Health Devices IPM System

INSPECTION AND PREVENTIVE MAINTENANCE

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Procedure No. 461-20010301 (Acceptance)

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Anesthesia Unit Ventilators

Used For:
Anesthesia Unit Ventilators [10-145]

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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: 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. 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.
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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.
Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
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 adjustable by
the operator and controlled by the ventilator.
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 Procedure No. 461-20010301 Anesthesia Unit Ventilators (Acceptance)
Ventilators designed solely for anesthetic
administration typically do not have
compressors.
During extended surgical 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 if not otherwise
noted)
Anesthesia systems [Evaluation], 1988 Jan;17:3.
Who should service anesthesia equipment [User
Experience Network(TM)], 1988 Feb;17:70.
Barotrauma from anesthesia ventilators
[Hazard], 1988 Nov;17:354.
Damage to plastic components from Loctite
[Hazard], 1989 Jul-Aug; 18:288.
Risk of barotrauma and/or lack of ventilation
with ventilatorless anesthesia machines
[Hazard], 1994 Jan-Feb;23:54.
Anesthesia Systems [Evaluation], 1996 May-
Jun;25:158+.
Anesthesia Systems [Evaluation update], 1998
Jan;27:4+.
Carbon monoxide exposures during inhalation
anesthesia: the interaction between halogenated
anesthetic agents and carbon dioxide absorbents
[Hazard] 1998 Nov;27:402-4.
Test Apparatus, Supplies,
Parts
Ground resistance ohmmeter
Leakage current meter or electrical safety
analyzer
Lung simulator with adjustable compliance or
ventilator tester
Pressure gauge or meter with 2 cm H2O
resolution from -20 to +120 cm H2O
Oxygen analyzer
Various breathing circuit adapters
Additional items as required for specific
manufacturers' procedures
Fresh CO2 absorbent (if procedure or
investigation results in excessive gas flows
through the carbon dioxide absorber)
Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
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 or preventive maintenance procedures
or frequencies recommended by the
manufacturer.
Manufacturers' recommended procedures for
inspection and preventive maintenance of
mechanical anesthesia ventilators vary in both
methods and required accuracy. In addition,
ventilator controls can vary greatly among
manufacturers and models. This procedure
provides the basic framework for complete
ventilator inspection and preventive
maintenance. Manufacturers' recommended
procedures should be added where appropriate.
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.
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
a shelf, ensure that it has nonslip legs or
supports.
Casters/Brakes. Verify that the correct
casters have been supplied with the ventilator
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 Procedure No. 461-20010301 Anesthesia Unit Ventilators (Acceptance)
(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 unit
across elevator thresholds and other uneven
surfaces.) Verify caster and brake operation.
AC Plug/Receptacles. 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.
AC Plug. Examine the AC power plug for
damage, if so equipped. 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.
Line Cord. Ensure that the line cord is long
enough for the ventilator's intended application;
an extension cord should not be required. (A
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.
Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
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 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. If no spare fuse is provided,
consider attaching a fuse clip and spare fuse,
particularly for high-risk devices.
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.
Tubes/Hoses. Check the condition of all
tubing and hoses. Be sure that they are not
cracked, kinked, or dirty. Check that they are
connected to the correct locations.
Cables. Inspect any cables (e.g., for sensors)
and their strain reliefs for general condition.
Carefully examine cables to detect breaks in the
insulation and to ensure that they are securely
gripped in the connectors at each end, which will
prevent rotation or other strain. Where
appropriate, verify that there are no intermittent
faults by flexing cables near each end and
looking for erratic operation or by using an
ohmmeter.
Fittings/Connectors. Verify appropriate
connectors are supplied if connection to other
hospital equipment or systems is required.
Ventilators that connect to the central piped
medical gas system should have the matching
DISS or quick-connect fitting for the appropriate
gas. Verify that suitable connectors are supplied
with the ventilator so that adapters are not
required.
Examine all gas and liquid fittings and
connectors, as well as all electrical cable
connectors, for general condition. Electrical
contacts should be straight, clean, and bright.
Gas and liquid fittings should be tight and should
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 Procedure No. 461-20010301 Anesthesia Unit Ventilators (Acceptance)
not leak. If keyed connectors are used (e.g., pin-
indexed gas connectors), ensure that no pins are
missing and that the keying is correct. Keying
pins should be securely seated in "blind" holes so
that they cannot be forced in farther.
Filters. Check the condition of gas filters, if
included in the ventilator.
Controls/Switches. Verify that software
setup parameters accessible through hidden or
service menus are correctly set for the
appropriate application and are consistent for all
ventilators. Instruction and service manuals may
contain instructions regarding such modes. If
they do not, contact the manufacturer. Discuss
appropriate settings with the department head
and users. If alarm capabilities are included, see
the Acceptance test for Alarms.
Examine all controls and switches for physical
condition, secure mounting, and correct motion.
If a control has fixed-limit stops, check for
proper alignment, as well as positive stopping.
Bellows. Check the physical condition and
proper operation of the bellows. Perform a leak
test as follows: Fill the bellows and set the
Vent/Bag valve to Bag to trap gas in the bellows.
There should be no visible deflation after one
minute.
Gas cylinders (and gauges and
regulators, if so equipped). Verify that
these are present and securely mounted. Verify
that one and only one washer is used to seal the
tank to its yoke. 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.
Breathing circuit (including filters).
Verify that these components are compatible
with the ventilator according to the
manufacturer's recommendations. Check for
leaks, the absence of obstructions, and proper
flow direction in the breathing circuit, ensuring
the proper assembly and function of fittings,
adapters, the CO2 absorber, inspiratory and
expiratory valves and PEEP valves, the APL
valve, the scavenger, and other components.
With the ventilator connected to the anesthesia
system, check for leaks in the entire system,
including the breathing circuit. This task does not
have to be duplicated if done as part of the
Anesthesia Units Procedure (Procedure 400).
Humidifier. See Heated Humidifiers
Procedure 431.
Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
Pressure-Relief Mechanism. Check the
proper operation of the pressure-relief
mechanism, if so equipped, by occluding the
breathing circuit and observing the resulting
peak pressure on the unit's pressure indicator.
Verify that pressure is vented in the breathing
circuit.
Absorber. See Anesthesia Units Procedure
400.
Fan. Check physical condition and proper
operation, if so equipped.
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. For critical care monitors and
therapeutic devices, it may be desirable to
disconnect the battery and determine if the
device 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.
Indicators/Displays. During the course
of the inspection, 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 the reading of an hour
meter, if present.
Alarms/Interlocks. 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.
Verify that alarms are loud, distinctive, and/or
bright enough to be noticed in the environment
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 Procedure No. 461-20010301 Anesthesia Unit Ventilators (Acceptance)
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.
Induce alarm conditions to activate audible and
visual alarms. Check that all associated
interlocks or features function (e.g., an infusion
pump initiates KVO rate upon alarm). If the
ventilator has an alarm-silence feature, check
the method of reset (i.e., manual or automatic)
against the manufacturer's specifications.
Labeling. Check that all necessary placards,
labels, and instruction cards are present and
legible.
Accessories. Verify that all necessary
features and accessories (e.g., transducers) have
been supplied with the ventilator. 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
instruction manual should be kept with the
ventilator and read by all operators before the
ventilator is put in use.
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
and exposed (unpainted and not anodized) metal
on the chassis of the ventilator or of the system
in which the ventilator is mounted. We
recommend a maximum of 0.5 . If the
ventilator is a component within an anesthesia
unit, grounding and leakage current
measurements can be referenced to that unit.
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 unit 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.
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 unit has
heating and cooling modes, set the thermostats
Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
so that each operates while readings are taken.
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 ventilator 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
ventilators 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 ventilators 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
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.
Modes and Settings. Anesthesia
ventilators are usually equipped only with a
control mode. However, specialized units may
have additional modes such as assist/control and
pressure support. Adjustable positive end-
expiratory pressure (PEEP) may also be
available. The function of these modes should be
inspected and verified for proper operation.
Check the operation and accuracy of ventilation
controls, which may include tidal volume, breath
rate, inspiratory time, expiratory time, I:E ratio,
pressure limit, or flow. Typically, these tests are
performed by attaching the ventilator to a lung
simulator or ventilator tester and comparing
measured values to settings on the ventilator.
The manufacturer should recommend the
Page 5 of 6
 Procedure No. 461-20010301 Anesthesia Unit Ventilators (Acceptance)

appropriate ventilator settings (e.g., tidal

volume, rate, inspiratory time, compliance) to
verify proper operation and accuracy (generally
within 10%).
Monitors and Alarms. The following
breathing circuit parameters may be monitored
by the ventilator or by the system in which the
ventilator is mounted. They should be inspected
for accuracy (generally within 10%) according to
the manufacturer's specifications:
Breathing rate
Inspiratory time
Airway pressure (e.g., PIP, PEEP, MAP, apnea)
Volume (e.g., tidal volume, minute volume,
apnea)
Fraction of inspired oxygen (FIO2; see Oxygen
Analyzers Procedure 417)
Alarm settings (e.g., high PIP, low MAP, low
pressure, low FIO2) should be tested for proper
and accurate activation.
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.
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.
Change absorbent in CO2 absorber (if procedure
or investigation results in excessive gas flows
through the carbon dioxide absorber).

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