Avita BPM835-AJ User manual

Arm Type Blood Pressure Monitor
Model: BPM835-AJ
INSTRUCTION MANUAL
PLEASE READ THIS INSTRUCTION MANUAL COMPLETELY
BEFORE OPERATING THIS UNIT
EN
RoHS REACH
MDSS GmbH
Schiffgraben 41
30175 Hannover Germany
AViTA Corporation
9F., No. 78, Sec. 1, Kwang Fu Rd.,
San Chung Dist., New Taipei City 24158, Taiwan, China
China, AViTA(WUJIANG)
Importer
Distributor

Contents
Intended Use....................................................................................................................... 1
Type of Use/ Reuse........................................................................................................... 1
Intended User..................................................................................................................... 1
Important Information before Use ........................................................................... 3
Product Identification ..................................................................................................... 6
Description of LCD Display........................................................................................... 7
Battery Installation ........................................................................................................... 8
Setting the Date and Time............................................................................................ 9
Placement of the Pressure Sleeve............................................................................10
Measurement of Pulse Rate and Blood Pressure .............................................12
Hypertension Indicator ................................................................................................14
Irregular Heartbeat Detector.....................................................................................15
Atrial Fibrillation (AFIB).................................................................................................16
Memory Function ...........................................................................................................17
Error Codes........................................................................................................................19
Troubleshooting ..............................................................................................................20
Cleaning and Disinfecting...........................................................................................21
Technical Specification .................................................................................................22
EMC Tables.........................................................................................................................23
Explanation of Symbols................................................................................................25

1
Intended Use
The product automatically measures human being‟s Systolic, Diastolic
blood pressure and pulse rate by oscillometric method. The
measurement results are displayed on the LCD. Measurement position
is at human being‟s upper arm. The intended use of this
over-the-counter device is for adults with upper arm circumference
ranging from 220 mm to 420 mm (Approx.8.7 ~ 16.5 inches) and for
home use. When the device detects the appearance of irregular
heartbeats such as atrial or ventricular premature beats during
measurement, an indicated symbol will appear with measuring
readings.
This device is designed only for adults.
Type of Use/ Reuse
Multiple patient multiple use
Intended User
The Arm type blood pressure monitor is intended or both professional
and consumer, and the patient is the intended operator.
Patient selection criteria: Handicapped persons and children are the
exception, as of handicapped persons and children need assistance by
another person to use the device.
Contra-indications
Do not use in these cases: common arrhythmias such as atrial or
ventricular premature beats, atrial fibrillation, arterial sclerosis, poor
perfusion, diabetes, age, renal diseases, patient motion, trembling,
shivering

2
CAUTION:
•Beware of blood flow interference and resulting harmful injury to the
patient caused by continuous cuff pressure.
•While using monitoring ME equipment and blood pressure monitor
simultaneously being used on the same limb, pressurization of the
cuff may cause monitoring ME equipment temporarily dysfunction.
•Reading can be affected by the measurement site, the position of the
patient, exercise, or patient's physiologic condition.
•Automated sphygmomanometer can be affected by extremes of
temperature, humidity and altitude.
•Frequent measurements can cause injury to the patient due to blood
flow interference.
•Improper operation of automated sphygmomanometer may result in
prolonged impairment of patient blood circulation, please read
manual for proper use, if still not clear, contact professional health
care personnel or local distributor for assistant.
•Retake the measurement if unexpected readings are obtained
•Ensure that the cuff is not placed on an arm in which the arteries or
veins are undergoing medical treatment, e.g., intravascular access or
therapy, or an arteriovenous (AV) shunt.
•This product is suitable for use in the home healthcare environment.
•Keep this device out of the reach of children. Strangulation may result
from baby or child entanglement in cables.
•Please keep this device away from pets, pests, and children.
•Preventing potential allergic reaction, please avoid the device in
direct contact to patient's wound.

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•Do not use the cuff on people who have undergone a mastectomy.
•Do not apply the cuff over a wound, as this can cause further injury.
•Do not apply the cuff other then the original manufacturer provided.
•Do not use in these cases (e.g. Device for use in an ambulance,
helicopter or professional environment)
•Cuff pressure 0 –300 mmHg
•Reduction rate: ≦30S Refer to IEC 80601-2-30
•No modification of this equipment is allowed.
•High BMI health condition users may result varied.
•Users shall notify serious adverse event to the central competent
authority or its commissioned agency, legal entity, or manufacture.
Important Information before Use
1. Blood pressure measurements should only be interpreted by a
physician or a trained health care professional who is familiar with
your medical history. Through regular use of this device and
recording of your measurements, you can keep your physician
informed of the changes in your blood pressure.
2. Perform your measurement in a quiet place. You should be seated in
a relaxed position.
3. Avoid smoking, eating, taking medication, alcohol consumption or
physical activity 30 minutes prior to taking a reading. If you are
exhibiting signs of stress, avoid taking your measurement until the
feeling subsides.
4. Rest 15 minutes prior to taking a reading.
5. Remove any constrictive clothing or jewelry that may interfere with
the cuff placement.
6. Keep the monitor stable during measurement to achieve an
accurate reading. Remain still; do not talk during the measurement.

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7. Record your daily blood pressure and pulse readings on a chart.
8. Take your readings at the same time, each day or as recommended
by your physician to get an accurate indication of change in your
true blood pressure.
9. Wait a minimum of 15 minutes between readings to allow for the
blood vessels to return to normal. The wait time may vary
depending on your individual physiological characteristics.
10. Although such cases are rare, for those with an extremely weak
pulse or irregular pulse, errors may result which prevent proper
measurement. If abnormal variations are noticed, consult with your
physician or trained healthcare professional.
11. This device is intended for adult use. While taking a measurement,
you can stop the inflation or deflation process of the cuff at any
time by pressing the POWER button.
12. If any serious incident that has occurred in relation to the device
should be reported to the manufacturer and the competent
authority of the Member State in which the user is established.
13. Do not expose the device to extreme temperatures, humidity dust or
direct sunlight as this may cause it to malfunction.
14. Please comply with the storage and operating conditions defined in
„Technical Specification‟. Storing or using the device outside of
the specified temperature and humidity range can affect
measurement accuracy or the function of the device.
15. If the device was not stored within the minimum/maximum
permissible storage conditions, a waiting period of at least 2 hours
must be observed before using it under the specified operating
conditions („Technical Specification‟) or an ambient temperature
of approx. 20 °C.
For Customer Service, the blood pressure monitor is calibrated when
manufactured; it is recommended that the accuracy should be
maintained and calibrated by manufacture triennially (every 3 years). To
obtain the service please contact AViTA Corp. for the address of the

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repair location. Enclose with the Proof of Purchase. Include $10.00 USD
for the return shipping and handling. Accompany with a letter, with your
name, address, phone number, and description of the specific problem
or routine check-up. Pack the device carefully with bubble wraps (if
there is) to prevent damages cause during transit. Due to possible
losses in transit, it is recommended insuring the device with return
receipt requested. If in any way of assistance of setting up, using,
maintaining or to report unexpected operation/adverse events please
contact manufacturer or local representative for further assistance.

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Product Identification
1
Air socket
2
WHO Indicator
3
Start/Stop button (Power key)
4
Memory button ( M key)
5
Set button (S key)
6
Display
7
Cuff
8
Cuff connector
9
Cuff tube

7
Description of LCD Display
Low battery indicator
WHO indicator
Date & Time
Irregular Heartbeat Symbol
AF Symbol
Memory Symbol
Memory Set
Heartbeat Symbol
Pulse rate
Release air
Systolic Pressure
Diastolic Pressure

8
Battery Installation
Low battery warning:
It is necessary to replace the batteries when the Low Battery symbol
“ ” appears on the display, or when the display does not turn on
after the POWER key is pressed.
Replacing the Battery::
1. Press down on latch and lift the cover on the bottom of the monitor.
2. Insert or replace 4x 1.5 V AAA batteries into the battery
compartment, ensuring to match the indicated polarity symbols.
Always use new batteries.
3. Replace the battery cover.
CAUTION:
Risk of explosion if battery is replaced by an incorrect type. Dispose of
used batteries according to the instructions.
NOTE: Battery-operated
1. Please properly dispose of the batteries away from small children
and heat. Avoid the children accidentally swallow the battery.
2. It is recommended to remove the batteries if the unit will not be
used for more than 1 month.
3. Batteries must be disposed of in accordance with local
environmental and institutional policies.
4. It is recommended not to use rechargeable, unqualified or different
spec battery may damage the device or cause circuit shortcut.

9
Setting the Date and Time
It is necessary to set the date and time for the unit every time batteries
are initially installed or replaced.
To set the date and time, proceed as follows:
•While in power off mode, press and hold the “SET” key for at least 3
seconds to enter Date and Time setting procedure and the Year value
will begin to flash.
•Press the “SET” key to advance the display to the desired year, press
the “M” key to confirm the year.
•Next, the month will blink. Repeat step 2 to set the month and date,
then hours, then minutes.
•After setting the minutes, the unit will automatically exit out of the
date/time setting mode and shut off.

10
Placement of the Pressure Sleeve
It is important to avoid smoking, eating, taking medication, alcohol
consumption or physical activity 30 minutes prior to taking a reading. If
for any reason you are unable to or should not use your left arm, please
modify the instructions for cuff application to your right arm. Your
physician can help you identify which arm is best for you to take
measurements from.
1. Remove any constrictive clothing or jewelry that may interfere with
cuff placement.
2. Be seated at a table or desk with your feet flat on the floor.
3. The cuff should not be plugged into the monitor until after the cuff is
applied to your arm.
Note:
Blood pressure naturally varies from one arm to the other; therefore,
measure your blood pressure on the same arm to ensure comparability
of the two readings.
4. Position the cuff on a solid surface with the tubing facing up and
away from you. The metal ring/bar on the cuff should be to the left of
the tubing.
5. Open the cuff by pulling or rolling the bottom of the cuff to the right.
This should open the cuff without fully unrolling it, creating a cylinder.
Do not fully unwrap or unroll the cuff.

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6. Insert your left arm into the created cuff cylinder.
7. The bottom edge of the cuff should be positioned approximately one
inch above the elbow joint.
8. Reaching underneath your left arm with your right hand, pull the end
of the cuff towards your body to tighten the cuff. Wrap and secure the
cuff, making sure in place as shown.
9. The cuff should fit comfortably, yet snugly around your arm. You
should be able to insert one finger easily between your arm and the
cuff.
Note:
If you are not comfortable with applying your cuff, please seek the
assistance of another member of your household or work with your
physician to practice the cuff application. Incorrectly applied cuffs may
result in inaccurate readings.

12
Measurement of Pulse Rate and Blood Pressure
To set the user and memory zone, proceed as follows:
While in power off mode, press the “SET” key to select user. Confirm
your selection with the Power key to turn the power on and start to
measure your blood pressure. Or wait for 3 seconds, your selection is
then stored and shut off automatically.
1. Press the Power key to turn the power on. After full display is shown,
the values for the last reading will appear on the display. If there is no
measurement, the unit displays the value “0”.
2. After the self-test, the blood pressure monitor starts to measure. The
cuff will automatically begin to inflate, with the display showing the
increasing pressure in the cuff.
3. As the pressure increases, the indicator will increase upwards
according to the pressure value on the display.
4. As the cuff inflates, the monitor automatically determines your ideal
inflation level. This monitor detects your blood pressure and pulse
rate during inflation.

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5. To detect the heartbeat, the heartbeat symbol will appear and
continuous flashes on the LCD display.
6. Your blood pressure measurement and pulse will display
simultaneously on the screen.
7. The Hypertension Indicator will indicate your reading range on the
display separately.
8. Press the Power key to turn the unit off and conserve energy and
battery life.
The unit will automatically shut-off approximately 2 minutes.
Note:
1. Users are recommended to use BPM835-AJ daily at a fixed time,
frequency of usage from 1 to 3 times can be suggested from
physician or doctor‟s advice.
2. Base on individual body condition the typical operation time takes
approximately 30 seconds to 1 minute.

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Hypertension Indicator
This unit features our unique Hypertension Indicator. The World Health
Organization has established globally accepted standards for the
assessment of high or low blood pressure readings. The below chart
should be considered only as a guideline, always consult with your
physician or health care professional to interpret your individual results.

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Irregular Heartbeat Detector
Your digital blood pressure monitor features an Irregular Heartbeat
Detector. This feature allows users to accurately monitor blood pressure
even if an irregular heartbeat should occur. When an irregular heartbeat
“ ”is detected, the icon will appear on the display.
Note:
Please consult with your physician or trained healthcare professional for
further information regarding an irregular heartbeat and if this symbol
appears frequently.
INPORTANT INFORMATION:
This blood pressure monitor is not designed for use by people with
arrhythmias nor for diagnosing or treating an arrhythmia problem. As a
safeguard, we recommend that if you have arrhythmias such as atrial or
ventricular premature beats and atrial fibrillation or any other special
conditions you should check with your physician before using your
blood pressure monitor.

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Atrial Fibrillation (AFIB)
This device is a blood pressure monitor that also analyses heart rate
variability during measurement.
While in power off mode, switch the “AF” key to select AF mode “ON”
or “OFF”. After measurement mode setting, press the “SET” key to
select user. Confirm your selection with the Power key to turn the power
on and start to measure your blood pressure. Or wait for 3 seconds,
your selection is then stored and shut off automatically.
This feature allows users to accurately monitor blood pressure even if
atrial fibrillation should occur. When atrial fibrillation is detected, the
“ ”icon will appear on the display.
Note:
1. Please consult with your physician or trained healthcare professional
for further information regarding an atrial fibrillation if this symbol
appears frequently.
2. Even if the AF symbol does not appear, there is still a possibility of
Afib.

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Memory Function
Recalling Measurements in Memory:
You can recall up to 100 measurements for each user, plus those
average values stored measurements in memory to share with your
physician or trained healthcare professional.
If you press the M key, the unit will first display the average of last 3
currently stored measurements. Continue to press the M key to
successively view the average value of the morning measurements and
evening measurements for the last 7 days will be displayed.
The duration of morning is AM5:00 –AM9:00,
The duration of evening is PM6:00 –PM8:00
If you press the M key again, the measurements will appear on the
display from most current to oldest. And the memory number will
appear on the display.
All results for a given measurement will display, including measurement
results, pulse rate, Hypertension Indicator, Irregular Heartbeat alert, and
date/time stamp.
When the number of readings exceeds 100, the oldest data will be
replaced with the new record.
Press the Power key to turn the unit off at any time when you check the

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stored measurements
Clearing Measurements from Memory:
From the memory mode, press and hold down the M key until the
display shows CLr. This indicates that all measurements have been
erased.