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
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LCD panel description
(See p. 9 ‘Recording ECG Parameters’ to obtain the screen below)
1
2
3
4
5
6
8
9

7
# Item LCD Panel Descriptions
1Search Displayed when detecting heart electrical signals.
2
Flashes when recording is in progress. Flashing stops
when recording is completed. NOTE: This is an
idealized ECG tracing, NOT a real-time recorded
ECG tracing. It does not represent your actual ECG.
3Displayed when in data record mode.
4Displayed when transferring data.
5Record #
It is the total # of records stored or the number of the
records being displayed in data recall mode.
A blinking record # indicates that the memory is
(almost) full;
Note: If this number reaches 30, you cannot take any
more measurements until you delete the stored
records or transfer them to a PC (see page 18/21).
6Battery
Condition indicates the battery power is normal.
indicates the battery power is low.
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7
is displayed when signal recorded is noisy or
beyond the device’s testing range.
Note: Inaccurate parameters will still be displayed on
LCD and stored. They will appear in RED on your
heart trend when displayed on the software (See Ch.
6 on Software Features)
8HR or
Noise Level
During the recording, the number represents
•the “noise” level in the electrodes, indicating
insufficient conductivity (if it changes abruptly) or
•the instant heart rate reading
When the recording is complete, it displays the
average Heart Rate of the measurement. Number
flashes when signal recorded is >100, or <60.
Note: If noise is present during recording then the HR
shown is not accurate.
9
ST, QRS
Not displayed at the time of recording.
When the recording is complete, displays the key
parameters recorded by the device. Numbers flash
when signal recorded is outside reference range.
Date/Time Month/Day/Hour/Minute
Turning the power on
Press any button once to turn the power on.
The main menu will show items 1through 6on the LCD display.
Turning the power off
Hold the button for 3 seconds to turn off the device.
The device also has an auto-off design that will automatically
switch the device off if it is left idle for more than 2 minutes.
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Setting Date/Time
When the device is showing the main menu:
1. Use a thin pointed object (like a toothpick) to click the
indented button. Do NOT use a sharp object as this could
damage the device. The number under Month on the LCD
panel will start to flash. See step 3 below to change value.
2. Press again to go to the Day. Press button to go to Hour.
Press button again to go to Min (Minutes).
3. Press the button when the numbers are flashing to change
to your desired value.
4. Press button to go back to the main menu.
Recording Heart Function (ECG) parameters
1. Wash your hands with soap and water then towel dry before
using the device. DO NOT use a hand dryer. DO NOT use
creams or moisturizers.
2. Sit on a chair, your back straight, feet on the ground, with your
shoulders relaxed.
3. Relax and breathe calmly.
4. Hold the device in your hand and rest it on your lap.
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ReadMyHeart 100
5. Press the button to start recording.
6. Immediately place your thumbs gently on the dry electrode
pads and make sure that they cover the whole electrode pad.
7. will animate on the LCD panel during the recording.
8. The device will record for around 25 -27 seconds. Do not move,
talk, or breathe deeply during recording time.
9. If “Noise” appears on the LCD screen and the HR value varies
rapidly from time to time, the conductivity of the dry electrodes
is insufficient for a recording. See Chapter 3 for instructions on
improving the accuracy of the measurements.
Note:
1. You cannot stop a recording that is already in progress. Please
let the device run the full 25 -27 seconds before starting a new
recording.
2. Data will be saved automatically after each recording. The
device can store up to 30 records.
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When it is done if the conductivity is very poor, then the LCD panel
will look like this:
If the measurement is completed despite disturbed conductivity,
the screen will look like this:
Note:
In the screen above, even though the numbers are displayed, the
measurements are inaccurate. Please take a new measurement
as described from Step 1. Note that the “Noise” measurements
will appear in red when displayed by the software (see Ch. 6 on
software features).
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ReadMyHeart 100
Heart Function (ECG) parameters
The ReadMyHeart hardware displays 3 heart function (ECG)
parameters: the average heart rate (HR), the ST segment (ST),
and the QRS interval (QRS), displayed on the LCD after each
recording. The reference range of the parameters is shown below.
If the recorded value falls out of the range, the recorded numbers
will flash.
Parameters Reference Range Warning when out of
range/inaccurate
HR 60 < HR＜100 bpm
ST -2 < ST＜+2 mm
QRS 0.08 < QRS＜0.12 sec
Flashing numbers
Attention: The information above is for reference ONLY. Do NOT
interpret the numbers without consulting a physician. If the measured
parameters frequently and/or consistently fall outside the reference
range, consult your physician immediately. Regardless of whether
the numbers fall within or outside the reference range, see your
physician if you experience any abnormal symptoms (e.g acute
chest pain, palpitations, dizziness…). Recorded data by
ReadMyHeart may be provided to a physician for reference.
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ReadMyHeart 100
Chapter 3: Improving Recording Quality
“Noise” appears during the recording time
If the conductivity is too poor for an accurate reading, the following
may apply:
•“Noise” appears on the LCD
•HR numbers change rapidly/ abruptly during recording
•You may feel that the heart rate measured (after recording
is complete), is higher than what you have perceived.
The conductivity between your thumbs and the dry electrodes may
be too poor because:
•Thumbs are greasy or too dry.
•Contact pressure between the thumbs and the dry
electrodes may be too strong.
If this is the case, please review the next section to improve
conductivity.
Why should you wash your hands with soap?
The conductivity between your thumbs and the dry electrodes is
crucial for the device to clearly detect the micro-current generated
during the heartbeats. Common factors can affect the conductivity
and therefore, the accuracy of the measurement:
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ReadMyHeart 100
•your thumbs may be covered by dirt, oil, or layers of residue
•the skin of your thumbs may be too dry
•the skin on your thumbs may be very thick
By washing your hands with soap, you will not only remove any
dirt or oil but also moisturize the surface, improving the
conductivity of your thumbs. The micro-current generated during a
heartbeat is then able to properly travel through your thumbs and
be recorded by the dry electrode.
Step by step recording procedures
To improve the accuracy of a recording you need to adhere to the
following procedures:
1. Wash your hands with soap and water then towel dry before
using the device. Fingers need to be slightly moist. DO NOT
use cream or moisturizers. DO NOT use an electric hand dryer.
2. Sit on a chair, your back straight, feet on the ground, your
shoulders relaxed.
3. Relax and breathe calmly.
4. Hold the device in your hand and rest it on your lap.
5. Open the cover and press the button to start recording.
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ReadMyHeart 100
6. Place your thumbs gently on the dry electrode pads and make
sure that they cover the whole electrode pad.
7. Do not move, talk, or breathe deeply during the 25 -27 second
period of recording.
How do I know if there was a conductivity problem?
1. If you see the Noise/Heart Rate vary quickly (e.g, going above
200) during the recording, then the conductivity is too poor. To
improve the conductivity and accuracy, adjust the amount of
pressure your thumbs exert onto the dry electrode (not too
hard). Make sure you have washed your hands and followed
the procedures. It may take a few practice recordings to
stabilize the noise/heart rate readout and take an accurate
recording.
2. If you cannot hold the device steadily, do NOT have clean
hands, have thick skin on your hands, or have persistent
trouble recording through your thumbs, you may need to use
an external electrode (see next section).
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ReadMyHeart 100
Alternative recording method
The device can take measurements through an external auxiliary
electrode cable. This cable and ECG conductive adhesive
electrodes (ECG pads) are included, but replacement of ECG
pads are optional accessories, available for purchase separately.
Note: Use only FDA approved ECG pads.
To record using external electrodes, please follow this procedure
(as seen on the QuickGuide):
1. Auxiliary electrode Socket is located on the left of the
device (see page 18). Slide the socket cover to expose the
external electrode socket on the device.
2. Connect the external auxiliary electrode cable to the device.
3. Place the sticky electrode pads on the middle of the inner
forearms, RED electrode on the right arm and BLUE electrode
on the left.
4. Press the button to start recording.
5. Don’t move, talk, or breathe deeply during the 25 -27 second
period of recording. Do not touch the dry electrodes.
16