B40i and B20i Technical Reference Manual Rev C

B40i/B20i Patient Monitor Technical Reference Manual

0537

Conformity according to the Council Directive 93/42/EEC concerning Medical Devices amended by 2007/47/EC. All specifications subject to change without notice. Order code 2088566-001 Revision C 28 March, 2021 Manufacturer address: GE Healthcare Finland Oy Kuortaneenkatu 2 FI-00510 Helsinki Finland

www.gehealthcare.com Copyright © 2021 General Electric Company. All rights reserved.

Classifications In accordance with IEC 60601-1 −

Class I and internally powered equipment - the type of protection against electric shock.

−

Type BF or CF equipment. The degree of protection against electric shock is indicated by a symbol on each parameter module.

−

Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

−

Continuous operation according to the mode of operation.

−

Portable Monitor

In accordance with IEC 60529 −

IP21 - degree of protection against harmful ingress of water.

In accordance with EU Medical Device Directive −

IIb.

In accordance with CISPR 11: −

Group 1 Class A;

•

Group 1 contains all ISM (Industrial, scientific and medical) equipment in which there is intentionally generated and/or used conductively coupled radio-frequency energy which is necessary for the internal functioning of the equipment itself.

•

Class A equipment is equipment suitable for use in all establishments other than domestic and those directly connected to a low-voltage power supply network which supplies buildings used for domestic purposes.

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. Datex, Ohmeda, DINAMAP, Trim Knob, Unity Network, CARESCAPE, EK-Pro, TruSignal, Entropy, GE Healthcare, GE Medical system, General Electric Company.

1

Introduction About this manual

1

1

4

Overview 1.1 1.2

1.3 1.4

2

System description 2.1 2.2 2.3 2.4 2.5 2.6

3

3.2 3.3

4.3 4.4

16

Main components... 16 3.1.1 Keypad... 16 3.1.2 Display... 16 3.1.3 CPU board... 18 3.1.4 Power board... 19 3.1.5 AC/DC unit... 21 3.1.6 Batteries... 21 Interfacing computer... 21 Connectors and signals... 22 3.3.1 External connectors... 22

Hemo-dynamic module introduction 4.1 4.2

13

Introduction... 13 Bus structure... 13 Distributed processing... 14 Module communication... 14 2.4.1 Serial communication... 14 Parameter modules... 15 Software loading... 15

Frame functional description 3.1

4

Symbols... 5 Safety information... 8 1.2.1 General... 8 1.2.2 Safety message signal words... 8 1.2.3 Safety precautions... 9 1.2.4 ESD precautionary procedures... 10 1.2.5 Disposal... 10 Service information... 10 1.3.1 Service requirements... 10 1.3.2 Equipment identification... 11 Product security... 11 1.4.1 Security features... 11 1.4.2 Security operations... 12 1.4.3 Product change management... 12 1.4.4 Communication... 12

25

Monitor software compatibility... 25 Main components... 25 4.2.1 Hemo-dynamic module... 25 4.2.2 Signals and isolation barrier... 26 4.2.3 Power supply section... 26 4.2.4 NIBP board... 27 4.2.5 ECG board in 5-lead measurement... 29 4.2.6 STP board... 31 Connectors and signals... 36 4.3.1 Front panel connectors... 36 Measurement principle... 38

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4.4.1 4.4.2 4.4.3 4.4.4 4.4.5 4.4.6

2

Hardware installation 1

Installation 1.1 1.2 1.3 1.4 1.5 1.6

1.7 1.8 1.9 1.10

3

NIBP... 38 ECG... 38 Pulse oximetry... 38 Temperature... 42 Invasive blood pressure... 42 Respiration... 42

1

Unpacking instructions... 2 Choosing location... 2 Mounting the monitor... 2 Connection to power... 2 Check configuration... 3 Connection to Network... 4 1.6.1 Pre-installation requirements... 6 1.6.2 To connect the network... 6 1.6.3 Network configuration... 6 Inserting and removing the E modules... 8 Monitor connections... 9 Visual indicators... 11 Installation checkout... 11

Maintenance 1

Instructions 1.1 1.2

2

Electrical Safety Tests 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8

3

3

Test setup... 3 Power Outlet Test... 3 Power cord and plug... 4 Ground (earth) integrity... 4 2.4.1 Ground Continuity Test... 4 2.4.2 Impedance of Protective Earth Connection... 5 Earth leakage current test... 5 Enclosure (Touch) leakage current test... 7 Patient leakage current tests - overview... 8 2.7.1 Patient (source) leakage current test... 9 2.7.2 Patient (sink) leakage current tests... 10 Test completion... 12

Installation checkout 3.1 3.2

1

Introduction... 1 Recommended tools... 2

13

Visual inspection... 13 Functional inspection... 13 3.2.1 Start-up... 13 3.2.2 Display... 14 3.2.3 Time and date... 14

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3.2.4 3.2.5 3.2.6 3.2.7

4

Maintenance and checkout 4.1 4.2

4.3

5

16

Visual inspection... 16 Functional inspection... 16 4.2.1 Start-up... 16 4.2.2 Display... 17 4.2.3 Keyboard(s)... 17 4.2.4 Time and date... 17 4.2.5 Hemo Module... 17 4.2.6 Loudspeaker... 21 4.2.7 Monitor software... 21 4.2.8 Watchdog circuitry... 21 4.2.9 Network... 21 4.2.10 Final cleaning... 22 Monitor battery maintenance... 22 4.3.1 Use recommendations... 22 4.3.2 Storage recommendations... 22 4.3.3 Test the battery charge... 22 4.3.4 Charge the battery... 22 4.3.5 Condition the battery... 23 4.3.6 Replace the battery... 23

Adjustments and calibrations 5.1 5.2 5.3

4

Parameters measurements... 14 Recorder... 14 MC or S/5 Network connection... 14 Conclusion... 15

24

NIBP calibrations... 24 Temperature calibration... 25 Invasive pressure calibration... 26

Troubleshooting 1

Introduction 1.1 1.2 1.3

2

Frame troubleshooting 2.1 2.2

3

3.5 3.6 3.7 3.8

4

Battery indicators... 6 NET section troubleshooting... 7

Hemo Troubleshooting 3.1 3.2 3.3 3.4

1

Visual inspection... 1 General troubleshooting... 2 Software troubleshooting chart... 3

9

NIBP troubleshooting flowchart... 9 ECG troubleshooting flowchart... 10 STP troubleshooting flowchart... 11 NIBP... 12 3.4.1 NIBP toubleshooting... 12 3.4.2 NIBP error code explanation... 14 ECG... 15 Impedance respiration... 16 Pulse oximetry (SpO2)... 17 Temperature... 18

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3.9

5

Service Menu 1

Introduction 1.1 1.2

2

3

3.2

3.3

4 5

5.2 5.3 5.4

5.5 5.6

20

Keyboard Log... 21

Parameters 5.1

7

Country Settings... 8 3.1.1 Languages... 8 Network... 10 3.2.1 Network Config (MC)... 11 3.2.2 TCP/IP... 11 3.2.3 HL7... 12 3.2.4 Dri Config (S/5)... 14 3.2.5 Dri Comm (in S/5)... 14 Power supply... 16 3.3.1 Power page... 16 3.3.2 WPM Battery... 17

Keyboard 4.1

3

SW Download... 3 Active Inactive SW... 4 NIBP SW Upgrade... 4 Country Settings... 5 License... 5 Enter/Exit Demo Mode... 6

Frame 3.1

1

Service Menu structure... 1 Service Menu... 2

SW Management 2.1 2.2 2.3 2.4 2.5 2.6

6

Invasive blood pressure... 18

22

Gas Unit... 23 5.1.1 General... 23 5.1.2 Gases... 24 ECG Module... 25 5.2.1 ECG Setup... 26 STP Module (for GE SpO2)... 27 5.3.1 Calibrations... 29 NIBP Module... 30 5.4.1 NIBP Calibration... 31 5.4.2 NIBP Safety Valve... 32 5.4.3 NIBP Pneumatics... 33 SpO2 (for Masimo/Nellcor SpO2)... 34 Entropy... 34

6

Set/Test

36

7

Service Log

37

Field replaceable unit

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1

Spare part 1.1 1.2 1.3 1.4 1.5 1.6 1.7

2

Disassembly 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10

7

1

Front cover... 1 Back cover unit... 2 Frame... 3 Extension rack... 3 Hemo box... 4 FRU parts list... 4 Other parts... 5

6

ESD precautions... 6 Reassembly precautions... 6 Required tools... 6 Before disassembly... 6 To separate the frame... 7 To disassemble the frame... 9 To disassemble the extended rack and the recorder... 15 Handling and storage of display component... 17 To replace the fuses... 17 To download the software... 17

E-miniC Module 1

Product overview 1.1 1.2 1.3

1.4

2

Maintenance and checkout 2.1 2.2 2.3

3

3.2

4

13

Sample flow rate adjustment... 13 3.1.1 Calibration setup... 13 3.1.2 Sample flow rate adjustment... 13 Gas calibration... 14 3.2.1 Calibration setup... 14 3.2.2 Procedure... 15

Troubleshooting 4.1

7

Replacement of planned maintenance parts... 7 2.1.1 Required parts... 7 2.1.2 Replacement procedure... 8 Visual inspections... 9 Functional checkout... 9 2.3.1 Test setup... 9 2.3.2 Procedure... 9 2.3.3 Test completion... 12

Calibration and adjustments 3.1

1

Introduction... 1 Measurement principle... 1 1.2.1 CO2 measurement... 1 Main components... 2 1.3.1 Gas sampling system... 3 1.3.2 MiniC sensor... 5 1.3.3 CPU board... 5 Connectors and signals... 6

16

Visual inspection... 16

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4.2 4.3

5

Disassembly and reassembly 5.1

5.2

6

19

Disassembly guidelines... 19 5.1.1 Serviceable parts... 19 5.1.2 Service limitations... 19 5.1.3 ESD precautions... 19 5.1.4 Before disassembly... 20 5.1.5 Tools needed... 20 Disassembly and reassembly procedure... 20 5.2.1 Replacing the pump unit... 21 5.2.2 Replacing the miniCO2 assembly... 21

Service parts 6.1 6.2

8

Troubleshooting checklist... 17 4.2.1 Gas sampling system troubleshooting... 17 4.2.2 MiniC sensor troubleshooting... 17 Troubleshooting charts... 18

22

Ordering parts... 22 Spare parts for E-miniC... 22

E-sCO, E-sCAiO and N-CAiO Modules 1

Product overview 1.1 1.2 1.3

2

Maintenance and checkout 2.1

2.2 2.3

3

3.2

13

Replacement of planned maintenance parts... 14 2.1.1 Required parts... 14 2.1.2 Planned Maintenance Kits... 14 2.1.3 Replacement procedures... 14 Visual inspections... 15 Functional check... 16 2.3.1 Test setup... 16 2.3.2 Procedure... 16 2.3.3 Test completion... 20

Calibration and adjustments 3.1

1

Introduction... 1 Measurement principle... 2 1.2.1 CO2, N2O, and agent measurement... 2 1.2.2 O2 measurement... 3 Main components... 4 1.3.1 Controls and connectors... 4 1.3.2 Gas sampling system... 4 1.3.3 MiniTPX measuring unit... 8 1.3.4 MiniOM Oxygen sensor... 9 1.3.5 CPU board... 10 1.3.6 MiniOM board... 11 1.3.7 Main Component Interactions... 11

21

Sample Flow Rate Adjustment... 21 3.1.1 Calibration setup... 21 3.1.2 Sample Flow Rate Adjustment... 21 Gas Calibration... 22 3.2.1 Calibration setup... 22

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3.2.2 Procedure... 23

4

Troubleshooting 4.1 4.2

4.3 4.4 4.5

5

Disassembly and reassembly 5.1

5.2

6

6.2

9

31

Disassembly guidelines... 31 5.1.1 Serviceable parts... 31 5.1.2 Service limitations... 31 5.1.3 ESD precautions... 31 5.1.4 Protection from dust... 32 5.1.5 Before disassembly... 32 5.1.6 Required tools... 33 Disassembly and reassembly procedure... 33 5.2.1 Disassembly workflow... 33 5.2.2 Detaching the Front Cover... 34 5.2.3 Detaching the Module Casing... 34 5.2.4 Replacement of Planned Maintenance Parts... 34 5.2.5 Replacement of CO2 Absorber... 35 5.2.6 Detaching the Latch... 35 5.2.7 Detaching the Front Chassis Unit... 36 5.2.8 Detaching the Main Flow Connector... 36 5.2.9 Detaching the Pump... 37 5.2.10 Detaching the OM holder... 38

Service parts 6.1

24

Visual inspection... 24 Troubleshooting checklist... 25 4.2.1 Gas sampling system troubleshooting... 25 4.2.2 MiniOM Measuring unit troubleshooting... 25 4.2.3 MiniTPX Measuring unit troubleshooting... 25 4.2.4 CPU board troubleshooting... 25 Service Interface... 26 Messages... 27 4.4.1 Gas measurement... 27 Troubleshooting charts... 30 4.5.1 Gas measurement... 30

39

Ordering parts... 39 6.1.1 Planned Maintenance Kits... 39 Spare parts for E-sCAiO, E-sCO, N-CAiO... 39 6.2.1 Front covers... 41

E-Entropy Module 1

Product overview 1.1 1.2

1.3

1

Introduction... 1 Measurement principle... 1 1.2.1 EntrEEG... 2 1.2.2 FEMG... 2 1.2.3 RE and SE... 2 1.2.4 Impedance measurement... 3 Main components... 3 1.3.1 Controls and connectors... 3 1.3.2 Entropy board... 4

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2

Maintenance and checkout 2.1 2.2 2.3

3

Troubleshooting 3.1 3.2

4

4.2

5

10

Disassembly guidelines... 10 4.1.1 ESD precautions... 10 4.1.2 Before disassembly... 10 4.1.3 Required tools... 11 Disassembling and reassembling procedure... 11 4.2.1 To replace the front cover... 11 4.2.2 To replace the Entropy board... 11 4.2.3 Reassembling the module... 11

Service parts 5.1 5.2

8

Visual inspection... 8 Troubleshooting chart... 9

Disassembly and reassembly 4.1

5

Visual inspections... 5 Electrical safety tests... 6 Functional check... 6 2.3.1 Test setup... 6 2.3.2 Entropy tests... 6 2.3.3 Test completion... 7

12

Ordering parts... 12 Spare parts for E-ENTROPY... 12

Appendix A:

ElectroMagnetic Compatibility

A-1

Appendix B:

Installation and checkout form, B40i/B20i

B-1

Appendix C:

Maintenance and checkout form, B40i/B20i

C-1

Appendix D:

Service check form, E-miniC

D-1

Appendix E:

Service check form, E-sCO, E-sCAiO and N-CAiO

E-1

Appendix F:

Service check form, E-Entropy

F-1

Appendix G:

Networking disclosure to facilitate network risk managment

G-1

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1 Introduction

About this manual

Indications for use: B40i This device is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The device is intended for use under the direct supervision of a licensed health care practitioner. The device is not intended for use during MRI. The device can be a stand-alone monitor or interfaced to other devices via a network. The device monitors and displays : ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring( including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardia l/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate), and Entropy.

Indications for use: B20i This device is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The device is intended for use under the direct supervision of a licensed health care practitioner. The device is not intended for use during MRI. The device can be a stand-alone monitor or interfaced to other devices via a network. The device monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardia l/Core/Surface temperature, and functional oxygen saturation (SpO2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion, and Entropy.

Intended audience This Technical reference manual is meant for service representatives and technical personnel who install, configure, maintain, administer, troubleshoot or repair B40i/B20i monitor running the software license VSP-C.

Notes to the reader As the monitor setup may vary, some functions described may not be available in the monitor you are using.

•

The order code for the manual is 2088566-001.

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•

Read the manual through and make sure that you understand the procedures described before the installation of the monitor. To avoid risks concerning safety or health, strictly observe the warning indications. If you need any assistance concerning the installation, please do not hesitate to contact your authorized distributor.

Installation without network are allowed by customer. The network installation and service are allowed by authorized service personnel only. GE Healthcare assumes no responsibility for the use or reliability of its software in equipment that is not furnished by GE.

Responsibility of the manufacturer GE Healthcare Finland Oy (GE) is responsible for the effects on safety, reliability and performance of the equipment only if: −

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

−

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

−

The equipment is used in accordance with the “User's Guide.”

−

The equipment is installed, maintained and serviced in accordance with this manual.

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

Related documentation −

Clinical aspects, basic methods of measurement and technical background: Patient Monitor B40i/B20i User’s Reference Manual

−

Options and selections of the software: Patient Monitor B40i/B20i Default Configuration Worksheet

−

Compatible supplies and accessories: Patient Monitor B40i/B20i Supplies and Accessories

−

Other devices closely related to the monitor:

• • •

iCentral and iCentral Client User's Reference Manual CIC Pro Clinical Information Center Operator's Manual CARESCAPE Central Station User’s Manual

Manual conventions To help you find and interpret information easily, the manual uses consistent text formats:



Sign the check form after performing the procedure.

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: −

Names of hardware keys on the keypad are written in bold typeface: NIBP

Start/Cancel.

−

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

−

Emphasized text is in italic typeface.

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−

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 statements provide application tips or other useful information.

Monitor naming conventions In this manual, the B40i Patient Monitor and B20i Patient Monitor are referred to as “the monitor” when a function or a feature applies to both. For describing monitor-specific issues, the monitors are referred to as B40i and B20i respectively.

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

• • • •

Single-width airway module: E-miniC CARESCAPE respiratory modules: E-sCO, E-sCAiO Airway Gas Option: N-CAiO E-modules: All modules with the prefix E-, In parameter chapters, E-modules refers to those modules that measure the parameter(s) in question.

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. If a particular selection is not available in your system, the selection is shown grayed.

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Overview The montior is a modular multiparameter patient monitor. The monitor is especially designed for monitoring in intensive care units. It can also be used during transportation within the hospital. The modular design makes the system flexible and easy to upgrade. NOTE: Your system may not include all these components. Consult your local representative for the available components.

3

1, 4 2

1.

The monitor frame

2.

E modules: The compatible acquisition modules

3.

Extension rack

4.

Software: VSP-C

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Overview

1.1 Symbols General warning. ISO 7010:2011 ed2.0. This symbol is identified by a yellow background, black triangular band, and a black symbol. On the hemo module this symbol indicates the following warning: -

Protection against cardiac defibrillator discharge is due in part to the accessories for pulse oximetry (SpO2), temperature (T) and invasive pressure (P) measurement.

General caution sign. ISO 7010:2011 ed2.0. This symbol is identified by a white background, black triangular band, and a black symbol. Follow operating instructions

Refer to instruction manual/booklet

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. Isolated (floating) 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, excluding direct cardiac application. Type CF (IEC 60601-1) 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) defibrillator-proof protection against electric shock. Isolated (floating) applied part suitable for intentional external and internal application to the patient including direct cardiac application. In the front panel: battery

Equipotentiality. Monitor can be connected to potential equalization conductor. Alternating current

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Audio pause.

Home. Return to the normal screen. ON/OFF. Fuse. Replace the fuse only with one of the same type and rating

Gas inlet.

Gas outlet. IP21

Degree of ingress protection. Serial number Date of manufacture. This symbol indicates the date of manufacture of this device. The four digits identify the year, the middle two digits identify the month, the last two digits identify the date. Manufacturer. This symbol indicates the name and the address of the manufacturer. European Union Declaration of Conformity.

Rx Only U.S.

Prescriptive Device. USA only. For use by or on the order of a Physician or persons licensed by state law. Fragile. Handle with care.

Keep dry. Protect from rain.

This way up.

Storage temperature

Humidity limitations.

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Overview

Atmospheric pressure limitations.

Recycled materials or may be recycled. 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. The separate collection symbol is affixed to a battery, or its packaging, to advise you that the battery must be recycled or disposed of in accordance with local or country laws. To minimize potential effects on the environment and human health, it is important that all marked batteries that you remove from the product are properly recycled or disposed. For information on how the battery may be safely removed from the device, please consult the service manual or equipment instructions. Information on the potential effects on the environment and human health of the substances used in batteries is available at this url: http://www.gehealthcare.com/euen/weee-recycling/index.html

A B

B

Battery operation and remaining capacity. The height of the green bar indicates the charging level. Battery (A) charging (white bar)

Battery (A) failure

B No battery backup

Battery (A) missing

Submenu. Selecting a menu item with this symbol opens a new menu. The monitor is connected to Network. A blinking heart next to the heart rate or pulse rate value indicates the beats detected. A lung next to the respiration rate value indicates that respiration rate is calculated from the impedance respiration measurement.

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Alarm off indicator - Displays in the digit field and in the Alarms Setup menu when physiological alarms for this parameter are turned off. Audio alarms off indicator - Displays in the upper left corner of the alarm area when physiological audible alarms are turned off. Audio alarms paused indicator - Indicates all audio alarms are paused and the amount of time remaining for the alarm pause period displays as a countdown timer. Displays in the upper left corner of the screen.

C

US 3ZG9

B40i Only. Underwriters Laboratories product certification mark. Medical Equipment with respect to electrical shock, fire and mechanical hazards only in accordance with ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012; CSA CAN/CSA-C22.2 NO. 60601-1:14; IEC 60601-2-26; IEC 60601-2-27; IEC 80601-2-30; IEC 60601-2-34; IEC 60601-2-49; ISO 80601-2-55; ISO80601-2-56; ISO80601-2-61

1.2 Safety information 1.2.1 General This device is intended for use under the direct supervision of a licensed health care practitioner. Contact GE for information before connecting any devices to the equipment that are not recommended in this manual. Parts and accessories used must meet the requirements of the applicable IEC 60601 series safety standards, and/or the system configuration must meet the requirements of the IEC 60601-1 medical electrical systems standard. Periodically, and whenever the integrity of the device is in doubt, test all functions. The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include:

• •

use of the accessory in the PATIENT VICINITY; and evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 60601-1.

If the installation of the equipment, in the USA, will use 240V rather than 120V, the source must be a center-tapped, 240V, single-phase circuit.

1.2.2 Safety message signal words Safety message signal words designate the severity of a potential hazard. DANGER: Indicates a hazardous situation that, if not avoided, will result in death orserious injury. No danger messages apply to this system. WARNING: Indicates a hazardous situation that, if not avoided, could result in death orserious injury. CAUTION: Indicates a hazardous situation that, if not avoided, could result in minor or moderate injury.

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