MDMouse MD-100 Setup guide

Model MD-100
Blood Pressure Monitor
Quick-Start
User Guide

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Thank you for choosing the innovative MDMouse® blood pressure monitor!
High blood pressure is a significant contributor to serious diseases such as heart
attack and stroke, but it is largely controllable with knowledge, lifestyle and
diet. Regularly monitoring will provide you and your physician with the
knowledge needed to decrease your risk of disease.
Use the MDMouse monitor as your normal computer mouse and you will
always have a handy blood pressure monitor right at your fingertips, making it
easy to quickly keep track of your blood pressure .
This manual will guide you through installation and how to take a blood
pressure measurement. You can find more information in the “Help” section of
the MDMouse application, and on our website at www.mdmouse.com.
Also, please register your new MDMouse monitor to receive any updates or
important information. You can do this on our website at
www.mdmouse.com/support.
Let’s get started…
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Requirements
Windows®-based Personal Computer with available USB port
CD-ROM drive to install software or internet connection to download software
Internet connection to email data or update online data records
Included in Package
1 MDMouse blood pressure monitor
1 Quick Start User Guide
1 CD-ROM with MDMouse application software
Safety and General Precautions
Intended Use
This device is intended for adults and for measuring blood pressure and pulse rate.
This device is not intended to be a diagnostic device. Self diagnosis and self treatment
are dangerous. Contact your physician if you observe values indicating hypertension.
Caution
People with severe blood flow problems or disorders should consult their physician
prior to using any blood pressure monitoring device as cuff inflation can cause damage
or internal bleeding.
Do not take measurements right after drinking alcohol, smoking, exercise, or eating as
those activities may distort the results.
Performance can be affected by a number of health factors including age, diabetes,
common arrhythmias, ventricular premature beats, atrial fibrillation, arterial sclerosis,
and pregnancy.
Care of your MDMouse
Do not inflate the inflatable cuff without a finger inserted inside the cuff.
Clean with a lightly-dampened cloth (don’t use chemical cleaners).
Do not bend or fold or use sharp objects which could damage the air bladder.
!
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Installing Your MDMouse® Blood Pressure Monitor
1 2 3
Install the Software
Insert the included disk
into your DVD/CD-ROM
drive
The installation program
will automatically start
If the install program
does not automatically
start, use Windows File
Manager, select the CD-
ROM drive, and double
click on “install.exe” file
Plug in Mouse
Plug the
MDMouse USB
cable into an
available port
on your
computer
Start Application
Double click on the
MDMouse
application icon on
your computer
desktop
Follow the on screen
instructions to set up
initial user
You’re set! Now let’s
take a blood
pressure
measurement…
MDMouse
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Taking a Blood Pressure Measurement
1 2 3
Flip Out Cuff
Lift the protective
cover open
Deploy the finger
cuff by pivoting it
outside the
mouse body
Close cover to
secure cuff in
place for
measurement
Insert Finger
Place your left
index finger inside
the cuff
Slide the cuff all
the way to the
base of your finger
Hold the mouse
with your left
hand with your
index finger
against the side of
the mouse as
shown
Tighten Cuff
User your right
hand to rotate
the rotating ring
surrounding the
cuff
Tighten the cuff
so it fits snugly on
your left index
finger
Flip
Pivot
Rotate
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Taking a Blood Pressure Measurement (con’t)
4 5 6
Hold at Heart Level
Lift the mouse up and
hold it to your chest
about the same level
as your heart
TIP: Hold the
MDMouse monitor in
approximately the
same position and
orientation each time
to help ensure
consistency
Click “Enter”
Hit “Enter” to
begin
measurement
The monitor will
automatically
inflate and
deflate the cuff
and take a blood
pressure reading
in approximately
30-45 seconds
Note: If you need
to halt a
measurement in
progress, hit
“Enter” to stop
Loosen and Close
When you are
finished taking a
measurement,
loosen the cuff by
rotating the ring
Flip the cover open
and store the cuff
back inside the
mouse
Close the cover
and use like a
normal mouse
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Enter

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Managing Your Blood Pressure Tracking and History
From the on-screen user interface, you can check your blood pressure
measurement history, set up alerts to remind you when it is time to take a
measurement, set up new users, and manage your data. Explore the
capabilities shown below, and you can also use the on-screen help guide to
provide you more information.
Manage
data storage
and
interfaces
View
history in
graph or
log form
Set up new
users, switch
users, and
set reminder
alerts
Get more
information
on functions
and features
Learn about
high blood
pressure
conditions
Check
software
status or
contact us
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Getting the Most From Your MDMouse
Here are some tips to help you get the most from your MDMouse monitor:
Get in the habit of checking your blood pressure frequently. Replace
your existing computer mouse with the MDMouse monitor so it is
always handy, and then use it periodically when you are using your
computer.
Set up reminder alerts to help you get in the habit of regularly
checking your blood pressure at consistent times of day.
It is important to not only check your blood pressure frequently but
also to look for trends and changes over time.
If you are seeing blood pressure test results that indicate any
hypertensive condition, let your physician know so they can work with
you on a plan to address this potentially serious condition.
Get everyone in your household (adults and teens) set up as different
users and have them regularly check their blood pressure. Since
hypertension is impacted by diet and lifestyle, viewing your family’s
data can give a better picture of the changes you may need to make,
and it also helps if everyone is working to that common goal.
Remember to loosen the cuff adjustment ring before removing your
finger after a measurement –this will help prevent damage to the
inflatable bladder.
There are many resources available to help understand and control
blood pressure and its associated health conditions. You will find
some helpful links on our website at www.mdmouse.com.
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Troubleshooting
If you are experiencing problems with the MDMouse monitor, please check
the following:
Problem Try This:
The inflatable finger cuff
does not inflate after
starting a measurement
1) Stop and restart the MDMouse application and try again.
2) Disconnect the MDMouse USB cable and reconnect.
The inflatable cuff doesn't
deflate after a
measurement
1) Stop and restart the MDMouse application and try again.
2) Disconnect the MDMouse USB cable and reconnect.
Measurements seem
erratic or vary significantly
from measurement to
measurement.
It is common to see some variation
since blood pressure changes
throughout the
day, and from day to day. Take several
measurements over a 10
-15 minute period to see if they are
consistent. If
not:
1) Ensure the finger cuff is positioned all the way down the base
of your left index finger
2) Make sure the cuff is snugly tightened on your left index finger
every time you take a measurement
3) Hold the monitor near heart level in the same position each
time you take a measurement
4) Keep your finger during a measurement; slight movements can
affect the measurement accuracy.
5) Stay still and don't talk while measuring BP
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Error Messages
You may encounter one of the following error messages . If so, please see the
following description and follow the onscreen directions:
Error Message Description
Malfunction
- Please
Measure Again
A problem occurred when during operation. If the problem
persists, try disconnecting and reconnecting the MDMouse and try
again.
Communication Error
-
Reconnect MDMouse
A data communication error between the MDMouse and your PC
has occurred. Disconnect the USB cable and reconnect
Inlfation Malfunction
-
Please Measure Again
A problem occurred when inflating the finger cuff. Readjust the
cuff and try measuring again. Keep your finger still
since
movement
can affect measurements
Deflation Malfunction
-
Please Measure Again
A problem occurred while deflating the finger cuff. Readjust the
cuff and try measuring again. Keep your finger still
since even
slight movements can affect measurements
Finger Ring Too Loose
-
Readjust and Measure
Again
Readjust the finger cuff and measure again. Make sure the cuff is
snugly tightened at the base of the left index finger
Finger Ring Too Tight
-
Readjust and Measure
Again
Readjust the finger cuff and measure again. The cuff should feel
snug on the finger, but not so tight it is restricting blood flow
Data Invalid
- Please
Measure Again
The collected data appeared to have
a problem. The most
common cause is movement of the finger during measurement.
Readjust the finger cuff and measure again.
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Specifications
* Up to available PC hard drive capacity
Measurement Method
Oscillometric with proprietary algorithm processing
Measurement Range
Pressure 55
-200 mmHg
Pulse 40
-200 beats per minute
Accuracy
Pressure
± 3 mmHg
Pulse
± 5% of reading value
Measurement Resolution
1 mmHg
Cuff Inflation and Deflation
Automatic
Number of Users
Unlimited*
Number of Measurements
Stored
Unlimited*
Cuff Configuration
Use with Left
Index Finger
Finger Circumference
1.5
-3.5 inches Circumference (3.7-8.8cm)
Power Source
USB DC 5V 500mA
USB Cable
5 feet (145cm)
Operating System
Compatibility
Microsoft Windows® 98, Windows 2000, Windows ME,
Windows NT, Windows XP, VISTA 32/64, Windows 7,
Windows 8
Operating
Conditions
50
to 104° F (10 to 40° C), 15 to 90% relative humidity,
atmospheric pressure 86kPa
-106kPa, altitude 2000m
Storage and Transport
Conditions
-
13 to 158° F (-25 to 70° C), 10
to 95% relative humidity,
atmospheric pressure 86kPa
-106kPa, altitude 2000m
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Warranty
The MDMouse blood pressure monitor is guaranteed for 1 year from date of
purchase. This warranty does not apply to damage caused by accidents,
improper handling, improper use, or modifications made by any party other
than CalHealth, Inc. or its authorized representatives.
Please see our website at www.mdmouse.com for further information and
instructions for warranty claims.
Disposal
This marking indicates that this product should not be disposed with
other household wastes throughout the EU. To prevent possible harm
to the environment or human health from uncontrolled waste disposal,
recycle it responsibly to promote the sustainable reuse of material resources.
To return your used device, please use the return and collection systems or
contact the retailer where the product was purchased. They can take this
product for environmentally safe recycling.
About Us
The MDMouse monitor was developed by CalHealth, Inc. in California and
manufactured in China.
CalHealth, Inc. Ya Horng Electronic Co., LTD.
10620 Treena Street Suite 230 No. 35, Shalun, Anding District., Tainan, Taiwan
San Diego, CA 92131 Factory: Atten Electronic (Dongguan) Co., Ltd.
www.mdmouse.com
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FCC Statement
POTENTIAL FOR RADIO/TELEVISION INTERFERENCE (for USA only)
This product 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 are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause
harmful 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 the
interference by one or more of the following measures:
•Reorient or relocate the receiving antenna.
•Increase the separation between the equipment and receiver.
•Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
•Consult the dealer or an experienced radio/TV technician for help.
You are cautioned that changes or modifications not expressly approved by the party
responsible for compliance could void the user’s authority to operate the
equipment.
Certifications
0434
Type BF Applied part (cuff)
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Reference to Standards
This device complies with the following normative documents:
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices as amended by
Directive 2007/47/EC
•EN ISO 13485:2003 /AC: 2009:Medical devices - Quality management systems –Requirements
for regulatory purposes (ISO 13485:2003) Reference to standards contd.
•EN ISO14971:2012: Medical devices - Application of risk management to medical devices (ISO
14971:2007, Corrected version 2007-10-01)
•IEC60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007); EN 60601-1:2006+AC (2010) : Medical
electrical equipment - Part 1:General requirements for basic safety and essential Performance
•EN1060-3:1997+A1:2005+A2:2009: Non-invasive sphygmomanometers, Part 3: Supplementary
requirements for electromechanical blood pressure measuring systems
•EN1060-4: 2004 Non-invasive sphygmomanometers. Test procedures to determine the overall
system accuracy of automated non-invasive sphygmomanometers.
•IEC/EN 60601-1-11 : General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment
•IEC 80601-2-30: 2009 (First Edition) for use in conjunction with IEC 60601-1:2005
•EN 80601-2-30: 2010/ ANSI/AAMI 80601-2-30: 2009 : Particular requirements for the basic
safety and essential performance of automated non-invasive sphygmomanometers
•EN60601-1-2: 2007 /AC 2010: Medical electrical equipment: Part 1‐2: General requirements for
basic safety and essential performance-collateral standard electromagnetic compatibility
•EN 55011Group 1 Class B: 2009+A1:2010 : Industrial, scientific and medical equipment - Radio-
frequency disturbance characteristics - Limits and methods of measurement
•FCC 47CFR PART 15B AND ANSI C63.4 (2003)
•EN ISO 10993-1:2009 Biological evaluation of medical devices-Part 1: Evaluation and testing
within a risk management process (ISO 10993-1:2009)
•ANSI/AAMI SP10: 2002/A1 2003(R) 2008: Manual, electronic or automated
sphygmomanometers
•ANSI/AAMI/ISO 81060-1:2007,ANSI/AAMI/IEC 80601-2-30:2009, ANSI/AAMI/ISO 81060‐2:2009
Non‐invasive sphygmomanometers Part 2: Clinical validation of automated measurement type
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MDMouse® is a registered trademark of CalHealth, Inc.
Windows® is a registered trademark of Microsoft, Inc.
© 2013 CalHealth, Inc. All rights reserved.