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.
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
andSelect 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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MDMouse User Manual Model MD-100
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.
1a. 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.
3a. 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.
4a. 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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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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MDMouse User Manual Model MD-100
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.
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.
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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MDMouse User Manual Model MD-100
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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MDMouse User Manual Model MD-100
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:
ProblemTry 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 MessageDescription
Malfunction - Please
Measure Again
Communication Error - Reconnect
MDMouse
Inlfation Malfunction
- Please Measure
Again
Deflation Malfunction - Please Measure Again
Finger Ring
TooReadjust 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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MDMouse User Manual Model MD-100
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, CA92131
www.mdmouse.com
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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MDMouse User Manual Model MD-100
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/ISO 81060-1:2007,ANSI/AAMI/IEC 80601-2-30:2009, ANSI/AAMI/ISO 81060-2:2009Non-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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