ASTROPAD System Service Instructions Rev 12 March 2015

Contents 1 General ... 5 1.1 Important Safety information ... 5 1.1.1 Dangers ...5 1.1.2. Warnings ...5 1.1.3 Caution information ...6 1.1.4 Notices ...6 1.2 Technical service and spare part orders ... 7 1.3 Warranty terms ... 7 1.4 Before repairs ... 7 1.5 Repairs ... 7 1.6 Return of a used product ... 8 1.7 Disposal of the equipment ... 8 1.8 Symbols ... 8

2 Product description ... 10 2.1 Introduction... 10 2.2 Technical description ... 10 2.3 Components of ASTOPAD SYSTEM ... 11 2.4 Control panel components ... 12 2.5 Technical data ... 13 2.6 Circuit diagram ... 15 2.7 Description of the electronics ... 16 2.7.1 Summary ...16 2.7.2 Power supply ...16 2.7.3 Controller L (R) ...16 2.7.4 Automatic excessive temperature cut-out ...16 2.7.5 Broken wire alarm ...16 2.7.6 Monitoring heating resistance ...16 2.7.7 Alarms ...16

3.0 Cleaning and disinfecting ... 17 4.0 Function and safety check ... 18 4.1 Components System-Testbox... 18 4.2 Testing the ASTOPAD DUO120 control unit ... 19 4.2.1 Test mounting ...19 4.2.2 Testing equipment required ...19 4.2.3 Checking the display devices ...19 4.2.4 Testing the temperature display* ...19 4.2.5 Testing temperature control* ...20 4.2.6 Testing alarm cut-outs ...20 4.2.6.1 Testing excessive temperature bottom limit* ...20 4.2.6.2 Testing excessive temperature top limit* ...20 4.2.6.3 Testing the wire break alarm* ...20 4.2.6.4 Testing heating monitoring* ...21 4.2.6.5 Testing the power failure alarm ...21 4.2.6.6 Testing the time alarm* ...21 4.3 Testing the ASTOPAD COV/SOF heating element ... 22 4.3.1 Testing equipment required ...22 4.3.2 Testing sensor resistances (sensor test) ...22 4.3.3 Testing heating resistance ...22 4.4 Testing the ASTOPAD OPT 130 heating element... 23 4.4.1 Testing equipment required ...23 4.4.2 Testing sensor resistances (sensor test) ...23 4.4.3 Testing heating resistance ...23 4.4.4 Resistance between heating and the earth wire ...23 4.5 Specified values for sensor test ASTOPAD COV, SOF and OPT ... 24 4.6 Specified values for sensor test ASTOPAD COV, SOF and OPT ... 25 4.7 Electrical safety ... 27

ASTOPAD System Service Instructions

1 General

4.7.1 Testing equipment required ... 27 4.7.2 Earth wire resistance ... 27 4.7.3 Insulation resistance ... 27 4.7.4 Substitute earth leakage current ... 27 4.7.5 Substitute patient leakage current ... 27 4.7.6 Limit values electrical safety... 27

5.0 Troubleshooting ... 28 6.0 Repairing/replacing DUO120 control unit components ... 29 6.1 Dismantling, general ...29 6.2 Housing cover/replacing fuses and fuse pcb ... 31 6.3 Replacing the top part of the housing/operator board/relay board/mounting clamp ... 32 6.4 Replacing center part of housing ...34 6.5 Replacing the toroidal transformer ...35 6.6 Replacing bottom part of housing/device sockets/connecting board/klaxon/fuse board/housing cover ...36

7.0 Repairing the ASTOPAD COV heated blanket ... 37 7.1 Replacing the junction block ...37 7.2 Procedure ...37

8.0 Repairing the ASTOPAD OPT130 heatable pad ... 39 8.1 Replacing the junction block ...39 8.1.1 Description of junction block repair kit ... 39 8.1.2 Procedure ... 39

9.0 Repairing the ASTOPAD SOF heated mattress ... 40 10.0 Appendix A - Test protocols... 41 11.0 Appendix B - Spare parts list ... 48 12.0 Appendix C - Repair measuring devices ... 50

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1 General

ASTOPAD System Service Instructions

1 General 1.1 Important Safety information These servicing instruction define and refer to the following safety information.

DANGER Describes a maximum risk from a situation which, when not avoided, can lead directly to severe or fatal injuries.

WARNING Describes a dangerous situation which, when not avoided, can lead to severe or fatal injuries.

CAUTION Describes a dangerous situation which, when not avoided, can lead to mild to moderate injuries.

NOTICE Describes a warning relating to material damage.

1.1.1 Dangers DANGER Risk of electric shock! • • •

Live parts are exposed on the dismantled device during the various assembly tasks and tests. Always perform these tests whenever repairs have been performed and before use on the patient. All tests must be passed! If faults are found, the heating device must be repaired before being used on the patient. Faults which are not detected or eliminated may lead to death or serious injury, to damage to the device or to malfunctions.

DANGER Explosion hazard! Do not use the ASTOPAD SYSTEM patient warming system in an explosion-hazard environment or in the presence of flammable anaesthetics.

1.1.2. Warnings WARNING Risk of infection! Clean and disinfect the equipment after every use and before you return the equipment for repairs.

WARNING Danger of overheating! For infants and toddlers up to 90 cm in height, use only the applied parts ASTOPAD COV070 and ASTOPAD SOF7.

5

ASTOPAD System Service Instructions

1 General

1.1.3 Caution information CAUTION Risk of injury! • When installing the ASTOPAD DUO120 control unit on an infusion stand, observe the instructions from the infusion stand manufacturer regarding maximum load and overturning stability. • During the test the ASTOPAD COV/SOF/OPT heating element must not be in contact with patients

1.1.4 Notices NOTICE • The customer is responsible for the proper packaging and labelling of returns. • The specified defibrillation protection is ensured only when the applied part is connected to the extension connection cable and the control unit • Actions to avoid damaging the patient warming system: - Do not immerse the control unit and/or the connector for the connection cable in liquid. - Do not disinfect the system using steam (e.g., in autoclaves), hot air, or thermo-chemical cleaning solutions. • The operator should not use any cleaning or decontamination methods other than those recommended by the manufacturer. • During the complete test all overheating-protection systems and temperature regulators are cut out. Disregarding of the following security indications may lead to damages of the heating element. - The button POWER must remain pressed during the complete measurement. - The button POWER has a security function and shall never be set out of function. - During the complete test the operator has to be present. When making break during the test, the test box is to be removed. - In case the test box is connected to the control unit and POWER button is not pressed, then an alarm has to be triggered. If no alarm is triggered then the test box has to be removed immediately and has to be returned to Stihler Electronic. • The test heating resistance button may not be pressed for longer than 1 minute, otherwise the test resistor will overheat! • Before plugging in the test plug make sure the control unit is switched off ! • Test plug to be used solely to determine patient leakage current !

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1 General

ASTOPAD System Service Instructions

1.2 Technical service and spare part orders Germany STIHLER ELECTRONIC GmbH Julius-Hoelder-Strasse 36 70597 Stuttgart

Tel: +49-(0)711-72067-0 Fax: +49-(0)711-72067-57 e-mail: [email protected]

When making requests or ordering spare parts, please state the reference and serial number of the device in question. You can find them on the device rating plate:

1.3 Warranty terms The warranty period is 12 months. During the warranty period, the manufacturer will repair or exchange free of charge any defects attributable to faulty materials or workmanship. Other damage is not subject to this warranty. There is no claim under warranty in the event of misuse or incorrect handling, use of force or in the event of damage attributable to normal wear and tear. This applies equally to interference by persons not so authorized by the manufacturer or in the event of modifications to the original state. In the event of damage during the warranty period, return the cleaned device to your nearest sales outlet or direct to STIHLER ELECTRONIC GmbH. The sender is to bear any transport or packing costs incurred.

1.4 Before repairs The heating device may only be repaired by STIHLER ELECTRONIC GmbH or by service engineers expressly authorized by the manufacturer. STIHLER ELECTRONIC GmbH accepts no liability for the reliability, function and safety of the device if: • modifications or repairs are performed by unauthorized staff. • non-original spare parts are used. • the device is not used in accordance with the operating instructions. • the device is operated in an environment which does not conform to the applicable technical rules.

1.5 Repairs Proper records are to be kept of all repair activities, tests performed and the results. DANGER Risk of electric shock! Live parts are exposed on the dismantled device during the various assembly tasks and tests. Any change to its original state means that the device loses its certification, which is why only original ASTOPAD System spare parts should be used. Due to the safety risk, electronics boards may only be repaired by the manufacturer. They must be replaced in the event of faults.

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ASTOPAD System Service Instructions

1 General

1.6 Return of a used product A report must be sent together with the equipment, detailing the precise reasons, circumstances, and, if known, the cause of the return. To prevent transportation damage, the equipment should be shipped either in the original packaging or in other, well-protected packaging.

WARNING Risk of infection! Clean and disinfect the equipment after every use and before you return the equipment for repairs.

NOTICE The customer is responsible for the proper packaging and labelling of returns.

1.7 Disposal of the equipment Electrical devices are recoverable waste and should not be disposed of in domestic waste at the end of their service life. Please follow the local rules for the disposal of used products, or send the cleaned and disinfected equipment with a corresponding note to STIHLER ELECTRONIC GmbH or your closest sales point. This will ensure the most cost efficient and proper disposal of your old equipment. Follow the national regulations on the disposal of medical products.

1.8 Symbols Where applicable, these symbols appear at the appropriate location on the patient warming system, on the packaging, on the identification plate, and in the accompanying documentation. Defibrillation protected applied part type BF in accordance with IEC/EN 60601-1 IPX 1

Protected against falling water in accordance with IEC/EN 60529 (control unit)

IPX 2

Protected against falling water in accordance with IEC/EN 60529 (applied parts) Observe the instructions for use. General warning/danger symbol

REF

Reference (part) number

SN

Serial number Alarm condition when yellow LED flashes OFF position of the mains switch ON position of the mains switch “Start” key: starts the heating process Temperature increase set value Temperature decrease set value Switches off the power failure alarm using the (only acoustic alarm switches off) Year of manufacture Manufacturer

8

key.

1 General

ASTOPAD System Service Instructions

“SET” key: saves a new initial set temperature “Stop” key Margins of the heated area Symbol on plug connector for potential equalisation in accordance with IEC/EN 60601-1 Electrical devices are recoverable waste and should not be disposed of in domestic waste at the end of their service life. Dry at low heat Boil-proof, delicate wash cycle Do not use chlorine bleach Do not iron Dry-cleaning possible, limited to mechanical stress This device conforms to EC Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. The notified body, DEKRA Certification GmbH (registration number 0124), monitors the manufacturer’s quality management system. Additional information Tilt of the OR table top Acoustic alarm No acoustic alarm Notice for the position of the locking ring on the cable plug of the extension connection cable Symbol for the permitted temperature range for storage and transport Symbol for the permitted moisture range for storage and transport Symbol for the permitted atmospheric pressure range for storage and transport Transport with the arrows pointing up Keep dry Fragile, protect against impacts

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ASTOPAD System Service Instructions

2 Product description

2 Product description 2.1 Introduction ASTOPAD SYSTEM is the flexible and universal dry warming system for the operative, intensive care, and inpatient medical field. ASTOPAD SYSTEM consists of a control unit, which can be used to operate one or two applied parts independently of one another. While the applied parts ASTOPAD COV070/COV150/COV180/COV235 can be used as a top blanket or under-blanket, the applied part ASTOPAD COV155 is intended specifically for covering the patient’s upper body. All ASTOPAD SYSTEM applied parts can have direct skin contact (injured/uninjured skin) with the patient or are operated with an intermediate layer between the part and the patient.

WARNING Danger of overheating! For infants and toddlers up to 90 cm in height, use only the applied parts ASTOPAD COV070 and ASTOPAD SOF7. The ASTOPAD SOF applied parts provide the best prophylaxis against decubitus ulcers thanks to the use of visco-elastic foam. The integrated heater provides the patient with additional warmth via the mattress and thus plays an important role in hypothermia prophylaxis. All ASTOPAD SOF applied parts are equipped with an antistatic cover.The ASTOPAD DUO120 control unit is used to control and monitor the contact surface temperature of the ASTOPAD SYSTEM applied parts. Contra-indications ASTOPAD SYSTEM is not intended for use in incubators, homecare, or veterinary medicine.

2.2 Technical description ASTOPAD DUO120 is the control unit for ASTOPAD SYSTEM and is equipped with a universal attachment clip for attaching to an infusion stand.

CAUTION Risk of injury! When installing the ASTOPAD DUO120 control unit on an infusion stand, observe the instructions from the infusion stand manufacturer regarding maximum load and overturning stability. The ASTOPAD DUO120 control unit has two outputs (device boxes) A and B (Fig. 1) for connecting ASTOPAD SYSTEM applied parts. The required temperature of the respective applied part can be selected in a range from 32.0 °C to 39.0 °C in 0.5 °C increments on the control panel of the control unit. Outputs A + B can be set and operated independently of one another. Optionally, the system can also be operated with only one of the outputs A or B occupied. The temperature for each output, A or B, is selected on the part of the control panel located above each output. The selected temperature for each output is shown individually in small font at the bottom of the control panel, and the actual current temperature of the applied part is displayed in large numbers above this. The ASTOPAD SYSTEM applied parts consist of an x-ray-permeable, highly flexible heating element, which is supplied with 24-volt extra-low voltage heating current from the control unit. The temperature is controlled by eight sensors attached to heating element. The ASTOPAD COV applied parts can be used as a top blanket for warming the patient from above and/or as an under-blanket for warming the patient from underneath. ASTOPAD SYSTEM can be used in rooms designated for medical purposes, such as the operating room, intensive care unit, anaesthetic recovery room, and patient room, in which there is a risk of patient cooling or when patients should be exposed to external heat. Together with the pressure-relieving gel pad ASTOGEL, the ASTOPAD COV applied part plays an important role in the prevention of hypothermia and decubitus prophylaxis in surgical scenarios. When placed on top of the ASTOGEL gel pad, ASTOPAD COV prevents patient cooling from a cold gel pad, and the heat generated will be conveyed to the patient directly after heating starts. A long warm-up time for the ASTOGEL gel pad is not needed. However, it should be noted that only a 10

2 Product description

ASTOPAD System Service Instructions

combination of ASTOPAD COV and ASTOGEL is permitted. The contact surface temperature can be set from 32.0 °C to 39.0 °C in increments of 0.5 °C. The safety of ASTOPAD SYSTEM and its applied parts is guaranteed by the following measures: • 8 temperature sensors • 2 independent overheating shut-offs • Cable breakage alarm • 2 independent time shut-offs • Optical and acoustic alarm signals • Overheating and low-temperature alarm if the contact surface temperature deviates from the temperature controller setting • Power failure alarm The heating-up period from 23.0 °C to a contact surface temperature of 37.0 °C for ASTOPAD SYSTEM applied parts is approximately 10 minutes.

2.3 Components of ASTOPAD SYSTEM

Fig. 1 Components of ASTOPAD SYSTEM

No. Designation

Description For safely attaching the ASTOPAD DUO120 control unit to an infusion stand Operating keys and temperature displays

1

Attachment clip

2

Control panel

3

For switching on and off the control unit

6

Mains switch Output A (device box) Output B (device box) ASTOPAD COV

7

ASTOPAD SOF

Example of an ASTOPAD SOF applied part

8

Connection cable

9

End cap

Connection cable for connecting to the extension connection cable The attached end cap is used to close off the end when an extension cable is not connected. It protects the contacts and guarantees the IPX2 moisture resistance. The extension connection cable is used to connect the ASTOPAD COV and SOF applied parts to the control unit. Example of an ASTOPAD OPT130 applied part

4 5

10 11

Extension connection cable ASTOPAD OPT130

Plug connection between control unit and applied part Example of an ASTOPAD COV applied part

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ASTOPAD System Service Instructions

2 Product description

2.4 Control panel components

Fig. 2 Control panel components

No. Designation Actual temperature 1 A and B Set temperature 2 A and B 3

4

5 6 7 8 9

12

“Start” key A and B “Temperature increase” key A and B “Temperature decrease” key A and B “Start” LED (green) A and B “SET” key “Alarm” LED (yellow) “Alarm” LED (rot) “Stop” key A and B

Description Displays the actual temperature of the applied part Displays the selected set temperature of the applied part Press this key to start the heating process. OR Press this key to confirm a change made to the set temperature. Press this key to increase the set temperature in increments of 0.5 °C. You must press the “Start” key to confirm any new set temperature value you select. Press this key to decrease the set temperature in increments of 0.5 °C. You must press the “Start” key to confirm any new set temperature value you select. LED flashes when the heating process has not yet started. LED is solid when the heating process has started. Key for saving a new initial set temperature LED flashes and the acoustic alarm signal sounds when there is an alarm situation. Ends the heating process and switches off the respective output. Stop A cancels the power failure alarm!

2 Product description

ASTOPAD System Service Instructions

2.5 Technical data Control unit ASTOPAD DUO120.. Electrical connection Rated current Primary fuses Power consumption Classification (IEC/EN 60529) Classification (IEC/EN 60601-1) Classification (MDD 93/42/EEC) Code UMDNS Dimensions Height Width Depth Weight Operating mode Permissible ambient conditions In operation

During storage

Control of contact surface temperature Contact surface temperature display precision Overheating shut-off Acoustic alarm volume level

..EU/..EU-PA/..CH/ ..DK/..CN/..UK/..AU 230/240 VAC 50 – 60 Hz 0.8A 2 x T4.0 A

..EU110 110/120 VAC 50 – 60 Hz 1.6A 2 x T8.0 A 200 W IPX1

Protection Class I, defibrillation-protected applied part type BF Class IIb 11-989 260 mm 180 mm 210 mm 4.2 kg Continuous operation Atmospheric pressure 700 hPa 20% to 85% +10 °C to +40 °C to non-condensing 1060 hPa 500 hPa 20% to 90% -20 °C to +60 °C to non-condensing 1060 hPa 32.0 °C to 39.0 °C in 0.5 °C increments Tolerance ± 1.0 °C 32.0 °C to 39.0 °C in 0.5 °C increments Tolerance ± 0.7 °C 41.0 °C (± 0.5 °C) Approx. 65 dB(A) Moisture

Temperature

Combination possibilities for control unit/applied part COV150/COV180/ COV070/COV105/COV155/ Serial number of control unit SOF5 COV235/SOF2/SOF4/SOF7 ADxxxxx Possible Not possible AExxxxx Possible Possible AFxxxxx Possible Possible ASTOPAD blanket Electrical connection Power consumption Classification (IEC/EN 60529) Dimensions (mm) Length Width Height Weight (kg) Operating mode Permissible ambient conditions In operation

COV 070

COV 105

COV COV 150 155 24 VAC 115 W 150 W IPX2

60 W

680 500 30 0.7

1050 500 30 1.1

During storage

Temperature

20% to 85%

+10 °C to +40 °C

20% to 90% non-condensing

85 W

1500 1500 500 500 30 30 1.4 1.3 Continuous operation

Moisture non-condensing

COV 180

-20 °C to +60 °C

1800 800 30 2.2

COV 235 150 W

2050 1350 30 3.6

Atmospheric pressure 700 hPa to 1060 hPa 500 hPa to 1060 hPa 13

ASTOPAD System Service Instructions

2 Product description

ASTOPAD blanket Time to heat from 23.0 °C to 37.0 °C Connection cable Extension connection cable ASTOPAD pad/mattress Electrical connection Power consumption Classification (IEC/EN 60529) Dimensions (mm) Length Width Height Weight (kg) Operating mode Permissible ambient conditions

COV 070

COV 105

COV 150

COV 155

COV 180

COV 235

Approx. 10 minutes Approx. 50-cm PVC cable 2 m, 4 m, 6 m SOF 2

SOF 4

SOF 5

SOF 7

150 W

60 W

24 VAC 105 W

115 W IPX2

1800-2200 500-550 40-100 Approx. 7.5

In operation During storage Time to heat from 23.0 °C to 37.0 °C Connection cable Extension connection cable

900-1100 1350-1600 600-800 500-550 500-550 450-500 40-100 40-100 40-100 Approx. 2.7 Approx. 3.2 Approx. 2.0 Continuous operation Atmospheric Moisture Temperature pressure 700 hPa to 20% to 85% +10 °C to +40 °C non-condensing 1060 hPa 500 hPa to 20% to 90% -20 °C to +60 °C non-condensing 1060 hPa Approx. 10 minutes Approx. 50-cm PVC cable 2 m, 4 m, 6 m

ASTOPAD pad Electrical connection Power consumption Classification (IEC/EN 60529) Dimensions (mm) Length Width Height Weight (kg) Operating mode Time to heat from 23.0 °C to 37.0 °C Connection cable

OPT130 24 VAC 150 W IPX2 1050 500 30 Approx 5,2 Continuous operation Approx. 10 minutes Approx. 2,50-m PVC cable

NOTICE The specified defibrillation protection is ensured only when the applied part is connected to the extension connection cable and the control unit.

DANGER Explosion hazard! Do not use the ASTOPAD SYSTEM patient warming system in an explosion-hazard environment or in the presence of flammable anaesthetics.

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2 Product description

ASTOPAD System Service Instructions

2.6 Circuit diagram

15

ASTOPAD System Service Instructions

2 Product description

2.7 Description of the electronics 2.7.1 Summary The control unit has microprocessor-controlled operator guidance, a temperature controller and 2 redundant safety cut-outs independent of the controller, as well as a visual and an acoustic alarm which continue to operate even in the event of a power failure. Each applied part has a heating system and 8 sensors distributed evenly across its surface. The sensors are divided into two groups of 4 to create a redundant system. There are two of every part in the device, allowing 2 applied parts to be operated simultaneously.

2.7.2 Power supply The applied part is supplied with power by a transformer with safe segregation from the mains supply and protective low voltage of 24 V. For temperature control, the voltage is switched by AC switches L (R) and alarm relays K1 and K2.

2.7.3 Controller L (R) The controller controls the AC switches L (R) in such a way that the temperature of the warmest of the 8 sensors is controlled to specified temperature. Specified temperature itself is specified to the controller by the microprocessor, though the microprocessor can only specify nominal temperature within specific limits between a minimum and a maximum.

2.7.4 Automatic excessive temperature cut-out Two independent (redundant) cut-outs ensure that in the event of any fault, the device goes into a safe state and an alarm is triggered. Sensors 1 - 4 L (R) and 5 - 8 L (R) are each combined to form a group, ABS1 or ABS2 respectively. If at least one sensor reaches the permissible temperature for the alarm cut-out, relay K1 or K2 is switched off. A so-called seal-in circuit means that if one relay is triggered, the second automatically drops out too. Once the alarm has been triggered, the device remains in this condition. The operator has to reset the alarm manually by pressing the Start key.

2.7.5 Broken wire alarm The sensor cables are monitored for any of the connecting cables breaking. If the safety device detects too great a sensor resistance, the device is switched off as in the case of excessive temperature. As long as the side L or R in question has not been started, this function is suppressed so that the control unit can also be operated with one applied part.

2.7.6 Monitoring heating resistance If heating resistance is increased by a fault in the applied part (cut in the pad), this could lead to local overheating. Monitoring the resistance of the heating system automatically switches the system off if heating resistance exceeds a specific value.

2.7.7 Alarms In all cases in which the relays are switched off due to a fault condition, and when switching on, a visual and an acoustic alarm are triggered. In the event of a mains failure, this alarm is likewise triggered and remains active for approx. 10 minutes. This alarm is also triggered when the device is switched off. This alarm can be turned off using the left-hand Stop key.

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3.0 Cleaning and disinfecting

ASTOPAD System Service Instructions

3.0 Cleaning and disinfecting NOTICE Actions to avoid damaging the patient warming system: - Do not immerse the control unit and/or the connector for the connection cable in liquid. - Do not disinfect the system using steam (e.g., in autoclaves), hot air, or thermo-chemical cleaning solutions. Clean and disinfect by wiping the control unit and applied parts as needed, or follow the procedure below to clean any contamination from the equipment. 1. Disconnect the mains plug from the plughole. 2. Use the attached end cap to close off the cable plug of the applied part to ensure moisture resistance. 3. Clean all surfaces with a soft cloth and mild soap solution. 4. Disinfect the control unit and the applied parts using one of the following: • A ready-to-use disinfectant • An alcohol-based disinfectant with low levels of aldehyde (< 0.2%) List of approved, ready-to-use disinfectants: Disinfectant acryl-des ANIOSURF CITRON Bacillol Plus BIGUAMED PERFEKT N ClearSurf Mikrobac forte mirkrozid sensitive liquid Terralin protect Incidin Plus

Manufacturer Schülke + Mayr, Austria Laboratoires ANIOS, France BODE CHEMIE HAMBURG, Germany Desomed-Dr. Trippen GmbH, Germany Fresenius Medical Care, Germany BODE CHEMIE HAMBURG, Germany Schülke + Mayr, Germany Schülke + Mayr, Germany Ecolab GmbH, Germany

Follow the specific instructions for use.

NOTICE The operator should not use any cleaning or decontamination methods other than those recommended by the manufacturer.

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ASTOPAD System Service Instructions

4.0 Function and safety check

4.0 Function and safety check A check needs to be performed after any repair work to ensure perfect function, performance and safety; this check consists of the following tests (it is also recommended that these tests be performed before repairs to assist troubleshooting):

• • • •

visual check temperature control and accuracy of display alarm test electrical safety test

DANGER Risk of electric shock! • Always perform these tests whenever repairs have been performed and before use on the patient. • All tests must be passed! If faults are found, the heating device must be repaired before being used on the patient. Faults which are not detected or eliminated may lead to death or serious injury, to damage to the device or to malfunctions. Im Folgenden finden Sie die Anweisungen zur Durchführung der einzelnen Tests mit der SystemTestbox.

4.1 Components System-Testbox 1

2

3

4

5 7 6

1

Test button for wire break alarm (TDBRA)

5

Test button for excessive temperature top limit

2

6

3

Test button for temperature display Test button for temperature control

Check display for heating Knob for selecting individual sensors

4

Test button for excessive temperature bottom limit

7

14

13

8

9

10

11 12

8

Test buttons for heating monitoring

11

Connecting cable for control unit

9

Test socket for heating resistance Test socket for measuring resistance between heating and earth wire

12

Test socket for sensor resistance Connecting socket for heating element Test button for POWER

10

18

13 14

4.0 Function and safety check

ASTOPAD System Service Instructions

4.2 Testing the ASTOPAD DUO120 control unit Each of the sensors located in the applied part must be capable of assuming temperature control of the control unit and of displaying current actual temperature by means of actual resistance. The individual sensors are addressed and the relevant operating state simulated by the selector switch being in the relevant position and the individual test buttons on the system test box being pressed. The tests marked * are to be performed in identical fashion for both Channel A and Channel B.

NOTICE During the complete test all overheating-protection systems and temperature regulators are cut out. Disregarding of the following security indications may lead to damages of the heating element. • The button POWER must remain pressed during the complete measurement. • The button POWER has a security function and shall never be set out of function. • During the complete test the operator has to be present. When making break during the test, the test box is to be removed. • In case the test box is connected to the control unit and POWER button is not pressed, then an alarm has to be triggered. If no alarm is triggered then the test box has to be removed immediately and has to be returned to Stihler Electronic.

WARNING Risk of injury! During the test the ASTOPAD COV/SOF/OPT heating element must not be in contact with patients

4.2.1 Test mounting ASTOPAD DUO120 Control Unit

System test box

ASTOPAD COV/SOF/OPT Heating element

4.2.2 Testing equipment required • System test box for the ASTOPAD system

4.2.3 Checking the display devices Before start of the control unit the button POWER of the system test box must be pressed and this may not be unleashed up till the end of the test any more. When the device is switched on, the LED on the power button lights green and all the segments of the display should come on briefly. During an alarm state, the display should be backlit in yellow or red. After starting, the display should be backlit in green.

4.2.4 Testing the temperature display* • • • •

Button Power keep pressed. Start control unit at a specified temperature of 36 °C. Set knob on the system test box to 1. To test the temperature display, press test button TRU. 36 °C should now be shown in the display for actual temperature. The permitted tolerance range is ±0.5 °C. • Release test button TRU. • Repeat the test for the remaining sensors (2 - 8), increasing knob one value each time.

____________________________________________ * The tests marked * are to be performed in identical fashion for both Channel A and Channel B.

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ASTOPAD System Service Instructions

4.0 Function and safety check

4.2.5 Testing temperature control* • • • • • • • •

Button Power keep pressed. Start control unit at a specified temperature of 36 °C. Set knob on the system test box to 1. To test temperature control, press test button TRO. Heating LED turns off. Release test button TRO. Press the button "Start" at the ASTOPAD DUO control unit. Wait until heating LED turns ON. Repeat the test for the remaining sensors (2 - 8), increasing knob one value each time.

4.2.6 Testing alarm cut-outs 4.2.6.1 Testing excessive temperature bottom limit*

• • • • • • •

This test must be carried out only for control units on which the serial number begins with AD or AE! Button Power keep pressed. Start control unit at a specified temperature of 36 °C. Set knob on the system test box to 1. To test excessive temperature bottom limit, press test button TABSU. The acoustic alarm on the control unit may not be triggered. The display must show min. 40,5°C ±0,3 °C and the value “A2”. Heating LED turns off. Release test button TABSU. Wait until heating LED turns ON. Repeat the test for the remaining sensors (2 - 8), increasing knob one value each time.

4.2.6.2 Testing excessive temperature top limit* • • • • • • • • •

Button Power keep pressed. Start control unit at a specified temperature of 36 °C. Set knob on the system test box to 1. To test excessive temperature top limit, press test button TABSO. The acoustic alarm on the control unit must be triggered, the LED on the alarm display must flash "yellow" or "red", the value “L” must be shown in the display and the display must be backlit in "yellow" or "red". If the button TABSO be pressed, it must be shown min. 42,1°C. Heating LED turns off. Release test button TABSO. Press the button "Start" at the ASTOPAD DUO control unit. Wait until heating LED turns ON. Repeat the test for the remaining sensors (2 - 8), increasing knob one value each time.

4.2.6.3 Testing the wire break alarm* • • • • • • • •

Button Power keep pressed. Start control unit at a specified temperature of 36 °C. Set knob on the system test box to 1. Press the wire break test button TDBRA for Sensor 1. The alarm must be triggered, the display must be backlit "yellow" or "red" and the acoustic alarm should sound. Heating LED turns off. Release test button TDBRA. Press the button "Start" at the ASTOPAD DUO control unit. Wait until heating LED turns ON. Repeat the test for the remaining sensors (2 – 8). Press corresponding TDBRA button.

____________________________________________ * The tests marked * are to be performed in identical fashion for both Channel A and Channel B.

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4.0 Function and safety check

ASTOPAD System Service Instructions

4.2.6.4 Testing heating monitoring* • • • •

Button Power keep pressed. Start control unit at a specified temperature of 36 °C. The LED for heating must be on. Press the test heating resistance test button on the rear of the system test box. The alarm must be triggered after a few seconds.

NOTICE The test heating resistance button may not be pressed for longer than 1 minute, otherwise the test resistor will overheat!

4.2.6.5 Testing the power failure alarm • • • • •

Button Power keep pressed. Control unit must be in operation for at least five minutes. Switch off the control unit at the mains switch. The "yellow" or "red" alarm LED and the acoustic alarm must go on and off at intervals. The alarm is interrupted if the STOP A key is pressed.

4.2.6.6 Testing the time alarm* (test to be performed every 24 months!) • • • • •

Button Power keep pressed. Connect system test box to the control unit. Start control unit at a specified temperature of 36 °C. Then press the and keys simultaneously. After approx. 90 sec., the acoustic alarm should be triggered and should be shown in the display alternating with actual temperature display A3.

This type of testing is only possible for ASTOPAD DUO120 control units with serial numbers starting with AE/AF and/or control units of software version 230204.The software version can be called up by pressing the button of channel B and switching on the main switch. The current software status is shown instead of the actual temperature. If this is not the case, the time alarm can only be tested with the heatable ASTOPAD OPT130 operating table pad! Simultaneously pressing the and buttons is not necessary in this case. The control unit is started; after approx. 60 minutes the acoustic alarm should be triggered and shown in the display, alternating with the actual temperature display A3.

____________________________________________

* The tests marked * are to be performed in identical fashion for both Channel A and Channel B.

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