DailyCare BioMedical ReadMyHeart 100 User manual

ReadMyHeart 100
Copyrights and Trademarks Notice
Copyright © 2006 DailyCare BioMedical, Inc. All rights reserved.
No part of this publication may be reproduced in any manner
whatsoever without written permission from the owner.
Proprietary rights of DailyCare BioMedical are involved with the
subject matter of this document and all manufacturing,
reproduction, use, and sales rights pertaining to such subject
matter are expressly reserved. The recipient, by accepting this
document, agrees that the information contained herein will not be
copied or reproduced in whole or in part, nor its contents revealed
in any manner or to any person, except to meet the purpose for
which this document was prepared and delivered without the
express permission of DailyCare BioMedical.
Printed in Taiwan.
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ReadMyHeart 100
Document Warranty
The information contained in this document is subject to change
without notice. DailyCare makes no warranty of any kind with
respect to this information. DailyCare SPECIFICALLY DISCLAIMS
ANY IMPLIED WARRANTY OF MERCHANTABILITY AND
FITNESS FOR ANY PARTICULAR PURPOSE.
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ReadMyHeart 100
Table of Contents
Copyrights and Trademarks Notice......................................... I
Document Warranty................................................................. II
Chapter 1: Introduction to ReadMyHeart............................... 1
Purpose of the device (Indications for use)............................1
Important safety notice...........................................................1
Caution...................................................................................2
Introduction: what do ECGs do?............................................3
How does ReadMyHeart work? .............................................3
Chapter 2: Getting started ...................................................... 4
Product Package contents .....................................................4
Product Back View & Side View.............................................5
Battery Installation...........................................................6
Top View..........................................................................6
LCD panel description.....................................................7
Turning the power on......................................................8
Turning the power off ......................................................8
Setting Date/Time ...........................................................9
Recording Heart Function (ECG) parameters........................9
Heart Function (ECG) parameters .......................................12
Chapter 3: Improving Recording Quality............................. 13
“Noise” appears during the recording time...........................13
Why should you wash your hands with soap?.....................13
Step by step recording procedures ......................................14
How do I know if there was a conductivity problem? ...........15
Alternative recording method ...............................................16
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ReadMyHeart 100
Chapter 4: Viewing records on ReadMyHeart ..................... 17
Recalling Data......................................................................17
Deleting data........................................................................18
Chapter 5: Installing ReadMyHeart software....................... 19
System requirements ...........................................................19
Software installation instructions..........................................19
Software registration and upgrade information....................20
Transferring data from ReadMyHeart to a PC......................21
Chapter 6: Using ReadMyHeart software............................. 24
Viewing Heart Parameters and Data Files...........................25
Viewing Heart Parameters Trend Graphic............................25
Deleting a Record ................................................................26
Printing Heart Function Trend ..............................................26
Chapter 7: Care and Maintenance........................................ 27
Cleaning the dry electrodes .................................................27
Product registration, updates, newsletters:..........................28
FDA and Health Canada Licence Numbers.........................28
Descriptions of the device....................................................28
Product Specifications..........................................................29
Medical Device Warranty .....................................................30
Limitations and Exclusions...................................................30
Chapter 8: User Assistance and Trouble Shooting.............32
Frequently Asked Questions ................................................32
“How to …?”, “What…?” and “ Where…?”...........................35
Contact DailyCare................................................................36
References...........................................................................36
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ReadMyHeart 100
Chapter 1: Introduction to ReadMyHeart
Thank you for purchasing ReadMyHeart.
This manual provides guidance on how to use this product, as well
as reference information on its components.
Purpose of the device (Indications for use)
ReadMyHeart is intended to record, display, store, recall, and
transfer electrical heart activity for home health care use. The
intended users are adults over the age of 20. This device is not
intended to substitute for a hospital diagnostic ECG
(ElectroCardiograph) device. This device is also not intended for
recording and transmission of user's ECG signals simultaneously.
Important safety notice
Cau e EC
idealize
tracing.
War adMy
an ECG
substitu
Warning:ReadMyHeart will NOT tell you if you have heart
blem
NOT int
tion:Th G graphic displayed on the LCD is an
d tracing, and NOT your recorded ECG
ning:Re Heart is NOT a diagnostic device, it is only
recorder and it CANNOT serve as a
te for a traditional ECG diagnosis.
pro s. Consult your physician for a diagnosis, do
erpret the numbers yourself.
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ReadMyHeart 100
Caution:
perate ReadMyHeart concurrently with other electrical
devices.
Do N
while
Do N
Do NOT mov e deeply while recording
Do N pad
Do N prior
Caut
reference range, multiple recordings are
Do NOT o
OT connect the device to your computer via USB cable
recording
OT record with a dirty or greasy hand surface
e, talk, or breath
OT press too hard on the dry conduction electrode
OT use creams, gels, moisturizers etc. on your hands
to using the device
ion:If your measurement values do NOT fall within the
recommended.
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ReadMyHeart 100
Introduction: what do ECGs do?
The function of our heart is so important. It has its own automatic
nervous (electrical) system to keep it running independently,
without control from the brain. Electrical waves travel through the
heart chambers to charge and trigger heartbeats. Each chamber
contracts with perfectly synchronized timing to circulate blood
effectively. If the chambers are not synchronized, the blood will not
circulate effectively, which can be the symptom or the cause of
cardiovascular diseases. For more information on irregular
heartbeats or arrhythmias, please visit the American Heart
Association’s website: www.americanheart.org
How does ReadMyHeart work?
The micro-current generated during heartbeats passes through
the thumbs, which is where the device records it. Like the
electronic cardiograph, it records the heart’s electrical activity and
counts the related cardiograph parameters for the users. These
measurements compose the ECG tracing (like the model picture
on the LCD screen) which doctors use to check for arrhythmias
and other cardiovascular diseases.
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ReadMyHeart 100
Chapter 2: Getting started
Product Package contents
;ReadMyHeart X 1
;USB Cable X 1
;ReadMyHeart Software CD X 1
;ReadMyHeart User’s Manual X 1
;External Auxiliary Electrode Cable X 1
Note: The following accessories are not included:
1. AAA alkaline batteries: Two batteries are needed to
operate ReadMyHeart.
2. Electrode gel pad: Pads for external auxiliary electrode
cable may be purchased at www.dailycareusa.com or your
local drug stores. Please check at your local drug store for
more information. Use only FDA cleared ECG electrode gel
pads.
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ReadMyHeart 100
Product Back View & Side View
Back View
Side View
+
Product Label
Battery cover
_
External Auxiliary
Electrode Socket
Sliding Socket
Cover
USB Cable
Socket
Product Label
Attention, consult
accompanying
document
Type BF
Equipment
Certified CE
marking, Notified
Body NO. 0197
Product Lot
Serial No.
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ReadMyHeart 100
Battery Installation
Slide the battery cover open, and insert two AAAalkaline batteries,
making sure the poles of the batteries are inserted correctly.
Note: If the batteries are inserted incorrectly, it may cause the
temperature of ReadMyHeart to rise suddenly. In the
event of a sudden rise in device temperature, immediately
remove the batteries and reinsert them correctly. Please
allow the device to drop to room temperature before
taking a new recording.
Top View
Front
Cover
Left Thumb
Electrode Right Thumb
Electrode
LCD Panel
Start/Off Button
M
Set Date/Time
File Transfer Button
Data Recall Button
6