MDMouse MD-100 User Manual

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
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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 CD­ROM 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
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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)
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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
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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
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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
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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
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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.
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