Test Instructions and Service Card
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Test instructions / Service Card IPM-L
42360
Evita V800 / V600
Revision 4.0
Evita V800 / V600 Table of contents
1 1.1 1.2 2 2.1 2.2
2.3 3 3.1
3.2
4 4.1
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Basic safety information 6 Complying with the documentation ... 6 Oxygen fire... 6 Service ... 6 Test instructions ... 6 General information 7 Device configuration 7 Serial numbers... 7 Software version ... 9 Maintenance parts 9 Maintenance intervals, overview... 9 2.1.1 Maintenance intervals and required sets and parts ... 9 Maintenance parts by specified interval... 10 2.2.1 Ventilation unit, internal battery M7 ... 10 2.2.2 Ventilation unit, particle filter (O2 filter) ... 11 2.2.3 Ventilation unit, Air filter (medical compressed air filter) ... 11 2.2.4 (Option) GS500, room air filter (filter mat) ... 11 2.2.5 (Option) GS500, air filter blower unit (microfilter) ... 11 2.2.6 (Option) PS500, battery set PS500 (Service) 15Ah ... 11 2.2.7 (Option) PS500, battery set PS500 (Service) 24Ah ... 12 2.2.8 (Option) Medication nebulizer, pressure regulator (O2-side)... 12 Maintenance parts as required ... 12 Electrical safety 13 Electrical safety according to IEC 62353 ... 13 3.1.1 Visual inspection... 13 3.1.2 Protective earth resistance ... 14 3.1.3 Protective earth resistance measuring points... 15 3.1.4 Test adapters for equipment leakage current ... 15 3.1.5 Device leakage current ... 15 3.1.6 Applied parts for leakage current from applied part test ... 16 3.1.7 Applied part leakage current, mains on applied part, type BF ... 16 Electrical safety according to IEC 60601-1 ... 17 3.2.1 Visual inspection... 17 3.2.2 Protective earth resistance ... 18 3.2.3 Earth leakage current medical device ... 19 3.2.4 Patient leakage current... 19 Function and condition test 21 General condition check ... 21 4.1.1 Medical device ... 21 4.1.2 Accompanying documents ... 21 4.1.3 Medical devices book ... 21 4.1.4 Rating plates, labels and notices on the medical device ... 21 4.1.5 Rating plates, labels and notices on the installed options ... 23 4.1.6 Control unit ... 24 Test instructions / Service Card IPM-L
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Table of contents
Evita V800 / V600 Table of contents
4.2
4.3
4.4 4.5
4.6
No.2201_0000011578
4.7
4.8
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4.1.7 Ventilation unit ... Condition test, options ... 4.2.1 (Option) MCable Mainstream CO2 module M11.1 (CO2 sensor)... 4.2.2 (Option) Neonatal flow measurement... 4.2.3 (Option) medication nebulizer (white housing) ... 4.2.4 (Option) Trolley... 4.2.5 (Option) Gas cylinder holder ... 4.2.6 (Option) Hose holder ... 4.2.7 (Option) GS500 ... 4.2.8 (Option) PS500... 4.2.9 (Option) Cable duct ... Fuse rating and readout of software version and operating data ... 4.3.1 Fuse value... 4.3.2 Software version... 4.3.3 Batteries ... Preparations for the function tests ... Control unit ... 4.5.1 Acoustic alarm... 4.5.2 Optical alarms ... 4.5.3 Rotary encoder lighting ... Ventilation unit module M1.3 (gas delivery module) ... 4.6.1 Self-tests of the ventilation unit ... 4.6.2 Zeroing all flow sensors... 4.6.3 Relative flow difference S2/S3 ... 4.6.4 Relative flow difference S1/S3 ... 4.6.5 Leakage LPSV V3 ... 4.6.6 Valve calibration for workstations with gas supply unit GS500 ... 4.6.7 Comparator shut-off pressure ... 4.6.8 Comparator switch-on pressure ... 4.6.9 Proportional valve AIR 120 L/min ... 4.6.10 Proportional valve AIR 5 L/min ... 4.6.11 Proportional valve O2 120 L/min ... 4.6.12 Proportional valve O2 5 L/min ... 4.6.13 "System Leakage Test (M1V3)"... 4.6.14 Leakage, AIR proportional valve ... 4.6.15 Leakage, O2 pipeline supply non-return valve ... 4.6.16 Leakage, O2 proportional valve ... 4.6.17 Leakage, AIR pipeline supply non-return valve ... 4.6.18 Comparative pressure measurement, Ptank and inspiratory pressure sensor ... 4.6.19 Comparative flow measurement M1.3... Ventilation unit module M12.4 (Pato, standalone) ... 4.7.1 Calibration ... 4.7.2 Measurement accuracy ... Ventilation unit module M4.1 (pressure-/flow temperature monitoring) ... 4.8.1 Calibration of pressure sensors... 4.8.2 Offset of the inspiratory pressure sensor ...
25 25 25 26 26 27 28 28 29 29 29 29 29 30 30 30 31 31 31 31 32 32 32 32 33 33 33 33 33 33 34 34 34 34 35 36 36 36 37 37 38 38 38 39 39 39
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4.8.3 Offset of the expiratory pressure sensor... 39 4.8.4 Temperature measurement of module M4.1... 40 4.8.5 Calibration of expiratory flow sensor ... 40 4.8.6 Reference voltage of module M4.1... 40 4.9 Safety devices... 40 4.9.1 Emergency expiratory valve SV2 ... 41 4.9.2 Emergency respiratory valve SV3 ... 41 4.9.3 Non-return valve in expiratory valve ... 42 4.9.4 Expiratory resistance of adult expiratory valve ... 43 4.10 Ventilation unit power supply module M7.3 Plus... 44 4.10.1 Fan ... 44 4.10.2 Supply voltage ... 44 4.10.3 Internal temperature ... 44 4.11 Emergency backup battery of the ventilation unit, part 1 ... 44 4.12 Ventilation unit PI self-tests... 45 4.12.1 Self-tests of the ventilation unit... 45 4.12.2 Flush flow M12.4 ... 46 4.12.3 "IST Airway Pressure Measurement"... 46 4.12.4 "Pneumatic Release Logic Test"... 46 4.12.5 Pressure sensors S2 and S8 ... 46 4.12.6 Expiratory flow measurement ... 47 4.13 Emergency backup battery of the ventilation unit, part 2 ... 47 4.13.1 Battery parameters ... 47 4.14 Ventilation unit, interior temperature ... 48 4.14.1 Testing ... 48 4.15 Ventilation unit, Piezo... 48 4.15.1 Function check ... 48 4.16 Nurse call ... 49 4.16.1 Nurse call with nurse call box (8417370)... 49 4.17 Ventilation unit, expiratory valve heating... 49 4.17.1 Function check ... 49 4.18 (Option) Ventilation unit, nebulizer ... 50 4.18.1 Function check ... 50 4.19 (Option) medication nebulizer (white housing)... 50 4.20 (Option) MCable Mainstream CO2 module M11.1 (CO2 sensor) ... 51 4.20.1 Function check ... 51 4.21 (Option) Neonatal expiratory valve ... 51 4.21.1 Function check ... 51 4.22 (Option) Neonatal flow sensor ... 52 4.22.1 Function check ... 52 4.23 (Option) GS500... 52 4.23.1 Function check ... 52 4.24 Medical device, function tests in operation mode ... 53 4.24.1 Self-test ... 53 4.24.2 System test ... 53 4.24.3 Breathing circuit test ... 54 4 / 62
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Evita V800 / V600 Table of contents
54 55 55 56 56 56 57 58 58 58 59 60
No.2201_0000011578
4.24.4 Function tests in ventilation mode ... 4.24.5 Non-return valves in the gas inlet... 4.24.6 Display of the ventilation unit... 4.24.7 Alarm silence key ... 4.25 (Option) PS500 ... 4.25.1 Function check ... 4.26 Final procedures ... 4.26.1 Device status report ... 4.26.2 Device handover with test label... 5 Test equipment 5.1 Test equipment subject to mandatory calibration... 5.2 Test equipment not subject to mandatory calibration...
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Basic safety information
Basic safety information Complying with the documentation Without exact knowledge of and compliance with this documentation, carrying out the measures described herein could lead to personal injury, damage to property, or damage to the environment. Using the product without exact knowledge of and compliance with the corresponding instructions for use could lead to personal injury, damage to property, or damage to the environment. ► Make sure that you have the current revision of this documentation. Use only the current revision of this documentation. ► Carefully read and comply with the measures described in this documentation. ► Carefully read and comply with the instructions for use.
Oxygen fire If pressurized connections are operated with oxygen, contact with oil or grease may lead to an oxygen fire. An oxygen fire can lead to personal injury and damage to the device. ► Pipes and connections carrying oxygen must be kept free of grease and oil, inside and out. ► Wear suitable gloves.
Service If the service activities are not performed or not performed correctly, it may result in personal injury, property damage, or environmental damage. ► Observe the servicing information contained in the instructions for use. ► Service activities must be performed correctly and by the user group which is designated for the respective activity. ► Only perform service activities and only connect the service PC if no patient is connected to the product.
Test instructions These test instructions contain all the tests required for testing after a repair. The use of different test instructions may lead to personal injury, property damage, and environmental damage.
No.2201_0000011578
► Use these test instructions for testing after a repair.
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General information
General information All results and inputs must be recorded in the electronic test instructions or in a printed outcome document.
1
Device configuration This chapter contains test steps to document the configuration. Introduction
The test scope includes the following components: – Control unit – Ventilation unit with expiratory valves – All hardware options
1.1
Serial numbers
43486
Test set-up
Fig. 1
Rating plate, control unit
• Read off the serial number from the rating plate (Fig. 1/1) of the control unit.
Result
Serial number of the control unit
[________txt]
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Action
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Device configuration
41326
Test set-up
Fig. 2
Rating plate, ventilation unit
Action
• Read off the serial number from the rating plate (Fig. 2/1) of the ventilation unit.
Result
Serial number of the ventilation unit
Action
• Read off the serial number from the side of the inspiratory valve.
Result
Serial number of the inspiratory valve
Action
• Document the expiratory valve used.
Result
Document the use of a disposable expiratory valve (YES/NO) with "Yes" or "No".
[________txt]
[________txt]
[________txt]
Disposable expiratory valves have no serial number.
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Action
• Read off the serial number of the (reusable) adult expiratory valve from the side of the expiratory valve.
Result
Serial number of the (reusable) adult expiratory valve
Action
• Read off the serial number of the second (reusable) adult expiratory valve if present.
Result
Serial number of the second adult expiratory valve (reusable)
Action
• If present, read off the serial number of the optional MCable Mainstream CO2 (CO2 sensor) from the sensor housing.
Result
Serial number of the optional MCable Mainstream CO2 (CO2 sensor)
Action
• Read off the serial number on the neonatal expiratory valve, if present.
Result
Serial number of the neonatal expiratory valve
Action
• Read off the serial number on the second neonatal expiratory valve, if present.
Result
Serial number of the second neonatal expiratory valve
Test instructions / Service Card IPM-L
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[________txt]
[________txt]
[________txt]
[________txt]
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No.2201_0000011578
[________txt]
Evita V800 / V600
Maintenance parts
1.2
Action
• Read off the serial number of the GS500, if present. Note: The serial number is located on the rating plate above the power supply socket (remove the left side cover).
Result
Serial number of the GS500
Action
• Read off the serial number of the PS500, if present. Note: The serial number is located on the rating plate on the rear of the PS500.
Result
Serial number of the PS500
Action
• Read off the part number of the PS500, if present. Note: The part number is located on the rating plate on the rear of the PS500.
Result
Part number of the PS500
Action
• Read off the serial number of the trolley, if present. Note: The serial number is located on the rating plate on the rear of the trolley.
Result
Serial number of the trolley
Action
• Read off whether the optional nebulizer ejector (no serial number) is present from the inner side of the housing flap and enter "Yes" (if present) or "No" (if not present) in the text field.
Result
Nebulizer ejector (no serial number) (YES/NO)
Action
• Read off whether the optional neonatal flow measurement (no serial number) is present from the inner side of the housing flap and enter "Yes" (present) or "No" (not present) in the text field.
Result
Neonatal flow measurement (no serial number) (YES/NO)
[________txt]
[________txt]
[________txt]
[________txt]
[________txt]
[________txt]
Software version The software version is read out in the following section: Functional and condition test > Rating and readout of software version and operating data > Software version
2
Maintenance parts This chapter contains information on maintenance parts, measures and tests.
2.1
Maintenance intervals, overview
2.1.1
Maintenance intervals and required sets and parts
No.2201_0000011578
The following table presents an overview of the required sets and maintenance parts over 6 years. After 6 years the table is worked through again starting with the first year. Designation Ventilation unit, battery M7 NM2.5 |
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Part number 8415290
1
2 x
3
4 x
5
6 x 9 / 62
Evita V800 / V600
Maintenance parts
Designation Part number Ventilation unit, particle filter (O2 filter) 8415127 Ventilation unit, Air filter (medical com8421479 pressed air filter) (Option) GS500, room air filter (filter mat) 8419758 (Option) GS500, air filter blower unit (micro- 6737545 filter) (Option) PS500, battery set PS500 (Service) 8422969 15Ah
1
2
3
x
x
2.2.1
Ventilation unit, internal battery M7
6 x x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
– VRLA batteries Only for devices with (optional) medication nebulizer: Ventilation unit, pressure regulator (O2 side) 8417029
Maintenance parts by specified interval
5
x
– LFP batteries (Option) PS500, battery set PS500 (Service) 8420500 24Ah
2.2
4
x
Observe the battery's safety data sheet. Batteries are hazardous waste. Dispose of the batteries in accordance with local waste disposal regulations. After replacing the battery, the following steps must be performed: – In the Advanced > Battery service dialog, reset the batteries’ operating data. – Enter the new battery’s part number (with revision index) and serial number. – Set the time on the device again. The battery must be fully charged after replacement. The charging process does not need to be monitored. The battery is fully charged when no bar is flashing near the battery symbol on the screen. Quantity 1
Result
Designation
Number
Location/Remark
Battery M7 NM2.5
8415290
Refer to the repair instructions, the data sheet and the safety data sheet of the battery
Battery M7 NM2.5
No.2201_0000011578
Next replacement: [________dat]
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Maintenance parts
2.2.2
Ventilation unit, particle filter (O2 filter) Quantity 1 Result
Designation
Number
Location/Remark
Particle filter (O2 filter)
8415127
In O2 gas inlet/Replacement by specialist.
Particle filter (O2 filter) Next replacement: [________dat]
2.2.3
Ventilation unit, Air filter (medical compressed air filter) Quantity 1 Result
Designation
Number
Location/Remark
Air filter
8421479
In Air gas inlet/Replacement by specialist.
Air filter Next replacement: [________dat]
2.2.4
(Option) GS500, room air filter (filter mat) Quantity 1 Result
Designation
Number
Location/Remark
Room air filter (filter mat)
8419758
Refer to the maintenance instructions
Room air filter (filter mat) Next replacement: [________dat]
2.2.5
(Option) GS500, air filter blower unit (microfilter) Quantity 1 Result
Designation
Number
Location/Remark
Air filter blower unit (microfilter)
6737545
Refer to the maintenance instructions
Air filter blower unit (microfilter) Next replacement: [________dat]
2.2.6
(Option) PS500, battery set PS500 (Service) 15Ah
No.2201_0000011578
The battery must be fully charged after replacement. The charging process does not need to be monitored. The battery is fully charged when no bar is flashing near the battery symbol on the screen.
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Maintenance parts
Quantity 1
Designation
Number
Location/Remark
Battery set PS500 (Service) 15Ah
8422969
Refer to the repair instructions, the safety data sheet and the battery's data sheet
– LFP batteries Result
Battery set PS500 (Service) 15Ah Next replacement: [________dat]
2.2.7
(Option) PS500, battery set PS500 (Service) 24Ah The battery must be fully charged after replacement. The charging process does not need to be monitored. The battery is fully charged when no bar is flashing near the battery symbol on the screen. Quantity 1
Designation
Number
Location/Remark
Battery set PS500 (Service) 24Ah
8420500
Refer to the repair instructions, the safety data sheet and the battery's data sheet
– VRLA batteries Result
Battery set PS500 (Service) 24Ah Next replacement: [________dat]
2.2.8
(Option) Medication nebulizer, pressure regulator (O2-side) Quantity 1 Result
Designation
Number
Location/Remark
Pressure regulator (O2- 8417029 side)
Medication nebulizer / replacement by specialist
Pressure regulator (O2-side) Next replacement: [________dat]
Maintenance parts as required Designation Ventilation unit Expiratory valve diaphragm
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Part number
Location/Remark
8413661
Diaphragm in the expiratory valve Check the condition. Replacement by user Filter in the housing fan Check the condition. Replacement by user
Room air filter
8416753
Expiratory valve Lip seal (gray)
8416201
Expiratory valve Replacement by maintenance personnel
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2.3
Evita V800 / V600
Electrical safety
Designation Part number Location/Remark Flow sensor 8416203 Expiratory valve sleeve, complete Replacement by maintenance personnel (gray) Neonatal expiratory valve (if present) Lip seal 8415261 Neonatal expiratory valve Replacement by maintenance personnel
3
Electrical safety This chapter contains tests on the electrical safety. Perform the tests according to IEC 62353 or IEC 60601-1 (depending on the national guidelines. In Germany, for example, standard DIN EN 62353 applies).
3.1
Electrical safety according to IEC 62353 The medical device under test conforms to the conditions of protection class I. With the MCable-Mainstream CO2 module M11.1 (CO2 sensor) (sensor connected) or the neonatal flow sensor the medical device conforms to type BF. The tester, e.g. SECUTEST, must be correctly configured for all measurements. If implausible measurement results are obtained, such as a leakage current of 0.0 µA, check the tester configuration in addition to the test setup! In testing to IEC 62353, the medical electrical device (ME device) or the medical electrical system (ME system) must be tested. ME systems must be treated like ME devices. An ME system is a combination of several devices, as specified by the manufacturer, of which at least one must be an ME device, which are interconnected by a functional connection or by means of a multiple socket outlet. With devices that are connected to other devices by means of a data cable, this connection must be disconnected prior to performing the electrical safety check, in order to avoid incorrect measurements.
3.1.1
Visual inspection Prerequisites
The testing device and the device under test are switched off.
WARNING
No.2201_0000011578
Risk of electric shock Touching live components can lead to serious injury or death. ► Disconnect the device from the power supply. Action
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• Unplug the mains power plug from the socket outlet.
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Electrical safety
Test
– The power fuse links of the device under test match the specifications on the housing. – The power cable and power plug are not dirty or damaged.
Result
3.1.2
Condition checked
[________OK]
Protective earth resistance
1936
Test set-up
Fig. 3
Protective earth resistance
Item Designation 1 2 3 L N PE Action
Testing device Device under test Probe cable for the testing device Conductor Neutral conductor Protective conductor
• Establish the test setup. • Switch on the testing device. • Configure the testing device appropriately and follow its instructions. • Using the tip of the probe cable, scan each of the measuring points on the device under test listed under "Protective earth resistance measuring points" one after the other, moving the mains power supply cord along the entire length during the measurement. The resistance must not change when you do so.
Test
Result
The protective earth resistance of single devices (including the permanently installed power supply cord, or power supply cord detachable only by use of tools) must not exceed 0.3 Ohm in each case. Maximum measured value of the ME device
[________Ω]
or Test
Maximum measured value of ME system.
[________Ω] No.2201_0000011578
Result
The protective earth resistance of ME systems (including mains power cable) must not exceed 0.5 ohms in each case.
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Electrical safety
3.1.3
Protective earth resistance measuring points Action
• Scan the following measuring points for the protective earth resistance measurement one after the other using the tip of the probe cable: – Potential equalization pin on the power supply unit of the ventilation unit
Result
3.1.4
Measuring points scanned.
[________OK]
Test adapters for equipment leakage current Prerequisites
The following device-specific test adapter is only necessary for the optional Neo-Flow: – 7901772, VDE Babylog test plug (only with the optional Neo-Flow)
3.1.5
Device leakage current The equipment leakage current can be tested by the differential measurement method or the direct measurement method. In direct measurement, set up the device under test with insulation and scan all accessible conductive components using the probe (the protective earth is internally interrupted in the tester). Prerequisites
The tester is switched on.
1932
Test set-up
Fig. 4
Equipment leakage current
Item Designation 1 2 3 4 L N PE Action
Tester Device under test (Applied part) Device-specific test adapter for tester (Applied part) Configurable ports for applied part Conductor Neutral conductor Protective earth
• Prepare the test setup.
No.2201_0000011578
• (Applied part) Connect the device-specific test adapter on one end to the device under test and on the other end to the tester's configurable port "A" for applied parts (paying attention to the configuration!). • Follow the instructions on the tester.
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Electrical safety
Perform the test twice. In the second test attach the connector in the socket rotated 180°. In many test devices the mains plug rotation is simulated by means of a built-in selector switch. Document the higher measured value. Always enter the reference value (initial value measured) in the "Test Report" or "Result Sheet" document. If the measured values are between 90% and 100% of the permissible limit value, apply the reference value and the previously measured values of the recurrent test to assess electrical safety! Test Result Test Result
3.1.6
The reference value must not exceed 500 µA. Reference value
[________µA]
The recurrent test value must not exceed 500 µA. Recurrent test
[________µA]
Applied parts for leakage current from applied part test Only perform the patient leakage current test if the optional Neo-Flow measurement is present. With the optional MCable Mainstream CO2 sensor, no measurement of the leakage current of the applied part is performed due to the galvanic isolation being made in the sensor head and the sensor having no metallic contacts. As a substitute, a visual inspection is performed in the Condition test chapter. Prerequisites
The following device-specific test adapter is only necessary for the optional Neo-Flow: – 7901772, VDE Babylog test plug (only with the optional Neo-Flow)
3.1.7
Applied part leakage current, mains on applied part, type BF Prerequisites
The tester is switched on.
2267
Test set-up
Fig. 5
Leakage current on applied part
1 2 3 4
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Tester Device under test Applied part, device-specific test adapters for tester Configurable connection sockets for applied parts (A - K)
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Item Designation
Evita V800 / V600
Electrical safety
Item L N PE Action
Designation Conductor Neutral conductor Protective earth
• Prepare the test setup. • (Applied part) Connect the device-specific test adapter on one end to the device under test and on the other end to the tester's configurable port "A" for applied parts (paying attention to the configuration!). • Follow the instructions on the tester. The test must be performed twice! The second test is performed with the plug rotated 180° in the socket. In many test devices the mains plug rotation is simulated by means of a built-in selector switch. The higher measured value must be documented. The reference value (initial measured value) must always be transmitted! If the measured values are between 90% and 100% of the permissible limit value, the reference value and the previously measured values of the recurrent test should be applied to assess electrical safety!
Test Result Test Result
3.2
The reference value must not exceed 5000 µA. Reference value
[________µA]
The recurrent test value must not exceed 5000 µA. Recurrent test
[________µA]
Electrical safety according to IEC 60601-1 The medical device under test conforms to the conditions of protection class I. With the MCable-Mainstream CO2 module M11.1 (CO2 sensor) (sensor connected) or the neonatal flow sensor the medical device conforms to type BF. An optional multiple socket-outlet, if any, must be included in the individual tests (medical electrical system). With devices that are connected to other devices by means of a data cable, this connection must be disconnected prior to performing the electrical safety check, in order to avoid incorrect measurements.
3.2.1
Visual inspection Prerequisites
The following preconditions must be met for the visual inspection: – The medical device is switched off. – The mains plug has been removed.
No.2201_0000011578
– The central supply hoses have been removed.
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Electrical safety
Test
– The nominal values of the power fuse links of the ventilation unit match the specifications on the imprint of the housing. – The power cable and the strain relief of the ventilation unit are not dirty or damaged.
Result
3.2.2
Condition checked.
[________OK]
Protective earth resistance
769
Test set-up
Fig. 6
Test setup for protective earth resistance
Item Designation 1 2 3 L N PE Action
Testing device, e.g. SECUTEST, 7910594 Device under test Probe with testing tip (e.g. SECUTEST accessory) Conductor Neutral conductor Protective conductor (Protective Earth)
• Establish the test setup. • Switch the testing device on. • Configure the testing device appropriately and follow its instructions. • Scan the following points on the ventilation unit one after the other with the probe's testing tip, moving the power cord section by section: – Potential equalization pin on the power supply unit
Test
The protective earth resistance value must not exceed 0.2 Ohms (including the power cable) in each case.
Result
Protective earth resistance, ventilation unit
Action
• Establish the test setup.
[________Ω]
• Switch on the testing device. • Configure the testing device appropriately and follow its instructions.
• Fixation claw of the GS500 on the trolley Test Result 18 / 62
The protective earth resistance value must not exceed 0.2 Ohms (including the power cable) in each case. Optional protective earth resistance GS500 Test instructions / Service Card IPM-L
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• Scan the following points on the GS500 one after the other with the probe's testing tip, moving the power cord section by section:
Evita V800 / V600
Electrical safety
3.2.3
Earth leakage current medical device To avoid incorrect measurements, place the ventilation unit in an isolated place.
218
Test set-up
Fig. 7
Earth leakage current test setup
Item Designation 1 2 L N PE Action
Testing device, e.g. SECUTEST, 7910594 Device under test Conductor Neutral conductor Protective conductor (Protective earth)
• Establish the test setup. • Switch on the medical device. • Follow the instructions on the testing device. For symmetrical mains plugs that have no preferential position in the power socket, perform the earth leakage current test twice! The second test is performed with the plug rotated 180° in the socket. In many test devices the power plug rotation is simulated by means of a built-in selector switch. The higher measured value must be documented.
Test Result Test Result
3.2.4
Normal condition (N.C.) IEC 60601-1: The value must not exceed 200 µA. Normal condition (N.C.) IEC 60601-1
[________µA]
Single fault condition (S.F.C.): The value must not exceed 400 µA. Single fault condition (S.F.C.) IEC 60601-1
[________µA]
Patient leakage current
No.2201_0000011578
Only perform the patient leakage current test if the optional Neo-Flow measurement is present. With the optional MCable Mainstream CO2 sensor, no measurement of the patient leakage current part is performed due to the galvanic isolation being made in the sensor head and the sensor having no metallic contacts. As a substitute, a visual inspection is performed in the Condition test chapter.
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Electrical safety
425
Test set-up
Fig. 8
Patient leakage current test setup
Item Designation 1 2 3 4 L N PE Action
Testing device, e.g. SECUTEST(7910594) Device under test Test plug (7901772) Ports for applied parts Conductor Neutral conductor Protective conductor (Protective Earth)
• Establish the test setup. • Connect the Neo-Flow sensor cable to the ventilation unit. • Remove the Neo-Flow sensor. • Insert the test plug (7901772) in the Neo-Flow sensor socket and connect it to the testing device. • Put the device under test into operation and perform the patient leak current measurements. • Follow the instructions on the testing device. For symmetrical power plugs that have no preferential position in the power socket, perform the patient leakage current test twice. The second test is performed with the plug rotated 180° in the socket. In many test devices the power plug rotation is simulated by means of a built-in selector switch. Document the higher measured value.
Result Test Result Test Result Test Result
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Normal condition (N.C.) DC IEC 60601-1: The value must not exceed 10 µA. Normal condition (N.C.) DC IEC 60601-1
[________µA]
Normal condition (N.C.) AC: The value must not exceed 100 µA. Normal condition (N.C.) AC IEC 60601-1
[________µA]
Single fault condition (S.F.C.) DC: The first value measured must not exceed 50 µA. Single fault condition (S.F.C.) DC IEC 60601-1
[________µA]
Single fault condition (S.F.C.) AC: The value must not exceed 500 µA. Single fault condition (S.F.C.) AC IEC 60601-1
Test instructions / Service Card IPM-L
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[________µA]
Revision 4.0
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No.2201_0000011578
Test