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Maquina Wato EX 20-30-35 Manual de Serv

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WATO EX-20/30/35 Anesthesia

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.

Mindray intends to maintain the contents of this manual as confidential information.


Disclosure of the information in this manual in any manner whatsoever without the written
permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution,
rent, adaption and translation of this manual in any manner whatsoever without the written
permission of Mindray is strictly forbidden.

, , and WATO are the registered trademarks or trademarks


owned by Mindray in China and other countries. All other trademarks that appear in this
manual are used only for editorial purposes without the intention of improperly using them.
They are the property of their respective owners.

Contents of this manual are subject to changes without prior notice.

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.

④ Revision number: 6.0

④ Release time: 2012-11

© 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.

④ Manage Configuration: 1234

④ Factory maintenance: 0611

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

2 Theory of Operation ........................................................................................................ 2-1


2.1 Gas Flow ......................................................................................................................... 2-1
2.1.1 Pneumatic Circuit Diagram(without 4-yoke configuration)............................... 2-1 2.1.2
Parts List ............................................................................................................ 2-2 2.1.3
Pneumatic Circuit Diagram(with 4-yoke configuration).................................... 2-3 2.1.4 Parts
List ............................................................................................................ 2-4 2.1.5 Key to
Symbols.................................................................................................. 2-5 2.1.6
Description ......................................................................................................... 2-5

3 Checkout and Test............................................................................................................ 3-1


3.1 System Inspection ........................................................................................................... 3-1
3.2 Pipeline Tests .................................................................................................................. 3-2
3.3 Cylinder Tests.................................................................................................................. 3-2
3.3.1 Check the Cylinders are Full.............................................................................. 3-3 3.3.2
Cylinder High Pressure Leak Test...................................................................... 3-3 3.4 Flow
Control System Tests ............................................................................................. 3-3 3.4.1
Without O2 Sensor ............................................................................................. 3-3 3.4.2 With
O2 Sensor .................................................................................................. 3-5 3.5 Vaporizer
Back Pressure Test .......................................................................................... 3-6 3.6 O2 Flush
Test .................................................................................................................. 3-7 3.6.1 In
Mechanical Ventilation Mode ........................................................................ 3-7 3.6.2 In
Manual Ventilation Mode .............................................................................. 3-7 3.7 Breathing
Circuit Tests.................................................................................................... 3-8 3.7.1 Bellows
Test ....................................................................................................... 3-8 3.7.2 Breathing
System Leak Test in Manual Ventilation Mode................................. 3-8 3.7.3 Breathing
System Leak Test in Mechanical Ventilation Mode .........................3-11 3.7.4 APL Valve
Test................................................................................................. 3-16 3.8 Pressure Relief
Valve Test............................................................................................. 3-17 3.9 Alarm
Tests.................................................................................................................... 3-18 3.9.1
Prepare for Alarm Tests.................................................................................... 3-18 3.9.2 Test
the O2 Concentration Monitoring and Alarms .......................................... 3-19 3.9.3 Test the
Low Minute Volume (MV) Alarm ...................................................... 3-19

3.9.4 Test the Apnea Alarm ....................................................................................... 3-20


3.9.5 Test the Sustained Airway Pressure Alarm....................................................... 3-20
3.9.6 Test the High Paw Alarm.................................................................................. 3-20
3.9.7 Test the Low Paw Alarm .................................................................................. 3-21
3.10 AGSS Inspection ......................................................................................................... 3-21
3.10.1 Check the Float .............................................................................................. 3-21
3.10.2 Check the Transfer Tube and Active Scavenging Tube.................................. 3-22
3.11 Negative Pressure Suction Inspection ......................................................................... 3-23
3.11.1 Check the Tube Connections of Liquid Collection Bottle.............................. 3-23
3.11.2 Check the Negative Pressure.......................................................................... 3-24
3.12 Power Failure Test....................................................................................................... 3-24
3.13 Electrical Safety Inspection......................................................................................... 3-25
3.13.1 Auxiliary Electrical Outlet Test...................................................................... 3-25
3.13.2 Electrical Safety Inspection Test .................................................................... 3-25
3.13.3 Electrical Safety Inspection Form .................................................................. 3-26

4 Maintenance and Calibration ......................................................................................... 4-1


4.1 Equipment Maintenance.................................................................................................. 4-1
4.1.1 One-year Replaceable Parts ............................................................................... 4-2 4.1.2
Three-year Replaceable Parts............................................................................4-11 4.2 System
Test ....................................................................................................................4-11 4.2.1
Check the Mechanical Ventilation Mode ......................................................... 4-12 4.2.2
Breathing System Leak Test in Mechanical Ventilation Mode ........................ 4-15 4.2.3
Breathing System Leak Test in Manual Ventilation Mode............................... 4-15 4.2.4
Check the Sensor Zero Point............................................................................ 4-15 4.2.5
Check the Flow Sensor Accuracy..................................................................... 4-16 4.2.6
Check the Pressure Sensor Accuracy ............................................................... 4-17 4.3 System
Calibration........................................................................................................ 4-18 4.3.1 Flow
Calibration (user) .................................................................................... 4-19 4.3.2 Flow
Calibration (factory)................................................................................ 4-20 4.3.3 Pressure
Calibration (factory) .......................................................................... 4-29 4.3.4 Pressure and
Flow Zeroing (factory)................................................................ 4-34 4.3.5 O2 Sensor
Calibration (optional) ..................................................................... 4-35 4.3.6 CO2 Calibration
(factory) ................................................................................ 4-36 4.4 Software Upgrade and
Software Configuration Activation........................................... 4-38 4.4.1 Software
Upgrade............................................................................................. 4-38 4.4.2 Software
Function Activation........................................................................... 4-46 4.4.3 Load O2
Sensor Monitoring Function.............................................................. 4-51 4.5 Adjust the APL
Valve Accuracy .................................................................................... 4-52

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

5.2.2 Auxiliary Control Module Related Alarms ........................................................ 5-


7 5.2.3 CO2 Module Related Alarms .............................................................................
5-7 5.2.4 Heating Module Related Alarms .......................................................................
5-9
5.3 Pneumatic Circuit System Problems ............................................................................. 5-
10 5.3.1 Tools for on-site Maintenance..........................................................................
5-10 5.3.2 Gas Supplies and Drive Gas.............................................................................
5-19 5.3.3 Anesthetic Gas Delivery System......................................................................
5-28 5.3.4 Patient Circuit...................................................................................................
5-39 5.3.5 Tidal Volume
Inaccuracy.................................................................................. 5-56
5.4 Troubleshoot Sensor and Valve Related Failures by Using the Valves-test Tool .......... 5-
58 5.4.1 Preparations before Using the Valves-test Tool................................................ 5-58
5.4.2 One-to-one Correspondence between the Sensors & Valves on the Valves-test Tool
Screen and the Components.............................................................................. 5-59 5.4.3
Description ....................................................................................................... 5-60 5.5
Hardware and Electrical Problems................................................................................ 5-65

6 Repair and Disassembly .................................................................................................. 6-1


6.1 Prepare for Disassembly ................................................................................................. 6-2
6.1.1 Tools................................................................................................................... 6-2 6.1.2
Preparations........................................................................................................ 6-2 6.1.3 Bleed
Gas Pressure............................................................................................. 6-3 6.2 Disassemble
the Assemblies ........................................................................................... 6-3 6.2.1 Remove
the Top Plate Assembly........................................................................ 6-3 6.2.2 Remove the
Table Toplight Board...................................................................... 6-4 6.2.3 Remove the
Upper Rear Plate ............................................................................ 6-5 6.2.4 Remove the
Lower Rear Plate............................................................................ 6-6 6.2.5 Disassemble the
Heating Control Box Assembly............................................... 6-6 6.2.6 Replace the
Batteries.......................................................................................... 6-7 6.2.7 Remove the Main
Control Board ....................................................................... 6-8 6.2.8 Remove the Monitor
Board................................................................................ 6-9 6.2.9 Remove the Inverter (8"
display) ....................................................................... 6-9 6.2.10 Remove the 7" Display
Conversion Board (7" display)................................. 6-10 6.2.11 Remove the Power Signal
Conversion Board .................................................6-11 6.2.12 Remove the
Speaker....................................................................................... 6-12 6.2.13 Remove the
Network Conversion Board........................................................ 6-13 6.2.14 Remove the
Calibration Power Interface Board............................................. 6-14 6.2.15 Remove the
Power Board and Fan................................................................. 6-15 6.2.16 Remove the
Display, Encoder and Keypad Board ......................................... 6-17 6.2.17 Remove the
Auxiliary O2 Supply Assembly.................................................. 6-23 6.2.18 Remove the
Flowmeter Assembly.................................................................. 6-24 6.2.19 Remove the
Three-way Valve Assembly........................................................ 6-24 6.2.20 Remove the O2-
N2O Cut-off Valve Assembly .............................................. 6-25 6.2.21 Disassemble the Gas
Supply Inlet Assembly ................................................. 6-25 6.2.22 Remove the System
Switch Assembly ........................................................... 6-27

6.2.23 Remove the Pipeline Pressure Gauges ........................................................... 6-27


6.2.24 Remove the High Pressure Cylinder Yoke ..................................................... 6-29
6.2.25 Remove the Vaporizer Manifold .................................................................... 6-30
6.2.26 Remove the Worktable Cover Plate Assembly............................................... 6-30
6.2.27 Remove the Patient Circuit ............................................................................ 6-31
6.2.28 Remove the Circuit Adapter........................................................................... 6-31
6.2.29 Remove the O2 Flush Button Assembly ........................................................ 6-32
6.2.30 Remove the ACGO Assembly........................................................................ 6-32
6.2.31 Remove the Expiratory Valve Assembly........................................................ 6-33
6.2.32 Remove the Gas Reservoir Assembly ............................................................ 6-34
6.2.33 Remove the Drawer Assembly....................................................................... 6-34
6.2.34 Disassemble the Isolation Transformer .......................................................... 6-35
6.2.35 Remove the Caster ......................................................................................... 6-38
6.3 Disassemble the Breathing System ............................................................................... 6-39
6.3.1 Remove the O2 Sensor..................................................................................... 6-39
6.3.2 Remove the Breathing Tubes and Y Piece ....................................................... 6-40
6.3.3 Remove the Flow Sensor ................................................................................. 6-40
6.3.4 Remove the Manual Bag.................................................................................. 6-42
6.3.5 Disassemble the Bellows Assembly................................................................. 6-42
6.3.6 Disassemble the Pop-off Valve Assembly........................................................ 6-43
6.3.7 Disassemble the Expiratory (Inspiratory) Check Valve Assembly................... 6-44
6.3.8 Remove the CO2 Absorbent Canister .............................................................. 6-45
6.3.9 Remove the Water Collection Cup................................................................... 6-47
6.3.10 Remove the Airway Pressure Gauge.............................................................. 6-47
6.3.11 Remove the Bag Arm ..................................................................................... 6-48
6.3.12 Disassemble the CO2 Absorbent Canister Connection Block Assembly ....... 6-49
6.3.13 Remove the Upper Cover 2 and Lower Cover 2 Assemblies......................... 6-51
6.3.14 Remove the Upper Cover Assembly, Median Plate Assembly, and Lower Cover
Assembly................................................................................................................... 6-53
6.3.15 Disassemble the Bag/vent switch Assembly .................................................. 6-54
6.3.16 Remove the APL Valve Assembly.................................................................. 6-56
6.4 Electrical and Pneumatic Connections.......................................................................... 6-56
6.4.1 Electrical Connections...................................................................................... 6-57
6.4.2 Pneumatic Connections.................................................................................... 6-60

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

⌘ This equipment must be installed by factory authorized engineers and adequate


training of its use should be delivered to its user before it is put into use.

⌘ There is high voltage inside the equipment. Never disassemble the equipment
before it is disconnected from the AC power source.

⌘ This equipment can be disassembled by Mindray trained and authorized personnel


only.

⌘ Be sure of static discharge before disassembling the equipment. Wear antistatic


wrist straps or gloves when disassembling the parts labelled with static-sensitive
symbolsto avoid damage to the parts.

⌘ The equipment must be connected to a properly installed power outlet with


protective earth contacts only. If the installation does not provide for a protective
earth conductor, disconnect it from the power line.

⌘ Dispose of the packaging materials, observing the applicable waste control


regulations and keeping it out of children’s reach.

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

⌘ Refer to Operator’s Manual for detailed operation and other information.

1.2 Equipment Symbols


Attention: Consult Consult Operator’s Manual
accompanying
documents (this
manual)

Alternating current Fuse

Equipotential Autoclavable

Pipeline Not autoclavable

Standby key Network connector

Power On Power Off

System On System Off

Silence key MV&TVe alarm off key

Menu key O2 flush button

ACGO On ACGO Off

Bag position/ manual Mechanical ventilation


ventilation

O2 sensor connector Flow control

Air supply connector N2O supply connector


1-3

Cylinder O2 supply connector

Manufacture date AGSS connector

Manufacturer DB9 connector

APL valve Vaporizer

Maximum level of the Isolation transformer


CO2 absorbent canister

Gas flow direction Serial number

Lock the lifting device Lock or unlock as the


arrow shows

Approximate Unlock the lifting device

Max. weight: 30 kg Upward (Pop-Off valve)

Disassemble the Do Not Crush


breathing circuit as
shown in the figure

Type BF applied part. Driven by air


Defibrillation-proof
protection against
electric shock.

The following definition of the WEEE label applies to EU member states


only. This symbol indicates that this product should not be treated as
household waste. By ensuring that this product is disposed of correctly, you
will help prevent bringing potential negative consequences to the
environment and human health. For more detailed information with regard
to returning and recycling this product, please consult the distributor from
whom you purchased it.
* For system products, this label may be attached to the main unit only.
1-4

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)

2 O2 cylinder connector 30 AGSS

3 Air pipeline connector 31 Inspiratory check valve

4 N2O pipeline connector 32 CO2 absorbent canister

5 N2O cylinder connector 33 Bypass

6 Cylinder regulator (400 kPa) 34 O2 sensor

7 Pressure relief valve (758 kPa) 35 Airway pressure gauge

8 Drive gas inlet filter 36 Inspiratory flow sensor

9 Regulator (200 kPa) 37 Patient

1 Inspiratory flow control valve 38 Expiratory flow sensor


0

1 Inspiratory flow sensor 39 Water collection cup


1

1 Mechanical pressure relief valve 40 Expiratory check valve


2 (110 cmH2O)
13 Pop-Off valve 41 Bag/mechanical ventilation switch

14 PEEP safety valve 42 Manual bag

15 Drive gas pressure switch (140 43 APL valve


kPa)

16 Proportional PEEP valve 44 Gas monitoring module

17 Expiratory valve 45 Bellows

1 Pneumatic resistor 46 Mechanical pressure relief valve


8 (1 kPa,10 cmH2O)

19 O2 flush button 47 Negative pressure check valve


(1 cmH2O)

20 Pressure relief valve 48 Gas reservoir

21 Flow restrictor 49 Pressure sensor

22 O2 supply pressure switch (200 kPa) 50 Single-vaporizer manifold

23 Regulator (200 kPa) 51 Free breathing check valve

24 System switch 52 Air cylinder connector

25 O2-N2O cut-off valve 53 Pressure relief valve

26 Flowmeter module 54 ACGO selector switch

27 Double-vaporizer manifold 55 Auxiliary O2 supply

28 Check valve / /

2-2

2.1.3
Pneumatic
Circuit
Diagram(with
4-yoke

configuration)

t
n

r
e

v
r

o
e

t
v

it

ir

2-3
2.1.4 Parts List
1 O2 pipeline connector 31 Inspiratory check valve

2 O2 cylinder connector 32 CO2 absorbent canister

3 Air pipeline connector 33 Bypass

4 N2O pipeline connector 34 O2 sensor

5 N2O cylinder connector 35 Airway pressure gauge

6 Cylinder regulator (400 kPa) 36 Inspiratory flow sensor

7 Pressure relief valve (758 kPa) 37 Patient

8 Drive gas inlet filter 38 Expiratory flow sensor

9 Regulator (200 kPa) 39 Water collection cup

10 Inspiratory flow control valve 40 Expiratory check valve

11 Inspiratory flow sensor 41 Bag/mechanical ventilation switch

1 Mechanical pressure relief valve 42 Manual bag


2 (110 cmH2O)

13 Pop-Off valve 43 APL valve

14 PEEP safety valve 44 Gas monitoring module

15 Drive gas pressure switch (140 45 Bellows


kPa)

16 Proportional PEEP valve 46 Mechanical pressure relief valve


(1 kPa,10 cmH2O)

1 Expiratory valve 47 Negative pressure check valve


7 (1 cmH2O)

18 Pneumatic resistor 48 Gas reservoir

19 O2 flush button 49 Pressure sensor

20 Pressure relief valve 50 Single-vaporizer manifold

21 Flow restrictor 51 Free breathing check valve

22 O2 supply pressure switch (200 kPa) 52 Air cylinder connector

23 Regulator (200 kPa) 53 Pressure relief valve

24 System switch 54 ACGO selector switch

25 O2-N2O cut-off valve 55 Auxiliary O2 supply

26 Flowmeter module 56 Vacuum generator

27 Double-vaporizer manifold 57 Muffler


28 Check valve 58 Adjustable negative pressure gauge

29 Pressure relief valve (37.9 kPa) 59 Floating overfill protection valve

30 AGSS 60 Liquid collection bottle

2-4

2.1.5 Key to Symbols

Filter Regulator Pressure gauge Check valve Gas

supply connector Pressure relief valve Flowmeter Flow control

valve Pressure switch Flow restrictor Vacuum generator Muffler

Overfill protection Pressure


valve switch

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

Fresh gas inlet

Air supply N2O supply

Fresh gas inlet Fresh gas inlet

The anesthesia machine has pipeline and


cylinder gas supplies available. Pipeline gas
supplies, which are O2, N2O and Air, go into
the pipeline gas supply inlet assemblies
through pipeline connectors 1, 4 and 3
respectively. The pipeline pressure ranges
between 280 and 600 kPa. Cylinder gas
supplies, which are O2, Air and N2O, go into
the system through cylinder connectors 2, 5
and 52 respectively. The O2, Air and N2O
cylinder pressures are 6.9
–15 MPa, 6.9–15 MPa and 4.2–6 MPa
respectively, which are decreased to
approximately 400 kPa through regulator 6.
Each connector is clearly marked and designed
to prevent misconnection. All connectors have filters and check valves. Color coded gauges
show the pipeline and cylinder pressures. Pressure relief valve 7 functions to prevent the
supply gas pressure from being too high. It releases excess gas when gas pressure exceeds
approximately 750 kPa. Each supply gas is outputted after gas pressure is decreased below
approximately 200 kPa through regulator 23. Pressure switch 22 monitors the O2 supply
pressure. When O2 supply pressure is less than approximately 200 kPa, the ventilator gives
the alarm of O2 supply failure.
2-7

The following picture shows the output connectors of O2 pipeline supply inlet assembly.

Fresh gas tube

Regulator (200kPa)

Pressure switch

Drive gas tube


Pressure
sampling tube for O2 supply

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

The following picture shows the output


connector of cylinder supply inlet assembly of
anesthesia machine configured with four
yokes.

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

2.1.6.2 Anesthetic Gas Delivery System


The anesthetic gas delivery system is connected to the gas supplies, anesthetic gas delivery device
(vaporizer) and breathing system. N2O, O2 and Air supplies enter the anesthetic gas delivery system and
the mixed gas (namely fresh gas) containing these three gases and anesthetic agent and pure O2 (O2 flush)
are outputted. The following figure shows the pneumatic circuit of anesthetic gas delivery system.

2-10

The following picture takes O2+N2O+Air configuration as an example to illustrate how


pipeline supplies are outputted. O2 is divided into two pathways. One pathway of O2 flows
into system switch 24 and the other into O2 flush valve 19. N2O flows into O2-N2O cut-off
valve 25 and Air into system switch 24.

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

From ACGO to From O2 flush to


breathing system ACGO

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.

From ACGO to ACGO


separate outlet

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.

O2-N2O Cut-off Valve Assembly

25. O2-N2O cut-off valve

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

O2 Flush Button Assembly


19.O2 flush valve
The above picture shows the O2 flush button assembly. When O2 flush valve 19 is depressed,
O2 rushes into the pneumatic circuit which is cut off when the valve is released. The O2
supply gas at 0.2 MPa after regulated goes through the O2 flush valve, the ACGO assembly,
and into the breathing system. The O2 flush button assembly is not affected by the system
switch. Flushing O2 can be performed as long as O2 supply is normal. The O2 flush valve
has a slide valve structure inside which ensures automatic reset each time the valve is
depressed and released via the spring.

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

2.1.6.3 Pneumatically-controlled Module of the Anesthetic Ventilator


The pneumatically-controlled module of the anesthetic ventilator provides drive gas for the
patient to breathe. O2 (or Air) from the gas supply inlet assembly enters the pneumatically-
controlled module and is outputted in three pathways: drive gas entering the breathing
system, drive gas discharged through the AGSS outlet and drive gas discharged through the
PEEP outlet. The ventilator controls drive gas flow to prevent too high pressure inside the
pneumatic circuit from injuring the patient. The following picture shows the gas flow
direction and parts concerning the pneumatically-controlled module.

Exhaust
tube

Outputs gas
discharged through
PEEP outlet

Input tube of the


pneumatically-cont
rolled module

Outputs drive gas

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

2.1.6.4 Breathing System


The breathing system provides a closed loop for the anesthetic gas. The CO2 in the patient’s
expired gas can be inspired in the inspiration phase to maintain the temperature and humidity

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 breathing system is easily disassembled and is autoclavable at 134℃.

2.1.6.5 Anesthetic Gas Scavenging System


The anesthetic gas scavenging system (AGSS) is composed of AGSS transfer system, AGSS receiving
system and AGSS disposal system. Waste gas goes from the exhaust port of the anesthesia machine
through the AGSS transfer system and the AGSS receiving system and to the hospital’s waste gas disposal
system (AGSS disposal system), as shown below.

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.

To the waste gas


exhaust port of the anesthesia machine

GCX rail
Transfer hose
Receiving hose (European
standard) To the disposal system
Receiving hose (general)
G1/8 internal thread

Anesthetic gas receiving system

2-25

2.1.6.6 Negative Pressure Suction System


The negative pressure suction system uses pipeline Air or O2 as the drive gas. While the
drive gas is discharged from the muffler of Venturi negative pressure generator assembly,
negative pressure is produced at the negative pressure regulator according to Venturi theory.
The regulated negative pressure can suction the patient’s body fluid at the throat. The
suctioned body fluid is temporarily kept in the liquid collection bottle. Both liquid collection
bottle and negative pressure regulator assembly are integrated with overfill protection device
to prevent the patient’s body fluid from entering the negative pressure regulator and Venturi
negative pressure generator so as to damage the equipment. A filter is also connected to
prevent bacteria from contaminating the equipment or from entering the pipeline gas supply.

58.

Adjustable negative Drive gas hose pressure gauge

56. Venturi vacuum


generator

Filter 57. Muffler


60. Liquid collection
59. Floating overfill protection bottle with overfill protection
valve

2-26

3 Checkout and Test


WARNING

⌘ 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.

3.1 System Inspection


NOTE

⌘ Make sure that the breathing circuit is correctly connected and not damaged.

⌘ The top shelf weight limit is 30 kg.

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.

Make sure that:


1. The equipment is not damaged.
2. All components are correctly attached.
3. The breathing circuit is correctly connected and the breathing tubes are not damaged.
4. The vaporizers are locked in position.

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

3.2 Pipeline Tests

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.

3. Set the system switch to the position.


4. Set the flow controls to mid range.
5. Check that the pressure reading on the O2 gauge is within the range of 280 to 600 kPa
(if not, adjust the O2 pipeline output pressure). Check that other gauges go to zero.
6. Disconnect the O2 pipeline supply.
7. As O2 pressure decreases, alarms for [O2 Supply Failure] and [Drive Gas Pressure
Low] should occur. The alarm for [Drive Gas Pressure Low] occurs only when O2 is
the drive gas.
8. Connect other pipeline supplies. Check that the readings on the gauges fall within the
range of 280 to 600 kPa.

3.3 Cylinder Tests


NOTE

⌘ To prevent damage, open the cylinder valves slowly.

⌘ 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.

This test is not required if cylinders are not configured.

3-2

3.3.1 Check the Cylinders are Full


Check the cylinders of the anesthesia machine one by one as follows:

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.

3.3.2 Cylinder High Pressure Leak Test

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.

1. Make sure that the system switch is in the position.

2. Close the auxiliary O2 supply flowmeter if auxiliary O2 supply is configured. 3.


Turn all the flow controls fully clockwise (minimum flow).

4. Open the cylinder valve.


5. Record the current cylinder pressure.
6. Close the cylinder valve.
7. Record the cylinder pressure after one minute. There is a leak

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.

3.4 Flow Control System Tests


3.4.1 Without O2 Sensor

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.

To do the flow control system tests:


1. Connect the pipeline supplies or slowly open the cylinder valves.
2. Turn all flow controls fully clockwise (minimum flow).

3. Set the system switch to the position.

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

7. Test the Link system with O2 flow decreasing:


a. Set the N2O flow to 9.0 L/min.
b. Set the O2 flow to more than 3 L/min.
c. Slowly turn the O2 flow control clockwise to set the N2O flow to the rates shown in the
table. Make sure that the O2 flow must be greater than the minimum limits.
d. If the O2 flow is set crossing the limit, before continuing the test, turn the N2O flow
control counterclockwise till the N2O flow increases to the preset value.

3-4

Step N2O flow (L/min) O2 flow (L/min)

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.

10. Set the system switch to the position.

3.4.2 With O2 Sensor


Do as described in 3.9.2Test the O2 Concentration Monitoring and Alarms before testing.
To do the flow control system tests:
1. Connect the pipeline supplies or slowly open the cylinder valves.
2. Turn all flow controls fully clockwise (minimum flow).

3. Set the system switch to the position.

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.

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 and the O2 flow should


increase accordingly. The measured O2 concentration must be
≥25% through the full range.

3-5

7. Test the Link system with O2 flow decreasing:


a. Set the N2O flow to 9.0 L/min.
b. Set the O2 flow to more than 3 L/min.
c. Slowly turn the O2 flow control clockwise and the N2O flow
should decrease accordingly. The measured O2
concentration must be ≥25% through the full range.
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 pipeline supply or close the cylinder valve.

10. Set the system switch to the position.

3.5 Vaporizer Back Pressure Test

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.

3.6.2 In Manual Ventilation Mode


1. Set the Bag/vent switch to the bag position.

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

⓿ The 3 L bag is fully inflated within 3 to 6 seconds.

⓿ The 1 L bag is fully inflated within 1 to 3 seconds.

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.

3.7.1 Bellows Test


1. Set the system to Standby.
2. Set the Bag/vent switch to the mechanical ventilation position.
3. Set all flow controls to minimum.
4. Connect the Y piece on the breathing tube to the leak test plug to occlude the outlet of
the Y piece..

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.

3.7.2 Breathing System Leak Test in Manual Ventilation Mode

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.

3.7.2.1 Software Auto Test


There are two ways available to enter the software auto test screen.
Way 1: Push the [Maintenance] key to enter the maintenance menu. Select [Factory
Maintenance>>] and enter the required password to enter the factory maintenance menu.
Select [System Setup] and switch on leak test in the system setup menu. Then restart the
machine. Select [Continue] on the startup selftest result screen to enter the manual leak test
screen.
Way 2: Make sure that the system is Standby. If not, press the key and select [Ok] from
the pop-up menu to enter Standby. Push the [Maintenance] key to enter the maintenance
menu. Select [System Leak&Compliance Test] to enter manual leak test screen.

To do the manual leak 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.

⓿ “Pass” is displayed if the manual leak test is passed.

⓿ “Fail” is displayed in red if the manual leak test is failed.


3-9

3.7.2.2 Manual Test


To do the breathing system leak test in manual ventilation mode:

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.

3.7.2.3 Commonly-encountered Problems and Recommended Actions


The following table lists the commonly-encountered problems and recommends actions for
breathing system leak test in manual ventilation mode.
Failure description Possible cause Recommended action

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.

2. The bag/vent switch is not Set the bag/vent switch to the


set to the bag position. mechanical ventilation
position.

Manual circuit is leaky. 1. The Y piece on the Check the pneumatic


breathing tube is not connections and do the test
connected to the test plug. again strictly following the
2. The APL valve is not operation
turned to the maximum instructions.
pressure.
3. The manual bag port is
not occluded with test
lung.
4. The CO2 absorbent canister
is not installed in place.
3-10

3.7.2.4 Definitions of Error Information during Breathing System Leak


Test in Manual Ventilation Mode
During the leak test, many abnormal factors or operations may result in breathing system
manual circuit leak test failure. The following table lists the definitions of various abnormal
factors. If the breathing system leak test fails, the relevant error code will be recorded in the
service logbook.
S/N Cause Description Error code

1 The user cancels the / 0000 0001


command.

2 The bag/vent switch is in / 0000 0002


vent position.

3 ACGO is ON. / 0000 0004

4 O2 supply pressure is low. / 0000 0008

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.

3.7.3 Breathing System Leak Test in Mechanical Ventilation

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

3.7.3.1 Test Procedures

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.

To do the breathing system leak test in mechanical ventilation mode:


To do the breathing system leak test in mechanical ventilation mode:

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.

5. Make sure that the bag/vent switch is set to the position.


6. Push the O2 flush button to fill the bellows, bellows rising to the top.
7. Select the [Maintenance] shortcut key and select [System Leak&Compliance Test] to
enter the manual leak test screen. Select [Skip] to enter the auto leak test screen. Select
[Continue] to start the breathing system leak test and compliance test in mechanical
ventilation mode. Typically, the test requires 3 to 5 minutes.
8. When the leak test is completed, the screen for auto leak&compliance test result is
switched to automatically, prompting the system leakage and system compliance test
result.
1) If the leakage is less than or equal to 200 ml/min, it indicates that the system has good
airtightness. The actual leakage is displayed in green.
2) If the leakage is between 200 and 1000 ml/min (including 1000 ml/min), it indicates that
the system has some leakage. The actual leakage is displayed in red.
3) If the leakage is greater than 1000 ml/min, it indicates that the system has significant
leakage. “>1000 ml/min” is displayed in red.
4) “Fail” is displayed directly when the leak test cannot be executed or the leakage is too
serious.

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

3.7.3.2 Commonly-encountered Problems and Recommended Actions


The following table lists the commonly-encountered problems and recommends actions for
breathing system leak test in mechanical ventilation mode.
Failure description Possible cause Recommended action

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 ACGO switch is turned Turn off the ACGO switch.


on and the screen displays
prompt message of ACGO.

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

Failure description Possible cause Recommended action

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.

3.7.3.3 Definitions of Error Information during Breathing System Leak


Test in Mechanical Ventilation Mode
During the leak test, many abnormal factors or operations may result in breathing system
manual circuit leak test failure. The following table lists the definitions of various abnormal
factors. If the breathing system leak test fails, the relevant error code will be recorded in the
service logbook.
S/N Cause Description Error code

1 The user cancels the / 0000 0001


command.

2 The bag/vent switch is in / 0000 0002


bag position.

3 ACGO is ON. / 0000 0004

4 The drive gas pressure is low. / 0000 0008

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 flow sensor has an error. / 0000 0020


7 Pressure rise time is too long. The longest time for pressure to rise to 0000 0040
the specified pressure threshold
30cmH2O (+5cmH2O) exceeds 30s.

8 Pressure drops drastically. Pressure is less than 18cmH2O. 0000 0080

9 Leakage is too large. Leakage exceeds 1000ml/min. 0000 0100

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.

3.7.4 APL Valve 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 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.

9. Set the O2 flow to 3 L/min. Turn any other gases off.


10. Make sure that the reading on the airway pressure gauge is less than 5 cmH2O.
11. Push the O2 flush button. Make sure that the reading on the airway pressure gauge does
not exceed 10 cmH2O.
12. Turn the O2 flow control to set the O2 flow to minimum. Make sure that the reading on
the airway pressure gauge does not decrease below 0 cmH2O.

3-16

3.8 Pressure Relief Valve Test


This test can be performed if ACGO is configured.
Perform the pressure relief valve test by using the following tools:

④ Anesthesia machine calibration device (quantity:1)

④ Circuit adapter test fixture (quantity:1)

④ Injector (100 ml) (quantity:1)

④ Φ6 silicone tube (quantity:2)

④ PU tube (6X300) (quantity:1)

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).

3.9 Alarm Tests


3.9.1 Prepare for Alarm Tests
1. Connect a test lung or manual bag to the Y piece patient connection.

2. Set the Bag/vent switch to the position.

3. Set the system switch to the position.

4. Set the system to Standby.


5. Set the ventilator controls as follows:

⓿ Ventilation mode: select [Vent Mode] and then [VCV].

⓿ [TV]: 500 ml.

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:

⓿ The ventilator displays the correct data.

⓿ The bellows inflates and deflates normally during mechanical ventilation.

3-18

3.9.2 Test the O2 Concentration Monitoring and Alarms


NOTE

⌘ This test is not required if O2 sensor is not configured.

1. Set the Bag/vent switch to the position.

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

3.9.4 Test the Apnea Alarm


1. Connect the manual bag to the manual bag port.

2. Set the Bag/vent switch to the position.

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.

3.9.5 Test the Sustained Airway Pressure Alarm


1. Connect the manual bag to the manual bag port.

2. Turn the O2 flow control to set the O2 flow to minimum.


3. Turn the APL valve control to set the APL valve to 30 cmH2O position. 4.

Set the Bag/vent switch to the position.

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

1. Set the Bag/vent switch to the position.

2. Select [Alarm Setup] and then [Ventilator >>].


3. Set the Paw low alarm limit to 0 cmH2O and Paw high alarm limit to 5 cmH2O. 4.
Make sure that a high Paw alarm occurs.
5. Set the Paw high alarm limit to 40 cmH2O.
6. Make sure the high Paw alarm cancels.

3-20

3.9.7 Test the Low Paw Alarm

1. Set the Bag/vent switch to the position.


2. Select [Alarm Setup] and then [Ventilator >>].
3. Set the Paw low alarm limit to 2 cmH2O.
4. Disconnect the manual bag from the Y piece patient connection.
5. Wait for 20 seconds. View the alarm area and make sure that a low Paw alarm occurs.
6. Connect the manual bag to the manual bag port. Push the O2 flush button to fill the
bellows, bellows rising to the top.
7. Make sure the low Paw alarm cancels.

3.10 AGSS Inspection


3.10.1 Check the Float
Install the AGSS and connect the gas supplies. Check if the float floats off and is between the
MAX and MIN levels. If the float fails to be between the MAX and MIN levels by turning
the flow adjustment knob at the top of AGSS, or if the float is tacky or damaged, re-install the
AGSS or replace the float.

NOTE

⌘ Do not block the AGSS pressure compensation openings during the inspection.

If the float fails to float off, the possible reasons are:


1. The float is tacky or stuck to the guide bar. Invert the AGSS and check if the float
moves up and down freely. If not, clean where the float and guide bar meet to remove
possible foreign substance. Replace the float or guide bar when necessary.
2. The filter screen inside the top cove may be occluded. Remove the filter screen as
described below and check if the filter screen is occluded.

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.

3.10.2 Check the Transfer Tube and Active Scavenging Tube


1. Disconnect the tubes from other components.
Check the transfer tube and its connectors for damage.
Check if the transparent silicone hose for damage.
Transfer tube

3-22

2. Check the receiving hose regarding the following three aspects:


a. The receiving hose and its connectors for damage.
b. If the connections between the receiving hose and its connectors are loose. c.
The sealing ring for damage.

Hose and connector


Sealing ring

If any damage or loose connection is detected, replace the corresponding part.

3.11 Negative Pressure Suction Inspection 3.11.1 Check


the Tube Connections of Liquid Collection Bottle
1. Check if the tubes are correctly connected following the connection diagram printed on
the liquid collection bottle. If not, the overfill protection device cannot work normally.
2. Check if the tubes are inserted in place. If not, leakage may occur, resulting in failure to
reach negative pressure of 40 kPa.
3-23

3.11.2 Check the Negative Pressure


1. Read the reading on the Air pipeline pressure gauge on the front side of the anesthesia
machine and make sure that the pipeline supply gas pressure is within the normal
pressure range.
2. Set the swapping switch on the negative pressure regulator to REG position. 3.
Set the switch of Venturi negative pressure generator to ON position. 4. Occlude
the patient connection outlet of suction tube with hand.
5. Check if the reading on the negative pressure regulator is greater than 40 kPa. If it is less
than 40 kPa, check the following:
a. Increase the pressure at the rear end of negative pressure regulator clockwise.
b. Rotate counterclockwise to remove the muffler. Shake dust and foreign substance
from the muffler.
c. Occlusion can occur after the filter is used for a long time. Replace the filter and do the
test again.
3.12 Power Failure Test
1. Connect the anesthesia machine to the AC power source. Both AC power LED should
come on. If the AC power LED is not lit, check the fuse and power board.

2. Set the system switch to the position.

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

3.13 Electrical Safety Inspection


NOTE

⌘ Perform electrical safety inspection after servicing or routine maintenance. Before


the electrical safety inspection, make sure all the covers, panels, and screws are
correctly installed.

⌘ The electrical safety inspection should be performed once a year.

3.13.1 Auxiliary Electrical Outlet Test


Verify the mains voltage is present at each auxiliary outlet when the anesthesia machine is
connected with power.

3.13.2 Electrical Safety Inspection Test


1. Perform protective earth resistance test:
a. Plug the probes of the analyzer into the protective earth terminal and equipotential
terminal of the AC power cord.
b. Test the earth resistance with a current of 25 A.
c. Verify the resistance is less than 0.1ohms (100 mohms).
d. Plug the probes of the analyzer into the protective earth terminal of the AC power
cord and the protective earth terminal of any auxiliary outlet. Repeat steps b and c.
e. If the resistance is larger than 0.1ohms (100 mohms) but less than 0.2ohms (200 mohms),
disconnect the AC power cord and plug the probe that is previously plugged in the
protective earth terminal of the AC power cord into the protective earth contact of the
power outlet. Repeat steps a to d.
2. Connect the compressor, if configured, to the auxiliary electrical outlet. 3.
Perform the following earth leakage current tests:

⓿ normal polarity;

⓿ reverse polarity;

⓿ normal polarity with open neutral; and

⓿ reverse polarity with open neutral.

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.

3.13.3 Electrical Safety Inspection Form


Location: Technician:

Equipment: Control Number:

Manufacturer: Model: SN:

Measurement equipment /SN: Date of Calibration:

INSPECTION AND TESTING Pass/ Limit


F
ail

1 Auxiliary mains socket outlets

2 Protective Earth Resistance Ω Max 0.1 Ω

3 Earth Normal ____μA Max:


Leakage condition(NC) NC: 500μA
SFC: 1000μA

Single Fault ____μA


condition(SFC)
For periodically performance, all the test items included in the ELECTRICAL SAFETY
INSPECTION FORM shall be performed. The following table specifies test items to be
performed after the equipment is repaired with main unit disassembled.
When neither power supply Test items: 1, 2
PCBA, transformer nor patient
electrically-connected PCBA is repaired
or replaced

When power supply PCBA or Test items: 1, 2, 3


transformer is repaired or replaced

3-26

4 Maintenance and Calibration


WARNING

⌘ 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.

⌘ When the equipment to be maintained contains blood or other secretion, clean,


disinfect and sterilize the equipment by strictly following the control and safety
handling procedures for infectious diseases.

4.1 Equipment Maintenance


To ensure the long-term reliability and stability of the anesthesia machine, periodical
maintenance of the equipment and replacement of its parts must be performed by authorized
service personnel. For details about parts replacement, refer to6Repair and Disassembly
Periodical parts replacement can be carried out every year or every three years. Make records
of the parts that have been replaced before the periodical replacement.

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

4.1.1 One-year Replaceable Parts


List of one-year service package (0621-30-78479):
SN P/N Description Qty

1 0611-20-45600 Gas supply inlet filter 3

2 M6M-010021--- Seal for gas supply inlet assembly 3

3 M6M-010014--- Seal for vaporizer manifold 4

4 M6M-010031--- Seal for valve cover 2

5 M6M-010033--- Valve seal 2

6 M6M-010058--- Seal for bag arm 2

7 M6M-010038--- Seal for water collection cup 1

8 049-000154-00 Sealing cushion for CO2 absorbent canister outlet 1

9 0601-20-78842 Sealing component for CO2 absorbent canister 1

10 M6M-010051--- Seal for CO2 absorbent canister support 1

11 M6M-010063--- Seal for pressure sampling connector 4

12 M6M-010006--- Seal for fresh gas and ACGO 2

13 M6M-010058--- Seal for drive gas and APL discharge 2

14 0601-20-78848 Seal for bellows housing 1

15 049-000049-00 Bellows 1

16 0030-10-13077 Seal for axis of Bag/vent switch 2

17 0601-20-78840 BYPASS large sealing cushion 1


18 049-000415-00 Sealing cushion at the outlet (20L) 1

19 049-000416-00 Sealing cushion for CO2 absorbent canister(20L) 1

20 049-000422-00 Sealing cushion for adapter plate (20L) 1

4-2

4.1.1.1 Parts Replacement


1. As required, replace the gas supply inlet filter (0611-20-45600) and seal for gas supply
inlet assembly (M6M-010021---) every 12 months. Unscrew the gas supply inlet
counterclockwise using a wrench to disassemble the gas supply inlet assembly as shown
below (take O2 supply inlet as an example).
Seal (M6M-010021---)

Filter (0611-20-45600)
4-3

2. As required, replace the seals (M6M-010014---) where vaporizer manifold connectors


meet the vaporizers every 12 months

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---)

5. For WATO EX-25/30/35 anesthesia machine, as required, replace the sealing


component for CO2 absorbent canister outlet (049-000154-00) and sealing component
for CO2 absorbent canister (0601-20-78842) every 12 months.

Sealing component for CO2


absorbent canister
(0601-20-78842)

Sealing component for CO2


absorbent canister outlet
(049-000154-00)

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.

Seal (M6M-010058---) Seal (M6M-010063---) Seal (M6M-010006---)

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)

Seal for bellows


housing
(0601-20-78848)
4-8

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)

4.1.1.2 Checkout and Test of the Anesthesia Machine


Perform the following maintenance procedures every 12 months:
1. System inspection (refer to 3.1).
2. Pipeline test (refer to 3.2).
3. Cylinder test (refer to 3.3).
4. Flow control system test (refer to 3.4).
5. Vaporizer back pressure test (refer to 3.5).
6. O2 flush test (refer to 3.6).
7. Breathing circuit test (refer to 3.7).
8. Pressure relief valve test (refer to 3.8).
9. Alarm test (refer to 3.9).

4-10

10. AGSS inspection (refer to 3.10). 11.


Power failure test (refer to 3.12). 12.
Electrical safety test (refer to 3.13).

13. Flow sensor calibration (refer to 4.3.2).


14. O2 sensor calibration (refer to 4.3.5).
15. APL valve accuracy adjustment (refer to 0).
16. Low pressure leak test (refer to steps 1 through 8 of “4.Leak test of all pipelines on the
circuit adapter” in 5.3.4.2Leak Test of Low-pressure Pneumatic Circuit System).

4.1.2 Three-year Replaceable Parts


List of three-year service package (0621-30-78480):
SN P/N Description Qty

1 M05-010001-06 Lithium battery Li-ion 11.1V4400mAh LI23S001A 1

2 M05-010R03--- Cell battery Lithium 3V35mAh D12.5*2.0 1

4.2 System Test


Before the anesthesia machine at the client end is maintained, some routine tests are required
to check if the current status of the anesthesia machine is normal. The following table lists the
routine tests.
SN Test item Functional description Test interval

1 Check 1. Check if mechanical ventilation is provided After each


the normally and if an alarm occurs. service or at
mechanic 2. Check if the preset values of pressure and TV are the time of
al same to the measured values. return
ventilatio 3. Check if the pressure measured by the pressure sensor visit
n mode is same to that indicated by the airway pressure gauge
and if the TV measured by the flow sensor is same to
that indicated by the graduation on the bellows housing.
4. Roughly judge if the breathing system has a
significant leak by observing how much fresh gas is
compensated and observing if the bellows collapses.

2 Breathing 1. Check the pneumatic circuit in mechanical After each


system ventilation mode for leaks, including bellows, drive service or at
leak test gas circuit, CO2 absorbent canister, patient tubes, flow the time of
in sensors and their connectors. return
mechanic 2. Check the control effectiveness of main control visit
al board and auxiliary control board over PEEP safety
ventilatio valve. 3. Check the monitoring effectiveness of
n mode auxiliary control module over airway pressure and
PEEP path pressure.

4-11

SN Test item Functional description Test interval


3 Breathing Check the pneumatic circuit in manual ventilation After each
system mode for leaks, including APL valve, check valve, service or at
leak test CO2 absorbent canister, patient tubes, flow sensors the time of
in and their connectors. return
manual visit
ventilati
on
mode

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

5 Check 1. Check if the measurements made by the flow After each


the sensors inside the machine are the same. service or at
flow 2. Check if the measurement made by any flow the time of
sensor sensor inside the machine is accurate. return
accuracy 3. Check the effectiveness of flow calibration visit
(factory) result.

6 Check 1. Check if the measurements made by the After each


the pressure sensors inside the machine are the service or at
pressure same. the time of
sensor 2. Check if the measurement made by any pressure return
accuracy sensor inside the machine is accurate. visit
3. Check the effectiveness of pressure calibration
(factory) result.

4.2.1 Check the Mechanical Ventilation Mode

NOTE

⌘ The main function of the anesthesia machine is to provide breathing support—


mechanical ventilation which complies with the doctor’s settings to the patient. The
tests in this section are performed aiming to ensure that the machine is able to
provide normal mechanical ventilation.

⌘ The tests can help to judge if the machine operates normally.

4.2.1.1 Check Volume Control Ventilation

NOTE

⌘ Volume control ventilation (VCV) is the standard ventilation mode of the


anesthesia machine and also the most basic mechanical ventilation mode.
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To check volume control ventilation:


1. Make sure that the supply pressure is normal and that the tubes in the breathing circuit are
correctly connected as required for mechanical ventilation. Connect a 2 L bag, which is
used as the test lung, to the Y piece in the patient circuit.
2. Set the Bag/vent switch to the mechanical ventilation position.
3. Select VCV as the ventilation mode.
4. Adjust total amount of fresh gas to 0.5 L/min.
5. Set the following combinations of TV and Rate respectively: 300 ml and 15 BPM, 600
ml and 15 BPM, 900 ml and 15 BPM, 1200 ml and 15 BPM. Set others to the defaults.
Record the displayed TVe and Ppeak values, and the peak pressure reading on the
airway pressure gauge in each setting stabilized status.
6. Judge if the above measured data meet the following conditions:

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.
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4.2.1.2 Check Pressure Control Ventilation

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.

To check pressure control ventilation:


1. Make sure that the supply pressure is normal and that the tubes in the breathing circuit are
correctly connected as required for mechanical ventilation. Connect a 2 L bag, which is
used as the test lung, to the Y piece in the patient circuit.
2. Set the Bag/vent switch to the mechanical ventilation position.
3. Select pressure control ventilation as the ventilation mode.
4. Adjust total amount of fresh gas to 0.5 L/min.
5. Set the following combinations of Pinsp, Rate and PEEP respectively: (10 cmH2O, 15
BPM, OFF), (15 cmH2O, 12 BPM, 5 cmH2O), (20 cmH2O, 10 BPM, 8 cmH2O). Set others
to the defaults. Record the displayed Ppeak and PEEP values, and maximum and minimum
readings on the airway pressure gauge in each setting stabilized status
6. Judge if the above measured data meet the following conditions:

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.
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4.2.2 Breathing System Leak Test in Mechanical Ventilation

Mode
For details, refer to 3.7.3Breathing System Leak Test in Mechanical Ventilation Mode.

4.2.3 Breathing System Leak Test in Manual Ventilation Mode


For details, refer to 3.7.2Breathing System Leak Test in Manual Ventilation Mode.

4.2.4 Check the Sensor Zero Point

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 of the inspiratory/expiratory flow sensor has an error, in


ventilation status, the baseline of the flow waveform is not at the zero point and a
great deviation occurs between TV 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.

To check the sensor zero point:


1. Turn off all fresh gases and position the Y piece connector in the patient circuit to the
air.
2. Make sure that the system is Standby. Select [Maintenance] → [Factory
Maintenance >>] → [Diagnostic Test >>] → [Display A/D Channels >>] →
[Ventilator >>] to access the [Display A/D Channels—Ventilator] menu.
3. Make sure that the actual measured value of each sensor is “0” (zero). Record the zero
point A/D value of each sensor and judge if the zero point falls with the normal range. If
not, replace the monitor board.
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4.2.5 Check the Flow Sensor Accuracy

NOTE

⌘ If a great deviation of TV measured value occurs, test the measurement accuracy


of flow sensors so as to determine whether to perform flow calibration again.

To check the measurement accuracy of flow sensors:


1. Make sure that the circuit, test device (or other flow measurement device) and breathing
tubes are connected in serial, similar to tubes connection in flow calibration. For details,
refer to4.3.2Flow Calibration (factory).
2. When the system is Standby, select [Maintenance] → [Factory Maintenance >>] →
[Diagnostic Test >>] → [Valves—Test Tool >>] to access the [Valves—Test Tool]
menu.
3. Set PEEP safety valve to [ON].
4. Set the D/A value of the PEEP valve to above 1500 and ensure that the pressure at
which the expiratory valve closes is above 30 cmH2O.
5. Increase the D/A value of the inspiratory valve, causing the measured flow of the
anesthesia machine test device to fall within the following ranges respectively: (3±0.5)
L/min, (10±1) L/min, (20±1) L/min, (30±2) L/min, (60±3) L/min. Record the measured
flows of the inspiratory flow sensor, expiratory flow sensor and ventilator flow sensor to
which each setting corresponds.
6. Make sure that the deviation between the measured data of the inspiratory flow sensor,
expiratory flow sensor or ventilator flow sensor, and that of the anesthesia machine test
device must not exceed 1 L/min or 5% of the measured value of the test device,
whichever is greater. Otherwise, refer to 4.3.2Flow Calibration (factory) to perform
flow calibration again.
7. If anesthesia machine test device is unavailable, you can execute steps 1 through 5 to test
the accuracy of flow sensors. The deviation between the measured data of the
inspiratory flow sensor or expiratory flow sensor, and that of the ventilator flow sensor
must not exceed 1 L/min or 5% of the measured value of the ventilator flow sensor,
whichever is greater. Otherwise, refer to 4.3.2Flow Calibration (factory) to perform
flow calibration again.
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