Health Devices IPM System

INSPECTION AND PREVENTIVE MAINTENANCE

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Procedure No. 458-20010301 (Combined)

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Critical Care Ventilators

Used For:
Ventilators, Intensive Care [17-429]
Ventilators, Intensive Care, Neonatal/Pediatric [14-361]
Ventilators, Transport [18-098]

______________________________________________________________________________________

Also Called: Respirators

Commonly Used In: Critical care units, general medical/surgical units, emergency departments

Scope: Applies to all ventilators except jet ventilators, negative-pressure ventilators, portable
ventilators (see Procedure 471), and anesthesia unit ventilators (see Procedure 461)

Risk Level: High

Type Interval Time Required

Major 6 months _____ hours

Minor Not Applicable

Notes:
Interval Note: Inspection and preventive maintenance intervals should be scheduled according to the
manufacturer's recommendations, which may be related to hours of use. However, units should have
a major inspection at least every six months. Pre-use checks should be performed by a respiratory
therapist or respiratory equipment technician.
_______________________________________________________________________________________

Overview
Mechanical ventilators are used to compensate
for deficiencies in normal breathing. A ventilator
may aid or augment spontaneous breathing or
may completely regulate a prescribed breathing
pattern for patients who cannot breathe for
themselves. Most modern ventilators use
positive-pressure inflation of the lungs to
accomplish these functions.
The ventilator provides direct control of the
patient's ventilatory variables, as well as other
variables (e.g., the concentration of inspired
oxygen), and the limits on certain variables for
Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
safe operation. All these controls allow the
clinician to provide better patient management,
even for patients with serious respiratory
impairments.
A mechanical ventilator is composed of four basic
subsystems: the ventilator and its controls;
monitors and alarms; gas supply; and patient
circuit (which includes the breathing circuit and
may include a humidifier and nebulizer). Each
subsystem requires its own inspection and
preventive maintenance procedures.
Citations
Page 1 of 8
 Procedure No. 458-20010301 Critical Care Ventilators (Combined)
(from Health Devices if not otherwise
noted)
Inadequate pressure relief in infant ventilators
[Hazard], 1983 Apr;12:150-1.
Leaving ventilator-dependent patients
unattended [Hazard], 1986 Apr;15:102-3.
Infant ventilators [Evaluation], 1986
Aug;15:219-46.
Remote alarms for ventilators and other life-
support equipment, 1986 Dec;15:323-4.
Microprocessor-controlled third-generation
critical care ventilators [Evaluation], 1989
Feb;18:59-83.
Intensive care ventilators [Evaluation], 1998
Sep-Oct;27:308+.
Minimum requirements for ventilator testing
[Guidance article], 1998 Sep-Oct;27:363+.
Mis-set ventilator alarms can be lethal [Hazard]
1999, Apr;28:165.
Intensive care ventilators [Update evaluation]
2000 Jul-Aug;29:247+.
Test Apparatus, Supplies,
Parts
 Ground resistance ohmmeter (Major,
Acceptance)
 Leakage current meter or electrical safety
analyzer (Major, Acceptance)
 Lung simulator with adjustable
compliance/ventilator tester (Major,
Acceptance)
 Pressure gauge or meter with 2 cm H2O
resolution from -20 to +120 cm H2O (Major,
Acceptance)
 Oxygen analyzer (Major, Acceptance)
 Various breathing circuit adapters (Major,
Acceptance)
 Syringe (1.5 L) (Major, Acceptance)
 Items required for manufacturer's tasks
(Major, Acceptance)
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 review special
inspection and preventive maintenance
Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
procedures or frequencies recommended by the
manufacturer.
Many microprocessor-controlled ventilators have
self-diagnostic programs. When the ventilator's
hardware (e.g., solenoid valves, transducers) is
checked by its own software, manual inspection
tasks can be eliminated.
Manufacturers' recommended procedures for
inspection and preventive maintenance of
mechanical ventilators vary in both methods and
required accuracy. In addition, ventilation
modes, controls, and algorithms for calculated
variables vary greatly according to manufacturer
and model. This procedure provides the basic
framework for complete ventilator inspection and
preventive maintenance. Manufacturers'
recommended procedures should be added
where appropriate. Several tasks, particularly
Operational Modes, Controls, and Monitored
Parameters and Alarms, should be customized to
make a procedure that is model-specific.
Qualitative Tasks
Chassis/Housing. Check for shipping
damage; report any damage to the
manufacturer, shipper, or service organization,
and arrange for repair or replacement.
Check that the ventilator is suitably constructed
to withstand normal hospital use and abuse. For
instance, a unit with venting on the top of the
housing or poorly protected or sealed controls
and indicators may be prone to fluid entry. (Such
design deficiencies should usually be recognized
during prepurchase evaluation. However, if any
are evident, discuss corrective action with the
manufacturer. If not correctable, warn users or
take other preventive measures.)
Examine the exterior of the ventilator for
cleanliness and general physical condition.
Ensure that plastic housings are intact, that all
assembly hardware (e.g., screws, fasteners) is
present and tight. (Acceptance)
Chassis/Housing. Examine the exterior of
the ventilator 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. (Major)
Mount/Fasteners. Ensure that the
assembly and weight distribution is stable and
that the ventilator will not tip over when pushed
or when a caster is jammed on an obstacle (e.g.,
line cord, threshold), as may occur during
transport. If the ventilator is designed to rest on
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 Procedure No. 458-20010301 Critical Care Ventilators (Combined)
a shelf, ensure that it has nonslip legs or
supports.
If the ventilator is mounted on a stand or cart,
examine the security of the mount. Check the
mounting security of all components or attached
monitors. (Acceptance)
Mount/Fasteners. If the ventilator 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. Check the mounting security of all
components or attached monitors. (Major)
Casters/Brakes. Verify that the correct
casters have been supplied with the ventilator
(e.g., size, correct swivel). (ECRI recommends 5
in [12.7 cm] diameter casters for mobile
ventilators to reduce shock to the unit and to
minimize the effort required to roll the ventilator
across elevator thresholds and other uneven
surfaces.) Verify caster and brake operation.
(Acceptance)
Casters/Brakes. If the ventilator 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 ventilator is so equipped.
(Major)
AC Plug. A solidly constructed, good quality
plug with adequate strain relief is acceptable, but
the use of a Hospital Grade plug (identifiable by
a green dot and/or labeling) will eliminate
guesswork and ensure a plug of acceptable
construction quality. Right-angle plugs are
unacceptable for devices that are moved
frequently. A good quality two-prong plug is
acceptable for double-insulated devices. Replace
the plug or have the supplier replace it if it is not
Hospital Grade or otherwise suitable. Hospital
Grade molded plugs are acceptable.
Examine the AC power plug for damage. Attempt
to wiggle the blades to determine if they are
secure. Shake nonmolded plugs and listen for
rattles that could indicate loose screws.
(Acceptance)
AC Plug. 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. (Major)
Line Cord. Ensure that the line cord is long
enough for the ventilator's intended application;
an extension cord should not be required. (A
Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
length of 10 ft [3 m] is suitable for most
applications, although 18 ft [5.5 m] has been
suggested for operating room equipment.)
The cord should be of suitable quality and
current-carrying capacity. Hard Service (SO, ST,
or STO), Junior Hard Service (SJO, SJT, or
SJTO), or an equivalent-quality cord should be
used.
Verify that the ventilator has adequate
protection against power loss (e.g., from
accidental disconnection of a detachable power
cord, disconnection of the power cord from the
wall, or depleted battery if a battery-powered
device is not plugged in). Equipment having a
detachable power cord should also have
adequate capture devices, cleats, or channels to
hold the cord in place. If these are absent,
request that the supplier provide suitable means
of securing the cord. Verify that the ventilator
has adequate alarms or indicators for line-power
loss and battery depletion and an adequate
battery-charging indicator. (Acceptance)
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 correct polarity. Also, check
line cords of battery chargers. (Major)
Strain Reliefs. Examine the strain reliefs at
both ends of the line cord. Be sure that they hold
the cord securely. (Major, Acceptance)
Circuit Breaker/Fuse. If the ventilator
has a switch-type circuit breaker, check that it
moves freely. If the ventilator is protected by an
external fuse, verify that the fuse type is labeled
and that all fuses and spares are the proper
current rating and type. If the value and type are
not labeled, check the manual for the proper
current rating and type and permanently mark
this information on the ventilator housing near
the fuse holder.
Especially for critical or life-support devices,
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. If this is not
available, then consider labeling the primary
device to clearly indicate where the ventilator's
fuse or circuit breaker is located, and/or install a
fused Hospital Grade (or similar quality) plug on
any commonly used accessories that are not
already provided with suitable overcurrent
protection. (Acceptance)
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 Procedure No. 458-20010301 Critical Care Ventilators (Combined)

Circuit Breaker/Fuse. If the ventilator
has a switch-type circuit breaker, check that it
moves freely. If the ventilator is protected by an
external fuse, check its value and type against
that marked on the chassis and ensure that a
spare is provided. (Major)
Filters. Check the condition of gas filters.
Check for corrosion residue indicative of liquid,
gaseous, or solid particle contaminants in the
gas supply; advise appropriate personnel if
found. Clean or replace if appropriate, and
indicate this on the inspection form. (Major)

Tubes/Hoses. Check the condition of all Controls/Switches. Verify that setup

tubing and hoses. They should be clean and parameters accessible through hidden or service
intact. (Major, Acceptance) menus are correctly set for the appropriate
application and are consistent with other units of
Cables. Inspect any cables and their strain the same model. Instruction and service manuals
reliefs for general condition. (Acceptance) may contain instructions regarding such menus.
If they do not, contact the manufacturer. Discuss
appropriate settings with the department head
Cables. Inspect any cables and their strain
and users. If alarm capabilities are included, see
reliefs for general condition. Carefully examine
the Acceptance test for Alarms.
cables to detect breaks in the insulation and to
ensure that they are securely gripped in the
Examine all controls and switches for physical
connectors at each end, which will prevent
condition, secure mounting, and correct motion.
rotation or other strain. Where appropriate,
If a control has fixed-limit stops, check for
verify that there are no intermittent faults by
proper alignment, as well as positive stopping.
flexing cables near each end and looking for
(Acceptance)
erratic operation or by using an ohmmeter.
(Major)
Controls/Switches. Before changing any
controls or alarm limits, check their positions. If
Fittings/Connectors. Verify appropriate
any settings appear inordinate (e.g., alarm limits
connectors are supplied if connection to other
at the ends of their range), consider the
hospital equipment or systems is required.
possibility of inappropriate clinical use or of
Ventilators that connect to the central piped
incipient device failure. Investigate questionable
medical gas system should have the matching
control settings on a home care ventilator.
DISS or quick-connect fitting for the appropriate
Consult with the patient's physician to determine
gas. Verify that suitable connectors are supplied
correct settings. The patient or caregiver should
with the ventilator so that adapters are not
receive additional training, if required. Record
required.
the settings of those controls that should be
returned to their original positions following the
Examine all gas and liquid fittings and
inspection.
connectors, as well as all electrical cable
connectors, for general condition. Electrical
Examine all controls and switches for physical
contacts should be straight, clean, and bright.
condition, secure mounting, and correct motion.
Gas and liquid fittings should be tight and should
Check that control knobs have not slipped on
not leak. If keyed connectors are used (e.g., pin-
their shafts. Where a control should operate
indexed gas connectors), ensure that no pins are
against fixed-limit stops, check for proper
missing and that the keying is correct. Keying
alignment, as well as positive stopping. Check
pins should be securely seated in "blind" holes so
membrane switches for damage (e.g., from
that they cannot be forced in farther.
fingernails, pens). During the inspection, be sure
(Acceptance)
to check that each control and switch performs
its proper function. (Major)
Fittings/Connectors. Examine all gas
fittings and connectors for general condition. Gas
Pressure-Relief Mechanism. Check the
fittings should be tight and should not leak.
proper operation of the pressure-relief
Verify that keyed connectors (e.g., pin-indexed
mechanism, if so equipped, by occluding the
gas connectors) are used where appropriate,
breathing circuit and observing the resulting
that all pins are in place and secure, and that
peak pressure on the unit's pressure indicator.
keying is correct. Connectors to hospital central
Verify that pressure is vented and does not
piped medical gas systems should have the
exceed manufacturer specifications. (Major,
appropriate DISS or quick-connect fitting to
Acceptance)
eliminate the need for adapters. (Major)

Filters. Ensure that all gas filters are supplied.
Check their condition. (Acceptance)
Fan/Compressor. Check the physical
condition and proper operation of these
components, if so-equipped. Check for automatic
activation of the compressor when the piped gas

Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
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 Procedure No. 458-20010301 Critical Care Ventilators (Combined)
supply pressure falls below operating pressure.
(Acceptance)
Fan/Compressor. Check the physical
condition and proper operation of these
components if so-equipped. Check for automatic
activation of the compressor when the piped gas
supply pressure falls below operating pressure.
Clean or replace fan and/or compressor filters
and lubricate as required, according to the
manufacturer's instructions. (Major)
Power Continuity. [Delete this task if the
ventilator operates on battery power.]
To ensure constant ventilation when line power
is interrupted, ventilators should automatically
switch to battery operation. If the unit is not
equipped to do this, it should be connected to an
uninterruptible power supply (UPS). A UPS,
however, is inconvenient, can be lost or
overlooked, and must be accounted for in
inventory control and equipment maintenance. A
UPS should be periodically checked to ensure
proper operation. Because of the added expense
and the other disadvantages inherent in using a
UPS, ventilators should be purchased with
internal batteries when possible. (Acceptance)
Battery/Charger. Determine the
replacement interval for all batteries and
document the interval(s) in an equipment control
system or a hard copy file for the ventilator. Be
sure to include batteries/cells for clocks and/or
memory logs. Disconnect the battery and
determine that the ventilator still operates on
line power.
Operate the ventilator on battery power for
several minutes to verify that the battery is
charged and can hold a charge. Activate the
battery test function, if so equipped. Check the
condition of the battery charger, and verify that
battery charge indicators function. Provide users
with instructions and/or checklist procedure to
ensure adequate battery charging and
performance. (Acceptance)
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 ventilator on battery power for
several minutes to check that the battery is
charged and can hold a charge. (The inspection
can be carried out on battery power to help
confirm adequate battery capacity.) Check
battery condition by activating the battery test
function or measuring the output voltage; for
lead-acid batteries, measure the specific gravity
and check the fluid level. Check the condition of
the battery charger and, to the extent possible,
Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
confirm that it does, in fact, charge the battery.
Be sure that the battery is recharged or charging
when the inspection is complete. When it is
necessary to replace a battery, label it with the
date. (Major)
Indicators/Displays. Confirm the
operation of all lights, indicators, meters,
gauges, and visual displays on the ventilator and
charger (if so equipped). Be sure that all
segments of a digital display function. Record
reading of an hour meter, if present. (Major,
Acceptance)
Alarms. Verify that configurable alarm
features are appropriately set and consistent
among all ventilators. It should not be possible
for critical alarms to be turned off, silenced, or
defeated without adequate warning to the
operator or automatic alarm reactivation after a
short delay. Such deficiencies should usually be
recognized during prepurchase evaluation.
However, if any are found, review the
justification for purchasing this ventilator and
discuss corrective action with the manufacturer.
(Alarm features may be optional or
programmable.) If no remedy is available, a user
training program should be instituted to reduce
the risk of incorrect use. A warning label on the
ventilator or a poster in the area of use may be
appropriate. If the ventilator has an alarm-
silence feature, check the method of reset (i.e.,
manual or automatic) against the manufacturer's
specifications. (Acceptance)
Audible Signals. Verify that alarms are
loud, distinctive, and/or bright enough to be
noticed in the environment in which the
ventilator will normally be used. If a remote
alarm-indicator is required, verify that it is
available and functioning. Audible alarm-volume
controls should not allow the alarm to be turned
off or lowered to an indiscernible volume.
(Acceptance)
Operational Modes. [Note: This task
should be customized into specific tasks for each
mode, which will create corresponding task titles
on the inspection form.]
Verify proper operation of the following modes
found on most ventilators:
Control
Assist/control
Synchronized intermittent mandatory ventilation
(SIMV)
Pressure support
Continuous positive airway pressure/positive
end-exhalation pressure (CPAP/PEEP) (Major,
Acceptance)
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 Procedure No. 458-20010301 Critical Care Ventilators (Combined)
Labeling. Check that all necessary placards,
labels, and instruction cards are present and
legible. (Major, Acceptance)
Accessories. Verify that all necessary
features and accessories have been supplied with
the ventilator. Verify that the breathing circuit
and filters are compatible with the ventilator
according to the manufacturer's
recommendations. Check for leaks in the
breathing circuit, ensuring that fittings, adapters,
and other components (e.g., exhalation valves,
H-valves, PEEP valves, water traps, nebulizers)
are properly assembled and functioning
correctly.
At least one copy each (two are generally
preferred) of the instruction and service
manuals, including schematics, should be
shipped with the unit and filed in the central
equipment file. A copy of the operator's manual
should be kept with the ventilator and read by all
operators before the ventilator is put in use.
(Acceptance)
Accessories. Confirm the presence and
check the condition of accessories. Verify that
the breathing circuit and filters are compatible
with the ventilator according to the
manufacturer's recommendations. Check for
leaks in the breathing circuit, ensuring that
fittings, adapters, and other components (e.g.,
exhalation valves, H-valves, PEEP valves, water
traps, nebulizers) are properly assembled and
functioning correctly.
Oxygen-air proportioner. See Procedure 444.
(Major)
Compressor. Test according to the
manufacturer's recommendations. (Major,
Acceptance)
Gas Cylinders, Gauges, and
Regulators (for transport
ventilators). Verify that these components
are present, securely mounted, and in good
condition and that there is adequate gas supply.
(Major, Acceptance)
Humidifiers. See Procedure 431. (Major,
Acceptance)
Quantitative Tasks
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
Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
and exposed (unpainted and not anodized) metal
on the chassis. We recommend a maximum of
0.5 . If the system is modular or composed of
separate components, verify grounding of the
mainframe and each module or component.
(Major, Acceptance)
Chassis Leakage Current. Note: Some
devices (especially devices incorporating a
microprocessor, motor, or compressor) may be
damaged by switching polarity while the device
is on. If you perform reverse polarity testing,
turn off the ventilator until the motor stops or for
at least 10 sec before switching polarity.
Although reversed polarity testing is not
required, it may be advisable on a ventilator of
questionable quality or on ventilators used in the
home.
With the polarity of the power line normal and
the equipment ground wire disconnected,
measure chassis leakage current with the
ventilator operating in all normal modes,
including on, standby, and off. If the ventilator
has a UPS, readings should be taken with the
UPS connected. Record the maximum leakage
current; it should not exceed 300 A for patient-
care equipment used in a patient-care vicinity
[NFPA 99 7-5.1.3.5(a)].
The measurements should be made with all
accessories that are normally powered from the
same line cord connected and turned on. This
applies to devices that are plugged into
accessory outlets on the device and to devices
that are plugged into a multiple-outlet strip so
that the devices are grounded through a single
line or extension cord.
Leakage current must be measured with the
ventilator powered by a conventional (grounded)
power system, even if it is normally used in an
area with isolated power. If the ventilator has a
special plug (e.g., explosion proof), a
corresponding adapter is required.
Though confirmation of grounding integrity
provides reasonable assurance of safety for
devices with permanent redundant grounding
(e.g., a bedside monitor grounded through the
line cord and its central station connection),
NFPA 99 calls for measurement of chassis
leakage current with the redundant ground intact
[NFPA 99 7-5.1.3.5]. Where practical, verify that
these devices meet appropriate chassis leakage
current requirements before installation or
connection to ground during acceptance testing.
Be alert for leakage current of the ventilator in
the off mode that is greater than about 30 A
and is greater than or equal to the leakage
current in the on mode. Although this may be
normal and proper for the ventilator, it may
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 Procedure No. 458-20010301 Critical Care Ventilators (Combined)
indicate that the on/off switch is incorrectly
wired in the neutral (instead of the hot) line.
Incorrect switch wiring poses a risk to service
personnel who believe that the power is
disconnected when the switch is off. Check the
wiring, or contact the manufacturer.
(Acceptance)
Chassis Leakage Current. Measure
chassis leakage current to ground with the
grounding conductor of plug-connected
equipment temporarily opened. Operate the
ventilator in all normal modes, including on,
standby, and off, and record the maximum
leakage current. If the ventilator has a UPS,
readings should be taken with the UPS
connected.
The measurements should be made 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, as well
as equipment plugged into a multiple-outlet strip
so that all are grounded through a single line or
extension cord. Chassis leakage current to
ground should not exceed 300 A. (Major)
Controls. [Note: This task should be
customized into specific measurement tasks for
each control function. This will create
corresponding data fields on the inspection
form.]
Verify proper operation and accuracy of
ventilation controls, which may include:
Tidal volume
Respiration rate
Inspiratory time
Expiratory time
Inspiratory:expiratory (I:E) ratio
Flow
Trigger sensitivity
100% oxygen delivery
Sigh
Manual breath
Waveshape
Verify the operation and accuarcy of ventilation
controls and indicators. These tests are typically
performed by attaching the ventilator to a lung
simulator or ventilator tester and comparing
measured values to settings on the ventilator.
Follow manufacturer recommendations for
appropriate ventilator settings at which to verify
proper operation and accuracy. Measured values
should typically be within 10% of settings.
Record the tidal volume measured by the volume
monitor at the outlet of the exhalation valve or
the PEEP valve, if used. (Volume can also be
confirmed by calculating the delivered tidal
Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
volume from the product of the test lung and
breathing circuit compliance [C] and the PIP [V =
C  PIP]. To determine the compliance, deliver a
set volume [same volume that the ventilator is
set to deliver] to the breathing circuit and test
lung with a large syringe, and record the
resultant change in pressure at the inlet of the
test lung. The compliance is the delivered
volume divided by the recorded pressure.) The
measured volume should be within 10% of the
set tidal volume.
Record the number of breaths delivered during a
1-minute period. Verify that the measured rate is
within 1 breath/min of the set respiration rate
(may be ±2 breaths/min at high set rates).
(Major, Acceptance)
Monitored Parameters and Alarms.
[Note: This task should be customized into
specific measurement tasks for each monitored
parameter and alarm. This will create
corresponding data fields on the inspection
form.]
Verify proper operation and accuracy of
monitored parameters and their associated
alarms, which may include:
Breathing rate
Inspiratory time
Peak inspiratory pressure (PIP)
Peak inspiratory flow
Positive end-expiratory pressure (PEEP)
Mean airway pressure (MAP)
Volume (both tidal and minute volume)
Fraction of inspired oxygen (FIO2); see Oxygen
Analyzer Procedure 417
Temperature of inspired air
Attach the ventilator to a lung simulator or
ventilator tester and verify that displayed values
are within 10% of simulated values.
Induce alarm conditions to activate audible and
visual alarms. Verify alarm messages on
displays. If the ventilator has an alarm-silence
feature, check the method of reset (i.e., manual
or automatic) against the manufacturer's
specifications. 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. If the ventilator is used with a
remote alarm, verify that the alarm and indicator
function properly. Alarm activation (e.g., for high
PIP, low pressure, low FIO2) should also be
within 10% of set values. (Major, Acceptance)
Preventive Maintenance
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 Procedure No. 458-20010301 Critical Care Ventilators (Combined)

Clean. Clean the exterior, interior, and

components if needed. (Major)

Calibrate. Calibrate according to the

manufacturer's instructions. (Major)

Replace. Replace components according to

the manufacturer's instructions. (Major)

Before Returning to Use

Ensure that all controls are set properly. Set
alarms loud enough to alert personnel in the
area in which the ventilator will be used. Other
controls should be in their normal pre-use
positions. If the ventilator is being used at home,
ensure that controls are set correctly before it is
returned to the patient.

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 ventilators, or equip

them with fresh batteries, if needed.

Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
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