IPM Procedures

Inspection and Preventive Maintenance Procedures
Procedure
Anesthesia Unit Vaporizers . . . . Anesthesia Unit Ventilators . . . . Anesthesia Units . . . . . . . . . . Apnea Monitors . . . . . . . . . . . Argon Surgical Lasers . . . . . . . Aspirators . . . . . . . . . . . . . . Autotransfusion Units . . . . . . . Beds, Electric . . . . . . . . . . . . Blood Pressure Monitors, Electronic Indirect . . . . . . . . . . . . . . Blood Pressure Monitors, Invasive Blood/Solution Warmers . . . . . . Capnometers and Multiple Medical Gas Monitors . . . . . . . . . . . Carbon Dioxide Surgical Lasers . . Cardiac Resuscitators . . . . . . . Centrifuges . . . . . . . . . . . . . Circulating-Fluid Pumps . . . . . . Conductive Furniture and Floors . Critical Care Ventilators . . . . . . Cryosurgical Units . . . . . . . . . Defibrillator/Monitors . . . . . . . Defibrillators . . . . . . . . . . . . ECG Monitors . . . . . . . . . . . . Electrical Receptacles . . . . . . . Electrocardiographs . . . . . . . . Electrosurgical Units . . . . . . . . Frequency-Doubled Nd:YAG Surgical Lasers . . . . . . . . . General Devices . . . . . . . . . . . Heart-Lung Bypass Units . . . . . Heated Humidifiers . . . . . . . . . Hemodialysis Units . . . . . . . . . Ho:YAG Surgical Lasers . . . . . . Hypo/Hyperthermia Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

No.
436-0595 461-0595 400-0595 420-0595 462-0595 433-0595 449-0595 402-0595

Procedure
Infant Incubators . . . . . . . . . . . Infusion Devices . . . . . . . . . . . Intra-Aortic Balloon Pumps . . . . . Isolated Power Systems . . . . . . . Laparoscopic Insufflators . . . . . . . Mammography Units . . . . . . . . . Medical Gas/Vacuum Systems . . . . Mobile C-arms . . . . . . . . . . . . Mobile X-ray Units . . . . . . . . . . Nd:YAG Surgical Lasers . . . . . . . Oxygen-Air Proportioners . . . . . . Oxygen Analyzers . . . . . . . . . . . Pacemakers, External Invasive . . . Pacemakers, External Noninvasive . Peritoneal Dialysis Units . . . . . . . Phototherapy Units . . . . . . . . . . Physical Therapy Ultrasound Units . Pneumatic Tourniquets . . . . . . . . Portable Ventilators . . . . . . . . . Pressure Transducers . . . . . . . . Pulmonary Resuscitators, Gas-Powered . . . . . . . . . . . . Pulmonary Resuscitators, Manual . . Pulse Oximeters . . . . . . . . . . . Radiant Warmers . . . . . . . . . . . Radiographic Units, General-Purpose Radiographic/Fluoroscopic Units, General-Purpose . . . . . . . . . . Smoke Evacuators . . . . . . . . . . Sphygmomanometers . . . . . . . . . Suction Regulators . . . . . . . . . . Temperature Monitors . . . . . . . . Traction Units . . . . . . . . . . . . . Transcutaneous O2/CO2 Monitors . . Ultrasound Scanners . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

No.
415-0595 416-0595 432-0595 439-0595 466-0595 467-0595 440-0595 463-0595 468-0595 447-0595 444-0595 417-0595 418-0595 460-0595 455-0595 469-0595 470-0595 443-0595 471-0595 435-0595 448-0595 422-0595 451-0595 419-0595 472-0595 473-0595 452-0595 424-0595 459-0595 425-0595 427-0595 453-0595 474-0595

. . . 454-0595 . . . 434-0595 . . . 445-0595 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 450-0595 446-0595 421-0595 456-0595 412-0595 441-0595 458-0595 457-0595 408-0595 407-0595 409-0595 437-0595 410-0595 411-0595 464-0595 438-0595 430-0595 431-0595 413-0595 465-0595 414-0595

257941 456-0595
A NONPROFIT AGENCY

5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275

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Procedure/Checklist 436-0595

Anesthesia Unit Vaporizers
Used For:
Anesthesia Unit Vaporizers [10-144]

Also Called: By trade names (e.g., Fluotec 5, Vapor 19.1, Tec 6), which are registered trademarks and should be used only when referring to the specific devices Commonly Used In: Operating rooms, emergency rooms, delivery rooms, trauma rooms, and any areas requiring the administration of an inhalation agent (with anesthesia units) Scope: Applies to the various anesthesia vaporizers used to deliver a known concentration of vaporized liquid anesthetic Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval* 6 months NA Interval Used By Hospital months months Time Required . . hours hours

* Additional periodic calibration and preventive maintenance is normally required annually or biannually (see manufacturer’s recommendation). Only qualified personnel trained and experienced in this function should perform this additional servicing.

Overview
An anesthesia unit vaporizer is used to vaporize a liquid anesthetic agent and deliver a controlled amount to the patient. According to the American Society for Testing and Materials (ASTM) standard ASTM F1161-88, anesthetic agent vaporizers are required to be concentration calibrated (i.e., a calibrated knob controls the output concentration). Older vaporizers, such as the Copper Kettle and the Vernitrol, do not have a single control for selecting the concentration of anesthetic vapor. Where possible, these units should be removed from service. Contemporary concentration-calibrated vaporizers are of two types: variable bypass and heated blender. Conventional (variable-bypass) vaporizers. In a variable-bypass vaporizer, the total background gas flow that enters the unit is split into two streams. The

smaller stream, which acts as the carrier gas, passes through the vaporizing chamber containing the anesthetic agent and becomes saturated with agent vapor; the remainder of the gas bypasses this chamber. A wick may be used in the vaporizing chamber to provide increased surface area for efficient evaporation of the drug and saturation of the carrier gas. The saturated carrier gas leaves the chamber and mixes with the bypass gas. One adjustment is made to set the desired concentration. This adjustment simultaneously balances the carrier and bypass flows to produce the blend required for the set concentration. The mixture exits the vaporizer and is delivered from the anesthesia machine as the fresh gas to be inspired by the patient. Evaporation of the liquid agent contained in the chamber is driven by heat absorbed from the walls of the vaporizer; consequently, when evaporation is occurring, the vaporizer and its contents cool. Because the equilibrium vapor pressure of an agent changes

009006 436-0595
A NONPROFIT AGENCY

5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275

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Inspection and Preventive Maintenance System
pass vaporizer. As a result, the variable-bypass design was abandoned for desflurane, and Ohmeda developed a new vaporizer, the Tec 6, based on a heated-blender design. Figure 2 shows a schematic of this vaporizer. A version of the Tec 6 (also manufactured by Ohmeda) has been adapted for Drager machines and is compatible with the Drager triple-exclusion interlock system. As of this writing, neither Drager nor Siemens has developed its own desflurane vaporizer. A desflurane vaporizer requires electrical power to heat the agent to a thermostatically controlled 39°C, producing a stable, saturated vapor pressure of 1,500 mm Hg. No wick is used, and no carrier gas enters the sump chamber. Instead, a stream of vapor under pressure flows out of the sump; this stream blends with the background gas stream, which originates from the anesthesia machine’s flowmeters, to achieve the desired concentration. The background gas stream passes through a fixedflow resistor, producing a back pressure upstream of this resistor that is proportional to the background gas flow. The desired desflurane concentration is set on the dial of the adjustable metering valve in the vapor stream; this setting produces a predetermined aperture. The pressure in the vapor upstream of the aperture and the back pressure in the background gas stream are continually sensed by a differential pressure transducer. The transducer controls a pressureregulating valve in the vapor stream between the sump

Figure 1. Schematic illustrating the basic elements of a vaiable-bypass vaporizer with temperature, a temperature-sensitive mechanism is used to automatically adjust the carrier and bypass flows to compensate for temperature changes. Figure 1 presents a schematic of a variable-bypass vaporizer. Desflurane (heated-blender) vaporizers. Desflurane, a volatile inhalation anesthetic marketed by Ohmeda Pharmaceutical Products Division under the trade name Suprane, has characteristics that differ markedly from those currently in use — enflurane, halothane, and isoflurane; for example, its low solubility allows rapid induction of and emergence from anesthesia. Thus, by increasing the speed of recovery, desflurane has the potential to shorten hospital stays (although this has not yet been consistently demonstrated). The boiling point of desflurane — 22.9°C at 760 mm Hg — is just above room temperature; therefore, small increases in ambient temperature or decreases in atmospheric pressure can cause it to boil. Also, because of desflurane’s high minimum alveolar concentration, or MAC (i.e., its low potency), evaporation of sufficient agent to achieve a given anesthetic effect would require much more heat absorption from the vaporizer than occurs with other agents. Furthermore, the change in vapor pressure of desflurane per change in temperature is as much as three times that for the other volatile agents at sea-level atmospheric pressure. These profound effects of temperature and ambient pressure on the vapor pressure of desflurane make stabilizing the delivered concentration at a set point extremely difficult in a passive mechanical system, such as a variable-by-

Figure 2. Schematic illustrating the basic elements of the Ohmeda Tec 6 vaporizer

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Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

Anesthesia Unit Vaporizers
and the adjustable metering valve. The pressure-regulating valve permits only that flow from the sump necessary to cause the pressure upstream of the adjustable metering valve to equal the back pressure in the background gas stream. In this way, the ratio of the adjustable metering valve’s resistance to the resistance of the fixed-flow resistor determines the ratio of the flows in each stream, and therefore, the concentration of vapor in the blended output. If the flow from the anesthesia machine’s flowmeters through the vaporizer is altered, the flow of vapor from the sump is automatically adjusted so that the pressures at the two monitored points remain equal, the flow ratio does not change, and the output concentration continues to match its setting. The control circuits and heating elements in the vaporizer are turned on by the act of connecting the vaporizer to electrical power. The unit then heats to and remains at operating temperature as long as it receives power, whether it is delivering agent or is in the standby mode. Consequently, it is warm to the touch while plugged into a live socket. Do not fill a vaporizer with an inhalation agent unless you are qualified to do so. Always use a scavenging system or appropriate ventilation when inspecting vaporizers. For personal safety, when inspecting vaporizers alone, notify other personnel of your location. Be sure that filler ports are tightly capped before passing gas through the vaporizer.

Procedure
Before beginning an inspection, carefully read this procedure and the manufacturer’s instruction and service manuals; be sure that you understand how to operate the equipment and the significance of each control and indicator. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Note: This procedure should be done simultaneously with Anesthesia Units Procedure/Checklist 400, where leak testing of the vaporizer has been included with the anesthesia unit. Each vaporizer should have a separate control number. Inspection documentation for up to three vaporizers (on one anesthesia unit) can be included on one inspection form (record each control number), but some hospitals may prefer to use a separate form for each vaporizer. Be sure that the anesthesia system is level and secure. Check that all hoses and fittings are tight.

Citations from Health Devices
Avoiding anesthesia mishaps through pre-use checks, 1982 May; 11:210-3. Water in halothane vaporizers [Hazard], 1985 Aug; 14:326. Anesthesia units with a flowmeter-controlled vaporizer [Hazard], 1986 Dec; 15:336. Vaporizer leak with Mapleson breathing circuits [Hazard], 1986 Dec; 15:344-5. Concentration calibrated vaporizers [Hazard], 1987 Mar-Apr; 16:112-3. Pre-use anesthesia check fails to find faults [Hazard], 1988 Sep; 17:274-6. Desflurane (Suprane): Considerations for introducing the new inhalation anesthetic agent into clinical practice [Guidance article], 1994 Apr; 23:131-42.

1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that housings are intact, that all assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. Check security of mounts or support mechanisms. Verify that the vaporizer is firmly mounted on the anesthesia unit. AC Plug. If the unit is so equipped, examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Line Cord. Inspect the cord, if so equipped, for signs of damage. If damaged, replace the entire cord, or if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the same polarity as the old one.

1.2

1.4

Test apparatus and supplies
Halogenated anesthetics analyzer Hoses and adapters

Special precautions
As a general precaution, a vaporizer containing an anesthetic agent should not be tipped. If such tipping occurs, notify the user and follow the manufacturer’s recommended procedures for airing or drying the unit.

1.5

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

3

Inspection and Preventive Maintenance System
1.6 Strain Reliefs. Examine the strain reliefs at both ends of the line cord, if so equipped. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the device has a switch-type circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare fuse is provided. Tubes/Hoses. Check the condition of all tubing and hoses. Be sure that they are not cracked, kinked, or dirty. manual or automatic) against the manufacturer’s specifications. Check that the vaporizer interlock allows activation of only one vaporizer at a time. 1.21 Audible Signals. Operate the device in such a way as to activate any audible signals. Confirm appropriate volume, as well as the operation of a volume control, if so equipped. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible. 1.24 Site Glass, O-Rings, Keyed Filler Mechanism. Examine the physical condition of the site glass, O-rings, and keyed filler mechanism, if so equipped.

1.7

1.8

1.10 Fittings/Connectors. Examine all gas and liquid fittings and connectors for general condition. Be sure all fittings are tight. 1.13 Controls. Before moving any controls, check their positions. If any of them appear inordinate or are left in the on position, consider the possibility of inappropriate clinical use or of incipient device failure. Examine all controls for physical condition, secure mounting, and correct motion. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. During the course of the inspection, be sure to check that each control performs its proper function. Return all controls to the off position following the test. 1.16 Fluid Levels. Check all fluid levels. If the fluid level is zero, we recommend that you have a qualified user fill the sump with anesthetic agent to continue the inspection. 1.17 Battery. Inspect the physical condition of the battery and battery connectors, if so equipped and readily accessible. Operate the battery-powered functions of the unit for several minutes to check that the battery has an adequate charge. Check remaining battery capacity by activating the battery test function or measuring the output voltage. If it is necessary to replace a battery, label it with the date. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all indicators and visual displays on the unit, if so equipped. 1.20 Alarms/Interlocks. Operate the device in such a way as to activate each audible and visual alarm, if so equipped. If the device has an alarmsilence feature, check the method of reset (i.e.,

2. Quantitative tests
2.1 Grounding Resistance. If the unit is electrically powered, use an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms to measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal of the chassis. We recommend a maximum of 0.5 Ω Leakage Current. For electrically powered units, measure chassis leakage current to the chassis of the device with the grounding conductor of plug-connected equipment temporarily opened. Operate the device in all normal modes, including On, Standby, and Off, and record the maximum leakage current. Leakage current should not exceed 300 µA.

2.2

2.10 Concentration Check. Data for up to three vaporizers can be recorded as Items 2.10, 2.11, and 2.12. Record the type and control number of the vaporizer being tested under each item. 2.11 See Item 2.10 2.12 See Item 2.10 Because there are various types of halogenated anesthetic analyzers, follow the manufacturer’s procedure for setup and use of the analyzer. Vaporizers should usually be tested with an oxygen flow of 4 to 5 L/min (nitrous oxide may affect the readings of some vapor analyzers). Test the vaporizers at low, medium, and high concentration settings in the normal clinical use range (e.g., 0.5%, 1.0%, and 3.0% for halothane).

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Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

Anesthesia Unit Vaporizers
At one concentration setting (e.g., 1.0% for halothane, 10% for desflurane), test the vaporizer at another flow (e.g., 1 L/min). We recommend that the concentration be ±0.3% vapor or ±10% of the measured value, whichever is greater. If errors in concentration are observed, allow the vaporizer to operate for a minute or two and recheck the unit. Some units may require a short stabilization period. 3.2 Replace the battery, if so equipped (battery should be replaced at least once annually).

4. Acceptance tests
Conduct major inspection tests for incoming vaporizers and, if a vaporizer is position sensitive, any time it is demounted from an anesthesia unit.

Before returning to use
Return all controls to the off position, level and secure the unit, and tighten all fittings and tubing.

3. Preventive maintenance
3.1 Clean the exterior.

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

5

Procedure Checklist 461-0595

Anesthesia Unit Ventilators
Used For:
Anesthesia Unit Ventilators [10-145]

Commonly Used In: Delivery rooms and operating rooms Scope: Applies to ventilators used to deliver inhalation anesthetic agents during surgical procedures that require general anesthesia Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 6 months* NA Interval Used By Hospital months months Time Required . . hours hours

* Inspection and preventive maintenance intervals should be scheduled according to the manufacturer’s recommendations. However, units should have a major inspection at least every six months. Pre-use checks should be performed before each case by the anesthetist who will be operating the equipment.

Overview
Patients undergoing surgery under general anesthesia are routinely paralyzed with muscle relaxants to stabilize the surgical field. Consequently, they are unable to breathe on their own and must be mechanically ventilated either manually by the anesthetist, who squeezes a reservoir bag in the breathing circuit, or automatically by an anesthesia ventilator. A switch valve allows the choice of the method by which ventilation is to be supported. The anesthesia ventilator is typically turned on and off independently of the switching between manual and automatic ventilation. Anesthesia ventilators use positive pressure to inflate a patient’s lungs and deliver a prescribed mixture of gases and vapors to them. This mixture is produced by the anesthesia machine. The ventilator can be built into the anesthesia machine or can be a stand-alone unit connected to the machine by gas tubing and, perhaps, sensor cables. Some anesthesia ventilators have built-in displays and alarms; others rely on the sensors, displays, and alarms of the anesthesia machine to monitor their performance.

In general, an anesthesia ventilator is less sophisticated than a critical care ventilator, having only a control mode of operation, with time cycling. (However, there is at least one ICU-type ventilator that can be used to administer inhalation anesthetics.) A pressure limit prevents exposure of the lungs to excessive pressure. Several other breathing waveshape parameters (e.g., inspiratory:expiratory [I:E] ratio, tidal volume, minute volume, flow) are settable by the operator and controlled by the ventilator. Ventilators designed solely for anesthetic administration typically do not have compressors. During extended procedures and procedures involving open breathing circuit configurations, a humidifier may be included in the breathing circuit. Otherwise, a circle system with an absorber, along with one-way inspiratory and expiratory valves, is used, typically without a humidifier. The ventilator’s pressure-relief and limit valve(s) should be connected to a waste gas scavenging system.

Citations from Health Devices
Anesthesia systems [Evaluation], 1988 Jan; 17:3.

238369 461-0595
A NONPROFIT AGENCY

5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275

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enables easy production of customized procedures and checklists for specific ventilator models and clinical needs. 1994 Jan-Feb. Risk of barotrauma and/or lack of ventilation with ventilatorless anesthesia machines [Hazard]. 17:354. if so equipped. examine the condition of the mount.Inspection and Preventive Maintenance System Who should service anesthesia equipment [User Experience NetworkTM]. If damaged. AC Plug. check the security of this attachment.) IPM Task ManagerTM. References to specific pages of the manufacturer’s manual should be added to the checklist. Check that they are connected to the correct locations. Manufacturers’ recommended procedures should be added where appropriate. the software component of the Inspection and Preventive Maintenance System. Strain Reliefs. check its value and type against that marked on the chassis. 1988 Nov. kinked. Damage to elastic components from Loctite [Hazard]. if the damage is near one end. check that it moves freely. In addition. a separate checklist for 1. check their condition. or dirty. Examine the exterior of the unit for cleanliness and general physical condition. If any damage is suspected. 18:288. Check the mounting security of all components. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Mount/Fasteners. if the unit is so equipped. Circuit Breaker/Fuse. and ensure that a spare is provided. ventilator controls can vary greatly among manufacturers and models. 23:54.1 Chassis/Housing. Check that ventilators mounted in anesthesia machines are properly installed.3 1. Also check line cords of battery chargers. The following framework should be supplemented by the manufacturer’s recommended preventive maintenance procedures for mechanical ventilators. 1989 Jul-Aug.7 1. 1.4 1. Manufacturers’ recommended procedures for inspection and preventive maintenance of mechanical anesthesia ventilators vary in both methods and required accuracy. Examine the AC power plug for damage. and the alarm capabilities. (The checklist includes blank spaces for the insertion of these reference numbers. Items performed by outside vendors can be excluded from the checklist. Line Cord. Be sure to wire a new power cord or plug with the correct polarity. Barotrauma from anesthesia ventilators [Hazard]. be sure that you understand how to operate the equipment.6 1. Tubes/Hoses.5 1. Check the operation of brakes and swivel locks. Be sure that they hold the cord securely. If the device is mounted on a stand or cart. If the device moves on casters. Attempt to wiggle the blades to check that they are secure. if so equipped. that all hardware is present and tight.8 2 Inspection and Preventive Maintenance System ©1995 ECRI. Shake the plug and listen for rattles that could indicate loose screws. Be sure that they are not cracked. If it is attached to a wall or rests on a shelf. use by outside vendors can be produced to ensure that those items agreed upon are performed by the vendor. . If the device is protected by an external fuse. Examine the strain reliefs at both ends of the line cord. carefully read this procedure and the manufacturer’s instruction and service manuals. 1988 Feb. Test apparatus and supplies Lung simulator with adjustable compliance or ventilator tester Pressure gauge or meter with 2 cm H2O resolution from -20 to +120 cm H2O Various breathing circuit adapters Leakage current meter or electrical safety analyzer Ground resistance ohmmeter Additional items as required for specific manufacturers’ procedures 1. 17:70. and that there are no signs of spilled liquids or other serious abuse. the significance of each control and indicator. Check the condition of all tubing and hoses. This procedure provides the basic framework for complete ventilator inspection and preventive maintenance. Verify that they turn and swivel. as appropriate. Inspect the cord for signs of damage. open the plug and inspect it. if so equipped. and look for accumulations of lint and thread around the casters. All Rights Reserved. Qualitative tests 1. If the device has a switchtype circuit breaker. Be sure that plastic housings are intact. cut out the defective portion. replace the entire cord or. Casters/Brakes.2 Procedure Before beginning an inspection.

Check that any associated interlocks function. and correct motion.20 Alarms/Interlocks. 1. gauges. 1. Record the settings of those controls that should be returned to their original positions following the inspection. check for proper alignment. Check physical condition and proper operation. Operate the unit on battery power for several minutes to check that the battery is charged and can hold a charge. Examine all gas fittings and connectors for general condition. meters. to the extent possible. 2. manual. Confirm the presence and condition of accessories. for sensors) and their strain reliefs for general condition.24 Bellows. Clean or replace if appropriate. pens). and that keying is correct.22 Labeling. 1. 1.g.Anesthesia Unit Ventilators 1. Gas fittings should be tight and should not leak. Before changing any controls or alarm limits. Check the condition of gas filters. and indicate this on Lines 3. indicators.1 and 3. Check the condition of the battery charger and.17 Battery/Charger.. Induce alarm conditions to activate audible and visual alarms. and visual displays on the unit and charger (if so equipped).. 1. or solid particle contaminants in the gas supply. gaseous.. electrical safety analyzer. 1.1 and 3. Check operation of battery-operated power-loss alarms. 1. according to the manufacturer’s instructions. that all pins are in place and secure.e. Check the physical condition and proper operation of the bellows. Check for corrosion residue indicative of liquid. consider the possibility of inappropriate clinical use or of incipient device failure.18 Indicators/Displays. as well as positive stopping.4.1 Grounding Resistance. (The inspection can be carried out on battery power to help confirm adequate battery capacity. if available. Connectors to hospital central piped medical gas systems should have the appropriate DISS or quick-connect fitting to eliminate the need for adapters. if present. Be sure that the battery is recharged or charging when the inspection is complete. pin-indexed gas connectors) are used where appropriate. Verify that any remote alarm indicator (e. Where appropriate. measure the specific gravity and check the fluid level. within the mainframe anesthesia unit) functions properly. 1. labels. If the unit has an alarm-silence feature.12 Filters.. for lead-acid batteries. 3 . automatic) against the manufacturer’s specifications.13 Controls/Switches.g. if so equipped.9 Cables.4 of the inspection form.g. Examine all controls and switches for physical condition. It may not be possible to check out all alarms at this time since some may require special conditions that must be established according to the manufacturer’s recommendations.. Verify that keyed connectors (e.g. alarm limits at the ends of their range). from fingernails. Check that all necessary placards. label it with the date. Check that control knobs have not slipped on their shafts. secure mounting. measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis of the ventilator or of Inspection and Preventive Maintenance System ©1995 ECRI. Inspect the physical condition of batteries and battery connectors. if found. check their positions.g. confirm the operation of all lights. 1. and note this on Lines 3. If any settings appear inordinate (e. Quantitative tests 2. When it is necessary to replace a battery.23 Accessories. Clean and lubricate if required. confirm that it does. be sure to check that each control and switch performs its proper function. During the inspection. if so equipped. Check the condition of reusable Bain circuit and adapters. All Rights Reserved.2 of the form. Where a control should operate against fixed-limit stops.) Check battery condition by activating the battery test function or measuring the output voltage. charge the battery. verify that there are no intermittent faults by flexing cables near each end and looking for erratic operation or by using an ohmmeter. or multimeter with good resolution of fractional ohms. notify appropriate personnel. Be sure that all segments of a digital display function. include these in Item 2. 1. Check membrane switches for damage (e. During the course of the inspection. Inspect any cables (e. Carefully examine cables to detect breaks in the insulation and to ensure that they are securely gripped in the connectors at each end. if so equipped and if readily accessible. which will prevent rotation or other strain. in fact.10 Fittings/Connectors. Record the reading of an hour meter. and instruction cards are present and legible. Using an ohmmeter. check the method of reset (i. if included in the unit..15 Fan.

the absence of obstructions. see Oxygen Analyzers Procedure/Checklist 417) Alarm settings (e. breath rate. minute volume. Check for leaks. This includes other equipment that is plugged into the primary device’s accessory receptacles. standby. Pneumatic lines (including air filters). including on. PIP. Chassis leakage current to ground should not exceed 300 µA.3 Modes and Settings. inspiratory time. rate. The manufacturer should recommend the appropriate ventilator settings (e. 2. and record the maximum leakage current. as well as equipment plugged into a multiple-outlet strip (“Waber strip”) so that all are grounded through a single line or extension cord. The function of these modes should be inspected and verified for proper operation. Check the operation and accuracy of ventilation controls. However. adapters. Breathing circuit (including filters). and in good condition and that there is an adequate gas supply. ensuring the proper assembly and function of fittings. check for leaks in the entire system. these tests are performed by attaching the ventilator to a lung simulator or ventilator tester and comparing measured values to settings on the ventilator. low pressure. the CO2 absorber. the APL valve.g. 2. Check the proper operation of the pressure-relief mechanism by occluding the breathing circuit and measuring the resulting peak pressure on the pressure gauge. If the ventilator is a component within an anesthesia unit. Absorber. 17:109). grounding and leakage current measurements can be referenced to that unit. pressure limit. The following breathing circuit parameters may be monitored by the ventilator or by the system in which the ventilator is mounted. 2. Typically. expiratory time. This does not have to be duplicated if done as part of the Anesthesia Units procedure (see Procedure/Checklist 400). apnea) Volume (e. Verify that appropriate gas-specific connectors are used.5 Gas Supply. apnea) Fraction of inspired oxygen (FIO2. PEEP. MAP. Pressure-Relief Mechanism. Check gas filters.6 Patient Circuit. high PIP. Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off. Monitors and Alarms. We recommend a maximum of 0. Verify that pressure is vented in the breathing circuit. including the breathing circuit. Verify that one and only one washer is used to seal the tank to its yoke. Adjustable positive end-expiratory pressure (PEEP) may also be available. All Rights Reserved. Verify that these components are compatible with the ventilator according to the manufacturer’s recommendations (see Health Devices 1988 Apr.. Humidifiers. specialized units may have additional modes such as assist/control and pressure support. if so equipped). 2. They should be inspected for accuracy (generally within 10%) according to the manufacturer’s specifications: Breathing rate Inspiratory time Airway pressure (e. if so equipped and accessible.4 4 Inspection and Preventive Maintenance System ©1995 ECRI.g.. . low FIO2) should be inspected for proper and accurate activation.5 Ω.2 Leakage Current. and off. See Anesthesia dure/Checklist 400. See Heated Humidifiers Procedure/Checklist 431. I:E ratio. Operate the device in all normal modes. tidal volume. tidal volume. Verify that these are present. With the ventilator connected to the anesthesia system..g. inspiratory time) to verify proper operation and accuracy (generally within 10%).g. Anesthesia ventilators are usually equipped only with a control mode. low MAP. Units Proce- 2. which may include tidal volume. Verify that all index pins are present and protruding to the proper length to engage the hole in the tank valve stem and in the correct positions for the gas to be supplied through the yoke. and other components. Gas cylinders (and gauges and regulators. the scavenger. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened.. inspiratory and expiratory valves and PEEP valves. and proper flow direction in the breathing circuit.Inspection and Preventive Maintenance System the system in which the ventilator is mounted. or flow. securely mounted.

4 Clean the exterior and interior. Calibrate according to manufacturer’s instructions. or equip them with fresh batteries. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.3 3. Inspection and Preventive Maintenance System ©1995 ECRI. if needed. 4. 5 . Preventive maintenance 3. Replace components according to the manufacturer’s instructions. All Rights Reserved. Other controls should be in their normal pre-use positions. Set alarms loud enough to alert personnel in the area in which the device will be used.Anesthesia Unit Ventilators 3. Attach a Caution tag in a prominent position so that the user will be aware that control settings may have been changed. Recharge battery-powered devices. if needed.1 3. Before returning to use Ensure that all controls are set properly.

the vaporizers. the patient is anesthetized by a narcotic or barbiturate injection followed by administration of an inspired gas mixture of oxygen. refer to Conductive Furniture and Floors Procedure/Form 441). as well as add anesthetic agents to the OR atmosphere. Type Major Minor ECRI-Recommended Interval 6 months NA Interval Used By Hospital months months Time Required . consult the manufacturer before inspecting an anesthesia unit. If respiratory assist is necessary (e. Plymouth Meeting. other monitors. a ventilator may be connected to the patient breathing system to force the gas mixture into the patient’s lungs. and misconnected or improperly calibrated flowmeters have also caused anesthesia-related accidents. and the vapor of a volatile liquid anesthetic. Inadvertent switching of gas supplies. nitrous oxide. typically a halogenated hydrocarbon. in cases of muscular blockade). Improperly modified or inadequately maintained anesthesia units have injured and killed patients and hospital personnel. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. delivery rooms. emergency departments.org . The anesthesia unit administers this mixture of anesthetic gases and life-sustaining oxygen. does not apply to oxygen monitors with an alarm.g. anesthesia workstations Commonly Used In: Operating rooms. failure of an alarm to respond to an excessively low oxygen pressure. Gas leaks can adversely affect the accuracy of gas delivery to the patient. Gas supply. any areas where anesthetic agents are used Scope: Applies to anesthesia units. varying the proportions to control the patient’s level of consciousness. includes leak testing of vaporizers and should be used in conjunction with Anesthesia Unit Vaporizers Procedure/Checklist 436 (in the very rare case where an anesthesia unit may still use flammable anesthetic agents. . Trace levels of anesthetics have been implicated as a health hazard to chronically exposed OR personnel and unborn children.. Hospital Assessment. life-support devices such as anesthesia units should be operated and inspected only by qualified personnel who have a thorough knowledge of the units and their functions. High. Because mishandling and mistakes can have severe consequences. The anesthesia unit consists of four systems: the gas supply system. hours hours Overview Most surgical procedures are performed while the patient is under general anesthesia. or ventilators that might be part of the breathing system (see Anesthesia Unit Ventilators Procedure/Checklist 461) Risk Level: ECRI Recommended. Cylinders containing oxygen and other gases at high pressure (see Table 1) are connected to the high-pressure system of the anesthesia unit by 009005 400-0595 A NONPROFIT AGENCY 5200 Butler Pike. the gas control system. If you are unsure of any aspect of the procedure.Procedure/Checklist 400-0595 Anesthesia Units Used For: Anesthesia Units [10-134] Also Called: Anesthesia machines. spirometers. and the breathing system. This system delivers a variety of gases to the patient. Usually. trauma rooms. PA 19462-1298.

anesthetic agent vaporizers are required to be concentration calibrated (i. . According to the American Society for Testing and Materials (ASTM) standard ASTM F1161-88.. psi 21°C. The flow of each gas is controlled by a valve and indicated by a glass-tube flowmeter. Pin-index safety system 2 Inspection and Preventive Maintenance System ©1995 ECRI. Green Gray Blue Brown Yellow Color Code: International White Gray Blue Brown White and Black Service Pressure.S. Chemical Formula O2 CO2 N2O He Color Code: U. Some units may provide an oxygen power outlet to drive auxiliary devices (e. they can be administered to the patient. desflurane) to the gas mixture. This system regulates gas flow rates so that the gases can be mixed and delivered under accurate.HE (He > 80%) O2 .CO2 (CO2<7%) O2 . A fail-safe provision in many anesthesia units protects the patient against a fall in pressure of life-sustaining oxygen.800 yoke fittings that comply with the Compressed Gas Association (CGA) pin-index safety system (see Figure 1). Centrally supplied gases are delivered directly to the intermediate-pressure gas control system at approximately 50 psi through low-pressure hoses and connectors. sevoflurane. Newer anesthesia machines have additional safety systems that provide a minimum percent of oxygen (around 25%) and/or deliver a minimum flow of oxygen (usually 150 to 250 mL/min) (see Item 2. If the oxygen pressure drops below about 25 to 30 psi. a calibrated knob controls the Gas Oxygen Nitrous Oxide O2 .Inspection and Preventive Maintenance System TABLE 1.CO2 (CO2>7%) O2 . Gas control. Because oxygen and nitrous oxide are used in relatively large quantities. Inside the unit.HE (He < 80%) Air Index Pins 2-5 3-5 2-6 1-6 4-6 2-4 1-5 CGA Connector Number 870 910 880 940 930 890 950 Figure 1. However.. All Rights Reserved.11).800-2. isoflurane. The operator must be able to adjust the ratios or make rapid gross changes in flow rates without inducing system interactions that cause temporary delivery of undesirable mixtures.600-2. some units shut off the flow of all other gases. and aid in controlling the vapor concentration. Gases Used in Anesthesia Machines Gas Oxygen Carbon Dioxide Nitrous Oxide Helium Air * Depends on cylinder size. when desired. they are usually drawn from the hospital’s central gas supplies. which are more convenient and economical than compressed-gas cylinders. Unique placements of pins and mating holes on the pin-index fittings prevent connection of a gas cylinder to the wrong inlet.g. and a regulator that reduces the pressure to approximately 45 psi. Vaporizers. but each is designed to prevent mismating the gas supply and the machine inlet. each high-pressure gas flows through a filter. cylinders of these gases are also normally attached to the anesthesia unit as a reserve source if the central supply fails or if central supply outlets are not available.e. enflurane. These connectors may not comply with a universal standard safety system. These devices add the vapor of a volatile liquid anesthetic (e.000* 1. while others reduce all gas flow rates in proportion to the drop in oxygen pressure. a check valve (for one-way flow). halothane. a ventilator).g.. After gases pass the control valve and enter the low-pressure system. constantly metered control.400* 838 745 1. Full Cylinder 1.

desflurane and sevoflurane have the potential to shorten hospital stays. The breathing system typically includes a scavenging system to remove waste gases. Fresh gases from the anesthesia machine enter at one point. The variable-bypass (conventional) vaporizer is used for most volatile agents (e. Anesthesia units either come with physiological monitors integrated into the unit or provide shelving to support such monitors. Thus. halothane. and neoplastic disease and may affect the mental and physical abilities of exposed personnel. along with storage for drugs. which originates from the anesthesia machine’s flowmeters. En route. A wick may be used in the vaporizing chamber to provide increased surface area for efficient evaporation of the drug and saturation of the carrier gas. halothane.500 mm Hg. No wick is used. and pass to the patient. It requires electrical power to heat the agent to a thermostatically controlled 39°C. The saturated carrier gas leaves the chamber and mixes with the bypass gas. The patient breathes the anesthetic mixture directly from the machine. mix with previously exhaled gases. All Rights Reserved. efficient gas delivery to the patient. The mixture exits the vaporizer and is delivered from the anesthesia machine as the fresh gas to be inspired by the patient. T-piece systems that do not include the nonrebreathing valve may allow partial rebreathing. The breathing system should be checked before each use for leaking gases. if required.Anesthesia Units output concentration). these units should be removed from service. which acts as the carrier gas. do not have a single control for selecting the concentration of anesthetic vapor. Newly exhaled gases are channeled to a carbon dioxide absorber. Contemporary concentration-calibrated vaporizers are of two types: variable bypass and heated blender. which removes almost all the carbon dioxide produced by body metabolism and routes the scrubbed gases back toward the patient. their low solubilities allow rapid induction of and emergence from anesthesia. Instead. saturated vapor pressure of 1. depending on the inflow of fresh gas. this stream blends with the background gas stream. The patient inhales from and exhales into the system.) Breathing system. Inspection and Preventive Maintenance System ©1995 ECRI. isoflurane. the remainder of the gas bypasses this chamber. It is also recommended that the concentration of waste anesthetic gas in the operating room be surveyed quarterly. such as the Copper Kettle and the Vernitrol. A scavenging system should be included to remove waste gas from the vent port of a T-piece breathing system or from the adjustable pressure-limiting (APL) valve and relief valve of a ventilator of a circle system to reduce the quantity of gas that escapes into the operating room. to achieve the desired concentration. Although it is designed primarily for sustained. 3 . The scavenging system must include pressure-relief mechanisms so that abnormal pressures cannot develop in the scavenging system and interfere with operation of the breathing system. A heated-blender vaporizer is used only for desflurane. and exhaled gas is vented out of the system. The total background gas flow that enters the unit is split into two streams. although this has not yet been consistently demonstrated. For example. enflurane. Such a scavenging system is necessary because trace levels of anesthetics are believed to cause an increased incidence of spontaneous abortion. the scrubbed gases become mixed with fresh machine gases. (Desflurane. Most also provide mounting for a suction regulator and canister and other accessories. by increasing the speed of recovery. producing a stable. have characteristics that differ markedly from those currently in use — enflurane. Where possible. passes through the vaporizing chamber containing the anesthetic agent and becomes saturated with agent vapor. Older vaporizers.g. a stream of vapor under pressure flows out of the sump. congenital anomalies in offspring. the breathing system may also remove carbon dioxide and provide mechanical or manual ventilation of a patient who cannot breathe spontaneously. and related paraphernalia. This adjustment simultaneously balances the carrier and bypass flows to produce the blend required for the set concentration. a volatile inhalation anesthetic marketed by Ohmeda Pharmaceutical Products Division under the trade name Suprane. The circle or closed system is a continuous loop in which check valves allow gas to flow in only one direction. although they may assume a variety of configurations. marketed by Abbott under the trade name Ultane. and isoflurane. Two types of breathing systems are used to deliver the anesthetic mixture from the unit to the patient. and no carrier gas enters the sump chamber. sevoflurane). who inhales the mixture. and sevoflurane. The smaller stream.. The T-piece or open system may be a nonrebreathing system consisting of a reservoir bag and a gas-delivery hose connected through a nonrebreathing (one-way) valve to the face mask or endotracheal tube. as well as positive end-expiratory pressure (PEEP). One adjustment is made to set the desired concentration. supplies.

adjustments. the anesthetist. or ECRI before placing a unit into use. 1988 Feb. 1988 Sep. Use of inadequate (old) anesthesia scavenger interfaces [Hazard]. each cylinder on a unit that is ready for use should be more than half full if the gas is normally stored in gaseous form (e. To avoid the adverse effects of exposure to anesthetic gases. Trichloroethylene is a common solvent particularly recommended for cleaning oxygen fittings because it does not leave a residue that is flammable in high-concentration oxygen. When clean- Test apparatus and supplies Pressure gauge or meter. 22:592. Anesthesia units and breathing systems [Standard]. be sure all traces of the gas are cleared away before performing any electrical tests. 17:70-1. 16:112-3. this solvent reacts with the soda lime used in carbon dioxide absorbers to form several poisonous gases. including phosgene. Monitoring and anesthesia systems: integration and a new option. repairs. 41. have a minimum pressure of 745 psi for nitrous oxide and 1. 17:366-7. Anesthesia systems [Evaluation].. 1988 Dec. 20:131-2.000 psi for oxygen Nondisposable corrugated breathing hose (disposable tubing may not provide reliable connections) Test lung (reservoir bag with 3 or 5 L capacity) Sphygmomanometer bulb with tubing and adapter Leak-detecting solution Conductive lubricant for conductive casters (e.1 to 1. make sure that equipment recently cleaned with trichloroethylene is completely dry before using. When testing cyclopropane flowmeters.g. 17:3-34. including the gas cylinder stem valves. Who should service anesthesia equipment [User Experience NetworkTM]. Vaporizer leak with Mapleson breathing systems [Hazard]. Dow No. (Contains pre-use checklist for anesthesia units. 1987 May. Check that all valves. If a flammable anesthetic is used. 15:336-7. are turned off at the beginning of the inspection.Inspection and Preventive Maintenance System Citations from Health Devices Anesthesia units with a flowmeter-controlled vaporizer [Hazard]. 1989 Oct. Concentration calibrated vaporizers [Hazard]. Although concentrations may not be lethal. graphited oil) Trichloroethylene cleaning solvent or solvent recommended by the manufacturer (be sure to review the manufacturer’s Material Safety Data Sheet and see the special precautions below) Lubricant as specified by manufacturer Special precautions ECRI is aware of a number of incidents in which improperly serviced ventilation or anesthesia equipment was implicated in patient injury or death. To prevent the generation of these gases. However. -10 to +80 cm H2O (accuracy ±5 cm H2O at 30 cm H2O) Flowmeters with ranges of approximately 0. Do not perform any procedures. 1986 Dec. calibrated separately for each of the gases used with the anesthesia machine. and one flowmeter for 10 to 100 L/min (±10% of reading) Stopwatch or watch with a second hand Hoses and adapters for connecting pressure gauges or meters and flowmeters to equipment being inspected Cylinder of each type of gas used with the unit being inspected.) Anesthesia systems [Evaluation Update]. 15:344-5. 1988 Jan. cylinders should 4 Inspection and Preventive Maintenance System ©1995 ECRI. all testing should be done with an operating scavenging system in place or an alternative means to vent excess gases from the vicinity of inspecting personnel.g. or modifications unless you thoroughly understand the device and have verified the appropriateness of the intended actions. the presence of these gases to any degree is highly undesirable. oxygen) and should contain some liquid if the gas is normally liquefied for storage. Pre-use anesthesia check fails to find faults [Hazard]. 1993 Dec. All Rights Reserved. ±2% accuracy.0 L/min and 1 to 10 L/min. . 18:363. observe noted procedures to avoid a buildup of explosive levels of cyclopropane. 1986 Dec. 17:274-6. Anesthesia systems [Evaluation]. To be published in 1996. 16:178-9. 1987 Mar-Apr.. 1991 Mar-Apr. Turn all valves off again when the inspection is complete. Pre-use testing prevents “helpful” reconstruction of anesthesia components [Hazard]. Resolve any questions or uncertainties with the manufacturer.

Be sure to wire a new power cord or plug with the correct polarity. Check that appropriate keyed or indexed fittings are being used with corresponding gases. alarm limits at the ends of their range)..Anesthesia Units ing parts of the anesthesia unit with this solvent. Record the settings of those controls that should be returned to their original positions following the inspection. Cables.3 1. for general condition. Check that gas hoses do not lie on the floor or loop near the casters. a pressure alarm control at maximum. Tubes/Hoses. kinked.6 Strain Reliefs. 1. and bright. Examine the strain reliefs at both ends of the line cord. During the course of the inspection.4 of the inspection form. check its value and type against that marked on the chassis. and that there are no signs of spilled liquids or other serious abuse. Check the yoke clamping screw and make sure empty yokes have plugs. secure mounting. Check the condition of all tubing and hoses. replace the entire cord or. If any damage is suspected. as well as all electrical cable connectors and sockets. If damaged. Circuit Breaker/Fuse. that all assembly hardware is present and tight. Check any shelves. Attempt to wiggle the blades to determine that they are secure. if the damage is near one end. 1. Examine the AC power plug for damage. check for proper alignment. Examine the exterior of the unit for cleanliness and general physical condition.1 or 3. Be sure that they hold the cord securely. 1. 1. If the device is protected by an external fuse. and indicate this on Line 3. AC Plug/Receptacles. if the unit is so equipped.. Mount.4 Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved. sensor. and ensure that a spare is provided. electrode) and their strain reliefs for general condition. Examine all gas and liquid fittings and connectors. first disconnect the line to the carbon dioxide absorber. as well as positive stopping. Also check line cords of battery chargers.g. and be sure that they turn and swivel as appropriate. consider a full inspection of the receptacle. 5 .5 Line Cord. Before moving any controls and alarm limits. Check the operation of brakes and swivel locks.1 Chassis/Housing. 1.13 Controls/Switches. check their condition. Where a control should operate against fixedlimit stops. the significance of each control and indicator. clean. After cleaning. allow time for the solvent to evaporate. 1. brackets. be sure that you understand how to operate the equipment. Inspect the cord for signs of damage. Shake the plug and listen for rattles that could indicate loose screws.2 1. 1. If any of them appear inordinate (e. and correct motion. or supporting structures. If the device has electrical receptacles for accessories. carefully read this procedure and the manufacturer’s instruction and service manuals. cut out the defective portion. or dirty. Look for accumulations of lint and thread around the casters. be sure to check that each control and switch performs its proper function. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Be sure that plastic housings are intact. Inspect the cables (e. If accessories are plugged and unplugged often.7 Procedure Before beginning an inspection. Qualitative tests 1.g. When the parts appear dry. Check that pins used with the pin-index safety system comply (location and length of protrusion) and are intact.12 Filters.10 Fittings/Connectors. If the device has a switch-type circuit breaker. Examine all controls and switches for physical condition. take the added precaution of briefly flushing them with a high oxygen flow rate. Be sure that they are not cracked. Check the condition of all compressedgas filters. Check the security of the attachments. check their positions. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors of each end to prevent rotation or other strain. consider the possibility of inappropriate clinical use or of incipient device failure. open the plug and inspect it. insert an AC plug into each and check that it is held firmly. check that it moves freely. Clean or replace as needed.8 1. Electrical contact pins or surfaces should be straight. If the device moves on casters. Casters/Brakes. and the alarm capabilities.9 1. 1.

1. if so equipped. labels. and the flowmeter float should not move. Each valve should have a definite shutoff position at which the float should be motionless at its zero level. The control valve knob should require turning through at least 90° to change the flow rate from 10% to 100% of full scale. Check that the audible signals are appropriate for the test conditions used. and gently rocking the stem from side to side without rotation. check the method of reset (i. confirm that it does. 1. if the unit is so equipped. The stem should feel firm. With your hand occluding the expiratory port. Then. Inspect the physical condition of batteries and battery connectors. Confirm appropriate volume. Connect gas scavenging or other evacuation system to common gas outlet. and occlude the inspiratory port with the palm of your hand. Check for free play in the control valve by pushing. Open all cylinder stem valves and external gas source valves. Then disconnect or turn off all oxygen sources. The valve should turn smoothly with only slight drag.17 Battery/Charger. Reconnect the bag to the bag mount and the hose to the inhalation port. Check for the possibility of reverse flow through directional valves by removing the breathing hoses from the absorber and attaching a thin disposable reservoir bag to the exhalation port.) In addition to the automatic shutoff or reduction of gas flow. (Inspect ventilators. Check the battery-operated power-loss alarms on AC and pneumatic devices. The flow of other gases should fall or stop as the oxygen flow decreases to half its previous level. sphygmomanometer gauge). and visual displays on the unit and charger. gauges. The valves should flutter up and down and should not stick to their seats. if readily accessible. indicators. Be sure that all segments of a digital display function. close the APL valve. If the device has an alarm-silence feature. 1. manual or automatic) against the manufacturer’s specifications. if so equipped. Silence the 6 Inspection and Preventive Maintenance System ©1995 ECRI. check the condition of the battery charger and.19 Directional Valves. (Note: All recent anesthesia units should now have different sized and shaped knobs for oxygen and nitrous oxide to aid in differentiating between the two controls. blue for nitrous oxide). conversion charts..) 1.g.Inspection and Preventive Maintenance System Check that the concentration dial on each vaporizer moves freely and that only one vaporizer can be on at a time. if so equipped. Operate the device in such a way as to activate each audible and visual alarm. When it is necessary to replace a battery. Verify accuracy and function of any accessories (e. connect a test lung to the hose and generate about 5 cm H2O of pressure on the pressure gauge. and record on separate forms.21 Audible Signals. and open the flow control valves until the flowmeter for each gas reads midscale.. confirm the operation of all lights. If appropriate. All Rights Reserved. label it with the date. Check that directional valves are free from cracks and chips and fit smoothly against the valve seats.22 Labeling. Observe the float motion as its flow control valve is turned on. 1.e. Check for free movement by shaking or lightly squeezing the hose connecting the two valves. pulling. to the extent possible. green for oxygen. meters. All gas flow should cease when the oxygen flow reaches zero. and oxygen monitors separately using the appropriate procedures. 1. . Check that all necessary placards. Watch for any inflation of the flattened bag as a sign of expiratory valve leakage. 1. During the course of the inspection. Turn on the main gas control.23 Accessories. as well as the operation of a volume control. charge the battery. Check for proper color coding for corresponding parts (e. Attach a piece of hose to the bag mount. audible or visual alarms signifying low oxygen pressure should have been activated. spirometer.24 Fail-Safe Oxygen Valves and Alarms. Close all control valves. in fact. Check that any associated interlocks function (particularly the vaporizer interlocks.g.20 Alarms/Interlocks.. Operate the device in such a way as to activate all audible signals. and instruction cards are present and legible.) 1. Operate the unit on battery power for several minutes to check that the battery has an adequate charge. which should allow activation of only one vaporizer at a time). use a test lung to again generate about 5 cm H2O of pressure and check for inspiratory valve leakage by watching for any inflation of the bag.18 Indicators/Displays. Check remaining battery capacity by activating battery test function or measuring the output voltage. vaporizers. set the control for manual mode. (Cyclopropane flow rate normally falls more slowly than the others.

with all monitors and accessories connected to the unit’s accessory power receptacle(s). Attach the 100 L/min flowmeter to the common outlet. 2. Most anesthesia units manufactured after 1968 with mounted bubble-through vaporizers have a check valve in the gas delivery system to prevent pressures at the outlet (e. verifying that they are close to the service pressure values listed in Table 1. standby. On such devices. Measure chassis and patient lead leakage current to the chassis of the device with the grounding conductor of plug-connected equipment temporarily opened. replace it or alert appropriate personnel to replace the valve to avoid a possible hazardous buildup of vapor. 2. Low-Pressure Leaks. noting any motion of the flowmeter floats. All Rights Reserved. A sudden pressure drop suggests a leaky check valve. a partially occluded oxygen line in the machine. Turn off all vaporizers.) Disconnect the gas supply line hose from the machine. If the device has an accessory outlet. If the unit has an alarm that does not respond.4 High-Pressure Leaks. Intermediate Pressure System. Quantitative tests 2.6 Inspection and Preventive Maintenance System ©1995 ECRI. 2. Connect the hoses to the external pipeline gas source and test the supply line hoses with leak-detecting solution. and off. 2.25 Common Outlet Back-Pressure Check Valve. contact the manufacturer for instructions for testing the intermediate pressure system. attach the -10 to +80 cm H2O pressure gauge or meter to the common gas outlet. 7 . Set the oxygen flow rate to a 2 L/min indication on the machine’s oxygen flowmeter and actuate the oxygen flush control. either filled or empty. Open all cylinder stem valves one full turn. it should move smoothly and not have a tendency to stick. Record pressure gauge or meter readings. If it falls more than 1 L/min. Check that the oxygen flow returns to 2 L/min within 2 sec each time the flush valve is closed. Note: This test may not be possible on newer machines that always maintain a minimum flow of oxygen. produced by a ventilator) from being transmitted to other parts of the unit where they could affect the accuracy of gas delivery and the concentration of anesthetic gases. check for an inadequate oxygen supply. (Most machines should have such a gauge. check its grounding to the main power cord. follow the manufacturer’s instructions for testing the common outlet back-pressure check valve.5 2. Close the cylinder stem valves. Excess pressure drop indicates an unacceptable leak that should be located and repaired. The machine flowmeter indication should remain near 2 L/min unless the manufacturer’s specification shows otherwise. This includes other equipment that is plugged into the primary device’s accessory receptacles.Anesthesia Units alarm by raising the oxygen pressure above the preset alarm limit. to maintain 30 cm H2O. Turn on the vaporizer flow..5 Ω. If the check valve is missing or defective. If not. and check that the pressure drop in 30 sec is negligible. or multimeter with good resolution of fractional ohms to measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. Use an ohmmeter. Close all flow control valves on the anesthesia unit. and readjust. Note the pressure on the pipeline/central gas supply pressure gauge. We recommend a maximum of 0. electrical safety analyzer.g. Leakage current should not exceed 300 µA. Attach the -10 to +80 cm H2O pressure gauge or meter to the unit’s common 2. including on.3 Oxygen Flush Valve.2 Leakage Current. Close all flow control valves on the machine. or a dirty oxygen inlet filter. Cycle the flush control slowly several times. Carefully open the vaporizer filler cap (to prevent a sudden flow of oxygen into the vaporizer) and observe the outlet gauge pressure. as well as equipment plugged into a multiple-outlet strip (“Waber strip”) so that all are grounded through a single line or extension cord. 1. Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off. The rate should rise to between 35 and 75 L/min. To test this check valve. if necessary. check for exhausted batteries or other source of the malfunction. Excessive pressure drop indicates an unacceptable leak that should be located and repaired. Operate the device in all normal modes. Float movement indicates a leaky flowmeter valve. The pressure drop over 30 sec should be negligible. and record the maximum leakage current.1 Grounding Resistance. Adjust the oxygen flow control valve to maintain an outlet pressure of 30 cm H2O.

Use the bulb to pressurize the breathing system to 50 cm H2O. (Connect a flowmeter to the common gas outlet if necessary. check for dust in the inspiratory valve and piping. For anesthesia units for which low flow rates cannot be generated (units that deliver minimum flows of oxygen). All Rights Reserved. and inspect the gaskets for any absorbent dust and wear. For anesthesia systems without minimum oxygen flows. 2. Locate the leak by shutting off all vaporizers and repeating the test with each vaporizer added in turn. turn the anesthesia machine off and connect the -10 to +80 cm H2O pressure gauge or meter to a piece of breathing system tubing that is connected to the inspiratory and expiratory valve outlets. With the scavenging system operating at maximum suction. the leakage rate is excessive. Leave the setup as in Item 2.) If the gauge or meter pressure continues to rise. the low-pressure system can be tested in combination with the breathing system. the leak rate is less than 30 mL/min at 30 cm H2O (10 mL/min at 10 cm H2O). If the amount of dust seems excessive or if the canister appears seriously pitted. and report the condition to department personnel. 2. 8 Inspection and Preventive Maintenance System ©1995 ECRI. (Note: Due to dust and moisture. Check the absorber-elevating mechanism and clamps for proper operation. connect a breathing hose from the patient inspiration valve to the patient expiration valve of the absorber. The oxygen flow rate should be less than 150 mL/min above the leak measured in Item 2. For anesthesia systems with minimum oxygen flow. Close the APL valve. Remove any dust from the bottom of the absorber. It should take at least 30 sec for the pressure to drop from 50 to 30 cm H2O. Leave the setup as in Item 2. and verify that both gauges have the same readings.8. with the APL valve closed or in its minimum-flow condition. the gauge reading should be near ambient.5 and 0 cm H2O. Partially open the APL valve. indicated on both the test gauge or meter and the pressure gauge in the breathing system. Turn on the minimum flow of oxygen. Remove the canister from its holder. Now reduce the flow rate to 30 mL/min. some of these valves on older units will not turn and might break when force is applied. repeat the pressurization. 2. With the scavenging system at the minimum vacuum.) The pressure should drop immediately. and restore the normal pressure-limiting valve setting. Alternatively.9 Scavenging System.6. without inverting it. and that it then opens. follow the manufacturer’s recommendations for testing for low-pressure leaks. The pressure gauge or meter should read at least 30 cm H2O. Less time indicates a leak in the breathing system that should be corrected. In its place. If the pressure falls.7 to identify whether the breathing system is the major source of the leak. replacing it with the breathing bag. A reading of less than 30 indicates an unacceptable leak that should be corrected. connect a stopper with a fitting for a sphygmomanometer squeeze bulb.Inspection and Preventive Maintenance System gas outlet and pressurize the outlet section. . If the pressure does not drop. and replace it with a -10 to +80 cm H2O pressure gauge or meter. the pressure gauge or meter reading should be between -0. including vaporizers. Open the moisture-relief valve. Remove the manual reservoir bag. Insert the pressure gauge or meter between the APL valve or exhaust port and the scavenging system intake. which is acceptable. Pressurize the system with oxygen to a steady 30 cm H2O. If the APL valve is not the bleeding type. clean the valve of dried soda lime.7 Breathing System. Remove the reservoir bag. Occlude the outlet to the manual reservoir bag and close the APL valve. squeeze the bag and verify that the valve holds pressure until a specific level is exceeded. Other valves. may operate in a completely different manner and at a higher pressure and should be tested according to the manufacturer’s specified procedure. Check the carbon dioxide absorber housing for cracks or broken edges in the glass or plastic canister and in the check valve domes. Proceed to Item 2. and set a 10 L/min oxygen flow rate. Check that the opening pressure is adjustable from approximately 1 to at least 30 cm H2O. Connect the -10 to +80 cm H2O pressure gauge or meter to a piece of breathing system tubing that is connected to the inspiratory and expiratory valve outlets.8 APL Valve. to approximately 30 cm H2O by opening the oxygen flow control valve slightly (this is about three times the average working pressure).7 but remove the pressure gauge or meter. such as the Georgia and Drager valves. Close the pressure-limiting valve. and open the relief valve again.

Level the flowmeter. Examine flowmeters for signs of damage or abuse (e. return all flowmeters to zero position. Inspection and Preventive Maintenance System ©1995 ECRI. 3. For each flowmeter. observe the float motion as the associated valve is turned. set the flow rates at a high and low setting for each flowmeter that lies within the range of the calibrated flowmeter.g. Record the readings of both the machine and the calibrated flowmeters. Manually ventilate the test lung with the PEEP valve set to deliver 0 cm H2O water pressure. clean all compressed-gas filters.. inverted. At maximum flow. Turn off the flow of nitrous oxide. the float should still be visible at the top of the flow tube.1 Clean any excess leak-detection solution from the exterior and interior of the unit. The pressure should remain at less than 10 cm H2O.g. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. condensation. For each gas in turn. 2. Close the valve to the anesthesia unit’s oxygen flowmeter. oxygen. The pressure in the breathing system at the end of exhalation should be within 1. 2. The end-exhalation pressure in the breathing system should be less than 1 cm H2O. condensation. The following procedure applies to each flowmeter on the anesthesia unit. helium. The following procedure applies to those systems that provide a minimum flow of oxygen or a minimum percent of oxygen. verify that at least the minimum percent of oxygen (stipulated by the manufacturer) is delivered as the flow of nitrous oxide is increased. and reconnect all tubing (e.12 PEEP Valve. internal nicks. Lubricate per the manufacturer’s specifications. carbon dioxide). set it to deliver 5 and 10 cm H2O water pressure. Connect one of the calibrated flowmeters to the common gas outlet with its discharge directed into the scavenging or other gas evacuation system. The readings on the unit’s flowmeters should agree with those on the calibrated flowmeters to within 10% of set values or the manufacturer’s specifications.4 4. Use the -10 to +80 cm H2O pressure gauge or meter to measure the airway pressure at the test lung. If the error is excessive.Anesthesia Units Repeat the last measurement with the APL valve fully open while occluding the vacuum hose and activating the flush valve for 5 sec. Preventive maintenance 3. The float should rise and fall freely as the flow is raised or lowered. Using an oxygen monitor.. if needed.1 to 1.10 Flowmeters. if needed. If other flowmeters are provided (e. check for damaged.. Set up the breathing system with a test lung. turn all vaporizers to off position. cracks. 3. Attach a Caution tag in a prominent position so the user is aware that control settings may have been changed.5 cm H2O of the set value. Replace compressed-gas filters and alarm batteries. and air). although this depends on the fresh gas flow and APL valve setting. or interchanged flowmeter tubes. make similar checks and enter data on the back of the form. Return all controls to pre-use settings. Repeat the tests with the second calibrated flowmeter and the second group of flow rates. nitrous oxide.10 (i. If the PEEP valve is calibrated. scratches.g. Before returning to use Depressurize external gas supply. main common gas outlet tubing). All Rights Reserved. 2. The flowmeter should read the minimum flow stipulated by the manufacturer (usually 100 to 250mL/min).0 L/min oxygen flowmeter to the common gas outlet. or damaged floats. Record the data on Line 2. Set the flow of oxygen to around 200 mL/min. Connect the 0. debris).11 Minimum Oxygen Flow and Percent.2 3.. 9 .e.

Patient data can be recorded and printed as either tabular data or waveforms.. thermistor-.. applies to adult and infant monitoring units or modules. pulse oximeters). and to troubleshoot equipment problems. low battery). hours hours * Minor interval applies only to units used for home care. High. critical care units. heart rate alarm without other ECG features) Risk Level: ECRI Recommended. Plymouth Meeting. Overview Our evaluations of infant apnea monitors have stressed that apnea monitoring is still an imperfect science. to distinguish true from false alarms. 009007 420-0595 A NONPROFIT AGENCY 5200 Butler Pike.g. heart rate) and equipment (power on/off. as well as impedance-. delivery rooms. When inspecting these monitors. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. some apnea monitors also include other monitoring capabilities (e. nurseries.g. ambulances Scope: Applies to apnea monitors. which display the patient’s breathing rate and alarm when previously selected high or low limits are exceeded. ventilatory effort monitors. An additional poster (Poster HD 625-290) and warning notice (Health Devices 1990 Apr. See the device’s operating manual and the Health Devices evaluations cited below for specific information. . ECG and blood pressure). 19:142-5) provide guidance for apnea monitors used in the home. depending on the amount and format of data and the parameters stored. Some apnea monitors have documentation capabilities that typically can record two or more channels of patient event data ranging from several hours to several months. apnea alarms and respiration monitors. which should be checked using the appropriate procedure/checklist unless the function is very limited (e. Hospital Assessment.. and airway-pressure-type monitors. which alarm if a patient stops breathing. be alert to indications of incorrect equipment usage and misapplication. PA 19462-1298.org . homes. Type Major Minor ECRI-Recommended Interval 12 months 3 months * Interval Used By Hospital months months Time Required . and respiration rate monitors. Confirm that users are aware of proper monitoring techniques and the monitor’s limitations. Recording [17-885] Impedance Pneumograph Monitors [12-621] Respiration Monitors [12-662] Also Called: Cardiorespiratory monitors.Procedure/Checklist 420-0595 Apnea Monitors Used For: Apnea Monitors [12-575] Apnea Monitors. in addition to making a qualitative and quantitative inspection of the monitor itself. capnometers.g. Recorded data are available in two categories: patient (respiratory rate. motion-. An ECRI poster (Poster HD 602-980) warned of the susceptibility of these monitors to artifact and provided succinct reminders and hints for clinical personnel. These data can be used to ensure that the monitor is being used properly. apnea detectors Commonly Used In: Pediatric departments. does not apply to other types of monitors with respiration monitoring functions (e.

make sure the memory contents have been successfully downloaded and documented. 23(7):309-10.g. Be sure that all fasteners are tight and that the mount is sturdy. formula). Automatic activation is triggered when an event occurs that exceeds preset monitor limits. all data from the selected channels are recorded for a specific duration. inspect the interior of the monitor for intrusion of fluids into electronic circuitry. Infant apnea monitors [Evaluation].. variable base impedance from 100 1. If there are signs of fluid spills. 16:385-7. and an apnea function. Some units overwrite the old data with more recent events. 21(10):342-79. but additional equipment may be required to supplement missing functions ECG simulator with variable rate may be required (may be part of the respiration simulator or may be a separate unit) Memory interface and documentation hardware and software (where applicable) Citations from Health Devices Infant apnea monitors [Evaluation]. the significance of each control and indicator.. Qualitative tests When performing IPM on apnea monitors with memory and documentation capabilities. 22(5-6):301-3. that necessary assembly hardware is present and tight. using the IPM checklist). Do not test the monitor while it is in use. At the end of the procedure. 1994 Jul. Apnea monitors should not be placed on top of incubators where they can be easily dislodged Test apparatus and supplies Leakage current meter or electrical safety analyzer Ground resistance ohmmeter Stopwatch or watch with a second hand Respiration simulator (needed for impedance-type monitors only) that includes controls to vary the respiration rate. Examine the exterior of the unit for cleanliness and general physical condition. If the monitor has memory and documentation capabilities. and the alarm capabilities. 1987 Dec. arrange to be notified when the monitor is available. 1980 Aug-Sep.1 to 1 Ω. The data stored in the memory can be managed one of three ways. 16:79-88. Procedure Before beginning an inspection. 1993 May-Jun. Infant home apnea monitors: Essential safety features and practices. If the unit is mounted on a stand or cart. and that there are no signs of spilled liquids or other serious abuse. 21(10):383. and some documentation monitors stop storing data when the memory is filled. 22(12):564-5. to 5. 19:142-5. variable respiration resistance change amplitude from 0. Infant home apnea monitors: Essential safety features and practices [Hazard update]. and duration of patient and equipment alarms and events should be recorded (e. Infant home apnea monitors [Evaluation update]. others keep the data that satisfy specific criteria based on the duration of the events. the memory contents should be compared to the log contents. If a substitute monitor is not available. All Rights Reserved. 1987 Mar-Apr. 9:247-83. 1987 Feb.Inspection and Preventive Maintenance System Activation of memory waveform recording can be automatic or continuous. be sure that you understand how to operate the equipment. ask the nursing staff whether the patient can be temporarily removed from the unit. type. 1990 Apr. Mount. 1992 Oct. Be sure that plastic housings are intact. 16:44-6. Also. 1993 Dec. carefully read this procedure and the manufacturer’s instruction and service manuals.g. Risk of electric shock from patient monitoring cables and electrode lead wires [Hazard]. check the mount’s condition. Alternatively. simulators with fewer capabilities may be used for inspection. 1. a log identifying the order. . 1993 Dec. Infant home apnea documentation monitors [Evaluation]. 1. Infant home apnea documentation monitors [Evaluation update].000 Ω.2 2 Inspection and Preventive Maintenance System ©1995 ECRI. determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. The monitor top should not be used as a storage area for other material (e.1 Chassis/Housing. It may be necessary for someone to watch the patient in the interim. 1992 Oct. Connection of electrode lead wires to line power [Hazard]. In the continuous mode. Air-Shields System V Model HRRM71-2 heart rate and respiration monitor [User Experience NetworkTM]. 22(12):598-601. Loose-lead alarms resulting from dried-out disposable electrodes [User Experience NetworkTM].

The lead-electrode connector should be of the type that cannot be inadvertently plugged into a 115 VAC outlet or power cord. Connect the patient cable to the monitor. be sure an adequate supply is on hand. if the damage is near one end. Inspect the cables (e. Where a control should operate against fixed-limit stops. as well as positive stopping.9 Inspection and Preventive Maintenance System ©1995 ECRI. Inspect the cord for signs of damage. and jiggle the sensor cable. Consult with the patient’s physician to determine correct settings. Check membrane switches for membrane damage (e. suspect damaged cables or weak contact with the electrodes.7 1.6 1. All Rights Reserved. Confirm that any necessary electrodes and/or transducers are on hand and check their physical condition. being careful not to disturb the sensor in such a way as to simulate a breath. if readily accessible. Inspect the physical condition of batteries and battery connectors. During the course of the inspection.17 Battery/Charger. Record the settings of those controls that should be returned to their original positions following the inspection. Verify that the insulation on thermistor sensors is intact. If any damage is suspected. a thermistor. or other sensor.g. If disposable electrodes are used. without the use of tape.) Circuit Breaker/Fuse. patient sensor. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors of each end to prevent rotation or other strain. Carefully examine sensor belts. check battery charger line cords. Check that air mattresses are free of leaks and that the tubing that connects the segments of the mattress to the manifold fits well. Strain Reliefs. for general condition. If damaged. including electrical cable connectors.5 1. intermittent contact can provide false indications.. check its value and type against that marked on the chassis. and ensure that a spare fuse is provided. Be sure to wire the new power cord or plug with the same polarity as the old one. Check operation of battery-operated power-loss alarms. pens). Attach a pair of electrodes to the patient cable and hold the RA and LA electrodes face to face. Keep spare tubing on hand to make necessary repairs. For monitors using belts. (See Health Devices 1993 May-Jun. and bright. check their positions. If the device has a switch-type circuit breaker.g. bands. bands. Cables. check for proper alignment. remote alarm) and their strain reliefs for general condition. insert an AC plug into each and check that it is held firmly. affix the cord to the unit so that it cannot be removed by the operator. If either breaths or lead faults are indicated. 1. If there are cracks or defects in the insulation. Before moving any controls and alarm limits. Be sure that they hold the cord securely. Attempt to wiggle the blades to determine that they are secure. connect the sensor to the monitor. and correct motion. and jiggle the leads. Examine the AC power plug for damage. Electrical contact pins or surfaces should be straight.g. turn the unit on at maximum sensitivity. turn on the monitor. A wall-supported shelf or bracket dedicated to the monitor is recommended. Shake the plug and listen for rattles that could indicate loose screws.4 AC Plug/Receptacles. If accessories are plugged and unplugged often. from fingernails. If the line cord is detachable (by the user). consider a full inspection of the receptacle. If the device is protected by an external fuse. If the device has electrical receptacles for accessories.10 Fittings/Connectors. open the plug and inspect it. The parents should receive additional training if required. 3 . clean. a gain control at maximum. If any appear inordinate (e. 1. Line Cord. check that it moves freely. 1. secure mounting. Observe the monitor for artifacts that would indicate a defective cable or connector. Examine the strain reliefs at both ends of the line cord.Apnea Monitors or obscure the view of an infant. either replace the entire cord or. Investigate questionable control settings on a home care monitor. 22[5-6]:301-3. if so 1.. alarm limits at the ends of their range). be sure to check that each control and switch performs its proper function. or pressure transducer) for intact insulation. or pads (magnetic. Also. capacitive. remove the sensor from service. Electrode leads and cables are often fragile and may lack adequate strain relief. Examine all controls and switches for physical condition. a mattress pad. consider the possibility of inappropriate clinical use or of incipient device failure. 1. 1.11 Electrodes/Transducers.13 Controls/Switches.. Examine all fittings and connectors. cut out the defective portion.

Quantitative tests 2. and off. Operate the device in all normal modes. 1. All Rights Reserved. If the device has an alarm-silence feature. If a bedside or central station monitor is grounded through system interconnections in addition to power line grounding and is only used in this configuration. Vary the base impedance and determine the resistance value at which the unit first indicates an electrode fault. Increase the rate to 100 bpm and verify that the sensitivity does not change abnormally. baseline. or multimeter with good resolution of fractional ohms. and instruction cards are present and legible. and visual displays on the unit and charger. as well as the operation of the volume control.24 CRT Display. When it is necessary to replace a battery. Operate the unit on battery power for several minutes to check that the battery is charged and can hold a charge.000 to 2. To verify that this indicator functions properly.5 Ω. Check that any associated interlocks function. Leakage Current. slope. 1. then resume the simulated respiration.21 Audible Signals.e. position. labels. Verify that the monitor detects each resistance change. Discrepancies between similar monitors or from previous readings greater than 25% suggest significant deterioration of the monitor and should be investigated. this reminds clinical personnel that the patient needs closer attention. This is usually in the range of 1. charge the battery. check the method of reset (i. verify that breaths are not detected when 2. Sensitivity. confirm the operation of all lights. This check is for impedance-type monitors only. With the monitor set at maximum sensitivity. to the extent possible.1 to 0. Verifying low grounding resistance is adequate. Connect the respiration simulator and. Most monitors will detect resistance changes of 0. label it with the date. if adjustable. resistance change of 1 Ω. If the device has an accessory outlet. confirm that it does. During the course of the inspection. verify its function. check its grounding to the main power cord. Verify that electrode gel. halt simulated respiration until the apnea alarm sounds. if so equipped. in fact. and breathing rate of 30 bpm (15 bpm for an adult monitor).1 Grounding Resistance. 1.3 Ω at maximum sensitivity.Inspection and Preventive Maintenance System equipped. Connect the monitor to the respiration simulator. Measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not ano- 4 Inspection and Preventive Maintenance System ©1995 ECRI. Check that the reset control functions.20 Alarms/Interlocks. 1. if used.2 dized) metal on the chassis with an ohmmeter. bow. If the unit is used with a remote alarm indicator. check it for focus. set it for a base impedance of 500 Ω.23 Accessories.3 Open Electrode Indicator. burn spots. 1. is available. Chassis leakage current to ground should not exceed 300 µA. Operate the device in such a way as to activate each audible and visual alarm. Verify that the display amplitude increases as the impedance change setting of the simulator is increased. Decrease the resistance change on the simulator and record the minimum value for which breaths are reliably detected. 1. 2.19 User Calibration. Check that all necessary placards. Operate the device to activate any audible signals. then do not disconnect the monitor from the system to measure leakage current during routine inspections. Confirm that the calibration or test function operates. set it at maximum sensitivity. Confirm appropriate volume. standby. manual or automatic) against the manufacturer’s specifications. electrical safety analyzer. . Check the condition of the battery charger and. If the unit includes a display of respiration waveform.22 Labeling. Be sure that all segments of a digital display function. We recommend a maximum of 0. If the monitor has a manual sensitivity control.18 Indicators/Displays. Impedance-type monitors. Some apnea alarms that reset automatically when breathing resumes have a separate indication that an apneic episode has occurred. indicators. including on. 2. if so equipped.4 2.. 1. and 60 Hz interference or other noise.000 Ω. Measure chassis leakage current with the grounding conductor of plug-connected equipment temporarily opened.

test these as part of this procedure. For home use. Also. Check the apnea alarm delay by stopping simulated respirations. Using the respiration simulator. Measured times should agree with indicated times within 20%. 2. If possible.12 Rate Alarm Accuracy. Set the low and high respiration rate alarms at 22 and 78 bpm.5 ECG Features. including remote alarm if needed. respectively. monitors must also include a power-loss alarm (nonbattery-operated unit) and a remote alarm.) Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. and verify the operation of the high-rate alarm. If the ratemeter is digital. if so equipped. a “1” and “0” in the hundreds place is all that is needed there. If the control is continuously variable. Testing is similar to that described in Item 2.2 Before returning to use Remind clinical personnel of the limitations of the monitor and be sure that they understand the operating principles of that particular unit. 2. Time the delay between cessation of respiration and apnea alarm. check both shortest and longest times. and observe that the sensitivity varies with the control setting. If the unit includes ECG and heart rate monitoring. Only qualitative tests of sensitivity can be made with other types of sensors. Inspection and Preventive Maintenance System ©1995 ECRI. medium. set the apnea delay to at least 10 sec. A display of “8” in the tens and units position will check all elements of a segmented or dot display. Next. Some simulators.Apnea Monitors the simulator is set to 0 bpm or turned off. (See Health Devices 1990 Apr. Read the ratemeter when it reaches equilibrium. record the actual sensitivity at high and low breathing rates (at low.4. in fact. and high sensitivity on manual units). Acceptance tests In addition to other considerations.1 Clean the exterior of the unit with a damp cloth. Confirm the absence of artifacts at maximum sensitivity. make sure that the audible alarm volume. Slow down the simulated respiration rate to about 20 bpm. if discrete times are available. check the instruction manual to determine whether this feature is present. If more extensive ECG tests are required. Some monitors include coincidence circuitry designed to compare breathing and heart rate signals or data and to reject detected breaths that may. 4.1 Sensitivity. and reset any alarms that may have been triggered during setup. since a hospital may own more than one type of apnea monitor. when turned off. is set so that it can be clearly heard. the unit must indicate whether it is operating on battery power or is being powered (and charged) from line power. perform the following tests. verify operation of coincidence circuitry during incoming inspection. Observe the ratemeter. make sure that the controls are set correctly for the patient application. if needed. simulate a rate of about 60 bpm. sensitivity will vary with the simulated respiration rate. 2. Also. Indicated rates should be accurate to within 10%. In some cases. Simulate breaths in the appropriate manner for each monitor. 3. be erroneously detected QRS complexes. If the monitor is being used at home. every apnea monitor must include a heartbeat detector (or other backup mechanism to the primary apnea detection function). All Rights Reserved. 19:142-5 for further information. Other types. Check all times. Some monitors have fixed alarm delays. Preventive maintenance 3.10 Apnea Alarm Delay Time. In addition. If the unit has limited ECG features — such as a heart rate alarm — but no additional ECG functions. then increase the simulated rate to 80 bpm or higher. record the maximum sensitivity at a base impedance of 100 Ω. activated when the indication falls below 22 bpm. reset any alarms. Coincidence Circuit. Check the alarm-silence function. however. check the rate display on respiration rate monitors at low rate (about 15 bpm for adult units and 30 bpm for infant units) and high rate (100 bpm). perform trace quality and additional testing as part of a separate ECG Monitors procedure. 5 . If battery-powered. may present a high base resistance to the monitor that can cause extraneous noise pickup. 4. Simulate a respiration rate of about 30 bpm. and verify that the low-rate alarm is 4. see ECG Monitors Procedure/Checklist 409. 2. vary the simulated rate to check for malfunctioning digits.11 Ratemeter Accuracy.

Surgical. Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . This energy leaves the laser tube through a partially reflecting mirror and is typically directed into a flexible optical fiber that transmits the laser energy to the tissue. The extent and frequency of inspection by hospital personnel should be coordinated with these outside services. Argon [16-941] Also Called: Argon lasers. These lasers must be meticulously maintained in order to ensure proper and safe operation. General-purpose argon surgical lasers have a laser tube containing an argon gas mixture that is caused to emit light energy by an electric field. emit blue-green visible light energy at 514 and 488 nm. Hospital assessment. Failure of an argon surgical laser can cause patient or staff injury.org . The fiber may be used with additional devices (e. PA 19462-1298. endoscopy laboratories. below 2 W).and high-power argon surgical lasers that are typically used for general surgery. which are typically low power (e. Argon surgical laser fibers are most often used in contact with or close to tissue to cause coagulation and vaporization.Procedure/Checklist 462-0595 Argon Surgical Lasers Used For: Lasers. Plymouth Meeting. gynecology. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. blue/green lasers. photocoagulator lasers Commonly Used In: Operating rooms. and can provide sufficient power output to coagulate and vaporize tissue. high-power ophthalmic lasers. High. through 230380 462-0595 A NONPROFIT AGENCY 5200 Butler Pike. Argon surgical lasers affect tissue by delivering blue-green visible light energy at a sufficient power density to cause vaporization and/or coagulation. surgical lasers. many of the tests listed herein can be used or modified for these other lasers Risk Level: ECRI-recommended. bronchopulmonary lasers. gastroenterology lasers.g. short procedure areas. or damage to the laser system. gastroenterology. .. This minimizes the need for frequent additional periodic testing. hours hours Overview Argon lasers are normally checked before each use by the laser’s power-on self-test and by user examination of the aiming beam and the delivery system to be used. The 488/514 nm argon energy is preferentially absorbed by pigmented tissue and hemoglobin and is typically absorbed within 3 mm of the tissue surface.. neurosurgery. however. does not apply to ophthalmic argon lasers. applies to low. ophthalmic operating rooms Scope: Applies to general-purpose argon surgical lasers that include contact and/or noncontact flexible fiberoptic delivery systems (either reusable or disposable). and ENT surgery procedures.g. Moving the fiber tip away from the tissue to lower the power density causes less tissue to be vaporized and coagulated. abrupt interruption of a surgical procedure. Manufacturers or outside service vendors often maintain lasers for hospitals. bronchopulmonary.

As a result. Test apparatus and supplies Leakage current meter or electrical safety analyzer Ground resistance ohmmeter New. Do not switch it to the operating mode until the procedure is about to begin and the laser and its delivery system are properly positioned. particularly when the internal interlock is overridden or in any other situation in which the energy does not diverge significantly over long distances. Under some circumstances. excess heat is generated in the laser cavity.. argon lasers can emit a single pulse or a train of pulses. requiring a cooling system. windows should be covered with nonreflective material to prevent transmission of laser energy to other areas. or firebrick Laser radiometer (power meter) Laser safety signs Laser safety eyewear specifically designed for use with argon surgical lasers and of sufficient optical density to protect the wearer’s eye from laser injury Vise with padded jaws or ring stand with padded clamp Pressure gauges and coolant system tee fitting Outlet test fixture (optional) Insulating gloves. Area security and use of personnel protective devices and practices should be consistent with hospitalwide laser safety procedures and/or should be approved by the laser safety committee. 20(78):239-316. 1991 Jul-Aug. In addition. especially during procedures of recognized risk. it should be in the standby/disabled mode. . to summon help in case of an accident. alcohol). and do not aim the laser across a path that a person might normally use as a thoroughfare. kneeling. Wear appropriate laser safety eyewear at all times whenever the laser is in the Operating mode. When in use. and far greater care is required than with most devices. tongue depressors. and remove the laser operation key and store it in a controlled location. Target materials will ignite when exposed to high laser Citations from Health Devices Laser use and safety [Guidance article].g.e. Most argon lasers use water/air cooling systems that are self-contained. exercise great care whenever a laser beam is accessible. the beam may not diverge significantly. Remove from the working area or cover with flame-resistant opaque material all reflective surfaces likely to be contacted by the laser beam. even a full room length or more away from the laser (and can harm tissue or burn material even at this distance). Personnel who inspect or service lasers should receive special training 2 Inspection and Preventive Maintenance System ©1995 ECRI. argon lasers are inefficient in converting electrical energy into laser energy. at minimum. post doors to the room with appropriate laser safety signs stating that the laser is in use and that it is unsafe to enter the room without authorization by the service person performing the procedure. 1″ or more wide. from the manufacturer or from a qualified alternative training source. about 3″ to 4″ long. unused fiber delivery system Black Delrin block 1⁄2″ or more thick. 21(9):306-10. Furthermore. Do not use the laser in the presence of flammable anesthetics or other volatile substances or materials (e. use a firebrick or other nonflammable material behind the target material (e. energy can be emitted from the surgeon’s headpiece through a handheld lens and focused on the patient’s retina).. sitting. All Rights Reserved.Inspection and Preventive Maintenance System an endoscope). Surgical lasers [Evaluation]. If the procedure must be interrupted. Do not perform these procedures when a patient is present or clinical staff is working.g. WARNING: Do not stare directly into the aiming system beam or the therapeutic laser beam. disconnect the laser from line voltage.. Like most lasers.g. These attachments may focus the energy into a small spot size at a known working distance and/or a specific beam direction to accomplish special tasks (e. with a headpiece and lens. In addition. or standing). and/or with a laser handpiece or a laser micromanipulator (used to interface the laser with the surgical microscope). 1992 Sep. The laser should remain in the off position when not in use. A second person should be present. even when wearing laser safety eyewear. Laser energy can cause serious injury. or in oxygen-rich atmospheres. Avoid placing the laser beam path at eye level (i. or connected to a water supply and drain. high voltage (optional) Grounding strap (optional) Calibrated flowmeter Special precautions Inspecting and maintaining lasers is a dangerous as well as necessary process. because of the serious risk of explosion and fire. black Delrin) when the laser is to be activated. Therefore.. connected to a freestanding chiller system. Whenever possible.

carefully read this procedure and the manufacturer’s operator instructions and service manual. A CO2 fire extinguisher should be readily available. Examine the exterior of the unit for cleanliness and general physical condition. Qualitative tests 1. and being used. that assembly hardware is present and tight. If the device has a switch-type circuit breaker. Consult the manufacturer’s recommended procedures for servicing high-voltage laser circuits.g.2 Mounts/Holders. Be sure to wire a new power cord or plug with the correct polarity. Similarly. Wiggle the blades to determine whether they are secure. or insulate high voltages carries the appropriate insulation rating (e. and ensure that they have been turned off after the last use.g.6 1. 3 . use short durations when practical. Be sure that they grip the cord securely..1) before any other test that requires operation of the laser. All Rights Reserved. check that it moves freely. Examine the strain reliefs at both ends of the line cord. Line Cords. If a cord is damaged. perform the Grounding Resistance test (Item 2. starch. Be sure to leave the shutter in the proper position for normal operation. which can be lethal. cut out the defective portion. Inspect line cords for signs of damage. or. Some surgical lasers use high voltages (e. use a redundant ground strap if you must enter the laser cabinet. that any retractable parts slide easily and lock in place if so constructed.1 Chassis/Housing.4 Procedure Before beginning the inspection. Ensure that equipment intended to be used to measure. Shake the plug. Report any laser accident immediately to the laser safety officer or equivalent. above 20 kV). Capacitors may store charges long after the device has been disconnected from line voltage. If damage is suspected. and inform users of the importance of storing the key in a controlled location.7 Inspection and Preventive Maintenance System ©1995 ECRI. Where possible. be sure that you understand how to operate the equipment. Verify that the key has not been left in the laser. and use insulated gloves for those procedures in which contact with a high-voltage source is possible (and the gloves are not otherwise contraindicated). check mounts or holders for other devices (e. Shutters.) Examine any external gas tanks that may be in use with the laser. replace the entire cord. and avoid contact with any portion of the high-voltage circuit until you are certain that the charge has been drained. Also. preferably. and listen for rattles that could indicate loose screws. Verify that the mounting apparatus is secure and that all hardware is firmly in place. footswitches). perform tests with the unit turned off..5 1. check its value and type against what is marked on the chassis or noted in the instruction 1. 1. ensure that they operate smoothly and correctly. When possible. WARNING: Do not use an anesthesia or other similar bag that may have a mold-release agent (e.. a good ground must be present. and precautions needed to ensure safety and avoid equipment damage. 20 kV). Because of the presence of high voltage. in good working order. If manual shutters for the aiming system or the therapeutic lasers are accessible.3 Casters/Brakes. 1.g. Circuit Breakers/Fuses. Verify that the casters roll and swivel freely. examine the condition of the mount. (Remove it if it has been. 1. AC Plug/Receptacle. if the damage is near one end. 1.g. determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Examine the AC power plug for damage. disconnect the laser from line voltage before entering the laser cabinet. Strain Reliefs. external power meters.. open the plug and inspect it. the significance of each control and indicator. and that there are no obvious signs of water or oil leakage. If the device is mounted on a stand or a cart. Be sure that mounts or holders intended to secure the fiber to the fiber support (to protect the fiber when in use) are present. If the device is protected by an external fuse(s). drain. Check that the mounts securely contain any gas cylinders that may be in use. talc) on its inside surface because the agent could contaminate the gas recirculation system of the laser and ultimately contaminate a patient wound during a subsequent procedure. Be sure that all housings are intact and properly aligned. that there are no signs of spilled liquids or other evidence of abuse. In such instances.Argon Surgical Lasers energies. General. as well as to the hospital risk manager. Check the operation of brakes and swivel locks.

secure mounting. verify the operation of both. and that they are secured adequately to any connectors. in this case. During the course of the inspection. Check the condition of all cooling-system hoses and any other hoses or tubing the laser may have (e. or surgical instruments).g. clean. be sure that each control and switch works properly. correct motion. Some footswitches include two internal switches. and. using 1. from fingernails. consider the possibility of inappropriate use or of incipient device failure. check and record their positions. pens. and is in use. gas. secure mounting. All Rights Reserved. If any position appears inordinate. Cables. fiber). Ensure that a spare is provided or readily available. Check that the internal switch is operating and that the footswitch does not stick in the on position. Measuring the pressure drop across a liquid filter can be helpful in determining whether the filter should be replaced. check for proper alignment as well as positive stopping.. A laser that connects to a central piped medical gas system or to a freestanding medical gas system should have the matching DISS or quick-connect fitting for the gas that it is to be used with.. notify users to avoid using tape and sharp instruments. trail on the floor. If the remote control is attached by cable to the laser. Where a control should operate against fixed-limit stops.. Footswitches for lasers include an internal switch that activates according to the depth of pedal depression. and that there are no signs of spilled liquids or other serious abuse.9 1. Flex the cable at the entry to the switch. and electrical fittings and connectors for general physical condition. even through a shoe. Be sure that no pins are missing from yokes and that the keying and indexing of connectors for each gas to be used is correct. If a control has fixed-limit stops.12 Filters. 4 Inspection and Preventive Maintenance System ©1995 ECRI. Ensure that any mechanism to close off the laser aperture (fiber port) is clean. Examine the exterior of the control for cleanliness and general physical condition. drain. Examine cables carefully to detect breaks in insulation and to ensure that they are gripped securely in the connectors at each end to prevent strain on the cable. and most require special filtration. Inspect all cables and their channels or strain reliefs for general physical condition. check to be sure that the laser activates consistently when the footswitch is depressed and that the fiber-coolant system operates properly when the fiber-coolant switch is activated and deactivated. that they have not become cracked and do not show other signs of significant abuse. and indicate this in the preventive maintenance section of the inspection form.10 Fittings/Connectors. and correct motion. Some footswitches also include a switch to operate the liquid.Inspection and Preventive Maintenance System service manual. Examine all optical (e. During the procedure.g. 1. 1.g. operates smoothly. Gas and liquid fittings should be tight and should not leak. Check the condition of all liquid and air filters. Examine all controls and switches for general physical condition. Check that they are of the correct type. Footswitch.. Clean or replace air filters that are obviously dirty. If external gas tanks or wall-supply outlets can be used. Examine all controls and switches for physical condition.or gas-cooling system. General. replace if the pressure drop is >5 psi). kink. or be caught in moving parts. gas). Check membrane switches for tape residue and for membrane damage (e. Check to be sure that this switch operates reliably.13 Controls/Switches. .8 Tubes/Hoses. that assembly hardware is present and tight. Before moving any controls. Remote. It is usually possible to feel the vibration caused by closure of the switch. If you find such evidence. Verify that suitable unique connectors are supplied so that adapters are not required. and intended range of settings. Electrical contacts should be straight. Some argon surgical lasers require deionized water. gas-specific connectors should be present. Clean or replace filters according to the manufacturer’s recommendations (e. ensure that the cable and any connectors are in good condition. including evidence of spilled liquids. liquid. Be sure that housings are intact. that they are connected correctly and positioned so that they will not leak. and bright. Examine the footswitch for general physical condition. 1. be sure to check that each control and switch performs properly.g. There should be no visible dirt or residue in the optical path of the laser aperture. check for proper alignment as well as positive stopping. During the inspection.

Verify that this feature is functioning by using the manufacturer’s recommended calibration procedure to test one delivery system (e.. If no self-check feature is present. If a feature to manually reset this information is available.. meters.. 1. When it is necessary to replace a battery. 5 . 1. be sure to test only those alarms that will not cause damage to the laser or present an unnecessary risk of laser beam exposure to the user or bystanders. Ensure that user prompts occur in the proper sequence.. If a door or window interlock is used. and visual displays on the unit and remote control.g. check for internal wire breaks that cause intermittent operation. 1. coolant) levels. label it with the date.) If the laser is equipped with an emergency “kill” switch. Check for proper operation.g. or it may require the user to do this manually. operate the laser in a manner that will activate each audible and visual alarm.18 Indicators/Displays. Inspect the physical condition of batteries and battery connectors. Some argon surgical lasers include a user-accessible calibration port or power meter that allows output calibration and/or testing of the laser fiber. displays) is indicated on both control panels during laser operation.17 Battery. test this feature to be sure that it deactivates the laser and that the laser will subsequently restart. pulse or accumulated energy counter).g. and verify that it is correct. Check all fluid (e. verify that the same information (e.g. verify proper operation of all lights. Refill or change the fluid according to the manufacturer’s recommendations. Ensure that all segments of a digital display function. check or replace the battery (periodic prophylactic battery replacement is often preferred to risking battery failure during use).15 Motors/Pumps/Fans/Compressors. Based on the measurement from the calibration power meter.g. If display screens or digital displays are provided for user prompts or for viewing accumulated information (e. fiber. undamaged sheath) fiber or handpiece should be used for this test. >85% transmissibility. ensure that each display provides the 1. Operate the device to activate any audible signals (e.21 information expected. note this in the preventive maintenance section of the form. if present. All Rights Reserved. 1. Store some sample information. and verify that all visual and audible alarms activate according to the manufacturer’s documentation. Be sure to check the interlocks in all locations where the laser is used. Confirm that strain reliefs are secure. the function of the interlocks can be checked using an ohmmeter.Argon Surgical Lasers an ohmmeter. gauges.) After deactivating the laser and reclosing the door or window. laser emission. and note this in the preventive maintenance section of the inspection form. Examine the male and female connectors for attaching the footswitch to the laser cabinet to be sure that no pins are bent and that no other damage is present. Ensure that the connector secures acceptably to the laser cabinet. During the course of the inspection.g. filters are oriented for proper flow. if present. Audible Signals.. drain hoses are positioned in a sink or drain).. This feature is provided because transmission of laser energy through a fiber may change as a result of fiber use. setting change).16 Fluid Levels. settings. A good-quality (e.20 Alarms/Interlocks. ensure that it works. Note any error messages displayed during the power-on self-test. 1. If primary and remote-control indicators and displays can be used at the same time or if control can be switched from one to the other during the course of a procedure. indicators. Operate the device in a manner that will activate the self-check feature. (Do not disassemble major parts of the laser to test internal interlocks. if readily accessible. and verify Inspection and Preventive Maintenance System ©1995 ECRI. If an external water supply is in use. ensure that the water pressure is properly regulated and at the appropriate pressure and that the supply and drain system is properly configured (e. ensure that it deactivates the laser properly. check to be sure that the laser will restart. the laser may automatically recalibrate itself and/or adjust displays so that the power indicated to be delivered to the patient will be correct. 1. (For some lasers. handpiece) that the manufacturer indicates can be acceptably calibrated using these procedures. If a remote control or display is battery powered. If lubrication is required.g. Check the physical condition and proper operation of these components.19 Laser Delivery System Calibration..

with no halo. verify that the spot size changes as expected and still remains uniform. when assembled. (Do not remove other parts that are press-fit or attached by screws. Be sure to handle it by the main body. labels.24 Aiming Beam.g.Inspection and Preventive Maintenance System that the signal can be heard in the environment in which the laser will be used. 1. The fiber should be repaired and/or cleaned according to the manufacturer’s recommendations. For the test fiber or before each use. notify the person(s) responsible for fiber repair. and do not touch the reflecting lenses in the body. For handpieces that provide adjustable spot sizes.22 Labeling. and firmly attached. many of the accessories are sterile and would require resterilization before use.g. Handpieces. All Rights Reserved. Examine each objective lens to ensure that it is intact and clean. . Fibers. Activate the aiming beam (without the therapeutic beam). Examine the joystick to ensure that it is firmly attached and that it freely moves the reflecting lens.. In addition. or snap-rings. Consult the manufacturer’s recommendations for the procedures and cleaning agents to use to clean lenses. Connect the micromanipulator to the microscope to check for a secure connection. Check to see that an instruction manual is kept with the laser or is readily available. Checking all fibers or accessories during a single inspection and preventive maintenance procedure is unnecessary as long as accessories are routinely checked by the person(s) responsible for laser setup and operation... Examine the microscope micromanipulator for cleanliness and general physical condition. lenses) for cleanliness and general physical condition. Examine each handpiece component (e. laser gas tubing channels) is present. If a fiber appears to be dirty or damaged. Ensure that the mechanisms used to connect the handpiece(s) to the fiber are in good working order and that they reliably secure each handpiece to the fiber. remove it from service. 6 Inspection and Preventive Maintenance System ©1995 ECRI. in good condition. Be sure that all hardware (e. and verify that it produces a round. Set up reusable accessories with the laser to ensure compatibility and proper functioning. Check that all placards. examine the connector. Microscope micromanipulator.g. Consult the manufacturer’s recommendations for the procedures and cleaning agents to use to clean reflecting lenses. If a zoom focus feature is present. are secure. Verify operation of safety filters in the microscope and endoscope delivery systems. making the laser potentially unavailable. Consult the manufacturer’s recommendations for the procedures and cleaning agents to use to clean the objective lenses. cable.23 Accessories. Examine the distal end of fibers to ensure that any connecting mechanisms (e. Inspect the mechanism used to attach the micromanipulator to the microscope to ensure that all parts are present and that it is in good working order. Be sure to check with the person responsible for scheduling the use of the laser before beginning the procedure. Do not touch the lens surface. and tip of each fiber that may be used. Argon lasers typically use an attenuated therapeutic beam as the aiming beam. Carefully insert each lens into the micromanipulator. as well as the fiber support. body. General. be sure not to touch the lens surface. tips. If a fiber is reusable. Safety filters. Ensure that the reflecting lenses are intact and clean. be sure that it turns easily and does not slip. Examine individually only those components that are intended for removal during normal use and storage. bolts. Ensure that major subcomponents of the handpiece. do not hold it by the joystick. 1. Ensure that the connector properly seats into the laser aperture of the laser cabinet. Verify fiber performance. ensure that it is firmly attached and properly oriented. handle lenses by the edges only.) If lenses are detachable. Inspect micromanipulators provided by both the laser manufacturer and the laser accessory manufacturer. threads) are in proper working order. 1. and instruction cards noted during acceptance testing are present and legible. Verify that all necessary accessories are available and in good physical condition. and ensure that it fits snugly. for cleanliness and general physical condition. uniformly bright spot. If a finger rest is present.

7 . Adjust the exposure setting in increments of 0.5 Footswitch Exposure Control. There should be no visible dirt or residue in the optical path of the laser aperture. ensure proper operation by allowing it to control the gas supply into and out of a sealed plastic bag.5 Ω. use the following less preferable alternative. If you are using such a power meter. if the laser power meter does not measure pulse duration.1 Grounding Resistance. Some laser power meters can react quickly enough to be used to test this feature of the laser. However. or micromanipulator attached. Carefully move the Delrin to expose a clean area. WARNING: Do not use an anesthesia or other similar bag that may have a mold-release agent (e. If the number or duration between repeat pulses is adjustable. or micromanipulator with the aiming system focused on the black Delrin or a tongue depressor. WARNING: Do not reverse power conductors for this or any other test. Remove and inspect the protective window (e.g. ensure that the regulator and the gauge operate as expected. WARNING: Make this inspection with the laser powered off. and have developed a series of burns. All Rights Reserved. It should be clean and undamaged. If the power meter can react to pulse duration (this is the preferred circumstance). Examine any gas regulators for cleanliness and general physical condition. 2. With the laser set to about 10 W and the exposure set at a minimum duration. Where it is greater than 300 µA. and maximum repeat pulse settings. If the unit includes a repeat pulse feature. Compare the burns to verify that progressively larger burns occurred as the exposure duration increased. grounding is not required. test that setting changes made throughout the range result in the expected performance.3 Exposure Duration. talc) on its inside surface because the agent could contaminate the gas recirculation system of the laser and ultimately contaminate a patient wound during a subsequent procedure. Verify that the correct gas is attached to each regulator. Ensure that the gauges on the regulators are not broken. Use an ohmmeter. 2. accessory outlet. and activate the laser at each setting. Be extremely careful to keep hands out of the laser beam path.2 Inspection and Preventive Maintenance System ©1995 ECRI. handpiece. if adjustable. 2. activate the laser and create a burn.4 Repeat Pulse. Set the laser to about 10 W and a 0. blast shield) behind the laser aperture. except continuous. ensure that appropriate grounding is present. Be sure that a key or wrench to facilitate changing the gas supply is with the unit or readily available. which repeats the pulse at a fixed or adjustable rate. During the procedure. We recommend a maximum of 0. measure the leakage current between the chassis and ground with the unit grounded and ungrounded. test the laser at each setting.26 Gas Regulators. starch. activate the unit. If the laser includes a gas recirculation system. (If the footswitch is of low voltage. Improper attachment of conductors may damage the laser.Argon Surgical Lasers 1.1 sec or the next longest duration. and verify that the repeat pulse feature operates as expected by moving the Delrin or the colored tongue depressor slightly between each pulse. replace if needed.1 sec exposure duration with the fiber. and re- 2. handpiece. If proper operation is questionable. or multimeter with good resolution of fractional ohms to measure and record the resistance between the grounding pin on the power cord and exposed (unpainted and not anodized) metal on the chassis. maintaining the same distance. The leakage current 2. If your laser power meter cannot be used for this test. on the chassis should not exceed 300 µA. Place and secure the laser fiber. test this feature with the laser set at the minimum. use the following alternative test method. test the laser to be sure that the correct power is repeatedly delivered over the correct time period. ground pins. Set the output time for about 5 sec.25 Laser Aperture. Quantitative tests 2. consider using a calibrated flowmeter to measure actual gas flow. 1. Some laser power meters can measure pulse duration. Continue this process until you have tested all exposure settings.. median. and footswitch.. in no case should it exceed 500 µA.g. With the laser attached to a grounded powerdistribution system.) Leakage Current. electrical safety analyzer.

) Compare the reading with the power display of the laser. microscope lenses). a line cord. are functioning properly. blast shield. or after the last service procedure. If reverse-polarity leakage current measurements are made. Ensure that the branch circuits and the outlets for the laser are properly wired and rated for use with the laser. Also. do not switch conductor connections or wiring configurations for any tests.. Also test the ability of the laser to deliver laser energy as expected in all configurations and with all provided laser accessories.g.g. (Power meters use different time constants to acquire an acceptable reading. Secure the delivery system at the appropriate distance from the detector of the laser power meter to meet spot-size requirements specified in the instructions for the meter.. handpiece. If the laser includes a low-power (e. WARNING: Lasers may be damaged by switching between normal and reverse polarity while the device is on. Visit the area(s) in which the laser is to be used and ensure that laser signs. lasers powered by three-phase electrical systems may be damaged if proper electrical phase connections are not made initially and maintained thereafter. Preventive maintenance Verify that all daily preventive maintenance procedures recommended by the manufacturer are carried out. as may occur during transport. Clean accessible optical components (e. compressor or printer components as recommended by the manufacturer.. All Rights Reserved. 3. Do not conduct electrical leakage current tests with reversed-polarity wiring. Examine the receptacles at each location where the laser is to be used to ensure that the proper electrical configuration (e. In addition. If the laser beam is focused on the detector of such meters.g. Replace filters if needed. (Do not focus the beam to a small spot on the power meter. and window coverings are available and being used and that safety interlocks for doors or windows. and maximum output. the measured and displayed values should all be within 10% of one another.g. threshold). Examine the unit and note the presence. if present. pump. Casters/Mounts/Holders. if necessary. including leakage current measurement. 2.4 4.3 Calibrate/adjust any components (e. . 3..10 Power Output. 10% of full scale). 4. fiber. 4. Ensure that all hoses and tubes are tight. Lubricate any motor. 3. eyewear. Ensure that the assembly is stable and that the unit will not tip over when pushed or when a caster is jammed on an obstacle (e... 50% of full scale).1 Areas of Use. Labeling information is typically found in the laser’s operator manual. In addition. proper 4. and content of all labels.. With the laser set at low (e. test it in a similar fashion with a power meter of appropriate resolution in the low-power range. Acceptance Testing Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. fan. printer) according to the manufacturer recommendations. Some power meters require that the unfocused or a defocused laser beam be projected into the power meter to cover the majority of the absorber surface.g. location. exercise great care if the interlocks are to be defeated. turn off the unit being tested before switching polarity. micromanipulator).4 3. compare the reading obtained with the reading taken on incoming acceptance testing.g. Electrical Wiring Configuration. perform the following tests.1 Clean the exterior.. using techniques and cleaning solutions recommended by the manufacturer. activate the laser for a sufficient period to acquire acceptable readings. at the last preventive maintenance procedure. ensure that it has nonslip legs or supports. Thus.3 4. Because of the heightened risk associated with an unfocused. medium (e. nondiverging laser beam. If the device is designed to rest on a shelf.Inspection and Preventive Maintenance System lease the footswitch after about 1 sec.2 8 Inspection and Preventive Maintenance System ©1995 ECRI. mW) feature.g. Only appropriately trained personnel should attempt laser adjustments.) WARNING: Accessing the unfocused laser beam may require defeating internal interlocks.g. and you must know and meticulously follow them.2 3. the meter may be damaged. Verify that the beam turns off when the footswitch is released. and perform the manufacturer’s recommended user calibration procedure. Select one delivery system (e. Check all fluid levels and supplement or replace fluids if needed. Labeling.

5 AC Plug.7 Before returning to use Be sure to return controls to their starting position. Note the fiber transmission for each delivery system tested if this information is provided by the laser.10). Verify that the plug is acceptable for use with the maximum current and voltage specifications for operating the laser. If the unit includes a Repeat Pulse feature. Use the manufacturer’s recommended calibration procedure to test each new reusable delivery system (e.Argon Surgical Lasers neutral and ground connections. medium. 9 . Verify proper wiring and connect the laser to each receptacle and confirm that the laser operates properly. (Consult National Electrical Manufacturers Association [NEMA] configurations for general-purpose nonlocking and locking connectors if in doubt. and high settings. test this feature as described in Item 2.g.9 Laser Delivery System Calibration. and place a Caution tag in a prominent position so that the next user will be careful to verify control settings. test the power output accuracy at several low. Or. you can calculate it using the following formula: % Transmission = Delivered power × 100% Power entering the fiber 4.) Pulse Duration.6 Delivery systems with less than the manufacturer-recommended transmission (typically >80%) should be returned to the manufacturer. 4. All Rights Reserved.4. setup. Verify that progressive increases in pulse duration throughout its range of adjustment result in progressively larger burns. handpiece) that the manufacturer indicates can be acceptably calibrated using these procedures. specifically confirming that motors are operating in the proper direction. Power Range. Using the technique described in the Power Output test (Item 2. proper phase rotation) has been installed. fiber. and function before using the unit. 4.8 Inspection and Preventive Maintenance System ©1995 ECRI. but over the full range of available settings.. 4. 4. Repeat Pulse.

Gomco (a registered trademark of Allied Healthcare Products. Overview Aspirators are among the most common types of clinical equipment in use within the hospital. Thoracic. to be used only when referring to that device) Commonly Used In: Ambulances.org . critical care units. 0 to 45 mm Hg Low-volume aspirators. cycling between atmosphere and 120 mm Hg. Breast [10-485] Also Called: Portable suction units. Thoracic [10-218] Aspirators. 0 mm Hg to >400 mm Hg Low-volume aspirators typically operate intermittently. for for Surgical Aspirators. Inc. does not apply to suction regulators (see Procedure/Checklist 459) Risk Level: ECRI Recommended. surgical. Medium for Surgical. Low-Volume [10-215] Aspirators. In hospitals with central vacuum systems. Low for Low-volume Aspirators and Breast Pumps.g. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. emergency and tracheal) are critical for life support. and Uterine Aspirators. for Breast Pumps. hours hours * Emergency and tracheal aspirators only. Plymouth Meeting. Hospital Assessment. Tracheal [10-219] Aspirators. pleural aspirators (thoracic aspirators). suction regulators are commonly used as an alternative to aspirators. 0 to 200 mm Hg Multipurpose high-vacuum aspirators. operating rooms. PA 19462-1298. Aspirators are categorized by their vacuum levels as follows: Thoracic aspirators. High for Emergency and Tracheal Aspirators. Surgical [10-217] Aspirators. Uterine [10-222] Pumps. Emergency [15-016] Aspirators. tracheal aspirators also found on “code carts” and low-volume (or intermittent) aspirators frequently used in medical-surgical units Scope: Applies to virtually all electric-powered portable and mobile suction sources.Procedure/Checklist 433-0595 Aspirators Used For: Aspirators [10-208] Aspirators.. tors. 009008 433-0595 A NONPROFIT AGENCY 5200 Butler Pike. for Uterine Aspirators Type Major Minor ECRI-Recommended Interval 12 months 6 months* Interval Used By Hospital months months Time Required . for Tracheal Aspirators. some (e. emergency departments. gastric aspirators (low-volume aspirators). and tracheal (high-vacuum) aspirators. for Emergency Aspirators. . 0 to 150 mm Hg Emergency. for Thoracic AspiraLow-volume Aspirators.

Inspection and Preventive Maintenance System
Suction, or aspiration, is used to remove obstructing secretions, blood, or vomitus from a patient’s airway to keep air passages to the lungs open and to allow spontaneous or mechanical ventilation. Suctioning can be either oropharyngeal (to prepare for emergency intubation or to remove secretions from the upper airway above the glottis) or tracheal (to remove obstructions from the trachea of an intubated patient). In emergency medical services (EMS) use (in ambulances and in the field), portable aspirators are usually used for oropharyngeal suctioning. However, more and more emergency medical technicians (EMTs) and paramedics are being trained in intubation and advanced airway maintenance in which, after suctioning, a rescuer intubates the clear airway with an endotracheal tube. Since the cuff of that tube interferes with the natural evacuation of mucus, tracheal aspiration is also used to remove obstructions after intubation. Tracheal aspiration may also be required during interhospital (nonemergency) transport of intubated patients. Portable emergency aspirators are used by EMS personnel outside the hospital and on bedside stands in the hospital. They draw power for charging their batteries from an AC line, an ambulance DC-to-AC inverter, or the ambulance’s 12 VDC electrical system. Data gathered during ECRI surveys of hospitals indicate that even serious performance degradation in suction apparatus is often not apparent to clinical personnel. This emphasizes the need for periodic inspection. Critical performance parameters for suction apparatus are vacuum, vacuum rise, and, in some types, free airflow. A supply of clean catheters, suction tips, and tubing should be stored near the aspirator or kept readily available. Flowmeter, 10 to 50 L/min, ±5% Tubing and adapters for connecting vacuum gauge or pressure meter and flowmeter (a T fitting is needed) Disposable suction canister (if applicable)

Special precautions
Aspirators may be contaminated with contagious microorganisms from contaminated aspirant. Keep your face away from the exhaust port of the unit. Never place your mouth on any part of the regulator to blow or suck as a qualitative test of operation or to blow dirt out of a part. Wash hands thoroughly after inspection, especially if any accessories were disassembled. When it is necessary to disassemble an aspirator for repair, wear latex gloves, wrap cellophane or another nonpermeable barrier around the handles of all tools, and work on a surface that can be easily disinfected. Dispose of gloves and tool handle wrappings as infectious waste.

Procedure
Before beginning an inspection, carefully read this procedure and the manufacturer’s instruction and service manuals; be sure that you understand how to operate the equipment and the significance of each control and indicator. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. It is vital to identify the type and/or application of the aspirator to be inspected in order to define the performance criteria for the inspection. This is often difficult because most devices bear only a model or catalog number. Obtain this information from the manufacturer’s literature, previous inspection forms, or clinical personnel. Once the type of aspirator has been identified or when new units are purchased, enter this information on the equipment control or inventory record so that it can be determined quickly from the control number on the device in future inspections.

Citations from Health Devices
Suction canisters [Evaluation], 1983 Apr; 12:127-49. Portable emergency aspirators [Evaluation], 1991 Feb; 20:55-72. Should vacuum pump effluent be treated? [User Experience NetworkTM], 1994 Jul; 23:310.

1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that housings are intact, that all assembly hardware is present and tight, and that there are no signs of spilled liquids or other abuse. Mount. If the device is mounted on a stand or cart, examine the condition of the mount. Casters/Brakes. If the device moves on casters, check their condition. Look for accumulations of

Test apparatus and supplies
Ground resistance ohmmeter with resolution of 0.1 Ω Leakage current meter or electrical safety analyzer Stopwatch or watch with a second hand Vacuum gauge, 0 to 760 mm Hg, ±3%, or pressure meter with equivalent capabilities 1.3 1.2

2

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

Aspirators
lint and thread around the casters, and be sure that they both turn and swivel, as appropriate. Check the operation of brakes and swivel locks, if the unit is so equipped. 1.4 AC Plug. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the same polarity as the old one. Also check line cords of battery chargers. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the device has a switch-type circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare fuse is provided. Tubes/Hoses. Check the condition of all tubing and hoses. Be sure that they are not cracked, kinked, or dirty. Replace if needed and indicate this on Line 3.4 of the inspection form. If the device has an adjustable suction level, verify that the control is usable over the full range of vacuum settings. Although generally adjustable over a much wider range, tracheal aspirators should normally be operated at about 150 mm Hg during tracheal aspiration. Therefore, confirm that the unit is easily adjusted to this vacuum level (with the patient port occluded). 1.15 Motor/Pump. Confirm physical condition and proper operation. Lubricate if required, and note this on Line 3.2 of the form (but do not check 3.2 until you have completed all necessary lubrication). 1.17 Battery/Charger. Inspect the physical condition of batteries and battery connectors, if readily accessible. Check operation of battery-operated power-loss alarms, if so equipped. Operate the unit on battery power for several minutes to check that the battery is charged and can hold a charge. Check remaining battery capacity by activating the battery test function or measuring the output voltage. Check the condition of the battery charger and, to the extent possible, confirm that it does, in fact, charge the battery. When it is necessary to replace a battery, label it with the date. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, meters, gauges, and visual displays on the unit and charger if so equipped. Inspect the vacuum gauge for cracks and scale visibility. Make sure the indicator resets on zero without vacuum applied. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible. 1.23 Accessories. Verify that clean canisters, suction catheters, suction tips, and tubing are available. 1.24 Overflow Protection. To verify operation of the overflow protection on units so equipped, liquid must be aspirated into the collection bottle until the protective device is activated. (Observe while doing so that liquid will not be aspirated into the pump if the mechanism fails.) Place a bucket of water on the floor adjacent to the device being tested, connect a short length of hose to the patient fitting on the machine, and suction the water into the collection bottle. In units with relatively low flow rates (e.g., low-volume aspirators used for gastric suction), this test is expedited by pouring water directly into the collection bottle until it is nearly full, then reassembling the system and suctioning the remainder from the bucket. In

1.5

1.6

1.7

1.8

1.10 Fittings/Connectors. Examine all fittings and connectors for general condition. Replace if needed and indicate this on Line 3.4 of the form. 1.12 Filters. Check the condition of all liquid and pneumatic (air) filters. Replace if needed and indicate this on Line 3.4 of the form. 1.13 Controls/Switches. Before moving any controls, check their positions. If any of them appear inordinate, consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixedlimit stops, check for proper alignment, as well as for positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be sure to check that each control and switch performs its proper function.

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Inspection and Preventive Maintenance System
devices where overflow protection is provided by a hollow plastic ball (e.g., a table tennis ball), the ball will not function reliably if it is dented or cracked or has solids adhering to it. Conduct this test only on units with reusable suction canisters or overflow mechanisms. Do not test completely disposable systems. Aspirator Performance Values
These performance values represent best current opinion on clinical need and typical aspirator capability, not optimal design criteria. Discuss units unable to meet these criteria with clinical staff and schedule them for replacement or repair. Maximum Vacuum (mm Hg) >400 >40 >400 >40 >400 >400 >200 Rise Time (sec/mm Hg) <4/300 <30/30 <4/300 <4/30 <4/300 <3/300 <2/150 Maximum Free Flow (L/min) 25 NA 25 20 25 30 NA

Type Emergency Low Volume Surgical Thoracic Tracheal Uterine Breast Pump

2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 Ω. Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Record the maximum leakage current with the unit off and on. Leakage current should not exceed 300 µA. Maximum Flow. Measure the maximum free airflow with the flowmeter and compare it with recommended values in the table. (This measurement need not be made on low-volume suction machines, since their flows are generally very low.) Set the unit for maximum suction. Test the aspirator with the collection bottle(s) or canister(s) in place, but without patient catheters. Use a short piece of large-diameter tubing from the flowmeter to the device, with the correct size adapters inserted at the aspirator end. Any restrictions (e.g., internal adapters) will tend to reduce the free airflow. Rate of Vacuum Rise. This test is necessary only on tracheal, emergency, and intrauterine aspirators, where rapid vacuum rise is essential. Connect the vacuum gauge or pressure meter to one side of a T fitting and attach the T to the canister or collection bottle patient connector. Turn the unit on and set the unit for maximum suction. Occlude the open port of the T with a finger while using a stopwatch or watch with a second hand to measure the time required to reach maximum vacuum. Refer to the Aspirator Performance Values table to determine acceptable rise time values. Maximum Vacuum. Connect the vacuum gauge or pressure meter to the canister or collection bottle patient connector. Turn on the aspirator, adjust it to provide maximum vacuum, and record

2.2

2.3

this value. If a unit does not provide the expected maximum vacuum (see the Aspirator Performance Values table above), look for air leaks, especially in the collection bottle caps and hoses. Some low-volume aspirators have “low” and “high” settings; record the vacuum attained for each, measuring the low level first. Thermal intermittent aspirators (e.g., Gomco Models 764/5, 200/2000) do not reach maximum vacuum during the first few cycles, and it is necessary to wait 5 to 10 min until maximum vacuum is reached. 2.6 Vacuum Gauge Accuracy. Check the accuracy of the vacuum gauges on units so equipped at a vacuum level typical for primary usage. To make this measurement, connect the vacuum gauge or pressure meter to the fitting on the collection bottle intended for the patient catheter or tubing. Turn the unit on and adjust it to the desired vacuum reading on the machine’s gauge. Record this reading and that of the test gauge or meter. Readings should be within 10%.

2.4

3. Preventive maintenance
3.1 3.2 3.4 Clean the exterior and interior, if needed. Lubricate the motor and pump, if needed. Replace filter(s), hoses/tubing, fittings/connectors, if needed.

4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.

2.5

Before Returning to Use
Recharge battery-powered devices, or equip them with fresh batteries, if needed.

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Procedure/Checklist 449-0595

Autotransfusion Units
Used For:
Autotransfusion Units, Blood Processing [17-537]

Also Called: Cell Saver (a registered trademark of Haemonetics Corp. to be used only when referring to that device) Commonly Used In: Operating rooms Scope: Applies to machines used for intraoperative separation and cleaning of red blood cells recovered from surgical sites Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 6 months NA Interval Used By Hospital months months Time Required . . hours hours

Overview
Autotransfusion, or autologous transfusion, is the process of reinfusing a patient’s own blood rather than relying on banked stores of homologous blood. Several types of intraoperative autotransfusion devices are available today. The simpler systems consist of collection canisters or cardiotomy reservoirs that are filled through suction tubing originating at the operative site. These systems generally include a means of infusing proportioned quantities of anticoagulant as blood is aspirated, and a filtration system to remove clotted blood and other debris that may be aspirated with the blood. Processing systems use a centrifuge to separate, wash, and pack the red blood cells (RBCs) extracted from salvaged whole blood. This procedure applies to blood processing systems that employ a centrifuge to separate RBCs from whole blood aspirated from the surgical site. Currently marketed units perform essentially the same procedures in separating cells from whole blood; differences among the units are related primarily to the degree of machine automation. Prices of the units reflect that degree of automation.

During autotransfusion with these machines, blood that pools in the operative site is aspirated and simultaneously mixed with an anticoagulant, then deposited in a cardiotomy reservoir. After coarse filtration, the blood is either pumped or drained into the spinning centrifuge bowl. The lighter plasma separates from the RBCs and is discarded in a waste bag. Automated systems monitor the level of RBCs in the bowl with optical sensors and stop the centrifuge once the cells have filled the bowl. In manual operation, the operator must determine when the centrifuge bowl is full and initiate the next phase of processing, generally the RBC wash. During the RBC wash, cellular debris from ruptured cells, clots, and other contaminants are removed. RBC washing is accomplished by introducing normal saline into the full, spinning centrifuge bowl. Because saline is less dense than the RBCs, it disperses the cells and rises up through them, carrying debris out and into the waste bag. Automated systems will deliver a predetermined volume of saline during the wash phase; manual systems require that the operator monitor the clarity of the waste leaving the centrifuge bowl. When the waste fluid is clear, the wash phase is terminated.

084750 449-0595
A NONPROFIT AGENCY

5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri.org

Inspection and Preventive Maintenance System
The final stage of processing involves pumping the packed and washed cells into an infusion bag. The filled infusion bag is hung with an infusion line and a microaggregate filter to reinfuse the cells into the patient. The infusion bags are generally provided (without infusion lines or filters) with the disposable centrifuge bowls and tubing sets for each autotransfusion machine. While intraoperative autologous transfusion may be safer than donor transfusion, which carries the risk of cross infection and transfusion reactions, autologous transfusion is not without risk. Some rare complications currently associated with autotransfusion include air embolism, kidney dysfunction, and disseminated intravascular coagulation. Of these complications, the latter two are thought to be related to blood damage that occurs during the processing. Excessive centrifuge speed, overheating of the blood, and excessive vacuum applied during aspiration can cause RBC damage. Air embolism has generally been associated with the use of pressure infusors for reinfusion of recovered cells or infusion occurring concurrently with processing. Some autotransfusion machines are equipped with air-in-line detectors that are designed to detect air in the reinfusion line returning packed cells to the patient. (For more details about the risks associated with autotransfusion, refer to the Health Devices articles cited below.) Vacuum gauge, 0 to 600 mm Hg, or pressure meter with equivalent capabilities The following may be necessary during acceptance testing: Citrate solution to anticoagulate 2 L of blood, such as 80 g sodium citrate in 200 mL normal saline or CPD (citrate phosphate dextrose) anticoagulant solution (consult with pharmacy to determine correct concentration) 2 L of whole, fresh pig or cow blood anticoagulated with citrate (because of the risk of bloodborne pathogens, human blood should not be used for the procedures; animal blood may be obtained from a local slaughterhouse)

Special precautions
Although the disposable components of the autotransfusion machines are intended to contain blood during processing, blood may be spilled on the machine housing or components during processing. When working on external components (including the centrifuge well) and the machine housing where blood may have been spilled, it is prudent to wear examination gloves. If a unit is contaminated with blood, especially if the blood is still liquid, it should be decontaminated (preferably by a machine operator or central supply personnel). Verify that the centrifuge well is clean before working on the unit. In addition to gloves, wear a gown and eye protection while the machine is cleaned. (See Infection Control in the “IPM Safety” article behind the Guidance Tab in this binder for additional precautions and suggestions.)

Citations from Health Devices
Air embolism from autotransfusion units [Hazard], 1986 Jul; 15:210-2. Automated intraoperative processing autotransfusion machines [Evaluation], 1988 Aug; 17:219-42. Autotransfusion machines [Evaluation update], 1988 Dec; 17:371. Hemolysis and renal dysfunction associated with autotransfusion, 1990 Jan; 19:25-7.

Procedure
Before beginning the inspection, carefully read this procedure and the manufacturer’s instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also, determine if any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. For software-driven units, note the software revision number on Line 1.19 (System SelfTest) of the inspection form.

Test apparatus and supplies
Leakage current meter or electrical safety analyzer Ground resistance ohmmeter Leak-detect solution 1,000 mL graduated cylinder Stopwatch or watch with a second hand Bucket with capacity of at least 1 L Set of disposables for autotransfusion unit Stroboscopic tachometer

1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. (See Special Precautions.)

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Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

Autotransfusion Units
1.3 Casters/Brakes. If the device moves on casters, check their condition. Verify that they turn and swivel, as appropriate, and look for accumulations of lint and thread around the casters. Check the operation of brakes and swivel locks, if the unit is so equipped. Conductivity checks, where appropriate, are usually done more efficiently as part of a check of all equipment and furniture of an area. (See Procedure/Inspection Form 441.) AC Plug/Receptacles. Examine the AC power plug for damage. Attempt to wiggle the blades to check that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. If the device has electrical receptacles for accessories, verify presence of line power, insert an AC plug into each, and check that it is held firmly. If accessories are plugged and unplugged often, consider a full inspection of the receptacles. 1.5 Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with correct polarity. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. If the line cord is detachable (by the user), affix the cord to the unit so that it cannot be removed by the operator. (See Health Devices 1993 May-Jun; 22[5-6]:301-3.) Circuit Breaker/Fuse. If the device has a switch-type circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis and ensure that a spare is provided. Tubes/Hoses. Check the condition of all tubing and hoses in the unit. Be sure that they are not cracked, kinked, or dirty. Cables. Inspect any cables and their strain reliefs for general condition. Carefully examine cables to detect breaks in the insulation and to ensure that they are gripped securely in the connectors at each end to prevent rotation or other strain. Verify that there are no intermittent faults by flexing electrical cables near each end and looking for erratic operation or by using an ohmmeter. 1.10 Fittings/Connectors. Examine all gas and liquid fittings and connectors, as well as electrical cable connectors, for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. Verify that connections are secure. Gas fittings should be tight and should not leak. (If in doubt, check fittings using a leak-detect solution.) 1.12 Filters. Check the condition of all air filters. Clean or replace as appropriate and indicate this on Lines 3.1 or 3.4 of the inspection form. 1.13 Controls/Switches. Before changing any controls or alarm limits, check their positions. If any settings appear inordinate, consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Some units may store modifications of standard processing procedures in memory even when the power is shut off; consult the operator’s manual if there is any question about the effect of changing controls if they are not set back to their original positions. (If in doubt, have the machine operator review settings before using the unit.) Examine all controls and switches for physical condition, secure mounting, and correct motion. Check that control knobs have not slipped on their shafts. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.15 Motor/Pump/Fan/Compressor. Check the physical condition and proper operation of these components. Clean and lubricate as required, and note this on Lines 3.1 and 3.2 of the inspection form. (However, do not check these items until all necessary cleaning and lubrication is completed.) Inspect brushes (if present) of pump, centrifuge, and compressor motors for wear. If worn, replace. If drive belts are present, check them for wear and replace if needed. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, meters, gauges, and visual displays on the unit and charger (if so equipped). Be sure that all segments of a digital display function (see Item 1.19).

1.4

1.6

1.7

1.8

1.9

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Inspection and Preventive Maintenance System
1.19 System Self-Test. Many automated autotransfusion units have a software-based self-check feature that performs several diagnostic tests when the machine is powered up. Record the software version on the inspection form when the program is started. Verification of proper display and indicator function may also be checked during the self-check. 1.20 Alarms. Autotransfusion machines may have alarms, depending on the degree of automation of the unit. Some alarm conditions that should be checked (where appropriate) include full waste bag, empty wash reservoir, and open centrifuge cover. Induce alarm conditions to activate audible and visual alarms. Full waste bag alarms (present on some units) may be triggered by the weight of the bag or by the system’s volume-accounting system, which keeps track of how much fluid has been pumped into the waste bag. Empty reservoir alarms are typically triggered when the air-in-line detector senses that no fluid is in the line during the washing phase of processing. (Testing this alarm will also verify that the air-in-line detector is functioning.) Some autotransfusion machines may have centrifuge-cover interlocks that prevent the opening of the cover while the centrifuge is spinning; they may not alarm to warn that the cover is open. Consult the operator’s manual or the manufacturer to determine if the unit being tested has an alarm to detect an open centrifuge cover. (None of the tests in this section will require blood; water or saline may be used if fluid is required.) 1.21 Audible Signals. Operate the device to activate any audible signals. Confirm appropriate volume, as well as the operation of a volume control, if so equipped. If audible alarms have been silenced or the volume set too low, alert clinical staff to the importance of keeping alarms at the appropriate level. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible. 1.23 Accessories. Confirm the presence and condition of accessories, such as tools, separate air-in-line sensors, and cardiotomy reservoir clamps. 1.24 Clamp Valves. Inspect clamp valves on each unit, if so equipped, to determine if they are clean and in good condition. If material has accumulated on the clamps, clean as needed. Using the disposable autotransfusion set (or tubing of the same size and hardness), verify that the clamp valves work by installing the tubing in the valves so that at least 3 ft of tubing is available on one side of the valve. With the 3 ft section of tubing held in a vertical position and the clamp valve closed, fill the tubing with water to verify that water will not leak through the valve. Next, trigger the valve to open by operating the unit (consult manufacturer if it is not clear how to trigger valves to open). If clamps do not open or open sluggishly, consult the service manual or have the manufacturer repair or clean the valve. 1.25 Centrifuge Chuck. Inspect centrifuge chuck for wear or damage. Inspect entire centrifuge well for presence of debris. Install a centrifuge bowl in the chuck according to the operator’s manual, verify that the bowl is firmly seated and that, when the centrifuge is spinning, the bowl remains fairly quiet. If the chuck employs O-rings to secure the bowl, inspect the O-rings for wear or nicks; replace as necessary.

2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 Ω. If the system is modular or composed of separate components, verify grounding of the mainframe and each module or component. If the device is double insulated, grounding resistance need not be measured; indicate “DI” instead of the ground resistance value. If the device has an accessory receptacle, check its grounding to the main power cord. 2.2 Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Operate the device in all normal modes, including on, standby, and off, and record the maximum leakage current. Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off. This includes other equipment that is plugged into the

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Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

1 Clean exterior and clamps. 5 . so that all are grounded through a single line or extension cord. Check the rollers on pumps to make sure that they are running smoothly and that there are no unusual noises from bearings or other indications of excessive bearing wear. Measure centrifuge speed with a stroboscope tachometer illuminating the centrifuge bowl chuck while the centrifuge is spinning. then suction fresh citrated blood into the collection reservoir. as well as equipment plugged into a multiple-strip outlet (“Waber strip”). set it to deliver 500 and 1. testing with animal blood is optional. If a manufacturer-recommended procedure is available.1 Cycle Function. Generally. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. All Rights Reserved. Check the accuracy of vacuum pump regulation on units equipped with vacuum pumps by connecting a length of tubing to the vacuum port and to a vacuum gauge.4 Vacuum Pump. as needed.4 Lubricate per manufacturer’s instructions. Chassis leakage current to ground should not exceed 300 µA. verifying that the system will detect the packed RBC level. and you will be testing with blood. (This may require triggering of some sensors for the more automated units. as appropriate. 2. Vacuum levels should be within 50 mm Hg of the displayed value at full vacuum. Blood should be collected in a solution of 8 g of sodium citrate dissolved in 200 mL of normal saline for every 2 L of blood required.3 Roller Pumps. contact the manufacturer to inquire about adjustment. A piece of tape may be applied to the chuck to facilitate speed determination. Since there is no history of problems reported for new units. and collect the volume for a convenient time interval in a calibrated 1. 2 L of blood is more than adequate for testing. immerse both ends of the tubing in a bucket of saline solution or water at atmospheric pressure and turn on the pump. Other controls should be in their normal pre-use positions. Flows should be accurate to within 5% of the setting or the manufacturer’s specifications. consider including this testing as part of in-service instruction. consider performing the following test. and centrifuge bowl O-rings.Autotransfusion Units primary device’s accessory receptacles. Centrifuge Speed. Using tubing of the correct size and hardness in the pump. contact the manufacturer if it is not clear how to get the pump to run. use pig or cow blood to confirm complete functioning. 3. 2. 3. other solutions will not activate sensors.5 Before returning to use Make sure that all controls are set properly. For the manufacturer-recommended test protocol. 2. Replace motor brushes. install the disposable components. Centrifuge speed should be within 10% of the specified speed or within the range specified by the manufacturer. 4.) To check pump accuracy. Preventive maintenance 3. drive belts. Set alarms loud enough to alert personnel in the area in which the device will be used. Inspection and Preventive Maintenance System ©1995 ECRI. If the manufacturer does not provide a way to perform this test. In addition. Operate the unit according to the operator’s manual. contact your representative. 4. If the autotransfusion machine is new to your clinical staff.000 mL graduated cylinder. Attach a Caution tag in a prominent position to alert users that control settings may have been changed. To test with animal blood.2 3.000 mL/min. If centrifuge speed is outside of acceptable specification. verify that the blood-level detection system (in automated units) and the rest of the autotransfusion unit functions properly through one or more complete cycles.

Rocking [10-363] Beds. If a bed is occupied at the time its inspection is due and the patient cannot leave the bed for the few minutes required for the inspection. for Special Care Beds Type Major Minor ECRI-Recommended Interval 12 months NA* Interval Used By Hospital months months Time Required . treatment tables (not including OR tables). Low-Air-Loss [17-593] Beds. Electric motors tend to have leakage currents that increase with age and use. and afford the patient comfort and convenience. hours hours * Special care beds — including rocking beds (also called kinetic treatment tables). Circle Electric [10-345] Beds. PA 19462-1298. flotation therapy beds. Obese [15-760] Beds. In most hospitals. they can provide long service. turning frames. Examination/Treatment [13-958] Commonly Used In: Most patient care areas Scope: Applies to electrically operated patient beds. and air-fluidized and low-air-loss flotation therapy beds — should receive a minor inspection at least every six months.org . Electric. bed rails can be checked and repaired before they fail to restrain a patient. for most Electric Beds. Properly used and maintained. circle beds. Electric Used For: Beds. responsibility for inspection and preventive maintenance of electric beds rests with the plant or facilities engineering department. Air-Fluidized [16-889] Beds. Overview Electrically operated beds are in widespread use in most hospitals. 17:3). Electric [10-347] Beds. and the line cord. can often detect impending failures at a stage where correction is relatively simple (e. primarily because of their potential electrical risks. and a variety of specialty electric beds designed for prevention or treatment of pressure sores (decubitus ulcers) or burns. in addition to the annual major inspection (see Health Devices 1988 Jan. Tilt [16-991] Tables. and control units on beds are often subject to abuse by patients and personnel. Low for most Electric Beds. Hospital Assessment. nonelectric as well as electric. Periodic inspection of electric beds is necessary. Inspection of electric beds must be correlated with bed occupancy and coordinated with nursing personnel or the admissions office. Flotation Therapy [10-348] Beds. turning frames. save much nursing staff time. Birthing [15-732] Beds. request that the floor nurse advise the maintenance department when the inspection can be performed. a missing IV pole can be replaced before it is urgently needed).. with additional tests for special features of these units Risk Level: ECRI Recommended. plugs. Medium for Special Care Beds.g. Periodic inspection of all beds. Plymouth Meeting. .Procedure/Checklist 402-0595 Beds. rather than 009032 402-0595 A NONPROFIT AGENCY 5200 Butler Pike. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri.

Casters/Brakes. graphited oil. 12:177. 15:299-316. as appropriate. If damaged. 11:302. loose fasteners. 7:152-3. 1987 Jan. it is important that the documentation of their inspection be thorough and consistent with that of the clinical engineering department. Circuit Breaker/Fuse. if the bed is so equipped. If the unit has a switchtype circuit breaker. and ensure that a spare is provided. Procedure Before beginning an inspection. 15:317-8.5 1. (See also Erratum. check its value and type against that marked on the chassis. 1. be sure that you understand how to operate the equipment and the significance of each control and indicator. Electric beds can kill children [Hazard update]. 17:101-2. 1983 Jun. Electric beds [Evaluation]. 1986 Nov. 19:495-6. 1978 Apr-May. 1988 Mar. Attempt to wiggle the blades to determine that they are secure. 1991 Dec. Be sure that they hold the cord securely. 1978 Sep. Look for accumulations of lint and thread around the casters. Electric beds: Do not use in psychiatric wards [Hazard]. 1987 Mar-Apr. 1987 Mar-Apr. Examine the bed frame for cleanliness and general physical condition. cut out the defective portion. 16:109-10. Citations from Health Devices Electrical safety of electrical beds. 1982 Sep. 16:118. grease) 1. Never get underneath a bed while the controls are being operated. replace the entire cord or. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Special care beds require special attention [Hazard]. carefully examine the plug and use Hospital Grade plugs on all electric beds. 7:290. Examine the AC power plug for damage. Be sure to wire a new power cord or plug with the same polarity as the old one. especially on special care beds.g. Electric bed plugs are especially subject to physical abuse. Therefore.) Amedco electric hospital beds [Hazard].3 1.7 2 Inspection and Preventive Maintenance System ©1995 ECRI. walkaway down) that could result in potentially serious crushing injuries. and lubrication with the power cord unplugged.6 Special precautions Keep fingers and clothing away from all moving parts during inspection.4 Test apparatus and supplies Leakage current meter or electrical safety analyzer Ground resistance ohmmeter Lubricants (20-weight low-detergent oil. However. Be sure that all assembly hardware is present and tight. If the bed moves on casters. If the device is protected by an external fuse. Shake the plug and listen for rattles that could indicate loose screws. Electric beds — A status report. because these beds are also medical devices.1 Frame. 15:177. cleaning. check that it moves freely. 18:323-5. Electrical safety of electric beds [User Experience NetworkTM]. stripped threads). If any damage is suspected. Line Cord.. and be sure that they turn and swivel. 1. Electric beds and the pediatric patient [Hazard]. Water mattresses on electric beds [Consultant’s Corner]. Some controls will cause continued motion even after the switch is released 1. 16:33. caster security. 12:203-7. 1989 Sep.Inspection and Preventive Maintenance System with clinical engineering. open the plug and inspect it. Examine the strain reliefs at both ends of the line cord. . Check mechanical integrity and degradation (weld cracks. Strain Reliefs. Inspect the cord for signs of damage. Check the operation of brakes and swivel locks. Perform parts inspection. Qualitative tests 1. All Rights Reserved. Hill-Rom electric beds [User Experience NetworkTM]. if the damage is near one end. check their condition. Electric beds in pediatric areas [Consultant’s Corner]. Electric beds can kill children [Hazard update]. carefully read this procedure and the manufacturer’s instruction and service manuals. 1986 Nov. 1986 Jun. Verify smooth and secure operation of siderails. AC Plug. (e. 1983 May.

stored behind the headboard). secure mounting. 16:109-10 and 1989 Sep.g. measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. condition.g. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. All Rights Reserved. and bright.g. if present (e. motors. turer that they meet the requirements for protection against tampering set forth in UL 544.13 Controls/Switches. verify with the manufac- 2.. Follow manufacturer’s recommendations for lubrication (but do not check Line 3. 1987 Mar-Apr. 1.5 Ω. standby. 3 . Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors of each end to prevent rotation or other strain.2 Clean the exterior and interior (e. including on. Note any unusual sounds or other deviations from normal performance of the controls themselves.g. If the bed should be equipped with an IV pole or a manual handcrank (e. 1. the motors. for physical condition. both patient and nurse actuated. The IV pole’s elevating latch or thumbscrew should function easily.3 3..2 2. Before moving any controls. electrical safety analyzer. mechanisms). Inspection and Preventive Maintenance System ©1995 ECRI. mechanisms. Electrical contact pins or surfaces should be straight. check with the manufacturer to determine the modification procedure to disable the feature..1 Grounding Resistance. in special care beds). Operate the device in all normal modes.10 Fittings/Connectors. Measure chassis leakage current to the chassis of the unit with the grounding conductor of plug-connected equipment temporarily opened. Quantitative tests 2.2 on the inspection form until all necessary lubrication has been completed). Supplemental Tests. labels. Operate each of the controls in both directions to the full extent of its limits.1 3. 2. We recommend a maximum of 0. and mechanical integrity.15 Motors/Mechanisms.. alignment. pendants. For older beds. Before returning to use Place the bed in its lowest position. Examine all electrical cable connectors for general condition. Note the general condition of the bed and mattress. check their positions. 1.25 Function and Limits of Patient Controls. This recommendation is based on incidents in which children have been fatally crushed (see Health Devices. 1. The bed should descend only as long as the down button is pressed. This applies to all areas of the hospital. Verify operation of patient lockout switches. and record the maximum leakage current. the motors. Leakage Current. or multimeter with good resolution of fractional ohms. Check that all necessary placards. Lubricate motors.9 Cables. and freedom from accumulated dirt and lint.g. motion should stop as soon as the button is released. 1. Leakage current from the bed frame should not exceed 300 µA. Inspect for general cleanliness. Operate each of the controls in both directions to the full extent of its limits. Check membrane switches for membrane damage (e. 18:323-5). Section 23C4. 1.Beds.23 Accessories. If in doubt about new beds. and correct motion. or the limits. Pedestal-style electric beds should not have a walkaway down feature unless the bed has ULlisted controls. Note any unusual sounds or other deviations from normal performance of the controls themselves. from fingernails or pens). clean. Inspect IV sockets for cleanliness. or the limits. Using an ohmmeter. Walkaway down capability can be included on four-poster beds. Preventive maintenance 3. 4. interconnecting) and their strain reliefs for general condition.22 Labeling. as well as all gas and liquid fittings and connectors. verify its presence and condition. and off.. Check any special features of the particular model for condition and operation.24 Function and Limits of Nurse Controls/Lockouts. This limit applies whether the bed is used in a general or special care area. and instruction cards are present and legible. Inspect the cables (e. 1. Examine all controls and switches. Electric 1.

Plymouth Meeting.Procedure/Checklist 454-0595 Blood Pressure Monitors. The oscillometric method of determining arterial blood pressure does not require a transducer under the 084753 454-0595 A NONPROFIT AGENCY 5200 Butler Pike. PA 19462-1298. does not include manual sphygmomanometers (see Procedure/Checklist 424) or invasive blood pressure monitors or transducers (see Procedure/Checklist 434 or 435. and they have proven sufficiently accurate for many clinical applications. many automatic blood pressure units can be programmed for readings at regular intervals and will sound an alarm if a patient’s blood pressure exceeds preset limits. . Electronic Indirect Used For: Sphygmomanometers. or a change in medication.org . such as variations in user techniques and hearing acuity and the difficulty of obtaining measurements on hypotensive patients. This enables the system to directly determine both systolic and diastolic values but not mean arterial pressure (MAP). respectively). Electronic. Hospital Assessment. The use of these devices may help to overcome some of the problems associated with manual sphygmomanometry. Electronic [16-157] Sphygmomanometers. Medium. noninvasive techniques are most often used because of their low risk and simplicity. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. Manual [16-174] Also Called: Noninvasive blood pressure (NIBP) units Commonly Used In: All patient care areas Scope: Applies to electronic noninvasive blood pressure monitors with either automatic or manual inflation. hours hours Overview Electronic sphygmomanometers noninvasively measure and display a patient’s arterial blood pressure. Arterial blood pressure measurement is an essential indicator of physiologic condition. it is critical to the ongoing management of patients under anesthesia or undergoing drug and other therapies to determine the need for blood. can be used on physiologic monitoring systems and vital signs monitors that include NIBP measurement Risk Level: ECRI Recommended.g. plasma expander). Some of these units display a MAP that is calculated from the systolic and diastolic values using an empirically derived algorithm. Electronic. As one of the most frequently used diagnostic tests. Although invasive techniques for measuring blood pressure may provide greater accuracy and permit continuous measurement during cardiac and respiratory cycles.. a volume substitute (e. Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . In addition. Two primary methods of determining blood pressure are used with noninvasive electronic blood pressure monitors. Some units can display heart rates based on the blood pressure waveform. The auscultatory method uses a transducer under the occluding cuff to detect arterial sounds (Korotkoff sounds) as cuff pressure is gradually lowered from above the systolic pressure. Automatic [16-173] Sphygmomanometers. Hypotensive patients and patients about to go into shock can be very difficult to monitor with this method because the Korotkoff sounds are difficult to detect at low pressures.

and that there are no signs of spilled liquids or other serious abuse. this average. if the two algorithms are not exactly matched. (See also 1986 Aug. can or pipe) with a 3 in to 4 in outer diameter Stopwatch or watch with a second hand NIBP simulator Procedure Before beginning an inspection. 20:79-80. This method may be more reliable than auscultation on hypotensive patients and patients who are likely to become hypotensive. This method detects volume displacements that originate within the artery (as cuff pressure is reduced) and that are sensed as pressure oscillations in the occluding cuff. AC Plug.. The oscillometric method is used to measure MAP. Attempt to wiggle the blades to check that they are secure. If the device is mounted on a stand or cart. replace the entire cord or. A third method. Check the operation of brakes and swivel locks. they are not necessarily useful in evaluating device accuracy. However. 15:247 and 1986 Nov. open the plug and inspect it. Since NIBP monitors calculate their readings based on an algorithm. All Rights Reserved.) 1. Simulators also provide a means of evaluating the dynamic performance of the NIBP monitor. 15:187-208.4 Citations from Health Devices Automatic sphygmomanometers [Evaluation]. If any damage is suspected. Inspect the cord for signs of damage.5 2 Inspection and Preventive Maintenance System ©1995 ECRI.2 1. Examine the exterior of the unit for cleanliness and general physical condition. 1986 Jul. Examine the AC power plug for damage. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. If it is attached to a wall or rests on a shelf. Physiologic patient monitors [Evaluation]. if the damage is near one end. check the security of this attachment. Be sure that plastic housings are intact. Line Cord. One side of the sensor is positioned above the artery and detects the signal generated by the Korotkoff sounds and the oscillometric pressure wave. The point of maximal oscillation corresponds to the MAP. It is also necessary to take several readings at each setting and average them. and the alarm capabilities. the simulator has an internal bladder). There are several oscillometric NIBP simulators on the market.000. 1991 MarApr. Test apparatus and supplies Leakage current meter or electrical safety analyzer Ground resistance ohmmeter Calibrated pressure gauge or meter (0 to 300 mm Hg) Y connector compatible with cuff tubing connectors Cylindrical object to simulate an arm (e. be sure that you understand how to operate the equipment. examine the condition of the mount. These devices attempt to simulate the dynamic signals that the occlusive cuff would sense if placed on a patient’s arm. This method typically uses a dual-head sensor that is located under the occluding cuff. isolating the signal that identifies the systolic and diastolic pressures. is a composite of the two techniques described above. The opposite side of the transducer detects only the oscillometric signal. even when Korotkoff sounds may be too weak to measure systolic and diastolic pressures. while they are useful in looking at long-term trends of device performance. and the simulators use a similar algorithm to generate their signals. Verify that they turn and swivel. . then the leak test will need to be repeated with the patient cuff in place. 20:81-136. as appropriate. If damaged. If the simulator does not use the NIBP monitor’s patient cuff (i. Physiologic monitoring and the standard of care. and overpressure test. costing approximately $4. this method filters out extraneous signals from the Korotkoff sounds. Casters/Brakes. if the unit is so equipped. cut out the defective 1. over time.1 Chassis/Housing.g. Mount/Fasteners. should remain constant for each individual NIBP monitor. By subtracting these two signals.Inspection and Preventive Maintenance System occluding cuff and is the most common method used. the significance of each control and indicator. 1. leak test. If the device is mounted on a cart or stand. check the condition of its casters. 1991 Mar-Apr. Systolic and diastolic pressures may be determined by special measurement techniques or clinically tested algorithms. carefully read this procedure and the manufacturer’s instruction and service manuals.. 15:317. and look for accumulations of lint and thread around the casters. the differential sensor technique. that all hardware is present and tight. Qualitative tests 1.3 1. Shake the plug and listen for rattles that could indicate loose screws.e. then what the simulator states the pressure should be may differ from the pressure that the monitor indicates. The devices also have a test mode that can provide an easier means of performing the static accuracy test.000 to $5.

3 . and visual displays on the unit. 1. auto deflate) function. 1. Confirm appropriate volume. Be sure that the battery is recharged or charging when the inspection is complete. All cuffs should be clean and in good condition with no torn stitching. manual or automatic) against the manufacturer’s specifications. If the device is protected by an external fuse. If audible alarms have been silenced or the volume set too low.6 Strain Reliefs. Operate the device to activate any audible signals.20 Alarms. or dirty. labels..g.17 Battery. label it with the date. 1. check their positions. If any settings appear inordinate (e. if so equipped.. 1. gauges..19 User Calibration. battery is charged and can hold a charge. as well as positive stopping. Examine all fittings and connectors for general condition. and correct motion.g. as well as the operation of a volume control.11 Transducers (non-oscillometric units).23 Accessories. 1. 1. smaller cuffs in a pediatric area). Fittings should be tight (or within manufacturer’s specifications) and should not leak. Check operation of battery-operated power-loss alarms. kinked. 1. be sure to check that each control and switch performs its proper function. If the unit has an alarm-silence feature.g. and the bulb (if present).10 Fittings/Connectors. Induce alarm conditions to activate audible and visual alarms. During the course of the inspection. It may not be possible to check out all alarms at this time. Be sure that they are not cracked. confirm the operation of all lights.) Check battery condition by activating the battery test function or measuring the output voltage.. the cuff.15 Pump. check the method of reset (i.18 Indicators/Displays. secure mounting.. make sure that the keying is correct. Check that any associated interlocks (e. Check that Velcro closures hold firmly. Check that control knobs have not slipped on their shafts. Tubes/Hoses/Bulbs. Check that all necessary placards. (The inspection can be carried out on battery power to help confirm adequate battery capacity. at a nearby nursing station). meters. Examine the strain reliefs at both ends of the line cord. 1. alert clinical staff to the importance of keeping alarms at the appropriate level. Where a control should operate against fixed-limit stops. Examine all controls and switches for physical condition. Circuit Breaker/Fuse. 1. Operate the unit on battery power for several minutes to check that the Inspection and Preventive Maintenance System ©1995 ECRI. conversion charts. Confirm the operation of a charging indicator. Electronic Indirect portion. 1. These should correspond to physical characteristics of the patients on whom the instrument is likely to be used (e.21 Audible Signals. Be sure to wire a new power cord or plug with correct polarity.Blood Pressure Monitors.e. Be sure that all segments of a digital display function.13 Controls/Switches.g. Confirm that any necessary transducers are on hand and check their physical condition. Check membrane switches for membrane damage (e. check that it moves freely.22 Labeling. pens). Look for signs of degradation or cracking of the bladder. alarm limits at the ends of their range). since some may require abnormal operating conditions that will be simulated later in this procedure. Also check line cords of battery chargers. indicators. Be sure that they hold the cord securely. 1. if readily accessible.8 1. Verify that the calibration function operates. Check the physical condition and proper operation of this component. All Rights Reserved. check for proper alignment. Use of an improperly sized cuff can cause significant errors in measuring blood pressure.7 1. all hoses. Record the settings of those controls that should be returned to their original positions following the inspection. Clinical personnel should be instructed never to substitute an improper cuff. Inspect the physical condition of batteries and battery connectors. During the course of the inspection. Check the condition of all tubing. If keyed connectors are used.g. from fingernails. If the device has a switchtype circuit breaker. Verify that appropriate cuff sizes either are stored with the unit or are readily available (e. if so equipped. If it is necessary to replace a battery. check its value and type against that marked on the chassis and ensure that a spare is provided. and instruction cards are present and legible. consider the possibility of inappropriate clinical use or incipient device failure. Replace loose or cracked tubing. Before changing any controls or alarm limits.. 1.

If the device is double insulated. cuff location (i. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. Leakage Current. 1. Calibrate per manufacturer’s instructions. grounding resistance need not be measured. If a unit does not allow testing this way. unless the device has an algorithm that interpolates the reading between pulses. We recommend a maximum of 0. The readings on the unit and the standard gauge should not differ by more than 3 mm Hg. Lubricate per manufacturer’s instructions. If the rate is faster. or multimeter with good resolution of fractional ohms.Inspection and Preventive Maintenance System If the unit has a printer/recorder. 1.3 3. Displayed heart rate should correspond to manually palpated rate within 10%. Connect the blood pressure set to a calibrated gauge or meter as shown in Figure 1.1 Grounding Resistance.2 2.2 3. Chassis leakage current to ground should not exceed 300 µA. and record the maximum leakage current. In addition. that the paper folds smoothly. Wrap the cuff around a simulated limb.. Confirm the operation of the control that enables manual deflation. perform the following test. indicate “DI” instead of the ground resistance value.1 3. electrical safety analyzer.3 Air Leakage. Preventive maintenance 3.e. standby. measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. Test setup. and batteries if needed. 4. Connect the cuff to yourself or a volunteer. Differences in readings may be due to technique. Inflate the cuff (use the calibration function) to about the maximum scale indication. 4.4 Heart Rate.5 Ω. check to see that it operates when it is supposed to. The nurse’s reading and the unit’s reading should not differ by more than 10% mm Hg. including on. verify grounding of the mainframe and each module or component. Inflate the system to around 200 mm Hg with either the squeeze bulb or the unit’s calibration mode. and off. Operate the device in all normal modes. Replace tubing. hoses. 2.4 at the same time (for major inspection).1 Accuracy on Volunteer. and verify that it cycles through the measurement correctly. 2. and time (if not 4 Inspection and Preventive Maintenance System ©1995 ECRI. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. All Rights Reserved. Repeat the test for a pressure around 120 mm Hg and 80 mm Hg. Using an ohmmeter. connectors. This rate should not exceed 15 mm Hg/min.10 Pressure Accuracy. The deflation rate should be 2 to 6 mm Hg/sec. If it does.25 Operation on Volunteer. Connect the blood pressure set to a pressure gauge or meter as shown in Figure 1. Perform Item 2. Figure 1. If the system is modular or composed of separate components. 3. cuffs. 2. . right or left arm). check all fittings and repeat the test.4 Clean as needed. recheck all fittings and repeat the test.24 Deflation Switch. Read the indicator after 1 min to determine the rate of pressure loss in mm Hg/min. and that the printout is accurate and legible. Check the unit’s performance by comparing measurements made by a nurse to the blood pressure readings with the unit. an alternative leakage measurement can be used. Apply the cuff to yourself or a volunteer. 2. Quantitative tests 2. activate the unit. Wrap the cuff around a simulated limb.

Blood Pressure Monitors. Electronic Indirect taken simultaneously). Recharge battery-powered devices or equip with fresh batteries if needed. Using the simulated limb setup in Figure 1. consider having another qualified person obtain the manual reading before contacting the manufacturer. All Rights Reserved. It should deflate at a point no higher than 330 mm Hg. 5 . Set alarms loud enough to alert personnel in the area in which the device will be used. Inspection and Preventive Maintenance System ©1995 ECRI. 4. inflate the cuff to the point of auto deflation activation. Before returning to use Make sure that all controls are set properly.2 Auto Deflate Function. If significant differences are obtained on repetitive tries. Other controls should be in their normal pre-use positions.

be sure you understand how to operate the equipment.org . emergency department. 1985 MarApr. 1977 Jul. 15:331. Central/Peripheral [10-776] Commonly Used In: Special care units. PA 19462-1298. central venous pressures.. . indirect manual blood pressure measuring units (see Procedure/Checklist 424) or electronic indirect blood pressure monitors (see Procedure/Checklist 454). 1982 Nov. operating rooms. 6:236. ECRI-Recommended Type Interval Major Minor 12 months NA Interval Used By Hospital months months Time Required . 1982 Nov. Hospital Assessment. Invasive Used For: Pressure Monitors. or mean arterial pressures. Alternative in-use calibration techniques. blood pressure transducers are covered in Procedure/Checklist 435 Risk Level: ECRI Recommended. Procedure Before beginning the inspection. Also determine whether any special inspection and preventive maintenance procedures or frequencies are recommended by the manufacturer. Blood. However. Electrical isolation of blood pressure channels [User Experience NetworkTM]. hours hours Overview Monitoring blood pressure in addition to the ECG provides a more comprehensive view of cardiovascular status than the ECG alone can provide. and the alarm capabilities. High. does not apply to noninvasive. uterine pressure monitors used in conjunction with fetal heart monitors) that use the same measurement principles. and pulmonary artery wedge pressures. 12:24. Plymouth Meeting. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. Venous. Test apparatus and supplies Leakage current meter or electrical safety analyzer Ground resistance ohmmeter Transducer simulator Transducer connector (without transducer attached) or small-diameter probe for leakage current meter to gain access to terminals on monitor (acceptance testing only) Citations from Health Devices Blood pressure readings — Cuff versus monitor [Consultant’s Corner]. Patient monitoring systems [Evaluation]. General/Invasive [16-764] Manometer Sets. Air embolism during calibration of invasive blood pressure monitoring systems [Hazard].g.Procedure/Checklist 434-0595 Blood Pressure Monitors. 1986 Dec. cardiac catheterization laboratories. invasive blood pressure monitoring requires more skill and involves greater risk. Blood pressure monitors are used to monitor systolic. the significance of each control and indicator. 12:22-5. often included as a component of physiological monitoring systems Scope: Applies to invasive blood pressure monitors and is adaptable to other physiologic pressure monitors (e. diastolic. 009009 434-0595 A NONPROFIT AGENCY 5200 Butler Pike. 14:143. carefully read this procedure and the manufacturer’s instruction and service manuals.

a gain control at maximum. Moreover. 1. As long as the transducer-monitor combination is accurate to within 5% or ±2 mm Hg of a given static pressure. without the need to maintain a well-calibrated pressure transducer. Shake the plug and listen for rattles that could indicate loose screws. include the control or serial number of the transducer used to test the monitor (unless a simulator is used). Check membrane switches for membrane damage (e. The simulator can be used to test monitor accuracy alone. pens). test all the monitors in one area with a transducer simulator (these devices were evaluated in Health Devices 1980 Jan. examine the condition of the mount. Also. these tests are usually performed during the ECG Monitors inspection (see Procedure/Checklist 409) and are recorded on that form. bent connector pins.g..4 AC Plug.2 2 Inspection and Preventive Maintenance System ©1995 ECRI. and ensure that a spare is provided. Examine the exterior of the unit for cleanliness and general physical condition.g. Examine the AC power plug for damage. attached to a wall or rests on a shelf. If damaged. Be sure that plastic housings are intact. Inspect the cables (e. If the device is protected by an external fuse. we recommend using a pressure simulator for testing pressure monitors. 9:59) or one transducer that is known to be accurate. the cost of a basic static pressure simulator is less than the cost of a pressure transducer. if the damage is near one end. both the monitor and the transducer must be more accurate than this. 1. then test all the transducers in that area (see Procedure/Checklist 435) using one monitor. Where a control should operate against fixedlimit stops. from fingernails. If any of them appear inordinate (e. . reusable cables for disposable transducers) and their strain reliefs for general condition. open the plug and inspect it. Strain Reliefs. check their positions. Since the criteria apply to the measurement system.1 Chassis/Housing. Examine the strain reliefs at both ends of the line cord. Attempt to wiggle the blades to determine that they are secure. Line Cord. If any damage is suspected. replace the entire cord or. If the device has a switchtype circuit breaker. When filling in the identifying information at the top of the form. If it is 1. All Rights Reserved. Therefore.Inspection and Preventive Maintenance System This procedure is applicable to a stand-alone blood pressure monitor or a pressure module or a section of a multiple-parameter physiologic patient monitor. cracks.6 1. Examine all controls and switches for physical condition.5 1. alarm limits at the ends of their range). and correct motion. Before moving any controls and alarm limits. 1. consider the possibility of inappropriate clinical use or of incipient device failure. Be sure that they hold the cord securely. that necessary assembly hardware is present and tight. Testing the accuracy of blood pressure monitors and transducers presents a practical problem.. confirm that transducers are on hand. excessively worn pin receptacles). clean. If they are normally stored with the unit. a transducer alone cannot be used to establish the accuracy of the monitor. check that it moves freely.. cut out the defective portion. check its value and type against that marked on the chassis.. During the course of the inspection. For efficiency.11 Transducers.g. as well as positive stopping. secure mounting. Record the settings of those controls that should be returned to their original positions following the inspection. Clinical requirements for blood pressure measurements call for an accuracy of ±5% for arterial pressure ranges and ±2 mm Hg for venous or pulmonary pressure measurements.10 Fittings/Connectors.13 Controls/Switches. check the security of this attachment. If the device is mounted on a stand or cart.9 1. check for proper alignment.7 1.g. Mount. and lacks any signs of damage (e. the monitor and transducer can be considered acceptably accurate. Be sure to wire a new power cord or plug with the same polarity as the old one. You need not perform Items 1. Qualitative tests 1. Circuit Breaker/Fuse.7 each time a different monitoring function of a multiple parameter monitor is inspected. be 1.2 through 1. 1. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors of each end to prevent rotation or other strain. Inspect the cord for signs of damage. Verify that the connector for the transducer cable is secure. Cables. and that there are no signs of spilled liquids or other serious abuse. We have found that most pressure monitor and transducer problems result in either complete failure of the unit or relatively large errors. and check their physical condition.

or multimeter with good resolution of fractional ohms. 1. 2. verify grounding of the mainframe and each module. Check the monitor while on and off and record the maximum leakage current. should be the difference between the systolic and diastolic pressures. 1.24 Pressure Modes. Although considerably less convenient. 3 . Plug the transducer simulator into the monitor and zero it. which does not usually include this calibration resistor. Use the transducer intended for use with the monitor for this test. 1. Confirm that the calibration function operates and that the calibration or gain adjustment. and tubing may be substituted for the transducer simulator.2 Leakage Current. (A more quantitative and reproducible test can be performed if a transducer simulator with a dynamic pressure waveform output is available. However. During the inspection.g. Verify that the zero-adjustment and any calibration controls function properly. This test checks the monitor’s accuracy and linearity. measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and nonanodized) metal on the chassis. it is important to understand all of the alarm capabilities and remember to check them at the appropriate time during the procedure.10 Accuracy. and the diastolic pressure lowest. Quantitative tests 2. the indicated mean value may vary depending on the waveform and monitor used.5 Ω. We recommend a maximum resistance of 0. indicators. The pulse pressure. If the device has an accessory outlet. if user adjustable. manual or automatic) against the manufacturer’s specifications. electrical safety analyzer. diastolic. high blood pressure). Record values from only one mode (the least accurate). Measure the leakage current from the monitor chassis with the grounding conductor temporarily opened. Be sure that all segments of the digital display function.19 User Calibration. If the monitor has an alarm-silence feature. Invasive sure to check that each control and switch performs its proper function. provides an adequate range on both sides of the correct adjustment point. the qualitative test is adequate. The most convenient method for testing the monitor’s accuracy is with a transducer simulator that contains a resistive network. and visual displays.. meters. 1. and indicate on the form which mode was recorded. High (Arterial) Pressure Range. a 0 to 300 mm Hg pressure gauge or meter. Connect the stem of the Y connector to the transducer and the Y connector arms to the sphygmomanometer squeeze bulb and pressure gauge (see Figure 1).20 Alarms. check its grounding to the main power cord. All Rights Reserved. a Y connector. Normally. The monitor should be zeroed as it normally is during clinical use (with the transducer open to atmospheric pressure). the monitor’s calibration function will not operate with a transducer simulator.Blood Pressure Monitors.18 Indicators/Displays. Test pressures are 100 mm Hg and maximum (or 200 mm Hg) for the systolic. diastolic. the pressure monitor should measure to within 2% of a given static pressure (or 1 mm Hg at pressures below 50 mm Hg). confirm the operation of all lights. Using an ohmmeter. a sphygmomanometer squeeze bulb. If the system is modular. With such units. Be sure that the dome is properly attached to the Inspection and Preventive Maintenance System ©1995 ECRI. the mean pressure lower.1 Grounding Resistance. and mean arterial pressures by switching the transducer simulator between two pressure settings and noting that the indicated pressure in the systolic mode is highest. Zero the monitor with a transducer or transducer simulator attached. Operate the device in such a way as to activate each audible and visual alarm. and mean arterial modes. and we do not recommend purchasing a dynamic simulator solely for this purpose. an accurate pressure transducer. 2. check the method of reset (i. the monitor will read approximately the same in each mode. 2. if available. When using a pressure simulator. Verify that the monitor correctly indicates systolic.) Because some monitors do not compute the true mean.. Although it may not be possible to verify the operation of all alarms at this time (e. gauges. Some monitors have a calibration resistor inside the transducer cable connector.e. Chassis leakage current to ground should not exceed 300 µA. making sure that the zero adjustment is not at an extreme setting.

Low Pressure Range. until the alarm activates. Figure 1. Suggested test pressures are 10 mm Hg and maximum (or 20 mm Hg). respectively. Before returning to use Return alarms and other controls to their preinspection settings. 100 and 180 mm Hg. The overall accuracy of the transducer monitor system should be within 5% of a given static pressure (or 2 mm Hg at pressures below 50 mm Hg). . rather than having isolated electronic circuitry. Set the alarm at appropriate low and high settings (e. Determine whether the unit is of an isolated input design to decide on appropriate leakage current limits from each transducer connector terminal to ground. 4. Be sure the monitor is accurately zeroed in each range before taking measurements. Repeat the pressure accuracy test. 3. Preventive maintenance 3. for the venous and pulmonary ranges. If it is of isolated design. All Rights Reserved. Record the actual values on the form. determine whether it is introduced by the transducer. Accuracy should be within 1 mm Hg if a blood pressure transducer is used or 2 mm Hg if a transducer is used. 2. and test for the actual alarm values by varying the applied or simulated pressure. or both by using another transducer (or pressure simulator) to test the monitor or another monitor to test the transducer. compare it to the manufacturer’s specification and arrange for adjustment or repair. If the alarm delay is excessive. which must be taken into account when conducting this test.12 Alarm Accuracy. 2. as described in Item 2. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. If not labeled on the front panel. monitor. set appropriate applied or simulated pressures and raise and lower the high and low alarm settings.g. Many monitors have an alarm delay (up to about 11 sec).10. Test the monitor as described previously. especially if a disposable dome is used. Alternatively. Pressure accuracy test transducer. The unit should alarm within 5% of the set value..11 Accuracy. if appropriate. performing this test on such a monitor may damage the unit. 4 Inspection and Preventive Maintenance System ©1995 ECRI. If the error is excessive. Some blood pressure monitors rely upon isolation at the transducer.Inspection and Preventive Maintenance System respectively).1 Clean the exterior. measure the currents to each transducer connector terminal. check with the manufacturer to see if the monitor is rated for this type of isolation test before proceeding. Perform the isolation test only if your monitor is designed with patient input isolation from ground.

is it widely agreed that blood/solution warmers should be used. Although overtemperature alarms are considered a necessary feature. those with little or no control over bath temperature) typically used for warming and/or thawing blood products in the clinical laboratory or to pretransfusion microwave (radio-frequency) warmers Risk Level: ECRI Recommended. Types of heat exchangers include countercurrent fluid flow. Hospitals should replace such units with units equipped with alarms. assess- 016703 445-0595 A NONPROFIT AGENCY 5200 Butler Pike. Regulated water bath units typically consist of a disposable bag or coiled tubing immersed in a controlled temperature bath. Manufacturers should provide fluid output temperature data as a function of flow rate through a disposable set. microwave. Countercurrent devices pump heated water around the blood or solution in a direction opposite to its flow. or tubing set positioned against one or two heated metal surfaces. Should a temperature controller malfunction and allow the blood to overheat. Clinicians use such information in considering the actual contribution of a blood/solution warmer to patient thermoregulation. Although not required as a routine inspection procedure. some units lack them. Plymouth Meeting. Forced air units utilize convective warming by pumping heated air around a disposable tubing set.e.org . such as during massive (generally accepted to be five units or more) and/or rapid transfusion. hours hours Overview Blood/solution warmers are typically categorized by the method of in-line heat transfer they use to warm incoming solutions. anesthesia departments. Medium. solution warmers Commonly Used In: Operating rooms. PA 19462-1298. dry heat. blood banks Scope: Applies to all types of warmers that heat blood or solutions in-line as they pass from the fluid bag or infusion device to the patient. Microwave devices control blood or solution temperature through the use of noninvasive radiometric sensing. In these applications. Blood/Solution [10-447] Also Called: Blood warmers.Procedure/Checklist 445-0595 Blood/Solution Warmers Used For: Warmers.. Only under certain circumstances. critical care areas. allowing immediate power adjustment. periodic inspection of these units is particularly important to detect a malfunction likely to escape the user’s attention. Hospital Assessment. forced air. and regulated water bath technologies. effective blood/solution warmer operation is crucial. emergency departments. Blood/solution warmers are generally used in the operating room by the anesthesia staff. Thus. does not apply to unregulated water bath warmers (i. damaged or lysed red blood cells can be delivered to the patient. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. pouch. Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . . fluid warmers. Dry heat warmers use a disposable cassette. Failure of the heater to adequately warm blood could significantly lower body temperature and further compromise the patient. Clinicians disagree on when a blood/solution warmer should be used for patient thermoregulation.

2). >0. Remove any corrosion. check the service manual for correct thermometer or temperature probe placement and for allowable differences between measured and expected readings. also see “IPM Safety. Qualitative tests 1. unit from use.1 Chassis/Housing. .0 L) filled with refrigerated (4° to 6°C) saline Procedure Before beginning an inspection.10 or 2. Be sure to remove the compound as soon as measurements are completed. these options may not correctly reflect the actual heat exchanger temperature. Check that all doors. hinges. Data from this testing should be used in evaluating a unit for purchase. be sure that you understand how to operate the equipment. seek qualified help when performing this test. Special precautions Caution: Treat blood warmers as contaminated devices. Test apparatus and supplies Ground resistance ohmmeter Leakage current meter or electrical safety analyzer A mercury-in-glass calibration thermometer or electronic thermometer accurate to at least ±0.g. this may be due to test error or subtle differences in test methods.Inspection and Preventive Maintenance System ment of this performance characteristic is covered in an acceptance test (Item 4.3) to help ensure that the device has been correctly returned to its proper operating condition. for some units.5 to 1. Many warmers have special temperature measurement ports or accessories to assist biomedical personnel in determining heat exchanger temperature and alarm settings.11) after the temperature protection test (Item 2. However. and closure mechanisms work properly. bolts. or fungal buildup that may interfere with the temperature-sensing mechanism or heating of fluid in the disposable set.2°C over the range of 30° to 45°C Blood/solution warmer disposable set Wire or jumper leads Silicone heat sink compound or other thermally conductive medium (use on thermometer or temperature probe for better contact with heat exchanger in dry heat warmers) Hot (50° to 60°C) and room temperature water General-purpose infusion pump and infusion set Fluid container (0. When using these options during quantitative inspections to determine display accuracy and alarm settings. and other mechanisms for cracks and a secure fit.” behind the Guidance Tab of this binder. for infection control guidelines. Contact the manufacturer to determine whether such a difference (e. Return the unit to its normal operating condition immediately after completing the test.. that necessary assembly hardware is present and tight. 13:191-219. do not immediately remove the 1. and that there are no signs of spilled liquids or other serious abuse. and the measurements obtained by these methods will not necessarily agree with the unit’s displayed temperatures. Perform the operating temperature test (Item 2. where appropriate. 1984 Jul. Examine mounting clamps. Personnel responsible for inspecting blood/solution warmers must recognize their own limitations and. Citations from Health Devices Blood warmers [Evaluation]. All Rights Reserved. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Examine the exterior of the unit for cleanliness and general physical condition. carefully read this procedure and the manufacturer’s instruction and service manuals.5°C beyond service manual limits) is acceptable. however. Verify that a water bath warmer is 1. and the alarm capabilities. Use a silicone heat sink compound to improve the contact between the thermometer or temperature probe and the measured surface. Be sure that plastic housings are intact and are not cracked. We hesitate to recommend such action as part of a routine inspection procedure because unskilled personnel may inadvertently damage the unit. there may be no other way to determine whether the backup thermostat or overtemperature alarms are functional. even when properly used. Examine the interior surfaces where the disposable set will contact the heat exchange medium. temporarily bypassing the primary thermostat or similar control is the only way to determine whether backup or safety thermostats are functioning properly. Testing alarms and thermostatic settings may require disassembly of the unit and temporary modification of the wiring. debris.2 2 Inspection and Preventive Maintenance System ©1995 ECRI. Unfortunately. If you find a slightly larger difference than expected between your measurements and the temperature values provided by the manufacturer. the significance of each control and indicator. IV Pole Mount. Follow manufacturer-recommended decontamination procedures.

measure and record the resistance between the grounding pin of the power cord and exposed bare (not painted or anodized) metal on the chassis.7 1. labels. If the unit has an indicator light to show that the heater is operating. make sure that the line cord is long enough to preclude the need for an extension cord. from fingernails. but the overtemperature alarm can be easily triggered by filling the well with hot water (50° to 60°C). open the plug and inspect it fully. 1. If the heater component is readily available for visual inspection without disassembly. operate the warmer. 1. circulate hot water (50° to 60°C) through an installed disposable set. Be sure to wire a new power cord or plug with the correct polarity.. If damaged. pens).13 Controls/Switches. 1. Check for loose or missing pins. Attempt to wiggle the blades and determine whether they are secure. 1. blocked channels. Check for fluid infiltration in the plug. check its value and type (as well as those of any spares provided) against that marked on the chassis or in the instruction manual. or missing guides that may hinder placement of the disposable set. Examine all controls and switches for physical condition. secure mounting.4 1. Strain Reliefs. Operate the device to activate any audible signals.Blood/Solution Warmers reasonably stable when filled with water and mounted on the IV pole. If the warmer has a switch-type circuit breaker. Examine the AC power plug for damage. electrical safety analyzer. and ensure operation of the high-temperature alarm. overtemperature alarms.5 1.14 Heater(s)..3 Base Supports. Otherwise. We recommend a maximum of 0.24 Alignment Features for Disposable Sets. Examine the strain reliefs at both ends of the line cord. each control and switch performs its proper function. Shake the plug and listen for rattles that could indicate loose screws. check for proper alignment.g. 1. Line Cord. 1. cut out the defective portion. Confirm that the grid is in place and fits properly.6 1. Confirm the adequacy of alarm volume. deteriorated insulation). Circuit Breaker/Fuse. If the switch has a protective boot to guard against fluid infiltration. Inspect its sheath or surface for corrosion and mechanical integrity.20 Alarms. If so equipped. examine its physical condition (e.g. actuate this feature. Using an ohmmeter. During the course of the inspection. Many units provide some form of protection or grid to isolate the disposable set from the temperature sensor and/or heaters. 1. check that all rubber feet or other supports are securely in place. AC Plug. meters. If any damage is suspected. corrosion of its sheath. 1. and visual displays on the unit. If the warmer is protected by a fuse. or multimeter with good resolution of fractional ohms.21 Audible Signals. replace the entire cord or. if the damage is near one end. conversion charts. be sure to check that 2. Check that all necessary placards. check that it functions normally. position the disposable set and check that it is secure. The temperature sensor of a water bath unit may be located at the base of the water well. indicators.. Quantitative tests 2.11 Temperature Sensor (water bath units). and instruction cards are present and legible. 1.22 Labeling. confirm the operation of all lights. check that it moves freely. Operate the warmer to ensure that it does heat up and that the display follows a reasonable pattern of increasing temperature. Using the manufacturer’s instructions.1 Grounding Resistance. 3 . Many warmers have an alarm-test feature that activates their audible and visual alarms.g. reset features) that may be located on the base of the warmer. After any modifications. Inspection and Preventive Maintenance System ©1995 ECRI. Replace the grid if it is excessively corroded. Be sure that all segments of a digital display function. make sure that the boot is intact and protects the switch. be sure that they hold the cord securely and that they have not become dislodged from the chassis of the unit. During the course of the inspection. as well as positive stopping. All Rights Reserved. Inspect the cord for signs of damage.5 Ω. Where a control should operate against fixed-limit stops. If the warmer has a freestanding capability.18 Indicators/Displays. Check membrane switches for membrane damage (e. Remount or reglue any loose supports to ensure stability and adequate clearance for any components (e. Most water bath units do not have an alarm-test feature. and verify that the alarm activates and that the heater cycles off. and correct motion. gauges.

Use refrigerated (4° to 6°C) saline and maintain a flow of 500 mL/hr through the unit with an infusion pump. Therefore.11 Temperature Controller Performance. using any special adapters or ports designated for this purpose but insulated from the disposable set. compare the temperature displayed on the warmer with the thermometer at three separate points.) Position the temperature probe against or within the heat exchanger. (Applying power to some warmers when they lack a fluid flow through the unit’s disposable set may result in temperature overshoot and alarms that make assessing temperature sensor accuracy difficult. measure the actual heat exchanger temperature in several locations. If the probe has been successfully insulated from sensing the temperature of the cold fluid. All Rights Reserved. if necessary. and compare probe tempera- 2.) To determine display accuracy and temperature control. including on (while the heater cycles on and off) and off. first bypass the primary temperature control in the warmer (by shorting or opening it. it is necessary to measure only the heat exchanger temperature and compare it with the displayed temperature to ascertain proper functioning of the display temperature sensors. 2. (Remember to remove this compound and thermometer or temperature probe from the unit when finished.3 4 Inspection and Preventive Maintenance System ©1995 ECRI. The difference between the values for alarm set points and backup control as given by the manufacturer and those observed on the blood warmer temperature display should not exceed 0. obtain schematics and/or instructions to bypass the primary temperature control (see Special Precautions). . If. Determine the warmer’s various means of protection against overheating blood. Most temperature displays on blood warmers indicate heat exchanger temperature. as appropriate) and turn on the warmer so that the heater is controlled by the backup mechanism.5°C during steady state. Observe the unit for 5 min at steady state for proper maintenance of heat exchanger temperature. check that the unit is not alarming at a point different from the point observed in acceptance testing. If there are no procedures available. Follow the manufacturer’s recommended procedure for setting up the blood/solution warmer. the display and the heat exchanger temperature measurements should be within 1. In these cases. (This procedure need not be followed if Item 2. you find it necessary to establish a cold fluid flow through the disposable set before proceeding. If any recalibration is carried out involving sealed potentiometer or thermostat screws. Turn the unit on and compare the unit’s displayed temperature with the probe temperature(s) as the unit heats up and reaches a steady state. and record the maximum leakage current.5°C. During heat exchanger warm-up. Caution: Remove any bypasses installed for this test.0°C. The difference may be greater for some units with alarms and backup control based on a thermostat with a lag. use a silicone heat sink compound to establish better thermal contact. after reading the service manual. If the manufacturer has provided a detailed method by which backup controllers and alarms can be tested. position probes at three separate points within the heat exchanger and. Allow the warmer to stabilize for 5 min.0°C during warm-up and within 0. in most units. With the thermometer or temperature probe in place within the heat exchanger. Operate the device in all normal modes.2 Leakage Current. Leakage current should not exceed 300 µA. At no time should heat exchanger temperatures exceed 42°C.) The heat exchanger should be at room temperature before proceeding. reseal them. Allow a total of 15 to 20 min to observe temperatures. If possible.10 can be successfully used to determine accuracy and temperature control. because some warmers require 10 to 12 min to warm up and reach a stable heat exchanger temperature. When reassembling the unit. confirm that alarms go off at intended set points and that power to the heater is cut off at the intended settings. and ensure that it does not exceed 42°C upon activation of the alarm.10 Display Accuracy and Temperature Control. Otherwise. These temperatures should be within 1.Inspection and Preventive Maintenance System 2. reseal the back or bottom plates or panels into place with silicone compound to prevent fluid infiltration. position the thermometer or temperature probe against or within the unit’s heat exchange medium (some units require special accessories or have built-in ports for this purpose).11 to determine display accuracy and temperature control. 2. follow this procedure. High-Temperature Protection. not the exiting temperature of blood or fluid. Measure chassis leakage current to ground with correct and reversed polarity wiring and with the grounding conductor temporarily opened. perform Item 2.

e. perform the following tests. conforms to values specified by the manufacturer. The interior of water bath units should be rinsed and dried after each use.5°C. Ideally. and allow a drip flow through the warmer. All Rights Reserved. Check that the operating range of the warmer. Use a thermometer or temperature probe to measure the outflow temperature of refrigerated (4° to 6°C) saline at various flow rates corresponding to intended clinical applications or the manufacturer’s recommendations for use. Measure the patient lead leakage current from a steel-hub hypodermic needle on the distal connector of the administration set to ground with correct polarity but with an open grounding pin. but may be particularly useful in evaluating a unit for purchase.) To assess the warmer’s heating capability. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. Clean debris from door hinges. 3. If the unit’s heat exchanger exceeds 42°C. Before returning to use Verify that any control circuits that were bypassed or deactivated for testing purposes have been returned to their normal operating conditions. Record all output fluid temperatures and the corresponding flows for future reference. Prime the disposable set with saline. 3.3 4. Patient lead leakage current should not exceed 100 µA. the discrepancy should be within 0. It can be used to provide fluid output temperature data as a function of fluid flow.2 Fluid Temperature.. 4. the unit should deliver fluids at 37° to 42°C at the highest flow setting that clinicians expect to use with this unit.1 Patient Lead Leakage Current. Inspection and Preventive Maintenance System ©1995 ECRI. 18° to 22°C) for future comparison of results. also measure the output fluid temperature as close to the heat exchanger as possible to verify that it does not exceed 42°C. Fluid temperature measurement should be at the end of the manufacturer’s disposable set or at the outlet of any extension tubing required to accurately simulate a clinical setting. select its maximum temperature setting and allow the unit to stabilize. including on (while the heater cycles on and off) and off. as determined from the display. Monitor and record ambient temperature (i. In addition.Blood/Solution Warmers ture with the displayed temperature.1 Clean the unit’s exterior and heating plates or bath. Preventive maintenance 3. (This procedure is optional. 4. Calibrate if needed. Operate the device in all modes. as well. 5 .

. and airway pressure. the devices alert physicians to inadequate ventilation (i. . prehospital use.Procedure/Checklist 450-0595 Capnometers and Multiple Medical Gas Monitors Used For: Carbon Dioxide Monitors.g. capnometers) use infrared spectrometry to measure CO2 concentrations. respiration rate. CO2 monitors are used primarily in the operating room to monitor patients during anesthesia. These units are used clinically to detect esophageal intubation.org . and assess respiration. Respired-gas MMGMs are used in critical care areas to monitor ventilation of mechanically ventilated patients and to 084776 450-0595 A NONPROFIT AGENCY 5200 Butler Pike.. and airway leaks. crash carts) and patient transport. Hospital Assessment. critical care units. Exhaled Gas [16-938] Multiple Medical Gas Monitors [17-443] Multiple Medical Gas Monitors. Respired/Anesthetic [17-445] Also Called: Capnographs. which are battery powered and lightweight. and an MMGM’s cost is lower than the combined cost of the monitors it replaces. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri.g. Information provided by MMGMs is easier to review. Respired [17-444] Multiple Medical Gas Monitors. CO2 monitoring can also detect ventilator failure and the inadvertent placement of the endotracheal tube in the esophagus. minute volume that is too low). Multiple medical gas monitors (MMGMs) incorporate monitoring of several gases.e.. such as pulse oximetry or airway pressure and minute and tidal volume monitoring (inspection of the pulse oximetry capability is covered in Pulse Oximeters Procedure/Checklist 451) Risk Level: ECRI Recommended. end-tidal CO2 monitors Commonly Used In: Operating rooms. Plymouth Meeting. and of the patient’s ability to breathe spontaneously after ventilator support is discontinued. Two types of MMGMs are available. patient circuit disconnections. of bronchodilator treatment effectiveness. Overview Carbon dioxide (CO2) monitors (e. including CO2. emergency departments. PA 19462-1298. Interest in applying CO2 monitoring to intensive care mechanical ventilation is increasing. are suitable for emergency medicine (e. High. portable units may be used by EMS Scope: Applies to monitors that analyze concentrations of respired and/or anesthetic gases. along with other parameters such as pulse oximetry. primarily to evaluate the effects of changing ventilation modes. Capnometers. monitor for and detect complete loss of ventilation or apnea. and that may also be equipped with additional capabilities. emergency departments. Currently. Type Major Minor ECRI-Recommended Interval 12 months* NA Interval Used By Hospital months months Time Required . hours hours * Some manufacturers may recommend calibration at a semiannual or monthly interval.

If any damage is suspected.) Marquette Series 7000 capnometer [Update]. Examine these for general condition.10 Fittings/Connectors. verify that an adequate supply is available.9 Special precautions Exposure to waste anesthetic gas can be hazardous. Be sure that they hold the cord securely. If the line cord is detachable (by the user). Inspect any cables and their strain reliefs for general condition.g. 1987 Jun. examine the condition of the 1. the significance of each control and indicator.) Multiple medical gas monitors.12 Filters.1 or 3. Hewlett-Packard Model 47210A capnometers [User Experience NetworkTM]. If any settings appear inordinate (e. Check the condition of all gas (air) filters. If damaged. a gain control at 1. Before changing any controls or alarm limits.. All Rights Reserved.13 Controls/Switches. 1987 Feb. and the alarm capabilities. Be sure that plastic housings are intact.2 2 Inspection and Preventive Maintenance System ©1995 ECRI.7 1. and indicate this on Line 3. 16:219. (See also 1986 Nov.Inspection and Preventive Maintenance System assess the adequacy of their parenteral nutrient intake by tracking their metabolic rate. 1. Verify that sensors and sampling lines are firmly gripped in their appropriate connectors. Carefully examine cables to detect breaks in the insulation and to ensure that they are gripped securely in the connectors at each end to prevent rotation or other strain. (See Health Devices 1993 May-Jun. Verify that there are no intermittent faults by flexing electrical cables near each end and looking for erratic operation or by using an ohmmeter.5 Test apparatus and supplies Leakage current meter or electrical safety analyzer Ground resistance ohmmeter Calibration gas Stopwatch or watch with a second hand Flowmeter (0 to 1 L/min air) 1.11 Sensors/Sampling Lines. Gases containing inhalated anesthetics (e.g.4 of the inspection form. Electrical contact pins or surfaces should be straight. be sure that you understand how to operate the equipment. halogenated agents) should be scavenged.4 AC Plug. that all hardware is present and tight. or if the damage is near one end. and that there are no signs of spilled liquids or other serious abuse. 1986 Sep-Oct. MMGMs that monitor respired and anesthetic gases are intended for use in the OR and can indicate malfunctions or disconnections in the gas delivery system and abnormalities in the uptake. carefully read this procedure and the manufacturer’s instruction and service manuals. Be sure to wire a new power cord or plug with the correct polarity. replace the entire cord. 16:56. Qualitative tests 1. Strain Reliefs. Cables. check that it moves freely. check their positions. .6 1. mount. 1990 Feb. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. If the device is mounted on a stand or cart. Examine the strain reliefs at both ends of the line cord. 1. for general condition. If the device is protected by an external fuse. Line Cord. Examine the exterior of the unit for cleanliness and general physical condition. cut out the defective portion. 15:255-85. 20:43-54. as well as electrical cable connectors. 1. If disposable sampling lines are used. Examine the AC power plug for damage. clean. and delivery of gases. 22:301-3. 16:251. N2O.1 Chassis/Housing. 15:316. If it is attached to a wall or rests on a shelf. check the security of this attachment. check its value and type against that marked on the chassis. Shake the plug and listen for rattles that could indicate loose screws. Mount/Fasteners.. and ensure that a spare is provided. Inspect the cord for signs of damage.) Circuit Breaker/Fuse. If the device has a switchtype circuit breaker. removal. Fittings should be tight and should not leak. 1. Citations from Health Devices Carbon dioxide monitors [Evaluation]. Clean or replace if appropriate. respired/anesthetic [Evaluation]. (See also 1987 Jul. and bright. 1. Examine gas sample inlet and exhaust port connectors. affix the cord to the unit so that it cannot be removed by the operator. Procedure Before beginning an inspection. 1. Attempt to wiggle the blades to check that they are secure. open the plug and inspect it.

Other alarms. 2. be sure to check that each control and switch performs its proper function.18 Indicators/Displays. When it is necessary to replace a battery. and blow several breaths into the adapter before stopping. Check operation of battery-operated power-loss alarms. Induce each alarm condition with each procedure below. and verify that the unit activates an audible and visual alarm for each alarm limit that has been exceeded. measure and record the resistance between the grounding pin Inspection and Preventive Maintenance System ©1995 ECRI. alert clinical staff to the importance of keeping alarms at the appropriate level. 60 Hz noise). and visual displays on the unit and charger (if so equipped). and note this on Lines 3. from fingernails. secure mounting.g. label it with the date. (However. Where a control should operate against fixed-limit stops.e. 1. If the unit indicates any other alarm condition. Examine all controls and switches for physical condition. Inspect the physical condition of batteries and battery connectors. as well as the operation of a volume control. Be sure that all segments of a digital display function and that the unit displays waveforms and trending information.22 Labeling. and correct motion. if so equipped. Verify that the monitor displays a respiration rate and that the CO2 waveform indicates the breaths. Verify that the calibration function operates.. meters.Capnometers and Multiple Medical Gas Monitors maximum. if so equipped. if readily accessible.. It may not be possible to check out all alarms at this time. Check the physical condition and proper operation of the pump. consider the possibility of inappropriate clinical use or of incipient device failure. confirm that it does in fact charge the battery. If the unit has an alarm-silence feature. labels. Occlusion alarm.g. when applicable.. Verify that visual and audible high-concentration and low-concentration alarms activate. Using an ohmmeter. alarm limits at the ends of their range). Operate the device to activate any audible signals.23 Accessories. If audible alarms have been silenced or the volume set too low. gauges. Clean and lubricate if required. Deliver the calibration gas to the monitor. induce the alarm. Verify that reset silenced alarms reactivate within the manufacturer’s specified time.19 User Calibration. distortion. and verify that the alarm condition is indicated by the unit. Operate the unit on battery power for several minutes to check that the battery is charged and can hold a charge. Check that control knobs have not slipped on their shafts.1 and 3. 1..15 Pump. 1. Connect a clean airway adapter and sampling line to the unit. Check the condition of the battery charger. or multimeter with good resolution of fractional ohms. indicators.1 Grounding Resistance. Set the gas alarm limits so that the concentration in the calibration gas will exceed the limits (i. and check its quality (e. Confirm the presence and condition of breathing circuit adapters and sampling lines and.) 1. do not check these items until all necessary cleaning and lubrication are completed. During the course of the inspection. and instruction cards are present and legible. Check membrane switches for membrane damage (e. Confirm appropriate volume. Observe a signal on a CRT display. Be sure that the battery is recharged or charging when the inspection is complete. 1. confirm the operation of all lights. (The inspection can be carried out on battery power to help confirm adequate battery capacity. and observe the alarm. focus. if present.20 Alarms. water traps and filters. check for proper alignment.21 Audible Signals. conversion charts. Quantitative tests 2. 3 . During the course of the inspection.2 of the inspection form. set the high-concentration alarm limits below the calibration gas concentrations and the lowconcentration alarm limits above the calibration gas concentrations).e. check the method of reset (i. electrical safety analyzer. Gas concentration alarms. Block the sampling line. Check that all necessary placards. All Rights Reserved.) Check battery condition by activating the battery test function or measuring the output voltage.17 Battery/Charger. manual or automatic) against the manufacturer’s specifications. as well as positive stopping. 1. Record the settings of those controls that should be returned to their original positions following the inspection. since some may require abnormal operating conditions that will be simulated later in this procedure. and to the extent possible. 1. pens). 1.

standby. calibrate the unit. Other controls should be in their normal pre-use positions. and record the maximum leakage current.Inspection and Preventive Maintenance System of the power cord and exposed (unpainted and not anodized) metal on the chassis. Select an agent on the monitor. indicate “DI” instead of the ground resistance value. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. and record the delivered and displayed O2 concentrations on the inspection form. We recommend a maximum of 0. The display should be within 0. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off. whichever is greater. Note: Vol% refers to the absolute value versus % of value. Operate the device in all normal modes. Chassis leakage current to ground should not exceed 300 µA. Before returning to use Make sure that all controls are set properly. 2. of the delivered concentration. If the gas concentration display is inaccurate.2 Leakage Current. 2. If the gas concentration display is inaccurate.5 Ω. water traps. .7 3.4 vol% (±3 mm Hg) or within 10%. If the system is modular or composed of separate components. whichever is greater. and off. 2. whichever is greater.3 3. The display should be within 5 vol% or within 10%. Deliver calibration gas containing O2 to the unit. Deliver calibration gas containing CO2 to the unit. Lubricate pump if required. If the device is double insulated. Calibrate the unit per the manufacturer’s instructions. The display should be within 2 vol% or within 5%.6 Nitrous Oxide (N2O) Concentration Display Accuracy.25 vol% of the delivered concentration. and record the delivered and displayed N2O concentrations on the inspection form. Preventive maintenance 3.4 Clean if needed. Calibrate if required per the manufacturer’s instructions. and record the delivered and displayed CO2 concentrations on the inspection form. including on. and verify the sampling flow at the highest flow setting. Record the replacement date on the O2 cell label before installing it in the monitor. the flow should be within 20% of the flow setting. including the internal sampling line if specified by the manufacturer. The display should be within 0. This includes other equipment that is plugged into the primary device’s accessory receptacles. Deliver calibration gas containing N2O to the unit. 2. Set alarms loud enough to alert personnel in the area in which the device will be used. For example. air filters. If the gas concentration display is inaccurate. verify grounding of the mainframe and each module or component. and deliver calibration gas containing that agent to the unit. Halogenated Agent Concentration Display Accuracy. calibrate the unit. Replace O2 cell. Sampling Flow Accuracy. if needed. 2. All Rights Reserved.2 3. calibrate the unit. Recharge battery-powered devices or equip them with fresh batteries if needed. calibrate the unit. and the CO2 absorber. as well as equipment plugged into a multiple-outlet strip (“Waber strip”) so that all are grounded through a single line or extension cord. a 5% (of value) error at 40 vol% of O2 is the same as a 2 vol% error. Attach a flowmeter to the sampling inlet. 4. if the flow is inaccurate. The flow rate should be within the manufacturer’s specified range.1 3. If the manufacturer’s information is unavailable.4 Carbon Dioxide (CO2) Concentration Display Accuracy. of the delivered concentration. of the delivered concentration. grounding resistance need not be measured.5 4 Inspection and Preventive Maintenance System ©1995 ECRI.3 Oxygen (O2) Concentration Display Accuracy. If the gas concentration display is inaccurate. Record the delivered and displayed agent concentrations on the inspection form. 2.

which in turn vaporizes the tissue. and dermatology procedures. other infrared lasers. at the same point) with the CO2 laser beam. 042241 446-0595 A NONPROFIT AGENCY 5200 Butler Pike. with mirrors in the knuckles to redirect the energy down the next tube. water. blood). This arm contains a series of hollow tubes connected by knuckles at the ends to allow 360° rotation. Some newer lasers have orange or yellow aiming beams.g. Like most lasers. emit mid-infrared energy at 10. CO2 surgical lasers affect tissue by focusing invisible. .and high-power CO2 surgical lasers that are typically used for general surgery. or damage to the laser system. CO2 lasers are somewhat inefficient in converting electrical energy from their standard 115 VAC source into laser energy of 0 to 100 W. Because the mid-infrared energy emitted by the CO2 laser is invisible. General-purpose CO2 surgical lasers have a flowinggas laser tube or a sealed or semisealed gas tube. gynecology lasers. a second. This energy heats the water in the cells to the boiling point. these attachments focus the energy into a small spot size at a known working distance. podiatry. This minimizes the need for frequent additional periodic testing. surgical lasers.Procedure/Checklist 446-0595 Carbon Dioxide Surgical Lasers Used For: Lasers. many of the tests listed herein can be used or modified for these other lasers Risk Level: ECRI Recommended. High. Failure of a CO2 surgical laser can cause patient or staff injury. Surgical. Carbon Dioxide [16-942] Also Called: CO2 lasers. A laser handpiece or a laser micromanipulator (used to interface the laser with the surgical microscope) is usually attached to the last tube of the articulating arm. does not apply to handheld CO2 lasers. ENT lasers. Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . neurosurgical lasers Commonly Used In: Operating rooms. far-infrared energy at a sufficient power density to cause vaporization. neurosurgery.. short procedure areas.e. and provide sufficient power output to vaporize tissue. an abrupt interruption of a surgical procedure.600 nm. ENT. however. PA 19462-1298. CO2 surgical lasers must be meticulously maintained to ensure proper and safe operation. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. physicians’ offices Scope: Applies to general-purpose CO2 surgical lasers that include an articulating arm. Nd:YAG and argon lasers. and ophthalmic lasers. CO2 surgical lasers are considered good cutting instruments. also applies to low. Plymouth Meeting. It cannot be transmitted through liquids (e. The wavelength is readily absorbed by water and has little scatter in tissue. hours hours Overview CO2 lasers are normally checked before each use by the laser’s power-on self-test and by user examination of the aiming beam and calibration of the system with the delivery system to be used. Energy leaving the laser tube through a partially reflecting mirror is typically directed into an articulating arm.org . gynecology. nontherapeutic aiming helium-neon (He-Ne) laser emitting visible red light simultaneously traverses the articulating arm and is focused coincident (i. Hospital Assessment..

1984 Jun. Lack of pin-indexing on laser gas supplies [Hazard update]. thermal imaging plates. 1991 Jul-Aug. Do not switch it to the Operating mode until the procedure is about to begin and the laser and its delivery system are properly positioned.e. (Window covers are not necessary with carbon dioxide lasers. Do not use the laser in the presence of flammable anesthetics or other volatile substances or materials Citations from Health Devices Lasers in medicine: An introduction. 1984 Sep. Laser energy can cause serious injury. 16:216. or standing). 13:15178. at minimum. even a full room length or more away from the laser (and can harm tissue or burn material even at this distance). when kneeling. either an internal or external gas regulation system must be included.g. Lasers as investigational devices: Appendix A. wood tongue depressors may be an acceptable alternative) Laser radiometer (power meter) Laser safety signs Laser safety eyewear specifically designed for use with CO2 surgical lasers and of sufficient optical density to protect the wearer’s eyes from laser injury Vise with padded jaws or ring stand with padded clamp Outlet test fixture (optional) 2 Inspection and Preventive Maintenance System ©1995 ECRI. Flowing and semisealed lasers typically use a vacuum pump to maintain tube pressure. The laser should remain in the Off position when not in use. although most use a combination water/air cooling system. excess heat is generated in the laser tube. If the procedure must be interrupted. 1984 Jun. 1987 May. Lasers: Model policy and procedures statement: Appendix B. requiring a cooling system. Loose caster screws on Sharplan lasers. 13:167-9. Under some circumstances. All Rights Reserved.. Surgical lasers [Evaluation].Inspection and Preventive Maintenance System As a result. 13:291. Power requirements for Coherent Excelase 55 CO2 laser [User Experience NetworkTM].) Do not perform these procedures when a patient is present or when clinical staff is working. ≥1″ wide. 13:169-71. 1989 Oct. 1992 Feb. especially during procedures of recognized risk. 1987 Aug. Personnel who inspect or service lasers should receive special training from the manufacturer or from a qualified alternative training source. Lack of pin-indexing on laser gas supplies [Hazard]. A second person should be present. the beam may not diverge significantly. or firebrick Laser beam imaging media (e. Hence. WARNING: Laser safety eyewear may not protect the wearer from the aiming system light. high voltage (optional) Grounding strap (optional) Special precautions Inspecting and maintaining lasers is a dangerous as well as necessary process. 16:176. 18:365. Avoid placing the laser beam path at eye level (i.. about 3″ to 4″ long. Some CO2 lasers use air cooling. When in use. 21:79. 16:286. Insulating gloves. 1987 Jun. Area security and use of personnel protective devices and practices should be consistent with hospitalwide laser safety procedures and/or should be approved by the laser safety committee. Surgilase CO2 lasers [Hazard]. and do not aim the laser across a path that a person might normally use as a thoroughfare. Therefore. Wear appropriate laser safety eyewear at all times whenever the laser is in the Operating mode. Do not stare directly into the aiming system beam or the therapeutic laser beam. disconnect the laser from line voltage. post doors to the room with appropriate laser safety signs stating that the laser is in use and that it is unsafe to enter the room without authorization by the service person performing the procedure. to summon help in case of an accident. it should be in the Standby/Disabled mode. Sharplan 733 carbon dioxide surgical lasers [User Experience NetworkTM]. Furthermore. and remove the laser operation key and store it in a controlled location. . particularly when the internal interlock is overridden or in any other situation in which the energy does not diverge significantly over long distances. and far greater care is required than with most devices. 1984 Jun. Flowing-gas tube lasers require regulation of the pressure and flow of special gas mixtures. Test apparatus and supplies Leakage current meter or electrical safety analyzer Ground resistance ohmmeter Black Delrin block ≥1⁄2″ thick. even when wearing laser safety eyewear. sitting. 20:239-316. thermal imaging paper. exercise great care whenever a laser beam is accessible.

in good working order.1 Chassis/Housing. General. Be sure that all housings are intact and properly aligned.g. Capacitors may store charges long after the device has been disconnected from line voltage. and inform users of the importance of storing the key in a controlled location. and use insulated gloves for those procedures in which contact with a high-voltage source is possible (and the gloves are not otherwise contraindicated). in good condition. check mounts or holders for other devices (e. Qualitative tests 1. threads or quick-connect fitting) is in proper working order. and being used. perform tests with the unit turned off. Shutters.Carbon Dioxide Surgical Lasers (e. Verify that the key has not been left in the laser. Remove from the working area or cover with flame-resistant opaque material all reflective surfaces likely to be contacted by the laser beam. Ensure that the column can be adjusted through its full range. note this on Line 3. Some surgical lasers use high voltages (e..1) before any other item that requires operation of the laser. black Delrin) when the laser is to be activated.3 Casters/Brakes. preferably. Where possible. 1. If manual shutters for the aiming or therapeutic laser are accessible. ensure that they operate smoothly and correctly. and precautions needed to ensure safety and to avoid equipment damage... Ensure that the arm is properly counterbalanced and maintains its position without any motion after it has been moved and released.. Inspection and Preventive Maintenance System ©1995 ECRI. be sure that you understand how to operate the equipment. 1. carefully read this procedure and the manufacturer’s instruction and service manuals. disconnect the laser from line voltage before entering the laser cabinet. Be sure that all hardware (e. Procedure Before beginning an inspection..g. Examine the exterior of the articulating arm for cleanliness and general physical condition. alcohol) or in an oxygen-enriched atmosphere because of the serious risk of explosion and fire. Because of the presence of high voltage.) Examine any external gas tanks that may be in use with the laser. Check the operation of brakes and swivel locks. examine the condition of the mount. above 20 kV). or insulate high voltages carries the appropriate insulation rating (e. Check that the mounts securely contain the gas cylinders. laser gas tubing channels) is present. Whenever possible.. and ensure that they have been turned off after the last use.2 of the inspection form. 3 . external power meters. Be sure that mounts or holders intended to secure the articulating arm to the chassis (to protect the arm when the unit is not in use) are present. Ensure that equipment intended to be used to measure. If lubrication is required. that any retractable parts slide easily and lock in place if so constructed. Examine the distal end of the articulating arm to ensure that the mechanism (e. that assembly hardware is present and tight. a good ground must be present. footswitch). Verify that the casters roll and swivel freely. perform the Grounding Resistance Test (Item 2. Telescoping columns. Also. and avoid contact with any portion of the high-voltage circuit until you are certain that the charge has been drained. drain. A CO2 fire extinguisher should be readily available. Consult the manufacturer’s recommended procedures for servicing high-voltage laser circuits. Articulating arm. which can be lethal. When possible. Similarly. use a firebrick or other nonflammable material behind the target material (e.. If the device is mounted on a stand or a cart.g.g. and that there are no obvious signs of water or oil leakage.g. Ensure that each knuckle of the arm moves easily in each direction. Examine the exterior of the telescoping column for cleanliness and general physical condition. the significance of each control and indicator.g. 1. use a redundant ground strap if you must enter the laser cabinet. determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Examine the exterior of the unit for cleanliness and general physical condition. that there are no signs of spilled liquids or other evidence of abuse. In such instances. Verify that the mounting apparatus is secure and that all hardware is firmly in place. as well as to the hospital risk manager. (Remove it if it has. All Rights Reserved. Report any laser accident immediately to the laser safety officer or equivalent. Be sure to leave the shutter in the proper position for normal operation.g. 20 kV).2 Mounts/Holders. and firmly attached.

Cables. Clean or replace filters according to the manufacturer’s recommendations (e. that they have not become cracked and do not show other signs of significant abuse.10 Fittings/Connectors. check that it moves freely. secure mounting. Check the condition of all coolingsystem hoses and any other hoses or tubing the laser may have (e. Gas and liquid fittings should be tight and not leak. 1. and intended range of settings. from fingernails.9 1. and indicate this in the preventive maintenance section of the inspection form. Lasers that connect to the central piped medical gas system or to a freestanding medical gas system should have the matching DISS or quick-connect fitting for the gas that it is to be 4 Inspection and Preventive Maintenance System ©1995 ECRI. It is usually possible to feel the vibration caused by closure of the switch. If any position appears unusual. and listen for rattles that could indicate loose screws.. check for proper alignment. Verify that suitable connectors are supplied so that adapters are not required. Electrical contacts should be straight. as well as all electrical connectors.. Where a control should operate against fixed-limit stops. Examine all controls and switches for general physical condition. During the inspection. If the device has a switch-type circuit breaker. consider the possibility of inappropriate use or of incipient device failure. Tubes/Hoses.5 1. Examine the strain reliefs at both ends of the line cord.g. If you find such evidence. Check that they are of the correct type. cut out the defective portion. ensure that the cable and any connectors are in good condition. Some footswitches include two 1. replace the entire cord or. . that they are connected correctly and positioned so they will not leak. Examine the footswitch for general physical condition. Before moving any controls. and bright. Examine cables carefully to detect breaks in insulation and to ensure that they are gripped securely in the connectors at each end to prevent strain on the cable.g. check its value and type against what is marked on the chassis or noted in the instruction or service manual.13 Controls/Switches. and that they are secured adequately to any connectors. 1. open the plug and inspect it.g. replace if the pressure drop is >5 psi). secure mounting.8 1.12 Filters. If a control has fixed-limit stops. correct motion. notify users to avoid using tape and sharp instruments. Clean or replace air filters and radiators that are obviously dirty..6 General.Inspection and Preventive Maintenance System 1. Check that the internal switch is operating and that the footswitch does not stick in the On position. Line Cords. used with. Examine all gas and liquid fittings and connectors. kink. and correct motion. Examine all controls and switches for physical condition. drain. Shake the plug. Check membrane switches for tape residue and for membrane damage (e. Be sure that they grip the cord securely. or surgical instruments). for general physical condition. or be caught in moving parts.4 AC Plug/Receptacle. If other hospital equipment will be attached to the connector. Ensure that no pins are missing and that the keying and indexing for each gas to be used is correct. Be sure that plastic housings are intact. including evidence of spilled fluids. Be sure to wire a new power cord or plug with the correct polarity. gas). If you suspect damage. Examine the exterior of the control for cleanliness and general physical condition. even through a shoe. Check the condition of all liquid and air filters. During the course of the inspection. that assembly hardware is present and tight. be sure that each control and switch works properly. Remote.7 1. Footswitch. trail on the floor. Inspect line cords for signs of damage. check and record their positions. Footswitches for lasers include internal switches that activate according to the depth of pedal depression. Pin indexed gas connectors should be present. and that there are no signs of spilled fluids or other serious abuse. as well as positive stopping. Inspect all cables and their channels or strain reliefs for general physical condition. 1. Examine the AC power plug for damage. as well as positive stopping. All Rights Reserved. clean. Strain Reliefs. be sure to check that each control and switch performs properly. Wiggle the blades to determine if they are secure. be sure that the connectors match. If the remote control is attached by cable to the laser. Circuit Breakers/Fuses. pens. if the damage is very near one end. check for proper alignment. If the device is protected by an external fuse(s). If a cord is damaged. Ensure that a spare is provided or readily available.

check or replace the battery (periodic prophylactic battery replacement is often preferred to risking battery failure during use). laser emission.18 Indicators/Displays. and visual displays on the unit and the remote control.g.. Check for proper operation. be sure to test only those alarms that will not cause damage to the laser or present an unnecessary risk of laser beam exposure to yourself or bystanders. Check all fluid (e. Refill or change the fluid according to the manufacturer’s recommendations. 5 . (Do not disassemble major parts of the laser to test internal interlocks. and verify that it is correct.21 Audible Signals. Set up each accessory with the laser to ensure compatibility and proper functioning. note this in the preventive maintenance section of the form. Operate the device in a manner that will activate the self-check feature.17 Battery. Store some sample information. and verify that all visual and audible alarms activate according to the manufacturer’s documentation. check for internal wire breaks that might cause intermittent operation.23 Accessories. 1. Ensure that all segments of a digital display function. test this feature to be sure that it deactivates the laser and that the laser will subsequently restart. and verify that the signal can be heard in the environment in which the laser will be used. and note this in the preventive maintenance section of the form. If a door or window interlock is used. check to be sure that the laser activates consistently when the footswitch is depressed. If a feature to manually reset this information is available. Check to see that an instruction manual is kept with the laser or is readily available.20 Alarms/Interlocks. Be sure to check the interlocks in all locations where the laser is used. Operate the device to activate any audible signals (e. During the procedure. Ensure that the connector secures acceptably to the laser cabinet. pulse or accumulated energy counter).g. During the procedure. ensure that each display provides the information expected.) After deactivating the laser and reclosing the door or window. and instruction cards noted during acceptance testing (see Item 4. Confirm that strain reliefs are secure.3) are present and legible. 1. Examine the male and female connectors for attaching the footswitch to the laser cabinet to be sure that no pins are bent and that no other damage is present. operate the laser in a manner that will activate each audible and visual alarm. and using an ohmmeter. Note any messages displayed during the power-on self-test. 1. Verify that all necessary accessories are available and in good physical condition. setting change).) If the laser is equipped with an emergency “kill” switch. Check that all placards. check to be sure that the laser activates consistently when the footswitch is depressed.g. All Rights Reserved. 1. settings. Clean any obvious dust from these components. if present.Carbon Dioxide Surgical Lasers internal switches. in this case. gauges. verify proper operation of all lights.15 Motors/Pumps/Fans/Compressors.22 Labeling. If the remote control is battery powered. If lubrication is required. coolant) levels. During the course of the inspection. 1. check to be sure that the laser will restart. When it is necessary to replace a battery. If primary and remote-control indicators and displays can be used at the same time or if control can be switched from one to the other during a procedure.. ensure that it properly deactivates the laser. Flex the cable at the entry to the switch. 1. If display screens or digital displays are provided for user prompts or for viewing accumulated information (e. Checking all accessories during a single inspection and preventive maintenance procedure is unnecessary as long as accessories are routinely checked by the person(s) respon- Inspection and Preventive Maintenance System ©1995 ECRI. verify the operation of both.g. indicators. Ensure that user prompts occur in the proper sequence. 1. (For some lasers. If no self-check feature is present. 1. labels. Check the physical condition and proper operation of these components. label it with the date. operate the laser in a way that will verify that the same information (e. meters.16 Fluid Levels. ensure that it works. General. the function of the interlocks can be checked using an ohmmeter.. displays) is indicated on both controls..

All Rights Reserved. handle lenses by the edges only.25 Gas Regulators. Avoid exposing the lenses to water.) Leakage Current. and verify that it produces a round. electrical safety analyzer. Similarly. be sure that it turns easily and does not slip. and do not touch the reflecting lenses in the body. or snaprings. do not hold it by the joystick. .g. 1. If a zoom focus feature is present. Inspect micromanipulators provided by both the laser manufacturer and the laser accessory manufacturers. accessory outlet. Check that the intensity control. Examine the gas regulators (if external to the cabinet) for cleanliness and general physical condition. Do not touch the lens surface. Consult the manufacturer’s recommendations for the procedures and cleaning agents to use to clean reflecting surfaces and lenses. Connect the micromanipulator to the articulating arm to check for a secure connection. and ensure that it fits snugly. does change the brightness of the aiming beam. lenses) for cleanliness and general physical condition. Ensure that major subcomponents of the handpiece..1 Grounding Resistance. Ensure that the mechanisms used to connect the handpiece(s) to the articulating arm are in good working order and that they reliably secure each handpiece to the arm. uniformly bright spot with no halo. 2.5 Ω. since most CO2 lens materials are soluble in water. many of the accessories are sterile and would require resterilization before use. Be sure to handle it by the main body. Examine each handpiece component (e. ensure that it is firmly attached and properly oriented. ground pins. Be sure to check with the person responsible for scheduling the use of the laser before beginning the procedure. If several color choices are available for the aiming beam. verify that the spot size changes as expected and still remains uniform. Handpieces.2 6 Inspection and Preventive Maintenance System ©1995 ECRI. tips. Examine each objective lens to ensure that it is intact and clean. Be sure that a key or wrench to facilitate changing the gas supply is with the unit or readily accessible. Ensure that the reflecting lenses are intact and clean. since most CO2 lens materials are soluble in water. Use an ohmmeter. We recommend a maximum of 0. 2. If a finger rest is present. Ensure that the gauges on the regulators are not broken. verify that each color is present and working properly.) If lenses are detachable. While performing the preventive maintenance items. grounding is not required. be sure not to touch the lens surface. bolts. Connect the micromanipulator to the microscope to check for a secure connection. In addition. and footswitch. Verify that the correct gas is attached to each regulator. Microscope micromanipulator. WARNING: Do not reverse power conductors for this or any other test. ensure that the regulator and the gauge operate as expected. Examine the microscope micromanipulator for cleanliness and general physical condition. For handpieces that provide adjustable spot sizes. Quantitative tests 2.Inspection and Preventive Maintenance System sible for laser setup and operation. Examine individually only those components that are intended for removal during normal use and storage. Inspect the mechanism used to attach the micromanipulator to the microscope to ensure that all parts are present and that it is in good working order. Carefully insert each lens into the micromanipulator. Examine the joystick to ensure that it is firmly attached and that it freely moves the reflecting lens. are secure. making the laser potentially unavailable. (If the footswitch is of low voltage. body. Avoid exposing the lenses to water.24 Aiming Beam. if present. or multimeter with good resolution of fractional ohms to measure and record the resistance between the grounding pin on the power cord and exposed (unpainted and not anodized) metal on the chassis. Consult the manufacturer’s recommendations for the procedures and cleaning agents to use to clean lenses. Consult the manufacturer’s recommendations for the procedures and cleaning agents to use to clean the objective lenses. Inspect the mechanism used to attach the micromanipulator to the articulating arm to ensure that it is in good working order. Activate the aiming beam (without the therapeutic beam). 1. when assembled. Improper attachment of conductors may damage the laser. (Do not remove other parts that are press-fit or attached by screws. check pulsing controls to verify that the aiming beam can be pulsed.

test the laser to be sure that the correct power is repeatedly delivered over the correct time period. median. 2. except continuous. if adjustable. handpiece. use the following alternative test method. The burn and the circled area should overlap (although not necessarily be of the same size).6 Figure 1. Verify that the beam turns off when the footswitch is released. All Rights Reserved. 1). and verify that the Repeat Pulse feature operates as expected by moving the target material slightly between each pulse. since this will be more sensitive to misalignment and distortion problems. If the number or duration between repeat pulses is adjustable.5 sec. 2. Set the output time for about 5 sec. If the unit includes a Repeat Pulse feature. If you are using such a power meter.. However. Some laser power meters can measure pulse duration. or micromanipulator attached. Adjust the exposure setting in increments of 0. test the laser at each setting. if the laser power meter does not measure pulse duration.) First check beam coincidence and pattern with the microscope manipulator. Circle the spot created by the aiming laser. and compare the burn created by the therapeutic laser on the tongue depressor with the circled area.3 Exposure Duration. and maximum Repeat Pulse settings. use the following less preferable alternative. 2. and developed a series of burns. ensure that appropriate grounding is present. These two lasers should create a spot at the same location.4 Repeat Pulse. Tongue depressor with laser burns produced during progressive exposure durations Inspection and Preventive Maintenance System ©1995 ECRI. Be extremely careful to keep hands out of the laser beam path. Compare the burns to verify that progressively larger burns occurred as the exposure duration increased (see Fig. Therapeutic and Aiming Beam Coincidence. Continue this process until you have tested all exposure settings. Carefully move the target material to expose a clean area. test this feature with the laser set at the minimum. Place and secure the laser handpiece with the aiming beam focused on the target material (e. If your laser power meter cannot be used for this test. maintaining the same distance. With the laser set to about 5 W and the exposure setting at its minimum duration. 2).Carbon Dioxide Surgical Lasers With the laser attached to a grounded powerdistribution system.1 sec or the next longest duration. measure the leakage current between the chassis and ground with the unit grounded and ungrounded. 7 . black Delrin. The leakage current on the chassis should not exceed 300 µA. activate the laser and create a burn. and release the footswitch after about 1 sec.1 sec exposure duration with the fiber. CO2 surgical lasers include a He-Ne aiming laser and a CO2 therapeutic laser. since all reusable accessories will need to be checked for both coincidence and pattern.7. in no case should it exceed 500 µA.5 Footswitch Exposure Control. If the power meters can react to pulse duration (this is the preferred circumstance). Set the laser to about 5 W and a 0. activate the unit. activate the therapeutic laser. With the laser set at about 5 W and an exposure duration of about 0. which repeats the pulse at a fixed or adjustable rate. (It may be convenient to perform this test in conjunction with Item 2. Some laser power meters can react quickly enough to be used to test this feature of the laser. Where it is greater than 300 µA.g. and the center of the burn and the center of the circle should be in virtually the same location (see Fig. a tongue depressor). test that setting changes made throughout the range result in the expected performance. You should obtain a series of burn spots of similar density and size as long as you maintain the same handpiece-totongue-depressor distance and angle relationships for each exposure and as long as the laser is operating properly. The 2. position the micromanipulator so the lasing beam is perpendicular to the face of the wooden tongue depressor and focused to its smallest spot on the depressor. To check concentricity of the two lasers. and activate the laser at each setting.

However. .Inspection and Preventive Maintenance System dirty mirror can disturb the beam pattern significantly and can affect the clinical performance of the laser. (In this case. the angle or degree of rotation of one arm section in relation to another section or the chassis) changes. may be difficult to view with the aiming beam on.. Lasers using mirrors in articulating arms are subject to beam wander. When using laser paper. Some laser delivery systems (e. articulating arm. do not focus the beam on the surface. If a problem is found in beam alignment or pattern without a corresponding problem with the micromanipulator. A misaligned or Beam pattern can be roughly assessed by evaluating the uniformity of a burn on a tongue depressor (as described in Item 2.) Repeat this testing with each reusable accessory. The burn (or spot on an imaging plate) should be fairly consistent in darkness throughout and circular in shape (see Fig. It is possible for the aiming and therapeutic lasers to appear to be concentric and to develop an even burn. It is not necessary to test the effect of manipulating the articulating arm for each accessory. When the therapeutic laser impacts the surface. measuring relative change in spot size caused. (Alignment is very difficult and should be performed only by qualified personnel. If the aiming and therapeutic lasers diverge significantly during any test. Laser beam pattern is a measure of how well the mirrors of the laser tube. and the greater the risk that a surgeon will inadvertently irradiate unintended tissue. including handpieces. Handpieces can be positioned and secured in the vise or ring stand.) Figure 2. 2. and the cost of equipment exceeds the expected benefits to an inspection program. despite a poor beam pattern. the maximum power [see Item 2.7 Laser Beam Pattern. for example. 3). errors in mirror adjustment or dirt on the mirrors can qualitatively seem to cancel each other.10 can help to pinpoint the source of the problem. The spot created by a therapeutic laser beam perpendicular to the target should be circular. The surface of the thermal imaging plate is exposed to an ultraviolet light. Comparing the results of this item’s testing with those of Item 2. and the energy throughout the spot should be fairly uniform.1 sec exposure setting or the nearest available setting. and laser bronchoscopes.g.6) or laser thermal imaging paper or by using thermal imaging plates. the thermal energy creates a beam pattern that appears as a brown spot. and the surface fluoresces. the source of the problem is probably in the accessory. All Rights Reserved. The plates are designed to respond to different power densities of CO2 laser energy. by changing 8 Inspection and Preventive Maintenance System ©1995 ECRI. Measuring absolute spot size from a laser is difficult. results are not always comparable.. and handpiece are aligned and performing. Circled He-Ne aiming beam spot (shaded) and therapeutic laser spot (dark). repeat this test with the articulating arm in several physical configurations. laser laparoscopes. The beam must be perpendicular to the target surface. micromanipulators) provide features that allow the user to change the spot size. always start with the least sensitive surface. To minimize the risk of damaging a plate’s surface. the poorer the alignment. Position the target beyond the point of focus to expand the spot. in which concentricity of the aiming and therapeutic laser may change as the physical orientation of the articulating arm (e.g. the laser should be set at about 5 W and operated in the Pulsed mode at a 0. Thermal imaging plates may provide an indication of beam pattern but do not provide a permanent record for later comparison. thereby decreasing the power density in the spot. the system requires complete alignment.10] that can be developed usually drops. and may be easily damaged if accidentally overexposed. demonstrating concentric alignment (left) and poor alignment (right) more the centers of the burn and circle diverge. Hence. Also.

or after the last service procedure.3 3.. All Rights Reserved..4 4. or printer components with the lubricant recommended by the manufacturer. 9 . If the laser includes a low-power (e. Compare relative spot size. fan. activate the laser for a sufficient period to acquire acceptable readings. Acceptable therapeutic beam pattern (left) and unacceptable (right) lenses or the aperture setting on micromanipulators is worthwhile and can be accomplished without undue cost. You can evaluate the change in relative spot size using either of the test methods detailed above (i. at the last preventive maintenance procedure. (Power meters use different time constants to acquire an acceptable reading. WARNING: Lasers may be damaged by switching between normal and reverse polarity while the device is on. Place and secure the laser handpiece or aperture of the articulating arm at the appropriate distance from the laser power meter to meet spot-size requirements specified in the instructions with the meter. expose the thermal imaging plate or laser paper to the focused beam created when using each lens. If you use fixed points or continuously variable aperture control to change the spot size. Preventive maintenance Verify that all daily preventive maintenance procedures recommended by the manufacturer are carried out.g. Check all fluid levels and supplement or replace fluids if needed.g.2 3. compare the reading with the reading taken on incoming acceptance testing. turn off the unit being tested before switching Inspection and Preventive Maintenance System ©1995 ECRI. Ensure that all hoses and tubes are tight. and beam uniformity. (Some power meters require that the aperture of the articulating arm be inserted into or placed in direct contact with the power meter. 3. 50% of full scale).. the measured and displayed values should all be within 10% of one another. using a thermal imaging plate or laser paper). Only appropriately trained personnel should attempt laser adjustments. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. Replace filters. nondiverging laser beam. Clean accessible optical components (e. expose the thermal imaging plate or laser paper to the focused beam created when the aperture control is set at its minimum. spot shape.g. and maximum aperture settings. If the handpiece is used on these meters. and compare the relative spot size. and you must know and meticulously follow the power meter’s instructions for use. test it in a similar fashion with a power meter of appropriate low-power resolution. Figure 3. exercise great care if the interlocks are to be defeated. if needed. mW) feature. If reverse-polarity leakage current measurements are made..10 Power Output. Calibrate/adjust any components (e. 2.1 Clean the exterior. Lubricate the telescoping column and any motor.Carbon Dioxide Surgical Lasers Because of the heightened risk associated with an unfocused. spot shape.g. median. With the laser set at a low (e. compressor. and beam uniformity of the images or imprints.) WARNING: Accessing the unfocused laser beam may require defeating internal interlocks. medium (e. If you use different lenses to change the spot size. pump.. 3. the meter may be damaged by the high power density caused by the focused beam.) Compare the reading obtained with the power display of the laser. a significant change in output may indicate the need for service. printer) according to manufacturer recommendations. 3. and maximum output. microscope lenses) if necessary. using techniques and cleaning solutions recommended by the manufacturer.. 10% of full scale). In addition.g.e.

Thus. verify that adjusting the power setting incrementally through its full range produces the expected effect on a tongue depressor. Casters/Mounts/Holders. are functioning properly. at several low. ensure that it has nonslip legs or supports. including leakage current measurement. it is particularly important to use a firebrick behind the tongue depressor for added safety.4 Before returning to use Be sure to return controls to their starting position. For all tests using high continuous-wave or Superpulse. All Rights Reserved. Test the power output accuracy. Ensure that the branch circuits and the outlets for the laser are properly wired and rated for use with the laser. Power Range.Inspection and Preventive Maintenance System polarity. The handpiece (which could conceivably come into contact with a patient’s heart) should meet the criteria for isolated input devices.g. Repeat Pulse. and high settings. and place a Caution tag in a prominent position so that the next user will be careful to verify control settings. verify that progressive increases in pulse duration throughout its range of adjustment result in progressively larger burns. Electrical Wiring Configuration. If the laser includes an enhanced pulse feature and the pulse duration is adjustable. and ensure that laser signs. Ensure that the assembly is stable and that the unit will not tip over when pushed or when a caster is jammed on an obstacle (e. do not switch conductor connections or wiring configurations for any tests. 4. Visit the area(s) in which the laser is to be used. (Consult National Electrical Manufacturers Association [NEMA] configurations for general-purpose nonlocking connectors if in doubt. If the laser includes a Repeat Pulse feature. In addition. location. Examine the receptacles at each location where the laser is to be used to ensure that the proper electrical configuration (e. Examine the unit and note the presence. test this feature as described in Item 2. laser safety eyewear. proper phase rotation) has been installed. as may occur during transport.) Pulse Duration. using the technique described in Item 2.2 4.g. 10 Inspection and Preventive Maintenance System ©1995 ECRI. and function before using the unit.6 4. Labeling information is typically found in the laser’s operator manual. a line cord threshold). Do not conduct electrical leakage current tests with reversed-polarity wiring.10.4. .8 4. Also. lasers powered by three-phase electrical systems may be damaged if proper electrical phase connections are not made initially and maintained thereafter. Connect the laser to each receptacle and confirm that the laser operates properly.7 4. Also test the ability of the laser to deliver laser energy as expected in all configurations and with all provided laser accessories. if present.1 Areas of Use. Verify that the plug is acceptable for use with the maximum current and voltage specifications for operating the laser.3 4. but over the full range of available settings.. perform the following tests. and content of all labels. If the device is designed to rest on a shelf.. setup. 4. If the laser includes an enhanced pulse feature.5 AC Plug. proper neutral and ground connections. Labeling. 4. medium. specifically confirming that motors are operating in the proper direction. and window coverings are available and being used and that safety interlocks for doors or windows.

USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. . Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. to be used only when referring to that device) Commonly Used In: Emergency departments. and mouth-to-mouth breathing. PA 19462-1298. By eliminating the need to rotate personnel for the fatiguing task of cardiac compression. does not apply to cardiac presses that are not pneumatically powered Risk Level: ECRI Recommended. Overview Pneumatically powered cardiac resuscitators are used during emergency cardiopulmonary resuscitation (CPR) as an alternative to manual cardiac compression. They can provide consistent cardiac compression.Procedure/Checklist 421-0595 Cardiac Resuscitators Used For: Resuscitators. 1973 Apr. with adequate sternal depression and rhythmic compression rates. Procedure Before beginning an inspection. ambulances Scope: Applies to cardiac resuscitators. 2:136-50. Test apparatus and supplies Pressure gauge or meter with a range of at least 0 to 80 cm H2O Spirometer or gasometer Beam balance patient floor scale Stopwatch or watch with a second hand Ruler Special precautions Never oil any part of an oxygen-powered cardiac compressor. Cardiac [13-361] Also Called: External cardiac compressor. applied. High. Type Major Minor ECRI-Recommended Interval 12 months* NA Interval Used By Hospital months months Time Required . 009010 421-0595 A NONPROFIT AGENCY 5200 Butler Pike. Plymouth Meeting. hours hours *An interval of 6 months should be considered if a resuscitator is frequently used and/or located in an ambulance. as well as oxygen-enriched ventilation.. Hospital Assessment. critical care areas. be sure that you understand how to operate the equipment and the significance of each control and indicator. these devices reduce the number of people required to maintain support of the patient. Thumper (registered trademark of Michigan Instruments. the patient must be maintained by manual techniques until the cardiac resuscitator is available. Oil in the presence of oxygen is a dangerous fire and explosion hazard. and placed in operation. Inc. Use of pneumatically powered cardiac resuscitators does not eliminate the need to train hospital and ambulance personnel in effective airway maintenance. Citations from Health Devices External cardiac compressors [Evaluation]. carefully read this procedure and the manufacturer’s instruction and service manuals. manual external cardiac compression.org . In all cases.

It should raise the balance beam. Where a control should operate against fixedlimit stops. unless otherwise specified by the manufacturer. 2. During the course of the inspection. If it does not. All Rights Reserved. If an oxygen cylinder is stored with the resuscitator. Check that the items on the accessories list are found with the resuscitator at each inspection. Be sure that plastic housings are intact. Reinflate inflatable rims if they are collapsed. Compression Force. Examine all controls and switches for physical condition. secure mounting. count the number of compressions per minute with it operating. Maintain a full cylinder with the unit. kinked. confirm the operation of all indicators. The compression rate. Mount. If the gauge measures pressure. Be sure that they are not cracked. check their positions.10 Fittings/Connectors. Determine if the ventilation gauge measures pressure (cm H2O) or volume (cc). Activate the compressor.3 Compression Rate with Ventilation. Connect the compressor to its normal oxygen source. 1. check that the compression piston moves freely in and out of its cylinder. Verify that the ventilation hose terminates at the patient end in a standard 15/22 mm coupling to allow connection to a standard ventilator mask and tracheal or tracheostomy tube.13 Controls/Switches. With the unit not operating. 1. 60 to 80/min). Check the condition of all tubing and hoses. Observe that pin-index safety system pins are present and intact. use blocks or other objects to level it again. Qualitative tests 1. 1. Use only transparent masks with resuscitators. A cylinder wrench should be chained to the regulator and yoke assembly. An assortment of masks (e. Tubes/Hoses. Piston Displacement. and correct motion. If any of them appear inordinate. During the course of the inspection. . Using a stopwatch or watch with a second hand. conversion charts.1 Chassis/Housing.Inspection and Preventive Maintenance System 1.18 Indicators/Displays. Replace if necessary. or dirty. Cylinders.e.. Confirm that appropriate quick-connect fittings are being used with corresponding gases. 1.8 1. If the scale is at a significant angle from its original position.6 Ventilator Regulation. be sure to check that each control and switch performs its proper function.g. and check for leaks or damage by immersing the mask in water. check the amount of oxygen it contains. gauges. Inspect the masks for signs of deterioration. an adapter should be provided. If the device is mounted on a stand or cart. Quantitative tests 2. make it more versatile for a wider range of patients.4 2. consider the possibility of inappropriate clinical use or of incipient device failure. and that there are no signs of spilled liquids or other serious abuse. Position the compression piston on the weighing platform of a conventional patient floor scale by tilting the scale back and sliding the compressor base plate under the platform. order transparent replacements but do not remove opaque masks from use until replacements are available and the change has been discussed with users. Set the scale to 45 kg (100 lb) and adjust the compression force control to its maximum point. 1. If the unit includes a ventilator.5 2 Inspection and Preventive Maintenance System ©1995 ECRI. adult. labels. should be in accordance with AHA/ARC two-person CPR standards (i. infant) should be stored with the resuscitator to 2. that all assembly hardware is present and tight..2 1. Before moving any controls. check for proper alignment as well as positive stopping. 1. Check that all necessary placards. Record the settings of those controls that should be returned to their original positions following the inspection. Examine the exterior of the unit for cleanliness and general physical condition. The maximum displacement should not exceed 5 cm (2 in). connect the ventilator output to a pressure gauge or meter or a water manometer and compare the 2. List the accessories that are to be stored with each resuscitator. and instruction cards are present and legible.23 Accessories. Masks. examine the condition of the mount. If opaque masks are in use. Examine all accessories for cleanliness and mechanical integrity. and visual displays on the unit. count the number of compressions over a 1 min period.24 Ventilation Hose Fitting.22 Labeling.

9 Compression/Ventilation Ratio. Before returning to use Make sure controls are set at normal positions and oxygen cylinders are turned off. The difference between measured and indicated values should not exceed 20%.) 2. It should be at least 1. connect the ventilator output to a spirometer or gasometer. All Rights Reserved.Cardiac Resuscitators measured ventilation pressure to that indicated on the gauge at 30 and 50 cm H2O. Place a Caution tag in a prominent position so that the next user will be careful to verify control settings. Ventilator Volume Output. 2. setup. Adjust the ventilator control to its maximum setting and measure the maximum ventilatory pressure. Adjust the ventilator control to its maximum setting and measure the maximum inspiratory volume. Acceptance tests Conduct major inspection tests for this procedure. Preventive maintenance 3. It should not exceed 60 cm H2O. If the gauge measures volume. Connect the patient end of the ventilator tubing to a pressure gauge or meter. (Such high errors are tolerable in short-term emergency equipment but would not be acceptable in other ventilators. 3 . With the compressor and ventilator operating. 3.7 Inspiratory Pressure. 4. count the number of piston thrusts between each ventilation.8 Inspection and Preventive Maintenance System ©1995 ECRI.1 Clean the exterior. 2. Compare the measured ventilation volume to that indicated on the unit’s gauge at the 1 L setting. and function before use. This test confirms operation of the inspiratory pressure-relief valve.5 L. Connect the output of the ventilator to a spirometer or gasometer. There should be five compressions per ventilation.

Or the operator may be harmed while attempting to slow down or stop the rotor by hand.org . Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . high speed (6.Procedure/Checklist 456-0595 Centrifuges Used For: Centrifuges [10-778] Centrifuges. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. Cell Washing. such as using correct tube sizes and locations and using cushions.000 rpm). Centrifugation is used for most sample preparations in a clinical laboratory. broken glass. Rotors may detach or fail. Hazards also exist when the centrifuge is not in operation.000 rpm. Floor. Hospital Assessment. These three types of centrifuges are available as tabletop and/or floor models. and ultraspeed (25. are not followed. These liquids can include body fluids (blood. Automatic [16-815] Centrifuges. may be found inside the centrifuge during cleaning or IPM. Tabletop [10-780] Microcentrifuges [17-452] Ultracentrifuges [15-193] Commonly Used In: General clinical laboratories. Cytological [16-765] Centrifuges. Nonrefrigerated [17-177] Centrifuges. hours hours Overview Centrifuges use centrifugal force to separate suspended particles from a liquid or to separate liquids of various densities. Certain hazards are associated with the operation of centrifuges. Aerosols may be created from the samples. breakage is most likely to occur if manufacturers’ instructions. serum. 236945 456-0595 A NONPROFIT AGENCY 5200 Butler Pike. as well as specific laboratory departments (e. clinical chemistry) Scope: Applies to all types of centrifuges Risk Level: ECRI Recommended. Medium. Floor [15-116] Centrifuges. rotor or tube failures may result in operator exposure to physical or infectious hazards. and some are refrigerated units. Blood Bank [15-115] Centrifuges. possibly contaminated with blood.000 to 15. . blood bank. and safety inner protective lids should be used when available.000 rpm). the lid should never be opened while the rotor is spinning. Therefore. Microhematocrit centrifuges are specialized centrifuges used in a hematology department to determine an accurate packed cell volume of red blood cells. commercial reagents. PA 19462-1298. hematology. Plymouth Meeting.000 to 25. for example.000 to 110. urine).. There are three general classifications of centrifuges: low speed (≤6. Refrigerated [15-117] Centrifuges.g. possibly because of a loose retaining nut or imbalanced tube placement.000 rpm). Microhematocrit [10-779] Centrifuges. Sample tubes may break. or combinations of the two with other additives. The speed of a microhematocrit centrifuge ranges from 7.

gowns or laboratory coats. Use proper-sized tubes for the rotor. equipment with appropriate safeguards should be used.** Citations from Health Devices Tabletop centrifuges [User Experience NetworkTM]. Centrifuges [Hazard summary]. Missing roll pin from Beckman Spinchron centrifuge rotor [User Experience NetworkTM]. Ensure that the centrifuge tubes are properly balanced and that the speed and tube length are in accordance with the tube and centrifuge manufacturers’ recommendations. and the alarm capabilities. Check and record built-in tachometer monthly. Improper sealing of Baxter Megafuge C1725-2 centrifuges [Hazard].. Check and record speed (rpm) accuracy monthly (critical use) or quarterly. 21(8):290. which permits the lid to be opened only after the rotor has stopped (or reached a very low speed). carefully read this procedure and the manufacturer’s instruction and service manuals.) Check and record timer accuracy monthly.. 21(5):182. No. Centrifuges [Hazard report summary]. ALWAYS follow universal precautions when centrifuging blood or body fluids. be sure that you understand how to operate the equipment. face protection (e. Body Fluids. 1989. 1992 Sep. Procedure Before beginning an inspection. A centrifuge should be vacuumed out before any testing is started. 4th edition. 16(2):55. Laboratory personnel should have properly decontaminated the centrifuge.5°C (for refrigerated units only) Tachometer or phototachometer Special Precautions Check with laboratory personnel before performing any maintenance or shipping centrifuges to the manufacturer for repair. 10% sodium hypochlorite] may damage the rotor and other centrifuge components. Fed Regist 1991 Dec 6. shields). long tubes (e. As a minimum. 14. 21(9):331. ensure that the tubes are placed in accordance with the manufacturer’s instructions.. and plastic aprons. These precautions include wearing gloves. 1992 Aug.g. ** Occupational exposure to bloodborne pathogens. and are described in detail in the National Committee for Clinical Laboratory Standards (NCCLS) Document M29-T2. the significance of each control and indicator. (Note: Contact the manufacturer for guidance if the operator’s manual does not specify cleaning or disinfecting agents. 1992 May. is preferred.g. Lancaster Ave. which may be contaminated with blood. Vol. (Broken glass. Laboratory personnel are required by the College of American Pathologists (CAP) to do the following: Clean and properly maintain all centrifuges. units should have a lid and a latch that will prevent the lid from opening in the event of a failure while the rotor is spinning. is sometimes found inside. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. 21(12):459.) Electronic thermometer accurate to 0. 24: 158-9. Protection of Laboratory Workers from Infectious Disease Transmitted by Blood. 1995 Apr. 100 mm) placed in the corner tube holders closest to the rotor shaft will probably break when the rotor buckets swing out. and Tissue (tentative guideline). All Rights Reserved. * This document can be obtained from the NCCLS. 771 E. (610) 525-2435. (Note: Operators should refer to CAP’s Laboratory Instrument Evaluation Verification & Maintenance Manual. ensure that such solutions are removed by rinsing well with water. Test Apparatus and Supplies Wrench to tighten the rotor nut Leakage current meter or electrical safety analyzer Ground resistance ohmmeter Stopwatch or watch with a second hand 2 Inspection and Preventive Maintenance System ©1995 ECRI. 1992 Dec. 16(7):255. .. IEC DPR-6000 refrigerated centrifuges [User Experience NetworkTM]. 1987 Feb. Prolonged contact with some disinfection solutions [e. 56(235):64004-182. 1987 Jul. If using a swinging-bucket rotor. A safety interlock.) Be careful not to touch a spinning rotor if an interlock fails or if you are operating the unit with the lid open. NEVER attempt to stop a moving rotor with your hands or with a tool or object. In addition. Risks from centrifuges [Hazard]. 11.Inspection and Preventive Maintenance System In addition to careful adherence to use and maintenance instructions. Villanova PA 19085.g. and all new units should have this feature.* as well as in the Occupational Safety and Health Administration’s (OSHA) bloodborne pathogens standard. visible blood may be located on or in the centrifuge.

confirm the operation of all lights. check the security of the shelf. sample buckets.. commutator. the buckets or rotor should have an inner protective lid. 1. if a lid is retrofitted.4 1. During the course of the inspection. Mount/Fasteners. Examine all controls and switches for physical condition. as well as the operation of a volume control. Confirm the presence and condition of accessories (e. check for proper alignment. warning the operator not to open the centrifuge lid during operation. and verify that alarms are activated. Check membrane switches for membrane damage (e.22 Labeling. Be sure that they hold the cord securely. and perform appropriate maintenance according to the manufacturer’s specifications. Before changing any controls. Attempt to wiggle the blades to check that they are secure. secure mounting. Be sure that plastic housings are intact. If the lid can be opened with the rotor spinning at high speed. follow the manufacturer’s derating schedule for the rotor. Check the physical condition and proper operation of these components. pens). seals. 3 . gauges.1 and 3. Examine the strain reliefs at both ends of the line cord. 1. 1..5 1. If the device is protected by an external fuse. A lid interlock should either shut off the motor when the lid is opened or keep the lid latched until the rotor has stopped. Examine the AC power plug for damage. Inspection and Preventive Maintenance System ©1995 ECRI. be sure to check that each control and switch performs its proper function. The centrifuge should not start with the lid open. that all hardware is present and tight.) Clean and lubricate components as required. check its value and type against those marked on the chassis and ensure that a spare is provided. All Rights Reserved. Check that all necessary placards.15 Motor/Rotor/Pump. Check the lid latching mechanism for wear. Line Cord.20 Alarms/Interlocks. Operate the device to activate any audible signals.Centrifuges 1. During the course of the inspection.2 1. check that it moves freely. it should have a safety latch. Confirm appropriate volume. Strain Reliefs. If it rests on a shelf. Where a control should operate against fixed-limit stops.) Circuit Breaker/Fuse. If the device has a switch-type circuit breaker. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that all segments of a digital display illuminate and function properly. if so equipped. Do not use centrifuges that lack a lid. cut out the defective portion. and correct motion. indicators.18 Indicators/Displays. AC Plug. Replace or modify any centrifuges that lack a latch. If the lid can be opened while the centrifuge rotor spins at a low speed. do not check these items until all necessary cleaning and lubrication are completed).6 1. as well as positive stopping. It should be outlined in the operator’s manual. sample 1. Check the rotor for balance and the condition of trunnion bearings. 22[5-6]:301-3. If the line cord is detachable (by the user). replace the entire cord or. Check the condition of gaskets. Check the brushes.23 Accessories. If units have suction-type feet. and check the rotor attachment for tightness and excessive wear. and verify that it holds the lid securely. conversion charts.2 of the inspection form (however. open the plug and inspect it. check its condition. check the integrity of the feet.1 Chassis/Housing. consider the possibility of inappropriate clinical use or of incipient device failure. if the damage is near one end. Qualitative tests 1. and that there are no signs of spilled liquids or other serious abuse. Be sure to wire a new power cord or plug with the correct polarity. Refrigerated units should indicate whether the unit is at the appropriate temperature. Shake the plug and listen for rattles that could indicate loose screws. If a unit has a vacuum or diffusion pump. (See Health Devices 1993 May-Jun. (Note: If using an ultraspeed centrifuge. examine its condition. Induce alarm conditions. from fingernails. Inspect the cord for signs of damage.7 1. 1. and mounts.g. check for appropriate labeling on or near the centrifuge. and bearings of the motor.g. and instruction cards are present and legible. and note this on Lines 3. attach the cord to the unit so that it cannot be easily removed. If the device is mounted on a stand. If damaged. meters. Record the settings of those controls that should be returned to their original positions following the inspection. and visual displays on the unit. If any damage is suspected. Check that control knobs have not slipped on their shafts.13 Controls/Switches. labels. 1.21 Audible Signals. 1.

All new centrifuges should have a lid and a safety interlock that prevents the lid from being opened while the rotor is spinning at high speeds. (For the proper procedure for replacing brushes. All Rights Reserved.g. also ensure that the protective lids form a tight seal and positively lock onto the bucket.) 2. Lubricate per manufacturer’s instructions. If a unit has an opaque cover. Replace brushes. 2. and off. Compare the temperature control with the electronic thermometer at each setting or at the settings being used. measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. Quantitative tests 2. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. gaskets. Place the electronic thermometer probe in the centrifuge bowl near the automatic temperature control sensor. 4 Inspection and Preventive Maintenance System ©1995 ECRI. 1. brake.4 Clean exterior (interior if appropriate). grounding resistance need not be measured.Inspection and Preventive Maintenance System holders). Give preference to those centrifuges that have protective lids for the buckets or rotor. or multimeter with good resolution of fractional ohms. sealing the gasket around the thermometer cable. check speed settings after brushes are properly replaced.2 4. If protective lids for the buckets or the rotor (inner safety lid) are available for that model centrifuge. Preventive maintenance 3.) The measured speed should not vary by more than ±10% of the displayed speed. refer to the manufacturer’s service manual to check the speed accuracy. those that have a protective lid for the buckets or an inner safety lid for the rotor. and vacuum pump. The readings should not differ by more than ±3°C.2 3. seals. When the brake is applied (e. proper-sized tubes for the buckets used). 3. verify that they are kept with the centrifuges and are routinely used. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Depending on various state regulations.g. Attach a caution tag in a prominent position to alert the user that control settings may have been changed. indicate “DI” instead of the ground resistance value. We recommend a maximum of 0.12 Accuracy of Speed Setting.. Check for the proper type of accessory (e. set the thermostats so that each operates while taking measurements. Purchase only those centrifuges on which the rotor stops completely before the lid can be opened and/or.g. should not vary by more than ±10%. 2. Check the action of the mechanical or electrical brake. (Note: A vibrating reed-type tachometer may be used with most centrifuges with opaque covers. Determine the range of speeds at which the centrifuge is used and a typical load (e. including on.5 Ω. Check the timer against a stopwatch or watch with a second hand. if needed. Chassis leakage current to ground should not exceed 500 µA. refer to the manufacturer’s manual and to the CAP Laboratory Instrument Evaluation Verification & Maintenance Manual.10 Temperature Accuracy. If the units being purchased allow the lid to be opened while the rotor is spinning at low speeds. protective lids should be included. this value may need to be recorded on the inspection tag. the centrifuge should decelerate smoothly. and record the maximum leakage current.24 Brake. If the unit has heating and cooling modes. Using an ohmmeter. Set the centrifuge to two or three speeds.11 Timer Accuracy.. Leakage Current. for units that operate at a low speed.. and measure the different speeds using a tachometer. Operate the device in all normal modes. Check the temperature control on refrigerated centrifuges using an electronic thermometer. . If the device is double insulated.) 2. standby. Check that every tube holder has a cushion. electrical safety analyzer. (Refer to the manufacturer’s specifications to determine where the temperature control sensor is located. (Note: If brushes have been changed.1 3.1 Grounding Resistance. by pushing the STOP button).) Close the centrifuge. number of filled containers). 2. A centrifuge Before Returning to Use Make sure controls are set in their normal pre-use positions.

each manufacturer uses a unique flow pattern. Pads are constructed from two plastic sheets that are heat-sealed together. A fluid pump consists of a reservoir that holds a supply of distilled water. Circulating-Fluid.org . Heating pads are available in three types: all-plastic single-patient-use. 1989 Dec. a controller that maintains the fluid temperature. Citations from Health Devices Circulating-fluid pumps and heating pads [Evaluation].4) Flowmeter (0 to 20 gallons per hour [gph] range) with water Heating pad 009064 412-0595 A NONPROFIT AGENCY 5200 Butler Pike. Circulating-fluid pumps: Do not use for ECMO [Hazard]. made from thick plastic sheets to resist wear and improve durability (these come with a repair kit). Plymouth Meeting. Localized Heat [17-647] Also Called: Heating pads. 1989 May. and all-plastic reusable. which have a layer of fabric bonded to their surface. 18:418. Test apparatus and supplies Ground resistance ohmmeter Leakage current meter or electrical safety analyzer Shunt thermometer with appropriate connectors to install in series with the pump and heating pad to check the temperature of the circulating fluid (temperature calibration assemblies may be available from manufacturers of circulating-fluid pumps and may be used in place of the temperature-measuring procedure described in Item 2. a registered trademark of Baxter to be used only when referring to that device. Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . some of which can be reused. T-Pump. a registered trademark of Gaymar Industries Inc. to be used only when referring to that device Commonly Used In: Most patient care areas Scope: Applies to circulating-fluid heating pad pumps Risk Level: ECRI Recommended. covered single-patient-use. mounted in the reservoir. The pump circulates the distilled water through a plastic pad. PA 19462-1298. a pump that circulates the fluid to the heating pad. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. 18:154-73. that warms the fluid. 1992 Jan. Circulating-fluid pumps and heating pads [Evaluation Update].Procedure/Checklist 412-0595 Circulating-Fluid Pumps Used For: Pumps. Hospital Assessment. a heater. 21:39. hours hours Overview Circulating-fluid pumps and pads are used for applying long-term mild heating to the skin. and safety devices that deactivate the unit if the fluid temperature exceeds the maximum allowable temperature limit. K-Module. the pad is placed under or on the skin to allow conductive heat flow. Low. .

that a variable temperature control does. if the damage is near one end.g. that On/Off controls work). Examine the strain reliefs at both ends of the line cord. examine the condition of the mount. Ensure that the assembly is stable. from fingernails. check for proper alignment.15 Motor/Pump/Fan. or. Attempt to wiggle the blades to determine that they are secure. in fact. or visual displays on the unit. Operate it to be sure that its controls function properly (e. 1. Where a control should operate against fixedlimit stops. Examine the exterior of the unit for cleanliness and general physical condition. Shake the plug and listen for rattles that could indicate loose screws. Return the unit to its normal operating condition immediately after completing the test. If any of them appear inordinate (e. If the device is protected by an external fuse. 1. and correct motion.4) after the high-temperature protection test (Item 2.Inspection and Preventive Maintenance System Special precautions Some testing requires disabling temperature control circuits.3) will help ensure that the device has been correctly returned to its proper operating condition. Inspect the cord for signs of damage. Examine the AC power plug for damage. During the course of the inspection.1 Chassis/Housing. Verify that the pad warms up when the unit is operated to ensure that the heater and the pump are functioning. and the alarm capabilities. Performing the operating temperature test (Item 2. be sure to check that each control and switch performs its proper function. Procedure Before beginning an inspection. that necessary assembly hardware is present and tight. indicators. Line Cord. for general condition. 1. seek qualified help when performing this test. determine the amount of heating. Check physical condition and for proper operation. as well as positive stopping. secure mounting. Check all fluid levels. replace the entire cord.16 Fluid Levels. and that there are no signs of spilled liquids or other serious abuse. If any damage is suspected.g. consider the possibility of inappropriate clinical use or of incipient device failure.18 Indicators/Displays. If damaged. or dirty. the significance of each control and indicator. 1. this testing should be performed only by qualified personnel familiar with unit design..7 1. Be sure that they are not cracked..8 1. 1.g.13 Controls/Switches. open the plug and inspect it. Be sure that they hold the cord securely.. Examine all controls and switches for physical condition.2 1. If the device is mounted on a stand or bracket. carefully read this procedure and the manufacturer’s instruction and service manuals. During the course of the inspection. Circuit Breaker/Fuse. cut out the defective 1. Check for weld cracks. pens). Strain Reliefs. 1. a temperature control at maximum). Examine liquid fittings and connectors. Check the condition of all tubing and hoses. as well as all electrical cable connectors. Be sure that plastic housings are intact. Qualitative tests 1. Check membrane switches for membrane damage (e. Verify that the mounting apparatus is secure and that all hardware is firmly in place. check their positions. confirm the operation of all lights. be sure that you understand how to operate the equipment. check that it moves freely.4 1.5 2 Inspection and Preventive Maintenance System ©1995 ECRI. kinked. All Rights Reserved. Be sure to wire a new power cord or plug with the correct polarity.10 Fittings/Connectors. 1.14 Heater. Replenish any fluids that are low. check its value and type against that marked on the chassis. AC Plug. Although we hesitate recommending such wiring modifications as part of a routine inspection procedure because unskilled personnel may inadvertently damage the unit. there may be no other way to determine whether the backup thermostat or overtemperature alarms are functional. 1. to avoid damage to the unit. . Before moving any controls. and ensure that a spare is provided. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.6 portion. If the device has a switch-type circuit breaker. Personnel responsible for inspecting heating pads must recognize their own limitations and. Mount/Fasteners. Record the settings of those controls that should be returned to their original positions following the inspection. Tubes/Hoses. where appropriate.

labels. and note any alarms or indicators.g.. including on (with the heater operating) and off.3 Before returning to use Verify that any control circuits that were bypassed or deactivated for testing purposes have been returned to their normal operating condition. Quantitative tests 2. Remove any bypasses installed for this test. The flow should exceed the minimum flow specified by the manufacturer. Also verify the presence and operation of a key for adjusting fluid temperature. Check that all necessary placards. 2. electrical safety analyzer. but should not exceed 43°C. free of leaks. or multimeter with good resolution of fractional ohms.3. Leakage current should not exceed 300 µA.1 Grounding Resistance. if needed.4 Clean the exterior. and instruction cards are present and legible. and place a flowmeter (0 to 20 gph range) in series with the input line to the heating pad. 2. Flush/fill the reservoir. Circulating-fluid pumps should have high-temperature protection (backup thermostats) to limit the water temperature if the main temperature control fails. and record the maximum leakage current. and stored without sharp folds or creases. Flow. 2. Record the flow rate. We recommend a maximum of 0. Connect the shunt thermometer in series with the input line to the heating pad. 1. 2.3. Many units have low-water-level and high-temperature alarms. Operate the device in all normal modes. High-Temperature Protection.2 4. Preventive maintenance 3. Operate the unit in such a way as to activate the low-water-level alarm and any other audible and visual alarms (e. Actual water temperature should be within 1°C of the set temperatures. Verify that the pad is clean.23 Accessories. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. Operate the pump at 37°C and at maximum control settings with the thermometer shunt still installed as in Item 2. Inspection and Preventive Maintenance System ©1995 ECRI. Remove the temperature shunt. Maximum temperatures should be within the manufacturer’s specified range.5 3. All Rights Reserved. Verification of the high-temperature alarm requires abnormal operating conditions that will be simulated in Item 2. Leakage Current. Operating Temperature. Using an ohmmeter.Circulating-Fluid Pumps 1. 1. tilt).4 Determine from the manufacturer’s literature how backup thermostats can be tested. 2.1 3. Measure chassis leakage current to the chassis of the device with the grounding conductor temporarily opened.22 Labeling. Record the maximum water temperature for each backup thermostat.5 Ω.20 Alarms. 3 .

and nitrous oxide. Flammable anesthetics are used only for rare circumstances (e. Flammable anesthetics were once a necessary part of surgery. nonflammable inhalation anesthetics are now available and are used in most cases. For example. 1993 Edition. .. Plymouth Meeting. antistatic precautions are not required. electrosurgical or electrocautery equipment. diethyl ether.Procedure/Form 441-0595 Conductive Furniture and Floors Used For: Flooring.g. Conductive [15-832] Used In: Operating rooms. cyclopropane. Standard for Health Care Facilities. Other possible sources of ignition include heating or sparking in electrically powered devices. other flammable anesthetizing locations Scope: Complies with the requirements for periodic testing of conductive casters on equipment and furniture used in flammable anesthetizing locations and conductive flooring installed in these areas Type Major Minor * ECRI-Recommended Interval 1 month* NA Interval Used By Hospital months months Time Required . Conductive floors and electrical interconnection of all furniture and devices with conductive surfaces minimize the risk of electrostatic charge accumulation and resultant spark. low resistance is not required for conductivity established for the purpose of electrostatic control. NFPA 99.3.000 Ω and less than 1 MΩ. Unlike the requirements for grounding medical devices to ensure safety from electrical shock. The most likely ignition source for these gas mixtures in the operating room or other flammable anesthetizing locations is a spark caused by an electrostatic (static electricity) discharge. and percussion sparks.. Section 12-4. oxygen. ethyl chloride. Overview Some inhalation anesthetics (e. but conductivity need not be maintained or 010828 441-0595 A NONPROFIT AGENCY 5200 Butler Pike. In areas designated and posted for the use of only nonflammable anesthetics. hours hours This procedure is not required in areas where flammable anesthetics are no longer used and where the floors have been treated to make them nonconductive.org . ethylene) are flammable and pose a considerable fire and explosion risk when mixed with air. however. Equipment or furniture with conductive casters can be used in nonflammable anesthetizing locations. it is sometimes preferable to ensure that a certain minimum level of resistance be maintained to minimize electric shock hazards.1. Rather. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. contains requirements calling for all furniture and devices located in a flammable anesthetizing location to have conductive casters (or equivalent means) to ensure continuity with the conductive flooring. PA 19462-1298.g. where a flammable anesthetic is claimed to offer some pharmacologic advantage or a physician is familiar with a flammable anesthetic and unwilling to change technique). conductive flooring for this purpose is required to offer an average resistance of at least 25.

000 Ω. For convenience..000 Ω. especially if the power supply is changed from isolated to grounded. Conductive floors. or other conductive devices on furniture and equipment to ensure that they are free of wax. Avoid excessive lubrication. Conductive floors in nonflammable anesthetizing locations. Each of the five individual floor resistance readings should be no greater than 5 MΩ and no less than 10. The resistance between the metal plate 2 Inspection and Preventive Maintenance System ©1995 ECRI. if it does.000 Ω. . Lubricate casters if needed with dry graphite or graphited oil. and metal frame or chassis should not exceed 250. if a conductive floor is present. Inspect leg tips. However. Place the electrodes 3 ft apart on the floor.g. test the floor conductivity every month until the condition is corrected. or other mechanisms by placing one caster on a metal plate that is insulated from the floor. grounding jack. Measure the resistance at five different locations in the room. or other materials that interfere with conductivity. perform the entire inspection procedure. perform routine periodic tests of furniture and equipment conductivity by placing one of the 5 lb electrodes on the conductive floor and another on the furniture or equipment. Make sure that the floor is clean and dry.000 Ω or more to minimize electric shock risk from an excessively conductive floor.000 Ω.Inspection and Preventive Maintenance System measured. ECRI recommends treating or replacing floors to make them nonconductive. and the average resistance should be at least 25. must be inspected to ensure that each of the five floor-resistance measurements in each room yields a reading of 10. and average each set of five readings. we recommend testing all casters during initial acceptance testing of the device or furniture. Test conductive casters. casters. however. The resistance should not exceed 5 MΩ. Unplug the device (and remove any nonpermanent grounding straps). It is not necessary to record the resistance value. and the average should be no greater than 1 MΩ and at least 25. No further testing is required once this criterion is met. but space is provided on the form if it is desired in the event of a failure. 21⁄2″ diameter circular electrodes that meet the requirements of NFPA 99 Metal plate and insulating plate or sheet (for caster conductivity tests) Special precautions The megohmmeter used for this testing is capable of shocking personnel. No individual reading should be less than 10. lint. If the floor does not meet this criterion. since this can cause accumulations of oil and grime on caster wheels and sides. chains. grounded exposed metal in the room). Test apparatus and supplies High-voltage megohmmeter intended for this type of application. Procedure Equipment/Furniture. Conductive flooring is not required in nonflammable anesthetizing locations.000 Ω. Indicate on the form whether floor-to-frame or caster-to-frame tests were performed. Never touch the leads or equipment under test when the ohmmeter is activated.000 Ω. No further testing is required once the criterion is met. Each measurement from the floor to a ground point should be at least 10. Only one caster need meet this requirement to ensure continuity and to conform with NFPA 99. and measure and record the resistance between the two electrodes and from one electrode to a ground point (e. All Rights Reserved. which has an open-circuit voltage of 500 VDC and meets the requirements of NFPA 99 Two 5 lb. test as above. unless they are treated to make them nonconductive.

Conductive Furniture and Floors Inspection and Preventive Maintenance System ©1995 ECRI. 3 . All Rights Reserved.

. and anesthesia unit ventilators (see Procedure/Checklist 461) Risk Level: ECRI Recommended. Volume. Overview Mechanical ventilators are used to compensate for deficiencies in normal breathing. The ventilator provides direct control of the patient’s ventilatory variables. A pressure-cycled ventilator delivers gas until a predefined pressure is reached. and the limits on certain variables for safe operation. Pre-use checks should be performed by a respiratory therapist or respiratory equipment technician. When the ventilator’s 232575 458-0595 A NONPROFIT AGENCY 5200 Butler Pike. All these controls allow the clinician to provide better patient management. Intensive Care. Pressure-Cycled [14-360] Ventilators. Hospital Assessment. which may be related to hours of use. in that they are set to deliver a predefined volume of gas to the patient. Most infant ventilators are time cycled. Each subsystem requires its own inspection and preventive maintenance procedures. Many microprocessor-controlled ventilators have self-diagnostic programs. even for patients with serious respiratory impairments. Most adult ventilators are volume cycled. general medical/surgical units. . emergency departments Scope: Applies to all ventilators except jet ventilators. the concentration of inspired oxygen). portable ventilators (see Procedure/Checklist 471). as well as other variables (e.and time-cycled ventilators also have a pressure-limit control to prevent the attainment of dangerous pressures in the patient’s lungs. in that they are set to deliver gas for a predefined inspiratory time. Most modern ventilators use positive-pressure inflation of the lungs to accomplish these functions. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. Transport [18-098] Also Called: Respirators Commonly Used In: Critical care units. Plymouth Meeting.Procedure/Checklist 458-0595 Critical Care Ventilators Used For: Ventilators. A mechanical ventilator is composed of four basic subsystems: the ventilator and its controls. Ventilators are classified according to the method in which ventilation is accomplished. Neonatal/Pediatric [14-361] Ventilators. A ventilator may aid or augment spontaneous breathing or may completely regulate a prescribed breathing pattern for patients who cannot breathe for themselves. Intensive Care [17-429] Ventilators. gas supply.org .g. PA 19462-1298. hours hours * Inspection and preventive maintenance intervals should be scheduled according to the manufacturer’s recommendations. negative-pressure ventilators. units should have a major inspection at least every six months. monitors and alarms. However. and patient circuit (which includes the breathing circuit and may include a humidifier and nebulizer). Type Major Minor ECRI-Recommended Interval 6 months* NA Interval Used By Hospital months months Time Required . High.

Inspect the cord for signs of damage. Check the operation of brakes and swivel locks. 15:102-3. Be sure that plastic housings are intact. . 1986 Dec. enables easy production of customized procedures and checklists for specific ventilator models and clinical needs.) Circuit Breaker/Fuse. Examine the exterior of the unit for cleanliness and general physical condition. a separate checklist for use by outside vendors can be produced to ensure that those items agreed upon are performed by the vendor. If the line cord is detachable (by the user). Verify that they turn and swivel. 1983 Apr. check that it moves Test apparatus and supplies Lung simulator with adjustable compliance or ventilator tester Pressure gauge or meter with 2 cm H2O resolution from -20 to +120 cm H2O Various breathing circuit adapters Leakage current meter or electrical safety analyzer Ground resistance ohmmeter Additional items as required for specific manufacturers’ procedures 1. Leaving ventilator-dependent patients unattended [Hazard]. if the unit is so equipped. transducers) is checked by its own software. If any damage is suspected. Also. affix the cord to the unit so that it cannot be removed by the operator. (See Health Devices 1993 May-Jun. Examine the strain reliefs at both ends of the line cord. check the security of this attachment. if the damage is near one end. Be sure to wire a new power cord or plug with the correct polarity. AC Plug. and the alarm capabilities. Citations from Health Devices Inadequate pressure relief in infant ventilators [Hazard]. be sure that you understand how to operate the equipment. 15:323-4. Shake the plug and listen for rattles that could indicate loose screws.2 Procedure Before beginning an inspection. that all hardware is present and tight. In addition. Check the mounting security of all components or attached monitors. Microprocessor-controlled third-generation critical care ventilators [Evaluation]. Attempt to wiggle the blades to check that they are secure.1 Chassis/Housing. Remote alarms for ventilators and other life-support equipment. ventilation modes. Line Cord. solenoid valves. 1. 12:150-1. Examine the AC power plug for damage. If damaged. Mount/Fasteners.) 1. References to specific pages of the manufacturer’s manual should be added to the checklist. manual inspection items can be eliminated. cut out the defective portion. If the device has a switch-type circuit breaker. Manufacturers’ recommended procedures should be added where appropriate. Strain Reliefs. 18:59-83. 22:301-3. and that there are no signs of spilled liquids or other serious abuse. If the device moves on casters.. 1986 Apr. controls. If the device is mounted on a stand or cart. Be sure that they hold the cord securely.7 2 Inspection and Preventive Maintenance System ©1995 ECRI. open the plug and inspect it. 1989 Feb. and look for accumulations of lint and thread around the casters. If it is attached to a wall or rests on a shelf. Infant ventilators [Evaluation]. (The checklist includes blank spaces for the insertion of these page references. check line cords of battery chargers. The following framework should be supplemented by the manufacturer’s recommended preventive maintenance procedures for mechanical ventilators. carefully read this procedure and the manufacturer’s instruction and service manuals. 15:219-46. All Rights Reserved. the significance of each control and indicator. Manufacturers’ recommended procedures for inspection and preventive maintenance of mechanical ventilators vary in both methods and required accuracy.6 1. IPM Task ManagerTM. Casters/Brakes. check their condition.4 1. Items performed by outside vendors can be excluded from the checklist. Qualitative tests 1.Inspection and Preventive Maintenance System hardware (e. 1986 Aug. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. as appropriate.3 1. examine the condition of the mount.g.5 1. replace the entire cord or. the software component of the Inspection and Preventive Maintenance System. This procedure provides the basic framework for complete ventilator inspection and preventive maintenance. and algorithms for calculated variables vary greatly according to manufacturer and model.

for lead-acid batteries.4. which will prevent rotation or other strain. Induce alarm conditions to activate audible and visual alarms. Check the condition of all tubing and hoses. During the inspection. and correct motion. If any settings appear inordinate (e. All Rights Reserved.g.13 Controls/Switches. Before changing any controls or alarm limits.12 Filters. from Inspection and Preventive Maintenance System ©1995 ECRI. 1. If the unit has an alarm-silence feature.2 of the form. indicators. Confirm the operation of all lights. since some may require special conditions that must be established according to the manufacturer’s recommendations. pens). be sure to check that each control and switch performs its proper function. if present. 1.15 Fan/Compressor. The patient or caregiver should receive additional training. Check that any associated interlocks function. Cables. confirm that it does. Investigate questionable control settings on a home care unit. and note this on Lines 3. alarm limits at the ends of their range). Confirm appropriate volume. label it with the date.. and that keying is correct. or solid particle contaminants in the gas supply. Inspect any cables and their strain reliefs for general condition. advise appropriate personnel if found. check their positions.g. Examine all controls and switches for physical condition. and visual displays on the unit and charger (if so equipped). Check for automatic activation of the compressor when the piped gas supply pressure falls below operating pressure.14 Heater (for heated portions of the breathing circuit).. Verify that keyed connectors (e. Be sure that all segments of a digital display function. Clean or replace fan and/or compressor filters and lubricate as required. Check that control knobs have not slipped on their shafts. manual or automatic) against the manufacturer’s specifications. check for proper alignment. pin-indexed gas connectors) are used where appropriate. Consult with the patient’s physician to determine correct settings. When it is necessary to replace a battery. meters.17 Battery/Charger. fingernails. check the method of reset (i.g. Record the settings of those controls that should be returned to their original positions following the inspection. gauges. Check the physical condition and proper operation of the heater. Check for corrosion residue indicative of liquid. charge the battery. or dirty. 3 . Check operation of battery-operated power-loss alarms. as well as positive stopping.10 Fittings/Connectors. 1. Connectors to hospital central piped medical gas systems should have the appropriate DISS or quick-connect fitting to eliminate the need for adapters. gaseous.1 and 3. in fact.9 1. and indicate this on Lines 3. Check the condition of gas filters. 1. Examine all gas fittings and connectors for general condition. secure mounting.4 of the inspection form.21 Audible Signals. that all pins are in place and secure. if so equipped. 1. Where appropriate. Check membrane switches for damage (e..20 Alarms/Interlocks. check its value and type against that marked on the chassis and ensure that a spare is provided. (The inspection can be carried out on battery power to help confirm adequate battery capacity. 1. Inspect the physical condition of batteries and battery connectors if readily accessible. to the extent possible. Operate the unit on battery power for several minutes to check that the battery is charged and can hold a charge. include these in Item 2. Where a control should operate against fixed-limit stops.) Check battery condition by activating the battery test function or measuring the output voltage. consider the possibility of inappropriate clinical use or of incipient device failure.1 and 3.18 Indicators/Displays. 1. 1. kinked. Check the physical condition and proper operation of these components.Critical Care Ventilators freely. according to the manufacturer’s instructions. Verify alarm messages on displays. 1. verify that there are no intermittent faults by flexing cables near each end and looking for erratic operation or by using an ohmmeter. Carefully examine cables to detect breaks in the insulation and to ensure that they are securely gripped in the connectors at each end. 1. if required. Record reading of an hour meter. Clean or replace if appropriate. Be sure that they are not cracked.. Gas fittings should be tight and should not leak. measure the specific gravity and check the fluid level. Check the condition of the battery charger and. Operate the device to activate any audible signals.e. Be sure that the battery is recharged or charging when the inspection is complete. It may not be possible to check out all alarms at this time. Verify that the remote alarm indicator functions properly.8 Tubes/Hoses. If the device is protected by an external fuse.

Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Chassis leakage current to ground should not exceed 300 µA. 2. Confirm the presence and condition of accessories. may include tidal volume. if so equipped. 2. 1. This includes other equipment that is plugged into the primary device’s accessory receptacles.g. flow. 2. gauges.. securely mounted.5 Ω. among others. inspiratory time) at which to verify proper operation and accuracy (generally within 10%). and in good condition and that there is adequate gas supply. or multimeter with good resolution of fractional ohms. We recommend a maximum of 0. low MAP. inspiratory time.3 Modes and Settings. alert clinical staff to the importance of keeping alarms at the appropriate level. Breathing circuit (including filters). respiration rate. and off..6 Patient Circuit. Using an ohmmeter. 1. Gas cylinders. Quantitative tests 2. and/or volume and time to settings on the ventilator. Verify that appropriate gas-specific connectors are used. flow. If audible alarms have been silenced or the volume set too low. and record the maximum leakage current. see Oxygen Analyzers Procedure/Checklist 417 Temperature of inspired air Other monitors Alarm settings (e. All Rights Reserved.5 Gas Supply. expiratory time. tidal volume. The manufacturer should recommend the appropriate ventilator settings (e. inspiratory:expiratory (I:E) ratio. including the humidifier and the nebulizer (see Procedure/Checklist 431 for heated humidifiers). as well as equipment plugged into a multiple-outlet strip (“Waber strip”) so that all are grounded through a single line or extension cord. Oxygen-air proportioner.1 Grounding Resistance. measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. electrical safety analyzer. assist/control. If the system is modular or composed of separate components.g.2 4 Inspection and Preventive Maintenance System ©1995 ECRI. Verify that these components are compatible with the ventilator according to the manufacturer’s recommendations (see Health Devices 1988 2. The following parameters are commonly monitored and should be inspected for accuracy (generally within 10%) according to the manufacturer’s specifications: Breathing rate Inspiratory time Peak inspiratory pressure (PIP) Peak or mean inspiratory flow PEEP Mean airway pressure (MAP) Volume (both tidal and minute volume) Fraction of inspired oxygen (FIO2). Leakage Current. Check the accuracy of flowmeters on infant ventilators. The function of these modes should be inspected and verified for proper operation. Operate the device in all normal modes. high PIP. labels. rate. including on. The following modes are commonly found on most ventilators: control. Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off. Verify that these components are present. and continuous positive airway pressure/positive end-exhalation pressure (CPAP/PEEP). . these tests are performed by attaching the ventilator to a lung simulator or ventilator tester and comparing measured values of pressure.Inspection and Preventive Maintenance System as well as the operation of a volume control. which 2. low FIO2) should be inspected for proper and accurate activation. standby. Compressor.4 Monitors and Alarms. Pneumatic lines (including air filters). Test according to the manufacturer’s recommendations. Check that all necessary placards. 2. intermittent mandatory ventilation/synchronized intermittent mandatory ventilation (IMV/SIMV). and instruction cards are present and legible. pressure support. and regulators (for transport ventilators). and waveshape.23 Accessories. verify grounding of the mainframe and each module or component. Typically.22 Labeling. Check the operation and accuracy of ventilation controls. See Procedure/Checklist 444. low pressure.

Set alarms loud enough to alert personnel in the area in which the device will be used. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. ensuring that fittings. 5 . if needed. nebulizers) are properly assembled and functioning correctly. Inspection and Preventive Maintenance System ©1995 ECRI. and other components (e. Before returning to use Ensure that all controls are set properly.1 3. Check for leaks in the breathing circuit. 3. Recharge battery-powered devices. Check the proper operation of the pressure-relief mechanism by occluding the breathing circuit and measuring the resulting peak pressure on the pressure gauge. and components if needed.3 Clean the exterior. Humidifiers.Critical Care Ventilators Apr. interior. See Heated Humidifiers Procedure/Checklist 431. Verify that pressure is vented in the breathing circuit. adapters. water traps. exhalation valves. Other controls should be in their normal pre-use positions.. 17:109). 4. or equip them with fresh batteries. All Rights Reserved. Pressure-relief Mechanism. Attach a Caution tag in a prominent position so that the user will be aware that control settings may have been changed. ensure that controls are set correctly before it is returned to the patient. H-valves.g. If the unit is being used at home. Calibrate according to the manufacturer’s instructions. PEEP valves. 3. Preventive maintenance 3.4 Replace components according to the manufacturer’s instructions.

Hospital Assessment. Cryogen flows through an insulated probe shaft. respectively. lowers the tip temperature to near the boiling point of the cryogen.. Liquid nitrogen CSUs deliver the cryogen to the tip as a liquid.g. N2O and CO2 units are most suitable for benign and inflammatory diseases. Liquid nitrogen units can attain temperatures as low as -196°C and are suitable for both benign and malignant tumors. The advantages of cryosurgery for tissue destruction include ease of use. Cryosurgically treated tissue is usually allowed to become necrotic and slough off. gynecology. surgical clinics Scope: Applies to all cryosurgical units. otolaryngology. most units have a wide range of applications and associated interchangeable tips. the lowest probe-tip temperatures they can attain are -89° and -79°C. Plymouth Meeting. proctology. in which a compressed gas (often at or near room temperature) is allowed to expand suddenly through a small aperture inside the probe tip. and relatively few postoperative complications. PA 19462-1298. The two types of CSUs — those that use liquid nitrogen and those that use N2O or CO2 — have significantly different freezing capabilities. cooling occurs through the Joule-Thompson effect.org . hours hours Overview Cryosurgical units (CSUs) apply a gaseous or liquid refrigerant (cryogen) to freeze target tissue either through direct application of liquid cryogen (open-system CSUs) or indirectly through contact with a cryogen-cooled probe (closed-system CSUs). and dermatology professional offices. except disposable ophthalmic cryoextractors.Procedure/Checklist 457-0595 Cryosurgical Units Used For: Cryometers [11-066] Cryosurgical Units [11-067] Cryosurgical Units. where its rapid vaporization cools the probe. Ophthalmic [11-068] Also Called: CSUs Commonly Used In: Operating rooms. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. oral surgery. In closed-system N2O units and CO2 units. although they have been used successfully to treat small malignancies. portions of this procedure are applicable to tissue-temperature and tissue-impedance cryometers that may be integral to a CSU Risk Level: ECRI Recommended. and exhausts back through the probe (closed-system design) or is applied directly to the 085109 457-0595 A NONPROFIT AGENCY 5200 Butler Pike. Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . Medium. ophthalmology. the avoidance of hemorrhage. gynecology). urology. ophthalmology. and proctology. urology. Cryosurgery is used in dermatology. cooling the tip. Although some CSUs and their probe tips are designed for use within only one specialty (e. causing a considerable drop in gas temperature and liquefaction of some of the cryogen. OB/GYN. combined with the drop in gas temperature caused by expansion. . The vaporization of the liquefied cryogen from the interior of the tip. the need for little or no anesthesia.

To ensure that the unit is freezing properly. the unit may be equipped with an impedance cryometer. the probe tips on many console CSUs contain a cryometer (usually incorporating a thermocouple) to measure probe-tip temperature. the units operate at very high pressures. the equipment needed to safely service and inspect CSUs is expensive. a more acute concern for their safety during the inspection is to guard against temporary N2O intoxication. exhaust occlusion (resulting in gas pressure buildup in the tip that causes the cryogen to heat up). Some console CSUs also have a tissue-temperature cryometer. hypodermic thermocouples are used to monitor the target-tissue temperature. Scavenging exhausted N2O from CSUs is essential. away from air-intake ducts. Most older N2O CSUs expose personnel to levels well in excess of the 25 parts per million time-weighted average concentration limit of N2O gas recommended by the National Institute of Occupational Safety and Health (NIOSH). . If an unscavenged N2O CSU must be used while awaiting proper scavenging modifications or before switching to a CO2 CSU. and operating controls. We recommend switching to CO2 as the cryogen. near the ceiling]). Questions have arisen over whether it is advisable. N2O units that cannot be scavenged or converted for use with CO2 should be removed from use and only CO2 units purchased. Alternatively. drain trap. and handheld. so the total quantity of N2O used during a cryosurgical procedure or inspection is substantial and potentially very dangerous. which uses hypodermic needle electrodes to assess the extent of freeze. Because exposure of clinical engineering personnel to the gas will be only occasional. However. does not directly reflect the cryolesion temperature and is not used as the definitive indicator of the depth and temperature of the frozen tissue. and the exposed hose end should be equipped with a connector appropriate for attachment to the exhaust hose. usually within seconds. Gun-type and pencil-shaped probes attach to both console and stand-alone units. stand-alone. Alternatively. increased incidence of hepatic and renal disorders. Liquid nitrogen CSUs can be either open or closed. one end of the exhaust hose should be placed 1 to 2 ft into the room air exhaust vent (permanent installation of a short length of exhaust hose through the vent grill is advisable if vents are inconveniently located [e. the manufacturer or a local supplier can probably order the proper size and type of exhaust hose for equipment with an N2O scavenging port. and undetected probe damage can result in explosion and serious patient injury. the hospital must scavenge all N2O from CSUs and vent it to the outside. portable CSUs that use liquid nitrogen as the cryogen. N2O is both teratogenic and mutagenic. practical. Facilities that can operate with either N2O or CO2 should strongly consider using CO2 — even if scavenging is possible — because it is intrinsically safer. Consoles are freestanding units that typically contain the cryogen gas cylinders. such as a hospital 2 Inspection and Preventive Maintenance System ©1995 ECRI. clinical engineering staff should perform annual routine general equipment inspections to detect any impending problem or improper scavenging of exhausted N2O. Furthermore.Inspection and Preventive Maintenance System target tissue (open-system design). Active defrosting warms the probe from within and allows the tip to be removed safely and quickly. We do not recommend such a practice. This reading. In addition. or gas flooding of the tip with low-pressure cryogen at room temperature. All Rights Reserved. N2O can be vented to the outside through a window or small hole drilled in the window frame or the wall of the room where the equipment is used. CO2 should be used for CSUs if scavenged N2O cannot be safely or conveniently vented or if N2O cannot be scavenged because of the design of the CSU. For treatment rooms in clinics and offices (and for ORs where the N2O cannot be vented as discussed above). it can be achieved using an electric heater within the probe tip.. or the piped medical/surgical suction system. or safe for a hospital to repair its own cryosurgical equipment. An N2O CSU should not be used or tested unless its exhaust is properly scavenged.5 ft3/min). the flow of gas from CSUs is much higher than that from anesthesia machines. the N2O exhaust can be vented through this system rather than the return air system if it is more convenient. however. the reported long-term hazards of exposure to this and other anesthetic gases include increased rate of spontaneous abortion. Users should contact the manufacturer of their unit and request information on scavenging the N2O exhaust. and cancer. Handheld units are lightweight. N2O should never be vented into a sink. it should be used in an extremely well-ventilated area. Most closed-system CSUs have active defrosting of the probe tip to allow its safe and rapid removal from the target tissue. indicators. CSUs are available in three basic configurations: console. pressure regulators. If an N2O CSU is used in an OR with 100% outside air ventilation. If the OR has a dedicated system for venting scavenged anesthetic gases with a flow capacity 100 L/min (3. CSUs using N2O or CO2 are not usually suitable for use as open systems because cryogen “snow” builds up on target tissue and insulates the lesion from the cryogen spray. Stand-alone units are freestanding cryogen tanks on carts without controls or displays.g.

Gas cylinder mounts should securely fasten the cylinders to the CSU stand or console. If the device is mounted on a stand or cart. 18:86. that all hardware is present and tight. If any damage is suspected. If the device has electrical receptacles for accessories. Shake the plug and listen for rattles that could indicate loose screws. we have included tests for electrical safety and special functions for use on those units that are so equipped. First. Personnel exposure to waste anesthetic gases. N2O cryosurgical units must be scavenged [Hazard update]. carefully read this procedure and the manufacturer’s instruction and service manuals. Check the operation of brakes and swivel locks. If Test apparatus and supplies Leakage current meter or electrical safety analyzer Ground resistance ohmmeter 10× loupe Stopwatch or watch with a second hand Cup filled with tap water (temperature not critical) 1. verify presence of line power. Frigitronics Model CCS-100 cryosurgical cart [User Experience NetworkTM]. examine the condition of the mount. Procedure Before beginning an inspection. Be sure that plastic housings are intact. 1986 Dec. Then. make sure that the valve is not pointed toward anyone. 1986 Jan. Qualitative tests 1. liquid N2O tanks are usually blue with a silver neck. the significance of each control and indicator. 1987 Dec. 8:293.3 Inspection and Preventive Maintenance System ©1995 ECRI. 1989 Feb.2 Special precautions Liquid nitrogen must be handled with care to prevent operator injury. Siphon gas cylinders and cryosurgical units [Hazard]. Siphon-type gas cylinders used with liquid N2O CSUs can be mistakenly installed on a CSU designed for gaseous N2O use if the cylinders are mislabeled or if medical personnel are unaware that siphon cylinders should not be used with gas units. Verify that they turn and swivel. 3 . 15:24. gaseous N2O tanks are entirely blue. 1980 May. If a siphon cylinder is fitted to a gas unit. All cylinders should be tested before they are connected to the CSU. AC Plug/Receptacles. insert an AC plug into each and check that it is held firmly. and look for accumulations of lint and thread around the casters. If the device moves on casters. 12:169-77. resulting in patient or operator injury. Update: Nitrous oxide exhausted from cryosurgical units. the cylinder contains a siphon and should be used only with CSUs specified for liquid N2O use. 1979 Oct. 15:332-3. check their condition. 16:407-9. no mist should be seen. and the alarm capabilities. if the unit is so equipped. and that there are no signs of spilled liquids or other serious abuse. All N2O CSUs must have their exhaust safely scavenged during inspections to prevent acute physical and psychological impairment and possible long-term adverse health effects to the inspector. Examine the AC power plug for damage. 9:187. All Rights Reserved. Should hospitals repair cryosurgical units? [User Experience NetworkTM]. Surgical devices omitted from equipment control programs [Hazard]. Very few N2O CSUs are designed to accept siphon cylinders of liquid N2O. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. 9:180. Although many CSUs are gas powered. Casters/Brakes.4 1. Read and follow the precautions and warnings for handling liquid nitrogen presented in the equipment manual for any CSU using this cryogen.1 Chassis/Housing. Citations from Health Devices Nitrous oxide exhausted from cryosurgical units [Hazard].Cryosurgical Units operating room. Examine the exterior of the unit for cleanliness and general physical condition. States. check the security of this attachment. open the valve one half to one full turn for 2 to 4 sec. Mount/Fasteners. If it is attached to a wall or rests on a shelf. 1980 May. 1. Attempt to wiggle the blades to check that they are secure. open the plug and inspect it. as appropriate. liquid N2O can leak from the fittings or seals of the cryoprobe. In the United 1. be sure that you understand how to operate the equipment. Pregnant staff members should never be present during use or testing of an unscavenged N2O CSU. 1983 May. If a continuous mist is observed.

replace the entire cord or.g. Examine the probe shaft thermal insulation for cracks or signs of degradation. They should not have any cracks. This will minimize the chance of high-pressure leaks. consider a full inspection of the receptacles. .13 Controls/Switches. Examine all gas and liquid fittings and connectors.17 Battery/Charger. Be sure to wire a new power cord or plug with the correct polarity. label it with the date. If the device has a switch-type circuit breaker. Operate the unit for about 30 sec with each tip immersed in water (water temperature is not critical) and check to make sure that ice forms on the tip. During the course of the inspection. kinked. be sure to check that each control and switch performs its proper function. Cables.10 Fittings/Connectors. remote control) and their strain reliefs for general condition. Confirm that appropriate probes and probe tips are on hand and check their physical condition. 1. Check the condition of all liquid and gas (air) filters.12 Filters. cut out the defective portion.6 1.. If damaged. If a yoke has no keying pins — which some manufacturers have omitted. from fingernails. 22[5-6]:301-3. 1. Inspect the cord for signs of damage. confirm that it does in fact charge the battery. When it is necessary to replace a battery. electrode. Also check line cords of battery chargers. consider the possibility of inappropriate clinical use or of incipient device failure. check that it moves freely. Inspect the physical condition of batteries and battery connectors if readily accessible. check for proper alignment. or evidence of bending. as well as electrical cable connectors. Be sure that they are not cracked. Before changing any controls or alarm limits. as well as positive stopping. Make sure that no keying pins are missing and that the keying is correct for the gas that is used. Check the condition of all tubing and hoses. 1. Verify that there are no intermittent faults by flexing electrical cables near each end and looking for erratic operation or by using an ohmmeter. Clean or replace as appropriate and indicate this on Lines 3. Also. The presence of such damage suggests that these delicate probes have been bent or crushed and must be replaced. If any settings appear inordinate. if present. make sure that users turn off the gas cylinder valves between uses. for general condition.11 Probes and Probe Tips. corrosion. Complaints of excessive gas usage indicate that the CSU may have a leak between the cryogen gas cylinder and the console/regulator. if the damage is near one end. abrasion.9 1. (See Health Devices 1993 MayJun. and ensure that a spare is provided.Inspection and Preventive Maintenance System accessories are plugged and unplugged often. Pin-indexed gas cylinder yokes should be present. listen for audible leaks and look for dripping cryogen. and. cepted safety standards — immediately replace the yoke with one correctly keyed for that gas. For ophthalmic probe tips. 1. Carefully examine cables to detect breaks in the insulation and to ensure that they are gripped securely in the connectors at each end to prevent rotation or other strain. check their positions. Where a control should operate against fixed-limit stops. Tubes/Hoses.) Circuit Breaker/Fuse. If the device is protected by an external fuse. we recommend that the cord be affixed to the unit so that it cannot be removed by the operator. Examine all controls and switches for physical condition. and bright. 1. or dirty. check its value and type against that marked on the chassis. Gas and liquid fittings should be tight and should not leak.5 Line Cord. Examine the strain reliefs at both ends of the line cord. in violation of ac- 4 Inspection and Preventive Maintenance System ©1995 ECRI. make sure that there is no leakage of cryogen (seen as bubbles in the water) from the probe/tip connector.8 1. kinks. Strain Reliefs. Verify that leads and hoses are firmly gripped in their appropriate connectors. Check membrane switches for membrane damage (e. Destroy and discard the unkeyed yoke. including battery-operated cryometers. pens).4 of the inspection form. During each tip test. use a 10× loupe to inspect them. dents.1 and 3.. Be sure that they hold the cord securely. If the line cord is detachable (by the user). Check the condition of the battery charger. 1. All Rights Reserved. Electrical contact pins or surfaces should be straight. clean.g.7 1. secure mounting. and correct motion. Check that control knobs have not slipped on their shafts. Inspect any cables (e. to the extent possible. Record the settings of those controls that should be returned to their original positions following the inspection. sensor.

5 Ω. manual or automatic) against the manufacturer’s specifications.24 Defrost Control. if needed. electrical safety analyzer. confirm the operation of all lights. Check that all necessary placards.4 Clean exterior (interior if appropriate). 5 .19 User Calibration. Set alarms loud enough to alert personnel in the area in which the device will be used. Check that gas pressure gauges and flowmeters read zero when the gas is not turned on. 1. 1. if present. Be sure that all segments of a digital display function. Verify that the defrost feature operates. Tissue-Temperature Cryometer.22 Labeling. The ice ball should release from the probe tip when the tip temperature readout indicates 0°C. The tissue-temperature probe and probe tip will freeze within the ice ball. Using an ohmmeter. as well as the operation of a volume control. labels. Quantitative tests 2. Touch a tissuetemperature probe to the probe tip and immerse them both in water. Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off. indicators.4 2. An N2O CSU should not be used or tested unless its exhaust is properly scavenged. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. Confirm appropriate volume. 2.20 Alarms. since some may require abnormal operating conditions that will be simulated later in this procedure. Other controls should be in their normal pre-use positions. Before returning to use Make sure that all controls are set properly.2 Leakage Current. grounding resistance need not be measured. Operate the device to activate any audible signals. verify grounding of the mainframe and each module or component. Check that any associated interlocks function. 1. Repeat the defrost control test described in Item 1. verify the accuracy of a timing mechanism with a stopwatch or watch with a second hand for 5 min. It may not be possible to check all alarms at this time. Chassis leakage current to ground should not exceed 300 µA. check its grounding to the main power cord. and off. Preventive maintenance 3. For N2O CSUs. and record the maximum leakage current. verify the presence of a scavenging attachment and hose. If the device is double insulated.21 Audible Signals.5 3. including on. if needed.3 3. We recommend a maximum of 0. If the CSU console has an accessory receptacle. Operate the device in all normal modes. Be sure that the inspection did not deplete the cryogen supply to a level that disables the unit. Record reading of an hour meter. Elapsed-Time Meter/Timer. During the course of the inspection. 2.. Verify that the self-test function operates and indicates normal operation. Calibrate cryometer.3 Probe-Tip Cryometer. An ice ball on a tip should dislodge within approximately 30 sec after activation of the defrost mode. gauges. 1. measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. or multimeter with good resolution of fractional ohms. 4. Turn off the cryogen gas cylinder valves after completing the inspection.1 Grounding Resistance. Where present. if so equipped.25 Scavenger. and instruction cards are present and legible. and visual displays on the unit. All Rights Reserved. Induce alarm conditions to activate audible and visual alarms. check the method of reset (e.18 Indicators/Displays. indicate “DI” instead of the ground resistance value. Replace probe-tip O-rings. standby. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. conversion charts. Activate the CSU at its maximum freezing power (if adjustable) for approximately 3 min.g. If the system is modular or composed of separate components. The error should not exceed 10 sec. 1. Inspection and Preventive Maintenance System ©1995 ECRI.24. If the unit has an alarm-silence feature.Cryosurgical Units 1. if so equipped. 2.1 3. meters. ±1°C. The tissue temperature and probe-tip temperature should be within 5°C of each other. 2. 1.

In addition to periodic inspections. Line-Powered [15-029] Defibrillator/Monitor/Pacemakers [17-882] Commonly Used In: Coronary and special care areas. or depleted or defective batteries (the most common cause of defibrillator failure with battery-powered units).org . Failure to successfully defibrillate a patient may occur for a number of reasons. 16:183-216. External Noninvasive Procedure 460 for units with this accessory Risk Level: ECRI Recommended. High. hours hours Overview Defibrillator/monitors combine the functions of an ECG monitor and defibrillator into a single unit. 1986 Dec. Most units are battery-powered so that they can be used during transport within a hospital or in an ambulance or carried into the field. including inadequate predefibrillation cardiopulmonary resuscitation (CPR) technique. poor paddle application). resuscitation carts.) Mains (AC Line) power switches on battery-powered equipment [Hazard]. operator error (e.. PA 19462-1298. patient care areas Scope: Applies to battery. if appropriate. since every minute of delay significantly decreases the probability of a successful resuscitation attempt. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. 1987 Sep-Oct. 16:345.g. Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . Hospital Assessment. which allows the operator to quickly assess and monitor the ECG and apply a defibrillating pulse. 009020 408-0595 A NONPROFIT AGENCY 5200 Butler Pike. Citations from Health Devices User error and defibrillator discharge failures [Hazard]. They should also perform discharge testing at least once a week. 1987 Jun. emergency departments. 22:291-2. operating rooms. does not apply to defibrillators or ECG monitors (see Defibrillators Procedure/Checklist 407 and ECG Monitors Procedure/Checklist 409). A User Checklist for Defibrillators/Monitors/Pacemakers is included in Health Devices 1993 May-Jun.and line-powered defibrillator/monitors. There is no time to troubleshoot or correct even minor difficulties during emergencies. Plymouth Meeting. 16:251. see Pacemakers. (See also 1987 Jul. 16:55. Battery-powered defibrillator/monitors [Evaluation]. ambulances. Defibrillator/monitors are critical resuscitation instruments. 15:340. 1987 Feb.Procedure/Checklist 408-0595 Defibrillator/Monitors Used For: Defibrillator/Monitors. Defibrillator paddle resistance (continuity) testing [User Experience NetworkTM]. Deteriorating insulation on internal defibrillator paddles [Hazard]. Their failure to perform effectively may result in the death of a patient undergoing resuscitation or cause further cardiac damage or even death in a patient undergoing elective cardioversion or emergency cardioversion of a life-threatening arrhythmia. clinical staff should perform visual inspections and ensure that batteries are charging at the beginning of each work shift and after each use of the device. 16:46. . 1987 Feb.

18:84. Alarm lockup on ZMI PD 1200 defibrillator/monitors [Hazard]. 1992 Jun-Jul. 16:389. Overheating of replacement batteries in Physio-Control Lifepak 6. 1992 May. 1991 Mar-Apr. A second person must be present to summon help and/or apply CPR in the event of an emergency. 17:68. 22:595-7. 1988 Nov. 1991 Dec. 19:293-4. 1990 Feb. 20:497-8. 1989 Jun. Physio-Control Lifepak 6 and 6s defibrillator/monitors [Hazard]. 19:33-56. 1993 Dec. 1988 Feb. All Rights Reserved. Defibrillator/monitors and external noninvasive pacemakers [Evaluation Update]. Fires from defibrillation during oxygen administration [Hazard]. 1990 Feb. 1994 Jul. 1989 Feb. 1994 Aug-Sep. and 7 defibrillator/monitors [Hazard Update]. Physio-Control Lifepak 10 defibrillator/monitor Sync mode [User Experience NetworkTM]. 1993 May-Jun. Hewlett-Packard defibrillator/monitors and Darox R2 electrodes [User Experience NetworkTM]. Never perform tests alone. 23:374-5. Disposable difibrillator pads and electrodes [Evaluation]. 1988 Aug. Lifepak 8 defibrillator/monitors [Hazard]. Difficulty synchronizing with Zoll PD 1200 defibrillator/monitor/pacemaker [User Experience NetworkTM]. 1994 Mar. Misalignment of mating cable and defib cassette connectors on Physio-Control Lifepak 8 defibrillator/monitor [Hazard]. 17:245. 22:212-94. Porta Fib III defibrillator/monitor paddles [Hazard]. 20:141. 23:455-6. Physio-Control develops Mains Power switch cover [Hazard Update]. 21:250. Internal defibrillator paddles [User Experience NetworkTM]. 1991 Jan.Inspection and Preventive Maintenance System Battery-powered defibrillator/monitors [Evaluation Update]. 23:307-9. 23:98-9. Use of Physio-Control Lifepak 8 defibrillator/monitors with optional QUIK-PACE pacing cassette [User Experience NetworkTM]. 1987 Dec. . Battery pins on Lifepak 5 defibrillator/monitors [Hazard]. Misuse of “Quick Look” defibrillator paddles [Hazard]. 1993 Dec. Maintenance and user errors with the Physio-Control Lifepak 8 [User Experience NetworkTM]. Sparking during discharge testing on Physio-Control Lifepak 9 defibrillator/monitors [User Experience NetworkTM]. Spontaneous charging of Hewlett-Packard 43100A defibrillator/monitor used with anterior/posterior paddle set during monopolar electrosurgery [Hazard]. 1988 Sep. 6s. 17:356. 22:579-82. 1990 Dec. 1994 Oct-Nov. 19:59. 17:273. 19:455-6. 18:175. Replacement batteries for the Physio-Control Lifepak 6 and 7 [User Experience NetworkTM]. 1990 Aug. 1989 May. 19:61. 19:246. 20:30-1. Defibrillator/monitors and external noninvasive pacemakers [Evaluation]. 17:244. Heart-rate alarms on ZMI ZOLL PD 1200 pacemaker/defibrillators [Hazard]. ECG artifact and defibrillator/monitors [User Experience NetworkTM]. 18:233. 21:183. Never hold or contact the conductive electrode portion of the paddles 2 Inspection and Preventive Maintenance System ©1995 ECRI. 1990 Feb. Lifepak 8 defibrillator/monitors [Hazard Update]. Test apparatus and supplies Defibrillator analyzer ECG simulator (calibrated output amplitudes and rates are required for some tests) Ground resistance ohmmeter Leakage current meter or electrical safety analyzer Stopwatch or watch with a second hand The following equipment is necessary during acceptance testing only: Function generator Attenuator Oscilloscope Transparent metric scale Isolation test supply (included in some electrical safety analyzers) Special precautions CAUTION: The high voltage present on defibrillator paddles during discharge is extremely dangerous and possibly lethal. 1990 Jul. Mismatch of CCP R2 181-239 cables and HP43100 defibrillators [Hazard]. 1988 Aug.

Check the operation of brakes and swivel locks. Mount. Examine the strain reliefs at both ends of the line cord. damaged receptacles. Electrical contact pins or surfaces should be straight and clean.5 Line Cord. these are equivalent units (i. If any damage is suspected. Wiggle. 3 .7 1. 1. and ensure that a spare is provided. Be sure that plastic housings are intact. replace the entire cord. if appropriate) for signs of damage.e. If the device has a switch-type circuit breaker.. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. and be sure that they turn and swivel. if the unit is so equipped. Circuit Breaker/Fuse. Defibrillator energies may be specified in either joules (J) or watt-seconds. If damaged. Testing input isolation requires the use of a line voltage source. Examine the AC power plug for damage. check the security of this attachment. and check that it holds firmly. perform the inspection in the vicinity of the unit’s usual storage location. Verify that an ECG can be displayed with either paddles or ECG leads used as input. and carbon deposits from arcing. Strain Reliefs. Do not test all the units in an area at one time. 1. If the device moves on casters. and pull the cable to check that continuity is not affected. check that it moves freely.9 1. Qualitative tests 1. During major inspections. use caution to avoid contact with any portion of the circuit while it is energized. including testing for wiring (e. be sure that you understand how to operate the equipment. Look for accumulation of lint and thread around the casters.2 1. Be sure that they hold the cord securely.4 AC Plug. examine the condition of the mount. or ensure that a unit that the clinical staff is familiar with is available as a substitute.3 1. If the device is mounted on a stand or cart. If it is attached to a wall or rests on a shelf.10 Fittings/Connectors.6 1. the significance of each control and indicator. Inspect the cables of internal and external paddles. open the plug and inspect it. Shake the plug and listen for rattles that could indicate loose screws. Inspection testing may deplete the battery of battery-powered units. disposable defibrillation electrodes (if applicable). All Rights Reserved. Cables. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors at each end to prevent rotation or other strain. bend. disconnect the paddle connectors and look for misaligned pins. 1. Ensure that a replacement unit or a fully charged battery is available before you begin testing. and that there are no signs of spilled liquids or other serious abuse. Verify that leads and electrodes are firmly gripped in their appropriate connectors. Be sure to wire a new power cord or plug with the same polarity as the old one. Examine the exterior of the unit for cleanliness and general physical condition. using an outlet tester) and tension of all three connections. Thus. that all assembly hardware is present and tight.. Casters/Brakes.g. and the alarm capabilities.1 Chassis/Housing. Inspect the cord (including resuscitation cart line cord. Inspect resuscitation cart receptacles. 1. carefully read this procedure and the manufacturer’s instruction and service manuals. and ECG electrodes for their strain reliefs and general condition. as appropriate. Check line cords of battery chargers. Procedure Before beginning an inspection. cut out the defective portion. insert an AC plug into each. Also inspect the resuscitation cart plug for damage as described above. since this will leave the staff inadequately equipped to handle emergencies. Attempt to wiggle the blades to determine that they are secure. check their condition. Examine all cable connectors for general condition. Although this source should include a current-limiting resistor. If the device is protected by an external fuse.Defibrillator/Monitors unless you have confirmed that the defibrillator is disarmed (not charged) and preferably off. If the device is mounted on a cart that has electrical receptacles for additional equipment. check its value and type against that marked on the chassis. Inspection and Preventive Maintenance System ©1995 ECRI. A defibrillator/monitor must always be available in the event of an emergency during the inspection. 1 J = 1 watt-second). or if the damage is near one end.

g. making the ECG difficult to see. if appropriate. Be sure that all segments of a digital display function.. If the monitor can be separated from the defibrillator. All portions of a simulated ECG waveform should be clear and visible. and charging light is on). ensure that both controls function properly. and visual displays on the unit and charger.e. Clean the paddles. If the manufacturer recommends this procedure. control the ambient light or use a filter over the display. A front-panel discharge button should control only internal paddles (or disposable defibrillator electrodes. When it is necessary to replace a battery. Ambient light should not affect the visibility of the trace. indicators. During the course of the inspection. secure mounting.g. If the unit has redundant control functions (e. Check membrane switches for membrane damage (e.. and correct motion.. Where a control should operate against fixed-limit stops. make sure that it is securely connected to the defibrillator. Some batteries require periodic deep discharges and recharging to maintain maximum battery capacity. (If monitors are located so that ambient light reflects from the face of the display.Inspection and Preventive Maintenance System 1. Check battery capacity by activating the battery test function or measuring the battery-powered operating time. Confirm that special paddles (e. The baseline should be horizontal and should not be noticeably sloped or bowed. pediatric.17 Battery/Charger.) 4 Inspection and Preventive Maintenance System ©1995 ECRI. The pulses from an ECG simulator should be regularly spaced (uneven spacing indicates a sweep nonlinearity). Verify that activating just one paddle discharge button will not cause the unit to discharge. the baseline should be correctly positioned. a charge button on the front panel and on a paddle). physiologic fluids. verify that the batteries are properly installed and that the charging. Verify that the charger of battery-operated units is plugged into a live AC outlet and that the charger is attached to the defibrillator (i. All Rights Reserved. check for proper alignment as well as positive stopping. Observe a simulated ECG signal on the display. Inform clinical personnel of any deficiencies so that problems can be avoided in the future. label it with the date. verify that it is being performed on schedule. and make sure that they are completely dry before proceeding with any further testing. light is on. if needed. 1. Examine all controls and switches for physical condition. confirm the operation of all lights. if readily accessible.g.11 Paddles/Electrodes.g. Dirty electrodes prevent good electrical contact and can cause burns. Perform the inspection with the unit on battery power to check that monitor and defibrillator batteries are charged and can hold a charge. unit is firmly seated into charging stand or mount. charger cable is attached.. disposable difibrillation electrodes) are available. 1. Confirm that an adequate supply of ECG electrodes and disposable defibrillation electrodes (if used) are available and that they are stored properly and are within their expiration dates. instrument end of line cord is attached. the baseline should move throughout most of the vertical height of the display. During the course of the inspection. internal) and electrodes (e. on some units) and should not cause discharge when external paddles are connected. When the vertical position of the baseline is varied by adjusting the vertical position control. In monitors that incorporate a self-centering baseline and therefore lack a position control. Examine all paddles for physical condition and cleanliness. check that each control and switch performs its proper function. or debris on the paddle surface or handles.18 Indicators/Displays. There should be no distortion in the baseline as it is moved up or down on the screen. meters. and verify compliance with the following criteria: The baseline should stay in focus across the display. from fingernails. including the P-wave and QRS. including the electrode surface and handle seams.13 Controls/Switches. pens). or ready. Electrode gel or other debris on the insulating portion of the paddle can cause operator shocks. . For units with removeable batteries that are charged in a separate charger. Alert clinical personnel responsible for the instrument to the presence of dried electrode gel. 1. Inspect the physical condition of batteries and battery connectors..

After 1 to 2 sec. not skin lubricant or ultrasound or TENS gel. Check that all necessary placards. If the unit also has a front-panel button for this purpose. Sag time is measured to the half-amplitude point.22 Labeling. compare the amplitude of the internal calibration pulse and an external 1 mV signal (from a calibrated ECG simulator). Figure 2. The upper trace indicates a low-frequency response of about 0. The trace should exhibit a sharp.5 mV/div). “Burn spots” should not be visible on the cathode-ray tube.24 Internal Discharge of Stored Energy. check the method of reset (i.. or disposable defibrillator electrodes are stored with the unit and are within their expiration dates. heart rate alarm. if so equipped). Inspection and Preventive Maintenance System ©1995 ECRI. 1. With the gain set to yield about 20 mm deflection for a 1 mV input (×2 or 0. pads.07 and 0. The calibration pulse or step response leading edge should have square corners (left). 1.Defibrillator/Monitors alarm-silence feature.. Excessive rounding or overshoot (right) indicates the need for adjustment. Operate the device to activate any audible signals (e.19 1 mV Step Response.21 Audible Signals.) Sixty-hertz or other noise (interference) should not be superimposed on the baseline with the ECG simulator attached. as well as the operation of a volume control. labels. Confirm that defibrillator gel is being used. If the device has an 1. Confirm appropriate volume. Check for adequate alarm tone volume and any associated features (e. but should be invisible throughout the lower two-thirds of the gain control range.05 Hz. The cathode-ray tube face will be discolored if this condition exists. see Figure 1). Depress and hold the 1 mV calibration button (or apply an external 1 mV pulse) for about 3 sec.. 1.09 Hz. Verify that defibrillator gel.e. Baseline interference may be apparent as a thick baseline at high gain settings. The lower trace indicates a low-frequency response of between 0.g.g. Figure 1. charge tone). the pulse should have decayed to no more than half its original amplitude (see Figure 2). Verify that the unit rapidly releases the stored energy when the power is turned off. 1. Slight rounding (middle) or small overshoot is acceptable.g. they should be within about 2 mm (10%) of each other. Notify appropriate clinical personnel if any accessories are missing. verify its operation. and instruction cards are present and legible. At a 20 mm deflection. Operate the device in such a way as to activate each audible and visual alarm (e. 1. or electrodes). 5 .20 Alarms. To protect personnel from accidental shock.. automatic direct writer activation. All Rights Reserved. manual or automatic) against the manufacturer’s specifications.23 Accessories (gel. display freeze function). it should be possible to discharge the stored energy safely in the event that the operator decides not to use the defibrillator after it has been charged. disposable defibrillator pads. (The phosphor may “burn” if the intensity is set too high. square-cornered leading edge that is neither rounded nor spiked (up to 10% spike or overshoot is acceptable but will usually not be observed in a unit that is functioning optimally.

or multimeter with good resolution of fractional ohms. When used with internal paddles for application of the defibrillator output directly to the heart. Verify that the alarm activates when the input rate is set just below or above typical low and high rate alarm settings (e. 119 to 126 bpm). in conjunction with Item 2. Synchronizer (major inspection only). electrical safety analyzer. Using an ohmmeter.25 Special Features. if applicable. Repeat this test for the charger. internal or pediatric paddles).. the unit should be able to deliver at least 250 J. charge the defibrillator to maximum energy. We recommend a maximum of 0. 6 Inspection and Preventive Maintenance System ©1995 ECRI.) This check should also be done for the reusable cable used with disposable defibrillation electrodes. Record the maximum leakage current. bend. Internal Paddle Energy Limit.6) and verify continuity with an ECG signal. whichever is greater. continuity checks.g. and charged. Perform the 1 mV step response test (Item 1. If the unit has a recorder. if additional paddles or disposable defibrillation electrodes are available for use with the defibrillator (e.Inspection and Preventive Maintenance System 1.15 Ω. and maximum energy settings. A continuity test will detect such a defect before it gets worse. The difference between the rate displayed on the rate indicator and that at which the alarm activates should not exceed 5% or 5 bpm. Quantitative tests 2. and pull the cable. confirm that it operates smoothly. Connect the internal paddles. or use an ohmmeter to verify continuity from each paddle or electrode connector to the appropriate pin of the connector. Internal paddles may require more frequent 2. At its maximum setting. Verify that the QRS visual and audible indicators are functioning.g.4 Rate Calibration. The resistance from the paddle or electrode connector to the appropriate pin of the connector should not exceed 0. a 50 J level is satisfactory for the intermediate range. Paddle continuity is typically checked by verifying the presence of an ECG signal obtained through the paddles (Item 1. to check that continuity is not affected. 2. Verify that the output does not exceed 50 J. . Paddle Continuity. and that the trace is of good quality (i. respectively). that the paper feeds evenly and does not stray from side to side. 40 and 120 bpm. 2.. verify that the heart rate indicator displays a rate within 5% or 5 bpm. (Current may jump across a small break in the paddle lead and may not be detected during defibrillator output tests. Using a simulated ECG with rates of 60 and 120 pulses per minute.3 2.5 Ω. If the unit has a synchronization mode. Wiggle. dark and thin) at all paper speeds. and delivered energy (measured by a defibrillator analyzer) after discharging the defibrillator into the analyzer as soon as it is charged. indicated energy (on the unit’s energy meter). verify that the unit will not discharge while in this mode when no ECG signal is present and that it will discharge when a simulated ECG is applied.19) on the recorder. of the set rate (55 to 65 bpm. If the output of a defibrillator is unusually low at very low control settings.5 2. these must be checked. All Rights Reserved. charging. Recorder.. The setup remains the same as for the previous test. measure and record the resistance between the grounding pin of the power cord (if so equipped) and exposed (unpainted and not anodized) metal on the defibrillator chassis. Either attach the paddles or electrode cable to the unit (e.9). The output energy should be within 4 J at low settings (below 25 J) or 15% of the set energy (and indicated energy if so equipped) at higher energies. and discharge it into the defibrillator analyzer. During major inspections.1 Grounding Resistance. At each energy level. intermediate.10 Output Energy.g. If the defibrillator is commonly used for cardioversion. Chassis Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened and the unit off. Test this feature on any unit that is located where it may be used with internal paddles or that may be moved to such a location. measure output energy at minimum.2 2. Rate Alarm. on. check for a break in the cables or a defective connector. However. record the control setting. whichever is greater. Chassis leakage current to ground should not exceed 300 µA. the energy should not exceed 50 J.6 2.e. especially near the paddle and connector..

stop the test and record the number of discharges and the values measured if the charging time exceeds 15 sec before the 10th discharge.1 3. even after charging for 12 hr or more. Set the defibrillator to deliver low output energy (50 J or less).e. Use an ECG signal to trigger Inspection and Preventive Maintenance System ©1995 ECRI. 4. Check the synchronizers of units so equipped. and interlead) to defibrillator paddles. 7 . sink. CAUTION: Do not perform this test on all battery-operated defibrillators in an area on the 3. The time to charge to maximum energy should not exceed 15 sec. Replace the battery if any of the test procedures indicate it is weak or defective. Lubricate the chart recorder paper drive per the manufacturer’s recommendations. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. if so equipped. In this case. Deterioration of the energy storage capacitors in some defibrillators results in charge leakage after the charging circuit has been de-energized. on some defibrillators. (Note that some units are designed to intentionally bleed or discharge the capacitor charge if the defibrillator is not discharged within a set time period. Charge the defibrillator to its maximum setting. Interlead testing should include both ECG-to-ECG and ECG-paddle tests.10) and should meet manufacturer specifications for charge leakage.. interlead.12 Charge Time and Max Energy (10th Charge). Be sure that all batteries are checked. In addition. rollers. The following test will identify this deficiency. All Rights Reserved. Also stop the test if the battery-condition meter indicates a weak battery or. Use the defibrillator’s internal test load. record the charging time (i. The output energy should remain within 4 J or 15% of the selected energy throughout the test. To avoid excessive battery depletion. mark the date of the battery replacement on the battery or unit and check it during each inspection. if the internal circuitry terminates the charge early.4 same day unless provisions are made for backup units or spare charged batteries. 2.Defibrillator/Monitors During minor inspections. AAMI DF-2-1989. These deficiencies are best discovered during periodic inspections. Preventive maintenance Clean the exterior. but with limits of 100 µA for external paddles and 50 µA for internal paddles.1 Synchronizer Operation. In resuscitation attempts. rather than during clinical use. increases reliability and decreases service calls. 4. Some units have more than one battery (e. Some users have also reported that periodic prophylactic battery replacement. The delivered energy should be at least 85% of that obtained when the unit is discharged immediately (as in Item 2. and a fully charged unit must be available for emergencies. if required. Standard for Cardiac Defibrillator Devices. On the 10th cycle. Batteries may take considerable time to recharge. calls for applying isolated input risk current tests (source. and input isolation tests. Battery-powered defibrillators may not have sufficient energy left in their batteries to deliver 10 shocks. perform the following tests. and replaced as required. 3.2 3. Charge battery-powered units to maximum energy and discharge 10 times through the analyzer (verify that the analyzer load will not be damaged by repeated discharge).11 Energy After 60 Sec. one for the monitor and one for the defibrillator. CAUTION: Do not measure paddle leakage current with the unit charged or charging or during discharge. but do not discharge for 1 min. paddles. Perform the inspection after battery replacement and a suitable charge period. and platen. it is not uncommon for the operator to call for multiple defibrillation shocks in rapid succession. maintained. Typically. the time for the meter to equilibrate or for the ready light to come on) and the delivered energy. this provides either a numeric or a pass/fail indicator to verify that energy was delivered. These units should meet manufacturer specifications.g. either annually or every other year.) 2. it is possible for the available energy to decrease if the unit is not discharged at the earliest possible moment. verify output at only one energy level. The thoroughness of this test will depend upon the availability of test equipment. Most ECG monitors should meet the requirements for isolated input devices for ECG lead-to-ground.. In these units. batteries that can be switched by the user).

Inspection and Preventive Maintenance System
the synchronizer and fire the defibrillator into a 50 Ω load (e.g., a defibrillator analyzer). Confirm that, with the ECG simulator off, the defibrillator does not discharge. With a signal applied, confirm that the synchronizer marker or other indicator is functioning properly. Use a dual-channel oscilloscope to note the time delay between the peak of a QRS pulse (from an ECG simulator) and the defibrillator pulse (from a defibrillator analyzer). Use the ECG signal to trigger the oscilloscope’s sweep. Some defibrillator analyzers have synchronizer test functions. With an ECG amplitude sufficient to activate the marker or indicator and the discharge buttons depressed, the defibrillator should discharge in 60 msec or less following the R-wave peak. Most units will trigger on the first QRS pulse after the buttons are depressed, although some units are designed to delay until the second or third QRS to avoid unintentional discharges. 4.2 Internal Paddle Energy Limit. During acceptance testing, perform Item 2.6 on all units equipped with this feature, regardless of intended location for the device. Integral Output Tester. Check the operation and accuracy of any integral defibrillator test load, if so equipped. Common Mode Rejection Ratio (CMRR). The ECG monitor includes a differential amplifier so that it can display the voltage difference between two electrodes (the RA and LA in Lead 1) while using a third (RL) as a reference. If the same, or common, voltage is applied to RA and LA simultaneously, there should be no output from the differential amplifier because the voltage difference between the two inputs is zero. The extent to which a differential amplifier produces no output when the same signal is applied to both inputs is called its common mode rejection ratio. Common mode rejection is needed in monitors because of the presence of stray signals, common to all input leads primarily at power-line frequency (60 Hz). While these signals are too minute to be hazardous, they can interfere with the ECG display of a monitor with a low CMRR at 60 Hz. The CMRR is defined as:
CMMR = Differential mode deflection factor, or DMD (mm ⁄ mV) Common mode deflection factor, or CMD (mm ⁄ mV)

Figure 3. Signal input test setup. input signal (in mV). The CMRR may then be calculated as the differential mode deflection factor divided by the common mode deflection factor. A deflection factor is the change in trace position corresponding to a given input voltage to the monitor. Use an unbalanced CMRR measurement that has a 5,000 Ω resistor in series with one of the input leads to the monitor. This simulates unequal impedances in the electrode/skin interface of the monitor electrodes, as commonly exists in practice. Since most common mode voltage in the hospital is at 60 Hz, it is most significant to measure the CMRR at or near that frequency. (A frequency of 55 Hz is often used to minimize interference from power-line frequency noise.) Using the test setup shown in Figure 3, apply a sinusoid test signal of 1 mV peak-to-peak at about 60 Hz to the monitor. Turn up the monitor gain so that the deflection is at least 20 mm. Measure the deflection in millimeters, and record it on the inspection form as the differential mode deflection factor. Since the input signal for this measurement was 1 mV, the differential mode deflection factor expressed in mm/mV is numerically equal to the resultant deflection in millimeters. Do not vary the gain of the monitor or the signal frequency for the remainder of this test. Record the frequency on the form. Use the test setup shown in Figure 4 for the second part of this measurement. Note that there is only one connection from the output of the attenuator to the patient leads. The other output terminal is grounded. It is essential that all instruments used in this test be connected to a common ground to minimize noise.

4.3

4.4

Calculate the common mode deflection factor by dividing the resultant deflection (in mm) by the

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Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

Defibrillator/Monitors
correction should be made in calculating paper speed. The paper speed should be accurate to within 2% (although 5% is allowed by some organizations). At a chart speed of 25 mm/sec and a pulse interval of 1,000 msec (60 bpm on an ECG simulator), the distance between the first and last of 5 successive peaks should be 100 ±2 mm; at a chart speed of 50 mm/sec, the distance between the first and last of 5 successive peaks should be 200 ±4 mm. 4.8 Figure 4. Common mode rejection ratio test setup. Increase the amplitude of the sinusoid signal (up to 10 V peak-to-peak) until some measurable deflection is observed on the monitor. If the unit has an ungrounded or plastic case, measure the CMRR with the unit resting on a grounded metal plate. CMRR should meet the manufacturer’s specification and be at least 10,000:1. 4.5 Gain. Apply a 2 mV signal at a gain setting of 10 mV/mm (or ×1) and measure the displayed amplitude with a transparent scale. Verify that the displayed signal size changes appropriately (within 10%) as the gain setting is changed. For example, if a 2 mV signal produces a 20 mm deflection at a ×1 gain, the deflection should be 36 to 44 mm at ×2. Test both the monitor display and recorder. QRS Sensitivity. If the monitor includes a QRS indicator or beeper or a heart rate meter, verify that the QRS detector circuit is functioning properly. Connect an ECG simulator with variable output to the monitor, and set it for a rate of 60 bpm. Vary the output amplitude over a range of 0.5 to 5 mV (use the monitor, display to estimate amplitude if the simulator does not have a calibrated output). The monitor should reliably detect all beats and should not doublecount. It should not detect QRS amplitudes of less than 0.15 mV. If the unit has a manual sensitivity control, check that it is functioning properly as evidenced by the need to change the setting during this test. Paper Speed. On units with a chart recorder, use an ECG simulator set to 60 bpm or a signal or pulse generator set to 1 Hz that has been set or calibrated with a counter. If the interval between pulses is not within 10 msec of 1,000 msec, an appropriate Alarm Delay. In addition to checking rate alarm accuracy (Item 2.5), use the same test setup to determine alarm delay. First, set the high rate alarm to 100 bpm and the ECG simulator to 60 bpm. Quickly change the simulator rate to 120 bpm, and use a stopwatch or watch with a second hand to measure the time until the alarm sounds. Check the low rate alarm similarly (set alarm for 40 bpm, change rate from 60 to 30 bpm). Generally, alarm delays should not exceed about 10 sec. Repeated Discharge and Operating Time.Verify that the battery meets hospital or manufacturer specifications for number of defibrillation shocks and monitor operating time. Units should meet requirements with all functions operating (including alarms sounding) unless otherwise specified. Perform Item 2.12 on line-powered units to verify that each unit is able to provide at least 10 sequential defibrillation shocks.

4.9

4.6

Before returning to use
Return the energy select control to its normal setting. Before connecting the charger on battery-powered units, check the battery condition to verify that there is adequate battery charge. If there is not, or if doubt exists, ensure that a suitable replacement defibrillator is available, and allow the unit just inspected to charge in an out-of-the-way location (i.e., where it will not be taken for use by clinical personnel). Battery-powered units should be connected to the charger, with the charger plugged into a wall outlet and the charging light on. For units with removable batteries that are charged in a separate charger, replace the battery used during testing with a fully charged battery, and place the used battery in the charger for proper charging. Conduct a performance verification check, including pressing all the front-panel function buttons, to verify that the unit is in a standard service mode. Performance-verification procedures are often included in the service manual.

4.7

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

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Procedure/Checklist 407-0595

Defibrillators
Used For:
Defibrillators, Battery-Powered [11-134] Defibrillators, Line-Powered [11-137]

Also Called: Cardioverters Commonly Used In: Coronary and special care areas, emergency departments, operating rooms, resuscitation carts, patient care areas, emergency medical vehicles Scope: Applies to battery- and line-powered defibrillators used with external and internal paddles and/or disposable defibrillation electrodes; does not apply to units that have both defibrillation and monitoring functions (see Defibrillator/Monitors Procedure/Checklist 408) Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . . hours hours

Overview
Defibrillators are critical resuscitation instruments. Their failure to perform effectively may result in the death of a patient undergoing resuscitation or cause further cardiac damage or even death in a patient undergoing elective cardioversion or emergency cardioversion of a life-threatening arrhythmia. Failure to successfully defibrillate a patient may occur for a number of reasons, including inadequate predefibrillation cardiopulmonary resuscitation (CPR) technique, operator error (e.g., poor paddle application), or depleted or defective batteries (the most common cause of defibrillator failure with battery-powered units). There is no time to troubleshoot or correct even minor difficulties during emergencies, since every minute of delay significantly decreases the probability of a successful resuscitation attempt. In addition to periodic inspection, clinical staff should perform inspections and ensure that batterypowered units are charging at the beginning of each work shift and after each use of the device. They should

also perform discharge testing at least once a week. A User Checklist for Defibrillator/Monitor/Pacemakers is included in Health Devices 1993 May-Jun; 22:291-2.

Citations from Health Devices
Daily checks of defibrillators [Consultant’s Corner], 1983 Mar; 12:120-1. Line-powered defibrillators [Evaluation], 1983 Oct; 12:291-314. Defibrillating patients connected to electrocardiographs [Evaluation], 1984 Aug; 13:254. User error and defibrillator discharge failures [Hazard], 1986 Dec; 15:340. Deteriorating insulation on internal defibrillator paddles [Hazard], 1987 Feb; 16:46. Defibrillator paddle resistance (continuity) testing [User Experience NetworkTM], 1987 Feb; 16:55. Disposable defibrillator pads and electrodes [Evaluation], 1990 Feb; 19:33-56.

009021 407-0595
A NONPROFIT AGENCY

5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275

q

E-mail info@ecri.org

Inspection and Preventive Maintenance System
Hewlett-Packard defibrillator/monitors and Darox R2 electrodes [User Experience NetworkTM], 1990 Jul; 19:246. ECG artifact and defibrillator/monitors [User Experience NetworkTM], 1991 Mar-Apr; 20:141. Internal defibrillator paddles [User Experience NetworkTM], 1991 Dec; 20:497-8. Use of Physio-Control Lifepak 8 defibrillator/monitors with optional QUIK-PACE pacing cassette [User Experience NetworkTM], 1992 May; 21:183. Overheating of replacement batteries in Physio-Control Lifepak 6, 6s, and 7 defibrillator/monitors [Hazard Update], 1992 Jun-Jul; 21:250. Defibrillator/monitors and external noninvasive pacemakers [Evaluation], 1993 May-Jun; 22:212-94. Defibrillator/monitors and external noninvasive pacemakers [Evaluation Update], 1993 Dec; 22:579-82. Misalignment of mating cable and defib cassette connectors on Physio-Control Lifepak 8 defibrillator/monitor [Hazard], 1993 Dec; 22:595-7. Fires from defibrillation during oxygen administration [Hazard], 1994 Jul; 23:307-9. Spontaneous charging of Hewlett-Packard 43100A defibrillator/monitor used with anterior/posterior paddle set during monopolar electrosurgery [Hazard], 1994 Oct-Nov; 23:455-6. you have confirmed that the defibrillator is disarmed (not charged) and preferably off. Testing input isolation requires the use of a line voltage source. Although this source should include a current-limiting resistor, use caution to avoid contact with any portions of the circuit while it is energized. A defibrillator must be available in the event that an emergency occurs during the inspection. Thus, perform the inspection in the vicinity of the unit’s usual storage location, or ensure that a similar unit that the clinical staff is familiar with is available as a substitute. Battery depletion may occur as a result of the inspection testing of battery-powered units. Ensure that a replacement unit or a fully charged battery is available before you begin testing. Do not test all batterypowered units in an area at the same time, since this will leave the staff inadequately equipped to handle emergencies until the batteries recharge.

Procedure
Before beginning an inspection, carefully read this procedure and the manufacturer’s instruction and service manuals; be sure that you understand how to operate the equipment and the significance of each control and indicator. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Defibrillator energies may be specified in either joules (J) or watt-seconds; these are equivalent units (i.e., 1 J = 1 watt-second).

Test apparatus and supplies
Defibrillator analyzer Ground resistance ohmmeter Leakage current meter or electrical safety analyzer Stopwatch or watch with a second hand ECG simulator and ECG monitor (only for units with synchronization capability) Oscilloscope (acceptance testing only) Isolation test supply (included in some electrical safety analyzers; acceptance testing only)

1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment. Casters/Brakes. Check the condition of cart casters. Look for accumulations of lint and thread around the casters, and be sure that they turn and swivel, as appropriate. Check the operation of brakes and swivel locks, if the cart is so equipped.

1.2

Special precautions
CAUTION: The high voltage present on defibrillator paddles during discharge is extremely dangerous and possibly lethal. Never perform testing alone. A second person must be present to summon help and/or apply CPR in the event of an emergency. Never hold or contact the conductive electrode portion of the paddles unless 1.3

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Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

Defibrillators
1.4 AC Plug. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. If the device is mounted on a cart that has electrical receptacles for additional equipment, insert an AC plug into each and check that it is held firmly. Inspect resuscitation cart receptacles, including testing for wiring (e.g., using an outlet tester) and tension of all three connections. Also inspect the resuscitation cart plug for damage as described above. 1.5 Line Cord. Inspect the cord (including resuscitation cart line cord, if appropriate) for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the correct polarity. Check line cords of battery chargers. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the device has a switchtype circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare is provided. Cables. Inspect the cables of internal and external paddles, disposable defibrillation electrodes (if applicable), and synchronizer cables for their strain reliefs and general condition. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors at each end to prevent rotation or other strain. cleanliness. Alert clinical personnel responsible for the instrument to the presence of dried electrode gel, physiologic fluids, or debris on the paddle surface or handles. Dirty electrodes prevent good electrical contact and often cause burns. Electrode gel or other debris on the insulating portion of the paddle can cause operator shocks. Clean the paddles if needed, including electrode surfaces and handle seams, and ensure that they are completely dry before proceeding with any testing. Confirm that an adequate supply of ECG electrodes and disposable defibrillation electrodes (if used) are available and that they are stored properly and are within their expiration dates. 1.13 Controls/Switches. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, check that each control and switch performs its proper function. If the unit has redundant control functions (e.g., a charge button on the front panel and on a paddle), ensure that both controls function properly. Verify that activating just one paddle discharge button will not discharge the unit (both buttons must be pressed simultaneously to discharge). A front-panel discharge button should control only internal paddles (or disposable defibrillator electrodes on some units) and should not cause discharge when external paddles are connected. 1.17 Battery/Charger. Inspect the physical condition of batteries and battery connectors, if readily accessible. Verify that the charger of battery-operated units is plugged into a live AC outlet and that the charger is attached to the defibrillator (i.e, charger cable is attached, unit is firmly seated into charging stand or mount, instrument end of line cord is attached, and charging light is on). For units with removable batteries that are charged in a separate charger, verify that the batteries are properly installed and that the charging, or ready, light is on. Inform clinical personnel of any deficiencies or improper use. Perform the inspection with the unit on battery power to check that the defibrillator batteries are

1.6

1.7

1.9

1.10 Fittings/Connectors. Examine all cable connectors for general condition. Electrical contact pins or surfaces should be straight and clean. Verify that leads and electrodes are firmly gripped in their appropriate connectors. During major inspections, disconnect the paddle connectors and look for misaligned pins, damaged receptacles, and carbon deposits from arcing. 1.11 Paddles/Electrodes. Confirm that special paddles (e.g., pediatric, internal) and electrodes (e.g., disposable defibrillation electrodes) are available if appropriate for the area of use. Examine all paddles for physical condition and

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

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Inspection and Preventive Maintenance System
charged and can hold a charge. Check battery capacity by activating the battery test function or measuring the battery-powered operating time. When it is necessary to replace a battery, label it with the date. Some batteries require periodic deep discharges and recharging to maintain maximum capacity. If the manufacturer recommends this procedure, verify that it is being performed on schedule. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, meters, gauges, and visual displays on the unit and charger, if so equipped. Be sure that all segments of a digital display function. 1.21 Audible Signals. Operate the device to activate any audible signals (e.g., charge tone). Confirm appropriate volume, as well as the operation of a volume control. 1.22 Labeling. Check that all necessary placards, labels, and instruction cards are present and legible. 1.23 Accessories (gel, pads, or electrodes). Verify that defibrillator gel, disposable defibrillator pads, or disposable defibrillator electrodes are stored with the unit and that they are within their expiration dates. Confirm that defibrillator gel is being used, not skin lubricant or ultrasound or TENS gel. Notify appropriate clinical personnel if any accessories are missing. 1.24 Internal Discharge of Stored Energy. To protect personnel from accidental shock, it should be possible to discharge the stored energy safely in the event that the operator decides not to use the defibrillator after it has been charged. Verify that the unit releases the stored energy when the power is turned off. If the unit has a front-panel button for this purpose, verify proper operation. 1.25 Synchronizer. If the unit has a synchronization mode, verify that the unit will not discharge while in this mode when no ECG signal is present and that it will discharge when a simulated ECG signal is applied. 2.3 exposed (unpainted and not anodized) metal on the defibrillator chassis (and charger if applicable). We recommend a maximum of 0.5 Ω. 2.2 Chassis Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened and the unit off, on, charging, and charged. Record the maximum leakage current. Leakage current from chassis to ground should not exceed 300 µA. Paddle Continuity. Use an ohmmeter to verify continuity from each paddle (internal and external) to the appropriate pin of the paddle connector. Wiggle, bend, and pull the cable, especially near the paddle and connector, to check that continuity is not affected. (Current may jump across a small break in the paddle lead and may not be detected during defibrillator output tests. An ohmmeter test will detect such a discontinuity before it gets worse.) This check should also be done for the reusable cable used with disposable defibrillation electrodes. Internal paddles may require more frequent continuity checks. The resistance from the paddle to the appropriate pin of the paddle connector should not exceed 0.15 Ω. Energy After 60 Sec. Deterioration of the energy storage capacitors in some defibrillators results in charge leakage after the charging circuit had been deenergized. In these units, it is possible for the available energy to decrease if the unit is not discharged at the earliest possible moment. Use the following test to identify this deficiency. Charge the defibrillator to its maximum setting, but do not discharge it for 1 min. The delivered energy should be at least 85% of that obtained when the unit is discharged immediately (as in Item 2.10) and should meet manufacturer specifications for charge leakage. (Some units are designed to intentionally bleed or discharge the capacitor charge if the defibrillator is not discharged within a set time period. These units should meet the manufacturer’s specifications.) 2.5 Internal Paddle Energy Limit. Defibrillator output, when used with internal paddles, should not exceed 50 J. Test this feature on any unit that is located where it may be used with internal paddles or that is portable and may be moved to such a location. Connect the internal paddles, charge the unit to maximum energy, and discharge it

2.4

2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord (or charger power cord) and

4

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

Defibrillators
into the defibrillator analyzer. Verify that the output does not exceed 50 J. 2.10 Output Energy. During major inspections, measure output energy at minimum, intermediate, and maximum energy settings. If the defibrillator is commonly used for cardioversion, a 50 J level would be satisfactory for the intermediate range. At each energy level, record the control setting, indicated energy (on the unit’s energy meter), and delivered energy (measured by an analyzer) after discharging the defibrillator into the analyzer as soon as it is charged. At its maximum setting, the unit should be able to deliver at least 250 J. The output energy should be within 4 J at low settings (below 25 J) or 15% of the set energy (and the indicated energy, if so equipped) at higher energies. If the output is unusally low at very low control settings, check for a break in the cables or a defective connector. During minor inspections, verify output at only one energy level. Use the defibrillator’s internal test load, if so equipped. Typically, this provides a numeric or a pass/fail indicator to verify that energy was delivered. 2.11 Charge Time and Max Energy (10th Charge). In resuscitation attempts, it is not uncommon for the operator to call for multiple defibrillation shocks in rapid succession. Battery-powered defibrillators may not have sufficient energy left in their batteries to deliver 10 shocks. These deficiencies are best discovered during periodic inspections, rather than during clinical use. Charge battery-powered units to maximum energy and discharge 10 times through the analyzer (but first verify that the analyzer load will not be damaged by repeated discharge). On the 10th cycle, record the charging time (i.e., the time it takes the meter to equilibrate or the ready light to come on) and the delivered energy. To avoid excessive battery depletion, stop the test and record the number of discharges and the values measured if the charging time exceeds 15 sec before the 10th discharge. Also stop the test if the battery-condition meter indicates a weak battery or, on some defibrillators, if the internal circuitry terminates the charge early. The time to charge to maximum energy should not exceed 15 sec. The output energy should remain within 4 J or 15% of the selected energy throughout the test. CAUTION: Do not perform this test on all battery-operated defibrillators in an area on the same day unless provisions are made for backup units or spare charged batteries. Batteries may take considerable time to recharge, and a fully charged unit must be available for emergencies.

3. Preventive maintenance
3.1 3.4 Clean the exterior and paddles. Replace the battery if any of the test procedures indicate a weak or defective battery, even after charging for 12 hr or more. Some users have also reported that periodic prophylactic battery replacement, either annually or every other year, increases reliability and decreases service calls. In such a case, mark the date of the battery replacement on the battery or unit and check it during each inspection. Perform the inspection after battery replacement and a suitable charge period. Since some units have more than one battery, be sure that all batteries are checked, maintained, and replaced as required.

4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. CAUTION: Do not measure paddle leakage current with the unit charged or charging or during discharge. AAMI DF-2-1989, Standard for Cardiac Defibrillator Devices, calls for applying isolated input risk current tests (source, sink, and interlead) to defibrillator paddles, but with limits of 100 µA for external paddles and 50 µA for internal paddles. In addition, perform the following tests. 4.1 Synchronizer Operation. Check the synchronizers of units so equipped. An independent monitor must be used in conjunction with the defibrillator to allow synchronized operation (although this can be done, AAMI does not recommend it). The thoroughness of this test will depend upon the availability of test equipment. Connect the monitor that will be used clinically to the defibrillator. Supply an ECG signal from an ECG

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

5

11 on line-powered units to verify that the unit is able to provide at least 10 sequential defibrillation discharges. after the discharge buttons are depressed. check the battery condition to verify that there is an adequate battery charge. or if doubt exists. Integral Output Tester. a defibrillator analyzer). The delay time between the application of the most recent synchronizing signal from the monitor and the discharge should not exceed 25 msec. ensure that a suitable replacement defibrillator is available. Most units will trigger on the first QRS after depressing buttons. the defibrillator does not discharge. If there is not. . Thus.. Confirm that. where it will not be taken for use by clinical personnel). replace the battery used during testing with a fully charged battery and place the used battery in the charger for proper charging. Set the defibrillator to deliver low output energy (50 J or less). Check the operation and accuracy of any integral defibrillator test load. the overall delay from the defibrillator and monitor should not exceed 60 msec. Repeated Discharge. Otherwise. Use a dual-channel oscilloscope to note the time delay between the peak of a QRS pulse (from an ECG simulator) and the defibrillator pulse (from a defibrillator analyzer).5 on all units equipped with this feature.. Verify that the battery meets hospital or manufacturer specifications for the number of defibrillator shocks that can be delivered. with the ECG simulator off.e. For units with removable batteries that are charged in a separate charger. connect battery-powered units to the charger. With an ECG amplitude sufficient to activate the marker or indicator.2 Internal Paddle Energy Limit. Some defibrillator analyzers have synchronizer test functions.4 Before returning to use Return the energy-select control to its normal setting.3 4.Inspection and Preventive Maintenance System simulator to the monitor to trigger the discharge of the defibrillator into a 50 Ω load (e. and verify that the charging light is on. 4. if so equipped. confirm that the synchronizer marker or other indicator is functioning properly. plug the charger into a wall outlet. 6 Inspection and Preventive Maintenance System ©1995 ECRI. although some units are designed to delay until the second or third QRS to avoid unintentional discharges.g. During acceptance testing. All Rights Reserved. regardless of the location intended for the device. Before connecting the charger on battery-powered units. Perform Item 2. 4. perform Item 2. With a signal applied. the defibrillator should discharge within 60 msec or less following the peak of the R wave. and allow the unit just inspected to charge in an out-of-the-way location (i. Use the ECG signal to trigger the oscilloscope’s sweep. The monitor should provide its synchronizing signal within 35 msec of the R wave peak.

Since the monitor is used only to observe the patient’s basic cardiac rhythm. cardiac catheterization laboratories Scope: Primarily applies to stand-alone ECG monitors (line or battery powered). 22:301. critical care units as part of a physiologic monitoring system. . does not apply to ECG arrhythmia monitors or to monitors in defibrillator/monitor units (use Defibrillator/Monitors Procedure/Checklist 408) Risk Level: ECRI Recommended. Overview ECG monitors are routinely used on patients with known or suspected cardiac arrhythmias. appropriate for use in conjunction with other procedures when inspecting physiologic monitoring systems that include multiple physiologic parameters. 21:123-8. hours hours This procedure is generally not required for a permanently installed system if the hospital routinely performs a visual inspection of the area. it need not meet the accuracy and fidelity criteria expected of an electrocardiograph. 1985 MarApr. 1982 Nov. paying reasonable attention to the monitors. 1991 MarApr. 1991 Mar-Apr. 20:140. also applies to rate meters and direct writers for monitors with these features. The monitors display the patient’s electrocardiogram so that those attending the patient may continuously observe the electrical activity of the heart.org . 1991 Sep. emergency rooms. 1985 Mar-Apr. 20:362. Physiologic patient monitors [Evaluation update]. 1992 Mar-Apr.Procedure/Checklist 409-0595 ECG Monitors Used For: ECG Monitors [12-599] Also Called: Cardiac monitors Commonly Used In: Operating rooms. PA 19462-1298. ECG artifact in the OR [User Experience NetworkTM]. Citations from Health Devices Artifacts from piezoelectric voltages [Consultant’s Corner]. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. Thermal injuries and patient monitoring during MRI studies [Hazard]. 1993 May-Jun. Hospital Assessment. GIGO: A compendium of ECG monitoring problems. 14:158. Test apparatus and supplies ECG simulator (calibrated output amplitudes and rates may be required for some tests) Leakage current meter or electrical safety analyzer 009026 409-0595 A NONPROFIT AGENCY 5200 Butler Pike. 14:143. 20:81. other special care areas. Patient monitoring systems [Evaluation]. High. adaptable for use with ECG telemetry systems and systems with central stations. 12:27. Risk of electric shock from patient monitoring cables and electrode lead wires [Hazard]. Plymouth Meeting. Type Major Minor * ECRI-Recommended Interval 12 months* NA Interval Used By Hospital months months Time Required . Physiologic patient monitors [Evaluation].

Also check line cords of battery chargers. body temperature unit. Inspect the cord for signs of damage.. Examine the exterior of the unit for cleanliness and general physical condition. blood pressure unit. Ensure that a replacement unit or a fully charged battery is available before you begin testing. Qualitative tests 1. using LA and RA as inputs). recorder). Enter all module control numbers in the System Components box on the form.g. Examine the AC power plug for damage. On singlechannel units that have lead switching. When a monitor is part of a system with a remote or central station display.4 1. AC Plug. since this will leave the staff inadequately equipped.3 1. if the unit is so equipped. assign a separate control number to the mainframe and to each discrete module. All Rights Reserved. If the device is configured (i. . except where otherwise indicated. list any functions that will be inspected but recorded on separate inspection forms (e. This will help you locate the whole monitor or an individual module if follow-up action is needed. If it is attached to a wall or rests on a shelf. and note the use of other forms. In the System Components box. use caution to avoid contact with any portions of the energized circuit.g. different functions are not in removable modules but are contained within a single integral housing). the significance of each control and indicator. central station alarm sounds.. be sure that you understand how to operate the equipment. and indicate which are covered on separate forms. all tests can be performed in one lead. Be sure that plastic housings are intact.g. use a separate inspection form to record results for each display. assign only one control number. Look for accumulations of lint and thread around the casters.. Line Cord. 1. Be sure to wire a new power cord or plug with the same polarity as the old one. and that there are no signs of spilled liquids or other serious abuse. blood pressure). 1..g.e. that all assembly hardware is present and tight. Enter cross-referenced data related to the ECG monitor at the top of the inspection form. quality of central chart recorder tracing) from only one bedside. check the security of this attachment. Conductive Furniture and Floors). if the damage is near one end. Do not test all the units in an area at one time. Conductivity checks. cut out the defective portion. Attempt to wiggle the blades to determine that they are secure. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Although this source should include a current-limiting resistor. Mount.g. chart recorder activates when heart rate exceeds set limits). This is most easily accomplished with two people.Inspection and Preventive Maintenance System Ground resistance ohmmeter The following equipment is necessary during acceptance testing only: Signal generator Attenuator Oscilloscope Transparent metric scale Stopwatch or watch with a second hand Some monitors or monitoring systems provide multilead ECG signal processing and display (simultaneous display of two ECG leads). Test displays for each bedside separately. Special precautions Testing monitor isolation requires the use of a line voltage source. check their condition. as appropriate.5 2 Inspection and Preventive Maintenance System ©1995 ECRI. If damaged. Conduct display quality and performance tests on each channel. and be sure that they turn and swivel. Casters/Brakes. Since the monitor may be installed in a mainframe along with other removable modules (e. using the appropriate electrode leads (e. examine the condition of the mount. replace the entire cord or. Procedure Before beginning an inspection. Inspection testing may deplete the battery of battery-powered units. Enter the mainframe control number in the Control No. where appropriate. Verify interactive functions from each bedside (e.1 Chassis/Housing. lead I.. If the device moves on casters. If any damage is suspected. carefully read this procedure and the manufacturer’s instruction and service manuals. Shake the plug and listen for rattles that could indicate loose screws.. space of the inspection form to identify the entire device.2 1. open the plug and inspect it. and the alarm capabilities. but test common elements (e. are usually done more efficiently as part of a check of all equipment and furniture of an area (see Procedure/Form 441. Check the operation of brakes and swivel locks. If the device is mounted on a stand or cart.

and check the electrodes’ physical condition. Perform the inspection with the unit on battery power or operate the unit on battery power for several minutes to check that the batteries are charged and can hold a charge. indicators. Where a control should operate against fixed-limit stops.. a gain control at maximum. Check battery capacity by activating the battery test function or measuring the output voltage. if readily accessible. verify that it is being performed on schedule.. Check that control knobs have not slipped on their shafts. If any of them appear inordinate (e.g. Circuit Breaker/Fuse. making the ECG difficult to see. 1.9 1. pens). and correct motion. including the Pwave and QRS. Flex the patient cable near each end to verify that there are no intermittent faults. In monitors that incorporate a self-centering baseline (and thus lack a position control). Cables. The pulses from an ECG simulator should be regularly spaced (uneven spacing indicates a sweep nonlinearity). 1. check their positions. Record the settings of those controls that should be returned to their original positions following the inspection.g. If the device is protected by an external fuse.10 Fittings/Connectors. Inspect the patient cable and leads and their strain reliefs for general condition. consider the possibility of inappropriate clinical use or of incipient device failure. Inspect the physical condition of batteries and battery connectors. in fact. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors of each end to prevent rotation or other strain. Connect the unit to an ECG simulator and verify that an adequate trace is received at each patient lead selection. 1.ECG Monitors 1. During the course of the inspection. and visual displays on the unit and the charger (if appropriate). check that each control and switch performs its proper function. Be sure that they hold the cord securely. When the vertical position of the baseline is varied by adjusting the vertical position control. confirm that it does. When it is necessary to replace a battery. During the course of the inspection. the baseline should move throughout most of the vertical height of the display. Before moving any controls and alarm limits. (If monitors are located so that ambient light reflects from the face of the display. There should be no distortion in the baseline as it is moved up or down on the screen. Examine the strain reliefs at both ends of the line cord. Verify that leads and electrodes are firmly gripped in their appropriate connectors. Check operation of battery-operated power-loss alarms. and verify compliance with the following criteria: The baseline should stay in focus across the display. Check the condition of the battery charger and. label it with the date.18 Indicators/Displays. Some batteries require periodic deep discharges and recharging to maintain maximum battery capacity. Verify that functions are activated when the center of the desired function box is touched. check its value and type against that marked on the chassis. Observe a simulated ECG signal on a CRT display. the baseline should be correctly positioned. 1. to the extent possible. Inspection and Preventive Maintenance System ©1995 ECRI. Ambient light should not affect the visibility of the trace. Check alignment of touchscreen sensors. and ensure that a spare is provided. if so equipped. The baseline should be horizontal and should not be noticeably sloped or bowed. Check membrane switches for membrane damage (e. If the device has a switch-type circuit breaker. All portions of a simulated ECG waveform should be clear and visible.13 Controls/Switches. All Rights Reserved.7 1. meters. charge the battery. Be sure that all segments of a digital display function. alarm limits at the ends of their range). Examine all controls and switches for physical condition. Confirm that an adequate supply of electrodes is on hand. check for proper alignment. as well as positive stopping.11 Electrodes. Examine all cable connectors for general condition. 3 . check that it moves freely. confirm the operation of all lights.6 Strain Reliefs. secure mounting. con- 1. Electrical contact pins or surfaces should be straight and clean. If this is recommended by the manufacturer.17 Battery/Charger. from fingernails.

the cathode-ray tube face will be discolored if this condition exists. measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the defibrillator chassis (and charger chassis if appropriate). they should be within 2 mm (±10%) of each other. 2. that the paper feeds evenly and does not stray from side to side.19) on the direct writer. 1.19 1 mV Step Response.) “Burn spots” should not be visible on the cathode ray tube.21 Audible Signals. If the unit has a direct writer. compare the amplitude of the internal calibration pulse and an external 1 mV signal (from a calibrated ECG simulator). verify grounding of the mainframe and each module.e.Inspection and Preventive Maintenance System trol the light or use a filter over the display faceplate.5 Ω. Chassis Leakage Current. Operate the device in such a way as to activate each audible and visual alarm. 1. All Rights Reserved. Check for adequate alarm tone volume and any associated features. of the set rate (55 to 65 bpm. including on. or multimeter with good resolution of fractional ohms.22 Labeling. 2. Verify that the QRS visual and audible indicators are functioning. verify that the heart rate indicator displays a rate within 5% or 5 bpm.10 Rate Calibration. and off. (If the intensity is set too high. whichever is greater. check that the unit resets automatically or that the manual reset functions. Confirm appropriate volume. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. the pulse should have decayed no more than half its original amplitude (see Figure 1). Operate the device in all normal modes. Verifying low grounding resistance is adequate. and instruction cards are present and legible..2 step response test (Item 1. and that the trace is of good quality (i. 1. Slight rounding (middle) or small overshoot is acceptable. confirm that it operates smoothly. such as automatic direct writer activation or display freeze function. Excessive rounding or overshoot (right) indicates the need for adjustment. Baseline interference may be apparent as a thick baseline at high gain settings but should not be visible throughout the lower two-thirds of the gain control range. the phosphor may “burn”. After 1 sec. If a bedside or central station monitor is grounded through system interconnections in addition to power-line grounding (and is used only in this configuration). Using an ohmmeter. do not disconnect the monitor from the system to measure chassis leakage current during routine inspections. We recommend a maximum of 0. The trace should exhibit a sharp square-cornered leading edge that is neither rounded nor spiked (any spike should be less than 10%). Operate the device to activate any audible signals. Check that all necessary placards. The calibration pulse or step response leading edge should have square corners (left). With the gain set to yield about 20 mm deflection for a 1 mV input (×2 or 1/2 mV/div). Quantitative tests 2. Check bed-to-bed and bed-to-central station alarm networking (where appropriate). standby.) 60 Hz or other noise (interference) should not be superimposed on the baseline with the ECG simulator attached. 2. 4 Inspection and Preventive Maintenance System ©1995 ECRI.1 Grounding Resistance. If the device has an alarm-silence feature. Using simulated ECG rates of 60 and 120 pulses per minute.24 Direct Writer. Chassis leakage current to ground should not exceed 300 µA. as well as the operation of a volume control. labels.20 Alarms. and record the maximum leakage current. Perform the 1 mV Figure 1. . If the system is modular. dark and thin) at all paper speeds. 119 to 126 bpm). Depress and hold the 1 mV calibration button for about 3 sec (or apply an external 1 mV pulse if the unit does not have a calibration pulse). At a 20 mm deflection. electrical safety analyzer. 1. 1.

and input isolation tests. it is most significant to measure the CMRR at or near that frequency. Since most common mode voltage in the hospital is at 60 Hz. The CMRR is defined as: CMRR = Differential mode deflection factor or DMD (MM / mV) Common mode deflection factor or CMD (MM / mV) 3. either annually or every other year. respectively. If the battery is replaced. if required. Common mode rejection is needed in monitors because of the presence of stray signals common to all input leads primarily at power-line frequency (60 Hz). to simulate unequal impedances in the electrode/skin interface of the monitor electrodes. Signal input test setup. even after charging for 12 hr or more. Figure 2. A frequency of 55 Hz is often used to minimize interference from line frequency noise. Measure the deflection (mm).4 Clean the exterior. mark the date of the replacement on the battery or unit. Preventive maintenance 3. the differential mode deflection factor expressed in mm/mV is numerically equal to the resultant deflection in mm. The ECG monitor includes a differential amplifier so that it can display the voltage difference between two electrodes (the RA and LA in lead 1) while using a third electrode (RL) as a reference. Most ECG monitors should meet the requirements for isolated input devices for ECG lead-to-ground. there should be no output from the differential amplifier because the voltage difference between the two inputs is zero. Perform the inspection after battery replacement and a suitable charge period. Use an unbalanced CMRR measurement that includes a 5. prophylactic battery replacement. While these signals are too minute to be hazardous. If any of the test procedures indicate a weak or defective battery. if needed.000 Ω resistor in series with one of the input leads to the monitor. perform the following tests. Lubricate the chart recorder paper drive per the manufacturer’s recommendations. Inspection and Preventive Maintenance System ©1995 ECRI. they can interfere with the ECG display of a monitor with a low CMRR at 60 Hz. interlead.and high-rate alarm settings of 40 and 120 bpm. Replace filters and batteries. as commonly occurs in practice. For typical low. Some users have also reported that periodic.1 Common Mode Rejection Ratio (CMRR). In addition. Record the frequency on the inspection form. A deflection factor is the change in trace position corresponding to a given input voltage to the monitor. voltage is applied to RA and LA simultaneously.1 3. or common. replace the battery. If the same. verify that the alarm activates when the input rate is set just below or above the respective rate alarm settings. The extent to which a differential amplifier produces no output when the same signal is applied to both inputs is called its common mode rejection ratio. Some units have air filters that accompany the cooling fan. Do not vary the gain of the monitor or the signal frequency for the remainder of this test. and platen. The difference between the rate displayed on the rate indicator and that at which the alarm is activated should not exceed 5% or 5 bpm. Use the same setup as for the previous test.2 3. Using the test setup shown in Figure 2. These filters should be checked and replaced if needed. Since the input signal for this measurement is 1 mV. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. All Rights Reserved. if required. 4. Turn the monitor gain so that the deflection is at least 20 mm. and record it on the inspection form as the differential mode deflection factor. 4. rollers.11 Rate Alarm. whichever is greater. apply a sinusoid test signal of 1 mV peak-to-peak at about 60 Hz to the monitor.ECG Monitors 2. increases reliability and decreases service calls. 5 .

3 6 Inspection and Preventive Maintenance System ©1995 ECRI. verify that the QRS detector circuit is functioning properly. Paper speed should be accurate to within 2%. For example. Quickly change the simulator rate to 120 bpm and use a stopwatch or a watch with a second hand to measure the time until the alarm sounds. The monitor should reliably detect all beats and should not double-count. Battery Operating Time. Units should meet requirements with all functions operating (including alarms sounding) unless otherwise specified by the manufacturer. First. alarm delays should not exceed 10 sec.2 Gain. Common mode rejection ratio test setup. check that it is functioning properly as evidenced by the need to change the setting during this test.6 Before returning to use Return controls and alarm limits to their original positions.000:1.000 msec (60 bpm on an ECG simulator). change rate from 60 to 30 bpm). . If the monitor has a QRS indicator or beeper or a heart rate meter. The other output terminal is grounded.11). If the unit has a manual sensitivity control. Test both the monitor display and recorder.Inspection and Preventive Maintenance System Use the test setup shown in Figure 3 for the second part of this measurement. Use an ECG simulator set to 60 bpm or a signal or pulse generator that has been set to 1 Hz with a calibrated counter. Vary the output amplitude over a range of 0. Figure 3. 4. In addition to checking rate alarm accuracy (Item 2. Check the low-rate alarm similarly (set alarm for 40 bpm. the distance between the first and last of five successive peaks should be 100 ±2 mm. measure the CMRR with the unit resting on a grounded metal plate.5 to 5 mV (use the monitor display to estimate amplitude if the simulator does not have a calibrated output). Verify that the displayed signal size changes appropriately (within 10%) as the gain setting is changed. set the high-rate alarm to 100 bpm and the ECG simulator to 60 bpm.15 mV. At a chart speed of 25 mm/sec and a pulse interval of 1. CMRR should meet the manufacturer’s specification and be at least 10. an appropriate correction should be made in calculating paper speed. 4. use the same test setup to determine alarm delay. Alarm Delay. if a 2 mV signal produces a 20 mm deflection (at a ×1 gain). Increase the amplitude of the sinusoid signal (10 V peak-to-peak) until some measurable deflection is observed on the monitor. Calculate the common mode deflection factor by dividing the resultant deflection (in mm) by the input signal (in mV). 4. Apply a 2 mV signal at a gain setting of 10 mV/mm (or ×1) and measure the displayed amplitude with a transparent scale. It should not detect QRS amplitudes of less than 0.5 4. If the unit can operate on battery power. 4.4 Paper Speed. the deflection should be 36 to 44 mm at ×2. It is essential that all instruments used in this test be connected to Connect an ECG simulator with variable output to the monitor and set it for a rate of 60 bpm. All Rights Reserved. If the unit has an ungrounded or plastic case. Note that there is only one connection from the output of the attenuator to the patient leads. QRS Sensitivity. a common ground to minimize noise.000 msec. If the interval between pulses is not within 10 msec of 1. the distance between the first and the last of five successive peaks should be 200 ±4 mm. and make sure that the unit is not left in a service mode. The CMRR can then be calculated as the differential mode deflection factor divided by the common mode deflection factor. verify that it meets hospital or manufacturer specifications for operating time. at a chart speed of 50 mm/sec. Check the battery condition meter indicator on battery-powered units to verify that there is adequate charge. Generally.

see Procedure/Form 439) Risk Level: ECRI Recommended. The ECRI procedures given in the sections on Ground Potentials and Grounding Resistance below cover both of these requirements. Hospital Assessment.) NFPA 99. Section 3. reliable means of connecting and disconnecting an electrically powered device Permit only devices intended for use with that supply to be connected Allow only one orientation of plug contacts in the receptacle Have low electrical contact resistance between the plug and the receptacle Withstand normal use and reasonable mechanical abuse 094735 437-0595 A NONPROFIT AGENCY 5200 Butler Pike. A recent study by ECRI of more than 800. polarity. Initially.org . However. ECRI-Recommended Interval: See Overview below for NFPA requirements and ECRI recommendations Overview A defective or deteriorating electrical system exposes patients and staff to the risk of electrical shock and potential interruption of power required to operate medical equipment. Hospital Grade [15-859] Also Called: Electrical outlets Scope: Applies to three-wire parallel-blade grounding-type electrical receptacles used in grounded electrical distribution systems throughout the hospital. retention force of the grounding blade. ECRI believes that the testing interval can be extended if fewer than 2% of the receptacles in an area require replacement or other corrective action. Plymouth Meeting. (Note that NFPA 99 requires semiannual testing in wet areas in existing facilities that are not supplied with special protective systems.5. such as ground fault circuit interrupters [GFCIs] or isolated power. 1993 Edition. Low. specifies that voltage and impedance tests be performed to measure the effectiveness or quality of the grounding system. Annual testing should be adequate in areas where receptacles receive frequent use.1 require that the physical integrity.000 receptacles inspected between 1987 and 1994 indicates that more than 13% failed to meet one or more of the criteria in this procedure.5.2.6. specifies that receptacles in general care areas be tested every 12 months and that those in critical care areas and designated wet locations be tested every 6 months. Although there is no formal guideline on an acceptable number of defects. does not apply to explosion-proof or other special types of receptacles (for information on testing of isolated power systems. A power plug and receptacle combination should: Provide a safe. (See the Patient Care Areas box for explanations of the italicized terms used in the NFPA standard. little is known about the history of these receptacles. This section specifies that these tests be performed before acceptance on all new construction and when the electrical system has been altered or replaced.) NFPA permits extending the intervals if documented performance data justify longer intervals. and continuity of the grounding circuit of each receptacle be verified every 12 months in general care and wet locations and every 6 months in critical care areas.3. other areas may require even less frequent testing. Sections 3.Procedure/Form 437-0595 Electrical Receptacles Used For: Receptacles. A periodic inspection program designed to detect and correct deficiencies at each receptacle is required to reduce these risks. The data obtained during these initial inspections should then be examined and used to determine appropriate intervals.2. NFPA 99. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. inspections should be conducted at the specified 12. PA 19462-1298.and 6-month intervals.1.2.2 and 3.

parallel-blade grounding-type receptacle is most familiar because of its widespread use. and similar areas in which it is intended that the patient shall come into contact with ordinary appliances. intensive care units. it may also be intended that patients be connected to electromedical devices (e. examining rooms.Inspection and Preventive Maintenance System Patient Care Areas In specifying testing requirements for electrical receptacles. three-wire. and entertainment devices. delivery rooms. examining lamps. Only two conductors are required to operate a 120 V device. and two-wire parallel-blade plugs and receptacles have been in common use for many years.g. By connecting the equipment chassis to ground. groundingtype receptacle is intended for branch circuits rated at 2 Inspection and Preventive Maintenance System ©1995 ECRI. and similar areas in which patients are intended to be subjected to invasive procedures and connected to line-operated electromedical devices. This conductor. Current electrical codes for new construction require that the ground terminals of all receptacles in patient care areas be connected to ground by a separate insulated copper conductor. At the equipment end of the cord. In such areas. The receptacle ground terminal can also be grounded by a separate grounding conductor connected to the grounding point in the electrical distribution system panel board. a telephone. The other conductor. clinics. Routine housekeeping procedures and incidental spillage of liquids do not define a wet location. otoscopes. The third conductor in a three-wire power cord for conventional equipment does not carry normal load current. monitors. This grounding wire (not to be confused with grounded connector). colored white. . because the conduit is made of a material that can corrode and has mechanical joints that can loosen. and mobile x-ray units. operating rooms.) Ensure that the grounding pin on the plug cap is the first to engage and the last to disengage in the receptacle at all angles of entry and withdrawal Provide strain relief for the power cord where it enters the plug cap Several plug and receptacle configurations are available for specific applications. the third wire is connected to ground. This configuration can be made to satisfy the requirements for a reliable plug-receptacle combination. dialysis units. which generally have higher current or voltage ratings. these terms are explained below. coronary care units. usually green. it connects to the chassis and exposed metal. Because load current does not normally flow through it. The grounding slot of the receptacle is attached to the yoke with which the receptacle mounts in its box. this third wire protects people touching the chassis against electric shocks.. critical care areas. from the hot conductor to the chassis. the green wire will be closer to ground potential than the neutral wire. Explosion-proof plugs and receptacles are required in operating rooms where flammable anesthetics are used and in other areas where arcing when inserting or removing a plug could ignite flammable gases. Operating rooms. is intended to carry normally small leakage currents. this includes standing fluids on the floor or drenching of the work area. Its voltage is approximately 120 V with respect to the neutral conductor or ground reference. peripheral intravenous lines). ophthalmoscopes. parallel-blade. NFPA refers to general care areas. (Note: Areas that may typically be designated as wet locations include hydrotherapy areas. Other receptacle configurations. All Rights Reserved. and certain wet laboratories. is commonly called the neutral wire but is frequently referred to in codes as the grounded conductor. One of these conductors is connected to earth ground near the point where the power enters the building. are used in hospitals for housekeeping equipment. Wet locations are patient care areas that are normally subject to wet conditions while patients are present. treatment rooms. The separate wire. or pulled ground. The two-pole. such as a nurse call system. as well as large fault currents resulting from shorts. When the plug is inserted into a properly installed three-slot grounding receptacle. is a more reliable means of grounding. heating pads. drainage pumps. is called the hot conductor and is usually colored black. electric beds. cardiac catheterization laboratories. Critical care areas are those special care units. An exception to the code allows existing construction that does not use a separate grounding conductor to continue in use provided it meets the specified grounding performance requirements. even though there may be significant amounts of spilled fluids. and the box is grounded through the metal conduit through which the wires run. either of which condition is intimate to the patient or staff. carrying power to the receptacles. General care areas are patient bedrooms. angiography laboratories. and wet locations. electrocardiographs. are generally not considered wet areas. The common three-slot. food carts.

the polarization ensures that the hot. Certainly. corridor. The 20 A receptacle is designed to accept both the 20 A and 15 A plugs. qualified personnel can follow up by correcting defective receptacles and retesting. 22:420. Consult clinical personnel before disconnecting patients from devices or unplugging equipment and before turning off a branch circuit breaker to correct defective receptacles. If no defects are encountered in an area or room. Hospital Grade duplex receptacles [Evaluation]. this may be a room. record the total number of outlets inspected Test apparatus and supplies Three-lamp receptacle wiring polarity tester AC voltmeter. 3 . resolution to 0. the output of the testing devices should be limited to 500 mV RMS (1.g. Receptacles should be tested with all equipment unplugged. Inspection and Preventive Maintenance System ©1995 ECRI. Exception reporting can save time when using the form. You need only record measurements that fall outside the criteria for any test in the appropriate box on the form. such minor defects as a loose screw on the cover plate should be corrected. Devices used to determine ground quality or grounding impedance apply power to the grounding circuit. range 100 to 140 V Low-resistance ohmmeter. If failures occur. OR renovations and the use of isolated power and explosion-proof plugs [User Experience NetworkTM]. note these on the form and identify the location of the receptacle.. 1978 Nov. return when the bed is unoccupied or occupied by a patient better able to withstand the transfer of devices to alternate power sources. 1973 Mar. Identify the area to be tested. Using a standard method for numbering the receptacles in an area will prove helpful. proceeding clockwise around the area. Assuming that the receptacle and equipment are wired correctly. Thus. 8:3-18. One way is to enter the area and start to the left of the door. write OK in the “Status” box and check off the “Exception Reporting Used” box. Because the Universal Inspection Form does not apply.Electrical Receptacles 15 A.2 Ω range Leakage current meter or voltmeter capable of measuring 20 to 500 MV Receptacle tension tester Leads and adapters to connect receptacle and other ground points GFCI tester (electrical safety analyzer or isolated power tester) Defective receptacle tags Test equipment that combines the function of the above test devices or that automates the testing described in this procedure is available and may be substituted. Inspecting personnel might also carry a supply of new receptacles and cover plates and replace and retest defective receptacles as identified.4 VDC even under open-circuit conditions. The conventional three-prong plug and three-slot receptacle are polarized so that they will mate in only one direction. Receptacles and plugs of a slightly different configuration are available for branch circuits and equipment that require between 15 and 20 A. 2:112-5. inspectors can identify defective receptacles with “Defective — Do Not Use” tags. Electrical outlets in anesthesizing locations. use the special Electrical Receptacles Form 437 included with this procedure. coronary care unit. If a defective receptacle is not repaired or replaced at the time of inspection. determine the extent to which inspecting personnel should correct deficiencies on the spot. indicate the area. neutral. Citations from Health Devices Ground fault circuit interrupters [Evaluation]. put a “Defective — Do Not Use” tag on it. special care area. Alternatively.4 V peak to peak) or 1. which is adequate for most 120 V devices. Special precautions Testing in occupied areas must not pose a hazard to patients. and outlet on the form. and ground wires in the power cord connect to their counterparts in the receptacle. equipment requiring polarization is equipped with plugs that have blades of different sizes. or an area with many receptacles (e. If you are planning to adjust the inspection intervals. 21:334. 1993 AugSep. Do not attempt to unplug life support and critical monitoring devices that are in use. All Rights Reserved. but the 20 A plug cannot be used in a 15 A receptacle. room. The conventional two-slot receptacle provides for polarization by the difference in the size of the receptacle slots (the hot wire slot is smaller than the neutral slot). 1992 Sep. isolated power system). To minimize risks to the patient and equipment in the testing area and potentially in other areas served by the same circuit. Procedure Before beginning the receptacle inspections.01 Ω in the 0 to 0.

Replace the cover plate if it is cracked. rule out any defect in the equipment that causes it to draw excessive current or poor connections in the plug cap. Measure ground potentials with a voltmeter or leakage current meter. and differences of less than 20% should be considered insignificant. Repeating the tests after typical loads are applied or in existing facilities may indicate poor wiring or inadequate system capacity. or loose wiring. If the space provided on the form is inadequate. identify the defective outlet on the form and indicate the need for corrective action in the “Comments” column. especially if improper techniques have been used with aluminum wiring. Leakage current readings can be converted to millivolts if the leakage current meter’s Wiring polarity Check each receptacle for wiring errors with a threelamp polarity tester. Measure the AC voltage between the neutral and ground connections. A reading of above 4 V indicates possible miswiring of the neutral and/or ground systems or excessive resistance in the wiring. and attach them together. Be sure to include the receptacle number on all such notes. and withdrawn. damage. including high resistance at the receptacle contact due to wear. Mechanical condition Visually inspect the receptacle and cover plate for physical damage and security of physical mounting of the receptacle and outlet box. except Ground Potentials and Grounding Resistance. If any sensation of heat is noted when touching the surface of the receptacle or when unplugging connected equipment. renovations. All Rights Reserved. These tests should be performed following new construction. neutral. or ground wires and whether hot and neutral or hot and ground wires have been interchanged. you may want to perform all of the tests. Correct any defects in physical mounting. Such flickering may indicate poor contacts and should be investigated. 4 Inspection and Preventive Maintenance System ©1995 ECRI. It should not fall below 100 V with heavy loads on the circuit or rise above 130 V during no-load conditions. the voltage should not exceed 500 mV in general care areas and 40 mV in critical care areas. jiggled moderately in place. Use an AC voltmeter to measure the hot-to-neutral voltages at representative receptacles in an area or in the branch circuit panel board. on each individual receptacle in a room or area. number each sheet. In existing construction. . Heating within the receptacle can be caused by several deficiencies. A significant difference in line voltages to receptacles taken under typical load conditions indicates overloaded circuits or faulty wiring and requires further investigation. Caution: Consult clinical personnel before unplugging any equipment. investigate further. These voltage differences could be caused by high ground-to-ground resistances and/or heavy currents flowing through the ground system. Look for flickering of the tester’s lights as it is inserted. The hot-to-neutral voltage should normally be within the 115 to 125 V range. Before condemning the receptacle. then proceed with the remaining tests on all receptacles. Correct any wiring errors. For new construction. To save time. voltages in modern construction are usually less than 10 mV. Inspect every receptacle in the area with all equipment unplugged from the receptacle under test. An optional means of testing for adequate wiring is to measure the line voltage with and without a load connected to the other half of the duplex receptacle being tested. voltages exceeding 20 mV may indicate a deteriorating condition and should be investigated. Line voltage The following line voltage tests are not required by NFPA 99.Inspection and Preventive Maintenance System (use the margin) so that the percentage of defective receptacles can be determined. Rarely will a receptacle develop internal leakage. Ground potentials The purpose of this test is to determine whether voltage differences exist between points that should be at ground potential. write “See note” in the block and use the back of the form. It does not detect neutral/ground reversal and does not verify that grounding is adequate to carry fault currents. However. This tester will indicate loss from hot. We have included them as optional tests. or major repairs to the electrical distribution system to ensure that voltage taps are set correctly on distribution transformers. If deficiencies are found. NFPA 99 requires that the voltage limit between a reference point and grounding contact of each receptacle in the patient vicinity not exceed 20 mV. It should be understood that these limits are not precise. The tests may also be helpful in diagnosing suspected problems and indicating whether a more extensive investigation of the electrical distribution system is necessary. Replace the receptacle if its face is badly chipped or broken. If more than one form is needed for an area.

since the outlet ground contact will usually be grounded through the conduit).01 Ω may be used. For example. The purpose of the grounding resistance test is to determine whether the grounding circuit resistance is low enough to serve its intended function. If the neutral-to-ground resistance were low. loss of contact Inspection and Preventive Maintenance System ©1995 ECRI.4 VDC. the measurement current can be either AC or DC. in new construction. Several test devices are available using different measurement methodologies. Grounding resistance The three-lamp testers used to check receptacle wiring as part of the basic inspection will indicate the complete lack of ground. a ground whose resistance is as high as several thousand ohms may be considered acceptable by these testers. carry sufficient current to quickly blow the branch fuse or circuit breaker. (Most leakage current meters have a 1. It is usually most convenient to use the ground contact of one receptacle. In this application. All Rights Reserved.000 Ω impedance at line frequency. More recently. note the appropriate criteria for new construction included in those test methods. rather than while performing other tests on each receptacle. should not exceed 0. the reading in µA is then numerically equivalent to the voltage in mV. Plugs with bent blades may not make electrical contact at all. 5 . but a ground plug or structural member can also be used. the ground must Contact tension Contact tension — the force with which the spring contacts of the receptacle grip the blades of the plug — affects the performance of the plug/receptacle combination both electrically and mechanically. The need for corrective action should be discussed with the plant engineer or other responsible person. will often be undetected during ground potential measurements. the grounding system resistance must be low enough to prevent dangerous voltages when anticipated leakage or fault currents flow through it. low-resistance electrical connections cannot be assured. To save time. Select a ground reference point (such as that used for the ground potential test). In this application. ECRI suggests a minimum of 1. then the heavy currents flowing from the grounded chassis back to the neutral wire would trip the receptacle’s circuit breaker. Connect the other lead to the ground contact of each receptacle in turn. Neutral-to-ground resistance The safety provided by a good ground system can be compromised if the neutral wires of the receptacles are not properly connected to the grounding system at an appropriate location. since the equipment will not function.0 Ω between the neutral and ground contact of each receptacle. High resistance in the hot and neutral connections can cause internal heating of the receptacle.2 Ω and. any device used to determine ground quality or grounding resistance on occupied patient care areas must limit the output to 500 mV RMS (1. If contact tension is insufficient. reliable. To avoid risk to patients in the area in which testing is being conducted and in areas distant from the testing site. A high ground potential measurement at a receptacle grounding contact may indicate that the ground and the neutral conductor in the receptacle wiring are reversed. However. Originally. For periodic measurement in existing construction. and measure the resistance between each receptacle ground contact and the reference. The three-lamp testers will not detect such reversal (which. in fact. Do not use the cover plate screw because this may not be adequately grounded. Any of these special-purpose devices or an ohmmeter with resolution to 0. Action required as a result of ground potential and grounding resistance failures may not be restricted to replacement of a receptacle but may involve the entire area’s wiring and grounding.Electrical Receptacles impedance is known. if a device plugged into a receptacle with high neutral-to-ground resistance develops a hot-wire-to-chassis short circuit. When performing ground potential and resistance tests on new construction and renovations. NFPA 99 requires the use of an AC measuring source for postconstruction impedance measurement (but allows the use of AC or DC devices on existing construction). The resistance should not exceed 0. then 120 V would exist as a shock hazard to anyone touching that chassis.1 Ω. Ground potentials will not be constant with time but will depend on what equipment is connected and operating at the time of measurement.4 V peak to peak) or 1. the ground contact in a receptacle was designed to prevent the chassis of connected equipment from becoming energized in the event of a lineto-chassis fault. However. This will be easily recognized with the hot and neutral blades. measure ground potentials on an entire room or area at one time. the grounding system has been called upon to drain leakage current and fault currents not large enough to blow a fuse or breaker and to protect hospital patients against microshock under these conditions.) Connect one lead of the meter to a reference ground point that is known to be securely grounded.

under fault conditions. thus causing the difference to increase. and simple GFCI test devices are available commercially. Ask the manufacturer about probe sizes and finishes. 8 µ in finish (UL). it interrupts the circuit to the receptacle. many electrical safety analyzers and isolated power test devices have a built-in test for GFCIs.055 to 0. The GFCI test procedure is included 6 Inspection and Preventive Maintenance System ©1995 ECRI. calibrate the tester to ensure accuracy. GFCIs A GFCI is a device designed to interrupt the electrical circuit to the load when a fault current to ground exceeds some predetermined value that is less than that required to operate the overcurrent protective device (fuse or circuit breaker) of the supply circuit.1397 to 0. UL and ANSI values may serve as guidelines for hospitals: — Ground probe — cylindrical. and adjust if necessary. although this is not required. this difference is quite small. check its scale reading. In addition. We offer the following suggestions for purchase and use of these devices: Check for an appropriate test range of up to at least 8 oz. Before each receptacle inspection.065 in) thick (ANSI). Also. The use of GFCIs is an acceptable method of reducing macroshock hazards in areas designated as wet locations. measurement inaccuracies.4674 to 0. 0. the contact tension must be sufficient to prevent the plug from inadvertently coming out of the receptacle. and forces of 2 to 4 oz are satisfactory if the plug brand in use tends to stabilize at this value and does not continue to deteriorate. Carry alcohol wipes and clean the probes periodically. current returns to the source by a path other than the neutral wire. Many GFCIs have a built-in test circuit and reset button. Retention force on the ground prong must be 4 oz or more. GFCIs are used for added protection against macroshock hazards in areas where the risk of these hazards is increased due to environmental conditions.190 in) diameter. be sure the probes are clean and dry. They should be made of tool steel or a metal of equivalent hardness. such as the presence of water. If such a circuit is not built into the receptacle or for a more accurate validation. Thus. Measure contact tension on each receptacle while withdrawing the tester straight and smoothly from the outlet. many testers are not rugged enough to survive transport in a tool box. Also. Normally. The GFCI continuously senses the difference in current flow between the hot and neutral wire of the receptacle circuit. When using the tester. as an additional test that applies only to receptacles protected by a GFCI. Though directed at manufacturers. contact tension should not be so great that the plug cannot be easily inserted or withdrawn. (See the Contact Tension Testers box.) Contact Tension Testers Contact tension testers are available in many configurations and brands. It has been shown that good electrical contact requires a lower gripping force than is needed to grasp the plug firmly. NFPA specifies that a device or component that causes 6 mA of current to flow to ground shall be momentarily connected between the energized conductor of the power distribution circuit being protected and ground to verify that the GFCI does indeed interrupt the power. in the event that someone trips over a line cord. a mechanical test of tension is sufficient. When the GFCI senses that this difference is greater than some critical value (usually 6 mA).184 to 0. Inaccurate probe sizes and surface finishes. Make sure that the tester has a specified accuracy or is accurate to within 10%. NFPA 99 specifies that GFCIs used in wet locations be tested at least every 12 months. On the other hand. the plug should withdraw from the outlet. — Power probe — 0. Inadvertent lubrication can significantly affect readings. In many cases. We recommend measuring the retention force on the hot and neutral prongs. All Rights Reserved. Suspend a known weight from the tester. The device is usually installed as part of the electrical wiring supplying power to a receptacle. rather than the equipment being pulled down or the line cord severing. A retention force of 4 oz is also adequate for the hot and neutral prongs.4826 cm (0. . We believe this is an adequate test for routine testing.Inspection and Preventive Maintenance System on the ground will not be obvious and will compromise the safety of the equipment. and poor repeatability can cause erroneous results. However. it is an integral component of the power receptacle.1651 cm (0.

Procedure/Checklist 410-0595 Electrocardiographs Used For: Electrocardiographs. Plymouth Meeting. Voltage levels and timing between events are measured with calipers or automatically by the electrocardiograph. which should be inspected with the ECG monitor or the defibrillator/monitor they are used in conjunction with (use ECG Monitors Procedure/Checklist 409 and Defibrillator/Monitors Procedure/Checklist 408. Hospital Assessment. Therefore. Medium. an electrocardiogram (ECG). Portable and mobile electrocardiographs deserve special attention. By using a high-fidelity recording of multiple leads. EKG machines Commonly Used In: Electrocardiography departments.org . experience indicates that most of these characteristics do not change on modern electrocardiographs unless there is a major (and usually obvious) equipment failure. Interpretive [16-231] Electrocardiographs. Multichannel [11-411] Electrocardiographs. Each portion of the ECG is directly related to an electrical cardiac event. hours hours Overview An electrocardiograph detects the electrical activity of the heart and produces a graphic record. it is possible to accurately examine and quantify rhythm and waveform morphology. Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . respectively) Risk Level: ECRI Recommended. ECG units. may also be adapted for some systems that digitally store data and later provide hard-copy tracings. . While verification that an electrocardiograph meets these criteria is an important part of a prepurchase evaluation program and should be included as part of acceptance testing. Comparing the various lead signals provides a more specific and accurate diagnosis than would be possible with a single-lead recording. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. Several standards and guidelines include performance criteria to ensure that recording errors do not interfere with accurate interpretation of the ECG. PA 19462-1298. is called a lead. Each ECG trace. of voltage versus time. A full-lead ECG records 12 leads derived from 10 electrode locations. emergency departments. Single-Channel [11-413] Also Called: EKG units. and variations or abnormalities seen in the ECG can often be traced to a particular site in the heart. the inspection procedure has been designed to reduce the amount of testing required. does not apply to strip-chart recorders or direct writers. not suitable for verifying performance of automated diagnostic functions. rough handling may change circuit 009028 410-0595 A NONPROFIT AGENCY 5200 Butler Pike. which is derived from the electrical activity detected by two or more electrodes placed at certain points on the patient’s skin surface. and most patient care areas Scope: Applies to single-channel and multichannel electrocardiographs typically used for recording an electrocardiogram on paper.

All Rights Reserved. Because this Procedure/Checklist covers electrocardiographs used in their conventional application and not as components of larger systems. Examine the strain reliefs at both ends of the line cord. 13:254. 3:31-56. Inspect the cord for signs of damage. and power cords and plugs. cut out the defective portion. 1. If it is attached to a wall or rests on a shelf. Also check line cords of battery chargers. Be sure to wire a new power cord or plug with the same polarity as the old one. Although this source should include a current-limiting resistor. 1990 Sep. galvanometer. While units that show deteriorating performance or safety should be repaired or replaced. that necessary assembly hardware is present and tight. realistic levels of safety. Signal-averaging ECGs: An update. check the security of this attachment.6 2 Inspection and Preventive Maintenance System ©1995 ECRI. Examine the exterior of the unit for cleanliness and general physical condition. Attempt to wiggle the blades to determine that they are secure. 1991 Oct. Test apparatus and supplies ECG simulator with calibrated output amplitudes and rates Ground resistance ohmmeter Leakage current meter or electrical safety analyzer Contact cleaner and lubricant Counter (optional) The following equipment is necessary during acceptance testing only: Function generator Attenuator Oscilloscope Transparent metric scale Isolation test supply (included in some electrical safety analyzers) 1. and that there are no signs of spilled liquids or other serious abuse. Casters/Brakes. Encourage ECG technicians to check their instruments at the start of each shift and to ensure that the units are clean when returned. those that meet their original design specifications may still be suitable for use. if the unit is so equipped. Line Cord. check their condition. chart drive or paper feed. take into account clinical needs. if the damage is near one end. If any damage is suspected. open the plug and inspect it. replace the entire cord or. 20:367-408. Three-channel electrocardiographs [Evaluation]. Citations from Health Devices Single-channel electrocardiographs [Evaluation].2 1. 19:328-30. 1984 Aug. Be sure that they hold the cord securely. Check the operation of brakes and swivel locks. Mishandling frequently damages the delicate writing stylus.5 Procedure Before beginning an inspection. as appropriate. test them for performance characteristics that pertain to the specific application. Look for accumulations of lint and thread around the casters. Be sure that plastic housings are intact. carefully read this procedure and the manufacturer’s instruction and service manuals.1 Chassis/Housing.3 1. If these are used. If the device is mounted on a stand or cart. 1.Inspection and Preventive Maintenance System characteristics and adversely affect recording or safety. be sure that you understand how to operate the equipment and the significance of each control and indicator. 1. . 12-lead multichannel interpretive electrocardiographs [Evaluation]. 13:235.4 Special precautions Testing input isolation requires the use of a linevoltage source. AC Plug. Mount. and funding priorities. Defibrillating patients connected to electrocardiographs. Qualitative tests 1. Strain Reliefs. examine the condition of the mount. if applicable. Shake the plug and listen for rattles that could indicate loose screws. If the device moves on casters. 1973-74 Dec-Jan. and be sure that they turn and swivel. use caution to avoid contact with any portions of the energized circuit. When evaluating these units. If damaged. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Some older electrocardiographs may fail to meet current criteria for performance and safety. auxiliary inputs or outputs of the writer are not tested here. 1984 Aug. Examine the AC power plug for damage.

Where a control should operate against fixed-limit stops. 1. check for proper alignment. (Up to 10% spike or overshoot is acceptable but will usually not be observed in a unit that is functioning optimally. Check the condition of the battery charger. Slight rounding (middle) or small overshoot is acceptable. Be sure that all segments of a digital display function.11 Electrodes. 1.10 Fittings/Connectors. If this is recommended by the manufacturer. confirm that it does.g. Examine all controls and switches for physical condition. The calibration pulse or step response leading edge should have square corners (left). 1. Examine all cable connectors for general condition.. in fact.. a filter switch in the monitor mode rather than the diagnostic mode). charge the battery. When it is necessary to replace a battery. check its value and type against that marked on the chassis. from fingernails. The trace should exhibit a sharp. 1. check their positions. indicators. if so equipped. Excessive rounding or overshoot (right) indicates the need for adjustment. and to the extent possible. and verify that an adequate trace is received at each patient lead selection.17 Battery/Charger. label it with the date. square-cornered leading edge that is neither rounded nor spiked.g. check that it moves freely. Check operation of battery-operated power-loss alarms. confirm the operation of all lights. secure mounting. pens). Check that control knobs have not slipped on their shafts. consider the possibility of inappropriate clinical use or of incipient device failure. the pulse should have de- 1. see Figure 1.9 Figure 1.19 1 mV Step Response. Inspect the cables and leads for their strain reliefs and general condition. Check membrane switches for membrane damage (e. Some batteries require periodic deep discharges and recharging to maintain maximum battery capacity. During the course of the inspection.13 Controls/Switches. (Checking all leads in some units will require either a 12-lead simulator or connection and disconnection of every lead. be sure to check that each control and switch performs its proper function. Electrical contact pins or surfaces should be straight and clean.7 Circuit Breaker/Fuse. Confirm that an adequate supply of ECG electrodes is available.18 Indicators/Displays. as well as positive stopping. Perform the inspection with the unit on battery power or operate the unit on battery power for several minutes to check that the battery is charged and can hold a charge. Check battery capacity by activating the battery test function or measuring the battery-powered operating time. If the device has a switch-type circuit breaker. If any appear inordinate (e. If the device is protected by an external fuse.Electrocardiographs 1. All Rights Reserved. 3 . Depress and hold the 1 mV calibration button (or apply an external 1 mV pulse) for about 3 sec. 1. Record the settings of those controls that should be returned to their original positions following the inspection. Connect the unit to an ECG simulator.) Flex the patient cable near each end to verify that there are no intermittent faults. Inspection and Preventive Maintenance System ©1995 ECRI. verify that it is being performed on schedule. Before moving any controls. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors of each end to prevent rotation or other strain. and check their physical condition and that they are within their expiration dates. Inspect the physical condition of batteries and battery connectors. During the course of the inspection. and visual displays on the unit and charger. if so equipped. Cables. Leads and electrodes should be firmly gripped in their appropriate connectors. and correct motion. and ensure that a spare is provided.) After 2 sec (50 mm of paper at a speed of 25 mm/sec). 1. if readily accessible.

An ECG simulator can be used. The lower trace indicates a low-frequency response of between 0.g.23 Accessories. The baseline should remain within 1 mm of its initial position upon pushing the reset control.25 Paper Transport. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. 1. Using an ohmmeter. even if its output is not precisely 1 or 2 mV. it should be horizontal and not drift vertically. The upper trace indicates a low-frequency response of about 0.24 Trace Quality. 1. cayed to no more than half its original amplitude (see Figure 2 on page 4). Sag time is measured to the half-amplitude point. check its output with a precision voltmeter or similar instrument to confirm that the output is not affected by changing battery voltage. All Rights Reserved. Verify that an adequate supply of electrodes and paper and a fuse are stored with the device or in the nursing unit for those electrocardiographs that remain in a fixed location. verify that all alphanumerics and tracings appear in the correct location and that the paper starts and stops at the correct points. Check that all necessary placards. Chassis Leakage Current.e. With sensitivity at 20 mm/mV. Quantitative tests 2. provided its amplitude is accurately known and appropriate corrections are made in interpreting the results. A spare patient cable and stylus (or pen) may be kept with units on crash carts. .. the operator-adjustable stylus heat control should function and should not 2.2 2. We recommend a maximum of 0. and instruction cards are present and legible. Figure 2. including on. unit prints a single formatted sheet for each electrocardiogram).09 Hz. If this calibration source is battery powered.1 Grounding Resistance. There should be no 60 Hz noise when the lead selector switch is set to the lead 0 or standard position and the chart motor is activated. Verify that the paper moves smoothly and without hesitation at all paper speeds. or multimeter with good resolution of fractional ohms. including the P wave and QRS.22 Labeling. except on those units where mechanical stops prevent such travel. Operate the device in all normal modes. Calibration. electrical safety analyzer. The paper should not drift sideways in the transport mechanism. Observe the tracing with the unit in the standard lead select position (no input) and in lead I with a simulated ECG signal applied. record a 1 mV pulse from the external reference generator and one from the internal 1 mV calibration signal of 2. Problems might be caused by the transport mechanism or by a roll of paper that is wound too tightly.3 4 Inspection and Preventive Maintenance System ©1995 ECRI. Chassis leakage current to ground should not exceed 300 µA. measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis.05 Hz.07 and 0. and record the maximum leakage current. 1. If a formatted output is used (i. standby. It should be possible to move the baseline from the lower to the upper border of the chart paper with the vertical position control. and off. 1.5 Ω. labels. Verify compliance with the following criteria: The baseline should have constant thickness. calibrated ECG simulator). This test determines the accuracy of both the sensitivity control and the internal 1 mV calibration signal and requires the use of an external source of known amplitude (e.Inspection and Preventive Maintenance System need to be set near either extreme to obtain a satisfactory setting. If so equipped.. All portions of a simulated ECG waveform should be clearly visible.

If the internally generated pulse and a 1 mV external pulse produce tracings of heights that differ by more than 0.5 mm. In addition. the distance between the first and last of five successive peaks should be 100 ±2 mm. an appropriate correction should be made in calculating paper speed. at sensitivity settings of 2.19). 10.3 3. paper guides. even after charging for 12 or more hours. and knife edges.5 mm.1 Clean the exterior (including front panel controls). Preventive maintenance 3. 1 mV peak-to-peak. 4. Lubricate the recorder mechanism and paper drive per the manufacturer’s specifications. Set the electrocardiograph gain to 10 mm/mV to obtain a peakto-peak deflection of 1 cm. perform the following tests. if needed. set the output for any convenient peak-to-peak display and note the height.7 cm peak-to-peak. the tracing should be between 19 and 21 mm. it is much simpler to determine the low-frequency response point using the step response test (see Item 1.7 cm peak-to-peak. Increase the output frequency from the sinusoidal generator until the display drops to 0. and the 2. Inspection and Preventive Maintenance System ©1995 ECRI. The low-frequency response point can be determined in a similar way by decreasing the frequency from 2 Hz until the display again drops to 0. Calibrate damping and stylus. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. 5 . if required. Signal input test setup.7 3. Because of the difficulty in resolving small errors. Apply a calibrated 2 mV input to the writer. the trace should double in height (within 5%).) Record this frequency as the upper 3 dB point. Paper Speed.2 3. Some units have air filters that accompany the cooling fan. the distance between the first and last of five successive peaks should be 200 ±4 mm. and input isolation tests. (The waveform may be slightly distorted. Replace filters and batteries.5.000 msec (60 bpm on an ECG simulator).) Measure between the extreme top and bottom of the trace. record 1 mV pulses. 2. The speed should be accurate to within 2%.6 Linearity.7 times the 2 Hz deflection. 5. and 20 mm/mV. at a chart speed of 50 mm/sec. Set the function generator and attenuator for a sinusoidal output of 2 Hz with a peak-to-peak amplitude of 1 mV. For an externally generated pulse of exactly 1 mV. Check and replace these filters. If any of the test procedures indicate a weak or defective battery. Record the deflection at 10 mm/mV.1 Frequency Response.000 msec. If your signal generator output is not easily adjusted. either from the internal calibrator or the reference generator. measure the output amplitude peak-to-peak with the oscilloscope (DC response) to ensure that a constantamplitude sinusoid. However. (The deflection amplitude is not critical. or 0. or 0. Electrocardiographs should meet the requirements for isolated input devices for ECG lead-to-ground. At each setting. if needed. Figure 2. if required. Use the test setup shown in Figure 3. Next. If the interval between pulses is not within 10 msec at a pulse interval of 1. When changing the output frequency of the function generator. 3. Use an ECG simulator set to 60 bpm or a signal or pulse generator set to 1 Hz that has been set or calibrated with a counter. investigate any deviation of more than 0. All Rights Reserved. interlead. replace the battery. At a chart speed of 25 mm/sec and a pulse interval of 1. the internal calibrator is not within the recommended 5% accuracy.7 times the 2 Hz deflection. all rollers.Electrocardiographs the writer. 4. It should be twice the deflection (within 5%) observed for a 1 mV signal. is delivered to the electrocardiograph throughout the bandwidth. Deviation greater than this can often be corrected with the variable gain control (a screwdriver adjustment in many units).4 Figure 3.

apply a sinusoid test signal of 1 mV peak-to-peak at about 60 Hz to the electrocardiograph. The common mode rejection ratio is defined as: CMMR = Differential mode deflection factor. voltage is applied to RA and A deflection factor is the change in trace position corresponding to a given input voltage. The extent to which a differential amplifier produces no output when the same signal is applied to both inputs is called its common mode rejection ratio. 6 Inspection and Preventive Maintenance System ©1995 ECRI. The electrocardiograph includes a differential amplifier so that it can display the voltage difference between two electrodes (the RA and LA in Lead 1) while using a third (RL) as a reference. as recommended by the American Heart Association.27 Hz 0. Some units have selectable frequency response modes.050 0. or common.) Using the test setup shown in Figure 3. Set the gain to 20 mm/mV. Since the input signal for this measurement was 1 mV. Common mode rejection ratio test setup. Since most common-mode voltage in the hospital is at 60 Hz. Use an unbalanced CMRR measurement that includes a 5. 4. In the Filter In mode. This mode can be used to reduce baseline wander and high-frequency noise.and high-frequency qualities of the electrocardiogram than the Filter In (or monitor) mode. The diagnostic response mode provides an expanded bandwidth. If the same. The electrocardiograph should normally be operated in the diagnostic mode.Inspection and Preventive Maintenance System Relationship Between Sag and Low-Frequency Response Distance to Half Amplitude 10 mm 20 30 40 50 55 60 80 Lower 3 dB Frequency 0. While the technique may not accurately predict the low-frequency response of all units. confirm the notch filter’s operation by sweeping past 60 Hz on the signal generator and looking for a sharp dip in the response. This simulates the unequal impedances that usually exist in the electrode/skin interfaces.069 0. or DMD (mm ⁄ mV) Common mode deflection factor. the differential mode deflection factor expressed in mm/mV is Figure 4. (A frequency of 55 Hz is often used to minimize interference from line-power frequency noise. .and high-frequency components of the electrocardiogram are attenuated. If the response increases as the frequency is increased past the notch filter frequency. Common mode rejection is needed because of the presence of stray signals common to all input leads primarily at power-line frequency (60 Hz). The manufacturer’s specification for each frequency response mode should be used as a reference. there should be no output from the differential amplifier because the voltage difference between the two inputs is zero.034 LA simultaneously.092 0.2 Common Mode Rejection Ratio (CMRR). and record it on the inspection form as the differential mode deflection factor.055 0.67 to 100 Hz. it does provide an equally (if not more) clinically relevant response test. The diagnostic mode bandwidth should be at least 0. On such units.046 0. While these signals are too minute to be hazardous. it is most significant to measure the CMRR at or near that frequency.13 0. Some units include a notch filter to minimize 60 Hz noise. they can interfere with the ECG recording on a unit with a low CMRR at 60 Hz. it should not be used when recording diagnostic ECGs. measure the deflection in mm. or CMD (mm ⁄ mV) Relationship Between Sag and Low-Frequency Response table on page 6. but because small distortions of the ECG can occur. then the upper 3 dB point may be above the notch filter frequency rather than occurring where the filter begins to attenuate. low. All Rights Reserved. This should produce a display that reproduces more of the low.000 Ω resistor in series with one of the input leads.

Before returning to use Set all controls to their original settings. 7 .4 Crosstalk. another with the baseline at the middle of the chart.6. Note that there is only one connection from the output of the attenuator to the patient leads.3 Linearity. Inspection and Preventive Maintenance System ©1995 ECRI. Using the internal calibration button. Calculate the common mode deflection factor by dividing the resultant deflection (in mm) by the input signal (in mV). All Rights Reserved. The CMRR may then be calculated as the differential mode deflection factor divided by the common mode deflection factor. and recharge the battery. The other output terminal is grounded. It is essential that all instruments used in this test be connected to a common ground to minimize noise. Do not change the gain setting or the signal frequency for the remainder of this test. Record the frequency. Check for channel crosstalk on multichannel electrocardiographs by attaching an ECG simulator to one lead pair while the others are shorted together. If the unit has an ungrounded or plastic case. Baseline position. Display range. There should be no visible trace deflection in any of the channel tracings except the one with the simulated ECG. if needed. measure the CMRR with the unit resting on a grounded metal plate. In addition to the linearity test described in Item 2. Verify that activation of time and event markers does not cause a deflection on the ECG trace.5 mm with baseline position.000:1. and a third with the baseline as close to the top margin of the paper as possible while still allowing the pulse to remain on the ruled chart. The height of the calibration pulse should not vary more than 0. generate a pulse with the baseline set at the bottom margin of the chart. 4. Note any distortion or clipping of the signal. apply a 5 mV peak-to-peak signal. 4. CMRR should meet the manufacturer’s specification and be at least 10. and observe the trace using gain and position settings that keep the trace on the recording paper rulings. Increase the amplitude of the sinusoid signal (up to 10 V peak-to-peak) until some measurable deflection is observed on the recorder. if possible. Vary the centering or position control to change baseline position.Electrocardiographs numerically equal to the resultant deflection in mm. Use the test setup shown in Figure 4 for the second part of this measurement. Using the test setup shown in Figure 3 (signal generator set to about 2 Hz) or an ECG simulator with an appropriate output range. The monitor should be able to faithfully display signals of up to 5 mV. test the effect of baseline position on linearity and linear input range.

A combination of damped and undamped waveforms cuts and coagulates simultaneously. electrocautery units (although this term more appropriately refers to a different type of surgical device). This type of current can also be used to coagulate with large surface electrodes or hemostats. Damped waves and current bursts coagulate. and the dispersive electrode (also called the butt. safety. PA 19462-1298. fibrous residue left by the rapid dehydration of cells blocks vessels and prevents bleeding. Tesla and Oudin coil resonators in conjunction with spark gaps produced high voltages at very low currents. Hospital Assessment. which were used to destroy superficial tissue with a spray of sparks from the active electrode (fulguration). They also incorporate microprocessor-controlled circuitry to monitor unit performance. adjust power settings. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. to be used only when referring to that device) Commonly Used In: Operating rooms. Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required .0 MHz) cut tissue with a cutting electrode or loop with minimal coagulation. and desiccate with minimal cutting by generating heat in a wider region of tissue immediately surrounding the active electrode. the higher currents required a reliable conductive path to complete the circuit. Most currently marketed units are solid-state devices that permit size reduction and the generation of a variety of waveforms without the use of a spark gap. Plymouth Meeting. Circuits could then be designed to produce lower voltages but higher currents. General-Purpose [16-137] Electrosurgical Units. or return or indifferent electrode) was introduced.Procedure/Checklist 411-0595 Electrosurgical Units Used For: Electrosurgical Units [11-490] Electrosurgical Units. and. . Specialty [16-138] Also Called: ESUs. the heat that destroys tissue is not produced by a heated wire as in electrocautery. coagulation) by using high-frequency electrical currents that pass through the body (units may include other functions such as insufflation). cutting. does not apply to electrocautery units that use an electrical current to heat a tip for surgical effects Risk Level: ECRI Recommended. In electrosurgery. However. but 094428 411-0595 A NONPROFIT AGENCY 5200 Butler Pike.2 to 3. outpatient surgical units Scope: Applies to units that perform surgical functions (e.. The dry. or ground plate. fulgurate. patient. interrogate the quality of contact of the return electrode. High. No return connection was provided between the patient and the electrosurgical unit.org . hours hours Overview Surgical use of high-frequency current dates back to the early 1900s. Undamped. The intense heat explodes and volatilizes tissue cells. in some units. Vacuum tubes were later introduced and provided continuous sinusoidal wave generation. continuous sinusoidal currents (about 0.g. Bovie (a registered trademark of MDT Diagnostic Co.

ESU burns from poor return electrode site preparation [Hazard]. 14:115. Burns and fires from electrosurgical active electrodes [Hazard update]. 11:301-2. 16:35. Active electrodes have small tips to increase the current density at the surgical site. 16:337-9. (See also: 1977 Jun. 1987 Sep-Oct. 1986 May. such as bipolar and laparoscopic forceps and leads. 20:446. 1977 Mar. 1987 Jan. 1988 Dec. 1987 Sep-Oct. 20:496-7. 16:340-1. Adapters and cables for disposable electrosurgical dispersive electrodes [Hazard update]. 1987 Sep-Oct. Return electrode monitors: Assessing your needs [Risk analysis]. 1986 Aug. 9:82. the dispersive electrode must contact a much larger area of the patient’s skin to reduce the return current density to harmless levels. Update: ESU return electrode contact quality monitors [Risk analysis]. Citations from Health Devices Electrosurgical units [Evaluation]. ESU burns from poor dispersive electrode site preparation [Hazard]. Both characteristics can be combined into a single electrode (a blade type) so that electrodes need not be changed during shifts between cutting and coagulation. coagulation electrodes have larger surface areas. 1989 Dec. 18:433-6. 10:74-5. Electrosurgery checklist. 1993 Oct. Birtcher 4400 electrosurgical units and 6400 argon beam coagulation systems [Hazard]. 1989 Dec. 6:59-86. 1991 Oct. 16:341-2. 1981 Feb. 1993 Aug-Sep. Ellman International Manufacturing Surgitron and Surgitron FFPF [Hazard]. Update: Controlling the risks of electrosurgery [Risk analysis]. Fires during surgery of the head and neck area [Hazard]. 15:151. 10:99. Controlling the risks of electrosurgery [Risk analysis]. 9:50. Electrosurgical unit activation tone control [Hazard]. Hand-switched electrosurgical active electrode pencils [Evaluation]. Current density and duration determine the amount of heat generated and tissue destroyed at and near the electric arc. 1993 Aug-Sep. 1986 Jun. 1990 Sep. 14:407. Pacemakers and electrosurgery: What precautions are needed? 1987 Sep-Oct. 1991 Nov. 1977 Jan-Feb. Bovie CSV: Still accepted? 1987 Sep-Oct. 22:422-3. Fires during surgery of the head and neck area [Hazard update]. 15:143. 22:421-2. 18:430-2. 22:502. 1992 Jun-Jul. Isolated incidents: Electrosurgical units [User Experience NetworkTM]. Where practical. 1980 Jan. but they are not usually readily available with the electrosurgical unit. Argon beam coagulation systems [Evaluation]. 1982 Sep. Argon beam coagulation systems [Evaluation update]. 16:335-7. 1985 Feb. 1989 Dec. 17:363-5. 19:444-5. 21:249-50.) Electrosurgical unit safety. 19:299-320. Since no tissue heating is desired elsewhere. 16:342. . users or processing personnel should routinely inspect these items. should be inspected periodically. Electrodes used specifically for cutting have small points or edges to concentrate the electrosurgical current. All Rights Reserved. 20:409-10. Do ESU output characteristics affect instrument performance? 1987 Sep-Oct. Burns and fires from electrosurgical active electrodes [Hazard update correction]. 1979 Dec. Periodic inspection is not a substitute for routine pre-use verification of electrosurgical unit safety features and current use practices. 15:248. Stryker Surgical microsurgical drills: Activation by ESUs [Hazard update]. 1985 Nov. Using two ESUs on one patient [Consultant’s Corner]. 16:291-333. Adapters and cables for electrosurgical dispersive electrodes [Hazard]. Stryker Surgical microsurgical drills: Activation by ESUs [Hazard]. 1990 Dec. Electrosurgical units [Evaluation]. 6:194. 1981 Jan. 18:432.Inspection and Preventive Maintenance System by conversion of the high-frequency electrical energy in the tissue. Electrosurgical units [Evaluation update]. Stryker Surgical microsurgical drills: Activation by ESUs [Hazard update]. Reusable active electrodes and accessories. 2 Inspection and Preventive Maintenance System ©1995 ECRI. 1991 Dec. ESU return electrode contact quality monitors [Evaluation]. 6:119-21.

do not use excessive lead lengths or coil the leads because either may affect measurement accuracy. AC Plug/Receptacles. 22:601-2. A number of methods for testing electrosurgical output have been suggested. check their condition. that assembly hardware is present and tight.1 Chassis/Housing. Birtcher 5000. check the security of this attachment. Hazardous high voltages are present inside electrosurgical units. 3 . examine the condition of the mount. Items 2. If the device moves on casters. and be sure that they turn and swivel. if the unit is so equipped. Use an electrosurgical unit analyzer with appropriate load resistances for measuring electrosurgical unit output. All Rights Reserved. Risk of electrosurgical burns at needle electrode sites [Hazard]. open the plug and inspect it. Do not contact either the active or dispersive electrode while the unit is activated (under some circumstances. Examine the AC power plug for damage. Electrosurgical units can be damaged by such operation. When measuring output (e.4 Inspection and Preventive Maintenance System ©1995 ECRI. When making connections and whenever testing is not being performed. Check the operation of brakes and swivel locks. However. Mount. as required. including the use of light-bulb loads. active electrode and/or return electrode. 1995 Jan. as appropriate. 1995 Jan. Qualitative tests 1. Electrosurgical units with accessory outputs [User Experience NetworkTM]. and check that it is held firmly. 1994 Jun. 24:6-27. carefully read this procedure and the manufacturer’s instruction and service manuals. 1. Be sure that all connections are secure and well insulated before performing any power output test. insert an AC plug into each. especially at maximum control settings. Be sure that plastic housings are intact. If the device has electrical receptacles for accessories. Procedure Before beginning an inspection. If Special precautions Electrosurgical units deliver high voltage and high power that can cause serious electrical burns. make sure the unit is off or in the standby mode. Do not open the electrosurgical units for inspection or adjustment unless you are qualified to do so. be sure that you understand how to operate the equipment. 1993 Dec. Attempt to wiggle the blades to determine that they are secure. and some methods may damage the electrosurgical unit.2 1. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. open-circuited dispersive electrode connector may be required Electrosurgical unit analyzer Oscilloscope and high-voltage probe (acceptance testing only) 1. Misconnection of bipolar electrosurgical electrodes [Hazard].. 24:34-5.3 and 2. burns can occur even from contact with the dispersive electrode). Examine the exterior of the unit for cleanliness and general physical condition. If it is attached to a wall or rests on a shelf. adapters. Never operate any electrosurgical unit for prolonged periods during testing. none of these provide quantitative performance data. 1994 Aug-Sep. 23:373-4. 23:257-9. If any damage is suspected. and that there are no signs of spilled liquids or other serious abuse. Shake the plug and listen for rattles that could indicate loose screws. Monopolar electrosurgical safety during laparoscopy [Guidance article]. Look for accumulations of lint and thread around the casters.3 1. Fatal gas embolism caused by overpressurization during laparoscopic use of argon enhanced coagulation [Hazard]. since this may damage the unit. Casters/Brakes. Test apparatus and supplies Leakage current meter or electrical safety analyzer Ground resistance ohmmeter High-resistance (20 MΩ) ohmmeter Connectors.g. and Valleylab Force electrosurgical units [Hazard]. the significance of each control and indicator. Never activate the unit with the active and dispersive electrodes connected together (short-circuited). If the device is mounted on a stand or cart. sparking the active electrode to the return electrode.Electrosurgical Units Use of an incompatible footswitch with Aspen Excalibur. 1993 Dec. and cutting a slice of beef placed on the return electrode. and the alarm capabilities. 22:593-4.10).

) 1.g. connect a complete cable and dispersive electrode assembly to the electrosurgical unit.1 or 3. from fingernails.12 Filters.. If the device has a switch-type circuit breaker. If the alarm activates. cut out the defective portion. meters. 1. Examine the strain reliefs at both ends of the line cord. consider a full inspection of the receptacle. inspection. check its value and type against that marked on the chassis. check for proper alignment. Before moving any controls. If the device is protected by an external fuse. Be sure that they hold the cord securely. During the course of the inspection.20 Dispersive Cable Continuity Monitor. gauges. . suspect a weak connector. and bright. or.18 Indicators/Displays. replace them with single-use dispersive electrodes with preattached adhesive. and visual displays on the unit.g. replace the entire cord. Clean or replace if needed. If this does not occur. disconnect any active electrodes. The electrosurgical unit should be locked out of activation in this alarm mode. If this cable motion sets off the alarm.13 Controls/Switches. Using disposable dispersive electrodes with preattached adhesive is much less likely to result in patient burns. To test the cable continuity monitor.. and correct motion. if the damage is near one end. it is defective and needs repair. Check membrane switches for membrane damage (e. which may annoy the OR staff. Unplug or unscrew the cable connector from the dispersive electrode. 1.11 Dispersive Electrodes. pens). and turn the unit on but do not operate it. Confirm that their strain reliefs are secure.g. Inspect reusable dispersive electrode cables carefully for any breaks in the insulation and other obvious damage. If damaged. turn all output controls to minimum. the return cable may be shorted or the alarm itself may be defective.7 1.9 1. All Rights Reserved.4 of the inspection form. indicators. 1. unplug the dispersive electrode cord from the electrosurgical unit. Where a control should operate against fixed-limit stops. Record the settings of those controls that should be returned to their original positions following the 4 Inspection and Preventive Maintenance System ©1995 ECRI. Examine the electrosurgical unit and return electrode connectors for signs of damage. 1. Examine electrical connectors for general condition. During the course of the inspection. If the dispersive electrode is permanently attached to the dispersive cable and the electrosurgical unit is designed to automatically disable the buzzer alarm when the dispersive cable is 1. Inspect the cables (e. clean.5 Line Cord. Check the condition of all filters. (If reusable dispersive electrodes are in use. The unit should alarm immediately and should resist activation. be sure to check that each control and switch performs its proper function. footswitch) and their strain reliefs for general condition. Examine all controls and switches for physical condition. Suspend the dispersive electrode in the air so that it does not touch any metal surface or object that might provide a ground pathway back to the electrosurgical unit. secure mounting. a visual) alarm if continuity of the return cable is interrupted. The alarm should not sound. Inspect the cord for signs of damage.6 1.. To determine the cause. Cables. Circuit Breaker/Fuse. Be sure to wire a new power cord or plug with the same polarity as the old one. and ensure that a spare is provided. confirm the operation of all lights. check that it moves freely. Electrical contact pins or surfaces should be straight. 1. consider the possibility of inappropriate clinical use or of incipient device failure.10 Fittings/Connectors. If the alarm does not activate. check their positions. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors at each end to prevent rotation or other strain. Be sure that all segments of a digital display function. and arrange for repairs. Do not touch the electrode. and indicate this on Line 3. as well as positive stopping. a control set at maximum output). Confirm that this sentry triggers an audible (and on some units.Inspection and Preventive Maintenance System accessories are plugged and unplugged often. the dispersive cable is defective and should be replaced. A loose panel connection to the dispersive cable often causes the return cable continuity monitor’s alarm to sound. Wiggle the dispersive cable connection at the unit. Strain Reliefs. Check that several dispersive electrodes and dispersive electrode cables (separate or preattached) are stored with the electrosurgical unit. If any of them appear inordinate (e.

An initial low resistance that drifts up to a value over 20 MΩ is acceptable. This measurement should indicate an open circuit (exceeding 20 MΩ or largest reading of the ohmmeter) for isolated-output units or grounded units equipped with a capacitor between the dispersive electrode and ground. Examine the footswitch for general condition. activate the unit in its various operating modes. ECRI recommends that units with the dispersive electrode connected directly to ground be replaced with isolatedoutput or ground-referenced units. We recommend a maximum of 0. turn all the unit’s power controls to zero.21 Audible Signals.. Any significant reading on the leakage current meter indicates that the meter is susceptible to high-frequency interference and cannot be used when the electrosurgical unit is activated.. Connect a return electrode if the unit cannot be activated without one. 2. Connect one lead of the leakage current meter to ground. the latter are called ground-referenced units. 1.15 Ω) for grounded-output units without a capacitor. There should be a short circuit (approximately 0.g. Activate the switch in both the Cut and Coagulation modes and flex the cable at the entry to the switch to check for internal wire breaks that may cause intermittent device operation. this phenomenon is due to a charging capacitor. Check for any tendency of the footswitch to stick in the On position. and position the meter away from the electrosurgical unit. 5 .22 Labeling. Test alternative protective features according to instructions from the manufacturer’s literature. Units with audible activation indicators that can be set to inaudible levels should also be removed from service or modified by the manufacturer so that the alarm cannot be set to an inaudible level. Inspection and Preventive Maintenance System ©1995 ECRI. If volume controls have been set too low. as well as the operation of a volume control. Before measuring the leakage currents.. ground pins.23 Accessories. Footswitch.1 Grounding Resistance. These include features intended to monitor the integrity of the patient circuit (e. Dispersive electrode grounding resistance. dispersive cable continuity monitor). A value less than 20 MΩ for ground-referenced units suggests a defective capacitor between the dispersive electrode and ground inside the electrosurgical unit. An adapter cord will be needed if the unit is equipped with a specialized operating room plug.Electrosurgical Units unplugged. Confirm appropriate volume.5 Ω. Serious injury has been associated with warning signals (e. A 0.g. Operate the device to activate any audible signals (e.2 Chassis Leakage Current. Check that all necessary placards. Units that lack audible activation indicators should be removed from service. Quantitative tests 2. Measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis.g. power line frequency and leakage current measurements must be made with the unit connected to a grounded (conventional) power supply to obtain valid readings. discuss this problem with users so that clinical practices can be corrected.. including evidence of spilled fluids. These features can be either integral to the electrosurgical unit or add-on devices.24 Special Protective Features. dispersive electrode contact quality monitors). labels. With the other lead of the leakage current meter in the vicinity of the electrosurgical unit but not in contact. Measure the resistance between the dispersive electrode and the ground pin of the power cord. activation indicator) whose volume controls had been set so that the signals were not audible.. keeping the output at the minimum settings. accessory outlet. 1.g. use an open-circuited connector to test the alarm. or minimize injury from active electrode insulation failures or capacitive coupling (e. activation indicator.g. monopolar electrode shielding devices). ensure absence of inadvertent ground contacts (e. and footswitch. All Rights Reserved. and instruction cards are present and legible. CAUTION: Never measure 60 Hz leakage currents from the active electrode while the unit is 2. While electrosurgical units are generally operated from isolated power systems in the operating room. return fault monitors). 1. 1. This is most readily accomplished by removing the electrosurgical unit from the operating suite to an area with grounded power distribution.1-microfarad capacitor connected across the leakage current meter terminals may reduce this interference and will not unduly affect the line frequency leakage current readings.

Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. The dispersive cable and dispersive electrode of the electrosurgical unit must not be in contact with ground. if needed.. If the unit has no dispersive circuit monitor. . Also. Consult the unit’s manual if you are uncertain whether it is an isolated output device. Using all the operating modes available on the electrosurgical unit. Leakage currents from the chassis should not exceed 300 µA. This test is intended for isolated output units to determine whether the isolation has been degraded. since this places an unrealistic and unnecessary strain on both the electrosurgical unit and the tester. If the unit has a dispersive sentry. when testing an isolated output electrosurgical or = 1 – Current2 (amps) of isolation test (Item 2. With the unit in the Pure Cut or Cut 1 mode. If the tester has an Isolation Test mode. when testing an isolated output electrosurgical unit.10) x 100% Isolation should meet the manufacturer’s specifications or be ≥80%. but output powers may be different from those given in the service manual (some manuals may indicate how output varies with load resistance). connect the output current/power meter between the active cable and a ground (e. 3. since this will stress the unit. All Rights Reserved. it can still be used. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.g. experienced personnel. Measure with the unit off. suspend the dispersive electrode in the air by hanging the dispersive cable over a hook. Erratic output power in spark-gap units suggests that spark gaps may need maintenance or adjustment. is an indication of the degree of isolation. CAUTION: To avoid the possibility of burns.10) ate the unit for long periods or at maximum control settings.3 Output Isolation. on (standby). do not measure currents from the return electrode when the unit is activated. Test the unit at the manufacturer’s recommended output settings or at a typical clinical setting (or at a dial setting about one-third of maximum and at maximum). Cut 2) with power controls set at minimum. 2. Cut 1. Replace the filter. The output should increase smoothly from zero or nearly zero to maximum. As before.3) x 100% Output power (W ) at the sam e setting (Item 2. CAUTION: Never measure 60 Hz leakage currents from the active electrode while the unit is activated. do not touch the electrode. Compare output power to the manufacturer’s specifications. Do not perform this test on units with directly grounded dispersive electrodes or with dispersive electrodes connected to ground through a capacitor. unplug the dispersive cable from the unit. Otherwise. use a dispersive electrode or an appropriately wired adapter. Isolation % = 1 – P ower (W ) of isolation test (Item 2.g. follow the tester’s instructions. Also measure output at bipolar terminals. Output power should be tested according to the manufacturer’s recommendations. Also.Inspection and Preventive Maintenance System activated. Connect the output current or power meter to the active and dispersive connections on the electrosurgical unit. 4. Record the load resistance of the output meter on the inspection form. do not oper- 6 Inspection and Preventive Maintenance System ©1995 ECRI. and activated in each mode (e.1 3. If the electrosurgical analyzer in use does not have the load resistance suggested by the manufacturer. increase the controls gradually to one of the moderate levels used in the output power test and record the power to ground. This should be done only by qualified. On units with a return electrode continuity monitor. the chassis of the unit). Record the value for the mode that yields the highest leakage current.10 Output Current/Power. The isolation test is normally conducted after the output power measurement (Item 2.10). It will not be possible to read low-current values precisely.3) Output current2 (amps) of same setting (Item 2. Do not operate the unit at high control settings for prolonged periods. Use Lines 2. These measurements can expose you to high voltage and can damage the leakage current meter. Confirm that power is delivered to secondary monopolar terminals. record the output current or power from the meter. compared with the output recorded in Item 2. 2.4 Clean the exterior and interior.11 and 2. The extent of output reduction..10. Preventive maintenance 3.12 of the inspection form as needed for additional output power measurements.

In addition to the test described in Item 2. If a manufacturer has provided output waveform characteristics (e. do not measure currents from the return electrode when the unit is activated. frequency. This will ensure that excessive power is not available from the dispersive electrode. Leakage current from the active and return electrode should not exceed 50 µA. This test is optional. maximum output. In addition. Set the unit to Pure Cut. perform the following tests. All Rights Reserved.3. Before returning to use Ensure that the volume of audible activation indicators can be clearly heard.. waveform on-off time).1 Waveform Analysis. Power exceeding 5 W suggests a fault or design deficiency. These measurements can expose you to high voltage and can damage the leakage current meter. 4. and store all accessories. Inspection and Preventive Maintenance System ©1995 ECRI.2 Output Isolation (for isolated output units only).Electrosurgical Units unit. these may be studied and documented by using an oscilloscope connected to the appropriate jack on the output power/current meter. waveform repetition or burst rate. rotate the power control knobs to zero. 4. make a similar power measurement from dispersive electrode to ground. preferably with a handswitched active handle connected to the unit. neatly coil and store all cables. 7 . A high-voltage probe should be used for these measurements to prevent damage to the oscilloscope and to view the full waveforms. turn off the main power switch.g.

532 lasers. abrupt interruption of a surgical procedure. Failure of a frequency-doubled Nd:YAG surgical laser can cause patient or staff injury. many of the tests listed herein can be used or modified for these other lasers Risk Level: ECRI Recommended. green lasers.. The 532 nm light energy is preferentially absorbed by hemoglobin and is typically absorbed within 3 mm of the tissue surface. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. Nd:YAG lasers. does not apply to frequency-doubled Nd:YAG lasers used solely for ophthalmic surgery.Procedure/Checklist 464-0595 Frequency-Doubled Nd:YAG Surgical Lasers Used For: Lasers. gynecology. PA 19462-1298. Plymouth Meeting. The fiber may be used with additional devices (e. High. Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . . This minimizes the need for frequent additional periodic testing. however. gastroenterology. short procedure areas.g.) Energy exiting the crystal is typically directed into a flexible optical fiber that transmits the laser energy to the tissue. General-purpose frequency-doubled Nd:YAG surgical lasers direct the beam of an Nd:YAG laser through a crystal that halves the 1. bronchopulmonary. These lasers must be meticulously maintained to ensure proper and safe operation. endoscopy laboratories Scope: Applies to general-purpose frequency-doubled Nd:YAG surgical lasers that include contact and/or noncontact flexible fiberoptic delivery systems (either reusable or disposable). also does not apply to other ophthalmic lasers or to CO2 lasers. Frequency-doubled Nd:YAG surgical lasers affect tissue by delivering green visible light energy at a sufficient power density to cause vaporization and/or coagulation. The extent and frequency of inspection by hospital personnel should be coordinated with these outside services. emit visible green light energy at 532 nm. or damage to the laser system. hours hours Overview Frequency-doubled Nd:YAG surgical lasers are normally checked before each use by the laser’s power-on self-test and by user examination of the aiming beam and the delivery system to be used. Moving the fiber tip away from the tissue lowers the power density. through an endoscope) and/or with a laser handpiece or a laser 230376 464-0595 A NONPROFIT AGENCY 5200 Butler Pike..064 nm wavelength (i. applies to low. surgical lasers. (The Nd:YAG laser uses an yttrium-aluminum-garnet [YAG] crystalline rod that is doped with neodymium [Nd]. Frequency-doubled Nd:YAG surgical laser fibers are most often used in contact with or close to tissue to cause coagulation or vaporization. Surgical. causing less tissue to be vaporized or coagulated. doubles the frequency) to 532 nm. and ENT surgery procedures. and can provide sufficient power output to coagulate and vaporize tissue. argon lasers. or other surgical lasers. Manufacturers or outside service vendors often maintain lasers for hospitals. Hospital Assessment. Frequency-Doubled [17-729] Also Called: KTP lasers.org . Nd:YAG.e. endoscopic lasers Commonly Used In: Operating rooms.and high-power frequency-doubled Nd:YAG surgical lasers that are typically used for general surgery. neurosurgery.

Area security and use of personnel protective devices and practices should be consistent with hospitalwide laser safety procedures and/or should be approved by the laser safety committee. As a result. or standing). articulating arms on CO2 lasers). windows should be covered with nonreflective material to prevent transmission of laser energy to other areas. to summon help in case of an accident. these two beams are coincident as they exit the fiber. . frequency-doubled Nd:YAG lasers can emit a train of pulses or a single pulse. Test apparatus and supplies Leakage current meter or electrical safety analyzer Ground resistance ohmmeter New. 1991 Jul-Aug.g. All Rights Reserved.e. of sufficient optical density to protect the wearer’s eyes from laser energy Vise with padded jaws or ring stand with padded clamp Pressure gauges and coolant system tee fitting Outlet test fixture (optional) Insulating gloves.. and far greater care is required than with most devices. With frequency-doubled Nd:YAG surgical lasers. 1992 Sep. requiring a cooling system. or firebrick Laser radiometer (power meter) Laser safety signs Laser safety eyewear specifically designed for use with frequency-doubled Nd:YAG surgical lasers and 2 Inspection and Preventive Maintenance System ©1995 ECRI. 20(78):239-316. even a full room length or more away from the laser (and can harm tissue or burn material even at this distance). Do not perform these procedures when a patient is present or clinical staff is working. particularly when the internal interlock is overridden or in any other situation in which the energy does not diverge significantly over long distances. the beam may not diverge significantly. Most frequency-doubled Nd:YAG lasers use water/air cooling systems that are self-contained.. Therefore. at minimum. any significant problem with the therapeutic beam pattern introduced by an accessory would be apparent by examining the visible aiming beam. Wear appropriate laser safety eyewear at all times whenever the laser is in the Operating mode. 1″ or more wide. excess heat is generated in the laser cavity and doubling crystal. Laser energy can cause serious injury. In addition.. These attachments can focus the energy into a small spot size at a known working distance and/or a specific beam direction to accomplish special tasks. In a well-aligned system. unused fiber delivery system Black Delrin block 1⁄2″ or more thick. about 3″ to 4″ long.g. Citations from Health Devices Laser use and safety [Guidance article]. or connected to a water supply and drain. exercise great care whenever a laser beam is accessible. WARNING: Do not stare directly into the aiming system beam or the therapeutic laser. it is not necessary to periodically verify coincidence of the aiming and therapeutic beam or to assess the therapeutic beam pattern (e. Furthermore. connected to a freestanding chiller system. frequency-doubled Nd:YAG lasers are inefficient in converting electrical energy into laser energy. even when wearing laser safety eyewear. Misalignment of the beam at the fiber entrance would result in decreased power output or loss or distortion of the aiming beam. 21(9):306-10. Since the therapeutic and aiming laser beams are transmitted through a single optical fiber. Any beam pattern distortion at the fiber entrance would be eliminated as the laser beams travel through the fiber because of internal reflections within the fiber. Avoid placing the laser beam path at eye level (i. Personnel who inspect or service lasers should receive special training from the manufacturer or from a qualified alternative training source. TEM00) within the beam or spot. unlike those lasers that use mirror delivery systems (e. In addition. A second person should be present. and do not aim the laser across a path that a person might normally use as a thoroughfare. Under some circumstances. Surgical lasers [Evaluation]. Like most lasers. sitting. high voltage (optional) Grounding strap (optional) Calibrated flowmeter Special precautions Inspecting and maintaining lasers is a dangerous as well as necessary process.Inspection and Preventive Maintenance System micromanipulator (used to interface the laser with the surgical microscope). when kneeling. post doors to the room with appropriate laser safety signs stating that the laser is in use and that it is unsafe to enter the room without authorization by the service person performing the procedure. especially during procedures of recognized risk. tongue depressors.

carefully read this procedure and the manufacturer’s operator instructions and service manual. Verify that the key has not been left in the laser. Shake the plug. and that there are no obvious signs of water or oil leakage. it should be in the Standby/Disabled mode. Remove from the working area or cover with flame-resistant opaque material all reflective surfaces likely to be contacted by the laser beam. Ensure that equipment intended to be used to measure. If the procedure must be interrupted. use a redundant ground strap if you must enter the laser cabinet. drain. which can be lethal. use a firebrick or other nonflammable material behind the target material (e. check mounts or holders for other devices (e.g. 1. external power meters. Examine the AC power plug for damage.) Examine the exterior of the unit for cleanliness and general physical condition. Also. Similarly.. If the device is mounted on a stand or a cart.. because of the serious risk of explosion and fire.4 Inspection and Preventive Maintenance System ©1995 ECRI. determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. that assembly hardware is present and tight.. 1.Frequency-Doubled Nd:YAG Surgical Lasers The laser should remain in the Off position when not in use. Consult the manufacturer’s recommended procedures for servicing high-voltage laser circuits. perform tests with the unit turned off. 1. preferably. and listen for rattles that could indicate loose screws. 20 kV). use short durations when practical. Check the operation of brakes and swivel locks. perform the Grounding Resistance test (Item 2.. disconnect the laser from line voltage. (Remove it if it has been. If manual shutters for the aiming system or the therapeutic laser are accessible. Do not switch it to the Operating mode until the procedure is about to begin and the laser and its delivery system are properly positioned. Do not use the laser in the presence of flammable anesthetics or other volatile substances or materials (e.2 Mounts/Holders.g. that there are no signs of spilled liquids or other evidence of abuse. Check that the mounts securely contain any gas cylinders that may be in use. and use insulated gloves for those procedures in which contact with a high-voltage source is possible (and the gloves are not otherwise contraindicated). disconnect the laser from line voltage before entering the laser cabinet. and inform users of the importance of storing the key in a controlled location. Some surgical lasers use high voltages (e.g. or insulate high voltages carries the appropriate insulation rating (e. and being used. or in oxygen-enriched atmospheres. talc) on its inside surface because the agent could contaminate the gas recirculation system of the laser and ultimately contaminate a patient wound during a subsequent procedure. When in use. All Rights Reserved. starch. A CO2 fire extinguisher should be readily available. alcohol). Whenever possible. Be sure that all housings are intact and properly aligned.3 Casters/Brakes. Procedure Before beginning the inspection. that any retractable parts slide easily and lock in place if so constructed. Verify that the mounting apparatus is secure and that all hardware is firmly in place. and remove the laser operation key and store it in a controlled location. be sure that you understand how to operate the equipment. Wiggle the blades to determine whether they are secure. WARNING: Do not use an anesthesia or other similar bag that may have a mold-release agent (e. above 20 kV). footswitches). Report any laser accident immediately to the laser safety officer or equivalent. General. 3 . 1. Be sure to leave the shutter in the proper position for normal operation. AC Plug/Receptacle. When possible. Be sure that mounts or holders intended to secure the fiber to the fiber support (to protect the fiber when in use) are present. the significance of each control and indicator. Capacitors may store charges long after the device has been disconnected from line voltage. examine the condition of the mount. Verify that the casters roll and swivel freely.g. Target materials will ignite when exposed to high laser energies.g.. Shutters. ensure that they operate smoothly and correctly. Because of the presence of high voltage. black Delrin) when the laser is to be activated.1 Chassis/Housing. Qualitative tests 1. In such instances.1) before any other test that requires operation of the laser.g. a good ground must be present. and avoid contact with any portion of the high-voltage circuit until you are certain that the charge has been drained.. in good working order. as well as to the hospital risk manager. Where possible. and precautions needed to ensure safety and avoid equipment damage.

Examine all optical (e. operates smoothly. check and record their positions. secure mounting. replace if the pressure drop is >5 psi). verify the operation of both. including evidence of spilled liquids. If the device has a switch-type circuit breaker.. secure mounting. If a control has fixed-limit stops. Where a control should operate against fixed-limit stops. Footswitch.9 1. . Cables. Examine cables carefully to detect breaks in insulation and to ensure that they are gripped securely in the connectors at each end to prevent strain on the cable. surgical instruments). 1. as well as positive stopping. Some frequency-doubled Nd:YAG surgical lasers require deionized water. Clean or replace filters according to the manufacturer’s recommendations (e. check that it moves freely. kink. During the inspection. pens. and that they are secured adequately to any connectors. trail on the floor. Check that the internal switch is operating and that the footswitch does not stick in the on position. Ensure that a spare is provided or readily available. that they have not become cracked and do not show other signs of significant abuse. from fingernails. gas). If the device is protected by an external fuse(s).g. check its value and type against what is marked on the chassis or noted in the instruction or service manual. Electrical contacts should be straight. check for proper alignment. notify users to avoid using tape and sharp instruments. Examine the strain reliefs at both ends of the line cord. Examine the exterior of the control for cleanliness and general physical condition.12 Filters. replace the entire cord. If any position appears unusual. Some footswitches also include a switch to operate the liquid.8 1. Clean or replace air filters and radiators that are obviously dirty. Check the condition of all liquid and air filters. Liquid fittings should be tight and should not leak. Inspect all cables and their channels or strain reliefs for general physical condition. Check membrane switches for tape residue and for membrane damage (e. and electrical fittings and connectors for general physical condition. Remote.7 1. and bright. or be caught in moving parts. and that there are no signs of spilled liquids or other serious abuse. drain. 1.g. Examine all controls and switches for general physical condition.6 1. Examine all controls and switches for physical condition. Tubes/Hoses. There should be no visible dirt or residue in the optical path of the laser aperture. Before moving any controls. in this case. clean. and most require special filtration. if the damage is near one end. and intended range of settings. Be sure that housings are intact. General. If you find such evidence.g.Inspection and Preventive Maintenance System If damage is suspected. Footswitches for lasers include an internal switch that activates according to the depth of pedal depression.5 Line Cords. Check the condition of all coolingsystem hoses and any other hoses or tubing the laser may have (e. that they are connected correctly and positioned so that they will not leak.. and indicate this in the preventive maintenance section of the inspection form. If the remote control is attached by cable to the laser.or gas-cooling system. Be sure to wire a new power cord or plug with same polarity as the old one. All Rights Reserved. and correct motion.. Be sure that they grip the cord securely. Check that they are of the correct type. be sure to check that each control and switch performs properly.g. even through a shoe. correct motion. 1. fiber). Some footswitches include two internal switches. Circuit Breakers/Fuses. ensure that the cable and any connectors are in good condition..10 Fittings/Connectors. Examine the footswitch for general physical condition. be sure that each control and switch works properly. If a cord is damaged. or. that assembly hardware is present and tight. During the inspection. Measuring the pressure drop across a liquid filter can be helpful in determining whether the filter should be re- 4 Inspection and Preventive Maintenance System ©1995 ECRI. 1. consider the possibility of inappropriate use or of incipient device failure. and is in use.13 Controls/Switches. liquid. open the plug and inspect it. It is usually possible to feel the vibration caused by closure of the switch. placed. Ensure that any mechanism to close off the laser aperture (fiber port) is clean. check for proper alignment as well as positive stopping. Strain Reliefs. Inspect line cords for signs of damage. cut out the defective portion.

. using an ohmmeter.g. pulse or accumulated energy counter). A good-quality (e. If a door or window interlock is used. During the procedure. If no self-check feature is present. the function of the interlocks can be checked using an ohmmeter. check for internal wire breaks that cause intermittent operation. undamaged sheath) fiber or handpiece should be used for this test.19 Laser Delivery System Calibration. if present. Some frequency-doubled Nd:YAG surgical lasers include a user-accessible calibration port or power meter that allows output calibration and/or testing of the laser fiber. ensure that the water pressure is properly regulated and at the appropriate pressure and that the supply and drain system is properly configured (e. Refill or change the fluid according to the manufacturer’s recommendations.20 Alarms/Interlocks. ensure that it works. Based on the measurement from the calibration power meter. and verify that it is correct. 5 . 1. indicators. the laser may automatically recalibrate itself and/or adjust displays so that the power indicated to be delivered to the patient will be correct.g. fiber. be sure to test only those alarms that will not cause damage to the laser or present an unnecessary risk of laser beam exposure to yourself or bystanders. All Rights Reserved. check to be sure that the laser will restart. Flex the cable at the entry to the switch.g. Examine the male and female connectors for attaching the footswitch to the laser cabinet to be sure that no pins are bent and that no other damage is present.. (For some lasers.15 Motors/Pumps/Fans/Compressors. drain hoses are positioned in a sink or drain). verify that the same information (e. 1. and visual displays on the unit and remote control.17 Battery. gauges. >85% transmissibility.. 1. If a feature to manually reset this information is available. check to be sure that the laser activates consistently when the footswitch is depressed and that the fiber-coolant system operates properly when the fibercoolant switch is activated and deactivated. coolant) levels. Clean any obvious dust from these components. Confirm that strain reliefs are secure.. When it is necessary to replace a battery. 1. Ensure that user prompts occur in the proper sequence. Note any error messages displayed during the power-on self-test. 1. Operate the device in a manner that will activate the self-check feature.16 Fluid Levels. operate the laser in a manner that will activate each audible and visual alarm. Verify that this feature is functioning by using the manufacturer’s recommended calibration procedure to test one delivery system (e. or it may require the user to do this manually. During the inspection.g. if readily accessible. If display screens or digital displays are provided for user prompts or for viewing accumulated information (e. check or replace the battery (periodic prophylactic battery replacement is often preferred to risking battery failure during use). displays) is indicated on both control panels. filters are oriented for proper flow.g.18 Indicators/Displays. This feature is provided because transmission of laser energy through a fiber may change as a result of fiber use. handpiece) that the manufacturer indicates can be acceptably calibrated using these procedures.g. note this in the preventive maintenance section of the form.Frequency-Doubled Nd:YAG Surgical Lasers Check to be sure that this switch operates reliably.. Inspect the physical condition of batteries and battery connectors. Be sure to check the interlocks in all locations where the laser is used. If lubrication is required. and verify that all visual and audible alarms activate according to the manufacturer’s documentation. Store some sample information. Ensure that all segments of a digital display function. If primary and remote-control indicators and displays can be used at the same time or if control can be switched from one to the other during a procedure. (Do not disassemble major parts of the laser to test internal interlocks. ensure that it deactivates the laser properly. verify proper operation of all lights. ensure that each display provides the information expected. 1. Check the physical condition and proper operation of these components. meters. if present.) Inspection and Preventive Maintenance System ©1995 ECRI. If an external water supply is in use. and note this on the preventive maintenance section of the inspection form. and. label it with the date. settings.) After deactivating the laser and reclosing the door or window. If a remote control or display is battery powered.. Check all fluid (e. Ensure that the connector secures acceptably to the laser cabinet.

threads) are in proper working order. Ensure that the reflecting surfaces and lenses are intact and clean. ensure that it is firmly attached and properly oriented. Microscope micromanipulator. Operate the device to activate any audible signals (e. Be sure to check with the person responsible for scheduling the use of the laser before beginning the procedure. Be sure to handle it by the main body. Verify fiber performance. examine the connector. or snap-rings. Safety filters. Handpieces. and instruction cards noted during acceptance testing are present and legible. remove it from service. If a fiber is reusable. and verify that the signal can be heard in the environment in which the laser will be used. If a zoom focus feature is present. If a finger rest is present. handle lenses by the edges only. Verify that all necessary accessories are available and in good physical condition.. Examine the distal end of fibers to ensure that any connecting mechanisms (e. Carefully insert each lens into the micromanipulator. If a fiber appears to be dirty or damaged.21 Audible Signals. notify the person(s) responsible for fiber repair. Checking all fibers or accessories during a single inspection and preventive maintenance procedure is unnecessary as long as accessories are routinely checked by the person(s) responsible for laser setup and operation. Verify operation of safety filters in the microscope and endoscope delivery systems.Inspection and Preventive Maintenance System If the laser is equipped with an emergency “kill” switch. Check to see that an instruction manual is kept with the laser or is readily available. setting change). In addition. making the laser potentially unavailable. Consult the manufacturer’s recommendations for the procedures and cleaning agents to use to clean lenses.g. cable. Ensure that the connector properly seats into the laser aperture in the laser cabinet. Ensure that the mechanisms used to connect the handpiece(s) to the fiber are in good working order and that they reliably secure each handpiece to the fiber.g. are secure. Ensure that major subcomponents of the handpiece. for cleanliness and general physical condition. lenses) for cleanliness and general physical condition.) If lenses are detachable. (Do not remove other parts thatarepress-fitorattachedbyscrews. and tip of each fiber to be used. For the test fiber and before each use. Examine each objective lens to ensure that it is intact and clean. Check that all placards. be sure not to touch the lens surface. be sure that it turns easily and does not slip. Set up reusable accessories with the laser to ensure compatibility and proper functioning. test this feature to be sure that it deactivates the laser and that the laser will subsequently restart. Consult the manufacturer’s recommendations for the procedures and cleaning agents to use to clean reflecting surfaces and lenses. The fiber should be repaired and/or cleaned according to the manufacturer’s recommendations.23 Accessories. when assembled. and ensure that it fits snugly. many of the accessories are sterile and would require resterilization before use..bolts. Inspect the mechanism used to attach the micromanipulator to the microscope to ensure that all parts are present and that it is in good working order. do not hold it by the joystick.22 Labeling. laser emission. tips. as well as the fiber support. and do not touch the reflecting lenses in the body. Check for proper operation. 1. Examine individually only those components that are intended for removal during normal use and storage. 6 Inspection and Preventive Maintenance System ©1995 ECRI. Examine the microscope micromanipulator for cleanliness and general physical condition. Inspect micromanipulators provided by both the laser manufacturer and the laser accessory manufacturer. Consult the manufacturer’s recommendations for the procedures and cleaning agents to use to clean the objective lenses. labels.. Do not touch the lens surface.g. 1. 1. Examine the joystick to ensure that it is firmly attached and that it freely moves the reflecting lens. General. Examine each handpiece component (e. body. Fibers. All Rights Reserved. . Connect the micromanipulator to the microscope to check for a secure connection.

handpiece. ensure that appropriate grounding is present.. activate the unit. Verify that the beam turns off when the footswitch is released. except continuous.g. micromanipulator). and perform the manufacturer’s recommended user calibration procedure. with no halo. blast shield) behind the laser aperture. and maximum Repeat Pulse settings. and activate the laser at each setting. Be extremely careful to keep hands out of the laser beam path.) Inspection and Preventive Maintenance System ©1995 ECRI.. black Delrin or a tongue depressor). Compare the burns to verify that progressively larger burns occurred as the exposure duration increased. ground pins.1 Grounding Resistance. test the laser to be sure that the correct power is repeatedly delivered over the correct time period. which repeats the pulse at a fixed or adjustable rate. (Do not focus the beam to a small spot on the power meter. median.g. and footswitch.) Leakage Current.4 Repeat Pulse. Carefully move the target material to expose a 2. grounding is not required. 2. 2. in no case should it exceed 500 µA. Secure the delivery system at the appropriate distance from the detector of the laser power meter to meet spot-size requirements specified in the instructions for the meter. (If the footswitch is of low voltage. Remove and inspect the protective window (e. if the laser power meter does not measure pulse duration. and release the footswitch after about 1 sec. Use an ohmmeter. if adjustable. Select one delivery system (e. handpiece. Some laser power meters can react quickly enough to be used to test this feature of the laser. Some laser power meters can measure pulse duration. activate the laser and create a burn.10 Power Output.. If the unit includes a Repeat Pulse feature. accessory outlet. Adjust the exposure setting in increments of 0. or micromanipulator attached. If your laser power meter cannot be used for this test. Place and secure the laser fiber.5 Footswitch Exposure Control. Continue this process until you have tested all exposure settings. WARNING: Do not reverse power conductors for this or any other test.Frequency-Doubled Nd:YAG Surgical Lasers 1. and verify that it produces a round.1 sec or the next longest duration. WARNING: Make this inspection with the laser powered off. use the following less preferable alternative.g.5 Ω. Quantitative tests 2. or micromanipulator with the aiming system focused on the target material (e. the meter may be damaged. Set the laser to about 10 W and a 0. With the laser set to about 10 W and the exposure set at minimum duration. uniformly bright spot. use the following alternative test method. Where it is greater than 300 µA. and have developed a series of burns. Activate the aiming beam (without the therapeutic beam). All Rights Reserved.24 Aiming Beam.25 Laser Aperture.3 Exposure Duration. We recommend a maximum of 0. maintaining the same distance. Some power meters require that the unfocused or a defocused laser beam be projected into the power meter to cover the majority of the absorber surface. However. clean area. 7 . replace if needed. Frequency-doubled Nd:YAG surgical lasers typically use an attenuated therapeutic beam as the aiming beam. If the power meter can react to pulse duration (this is the preferred circumstance). 1. Improper attachment of conductors may damage the laser. If the laser beam is focused on the receiver of such meters. test the laser at each setting. fiber.2 2.1 sec exposure duration with the fiber. If you are using such a power meter. Set the output time for about 5 sec. If the number or duration between repeat pulses is adjustable. 2. 2. The leakage current on the chassis should not exceed 300 µA. or multimeter with good resolution of fractional ohms to measure and record the resistance between the grounding pin on the power cord and exposed (unpainted and not anodized) metal on the chassis. There should be no visible dirt or residue in the optical path of the laser aperture. and verify that the Repeat Pulse feature operates as expected by moving the target material slightly between each pulse. test that setting changes made throughout the range result in the expected performance. electrical safety analyzer. test this feature with the laser set at the minimum. measure the leakage current between the chassis and ground with the unit grounded and ungrounded. With the laser attached to a grounded powerdistribution system. It should be clean and undamaged.

nondiverging laser beam. threshold). 4. using techniques and cleaning solutions recommended by the manufacturer.g. activate the laser for a sufficient period to acquire acceptable readings.. and content of all labels. (Power meters use different time constants to acquire an acceptable reading.. Labeling. are functioning properly. With the laser set at low (e. specifically confirming that motors are operating in the proper direction... test it in a similar fashion with a power meter of appropriate resolution in the low-power range.g. Ensure that the branch circuits and the outlets for the laser are properly wired and rated for use with the laser. Ensure that the assembly is stable and that the unit will not tip over when pushed or when a caster is jammed on an obstacle (e. . proper phase rotation) has been installed. if necessary. polarity. exercise great care if the interlocks are to be defeated. Do not conduct electrical leakage current tests with reversed-polarity wiring. pump. 50% of full scale). at the last preventive maintenance procedure. If reverse-polarity leakage current measurements are made. or printer components as recommended by the manufacturer. Verify that progressive increases in pulse duration throughout its range of adjustment result in progressively larger burns.2 3. mW) feature. Casters/Mounts/Holders.2 3. 3. In addition. Because of the heightened risk associated with an unfocused. location. Preventive maintenance Verify that all daily preventive maintenance procedures recommended by the manufacturer are carried out. Replace filters as needed. Only appropriately trained personnel should attempt laser adjustments. 10% of full scale). Visit the area(s) in which the laser is to be used and ensure that laser signs.5 4. Calibrate/adjust any components (e. Lubricate any motor. If the device is designed to rest on a shelf. do not switch conductor connections or wiring configurations for any tests. Electrical Wiring Configuration. printer) according to the manufacturer’s recommendations. blast shield. ensure that it has nonslip legs or supports.3 3. turn off the unit being tested before switching 4. 4. proper neutral and ground connections. In addition. and you must know and meticulously follow them.1 Areas of Use. Also test the ability of the laser to deliver laser energy as expected in all configurations and with all provided laser accessories.g. if present. compressor. fan. If the laser includes a low-power (e.. medium (e. 4. as may occur during transport. Ensure that all hoses and tubes are tight. Examine the receptacles at each location where the laser is to be used to ensure that the proper electrical configuration (e. microscope lenses). (Consult National Electrical Manufacturers Association [NEMA] configurations for general-purpose nonlocking and locking connectors if in doubt. lasers powered by three-phase electrical systems may be damaged if proper electrical phase connections are not made initially and maintained thereafter.4 4.4 4. Thus.1 Clean the exterior.) Pulse Duration.3 3. Examine the unit and note the presence. and window coverings are available and being used and that safety interlocks for doors or windows. Connect the laser to each receptacle and confirm that the laser operates properly.Inspection and Preventive Maintenance System WARNING: Accessing the unfocused laser beam may require defeating internal interlocks.g. a line cord. eyewear. Verify that the plug is acceptable for use with the maximum current and voltage specifications for operating the laser. Acceptance Testing Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. All Rights Reserved.g.g. perform the following tests. the measured and displayed values should all be within 10% of one another. and maximum output.6 8 Inspection and Preventive Maintenance System ©1995 ECRI. Check all fluid levels and supplement or replace fluids as needed. including leakage current measurement. compare the reading obtained with the reading taken on incoming acceptance testing. Clean accessible optical components (e..) Compare the reading with the power display of the laser. Also.. WARNING: Lasers may be damaged by switching between normal and reverse polarity while the device is on.g. or after the last service procedure. AC Plug. Labeling information is typically found in the laser’s Operator Manual.

test this feature as described in Item 2. If the unit includes a Repeat Pulse feature. medium. but over the full range of available settings. and function before using the unit. 9 .7 Repeat Pulse. Power Range. Use the manufacturer’s recommended calibration procedure to test each new reusable delivery system (e. Before returning to use Be sure to return controls to their starting position and place a Caution tag in a prominent position so that the next user will be careful to verify control settings.g. Using the technique described in Item 2. and high settings.9 Delivery systems with less than the manufacturer-recommended transmission (typically >85%) should be returned to the manufacturer. you can calculate it using the following formula: % Transmission = Delivered power × 100% Power entering the fiber 4.Frequency-Doubled Nd:YAG Surgical Lasers 4. setup. handpiece) that the manufacturer indicates can be acceptably calibrated using these procedures. All Rights Reserved.8 4. Note the fiber transmission for each delivery system tested if this information is provided by the laser. Or. fiber. test the power output accuracy at several low. Inspection and Preventive Maintenance System ©1995 ECRI..10.4. Laser Delivery System Calibration.

stains. the inspection will reveal any deficiencies that may have been introduced by improper or inadequate maintenance. Plymouth Meeting. be sure that you understand how to operate the equipment. it also provides more detailed instructions for some tasks commonly encountered in other procedures. or cart. fasteners) is present and tight. . Test apparatus and supplies Leakage current meter or electrical safety analyzer Ground resistance ohmmeter with a resolution of about 0.2 095674 438-0595 A NONPROFIT AGENCY 5200 Butler Pike. carefully read this procedure and the manufacturer’s instruction and service manuals. it. Before beginning any inspection. along with general acceptance tests for all devices. examine the condition of the mount.Procedure/Checklist 438-0595 General Devices Commonly Used In: Patient and nonpatient areas Risk Level and Inspection intervals depend on device and circumstances Type Major Minor Interval months months Time Required .org .1 Ω to around 0. If the device is mounted on the wall or on a stand. Modify or add items if needed. for additional precautions and guidelines. dried patches). 1. and that there are no signs of spilled liquids (e. Other devices will require additional performance checks derived from manufacturer-supplied information and the clinical engineer’s or technician’s understanding of the device and its clinical application. Examine the exterior of the unit for cleanliness and general physical condition.5 Ω Hydrometer Special precautions If there is evidence of blood or body fluid contamination. To the extent possible. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. Qualitative tests 1. If a different order is more convenient. Also determine whether any special inspection or preventive maintenance procedures are recommended by the manufacturer.. hours hours Overview This procedure provides guidance for inspection of any device for which no specific procedure is applicable. that all assembly hardware (e. reconfirm the functioning and accuracy of the affected portions of the device following the repair. However. IV pole. feel free to adopt 1. Verify that the Procedure Do not feel constrained to follow the order of items in this or the device-specific procedures and checklists. Skip items that are not relevant to the device being inspected. submit the device for cleaning and decontamination before inspecting it. even if it entails doing part of one test early and the rest of it later. the significance of each control and indicator. Ensure that plastic housings are intact. behind the Guidance Tab of this binder. See the article on IPM Safety. Mount/Fasteners. physical damage. or other serious abuse. do not check the Pass or Fail column until the item has been completed. If the inspection indicates the need for maintenance. screws. and the alarm capabilities.g.g. It can be used as is for many simpler devices. PA 19462-1298. perform preventive maintenance tasks first.1 Chassis/Housing..

3 Casters/Brakes. taped sections). are generally conducted as part of a check of all furniture or devices within an area (see Conductive Furniture and Floors Procedure/Form 441).g. Ensure that the assembly is stable. Cracked or brittle O-rings should be replaced. Examine the AC power plug for damage. With the device plugged in. If keyed connectors are used (e. All Rights Reserved. check its current rating and type against that marked on the chassis.1 or 3. outlets on a resuscitation cart) or devices are plugged and unplugged frequently.. advise clinical personnel that a spare fuse is provided primarily to expedite a rapid return of the device to operation 1. check that it moves freely. ensure that no pins are missing and that the keying is correct. Carefully examine cables to detect breaks in the insulation and to ensure that they are securely gripped in the connectors at each end.. be sure to wire the new power cord or plug with the correct polarity.g.5 Line Cord. Examine all gas and liquid fittings and connectors. and probes are available. Before moving any controls and alarm limits.8 and that the clinical engineering (or other appropriate) department should be notified when a fuse blows so that it can investigate the cause and provide another spare fuse. Check the condition of all liquid and gas (air) filters. Be sure that they hold the cord securely. If the device is protected by an external fuse. Inspect all line cords. AC Plug/Receptacles. inspect them for damage and insert an AC plug into each to check that it is held firmly. 1. Cables. check their positions.9 1.4 of the inspection form. If the device has a switch-type circuit breaker. Verify that all electrodes. Inspect any cables (e. Attempt to wiggle the blades to determine if they are secure. If damage is suspected.g. consider the possibility of inappropriate clinical use or incipient device failure. Check that they are correctly connected and positioned so they will not kink. See Electrical Receptacles Procedure/Form 437 for more information. consider more extensive testing. those from another manufacturer) has caused patient injury and erroneous results. and bright. verify that there are no intermittent faults by flexing electrical cables near each end and looking for erratic operation or by using an ohmmeter. Check the operation of brakes and swivel locks.) Strain Reliefs. pin-indexed gas connectors).10 Fittings/Connectors.12 Filters. check their condition. if necessary. Check the condition of all tubing and hoses. Use a tension tester to measure the tension of each contact.13 Controls/Switches.11 Electrodes/Transducers.4 1. Tubes/Hoses. If the outlets are used for critical devices (e. which will prevent rotation or other strain. . If the spare fuse is missing. Clean or replace as appropriate. Check that the casters roll and swivel freely. Keying pins should be securely seated in “blind” holes so that they cannot be forced in farther. If the device has electrical accessory outlets. 1. clean. be caught by moving parts. Examine the strain reliefs at both ends of the line cord. Check for weld cracks. electrode.g. 1.Inspection and Preventive Maintenance System mounting apparatus is secure and that all hardware is firmly in place. open the plug and inspect it. for general condition. Examine the physical condition of reusable units. If any of them appear inordinate (e. 1.7 2 Inspection and Preventive Maintenance System ©1995 ECRI. If the device moves on casters.g. 1. remote control) and their strain reliefs for general condition. sensor. Gas and liquid fittings should be tight and should not leak. Shake nonmolded plugs and listen for rattles that could indicate loose screws. or be damaged during operation.g. Record the settings of those controls that should be 1.. and indicate this on Line 3. the use of incorrect probes (e.6 1. Where appropriate. use an outlet test fixture to verify that the accessory outlet is energized and correctly wired. for signs of damage or inappropriate repairs (e. If there is a spare fuse holder. including the battery charger line cord. transducers.. verify that a fuse of the same rating and type is provided. If replacement is necessary. interfere with the operator.. Check that appropriate transducers and probes are being used.. Conductivity checks. as well as all electrical cable connectors. (Reversed hot and neutral wiring may pose a hazard to service personnel since the on/off switch may not open the hot line in the off position. Circuit Breaker/Fuse. alarm limits at the ends of their range). Electrical contacts should be straight. including spares and optional units and — especially for emergency and resuscitation devices — an adequate supply of disposables. a gain control at maximum. 1.

To the extent possible.22 Labeling.2 of the form. in fact.20 Alarms/Interlocks. Check the condition of the battery charger. Check alarm parameters that may be set on hidden menus (see Item 1. and easy to understand. Operate the device to activate any audible signals (e. and default values..15 Motor/Pump/Fan/Compressor. operate the heater to verify that its controls function properly (e. A copy of the instruction manual should be readily available to the user. pens). do not check the line until all lubrication is completed. Lubricate if required.) Activate self-test or service-mode functions that allow simple performance verification. Audible alarm-volume controls should not allow the alarm to be turned off or lowered to an indiscernible volume. meters. 60 Hz interference). or measure the output voltage with the unit on to assess battery capacity. (Where a quantitative check is required. ensure that each control and switch performs its proper function. 1.. legible. control heater power). We are not aware of significant leakage problems with most other battery types. and correct motion. 1.. If the device has an alarm-silence feature. Look for any signs of improper or excessive wear. gears. volume. All Rights Reserved. gauges. Check that all necessary placards. Operate the unit on battery power for several minutes to verify that the battery is charged and can hold a charge. Check all fluid levels. 1. and note any problems (e. 3 . If inspections repeatedly reveal that alarms have been turned off or silenced or that the volume has been adjusted too low. When it is necessary to replace a battery. Inspection and Preventive Maintenance System ©1995 ECRI. indicators. poor focus. and verify that battery charge indicators function. verify the operation of any lights. and visual displays on the unit and charger. Ensure that all segments of a digital display function. (However. label it with the date. distinctive.g. Check parameters that may be set on “hidden” user or service menus. belts. including those in lead-acid batteries. and user in-service training is required. inappropriate use is indicated. check the method of reset (i. If a control has fixed-limit stops. 1. 1. including special modes and alarm on/off..g. Check mechanical alignment and proper adjustment of any pulleys.17 Battery/Charger. an infusion pump initiates KVO rate upon alarm). from fingernails.g. etc. Check that control knobs have not slipped on their shafts. and verify that the signal can be easily heard in the area in which the device will be used.g. Examine the heater for damage (e. Observe a signal on a waveform display. If a remote alarm-indicator is required. Check membrane switches for membrane damage (e.g. 1. QRS beeper).16 Fluid Levels. 1.23 Accessories. Activate the battery test function (if so equipped). and instruction cards are present. deteriorated insulation). Examine all controls and switches for physical condition. Verify that the calibration function operates. Inspect the physical condition of all batteries and battery connectors if readily accessible. verify that it is available and functioning.21 Audible Signals. Check for proper operation of the volume control. Check the physical condition and proper operation of these components.14 Heater. Check operation of battery-maintained memory and battery-operated power-loss alarms. as well as positive stopping. conversion charts. 1. check for proper alignment. (The inspection can be carried out on battery power to help confirm adequate battery capacity. that a variable temperature control does.. add it to the quantitative section.g.. 1. Verify that all necessary accessories are available and in good condition. if so equipped. corrosion of its sheath. distortion.e. Disposable carbon zinc batteries may leak and must be inspected. Verify that alarms are loud. Check that all associated interlocks or features function (e. manual or automatic) against the manufacturer’s specifications. such as metal filings.General Devices returned to their original positions following the inspection. During the course of the inspection. Induce alarm conditions to activate audible and visual alarms.) Measure the specific gravity of lead-acid batteries.19 Calibration/Self-Test. labels.13).. and note this on Line 3. chains.) 1.18 Indicators/Displays. During the course of the inspection. secure mounting. and/or bright enough to be noticed in the environment in which the device will normally be used.

1 Ground Resistance. The instrument is not usually grounded. the following electrical safety tests are common to all line-powered devices. look for the cause of the increase (e.g. clinical laboratory). Some double-insulated devices may have a three-prong plug.2 Chassis Leakage Current. electrical safety analyzer. The measurements should be made with all accessories that are normally powered from the same line cord connected and turned on. If the unit has heating and cooling modes. and handles that are unlikely to be exposed to current-carrying components of the device need not be grounded. Verify that all modules or cable-connected parts of a system are grounded. Metal trim... All Rights Reserved. and off. a loose or corroded connection). recommended intervals. nurses’ station. or multimeter with good resolution of fractional ohms.. To avoid damage. but the grounding prong may be unconnected. Interference from stray radio-frequency (RF) fields or currents produced by some high-frequency devices (e. Assuming that the device has met incoming inspection requirements. and additional discussion of electrical safety testing requirements. Some devices are powered (or recharged) by an AC adapter that plugs into a wall outlet and carries a low voltage to the instrument by a connecting cord. remember that some devices. it should not exceed 300 µA for equipment used in patient care areas or 500 µA for devices in nonpatient care locations (e. grounding is not required. Since poor test lead contact can increase ground resistance measurements. With the polarity of the power line normal and the equipment ground wire disconnected. check its grounding to the main power cord. this poses no safety risk. Quantitative tests Most quantitative tests are device specific. set the thermostats so that each operates while readings are taken. an increase in grounding resistance from one inspection to another may indicate a loosening connection. If testing in the reversed-polarity mode. Also check that the ohmmeter reads zero when the leads are shorted together. Leakage current must be measured with the device powered by a conventional (grounded) power system. If the device has an accessory outlet. In the event of interference. measure and record the resistance between the grounding pin of the power cord and exposed metal on the chassis. turn off the unit until the motor stops or for at least 10 sec before switching polarity. diathermy units) may cause erroneous leakage current readings. (Refer to the article on Electrical Safety. ensure that both test leads are in firm contact with a portion of the ground prong or chassis that is clean and shiny (e.5 Ω is acceptable. However. or compressor. ungrounded mode. electrosurgical units. nameplates. During routine inspections. Open the unit or plug.g. If the device has a special plug (e.g. Appropriate tests are listed in the individual procedures or should be derived from device specifications and an understanding of the device’s clinical application and design. especially those incorporating a microprocessor. 2. Conductive portions of the chassis or housing that may become energized must be grounded. behind the Guidance Tab of this binder.Inspection and Preventive Maintenance System 2. This applies to devices that are plugged into accessory outlets on the device and to devices that are plugged into a multiple-outlet strip (“Waber strip”) so that the devices are grounded through a single line or extension cord. including on. motor. ECRI believes that either design is satisfactory. Although a stable grounding resistance as high as 0. Using an ohmmeter. Record the maximum leakage current. Do not measure grounding resistance of double-insulated devices unless designed to be grounded. measure chassis leakage current with the device operating in all normal modes. try a different leakage 4 Inspection and Preventive Maintenance System ©1995 ECRI. standby. it is necessary to test leakage current only in the correct-polarity. and repair it. Routine lead leakage current measurements are also not required. . for the rationale.. Two signs of such interference are readings obtained with the leakage current probe held near (but not contacting) the device and needle deflection that does not change accordingly as the meter scales are changed. may be damaged by switching polarity while the device is on. explosion proof). even if it is normally used in an area with isolated power. just indicate “DI” on the inspection form. a corresponding adapter is required.. Double-insulated devices may or may not be grounded.g. unpainted and not anodized).) 2.g.

place a small capacitor (0. Add the following supplemental items to the qualitative and quantitative tests that would be conducted during a major inspection.1 µf) across the leakage current meter input terminals. Ensure the proper operation of mechanical brakes and interlocks.. Inspect/clean interior. cracked. Preventive maintenance Most preventive maintenance tasks are device specific. gas. Refer to the Preventive Maintenance and Cleaning article.. or multimeter with appropriate resolution. Chassis leakage current of permanently wired equipment cannot be readily measured after installation is completed. Clean as necessary. Clean filters as appropriate (most filters are disposable and should be replaced as needed). Acceptance tests Upon initial receipt of a device or following repair. however. the grounding pin of an electrical receptacle or some other known ground) and exposed (i. that have friction points.1 Clean. excessive lubrication. behind the Guidance Tab of this binder. inspect the interior of the unit and look for accumulations of dirt. Electrical components. Though confirmation of grounding integrity provides reasonable assurance of safety. However. 3. units with ventilation fans without air filters. dust. Replace liquid. 3. Lubricate mechanical components such as motors. NFPA 99 calls for voltage measurements for installed devices in the patient vicinity.3 3. etc. 5 . make a thorough visual inspection. and 40 mV is acceptable in critical care areas. Appropriate tasks are called out in the individual procedures or should be derived from device specifications and an understanding of the device’s clinical application and design. Flush fluid lines and reservoirs as necessary. (Alternative) Ground Voltage (For Installed Equipment). motor brushes. or dry-rotted tubing. Cleaning the exterior of the equipment is normally the responsibility of the user.4 Replace. Mechanical components. Excessive or inappropriate lubrication can cause damage. spilled fluids. Inspection and Preventive Maintenance System ©1995 ECRI. for guidelines on the selection of cleaning solvents and appropriate techniques.g. A voltage reading of 500 mV is acceptable for general care areas. a periodic extra effort may be required to maintain the appearance and prevent operational problems. latches. In addition. and ventilation (air) filters. conduct appropriate specific tests as indicated in the individual inspection procedures and as required to verify purchase order and manufacturer specifications. Calibrate/Adjust. wheels. hinges. a bedside monitor grounded through the line cord and its central station connection). Perform calibration and adjustments as recommended by the manufacturer or indicated by inspection results. and tighten as necessary. and indicators. Inspect for loose and worn components. or measure leakage currents with the RF generator off. 3. switches. Using a voltmeter.General Devices current meter.. Align and tighten external control knobs. chains. Thus. 4. 2. Exterior and accessories. Opening the housing for internal cleaning is unnecessary and not recommended for many devices. behind the Guidance Tab of this binder. behind the Guidance Tab of this binder. some users grow complacent or accustomed to the appearance of the equipment. measure and record the voltage between a reference grounding point (e.. refer to the manufacturer’s literature for lubrication requirements. Refer to the Preventive Maintenance and Cleaning article. unpainted and not anodized) metal on the chassis.g. NFPA 99 calls for measurement of chassis leakage current with the redundant ground intact. missing spare fuses.e. for additional information on lubrication. Though confirmation of grounding integrity provides reasonable assurance of safety for devices with permanent redundant grounding (e. some units with high DC voltages). Where appropriate (e. units with evidence of spilled fluids that may have entered the unit. 3. and signs of mechanical wear. All Rights Reserved. Verify the integrity and proper operation of all mechanical components and hardware.2 Lubricate. Orings. deteriorating. bearings.g.2. foreign objects. and other components as needed or at intervals recommended by the manufacturer. electrical safety analyzer. the following items should be considered and incorporated as appropriate. for guidelines on the appropriate cleaning solvents and techniques. Refer to the article on Preventive Maintenance and Cleaning.

Attaching the unit to wallboard (e. correct swivel). and used by clinical personnel and where it will not be bumped or hinder access to the patient for routine or emergency care. and cables away from the unit and place the unit so that patients. particularly for high-risk devices.g. see Health Devices 1993 May-Jun. A. SJT.1.g. report any damage to the manufacturer. consider attaching a fuse clip and spare fuse.4 AC Plug/Receptacles. may be left on a device that is plugged and unplugged infrequently. discuss corrective action with the manufacturer.) The cord should be of suitable quality and current-carrying capacity. A. Ensure that the line cord is long enough for the unit’s intended application. .7 cm] diameter casters for mobile devices to reduce shock to the unit and to minimize the effort required to roll the unit across elevator thresholds and other uneven surfaces.g. as may occur during transport. Check for shipping damage. (A length of 10 ft [3 m] is suitable for most applications. ST. shipper. 120 V).3 Casters/Brakes. Replace the plug or have the supplier replace it if it is not Hospital Grade or otherwise suitable. and arrange for repair or replacement. If not correctable.7 Circuit Breaker/Fuse. (ECRI recommends 5 in [12.. Hard Service (SO. Verify that the plug is Hospital Grade (identifiable by a green dot and/or labeling). if any are evident.) A.) If a special plug is required (e. Junior Hard Service (SJO. although 18 ft [5. or at least label the cord prominently (e. Rightangle plugs are unacceptable for devices that are moved frequently.. Hospital Grade molded plugs are acceptable.5 m] has been suggested for operating room equipment. and with the device plugged in. an extension cord should not be required. If the device is protected by an external fuse. Ensure that the assembly and weight distribution is stable and that the unit will not tip over when pushed or when a caster is jammed on an obstacle (e.5 Line Cord. (Electrode lead wires have been inserted into line-cord connectors. or service organization. check the manual for the proper current rating and type and permanently mark this information on the unit housing near the fuse holder. line cord threshold).. warn users or take other preventive measures. If the device has electrical accessory outlets. The device should be mounted in a position and height where it can be easily viewed. wires. or an equivalent-quality cord should be used. verify that accessory outlets have independent overcurrent protection (fuse or circuit breaker) so that a short in a device plugged into the accessory outlet or an accessory overload will not disable the primary device.g. and visitors are protected against contact with hot surfaces. explosion proof).) A. Check that the unit is suitably constructed to withstand normal hospital use and abuse. However. adjusted. A good quality two-prong plug is acceptable for double-insulated devices. 22:301-3. If the unit has a heating element.1 Chassis/Housing. or STO). keep hoses.1. objects should not be mounted over a patient. All Rights Reserved.. verify that the accessory outlet is energized and correctly wired. A. with Molly bolts) is unacceptable except for very light devices. staff. and/or install a fused Hospital Grade (or similar quality) plug on any commonly used accessories that are not 6 Inspection and Preventive Maintenance System ©1995 ECRI. If the value and type are not labeled. ensure that it has nonslip legs or supports. If the line cord is operator detachable. (Such design deficiencies should usually be recognized during prepurchase evaluation.1. use an outlet test fixture.) Verify brake operation. even if not Hospital Grade. especially for devices that are used in the vicinity of monitors that use patient leads. Verify that the correct casters have been supplied with the unit (e. (A plug of good quality. If this is not available. a unit with venting on the top of the housing or poorly protected or sealed controls and indicators may be prone to fluid entry.1.2 Mount. then consider labeling the primary device to clearly indicate where the unit’s fuse or circuit breaker is located.Inspection and Preventive Maintenance System A. For instance.. Inspect wall-mounted devices at the time of installation to verify that the mounting technique is appropriate for the weight of the device. Especially for critical or life-support devices.g. size. verify that the fuse type is labeled and that all fuses and spares are the proper current rating and type.1. If the device is designed to rest on a shelf.1 Qualitative acceptance tests A.1. Generally. affix the cord to the unit so that it cannot be removed by the operator. If no spare fuse is provided. it should be of suitable type and quality. or SJTO).

transducers) have been supplied with the unit. To determine operating time. Check the wiring. Reversed polarity testing is not required. 500 µA in nonpatient care areas). motor.20.10 Fittings/Connectors. should be shipped with the unit and filed in the central equipment file. 18:426-7. Before connecting the equipment to ground.1. including schematics. Note: Some devices (especially devices incorporating a microprocessor. contact the manufacturer.23 Accessories. Verify that all necessary features and accessories (e. If you perform reverse polarity testing.3) on a routine basis. At least one copy each (two are generally preferred) of the instruction and service manuals. although some hospitals perform this measurement. or compressor) may be damaged by switching polarity while the device is on.. Incorrect switch wiring poses a risk to service personnel who believe that the power is disconnected when the switch is off. A warning label on the device or a poster in the area of use may be appropriate.1. Verify that other hospital equipment or systems to which the device is to be connected have the matching connectors. (Alarm features may be optional or programmable.General Devices already provided with suitable overcurrent protection. Verify that suitable connectors are supplied with the device so that adapters are not required. Measure chassis leakage current as described in Item 2.1 through 4. turn off the unit until the motor stops or for at least 10 sec before switching polarity. it may be advisable on a device of questionable quality or on devices used in the home. or defeated without adequate warning to the operator or automatic alarm reactivation after a short delay (see Health Devices 1987 Feb.2.1. then operate the device on battery power with all commonly used functions activated. See the article on Electrical Safety. A.) If no remedy is available. Measure chassis leakage current of permanently installed (hardwired) equipment during installation only. If alarm capabilities are included.2 Quantitative acceptance tests A. However. Verify that software setup parameters accessible through hidden or service menus are correctly set for the appropriate application and are consistent for all units. Inspect AC adapters used to power (or recharge) certain devices for UL (or other testing laboratory) listing and to verify that it is labeled to identify the device with which it is to be used.1. Be alert for leakage current of the device in the off mode that is greater than about 30 µA and is greater than or equal to the leakage current in the on mode. The ungrounded leakage current should be less than 5 mA. it may indicate that the on/off switch is incorrectly wired in the neutral (instead of the hot) line. All Rights Reserved. NFPA 99 specifically excludes Inspection and Preventive Maintenance System ©1995 ECRI. or contact the manufacturer. if any are found. charge the battery overnight (or install fresh batteries). A.2 Chassis Leakage Current. particularly those that are not listed. for further details and a discussion of the use of these devices in hospitals. measure the leakage current from chassis to ground. A.1. Although this may be normal and proper for the device.1. A. review the justification for purchasing this device and discuss corrective action with the manufacturer. Discuss appropriate settings with the department head and users. by measuring the leakage current from each secondary (low voltage) connection to ground. A. Verify that critical alarms cannot be turned off. For critical care monitors and therapeutic devices.) Such deficiencies should usually be recognized during prepurchase evaluation. behind the Guidance Tab of this binder. A. 16:39-44 and 1989 Dec. A copy of the instruction manual should be kept with the unit and read by all operators before the device is put in use.13 Controls/Switches. it may be desirable to disconnect the battery and determine if the device still operates on line power. silenced.20 Alarms. s s s Experience has not demonstrated the need for lead leakage and input isolation testing (Items 4. Instruction and service manuals may contain instructions regarding such modes. The leakage current should not exceed the limits for the device chassis leakage current to ground (300 µA in patient care areas.2. ECRI recommends testing of adapters.17 Battery/Charger. a user training program should be instituted to reduce the risk of incorrect use. If they do not. Devices that connect to the central piped medical gas system should have the matching DISS or quickconnect fitting for the appropriate gas. 7 . see Item A.g.

For nonisolated connections. This task focuses on identifying unique accessories and any parameters requiring measurement (e.1 Lead-to-Ground Leakage Current. if needed. At this point. Measure between each lead (except ground). These units are designed to be safe for use when connected to a conductive lead or fluidfilled catheter that is within. for a discussion of isolation). individually test each lead that may be connected to confirm that leakage current to ground is 10 µA or less with the unit ground intact and 50 µA or less with the ground open (the open ground limit is a change introduced in the 1990 version of NFPA 99). The current should not exceed 50 µA at the patient end of the cable.or battery-powered devices. either recharge the battery or equip the device with fresh batteries. can then be used to prepare a final procedure and device-specific checklist. in all normal operating modes. temperature. but continue to be careful not to contact any exposed leads. measure leakage current from each lead to the housing. This test should be performed only during acceptance testing or following input circuit repairs. and measure the resulting current (sink current) with the unit turned on and operating and the power cord grounding connector intact. Other controls should be in their normal pre-use positions. Perform the test with the device on and with the ground wire intact and open. pressure. . All Rights Reserved. Before returning to use Ensure that all controls are set properly. If the device has isolated patient connections (see the article on Electrical Safety. the leakage current should not exceed 50 µA (grounded or ungrounded). Attach a Caution tag in a prominent position on life-support equipment or any other device where the user must be aware that control settings may have been changed. since it is still possible to receive a shock. The second step is to determine the specific IPM elements that will ensure the safe and effective operation of the device. The General Devices procedure is the foundation for the template and will provide many of the IPM ingredients common to line. We recommend that these tests be performed only during acceptance testing or following input circuitry repairs. behind the Guidance Tab of this binder. If the device is of nonisolated design and is not intended to be connected to the heart by a conductive lead or fluid-filled catheter. When a new battery is installed. Be sure that a current-limiting resistor is included in the setup. 4. only one lead of the device will be in contact with the heart (or create a conductive path to the heart). 4. 4.. Lead Input Isolation. the software component of the IPM System. Measure leakage current from patient leads (or other applied parts. in all normal operating modes. Apply 120 VAC (line voltage applied through a current-limiting resistor) to each isolated patient connection individually.Inspection and Preventive Maintenance System the need for periodic lead leakage current testing.g. or in contact with. Perform this test only with an electrical safety analyzer or other setup that allows safe application of the voltage to the patient leads. Normally. IPM Task ManagerTM. methods for assessing the criteria. and the frequency for conducting the major and. If the device housing is not grounded. General Devices Checklist Template The checklist associated with this procedure is a template that can be used to develop checklists and accompanying procedures for any device.3 8 Inspection and Preventive Maintenance System ©1995 ECRI. With battery-powered devices. WARNING: Testing input isolation requires the use of a line voltage source. The first step in using the template is to place a check mark in the Major column for each item that applies to the device. the heart. measured from all the leads connected together to ground. For isolated input connections. the author of a new IPM procedure must specify performance criteria. Perform the test with the device on and with the ground wire both intact and open. label it with the date. it should be labeled “Isolated” on the front panel by the manufacturer or have the IEC symbol signifying isolation (a heart within a square). such as probes) to ground on any electrical device that has leads that are intentionally attached to or held against the patient or on any device that has a conductive invasive connection. Measure the leakage current between leads on devices with multiple patient leads or contacts. leakage current should be 100 µA or less. the leakage current should not exceed 10 µA with the device ground intact or 50 µA with the ground open.2 Interlead Leakage Current. flow). Set alarms loud enough to attract attention in the area in which the device will be used. minor IPM procedures.

The perfusionist should check pump occlusion before each procedure.Procedure/Checklist 430-0595 Heart-Lung Bypass Units Used For: Heart-Lung Bypass Units [11-969] Pumps. the arterial pump must be connected to a battery pack.g. PA 19462-1298. 1985. A number of accessories are needed for controlling and monitoring perfusion. Control and monitoring devices. Blood pumps. Hospital Assessment. depending on patient requirements. as well as to the emergency power system. provides cardiopulmonary support for a patient during open-heart surgery. Cardiopulmonary bypass.org . heart-lung machines. Overview Cardiopulmonary perfusion equipment. whichever comes first. Blood pumps propel blood through the extracorporeal circuit and return extravascular blood to the circulating volume using suction (e. permitting cardiovascular surgeons to isolate the heart from the circulatory system to perform cardiac repairs or valve replacements. see: Reed CC. and filters. A mixer valve regulates hot and cold water delivered to the heat exchanger. tubing set. intracardiac suction). 2nd ed. hours hours * Heart-lung machines and accessories should be inspected after every 100 hours of use or quarterly. Houston: Texas Medical Press. As an additional precaution. . High. Type Major Minor ECRI-Recommended Interval * NA Interval Used By Hospital months months Time Required . Blood temperature in the extracorporeal circuit is regulated to produce hypothermia or normothermia. Extracorporeal Perfusion [13-203] Also Called: Cardiopulmonary perfusion equipment. A backup arterial pump is usually provided. barring specific hospital circumstances or manufacturer recommendations to the contrary. autotransfusion. commonly referred to as heart-lung machines. Stafford T. allowing an external circuit to provide circulation and oxygenation while the heart and lungs are bypassed.) Cardiopulmonary perfusion systems usually consist of blood pumps. cardiotomy reservoir. Because continuous operation is imperative. it usually has a thermometer and water pressure relief valves to prevent overpressurizing the 009070 430-0595 A NONPROFIT AGENCY 5200 Butler Pike. and water must be delivered to the exchanger at a specified temperature. (For more detailed information on the procedure. a hand crank should be kept with each pump in the event of a power failure. bubble oxygenators are rarely used today) require that the arterial pump be positioned between the venous reservoir and the oxygenator and that it actively pump blood from the reservoir to the oxygenator.. bypass machines Commonly Used In: Operating rooms for cardiac surgery Risk Level: ECRI Recommended. heart-lung pumps. Venous blood normally requires no pumping because it flows by means of gravity to a reservoir. Oxygenators typically incorporate a heat exchanger. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. Membrane oxygenators (the most common variety. control and monitoring devices. The arterial pump propels blood through the oxygenator to the patient and may operate at up to 6 L/min. Plymouth Meeting. and a disposable oxygenator. The great vessels returning to (venae cavae) and leaving (aorta) the heart are cannulated.

but in a reversible manner. Blood contact with foreign surfaces requires that the coagulation (clotting) mechanism of the blood be controlled to a point where coagulation is inhibited. Blood taken from the venae cavae normally flows by gravity (a venous clamp may be used to regulate flow) to a venous reservoir and is then pumped through the oxygenator. Some perfusionists incorporate a filter in this shunt line as well. blood flows to the patient. Oxygenator. respectively Thermometer accurate to at least 0.Inspection and Preventive Maintenance System exchanger part of the oxygenator. Level detectors may be used to monitor the level of blood in the reservoirs. The perfusionist usually lays out the circuit. . Invasive Procedure/Checklist 434 and Pressure Transducers Procedure/Checklist 435. and tubing set. filters. since releasing clamps to change filters may cause unloading of the filtrates. An oxygen saturation meter may be used to assess oxygenation. Citations from Health Devices Heart-lung bypass machines. Temperature monitors may be used. Air bubble detectors give audible and visual alarms and may also stop the arterial blood pump if air is detected in the arterial line. 10:55. Heparin is the anticoagulant used in perfusion. or the monitors. and arterial pressures. Other devices may be used to provide blood chemistry information throughout the perfusion. usually after passing through a bloodline filter in the arterial line. may also be used) Stopwatch or watch with a second hand Hydrometer Oxygen flowmeter with 1 to 10 L/min range and 2% accuracy Graduated cylinder with at least 1 L capacity (a fluid flowmeter with 0 to 10 L/min range and 5% accuracy may be used) Large bucket (5 L) for collecting fluid when checking high flow settings 2 Inspection and Preventive Maintenance System ©1995 ECRI. 1981 Jan. as specified in Blood Pressure Monitors. A shunt around the blood-line filter permits continued flow if a clogged filter must be changed. These monitors. Improper bulb replacement causes Sarns model 7000 MDX heart-lung bypass pump failure [Hazard]. 1981 Jan. A flowmeter and bacteriologic filter are usually incorporated in the oxygen circuit. 1973 Apr. may be slaved to other pressure monitoring equipment. where it is filtered and then drained or pumped to the venous side of the oxygenator. and its level must be monitored throughout the perfusion to prevent clot formation or overheparinization. cardiotomy reservoir. Sarns air bubble detector system [Evaluation]. pulmonary artery. A special valve may be incorporated in the arterial tubing to prevent infusion of large amounts of air. Test apparatus and supplies Ground resistance ohmmeter Leakage current meter or electrical safety analyzer Equipment for inspecting blood pressure monitors and pressure transducers. Blood from the cardiotomy reservoir may be passed through an additional blood-line filter before returning to the oxygenator. These detectors are often equipped with audible and visual alarms and may also stop the arterial blood pump to avoid pumping air into the patient in the event of a low blood level in a reservoir or to avoid too much blood volume in the extracorporeal circuit in the event of a high blood level.5°C over a range of 15° to 43°C (a temperature-monitoring device made of a thermometer sealed into one leg of a Y or T connector. These disposable components form the extracorporeal blood circuit. 2:152. 1987 Jun. Delta automatic shutoff valve [Evaluation]. Oxygen is delivered to venous blood from tanks or a central oxygen supply. Suction pumps recover blood at the surgical site and return it to the circulating volume. Suction for ventricular vents may also be controlled by suction pumps. such as is used for the inspection of hypo/hyperthermia units. 16:218-9. which is made up as a sterile custom pack by a manufacturer. Pressure monitors record left atrial. 10:62. with probes placed at various points on the patient or in the extracorporeal blood circuit. A separate electrically powered heater/cooler may be used instead of a mixer to provide temperature-regulated water to the heat exchanger. Intracardiac suction returns extravascular blood to the cardiotomy reservoir. All Rights Reserved. which may be included in the console. After leaving the oxygenator. Blood oxygen and carbon dioxide concentrations are usually monitored by blood gas determinations from drawn samples. but they may be monitored using an in-line differential oxygen monitor. the drive pressure transducers.

8 1.6 1. as well as all electrical cable connectors. and bright. enter additional data on the reverse side of the inspection form. and ensure that a spare is provided. that necessary assembly hardware is present and tight. Line Cord. If any damage is suspected. Attempt to wiggle the blades to determine that they are secure. replace the entire cord. Mount/Fasteners. If the device is protected by an external fuse. such as Dow #41 graphited oil or the equivalent.1 Chassis/Housing. be sure that you understand how to operate the equipment. and check 1. open the plug and inspect it. Tubes/Hoses. Cables. consider the possibility of inappropriate clinical use or of incipient device failure. If the device has a switch-type circuit breaker. Check for evidence of leaking.7 1. If the device has electrical receptacles for accessories.4 Inspection and Preventive Maintenance System ©1995 ECRI. and the alarm capabilities. Casters/Brakes. If accessories are plugged and unplugged often. Ensure that the line cord is of sufficient length to preclude the use of extension cords. Examine the strain reliefs at both ends of the line cord and all accessory cords. carefully read this procedure and the manufacturer’s instruction and service manuals. if the unit is so equipped. If the device moves on casters. consider a full inspection of the receptacle. If any of them appear inordinate. Be sure that they hold the cord securely. Shake the plug and listen for rattles that could indicate loose screws. Examine the AC power plug for damage. temperature.Heart-Lung Bypass Units Disposable supplies. Examine each pump module and any other accessories mounted to the cart or console for security of attachment. Conductivity checks.13 Controls/Switches. Examine the exterior of the unit for cleanliness and general physical condition. Qualitative tests 1. 1. such as those on the oxygen flowmeter and water mixer. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Inspect the cables of the level sensor and bubble detector and oxygen. Look for accumulations of lint and thread around the casters. Be sure to wire a new power cord or plug with the same polarity as the old one. as appropriate. check their condition. 1. for conductive casters Torque measurement device for checking pump (if required) 1. the significance of each control and indicator. Strain Reliefs. Be sure that they are not cracked. check their positions. and be sure that they turn and swivel. If damaged.11 Electrodes/Transducers. and pressure monitors. or dirty. and their strain reliefs for general condition. AC Plug/Receptacles. are usually done more effectively as part of a check of all equipment and furniture of an area. check its value and type against that marked on the chassis.9 1. Also check line cords of battery chargers. check that it moves freely. and that there are no signs of spilled liquids or other serious abuse. Before moving any controls and alarm limits. kinked. and check their physical condition. Circuit Breaker/Fuse. 1. Inspect the cord for signs of damage. Confirm that necessary electrodes and/or transducers are on hand. Electrical contact pins or surfaces should be straight. All Rights Reserved. Check the general condition of all gas and liquid fittings and connectors.3 1. where appropriate. Procedure Before beginning an inspection.5 that it is held firmly. Record the settings of those controls that should be returned to their original positions following the inspection.10 Fittings/Connectors.2 1. 1. Check the operation of brakes and swivel locks. Check the integrity of all special mounting hardware for oxygenators and cardiotomy reservoirs. if so equipped. clean. Because some inspection items require multiple data points and several pumps need to be checked. insert an AC plug into each. Be sure that plastic housings are intact. Check the condition of all tubing and hoses in the water mixer. such as tubing and assorted fittings for connecting tubing and test equipment Conductive lubricant. 3 . Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors at each end to prevent rotation or other strain. or if the damage is near one end. cut out the defective portion.

to the extent possible.16 Fluid Levels. if so equipped. During the course of the inspection. 1. and visual displays on the unit and the charger. Quantitative tests 2. Using an ohmmeter. . and instruction cards are present and legible. 1. or multimeter with good resolution of fractional ohms. and the flowmeter float should not move. labels. Check remaining battery capacity by activating battery test function or by measuring the output voltage. Where a control should operate against fixedlimit stops. Confirm appropriate volume. 1. Be sure that hot and cold connectors are adequately placarded to prevent cross connection. 1. All Rights Reserved. Lubricate bearings if required.) 2. If the water supply used for temperature control has gauges. as well as positive stopping. and occlusion mechanisms should be within the manufacturer’s specifications. measure the specific gravity. 1.18 Indicators/Displays. pens). condensation. be sure to check that each control and switch performs its proper function. in fact. Examine the oxygen flowmeter for signs of damage or abuse. examine the valve for proper operation. it may be necessary to perform a capacity test by running the equipment until the batteries are depleted. conversion charts.21 Audible Signals. and rocking the stem from side to side with rotation. check its grounding to the main power cord. indicators. secure mounting. Check all fluid levels. and correct motion.24 Water Supply.22 Labeling.20 Alarms/Interlocks. If the unit uses a heater for temperature control. Check that. from fingernails. check the method of reset (e. Check for free play in the control valve by pushing.g.. Replenish if low. Confirm the physical condition and proper operation of all pump heads and their associated motors and transmissions. pulling. scratches. the pumps will start and function properly. Check the condition of the battery charger and. confirm that it does. If a high-temperature cutoff is incorporated in the valve. Inspect the physical condition of batteries and battery connectors.. If the unit uses a mixer valve for temperature control. During the course of the inspection. If the device has an alarm-silence feature. including those in lead-acid batteries. and if possible. check that it operates smoothly. in fact.5 Ω. verify that a variable temperature control does. charge the battery.14 Heater/Mixer. Verify that incoming water temperature and pressure controllers or limitation devices are in place. measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. Check that any associated interlocks function. Ensure that an emergency hand crank is attached to the unit and that the hand crank will turn the pump when power is disconnected. for lead-acid batteries. check its function. 1. Confirm the presence and condition of such accessories as a level sensor and an oxygenator light. The valves on some machines do not have a fixed-end stop.2 of the inspection form. Operate the unit on battery power for several minutes to check that the battery is charged and can hold a charge. If the device has an accessory outlet.1 Grounding Resistance. if so equipped. check for proper alignment. When it is necessary to replace a battery. For sealed lead-acid batteries.Inspection and Preventive Maintenance System Examine all controls and switches for physical condition. 1. Check membrane switches for membrane damage (e. 4 Inspection and Preventive Maintenance System ©1995 ECRI. Check operation of battery-operated power-loss alarms. once the alarm condition has been corrected. The stem should feel firm. take care not to overtighten.17 Battery/Charger. Be sure that all segments of a digital display function. gauges. Eccentricity of rollers.15 Motors/Pumps. Check that all necessary placards.. belt tension. (A pressure-relief valve should be used to prevent overpressurizing the oxygenator. electrical safety analyzer. verify that they are functioning. cracks. meters. 1.23 Accessories. Operate the device in such a way as to activate each audible and visual alarm. If a venous line clamp is used. Operate the device to activate any audible signals. We recommend a maximum of 0. if readily accessible. or debris. confirm the operation of all lights. 1. and note this on Line 3. determine the amount of heating. examine the heater for physical condition (e. verify that on/off controls work). as well as the operation of a volume control. label it with the date. manual or automatic) against the manufacturer’s specifications.g. such as internal nicks. check for appropriate water pressure and temperature.g. 1.

To check the pump accuracy at a mid-range flow setting. and compare temperatures. When checking water mixers.Heart-Lung Bypass Units 2. Any drop in level should be less than 1 cm/min or within the manufacturer’s specifications. Flows should be accurate to within 5% of the setting or the manufacturer’s specifications. Chassis leakage current should not exceed 300 µA. Temperature Alarms. medium. standby. operate with saline and measure flow rate by pumping saline from a “reservoir” into the graduated cylinder. be sure that thermostats permit each mode to operate while taking readings. Perform the blood pressure monitor (Procedure/Checklist 434) and pressure transducer (Procedure/Checklist 435) inspection and preventive maintenance procedures on the respective components. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened.4 2. and make sure it is within 5%. place hot water in the reservoir. Examine any associated interlocks (e. and record the alarm value. it may be useful to draw a graph of flow setting versus dial setting and placard it on the pump. the pump rollers must occlude the tubing throughout its travel across the backplate. and 38°C). including on. but record the system’s pass/fail determination on the heart-lung bypass units inspection form. and record the alarm value. At higher settings. Leave the other end of the pump open and empty. If the manufacturer provides torque specifications for the pump. For heater/coolers. Set it to deliver a known flow. immerse both ends of the tubing in a tank of saline solution or water at atmospheric pressure.9 Blood Pump Occlusion. keep the temperature-monitoring device where it was for the previous test. Be sure to indicate tubing size and brand on the graph. 2. For units incorporating high-temperature alarms. and off. and collect the volume for a convenient time interval in a graduated cylinder (a fluid flowmeter may also be used).) Operate the device in all normal modes. Alarms should occur at 42° ±1°C or within manufacturer’s specifications. For greater accuracy. Compare this flow rate with the electronically determined rate. it may be necessary to collect fluid in a large bucket and measure out volume in the graduated cylinder. Check occlusion at various roller positions on the back plate. Thermometer Accuracy. If the unit has heating and cooling modes. connect the outflow of the temperature-monitoring device to a drain. 2. 5 . (Be sure that connections at the inlet or outlet ports or conductive casters on a conductive floor do not establish alternate ground paths. This includes other equipment that is plugged into the primary device’s accessory receptacles. attach a cannula to the outflow side of the pump to simulate back pressure. Check at low. In order to operate correctly. and compare this flow to that of the calibrated 2.2 Leakage Current. Check the rollers on each pump to ensure that they are running smoothly and that there are no unusual noises from the bearings or other indications of excessive bearing wear. check this with torque measuring tools. connect the outflow of the heater or mixer to the temperature-monitoring device.10 Blood Pumps. 2. Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off. and high points in the temperature range (29°. When checking blood pump flow on pumps without direct flow setting indication. Also check operation at low and high flow settings. and record the maximum leakage current.3 Pressure Monitors/Transducers. connect the in-line temperature-monitoring device. alter the water mixture. used on some units. turn off heater) or alarms at this time. as well as equipment plugged into a multiple-outlet strip (“Waber strip”) so that all are grounded through a single line or extension cord. Thermometers should agree within 1°C. For heater/ coolers.11 Oxygen Flowmeter. With correct-size tubing in the pump. 2. and compare temperatures. All Rights Reserved. To check the accuracy of thermometers in heater/coolers or water mixers. and turn on the pump. stop flow. Check tube occlusion with a section of tubing installed in the pump and filled with water to a height of about 76 cm (30 in) above the pump. set it to deliver 3 L/min. For centrifugal pumps.5 Inspection and Preventive Maintenance System ©1995 ECRI. Use separate inspection forms. 34°.g. Check the accuracy of the flowmeter by connecting it in series with the calibrated flowmeter.. allow the unit to stabilize for 15 min. For mixers.

Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438..Inspection and Preventive Maintenance System meter. Test the accuracy of thermometers in a water bath of known temperature or with a patient probe simulator.2 3. Check the accuracy of all probes with the temperature monitor. All Rights Reserved. The valve should turn smoothly. Place a Caution tag in a prominent position so that the next user will be careful to verify control settings. 2. 37°C. Accuracy of the machine flowmeters should agree within 5% of full scale or the manufacturer’s specifications.3 Lubricate casters and motors.12 Temperature Monitors.g. It may be necessary to allow for errors in the measuring system. hypothermia monitoring) at temperatures near the high and low extremes of the range. with only slight drag.g. Thermometers should be accurate within 0. 4. Check low. 3. and 39°C. It may be useful to indicate with luminous tape or paint the direction that the hand crank should be turned for normal pump rotation in the event of power failure. setup. and the float should rise and fall freely as the flow is raised or lowered. Calibrate if required. medium. CO2).. and high ranges. if so equipped. 3. Preventive maintenance 3. Also check other flowmeters (e. Check thermometers intended for wide temperature range application (e. and function before using the unit. . Accuracy should be checked at 20°C. 6 Inspection and Preventive Maintenance System ©1995 ECRI. Before returning to use Ensure that controls are set at normal positions and that alarm volumes (if adjustable) are set loud enough to be heard in the clinical setting.1 Clean the exterior.5°C or within the manufacturer’s specifications.

As water is vaporized to increase inspired water vapor concentration and the inspired gas is warmed by convection. tracheal mucosa loses heat and moisture. . Most units have a control for varying the gas temperature. Thus. critical care areas. efficient design ensures saturation of the gas mixture leaving the humidifier. As the mucosa dries and its temperature drops. during long-term ventilatory support or anesthesia when the patient is intubated with an oral or nasal tracheal tube or tracheostomy tube. Using an artificial means to heat and humidify inspired gases minimizes the complications associated with artificial airways.. dry. and is inspired saturated and at a reduced temperature. and we prefer units that regulate the temperature by means of a patient circuit probe. The simplest units heat water by means of a thermostatically controlled heat transfer surface in contact with a body of water. units used in combination with separate temperature controllers (servo control). Usually. Plymouth Meeting.org . There is a risk of hyperthermia and respiratory tract burns if the inspired gas exceeds 40°C for an extended period of time. operating rooms Scope: Applies to servo-controlled units. hours hours Overview During normal inspiration. cool gases are delivered directly to the trachea and lungs. and the ability to clear mucus and debris is diminished. Increases in temperature and exposure time correspondingly increase this risk. collapse of the alveoli) or obstruction of the airway.Procedure/Checklist 431-0595 Heated Humidifiers Used For: Humidifiers. the mouth. recovery rooms. Controlling the temperature of the heater prevents excessive water and gas temperatures. an electrically heated.e. servo-controlled units use a temperature sensor in the patient circuit for more reliable temperature control of the gas delivery to the patient. 009073 431-0595 A NONPROFIT AGENCY 5200 Butler Pike. and non-servo-controlled units Risk Level: ECRI Recommended. secretions thicken and ciliary activity is reduced. The gas cools as it flows to the patient. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. water-filled humidifier is applied to the inspiratory gas line. we recommend monitoring inspiratory air temperature during every heated humidifier application. and pharynx warm and humidify air. nose. PA 19462-1298. Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . this natural humidification process is bypassed. thus increasing heat and moisture demand on the lower respiratory tract. The humidifier simultaneously supplies heat and humidity when the gas passes over a heated wet surface. nurseries. Heated [12-050] Commonly Used In: Respiratory care area. High. The formation of thick mucus plugs can result in atelectasis (i. producing rainout (condensation). Hospital Assessment. However. rather than reading water or heater surface temperature. which in turn heats the gas stream.

Inspection and Preventive Maintenance System

Citations from Health Devices
Heated humidifiers [Evaluation], 1987 Jul; 16:223-50. Heated humidifiers can burn infants during CPAP [Hazard], 1987 Dec; 16:404. Heated wires can melt disposable breathing circuits [Hazard], 1989 May; 18:174.

and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Test the humidifier, temperature monitor, and alarm together.

1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Check that plastic housings are intact with no cracks or poor seals that spilled fluid can penetrate, that necessary assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Check for discoloration, peeling, melted plastic, or swelling that may indicate overheating. Mount/Fasteners. Examine the mounting security of the humidifier and associated accessories. AC Plug. Examine the AC power plug for signs of damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Line Cord. Inspect the line cord for signs of damage. If damaged, either replace the entire cord or, if damage is near one end, cut out the defective portion. Be sure to wire the new power cord or plug with the same polarity as the old one. Ensure that the line cord is sufficiently long to preclude the need for extension cords. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the unit has a switchtype circuit breaker, check that it moves freely. If the unit is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare fuse is provided. If there is no provision for a spare fuse, consider installing a simple spring clip or old fuse holder. If the unit has a separate fuse for the heated circuit, be sure to check it (its type and rating are critical). Tubes/Hoses. Check the condition of all tubing and hoses in the unit. Be sure that they are not cracked, kinked, brittle, or dirty. Check for any evidence of leaking. Cables. Inspect the controller and temperature sensor cables, if any, as well as their strain reliefs, for general condition. Check reusable heated

Test apparatus and supplies
Thermometer (bimetallic or electronic) accurate to at least 0.5°C over a range of 30° to 45°C T-adapter for positioning a thermometer in series with the patient inspiratory temperature sensor of the humidifier Leakage current meter or electrical safety analyzer Ground resistance ohmmeter Source of medical compressed air or oxygen capable of providing a flow rate of approximately 10 L/min Distilled water for filling the humidifier Patient circuit or tubing for use with the humidifier Pressure gauges or meters with ranges of 0 to 30 cm H2O and 0 to 100 cm H2O (such as those provided by a pneumatic tester) with adapters for various humidifiers to be inspected (acceptance testing only) Large syringe or sphygmomanometer bulb and adapter that can be connected to the humidifier input for pressurizing it to 30 cm H2O (acceptance testing only) 1.2 1.4

1.5

Special precautions
When inspecting heated humidifiers (and other thermostatically controlled equipment), verify that the unit is not operating on its backup or secondary thermostat. If the normal (primary) thermostat fails in the on condition, the secondary thermostat will limit the temperature to protect the heater from burning out, but the heater may still generate a temperature excessive for the patient. Thus, if output temperature is high and the control thermostat does not appear to adjust it properly, the unit may be operating on its backup thermostat. Most units do not have an alarm to alert the user to this condition. CAUTION: Heater surfaces may be hot.

1.6

1.7

1.8

Procedure
Before beginning an inspection, carefully read this procedure and the manufacturer’s instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control 1.9

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Heated Humidifiers
wires for cracks, kinks, and brittleness. Verify that the wires are compatible with this unit. 1.10 Fittings/Connectors. Examine all gas and liquid fittings and connectors (e.g., patient circuit, water supply, electrical cable connectors) for general condition. 1.11 Transducers/Temperature Sensor. Check that the patient inspiratory temperature sensor is present and properly fitted into the center of its adapter for use in the patient circuit. 1.13 Controls/Switches. Before moving any controls and alarm limits, check their positions. If any of them appear inordinate (e.g., temperature control at maximum, alarm limits at the ends of their range), consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixedlimit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.14 Heater. Examine the heater or heat transfer surface for physical condition (e.g., corrosion or pitting of its sheath, deteriorated insulation). 1.16 Fluid Levels. Check that the maximum fluid level is marked and clearly visible. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, and visual displays. If the unit has a digital temperature display, be sure that all its segments function. 1.20 Alarms. Operate the unit in such a way as to activate audible and visual alarms. High-temperature alarms may need to be checked during Item 2.11. If the unit has a probe-disconnect alarm, verify that it is activated and that the heater is turned off when the probe is disconnected. 1.21 Audible Signals. Operate the unit to activate any audible signals. Confirm appropriate volume, as well as the operation of a volume control, if so equipped. 1.22 Labeling. Check that all necessary placards, labels, flow rate and temperature calibration charts, and instruction cards are present and legible. 1.23 Accessories. Confirm the presence and condition of such accessories as separate controllers, temperature sensors, and water supplies. Make sure all necessary parts are present (e.g., valve flaps, removable stoppers). 1.24 Flow/Output. With distilled water in the humidifier, connect it to a source of medical compressed air and its output to the patient circuit tubing. Set the unit for a mid-range temperature and the gas source for 10 L/min, and turn on the humidifier and gas source. Confirm that the gas flow in a bubble-type unit actually bubbles up through the water. Also check that gas is being humidified after the unit has warmed up, as evidenced by condensation in the output hose. (During major procedures, perform Items 2.1 and 2.2 before this test, so that it will be possible to proceed directly to 2.10 after this test.)

2. Quantitative tests
Perform the following tests (except Item 2.1) with distilled water added to the unit before applying power to the heater. 2.1 Grounding Resistance. Measure and record the resistance between the grounding pin of the power cord and all exposed metal on the unit (including heater sheath or surface) except small external trim pieces. Tug and flex both ends of the line cord and any connected accessory cords while making the measurement. We recommend that the resistance not exceed 0.5 Ω. Grounding resistance and leakage current measurements are not required if the unit is constructed primarily of plastic and has no exposed metal surfaces. Leakage Current. Measure chassis leakage current with the grounding connection temporarily opened. Obtain measurements with the unit off and on and with the unit on and the heater cycle on and off, and record the maximum leakage current. Leakage current should not exceed 300 µA. (Since only water vapor and condensate reach the patient through the inspiratory hose, special measurements of leakage current from the water reservoir are not required. However, if the water supply is readily accessible for leakage current measurement, this will provide further

2.2

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Inspection and Preventive Maintenance System
assurance of heater insulation integrity, especially if the sheath or heater surface is not of a grounded design.) 2.3 Low-Temperature Alarms. Verify the functions and the accuracy of low-temperature alarms and indicators. Some units alarm if they detect room-temperature gas (although this may not occur until after several minutes of operation on some units); other units have a user-selectable low-temperature alarm.

3. Preventive maintenance
3.1 Clean the exterior and heat transfer surface with a damp cloth. (Be sure that the heat transfer surface is cool.)

4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. In addition, perform the following tests. 4.1 Pressure Drop. With a T-adapter in the humidifier input, connect the 0 to 10 cm H2O pressure gauge or meter to measure the input pressure to the unit. Measure the pressure drop with 10 L/min gas flow exhausting to the atmosphere. The pressure drop should be less than 5 cm H2O for bubble-type humidifiers and much less for other units. (This measurement can be performed while the humidifier is warming up for the output temperature tests.) This test need not be performed on units that use disposable humidity chambers or units that allow complete visual inspection of the flow path, since the absence of any constriction can be verified. Leaks. Attach the syringe or sphygmomanometer bulb and 0 to 100 cm H2O pressure gauge or meter to the input and the output to seal the humidifier. Pressurize it to 30 cm H2O and observe the pressure drop over 1 min. The pressure drop multiplied by the unit’s internal compliance (specified by the manufacturer) should not exceed 6 mL. For example, if the unit’s internal compliance is 0.4 mL/cm H2O and the pressure drop over 1 min is 10 cm H2O, the leakage is 4 mL and within the 6 mL limit. To determine nonspecified internal compliance, occlude one end of the humidifier, inject 50 mL of air through the open humidifier port with a syringe, and measure the increase in pressure in cm H2O. The internal compliance equals 50 mL divided by the pressure increase. Record this value for future use.

2.10 Output Temperature. Connect the humidifier input to a medical compressed-air source and the output to the patient circuit or tubing. Attach the test thermometer adapters and the humidifier’s temperature sensor at the patient Y as close to each other as the adapters will permit. Set the temperature controller to low or mid range (35° to 40°C), set the gas source for 10 L/min, and turn on the humidifier and the gas source. When the thermometer equilibrates, record the output temperature and the temperature indicated by the unit’s temperature monitor or controller. Also, record the controller or thermostat setting. Repeat the test at the maximum temperature setting. Verify that the output temperature changes when the setting is changed to maximum. If it does not, the primary temperature control may not be functioning, and the unit may be operating on its backup thermostat. Temperature monitor and temperature settings (if so equipped) should be accurate within 1°C for servo-controlled units (other units are not calibrated). The maximum temperature of any unit should not be higher than that specified by the manufacturer. (We believe that the maximum obtainable temperature should not exceed 40°C. However, many units are capable of delivering gases at considerably higher temperatures.) 2.11 High-Temperature Alarms. Using the same setup as in 2.10, verify that the high-temperature alarm activates whenever the output gas temperature exceeds the alarm set point by more than 1°C. If the unit has an adjustable high-temperature alarm, verify alarm function at a low and high alarm setting.

4.2

Before returning to use
Adjust the temperature setting to minimum or normal. Empty or remove the water reservoir. If the unit is equipped with an adjustable alarm volume, ensure that the volume is appropriate for a clinical setting. Return the unit for processing (e.g., cleaning, sterilizing) to prepare it for patient use.

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Procedure/Checklist 413-0595

Hemodialysis Units
Used For:
Dialysate Delivery Systems, Multipatient [11-211] Dialysate Delivery Systems, Single-Patient [11-213] Hemodialysis Units [11-218]

Also Called: Dialysis machines, dialysis units, artificial kidney machines, hemodialyzers (which more appropriately applies to the dialyzer component of the machine) Commonly Used In: Hemodialysis departments, critical care units, freestanding hemodialysis treatment centers, patient homes Scope: Primarily applies to single-patient hemodialysis units, although portions may be applied to central hemodialysis systems; also see Peritoneal Dialysis Units Procedure/Checklist 455 Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval* 12 months 3 months Interval Used By Hospital months months Time Required . . hours hours

* Temperature, conductivity, and pH (if applicable) monitors should be checked by the operator before each dialysis.

Overview
Hemodialysis is used to remove accumulated waste products, organic salts, and water from the blood of a patient with impaired kidney function or to remove toxins in cases of blood poisoning. Hemodialysis units consist of an extracorporeal blood delivery unit (blood circuit), a dialysate delivery unit (dialysate circuit), a dialyzer, and monitoring units. Blood circuit. In the blood circuit, blood is taken from an artery, circulated through the dialyzer by a blood pump, cleansed, and returned to a vein. Usually, one or two needles inserted in an arteriovenous (A-V) fistula (the linking of an artery and vein) in the patient’s arm provide access to the circulatory system. The single-needle technique halves the number of punctures but requires either a Y connection and a controller to alternate withdrawal and infusion of

blood, or a special single-needle access catheter. Heparin is infused into the arterial (inflow) side of the blood circuit to prevent clotting. Blood pressure sensors on the venous side of the dialyzer (and sometimes also on the arterial side) may alarm and stop the blood pump when pressure is outside preset limits. Most units have an air-bubble and/or foam detector or blood-level detector, which clamps the venous blood line and stops the blood pump if air is detected in the venous line to prevent infusing air emboli into the patient. Newer units may combine air-bubble, foam, and blood-level detectors in one monitor unit. Dialyzer. In the dialyzer, a semipermeable membrane separates the blood from the dialysate solution. Substances from the blood pass through the membrane into the dialysate solution by diffusion, ultrafiltration,

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Inspection and Preventive Maintenance System
and osmosis. The dialysate solution initially contains none of the waste substances to be removed from the blood. The resulting concentration gradients across the membrane promote selective diffusion from the blood to the dialysate solution. Substances that should remain in the blood are present in equivalent concentrations in the dialysate solution. The dialysate solution has a lower hydrostatic pressure than the blood to promote removal of excess water from the blood by ultrafiltration. Dialysate circuit. Dialysate solution, a mixture of treated (purified) water and concentrated dialysate, is pumped through the dialyzer at a prescribed temperature, concentration, and flow rate. Dialysate solution is prepared continuously in some machines by a proportioning system that meters and mixes precise proportions of concentrated dialysate and treated water (a common ratio is 1 part dialysate to 34 parts water). This proportioning system may be a fixed ratio (i.e., proportioning a known volume of concentrate and water) or may be servocontrolled, using a control sensor to regulate the flow of dialysate concentrate. A built-in conductivity meter continuously monitors the solution before it reaches the dialyzer. Newer machines may have special proportioning and monitoring systems for different types of dialysate (e.g., variable bicarbonate, variable sodium). The dialysate solution for other machines is prepared by the simple “batch” method, but enough solution for the entire procedure must be mixed before the start of dialysis. Portable conductivity meters are used to check batch mixtures of dialysate solution. The formulation of the dialysate solution is prescribed by the physician and may be varied to meet each patient’s needs. The dialysate circuit may be housed in a single-patient unit or divided between a central unit and a number of bedside stations. A central unit may allow the bedside apparatus to be smaller and less costly than single-patient units. However, a central unit does not permit individual prescription of dialysate solution concentration. Depending on the unit used, monitoring devices in the dialysate circuit may sense dialysate temperature, conductivity, flow rate, negative pressure, ultrafiltration rate, and blood circuit leaks. Some monitors and alarms include fail-safe controls that interrupt the dialysis procedure to prevent injury. For more detailed information on dialysis, consult the Health Devices citations, particularly the 1980 evaluation of hemodialysis machines and the improper dialysate hazard, as well as Review of Hemodialysis for Nurses and Dialysis Personnel (Gutch CF, Stoner MH, Corea AL. 5th ed. St. Louis, MO: C.V. Mosby, 1993).

Citations from Health Devices
Single-patient hemodialysis machines [Evaluation], 1980 Feb-Mar; 9:87-130. Update: Gambro dialysis unit, 1980 Apr; 9:162. Reusing dialyzers and tubing sets: Pros and cons, 1980 Nov; 10:22-4. Improper dialysate [Hazard], 1983 Oct; 12:315-8. Electrical safety of subclavian catheters used in hemodialysis, 1983 Nov; 13:18-20. Peritoneal dialysis compared with hemodialysis, 1986 Feb-Mar; 15:34-5. Hemodialysis water purification [User Experience NetworkTM], 1988 Aug; 17:247. Cobe Centry 2 and Centry 2Rx hemodialysis units [Hazard], 1988 Oct; 17:313-4. Air embolism associated with hemodialysis [Hazard], 1989 Nov; 18:406-7. Technical overview: Hemodialysis machines, 1991 Jun; 20:187.

Test apparatus and supplies
Ground resistance ohmmeter Leakage current meter Thermometer accurate to at least 0.1°C over a range of at least 30° to 45°C; a temperature monitoring device made of a thermometer sealed into one leg of a Y or T connector may also be used (similar fixtures are used for hypothermia unit testing, although a separate fixture should be used for dialysis testing to avoid possible contamination) Stopwatch or watch with a second hand Syringe of the type used in the heparin pump Syringe (at least 30 cc) to generate pressure of 300 mm Hg Pressure gauge or meter capable of reading vacuum and pressure over a range of about -600 to +400 mm Hg; accuracy should be at least 5 mm Hg over the -100 to +100 mm Hg range and 5% over the remainder; necessary range depends on type of hemodialysis unit being inspected Graduated cylinder with a 1,000 mL capacity for checking flowmeter and blood pump Conductivity meter, accurate to at least 1% or standard solution to check concentration monitor

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Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

Hemodialysis Units
Expendable supplies for the device being inspected, including isolators or fluid barriers for pressure gauges or meters, blood lines, syringes, clamps, dialyzers, and dialysate solution (some of these supplies are expensive; to reduce costs, a single set of expendable supplies can be used repeatedly for inspections, except for units dedicated for isolation patients or that are suspected of having been used on patients with hepatitis or AIDS; expendables used with such units should be properly disposed of after use) Assorted fittings for connecting tubing and gauges Vacuum cleaner pH meter or standard test solutions if unit under test has pH monitor Some components covered by the following procedure (e.g., blood pump) are not built into certain older models of dialysis machines but are accessories that must be supplied by the user. Note the serial numbers of these components on the inspection form. Record the time elapsed indicated on the hour meter, if so equipped. This will help indicate appropriateness of preventive maintenance frequency and what preventive maintenance procedures to do.

1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Dialysate has a high salt concentration that will corrode and tarnish. Mount. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment. Casters/Brakes. If the device moves on casters, check their condition. Look for accumulations of lint and thread around the casters, and be sure that they turn and swivel, as appropriate. Check the operation of brakes and swivel locks, if the unit is so equipped. AC Plug/Receptacles. Examine the AC power plug for damage from abuse. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Hospital Grade plugs are strongly recommended for hemodialysis units. Base selection of plugs on their resistance to fluid infiltration; Hospital Grade plugs molded onto the line cord might be considered. If the device has electrical receptacles for accessories, insert an AC plug into each and check that it is held firmly. If accessories are frequently plugged and unplugged, consider a full inspection of the receptacle. Check for corrosion. 1.5 Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the same polarity as the old one. Also check line cords of battery chargers.

Special precautions
For some hemodialysis units, especially the more sophisticated ones, it will be impossible to perform quantitative checks on all monitoring and alarm circuits. Refer to the service manual for suggestions when the procedures described below cannot be carried out in a straightforward manner. Dialysis-grade water should be used for all inspection and preventive maintenance procedures. CAUTION: For protection against HBV and HIV, wear rubber gloves, a long-sleeved gown, and safety glasses or goggles when disassembling or testing dialysis units. Contact the infection control practitioner responsible for the hemodialysis unit to review institutional policies and procedures regarding protection from HIV and HBV. Treat machines as though they were contaminated, and consider maintaining separate, dedicated tool sets for servicing. To minimize the chance of oral contamination, do not eat or smoke in the test area. (For more information on infection control during IPM activities, see the article in this binder titled “IPM Safety.”) Since there may be water on the floor of maintenance areas, consider using ground fault circuit interrupters for electric shock protection in areas where this equipment will be tested and serviced. 1.2

1.3

1.4

Procedure
Before beginning an inspection, carefully read this procedure and the manufacturer’s instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.

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Inspection and Preventive Maintenance System
1.6 Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the device has a switch-type circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis and ensure that a spare is provided. Tubes/Hoses. It may be necessary to disassemble the unit to examine all tubing and connectors to ensure that they fit correctly. The tubing should not be kinked or mounted near rotating components, sharp edges, and fastener ends. If deaerators are used, check them for proper fluid levels and venting. Check that all seals, grommets, gaskets, and couplings are in good condition and are correctly installed. Tubing and fluid connectors should not show signs of aging, fatigue, or stress (e.g., discoloration, cracks); should not contain foreign material; and should not leak. Look for signs of leaks (e.g., corrosion or dried dialysate near a connector). Make repairs if any of the above defects are present. Ensure that all fluid path components are securely mounted to the unit. Cables. Inspect the cables (e.g., sensor) and their strain reliefs for general condition. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors at each end to prevent rotation or other strain. them appear inordinate (e.g., a conductivity or flow control at maximum, alarm limits at the ends of their range), consider the possibility of inappropriate clinical use or incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixedlimit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, check that each control and switch performs its proper function. 1.14 Heater. Examine the heater for physical condition (e.g., corrosion of its sheath, deteriorated insulation). Operate it to ensure that its controls function properly (e.g., that a variable temperature control does, in fact, determine the amount of heating; that on/off controls work). 1.15 Motor/Pump/Fan. Check all pumps (e.g., dialysate, recirculating, drain, proportioning, blood, heparin) for proper operation. Make sure they deliver fluid properly and are not excessively hot to the touch while operating. Motors should have smooth and free-running bearings and should not be excessively noisy. Check for leaks around pump seals and coupling, and make sure that pump heads and motors are clean. Clean and lubricate pumps, fans, motors, and other moving parts according to manufacturer’s recommendations, and note this on Lines 3.1 and 3.2 of the form. On batch-type units, make sure the drain screen of the dialysate delivery pump is intact and clean. Replace it if damaged. 1.16 Fluid Levels. Check all fluid levels. Test the water-loss alarm by momentarily turning off the water while the unit is running. 1.17 Battery. Inspect the physical condition of batteries and battery connectors, if readily accessible. Check operation of battery-operated power-loss alarms, if so equipped. The power-loss alarm should sound if the plug is pulled out during operation or when the unit is off and is then turned on. Check power-loss alarm batteries. When it is necessary to replace a battery, label it with the date.

1.7

1.8

1.9

1.10 Fittings/Connectors. Examine all gas and liquid fittings and connectors, as well as all electrical cable connectors, for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. Color-coded or special connectors may be used to avoid inappropriate connections (e.g., a “bicarbonate” dialysate concentrate to a “sodium” concentrate circuit). Verify that these safeguards have not been ignored or violated by the use of adapters. 1.11 Transducers. Confirm that any necessary transducers are on hand, and check their physical condition. 1.12 Filters. Check the condition of all liquid and gas (air) filters. Clean or replace and indicate this on Line 3.1 or 3.4 of the inspection form. 1.13 Controls/Switches. Before moving any controls and alarm limits, check their positions. If any of

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Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

Hemodialysis is sometimes performed through a subclavian catheter. check that it silences the alarm only for the period of time specified by the manufacturer. 1. Check the manufacturer’s recommendations for testing these units. Check sensitivity based on manufacturer’s information. 5 . bypasses) should operate properly when an alarm is indicated. Verify that venous line clamps apply enough force to completely occlude the line.21 Audible Signals. we have not included a test of fluid path isolation. Check that all necessary placards.23 Accessories. It is difficult to quantitatively assess deaeration ability in dialysis machines.20 Alarms/Interlocks. However.g. and off.2 Leakage Current. or multimeter with good resolution of fractional ohms.g. For subclavian hemodialysis. if so equipped. 1. temperature/pressure gauges or meters. venous line 2.3 Air/Foam (Blood-Level) Detector. Operate the device in such a way as to activate each audible and visual alarm. 2. Check that any associated interlocks function. standby. any hemodialysis machine connected to a subclavian catheter should have an isolated patient connection due to the risk of microshock from accidental migration of the catheter tip into the heart. If the device has an accessory outlet. During the course of the inspection. Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off. If the unit has an alarm-test switch. as well as the operation of a volume control. Ensure that all visual and audible alarm indicators operate properly. electrical safety analyzer. measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. Confirm appropriate volume. Ensure that all segments of any digital displays function. labels. air. and record the maximum leakage current. Consult the manufacturer for the best measuring point and acceptable vacuum levels or for other recommended tests. Clean sensors according to manufacturer’s recommendations. thus. as well as equipment plugged into a multiple-outlet strip (“Waber strip”) so that all are grounded through a single line or extension cord. Other interlocked functions (e. 1. Check this detector for proper operation. Verify that a low resistance exists from the ground pin to various points on the unit. including on..24 Deaeration. Chassis leakage current should not exceed 300 µA.1 Grounding Resistance. Some blood-level. Check this detector for proper operation. If the device has an alarm-silence feature. Ideally. flowmeters.22 Labeling. and follow the suggested test procedure. Inspection and Preventive Maintenance System ©1995 ECRI. and follow the suggested test procedure. All Rights Reserved. 2. we recommend using hemodialysis units with leakage current levels below 50 µA or modified units with redundant grounding or an isolation transformer. including all accessory modules. deterioration of its performance can adversely affect deaeration. 1. Ensure that all visual and audible alarm indicators operate properly. shutoffs. Clean sensors according to manufacturer’s recommendations. Verify that an emergency hand crank for the blood pump is supplied with the unit. check that it works correctly. Measure chassis and patient lead leakage current to ground with the grounding conductor temporarily opened.Hemodialysis Units 1. or foam detectors may require opaque fluid in the lines in order to function. Quantitative Tests 2. conversion charts. check its grounding to the main power cord. most units are not designed for this application. This includes other equipment that is plugged into the primary device’s accessory receptacles.. we suggest measuring the vacuum generated by the pump with a pressure gauge or meter. indicators. Other interlocked functions (e. and instruction cards are present and legible. We recommend a maximum of 0. 1. Obtain a reading with the heater cycled on and with it cycled off.4 Blood-Leak Detector. To check vacuum pumps used in deaeration systems. One of the primary components of the deaeration system is the deaeration (vacuum) pump. Operate the device in all normal modes. 2. venous line clamp. and visual displays or indicators on the unit and charger. Operate the device to activate all audible signals. and verify proper operating range. to ensure that interconnections are adequate.18 Indicators/Displays. but be aware that it does not test the sensor. Using an ohmmeter. confirm the operation of all lights.5 Ω.

percent deviation. and take the average conductivity of three samples. Keep the precision thermometer in the same position as it was for the previous test.Inspection and Preventive Maintenance System clamp.5°C or within the manufacturer’s specifications. bypasses) should operate properly when an alarm is indicated. Conductivity. establish the line and mark it on the tank. or milliohms/cm. verify that it is not due to temperature effects before adjusting the conductivity meter. (On units where this cannot be done. Test low-temperature alarms by turning the heaters off and allowing the dialysate to cool or by adjusting the limits to cause an alarm. Examine and clean the conductivity probe. On some units. The conductivity meter used for this test should have an accuracy of at least 1% and should be checked frequently against a standard solution. Set the temperature to 37°C on units with a temperature control. Set the flow rate to 500 mL/min or according to manufacturer’s recommendations. it may be possible to test temperature alarms qualitatively by infusing a bolus of hot or cold water into the dialysate line. Verify that low. or test the high-conductivity alarm by infusing a bolus of dialysate into the water line 6 Inspection and Preventive Maintenance System ©1995 ECRI. shutoffs. A fill line should be marked on the batch tank. While the unit is running at normal operating temperature. Alarms. connect the temperature monitoring device to the dialysate line at the entrance to the dialyzer (a T connection allows dialysate to keep flowing during the measurement). If the unit has an alarm-test switch. CAUTION: Incorrect dialysate conductivity may be fatal (see Health Devices 1983 Oct. Record the reading of the unit’s temperature indicator and that indicated by the precision thermometer (actual temperature) after the unit equilibrates. Monitors are calibrated in milliequivalents/L of chloride (although they measure total ionic concentration). On units with a coil dialyzer.) Verify proper function of high-temperature indicators and any other interlocked function (e. Although conductivity readings can be most accurately verified by laboratory tests. Accuracy. measure the temperature of the dialysate in the canister. Check the manufacturer’s recommendations for testing these units.5 Temperature. Record the temperature at which the alarm occurs. For units with parallel-flow or hollow-fiber capillary dialyzers. Comparison to a conductivity meter or standard solutions is an acceptable alternative. Remember that dialysate cools between the heater and the dialyzer. Accuracy. check that it works correctly.and high-conductivity alarm indicators function properly. and compare alarm temperatures with the manufacturer’s specifications. Test the high-temperature alarm functions by setting the temperature control to a value higher than the alarm limits or by the overshoot when the heaters are initially turned on (see Accuracy). the temperature in some units may overshoot the desired setting and trigger a high-temperature alarm. Return the temperature control to the normal operating temperature. . If the conductivity monitor error is greater than the manufacturer’s specification. dialysate bypass). All Rights Reserved. Record the actual alarm tem2. and ensure that the monitor is mounted correctly according to the manufacturer’s recommendations.. Check sensitivity based on manufacturer’s information. be aware that this corresponds to only one concentration of dialysate. but be aware that it does not test the sensor.6 perature. the blood-leak alarm can be tested by injecting air or milk past the photocell detector. and verify proper operating range. The temperature control and/or indicator should be accurate within 0. Alarms. If not. 2. this is inconvenient on a routine basis. some units may compensate for this cooling by increasing the temperature of the dialysate in the unit above the set temperature. If physicians at your hospital prescribe other concentrations. When the heaters are initially turned on. Verify the operation of the low-temperature alarm and any other interlocked functions. If the unit is calibrated in percent deviation.g. check for appropriate deviation readings. Allow 15 min for temperature stabilization. 12:315). Be sure to flush the conductivity meter several times with the solution to be tested before taking readings. use the manufacturer’s recommended method to take samples. See the instruction or service manual on how to conduct this test.

Hemodialysis Units and test the low alarms by disconnecting the dialysate supply. use a standard transducer protector (isolator) when making these measurements. whichever is greater. The reading should be accurate within 10 mm Hg or within the manufacturer’s specifications.9 2. water-. Blood Pump Occlusion. Monitor. repeat the test for the other monitors. Check the accuracy of the flowmeter by setting it to deliver a known flow rate (vol/min) and collect the dialysate flow via the drain line in a 1.8 Heparin Pump. Indicate tubing size and brand on the graph. The monitor should be accurate within 10 mm Hg or 10% of the reading. or within manufacturer’s specifications. and operate it for a measured time interval. and pressurize the tubing to 300 mm Hg with a syringe attached to the remaining port of the T or Y fitting. 2. Accuracy should be within 10%. Monitor. since elevation errors are approximately 20 mm Hg/ft. Check dialysate flow rate at low (minimum). or heparin-filled syringe of the type actually used with the unit. The position of the gauge or meter relative to the dialyzer is important. Verify that other interlocked functions operate properly. Connect the sphygmomanometer bulb to the remaining port of the connector.000 mL graduated cylinder for a specified interval. Record the values at which the alarms occur. and read the pressure on both the monitor and the test gauge or meter. All Rights Reserved. Set the pump to a rate typical of actual use. With the pressure gauge or meter still connected. Check rollers to make sure that they function smoothly and that there are no unusual noises from the bearings or other indications of excessive bearing wear. Check the accuracy of the pump at a mid-range flow rate by setting it to deliver 200 to 250 mL/min and collecting the volume in a 1. Alarms. medium. Check that all markings are legible. Verify that the appropriate audible and visual alarms function when the dialysate pressure exceeds the preset high and low limits. and high (maximum) flow settings. Check the negative pressure monitor at low. 2. Disconnect the power and verify that the hand crank will turn the pump. On pumps without direct reading of flow rate. Alarms. To prevent contamination. On one side of the T connect a pressure gauge or meter. it may be useful to draw a graph of flow rate versus dial setting and placard it on the pump. Verify that all other interlocked alarms function properly. Occlude the tubing segment with one roller of the pump. 2. Check that the pump alarms and turns off when the plunger reaches the end of its travel.12 Negative Pressure.7 Blood Circuit Pressure. Calculate the delivery rate from the syringe graduations. Ensure that an emergency hand crank is attached to the unit. Refer to the manufacturer’s manual to determine where to place the gauge or meter for this test. immerse both ends of the tubing in a tank of saline solution or water and start the pump. verify that the appropriate audible and visual alarms function when the low and high blood pressure alarm limits are reached. With cor- Inspection and Preventive Maintenance System ©1995 ECRI. Flowmeter accuracy should be within 10% or within the manufacturer’s specifications. or high levels with a vacuum gauge or pressure meter and a Y or T connector (some units have a sampling port in the dialysate line that can be used). Repeat this procedure for the other roller. and check that they are within the manufacturer’s specifications. 2. Check tube occlusion by connecting a T fitting to the outflow end of the tubing. Also check operation at low and high flow settings. 7 .11 Dialysate Flow Rate. rect size tubing in the pump. The monitor should be tested at three different pressures to ensure that it is accurate over the entire range. 2.000 mL graduated cylinder for a specified period. Machines with fixed flow rates or single-pass converters may be checked similarly. Check the accuracy of blood circuit pressure monitors by connecting an accurate pressure gauge or meter and the existing pressure monitor to a T or Y connector (see Sphygmomanometers Procedure/Checklist 424).10 Blood Pump Flow Rate. Flows should be accurate to within 10% or the manufacturer’s specifications. medium. Confirm that other interlocked functions operate properly. Check heparin pump accuracy with a saline-. Any drop in pressure should be within the manufacturer’s specifications. increase the pressure. If there is more than one monitor.

confirm that they are functioning. 8 Inspection and Preventive Maintenance System ©1995 ECRI. setup.6. Test the pH monitor in a manner similar to Item 2. Replace any tubing segments or other items according to the manufacturer’s recommendations. but both of these parameters of prepared dialysate may be compared to values obtained by a laboratory blood gas/electrolyte analyzer.13 Additional Features. The variable sodium and bicarbonate features may be inconvenient to test.. if so equipped. 3. are set loud enough to be heard in the clinical use area. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.4 4. ultrafiltration [UFR]. All Rights Reserved. If quantitative testing of UFR meters is not possible.2 Lubricate where appropriate. Lubricate motor and pump heads according to the manufacturer’s specifications. Clean flowmeters. 3. Test additional features (e. Place a Caution tag in a prominent position so that the next user will be careful to verify control settings.Inspection and Preventive Maintenance System 2. if adjustable.g. (Use reverse side of inspection form to record test results. Testing of the ultrafiltration control is essential for high-flux machines. Clean or replace fan filters. and function before use. Preventive maintenance 3. single-needle controllers) according to the manufacturer’s specifications.) 3. variable sodium and bicarbonate features. .1 Clean the exterior and interior of the unit. if required. Vacuum air vents and cooling fans. Replace lights if necessary. pH meters. according to the manufacturer’s instructions. Before returning to use Disinfect the device as recommended by the manufacturer. Make sure controls are set at normal positions and alarm volumes.

Procedure/Checklist 465-0595 Ho:YAG Surgical Lasers Used For: Lasers. orthopedic operating rooms Scope: Applies to general-purpose holmium:YAG surgical lasers that include contact and/or noncontact flexible fiberoptic delivery systems (either reusable or disposable). Type Major Minor ECRI-Recommended Interval Used 12 months 6 months Interval By Hospital months months Time Required . also does not apply to other ophthalmic lasers or to CO2 lasers. or other surgical lasers. holmium lasers. orthopedic lasers Commonly Used In: Operating rooms. Manufacturers or outside service vendors often maintain lasers for hospitals. abrupt interruption of a surgical procedure.org . hours hours Overview Ho:YAG lasers are normally checked before each use by the laser’s power-on self-test and by user examination of the aiming beam and the delivery system to be used. cardiovascular surgery. PA 19462-1298. angioplasty lasers. The output power of the laser is the product of the energy per pulse times the 232619 465-0595 A NONPROFIT AGENCY 5200 Butler Pike. does not apply to holmium:YAG lasers used solely for ophthalmic surgery. both the energy per pulse and pulse rate are user settable. or damage to the laser system. In addition.5 mm of the tissue surface. thulium:YAG lasers. catheterization laboratories. endoscopy laboratories. However. High. Plymouth Meeting. neurosurgery. Ho:YAG lasers emit a train of energy pulses. Ho:YAG surgical lasers affect tissue by delivering invisible. emit near-infrared energy at 2. causing less tissue to be vaporized and allowing some coagulation effect. Hospital assessment. This minimizes the need for frequent additional periodic testing. cystoscopy rooms. Surgical. surgical lasers. Cutting hard tissue may require high energy per pulse. while a smooth cut may require a fast pulse rate. Moving the fiber tip away from the tissue lowers the power density.and high-power holmium:YAG surgical lasers that are typically used for general surgery. Holmium:YAG [16-943] Also Called: Ho:YAG lasers. mid-infrared energy at a sufficient power density to cause vaporization and/or coagulation. many of the tests listed herein can be used or modified for these other lasers Risk Level: ECRI-recommended. urology. applies to low. and ENT surgery procedures. the range of energy per pulse and the number of pulse rate combinations are limited by the laser’s power capability. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. The 2. These lasers must be meticulously maintained to ensure proper and safe operation. gynecology. however. . arthroscopic lasers. The extent and frequency of inspection by hospital personnel should be coordinated with these outside services. orthopedic surgery. Failure of a Ho:YAG surgical laser can cause patient or staff injury.100 nm. YAG lasers (incorrectly). short procedure areas. Ho:YAG surgical laser fibers are most often used in contact with or close to tissue to cause vaporization. bronchopulmonary. mid-infrared Ho:YAG energy is preferentially absorbed by water and is typically absorbed within 0. and can provide sufficient power output to coagulate and vaporize tissue.100 nm. gastroenterology. Nd:YAG lasers. urology lasers. argon lasers.

Laser energy can cause serious injury. The fiber may be used with additional devices (e.Inspection and Preventive Maintenance System pulse rate — for example. Under some circumstances. or connected to a water supply and drain. General-purpose Ho:YAG surgical lasers have a laser cavity that houses an yttrium-aluminum-garnet (YAG) crystalline rod doped with holmium (Ho). Most Ho:YAG lasers use water/air cooling systems that are self-contained. the beam may not diverge significantly. high voltage (optional) Grounding strap (optional) Special precautions Inspecting and maintaining lasers is a dangerous as well as necessary process. which would require a 10-watt laser. Since the therapeutic and aiming laser beams are transmitted through a single optical fiber. which emits visible light (typically red). particularly when the internal interlock is overridden or in any other situation in which the energy does not diverge significantly over long distances. 1995 Mar. These attachments can be used to focus the energy into a small spot size at a known working distance and or a specific beam direction to accomplish a special task (e. Ho:YAG surgical lasers [Evaluation]. 1992 Sep.g. As a result. In a well-aligned system.) Energy leaving the laser tube through a partially reflecting mirror is typically directed into a flexible optical fiber that transmits the laser energy to the tissue.. a second. tongue depressors. nontherapeutic aiming helium-neon (He-Ne) laser or laser diode. Misalignment of the beam at the fiber entrance would result in decreased power output or loss or distortion of the aiming beam. Like most lasers. which deliver a range of power through a variable energy and fixed pulse rate that is faster than Ho:YAG’s. This differs from most other lasers. but not 1. through an endoscope). any significant problem with the therapeutic beam pattern introduced by an accessory would be apparent by examining the visible aiming beam.g. . 1″ or more wide. Ho:YAG lasers are inefficient in converting electrical energy into laser energy. Therefore. the YAG crystal is also doped with thulium [Tm] and chromium [Cr]. 24:92122. A 5-watt laser may allow both of these settings. and/or with a laser handpiece or a laser micromanipulator (used to interface the laser with the surgical microscope). travels the same path) with the Ho:YAG laser beam. which improve the laser’s efficiency.g. these two beams are coincident as they exit the fiber. connected to a freestanding chiller system. Citations from Health Devices Laser use and safety [Guidance article].. unlike those lasers that use mirror delivery systems (e.0 J × 5 Hz are both 5 watts. even a full room length or more away from the laser (and can harm tissue or burn material even at this distance). All Rights Reserved. exercise great care whenever a laser beam is accessible. it is not necessary to periodically verify coincidence of the aiming and therapeutic beam or to assess the therapeutic beam pattern (e. and far greater care is required than with most devices.0 J and 10 Hz. with special tips. 0. Test apparatus and supplies Leakage current meter or electrical safety analyzer Ground resistance ohmmeter New. articulating arms on CO2 lasers). unused fiber delivery system Black Delrin block 1⁄2″ or more thick.. excess heat is generated in the laser cavity. Personnel who inspect or service lasers should receive special training from the manufacturer or from a qualified alternative training source. about 3″ to 4″ long.. 21:306-10. or firebrick Laser radiometer (power meter) Laser safety signs Laser safety eyewear specifically designed for use with Ho:YAG surgical lasers and of sufficient optical density to protect the wearer’s eye from laser injury Vise with padded jaws or ring stand with padded clamp Pressure gauges and coolant system tee fitting Outlet test fixture (optional) Insulating gloves. Because the mid-infrared energy emitted by the Ho:YAG laser is invisible. simultaneously traverses the fiber and is coincident (i. 2 Inspection and Preventive Maintenance System ©1995 ECRI. With Ho:YAG lasers. focused energy emission at a right angle to the fiber for sclerostomy).e. TEM00) within the beam or spot. (In most Ho:YAG lasers..g. Area security and use of personnel protective devices and practices should be consistent with hospitalwide laser safety procedures and/or should be approved by the laser safety committee. Any beam pattern distortion at the fiber entrance would be eliminated as the laser beams travel through the fiber because of internal reflections within the fiber.5 J × 10 Hz and 1. requiring a cooling system.

Similarly. Do not use the laser in the presence of flammable anesthetics or other volatile substances or materials (e. or insulate high voltages carries the appropriate insulation rating (e. drain. General. and that there are no obvious signs of water or oil leakage. perform tests with the unit turned off. WARNING: Laser safety eyewear does not protect the wearer from the aiming system light. black Delrin) when the laser is to be activated. in good working order. A second person should be present. be sure that you understand how to operate the equipment. Do not stare directly into the aiming system beam or the therapeutic laser. that assembly hardware is present and tight. If the procedure must be interrupted.g. Procedure Before beginning the inspection. disconnect the laser from line voltage. Be sure that all housings are intact and properly aligned. preferably. ensure that they operate smoothly and correctly. determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Check that mounts or holders intended to secure the fiber to the fiber support (to protect the fiber when in use) are present. the significance of each control and indicator. Target materials will ignite when exposed to high laser energies. Consult the manufacturer’s recommended procedures for servicing high-voltage laser circuits. 1.. disconnect the laser from line voltage before entering the laser cabinet. Capacitors may store charges long after the device has been disconnected from line voltage. windows should be covered with nonreflective material to prevent transmission of laser energy to other areas. because of the serious risk of explosion and fire.g. If manual shutters for the aiming system or the therapeutic laser are accessible. as well as to the hospital risk manager. carefully read this procedure and the manufacturer’s operator instructions and service manual. Also. Some surgical lasers use high voltages (e. Shutters. use a firebrick or other nonflammable material behind the target material (e. at minimum. that any retractable parts slide easily and lock in place if so constructed. it should be in the Standby/Disabled mode. use short durations when practical. Where possible.e. 3 .1) before any other test that requires operation of the laser. Qualitative tests 1. 20 kV). Do not perform these procedures when a patient is present or clinical staff is working. and inform users of the importance of storing the key in a controlled location. which can be lethal. Do not switch it to the Operating mode until the procedure is about to begin and the laser and its delivery system are properly positioned.1 Chassis/Housing. and avoid contact with any portion of the high-voltage circuit until you are certain that the charge has been drained. and do not aim the laser across a path that a person might normally use as a thoroughfare. even when wearing laser safety eyewear. The laser should remain in the Off position when not in use. Furthermore.. especially during procedures of recognized risk.) Examine the exterior of the unit for cleanliness and general physical condition. Inspection and Preventive Maintenance System ©1995 ECRI. Verify that the key has not been left in the laser. 1. and precautions needed to ensure safety and avoid equipment damage. use a redundant ground strap if you must enter the laser cabinet. Because of the presence of high voltage.2 Mounts/Holders. and use insulated gloves for those procedures in which contact with a high-voltage source is possible (and the gloves are not otherwise contraindicated). Report any laser accident immediately to the laser safety officer or equivalent. and being used. (Remove it if it has been. Whenever possible. When in use. Avoid placing the laser beam path at eye level (i. When possible. a good ground must be present. Ensure that equipment intended to be used to measure.g. to summon help in case of an accident. or in oxygen-enriched atmospheres. post doors to the room with appropriate laser safety signs stating that the laser is in use and that it is unsafe to enter the room without authorization by the service person performing the procedure. Users should wear appropriate laser safety eyewear at all times whenever the laser is in the Operating mode.Ho:YAG Surgical Lasers In addition. alcohol). A CO2 fire extinguisher should be readily available. when kneeling.g. and remove the laser operation key and store it in a controlled location... that there are no signs of spilled liquids or other evidence of abuse. perform the Grounding Resistance test (Item 2. In such cases. or standing).. Be sure to leave the shutter in the proper position for normal operation. sitting. All Rights Reserved. above 20 kV). Remove from the working area or cover with flame-resistant opaque material all reflective surfaces likely to be contacted by the laser beam.

Ensure that a spare is provided or readily available. cut out the defective portion. AC Plug/Receptacle. Tubes/Hoses. secure mounting. Liquid fittings should be tight and should not leak. be sure that each control and switch works properly.12 Filters. Before moving any controls. Examine all controls and switches for physical condition. Measuring the pressure drop across a liquid filter can be helpful in determining whether the filter should be replaced. If the device is protected by an external fuse(s). from fingernails.10 Fittings/Connectors. Check that the casters roll and swivel freely. check for proper alignment as well as positive stopping. If the device has a switch-type circuit breaker. and bright. be sure to check that each control and switch performs properly. and correct motion. Examine all controls and switches for general physical condition. Check that they are of the correct type. liquid. ensure that the cable and any connectors are in good condition..g.Inspection and Preventive Maintenance System check mounts or holders for other devices (e. Clean or replace filters according to the manufacturer’s recommendations (e.8 1. Electrical contacts should be straight. check its value and type against what is marked on the chassis or noted in the instruction or service manual.. During the inspection.6 1. Verify that the mounting apparatus is secure and that all hardware is firmly in place. . Remote. Some Ho:YAG surgical lasers require deionized water. If you find such evidence. notify users to avoid using tape and sharp instruments.4 1.g. open the plug and inspect it. If you suspect damage. Where a control should operate against fixed-limit stops. Line Cords. 1. Cables. and indicate this in the preventive maintenance section of the inspection form. fiber). Ensure that any mechanism to close off the laser aperture (fiber port) is clean. There should be no visible dirt or residue in the optical path of the laser aperture. Be sure that they grip the cord securely. Be sure that housings are intact. or be caught in moving parts. 4 Inspection and Preventive Maintenance System ©1995 ECRI. If a cord is damaged. If any position appears inordinate. that assembly hardware is present and tight. that they are connected correctly and positioned so that they will not leak. that they have not become cracked and do not show other signs of significant abuse. 1. and that they are secured adequately to any connectors. external power meters. operates smoothly.. Examine the strain reliefs at both ends of the line cord. General. consider the possibility of inappropriate use or of incipient device failure.3 Casters/Brakes. Clean or replace air filters and radiators that are obviously dirty. trail on the floor. check and record their positions. Wiggle the blades to determine whether they are secure. If the remote control is attached by cable to the laser. Examine the exterior of the control for cleanliness and general physical condition. Check the operation of brakes and swivel locks. if the damage is near one end.. and electrical fittings and connectors for general physical condition. pens. Examine cables carefully to detect breaks in insulation and to ensure that they are gripped securely in the connectors at each end to prevent strain on the cable. Check membrane switches for tape residue and for membrane damage (e. Check the condition of all liquid and air filters.13 Controls/Switches. During the course of the inspection. 1. check for proper alignment as well as positive stopping. Check the condition of all coolingsystem hoses and any other hoses or tubing the laser may have (e. replace the entire cord or. kink. Inspect line cords for signs of damage.7 1. 1. and that there are no signs of spilled liquids or other serious abuse. Examine all optical (e.g.5 1. replace if the pressure drop is >5 psi). Shake the plug. and listen for rattles that could indicate loose screws. Circuit Breakers/Fuses. Strain Reliefs.9 1. All Rights Reserved. correct motion.g. Be sure to wire a new power cord or plug with the correct polarity. If a control has fixed-limit stops. surgical instruments). If the device is mounted on a stand or a cart. Examine the AC power plug for damage. and intended range of settings. drain). clean. and most require special filtration.g. and is in use.. Inspect all cables and their channels or strain reliefs for general physical condition. secure mounting. check that it moves freely. footswitch). examine the condition of the mount.

1.g. ensure that each display provides the information expected. Check the physical condition and proper operation of these components. indicators. undamaged sheath) fiber or handpiece should be used for this test. note this in the preventive maintenance section of the inspection form.g. fiber. the laser may automatically recalibrate itself and/or adjust the displays so that the power indicated to be delivered to the patient will be correct.. ensure that it works. Be sure to check Inspection and Preventive Maintenance System ©1995 ECRI. Verify that this feature is functioning by using the manufacturer’s recommended calibration procedure to test one delivery system (e. settings. check or replace the battery (periodic prophylactic battery replacement is often preferred to risking battery failure during use).g. Some footswitches include two internal switches.g..) After deactivating the laser and reclosing the door or window. Operate the device in a manner that will activate the self-check feature. Refill or change the fluid according to the manufacturer’s recommendations. If a feature to manually reset this information is available. Flex the cable at the entry to the switch. if present. and verify that it is correct.. and visual displays on the unit and remote control. Examine the male and female connectors for attaching the footswitch to the laser cabinet to be sure that no pins are bent and that no other damage is present. coolant) levels. or it may require the user to do this manually. meters. (Do not disassemble major parts of the laser to test internal interlocks. Note any error messages displayed during the power-on self-test. Clean any obvious dust from these components. Store some sample information.. All Rights Reserved. During the procedure. verify proper operation of all lights. Some holmium:YAG surgical lasers include a user-accessible calibration port or power meter that allows output calibration and/or testing of the laser fiber. If lubrication is required. and note this in the preventive maintenance section of the inspection form. Ensure that user prompts occur in the proper sequence. >85% transmissibility. 1.20 Alarms/Interlocks.15 Motors/Pumps/Fans/Compressors. 1. be sure to test only those alarms that will not cause damage to the laser or present an unnecessary risk of laser beam exposure to yourself or bystanders. verify the operation of both. even through a shoe. Check that the internal switch is operating and that the footswitch does not stick in the On position. if readily accessible. label it with the date. If a door or window interlock is used. Examine the footswitch for general physical condition. When it is necessary to replace a battery. If no self-check feature is present. and using an ohmmeter. 1. including evidence of spilled liquids.16 Fluid Levels. pulse or accumulated energy counter). ensure that it deactivates the laser properly.18 Indicators/Displays. Ensure that the connector secures acceptably to the laser cabinet. Inspect the physical condition of batteries and battery connectors. check to be sure that the laser will restart. in this case. Based on the measurement from the calibration power meter. check to be sure that the laser activates consistently when the footswitch is depressed. This feature is provided because transmission of laser energy through a fiber may change as a result of fiber use. It is usually possible to feel the vibration caused by closure of the switch. If primary and remote-control indicators and displays can be used at the same time or if control can be switched from one to the other during the course of a procedure. gauges. Footswitches for lasers include an internal switch that activates according to the depth of pedal depression.g. A good-quality (e. handpiece) that the manufacturer indicates can be acceptably calibrated using these procedures. and verify that all visual and audible alarms activate according to the manufacturer’s documentation.Ho:YAG Surgical Lasers Footswitch. 1. operate the laser in a manner that will activate each audible and visual alarm. displays) is indicated on both control panels during laser operation. Ensure that all segments of a digital display function. verify that the same information (e.19 Laser Delivery System Calibration. If a remote control or display is battery powered. During the course of the inspection. 1. Confirm that strain reliefs are secure. if present.. If display screens or digital displays are provided for user prompts or for viewing accumulated information (e. 5 . Check all fluid (e.17 Battery. check for internal wire breaks that cause intermittent operation.

and ensure that it fits snugly. tips. when assembled. Be sure to handle it by the main body. Be sure that all hardware (e. threads) are in proper working order.g. Consult the manufacturer’s recommendations for the procedures and cleaning agents to use to clean reflecting surfaces and lenses. Consult the manufacturer’s recommendations for the procedures and cleaning agents to use to clean lenses. Handpieces. Carefully insert each lens into the micromanipulator. (For some lasers. 6 Inspection and Preventive Maintenance System ©1995 ECRI. Do not touch the lens surface. The fiber should be repaired and/or cleaned according to the manufacturer’s recommendations. the function of the interlocks can be checked using an ohmmeter. or snaprings. coolant channels) is present.. Check to see that an instruction manual is kept with the laser or is readily available. Inspect micromanipulators provided by both the laser manufacturer and the laser accessory manufacturer. and firmly attached. making the laser potentially unavailable. test this feature to be sure that it deactivates the laser and that the laser will subsequently restart. examine the connector. and verify that the signal can be heard in the environment in which the laser will be used.Inspection and Preventive Maintenance System the interlocks in all locations where the laser is used. lenses) for cleanliness and general physical condition. Set up reusable accessories with the laser to ensure compatibility and proper functioning.. Fibers.. If a finger rest is present.3) are present and legible. 1. Examine the microscope micromanipulator for cleanliness and general physical condition. Examine each handpiece component (e.. remove it from service. Verify fiber performance. . For the test fiber or before each use.22 Labeling. are secure.g. (Do not remove other parts that are press-fit or attached by screws.g. Operate the device to activate any audible signals (e. Connect the micromanipulator to the microscope to check for a secure connection. Inspect the mechanism used to attach the micromanipulator to the microscope to ensure that all parts are present and that it is in good working order. Ensure that the connector properly seats into the laser aperture of the laser cabinet.23 Accessories. Verify that all necessary accessories are available and in good physical condition. setting change). Examine each objective lens to ensure that it is intact and clean. Be sure to check with the person responsible for scheduling the use of the laser before beginning the procedure. Checking all fibers or accessories during a single inspection and preventive maintenance procedure is unnecessary as long as accessories are routinely checked by the person(s) responsible for laser setup and operation. General. Examine individually only those components that are intended for removal during normal use and storage. 1. be sure not to touch the lens surface. cable.g. and instruction cards noted during acceptance testing (see Item 4. notify the person(s) responsible for fiber repair. labels. body. Ensure that the mechanisms used to connect the handpiece(s) to the fiber are in good working order and that they reliably secure each handpiece to the fiber. do not hold it by the joystick. laser emission. for cleanliness and general physical condition. 1. Check that all placards. and tip of each fiber to be used.21 Audible Signals. Microscope micromanipulator. All Rights Reserved. handle lenses by the edges only. ensure that it is firmly attached and properly oriented. Examine the joystick to ensure that it is firmly attached and that it freely moves the reflecting lens. and do not touch the reflecting surfaces or lenses in the body. Consult the manufacturer’s recommendations for the procedures and cleaning agents to use to clean the objective lenses. If a zoom focus feature is present. as well as the fiber support. If a fiber appears to be dirty or damaged. Ensure that major subcomponents of the handpiece. In addition. Check for proper operation. If a fiber is reusable. in good condition. bolts. Examine the distal end of fibers to ensure that any connecting mechanisms (e.) If lenses are detachable.) If the laser is equipped with an emergency “kill” switch. be sure that it turns easily and does not slip. Ensure that the reflecting surfaces and lenses are intact and clean. many of the accessories are sterile and require resterilization before use.

With the laser attached to a grounded powerdistribution system. test that setting changes made throughout the range result in the expected performance. 2.2 2. electrical safety analyzer. and maximum repeat pulse settings. or micromanipulator attached.6 Inspection and Preventive Maintenance System ©1995 ECRI. and activate the laser at each setting.Ho:YAG Surgical Lasers Safety filters. verify that each color is present and working properly. and verify that it produces a round. which repeats the pulse at a fixed or adjustable rate.5 Footswitch Exposure Control. There should be no visible dirt or residue in the optical path of the laser aperture. measure the leakage current between the chassis and ground with the unit grounded and ungrounded. activate the unit.1 Grounding Resistance. maintaining the same distance. 2. Adjust the exposure setting in increments of 0. use the following alternative test method. Be extremely careful to keep hands out of the laser beam path. and have developed a series of burns. If several color choices are available for the aiming beam. Place and secure the laser fiber. Continue this process until you have tested all exposure settings. and footswitch. For handpieces that provide adjustable spot sizes. test the laser to be sure that the correct power is repeatedly delivered over the correct time period. (If the footswitch is of low voltage. and release the footswitch after about 1 sec. It should be clean and undamaged.3 Exposure Duration. or micromanipulator with the aiming system focused on the target material (e. grounding is not required.25 Laser Aperture. Activate the aiming beam (without the therapeutic beam). ensure that appropriate grounding is present. This test can be done in conjunction with power output measurements with some power meters. test this feature with the laser set at the minimum. With the laser set to about 10 W and the exposure set at minimum duration.g. with no halo. or multimeter with good resolution of fractional ohms to measure and record the resistance between the grounding pin on the power cord and exposed (unpainted and not anodized) metal on the chassis. except continuous. Similarly. However. If you are using such a power meter. Set the output time for about 5 sec.. clean or replace if needed. Pulse Rate. blast shield) behind the laser aperture.5 Ω. Quantitative tests 2. if adjustable. accessory outlet. if present. If the number or duration between repeat pulses is adjustable. ground pins. Check that the intensity control. and verify that the repeat pulse feature operates as expected by moving the target material slightly between each pulse. Should your power meter be incapable of measuring pulse rates.1 sec or the next longest duration. activate the laser and create a burn.24 Aiming Beam. does change the brightness of the aiming beam. If the power meter can react to pulse duration (this is the preferred circumstance). Improper attachment of conductors may damage the laser. use the following less preferable alternative. Carefully move the target material to expose a clean area. Set the laser to about 10 W and a 0. Verify that the beam turns off when the footswitch is released. All Rights Reserved. WARNING: Do not reverse power conductors for this or any other test.1 sec exposure duration with the fiber. 7 . Use an ohmmeter. in no case should it exceed 500 µA. If the unit includes a Repeat Pulse feature. black Delrin or a tongue depressor). 1. 2. output from a high-speed IR photodiode circuit and oscilloscope 2. If your laser power meter cannot be used for this test. Compare the burns to verify that progressively larger burns occurred as the exposure duration increased. Some laser power meters can measure pulse duration. verify that the spot size changes as expected and still remains uniform. uniformly bright spot. handpiece.) Leakage Current. The leakage current on the chassis should not exceed 300 µA.g. WARNING: Make this inspection with the laser powered off. Remove and inspect the protective window (e. if the laser power meter does not measure pulse duration.4 Repeat Pulse. 1. handpiece.. 2. check pulsing controls to verify that the aiming beam can be pulsed. median. Some laser power meters can react quickly enough to be used to test this feature of the laser. test the laser at each setting. We recommend a maximum of 0. Verify operation of safety filters in the microscope and endoscope delivery systems. Where it is greater than 300 µA.

Secure the delivery system at the appropriate distance from the detector of the laser power meter to meet spot-size requirements specified in the instructions for the meter. In addition.. a line cord. In addition. Select one delivery system (e. 3. medium (e. do not switch conductor connections or wiring configuration for any tests. compare the reading obtained with the reading taken on incoming acceptance testing. mW) feature. 10% of full scale). Because of the heightened risk associated with an unfocused. perform the following tests.. threshold). Lubricate any motor. eyewear. fiber. or after the last service procedure.g.) Compare the reading with the power display of the laser. the measured and displayed values should all be within 10% of one another. turn off the unit being tested before switching polarity.g. Clean accessible optical components (e. Ensure that all hoses and tubes are tight. Replace filters if needed.. If reverse-polarity leakage current measurements are made. and you must know and meticulously follow the power meter’s instructions for use.1 Clean the exterior. if present. the measured and displayed values should all be within 10% of one another..2 8 Inspection and Preventive Maintenance System ©1995 ECRI. If the laser beam is focused on the detector. With the laser set at minimum and maximum pulse rates and at one mid-range setting between the minimum and maximum pulse rates. using techniques and cleaning solutions recommended by the manufacturer. compare the reading obtained with the reading taken on incoming acceptance testing.g. or after the last service procedure. and ensure that laser signs.) WARNING: Accessing the unfocused laser beam may require defeating internal interlocks.1 Areas of Use. If the device is designed 4.g. In addition. Thus. and perform the manufacturer’s recommended user calibration procedure. pump. 3. 50% of full scale). and maximum output. at the last preventive maintenance procedure. it may be damaged. Check all fluid levels. Calibrate/adjust any components (e.. All Rights Reserved. are functioning properly. Do not conduct electrical leakage current tests with reversed-polarity wiring.g. (Do not focus the beam to a small spot on the power meter. Compare the reading with the pulse rate display of the laser. 2. If the laser includes a low-power (e. compressor. including leakage current measurement. handpiece. Also test the ability of the laser to deliver laser energy as expected in all configurations and with all provided laser accessories. or printer components as recommended by the manufacturer. Ensure that the assembly is stable and that the unit will not tip over when pushed or when a caster is jammed on an obstacle (e. Acceptance Tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. nondiverging laser beam.. microscope lenses). WARNING: Lasers may be damaged by switching between normal and reverse polarity while the device is on. fan. Visit the area(s) in which the laser is to be used. and supplement or replace fluids if needed. at the last preventive maintenance procedure. printer) according to the manufacturer’s recommendations.. Also. Only appropriately trained personnel should attempt laser adjustments.3 3. Some power meters require that the unfocused or a defocused laser beam be projected into the detector to cover the majority of the absorber surface.Inspection and Preventive Maintenance System can be used to measure the number of pulses per second. activate the laser at its minimum power setting for a sufficient period to acquire acceptable readings.g.g. if necessary. as may occur during transport. Casters/Mounts/Holders. 4. . lasers powered by three-phase electrical systems may be damaged if proper electrical phase connections are not made initially and maintained thereafter. micromanipulator). With the laser set at low (e. and window coverings are available and being used and that safety interlocks for doors or windows.10 Power Output.2 3. blast shield. activate the laser for a sufficient period to acquire acceptable readings.4 4. (Power meters use different time constants to acquire an acceptable reading. low-power illumination of thermal paper in a chart recorder will create marks on the paper that can be compared to the laser pulse rate. 3. Alternately. Preventive maintenance Verify that all daily preventive maintenance procedures recommended by the manufacturer are carried out. test it in a similar fashion with a power meter of appropriate resolution in the low-power range. exercise great care if the interlocks are to be defeated.

AC Plug. Before returning to use Be sure to return controls to their starting position.4. (Consult National Electrical Manufacturers Association [NEMA] configurations for general-purpose nonlocking and locking connectors if in doubt. Laser Delivery System Calibration.8 4. Or you can calculate it using the following formula: % Transmission = Delivered power × 100% Power entering the fiber 4.3 Labeling. Verify that the plug is acceptable for use with the maximum current and voltage specifications for operating the laser. 4.. handpiece) that the manufacturer indicates can be acceptably calibrated using these procedures. and place a Caution tag in a prominent position so that the next user will be careful to verify control settings. Electrical Wiring Configuration. If the unit includes a Repeat Pulse feature. 4.7 Repeat Pulse.. Use the manufacturer’s recommended calibration procedure to test each new reusable delivery system (e.g. and function before using the unit. Connect the laser to each receptacle and confirm that the laser operates properly. Note the fiber transmission for each delivery system tested if this information is provided by the laser. Power Range.6 Inspection and Preventive Maintenance System ©1995 ECRI.Ho:YAG Surgical Lasers to rest on a shelf. Ensure that the branch circuits and the outlets for the laser are properly wired and rated for use with the laser. medium. test the power output accuracy at several low.5 Delivery systems with less than the manufacturer-recommended transmission (typically >80%) should be returned to the manufacturer. All Rights Reserved. proper neutral and ground connections. and high settings. ensure that it has nonslip legs or supports. but over the full range of available settings. Using the technique described in the Power Output test. specifically confirming that motors are operating in the proper direction. test this feature as described in Item 2. Examine the unit and note the presence. proper phase rotation) has been installed. and content of all labels.g.9 4. 4. Labeling information is typically found in the laser’s operator manual. fiber. location. 9 .) Pulse Duration.4 4. setup. Verify that progressive increases in pulse duration throughout its range of adjustment result in progressively larger burns. Examine the receptacles at each location where the laser is to be used to ensure that the proper electrical configuration (e.

They are among the heaviest and bulkiest pieces of mobile hospital equipment and are often subjected to rough handling. 17:320-46 for additional information on applications and operation of hypo/ hyperthermia units. and lower and stabilize the body temperature of febrile patients. emergency departments Scope: Applies to mobile units that provide both heating and cooling. Circulating-Fluid [17-648] Hypothermia Units [12-078] Hypo/Hyperthermia Units. hyperthermia units. The selected and actual fluid temperatures are displayed. Overview Hypo/hyperthermia units are used primarily to raise the body temperature of victims of accidental hypothermia. does not apply to smaller circulating-fluid pump/heating pad units. The water or antifreeze solutions used in them can corrode interior parts if the units are treated carelessly.) Hypo/hyperthermia units are relatively complex devices. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. hours hours *Flush and refill reservoir.org . Plymouth Meeting. The utility of hypo/hyperthermia units for some of these applications has been questioned. All too often. 009075 414-0595 A NONPROFIT AGENCY 5200 Butler Pike. maintain normal temperature (normothermia) in patients during and after surgery. lower the body temperature for certain surgical procedures. if necessary.Procedure/Checklist 414-0595 Hypo/Hyperthermia Units Used For: Hyperthermia Units. High. PA 19462-1298. patients being heated or cooled by units that use an automatic control mode are not observed as carefully as those whose temperature is being controlled manually. General-Purpose [12-075] Hypo/Hyperthermia Units. operating rooms. Hospital Assessment. Central [12-074] Hypo/Hyperthermia Units. (See Health Devices 1988 Nov. Mobile. The machine senses the actual patient temperature through a rectal. Mobile. skin. The operator selects the temperature of fluid to be delivered to the blanket for heating or cooling the patient. general medical/surgical areas. Heart-Lung Bypass [17-206] Also Called: Hypothermia units. or esophageal temperature probe and delivers heated or cooled fluid accordingly. Type Major Minor ECRI-Recommended Interval 12 months* NA Interval Used By Hospital months months Time Required . The machine displays actual and selected patient and fluid temperatures in this mode. at a six-month interval. heater/cooler units Commonly Used In: Special care units. Hypo/hyperthermia units can typically operate in the following two modes: Manual. heating pads. The operator selects the desired patient temperature. adaptable for devices that provide heat only and for central hypo/hyperthermia units. . which should be inspected using Circulating-Fluid Pumps Procedure/Checklist 412 Risk Level: ECRI Recommended. Automatic (servo). Some units also monitor patient temperature.

(These devices. Exterior screws should be tight. Check the operation of brakes and swivel locks. some clear tubing. Attempt to wiggle the blades to determine that they are secure. if the unit is so equipped. Examine the exterior of the unit for overall condition. All Rights Reserved. be sure that you understand how to operate the equipment. Personnel responsible for inspecting hypo/hyperthermia units who lack the technical expertise to perform this test must recognize their own limitations and seek qualified help. If any damage is suspected. inexpensive antifreeze testers are available from automotive parts suppliers. 17:320-46. and listen for rattles that could indicate loose screws.4) will help ensure that the device has been correctly returned to its proper operating condition. however.2 1.3°C over the range of the hypo/hyperthermia unit’s electronic thermometer. Mount. 1.5 2 Inspection and Preventive Maintenance System ©1995 ECRI. but the water and the thermometer will be required to check temperature probes) Temperature-monitoring device that consists of an accurate dial thermometer to check the temperature of the circulating fluid. as appropriate. if the 1. and the alarm capabilities. We hesitate to recommend such wiring modifications as part of a routine inspection procedure because unskilled personnel may inadvertently damage the unit. accurate and reliable operation of hypo/ hyperthermia units. are available from some hypo/hyperthermia unit manufacturers. the significance of each control and indicator. Qualitative tests 1. is crucial. 1. and appropriate connectors for installing the device in series with the blanket. open the plug and inspect it. If the unit is mounted on a stand or cart. and cups of hot and cold water (a temperature probe simulator suitable for use with the hypo/hyperthermia unit to be inspected may be used instead of the thermometer and the cups of water.3 and 2. check their condition. If the unit moves on casters. Shake the plug. The chassis should be clean and free of rust and corrosion. .) Hydrometer with scales suitable for the type of antifreeze used in the unit (required only if the unit circulates an alcohol or ethylene glycol solution through the blanket). Inspect the cord for signs of damage.3 1. or they can be constructed. Examine the AC power plug for damage. there is no other way to determine whether the backup thermostats are functional.and low-temperature protection tests (Items 2. see User-constructed Test Equipment behind the Test Equipment and Supplies Tab. AC Plug. Citations from Health Devices Hypo/hyperthermia machines and blankets [Evaluation]. Test apparatus and supplies Ground resistance ohmmeter Leakage current meter or electrical safety analyzer Calibration thermometer. Performing the fluid temperature indicator test (Item 2. and be sure that they turn and swivel. Some of the items in this procedure differ from most other procedures in that they may require opening the unit and temporarily modifying the wiring.Inspection and Preventive Maintenance System Thus.4 Special precautions Some units have undertemperature and/or overtemperature protection to avoid damage to the heating element compressor or other parts of the unit.10) after the high. sometimes referred to as shunt thermometers. Casters/Brakes. If damaged. accurate to at least ±0.1 Chassis/Housing. Hypo/hyperthermia units have been implicated in a number of cases of patient injury or death. replace the entire cord or. Short-circuited patient temperature probe plug (required only if the unit has an automatic control mode and circulates an alcohol or ethylene glycol solution through the blanket) Cup of saline solution and strip of aluminum foil for measuring probe leakage current (acceptance testing only) Procedure Before beginning an inspection. Look for accumulations of lint and thread around the casters. Such a device does not normally limit water temperature to a clinically safe level. 1988 Nov. particularly in the automatic mode. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Investigation of these incidents reveals that some could have been avoided with adequate inspection and maintenance. but it should not be deactivated since unit damage can result. Line Cord. carefully read this procedure and the manufacturer’s instruction and service manuals. examine the condition of the mount.

and correct motion. as well as positive stopping. If the unit has a switchtype circuit breaker.. 1. 1. brittle. add a disinfectant according to the manufacturer’s instructions. and check that they are clean and are not cracked. Confirm appropriate volume. cut out the defective portion.1 or 3. confirm the operation of all lights. Check the condition of all tubing and hoses. 1. check the method of reset (e.4 of the inspection form. Tubes/Hoses. Record the settings of those controls that should be returned to their original positions following the inspection. It will not be possible to check out all alarms at this time. Examine the heater for physical condition (e. Confirm that patient temperature probes are on hand. and note this on Line 3. if so equipped. as well as all electrical cable connectors.6 Strain Reliefs. If the unit is protected by an external fuse. and verify proper operation of these components.4. meters. 1. check their positions. 1. 1.. If the unit uses distilled water. If it uses antifreeze.23 Accessories. 1. for general condition.Hypo/Hyperthermia Units damage is near one end. Examine the strain reliefs at both ends of the line cord. check its value and type (as well as those of any spares provided) against that marked on the chassis.18 Indicators/Displays. as well as the operation of the volume control. consider the possibility of inappropriate clinical use or of incipient device failure.3 and 2.2 until you have completed all necessary lubrication).10 Fittings/Connectors. if so equipped. check for proper alignment. Check that all necessary placards. indicators. 1. During the course of the inspection. labels. the hospital should know how many 1. Operate the unit in such a way as to activate each audible and visual alarm. Check that any associated interlocks function. be sure to check that each control and switch performs its proper function.12 Filters. and indicate this on Line 3.g. clean. and instruction cards are present and legible. Be sure that they hold the cord securely. and add fluid as needed.g. and visual displays on the unit and charger. from fingernails or pens). Check the circulating fluid level in the reservoir with a blanket connected. Clean or replace them as needed.16 Fluid Levels. determine the amount of heating. Consult the operator’s manual to determine the proper level. with the fluid at about room temperature. Check the physical condition. add distilled water or the manufacturer’s recommended alcohol-and-water or antifreeze-andwater mixture. that on/off controls function). function properly (e. Lubricate them if required.. If fluid is needed. Examine all fittings and connectors. deteriorated insulation). Check the condition of the fluid filters.14 Heater. corrosion of its sheath. Be sure to wire a new power cord or plug with the correct polarity. Nevertheless. kinked.. Operate the unit to activate any audible signals. 3 . manual or automatic) against the manufacturer’s specifications.g. All Rights Reserved. Before moving any controls or alarm limits. it is not possible to associate the blanket inspection with any one unit.8 1. and bright. During the course of the inspection. gauges. since some of them require abnormal operating conditions that will be simulated later in Items 2. secure mounting. if so equipped. Attach a blanket to each pair of connectors on the unit to ensure that the unit operates smoothly and does not leak. 1. Blankets.2 of the form (but do not check 3. 1. Operate it to verify that its controls Inspection and Preventive Maintenance System ©1995 ECRI.20 Alarms. Be sure that they are not cracked. and general cleanliness. connector operation. If the unit has an alarm-silence feature. Check membrane switches for membrane damage (e. a temperature control that is at the end of its range). 1.g. or dirty. Since blankets do not usually have serial numbers on them and may be interchanged between units.13 Controls/Switches. 1. Examine all controls and switches for physical condition. Electrical contact pins or surfaces should be straight.22 Labeling.7 1.21 Audible Signals. check its specific gravity with a hydrometer.g. conversion charts. Circuit Breaker/Fuse.. Be sure that all segments of a digital display function. that a variable temperature control does. in fact. Check each reusable blanket for leaks. Where a control should operate against fixedlimit stops. or otherwise deteriorated. check that it moves freely.15 Motor/Pump/Fan/Compressor.11 Probes. If any of them appear inordinate (e.

3. Roll. High-Temperature Protection. check the service manual for information on how to do this. Install a jumper across the main thermostat. manual heating. Before performing this test. Record the highest leakage current. and circulate only. and expose the patient temperature probe to room air. Measure the maximum leakage current between the chassis and ground with the ground wire temporarily opened and any redundant ground removed. This test confirms the operation of the high-temperature backup (and secondary backup. except that it confirms the operation of the primary low-temperature backup (and secondary backup. The maximum temperature(s) should agree with the manufacturer’s specification for the primary (and secondary) backup device. Install a jumper across the thermostat. . and expose the patient temperature probe to a value above room ambient temperature. Blankets that pass inspection should be tagged “Inspected. 2. rather than fold. Repeat the test with a shorted patient temperature probe plug substituted for the probe itself. Observe the operation of a Probe Shorted 2. if present) and should be performed only if the unit circulates alcohol or ethylene glycol through the blanket and has an automatic control mode. This test is similar to Item 2. If the device has an accessory outlet. The hypo/ hyperthermia unit should heat the circulating fluid until it is limited by the backup cutoff. If the unit has a secondary low-temperature backup. stored blankets to prolong their life.1 Grounding Resistance. bypass the primary low-temperature backups and repeat the test. the maximum reading of the temperature-monitoring device. it should not exceed 300 µA. Using an ohmmeter. All Rights Reserved. Low-temperature backup cutoffs are intended to protect the patient against excessive cooling if the temperature-control circuitry or probe fails. If the unit has an automatic mode with two backup high-temperature cutoffs. if present) and should be performed on all units regardless of the type of circulating fluid. check its resistance to the chassis. consult the manufacturer to determine how to test backup protection. Check for leaks with the blanket connected to an operating hypo/hyperthermia unit because this produces the highest pressure within the blanket tubing. 2. Set the control temperature to its lowest value. If a redundant ground is provided.5 Ω. Repeat the test with the patient temperature probe unplugged. but should not exceed43°C. and note any alarms.4 Low-Temperature Protection. Operate the hypo/hyperthermia unit in the automatic mode with a temperature-monitoring device connected in series with the input line to the blanket. obtain a schematic of the hypo/hyperthermia unit and determine whether the unit has low-temperature backup protection (a thermostat or other cutoff). manual cooling. and the unit will not operate. Caution: Remove any bypasses installed for this test. electrical safety analyzer. We recommend a maximum of 0. Set the control temperature to room air. Operate the hypo/hyperthermia unit in the automatic mode with a temperature-monitoring device connected in series with the input line to a blanket.2 Leakage Current. some units will indicate the failure with a Probe Open alarm. Identify the backup thermostats or other devices. The temperature should go no higher than before. If the unit has a secondary backup device. Record the lowest temperature indicated by the temperaturemonitoring device. Record 2. Check the following operating modes with the grounding conductor interrupted: off. check both. Quantitative tests 2. Check the service manual for information on how to do this. bypass the primary high-temperature backup and repeat the test. The hypo/hyperthermia unit should cool the circulating fluid until it is limited by the backup cutoff. If the unit does not have an automatic mode.3 4 Inspection and Preventive Maintenance System ©1995 ECRI. or multimeter with good resolution of fractional ohms. either as a second plug or an alligator clip.” with the date and inspector’s initials noted. check its grounding to the main power cord.Inspection and Preventive Maintenance System reusable blankets it owns and should inspect each one regularly. measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. The recorded temperature(s) should agree with the manufacturer’s specification for the primary backup (and secondary backup) device (usually ≥1°C). and note any overheating or hightemperature alarms.

the minimum fluid temperature should be limited by the primary backup cutoff.4 4. and operate the unit in the automatic mode with the temperature-monitoring device in the input line to a blanket and the control point set to 37°C.10. is more convenient for determining the accuracy of the patient temperature indicator. If the machine operates at all. perform the following tests. Record the two readings on the form. 3. Repeat this test with each probe. All Rights Reserved. probe accuracy must also be verified. 3. if so equipped. The circulating fluid temperature should equilibrate at the high value recorded in Item 2. Lubricate the circulating pump. Leakage current greater than 100 µA suggests a damaged probe. it should not drop below 1°C. if needed. The temperature of the circulating fluid should drop to the low level recorded in Item 2. and wait until the temperature stabilizes (this should take 3 to 10 min). The first two should be within 1°C of the temperature-monitoring device. Repeat this test with the manual control set at its highest temperature. Note the reading on the patient temperature indicator when the unit switches from cooling to heating. as measured with the calibration thermometer. listen for a change in sound as the cooling compressor stops.1 Clean the exterior. This test can also be performed using a patient temperature probe simulator. The temperatures. 2. If the unit lacks indicators for the heating and cooling modes. if available. the reading of the fluid temperature indicator.1 Probe Leakage Current. in all cases. because the simulator tests only the circuitry and not the probe itself. Caution: Remove any bypasses installed for this test. This test applies only to units with an automatic mode. However. Operate the unit in the manual mode with the temperature-monitoring device in the input line to the blanket. allow them to equilibrate. interior. and fluid filter. Save the warmest and coldest cups of water for the next test. it should not exceed 43°C. measure leakage current from all available probes in every operating mode.12 Automatic Controller Switching. In addition.3 3. and successively plug each into the same pretested temperature unit or module. This will usually require removal of a chassis panel. should be within 1°C.5°C of the 37°C set-point temperature. This test applies only to units with an automatic mode of operation. A convenient test method is to dip all probes simultaneously into one bodytemperature water bath. Preventive maintenance 3. Next. measure probe circuit leakage current directly from each probe electrical lead contact (using an appropriate plug) on units that Inspection and Preventive Maintenance System ©1995 ECRI. Alternatively. if required. 2. Place the calibration thermometer and the unit’s patient temperature probe in the water near each other.) Repeat the test with cups of water at temperatures of about 37°C and 41°C. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. Calibrate.) 2.10. transfer the patient temperature probe to the cup of cooler water saved from the previous test (it is not necessary to recheck the temperature of that water).Hypo/Hyperthermia Units alarm. If the unit has a patient temperature probe. if necessary. Remove dirt that has accumulated in vents and cooling fans within the unit with a vacuum cleaner or compressed air hose. clip the lead from the leakage current meter to the foil. if necessary.10 Fluid Temperature Indicator.11 Patient Temperature Indicator and Probe. Keep the patient temperature probe immersed in the cup of 41°C water used in the last test. Fill a cup with tap water at about 30°C. and observe both the temperature indicator and the Heat and Cool indicators (if so equipped) on the unit. A patient temperature probe simulator. (Some variation is normal because the water temperature varies slightly with location in the bath and the water gradually cools with time. 5 . Select the lowest blanket temperature setting.2 3. It should be within 0. All probes should give the same temperature reading. Record the setting of the control knob. and immerse the probe and foil in a salt water solution (normal saline or about a teaspoon of table salt per cup of water). Flush/refill the reservoir and replace the fluid filter. (It may be necessary to operate the unit in order to read the thermometer. and the reading of the temperature-monitoring device. if available. 4. Be sure that the thermometer is immersed to an adequate depth to provide an accurate reading. Wrap the probe loosely with aluminum foil.

set the water temperature selector to its highest setting. This test will determine the difference between the set-point temperature and the reset temperature of the high-temperature thermostat. Connect a blanket and/or test hose shunt to the unit. All Rights Reserved.Inspection and Preventive Maintenance System do not use ground-referenced probe circuits. thoroughly examine the probe for defects (Item 1. Watch the water temperature indicator and the Heat light. After warm-up. The Heat light should come on.) Allow the unit to warm up for at least 15 min in the manual mode with the water temperature set to 40°C. This is the setpoint temperature of the primary high-temperature thermostat. and record the temperature at which the Heat light comes back on. Thus. (Some units require that fluid circulate while the unit is operating. Allow the unit to continue running in the manual mode with the water temperature selector set to its highest setting. . Observe the water temperature indicator. If a problem is found in this mode.) However. this is the reset temperature of the thermostat. (An appropriate resistance to simulate the thermistor may be required on some units that have protective circuits to turn off heater power in the event of a probe malfunction.11).2 Hysteresis. Before returning to use Verify that any control circuits that were bypassed or deactivated for testing purposes have been returned to their normal operating conditions. This temperature should agree with the manufacturer’s specification. If the leakage current to ground from each lead of the connector is less than 100 µA in each operating mode. and record the water temperature reading at which the Heat light goes out. The difference between the set-point temperature and the reset temperature is the hysteresis. This test need be performed only in the manual mode. then it is unnecessary to check leakage current from the probe itself. The maximum hysteresis should be 3°C. The water temperature will begin to slowly drop. 6 Inspection and Preventive Maintenance System ©1995 ECRI. the reset temperature range will typically be 39° to 41°C. indicating that the water is being warmed. 4. it would consequently also be present in the automatic mode.

Transport incubators are both portable and mobile. Most incubators warm the infant by a forced or natural flow of heated air. Mobile [17-432] Incubators. Infant incubators [Evaluation]. and poor transport incubator performance or power failure due to improperly maintained batteries or unreliable battery-charge-level indicators. and may be required to operate in ambient conditions much colder than those found in a hospital. 16:376-7. no longer in production. and rest on relatively high movable stands. and aircraft Scope: Does not apply to radiant warmers or transport radiant warmers (see Procedure/Checklist 419) Risk Level: ECRI Recommended. have stands that are relatively low or adjustable in height to fit into vehicles with restricted overhead clearance. 1987 Nov. Air-Shields Vickers C100 and C200 infant incubators [Hazard]. and TI-100 infant incubators [Hazard]. One type. they routinely receive rough handling (especially transport units) that may degrade performance and physical condition. PA 19462-1298. ambulances. Transport [12-114] Commonly Used In: Delivery rooms. 15:212-3. Deaths and injuries to neonates have occurred in incubators. Air-Shields C-86. Transport incubators provide thermal support during transfer within the hospital or by car. C-100.Procedure/Checklist 415-0595 Infant Incubators Used For: Incubators. Infant incubators are designed primarily for in-hospital use at specific locations. Air-Shields C-300-1. 009078 415-0595 A NONPROFIT AGENCY 5200 Butler Pike. 11:301.org . Reports include thermostat failures that caused incubator overheating and infant hyperthermia. including self-contained batteries. C300-2. Overview Infant and transport incubators provide warmth to help an infant maintain a normal body temperature and are often essential for an infant’s survival. 1981 Dec. Update: Transport incubators. ambulance. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. 1982 May. nurseries. or aircraft to another hospital. neonatal ICUs. . and C-200 infant incubators [Hazard]. 1982 May. Periodic inspection may reveal hazardous deficiencies that could harm patients. supplements air convection with radiant infrared energy from heated bassinet and hood walls. 11: 179-91. 1986 Jul. operate from a variety of power sources. hours hours * Minor intervals for transport incubators should be every 3 months. Type Major Minor ECRI-Recommended Interval 12 months NA* Interval Used By Hospital months months Time Required . 16:253-4. Because incubators are bulky and mobile. 11:65-8. Citations from Health Devices Mercury contamination in incubators and elsewhere. operate on AC line power in a temperature-controlled indoor environment. Infant. 11:191-9. Transport incubators [Evaluation]. Hospital Assessment. malfunctions or design defects that produced fires and presented electrical shock hazards. Plymouth Meeting. 1982 Sep. Infant. 1987 Jul. High.

1 Chassis/Housing. Sometimes a loose screw may not be easy to detect visually. ECRI recommends replacing all mercury-containing components in infant incubators. Check that all screws. a temperature simulator will simplify some device tests. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. The hood condition is important for proper control of the infant’s environment.. Examine the overall exterior condition of the chassis. All Rights Reserved. and that no adhesive tape or tape residue is present. Do not allow mercury to contact an open cut. Check that the control unit is clean. bed. Look for contamination of the air supply and blocked air and/or humidity passages caused by improper placement of the humidity tray or gaskets.1°C in the clinical range Oxygen source and flowmeter Hot-air gun or hair dryer For transport incubators with lead-acid batteries: hydrometer to measure specific gravity of the batteries. 11:65 and the “IPM Safety” article behind the Guidance Tab in this binder). 1994 Oct-Nov. or other signs of deterioration. remove the hood. and fasteners are tight. and the alarm capabilities. warping. 17:314-5. Examine the humidity apparatus for deterioration. 19:245.001 accuracy (available from any scientific apparatus supplier) (Note: automotive hydrometers that indicate only GOOD or BAD without numerical specific gravity indications are not suitable. the significance of each control and indicator.g. Examine all ports for proper alignment and sealing. nuts. Thermometer holders detaching from hoods of Ohmeda Air-Vac transport incubators. Remove any tape. or misassembly of internal components that could interfere with performance. If it is necessary to inspect several incubators that have patient probes. It may be necessary to use different connectors to accommodate the probes of the incubators being inspected. Test apparatus and supplies Ground resistance ohmmeter Leakage current meter or electrical safety analyzer Patient-probe simulator capable of simulating a range of temperatures as well as open. and missing or incorrectly assembled parts. and other parts and thoroughly inspect the interior for foreign objects. float markings should cover the range from 1.) 1. If an incubator to be inspected is in use. main deck.2 Mount/Fasteners. but at least one cup of water will be needed to verify probe accuracy and probe leakage current Calibrated glass or electronic thermometer accurate to within 0. Determine whether any parts are missing or incorrectly assembled. carefully read this procedure and the manufacturer’s instruction and service manuals.and shortcircuited probe conditions (for incubators that use patient temperature probes) Plastic 6 to 8 oz cup Source of varied-temperature water.280 to within 0. deterioration. 23:457-8. Special precautions Examine all mercury-in-glass thermometers and high-temperature thermostats. 1990 Jul. baffle. Procedure Before beginning an inspection. Qualitative tests 1. replace and clean the unit carefully using appropriate precautions for mercury spills (see Health Devices 1981 Dec. 1.240 to 1. Mallinckrodt incuTemp 4 skin temperature probes and Air-Shields Vickers C-100 incubators [Hazard]. contamination. .Inspection and Preventive Maintenance System Air-Shields Vickers C-86 infant incubators [Hazard]. The procedure is essentially the same as that used in Temperature Monitors Procedure/Checklist 425. Check all rubber or plastic gaskets in the incubator for signs of deterioration (e. 1988 Oct. ask clinical personnel if they can use a temporary substitute. it may be convenient to use a patient-probe simulator to test indicator accuracy and temperature control effectiveness of all probes simultaneously. Ensure that the hood is free of cracks. operate the equipment. Use a screwdriver and systematically try to tighten every screw on the hood. cracks). CAUTION: Mercury and its vapors are toxic. be sure that you understand how to 2 Inspection and Preventive Maintenance System ©1995 ECRI. that all labels and markings are legible. or request that they notify you when the incubator is free for inspection. If broken. Consult the instruction manual for a general exploded diagram of the incubator.

. Examine all controls and switches for physical condition. from fingernails. electrode. During the course of the inspection. All Rights Reserved. 1. as appropriate..12 Filters. since they will be routinely replaced when the interior is sterilized for the next incubator application. or otherwise deteriorated. A torn or otherwise damaged iris reduces the integrity of the closedchamber system. or dirty. Be sure to wire a new power cord or plug with the same polarity as the old one. where appropriate. You need not replace torn disposable irises. Remove accumulations of lint and thread from around the casters. 1. If any damage is suspected. check their condition. and record the date you install a new filter. replace the entire cord or. Attempt to wiggle the blades to determine that they are secure. Examine the AC power plug for damage. Inspect the cord for signs of damage. Examine all patient probes to ensure that they are clean and are not cracked.g. Change filters regularly according to the manufacturer’s recommendations. insert an AC plug into each and check that it is held firmly. If the device is protected by an external fuse. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors of each end to prevent rotation or other strain. Check line cords of battery chargers. Strain Reliefs. Verify with clinical personnel that this practice is enforced and that disposable irises are not reused. Inspect the air filter for signs of clogging. Inspect all oxygen orifices to make sure that they are clear and free of foreign matter. Be sure that they are not cracked. If any of them appear inordinate (e.7 1. 3 . consider the possibility of inappropriate clinical use or incipient device failure. 1. replace it and note this on Line 3. Improperly interchanged probes of different types or from different manufacturers may adversely affect temperature control. check for proper alignment. Record the settings of those controls that should be returned to their original positions following the inspection.13 Controls/Switches. Check membrane switches for membrane damage (e. ensure that probe labels clearly identify the associated units. Examine the iris diaphragms and port sleeves for tears. 1. as well as positive stopping. If damaged.3 Casters/Brakes. and bright. check that it operates freely.10 Fittings/Connectors. If the hospital has more than one type of infant incubator. and correct motion. consider a full inspection of the receptacle. If accessories are plugged and unplugged often. sensor. 1. Before moving any controls and alarm limits. 1. Clogged or improperly installed filters can raise the oxygen concentration above safe levels.6 1.5 Line Cord. Check the condition of all tubing and hoses.9 Cables.4 1. Tubes/Hoses. 1. Check the operation of brakes and swivel locks if the unit is so equipped. a temperature control turned to the end of its range). Where a control should operate against fixedlimit stops. AC Plug/Receptacles.4 of the inspection form. pens). remote control) and their strain reliefs for general condition. Be sure that they hold the cord securely.8 Inspection and Preventive Maintenance System ©1995 ECRI. If the device has electrical receptacles for accessories. open the plug and inspect it. Vary the oxygen flow and check that manufacturer-specified maximum and minimum flow rates can be achieved. Conductivity checks. and be sure that they turn and swivel. Consult the manual to determine if the irises are disposable types that should be discarded after each incubator use. Circuit Breaker/Fuse. check its value and type against that marked on the chassis. Shake the plug and listen for rattles that could indicate loose screws. Inspect the cables (e. Examine the strain reliefs at both ends of the line cord. if the damage is near one end.g.Infant Incubators Operate iris-type port closures to ensure proper function. be 1. and ensure that a spare is provided. Check the air-filter assembly to ensure that airflow is unimpeded. if the filter looks dirty. cut out the defective portion.11 Probes. Electrical contact pins or surfaces should be straight. brittle. Attach an oxygen source with a flowmeter to each oxygen port and use your hand to feel that gas is flowing into the chamber. kinked. are usually done more efficiently as part of a check of all equipment and furniture in an area. clean. Examine all electrical cable connectors for general condition. If the device moves on casters.. secure mounting. If the device has a circuit breaker.g. check their positions.

Check for obstructions in the vent caps and associated venting system. label it with the date. Operate the device to activate any audible signals. In some cases.19 User Calibration/Self Test. Each battery should have an identification number and an accurate log of operating time. darkening. or replace the charging circuit if it appears corroded. spin the fan with your finger (with the power off) and make sure that it turns smoothly. If possible. meters. cycle the heater off and on as the set point is varied). 1. Inspect the fan blades for deterioration or damage. Check that any associated interlocks function. 1. they 4 Inspection and Preventive Maintenance System ©1995 ECRI. test these with open. including those in lead-acid batteries. an improperly inserted control module and heater assembly in the incubator base has bent and disabled the fan. Check the action of the disconnected-probe alarm. 1. Disassemble the heating unit enough to expose the heating element. and connectors. Examine the element for severe discoloration or foreign deposits. If the device has an alarm-silence feature. Operate the unit on battery power for several minutes to check that the battery is charged and can hold a charge. A liquid-electrolyte lead-acid battery located in the same case as the charging circuitry can cause problems unless the battery is kept clean. In some incubators. if so equipped. Check that labels clearly and concisely identify the functions of all controls. Check that clearance between the fan and its housing is adequate by looking for signs of rubbing. in fact. where applicable. Confirm appropriate volume. recharges. check that they are tight. distinct surface spotting may indicate that material has come into contact with the element.g. 1. 1. preventing air circulation and causing overheating.20 Alarms. Inspect the physical condition of batteries and battery connectors if readily accessible.15 Motor/Fan. such as melting (if plastic). Because incubators may administer supplemental oxygen.16 Fluid Levels. charge the battery. if it has alarms for open. If you find such discoloration. All Rights Reserved. or lost blades. Heating elements normally change color with use. in fact. and watch for wobbling or excessive vibration.22 Labeling. and inspections to permit early detection of deteriorating performance. confirm that it does. Operate the heater to verify that heater controls function properly (e.18 Indicators/Displays. 1. manual or automatic) against the manufacturer’s specifications. Check operation of battery-operated power-loss alarms if so equipped. Check the service manual to determine if the fan motor requires lubrication. If there is electrolyte or a yellow-white powder on the battery. Ensure that the fan is securely attached to its drive shaft and that the coupling is present and intact.e. Verify operation of these features. switches. indicators. check the method of reset (i. When it is necessary to replace a battery.and shortcircuited probe plugs. If necessary.. Verify that all segments of a digital display function. Wipe components clean. If screw terminals connect the heating element to the control circuitry. 1. or blow out the tubes through a straw inserted into the vent hole.g. . Check all fluid levels. confirm the operation of all lights.17 Battery/Charger. During the course of the inspection. Check the sound level inside the incubator. Oil as recommended and note on Line 3. service. blistering). that a variable temperature control does. but dark. warping.Inspection and Preventive Maintenance System sure to check that each control and switch performs its proper function. possibly after falling through the air duct. expose the fan and operate it. if the unit is so equipped. check for contaminating deposits on components of the charging circuit. 1. Foreign matter touching the hot surface could cause a fire or the generation of noxious fumes.2 of the inspection form.. the fan is visible at the back of the control module if the module is removed. 1. and visual displays on the unit and charger. Check remaining battery capacity by activating the battery test function. Operate the device in such a way as to activate each audible and visual alarm. these may cause rapid deterioration. examine the control unit compartment for signs of overheating (e. clear the venting system with a stiff wire. Wash off acid and other materials that may collect on top of the battery.or short-circuited patient temperature probes. Also. and to the extent possible. noisy operation may indicate that the fan motor or housing assembly needs service. Check the condition of the battery charger. as well as operation of volume controls.14 Heater. gauges.. If possible.21 Audible Signals.

use the following methods. set the temperature control to mid range. Mattress. and record the hood thermometer reading and the true mid-hood air temperature in Item 2. it might be possible to consolidate it by removing the thermometer and carefully dipping it in hot water. measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. In either case. The pressure may eliminate the column separation. incubator labeling should also include the following: WARNING: EXPOSING INFANTS TO ELEVATED OXYGEN CONCENTRATIONS MAY CAUSE BLINDNESS. the primary thermostat cycles the heater on and off or provides proportional heating to maintain a constant hood temperature. We recommend a maximum of 0. Chassis leakage should not exceed 300 µA. 5 . 1.5 Ω. If the unit is to be used in the presence of flammable anesthetics. but it may also break the thermometer. check its grounding to the main power cord. Then. If the system is modular. 2. which test both manual and automatic temperature controls. Repeat the process if necessary. In the automatic mode. check the ease of motion and security of the locking mechanism. If the manufacturer does not provide instructions. Thus.23 Accessories. and during battery operation.g. overheating the thermometer may break it. from the charger chassis in all operating modes. examining and phototherapy lamps) are operating.1 Grounding Resistance. check that a conductive mattress cover is being used. as well as equipment plugged into a multiple-outlet strip (“Waber strip”). Quantitative tests 2. If the device has an accessory outlet. since proper thermostatic operation depends on the presence of normal airflow patterns. If the primary thermostat 2. The operator can adjust the temperature by changing a setting. cool the thermometer and recheck it for column separations. Inspection and Preventive Maintenance System ©1995 ECRI. Test the thermostats according to the manufacturer’s instructions.3 Temperature Control. Even with a reserve space. and electronic circuits control the heater to keep the skin temperature constant at a clinically desirable level. close the hood. Measure while all accessories (e. If the thermometer has an expanded space at the top. position the calibrated glass or electronic thermometer 10 cm (4 in) above the center of the mattress. In the manual mode. (Note that the chassis leakage of transport incubators may vary with the state of battery charge. When the gap in the column disappears into the pool. it is essential. Replace the thermometer if it is cracked.) Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off.. This includes other equipment that is plugged into the primary device’s accessory receptacles. the heated liquid will expand until it completely fills the thermometer. verify grounding of the mainframe and each module.7. All Rights Reserved.2 Leakage Current. If the mattress position is adjustable. including off. Although this is time-consuming. Exposing an infant to high oxygen concentrations may cause retrolental fibroplasia and possible blindness. or multimeter with good resolution of fractional ohms. Check the action of the primary and safety thermostats with the incubator fully assembled. alternately raise and lower the temperature setting. Using an ohmmeter. oils. 2. Hood thermometer. Examine the mattress for cleanliness. Check the hood thermometer for cracked glass and separation of the liquid column. since textiles. If the liquid column has separated. do not heat the thermometer too fast or to too high a temperature while attempting to consolidate the column. electrical safety analyzer. if the unit has a battery charger. a patient probe senses the infant’s skin temperature. and record on the form the temperature at which the safety or backup thermostat turns off the heater. Measure the leakage current to ground from the incubator chassis and. allow the incubator to warm up to thermal equilibrium. after which pressure will build up. the liquid will pool in the small reserve chamber. so that all are grounded through a single line or extension cord.Infant Incubators should carry a WARNING — FIRE HAZARD placard. and other combustibles ignite easily and burn intensely in oxygenenriched air. To test manual controls. If the thermometer does not have reserve space at the top.

and verify that the low skin-temperature alarm activates. 2. and record the patient-probe temperature indication and the true bath temperature in Item 2. should agree within 0.3°C. deliver intermittent bursts of heat and pause for thermal stabilization.3°C. To verify the high skin-temperature alarm. allow the temperature readings to stabilize. Also. and associated wiring and connectors.3 should agree within 1°C. Stir to reduce temperature gradients. Reconnect the primary thermostat that had been disabled in the above procedure (consult the operator’s manual to determine the necessary procedure). The portable power supply usually consists of a rechargeable battery. Place the probe and a calibrated thermometer into a cup of water preheated to approximately 35°C. avoid blowing hot air directly at the thermometers. Verify that the low air-temperature alarm (if so equipped) activates when the incubator hood is opened. verify that the alarms are functional. downstream in the airflow. and repeat the test. or the mid-hood air temperature at the alarm point will be erroneously high. set the air-temperature set point to 36°C and slowly increase the air temperature with an external heat source (e. Battery types vary.g. first test the accuracy of the patient-probe temperature indicator.8 2. Confirm the operation of the temperature control circuit by alternately dipping the probe into cold and hot water. so that its temperature lags behind the mid-hood air temperature. Adjust the skin temperature set point to 36°C. The mid-hood air temperature and hood thermometer readings taken in Item 2. Adjust the air-temperature set point to 36°C and allow the air temperature to stabilize. the measuring circuit or meter is defective and requires recalibration or repair. and each requires a different inspection and preventive maintenance procedure.4 Skin-Temperature Alarms. verify that these alarms function. and alkaline batteries. If the battery is charging at 2. The patient-probe temperature indication and true water bath temperature. All Rights Reserved. To verify the high air-temperature alarm. place the sensor in a water bath set at 36°C and gradually increase the water bath temperature. a recharging circuit. If the two readings still disagree. It is essential to keep all parts in good condition to ensure the safe. To check automatic controls. Portable Power Supply (transport incubators only).. 2. . Record the hood thermometer indication and the true mid-hood air temperature at which the safety thermostat and high-temperature alarm respond.9 6 Inspection and Preventive Maintenance System ©1995 ECRI. Note the point at which the high alarm responds. disable the primary thermostat or disconnect it from the control circuit (consult the manual to determine the necessary procedure) so that the heater remains on continuously. hair dryer or heat gun). The heater should activate when the probe is cold and turn off when the probe is hot. the probe may be defective. the heater will turn on and off.7 Hood Air Temperature. This is because the safety thermostat is often at some distance from the mid-hood area. 2. If a blower is used. Types commonly used are lead-acid with a liquid or sealed gelled-electrolyte. Remove the sensor from the incubator. but not while the battery is charging. Measure the specific gravity of lead-acid batteries with a hydrometer. respectively. It is possible to speed up the air-temperature rise by supplementing the incubator heater output with a hot-air gun or hair dryer. Substitute a probe known to be accurate.5 Safety Thermostat To test the operation of the safety thermostat and the high-temperature alarm. also recorded during performance of Item 2. In some cases.3.6 Air-Temperature Alarms. If the two readings do not agree within 0. Sealed batteries require less maintenance than types to which fluid must occasionally be added to compensate for evaporation. well below and above the skin-temperature set point. If the incubator is equipped with high and low air-temperature alarms other than those that are controlled by a secondary temperature controller. this can be achieved by turning the temperature control to its maximum setting. 2.Inspection and Preventive Maintenance System is operating properly. Be careful not to heat the hood air too rapidly with the hot-air blower. Place the sensor in the incubator and allow the temperature to stabilize. Note when the high alarm responds. respectively. Patient Probe.8. effective operation of the transport incubator. If the incubator is equipped with high and low skin-temperature alarms. nickel-cadmium.

) If the liquid level is low. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. Before returning to use Set all controls to their normal positions. (It may be necessary to check the electrolyte level and measure the specific gravity of lead-acid batteries as frequently as every two weeks. turn the heater on after the batteries are fully charged. 3. All Rights Reserved. taking care to avoid splashing or spilling. The specific gravity of a fully charged battery should be 1. 4. rapidly fill and empty the hydrometer several times to thoroughly mix the electrolyte. If the battery has been on a constant trickle charge and the specific gravity is too low and battery voltage is lower than 12. add distilled or demineralized water to bring the level to the split ring in each cell. Replace filter and battery if needed. If the voltage decreases more than 10% during this period. Lubricate the fan assembly if required.2 3. Preventive maintenance 3. The charging circuit may need readjustment.4 Clean the exterior and interior.1 3.Infant Incubators inspection time.3 3. Before taking a reading. depending on use and age of battery. If the incubator uses nickel-cadmium or gelled-electrolyte lead-acid batteries.6 V. Calibrate if needed. then the battery is defective or the charger circuit is at fault. and measure the voltage under load initially and after 15 min of operation. disconnect the charger and wait at least 15 min before testing the battery. Do not overfill. Record the two values. 7 . replace the battery. Excess water may boil over and damage the battery case and nearby charging circuits.265. Inspection and Preventive Maintenance System ©1995 ECRI.

Syringe [13-217] Pumps. They are commonly used to infuse antibiotics. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. and maximum dose. 1984 Nov. Hospital Assessment. High. Patient-Controlled Analgesic [16-924] Infusion Pumps. Microinfusion pumps are similar to general-purpose pumps but have greater flow resolution and lower flow settings. 15:182-4. analgesics. Enteral Feeding [13-209] Commonly Used In: All patient care areas.Procedure/Checklist 416-0595 Infusion Devices Used For: Infusion Controllers [11-010] Infusion Pumps. Most general-purpose infusion pumps have a flow range of 1 to 999 mL/hr. 1987 Jan. Enteral feeding pumps are typically used to deliver enteral solution or food mixtures to a patient’s stomach or small intestine through an enteral feeding tube. Syringe infusion pumps [Evaluation]. PA 19462-1298. they are commonly used in neonatal critical care areas. Syringe pumps are typically used to infuse small volumes at rates less than 100 mL/hr by depressing the plunger or sliding the barrel of a conventional syringe installed in the pump. Citations from Health Devices Enteral feeding pumps [Evaluation]. 13:9-30. lockout interval. 1985 May. patient-controlled analgesic (PCA) pumps. chemotherapeutic agents. they are programmed for drug concentration and dose volume. microinfusion pumps. Generalpurpose infusion pumps and controllers are used for many of the same applications and have similar alarm features. General-Purpose [13-215] Infusion Pumps. while most controllers regulate flow in a range of 3 to 300 mL/hr. Undetected upstream occlusions in volumetric infusion pumps [Hazard]. . Multichannel [17-634] Infusion Pumps.org . Plymouth Meeting. Infusion controllers [Evaluation]. 16:3-32. syringe pumps. Ambulatory [16-491] Infusion Pumps. infusion controllers Risk Level: ECRI Recommended. Multichannel infusion devices consist of two or more general-purpose pumps and/or controllers within one chassis. 009060 416-0595 A NONPROFIT AGENCY 5200 Butler Pike. However. enteral feeding pumps. infusion pumps infuse under pressure. ambulatory pumps. PCA pumps deliver pain medication on patient demand by handswitch activation. and total parenteral nutrition solutions. Micro [16-722] Infusion Pumps. 1986 Jun. whereas controllers regulate a gravity infusion. Ambulatory pumps are small and do not rely on line power or gravity for operation. hours hours Overview Infusion devices are often used when accurate delivery rates are required over long periods of time. multichannel pumps. 14:219-56. including general-purpose infusion pumps. homes Scope: Applies to most types of electromechanical devices that regulate the delivery of fluids to a patient. Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required .

AC Plug/Receptacles. cassette. 1991 Sep. or 10 mL pipette with 0. if the damage is near one end. if the unit is so equipped. syringe. carefully read this procedure and the manufacturer’s instruction and service manuals. open the plug and inspect it. Mount. Ambulatory infusion pumps [Evaluation]. 18:92-133. Circuit Breaker/Fuse. 1. check their condition. 16:351-76. or cart that moves on casters. or cart..1 mL graduations and vertical mounting stand 1.2 1. check its value and type against that marked on the chassis. and ensure that a spare fuse is provided. Check that labels and markings are legible. examine the condition of the mount. Examine cables carefully to detect breaks in the Test apparatus and supplies General: Ground resistance ohmmeter Leakage current meter or electrical safety analyzer At least one IV tubing set. 21:323-8. or Infusion pump analyzer For determining flow accuracy at settings <1 mL/hr: Electronic balance with a 200 g range and resolution to 0. 1987 Nov. If the unit is mounted on a dedicated IV pole. Screws and brackets that attach the unit to an IV pole should be secure and functioning.5 Line Cord. IV free-flow — still a cause for alarm [Perspectives]. Examine the unit for overall condition. clinically unusable) IV solution or degassed water IV pole Pressure meter (0 to 50 psi) U-100 insulin syringe and needle For determining flow accuracy at settings ≥1 mL/hr: 50 mL graduated cylinder with 1 mL graduations and stopwatch or watch with a second hand. If the unit has a switchtype circuit breaker. Examine the strain reliefs at both ends of the line cord. pressure sensing mechanisms. 1989 Mar-Apr.3 1. consider a full inspection of the receptacle. Also examine the pole. Be sure that they hold the cord securely. 1988 May.1 mg and small beaker. the significance of each control and indicator. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Inspect drop sensors and remote air-inline detector cables for general condition. ECRI responds to FDA Public Health Advisory on IV free-flow [Hazard]. pump or controller mechanisms). All Rights Reserved. Qualitative tests 1. be sure that you understand how to operate the equipment. Check the operation of brakes and swivel locks. especially near moving parts (e. stand.e. If the device or its IV pole has electrical receptacles for accessories. Attempt to wiggle the blades to determine that they are secure. Be sure to wire the new power cord or plug with the correct polarity.7 1. . inspect them by inserting an AC plug into each and checking that it is held firmly. cut out the defective portion. Casters/Brakes.. 17:137-66. thumbwheel switches. 1.4 1. Also check for dried solution deposits on accessible air-in-line sensors. Shake the plug and listen for rattles that could indicate loose screws. Inspect the cord for signs of damage. 20:324-58.Inspection and Preventive Maintenance System Ambulatory insulin infusion pumps [Evaluation]. check that it moves freely. If any damage is suspected. If accessories are plugged and unplugged often. The chassis should be clean and free from IV or enteral solution residue. 1994 Jun. 23:256-7. either replace the entire cord or. 1. and infusion set/cassette locking mechanisms. Examine the AC power plug for damage.6 Procedure Before beginning an inspection. If damaged. Patient-controlled analgesic pumps [Evaluation]. If the device is mounted on a stand or cart.9 2 Inspection and Preventive Maintenance System ©1995 ECRI. stand. General-purpose infusion pumps [Evaluation]. 1992 Sep.1 Chassis/Housing. and the alarm capabilities. Look for accumulations of lint and thread around the casters and be sure that they turn and swivel. Strain Reliefs. If the unit is protected by an external fuse.g. and/or other disposable specified for the pump or controller being inspected Fluid container of outdated (i. as appropriate. Cables.

11. turning the fluid container upright will cut off the supply.10 Fittings/Connectors. Before moving any control switches. connect the cable.g. Test its function by introducing a small air bubble into the system by righting the fluid container briefly or by injecting air into an injection port of the IV tubing with a syringe between the container and the air-in-line detector. 50 and 100 µL volumes can be approximated by 5 and 10 units. and operate the pump at a high-flow setting. and correct motion. Set up the infusion device according to the manufacturer’s instructions. drop sensor. Air-in-line. If any appear inordinate (e. Ensure that they are gripped securely in the connectors at each end to prevent rotation or other strain. Many of the alarm capabilities of infusion pumps and controllers can be checked qualitatively. as well as the operation of any volume control. occlusion pressure limits) that should be returned to their original positions following the inspection. dials. indicators. check for proper alignment. using an IV pole. See Item 2.g. Check this alarm during setup and operation. (Sensitivity to air volumes of less than 50 µL is likely to result in nuisance alarms. this alarm is the same as the empty-container alarm. as well as positive stopping. This requires a special cable that connects the pump to the nurse-call system. nurse call) for general condition.18 Indicators/Displays.g. During the course of the inspection. Check the instruction manual to see how the alarm should work.) Empty container. Where a control should operate against fixedlimit stops. and display backlighting.g.g. When it is necessary to replace a battery. respectively. Operate the unit on battery power during its entire inspection to check that the battery has been charged and can hold a charge. pens). confirm the operation of all lights. a container of outdated IV solution or degassed water. or knobs. Examine any electrical cable connectors (e. Infusion complete. volume-infused counter or audible alarm level at the end of its range). <5 mL/hr). Be sure that all segments of a digital display function. set it to a low volume (e. Inspect the physical condition of batteries and battery connectors. 3 . if so equipped. Check membrane switches for membrane damage (e. meters. visual displays. from a U-100 insulin syringe. Simulate an empty fluid container while the device is infusing. 1. All Rights Reserved. Some pumps have a relay contact closure that activates a nurse-call system when an alarm condition occurs. and simulate one or Inspection and Preventive Maintenance System ©1995 ECRI. During the course of the inspection. 10 mL). (Many infusion devices automatically check indicator and display function when turned on or during a manually activated self-test.. Open door/misloaded infusion set.17 Battery. and the specified IV set. Fully charge the battery before returning the unit to use. Examine all controls and switches for physical condition. Confirm appropriate alarm volume. For most units. check to ensure that it is properly displayed and then continue the inspection using line power. secure mounting. most devices will trigger an alarm for greater than 100 µL air.20 Alarms.. 1. Nurse call. consider the possibility of inappropriate clinical use or of incipient device failure.. be sure to check that each control and switch performs its proper function. Be sure that the set is properly primed and that bubbles are removed. In some units. simply remove the sensor detector from the drop chamber. Check any spill-protection connector caps for signs of damage.. label it with the date. and trigger the alarm.. if readily accessible. When an alarm occurs. 1. If a low-battery alarm occurs.) 1.. check their positions. Note how long the unit has been operating and the conditions under which the low-battery alarm occurred. Record the settings of those controls (e. from fingernails. Occlusion. empty the tubing leading from the container. Electrical contact pins or surfaces should be straight and clean. For units that rely on a drop sensor or an empty container detector to determine fluid depletion. If the unit has this capability and it is used in any clinical location. gauges.Infusion Devices insulation.g.13 Controls/Switches. check to see that both audible and visual alarms are activated and that flow stops or is reduced to a keep-vein-open rate (e. The following procedures include tests for the most common alarm conditions. If the total volume to be infused can be preset. The simulation method will depend on the type of sensor that is used in the alarm system. 1.

Measure leakage current between the chassis and ground with the grounding conductor temporarily opened. for pumps programmed in mass units (e. Flow settings <1 mL/hr: If an electronic balance is available.0 mg/mL and a 1. (This test applies only to PCA pumps. as well as the operation of the volume control.5 mL boluses.25 Lockout Interval. 1. 2.g. solution used. Flow settings ≥1 mL/hr: Use an infusion pump analyzer or collect the output in a graduated cylinder.g. press rate switches) to activate any audible signals. Convert the mass to volume (1 g H2O = 1 mL. mL). 2. normal saline]. Activate a dose. 2. labels.g. conversion charts.1 mL/hr). Divide the calculated volume by the collection time in hours (e. pump chamber or syringe brand and size (where user selectable). or multimeter with good resolution of fractional ohms. check its grounding to the main power cord. select a concentration of 1. Record the time interval and volume collected. and then verify that a second dose cannot be activated until the programmed lockout time has elapsed.. 1.5 g.) Program the unit for its minimum lockout interval (typically 1 to 5 min). verify that no fluid flows out of the set. Chassis leakage current to ground should not exceed 300 µA..5 Ω.2 Leakage Current. All Rights Reserved.21 Audible Signals.10 Flow Accuracy.23 Accessories. use an ohmmeter to check that a change in resistance (either low to high or high to low) occurs between the two conductors of the cable when an alarm condition is created.g. if so equipped. 1.5 mg bolus.. If the device incorporates a mechanism that automatically closes the set or requires the set to be manually closed before it is removed from the device. Determine the flow accuracy at two or more typical clinical flow settings (e. Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off.22 Labeling. Operate the device (e. Confirm appropriate volume. Follow this procedure to determine bolus volume accuracy of PCA pumps.g.. We recommend a maximum of 0. 1.g.Inspection and Preventive Maintenance System more of the above alarm conditions to determine whether they activate the nurse call. Check the condition of external airin-line and drop sensors. mg).1 Grounding Resistance. If the device or its IV pole has an accessory outlet. electrical safety analyzer. as well as equipment plugged into a multiple-outlet strip (“Waber strip”) so that all are grounded through a single line or extension cord. Measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis with an ohmmeter. and calculate the delivery rate in mL/hr. verify the operation of this mechanism.. Quantitative tests 2. and instruction cards are present and legible. for pumps programmed in volume units (e. (Choose the correct fluid code when testing volumetric controllers. collect and determine the average value of three 1. . if so equipped. and any other test variables to facilitate the comparison of results with those obtained during future inspections. This includes other equipment that is plugged into the primary device’s accessory receptacles. and then collect and determine the average value of three boluses. 1. 1 g/mL can be used for most other test solutions [e. if present. although the mass per unit volume of some fluids may differ significantly). confirm operation by passing a pen or finger between the sensor while watching for activation of the drop indicator. It may be desirable to record the type of tubing.24 Flow-Stop Mechanism(s). Alternatively. Check that all necessary placards. After cleaning the drop sensor. 4 Inspection and Preventive Maintenance System ©1995 ECRI. 1.) Use a stopwatch or a watch with a second hand to time the delivery into the graduated cylinder until at least 10 mL is collected.. 10 and 100 mL/hr).5 mL ÷ 15 hr = 0. Turn the power off with the infusion set primed and loaded in the device. gravimetrically determine device accuracy by weighing a small beaker (covered with a film of plastic wrap to minimize evaporative losses) before and after collecting a mass of at least 1. With all tubing clamps open and the fluid container two feet or more above the device. Clean sensors according to the manufacturer’s instructions.

Calculate the number of drops per minute for each trial. If the pressures are outside the unit’s specifications. for critical applications.. following the procedures in Item 2.g. Inspection and Preventive Maintenance System ©1995 ECRI. perform the following test.g. Test alarm pressures at two commonly used flow settings (e.Infusion Devices If an electronic balance is not available. 5 . In addition. the error should not exceed 5%. use a small length of rubber hose to connect the infusion set to the base of a vertically mounted. All Rights Reserved. Instead. Divide the collected volume (1. and average the two rates if they are different. if required.1 mL). and start the infusion. If the unit is designed to count drops and the delivery rate can be set only in drops/min. respectively.) 2.1 Clean the exterior and the interior of the unit. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. Before returning to use Ensure that the unit’s battery is fully charged and that the case is properly reassembled to minimize the risk of fluid entry. do not attempt to convert to mL/hr. The maximum pressure of newer pumps is typically 20 psi or less. minimum) by the collection time to calculate the infusion rate. Infusion controllers are typically specified to deliver within 10% of the flow setting or drop rate. test at high and low settings. (Slight variations may be due to the control circuitry correcting for errors. Pay particular attention to solution deposits on mechanical infusion control mechanisms. use the following formula: % Error = Actual rate − Desired rate × 100% Desired rate alarm pressure(s). To calculate flow error. 10 and 100 mL/hr).10. Replace the battery. Determine flow accuracy at minimum and maximum flow settings.) Exercise extreme care during measuring to ensure accurate test results. and occlusion or pressure-sensing mechanisms. For units that have adjustable occlusion alarm pressures. verify upstream occlusion detection by activating infusion with the tubing clamped just below the container. Converting drops to milliliters is complex and only grossly assesses the device’s ability to deliver fluid volumes. If the device delivers from an external fluid container. drop and air-in-line detectors.) Expect greater delivery errors (up to 15%) with enteral feeding pumps. 15:182-4. 3. Operate the device for several more minutes. (Exclude infusion controllers from these tests because of their inherently low operating pressures.) Determine the unit’s specified downstream occlusion 3. see Health Devices 1986 Jun.11 Maximum Pressure/Occlusion Alarms. Calibrate per the manufacturer’s specifications. (Note: Negative and positive flow error represents underdelivery and overdelivery. graduated 5 mL pipette (resolution to 0.3 3.4 4. Preventive maintenance 3. Although most intravenous infusion pumps are specified to deliver within 5% of the flow setting. infusion controllers should not be used for critical intravenous infusions). consult the service manual for making the necessary corrections.. Be sure that infusion devices are used appropriately (e. and then count the drops falling into the drip chamber for 2 min.5 mL. if necessary. and repeat the count. (Some pumps do not have this capability. 10% is acceptable for most applications. 4.1 Flow Accuracy. operate the device for 3 to 5 min at a midrange rate setting. Connect the distal end of the primed administration set to a pressure meter.

Type Major Minor ECRI-Recommended Interval 6 months NA Interval Used By Hospital months months Time Required . 1989 Mar-Apr. Hospital Assessment. 16:135-76. counterpulsation units Commonly Used In: Critical care units. High.) Inaccurate blood pressure readings on IABP patients [Hazard]. 1981 Nov. PA 19462-1298. Test apparatus and supplies Aortic simulator (see the “Test Equipment” section of this binder) Transducer simulator (or pressure transducer and accurate pressure source). for patients with unstable angina who are not responding to medication and who may be helped by revascularization surgery. as a precaution before revascularization surgery after arteriography has indicated a coronary lesion.Procedure/Checklist 432-0595 Intra-Aortic Balloon Pumps Used For: Circulatory Assist Units. Intra-aortic balloon pumps [Evaluation]. (See also 1987 Jun. 11:3-39. operating rooms Scope: Applies to all intra-aortic balloon pumps. Their most frequent and successful use has been with cardiac surgery. intraoperative. 093755 432-0595 A NONPROFIT AGENCY 5200 Butler Pike. in high-risk patients (patients with left main coronary artery occlusion or poor left ventricular function). or postoperative aid to open-heart surgery. 1987 May.org . Intra-aortic balloon pumps have been used for several types of heart disease. these devices were evaluated in Health Devices 1980 Jan. 9:59 ECG simulator Leakage current meter or electrical safety analyzer Ground resistance ohmmeter Expendable supplies such as a stopcock and syringe and other tubing and fittings for connecting test equipment Leak-detecting solution Transducer connector (may be required to gain access to monitor terminals) (acceptance inspection only) Citations from Health Devices Intra-aortic balloon pumps [Evaluation]. and for weaning patients with low cardiac output from cardiopulmonary bypass. ECG and pressure monitors in these units should be inspected using the appropriate Inspection and Preventive Maintenance Procedures Risk Level: ECRI Recommended. catheterization labs. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. hours hours Overview An intra-aortic balloon is placed in the descending aorta and controlled by a complex electromechanical system in an attempt to lower the pressure the heart has to work against and to provide better coronary and systemic perfusion. applied as a preoperative. 16:216. Intra-Aortic Balloon [10-846] Also Called: IABPs. . 18:138. Plymouth Meeting.

consider a full inspection of the receptacle. or if the damage is near one end. insert an AC plug into each and check that it is held firmly. If damaged. If additional cables are provided for slaving pressure or ECG signals to other units. check their function and condition. Tubes/Hoses/Moisture. After clearing moisture. the significance of each control and indicator. inform IABP users that moisture has accumulated during use and instruct them to clear the system of moisture after each use. kinked. Inspect ECG electrode and pressure transducer cables and any interconnecting cables between modules for neat and secure routing.10 Fittings/Connectors. for moisture.9 Cables. AC Plug/Receptacles. be sure that you understand how to operate the equipment. Inspect the cord for signs of damage. consult the operator’s manuals or manufacturers. Be sure no moisture has accumulated in the pneumatic pathway. See the operator’s manual for specific instructions on how to clear moisture. this feature may be included in some electrical safety analyzers (acceptance inspection only) accessories are plugged and unplugged often. where appropriate.. carefully read this procedure and the manufacturer’s instruction and service manuals. or dirty. If the device has a switch-type circuit breaker. briefly operate the balloon pump with the tubing attached to determine if there is moisture in the unit.7 1. Check that tubing is secured away from any elements that may become hot and that it has proper strain relief. For specific instructions on how to perform tests or inspections. Spare ECG and pressure cables should be kept with the unit. and be sure that they turn and swivel. Look for accumulations of lint and thread around the casters. Circuit Breaker/Fuse. cut out the defective portion..4 1. . fittings. Be sure to wire a new power cord or plug with the same polarity as the old one.3 1. condition.2 1. Attempt to wiggle the blades to determine that they are secure. check that it moves freely. Qualitative tests 1. and connectors in the pneumatic pathway. be familiar with the operation of the unit to be inspected.g. either dry it or replace the tubing. If moisture is in the tubing. Conductivity checks. 1. Examine the AC power plug for damage. Check the condition of all tubing in the unit. 1. If unit components (e. Clean or replace as necessary. Check the condition of all gas manifolds. Examine the exterior of the unit for cleanliness and general physical condition. check its value and type against that marked on the chassis.8 1.5 Line Cord. Procedure Before beginning an inspection. are usually done more efficiently as part of a check of all equipment and furniture in an area. Casters/Brakes. Be sure that they hold the cord securely.6 1. and the alarm capabilities. Shake the plug and listen for rattles that could indicate loose screws. If the isolation system is not transparent.1 Chassis/Housing. If any damage is suspected. Inspect the patient isolation system. that all assembly hardware is present and tight. and ensure that a spare fuse is provided. If the device moves on casters. If 1. as appropriate. Examine all gauges and 2 Inspection and Preventive Maintenance System ©1995 ECRI. if the unit is so equipped. If the device is protected by an external fuse. Be sure that tubing is not cracked. All Rights Reserved. Check the operation of brakes and swivel locks. 1. check their condition. blood pressure monitors) are independent modules on the console. Mount/Fasteners. Check cable (ECG and blood pressure ports) on consoles to ensure that connectors are in good condition (e. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Inspection test methodology and criteria may vary from unit to unit. If the device has electrical receptacles for accessories. where applicable. customize this procedure as required. ECG. Be sure that plastic housings are intact. Also check line cords of battery chargers. Since available intra-aortic balloon pumps differ considerably and are relatively complicated life-support devices. Strain Reliefs. no bent pins or cracked connectors).g. Record the hour meter reading and (when applicable) note the software version before beginning the inspection. open the plug and inspect it. replace the entire cord. check mounting of modules to ensure that they are securely attached. and strain reliefs. and that there are no signs of spilled liquids or other serious abuse. Examine the strain reliefs at both ends of the line cord.Inspection and Preventive Maintenance System Isolation test supply.

Examine all controls and switches for physical condition. confirm that it charges the battery. Verify that ECG electrodes and pressure transducers and disposable domes.Intra-Aortic Balloon Pumps valves for general condition.) 1. indicators. if necessary. always leave the unit plugged in so that batteries may charge. Before operating the unit on battery power for a prolonged period. drive solenoids. confirm the operation of all lights.16 Fluid Levels. and cooling fans. 3 . Verify automatic switchover to battery power. balloon disconnect). 1.. since it eliminates most battery failures and the problems of unscheduled battery replacement. if provided.1 and 3. Before moving any controls and alarm limits.21 Audible Signals. Check the fluid level in the dome and syringe of the Mansfield (now Boston Scientific) unit.g. secure mounting. Replace pump diaphragms. check the specific gravity of leadacid batteries. If leaks are suspected.2 and 3. and refill with distilled or sterile water. if so equipped. annual battery replacement may prove to be cost-effective. Check the condition of the battery charger. Examine all regulators and pressure gauges or meters for signs of damage or abuse. When it is necessary to replace a battery. (Depending on how heavily your hospital relies on rechargeable batteries for IABP operation. 1.12 Filters.4 of the form. label it with the date. 1. trigger loss. replace the batteries during the inspection procedure (unless the operator’s manual requires more frequent replacement). and note this on Lines 3. check for proper alignment. leak detectors. Clean or replace as required and indicate this on Lines 3.20 Alarms/Interlocks. be sure to check that each control and switch performs its proper function. If any of them appear inordinate. valves. (The dome should be full when the syringe is empty.4 of the inspection form. 1. consider the possibility of inappropriate clinical use or incipient device failure. Check the battery date code. Check membrane switches for membrane damage (e. Confirm that the ECG and pressure monitors’ calibration functions operate properly. heart rate. as well as positive stopping. if used.19 User Calibration. check their positions. trigger change. for expiration. if so equipped. If audible alarms have been si- Inspection and Preventive Maintenance System ©1995 ECRI. balloon deflation). be careful not to spill or drip the solution on electronic components. Check that charging lights or battery status meters are operative. if readily accessible. and to the extent possible. from fingernails. or gaskets. 1. If the unit has digital displays. 1. most of the inspection procedure can be performed with the unit operating on battery power. Operate the device in such a way as to activate audible and visual alarms (e. During the course of the inspection. Confirm appropriate volume.18 Indicators/Displays. Where a control should operate against fixed-limit stops. lubricate as required.11 Electrodes/Transducers. if provided.. Check the function of any associated interlocks (e. During the course of the inspection. and visual displays.. 1. be sure that all segments of the display function properly. Record the settings of those controls that should be returned to their original positions following the inspection. Inspect the physical condition of batteries and battery connectors. be sure there is adequate time for recharging or that an alternate unit is available. If pneumatic systems pass near electronic portions of the units. gauges. All Rights Reserved. Operate the unit on battery power for several minutes to check that the battery is charged and can hold a charge.g.g.15 Motor/Pump/Fan. Inspect and confirm the physical condition and proper operation of vacuum and pressure pumps. Check operation of battery-operated power-loss alarms. Check fluid levels in lead-acid batteries where appropriate. are on hand and in good physical condition. Check the condition of air filters in the pneumatic pathway associated with the compressor or vacuum pump and filters associated with fans for cooling electronic components.) Where appropriate. 1. and correct motion.17 Battery/Charger. check tubing and high-pressure regulator connections for leaks using a leak-detecting solution. When not in use. This is particularly true for transport models. The unit should be placarded LEAVE PLUGGED IN AT ALL TIMES. pens).13 Controls/Switches. meters. Operate the device to activate any audible signals. vacuum or pressure loss. as well as operation of the volume control. If required. 1. To further assess rechargeable battery capacity.

g. standby. 1:2. Driving System.) Datascope and Mansfield (now Boston Scientific) pumps. including on.) Leak Detector. 1:3).7 2. contact Kontron or consult the operator’s manual to determine the appropriate rate for the model being tested. 1. If helium pressure is below 250 psi or if the IABPs indicate that the gas is low.5 2. and the deflation point.10 in Blood Pressure Monitors Procedure/Checklist 434. The following describes tests appropriate for units currently in common use. and record the maximum leakage current. insert a T-piece in the balloon catheter and connect a 25 cc syringe to the third port on the T. The test method will vary with the model being tested. tanks should be replaced if the pressure is below 850 psi.23 Accessories..Inspection and Preventive Maintenance System lenced.22 Labeling. inflation duration. Using an ohmmeter. ECG Monitor. and off. The Aries leak alarm circuitry is designed to trigger if the system detects a gas leak rate exceeding 3 cc per min.10 Volume Displacement. labels. Leave 4 Inspection and Preventive Maintenance System ©1995 ECRI. or multimeter with good resolution of fractional ohms. Check that all necessary placards. Kontron IABPs are also designed to detect leakage by leak rate.) Recheck the pressure after a new tank is installed to verify that it is full and that the gauge or meter is functioning properly.1 Grounding Resistance. Using the aortic simulator and an ECG simulator. Test the unit by withdrawing gas at a rate of approximately 4 cc per min to verify that the alarm is operating. make sure that the location of spares is placarded on the unit. All Rights Reserved. otherwise. 1. Leakage current should be 300 µA or less. Set the ECG simulator to a heart rate of 90 bpm and observe the ECG signal on a monitor. confirm the proper operation of the controls for timing and triggering of the balloon pumping on each unit. electrical safety analyzer. 120 bpm). Pressure Monitor. Measure chassis current to ground with the grounding conductor temporarily opened. Using the aortic simulator.6 Frequency Weaning. 1. (Since CO2 maintains a constant pressure of 850 psi at room temperature until all the liquid is converted to gas. timing adjustment charts. and magnet (i. 11 to 12 cc of gas must be withdrawn before the units will alarm.) 2. Withdraw gas in 1 cc increments until a leak alarm sounds. replace the gas tanks with full tanks and arrange to have them refilled. measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis.. confirm proper vacuum and pressure levels during operation at high heart rates. check its grounding to the main power cord. a pressure of less than 850 indicates that replacement is required. verify grounding of the mainframe and each module. Follow Item 2. also follow External Pacemakers Procedure/Checklist 418. (If a pacemaker is incorporated and is intended to be used. . Using a 40 cc balloon in the aortic simulator.5 Ω.4 2.g. Verify that the frequency is what is indicated on the control knob position. Operate in Auto mode.24 Gas Supplies. Confirm the presence and condition of safety chambers. for Mansfield [now Boston Scientific] “Telewire” transmitter). (At leak rates of 3 cc per min or less. If CO2 is used with your unit. Be sure 2. Typically. Leakage Current. Triggering/Timing.3 2. Set timing controls for several settings and confirm changes in the balloon inflation point. Follow ECG Monitors Procedure/ Checklist 409. alert clinical personnel to the importance of keeping alarms at the appropriate level. Balloon should completely deflate and inflate (depending on timing control position) even at high rates (e. the back pressure created by the restriction may trigger alarms on some units.8 2.. Aries and Datascope pumps. that the diameter of the orifice through the Tpiece is not significantly smaller than the catheter diameter. Check the operation of the weaning control by applying a simulated ECG signal and setting the unit for 1:1 pumping. the Aries will automatically compensate for the gas loss by repriming the system with helium. Operate the device in all normal modes. Check pressure of gas tanks. observe the response when the setting for pumping frequency is changed to alternate settings (e. We recommend a maximum of 0.2 2. 2. If the system is modular. Set the IABP to fully inflate the 40 cc balloon in the simulator. patient isolator. and instruction cards are present and legible. (Operation of the Aries in Manual and the Datascope 90 in Manual-fill mode will disable leak alarms.e. If the device has an accessory outlet. Quantitative tests 2.

connect IABPs to monitors as they are commonly connected in your hospital and attempt to trigger the pump. It should be within 10% of the setting. Check the number of hours of use since the last inspection and the hours of use on safety chambers (Datascope). (Note: After running the unit on battery during this inspection procedure.1 3. Verify that cooling fans are drawing air through the console housing once the panels are back in place. Be sure clinical personnel know how to change these components. If significant decreases in displaced volume occur (40%). setup. we recognize that this is a relatively common practice. 5 . if adjustable.) 3. contact the IABP manufacturer to obtain its recommendations. note the date installed and the hour meter reading at installation. Be sure that an alternate IABP is available during the interim for clinical use.2 3. and function before using. the unit may not pump effectively. (This type of test will not guarantee equipment compatibility. In addition.000 hours or every year. Contact the manufacturer. As further verification. All Rights Reserved. External Pacemakers Procedure/Checklist 418). be sure to verify that the unit works properly by attaching and pumping a 40 cc balloon in the aortic simulator.1 Compatibility with ECG and BP monitors. ventilation filters. While we generally recommend against slaving IABPs off separate patient monitoring systems. If your hospital interfaces IABPs with monitors. Datascope every 1. Check displacement again at volumes of 30 and 20 cc. or diaphragm isolators (Mansfield/Boston Scientific). 434. Using an ECG or arterial pressure waveform simulator. valves. Blood Pressure Monitors Procedure/Checklist Inspection and Preventive Maintenance System ©1995 ECRI. are set loud enough to be heard in the clinical setting. (Run the test with a low trigger rate to aid in measuring the displacement. Preventive maintenance 3.4 Clean the exterior.000 hours or by the expiration date. perform the following test. gaskets. 4. if needed. 4.Intra-Aortic Balloon Pumps the chamber open to the atmosphere. On the inspection form. it is prudent to allow the IABP to fully recharge before returning the unit to use. Mansfield/Boston Scientific every 250 hours). If any gas hoses were removed or replaced during inspection or servicing. Be sure that the battery is charged or the unit is charging.) Place a CAUTION tag in a prominent position so that the next user will be careful to verify control settings.) Close the chamber to the atmosphere and increase pressure in the simulator to 40 and then to 60 mm Hg. Replace pump diaphragms. conduct the appropriate tests in the General Devices Procedure/Checklist 438 and acceptance tests for ECG and blood pressure monitors and pacemakers (ECG Monitors Procedure/Checklist 409. start the pump. Observe the displaced volume when fully inflating the balloon. and diaphragm isolators. but should identify units that are grossly incompatible. gas line filters. verify that the IABPs purchased are compatible with the monitors to which they may be connected. We have received several reports of difficulties users have experienced when trying to interface monitors with IABPs. safety chambers. and observe the fluid displaced in the simulator. Lubricate per the manufacturer’s instructions. Acceptance tests In addition to the tests described in the major inspection procedure. Replace these according to the manufacturer’s recommendations (Aries every 2. VLDs (Aries). Before returning to use Make sure controls are set at normal positions and that alarm volumes.

even in areas in which they are not currently required. This term is commonly used to denote the current that the meter predicts will flow through a line-to-ground short. which usually do not have meters to monitor the total hazard index but which will give audible and/or visual indication after the limit has been exceeded (exceptions noted in the text) Risk Level: ECRI Recommended. Periodic inspection and appropriate record keeping is required for all installed systems. and degradation in isolation can go unnoticed. Low. emergency rooms). codes and standards have required their installation in all anesthetizing locations. The front-panel test button and the alarms on many systems will indicate certain faults.g. Plymouth Meeting. NFPA requirements call for a monthly test that can be easily accomplished using the front-panel test button.2. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. Until recently. special procedures laboratories. in addition. The term “total hazard index” is used throughout this procedure to refer to the meter reading on the LIM. Type Major Minor ECRI-Recommended Interval 6 months NA Interval Used By Hospital months months Time Required . Section 3-5.org .4) locations (such as hydrotherapy areas). after any required maintenance. critical care units. we have examined isolated power systems in which even these features were not functioning properly. Our inspection procedure meets these requirements. most items are applicable to older static ground fault detectors.Procedure/Form 439-0595 Isolated Power Systems Used For: Isolated Power Systems [15-817] Line Isolation Monitors [12-361] Also Called: Isolated power centers Commonly Used In: Operating rooms and special care areas Scope: Applies to isolated power systems with dynamic line isolation monitors. The total hazard index is the greater of the currents measured when a leakage current meter 009081 439-0595 A NONPROFIT AGENCY 5200 Butler Pike. Although appropriate applications of isolated power systems continue to be debated. hours hours Overview Isolated power systems are nonspecialized power distribution systems in which neither load conductor is directly grounded and a detection device (a line isolation monitor [LIM] or ground fault detector) is incorporated to determine the extent of degradation of isolation.. and semiannually thereafter. The requirements also call for a more thorough inspection when the systems are first installed. should one develop. . Isolated power systems or alternative protective mechanisms are also required in “wet” (as defined in NFPA 99. these systems are currently required in operating rooms only if the operating room is not designated as a nonflammable anesthetizing location. their performance is generally taken for granted. Hospital Assessment. These systems have been widely installed in operating rooms and may also be found in other areas of the hospital (e. Once isolated power systems are installed. However. 1993 Edition. PA 19462-1298.

any of these special-purpose devices. 1988 May. It serves merely to establish a polarity convention.g. twist-lock. 17:170-1. the measurement current can be either AC or DC. depending on the condition of the system. Never test isolated power supplies that serve operating rooms. Isolated power systems [User Experience NetworkTM]. In the past. electrical safety analyzer.. The terms “Line 1” and “Line 2” are used to refer to the power-carrying (load) conductors of an isolated system. explosion proof.4 VDC. The second person will also prove invaluable for testing remote indicator panels and circuit breakers. or simply an ohmmeter. If it is necessary to test systems in other areas of the hospital while patients are present. so long as it meets the above output limits and has adequate resolution and accuracy for the test. expedites the inspection process. Hospitals that intend to inspect isolated power systems on a regular basis should purchase and use these types of devices. is satisfactory. and alleviates the need for many of the previously required extra wires and adapters. an AC measuring source is required for postconstruction tests) Parallel-blade receptacle tension tester (optional) Long lead with probe (long enough to reach from a control grounding point to all areas of the room) Citations from Health Devices Isolated power systems [Evaluation]. can be a stand-alone device or one that connects to a leakage current meter. leakage current meters. In newer systems. The use of such devices significantly decreases the risk of shock. one line is wired with orange insulated wire. several test devices using different measurement methodologies are available. Several manufacturers currently make devices that can be used in conjunction with electrical safety analyzers. and. Special precautions Because checking isolated power requires that measurements be made on energized power lines. the other line has brown insulation. 1993 AugSep. for periodic measurement in existing construction.g. check with clinical Test apparatus and supplies Isolated power system analyzer (optional for routine inspections). and voltmeters to inspect isolated power systems. or voltmeter (see Special Precautions and Health Devices 1988 Oct. many of the following items will not be necessary. x-ray) used in the systems to be inspected. or special procedures rooms while procedures are underway. in turn. catheterization labs. 1974 Aug-Sep. if used. Electrical safety analyzers [Evaluation]. and in areas distant from the testing site. 16:283-309). a safely constructed test fixture with a single resistor (2W) and a three-position switch — Line 1 to ground. twist-lock. one can summon help or begin CPR. . any device used to determine ground quality or grounding resistance on occupied patient care areas must limit the output to 500 mV RMS [1.. for routine major inspections.4 V peak-to-peak] or 1. and allow safe connection to test equipment without exposed conductive surfaces that could pose a shock hazard Adapters that plug into the power receptacles (e. it is possible for personnel to contact full line voltage. The designation is strictly arbitrary and may not appear on the wiring itself within the system. Electrical outlets in anesthetizing locations. explosion proof. We strongly recommend that isolated power systems be inspected by a team of at least two people so that. Exercise the same precautions used when testing or working with a conventional grounded system. between each load conductor and ground. Line 2 to ground — can be used (resistance value specified in Item 7) AC voltmeter for measuring line voltage Leakage current meter or voltmeter capable of measuring 10 to 500 mV Adapters that plug into the power receptacles (e. 3:243-58. parallel blade. off.Inspection and Preventive Maintenance System is connected. it was necessary to use separate meters and variable resistances that were interconnected through a variety of test leads and adapters with the isolated power system by the person(s) doing the inspection. 17:283-309. Isolated power systems deliver substantial currents through line-to-line contacts. in the event of an accident. 1988 Oct. All Rights Reserved. x-ray) used in the system that have an exposed ground connection and can be hooked to a trouble light or some other load to verify the presence of AC power (120-240 V) Grounding cable that plugs into special grounding receptacles used in the system to be checked Ground resistance ohmmeter (to avoid risk to patients in the area in which testing is being conducted 2 Inspection and Preventive Maintenance System ©1995 ECRI. contacts from line to ground may yield hazardous currents. 22:420.

2. overhead lighting. In most cases. In addition. a locked breaker panel is inappropriate because it will delay restoration of power following a fault. kΩ resistor that can be switched from ground to Line 1 or Line 2. Check the physical condition of display and circuit-breaker panels.g. clocks) that is powered by the isolated power system. If the LIM has accessible fuses. location of remote indicators and alarms. and circuit breakers. Inspection and Preventive Maintenance System ©1995 ECRI.) Items 1 through 9 constitute a simple operational check of the system to be performed routinely. 6. to verify that they are functioning. Be sure that the fuseholders are in good condition. Be sure that the audible and visual alarms reset following this test. pivots to nominal zero. If it is not placarded. It may be necessary to actuate the test feature to check certain lights. including indicators. When the alarm-silence button is actuated. verify that no changes have been made since the acceptance inspection. All Rights Reserved. These and the remaining items constitute an acceptance procedure. Check all indicator lights.g. meters.. list all fixed or permanently connected equipment (e. The sketch is not required if receptacles are assigned identification numbers and labeled during acceptance testing. Examine and manually operate each primary and secondary circuit breaker associated with the isolated power system. check the specifications for the LIM.. This includes nameplate data on the isolated power system. Remember to test all remote indicators. If a light is burned out. including any remote indicators. Verify that they are not cracked or broken. it should advance to the trip level). This value can be helpful in diagnosing failures in the LIM (normally. The sketch should provide some orientation (e. location of bed or operating table. check that the needle 7. by removing its fuse). Be sure that the LIM meter is in good condition. Confirmation of LIM Function. meters.”) 4. can be copied for routine inspections. Physical Condition. fill in the required identification information at the top of the form. (An isolated power analyzer or a calibrated. This test confirms that an alarm will occur for a fault that would result in a 5 mA hazard current. (An otherwise blank form. The needle should not be bent and should advance smoothly when the test button is pressed. Their rating should be placarded near the fuseholder. Alarms and Silencing Feature. If the circuit-breaker panel is usually locked. it may be more convenient to make a test fixture by wiring an appropriate plug with a 24. Ensure that colored lenses over the indicator lights are intact. with this information filled in. If it is possible to disable the LIM (e. Although they are listed separately for clarity. A proportionately higher resistance may be used Procedure The Universal Inspection Form is not applicable to this procedure. especially if the breakers are located in the same room that they serve. do not assume that a fuse of the correct value is installed.) Confirm that the visual and audible alarm indicators are activated for each of these connections. and that viewing and access are not obstructed. Qualitative and quantitative tests 1. or 48. Meters.g. For new installations. Repeat the test with this same resistance connected between Line 2 and ground. (Note: This test does not confirm LIM accuracy and does not need to be performed during acceptance testing when Item 10 is conducted.) Connect a 24 kΩ resistance (for 120 V system or 48 kΩ for a 240 V system) between Line 1 and ground. The audible alarm may or may not automatically reset upon resolution of the alarm condition. Most LIMs have at least two buttons or switches — one to test the alarms and one to silence the audible alarms. Record the reading on the LIM when the alarm test button is actuated.g. that they do not show signs of fluid entry. However. checks of several items (e. Lights. adjustable resistance can be used for this test. 5.. A box is provided on the form to sketch the layout of the room or area served by the isolated power system to identify the location of defective components or receptacles. x-ray view boxes. lights. Actuate both to verify proper function. Use the special Isolated Power System Form 439. determine whether this is a necessary precaution. and type of power receptacle. 3. Fuses. doors).Isolated Power Systems personnel to ensure that tripped circuit breakers will not compromise patient support or safety in the area. replace it or note the type on the inspection form to facilitate replacement. 3 . there should be a visible indication either that the system is still in alarm or that the alarm is silenced. examine them for condition and rating. alarms) can be performed simultaneously. Circuit Breakers. (Note: The left end of the scale corresponding to the de-energized meter may not be labeled “0..

Inspection and Preventive Maintenance System for confirmation at the 2 mA level (e. we recommend that this be measured.. the reading in µA is then numerically equivalent to the voltage in mV. If an analyzer with adjustable trip point adjustment is used. Connect the other lead to the ground contact of each receptacle in turn. It is only necessary to record any defective outlets that are found. the alarm should activate at resistances at or above those specified here. If the test is postponed because it will be included as part of the receptacle inspection procedure.000 Ω impedance at line frequency. Although measurement of retention force on the power-carrying prongs is not required.g. Replace chipped or broken receptacles and cracked faceplates. The insertion and removal of the plug should be smooth. Grounding Jacks. voltages in modern construction are usually <10 mV.) Connect one lead of the meter to a reference ground point that is known to be securely grounded.. twisting the plug in the receptacle. All Rights Reserved. If leakage readings are used. (Most leakage current meters have a 1. Examine all installed grounding jacks for general physical condition. If all outlets are satisfactory. If the receptacle is explosion proof. because this may not be adequately grounded. A retention force of 4 oz is also adequate for these prongs. Verify that each receptacle has power by plugging a lamp or trouble light into the receptacle (a 240 V bulb is needed for x-ray outlets). broken locking pins) in the receptacle or other damage that prevents insertion or retention of the plug. Measure ground potentials with a voltmeter or leakage current meter. 60 kΩ for 120 V systems. For new construction. and verify that it is <0. Check explosion-proof and x-ray receptacles. put a line through both the Pass and Fail columns. However. Receptacles. and forces of 2 to 4 oz are satisfactory if the plug brand in use tends to stabilize at this value and does not continue to deteriorate.2 Ω (or 0. Measure the resistance between the grounding terminal of the receptacle (accessed through the adapter) and ground. the voltage should not exceed 500 mV in general care areas and 40 mV in critical care areas. NFPA 99 requires that the voltage limit between a reference point and grounding contact of each receptacle in the patient vicinity not exceed 20 mV. 8. but a ground plug or structural member can also be used. check that the lamp does not go on until the appropriate action is taken (e. Replace any outlet with less than 2 oz retention force on any prong. In existing construction. voltages >20 mV may indicate a deteriorating condition and should be investigated. A duplex to locking receptacle adapter (or duplex to x-ray) may be required. either directly or through an adapter (a 240 V bulb will be needed for x-ray outlets).1 Ω in new construction) and does not vary as the plug is jiggled in the receptacle.) A quantitative test of contact quality cannot be made in most locking receptacles. It is usually most convenient to use the ground contact of one receptacle. Do not use the cover plate screw. and differences of <20% should be considered insignificant. check Pass. the alarm should activate at readings no greater than 5 mA (or 2 mA for 2 mA LIM). Parallel-blade duplex receptacles can be checked either as part of the isolated power inspection procedure or during routine inspection of duplex receptacles in that area of the hospital (see Electrical Receptacles Procedure/Form 437).. rotating the cover plate). Leakage current readings can be converted to millivolts (mV) if the leakage current meter’s impedance is known. 9. . Be sure that withdrawal of the tester from the outlet is straight and smooth. make a qualitative test of the power contacts by plugging a movable floor lamp or trouble light into the receptacle. It should be understood that these limits are not precise. 4 Inspection and Preventive Maintenance System ©1995 ECRI. 120 kΩ for 240 V systems). It may be possible to combine the grounding contact test with the power test if a light with an accessible grounding point is used. (See Procedure/ Form 437 for additional information. Check the grounding contact of each receptacle. Insert a cable intended for that type of receptacle to make sure that there are no obstructions (e.g. Jiggle the plug and pull on it after it has been inserted and notice whether the light flickers. Instead. Measure the retention force of parallelblade outlets with a receptacle tension tester. Retention force on the ground prong must be 4 oz or more.g.

10. it may reflect the relatively poor accuracy of many AC voltmeters. 11. within 20%. significantly higher than 5 mA.Isolated Power Systems Check ground potentials and resistance as described in Item 8. However. the same criteria apply. so check your meter before blaming the system. Measure and record the output voltage of the system between Line 1 and Line 2. connecting the resistance from Line 2 to ground. and measuring the total hazard current from Line 1 to ground with a leakage current meter.g. with the LIM meter reading before the leakage current meter was connected. this condition should be corrected before the inspection continues. and either value is sufficient. then malfunction or miscalibration of the line isolation monitor is likely. depending on the isolation of that line. Otherwise. 120 V system. Testing after typical loads are applied or testing in existing facilities may indicate poor wiring or inadequate system capacity. Static LIMs may not alarm until the resistance is about 20 kΩ. resistance values between 60 and 120 kΩ indicate adequate isolation Inspection and Preventive Maintenance System ©1995 ECRI. it is not imperative that this value be obtained and recorded. record the average current. and LIMs with other alarm levels may be encountered. Record this resistance value and the total hazard index (LIM meter reading). This test verifies that the alarm will function when a suitable fault from one line to ground occurs. These measurements check system integrity and give further information on LIM meter accuracy. To satisfy current codes. Older dynamic line isolation monitors scan between Lines 1 and 2 at rates that can introduce marked fluctuations in meter readings. If the analyzer does not indicate the actual resistance used during this particular test. or major repairs to the electrical distribution system to ensure that voltage taps are set correctly. When the scanning rate is slow enough that two distinct readings can be distinguished on the meter. renovations. All Rights Reserved. Any significant deviation requires further investigation. adjusting it until the alarm sounds. Unplug all cord-connected equipment and turn off all fixed equipment (e. static detectors do not recognize balanced faults. System Leakage. the information obtained may be helpful in assessing a new installation and in future troubleshooting. Record this current reading. For a 2 mA. Line Voltage. The resistance required to cause an alarm and the system leakage current are both indications of the isolation of the system. 120 V system). The measured value should conform. The resistance between a single power line and ground that can cause an alarm varies. If a resistance higher than this value activates an alarm. it is indicative of inadequate isolation. it is important to perform the procedure for determining system leakage (Item 12) and to record system leakage values. Line voltage tests are not required by NFPA 99. the systems should operate within those specifications. within reasonable limits. In addition.g.. Comparing the readings Acceptance tests Items 10-14 should be done only after the system is first installed or if major modifications or repair have been performed on the system. While not essential if Item 10 is performed.. 12. Repeat this sequence of tests. (24 to 48 kΩ for a 5 mA. Alarm Levels. 5 . Reduce the resistance from a high value (e. However. and provides a measure of the degree of isolation from each line to ground. record the greater of the two values. Connect the analyzer and set it to apply a resistance between Line 1 and ground. under any circumstances. If resistances significantly below the expected value are required to generate an alarm. This current should not exceed 2 mA (5 mA on 5 mA systems) and should agree. to the value specified on the nameplate. it should not be. Static ground fault detectors may have alarm levels above 5 mA or more and may be beyond the range of some meters. This can result in nuisance alarms. (If the hazard index is above 5 mA. Examine the specifications of these special systems. 200 kΩ) until the alarm sounds. verifies the accuracy of the LIM meter. do not attempt the next step [measuring total hazard current] unless your meter is protected against line voltage. x-ray view box) from the system.) Measure the resulting total hazard current with the resistance in place on Line 1 by switching the analyzer meter to read from Line 2 to ground (the LIM meter will go to full scale). These tests should be performed following new construction.

All Rights Reserved. This value measures the collective leakage of installed wiring. use letter suffixes (e. Connect the leakage current meter between Line 1 and ground and note the reading. thus. To ensure that there will be adequate leeway on the system to cope with connected loads.000 Ω. voltmeter. Repeat this for all receptacles served by the isolated power system. Turn off all secondary circuit breakers and plug a light. . or other components. Repeat the measurement with the meter connected between Line 2 and ground. Installed lighting powered by the system (e. wiring. It is not necessary to be concerned about resistance to ground of isolated exposed metal as long as the potentials measured above are acceptably low. but without the degradation of isolation caused by the LIM. Record the hazard index indicated on the LIM with the isolated power system on. Measure the system leakage with the line isolation monitor connected. 6 Inspection and Preventive Maintenance System ©1995 ECRI. permanently attached. or other indicating device into one receptacle. repeat system leakage measurements. This represents leakage caused by impedance from Line 2 to ground. Circuit Breaker Function and Labeling.. system leakage (mA) should be <0. 13.2 mA for a 240 V system). A significant difference suggests a line isolation monitor malfunction. We recommend performing this test after new construction and significant modifications. transformer. 14. 8A. check that the receptacles and breakers are labeled (preferably by numbering) to indicate the relationship between them. or if the breaker serving the LIM can be turned off. electrically conductive surfaces that might become electrically energized and that might be touched by the patient or persons touching the patient. and individual branch circuit breakers or switches integral to the unit turned on. whichever yields the higher hazard index.. Tests and criteria are the same as for Item 8.6 mA for a 120 V system (1.g. overhead surgical lights. Testing is required following significant modifications and is recommended (but not required) at one-year intervals. As you go through the area. NEC (1993) no longer requires grounding of such surfaces. all cord-connected devices unplugged. it is a better indication of wiring degradation. arrange to permanently tag each receptacle with the number of the circuit breaker that controls it. Grounding of Exposed Metal. If the fuses of the LIM can be removed.5 mA for 5 mA systems.Inspection and Preventive Maintenance System with values obtained in previous inspections may indicate degradation of the isolation of transformers.g. x-ray view boxes) should be turned on or off. Determine the correspondence between circuit breakers and receptacles. and associated components. Record the two values and compare the greater one to the reading recorded for the LIM meter. NFPA 99-1993 calls for testing of installed. However. this value should be <1 mA for 2 mA systems and <2. 8B). If they are not labeled. if the grounding wire of the LIM can be disconnected. NFPA 99 states that the isolation must be >200. This can facilitate restoration of power should a breaker trip. Momentarily turn on one breaker at a time until the breaker controlling the receptacle is identified. If more than one receptacle is served by a breaker. therefore.

7 .Isolated Power Systems Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

Inspection and Preventive Maintenance System 8 Inspection and Preventive Maintenance System ©1995 ECRI. . All Rights Reserved.

Hospital Assessment. In pneumatic insufflators. introduced into the peritoneal cavity distends the abdominal wall to provide a viewing and working space within the abdomen. They feature displays. allowing the pressure in the transducer inside the insufflator to equalize with the abdominal pressure.org . typically at 10 to 15 mm Hg (0. typically CO2. Plymouth Meeting. hours hours Overview Insufflators are used to establish and maintain the pneumoperitoneum during laparoscopic procedures. Electronic insufflators typically deliver gas at a pressure higher than that desired in the pneumoperitoneum. gauges. abdominal pressure control is accomplished by limiting the pressure of gas delivered to the patient. Gas. 21:143-73. PA 19462-1298. Citations from Health Devices Laparoscopic insufflators [Evaluation]. 21:180-1. or other indicators for set and detected abdominal pressure and flow. Both pneumatic and electronic insufflators feature controls for setting the pressure and maximum flow rate. For electronic insufflators to accurately measure abdominal pressure. . 234107 466-0595 A NONPROFIT AGENCY 5200 Butler Pike. The maximum flow possible from a given insufflator varies depending on flow resistance introduced by inline tubing filters and by the stopcock connection through which the insufflator is connected to the patient. insufflator tubing. and external gas cylinder pressure or volume remaining. 1992 May.Procedure/Checklist 466-0595 Laparoscopic Insufflators Used For: Insufflators. insufflation of the uterus). 1992 May.e. Does not apply to insufflators for hysteroflation (i. these units limit abdominal pressure by slowing and then suspending flow when intermittent abdominal pressure measurements approach and reach a user-selected pressure. In pneumatic insufflators. volume of gas consumed..3 psi). Risk Level: ECRI Recommended. and the patient outlet port of the insufflator can stabilize. flow is typically specified as high or low. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. Medium. flow is briefly suspended so that pressure in the abdomen. short procedure and ambulatory surgery areas Scope: Applies to pneumatically and electronically controlled insufflators intended for introduction of CO2 or N2O gas into the peritoneal space. The primary function of the insufflator is to act as a pressure-controlled gas flow regulator. flow rates are specified either as a time-averaged flow or as an instantaneous flow. Entry of abdominal fluids into laparoscopic insufflators [Hazard]. In electronic insufflators. Laparoscopic [16-849] Also Called: CO2 Insufflators Commonly Used In: Operating rooms. The insufflator takes in compressed gas from a supply cylinder (700 to 850 psi) or wall outlet (50 to 100 psi) and delivers it to the patient.2 to 0. Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required .

All Rights Reserved.6 Strain Reliefs.1 Chassis/Housing. Check that control knobs have not slipped on their shafts. check the security of this attachment. Line Cord. Inspect the cord for signs of damage. Examine all controls and switches for physical condition. and check their physical condition. Examine the exterior of the unit for cleanliness and general physical condition. 1. Verify that the highpressure hose is pin-indexed for the appropriate gas (e. 24:252-85.) Circuit Breaker/Fuse. Examine the AC power plug for damage. Mount/Fasteners.10 Pneumatic Connectors. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. 1. If it is attached to a wall or rests on a shelf. AC Plug/Receptacles. Examine all external gas fittings and connectors. and indicate this in Section 3 of the inspection form. mercury manometers are not suitable) Large-bore (20 ga or larger) hypodermic needle Empty 500 mL and 3 L (one each) IV and/or anesthesia solution bags with at least two ports Trocar cannula or IV stopcock Stopwatch or watch with second hand 1. Qualitative tests 1. examine the condition of the mount. Be sure that they are not cracked. Examine the strain reliefs at both ends of the line cord. Check the condition of internal gas filters. If any settings appear inordinate (e. Inspect the gas outlet port for evidence of fluid entry. be sure that you understand how to operate the equipment. as well as electrical cable connectors. Attempt to wiggle the blades to check that they are secure. . kinked. (See Health Devices 1993 May-Jun. check their positions.g. If any damage is suspected.4 1. Where a control should operate against fixed-limit stops. If the device is protected by an external fuse.Inspection and Preventive Maintenance System Fatal gas embolism caused by overpressurization during laparoscopic use of argon enhanced coagulation [Hazard].5 2 Inspection and Preventive Maintenance System ©1995 ECRI. Electrical contact pins or surfaces should be straight. Record the setting of those controls that should be returned to their original positions following the inspection. Confirm that any necessary electrodes and/or transducers are on hand.11 Electrodes/Transducers. open the plug and inspect it. for general condition.2 1. 1. 23:257-9. check its value and type against that marked on the chassis and ensure that a spare is provided. Check the condition of reusable patient tubing and gas-supply hoses. and that there are no signs of spilled liquids or other serious abuse. 22:301-3. Shake the plug and listen for rattles that could indicate loose screws.g. If the device has an external circuit breaker. clean. If the device is mounted on a stand or cart. 1. which can indicate contamination by body fluids. Tubes/Hoses. 1994 Jun. and correct motion. High-flow laparoscopic insufflators [Evaluation]. If the line cord is detachable (by the user). 1. carefully read this procedure and the manufacturer’s instruction and service manuals. Gas fittings should be tight and should not leak. Be sure that plastic housings are intact.8 1. If damaged. 1995 Jul.. and bright. Test apparatus and supplies Leakage current meter or electrical safety analyzer Ground resistance ohmmeter Pressure meter or gauge (range 0 to 75 mm Hg. CO2 or N2O). damage is near one end. check that it operates freely. and the alarm capabilities. secure mounting. or dirty. that all hardware is present and tight. Verify that leads and electrodes are firmly gripped in their appropriate connectors. consider the possibility of inappropriate clinical use or of incipient device failure. affix the cord to the unit so that it cannot be removed by the operator. Before changing any controls or alarm limits.13 Controls/Switches. cut out the defective portion.7 Procedure Before beginning an inspection. check for proper 1. if the 1.12 Filters.. Follow the manufacturer’s recommended interval for service of internal filters (typically 2 years) and instructions for replacement. Be sure that they hold the cord securely. a pressure control at maximum). Clean or replace as appropriate. replace the entire cord or. the significance of each control and indicator.

indicate “DI” instead of the ground resistance value. Operate the device to activate any audible signals.1 Grounding Resistance. Operate the device in all normal modes. standby. grounding resistance need not be measured.20 Alarms. Displayed Pressure Accuracy.g. Introduce a largebore hypodermic needle through an injection port on the bag. Connect the insufflator to an empty 3 L solution bag.5 Ω. or multimeter with good resolution of fractional ohms to measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. If the system is modular or composed of separate components. Pressure Relief Mechanism. Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off. Induce alarm conditions to activate audible and visual alarms. and visual displays on the unit. be sure to check that eachcontrol andswitchperformsitsproperfunction. check the method of reset (e. During the course of the inspection. verify grounding of the mainframe and each module or component. use an ohmmeter. note the bag 2. and instruction cards are present and legible. In many cases. An insufflator should limit delivered pressure to a manufacturer-specified maximum value. 1.2 Leakage Current. It may not be possible to check out all alarms at this time. Check that any associated interlocks function. check its grounding to the main power cord. gauges. Be sure that all segments of a digital display function. With the insufflator connected to a filled 3 L solution bag. 2. measure chassis leakage current to ground with the grounding conductor of plug-connected equip2. some units also have vents that are electronically opened if the detected pressure exceeds a threshold value (e. these vents activate after a delay of several seconds. Connect the pressure meter or gauge to the hypodermic needle.5 Inspection and Preventive Maintenance System ©1995 ECRI. Quantitative tests 2.22 Labeling. 3 . In addition to a pressure-relief valve. as well as positive stopping. and verify that displayed pressure remains within 3 mm Hg or 10% of measured pressure. Note the bag pressure at which pressure relief occurs as indicated by the pressure meter or gauge also connected to the bag. since some may require abnormal operating conditions that will be simulated later in this procedure. alert clinical staff to the importance of keeping alarms at the appropriate level. 30 mm Hg) or if the detected pressure exceeds the selected pressure by a certain value. Manually compress the bag to produce pressure in excess of the set pressure. Chassis leakage current to ground should be 300 µA or less. For line-powered units.. If the unit has an alarm silence feature. Confirm appropriate volume. 1. 2. manual or automatic) against the manufacturer’s specifications.4 2. minimum.19 User Calibration. and a pressure setting in the range of 12 to 15 mm Hg and should be within 3 mm Hg of the pressure setting. 1.Laparoscopic Insufflators alignment.3 Set Pressure Accuracy.21 Audible Signals.18 Indicators/Displays.6 2. labels. confirm the operation of all lamps. record the maximum leakage current. conversion charts. High-Pressure Alarms. If audible alarms have been silenced or the volume set too low. as well as the operation of a volume control if so equipped. and off. meters. indicators. including on. as well as equipment plugged into a multiple outlet strip (“Waber strip”) so that all are grounded through a single line or extension cord. This includes other equipment that is plugged into the primary device’s accessory receptacles.3). Check that all necessary placards. whichever is greater. ment temporarily opened. Measurements should be taken at maximum.5). electrical safety analyzer. displayed pressure should be within 3 mm Hg of the measured pressure. All Rights Reserved. During the course of the inspection. For line-powered units.. Verify that any calibration function operates. 1. We recommend a maximum of 0. and measure the gas pressure in the bag after it has stabilized. If the device is double insulated.4 and 2. If the device has an accessory receptacle.g. 1. During the preceding two tests (Items 2. compare the displayed pressure with pressure measured with the pressure meter or gauge. manually compress the bag so that pressure is slowly increased 5 mm Hg at a time until pressure relief is activated. During the preceding test (Item 2.

g. 15 mm Hg) through the tubing/filter set intended for use with the insufflator. Replace filters. Before returning to use Ensure that all controls are set properly. 2. 15 mm Hg) through the tubing/filter 4. if required. With the insufflator set to its maximum flow setting.4 Clean the exterior (interior.2 3. Preventive Maintenance 3..11 Low Flow. It is important to minimize flow resistance in the connection between the insufflator tubing set and the reservoir bag [e.1 3. For this test. measure the time required to fill a 3 L solution bag to a typical pressure setting (e. Attach a Caution tag in a prominent position so that the user will be aware that control settings may have been changed.) 2. With the insufflator set to minimum flow setting. All Rights Reserved. measure the time required to fill a 500 mL IV reservoir bag to a typical pressure setting (e.Inspection and Preventive Maintenance System pressures at which intermittent and continuous audible alarms and visual indicators are activated.10 Maximum Flow. compute the flow using the following formula: flow (L⁄min) = (0. if required.g. and compare it to the flow established for that unit during acceptance testing.. . Lubricate per the manufacturer’s instructions. if required). If a trocar cannula or IV stopcock is used for this connection.. do not use a Veress or hypodermic needle for this connection]. Calibrate pressure settings. Set alarms loud enough to alert personnel in the area in which the device will be used. and compare it to the flow established for that unit during acceptance testing. 4 Inspection and Preventive Maintenance System ©1995 ECRI. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. (This measurement may differ markedly from the manufacturer’s specified maximum flow rate if it is specified as an instantaneous flow or is not adjusted for flow resistance of the tubing set and filter. Other controls should be in their normal pre-use positions.3 3. Insufflators should have a setting that delivers flow in the range of 1 to 2 L/min.5 L) × (60 sec⁄min) fill time (sec) 3. For this test.g. compute the flow using the following formula: flow (L⁄min) = (3 L) × (60 min) fill time (sec) sec⁄ set intended for use with the insufflator. it should be maintained as a permanent test device because flow resistance of stopcocks and cannulae varies significantly.

and Rh/Rh. a compression system. normal anatomy. five target/filter combinations for screen-film mammography are available: Mo/Mo. although many of the following tests will apply to these systems. a radiation shield. aluminum (Al). or rhodium (Rh) target on the anode receives the electron beam from the cathode and emits x-rays. . Currently. Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . xeroradiographic and digital receptor systems are not covered here specifically. tungsten (W).or 60-cycle input voltage to a frequency as high as 100 kilohertz) or constant-potential (they supply a ripplefree. a Bucky grid to reduce scatter radiation. this narrow range accentuates the subtle density differences in breast tissue. Mammographic [12-425] Commonly Used In: Radiology departments. continuous voltage to the x-ray tube. a positioning assembly.g. the kilovoltage (kV) settings range from 20 to 35 kV. biopsy systems are also not covered in this procedure Risk Level: ECRI Recommended. An automatic exposure control (AEC) device is used to terminate x-ray generation when a radiation sensor behind the film cassette senses the proper exposure. W/Mo. A mammographic radiographic system consists of an x-ray generator. Mo. thereby reducing radiation exposure and retakes. an x-ray tube. craniocaudal. For screen-film mammography. W/Rh. X-rays are produced by the x-ray tube.org . Mo/Rh. breast clinics Scope: Applies to mobile and stationary screening x-ray mammography units that use a screen-film receptor. Hospital Assessment. regardless of the input power). either automatic or manually operated. The target/filter combination selected for imaging depends on the thickness and density of the breast after compression.. hours hours Overview Mammography units use x-rays to produce a film image of the breast (a mammogram) that provides information about breast morphology. PA 19462-1298. which usually has a rotating anode that dissipates heat produced during exposure. High. A molybdenum (Mo). Mammography is primarily used to detect and diagnose breast cancer. mediolateral). and/or Rh filters are placed in the path of the x-ray beam to absorb unwanted x-rays. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. The x-rays that pass through the filter are shaped by a collimator or by cone apertures.Procedure/Checklist 467-0595 Mammography Units Used For: Radiographic Units. X-ray generators for mammography are usually high-frequency (they convert the 50. Plymouth Meeting. The positioning assembly is capable of vertical and rotational movement to adjust for different patient heights and breast sizes and to permit the acquisition of images from various angles around the breast (e. and an image recording system. as well as to evaluate palpable masses and nonpalpable breast lesions. is used to uniformly reduce the thickness of the breast to facilitate 237588 467-0595 A NONPROFIT AGENCY 5200 Butler Pike. and gross pathology. A compression system. AEC devices can automatically compensate for technique variance and patient anatomy (breast thickness).

1990 May-Jun. This film processor should be the one that is normally used to process all mammograms. 1. and the alarm capabilities.Inspection and Preventive Maintenance System x-ray beam penetration and maximize the amount of tissue imaged. For tests of the AEC and of image quality. ensure that the cables are completely discharged by repeatedly contacting the conductor to the ground as soon as the cables are removed from the wells. 19(5-6):152. Xeromammography. allow adequate time between exposures to prevent the x-ray tube from overheating.1 cm 10 cm of stiff wire Four coins or lead markers One dozen sheets of 18 cm × 24 cm mammography film from same batch One dozen sheets of 24 cm × 30 cm mammography film from same batch One 18 cm × 24 cm mammography cassette with screen One 24 cm × 30 cm mammography cassette with screen Densitometer Ten pieces of 15 cm × 15 cm × 1 cm plexiglass American College of Radiology (ACR) accreditation mammography phantom Oscilloscope (calibration only) High-voltage divider (calibration only) Procedure Before beginning an inspection. a method of electrostatic image recording using charged photoconductive plates. Acceptance testing is crucial because it generates data on baseline performance of the device. Quality assurance in screening mammography [Clinical perspective]. All Rights Reserved. It should not be construed as providing full compliance with the requirements of all governmental regulations and accreditation standards of professional associations. Citations from Health Devices Mammography units [Evaluation]. For repeated exposures. When removing them. as required by some of the tests in this procedure. be sure that you understand how to operate the equipment.or double-emulsion film. It should not be necessary to place hands or fingers in the x-ray beam. it is imperative that an optimally performing film processor be used. For acceptance testing. In screen-film mammography. or a combination exposure meter. carefully read this procedure and the manufacturer’s instruction and service manuals. . if this is unavoidable. Check the movements of the Carm assembly. Such regulations and standards may include testing beyond that provided below and may also require documentation by a certified medical physicist. wear lead gloves.1 Chassis/Housing. 18(1):3-53. This procedure is intended to ensure adequate system performance and maintenance. Be sure that all hardware is present and secure and that there are no signs of serious abuse. the significance of each control and indicator. 19(5-6):153-98. both for rotation and vertical movements. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Qualitative tests 1. Also. Test apparatus and supplies Ground resistance ohmmeter Leakage current meter or electrical safety analyzer Noninvasive mammographic kVp meter Noninvasive timer (may be included with the kVp meter) Ionization chamber with electrometer. the image recording system uses high-detail fluorescent screens that convert x-rays to light photons and that are in contact with a single. capable of making exposure measurements in the mammography energy range and specifically calibrated for this purpose Five high-purity (>99%) aluminum filters measuring 10 cm × 10 cm × 0. the technical tests should be undertaken using the same screen-film combination that is used for acquiring mammograms. we strongly recommend contracting with a medical physicist. 1989 Jan. Special precautions Wear a lead apron during all radiation testing and maintain a safe distance between yourself and the x-ray tube. Do not remove high-voltage cables from the wells with the power on. 1990 May-Jun. is still available on some mammography units. ensuring that all of its movements 2 Inspection and Preventive Maintenance System ©1995 ECRI. Mammography units [Evaluation]. Examine the exterior of the mammography unit for cleanliness and general physical condition.

from the AEC detectors to the generator. If the device is protected by an external fuse. Check the condition of the operator shield and the patient face shield. If any damage is suspected. AC Plug/Receptacles. if the damage is near one end.. Record the setting of those controls that should be returned to their original positions following the inspection. clean. Also check during these tests that the film cassette is retained securely but that it is not difficult to insert or remove. consider the possibility of inappropriate clinical use or of incipient device failure.Mammography Units are smooth and that the locks function adequately. Also pay close attention to the operation of the compression and decompression switches. Ensure that the mammography unit is securely mounted on the floor so that it is not likely to become unstable when a patient is leaning on the breast platform or when the technologist is moving the C-arm assembly. 1. Examine all electrical cable connectors for general condition.18 Indicators/Displays. be sure to check that each control and switch performs its proper function. Attempt to wiggle the blades to check that they are secure. Ensure that. and bright. Electrical contact pins or surfaces should be straight.4 1. particularly of the compression paddles and of the magnification platforms. replace the entire cord or.g. check the operation of brakes and the adequacy of the park positions of the C-arm assembly and of any other components likely to move during transport. cable to footswitches) and their strain reliefs for general condition. Also. 1. check their positions. Examine the strain reliefs at both ends of the line cord.3 1. Before changing any controls or alarm limits. If any settings appear inordinate (e. verify the presence of line power and insert an AC plug into each and check that it is held firmly.. as appropriate. For mobile mammography units. 1.10 Fittings/Connectors. ensure that the cooling fan in the tube head assembly is clean and operates adequately.6 1.15 Motor/Pump/Fan/Compressor. Release of pressure should immediately terminate exposure.g. cut out the defective portion. Circuit Breaker/Fuse. Cables. check for proper alignment. Inspect any cables (e. ensure that they do not stick and that continuous pressure is required to continue exposure. Be sure to wire a new power cord or plug with correct polarity. make sure that no pins are missing and that the keying is correct. Also check line cords of battery chargers. 1. During the inspection. For the radiographic exposure switches. Strain Reliefs. consider a full inspection of the receptacles. confirm the operation of all lamps. If damaged. 3 .9 Inspection and Preventive Maintenance System ©1995 ECRI. For line-powered mammography units.2 Mounts/Fasteners.) for physical condition. check the mechanical connections.13 Controls/Switches. very large preset density change or a kVp that is too low).5 1. If the unit has electrical receptacles for accessories (e. Clean and lubricate if necessary and note this in Items 3. Check the physical condition of the motor-driven compression mechanism. as well as positive stopping. Inspect the cord for signs of damage. Also. focal spot selection. and correct motion. If keyed connectors are used. filter selection. If the device has an external circuit breaker. have not slipped on their shafts. preset density change. Also. During the inspection.2 of the inspection form. and look for accumulations of dirt and grime around the wheels.1 and 3. if present. verify that the wheels turn and swivel. 1. compression and decompression switches. technique selection. Check that control knobs. Line Cord.. automatic decompression follows exposure. examine the AC power plug for damage. If accessories are plugged and unplugged often. check its value and type against that marked on the chassis and ensure that a spare is provided. Be sure that they hold the cord securely. 1. Shake the plug and listen for rattles that could indicate loose screws. Verify that there are no intermittent faults by flexing electrical cables near each end and looking for erratic operation or by using an ohmmeter. open the plug and inspect it. etc. Examine all controls and switches (x-ray initiation. All Rights Reserved. Casters/Brakes. indicators.7 1. printers). Ensure that the connections permit safe and adequate attachment of these devices. secure mounting.g. Verify that leads and electrodes are firmly gripped in their appropriate connectors. Carefully examine cables to detect breaks in the insulation and to ensure that they are gripped securely in the connectors at each end to prevent rotation or other strain. where provided. Where a control should operate against fixed-limit stops. check that it operates freely.

calculate them from the mAs values by factoring out the mA the unit uses at 28 kVp for that focal spot.5 Ω. where available. 1. Induce conditions to activate audible and visual alarms (for example. All Rights Reserved.1 Grounding Resistance.4 Timer Accuracy. use a safety analyzer to measure leakage current. Accuracy of kVp. 1.e. Use a noninvasive kVp meter capable of making measurements in the mammographic energy range. or multimeter with good resolution of fractional ohms. Handswitches and footswitches that are powered from low voltages need not be grounded. a documented maintenance schedule should be implemented to ensure the integrity of the grounding connection. Confirm appropriate volume. For all measurements. Using an ohmmeter. . A voltage reading below 500 mV is acceptable for general care areas in existing construction. unpainted and not anodized) metal on the chassis.23 Accessories. Note that for existing mobile units. gauges. warning labels. 2. manual or automatic) against the manufacturer’s specifications. grids. electrical safety analyzer. Although confirmation of grounding integrity provides reasonable assurance of safety.g. technique charts.. After appropriate corrections have been applied to the measured kVp readings (e.. Make measurements at a minimum of three kVp settings that span the range normally used at your facility. Permanently wired equipment should be tested before installation. 2. and C-arm rotation indicators. If the noninvasive kVp meter also displays exposure times. if the leakage current is between 300 and 500 µA. long exposure times). the distance at which the kVp meter has to be placed).. 1. but. leakage currents of up to 500 µA are deemed not to pose a hazard. x-ray exposure. use a fixed tube voltage setting of 28 kVp. 2. backup timer activation). It may not be possible to check out all alarms at this time. leakage current should not exceed 5 mA.. Using a voltmeter. Follow the manufacturer’s recommended technique for making time measurements. whichever is greater.22 Labeling. For mobile mammography units.g.. The kVp meter should have been previously calibrated against a highvoltage divider on the type of generator that powers the mammography unit. and visual displays on the unit. Make measurements for both focal spots. Use a noninvasive timer to measure the accuracy of the time settings. it is acceptable for this test. Examples of indicators and displays are technique settings.. With all grounds lifted. no exposure if there is no film cassette in the Bucky) function. Confirm the presence and condition of accessories (e.. NFPA 99 calls for voltage measurements for installed devices in the patient vicinity. Instruct users to document activation of these alarms to ensure that they are functional. 4 Inspection and Preventive Maintenance System ©1995 ECRI. If a consistent significant error between the preset kVp and the measured kVp is detected. For units that have two focal spots. measure and record the voltage between a reference grounding point (e. and instruction cards are present and legible.3 2.20 Alarms. measurements should be made using each focal spot at the tube current setting appropriate for the focal spot in use. since some may require abnormal operating conditions (e. The resistance should not exceed 0. and cones).g.g. The chassis leakage current to ground should not exceed 300 µA. magnification platform. the grounding pin of an electrical receptacle or some other known ground) and exposed (i. source-to-image distance (SID). Measure at a minimum of three time settings spanning the range normally used at your facility..Inspection and Preventive Maintenance System meters. full and spot compression paddles. for filtration). further testing with a high-voltage divider may be required to identify the problem. Operate the device to activate any audible signals (for example. the measured kVp should be within ±5% of the preset kVp. filter in use. radiographic exposure). choice of focal spots.2 Leakage Current. 1. If the time settings are not displayed on the mammography unit. Check that all necessary certification labels.21 Audible Signals. Use the kVp meter in accordance with the recommendations of the meter’s manufacturer (e. check the method of reset (e.g. Check that any associated interlocks (e. measure and record the resistance between the ground pin (or the ground for hard-wired systems) and the accessible conductive surfaces on the mammography unit. diaphragms. Quantitative tests 2. If the unit has an alarm silence feature.g.g. breast thickness. Include checks of the light field in this test. The difference between the measured time and the preset time should not exceed ±1 msec or ±5% of the preset time.

a change in HVL may indicate tube deterioration. 28 kVp). simply mark the current average mR/mAs value on a trend chart together with values recorded at previous tests. chamber at same distance from focal spot.5 mm. 2. Collimate the beam so that only the sensitive area of the chamber is fully exposed. For the short-term test. These kVp. Previous HVL values should be compared with the current measurement. Calculate the mR/mAs for each exposure and average the calculations. same technique.6 Exposure Reproducibility.g. Set the mammography unit to operate at the kVp setting that would be commonly used to image a compressed breast 4 cm thick (e.8 Collimation. Each individual mR/mAs value should be within ±10% of the average mR/mAs value. On the larger film. Record the exposure values (in mR) from the electrometer or exposure meter for each exposure. Bring the Inspection and Preventive Maintenance System ©1995 ECRI. such that it extends beyond the patient edge of the cassette table by about 4 cm. The same criteria apply to all film sizes and for all collimators.5 Linearity of mAs. using a minimum of at least three mAs settings that span the range normally used.14). Use an ionization chamber with an electrometer (or a combination exposure meter) to measure the exposure in mR for this test. This test should be conducted with the compression paddle in place and at a kVp setting commonly used to image a compressed breast 4 cm thick so that the derived HVL may be used to calculate the average glandular dose (see Item 2. On the 18 cm × 24 cm film. The mR/mAs values should have a coefficient of variation no larger than 5%.g. same chamber-electrometer. Next. Place an 18 cm × 24 cm film cassette in the cassette tray. Use high-purity aluminum filters for this test. Dial up a midrange kVp setting (e.g.. 0 mm of aluminum).. place a fourth coin in the bottom left corner of the light field to provide orientation information. For long-term reproducibility.03] mm Al For example. Ensure that it covers the AEC detectors. Plot mR values against aluminum thickness on semilog paper (mR vertically on log scale). at 28 kVp.31 mm of aluminum. Then add aluminum filters in 0. 5 . (See Figure 1 for wire and coin placement. This is the HVL. ensure that no area beyond the outer edges of the coins can be seen on the film. The outer edges of the coins should mark the edges of the light field.9 AEC Object Thickness Compensation.7 Half-Value Layer (HVL). Then make an exposure and process both films. 2. Use one of the above mR/mAs values at 28 kVp as the one value to be used for evaluating short-term and long-term reproducibility of the mammography unit. It is critical that identical test conditions (e.) Record the SID in use on the mammography unit. Position the compression paddle as close as possible to the x-ray tube. turn on the light field and place one coin at each of the other three sides of the field defined by the light field. Long-term reproducibility should be within ±5% of the average. This distance should be no greater than 2% of the SID. measure the distance from the wire edge to the edge of the x-ray field. Position a 10 cm stiff wire on the larger film such that it is aligned with the patient edge of the cassette table. Finally.1 mm steps up to a total of 0.Mammography Units 2.. The devices should have been specifically calibrated using mammographic energy ranges. 2. mAs values should be held constant during the whole course of this test. Place a larger nonscreen film (24 cm × 30 cm) on top of the cassette table. Place 4 cm of 15 cm × 15 cm plexiglass on the cassette table. make a minimum of four exposures at the same mAs over a span of 15 minutes. Read the amount of aluminum thickness required to drop the initial mR value by 50%. The measured HVL should comply with the following equation: HVL ≥ [(kVp/100) + 0. 28 kVp). The ionization chamber should be placed centrally in the x-ray beam. with the compression paddle removed. roughly 4 cm in from the patient edge of the table. Record the initial exposure value (in mR) with nothing in the primary beam (i.e.1 mm addition. 2. Make radiographic exposures at this fixed kVp. absence of compression paddle) be maintained for accurate assessment of long-term reproducibility. Repeat this test for the 24 cm × 30 cm film size in the cassette table and for all collimators in use on the system. Select the mAs value that produces an exposure of around 500 mR with no added filters in the beam. Place the ionization chamber on the cassette table. Check this with the light field. and obtain an exposure reading for each 0. the HVL should be a minimum of 0. All Rights Reserved.. Note that this 2% criterion is valid only for the side that is adjacent to the patient’s chest.

Make an AEC-controlled exposure.4 OD. Place 4 cm of plexiglass on the cassette table. Collimation test setup 6 Inspection and Preventive Maintenance System ©1995 ECRI.g. 2. the film should be viewed on the viewbox normally used to display mammograms. Process the film on the standard film processor used to process all mammography films. use four kVp settings that span the range commonly used. or some other value that the radiologists have had programmed into the unit. Repeat this test using the magnification imaging mode on the mammography unit. Bring the compression paddle down to touch the top of the phantom. The same criteria apply. The optical density of all films at all kVp settings checked should agree to within ±0.3 OD of the optical density at 4 cm of plexiglass.3 OD. process the film on an optimally performing processor. Load a standard film-screen cassette into the cassette holder for all checks in this test. Repeat this test using the magnification imaging mode. 28 kVp). and three masses. having checked that it is performing optimally. having first ensured that it is performing optimally. Read the optical density of the phantom image using a densitometer. repeat the test using identical setup conditions but with varying amounts of plexiglass on the cassette table. The optical density of all processed films should agree to within ±0. Dial up 28 kVp on the mammography unit (or the kVp commonly used at your facility for this thickness of compressed breast) and acquire an image using an AEC-controlled exposure. Ensure that it covers the AEC detectors. All Rights Reserved. The optical density should measure in the range of 1. For each exposure at a given kVp. At a minimum. Load a standard screen-film cassette into the Bucky. Figure 1. Place the ACR accreditation test phantom on the cassette table. and for each check the film must be loaded into the same cassette for the whole test. Use the standard screen-film combination utilized at your facility as the receptor in the cassette holder. Set the mammography unit to operate at the commonly used kVp for imaging a compressed breast 4 cm thick (e. three speck clusters. Make a series of AEC-controlled exposures of the 4 cm thick plexiglass at different kVp values. check the optical density at 2 and 6 cm of plexiglass. All films used in this test should come from the same batch. Use a densitometer to measure the optical density of the phantom image at a point about 4 cm in from the edge of the phantom.13 Image Quality. Periodic checks should result in optical density changes within ±0.10 AEC kVp Compensation. Bring the compression paddle down to touch the top of the plexiglass stack. Once processed.2-1. 2.. It should be possible to see a minimum of four fibrils.1 OD. If the measured optical density falls within the acceptable range.Inspection and Preventive Maintenance System compression paddle down to touch the top of the stack. . Process the film using the standard film processor used for all mammography films. At a minimum.

38 0.42 0. Make an exposure of the phantom and record the mR value. ensuring that the phantom completely covers the sensitive area of the AEC detectors. Next.44 0.29 0.7).35 0.24 0. Lower the compression paddle so that it is just in contact with the chamber and the phantom.27 0.45 116 121 126 130 135 140 144 149 154 158 163 168 124 129 133 138 142 146 151 156 160 165 170 174 131 135 140 144 148 153 157 162 166 171 175 179 138 142 146 150 155 159 163 168 172 176 181 185 143 147 151 156 160 164 169 173 177 182 186 190 149 153 157 161 166 170 174 178 183 187 191 196 154 158 162 167 171 175 179 184 188 192 197 201 159 163 168 173 176 180 185 189 193 198 202 206 164 168 173 177 181 185 190 194 198 203 207 211 170 174 178 182 186 191 195 199 204 208 212 215 171 175 179 183 187 191 195 200 204 208 212 216 220 170 175 180 185 190 194 199 204 208 213 217 221 225 230 234 238 Source: American College of Radiology. If it is a Mo/Mo system Inspection and Preventive Maintenance System ©1995 ECRI.40 0. record the SID together with the technique settings.43 0. Secure the chamber in this position.28 0. 2.25 0.31 0.37 0. All Rights Reserved.33 0.23 0. The average glandular dose is determined by using the HVL value measured in Item 2. 7 .39 0.14 Average Glandular Dose to Standard Breast. the average glandular dose may be calculated as follows: a. Mammography quality control manual.34 0. To measure the entrance exposure.32 0.7 and the entrance exposure measured in this test. 1994:163.36 0.41 0. Using the HVL measured in Item 2.26 0.30 0. Glandular Dose (in mrad) for 1 Roentgen Entrance Exposure to a 4. Determine the target/filter combination of the system under test. This is the entrance exposure for the mammography phantom. place the phantom on the cassette table.Mammography Units TABLE 1. Make sure that the x-ray field completely envelops both the phantom and the ionization chamber. Revised ed.7 together with the entrance exposure measured in air for imaging the ACR mammography accreditation phantom. set the ionization chamber at one side of the phantom such that its center is 4 cm in from the patient edge of the cassette table and also vertically in alignment with the top of the accreditation phantom. and engage the AEC system. For a mammography system provided with a variable SID.2 cm Breast Thickness — 50% Adipose/50% Glandular Breast Tissue Using a Mo/Mo or W/Al Target Filter Combination X-Ray Tube Voltage (kVp) HVL 23 24 25 26 27 28 29 30 31 32 33 W/Al Target-Filter Combination 0. Set the mammography system at the kVp setting commonly used to image a compressed breast 4 cm thick (note that this kVp should match the value used for measuring the HVL in Item 2.

36 0.60 Source: American College of Radiology.45 0.58 0. Glandular Dose (in mrad) for 1 Roentgen Entrance Exposure to a 4. use Table 2 and Table 3. respectively.57 0. 25 149 154 158 163 167 171 176 180 185 189 193 198 202 206 211 215 220 224 26 151 156 160 164 169 173 178 181 186 190 194 199 203 207 211 216 220 224 228 27 154 158 162 166 171 175 179 183 187 191 196 200 204 208 212 217 221 225 229 233 238 28 159 162 166 171 176 179 183 187 191 196 200 204 208 212 217 221 225 229 233 238 242 29 30 31 32 33 34 35 163 167 171 176 180 184 188 192 197 201 205 209 213 218 222 226 230 234 239 243 247 167 172 176 180 185 188 193 197 201 205 209 213 218 222 226 231 235 240 243 247 251 172 176 180 185 189 193 197 202 206 210 214 219 223 227 231 235 240 244 248 252 257 261 177 181 186 190 194 198 202 207 211 215 219 223 227 232 236 241 244 248 253 257 261 265 269 181 187 191 195 199 203 208 212 216 220 224 228 233 237 241 245 249 254 258 262 266 270 275 279 191 195 199 203 208 212 216 220 224 228 233 237 242 245 250 254 258 263 267 271 276 280 284 288 200 204 208 212 217 221 225 229 234 238 242 246 251 255 259 264 268 272 276 281 285 289 293 or a W/Al system. 1994:164..53 0. d. For Mo/Rh and Rh/Rh systems. b.29 0.Inspection and Preventive Maintenance System TABLE 2.44 0.51 0.40 0. the dose that applies to an entrance exposure of 1 R).42 0.30 0.7.56 0. Progress along the row at this HVL until you are in the column headed by the kVp setting used to measure the entrance exposure in this test.e. Multiply the normalized glandular dose by the entrance exposure measured in this test.41 0. All Rights Reserved.43 0. 8 Inspection and Preventive Maintenance System ©1995 ECRI. .2 cm Breast Thickness — 50% Adipose/50% Glandular Breast Tissue Using a Mo/Rh Target Filter Combination X-Ray Tube Voltage (kVp) HVL 0.34 0.28 0.31 0.46 0.55 0. The value at the intersection of the HVL row and the kVp column is the normalized glandular dose (i.39 0. Mammography quality control manual. Go down the first column in the table until you find the HVL value measured in Item 2. Revised ed.37 0.49 0. c.47 0. The average glandular dose for the system under test should not exceed 300 mrad (3 mGy).48 0.32 0.59 0.54 0. The value obtained is the average glandular dose for the system under test.33 0. use Table 1.38 0.50 0.35 0.52 0.

Replace items on the unit.35 0.51 0. Inspection and Preventive Maintenance System ©1995 ECRI.52 0. if needed. Preventive maintenance 3.38 0.40 0.33 0. Multiplying the normalized dose by the entrance exposure of 0.30 0.57 0.. the HVL measured at 28 kVp was 0. 3.56 0.50 0.49 0.58 0.47 0.53 0. Glandular Dose (in mrad) for 1 Roentgen Entrance Exposure to a 4. if needed. Revised ed.46 0.3 3. Calibrate the unit. 9 .34 0.41 0.39 0.42 0. 3.45 0.28 0.4 4. 3.1 Clean exterior and interior.2 cm Breast Thickness — 50% Adipose/50% Glandular Breast Tissue Using a Rh/Rh Target Filter Combination X-Ray Tube Voltage (kVp) HVL 0.54 0.Mammography Units TABLE 3.29 0.5 R). if needed. the normalized glandular dose is 170 mrad.60 Source: American College of Radiology. Mammography quality control manual.31 0.48 0. 1994:165. All Rights Reserved.g.2 Lubricate according to the manufacturer’s instructions (e. 25 150 155 160 165 169 174 179 184 189 193 198 203 208 213 218 222 227 232 26 155 160 164 168 173 178 183 187 192 196 201 206 211 215 220 224 229 234 27 159 164 168 172 177 181 186 190 195 199 204 208 213 217 222 226 231 235 239 28 168 172 174 181 185 190 194 198 202 207 211 216 220 224 228 233 237 241 29 30 31 32 33 34 35 176 180 184 188 193 197 201 205 209 214 218 222 226 230 235 239 243 247 251 182 186 190 195 199 204 207 211 216 220 224 228 232 237 241 245 249 253 257 261 188 192 196 201 205 209 213 217 221 225 229 233 238 242 246 250 254 258 262 266 270 275 199 203 207 211 215 219 223 227 231 235 239 243 247 251 255 259 263 267 271 276 279 283 209 213 217 221 224 228 232 236 240 244 248 252 256 260 264 268 272 276 280 284 288 219 223 226 230 234 238 242 246 250 254 258 261 265 269 273 277 280 284 288 292 296 221 224 228 232 236 240 243 247 251 255 259 262 266 270 274 278 281 285 289 293 297 300 304 As an illustration of the above method. From Table 1.33 mm Al and that the entrance exposure measured at 28 kVp was 500 mR (0. if needed).36 0. Acceptance tests Acceptance testing is typically performed by a medical physicist.5 R provides the glandular dose value of 85 mrad.43 0. assume that on a Mo/Mo system.32 0.37 0.59 0.55 0.44 0. clean and lubricate casters.

Inspection and Preventive Maintenance System Before returning to use Ensure that all controls are set properly. Attach a Caution tag in a prominent position so that the user will be aware that control settings may have been changed. If the unit is being used at home. ensure that all controls are set correctly before it is returned to the patient. . 10 Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved. Set alarms loud enough to alert personnel in the area in which the device will be used. Other controls should be in their normal pre-use positions.

or purification systems. Mix-ups in medical gas connections have caused deaths. We are also aware of other cases in which similar incidents have occurred. problems can develop during the working lifetime of the systems. does not apply to medical air compressors. Standard for Health Care Facilities. particularly in medical compressed air systems.Procedure/Forms 440-0595 Medical Gas/Vacuum Systems Used For: Alarms. dryers. nonflammable medical gas systems. Piped gas systems present certain characteristic hazards. PA 19462-1298. Central Gas System [15-824] Medical Gas and Vacuum Systems [18-046] Medical Gas Outlets [17-682] Valves. Overview In an actual case. usually related to their original construction. Increasing the inspection interval up to but not more than two years is acceptable in these cases.. 250 outlets/day in unoccupied areas Same as above Minor Months * Although we recommend that a major inspection (Items 2. and nitrous oxide) and central vacuum system. 3. contaminant monitors. use and degradation of materials incompatible with the gases to be delivered. in at least 15 hospitals in North America. air. modification. workers renovating an emergency room inadvertently cross-connected the nitrous oxide and oxygen supply lines. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. 6. 7. 5. Section C-4. in the emergency room) are subject to wear.org . Where alarm-system test buttons are provided. does not replace full testing according to NFPA 99. Appendix C. 20 outlets labeled “oxygen” actually delivered nitrous oxide for more than six months before the hospital’s chief anesthesiologist discovered the error. 1994 Jan-Feb. and 8) be performed annually for medical gas and vacuum systems. vacuum systems Commonly Used In: Most patient care areas and some laboratories Scope: Applies to any piped medical gas system (including oxygen. The hazards include plumbing errors. outlets. as described above. audible and visual alarm indicators should be tested monthly (NFPA 99. and/or additions to the medical gas system 12 months* Interval Used By Hospital Months Time Required Approximately 100 outlets/day in occupied areas. and vacuum inlets.2. However. some frequently used outlets and inlets (e.g. Medical Gas and Vacuum [18-044] Also Called: Piped medical gas systems. As a result. and more frequent performance of Items 5 and 6 should be considered to ensure their safe operation. modifications.17). 241434 440-0595 A NONPROFIT AGENCY 5200 Butler Pike. we understand that. this may not be practical. including multiple fatalities in some institutions. for some hospitals. However. or repair. 23:4-41) Type Major ECRI-Recommended Interval After any renovations. medical-surgical gas systems. which must receive regular IPM for safe and reliable operation (see Medical gas and vacuum systems. Health Devices [Guidance article]. Plymouth Meeting. which must be conducted following any new construction or modification.

reference pressure of zero). Hospitals should also obtain documentation verifying the purity of medical gases from suppliers.1) and the blow-down (or initial purging) test (Section 4-5. the reference pressure to which the measuring device is calibrated. and the American Institute of Architects’ Guidelines for Construction and Equipment of Hospital and Medical Facilities.g..e.2. accurately.. the section on gas and vacuum systems.. The hospital should have the contractor who installs the system and an outside testing organization provide documentation of conformance * Pressure is measured relative to one of two reference points: standard atmospheric pressure (14. microorganisms. or dirt in medical compressed air pipelines). These activities may include replacing defective outlets or inlets. The procedures outlined in NFPA 99 are clearly intended to test newly constructed systems that have not yet been put into service. or respiratory therapy department may perform this testing. including fire and explosion. in its 1995 Accreditation Manual for Hospitals. construction of a building addition) are not included in this category..g.. and cross-connections (in addition to other items) and provides specific criteria for gas analysis and monitoring. and adding outlets to the existing system. an independent testing organization that specializes in this type of activity can be employed. Identification plates and other labels are often removed during this activity. anesthesia. and completely inspect only the modified portion of the system. NFPA 99 also calls for the healthcare facility to develop and implement procedures for testing medical gas and vacuum systems and their related alarm systems. (See Cleaning contaminated MGVSs. both the 150 psig pressure test (Section 4-5. between the gases and pipeline components or foreign matter. by dust or by body fluids). this documentation.g. The hospital’s facility engineering. NFPA 99. pressure gauges. this IPM procedure should satisfy this requirement for piping and alarm systems testing. unless otherwise specified. ECRI knows of no procedure other than this one that enables the hospital to safely.g. and maintenance of utility systems (e.) It specifies tests for zone-valve and alarm-system function. inspection.* Pressure testing and purging of the completed system must also be performed. easily. drugs) be prepared. clogged vacuum inlets and piping (e. Also. hydrocarbons. (In this procedure. leaks. Life Safety Code. are installed. and administered according to appropriate laws and standards of practice. that the piping systems must be tested following new construction. physically damaged or loose outlets. such as pressureactuating alarm switches. In a typical hospital. wear of compressor or pump seals and bearings. . requires that medications (i. air intake near diesel exhausts). the JCAHO manual. piped medical gas and vacuum systems are frequently repaired. 23:34-5. gas contamination by residual debris or accumulated foreign matter (e. Major changes to systems (e. as well as documentation from analytical tests. and gas contamination due to a contaminated source (e. which base design and safety requirements on NFPA 99. references to NFPA 99 refer to the 1993 edition. gas contamination due to chemical interaction. corrosion of automatic condensate drains. increasing the probability of error. or piping. in its section on medications. the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requires that the hospital have documented plans and procedures for routine testing. In addition. wear or embrittlement of valve seals. scale. the hospital should perform acceptance inspection and testing of the medical gas and vacuum systems independently of tests conducted by the installing contractor. Health Devices 1994 Jan-Feb.2.7 psia) or zero absolute pressure. valves. 2 Inspection and Preventive Maintenance System ©1995 ECRI. Also. addition. and pressure relief valves.. moisture. and psia refers to absolute pressure (i. relocating outlets. and expanded. independent testing of these systems before they are used for patient care is recommended. Installers are required to perform some testing of new or modified systems. All Rights Reserved.. and pressure sensor drift. experience.1. The process described by that standard requires testing at different stages of installation before proceeding with additional installation. For example.. typically standard atmospheric pressure). or repair. should be kept on permanent record. The JCAHO manual also indirectly refers to NFPA 99 through NFPA 101. Hospitals should insist that those responsible for construction document the test methods and results as required in NFPA 99. renovation. manifolds. medical gas and vacuum systems) to ensure that these systems operate properly and will continue to operate in an emergency. which again indirectly refers to NFPA 99.2) must be performed before system components.g. which is mandatory in some localities. modified. because medical gases are drugs. If adequate personnel.e. delivered. states in Chapter 4.Inspection and Preventive Maintenance System obstruction of flow by migration of material left in the pipelines. alarms.e. clinical engineering. or equipment is lacking. psig refers to gauge pressure (i.1.) Problems related to how the system is used and maintained during its lifetime include leaking outlet seals. inadequate particulate filtration. The standard also requires that proper medical gas concentration be verified and that the supply systems be tested after any breach of or modification to the system.

with 5% accuracy Inspection and Preventive Maintenance System ©1995 ECRI. Before testing. or system serving a patient or patient care area without the approval of clinical personnel. Never disconnect or test any medical gas outlet.g. Because of the difficulty and expense entailed and the possible compromise of patient care. failure to fully test systems can allow serious problems (e. All Rights Reserved. 1995 Mar. Color-coded compressed medical gas hose changes color [Hazard]. if a flowmeter calibrated for the gas being measured is not available. turn off zone valves.g. cylinders with regulators... Provide ample preparation time. Chapter 4.g. with 5% accuracy (flowmeter manufacturers usually supply calibration curves for a range of common gases with each instrument). 0 to 760 mm Hg). Also. such as screwdrivers. 24:127. Note: Medical gas systems may contain contaminants that may affect test instruments. and ensure that an adequate supply of appropriate gas cylinders and/or vacuum sources is available in the immediate area as a backup for piped gases. portable suction systems) and may need to minimize gas or vacuum usage (e. pressurize with another gas or to a pressure different Test Apparatus and Supplies Oxygen analyzer that will remain accurate in the presence of and not be damaged by nitrous oxide (analyzers used with anesthesia units are probably satisfactory) Vacuum measuring device. alert clinical personnel. such as “Do Not Use” and “System Under Test” Sampling bottles and filters for collecting samples for analysis. and pliers Labels. 1994 Jan-Feb. Pressure measuring devices. vacuum inlet. portable pneumatic calibrators or anesthesia machine calibrator/analyzers may be suitable alternatives. Thus. by rescheduling surgery) to test the entire medical gas or vacuum system following modifications. with 5% accuracy Flowmeter. ECRI has developed a simple technique that permits testing and inspection both of existing systems and of modified portions without affecting the entire hospital at once. especially if a system or zone must be shut down for testing. cross-connections. hospitals are reluctant to fully test modified systems. the hospital must provide a large number of alternative gas or vacuum sources (e. Do not perform any test that may interfere with the gas supply to patients (e. which are usually thought of as problems associated only with new systems) to go undetected. 0 to 250 L/min.Medical Gas/Vacuum Systems with all portions of NFPA 99. may be needed. 23:4-41. periodic cleaning. 3 .. wrenches (including Allen wrenches). except after major modifications or additions. 22:426-7. typically. Medical gas and vacuum systems [Guidance article].. for all new medical gas and vacuum system construction.g. However. Soldered medical gas piping [User Experience NetworkTM]. Source of oil-free dry nitrogen with a pressure regulator to supply a test gas (see the section on compressed gases in “IPM Safety” behind the Guidance Tab of this binder) Hoses and adapters to connect the pressure or vacuum measuring device and test gas cylinder to each gas outlet Hand tools. 1986 Apr. 0 to 30 inches of mercury (in Hg. these are obtained from the laboratory that will conduct the analysis Citations from Health Devices Restricted draw in Schrader-type vacuum inlets [User Experience NetworkTM]. 0 to 100 and 0 to 400 psig. in addition to calibration. use the following formula: Corrected Flow = Indicated Flow  Density (Design Gas) √ Density (Test Gas) Flow control valve(s) Test equipment that combines the functions of the above test devices or that automates the testing described in this procedure is available and may be substituted. alternatively. 23:310. 23:494-5. 15:106-7. 1994 Dec. 1993 Aug-Sep. Performing certain portions of the NFPA 99 testing procedure requires a complete shutdown of the system. Should vacuum pump effluent be treated? [User Experience NetworkTM]. Special Precautions General. this procedure also allows detection of most problems that can develop during system modification or system operation. 1994 Jul. Use of filters on medical gas system outlets and vacuum system inlets [User Experience NetworkTM].

Take special precautions when testing or purging nitrous oxide systems to minimize exposure to the exhausted gas. This may be a room. then open the zone valve and each outlet in the zone in order. It does not replace the full testing required by NFPA 99. You can turn off an outlet before opening the next outlet in the line.g. In smaller rooms with lower ventilation room-air exchange rates. has not been shown to be hazardous. with oxygen and medical compressed air pipelines). correspondingly shorter purge times can be used for shorter piping runs. use the special three-part Medical Gas and 4 Inspection and Preventive Maintenance System ©1995 ECRI.2.. Restrict unnecessary entry into the room during this time. purge the test gas from the system before using it for patients. and the alarm capabilities. will not detect nitrogen or nitrous oxide).1. use an oxygen analyzer to verify proper oxygen content at each outlet. be sure you understand how the gas system and associated equipment are intended to operate. the room may be used if essential for patient care. as required for certain sensors (e.Inspection and Preventive Maintenance System from the usual supply pressure) while that section of the system is in use for patients. Begin the inspection procedure by identifying the area to be tested. as in an operating room). Use a length of corrugated tubing (about one inch in diameter) to direct the exhausted gas away from personnel and. close that outlet. You must perform all items in the procedure on any portion of the system that is repaired or modified before that portion of the system is put into service. Because of high pressure. Do not allow smoking or other open sources of ignition in the immediate test area. All Rights Reserved. and leave the room after turning off the outlets. In a typical operating room. dissipation may require 1 hr. Include ceiling columns (e. Also. especially in the presence of nitrous oxide or oxygen.1. alarm switches. pressure test) — use only oil-free dry nitrogen. Because the Universal Inspection Form is not applicable.g. Nitrous Oxide. it confirms safe operation and is recommended for use by the hospital for independent confirmation of safety and performance only after the construction. this could damage the vacuum gauges. apply a test gas to) a vacuum system with gauges in the section of the system to be pressurized. 15 min is adequate. Although occasional acute exposure to nitrous oxide. If you are inspecting a system that is already in operation. Restrict personnel from entering the room to allow the exhausted gas to dissipate. and outlets in these systems. make certain that the adapter is securely locked into the outlet. and inspection per NFPA 99 have been completed and on an annual basis thereafter. After depressurization. into a ventilation return duct or out a window. take special care when inserting and disconnecting adapters from the outlet under test. For example: Women of childbearing age should not routinely perform this procedure or be in the area during the procedure. We recommend that each gas outlet be identified with a numbered label or an engraved number on the faceplate. we recommend that you still take reasonable precautions to minimize exposure. Where appropriate (e. such as delivery rooms. Procedure This procedure was developed to help hospitals find and correct hazards associated with existing and modified piped medical gas and vacuum systems. open an outlet to depressurize the system. or flush each outlet with its labeled gas for approximately 1 min (except nitrous oxide — see the precautions below — and also note that an oxygen analyzer.g.. . a special care area. Section 4-5. Disconnect equipment from each outlet before performing the inspection of that outlet station.. can also damage certain sensors. tests.. With the appropriate zone valve closed.) Purge the nitrous oxide system last. which might occur during annual testing.. carefully read this procedure. Before beginning the inspection. Overpressurizing compressed gas lines. starting with the outlet nearest the zone valve. consult clinical personnel before disconnecting any patient care equipment being used. Never pressurize (i. Certain pressure tests must be conducted before these components are installed in the system per NFPA 99. (About 200 ft of piping can be purged in this time. Never use oxygen as a test gas (e. before testing. Inspect every outlet at each station in the area. as well as surface-mounted stations. One systematic numbering method consists of starting to the left of a given doorway from a position facing into the room and proceeding clockwise. Each outlet at a given station is then numbered from left to right. Purging. by definition. newly installed or modified systems). or an area with many outlets. the significance of all controls and indicators. Limit purging and flow measurement times from each outlet to 10 sec.g. When using the test gas (oil-free dry nitrogen) to inspect an alarm panel or to pressurize a piping system. numbering the outlet stations in the room (see Figure 1).e. where practical.

) Check area signal panels. and make sure that an adequate alternative gas supply is available. On the appropriate part of the inspection form (on Parts A and B). pressurize the appropriate section of the medical gas or vacuum system to 100 psig with oil-free dry nitrogen. use the following formula: PFinal = PInitial × TFinal TInitial Figure 1. as required by NFPA 99 during the initial pressure test) for testing to reduce the risk of damaging system components. check the OK column after confirming the satisfactory condition and performance of that item. We recommend using 100 psig (instead of 150 psig.3. circle unacceptable values. this does not substitute for pressure testing according to NFPA 99 during installation. To test the low-pressure alarm.1. Inspection and Preventive Maintenance System ©1995 ECRI. close the appropriate zone valve. The individual who completes the repairs should record the date and his or her initials in the Action Taken column.7 to degrees Fahrenheit. record the test data and the actions needed and taken. (Verify that components [e. check both the Action Needed and the Do Not Use columns. (Note: This test can be performed in conjunction with Item 3.2 to degrees Celsius and 459. The Status box in the upper right corner of each form provides a quick indication of the condition of the outlets or alarms and valves listed. pressure sensors] will not be damaged by this test pressure. respectively. bleed system pressure with the zone valve closed until the low-pressure alarm is activated. Part A of the form is for alarm-panel and zone-valve inspections. After correcting for any temperature changes. label the outlet so that it will not be used and so that it can be quickly identified for future repairs. 5 . If the outlet is usable. inform clinical personnel. When all components of the system have been installed and the system is ready to be used. Area Pressure Alarms. Area pressure alarms should be activated when line pressure varies 20% from normal system pressure. and 18 outlets. and Part B is for medical gas outlet and vacuum inlet inspections. numbered clockwise from left. All new or modified systems should be pressure tested per NFPA 99.1 and 4-5.. On additions and modifications.g. Check the Passed box in the Status area only after all repairs for all items on that form are complete. and apply oil-free dry nitrogen through a pressure measuring device to one outlet in the zone until the alarm is activated. To correct for temperature changes. and appropriate gauges for proper * To obtain a temperature in kelvins or degrees Rankine. If the outlet is in an area being used.2. Vacuum System Inspection Form provided. Part C is for documenting medical gas purity analysis.1. Sections 4-5. close the appropriate zone valve before pressurizing so that the section to be tested is isolated from the rest of the system. We recommend that the following acceptance test be performed by the hospital or an independent agency before a new system or modified portion of the existing system is put into use. Measure and record the alarm activation pressures on the top portion of Part A of the Medical Gas/Vacuum Systems Inspection Form. Measure the pressure immediately after pressurization to 100 psig and again 1 hr later.Medical Gas/Vacuum Systems 1. where T = absolute temperature measured in kelvins or degrees Rankine* 2.) However. check only the Action Needed column. To clearly identify defective outlets on the inspection form. Sample room with 6 stations. Measure and record the alarm pressure. alarm. check the Service Required box. To test the high-pressure alarm. All Rights Reserved. Pressure Testing. Check the appropriate box after completing the inspection.2. or valve on the sheet requires servicing. confirm that there has been no change in line pressure after the 1 hr period. If even one outlet. If deficiencies detected during the inspection are serious enough to preclude using an outlet until it is repaired. remote indicators (if present). add 273. or note specific defects in the Comments section at the bottom of the form.

check each individual outlet of each gas and vacuum system to determine that test gas is not present at any outlet other than the one connected to the pressurized supply. Cross-Connection Testing.1. Section 4-5. cover plates. This will ensure that outlets are connected to and labeled for the appropriate gas system. With appropriate adapters (which should match outlet labels). Check that each outlet is properly labeled with the name of the dispensed gas and that its cover plate is securely fastened. gaskets) in the valve assembly. including labels. use the following procedure. carbon dioxide. Section 4-5. Ensure that color coding is consistent with standards for the gas supplied to each outlet (e.3.g. O-rings. and a flowmeter or pneumatic analyzer to the outlet. 4. Close the valve. Pressure at that outlet should not Table 1. and fittings.. see the precautions regarding nitrous oxide. Section 4-5. Listen for leaks before and after inserting adapters. 6 Inspection and Preventive Maintenance System ©1995 ECRI. Also check that a line-pressure gauge is present downstream of the zone valve and that it correctly reads the system pressure by comparing it with a pressure measuring device at an outlet in that area. nitrogen. Repeat this test by pressurizing each additional piping system.8. In addition. and reduce the first system to atmospheric pressure. Zone valves are tested to ensure that the branch served by the zone valve will be closed and isolated in the event of an emergency. 5. Examine the condition of the outlet. measure and record the flow and pressure at that flow on Part B of the Medical Gas/Vacuum System Inspection Form.3. Perform a leakage test on all threaded components of the pressurized zone valve using a test solution listed as safe for use with oxygen. Purge all tested systems in accordance with NFPA 99. Zone Valves. The test must be performed after all outlets are completely installed. Make sure that the adapter specific for the gas dispensed locks securely into the outlet.3. Disconnect all sources of test gas from all of the systems with the exception of the one system to be checked. retesting of audible and visual alarms should be done monthly. Medical Gas Outlets (medical compressed air. L/min ≥100 ≥100 ≥100 ≥100 ≥145 *Pressures and flows per NFPA 99. To avoid disrupting patient care when testing modifications to existing systems that are in use.g. .1.. Disconnect the source of the test gas. and other gases if piped). Open the flow-control valve until a flow of 100 L/min is seen. (Other testing may be completed with the test gas before purging.9. psig 50 to 55 50 to 55 50 to 55 50 to 55 ≥160 Flow. Recommended Pressures and Flows* Medical Gas Oxygen Nitrous Oxide Medical Air Carbon Dioxide Nitrogen Pressure. check signal panels for deactivation after returning the system to normal pressure. Recommended Pressures and Flows. yellow for medical compressed air). To test new systems or major modifications to existing systems where gas sources can be shut down without disrupting existing patient care. All Rights Reserved. Record findings on the bottom portion of Part A of the Medical Gas/Vacuum System Inspection Form. Do not rely on testing done before final attachment of labels and other identification plates that identify gas outlets. This test should only be performed on new systems or following any system modifications. oxygen. one at a time. Leaks may be corrected by replacing seals (e. and that the valve closes when the adapter is removed. Check each zone valve for a label or placard that lists the gas it controls and the area it serves. and bleed the branch to zero pressure. that the outlet does not leak with the adapter installed. Before placing the system in service. NFPA 99 requires that piping systems be able to deliver flows at the pressures listed in Table 1. Also check audible alarm-silence systems during alarm activation — a visual alarm light should remain on.1.9. a pressure measuring device. that the adapter is easily removed. and the special precautions noted previously. Confirm that the system gauge and pressure measuring device read zero.Inspection and Preventive Maintenance System labeling and function or accuracy. Reduce all pipelines to atmospheric pressure. 3. use the oxygen concentration measuring procedure described in Item 5. Pressurize this system to 50 psig with oil-free dry nitrogen to avoid disruption to and possible contamination of the existing services. nitrous oxide. including vacuum (unless gauges are present). purge it as described in the Special Precautions section and in accordance with NFPA 99.) If the alarm panel has test buttons. green for oxygen. Attach an oxygen analyzer.

by removing the inlet valve assembly and washing it in warm soapy water (see the section on infection control in “IPM Safety” behind the Guidance Tab in this binder). Note that. maintenance. depending on the severity of the restriction. which should not drop below 160 psig at a flow of at least 145 L/min. if necessary. Attach the vacuum measuring device to an inlet and a flowmeter to an adjacent inlet. it may be possible to attach an outlet or connector to the wrong hose. 6. nitrogen. we recommend noting the maximum flow.3. in an operating system. nitrogen will be at a higher pressure than nitrous oxide. Rinse the inlet valve assembly with clean water Inspection and Preventive Maintenance System ©1995 ECRI. Health Devices 1986 Apr. Blowing the piping clear with the outlet removed and cleaning the outlet check valve(s) will usually resolve this problem. All Rights Reserved. if the pressure drops to below 80% of the listed values in older systems or below the required values in newer systems or if the required flows cannot be obtained. However.g. Section 4-5. Section 4-11.. nitrous oxide. the two inlets be on the same branch and that the pressure be measured at an inlet beyond the inlet at which the flow is established. Be aware that the color of gas hoses can change over a period of time (see Color-coded compressed medical gas hose changes color [Hazard]. or replacement. In addition. NFPA 99. (Minimize exposure to nitrous oxide. the outlet may have to be replaced or. Unacceptable pressure or flow may indicate a blockage in either the distribution piping or the outlet check valve(s). Also consider whether simultaneous use of multiple outlets will further degrade performance.) If the above measures do not resolve the problem. In some hospitals. corrective action is required. 7 . Some older systems may not be able to meet these criteria. although such high flows may not be required for many applications.) Replace any hoses that have changed color or faded. Although the ceiling connector and suspended outlets may have proper labels and unique fittings for each gas to prevent incorrect connections. it is then necessary to determine whether corrective action (e. inspect the interior of each vacuum inlet for accumulated dust or other debris from leaking seals or poor suctioning procedures. Most newer systems will be able to provide 85 L/min at an inlet. Vacuum Inlets (vacuum and evacuation vacuum). DISS to quick-connect fittings) to minimize problems such as gas leaks at the connectors. a portion of the system may need to be modified. Measure and record (on Part B of the Medical Gas/Vacuum Systems Inspection Form) the oxygen concentration to determine that the outlet is delivering the proper medical gas. This test can also serve to check for cross-connection in existing systems.9.1. Avoid using special adapters for connecting hoses (e. make sure that the ceiling connector and outlet linked by a given hose have the same gas label. as described in Item 5. If you have such an installation. but for routine testing of installed systems. requires that the vacuum pressure be at least 12 in Hg (305 mm Hg) while 85 L/min (3 standard cubic feet per minute) flow is being drawn at an adjacent inlet. including the safe operation of life-support equipment. Some older systems may not be able to meet these requirements. Using a piece of tubing. cleaning the pipeline) is required to meet clinical needs. more accessible height. The oxygen concentration should be 100% at oxygen outlets and 21% at medical compressed air outlets.Medical Gas/Vacuum Systems drop below 50 psig for all gases except nitrogen. Color-coded hoses are recommended for this application to reduce the risk of misconnection. hoses extend from ceiling connectors to outlets that are suspended at a lower..3. ECRI can provide advice on the most appropriate action to take should a flow-restriction problem exist. NFPA 99. Measure and record the pressure and flow on Part B of the Medical Gas/Vacuum System Inspection Form.1. Gas hoses should have appropriate connectors for attachment to equipment. where practical. Recheck each time service personnel remove a hose for repair. We recommend that. Thus. Clean the inlet.g. 15:106-7. requires the use of gas-specific analyzers for initial testing of new and renovated systems. suck about a liter of the wash water into the disassembled inlet to clean debris from the inlet section of the pipeline. the end connections of the hoses and the pipelines to the gas fittings and outlets may be identical. This problem may also arise if you use extension hoses to connect equipment to a wall or ceiling outlet. and carbon dioxide outlets should read 0% on an oxygen analyzer. For inlets that have reduced vacuum draw. Consult with clinical staff to determine the minimum acceptable flow for clinical needs. see Special Precautions. Inspect the condition of each inlet.2.

take a sample at the farthest outlet locations from the compressor in the piped medical compressed air system.2 and Appendix C-4..9 of NFPA 99 requires periodic retesting of audible and visual alarms to determine whether they are functioning properly.1. sampling can be done at an outlet close to the source. and the contaminant itself will affect what should be done. All Rights Reserved. ECRI chose the values listed in the table because we believe they are reasonable to obtain and safe for the particular gas and contaminant based on our review of the several documents that define the composition of medical gases. Reciprocating (oil-less) compressors must also be monitored for liquid (continuously) and gaseous (quarterly) hydrocarbons. Determination of the source of the contamination will direct the course of corrective action (e. a clogged pipe). as well as for particulates and gas concentration. nitrous oxide.g. Remeasure vacuum pressure and flow at the cleaned inlet. Medical Gas Analysis. Refer to NFPA 99. A gas sampling port downstream of the system pressure regulators is used for this purpose. the sampling location. Refer to the manufacturer’s instructions for component testing. Judging the level of a particular contaminant relative to this table should be done with caution. Include the source of any certificate of purity and the date of the certificate. the sampling technique.g. verify that certificates of purity have been received and filed for each gas shipment. and carbon dioxide. Section 4-3. Compare the results to the values listed in Table 2. Obtain certificates of purity showing all testing performed by the gas manufacturer for each shipment of gas. requires that the quality of the medical compressed air generated on-site be monitored continuously for dew point and carbon monoxide.16 recommends annual testing of all components of warning systems if testing can be performed without changing system line pressure. to verify monitor performance. in which most allowable values meet or exceed the contaminant limits of most of the various concerned agencies. nitrogen. the piping system for these gases should also be tested for gaseous and liquid hydrocarbons. preferably in the summer when these contaminants are most prevalent. Inadequate flow may indicate other problems in the vacuum system (e. a second test. should be made to verify any suspected contamination. To determine the cause of any problem. 8 Inspection and Preventive Maintenance System ©1995 ECRI. For medical compressed air analysis. purge of pipeline). For annual inspections. obtain sampling bottles (as well as instructions for their use) from an analytical laboratory. for required components and recommended test intervals. Acceptance testing of medical gas purity is not usually required if purity testing required by NFPA 99 is conducted by an independent test organization when the system is completed. For all other analyses.1. Refer to Table 2 for recommended maximum allowable levels of contaminants for these gases. Enter the results of the medical air analysis on Part C of the inspection form. Master Alarm Panel. Section 4-6. For oxygen.2. . Section 4-4. After installation of a new system. and note this on the Confirmation of Purity section of the inspection form. We recommend taking gas samples from an outlet nearest the gas source and at the outlet most remote from the source. More frequent analyses may be warranted in hospitals with medical compressed air problems until those problems are resolved..9.Inspection and Preventive Maintenance System and reassemble the inlet.1. NFPA 99. change of source. Such factors as the measurement accuracy.8. 8. it may be necessary to monitor the quality of the outside air at the medical air compressor intake. Independent dew point and carbon monoxide tests should be conducted at least annually for all medical compressed air systems. Piped medical compressed air systems should also be tested annually for particulates.3. 7. independent of the first. Regardless.2. and Section C-4.

Medical Gas/Vacuum Systems Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved. 9 .

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.Inspection and Preventive Maintenance System 12 Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

Citations from Health Devices Mobile C-arm units [Evaluation]. 1990 Aug. 1993 Mar. foreign-body location. the industrial site. and brachytherapy. High. Mobile [11-758] Also Called: Portable C-arms. the operating room. interventional neuroradiology. the physician’s office. orthopedic. . They are used to image patients in radiolucent beds. 19: 251-91. or tables when it is not feasible to transport the patient to the radiology department. fracture reduction. and the athletic field. stretchers. These devices also enable special studies. critical care. FluoroScan Mini C-arm unit [Evaluation]. PA 19462-1298. hours hours Overview C-arms provide radiographic and fluoroscopic imaging in surgical. percutaneous lithotripsy. and neurological applications. The fluoroscopic feature allows real-time imaging. such as the diagnosis of swallowing disorders in patients who cannot readily sit on a standard fluoroscopic table or stand on a footboard. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. neurosurgery. hip replacement.Procedure/Checklist 463-0595 Mobile C-arms Used For: Radiographic/Fluoroscopic Units. Test apparatus and supplies Ground resistance ohmmeter Leakage current meter or electrical safety analyzer Noninvasive kVp meter (compatible with the x-ray generator being inspected) Noninvasive timer (may be included with kVp meter) Ionization chamber with electrometer or a combination exposure meter 241477 463-0595 A NONPROFIT AGENCY 5200 Butler Pike. Plymouth Meeting. cardiac. which permits quick diagnoses and minimal patient time under anesthesia during surgical procedures. Hospital Assessment. surgical C-arms Commonly Used In: Critical care areas. 1995 Feb. and operating rooms Scope: Applies to mobile C-arms capable of fluoroscopy and radiography Risk Level: ECRI Recommended. including aneurysm repair. Compact. C-arms are used in a variety of general surgical.org . The user can quickly acquire projections of the patient’s anatomy from various angles while continuously viewing the fluoroscopic images. Radiographic imaging capability may not be provided. 25:44-70. emergency departments. Mobile C-arms can also be equipped with a variety of digital hardware and software options for use in angioplasty. and emergency care procedures. Type Major Minor ECRI-Recommende Interval 12 months 6 months Interval Used By Hospital months months Time Required . 22:103-21. needle biopsy. International Medical Systems Exposcop Plus mobile C-arm system [Evaluation]. and trauma care. scaled-down fluoroscopic imaging systems called mini C-arms are designed for extremity imaging in the emergency room. pacemaker implantation. catheter placement.

with two sets of four holes of the following sizes: 1/16″. Wear rubber gloves or other appropriate protection when exposed to blood or other body fluids. and check that it is held firmly. verify the presence of line power. 3/16″. This procedure is intended to ensure adequate system performance and maintenance. carefully read this procedure and the manufacturer’s instructions and service manuals. 7 × 7″ (18 × 18 cm). Insert an AC plug into each receptacle. Keep x-ray exposure time to a minimum. if the damage is near one end. open the plug and inspect it. Ensure that caster brakes secure the stand from movement. 1/8″. the significance of each control and indicator. Shake the plug. 1. consider a full inspection of the receptacles. Check the ease of steering of the C-arm stand and the display cart. If the device has electrical receptacles for accessories.5 Line Cord.1 Chassis/Housing. Verify that the casters turn and swivel freely. cut out the defective Special precautions Wear a lead apron and thyroid shield at all times during x-ray exposure. if necessary.. and 7. 8 pieces of 30 × 30 × 2. or appropriate thickness of aluminum or copper) to bring the unit to midrange technique under automatic brightness stabilization (ABS) control Six pieces of 30 cm × 30 cm × 1 mm lead High-contrast resolution line-pair phantom to 5 lp/mm minimum Low-contrast phantom consisting of two 3/4″ (2 cm) aluminum plates. and listen for rattles that could indicate loose screws. wear lead gloves.3 Casters/Brakes.4 Procedure Before beginning an inspection. Ensure that high-voltage cables are completely discharged by repeatedly touching the conductor to ground as soon as it is removed from the well. 7 × 7″ (18 × 18 cm). and the alarm capabilities. Do not remove the high-voltage cables from the wells with the power on. ensure that the arm locks securely at each position.0. Qualitative tests 1. External collimators should be checked for pooling of blood and be cleaned. Such regulations and standards may include testing beyond that provided below and may also require documentation by a certified medical physicist. If damaged. 3. and one sheet of 1. if necessary. If accessories are plugged and unplugged often. Attempt to wiggle the blades to check that they are secure. replace the entire cord or. For repeated exposures. Also determine whether any special inspection or preventive 2 Inspection and Preventive Maintenance System ©1995 ECRI.0 mm) (using an alternative low-contrast phantom is acceptable provided that it can be reproducibly used for assessing long-term performance. Inspect the cord for signs of damage. The grid and image intensifier housing should be checked for blood and cleaned. rotation. 5. AC Plug/Receptacles. If any damage is suspected.g. Be sure that all hardware is present and tight and that there are no signs of spilled liquids or other serious abuse. All Rights Reserved. 1. Acceptance testing is crucial because it generates data on baseline performance of the device. It should not be necessary to place hands or fingers in the x-ray beam.0.5 cm plexiglass. and wig/wag. 1. Examine the AC power plug for damage. and 1/4″ (1. . Check the mechanical operation of the C-arm. Examine the exterior of all components of the C-arm for cleanliness and general physical condition. we strongly recommend contracting with a medical physicist. ensure that you understand how to operate the equipment.0. allow adequate time between exposures to prevent overheating of the x-ray tube.0 mm aluminum. including up/down motion. It should not be construed as providing full compliance with the requirements of all governmental regulations and accreditation standards of professional associations. 1.Inspection and Preventive Maintenance System Five filters of 10 cm × 10 cm × 1 mm Type 1100 aluminum Ruler with leaded 1 cm or 1⁄2″ markers Large-format x-ray film (30 cm × 30 cm) Patient simulator material (e. Maintain the greatest possible reasonable distance from the x-ray source and all scattering material. For acceptance testing. use the criterion applicable to the phantom selected) Oscilloscope (calibration only) High-voltage divider (calibration only of rotating anode type x-ray tubes) maintenance procedures or frequencies are recommended by the manufacturer. if unavoidable. ensuring that all movements are smooth.

collimation. check its value and type against that marked on the chassis. check their positions.g. 1. If audible alarms have been silenced or the volume set too low. 1. electrical safety analyzer. digital acquisition systems. make sure that no pins are missing and that the keying is correct. 3 . All Rights Reserved. video printers). Check that control knobs. secure mounting. meters. film cassette holder. long exposure times). check that it operates freely. the highvoltage cables should be removed from the wells. since some may require abnormal operating conditions (e. Confirm the presence and condition of accessories (e.20 Alarms. the control stand. confirm the operation of all lamps.21 Audible Signals. Examine all electrical cable connectors for general condition. manual or automatic) against the manufacturer’s specifications. Examine all controls and switches (x-ray initiation.g.. Verify that there are no intermittent faults by flexing cables for the display near each end and looking for erratic operation. and image storage numbers. Where a control should operate against fixed-limit stops. Confirm appropriate volume.13 Controls/Switches. image modes. The footswitch does not need to be grounded if it operates from low voltages. If keyed connectors are used.. We recommend a maximum resistance of 0. It may not be possible to check out all alarms at this time.. Induce conditions to activate audible and visual alarms (e. 1. as well as positive stopping. display monitor text. warning labels. adjust alarm volume to the appropriate level. 1. Carefully examine cables to detect breaks in the insulation and to ensure that they are gripped securely in the connectors at each end to prevent rotation or other strain. reinserted. If the device has an external circuit breaker. Be sure to wire a new power cord or plug with correct polarity. Operate the device to activate any audible signals (e. x-rays on. Ensure that the remaining length is adequate. technique charts. have not slipped on their shafts. and visual displays on the unit.g. measure and record the resistance between common ground and exposed metal on the C-arm. consider the possibility of inappropriate clinical use or of incipient device failure.7 1. x-rays on). For units with rotating anode tubes..) for physical condition. check the method of reset (e. between the C-arm stand and display cart.g.9 2.. Be sure that they hold the cord securely. Quantitative tests 2. Verify that leads and electrodes are firmly gripped in their appropriate connectors.. if present. Instruct users to document activation of these alarms to ensure that they are functional. Cables.18 Indicators/Displays. Electrical contact pins or surfaces should be straight. or multimeter with good resolution of fractional ohms. and tightened securely.g. ensure that they do not stick and that continuous pressure is required to continue exposure. Circuit Breaker/Fuse. Inspection and Preventive Maintenance System ©1995 ECRI. 1.10 Fittings/Connectors.. be sure to check that each control and switch performs its proper function. from the C-arm. check for proper alignment. and the display cart. indicators. clean. During the course of the inspection. If any setting appears inordinate (e. technique selection.22 Labeling.g. image manipulation. Using an ohmmeter. fluoroscopy inhibition) function. size of image. and bright. If the unit has an alarm silence feature. boost or high-level control fluoroscopy). high mA setting). Before changing any controls or alarm limits.23 Accessories. connecting the footswitch) and their strain reliefs for general condition. Release of pressure should immediately terminate exposure.6 Strain Reliefs. multiformat cameras.Mobile C-arms portion. If the device is protected by an external fuse. For the fluoroscopic and radiographic exposure switches. coated with high-voltage compound. Inspect any cables (e. gauges.g. 1. Examples of indicators and displays are technique settings. Check that all necessary certification labels. fluoroscopic exposure time. Examine the strain reliefs at both ends of the line cord. 1.1 Grounding Resistance.. and the ends and the wells should be cleaned.5 Ω.g. During the course of the inspection. 1. Check that any associated interlocks (e. etc. and instruction cards are present and legible. Record the settings of those controls that should be returned to their original positions following the inspection. and correct motion. 1. radiographic exposure. and ensure that a spare is provided.

record the maximum leakage current. Use an ionization chamber with an electrometer (or a combination exposure meter) to measure the exposure in mR for this test. provided that a documented maintenance schedule is established to ensure grounding integrity.Inspection and Preventive Maintenance System 2. Accuracy of kVp. Set the C-arm to operate in the radiographic mode at 80 kVp.g. Once the unit has been appropriately set up. It is critical that identical test conditions be used for assessing reproducibility. Under fluoroscopic guidance. and average the calculations.3 2. 2. The mobile C-arm may have a display only of mAs rather than exposure time.) Take measurements in the radiographic and fluoroscopic modes of operation of the C-arm at low. Most noninvasive kVp meters also display exposure times. Exposure Reproducibility. and Type 1100 aluminum filters for this test. Conduct measurements at typically used low. For long-term reproducibility. Place the ionization chamber on the image intensifier or at about 60 cm from the focal spot. 2. If a consistent significant error between the preset kVp and the measured kVp is detected. consult the C-arm manuals to find out what mA is being used at 70 kVp in the radiographic mode. For the short-term test. Long-term reproducibility should be within ±10% of the average. 70 kVp). (These may include the kind of filters to use and the distance at which the kVp meter has to be placed.g. 60. 80. simply record the current average mR/mAs value from the four values above and compare this with the value recorded during the preceding inspection. Use a noninvasive timer to measure the accuracy of the timer settings available on the C-arm system when it is operated in the radiographic mode. As a general rule. mAs) should be the same. Cover the image intensifier with 6 mm thick lead plate to protect the image intensifier and TV camera system. 80 kVp) with the C-arm set to operate in the radiographic mode. Dial up a midrange kVp setting (e. Some meters require that the user specify the type of generator being tested and the amount of filtration present in the primary x-ray beam. The mR/mAs value should have a coefficient of variation no larger than 10%. make a minimum of four exposures at the same mAs over a span of approximately 15 minutes. Calculate the mR/mAs at each setting. 2. For example. Follow the manufacturer’s recommended technique for making time measurements. for filtration).g. Make radiographic exposures at this fixed kVp. and record the exposure values (in mR) from the electrometer or exposure meter at a minimum of three settings that span the range typically used. dial up a midrange kVp setting (e. Use a noninvasive kVp meter that has previously been calibrated against a high-voltage divider on the type of generator that powers the C-arm system. during exposure. All Rights Reserved.g.. and 100 kVp). Each individual mR/mAs value should be within 10% of the average. Use an ionization chamber. but may be adjusted depending on intensity of use and previous experience. The exposure time readings can then be 2. Use the kVp meter in accordance with the recommendations of the manufacturer of the kVp meter. For older Carms.5 Linearity of mAs. and the technique (kVp. If this is the case. including on. and off. Operate the device in all normal modes. Select a midrange mAs value. Half-Value Layer (HVL). The ionization chamber should be placed centrally in the x-ray beam.. and high settings (e. . leakage current up to 500 µA is acceptable. whichever is greater. the difference between the measured time and the preset time should not exceed 1 ms or 5%..4 Timer Accuracy. standby.. the same chamber-to-source distance should be used.7 4 Inspection and Preventive Maintenance System ©1995 ECRI. and high time settings. a three-month interval is a nominal period. adjust the collimation on the C-arm so that the x-ray field just encompasses the ionization chamber. The image intensifier should be covered with a lead plate to protect it from excessive radiation. further testing with a high-voltage divider may be required to identify the problem. medium. Chassis leakage current should be 300 µA or less. medium.2 Leakage Current. Use one of the above mR/mAs values as the one value to be used for evaluating short-term and long-term reproducibility of the x-ray tube and the generator combination. After the appropriate corrections have been applied to the measured kVp readings (e. electrometer. the difference between the measured kVp and the preset kVp should not exceed 5% of the preset kVp. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened.6 calculated from the mAs values.

For units that have only manually selectable kVp and mA settings. ensure that the dimensions of the x-ray beam measured on the film do not differ from the dimensions of the fluoroscopic image measured with the lead ruler by more than 3% of the source-to-image distance (SID). 2. this test also verifies functioning of the ABS system.11 Standard Fluoroscopic Exposure Rate. Place the line-pair phantom on the grid. Place the chamber or the meter 30 cm above the image intensifier input plane. Low-Contrast Resolution. All Rights Reserved. 2.Mobile C-arms These kVp and mAs values should be held constant during the whole course of this test.12 Maximum Fluoroscopic Exposure Rate.. Place the low-contrast phantom on the grid. since a change in HVL may indicate tube deterioration. Place a ruler with leaded 1 cm or 1/2″ markers on the image intensifier housing.. for devices manufactured in 1996 and after. Record the initial exposure value (in mR) with nothing in the primary beam (i. There are no governmental regulations that limit exposure rates under boost mode for devices in use now. The typical exposure rate is 1 R/min (with a range of 0. 0 mm of aluminum). The thickness of aluminum required to reduce the initial exposure reading by half is the half-value layer of the beam. the HVL should be a minimum of 2. High-Contrast Resolution. Resolution should be at or above 1. In addition to verifying that the unit meets exposure requirements. 2. At low kVp (ABS with nothing other than the line-pair phantom in the field). Place a thick lead plate (at least 6 mm thick) over the image intensifier housing. Place the ionization chamber 30 cm above the image intensifier input plane. If the exposure rate has increased from that of previous inspections. Plot the exposure values on the logarithmic scale against the thickness of aluminum on the linear scale. For units that have automatic kVp and mA control. further testing should be performed to determine the reason for the required increase in radiation.3 mm of aluminum. It may be necessary to alter the brightness and contrast settings on the TV monitor to optimize the display for the visualized object. If the C-arm also has a “boost” or “high-level” control mode. Use an ionization chamber with an electrometer (or a combination exposure meter) capable of measuring exposure rate. Check for consistency of the exposure rate with those made during previous Inspection and Preventive Maintenance System ©1995 ECRI. the exposure rate should not exceed 10 R/min.7 lp/mm for a 15 cm (6″) FOV. After the film has been processed. Use an ionization chamber with an electrometer (or a combination exposure meter) capable of measuring exposure rate. Place sufficient patient simulator material on the image intensifier that the technique tracks to about midrange (e.e. It should be placed at a 45-degree angle to the grid lines and raster lines of the TV system. However. 70 kVp) in the automatic fluoroscopic mode. record the exposure rate during a fluoroscopic exposure in this mode. Ensure that the 1 mm piece of aluminum is next to the grid. determine the maximum line-pair resolution for all available field sizes. The thicker aluminum pieces should be on top of the 1 mm 2.13 Image Quality. place a large-format x-ray film (30 cm by 30 cm minimum) on the image intensifier housing and make a fluoroscopic exposure. Record the exposure rate on the electrometer or exposure meter during a fluoroscopic exposure in the automatic mode.8 Collimation. Then record the exposure reading with aluminum thickness of 2 mm and 4 mm.2 lp/mm for a 22 cm (9″) field of view (FOV) and 1.5 to 2. The HVL is most accurately read by plotting the measurements on semilog graphing paper. the exposure rate in the boost or high-level control mode should not exceed 20 R/min. inspections. Next. the exposure rate at the highest settings should not exceed 5 R/min. Run a fluoroscopic exposure. 5 . and measure the visual field size (length and width) of the image intensifier on the display monitor during a fluoroscopic exposure using the largest available mode on the image intensifier.g. still using the largest available mode on the image intensifier. Ensure that the whole input face of the image intensifier is covered by the lead plate.0 R/min). At 80 kVp. The HVL measurement should be compared to measurements from previous inspections. and record the exposure rate. A fluoroscopic exposure of about five seconds is likely to provide sufficient film darkening. as well as in the manual mode at the highest technique.

It may be necessary to alter the brightness and contrast settings on the TV monitor to optimize the display for the visualized object. 3. . if needed.Inspection and Preventive Maintenance System thick plate. Lubricate per the manufacturer’s instructions.3 Clean the exterior. Preventive Maintenance 3. Set alarms loud enough to alert personnel in the area in which the device will be used. All Rights Reserved. Before returning to use Ensure that all controls are set properly. Adjust caster brakes and arm locks. as well as the interior if needed.2 3. 6 Inspection and Preventive Maintenance System ©1995 ECRI. Other controls should be in their normal pre-use positions. the three smallest holes should be visible. On the 15 cm (6″) FOV. Calibrate per the manufacturer’s instructions. Initiate a fluoroscopic exposure under ABS control. Attach a Caution tag in a prominent position so that the user will be aware that control settings may have been changed.1 3. Acceptance Tests Acceptance testing is typically performed by a medical physicist. 4.

Because of design constraints. Filters are placed in the path of the x-ray beam to absorb the less penetrating x-rays. the capacitor(s) must be recharged. but the kV will decrease during exposure as the capacitor discharges. and a film cassette storage drawer. the overall image quality is lower. These units consist of an x-ray generator.Procedure/Checklist 468-0595 Mobile X-ray Units Used For: Radiographic Units. A step-up transformer increases the voltage. and self-propelled units contain a motor drive. Line-powered transformers use 120 or 220 VAC for x-ray production. Therefore. High. Battery-powered generators supply a constant kV and current throughout the exposure. The x-ray tube assembly. Mobile [13-272] Also Called: Mobile radiographic systems. surgical suites Scope: Applies to portable radiographic systems powered from or charged by a standard 115 VAC receptacle Risk Level: ECRI Recommended. each exposure begins at the same peak kilovoltage (kVp). which are then discharged through a grid-controlled x-ray tube. radiographs taken with mobile units are usually of poorer quality. a set of collimators confines the primary beam to the size and shape that will cover the area of diagnostic interest. At the end of each exposure. After the beam passes through the filters. PA 19462-1298. hours hours Overview Mobile x-ray units are used for radiographic imaging of patients who cannot be moved to the radiology department and who are in areas. In a capacitor-discharge generator. which includes the x-ray tube and collimator. Batterypowered units also contain a battery and charging system. a capacitor-discharge generator. One of three different types of x-ray generators can be used: a line-powered transformer. as well. line power is used to charge lead-acid batteries. an x-ray tube and tubestand. that lack standard. The x-ray tube anode is either stationary or rotating. such as intensive care units or emergency rooms. and a rectifier converts the AC to the DC required by the x-ray tube. is attached to a tubestand that can be rotated about its base or moved horizontally and vertically. portable x-ray machines Commonly Used In: Patient rooms. the radiology department. In a battery-powered generator. tube current in mobile units is often lower than in stationary radiographic systems. the output is then rectified and used to charge a large capacitor or group of capacitors. or a battery-powered transformer. Furthermore. Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . fixed radiographic equipment. 110 or 220 VAC power is fed into a step-up transformer. with 241473 468-0595 A NONPROFIT AGENCY 5200 Butler Pike. because patient positioning and film placement are more difficult with bedside radiography. Hospital Assessment. . the fully charged unit can then be operated independently of an outside power source until the batteries need to be recharged.org . Plymouth Meeting. collimators. Because the capacitors are charged to the same potential. Mobile radiographic units are designed for use only when patient transport is contraindicated. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri.

Maintain the greatest possible reasonable distance from the x-ray source and all scattering material during all x-ray exposures. Allow adequate time between repeated exposures to prevent overheating of the x-ray tube. dents. carefully read this procedure and the manufacturer’s instruction and service manuals. Ensure that high-voltage cables are completely discharged by repeatedly touching the conductor to ground as soon as it is removed from the well. ensuring that all movements are smooth with no binding or undue resistance. x-ray tube support. and that there are no signs of spilled liquids. and collimator. and collimator. AC Plug/Receptacles. as well as all movements of the x-ray tube. or other serious abuse. Qualitative tests 1. . and the alarm capabilities. offers a more controlled. if the damage is near one end. cut out the defective portion. Be sure that all hardware is present and tight. 1. Do not remove the high-voltage cables from the wells with the power on. It should not be construed as providing full compliance with the requirements of all governmental regulations and accreditation standards of professional associations.Inspection and Preventive Maintenance System fixedradiographic equipment. Look for accumulations of dirt and grime around the casters. open the plug and inspect it. Examine the exterior of all components of the portable x-ray unit for cleanliness and general physical condition. Examine the AC power plug for damage and ensure that the AC plug is clamped securely to the line cord. Also determine whether any special inspection or preventive 1. ensure that you understand how to operate the equipment. If this is unavoidable. Attempt to wiggle the blades to check that they are secure. caution users against this practice.1 Chassis/Housing. For acceptance testing. Be sure to wire a new power cord or plug with correct polarity. the significance of each control and indicator. we strongly recommend using a medical physicist. Inspect the cord for signs of damage. Check the brake or locking device for each movement of the x-ray tube. Shake the plug and listen for rattles that could indicate loose screws. wear lead gloves.3 1. optimal setting for imaging. Wear rubber gloves or other appropriate protection when exposed to blood or other body fluids. Check the ease of steering. Casters/Brakes. x-ray tube support. Ensure that the remaining length is adequate. maintenance procedures or frequencies are recommended by the manufacturer. This procedure is intended to ensure adequate system performance and maintenance. Check the mechanical operation of all moving parts to include any film storage compartment.4 Procedure Before beginning an inspection. Verify that the casters turn and swivel freely.5 2 Inspection and Preventive Maintenance System ©1995 ECRI. Acceptance testing is crucial because it generates data on baseline performance of the device. Special precautions Wear a lead apron and thyroid shield. replace the entire cord or. Such regulations and standards may include testing beyond that provided below and may also require documentation by a certified medical physicist. Line Cord. Test apparatus and supplies Ground resistance ohmmeter Leakage current meter or electrical safety analyzer Noninvasive kVp meter (compatible with the x-ray generator being inspected) Noninvasive timer (may be included with the kVp meter) Ionization chamber with electrometer or a combination exposure meter Five filters of 10 cm × 10 cm × 1 mm Type 1100 aluminum Collimator alignment template marked in centimeters or inches Medium-format x-ray film (25 cm × 30 cm or 10″ × 12″) Ten pieces of 30 cm × 30 cm × 2. If any damage is suspected. All Rights Reserved.5 cm plexiglass (or another patient-simulating material for testing the automatic exposure control [AEC]) Densitometer Oscilloscope (calibration only) High-voltage divider (calibration only) 1. deep scratches. If damaged. It should not be necessary to place hands or fingers in the x-ray beam. Ensure that all locks function properly and hold securely. If you find evidence that the plug is being removed from the receptacle by pulling on the cord.

. For cables other than high-voltage cables. if present.Mobile X-ray Units 1. Instruct users to document activation of these alarms to ensure that they are functional. etc. Ensure that the drive system operates smoothly. adjust alarm volume to the appropriate level. Check that any associated interlocks (e. Verify that the battery charger automatically stops charging when the appropriate state of charge is reached.10 Fittings/Connectors. check its value and type against that marked on the chassis and ensure that a spare is provided. and visual displays on the unit. Using a multimeter. be sure to check that each control and switch performs its proper function. Ensure that any cooling or ventilation fans operate properly. If the device is protected by an external fuse. Record the setting of those controls that should be returned to their original positions following the inspection. Confirm appropriate volume. If keyed connectors are used. warning labels.. squeaking). coated with high-voltage compound.. 1. and tightened securely. 3 . technique charts. and that release of pressure immediately terminates exposure. All Rights Reserved. Ensure that it is present.g. Check the condition of any air filters present in the systems.) Verify that the level of charge is accurately represented by the level-of-charge indicator on the operator’s panel. If the device has an external circuit breaker. gauges. (Consult the manufacturer’s documentation for appropriate measuring points. meters. collimation. Ensure that radiographic exposure switches do not Inspection and Preventive Maintenance System ©1995 ECRI. verify that there are no intermittent faults by flexing electrical cables near each end and looking for erratic operation. check their positions. since some may require abnormal operating conditions.7 1.13 Controls/Switches. indicators. and instruction cards are present and legible. and x-ray on. 1. audible signal during motorized drive if applicable). Induce conditions to activate audible and visual alarms (e. measure the battery voltage. Circuit Breaker/Fuse. manual or automatic) against the manufacturer’s specifications. During the inspection. x-ray tube park) function. and bright. It may not be possible to check out all alarms at this time.20 Alarms.. consider the possibility of inappropriate clinical use or of incipient device failure. radiographic exposure. 1. clean.. have not slipped on their shafts. Examine the strain reliefs at both ends of the line cord. Carefully examine cables to detect breaks in the insulation and to ensure that they are gripped securely in the connectors at each end to prevent rotation or other strain.23 Accessories. technique selection. check the method of reset (e.18 Indicators/Displays.e. check that it operates freely. Be sure that they hold the cord securely. Check that all necessary certification labels. does not pull to one side or the other. reinserted. High-voltage cables should be removed from the wells (at the x-ray tube ends). 1. 1. exposure time. x-ray on).24 Drive Mechanism (for motor-powered units only). if present.. If there are variable-speed controls 1.. 1. ensure that the x-ray exposure is not released by the first trigger only). Use an ohmmeter if a problem is suspected. high mA setting). and correct motion. 1.g. If the unit has an alarm silence feature. check for proper alignment. Inspect the source-to-image distance (SID) indicator (usually a tape measure). and makes no unusual noises (e. Examples of indicators and displays are technique settings.12 Filters.g.9 1. apparent binding. Operate the device to activate any audible signals (e. Electrical contact pins or surfaces should be straight. collimator cables.g. Ensure the proper operation of the two-position exposure switch (i.g. 1. as well as positive stopping. Examine all electrical cable connectors for general condition. make sure that no pins are missing and that keying is correct. Examine all controls and switches (x-ray initiation. high-voltage cables) and their strain reliefs for general condition. stick. film cassette holder). secure mounting. operates smoothly.g. Where a control should operate against fixed-limit stops.g. Check that control knobs.) for physical condition. cleaned.21 Audible Signals. that continuous pressure is required to continue exposure.g. Before changing any controls or alarm limits.17 Battery/Charger. If any settings appear inordinate (e. During the inspection. Cables. If audible alarms have been silenced or the volume set too low. confirm the operation of all lamps.. The high-voltage transformer end should not require routine inspection if the wells are vertical and high-voltage oil is used.. Inspect any cables (e. Clean or replace as needed. Confirm the presence and condition of accessories (e.6 Strain Reliefs. 1. and is accurate.22 Labeling.

Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. exposure. that the main drive handle must be depressed or squeezed to allow movement). Follow the manufacturer’s recommended technique for making time measurements. Make radiographic exposures at this fixed kVp and record the exposure values (in mR) from the electrometer or exposure meter at a minimum of three mA settings that span the range commonly used for a generator with variable mA. 100 cm). For example. The ionization chamber should be placed centrally in the x-ray beam at a known standard distance from the focal spot (e.Inspection and Preventive Maintenance System present. been appropriately set up. Use an ionization chamber. Long-term reproducibility should be within ±10% of the average. Use a noninvasive kVp meter that has previously been calibrated against a highvoltage divider on the type of generator that powers the portable x-ray unit. Use the meter in accordance with the manufacturer’s recommendations. Half-Value Layer (HVL). consult the instruction and service manuals to find out what mA is being used at 80 kVp. 100 kVp). Conduct measurements at typical low. The unit may have a display only of mAs rather than exposure time. All Rights Reserved.5 Linearity of mAs.2 2. make a minimum of four exposures at the same mAs over a span of 15 minutes. for filtration). Exposure Reproducibility. Quantitative tests 2. 80 kVp). Dial up a midrange kVp setting (e. Accuracy of kVp. including on. provided that a documented maintenance schedule is established to ensure grounding integrity. standby. measure and record the resistance between common ground and exposed metal on the portable x-ray unit.. the same chamber-to-source distance should be used. Also use three mAs settings for constant mA generators. test their operation.g. Place the ionization chamber in the center of the x-ray beam at about 100 cm from the focal spot.g. (These may include the kind of filters to use and the distance at which the kVp meter has to be placed.. Verify that the bumper switches disable the drive circuitry for both forward and reverse motions. It is critical that identical test conditions be used for assessing reproducibility. Verify that any interlocks associated with the drive circuitry are functional (e. 80 kVp). Use a noninvasive timer to measure the accuracy of the time settings available on the unit when it is operated in the radiographic mode. For long-term reproducibility. simply record the current average mR/mAs value. Use an ionization chamber with an electrometer (or a combination exposure meter) to measure the exposure in mR for this test. Using an ohmmeter. Once the unit has 2.7 2.4 4 Inspection and Preventive Maintenance System ©1995 ECRI. and high settings. Most noninvasive kVp meters also display exposure times. Each individual mR/mAs value should be within 10% of the average. whichever is greater. electrometer.. up to 500 µA is acceptable. mAs values should be held constant during the whole 2.) Make measurements at low. . The mR/mAs values should have a coefficient of variation no larger than 10%.g.g. For the short-term test. The difference between the measured time and the preset time should not exceed ±1 msec or ±5%. Collimate so that the x-ray field just encompasses the ionization chamber. Operate the device in all normal modes. that an x-ray tube not in park position allows slow drive only. After the appropriate corrections have been applied to the measured kVp readings (e. 60. and record the maximum leakage current. the difference between the measured kVp and the preset kVp should not exceed ±5% of the preset kVp.. and high settings (e. and compare it with the value recorded during the preceding inspection. medium. electrical safety analyzer. or multimeter with good resolution of fractional ohms. Some meters require that the user specify the type of generator being tested and the amount of filtration present in the primary x-ray beam.6 2. Leakage Current. The exposure time readings can then be calculated from the mAs values. 80. and off. and Type 1100 aluminum filters for this test.3 2. and the technique (kVp. Timer Accuracy.. For older portable x-ray units. mAs) should be the same..g.g. These kVp. If this is the case.1 Grounding Resistance. Chassis leakage current should be 300 µA or less. Set the unit to operate at 80 kVp. but may be adjusted depending on the intensity of use and on previous experience.5 Ω. three months is an acceptable interval. Select a midrange mAs value. Use one of the above mR/mAs values as the one value to be used for evaluating short-term and long-term reproducibility of exposure. dial up a midrange kVp setting (e. medium. 2. Calculate the mR/mAs at each setting and average the calculations. We recommend a maximum resistance of 0.

Compare the actual size of the exposed area to the readout of the exposure area size indicators noted earlier. See Figure 1. spot-film. 2. Place 20 cm of 30 cm × 30 cm plexiglass on the table or support it up against the wall Bucky. the misalignment should not exceed 2 cm. Measure the distances L1. Plot the exposure values on the logarithmic scale against the thickness of aluminum on the linear scale. Then record the exposure reading with aluminum thicknesses of 2 mm and 4 mm. Place a medium-format x-ray film (25 cm × 30 cm or 10″ × 12″). wall Bucky). At 80 kVp. The HVL measurement should be compared to measurements from previous inspections since a change in HVL may indicate tube deterioration.g.3 mm of aluminum. Ensure that the light beam is exactly centered on the collimator alignment tool. at an SID of 100 cm (40″). W1. The dimensions of the exposed area must be within 2% of the SID — that is. table Bucky. AEC Object Thickness Compensation (for units provided with an AEC system). 0 mm of aluminum).Mobile X-ray Units course of this test. a technique of 55 kVp and 5 mAs should be sufficient). ″ ″ Figure 1. that is. Precisely center the collimator alignment tool on the cassette.e. The thickness of aluminum required to reduce the initial exposure reading by half is the HVL of the beam. Process the film on a processor that has previously been verified as operating optimally. Schematic showing misalignment of the light field with respect to the x-ray field Inspection and Preventive Maintenance System ©1995 ECRI. such as aluminum. Ensure that the x-ray film is perpendicular to the x-ray beam. 5 . Note the exact readout of the exposure area size indicators.9 the processed film. This sum must not exceed 2% of the SID.8 Collimation. and place this into the receptor holder being tested. Congruence of the light field to the x-ray field. The sum of W1 + W2 + L1 + L2 is the total misalignment between the light field and the x-ray field. Make an x-ray exposure (for a film/screen speed of 400. Record the exact size of the illuminated boundaries from the collimator alignment tool. Record the initial exposure value (in mR) with nothing in the primary beam (i.) Ensure that the plexiglass covers the AEC detectors. at an SID of 100 cm. Set the unit to operate at 80 kVp (or some other setting commonly used to image a medium-sized patient). L2.. This test is to be conducted on each available radiographic image receptor holder (e. Measure the length and width of the exposed area on the exposed film. (It is acceptable to use another patient simulating material for AEC tests. Field size indicators versus actual exposed area. Then make an AEC-controlled exposure. 2 cm at an SID of 100 cm. and process the x-ray film. All Rights Reserved. the HVL should be a minimum of 2.. Load a cassette of a size commonly used with the standard film used at the facility. Turn on the collimator light and collimate to an area of 20 cm × 20 cm. and W2 on 2. The HVL is most accurately read by plotting the measurements on semilog graphing paper.

Use the most common size of films in the same cassette holder for all checks in this test. 60.1 3. Other controls should be in their normal pre-use positions. Before returning to use Ensure that all controls are set properly.10 AEC kVp Compensation (for units provided with an AEC system). The optical density of the films at all kVp settings checked should agree to within ±0. at intervals recommended by the manufacturer or as indicated by inspection results.2-1. repeat the test using identical setup conditions but with varying amounts of plexiglass in the beam. Lubricate per the manufacturer’s instructions. Recharge battery-powered devices or equip them with fresh batteries.2 3.4 4. At a minimum. For each exposure. Set alarms loud enough to alert personnel in the area in which the device will be used. Place 20 cm of plexiglass (or some other patient simulating material) on the table or support it up against the wall Bucky. All Rights Reserved. . At a minimum. if needed. and wall Bucky). 2. The optical density of all the processed films should agree to within ±0. Replace components if needed. All films used in this test should come from the same batch. table Bucky. If the optical density falls within the range chosen by the radiologists (typically 1. 100 kVp). Calibrate the system to ensure performance within the manufacturer’s specifications. 3. 3. Read the optical density of the radiograph using a densitometer. Adjust all brakes and locks to ensure proper performance. 6 Inspection and Preventive Maintenance System ©1995 ECRI. Ensure that the AEC detectors are covered by the plexiglass.3 OD.3 OD of the optical density at 20 cm. Acceptance Tests Acceptance testing is typically performed by a medical physicist.3 Clean the exterior and interior.g. Preventive maintenance 3. This test should also be conducted on each available radiographic image receptor holder (spot-film. Make a series of AEC-controlled exposures of the 20 cm of plexiglass at different kVp values. Attach a Caution tag in a prominent position so that the user will be aware that control settings may have been changed. process the film on an optimally performing processor. check the optical density at 15 cm and 25 cm of plexiglass. and only one cassette is to be used for all exposures. 80.. Take precautions when dealing with body fluids.Inspection and Preventive Maintenance System Use a densitometer to measure the optical density of the radiograph in the center of the image.4 OD). use three kVp settings (e.

General-purpose Nd:YAG surgical lasers have a laser cavity that houses an yttrium-aluminum-garnet (YAG) crystalline rod that is doped with neodymium 046828 447-0595 A NONPROFIT AGENCY 5200 Butler Pike.064 nm (frequency-doubled units are covered in Procedure/Checklist 464). continuous-wave YAG lasers. bronchopulmonary lasers. catheterization laboratories. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. photocoagulator lasers Commonly Used In: Operating rooms.064 nm. Failure of an Nd:YAG surgical laser can cause patient or staff injury. emit near-infrared energy at 1. These la- sers must be meticulously maintained to ensure proper and safe operation. Nd:YAG surgical lasers are frequently used to cause photocoagulation or thermal denaturation of tissue in the noncontact mode or with quartz or sapphire contact tips. ENT. frequencydoubled and do not emit energy for delivery to the patient at 1. abrupt interruption of a surgical procedure. endoscopy laboratories. KTP or CO2). The extent and frequency of inspection by hospital personnel should be coordinated with these outside services. Plymouth Meeting.Procedure/Checklist 447-0595 Nd:YAG Surgical Lasers Used For: Lasers.g. The 1. and/or vaporization of tissue. also does not apply to CO2 lasers. Nd:YAG [16-943] Also Called: YAG lasers (incorrectly). angioplasty lasers.org . thermal denaturation.064 nm Nd:YAG energy is not well absorbed by any tissue and is typically scattered over a 5 mm depth within tissue. applies to low. PA 19462-1298. surgical lasers. Manufacturers or outside service vendors often maintain lasers for hospitals. This minimizes the need for frequent additional periodic testing. cardiovascular surgery. neurosurgical lasers. cystology rooms.. however.g. short procedure areas. radiology areas Scope: Applies to general-purpose Nd:YAG surgical lasers that include contact (e. High. or damage to the laser system. many of the tests listed herein can be used or modified for these other lasers Risk Level: ECRI Recommended. urology lasers. and can provide sufficient power output to coagulate and vaporize tissue. for example. Nd:YAG surgical lasers affect tissue by delivering invisible near-infrared energy at a sufficient power density to cause photocoagulation. Hospital Assessment. applies to the Nd:YAG portion of units that combine the Nd:YAG wavelength with other wavelengths (e. . gynecology. Surgical. urology. bronchopulmonary.. hours hours Overview Nd:YAG lasers are normally checked before each use by the laser’s power-on self-test and by user examination of the aiming beam and calibration of the system with the delivery system to be used. neurosurgery. sapphire tip) and/or noncontact flexible fiberoptic delivery systems (either reusable or disposable). Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . argon lasers. or other ophthalmic lasers. gastroenterology lasers.and high-power Nd:YAG surgical lasers that are typically used for general surgery. does not apply to ophthalmic Nd:YAG lasers or to Nd:YAG lasers that are. and plastic surgery procedures. gastroenterology.

As a result. and far greater care is required than with most devices. Some Nd:YAG lasers use internal water/air cooling systems. All Rights Reserved. In a well-aligned system. or firebrick Laser radiometer (power meter) Laser safety signs Laser safety eyewear specifically designed for use with Nd:YAG surgical lasers and of sufficient optical density to protect the wearer’s eyes from laser injury Vise with padded jaws or ring stand with padded clamp Pressure gauges and coolant system tee fitting Outlet test fixture (optional) Insulating gloves. The fiber may be used with additional connectors (e. In a few cases (e. about 3″ to 4″ long.. As a result.Inspection and Preventive Maintenance System (Nd). These attachments can focus the energy into a small spot size at a known working distance or a specific beam pattern to accomplish a specific task. 1984 Jun. Fatal gas embolism associated with intrauterine laser surgery [Hazard]. travels the same path) with the Nd:YAG laser beam. with contact tips or contact-tip fibers connected. Lasers: Model policy and procedures statement: Appendix B. which then causes the clinical effect. With Nd:YAG lasers. Any beam pattern distortion at the fiber entrance would be eliminated as the laser beams travel through the fiber because of internal reflections within the fiber. 1984 Jun. these two beams are coincident as they exit the fiber. in this case. 13:167-9. 20:239-316. 1989 Sep.. Misalignment of the beam at the fiber entrance would result in decreased power output or loss or distortion of the aiming beam. or a xenon lamp with filters to emit white or blue light simultaneously traverses the fiber and is coincident (i. articulating arms on CO2 lasers).. ≥1″ wide.e. some lasers may include a gas recirculation system that inserts gas to cool the fiber and/or insufflate the cavity and withdraw gas to limit pressure and avoid distension. excess heat is generated in the laser tube. Test apparatus and supplies Leakage current meter or electrical safety analyzer Ground resistance ohmmeter New. while others require external connection to a water source and drain or to a freestanding cooling system. during gastroscopy). unused fiber delivery system Black Delrin block ≥1⁄2″ thick. Since the therapeutic and aiming laser beams are transmitted through a single optical fiber. Citations from Health Devices Lasers in medicine: An introduction. 13:169-71.g. unlike those lasers that use mirror delivery systems (e. Because Nd:YAG laser fibers may be used in body cavities (e. 1987 Mar-Apr. Lasers as investigational devices: Appendix A.g..g. a second. 1991 Jul-Aug. 16:115. 18:325-6.g.g. Energy leaving the laser tube through a partially reflecting mirror is typically directed into a flexible optical fiber that transmits the laser energy to the tissue. 1984 Jun. any significant problem with the therapeutic beam pattern introduced by an accessory would be apparent by examining the visible aiming beam. no or very little direct laser irradiation of tissue occurs. the Trimedyne Laserprobes SLT contact tips). high voltage (optional) Grounding strap (optional) Calibrated flowmeter Special precautions Inspecting and maintaining lasers is a dangerous as well as necessary process. through an endoscope).. Most Nd:YAG laser fibers require gas or liquid cooling as well for certain applications.. Loss of metal nozzle on Nd:YAG surgical laser fibers [User Experience NetworkTM]. Personnel who inspect or service lasers should receive special training from the manufacturer or from a qualified alternative training source. tongue depressors. gas compressors/regulators and/or fluid pumps are typically integral or attached to these lasers. Like most lasers. and/or with a laser handpiece or a laser micromanipulator (used to interface the laser with the surgical microscope) connected. Surgical lasers [Evaluation]. 13:151-78. . TEM00) within the beam or spot. it is not necessary to periodically verify coincidence of the aiming and therapeutic beam or to assess the therapeutic beam pattern (e. nontherapeutic aiming helium-neon (He-Ne) laser — which emits visible red light — a red diode laser. particularly when the internal interlock is overridden or in any other situation in which the energy does not diverge 2 Inspection and Preventive Maintenance System ©1995 ECRI. requiring a cooling system. Nd:YAG lasers are inefficient in converting electrical energy into laser energy of 0 to 140 W. Because the near-infrared energy emitted by the Nd:YAG laser is invisible. Laser energy can cause serious injury. the laser energy is transformed into thermal energy to heat a catheter tip.

use a firebrick or other nonflammable material behind the target material (e.g. Procedure Before beginning the inspection. exercise great care whenever a laser beam is accessible. Verify that the key has not been left in the laser. 20 kV). and do not aim the laser across a path that a person might normally use as a thoroughfare.. and precautions needed to ensure safety and avoid equipment damage. Do not switch it to the Operating mode until the procedure is about to begin and the laser and its delivery system are properly positioned. the significance of each control and indicator. above 20 kV). sitting. and ensure that they have been turned off after the last use.. which can be lethal. WARNING: Laser safety eyewear may not protect the wearer from the aiming system light. A CO2 fire extinguisher should be readily available. starch. preferably. be sure that you understand how to operate the equipment. post doors to the room with appropriate laser safety signs stating that the laser is in use and that it is unsafe to enter the room without authorization by the service person performing the procedure. In addition. Report any laser accident immediately to the laser safety officer or equivalent.1) before any other item that requires operation of the laser. Do not use the laser in the presence of flammable anesthetics or other volatile substances or materials (e. and avoid contact with any portion of the high-voltage circuit until you are certain that the charge has been drained. and remove the laser operation key and store it in a controlled location. even a full room length or more away from the laser (and can harm tissue or burn material even at this distance). or standing). perform tests with the unit turned off. Examine the exterior of the unit for cleanliness and general physical condition.. Remove from the working area or cover with flame-resistant opaque material all reflective surfaces likely to be contacted by the laser beam. When possible. when kneeling. WARNING: Do not use an anesthesia or other similar bag that may have a mold-release agent (e. The laser should remain in the Off position when not in use. because of the serious risk of explosion and fire. drain. In such instances.Nd:YAG Surgical Lasers significantly over long distances. All Rights Reserved. Under some circumstances.) Examine any external gas tanks that may be in use with the laser. use a redundant ground strap if you must enter the laser cabinet. alcohol). carefully read this procedure and the manufacturer’s instruction and service manual. the laser should be in the Standby/Disabled mode.g. Wear appropriate laser safety eyewear at all times whenever the laser is in the Operating mode. disconnect the laser from line voltage before entering the laser cabinet. Where possible.1 Chassis/Housing. When in use.. even when wearing laser safety eyewear. and use insulated gloves for those procedures in which contact with a high-voltage source is possible (and the gloves are not otherwise contraindicated). Do not stare directly into the aiming system beam or the therapeutic laser beam. or in an oxygen-enriched atmosphere. Qualitative tests 1. If the procedure must be interrupted.g. disconnect the laser from line voltage. Furthermore. Whenever possible. and inform users of the importance of storing the key in a controlled location. A second person should be present. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. a good ground must be present. perform the Grounding Resistance test (Item 2.. 3 . Ensure that equipment intended to be used to measure. (Remove it if it has. Because of the presence of high voltage. especially during procedures of recognized risk. at minimum. or insulate high voltages carries the appropriate insulation rating (e. Be sure that all housings are intact Inspection and Preventive Maintenance System ©1995 ECRI. Consult the manufacturer’s recommended procedures for servicing high-voltage laser circuits. to summon help in case of an accident. talc) on its inside surface because the agent could contaminate the gas recirculation system of the laser and ultimately contaminate a patient wound during a subsequent procedure. use short durations when practical.g. Area security and use of personnel protective devices and practices should be consistent with hospitalwide laser safety procedures and/or be approved by the laser safety committee. Target materials will ignite when exposed to high laser energies. General.g. Capacitors may store charges long after the device has been disconnected from line voltage. Some surgical lasers use high voltages (e.e. Therefore.. 1. Avoid placing the laser beam path at eye level (i. Do not perform these procedures when a patient is present or clinical staff is working. black Delrin) when the laser is to be activated. as well as to the hospital risk manager. the beam may not diverge significantly. windows should be covered with nonreflective material to prevent transmission of laser energy to other areas.

drain. and indicate this in the preventive maintenance section of the inspection form. gas.9 Cables. fiber). Circuit Breakers/Fuses. Check that they are of the correct type. gas). If a cord is damaged. Some Nd:YAG surgical lasers require deionized water. and that there are no obvious signs of water or oil leakage. or.6 1. 1. Check the operation of brakes and swivel locks. Be sure that they grip the cord securely. and that they are secured adequately to any connectors. and electrical fittings and connectors for general physical condition. Examine all controls and switches for physical condition. check its value and type against what is marked on the chassis or noted in the instruction or service manual. AC Plug/Receptacle. liquid. If external gas tanks or wall-supply outlets can be used. and most require special filtration. replace if the pressure drop is >5 psi). Line Cords. and being used. that any retractable parts slide easily and lock in place if so constructed.g. Examine cables carefully to detect breaks in insulation and to ensure that they are gripped securely in the connectors at each end to prevent strain on the cable. 1. Ensure that any mechanism to close off the fiber laser aperture (fiber port) is clean.g.Inspection and Preventive Maintenance System and properly aligned. replace the entire cord. check 1. ensure that they operate smoothly and correctly. Casters/Brakes. 1.g.8 4 Inspection and Preventive Maintenance System ©1995 ECRI..10 Fittings/Connectors. 1. Be sure that no pins are missing from yokes and that the keying and indexing of connectors for each gas to be used is correct. external power meters. and correct motion.12 Filters. open the plug and inspect it. Examine the strain reliefs at both ends of the line cord..g. Clean or replace filters according to the manufacturer’s recommendations (e. If any position appears unusual. If the device has a switch-type circuit breaker. consider the possibility of inappropriate use or of incipient device failure. Measuring the pressure drop across a liquid filter can be helpful in determining whether the filter should be replaced. in good working order.5 1.. There should be no visible dirt or residue in the optical path of the laser aperture. Be sure that mounts or holders intended to secure the fiber to the fiber support (to protect the fiber when in use) are present. clean. Check the condition of all cooling-system hoses and any other hoses or tubing the laser may have (e. Check that the casters roll and swivel freely. A laser that connects to a central piped medical gas system or to a freestanding medical gas system should have the matching DISS or quick-connect fitting for the gas that it is to be used with. check that it moves freely. and listen for rattles that could indicate loose screws. Ensure that a spare is provided or readily available. and is in use. If a control has fixed-limit stops. Be sure to wire a new power cord or plug with the correct polarity. Examine the AC power plug for damage. that they are connected correctly and positioned so that they will not leak. check and record their positions.4 1. Be sure to leave the shutter in the proper position for normal operation. trail on the floor. Electrical contacts should be straight. Clean or replace air filters and radiators that are obviously dirty.3 1. Inspect line cords for signs of damage. Similarly. If the device is protected by an external fuse(s). that assembly hardware is present and tight. kink. Strain Reliefs. If manual shutters for the aiming system or therapeutic laser are accessible. secure mounting.7 1. Inspect all cables and their channels or strain reliefs for general physical condition. . Before moving any controls. that there are no signs of spilled liquids or other evidence of abuse. gas-specific connectors should be present. Gas and liquid fittings should be tight and not leak. that they have not become cracked and do not show other signs of significant abuse. Check that the mounts securely contain any gas cylinders that may be in use. and bright. 1.13 Controls/Switches. Tubes/Hoses. check mounts or holders for other devices (e. footswitches). Check the condition of all liquid and air filters. Shutters. cut out the defective portion.2 Mounts/Holders. Shake the plug. operates smoothly. if the damage is very near one end. If you suspect damage. or be caught in moving parts. Verify that suitable connectors are supplied so that adapters are not required.. General. Wiggle the blades to determine whether they are secure. E xam ine all optical (e. All Rights Reserved.

and. check to be sure that the laser activates and deactivates consistently when the footswitch is depressed and that the fiber-coolant system operates properly when the fiber-coolant switch is activated and deactivated. ensure that each display provides the information expected. Check membrane switches for tape residue and for membrane damage (e.18 Indicators/Displays. 1. as well as positive stopping. and that there are no signs of spilled liquids or other serious abuse. 1. 1.17 Battery. During the inspection. ensure that the cable and any connectors are in good condition. check for proper alignment.. verify the operation of both. Clean any obvious dust from these components. ensure that the water pressure is properly regulated and at the appropriate pressure and that the supply and drain system is properly configured (e.19 Laser Delivery System Calibration. Nd:YAG surgical lasers typically include a user-accessible calibration port leading to an internal power meter that allows output calibration and testing of the laser fiber. including evidence of spilled liquids. This feature is provided because transmis- Inspection and Preventive Maintenance System ©1995 ECRI. pulse or accumulated energy counter). During the inspection. Store some sample information. filters are oriented for proper flow. Some footswitches also include a switch to operate the liquid. notify users to avoid using tape and sharp instruments. such as those used to provide additional power for 110 VAC Nd:YAG lasers. Some footswitches include two internal switches. Ensure that the connector secures acceptably to the laser cabinet. Check all fluid (e. During the course of the inspection. Footswitch.g. If the remote control is attached by cable to the laser.g. and note this in the preventive maintenance section of the inspection form.. Ensure that user prompts occur in the proper sequence. 5 . It is usually possible to feel the vibration caused by closure of the switch. correct motion. If a remote control or display is battery powered. Check the physical condition and proper operation of these components. Be sure that housings are intact. If you find such evidence. If primary and remote-control indicators and displays can be used at the same time or if control can be switched from one to the other during a procedure.g.g. label it with the date. Examine the male and female connectors for attaching the footswitch to the laser cabinet to be sure that no pins are bent and that no other damage is present. Remote. using an ohmmeter..16 Fluid Levels. indicators. If a feature to manually reset this information is available. be sure that each control and switch works properly. Examine the footswitch for general physical condition.Nd:YAG Surgical Lasers for proper alignment. Other batteries. check or replace the battery (periodic prophylactic battery replacement is often preferred to risking battery failure during use). ensure that it works. All Rights Reserved.. if present. pens. Where a control should operate against fixed-limit stops. even through a shoe. that assembly hardware is present and tight. settings. Check to be sure that this switch operates reliably. If lubrication is required. as well as positive stopping.g. If an external water supply is in use. in this case. drain hoses are positioned in a sink or drain). Flex the cable at the entry to the switch. surgical instruments). Check that the internal switch is operating and that the footswitch does not stick in the On position.. Examine all controls and switches for general physical condition. check for internal wire breaks that cause intermittent operation. should be inspected according to the manufacturer’s recommendations. Footswitches for lasers include an internal switch that activates according to the depth of pedal depression. During the procedure.or gas-cooling system. If display screens or digital displays are provided for user prompts or for viewing accumulated information (e. and verify that it is correct. coolant) levels. displays) is indicated on both controls. gauges. from fingernails.15 Motors/Pumps/Fans/Compressors. operate the laser in a way that will verify that the same information (e. meters. Note any error messages displayed during the power-on self-test. and visual displays on the unit and remote control. Examine the exterior of the control for cleanliness and general physical condition. verify proper operation of all lights. When it is necessary to replace a battery. be sure to check that each control and switch performs properly. secure mounting. 1. 1. and intended range of settings. Ensure that all segments of a digital display function. note this in the preventive maintenance section of the inspection form. Confirm that strain reliefs are secure. Refill or change the fluid according to the manufacturer’s recommendations.

3) are present and legible. as well as the fiber support. setting change). (For some lasers. lenses) for cleanliness and general physical condition. General. test this feature to be sure that it deactivates the laser and that the laser will subsequently restart. for cleanliness and general physical condition. Verify that all necessary accessories are available and in good physical condition. If a tip appears to be dirty or damaged. making the laser potentially unavailable. All Rights Reserved. if necessary. tips.) After deactivating the laser and reclosing the door or window. Check for proper operation. labels. 1.. (Do not remove other parts that are press-fit or attached by screws. Examine each handpiece component (e. Be sure to check with the person responsible for scheduling the use of the laser before beginning the procedure. fiber. Checking all fibers or accessories during a single inspection and preventive maintenance procedure is unnecessary as long as accessories are routinely checked by the person(s) responsible for laser setup and operation. notify the person(s) responsible for fiber repair. many of the accessories are sterile and would require resterilization before use.Inspection and Preventive Maintenance System sion of laser energy through a fiber can change in response to fiber use. .. Examine each tip that may be used with the laser fibers for cleanliness and general physical condition. the function of the interlocks can be checked using an ohmmeter..g. (Do not disassemble major parts of the laser to test internal interlocks. Be sure that all hardware (e. or it may require the user to do this manually. Examine the distal end of fibers to ensure that any connecting mechanisms (e. bolts. Ensure that the aperture connector properly seats into the laser aperture of the laser cabinet. body.23 Accessories. In addition. laser gas tubing channels) is present. handpiece) that the manufacturer indicates can be acceptably calibrated using these procedures. 1. laser emission. The fiber should be repaired and/or cleaned according to the manufacturer’s recommendations. Check that all placards. if present. in good condition. examine the aperture connector.g. and verify that all visual and audible alarms activate according to the manufacturer’s documentation. threads) are in proper working order. Be sure that the mechanism to connect a tip to a fiber is in proper working order and forms a secure connection. if you are unsure about the need to clean or repair a tip.22 Labeling. Examine individually only those components that are intended for removal during normal use and storage.) If the laser is equipped with an emergency “kill” switch. operate the laser in a manner that will activate each audible and visual alarm.g. Verify that this feature is functioning by using the manufacturer’s recommended calibration procedure to test one delivery system (e.. Check to see that an instruction manual is kept with the laser or is readily available. and instruction cards noted during acceptance testing (see Item 4.21 Audible Signals.g.20 Alarms/Interlocks. Operate the device to activate any audible signals (e. Operate the device in a manner that will activate the self-check feature. For the test fiber and before each use. Some tips may look dirty after a single use. If a door or window interlock is used. Fibers. Based on the measurement from the calibration power meter. If no self-check feature is present. and firmly attached. If a fiber appears to be dirty or damaged. Handpieces. the laser may automatically recalibrate itself and/or adjust displays so that the power indicated to be delivered to the patient will be correct.) If 6 Inspection and Preventive Maintenance System ©1995 ECRI. cable. Set up reusable accessories with the laser to ensure compatibility and proper functioning. but remain acceptable for use.g. Verify fiber performance. (Contact tips cannot be calibrated using the laser’s calibration power meter. be sure to test only those alarms that will not cause damage to the laser or present an unnecessary risk of laser beam exposure to yourself or bystanders. 1. Be sure to check the interlocks in all locations where the laser is used. or snap-rings. consult with the person(s) responsible for tip repair or replacement and with the manufacturer. check to be sure that the laser will restart. Contact tips. ensure that it properly deactivates the laser. and verify that the signal can be heard in the environment in which the laser will be used.) 1. remove it from service. If a fiber is reusable. remove it from service and notify the person(s) responsible for tip repair or replacement.. and tip of each fiber to be used.

WARNING: Make this inspection with the laser powered off. Consult the manufacturer’s recommendations for the procedures and cleaning agents to use to clean the objective lenses. Connect the micromanipulator to the microscope to check for a secure connection. consider using a calibrated flowmeter to measure actual gas flow. Examine the microscope micromanipulator for cleanliness and general physical condition. and ensure that it fits snugly.) Inspection and Preventive Maintenance System ©1995 ECRI. do not hold it by the joystick. If proper operation is questionable. Consult the manufacturer’s recommendations for the procedures and cleaning agents to use to clean reflecting surfaces and lenses. and do not touch the reflecting lenses in the body. Check that the intensity control. 2. Microscope micromanipulator. There should be no visible dirt or residue in the optical path of the laser aperture. and verify that it produces a round.1 Grounding Resistance. be sure that it turns easily and does not slip. Quantitative tests WARNING: In general. WARNING: Do not use an anesthesia or other similar bag that may have a mold-release agent (e. Do not touch the lens surface. Be sure to handle it by the main body. We recommend a maximum of 0. when assembled. talc) on its inside surface because the agent could contaminate the gas recirculation system of the laser and ultimately contaminate a patient wound during a subsequent procedure. It should be clean and undamaged. handle lenses by the edges only. and footswitch.26 Gas Regulators. Inspect the mechanism used to attach the micromanipulator to the microscope to ensure that all parts are present and that it is in good working order. ensure proper operation by allowing it to control the gas supply into and out of a sealed plastic bag. All Rights Reserved. ground pins.g. 2. 7 . Consult the manufacturer’s recommendations for the procedures and cleaning agents to use to clean lenses.g. Verify operation of safety filters in microscope and endoscope delivery systems. check pulsing controls to verify that the aiming beam can be pulsed. Inspect micromanipulators provided by both the laser manufacturer and the laser accessory manufacturer. Remove and inspect the protective window (e.5 Ω. verify that each color is present and working properly.. If a zoom focus feature is present. or multimeter with good resolution of fractional ohms to measure and record the resistance between the grounding pin on the power cord and exposed (unpainted and not anodized) metal on the chassis. starch. Carefully insert each lens into the micromanipulator. accessory outlet.. does change the brightness of the aiming beam. are secure.Nd:YAG Surgical Lasers lenses are detachable.24 Aiming Beam. Use an ohmmeter. Safety filters. clean or replace if needed. 1. Ensure that the mechanisms used to connect the handpiece(s) to the fiber are in good working order and that they reliably secure each handpiece to the fiber. (If the footswitch is of low voltage. Ensure that major subcomponents of the handpiece. 1. ensure that it is firmly attached and properly oriented. During the procedure. Examine the joystick to ensure that it is firmly attached and that it freely moves the reflecting lens. grounding is not required. If the laser includes a gas recirculation system. blast shield) behind the laser aperture. electrical safety analyzer. Examine any gas regulators for cleanliness and general physical condition. uniformly bright spot. Ensure that the gauges on the regulators are not broken. verify that the spot size changes as expected and still remains uniform. Examine each objective lens to ensure that it is intact and clean. Ensure that the reflecting surfaces and lenses are intact and clean. 1. Similarly. ensure that the regulator and the gauge operate as expected. Be sure that a key or wrench to facilitate changing the gas supply is with the unit or readily available. if present. be sure not to touch the lens surface. If several color choices are available for the aiming beam. For handpieces that provide adjustable spot sizes. Use of this kind of cooling rather than gas fiber cooling may damage test equipment or cause erroneous test results.25 Laser Aperture. do not use liquid fiber cooling for tests unless specifically described in the item. with no halo. Activate the aiming beam (without the therapeutic beam). If a finger rest is present. Verify that the correct gas is attached to each regulator.

1 Clean the exterior. In addition.g.. use the following less preferable alternative. and you must know and meticulously follow them.g. Some laser power meters can measure pulse duration. medium (e. compare the reading obtained with the reading taken on incoming acceptance testing. With the laser set to about 10 W and the exposure set at minimum duration. With the laser set at low (e. Place and secure the laser fiber. The leakage current on the chassis should not exceed 300 µA. activate the laser and create a burn. and release the footswitch after about 1 sec.4 Repeat Pulse.Inspection and Preventive Maintenance System 2.5 Footswitch Exposure Control. 3. Compare the burns to verify that progressively larger burns occurred as the exposure duration increased.. or micromanipulator with the aiming system focused on the target material (e. except continuous. and have developed a series of burns. Set the laser to about 10 W and a 0. black Delrin or a tongue depressor). Some power meters require that the unfocused or a defocused laser beam be projected into the power meter to cover the majority of the absorber surface. mW) feature.g. Preventive maintenance Verify that all daily preventive maintenance procedures recommended by the manufacturer are carried out. and maximum Repeat Pulse settings. nondiverging laser beam. If you are using such a power meter. activate the laser for a sufficient period to acquire acceptable readings.g. With the laser attached to a grounded powerdistribution system. Improper attachment of conductors may damage the laser.10 Power Output. ensure that appropriate grounding is present. Some laser power meters can react quickly enough to be used to test this feature of the laser. and perform the manufacturer’s recommended user calibration procedure. If the laser beam is focused on the receiver of such meters. handpiece.1 sec exposure duration with the fiber. or after the last service procedure. (Power meters use different time constants to acquire an acceptable reading.. handpiece.. Continue this process until you have tested all exposure settings. 2. 2. 50% of full scale). test the laser to be sure that the correct power is repeatedly delivered over the correct time period..3 Exposure Duration. If the unit includes a Repeat Pulse feature. 2. If your laser power meter cannot be used for this test. test it in a similar fashion with a power meter of appropriate resolution in the low-power range. Carefully move the target material to expose a clean area. median. and verify that the Repeat Pulse feature operates as expected by moving the target material slightly between each pulse. if the laser power meter does not measure pulse duration. and activate the laser at each setting. If the power meter can react to pulse duration (this is the preferred circumstance). Where it is greater than 300 µA. at the last preventive maintenance procedure. maintaining the same distance. the measured and displayed values should all be within 10% of one another. Secure the delivery system at the distance from the laser power meter to meet spot-size requirements specified in the instructions for the meter. Because of the heightened risk associated with an unfocused. Set the output time for about 5 sec. 3. in no case should it exceed 500 µA. fiber. use this alternative test method..g. Clean cooling system fibers and accessible optical components (e. or micromanipulator attached. test the laser at each setting. Be extremely careful to keep hands out of the laser beam path. which repeats the pulse at a fixed or adjustable rate. If the laser includes a low-power (e.1 sec or the next longest duration.) Compare the reading with the power display of the laser.g. WARNING: Do not reverse power conductors for this or any other test. the meter may be damaged. If the number or duration between repeat pulses is adjustable. Verify that the beam turns off when the footswitch is released. activate the unit. if adjustable. test this feature with the laser set at the minimum. blast 8 Inspection and Preventive Maintenance System ©1995 ECRI. 10% of full scale). . 2. Adjust the exposure setting in increments of 0. All Rights Reserved. However. Select one delivery system (e. handpiece. micromanipulator).) WARNING: Accessing the unfocused laser beam may require defeating internal interlocks. (Do not focus the beam to a small spot on the power meter. test that setting changes made throughout the range result in the expected performance. measure the leakage current between the chassis and ground with the unit grounded and ungrounded. and maximum output. exercise great care if the interlocks are to be defeated.2 Leakage Current.

Nd:YAG Surgical Lasers shield. Or. Casters/Mounts/Holders.4 Electrical Wiring Configuration. Check all fluid levels and supplement or replace fluids if needed.) Pulse Duration.2 Delivery systems with less than the manufacturer-recommended transmission (typically 80%) should be discarded if they are disposable. pump. 9 . Power Range. Connect the laser to each receptacle and confirm that the laser operates properly. In addition.. but over the full range of available settings. Verify that the plug is acceptable for use with the maximum current and voltage specifications for operating the laser. handpiece) that the manufacturer indicates can be acceptably calibrated using these procedures. do not switch conductor connections or wiring configurations for any tests. Examine the unit and note the presence. and place a Caution tag in a prominent position so that the next user will be careful to verify control settings. Labeling information is typically found in the laser’s operator manual. Laser Delivery System Calibration. and high settings. are functioning properly. fan. Ensure that the branch circuits and the outlets for the laser are properly wired and rated for use with the laser. Calibrate/adjust any components (e.1 Areas of Use. lasers powered by three-phase electrical systems may be damaged if proper electrical phase connections are not made initially and maintained thereafter.3 4.6 4. 4.7 4. Also test the ability of the laser to deliver laser energy as expected in all configurations and with all provided laser accessories. printer) according to manufacturer recommendations.g.3 Inspection and Preventive Maintenance System ©1995 ECRI. proper phase rotation) has been installed. including leakage current measurement. All Rights Reserved. Replace filters if needed. if present. 3. WARNING: Lasers may be damaged by switching between normal and reverse polarity while the device is on. turn off the unit being tested before switching polarity. Ensure that all hoses and tubes are tight. fiber. Before returning to use Be sure to return controls to their starting position.g. if necessary. Visit the area(s) in which the laser is to be used and ensure that laser signs. and function before using the unit. If reverse-polarity leakage current measurements are made. location. medium. proper neutral and ground connections. Acceptance tests Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. 4. 4.) Note the fiber transmission for each delivery system tested if this information is provided by the laser. Using the technique described in Item 2. you can calculate it using the following formula: % Transmission = Delivered power × 100% Power entering the fiber 3.g. a line cord threshold). Do not conduct electrical leakage current tests with reversed-polarity wiring. eyewear.4. Also. as may occur during transport.4 4. Ensure that the assembly is stable and that the unit will not tip over when pushed or when a caster is jammed on an obstacle (e. test the power output accuracy at several low.. specifically confirming that motors are operating in the proper direction.g.9 4. using techniques and cleaning solutions recommended by the manufacturer. (Contact tips cannot be calibrated using the laser’s calibration power meter. Examine the receptacles at each location where the laser is to be used to ensure that the proper electrical configuration (e. compressor. setup. ensure that it has nonslip legs or supports. If the unit includes a Repeat Pulse feature.2 Lubricate any motor. test this feature as described in Item 2.. Only appropriately trained personnel should attempt laser adjustments. Verify that progressive increases in pulse duration throughout its range of adjustment result in progressively larger burns. or repaired if they are reusable and intended for repair. 4. If the device is designed to rest on a shelf. Use the manufacturer’s recommended calibration procedure to test each new reusable delivery system (e. or printer components as recommended by the manufacturer. and content of all labels. and window coverings are available and being used and that safety interlocks for doors or windows.. Labeling. Thus. Repeat Pulse. (Consult National Electrical Manufacturers Association [NEMA] configurations for general-purpose nonlocking and locking connectors if in doubt.8 4.5 3. microscope lenses). AC Plug. perform the following tests.10.

This procedure covers the stand-alone units but can be adapted for other units. Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. hours hours Overview Oxygen-air proportioners are designed to mix compressed air and oxygen to user-selectable oxygen concentrations varying from 21% to 100% at high. proportioners have built-in reed alarms that sound when there are large pressure differentials at the gas inlets or when there are low inlet or outlet pressures. occasionally used in operating rooms and most other patient care areas Scope: Applies to external oxygen-air proportioners. tracheostomy tubes. Oxygen-air proportioners operate by receiving air and oxygen from central gas pipelines in the hospital or from other compressed-gas sources. air and oxygen enter a mixing valve that regulates their proportions as they flow out of the unit. When input pressures drop too low or differ greatly. Plymouth Meeting. At these matched or preset pressures. 022999 444-0595 A NONPROFIT AGENCY 5200 Butler Pike. However. Ideally. The most common problems related to these units involve the contamination of oxygen or air sources due to backflow of the other gas and the delivery of inaccurate oxygen concentrations. . Their mixed-gas output is often passed through a humidifier or a nebulizer and delivered to patients through ventilators.Procedure/Checklist 444-0595 Oxygen-Air Proportioners Used For: Oxygen-Air Proportioners [12-876] Also Called: Oxygen blenders. oxygen hoods. For this reason. oxygen tents.org . the two input gas sources are regulated at equal pressures (usually 50 psi). endotracheal tubes. proportioners have their own pressure-regulating mechanisms to match input supply pressures or adjust them to preset levels at or below inlet supply levels.or low-output flows. can be adapted for proportioners that are built into ventilators Risk Level: ECRI Recommended. or masks at flows ranging from 1 to more than 100 L/min. These problems are most often caused by buildup of moisture or particulates inside the units from the compressed-gas lines. PA 19462-1298. NICUs. Oxygen-mixing devices are built into ventilators or supplied as stand-alone units. oxygen controllers. such as tanks or portable air compressors. oxygen-air mixers Commonly Used In: Critical care units. proportioners cannot deliver accurate concentrations. hospitals can maintain accuracy and reliability by installing water-trap filters at the gas inlets and using gas filtration and drying systems at compressed-gas sources. Hospital Assessment. Along with regular preventive maintenance schedules. because this is often not the case. Medium.

1 Chassis/Housing. 14:263-76. . may be facilitated by these kits.000 psi Nondisposable corrugated breathing hose (disposable tubing may be used only if it provides reliable connections) Oxygen analyzer with at least ±3% accuracy and with a “T” adapter for sensor head Flow-control valve Teflon tape Cleaning solvent recommended by the manufacturer Lubricant specified by the manufacturer Figure 1. Test apparatus and supplies Although this procedure can be performed using only the common tools and materials listed below. 18:366. Qualitative tests 1. cylinder pressures should be at least 1. and that there are no signs of spilled liquids or other serious abuse. High-flow flowmeters with a range of 0 to 100 L/min (accurate to within 10% of reading) Flowmeters with ranges of approximately 0 to 50 mL/min and 1 to 15 L/min with 10% accuracy Hoses and adapters for connecting pressure gauges and flowmeters to equipment being inspected Cylinders of oxygen and air with pressure gauges that can be regulated between 0 and 100 psi. 1985 Nov. Turn off all pressurized gas sources when they are no longer in use. and the alarm capabilities. If it is attached to a wall or rests on a shelf. Examine the exterior of the unit for cleanliness and general physical condition. All Rights Reserved. Also. determine if any special inspection or preventive maintenance procedures are recommended by the manufacturer. consult your service manual to determine if a kit is available.2 2 Inspection and Preventive Maintenance System ©1995 ECRI. 14:401. Be sure that plastic housings are intact. as well as service and repair. check the security of this attachment. carefully read this procedure and the manufacturer’s instruction and service manuals. that all connectors are present and tight. Inaccurate O2 concentrations from oxygen-air proportioners [User Experience NetworkTM]. some manufacturers sell special service kits for their units. See Figure 1 for a typical test setup. the significance of each control and indicator. be sure that you understand how to operate 1. Using a double flowmeter assembly in lieu of an oxygen blender [User Experience NetworkTM]. Mount/Fasteners. 1989 Oct.Inspection and Preventive Maintenance System Citations from Health Devices Oxygen-air proportioners [Evaluation]. Typical test setup the equipment. 1985 Jul. 1. Procedure Before beginning an inspection. If the device is mounted on a stand or cart. Special precautions All testing should be done with pressure gauges and flowmeters specified for oxygen or medical gas use only. examine the condition of the mount. This procedure.

4 of the form.13 Controls/Switches. check the manufacturer alarm specifications. With the output disconnected. measure the flow from its high-flow outlet. including high-pressure hoses. measure the maximum flow rate out of the proportioner. Inspection and Preventive Maintenance System ©1995 ECRI. Preventive maintenance 3. 5 and 30 L/min). If the proportioner has two outlets. Adjust input pressures to the proportioner’s specified alarm conditions. Adjust input pressures to 50 psi. Using a high-flow flowmeter. With the loss of an input source.1 and 3. 1.. Alarms. Check that control knobs have not slipped on their shafts.6 2. If the proportioner has adjustments for anything other than O2 concentration (e. secure mounting.12 Filters.g. measure the maximum flow rate when the concentration is set to 21% and 100%. Lubricate per the manufacturer’s instructions.18 Indicators/Displays. Record the settings of those controls that should be returned to their original positions following the inspection. Repeat this procedure with the other input source. During the course of the inspection.1 3.g. and correct motion. flowmeters. Turn off one of the input supplies and verify that the unit continues to alarm and deliver adequate flows at all concentration settings. make sure that the keying is correct. During the course of the inspection. be sure to check that each control and switch performs its proper function. Some proportioners have lowflow continuous bleeds to the atmosphere to improve accuracy. Unless designed specifically to deliver low flows (e. using an oxygen analyzer.3 Maximum Flow Rate. the proportioner should be able to deliver at least 80 L/min from its high-flow outlet when the concentration is set at 60%. Verify that the alarms can be heard clearly and that the unit delivers accurate concentrations before the alarm sounds. check for proper alignment as well as positive stopping.g. Flow differences greater than 10 L/min indicate a restriction at one of the inlets and probably the need to replace an inlet filter. and 100% with the flowmeters adjusted to deliver flows over the range that would typically be used (e. Check-Valve Leakage. If they appear to be set to unusual values.. confirm the operation of all gauges and visual displays on the unit. 2. 1. check their positions. Also.4 1. and water-trap filters. output pressure).24 Low-Flow Bleeds. DISS gas connectors) are used. 1.5 2. Replace filters if their time of use has exceeded the manufacturer’s recommended interval or if the proportioner’s performance indicates that they need to be changed (see Item 2. 1. 2. The flows at these concentration settings should not differ by more than 10 L/min. Flow with Loss of an Input Source. 60%. They should be tight and should not leak. below 15 L/min).Oxygen-Air Proportioners 1. Note that not all proportioners have the same alarm conditions. High-pressure hoses should be supplied with the appropriate oxygen and air DISS fittings to match their outlet fittings. Check that all necessary placards and labels are present and legible.3). the proportioner should be able to deliver at least 30 L/min from its high-flow output and 15 L/min from its low-flow output. Check the condition of all tubing and hoses.. or dirty and that they do not leak.2 3. Use Teflon tape to ensure sealing when replacing any pipe-thread fittings that were removed for filter replacements. 2. Examine all controls and switches for physical condition.. and indicate this on Lines 3. Calibrate per the manufacturer’s instructions.22 Labeling. measure the concentration from the proportioner output at settings of 21%. Examine the condition of all gas fittings. Quantitative tests 2. 3.3 Clean the exterior and interior. Water-trap filters should be clean and drained of all fluid.8 Tubes/Hoses. consider the possibility of inappropriate clinical use.10 Accuracy. 1. 1. Be sure that they are not cracked.23 Accessories. if needed. Never use lubricants that will react with oxygen. no more than 0. Where a control should operate against fixed-limit stops. alarm limits. Confirm the presence and condition of accessories.1 L/min should leak from the second input source. Apply 5 psi to one input source and attach a flowmeter to the second source. Clean or replace inlet gas filters where appropriate. If keyed connectors (e. Inspect the proportioners to ensure that the bleed outputs are not blocked or clogged by tape or dirt. kinked. Accuracy should be within 3%. All Rights Reserved.g.10 Fittings/Connectors. 3 .

Where appropriate. attach a Caution tag in a prominent position to alert users that alarm or control settings may have been changed. hoses. Before returning to use Depressurize all external gas supplies and make sure that alarms and controls are set to appropriate levels. dirty filters. 4 Inspection and Preventive Maintenance System ©1995 ECRI.Inspection and Preventive Maintenance System 3.4 Replace tubing. . Acceptance tests Conduct major inspection tests for this procedure. All Rights Reserved. and damaged components if needed. 4.

In the past. The reliability of oxygen sensors can also be affected by other factors. Continuous monitoring of oxygen concentration may also be required in applications of critical care ventilators or other oxygen administration equipment. Use of a properly functioning oxygen analyzer in conjunction with the anesthesiologist’s educated hand (on the reservoir bag) and ear (listening to breath sounds) greatly increases the likelihood that an adequately oxygenated mixture will be directed into the patient’s lungs. ECRI has recommended that all anesthesia patient circuits incorporate oxygen concentration analyzers/monitors (hereafter referred to simply as oxygen analyzers) with alarms. some analyzers 010106 417-0595 A NONPROFIT AGENCY 5200 Butler Pike. Most oxygen analyzers for breathing circuits operate on electrochemical principles and use polarographic electrodes or galvanic cells. We consider this essential to protect patients from hypoxia. USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri. Oxygen analyzers can accurately measure oxygen concentrations.g.g. oxygen hood). endotracheal tube) or in the oxygen delivery device (e. Nitrous oxide can be reduced by a polarographic electrode. High. which may be measured at or near the airway (e. but at a higher voltage than that required by oxygen. as demonstrated in our evaluations of the devices. Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . hours hours Overview For several years.org . The devices are too often found with their batteries or sensors depleted. since the analyzer senses the oxygen concentration in the inspiratory line of the patient circuit rather than at the oxygen flowmeter or common gas outlet of the anesthesia unit where oxygen concentration may be higher than in the patient circuit... Hospital Assessment. Daily checks by the user are essential to ensure accuracy and response. Some paramagnetic oxygen analyzers are also used. Plymouth Meeting. PA 19462-1298. An oxygen analyzer should also be used regularly to check the accuracy of ventilator settings. For example. also applies to devices used to calibrate or verify the oxygen concentration in certain medical gases. However. and to devices used to calibrate and verify performance of oxygen-mixing devices (see Oxygen-Air Proportioners Procedure/Checklist 444) Risk Level: ECRI Recommended. it is often essential to collect and store data on the concentration of inspired oxygen and the total time duration at each level. when ventilating some infants.Procedure/Checklist 417-0595 Oxygen Analyzers Used For: Oxygen Analyzers [12-858] Oxygen Monitors [12-863] Also Called: Oxygen monitors Commonly Used In: Operating rooms and critical care unit