Maquina Wato EX 20-30-35 Manual de Serv
Maquina Wato EX 20-30-35 Manual de Serv
Maquina Wato EX 20-30-35 Manual de Serv
Machine
Service Manual
Intellectual Property Statement SHENZHEN
MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray)
owns the intellectual property rights to this product and this manual. This manual may refer
to information protected by copyrights or patents and does not convey any license under the
patent rights of Mindray, nor the rights of others. Mindray does not assume any liability
arising out of any infringements of patents or other rights of third parties.
Revision History
This manual has a revision number. This revision number changes whenever the manual is
updated due to software or technical specification change. Contents of this manual are subject
to change without prior notice. Revision 1.0 is the initial release of the document.
© Copyright 2009-2012 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights
reserved.
I
Preface
Manual Purpose
This manual provides detailed information about the assembling, dissembling, testing and
troubleshooting of the equipment to support effective troubleshooting and repair. It is not
intended to be a comprehensive, in-depth explanation of the product architecture or technical
implementation. Observance of the manual is a prerequisite for proper equipment
maintenance and prevents equipment damage and personal injury.
This manual is based on the maximum configuration. Therefore, some contents may not
apply to your monitor. If you have any question, please contact our Customer Service
Department.
Intended Audience
This manual is geared for biomedical engineers, authorized technicians or service
representatives responsible for troubleshooting, repairing and maintaining the anesthesia
machines.
Password
A password is required to access different modes within the anesthesia machine.
II
Contents
1 Safety................................................................................................................................. 1-1
1.1 Safety Information .......................................................................................................... 1-1
1.1.1 Dangers .............................................................................................................. 1-2 1.1.2
Warnings............................................................................................................. 1-2 1.1.3
Cautions ............................................................................................................. 1-2 1.1.4 Notes
.................................................................................................................. 1-3 1.2 Equipment
Symbols ........................................................................................................ 1-3
5 Troubleshooting................................................................................................................ 5-1
5.1 Introduction..................................................................................................................... 5-1
5.2 Technical Alarm Check ................................................................................................... 5-1
5.2.1 Main Unit Related Alarms.................................................................................. 5-1
1 Safety
1.1 Safety Information
DANGER
⌘ Indicates an imminent hazard that, if not avoided, will result in death or serious
injury.
WARNING
⌘ Indicates a potential hazard or unsafe practice that, if not avoided, could result in
death or serious injury.
CAUTION
⌘ Indicates a potential hazard or unsafe practice that, if not avoided, could result in
minor personal injury or product/property damage.
NOTE
⌘ Provides application tips or other useful information to ensure that you get the
most from your product.
1-1
1.1.1 Dangers
There are no dangers that refer to the product in general. Specific “Danger” statements may
be given in the respective sections of this manual.
1.1.2 Warnings
WARNING
⌘ There is high voltage inside the equipment. Never disassemble the equipment
before it is disconnected from the AC power source.
1.1.3 Cautions
CAUTION
⌘ Make sure that no electromagnetic radiation interferes with the performance of the
equipment when preparing to carry out performance tests. Mobile phone, X-ray
equipment or MRI devices are a possible source of interference as they may emit
higher levels of electromagnetic radiation.
⌘ Before connecting the equipment to the power source, check that the power source
conforms to the requirements specified in the Operator’s Manual.
1-2
1.1.4 Notes
NOTE
Equipotential Autoclavable
2 Theory of Operation
2.1 Gas Flow
2.1.1 Pneumatic Circuit Diagram(without 4-yoke configuration)
r
2-1
2.1.2 Parts
List
1 O2 pipeline connector 29 Pressure relief valve (37.9 kPa)
28 Check valve / /
2-2
2.1.3
Pneumatic
Circuit
Diagram(with
4-yoke
configuration)
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2-3
2.1.4 Parts List
1 O2 pipeline connector 31 Inspiratory check valve
2-4
Check valve
2.1.6
Description
2.1.6.1 Gas
Supplies
O2 pipeline supply
inlet
Pressure sampling
connector for pipeline Drive gas
supply pressure gauge connector
Liquid collection bottle
2-5
Regulator
The above picture shows the O2 pipeline supply inlet assembly. The anesthesia machine’s
pneumatic circuit starts from the gas supplies, which functions to introduce the external pipeline or
cylinder gases into the machine. Since the pressure of external gas is very high and the external
gas contains foreign substance, regulator, filters and pressure relief valves are available in the
supply gas circuit. Also, check valves are equipped in the supply gas circuit to prevent gas from
flowing back into the pipeline or cylinder. The following figure shows the supply gas circuit.
2-6
O2 supply Drive gas
O2 flush
The following picture shows the output connectors of O2 pipeline supply inlet assembly.
Regulator (200kPa)
Pressure switch
The following picture shows the output connector of cylinder supply inlet assembly.
Regulator
Pressure sampling
pipeline of N2O
cylinder pressure
Regulator N2O cylinder supply connection
gauge
Pressure sampling
pipeline of O2
cylinder pressure
gauge
O2 cylinder supply
connection
2-8
Machine connection
of N2O cylinder
supply
Pressure sampling
pipeline of N2O
cylinder pressure gauge Machine
connection of O2
cylinder supply
Pressure sampling
pipeline of O2
cylinder pressure
gauge
2-9
2-10
25.O2-N2O
cut-off valve
24. System
switch
Air pipeline supply inlet O2 pipeline supply inlet N2O pipeline supply inlet
assembly assembly assembly
2-11
When system switch 24 is turned on, Air enters flowmeter 26. O2 is divided into two
pathways. One pathway of O2 flows into flowmeter 26 and the other into O2-N2O cut-off
valve 25. If the
pressure of O2
vented into O2-N2O
cut-off valve 25 is
greater than 0.1 MPa,
N2O can enter
flowmeter 26, as
shown below.
O2 tube
26.Flowmeter
N2O tube Air tube
Converged gas
tube
Flowmeter 26 controls gas flows. The gases passing through flowmeter 26 enter the
anesthetic gas delivery system (vaporizer) as shown above.
2-12
The converged gas entering the anesthetic gas delivery device (vaporizer) is mixed with the
anesthetic agent to form fresh gas. The fresh gas then goes from check valve 28 through the
ACGO to the breathing system. The flushed O2 also enters the breathing system through the
ACGO. Regarding anesthesia machine of this configuration, from the system menu select
[Maintenance]→[Factory Maintenance>>]→enter the required password→[System
Setup]. Set [CGO] to [SCGO] in the accessed menu.
From O2 flush to
ACGO
From ACGO to
breathing system
From anesthetic gas
delivery device to ACGO
53. Pressure
relief valve
2-13
The following picture shows the case when a separate ACGO is configured. Regarding
anesthesia machine of this configuration, from the system menu select
[Maintenance]→[Factory Maintenance>>]→enter the required password→[System
Setup>>]. Set [CGO] to [ACGO01] in the accessed menu.
From anesthetic gas
From ACGO to delivery device to
ACGO ACGO
separate outlet
53. Pressure
relief valve
2-14
The following picture shows the case when a separate ACGO (with pressure sampling) is
configured. Regarding anesthesia machine of this configuration, from the system menu select
[Maintenance]→[Factory Maintenance>>]→enter the required password→[System
Setup>>]. Set [CGO] to [ACGO02] in the accessed menu.
Pressure sampling
line
ACGO separate
outlet
When ACGO is turned on, the anesthesia machine stops mechanical ventilation. The fresh
gas is directly outputted through the inspiration connector on the breathing circuit. Pressure
relief valve 53 on the ACGO prevents pressure at the ACGO port from exceeding 110cmH2O
when ACGO is turned on.
2-15
System Switch Assembly
24.System switch
The above picture shows the system switch assembly. Supply gases of Air and O2 go into
system switch 24; and Air & O2 flowing into the flowmeter and O2 into the control end of
the O2-N2O cut-off valve are outputted. System switch has an electrical outlet which controls
the power-on status of the system. When the system switch is turned on, O2 and Air enter the
anesthetic gas delivery system and the system is powered on simultaneously. The anesthetic
ventilator starts to monitor the status of the system. When the system switch is turned off, O2
and Air cannot enter the anesthetic gas delivery system and the system is powered off.
2-16
The O2-N2O cut-off valve assembly involves material switchover. The picture of the latest
real object shall prevail.
The above picture shows the O2-N2O cut-off valve assembly. O2-N2O cut-off valve 25 is a
pneumatically controlled three-way valve. O2 is uploaded to the control end of the O2-N2O
cut-off valve to conduct on-off control of N2O. When the O2 supply pressure is less than 0.1
MPa (approximate value), N2O supply is cut off. When the O2 supply pressure is greater
than 0.1 MPa (approximate value), N2O supply is switched on. O2-N2O cut-off valve 25
does not affect Air supply.
Flowmeter Assembly
26. Flowmeter
The above picture shows the flowmeter assembly. Flowmeter assembly 26 controls O2, N2O
and Air flows and the proportion between O2 and N2O as well to ensure that the gas flows
outputted are adjustable within the range of 0–10 L/min. O2, N2O and Air enter the low-
flow flowmeters and high-flow flowmeters in turn respectively. The low-flow flowmeter
displays flow ranging from 0.05 to 1 L/min at the resolution of 0.05 L/min and the high-flow
flowmeter displays flow ranging from 1.1 to 10 L/min at the resolution of 0.1 L/min. The
flowmeter has integrated an O2-N2O chain linkage which helps keep the O2 concentration
not lower than 21% and keep that the minimum O2 concentration is lower than 40% when
N2O flow exceeds 1 L/min. Turning flow controls counterclockwise increases the flow and
clockwise decreases the flow.
2-17
Vaporizer Manifold
27. Vaporizer
manifold
2-18
The above picture shows the vaporizer manifold assembly. The anesthetic gas delivery device
(vaporizer) is connected to the anesthetic gas delivery system. The mixed gas of N2O, O2
and Air go into the device and the fresh gas containing these three gases and anesthetic agent
is finally outputted to the ACGO assembly. The following figure shows the pneumatic circuit
of anesthetic gas delivery device (vaporizer).
Vaporizer
Double-vaporizer manifold 27 (or single -vaporizer manifold) is integrated with check valve
28 which prevents flushed O2 and fresh gas from flowing back to the vaporizer and impairing
the concentration outputted of the anesthetic agent as a result. When a double-vaporizer
manifold is used, Selectatec mounting with interlocking function can prevent the user from
turning on two vaporizers simultaneously.
ACGO Assembly
30. ACGO
The above picture shows the ACGO assembly. The ACGO assembly includes flow restrictor
21, pressure relief valve 29, ACGO selector switch 54 (three-way valve) and contact switch.
Flushed O2 and fresh gas are mixed and enter the ACGO. The outputs include fresh gas
provided for the breathing system (when ACGO is turned off) and that provided for the
patient (when ACGO is turned on). When ACGO is switched on, the anesthetic ventilator
stops working. Pressure relief valve 29 at the front restricts the pressure of flushed O2 and
also that of the fresh gas not to exceed 38 kPa (approximate value). Pressure relief valve 53 at
the back ensures that the pressure of the gas outputted to the ACGO port does not exceed 110
cmH2O.
2-19
Exhaust
tube
Outputs gas
discharged through
PEEP outlet
The following figure shows the pneumatic circuit of the pneumatically-controlled module.
2-20
Proportional electromagnetic valve 10 controls inlet gas flow. Filter 8 filters drive gas again.
Regulator 9 regulates pressure inside the pneumatic circuit (approximately 0.2 MPa). “11” is
a flow sensor of differential pressure type which monitors gas flow in the drive gas circuit.
Mechanical overpressure valve 12 ensures that the pressure in the drive gas circuit does not
exceed safe pressure. It releases excess gas when gas pressure exceeds 11 kPa. “17” is
expiratory valve. During expiration, gas inside the bellows is discharged from this valve.
The PEEP function is performed through expiratory valve. “16” is low-flow proportional
electromagnetic valve. When it opens, gas is bled from pneumatic resistor 18, forming
relatively stable pressure in the pneumatic circuit between “16” and “18”. Such pressure is
exerted on the membrane of expiratory valve 17 to form PEEP.
To prevent too high pressure inside the pneumatic circuit from injuring the patient and
damaging the equipment, safety valve 14, which is electromagnetic on-off valve, is placed
before the gas pathway of the expiratory valve. “15” is a pressure switch. When drive gas
pressure is less than approximately 140 kPa, an alarm is triggered. Pressure sensor 49
monitors the pressure at which the expiratory valve closes. Pressure relief valve 46 ensures
the tube pressure after the expiratory valve is less than 10 cmH2O.
2-21
conditions of the patient’s expired gas. During inspiration, the drive gas depresses the bag
inside the bellows to force the inside gas to enter the patient’s lungs. During expiration, the
patient’s expired gas goes into the bag inside the bellows. CO2 absorbent canister 32 absorbs
CO2 the patient expires. The following figure shows the pneumatic circuit of breathing
system.
Drive gas
Fresh gas
Manual and mechanical ventilation modes are selected through the Bag/vent switch. When
manual ventilation is selected, the doctor presses manual bag 42 to supply gas for the
breathing system. APL valve 43 adjusts the pressure inside the pneumatic circuit in case of
manual ventilation. When mechanical ventilation is selected, the ventilator starts to work. It
controls the drive gas to depress the bellows 45 and supply gas for the breathing system as
per the selected ventilation mode.
2-22
Connected to the anesthesia machine main unit through the circuit adapter, the breathing
system is highly integrated with impact structure. Its tubes are all built in except the tube
connected to the patient and the O2 cell cable, as shown below.
2-23
In case of mechanical ventilation, during inspiration, gas flows through Bag/vent switch 41, BYPASS
valve 33 or CO2 absorbent canister 32, inspiratory valve 31, O2 sensor 34, and inspiratory flow sensor 36
to the patient. During expiration, gas flows through expiratory flow sensor 38, expiratory valve 40, and
Bag/vent switch 41 to the bellows. Pressure sensor 20 monitors the airway pressure.
The following figure shows the operational theory of the AGSS. The throttling holes reduce the effect of
negative pressure at the AGSS outlet onto the flow at the entrance. The float helps the user to know if the
disposal system meets the requirement for minimum pump rate. The filter filters foreign substance to
prevent the disposal system from being occluded. The gas reservoir is connected to the air through
pressure compensation openings. When positive or negative pressure occurs inside the gas reservoir, gas is
inputted or outputted to ensure pressure balance inside the system.
2-24
There are high-flow and low-flow configurations of AGSS. The declared flow of low-flow
AGSS is 25~50L/min and that of high-flow AGSS is 75~105L/min. The two types of AGSS
configuration have same installation structure and vary in the internal structure only. The
AGSS is mounted onto the anesthesia machine through GCX rail and is fixed by tightening
the hand nut on the GCX rail. Both ends of the transfer hose have 30 mm conical connectors.
The inlet is a female 30 mm conical connector and the outlet a male 30 mm conical connector.
The anesthetic gas receiving system is connected to the receiving hose through CGA V-5
2220 connector. The receiving hose is connected to the hospital’s disposal system through EN
ISO 9170-2:2008 connector (applicable to disposed standard EN 737-4: 1998 connector). To
adapt to the situation that the hospital’s disposal system does not have such standard
connector, the Appendix provides the receiving hose (general) which does not have connector
when connected to the disposal system. Only G1/8 internal thread is provided. You need to
install the appropriate connector based on the hospital’s disposal system before connection.
The following picture shows the AGSS structure and connections.
GCX rail
Transfer hose
Receiving hose (European
standard) To the disposal system
Receiving hose (general)
G1/8 internal thread
2-25
58.
2-26
⌘ After servicing the equipment or replacing its components, complete all the tests in
this section.
⌘ Before doing the tests in this section, completely reassemble the equipment and
refer to 4 Maintenance and Calibration to do necessary calibrations.
⌘ Make sure that the breathing circuit is correctly connected and not damaged.
WARNING
⌘ Do not leave gas cylinder valves open if the pipeline supply is in use. Cylinder
supplies could be depleted, leaving an insufficient reserve supply in case of pipeline
failure.
5. The fixing nuts of the negative pressure suction system are fastened.
6. The gas supplies are connected and the pressures are correct.
7. Cylinder valves are closed on models with cylinder supplies.
8. The casters are not loose and the brake(s) is set and prevents movement.
9. Make sure the circuit is locked safely.
10. The power cord is correctly connected. The AC mains indicator and the battery indicator
work normally.
11. The anesthesia machine is switched on or off normally.
3-1
WARNING
⌘ Do not leave gas cylinder valves open if the pipeline supply is in use. Cylinder
supplies could be depleted, leaving an insufficient reserve supply in case of pipeline
failure.
1. Disconnect the pipeline supplies and close all cylinder valves. Bleed all the gas inside
the machine to let the pressure gauges go to zero. f the gauge fails to go to zero, it
indicates that the gauge is faulty.
2. Connect an O2 pipeline supply.
⌘ After doing the cylinder tests, close all cylinder valves if cylinder supplies are not
used.
⌘ Turn the flow controls slowly. Do not turn further when the flowmeter indicates
the maximum or minimum flow to avoid damaging the control valve.
3-2
1. Set the system switch to the position and connect the cylinders.
2. Open the valve of the cylinder to be checked. Make sure that the valves of other
cylinders are closed.
3. Make sure that the cylinder being checked has sufficient pressure. If not, close the
applicable cylinder valve and install a full cylinder.
4. Close the valve of the checked cylinder.
NOTE
⌘ For N2O test, turn on the O2 supply after the test is completed. Turn off the N2O
main switch first. Turn on the N2O flowmter to ensure that there is no residual N2O
and that the N2O pressure gauge returns to zero. Then turn off the O2 supply.
⓿ If the cylinder pressure for drive gas decreases more than 5000 kPa (725 psi). ⓿
If the cylinder pressure for non-drive gas decreases more than 690 kPa (100 psi).
⓿ In this case, install a new cylinder gasket and repeat steps 1 through 6. If the leak
continues, do not use the system.
8. Repeat 3.3.2 Cylinder High Pressure Leak Test for each cylinder.
NOTE
⌘ Turn the flow controls slowly. Do not turn further when the flowmeter indicates
the maximum or minimum flow to avoid damaging the control valve.
3-3
WARNING
⌘ If N2O is available and flows through the system during this test, use a safe and
approved procedure to collect and remove it.
⌘ Incorrect gas mixtures can cause patient injury. If the O2-N2O Link system does
not supply O2 and N2O in the correct proportions, do not use the system.
4. Connect the AC power source if battery capacity shortage occurs. Do not use the system if
other ventilator failure alarm occurs.
5. Set the flow controls to mid range. Check that the flowtube float moves smoothly.
6. Test the Link system with N2O flow increasing:
a. Turn the O2 and N2O flow controls fully clockwise (minimum flow). b.
Turn the N2O flow control only.
c. Increase the N2O flow gradually as shown in the table. Make sure that the O2 flow
must be greater than the minimum limits.
d. If the N2O flow is set crossing the limit, before continuing the test, turn the O2 flow
control clockwise till the N2O flow decreases to the preset value.
Step N2O flow (L/min) O2 flow (L/min)
1 0.6 ≥0.2
2 1.5 ≥0.5
3 3.0 ≥1.0
4 7.5 ≥2.5
3-4
1 7.5 ≥2.5
2 3.0 ≥1.0
3 1.5 ≥0.5
4 0.6 ≥0.2
8. Cut off the N2O pipeline supply or close the N2O cylinder valve. Turn the O2 and N2O
flow controls counterclockwise respectively and turn on the O2 and N2O flowmeters.
Make sure that there is no residual gas in the N2O pathway and the pressure gauge in the
N2O pathway goes to zero. Then turn the O2 and N2O flow controls clockwise
respectively and make sure that the O2 and N2O flows are at the minimum.
9. Disconnect the O2 pipeline supply or close the O2 cylinder valve.
4. Connect the AC power source if battery capacity shortage occurs. Do not use the system if
other ventilator failure alarm occurs.
5. Set the flow controls to mid range. Check that the flowtube float moves smoothly.
WARNING
⌘ During steps 6 through 7, the O2 sensor used must be correctly calibrated and the
Link system must be kept in working status.
3-5
WARNING
⌘ Use only the Selectatec series vaporizers. Make sure that the vaporizers are locked
when doing the test.
⌘ During the test, the anesthetic agent comes out of the fresh gas outlet. Use a safe
and approved procedure to remove and collect the agent.
⌘ To prevent damage, turn the flow controls fully clockwise (minimum flow or OFF)
before using the system.
Before the test, make sure that the vaporizers are correctly installed.
1. Connect the O2 pipeline supply or open the O2 cylinder valve.
2. Turn the O2 flow control and set the O2 flow to 6 L/min.
3. Make sure that the O2 flow stays constant.
4. Adjust the vaporizer concentration from 0 to 1%. Make sure that the O2 flow must not
decrease more than 1 L/min through the full range. Otherwise, install a different
vaporizer and try this step again. If the problem persists, the malfunction is in the
anesthesia system. Do not use this system.
5. Test each vaporizer as per the steps above.
NOTE
⌘ Do not perform test on the vaporizer when the concentration control is between
“OFF” and the first graduation above “0” (zero) as the amount of anesthetic drug
outputted is very small within this range.
3-6
3.6 O2 Flush Test
3.6.1 In Mechanical Ventilation Mode
1. Connect the O2 pipeline supply or cylinder.
2. Set the Bag/vent switch to the mechanical ventilation position.
3. Set the system switch to the position or set the system to Standby. 4.
Plug the patient connection using a test plug.
5. Turn off ACGO (if ACGO is configured).
6. Let the bellows completely collapse.
7. Press and hold the O2 flush button . Measure the time required for fully inflating
the bellows.
8. Repeat the operation (opening patient connection to collapse the bellows) at least twice. 9.
Check that the bellows is fully inflated within 1 to 3 seconds.
2. Set the system switch to the position or set the system to Standby. 3.
Plug the patient connection using a test plug.
4. Connect a 3 L or 1 L bag to the bag arm or manual bag port.
5. Turn off ACGO (if ACGO is configured).
6. Let the bag completely collapse.
7. Turn the APL valve to 75 cmH2O.
8. Press and hold the O2 flush button . Calculate the time required for the reading on
the pressure gauge to reach 10 cmH2O.
9. Repeat the operation (open patient connection and press the bag to completely collapse
the bag) at least twice.
10. Check that
3-7
3.7 Breathing Circuit Tests
WARNING
⌘ Objects in the breathing circuit can stop gas flow to the patient. This can cause
injury or death. Make sure that there are no test plugs or other objects in the
breathing circuit. Make sure that there are no test plugs or other objects in the
breathing circuit.
⌘ Do not use a test plug that is small enough to fall into the breathing circuit.
1. Make sure that the breathing circuit is correctly connected and not damaged.
2. Make sure that the check valves in the breathing circuit work correctly:
⓿ The inspiratory check valve opens during inspiration and closes at the end of
inspiration, and remains closed during expiration.
⓿ The expiratory check valve opens during expiration and closes at the end of
expiration, and remains closed during inspiration.
5. Push the O2 flush button to fill the bellows, which rises to the top.
6. Make sure that the pressure reading on the airway pressure gauge must not increase to
more than 15 cmH2O
7. Release the O2 flush button and the bellows should not fall. If it falls, it indicates that
the bellows assembly has a leak. You need to reinstall the bellows.
NOTE
⌘ Perform leak test again each time after servicing the anesthesia machine, replacing
the components, or re-connecting the tubes.
⌘ Before performing breathing system leak test, make sure that there is no alarm of
pressure monitoring channel failure on the screen.
3-8
The test aims to check if the pneumatic circuit has leaks in manual ventilation mode. Test
items include APL valve, check valve, sodalime canister, patient tubes, flow sensors and their
connectors.
There are two methods available for breathing system leak test in manual ventilation mode.
One is by software auto test and the other by manual test.
1. Make sure that the system is Standby. If not, press the key and select [Ok] from the
pop-up menu to enter Standby.
2. Set ACGO to patient circuit (if ACGO is configured).
3. Insert the Y piece into the test plug.
4. Install the manual bag.
5. Turn the APL valve to 75 cmH2O.
6. Turn all flow controls to zero.
7. Set the bag/vent switch to the bag position.
8. Push the O2 flush button to let the pressure fall between 25 and 35 cmH2O on the airway
pressure gauge.
9. Select [Continue] to start manual leak test.
10. When the manual leak test is completed, the screen for manual leak test result is
switched to automatically, prompting the manual leak test result.
1. Make sure that the system is Standby. If not, press the key and select [Ok] from the
pop-up menu to enter Standby.
2. Set ACGO to patient circuit (if ACGO is configured).
3. Set the bag/vent switch to the bag position.
4. Connect the manual bag to the manual bag port.
5. Turn the APL valve control to fully close the APL valve (75 cmH2O).
6. Turn the O2 flow control to set the O2 flow to 0.15 to 0.2 L/min.
7. Close the breathing system at the patient connection.
8. Push the O2 flush button to let the pressure increase to approximately 30 cmH2O on the
airway pressure gauge.
9. Release the O2 flush button. A pressure decrease on the airway pressure gauge indicates a
leak. Look for and repair the breathing system leak.
Software auto leak test 1. The reading on the drive gas Replace or connect gas
is failed. pressure gauge indicates drive supplies and make sure that
gas pressure low (lower than the drive gas pressure is at
200 kPa) and the alarm of 280 to 600 kPa.
[Drive Gas Pressure Low] is
produced.
5 The airway pressure The zero point of airway pressure sensor 0000 0010
sensor has an error. is not within the range of 0~1200(AD).
6 The airway pressure is Before the test, the airway pressure in the 0000 0020
not sufficient. circuit is less than 18cmH2O
7 Pressure drops drastically. Pressure drops by more than 10cmH2O. 0000 0040
NOTE
⌘ If there is indeed a leak, check the pneumatic circuit system for leakage and
troubleshoot the problems as described in 5.3Pneumatic Circuit System Problems.
⌘ After leak failure is troubleshot, do the leak test again and make sure the test is
passed.
Mode
NOTE
⌘ Perform leak test again each time after servicing the anesthesia machine, replacing
the components, or re-connecting the tubes.
The test aims to check if the pneumatic circuit has leaks in mechanical ventilation mode. Test
items include bellows, drive gas circuit, CO2 absorbent canister, patient tubes, flow sensors
and their connectors.
3-11
NOTE
⌘ Breathing circuit leak test must be performed when the system is Standby.
⌘ Before doing the breathing circuit leak test, make sure that the breathing circuit is
correctly connected and the breathing tubes not damaged.
⌘ Before doing the breathing system leak test, make sure that the drive gas pressure
is sufficient and the screen does not have alarms of flow sensor failure or pressure
monitoring channel failure. During the leak test, make sure that the test
procedures are strictly followed.
⌘ During the leak test, selecting [Cancel] will stop the ongoing leak test. To continue
the test, you must select [Continue] to start the leak test again.
1. Make sure that the system is Standby. If not, press the key and select [Ok] from the
pop-up menu to enter Standby.
2. Set ACGO to patient circuit (if ACGO is configured).
3. Connect the Y piece on the breathing tube to the leak test plug to occlude the outlet of Y
piece.
4. Turn all flow controls to zero.
3-12
5) If the tube compliance is displayed in green numerics, it indicates that the tube
compliance measured value is within the reasonable range. If tube compliance
measurement is failed because the leakage exceeds 200 ml/min or due to other reason,
the failure message is displayed directly.
9. If the leak test is passed, it indicates that leakage of mechanical ventilation circuit is
within 0.2 L/min and the system has good airtightness. If the leak test is failed, it
indicates that the leakage of mechanical ventilation circuit exceeds 0.2 L/min and the
leak test screen prompts the user to do the following checking:
1) If the Y-shaped tube is sealed;
2) If the bellows rises to the top of the bellows housing;
3) If the O2 sensor is installed;
4) If the sampling port is occluded;
5) Select Retry to do the test again and select Override to enter Standby.
Check following the above steps. Select Retry to do the test again. If the leak test is still
failed, overhaul the machine.
NOTE
⌘ In case of leak test failure, check all of the possible leak sources, including bellows,
breathing system tubes and CO2 absorbent canister. Check that they are correctly
connected and their connectors are not damaged.
⌘ If there is indeed a leak, check the pneumatic circuit system for leakage and
troubleshoot the problems as described in 5.3Pneumatic Circuit System Problems.
⌘ After leak failure is troubleshot, do the leak test again and make sure the test is
passed.
3-13
Leak test failure is The bag/vent switch is set to Set the bag/vent switch to the
prompted the bag position and the mechanical ventilation
immediately after message [Manual Vent.] is position.
[Start] is selected prompted.
(typically, the leak
test requires at least The reading on the drive gas Replace or connect gas
3 (O2) pressure gauge indicates supplies and make sure that
minutes). drive gas pressure low (lower the drive gas pressure is at
than 200 kPa) and the alarm of 280 to 600 kPa.
[Drive Gas
Pressure Low] is produced.
The airway pressure Fresh gas is not turned off. Turn off the fresh gas.
does not drop during
the test but test failure
is
prompted.
During leak test, the 1. Before the leak test, the Check the pneumatic
pressure indicated by bellows is not fully inflated. connections and re-install the
the airway pressure 2. The Y piece on the pneumatic circuit.
gauge fails to reach 30 breathing tube is not
cmH2O. connected to the test plug.
3. The bellows housing is
not properly installed.
4. The CO2 absorbent canister
is not installed in place.
During leak test, the 1. The bellows housing may not Check the pneumatic
pressure indicated by be installed properly. connections and re-install the
the airway pressure 2. The expiratory valve pneumatic circuit.
gauge reaches 30 assembly is leaky.
cmH2O but then falls 3. The circuit is not tightly
rapidly. connected to the circuit adapter.
4. The connection between the
sampling line of the sensor and
the board is leaky.
After the leak test, Control of safety valve by Restart the machine. Verify if
the alarm of the auxiliary control board the safety valve is controllable
[Ventilator fails. by using the safety valve
Hardware Error control command of the
11] occurs. monitor board.
3-14
After the leak test, Control of safety valve by If the safety valve is damaged,
the alarm of [PEEP the monitor board fails. replace the safety valve. If the
Safety Valve safety valve is in good
Failure] occurs. condition, it indicates that the
auxiliary control board or the
main control board is faulty
regarding the control path of
the safety valve. Check the
connecting lines or replace the
faulty board.
5 The airway pressure The zero point of airway pressure sensor 0000 0010
sensor has an error. is not within the range of 0~1200(AD).
3-15
NOTE
⌘ In case of leak test failure, check the machine for leakage and roughly assess the
amount of leakage by using the following methods.
⓿ Method 1: In the default VCV mode, stop fresh gas supply. If the bellows rises to the
top each time, it indicates that the machine is not leaky. Otherwise, the machine is
leaky. Gradually increase fresh gas. The amount of fresh gas when the bag rises to the
top at each expiration can be roughly calculated as the amount of leakage.
⓿ Method 2: During leak test, observe the airway pressure gauge. A period of time
(about 30 s) belongs to pressure holding stage after the airway pressure rises. If the
airway pressure gauge shows that airway pressure is gradually falling, it indicates that
the machine is leaky. Slowly increase fresh gas until airway pressure stops falling. The
amount of the then fresh gas can be calculated as amount of leakage.
⌘ If there is indeed a leak, check the pneumatic circuit system for leakage and
troubleshoot the problems as described in 5.3Pneumatic Circuit System Problems.
⌘ After leak failure is troubleshot, do the leak test again and make sure the test is
passed.
1. Make sure that the system is Standby. If not, press the key and select [Ok] from the
pop-up menu to enter Standby.
2. Set the Bag/vent switch to the bag position.
3. Connect the manual bag to the manual bag port.
4. Connect the Y piece on the breathing tube to the leak test plug on the manual bag port. 5.
Turn the APL valve control to let the pressure of APL valve stay at 30 cmH2O. 6. Push the
O2 flush button to inflate the manual bag.
7. Make sure that the reading on the airway pressure gauge is with the range of 25 to 35
cmH2O.
8. Turn the APL valve control to the SP position.
3-16
④ Y piece (quantity:1)
Test procedures:
1. Turn the system switch off. Close all flow regulators. Turn on ACGO. 2. Pull out the patient circuit.
Mount the circuit adapter test fixture onto the circuit adapter.
3. Connect the pressure sensor connector (positive pressure end) on the anesthesia machine calibration
device and the injector (before mounting, pull out the push rod of the injector to the graduation of 100 ml)
connector to two connectors of the Y piece through twoΦ6 silicone tubes. Connect the third connector of
the Y piece to No.8 connector on the
circuit adapter test fixture through the PU tube (6X300), as shown below.
3-17
4. Push in the push rod of the injector to cause the pressure reading on the anesthesia machine
calibration device to rise slowly (note to push in the rod at uniform and slow velocity to
control the time required for the pressure reading to slowly rise to 100 cmH2O more
than 10 s). Continue pushing the push rod at uniform velocity until the rod stops. During
the course of pushing in the injector’s push rod, the pressure reading on the anesthesia
machine calibration device tends to be stable after the tested pressure relief valve is
opened. The pressure reading on the anesthesia machine calibration device after the
tested pressure relief valve is open should be within 100 to 125 cmH2O. Otherwise, the
test is failed. In this case, you need to replace the pressure relief valve assembly (BOM
number: 0621-30-69662).
⓿ [Rate]:12 BPM.
⓿ [I:E]: 1:2.
⓿ [Plimit]: 30 cmH2O.
⓿ [PEEP]: OFF.
⓿ [TIP:TI]: OFF.
6. Push the O2 flush button to fill the bellows, which rises to the top.
7. Turn the O2 flow control to set the O2 flow to 0.5 to 1 L/min.
8 Press the key and select [Ok] from the pop-up menu to exit Standby. 9.
Make sure that:
3-18
2. Remove the O2 sensor and make sure that the sensor measures approximately 21% O2 in
room air.
3. Select [Alarm Setup] and then [Ventilator >>]. Set the FiO2 low alarm limit to 50%. 4.
Make sure that a low FiO2 alarm occurs.
5. Set the FiO2 low alarm limit to a value less than the measured FiO2 value and make sure
that the alarm cancels.
6. Put the O2 sensor back in the circuit.
7. Select [Alarm Setup] and then [Ventilator >>]. Set the FiO2 high alarm limit to 50%.
8. Connect the manual bag to the manual bag port. Push the O2 flush button to fill the
manual bag. After two to three minutes, make sure that the sensor measures
approximately 100% O2.
9. Make sure that a high FiO2 alarm occurs.
10. Set the FiO2 high alarm limit to 100% and make sure that the alarm cancels.
3.9.3 Test the Low Minute Volume (MV) Alarm
1. Make sure that MV alarm is turned on.
2. Select [Alarm Setup] and then [Ventilator >>]. Set the MV low alarm limit to 8.0
L/min.
3. Make sure that a low MV alarm occurs.
4. Select [Alarm Setup] and then [Ventilator >>]. Set the MV low alarm limit to the
default.
3-19
3. Turn the APL valve control to set the APL valve to the minimum position. 4.
Inflate the manual bag to make sure that a complete breathing cycle occurs.
5. Stop inflating the manual bag and wait for at least 20 seconds to make sure that the
apnea alarm occurs.
6. Inflate the manual bag to make sure that the alarm cancels.
5. Push the O2 flush button for approximately 15 seconds. Make sure that the sustained
airway pressure alarm occurs.
6. Open the patient connection and make sure that the alarm cancels.
3.9.6 Test the High Paw Alarm
3-20
NOTE
⌘ Do not block the AGSS pressure compensation openings during the inspection.
3-21
a. Turn the top cover counterclockwise to separate it from the sight glass. Remove the
filter screen.
b. Shake dust and foreign substance from the removed filter screen until satisfactory
clean effect is achieved.
3. The waste gas disposal system is not working or the pump rate is less than the AGSS
normal working flow. Check if the waste gas disposal system reaches the pump rate
range which the AGSS declares, which is 25 to 50 L/min for low flow AGSS and 75 to
105 L/min for high flow AGSS.
3-22
3. Unplug the power cord with the system turned on. The message [Battery in Use] is
displayed. Meanwhile, the AC power LED is extinguished.
4. Reconnect the AC power. The prompt message disappears. The AC power LED is
illuminated.
3-24
⓿ normal polarity;
⓿ reverse polarity;
4. Verify the maximum leakage current does not exceed 500 μA (0.5 mA) in the first two
tests. While for the last two tests, verify that the maximum leakage current does not
exceed 1000 μA (1 mA).
3-25
NOTE
⌘ Make sure the safety analyzer is authorized by certificate organizations (UL, CSA,
or AMAI etc.). Follow the instructions of the analyzer manufacturer.
3-26
⌘ When it comes to test and maintain the equipment, make sure that the patient is
disconnected from the equipment.
⌘ The equipment may have been used on patients carrying infectious diseases. Before
testing or maintaining the equipment, wear sterile rubber gloves to reduce the risk
of being infected.
NOTE
⌘ These schedules are the minimum frequency based on typical usage of 2000 hours
per year. You should service the equipment more frequently if you use it more than
the typical yearly usage.
⌘ To avoid equipment damage or personal injury, replace the parts which need to be
replaced periodically even if they are not worn or damaged when the due date
arrives.
4-1
15 049-000049-00 Bellows 1
4-2
Filter (0611-20-45600)
4-3
Seals to be replaced
3. As required, replace the seal for valve cover (M6M-010031--) and valve seal
(M6M-010033---) every 12 months.
Seal (M6M-010031---)
Seal (M6M-010033---)
4-4
4. As required, replace the seal for water collection cup (M6M-010038---) every 12
months.
S
eal (M6M-010038---)
4-5
For WATO EX-20 anesthesia machine, replace the sealing component for CO2 absorbent
canister outlet (049-000415-00), sealing cushion for CO2 absorbent canister (049-
000416-00) and sealing cushion for adapter plate (049-000422-00).
Sealing cushion for adapter Sealing cushion for CO2 Sealing component for CO2
plate absorbent canister (049-000416- absorbent canister outlet (049-
(049-000422-00) 00) 000415-00)
6. For WATO EX-25/30/35 anesthesia machine, as required, replace the seal for CO2
absorbent canister support (M6M-010051--) every 12 months.
Seal (M6M-010051--)
4-6
For WATO EX-20 anesthesia machine, replace the seal for CO2 absorbent canister
support (M6M-010051--) every 12 months.
Seal
(M6M-010051--)
7. As required, replace the seal for pressure sampling connector (M6M-010063---), seal for
fresh gas and ACGO (M6M-010006---), seal for drive gas and APL discharge (M6M-
010058---) every 12 months.
4-7
8. As required, replace
the seal for
bellows housing
(0601-20-78848)
and bellows
(0601-10-69901)
every 12 months.
Bellows
(0601-10-69901)
9. As required, replace the seal for axis of Bag/vent switch (0030-10-13077) every 12
months. For details, refer to 6Repair and Disassembly.
Screws to be unscrewed
Pin axis pulled out
Pull out the pin axis after
removing the seal herein
Seal (0030-
10-13077))
4-9
10. For WATO EX-25/30/35 anesthesia machine, as required, replace the BYPASS large
sealing cushion (0601-20-78840) every 12 months. If the BYPASS large sealing cushion
needs to be replaced, apply threadlocker Loctite® 243(A90-000060---) to the threads of
the ByPASS positioning post (0601-20-78821 ) when a new BYPASS large sealing
cushion is to be assembled. For WATO EX-20 anesthesia machine, this step is not
required.
ByPASS
positioning post
(0601-20-78821)
*
BYPASS large sealing
cushion (0601-20-78840)
4-10
4-11
4 Check Check if the zero points of all the flow sensors and After each
the pressure sensors inside the machine are within the service or at
sensors’ normal range so as to determine when to replace the the time of
zero points monitor board. return
visit
NOTE
NOTE
⓿ TV control and measurement are normal: the displayed TVe value should be within
the range of TV setting X (1±10%) ml.
⓿ Circuit leak is within the acceptable range: the bellows can reach the top of the
bellows housing each time and the lowest graduation on the bellows housing which
the bellows falls to each time corresponds to approximately TV setting.
⓿ Pressure measurement is normal: the Ppeak measured value is close to the peak
pressure reading on the airway pressure gauge. The error should not exceed 2
cmH2O.
⓿ No other ventilation failure occurs: the Paw and flow waveforms are displayed
normally and no technical alarms occur.
If the above test requirements are not met, perform subsequent checks and do the test again.
NOTE
⌘ If any errors are detected during the ventilation test, perform troubleshooting as
per 5 Troubleshooting and do the test again until the system is normal.
4-13
NOTE
⌘ Pressure control ventilation is one of the basic mechanical ventilation modes of the
anesthesia machine. It is configured depending on user selection and machine type.
If the anesthesia machine under test is not configured with this mode, this test is
not required.
⓿ Pressure control and measurement are normal: the displayed Ppeak value should be
within the range of Pinsp setting ±2 cmH2O.
⓿ Circuit leak is within the acceptable range: the bellows can reach the top of the
bellows housing each time.
⓿ Pressure measurement is normal: in one breathing cycle, the Ppeak measured value
should be close to the maximum reading on the airway pressure gauge (with error not
exceeding 2 cmH2O) and the displayed PEEP value close to the minimum reading on
the airway pressure gauge (with error not exceeding 1 cmH2O).
⓿ No other ventilation failure occurs: the Paw and flow waveforms are displayed
normally and no technical alarms occur.
If the above test requirements are not met, perform subsequent checks and do the test again.
NOTE
⌘ If any errors are detected during the ventilation test, perform subsequent checks
and do the test again until the system is normal.
4-14
Mode
For details, refer to 3.7.3Breathing System Leak Test in Mechanical Ventilation Mode.
NOTE
⌘ The zero point A/D value of the airway pressure sensor and PEEP pressure sensor
should fall within the normal range of 400 to 800.
⌘ The zero point A/D value of the inspiratory flow sensor, expiratory flow sensor and
built-in ventilator flow sensor should fall within the normal range of 50 to 1800.
⌘ If the zero point of the pressure sensor has an error, in ventilation status, the
baseline of the Paw waveform is not at the zero point and a great deviation occurs
between pressure control and measurement.
⌘ If the zero point A/D value of any sensor is outside of the normal range, it cannot
be corrected. The monitor board must be replaced.
NOTE