MAC 5000 Operators Manual Rev C

NOTE: The information in this manual only applies to MAC 5000 System software version 008A. It does not apply to earlier software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice.

© 2003 GE Medical Systems Information Technologies, Inc. a division of General Electric Company. All rights reserved. MAC, MUSE, MUSE CV, Archivist, and MobileLink are trademarks owned by General Electric Company or by GE Medical Systems Information Technologies, Inc. All other marks are owned by their respective owners. Information contained in this document is proprietary to GE Medical Systems Information Technologies. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form, in whole or in part, by any means electronic, mechanical or other otherwise, including photocopying and recording, for any purpose without written permission of GE. T-2

21 October 2003

MAC 5000 System - PN 2015196-092, Revision C

CE Marking Information

CE Marking Information Compliance The MAC 5000 System 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. For devices manufactured in the United States, the CE mark is applied under the authority of Notified Body GMED (0459).

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 There are no exceptions.

The country of manufacture and appropriate Notified Body can be found on the equipment labeling. The product complies with the requirements of standard EN 60601-1-2 “Electromagnetic Compatibility - Medical Electrical Equipment”.

MAC 5000 System - 2015196-092, Revision C

CE-1

CE Marking Information

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GE Medical Systems Information Technologies GmbH Munzinger Strasse 3-5 Freiburg D79111 Germany Tel. +49-76145430 Fax. +49-7614543233

All products bear the CE mark "CE-0459", notified body GMED, indicating its conformity with the provisions of the Council Directive 93/42/EEC, concerning medical device and fulfills the essential requirements of Annex I of this directive.

Any other directive(s) and all the standards the product complies to are listed in the general information of the operator manual for the product following this page.

The authorized representative for GE Medical Systems Information Technologies Inc. in Europe is:

The country of manufacture can be found on the equipment labeling.

European Headquarters GE Medical Systems Information Technologies GmbH Postfach 60 02 65 79032 Freiburg Germany Tel.: + 49 761 45 43 - 0 Fax.: + 49 761 45 43 - 233

CE-2

World Headquarters GE Medical Systems Information Technologies Inc. 8200 West Tower Avenue Milwaukee, WI 53223 United States of America Tel.: + 1 414 355 5000 Fax.: + 1 414 355 3790

Asian Headquarters GE Medical Systems Information Technologies Asia GE (China) Co., Ltd. 24th Floor Shanghai MAXDO Centre, 8 Xing Yi Road Hong Qiao Development Zone Shanghai 200336 - People’s Republic of China Tel.: + 86 21 5257 4630 Fax.: + 86 21 5208 2006 MAC 5000 System - 2015196-092, Revision C

Contents CE Marking Information... CE-1 Compliance... CE-1 Exceptions... CE-1

1

Introduction... 1-1 Manual Information... 1-3 Purpose... 1-3 Intended Audience... 1-3 Revision History... 1-3 Conventions... 1-3 User Instructions... 1-4 Safety Information... 1-5 Definitions... 1-5 Equipment... 1-5 Legal Notice... 1-7 Responsibility of the Manufacturer... 1-7 General Information... 1-8 Equipment Symbols... 1-11 Service Information... 1-12 Service Requirements... 1-12 Equipment Identification... 1-12

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2

Equipment Overview... 2-1 Equipment Description... 2-3 Front View... 2-3 Internal View... 2-4 Back View... 2-5 Connectors... 2-6 Keyboard... 2-8 Keyboard–Exercise Test Keys (Option)... 2-9 Acquisition Module... 2-10 Getting Started... 2-13 Prepare the Equipment for Use... 2-13 Software Description... 2-15 Selecting Menu Functions... 2-19 Entering Data... 2-22

3

Preparing the Patient... 3-1 Prepare the Patient’s Skin... 3-3 Apply the Electrodes... 3-4 Resting Electrodes... 3-4 Exercise Electrodes (with Exercise–Option)... 3-9

4

Entering Patient Information... 4-1 Enter Patient Information... 4-3 Preparation... 4-3 Enter the Information... 4-4 Using a Patient Card Reader (Option)... 4-5 Connect and Configure The Card Reader... 4-5

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Slide Card... 4-5 Using a Bar Code Reader (Option)... 4-6 Connect and Configure the Bar Code Reader... 4-6 Scan the Bar Code... 4-6 Receive Orders From a MUSE CV System (Option)... 4-7 Preparation... 4-7 Load the Orders... 4-8 Select the Orders to Receive... 4-8 Select an Order to Complete... 4-9 Complete the Order... 4-9 Enter Orders Manually (Option)... 4-10 Preparation... 4-10 Create an Order... 4-10 Select an Order to Complete... 4-11 Complete the Order... 4-11

5

Recording an ECG... 5-1 Record a 15 Lead, Resting, Pediatric, or Vector Loops ECG... 5-3 Preparation... 5-3 Record the ECG... 5-3 Record a Signal Averaged ECG (Options)... 5-4 Preparation... 5-4 Record the ECG... 5-4 Record a Master’s Step Test (Option)... 5-5 Preparation... 5-5 Enter Patient Data... 5-5 Confirm Test Steps... 5-5

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Record the ECG... 5-5 Run the Test... 5-6 Using ACI-TIPI (Option)... 5-7 Preparation... 5-7 Enter the Information... 5-7

6

Exercise Stress Test (Option)... 6-1 Start an Exercise Stress Test... 6-3 Patient Data... 6-3 Exercise Test Keys... 6-4 Test Phases... 6-5 Pretest Phase... 6-5 Exercise Phase... 6-7 Recovery Phase... 6-9 Test End Phase... 6-10

7

Edit Protocols Options... 7-1 Overview... 7-3 Operating Steps... 7-4 Variable Protocols... 7-5 Pre-Test Phase Screen... 7-6 Pre-Test Protocol Information... 7-7 Advance to Exercise... 7-8 Advance to Recovery... 7-9 Advance to Test End... 7-10 Save Current Protocol... 7-11

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8

Printing an ECG Report... 8-1 Print Stored ECG Reports... 8-3 Preparation... 8-3 Select the ECGs... 8-3 Print the ECGs... 8-3

9

Transmitting an ECG... 9-1 Transmit Stored ECGs by Modem (Option)... 9-3 Preparation... 9-3 Select the Receiving Device... 9-4 Select the ECGs... 9-4 Transmit the ECGs... 9-4 Transmit Stored ECGs Locally... 9-5 Preparation... 9-5 Select the Method of Transmission... 9-6 Select the ECGs... 9-6 Transmit the ECGs... 9-6 Transmit Stored ECGs by Wireless (Option)... 9-7 Preparation... 9-7 Select the Receiving Device... 9-7 Select the ECGs... 9-7 Transmit ECGs... 9-8 Transmit Stored ECGs to the Serial Port in XML Format... 9-9 Preparation... 9-9 Select the Location... 9-9 Select the ECGs... 9-9 Transmit the XML Files... 9-9

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10 Receiving an ECG... 10-1 Receive ECGs by Modem (Option)... 10-3 Preparation... 10-3 Receive the ECGs... 10-4 Receive ECGs Locally... 10-5 Preparation... 10-5 Receive the ECGs... 10-6 Retrieve Confirmed ECGs from a MUSE CV System via Modem (Option)... 10-7 Preparation... 10-7 Select a MUSE CV System... 10-8 Select an ECG... 10-9 Display or Print the ECG... 10-9 Retrieve Confirmed ECGs from a MUSE CV System via Wireless (Option)... 10-10 Preparation... 10-10 Select a MUSE CV System... 10-11 Select an ECG... 10-11 Display or Print the ECG... 10-12

11 Editing an ECG... 11-1 Edit Demographic and Interpretive Data... 11-3 Preparation... 11-3 Select the ECGs... 11-3 Edit Demographic Data... 11-4 Edit Interpretive Data... 11-4 Store the Edited ECG... 11-7

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12 Deleting an ECG... 12-1 Delete Stored ECGs... 12-3 Preparation... 12-3 Select the ECGs... 12-3 Delete the ECGs... 12-4 Delete Stored ECG Orders (Option)... 12-5 Preparation... 12-5 Select the Orders... 12-5 Delete the Orders... 12-6

13 Completing Other Tasks... 13-1 Prepare a Disk for Use... 13-3 Lock and Unlock... 13-3 Format... 13-3 Eject a Disk From the Drive Slot... 13-4 Display Stored ECGs... 13-5 Preparation... 13-5 Select the ECGs... 13-5 Display the ECGs... 13-6

14 Defining the System Setup... 14-1 To Use the System Setup Function... 14-3 Select the System Setup Function... 14-3 Define the System Parameters... 14-4 Save Your Changes... 14-4 Program the System to Automatically do a Task... 14-5 To Power Up the System into a Specific Resting Function... 14-5 MAC 5000 System - 2015196-092, Revision C

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To Preview ECG Data Before Analysis... 14-5 To Print a Resting ECG Report... 14-6 To Print a Signal Averaged ECG Report... 14-6 To Store an ECG... 14-7 To Transmit an ECG... 14-7 Enable or Disable the ACI-TIPI Option... 14-8 Define the Basic System Setup... 14-9 Miscellaneous Setup... 14-9 Patient Questions... 14-10 Screen Colors... 14-12 Transmission... 14-13 Date and Time... 14-14 Language... 14-14 Power Up Options... 14-15 Order Manager Interface... 14-15 PS/2 Port... 14-16 Define the ECG Setup... 14-17 ECG Acquisition/Analysis... 14-17 Patient Questions... 14-19 Writer Setup... 14-19 Resting, Pediatric, 15 Lead, and Vector Loops ECG Reports... 14-20 Analog Outputs... 14-24 Define the Exercise Test Setup (Option)... 14-25 Miscellaneous Setup... 14-25 Patient Data/Questions... 14-25 Writer Setup... 14-26 12 and 15 Lead Exercise Reports... 14-27 Final Report... 14-29 viii

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Screen... 14-30 Inputs / Outputs... 14-30 Define the Signal Averaged ECG Setup (Option)... 14-32 Card Reader Option Setup... 14-33 Automatic Configuration of Card Reader... 14-33 Manual Configuration of Card Reader... 14-34 Bar Code Reader Option Setup... 14-35 Automatic Configuration of Bar Code... 14-35 Manual Configuration of Bar Code Reader... 14-36 Creating Bar Codes and Magnetic Cards... 14-36 Master’s Step Setup (Option)... 14-38 Miscellaneous Setup... 14-39 Print Setup... 14-39 Save Setup... 14-39 Restore Setup... 14-39

Appendices

Appendix A – Maintenance... A-1 General... A-3 Inspecting and Cleaning... A-4 Precautions... A-4 Visual Inspection... A-4 Cleaning... A-5 Changing the Paper Tray Size... A-6 To Change to A4 Paper Size... A-6 To Change to Standard Paper Size... A-6 Replacing Paper... A-7 Storing Paper... A-8

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Thermal Paper... A-8 Archivist Paper... A-9 Maintaining the Battery... A-10 Battery Gauge Icon... A-10 Charging the Battery... A-10 Periodic Maintenance... A-12 Replacing the Battery... A-12 Replacing Acquisition Module Leadwire Adapters... A-14 Handling a Disk... A-15

Appendix B – Troubleshooting... B-1 Introduction... B-3 First Things to Ask... B-3 Visual Inspection... B-3 Equipment Problems... B-4 Reducing ECG Data Noise... B-4 There is No ACI-TIPI Report... B-4 No BP Readings from External Device... B-5 Treadmill / Ergometer Does Not Move... B-5 System Errors... B-6

Appendix C – Editing Acronyms... C-1 Resting ECG Acronyms... C-3

Appendix D – Report Formats... D-1 Format Description... D-3 4 by 2.5s + 1 Rhythm Lead Format... D-3 x

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Key to Bottom of Exercise Reports... D-4 Additional Report Names... D-5 In-Test Reports... D-7 Exercise Final Report Names... D-8

Appendix E – Master’s Step Data... E-1 Master’s Step Table... E-3 ST-T Change... E-5 Positive... E-5 Borderline... E-5 Negative... E-5 Calculation... E-5

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For your notes

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1

MAC 5000 System - 2015196-092, Revision C

Introduction

1-1

For your notes

1-2

MAC 5000 System - 2015196-092, Revision C

Introduction: Manual Information

Manual Information Purpose

Conventions

This manual contains the instructions necessary to operate the MAC 5000 system in accordance with its function and intended use.

Note

9 Provides additional user information. Styles

Intended Audience This manual is intended for the person who uses, maintains, or troubleshoots this equipment.

Bold text Indicates keys on the keyboard, text to be entered, or hardware items such as buttons or switches on the equipment. Italicized Indicates software terms that identify menu items, buttons, or text options in various windows.

Revision History Each page of the document has the document part number and revision letter at the bottom of the page. The revision letter identifies the document’s update level.

Ctrl+esc

Table 1. Revision History, PN 2015196-092 Revision

Date

Comment

A

25 July 2003

Initial release.

B

5 September 2003 Added information about XML file.

C

21 October 2003

Added leadwire caution and bar code reader note.

MAC 5000 System - 2015196-092, Revision C

Indicates a keyboard operation. A (+) sign between the names of two keys indicates that you must press and hold the first key while pressing the second key once. For example, “Press Ctrl+esc” means to press and hold down the Ctrl key while pressing the esc key.

<Space> Indicates you must press the spacebar. When instructions are given for typing a precise text string with one or more spaces, the point where the spacebar must be pressed is indicated as: <Space>. The purpose of the < > brackets is to ensure you press the spacebar when required. Enter

Indicates you must press the “Enter” or “Return” key on the keyboard. Do not type “enter”.

1-3

Introduction: Manual Information

User Instructions Pictures show you which key to press, screen item to select, or action you must do to complete a task.

H

A

Your Action A

Press the F key located below the desired screen menu item.

B

Press to close a screen menu.

C

Press to turn the system power on or off as indicated in the procedure.

D

Press to enter data into the system.

E

Press to acquire ECG data and to print or stop printing writer reports.

F

Insert or remove a diskette as indicated by the direction of the arrow.

G

Press to perform various exercise test functions and adjust test variables.

H

Select the displayed screen item.

B G C F

D E

002B

1-4

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