Philips PageWriter TC70, PageWriter TC50 User manual

PageWriter TC70/TC50 Cardiograph

INSTRUCTIONS FOR USE

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

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

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

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

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

Contents-4 PageWriter TC70/TC50 Cardiograph Instructions for Use

Table of Contents

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

PageWriter TC70/TC50 Cardiograph Instructions for Use Contents-5

Table of Contents

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

Contents-6 PageWriter TC70/TC50 Cardiograph Instructions for Use

Table of Contents

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

PageWriter TC70/TC50 Cardiograph Instructions for Use Contents-7

Table of Contents

Contents-8 PageWriter TC70/TC50 Cardiograph Instructions for Use

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

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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