Wellex BPM83 User manual

Arm Type Blood Pressure Monitor
Model: BPM83
INSTRUCTION MANUAL
Please read this instruction manual carefully
before operating this unit.

Contents
Intended Use 3
Important Information before Use 4
Product Identication 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
World Health Organization (WHO) 14
Irregular Heartbeat Detector 14
Atrial Fibrillation (AFIB) 15
Memory Function 16
Error Codes 17
Troubleshooting 18
Care and Maintenance 19
Applied Standards 20
Technical Specication 21
EMC Tables 22
Explanation of Symbols 23

Intended Use
The BPM83 Series automatically measures human begins 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 arm. The intended use of this over-the-
counter device is for adults with arm circumference ranging from
220 mm to 420 mm (Approx. 8.7 ~ 16.6 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.
3

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 cu󰀨 placement.
6. Keep the monitor stable during measurement to achieve
an accurate reading. Remain still; do not talk during the
measurement.
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 ination or deation process of
the cu󰀨 at any time by pressing the POWER button.
4

Important Information Before Use
For Customer Service, It is recommended that the accuracy should
be checked by manufacture every 1 years. To obtain the service
please contact AViTA Corp. for the address of the repair location.
Enclose the Proof of Purchase. Include $10.00 USD for the return
shipping and handling. Include a letter, with your name, address,
phone number, and description of the specic problem. Pack the
product carefully to prevent damage in transit. Because of possible
loss in transit, we recommend insuring the product with return
receipt requested. If in need of assistance of setting up, using,
maintaining or to report unexpected operation/events please contact
manufacturer or local representative for further information and
assistance. Avoid the sensor degrading, it is needed calibrate the
device every 1 year.
• Clinical accuracy and the protocols for investigating the clinical
accuracy meet ISO 81060-2:2013.
• Do not use in this case. (e.g. Device for use in an ambulance or
helicopter, For use in the professional environment.)
• This product is suitable for use in the home healthcare
environment.
• The performance of the device can be a󰀨ected by extremes
of temperature, humidity and altitude, Please refer to the
instructions for use.
CAUTION:
Keep this device out of the reach of children. Strangulation resulting
from baby or child entanglement in cables.
Please keep this device away from pets, pests, and children.
Avoid potential allergic reactions, please avoid the device in direct
contact to patient's wound.
• WARNING: No modification of this equipment is allowed.
5

Product Identification
1
2
11 103
4
5
6
7
8
9
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. Cu󰀨
8. Cu󰀨 connector
9. Cu󰀨 tube
10 Atrial Fibrillation Detection (AFIB) model (Optional)
11 USB Type C Socket (Optional)
6

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
7

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 4 x 1.5 V AA A alkaline 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.
AC Power Adapter(NOT Incuded)
Type:
Input:AC 100~240V 50/60HZ
Output:DC5V 1.0A
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.
8

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 o󰀨 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 ash.
• Press the “SET” key to advance the display to the desired year,
press the “M” key to conrm 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 o󰀨.
M Key
Press Set key
Press Set key
Press Set key
Press Set key
Press Set key
Load
Batteries
M Key M Key M Key
Year
Hour Minute
Month Date
M Key
9

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 cu󰀨 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 cu󰀨 placement.
2. Be seated at a table or desk with your feet at on the oor.
3. The cu󰀨 should not be plugged into the monitor until after the cu󰀨
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 cu󰀨 on a solid surface with the
tubing facing up and away from you. The
metal ring/bar on the cu󰀨 should be to the
left of the tubing.
5. Open the cu󰀨 by pulling or rolling the bottom
of the cu󰀨 to the right. This should open the
10

Placement of the Pressure Sleeve
cu󰀨 without fully unrolling it, creating
a cylinder. Do not fully unwrap or
unroll the cu󰀨.
6. Insert your left arm into the created
cu󰀨 cylinder. Position the ( ) mark
over the main artery on the inside of
your arm.
7. The bottom edge of the cu󰀨 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 cu󰀨 towards your body to tighten
the cu󰀨. Wrap and secure the cu󰀨,
making sure that the ( ) mark
remains in place as shown.
9. The cu󰀨 should t comfortably, yet snugly around your arm. You
should be able to insert one nger easily between your arm and
Note:
If you are not comfortable with applying your cu󰀨, please seek
the assistance of another member of your household or work
with your physician to practice the cu󰀨 application. Incorrectly
applied cu󰀨s may result in inaccurate readings.
11

SET
Key
Measurement of Pulse Rate and Blood Pressure
To set the user and memory zone, proceed as follows:
While in power o󰀨 mode, press the “SET” key to select user.
Conrm 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 o󰀨 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 cu󰀨 will automatically
begin to inate, with the display showing the
increasing pressure in the cu󰀨.
3. As the pressure increases, the indicator will
increase upwards according to the pressure
value on the display.
4. As the cu󰀨 inates, the monitor automatically
determines your ideal ination level. This monitor
detects your blood pressure and pulse rate
during ination.
12

Measurement of Pulse Rate and Blood Pressure
5. To detect the heartbeat, the heartbeat symbol
will appear and continuous ashes 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 o󰀨 and
conserve energy and battery life.
The unit will automatically shut-o󰀨 approximately
2 minutes.
13

High-Normal
World Health Organization (WHO)
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.
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 atrial
brillation and if this symbol appears frequently.
14

Atrial Fibrillation (AFIB)
This device is a blood pressure monitor that also analyses
heart rate variability during measurement.
While in power o󰀨 mode, switch the “AF” key to select AF mode “ON”
or “OFF”. After measurement mode setting, press the “SET” key to
select user. Conrm 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 o󰀨 automatically.
This feature allows users to accurately monitor blood pressure even
if atrial brillation should occur. When atrial brillation
is detected, the “ ”icon will appear on the display.
Note:
Please consult with your physician or trained healthcare
professional for further information regarding an atrial
brillation and if this symbol appears frequently.
15

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 rst
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 o󰀨 at any time when you check
the stored measurements
16

Memory Function
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.
Error Codes
Err
Code Meaning Corrective Action
Err 00 No pulse or detect
pulses not enough.
Take o󰀨 heavy clothes and retry
again.
Err 01 The cu󰀨 is not
fastened correctly
The Arm cu󰀨 is not fastened
properly. Re- apply the cu󰀨, and
take a measurement again.
Err 02 Inaccurate reading Rest a while, relax and retry again.
Err 03
Ination or deation
fail during the
measurement
The Arm cu󰀨 is not fastened
properly. Re- apply the cu󰀨, and
take a measurement again.
Err Memory error.
Take o󰀨 batteries to reboot
the device, then take another
measurement.
Low batteries Replace all batteries with new ones.
17

Troubleshooting
Problem Probable Cause Recommended Action
Nothing
appears in
the display
even when
the power is
turned on.
Batteries are drained. Replace all batteries with new
ones.
Battery are not correctly aligned
with terminals. Reinsert batteries in the correct position.
Low Battery
Symbol
appears.
Batteries are drained. Replace all batteries with new
ones.
In colder temperatures batteries
have weaker electrical charges.
Warm up the batteries, or
use the device in a warmer
setting.
Device
operation time
is inconsistent.
Di󰀨erent battery brands have
di󰀨erent life spans.
Use Alkaline batteries and
replace all batteries at the
same time with same brand
batteries.
No reading
after
measurement. Batteries are drained. Replace all batteries with new
ones.
Suspicious
blood pressure
results.
Perhaps the cu󰀨 was improperly
positioned. Adjust patient and arm cu󰀨 to measure.
Blood pressure naturally varies
throughout the day. Rest a while, relax and measure again.
Suspicious
heart rate
results.
Bodily movement during device
use. Refrain from moving during measurement.
Measurement shortly after
exercise or exposure to the
outdoors.
Do not take measurements
after exercise or coming back
from the outdoors.
Power
switches o󰀨
automatically. System design. Push the power button again,
and then begin measure
again.
During
measuring, air
re-inates.
It could be a normal action if
the user's blood pressure is
higher than the initial pressure
value, the device automatically
pumps to a higher pressure by
40mmHg each time.
Relax, and try to take a
measure again.
The arm cu󰀨 is not fastened
properly.
Check that the arm cu󰀨 is
fastened properly and retake
the measurement.
18

Care and Maintenance
• Clean your blood pressure monitor carefully using a slightly
damp cloth only.
• Do not use any detergents or solvents.
• Never hold the instrument under water as otherwise liquid can
penetrate and damage the instrument
• Never place any heavy objects on the instrument. Please note:
For home use device disinfection, 75% Ethanol or Isopropyl
alcohol(available in the phWristacy) can be used. receipt
requested.
We provide a 2-year warranty covering faults in materials or
manufacture of the product from the purchase date. The warranty
does not cover:
• Damage resulting from improper use.
• Wear parts.
• Defects that were known to the customer at the time of
purchase.
• Damage for which the customer was responsible.
This warranty does not a󰀨ect the customer’s legal rights. The
customer must provide proof of purchase in order for any warranty
claims within the warranty period to be honoured. Claims under
the warranty within a period of 2 years from the date of purchase
are honoured by MDSS GmbH., Schi󰀨graben 41, 30175 Hannover,
Germany.
In the event of a warranty claim, the customer has the right to have
the goods repaired by our own work- shop or a workshop authorized
by use. The device must not be opened for any reason. Opening or
modifying the device invalidates the warranty. This warranty does
not grant any additional rights to the customer.
19

Care and Maintenance
Applied Standards
Please note: It is recommended that the accuracy should be
checked by manufacture every 1 years. To obtain the service please
contact AViTA Corp. for the address of the repair location. Enclose
the Proof of Purchase. Include $10.00 USD for the return shipping
and handling. Include a letter, with your name, address, phone
number, and description of the specic problem. Pack the product
carefully to prevent damage in transit. Because of possible loss
in transit, we recommend insuring the product with return receipt
requested.
• This unit is in line with European Standard EN 60601-1-2 and is
subject to particular precautions with regard to electromagnetic
compatibility (EMC). Please note that portable and mobile HF
communication systems may interfere with this unit. More details
can be requested from the stated Customer Service address or
found at the end of the instructions for use.
• This device is in line with the EU Medical Devices Directive
93/42/ EC, the “Medizinproduktegesetz” (German
Medical Devices Act) and EN 1060-3 (non-invasive
sphygmomanometers, Part 3: Supplementary requirements for
electro-mechanical blood pressure measuring systems) and
IEC 80601-2-30 (Medical electrical equipment – Part 2 – 30:
Particular requirements for the safety and essential performance
of automated non-invasive blood pressure monitors).
• The accuracy of this blood pressure monitor has been carefully
checked and developed with regard to a long useful life. If using
the device for commercial medical purposes, it must be regularly
tested for accuracy by appropriate means. Precise instructions
for checking accuracy may be requested from the service
address.
20