Philips M3812A, M3812B Instructions For Use Manual

Notice

Proprietary Information

Published by Philips Medical Systems, a division of Philips Electronics North America Corporation.

Philips Medical Systems reserves the right to make changes to both this Instructions for Use and to the product it describes. Product specifications are subject to change without notice. Nothing contained within this Instructions for Use is intended as any offer, warranty, promise or contractual condition, and must not be taken as such.

© Koninklijke Philips Electronics N.V. 2008 All Rights are reserved. Reproduction in whole or in part in any form or by any means, electrical, mechanical or otherwise, is prohibited without the written consent of the copyright holder.

Document number: M3810-90096

Issue number 5, October 2008 Philips Medical Systems

3000 Minuteman Road Andover, MA 01810-1085 USA

Unauthorized copying of this publication is a copyright infringement and will reduce the ability of Philips Medical Systems to provide accurate and up-to-date information to users. Non-Philips product names may be trademarks of their respective owners.

Published in the United States of America

Notice

Printing History

Personal Health Information Security

New editions of this document will incorporate all material updated since the previous edition. Update packages may be issued between editions and contain replacement and additional pages to be merged by a revision date at the bottom of the page. Note that pages which are rearranged due to changes on a previous page are not considered revised.

The documentation printing date and part number indicate its current edition. The printing date changes when a new edition is printed. (Minor corrections and updates which are incorporated at reprint do not cause the date to change.) The document part number changes when extensive technical changes are incorporated.

All Editions and Updates of this manual and their publication dates are listed below.

First Edition. . . . . . . . . . . . . . . . . . . . . . . . . . . . October 2002

Second Edition . . . . . . . . . . . . . . . . . . . . . . . . . . . . July 2006

Third Edition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .May 2007

Fourth Edition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . May 2008

Fifth Edition . . . . . . . . . . . . . . . . . . . . . . . . . . . October 2008

Telehealth equipment collects personal information in the form of vital sign measurements and survey responses that help your health care organization manage you health care effectively. These data are stored and protected on a secure network and will not be disclosed for purposes other than for the management of your healthcare. Any unintentional disclosure of your personal information will be reported to your health care organization.

Contents/Tabla de contenidos

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

Welcome. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1

How the System Works . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1

Keeping the System Working. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Thank You!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1

Philips Telemonitoring Services System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

Safety and Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Follow Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Document Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Bold Typeface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Display Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

2. Philips Telemonitoring Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1

Device Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2

Home Hub/TeleStation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2

Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5

Standard Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Steady Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Blood Pressure Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7

BP Monitor Display Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Rhythm Strip Recorder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9

Rhythm Strip Recorder Display Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10

Contents/Tabla de contenidos 1

Pulse Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Pulse Oximeter Display Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12

Glucose Meter Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Device Usage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Home Hub/TeleStation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Home Hub . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

TeleStation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Answering Survey Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16

Entering Measurements Manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18

Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21

Measuring Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21

Standard Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21

Steady Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22

Measuring Weight with a Walker. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23

Standard Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23

Steady Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24

Changing Voice Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26

Changing Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27

Changing Weight Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27

Standard Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28

Steady Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29

Blood Pressure Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30

Measuring Blood Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31

Procedure for M3815A Blood Pressure Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31

Procedure for M3815B Blood Pressure Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-35

Rhythm Strip Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38

Measuring Heart Rhythm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38

Pulse Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-40

Measuring Blood Oxygen and Pulse Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-41

Procedure for M3814A Pulse Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-41

Procedure for M3814B Pulse Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-44

Glucose Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-47

Recording Glucose Measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-47

Changing Glucose Meter Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-49

2 Contents/Tabla de contenidos

3. Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Cleaning Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Storing Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Blood Pressure Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Rhythm Strip Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Pulse Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Replacing Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Scale. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Standard Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5

Steady Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7

Blood Pressure Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Rhythm Strip Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Pulse Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

4. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Radio Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Troubleshooting Tables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Home Hub/Telestation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Scale. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8

Standard Scale. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8

Steady Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

Rhythm Strip Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10

Blood Pressure Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Pulse Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13

Contents/Tabla de Contenidos 3

5. Specifications and Regulatory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Intended Use/Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Contra-indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Home Hub . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

TeleStation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Standard Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Steady Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

Blood Pressure Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

Rhythm Strip Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Pulse Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

Physical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

Environmental. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

Electromagnetic Compatibility (except M3813B and M3815B) . . . . . . . . . . . . . . . . . . 5-11

Emissions and Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Avoiding Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Avoiding Static Electrical Discharges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13

Electromagnetic Compatibility (M3813B and M3815B) . . . . . . . . . . . . . . . . . . . . . . . . 5-14

Emissions and Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

Reducing Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

Regulatory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20

FCC Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20

Telephone Regulatory Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21

4 Contents/Tabla de contenidos

Welcome

How the System Works

Introduction

Welcome to Philips Telemonitoring Services. When you use this product, you’ll take a few minutes every day to

measure your weight, vital signs, and/or glucose. These measurements will help you and your healthcare provider make

better decisions about your care. You are providing information that can help improve your quality of life.

With this system, it’s easy to take your measurements from the comfort of your home. The measurements are sent over your phone line to your healthcare provider’s computer

Feel free to talk on your phone at any time -- the system is “smart” enough to know when the phone line is open. It will wait and then send the information after you hang up.

Introduction

Keeping the System Working

If at any time you suspect something is wrong with any of the devices, immediately contact your healthcare provider. Philips will replace any defective device. You can also cross-check your results with another device if additional measurement devices of the same type are available to you.

This Instructions for Use contains easy-to-follow steps for taking your measurements. It also shows you how to maintain the devices so that they will continue to take accurate readings.

Thank You! Thank you for taking an active role in your home healthcare plan. Philips

and your healthcare provider applaud your efforts to actively participate in your health care plan.

Introduction 1-1

Philips Telemonitoring Services System

Patient Telemonitoring Set

Philips Telemonitoring Services System

Your Philips Telemonitoring Services system includes a set of measurement devices known as the Patient Telemonitoring Set. Each device takes an important measurement -- such as weight, blood pressure, pulse rate, heart rhythm, %SpO2 -- and then wirelessly sends that measurement to the Home Hub or TeleStation. A patient’s glucose meter can also send glucose measurements to a TeleStation using a special cable.

Your healthcare provider decides whether you will use one or all of the measurement devices below. The HomeHub/TeleStation is the "communications center." It receives your measurements from the devices and sends them over your phone line to your healthcare provider’s computer. The computer keeps a record of all of your vital sign measurements for review by your healthcare provider.

Scale

SteadyStandard or

Blood Pressure Monitor

Rhythm Strip Recorder

Pulse Oximeter

1-2 Introduction

Home Hub

Radio Telephone

TeleStation

Glucose Meter

Healthcare

Provider

TransmissionTransmission

Safety and Precautions

Follow Instructions

Document Conventions

Warnings Warnings are information you should know to avoid a hazard that

Warning • Do not let anyone else use these devices. They are provided for

Follow your doctor’s instructions about symptoms that require you to contact your healthcare provider. Use of these devices is not intended to replace your existing therapy or drug administration. Remember, only your healthcare provider is trained to interpret the results. He or she will tell you when and how often to take your vital signs. Please read all of the instructions in this guide before using the Philips Telemonitoring System and follow the instructions carefully.

The following conventions will be used in this Instructions for Use to alert you to special or important information in the text.

could result in severe injury or death. Observe the following Warnings with all devices of the Philips

Telemonitoring System.

your use only.

• Do not swap devices with a neighbor or family member who has

the same or similar system.

• These devices are not intended to be used to call for emergency

medical attention or response.

• Do not try to fix a device yourself. If there’s a problem, call your

healthcare provider.

• Do not use a device with the battery door removed.

• Avoid exposing the devices to extremes in temperature, humidity, direct sunlight, shock, dust spill, or standing water.

• Do not let children use the device.

• Throw away packing materials and plastic bags right away. They are a hazard for children.

Introduction 1-3

Safety and Precautions

• Be careful with small parts that can be removed from a device and swallowed, such as the Home Hub’s rubber feet and power adapter clip. They are hazards for children and pets.

• To prevent shock, connect cables only as described in these Instructions for Use.

• Do not connect anything to this system other than Philips Telemonitoring Services devices or glucose meters approved by your healthcare provider.

• To prevent shock, do not use devices during a lightning storm.

• Call your healthcare provider if you are injured using any device.

Cautions Cautions are information you should know to avoid a hazard that could

result in personal injury or property damage. Observe the following Cautions with all devices of the Philips

Telemonitoring System.

Caution • Read these Instructions for Use carefully before using devices.

Notes Notes contain additional information on usage of the Patient

Note

Bold

Typeface

1-4 Introduction

• Use these devices only as directed by your healthcare provider.

• Follow your physician’s instructions regarding symptoms that require direct contact with your healthcare provider.

• Use of these device is not a substitute for medical care.

Telemonitoring System and its devices.

Objects of actions in procedures appear in bold typeface, as shown in the following example:

Step 1. Select the Update button.

Display Symbols

A number of symbols are displayed on various devices or in documentation of the Philips Telemonitoring System. Their meaning and the devices on which they may appear are given in the following table.

Symbol Description Applicable Devices

Type B Patient Applied Parts as defined in IEC 60601-1. Not suitable for direct cardiac application.

Type BF Patient Applied Parts as defined in IEC 60601-1. Not suitable for direct cardiac application.

Attention: Consult accompanying documents.

Meets UL-1950, CSA-950, IEC-60950 standards

Meets CSA IEC-60950-1 standards

In TelePort serial data port for connection to Philips devices only

Scale (M3813A, M3813B) Blood Pressure Monitor Rhythm Strip Recorder Pulse Oximeter (M3814A)

Pulse Oximeter (M3814B)

Home Hub/TeleStation Scale (M3813A, M3813B) Blood Pressure Monitor Rhythm Strip Recorder Pulse Oximeter

Home Hub/TeleStation TeleStation Scale (M3813A) Blood Pressure Monitor Rhythm Strip Recorder Pulse Oximeter

TeleStation

AC Power adapter connection (9.0VAC/500mA Use Philips-supplied adapter only)

TeleStation

Introduction 1-5

Display Symbols

Symbol Description Applicable Devices

Telephone or telephone line TeleStation

Meets standards CSA 60601-1, UL 60601-1

Scale (M3813B)

Meets Class B standards.

Meets Part 15 standards.

Home Hub/TeleStation Standard Scale Steady Scale Blood Pressure Monitor Rhythm Strip Recorder Pulse Oximeter

Standard Scale Steady Scale Blood Pressure Monitor Rhythm Strip Recorder

Pulse Oximeter

Meets Part 68 standards Home Hub/TeleStation

1-6 Introduction

Overview

Philips Telemonitoring Set

Chapter 2 provides a detailed description of the devices of the Philips Telemonitoring Set and how to use them. It includes the following.

Page

Device Descriptions. . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Home Hub/TeleStation . . . . . . . . . . . . . . . . . . . . . 2-2

Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Blood Pressure Monitor. . . . . . . . . . . . . . . . . . . . . 2-7

Rhythm Strip Recorder . . . . . . . . . . . . . . . . . . . . . 2-9

Pulse Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Glucose Meter Cable. . . . . . . . . . . . . . . . . . . . . . 2-14

Device Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Home Hub/TeleStation . . . . . . . . . . . . . . . . . . . . 2-15

Home Hub . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

TeleStation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Answering Survey Questions . . . . . . . . . . . . . . . . . . 2-16

Entering Measurements Manually . . . . . . . . . . . . . . 2-18

Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21

Measuring Weight . . . . . . . . . . . . . . . . . . . . . . . . . 2-21

Measuring Weight with a Walker. . . . . . . . . . . . . . 2-23

Changing Voice Volume . . . . . . . . . . . . . . . . . . . . 2-26

Changing Language . . . . . . . . . . . . . . . . . . . . . . . 2-27

Changing Weight Units . . . . . . . . . . . . . . . . . . . . . 2-28

Blood Pressure Monitor. . . . . . . . . . . . . . . . . . . . 2-30

Measuring Blood Pressure . . . . . . . . . . . . . . 2-31

Rhythm Strip Recorder . . . . . . . . . . . . . . . . . . . . 2-38

Measuring Heart Rhythm . . . . . . . . . . . . . . . . . 2-38

Pulse Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . 2-40

Measuring Blood Oxygen and Pulse Rate . . . . . . 2-41

Glucose Meter . . . . . . . . . . . . . . . . . . . . . . . . . . 2-47

Recording Glucose Measurements. . . . . . . . . . . . 2-47

Changing Glucose Meter Time and Date . . . . . . . 2-49

Introduction

Philips Telemonitoring Set 2-1

Device Descriptions

The Philips Telemonitoring Set consists of a Home Hub or

TeleStation, which serves as the "communications center" of the system, and devices that measure important healthcare vital signs -- Scale (weight), Blood Pressure Monitor (blood pressure), Rhythm Strip Recorder (heart rhythm), Pulse Oximeter (%SpO2, pulse rate), Glucose Meter (glucose level).

Note: The PTS system provides only a cable for connecting the

patient’s glucose meter to the system.

This section provides a brief description of each of these devices. More detailed descriptions of how to use each device to make its measurement are given in the sections that follow.

Home Hub/

TeleStation

Home Hub

You will have either a Home Hub or a TeleStation, depending on the home healthcare plan designed for you.

After you take a measurement, such as weight, the Home Hub/ TeleStation receives the result. It then sends the result to your healthcare provider’s computer when both telephone lines (yours and the computer’s) are free.

If you pick up your telephone while the Home Hub/TeleStation is dialing or sending the result, you will not hear a dial tone. Hang up the phone and wait for 5 seconds. Then make your call. The Home Hub/ TeleStation will send the result when the phone line is open. Your healthcare provider will call you if your results are not received.

TeleStation (M3812B)

Home Hub (M3812A)

on data

on data using

using phone

phone

on/survey

waiting

TeleStation

on/survey

holding

using

waiting

results

phone

holding results

go back

using phone

2-2 Philips Telemonitoring Set

Device Descriptions

Indicators The Home Hub and TeleStation have lights on the front that indicate

what it is currently doing. The on or on/survey waiting light stays lit as long as the Home Hub/

TeleStation is plugged in. If you have the TeleStation and the on/survey waiting light is

flashing, you have questions to answer. Your healthcare provider may activate the TeleStation to beep every 60 seconds to alert you that a survey is waiting.

The data or holding results light comes on when the Home Hub or TeleStation receives your measurement results and stays on until those results have been sent over the telephone.

The using phone light comes on when the Home Hub or TeleStation is sending your results to your healthcare provider’s computer.

Warnings The following Warnings apply to the use of Home Hub/TeleStations.

Warning • Use only the Philips-supplied power adapter for the Home Hub/

TeleStation.

– Do not place anything on top of the adapter. – Plug the adapter into an outlet near the Home/Hub Telestation

for easy access.

– Unplug the adapter from the outlet to disconnect.

• Do not place the Home Hub/TeleStation where anyone, especially

children, can step on, trip over or get tangled in phone or power adapter cords.

• Do not place the Home Hub/TeleStation near running water or

where liquids (for example, a cup of coffee or water in a vase of flowers) might spill onto it.

• Unplug power and phone cords before cleaning the Home Hub/

TeleStation.and prior to an impending lightning storm

• Do not put lighted tobacco products or candles on Home Hub/

TeleStations.

• Do not overload circuits where Home Hub/TeleStation are

installed.

Philips Telemonitoring Set 2-3

Device Descriptions

• If you have a personal response service (except for LifeLine

Systems), it must be installed on its own phone line (not just a separate telephone jack). If you have a LifeLine



System telephone, ensure that the Home

Hub/Telestation is plugged into the phone jack labeled AUX on the back of the LifeLine unit.

• Do not touch, use, clean, or handle the Home Hub/TeleStation or

your connected glucose meter during a thunderstorm.

Cautions The following Cautions apply to using the HomeHub or TeleStation.

Caution • Avoid placing the Home Hub/TeleStation on a metal surface or

inside a metal enclosure as it can interfere with the radio signal.

• Do not use electronic devices, such as cordless and cellular phones

and computers, near the Home Hub/TeleStation

• Avoid placing large appliances or metal furniture near the Home Hub/TeleStation as they can block radio signals from the measurement devices.

• High temperatures can affect the LCD screen of your TeleStation.

– Choose a location away from direct sunlight. – Operate the TeleStation at room temperature.

• Make sure that the Home Hub/TeleStation is plugged into its telephone jack and electrical outlet at all times, except when cleaning or prior to an impending lightning storm.

• Make sure that a light switch or power strip does not turn off power to the Home Hub/TeleStation.

• Clear voice mail messages. Telephone services that modify the dial tone, such as voice mail, can interfere with transmissions made by the Home Hub/TeleStation.

• If you are using a glucose meter connected to your TeleStation:

– Follow the glucose meter manufacturer’s instructions. – Follow any additional instructions from your healthcare provider. – Do not take glucose measurements while your glucose meter is

connected to your TeleStation.

2-4 Philips Telemonitoring Set

Device Descriptions

Scale You may have either a Standard Scale or a Steady Scale. Both scales

speak your weight.

Standard

Scale

The Standard Scale is for people who can get on and off the Scale without help. It has a maximum weight limit of 440 lbs (200 kgs).

Display

Platform

The scale announces your weight (in English or Spanish). The front panel has a Volume control button and a Radio Test

button . Batteries are stored underneath the platform.

Steady Scale The Steady Scale has a column with grab bars to help people keep their

balance when using the Scale. It has a maximum weight limit of 365 lbs (166 kgs).

Display

Grab Bars

Column

Platform

Philips Telemonitoring Set 2-5

Device Descriptions

The Steady Scale announces your weight in English only. The front panel has a Volume control and a Radio Test button . Batteries are stored underneath the display case.

Warnings The following Warnings apply to use of the Scale.

Warning • Do not use the Scale in standing water.

• Do not store the Scale where children or pets could get hurt by playing with the grab bars and knocking the Scale over.

Cautions The following Cautions apply to use of the Scale.

Caution • Do not use the Standard Scale if you weigh over 440 pounds

(200 kilograms).

• Do not use the Steady Scale if you weigh over 365 pounds (166 kilograms).

• Keep the Scale in a dry, temperature controlled place, not in the bathroom.

• Position the Scale away from metal objects, such as a refrigerator, as they can block transmission to your Home Hub/TeleStation.

• Place the Scale on the floor between 1 to 3 inches (2.5 to 7.5 cm) from a wall and facing it.

• Only one person should use the Scale.

• Do not use the Scale to measure anything other than yourself, such as a package or pet, because all measurements are sent to your healthcare provider.

• Do not drop or drag the Scale.

• Do not step on the Scale’s corners.

• The scale should be used on a flat, hard surface if at all possible.

• If the scale is used on carpet, carpet feet may have to be installed.

• Traveling with the Scale is not recommended.

Note If you don’t feel comfortable taking your weight using the Standard

Scale, contact your healthcare provider.

2-6 Philips Telemonitoring Set

Device Descriptions

Blood Pressure Monitor

Note Two models of BP Monitor are available (M3815A and M3815B ) and

BP Monitor

Display Case

RADIO TEST

button

You may have a Blood Pressure Monitor if your home healthcare plan includes measuring your blood pressure and pulse.

The Blood Pressure Monitor (also called a BP Monitor) is a plastic display case with a removable blood pressure cuff. The BP Monitor displays your blood pressure and pulse.

The BP Monitor has an air hose connector on the left side. The blood pressure cuff has a metal D-ring (a metal bar that the cuff slides through and loops over), an air hose, and an air connector. Batteries are stored underneath the display case.

are shown below. Check your BP Monitor to determine which one you have. The part numbers are shown on the rear of the monitor.

Both monitors have a display window that shows the systolic and diastolic blood pressure and pulse rate, a START/STOP button and a

RADIO TEST button -- . (on M3815A) or (on M3815B).

BP Display Window

M3815A

START/

STOP

M3815B

button

RADIO TEST

button

START/

STOP

button

Air Hose

Cuff

Philips Telemonitoring Set 2-7

Device Descriptions

Warnings The following Warnings apply to use of the BP Monitor.

Warning • Avoid storing the BP Monitor where children or pets can get at it.

There is a risk of injury if they get tangled in the air hose or if the cuff inflates.

Cautions The following Cautions apply to use of the BP Monitor.

Caution • If you get an error message when taking your blood pressure or

think the reading may be wrong, take it again.

• Do not store the BP Monitor inside a metal drawer or container, such as a file cabinet. It will interfere with the radio signal to the Home Hub/TeleStation.

• Do not store the BP Monitor with the cuff assembly twisted or folded tightly.

• Avoid tugging at the air hose or using it to carry the BP Monitor.

• Watch the display when taking your blood pressure.

– If the numbers go up to 330 mmHg,

press the START/STOP button immediately.

– If the numbers drop down to 15 mmHg and stay that way for

more than 3 minutes, press the START/STOP button again.

– If either of these conditions occur, contact your healthcare

2-8 Philips Telemonitoring Set

provider.

Device Descriptions

Rhythm Strip Recorder

Rhythm Strip

Recorder

Display Case

You may have a Rhythm Strip Recorder if your healthcare plan includes recording your heart rhythm.

The Rhythm Strip Recorder is a plastic display case with an attached dual cable with snap-on connectors. Each of the two metal wristbands has a black plastic pad. One side of the pad has a metal snap and the other side has a flat piece of metal. Batteries are stored underneath the display case

The display case has a START button, a RELAX light, and a RADIO

TEST button .

Relax Light

Rhythm Strip Recorder Display Unit

START Button

RADIO TEST Button

Dual Cable

Wristbands

Snap-on Connectors

Philips Telemonitoring Set 2-9

Device Descriptions

Warnings The following Warnings apply to use of the Rhythm Strip Recorder.

Warning • Do not store the Recorder where children or pets can get tangled in

the cables and the wristband.

• The wristbands may cause skin irritation, injury or an allergic reaction to metal.

– Stop using the recorder if you have redness, rash, or other skin

problems.

– Contact your healthcare provider.

Cautions The following Cautions apply to use of the Rhythm Strip Recorder.

Caution • Do not store the Recorder inside a metal drawer or container, such

as a file cabinet. It will interfere with the radio signal to the Home Hub/TeleStation.

• Store the Recorder so that the dual cable is not twisted or kinked.

• Avoid tugging at the dual cable or carrying the Recorder by the cable.

2-10 Philips Telemonitoring Set

Device Descriptions

Pulse Oximeter

The Pulse Oximeter measures blood oxygen level (%SpO2) and pulse rate. It has a plastic display case with a finger-clip sensor attached to it. The front of the case is shown in the figure below. The rear of the case has a compartment for batteries that power the device.

Note Two models of Pulse Oximeter are available (M3814A and M3814B).

Check your Pulse Oximeter to determine which one you have. The part numbers are shown on the rear of the device.

Pulse

Oximeter

Display Case

LED display windows show the blood oxygen level (%SpO2) and pulse rate (in beats per minute) measured from the end of your finger.

The M3814A has 1 display in which %SpO2 and pulse (/min.) measurements alternate. LEDs below the display light to indicate which measurement is being displayed.

The M3814B has 2 displays, one each for %SpO2 and pulse (/min.). Pushing the START button causes the Pulse Oximeter to begin taking a

measurement. The Radio Test button . on M3814A, on M3814B -- tests

the transmission of measurements from the Pulse Oximeter to the Home Hub or TeleStation.

The Finger-clip sensor is clipped on the end of one of your fingers and measures your blood oxygen level and pulse rate.

M3814A M3814B

One Display

START button

Radio Test button

Finger-clip Sensor

Two Displays

Radio Test button

Philips Telemonitoring Set 2-11

START STOP button

Device Descriptions

Warnings The following Warnings apply to use of the Pulse Oximeter.

Warning • Do not use a damaged sensor.

• Do not let children use the device.

• Do not apply the finger sensor to a finger on the same arm where a Blood Pressure cuff is present or has recently been used.

• Avoid excessive motion during measurements, this can lead to inaccurate measurements.

• Make sure the finger is not deeply pigmented with dark nail polish, artificial nails, dye, or pigmented cream. This could cause inaccurate measurements.

• Cover the sensor with opaque material under conditions of strong or excessive light (infrared lamps, photo therapy, etc.) Failure to do so can result in inaccurate measurements.

• Avoid exposing the devices to extremes in temperature, humidity, direct sunlight, shock, dust, spills, or standing water.

• The finger sensor can be comfortably clipped onto the finger (not thumb) of patients weighing > 90 lb. If the sensor is too tight, it may result in inaccurate measurements.

• The sensor may cause skin irritation, injury or an allergic reaction.

– Stop using the Pulse Oximeter if you have redness, rash, skin tear,

or other skin problems.

– Contact your healthcare provider.

• Do not use the device with the battery door removed.

• To prevent shock, do not use devices during a lightning storm.

2-12 Philips Telemonitoring Set

Device Descriptions

Cautions The following Cautions apply to use of the Pulse Oximeter.

Caution • Read the procedures carefully before using this device.

• Use this device only as directed by your healthcare provider.

• Follow your physician’s instructions regarding symptoms that

require direct contact with your healthcare provider.

• This device is not intended for continuous monitoring. The

recommended maximum time for the sensor to be attached to a finger is no more than 4 minutes (more than enough time for a measurement to be obtained). Do not leave the finger sensor on the patients finger between measurements.

• This device may not work properly on all people. If you are unable

to achieve stable readings within 3 or 4 attempts, discontinue use and contact your healthcare provider.

• Use of this device is not a substitute for medical care.

• If you have any questions regarding how to use your Pulse

Oximeter, contact your healthcare provider.

• Abnormal hemoglobin may affect accuracy.

Philips Telemonitoring Set 2-13

Device Descriptions

Glucose Meter Cable

The Patient Telemonitoring Set may also provide a Glucose Meter Cable for connecting your Glucose Meter to a TeleStation to record your

glucose measurements. The Cable for the Bayer Ascensia Contour 7151B glucose meter is different from the Cable for the OneTouch Basic and OneTouch Profile glucose meters..

TeleStation

Bayer Ascensia Glucose Meter

One Touch Ultra & Profile Glucose Meters

Glucose Meter Cables

Warnings The following Warnings apply to the use of a Glucose Meter Cable.

Warning Glucose Meter readings can only be recorded on a TeleStation. They

cannot be recorded on a Home Hub. The PTS System operates only with the Bayer Ascensia Contour 7151B,

OneTouch Basic and OneTouch Profile glucose meters. The Bayer Ascensia Contour 7151B operates only with TeleStations with serial numbers SN: US4837 and higher. The serial number is on the label on the back of the TeleStation under the Philips logo. No other glucose meters should be connected to a TeleStation.

Do not measure your glucose while your Glucose Meter is connected to the TeleStation.

Clean your finger of blood before using the TeleStation.

Note For procedures on how to measure your glucose with your Glucose Meter

refer to its Instructions for Use manual.

2-14 Philips Telemonitoring Set

Device Usage

This section describes how to use each of the devices of the Philips Telemonitoring Set -- HomeHub/TeleStation, Scale, Blood Pressure Monitor, Rhythm Strip Recorder, Pulse Oximeter, and the cable for your Glucose Meter.

Home Hub/ TeleStation

The Home Hub or TeleStation is the communications center for your Patient Telemonitoring Set. You may have either a Home Hub or a TeleStation depending on your healthcare plan.

Once the Home Hub/TeleStation is hooked up to your telephone and plugged into the wall, it will send your measurements to your provider when your phone line is free.

Note The Home Hub and TeleStation depend on your phone number to

transmit results. They cannot be used with phones that have another number.

Home Hub The Home Hub receives your measurement results from your

measurement devices by radio signals and automatically sends them to your healthcare provider’s computer. No actions are required by you after you have made your measurement.

TeleStation TeleStations also have the additional capability of asking you questions

about your health and sending your answers to your healthcare provider. Some TeleStations also have the ability to let you enter your measurements manually and to receive results from some Glucose Meters. Procedures for using these TeleStation features are given in the following sections

Philips Telemonitoring Set 2-15

Device Usage

Answering Survey Questions

The front panel of the TeleStation has a number of buttons to assist you in answering questions and lights to indicate when questions have been sent, as shown in the following figure.

Hello! Welcome to Philips Automated Interactions. To adjust the contrast push the Go Back button. Push Continue to go to the questions.

on/survey waiting light

Continue

TeleStation

holding results

using phone

on/survey waiting

holding results light

go back

using phone light

go back

button

The on/survey waiting light flashes on the front of your TeleStation when there are questions from your healthcare provider waiting to be answered.

Your healthcare provider may activate the TeleStation to beep every 60 seconds to alert you that a survey is waiting.

To answer survey questions, use the following procedure

Step 1. Questions show on the screen with answer choices:

– Push the button next to the best answer. – Choose only one. The answer will be highlighted.

If you make a mistake:

– Select the go back button and choose your answer again.

Step 2. After you select an answer, the next question is displayed.

– Answer it by pushing a button. – Answer all of the questions.

2-16 Philips Telemonitoring Set

+ 82 hidden pages

Philips M3812A, M3812B Instructions For Use Manual

Specifications and Main Features

Frequently Asked Questions

User Manual