Philips PageWriter TC20 Instructions For Use Manual

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PageWriter TC20 Cardiograph

INSTRUCTIONS FOR USE

PageWriter TC20 Cardiographs

INSTRUCTIONS FOR USE

Edition 1

July 2011

Notice

About This Edition

Published by Philips Healthcare Printed in USA Publication number 453564267371

Edition History

Edition 1, July 2011 Software revision A.05 and higher

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

Proprietary Notice

This document and the information contained in it is proprietary and confidential information of Philips Medical Systems (“Philips”) and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to others, or disseminated without the prior written permission of the Philips Legal Department. Use of this document and the information contained in it is strictly reserved for current Philips personnel and Philips customers who have a current and valid license from Philips for use by the customer’s designated in-house service employee on equipment located at the customer’s designated site. Use of this document by unauthorized persons is strictly prohibited. Report violation of these requirements to the Philips Legal Department. This document must be returned to Philips when the user is no longer licensed and in any event upon Philips’ first written request.

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

Warranty

Philips provides this DOCUMENT without warranty of any kind, implied or expressed, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose.

Compliance

The Philips Medical Systems PageWriter TC20 cardiograph complies 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 Instructions 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 non-compliance, 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 TC20 cardiograph complies with the requirements of the Medical Device Directive 93/ 42/EEC and carries the mark accordingly.

Authorized EU-representative: Philips Medizin Systeme

Böblingen GmbH Hewlett Packard Str. 2 71034 Böblingen Germany

0123

Contents

ABOUT THE PAGEWRITER TC20 CARDIOGRAPH

About the Instructions for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii

Safety Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii

Symbols Marked on the Cardiograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii

Safety Symbols Marked on the Cardiograph Packaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .x

Safety and Regulatory Symbols Marked on the Cardiograph Cart. . . . . . . . . . . . . . . . . . . . . xi

Important Patient and Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii

Accessories and Supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii

AC Power Adapter and AC Power Cord. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii

Analog ECG Output Signal Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiv

Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiv

Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiv

Defibrillation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xv

Display Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xv

ECG Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xv

Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xv

General Cardiograph Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvi

IEC 60601-2-51. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvi

Main Waveform Display Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvi

Pacemaker. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvi

Patient Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii

Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii

Servicing the Cardiograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviii

Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviii

Touch Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviii

USB Memory Stick. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix

The PageWriter TC20 Cardiograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix

Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix

Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .xx

The Philips ECG Algorithm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .xx

Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .xx

Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .xx

PageWriter TC20 Cardiograph Instructions for Use i

Table of Contents

CHAPTER 1. GETTING STARTED

PageWriter TC Cardiograph Learning Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

About the PageWriter TC Cardiograph Learning Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

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

Using the Philips InCenter Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

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

PageWriter TC20 Cardiograph Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

TC20 Cardiograph. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

About the Patient Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

Attaching the Patient Cable to the TC20 Cardiograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

Working with the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10

Installing the Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10

Charging the Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

Calibrating the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

Battery Power Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13

Using the Wireless Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14

Using the USB Memory Stick . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15

Using the Barcode Reader. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16

Using the Cardiograph Touch Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16

Touch Screen Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17

Changing the Lead Format on the Main ECG Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20

The Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22

Working with Simulated Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25

Supplies, Options, and Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26

Ordering Options and Upgrades . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26

Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26

Software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-26

Cardiograph Cart and Accessories (TC30 only). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26

Cardiograph Cart and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-27

Product Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28

Contacting a Philips Response Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28

ii PageWriter TC20 Cardiograph Instructions for Use

Table of Contents

CHAPTER 2. CONFIGURING DEFAULT CLINICAL SETTINGS

Configuring the Wireless Option. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

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

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

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

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 Setup Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Configuring 12-Lead Exam Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Enabling and Disabling Simulation Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

CHAPTER 3. THE PATIENT SESSION

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

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

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

Preparing the Skin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

Electrode Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Attaching Disposable Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Attaching Welsh Bulb and Limb Clamp Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Attaching the Patient Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

Using the On/Standby Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

Entering Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

Required ID Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

Navigating on the ID Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

Entering ID Information with the Keyboard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

Selecting a Record from the Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14

Searching for Orders/ADT Updates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15

Editing ID Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16

Checking Signal Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16

Color-Coded Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17

Leads Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18

Troubleshooting Signal Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18

Identifying ECG Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19

Urgent (STAT) ECGs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21

Main ECG Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21

Changing the Lead Format on the Main ECG Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21

Taking an Auto ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23

PageWriter TC20 Cardiograph Instructions for Use iii

Table of Contents

Using the Preview Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24

Using the Last ECG Feature on the Preview Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27

Viewing Event Markers on the Preview Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28

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

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

Using Timed ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-36

CHAPTER 4. READING THE PRINTED ECG REPORT

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

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

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

About the Extreme Tachycardia Statement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4

Basic Measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

About the Fridericia and Bazett’s Formula Rate-Corrected QT Interval Setting . . . . . . . . 4-6

Patient ID Clinical Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8

Patient ID Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

Institution Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10

Configurable Clinical Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

ECG Order Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Physician Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13

Report Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14

Calibration Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15

Time Sepa rator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17

Pacing Detection Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18

Algorithm Version Number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20

Filter Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21

Artifact Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22

AC Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22

Frequency Response Filters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23

Baseline Wander Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23

Speed and Sensitivity Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24

Device Identification Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

12-Lead ECG Report Examples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26

iv PageWriter TC20 Cardiograph Instructions for Use

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ST Map Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33

12-Lead ST Map Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33

Rhythm Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36

1-Minute Disclose Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-39

Extended Measurements Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40

CHAPTER 5. CARDIOGRAPH CARE AND MAINTENANCE

Cardiograph Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

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

Patient Cable Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Approved Cleaning Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

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

Cleaning the Print Head. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

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

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

Replacing the Battery in the TC20 Cardiograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

Battery Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

Ping Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

Lead Wire Performance Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Cardiograph and Accessory Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Maintaining the Touch Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13

Touch Screen Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13

Touch Screen Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13

Changing the Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14

Replacing the Cardiograph Fuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

APPENDIX A. SUPPRESSED BORDERLINE INTERPRETIVE STATEMENTS

Philips 12-Lead Algorithm Version PH090A

Exclude Low Certainty Suppressed Statements Philips 12-Lead Algorithm Version PH090A

Exclude All Suppressed Statements

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-5

Philips DXL ECG Algorithm Version PH100B

Exclude Low Certainty Suppressed Statements Philips DXL ECG Algorithm Version PH100B

Exclude All Suppressed Statements

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-11

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-9

PageWriter TC20 Cardiograph Instructions for Use v

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APPENDIX B. CRITICAL VALUE STATEMENTS

Philips 12-Lead Algorithm Version PH090A

Acute Myocardial Infarction Critical Va lue Statements Philips 12-Lead Algorithm Version PH090A

Tachycardia Critical Value Statements Philips 12-Lead Algorithm Version PH090A

Complete Heart Block Critical Value Statements Philips DXL ECG Algorithm Version PH100B

Acute Myocardial Infarction Critical Va lue Statements Philips DXL ECG Algorithm Version PH100B

Tachycardia Critical Value Statements Philips DXL ECG Algorithm Version PH100B

Complete Heart Block Critical Value Statements Philips DXL ECG Algorithm Version PH100B

Acute Ischemia Critical Value Statements

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-9

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-6

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-7

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-10

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-11

APPENDIX C. SPECIFICATIONS

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

ECG Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-1

Keyboard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-1

Touch Screen Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-1

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

Raw Sampling Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .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-3

Printer Resolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-3

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

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

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

STEMI Diagnostic Aids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-3

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

Battery Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-4

Voltage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-4

Current. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-4

Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-4

Capacity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-4

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

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

vi PageWriter TC20 Cardiograph Instructions for Use

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Barcode Reader (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5

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

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

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

Orders and ADT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5

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

Power and Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6

Cardiograph AC Input Voltage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6

Cardiograph AC Output Voltage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6

Cardiograph Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6

Cardiograph Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6

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

Classification (IEC 60601-1). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-8

PageWriter TC20 Cardiograph Class I (Internally Powered). . . . . . . . . . . . . . . . . . . . C-8

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

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

Wireless LAN Option Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-14

INDEX

PageWriter TC20 Cardiograph Instructions for Use vii

Table of Contents

viii PageWriter TC20 Cardiograph Instructions for Use

1About the PageWriter TC20

Cardiograph

About the Instructions for Use

This PageWriter TC20 Cardiograph Instructions fo r 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 viii.

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.

vii

Safety Summary

Symbols Marked on the Cardiograph

Symbol Name Description

Attention; read the Instructions for Use

Type CF

Defibrillator Proof

Disposal Dispose of in accordance with the requirements of

Local Area Network (LAN) Connector

Attention; read the Instructions for Use

See the PageWriter TC20 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.

your country.

Connect a “shielded” Ethernet RJ45 LAN cable to the connector directly above this symbol to establish LAN connectivity.

See the PageWriter TC20 Cardiograph Instructions for Use.

Patient cable Connect the patient cable to the connector located

Wireless card icon Insert the wireless LAN card into the slot located

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

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

Standby Pressing the button with this symbol on it puts the

viii PageWriter TC20 Cardiograph Instructions for Use

directly below this symbol.

to the connector located directly above this symbol.

the cardiograph.

cardiograph into Standby (power saving mode).

Symbols Marked on the Cardiograph

Symbol Name Description

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

device.

Non-ionizing electromagnetic radiation

Equipotential Grounding Post Equipotential grounding post used for establishing

Fuse The PageWriter TC20 cardiograph contains a 1.6 amp

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

common ground between instruments.

(250V) time-delay fuse.

PageWriter TC20 Cardiograph Instructions for Use ix

Safety Symbols Marked on the Cardiograph Packaging

Symbol Description

Keep dry.

Ambient temperature range of -20

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

transport and storage.

NOTE The battery 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.

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.)

x PageWriter TC20 Cardiograph Instructions for Use

Safety Symbols Marked on the Cardiograph Packaging

Symbol Description

Dispose of in accordance with the requirements of your country.

Safety and Regulatory Symbols Marked on the Cardiograph Cart

Symbol Name Description

Cart Storage Bin Weight Limit

Optional Patient Cable Arm

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

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.

PageWriter TC20 Cardiograph Instructions for Use xi

Important Patient and Safety Information

The cardiograph isolates 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 grou nd.

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.

xii PageWriter TC20 Cardiograph Instructions for Use

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.

 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 equipment, only connect

equipment 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 perfo rmance.

 T o prevent burns to the patient , remove all ECG electrodes and and the patient cable prior

to the use of high frequency surgical equipment (including electrosurgical equipment and some respiration transducers).

AC Power Adapter and AC Power Cord

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 60601-1-1.

CAUTION The power supply could feel warm to the touch.

PageWriter TC20 Cardiograph Instructions for Use xiii

 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 cable 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 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 cardiograph) for

diagnostic 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 d oes

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 TC20 only operates with a single battery, part number 989803170371.

Cart

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

xiv PageWriter TC20 Cardiograph Instructions for Use

Defibrillation

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

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

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 60601-2-51 and AAMI EC-11 standards.

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

the Manufacturer's Disclosure Statement.

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.

CAUTION Before acquiring an ECG, ensure that the cardiograph screen does not show the DEMO MODE

data! Restart the cardiograph to exit Simulation mode. For details, see “Working with Simulated Data” on page 1-25.

Electrodes

Philips recommends the use of disposable electrodes at all times for all patient applications. Choose either adult or pediatric disposable electrodes based on the age and size of the patient.

For information on ordering disposable electrodes, see the PageWriter TC Cardiograph Service Manual, available on the PageWriter TC User Documentation CD and on InCenter.

PageWriter TC20 Cardiograph Instructions for Use xv

General Cardiograph Use

WARNING Electrical shock hazard. Keep the cardiograph and all cardiograph accessories away from

liquids. Do not immerse the cardiograph 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 cable from the cardiograph, or detach the leads from the patient prior to performing any procedure that uses high frequency surgical equipment.

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

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 1-4.

Main Waveform Display Screen

Manual measurements of ECG intervals and magnitudes should be performed on printed 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.

Pacemaker

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

xvi PageWriter TC20 Cardiograph Instructions for Use

Patient Cable

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

of the cardiograph safety features. Use of any other patient 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 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 patient cable 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.

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

( ) on the rear panel of the cardiograph.

WARNING Always clean and disinfect the patient cable after patient use, if the cable comes into

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

 Keep the patient 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 cable for any cracks or breaks in the cable insulation. If the

integrity of the patient cable is not assured, replace the patient cable. Contact Philips Medical Systems or your certified dealer for further assistance.

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.

PageWriter TC20 Cardiograph Instructions for Use xvii

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, Options, and Ordering Information” on page 1-26 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 printed ECG reports only. Do not make manual measurements of ECG intervals and magnitudes on the touchscreen display since these ECG representations are scaled.

xviii PageWriter TC20 Cardiograph Instructions for Use

USB Memory Stick

WARNING Do not use the USB memory stick to import ECGs onto the cardiograph that have been

used with other cardiographs, or other non-Philips devices.

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

Medical Systems with the 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 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 or your certified dealer for further assistance. See “Contacting a Philips Response Center” on page 1-28.

The PageWriter TC20 Cardiograph

This Philips product is 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 are 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.

PageWriter TC20 Cardiograph Instructions for Use xix

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. 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 TC20 cardiograph software uses the Philips ECG Algorithm. The algorithm in the software analyzes the morphology and rhythm on each of the 12 leads and summarizes the results. The set of summarized measurements is then analyzed by the clinically-proven ECG Analysis Program.

12-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 regardin g possible diagnosis, potential treatment, effectiveness of treatment, or to rule out causes for symptoms.

xx PageWriter TC20 Cardiograph Instructions for Use

1Getting Started

Welcome to the PageWriter TC20 cardiograph, 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 cardiograph also supports integrated connectivity with an ADT Order Update system. Powerful clinical features include the Philips DXL ECG Algorithm that provides comprehensive measurement and interpretive analysis, 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.

This PageWriter TC20 Cardiograph Instructions 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 TC20 Cardiograph Learning Kit before

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

1-1

PageWriter TC Cardiograph Learning Kit

Philips provides detailed instructional and reference materials in the PageWriter Cardiograph Learning Kit.

The PageWriter Cardiograph Learning Kit contains the Quick Help Guide, User Skills Checklists, and the PageWriter TC User Documentation DVD.

Figure 1-1 The PageWriter Cardiograph Learning Kit

About the PageWriter TC Cardiograph Learning Kit

 User Skills Checklists (A)

These checklists provide a comprehensive list of all of the tasks associated with patient preparation, taking an ECG, and using the cardiograph features. They 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 Tr ain i ng DVD.

 Quick Help Guide (B)

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 T rain ing DVD, and additional copies may be printed if necessary. The PDF file is sized appropriately for printing on standard sized paper.

 User Documentation and Training DVD (C)

The user documentation and training DVD includes many useful files including:

1-2 PageWriter TC20 Cardiograph Instructions for Use

About the PageWriter TC Cardiograph Learning Kit

– 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 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 TC Cardiograph Interactive Training Program (only available in English)

This training program provides detailed information on the purpose of 12-lead ECGs, the different views of the heart that the ECG represents, electrode placement for 12 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 1-4.

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.

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.

PageWriter TC20 Cardiograph Instructions for Use 1-3

Philips ECG XML Information

The PageWriter TC cardiograph exports ECG data in XML (Extensible Markup Language) format. There are three available XML schema versions on the cardiograph: version 1.03, version 1.04, and version 1.04.01.

For information about the Philips ECG XML schema, see the Data Dictionary and XML Schema Reference, available under the TraceMasterVue product line in InCenter.

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 Cardiograph Network Configuration Guide included on the PageWriter TC User Documentation DVD, or download the file from 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.

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

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

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

Software

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 cardiograph in active use at your facility. The serial number is found on the product identification label, located next to the text

SN. The product identification label is located on

the rear panel of the cardiograph.

Figure 1-2 Cardiograph Product Identification Label (rear view)

1-4 PageWriter TC20 Cardiograph Instructions for Use

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:

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.

www.adobe.com.

PageWriter TC20 Cardiograph Components

The following sections include a description of all of the components of the PageWriter TC20 cardiograph, including the connection ports on the cardiograp h, the patient cable, and optional accessories available with the cardiograph.

For more information on using the cardiograph features, see Chapter 3, “The Patient Session.” For information on ordering any of the optional accessories for the cardiograph, see the

PageWriter TC Cardiograph Service Manual, available on the PageWriter TC User Documentation DVD and on InCenter. For information on ordering options and upgrades, see

“Supplies, Options, and Ordering Information” on page 1-26.

PageWriter TC20 Cardiograph Instructions for Use 1-5

PageWriter TC20 Cardiograph Components

GH I J

TC20 Cardiograph

The following figures illustrate the front and back of the cardiograph.

Figure 1-3 PageWriter TC20 Cardiograph (right front view)

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

1-6 PageWriter TC20 Cardiograph Instructions for Use

Figure 1-4 PageWriter TC20 Cardiograph (rear view)

TC20 Cardiograph

A Patient cable connector D AC power cord connector B LAN connector E Card slot (with protective cover installed) C Barcode reader or magnetic card reader

F Equipotential grounding post

connector

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.

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.

PageWriter TC20 Cardiograph Instructions for Use 1-7

PageWriter TC20 Cardiograph Components

About the Patient Cable

The patient cable provides an integrated leadset and connects directly to the back of the cardiograph. For details on lead placement and checking signal quality, see Chapter 3, “The Patient Session.”

Figure 1-5 Patient cable

A Limb leads B Precordial leads

Attaching the Patient Cable to the TC20 Cardiograph

The patient cable is attached to the cardiograph through the patient data connector on the rear of the cardiograph.

WARNING The Philips patient cable (supplied with cardiograph) is an integral part of the

cardiograph safety features. Use of any other patient 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.

1-8 PageWriter TC20 Cardiograph Instructions for Use

Attaching the Patient Cable to the TC20 Cardiograph

To attach the patient cable to the cardiograph:

Connect the 15-pin connector on the patient cable to the leadset connector port ( ) located on the rear panel of the cardiograph.

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

patient cable does not drag on the ground.

PageWriter TC20 Cardiograph Instructions for Use 1-9

Working with the Battery

To disconnect the patient cable from the cardiograph:

 Loosen the connecting screws on either side of the connector and pull the connector out.

Working with the Battery

The cardiograph ships with one battery that powers the cardiograph when AC power is not available.

CAUTION Before plugging the cardiograph into AC power, insert the battery into the cardiograph.

Installing the Battery

NOTE The TC20 cardiograph operates with a single battery, part number 989803170371.

To install the battery:

Open the battery door.

1-10 PageWriter TC20 Cardiograph Instructions for Use

Installing the Battery

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

battery compartment and lay flat.

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

4 Push in the battery and ensure that the battery is fully inserted into the slot. The gold pull

tab will insert along with the battery.

5 Reinstall the battery door.

PageWriter TC20 Cardiograph Instructions for Use 1-11

Working with the Battery

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

operating the cardiograph on battery power only.

Charging the Battery

Charge the battery for five hours prior to initial use. After initial charging, plug the cardiograph into AC power whenever possible, and ensure that the battery is fully recharged. Proper battery maintenance and care, including frequent and full recharging of the battery, 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.

Calibrating the Battery

The battery may require periodic calibration to ensure the continued accuracy of the battery power and overall battery status information displayed on the cardiograph. If battery calibration is necessary, the message Information window. For more information on battery calibration, see “Battery Calibration” on page 5-10.

Recommend Calibration appears on the Battery Status

1-12 PageWriter TC20 Cardiograph Instructions for Use

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 1-6 Battery Power Indicator on the Status Bar

A Battery level indicator

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 single installed cardiograph battery, or of the two installed batteries. The battery icon located on this screen indicates the charge status of the available battery power.

Table 1-1 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:

 The Red battery icon appears when power level is below

25%.

 The cardiograph beeps and an error message appears until

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

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

operating battery power.

No or Dead Battery

PageWriter TC20 Cardiograph Instructions for Use 1-13

Using the Wireless Connection

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

immediately.

Figure 1-7 Battery Status Information with Plug in the Cardiograph message

Touch the Close button to close the window.

Using the Wireless Connection

The TC20 cardiograph supports the AmbiCom wireless option. The wireless option allows the transfer of ECG and order/patient demographic data between

the cardiograph and a TraceMaster ECG Management System or ECG Gateway server. 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, see the PageWriter TC Cardiograph Network Configuration Guide available on the PageWriter TC User Documentation DVD, or the file can be downloaded from the Philips InCenter site.

CAUTION Only use appropriate wireless LAN devices with the cardiograph that have been purchased from

Philips. The use of non-approved wireless LAN deviecs with the cardiograph is not tested or supported, and Philips does not guarantee cardiograph operation or wireless LAN connectivity.

For information on installing the option and configuring the cardiograph for wireless transmission, see the PageWriter TC Wireless LAN Installation Instructions. The file is provided with the Wireless kit, and is also available for download from the Philips InCenter

incenter.medical.philips.com).

site ( For information on ordering the wireless option, see “Supplies, Options, and Ordering

Information” on page 1-26.

1-14 PageWriter TC20 Cardiograph Instructions for Use

Battery Power Indicator

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 as either XML files or as PDF files. 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. This guide is available for download from the Philips InCenter site. For details, see “Using the Philips InCenter Site” on page 1-4.

CAUTION The PageWriter TC cardiograph only supports the USB memory stick that is available for purchase as

an optional accessory from Philips. Philips does not guarantee that other USB memory sticks are compatible with the PageWriter TC cardiograph.

Figure 1-8 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. Ensure that the USB memory stick is firmly inserted into the USB connector. The tip of the USB memory stick illuminates when it is properly inserted into the USB connector.

CAUTIONS  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.

 Only use the USB memory stick to transfer data between a PageWriter cardiograph and a

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

PageWriter TC20 Cardiograph Instructions for Use 1-15

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, Options, and Ordering Information” on page 1-26.

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

using the barcode scanner, is included on the PageWriter TC User Documentation DVD.

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.

1-16 PageWriter TC20 Cardiograph Instructions for Use

Touch Screen Overview

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. See the figure on the next page.

Figure 1-9 Touch Screen Overview (with 12x1 lead format)

Table 1-2 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 and Timed ECG.

 Touch the button to change the selected Exam

Type.

PageWriter TC20 Cardiograph Instructions for Use 1-17

Using the Cardiograph Touch Screen

Table 1-2 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 interpretive 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, and the current date and time.

1-18 PageWriter TC20 Cardiograph Instructions for Use

Waveform Display

toolbar

Help

 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.

Table 1-2 Touch Screen Overview (continued)

Touch Screen Item Feature Description

Touch Screen Overview

Setup

ECG Storage and Management Features

Rhythm and Disclose Features

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.

 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 (10) displays the

number of ECGs currently stored in the Archive.

 The Rhythm feature is used to print continuous

rhythm strips of up to 12 selected leads until

Stop button is touched.

the

 The Disclose feature is used to review captured

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 (5) displays

the number of Events currently stored in Disclose for the current patient session.

1-2-3 Operation Features

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

PageWriter TC20 Cardiograph Instructions for Use 1-19

Using the Cardiograph Touch Screen

Changing the Lead Format on the Main ECG Screen

The format of the waveforms that display on the Main screen can be changed at any time. The available lead formats are described in Table 1-3.

Table 1-3 Main Screen Lead Formats

Lead Format Description

6x2

12x1

3x4

 This is the default lead format on the cardiograph.  This view provides five seconds of continuous ECG

waveform data for each lead on a split screen.

 In the split screen display , the l imb and augmented leads

on the left, and the precordial leads are on the right.

 See Figure 1-10 on page 1-21.

 This view provides ten seconds of continuous ECG

waveform data for each lead.

 See Figure 1-9 on page 1-17.

 This view provides 2.5 seconds of waveform data for

each lead, with 3 total rows with 4 leads in each row.

 In this view, the limb and augmented leads are on the

left, and the precordial leads are on the right.

 See Figure 1-11 on page 1-21.

1-20 PageWriter TC20 Cardiograph Instructions for Use

Changing the Lead Format on the Main ECG Screen

Figure 1-10 Default 6x2 Lead Format on Main Screen

A Limb Leads B Precordial Leads

Figure 1-11 3x4 Lead Format on Main Screen

PageWriter TC20 Cardiograph Instructions for Use 1-21

Using the Cardiograph Touch Screen

ABCDEFG

JIH

To change the lead display on the main screen:

Press the down arrow key (on keyboard) or the up arrow key to scroll through the available Main screen lead formats.

4 The lead format that displays on the Main screen when the cardiograph is shut down (by

pressing and holding the On/Standby button ( ) will be retained once the cardiograph is returned to active use.

The Status Bar

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

Figure 1-12 The Status Bar

Table 1-4 The Status Bar

Status Bar Item Feature Description

Selected Exam Type

 The Exam T ype selected for the current patient

session.

 The available Exam Types are:

Resting 12-Lead and Timed ECG.

ECG Layout

 The current ECG report layout settings,

including the level of interpretation generated by the Philips interpretive algorithm.

 Any of the settings on this screen may be

edited for the current patient session.

Operating Settings

 The current selected filters (Artifact, Baseline

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

 The Unknown pacing setting is recommended

for most ECGs.

1-22 PageWriter TC20 Cardiograph Instructions for Use

Table 1-4 The Status Bar (continued)

Status Bar Item Feature Description

The Status Bar

Event Marker Alert

Caps Lock

LAN and Wireless LAN Connectivity

 If this flashing icon appears, saved Event

markers ( ) have not yet been reviewed on the Disclose screen, and will be deleted within the next 3 minutes.

 Touch the Disclose button on the toolbar to

review these saved Events.

 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 ( ).

Battery Power Indicator

Wireless LAN connectivity

 Indicates the signal strength of 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.

 Gray bars indicate that the wireless adapter is

unable to associate to an access point.

 Displays the available battery power. For more

information, see “Battery Power Indicator” on page 1-13.

PageWriter TC20 Cardiograph Instructions for Use 1-23

Using the Cardiograph Touch Screen

Table 1-4 The Status Bar (continued)

Status Bar Item Feature Description

Date and Time

Heart Rate Indicator

 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

1-24 PageWriter TC20 Cardiograph Instructions for Use

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

Working with Simulated Data

The cardiograph offers a simulation mode in which cardiograph displays simulated waveforms on every screen, as well as on printed reports. This mode may be useful when training users on cardiograph operation.

The Status Bar

When simulated waveforms are enabled:

 No data is acquired from the patient  The Patient ID field is set to Simulated data (appears on the screen, in the status bar, and on

printed reports)

 A large watermark with the text Demo Mode appears on the screen and on printed reports  Returning from standby keeps the cardiograph in Simulation mode  After it is initially enabled, restarting the cardiograph ends simulation mode; after a

restart, the cardiograph is in real-data acquisition mode. To return to simulation mode, you must re-enable it in the settings.

For configuration details, see “Enabling and Disabling Simulation Mode” on page 2-7.

PageWriter TC20 Cardiograph Instructions for Use 1-25

Supplies, Options, and Ordering Information

For the list of cardiograph supplies available, refer to the PageWriter TC Cardiograph Service Manual, available on the PageWriter TC User Documentation DVD and on InCenter. For

details, see “Using the Philips InCenter Site” on page 1-4. All supplies may be ordered on the web at: For additional assistance, contact your Philips Sales Representative or your local distributor.

http://shop.medical.philips.com

Ordering Options and Upgrades

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

Hardware

Option Number Description

A02 Cardiograph only

H12 Barcode Reader

H13 Magnetic Card Reader

H14 Smart IC Card Reader

H23 Long Patient Cable

Software

Option Number Description

D01 Networked Worklists/Patient List Support

D02 ADT Support

D03 DXL 12-Lead ECG Algorithm

D05 5-min Disclosure and Events

D06 Archive, Last ECG, and Interactive Query

D07 Manual Worklists/Patient List Support

1-26 PageWriter TC20 Cardiograph Instructions for Use

Software

Option Number Description

D20 Wired LAN Connectivity

D23 Wi-Fi 802.11 (b,g)

Accessories

Option Number Description

E01 Alligator Clips

E02 Wide Tab with Snap

Ordering Options and Upgrades

E03 Pediatric Lead Extenders

E04 Welsh Bulbs

E06 Double-sided Tab Clips, compatible with both tab and snap

electrodes

Warranty

Option Number Description

W03 3 year return to Philips Bench

W05 5 year parts and support by certified dealer

PageWriter TC20 Cardiograph Instructions for Use 1-27

Product Troubleshooting

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

downloaded from the Philips InCenter site. For details, see “Using the Philips InCenter Site” on page 1-4.

This document provides comprehensive information on product troubleshooting, performance verification and safety tests, using the Service Utilities accessed from the installing software upgrades. The Service Manual is only available in English. For more comprehensive information on product troubleshooting, contact the nearest Philips Response Center or your certified dealer 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 cardiograph or any of its accessories.

Setup menu, and

For more information, go to:

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

North America 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 Centers

Country Telephone Number

Argentina 54 11 4546 7698

Brazil 0800 701 7789

Chile 0800 22 3003

1-28 PageWriter TC20 Cardiograph Instructions for Use

South America Centers

Country Telephone Number

Columbia 01 8000 11 10 10

Peru 51 1 620 6440

Europe Centers

Country Telephone Number

United Kingdom 44 0870 532 9741

Fax: 44 01737 23 0550

Austria 43 1 60 101 820

Ordering Options and Upgrades

Belgium 32 2 525 7103 (French)

32 2 525 7102 (Flemish)

Czech Republic 31 40 2781619

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

Hungary 31 40 2781619

Italy 0800 232100

Netherlands 31 40 27 211 27

Norway 47 800 84 080

Poland 31 40 278161 9

Rumania 31 40 2781619

PageWriter TC20 Cardiograph Instructions for Use 1-29

Contacting a Philips Response Center

Europe Centers

Country Telephone Number

Russia 31 40 2781619

Slovak Republic 31 40 2781619

Spain 34 90 230 4050

Sweden 46 200 81 00 10

Switzerland 0800 80 3000 (German)

Australia and Asia Centers

0800 80 3001 (French)

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

1-30 PageWriter TC20 Cardiograph Instructions for Use

Africa and Middle East Centers

Country Telephone Number

All countries 31 40 2781619

Ordering Options and Upgrades

PageWriter TC20 Cardiograph Instructions for Use 1-31

Contacting a Philips Response Center

1-32 PageWriter TC20 Cardiograph Instructions for Use

1Configuring Default Clinical Settings

All of the settings on the PageWriter TC 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

Setup screens.

Configuring the Wireless Option

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

the Philips InCenter web site ( InCenter web site, see page 1-4.

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

Password Access

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

2-1

Configuration with a Philips TraceMaster ECG Management System

For information on configuring networking and other settings on the cardiograph 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 PageWriter TC User Documentation DVD, or download the file from the Philips InCenter web site ( InCenter site, see page 1-4.

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

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 page 1-4.

(

Restoring Custom Configuration Settings

After configuring the cardiograph, save the settings to a USB memory stick, or to a configured shared remote computer 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, or from a configured shared remote computer. For information on configuring a shared remote computer, see the PageWriter TC Cardiograph Network Configuration Guide.

To save custom settings, touch the and the provided directly on this screen. For information on using the Setup Help, see “Using Setup Help” on page 2-5.

Save/Load button (top of screen). Instructions on how to save custom settings is

Setup button, Configure Cardiograph Default Settings,

Configuring Multiple Cardiographs

When configuring multiple cardiographs with the same TraceMaster and OrderVue settings, you can save all settings to a USB memory stick, or to a remote shared computer, and then upload them to additional TC cardiographs.

NOTE Wireless LAN settings are saved with the network settings .DAT file.

2-2 PageWriter TC20 Cardiograph Instructions for Use

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

Tips for Creating Secure Passwords

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, including Simulation mode.

 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 Chapter 5, “Cardiograph Care and Maintenance.”

PageWriter TC20 Cardiograph Instructions for Use 2-3

Opening the Setup Screens

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

Menu Item Feature Description

Configure ECG Network Settings

Service Utilities

Upgrade Kit Installation and Software Updates

 Touch to configure TraceMaster, ECG

Gateway, OrderVue, or third-party ECG management system settings.

 Touch to configure wired and wireless

LAN connectivity.

 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.

 For more information on using the Service

Utilities, see the PageWriter TC Cardiograph Service Manual (only

available in English).

 Touch to access software updates and to

add options.

 See the PageWriter TC Cardiograp h

Service Manual (only available in English

2-4 PageWriter TC20 Cardiograph Instructions for Use

Using Setup Help

Each Setup 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.

When a Setup screen is opened, Help displays in a blue Information box that appears on the screen. Touch the option displayed on the screen to display Help for that specific item.

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 on the screen (see Figure 2-2 on page 2-5).

2 Touch the Close button when done.

Figure 2-2 Help displayed on a Setup screen

Tips for Creating Secure Passwords

Close button when done. Touch a tab, or touch the name of any field or

A Setup Help window

PageWriter TC20 Cardiograph Instructions for Use 2-5

Configuring 12-Lead Exam Settings

The Exam setup wizard is used to specify ECG operating settings, and 12-lead ECG report settings. Each set of defined settings is saved as an individual Exam Profile that is given a unique name. This Exam Profile can then be selected during a patient session.

To configure 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).

Figure 2-3 The Exams Setup screen

A Exams button selected

Manage Exams tab selected

C Edit Exams dropdowns

Touch a button under Create a New Exam to begin creating a new Exam for Resting

12-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

2-6 PageWriter TC20 Cardiograph Instructions for Use

Next button to continue.

Tips for Creating Secure Passwords

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

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 DXL ECG algorithm. Touch the

NOTE 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 details, see “Extended Measurements Report” on page 4-40.

The following screen specifies the Rhythm leads and the waveform speed and scale

Next button to continue.

settings for all Rhythm reports printed using this Exam Profile.

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

button when complete.

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

OK. The Exam Profile is now saved and may be selected during a patient session. The

new Exam Profile settings may also be edited. Select the Exam Profile from the

dropdown menus on the main Manage Exams screen. See Figure 2-3, “The Exams

Exam

Edit an

Setup screen,” on page 2-6.

Enabling and Disabling Simulation Mode

For details on Simulation mode, see “Working with Simulated Data” on page 1-25.

To enable Simulation mode

On the Default Cardiograph Settings screen, touch the System button.

2 In the Simulation Mode field, touch the OFF/ON button.

When the button shows

3 Touch the Exit button to exit Setup, and to confirm your changes. 4 Touch OK to restart the cardiograph.

A restart is required to change the Simulation mode setting.

NOTE After it is initially enabled, restarting the cardiograph ends simulation mode; after a restart, the

cardiograph is in real-data acquisition mode.

ON, Simulation mode is enabled.

PageWriter TC20 Cardiograph Instructions for Use 2-7

Enabling and Disabling Simulation Mode

To disable Simulation mode

 Restart the cardiograph.

The cardiograph automatically restarts in real-time acquisition mode after a restart (after initially enabling the option).

2-8 PageWriter TC20 Cardiograph Instructions for Use

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 DVD, or download the file from the Philips InCenter site incenter.medical.philips.com.

 Before acquiring an ECG, ensure that the cardiograph screen does not show the DEMO MODE

watermark on the waveform screen or report, and the Patient ID does not display the text, Simulated data. If these elements are present, the cardiograph is in Simulation mode and is not acquiring patient data! Restart the cardiograph to exit Simulation mode. For details, see “Working with Simulated Data” on page 1-25.

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...

Prepare the patient for the procedure. “Patient Preparation” on page 3-4.

3-1

Introduction

Table 3-1 The Patient Session (continued)

The Patient Session

2 Prepare the electrode sites and attach the

 “Preparing the Skin” on page 3-5.

electrodes.

 “Electrode Placement” on page 3-6.  “Attaching Disposable Electrodes” on

page 3-9.

 “Attaching Welsh Bulb and Limb Clamp

Electrodes” on page 3-9.

3 Attach the patient cable. “Attaching the Patient Cable” on page 3-11.

Enter Patient Information or Take a STAT ECG

Step Description More Information See...

2  Take an urgent/STAT ECG

Check the Signal Quality

Return the cardiograph to active use. “Using the On/Standby Button” on page 3-12.

 “Urgent (STAT) ECGs” on page 3-21.

 Enter patient information or select an order

from the Worklist

 “Entering Patient Information” on

page 3-13.

Step Description More Information See...

When the patient is connected to the

“Checking Signal Quality” on page 3-16. cardiograph, color-coded ECG waveforms appear on the Main screen. Check the signal quality.

2 Touch the Map button on the cardiograph to

“Leads Map” on page 3-18. verify electrode and lead connections.

3-2 PageWriter TC20 Cardiograph Instructions for Use

Table 3-1 The Patient Session (continued)

The Patient Session

Select an ECG Acquisition Mode

Step Description More Information See...

Do any of the following:

 Capture Events for review on the Disclose

screen

 Print an Auto ECG “Main ECG Screen” on page 3-21.

 Print a Rhythm report “Rhythm ECG Acquisition” on page 3-30.

 Use the Disclose feature to:

“Capturing Events from the Main or Rhythm

Screens” on page 3-33.

“Disclose ECG Acquisition” on page 3-33.

– Review Events captured on the Main or

Rhythm screens

– Print a 12-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 patient waveform data for a

selected Disclose lead

 Use the Timed ECG feature to take ECGs at

“Using Timed ECG” on page 3-36.

preset intervals

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

Step Description More Information See...

Compare the most recent ECG from the same patient using the optional

Last ECG feature

 “Using the Last ECG Feature on the

Preview Screen” on page 3-27.

(requires an active TraceMaster connection)

 “Critical Values on Preview Screen” on

page 3-29.

PageWriter TC20 Cardiograph Instructions for Use 3-3

Patient Preparation

Table 3-1 The Patient Session (continued)

The Patient Session

End the Patient Session

Step Description More Information See...

Disconnect the patient.

The patient session ends when:

 New patient information is entered or a new pending order is selected  The cardiograph enters Standby or is shut down  The patient is disconnected or leads are off for more than 10 seconds  Archive or Setup are selected

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.

3-4 PageWriter TC20 Cardiograph Instructions for Use

Preparing the Skin

Once the electrodes and patient cable 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.

PageWriter TC20 Cardiograph Instructions for Use 3-5

Patient Preparation

Electrode Placement

Review the following lead 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/C2 and V4/C4

Left midclavicular line in the 5th intercostal space

Anterior axillary line at the same level as V4/C4

Left midaxillary line at the same level as V4/C4

3-6 PageWriter TC20 Cardiograph Instructions for Use

Figure 3-1 Male Standard 12-Lead Electrode Placement (AAMI/IEC)

V3/C3

V4/C4

V5/C5

V6/C6

LA/L

LL/FRL/N

RA/R

V1/C1

V2/C2

Electrode Placement

PageWriter TC20 Cardiograph Instructions for Use 3-7

Patient Preparation

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)

3-8 PageWriter TC20 Cardiograph Instructions for Use

Attaching Disposable Electrodes

For the best quality ECG, ensure that all skin preparation procedures described in “Preparing the Skin” on page 3-5 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.

Attaching Welsh Bulb and Limb Clamp Electrodes

Special Note about Welsh Bulb Electrodes

Special care is necessary when using Welsh Bulb electrodes. Pay special attention to all warning associated with these electrodes. For information on cleaning the reusable Welsh Bulb electrodes, see “Reusable Electrode Cleaning” on page 5-5. Philips recommends the use of disposable electrodes at all times with the PageWriter TC 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 5-5 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 TC20 Cardiograph Instructions for Use 3-9

Patient Preparation

The Welsh Bulb electrode is a self-restraining electrode that consists of a rubber squeeze bulb and a metal cup. The rubber squeeze bulb provides sufficient suction to hold the electrode firmly on the patient without causing discomfort. This electrode is used on the chest. The limb clamp electrodes are used on the arms and legs. Philips recommends the application of highly conductive multipurpose electrolyte gel to the electrode site whenever Welsh Bulb and limb clamp electrodes are used.

Figure 3-3 Welsh Bulb and Limb Clamp Electrode

For the best quality ECG, ensure that all skin preparation procedures described in “Preparing the Skin” on page 3-5 have been followed.

To attach limb clamp and welsh bulb electrodes:

Expose the arms and legs of the patient (to place the limb plate electrodes).

2 Inspect both the limb clamp and the Welsh Bulb electrodes to ensure that both are clean.

For information on cleaning reusable electrodes, see “Reusable Electrode Cleaning” on page 5-5.

3 Ensure that the patient cable and the lead wires are not twisted, and lay the patient cable

flat.

4 Connect the lead wire to the corresponding electrode, this may be done one electrode at a

time for convenience.

5 Apply a thin layer of electrolyte gel to the area of the skin where the electrode will be

applied. The skin area covered by the electrolyte gel should not exceed the diameter of the electrode.

3-10 PageWriter TC20 Cardiograph Instructions for Use

Attaching the Patient Cable

6 Rub the electrode on the skin with a circular motion to apply and spread the electrolyte gel

to the electrode surface and skin. This is very important if the patient’s skin is extremely dry . If the patient’ s skin is excessively hairy, follow the procedure “Preparing the Skin” on page 3-5 to remove hair from electrode sites.

CAUTION When applying the precordial electrodes, do not overlap the electrolyte gel of adjacent electrode

sites. Overlapping electrolyte gel will cause interaction between electrode sites, and may result in distortion of the ECG signal.

7 Hold the electrode on the patient’s skin and depress the top of the rubber bulb. 8 Release the rubber bulb, and the electrode attaches to the patient. 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.

TIPS  Place the electrodes on flat, fleshy parts of the arms and legs.

 Place the electrodes on the inside of each arm (between the wrists and elbows).

 Place the electrodes on the inside of each calf (between the knee and the ankle).

 Place the limb electrodes equal distance from the heart. Position the electrodes at the same

place on each limb.

 If a limb site is not available (amputation, injury) place the electrodes closer to the torso.

To remove limb clamp and welsh bulb electrodes:

 Detach the rubber bulb from the metal cup by pulling. Follow the procedure, “Reusable

Electrode Cleaning” on page 5-5, to clean reusable electrodes after each use.

Attaching the Patient Cable

Each lead wire tip is labeled and color-coded for easy identification.

To attach the patient cable:

 Attach each lead wire to the corresponding electrode.

PageWriter TC20 Cardiograph Instructions for Use 3-11

Using the On/Standby Button

The On/Standby button is used to:

 Put the cardiograph into Standby when not i n active use in order to conserve battery power  Shut down all power to the cardiograph for extended periods of inactivity  Return the cardiograph to active use

CAUTION Ensure that all patient data from an active patient session is saved before entering Standby, or

shutting down the cardiograph. Unsaved patient data (patient identification information, unreviewed Event Markers, unsaved ECGs) is deleted when the cardiograph enters Standby.

Figure 3-4 The On/Standby button

A On/Standby button

To put the cardiograph into Standby (power save):

Press the On/Standby button gently to put the cardiograph into Standby. When the cardiograph is in Standby, the screen is black.

TIP Plug the cardiograph into AC power whenever possible to recharge the batteries.

Press the On/Standby button again to return the cardiograph to active use. The previously viewed screen (prior to entering Standby) appears.

NOTE If the Disclose or Rhythm screens are viewed prior to entering Standby, the Main screen will

appear when the cardiograph is returned to active use.

3-12 PageWriter TC20 Cardiograph Instructions for Use

To shut down the cardiograph:

Press and hold the On/Standby button for 3 seconds to shut down the cardiograph. When the cardiograph is shut down, any unsaved patient data is lost.

2 Press the On/Standby button to return the cardiograph to active use. The cardiograph fully

restarts and the Main screen appears.

Entering Patient Information

Patient information is entered by:

 Keyboard  Selecting a pending order  Barcode reader (optional)  Magnetic card reader (optional)

Required ID Information

 Smart card reader (optional)

Required ID Information

Required patient information is indicated in blue type on the ID screen. This information must be complete in order to transmit an ECG (as either an XML or PDF file) from the Archive to a TraceMaster ECG Management System, or to a USB memory stick. The ID fields that are required are designated by your supervisor.

Navigating on the ID Screen

 To move to the next field on the screen, press the Tab key (on keyboard).  T o move to the previous field on the screen, press and hold the Shift key (on keyboard) and

then press the Tab key.

Entering ID Information with the Keyboard

To enter ID information with the keyboard:

Touch the ID button on the Toolbar. The ID screen appears. The New Patient tab (top of screen) is selected. Patient information is entered under this tab. Fields in blue are required (if configured) and must be completed.

NOTE A message appears if the ID screen is exited before completing the required patient information

fields.

PageWriter TC20 Cardiograph Instructions for Use 3-13

Entering Patient Information

2 Enter the information. Press the Tab key (on keyboard) to scroll between the different

fields.

NOTE Do not add any spaces to the ID number field if transferring ECGs to a TraceMaster ECG

Management System.

Touch OK when done.

Selecting a Record from the Worklist

Any record contained in the Worklist may be selected for a patient session. Records are downloaded to the cardiograph from a specified TraceMaster Remote Site through an inbox configured for use on the cardiograph.

To select a pending record for a patient session:

Touch the ID button.

2 Touch the Worklist tab (top of screen). The selected tab is highlighted in blue. The

Worklist screen appears.

NOTE The number that displays on the Worklist tab (10) indicates how many pending records are

available in the Worklist.

The records available in the W orklist appear on the screen. Orders are shown in black text, patient records (ADT) are shown in blue text.

3 Touch a record to select it. The selected record is highlighted in blue. 4 Touch the Select button (lower right corner of screen) to select the highlighted record for

the current patient session. The Main screen appears with the patient information for the selected order appearing on the Status Bar (top of screen).

3-14 PageWriter TC20 Cardiograph Instructions for Use

Searching for Orders/ADT Updates

You can search for records in any inbox that is available on the cardiograph. Or, you can search for a record during an active patient session by using data scanned from a

barcode reader, magnetic card reader, or from a Smart Card reader. The cardiograph must be connected to the network in order to use the search feature.

To search for records:

Touch the ID button. The ID screen appears.

2 Touch the Find Patient tab (top of screen). The selected tab is highlighted in blue. 3 The Location dropdown list (top left of screen) contains all of the available search

locations for the cardiograph. To uch the dropdown arrow button to open the list. Touch a location to select it. The selected location appears highlighted in blue and the list closes.

NOTE Worklist is the internal cardiograph pending order and/or patient record list.

Enter search data into the available fields including Patient ID, Last Name, First Name,

Date of Birth, and Room (number).

The entered information will be used to search for records. To search using data entered from an external device (barcode reader, magnetic card reader, Smart Card reader), place the cursor in the field in which the data is to be scanned. Scan the data. The data appears in the field.

TIP Enter the wildcard character (*) into any field to broaden the search information. For example, to

search for orders for all patients with the last name of Doe, enter Doe into the Last Name field, and enter * into the First Name field.

The selectable optional search field is located at the upper right of the screen.

This available optional search field includes the following options:

Account Number, Gender, Unit Number or Priority (STAT).

ADT patient information includes

Encounter ID, and Bed Number.

6 Touch the dropdown arrow to open the list of optional search fields. Touch an optional

Account Number, Gender, Unit Number,

Order Number,

search field to select it. Then, enter search data into the field.

7 When all patient information to be used in the search is entered, touch the Find button

(bottom of screen). The Message Bar (bottom of screen) displays the search status. Any records that match the entered search data appear in the orders list.

8 Touch a record to select it. The selected record appears highlighted in blue. To select the

highlighted record for the current patient session, touch the

Select button (bottom of

screen).

NOTE Touch the Cancel button to exit the screen without saving the record.

PageWriter TC20 Cardiograph Instructions for Use 3-15

Checking Signal Quality

Editing ID Information

Patient information may be edited at any time during a patient session, or may be edited for a single ECG on the Archive screen. A message appears if changes made to patient information could affect ECG interpretation.

Changes to patient information are applied to all ECGs taken during an active patient session, or to a single ECG stored in the Archive.

To edit ID information:

From the Archive only, touch the saved ECG that you wish to edit. The selected item is highlighted in blue.

2 From the Main screen, or from the Archive, touch the ID button. The ID screen appears. 3 From the Archive, the Edit Patient ID tab is automatically selected, or touch this tab to

select it. The selected tab is highlighted in blue.

4 Edit the ID information displayed on the screen. Press the Tab key (on keyboard) to scroll

between the different fields.

5 Touch OK to save the edits.

Touch

Cancel to exit without saving the edits.

Checking Signal Quality

The signal quality of each lead is indicated by the color of the lead as displayed on the screen. In addition to the color-coded signal quality indicators, there are additional signal quality features available on the cardiograph. If the signal quality of all leads is good, and all required patient information has been entered, the indicating that the ECG is ready to be taken. Also, the loose or disconnected leads or electrodes. When the appears and any loose or disconnected leads are indicated with a red x mark ( ).

Finally, when using the Philips DXL ECG Algorithm, the cardiograph also detects the one of 20 lead reversals. After you press the ECG button, if detected, an alert message appears on the screen indicating one of the following conditions:

V1-V2 swapped V1-V3 swapped V1-V4 swapped V1-V5 swapped V1-V6 swapped V2-V3 swapped

ECG button (front panel of cardiograph) illuminates,

Map button can be used to check for any

Map button is touched, a lead diagram

V2-V4 swapped V2-V5 swapped V2-V6 swapped V3-V4 swapped V3 V5 swapped V3-V6 swapped V4-V5 swapped V4 V6 swapped V5-V6 swapped

3-16 PageWriter TC20 Cardiograph Instructions for Use

Color-Coded Waveforms

LA-LL swapped LA-RA swapped RA-LL swapped LA-LL-RA swapped (counter-clockwise rotation) LA-RA-LL swapped

(clockwise rotation)

For information on troubleshooting signal quality issues, see “Troubleshooting Signal Quality” on page 3-18.

Color-Coded Waveforms

When the patient cable is attached to the patient (with the cardiograph turned on), waveforms appear on the Main ECG screen. The color of the waveform indicates the signal quality of the individual lead.

Table 3-3 Waveform Quality Indicators

Waveform Color Indicates... Possible Causes

Green waveform

Yellow waveform

Orange waveform

 Good connection

 Moderate noise level, artifact,

electrical interference, or a poor electrode connection

 ECG quality will be affected

 Severe artifact, electrical

interference, or a poor electrode connection

 One or more limb leads are

disconnected (chest leads display in orange)

 Inadequate patient

preparation

 Electrical interference

from another device

 Moderate patient

movement, tense patient

 Improperly gelled

electrode (dried gel)

 Electrical interference

from another device

 Patient tremors, shivering

patient, inadequate preparation

 Very poor electrode

contact, dry electrodes

PageWriter TC20 Cardiograph Instructions for Use 3-17

Checking Signal Quality

Table 3-3 Waveform Quality Indicators (continued)

Waveform Color Indicates... Possible Causes

Red dotted line

 Loose electrode connection  ECG waveform data that cannot

be analyzed

 Inoperative electrode,

electrode that has fallen off the patient

 Defibrillation has been

performed too recently to take ECG measurements

 Other cause that renders

waveform data useless

Leads Map

The Leads Map is a graphical representation of a patient that shows the location of loose or inoperative electrode(s). The Leads Map is available on the Main screen only.

To open the Leads Map:

On the Main screen, touch the Map button on the Toolbar.

2 The location of a loose or inoperative electrode is indicated with a red x mark ( ).

Troubleshooting Signal Quality

Always follow good skin and patient preparation techniques prior to taking an ECG. Proper skin preparation helps to ensure a good quality ECG. Skin is a poor conductor of electricity and frequently creates artifact that distorts the ECG signal. For more information, see “Patient Preparation” on page 3-4.

A dotted line, known as a “leads off” trace will appear on the display when there is a poor connection between the electrode and the patient.

Use the following table to identify and correct the connection:

Figure 3-6 Identification of Leads Off Connections

Symptom Check Electrode

All 12 leads show discontinuities or dashed lines

All leads except I show discontinuities or dashed lines

RL or N (right leg) electrode or cable wire

LL or F (left leg) electrode or cable wire

3-18 PageWriter TC20 Cardiograph Instructions for Use

Figure 3-6 Identification of Leads Off Connections (continued)

Symptom Check Electrode

Identifying ECG Problems

All leads except II show

LA or L (left arm) electrode or cable wire

discontinuities or dashed lines All leads except III show

RA or R (right arm) electrode or cable wire

discontinuities or dashed lines Any combination of chest (V) leads

Indicated chest (V) electrodes or cable wires

shows discontinuities or dashed line

Identifying ECG Problems

The following table shows symptoms and solutions to problems that can occur when recording an ECG.

Figure 3-7 ECG Problems and Solutions

Symptom Cause Possible Solutions

Power line AC Interference Poor electrode contact. Dry

or dirty electrodes.

Abrade skin. Use new electrodes. Reapply electrodes. Check expiration date on disposable electrodes.

The patient cable may be picking up interference from poorly grounded equipment near the patient.

Patient cable is too close to the cardiograph or other power cords.

Route lead wires along limbs and away from other electrical equipment. Fix or move poorly grounded equipment.

Move cardiograph away from the patient. Unplug the cardiograph and operate on battery only. Move other electrical equipment away from patient. Unplug electric bed.

PageWriter TC20 Cardiograph Instructions for Use 3-19

Checking Signal Quality

Figure 3-7 ECG Problems and Solutions (continued)

Symptom Cause Possible Solutions

Wandering Baseline Patient movement.Electrode

movement.

Poor electrode contact and skin preparation.

Respiratory interference.

Tremor or Muscle Artifact Poor electrode placement.

Poor electrode contact. Patient is cold.

Tense, uncomfortable patient.

Reassure and relax the patient.

Be sure that the lead wires are not pulling on the electrodes. Reapply electrodes. Enable the Wander filter (

Status Bar > Settings).

Move lead wires away from areas with the greatest respiratory motion.

Clean the electrode sites. Reapply electrodes. Be sure the limb electrodes are placed on flat, non-muscular areas. Warm the patient.

Reassure and relax the patient. Enable the Artifact filter (

Settings

Status Bar >

Tremors.

Intermittent or Jittery Waveform Poor electrode contact. Dry

electrodes.

Faulty patient cable.

Poor print quality (uneven

Dirty printhead. Clean the printhead.

contrast or blank streaks)

Attach the limb electrodes near the trunk. Enable the Artifact filter.

Clean the electrode site. Reapply electrodes. Check expiration date on disposable electrodes.

Replace faulty patient cable.

Use recommended paper.

3-20 PageWriter TC20 Cardiograph Instructions for Use

Changing the Lead Format on the Main ECG Screen

Urgent (STAT) ECGs

Patient information does not have to be entered in an emergency situation in order to take an ECG.

Complete all patient information after the urgent ECG is taken, but before the patient session ends. All required patient information fields must be completed in full in order to transfer an ECG to a TraceMaster ECG Management System or to a USB memory stick (as either an XML or PDF file).

To take an emergency or STAT ECG:

From the Main screen, check that all leads have a good connection.

2 When all leads have a good connection, touch the green ECG button on the front of the

cardiograph twice rapidly.

3 The ECG automatically prints and appears on the Preview screen.

NOTE If no patient information is entered a statement is included on the ECG that interpretation used a

default age (50 years) and gender (male). The default age and gender that appear on the ECG report is specified by your supervisor.

Main ECG Screen

The Main ECG screen displays live patient ECG data in a variety of formats. The Main ECG screen is the default screen that appears when the cardiograph is restarted.

Changing the Lead Format on the Main ECG Screen

The format of the waveforms that display on the Main screen can be changed at any time. The available lead formats are described in Table 3-5.

Table 3-5 Main Screen Lead Formats

Lead Format Description

6x2

 This is the default lead format on the cardiograph  This view provides five seconds of continuous ECG

waveform data for each lead on a split screen

 In the split screen display , the limb and augmented leads

on the left, and the precordial leads are on the right

 See Figure 3-9 on page 3-22

PageWriter TC20 Cardiograph Instructions for Use 3-21

Main ECG Screen

Table 3-5 Main Screen Lead Formats (continued)

Lead Format Description

12x1

 This view provides ten seconds of continuous ECG

waveform data for each lead.

 For an example with Cabrera leads, see Figure 4-34 on

page 4-30.

3x4

 This view provides 2.5 seconds of waveform data for

each lead, with 3 total rows with 4 leads in each row

 In this view, the limb and augmented leads are on the

left, and the precordial leads are on the right

 See Figure 3-10 on page 3-22

Figure 3-9 Default 6x2 Lead Format on Main Screen

A Limb Leads B Precordial Leads

Figure 3-10 3x4 Lead Format on Main Screen

3-22 PageWriter TC20 Cardiograph Instructions for Use

Changing the Lead Format on the Main ECG Screen

To change the lead display on the main screen:

Press the down arrow key (on keyboard) or the up arrow key to scroll through the available Main screen lead formats.

2 The lead format that displays on the Main screen when the cardiograph is shut down (by

pressing and holding the On/Standby button ( ) will be retained once the cardiograph is returned to active use.

Taking an Auto ECG

Once all waveforms are of good quality, and all patient information is complete, the ECG button illuminates. When the ECG button illuminates, it means that the ECG is ready to be taken.

To take an Auto ECG:

 When the ECG button is lit, press it to take an Auto ECG.

PageWriter TC20 Cardiograph Instructions for Use 3-23

Using the Preview Screen

The Preview screen displays the ECG exactly as it looks when printed. The ECG button can be touched at any time from the Main screen to display a full-screen preview of an ECG. The ECG captures the most recent 10-seconds of waveform data.

Depending on how the Preview screen is configured to operate, once the ECG appears on the Preview screen it may automatically print, be saved to the Archive, and it may be automatically transferred to TraceMaster or other third party ECG management system. Also, the cardiograph can be configured to automatically retrieve the most recent ECG from the same patient from a specified TraceMaster server for direct comparison purposes at the cardiograph.

To preview an ECG from the Main ECG screen:

On the Main ECG screen, touch the ECG button to see a previewed ECG of the most recent 10-seconds of waveform data. If no patient information has been entered, touch the

ECG button twice rapidly.

NOTE As shown in Figure 3-11, “The Preview Screen,” on page 3-25, the Print, Save, Transfer, or

Last ECG buttons may not appear on your individual cardiograph, or may appear grayed out

(cannot be selected), depending on how your cardiograph is configured. If the buttons are grayed out, your cardiograph is configured to automatically perform these functions. If the buttons do not appear, your cardiograph is not configured to support these functions.

3-24 PageWriter TC20 Cardiograph Instructions for Use

Figure 3-11 The Preview Screen

Changing the Lead Format on the Main ECG Screen

Table 3-6 Preview Screen Description

Preview Screen Item

Feature Name Description

A Layout Button Touch to:

 Change the layout/format of the ECG report displayed on the

screen and change whether the waveforms are displayed simultaneously or time sequentially

 Change the rhythm lead  Change the amount of interpretation that appears on the ECG

report

The new settings are immediately applied.

PageWriter TC20 Cardiograph Instructions for Use 3-25

Using the Preview Screen

Table 3-6 Preview Screen Description (continued)

Preview

Feature Name Description

Screen Item

B Settings Button Touch to:

 Change the optional filter settings (Artifact, Baseline Wander).  Change pacing detection setting.  Change waveform speed and scale settings.  Change the High and Low Pass filter settings.

The new settings are immediately applied.

C Print Button Touch to print the displayed ECG. D Save Button Touch to save the displayed ECG. E Transfer Button Touch to send the displayed ECG to TraceMaster or to a third party

ECG management system.

NOTE Only ECGs with complete required patient information can be

transferred. Touch the ID button to complete any missing required patient information.

F Last ECG Touch to:

 Review on the Preview screen and print from the cardiograph the

most recent previous ECG from the same patient

 Use of this feature requires an active network or modem

connection to the specified TraceMaster server

NOTE The Last ECG feature is only available with the TraceMaster

ECG Management System.

G ECG Report  The displayed ECG report.

 Press the down arrow key ( ) or the up arrow key ( ) to

change the displayed report format. Touch the print out the ECG report with the new format applied.

 Press and hold the Shift key (on keyboard) and then press the

down arrow key ( ) or the up arrow key ( ) to change the level of interpretation displayed on the ECG preview. Touch the

Print button to print out the ECG report with the new

interpretation applied.

H Page forward

Touch to view additional pages of the displayed ECG report and page back button

Print button to

3-26 PageWriter TC20 Cardiograph Instructions for Use

Using the Last ECG Feature on the Preview Screen

Table 3-6 Preview Screen Description

Preview Screen Item

Feature Name Description

(continued)

I Close Button Touch to close the Preview screen and to return to the Main screen J Page Advance

Touch to advance the printer paper to the beginning of the next page

Button

K ID Button Touch to enter missing patient information for the displayed ECG

(not available with the Last ECG feature)

NOTE This feature is not used to enter patient information for a new

patient.

Using the Last ECG Feature on the Preview Screen

When a previous patient ECG is printed at the cardiograph using the Last ECG feature, a note appears on the ECG report specifying that this is a previously recorded ECG.

Figure 3-12 Previous ECG Watermark on ECG Report

PageWriter TC20 Cardiograph Instructions for Use 3-27

Using the Preview Screen

Viewing Event Markers on the Preview Screen

If any Event Markers are captured within the 10-seconds of ECG data that appear on the Preview screen or the printed ECG report, an Event Marker symbol ( ) will appear directly above the waveform. For information on capturing Events on the Main or Rhythm screens, see “Capturing Events from the Main or Rhythm Screens” on page 3-33.

Figure 3-13 Event Marker Symbol on Preview Screen

A Event Marker Symbol on ECG Report

3-28 PageWriter TC20 Cardiograph Instructions for Use

Critical Values on Preview Screen

The algorithm offers a feature called Critical Values, that when enabled will display an ECG message on the Preview screen and print the message on the ECG report in order to notify caregivers of an ongoing or imminent cardiac event, such as a silent MI, that requires immediate treatment. The notification statement displays prominently on the Preview screen. If any of these Critical Values appear on the Preview screen, obtain help immediately.

The messages are triggered by a defined set of interpretive statements that are listed in Appendix B, “Critical Value Statements.” These warning statements include

HIGH HEART RATE

version PH100B, the statement

, COMPLETE HEART BLOCK, and for the Philips DXL ECG Algorithm

ACUTE ISCHEMIA is supported.

The statement VERY HIGH HEART RATE is generated by the following formula: the measured heart rate in beats per minute, minus the patient age in years. If this value is 150 bmp or higher, the

Figure 3-14 Critical Value Message on Preview Screen

VERY HIGH HEART RATE statement will appear on the ECG.

ACUTE MI, VERY

A Complete Heart Block Critical Value Message on Preview Screen

PageWriter TC20 Cardiograph Instructions for Use 3-29

Rhythm ECG Acquisition

Rhythm ECG acquisition is used to print continuous rhythm strips of up to 12 selected leads until the Stop button is touched. The selected Rhythm leads, the size and scale of the waveforms on the printed report, pacing detection settings, and the optional Artifact filter settings may be changed at any time during the recording.

TIP You do not have to stop printing the Rhythm report to change Rhythm leads.

NOTE Rhythm reports are not analyzed.

To record a rhythm ECG:

1 Touch the Rhythm button on the toolbar. 2 Touch the Stop button on the toolbar to stop printing. 3 Touch the Page button on the toolbar to advance the paper to the top of the next page.

To change the rhythm leads:

Touch the Leads button on the toolbar to select a predefined group of leads, or select the leads individually by touching the lead label.

2 Touch the Select All button to select all available rhythm leads. 3 Touch the Apply button to apply the new settings. Touch the Close button to exit the

screen without changing leads. The new rhythm lead settings are immediately applied, and the report continues to print

with the selected rhythm leads.

To change rhythm report settings:

Touch the Settings button on the Status Bar (top of screen). The Settings window appears.

2 Touch the ON/OFF button next to Artifact to enable or to disable the Artifact filter. 3 Touch settings for waveform speed and scale as desired.

NOTE The Chest Leads setting scales the precordial leads to the same size as the limb leads (Full) or

to half the size of the limb leads (Half).

Touch a setting next to Pacing to change the pacing detection setting.

NOTE The Unknown setting is recommended for most ECGs.

Touch the OK button to close the window and to apply the settings. Touch the Cancel button to close the window and to discard the settings.

3-30 PageWriter TC20 Cardiograph Instructions for Use

Special Note about Artifact Filter

DECF

Special Note about Artifact Filter

The purpose of the Artifact filter is to remove skeletal muscle artifact from the ECG signal. Skeletal muscle artifact is the most difficult noise source to eliminate due to the fact that it contains the same frequencies as actual patient ECG signals. The Artifact filter will eliminate skeletal muscle artifact, but it will also reduce all high frequency components of the ECG signal. Due to this fact, use of the Artifact filter may make it impossible to detect pacemaker pulses, and may affect P waves, and the entire QRS-T complex. Only use the Artifact filter for ECGs that otherwise would be unreadable due to significant levels of muscle artifact.

Figure 3-15 The Rhythm Screen with rhythm report printing

Figure 3-16 Rhythm Toolbar with no report actively printing

PageWriter TC20 Cardiograph Instructions for Use 3-31

Rhythm ECG Acquisition

Table 3-7 Rhythm Screen

Rhythm Screen

Feature Name Description

Item

A Settings Button Touch to:

 Change Artifact filter settings  Change pacing setting  Change waveform speed setting  Change waveform scale setting

The new settings are immediately applied.

B Stop Button

 Touch to stop printing the rhythm report .  When the rhythm report is stopped the toolbar shown in

Figure 3-16 on page 3-31 appears.

C Leads Button

 Touch to change the rhythm leads.  This button appears whether or not a rhythm report is

printing.

D Page Button

 Touch to advance the printer paper to the beginning of the

next page.

E Main Screen

Button

F Rhythm Button

 This button only appears when no rhythm report is printing.  Touch to exit the Rhythm screen and return to the Main

screen.

 This button only appears when no rhythm report is printing.  Touch this button to resume printing a rhythm report.

 This button only appears when no rhythm report is printing.

3-32 PageWriter TC20 Cardiograph Instructions for Use

Disclose ECG Acquisition

Disclose ECG acquisition is used to review Events captured on the Main or Rhythm screens, or to review up to 5 minutes of continuous ECG waveform data for a selected lead, in either a static or in a live view. The waveform data may be reviewed on the screen, and any data viewed on the screen may be selected and printed as a standard 12-lead ECG report, or as a 1-minute Disclose report of a single lead. For an example of the 1-minute Disclose report format, see “1-Minute Disclose Report” on page 4-39.

Event Marker Warning

A flashing icon ( ) appears on the Status Bar (top of screen) if Event Markers captured during an individual patient session have not yet been reviewed on the Disclose screen and are about to be deleted. For more information, see “The Status Bar” on page 1-22.

Capturing Events from the Main or Rhythm Screens

If a clinically significant event is viewed on either the Main or Rhythm screens, this clinically significant data can be captured for future review and processing on the Disclose screen. This captured data is called an Event and is marked on the screen with a white arrow symbol ( ). This white arrow symbol is called an Event Marker, and appears directly above the waveform.

Event Marker Warning

The number of Events captured for the current patient session appears as a number (see Figure 3-17) on the

As the waveform data on the screen refreshes, additional Events can be captured as necessary. Even though an Event scrolls off of the screen, it is saved for review on the Disclose screen.

To capture an Event on the Main or Rhythm screens:

If a clinically significant event is viewed, touch and press down on the screen directly above the waveform for two seconds in order to capture the significant data for future review and processing.

2 Once the data is captured, a white Event Marker appears above the waveform. A

maximum of 6 Events can be captured for an individual patient session. After the Event is captured, the number that appears on the

Figure 3-17 Disclose Button with 4 Captured Events

Continue to capture Events as necessary, or proceed to review Events on the Disclose screen. Even though an Event scrolls off of the screen, it is saved for future review and processing. Wait 15 seconds after capturing an Event, and then touch the

Disclose button located on the toolbar.

Disclose button increases by 1.

Disclose button to view Events.

PageWriter TC20 Cardiograph Instructions for Use 3-33

Disclose ECG Acquisition

B C

Reviewing Events on the Disclose Screen

Captured Events can be reviewed on the Disclose screen. When the Disclose button is touched, the Disclose screen appears in a static view.

Figure 3-18 Disclose Screen, Static View with Captured Events

Disclose

Feature Name Description

Screen Item

A Selected Disclose

 Touch to change the displayed Disclose lead.

Lead

 Only one lead may be selected as the Disclose lead.

B Layout Button

 Touch to change ECG report settings, including report layout,

time sequential settings, and any rhythm leads that appear on the 12-lead ECG report

 Touch the change the amount of interpretive information

generated by the algorithm that appears on the ECG report

 The 12-lead ECG report is derived from the 10-seconds of data

that is captured inside the orange Focus box

The new settings are immediately applied.

3-34 PageWriter TC20 Cardiograph Instructions for Use

Philips PageWriter TC20 Instructions For Use Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

About the Instructions for Use

Safety Summary

Symbols Marked on the Cardiograph

Safety Symbols Marked on the Cardiograph Packaging

Safety and Regulatory Symbols Marked on the Cardiograph Cart

Important Patient and Safety Information

Accessories and Supplies

AC Power Adapter and AC Power Cord

Analog ECG Output Signal Port

Batteries

Cart

Defibrillation

Display Accuracy

ECG Interpretation

Electrodes

General Cardiograph Use

IEC 60601-2-51

Main Waveform Display Screen

Pacemaker

Patient Cable

Printer

Servicing the Cardiograph

Software

Touch Screen

USB Memory Stick

The PageWriter TC20 Cardiograph

Intended Use

Indications for Use

The Philips ECG Algorithm

Intended Use

Indications for Use

1Getting Started

PageWriter TC Cardiograph Learning Kit

About the PageWriter TC Cardiograph Learning Kit

Philips ECG XML Information

Using the Philips InCenter Site

About Adobe Acrobat Versions

PageWriter TC20 Cardiograph Components

TC20 Cardiograph

About the Patient Cable

Attaching the Patient Cable to the TC20 Cardiograph

Working with the Battery

Installing the Battery

Charging the Battery

Calibrating the Battery

Battery Power Indicator

Using the Wireless Connection

Using the USB Memory Stick

Using the Barcode Reader

Using the Cardiograph Touch Screen

Touch Screen Overview

Changing the Lead Format on the Main ECG Screen

The Status Bar

Working with Simulated Data

Supplies, Options, and Ordering Information

Ordering Options and Upgrades

Hardware

Software

Accessories

Warranty

Product Troubleshooting

Contacting a Philips Response Center

North America Centers

South America Centers

Europe Centers

Australia and Asia Centers

Africa and Middle East Centers

1Configuring Default Clinical Settings

Configuring the Wireless Option

Password Access

Tips for Creating Secure Passwords

Configuration with a Philips TraceMaster ECG Management System

Configuration with a Third Party ECG Management System

Restoring Custom Configuration Settings

Configuring Multiple Cardiographs

Opening the Setup Screens