CARESCAPE Bxxx series Installation and Maintenance Checkforms 3rd edition sw ver 3 Nov 2018

Due to continuing product innovation, specifications in this manual are subject to change without notice. For technical documentation purposes, the abbreviation GE is used for the legal entity names, GE Medical Systems Information Technologies, Inc. and GE Healthcare Finland Oy.

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CARESCAPE B850, B650, B450, module frames, and acquisition modules

2109358-006 2018-11-28

Contents About the check forms ... 5 Planned maintenance schedules... 6 Service requirements... 6 Manufacturer responsibility ... 7 CARESCAPE B850 system installation check ... 9 CARESCAPE B850 maintenance check ... 15 CARESCAPE B650 installation check ... 19 CARESCAPE B650 maintenance check ... 25 CARESCAPE B450 installation check ... 29 CARESCAPE B450 maintenance check ... 35 Patient Data Module maintenance check ... 39 E-PiCCO module maintenance check ... 45 E-COPSv, E-COP modules maintenance check... 49 E-PP, E-PT modules maintenance check ... 53 E-MASIMO module maintenance check ... 57 E-NSATX module maintenance check ... 59 E-ENTROPY module maintenance check... 61 E-EEGX module and N-EEGX headbox maintenance check... 63 E-BIS module maintenance check ... 65 E-NMT module maintenance check... 67 CARESCAPE Respiratory Modules maintenance check ... 71 E-miniC module maintenance check... 75 F5, F7 Module frames maintenance check ... 77

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CARESCAPE B850, B650, B450, module frames, and acquisition modules

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About the check forms This document contains installation and maintenance check forms for CARESCAPE B850, B650, B450, module frames, and acquisition modules. Use the check forms during installation and maintenance check procedures. Record the results and activities on the check forms. Perform the installation check after the hardware installation and the platform configuration are completed, before taking the monitor into clinical use. Perform the maintenance check after any corrective maintenance and during the periodic maintenance. After a completed checkout archive the signed check form and give it to the customer. WARNING

SAFETY HAZARD. To avoid risks to personnel and patient, or damage to the equipment, only perform maintenance procedures described in this manual. Unauthorized modifications can lead to safety hazards.

Refer to the related service manual for detailed information regarding the checkout procedures. Refer to the user’s manual for important safety information regarding the whole system. The list below indicates the products (brands, models and descriptions as applicable) with which these check forms are to be used:

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CARESCAPE B850 MBC313

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CARESCAPE B650 MBB313

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CARESCAPE B450 MBA313

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CARESCAPE D19KT VER01

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Frame F5–01

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Frame F7–01

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E-COP-01

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E-COPSv-01

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E-PiCCO-00

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E-sCAiO-00

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E-sCAiOV-00

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E-sCAiOVX-00

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E-sCO-00

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E-sCOV-00

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E-sCOVX-00

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E-miniC-00

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E-MASIMO-00

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E-NSATX-00

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E-PP-00

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E-PT-00

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E-ENTROPY-01

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E-NMT-01

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E-EEGX MJD101

CARESCAPE B850, B650, B450, module frames, and acquisition modules

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N-EEGX MJS101

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E-BIS-01

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Patient Data Module

Planned maintenance schedules See the user manual for the instructions about the cleaning and care schedules and about the regular calibration check intervals. Service personnel must perform the planned maintenance check as follows: ●

For each monitor and module frame every two years after installation.

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For each PDM, E-miniC and Respiratory module every 12 months after installation.

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For all other modules every two years after installation.

The planned maintenance parts must be replaced according to the replacement interval specified in each maintenance check form. WARNING

Planned maintenance should be carried out at recommended interval. Failure to implement the recommended maintenance schedule may cause equipment failure and possible health hazards.

NOTE

The manufacturer does not, in any manner, assume the responsibility for performing the recommended maintenance schedule, unless an Equipment Maintenance Agreement exists. The sole responsibility rests with the individuals, hospitals, or institutions utilizing the device.

NOTE

The planned maintenance check must be performed to the whole patient monitoring system, including all the connected devices. See the related service manuals for information about the planned maintenance checks for the connected devices

Service requirements Follow the service requirements listed below.

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Refer servicing of the equipment to qualified service personnel only. Service personnel servicing this product must have an appropriate technical qualification, or equivalent work experience, and be familiar with the service requirements described in this manual and in any related service documentation. Service training for the product is recommended.

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Any unauthorized attempt to repair equipment under warranty voids that warranty.

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It is the user's responsibility to report the need for service to GE or to one of their authorized agents.

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Failure on the part of the responsible individual, hospital, or institution using this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.

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Regular maintenance, irrespective of usage, is essential to ensure that the equipment will always be functional when required.

CARESCAPE B850, B650, B450, module frames, and acquisition modules

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WARNING

Do not perform any service activities on the monitor in the patient vicinity while a patient is being connected to the monitor.

CAUTION

DISPOSAL. At the end of its service life, the product described in this manual, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of each product. If you have any questions concerning disposal of a product, please contact GE or its representatives.

Manufacturer responsibility GE is responsible for the effects on safety, reliability, and performance of the equipment only if:

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Assembly operations, extensions, readjustments, modifications, servicing, or repairs are carried out by authorized service personnel.

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The electrical installation of the relevant room complies with the requirements of the appropriate regulations.

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The equipment is used in accordance with the instructions for use.

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The equipment is installed, maintained and serviced in accordance with the instructions provided in the related technical manuals.

CARESCAPE B850, B650, B450, module frames, and acquisition modules

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CARESCAPE B850 system installation check Customer:

Monitor type: B850 MBC313

Service record #:

Software version:

Service engineer

Service Manual: 2109358–001

Monitor S/N:

Other devices connected to the monitor system Device

Serial number

Device

Serial number

Prior to testing, verify that all equipment is calibrated via “Cal” labeling and record Cal Due Dates. Measuring equipment used Equipment/ tool

Manufacturer

PASS = Test passed

Model/ Type/ Part No

Calibration due date

Serial number/ ID

N.A.= Test is not applicant, a component or a feature is not part of tested system. Pass

Visual inspection

FAIL = Test failed Fail

Comments

All product labeling, markings and symbols are intact and readable. The monitor and the connected devices are undamaged. The monitor and the connected peripheral devices are properly mounted with specified mounting solutions. The cables between the CPU and the connected devices are intact, properly connected and secured to the right connectors. The acquisition modules are properly connected and locked. Electrical safety tests Date of manufacture of the device: Is it less than 12 months since the device was manufactured? Yes:

Yes: you do not have to perform the electrical safety tests. To continue the installation check, mark the electrical safety test completion N.A. and proceed to Functional check.

No:

No: perform the electrical safety tests.

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CARESCAPE B850, B650, B450, module frames, and acquisition modules

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Pass

Electrical safety tests

Fail

Monitor Power outlet is correctly wired. Power cord and plug are undamaged and all conductors are properly connected. Ground integrity test Performed ground integrity test:

a.) Ground continuity test b.) Impedance of protective ground connection

Ground integrity task

Observed result ohms

Acceptance criteria

Without power cord

≤ 0.1 ohms

With power cord

≤ 0.2 ohms

Earth leakage current test

Observed result mA

Acceptance criteria

Normal polarity, Neutral closed (NC)

≤ 5 mA

Normal polarity, Neutral open (SFC)

≤ 10 mA

Reversed polarity, Neutral open (SFC)

≤ 10 mA

Reversed polarity, Neutral closed (NC)

≤ 5 mA

Touch current test

Observed result μA

Acceptance criteria

Normal polarity, Neutral closed, GND closed Normal condition (NC)

≤ 100 μA

Normal polarity, Neutral open, GND closed Single Fault Condition (SFC)

≤ 500 μA EN /IEC ≤ 300 μA UL

Normal polarity, Neutral closed, GND open Single Fault Condition (SFC)

≤ 500 μA EN /IEC ≤ 300 μA UL

Reversed polarity, Neutral closed, GND open Single Fault Condition (SFC)

≤ 500 μA EN /IEC ≤ 300 μA UL

Reversed polarity, Neutral open, GND closed Single Fault Condition (SFC)

≤ 500 μA EN /IEC ≤ 300 μA UL

Reversed polarity, Neutral closed, GND closed Normal condition (NC)

≤ 100 μA

Electrical safety tests Multiparameter module type:

Observed result μA (d.c.)

S/N:

ECG

Acceptance criteria

Pass

Fail

Pass

Fail

Pass

Fail

Pass

Fail

SpO2/ IP

Patient (source) leakage current tests, using a test body. Normal polarity, Neutral closed, GND closed, Normal condition (NC)

≤ 10 μA (d.c.)

Normal polarity, Neutral open, GND closed, Single Fault Condition (SFC)

≤ 50 μA (d.c.)

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CARESCAPE B850, B650, B450, module frames, and acquisition modules

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Electrical safety tests Multiparameter module type:

Observed result μA (d.c.)

S/N:

ECG

Acceptance criteria

Pass

Fail

Pass

Fail

SpO2/ IP

Normal polarity, Neutral closed, GND open, Single Fault Condition (SFC)

≤ 50 μA (d.c.)

Reversed polarity, Neutral closed, GND open, Single Fault Condition (SFC)

≤ 50 μA (d.c.)

Reversed polarity, Neutral open, GND closed, Single Fault Condition (SFC)

≤ 50 μA (d.c.)

Reversed polarity, Neutral closed, GND closed, Normal condition (NC)

≤ 10 μA (d.c.)

Patient (sink) leakage current test. Normal polarity, Neutral closed, GND closed, Normal condition (NC)

≤ 50 μA (d.c.)

Reversed polarity, Neutral closed, GND closed, Normal condition (NC)

≤ 50 μA (d.c.)

Electrical safety tests Module type:

Observed result μA (d.c.)

Acceptance criteria

S/N:

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Patient (source) leakage current tests, using a test body. Normal polarity, Neutral closed, GND closed, Normal condition (NC)

≤ 10 μA (d.c.)

Normal polarity, Neutral open, GND closed, Single Fault Condition (SFC)

≤ 50 μA (d.c.)

Normal polarity, Neutral closed, GND open, Single Fault Condition (SFC)

≤ 50 μA (d.c.)

Reversed polarity, Neutral closed, GND open, Single Fault Condition (SFC)

≤ 50 μA (d.c.)

Reversed polarity, Neutral open, GND closed, Single Fault Condition (SFC)

≤ 50 μA (d.c.)

Reversed polarity, Neutral closed, GND closed, Normal condition (NC)

≤ 10 μA (d.c.)

Patient (sink) leakage current test. Normal polarity, Neutral closed, GND closed, Normal condition (NC)

≤ 50 μA (d.c.)

Reversed polarity, Neutral closed, GND closed, Normal condition (NC)

≤ 50 μA (d.c.)

Electrical safety test

Pass

N.A.

Fail

Pass

N.A.

Fail

Test completion Functional check

Acceptance criteria

Alarm light

1. Primary display: ● Power indicator is lit. ● Blue, yellow and red alarm lights

illuminate. ● Pause audio alarm indicator illuminates.

2. Secondary display, if connected: ● Power indicator is lit. ● Blue, yellow and red alarm lights

illuminate. ● Pause audio alarm indicator illuminates.

Start-up

Monitor starts up normally without error messages.

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Displays: test both primary display and secondary display, if connected.

1. Picture quality: Text is readable, images are clear and brightness is adequate.

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2. Touchscreen control: Touchscreen is correctly calibrated and operates correctly. 3. Trim Knob: Selected menu opens and selected activity starts.

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CARESCAPE B850, B650, B450, module frames, and acquisition modules

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Functional check

Acceptance criteria

Status of connected devices

Host device and all connected devices are identified and configured correctly.

IX printers

Test page is printed to the selected printer.

Insite RSvP connectivity

The patient monitor is connected to the remote service server.

USB remote control: test both a hard key and the Trim Knob.

Selected menu opens and selected activity starts.

Mouse

Selected menu opens and selected activity starts.

Keyboard

Keyboard language configuration is correct.

Barcode reader

Data is correctly populated.

MC Network communication

Network symbol and the other monitor’s parameter data is correctly shown on the screen.

Citrix connection

The program is launched correctly.

Pass

N.A.

Fail

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Test completion Notes

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CARESCAPE B850 maintenance check Customer:

Monitor type: B850 MBC313

Service record #:

Software version:

Service engineer:

Module type:

S/N:

Service Manual: 2109358-001

Start date:

Corrective maintenance

Planned maintenance

S/N:

Prior to testing, verify that all equipment is calibrated via “Cal” labeling and record Cal Due Dates. Measuring equipment used Equipment/ tool

Manufacturer

PASS = Test passed

Model/ Type/ Part No

Calibration due date

Serial number/ ID

N.A.= Test is not applicant, a component or a feature is not part of tested system.

FAIL = Test failed

Replacement of planned maintenance parts

Replaced

N.A.

CPU battery (every 6th year) Pass

Visual inspection

Fail

Comments

All product labeling, markings and symbols are intact and readable. The monitor and the connected devices are undamaged. The monitor and the connected peripheral devices are properly mounted with specified mounting solutions. The cables between the CPU and the connected devices are intact, properly connected and secured to the right connectors. The acquisition modules are properly connected and locked. Pass

Electrical safety tests

Fail

Monitor Power outlet is correctly wired. Power cord and plug are undamaged and all conductors are properly connected. Ground integrity test Performed ground integrity test:

a.) Ground continuity test b.) Impedance of protective ground connection

Ground integrity task

Observed result ohms

Acceptance criteria

Without power cord

≤ 0.1 ohms

With power cord

≤ 0.2 ohms

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CARESCAPE B850, B650, B450, module frames, and acquisition modules

Pass

Fail

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Earth leakage current test

Observed result mA

Pass

Fail

Pass

Fail

Pass

N.A.

Fail

Pass

N.A.

Fail

Acceptance criteria

Normal polarity, Neutral closed (NC)

≤ 5 mA

Normal polarity, Neutral open (SFC)

≤ 10 mA

Reversed polarity, Neutral open (SFC)

≤ 10 mA

Reversed polarity, Neutral closed (NC)

≤ 5 mA

Touch current test

Observed result μA

Acceptance criteria

Normal polarity, Neutral closed, GND closed Normal condition (NC)

≤ 100 μA

Normal polarity, Neutral open, GND closed Single Fault Condition (SFC)

≤ 500 μA EN /IEC ≤ 300 μA UL

Normal polarity, Neutral closed, GND open Single Fault Condition (SFC)

≤ 500 μA EN /IEC ≤ 300 μA UL

Reversed polarity, Neutral closed, GND open Single Fault Condition (SFC)

≤ 500 μA EN /IEC ≤ 300 μA UL

Reversed polarity, Neutral open, GND closed Single Fault Condition (SFC)

≤ 500 μA EN /IEC ≤ 300 μA UL

Reversed polarity, Neutral closed, GND closed Normal condition (NC)

≤ 100 μA

Electrical safety test Test completion Functional check

Acceptance criteria

Alarm light

1. Primary display: ● Power indicator is lit. ● Blue, yellow and red alarm lights

illuminate. ● Pause audio alarm indicator illuminates.

2. Secondary display, if connected: ● Power indicator is lit. ● Blue, yellow and red alarm lights

illuminate. ● Pause audio alarm indicator illuminates.

Start-up

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Monitor starts up normally without error messages.

CARESCAPE B850, B650, B450, module frames, and acquisition modules

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Functional check

Acceptance criteria

Displays: test both primary display and secondary display, if connected.

1. Picture quality: Text is readable, images are clear and brightness is adequate.

Pass

N.A.

Fail

-

2. Touchscreen control: Touchscreen is correctly calibrated and operates correctly. 3. Trim Knob: Selected menu opens and selected activity starts. Status of connected devices

Host device and all connected devices are identified and configured correctly.

IX printers

Test page is printed to the selected printer.

Insite RSvP connectivity

The patient monitor is connected to the remote service server.

USB remote control: test both a hard key and the Trim Knob.

Selected menu opens and selected activity starts.

Mouse

Selected menu opens and selected activity starts.

Keyboard

Keyboard language configuration is correct.

Barcode reader

Data is correctly populated.

MC Network communication

Network symbol and the other monitor’s parameter data is correctly shown on the screen.

Citrix connection

The program is launched correctly.

-

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Test completion Notes

Used service parts

Signature

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Date

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CARESCAPE B850, B650, B450, module frames, and acquisition modules

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CARESCAPE B650 installation check Customer:

Monitor type: B650 MBB313

Service record #:

Software version:

Service engineer

Service Manual: 2109358-002

Monitor S/N:

Other devices connected to the monitor system Device

Serial number

Device

Serial number

Prior to testing, verify that all equipment is calibrated via “Cal” labeling and record Cal Due Dates. Measuring equipment used Equipment/ tool

Manufacturer

PASS = Test passed

Model/ Type/ Part No

Serial number/ ID

N.A.= Test is not applicant, a component or a feature is not part of tested system. Pass

Visual inspection

Calibration due date

FAIL = Test failed Fail

Comments

All product labeling, markings and symbols are intact and readable. The monitor and the connected devices are undamaged. The monitor and the connected peripheral devices are properly mounted with specified mounting solutions. The cables between the patient monitor and the connected devices are intact, properly connected and secured to the right connectors. The acquisition modules are properly connected and locked. The pivoting module frame and battery door are properly locked. Electrical safety tests Date of manufacture of the device: Is it less than 12 months since the device was manufactured? Yes:

Yes: you do not have to perform the electrical safety tests. To continue the installation check, mark the electrical safety test completion N.A. and proceed to Functional check.

No:

No: perform the electrical safety tests.

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CARESCAPE B850, B650, B450, module frames, and acquisition modules

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Pass

Electrical safety tests

Fail

Monitor Power outlet is correctly wired. Power cord and plug are undamaged and all conductors are properly connected. Ground integrity test Performed ground integrity test:

a.) Ground continuity test b.) Impedance of protective ground connection

Ground integrity task

Observed result ohms

Acceptance criteria

Without power cord

≤ 0.1 ohms

With power cord

≤ 0.2 ohms

Earth leakage current test

Observed result mA

Acceptance criteria

Normal polarity, Neutral closed (NC)

≤ 5 mA

Normal polarity, Neutral open (SFC)

≤ 10 mA

Reversed polarity, Neutral open (SFC)

≤ 10 mA

Reversed polarity, Neutral closed (NC)

≤ 5 mA

Touch current test

Observed result μA

Acceptance criteria

Normal polarity, Neutral closed, GND closed Normal condition (NC)

≤ 100 μA

Normal polarity, Neutral open, GND closed Single Fault Condition (SFC)

≤ 500 μA EN /IEC ≤ 300 μA UL

Normal polarity, Neutral closed, GND open Single Fault Condition (SFC)

≤ 500 μA EN /IEC ≤ 300 μA UL

Reversed polarity, Neutral closed, GND open Single Fault Condition (SFC)

≤ 500 μA EN /IEC ≤ 300 μA UL

Reversed polarity, Neutral open, GND closed Single Fault Condition (SFC)

≤ 500 μA EN /IEC ≤ 300 μA UL

Reversed polarity, Neutral closed, GND closed Normal condition (NC)

≤ 100 μA

Electrical safety tests Multiparameter module type:

Observed result μA (d.c.)

S/N:

ECG

Acceptance criteria

Pass

Fail

Pass

Fail

Pass

Fail

Pass

Fail

SpO2/ IP

Patient (source) leakage current tests, using a test body. Normal polarity, Neutral closed, GND closed, Normal condition (NC)

≤ 10 μA (d.c.)

Normal polarity, Neutral open, GND closed, Single Fault Condition (SFC)

≤ 50 μA (d.c.)

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CARESCAPE B850, B650, B450, module frames, and acquisition modules

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