Philips Medical Systems North America M3814B M3814B HOME PULSE OXIMETER User Manual USERS MANUAL

Download:
Mirror Download [FCC.gov]
Document ID	1036537
Application ID	HbSTsfkdf0CriWTPh1CbeQ==
Document Description	USERS MANUAL
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	223.03kB (2787914 bits)
Date Submitted	2008-11-26 00:00:00
Date Available	2008-11-26 00:00:00
Creation Date	0000-00-00 00:00:00
Producing Software	Amyuni PDF Converter
Document Lastmod	2008-11-20 14:42:10
Document Title	USERS MANUAL

2
Notice
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
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
Personal
Health
Information
Security
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Standard Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Steady Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Measuring Weight with a Walker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Standard Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Steady Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Changing Voice Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Changing Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2-21
2-21
2-22
2-23
2-23
2-24
2-26
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood Pressure Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rhythm Strip Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pulse Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3-3
3-3
3-3
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
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.
How the
System
Works
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.
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
Introduction
Introduction
Philips Telemonitoring Services System
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.
Patient Telemonitoring Set
Scale
Standard or
Steady
Blood Pressure Monitor
Healthcare
Provider
Home Hub
Rhythm Strip Recorder
Radio
Transmission
or
TeleStation
Pulse Oximeter
Glucose Meter
1-2
Introduction
Telephone
Transmission
Safety and Precautions
Safety and Precautions
Follow
Instructions
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.
Document
Conventions
The following conventions will be used in this Instructions for Use to
alert you to special or important information in the text.
Warnings
Warnings are information you should know to avoid a hazard that
could result in severe injury or death.
Observe the following Warnings with all devices of the Philips
Telemonitoring System.
Warning
•
Do not let anyone else use these devices. They are provided for
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
Cautions
•
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 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
Notes
•
Read these Instructions for Use carefully before using devices.
•
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.
Notes contain additional information on usage of the Patient
Telemonitoring System and its devices.
Note
Bold
Typeface
Objects of actions in procedures appear in bold typeface, as shown in the
following example:
Step 1. Select the Update button.
1-4
Introduction
Display Symbols
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.
Scale (M3813A, M3813B)
Blood Pressure Monitor
Rhythm Strip Recorder
Pulse Oximeter (M3814A)
Type BF Patient Applied Parts as defined in
IEC 60601-1.
Not suitable for direct cardiac application.
Attention: Consult accompanying documents.
Pulse Oximeter (M3814B)
Home Hub/TeleStation
Scale (M3813A, M3813B)
Blood Pressure Monitor
Rhythm Strip Recorder
Pulse Oximeter
Meets UL-1950, CSA-950, IEC-60950 standards Home Hub/TeleStation
Meets CSA IEC-60950-1 standards
In TelePort serial data port for connection to
Philips devices only
TeleStation
Scale (M3813A)
Blood Pressure Monitor
Rhythm Strip Recorder
Pulse Oximeter
TeleStation
AC Power adapter connection (9.0VAC/500mA TeleStation
Use Philips-supplied adapter only)
Introduction
1-5
Display Symbols
Symbol
Description
Applicable Devices
Telephone or telephone line
TeleStation
Meets standards CSA 60601-1, UL 60601-1
Scale (M3813B)
US
Meets Class B standards.
Home Hub/TeleStation
Standard Scale
Steady Scale
Blood Pressure Monitor
Rhythm Strip Recorder
Pulse Oximeter
Meets Part 15 standards.
Standard Scale
Steady Scale
Blood Pressure Monitor
Rhythm Strip Recorder
Pulse Oximeter
Meets Part 68 standards
1-6
Introduction
Home Hub/TeleStation
Overview
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 . . . . . . . . . . . . . . . . . . . . . . . . .
Measuring Weight with a Walker . . . . . . . . . . . . . .
Changing Voice Volume . . . . . . . . . . . . . . . . . . . .
Changing Language . . . . . . . . . . . . . . . . . . . . . . .
Changing Weight Units . . . . . . . . . . . . . . . . . . . . .
2-21
2-23
2-26
2-27
2-28
Blood Pressure Monitor . . . . . . . . . . . . . . . . . . . .
Measuring Blood Pressure . . . . . . . . . . . . . .
Rhythm Strip Recorder . . . . . . . . . . . . . . . . . . . .
Measuring Heart Rhythm . . . . . . . . . . . . . . . . .
Pulse Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . .
2-30
2-31
2-38
2-38
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
Philips Telemonitoring Set
2-1
Introduction
Philips Telemonitoring Set
Device Descriptions
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
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)
Home Hub
on
data
using
phone
TeleStation
go back
on/survey holding
waiting results
on
2-2
Philips Telemonitoring Set
data
using
phone
using
phone
on/survey holding
waiting results
using
phone
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
Warning
The following Warnings apply to the use of Home Hub/TeleStations.
•
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
•
•
Cautions
Caution
The following Cautions apply to using the HomeHub or TeleStation.
•
•
•
•
•
•
•
•
2-4
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.
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.
Philips Telemonitoring Set
Device Descriptions
Scale
Standard
Scale
You may have either a Standard Scale or a Steady Scale. Both scales
speak your weight.
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
Warning
Cautions
Caution
•
•
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.
The following Cautions apply to use of the Scale.
•
•
•
•
•
•
•
•
•
•
•
2-6
The following Warnings apply to use of the Scale.
•
Note
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.
If you don’t feel comfortable taking your weight using the Standard
Scale, contact your healthcare provider.
Philips Telemonitoring Set
Device Descriptions
Blood
Pressure
Monitor
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.
Note
Two models of BP Monitor are available (M3815A and M3815B) and
are shown below. Check your BP Monitor to determine which one you
have. The part numbers are shown on the rear of the monitor.
BP Monitor
Display Case
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).
RADIO
TEST
button
BP Display Window
M3815B
M3815A
RADIO
TEST
button
START/
STOP
button
START/
STOP
button
Air Hose
Cuff
Philips Telemonitoring Set
2-7
Device Descriptions
Warnings
Warning
Cautions
Caution
The following Warnings apply to use of the BP Monitor.
•
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.
The following Cautions apply to use of the BP Monitor.
•
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
provider.
2-8
Philips Telemonitoring Set
Device Descriptions
Rhythm
Strip
Recorder
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
Rhythm Strip
Recorder
Display Case
The display case has a START button, a RELAX light, and a RADIO
TEST button
Rhythm Strip Recorder Display Unit
Relax
Light
START
Button
RADIO
TEST
Button
Dual Cable
Wristbands
Snap-on
Connectors
Philips Telemonitoring Set
2-9
Device Descriptions
Warnings
Warning
The following Warnings apply to use of the Rhythm Strip Recorder.
•
•
Cautions
Caution
2-10
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.
The following Cautions apply to use of the Rhythm Strip Recorder.
•
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.
Philips Telemonitoring Set
Device Descriptions
Pulse
Oximeter
The Pulse Oximeter measures blood oxygen level (%SpO 2) 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 (%SpO 2) 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 %SpO 2 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
Two
Displays
START
button
Radio Test
button
Finger-clip
Sensor
Radio Test START
button
STOP
button
Philips Telemonitoring Set
2-11
Device Descriptions
Warnings
Warning
2-12
The following Warnings apply to use of the Pulse Oximeter.
•
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.
Philips Telemonitoring Set
Device Descriptions
Cautions
Caution
The following Cautions apply to use of the Pulse Oximeter.
•
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
Warnings
Warning
Glucose
Meter
Cables
The following Warnings apply to the use of a Glucose Meter Cable.
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
2-14
For procedures on how to measure your glucose with your Glucose Meter
refer to its Instructions for Use manual.
Philips Telemonitoring Set
Device Usage
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
TeleStation
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.
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.
Continue
TeleStation
on/survey
waiting
on/survey
waiting light
holding
results
using
phone
holding
results light
go back
go back
button
using
phone light
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
Device Usage
Step 3. If you want to change your answer to an earlier question:
– Push the go back button until you see that question again.
– Then push the button next to the correct answer.
Note
If you go back to change an answer to an earlier question, you will then
need to answer all of the questions that follow again. The last question
will confirm that your responses are complete.
Step 4. When you have finished the survey, the holding results light
will come on followed in a few minutes by the using phone light.
This indicates that your results are being sent to your healthcare
provider’s computer.
Philips Telemonitoring Set
2-17
Device Usage
Entering Measurements Manually
For TeleStations that permit manual entry of your measurements, the
procedure is as follows.
Note
Your TeleStation may not have this feature. Consult your healthcare
provider if you want to use this feature.
Step 1. Take your measurements as directed by your healthcare provider
and write down the results.
Step 2. Press any button – except go back.
A menu screen appears showing the measurements that can be entered.
Please select a
measurement to enter
Weight
Blood Pressure
Blood Sugar
Temperature
Oxygen Level
More
TeleStation
on/survey
waiting
holding
results
using
phone
go back
do not
press
go back
Step 3. Press the button next to the measurement you want to enter,
or
press the More button to see other measurements.
2-18
Philips Telemonitoring Set
Device Usage
The measurement entry screen appears, for example WEIGHT as shown
below.
Pleaseenter
Please
enteryour
your
WEIGHT
WEIGHT
WT
WT 167.3
167.
33LBSLBS
More
More
Less
AllFinished
Finished
Next Number All
TeleStation
on/survey
on/survey
waiting
waiting
Note
holding
holding
results
results
using
using
phone
phone
go back
go
back
If you make a mistake, press the go back button before you press the All
Finished button.
Step 4. Use the More and Less button to set the number on the screen to
match the measurement you wrote down earlier.
Note
To make big changes to a number, press the Next Number button one or
more times, then use the More or Less buttons.
When entering Blood Pressure and Oxygen Level measurements, press
Continue to move to the next part of the entry.
When you have finished entering your measurement:
Step 5. Press the All Finished button to store your measurement.
Step 6. Repeat Steps 3-5 to enter any other measurements.
Philips Telemonitoring Set
2-19
Device Usage
Several minutes after you store your last measurement, the screen will go
blank and the using phone light will turn on indicating that your
measurements are being sent to your healthcare provider’s computer.
Note
If you get an invalid reading on your measurement device, do not enter it
in the TeleStation.
If you accidently turn on the measurement screen, do not press any
buttons. After a few minutes the screen will go blank.
2-20
Philips Telemonitoring Set
Device Usage
Scale
Two types of scale are available:
Standard Scale for people who can get on and off without help
Steady Scale with a column and grab bar to help keep your balance.
Notes
If you have been given a Standard Scale and are having balance problems
standing on it, contact your healthcare provider. A Standard Scale can be
converted to a Steady Scale.
If you need the support of a walker, refer to the following section
Measuring Weight with a Walker.
Measuring
Weight
Procedures for measuring your weight on both the Standard and Steady
Scales are as follows. Choose the procedure for your type of Scale.
Standard Scale
Step 1. Step on the Scale and stand on it without holding onto anything.
– Stand as much in the center of the platform as possible.
– Try not to step on the corners; you might damage the Scale.
Step 2. The Scale will say, “Please stand still”. Do not move.
Walking "-" will show on the display during the measurement.
Notes
You will not hear the voice prompt if the volume is set to 0.
After several seconds, the Scale will say “Please step off the Scale”.
Step 3. Step off the Scale.
About 5 seconds after you step off the Scale, the Scale will say your final
weight (unless the volume is set to 0).
The Scale then turns off by itself.
Notes
If the batteries in the Scale are weak, the Scale’s display will alternately
flash Lo and batt and announce "Please replace the scale batteries" for
3 measurements and then the voice turns off.
If this message appears on the display or the voice is silent even though it
is not set to 0, change the Scale’s batteries following the Replacing
Batteries procedure on page 3-4.
Philips Telemonitoring Set
2-21
Device Usage
Steady Scale
Step 1. Step on the Scale and stand on it holding the
grab bars as shown opposite. You can continue
holding the grab bars while taking your weight.
– Stand as much in the center of the platform
as possible.
– Try not to step on the corners; you might
damage the Scale.
Step 2. The Scale will say, “Please stand still”,
and the Stand Still light will come on.
Do not move.
Changing weight values will show on the
display.
The final weight displayed is the correct weight.
Notes
You will not hear the voice prompt if the volume is set to 0.
After several seconds, the Scale will say “Please step off the Scale”,
(unless the volume is set to 0) and the Step Off light will come on.
Step 3. Step off the Scale.
About 5 seconds after you step off the Scale, the Scale will say (unless
the volume is set to 0) and display your final weight.
The Scale then turns off by itself.
Notes
If the batteries in the Scale are weak, the Scale’s Stand Still light will
flash instead of remaining on.
If this message appears on the display or the voice is silent even though it
is not set to 0, change the Scale’s batteries following the Replacing
Batteries procedure on page 3-4.
2-22
Philips Telemonitoring Set
Device Usage
Measuring
Weight with a
Walker
If it is necessary to use a walker to steady yourself on the Scale, use the
following procedure for either the Standard Scale or Steady Scale.
Note
You must remove your hands from your walker for the Scale to take your
true weight.
Standard Scale
Step 1. Place the walker so its legs are on either
side of the Scale platform as shown opposite.
Step 1. Step on the Scale and use the walker arms for
balance.
– Stand as much in the center of the platform as
possible.
– Try not to step on the corners; you might
damage the Scale.
Step 2. Remove your hands from the walker arms.
Step 3. The Scale will say, “Please stand still”. Do not move.
Walking "-" will show on the display during the measurement.
Notes
You will not hear the voice prompt if the volume is set to 0.
After several seconds, the Scale will say “Please step off the Scale”.
Step 4. Grasp the walker arms.
Step 5. Step off the Scale.
About 5 seconds after you step off the Scale, the Scale will say your final
weight (unless the volume is set to 0).
The Scale then turns off by itself.
Notes
If the batteries in the Scale are weak, the Scale’s display will flash Lo
and batt alternately instead of Walking "-".
If this message appears on the display or the voice is silent even though it
is not set to 0, change the Scale’s batteries following the Replacing
Batteries procedure on page 3-4.
Philips Telemonitoring Set
2-23
Device Usage
Steady Scale
Step 1. Place the walker so its legs are on either
side of the Scale platform as shown opposite.
Step 2. Step on the Scale and stand using the walker arms for balance.
– Stand as much in the center of the
platform as possible.
– Try not to step on the corners; you might
damage the Scale.
Step 3. Move your hands from the walker arms
to the Scale’s grab bars. You can continue
to use the Scale’s grab bars for balance
while you are taking your weight.
Note
You must remove your hands from your walker for the Scale to take your
true weight.
Step 4. The Scale will say, “Please stand still” and the Stand Still light
will come on.
Do not move.
Changing weight values will show on the display. The final weight
displayed is the correct weight.
Notes
You will not hear the voice prompt if the volume is set to 0.
After several seconds, the Scale will say “Please step off the Scale”,
(unless the volume is set to 0) and the Step Off light will come on.
Step 5. Move your hands from Scale’s grab bars to the walker arms.
Step 6. Step off the Scale.
About 5 seconds after you step off the Scale, the Scale will say (unless
the volume is set to 0) and display your final weight.
The Scale then turns off by itself.
2-24
Philips Telemonitoring Set
Device Usage
Notes
If the batteries in the Scale are weak, the Scale’s Stand Still light will
flash instead of remaining on and the voice prompt is quiet even though
the volume is not set to 0.
If this message appears on the display or the voice is silent even though it
is not set to 0, change the Scale’s batteries following the Replacing
Batteries procedure on page 3-4.
Philips Telemonitoring Set
2-25
Device Usage
Changing
Voice Volume
The Scale’s voice has 4 volume settings, as follows:
Note
The procedure for changing the volume is identical for both scales.
The only difference is the label on the Volume button.
Setting
Volume
Silent
Low
Medium
High
The volume of the Scale’s voice can be changed as follows:
The Standard Scale has a speaker symbol
The Steady Scale has the word Volume.
Step 1. Step off the Scale when changing the volume.
Step 2. Firmly press and release the Volume button. The volume will
move to the next setting. For example, the Scale may say “one”
and display 1 for Low.
Step 3. Firmly press and release the Volume button again. The volume
moves to the next setting. In this example, the Scale will say “two”
and display 2 for Medium.
Each time your press the Volume button, the volume moves to the next
setting.
Step 4. Stop the procedure when you reach the desired voice volume.
Note
2-26
If you set the volume to 0, there will be no voice prompt and you must
watch the Scale’s display for instruction lights and your weight
measurement.
Philips Telemonitoring Set
Device Usage
Changing
Language
The Standard Scale (only) can speak your weight in either English or
Spanish.
Standard Scale
The procedure for changing the language on the Standard Scale is as
follows:
Step 1. Turn the Scale over to expose its under side, shown in the
following figure.
Language
button
Units
button
Buttons
RJ11 Language KG/LB
See
l ct
Battery
Compartment
RJ11
Language KG/LB
Select
Step 2. Locate the Language Select button in the opening above the
Battery Compartment.
Step 3. Press and release the Language Select button to change the
language.
(Espanol)
The Scalewill speakthe nextlanguage-- Englishor Spanish..
Step 4. Repeat the press and release procedure until the desired language
is spoken.
When the desired language is spoken, the procedure is completed and
that language will be spoken by the scale during weight measurements.
Philips Telemonitoring Set
2-27
Device Usage
Changing
Weight Units
The Scale can measure your weight in either pounds or kilograms. The
procedure for changing the weight units is different for the Standard
Scale and the Steady Scale.
Standard Scale
The procedure for changing the Weight Units on the Standard Scale is
as follows:
Step 1. Turn the Scale over to expose its under side, shown in the
following figure.
Language
button
Units
button
Buttons
RJ11 Language KG/LB
See
l ct
Battery
Compartment
RJ11
Language KG/LB
Select
Step 2. Locate the KG/LB Units button in the opening above the
Battery Compartment.
Step 3. Press and release the KG/LB Units button to change the weight
units.
The Scale will speak the next unit -- Kilograms or Pounds.
[ K i l o g r a m moars L i b r aisn S p a n i s(Espanol)
h.]. ~
Step 4. Repeat the press and release procedure until the desired unit is
spoken.
Step 5. When the desired unit is spoken, the procedure is completed and
that unit will be spoken by the scale during weight measurements.
2-28
Philips Telemonitoring Set
Device Usage
Steady Scale
The procedure for changing the Weight Units on the Steady Scale is as
follows:
Step 1. Step off the Scale when changing the weight units.
Step 2. Firmly press both the Volume button and the Radio Test
button at the same time.
Hold both buttons down for at least 3 seconds.
If the Scale had been measuring pounds, the display will now show
Kgs.
(for kilograms).
If the Scale was measuring kilograms, the scale will now show
Lbs.
(for pounds).
The voice will also say the new weight units (unless the volume is set to
0).
Philips Telemonitoring Set
2-29
Device Usage
Blood
Pressure
Monitor
To get the most accurate and reliable readings from you Blood Pressure
Monitor observe the following guidelines.
• Check the cuff size.
Small cuff fits upper arms 6.3 to 9.4 inches (16 to 24 cm) around.
Standard cuff fits upper arms 9.4 to 14.2 inches (24 to 36 cm)
around
Large cuff fits upper arms 14.2 to 17.7 inches (36 to 45 cm)
around.
• Take your blood pressure at the same time or times each day in a
quiet place.
• Rest 10 minutes before taking your blood pressure.
• Do not take your blood pressure after exertion or drinking coffee or
during conversation.
• Sit within 20 feet of the Home Hub/TeleStation.
• Sit comfortably with uncrossed legs.
• Use the same arm each time.
• Remove any tight clothing on the arm you will use to measure
your blood pressure or roll up a loose garment sleeve.
Do not measure with the cuff over clothing.
• Place the cuff 1 inch above the elbow with the air hose on the
inside of your arm.
• Leave room for two fingers under the cuff.
• Sit still and do not move your arm during the measurement.
Notes
You can lie down while someone else takes your blood pressure, but it is
important to take your blood pressure the same way every time (either
sitting or lying down).
Report any changes in how you take your blood pressure to your
healthcare provider.
If you travel with the BP Monitor, the M3815A will store up to 19
readings for up to 11 days with good batteries that remain in the device.
The M3815B will store up to 25 readings.
When you return home to your Home Hub/TeleStation, the readings will
be sent automatically to your healthcare provider’s computer.
2-30
Philips Telemonitoring Set
Device Usage
Measuring
Blood
Pressure
Note
Two procedures for measuring your blood pressure follow, one for each
of the two Blood Pressure Monitor models available -- M3815A and
M3815B. Select the procedure that matches your BP Monitor.
The BP’s Model number is given on the back side of the monitor.
•
M3815A - BP Monitor with the Radio Test button
on the front of the display.
•
M3815B - BP Monitor with the Radio Test button
on the front of the display.
symbol
symbol
Procedure for M3815A Blood Pressure Monitor
The following table describes symbols
you may see on the M3815A BP
Monitor display during the measurement.
Symbol
Meaning
The blood pressure measurement is taking place.
The symbol blinks and beeps with each pulse beat.
The symbol may also appear briefly at the start of your
blood pressure measurement.
The batteries need to be replaced.
This symbol may also appear briefly at the start of your
measurement.
There may be a problem with your equipment.
Take your blood pressure again.
If there is still a problem, you may be able to fix the
problem by looking in the Troubleshooting section.
If not, call your healthcare provider.
Philips Telemonitoring Set
2-31
Device Usage
The procedure for measuring your blood pressure with the M3815A
Blood Pressure Monitor is as follows:
Step 1. Sit comfortably with your forearm resting on a flat surface and
your legs uncrossed. The center of your upper arm should be at
about the same height as your heart.
Step 2. Put your hand through the
cuff and slide the cuff up your
forearm.
Step 3. Move the cuff so it is on your upper
arm and the bottom of the cuff is about
1 inch above your elbow
Step 4. Position the air hose so it dangles
on the inside of your arm.
Warning
Do not allow the air hose to kink or twist.
Step 5. Pull on the end of the cuff to tighten it.
Then fold the cuff end back over the metal D-ring.
Note
The cuff should be snug but not too tight. Leave room for two fingers to
fit under the cuff.
Step 6. Fasten the end of the cuff to the Velcro ® closure.
Step 7. Make sure that your hand is open and relaxed with the palm up.
Step 8. Press the START/STOP button. The cuff will inflate and feel
tight.
Sit still and do not move your arm during the measurement.
2-32
Philips Telemonitoring Set
Device Usage
Note
If it feels too tight or to stop the measurement at any time:
– Press the START/STOP button.
– Take your blood pressure again.
If you are concerned at any time about the measurement, contact your
healthcare provider.
The BP Monitor will display numbers that go up to just beyond 150
mmHg for the initial pump. It may then resume pumping to higher
pressures.
Warning
Watch the display. If the numbers go up to 330 mmHg, press the
START/STOP button to immediately stop the measurement.
Contact your healthcare provider.
Step 9. As the cuff pressure slowly decreases, watch the display window.
The BP Monitor will beep as the pressure decreases.
Warning
Watch the display.
If the numbers drop down to 15 mmHg and stay there for more than
3 minutes, press the START/STOP button to stop the measurement.
Contact your healthcare provider.
A long beep indicates that your blood pressure has been taken. The cuff
will deflate. The display window shows your final blood pressure and
pulse.
Note
If an error message was displayed, you stopped the reading, or you feel
that the reading may be incorrect, take your blood pressure again.
If this happens a second time, contact your healthcare provider.
Philips Telemonitoring Set
2-33
Device Usage
Step 10. Slide the cuff off you arm.
The BP Monitor will turn off by itself.
Note
Once properly adjusted, the cuff can be slid off without undoing the
Velcro.
Step 11. Store the BP Monitor within 20 feet of the Home Hub/
TeleStation so it can send your readings to the Home Hub/
TeleStation.
Note
2-34
Refer to the Maintenance section for proper storage of your BP
Monitor.
Philips Telemonitoring Set
Device Usage
Procedure for M3815B Blood Pressure Monitor
The following table describes symbols
that you may see on the M3815B BP
Monitor display during the measurement.
Symbol
Meaning
Indicates that a measurement is in progress.
It blinks when detecting the pulse
Battery power full indicator
Battery power low indicator.
If it blinks, the batteries should be replaced
There was a problem with the measurement, such as:
– Unstable blood pressure due to excessive body
movement.
– Pulse not detected correctly.
– Systolic and diastolic values within 10 mmHG
of each other.
Take your blood pressure again, being sure to remain
very still during the measurement.
Cuff is not fastened correctly.
– Refasten the cuff
– Take your blood pressure again.
If there is still a problem, consult the Troubleshooting section for
corrective actions.
If this does not resolve the problem, call your healthcare provider.
Philips Telemonitoring Set
2-35
Device Usage
The procedure for measuring your blood pressure with the M3815B
Blood Pressure Monitor is as follows:
Step 1. Sit comfortably with your left arm resting on a flat surface and
your legs uncrossed. The center of your upper arm should be at
about the same height as your heart.
Step 2. Put your hand through the cuff
and slide the cuff up your forearm.
Step 3. Position the cuff on your upper
arm with the tube facing
downward and toward the inside
of your arm.
Warning
Do not allow the air hose to kink or twist.
Step 4. Fasten the cuff securely with the hook and loop fastener strap.
Note
The cuff should be snug but not too tight. You should be able to insert two
fingers between the cuff and your arm.
Make sure that your hand is open and relaxed with the palm up.
Remain still and do not talk or move your arm during the
measurement.
Step 5. Press the START/STOP button.
All display symbols appear briefly and the display then changes as
the measurement begins.
The cuff starts to inflate to the correct level. It is normal for the cuff
to feel very tight.
Note
2-36
If it feels too tight or to stop the measurement at any time:
– Press the START/STOP button.
– Take your blood pressure again.
If you are concerned at any time about the measurement, contact your
healthcare provider.
Philips Telemonitoring Set
Device Usage
When the inflation is complete, the deflation starts automatically and the
heart symbol
blinks, indicating that the measurement is in
progress.
Once the pulse is detected, the symbol flashes with each pulse beat.
Note
If an appropriate pressure is not obtained, the device automatically starts
to inflate again.
When the measurement is complete, the systolic and diastolic pressure
reading and pulse rate are displayed. The cuff will then deflate and the
BP Monitor automatically shuts off after 45 seconds, or you can turn it
off by pressing the START/STOP button.
Note
If an error message was displayed, you stopped the reading, or you feel
that the reading may be incorrect, take your blood pressure again.
If this happens a second time, contact your healthcare provider.
Step 6. Remove the cuff.
Step 7. Store the BP Monitor within 20 feet of the Home Hub/
TeleStation so it can send your readings to the Home Hub/
TeleStation.
Note
Refer to the Maintenance section for proper storage of your BP
Monitor.
Philips Telemonitoring Set
2-37
Device Usage
Rhythm
Strip
Recorder
The following guidelines should be followed before you take your heart
rhythm to assure an accurate reading.
• Sit down within 20 feet of the Home Hub/TeleStation.
• Relax.
Notes
It is important to be still and relaxed during the rhythm measurement.
You can lie down while you take your heart rhythm.
It is important to take your heart rhythm the same way every time (either
sitting or lying down).
Report any changes in how you take your heart rhythm to your healthcare
provider.
If you travel with your Recorder, it will store the most recent reading for
up to 11 days with good batteries that remain in the device.
When you return home to your Home Hub/TeleStation, the most recent
reading will be sent automatically to your healthcare provider’s computer.
Caution
Do not talk or move during the measurement.
Measuring
Heart Rhythm
The procedure for measuring your Heart Rhythm is as follows:
Step 1. Sit back in a chair with your arms at your sides or on the chair
arms. Do not cross your legs. Keep your feet flat on the floor.
Step 2. Place the Recorder on the table next to you so you can see it and
listen to it without moving. If you have to move to see or hear the
Recorder, place the Recorder in your lap.
Step 3. Place the wristband with the white snap-on connector on your
right wrist. Make sure that the flat metal inside of the wristband
(on the other side of the black plastic pad) firmly touches the inside
of your wrist.
Step 4. Place the wristband with the red snap-on connector on your left
wrist. Make sure that the flat metal inside the wristband (on the
other side of the black plastic pad) firmly touches the inside of your
wrist.
2-38
Philips Telemonitoring Set
Device Usage
Notes
If the wristbands are loose, push them up each forearm until they feel
snug.
Be careful not to snag the hair on your arms.
Do not put the wristbands over clothing, bandages, or jewelry.
If you cannot fit the wristband on your arm, contact your healthcare
provider.
Step 5. Let your hands rest on the tabletop or your chair’s arms so that
your hands are open relaxed, and palms up.
Step 6. Press the START button.
The relax light will flash on and
off, and the Recorder will beep for
about 20 seconds as the
measurement is being made.
Notes
relax
Rhythm
Strip
Recorder
START
If the Recorder beeps twice quickly before beginning the normal beeping,
this means that the batteries are low. Replace the batteries within a week.
The beeps do not reflect your heart rate. They indicate that the Recorder
is working.
After another short pause, the relax light flashes on and off twice and
the Recorder will quickly beep twice. The Recorder has finished taking
your heart rhythm.
Step 7. Remove the wristbands. The Recorder will turn off by itself.
Step 8. Store the Recorder within 20 feet of the Home Hub/TeleStation
so it can send you measurements to the Home Hub/TeleStation.
Note
Refer to the Maintenance section for proper storage of your Rhythm
Strip Recorder.
Philips Telemonitoring Set
2-39
Device Usage
Pulse
Oximeter
Caution
2-40
To get the most accurate readings from you Pulse Oximeter, observe the
following guidelines:
•
The Pulse Oximeter may not work properly with a finger thickness
of less than 5/16 inches (0.8 cm) or more than 1 inch (2.5 cm).
•
Dark colored nail polish or artificial nails will prevent the Pulse
Oximeter from making accurate measurements. Remove dark nail
polish and artificial nails from the finger you use to take your
measurement.
•
Avoid exposing the finger sensor to very bright or changing light
while taking your measurement.
•
Do not use your Pulse Oximeter on the same arm during or
immediately after taking your blood pressure. Use your other arm
or take your Pulse Oximeter measurement first.
•
Use the same finger each time you make a measurement unless
your healthcare provider instructs otherwise.
•
Do not use the sensor on a finger that has chronically poor
circulation or is injured.
•
Be sure the inside of the finger sensor is dry before taking your
measurement.
•
Be sure your finger is warm when you take your measurement. If
your finger is cold, warm or rub it before taking your measurement.
•
Carefully place your finger in the sensor as far as it will
comfortably go. Do not press in so far that you can feel your finger
throbbing.
•
Keep you finger relaxed and still while taking your measurement.
•
If you have anemia, a low hemoglobin count, or arrhythmias, you
may not be able to get a correct reading. Contact your healthcare
provider.
Do not use the Pulse Oximeter with the battery door open.
Philips Telemonitoring Set
Device Usage
Measuring
Blood
Oxygen and
Pulse Rate
Note
Two procedures for measuring your blood oxygen level (%SpO2) and
pulse rate follow, one for each of the two Pulse Oximeter models
available -- M3814A and M3814B. Select the procedure that matches
your Pulse Oximeter.
The Pulse Oximeter Model number is given on the back of the device.
•
M3814A - Pulse Oximeter with the Radio Test button
symbol on the front of the display.
•
M3814B - Pulse Oximeter with the Radio Test button
symbol on the front of the display.
Procedure for M3814A Pulse Oximeter
The following steps describe how to use the M3814A Pulse Oximeter to
measure your blood oxygen level (%SpO 2) and pulse rate. By default,
pulse rate is turned off. To turn pulse on, press and hold both the START
and test
buttons for more than 3 seconds. Repeating this step will
turn pulse off again.
Step 1. Sit within 20 ft. of the Home Hub or TeleStation with your hand
resting on a flat surface and the Pulse Oximeter in front of you.
Step 2. Open the sensor and fully insert
your finger (index, middle, or ring,
but not your thumb) until the end of
your finger reaches the finger stop.
The cable should extend over your
finger toward your wrist as shown
in the figure.
Step 3. Sit comfortably with your hand
resting on the surface so that it
can remain still.
Philips Telemonitoring Set
2-41
Device Usage
Step 4. Press the START button and hold your hand still during the
measurement.
Press Start button
Hold hand still
The measurement process is as follows:
- Dashes move across the display
during measurement.
%SpO2
pulse (/min)
- A double beep sounds after a
few seconds indicating that the
measurement is complete
- A tick sounds as the
% SpO2 measurement
displays and the yellow
light next to % SpO2
illuminates.
2-42
Philips Telemonitoring Set
%SpO2
pulse (/min)
Device Usage
- A tock sounds as the pulse
rate displays and the green
light next to pulse (/min.)
illuminates.
- The tick-tock sequence repeats
several times and then turns off.
Note
%SpO2
pulse (/min)
If the measurement was not made, a long beep sounds and
displays:
Warm your hand or use a different finger and try again.
Philips Telemonitoring Set
2-43
Device Usage
Procedure for M3814B Pulse Oximeter
The following steps describe how to use the M3814B Pulse Oximeter to
measure your blood oxygen level (%SpO 2) and pulse rate. By default,
pulse rate is turned off. To turn pulse on, press and hold both the
START/STOP and test buttons
for more than 3 seconds.
Repeating this step will
turn the pulse rate display off again.
Step 1. Sit within 20 ft. of the Home Hub or TeleStation with your hand
resting on a flat surface and the Pulse Oximeter in front of you.
Step 2. Open the sensor and fully insert
your finger (index, middle, or ring,
but not your thumb) until the end of
your finger reaches the finger stop.
The cable should extend over your
finger toward your wrist as shown
in the figure.
Step 3. Sit comfortably with your hand resting on the surface so that it
can remain still. Press the START/STOP button and hold your
hand still during the measurement
Press
START/STOP
button
Hold hand still
2-44
Philips Telemonitoring Set
Device Usage
The measurement process is as follows:
- Dashes move across the display
during measurement.
%SpO2
Pulse
/min
Note: If the depleted battery symbol
flashes on/off, replace the
batteries and repeat the measurement. See Replacing Batteries on
page 3-12.
- After several seconds, the
%SpO 2 measurement and
Pulse /min rate display
%SpO2
Pulse
/min
Note: The Pulse rate may not display if it was not turned on by your
healthcare provider.
- After 15 seconds the Pulse Oximeter turns off.
Philips Telemonitoring Set
2-45
Device Usage
Note
If the measurement was not made, the display shows
, as shown opposite.
Warm your hand or use a different finger
and try again.
If there is a problem, the display shows
as shown opposite and then goes blank.
Warm your hand or use a different finger
and try again.
If it still shows
provider.
2-46
Philips Telemonitoring Set
, contact your healthcare
Device Usage
Glucose
Meter
The TeleStation can record results from some Glucose Meters. Glucose
Meter readings cannot be made with a HomeHub. The following Glucose
Meters are approved for use with the TeleStation:
• Bayer Ascensia Contour 7151B
• OneTouch Basic
• OneTouch Profile
Warning
Glucose Meter readings can be recorded only on a TeleStation. this
function is not available with a Home Hub.
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.
Recording
Glucose
Measurements
Follow these steps to send your Glucose Meter measurements to your
healthcare provider’s computer via the TeleStation:
Step 1. Measure your glucose with your Glucose Meter following the
procedures given in its User Guide.
Step 2. Wait for the meter to turn off. The meter will turn off
automatically when the strip is discarded.
For the Bayer Ascensia Contour meter, this can take 3 minutes.
OneTouch meters will stay on and should be left on.
Step 3. Clean your finger of any residual blood before the next step.
Step 4. Connect the large end of the Glucose Meter Cable to the.
connector marked | 0 | 0 | on the back of the TeleStation. The
Glucose Meter may already be connected.
Philips Telemonitoring Set
2-47
Device Usage
Step 5. Connect the single pin connector on the other end of the
Glucose Meter Cable into the data port on the Glucose Meter. Press
firmly to make sure the connector is pushed in all the way. The
TeleStation will not detect the Glucose Meter until the meter is
turned on.
Note
The Glucose Meter Cable for the Bayer Ascensia Contour 7151B
glucose meter is different from the Cable for the OneTouch Basic and
OneTouch Profile glucose meters. See the following figure
TeleStation
Bayer
Ascensia
Glucose
Meter
Single Pin
Connector
Glucose
Meter
Cable
OneTouch
Ultra & Profile
Glucose
Meters
Step 6. Turn the Glucose Meter on (OneTouch meters should already be,
see Step 2). The TeleStation will detect the Glucose Meter and
2-48
Philips Telemonitoring Set
Device Usage
connect automatically. The Glucose Meter sends the results to the
Telestation and then turns off automatically.
The TeleStation will display a message “Please Disconnect Glucose
Meter”.
Step 7. Disconnect the cable from the Glucose Meter. If using the Bayer
Ascensia Contour 7151B, the cable can be left connected to the
TeleStation.
Changing
Glucose
Meter Time
and Date
The TeleStation relies on the date and time set in the Glucose Meter.
This gives the clinician the most accurate date and time of measurement.
Therefore it is important for the Glucose Meter’s date and time to be set
correctly. If it is necessary to correct the date or time in your Glucose
Meter, follow the steps below to ensure that the date and time of your
glucose measurements are accurate when you transmit them via the
TeleStation.
Step 1. Connect your Glucose Meter to the TeleStation and transmit the
results as described above.
Step 2. Clear the Glucose Meter’s memory of all readings.
Step 3. Change the time and/or date on your Glucose Meter following the
procedure described for the unit.
Philips Telemonitoring Set
2-49
Overview
Chapter 3 provides steps for cleaning and storing Patient
Telemonitoring devices, replacing batteries, and general maintenance of
the Patient Telemonitoring Set. You can help keep your devices in
working order by taking good care of them.
This chapter includes the following sections:
Page
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
Standard Scale . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Steady Scale. . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Blood Pressure Monitor . . . . . . . . . . . . . . . 3-9
Rhythm Strip Recorder . . . . . . . . . . . . . . 3-11
Pulse Oximeter . . . . . . . . . . . . . . . . . . . . 3-12
Maintenance
3-1
Introduction
Maintenance
Cleaning Devices
Cleaning Devices
Telemonitoring devices should be cleaned only when necessary. The
following procedure should be followed to clean the devices.
Note
Body fluids, such as blood or mucus, should be promptly removed using
a cloth dampened with plain tap water (no soap).
Caution
Avoid spilling liquids on the devices.
Do not immerse devices in liquids to clean.
Do not use alcohol. harsh chemicals, caustic, or abrasive cleaning
agents to clean devices.
Step 1. Unplug the Home Hub/TeleStation from power and phone lines.
Step 2. Remove batteries from the measurement devices following
procedures given in the Replacing Batteries section.
Step 3. Clean all exposed device surfaces with a dry, soft cloth.
Note
When cleaning the Pules Oximeter:
– Open the Finger-clip sensor and carefully wipe its inside surfaces
with a cloth dampened with a mild detergent.
– Allow the sensor to dry thoroughly before using.
Step 4. Plug the Home Hub/TeleStation back into power and phone
lines.
Step 5. Reinstall batteries into the measurement devices following
procedures given in the Replacing Batteries section.
3-2
Maintenance
Storing Devices
Storing Devices
All measurement devices should be stored within 20 feet of the Home
Hub or TeleStation so they can send their results to the Home Hub or
TeleStation.
Caution
Do not store devices inside or next to a metal drawer or container, such
as a file cabinet.
Do not store devices where children or pets could get tangled in the
hoses, dual cables. or wristband assemblies.
Blood
Pressure
Monitor
Rhythm Strip
Recorder
Pulse
Oximeter
•
Store the BP Monitor so that the hose and cuff assembly are not
bent, twisted, or folded tightly.
•
Do not wrap the hose around the display case.
•
Store the Rhythm Strip Recorder so that the cable is not twisted or
folded tightly.
•
The Recorder can be stored with its connectors attached to the
wristbands.
•
Store the Pulse Oximeter so that its sensor cable is not twisted or
kinked.
•
Avoid tugging at the sensor cable or carrying the Pulse Oximeter
by the sensor cable.
Maintenance
3-3
Replacing Batteries
Replacing Batteries
Batteries in devices should be replaced as soon as the device indicates
that they are low or need to be replaced.
Caution
When replacing batteries, replace all of the batteries with new ones
at the same time.
Use only Type AA (1.5 volt) alkaline batteries
Do not use rechargeable batteries.
Warning
Do not use any device with its battery door removed.
Scale
Replace the batteries in the Standard Scale every 12 months
or sooner if:
• the voice prompt is absent even though the volume was not set to 0
• the display screen alternately displays Lo and batt during a
measurement
• the Scale announces "Please replace the scale batteries" during
a measurement.
Replace the batteries in the Steady Scale every 6 months
or sooner if:
• the voice prompt is absent even though the volume was not set to 0
• the normally steady Stand Still light display flashes.
Both Scales use 4 AA alkaline batteries.
Procedures
3-4
Maintenance
Procedures for replacing batteries in the Standard Scale and Steady Scale
are as follows. Use the procedure for your type of scale.
Replacing Batteries
Standard Scale
Step 1. Lift and gently turn the scale upside down on a flat surface to
expose the Battery Compartment.
Lift tab and
remove cover
RJ11 Language
See
l ct
KG/LB
Battery
Compartment
Step 2. Remove the cover of the Battery Compartment by lifting the tab.
Step 3. Remove the old batteries and properly dispose of them.
Note
Check with your local authorities for the proper way to dispose of
batteries.
Step 4. Place the new batteries in the Battery Compartment so that the
positive (+) and negative (-) terminals match the diagram in the
compartment.
Notes
Make sure that battery terminals are touching compartment terminals.
Maintenance
3-5
Replacing Batteries
Step 5. Replace the cover by inserting its tabs into the slots and gently
pressing the cover into place.
Step 6. Return the Scale to its original spot following proper lifting
techniques given below.
Note
Lifting the Scale requires good balance, the ability to grasp and lift up to
10 pounds, and safe lifting techniques.
Do not lift the Scale if you are unsteady or unable to follow proper
lifting techniques. Ask for assistance or contact your healthcare
provider for help.
When you lift or lower the Scale:
– Wear shoes with nonslip soles.
– Keep your feet apart and one foot a bit in front of the other, if
possible.
– Squat to lift and lower the Scale. Never bend at the waist.
– Keep the Scale close to your body.
–
Lift with your legs, not your back.
– If you must turn, turn with your feet not your body.
Step 7. Perform the Radio Test described in the Troubleshooting
section.
Step 8. Step on the Scale and verify that it is working properly.
Note
3-6
If the Scale does not seem to be operating properly or the Radio Test
fails, contact your healthcare provider.
Maintenance
Replacing Batteries
Steady Scale
Step 1. Firmly hold the display and pull it from the Scale to release it
from the plastic fastener strips that hold it in place.
Step 2. Turn the display over and unplug the cord inside the top of the
column.
Step 3. Gently push the Battery Compartment cover in the direction of
the arrow symbol and lift it off.
Step 4. Remove the old batteries and properly dispose of them.
Note
Check with your local authorities on the proper way to dispose of
batteries.
Step 5. Place the new batteries in the Battery Compartment so that the
positive (+) and negative (-) terminals match the diagram in the
compartment.
2. Insert top row second
1. Insert bottom row first
Notes
To keep the batteries from popping out, insert the bottom row first.
Make sure that the battery terminals are touching the compartment
terminals.
Step 6. Replace the cover by inserting its tabs into the slots and gently
pressing the cover into place.
The Stand Still and Step Off lights will turn on for about 6 seconds,
then turn off. If the device is face down, you may not see these lights.
Maintenance
3-7
Replacing Batteries
The display will then show
flash slowly.
briefly, and the Step Off light will
Step 7. Replace the display as follows:
– Place the connection cord through the display cutout.
– Hold the scale display above the top of the column with the
display facing you.
– Plug the cord into the adapter inside the top of the column.
– Center the display over the top of the column so that the plastic
fastener strips on the display and the column match.
– Press down on the display. The back of the display should rest
against the rim on the top of the column.
When the display is properly connected to the Scale:
– the Step Off light stops flashing.
– the Scale will say “zero pounds”, display 0.0, and then turn off.
Note
Important: Do not step on the Scale while doing this step.
If the Step Off light does not stop flashing, check the cord connections
by unplugging the cord and replugging it in until it snaps into place.
Also check that the batteries are inserted the right way.
Step 8. Return the Scale to its original spot.
Caution
Do not lift the Steady Scale.
If the Steady Scale must be moved, ask for assistance or call your
healthcare provider for help.
Step 9. Perform the Radio Test described in the Troubleshooting
section.
Step 10. Step on the Scale and verify that it is working properly.
Note
3-8
If the Scale does not seem to be operating properly or the Radio Test
fails, contact your healthcare provider.
Maintenance
Replacing Batteries
Blood
Pressure
Monitor
•
•
•
Procedure
Replace the batteries in the Blood Pressure Monitor every 3 months
or sooner if required. The expected battery life for the BP Monitor
is approximately 3 months with 1 daily reading.
Replace the batteries in the BP Monitor when you see the Low
Battery symbol on the BP Monitor display.
The Blood Pressure Monitor uses 4 AA alkaline batteries.
To replace the batteries in the BP Monitor:
Step 1. Turn the display over.
Step 2. Gently push the Battery Compartment cover in the direction of
the arrow symbol and lift it off.
Step 3. Remove the old batteries and throw them away.
Note
Check with your local authorities on the best way to recycle or throw
away batteries.
Step 4. Place the new batteries in the Battery Compartment so that the
positive (+) and negative (-) terminals match the diagram in the
compartment. Diagrams for both the M3815A and M3815B units
are shown following.
M3815A
2. Insert top row second
1. Insert bottom row first
Notes
To keep the batteries from popping out, insert the bottom row first.
Make sure that the battery terminals are touching the compartment
terminals.
Maintenance
3-9
Replacing Batteries
M3815B
2 . In
to
ert
1. I
nd
eco
p ro
rt b
nse
ow
mr
o tto
firs
Step 5. Replace the cover by inserting its tabs into the slots and gently
pressing the cover into place.
Step 6. Perform the Radio Test described in Troubleshooting.
Step 7. Take your Blood Pressure and verify that it is working properly.
Note
3-10
If the Blood Pressure Monitor does not seem to be operating properly or
the Radio Test fails, contact your healthcare provider.
Maintenance
Replacing Batteries
Rhythm
Strip
Recorder
•
•
•
Procedure
Replace the batteries in the Rhythm Strip Recorder every 6 months
or sooner if required.
If the Rhythm Strip Recorder beeps twice quickly before beginning
normal on and off beeping, the batteries are low and should be
replaced within a week.
The Rhythm Strip Recorder uses 4 AA alkaline batteries.
To replace the batteries in the Rhythm Strip Recorder, follow the
procedure for the Blood Pressure Monitor on page 3-9, except for Step 7.
The Recorder will make a series of beeps.
If the series ends with a rising tone, the batteries have been inserted
correctly.
If the series ends with a falling tone or no tone, the batteries have
been inserted the wrong way. Repeat the battery insertion steps.
After Step 6:
Step 7. Measure your heart rhythm with the Rhythm Strip Recorder to
verify that it is working properly.
Note
If the Rhythm Strip Recorder does not seem to be operating properly or
the Radio Test fails, contact your healthcare provider.
Maintenance
3-11
Replacing Batteries
Pulse
Oximeter
•
Replace the batteries in the Pulse Oximeter every 6 months or
sooner if required.
•
Batteries should be replaced when the Low Battery indicator
displays:
•
Procedure
– on the M3814A,
flashes on the Pulse Oximeter display
– on the M3814B,
Pulse /min display.
flashes on the Pulse Oximeter’s
The Pulse Oximeter uses 4 AA alkaline batteries.
To replace the batteries in the Pulse Oximeter, follow Step 1 through
Step 5 of the procedure for the Blood Pressure Monitor on
page 3-9.
After battery replacement:
•
M3814A displays the message
If the message
appears, replace the batteries with known
good batteries and try again.
•
M3814B self tests for 6 seconds, after which the
full battery symbol appears on the lower display
for 5 seconds.
If the depleted battery symbol flashes, replace the
batteries with known good batteries and try again.
After Step 5:
Step 6. Take your Pulse Oximeter measurement and verify that it is
working properly.
Note
3-12
If the Pulse Oximeter does not seem to be operating properly, contact your
healthcare provider.
Maintenance
Overview
Chapter 4 describes procedure to follow if you have problems with any
of the Philips Telemonitoring Set. The tables on the following pages can
serve as a guide to help resolve problems that may occur.
Caution
Do not try to repair any device yourself.
If a problem cannot be resolved using the procedures given in this
chapter, contact your healthcare provider.
Each device provides an error message when some part of the system is
not working properly. If you see an error message on a device, the first
thing to do is to check the device and try the measurement again. Be sure
to follow the voice and light prompts provided by the device to assure
that the measurement is being made properly.
This chapter includes the following sections:
Page
Radio Test . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Troubleshooting Tables. . . . . . . . . . . . . . . . .
Home Hub/Telestation. . . . . . . . . . . . . . . .
Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4-2
4-3
4-3
4-8
Standard Scale . . . . . . . . . . . . . . . . . . . . . . 4-8
Steady Scale . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Rhythm Strip Recorder . . . . . . . . . . . . . . 4-10
Blood Pressure Monitor . . . . . . . . . . . . . . 4-11
Pulse Oximeter . . . . . . . . . . . . . . . . . . . . 4-13
Troubleshooting
4-1
Introduction
Troubleshooting
Overview
Radio Test
If the data/holding results light does not come on after you take a
measurement, another step that can be taken is to perform a Radio Test.
The Radio Test makes sure that your measurements are being properly
sent from the measurement device to the Home Hub/TeleStation. The
RADIO TEST button, {
or
}, is on the front of the device.
To perform the Radio Test, follow these steps:
Step 1. 1. Press and hold down the RADIO TEST button on the
measurement device for 3 to 5 seconds or until the Home Hub/
TeleStation starts beeping.
Note
If the using phone light on the Home Hub/TeleStation lights, stop and
wait until it turns off before performing the Radio Test.
The following messages will appear on the indicated device.
The Scale and Pulse Oximeter will display rF.
The Rhythm Strip Recorder’s RELAX light will flash once per
second.
The Home Hub/TeleStation should beep:
If the Home Hub/TeleStation does not beep, do the following:
– Make sure the measurement device has fresh batteries
– see if there are any large objects between the measurement
device and the Home Hub/TeleStation.
If there are large objects, move the measurement device to a
different location.
If there are no large objects, move the measurement device
closer to the Home Hub/TeleStation.
– Make sure there are no cordless or cellular telephones or
computers in use near the Home Hub/TeleStation.
– Repeat the Radio Test
If the Radio Test is still not successful, refer to the following
Troubleshooting tables to try to further resolve the problem
4-2
Troubleshooting
Troubleshooting Tables
Troubleshooting Tables
The following tables gives possible Problems that can occur,
Reasons why they may have occurred, and Possible Solutions that
should be tried to resolve the problem.
Find the Problem entry that seems to describe what you observe, and
then try the various Possible Solutions. If none of the solutions seem
to be successful, contact your healthcare provider for additional
suggestions.
Caution
Do not try to repair any device yourself.
If a problem cannot be resolved using the procedures given in this
section, contact your healthcare provider.
Home Hub/
Telestation
The following table describes problems that may occur with the Home
Hub or TeleStation.
Problem
Reason
Possible Solutions
The screen is
unreadable
The Home Hub/TeleStation
may be hot from sitting in
sunlight or storage at a high
temperature
Let the Home Hub/TeleStation cool to room
temperature and the screen display may be
restored.
When taking a
measurement, the
data/holding
results light does
not turn on
There may be interference
from electronic devices, such
as cordless or cell phones or
computers.
Move any electronic devices away from the
Home Hub/TeleStation
The measurement device may
be too far from the Home
Hub/TeleStation
Move the measurement device closer to the
Home Hub/TeleStation.
Perform the Radio Test to determine if the
device signals are being received by the
Home Hub/TeleStation
Troubleshooting
4-3
Troubleshooting Tables
Problem
Reason
Possible Solutions
When you take a
measurement, the
data/holding results
light remains on
There may be a problem with
your telephone service or
your healthcare provider’s
connection
Perform the CALL button test as follows:
- Find the CALL button on the far right of
the back panel of the Home Hub/
TeleStation
- Press the CALL button for less than 2
seconds. The Home Hub/TeleStation
should beep once.
(For some Home Hubs, you may need to
use a pen or other pointed object to depress
the CALL button)
- Release the CALL button.
- In 10 seconds, the using phone light
should turn on and the Home Hub/
TeleStation will dial your healthcare
provider.
- After a few minutes, the using phone
light and the data/holding results light
should turn off.
- If the data/holding results light turns
off, the Home Hub/TeleStation is operating
correctly. (It may take a few minutes for it
to turn off.)
- If the results above do not occur, contact
your healthcare provider.
4-4
Troubleshooting
Troubleshooting Tables
Problem
Reason
Possible Solutions
When you take a
measurement, the
data/holding
results light
remains on
and you have a
special phone service
such as voice mail
There may be a conflict
between your special phone
service and the Home Hub/
TeleStation connection,
or a problem with your
telephone line or your
healthcare provider’s
connection.
- Have someone call and leave a message on
your special telephone service
Perform the CALL button test as follows:
Note: Keep your phone on the hook for
the following steps unless told otherwise.
- Find the CALL button on the far right of
the back panel of the Home Hub/
TeleStation
- Press the CALL button for less than 2
seconds. The Home Hub/TeleStation
should beep.
(For some Home Hubs, you may need to
use a pen or other pointed object to depress
the CALL button)
- Release the CALL button.
- In 10 seconds, the using phone light
should turn on and the Home Hub/
TeleStation will dial your healthcare
provider.
- After a few minutes, the using phone
light and the data/holding results light
should turn off.
- If the data/holding results light is still
on, listen to the saved message and then
delete it.
- Press the CALL button for less than 2
seconds. The Home Hub/TeleStation
should beep once.
- Release the CALL button.
- In 10 seconds, the using phone light
should turn on and the Home Hub/
TeleStation will dial your healthcare
provider.
Troubleshooting
4-5
Troubleshooting Tables
Problem
Continued from
previous page
Reason
Possible Solutions
- After a few minutes, the using phone
light and the data/holding results light
should turn off.
- If the data/holding results light turns
off, the Home Hub/TeleStation is operating
correctly. (It may take a few minutes for it
to turn off.)
However, your special phone service may
be interfering with the Home Hub/
TeleStation
- If the data/holding results light stays
on, there is probably not a conflict with
your special phone service.
However, there may be a problem with
your phone line or your healthcare
provider’s connection.
- If the results above suggest a problem,
contact your healthcare provider.
4-6
Troubleshooting
Troubleshooting Tables
Problem
Reason
Possible Solutions
Liquid spilled onto
the Home Hub/
TeleStation
(for example, where
the wires connect to
the back)
The Home Hub/TeleStation
should be placed far from
liquids (especially a sink or
anywhere liquids might spill
onto the unit.)
For liquid spills, do the following:
- Unplug the Home Hub/TeleStation power
adapter from the wall or power strip.
- Unplug the phone connection cord from the
wall jack.
- Use a towel to dry off the Home Hub/
TeleStation, paying special attention to
connection points.
- Wait 3 hours for the unit to completely dry.
- Plug the connection cords back into the
Home Hub/TeleStation and the electrical
and phone lines. Make sure they snap into
place.
- Pick up your telephone receiver and listen
for a dial tone.
- If you do not hear a dial tone, hang up and
try again.
- If you still do not hear a dial tone, unplug
the Home Hub/TeleSTation.
- Connect your telephone directly to the
phone jack.
- Contact your healthcare provider.
Troubleshooting
4-7
Troubleshooting Tables
Scale
Standard
Scale
The following table describes problems that may occur with the each of
the two types of Scale -- Standard Scale and Steady Scale. Use the table
for your type of Scale.
The following troubleshooting table applies to the Standard Scale.
Problem
Reason
Possible Solutions
Err.1 appears on the display You may have stepped off
and it says "Please try again." the Scale too soon.
Take your weight again and wait for the
voice prompt before stepping off the
Scale.
Err.2 appears on the display You may have moved
and it says "Please try again." during the measurement
Take your weight again and do not move
while the scale measures your weight
Err.3 appears on the display You may have stayed on the Take your weight again and step off the
and it says "Please try again." scale too long.
scale as soon as you hear the voice
prompt.
Err.4 appears on the display
and it says "The maximum
weight was exceeded."
Your may have exceeded
the maximums weight of
440 lbs (200 kgs)
Use a regular scale to see if your weight
exceeded 440 lbs (200 Kg).
No voice prompt when you
stand on the Scale and it is not
set to 0
The display alternately flashes The Scale’s batteries are
Lo and batt
low.
Replace all 4 batteries in the Scale as
described in Chapter 3
The Scale announces "Please
replace the scale batteries"
Scale does not turn on.
The Scale is not properly
- Replace all 4 Scale batteries following
installed or the batteries are the procedure in Chapter 3.
low.
- Move the Scale to a hard, flat surface.
- If it still des not turn on, contact your
healthcare provider.
The final weight reading keeps The Scale is on a carpeted
changing or is incorrect.
or irregular surface, or the
Scale is broken.
4-8
Troubleshooting
- Move the Scale to a hard, flat surface
and take your weight again.
- If this does not resolve the problem,
contact your healthcare provider.
Troubleshooting Tables
Steady Scale
The following troubleshooting table applies to the Steady Scale.
Problem
Reason
Possible Solutions
Err. appears on the
display
You stepped off the Scale too
soon.
Take your weight again and wait for the Step
Off light and voice prompts before stepping
off the Scale.
Err.1 or
Err.2 or
Err.6 appears on the
display
The Scale display is not
connected to the Scale
Check the connection of the display to the
Scale.
or there is a problem with the
Scale
If this does not resolve the problem, contact
your healthcare provider.
Err.3 appears on the
display
You moved the scale
Take your weight again and wait for the Step
immediately after stepping off. Off light and voice prompt before stepping off
the Scale and do not touch the Scale.
Err.4 appears on the
display
You moved during the weight Take your weight again and remain still
measurement.
during the measurement.
Err.5 appears on the
display
The Scale was unable to read
the measurement.
Use a regular scale to see if your weight
exceeded 365 lbs (166 Kg)
Err.6 appears on the
display
You did not step off the Scale
when prompted.
Take your weight again and when the Step
Off light and voice prompt occur, step off the
Scale.
Stand Still light
The Scale’s batteries are low.
blinks when you stand
on the Scale.
Replace all 4 batteries in the Scale as
described in Chapter.3
Stand Still light
The Scale’s batteries are low.
blinks and there is no
voice prompt when
you stand on the
Scale and it is not set
to 0.
Replace all 4 batteries in the Scale as
described in Chapter.3
Step Off light
flashes slowly
- Check the cord connection between the
platform and the display
The Scale display is not
connected to the Scale.
- Unplug and replug the cord until it snaps
into place
Troubleshooting
4-9
Troubleshooting Tables
Problem
Reason
Possible Solutions
Scale does not turn
on.
The Scale is not properly
installed or the batteries are
low.
- Check the cord connection between the
platform and the display.
- Replace all 4 Scale batteries following the
procedure in Chapter 3.
- Move the Scale to a hard, flat surface.
- If it still des not turn on, contact your
healthcare provider.
The final weight
reading keeps
changing or is
incorrect.
Rhythm
Strip
Recorder
The Scale is on a carpeted or
irregular surface, or the Scale
is broken.
- Move the Scale to a hard, flat surface and
take your weight again.
- If this does not resolve the problem, contact
your healthcare provider.
The following table describes problems that may occur with the Rhythm
Strip Recorder.
Problem
Reason
Possible Solutions
Poor heart rhythm
measurement, or
the Home Hub/
TeleStation is not
receiving the heart
rhythm
measurement.
The wrist bands are too loose
or not properly positioned.
Push the wristbands up you arms until there
is a smooth, snug fit against the skin or you
inner wrists or arms.
The measurement device may
be too far from the Home
Hub/TeleStation
- Move the measurement device closer to the
Home Hub/TeleStation.
- Perform the Radio Test to determine if the
device signals are being received by the
Home Hub/TeleStation.
- If the Recorder is still not operating
properly, contact your healthcare provider.
4-10
Troubleshooting
Troubleshooting Tables
Blood
Pressure
Monitor
The following tables describes problems that may occur with the Blood
Pressure Monitor The first table is for the M3815A and the second
table is for the M3815B.
M3815A
Problem
Reason
Possible Solutions
Inaccurate blood
pressure readings.
Improper blood measurement
procedure.
Review the blood pressure tips in Chapter 2
and repeat the measurement.
The systolic and diastolic
measurements are within
10 mm Hg of each other.
There may be air leakage in
the air hose connections.
- Check that the air hose is properly
connected to the BP Monitor and cuff by
unplugging it and then plug it back in,
pushing and twisting until it snaps into
place.
appears on
the display
You moved during the
reading.
- Take your blood pressure again, remaining
very still during the reading.
appears on
the display
The pressure measurement
did not increase during cuff
inflation or the cuff is not
securely fastened.
- Check that the air hose is properly
connected to the BP Monitor and cuff by
unplugging it and then plug it back in,
pushing and twisting until it snaps into
place.
appears on
the display
- Make sure the cuff is securely fastened
appears
on the
display
The BP Monitor batteries are
low.
- Replace all 4 batteries in the BP Monitor
following the procedure in Chapter 3.
Note: If the batteries need frequent
replacement, check the initial snugness of
the cuff. A loose cuff requires longer
pumping times and will shorten battery life.
Troubleshooting
4-11
Troubleshooting Tables
M3815B
Display Symbol
4-12
Troubleshooting
Reason
Possible Solutions
Battery power full indicator
No action required.
Battery power low indicator
When battery power indicator blinks, replace
all batteries with new ones.
Unstable blood pressure due
to excessive body movement.
Repeat the measurement and remain very still
during the measurement.
Pulse is not detected
correctly.
Repeat the measurement and remain very still
during the measurement.
Systolic and diastolic values
are within 10 mmHG of each
other.
Refasten the cuff and repeat the measurement
remaining very still during the measurement.
Pressure value did not
increase during inflation.
Check for air leaks along the tube and around
the air socket.
Cuff is not fastened correctly.
Refasten the cuff and repeat the
measurement.
Troubleshooting Tables
Pulse
Oximeter
The following tables describes problems that may occur with the Pulse
Oximeter. The first table is for the M3814A and the second table is for
the M3814B.
M3814A
Problem
Reason
Possible Solutions
appears on
the display
A hardware malfunction is
detected.
If condition persists, contact your healthcare
provider.
appears
on the
display
A reading was not obtained.
appears
on the
display
Batteries are too low for the
Pulse Oximeter to work
properly.
- Replace all 4 batteries following the
procedure in Chapter 3.
- Perform a Radio Test.
appears
on the
display
along with a rising
audio tone after
battery replacement
Indicates that the batteries are
good.
No action required. Proceed with Pulse
Oximeter measurement.
appears
on the
display
along with a low
audio tone after
battery replacement.
There is a hardware
malfunction.
- Replace all 4 batteries following the
procedure in Chapter 3.
- Perform a Radio Test.
- If condition persists, contact your
healthcare provider.
and flashes.
Reduce the light.
Warm your finger.
Keep your hand still.
Repeat the measurement.
If the condition persists, contact your
healthcare provider.
Troubleshooting
4-13
Troubleshooting Tables
M3814B
Problem
Reason
Possible Solutions
appears on
the display
A hardware malfunction is
detected.
If condition persists, contact your
healthcare provider.
appears on
the display
A reading was not obtained.
appears on
the display
and flashes
Batteries are too low for the
Pulse Oximeter to work
properly.
- Replace all 4 batteries following the
procedure in Chapter 3.
- Perform a Radio Test.
Reduce the light.
Warm your finger.
Keep your hand still.
Repeat the measurement.
If the condition persists, contact your
healthcare provider.
appears on Indicates that the batteries are
the display good.
during start
up and after
battery replacement
No action required. Proceed with Pulse
Oximeter measurement.
No Pulse rate appears on the The Pulse rate function is
display after a measurement. normally turned off.
Your healthcare provider can turn the
Pulse rate function on if necessary or
applicable.
4-14
Troubleshooting
Overview
Chapter 5 provides information about the Philips Telemonitoring Set of
devices that is required by law to completely describe their characteristics,
performance and compliance with regulatory requirements. It includes the
following sections.
Page
Intended Use/Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Home Hub . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 Electro-magnetic Interference . . . . . . . . . . . . . . 5-12
Avoiding Static Electrical Discharges . . . . . . . . . . . . . . . . 5-13
Electromagnetic Compatibility (M3813B and M3815B) . . . . . . 5-14
Emissions and Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Reducing Electro-magnetic Interference . . . . . . . . . . . . . 5-15
Regulatory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20
FCC Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20
Telephone Regulatory Notice . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Specifications and Regulatory
5-1
Introduction
Specifications and Regulatory
Intended Use/Indications for Use
Intended Use/Indications for Use
The Model 3810A is intended to be used upon prescription of a licensed
physician or authorized healthcare provider by patients as a means to
automatically collect and transmit medical information, such as weight,
blood pressure, and non-diagnostic ECG, over normal residential
telephone lines, between a patient, typically at home, and a healthcare
professional at the authorized provider.
Indications
for Use
The M3810A is indicated for patients at home, who are capable and
willing to self-administrate this device, upon prescription of their
healthcare provider, to collect and transmit medical information, such as
weight, blood pressure (including pulse rate) and non-diagnostic ECG
rhythm strip to the healthcare provider at another location. The patient
takes these measurements, typically once per day, and the information is
transmitted automatically via normal telephone time to the healthcare
provider. The device does not send any real-time alarms. Clinical
judgement and experiences are required to check and interpret the
information delivered.
Contraindications
The device is not intended as a substitute for medical care. The device is
contra indicated for patients with uncompensated heart failure, patients
at high risk of life threatening arrhythmias, patients with recent
myocardial infarctions, or patients requiring direct medical supervision
or emergency interventions.
5-2
Specifications and Regulatory
Specifications
Specifications
This section gives technical descriptions and specifications of the Philips
Telemonitoring Set devices, including physical, electrical, and
environmental.
Description
Home Hub
Model
M3812A
Type
Class II equipment, continuous operation
Display
LED panel
Ports
Serial Modem
TeleStation
Model
M3812B
Type
Class II equipment, continuous operation
Display
LCD panel
Ports
Serial Modem
Specifications and Regulatory
5-3
Specifications
Standard Scale
Model
M3813B
Type
- Type B applied part
- IPXO ordinary equipment
- Internally powered continuous operation
Display
- Digital, 2.0 in (51 mm) character height
- Weights displayed and announced simultaneously
Language
English or Spanish
Audio Volume
Voice readout of weight, prompts, and 4 settings
Measurement
Range
66 to 440lbs (30 to 200 kg)
Accuracy a
+ 0.5% of loading
at maximum patient weight + 2.2 lbs (1.0 kg)
Display Units
pounds (lbs) or kilograms (kg), user selectable
Maximum
Allowed Weight
440 lbs (200 kg)
Grab Bar and
Post
check for availability
a. Scale accuracy testing was performed on polyester carpet with a weight of 80 oz., t wist
of 4.8 x 3.3, and density of 4,000. A standard 8 lb. pad was used as
underlayment.
5-4
Specifications and Regulatory
Specifications
Steady Scale
Model
M3813A
Type
- Type B applied part
- IPXO ordinary equipment
- Internally powered continuous operation
Display
- Digital, 0.71 in (18 mm) character height
- Weights displayed and announced simultaneously
Language
English only
Audio Volume
Voice readout of weight, prompts, and 4 settings
Measurement
Range
66 to 365lbs (30 to 166 kg)
Accuracy
+ 1% of loading + 1.1 lbs (0.5 kg)
at maximum patient weight + 4.8 lbs (2.2 kg)
Display Units
pounds (lbs) or kilograms (kg), user selectable
Maximum
Allowed Weight
365 lbs (166 kg)
Grab Bar and
Post
Removable attachment
Specifications and Regulatory
5-5
Specifications
Blood Pressure Monitor
M3815A
Model
M3815A
Type
- Type B applied part
oscillometric
- IPXO ordinary equipment
- Internally powered continuous operation
Display
- Digital, 0.63 in (16 mm) character height
- Pressure and pulse displayed simultaneously
Measurement
Range
- Pressure: 20 to 280 mm Hg
- Pulse: 40 to 200 pulses per minute
Accuracy
Pressure transducer: + 2% or + 3 mm Hg
Pressurization
Automatic, using micropump
Depressurization Constant-air release-valve system
Deflation
Automatic exhaust
M3815B
Model
M3815B
Type
- Type B applied part
oscillometric
- Internally powered continuous operation
Display
- Digital, 0.79 in (20 mm) character height
- Pressure and pulse displayed simultaneously
Measurement
Range
- Pressure: 20 to 280 mm Hg
- Pulse: 40 to 200 pulses per minute
Accuracy
Pressure transducer: + 2% or + 3 mm Hg
Pressurization
Automatic, using micropump
Depressurization Constant-air release-valve system
Deflation
5-6
Specifications and Regulatory
Active exhaust valve
Specifications
Rhythm Strip Recorder
Model
M3816A
Type
- 1-channel lead
- Oscillometric, Type B applied part
- IPXO ordinary equipment
- Internally powered continuous operation
Display
LED light
Pulse Oximeter
M3814A
Model
M3814A
Type
- Type B applied part
- IPXO ordinary equipment
- internally powered continuous operation
(does not imply continuous monitoring
Display
- Digital 0.7 in. (1.8 cm) character height
- %SpO2 - Pulse displayed alternately
- %SpO2 display range: 0 - 100%
Measurement
Range
- %SpO2: 70 - 100% (functional hemoglobin)
- Pulse rate: 18 to 300 beats per minute
Measurement
Accuracy
- %SpO2: 70 - 100%, + 2 digits (+ 1 Standard
Deviation a statistical measure)
- %(SpO 2 calibration range: 70 - 100% determined
by arterial blood measurement on a Co-oximeter
Test methods available upon request.)
- Pulse rate: + 3%, + 1 digit
Measurement
Wavelengths
- 660 nanometers, 3 milliwatts (nominal)
- 910 nanometers, 3 milliwatts (nominal)
Biocompatibility Suitable for surface device, skin contact,
limited contact duration (up to 24 hours)
Specifications and Regulatory
5-7
Specifications
M3814B
Model
M3814B
Type
- Type BF applied part
- IPX1 ordinary equipment
- internally powered continuous operation
(does not imply continuous monitoring)
Display
- %SpO2 displayed in top window
0.75 inches character height
- Pulse rate displayed in bottom window
0.5 inches character height
Measurement
Range
- %SpO2: 70% to 100% (functional oxygen
saturation of arterial hemoglobin)
- Pulse: 30 to 250 beats per minute
Measurement
Accuracy
- %SpO2: 70% to 100%, + 3%
- Note: the %SpO2 calibration range of 70% to
100% was determined by arterial blood
measurement on a Co-oximeter. Test methods
available upon request.)
- Pulse rate: + 5 bpm
Measurement
Wavelengths
- 660 nanometers, 15 milliwatts (maximum)
- 910 nanometers, 15 milliwatts (maximum)
Biocompatibility Suitable for surface device, skin contact,
limited contact duration (up to 24 hours)
Note
5-8
Because pulse oximeter equipment measurements are statistically
distributed, only approximately 2/3 of pulse oximeter equipment
measurements can be expected to fall within the + Arms value measured
by a CO-oximeter. Functional testers, such as an SpO2 simulator, cannot
be used to assess the accuracy of pulse oximeter sensors.
Specifications and Regulatory
Specifications
Technical
Specifications
Physical
Product
Part #
Height
cm (in.)
Width
cm (in.)
Depth
cm (in.)
Weight
kg. (lbs.)
Home Hub
M3812A
3.8 (1.5)
20.0 (7.9)
27.9 (11.0)
0.93 (2.05) a
TeleStation
M3812B
12.7 (5.0)
21.8 (8.6)
15.9 (6.3)
0.77 (1.70) a
Standard Scale
M3813B
5.7 (2.3)
38.1 (15.0)
38.1 (15.0)
3.8 (8.4)b
Steady Scale
M3813A
5.1 (2.0)
48.8 (19.2)
48.8 (19.2)
6.8 (15)b
Blood Pressure Monitor
M3815A
6.9 (2.7)
16.5 (6.5)
11.2 (4.4)
0.57 (1.25) b
M3185B
6.2 (2.4)
16.3 (6.4)
11.2 (4.4)
0.35 (0.77)
Rhythm Strip Recorder
M3816A
6.9 (2.7)
16.5 (6.5)
11.2 (4.4)
0.34 (0.75) b
Pulse Oximeter
M3814A
6.9 (2.7)
16.5 (6.5)
11.2 (4.4)
037 (0.81) b
M3814B
6.2 (2.4)
16.3 (6.4)
11.2 (4.4)
0.35 (0.77)
Philips Device
a. Net weight, without power module
b. Net weight, with batteries
Electrical
Philips Device
Product
Part #
Power Source
Battery Life
9.0VAC/ 500mA
(Use Philips-supplied power
adapter only)
n/a
4 AA (1.5V) alkaline batteries
connected in series
for a total of 6 V
~ 12 months with
1 daily measurement
Home Hub
M3812A
TeleStation
M3812B
Standard Scale
M3813B
Steady Scale
M3813A
Blood Pressure Monitor
M3815A
M3815B
~ 3 months with
1 daily measurement
Rhythm Strip Recorder
M3816A
~ 12 months with
1 daily measurement
Pulse Oximeter
M3814A
M3814B
~ 6 months with
1 daily measurement
~ 6 months with
1 daily measurement
Specifications and Regulatory
5-9
Specifications
Environmental
Temperature
Philips Device
Product
Operating
Part #
Storage
TeleStation
10 - 40 oC
-9 - 54oC
M3812B (50 - 104 F) (15 - 130 F)
Standard Scale
M3813B
Steady Scale
M3813A
Blood Pressure
Monitor
M3815A
Rhythm Strip
Recorder
M3816A
Pulse Oximeter
M3814A
Home Hub
M3812A
Atmospheric
Pressure
Operating and
Storage
(hPa)
572-1013
Altitude
Relative
Humidity
(NonOperating and
condensing)
Storage
(hPa)
0-4600m
(0-15,000ft)
less than
85%
M3815B
M3814B
Warning
5-10
These devices are not suitable for use in the presence of a flammable
anesthetic mixture with air, oxygen or nitrous oxide. Oxygen
concentrations must be <25% and partial pressure <27.5 kPa when
no other oxidants are present.
Specifications and Regulatory
Electromagnetic Compatibility (except M3813B and M3815B)
Electromagnetic Compatibility (except M3813B and M3815B)
Note
The section applies to all Telemonitoring Set devices except the M3813B
Scale and M3815B Blood Pressure Monitor. See the following section for
Electromagnetic Compatibility information for these devices.
When using the Philips Telemonitoring System, electromagnetic
compatibility with surrounding devices should be assessed.
A medical device can either generate or receive electromagnetic
interference. Testing for electromagnetic compatibility (EMC) has been
performed according to international medical device standards EN
60601-1-2.
These EMC standards describe tests for both emitted and received
interference. Emission tests deal with interference generated by the
device itself, whereas Immunity tests deal with determining
electromagnetic compatibility of the device while used in the presence of
surrounding electronic equipment or other external sources that may
generate interference.
Warning
Radio frequency (RF) interference from nearby transmitting devices
may degrade performance of Philips Telemonitoring Set devices.
Electromagnetic compatibility with surrounding devices should be
assessed prior to using this equipment.
Philips Telemonitoring Set devices should not be used next to or
stacked with other equipment. If you must stack the device, check
that normal operation is possible.
Specifications and Regulatory
5-11
Electromagnetic Compatibility (except M3813B and M3815B)
Emissions
and
Immunity
The EMC standards state that manufacturers of patient-coupled
equipment must specify immunity levels for their devices when there is
reduced performance.
During the EN 61000-4-3 Radiated Immunity test, some reduced
performance was observed.
EN 61000-4-3 specifies that devices be subjected to a field of 3 Volts/
meter over a frequency range of 26 to 1000 MHz with no degradation of
performance or loss of function below the performance level specified
when equipment is operated as intended. Radio communication from the
Philips Telemonitoring Set devices may occasionally be interrupted
when subjected to frequencies in the 800 MHz - 942 MHz range at field
strength levels as low as 0.05 V/m. The phenomena discussed above are
not unique to this unit but are characteristic of radio instrumentation in
use today. The M3812A Home Hub and M3812B TeleStation are radio
receivers and their reception of Philips Telemonitoring Set device signals
can be degraded by electromagnetic interference.
Avoiding
Electromagnetic
Interference
The Philips Telemonitoring System is intended for use in an
electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Philips Telemonitoring
System can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications
equipment (transmitters) and the Philips Telemonitoring System as
recommended below, according to maximum output power of the
communications equipment.
The M3812A Home Hub and M3812B TeleStation contain a sensitive
radio receiver that is intended to receive radio signals from the
measurement devices and can be degraded by electromagnetic energy in
the frequency range of 870 MHz to 960 MHz. Avoid the use of any radio
frequency device operating in this frequency range when using the
Philips Telemonitoring System. Possible sources of interfering radio
frequency radiation are cellular telephones, cordless telephones, and
other products that contain radio transmitters. The following table gives
safe distances to keep radio frequency transmitters away from your
Philips Telemonitoring Set devices.
5-12
Specifications and Regulatory
Electromagnetic Compatibility (except M3813B and M3815B)
Recommended separation distances between
portable and mobile RF communications equipment and
Philips Telemonitoring Set devices except M3813B and M3815B
Rated maximum
output power of
transmitter (Watts)
0.01
0.1
10
100
Note
Recommended separation distance for
various transmitter frequencies
26 to 800 MHz
800 MHz to 2.5 GHz
feet.
meters
feet
meters
11.5
3.5
23
36
11
72
22
115
35
230
70
361
110
720
220
1150
350
2300
700
These guidelines may not always apply. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and
people.
Philips Telemonitoring Set devices have a Radio Test button that sends
a reduced strength test radio signal to the Home Hub or TeleStation,
which sounds an audio tone if the test signal is successfully received.
This test can be used to determine whether sources of interference are
present. These sources can be turned off or moved away to reduce their
strength and reduce interference. In addition, Philips Telemonitoring
Set devices and Home Hub or TeleStation can be placed closer to each
other so that the radio transmission from the Philips Telemonitoring Set
devices to the Home Hub or TeleStation has less distance to travel and
interfering radio signals have less effect. The radio transmission from
the Philips Telemonitoring Set devices is repeated periodically so that
an intermittent source of interference should only delay reception.
Avoiding Static Static discharges to Philips Telemonitoring Set devices may cause
Electrical temporary, unusual behavior. If a static discharge causes a temporary
Discharges malfunction, simply restart the measurement.
Specifications and Regulatory
5-13
Electromagnetic Compatibility (M3813B and M3815B)
Electromagnetic Compatibility (M3813B and M3815B)
The electromagnetic compatibility (EMC) validation of the M3813B
Scale and M3815B Blood Pressure Monitor included testing performed
according to the international standard for EMC for medical devices. See
the Manufacturer’s Declaration for details.
Electronic devices can either generate or receive electromagnetic
interference. The M3813B and M3815B have been evaluated for
electromagnetic compatibility (EMC) with the appropriate accessories
according to IEC 60601-1-2:2001, the international standard for EMC for
medical electrical equipment. This IEC standard has been adopted in the
European Union as the European Norm, EN 60601-1-2:2001.
Radio frequency (RF) interference from nearby transmitting devices can
degrade performance of the electronic equipment. Electromagnetic
compatibility with surrounding devices should be assessed prior to using
the equipment.
Fixed, portable, and mobile radio frequency communications equipment
can also affect the performance of electronic equipment. See your
Service Provider for assistance with the minimum recommended
separation distance between RF communications equipment and these
devices.
Warning
The use of accessories, transducers and cables other than those
specified in the Philips Telemonitoring system service and user
documentation can result in increased emissions or decreased
immunity of the system.
The products should not be used next to or stacked with other
equipment. If you must stack the product, you must check that
normal operation is possible in the necessary configuration before the
product is used.
5-14
Specifications and Regulatory
Electromagnetic Compatibility (M3813B and M3815B)
Emissions
and
Immunity
The M3813B and M3815B may be susceptible to interference from other
RF energy sources. Examples of other sources of RF interference are
other medical electrical devices, cellular products, information
technology equipment, and radio/television transmission. If interference
is encountered, as demonstrated by anomalous product behavior, attempt
to locate the source. Assess the following:
Reducing
Electromagnetic
Interference
•
Is the interference intermittent or constant?
•
Does the interference occur only in certain locations?
•
Does the interference occur only when in close proximity to certain
equipment?
Once the source is located, attempt to attenuate the interference by
distancing the product from the source as much as possible. If assistance
is needed, contact your local Service Provider.
Electromagnetic Emissions (M3813B and M3815B)
Emissions Test
Compliance
Electromagnetic Environment Guidance
RF emissions
CISPR 11
Group 1
The M3813B and M3815B use RF energy only for its
internal function. Therefore, its RF emissions are very low
and not likely to cause interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class B
Harmonic Emissions
IEC 61000-3-2
Not Applicable
The M3813B and M3815B are suitable for use in all
establishments, including domestic and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Voltage fluctuations / Not Applicable
flicker emissions
IEC 61000-3-3
Note
The M3813B and M3815B are intended for use in the electromagnetic
environment specified above. The customer or the user of these devices
should assure that it is used in such an environment.
Specifications and Regulatory
5-15
Electromagnetic Compatibility (M3813B and M3815B)
Electromagnetic Immunity (M3813B and M3815B) - General
Immunity Test
IEC 60601-1-2 Test Level
Compliance
Level
Electromagnetic
Environment Guidance
Floors should be wood,
concrete, or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should be at
least 30%.
Electrostatic
discharge (ESD)
IEC 61000-4-2
+ 6 kV contact
+ 8 kV air
+ 6 kV contact
+ 8 kV air
Electrical fast
transient/burst
IEC 61000-4-4
+ 2 kV for power supply lines
+1 kV for input/output lines
Not Applicable
Surge
IEC 61000-4-5
+ 1 kV differential mode + 2
kV common mode
Not Applicable
Voltage dips, short
interruptions, and
voltage variations
on power supply
input lines
IEC 61000-4-11
< 5% UT (> 95% dip in U T)
for 0.5 cycle
Not Applicable
40% U T (60% dip in U T)
for 5 cycles
70% U T (30% dip in U T)
for 25 cycles
< 5% UT (> 95% dip in U T)
for 5 sec.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Note: U T is the AC mains voltage prior to application of the test level.
5-16
Specifications and Regulatory
Electromagnetic Compatibility (M3813B and M3815B)
Electromagnetic Immunity (M3813B and M3815B)
Immunity
Test
IEC 60601Test
Level
Compliance
Level
Electromagnetic Environment
Guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
Not Applicable
Portable and mobile RF communications
equipment should be used no closer to any
part of the M3813B Scale and M3815B
Blood Pressure Monitor, including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended Separation Distance
d = 1.2 P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
80 MHz to 800 MHz d = 2.3 P
800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter’s specified
output power and d is the recommended
separation distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,a should be less than the compliance
level in each frequency range. b
Interference may occur in the vicinity of
equipment marked with the following
symbol :
Specifications and Regulatory
5-17
Electromagnetic Compatibility (M3813B and M3815B)
Electromagnetic Immunity (M3813B and M3815B)
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength at the
location in which the M3813B Scale or M3815B Blood Pressure Monitor are used exceeds the applicable
RF compliance level above, the device should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the
device.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
The M3813B Scale and M3815 Blood Pressure Monitor are intended for
use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of these devices can help prevent
electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment
(transmitters) and these devices as recommended below, according to the
maximum output power of the communications equipment.
Recommended separation distances between
portable and mobile RF communications equipment
and the M3813B Scale and M3815 Blood Pressure Monitor
Rated maximum
output power of
transmitter (Watts)
0.01
0.1
10
100
5-18
Specifications and Regulatory
Recommended separation distance for
various transmitter frequencies
150 to 800 MHz
800 MHz to 2.5 GHz
feet.
meters
feet
meters
0.32
0.1
0.66
0.2
1.3
0.4
2.3
0.7
3.9
1.2
7.5
2.3
13
23
7.0
39
12.0
75
23.0
Electromagnetic Compatibility (M3813B and M3815B)
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be determined
using the equation applicable to the frequency of the transmitter, where P
is the maximum output power rating of the transmitter in watts (W)
according to the transmitter’s manufacturer.
Note
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects and people.
Specifications and Regulatory
5-19
Regulatory Information
Regulatory Information
FCC
Regulations
This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to Part 15 of the FCC Rules. These limits
provide reasonable protection against harmful interference in a
residential installation. Philips Telemonitoring Set devices generate, use,
and can radiate radio frequency energy. If not installed and used
according to instructions, it may interfere with radio communications.
However, there is no guarantee that interference will not occur if the
equipment is properly installed.
If this equipment causes interference to radio or television reception,
which can be determined by turning the equipment off and on, the user is
encouraged to try to correct it by:
Notes
•
relocating the Home Hub or TeleStation,
•
increasing the separation between the Philips Telemonitoring Set
devices or the Home Hub or TeleStation and the device being
interfered with, for example, a TV,
•
consulting your healthcare provider.
Any changes or modifications to the equipment not expressly approved
by Philips could void the user’s authority to operate it.
The possibility of hazards arising from errors in the software and
hardware design are minimized by Philips’ use of a risk analysis and risk
management process as defined in Philips’ document CMS RISK
ANALYSIS PROCESS, document number A-Q2920-00126.
5-20
Specifications and Regulatory
Regulatory Information
Telephone
Regulatory
Notice
Your Philips Home Hub is registered with the Federal Communications
Commission (FCC) and is in compliance with part 68 of the FCC Rules
and Regulations. The FCC requires Philips to provide you with the
following information. The Home Hub contains a 14.4 Kbps modem.
You must, upon request, provide the following information to your local
telephone company (this information is also printed on the bottom of the
device): FCC Part 68 ID Number: 2M6USA-33569-DT-E and Ringer
Equivalence Number (REN): 0.3A.
Your Philips TeleStation complies with Part 68 of the FCC rules and the
requirements adopted by the Administrative Council for Terminal
Attachments (ACTA). ACTA requires Philips to provide you with the
following information. The TeleStation contains a 14.4 Kbps modem.
You must, upon request, provide this information to your local telephone
company.
On the bottom of the device is a label that contains, among other
information, a product identifier in the format
US: AAAEQ##TXXXXX.
For products approved after July 23, 2001, the digits in the product
identifier represented by ## are the REN without a decimal point (for
example, 03 is a REN of 0.3). If requested, this number must be provided
to the telephone company.
The REN is useful to determine the number of devices you can connect
to your telephone line and still have all of these devices ring when your
telephone number is called. In most (but not all) areas, the sum of the
RENs of all devices connected to one line should not exceed 5. To be
certain of the number of devices connected to your line as determined by
the REN, contact your local telephone company.
Note: (a) The Home Hub or TeleStation may not be used on coin service
phones provided by the telephone company. (b) Party lines are subject to
state tariffs and, therefore, you may not be able to use your own
telephone equipment if you are on a party line. Check with your local
telephone company. (c) Notice must be given to the telephone company
upon permanent disconnection of your telephone from your line.
Specifications and Regulatory
5-21
Regulatory Information
Rights of the Telephone Company: Should your Home Hub or
TeleStation cause trouble on your line that may harm the telephone
network, the telephone company shall, if possible, notify you that
temporary discontinuation of service may be required. If advance notice
is not practical, the telephone company may discontinue service
immediately, but temporarily. In such case of discontinuance, the
telephone company must (1) promptly notify you of such temporary
discontinuance, (2) afford you the opportunity to correct the situation,
and (3) inform you of your right to bring a complaint to the FCC
pursuant to the procedures in Subpart E of Part 68, FCC Rules and
Regulations.
The telephone company may make changes in its communications
facilities, equipment, operations, or procedures where such action is
required in the operation of its business and not consistent with FCC
Rules and Regulations. If these changes are expected to affect the use or
performance of your Home Hub or TeleStation, the telephone company
must give you adequate notice, in writing, to allow you to maintain
uninterrupted service.
A plug and jack used to connect the TeleStation must comply with
applicable FCC Part 68 rules and requirements adopted by the ACTA. A
compliant telephone cord with a modular plug is provided with the
TeleStation. It is designed to be connected to a compatible modular jack
that is also compliant. See installation instructions for details.
Consult your telephone company or qualified installer if you are using a
TeleStation and have specially wired alarm equipment connected to your
telephone line.
Contact Philips Medical Systems at (866) 246-7316 for repair or
warranty information.
5-22
Specifications and Regulatory
© Koninklijke Philips Electronics N. V.
Part Number M3810-90096, Issue 5
Printed in the U.S.A.
October 2008
*M3810-90096*

---

Source Exif Data:

File Type                       : PDF
File Type Extension             : pdf
MIME Type                       : application/pdf
PDF Version                     : 1.5
Linearized                      : No
Page Count                      : 112
Has XFA                         : No
XMP Toolkit                     : XMP toolkit 2.9.1-13, framework 1.6
About                           : uuid:1bb3f1b5-883b-47e6-9de3-3a87eaacb620
Creation Date--Text             : 29/10/2008 20:34:30
Producer                        : Amyuni PDF Converter
Version                         : Version 2.06 - Site Licence # C8E793E7-2458
Modify Date                     : 2008:11:20 14:42:10-05:00
Metadata Date                   : 2008:11:20 14:42:10-05:00
Document ID                     : uuid:c1d313e4-a638-11dd-98cc-0019e345e634
Format                          : application/pdf
Create Date                     : 29/10/2008 20:34:30

EXIF Metadata provided by EXIF.tools