Babylog VN500 Test Instructions / Service Card IPM-L Rev 20.0

Workstation Neonatal Care Table of contents

1 1.1

2 2.1 2.2

2.3 3 3.1

3.2

4 4.1

4.2

4.3

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Important notes 6 Device configuration 6 Device configuration ... 6 1.1.1 Serial numbers (if not otherwise recorded)... 6 1.1.2 Software versions ... 7 Maintenance parts 7 Maintenance intervals, overview... 8 2.1.1 Maintenance intervals and required sets and parts ... 8 Maintenance parts by specified interval... 8 2.2.1 V-unit, battery M7 NM2,5 ... 8 2.2.2 V-unit, particle filter (O2 filter) ... 9 2.2.3 V-unit, air filter... 9 2.2.4 (Option) GS500, room air filter (filter mat) ... 10 2.2.5 (Option) GS500, air filter blower unit (microfilter) ... 10 2.2.6 (Option) PS500, battery set PS500 (Service) 15Ah ... 10 2.2.7 (Option) PS500, battery set PS500 (Service) 24Ah ... 10 2.2.8 (Option) Medication nebulizer, pressure regulator (O2-side)... 11 Maintenance parts as required ... 11 Electrical safety 11 Electrical safety of V-unit or ME system according to DIN EN 62353 (IEC 62353) ... 12 3.1.1 Visual inspection... 12 3.1.2 Protective earth resistance ... 13 3.1.3 Protective earth resistance measuring points... 13 3.1.4 Applied parts for device leakage current ... 14 3.1.5 Device leakage current ... 14 3.1.6 Applied parts for leakage current from applied part test ... 15 3.1.7 Applied part leakage current, mains on applied part, type BF ... 15 Electrical safety according to IEC 60601-1 ... 16 3.2.1 Visual inspection... 16 3.2.2 Protective earth resistance ... 17 3.2.3 Earth leakage current medical device ... 17 3.2.4 Patient leakage current... 19 Function and condition test 20 General condition check ... 20 4.1.1 Medical device ... 20 4.1.2 Accompanying documents ... 20 4.1.3 Rating plates, labels and notices on the medical device ... 20 4.1.4 Rating plates, labels and notices on the installed options ... 23 C500 and V-unit condition test ... 24 4.2.1 C500 ... 24 4.2.2 V-unit ... 25 Condition test, options ... 25 4.3.1 (Option) MCable Mainstream CO2 module M11.1 (CO2 sensor) ... 25 4.3.2 (Option) Medication nebulizer... 25 Test instructions / Service Card IPM-L

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Table of contents

Workstation Neonatal Care Table of contents

4.4

4.5 4.6

4.7

No.1612_0000007473

4.8

4.9

4.3.3 (Option) Trolley... 4.3.4 (Option) Gas cylinder holder ... 4.3.5 (Option) Hose holder ... 4.3.6 (Option) GS500 ... 4.3.7 (Option) PS500... 4.3.8 (Option) Cable duct ... Fuse rating and readout of software version and operating data ... 4.4.1 Fuse value... 4.4.2 Software version of medical device... 4.4.3 Battery operating data of the medical device with M7.3... 4.4.4 Battery operating data of the medical device with M7.3 Plus... Preparations for the function tests ... 4.5.1 Preparations ... C500, function tests ... 4.6.1 Pixel test... 4.6.2 Acoustic alarm... 4.6.3 "Red" and "yellow" visual alarms... 4.6.4 Rotary encoder lighting ... V-unit, function test of module M1.3 (gas dosage module)... 4.7.1 V-unit self-tests... 4.7.2 AIR proportional valve step response time... 4.7.3 O2 proportional valve step response time... 4.7.4 Zeroing all flow sensors... 4.7.5 Relative flow difference S2/S3 ... 4.7.6 Relative flow difference S1/S3 ... 4.7.7 Leakage LPSV V3 ... 4.7.8 Valve calibration for workstations with gas supply unit GS500 ... 4.7.9 Comparator shut-off pressure ... 4.7.10 Comparator switch-on pressure ... 4.7.11 Proportional valve AIR 120 L/min ... 4.7.12 Proportional valve AIR 5 L/min ... 4.7.13 Proportional valve O2 120 L/min ... 4.7.14 Proportional valve O2 5 L/min ... 4.7.15 "System Leakage Test (M1V3)"... 4.7.16 Leakage, AIR proportional valve ... 4.7.17 Leakage, O2 pipeline supply non-return valve ... 4.7.18 Leakage, O2 proportional valve ... 4.7.19 Leakage, AIR pipeline supply non-return valve ... 4.7.20 Comparative pressure measurement, Ptank and inspiratory pressure sensor ... 4.7.21 Comparative flow measurement M1.3... V-unit, function test of module M12.4 (Pato standalone) ... 4.8.1 Calibration ... 4.8.2 Measurement accuracy ... V-unit, function test of module M4.1 (pressure/flow temperature monitoring) ... 4.9.1 Calibration of pressure sensors... 4.9.2 Offset of the inspiratory pressure sensor ...

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4.9.3 Offset of the expiratory pressure sensor... 42 4.9.4 Temperature measurement of module M4.1... 42 4.9.5 Reference voltage of module M4.1... 42 4.10 V-unit, function test of module M21 East ... 42 4.10.1 Function test ... 43 4.11 V-unit, function test of safety devices... 43 4.11.1 Emergency expiratory valve SV2 ... 43 4.11.2 Emergency respiratory valve SV3 ... 44 4.11.3 Non-return valve in expiratory valve ... 45 4.11.4 Expiratory resistance of neonatal expiratory valve ... 46 4.11.5 Neonatal flow sensor ... 47 4.12 V-unit, function test of the power supply unit module M7.3 / M7.3 Plus... 47 4.12.1 Fan ... 48 4.12.2 Supply voltage ... 48 4.12.3 Internal temperature ... 48 4.13 V-unit, function test of internal power failure backup battery, part 1 ... 48 4.13.1 Powerfail mode function test ... 49 4.14 V-unit, "PI self-tests" function tests ... 49 4.14.1 V-unit self-tests ... 49 4.14.2 Flush flow M12.4 ... 50 4.14.3 IST neonatal flow sensor ... 50 4.14.4 "IST Airway Pressure Measurement"... 50 4.14.5 "Pneumatic Release Logic Test"... 51 4.14.6 Pressure sensors S2 and S8 ... 51 4.15 V-unit, function test of internal power failure backup battery, part 2 ... 51 4.15.1 Battery parameters ... 52 4.16 V-unit, test of device internal temperature ... 53 4.16.1 Testing ... 53 4.17 V-unit, function test of piezo... 53 4.17.1 Function test ... 53 4.18 V-unit, function test of nurse call ... 53 4.18.1 Nurse call with nurse call box (8417370)... 54 4.18.2 Nurse call with test adapter (7911671) ... 54 4.19 V-unit, function test of expiratory valve heater ... 55 4.19.1 Function test ... 55 4.20 Option, V-unit, function test of nebulizer ejector ... 55 4.20.1 Function test ... 55 4.21 Option, V-unit, function test of drug nebulizer ... 56 4.21.1 Function test ... 56 4.22 Option, V-unit, function test of Mcable-Mainstream CO2 module M11.1 (CO2 sensor)... 56 4.22.1 Function test ... 57 4.23 Option, V-unit, Function test of GS500 ... 57 4.23.1 Function test ... 57 4.24 Medical device, function tests in operation mode ... 58 4.24.1 Self-test ... 58 4.24.2 Device checks ... 59 4 / 68

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4.24.3 Expiratory valves leak test... 4.24.4 Function tests in ventilation mode ... 4.24.5 V-unit display function test... 4.24.6 Function test of acoustic alarm, only for SW2.40 and SW2.41 ... 4.24.7 Function test of Silence key ... 4.25 Option, PS500 function test ... 4.25.1 Function test... 4.26 Medical device, final action... 4.26.1 Calibration of the touchscreen... 4.26.2 Device status report ... 4.26.3 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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Workstation Neonatal Care

Important notes

Important notes Configuration of Workstation Neonatal Care (medical device): - Infinity C500 operating and display unit (C500) - Babylog VN500 ventilation unit (V-unit) with expiratory valves Options: - Nebulizer-ejector - Mcable-Mainstream CO2 module M11.1 (CO2 sensor) - Medication nebulizer - Gas supply unit (GS500) - Power supply unit (PS500) - Trolley 2

NOTE Prior to using these test instructions, check that they are the latest revision (compare revision with latest service documentation). All results and inputs must be documented in the "Test Report" and "Result Sheet". These test instructions apply to software version 2.0 and higher. Conversion table: 1 bar = 14.504 PSI / 1 mbar = 1.01973 cm H2O.

1

Device configuration This chapter contains test steps to document the configuration.

1.1

Device configuration Introduction

The testing covers the following components: – C500 – V-unit with expiratory valves – All options as per cover sheet

Serial numbers (if not otherwise recorded) Prerequisites

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The medical device is switched off.

Action

• Read off serial number of C500. Note: The serial number is located on the rear of the C500.

Result

C500 serial number

Action

• Read off V-unit serial number. Note:The serial number is located above the power supply unit filter.

Result

Serial number of V-unit

Test instructions / Service Card IPM-L

[________txt]

[________txt]

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1.1.1

Workstation Neonatal Care

Maintenance parts

1.1.2

Action

• Remove the inspiratory safety valve (inspiration unit) from the V-unit and read of its serial number. Note: The serial number is located on the side of the inspiratory safety valve.

Result

Serial number of inspiratory safety valve (inspiration unit)

Action

• Remove the neonatal expiratory valve from the V-unit and read off its serial number. Note: The serial number is located on the side of the expiratory valve.

Result

Serial number of neonatal expiratory valve

Action

• Read off the serial number of the additional neonatal expiratory valve, if fitted.

Result

Serial number of additional neonatal expiratory valve

Action

• Read off the serial number of the MCable-Mainstream CO2 option (CO2 sensor), if fitted. Note: The serial number is located on the sensor housing.

Result

Serial number of MCable-Mainstream CO2 (CO2 sensor) option

Action

• Read off the serial number of the GS500 option, if fitted. Note: The serial number is located on the rating plate, above the power supply socket (remove left side cover).

Result

Serial number of GS500 option

Action

• Read off the serial number of the PS500 option, if fitted. Note: The serial number is indicated on the rating plate on the rear of the PS500.

Result

Serial number of PS500 option

Action

• Read off the serial number of the trolley option, if installed. Note: The serial number is indicated on the rating plate on the rear of the trolley.

Result

Serial number of trolley option

Action

• On the inside of the housing flap, read whether the nebulizer/ejector additional hardware option (without serial number) is fitted and enter "Yes" (fitted) or "No" (not fitted) in the text box.

Result

Nebulizer ejector additional hardware option (without serial number) (Yes or No)

[________txt]

[________txt]

[________txt]

[________txt]

[________txt]

[________txt]

[________txt]

[________txt]

Software versions

NOTE The software versions are read under "Readout of software version and operating data".

2

Maintenance parts

No.1612_0000007473

This chapter contains information on maintenance parts, measures and tests.

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Workstation Neonatal Care

Maintenance parts

2.1

Maintenance intervals, overview

2.1.1

Maintenance intervals and required sets and parts 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

Part number Comments V-unit, battery M7 NM2.5 8415290 8415127 V-unit, particle filter (O2 filter) V-unit, air filter (Air filter) 8421479 (Option) GS500, room air filter (filter 8419758 mat) (Option) GS500, blower unit air filter 6737545 (microfilter) (Option) PS500, battery set PS500 8422969 (Service) 15 Ah (1) – LFP batteries (Option) PS500, battery set PS500 8420500 (Service) 24 Ah

1

2

3

4

x

x

x

x

5

6 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: V-unit, pressure regulator (O2-side) 8417029

x

x

x

(1) Valid for devices with the battery characteristic 03062. The replacement interval for characteristic 03060 is 2 years.

2.2

Maintenance parts by specified interval

2.2.1

V-unit, battery M7 NM2,5

NOTE After replacing the batteries, the battery wear data must be reset in the "Operating Data" service menu. In addition, for a new battery the material number with revision index and the serial number of the new battery must be entered.

NOTE

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Batteries are special waste. Dispose of batteries in accordance with local waste disposal regulations.

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Maintenance parts

NOTE – In connection with a M7.3 power supply unit (8415328): If the PS500 option is present, there is no internal battery. – In connection with a M7.3 Plus power supply unit (8421200): The internal battery is always installed. The PS500 option may also be present. An installed M7.3 Plus power supply unit can be identified on the additional connection box behind the left side door.

NOTE After replacing the battery it must be fully charged once. The battery is fully charged when none of the bars in the on-screen battery icon is flashing any more. 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 Next replacement: [________dat]

2.2.2

V-unit, particle filter (O2 filter) Quantity 1 Result

Designation

Number

Location/Remark

Particle filter (O2 filter)

8415127

In the O2 gas inlet/replacement by experts.

Particle filter (O2 filter) Next replacement: [________dat]

2.2.3

V-unit, air filter Quantity 1 Result

Designation

Number

Air filter (medical 8421479 compressed air filter)

Location/Remark In the Air gas inlet/replacement by experts.

Air filter (medical compressed air filter)

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Next replacement: [________dat]

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Maintenance parts

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 Depending on the battery characteristic, the battery set has to be replaced as follows: Battery characteristic 03060 03062

Replacement interval 2 years 4 years

NOTE 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) 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

After replacing the battery it must be fully charged once. The battery is fully charged when none of the bars in the on-screen battery icon is flashing any more.

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NOTE

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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

Pressure regulator (O2- 8417029 side)

Location/Remark Medication nebulizer / replacement by specialist

Pressure regulator (O2-side) Next replacement: [________dat]

2.3

Maintenance parts as required Designation V-unit Expiratory valve diaphragm

Part number

Location/Remark

8413661

Room air filter

8416753

Diaphragm in the expiratory valve Check condition Replacement by user Filter in the housing fan Check condition Replacement by user

Expiratory valve Lip seal (gray)

8416201

Neonatal expiratory valve Lip seal 8415261

3

Expiratory valve Replacement by maintenance personnel Neonatal expiratory valve Replacement by maintenance personnel

Electrical safety This chapter contains tests on the electrical safety.

No.1612_0000007473

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).

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Workstation Neonatal Care

Electrical safety

3.1

Electrical safety of V-unit or ME system according to DIN EN 62353 (IEC 62353) NOTE 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.

NOTE 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!

NOTE 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.

NOTE In the case of devices connected to other devices by a data cable, this connection must be disconnected prior to performing the electrical safety test, in order to avoid false measurements.

3.1.1

Visual inspection Prerequisites

The tester and the device under test are switched off.

WARNING Hazardous voltage. Touching live components can lead to serious injury or death. ► Disconnect the power cord from the AC outlet before checking the power fuse-links. Action Test

• Disconnect the power plug from the mains socket. – The power fuse-links of the device under test match the specifications on the rating plate. – The power cable and plug are not dirty or damaged. Condition checked.

[________OK] No.1612_0000007473

Result

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Electrical safety

3.1.2

Protective earth resistance

1936

Test set-up

Fig. 1

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 Result

3.1.3

The protective earth resistance of ME systems (including mains power cable) must not exceed 0.5 ohms in each case. Maximum measured value of ME system.

[________Ω]

Protective earth resistance measuring points Action

• Scan the following measuring points for protective earth resistance measurement one after the other using the tip of the probe cable:

No.1612_0000007473

– Potential equalization pin on the power supply unit of the V-unit Result

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Measuring points scanned.

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[________OK]

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Workstation Neonatal Care

Electrical safety

3.1.4

Applied parts for device leakage current

3.1.5

Action

• Use the following device-specific test adapters for the device under test:

Result

7901772, Babylog VDE test plug

[________OK]

Device leakage current

NOTE 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. 2

Device leakage current

Item Designation 1 2 3 4 L N PE Action

Tester Device under test (Applied part) Device-specific test adapters for tester (Applied part) Configurable ports for application components Conductor Neutral conductor Protective earth conductor

• Establish the test setup. • (Applied part) Connect one side of the test adapter to the device under test and the other side to the tester, configurable port "A" for applied parts (observe the configuration!). • Follow the instructions given by the tester.

The test must be performed twice on symmetrical mains plugs. In the second test the mains plug must be rotated through 180° before being plugged into 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.

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NOTE

Workstation Neonatal Care

Electrical safety

NOTE If the measured values are between 90 % and 100 % of the permissible limit value, use the previously measured values to assess the electrical safety. Test Result

3.1.6

The measured value must not be greater than 500 µA. Measured value

[________µA]

Applied parts for leakage current from applied part test

NOTE With the optional MCable Mainstream CO2 sensor, no measurement of the patient leakage current is performed due to the galvanic isolation in the sensor head and the sensor having no metallic contacts. As a substitute, a visual inspection is performed in the Condition test chapter.

3.1.7

Action

• Use the following device-specific test adapter for the device under test:

Result

7901772, VDE Babylog test plug

[________OK]

Applied part leakage current, mains on applied part, type BF Prerequisites

The tester is switched on.

2267

Test set-up

Fig. 3

Leakage current on applied part

Item Designation 1 2 3 4 L N PE Action

Tester Device under test Applied part, device-specific test adapters for tester Configurable ports for applied parts (A–K) Conductor Neutral conductor Protective earth conductor

• Establish the test setup.

No.1612_0000007473

• (Applied part) Connect one side of the test adapter to the device under test and the other side to the tester, configurable port "A" for applied parts (observe the configuration!). • Follow the instructions given by the tester.

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Workstation Neonatal Care

Electrical safety

NOTE The test must be performed twice on symmetrical mains plugs. In the second test the mains plug must be rotated through 180° before being plugged into 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.

NOTE If the measured values are between 90 % and 100 % of the permissible limit value, use the previously measured values to assess the electrical safety. Test Result

3.2

The measured value must not be greater than 5000 µA. Measured value

[________µA]

Electrical safety according to IEC 60601-1 NOTE 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.

NOTE An optional multiple socket-outlet, if any, must be included in the individual tests (medical electrical system).

NOTE In the case of devices connected to other devices by a data cable, this connection must be disconnected prior to performing the electrical safety test, in order to avoid false 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. – The CS hoses have been removed.

Test

– The nominal values of the power fuse links of the V-unit match the specifications on the imprint of the power supply unit. – The power cable and the strain relief of the V-unit are not dirty or damaged. – If fitted: The cable of the GS500 option is not dirty or damaged. Condition checked.

[________OK] No.1612_0000007473

Result

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3.2.2

Protective earth resistance

769

Test set-up

Fig. 4

Test setup for protective conductor resistance

Item Designation 1 2 3 L N PE Action

Tester, e.g. SECUTEST, 7910594 Device under test Test probe with tip (e.g. SECUTEST accessories) Conductor Neutral conductor (Protective Earth) conductor

• Prepare the test setup. • Switch the tester on. • Configure the tester appropriately, and follow the instructions on the tester. • Using the tip of the test probe, scan the following points on the V-unit, moving the power cable section-by-section while doing so: – Power supply unit potential equalization pin

Test Result

3.2.3

The protective earth resistance must not exceed 0.2 Ohm (including mains power cable) in each case. Protective conductor resistance of V-unit

[________Ω]

Earth leakage current medical device

NOTE

No.1612_0000007473

In order to avoid incorrect measurement, set up the V-unit so that it is insulated.

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218

Test set-up

Fig. 5

Earth leakage current test setup

Item Designation 1 2 L N PE Action

Tester, e.g. SECUTEST, 7910594 Device under test Conductor Neutral conductor (Protective earth) conductor

• Prepare the test setup. • Switch on medical device. • Follow the instructions on the tester.

NOTE For symmetrical mains plugs that have no preferential position in the socketoutlet, the earth leakage current 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. IEC 60-601-1 Test Result Test Result

Normal condition (N.C.): The value must not exceed 500 µA. Normal condition (N.C.) IEC 60-601-1

[________µA]

Single fault condition (S.F.C.): The value must not exceed 1000 µA. Single fault condition (S.F.C.) IEC 60-601-1

[________µA]

UL 60-601-1 Test Result Test

Normal condition (N.C.) UL 60-601-1

[________µA]

Single fault condition (S.F.C.): The value must not exceed 500 µA. Single fault condition (S.F.C.) UL 60-601-1

[________µA] No.1612_0000007473

Result

Normal condition (N.C.): The value must not exceed 300 µA.

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3.2.4

Patient leakage current

NOTE A patient leakage current measurement is only performed in neo-flow measurement. With the MCable-Mainstream CO2 sensor option no patient leakage current measurement is performed, as the electrical isolation is in the sensor head and the sensor has no metallic contacts. A visual check is performed alternately in the "Condition tests" section.

425

Test set-up

Fig. 6

Patient leakage current test setup

Item Designation 1 2 3 4 L N PE Action

Tester, e.g. SECUTEST, 7910594 Device under test Test plug, 7901772 Ports for applied parts Conductor Neutral conductor (Protective Earth) conductor

• Prepare the test setup. • Connect the Neo-Flow sensor cable to the V-unit. • Remove the Neo-Flow sensor. • Connect the test plug (7901772) to the Neo-Flow sensor socket and to the tester. • Start up the test specimen and perform patient leakage current measurements. • Follow the instructions on the tester.

NOTE

No.1612_0000007473

For symmetrical mains plugs that have no preferential position in the socketoutlet, the patient leakage current 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. IEC 60-601-1

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Test instructions / Service Card IPM-L

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Workstation Neonatal Care

Function and condition test

Test Result Test Result Test Result Test Result

Normal condition (N.C.) DC: The value must not exceed 10 µA. Normal condition (N.C.) DC IEC 60-601-1

[________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

[________µA]

UL 60-601-1 Test Result Test Result

4

Normal condition (N.C.) DC: The value must not exceed 10 µA. Normal condition (N.C.) DC UL 60-601-1

[________µA]

Normal condition (N.C.) AC: The value must not exceed 100 µA. Normal condition (N.C.) AC UL 60-601-1

[________µA]

Function and condition test This chapter contains condition and function tests.

4.1

General condition check Prerequisites

4.1.1

Medical device Test Result

4.1.2

The medical device has been fully set up according to the instructions for use.

Check that the medical device is clean and undamaged. Medical device

[________OK]

Accompanying documents Test

Check that all accompanying documents are present (according to the operator). Only applicable in Germany: Check that the medical product logs are present (according to the operator).

Result

[________OK]

Rating plates, labels and notices on the medical device

No.1612_0000007473

4.1.3

Accompanying documents

NOTE Observe the different cockpit types when checking.

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Test instructions / Service Card IPM-L

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Revision 20.0

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9500560