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Anesthesia Unit Vaporizers: Procedure/Checklist 436-0595

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Procedure/Checklist 436-0595

Anesthesia Unit Vaporizers


Used For:
Anesthesia Unit Vaporizers [10-144]

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

ECRI-Recommended Interval Used


Type Interval* By Hospital Time Required
Major 6 months months . hours
Minor NA months . hours
* Additional periodic calibration and preventive maintenance is normally required annually or biannually (see
manufacturer’s recommendation). Only qualified personnel trained and experienced in this function should
perform this additional servicing.

Overview smaller stream, which acts as the carrier gas, passes


through the vaporizing chamber containing the anes-
An anesthesia unit vaporizer is used to vaporize a thetic agent and becomes saturated with agent vapor;
liquid anesthetic agent and deliver a controlled the remainder of the gas bypasses this chamber. A
amount to the patient. wick may be used in the vaporizing chamber to provide
increased surface area for efficient evaporation of the
According to the American Society for Testing and
drug and saturation of the carrier gas. The saturated
Materials (ASTM) standard ASTM F1161-88, anesthetic
carrier gas leaves the chamber and mixes with the
agent vaporizers are required to be concentration cali-
bypass gas. One adjustment is made to set the desired
brated (i.e., a calibrated knob controls the output con-
concentration. This adjustment simultaneously bal-
centration). Older vaporizers, such as the Copper
ances the carrier and bypass flows to produce the blend
Kettle and the Vernitrol, do not have a single control
required for the set concentration. The mixture exits
for selecting the concentration of anesthetic vapor.
the vaporizer and is delivered from the anesthesia
Where possible, these units should be removed from
machine as the fresh gas to be inspired by the patient.
service. Contemporary concentration-calibrated va-
porizers are of two types: variable bypass and heated
blender. Evaporation of the liquid agent contained in the
chamber is driven by heat absorbed from the walls of
Conventional (variable-bypass) vaporizers. In a the vaporizer; consequently, when evaporation is oc-
variable-bypass vaporizer, the total background gas curring, the vaporizer and its contents cool. Because
flow that enters the unit is split into two streams. The the equilibrium vapor pressure of an agent changes

009006 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA


436-0595 Telephone +1 (610) 825-6000 ● Fax +1 (610) 834-1275 ● E-mail info@ecri.org
A NONPROFIT AGENCY
Inspection and Preventive Maintenance System

pass vaporizer. As a result, the variable-bypass design


was abandoned for desflurane, and Ohmeda developed
a new vaporizer, the Tec 6, based on a heated-blender
design. Figure 2 shows a schematic of this vaporizer.

A version of the Tec 6 (also manufactured by Oh-


meda) has been adapted for Drager machines and is
compatible with the Drager triple-exclusion interlock
system. As of this writing, neither Drager nor Sie-
mens has developed its own desflurane vaporizer.

A desflurane vaporizer requires electrical power to


heat the agent to a thermostatically controlled 39°C,
producing a stable, saturated vapor pressure of
1,500 mm Hg. No wick is used, and no carrier gas
enters the sump chamber. Instead, a stream of vapor
under pressure flows out of the sump; this stream
blends with the background gas stream, which origi-
nates from the anesthesia machine’s flowmeters, to
Figure 1. Schematic illustrating the basic elements of a achieve the desired concentration.
vaiable-bypass vaporizer
The background gas stream passes through a fixed-
flow resistor, producing a back pressure upstream of
with temperature, a temperature-sensitive mecha-
this resistor that is proportional to the background gas
nism is used to automatically adjust the carrier and
flow. The desired desflurane concentration is set on the
bypass flows to compensate for temperature changes.
dial of the adjustable metering valve in the vapor
Figure 1 presents a schematic of a variable-bypass
stream; this setting produces a predetermined aper-
vaporizer.
ture. The pressure in the vapor upstream of the aper-
Desflurane (heated-blender) vaporizers. Desflu- ture and the back pressure in the background gas
rane, a volatile inhalation anesthetic marketed by stream are continually sensed by a differential pres-
Ohmeda Pharmaceutical Products Division under the sure transducer. The transducer controls a pressure-
trade name Suprane, has characteristics that differ regulating valve in the vapor stream between the sump
markedly from those currently in use — enflurane, ha-
lothane, and isoflurane; for example, its low solubility
allows rapid induction of and emergence from anesthe-
sia. Thus, by increasing the speed of recovery, desflurane
has the potential to shorten hospital stays (although this
has not yet been consistently demonstrated).

The boiling point of desflurane — 22.9°C at 760 mm


Hg — is just above room temperature; therefore, small
increases in ambient temperature or decreases in atmos-
pheric pressure can cause it to boil. Also, because of
desflurane’s high minimum alveolar concentration, or
MAC (i.e., its low potency), evaporation of sufficient
agent to achieve a given anesthetic effect would require
much more heat absorption from the vaporizer than
occurs with other agents. Furthermore, the change in
vapor pressure of desflurane per change in temperature
is as much as three times that for the other volatile
agents at sea-level atmospheric pressure. These pro-
found effects of temperature and ambient pressure on
the vapor pressure of desflurane make stabilizing the Figure 2. Schematic illustrating the basic elements of the
delivered concentration at a set point extremely difficult Ohmeda Tec 6 vaporizer
in a passive mechanical system, such as a variable-by-

Inspection and Preventive Maintenance System


2 ©1995 ECRI. All Rights Reserved.
Anesthesia Unit Vaporizers

and the adjustable metering valve. The pressure-regu- Do not fill a vaporizer with an inhalation agent
lating valve permits only that flow from the sump unless you are qualified to do so. Always use a scav-
necessary to cause the pressure upstream of the ad- enging system or appropriate ventilation when in-
justable metering valve to equal the back pressure in specting vaporizers. For personal safety, when
the background gas stream. In this way, the ratio of inspecting vaporizers alone, notify other personnel of
the adjustable metering valve’s resistance to the resis- your location. Be sure that filler ports are tightly
tance of the fixed-flow resistor determines the ratio of capped before passing gas through the vaporizer.
the flows in each stream, and therefore, the concentra-
tion of vapor in the blended output. If the flow from the Procedure
anesthesia machine’s flowmeters through the vapor- Before beginning an inspection, carefully read this
izer is altered, the flow of vapor from the sump is procedure and the manufacturer’s instruction and serv-
automatically adjusted so that the pressures at the two ice manuals; be sure that you understand how to oper-
monitored points remain equal, the flow ratio does not ate the equipment and the significance of each control
change, and the output concentration continues to and indicator. Also determine whether any special in-
match its setting. spection or preventive maintenance procedures or fre-
The control circuits and heating elements in the quencies are recommended by the manufacturer.
vaporizer are turned on by the act of connecting the Note: This procedure should be done simultaneously
vaporizer to electrical power. The unit then heats to with Anesthesia Units Procedure/Checklist 400,
and remains at operating temperature as long as it where leak testing of the vaporizer has been included
receives power, whether it is delivering agent or is in with the anesthesia unit.
the standby mode. Consequently, it is warm to the
touch while plugged into a live socket. Each vaporizer should have a separate control
number. Inspection documentation for up to three
Citations from Health Devices vaporizers (on one anesthesia unit) can be included on
Avoiding anesthesia mishaps through pre-use checks, one inspection form (record each control number), but
1982 May; 11:210-3. some hospitals may prefer to use a separate form for
each vaporizer.
Water in halothane vaporizers [Hazard], 1985 Aug;
14:326. Be sure that the anesthesia system is level and
secure. Check that all hoses and fittings are tight.
Anesthesia units with a flowmeter-controlled vapor-
izer [Hazard], 1986 Dec; 15:336. 1. Qualitative tests
Vaporizer leak with Mapleson breathing circuits [Haz- 1.1 Chassis/Housing. Examine the exterior of the
ard], 1986 Dec; 15:344-5. unit for cleanliness and general physical condi-
tion. Be sure that housings are intact, that all
Concentration calibrated vaporizers [Hazard], 1987 assembly hardware is present and tight, and
Mar-Apr; 16:112-3. that there are no signs of spilled liquids or other
Pre-use anesthesia check fails to find faults [Hazard], serious abuse.
1988 Sep; 17:274-6. 1.2 Mount/Fasteners. Check security of mounts or
Desflurane (Suprane): Considerations for introduc- support mechanisms. Verify that the vaporizer
ing the new inhalation anesthetic agent into clinical is firmly mounted on the anesthesia unit.
practice [Guidance article], 1994 Apr; 23:131-42. 1.4 AC Plug. If the unit is so equipped, examine the
AC power plug for damage. Attempt to wiggle
Test apparatus and supplies the blades to determine that they are secure.
Halogenated anesthetics analyzer Shake the plug and listen for rattles that could
Hoses and adapters indicate loose screws. If any damage is sus-
pected, open the plug and inspect it.
Special precautions 1.5 Line Cord. Inspect the cord, if so equipped, for
As a general precaution, a vaporizer containing an signs of damage. If damaged, replace the entire
anesthetic agent should not be tipped. If such tipping cord, or if the damage is near one end, cut out the
occurs, notify the user and follow the manufacturer’s defective portion. Be sure to wire a new power cord
recommended procedures for airing or drying the unit. or plug with the same polarity as the old one.

Inspection and Preventive Maintenance System


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

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

1.13 Controls. Before moving any controls, check 2. Quantitative tests


their positions. If any of them appear inordinate
2.1 Grounding Resistance. If the unit is electrically
or are left in the on position, consider the possi-
powered, use an ohmmeter, electrical safety ana-
bility of inappropriate clinical use or of incipient
lyzer, or multimeter with good resolution of frac-
device failure.
tional ohms to measure and record the
Examine all controls for physical condition, resistance between the grounding pin of the
secure mounting, and correct motion. Where a power cord and exposed (unpainted and not ano-
control should operate against fixed-limit stops, dized) metal of the chassis. We recommend a
check for proper alignment, as well as positive maximum of 0.5 Ω
stopping. During the course of the inspection, be
2.2 Leakage Current. For electrically powered
sure to check that each control performs its
units, measure chassis leakage current to the
proper function. Return all controls to the off
chassis of the device with the grounding conduc-
position following the test.
tor of plug-connected equipment temporarily
1.16 Fluid Levels. Check all fluid levels. If the fluid opened. Operate the device in all normal modes,
level is zero, we recommend that you have a including On, Standby, and Off, and record the
qualified user fill the sump with anesthetic maximum leakage current. Leakage current
agent to continue the inspection. should not exceed 300 µA.

1.17 Battery. Inspect the physical condition of the 2.10 Concentration Check. Data for up to three va-
battery and battery connectors, if so equipped porizers can be recorded as Items 2.10, 2.11, and
and readily accessible. Operate the battery-pow- 2.12. Record the type and control number of the
ered functions of the unit for several minutes to vaporizer being tested under each item.
check that the battery has an adequate charge.
2.11 See Item 2.10
Check remaining battery capacity by activating
the battery test function or measuring the out- 2.12 See Item 2.10
put voltage. If it is necessary to replace a battery,
label it with the date. Because there are various types of halogen-
ated anesthetic analyzers, follow the manufac-
1.18 Indicators/Displays. During the course of the turer’s procedure for setup and use of the
inspection, confirm the operation of all indica- analyzer.
tors and visual displays on the unit, if so
equipped. Vaporizers should usually be tested with an
oxygen flow of 4 to 5 L/min (nitrous oxide may
1.20 Alarms/Interlocks. Operate the device in such affect the readings of some vapor analyzers).
a way as to activate each audible and visual Test the vaporizers at low, medium, and high
alarm, if so equipped. If the device has an alarm- concentration settings in the normal clinical use
silence feature, check the method of reset (i.e., range (e.g., 0.5%, 1.0%, and 3.0% for halothane).

Inspection and Preventive Maintenance System


4 ©1995 ECRI. All Rights Reserved.
Anesthesia Unit Vaporizers

At one concentration setting (e.g., 1.0% for ha- 3.2 Replace the battery, if so equipped (battery
lothane, 10% for desflurane), test the vaporizer should be replaced at least once annually).
at another flow (e.g., 1 L/min). We recommend
that the concentration be ±0.3% vapor or ±10% 4. Acceptance tests
of the measured value, whichever is greater. If
errors in concentration are observed, allow the Conduct major inspection tests for incoming vapor-
vaporizer to operate for a minute or two and izers and, if a vaporizer is position sensitive, any time
recheck the unit. Some units may require a it is demounted from an anesthesia unit.
short stabilization period.
Before returning to use
3. Preventive maintenance Return all controls to the off position, level and
3.1 Clean the exterior. secure the unit, and tighten all fittings and tubing.

Inspection and Preventive Maintenance System


©1995 ECRI. All Rights Reserved. 5
Procedure Checklist 461-0595

Anesthesia Unit Ventilators


Used For:
Anesthesia Unit Ventilators [10-145]

Commonly Used In: Delivery rooms and operating rooms


Scope: Applies to ventilators used to deliver inhalation anesthetic agents during surgical procedures that
require general anesthesia
Risk Level: ECRI Recommended, High; Hospital Assessment,

ECRI-Recommended Interval Used


Type Interval By Hospital Time Required
Major 6 months* months . hours
Minor NA months . hours
* Inspection and preventive maintenance intervals should be scheduled according to the manufacturer’s
recommendations. However, units should have a major inspection at least every six months. Pre-use checks
should be performed before each case by the anesthetist who will be operating the equipment.

Overview In general, an anesthesia ventilator is less sophisti-


cated than a critical care ventilator, having only a
Patients undergoing surgery under general anesthesia control mode of operation, with time cycling. (However,
are routinely paralyzed with muscle relaxants to sta- there is at least one ICU-type ventilator that can be
bilize the surgical field. Consequently, they are unable used to administer inhalation anesthetics.) A pressure
to breathe on their own and must be mechanically limit prevents exposure of the lungs to excessive pres-
ventilated either manually by the anesthetist, who sure. Several other breathing waveshape parameters
squeezes a reservoir bag in the breathing circuit, or (e.g., inspiratory:expiratory [I:E] ratio, tidal volume,
automatically by an anesthesia ventilator. A switch minute volume, flow) are settable by the operator and
valve allows the choice of the method by which venti- controlled by the ventilator. Ventilators designed
lation is to be supported. The anesthesia ventilator is solely for anesthetic administration typically do not
typically turned on and off independently of the switch- have compressors.
ing between manual and automatic ventilation.
During extended procedures and procedures involv-
Anesthesia ventilators use positive pressure to in- ing open breathing circuit configurations, a humidifier
flate a patient’s lungs and deliver a prescribed mixture may be included in the breathing circuit. Otherwise, a
of gases and vapors to them. This mixture is produced circle system with an absorber, along with one-way
by the anesthesia machine. The ventilator can be built inspiratory and expiratory valves, is used, typically
into the anesthesia machine or can be a stand-alone without a humidifier. The ventilator’s pressure-relief
unit connected to the machine by gas tubing and, and limit valve(s) should be connected to a waste gas
perhaps, sensor cables. Some anesthesia ventilators scavenging system.
have built-in displays and alarms; others rely on the
sensors, displays, and alarms of the anesthesia ma- Citations from Health Devices
chine to monitor their performance. Anesthesia systems [Evaluation], 1988 Jan; 17:3.

238369 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA


461-0595 Telephone +1 (610) 825-6000 ● Fax +1 (610) 834-1275 ● E-mail info@ecri.org
A NONPROFIT AGENCY
Inspection and Preventive Maintenance System

Who should service anesthesia equipment [User Expe- use by outside vendors can be produced to ensure that
rience NetworkTM], 1988 Feb; 17:70. those items agreed upon are performed by the vendor.

Barotrauma from anesthesia ventilators [Hazard], The following framework should be supplemented
1988 Nov; 17:354. by the manufacturer’s recommended preventive main-
tenance procedures for mechanical ventilators.
Damage to elastic components from Loctite [Hazard],
1989 Jul-Aug; 18:288. 1. Qualitative tests
Risk of barotrauma and/or lack of ventilation with 1.1 Chassis/Housing. Examine the exterior of the
ventilatorless anesthesia machines [Hazard], 1994 unit for cleanliness and general physical condition.
Jan-Feb; 23:54. Be sure that plastic housings are intact, that all
hardware is present and tight, and that there are
Test apparatus and supplies no signs of spilled liquids or other serious abuse.
Lung simulator with adjustable compliance or ven- 1.2 Mount/Fasteners. Check that ventilators
tilator tester mounted in anesthesia machines are properly
Pressure gauge or meter with 2 cm H2O resolution installed. If the device is mounted on a stand or
from -20 to +120 cm H2O cart, examine the condition of the mount. If it is
attached to a wall or rests on a shelf, check the
Various breathing circuit adapters security of this attachment. Check the mounting
Leakage current meter or electrical safety analyzer security of all components.
Ground resistance ohmmeter 1.3 Casters/Brakes. If the device moves on casters,
Additional items as required for specific manufac- check their condition. Verify that they turn and
turers’ procedures swivel, as appropriate, and look for accumula-
tions of lint and thread around the casters.
Check the operation of brakes and swivel locks,
Procedure if the unit is so equipped.
Before beginning an inspection, carefully read this
procedure and the manufacturer’s instruction and 1.4 AC Plug. Examine the AC power plug for dam-
service manuals; be sure that you understand how to age, if so equipped. Attempt to wiggle the blades
operate the equipment, the significance of each control to check that they are secure. Shake the plug and
and indicator, and the alarm capabilities. Also deter- listen for rattles that could indicate loose screws.
mine whether any special inspection or preventive If any damage is suspected, open the plug and
maintenance procedures or frequencies are recom- inspect it.
mended by the manufacturer.
1.5 Line Cord. Inspect the cord for signs of damage,
Manufacturers’ recommended procedures for in- if so equipped. If damaged, replace the entire
spection and preventive maintenance of mechanical cord or, if the damage is near one end, cut out the
anesthesia ventilators vary in both methods and re- defective portion. Be sure to wire a new power
quired accuracy. In addition, ventilator controls can cord or plug with the correct polarity. Also check
vary greatly among manufacturers and models. This line cords of battery chargers.
procedure provides the basic framework for complete 1.6 Strain Reliefs. Examine the strain reliefs at
ventilator inspection and preventive maintenance. both ends of the line cord, if so equipped. Be sure
Manufacturers’ recommended procedures should be that they hold the cord securely.
added where appropriate. References to specific pages
of the manufacturer’s manual should be added to the 1.7 Circuit Breaker/Fuse. If the device has a switch-
checklist. (The checklist includes blank spaces for the type circuit breaker, check that it moves freely. If
insertion of these reference numbers.) the device is protected by an external fuse, check
its value and type against that marked on the
IPM Task ManagerTM, the software component of the chassis, and ensure that a spare is provided.
Inspection and Preventive Maintenance System, en-
ables easy production of customized procedures and 1.8 Tubes/Hoses. Check the condition of all tubing
checklists for specific ventilator models and clinical and hoses. Be sure that they are not cracked,
needs. Items performed by outside vendors can be kinked, or dirty. Check that they are connected
excluded from the checklist; a separate checklist for to the correct locations.

Inspection and Preventive Maintenance System


2 ©1995 ECRI. All Rights Reserved.
Anesthesia Unit Ventilators

1.9 Cables. Inspect any cables (e.g., for sensors) and 1.17 Battery/Charger. Inspect the physical condition
their strain reliefs for general condition. Care- of batteries and battery connectors, if so equipped
fully examine cables to detect breaks in the in- and if readily accessible. Check operation of
sulation and to ensure that they are securely battery-operated power-loss alarms, if so
gripped in the connectors at each end, which will equipped. Operate the unit on battery power for
prevent rotation or other strain. Where appro- several minutes to check that the battery is
priate, verify that there are no intermittent charged and can hold a charge. (The inspection
faults by flexing cables near each end and look- can be carried out on battery power to help
ing for erratic operation or by using an ohmme- confirm adequate battery capacity.) Check bat-
ter. tery condition by activating the battery test func-
tion or measuring the output voltage; for
1.10 Fittings/Connectors. Examine all gas fittings lead-acid batteries, measure the specific gravity
and connectors for general condition. Gas fit- and check the fluid level. Check the condition of
tings should be tight and should not leak. Verify the battery charger and, to the extent possible,
that keyed connectors (e.g., pin-indexed gas con- confirm that it does, in fact, charge the battery.
nectors) are used where appropriate, that all Be sure that the battery is recharged or charging
pins are in place and secure, and that keying is when the inspection is complete. When it is nec-
correct. Connectors to hospital central piped essary to replace a battery, label it with the date.
medical gas systems should have the appropri-
ate DISS or quick-connect fitting to eliminate the 1.18 Indicators/Displays. During the course of the
need for adapters. inspection, confirm the operation of all lights,
indicators, meters, gauges, and visual displays
1.12 Filters. Check the condition of gas filters, if in- on the unit and charger (if so equipped). Be sure
cluded in the unit. Check for corrosion residue that all segments of a digital display function.
indicative of liquid, gaseous, or solid particle Record the reading of an hour meter, if present.
contaminants in the gas supply; if found, notify
1.20 Alarms/Interlocks. Induce alarm conditions to ac-
appropriate personnel. Clean or replace if appro-
tivate audible and visual alarms. Check that any
priate, and indicate this on Lines 3.1 and 3.4 of
associated interlocks function. If the unit has an
the inspection form.
alarm-silence feature, check the method of reset
(i.e., manual, automatic) against the manufac-
1.13 Controls/Switches. Before changing any con-
turer’s specifications. It may not be possible to
trols or alarm limits, check their positions. If any
check out all alarms at this time since some may
settings appear inordinate (e.g., alarm limits at
require special conditions that must be established
the ends of their range), consider the possibility
according to the manufacturer’s recommenda-
of inappropriate clinical use or of incipient device
tions; include these in Item 2.4. Verify that any
failure. Record the settings of those controls that
remote alarm indicator (e.g., within the main-
should be returned to their original positions
frame anesthesia unit) functions properly.
following the inspection.
1.22 Labeling. Check that all necessary placards, la-
Examine all controls and switches for physical bels, and instruction cards are present and legible.
condition, secure mounting, and correct motion.
Check that control knobs have not slipped on 1.23 Accessories. Confirm the presence and condition
their shafts. Where a control should operate of accessories. Check the condition of reusable
against fixed-limit stops, check for proper align- Bain circuit and adapters, if available.
ment, as well as positive stopping. Check mem-
1.24 Bellows. Check the physical condition and
brane switches for damage (e.g., from
proper operation of the bellows.
fingernails, pens). During the inspection, be sure
to check that each control and switch performs 2. Quantitative tests
its proper function.
2.1 Grounding Resistance. Using an ohmmeter, elec-
1.15 Fan. Check physical condition and proper op- trical safety analyzer, or multimeter with good
eration, if so equipped. Clean and lubricate if resolution of fractional ohms, measure and record
required, according to the manufacturer’s in- the resistance between the grounding pin of the
structions, and note this on Lines 3.1 and 3.2 of power cord and exposed (unpainted and not ano-
the form. dized) metal on the chassis of the ventilator or of

Inspection and Preventive Maintenance System


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

the system in which the ventilator is mounted. Volume (e.g., tidal volume, minute volume,
We recommend a maximum of 0.5 Ω. If the apnea)
ventilator is a component within an anesthesia Fraction of inspired oxygen (FIO2; see Oxygen
unit, grounding and leakage current measure- Analyzers Procedure/Checklist 417)
ments can be referenced to that unit.
Alarm settings (e.g., high PIP, low MAP, low
2.2 Leakage Current. Measure chassis leakage cur- pressure, low FIO2) should be inspected for
rent to ground with the grounding conductor of proper and accurate activation.
plug-connected equipment temporarily opened.
Operate the device in all normal modes, includ- 2.5 Gas Supply.
ing on, standby, and off, and record the maxi-
Pneumatic lines (including air filters). Verify
mum leakage current.
that appropriate gas-specific connectors are
Measure chassis leakage current with all ac- used. Check gas filters, if so equipped and
cessories normally powered from the same line accessible.
cord connected and turned on and off. This in- Gas cylinders (and gauges and regulators, if so
cludes other equipment that is plugged into the equipped). Verify that these are present, se-
primary device’s accessory receptacles, as well as curely mounted, and in good condition and
equipment plugged into a multiple-outlet strip that there is an adequate gas supply. Verify
(“Waber strip”) so that all are grounded through that one and only one washer is used to seal
a single line or extension cord. the tank to its yoke. Verify that all index pins
Chassis leakage current to ground should not are present and protruding to the proper
exceed 300 µA. length to engage the hole in the tank valve
stem and in the correct positions for the gas to
2.3 Modes and Settings. Anesthesia ventilators are be supplied through the yoke.
usually equipped only with a control mode. How-
ever, specialized units may have additional 2.6 Patient Circuit.
modes such as assist/control and pressure sup- Breathing circuit (including filters). Verify that
port. Adjustable positive end-expiratory pres- these components are compatible with the ven-
sure (PEEP) may also be available. The function tilator according to the manufacturer’s recom-
of these modes should be inspected and verified mendations (see Health Devices 1988 Apr;
for proper operation. Check the operation and 17:109). Check for leaks, the absence of obstruc-
accuracy of ventilation controls, which may in- tions, and proper flow direction in the breathing
clude tidal volume, breath rate, inspiratory time, circuit, ensuring the proper assembly and func-
expiratory time, I:E ratio, pressure limit, or flow. tion of fittings, adapters, the CO2 absorber, in-
Typically, these tests are performed by attaching spiratory and expiratory valves and PEEP
the ventilator to a lung simulator or ventilator valves, the APL valve, the scavenger, and other
tester and comparing measured values to set- components. With the ventilator connected to
tings on the ventilator. The manufacturer should the anesthesia system, check for leaks in the
recommend the appropriate ventilator settings entire system, including the breathing circuit.
(e.g., tidal volume, rate, inspiratory time) to ver- This does not have to be duplicated if done as
ify proper operation and accuracy (generally part of the Anesthesia Units procedure (see
within 10%). Procedure/Checklist 400).
2.4 Monitors and Alarms. The following breathing Humidifiers. See Heated Humidifiers Proce-
circuit parameters may be monitored by the ven- dure/Checklist 431.
tilator or by the system in which the ventilator
is mounted. They should be inspected for accu- Pressure-Relief Mechanism. Check the proper
racy (generally within 10%) according to the operation of the pressure-relief mechanism by
manufacturer’s specifications: occluding the breathing circuit and measuring
the resulting peak pressure on the pressure
Breathing rate gauge. Verify that pressure is vented in the
Inspiratory time breathing circuit.
Airway pressure (e.g., PIP, PEEP, MAP, ap- Absorber. See Anesthesia Units Proce-
nea) dure/Checklist 400.

Inspection and Preventive Maintenance System


4 ©1995 ECRI. All Rights Reserved.
Anesthesia Unit Ventilators

3. Preventive maintenance Before returning to use


3.1 Clean the exterior and interior, if needed. Ensure that all controls are set properly. Set alarms
loud enough to alert personnel in the area in which the
3.3 Calibrate according to manufacturer’s instructions.
device will be used. Other controls should be in their
3.4 Replace components according to the manufac- normal pre-use positions.
turer’s instructions.
Attach a Caution tag in a prominent position so that
4. Acceptance tests the user will be aware that control settings may have
been changed.
Conduct major inspection tests for this procedure
and the appropriate tests in the General Devices Pro- Recharge battery-powered devices, or equip them
cedure/Checklist 438. with fresh batteries, if needed.

Inspection and Preventive Maintenance System


©1995 ECRI. All Rights Reserved. 5
Procedure/Checklist 400-0595

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

Also Called: Anesthesia machines, anesthesia workstations


Commonly Used In: Operating rooms, 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/Checklist 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/Checklist 461)
Risk Level: ECRI Recommended, High; Hospital Assessment,

ECRI-Recommended Interval Used


Type Interval By Hospital Time Required
Major 6 months months . hours
Minor NA months . hours

Overview a health hazard to chronically exposed OR personnel


and unborn children. Inadvertent switching of gas
Most surgical procedures are performed while the pa- supplies, failure of an alarm to respond to an exces-
tient is under general anesthesia. Usually, the patient sively low oxygen pressure, and misconnected or im-
is anesthetized by a narcotic or barbiturate injection properly calibrated flowmeters have also caused
followed by administration of an inspired gas mixture anesthesia-related accidents.
of oxygen, nitrous oxide, and the vapor of a volatile
Because mishandling and mistakes can have severe
liquid anesthetic, typically a halogenated hydrocar-
consequences, life-support devices such as anesthesia
bon. The anesthesia unit administers this mixture of
units should be operated and inspected only by quali-
anesthetic gases and life-sustaining oxygen, varying
fied personnel who have a thorough knowledge of the
the proportions to control the patient’s level of con-
units and their functions. If you are unsure of any
sciousness. If respiratory assist is necessary (e.g., in
aspect of the procedure, consult the manufacturer be-
cases of muscular blockade), a ventilator may be con-
fore inspecting an anesthesia unit.
nected to the patient breathing system to force the gas
mixture into the patient’s lungs. The anesthesia unit consists of four systems: the gas
supply system, the gas control system, the vaporizers,
Improperly modified or inadequately maintained and the breathing system.
anesthesia units have injured and killed patients
and hospital personnel. Gas leaks can adversely Gas supply. This system delivers a variety of gases
affect the accuracy of gas delivery to the patient, as to the patient. Cylinders containing oxygen and other
well as add anesthetic agents to the OR atmosphere. gases at high pressure (see Table 1) are connected to
Trace levels of anesthetics have been implicated as the high-pressure system of the anesthesia unit by

009005 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA


400-0595 Telephone +1 (610) 825-6000 ● Fax +1 (610) 834-1275 ● E-mail info@ecri.org
A NONPROFIT AGENCY
Inspection and Preventive Maintenance System

TABLE 1. Gases Used in Anesthesia Machines


Gas Chemical Color Code: Color Code: Service Pressure,
Formula U.S. International psi 21°C, Full Cylinder
Oxygen O2 Green White 1,800-2,400*
Carbon Dioxide CO2 Gray Gray 838
Nitrous Oxide N2O Blue Blue 745
Helium He Brown Brown 1,600-2,000*
Air Yellow White and Black 1,800

* Depends on cylinder size.

yoke fittings that comply with the Compressed Gas normally attached to the anesthesia unit as a reserve
Association (CGA) pin-index safety system (see Figure source if the central supply fails or if central supply
1). Unique placements of pins and mating holes on the outlets are not available.
pin-index fittings prevent connection of a gas cylinder
to the wrong inlet. Inside the unit, each high-pressure Centrally supplied gases are delivered directly to the
gas flows through a filter, a check valve (for one-way intermediate-pressure gas control system at approxi-
flow), and a regulator that reduces the pressure to mately 50 psi through low-pressure hoses and connec-
approximately 45 psi. tors. These connectors may not comply with a universal
standard safety system, but each is designed to prevent
Because oxygen and nitrous oxide are used in rela- mismating the gas supply and the machine inlet.
tively large quantities, they are usually drawn from
the hospital’s central gas supplies, which are more Some units may provide an oxygen power outlet to
convenient and economical than compressed-gas cyl- drive auxiliary devices (e.g., a ventilator).
inders. However, cylinders of these gases are also Gas control. This system regulates gas flow rates so
that the gases can be mixed and delivered under accu-
rate, constantly metered control. The operator must
be able to adjust the ratios or make rapid gross changes
in flow rates without inducing system interactions that
cause temporary delivery of undesirable mixtures.

The flow of each gas is controlled by a valve and


indicated by a glass-tube flowmeter. After gases pass
the control valve and enter the low-pressure system,
they can be administered to the patient.

A fail-safe provision in many anesthesia units pro-


tects the patient against a fall in pressure of life-sus-
taining oxygen. If the oxygen pressure drops below
about 25 to 30 psi, some units shut off the flow of all
other gases, while others reduce all gas flow rates in
proportion to the drop in oxygen pressure. Newer
anesthesia machines have additional safety systems
that provide a minimum percent of oxygen (around
25%) and/or deliver a minimum flow of oxygen (usually
CGA Connector 150 to 250 mL/min) (see Item 2.11).
Gas Index Pins Number
Oxygen 2-5 870 Vaporizers. These devices add the vapor of a volatile
Nitrous Oxide 3-5 910 liquid anesthetic (e.g., halothane, isoflurane, enflurane,
O2 - CO2 (CO2<7%) 2-6 880
O2 - CO2 (CO2>7%) 1-6 940 sevoflurane, desflurane) to the gas mixture, when de-
O2 - HE (He > 80%) 4-6 930 sired, and aid in controlling the vapor concentration.
O2 - HE (He < 80%) 2-4 890
Air 1-5 950 According to the American Society for Testing and
Materials (ASTM) standard ASTM F1161-88, anes-
Figure 1. Pin-index safety system thetic agent vaporizers are required to be concentra-
tion calibrated (i.e., a calibrated knob controls the

Inspection and Preventive Maintenance System


2 ©1995 ECRI. All Rights Reserved.
Anesthesia Units

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

Inspection and Preventive Maintenance System


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

Citations from Health Devices have a minimum pressure of 745 psi for nitrous
oxide and 1,000 psi for oxygen
Anesthesia units with a flowmeter-controlled vapor-
izer [Hazard], 1986 Dec; 15:336-7. Nondisposable corrugated breathing hose (dispos-
able tubing may not provide reliable connections)
Vaporizer leak with Mapleson breathing systems
Test lung (reservoir bag with 3 or 5 L capacity)
[Hazard], 1986 Dec; 15:344-5.
Sphygmomanometer bulb with tubing and adapter
Concentration calibrated vaporizers [Hazard], 1987
Leak-detecting solution
Mar-Apr; 16:112-3.
Conductive lubricant for conductive casters (e.g.,
Pre-use testing prevents “helpful” reconstruction of Dow No. 41, graphited oil)
anesthesia components [Hazard], 1987 May;
16:178-9. Trichloroethylene cleaning solvent or solvent rec-
ommended by the manufacturer (be sure to review
Anesthesia systems [Evaluation], 1988 Jan; 17:3-34. the manufacturer’s Material Safety Data Sheet and
see the special precautions below)
Who should service anesthesia equipment [User Expe-
rience NetworkTM], 1988 Feb; 17:70-1. Lubricant as specified by manufacturer

Pre-use anesthesia check fails to find faults [Hazard], Special precautions


1988 Sep; 17:274-6. (Contains pre-use checklist for
ECRI is aware of a number of incidents in which
anesthesia units.)
improperly serviced ventilation or anesthesia equip-
Anesthesia systems [Evaluation Update], 1988 Dec; ment was implicated in patient injury or death. Do not
17:366-7. perform any procedures, adjustments, repairs, or
modifications unless you thoroughly understand the
Anesthesia units and breathing systems [Standard], device and have verified the appropriateness of the
1989 Oct; 18:363. intended actions. Resolve any questions or uncertain-
Monitoring and anesthesia systems: integration and a ties with the manufacturer, the anesthetist, or ECRI
new option, 1991 Mar-Apr; 20:131-2. before placing a unit into use.

Use of inadequate (old) anesthesia scavenger inter- To avoid the adverse effects of exposure to anes-
faces [Hazard], 1993 Dec; 22:592. thetic gases, all testing should be done with an operat-
ing scavenging system in place or an alternative means
Anesthesia systems [Evaluation]. To be published in to vent excess gases from the vicinity of inspecting
1996. personnel. If a flammable anesthetic is used, be sure
all traces of the gas are cleared away before performing
Test apparatus and supplies any electrical tests. Check that all valves, including
Pressure gauge or meter, -10 to +80 cm H2O (accu- the gas cylinder stem valves, are turned off at the
racy ±5 cm H2O at 30 cm H2O) beginning of the inspection. Turn all valves off again
when the inspection is complete.
Flowmeters with ranges of approximately 0.1 to 1.0
L/min and 1 to 10 L/min, ±2% accuracy, calibrated When testing cyclopropane flowmeters, observe
separately for each of the gases used with the anes- noted procedures to avoid a buildup of explosive levels
thesia machine, and one flowmeter for 10 to 100 of cyclopropane.
L/min (±10% of reading)
Trichloroethylene is a common solvent particularly
Stopwatch or watch with a second hand recommended for cleaning oxygen fittings because it
Hoses and adapters for connecting pressure gauges does not leave a residue that is flammable in high-con-
or meters and flowmeters to equipment being in- centration oxygen. However, this solvent reacts with
spected the soda lime used in carbon dioxide absorbers to form
several poisonous gases, including phosgene. Al-
Cylinder of each type of gas used with the unit though concentrations may not be lethal, the presence
being inspected; each cylinder on a unit that is of these gases to any degree is highly undesirable.
ready for use should be more than half full if the
gas is normally stored in gaseous form (e.g., oxy- To prevent the generation of these gases, make sure
gen) and should contain some liquid if the gas is that equipment recently cleaned with trichlo-
normally liquefied for storage; cylinders should roethylene is completely dry before using. When clean-

Inspection and Preventive Maintenance System


4 ©1995 ECRI. All Rights Reserved.
Anesthesia Units

ing parts of the anesthesia unit with this solvent, first 1.6 Strain Reliefs. Examine the strain reliefs at
disconnect the line to the carbon dioxide absorber. both ends of the line cord. Be sure that they hold
After cleaning, allow time for the solvent to evaporate. the cord securely.
When the parts appear dry, take the added precaution
of briefly flushing them with a high oxygen flow rate. 1.7 Circuit Breaker/Fuse. If the device has a
switch-type circuit breaker, check that it moves
Procedure freely. If the device is protected by an external
fuse, check its value and type against that
Before beginning an inspection, carefully read this marked on the chassis, and ensure that a spare
procedure and the manufacturer’s instruction and is provided.
service manuals; be sure that you understand how to
operate the equipment, the significance of each control 1.8 Tubes/Hoses. Check the condition of all tubing
and indicator, and the alarm capabilities. Also deter- and hoses. Be sure that they are not cracked,
mine whether any special inspection or preventive kinked, or dirty.
maintenance procedures or frequencies are recom-
mended by the manufacturer. 1.9 Cables. Inspect the cables (e.g., sensor, elec-
trode) and their strain reliefs for general condi-
1. Qualitative tests tion. Examine cables carefully to detect breaks
1.1 Chassis/Housing. Examine the exterior of the in the insulation and to ensure that they are
unit for cleanliness and general physical condi- gripped securely in the connectors of each end to
tion. Be sure that plastic housings are intact, prevent rotation or other strain.
that all assembly hardware is present and tight,
1.10 Fittings/Connectors. Examine all gas and liq-
and that there are no signs of spilled liquids or
uid fittings and connectors, as well as all electri-
other serious abuse.
cal cable connectors and sockets, for general
1.2 Mount. Check any shelves, brackets, or sup- condition. Electrical contact pins or surfaces
porting structures. Check the security of the should be straight, clean, and bright. Check that
attachments. pins used with the pin-index safety system com-
ply (location and length of protrusion) and are
1.3 Casters/Brakes. If the device moves on casters, intact. Check the yoke clamping screw and
check their condition. Look for accumulations of make sure empty yokes have plugs. Check that
lint and thread around the casters, and be sure appropriate keyed or indexed fittings are being
that they turn and swivel as appropriate. Check used with corresponding gases.
the operation of brakes and swivel locks, if the
unit is so equipped. Check that gas hoses do not 1.12 Filters. Check the condition of all compressed-
lie on the floor or loop near the casters. gas filters. Clean or replace as needed, and indi-
cate this on Line 3.1 or 3.4 of the inspection form.
1.4 AC Plug/Receptacles. Examine the AC power
plug for damage. Attempt to wiggle the blades 1.13 Controls/Switches. Before moving any controls
to determine that they are secure. Shake the and alarm limits, check their positions. If any of
plug and listen for rattles that could indicate them appear inordinate (e.g., a pressure alarm
loose screws. If any damage is suspected, open control at maximum, alarm limits at the ends of
the plug and inspect it. their range), consider the possibility of inappro-
If the device has electrical receptacles for ac- priate clinical use or of incipient device failure.
cessories, insert an AC plug into each and check Record the settings of those controls that should
that it is held firmly. If accessories are plugged be returned to their original positions following
and unplugged often, consider a full inspection the inspection.
of the receptacle.
Examine all controls and switches for physical
1.5 Line Cord. Inspect the cord for signs of damage. condition, secure mounting, and correct motion.
If damaged, replace the entire cord or, if the Where a control should operate against fixed-
damage is near one end, cut out the defective limit stops, check for proper alignment, as well
portion. Be sure to wire a new power cord or plug as positive stopping. During the course of the
with the correct polarity. Also check line cords of inspection, be sure to check that each control and
battery chargers. switch performs its proper function.

Inspection and Preventive Maintenance System


©1995 ECRI. All Rights Reserved. 5
Inspection and Preventive Maintenance System

Check that the concentration dial on each of pressure on the pressure gauge. Watch for any
vaporizer moves freely and that only one vapor- inflation of the flattened bag as a sign of expira-
izer can be on at a time. Observe the float motion tory valve leakage.
as its flow control valve is turned on. The valve
should turn smoothly with only slight drag. Reconnect the bag to the bag mount and the
Each valve should have a definite shutoff posi- hose to the inhalation port. With your hand oc-
tion at which the float should be motionless at cluding the expiratory port, use a test lung to
its zero level. Check for free play in the control again generate about 5 cm H2O of pressure and
valve by pushing, pulling, and gently rocking the check for inspiratory valve leakage by watching
stem from side to side without rotation. The stem for any inflation of the bag.
should feel firm, and the flowmeter float should 1.20 Alarms/Interlocks. Operate the device in such a
not move. The control valve knob should require way as to activate each audible and visual alarm.
turning through at least 90° to change the flow Check that any associated interlocks function
rate from 10% to 100% of full scale. (Note: All (particularly the vaporizer interlocks, which
recent anesthesia units should now have differ- should allow activation of only one vaporizer at a
ent sized and shaped knobs for oxygen and ni- time). If the device has an alarm-silence feature,
trous oxide to aid in differentiating between the check the method of reset (i.e., manual or auto-
two controls.) matic) against the manufacturer’s specifications.
1.17 Battery/Charger. Inspect the physical condi- 1.21 Audible Signals. Operate the device in such a
tion of batteries and battery connectors, if read- way as to activate all audible signals. Confirm
ily accessible. Check the battery-operated appropriate volume, as well as the operation of
power-loss alarms on AC and pneumatic devices, a volume control, if so equipped. Check that the
if so equipped. Operate the unit on battery power audible signals are appropriate for the test con-
for several minutes to check that the battery has ditions used.
an adequate charge. Check remaining battery
capacity by activating battery test function or 1.22 Labeling. Check that all necessary placards, la-
measuring the output voltage. If appropriate, bels, conversion charts, and instruction cards
check the condition of the battery charger and, are present and legible. Check for proper color
to the extent possible, confirm that it does, in coding for corresponding parts (e.g., green for
fact, charge the battery. When it is necessary to oxygen, blue for nitrous oxide).
replace a battery, label it with the date.
1.23 Accessories. Verify accuracy and function of any
1.18 Indicators/Displays. During the course of the accessories (e.g., spirometer, sphygmomanome-
inspection, confirm the operation of all lights, ter gauge). (Inspect ventilators, vaporizers, and
indicators, meters, gauges, and visual displays oxygen monitors separately using the appropri-
on the unit and charger, if so equipped. Be sure ate procedures, and record on separate forms.)
that all segments of a digital display function.
1.24 Fail-Safe Oxygen Valves and Alarms. Close all
1.19 Directional Valves. Check that directional control valves. Open all cylinder stem valves
valves are free from cracks and chips and fit and external gas source valves. Connect gas
smoothly against the valve seats. Check for free scavenging or other evacuation system to com-
movement by shaking or lightly squeezing the mon gas outlet. Turn on the main gas control,
hose connecting the two valves. The valves and open the flow control valves until the flow-
should flutter up and down and should not stick meter for each gas reads midscale. Then discon-
to their seats. nect or turn off all oxygen sources. The flow of
other gases should fall or stop as the oxygen flow
Check for the possibility of reverse flow decreases to half its previous level. All gas flow
through directional valves by removing the should cease when the oxygen flow reaches zero.
breathing hoses from the absorber and attach- (Cyclopropane flow rate normally falls more
ing a thin disposable reservoir bag to the exha- slowly than the others.)
lation port. Attach a piece of hose to the bag
mount, set the control for manual mode, close In addition to the automatic shutoff or reduc-
the APL valve, and occlude the inspiratory port tion of gas flow, audible or visual alarms signify-
with the palm of your hand. Then, connect a test ing low oxygen pressure should have been
lung to the hose and generate about 5 cm H2O activated, if the unit is so equipped. Silence the

Inspection and Preventive Maintenance System


6 ©1995 ECRI. All Rights Reserved.
Anesthesia Units

alarm by raising the oxygen pressure above the Measure chassis leakage current with all ac-
preset alarm limit. If the unit has an alarm that cessories normally powered from the same line
does not respond, check for exhausted batteries cord connected and turned on and off. This in-
or other source of the malfunction. cludes other equipment that is plugged into the
primary device’s accessory receptacles, as well as
1.25 Common Outlet Back-Pressure Check Valve. equipment plugged into a multiple-outlet strip
Most anesthesia units manufactured after 1968 (“Waber strip”) so that all are grounded through
with mounted bubble-through vaporizers have a a single line or extension cord.
check valve in the gas delivery system to prevent
pressures at the outlet (e.g., produced by a ven- Leakage current should not exceed 300 µA.
tilator) from being transmitted to other parts of
2.3 Oxygen Flush Valve. Attach the 100 L/min flow-
the unit where they could affect the accuracy of
meter to the common outlet. Set the oxygen flow
gas delivery and the concentration of anesthetic
rate to a 2 L/min indication on the machine’s
gases.
oxygen flowmeter and actuate the oxygen flush
To test this check valve, attach the -10 to +80 control. The rate should rise to between 35 and
cm H2O pressure gauge or meter to the common 75 L/min. The machine flowmeter indication
gas outlet. Turn off all vaporizers, either filled should remain near 2 L/min unless the manufac-
or empty. Adjust the oxygen flow control valve to turer’s specification shows otherwise. If it falls
maintain an outlet pressure of 30 cm H2O. Turn more than 1 L/min, check for an inadequate
on the vaporizer flow, and readjust, if necessary, oxygen supply, a partially occluded oxygen line
to maintain 30 cm H2O. Carefully open the in the machine, or a dirty oxygen inlet filter.
vaporizer filler cap (to prevent a sudden flow of Cycle the flush control slowly several times; it
oxygen into the vaporizer) and observe the outlet should move smoothly and not have a tendency
gauge pressure. A sudden pressure drop sug- to stick. Check that the oxygen flow returns to
gests a leaky check valve. If the check valve is 2 L/min within 2 sec each time the flush valve is
missing or defective, replace it or alert appropri- closed.
ate personnel to replace the valve to avoid a
possible hazardous buildup of vapor. Note: This 2.4 High-Pressure Leaks. Close all flow control
test may not be possible on newer machines that valves on the machine. Open all cylinder stem
always maintain a minimum flow of oxygen. On valves one full turn, noting any motion of the
such devices, follow the manufacturer’s instruc- flowmeter floats. Float movement indicates a
tions for testing the common outlet back-pres- leaky flowmeter valve. Record pressure gauge or
sure check valve. meter readings, verifying that they are close to
the service pressure values listed in Table 1.
2. Quantitative tests Close the cylinder stem valves. The pressure
drop over 30 sec should be negligible. Excess
2.1 Grounding Resistance. Use an ohmmeter, elec- pressure drop indicates an unacceptable leak
trical safety analyzer, or multimeter with good that should be located and repaired.
resolution of fractional ohms to measure and
record the resistance between the grounding pin 2.5 Intermediate Pressure System. Close all flow
of the power cord and exposed (unpainted and control valves on the anesthesia unit. Connect
not anodized) metal on the chassis. We recom- the hoses to the external pipeline gas source and
mend a maximum of 0.5 Ω. test the supply line hoses with leak-detecting
solution. Note the pressure on the pipeline/cen-
If the device has an accessory outlet, check its tral gas supply pressure gauge. (Most machines
grounding to the main power cord. should have such a gauge. If not, contact the
manufacturer for instructions for testing the in-
2.2 Leakage Current. Measure chassis and patient
termediate pressure system.) Disconnect the gas
lead leakage current to the chassis of the device
supply line hose from the machine, and check
with the grounding conductor of plug-connected
that the pressure drop in 30 sec is negligible.
equipment temporarily opened. Operate the de-
Excessive pressure drop indicates an unaccept-
vice in all normal modes, including on, standby,
able leak that should be located and repaired.
and off, with all monitors and accessories con-
nected to the unit’s accessory power receptacle(s), 2.6 Low-Pressure Leaks. Attach the -10 to +80 cm
and record the maximum leakage current. H2O pressure gauge or meter to the unit’s common

Inspection and Preventive Maintenance System


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

gas outlet and pressurize the outlet section, in- steady 30 cm H2O, indicated on both the test
cluding vaporizers, to approximately 30 cm H2O gauge or meter and the pressure gauge in the
by opening the oxygen flow control valve slightly breathing system, and verify that both gauges
(this is about three times the average working have the same readings. The oxygen flow rate
pressure). Now reduce the flow rate to 30 should be less than 150 mL/min above the leak
mL/min. (Connect a flowmeter to the common measured in Item 2.6.
gas outlet if necessary.) If the gauge or meter
pressure continues to rise, the leak rate is less For anesthesia systems with minimum oxy-
than 30 mL/min at 30 cm H2O (10 mL/min at 10 gen flow, turn the anesthesia machine off and
cm H2O), which is acceptable. If the pressure connect the -10 to +80 cm H2O pressure gauge or
falls, the leakage rate is excessive. Locate the meter to a piece of breathing system tubing that
leak by shutting off all vaporizers and repeating is connected to the inspiratory and expiratory
the test with each vaporizer added in turn. valve outlets. Close the APL valve. Remove the
manual reservoir bag. In its place, connect a
For anesthesia units for which low flow rates stopper with a fitting for a sphygmomanometer
cannot be generated (units that deliver mini- squeeze bulb. Use the bulb to pressurize the
mum flows of oxygen), the low-pressure system breathing system to 50 cm H2O. It should take
can be tested in combination with the breathing at least 30 sec for the pressure to drop from 50
system. Connect the -10 to +80 cm H2O pressure to 30 cm H2O. Less time indicates a leak in the
gauge or meter to a piece of breathing system breathing system that should be corrected.
tubing that is connected to the inspiratory and
expiratory valve outlets. Occlude the outlet to Open the moisture-relief valve. (Note: Due to
the manual reservoir bag and close the APL dust and moisture, some of these valves on older
valve. Turn on the minimum flow of oxygen. units will not turn and might break when force
The pressure gauge or meter should read at least is applied.) The pressure should drop immedi-
30 cm H2O. A reading of less than 30 indicates ately. If the pressure does not drop, clean the
an unacceptable leak that should be corrected. valve of dried soda lime, repeat the pressuriza-
Proceed to Item 2.7 to identify whether the tion, and open the relief valve again.
breathing system is the major source of the leak. 2.8 APL Valve. Leave the setup as in Item 2.7 but
Alternatively, follow the manufacturer’s recom- remove the pressure gauge or meter, replacing it
mendations for testing for low-pressure leaks. with the breathing bag, and restore the normal
2.7 Breathing System. Check the carbon dioxide ab- pressure-limiting valve setting.
sorber housing for cracks or broken edges in the If the APL valve is not the bleeding type,
glass or plastic canister and in the check valve squeeze the bag and verify that the valve holds
domes. pressure until a specific level is exceeded, and
Remove the canister from its holder, without that it then opens. Check that the opening pres-
inverting it, and inspect the gaskets for any sure is adjustable from approximately 1 to at
absorbent dust and wear. Remove any dust from least 30 cm H2O. Other valves, such as the
the bottom of the absorber. If the amount of dust Georgia and Drager valves, may operate in a
seems excessive or if the canister appears seri- completely different manner and at a higher
ously pitted, check for dust in the inspiratory pressure and should be tested according to the
valve and piping, and report the condition to manufacturer’s specified procedure.
department personnel. 2.9 Scavenging System. Insert the pressure gauge or
Check the absorber-elevating mechanism and meter between the APL valve or exhaust port and
clamps for proper operation. the scavenging system intake. Leave the setup as
in Item 2.8, with the APL valve closed or in its
For anesthesia systems without minimum minimum-flow condition. With the scavenging
oxygen flows, connect a breathing hose from the system operating at maximum suction, the pres-
patient inspiration valve to the patient expiration sure gauge or meter reading should be between
valve of the absorber. Close the pressure-limit- -0.5 and 0 cm H2O. Partially open the APL valve,
ing valve. Remove the reservoir bag, and replace and set a 10 L/min oxygen flow rate. With the
it with a -10 to +80 cm H2O pressure gauge or scavenging system at the minimum vacuum, the
meter. Pressurize the system with oxygen to a gauge reading should be near ambient.

Inspection and Preventive Maintenance System


8 ©1995 ECRI. All Rights Reserved.
Anesthesia Units

Repeat the last measurement with the APL stipulated by the manufacturer (usually 100 to
valve fully open while occluding the vacuum hose 250mL/min).
and activating the flush valve for 5 sec. The
pressure should remain at less than 10 cm H2O. Set the flow of oxygen to around 200 mL/min.
Turn off the flow of nitrous oxide. Using an
2.10 Flowmeters. The following procedure applies to oxygen monitor, verify that at least the mini-
each flowmeter on the anesthesia unit. Record mum percent of oxygen (stipulated by the manu-
the data on Line 2.10 (i.e., oxygen, nitrous oxide, facturer) is delivered as the flow of nitrous oxide
and air). If other flowmeters are provided (e.g., is increased.
helium, carbon dioxide), make similar checks
and enter data on the back of the form. 2.12 PEEP Valve. Set up the breathing system with
a test lung. Use the -10 to +80 cm H2O pressure
Examine flowmeters for signs of damage or gauge or meter to measure the airway pressure
abuse (e.g., internal nicks, scratches, cracks, at the test lung. Manually ventilate the test lung
condensation, debris). with the PEEP valve set to deliver 0 cm H2O
water pressure. The end-exhalation pressure in
For each flowmeter, observe the float motion
the breathing system should be less than 1 cm
as the associated valve is turned. The float
H2O, although this depends on the fresh gas flow
should rise and fall freely as the flow is raised or
and APL valve setting.
lowered. At maximum flow, the float should still
be visible at the top of the flow tube. If the PEEP valve is calibrated, set it to deliver
5 and 10 cm H2O water pressure. The pressure
Connect one of the calibrated flowmeters to
in the breathing system at the end of exhalation
the common gas outlet with its discharge di-
should be within 1.5 cm H2O of the set value.
rected into the scavenging or other gas evacu-
ation system. Level the flowmeter. For each gas 3. Preventive maintenance
in turn, set the flow rates at a high and low
setting for each flowmeter that lies within the 3.1 Clean any excess leak-detection solution from
range of the calibrated flowmeter. Record the the exterior and interior of the unit; clean all
readings of both the machine and the calibrated compressed-gas filters, if needed.
flowmeters. Repeat the tests with the second
3.2 Lubricate per the manufacturer’s specifications.
calibrated flowmeter and the second group of
flow rates. 3.4 Replace compressed-gas filters and alarm bat-
teries, if needed.
The readings on the unit’s flowmeters should
agree with those on the calibrated flowmeters to 4. Acceptance tests
within 10% of set values or the manufacturer’s
specifications. If the error is excessive, check for Conduct major inspection tests for this procedure
damaged, inverted, or interchanged flowmeter and the appropriate tests in the General Devices Pro-
tubes, condensation, or damaged floats. cedure/Checklist 438.

2.11 Minimum Oxygen Flow and Percent. The follow- Before returning to use
ing procedure applies to those systems that pro-
Depressurize external gas supply; return all flow-
vide a minimum flow of oxygen or a minimum
meters to zero position; turn all vaporizers to off posi-
percent of oxygen.
tion; and reconnect all tubing (e.g., main common gas
Close the valve to the anesthesia unit’s oxy- outlet tubing). Return all controls to pre-use settings.
gen flowmeter. Connect the 0.1 to 1.0 L/min Attach a Caution tag in a prominent position so the
oxygen flowmeter to the common gas outlet. user is aware that control settings may have been
The flowmeter should read the minimum flow changed.

Inspection and Preventive Maintenance System


©1995 ECRI. All Rights Reserved. 9

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