MR860AEU Technical Manual Rev B May 2011.pdf
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HumiGard™
Surgical Humidifier Technical Manual
REF MR860AEU
Page 2
Revision
Description of Technical Manual Change
Date Issued
A
First release technical manual
February - 2011
B
Revision to Spare Parts List §17
May - 2011
Note:
This technical manual covers software version 3.0.x, and updated Printed Circuit Board (PCB) set with control
board 347042519 Rev A and power board 347042520 Rev A or later
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TABLE OF CONTENTS
1
About this Manual
2
2
Glossary
3
3
Definitions
3
4
Intended Use
3
5
Warnings
4
6
General Precautions
5
7
Symbols
5
8
Approved Accessories
6
9
Device Description
6
10
Accessories Description
7
11
Mode of Operation
8
12
Specifications
9
13
Maintenance Procedures
11
13.1 Maintenance Schedule
11
13.2 Safety Check
11
13.3 Cleaning Instructions
11
14
Troubleshooting
12
14.1 “Hardware Fault” Error Codes
14
Servicing Procedures
15
15.1 Disassembly
15
15.2 Servicing
16
Performance Testing
22
16.1 Surgical Humidifier Performance Testing
22
16.2 Adaptor Accuracy Check
24
17
Spare Parts
26
18
Heater-plate Assembly
28
19
Product Change History
30
20
Electromagnetic Compatibility Information
30
15
16
Appendix A. Recommended Maintenance Checklist
34
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1. About this Manual
This manual is intended for qualified service personnel who will perform maintenance and servicing on the
MR860AEU Surgical Humidifier and 900ST100 Adaptor. This manual covers the product specifications and
maintenance schedule, and provides the necessary information required for servicing.
Maintenance procedures should be carried out at regular intervals, as recommended in the maintenance
schedule, to ensure that the humidifier and its accessories are working correctly.
If a fault should occur with the humidifier, follow the troubleshooting guide (Section 14) in order to find the
most likely cause. If the unit requires servicing, make sure the servicing procedures are carefully followed
in order to prevent damage to the humidifier. After service, or as part of the maintenance schedule, a
humidifier performance check should be completed.
Due to the nature of the electronics contained within this humidifier, it is not recommended that the Printed
Circuit Boards (PCBs) are serviced at a component level. Instead, if the PCBs are found to be malfunctioning,
they should be replaced.
For instructions on how to operate the F&P HumiGard™ Surgical Humidification System please refer to the relevant
instructions for use.
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2. Glossary
Adaptor
900ST100 Adaptor is comprised of four components: heater-wire plug, chamber probe,
ambient sensor and humidifier plug.
Humidification chamber
Chamber that holds water used to humidify and warm the insufflation gas.
Chamber set point
The temperature that the humidifier attempts to maintain at the chamber probe port.
Chamber probe
Part of the adaptor which measures the chamber outlet temperature and flow rate of
the gas travelling through the humidified insufflation tube.
Humidified insufflation tube
Tubing used to deliver humidified warm gas for insufflation.
Heater-wire
Wire inside the humidified insufflation tube used to heat the gas.
Heater-wire plug
Part of the adaptor which provides electrical connection from the adaptor to the
humidified insufflation tube heater-wire.
Humidifier plug
Part of the adaptor which provides electrical connection between the humidifier and
the Adaptor.
PCB
Printed Circuit Board.
Thermistor
A temperature sensitive resistor placed inside the chamber probe.
ST310
Laparoscopic Humidification Kit.
RT350
Laparoscopic Humidified Insufflation Kit.
ST300
Open surgery Humidification Kit.
F&P HumiGard™ Surgical
Humidification System
MR860AEU Surgical Humidifier used with one of the consumable kits
(RT350, ST310, ST300) and a 900ST100 Adaptor.
3. Definitions
NOTE: A NOTE provides important information or explanation of procedures or conditions which may otherwise be
misinterpreted or overlooked.
PRECAUTION: A PRECAUTION statement designates the possibility of damage to this or other equipment if a procedure is
not followed exactly.
WARNING: A WARNING statement refers to conditions with a possibility of personal injury if a procedure is not followed
exactly.
4. Intended Use
For use in warming and humidifying surgical insufflation gas.
Laparoscopic Procedures
Intended for patients of all ages undergoing laparoscopic procedures where carbon dioxide (CO2) insufflation gas is used.
Open surgery Procedures
Intended for patients of all ages undergoing open abdominal or cardiothoracic surgical procedures where CO2 insufflation
gas is used.
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5. Warnings
5.1 General Warnings
• The ST310 Laparoscopic Humidification Kit, RT350 Humidified Insufflation Kit and the ST300 Open Surgery
Humidification Kit are intended for single use. Reuse may result in transmission of infectious substances,
interruption of treatment, serious harm or death. Incinerate consumables after use.
• To ensure sterility of the humidified insufflation tube, inspect sterile packaging for damage before use. Discard if
damaged.
• To avoid the risk of electric shock, this equipment must be connected to a mains supply with protective earth.
To avoid excess energy in the output gas do not:
• Use the system with preconditioned CO2 gas.
• Fill the humidification chamber with water in excess of 37 °C.
• Place surgical drapes over the humidified insufflation tube.
• Coil the humidified insufflation tube.
• Do not use gases other than CO2.
5.2 Warnings for Laparoscopic Procedures
• To prevent air embolism, purge the system of air using CO2 before insufflation.
• For safe and effective use do not exceed the insufflator maximum set flow rate (≤ 45 L/min).
• To avoid inaccurate pressure readings on the insufflator, ensure insufflators used are regularly serviced and/or
calibrated according to the manufacturer’s instructions.
5.2.1 ST310 Laparoscopic Humidification Kit Only
• To ensure stable and accurate pressure readings on the insufflator when using the Veress needle, ensure that the
humidification chamber is filled to the recommended water level ~ 180 mL.
5.2.2 RT350 Humidified Insufflation Kit Only
• To ensure stable and accurate pressure readings on the insufflator when using the Veress needle, use the Veress
bypass connector.
• To prevent any pressure fluctuations with the Conmed-Linvatec GS1002 insufflator, use conventional insufflation
tubing for initial creation of pneumoperitoneum when using the Veress needle.
5.3 Warnings For Open Procedures
• To ensure efficient de-airing of the wound only use the system with an approved gas diffuser. The VITA-diffuser™
manufactured by Cardia Innovation AB is approved for use with the ST300 Open Surgery Humidification Kit.
• For correct use of the VITA-diffuser™ refer to the VITA-diffuser™ Instructions for Use
(REF VdBXYYYYMM) or the CarbonVITA™ Instructions for Use (CVBXYYYMM).
• For safe and effective use do not exceed the maximum flow rate (≤ 15 L/min).
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6. General Precautions
To ensure patient safety, optimal therapy and performance:
• Only use accessories approved by Fisher & Paykel Healthcare.
• Do not use the serial port when the humidifier is in patient use as this may cause electromagnetic interference with
other equipment.
• Always disconnect the power supply before servicing. Failure to do so may compromise electrical safety.
• Do not touch the glass tip of the chamber probe or the heater-plate during use or directly after use as this may result
in minor skin burns.
• Do not use the 900ST100 Adaptor if there is visible damage to the adaptor as this may compromise system
performance.
• Do not use the humidification chamber if the seal is not intact or the humidification chamber has been dropped.
Broken seal or cracks may result in water and gas leaks.
• Mount the humidifier so that the heater-plate is on a horizontal plane to prevent water spillage.
• Do not obstruct ventilation slots on the humidifier as this may cause overheating.
• Ensure the 900ST100 Adaptor connectors are dry at all times. Failure to do so may damage the device.
• Operate the F&P HumiGard™ Surgical Humidification System within the recommended operating conditions.
• Connect to output of a source delivering CO2.
• Do not exceed the maximum set flow rate.
• Do not modify the humidifier or accessories.
• Do not use the humidifier in the vicinity of high-frequency surgical apparatus and shortwave or microwave
equipment which adversely affects the humidifier’s function. If this occurs, the humidifier should be removed from
the vicinity of such devices.
• Do not use excessive force when refastening screws and bolts which have been removed during servicing.
• Follow anti-static procedures when servicing this product.
• Fisher & Paykel Healthcare does not currently support connections to the Surgical Humidifier via the serial port for
data-logging purposes.
7. Symbol Definitions
Do not use if package is damaged
C-Tick for EMC
Use sterile water
Caution - Hot Surface
STANDBY/ON Button
Use only carbon dioxide gas
Resistant to vertical falling drips
Peel the sterile bag open in
direction indicated
Do not use oxygen gas
Fragile.
Handle With Care
Excess water in the chamber
Prior to gas flow,
Preheat mode will
heat the water
This Way Up
Correct water level in the chamber
Serial port
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8. Approved Accessories
Using non-approved accessories or spare parts could be unsafe.
Use only the following approved products from your Fisher & Paykel Healthcare supplier:
General Accessories
900ST100 Adaptor
900MR880 Reference Probe
Laparoscopic Accessories
ST310 Laparoscopic Humidification Kit
RT350 Humidified Insufflation Kit
Open Surgery Accessories
ST300 Open Surgery Humidification Kit
VITA-diffuser™ manufactured by Cardia Innovation AB
CarbonVITA™ manufactured by Cardia Innovation AB
VITA-diffuser™ and CarbonVITA™ are registered trademarks of Cardia Innovation AB
NOTE: Accessories may not be available in all countries. Contact your local Fisher & Paykel Healthcare office or distributor
for more information.
9. Device Description
F&P HumiGard™ Surgical Humidifier
Finger-guard:
Prevents touching the
hot heater-plate and
keeps chamber in place
MR860AEU
Temperature display:
Indicates the humidification chamber
outlet temperature when the
temperature display button is pressed
Temperature display
button:
Displays the temperature
on the temperature
display when pressed
Heater-plate:
Heats water to supply
heat and humidity to
the insufflation gas
Standby/ON button:
Toggles the heaterbase between ON and
Standby mode
Operational indicators:
Indicates incorrect
connections, humidity
level and hardware
faults
Adaptor port:
Attaches the adaptor to
the humidifier
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10. Accessory Description
10.1 900ST100 Adaptor
Heater-wire plug:
Provides electrical
connection from
the adaptor to the
humidified insufflation
tube heater wire
Chamber probe:
Measures the chamber
outlet temperature
and flow rate of gas
traveling through the
humidified insufflation
tube
Ambient sensor:
Measures ambient
temperature
Humidifier plug:
Provides electrical
connection between
the humidifier and the
adaptor
10.2 900MR880 Reference Probe
Black plug:
Used to complete
humidifier calibration
check number 2
Grey plug:
Used to complete
humidifier calibration
check number 1
NOTE:
The 900MR880 Reference Probe is to be replaced every three years. Please contact your Fisher & Paykel Healthcare
office or distributor to arrange for the replacement of the probe.
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11. Mode of Operation
The F&P HumiGard™ Surgical Humidification System is used to deliver humidified CO2 to patients undergoing laparoscopic
and open surgery. The gas is passed through a humidification chamber where it is warmed and humidified by the humidifier.
The temperature of the gas is then maintained as it travels along the humidified insufflation tube to the patient.
The F&P HumiGard™ Surgical Humidification System has two heating systems. The first is a heater-plate, which heats
the water contained in the humidification chamber, humidifying the CO2 passing through it. The humidifier monitors the
temperature of the CO2 at the chamber outlet with the chamber probe, and controls the amount of power delivered to the
heater-plate, to maintain the chamber set point. The second heating system is the heater-wire encapsulated within the
humidified insufflation tube. Humidified gas from the humidification chamber travels through the humidified insufflation
tube, where the temperature is maintained to prevent the generated humidity from condensing in the humidified insufflation
tube. The humidifier maintains the temperature along the humidified insufflation tube by controlling the power delivered to
the heater-wire.
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12 Specifications
12.1
F&P HumiGard™ Surgical Humidifier
Dimensions (without chamber fitted):
140 mm x 173 mm x 135 mm
Mass (without chamber fitted):
2.8 kg
Supply voltage:
230 V ~
Supply frequency:
50 Hz
Supply current:
1 A @ 230 V ~
Rated Input:
230 W
Heater-plate:
150 W
Heater-wire:
22 V ~, 60 W MAX
93/42/EEC Class IIb Medical Device
Recommended operating environment: 18 °C to 24 °C
IP rating:
IPX1
Humidity performance (0 to 10 L/min):
> 33 mg/L
Humidity (Min):
20% RH
Humidity (Max):
60% RH
Sound Pressure Level:
Audible tomes exceed 50 dBA @ 1 m
Transport and storage conditions:
-10 °C to +50 °C
Standards and approvals:
IEC 60601-1, EN 60601-1, IEC 60601-1-2
Heater-plate high temperature cut-out:
118 ± 6 °C
If you are considering operating the system outside the recommended temperature range first consult your local
Fisher & Paykel Healthcare office or distributor.
NOTE: This device is latex free.
DISPLAY
Three-digit 14 mm 7-segment LED
Display range:
10 °C to 70 °C
Display accuracy: (25 °C to 45 °C )
+/- 2 °C
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12.2
Laparoscopic Procedures – ST310 Laparoscopic Humidification Kit
Maximum gas pressure:
30 mmHg
Input set flow rate:
≤ 45 L/min
Maximum achieved flow rate:
15 L/min
Resistance to flow: @ 1 L/min
0.6 mmHg
@ 2 L/min
1.4 mmHg
@ 5 L/min
4.4 mmHg
Leakage (@ 30 mmHg):
< 50 mL/min
Warm-up time:
≤ 10 mins
Humidification chamber reservoir
~180 mL (Use sterile water)
Luer fittings conform to ISO 594-1:1986 and ISO 594-2:1998
12.3
Laparoscopic Procedures – RT350 Humidification Kit
Maximum gas pressure:
30 mmHg
Input set flow rate:
≤ 45 L/min
Maximum achieveable flow rate:
15 L/min
Resistance to flow: @ 1 L/min
0.5 mmHg
@ 2 L/min
1.2 mmHg
@ 5 L/min
3.9 mmHg
Leakage (@ 30 mmHg):
< 50 mL/min
Warm-up time:
≤ 10 mins
Humidification chamber reservoir
~30 mL (Use sterile water)
Luer fittings conform to ISO 594-1:1986 and ISO 594-2:1998
12.4
Open Procedures – ST300 Open Surgery Humidification Kit
Maximum achieved flow rate:
≤ 15 L/min
Maximum Input set flow rate:
≤ 15 L/min
Recommended flow rate
10 L/min
Warm-up time:
≤ 10 mins
Humidification chamber reservoir
~180 mL (Use sterile water)
Luer fittings conform to ISO 594-1:1986 and ISO 594-2:1998
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13. Maintenance Procedures
To keep the F&P HumiGard™ Surgical Humidification System in good working order, it is necessary for qualified service
personnel to perform maintenance at regular intervals. The maintenance schedule below is designed to ensure testing is
carried out on the various components of the F&P HumiGard™ Surgical Humidification System at appropriate intervals.
13.1 Maintenance Schedule
13.1.1 Surgical Humidifier
Annually:
a. Check the humidifier for physical damage:
• Check the mains cable for damage; replace if necessary.
• Check the heater-plate for deep scratching and damage; replace if necessary.
b. Carry out a full performance test. This procedure is detailed in Section 16 Performance Testing.
NOTE: A maintenance check sheet is given in Appendix A.
13.1.2 900ST100 Adaptor
Every six months:
a. Visually check the adaptor for physical damage:
1. Check that the chamber probe’s glass thermistor has not been damaged. Replace adaptor if required.
2. Inspect the chamber probe’s glass thermistor for deposits or foreign material. Clean the chamber probe as
required.
3. Check the adaptor cable for kinks and abrasions and damaged connectors.
4. Check that the adaptor’s connectors couple with the humidifier sockets.
b. Check the adaptor’s accuracy:
• Carry out a temperature accuracy test on the ambient sensor and chamber probe.
• Carry out a flow accuracy check on the chamber probe and humidifier.
• These tests are outlined in Section 16.2.
13.2 Safety Check
The humidifier should be tested to the current medical electrical standards for in-house testing for each specific country
(for example, refer to AS/NZS 3551 for Australia and New Zealand). If the humidifier is fitted with an Equipotential Stud on
the base, both the heater-plate and the Equipotential Stud should be tested for Earth Resistance.
NOTE: The correct ground test point location is on the heater-plate at the front underside edge, as shown in Figure 1,
where the insulating anodizing layer has been removed. Permanent damage to this humidifier will result if the serial port
is used as a ground point during electrical safety testing.
• If the heater base is fitted with an Equipotential Stud, this stud can be used as a ground test point as shown in Figure 2.
Figure 1 : Location of ground test point on the heater-plate
Figure 2: Location of ground test point on the earth stud
13.3 Cleaning Instructions
Refer to the Surgical Humidification System Instructions for Use (UI-185046315) for the humidifier’s cleaning
instructions or 900ST100 Adaptor Instructions for Use (UI-185046318) for the adaptor’s cleaning instructions.
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14. Troubleshooting & Front Panel Indicators
Symptom
Corrective Action
Reference
Hardware fault indicator on
Record the displayed error code.
Section 14.1
Hardware fault indicator on,
without an audible tone
1) There has been a microprocessor failure.
2) Replace the PCBs.
Section 15.2.2
Hardware fault indicator on
with an audible tone
1) Check that the mains supply is within specification. Provide adequate
mains supply if required. If the problem persists, refer to step 2.
2) Replace the PCBs.
Section 15.2.2
Heater-wire plug and
chamber probe indicator on
accompanied by an audible
tone
Section 15.2.2
1) Ensure that the humidifier is not in preheat mode.
2) Ensure that the adaptor is properly plugged into the humidified
insufflation tube. If the problem persists, refer to step 3.
3) Replace the humidified insufflation tube. Retest. If the problem persists,
refer to step 4.
4) Replace the adaptor, and check for intermittent connections. Retest. If the
problem persists, refer to step 5.
5) Replace the PCBs.
Adaptor plug indicator is on,
accompanied by an audible
tone occurring every 2 minutes
1) Ensure that that the adaptor is correctly plugged into the humidifier. If the
problem persists, refer to step 2.
Section 16.1.2
2) Perform a humidifier calibration check. If the problem persists, refer to
step 3.
3) Replace adaptor and re-test. If the alarm condition disappears, the
adaptor is faulty. Discard the faulty adaptor; otherwise refer to step 4.
Section 15.2.2
4) Replace the PCBs
Water indicator is on
1) Ensure that the humidification chamber has an appropriate level of water. Section 15.2.2
Fill the chamber with an adequate amount of water if required. If the
problem persists, refer to step 2.
2) Replace the PCBs.
Humidifier will not turn on with 1) Ensure that the humidifier is plugged into mains supply.
On/Standby button, and no
2) Check that the mains supply is within specification. Provide adequate
indicators are lit
mains supply if required. If the problem persists, refer to step 3.
3) Remove mains power and check the fuses. If the problem persists, refer
to step 4.
4) Check continuity of the mains power cord. Replace as necessary. If the
problem persists, refer to step 5.
5) Check the transformer windings are not open circuit.
• Primary Winding: Red wires
• Secondary 10 V winding: White wires
• Secondary 22 V winding: Yellow wires
• If any windings are open circuit, replace the transformer. If the problem
persists, refer to step 6.
6) Replace the PCBs.
Unit fails calibration check
Send the unit to a Fisher & Paykel Healthcare service representative for
calibration, or replace the PCBs.
Adaptor fails Accuracy Check
Replace the adaptor.
Unit fails to reach temperature
in heater control check
(Section 8.1.5)
1) If the chamber outlet temperature is low, the heater-plate element should
be checked. Replace the element as necessary. If the problem persists,
refer to step 2.
2) Replace the PCBs.
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Section 15.2.1
Section 15.2.6
Section 15.2.3
Section 15.2.2
Section 15.2.2
Section 15.2.4
Section 15.2.2
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Front Panel Indicators
Water indicator:
Indicates that no water
has been put in the
humidification chamber or
the water has run dry
Heater-wire Plug and
Chamber Probe Indicator:
Lights up when in preheat
mode, if the 900ST100
Adaptor is not inserted into
the humidified insufflation
tube, when the humidification
chamber temperature is being
displayed or if the 900ST100
Adaptor is faulty
ON indicator:
Solid light indicates that the
humidifier is on. Flashing light
indicates that the humidifier is
in preheat mode
Adaptor indicator:
Lights if the 900ST100 Adaptor
is not correctly plugged into the
humidifier or if the 900ST100
Adaptor is faulty
Hardware fault indicator:
The humidifier requires
servicing. Humidification will
not be delivered when this
indicator is illuminated.
For servicing refer to the MR860
Humidifier Technical Manual
(REF 1850436474)
Temperature display:
Indicates the humidification
chamber outlet temperature
when the temperature display
button is pressed
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14.1 “Hardware Fault” Error Codes
The following is an explanation of the error codes that are displayed in conjunction with the Hardware Fault indicator
flashing. A code is not displayed if the microprocessor has stopped functioning (see Troubleshooting - Section 14).
Instantly Latching
E01
No production test pass
E02
ROM checksum fault – corrupted software
E03
ROM version newer than that in EEPROM
E04
ROM version older than that in EEPROM
E05
Model number fault
E06
RAM stack overflow
E07
Display-temperature button stuck down
E08
On/Standby button stuck down
E09
EEPROM read/write fault
Transient Suppressed (must be present for > 7 seconds)
E10
Range-0 amplifier fault
E11
Range-1 amplifier fault
E12
Range-2 amplifier fault
E13
Range-3 amplifier fault
E14
Heater-wire triac open circuit
E15
Heater-wire triac short circuit
E16
Heater-wire relay short circuit
E17
Heater-plate thermistor short circuit
E18
Heater-plate thermistor open circuit
E19
Flow circuit fault
E20
Q17 open circuit
E21
Chamber to ambient thermistor short circuit
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15. Servicing Procedures
PRECAUTION: All servicing procedures should be followed by a humidifier performance test, and an electrical safety test to
ensure proper operation. The performance tests are outlined in Section 16.
15.1 Disassembly
15.1.1 Opening the case
1. Ensure mains power is disconnected from the unit.
2. Remove the four screws at the back of the humidifier.
3. Remove the front half of the case by sliding the two halves apart. Pull the front half of the case away from
the rear (Figure 3).
Figure 3: Removing the front half of the case
The control PCB is attached to the front half of the case. The PCB in the rear half of the case is the power PCB.
4. Slide the power PCB forward with the side panel (the side panel is attached to the power PCB). The side
panel will need to be pushed inwards during the sliding action in order to unlatch and clear the electrical
connector.
5. Unclip the three fasteners (Figure 4) which hold the front (control) PCB to the front of the case, and separate
the front PCB from the case.
Figure 4: PCB fasteners
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15.1.2 Closing the case
1. Make sure that all harnesses which were previously disconnected have been reconnected. If the mains
wiring was disconnected during servicing, check that the mains polarity is correct (see Section 15.2.6 for
mains cord polarity table).
2. Slide the power PCB back into position, ensuring that the side panel slides in the slots and latches into the
case rear.
3. Place the control PCB back into position in the front of the case, ensuring all clips are located properly.
4. Slide the case together, and replace the four screws.
5. In order to check that the humidifier is working properly, complete a full performance test as outlined in
Section 16.
15.2 Servicing
15.2.1 Replacing the fuses
1. Open the case (see Section 15.1.1).
2. The fuses can now be accessed (see Figure 5 for the location of the fuses on the power PCB).
Figure 5 : Location of the fuses on the power PCB
The four fuses have the following ratings:
Model Number
MR860AEU
Supply Voltage
Fuse Type
Part Number
F1: 1 A 250 V FastBlow
342042092
F2: 4 A 125 V FastBlow
342042093
F3: 2 A 250 V FastBlow
999 830 009
F4: 2 A 250 V FastBlow
999 830 009
230 V~
WARNING:
Be sure to replace the fuse with the correct rating and type. Do not under any
circumstances replace F2 with anything other than a fast blow fuse of the type and
rating specified, as serious injury could result.
3. Replace the fuse.
4. Close the case (Section 15.1.2).
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15.2.2 Replacement of Printed Circuit Boards
1. Open the case (Section 15.1.1).
2. Disconnect all harnesses attached to the power PCB. Disconnect the mains and protective earth wires by
unscrewing the terminal blocks, and cutting the cable ties (Figure 6).
3. Replace the PCBs. Note that the side panel (including the connector) is replaced, along with the power PCB.
4. Unpack the replacement PCBs, replace the mains fuses (F3, F4) with the correct type, and attach the mains
and protective earth wires, using the cable ties provided (Figure 6).
5. Connect the harnesses from the transformer and heater-plate to the power PCB.
6. Close the case (Section 15.1.2).
7. Update the EEPROM software version (Section 15.2.5).
8. Check that the humidifier powers up normally, and complete a full performance test (Section 16).
NOTE: Removal of the ribbon cables between the power PCB and control PCB will invalidate the calibration of
the unit. Do not separate the boards they must be replaced as a pair.
Figure 6: Humidifier power PCB wiring
15.2.3 Replacement of Transformer
1. Open the case (Section 15.1.1).
2. Disconnect the transformer’s primary and secondary harnesses attached to the power PCB.
3. Unscrew the four mounting screws fixing the transformer, and remove the transformer from the case.
4. Place the new transformer inside the case, and mount using the four screws.
5. Connect the transformer’s primary and secondary harnesses to the power PCB.
6. Close the case (Section 15.1.2).
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15.2.4 Servicing the heater-plate
Resetting the thermal cut-out
1. Open the case (Section 15.1.1).
2. Check the thermal cut-out on the heater-plate by pushing the red button with a pen or small screwdriver
(Figure 7).
Figure 7: Location of the thermal cut-out
3. If the thermal cut-out “clicks” when pushed, it has been previously activated, and is now reset.
NOTE: If the heater-plate is still hot, it must be allowed to cool sufficiently before the thermal cut-out will reset.
4. Close the case (Section 15.1.2).
Replacing the heater-plate thermistor
NOTE: A heater-plate thermistor service kit is required (Part Number: 043 041 254).
1. Open the case (Section 15.1.1).
2. Disconnect the heater-plate element, thermistor and thermal cut-out harnesses attached to the power PCB.
3. Remove the three screws holding the heater-plate (Figure 8).
Figure 8: Location of heater-plate screws
4. Cut the cable ties attached to the heater-plate harnesses.
5. Remove the screw holding heater-plate thermistor (Figure 9).
6. De-solder the wires attached to the thermal cut-out, and remove the old thermistor and harness.
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Figure 9: Location of heater-plate thermistor, thermal cut-out and element screws
7. Place the new thermistor into position, and attach using the screw.
8. Solder the wires from the new harness to the heater-plate thermal cut-out.
9. Attach the cable ties provided to the heater-plate harness.
10. Place the heater-plate back into position, ensuring the springs underneath the heater-plate are in place.
Attach to the humidifier’s case using the three long screws that were previously removed.
11. Connect the heater-plate element, thermistor and thermal cut-out harnesses to the power PCB.
12. Close the case (Section 15.1.2).
Checking the heater-plate element
1. Open the case (Section 15.1.1).
2. Disconnect the heater-plate element, thermistor and thermal cut-out harnesses from the power PCB.
3. Measure the resistance between the two contacts on the heater-plate element connector (this is the large
three-pin connector).
The resistance of the heater-plate element should measure the same, as outlined in the table below:
Model Number
MR860Axx
Supply Voltage
230 V~
Heater-plate Resistance
353 ± 12 Ohms
If the measured resistance is outside this range, replace the heater-plate element (steps 4 to 9). If the heaterplate element is within specification, go to step 10.
NOTE: If the heater-plate element requires replacing, a heater-plate element service kit is required - see
Section 18 : Heater-plate Assembly.
4. Remove the two visible screws holding the heater-plate element reflector. Remove the shield, making sure
the washers are not lost. Unscrew the last four screws on the element cover (Figure 9).
5. Remove the heater element, leaving the mica insulator in place.
6. Insert the new element into position, making sure the mica insulator is between the element and the heaterplate.
7. Replace the element cover, using the four screws that were previously removed.
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8. Replace the element reflector, ensuring the washers that separate the reflector from the cover are placed
back into position. Screw into place.
9. Place the heater-plate assembly back into position, making sure the springs underneath the heater-plate are
in place. Attach to the humidifier case using the three long screws that were previously removed.
10. Connect the heater-plate element, thermistor and thermal cut-out harnesses to the power PCB.
11. Close the case (Section 15.1.2).
Replacing the thermal cut-out
NOTE: A thermal cut-out service kit is required (Part Number: 349 040 052).
1. Open the case (Section 15.1.1).
2. Disconnect the heater-plate element, thermistor and thermal cut-out harnesses from the power PCB.
3. Remove the three screws holding the heater-plate (Figure 9).
4. De-solder the two black wires attached to the thermal cut-out.
5. Unscrew fasteners used to secure the thermal cut-out, and remove.
6. Place a new thermal cut-out in position and fasten using the screws provided.
7. Depress the thermal cut-out’s red button to ensure it is reset.
8. Solder the black wires that were previously disconnected to the contacts on the new thermal cut-out.
9. Place heater-plate back into position, ensuring the springs underneath the heater-plate are in place. Attach
to the humidifier’s case using the three long screws that were previously removed.
10. Connect the heater-plate element, thermistor and thermal cut-out harnesses to the power PCB.
11. Close the case (Section 15.1.2).
15.2.5 Installing new software
1. Open the case (Section 15.1.1).
2. Remove the ROM integrated circuit U3 (Figure 10) using the appropriate tools.
Figure 10: Location of U3 ROM
3. Place a new ROM into the empty socket, ensuring correct orientation.
4. Close the case (Section 15.1.2).
5. Apply mains power, press the On/Standby button to transfer the humidifier to On Mode, then press the
Temperature Display button when either “E03” or “E04” appears on the display. The humidifier will reset,
automatically updating the software version.
6. Check that the humidifier powers up normally, and complete a full performance test (Section 16).
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15.2.6 Replacing the mains cable
1. Open the case (Section 15.1.1).
2. Unscrew the three mains cable wires from the terminal blocks on the power PCB (Figure 6), and cut the cable
tie on the PCB.
3. Slide the mains cable retainer away from the rear of the case.
4. Replace the power cord, and affix to the case by forcefully pushing the retainer back into position (towards
the rear of the case).
5. Attach the three mains cable wires to the terminal blocks on the power PCB (see table below for correct
mains cable wiring), and attach the phase and neutral wires with a new cable tie.
CORD TYPE
PHASE
NEUTRAL
EARTH
NZ / AUSTRALIA(230 V)
Brown
Blue
Green / Yellow
U.K. (230 V)
Brown
Blue
Green / Yellow
European/IEC (230 V)
Brown
Blue
Green / Yellow
WARNING: When attaching the mains cable wires, ensure that the correct polarity
of the mains wiring is followed. The table above only applies to power cords
supplied by Fisher & Paykel Healthcare.
6. Close the case (Section 15.1.2).
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16 Performance Testing
This section discusses the performance testing of the Surgical Humidifier and also the adaptor. Performance testing is
required as part of ongoing maintenance or after servicing of the humidifier has been completed.
16.1
Surgical Humidifier Performance Testing
If the humidifier has been operating normally, but a performance check is required as part of the maintenance
schedule, it is recommended that the following tests be completed:
1. A humidifier calibration check (Section 16.1.2)
2. A humidifier display check (Section 16.1.4).
However, if there is a problem with the humidifier, or if the humidifier has recently been serviced, then the following
tests should be completed in addition to those outlined above.
3.
A humidifier performance and control check (Section 16.1.5).
16.1.1 Entering the service mode
The humidifier has a special mode which enables the operator to verify correct operation. To enter this mode, hold
down the On/Standby button on the front panel of the humidifier then apply mains power. The Hardware Fault
indicator will light up, and the humidifier will enter service mode. The service menu has four different tests:
Display
Description
Reference
-1-
Reference Probe Check
Section 16.1.2
-2-
Display Model and Software Version Number
Section 16.1.3
-3-
Adaptor Temperature Probe Check
Section 16.2.1
-4-
Display Test
Section 16.1.4
Pushing the Temperature Display button while a number is displayed enters the relevant service test. Service mode
exits automatically by resetting the heater-base after 30 minutes or can be exited manually or by cycling the power.
16.1.2 Humidifier Calibration Check
This section describes how to check the accuracy of the humidifier’s temperature and flow measurement electronics.
Equipment required
• Surgical Humidifier MR860AEU
• 900MR880 Reference Probe
1.
2.
3.
4.
Hold down the On/Standby button, then apply mains power to the humidifier. This action places the humidifier
into service mode.
Select service mode number 1 by pushing the Temperature Display button when ‘-1-’ is displayed.
Insert the grey plug of the Reference Probe into the adaptor port of the humidifier.
Allow the display to stabilize for a few seconds, and check the number shown on the humidifier display. The
table below shows the numbers displayed by the humidifier in this mode:
TEST
PASS
FAIL (LOW)
FAIL (HIGH)
Ambient Temperature
1.0
1.1
1.2
Chamber Temperature
1.0
1.3
1.4
Flow Temperature
1.0
1.5
1.6
If the humidifier displays any value other than ‘1.0’ or if the heater-wire plug and chamber probe indicator is on,
check that you have the correct calibration probe plugged in; otherwise the humidifier’s PCBs are faulty and need to
be replaced (see Section 15.2.2).
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5.
6.
7.
Press the Temperature Display button.
Insert the black plug of the Reference Probe into the adaptor port of the humidifier.
Allow the displayed value to stabilize for a few seconds. Check the humidifier display. The table below shows
the numbers displayed by the humidifier in this mode:
TEST
PASS
FAIL (LOW)
FAIL (HIGH)
Ambient Temperature
2.0
2.1
2.2
Chamber Temperature
2.0
2.3
2.4
Flow Temperature
2.0
2.5
2.6
TEST
Overheat
PASS
FAIL
2.0
Heater-wire plug and
chamber probe indicator
off
2.7
Heater-wire plug and chamber probe indicator on
If the humidifier displays any value other than ‘2.0’ or if the heater-wire plug and chamber probe indicator are on,
check that you have the correct end of the Reference Probe plugged in. Otherwise the humidifier’s PCBs are faulty
and will need to be replaced (see Section 15.2.2).
8. Remove the Reference Probe, and press the Temperature Display button to return to the service mode menu.
16.1.3 Humidifier Display Model and Software Version Number Check
1. Enter the service mode (Section 16.1.1).
2. Select service mode number 2 (Display Model and Software Version Number Check) by pushing the
Temperature Display button when ‘-2-’ is displayed.
3. Check that the humidifier displays its model number (860) on the seven-segment LED display.
4. Push the Temperature Display button and check that the humidifier displays the software version number
(3.0.2) on the seven-segment LED display.
16.1.4 Humidifier Display Test
This test is used to determine whether the humidifier’s display is working correctly.
1. Enter the service mode (Section 16.1.1).
2. Select service mode number 4 (display test) by pushing the Temperature Display button when ‘-4-’ is displayed.
3. Check that all of the display LEDs and indicators are turned on.
4. Check that the buzzer produced a single beep upon entering service mode number 4.
5. Push the Temperature Display button to exit back to return to the service mode menu.
If the humidifier does not pass the display test, then it is recommended that the humidifier’s PCBs be replaced
(Section 15.2.2).
16.1.5 Humidifier Performance and Control Check
This section describes how to check the humidifier’s heater control systems. This test should be performed if there is
a problem with the humidifier, or after servicing of the humidifier.
Equipment required
• Surgical Humidifier MR860AEU
• 900ST100 Adaptor
• Select one of the humidified kits (RT350, ST300, ST310) fill the chamber with water up to indicator line.
• Gas supply – CO2 insufflator (set to 2 ± 0.5 SLPM (Standard Litres per Minute)) or air supply at constant flow
of 2 ± 0.5 SLPM.
1. Make sure that the humidifier passes the calibration and display checks (refer Sections 16.1.2 and 16.1.4).
2. Set up the humidifier as shown in Instructions for Use. Make sure the chamber probe is correctly inserted.
3. Connect the humidifier chamber inlet to the 2 SLPM gas supply, and turn the humidifier on.
4. Wait approximately 15 minutes for the humidifier to stabilize.
Temperatures can be checked by using the temperature display mode.
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