Transport Pro™ Operators Manual Software Ver 2 Rev B

NOTE: The information in this manual applies to Transport Pro Patient Monitor software version 2. 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. DASH, RAC, SOLAR, TRAM, TRAM-NET, TRAM-RAC, TRIM KNOB, and UNITY NETWORK are trademarks of GE Medical Systems Information Technologies registered in the United States Patent and Trademark Office. 12SL, MENTOR, TRANSPORT PRO, and UNITY are trademarks of GE Medical Systems Information Technologies. © 2005 General Electric Company. All rights reserved.

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CE Marking Information

CE Marking Information Compliance The Transport Pro 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”. 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.

Exceptions The Transport Pro EMC: Immunity Performance There are no safety and/or EMC compliance exceptions with this product. Users should be aware of known RF sources, such as radio or TV stations and hand-held 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 EMI performance. Consult with qualified personnel regarding changes to the system configuration.

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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 device is used in accordance with the instructions for use.

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All publications are in conformity with the product specifications and EN publications on safety of electromedical equipment as well as with 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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Contents

1

The Basics... 1-1 About This Manual... 1-3 Manual Purpose... 1-3 Intended Audience... 1-3 Revision History... 1-3 Ordering Manuals... 1-3 Manual Conventions... 1-4 Definitions... 1-4 Illustrations and Names... 1-4 Equipment Overview... 1-5 Transport Monitoring System... 1-5 Acquisition Device and Docking Station... 1-8 Controls and Indicators... 1-9 Turning Power On... 1-12 External Power Supply... 1-12 Battery Power... 1-12 Software Overview... 1-13 Transport Monitor Display... 1-13 Menus... 1-13 Popup Menus... 1-15 Subordinate Menus... 1-17 Direct Action Menu Options... 1-18 Parameter Windows... 1-19 Information Windows... 1-20 Trim Knob Control Operation When Setting Alarm Limits... 1-21 Putting the Transport Monitor Into Operation... 1-22 Transport Monitor Installation and Connection... 1-22 Performance Check... 1-23 Language-Specific Information... 1-24 Chinese and Japanese Language Information... 1-24 French Language Information... 1-24

2

Safety... 2-1 For Your Safety... 2-3 Intended Use... 2-3

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Terminology... 2-4 Transport Monitor Safety... 2-5 Reference Literature... 2-12 Classifications... 2-13 Underwriters Laboratories, Inc... 2-13 Equipment Symbols... 2-13

3

Maintenance... 3-1 Biocompatibility... 3-3 Inspection... 3-4 Cleaning... 3-5 General Cleaning/Disinfecting... 3-5 Cleaning the Display... 3-7 Cleaning Other Applied Parts... 3-7 More Intensive Disinfecting or Sterilization... 3-7 Technical Maintenance... 3-8 Safety Tests... 3-8

4

Batteries... 4-1 Battery Power... 4-3 Battery System Run Time... 4-4 Battery Indicators... 4-5 Transport Indicators... 4-5 Battery Capacity Gauge... 4-6 On-screen Capacity Gauges... 4-6 Capacity Gauges on the Battery... 4-8 Battery Maintenance... 4-9 How to Charge the Battery... 4-9 How to Condition the Battery... 4-10 How to Wake Up the Battery... 4-12 How to Store the Battery... 4-13 The Cadex SMart Two+ Charger... 4-14 Replacing the Battery... 4-15 How to Replace the Transport Battery... 4-15

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Recycle the Battery... 4-16 Rechargeable Battery Collection Sites... 4-16 Battery Status Menu... 4-17 Battery Help... 4-18 Battery Alarms... 4-19 Battery LEDs will not Illuminate... 4-20

5

Monitor Setup... 5-1 Monitor Setup Menu... 5-3 Waveforms On/Off... 5-4 Display... 5-6 Color... 5-7 Parameters On/Off... 5-8 Monitor Defaults... 5-9 Monitor Defaults Password... 5-18 Brightness... 5-19 Learn the Monitor... 5-20 Software Configuration... 5-21 Revision and ID... 5-22 Service Mode... 5-23

6

Admitting and Transporting a Patient... 6-1 Admitting a Patient... 6-3 Acquisition Device Connected to the Transport Monitor... 6-3 Acquisition Device Not Connected to the Transport Monitor... 6-4 TRAM Module Connected to Two Monitors... 6-5 Admit Menu... 6-6 Admit Menu Options... 6-7 Change Admit Info... 6-7 Units of Measure... 6-9 Discharging a Patient... 6-10 Transporting a Patient... 6-11 Mounting Configurations... 6-12

7

Alarm Control... 7-1 Smart Alarms... 7-3

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Alarm Structure... 7-4 Patient Status Alarms... 7-4 System Status Alarms... 7-5 On-Screen Alarm Help... 7-5 Controlling Audio Alarms... 7-6 Silencing Alarms... 7-6 Pausing Alarms... 7-7 Pausing and Silencing Alarms on Multiple Monitors... 7-8 Alarm Pause Breakthrough... 7-8 Alarm Window... 7-9 Clear Alarms... 7-9 Alarm Control Menu... 7-10 All Limits... 7-10 Arrhythmia Alarm Level... 7-11 Parameter Alarm Level... 7-12 Alarm Volume... 7-13 Alarm Help... 7-14 Clear Alarms... 7-14

8

Patient Data... 8-1 Patient Data Menu... 8-3 Graphic Trends... 8-3

9

ECG... 9-1 Introduction... 9-3 ECG Checklist... 9-3 Skin Preparation... 9-4 Electrode Placement... 9-5 5-Leadwire Electrode Placement... 9-5 3-Leadwire Electrode Placement... 9-6 Electrode Placement for Neonates... 9-7 Electrode Placement for Pacemaker Patients... 9-8 Maintaining Quality ECG Signal... 9-9 Surgical Considerations for Electrode Placement (Adults)... 9-9 ESU ECG Filters... 9-10 Electrosurgical Unit (ESU) Cable... 9-10 ECG Display... 9-11 Getting to the ECG Menu... 9-12

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ECG Menu Options... 9-13 Display Lead... 9-13 ECG Size... 9-15 Detect Pace... 9-16 ECG Limits... 9-21 View All ECG... 9-22 Arrhythmia... 9-23 Relearn... 9-28 More ECG... 9-28 Troubleshooting... 9-30 Pacemaker Troubleshooting... 9-31

10

Pressures... 10-1 Introduction... 10-3 Assigned Pressure Names... 10-3 Zero Reference... 10-5 Pressures Checklist... 10-5 Pressure Monitoring Features... 10-6 Pressure Information... 10-6 Getting to the Pressure Menu... 10-7 Pressure Menu Options... 10-8 Scales... 10-8 Cursor... 10-9 Clear Cursor... 10-10 Limits... 10-10 Change Name... 10-11 Zero... 10-12 BP Filter... 10-12 Speed... 10-12 Special Features... 10-13 IABP... 10-13 Using the IABP Feature... 10-14 Pulse Rate... 10-17 Troubleshooting... 10-18

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NBP... 11-1 Introduction... 11-3 NBP Connectors... 11-4

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Safety... 11-5 NBP Checklist... 11-6 Patient Preparation... 11-7 NBP Monitoring Features... 11-8 NBP Information... 11-8 Getting to the NBP Menu... 11-10 NBP Menu Options... 11-11 NBP Auto... 11-11 NBP Stat... 11-12 NBP Limits... 11-13 Cuff Size... 11-14 Clear NBP Reading... 11-14 Troubleshooting... 11-15 NBP Status Messages... 11-15

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SPO2... 12-1 Introduction... 12-3 Acquisition Devices and Probe Compatibility... 12-4 Safety... 12-5 Measurements... 12-6 Neonates and Infants... 12-7 SPO2 Checklist... 12-8 Patient Preparation... 12-9 Signal and Data Validity... 12-10 Signal Strength Indicator... 12-10 Quality of SPO2 Waveform... 12-10 Stability of SPO2 Values... 12-11 Masimo SET Configuration and Probes... 12-12 No Implied License... 12-12 Probes... 12-12 SPO2 Monitoring Features... 12-13 SPO2 Information... 12-13 Getting to the SPO2 Menu... 12-14 SPO2 Menu Options... 12-15 Size... 12-15 Rate... 12-15

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Rate Volume... 12-15 SPO2 Limits... 12-16 Speed... 12-17 Probe Off Patient Condition... 12-18 Pulse Search Condition... 12-19 Troubleshooting... 12-20 SPO2 Messages... 12-20 Clinical Questions... 12-21

13

Respiration... 13-1 Introduction... 13-3 General Information... 13-4 Monitoring Respiration on Pacemaker Patients... 13-6 Respiration Checklist... 13-7 How to Start Respiration Monitoring... 13-8 Respiration Monitoring Features... 13-9 Respiration Information... 13-9 Getting to the Respiration Menu... 13-10 Respiration Menu Options... 13-11 Lead... 13-11 Relearn Respiration... 13-12 Sensitivity... 13-12 Respiration Limits... 13-13 Auto Size... 13-14 Manual Size... 13-14 Cardiact Artifact... 13-15 Speed... 13-15 Troubleshooting... 13-16 Respiratory Waveform... 13-16 Messages... 13-18

14

Temperature... 14-1 Introduction... 14-3 Temperature Checklist... 14-3 Temperature Monitoring Features... 14-4 Temperature Information... 14-4 Getting to the Temperature Menu... 14-5

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Temperature Menu Options... 14-6 T1... 14-6 T2... 14-6 Units... 14-6 Temperature Limits... 14-6 Troubleshooting... 14-8 Messages... 14-8

Appendix A – Supplies...A-1 Supplies... A-3

Appendix B - Adult-ICU Mode Defaults...B-1 TRAM Module Adult-ICU Mode Defaults... B-3

Appendix C - Neonatal-ICU Mode Defaults...C-1 TRAM Module Neonatal-ICU Mode Defaults... C-3

Appendix D - Operating Room Mode Defaults...D-1 TRAM Module Operating Room Mode Defaults... D-3

Appendix E - Monitor Defaults Worksheet...E-1 TRAM Module Monitor Defaults Worksheet... E-3

Appendix F – Abbreviations... F-1 Appendix G – Software Licenses Agreement... G-1 Xerces XML Parser License Agreement... G-3 Berkely License Agreement... G-4

Index... Index-1

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The Basics

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For your notes

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The Basics: About This Manual

About This Manual Manual Purpose This manual contains the instructions necessary to operate the transport monitor safely and in accordance with its function and intended use.

Intended Audience This manual is geared 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

Comments

A

Initial release of this document.

B

More battery information was added.

Ordering Manuals To order additional copies of this manual, call Accessories and Supplies and request part number 2024579-001. Refer to the How to Reach Us page for Accessories and Supplies contact information.

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The Basics: Manual Conventions

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

Definitions The following terms are used in this manual to describe various transport monitor features and functions. Term

Definition

transport monitor

Transport Pro Patient Monitor

acquisition device

TRAM module

docking station

TRAM chute

key

A labeled button found on the front of the transport monitor.

menu

Text which appears at the bottom of the display screen. A menu is composed of a set of menu options.

menu option

A choice found in a menu. A menu option is enclosed by a rectangle.

screen text

Any text that appears on the transport monitor display screen. In this manual, screen text is shown in italics (for example, ECG, MAIN MENU, etc.).

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 transport 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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The Basics: Equipment Overview

Equipment Overview Transport Monitoring System The transport monitoring system consists of the following components: „

Transport Pro monitor/processing unit

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TRAM module

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TRAM chute

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Interconnection cable

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Transport monitor batteries (two)

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External power supply (AC adapter)

The components of the system are discussed on the following pages. For complete setup information, refer to the service manual.

Front View Keys are located on the front of the transport monitor. Refer to “Controls and Indicators” on page 1-9 for information about their functions.

835C

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The Basics: Equipment Overview

Alarm Light Indicator An alarm light indicator is built into the display bezel of the transport monitor. When activated, the LED indicator flashes red for CRISIS patient status alarms and yellow for WARNING patient status alarms and system status alarms. Alarm Light Indicator

859B

Alarm Light Indicator

Left Side View The TRAM module attach to the back of the transport monitor via the TRAM chute. The battery compartments are located on the left side of the transport monitor.

Battery Compartments

857C

Side View of Monitor with TRAM Module Connected

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Right Side View The connectors are located on the right side of the transport monitor. Refer to the service manual for system safety requirements when connecting the transport monitor to accessory equipment.

A

D B

C 858A

Right Side View of Transport Monitor A

Video In connector. The TRAM interconnection cable plugs in here. 834A

B

Ethernet connector. This connector is used for software updates. Refer to the service manual for more information. 593A

C 868A

D 833A

Revision B

NOTE Networking via the Ethernet connector is not available. Main processor diagnostic LEDs. The main processor PCB provides three LEDs to help troubleshoot the transport monitor. Refer to the service manual for more information. Power connector. The external power supply connects here.

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The Basics: Equipment Overview

Acquisition Device and Docking Station TRAM Modules The transport monitor displays data acquired from a TRAM module.

TRAM Chute The TRAM chute attaches to the back of the transport monitor and holds one TRAM module. Refer to the service manual for TRAM chute installation information.

How to Install and Remove a TRAM Module To install a module follow this procedure: 1. Facing the TRAM chute, guide the back end of the TRAM module into the slot. 2. Gently push the module into the chute. You will hear a click when the module is fully inserted. To remove a module follow this procedure: 1. Release levers are found on each side on the front of the TRAM module. 2. Press and hold the release levers simultaneously and pull the TRAM module out about 15 cm (six inches). 3. Once released, grasp the TRAM module firmly with both hands and remove the rest of the way. Do not try to hold the module by the release levers.

How to Connect the Transport Monitor to the TRAM Module To connect the transport monitor to the TRAM module, simply plug the transport monitor’s interconnection cable into the connector labeled DISPLAY on the front of the TRAM module. Plug the other end of the cable into the Video In connector on the monitor. NOTE On some TRAM modules, this connector is labeled DISPL.

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