Mocacare Mocacuff User Manual

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Instruction Manual
Automatic Wrist Blood Pressure Monitor
Medical grade technology meets elegant, compact design.
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Table of Contents
Medical Disclaimer
Intended Use
Measurement Method
Accuracy
Precautions
Device Overview
Symbol Denitions
Features
Installing Batteries
02
02
03
06
07
08
12
14
16
23
Applying the Cu
Positioning Guide
Measurement Procedure
Memory Function
Bluetooth Transmission
Storage and Maintenance
Troubleshooting
Warranty & Recalibration
Specications
Note
Appendix
25
26
27
31
33
35
37
39
40
42
46
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Medical Disclaimer
This manual and product are not meant as a substitute for advice provided by your doctor. You are not to use the information contained herein, or this product for diagnosing or treating a health problem or prescribing any medication. If you have or suspect that you have a medical problem, promptly consult your healthcare provider.
Intended Use
MOCACuff automatically measures human’s Systolic, Diastolic blood
pressure and heart rate by using the oscillometric method during deation.
All values can be read out in one LCD panel. Measurement position is at human being’s wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging from
5.3 inches to 7.7 inches (approx. 135 mm to 195 mm) and for home use. MOCACuff detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level.
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About Blood Pressure
What is blood pressure?
Blood pressure is the measurement of the force of blood pushing against
the walls of the arteries. Arterial blood pressure is constantly uctuating
during the course of the cardiac cycle. The highest pressure in the cycle is called the systolic blood pressure, and represents the pressure in the artery when the heart is beating. The lowest pressure is the diastolic blood pressure, and represents the pressure in the artery when the heart is at rest. Both the systolic and the diastolic pressure are necessary for a physician to evaluate the status of a patient's blood pressure. Many factors such as physical activity, anxiety or the time of day, can influence your blood pressure. Blood pressure is typically low in the mornings and increases from the afternoon to the evening. It is on average lower in the summer and higher in the winter.
Why is it useful to measure blood pressure at home?
Having one's blood pressure measured by a doctor in a hospital or a clinic, is often associated with a phenomenon called "White Coat Hypertension" where the patient becomes nervous or anxious, thus raising his blood pressure. There are also numerous other factors that
might cause your blood pressure to be raised at a specic time of day.
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This is why medical practitioners recommend home monitoring as it is important to get readings of blood pressure during different times of the day to really get an idea of your real blood pressure. Medical practitioners generally recommend the "Rule of 3", where you are encouraged to take your blood pressure three times in a row (at 3 ~ 5 minute interval), three times a day for three days. After three days you can average all the results and this will give you an accurate idea of what your blood pressure really is.
WHO blood pressure classications
Standards for assessment of high or low blood pressure without regard to age, have been established by the World Health Organization (WHO), as shown in the chart. However this chart is not exact for
classication of blood pressure and it's intended to be used as a guide
in understanding non-invasive blood pressure measurements. Please consult with your physician for proper diagnosis.
Systolic
(mmHg)
n
Diastolic
(mmHg)
Severe Hypertension
110
105
Moderate Hypertension
100
Mild Hypertension
95
90
High-Normal
85
Normal
80
Optimal
4
130 140 160 180150 170120
Red
Red
Red
Orange
Yellow
Green
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Variations in blood pressure
Individual blood pressures vary greatly both on a daily and a seasonal basis. These variations are even more pronounced in hyper tense patients. Normally the blood pressure rises while at work and is at its lowest during sleeping period. (hyper tense: means a person who has high blood pressure symptom.) The graph below illustrated the variations in blood pressure over a whole day with measurement taken every five minutes. The thick line represents sleep. The rise in blood pressure at 4 PM (A in the graph) and 12 PM (B in the graph) correspond to an attack of pain.
160
140
120
100
80
60
40
20
blood pressure (mmHg)
A B
(Direct arterial pressure recording in unrestricted man.
23222120 11101918171615141312
24 8765432
1 9
Time
Beven, Honour & Stott: Clin. Sci. 36:329. 1969)
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Measurement Method
MOCACuff Automatic Wrist Blood Pressure Monitor measures blood pressure and heart rate by oscillometric method, meaning the fluctuations in pressure are measured. Once the cuff is wrapped around your wrist, just turn on the monitor and inflation
automatically starts. The ination of the cu creates pressure around
the arteries inside the wrist.
Within the cu is a gauge which senses the uctuations (oscillations)
in pressure. The fluctuation measured represents the degree of intensity that your arteries contracting with each heart beat, and
also a result of the pressure that the cu has placed on the wrist. The
monitor measures these contractions and converts the information to a digital value. This is the result displayed on the monitor screen.
Once the measurement is complete, the cu will automatically deate.
NOTE
• The patient is an intended operator.
• The applied part is the cu.
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Accuracy
MOCACuff Automatic Wrist Blood Pressure Monitor has been clinically tested against a scientific device called a mercury sphygmomanometer, considered the gold standard in blood pressure measurement.
All MOCACuff Automatic Wrist Blood Pressure Monitors have performed equivalent to measurements taken with this scientific device and are within the accuracy limits prescribed by the American National Standard for Electronic or Automated Sphygmomanometers. The SPHYGMOMANOMETER was clinically investigated according to the requirements of ISO 81060-2:2013.
• We suggest our users have their blood pressure monitor checked every 2 years. This operation should only be performed by Manufacturer or by authorized representatives.
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Precautions
• Do not use this manual and product as a substitute for advice, diagnosing or treating a health problem or prescribing any medication by your doctor. If you have a medical problem, promptly consult your healthcare provider.
• Read the Instruction Manual thoroughly before measuring and keep it at hand for your reference at any time.
• This device uses the oscillometric method to measure systolic and diastolic blood pressure as well as your heart rate. It’s recommended for use by people over the age of 18 and not to be used on infant or children.
• The device is designed for home use and not suitable for clinical use.
• This monitor is not intended for use in the MR environment.
• Do not take a measurement in a low (less than 41 °F/5 °C) and high (more than 104 °F/40 °C) temperature, nor in a place outside humidity ranges (15% ~ 93% R.H.), and atmospheric pressure ranges (700 ~ 1060 hPa), or you may get inaccurate readings.
• Wait 30 ~ 45 minutes before measurement if you’ve just consumed caffeinated beverages or smoked cigarettes.
• Rest at least 5 ~ 10 minutes before taking a measurement.
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• To allow your blood vessels to return to the condition prior to taking the measurement, please wait at least 3 ~ 5 minutes in between measurements. You may need to adjust the wait time according to your personal physiological situation.
• We recommend you using the same wrist (preferably the left wrist) and measuring around the same time each day.
• Sit down comfortably and place your elbow on the table with
your feet at on the oor. Please do not cross your legs during
measurements.
• Keep the device at heart level. Relax your hand with the palm facing up.
• Perform measurements in a quiet and relaxed environment at room temperature.
• Do not move or shake the device during a measurement. Please keep quiet and do not talk during measurements.
• This product is not suitable for: with arrhythmias
4.
Currently in a dialysis treatment
• For those who have had mastectomy surgery (especially whose’ lymph nodes removed), it’s recommend take a measurement on the unaffected side.
• When used among medical electronic equipments on the same limb, pressurization of the cuff may cause temporarily malfunction to other devices.
3.
Undergoing intravenous injection on any limb
1.
Pregnant women 2. People
5.
In pre-eclampsia condition.
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• Keep in mind that blood pressure naturally varies from time to
time through out the day and is aected by lots of dierent
factors such as stress, eating, smoking, alcohol consumption, medication, and physical activity, etc.
• Normally the blood pressure rises while at work and is at its lowest during sleeping period.
• Blood pressure measurements should be interpreted by a physician or a trained health professional who is familiar with your medical history. Using the unit and recording the results regularly for your physician to interpret, you will keep your physician informed of the continuing changes in your blood pressure.
• If you have one of the circulatory problems as arteriosclerosis, diabetes, liver disease, kidney disease, severe hypertension, peripheral circulation….., please consult your healthcare professional before using the device.
• Blood pressure measurements taken with this device are equivalent to those obtained by a trained observer using the cuff/ stethoscope auscultation method and are within the accuracy limits prescribed by the American National Standard for Manual, electronic, or Automated Sphygmomanometers.
• Results are not intended for direct diagnosis. Please consult with a physician if you have any questions or concerns about your results.
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ATTENTION
1. Do not use the device on infants, children, or those who cannot express their own intention.
2. The device is equipped with sensitive electronic components. While measuring, avoid strong electrical or electromagnetic
elds, e.g. mobile phones, microwave ovens, etc; or it may lead
to temporary reading error or inaccuracy.
3. Consider the electromagnetic compatibility of the device (ex. power disturbance, radio frequency interference etc.) Please use it indoor only.
4. Over high frequency measurements may result in blood ow
interference, which is likely to cause uncomfortable sensations, such as partial subcutaneous hemorrhage, or temporary numbness to your wrist. In general, these symptoms should not last long. However, if you do not recover in time, please seek your medical practitioners for help.
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Device Overview
Product components
LCD Display
Risk Category Indicator
Mode Button
Set Button
(AAA "LR03"(1.5V) Alkaline Battery x 2 )
Storage Case
Memory Button
Start/Stop Button
CAUTION
Substitution of a component dierent from that supplied might result in
measurement error.
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Device Overview
Unit display
Hour : Minute (Also represents YEAR in Setting Mode)
Month / Date
Bluetooth Symbol Blood Pressure Unit
Low Battery Symbol
Memory Record Number
Pulse Symbol
Irregular Heartbeat Detector
Systolic Rate
Risk Category Indicator
Heart Rate Diastolic Rate
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Symbol Definitions
SYMBOLS
LOW BATTERY SYMBOL
PULSE SYMBOL
IRREGULAR HEARTBEAT DETECTOR
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DEFINITIONS
This symbol appears when the battery power is excessively low or the polarity reverses.
We suggest you replace all batteries with new ones, and make sure the +/­polarities are properly positioned.
Once pulse is detected, the symbol
ashes with each pulse beat.
Our suggestion: Please do not talk or move during measurements.
This symbol appears for 1 minute when the user was talking, moving, shaking, or an irregular heart beat was detected during measurements.
Our suggestion: Please do not talk or move during measurements. Repeat the measurement after resting for at least 5 minutes, and restart your measurement while sitting down comfortably and quietly.
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SYMBOLS DEFINITIONS
BLUETOOTH SYMBOL
RISK CATEGORY INDICATOR BAR
MEMORY RECORD SYMBOL
LCD displays this symbol when Bluetooth Function turns ON.
The arrowhead points out the specic
Risk Category that your measurement
reading ts in.
This symbol goes along with gures
according to the order of reading stored in the memory.
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Features
Risk Category Indicator
This device is equipped with Risk Category Indicator which classies
your blood pressure measurements into six stages (Optimal to Severe hypertension) as shown in below chart:
Stages of Blood
Pressure Levels
Grade 3
Severe Hypertension
Grade
Moderate Hypertension
Grade 1
Mild Hypertension
High-Normal
Normal
Optimal
Sytolic
Diastolic
(mmHg)
(mmHg)
≥180
≥110
2
160~179
100~109
140~159
90~99
130~139
85~89
120~129
80~84
<80
<120
After each measurement is completed, LCD display will show your position automatically on the six segments of the bar indicator which corresponds to Risk Category Indicator.
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Recommendations by SIGN49:
Color
Hypertension in older people
Confirm immediately and repeat BP in one day and
Red
again within one week depending on clinical situation.
Red
Serial blood pressures repeated within one month.
Provide advice about lifestyle modification and confirm
Red
within two months.
Provide advice about lifestyle modification and
Orange
recheck in one year.
w
Yello
Recheck in 2-5 years. (patients aged > 75
years offered annual health check)
Green
*Source: WHO,2003
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Diastolic
(mmHg)
Severe Hypertension
110
105
Moderate Hypertension
100
Mild Hypertension
95
90
High-Normal
85
Normal
80
Optimal
NOTE
130 140 160 180150 170120
Systolic
(mmHg)
Red
Red
Red
Orange
Yellow
Green
When a person’s systolic and diastolic pressures fall into dierent
categories, the higher category should apply.
e.g. systolic rate 181 & diastolic rate 99 Red category (Severe Hypertension)
e.g. systolic rate 110 & diastolic rate 95 Red category (Mild Hypertension)
The above table is not exact for classication of blood pressure and it's
intended to be used as a guide in understanding non-invasive blood pressure measurements.
Usually this is not a cause for concern; however we recommend you consult with your physician for proper diagnosis or seek medical advice according to our recommendation mentioned above. Please note that the device does not appropriate to diagnose hypertension, and it is only for user reference on blood pressure monitoring.
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Features
Irregular Heartbeat Detector
The symbol will appear on screen indicating a certain heartbeat irregularity was detected during measurement.
The heartbeat rhythm that is more than or less than 25% from the
average rhythm is usually dened as an irregular heartbeat rhythm.
Talking, moving, shaking or an irregular pulse during the measurement can result in the appearance of this symbol. Usually this is not a cause for concern, however if the symbol appears often, we recommend you seek medical advice. And please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.
NOTE
• The pulse display is not suitable for checking the frequency of heart pacemakers. If a certain pulse irregularity is detected during measurement often, we recommend you seek medical advice.
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• As a safeguard, we recommend that if you have arrhythmias such as atrial or ventricular premature beats and atrial
brillation or any other special conditions you should check
with your physician before using your device.
• The IHB function is not designed for use by people with arrhythmias nor for diagnosing or treating an arrhythmic
problem. In order to lter the unstable status of user and avoid aecting the detection of heart rate from any movement,
shaking or talking in the beginning of measurement, the method of averaging heart beat intervals of subject device is calculated with the three proper heart beat pulses detected in
the beginning of measurement and that is dierent from a
strict mathematical averaging of all recorded intervals.
• At least 3 beats with at least 25 % dierence from the average
heart beat interval will generate the IHB icon on the screen.
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Features
Bluetooth Data Transmission
MOCACu features a built-in "Bluetooth Data Transmission" function,
which enables the device automatically transmit measuring results to paired Bluetooth-enabled device after measurement. When connection established, BPM would transmit memory data such as Measure Date, Systolic, Diastolic and Pulse to the Bluetooth enabled device.
If paired Bluetooth-enabled device is not working or is not within RF range of this device, the measuring results will be stored in the blood pressure monitor's memory. Besides, user can press " " button for one time to open the Bluetooth function.
Bluetooth compatibility
Bluetooth-enabled device is:
• Bluetooth 4.0 for Android 4.3 or above,
• Bluetooth 4.0 for iOS 7.0 or above
20
with blood pressure monitor for
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Features
NOTE
• MOCACu is subject to and complies with electromagnetic
compatibility (EMC) standard of IEC 60601-1-2, EN 301 489-1, EN 301 489-17, EN 300 328 and U.S. federal guidelines, Part 15 of the FCC (Federal Communications Commission) rules for devices with RF capability. These guidelines help ensure that
your device will not aect the operation of other nearby devices. Additionally, other devices should not aect the use of your device.
• Other wireless devices that are in use nearby, such as a cell or mobile phone, or a wireless network, may prevent or delay the transmission of data from your device to paired Bluetooth­ enabled device. Moving away from the source of the interference
or turning o these devices to resolve the problem.
• Make sure MOCACu and paired Bluetooth-enabled device are
within acceptable distance (no more than 10 meters) with each other. If not, put them closer.
• Be sure to select the correct User on the monitor before your blood pressure measurement begins.
• Bluetooth date transmission is not available under measurement.
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Features
Application Software for Bluetooth
To fully utilize this feature, users need to ensure Bluetooth support of Wireless (usually under settings menu) on their Android or iOS device for contactless data exchange. Then, download and install
MOCACARE
" Bluetooth-enabled device which is compatible with Android 4.3 or iOS
7.0 or above. Please follow the following steps for installing:
1. To install store, and search for
2. Click the INSTALL button. Once installed, click on MOCACARE app APP icon.
3. Now you can start using your Android version or iOS version
MOCACARE
of log, track and trend your test results from your Bluetooth-enabled Device.
NOTE
MOCACARE
and instructions of how to activate them.
22
app" application software from Google Play on the
MOCACARE
app Software Manual contains explanations of functions
FREE APP, go to the Google Play APP
MOCACARE
app with Bluetooth feature, it’s a simple tool to
app.
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Installing Batteries
When LOW BATTERY SYMBOL appears on the display, or no reaction toward operation, please change batteries. Replace all worn-out batteries with new ones and do not mix new and used batteries. Do not mix alkaline, standard (carbon-zinc) or rechargeable cadmium batteries
either. Such action may shorten the battery life or cause the device to malfunction.
Slide the battery cover and insert 2 AAA (LR03) alkaline batteries into the battery compartment as shown on the figure below. Make sure the polarities "+" and "–" ends are coinciding with similar markings engraved on the
battery housing.
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Attention
• Batteries are hazardous waste. Do not dispose of them together with the household garbage. Please discard worn-out batteries to the recycling site according to local regulations.
• Keep the battery away from children in case they choke on it.
• To prolong the battery life and prevent damage caused by leakage, remove the batteries from the device if the device is not to be used for a long period.
• The device will keep the last measuring results after changing batteries, please reset date and time.
• Please replace all worn-out batteries with new ones when you are operating the Bluetooth transmission function, and the LOW BATTERY SYMBOL appears on the display.
• All batteries used must be the same type. Do not mix alkaline, standard (carbon-zinc) or rechargeable (cadmium) batteries. Do not mix old and new batteries.
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Applying the Cuff
1. Do not place the pressure cu over a jacket or sweater sleeve. Wrap
the pressure cu around the bare wrist with the monitor facing you.
2. Wrap the cu snugly. Do not make
it too tight.
3. Fold the remaining part of the cu
back out of the way.
4. Leave approximately 0.4 inch
(10 mm) between the cu and the
bottom of your hand palm.
3. 4.
2.
0.4inch(10mm)
NOTE
• Do not use this device if your wrist has any wound or injury.
• Do not wrap the cu around any body part other than your wrist.
5.3 ~ 7.7 inch (135 ~ 195 mm)
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Positioning Guide
It is extremely important that the cu be at the same height as the heart. Having the cu higher or lower may cause inaccurate results.
1. Sit down comfortably with
your feet at on the oor and
back supported.
2. Position the blood pressure monitor on your wrist.
3. Place your elbow on the table and rest the back of your hand on the device storage case or other object.
4. Rest your wrist on the armrest until it’s at the same height as your heart. (Position 1)
5. Relax your hand and turn your palm upwards.
6. For more accurate measurements , hold your arm across your chest at heart level. (Position 2)
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Position 1
Position 2
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Measurement Procedure
Switch on the Monitor
A.
Press button to switch
on the monitor.
B.
All segments appear on the
screen.
Setting Year, Date and Time
A.
Press button ("YEAR"
ashes). Press button to
adjust YEAR value.
B.
Press button ("MONTH" ashes). Use button to adjust
MONTH (1, 2, 3,……, 12).
C.
Adjust DATE (1, 2, 3,…, 31), HOUR (1, 2, 3,……..12PM,1 PM,…,
12) and MINUTE (00,01,02,03,.....59) as described in Step A above.
D.
When settings are done, press button to conrm the above
settings. The device is ready to measure.
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Measurement Procedure
Turning Bluetooth Feature ON/OFF
User can press and hold button 3 seconds to turn the Bluetooth feature ON/OFF in Standby Mode.
Bluetooth feature ON
Bluetooth feature OFF
NOTE
• The Bluetooth Feature Switch default setting is ON
• Once Bluetooth Feature turns ON, the LCD appears Bluetooth symbol in any mode.
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Get Started
A.
With the cu wrapped around
your wrist, press button to start measurement. All display units appear on the screen.
NOTE
Do not inate the cu until it is wrapped around your wrist.
B.
After all symbols disappear, the display
will show "00". The monitor is "Ready to
Measure" and will automatically inate
to the level that is right for you.
C.
After ination of the cu, the pressure
will slowly decrease. When pulse is
detected, PULSE SYMBOL ashes.
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Measurement Procedure
NOTE
• If the cu does not stop inating, remove the cu at once.
• To stop measurement, press button. The cu will deate
immediately after the button is pressed.
D.
LCD screen displays your systolic rate, diastolic rate, pulse, Risk Category Indicator Bar, and Irregular Heartbeat Detector symbol (if any) with date and time for 1 minute.(Year and Date / Time display alternate automatically)
E.
Without any operation for 1 minute,
device automatically shuts o.
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Memory Function
Storing data
After each measurement, the systolic and diastolic pressure, heart rate with date and time will be automatically stored. The monitor can store up to 99 memory sets for one user, and automatically replace the oldest data with new one.
Recalling data
A.
Press button to enter Memory
Mode. LCD displays average of last
3 measuring results rst.
B.
Press button again, LCD displays
the latest measuring result. Use
button to scroll through all stored
measuring results. (Year and Date /
Time display alternate automatically)
C.
To stop reading memories, press
button, and switch to Standby Mode.
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Erasing data
Erasing data
A.
Press button to enter Memory Mode.
B.
Press and hold and buttons at the
same time, the data will be erased automatically.
C.
To conrm the data in the selected user has
been erased, press button and no data should appear.
NOTE
ONCE DELETED, YOUR DATA CAN NOT BE RESTORED.
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Bluetooth Transmission
To activate Bluetooth function, please make sure your Bluetooth-enabled device have downloaded APP, and follow pairing instruction.
There are 2 ways to process Bluetooth Transmission if Bluetooth function is ON:
Measurement Completed
1. After measurement completed, the device activates Bluetooth function automatically, and the Bluetooth Symbol will begin ashing on the screen.
2. While transmitting the reading to your Bluetooth-enabled
Device, MOCACu Bluetooth Symbol will remain steady
on the screen.
3. MOCACu can only pair up with
one Bluetooth-enabled device at a time. To transmit measuring results to other Bluetooth-enabled device, please retry Steps 1 ~ 2.
Bluetooth Symbol lit constantly
under transmission
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Press button for one time:
Under Standby Mode,
1. Press button for one time to wake up the device and starting Bluetoothfunction (Bluetooth Symbol
ashing).
2. While transmitting the reading to your Bluetooth­ enabled Device, MOCACuff Bluetooth Symbol will remain steady on the screen.
3. MOCACuff can only pair up with one Bluetooth-enabled device at a time. To transmit measuring results to other Bluetooth-enabled device, please retry as mention above.
Date/Time Synchronization
1. The BPM’s Date/Time Setting can be synchronized by Bluetooth-enabled device (e.g. smart phone) which has downloaded and installed MOCACARE application software.
2. When Bluetooth connection is established, the Bluetooth­ enabled device can send commend with the date/time information to BPM and the BPM’s date/time will be updated.
NOTE
• Without any operation in 1 minute, the device shuts o automatically and Bluetooth Transmission OFF.
• Standby Mode: Segments appeared but not under BPM measuring or data transmitting.
• Sleeping Mode: Clear all LCD segments.
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Maintenance and Storage
General Use
• Do not in any way twist the cu.
• Do not press button if the cu is not wrapped around the wrist.
• Do not drop the product and avoid any strong impacts.
Maintenance
• Use a piece of cloth with water or mild cleansing agent to wipe the device and dry it immediately with a dry cloth.
• Do not use detergent or any strong chemicals to clean the device.
• Disinfection - Use a piece of cloth with a dilution of neutral
detergent or soapsuds to wipe the surface of the cu for 10 seconds.
• Make sure the cu is completely dry before using.
• Do not attempt to disassemble or change any parts of the
monitor, including wrist cu, due to substitution of a component dierent from that supplied might result in measurement error.
• If any suggestion or service is requested, please consult your service station.
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• Do not implement the maintenance procedures for equipment during measurement.
• Only trained technicians are allowed to repair and dissemble the device, including software upgrades, patches and maintenance.
NOTE
Water quality required for cleaning and disinfection: Tap water.
Storage
• If the device is not to be used for a long time, please remove the batteries from the device (leaking of battery acid can cause the device to malfunction).
• Always store the unit in the storage case after use. It is intended to be transported or stored in a carrying case between uses.
• Do not place the device directly under sunlight, in high temperature, or in humid or dusty places.
• Do not store the device in extremely low (less than –13 °F/–25 °C) and high (more than 158 °F/70 °C) temperature, nor in a place its humidity exceeds 93% R.H.
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Troubleshooting
SYMBOLS / SYMPTOMS
Unit does not turn on when button is pushed.
Measuring Error Symbol appears when blood pressure value displayed is excessively low or high.
Measuring Error Symbol
Measuring Error Symbol
Measuring Error Symbol
Note: If "EP" appears on the display, just return the device to your local distributor or importer.
CONDITIONS / CAUSES
Worn-out batteries.
Battery polarities have been positioned incorrectly.
Cu has been placed
incorrectly.
Did you talk or move during measurement?
Shaking of the wrist
with the cu on.
Air circuit abnormality.
Cu tube may not be
plugged into monitor correctly.
Ination pressure
exceeding 300 mmHg.
Can’t determine blood pressure measurement data.
INDICATION/ CORRECTION
Replace them with 2 new AAA (LR03) alkaline batteries.
Re-insert the batteries in the correct positions.
Wrap the cu
properly so that it is positioned correctly.
Measure again. Keep wrist steady during measurement.
Check cu connection.
Measure again.
Switch the unit o,
then measure again.
Wrap the cu properly
and keep steady. Measure again.
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Troubleshooting
SYMBOLS / SYMPTOMS
BPM cannot communicate with Bluetooth device
Note: If "EP" appears on the display, just return the device to your local distributor or importer.
38
CONDITIONS / CAUSES
Paring has not been completed.
Bluetooth function is not turn on.
The distance between BPM and Bluetooth device is out of transmitting range.
Use an incompatible Bluetooth device.
Use non- Bluetooth device.
Unexpected loss of electrical/mechanical integrity.
INDICATION/ CORRECTION
Please re-pairing the BPM and Bluetooth device with each other.
Please refer to Page 27 "Measurement Procedure" and Page 33 "Bluetooth Transmission" to turn on the Bluetooth function.
Please make sure the acceptable distance (≤10 meters) with each other.
Please refer to Page 20 "Bluetooth compatibility" & Page 41 "RF
Specication".
Re-insert the batteries and try again.
Return the device to your local distributor or importer.
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Warranty & Recalibration
Warranty For One Year from the manufacturing date
Please note that this warranty does not cover damage caused by misuse or abuse; accident; the attachment of any unauthorized accessory; alteration to the product; improper installation; unauthorized repairs or modifications; improper use of electrical/power supply; loss of power; dropped product; malfunction or damage of an operating part from failure to provide manufacturer’s recommended maintenance; transportation damage; theft; neglect; vandalism; or environmental conditions; loss of use during the period the product is at a repair facility or otherwise awaiting parts or repair; or any other conditions whatsoever that are beyond the control of importers or distributors.
Recalibration Notice
To ensure continued measurement precision, all digital blood pressure monitors require recalibration regularly.
After 2 years from the manufacturing date, we recommend you have your monitor recalibrate at the local distributor or importer. The recalibration service plus the charge of shipping and handling fee shall be charged accordingly.
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Specifications
Model Number
Measurement Method
Rated Range of Cu Pressure
Rated Range of Determination
Measurement Range of Heart Rate
Unit Dimensions
Unit Weight(Cu & Batteries Excluded)
Transportation Environment
Operation Environment
Power Supply
Sleeping Mode
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Accuracy
Ination
Deation
Display
Memory
Cu Size
Storage/
Battery Life
Product Life
Accessories
MOCACu
Oscillometric 0~300mmHg 40 ~ 280 mmHg 40 ~ 199 beats/minute Pressure: ±3 mmHg Pulse: ±5 % Max.
Automatic Ination (Air Pump)
Automatic Air Release Control Valve. Liquid Crystal Display 99 Memory Total for one user. 74 X 74.5 X 30.5 mm (L X W X H)
2.91 X 2.93 X 1.20 inch (L X W X H)
97.5g±10g (3.44oz±0.35oz) 135 ~ 195 mm (approx. 5.3 ~ 7.7 inch)
Temperature: -25 °C ~ 70 °C (-13 °F ~ 158 °F)
Humidity: ≤ 93 % R.H.
Temperature: 5 °C ~ 40 °C (41 °F ~ 104 °F) Humidity: 15 % ~ 93 % R.H. Atmospheric pressure: 700 hPa ~ 1060 hPa
DC 3 V, AAA “LR03” (1.5 V) Alkaline Battery x 2
Approx. 200 Measurements 5 Years (4 times per day) Without any operation for 1 minute, device
automatically shuts o.
Instruction Manual, 2 AAA (LR03) Alkaline Batteries, Storage Case
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Specifications
Bluetooth 4.0 BLE
RF Type
RF Modulation
Eective Radiated Power
Data Throughput
Expected Delay (Latency Range) in Wireless (RF) Communication
Wireless Operation Distance
Need for Spectrum Management
Maximum Permitted Power
Proximity of Other In-band
Transmitters Used in Vicinity
Wireless Communication Prole
*The contents of this manual and the specications of the device covered by this
manual are subject to change for improvement without notice.
RF Frequency /
Maximum Limitation
Wireless Coexistence
System requirement of the
Bluetooth device
GFSK 0 dBm
0.2 Mbps
The latency time is less than 0.3 ms second from sender to receiver.
Channel Quality-Driven Data Rate (CQDDR)
Integrity
technology increases the eective data rate and
integrity in noisy environments.
AES-128 and application layer user dened
Security
Class 2 (Maximum: 10 meter) 2402 - 2480 MHz (allowing for guard bands)
Unlimited 5 mW Up to 40 bands (2 MHz spacing; centered from 2402 to 2480 MHz) GATT – Client and Server Support for 802.11 Coexistence
Bluetooth 4.0 for Android 4.3 or above Bluetooth 4.0 for iOS 7.0 or above
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Note
Follow instructions for use.
BF Classication:
- Internally powered equipment
- BF type applied part
- IP22-Degrees of protection provided by enclosures
- Not suitable for use in presence of ammable anesthetic
mixture with air or with Oxygen or nitrous oxide
- Continuous operation with short-time loading
To avoid inaccurate results caused by electromagnetic interference between electrical and electronic equipments, do not use the device near a microwave oven. At least keep a maximum output power of 2 W yields and a distance 3.3m away from this equipment.
Discard the used product to the recycling collection point according to local regulations.
Humidity limitation
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Manufacturer:
HEALTH & LIFE CO., LTD. 9F, No. 186, Jian Yi Road, Zhonghe District, New Taipei City, Taiwan. www.healthandlife.com.tw
Temperature limitAtmospheric pressure limitation
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Note
NOTE
This equipment 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 o and on, the user is
encouraged to try to correct the interference by one or more of the following measures: 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 the receiver.
• Connect the equipment into an outlet on a circuit dierent from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
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CAUTION:
To assure continued FCC compliance:
1. Any changes or modications not expressly approved by
the grantee of this device could void the user's authority to operate the equipment.
2. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with minimum distance 20cm between the radiator & your body.
FCC Label Compliance Statement:
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1)
this device may not cause harmful interference, and
(2)
this device must accept any interference received, including
interference that may cause undesired operation.
NOTE
"Changes or modifications not expressly approved by the manufacturer could void the user’s authority to operate the equipment".
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MOCACuff essential performance per IEC 80601-2-30 additional essential performance requirements:
• 201.12.1.102 Limits of the error of the manometer from environmental conditions
Over the temperature range of 5 °C to 40 °C (41 °F ~ 104 °F) and the relative humidity range of 15 % to 93 % (non-condensing), the maximum error for the measurement of the CUFF pressure at any point of the NOMINAL measurement range shall be less than or equal to ± 3 mmHg (± 0.4 kPa) or 2 % of the reading, whichever is greater.
• 201.12.1.107 Limits of the change in error of the blood pressure determination
The laboratory limits of the change in error of the BLOOD PRESSURE DETERMINATION of the AUTOMATED SPHYGMOMANOMETER shall be less than 3 mmHg (0.4 kPa).
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Appendix
Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environments listed below, and should only be used in such environments:
Emissions test Compliance
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage
uctuations/ icker emissions
IEC 61000-3-3
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Group 1
Class B
Not Applicable
Not Applicable
Electromagnetic environment – guidance
RF energy is used only to maintain device’s operation. Therefore, its RF emissions are so low that it’s not likely to cause any interference in nearby electronic equipment.
The device is suitable for use in all establishments, including domestic establishments, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
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Appendix
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environments listed
below, and should only be used in such environments:
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment – guidance
Electrostatic discharge (ESD) IEC 61000-4-2
Power frequency (50/60 Hz)
magnetic eld
IEC 61000-4-8
±6 kV contact ±8 kV air
3 A/m
±8 kV contact ±15 kV air
3 0A/m
The relative humidity should be at least 5%.
Power frequency magnetic
elds should be at levels
characteristic of a typical location in a typical commercial or hospital environment. Recommended separation distance
where I is the current in amperes in a power bus or an appliance wire and r is the recommended separation distance between your device and the power bus or appliance wire, in meters (m).
I
188
(m)
r =
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Appendix
Recommended separation distances between portable and mobile RF communication equipment and the device.
The device is intended for use in an electromagnetic environment where radiated RF disturbances are under control. User can help prevent electromagnetic interference by keeping the device at a minimum distance from portable and mobile RF communications equipment (transmitters). Below table details the maximum output power of transmitter:
Rated maximum output power of transmitter W
0.01
0.1 1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromag netic
propagation is aected by absorption and reection from structures, objects
and people.
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Separation distance according to frequency of transmitter(m)
150 kHz to 80 MHz Not applicable
NA NA NA NA NA
80 MHz to 800 MHz d = 1.2 p
0.12
0.38
1.2
3.8 12
800 MHz to 2.5 GHz d = 2.3 p
0.23
0.73
2.3
7.3 23
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Appendix
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environments listed below, and should only be used in such environments:
Immunity test
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
IEC 60601 test level
3 Vrms 150 kHz to 80 MHz
3 V/m 80 MHz to
2.5 GHz
Compliance level
Not Applicable
10 V/m 80 MHz to
2.7 GHz
Electromagnetic environment – guidance
Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2 √p 80 MHz to 800 MHz d = 2.3 √p 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
Field strengths from xed RF
transmitters, as determined by an electromagnetic site survey, less than the compliance level in each frequency rangeb . Interference may occur in the vicinity of equipment marked with the following symbol:
should be
a
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Appendix
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is aected by absorption and reection
from structures, objects and people.
a. Field strengths from xed transmitters, such as base
stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the
location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.
b. Over the frequency range 150 kHz to 80 MHz, eld
strengths should be less than 10 V/m.
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Contact us
More information please visit
www.mocacare.com
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P/N: 323102949 VER: 001
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