Health Devices IPM System

INSPECTION AND PREVENTIVE MAINTENANCE

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Procedure No. 400-20010301 (Acceptance)

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Anesthesia Units
Used For:
Anesthesia Units [10-134]

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Also Called: Anesthesia machines, anesthesia workstations

Commonly Used In: Operating rooms (ORs), emergency departments, trauma rooms, delivery
rooms, any areas where anesthetic agents are used

Scope: Applies to anesthesia units; includes leak testing of vaporizers and should be used in
conjunction with Anesthesia Unit Vaporizers Procedure 436 (in the very rare case where an
anesthesia unit may still use flammable anesthetic agents, refer to Conductive Furniture and Floors
Procedure/Form 441); does not apply to oxygen monitors with an alarm, spirometers, other
monitors, or ventilators that might be part of the breathing system (see Anesthesia Unit Ventilators
Procedure 461)

Risk Level: High

Type Interval Time Required

Major 6 months _____ hours

Minor Not Applicable
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Overview
Improperly modified or inadequately maintained
Most surgical procedures are performed while anesthesia units have injured patients and
the patient is under general anesthesia. Usually, hospital personnel, sometimes fatally. Gas leaks
the patient is anesthetized by a narcotic or can adversely affect the accuracy of gas delivery
barbiturate injection followed by administration to the patient, as well as add anesthetic agents
of an inspired gas mixture of oxygen, nitrous to the OR atmosphere. Trace levels of
oxide, and the vapor of a volatile liquid anesthetics have been implicated as a health
anesthetic, typically a halogenated hydrocarbon. hazard to chronically exposed OR personnel and
The anesthesia unit administers this mixture of their unborn children. Inadvertent switching of
anesthetic gases and life-sustaining oxygen, gas supplies, failure of an alarm to respond to an
varying the proportions to control the patient's excessively low oxygen pressure, and
level of consciousness. If respiratory assist is misconnected or improperly calibrated
necessary (e.g., in cases of muscular blockade), flowmeters have also caused anesthesia-related
a ventilator may be connected to the patient accidents.
breathing system to force the gas mixture into
the patient's lungs. Because mishandling and mistakes can have
severe consequences, life-support devices such
as anesthesia units should be operated and
Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
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 Procedure No. 400-20010301 Anesthesia Units (Acceptance)

inspected only by qualified personnel who have a and other gases at high pressure (see Table 1)
thorough knowledge of the units and their are connected to the high-pressure system of the
functions. If you are unsure of any aspect of the anesthesia unit by yoke fittings that comply with
procedure, consult the manufacturer before the Compressed Gas Association (CGA) pin-index
inspecting an anesthesia unit. safety system (see Figure 1). Unique placements
of pins and mating holes on the pin-index fittings
The anesthesia unit consists of four systems: the prevent connection of a gas cylinder to the
gas supply system, the gas control, the wrong inlet. Inside the unit, each high-pressure
vaporizers, and the breathing system. gas flows through a filter, a check valve (for one-
way flow), and a regulator that reduces the
Gas Supply. This system delivers a variety of pressure to approximately 45 psi.
gases to the patient. Cylinders containing oxygen

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Because oxygen and nitrous oxide are used in

relatively large quantities, they are usually
drawn from the hospital's central gas supplies,
which are more convenient and economical than
compressed-gas cylinders. However, 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.

Centrally supplied gases are delivered directly to

the intermediate-pressure gas control system at
approximately 50 psi through low-pressure hoses
and connectors. These connectors may not Gas Index Pins CGA Connector
comply with a universal standard safety system, Number
but each is designed to prevent mismating the Oxygen 2-5 870
gas supply and the unit inlet. Nitrous Oxide 3-5 910
O2 - CO2 (CO2<7%) 2-6 880
Some anesthesia units may provide an oxygen O2 - CO2 (CO2 >7%) 1-6 940
power outlet to drive auxiliary devices (e.g., a O2 - He (He>80%) 4-6 930
ventilator). O2 - He (He<80%) 2-4 890
Air 1-5 950

Figure 1. Pin-index safety system

Gas Control. This system regulates gas flow

rates so that the gases can be mixed and
delivered under accurate, constantly metered
control. The operator must be able to adjust the

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 Procedure No. 400-20010301 Anesthesia Units (Acceptance)

ratios or make rapid gross changes in flow rates

without inducing system interactions that cause A heated-blender vaporizer is used only for
temporary delivery of undesirable mixtures. desflurane. It requires electrical power to heat
the agent to a thermostatically controlled 39C,
The flow of each gas is controlled by a valve and producing a stable, saturated vapor pressure of
indicated by a glass-tube flowmeter. After gases 1,500 mm Hg. No wick is used, and no carrier
pass the control valve and enter the low- gas enters the sump chamber. Instead, a stream
pressure system, they can be administered to of vapor under pressure flows out of the sump;
the patient. this stream blends with the background gas
stream, which originates from the anesthesia
A fail-safe provision in many anesthesia units unit's flowmeters, to achieve the desired
protects the patient against a fall in pressure of concentration.
life-sustaining oxygen. If the oxygen pressure
drops below about 25 to 30 psi, some units shut (Desflurane, a volatile inhalation anesthetic
off the flow of all other gases, while others marketed by Ohmeda Pharmaceutical Products
reduce all gas flow rates in proportion to the Division under the trade name Suprane, and
drop in oxygen pressure. Newer anesthesia units sevoflurane, marketed by Abbott under the trade
have additional safety systems that provide a name Ultane, have characteristics that differ
minimum percentage of oxygen (between 21% markedly from anesthetics currently in use
and 30%) and/or deliver a minimum flow of enflurane, halothane, and isoflurane. For
oxygen (usually 150 to 250 mL/min) (see the example, their low solubilities allow rapid
Minimum Oxygen Flow and Percentage task). induction of and emergence from anesthesia.
Thus, by increasing the speed of recovery,
Vaporizers. These devices add the vapor of a desflurane and sevoflurane have the potential to
volatile liquid anesthetic (e.g., halothane, shorten hospital stays, although this has not yet
isoflurane, enflurane) to the gas mixture, when been consistently demonstrated.)
desired, and aid in controlling the vapor
concentration. Breathing System. Although it is designed
primarily for sustained, efficient gas delivery to
According to the American Society for Testing the patient, the breathing system may also
and Materials (ASTM) standard ASTM F1161-88, remove carbon dioxide and provide mechanical
anesthetic agent vaporizers are required to be or manual ventilation of a patient who cannot
concentration calibrated (i.e., a calibrated knob breathe spontaneously, as well as positive end-
controls the output concentration). Older expiratory pressure (PEEP), if required. The
vaporizers, such as the Copper Kettle and the breathing system typically includes a scavenging
Vernitrol, do not have a single control for system to remove waste gases.
selecting the concentration of anesthetic vapor.
Where possible, these units should be removed Two types of breathing systems are used to
from service. Contemporary concentration- deliver the anesthetic mixture from the unit to
calibrated vaporizers are of two types: variable the patient, although they may assume a variety
bypass and heated blender. of configurations.

The variable-bypass (conventional) vaporizer is The T-piece or open system may be a

used for most volatile agents (e.g., halothane, nonrebreathing system consisting of a reservoir
isoflurane, enflurane, sevoflurane). The total bag and a gas-delivery hose connected through a
background gas flow that enters the unit is split nonrebreathing (one-way) valve to the face
into two streams. The smaller stream, which acts mask or endotracheal tube. The patient breathes
as the carrier gas, passes through the vaporizing the anesthetic mixture directly from the unit, and
chamber containing the anesthetic agent and exhaled gas is vented out of the system. T-piece
becomes saturated with agent vapor; the systems that do not include the nonrebreathing
remainder of the gas bypasses this chamber. A valve may allow partial rebreathing, depending
wick may be used in the vaporizing chamber to on the inflow of fresh gas.
provide increased surface area for efficient
evaporation of the drug and saturation of the The circle or closed system is a continuous loop
carrier gas. The saturated carrier gas leaves the in which check valves allow gas to flow in only
chamber and mixes with the bypass gas. One one direction. The patient inhales from and
adjustment is made to set the desired exhales into the system. Fresh gases from the
concentration. This adjustment simultaneously anesthesia unit enter at one point, mix with
balances the carrier and bypass flows to produce previously exhaled gases, and pass to the
the blend required for the set concentration. The patient, who inhales the mixture. Newly exhaled
mixture exits the vaporizer and is delivered from gases are channeled to a carbon dioxide
the anesthesia unit as the fresh gas to be absorber, which removes almost all the carbon
inspired by the patient. dioxide produced by body metabolism and routes

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 Procedure No. 400-20010301 Anesthesia Units (Acceptance)

the scrubbed gases back toward the patient. En Monitoring and anesthesia systems: integration
route, the scrubbed gases become mixed with and a new option. 1991 Mar-Apr;20:131-2.
fresh gases. Use of inadequate (old) anesthesia scavenger
interfaces [Hazard], 1993 Dec;22:592.
A scavenging system should be included to Anesthesia systems [Evaluation], 1996 May-
remove waste gas from the vent port of a T- Jun;25:158-211.
piece breathing system or from the adjustable Anesthesia systems [Evaluation], 1998 Jan;27:4-
pressure-limiting (APL) valve and relief valve of a 27.
ventilator of a circle system to reduce the Carbon monoxide exposures during inhalation
quantity of gas that escapes into the OR. Such a anesthesia: the interaction between halogenated
scavenging system is necessary because trace anesthetic agents and carbon dioxide absorbents
levels of anesthetics are believed to cause an [Hazard], 1998 Nov;27:402-4.
increased incidence of spontaneous abortion,
congenital anomalies in offspring, and neoplastic
disease and may affect the mental and physical
Test Apparatus, Supplies,
abilities of exposed personnel. The breathing Parts
system should be checked before each use for
leaking gases. The concentration of waste Pressure gauge or meter, -10 to +80 cm H2O
anesthetic gas should also be routinely surveyed; (accuracy 2 cm H2O at 30 cm H2O)
the facility's environmental survey program must
document the survey interval, which should be
Gas-specific flowmeters or air flowmeters with
based on past findings. The scavenging system
ranges of approximately 0.1 to 1.0 L/min
must include pressure-relief mechanisms so that
and 1 to 20 L/min, 2% accuracy, and one
abnormal pressures cannot develop in the
flowmeter for 10 to 100 L/min (10% of
scavenging system and interfere with operation
reading)
of the breathing system.
Gas correlation table(s) (to correct flow
Anesthesia units either come with physiological
measurements of gases and gas mixtures
monitors integrated into the unit or provide
other than air made with air flowmeters)
shelving to support such monitors. Most also
provide mounting for a suction regulator and
Spirometer
canister and other accessories, along with
storage for drugs, supplies, and related items.
Stopwatch or watch with a second hand

Test lung bag or lung simulator

Breathing/reservoir bag (adult)

Sphygmomanometer bulb with tubing and

Citations adapter
(from Health Devices if not otherwise
noted) Tubing and adapters for connecting the test
devices to the anesthesia unit
Anesthesia units with a flowmeter-controlled
vaporizer [Hazard], 1986 Dec;15:336-7. Cylinder of each type of gas used with the unit
Vaporizer leak with Mapleson breathing systems being inspected; cylinders should have a
[Hazard], 1986 Dec;15:344-5. minimum pressure of 745 psi for nitrous
Concentration calibrated vaporizers [Hazard], oxide and 1,000 psi for oxygen
1987 Mar-Apr;16:112-3.
Pre-use testing prevents "helpful" reconstruction Disposable corrugated breathing hose
of anesthesia components [Hazard], 1987
May;16:178-9. Leak-detecting solution
Anesthesia systems [Evaluation], 1988 Jan;17:3-
34. Conductive lubricant for conductive casters
Who should service anesthesia equipment? [User
Experience Network], 1988 Feb;17:70-1. Trichloroethylene cleaning solvent or solvent
Pre-use anesthesia check fails to find faults recommended by the manufacturer (be sure
[Hazard], 1988 Sep;17:274-6. (Contains pre-use to review the manufacturer's Material Safety
checklist for anesthesia units.) Data Sheet)
Anesthesia systems [Evaluation update], 1988
Dec;17:366-7. Lubricant as specified by manufacturer
Anesthesia units and breathing systems
[Standard], 1989 Oct;18:363.

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 Procedure No. 400-20010301 Anesthesia Units (Acceptance)

Fresh CO2 absorbent (if procedure or Check that the anesthesia unit is suitably
investigation results in excessive gas flow constructed to withstand normal hospital use and
through the carbon dioxide absorber) 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
Special Precautions be recognized during prepurchase evaluation.
However, if any are evident, discuss corrective
ECRI is aware of a number of incidents in which action with the manufacturer. If not correctable,
improperly serviced ventilation or anesthesia warn users or take other preventive measures.)
equipment was implicated in patient injury or
death. Do not perform any procedures, Examine the exterior of the anesthesia unit for
adjustments, repairs, or modifications unless you cleanliness and general physical condition.
thoroughly understand the unit and have verified Ensure that plastic housings are intact, that all
the appropriateness of the intended actions. assembly hardware (e.g., screws, fasteners) is
Resolve any questions or uncertainties with the present and tight.
manufacturer, the anesthetist, or ECRI before
placing a unit into use. Carbon Dioxide Absorber. Check the
carbon dioxide absorber housing for general
To avoid the adverse effects of exposure to
physical condition. Verify proper operation of the
anesthetic gases, all testing should be done with
elevating mechanism and clamps. Remove the
an operating scavenging system in place or an
canister from its holder, without inverting it, and
alternative means to vent excess gases from the
check the gaskets.
vicinity of inspecting personnel. If a flammable
anesthetic is used, be sure all traces of the gas
are cleared away before performing any Labeling. Check that all necessary placards,
electrical tests. Check that all valves, including labels, conversion charts, and instruction cards
the gas cylinder valves, are turned off at the are present and legible. Check for proper color-
beginning of the inspection. Turn all valves off coding for corresponding parts (e.g., green for
again when the inspection is complete. oxygen, blue for nitrous oxide).

When testing cyclopropane flowmeters, observe Mount. Ensure that the assembly and weight
noted procedures to avoid a buildup of explosive distribution is stable and that the anesthesia unit
levels of cyclopropane. will not tip over when pushed or when a caster is
jammed on an obstacle (e.g., line cord,
When cleaning parts of the anesthesia unit with threshold), as may occur during transport.
any organic solvent, allow time for the solvent to
evaporate. When the parts appear dry, take the If the anesthesia unit has a heating element,
added precaution of briefly flushing them with a keep hoses, wires, and cables away from the unit
high oxygen flow rate. and place the unit so that patients and staff are
protected against contact with hot surfaces.

Check any shelves, brackets, or supporting

Procedure structures. Check the security of the
attachments.
Before beginning an inspection, carefully read
this procedure and the manufacturer's
instruction and service manuals; be sure that
Casters/Brakes. Verify that the correct
casters have been supplied with the anesthesia
you understand how to operate the equipment,
unit (e.g., size, correct swivel). (ECRI
the significance of each control and indicator, and
recommends 5 in [12.7 cm] diameter casters for
the alarm capabilities. Also review special
mobile devices to reduce shock to the unit and to
inspection and preventive maintenance
minimize the effort required to roll the unit
procedures recommended by the manufacturer.
across elevator thresholds and other uneven
surfaces.) Verify caster and brake operation.
Check that gas hoses do not lie on the floor or
Qualitative Tasks loop near the casters.

Chassis/Housing. Check for shipping AC Plug/Receptacles. A solidly

damage; report any damage to the constructed, good quality plug with adequate
manufacturer, shipper, or service organization, strain relief is acceptable, but the use of a
and arrange for repair or replacement. Hospital Grade plug (identifiable by a green dot
and/or labeling) will eliminate guesswork and
ensure a plug of acceptable construction quality.

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 Procedure No. 400-20010301 Anesthesia Units (Acceptance)

Right-angle plugs are unacceptable for devices are the proper current rating and type. If the
that are moved frequently. A good quality two- value and type are not labeled, check the manual
prong plug is acceptable for double-insulated for the proper current rating and type and
devices. Replace the plug or have the supplier permanently mark this information on the
replace it if it is not Hospital Grade or otherwise anesthesia unit housing near the fuse holder. If
suitable. Hospital Grade molded plugs are no spare fuse is provided, attach a fuse clip and
acceptable. spare fuse.

Examine the AC power plug for damage. Attempt Verify that accessory outlets have independent
to wiggle the blades to determine if they are overcurrent protection (fuse or circuit breaker)
secure. Shake nonmolded plugs and listen for so that a short in a device plugged into the
rattles that could indicate loose screws. accessory outlet or an accessory overload will
not disable the anesthesia unit. If this is not
If the anesthesia unit has electrical accessory available, then consider labeling the primary
outlets, inspect them for damage and insert an device to clearly indicate where the unit's fuse or
AC plug into each to check that it is held firmly. circuit breaker is located, and/or install a fused
If the outlets are used for critical devices or Hospital Grade (or similar quality) plug on any
devices are plugged and unplugged frequently, commonly used accessories that are not already
consider more extensive testing. Use a tension provided with suitable overcurrent protection.
tester to measure the tension of each contact.
With the anesthesia unit plugged in, use an Tubes/Hoses. Check the condition of all
outlet test fixture to verify that the accessory tubing and hoses. Check that they are correctly
outlet is energized and correctly wired. See connected and positioned so they will not kink,
Electrical Receptacles Procedure/Form 437 for interfere with the operator, or be damaged
more information. during operation. Verify that color-coded hoses
are the correct color for the gas that the hose
Line Cord. Ensure that the line cord is long carries.
enough for the unit's intended application; an
extension cord should not be required. (A length Cables. Inspect the cables (e.g., sensor,
of 10 ft [3 m] is suitable for most applications, electrode) and their strain reliefs for general
although 18 ft [5.5 m] has been suggested for condition. Examine cables carefully to detect
OR equipment.) breaks in the insulation and to ensure that they
are gripped securely in the connectors of each
The cord should be of suitable quality and end to prevent rotation or other strain. Where
current-carrying capacity. Hard Service (SO, ST, appropriate, verify that there are no intermittent
or STO), Junior Hard Service (SJO, SJT, or SJTO), faults by flexing electrical cables near each end
or an equivalent-quality cord should be used. and looking for erratic operation or by using an
ohmmeter.
Verify that the anesthesia unit has adequate
protection against power loss (e.g., from Fittings/Connectors. Verify appropriate
accidental disconnection of a detachable power
connectors are supplied. Devices that connect to
cord, disconnection of the power cord from the
the central piped medical gas system should
wall, or depleted battery if a battery-powered
have the matching DISS or quick-connect fitting
device is not plugged in). Equipment having a
for the appropriate gas. Verify that suitable
detachable power cord should also have
connectors are supplied with the anesthesia unit
adequate capture devices, cleats, or channels to
so that adapters are not required.
hold the cord in place. If these are absent,
request that the supplier provide suitable means
Examine all gas and liquid fittings and
of securing the cord. Verify that the anesthesia
connectors, as well as all electrical cable
unit has adequate alarms or indicators for line-
connectors and sockets, for general condition.
power loss and battery depletion and an
Electrical contacts should be straight, clean, and
adequate battery-charging indicator. Also check
bright. Gas and liquid fittings should be tight and
line cords of battery chargers.
should not leak. If keyed connectors are used
(e.g., pin-indexed gas connectors), ensure that
Strain Reliefs. Examine the strain reliefs at no pins are missing and that the keying is
both ends of the line cord. Be sure that they hold correct. Keying pins should be securely seated in
the cord securely. "blind" holes so that they cannot be forced in
farther. Check the yoke clamping screw, and
Circuit Breaker/Fuse. If the anesthesia make sure empty yokes have plugs.
unit has a switch-type circuit breaker, check that
it moves freely. If the anesthesia unit is Filters. Check the presence and condition of
protected by an external fuse, verify that the all compressed-gas filters.
fuse type is labeled and that all fuses and spares

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 Procedure No. 400-20010301 Anesthesia Units (Acceptance)

condition of the battery charger, and verify that

Controls/Switches. Verify that software battery charge indicators function. Provide users
setup parameters accessible through hidden or with instructions and/or checklist procedure to
service menus are correctly set for the ensure adequate battery charging and
appropriate application and are consistent for all performance.
anesthesia units. Instruction and service
manuals may contain instructions regarding such Alarms/Interlocks. Verify that
modes. If they do not, contact the manufacturer. configurable alarm features are appropriately set
Discuss appropriate settings with the department and consistent among all anesthesia units. It
head and users. If alarm capabilities are should not be possible for critical alarms to be
included, see the Acceptance test for Alarms. turned off, silenced, or defeated without
adequate warning to the operator or automatic
Examine all controls and switches for physical alarm reactivation after a short delay. Such
condition, secure mounting, and correct motion. deficiencies should usually be recognized during
If a control has fixed-limit stops, check for prepurchase evaluation. However, if any are
proper alignment, as well as positive stopping. If found, review the justification for purchasing this
a control has fixed-limit stops, check for proper anesthesia unit and discuss corrective action
alignment, as well as positive stopping. with the manufacturer. (Alarm features may be
optional or programmable.) If no remedy is
Check that the concentration dial on each available, a user training program should be
vaporizer moves freely and that only one instituted to reduce the risk of incorrect use. A
vaporizer can be on at a time. warning label on the anesthesia unit or a poster
in the area of use may be appropriate.
Indicators/Displays. Confirm the
operation of all lights, indicators, meters, Verify that alarms are loud, distinctive, and/or
gauges, and visual displays on the anesthesia bright enough to be noticed in the environment
unit and charger, if so equipped. Be sure that all in which the anesthesia unit will normally be
segments of a digital display function. used. If a remote alarm-indicator is required,
verify that it is available and functioning. Audible
Flowmeters. Examine each flowmeter for alarm-volume controls should not allow the
alarm to be turned off or lowered to an
general physical condition. Observe the float
indiscernible volume.
motion as its associated flow control valve is
turned on. The valve should turn smoothly with
Induce alarm conditions to activate audible and
only slight drag, and the float should rise and fall
visual alarms. Check that all associated
freely as the flow is raised or lowered. At
interlocks or features function (particularly the
maximum flow, the float should still be visible at
vaporizer interlocks, which should allow
the top of the flow tube. Each valve (except O2)
activation of only one vaporizer at a time). If the
should have a definite shutoff position at which anesthesia unit has an alarm-silence feature,
the float should be motionless at its zero level. check the method of reset (i.e., manual or
Check for free play in the control valve by automatic) against the manufacturer's
pushing, pulling, and gently rocking the stem specifications.
from side to side without rotation. The stem
should feel firm, and the flowmeter float should
not move. The control valve knob should require
Audible Signals. Operate the unit in such a
way as to activate all audible signals, such as
turning through at least 90 to change the flow
advisory or cautionary tones. Confirm
rate from 10% to 100% of full scale.
appropriate volume, as well as the operation of a
volume control, if so equipped. Check that the
Battery/Charger. Determine the audible signals are appropriate for the test
replacement interval for all batteries and conditions used and that they can be easily
document the interval(s) in an equipment control heard in the area on which the anesthesia unit
system or a hard copy file for the anesthesia will be used.
unit. Be sure to include batteries/cells for clocks
and/or memory logs. Disconnect the battery and
Fail-Safe Oxygen Valves. Close all
determine if the anesthesia unit still operates on
control valves. Open all cylinder stem valves and
line power. Check the battery-operated power-
external gas source valves. Connect the gas
loss alarms on AC and pneumatic devices, if so
scavenging or other evacuation system to a
equipped.
common gas outlet. Turn on the main gas
control, and open the flow control valves until
Operate the anesthesia unit on battery power for
the flowmeter for each gas reads midscale. Then
several minutes to verify that the battery is
disconnect or turn off all oxygen sources. The
charged and can hold a charge. Activate the
flow of other gases should fall proportionately as
battery test function, if so equipped. Check the
the oxygen flow decreases such that the oxygen

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 Procedure No. 400-20010301 Anesthesia Units (Acceptance)

flow is always greater than the flow of the other transmitted to other parts of the unit where they
gases. All gas flow should cease when the could affect the accuracy of gas delivery and the
oxygen flow reaches zero; however, air may be concentration of anesthetic gases.
an exception. (Flow of cyclopropane normally
falls more slowly than other gases.) To test this check valve, attach the -10 to +80
cm H2O pressure gauge or meter to the common
In addition to the automatic shutoff or reduction gas outlet. Turn off all vaporizers. Adjust the
of gas flow, audible or visual alarms signifying oxygen flow control valve to maintain an outlet
low oxygen pressure should have been activated, pressure of 30 cm H2O. Turn on the vaporizer,
if the anesthesia unit is so equipped. Silence the
and readjust, if necessary, to maintain 30 cm
alarm by raising the oxygen pressure above the
H2O. Carefully open the vaporizer filler cap (to
preset alarm limit. If the unit has an alarm that
does not respond, check for exhausted batteries prevent a sudden flow of oxygen into the
or another source of the malfunction. vaporizer), and observe the outlet gauge
pressure. A sudden pressure drop suggests a
leaky check valve. If the check valve is missing
Directional Valves. Check the general or defective, contact the manufacturer for
physical condition of the inspiratory and
replacement. Note: This method may not be
expiratory valve disks and be sure that they fit
possible on newer units that always maintain a
smoothly against the valve seats. The valve disks
minimum flow of oxygen. On such devices, follow
should flutter up and down and should not stick
the manufacturer's instructions for testing the
to their seats.
common outlet back-pressure check valve.
Connect a disposable breathing circuit to the
inspiratory and expiratory ports of the absorber Accessories. Verify that all necessary
manifold. Attach an adult reservoir bag to the features and accessories (e.g.,
unit's bag mount and the test lung bag at the sphygmomanometers, ventilators, vaporizers,
wye (or elbow) piece of the breathing circuit. respiratory gas monitors) have been supplied
With the APL valve closed, increase the O2 flow with the anesthesia unit. Inspect these
accessories separately using the appropriate
to 2 L/min and allow the reservoir bag to fill;
inspection procedures, and record on separate
then reduce the flow to its minimum. Repeatedly
forms. At least one copy each (two are generally
squeeze the bag to ventilate the test lung while
preferred) of the instruction and service
observing the action of the inspiratory and
manuals, including schematics, should be
expiratory valves.
shipped with the anesthesia unit and filed in the
central equipment file. A copy of the instruction
Remove the breathing hose from the expiratory
manual should be kept with the unit and read by
port and cap both the port and the end of the
all operators before the device is put in use.
hose. With the test lung bag inflated, turn off the
unit to stop gas flow; then squeeze (or
compress) the lung. The gauge on the absorber
should not fluctuate. If substantial pressure Quantitative Tasks
fluctuation is observed, or if the test lung bag
gradually empties, the inspiratory valve is Grounding Resistance. Use an
permitting reverse flow and should be replaced ohmmeter, electrical safety analyzer, or
by the manufacturer. Disconnect the breathing multimeter to measure and record the resistance
circuit from the unit, cap the expiratory port, and between the grounding pin of the power cord
cap the inspiratory port. Connect the -10 to +80 and exposed (unpainted and not anodized) metal
cm H2O gauge to the expiratory port. Turn on on the chassis. The grounding resistance should
the unit and fill the reservoir bag. Then, turn off not exceed 0.5 .
the unit and squeeze the reservoir bag to
produce increased pressure fluctuations in the If the device has an accessory outlet, check its
absorber while monitoring for pressure changes grounding to the main power cord.
at the expiratory port. If substantial pressure
changes can be measured at the expiratory port, Chassis Leakage Current. Note: Some
the valve is permitting reverse flow and should devices (especially devices incorporating a
be replaced by the manufacturer. microprocessor, motor, or compressor) may be
damaged by switching polarity while the device
Common Outlet Back-Pressure is on. If you perform reverse polarity testing,
Check Valve. Most anesthesia units turn off the anesthesia unit until the motor stops
manufactured after 1968 with mounted bubble- or for at least 10 sec before switching polarity.
through vaporizers have a check valve in the gas Although reversed polarity testing is not
delivery system to prevent pressures at the required, it may be advisable on an anesthesia
outlet (e.g., produced by a ventilator) from being unit of questionable quality.

Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
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 Procedure No. 400-20010301 Anesthesia Units (Acceptance)

Safety for further details and a discussion of the

With the polarity of the power line normal and use of these devices in hospitals.)
the equipment ground wire disconnected,
measure chassis leakage current with the Oxygen Flush Valve. Attach the 100
anesthesia unit operating in all normal modes, L/min flowmeter to the common outlet. Set the
including on, standby, and off. Record the oxygen flow rate to a 2 L/min indication on the
maximum leakage current; it should not exceed unit's oxygen flowmeter, and actuate the oxygen
300 A for patient-care equipment [NFPA 99 7- flush control. The rate should rise to between 35
5.1.3.5(a)]. ECRI does not recommend chassis and 75 L/min. The unit flowmeter indication
leakage current tests of double-insulated should remain near 2 L/min unless the
devices. manufacturer's specifications state otherwise. If
it falls more than 1 L/min, check for an
The measurements should be made with all inadequate oxygen supply or a partially occluded
accessories that are normally powered from the oxygen line in the unit. If the problem cannot be
same line cord connected and turned on. This corrected, contact the manufacturer for a
applies to devices that are plugged into replacement.
accessory outlets on the anesthesia unit and to
devices that are plugged into a multiple-outlet Cycle the flush control slowly several times; it
strip so that the devices are grounded through a should move smoothly and not have a tendency
single line or extension cord. to stick. Check that the oxygen flow returns to 2
L/min within 2 sec each time the flush valve is
Leakage current must be measured with the closed.
anesthesia unit powered by a conventional
(grounded) power system, even if it is normally High-Pressure Leaks. Close all flow
used in an area with isolated power. If the control valves on the unit that can be closed.
anesthesia unit has a special plug (e.g., Disconnect the unit from the piped gas system.
explosion proof), a corresponding adapter is Open all cylinder valves one full turn, noting any
required. motion of the flowmeter floats. Float movement
with a closed valve indicates a leaky flowmeter
Though confirmation of grounding integrity valve. Record the unit's pressure gauge readings,
provides reasonable assurance of safety for verifying that they are close to the service
devices with permanent redundant grounding, pressure values listed in Table 1. Close the
NFPA 99 calls for measurement of chassis cylinder valves. The pressure drop over 30 sec
leakage current with the redundant ground intact should be negligible. Excess pressure drop
[NFPA 99 7-5.1.3.5]. Where practical, verify that indicates an unacceptable leak. Contact the
these devices meet appropriate chassis leakage manufacturer for repair or replacement.
current requirements before installation or
connection to ground during acceptance testing. With the unit off and all pressure gauges at zero,
open the O2 and N2O cylinders to pressurize the
Be alert for leakage current of the anesthesia
gauges, then close the cylinder valves. After
unit in the off mode that is greater than about 30
verifying that the O2 pressure does not fall, fully
A and is greater than or equal to the leakage
current in the on mode. Although this may be open the N2O flow control valve and turn on the
normal and proper for the anesthesia unit, it gas machine. The N2O pressure gauge should
may indicate that the on/off switch is incorrectly drop slightly but then stabilize. If the pressure
wired in the neutral (instead of the hot) line. reading on either gauge continues to fall, an
Incorrect switch wiring poses a risk to service unacceptable leak is present and the
personnel who believe that the power is manufacturer should be contacted.
disconnected when the switch is off. Check the
wiring, or contact the manufacturer. Intermediate Pressure Leaks.
Connect the hoses to the external pipeline gas
Inspect AC adapters used to power (or recharge) source, and test the supply line hoses with leak-
certain devices for CE mark or UL (or other detecting solution. If leaks are identified that
testing laboratory) listing and to verify that it is cannot be eliminated by tightening the fittings,
labeled to identify the device with which it is to contact the manufacturer for repair or
be used. ECRI recommends testing of adapters, replacement.
particularly those that are not listed, by
measuring the leakage current from each
secondary (low voltage) connection to ground.
Low-Pressure Leaks. With the unit off
The leakage current should not exceed the limits and vaporizer and flow control valves open,
for the device chassis leakage current to ground attach the -10 to +80 cm H2O pressure gauge to
(300 A in patient-care areas). (See Electrical the unit's common gas outlet using a three-way
connector, and air pressurize the outlet to 30 cm

Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
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 Procedure No. 400-20010301 Anesthesia Units (Acceptance)

H2O with a sphygmomanometer squeeze bulb. If N2O meter can be indirectly tested by measuring
the pressure falls below 25 cm H2O in 30 sec, the accuracy of a known mixture of O2 and N2O.
the leakage rate is excessive. Contact the For example, if a 1:1 mixture is delivered, the
manufacturer for repair or replacement. total flow should be the sum of the flow for each
meter when measured using a flowmeter
Breathing System. Turn the anesthesia correlation table for 1:1 N2O:O2, when the O2
unit off, and connect the -10 to +80 cm H 2O flowmeter is accurate.
pressure gauge to a piece of breathing hose that
connects the inspiratory port to the expiratory The following procedure applies to each
port. Close the APL valve. In place of the flowmeter on the anesthesia unit. Connect the 1
reservoir bag, insert a one-hole stopper with a to 20 L/min flowmeter to the common gas outlet,
fitting for the sphygmomanometer squeeze bulb. with its discharge directed into the scavenging or
Use the bulb to pressurize the breathing system other gas evacuation system. Starting with
to 50 cm H2O. If the pressure falls below 30 cm oxygen, then for each gas in turn, set the flow
rate at the highest and 1 L/min settings for each
H2O within 30 sec, there is a leak in the
of the unit's flowmeters. Record the setting
breathing system that should be corrected. versus the reading of the test flowmeter.
Contact the manufacturer for repair or
replacement. During this test, verify the The readings on the unit's flowmeters should
accuracy of the breathing system pressure gauge agree with those of the test flowmeter to within
by comparing its readings with those of the test 10% of set values or 20% when operating two
pressure gauge. flowmeters together (e.g., O2 and N2O). If the
error is excessive, contact the manufacturer for
APL Valve. Leave the setup as in the repair or replacement.
previous task, but replace the breathing bag,
and restore the original pressure-limiting valve
setting.
Minimum Oxygen Flow and
Percentage. Close, as far as possible, the
Turn on the unit and fill and squeeze the bag to valve to the anesthesia unit's oxygen flowmeter.
verify that the valve holds pressure until the set Connect the 0.1 to 1.0 L/min flowmeter to the
pressure is exceeded and that it then opens. common gas outlet. The test flowmeter should
Check that the opening pressure is adjustable indicate the minimum flow specified by the
from approximately 1 to at least 30 cm H2O. manufacturer (usually 100 to 250 mL/min).
Remove the flowmeter and, in its place, attach
Other valves, such as the Georgia and Drager
an O2 monitor. Set the flow of oxygen to around
valves, may operate in a different manner and at
a higher pressure and should be tested according 200 mL/min. Starting with the flow of nitrous
to manufacturer procedure and specifications. oxide off, gradually increase the flow of N2O.
Verify that at least the minimum percentage of
Scavenging System. Connect the oxygen (specified by the manufacturer) is
pressure gauge between the APL valve exhaust delivered as the flow of nitrous oxide is
port and the scavenging system intake hose. increased. Gas from the common gas outlet
Leave the setup as in the previous test, with the should be scavenged.
APL valve closed. With the scavenging system
operating at maximum suction, the pressure PEEP Valve. Using a disposable breathing
gauge reading should be between -0.5 and 0 cm circuit and a test lung bag or lung simulator, use
H2O. Fully open the APL valve, and set a 10 the -10 to +80 cm H2O pressure gauge to
L/min oxygen flow rate. With the scavenging measure the airway pressure at the test lung bag
system at the minimum vacuum, the gauge or lung simulator. The gauge can be connected at
reading should not exceed 2 cm H2O. the Luer connector on the patient elbow or wye
of the circuit. Manually ventilate the test lung
Repeat the last measurement with the APL valve bag with the PEEP valve set at 0 cm H2O water
fully open while occluding the APL valve outlet pressure. The end-exhalation pressure in the
and activating the flush valve for 5 sec. The breathing system should be less than 1 cm H2O
pressure should remain 10 cm H2O. at a fresh gas flow of 4 L/min and APL valve
setting of 30 cm H2O.
Flowmeters. In most cases, N2O cannot be
measured independently because of hypoxic If the PEEP valve is calibrated, set it to deliver 5
mixture safety features. Correlation tables for cm H2O water pressure. The pressure in the
gas mixtures (e.g., 1:1 N2O:O2) can be obtained breathing system at the end of exhalation should
from the air flowmeter manufacturer. Once the be within 1.5 cm H2O of the set value. Repeat
accuracy of the O2 flowmeter is determined, the the test with the PEEP valve set at 10 cm H2O.

Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
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 Procedure No. 400-20010301 Anesthesia Units (Acceptance)

delivering another breath. The displayed tidal

Exhaled Volume Monitor. Many units volume should be within 15% of the set value of
are equipped with integral monitors that the test lung. Next, deliver six breaths in a 1 min
measure and display the volume of gas that is period. The minute volume display of the unit
exhaled by the patient. These anesthesia units should be 3 L (3,000 mL) 15%. An apnea
generally can display tidal volume, minute alarm should occur when breaths are not
volume, and respiration rate. delivered.

To test the function of the monitor, connect the

inspiratory side of the breathing circuit to the Before Returning to Use
unit. If necessary, attach the monitor's flow
sensor at the expiratory port, making sure that it Depressurize external gas supply; return all
is oriented to measure flow into the expiratory flowmeters to zero position; turn all vaporizers to
port. Connect the spirometer between the off position; and reconnect all tubing (e.g., main
expiratory port and expiratory limb of the circuit. common gas outlet tubing). Return all controls to
Then connect the test lung bag to the wye of the pre-use settings. Attach a caution tag in a
circuit. Set the test lung bag to accept a tidal prominent position so the user is aware that
volume of 500 mL, then ventilate the test lung control settings may have been changed.
bag by squeezing the reservoir bag, making sure
that the test lung bag completely deflates before

Health Devices Inspection and Preventive Maintenance System 2001 ECRI. All Rights Reserved.
Page 11 of 11