Module Frames and Modules Technical Manual June 2009

Trademarks Listed below are GE Medical Systems Information Technologies and GE Healthcare Finland Oy trademarks used in this document. All other product and company names contained herein are the property of their respective owners. MUSE, TRAM, TRIM KNOB, and UNITY NETWORK are trademarks of GE Medical Systems Information Technologies registered in the United States Patent and Trademarks Office. 12SL, 12RL, ApexPro, AWARE, CARESCAPE, and EK-Pro are trademarks of GE Medical Systems Information Technologies. Datex, Ohmeda, D-lite, D-lite+, Pedi-lite, Pedi-lite+, D-fend, D-fend+, Mini D-fend, OxyTip+, MemCard, EarSat, Entropy, FingerSat, FlexSat, PatientO2, and Patient Spirometry are trademarks of GE Healthcare Finland Oy.

NOTE: The Patient Data Module is described in promotional materials as the CARESCAPE Patient Data Module. NOTE: A portion of the Entropy software is derived from the RSA Data Security, Inc. MD5 Message-DIgest Algorithm.

Product availability Some of the products mentioned in this manual may not be available in all countries. Please, consult your local representative for the availability.

Master table of contents Module Frames and Modules Technical Manual Order code: # 2040387-004, CD # 2040386-006, paper 1st edition / Revision A

Description

Tab

Introduction PRESTN Modules, E-PRESTN, E-RESTN, E-PRETN Patient Side Modules, E-PSM, E-PSMP

1

Cardiac Output Modules E-COP and E-COPSv

2

Pressure Module, E-P, Pressure Temp Module, E-PT, Dual Pressure Module, E-PP

3

Masimo Module, E-MASIMO

4

Nellcor Compatible Saturation Module, E-NSATX

5

Compact Airway Modules, E-CAiOVX, E-CAiOV, E-CAiO, E-COVX, E-COV and E-CO

6

Single-width Airway Module, E-miniC

7

Entropy Module, E-ENTROPY

8

EEG Module, E-EEG and EEG Headbox, N-EEG

9

BIS Module, E-BIS

10

NeuroMuscular Transmission Module, E-NMT

11

Module Frames F5, F7

12

PDM Module

13

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For your notes:

Document no. M1153491-005

Table of contents

Table of contents 1

Introduction 1.1

1.2

1.3

Introduction-1

Manual Information...Introduction-1 1.1.1 Revision history...Introduction-1 1.1.2 Intended purpose (Indications for use)...Introduction-1 1.1.3 Manual purpose...Introduction-1 1.1.4 Intended audience...Introduction-1 1.1.5 Ordering manuals...Introduction-1 1.1.6 Related documentation...Introduction-1 1.1.7 Naming conventions...Introduction-2 1.1.8 Abbreviations and conventions used...Introduction-2 Safety information...Introduction-2 1.2.1 Quality management system...Introduction-2 1.2.2 Responsibility of the manufacturer...Introduction-2 1.2.3 Safety message signal words...Introduction-3 1.2.4 Danger safety messages...Introduction-3 1.2.5 Warning safety messages...Introduction-3 1.2.6 Caution safety messages...Introduction-4 1.2.7 Notice safety messages...Introduction-4 1.2.8 Equipment symbols...Introduction-5 Service information...Introduction-7 1.3.1 Service requirements...Introduction-7 1.3.2 Equipment identification...Introduction-7 1.3.3 Sample serial number label...Introduction-8 1.3.4 Device plate location...Introduction-8 1.3.5 Access to Webmin...Introduction-9

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Introduction

1

Introduction

1.1 Manual Information 1.1.1 Revision history Each page of the document has the document part number and revision indicator at the bottom of the page. The revision indicator changes whenever the document is updated.

Revision 005

Comments A

Initial

1.1.2 Intended purpose (Indications for use) Refer to the CARESCAPE monitor user’s manuals for information about this device, including intended use of this device, important safety information and detailed instructions for clinical use of this product.

1.1.3 Manual purpose This manual contains technical information for service representatives and technical personnel so they can maintain, troubleshoot or repair the equipment to the assembly level. Use it as a guide for maintenance and electrical repairs considered field repairable. Where necessary the manual identifies additional sources of relevant information and technical assistance. This Module Frames and Modules Technical Manual is intended to be used in context with the CARESCAPE monitor technical manual. For installation instructions see the monitor’s technical manual. See the CARESCAPE monitor user’s manual for the instruction necessary to operate the equipment safely in accordance with its function and intended use.

Electromagnetic compatibility (EMC) Refer to the CARESCAPE monitor technical manual, Appendix A: for the Electromagnetic compatibility.

1.1.4 Intended audience This technical manual is intended for service representatives and technical personnel who maintain, troubleshoot or repair the products covered in this manual.

1.1.5 Ordering manuals A paper copy of this manual will be provided upon request. Contact your local GE representative and request the part number on the first page of the manual.

1.1.6 Related documentation • • • •

CARESCAPE monitor user’s manual CARESCAPE Monitors Clinical Reference Manual CARESCAPE monitor technical manual CARESCAPE monitor compatible devices supplement

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• • •

CARESCAPE monitor technical specification document CARESCAPE monitor supplies and accessories document Mounting Reference Guide

1.1.7 Naming conventions In this manual, the following naming conventions are used to refer to different modules and module categories:

• • •

PDM = Patient Data Module PSM = Patient Side Module, E-PSM and E-PSMP E-modules = all modules with prefix 'E-'

1.1.8 Abbreviations and conventions used Within this manual, special styles and formats are used to distinguish between terms viewed on screen, a button you must press, or a list of menu commands you must select: −

For technical documentation purposes, the abbreviation GE is used for the legal entity names, GE Medical Systems Information Technologies and GE Healthcare Finland Oy.

−

Names of hardware keys on the equipment, keypad, remote control, and modules are written in bold typeface: Zero All.

−

Menu items are written in bold italic typeface: ECG Setup.

−

Emphasized text is in italic typeface.

−

Menu options or control settings selected consecutively are separated by the > symbol: ECG Setup > AFIB.

−

When referring to different sections in this manual, section names are enclosed in double quotes: "Cleaning and care."

−

The word "select" means choosing and confirming.

−

Messages (alarm messages, informative messages) displayed on the screen are written inside single quotes: 'Learning'.

NOTE: Note statements provide application tips or other useful information.

Illustrations and names All illustrations in this manual are only examples, and may not necessarily reflect your system settings or data displayed in your system.

1.2 Safety information 1.2.1 Quality management system The quality management system complies with the international standards ISO 9001 and ISO 13485, and the Council Directive on Medical Devices 93/42/EEC.

1.2.2 Responsibility of the manufacturer GE is responsible for the effects of safety, reliability, and performance only if:

•

Assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE.

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Introduction

•

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

• •

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.

The manufacturer reserves the right to change product specifications without prior notice. Although the information in this manual is believed to be accurate and reliable, the manufacturer assumes no responsibility for its use. GE Healthcare assumes no responsibility for the use or reliability of its software in equipment that is not furnished by GE Healthcare. NOTE: Failure on the part of all responsible individuals, hospitals and institutions, employing the use of this device, to implement the recommended maintenance schedule may cause equipment failure and possible health hazards. 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.

1.2.3 Safety message signal words Signal words designate the severity of a potential hazard.

DANGER WARNING CAUTION

Danger indicates a hazardous situation that, if not avoided, will result in death or serious injury. No danger messages apply to this system. Warning indicates a hazardous situation that, if not avoided, could result in death or serious injury. Caution indicates a hazardous situation that, if not avoided, could result in minor or moderate injury. Notice: Indicates a hazardous situation not related to personal injury that, if not avoided, could result in property damage. NOTE: Provides application tips or other useful information to assure that you get the most from your equipment.

1.2.4 Danger safety messages No danger safety messages apply to this monitoring system.

1.2.5 Warning safety messages The following warning safety messages apply to this monitoring system:

•

WARNING - Keep the Compact Airway Module/Single-width Airway Module in the horizontal position when it is used. A tilted Compact Airway Module/Single-width Airway Module may cause erroneous readings and damage the module.

•

WARNING - Do not connect any external devices to the system other than those specified.

•

WARNING - After transferring or reinstalling the monitor, always check that it is properly connected and all parts are securely attached. Pay special attention to this in case of stacked mounting.

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•

WARNING - If you accidentally drop the monitor, modules or frames, have them checked by authorized service personnel prior to clinical use.

•

WARNING - The user may only perform maintenance procedures specifically described in this manual.

•

WARNING - When detaching modules, be careful not to drop them. Always support with one hand while pulling out with the other.

•

WARNING - Use only approved accessories, mounts and defibrillator-proof cables and invasive pressure transducers. For a list of approved supplies and accessories, see the "CARESCAPE monitor supplies and accessories document" delivered with the monitor. Other cables, transducers and accessories may cause a safety hazard, damage the equipment or system, result in increased emissions or decreased immunity of the equipment or system or interfere with the measurement. Protection against cardiac defibrillator discharge is due in part to the accessories for pulse oximetry (SpO2), temperature (T) and invasive pressure (P) measurement.

•

WARNING - Pins of connectors identified with the ESD warning symbol should not be touched. Connections should not be made to these connectors unless ESD precautionary procedures are used. See "Safety precautions: ESD precautionary procedures" in the "CARESCAPE monitor user’s manual" for details.

•

WARNING - LEAKAGE CURRENT TEST - When interfacing with other equipment, a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients.

•

WARNING - PROTECTED LEADWIRES - Only use protected leadwires and patient cables with this monitor. The use of unprotected leadwires and patient cables creates the potential for making an electrical connection to ground or to a high voltage power source which can cause serious injury or death to the patient. [Note this also includes a graphic depicting the correct and incorrect leadwire types.]

•

WARNING - Make sure that the leadwire set clips or snaps do not touch any electrically conductive material including earth.

•

WARNING - Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

1.2.6 Caution safety messages The following caution safety messages apply to this monitoring system:

•

CAUTION - Do not store or use the monitor outside the temperature and humidity ranges specified in the "CARESCAPE monitor technical specification document ".

•

CAUTION - Ensure that the plug-in modules are properly orientated (i.e. the module release latch is facing downward) before insertion.

•

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 such products. If you have questions concerning disposal of the product, please contact GE or its representatives.

•

CAUTION - MAINTENANCE - Regular preventive maintenance should be carried out annually. You are responsible for any requirements specific to your country.

1.2.7 Notice safety messages The following notice safety messages apply to this monitoring system:

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Introduction

•

NOTICE - The warranty does not cover damages resulting from the use of accessories and consumables from other manufacturers.

• •

NOTICE - Turn of power before connecting any ePort devices. NOTICE - BATTERY POWER - If a device equipped with an optional battery pack will not be used or not be connected to the power line for a period of over six months, remove the battery.

1.2.8 Equipment symbols Safety symbols NOTE: The following safety-related symbols appear on one or more of the devices. ATTENTION: Consult accompanying documents.

Consult operating instructions.

Electrostatic sensitive device. Connections should not be made to this device unless ESD precautionary procedures are followed. Type BF (IEC 60601-1) protection against electric shock. Non-isolated applied part suitable for intentional external and internal application to the patient, excluding direct cardiac application. Type BF (IEC 60601-1) defibrillator-proof protection against electric shock. Isolated (floating) applied part suitable for intentional external and internal application to the patient including direct cardiac application. Type CF (IEC 60601-1) protection against electric shock. Non-isolated applied part suitable for intentional external and internal application to the patient, excluding direct cardiac application. Type CF (IEC 60601-1) defibrillator-proof protection against electric shock. Isolated (floating) applied part suitable for intentional external and internal application to the patient including direct cardiac application.

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Device symbols Defibrillator synchronization connector port.

Gas inlet.

Gas outlet.



 

Battery

Communication

Zero all.

Power indicator.

Equipotentiality. Connect device to a potential equalization conductor.

Degree of ingress protection.

lbl p/n

Abbreviation for label part number

TYPE

Device type e.g. E-NMT

PN

Part number of the product Device serial number

-05

Batch or lot number Catalog or orderable part number.

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Introduction

European Union Declaration of Conformity.

Underwriters Laboratories product certification mark.

Prescriptive Device. USA only. For use by or on the order of

Rx ONLY U.S. a Physician, or persons licensed by state law. Rx Only



Prescriptive Device. USA only. For use by or on the order of a Physician, or persons licensed by state law. Date of manufacture. This symbol indicates the date of manufacture of this device. The first four digits identify the year and the last two digits identify the month. This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

1.3 Service information 1.3.1 Service requirements General service requirements and qualification requirements for the service personnel. Follow the service requirements listed below. −

Refer equipment servicing to GE authorized service personnel only.

−

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.

1.3.2 Equipment identification Every GE device has a unique serial number for identification. A sample of the information found on a serial number label is shown below.

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### ## ## #### # #

A

B

C

D

E

F

Description A

product code

B

year manufactured

C

fiscal week manufactured

D

production sequence number

E

manufacturing site

F

miscellaneous characteristic

1.3.3 Sample serial number label A sample of the information found on a serial number label of an E-modules device plate is shown below.

A B

Description A

Type: Device type e.g. E-NMT

B

SN:Serial number

1.3.4 Device plate location The device plate is located between the docking rails of the PDM module and on the inside of the module frames F5 and F7.

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Introduction

Figure 1

Device plate location, Patient Data Module and module frames

The device plate is located beside the docking rails of the E-PSM and E-PSMP modules and on the left side of the plug-in E-modules.

Figure 2

Device plate location, E-PSM and E-modules

1.3.5 Access to Webmin Webmin can be accessed locally through the CARESCAPE monitor or remotely from a configured service laptop connected to the CARESCAPE monitor. For information about Webmin, see the “CARESCAPE monitor technical manual” chapter 4, “Configuration”. Introduction - 9 Document no. M1153491-005

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Introduction - 10 Document no. M1153491-005

1 Hemodynamic Modules E-PRESTN, E-RESTN, E-PRETN, E-PSMP, E-PSM Technical Manual

Table of contents

Table of contents 1

Product overview 1.1 1.2

1.3

2

3

3.2 3.3 3.4

4.2 4.3

1-22

Replacement of planned maintenance parts... 1-22 3.1.1 Required parts... 1-22 3.1.2 Replacement procedures... 1-22 Visual inspections... 1-22 Electrical safety tests... 1-23 Functional check... 1-23 3.4.1 Setup... 1-23 3.4.2 ECG tests... 1-27 3.4.3 Impedance respiration tests... 1-27 3.4.4 Invasive pressure tests... 1-28 3.4.5 Temperature tests... 1-28 3.4.6 SpO2 tests... 1-28 3.4.7 NIBP tests... 1-29 3.4.8 Test completion... 1-30

Calibration and adjustments 4.1

1-20

STP/TP /ST-Settings... 1-20 2.1.1 Configuration... 1-20

Maintenance and checkout 3.1

4

Introduction... 1-1 Measurement principle... 1-2 1.2.1 ECG... 1-2 1.2.2 Respiration... 1-2 1.2.3 Invasive blood pressure... 1-2 1.2.4 Temperature... 1-2 1.2.5 Pulse oximetry... 1-3 1.2.6 NIBP... 1-5 Main components... 1-6 1.3.1 Controls and connectors... 1-6 1.3.2 E-PSM(P) and E-(P)RE(S)TN modules... 1-8 1.3.3 ECG board... 1-9 1.3.4 STP board... 1-11 1.3.5 NIBP board... 1-16

Configuration 2.1

1-1

1-31

Invasive pressure calibration... 1-31 4.1.1 Setup... 1-31 4.1.2 Procedure... 1-32 Temperature calibration... 1-33 4.2.1 Setup... 1-33 4.2.2 Procedure... 1-33 NIBP calibration... 1-34

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4.3.1 Setup... 1-35 4.3.2 Procedure... 1-35

5

Troubleshooting 5.1 5.2 5.3

5.4

5.5

6

6.2 6.3

7

Visual inspection... 1-38 Troubleshooting checklist... 1-38 Service Interface... 1-39 5.3.1 Configuration Information... 1-39 5.3.2 Device Information... 1-39 5.3.3 Log files... 1-39 Messages... 1-40 5.4.1 ECG... 1-40 5.4.2 Impedance respiration... 1-42 5.4.3 Invasive Pressure... 1-42 5.4.4 Temperature... 1-44 5.4.5 SpO2... 1-44 5.4.6 NIBP... 1-45 Troubleshooting chart... 1-49 5.5.1 Invasive Pressure... 1-49 5.5.2 Temperature... 1-49

Disassembly and reassembly 6.1

7.3

1-50

Disassembly guidelines... 1-50 6.1.1 ESD precautions... 1-50 6.1.2 Before disassembly... 1-50 6.1.3 Required tools... 1-51 Disassembling and reassembling procedure, E-PRESTN, E-PRETN, E-RESTN... 1-51 6.2.1 Removing the pump unit... 1-57 6.2.2 Replacing the NIBP air filter... 1-58 Disassembling and reassembling procedure, E-PSMP and E-PSM... 1-58 6.3.1 Removing the pump unit... 1-62 6.3.2 Removing the manifold unit... 1-63 6.3.3 Removing the module bus connector... 1-64 6.3.4 Replacing the NIBP air filter... 1-65

Service parts 7.1 7.2

1-38

1-66

Ordering parts... 1-66 E-PRESTN, E-PRETN, E-RESTN... 1-67 7.2.1 Front cover for E-PRESTN, E-PRETN, E-RESTN... 1-70 Patient Side Modules, E-PSM, E-PSMP... 1-72 7.3.1 Front panel labeling, E-PSM(P)... 1-73

Maintenance check form

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Hemodynamic Modules E-PRESTN, E-RESTN, E-PRETN, E-PSMP, E-PSM

1

Product overview

1.1 Introduction This document provides information for the maintenance and service of the Patient Side Modules E-PSMP and E-PSM, and the double-width plug-in hemodynamic modules, E-PRETN, E-PRESTN and E-RESTN. These modules provide general hemodynamic parameters.

Figure 1

Patient Side Module, E-PSMP, and Hemodynamic Module, E-PRESTN.

Parameter

E-PSMP

E-PSM

E-PRESTN

E-RESTN

E-PRETN

ECG

X

X

X

X

X

Impedance respiration

X

X

X

X

X

Two invasive blood pressures

X

Two temperatures

X

X

X

X

Pulse oximetry

X

X

X

X

NIBP

X

X

X

X

X

X X

X

Equipment safety symbols When displayed on the module, indicates that protection against cardiac defibrillator discharge is due in part to the accessories for pulse oximetry (SpO2), temperature (T) and invasive pressure (P) measurement

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