Solar 8000M and i Patient Monitor Operators Manual Version 5.0

NOTE The information in this manual only applies to Solar™ 8000M/i Patient Monitor software version 5.0. Due to continuing product innovation, specifications in this manual are subject to change without notice. NOTE For technical documentation purposes, the abbreviation GE is used for the legal entity name, GE Medical Systems Information Technologies. NOTE The Patient Data Module is described in promotional materials as CARESCAPE Patient Data Module. Listed below are GE trademarks used in this document. All other trademarks contained herein are the property of their respective owners. MUSE, QS, SOLAR, ST GUARD, TRAM, TRIM KNOB, and UNITY NETWORK are trademarks of GE Medical Systems Information Technologies registered in the United States Patent and Trademark Office. 12SL, 12RL, ApexPro, AWARE, CARESCAPE, and EK-Pro are trademarks of GE Medical Systems Information Technologies.

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Contents 1

The Basics... 1-1 About This Manual... 1-2 Manual Purpose... 1-2 Intended Audience... 1-2 Revision History... 1-2 Ordering Manuals... 1-2 Manual Conventions... 1-2 Product References... 1-2 Definitions... 1-3 Text Styles... 1-3 Illustrations and Names... 1-3 Software Packages... 1-4 Menus... 1-5 Main Display... 1-5 More Menus... 1-6 Popup Menus... 1-7 Subordinate Menus... 1-8 Direct Action Menu Options... 1-9 Windows... 1-9 Parameter Windows... 1-10 Maximum Display of Parameter Windows and Waveforms... 1-10 Information Windows... 1-11 Common Operations... 1-12 Using the Trim Knob Control... 1-12 Using the Touchscreen Display... 1-12 Entering Alphanumeric Characters... 1-14 Setting Alarm Limits... 1-16 Selecting Options from Scroll Lists... 1-17 Language-Specific Information... 1-18 Chinese and Japanese Language Information... 1-18 French Language Information... 1-19 Hungarian, Polish and Russian Language Information... 1-19

2

Equipment Overview... 2-1 Components... 2-2 Solar 8000M/i Patient Monitoring System... 2-2 Patient Data Module... 2-5 TRAM Modules... 2-8 Single-Parameter Modules... 2-11 Tram-rac Housing... 2-11

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Optional Clinical Information Center... 2-15 Optional Writers and Printers... 2-16 Optional Remote Display... 2-16 Optional Connectivity Device... 2-16 Optional iPanel Computer... 2-16 Controls... 2-16 Keypad and Remote Control... 2-16 Putting the Monitor Into Operation... 2-18 Monitor Installation and Connection... 2-18 Turning Power On... 2-19 Performance Check... 2-20 Service PDM Message... 2-20

3

Safety... 3-1 For Your Safety... 3-2 Intended Use... 3-2 Intended Use of 12RL Interpolated 12-lead... 3-2 Terminology... 3-3 Monitor Safety... 3-3 Classification... 3-13 Underwriters Laboratories, Inc... 3-15 Equipment Symbols... 3-15

4

Maintenance... 4-1 Biocompatibility... 4-2 Inspection... 4-2 General Cleaning... 4-2 Cleaning the Touchscreen... 4-3 Cleaning the Patient Data Module or TRAM Module... 4-4 Cleaning Applied Parts... 4-4 Cleaning, Disinfecting and Storing GE ECG Cables and Leadwires... 4-4 Cables and Leadwires other than GE... 4-6 Other... 4-7 Internal Lithium Battery... 4-7 Technical Maintenance... 4-7

5

Monitor Setup... 5-1 Monitor Setup Menu... 5-2 Monitor Setup Menu Overview... 5-2

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Waveforms On/Off... 5-2 Display... 5-4 Color... 5-5 Parameters On/Off... 5-7 Graph Setup... 5-7 Monitor Defaults... 5-11 Monitor Defaults Password... 5-17 Print CRG Plus... 5-18 Touchscreen Volume... 5-18 Learn the Monitor... 5-18 Software Revision... 5-19 Service Mode... 5-20

6

Admit/View A Patient... 6-1 About Admitting... 6-2 Introduction... 6-2 Auto Admit... 6-2 Monitor Applications... 6-3 Combination Monitoring... 6-4 Admit Menus... 6-8 Admit Menu Overview... 6-8 Standard Admit Menu... 6-8 Rover Admit Menu... 6-9 Combo Admit Menu... 6-9 Rover Combo Admit Menu... 6-10 Admit Menu Options... 6-11 Change Admit Info... 6-11 Request Admit Information... 6-13 ECG Source... 6-14 Graph Location... 6-14 Set Unit Name... 6-14 Set Bed Number... 6-14 Units of Measure... 6-15 Options for Admitting a Patient... 6-15 About Discharging... 6-16 Overview... 6-16 Discharge Patient - Standard and Rover Applications... 6-16 Discharge Patient - Combo and Rover Combo Applications... 6-17 New Case... 6-17 Viewing Other Patients... 6-18 Overview... 6-18 Automatic View On Alarm Feature... 6-19 Viewed Patient Display... 6-22 Monitor Setup for Viewing Other Patients... 6-23 Default Settings... 6-23 View On Alarm Options Menu Settings... 6-26

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View Other Patients Menu... 6-26 Overview... 6-26 View Alarm... 6-27 View On Alarm Options... 6-28 Select a Bed to View... 6-33 Turn the View Off... 6-33 Select Another Care Unit... 6-33 Graph Viewed Bed... 6-33 Viewed Patient Data... 6-34 Full Patient View... 6-34

7

Printing... 7-1 Writers and Printers... 7-2 PRN 50 and PRN 50-M Digital Writers... 7-2 Laser Printer... 7-4 Graphing... 7-5 Manual Graphs... 7-5 Alarm Graphs... 7-5 Invasive BP Only... 7-6 Pressure Scales... 7-6 Graphing Messages... 7-6 Graph Header... 7-7

8

Alarm Control... 8-1 Smart Alarms... 8-2 Alarm Structure... 8-2 Patient Status Alarms... 8-2 System Status Alarms... 8-3 On-screen Alarm Help... 8-4 Controlling Audio Alarms... 8-4 Silencing Alarms... 8-4 Pausing Alarms... 8-4 Alarm Pause Breakthrough... 8-5 Remote Silencing... 8-6 Turning Alarm Volume Off Permanently... 8-6 Alarm Window... 8-6 Overview... 8-6 Clear Alarms... 8-7 Alarm Histories... 8-7 Alarm Control Menu... 8-7 Overview... 8-7 All Limits... 8-8 Arrhythmia Alarm Level... 8-9 Parameter Alarm Level... 8-9

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Alarm Volume... 8-9 Alarm Help... 8-10 Display Off/Alarm Pause... 8-11 Clear Alarms... 8-12 Alarm History... 8-12 CRG Trends... 8-12 Alarm Pause... 8-12

9

CRG Plus Display... 9-1 Parameters Displayed... 9-2 Overview... 9-2 CRG Plus Full Display... 9-2 CRG Plus Individual Display... 9-3 Turning on the CRG Plus Display... 9-3 Selecting Parameters for the CRG Plus Display... 9-4 Printing CRG Plus Parameters... 9-4 Print CRG Plus... 9-4 CRG Plus Printing Options... 9-4 CRG Trends... 9-6 CRG Trends Display... 9-6 CRG Trends Event Directory... 9-7 CRG Trends Menu Options... 9-8 Document CRG Events... 9-10 Troubleshooting... 9-11

10

Patient Data... 10-1 Patient Data Menu... 10-2 Patient Data Menu Overview... 10-2 Alarm History... 10-2 Vital Signs... 10-5 Graphic Trends... 10-7 Cardiac Calcs... 10-10 Pulmonary Calcs... 10-12 Dose Calcs... 10-17 CRG Trends... 10-22

11

ECG... 11-1 Introduction... 11-2 PDM No ECG Alarm... 11-2 TRAM “NO ECG” Alarm... 11-3 Checklist... 11-4

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ECG Monitoring Features... 11-4 ECG Display... 11-4 ECG Menu... 11-5 Getting to the ECG Menu... 11-5 Display Lead... 11-6 ECG Size... 11-8 Detect Pace... 11-9 ECG Limits... 11-13 View All ECG... 11-14 Clear V2-V6 Fail... 11-15 Update Lead Set... 11-15 Arrhythmia... 11-15 Relearn... 11-18 ST Analysis... 11-19 ST Analysis Menu... 11-21 ECG Filter... 11-26 12 Lead ECG Analysis... 11-27 Using 12RL Interpolated 12-lead Analysis... 11-31 Lead Analysis... 11-36 More ECG... 11-37 ECG Rate Averaging... 11-41 Troubleshooting... 11-41 ECG Troubleshooting... 11-41 Pacemaker Troubleshooting... 11-43

12

Pressures... 12-1 Introduction... 12-2 Safety... 12-3 Invasive Pressure Y-Adapter Cable... 12-4 Zero Reference... 12-5 Checklist... 12-6 Pressure Monitoring... 12-6 Pressure Information... 12-6 Getting to the Pressure Menu... 12-7 Pressure Menu Options... 12-8 Scales... 12-8 Full Scales... 12-8 Cursor... 12-8 Clear Cursor... 12-9 Limits... 12-9 Change Name... 12-9 Zero... 12-10 BP Filter... 12-10

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Calibrate Transducer... 12-10 Speed... 12-11 Special Features... 12-11 IABP... 12-11 Using the IABP Feature... 12-12 Smart BP... 12-13 Pulse Rate... 12-13 Disconnect Alarm... 12-13 PA Wedge... 12-14 Overview... 12-14 PA Wedge Menu Option... 12-14 PA Insert Wedge Menu Option... 12-15 Troubleshooting... 12-21 “Pressure” Message Appearing When Zeroing Invasive Pressure Lines... 12-21

13

NBP... 13-1 Introduction... 13-2 NBP Connectors... 13-2 Safety... 13-3 NBP Technologies... 13-4 Checklist... 13-5 NBP Monitoring Features... 13-6 NBP Information... 13-6 Getting to the NBP Menu... 13-8 NBP Menu Options... 13-9 NBP Auto... 13-9 NBP Stat... 13-10 Review NBPs... 13-11 NBP Limits... 13-11 Cuff Size... 13-11 Clear NBP Reading... 13-11 Initial Inflation Pressure... 13-11 Custom Defaults... 13-12 Auto NBP Cancellation Notification... 13-12 Extended NBP Alarm Silence... 13-12 Troubleshooting... 13-13 NBP Status Messages... 13-13

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14

SpO2... 14-1 Introduction... 14-2 Safety... 14-4 Safety Messages... 14-4 Measurements... 14-6 Neonates and Infants... 14-6 Checklist... 14-7 Masimo SET Module... 14-7 No Implied License... 14-7 Masimo SET Module PWR Indicator Light... 14-7 SpO2 Monitoring Features... 14-8 SpO2 Information... 14-8 Getting to the SpO2 Menu... 14-9 SpO2 Menu Options... 14-10 Size... 14-10 Rate... 14-11 Rate Volume... 14-11 SpO2 Limits... 14-11 Sat-Seconds... 14-12 Persistent... 14-12 Response... 14-12 Speed... 14-13 Sensitivity... 14-13 Averaging... 14-13 SpO2 System Alarms... 14-13 Probe Off Patient Condition... 14-13 Connect SpO2 Probe Condition... 14-14 Pulse Search Condition... 14-14 Troubleshooting... 14-14 SpO2 Messages... 14-14

15

Cardiac Output... 15-1 Introduction... 15-2 Cardiac Output Overview... 15-2 Influencing Factors... 15-3 Suggested Cardiac Output Procedure... 15-3 Checklist... 15-5 Cardiac Output Monitoring Features... 15-5 Cardiac Output Information... 15-5 Cardiac Output Trials... 15-6

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Getting to the Cardiac Output Menu... 15-7 Cardiac Output Menu Options... 15-8 Delete CO Trials... 15-8 Cardiac Calcs... 15-9 Cardiac Output Now... 15-11 BT Limits... 15-11 Print CO Curve... 15-11 Auto Mode... 15-12 Use: PAW (PAD, LA)... 15-12 Catheter... 15-12 Injectate Temperature... 15-13 Size... 15-13 Injectate Volume... 15-13 Computation Constant... 15-14 Cardiac Output Help... 15-14 Troubleshooting... 15-14 Procedural Prompts and Messages... 15-14 Error Messages... 15-15

16

Respiration... 16-1 Introduction... 16-2 Respiration Overview... 16-2 No Breath and Apnea Events... 16-2 General Information... 16-3 Checklist... 16-5 Respiration Monitoring Features... 16-5 Respiration Information... 16-5 Getting to the Respiration Menu... 16-5 Respiration Menu Options... 16-6 Lead... 16-6 Relearn Respiration... 16-7 Sensitivity... 16-7 Respiration Limits... 16-7 Auto Size... 16-8 Manual Size... 16-8 Cardiac Artifact Alarm... 16-8 Speed... 16-9 Troubleshooting... 16-9 Messages... 16-9

17

Temperature... 17-1 Introduction... 17-2 Checklist... 17-2

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Temperature Monitoring Features... 17-3 Temperature Information... 17-3 Getting to the Temperature Menu... 17-4 Temperature Menu Options... 17-4 T1... 17-4 T2... 17-5 Units... 17-5 Temperature Limits... 17-5 Select Default Temperature Site Labels... 17-5 Troubleshooting... 17-5 Messages... 17-5

18

SvO2... 18-1 Introduction... 18-2 Checklist... 18-2 SvO2 Monitoring Features... 18-3 SvO2 Information... 18-3 Getting to the SvO2 Menu... 18-3 SvO2 Menu Options... 18-4 SvO2 Limits... 18-4 SvO2 Help... 18-4 Preinsertion Calibration... 18-4 Light Intensity Calibration... 18-5 Calibrate to Venous Blood Gas... 18-5 SvO2 Cal History... 18-5 Calibration... 18-5 Calibration Overview... 18-5 Preinsertion Calibration... 18-5 Light Intensity Calibration... 18-6 Calibrate to Venous Blood Gas... 18-6 SvO2 Cal History... 18-8 Troubleshooting... 18-9 PREINSERT CAL FAIL Message... 18-9 LOW LIGHT or NO LIGHT Message... 18-9 SERVICE MODULE Message... 18-10 X Displayed in SvO2 Parameter Window... 18-10

19

CO2... 19-1 Introduction... 19-2 Safety... 19-2

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CO2 Monitoring Features... 19-4 CO2 Information... 19-4 Capnostat Modules... 19-5 General Information... 19-5 CO2 Menu Options (Capnostat Modules)... 19-7 Getting to the CO2 Menu... 19-7 Pump... 19-8 Units... 19-8 CO2 Scale... 19-8 CO2 Limits... 19-8 N2O Compensation... 19-9 O2 Compensation... 19-9 CO2 Averaging... 19-9 Cal Sensor to Zero Cell... 19-9 Calibrate Adapter... 19-10 Speed... 19-10 Zero the Capnostat Sensor... 19-10 Calibrate the Capnostat Adapter... 19-11 Capnostat Sensor and Adapter Cleaning... 19-11 Cleaning the Capnostat Sensor... 19-11 Cleaning the Reusable Capnostat Adapters... 19-11 Capnostat Sensor Troubleshooting... 19-12 Messages... 19-12 Sidestream Modules... 19-14 Pump Control... 19-14 CapnoFlex LF CO2 Module... 19-15 CapnoFlex LF CO2 Module Troubleshooting... 19-16 CO2 Menu Options (Non-Capnostat Modules)... 19-16 Getting to the CO2 Menu... 19-16 Units... 19-17 CO2 Scale... 19-17 CO2 Limits... 19-17 N2O Compensation... 19-17 Speed... 19-18

20

Interfaces... 20-1 Introduction... 20-2 Safety... 20-5 Interconnection... 20-6

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Serial Port Indicator Lights... 20-7 Displayed Data... 20-8 Displayed Data Overview... 20-8 Parameters... 20-9 Parameter Windows and Menus... 20-9 Software Compatibility... 20-14 Device-Specific Information... 20-14 Dräger Fabius GS Ventilators... 20-14 Dräger Ventilators... 20-14 Siemens Servo-i Ventilators... 20-15 Siemens Servo 300 Ventilators... 20-15 Siemens Servo 900C/D/E Ventilators... 20-15 Alaris Medical Systems 7130 and 7230 Infusion Pumps... 20-15 Linde MicroGas 7650 Transcutaneous Monitors... 20-16 Baxter Edwards Critical-Care Vigilance Monitors... 20-16

A

Appendix A - Adult-ICU Mode Defaults... A-1 Adult-ICU Mode Defaults... A-2

B

Appendix B - Neonatal-ICU Mode Defaults... B-1 Neonatal-ICU Mode Defaults... B-2

C

Appendix C- Operating Room Mode Defaults . . . C-1 Operating Room Mode Defaults... C-2

D

Appendix D - Monitor Defaults Worksheet... D-1 Monitor Defaults Worksheet... D-2

E

Appendix E - Analog Output... E-1 Analog Output... E-2 Overview... E-2 Acquisition Modules... E-2 Tram-rac Housing... E-3

F

Appendix F - Supplies Information... F-1 Appendix F - Supplies Information... F-2

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G

Appendix G - Software Packages... G-1 Software Packages... G-2

H

Appendix H - Technical Specifications... H-1 Solar 8000M/i Patient Monitor... H-2 Patient Data Module... H-3 TRAM Module... H-8 Single Parameter Modules... H-10 Solar 8000M/i Display... H-11 Solar 8000M/i Display Overview... H-11 Purchaser’s Responsibility... H-11 Medical-Grade Displays... H-12 Non-Medical Grade Displays... H-12 Required Specifications for Non-Medical Grade CRT Displays... H-12 Recommended Specifications for Non-Medical Grade CRT Displays . . . H-13 Required Specifications for Non-Medical Grade Digital Flat Panel Displays... H-14 Recommended Specifications for Computer-Grade Digital Flat Panel Displays... H-14

I

Appendix I - PDM Battery...I-1 Battery Overview... I-2 Battery Status... I-2 Battery Capacity Gauges... I-3 Battery Maintenance... I-5 How to Charge the Battery... I-5 How to Condition the Battery... I-5 How to Wake Up the Battery... I-6 The Cadex SMart Two+ Charger... I-7 Battery Charger LED Indicators...I-7 Replacing the Battery... I-7 Safety...I-7 Replace the Battery...I-8 Recycle the Battery... I-9 Troubleshooting... I-9 ERROR is Displayed in the Battery Capacity Gauge Icon...I-9 Battery LEDs will not Illuminate...I-10

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J

Appendix J - Abbreviations and Symbols... J-1 Abbreviations and Symbols... J-2

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CE Marking Information Compliance The Solar 8000i patient monitor bears CE mark CE-0459 indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfills the essential requirements of Annex I of this directive. The product is in radio-interference protection class A in accordance with EN 55011. The country of manufacture can be found on the equipment labeling. The product complies with the requirements of standard EN 60601-1-2 “Electromagnetic Compatibility - Medical Electrical Equipment”.

Exceptions NOTE These exceptions apply only to the Solar 8000M system. The Solar 8000M system EMC: Immunity Performance - IEC 60601-1-2 Medical Electrical Equipment, Part 1: General Requirements for Safety, 2. Collateral Standard: Electromagnetic compatibility-Requirements and tests. Section 36.202.a-Radiated electromagnetic fields states: For Patient Coupled Equipment and/or systems applicable IMMUNITY levels are under consideration. The 3 volts per meter IMMUNITY level may be inappropriate because the physiological signals measured can be substantially below those induced by a field strength of 3 volts per meter. The TRAM module respiration parameter numeric and waveform data may be affected at levels of 3 volts per meter or greater over the frequency range of 115 to 125 MHz. Noise may be induced on the CO2 waveform from the CO2 Capnostat modules when the system is used in the presence of an electromagnetic field strength of 3 volts per meter or greater. Measurement accuracy is maintained at a field strength of 3 volts per meter or less. Users should be aware of known RF sources, such as radio or TV stations and handheld or mobile two-way radios, and consider them when installing a medical device or system. Be aware that adding accessories or components, or modifying the medical device or system may degrade the immunity performance. Consult with qualified personnel regarding changes to the system configuration.

General Information „

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This manual is an integral part of the product and describes its intended use. It should always be kept close to the equipment. Observance of the manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety.

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CE Marking Information

CE-2

„

The symbol

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Information which refers only to certain versions of the product is accompanied by the model number(s) of the product(s) concerned. The model number is given on the nameplate of the product.

„

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

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

means ATTENTION: Consult accompanying documents.

‹

assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE;

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the electrical installation of the relevant room complies with the requirements of the appropriate regulations; and,

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the device is used in accordance with the instructions for use.

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All publications conform with the product specifications and applicable IEC publications on safety and essential performance of electromedical equipment as well as with applicable UL and CSA requirements and AHA recommendations valid at the time of printing.

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

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The Basics

About This Manual Manual Purpose This manual contains the instructions necessary to operate the Solar 8000i or Solar 8000M patient monitor safely and in accordance with its function and intended use. NOTE This manual contains instructions to operate both the Solar 8000i patient monitor and the Solar 8000M patient monitor. Operation of the two monitors is identical unless noted.

Intended Audience This manual is intended for clinical professionals. Clinical professionals are expected to have a working knowledge of medical procedures, practices, and terminology, as required for monitoring of critically ill patients.

Revision History Each page of the document has the document part number and revision letter at the bottom of the page. The revision letter changes whenever the document is updated.

Revision A

Comments Initial release of this document.

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.

Manual Conventions This section describes terminology, standards, and other conventions that are used throughout this manual.

Product References In this manual:

1-2

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The Solar 8000i and Solar 8000M patient monitors are referred to as the monitor. or the Solar 8000M/i monitor.

„

Collectively, the Patient Data Module (also referred to as PDM) and the TRAM module are referred to as acquisition modules.

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The Clinical Information Center is referred to as the central station.

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The Basics

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The Solar SpO2 module with Masimo SET is referred to as the Masimo module.

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The PRN 50 and PRN 50-M digital writers are referred to as the writers.

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The laser printer is referred to as the printer.

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Collectively, the laser printer and the PRN 50 digital writer are referred to as printers.

Definitions The following terms are used in this manual to describe various monitor features and functions. Button - A labeled key located on the keypad or remote control. Press to initiate a process, open a menu, or enter a number. Menu - Text which appears at the bottom of the display. A menu is composed of a set of menu options. Menu option - A choice found in a menu. A menu option is enclosed in a rectangle. Screen text - Any text that appears on the monitor display. In this manual, screen text is shown in bold italics (for example, ECG, SAVING, etc.).

Text Styles This manual uses the following text styles to identify various items.

Style

Definition

Bold

Indicates hardware terms, such as buttons, labels or connectors.

Bold and italicized

Indicates software items, such as menus, menu options or screen text.

Italics

Emphasizes a word.

>

Indicates menu options or control settings to select consecutively.

Illustrations and Names All illustrations in this manual are provided as examples only. They may not necessarily reflect your monitoring setup or data displayed on your monitor. In this manual, all names appearing in examples and illustrations are fictitious. The use of any real person’s name is purely coincidental.

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