CARESCAPE ONE Installation and Maintenance Checkforms sw ver 3.2 2nd edition

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

●

CARESCAPE Pressure

●

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 rSO2 - INVOS

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CARESCAPE CO2 - LoFlo

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CARESCAPE CO2 - Microstream

Revision history Revision

Description

1st edition

Initial release.

2nd edition

Updated the electrical safety test planned maintenance check test frequency for CARESCAPE rSO2 - INVOS.

Planned maintenance schedules Service personnel must perform the planned maintenance check as follows:

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Device

Planned maintenance schedule

● CARESCAPE ONE

Every two years from the date of installation.

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

● Every two years from the date

of installation, perform the visual inspection and functional checks.

● CARESCAPE Pressure ● CARESCAPE SpO2

● Perform the patient leakage current

tests as required by local policy, or a minimum of once within seven years of installation and every year after seven years.

● CARESCAPE Temperature

● CARESCAPE rSO2 - INVOS

● Every year from the date of

installation. ● Every five years, replace the

CARESCAPE rSO2 parameter module. ● CARESCAPE CO2 - Microstream

● 1,200 operating hours after

installation or one year after installation, whichever comes first. ● Following the initial gas calibration,

calibrate gases every 4,000 operating hours or annually, whichever comes first. ● Every 30,000 operating hours,

starting from the installation date, return the CARESCAPE Microstream CO2 to GE Healthcare for manufacturer replacement of the parameter device’s internal pump and its IR sensor.

NOTE

The manufacturer does not, in any manner, assume the responsibility for performing the specified 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 service manuals and related Medtronic instructions for use 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,

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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. ●

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

●

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

●

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.

●

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

WARNING

PATIENT SAFETY. Do not perform any service activities on the monitor in the patient vicinity while a patient is being connected to the monitor. Otherwise there is a risk of compromised patient safety.

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.

●

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: 5825339

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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Pass

User and service manuals Only for CARESCAPE monitoring system with CARESCAPE Software version 3.2

Fail

Customer has all user and service manuals for the CARESCAPE monitoring system with CARESCAPE Software version 3.2 and the customer knows how to use them.

Visual inspection Pass

Visual inspection

Fail

Comments

All product labeling, markings and symbols are intact and readable. The monitor, connected devices, and device cables have no cracks or breaks, dirt, loose connectors, corroded or bent pins, fluid contamination, or other visible damage. The monitor and the connected devices are properly mounted with specified mounting solutions. All mounting solution fasteners are intact, properly tightened, and correctly secured. The power cord and power supply are properly secured. 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.

Pass

N.A.

Fail

● Blue, yellow and red alarm light

blinks. ● Blue pause audio alarm indicator

blinks. Start-up

● Green on/standby button 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. ● The language of the clinical user

interface is correct. ● The correct time appears on the

normal monitoring screen. ● Battery is fully charged.

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System functional check

Acceptance criteria

Display: Picture quality

● Text is readable, images are clear

Pass

N.A.

Fail

and brightness is adequate. Display: Touchscreen control

● Selected active parameter window

opens the related menu. CARESCAPE Parameter identification

● Connected CARESCAPE Parameters

Status of connected devices

● CARESCAPE ONE host serial number

display. and active software version are correct. ● CARESCAPE Parameters connected

to the CARESCAPE ONE are correctly identified. ● Power line frequency is correctly

configured. Status and identification of CARESCAPE SpO2 - Masimo device (host monitor only)

● Pi/PVi or SpHb Masimo rainbow

SET parameter displays on the host monitor. ● Connected CARESCAPE SpO2 -

Masimo is correctly identified on the host monitor. Status and identification of rSO2 device(s) (host monitor only)

● Connected rSO2 parameter(s) display

on the host monitor. ● Connected rSO2 device(s) are

correctly identified on the host monitor. CARESCAPE Dock F0 is charging a battery

● CARESCAPE Dock F0 is charging a

battery.

Test completion

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CARESCAPE ONE system maintenance check Customer:

Monitor type: CARESCAPE ONE

Service record #:

Software version:

Service engineer

Service Manual: 5825339

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

All product labeling, markings and symbols are intact and readable. The monitor, connected devices, and device cables have no cracks or breaks, dirt, loose connectors, corroded or bent pins, fluid contamination, or other visible damage. The monitor and the connected devices are properly mounted with specified mounting solutions. All mounting solution fasteners are intact, properly tightened, and correctly secured. The power cord and power supply are properly secured. 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 - LoFlo ● 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 ● CARESCAPE rSO2 - INVOS

Perform the electrical safety tests if it has been more than one year since the electrical safety tests were last completed. 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:

Pass

Fail

Pass

N.A.

Fail

Pass

N.A.

Fail

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

Electrical safety test - Completion Test completion

System functional check System functional check

Acceptance criteria

Alarm light

● Power status indicator is lit. ● Blue, yellow and red alarm light

blinks. ● Blue pause audio alarm indicator

blinks. Start-up

● Green on/standby button 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. ● The language of the clinical user

interface is correct. ● The correct time appears on the

normal monitoring screen. ● 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

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● Connected CARESCAPE Parameters

display.

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System functional check

Acceptance criteria

Pass

Status of connected devices

● CARESCAPE ONE host serial number

N.A.

Fail

and active software version are correct. ● CARESCAPE Parameters connected

to the CARESCAPE ONE are correctly identified. ● Power line frequency is correctly

configured. Status and identification of CARESCAPE SpO2 - Masimo device (host monitor only)

● Pi/PVi or SpHb Masimo rainbow

SET parameter displays on the host monitor. ● Connected CARESCAPE SpO2 -

Masimo is correctly identified on the host monitor. Status and identification of rSO2 device(s) (host monitor only)

● Connected rSO2 parameter(s) display

on the host monitor. ● Connected rSO2 device(s) are

correctly identified on the host monitor. CARESCAPE Dock F0 is charging a battery

● CARESCAPE Dock F0 is charging a

battery.

Test completion

Parameter functional check 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

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.

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ECG functional check Tasks

Acceptance criteria

Leads off detection without the RA/R leadwire

Lead II disappears from the screen and RA/R lead off message appears.

Observed result

Pass

N.A.

Fail

Observed result

Pass

N.A.

Fail

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 First CARESCAPE Pressure

N.A.

Serial number

Serial number of the CARESCAPE Pressure 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

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

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