& New Zealand College of Anaesthetists Recommendations on Checking
Anaesthesia Delivery Systems With Hyperlinks to Reusable Simulation Learning
Objects for 1993 FDA Checkout
Hyperlinks start at section 4.2.2. Scroll
An anaesthesia delivery system includes any machine, equipment or apparatus
which supplies gases, vapours, local anaesthesia and/or intravenous
anaesthesia agents in order to safely and reliably induce and maintain
2.1 Anaesthesia delivery systems must be serviced at regular and specified
2.2 The Hospital, Anaesthesia Department or body responsible for the
equipment shall keep a detailed record of the service requirements for
all anaesthesia delivery systems. These requirements will be based on
appropriate Australian or New Zealand Standards, manufacturer's guidelines,
and Biomedical Engineering and Anaesthesia Department recommendations.
They shall describe calibration protocols and the intervals at which
these must be performed.
2.3 A prominent label that is visible to the anaesthetist must be attached
to all anaesthesia delivery systems to advise of past service(s) and
to indicate when the next service is due.
2.4 To ensure early detection of any failure in an anaesthesia delivery
system, appropriate alarms must be present, and patient monitoring as
specified in College Professional Document PS18 - Recommendations on
Monitoring During Anaesthesia must be provided.
2.5 There must be a secondary facility to maintain oxygenation and ventilation
of the patient should failure of the primary systems occur.
3. CHECKING ANAESTHESIA DELIVERY SYSTEMS
3.1 Every anaesthesia delivery system must be checked before use to
ensure that it will function correctly. This document requires three
different levels of checks:
3.1.1 Level One check. This is very detailed and is required a) on any
new system and b) on all systems after servicing. This check will usually
be performed by the service person - whether from the equipment provider,
or from the Biomedical Engineering Department.
3.1.2 Level Two check. This should be performed at the start of each
3.1.3 Level Three check. This should be performed immediately before
commencing each anaesthetic.
3.2 The Anaesthesia Department is responsible for:
3.2.1 Defining minimum requirements for each check in accordance with
section 4. These must be appropriate for the specific system under test.
3.2.2 Attaching these check-lists to each anaesthesia delivery system
3.2.3 Training and accreditation of the personnel involved with each
check as follows:
126.96.36.199 Level One. Attendance at a manufacturer's course or a programme
developed by the hospital's Anaesthesia Department in consultation with
a qualified Biomedical Engineer.
188.8.131.52 Levels Two and Three. All Anaesthesia Department personnel must
be trained and accredited in correct anaesthesia system checking procedures.
4.1 Level One check. This must be performed by a suitably qualified
person (usually the service provider) on all anaesthesia delivery systems
a) before they enter service and b) following servicing. The check shall
4.1.1 Gas Delivery Devices.
184.108.40.206 Quantifying and minimising leaks
220.127.116.11 Excluding crossed pipelines within the anaesthesia delivery
18.104.22.168 Ascertaining the correct functioning of non-return valves throughout
22.214.171.124 Ascertaining the integrity of oxygen failure prevention and
126.96.36.199 Checking the composition of delivered gases and their flowrate
4.1.2 Inhalational Anaesthesia Devices
188.8.131.52 Ascertaining that no leakage occurs
184.108.40.206 Checking any thermostat function
220.127.116.11 Calibrating output at both high and low flow rates
18.104.22.168 Checking function of any interlocking or other mechanisms
4.1.3 Intravenous and Local Anaesthesia Delivery Devices
22.214.171.124 Checking electrical safety
126.96.36.199 Calibrating output rate and accuracy
188.8.131.52 Calibrating occlusion pressure
184.108.40.206 Checking alarm function and accuracy
220.127.116.11 Ensuring operation of all user functions and parameters
18.104.22.168 Checking serviced mechanisms operate correctly
22.214.171.124 Checking battery performance
4.1.4 Other Equipment. The check should include the function, safety
and accuracy of any other equipment included within the delivery system
(such as to provide for ventilation, scavenging and monitoring).
4.1.5 The check shall verify that the system as supplied complies with
the relevant Australian or New Zealand Standards.
4.1.6 Documentation of the check is required and shall include the date,
what was checked, the results of the check, and who performed the check
4.2 Level Two check. This check is the responsibility of the anaesthetist
but may be undertaken by a suitably qualified person (such as an appropriately
trained nurse or technician) in accordance with a protocol specific
for the particular system at least at the beginning of each session.
Thus several different protocols may be required in a single hospital.
These will serve to verify the correct functioning of the anaesthesia
delivery system before it is used for patient care.
Not all the following checks may be appropriate in some self-checking
4.2.1 Service label. Confirm that the device has been appropriately
serviced and is not past its service date
4.2.2 High Pressure System.
oxygen cylinder supply. Ensure that cylinder content is sufficient
for its intended purpose.
that piped gas supplies (where present) are at the specified pressures
and that after completing the high pressure system checks, the
cylinders are turned off.
126.96.36.199 To confirm that pipeline gas supplies are not crossed, use a
multi-gas analyser to check gas composition at the common gas outlet,
the inspiratory limb or the Y-piece.
4.2.3 Low Pressure System.
flow controls. Turn on each gas and observe the appropriate operation
of the corresponding flow indicator. Verify the functioning
of the anti-hypoxic device.
188.8.131.52 If vaporiser/s are present:
that adequate anaesthetic liquid is present.
184.108.40.206.2 Ensure that the vaporiser filling ports are closed.
220.127.116.11.3 Check correct seating and locking of a detachable vaporiser.
18.104.22.168.4 Test for circuit leaks for each vaporiser in both on
positions. - steps 5a,
in 1993 FDA pre-use check
22.214.171.124.5 Ensure power is available for electrically operated vaporisers.
126.96.36.199 Check for pre-circuit leaks using a protocol appropriate for
the specific anaesthesia delivery system.
188.8.131.52 Breathing systems. Inspect and check the breathing system to
ensure correct assembly and absence of leaks. The precise protocol will
depend on the anaesthesia circuit to be used.
184.108.40.206.1 Perform leak test on the breathing system by occluding the
patient and rebreathing bag connections, setting a fresh gas flow of
300 ml/min and ensure that the pressure rises to >30 cm H2O from
220.127.116.11.2 For circle systems, inspect the integrity of the system, its
connections and check
the unidirectional valves. This can be accomplished with a breathing
bag on the patient limb of the Y-piece. Ventilate
the system manually using an appropriate fresh gas flow. Observe inflation
and deflation of the attached breathing bag and check for normal system
resistance and compliance. Observe
movement of any visible unidirectional valves. Check function of
adjustable pressure limiting (APL) valve by ensuring easy gas spill
through APL when the two breathing bags are squeezed.
If a carbon dioxide absorber is present, check the colour of the carbon
dioxide absorbent. If the absorbent may have dried out by prolonged
dry gas flow then it should be replaced in order to avoid the potential
for production of carbon monoxide.
4.2.4 Automatic Ventilation System. This should be checked according
to the manufacturer's recommendations. A
test lung (such as a suitably compliant bag) may be used to check the
function of the ventilator and the delivery of adequate tidal volume.
If a test lung is used, the fresh gas flow should be set to zero, or
minimal flow, to help detect leaks in the ventilator. Correct function
of disconnection and high pressure alarms and the high pressure relief
valve if present should be checked at this time. - see steps 12a,
of the 1993 FDA pre-use check
4.2.5 Scavenging System. Check
that the scavenging system is properly connected, the scavenging
suction flow is adjusted appropriately and that the scavenging outlet
is not blocked. This should be checked after connection to the APL valve
and appropriate adjustment of the scavenging gas flow. With
the patient outlet occluded and the APL valve open, a full breathing
system should not normally empty. If
emptying does occur, the absence of negative pressure in the circuit
system should be confirmed.
4.2.6 Emergency Ventilation System. Verify
the presence and functioning of an alternative method of providing oxygen
and of controlled ventilation (such as a self-inflating bag).
4.2.7 Intravenous and Local Anaesthesia Delivery Devices. These should
be checked according to the manufacturer's recommendation and should
18.104.22.168 The device is appropriate for the intended function with special
attention to its range of flow rate and occlusion pressure
22.214.171.124 The anaesthetic is correctly loaded and labelled
126.96.36.199 Any program is correct with special attention to:
188.8.131.52.1 Syringe/container type and volume
184.108.40.206.2 Anaesthetic concentration
220.127.116.11.3 Flow rate and units
18.104.22.168.4 Any alarm parameters
22.214.171.124 The device is appropriately powered by mains and/or batteries
126.96.36.199 All connections to the device and onto the patient are secure
188.8.131.52 There is no leakage
184.108.40.206 The device actually functions and the drug is delivered.
220.127.116.11 An anti-reflux valve is installed if sharing a delivery line.
4.2.8 Other apparatus to be used. This should be checked according to
specified protocols. Attention should be given to:
18.104.22.168 Equipment used for airway maintenance and intubation of the
22.214.171.124 Suction apparatus.
126.96.36.199 Gas analysis devices.
188.8.131.52 Monitoring equipment. Special attention should be paid to alarm
limits and any necessary calibration.
184.108.40.206 Intravenous infusion devices.
220.127.116.11 Devices to mimimise hypothermia during anaesthesia.
18.104.22.168 Breathing circuit humidifiers.
22.214.171.124 Breathing circuit filters.
4.2.9 Final check. Ensure vaporisers are turned off and that the breathing
system is purged with air or oxygen as appropriate.
4.2.10 Documentation of the completion of the check is recommended.
4.3 Level Three check. Immediately before commencement of each anaesthetic,
the anaesthetist should:
4.3.1 Check a changed vaporiser using the protocol outlined in 126.96.36.199.
4.3.2 Check a changed breathing circuit using the protocol outlined
4.3.3 Check any intravenous or local anaesthesia devices using the protocol
outlined in 4.2.7
4.3.4 Check other apparatus as specified in 4.2.8