Philips PageWriter TC70, PageWriter TC50 User manual

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PageWriter TC70/TC50 Cardiograph

INSTRUCTIONS FOR USE

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Notice

About This Edition

Published by Philips Medical Systems

Printed in USA Publication number

453564164431

Edition History

Edition 1, June 2009 Software Revision A.03.00 and higher

Edition 2, March 2010 Software Revision A.04.01 and higher

Warranty

Philips Medical Systems reserves the right to make changes to both this Instructions for Use and to the product that it describes. Product specifications are subject to change without notice.

Nothing contained within this Instructions for Use is intended as any offer, warranty, promise, or contractual condition, and must not be taken as such.

Philips Electronics N.V. All rights are reserved. All other product names are the property of their respective owners.

Reproduction in whole or in part in any form, or by any means, electrical, mechanical or otherwise, is prohibited without the written consent of the copyright holder.

Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 USA (978) 687-1501

Unauthorized copying of this publication may not only infringe copyright laws, but may also reduce the ability of Philips Medical Systems to provide accurate and current information to users.

Compliance

The Philips Medical Systems PageWriter TC70 cardiograph and PageWriter TC50 cardiograph comply with all relevant international and national standards and laws. Information on compliance will be supplied on request by a local Philips Medical Systems representative, or by the manufacturer.

Intended Use of this Instructions for Use

This Philips product is intended to be operated only in accordance with the safety procedures and operating instructions provided in this Instruc- tions for Use, and in accordance with the purposes for which it was designed. Installation, use, and operation of this product is subject to the laws in effect in the jurisdiction(s) in which the product is being used. Users must only install, use, and operate this product in such a manner that does not conflict with applicable laws or regulations that have the force of law. Use of this product for purposes other than the express intended purpose provided by the manufacturer, or incorrect use and operation, may relieve the manufacturer (or agent) from all or some responsibility for resultant noncompliance, damage, or injury.

United States federal law restricts this device to use by or on the order of a physician. THIS PRODUCT IS NOT INTENDED FOR HOME USE.

Training

Users of this product must receive adequate clinical training on its safe and effective use before attempting to operate the product as described in this Instructions for Use.

Training requirements vary by country. Users must ensure that they receive adequate clinical training in accordance with local laws or regulations.

For further information on available training on the use of this product, please contact a Philips Medical Systems representative, or the manufacturer.

Medical Device Directive

The PageWriter TC70 cardiograph and PageWriter TC50 cardiograph comply with the requirements of the Medical Device Directive 93/42/ EEC and carries the

mark accordingly.

0123

Authorized EU-representative:

Philips Medizin Systeme Böblingen GmbH Hewlett Packard Str. 2 71034 Böblingen Germany

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Contents

About the PageWriter TC70 and PageWriter TC50 Cardiographs

About the Instructions for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-i

Safety Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-i

Symbols Marked on the Cardiograph or Patient Interface Module (PIM) . . . . . . . . . . . . .i-i

Safety Symbols Marked on the Cardiograph Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . .i-iv

Safety and Regulatory Symbols Marked on the PageWriter TC70 Cardiograph Cart. . . i-v Safety and Regulatory Symbols Marked on the PageWriter TC50 Cardiograph Cart. . . i-v Safety and Regulatory Symbols Marked on the PageWriter TC70 Cardiograph AC

Power Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-vi

Important Patient and Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i-vii

Accessories and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i-vii

AC Power Adapter and AC Power Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i-viii

Analog ECG Output Signal Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-ix

Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-ix

PageWriter TC50 Cardiograph One Battery Operation . . . . . . . . . . . . . . . . . . . . . . . . . i-x

Cart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i-x

Defibrillation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i-x

Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i-x

Display Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-x

ECG Interpretation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-xi

Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-xi

Faxed ECGs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-xi

General Cardiograph Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-xi

IEC 60601-2-51. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i-xii

Lead Wires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i-xii

Main Waveform Display Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i-xii

Modem Card and Fax Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i-xii

Pacemaker. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-xiii

Patient Data Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i-xiii

Patient Interface Module (PIM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-xiii

Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-xiv

Servicing the Cardiograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-xiv

Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-xiv

Touch Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-xiv

USB Memory Stick . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i-xv

The PageWriter TC70 Cardiograph and PageWriter TC50 Cardiograph . . . . . . . . . . . . . . i-xv

Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i-xv

Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-xvi

The Philips ECG Algorithm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-xvi

Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-xvi

Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-xvi

Contents-1

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Table of Contents

Chapter 1 Getting Started

PageWriter TC70/TC50 Cardiograph Learning Kit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

About the PageWriter TC70/TC50 Cardiograph Learning Kit . . . . . . . . . . . . . . . . . . . .1-2

Philips ECG XML Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

Using the Philips InCenter Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

About Adobe Acrobat Versions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

PageWriter TC70 Cardiograph Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

PageWriter TC50 Cardiograph Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9

Assembling the PageWriter TC70 Cardiograph Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-11

Assembling the PageWriter TC50 Cardiograph Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14

Using the Cart Wheel Positioners and Brake . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19

Patient Interface Module (PIM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20

About Class A and Class B Patient Data Cables and PIMs . . . . . . . . . . . . . . . . . . . . . . .1-21

Attaching the Patient Data Cable to the PIM and Cardiograph . . . . . . . . . . . . . . . . . . .1-22

Special Note about Patient Interface Module (PIM) . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24

PIM ECG Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-25

Configuring the 16-Lead PIM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-26

Recommended 16-Lead Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-28

Installing the Batteries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-29

Notes about Battery Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-29

Charging the Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-32

Calibrating the Batteries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-33

Battery Power Indicator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-33

Using the Wireless LAN Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-35

Using the Modem Card. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-36

Using the USB Memory Stick . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-36

Using the Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-37

Using the Cardiograph Touch Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-38

Touch Screen Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-39

Using the Main ECG Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-42

The Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-43

Supplies and Ordering Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-45

Ordering Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-45

Special Note about Welsh Bulb Electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-46

PageWriter TC70 and PageWriter TC50 Cardiograph Supply Part Numbers . . . . . . .1-46

PIM Patient Data Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-46

Complete Lead Sets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-47

Lead Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-47

Disposable and Reusable Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-48

Printer Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-49

Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-49

Keyboard Covers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-49

Replacement Fuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-49

USB Memory Stick . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-49

Ordering Options and Upgrades . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-50

Contents-2 PageWriter TC70/TC50 Cardiograph Instructions for Use

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Table of Contents

Product Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-51

Contacting a Philips Response Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-51

North America Response Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-51

South America Response Centers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-51

Europe Response Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-52

Asia Response Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-53

Africa and Middle East . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-54

Chapter 2 Configuring Default Clinical Settings

Configuring the Wireless LAN Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Password Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Tips for Creating Secure Passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Configuration with a Philips TraceMaster ECG Management System. . . . . . . . . . . . . . . . . . 2-1

Configuration with a Third Party ECG Management System . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Restoring Custom Configuration Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Configuring Multiple Cardiographs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Opening the Setup Screens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Using Online Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Configuring 12-Lead and 16-Lead Exam Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Chapter 3 The Patient Session

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Patient Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Instructing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Preparing the Skin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Electrode Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

Attaching Disposable Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

Attaching Welsh Bulb and Limb Clamp Electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

Attaching the Lead Wires. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14

Using the On/Standby Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15

Entering Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16

Required ID Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16

Navigating on the ID Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16

Entering ID Information with the Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17

Selecting an Order from the Worklist. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17

Searching for Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17

Editing ID Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18

Checking Signal Quality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19

Color-coded waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19

Leads Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20

Troubleshooting Signal Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20

Urgent (STAT) ECGs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24

Main ECG Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24

Changing the Lead Format on the Main ECG Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24

PageWriter TC70/TC50 Cardiograph Instructions for Use Contents-3

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Table of Contents

Taking an Auto ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25

Using the Preview Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26

Using the Last ECG Feature on the Preview Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . .3-28

Viewing Event Markers on the Preview Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-29

Critical Values on Preview Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-29

Very High Heart Rate Critical Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-30

Rhythm ECG Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-30

Special Note about Artifact Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-31

Disclose ECG Acquisition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-33

Event Marker Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-33

Capturing Events from the Main or Rhythm Screens . . . . . . . . . . . . . . . . . . . . . . . . . . .3-33

Reviewing Events on the Disclose Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-34

Reviewing Previous Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-37

Using Timed ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-37

Transferring ECGs from the Archive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-38

Downloading ECGs from TraceMaster . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-39

Chapter 4 Reading the Printed ECG Report

Interpretive, Reason, and Severity Statements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

Severity Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

Critical Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4

Basic Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5

About the Fridericia and Bazett’s Formula Rate-Corrected QT Interval Setting. . . . . . .4-5

Patient ID Clinical Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6

Patient ID Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7

Institution Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8

Configurable Clinical Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9

ECG Order Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11

Physician Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12

Report Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12

Calibration Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13

Time Separator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15

Pacing Detection Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15

Algorithm Version Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17

Filter Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-18

Artifact Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-18

AC Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-19

Frequency Response Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-19

Baseline Wander Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20

Speed and Sensitivity Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21

Device Identification Number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21

12-Lead ECG Report Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-22

15 and 16-Lead ECG Report Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-29

ST Map Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-34

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12-Lead ST Map Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34

Extended Lead ST Map Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34

Rhythm Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-39

1-Minute Disclose Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-42

Extended Measurements Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-43

Chapter 5 Cardiograph Care and Maintenance

Cardiograph and PIM Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Approved Cleaning Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Patient Data Cable and Lead Wire Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Approved Cleaning Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Reusable Electrode Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Cleaning the Print Head . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

Printer Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Battery Maintenance and Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8

Replacing the Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

Battery Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Patient Interface Module (PIM) Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14

Ping Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14

Lead Wire Performance Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

Cardiograph and Accessory Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

Maintaining the Touch Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16

Touch Screen Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16

Touch Screen Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16

Changing the Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16

Replacing the PageWriter TC50 Cardiograph Fuse. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17

Appendix A Suppressed Borderline Interpretive Statements

Philips 12-Lead Algorithm Version PH090A

Exclude Low Certainty Suppressed Statements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

Philips 12-Lead Algorithm Version PH090A

Exclude All Suppressed Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

Philips DXL ECG Algorithm Version PH100B

Exclude Low Certainty Suppressed Statements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6

Philips DXL ECG Algorithm Version PH100B

Exclude All Suppressed Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8

Appendix B Critical Value Statements

Philips 12-Lead Algorithm Version PH090A

Acute Myocardial Infarction Critical Value Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2

Philips 12-Lead Algorithm Version PH090A

Tachycardia Critical Value Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4

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Philips 12-Lead Algorithm Version PH090A

Complete Heart Block Critical Value Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4

Philips DXL ECG Algorithm Version PH100B

Acute Myocardial Infarction Critical Value Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5

Philips DXL ECG Algorithm Version PH100B

Tachycardia Critical Value Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-7

Philips DXL ECG Algorithm Version PH100B

Complete Heart Block Critical Value Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-7

Philips DXL ECG Algorithm Version PH100B

Acute Ischemia Critical Value Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-8

Appendix C Specifications

Technical Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

ECG Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

PageWriter TC70 Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

PageWriter TC50 Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

PageWriter TC70 Touchscreen Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

PageWriter TC50 Touchscreen Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

Patient Interface Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

Patient Interface Module Signal Acquisition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2

Signal Processing/Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2

Sampling Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2

Auto Frequency Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2

Rhythm Frequency Response. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2

Minimum Amplitude or Value of Patient Physiological Signal . . . . . . . . . . . . . . . . . . . . . C-2

Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2

Printer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2

Printer Resolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2

Report Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

Exam Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

12 Lead Report Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

16 Lead Report Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

Rhythm Report Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

Battery Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

Voltage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

PageWriter TC70/TC50 Two Battery Operating Capacity . . . . . . . . . . . . . . . . . . . C-4

PageWriter TC50 One Battery Operating Capacity . . . . . . . . . . . . . . . . . . . . . . . . C-4

Status Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-4

Recharge. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-4

Network Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-4

FAX Capability (optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-4

Modem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-4

Barcode Reader (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-4

Magnetic Card Reader (optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5

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Smart Card Reader (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5

ECG Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5

Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5

ECG File Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5

Power and Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5

PageWriter TC70 Cardiograph AC Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5

PageWriter TC50 Cardiograph AC Input Voltage . . . . . . . . . . . . . . . . . . . . . . . . . . C-5

PageWriter TC50 Cardiograph AC Output Voltage . . . . . . . . . . . . . . . . . . . . . . . . C-5

PageWriter TC70 Cardiograph Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6

PageWriter TC70 Cardiograph Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6

PageWriter TC50 Cardiograph Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6

PageWriter TC50 Cardiograph Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-7

Safety and Performance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-7

Classification (IEC 60601-1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-7

PageWriter TC50 Cardiograph Class I (Internally Powered). . . . . . . . . . . . . . . . . . C-7

PageWriter TC70 Cardiograph Class II (Internally Powered) . . . . . . . . . . . . . . . . . C-7

Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-8

Reducing Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-9

Wireless LAN Card Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-14

Summit SDC-CF20G Wireless Adapter (Option D21). . . . . . . . . . . . . . . . . . . . . . . . . C-14

Summit SDC-CF22AG Wireless Adapter (Option D22) . . . . . . . . . . . . . . . . . . . . . . . C-18

Index

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Contents-8 PageWriter TC70/TC50 Cardiograph Instructions for Use

Page 11

1About the PageWriter TC70 and

PageWriter TC50 Cardiographs

About the Instructions for Use

This PageWriter TC70 and PageWriter TC50 Cardiograp h Instructions for Use is intended to assist users in the safe and effective use of the product.

Before attempting to operate this product, read this Instructions for Use, and note and strictly observe all Warning and Cautions as described in this document.

Pay special attention to all of the safety information provided in the Safety Summary section. For more information, see page i-i.

WARNING Warning statements describe conditions or actions that may result in a potentially

serious outcome, adverse event, or a safety hazard. Failure to follow a Warning may result in death or serious injury to the user or to the patient.

CAUTION Caution statements describe when special care is necessary for the safe and effective use of the

product. Failure to follow a caution may result in minor to moderate personal injury or damage to the product or other property, a remote risk of more serious injury, or may cause environmental pollution.

NOTE Notes contain additional important information about a topic.

TIP A Tip contains suggested information on using a particular feature.

Menu items and button names appear in bold no-serif font. Example: Touch the Setup button.

Safety Summary

Symbols Marked on the Cardiograph or Patient Interface Module (PIM)

Symbol Name Description

Attention; read the Instructions for Use

Type CF

Defibrillator Proof

DC Polarity Indicates the polarity of the DC power connector.

See the PageWriter TC70 and PageWriter TC50 Cardiograph Instructions for Use.

ECG physio isolation is type CF, defibrillator proof. Suitable for all patient applications including direct cardiac application. System is in continuous operation.

i-i

Page 12

Safety Summary Symbols Marked on the Cardiograph or Patient Interface Module (PIM)

Symbols Marked on the Cardiograph or Patient Interface Module (PIM)

Symbol Name Description

Direct Current Indicates that the equipment is suitable for direct

current only.

Disposal Dispose of in accordance with the requirements of

your country.

ECG output signal The connector near this symbol provides access to an

analog ECG signal that can be used as a synchronization signal for external devices, such as an imaging device. This analog ECG signal is not diagnostic quality and should not be used for ECG analysis purposes.

Local Area Network (LAN) Connector

Connect the Ethernet RJ45 LAN cable to the connector directly above this symbol to establish LAN connectivity.

Modem Connector Connect an analog phone line to the connector d irectly

above this symbol.

Attention; read the Instructions for Use

Patient Interface Module (PIM) Connector

See the PageWriter TC70 and PageWriter TC50 Cardiograph Instructions for Use.

Connect the PIM patient data cable to the connector located directly above this symbol.

PCMCIA icon Insert the wireless LAN card into the slot located

directly above this symbol.

PS/2 Connector Connect the Magnetic Card Reader or Barcode Reader

to the connector located directly above this symbol.

Serial Number The number next to this symbol is the serial number of

the cardiograph.

Standby Pressing the button with this symbol on it puts the

cardiograph into Standby (power saving mode).

i-ii PageWriter TC50/TC70 Cardiograph Instructions for Use

Page 13

Symbols Marked on the Cardiograph or Patient Interface Module (PIM) Safety Summary

Symbols Marked on the Cardiograph or Patient Interface Module (PIM)

Symbol Name Description

USB Connector The connector near this symbol is used with a USB

device.

Non-ionizing electromagnetic radiation

Interference may occur in the vicinity of equipment marked with this symbol.

Equipotential Grounding Post Equipotential grounding post used for establishing

common ground between instruments.

Class II Protection against electric shock (PageWriter TC70

Cardiograph only).

Fuse The PageWriter TC50 Cardiograph contains a 1 .6 amp

(250V) time-delay fuse.

PageWriter TC50/TC70 Cardiograph Instructions for Use i-iii

Page 14

Safety Summary Safety Symbols Marked on the Cardiograph Packaging

Safety Symbols Marked on the Cardiograph Packaging

Symbol Description

Keep dry.

Ambient temperature range of -20 transport and storage.

Note: the batteries will discharge at a rapid rate if the cardiograph is stored at a high temperature.

Atmospheric pressure range of 0 to 4572 meters (15,000 feet), 572 hPA above sea level for transport and storage.

C (-4o F) to 50 oC (122o F) (non-condensing) for

Relative humidity range of 10% to 90% (non-condensing) for transport and storage.

Made from recycled materials.

Fragile.

Lithium ion battery. Do not dispose of in trash. Follow local regulations for disposing of as small chemical waste.

This product consists of devices that may contain mercury, which must be recycled or disposed of in accordance with local, state, or federal laws. (Within this system, the backlight lamps in the monitor display contain mercury.)

Dispose of in accordance with the requirements of your country.

i-iv PageWriter TC50/TC70 Cardiograph Instructions for Use

Page 15

Safety and Regulatory Symbols Marked on the PageWriter TC70 Cardiograph Cart Safety Summary

Safety and Regulatory Symbols Marked on the PageWriter TC70 Cardiograph Cart

Symbol Name Description

Cart Transport Do not transport the cart with the drawer open.

Cart Drawer Weight Limit

Cart Storage Bin Weight Limit

Do not place more than 3 kilograms or 6.6 pounds of weight into the cart drawer.

Do not place more than 3 kilograms or 6.6 pounds of weight into the cart storage bin.

Safety and Regulatory Symbols Marked on the PageWriter TC50 Cardiograph Cart

Symbol Name Description

Cart Storage Bin Weight Limit

Do not place more than 3 kilograms or 6.6 pounds of weight into the cart storage bin.

Optional Patient Cable Arm

PageWriter TC50/TC70 Cardiograph Instructions for Use i-v

Do not transport the cart with the patient cable arm positioned to the side. Only transport the cart with the patient cable arm positioned to the front of the cart.

Page 16

Safety Summary Safety and Regulatory Symbols Marked on the PageWriter TC70 Cardiograph AC Power Adapter

Safety and Regulatory Symbols Marked on the PageWriter TC70 Cardiograph AC Power Adapter

Symbol Name Description

No serviceable parts inside

Indoor, dry location use only

Attention; read the Instructions for Use

There are no serviceable parts inside the AC adapter. Do not open the AC adapter case.

The AC adapter is only intended for indoor use in a dry location.

See the PageWriter TC70 and PageWriter TC50 Cardiograph Instructions for Use for information on the AC power adapter.

AC adapter disposal Dispose of in accordance with the requirements

of your country.

i-vi PageWriter TC50/TC70 Cardiograph Instructions for Use

Page 17

Accessories and Supplies Important Patient and Safety Information

Important Patient and Safety Information

The PageWriter TC70 cardiograph and PageWriter TC50 cardiograph isolate all connections to the patient from electrical ground and all other conductive circuits in the cardiograph. This reduces the possibility of hazardous currents passing from the cardiograph through the patient’s heart to ground.

WARNING Failure to follow these warnings could affect both patient and operator safety.

Accessories and Supplies

WARNING Always clean and disinfect reusable electrodes before patient use. Failure to properly

clean and disinfect reusable electrodes before patient use may cause infectious materials to be transferred between patients.

WARNING The Welsh bulb electrodes (available as an accessory for the cardiograph) do not meet

the requirements of IEC 60601-2-25 for defibrillation recovery time, and cannot be reliably used for patient diagnosis immediately following defibrillation.

WARNING When using additional peripheral equipment powered from an electrical source other

than the cardiograph, the combination is considered to be a medical system. It is the responsibility of the operator to comply with IEC 60601-1-1 and test the medical system according to the requirements. For additional information contact Philips Medical Systems.

WARNING Do not use non-medical peripherals within 6 feet of a patient unless the non-medical

peripherals receive power from the cardiograph or from an isolation transformer that meets medical safety standards.

CAUTION The Welsh bulb electrodes contain natural rubber latex which may cause allergic reactions.

CAUTION The use of equipment that applies high frequency voltages to the patient (including electrosurgical

equipment and some respiration transducers) is not supported and may produce undesired results.

CAUTION Only use Philips Medical Systems replacement parts and supplies with the cardiograph. The use of non-

approved replacement parts and supplies with the cardiograph is strictly prohibited. Cardiograph safety and performance are not guaranteed when non-approved replacement parts and supplies are used with the cardiograph.

PageWriter TC50/TC70 Cardiograph Instructions for Use i-vii

Page 18

Important Patient and Safety Information AC Power Adapter and AC Power Cord

 Using accessories, peripherals, or cables that are not supplied with the cardiograph or that

are not recommended by Philips Medical Systems can result in increased emissions or decreased immunity of the cardiograph.

 Connect other equipment in accordance with IEC 60601-1-1 Medical Electrical Systems

Standard or IEC 60601-1: 2005 (3rd Edition) Medical Electrical Equipment Standard Clause 16 Medical Electrical Systems.

 When connecting the cardiograph to other AC powered equipmen t, only connect e quipment

approved to IEC 60601-1 Medical Electrical Equipment or IEC 60950-1 Information Technology Equipment.

 Only use patient electrodes that are approved by Philips Medical Systems. The use of non-

approved patient electrodes may degrade cardiograph performance.

 T o prevent burns to the pat ient, remove all ECG electrodes and lead wires prior to the use of

high frequency surgical equipment (including electrosurgical equipment and some respiration transducers).

AC Power Adapter and AC Power Cord

WARNING Only use the external power supply with part number 453564094411 with the

PageWriter TC70 cardiograph in order to prevent electrical safety hazards. The use of any other power supply is not approved by Philips Medical Systems.

WARNING Whenever the AC power cord is connected to a live power outlet, ensure that it is also

securely attached to the cardiograph. Always disconnect the AC power cord from the power outlet when it is not connected to the cardiograph.

WARNING Only use grounded power cords (three-wire power cords with grounded plugs) and

grounded electrical outlets that are labeled as Hospital Only or Hospital Grade. NEVER adapt a grounded plug to fit an ungrounded outlet by removing the ground prong. Use the equipotential post when redundant earth ground is necessary according to IEC 60601-1-

CAUTION The power supply could feel warm to the touch.

 .The PageWriter TC70 cardiograph external po wer supply, part number 453564094411, is

designed with a three wire supply system. The ground only serves a functional purpose for EMC and not protective earth for electrical safety. Use of an appropriate three-wire power cord is necessary to provide proper EMC operation.

i-viii PageWriter TC50/TC70 Cardiograph Instructions for Use

Page 19

Analog ECG Output Signal Port Important Patient and Safety Information

 Only use the AC power adapter designed to be used with the PageWriter TC70 cardiograph,

part number 453564094411 , in order to ensure continue d compliance with the requirements of IEC 60601-1.

 To disconnect the cardiograph from AC power, unplug the cardiograph AC power cord

from the mains power supply.

 This equipment complies with the earth leakage current limits as specified in UL 60601-

1:2003 Medical Electrical Equipment - General Requirements for Safety, only when connected to a 120 Volt mains power supply.

 Periodically inspect the patient data cable, lead wires, and AC power cord for any worn or

cracked insulation. Ensure that no exposed wires are visible on the AC power cord.

 Only use the Philips Medical Systems AC power cord (part number 453564094411)

supplied with the cardiograph. Use of any other power supply has not been verified and may lead to operator or patient harm, including electrical shock. Periodically inspect the AC power cord and AC power connector to ensure that both are in a safe and operable condition. If the AC power cord or AC power connector is not in a safe or operable condition, operate the cardiograph on battery power and contact Philips Medical Systems for service.

Analog ECG Output Signal Port

 Do not use the analog ECG output signal port (not supported on cardio graph) for diagno stic

purposes and do not use this signal for critical synchronization timing.

 Do not connect any equipment to the cardiograph analog ECG output signal port that does

not meet medical safety requirements and that has not been evaluated by local safety personnel.

Batteries

CAUTIONS  Before removing and replacing batteries from the cardiograph, press down and hold the On/

Standby button ( ) (located on the front of the cardiograph), to shut down the cardiograph. Ensure that the cardiograph is shut down. When the cardiograph is fully shut down, the screen is black, and the On/Standby button is not illuminated. Once the cardiograph is shut down, proceed to remove and replace the batteries.

 When removing batteries from the cardiograph, the batteries could feel warm to the touch.

 The battery capacity for the PageWriter TC50 cardiograph with a single battery installed

using the battery with Philips part number 989803170371, is 30 minutes of continuous Rhythm printing, or 30 total ECG reports.

 When operating the PageWriter TC50 cardiograph with one battery installed, only use the

Philips battery with part number 989803170371. Do not use the battery with Philips part number 989803160981 for one battery operation.

 When operating the PageWriter TC70 or the PageWriter TC50 cardiograph with two

batteries installed, ensure that both batteries contain the same Philips part number. The

PageWriter TC50/TC70 Cardiograph Instructions for Use i-ix

Page 20

Important Patient and Safety Information PageWriter TC50 Cardiograph One Battery Operation

battery part number identification label is found on the bottom of the battery. The cardiograph cannot operate with two batteries that contain different part numbers. If the cardiograph is operated with two batteries with different part numbers, the cardiograph will display an error message and will not operate.

PageWriter TC50 Cardiograph One Battery Operation

 The PageWriter TC50 cardiograph with inst alled software version A.04.00 and h igher can

operate on a single battery with Philips part number 989803170371.

 The battery capacity for the PageWriter TC50 cardiograph with a single battery installed

using the battery with Philips part number 989803170371, is 30 minutes of continuous Rhythm printing, or 30 total ECG reports.

 When operating the PageW riter TC50 cardiograph with one battery installed, only use the

Philips battery with part number 989803170371. Do not use the battery with Philips part number 989803160981 for one battery operation.

 When operating the PageWriter TC50 cardiograph with one battery installed, the single

battery may be inserted into either battery compartment.

Cart

 Ensure that the cardiograph is securely attached to the cardiograph cart before use.

Defibrillation

WARNING Do not touch the patient, patient data cable, leads, or the cardiograph during

defibrillation. Death or injury may occur from the electrical shock delivered by the defibrillator.

Diagrams

 Upon customer request, Philips Medical Systems will make available circuit diagrams,

component part lists, descriptions, calibration instructions and other technical information.

Display Accuracy

 The accuracy of the ECG signals are within +/- 5% (or +/- 40 uV whichever is greater), over

a range of 0 to 5 mV, in the presence of differential and common mode DC offset voltages of +/- 300 mV. The cardiograph performance is tested to comply with the accuracy requirements over the dynamic ranges and frequency ranges specified in the IEC 60601-251 and AAMI EC-11 standards.

 For additional details regarding accuracy and precision, refer to the Physician's Guide and

the Manufacturer's Disclosure Statement.

i-x PageWriter TC50/TC70 Cardiograph Instructions for Use

Page 21

ECG Interpretation Important Patient and Safety Information

ECG Interpretation

CAUTION Always enter accurate patient information (including age and gender) if using the Philips DXL ECG

Algorithm or Philips 12-Lead Algorithm for ECG interpretation.

Electrodes

 Philips recommends the use of disp osable elec trodes at all times for all patient applications.

Choose either adult or pediatric disposable electrodes based on the age and size of the patient. See “Disposable and Reusable Electrodes” on page 1-48 for information on ordering disposable electrodes.

Faxed ECGs

CAUTION No guarantee is made as to the suitability of a faxed ECG for any particular purpose, due to the

variability inherent in fax technology.

CAUTION Faxed ECGs should only be sent to secure recipient fax machines.

General Cardiograph Use

WARNING Electrical shock hazard. Keep the cardiograph, Patient Interface Module (PIM), and all

cardiograph accessories away from liquids. Do not immerse the cardiograph, PIM, or other accessories in any liquids.

WARNING Do not use this cardiograph near flammable anesthetics. It is not intended for use in

explosive environments or in operating rooms. The disconnection or connection of AC power, or electrostatic discharge (ESD) may result in an electrical spark.

CAUTION The cardiograph may generate electromagnetic interference (EMI) that may cause nearby equipment

to fail.

CAUTION The use of equipment that applies high frequency voltages to the patient (including electrosurgical

equipment and some respiration transducers) is not supported and may produce undesired results. Disconnect the patient data cable from the cardiograph, or detach the leads from the patient prior to performing any procedure that uses high frequency surgical equipment.

PageWriter TC50/TC70 Cardiograph Instructions for Use i-xi

Page 22

Important Patient and Safety Information IEC 60601-2-51

 The use of non-Philips equipment connected to, or operating with, the PageWriter TC70

cardiograph or the PageWriter TC50 cardiograph is not tested or supported, and may produce undesired results.

 Connecting multiple cardiographs to the same patient may pose a safety hazard due to the

summation of leakage currents. Any combination of instruments should be evaluated by local safety personnel before being put into service.

IEC 60601-2-51

 For information on the standard IEC 60601-2-51, please go to the Philips InCenter web site

(

incenter.medical.philips.com). For information on using the Philips InCenter site, see page 1-

Lead Wires

WARNING Electrical shock hazard. Do not touch accessible connector pins and the patient

simultaneously.

WARNING Do not touch any loose or exposed leads during defibrillation. Death or injury may occur

from the electrical shock delivered by the defibrillator.

WARNING Ensure that the electrodes or lead wires do not come in contact with any other

conductive materials (including earth-grounded materials) especially when connecting or disconnecting electrodes to or from a patient.

Main Waveform Display Screen

 Manual measurements of ECG intervals and magnitudes should be performed on printe d

ECG reports only . Do not make manual measurements of ECG intervals and magnitudes on the main waveform display screen since these ECG representations are scaled.

Modem Card and Fax Feature

WARNING Do not connect the modem card to a phone line when the cardiograph is connected to a

patient.

i-xii PageWriter TC50/TC70 Cardiograph Instructions for Use

Page 23

Pacemaker Important Patient and Safety Information

WARNING Only connect the phone line to the modem connector ( ) located on the rear panel

of the cardiograph. Never attach the phone line to the LAN connector ( ).

 No guarantee is made as to the suitability of a faxed ECG report for any particular purpose,

due to the variability inherent in fax technology.

Pacemaker

 Pace pulses may not be visible on a printed ECG report that uses simultaneous acquisition.

Patient Data Cable

WARNING The Philips Medical Systems patient data cable (supplied with cardiograph) is an integral

part of the cardiograph safety features. Use of any other patient data cable may lead to the distortion or corruption of patient ECG data, may compromise defibrillation protection and degrade cardiograph performance, and overall cardiograph safety may be seriously degraded.

WARNING Ensure that the patient data cable is securely connected to the PIM Connector ( )

on the rear panel of the cardiograph.

 The PageWriter TC50 cardiograph with installed software version A.03.00 and higher are

only compatible with the Class B patient data cable (Philips part number 989803164281).

 Keep the patient data cable away from power cords and any other electrical equipment.

Failure to do so can result in AC power line frequency interference on the ECG trace.

 Periodically inspect the patient data cable for any cracks or breaks in the cable insulation. If

the integrity of the patient data cable is not assured, replace the patient data cable. Contact Philips Medical Systems for further assistance, see "Contacting a Philips Response Center" on page 1-51.

Patient Interface Module (PIM)

WARNING Always clean and disinfect the Patient Interface Module (PIM) after patient use, if the

PIM comes into direct contact with the patient’s skin. Failure to properly clean and disinfect the PIM after direct contact with the patient’s skin may cause infectious materials to be transferred between patients.

PageWriter TC50/TC70 Cardiograph Instructions for Use i-xiii

Page 24

Important Patient and Safety Information Printer

CAUTION If using the optional, 16-lead PIM, always ensure that the leads connected to the Patient Interface

Module (PIM) are the same leads that are displayed on the cardiograph screen.

 The PageWriter TC50 cardiograph with installed software version A.03.00 and higher is

only compatible with the Class B 12-lead PIM (Philips part number 453564150741, AAMI and 453564150761, IEC) or the Class B 16-lead PIM (Philips part number 453564150751, AAMI and 453564150771, IEC).

 Always put the cardiograph in Standby before replacing the Patient Interface Module

(PIM). Do not change the PIM while the cardiograph is in active use.

Printer

CAUTION Do not pull on the paper while an ECG report is being printed. This can cause distortion of the

waveform and can lead to potential misdiagnosis.

Servicing the Cardiograph

 Only qualified personnel may service the cardiograph or may open the cardiograph housing

to access internal cardiograph components. Do not open any covers on the cardiograph. There are no internal cardiograph components that are serviced by the operator.

 The Philips Medical Systems warranty is applicable only if you use Philips Medical

Systems approved accessories and replacement parts. See “Supplies and Ordering Information” on page 1-45 for more information.

Software

WARNING Only install Philips Medical Systems software on the cardiograph. The installation or use

of software not approved by Philips Medical Systems is strictly prohibited and cardiograph safety and performance are not guaranteed.

Touch Screen

WARNING Do not use sharp objects with the touch screen or apply excessive force to the touch

screen. Applying excessive force to the touch screen may result in breaking the touch screen display and can cause sharp, jagged parts to expel to persons nearby.

 Manual measurements of ECG intervals and magnitudes should be performed on printe d

ECG reports only . Do not make manual measurements of ECG intervals and magnitudes on the touchscreen display since these ECG representations are scaled.

i-xiv PageWriter TC50/TC70 Cardiograph Instructions for Use

Page 25

USB Memory Stick The PageWriter TC70 Cardiograph and PageWriter TC50 Cardiograph

USB Memory Stick

WARNING Do not use the USB memory stick to import ECGs from other cardiographs, or other

non-Philips devices onto the PageWriter TC70 cardiograph or PageWriter TC50 cardiograph.

CAUTIONS Only use the USB memory stick that is available for purchase as an optional accessory from Philips

Medical Systems with the PageWriter TC cardiograph.

Do not insert a USB memory stick into the cardiograph, or remove a USB memory stick from the cardiograph when the cardiograph is acquiring ECG data from the patient.

Only use the USB memory stick to transfer data between the cardiograph and a computer. Do not use the USB memory stick with other devices.

Keep all USB memory sticks that contain patient data in a secure location where they cannot be accessed by unauthorized personnel. Always delete patient data from a USB memory stick promptly after use.

Affix a label to all USB memory sticks that contain patient data notifying users that unauthorized access of patient data on the USB memory stick is punishable by law.

 Periodically inspect the USB connectors (side and rear of cardiograph) for any cracks or

breaks. If the integrity of a USB connectors is not assured, do not use the USB connector, and contact Philips Medical Systems for further assistance, see "Contacting a Philips Response Center" on page 1-51.

The PageWriter TC70 Cardiograph and PageWriter TC50 Cardiograph

These Philips products are intended to be used and operated only in accordance with the safety procedures and operating instructions provided in this Instructions for Use, and for the purposes for which it was designed. The purposes for which the product is intended are provided below. However, nothing stated in this Instructions for Use reduces the responsibility of the user for sound clinical judgment and best clinical procedures.

Intended Use

The intended use of the cardiograph is to acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes and to record, display, analyze, and store these ECG signals for review by the user. The cardiograph is to be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished with algorithms that provide measurements, data presentations, graphical presentations, and interpretations for review by the user.

The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings.

PageWriter TC50/TC70 Cardiograph Instructions for Use i-xv

Page 26

The Philips ECG Algorithm Indications for Use

A qualified physician is asked to overread and validate (or change) the computer-generated ECG interpretation.

Indications for Use

The cardiograph is to be used where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment, or to rule out causes for symptoms.

The Philips ECG Algorithm

The PageWriter TC70 cardiograph and PageWriter TC50 cardiograph software uses the Philips ECG Algorithm. The algorithm in the software analyzes the morphology and rhythm on each of the 16 leads and summarizes the results. The set of summarized measurements is then analyzed by the clinically-proven ECG Analysis Program.

16-lead reports may include or exclude ECG measurements, reasons, or analysis statements.

Intended Use

The intended use of the Philips ECG Algorithm is to analyze multi-channel ECG signals from adult and pediatric patients with algorithms that provide measurements, data presentations, graphical presentations, and interpretations for review by the user.

Indications for Use

The Philips ECG Algorithm is to be used where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment, or to rule out causes for symptoms.

i-xvi PageWriter TC50/TC70 Cardiograph Instructions for Use

Page 27

1Getting Started

Welcome to the PageWriter TC70 and TC50 cardiographs, a versatile and powerful addition to your cardiac care patient workflow. The PageWriter TC cardiographs help to simplify patient cardiac care through easy-to-use 1-2-3 touch screen operation, color-coded signal quality indicators, and integrated connectivity with the TraceMaster ECG Management System for one touch patient order download and ECG transmission. The PageWriter TC70 and TC50 cardiographs also support integrated connectivity with an ADT Order Update system. Powerful clinical features include the Philips DXL ECG Algorithm that provides comprehensive measurement and interpretive analysis for up to 16 leads, and includes full pediatric interpretation, enhanced pacemaker pulse detection, lead reversal detection notification, and the Critical Values feature that provides an alert to caregivers of a silent MI or other conditions that require immediate treatment, an integral tool for acute care environments. Other time-sensitive clinical tools include ST Map reports that indicate ST elevation, along with optional culprit artery identification that locates the probable anatomical site of a coronary artery occlusion responsible for an ischemia. Support for up to 16 leads assists in the precise detection of right sided or posterior myocardial injury in adults, conditions that are difficult to diagnosis or detect in standard 12-lead ECGs. For pediatric patients, the use of 15 leads provides full information on the electrical activity of the right ventricle of the heart, crucial information for the accurate diagnosis of pediatric patients.

This PageWriter TC70 and PageWriter TC50 Cardiograph Inst ruct ions for Use and the other components provided in the Learning Kit describe all aspects of setting up, using, and maintaining your cardiograph.

NOTE Read and complete the materials included in the PageWriter TC70/TC50 Cardiograph Learning Kit

before using the cardiograph. Pay close attention to all warnings and cautions.

1-1

Page 28

Getting Started PageWriter TC70/TC50 Cardiograph Learning Kit

PageWriter TC70/TC50 Cardiograph Learning Kit

Philips Medical Systems provides detailed instructional and reference materials in the PageWriter TC70/TC50 Cardiograph Learning Kit.

The PageWriter TC70/TC50 Cardiograph Learning Kit contains the Quick Help Guide, User Skills Checklists, and the User Documentation and Training DVD.

Figure 1-1 The PageWriter TC70/TC50 Cardiograph Learning Kit

About the PageWriter TC70/TC50 Cardiograph Learning Kit

 Getting Started Guide (A)

This fold out guide Guide provides out-of-the-box instructions for setting up the cardiograph. It is intended to be used with the instructions provided in this chapter.

1-2 PageWriter TC70/TC50 Cardiograph Instructions for Use

Page 29

Getting Started PageWriter TC70/TC50 Cardiograph Learning Kit

 User Documentation and Training DVD (B)

The user documentation and training DVD includes many useful files including: – Philips DXL ECG Algorithm Physician’s Guide

This Physician’s Guide provides a comprehensive description of the Philips DXL ECG Algorithm version PH100B, and lists all of the interpretive statements included in the 0B criteria.

– Philips 12-Lead Algorithm Physician’s Guide

This Physician’s Guide provides a comprehensive description of the Philips 12-Lead Algorithm version PH090A, and lists all of the interpretive statements included in the 0A criteria.

– PageWriter TC Cardiograph Network Configuration Guide (only available in

English)

This Network Configuration Guide provides detailed instructions on installing and configuring wired or wireless network connectivity between the cardiograph and the TraceMaster ECG Management System (including the OrderVue order handling option), or other third party ECG management system.

– PageWriter TC Cardiograph Service Manual (only available in English)

This document provides comprehensive information on product troubleshooting, performance verification and safety tests, using the Service Utilities accessed from the Setup menu, and installing software upgrades.

– Metrologic Scanner Instructions for Use (only available in English)

This document provides comprehensive information on using and configuring the optional barcode scanner available with the cardiograph, and also provides detailed calibration sequences for configuring the barcode scanner for use with extended Code 39 barcode standards.

– PageWriter TC70 and PageWriter TC50 Cardiograph Interactive Training Program

for software version A.02.00 (only available in English)

This training program provides detailed information on the purpose of 12 and 16-lead ECGs, the different views of the heart that the ECG represents, electrode placement for 12 or 16 leads, effective patient preparation, basic cardiograph operation, and how to troubleshoot various ECG signal quality problems. The training program also includes interactive, hands-on training exercises to test users on information provided in the training program. Updates to this training program will be available on a periodic basis, and may be downloaded from the Philips InCenter site. For more information on accessing and using the Philips InCenter site, see “Using the Philips InCenter Site" on page 1-5.

To open the User Documentation and Training DVD:

Insert the DVD into a DVD-compatible drive on a standard PC. The main menu opens automatically. Click on a blue button or on the file name to

open a file.

NOTE If you save PDF files from the DVD to a PC hard drive, Acrobat Reader 9.0 will need to be

installed on the PC in order to view the files. For a free install, go to: www.adobe.com.

If the main menu does not automatically appear, open the DVD in W indows Explorer.

PageWriter TC70/TC50 Cardiograph Instructions for Use 1-3

Page 30

Getting Started Philips ECG XML Information

3 Double-click the file menu.pdf on the DVD. The main menu appears. Any of the files

on the DVD may be printed or saved to a PC hard drive

 User Skills Checklists (C) (only available in English)

These checklists provide a comprehensive list of all of the tasks associated with patient preparation, taking an ECG, and using the cardiograph features. These checklists provide the basis for all critical tasks recommended for inclusion in a clinical training program. These checklists can be copied as necessary, and retained as an official record of clinical training at your facility. The checklists are also included as PDF files on the User Documentation and Training DVD.

 Quick Help Guide (D)

The Quick Help Guide is presented as an easy-to-use flip book that can be left at the cardiograph in order to provide clear and simple instructions to users on using cardio graph features. Included are instructions on proper patient preparation and electrode placement, signal quality indicators, taking STAT or urgent ECGs, how to retrieve orders, and using other cardiograph features. The guide is included as a PDF file on the User Documentation and Training DVD, and additional copies may be printed if necessary. The PDF file is sized appropriately for printing on standard sized paper.

Philips ECG XML Information

The PageWriter TC70 cardiograph and PageWriter TC50 cardiograph export ECG data in XML (Extensible Markup Language) format. There are th ree avai lable XML sch ema versio ns on the cardiograph: version 1.03, version 1.04, and version 1.04.01. Version 1.03 exports E CG data in 12-lead format only, version 1.04 exports ECG data for up to 16 leads, and version

1.04.01 exports ECG data for up to 16 leads and includes full interpretation from the Philips DXL Algorithm.

Information regarding the Philips ECG XML schema can be obtained directly from Philips Medical Systems by sending an email request to: name, facility, and the serial number of your PageWriter TC cardiograph in the email request.

NOTE The default XML version setting on the cardiograph must be coordinated with the XML version

compatibility of the TraceMaster ECG Management System, or other third party ECG management system used by your facility. For more information on configuring your cardiograph for use with an external ECG management system, see the PageWriter TC Network Configuration Guide included on the User Documentation and Training DVD, or download the file from the Philips InCenter site.

ecg@philips.com. Please include your

1-4 PageWriter TC70/TC50 Cardiograph Instructions for Use

Page 31

Getting Started Using the Philips InCenter Site

Using the Philips InCenter Site

The Philips InCenter site provides frequent updates to all Philips Cardiac Systems product documentation and product software, including the PageWriter TC70 and PageWriter TC50 cardiographs.

The Philips InCenter site requires an active registration and password. To register, go to the InCenter site at: (located under the user login and password fields). On the following page, under

Updates

Cardiac Systems InCenter Registration page appears. Complete all of the information fields on the page to receive a login and password for the InCenter site.

Registration for the InCenter site requires the serial number of at least one PageWriter TC70 or PageWriter TC50 cardiograph in active use at your facility. The serial number is found on the product identification label. The product identification label is located on the rear panel of the cardiograph.

(lower right corner of page), click the Click here for account registration link. The

About Adobe Acrobat Versions

Adobe Acrobat Reader version 9.0 must be installed on the PC that is used to access the Philips InCenter site. Previous versions of Acrobat Reader are not compatible with the Philips InCenter site, and attempting to access InCenter with a previous version of Acrobat Reader will result in error messages when opening documents. Uninstall all previous versions of Acrobat Reader, and then proceed for a free install of Acrobat Reader 9.0 at:

incenter.medical.philips.com and click on the Need help? link on the main page

Software

www.adobe.com.

Any version of Adobe Acrobat Professional or Acrobat Elements are also not compatible with the Philips InCenter site, and error messages will appear when opening documents with these applications. Acrobat Reader 9.0 must be installed in addition to Acrobat Professional or Acrobat Elements.

Follow this procedure when accessing documents on the Philips InCenter site.

To access documents on the Philips InCenter site:

Exit Acrobat Professional or Acrobat Elements (if open).

2 Start Acrobat Reader 9.0. 3 Open Internet Explorer , and go to the Philips InCenter site. Keep Acrobat Reader 9.0 open

the entire time while accessing the InCenter site.

PageWriter TC70 Cardiograph Components

The following sections include a description of all of the components of the PageWriter TC70 cardiograph, including the connection ports on the cardiograph, the Patient Interface Module (PIM), and optional accessories available with the cardiograph. For more information on using the cardiograph features, see “The Patient Session" on page 3-1. For information on ordering any of the optional accessories for the cardiograph, see “Supplies and Ordering Information" on page 1-45.

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Getting Started PageWriter TC70 Cardiograph Components

DECF

Figure 1-2 PageWriter TC70 Cardiograph (left front view)

A Touch screen F ECG button B Audio speaker G Paper tray C AC power on indicator light H Keyboard D Power/Standby button E ID button

1-6 PageWriter TC70/TC50 Cardiograph Instructions for Use

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Getting Started PageWriter TC70 Cardiograph Components

Figure 1-3 PageWriter TC70 Cardiograph (right front view)

I Battery compartment J USB memory stick connector

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Getting Started PageWriter TC70 Cardiograph Components

Figure 1-4 PageWriter TC70 Cardiograph (rear view)

A Modem connector G Wireless LAN card slot (with protective

cover installed)

B LAN connector H AC power connector C Barcode reader or magnetic card reader

connector

D Analog ECG output signal connecto r (not

supported)

E USB connector F PIM connector

WARNING Do not connect the modem card to a phone line when the cardiograph is connected to a

patient.

CAUTION Do not insert a USB memory stick into the cardiograph, or remove a USB memory from the

cardiograph when the cardiograph is acquiring ECG data from a patient.

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Getting Started PageWriter TC50 Cardiograph Components

GH I J

PageWriter TC50 Cardiograph Components

The following sections include a description of all of the components of the PageWriter TC50 cardiograph, including the connection ports on the cardiograph, the Patient Interface Module (PIM), and optional accessories available with the cardiograph. For more information on using the cardiograph features, see “The Patient Session" on page 3-1. For information on ordering any of the optional accessories for the cardiograph, see “Supplies and Ordering Information" on page 1-45.

Figure 1-5 PageWriter TC50 Cardiograph (right front view)

A Touch screen F Keyboard B Audio speakers G AC power on indicator light C Battery compartment H Power/Standby button D USB memory stick connector I ID button E Paper tray J ECG button

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Getting Started PageWriter TC50 Cardiograph Components

Figure 1-6 PageWriter TC50 Cardiograph (rear view)

A Wireless LAN card slot (with protective cover

installed)

G Barcode reader or magnetic card reader

connector

B Equipotential grounding post H LAN connector C AC power cord connector I Modem connector D PIM connector E USB connector F Analog ECG output signal connector (not

supported)

WARNING Do not connect the modem card to a phone line when the cardiograph is connected to a

patient.

CAUTIONS Do not insert a USB memory stick into the cardiograph, or remove a USB memory from the

cardiograph when the cardiograph is acquiring ECG data from a patient.

Only use grounded power cords (three-wire power cords with grounded plugs) and grounded electrical outlets that are labelled as Hospital Only or Hospital Grade. Never adapt a grounded plug to fit an ungrounded outlet by removing the ground prong. Use the equipotential post when redundant earth ground is necessary according to IEC 60601-1-1.

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Getting Started Assembling the PageWriter TC70 Cardiograph Cart

Assembling the PageWriter TC70 Cardiograph Cart

The PageWriter TC70 cardiograph is available with an optional cart that includes a locking storage drawer, storage bin, and a built-in holder for the PIM (patient interface module). The instructions in this section describe the unassembled cart option. For information on ordering the cart, see “PageWriter TC70 and PageWriter TC50 Cardiograph Supply Part Numbers" on page 1-46.

To attach the cardiograph to a fully assembled cart, see Step 7 on page 1-13 .

CAUTION Follow the procedure below to ensure that the cardiograph is securely fastened to the cart before

use.

Figure 1-7 TC70 Unassembled Cart Kit Contents

To attach the cardiograph to the cart:

Insert the beam into the cart base.

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Getting Started Assembling the PageWriter TC70 Cardiograph Cart

2 Hold the beam steadily. Turn the cart onto the side to expose the bottom of the cart.

3 Place the ground strap onto the screw end.

4 Attach the bolt screws and tighten using the provided wrench. Ensure that the bolt screws

are tightened to 80-100 in lbs.

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Getting Started Assembling the PageWriter TC70 Cardiograph Cart

5 Turn the cart upright. 6 Attach the top shelf to the beam using the provided bolts and wrench. Tighten the bolts to

80-100 in lbs.

7 Align the rear feet of the cardiograph with the rear locking holes on the cart. Align the

front feet of the cardiograph with the front screw holes on the cart. Lower the cardiograph onto the cart and snap into place.

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Getting Started Assembling the PageWriter TC50 Cardiograph Cart

8 Insert the front screws through the bottom of the base, and tight en .

9 Slide the drawer onto the cart as shown.

Assembling the PageWriter TC50 Cardiograph Cart

The PageWriter TC50 cardiograph is available with an optional cart that includes a storage bin and a built-in holder for the PIM (patient interface module). A second storage bin is available as an optional accessory. The instructions in this section describe the unassembled cart option. For information on ordering the cart, see “PageWriter TC70 and PageWriter TC50 Cardiograph Supply Part Numbers" on page 1-46.

To attach the cardiograph to a fully assembled cart, see Step 10 on page 1-18 .

CAUTION Follow the procedure below to ensure that the cardiograph is securely fastened to the cart before use.

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Getting Started Assembling the PageWriter TC50 Cardiograph Cart

Figure 1-8 Unassembled Cart Kit Contents

To attach the cardiograph to the cart:

Insert the beam into the cart base.

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Getting Started Assembling the PageWriter TC50 Cardiograph Cart

2 Hold the beam steadily. Turn the cart onto the side to expose the bottom of the cart.

3 Place the ground strap onto the screw end.

4 Attach the bolt screws and tighten using the provided wrench. Ensure that the bolt screws

are tightened to 80-100 in lbs.

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Getting Started Assembling the PageWriter TC50 Cardiograph Cart

5 Turn the cart upright. 6 Attach the bin to the beam.

7 Insert the bin dividers as shown.

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Getting Started Assembling the PageWriter TC50 Cardiograph Cart

8 Slide out the tray on the top shelf.

9 Attach the top shelf to the beam using the bolt screws. T ight en the bolts using the p rovided

wrench. Ensure that the bolt screws are tightened to 80-100 in lbs.

10 Align the rear feet of the cardiograph with the rear holes on the cart. Lower the front feet

of the cardiograph into the front holes on the cart and push the cardiograph into place. Ensure that the cardiograph is locked into the slot on the front right of the cart.

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Page 45

Getting Started Using the Cart Wheel Positioners and Brake

11 Insert the screws through the bottom of the base, and tighten.

Using the Cart Wheel Positioners and Brake

Both cart models include one wheel brake and two wheel positioners. Lock the wheel positioners at all times when using the cart. The wheel positioners keep the cart straight when moving forward or backward, or when turning corners. The wheel positioners also help the cart maneuver in tight spaces.

To use the cart wheel positioners and brake:

Align the front wheels so that they are straight. Step on both wheel positioners. Move the cart forward until the wheels lock into position. The cart will move forward or backward in a straight line.

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Page 46

Getting Started Patient Interface Module (PIM)

2 Step on the gray rear wheel brake to lock the cart wheels. The cart will not move. Step on

the wheel brake again to unlock the wheels.

Patient Interface Module (PIM)

The same Patient Interface Module (PIM) is used on both the TC70 and TC50 model cardiographs. The PIM is a hand-held device that connects to the patient data cable. The PIM is available in a standard 12-lead, or an optional 16-lead model. For information on configuring the optional 16-lead PIM, see “Configuring the 16-Lead PIM" on page 1-26.

NOTE Figure 1-9 shows AAMI version PIMs.

Figure 1-9 16-lead (left) and 12-lead (right) Patient Interface Module (PIM)

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Getting Started Patient Interface Module (PIM)

About Class A and Class B Patient Data Cables and PIMs

Prior to August, 2009, PageWriter TC70 cardiographs with installed software version A.02.00 and lower were shipped from Philips Medical Systems with Class A patient data cables and Class A PIMs. All PageWriter TC70 cardiographs and PageWriter TC50 cardiographs with installed software version A.03.00 and higher are shipped from Philips Medical Systems with Class B patient data cables and Class B PIMs.

The only visual difference between a Class A and a Class B PIM or patient data cable is the number of connectors on the PIM, and the number of pins on the PIM connector end of the patient data cable. All Class A devices have 5 connectors/pins on the PIM connector, and on the PIM connector end of the patient data cable. All Class B devices have 8 connectors/pins on the PIM connector, and on the PIM connector end of the patient data cable.

NOTE Both Class A and Class B patient data cables have 5 pins on the connector end that attaches to the

cardiograph.

Class A patient data cables can only be used with a Class A PIM on the PageWriter TC70 cardiograph. Class B patient data cables can only be used with a Class B PIM on either a PageWriter TC70 or a PageWriter TC50 cardiograph. When ordering replacement patient data cables or PIMs from Philips Medical Systems, check the number of connectors on the PIM, and also check the number of pins on the PIM connector end of the patient data cable to ensure that you are ordering the correct Class A or Class B device.

NOTE If you are unable to connect a patient data cable to a PIM connector, check that both devices are

compatible. You cannot connect a Class A patient data cable to a Class B PIM.

Figure 1-10 Class A and Class B Patient Data Cable Connectors

A Class A patient data cable (5 pins) B Class B patient data cable (8 pins)

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Getting Started Patient Interface Module (PIM)

Figure 1-11 Class A and Class B Patient Interface Module (PIM) Connectors

A Class A PIM (5 connectors) B Class B PIM (8 connectors)

Attaching the Patient Data Cable to the PIM and Cardiograph

The patient data cable must be attached to the PIM connector before use. Once attached to the PIM, the patient data cable is then attached to the cardiograph through the appropriate PIM connector on the rear of the cardiograph.

WARNING Ensure that the patient data cable is securely connected to the PIM connector ( )

on the rear panel of the cardiograph.

WARNING The Philips Medical Systems patient data cable (supplied with cardiograph) is an integral

NOTE The PageWriter TC50 cardiograph with installed software version A.03.00 and higher is only

compatible with the Class B patient data cable (Philips part number 989803164281).

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Page 49

Getting Started Patient Interface Module (PIM)

To attach the patient data cable to the PIM and to the cardiograph:

Align the raised dot on the top of the patient data cable connector with the front of the PIM. Insert the patient data cable connector through the metal housing. Push the patient data cable connector firmly into the PIM connector . The connector clicks when it is locked into position.

NOTE If you are unable to connect a patient data cable to a PIM connector, check that both devices are

compatible. You cannot connect a Class A patient data cable to a Class B PIM. For more information, see page 1-21.

Connect the other end of the patient data cable to the PIM connector port ( ) located on the rear panel of the cardiograph. Align the raised circle on the cable connector upright as shown in the figure. Turn the cable connector to the right to lock it into position.

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Getting Started Patient Interface Module (PIM)

3 Drape the patient data cable over the top of the rear handle on the cart to help ensure that

the patient data cable does not drag on the ground.

To disconnect the patient data cable from the PIM:

 Twist the end of the patient cable connector inside the metal housing and pull the

connector out.

Special Note about Patient Interface Module (PIM)

The PIM is an electronic device and can feel warm if placed on bare skin.

CAUTION If the PIM is placed on the patient’s bare skin, always place a sheet or cloth between the PIM and the

patient. If the PIM is left on the patient’s skin for an extended period of time while the cardiograph is being used for monitoring purposes, the PIM could reach a maximum temperature of 46 °C (114.8 °F) in a room environment with a temperature of 40 °C (104 °F).

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Getting Started Patient Interface Module (PIM)

Figure 1-12 Placing PIM on patient’s skin

A Cloth placed between PIM and patient

PIM ECG Button

The PIM has an ECG button that is used to take ECGs from the bedside. For information on connecting the PIM to the patient, or on using the PIM ECG button, see “The Patient Session” on page 3-1.

Figure 1-13 The 16-Lead PIM with ECG button

A PIM ECG button

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Getting Started Patient Interface Module (PIM)

Configuring the 16-Lead PIM

The optional 16-lead PIM may be configured to support up to 16 optional leads for adult and pediatric application. The 16-lead PIM is shipped with four optional leads, color clip identifiers, and shorting plugs. For information on ordering the 16-lead PIM option, see “PageWriter TC70 and PageWriter TC50 Cardiograph Supply Part Numbers” on page 1-46.

CAUTION When using the 16-lead PIM, always ensure that the leads connected to the Patient Interface Module

(PIM) are the same leads that are displayed on the cardiograph screen.

Figure 1-14 16-Lead PIM Kit

A Color identification clips C Lead separator B Optional leads (4 total) D Shorting plug (6 total)

To configure the 16-lead PIM:

Press the On/Standby button to put the cardiograph into Standby.

CAUTION Always put the cardiograph in Standby before connecting or disconnecting the Patient Interface

Module (PIM). Do not disconnect or connect the PIM to the cardiograph while the cardiograph is in active use.

2 Disconnect the PIM from the cardiograph, if necessary.

3 There are six optional lead connectors available on the PIM. These optional lead

connectors include:

C3R/V3R, C4R/V4R, C5R/V5R, C7/V7, C8/V8 and C9/V9. Any of

these optional leads (up to a maximum of four) may be configured for use with the cardiograph.

NOTE The cardiograph does not support the configuration of 18 leads. Any of the optional leads, up to a

maximum of 4, may be configured for use with the cardiograph.

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Getting Started Patient Interface Module (PIM)

Figure 1-15 16-Lead PIM Optional Lead Connectors (AAMI/IEC)

A Optional lead connectors

Attach the appropriate color-coded identification clip (included in the lead kit) to the lead,

and attach the small color clip near the connector end of the lead wire.

Figure 1-16 Attaching the color clips to the lead

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Getting Started Patient Interface Module (PIM)

5 Attach the lead to the correct lead connector on the PIM. If any lead connectors on the

PIM are left empty, insert a shorting plug (included in kit).

Figure 1-17 Shorting Plug (included in Lead Kit)

NOTE To configure the 16-lead PIM for standard 12 leads, insert shorting plugs into all of the optional

lead connectors.

Ensure that each lead is firmly connected to the PIM.

Recommended 16-Lead Configurations

Table 1-1 provides some suggested configurations of the 16-lead Patient Interface Module (PIM) for adult and pediatric application.

NOTE The recommended 16-lead configuration options described in Table 1-1 are the only 16-lead options

that are compatible with the TraceMaster ECG Management System.

Table 1-1 15 and 16-Lead PIM Configuration Options

Lead Option Standard 12-leads plus extended

leads (AAMI/IEC)

Pediatric

V3R (C3R), V4R (C4R), V7 (C7)

(15 leads)

Posterior

V7 (C7), V8 (C8), V9 (C9)

(15 leads)

Lead Placement

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Getting Started Installing the Batteries

Table 1-1 15 and 16-Lead PIM Configuration Options (continued)

Lead Option Standard 12-leads plus extended

leads (AAMI/IEC)

Balanced (16 leads)

V3R (C3R), V4R (C4R), V7 (C7), V8 (C8)

Installing the Batteries

The PageWriter TC70 cardiograph is shipped with two batteries, and the PageWriter TC50 cardiograph is shipped with one or an optional two batteries that are used to power the cardiograph when AC power is not available.

Lead Placement

CAUTION Insert the batteries into the cardiograph before plugging the cardiograph into AC power.

Notes about Battery Installation

NOTES  If operating the PageWriter TC50 cardiograph with one battery installed, the battery may be

inserted into either battery compartment.

 When operating the PageWriter TC50 cardiograph with one battery installed, only use the Philips

battery with part number 989803170371. Do not use the battery with Philips part number 989803160981 for one battery operation.

 When operating the PageWriter TC70 or PageWriter TC50 cardiograph with two batteries

installed, ensure that both batteries contain the same Philips part number. The battery part number identification label is found on the bottom of the battery. The cardiograph cannot operate with two batteries that contain different part numbers. If the cardiograph is operated with two batteries with different part numbers, the cardiograph will display an error message and will not operate.

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Getting Started Installing the Batteries

To install the batteries:

Open the battery door.

2 Locate the two gold pull tabs inside of the battery compartment. Pull the tabs straight out

of the battery compartment and lay flat.

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Getting Started Installing the Batteries

3 Insert the battery with the external connector facing the bottom rear of the compartment.

NOTE If operating the PageWriter TC50 cardiograph with one battery installed, the battery may be

inserted into either battery compartment.

Push in the battery and ensure that the battery is fully inserted into the slot. The pull tab will insert along with the battery. Insert the second battery following the same procedure.

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Getting Started Installing the Batteries

5 Reinstall the battery door.

6 Connect the AC power cord to the cardiograph. Charge the batteries for five hours before

operating the cardiograph on battery power only.

Charging the Batteries

Charge the batteries for five hours prior to initial use. Plug the cardiograph into AC power whenever possible, and fully charge the batteries. Proper battery maintenance and care, including frequent and full charging of the batteries, will help to prolong battery life.

There are configurable power saving features available on the cardiograph. These features are used to help prolong overall battery life, and to optimize battery power use between battery charges.

CAUTION When removing the batteries from the cardiograph, the batteries could feel warm to the touch.

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Getting Started Installing the Batteries

Calibrating the Batteries

The batteries may require periodic calibration to ensure the continued accuracy of the battery power and overall battery status information displayed on the cardiograph. When battery calibration is required, a message appears on the Battery Status window. For more information on battery calibration, see “Battery Calibration” on page 5-12.

Battery Power Indicator

The battery power indicator ( ) appears on the Status Bar and is always visible. The indicator displays the current battery power level. The cardiograph can operate on AC power while the batteries are charging, but the batteries will charge at a slower rate.

Figure 1-18 Battery Power Indicator on the Status Bar

A Battery level indicator

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Getting Started Installing the Batteries

To check the battery power level:

From any screen, tap on the battery icon on the Status Bar ( ). The Battery Status window appears. This window provides detailed information on the status of the cardiograph batteries. The battery icon indicates the overall charge status of the battery.

Table 1-2 Battery Icon (on Status Bar or Battery Status window)

Icon on Status Bar Battery Level

Fully Charged Battery

75% power capacity

50% power capacity

Low Battery Power:

 red battery icon appears when power level is below

25%

 cardiograph beeps and an error message appears until

the unit is plugged into AC power (audio feature may be disabled)

 tap the icon to see how many minutes are left of

operating battery power

 If overall battery power is below 15% and the

cardiograph is in Standby, when the On/Standby button is pressed it will flash green five times and the cardiograph will be unable to return to active use. Plug the cardiograph into AC power to recharge the batteries.

No or Dead Battery

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Page 61

Getting Started Using the Wireless LAN Card

NOTE If the Plug in the Cardiograph message appears, the cardiograph needs to be plugged into AC

power immediately.

Figure 1-19 Battery Status Information with Plug in the Cardiograph message

Touch the Close button to close the window.

Using the Wireless LAN Card

The PageWriter TC70 cardiograph and PageWriter TC50 cardiograph both support the Summit Wireless LAN card. The wireless LAN card is used to transfer ECG and order data between the cardiograph and a TraceMaster ECG Management System. The cardiograph can also be configured to transfer ECG data using a wireless connection to a third party ECG management system. For information on configuring cardiograph connectivity with a TraceMaster or other third party ECG management system, see the PageWriter TC70/TC50 Cardiograph Network Configuration Guide available on the User Documentation and Training DVD, or the file can be downloaded from the Philips InCenter site.

CAUTION Only use wireless LAN cards with the PageWriter TC70 or PageWriter TC50 cardiographs that have

been purchased from Philips Medical Systems. The use of non-approved wireless LAN cards with either model cardiograph is not tested or supported, and Philips Medical Systems does not guarantee cardiograph operation or wireless LAN connectivity.

For information on installing the card and configuring the cardiograph for wireless transmission, see the PageWriter TC Cardiograph Wireless LAN Installation Instructions. The file is available for download from the Philips InCenter site (

incenter.medical.philips.com).

For information on ordering the wireless card, see “Supplies and Ordering Information" on page 1-45.

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Getting Started Using the Modem Card

Using the Modem Card

The modem card is an optional accessory that is used to fax ECGs to a configured receiving fax machine, or is used to transfer ECGs or orders by modem between the cardiograph and a TraceMaster ECG Management System. The cardiograph can also be configured to transfer ECG data by modem to a third party ECG management system. For information on configuring cardiograph connectivity with a TraceMaster or other third party ECG management system, see the PageWriter TC70/TC50 Cardiograph Network Configuration Guide available on the User Documentation and Training DVD, or the file can be downloaded from the Philips InCenter site.

For information on ordering the modem card, see “Supplies and Ordering Information” on page 1-45.

WARNING Do not connect the modem card to a phone line when the cardiograph is connected to a

patient.

Using the USB Memory Stick

The USB memory stick is an optional accessory that is used to transfer orders to the cardiograph from a computer that has the WebSelect Utility installed, and can also be used to transfer completed ECGs from the cardiograph to a TraceMaster ECG Management System for reconciliation and processing. The USB memory stick can also be used to save custom settings specified on the Setup screens as a Custom Settings file. This Custom Settings file can then be transferred to additional cardiographs to help speed up the configuration process.

For information on using the WebSelect Utility, see the Using OrderVue with PageWriter Cardiographs guide. This guide is available for download from the Philips InCenter site. For information on the Philips InCenter site, see “Using the Philips InCenter Site" on page 1-5.

CAUTION The PageWriter TC70 and TC50 cardiographs only support the USB memory stick that is available for

purchase as an optional accessory from Philips Medical Systems. Philips does not guarantee that other USB memory sticks are compatible with the PageWriter TC70 or TC50 cardiographs.

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Getting Started Using the Barcode Reader

Figure 1-20 USB memory stick inserted into USB connector

A USB memory stick inserted into USB connector (tip illuminates when properly inserted)

The USB memory stick can store up to 200 ECGs and 200 orders. Ensure that the USB memory stick is firmly inserted into the USB connector located on the front right side of the cardiograph (next to the battery door). The tip of the USB memory stick illuminates when it is properly inserted into the USB connector.

CAUTION Do not insert a USB memory stick into the cardiograph, or remove a USB memory stick from the

cardiograph when the cardiograph is acquiring ECG data from a patient.

CAUTION Only use the USB memory stick to transfer data between a PageWriter TC70 or TC50 cardiograph

and a computer. Do not use the memory stick with other devices.

Using the Barcode Reader

The barcode reader is an optional accessory that is used to quickly enter ID information by scanning a barcode.

The barcode reader attaches to the barcode reader connector ( ) on the rear panel of the cardiograph. Attach the barcode reader to the cardiograph before turning on AC power. For information on ordering the barcode reader, see “Supplies and Ordering Information” on page 1-45.

NOTE The Metrologic Scanner Instructions for Use, which provides complete information on configuring and

using the barcode scanner, is included on the User Documentation and Training DVD.

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Getting Started Using the Cardiograph Touch Screen

Figure 1-21 The Barcode Reader

Using the Cardiograph Touch Screen

The touch screen provides access to all of the c ardiogra ph features. Simply touch the buttons on the screen to open the different screens and to perform different functions.

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Getting Started Using the Cardiograph Touch Screen

A B C

Touch Screen Overview

The touch screen is organized into different areas that are grouped by function. The following sections provide an overview of each area of the touch screen.

Figure 1-22 Touch Screen Overview

Table 1-3 Touch Screen Overview

Touch Screen Item Feature Description

Selected Exam Type

 The Exam Type selected for the current patient

session.

 The available Exam Types are: Resting 12-

Lead ECG.

 Touch the button to change the selected Exam

Type.

, Resting Extended Lead, and Timed

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Getting Started Using the Cardiograph Touch Screen

Table 1-3 Touch Screen Overview (continued)

Touch Screen Item Feature Description

Exam Layout

Current Operating Settings

Status Bar

 The settings underneath this button include the

selected ECG report layout settings, and the level of interpretation generated by the Philips 12 or 16-lead algorithm that are being applied to the selected Exam Type.

 Any of the settings on this screen may be

edited, and the new settings are applied to the current patient session.

 The settings underneath this button include the

selected filters (Artifact, Baseline Wander), pacing detection setting, and report scaling settings being applied to the current patient session.

 The Unknown pacing setting is recommended

for most ECGs.

Displays information about the current cardiograph settings, including selected Exam Type, current patient name, network connectivity status, PIM status, and the current date and time.

Waveform Display

Toolbar

Help

Setup

Display area for ECG waveforms. Lead connection quality is indicated by the color of the waveform.

Press the up arrow ( ) or the down arrow ( ) key (on keyboard) to change the displayed lead format.

All cardiograph ECG acquisition modes and ECG management features.

Provides information on how to use the cardiograph.

The settings underneath this button are used to configure or change cardiograph settings, or to access the service utilities. Access to these screens may require entering a password.

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Getting Started Using the Cardiograph Touch Screen

Table 1-3 Touch Screen Overview (continued)

Touch Screen Item Feature Description

ECG Storage and Management Features

 Provides access to the ECG Archive, which is

used as temporary storage for all ECGs acquired on the cardiograph.

 From the Archive, ECGs may be transferred to

a TraceMaster ECG Management System, or a third party ECG management system.

 From the Archive, a TraceMaster server may

be searched for previous ECGs to view and print on the cardiograph.

 The number on the button (9) displays the

number of ECGs currently stored in the Archive.

Rhythm and Disclose Features

 The Rhythm feature is used to print continuous

rhythm strips of up to 12 or 16 selected leads until the

 The Disclose feature is used to review captured

Stop button is touched.

Events, to view continuous data from one selected lead, or to print ECG reports in a variety of formats.

 The number on the Disclose button (0) displays

the number of Events currently stored in Disclose.

1-2-3 Operation Features

The Map, ID, and ECG buttons are used in sequence to acquire and print a standard 12-lead or 16-lead ECG.

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Getting Started Using the Cardiograph Touch Screen

Using the Main ECG Screen

The main screen displays 10 seconds of continuous ECG waveform data for each lead on one single screen, or can display a split screen view with various views of continuous ECG waveform data for each lead.

Figure 1-23 Main Screen with Split Screen View (12 Leads Displayed)

A Limb Leads B Precordial Leads

To change the lead display on the main screen:

Press the down arrow key (on keyboard) to display all leads on a split screen view. The split screen view provides five seconds of continuous ECG waveform data for each lead. The left side of the split screen displays the limb leads, and the right side displays all precordial leads. Press the down arrow key (on keyboard) again to view additional lead configurations.

2 Press the up arrow key (on keyboard) to change the display back to a standard 12, 15,

or 16-lead view with no split screen. The standard view provides ten seconds of continuous ECG waveform data for each lead.

1-42 PageWriter TC70/TC50 Cardiograph Instructions for Use

Page 69

Getting Started Using the Cardiograph Touch Screen

ABC DEFGH

The Status Bar

The Status Bar (top of the screen) provides information about the current cardiograph settings. The Status Bar is always visible.

Figure 1-24 The Status Bar

Table 1-4 The Status Bar

Status Bar Item Feature Description

Selected Exam Type

ECG Layout

Operating Settings

Event Marker Alert

 The Exam T ype selected for the current patient

session.

 The available Exam Types are: Resting 12-

Lead

, Resting Extended Lead, and Timed

ECG

 The current ECG report layout settings,

including the level of interpretation generated by the Philips 12 or 16-lead algorithm.

 Any of the settings on this screen may be

edited for the current patient session.

 The current selected filters (Artifact, Baseline

Wander), pacing detection setting, and report scaling settings.

 The Unknown pacing setting is recommended

for most ECGs.

 If this flashing icon appears, saved Event

markers ( ) have not yet been reviewed on the Disclose screen, and will be deleted within the next 5 minutes (TC70 cardiograph), or the next 2 minutes (TC50 cardiograph).

 Touch the Disclose button on the toolbar to

review saved Events.

PageWriter TC70/TC50 Cardiograph Instructions for Use 1-43

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Getting Started Using the Cardiograph Touch Screen

Table 1-4 The Status Bar (continued)

Status Bar Item Feature Description

PIM Disconnected

Caps Lock

LAN and Wireless LAN Connectivity

 If this icon appears, the Patient Interface

Module (PIM) is not connected to the cardiograph, or that a Class A PIM is connected to a PageWriter TC50 cardiograph.

 Check that the PIM cable is firmly attached to

the connector on the cardiograph, and that there are no breaks or cracks in the cable. Ensure that a Class B PIM is only used with a PageWriter TC50 cardiograph, see “About Class A and Class B Patient Data Cables and PIMs" on page 1-21.

 Indicates that the Caps Lock setting is enabled

(keyboard types in all capital letters).

 Touch the Caps Lock key (on keyboard) to

disable the setting.

LAN connectivity:

 Indicates if the cardiograph is connected to a

live Ethernet connection through the LAN connector ( ) on the rear of the cardiograph.

 If no LAN connection is detected, a red “x”

mark appears on the icon ( ).

Wireless LAN connectivity:

 Indicates the signal strength of a the wireless

LAN connection.

 Green bars indicate that the wireless adapter is

associated to an access point. The higher the number of green bars, the better the connection.

 No bars indicates that the cardiograph is losing

the wireless LAN signal and that the cardiograph should be moved to an area with a stronger signal.

 Gray solid bars ( ) indicate that the wireless

adapter is unable to associate to an access point.

1-44 PageWriter TC70/TC50 Cardiograph Instructions for Use

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Getting Started Supplies and Ordering Information

Table 1-4 The Status Bar (continued)

Status Bar Item Feature Description

Battery Power Indicator

Date and Time

Heart Rate Indicator

 Displays the available battery power. For more

information, see “Battery Power Indicator" on page 1-33.

 Displays the current date and time.  The date and time can be set manually, or the

cardiograph can be configured to automatically synchronize the date and time with a TraceMaster ECG Management server.

 Go to the Archive or Setup screens to

manually change the date and time (accessing these screens may require entering a password.) Tap the displayed date and time to edit the settings.

 Displays the patient heart rate in beats per

minute.

 The icon appears in white when no patient is

attached to the cardiograph

Note: The heart rate indicator measurement has been verified with a simulator that can generate ECG waveforms up to 240 bpm (beats per minute). Accuracy of this measurement beyond 240 bpm has not been verified.

Patient Date of Birth, Name, and ID Number

Displays the date of birth, patient name, and patient ID number for the current patient session.

Supplies and Ordering Information

The part numbers for all supplies for the PageWriter TC70 and PageWriter TC50 cardiographs are listed in this section.

Ordering Supplies

All supplies may be ordered on the web at:

http://shop.medical.philips.com

PageWriter TC70/TC50 Cardiograph Instructions for Use 1-45

Page 72

Getting Started Supplies and Ordering Information

Use the part numbers listed in this section to ensure that the correct supplies are ordered.

Special Note about Welsh Bulb Electrodes

Figure 1-25 Welsh Bulb Electrode

Welsh Bulb electrodes are offered as an optional supply part with the PageWriter TC70 and PageWriter TC50 cardiographs. Special care is necessary when using these electrodes. Pay special attention to all warnings associated with these electrodes. For information on cleaning the reusable Welsh Bulb electrodes, see “Reusable Electrode Cleaning" on page 5-4. Philips Medical Systems recommends the use of disposable electrodes with the PageWriter TC70 or PageWriter TC50 cardiograph.

WARNING The Welsh bulb electrodes (available as an accessory for the cardiograph) do not meet

the requirements of IEC 60601-2-25 for defibrillation recovery time, and cannot be reliably used for patient diagnosis immediately following defibrillation.

WARNING Always clean and disinfect reusable electrodes before patient use. See “Reusable

Electrode Cleaning” on page 5-4 for information on cleaning and disinfecting reusable electrodes. Failure to properly clean and disinfect reusable electrodes before patient use may cause infectious materials to be transferred between patients.

CAUTION The Welsh bulb electrodes contain natural rubber latex which may cause allergic reactions.

PageWriter TC70 and PageWriter TC50 Cardiograph Supply Part Numbers

PIM Patient Data Cable

Part Number Description

989803158481 Class A Patient Data Cable, 5-pin (2.0 meters/6.56 feet length)

Note: this patient data cable is only compatible with a Class A PIM for the PageWriter TC70 cardiograph, see page 1-21.

989803164281 Class B Patient Data Cable, 8-pin (2.0 meters/6.56 feet length)

Note: this patient data cable is only compatible with a Class B PIM, see page 1-21.

1-46 PageWriter TC70/TC50 Cardiograph Instructions for Use

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Getting Started Supplies and Ordering Information

Complete Lead Sets

Part Number Description

989803151631 Complete AAMI Lead Set for Standard 12 Leads (arm lead 99

cm/39 in, leg lead 104.1 cm/41 in, chest leads 69.8 cm/27.5 in)

989803151641 Complete IEC Lead Set for Standard 12 Leads (arm lead 99 cm/

39 in, leg lead 104.1 cm/41 in, chest leads 69.8 cm/27.5 in)

989803151711 Limb Lead Set (AAMI/IEC) (arm lead 99 cm/39 in, leg lead 104.1

cm/41 in)

989803151671 Complete Chest Lead Set (AAMI/IEC) (chest leads 69.8 cm/27.5

in)

989803151651 Long Complete AAMI Lead Set for Standard 12 Leads (arm lead

137.1cm/54 in, leg lead 142.2 cm/56 in, chest leads 69.8 cm/27.5 in)

989803151661 Long Complete IEC Lead Set for Standard 12 Leads (arm lead

137.1cm/54 in, leg lead 142.2 cm/56 in, chest leads 106.6 cm/42 in)

989803151731 Long Limb Lead Set (AAMI and IEC) (arm lead 137.1cm/54 in,

leg lead 142.2 cm/56 in) 989803151691 Long Chest Lead Set (AAMI/IEC) (chest leads 106.6 cm/42 in) 989803151751 16-Lead Kit for AAMI Leads (arm lead 99 cm/39 in, leg lead

104.1 cm/41 in, chest leads 69.8 cm/27.5 in, extended leads 83.8

cm/33 in) 989803151761 16-Lead Kit for IEC Leads (arm lead 99 cm/39 in, leg lead 104.1

cm/41 in, chest leads 69.8 cm/27.5 in, extended leads 83.8 cm/33

in) 989803151771 Long 16-Lead Kit for AAMI Leads (arm lead 137.1cm/54 in, leg

lead 142.21 cm/56 in, chest leads 106.6cm/42 in, extended leads

121.9cm/48 in)

989803151781 Long 16-Lead Kit for IEC Leads (arm lead 137.1cm/54 in, leg

lead 142.21 cm/56 in, chest leads 106.6cm/42 in, extended leads

121.9cm/48 in)

Lead Accessories

Part Number Description

989803129231 Alligator Clips for Disposable Tab Electrodes (AAMI)

(10 total per pack)

989803129241 Alligator Clips for Disposable Tab Electrodes (IEC)

(10 total per pack)

PageWriter TC70/TC50 Cardiograph Instructions for Use 1-47

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Getting Started Supplies and Ordering Information

Lead Accessories

Part Number Description

989803101361 Alligator Clip Extender (Pediatric) for Disposable Tab

Electrodes (10 total per pack) (AAMI)

989803101371 Alligator Clip Extender (Pediatric) for Disposable Tab

Electrodes (10 total in pack) (IEC)

989803106061 Wide Disposable Tab Electrode Connector

(10 total per pack) (AAMI/IEC)

989803166031 Clear Tab with Snap Adapter (AAMI) (10 total

electrodes)

989803101701 IEC Snap Lead Adapter (converts IEC connector to

grabber connector for use with snap dispos able electrode s and 4mm banana plug termination cables)

989803151701 16-Lead Spare Parts Kit (includes color rings, shorting

plugs, lead separators and banana post adapters)

Disposable and Reusable Electrodes

Part Number Description

989803100441 Solid gel tab disposable cardiography electrode, resting diagnostic

ECG (35 mm x 22 mm, 1.37 x .86 in) (1000 total electrodes)

989803106051 Solid gel tab disposable cardiography electrode, resting diagnostic

ECG (33 mm x 20 mm, 1.29 x .78 in) (1000 total electrodes)

989803149901 Pediatric disposable tab electrode (14 mm x 34 mm, .55 x 1.33 in)

(1000 total electrodes)

989803101311 Reusable Welsh Bulb Electrode 15 mm diameter (AAMI) (6 total

electrodes)

989803101651 Reusable Welsh Bulb Electrode 15 mm diameter (IEC) with banana

plug adapter (1 total electrode)

989803101281 Reusable Welsh Bulb Electrode (IEC) with side screw connection

(6 total electrodes) 989803101661 Reusable Adult Limb Plate Electrode (IEC) (4 total electrodes) 989803101691 Reusable Adult Limb Clamp Electrode (4 total electrodes)

(AAMI/IEC) 989803101341 Reusable Adult Limb Plate Electrode for push-in type connection,

nickel-silver (4 total electrodes) (AAMI/IEC) 989803100601 Rubber Strap for Reusable Limb Plate Electrodes (38 cm/15 in)

(4 total straps) (AAMI/IEC)

1-48 PageWriter TC70/TC50 Cardiograph Instructions for Use

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Getting Started Supplies and Ordering Information

Printer Paper

Part Number Description

989803106261 Z-fold, with header, A size (21.6 x 28 cm/8.5 x 11 in) 989803106271 Z-fold, with header, A4 size (21 x 29.69 cm/8.27 x 11.69 in) 989803106281 Anti-fade, A size (21.6 x 28 cm/8.5 x 11 in) 989803106291 Anti-fade, A4 size (21 x 29.69 cm/8.27 x 11.69 in)

Batteries

Part Number Description

989803160981 Lithium-ion replacement battery (2 battery operation only for

PageWriter TC70 and TC50 cardiographs)

989803170371 Lithium-ion replacement battery (1 battery operation for

PageWriter TC50 only, or for 2 battery operation for both PageWriter TC70 and TC50 cardiographs)

Keyboard Covers

Part Number Description

989803166511 PageWriter TC70 Cardiograph Keyboard Cover (5 per pack) 989803166501 PageWriter TC50 Cardiograph Keyboard Cover (5 per pack)

Replacement Fuse

Part Number Description

453564131221 PageWriter TC50 Cardiograph 1.6 amp (250 V) Replacement

Fuse

USB Memory Stick

Part Number Description

989803145331 USB Memory Stick

PageWriter TC70/TC50 Cardiograph Instructions for Use 1-49

Page 76

Getting Started Ordering Options and Upgrades

Ordering Options and Upgrades

For more information on ordering any of the following cardiograph upgrades or options, please contact your Philips Sales Representative or your local distributor.

Table 1-5 Data Input Options

Option Number Description

H12 Barcode Reader H13 Magnetic Card Reader H14 Smart Card Reader

Table 1-6 Patient Interface Module (PIM) Options

Option Number Description

H21 12-Lead Patient Interface Module (PIM) (AAMI or IEC) H22 16-Lead Patient Interface Module (PIM) (AAMI or IEC)

Table 1-7 Software Upgrades

Option Number Description

D01 Orders support (order system connectivity) D07 Manual order entry support (user entered orders) D12 Last ECG and Interactive Query support (requires

TraceMaster ECG Management System) D21 Wireless LAN support (802.11b/g) D22 Wireless LAN support (802.11a, 802.11b/g) H11 Global Modem support

Table 1-8 Cardiograph Cart and Accessories

Option Number Description

B01 Partially Assembled Cardiograph Cart B02 Fully Assembled Cardiograph Cart (only available in USA) C01 TC70 Cardiograph Cart Drawer C02 TC50 Cardiograph Additional Cart Storage Bin/TC70

Cardiograph Additional Wire Storage Bin C03 Patient Cable Arm

1-50 PageWriter TC70/TC50 Cardiograph Instructions for Use

Page 77

Getting Started Product Troubleshooting

Table 1-9 Keyboard Cover

Option Number Description

H16 Keyboard Cover

Product Troubleshooting

For information on product troubleshooting, see the PageWriter TC Cardiograph Service Manual included on the User Documentation and Training DVD, or the file may be

downloaded from the Philips InCenter site. For information on using the InCenter site, see page 1-5. This document provides comprehensive information on product troubleshooting, performance verification and safety tests, using the Service Utilities accessed from the Setup menu, and installing software upgrades. The Service Manual is only available in English. For more comprehensive information on product troubleshooting, contact the nearest Philips Response Center for further assistance.

Contacting a Philips Response Center

The Philips Response Center can assist with product troubleshooting and provide technical expertise to help with any issue with the PageWriter TC cardiographs or any of its accessories.

For more information on the Philips Response Center go to:

www.medical.philips.com/main/services/response_center

North America Response Centers

Country Telephone Number

Canada (800) 323 2280 Mexico 01 800 710 8128 Puerto Rico 1 787 754 6811 United States (800) 722 9377

South America Response Centers

Country Telephone Number

Argentina 54 11 4546 7698 Brazil 0800 701 7789 Chile 0800 22 3003 Columbia 01 8000 11 10 10 Peru 51 1 620 6440

PageWriter TC70/TC50 Cardiograph Instructions for Use 1-51

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Getting Started Contacting a Philips Response Center

Europe Response Centers

Country Telephone Number

United Kingdom 44 0870 532 9741

Fax: 44 01737 23 0550 Austria 43 1 60101 820 Belgium 32 2 525 7102 (French)

32 2 525 7103 (Flemish) Czech Republic

31 40 2781619 MCR Response Center

(located in The Netherlands)

Denmark 45 80 30 30 35 Finland 358 615 80 400 France 0 810 835 624 Germany 0180 5 47 5000 Greece

31 40 2781619 MCR Response Center

(located in The Netherlands)

Hungary

31 40 2781619 MCR Response Center

(located in The Netherlands)

Italy 0800 232100 Netherlands 31 40 27 211 27 Norway 47 800 84 080 Poland

31 40 2781619 MCR Response Center

(located in The Netherlands)

Rumania

31 40 2781619 MCR Response Center

(located in The Netherlands)

1-52 PageWriter TC70/TC50 Cardiograph Instructions for Use

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Getting Started Contacting a Philips Response Center

Europe Response Centers

Country Telephone Number

Russia

31 40 2781619 MCR Response Center

(located in The Netherlands)

Slovak Republic

31 40 2781619 MCR Response Center

(located in The Netherlands)

Spain 34 90 230 4050 Sweden 46 200 81 00 10 Switzerland 0800 80 3000 (German)

0800 80 3001 (French)

Asia Response Centers

Country Telephone Number

Australia 1800 251 400 China 800 810 0038 Hong Kong 852 2876 7578 India 1600 112 444 Indonesia 62 21 7910040, ext 8610 Japan 81 (0)120 095 205 Korea 82 (0)2 3445 9010 Malaysia 1800 886 188 New Zealand 0800 251 400 Philippines 63 2 8162617 ext. 875 Singapore 1800 Philips Taiwan 0800 005 616 Thailand 66 (0)2 614 3569

PageWriter TC70/TC50 Cardiograph Instructions for Use 1-53

Page 80

Getting Started Contacting a Philips Response Center

Africa and Middle East

Country Telephone Number

All countries MCR Response Center

(located in The Netherlands)

31 40 2781619

1-54 PageWriter TC70/TC50 Cardiograph Instructions for Use

Page 81

1Configuring Default Clinical Settings

All of the settings on the PageWriter TC70 cardiograph or PageWriter TC50 cardiograph may be customized to meet the needs of a specific clinical environment. The cardiograph is shipped with factory default settings, and any of these settings may be changed. All configuration of the cardiograph is completed on the

Configuring the Wireless LAN Card

For information on configuring the wireless LAN option, see the PageWriter TC Cardiograph Wireless LAN Installation Instructions provided with the wireless adapter, or download the

file from the Philips InCenter web site ( the Philips InCenter web site, see page 1-5.

incenter.medical.philips.com). For information on using

Password Access

Setup screens.

Access to all functions that are used to configure the cardiograph may be set to be password access controlled.

Tips for Creating Secure Passwords

Use the following guidelines when creating passwords used on the cardiograph:

 Include at least one upper case character  Include at least one number  Create passwords at least eight characters in length  Do not use common words, names, or other easily identified terms

Configuration with a Philips TraceMaster ECG Management System

For information on configuring networking and other setti ngs on the cardio graph that are used with a TraceMaster ECG Management System (including the OrderVue order handling option), see the PageWriter TC Cardiograph Network Configuration Guide (only available in English) included on the User Documentation and Training DVD, or download the file from the Philips InCenter web site ( InCenter site, see "Using the Philips InCenter Site" on page 1-5.

incenter.medical.philips.com). For information on the Philips

2-1

Page 82

Configuring Default Clinical Settings Configuration with a Third Party ECG Management System

For more comprehensive information on configuring the PageWriter TC cardiograph, or other Philips PageWriter cardiographs with a TraceMaster ECG Management System, see the Installing TraceMaster and Configuring Communication Guide (only available in English) available for download from the Philips InCenter web site ( information on using the Philips InCenter web site, see page 1-5.

incenter.medical.philips.com). For

Configuration with a Third Party ECG Management System

For information on configuring networking and other settings on the cardiograph that are used with a third party ECG management system, see the PageWriter TC Cardiograph Network Configuration Guide (only available in English) included on the User Documentation and Training DVD, or download the file from the Philips InCenter web site (

incenter.medical.philips.com). For information on the Philips InCenter site, see "Using the

Philips InCenter Site" on page 1-5.

Restoring Custom Configuration Settings

After configuring the cardiograph, save the settings to a USB memory stick in case of system failure. If the cardiograph loses custom settings, the settings may be quickly and easily restored by loading them onto the cardiograph from a USB memory stick.

Configuring Multiple Cardiographs

When configuring multiple cardiographs with the same TraceMaster and OrderVue settings, you can save all settings to a USB memory stick, and then upload them to additional PageWriter TC70 or PageWriter TC50 cardiographs.

NOTE You cannot transfer custom settings between different models of cardiographs. For example, you can

only transfer custom settings from a PageWriter TC70 cardiograph to another PageWriter TC70 cardiograph, and not to a PageWriter TC50 cardiograph.

NOTE Wireless LAN card settings specified in the Summit WLAN Adapter are saved with the custom

settings file.

2-2 PageWriter TC70/TC50 Cardiograph Instructions for Use

Page 83

Configuring Default Clinical Settings Opening the Setup Screens

Opening the Setup Screens

To open the setup screens:

 Touch the Setup button on the Toolbar. The Setup menu appears.

Figure 2-1 The Setup and Service Utilities Menu

Table 2-1 Setup and Service Utilities Menu

Menu Item Feature Description

Configure Cardiograph Default Settings

 T ouch to configure all clinical settings used

on the cardiograph

 Touch to configure password and power

save features

 Includes Maintenance Tests that can be

used to troubleshoot or to optimize cardiograph performance. For more information, see "Cardiograph Care and Maintenance" on page 5-1.

PageWriter TC70/TC50 Cardiograph Instructions for Use 2-3

Page 84

Configuring Default Clinical Settings Using Online Help

Table 2-1 Setup and Service Utilities Menu (continued)

Menu Item Feature Description

Configure ECG Network Settings

Service Utilities

Using Online Help

Each configuration screen within the cardiograph software application provides Help that describes the currently selected option or field. Use the Help when configuring cardiograph settings, or to learn more about a specific feature or item.

 Touch to configure TraceMaster and

OrderVue settings, or to configure the PDF Export option for a remote PC or server, or to configure settings for a third party (nonPhilips) ECG Management System

 For more information, see the PageWriter

TC Cardiograph Network Configuration Guide (only available in English)

 Touch to access the Service Utilities,

including all maintenance and performance tests, and software upgrades

 For more information on using the Service

Utilities, see the PageWriter TC Cardiograph Service Manual (only

available in English)

When a configuration screen is opened, Help displays in the blue Information box located at the bottom of the screen. Touch a tab, or touch the name of any field or option displayed on the screen to change the Help for that specific item. A highlighted field or option appears in blue type.

To view help for a tab or field:

 Touch a tab or touch the name of the field or option so that it is highlighted in blue. Help

for the selected item displays in the blue Information box at the bottom of the screen (see Figure 2-2 on page 2-5).

2-4 PageWriter TC70/TC50 Cardiograph Instructions for Use

Page 85

Configuring Default Clinical Settings Configuring 12-Lead and 16-Lead Exam Settings

Information

Box

Figure 2-2 The Information Box on a Setup screen

Configuring 12-Lead and 16-Lead Exam Settings

The Exam setup wizard is used to specify ECG operating settings for 12 and for 16-lead ECGs. Each set of defined settings is saved as an individual Exam Profile that can be selected during a patient session.

NOTES The 16-lead Exams settings will only appear if a 16-lead Patient Interface Module (PIM) is connected to

the cardiograph.

For information on configuring the 16-lead PIM for use with the PageWriter TC70 cardiograph, see "Configuring the 16-Lead PIM" on page 1-26.

To configure 12 or 16-lead Exams settings:

Touch the Exams button (top left of screen) on the Default Cardiograph Settings screen.

2 The Exams setup screens appear. The Manage Exams tab is selected (in blue).

PageWriter TC70/TC50 Cardiograph Instructions for Use 2-5

Page 86

Configuring Default Clinical Settings Configuring 12-Lead and 16-Lead Exam Settings

Figure 2-3 The Exams Setup screens

A Exams button selected

Manage Exams tab selected

Touch a button under Create a New Exam to begin creating a new Exam for Resting 12lead, Resting Extended (16-lead), or Timed ECG.

4 On the following screen select a lead sequence (Standard or Cabrera) and a lead standard

(

AAMI or IEC). Touch the Next button (bottom right of screen) to continue.

5 On the following screen, select a report format to specify for this Exam. Select the Rhythm

leads for the selected report format (if necessary). Touch the

6 Select the settings for the selected report format, these settings include the waveform scale

Next button to continue.

and size settings, and if the ECG data shown on the report is captured simultaneously, or time sequentially. On the right side of the screen, select an interpretation level for the Philips 12-lead or 16-lead algorithm. Touch the

NOTES The Print Severity setting enables the printing of the ECG severity on the ECG report. For

more information on the Severity setting, see "Interpretive, Reason, and Severity Statements" on page 4-3.

The Extended Measurements setting enables the printing of the full Extended Measurements Report with each ECG. For information on the Extended Measurements Report, see "Extended Measurements Report" on page 4-43.

Next button to continue.

The following screen specifies the Rhythm leads and the waveform speed and scale settings for all Rhythm reports printed using the specified Exams setting.

8 Touch the Back button to return to any previous screen and make edits. Touch the Save

button when complete.

2-6 PageWriter TC70/TC50 Cardiograph Instructions for Use

Page 87

Configuring Default Clinical Settings Configuring 12-Lead and 16-Lead Exam Settings

9 The Create New Exam profile window appears. Enter a name for the Exam. Touch OK.

PageWriter TC70/TC50 Cardiograph Instructions for Use 2-7

Page 88

Configuring Default Clinical Settings Configuring 12-Lead and 16-Lead Exam Settings

2-8 PageWriter TC70/TC50 Cardiograph Instructions for Use

Page 89

1The Patient Session

Introduction

A patient session is the period of time when waveform data is acquired and processed from a single patient. A patient session begins by entering accurate patient information. Patient information is then linked with all waveform data acquired during the patient session.

CAUTION Entering accurate patient information (age, gender) is highly recommended if using the Philips 12-Lead

Algorithm, version PH090A, or the Philips DXL ECG Algorithm, version PH100B, for ECG interpretation. For more information see the applicable Physician’s Guide on the PageWriter TC Cardiograph User Documentation and Training DVD, or download the file from the Philips InCenter site (incenter.medical.philips.com).

The steps in a typical patient session are described below.

Table 3-1 The Patient Session

The Patient Session

Prepare the Patient

Step Description More Information See...

1 Prepare the patient for the procedure. “Patient Preparation” on page 3-4. 2 Prepare the electrode sites and attach the

electrodes.

3 Attach the lead wires. “Attaching the Lead Wires” on page 3-14.

 “Preparing the Skin” on page 3-4.  “Electrode Placement” on page 3-5.  “Attaching Disposable Electrodes” on

page 3-12.

 “Attaching Welsh Bulb and Limb Clamp

Electrodes” on page 3-13.

3-1

Page 90

The Patient Session Introduction

Table 3-1 The Patient Session (continued)

The Patient Session

Enter Patient Information or Take a STAT ECG

Step Description More Information See...

1 Return the cardiograph to active use.  “Using the On/Standby Button” on

page 3-15.

2  Take an urgent/STAT ECG

 Enter patient information or select an order

from the Worklist

 “Urgent (STAT) ECGs” on page 3-24.  “Entering Patient Information” on

page 3-16.

Check the Signal Quality

Step Description More Information See...

1 When the patient is connected to the

cardiograph, color-coded ECG waveforms appear on the Main screen. Check the signal quality.

2 Touch the Map button on the cardiograph to

check electrode connection.

“Checking Signal Quality” on page 3-19.

“Leads Map” on page 3-20.

Select an ECG Acquisition Mode

Step Description More Information See...

1 Do any of the following:

 Capture Events for review on the Disclose

screen

“Capturing Events from the Main or Rhythm Screens” on page 3-33.

 Print an Auto ECG “Main ECG Screen” on page 3-24.  Print a Rhythm report “Rhythm ECG Acquisition” on page 3-30.  Use the Disclose feature to:

– review Events captured on the Main or

Rhythm screens

– print a 12 or 16-lead ECG of captured

Event data

– view continuous waveform data for a

selected Disclose lead

– print a 1-minute report of a selected

Disclose lead

– view live waveform data for a selected

Disclose lead

3-2 PageWriter TC70/TC50 Cardiograph Instructions for Use

“Disclose ECG Acquisition” on page 3-33.

Page 91

The Patient Session Introduction

Table 3-1 The Patient Session (continued)

The Patient Session

Step Description More Information See...

 Use the Timed ECG feature to:

“Using Timed ECG” on page 3-37.

– Take ECGs at preset intervals

View, Print, Save, and Transfer ECG(s) from the Preview Screen

Step Description More Information See...

1 Compare the most recent ECG from the same

patient using the

Last ECG feature (requires an

active TraceMaster connection)

 “Using the Last ECG Feature on the

Preview Screen” on page 3-28.

 “Critical Values on Preview Screen” on

page 3-29.

End the Patient Session

Step Description More Information See...

1 Disconnect the patient.

Transfer ECGs from the Archive

Step Description More Information See...

1 Transfer completed ECGs from the Archive as a

PDF file or as an XML file using a USB memory stick, or a network or modem connection.

 “Transferring ECGs from the Archive” on

page 3-38.

2 Download ECGs from TraceMaster to the

cardiograph using a network or modem

 “Downloading ECGs from TraceMaster”

on page 3-39.

connection.

The patient session ends when:

 New patient information is entered or a pending order is selected  The cardiograph enters Standby or is shut down  Archive or Setup are selected

PageWriter TC70/TC50 Cardiograph Instructions for Use 3-3

Page 92

The Patient Session Patient Preparation

Patient Preparation

Thorough patient preparation techniques are essential for a good quality ECG. Follow the procedures listed in this section to ensure a quality ECG for each patient.

TIP Good ECG technique is very important to achieve the best quality results.

Instructing the Patient

Before attaching the electrodes, greet the patient and explain the procedure. Explaining the procedure decreases anxiety and informs the patient about what to expect.

 Privacy is important to relaxation. When possible, take the ECG in a quiet room or area

where others can’t see the patient. Draw the curtains around the bed when taking the ECG in a room with other people.

 Reassure the patient that the procedure is painless.  Make sure the patient is lying down and is comfortable. The patient’s arms and hands must

be relaxed. If the table is too narrow, place the patient’s hands under the buttocks to prevent muscle tension in the arms.

Once the electrodes and lead wires are attached, instruct the patient to:

 Remain still and do not talk  Breathe normally  Try not to shiver  Do not chew or clench teeth

The more relaxed the patient, the less the ECG will be affected by noise.

Preparing the Skin

Thorough skin preparation is very important. The skin is a poor conductor of electricity and frequently creates artifact that distorts the ECG signal. There is a natural resistance on the skin surface due to dry, dead epidermal cells, oils, and dirt.

TIP The area of the skin where the electrodes are applied must be clean and free of skin oil.

To prepare the skin:

Clip hair from electrode sites if necessary (excessive hair prevents a good connection).

2 Wash thoroughly with soap and water. 3 Dry the skin vigorously to increase capillary blood flow to the tissues and to remove the

dead, dry skin cells and oil.

TIP Do not use alcohol to clean the skin because it dries the skin. If there is no time to follow the

procedure above, rub the site with gauze to remove dead, dry skin and to increase capillary flow.

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Electrode Placement

Review the following lead wire labeling and electrode placement information to ensure a quality ECG.

Table 3-2 AAMI and IEC Lead Labeling and Electrode Placement

AAMI Lead IEC Lead Electrode Position

On the right leg (inside calf, midway between knee and ankle)

On the left leg (inside calf, midway between knee and ankle)

On the right arm (on the inside)

On the left arm (on the inside)

Right side of the sternum in the 4th intercostal space

Left side of the sternum in the 4th intercostal space

Midway between V2 and V4

Left midclavicular line in the 5th intercostal space

Anterior axillary line at the same level as V4

Left midaxillary line at the same level as V4

Midway between V1 and V4R, right side of chest

Midclavicular line in the fifth intercostal space, right side of chest

Left posterior axillary line at the same level as V6

Under the left mid-scapular line at the same level as V6

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V3/C3

V4/C4

V5/C5

V6/C6

LA/L

LL/FRL/N

RA/R

V1/C1

V2/C2

Table 3-2 AAMI and IEC Lead Labeling and Electrode Placement (continued)

AAMI Lead IEC Lead Electrode Position

Left paraspinal border at the same level as V6

Figure 3-1 Male Standard 12-Lead Electrode Placement (AAMI/IEC)

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V3/C3

V4/C4

V5/C5

V6/C6

LA/L

LL/F

RL/N

RA/R

V1/C1

V2/C2

Figure 3-2 Female Standard 12-Lead Electrode Placement (AAMI/IEC)

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V1/C1

V2/C2

V3/C3

V3R/C3R

V4R/C4R

V4/C4

V5/C5

V6/C6

RA/R

LA/L

LL/FRL/N

V7/C7

Figure 3-3 Pediatric 15-Lead Electrode Placement (AAMI/IEC)

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V1/C1 V2/C2

V3/C3

V4/C4

V5/C5

V6/C6

V3R/C3R

V4R/C4R

RA/R LA/L

LL/FRL/N

V7/C7

V8/C8

Figure 3-4 Male Balanced 16-Lead Electrode Placement (AAMI/IEC)

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V1/C1 V2/C2

V3/C3

V4/C4

V5/C5

V6/C6

V3R/C3R

V4R/C4R

RA/R LA/L

LL/FRL/N

V7/C7

V8/C8

Figure 3-5 Female Balanced 16-Lead Electrode Placement (AAMI/IEC)

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V1/C1

V2/C2

V3/C3

V4/C4

V5/C5

V6/C6

V7/C7

RA/R

LA/L

LL/F

RL/N

V9/C9

V8/C8

Figure 3-6 Male Posterior 15-Lead Electrode Placement (AAMI/IEC)

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V1/C1 V2/C2

V3/C3

V4/C4

V5/C5

V6/C6

V7/C7

RA/R LA/L

LL/FRL/N

V8/C8

V9/C9

Figure 3-7 Female Posterior 15-Lead Electrode Placement (AAMI/IEC)

Attaching Disposable Electrodes

For the best quality ECG, ensure that all skin preparation procedures described in “Preparing the Skin” on page 3-4 have been followed.

To attach disposable electrodes:

Expose the arms and legs of the patient (to place the limb electrodes).

2 Place the electrodes on flat, fleshy parts of the arms and legs. 3 Place the electrodes on the inside of each arm (between the wrists and elbows). 4 Place the electrodes on the inside of each calf (between the knee and the ankle). 5 Place the limb electrodes equal distance from the heart. Position the electrodes at the same

place on each limb.

6 If a limb site is not available (amputation, injury) place the electrodes closer to the torso. 7 Attach the electrodes to the skin. A good test for firm electrode contact is to try to move it.

If it moves easily, the electrode connection is too loose. Do not allow the electrodes to move in any way.

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