Solar 9500 Operators Manual Version 3 Rev C

127(Information in this manual only applies to Solar 9500 Information Monitor software version 3. It does not apply to earlier software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice.

Listed below are GE Medical Systems Information Technologies trademarks used in this document. All other trademarks contained herein are the property of their respective owners. SOLAR, TRAM, TRAM-RAC, and UNITY NETWORK ID are trademarks of GE Medical Systems Information Technologies registered in the United States Patent and Trademark Office. © GE Medical Systems Information Technologies, 2002, 2003. All rights reserved.

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CE Marking Information

CE Marking Information Compliance The Solar 9500 Information 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”. The safety and effectiveness of this device has been verified against previously distributed devices. Although all standards applicable to presently marketed devices may not be appropriate for prior devices (i.e. electromagnetic compatibility standards), this device will not impair the safe and effective use of those previously distributed devices. See user’s information.

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CE Marking Information

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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The symbol documents.

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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.

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

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

means ATTENTION: Consult accompanying

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

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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 Solar 9500 Information Monitor 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 GE Medical Systems Information Technologies quality management system complies with the international standards DIN EN ISO 9001 and EN 46001, and the Council Directive on Medical Devices 93/42/EEC Annex II.

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Contents

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The Basics... 1-1 About This Manual... 1-3 Manual Purpose... 1-3 Intended Audience... 1-3 Conventions... 1-3 Revision History... 1-4 Equipment Description... 1-5 Basic System Components... 1-5 Solar 9500 Processing Unit Connectors... 1-6 Acquisition Modules... 1-8 Software Description... 1-12 Monitor Controls... 1-12 Monitor Display... 1-13 Lower Control Buttons... 1-13 Direct Action Buttons... 1-15 Waveform Windows... 1-16 Control Windows and Procedure Windows... 1-16 Parameter Windows... 1-17 Preparing the Equipment for Use... 1-18 Using Two Tram-rac Housings... 1-18 Installing or Removing a Module... 1-19 Turning Power On... 1-20 Configuring Waveform Windows... 1-21 Setting the Color of Waveforms and Parameter Numerics... 1-23 Moving Waveforms... 1-24 Sizing Waveforms... 1-24 Language-Specific Information... 1-25 French Language Information... 1-25 Hungarian, Polish and Russian Language Information... 1-25 Japanese Language Information... 1-25

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Safety... 2-1 For Your Safety... 2-3 Intended Use... 2-3 Terminology... 2-3 Monitor Safety... 2-4 Reference Literature... 2-11 Classifications... 2-12 Underwriters Laboratories, Inc... 2-12 Equipment Symbols... 2-13

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Setups Menu... 3-1 Introduction... 3-3 Cancel... 3-4 Switch Layout... 3-5 Switching a Layout... 3-5 Show/Hide Factory Defaults... 3-5 Edit Remote Display... 3-6 Editing Controls... 3-6 Waveform Window Controls... 3-7 Alarm Setup... 3-8 Alarm Graph Setup... 3-9 Parameters On/Off... 3-10 Unmonitored Parameters... 3-11 Select Printers... 3-12 Configuration/Service... 3-13 Touchscreen Controls... 3-13 Parameter Defaults... 3-15 System Shutdown... 3-17 Software Revision... 3-17 Service Mode... 3-17

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Alarms... 4-1 Alarm Structure... 4-3 Patient Status Alarms... 4-3 System Status Alarms... 4-4 Silencing Alarms... 4-4 Patient Status Alarms... 4-5 Alarm Setup Window... 4-5 Alarms Displayed in Parameter Windows... 4-9

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Printing... 5-1 General Information... 5-3 Configuring Printers... 5-3 Selecting a Printer... 5-4 Print Types... 5-4 Remote Graphing Information... 5-5 Manual Graphing... 5-6 Manual Graph Setup... 5-7 Print Setup Window... 5-8 Saving a Print Configuration... 5-9 Alarm Graphing... 5-10 Automatic Graphing... 5-10 Alarm Graph Setup... 5-10 PRN 50-M Digital Writer... 5-13 Changing the PRN 50-M Digital Writer Paper... 5-14 Troubleshooting... 5-15

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Patient Data... 6-1 Introduction... 6-3 Trends... 6-4 Storage of Trend Data... 6-4 Accessing the Trends Window... 6-4 Display Format... 6-4 Graphic Trends... 6-5 Graphic Trends Controls... 6-6 Tabular Trends Display... 6-9 Tabular Trends Controls... 6-10 Managing Trend Data... 6-13

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Cardiac Calcs... 6-14 Display Format... 6-15 Controls... 6-15 Cardiac Calcs Table... 6-15 Alarm History... 6-16 Arrhythmia Review... 6-17 Arrhythmia Data Controls... 6-17 ST Analysis... 6-19 Patient Info... 6-20 Entering Data... 6-21 Tram Patient Data... 6-23 View Other Patient... 6-24 Browser... 6-25 Browser Login... 6-26 Internet Explorer Interface... 6-26 Icon Browser Interface... 6-27 Basic Browser Operations... 6-28

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View Other Patients... 7-1 Viewing Other Patients... 7-3 Guidelines... 7-3 Viewed Patient Window... 7-4 Controls... 7-5 Configuring Waveforms... 7-7 Freeze Waveforms... 7-7 Turn the View Off... 7-8

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Maintenance... 8-1 Biocompatibility... 8-3 Inspection... 8-4 General Cleaning... 8-5 Cleaning the Touchscreen... 8-6 Cleaning Applied Parts... 8-7

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Cables and Leadwires... 8-7 CO2 Mainstream Sensor... 8-7 CO2 Mainstream Airway Adapter... 8-7 Other... 8-7 Turning Power Off... 8-8 Using the Menu Command... 8-8 Using the Power Switch... 8-8 Technical Maintenance... 8-9 Technical Specifications... 8-9

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ECG Monitoring... 9-1 Introduction... 9-3 Checklist... 9-3 Skin Preparation... 9-4 Electrode Placement... 9-5 5-Leadwire Electrode Placement... 9-5 Alternate 3-Leadwire Electrode Configuration... 9-6 10-Leadwire Electrode Placement... 9-8 Electrode Placement for Pacemaker Patients... 9-9 Maintaining Quality ECG Signal... 9-10 ECG Monitoring Information... 9-11 Pace Detection... 9-12 Arrhythmia... 9-15 Single vs. Multi-Lead Analysis... 9-19 Relearn ECG... 9-20 Smart-Lead Fail... 9-20 ECG Parameter Window... 9-21 ECG Waveform Display... 9-21 ECG Controls Window... 9-23 ST Analysis... 9-26 ST Numerics... 9-26 ST Waveform Information... 9-26 ST Analysis Window... 9-27 ST Controls Window... 9-29 12-Lead ECG Analysis... 9-31 12-lead ECG Analysis Window... 9-32 Troubleshooting... 9-37

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Invasive Pressure Monitoring... 10-1 Introduction... 10-3 Assigned BP Names... 10-4 Site Names... 10-4 BP Connector Names... 10-4 Zero Reference... 10-5 Checklist... 10-6 Pressure Monitoring... 10-7 Smart BP... 10-7 IABP... 10-8 Triggering... 10-8 Using the IABP Feature... 10-9 Turning IABP Program On... 10-9 Displayed Values... 10-10 Invasive Pressure Parameter Window Displays... 10-13 Invasive Pressure Waveform Displays... 10-14 Configuration... 10-14 Invasive Pressures Controls Window... 10-15 General Information... 10-15 PA Wedge... 10-18 PA Parameter Window Display... 10-18 PA Wedge Procedure Window... 10-19 PA Wedge Procedure... 10-21 Using the PA Wedge Value... 10-22 Catheter Insertion... 10-23 Catheter Insertion Window... 10-23 General Troubleshooting... 10-25 Wedge Troubleshooting... 10-26

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NBP Monitoring... 11-1 Introduction... 11-3 Checklist... 11-4 Patient Preparation... 11-6 Cuff Selection... 11-6 Cuff Placement... 11-6 NBP Parameter Data... 11-7 NBP Parameter Window... 11-7 NBP Controls Window... 11-8 Accessing the NBP Controls Window... 11-8 NBP Controls... 11-8 Troubleshooting... 11-11 NBP Status Messages... 11-11

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SpO2 Monitoring... 12-1 Introduction... 12-3 Module and Probe Compatibility... 12-4 Checklist... 12-4 Safety... 12-5 Measurements... 12-6 Neonates and Infants... 12-7 Patient Preparation... 12-8 Signal and Data Validity... 12-9 Signal Strength Indicator... 12-9 Quality of SpO2 Waveform... 12-9 Stability of SpO2 Values... 12-10 Masimo SET Modules and Probes... 12-11 No Implied License... 12-11 Probes... 12-11 SpO2 Parameter Window Display... 12-12 SpO2 Information... 12-12 SpO2 Controls Window... 12-13 Pulse Volume... 12-14 Pulse Rate... 12-14 Waveform Size... 12-14

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Sat-Seconds Threshold... 12-14 Averaging Time... 12-14 Sensitivity... 12-15 SpO2 Controls... 12-15 Sat-Seconds Alarm Management... 12-16 Troubleshooting... 12-19 SpO2 Messages... 12-19 Clinical Questions... 12-20

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Cardiac Output Monitoring... 13-1 Introduction... 13-3 Cardiac Output Waveform... 13-4 Checklist... 13-5 Sensor Setups... 13-6 Bath Probe Setup... 13-6 In-Line Setup... 13-6 Cardiac Output Monitoring... 13-7 Suggested Cardiac Output Procedure... 13-7 Cardiac Output Parameter Window... 13-9 Cardiac Output Procedure Window... 13-10 Cardiac Output Controls Window... 13-12 Cardiac Calcs... 13-14 Introduction... 13-14 Monitored Parameters... 13-14 Calculated Parameters... 13-15 Cardiac Calcs Table... 13-16 Troubleshooting... 13-17 Procedural Prompts/Messages... 13-17 Error Messages... 13-18 Common Problems... 13-19

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Respiration Monitoring... 14-1 Introduction... 14-3 General Information... 14-4 Respiration Information... 14-6 Respiration Waveform... 14-6 Respiration Parameter Window... 14-6 Resp Controls Window... 14-7 Troubleshooting... 14-9 Respiratory Waveform... 14-9 Messages... 14-11

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Temperature Monitoring... 15-1 Introduction... 15-3 Checklist... 15-3 Temperature Monitoring Features... 15-4 Temperature Information... 15-4 Temperature Parameter Window... 15-4 Temperature Monitoring... 15-5 Temperature Controls Window... 15-5 Troubleshooting... 15-6 Messages... 15-6

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SvO2 Monitoring... 16-1 Introduction... 16-3 Checklist... 16-4 Signal and Data Validity... 16-4 SvO2 Calibration... 16-5 Preinsertion Calibration... 16-5 Light Intensity Calibration... 16-6 Calibrate to Venous Blood Gas... 16-7 SvO2 Parameter Window... 16-8 SvO2 Controls Window... 16-9 SvO2 Calibration... 16-9 Cal Messages... 16-9 SvO2 Controls... 16-9 Troubleshooting... 16-10 Optical Module Test Procedure... 16-11

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CO2 Monitoring... 17-1 Introduction... 17-3 CO2 Monitoring Features... 17-4 CO2 Parameter Window... 17-4 Capnostat Modules... 17-5 General Information... 17-5 Mainstream Setup... 17-7 Sidestream Setup (Dual Module)... 17-8 CO2 Monitoring... 17-11 Zero Capnostat Sensor... 17-14 Calibrate Capnostat Adapter... 17-15 Capnostat Sensor and Adapter Cleaning... 17-16 Cleaning the Capnostat Sensor... 17-16 Cleaning the Reusable Capnostat Adapters... 17-16 Capnostat Sensor Troubleshooting... 17-17 Capnostat Sensor Check... 17-17

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Sidestream CO2 Module... 17-18 Sidestream Module Setup... 17-19 CO2 Monitoring... 17-21 SAM Module... 17-23 CO2 Monitoring... 17-23 RAMS Unit... 17-26 CO2 Monitoring... 17-26 CO2 Calibration... 17-28 Calibrating the CO2 Adapter... 17-28 Calibrating the SAM Module... 17-29 Troubleshooting... 17-30 Messages... 17-30

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Anesthesia Gas Monitoring... 18-1 Introduction... 18-3 SAM Module... 18-4 Introduction... 18-4 Safety Information... 18-5 Setup... 18-6 Checklist... 18-7 RAMS M-200... 18-8 Introduction... 18-8 RAMS M-200 Control Panel Features... 18-10 Safety Information... 18-11 Setup... 18-13 Checklist... 18-16 Aqua-Knot Water Trap... 18-17 User Information... 18-17 Gas Monitoring... 18-18 Parameter Window Displays... 18-18 Gas Controls Window... 18-20 Gas Mixtures... 18-22 Troubleshooting... 18-23

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Interfaces... 19-1 Introduction... 19-3 Safety... 19-5 Unity Network ID Connectivity Device... 19-6 Interconnection... 19-6 Serial Port Indicator Lights... 19-7 Displayed Data... 19-8 Parameters... 19-8 Parameter Windows and Menus... 19-9 Software Compatibility... 19-13 Device-Specific Information... 19-14 Notification of Equipment Upgrade... 19-15

Appendix A – Analog Output...A-1 Tram Acquisition Modules... A-3 ECG Analog Output...A-3 BP Analog Output...A-3 Digital Synchronization Output...A-4 Tram-rac Housing... A-5 ECG Analog Output...A-5 BP Analog Output...A-5

Appendix B – Battery Information...B-1 Ni-Cd Battery Specifications... B-3 Battery Pack Specifications...B-3 Battery Protection Specifications...B-3 Recycling Information... B-4

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Appendix C – Supplies...C-1 Appendix D – Abbreviations and Symbols...D-1 Abbreviations... D-3 Symbols... D-13

Index... INDEX-1

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For your notes

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The Basics

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For your notes

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