Anesthesia Machine Maintenance

Kit Replacement Guide

(For Normal Breathing Circuit Only)

Ver 1.0

Mindray International Customer Service Department

Life Support Product – Anesthesia Machine
REVISION CONTROL

Document Title:

Anesthesia Machine Maintenance Kit Replacement Guide

Author:

International Customer Service Department

Date By Action Pages

May 30th, 2013 Rusty Song Initial Version All

Review/Approval History

Date By Action Pages

All
1. P/N of the Maintenance Kits
Machine P/N Description

WATO EX-20/30/35

WATO EX-55/65(old
type & new type with
normal breathing
circuit)

2. Contents of the maintenance kit

2.1. One year maintenance kit

NOTE: There are three types of one year maintenance kit—basic, extended and
complete maintenance kit. The higher level maintenance kit covers the materials of
the lower kit.

WATO EX-20/30/35
P/N Qty Description Remarks
0611-20-45600 3 Filter for gas supply inlet assembly For basic
M6M-010014--- 4 Vaporizer manifold sealing ring For basic
M6M-010021--- 3 Gas supply inlet assembly sealing ring For basic
M6M-010033--- 2 Check valve sealing ring For basic
M6M-010038--- 1 Water trap sealing ring For basic
M6M-010031--- 2 Check valve cover sealing ring For basic
0601-20-78842 1 Sodalime canister gasket For basic
049-000154-00 1 Sodalime canister outlet gasket For basic
Sodalime canister canister support
M6M-010051--- 1 For basic
rack sealing ring
049-000243-00 1 Bellows housing gasket For basic
M6M-010001--- 1 Pressure gauge sealing ring For basic
082-000673-00 2 Bag arm sealing ring For basic
0601-20-69771 1 Pop-off valve rubber gasket For basic
Sealing ring for driving gas and APL For basic
M6M-010058--- 2
release
M6M-010032--- 1 Pop-off valve cover plate sealing ring For basic
M6M-010063--- 4 Sealing ring for pressure sampling port For basic
M6M-010006--- 2 Sealing ring for fresh gas and ACGO For basic
0601-20-78840 1 ByPASS gasket For basic
040-000358-00 1 Bellows For extended
0611-10-45654 1 O2 sensor For complete
0601-30-69700 1 Inspiratory flow sensor For complete
0601-30-78894 1 Expiratory flow sensor For complete

WATO EX-55/65(old type & new type with normal breathing circuit)
P/N Qty Description Remarks
0611-20-45600 3 Filter for gas supply inlet assembly For basic
M6M-010014--- 4 Vaporizer manifold sealing ring For basic
M6M-010021--- 3 Gas supply inlet assembly sealing ring For basic
M6M-010033--- 2 Check valve sealing ring For basic
M6M-010038--- 1 Water trap sealing ring For basic
M6M-010031--- 2 Check valve cover sealing ring For basic
0601-20-78842 1 Sodalime canister gasket For basic
049-000154-00 1 Sodalime canister outlet gasket For basic
Sodalime canister canister support
M6M-010051--- 1 For basic
rack sealing ring
0601-20-78848 1 Bellows housing gasket For basic
M6M-010001--- 1 Pressure gauge sealing ring For basic
082-000673-00 2 Bag arm sealing ring For basic
0601-20-69771 1 Pop-off valve rubber gasket For basic
Sealing ring for driving gas and APL For basic
M6M-010058--- 2
release
M6M-010032--- 1 Pop-off valve cover plate sealing ring For basic
M6M-010063--- 4 Sealing ring for pressure sampling port For basic
M6M-010006--- 2 Sealing ring for fresh gas and ACGO For basic
0601-20-78840 1 ByPASS gasket For basic
040-000358-00 1 Bellows For extended
0611-10-45654 1 O2 sensor For complete
0601-30-69700 1 Inspiratory flow sensor For complete
0601-30-78894 1 Expiratory flow sensor For complete

2.2. Three years maintenance kit

WATO EX-20/30/35 & WATO EX-55/65(old type)

P/N Qty Description Remarks
M05-010001-06 1 Lithium-ion Battery (11.1V, 4400 mAh)
 M05-010R03--- 1 Lithium battery 3V 35mAh D12.5*2.0

WATO EX-55/65(new type with normal breathing circuit)

P/N Qty Description Remarks
Li-ion battery Li-ion11.1V4500mAh
022-000008-00 1
LI23S002A
M05-010R03--- 1 Lithium battery 3V 35mAh D12.5*2.0

3. Tests before the maintenance

3.1 Mechanical & Manual Leak Test

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.

3.1.1 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.
� “Pass” is displayed if the manual leak test is passed.
� “Fail” is displayed in red if the manual leak test is failed.

3.1.2 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 at the bag connector 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 vent 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.
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: If the leak test fails, please troubleshoot the leak failure before perform the
maintenance.

3.2 Check mechanical ventilation mode

To check VCV:
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:
� TV control and measurement are normal: the displayed TVe value should be within the range of
TV setting X (1±10%) ml.
� Circuit leak is within the acceptable range: the folding bag can reach the top of the bellows
housing each time and the lowest graduation on the bellows housing which the bag falls to each
time corresponds to approximately TV setting.
� 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.
� 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 VCV test, perform troubleshooting and do the test
again until the system is normal.

4. Parts Replacement
NOTE: The content of the maintenance kit for normal breathing circuit and Prepak
breathing circuit is different. Please use corresponding maintenance kit.

4.1 One Year Maintenance Kit

1) As required, replace the inlet (0611-20-45600) of gas supply inlet assembly and sealing ring
(M6M-010021---) every 12 months. Open gas supply inlet counterclockwise using a wrench
and disassemble the gas supply inlet assembly as shown below (take O2 supply inlet as an
example).
 Sealing ring
(M6M-010021---)

Filter
(0611-20-45600)

2) As required, replace the sealing ring (M6M-010014---) where vaporizer manifold connectors
meet the vaporizers every 12 months.

Sealing ring
(M6M-010014---)

3) As required, replace the sealing ring (M6M-010063---) at the pressure sampling port, sealing
ring (M6M-010006---) for fresh gas and ACGO, sealing ring (M6M-010058---) for drive gas
and APL release every 12 months.
 Sealing ring
(M6M-010063---)

Sealing ring Sealing ring

(M6M-010058---) (M6M-010006---)

4) As required, replace the sealing ring (M6M-010031---) on the valve cover and sealing ring
(M6M-010033---) on the valve body every 12 months.

5) As required, replace the sealing ring (M6M-010038---) on the water collection cup every 12
months.
6) As required, replace the sealing part (049-000154-00) at the sodalime canister outlet, sealing
part (0601-20-78842) on the sodalime canister and protective cover every 12 months.

Sealing part on the

sodalime canister
(0601-20-78842)

Sealing part at the

sodalime canister
outlet
(049-000154-00)

7) As required, replace the sealing ring (M6M-010051---) on the sodalime canister support rack
every 12 months.
8) As required, replace the bellows sealing ring (0601-20-78848) and bellows (040-00358-00)
every 12 months.

9) As required, replace the Bypass big sealing cushion (0601-20-78840) every 12 months.
10) Replace the pressure gauge sealing ring (M6M-010001---).

Pressure gauge
sealing ring
(M6M-010001---)

11) Replace the bag arm sealing ring (082-000673-00).

12) Replace the Pop-off valve rubber gasket (0601-20-69771).
 Pop-off valve
rubber gasket
(0601-20-69771)

13) Replace the Pop-off valve cover plate sealing ring (M6M-010032---).

4.2 Three Years Maintenance Kit

1) Replace the backup battery every 36 months.

2) Replace the cell battery (M05-010R03---) every 36 months.