| MODEL IV-100B INFANT VENTILATOR | |] OPERATIONAL INSTRUCTIONS AND ROUTINE MAINTENANCETL SELHRIST SSS IDUSTRIS, IC E NE: We, Sechrist Industries, Inc. Sechrist Industies Gabi 4225 East La Palma Avenue Frauholz-stasse SB Anaheim, Califomia 92807 CH-6422 Steinen U.S.A Switzerland (714) 579-8400 41-41-832-23-28 declare under sole responsibility that the Model IV-100B Infant Ventilator © Model 3200/3200R Hyzerbaric Chamber Model [V-100B SAVI System Model 2500E/2500ER Hypertaric Chamber Model [V-200 Infant Ventilator Model 3200E/3200ER Hyperbaric Chamber Model [V-200 SAVI System . to which this declaration relates, meets the essential health and safety requirements and is in conformity with the Council Directive No 89/336/EEC of 3 May 1989, as amended by Council Directive No 92/31/EEC and Couneil Dizectiv2 No 93/68/EEC, relating to electromagnetic compatibility and the following Larmnized standard and other nonnative documents: EN 60601- 2 "IEC 601-1-2: 1993 The conformity of these products was evaluated and confirmed by TUV Product Serv GmbH. The following CE conformity marking has been affixed on the devi the directive requirements. Greg GodSey, Vice President Quality Assurance/Regulatory Airs Sechrist Industries, Inc., Anaheim September 1997 4225 r. La Palma Avenue + Telephone 714/578-8400 + Tax 714/576.WARRANTY SECHRIST INDUSTRIES, INC. warrants this product to meet the published specifications and to be free from detects in material and workmanship under normal use for a period of one (1) year from the date of purchase. THE FOREGOING IS IN LIEU OF ANY OTHER WAR- RANTY, EXPRESS, IMPLIED OR STATUTORY, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY. The sole liability of SECHRIST under this warranty is limited to replacing, repairing, or issuing credit at the discretion of SECHRIST for the products, equipment or parts which fail to meet the published specifications or which be- come defective during the warranty period and which are upon examination by SECHRIST found not to meet the published specifications or to be defective in material or workman- ship. SECHRIST will not be liable under this warranty unless the following provisions are strictly complied with: (a) SECHRIST is promptly notified, in writing, upon discovery of the failure of said product or equipment to meet the published specifications or of defects in ma- terial or workmanship, (b) the defective product, equipment or part thereof is returned to SE- CHRIST, transportation charges prepaid by the buyer, (c) the defective part is received by SECHRIST for examination no later than one (1) month following the expiration of the war- ranty period and provided (d) that examination by SECHAIST of said product, equipment or part shall disclose to SECHAIST'S satisfaction that such detect has not been caused by improper usage, accident, neglect, alteration, abuse, improper installation or unauthorized repair. Products, equipment or parts replaced under this warranty are warranted only through the terms of the original warranty, SECHRIST neither assumes nor authorizes any other person or entity to assume for it any other warranty, obligation or liability in connec- tion with Its products or equipment whatsoever, and this warranty can ofly be changed in writing by a duly authorized representative of SECHRIST. SECHRIST makes no represen- tations or warranties whatsoever as to the fitness or usefulness of the products or equip- ment manufactured by it for any medical treatment, physical condition or other purpose whatsoever. In no event shall SECHRIST be liable for personal injury, property damage or any special or consequential damage to any buyer, user or any other person whomsoever, including, but not limited to, loss of profits, loss of use of the product or equipment, or for damages of any other kind whatsoever based on a claim for breach of warranty other than a refund of the purchase price of any defective product or equipment. Any authorization for repair or alteration by buyer must be in writing from SECHRIST to prevent the voiding of this warranty. In the event SECHRIST or its representatives render any technical acvice or service of any kind to buyer or anyone else in connaction with the equipment or products covered by this warranty, the buyer hereby releases SECHRIST from all liability of any kind whatsoever as a result thereof; and the warranty as hereinbefore set forth shall not be enlarged or affected by said action by SECHRIST.Th HK * sarery avert * HK KKK KK SECHRIST/HEALTHDYNE (INFRASONICS) INCOMPATIBILITY It has come to our attention at Sechrist Industries, that the diaphragm retaining cap of the Healthdyne (infrasonics) Model 190 reusable exhalation valve is similar in appearance to the retaining cap (P/N IV- 305-02) provided with the Sechrist Model IvV-305 and IV-335 neonatal exhalation valve. In fact, the Healthdyne (Infrasonics) component can be interchanged with the end cap provided wi he Sechrist exhalation valve. When the Sechrist exhalation valve is assembled with the Healthdyne (Infrasonics) component, the inspiratory pressure control of the Sechrist Infant Ventilator (Models IV-100, IV-100B and/or IV-200) may be adversely affected. Our engineers have discovered that at certain ventilator control settings, patient cuit pressure will build uncontrollably (to the static safety pressure relief valve setting) when the Healthdyne (Infrasonics) component is used in the Sechrist exhalation valve. Sechrist Industries feels that such interchangability is potentially lethal to the neonatal patient. Please take a few moments to note the following principle differences between the Sechrist and Healthdyne (Infrasonics) components. 5 GE 1 HOLE SECHRIST HEALTHDYNE (INFRASONICS) End view, Inside - Two holes are drilled into the Sechrist cap; a single hole is drilled into the Healthdyne (Infrasonics) cap. Side View - The Sechrist cap exhibits: a narrow O-ring retaining groov and a wider groove towards the inside end. The Heal! infrasonics) cap only exhibits a narrow O-ring retaining groove raised tab on the outside end of the Sechrist cap is machined £1 raised tab of the Healthdyne (Infrasonics) cap has a curved st Please contact Technical Assistance, if you have any questions garding this. incompatibility.SECHRIST MODEL IV-100B INFANT VENTILATOR OPERATIONAL INSTRUCTION MANUAL OWNER/USER RESPONSIBILITY SECTION a. INTRODUCTION A. SUMMARY OF WARNINGS AND CAUTIONS OPERATING INSTRUCTIONS A. mooag GENERAL DESCRIPTION DESCRIPTION OF CONTROLS PATIENT CIRCUIT SET-UP AND OPERATION ACCESSORY APPLICATIONS 1. PEDIATRIC EXHALATION VALVE 2. ANESTHESIA EXHALATION VALVE 3. 12 V.D.C. OPERATION VARIATION OF THE AIRWAY PRESSURE WAVEFORM SPECIFICATIONS PERFORMANCE VERIFICATION PROCEDURE SERVICE POLICY ROUTINE MAINTENANCE D. CLEANING & STERILIZATION TROUBLESHOOTING ROUTINE MAINTENANCE PROCEDURES REPLACEMENT PARTS LIST UNDERSTANDING GUIDE A. B. P/N 100088 Rev 4 UNDERSTANDING THE Iv-100 UNDERSTANDING THE SECHRIST AIR OXYGEN MIXER 08/24/94 i 19 26 31 34 36 38 39 42 a7 48 49 51 56 64 7 18 25 30 34 36 4. 46 50 63 76 82OWNER/USER RESPONSIBILITY Caution: Federal law restricts this device to sale by or on the erder of a physician. The Sechrist Model IV-100B Infant ventilator is a sophisticated instrument designed for use by qualified personnel under the direction of a qualified Physician. Before attempting to use this device in an actual life support situation, the operating personnel must become thoroughly familiar with the instructions in this manual. The Sechrist Model IV-100B Infant Ventilator will perform in conformance with the specifications and description contained in this instruction manual and other accompanying labeling when assembled, operated, maintained and repaired in accordance with the instructions contained in this manual. The ventilator must be checked periodically as specified in this manual. (See the Performance Verification Procedure.) A defective ventilator should not be used. Should repair be necessary, Sechrist Industries, Medical Products Division, recommends that a request for service be communicated to the Authorized Sechrist Distributor which originally effected delivery of the device. If a suitable response is not received within a reasonable time, communicate directly with our home office in Anaheim, California. This product should not be repaired other than in accordance with written instructions from Sechrist, or modified in any way without written approval from Sechrist. The user of this product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than Sechrist Industries. TO PROPERLY IMPLEMENT THIS WARRANTY, THE END-USER MUST COMPLETE AND RETURN THE WARRANTY ENACTMENT FORM TO SECHRIST INDUSTRIES. A COMPLETED WARRANTY ENACTMENT FORM MUST BE ON FILE WITH SECHRIST INDUSTRIES BEFORE WARRANTY SERVICE CLAIMS WILL BE HONORED.WARNING It should be noted that whenever a patient is attached to a ventilator, constant attendance is required by qualified personnel. The use of a ventilator with built-in alarm systems or additional alam systems does not give absolute assurance of warning for every type of malfunction that may occur with the ventilator/patient system. In addition, some problems may require immediate attention. WARNING only use replacement parts provided or approved by Sechrist Industries, Inc.e INTRODUCTION You may be very anxious to put your new Sechrist Model IV-100B Infant Ventilator to use, but before you do, we ask you to thoroughly read through these instructions. Please follow all instructions to be sure that the unit has arrived safely and will perform its intended design functions. These instructions are intended to make operational personnel fully aware of the function and effect of the various controls, performance verification procedures and maintenance requirements of our device. First, determine that all the pieces have arrived. Compare the contents of the packages received with the shipping bill of materials. Second, determine that all the pieces have arrived without physical damage. Visually inspect everything. Should any damage be found, it must be reported to the shipping carrier as soon as possible, otherwise it becomes difficult to make a claim. Finally, please take a moment to complete and return the Warranty Enactment Form in this manual or a facsimile thereof to effect the product warranty. A completed Warranty Enactment Form (signed and dated) must be in the possession of cur home office before any claims for warranty parts or service will be honored. Please return the completed Warranty Enactment Form to: SECHRIST INDUSTRIES, INC. 4225 E. La Palma ave. Anaheim, CA 92807 PHONE: (714) 579-8400 A. SUMMARY OF WARNINGS AND CAUTIONS Caution: Federal law restricts this device to sale by or on the order of a physician. While operating personnel must become thoroughly familiar with all instructions in this manual, all statements preceded by the following words have special significance. WARNING Indicates that there is a possibility of personal injury to the operator and/or the patient CAUTION Indicates that there is a potential for | damage to the equipment and/or other | property if the precaution is ignored. |NOTE: Indicates points of particular interest which are intended to supplement the basic instructions for more efficient and/or convenient operation. INFANT VENTILATOR WARNINGS SUMMARIZED Whenever a patient is connected to the ventilator, constant attendance is required by qualified personnel. The use of this ventilator with its built-in alarms and/or with additional alarn systems does not provide absolute assurance of warning for every type of malfunction that may occur in the patient/ventilator system. In addition, some problems may require immediate attention. Never use the Sechrist Infant Ventilator without the Safety Pressure Relief Valve installed and adjusted to the patient's needs. Verify that the exposed valve stem is not obstructed in any way; do not tape or occlude the vent holes drilled through the valve body or the valve will be rendered inoperative. The Safety Pressure Relief valve constitutes a back-up safety system intended to limit the pressure in the patient breathing circuit in the event that the patient circuit tubings become kinked or occluded. Verify that all patient circuit tubings are free fron kinks or obstructions and that the valve stem is not obstructed in any way before connecting the patient to the ventilator, and throughout operation to insure patient safety. only use replacement parts provided or approved by Sechrist Industries, Inc. The patient breathing circuit components provided with the Sechrist Infant Ventilator are shipped assembled, in clean but not sterile condition. Upon receipt, the patient breathing circuit should be completely disassembled and thoroughly cleaned and/or sterilized prior to use. Oxygen vigorously accelerates combustion; do not use any service instruments or other equipment that may have been exposed to oil or grease contamination to avoid explosion hazard. The Main Power Switch is also a resettable 0.25 Amp circuit breaker. If the switch trips off during operation, the circuit breaker can be reset by manually depressing the switch to the "oN" position. If the switch continues to trip, the ventilator should be removed from service and referred to a qualified service technician. Always monitor oxygen concentrations with an accurate oxygen analyzer with high and low (FI02) alarms to be assured that the desired FIO2 is being delivered to the patient.Always mount the humidifier below the level of the patient and position the patient circuit so that condensate does not drain toward the patient or accumulate in the patient circuit. We recommend that the humidifier be located on the stand pole as low as possible. This position will allow the inspiratory patient hose to be draped in such a manner that the condensate in the hose will drain back to the humidifier. Routine maintenance procedures contained in this manual may involve opening the ventilator enclosure which constitutes an ELECTRICAL SHOCK HAZARD. These procedures must be performed by qualified personnel. INFANT VENTILATOR CAUTIONS SUMMARIZED Do not permit pressure to build on the ventilator manometer gauge beyond the indicated pressure range, as the gauge may be permanently damaged due to overpressure. Moving parts within the manometer gauge are subject to wear in normal use which may lead to inaccurate or erratic gauge performance over time. Periodic replacement of the manometer is recommended for best performance. Ethylene oxide is toxic. Parts thus sterilized must be properly aerated to dissipate the residual toxic gas absorbed by the material. Follow the sterilizer manufacturer's recommendations for the specific aeration periods required. Verify that the Safety Pressure Relief Valve operates freely after cleaning/sterilization by manually opening the valve. The competence of the Pediatric Exhalation Valve depends on the seal created by the metal-to-metal contact of a seat and poppet. These contacting surfaces should be handled carefully so they are not scratched or nicked in such a way as to cause leaks. It should also be noted that the diaphragm retaining cap of the Pediatric Exhalation Valve (blue) is not interchangeable with that of the standard exhalation valve (white). The Pediatric Valve Block is easily distinguished from the standard valve block by the letter "p" machined into the top surface. Do not subject clear plastic exhalation valve blocks to temperatures above 140'F or they will be damaged. Liguid water in the compressed air supply can cause malfunction of this equipment. If the ventilator is connected to A.C. power and a 12 volt battery at the same time, the internal 12 V.D.C. batteries (alarm backup) will NOT be charged. In fact, the battery will be used until its voltage drops to approximately 9.5 volts which will not provide sufficient backup power to sustain the alarm system in the event of total power failure. Therefore, we recommend that only one power source be connected at any time.zaunold @O00L-Al JILWWIHIS 1V8INID ANGI waviw ‘ONIHOLINOW aunssaud aATWA rates aingdow ONDAW NOUVIVHXa Sainte Mousyd W31SAS 1ON1NOD wOssaz0NdONDIW anaow JOULNOD YOLVTILNSA [LdThe mode switch must be turned off whenever the A.C. power is turned off or the alarm backup batteries will be discharged. Stretching the Smoothbor tubes may result in permanent damage to the tubing. Use care when disassembling the patient circuit. Do not attempt to push the diaphragm in place with the retaining cap. This will distort the seal ring. The retaining cap should have the o-ring seal in place before inserting. Do not stretch the diaphragm to test the competence of the diaphragm as it will tear; use the Performance Verification Procedure to functionally test the competence of the assembled exhalation valve. An active gas scavenging system should be tested with the ventilator before use to verify that it does not scavenge gas from within the patient circuit and create sub-ambient pressures.2 OPERATING INSTRUCTIONS A. GENERAL DESCRIPTION Sechrist Model IV-100B Infant Ventilator is a sophisticated instrument designed for use by properly trained and qualified personnel. It is restricted to use by or upon the direction of a physician. Before attempting to use this device in an actual life support situation, the operating Personnel must become practiced in the function and effect of the various controls. The Sechrist Model IV-100B Infant Ventilator is a continuous flow, time cycled controller. The ventilator system is shown schematically in Figure 2. Sources of air and oxygen are supplied to the Air-oxygen Mixer module where the desired FI02 and continuous flow rate are selected. The gas flow is typically directed from the gas mixing module through a humidifier (not included) where it is humidified and warmed to physiological values. The humidified mixed gas flows past the patient connection to ambient through an exhalation valve. Inflation of the patient's lungs is accomplished by closing the exhalation valve, thus creating a pressure increase at the patient connection. Exhalation occurs when the exhalation valve is opened. The exhalation valve is the principle active component which controls pressures created within the patient circuit. During the inspiratory phase, the ventilator generates a fluidic control pressure that closes the exhalation valve, thereby containing the flow of gas within the patient circuit. Pressure within the patient circuit increases resulting in the insufflation of the patient's lungs as pressure builds at the patient connection. During exhalation, the continuous flow of gas flushes carbon dioxide from the patient connection. Figure 5 illustrates the design of the Hi/Lo Exhalation Valve in cross section. The gas flows into the exhalation valve from the "PATIENT CONNECTOR" as indicated in the figure. The gas flows through the "INJECTOR THROAT" and "VALVE SEAT" past the "CONTROL DIAPHRAGM" to ambient through holes drilled into the bottom of the valve block. The small space behind the control diaphragm (side opposite the valve seat) is sealed and connected directly to the fluidic control system in the ventilator. When a pressure signal is generated during the inspiratory phase, the diaphragm moves forward to occlude the valve seat. Pressure builds in the patient circuit until an equilibrium is reached between the forces created by the control pressure and the circuit pressure. The continuous flow will then be vented toambient at a specific pressure. A fluidic control system allows the operator to control the pressure of the gas signal applied to the diaphragm in the exhalation valve throughout the breath cycle, thereby establishing the inspiratory and expiratory pressures. The "INSP. PRESS" control establishes the control pressure corresponding to the peak inspiratory pressure (PIP) during the inspiratory phase and the "EXP. PRESS." control establishes the control pressure corresponding to the end expiratory pressure level during the expiratory phase. When it is desired ‘to have zero end expiratory pressure (ZEEP), the inherent resistance to gas flow of the expiratory limb of the patientcircuit must be eliminated. This is accomplished in the Sechrist Infant Ventilator by creating a slightly negative pressure at the patient side of the exhalation valve. The INJECTOR JET (refer to figure 5) directs high velocity gas through the INJECTOR THROAT which thereby generates a lower pressure on the patient side of the exhalation val The sub-ambient pressure produced is sufficient to eliminate inadvertent PEEP due to resistance to gas flow through the patient breathing circuit provided. A microprocessor-based control system allows the operator to select the duration of the inspiratory and expiratory periods using the INSP. TIME and EXP. TIME controls respectively. The times selected by the operator with the corresponding controls are displayed on the control panel. The microprocessor automatically calculates the I:E Ratio and Breath Rate which are also displayed above the inspiratory and expiratory times respectively. For a detailed explanation of the Air/oxygen Mixer, Fluidic Control system and Microprocessor Control Circuit, refer Section 7 - Understanding Guide. e 5 The "MANUAL" push button enables the operator to deliver a manual breath at the preset pressure limits whenever desired. The manual breath button is completely independent of the electronics and can be used to cycle the ventilator in the event of a power failure. ‘The inspiratory phase will last as long as the button is depressed; releasing the button allows the exhalation valve to open. The Sechrist Infant Ventilator incorporates a Digital Electronic Manometer which provides the following functions: Bar Graph Display of Airway Pressure Digital Display of Mean Airway Pressure Low Pressure Alarm High Pressure AlarmThe Bar Graph Display simulates the needle movement of a mechanical gauge to indicate the pressure being measured. Each segment of the display represents 1 cm H20. The Digital Display normally indicates the mean Airway Pressure. The display is updated on a breath by breath basis and the value shown is the average of the Mean Airway Pressure measured during the last four breaths. The Low Pressure Alarm Limit value may be set by the operator to provide audible and visible alarms for the following situations: Low Airway Pressure (leaks) Loss of Airway Pressure (patient disconnect) Failure to Cycle (microprocessor failure) Power Failure (AC or DC operation) Apnea (under certain CPAP conditions) Prolonged Inspiration Source Gas Failure (both gases lost) The High Pressure Alarm Limit value may be set by the operator to provide immediate audible and visible alarm indications whenever the High Pressure Limit value is reached by the measured pressure. The digital manometer/alarm system is operational in both the "VENT" and "CPAP" modes and is powered by Ni-cad batteries incorporated in the ventilator in the event of a power failure. The Sechrist Infant Ventilator requires sources of Medical Breathing Air and USP oxygen (both at a nominal pressure of 50 PSI at 1.5 SCFM). The gas inlets conform to the Diameter Index Safety System (D.I.S.S.) as do the supply hoses provided with the ventilator. Both gas inlets incorporate 7 micron sintered stainless steel filters and a 0.1 micron filter/water trap assembly is provided for the air inlet. The Sechrist Infant Ventilator requires an AC power source at 115 VAC, 50 or 60 Hz (overseas power requirements available) and some types can be operated from a 12 VDC Power supply using the accessory power cable provided. The main power switch on the back of the ventilator also serves as a resettable protection circuit breaker.B. DESCRIPTION OF CONTROLS 1. AIR-OXYGEN MIXER: This system consists of an air- oxygen proportioning device and flowmeter systen. The supply gas hoses are used to connect Medical Breathing Air and Oxygen gas supplies to the D.I.S.S. connections on the rear of the gas mixing module. Gas supply pressures should be nominally 50 psi. Variations of + 20 psi between the gas supply pressures will not affect the accuracy of the Mixer by more than + 1%. FIO2 is selected with the proportioning valve control knob and flow of mixed gas into the patient circuit is controlled with the flowmeter. WARNING The Air-oxygen Mixer of the Sechrist Model IV-100B Infant Ventilator are designed to use Medical Breathing Air and Oxygen only. Do not modify these inlets to use other breathing or anesthetic gases. WARNING Liquid water in the compressed air supply can cause malfunction of this equipment. | Please consider the air supply a Medical Breathing Air rather than compressed air. In most cases, someone is forced to breathe what is entering the equipment! NOTE: Flowmeters provided are not back pressure compensated. IARNING Oxygen concentrations must be monitored at or near the proximal airway with an accurate oxygen analyzer with high and low (FI02) alarms to be assured that the desired FI02 is being delivered to the patient. n2. SAFETY PRESSURE RELIEF VALVE: The Sechrist Safety Pressure Relief Valve is installed in the inspiratory limb Of the patient breathing circuit and is mounted in the back of the flowmeter assembly in all three gas mixing configurations. Relief pressures between 15 and’85 cm 20 can be obtained by adjusting the relief valve. Relics Pressure is increased by rotating the white (Delrin’) internal spring which holds the valve closed. Rotating the adjuster in a counterclockwise direction will decrease Relief pressure. The valve stem is extended so that it can gpexator. The valve can be removed and disassembled tor cleaning or sterilization as required. This valve mucc be checked and adjusted for each patient. WARNING NEVER USE THE SECHRIST INFANT VENTILATOR WITHOUT THE SAFETY PRESSURE RELIEF VALVE INSTALLED AND ADJUSTED TO THE PATIENT'S NEEDS. VERIFY THAT THE EXPOSED VALVE STEM OPERATES FREELY AND IS NOT OBSTRUCTED IN ANY WAY; DO NOT TAPE OR OCCLUDE THE VENT HOLES DRILLED THROUGH THE VALVE BODY OR THE VALVE WILL BE RENDERED INOPERATIVE. sen iL POWER SWITCH: The A.c. power is switched on or oft with a rocker switch located on the back panel. a,c. Power ust Peon for the ventilator to operate. This will bo indicated by the lighting of one of the mode lights on the front panel. NOTE: When A.C. power is switched off, it may take Powerat minutes for the mode lights to turn off. Tne A.c. Power switch can be off when a D.C. power source is used. WARNING The Main Power Switch is also a resettable circuit breaker. If the switch trips oft guring operation, the circuit breaker can be reset by manually depressing the switchto the "ON" position. If the switch continues to trip, the ventilator should be removed from service and referred to a qualified service technician. 4 MODE SELECTOR: The mode selector is an electronic switch with three positions. The OFF position disables all electronic function. In the CPAP position, only the alarm system is functional. In the VENT mode, all alarms, displays and electronic contols are functional. The mode selector has no control over the gas supply (ie., will not turn the gas supply on or off). CAUTION The mode switch should always be turned off whenever the A.C. power is turned off or the alarm back-up batteries will be discharged. 5. MANUAL BREATH: The manual breath push button may be used to develop inspiratory pressure whenever the gas supply to the ventilator is present and there is flow through the patient circuit. The inspiratory pressure developed will be limited to the setting of the inspiratory pressure control. Inspiration will occur as long as the button is pushed. Use of the manual control will not synchronize the electronic timing circuit. 6. INSPIRATORY PRESSURE: The inspiratory pressure control is a single turn control which adjusts the signal pressure to the exhalation valve diaphragm, thereby controlling the maximum pressure attainable in the patient circuit. The nominal range of adjustment is from 5 to 70 cm H20. If necessary, the control can be internally recalibrated (QUALIFIED SERVICE PERSONNEL ONLY) to higher or lower values. The selected pressure is slightly flow-variable. Pressure may vary + 1 to 2 cm H20 as flow is increased or decreased. 14NOTE: Verify that the Safety Pressure Relief Valve is set correctly if it is not possible to achieve the desired inspiratory pressure. NOTE: Inspiratory and expiratory pressures obtainable with a particular ventilator/patient system are influenced by a number of factors including but not limited to the following: Resistance and compliance of the patient and breathing circuit system - Flow rate Waveform Adjustment (see part 2.F.) Inspiratory and expiratory time settings - Safety pressure relief valve setting. Inspiratory and expiratory pressure ranges published in this manual only express the nominal performance of the ventilator under a particular set of controlled conditions. 7. EXPIRATORY PRESSURE: This control allows the operator to select a desired CPAP level whenever the ventilator is used as a CPAP-only device. In the VENT mode this control is used to select negative, zero or positive end expiratory pressure. The nominal control range is from -2 to 15 cm H20. This expiratory pressure is also slightly flow-dependent. It will vary + 1 to 2 cm H20 as flow is varied. Negative pressure cannot be obtained if the continuous flow in the patient circuit is greater than approximately 20 to 24 L.P.M. (when the standard Hi/Lo Flow Exhalation Valve/Patient Circuit are used; P/N IV-335). 8. EXPIRATORY TIME: The expiratory time is selected with a ten-turn linear potentiometer. The total range of this control is from 0.30 sec. to 60.0 sec. The range of 0.30 sec. to 1.50 sec. is adjustable in 0.01 sec. increments. The range of 1.50 sec. to 10.0 sec. is adjustable in 0.1 sec. increments. The range of 10.0 sec. to 20.0 sec. is adjustable in 1.0 sec. increments and the range of 20.0 sec. to 60.0 sec. is adjustable in 5.0 sec. increments. The accuracy and repeatability of the selected time is within 0.05%. The expiratory time is displayed above the "EXP. TIME" control. 9. INSPIRATORY TIME: The inspiratory time is selected with a ten-turn linear potentiometer. The total range of this control is from 0.10 sec to 2.90 sec. The range of 0.10sec. to 1.00 sec. is adjustable in 0.01 sec. increments. The range of 1.00 sec. to 2.90 sec. is adjustable in 0.1 sec. increments. The accuracy and repeatability of the selected time is within 0.05%. The inspiratory time is displayed above the "INSP. TIME" control. 10. ALARM SELECT BUTTON: This button allows the operator to select either the LO LIMIT alarm pressure value or the HI LIMIT alarm pressure value for adjustment. Pressing the button once will change the digital display of the electronic manometer from MEAN to Lo LIMIT, as indicated by lighting the appropriate annunciator. Pressing the button again will change the display to HI LIMIT as indicated by the annunciator. Whenever one of the annunciators has been selected, it is possible for the operator to adjust the selected value with the UP and DN buttons. The Select button is also used to cancel a HI LIMIT alarm when this alarm is activated. 11. ALARM UP/DN BUTTONS: These buttons will adust the alarm limit value for the parameter which has been selected by the SELECT button. If neither of the buttons are pressed within a 3 second period, the digital display reverts to the display of mean Airway Pressure. 12. LO LIMIT PRESSURE ALARM SETTING: This setting establishes the set point for the LO LIMIT alarm systen. The alarm set point is indicated by the lighting the appropriate segment of the bar graph display whenever the measured pressure is less than the Lo LIMIT value and blanking the segment whenever the measured pressure is greater than the limit value. In the VENT mode, the set point should be located 1 to 2 cm H20 below the maximum pressure reached during the inspiratory phase as indicated by the bar graph display. The measured pressure must pass the set point within the selected delay time (see item 11) to prevent an alarm indication. It may be possible to use the alarm system in the CPAP mode if the patient's spontaneous inspiratory breathing effort is sufficient to deflect the measured pressure approximately 1 to 2 cm H20. Position the set point 1 to 2 cm H20 below the CPAP baseline such that the patient's spontaneous effort will draw the measured pressure to or below the set point during inspiration. The LO LIMIT set point must be reached or passed by the measured pressure before the delay time is exceeded or the audible and visible alarms will be activated. 13. HI LIMIT PRESSURE ALARM SETTING: This setting establishes the set point for the HI LIMIT alarm systen.The alarm set point is indicated by the lighting the appropriate segment of the bar graph display whenever the measured pressure is less than the HI LIMIT value and blanking the segment if the measured pressure is greater than the limit value. In the VENT mode, the set point should be located approximately 5 to 10 cm H20 above the peak measured pressure displayed on the bar graph. [If the measured pressure reaches or exceeds the HI LIMIT value, an alarm situation is immediately indicated by the audible and visible indicators. 14. MEAN AIRWAY PRESSURE DISPLAY: This three digit numeric display normally displays the Mean Airway Pressure as measured in the patient circuit. The display is updated every breath and indicates the average Mean Pressure for the latest four breaths. When the Select button is pressed, this display will indicate the current numeric value for the LO LIMIT pressure value or the HI LIMIT pressure value. 15. ALARM DELAY TIME: This control sets the time delay before the LO LIMIT audible and visible alarms are activated. The delay time is actually the maximum tine interval between subsequent interruptions of the LO LIMIT set point by the measured pressure. The time is adjustable from 3 to 60 seconds. The audible and visible alarms will activate at the end of the alarm delay time if the measured pressure has not passed the alarm set point during the delay tine. 16, ALARM VISIBLE INDICATOR: This light will flash red during an alarm situation. Simultaneously, an audible beep will be heard. Distinction between the type of alarn, either LO LIMIT or HI LIMIT can be determined by observing the lighted annunciator of the electronic manometer. 17. ALARM MUTE: Pushing this button will silence the audible alarm indicator for approximately 30 seconds. The audible indicator will automatically re-activate at the end of the mute period if an alarm condition continues to exist. It is intended for use during suctioning procedures so that the alarm delay time knob position need not be disturbed. 18. TEST: Pushing this button when the ventilator is operating in the "VENT" mode will initiate a self-test sequence. As the button is pressed, the audible and visible alarms are momentarily activated. The digital displays index collectively through a count sequence such that all display segments and the microprocessor programming are tested. Also, all segments and annunciators of the electronic manometer are lit. 17