CARESCAPE ONE Installation and Maintenance Checkforms 3rd Edition Sw ver 3

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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Contents About the check forms ... 5 Revision history ... 5 Planned maintenance schedules... 5 Service requirements... 6 Manufacturer responsibility ... 7 CARESCAPE ONE system installation check ... 9 CARESCAPE ONE system maintenance check... 13

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About the check forms This document contains installation and maintenance check forms for CARESCAPE ONE. 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 provide a signed copy 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: ●

CARESCAPE ONE

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CARESCAPE Dock F0

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CARESCAPE ECG

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CARESCAPE Pressure

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CARESCAPE Temperature

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CARESCAPE SpO2

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CARESCAPE SpO2 - Masimo

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CARESCAPE SpO2 - Nellcor

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CARESCAPE CO2

Revision history Revision

Description

1st Edition

Initial release.

2nd Edition

Updated title page software version, ECG functional check acceptance criteria, and EC Rep contact information on the back cover.

3rd Edition

Updated CARESCAPE Planned maintenance schedules and the installation Electrical safety tests sections. Updated the Electrical safety tests - Corrective maintenance check and the Electrical safety tests - Planned maintenance check sections. Deleted the installation Parameter functional check section and the EC REP and CE Mark symbols from the last page.

Planned maintenance schedules See the user’s manual for the instructions about the cleaning and care schedules and about the regular calibration check intervals.

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Service personnel must perform the planned maintenance check as follows: Device

Planned maintenance schedule

● CARESCAPE ONE

Every two years after installation.

● CARESCAPE Dock F0 ● CARESCAPE CO2 ● CARESCAPE SpO2 - Masimo ● CARESCAPE SpO2 - Nellcor ● CARESCAPE ECG

Every seven years after installation.

● CARESCAPE Pressure ● CARESCAPE SpO2 ● CARESCAPE Temperature

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. ●

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.

WARNING

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

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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.

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CARESCAPE ONE system installation check Customer:

Monitor type: CARESCAPE ONE

Service record #:

Software version:

Service engineer

Service Manual: 2098697–001

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

PASS = Test passed

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Manufacturer

Model/ Type/ Part No

Serial number/ ID

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

CARESCAPE ONE

Calibration due date

FAIL = Test failed

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Visual inspection Pass

Visual inspection

Fail

Comments

Check that all product labeling, markings and symbols are intact and readable. Check that the monitor and the connected devices do not have any visible damage. Check that the monitor and the connected peripheral devices are properly mounted with specified mounting solutions. Check that all mounting solution fasteners are intact, properly tightened, and correctly secured. Check that the power cord and power supply are properly secured. Check that the CARESCAPE Parameters are properly connected.

Electrical safety tests Electrical safety tests - Installation check The manufacturer has performed the electrical safety test for the monitor and measurement devices during final inspection. You do not have to perform the electrical safety tests during the installation checkout.

System functional check System functional check

Acceptance criteria

Alarm light

Power status indicator is lit. The blue, yellow and red alarm light blinks. The blue pause audio alarm indicator blinks.

Start-up

Green on/standby key is lit. Start-up screen briefly displays. Software package and version displays on welcoming screen are correct. Speaker gives an audible beep. Normal monitoring screen displays and there are no error messages displayed. Battery is fully charged.

Display: Picture quality

Text is readable, images are clear and brightness is adequate.

Display: Touchscreen control

Selected active parameter window opens the related menu.

CARESCAPE Parameter identification

Connected CARESCAPE Parameters display.

Status of connected devices

Host serial number and active software version are correct. Ordered licenses are enabled. CARESCAPE Parameters connected to the CARESCAPE ONE are correctly identified. Power line frequency is correctly configured.

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Pass

Fail

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System functional check

Acceptance criteria

CARESCAPE Dock F0 is charging a battery

CARESCAPE Dock F0 is charging a battery.

Pass

Fail

Test completion

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CARESCAPE ONE system maintenance check Customer:

Monitor type: CARESCAPE ONE

Service record #:

Software version:

Service engineer

Service Manual: 2098697–001

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

PASS = Test passed

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Manufacturer

Model/ Type/ Part No

Serial number/ ID

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

CARESCAPE ONE

Calibration due date

FAIL = Test failed

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Visual inspection Pass

Visual inspection

Fail

Comments

Check that all product labeling, markings and symbols are intact and readable. Check that the monitor and the connected devices do not have any visible damage. Check that the monitor and the connected peripheral devices are properly mounted with specified mounting solutions. Check that all mounting solution fasteners are intact, properly tightened, and correctly secured. Check that the power cord and power supply are properly secured. Check that the CARESCAPE Parameters are properly connected.

Electrical safety tests Electrical safety tests - Corrective maintenance check Is the front bezel and/or top/bottom housings opened? Yes

Perform the electrical safety tests.

No

If the front bezel and/or the top/bottom housings were not opened, you do not have to perform the electrical safety tests. To continue the maintenance check, mark the Electrical safety test - Completion as N. A. (last section of the electrical safety tests), and proceed to the functional checks.

Electrical safety tests - Planned maintenance check Device

Test frequency

● CARESCAPE ONE

Perform the electrical safety tests if it has been more than two years since the electrical safety tests were last completed.

● CARESCAPE Dock F0 ● CARESCAPE CO2 ● CARESCAPE SpO2 - Masimo ● CARESCAPE SpO2 - Nellcor ● CARESCAPE ECG ● CARESCAPE Pressure

Perform the electrical safety tests if it has been more than seven years since the electrical safety tests were last completed.

● CARESCAPE SpO2 ● CARESCAPE Temperature

Pass

Electrical safety tests - CARESCAPE Dock F0

Fail

Power outlet is correctly wired. Power cord and plug are undamaged.

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Ground leakage current test CARESCAPE ONE and CARESCAPE Dock F0

Observed result µ

Acceptance criteria

GROUND, Neutral closed, Normal polarity

< 1000µ

GROUND, Neutral closed, Reverse polarity

< 1000µ

GROUND, Neutral open, Normal polarity

< 1000µ

Chassis leakage current to the ePort connection Observed result test µ CARESCAPE ONE and CARESCAPE Dock F0

Acceptance criteria

CHASSIS, Neutral closed, Normal polarity

< 100µ

CHASSIS, Neutral closed, Reverse polarity

< 100µ

CHASSIS, Neutral closed, Reverse polarity, GND open

< 100µ

CHASSIS, Neutral open, Normal polarity

< 500µ

Chassis leakage current to the Ethernet connection test CARESCAPE ONE and CARESCAPE Dock F0

Observed result µ

Acceptance criteria

CHASSIS, Neutral closed, Normal polarity

< 100µ

CHASSIS, Neutral closed, Reverse polarity

< 100µ

CHASSIS, Neutral closed, Reverse polarity, GND open

< 100µ

CHASSIS, Neutral open, Normal polarity

< 500µ Observed result μ

Electrical safety tests - system CARESCAPE Parameter: S/N:

Acceptance criteria

Pass

Fail

Pass

Fail

Pass

Fail

Pass

Fail

Pass

Fail

Patient (source) leakage current tests, using a test body. LEAD-GND, RL lead, Neutral closed, Normal polarity

≤ 10 μ

LEAD-GND, RL lead, Neutral closed, Reversed polarity

≤ 10 μ

LEAD-GND, RL lead, Neutral open, Normal polarity

≤ 50 μ

Patient (sink) leakage current test. LEAD-ISO, RL lead, Neutral closed, Normal polarity

≤ 50 μ

LEAD-ISO, RL lead, Neutral closed, Reversed polarity

≤ 50 μ

LEAD-ISO, RL lead, Neutral open, Normal polarity

≤ 50 μ Observed result μ

Electrical safety tests - system CARESCAPE Parameter: S/N:

Acceptance criteria

Patient (source) leakage current tests, using a test body. LEAD-GND, RL lead, Neutral closed, Normal polarity

≤ 10 μ

LEAD-GND, RL lead, Neutral closed, Reversed polarity

≤ 10 μ

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Observed result μ

Electrical safety tests - system CARESCAPE Parameter: S/N:

Acceptance criteria

Pass

Fail

Pass

Fail

Pass

Fail

Pass

Fail

≤ 50 μ

LEAD-GND, RL lead, Neutral open, Normal polarity Patient (sink) leakage current test. LEAD-ISO, RL lead, Neutral closed, Normal polarity

≤ 50 μ

LEAD-ISO, RL lead, Neutral closed, Reversed polarity

≤ 50 μ

LEAD-ISO, RL lead, Neutral open, Normal polarity

≤ 50 μ Observed result μ

Electrical safety tests - system CARESCAPE Parameter: S/N:

Acceptance criteria

Patient (source) leakage current tests, using a test body. LEAD-GND, RL lead, Neutral closed, Normal polarity

≤ 10 μ

LEAD-GND, RL lead, Neutral closed, Reversed polarity

≤ 10 μ

LEAD-GND, RL lead, Neutral open, Normal polarity

≤ 50 μ

Patient (sink) leakage current test. LEAD-ISO, RL lead, Neutral closed, Normal polarity

≤ 50 μ

LEAD-ISO, RL lead, Neutral closed, Reversed polarity

≤ 50 μ

LEAD-ISO, RL lead, Neutral open, Normal polarity

≤ 50 μ Observed result μ

Electrical safety tests - system CARESCAPE Parameter: S/N:

Acceptance criteria

Patient (source) leakage current tests, using a test body. LEAD-GND, RL lead, Neutral closed, Normal polarity

≤ 10 μ

LEAD-GND, RL lead, Neutral closed, Reversed polarity

≤ 10 μ

LEAD-GND, RL lead, Neutral open, Normal polarity

≤ 50 μ

Patient (sink) leakage current test. LEAD-ISO, RL lead, Neutral closed, Normal polarity

≤ 50 μ

LEAD-ISO, RL lead, Neutral closed, Reversed polarity

≤ 50 μ

LEAD-ISO, RL lead, Neutral open, Normal polarity

≤ 50 μ Observed result μ

Electrical safety tests - system CARESCAPE Parameter: S/N:

Acceptance criteria

Patient (source) leakage current tests, using a test body. LEAD-GND, RL lead, Neutral closed, Normal polarity

≤ 10 μ

LEAD-GND, RL lead, Neutral closed, Reversed polarity

≤ 10 μ

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Observed result μ

Electrical safety tests - system CARESCAPE Parameter: S/N:

Acceptance criteria

Pass

Fail

Pass

Fail

Pass

Fail

Pass

Fail

Pass

Fail

≤ 50 μ

LEAD-GND, RL lead, Neutral open, Normal polarity Patient (sink) leakage current test. LEAD-ISO, RL lead, Neutral closed, Normal polarity

≤ 50 μ

LEAD-ISO, RL lead, Neutral closed, Reversed polarity

≤ 50 μ

LEAD-ISO, RL lead, Neutral open, Normal polarity

≤ 50 μ Observed result μ

Electrical safety tests - single CARESCAPE Parameter: S/N:

Acceptance criteria

Patient (sink) leakage current test. DUAL, CHASSIS DUAL, Neutral closed, OUTLET OFF

≤ 50 μ

DUAL, CHASSIS DUAL, Neutral closed, Reversed polarity

≤ 50 μ Observed result μ

Electrical safety tests - single CARESCAPE Parameter: S/N:

Acceptance criteria

Patient (sink) leakage current test. DUAL, CHASSIS DUAL, Neutral closed, OUTLET OFF

≤ 50 μ

DUAL, CHASSIS DUAL, Neutral closed, Reversed polarity

≤ 50 μ Observed result μ

Electrical safety tests - single CARESCAPE Parameter: S/N:

Acceptance criteria

Patient (sink) leakage current test. DUAL, CHASSIS DUAL, Neutral closed, OUTLET OFF

≤ 50 μ

DUAL, CHASSIS DUAL, Neutral closed, Reversed polarity

≤ 50 μ Observed result μ

Electrical safety tests - single CARESCAPE Parameter: S/N:

Acceptance criteria

Patient (sink) leakage current test. DUAL, CHASSIS DUAL, Neutral closed, OUTLET OFF

≤ 50 μ

DUAL, CHASSIS DUAL, Neutral closed, Reversed polarity

≤ 50 μ

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Observed result μ

Electrical safety tests - single CARESCAPE Parameter: S/N:

Acceptance criteria

Pass

Fail

N.A.

Fail

Pass

Fail

Patient (sink) leakage current test. DUAL, CHASSIS DUAL, Neutral closed, OUTLET OFF

≤ 50 μ

DUAL, CHASSIS DUAL, Neutral closed, Reversed polarity

≤ 50 μ Pass

Electrical safety test - Completion Test completion

System functional check System functional check

Acceptance criteria

Alarm light

Power status indicator is lit. The blue, yellow and red alarm light blinks. The blue pause audio alarm indicator blinks.

Start-up

Green on/standby key is lit. Start-up screen briefly displays. Software package and version displays on welcoming screen are correct. Speaker gives an audible beep. Normal monitoring screen displays and there are no error messages displayed. Battery is fully charged.

Display: Picture quality

Text is readable, images are clear and brightness is adequate.

Display: Touchscreen control

Selected active parameter window opens the related menu.

CARESCAPE Parameter identification

Connected CARESCAPE Parameters display.

Status of connected devices

Host serial number and active software version are correct. Ordered licenses are enabled. CARESCAPE Parameters connected to the CARESCAPE ONE are correctly identified. Power line frequency is correctly configured.

CARESCAPE Dock F0 is charging a battery

CARESCAPE Dock F0 is charging a battery.

Test completion

Parameter functional check

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ECG functional check Tasks

Acceptance criteria

Normal sinus rhythm

ECG II, VI, and aVL waveforms are shown and are noise-free.

Observed result

Pass

N.A.

Fail

Observed result

Pass

N.A.

Fail

Heart rate is 80 ± 5 BPM Audible QRS tone is heard. All 12 ECG leads are available and are noise-free. Pacemaker detection

Pacemaker spikes are shown on the ECG waveform. Heart rate is 80 ± 1 BPM

Asystole detection

Asystole alarm is shown on the screen. Heart rate is 80 ± 1 BPM and is a normal sinus rhythm.

Leads off detection without the RA/R leadwire

Lead II disappears from the screen and RA/R lead off message appears. Lead II is replaced by Lead III on the screen after the RA/R leadwire is disconnected. Lead III is replaced by Lead II on the screen after the RA/R leadwire is reconnected.

Test completion Impedance respiration functional check Tasks

Acceptance criteria

Respiration rate

RESP waveform is shown. RR value is 20 ± 5 breaths per minute.

Apnea detection

RESP waveform is shown as a flat line. An Apnea alarm is activated. RR value is 20 ± 5 breaths per minute.

Test completion

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Invasive pressure functional check Tasks

Acceptance criteria

Zeroing

Zeroing followed by a Zeroed message is shown.

Static pressure

Pressure line appears as a flat line.

Observed result

Pass

N.A.

Fail

Observed result

Pass

N.A.

Fail

Observed result

Pass

N.A.

Fail

Pressure value is 200 ± 4 mmHg/26.7 ± 0.5 kPa. Pressure waveform

Pressure waveform and Sys/Dia (Mean) values 120/80 mmHg / 16/10.7 kPa are shown in the related parameter window.

Test completion Temperature functional check Tasks

Acceptance criteria

T1 temperature channel

The temperature value matches the configured simulator value ± 0.1°C/ ± 0.2°F and that there are no error messages shown on the monitor screen.

T2 temperature channel

The temperature value matches the configured simulator value ± 0.1°C/ ± 0.2°F and that there a no error messages shown on the monitor screen.

Test completion SpO2 functional check Tasks

Acceptance criteria

SpO2 value

The SpO2 value is shown in the parameter window.

Plethysmographic waveform

A plethysmographic waveform is shown on the monitor screen.

Test completion

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