Transport Pro™ Operators Manual Software Ver 2.1

NOTE The information in this manual applies to Transport Pro Patient Monitor software version 2.1. 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. DASH, SOLAR, TRAM, TRIM KNOB, and UNITY NETWORK are trademarks of GE registered in the United Stated Patent and Trademark Office. 12SL, 12RL, CARESCAPE, PATIENT DATA MODULE, and TRANSPORT PRO are trademarks of GE.

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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™ Patient Monitor 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 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 EMI 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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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.

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

means ATTENTION: Consult accompanying documents.

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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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Compliance

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CE-2

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 applicable IEC publications on safety and essential performance 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... 1-2 Manual Purpose... 1-2 Intended Audience... 1-2 Revision History... 1-2 Ordering Manuals... 1-2 Manual Conventions... 1-2 Definitions... 1-2 Text styles... 1-3 Illustrations and Names... 1-3 Equipment Overview... 1-3 Transport Pro Patient Monitoring System... 1-3 Acquisition Devices and Docking Stations... 1-7 Controls and Indicators... 1-9 Turning on the Power... 1-13 External Power Supply... 1-13 Battery Power... 1-14 Software Overview... 1-14 Transport Monitor Display... 1-14 Menus... 1-14 Popup Menus... 1-16 Subordinate Menus... 1-17 Direct Action Menu Options... 1-18 Parameter Windows... 1-18 Information Windows... 1-19 Trim Knob Control Operation When Setting Alarm Limits... 1-20 Putting the Transport Monitor Into Operation... 1-21 Transport Monitor Installation and Connection... 1-21 Performance Check... 1-22 Language-Specific Information... 1-23 Chinese and Japanese Language Information... 1-23 French Language Information... 1-23

2

Safety... 2-1 For Your Safety... 2-2 Intended Use... 2-2 Terminology... 2-2 Transport Monitor Safety... 2-3

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Classifications... 2-12 Equipment Symbols... 2-13

3

Maintenance... 3-1 Biocompatibility... 3-2 Inspection... 3-2 Cleaning... 3-2 General Cleaning/Disinfecting... 3-3 Cleaning, Disinfecting and Storing GE ECG Cables and Leadwires... 3-3 Cleaning the Display... 3-5 Cleaning Other Applied Parts... 3-6 More Intensive Disinfecting or Sterilization... 3-6 Technical Maintenance... 3-6 Safety Tests... 3-6

4

Batteries... 4-1 Battery Power... 4-2 Battery System Run Time... 4-2 Battery Indicators... 4-3 Transport Monitor Indicators... 4-3 Patient Data Module Indicators... 4-3 Battery Capacity Gauges... 4-4 On-screen Capacity Gauges... 4-4 Capacity Gauges on the Batteries... 4-5 Battery Maintenance... 4-7 How to Charge the Battery... 4-7 How to Condition the Battery... 4-8 How to Wake Up the Battery... 4-9 How to Store the Battery... 4-11 The Cadex SMart Two+ Charger... 4-11 Battery Charger LED Indicators... 4-11 Replacing the Battery... 4-11 Safety... 4-11 How to Replace the Transport Monitor Battery... 4-12 How to Replace the PDM Battery... 4-13 Recycle the Battery... 4-14 Battery Status Menu... 4-14 TRAM Module Battery Status Window... 4-14

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PDM Battery Status Window... 4-15 Battery Help... 4-16 Battery Alarms... 4-17 Overview... 4-17 ERROR is Displayed in the Battery Capacity Gauge Icon... 4-17 Battery LEDs will not Illuminate... 4-18

5

Monitor Setup... 5-1 Monitor Setup Menu... 5-2 Overview... 5-2 Waveforms On/Off... 5-2 Display... 5-4 Color... 5-5 Parameters On/Off... 5-6 Monitor Defaults... 5-7 Monitor Defaults Password... 5-14 Brightness... 5-15 Learn the Monitor... 5-16 Software Configuration... 5-16 Revision and ID... 5-17 Service Mode... 5-18

6

Admitting and Transporting a Patient... 6-1 Admitting a Patient... 6-2 Acquisition Device Connected to the Transport Monitor... 6-2 Acquisition Device Not Connected to the Transport Monitor... 6-3 TRAM Module Connected to Two Monitors... 6-4 Admit Menu... 6-4 Admit Menu Options... 6-5 Change Admit Info... 6-5 Transfer of Admit Information to the Transport Monitor... 6-7 Units of Measure... 6-7 Recall Default... 6-8 Discharging a Patient... 6-8 Transporting a Patient... 6-8 Transport Monitor with Patient Data Module... 6-8 Transport Monitor with TRAM Module... 6-9 Mounting Configurations... 6-10

7

Alarm Control... 7-1 Smart Alarms... 7-2

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Alarm Structure... 7-2 Patient Status Alarms... 7-2 System Status Alarms... 7-3 Alarm Light Functionality During Multiple Alarm Events... 7-4 On-Screen Alarm Help... 7-4 Controlling Audio Alarms... 7-4 Silencing Alarms... 7-4 Pausing Alarms... 7-5 Pausing and Silencing Alarms on Multiple Monitors... 7-5 Alarm Pause Breakthrough... 7-6 Alarm Window... 7-6 Overview... 7-6 Clear Alarms... 7-7 Alarm Control Menu... 7-7 Menu... 7-7 All Limits... 7-8 Arrhythmia Alarm Level... 7-9 Parameter Alarm Level... 7-9 Alarm Volume... 7-10 Alarm Help... 7-11 Clear Alarms... 7-11 Alarm Pause... 7-11

8

Patient Data... 8-1 Patient Data Menu... 8-2 Overview... 8-2 Graphic Trends... 8-2

9

ECG... 9-1 Introduction... 9-2 Skin Preparation... 9-2 Electrode Placement... 9-3 Leadwires... 9-3 3-Leadwire Electrode Placement... 9-3 5-Leadwire Electrode Placement... 9-4 6-Leadwire Electrode Placement... 9-5 Electrode Placement for Neonates... 9-6 Electrode Placement for Pacemaker Patients... 9-6 Maintaining Quality ECG Signal... 9-7 Surgical Considerations for Electrode Placement (Adults)... 9-7 ESU ECG Filters... 9-7 Electrosurgical Unit (ESU) Cable... 9-7 ECG Display... 9-7

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Overview... 9-7 Getting to the ECG Menu... 9-8 ECG Menu Options... 9-9 Display Lead... 9-9 ECG Size... 9-11 Detect Pace... 9-11 ECG Limits... 9-15 View All ECG... 9-17 Update Lead Set... 9-17 Arrhythmia... 9-17 Relearn... 9-22 Identify V Lead and VB Lead... 9-22 More ECG... 9-23 Troubleshooting... 9-25 Inaccurate Heart Rate and/or False Asystole... 9-25 False Ventricular Calls... 9-25 Pacemaker Troubleshooting... 9-26

10

Pressures... 10-1 Introduction... 10-2 Invasive Pressure Connectors... 10-2 Assigned Pressure Names... 10-3 Invasive Pressure Y-Adapter Cable... 10-4 Zero Reference... 10-4 Pressures Checklist... 10-5 Pressure Monitoring Features... 10-5 Pressure Information... 10-5 Getting to the Pressure Menu... 10-6 Pressure Menu Options... 10-7 Scales... 10-7 Cursor... 10-8 Clear Cursor... 10-9 Limits... 10-9 Change Name... 10-10 Zero... 10-11 IABP... 10-11 Using the IABP Feature... 10-12 Pulse Rate... 10-15 Disconnect Alarm... 10-15 BP Filter... 10-15 Speed... 10-16 Troubleshooting... 10-16

11

NBP... 11-1 Introduction... 11-2

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NBP Connectors... 11-2 Safety... 11-3 Checklist... 11-5 Patient Preparation... 11-6 NBP Monitoring Features... 11-7 NBP Information... 11-7 Getting to the NBP Menu... 11-8 NBP Menu Options... 11-9 NBP Auto... 11-9 NBP Auto... 11-10 NBP Stat... 11-11 NBP Limits... 11-11 Cuff Size... 11-12 Clear NBP Reading... 11-13 Troubleshooting... 11-13 NBP Status Messages... 11-13 Erroneous NBP Measurement... 11-14

12

SpO2... 12-1 Introduction... 12-2 Acquisition Devices and Probe Compatibility... 12-2 Safety... 12-3 Neonates and Infants... 12-4 SpO2 Checklist... 12-5 Patient Preparation... 12-5 Signal and Data Validity... 12-6 Overview... 12-6 Signal Strength Indicator... 12-6 Quality of SpO2 Waveform... 12-6 Stability of SpO2 Values... 12-7 Masimo SET Configuration and Probes... 12-8 Overview... 12-8 No Implied License... 12-8 Probes... 12-8 SpO2 Monitoring Features... 12-9 SpO2 Information... 12-9 Getting to the SpO2 Menu... 12-9

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SpO2 Menu Options... 12-10 Size... 12-10 Rate... 12-10 SPO2 Volume... 12-10 SPO2 Limits... 12-11 Persistent... 12-12 Sensitivity... 12-12 Averaging... 12-13 Speed... 12-13 Probe Off Patient Condition... 12-13 Pulse Search Condition... 12-13 Connect Probe Condition... 12-13 Troubleshooting... 12-14 SpO2 Messages... 12-14 Clinical Questions... 12-15

13

Respiration... 13-1 Introduction... 13-2 General Information... 13-2 Monitoring Respiration on Pacemaker Patients... 13-4 Respiration Checklist... 13-4 How to Start Respiration Monitoring... 13-5 Procedure... 13-5 Special Conditions for Respiration Monitoring on Multiple Monitors... 13-5 Respiration Monitoring Features... 13-6 Respiration Information... 13-6 Getting to the Respiration Menu... 13-6 Respiration Menu Options... 13-7 Lead... 13-7 Relearn Respiration... 13-8 Sensitivity... 13-8 Respiration Limits... 13-8 Auto Size... 13-9 Manual Size... 13-10 Cardiac Artifact... 13-10 Speed... 13-10 Troubleshooting... 13-10 Respiratory Waveform... 13-10 Messages... 13-12

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Temperature... 14-1 Introduction... 14-2 Temperature Checklist... 14-2 Temperature Monitoring Features... 14-2 Temperature Information... 14-2 Getting to the Temperature Menu... 14-3 Temperature Menu Options... 14-4 T1... 14-4 T2... 14-4 Units... 14-4 Temperature Limits... 14-4 Troubleshooting... 14-5 Messages... 14-5

A

Appendix A – Supplies... A-1 Supplies... A-2

B

Appendix B - Adult-ICU Mode Defaults... B-1 Patient Data Module Adult-ICU Mode Defaults... B-2 TRAM Module Adult-ICU Mode Defaults... B-6

C

Appendix C - Neonatal-ICU Mode Defaults... C-1 Patient Data Module Neonatal-ICU Mode Defaults... C-2 TRAM Module Neonatal-ICU Mode Defaults... C-6

D

Appendix D - Operating Room Mode Defaults . . . D-1 Patient Data Module Operating Room Mode Defaults... D-2 TRAM Module Operating Room Mode Defaults... D-6

E

Appendix E - Monitor Defaults Worksheet... E-1 Patient Data Module Monitor Defaults Worksheet... E-2 TRAM Module Monitor Defaults Worksheet... E-7

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F

Appendix F - Technical Specifications... F-1 Technical Specifications... F-2

G

Appendix G – Abbreviations... G-1 Abbreviations... G-2

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The Basics

About This Manual Manual Purpose This manual contains the instructions necessary to operate the Transport Pro Patient 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.

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.

Definitions The following terms are used in this manual to describe various Transport Pro Patient Monitor features and functions.

Term

1-2

Definition

transport monitor

Transport Pro Patient Monitor

acquisition devices

Patient Data Module (also referred to as PDM) and TRAM module

docking stations

PDM dock and TRAM chute

key

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

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The Basics

Term

Definition

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 bold italics (for example, ECG, MAIN MENU, etc.).

Text styles This manual uses the following text styles to identify hardware terms, software terms and the correct way to enter data. Style

Definition

Bold

Indicates hardware items, such as keys, 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 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.

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

Transport Monitor with Patient Data Module

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Transport Monitor with TRAM module

Transport Pro Patient Monitor

Transport Pro Patient Monitor

Patient Data Module (PDM)

TRAM module

PDM dock

TRAM chute

PDM battery

Interconnection cable

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The Basics

Transport Monitor with Patient Data Module

Transport Monitor with TRAM module

Transport monitor batteries

Transport monitor batteries

External power supply (AC adapter)

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. See Controls and Indicators on page 1-9.

853D

Alarm Light Indicator An alarm light indicator is built into the top of the transport monitor. When activated, the alarm light indicator flashes red for CRISIS patient status alarms, flashes yellow for WARNING patient status and system status alarms, and illuminates yellow (no flashing) for ADVISORY patient status and system status alarms. See Alarm Structure on page 7-2.

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The Basics

Alarm Light Indicator

859B

Alarm Light Indicator

Left Side View Acquisition modules attach to the back of the transport monitor via the PDM dock or 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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The Basics

PDM Dock Locking Tab

856A

Side View of Monitor with Patient Data Module Connected

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.

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The Basics

A

D B

C 858B

Right Side View of Transport Monitor

A

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

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

B

NOTE 593A

Networking via the Ethernet connector is not available. C 868A

D

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.

836A

Acquisition Devices and Docking Stations The transport monitor can use either the Patient Data Module and PDM dock, or TRAM module and TRAM chute.

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