MDMouse MD-100 User Manual

(ClickBP version)
Systolic
MD-100
Blood Pressure Monitor
User
Manual
MDMouse User Manual Model MD-100
Intended Use
The MDMouse blood pressure monitor is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult indi­vidual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the left index finger. The cuff circumference is designed to fit adult Left In­dex Fingers from 1.5 to 3.5 inches (3.7-8.8 cm) in circumference.
!
Caution
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.
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.
This unit will not serve as a cure for any symptoms of your heart or disease. The meas­urement result is only for reference. Always consult your physician if any measuring re­sults are to be interpreted.
Always follow the operation procedures described in this manual to measure your blood pressure correctly.
Do not use the MDMouse to measure blood pressure on infants or children (it is OK to use as a normal computer mouse).
Do not use the unit on infants or persons who cannot express one's intention.
Do not inflate the cuff without being wrapped on an index finger.
Do not drop the MDMouse.
Safeguard the unit from strong impact.
Measurement may be inaccurate if the device is used close to a television, microwave oven, mobile phone, X-ray or other devices with strong electrical field.
Do not attempt to service the unit yourself – please refer to an authorized repair facility if your MDMouse system needs repair.
Be sure to store this manual for future reference.
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MDMouse User Manual Model MD-100
Requirements
Your MDMouse monitor requires the following to use:
Windows®-based Personal Computer with available USB port
Internet connection to download installation software
Internet connection to update newest application software or email data online
Included in Package
1 MDMouse blood pressure monitor
1 Quick Start User Guide
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MDMouse User Manual Model MD-100
A Great Step to a Healthier Life
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, and working with your physician. Regular 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 track of your blood pressure – a great step towards staying healthy!
The following instructions will guide you through installation and how to take a blood pressure measurement, set user profiles, review your history, and transfer your data history to your phy­sician. You can also find more information in the “Help” section of the MDMouse application, or learn more on our website at www.mdmouse.com.
Also, please register your new MDMouse monitor to receive any updates or future information. You can do this on our website at www.mdmouse.com/support.
Disclaimer
Information in this guide may change without notice. The manufacturer assumes no responsi­bilities for errors that may appear in this guide.
Copyright © 2013 CalHealth, Inc. All rights reserved. No part of this publication may be repro­duced, photocopied, stored in a retrieval system, or transmitted without prior written consent of CalHealth, Inc.
MDMouse® is a registered trademark of CalHealth, Inc.
Windows® is a registered trademark of Microsoft Corporation
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MDMouse User Manual Model MD-100
Table of Contents
Understanding Blood Pressure............................................................................................... 7
What is blood pressure?............................................................................................................................7
What constitutes a high blood pressure?................................................................................................7
How can I tell how high my blood pressure is?.........................................................................................7
Changes in Blood Pressure........................................................................................................................7
Installing the Software and Mouse......................................................................................... 8
Making a Blood Pressure Measurement.............................................................................. 11
Start the MDMouse-ClickBP Application…..............................................................................................11
Taking a Blood Pressure Measurement..................................................................................................12
Exploring the MDMouse Capabilities................................................................................... 14
About the Application Screen................................................................................................................14
User Account Management................................................................................................. 15
Switching to a Different User Account....................................................................................................15
Creating other User’s Account................................................................................................................15
Removing other User’s Account .............................................................................................................15
User Profiles (Options)........................................................................................................ 16
Selecting a Display Language..................................................................................................................16
Selecting Chart Color ..............................................................................................................................16
Creating an ‘Email to’ Address……...........................................................................................................16
Recalling Other User’s Password……........................................................................................................16
Updating Existing Application Software..................................................................................................16
Starting, Stopping and Displaying a Measurement............................................................... 17
Starting a Measurement.........................................................................................................................17
Stopping a Measurement….....................................................................................................................17
Displaying a Measurement .....................................................................................................................17
Displaying Trend Curve of Blood Pressure……………............................................................... 18
Managing Measurement Records…....................................................................................... 19
Creating Measurements Excel File…………………………………………………………………………………….………………..19
Sending Measurements Using Email ......................................................................................................19
Printing Measurements…………………….....................................................................................................19
Deleting Measurements .........................................................................................................................19
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MDMouse User Manual Model MD-100
Reviewing or Deleting History Data Log................................................................................................ 20
Reviewing Result and Displaying Pulse Waveform, WHO BP Level Illustration .............. ...................... 20
Deleting Logs ..........................................................................................................................................20
................
Uninstalling the MDMouse Application................................................................................ 21
Care of Your MDMouse Monitor.......................................................................................... 22
Troubleshooting................................................................................................................... 23
Error Messages.................................................................................................................... 24
Product Specification............................................................................................................ 25
Software and Product Update............................................................................................... 26
About Us .............................................................................................................................. 26
Warranty............................................................................................................................. 27
Reference to Standards ........................................................................................................ 29
FCC Statement.................................................................................................................... 30
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MDMouse User Manual Model MD-100
Understanding Blood Pressure
What is blood pressure?
The heart creates a force as it pushes blood into the arteries and through the blood circulation system. The arteries create another force as they resist the blood flow. Blood pressure is the result of these two forces. The more blood your heart pumps and the narrower your arteries, the higher your blood pressure.
Blood pressure is expressed by two numbers which show your “Systolic” pressure (the higher number, when the heart is pumping out blood) and “Diastolic” pressure (the lower number, when the heart is at rest between beats).
What constitutes a high blood pressure?
According to the Joint National Committee 7 (JNC 7) definitions, when systolic blood pressure exceeds 140 mmHg or diastolic blood pressure exceeds 90 mmHg, this constitutes high blood pressure (see figure below).
How can I tell how high my blood pressure is?
The MDMouse application displays measurement results (including systolic blood pressure, di­astolic blood pressure, and pulse) based on the Joint National Committee 7 (JNC 7) classification of blood pressure levels. The color-coded displays provide a convenient way of gauging the condition of your blood pressure.
It is recommended that you consult a physician to fully understand blood pressure levels.
Changes in Blood Pressure
A person's blood pressure is constantly changing. Blood pressure can fluctuate considerably through the course of a single day, and it is also affected by the seasons and by the weather. One or two readings are not sufficient to get an accurate picture of your blood pressure. Ideally, you should get into the habit of checking your blood pressure at fixed time several times a day, every day, and keep a detailed record of these readings. This record can then be e-mailed or faxed to your doctor, helping you to monitor your health on an ongoing basis.
A normal, healthy person's blood pressure fluctuates within a range of approximately ±10 mmHg.
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MDMouse User Manual Model MD-100
Installing the Software and Mouse
Follow the steps below to install the MDMouse-ClickBP installation software
1. Visit our web site at www.mdmouse.com , click Support
and Select Software or click Software Updates
2. Choose ClickBP2016 Blood Pressure Monitor Installation Software and click Download Now
3. If pop-up “Windows protected your PC”,
press More info
click Run anyway
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MDMouse User Manual Model MD-100
4. A “Confirm Installation screen” displays prompting you to install the software. Click Next to continue.
5. If prompted to install the device driver,
click Install to continue.
6. After the MDMouse application is installed
successfully, a pop-up window displays “Installation Complete”, Click Close.
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MDMouse User Manual Model MD-100
7. After the installation is complete,
click Close to close the window.
8. Hook up the MDMouse by connecting the USB connector to an available USB port on your computer.
You’re done! Now let’s take a blood pressure measurement.
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Making a Blood Pressure Measurement
Start the MDMouse-ClickBP Application
1. To log into the MDMouse-ClickBP application,
click the “ClickBP icon” on your desktop.
2. For your first login attempt, you can use the “Welcome screen” to enter a user name to create a new account, then click Confirm to log in.
Tip: Password is optional, it means that you can change (setup) password later on when you really need it.
Tip: If you have forgotten your account password, you can also use the “Login screen” to create a different user name to login or send email to CalHealth Inc. Customer service: support@mdmouse.com
3. There is a pop-up tutorial. It is recommended
that you complete the tutorial before using your MDMouse.
Note: Once you have taken a measurement, the tutorial will not pop automatically, and only click Help to show it again.
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MDMouse User Manual Model MD-100
Taking a Blood Pressure Measurement
Follow the instructions below to take a blood pressure measurement.
1 a. Make sure connect your MDMouse to a USB port on your computer.
b. Before taking a reading, you should sit quietly for around 5 minutes, and there should be an interval of at least 1 minutes between readings. While taking a measurement you should stay calm and relaxed, and try not to talk. This will improve the accuracy of the readings.
2. Lift the protective cover from the mouse and flip the finger cuff out. Flip the protective cover back closed.
3 a. Slide your left index finger all the way into the cuff so that the cuff is on the lowest part of your finger.
b. Hold your finger against the MDMouse so that the inside of your finger is laying along the side of the MDMouse. c. Tighten the finger ring for the suitable finger size position. It should feel
snug on your finger, but not so tight that it restricts blood flow.
4 a. Locate the bottom of your sternum, this is the level you’ll want to
hold the MDMouse while taking a measurement. This places the
MDMouse at the same level as your heart, helping improve the
consistency and accuracy of the measurement.
b. Place the MDMouse at your sternum and press the “Enter” key on the
keyboard or click the “Start” button in the “application screen” to begin a
measurement.
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MDMouse User Manual Model MD-100
5. During the measurement process, you will hear the inflation pump in the MDMouse activate and will feel the cuff pressure on your finger. A typical measurement takes approximately 25-40 seconds. If at any time during this process you need to stop the measurement,
press the “Enter” key on the keyboard or click the “Stop” button in the “application screen” and the cuff will deflate.
6. After you have finished measuring, loosen the finger cuff by with the
rotating finger ring and pull out your index finger.
7. Rotate the cuff back inside the MDMous into its original position and close the protective cover.
Note: If your finger feels cold, please warm it up before measuring your blood pressure as cold temperature can affect accuracy. Please make sure the room temperature will not be below 50 degree Fahrenheit or 10 degree centigrade.
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About
MDMouse User Manual Model MD-100
Exploring the MDMouse Capabilities
Although it is simple and quick to begin using the MDMouse blood pressure monitor, there are other features and capabilities you may wish to use.
the Application Screen
The MDMouse-ClickBP “application screen” consists of the following elements:
Navigation Panel—Use to navigate to a configuration screen, Log or Trend All, Morning, Daytime, Evening or Record and Help
Display Area—This area displays BP readings, logs, active process diagram and pulse waveform and WHO blood pressure level illustration
Start—Click “Start” or “Enter key” when you are ready to start your BP measurement
Status Panel—This panel displays the current user account and some operation messages
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User Account Management
This section shows you how to create or delete other’s user account and configure a user profile. If more than one person is going to use the MDMouse monitor to measure their blood pressure, each user should set up their own account.
Note: If multiple people use the same user account, the measurement history will
consist of data from the different users, making this data chaos.
Switching to a Different User Account
You can switch to another user account from the “Login screen” and select the user account
Login screen
you want to use and click Login to log in.
Creating other User’s Account
You can use the “Add New User screen” to create a new user account. When you start the MDMouse-ClickBP application,
Add New User screen
the “Login screen”displays, you can click Add New User, then simply enter a new user name and click Confirm to create and log in. (* password is optional)
Removing other User’s Account
You can use the “Options screen” (click Options from “Login screen”), the “Options screen
displays, then select the user name you want to remove/delete. A warning screen displays prompting you to confirm the deletion. Once you delete an account, all related data is also removed.
Options screen
Notice: The first user who logged into the MDMouse-ClickBP application will be administrator by default and only administrator can delete other’s user account.
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MDMouse User Manual Model MD-100
User Profiles (Options)
You can use the “Options screen” (click Options from the ”Login screen”) to configure the following settings:
Selecting a Display Language
Selecting Chart color of active process diagram and pulse waveform and trend curve
Creating an ‘Email to’ Address for the person who takes care of your health
Recall Other User’s Password
Update Existing Application Software
Selecting a Display Language
You can select your own language instead of the using the default (English). Start the MDMouse-ClickBP application, click Options from the “Login screen”, the “Options screen” displays, then select your language from the list. The MDMouse-ClickBP application restarts automatically and displays in your selected language.
Selecting Chart Color
You can use the “Options screen” to select the background color to display the charts, such as active process diagram, Pulse waveform and trend curve of blood pressure, select darker color or lighter color (Note: darker color by default).
Creating an ‘Email to’ Address
You can use the “Options screen” to input an ‘email to’ address for the person who takes care of your health.
Recalling Other User’s Password
If user have forgotten password, you can use the “Options screen” to recall other user’s password.
Notice: only administrator (the first user who logged into the application) can recall other user’s password
Updating Existing Application Software
In the middle of of the “Options screen”, you can check the difference between Current version and New version, If Current & New version were the same, you are usingthe newest software version.
If Current & New version were different, you can click Update to update the software automatically.
Please check periodically for any newest application software and update it.
Notice: The first user who logged into the MDMouse-ClickBP application will be administrator by default, and only administrator can update application software.
Notice: The first user who logged into the MDMouse-ClickBP application will be administrator by default and only administrator can delete other’s user account.
Note: the software available at Wi-Fi network is connected.
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MDMouse User Manual Model MD-100
Starting, Stopping and Displaying a Measurement
After you have logged into the MDMouse-ClickBP application
Application screen
Starting a Measurement
1. Applied the finger cuff and adjusted it.
2. Press the “Enter” key on the keyboard or click the “Start” button in the application screen, the cuff begins to inflate and deflate, the cuff pressure is indicated in mmHg-meter (left top of the creen).
3. You should see the animation (section and entire active process) on the right portion of the screen
and after the cuff reaches the maximum, the pump stops and the cuff begin to deflate.
4. The system starts to take your measurement and
it may take approximately 30-45 seconds.
Stopping a Measurement
You can stop the measure at any time by pressing the “Enter” key on the keyboard or click the “Stop” button
in the application screen. The cuff automatically deflate and system stop the operation.
Displaying a Measurement
5. The result of the measurement displays on the top of
the screen and result shown are color-coded based on the WHO/ISH classification.
6. You should hear the voice of narrator to announce
measurement result (if the voice function is applied).
7. The Pulse waveform and WHO blood pressure level
illustration display on the right portion of the screen.
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MDMouse User Manual Model MD-100
Displaying Trend Curve of Blood Pressure
To display the trend curve of blood pressure, click Trend All, Morning, Daytime or Evening from navigation panel, the “Trend Curve diagram” displays on the screen.
Tip: To enlarge Trend Curve diagram, directly click ”Trend Curve diagram or click <F5> key on your keyboard.
Tip: To restore Trend Curve diagram, directly click ”Trend Curve diagram” again or click <F5> key on your keyboard.
Note: Trend All 00:00 – 24:00 Morning 00:00 – 10:00 Daytime 10:00 – 18:00 Evening 18:00 – 24:00
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person
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MDMouse User Manual Model MD-100
Managing Measurement Records
To manage blood pressure measurement records stored on your computer, click Record from navigation panel, the “Record screen” displays listing the measurements date and no. of logs by date. Follow the steps below can Excel, Email, Print and Delete selected blood pressure measurements
Record screen
Creating Measurements Excel File
1. You can use the “Record screen” (click Record to display “Record screen’).
2. Select measurement date(s) from date list you want to create excel file.
3. Click Excel. A new Microsoft Excel file displays with the selected measurements.
4. An Excel file yyyy-mm-dd hhmmss.xls was created by default name to store in C:\ClickBP\dll.
Sending Measurements Using Email
1. You can use the “Record screen” (click Record to display “Record screen”).
2. Select measurement date(s) from date list you want to send over email.
3. Click Email. A new email screen displays with the selected measurements.
4. Send email to the
Tip: Using the “Options screen” to input an ‘email to’ address for the person who takes care of your health.
who takes care of
health.
Printing Measurements
1. You can use the “Record screen” (click Record to display “Record screen”).
2. Select measurement date(s) from date list you want to print.
3. Click Print. A print preview screen displays with the selected measurements.
4. Select printer and set up printing preference to print.
Deleting Measurements
1. You can use the “Record screen” (click Record to display “Record screen”).
2. Select measurement date(s) from date list you want to delete.
3. Click Delete, A screen displays prompting you to confirm the deletion.
4. Click OK to delete.
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Reviewing or Deleting History Data Log
To review blood pressure measurements stored on your computer, click Log from navigation panel, the “Logs list” displays listing the stored measurements by measurement date and time.
Reviewing Result and Displaying Pulse Waveform, WHO BP Level Illustration
Click Log from navigation panel to display the “Logs list”, point to the selected log and click mouse “Left” button to review result and display pulse waveform and WHO BP level illustration.
mmHg meter pointer & color-coded result
Navigation panel
Logs list
The result of the measurement display on the top of the screen and result shown are color-coded based on the WHO/ISH classification.
The pulse waveform and WHO blood pressure level illustration display on the right portion of the screen.
Note: History pulse waveform and WHO blood pressure level illustration only available for the latest 50 logs.
Pulse Waveform
WHO blood pressure level illustration
Tip: In the “Logs list”, you can point to the respected header cell (such as measurement date/time, Systolic BP, diastolic BP or pulse rate) and click mouse “Left” button to sort all data in the “Logs list”.
Deleting Log
To delete log, you can point to the left-most cell of the selected log and click mouse “Right” button to confirm to delete it.
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MDMouse User Manual Model MD-100
Uninstalling the MDMouse-ClickBP Application
If you need to remove the MDMouse-ClickBP application from your computer, use the following steps:
1. Click Control Panel to display the Control Panel screen and Click Programs (or Programs and Features) to display the list of all installed software programs.
2. Select ClickBP and click Uninstall. A prompt screen displays. Click Yes to delete the MDMouse-ClickBP application.
Wait couple of seconds until the device driver uninstall is complete, click “X” to close the
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Care of Your MDMouse Monitor
Your MDMouse blood pressure monitor requires no maintenance and simple care to keep it clean. Dirt or smudges on the MDMouse are easily cleaned with a lightly-dampened cloth. Do not use chemical cleaners as they could damage the bladder or components.
Clean the device with a soft, damp cloth.
The dirt on the cuff can be cleaned by the moisten cloth and soap.
Do not flush the device and cuff with water.
Do not bend or fold the cuff.
Do not place a sharp or pointed object again the cuff. Doing so may scratch or cut the cuff and damage the air bag.
Do not dismantle the device or disconnect the cuff or try to repair by yourself. If any problem happens, refer to the distributor.
Do not operate the device under the severe environment of extreme temperature or humidity, or direct sunshine.
Do not shake the unit violently.
Do not use an alcoholic-base or solvent agent to clean the device.
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 the cuff or use sharp objects on the cuff which could damage the air bladder.
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 sus-
tainable 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.
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MDMouse User Manual Model MD-100
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
The inflatable cuff doesn't de­flate after a measurement
Measurements seem erratic or vary significant­ly from meas­urement to measurement.
1) Stop and restart the MDMouse application and try again.
2) Disconnect the MDMouse USB cable and reconnect.
1) Stop and restart the MDMouse application and try again.
2) Disconnect the MDMouse USB cable and reconnect.
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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MDMouse User Manual Model MD-100
Error Messages
You may encounter one of the following error messages when using the MDMouse monitor. If so, please see the following description and follow the onscreen directions:
Error Message Description
Malfunction - Please Measure Again
Communication Er­ror - Reconnect MDMouse
Inlfation Malfunction
- Please Measure Again
Deflation Malfunc­tion - Please Meas­ure Again
Finger Ring
Too Readjust the finger cuff and measure again. Make sure the Loose - Readjust and Measure Again
Finger Ring Too Tight
- Readjust and Measure Again
A problem occurred when during operation. If the problem persists, try disconnecting and reconnecting the MDMouse and try again.
A data communication error between the MDMouse and your PC has occurred. Disconnect the USB cable and recon­nect
A problem occurred when inflating the finger cuff. Readjust the cuff and try measuring again. Keep your finger still since movement can affect measurements
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
cuff is snugly tightened at the base of the left index finger
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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Product Specification
Product name
Form factor
Measuring method Oscillometric method
Measuring range Pressure: 55-200 mmHg
Accuracy Pressure: ± 3 mmHg
Pressure inflation
Pressure deflation
Pressure release device
Sensor
SYS/DIA
Pulse 40 - 200 per minute
Measuring resolution
Measuring type
Cuff specification
Operating temperature / hu-
midity Storage temperature / hu­midity
MD Mouse
External
Pulse rate: 40-200 pulses/min
Pulse: ± 5% of reading value
Automatic pump actuated device
Automatic linear pressure deflation valve
Automatic solenoid venting valve
Semiconductor pressure sensor
55 - 200mmHg
1 mmHg
Left Index Finger
Designed for Left Index Finger circumference: 1.5' ~ 3.5' (3.7 cm~8.8 cm)
10 ~ 40°C(50 ~104°F) 30% ~ 85% R.H.
10 ~ 40°C(50 ~104°F) 15% ~ 90% R.H.
Data transmission
Power source
Computer Mouse movement detection
Mouse Movement resolution
Mouse Interfaces
Mouse Features
Dimension 125(L)X65(W)X46(H) mm
Weight 158 g USB cable 145 cm
Connection to PC Using USB cable
PC USB DC 5V 500mA Optical
1000 dpi
1* mouse - Generic USB type
Scrolling wheel
If your blood pressure measurement value is beyond the range of the device (SYS/ DIA 55-200mmHg), the device will display a message that recommends you consult a doctor.
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MDMouse User Manual Model MD-100
Software and Product Update
Any updated information or software download will be posted in our web site at www.mdmouse.com. Please check periodically for any news or updates.
About Us
The MDMouse monitor was developed by CalHealth, Inc. in California and manufactured in China.
CalHealth, Inc.
10620 Treena Street Suite 230 San Diego, CA 92131 www.mdmouse.com
Ya Horng Electronic Co., LTD.
No. 35, Shalun, Anding District., Tainan, Taiwan Factory: Atten Electronic (Dongguan) Co., Ltd.
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MDMouse User Manual Model MD-100
Warranty
CalHealth warrants your MDMouse MD-100 blood pressure monitor against defects in mate­rial or workmanship for a period of one (1) year after date of purchase.
Who is Covered?
You must have proof of purchase to receive warranty service. A receipt or other document showing that you acquired the MDMouse product is considered proof of purchase. THIS LIMITED WARRANTY EXTENDS ONLY TO THE ORIGINAL CONSUMER ACQUIRER OR ANY PER­SON RECEIVING THE MDMOUSE PRODUCT AS A GIFT FROM THE ORIGINAL CONSUMER AC­QUIRER AND TO NO OTHER ACQUIRER OR TRANSFEREE. THIS WARRANTY DOES NOT EX­TEND TO COMMERCIAL USERS.
This warranty applies only for product purchased and used in the United States. MDMouse product offered in countries other than the United States may or may not be covered under warranty offered by the product distributor in your country. Please contact that distributor for further information on warranty coverage in that country.
What is Covered?
Warranty coverage begins the day you acquire the MDMouse product. From one (1) year from the acquisition date, at the option of CalHealth, the MDMouse product will be repaired or replaced with a new, repaired, refurbished, or comparable product (whichever is deemed necessary) if it becomes defective or inoperative.
This exchange is done without charge to you for parts and labor. You will be responsible for the cost of shipping to a location designated by CalHealth. CalHealth will be responsible for the costs of shipping the replacement product to you. If CalHealth cannot reasonably re­pair or replace the MDMouse product then CalHealth may, at is sole discretion, refund the price you paid for the product.
All products, including replacement products, are covered only for the original warranty pe­riod. When the warranty on the original product expires, the warranty on the replacement product also expires. After one (1) year from the date of purchase, you pay for the re­placement of all parts and for all labor charges.
SOME STATES DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS, SO ABOVE LIMITATIONS MAY NOT APPLY TO YOU.
What is Excluded?
Your MDMouse warranty does NOT cover:
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MDMouse User Manual Model MD-100
Product replacement because of misuse, accident, lightning damage, unauthorized repair, or other cause not within the control of CalHealth.
Incidental or consequential damages resulting from the product. SOME STATES DO NOT ALLOW EXCLUSION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE EXCLUSION MAY NOT APPLY TO YOU.
Any modifications or changes to the product, including but not limited to software or hardware modification in any way other than as expressly authorized by CalHealth will void this limited warranty. Except in the case of hardware or soft­ware provided by CalHealth, installing software modifications, “hacks”, or using ser­vice access or “back doors” will void this limited warranty.
A product used for commercial or institutional purposes.
Keep Your Documentation
Please keep your receipt or other document showing proof of purchase. Attach it to the Quick Start user guide provided with your MDMouse product. It is also recommended that you keep the original box and packing material in case you need to return your product.
We also recommend that you visit our website, www.mdmouse.com/support and register your monitor after purchase. Product registration is not required for warranty coverage. Product registration does not eliminate the need for the consumer to maintain the original proof of purchase in order to obtain warranty benefits. In the event that you do not have proof of purchase date, the purchase date for purposes of warranty will be the date the product was manufactured.
Requesting Repair Service
Before requesting repair, please check the troubleshooting section of this user manual. If you are still unable to resolve the problem and wish to request warranty service, you may con­tact CalHealth at support@mdmouse.com . Please describe the nature of your problem in your email. In the event that product return is needed, you will be provided a Return Ma­terial Authorization (RMA) number and will be directed where you may send your MDMouse product for repair.
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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 User Manual Model MD-100
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.
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