Wellue BP2 User manual

Automatic Upper Arm
Blood Pressure Monitor
User Manual
Model BP2/BP2A

Table of Contents
1. The Basics.................................................................. 1
1.1 Safety............................................................. 1
2. Introduction...............................................................5
2.1 Intended Use..................................................5
2.2 Contraindications........................................... 5
2.3 About the Product......................................... 6
2.4 Symbols.......................................................... 7
3. Using the Monitor..................................................... 8
3.1 Charge the Battery......................................... 8
3.2 Blood Pressure Measurement....................... 8
3.2.1 Before Taking a Measurement..............8
3.2.2 Applying the Arm Cuff.......................... 8
3.2.3 How to Sit Correctly..............................9
3.2.4 Measuring Blood Pressure....................9
3.2.5 After Measurement............................ 10
3.3 Recording ECG..............................................10
3.3.1 Before Taking a Measurement........... 10
3.3.2. Recording ECG without Cable............ 11
3.3.3. Turn on/off Heartbeat Sound............ 12
3.4 Review History Record................................. 12
3.5 Turning On/Off Bluetooth............................13
4. Troubleshooting...................................................... 13
5. Accessories.............................................................. 14
6. Maintenance........................................................... 15
6.1 Maintenance................................................15
6.2 Cleaning....................................................... 15
6.3 Storage.........................................................15
7. Specifications.......................................................... 16
8. Electromagnetic Compatibility................................18

1
1. The Basics
This manual contains the instructions necessary to
operate the product safely and in accordance with its
function and intended use. Observance of this manual
is a prerequisite for proper product performance and
correct operation and ensures patient and operator
safety.
1.1 Safety
Warnings and Cautionary Advices
Before using the device, please ensure that you have
read this manual thoroughly and fully understand
corresponding precautions and risks.
This device has been designed for practical use, but is not
a substitute for a visit to the doctor.
The data and results displayed on the device are for
reference only and cannot be directly used for diagnostic
interpretation or treatment.
We recommend not to use this device if you have a
pacemaker or other implanted devices. Follow the advice
given by your doctor, if applicable.
Do not use this device with a defibrillator.
Do not use this device during MRI examination.
Do not use the device in a combustible environment (i.e.,
oxygen-enriched environment).
Never submerge the device in water or other liquids. Do
not clean the device with acetone or other volatile
solutions.
Do not drop this device or subject it to strong impact.
Do not place this device in pressure vessels or gas
sterilization device.
Do not dismantle the device, as this could cause damage

2
or malfunctions or impede the operation of the device.
This device is not intended for use by people (including
children) with restricted physical, sensory or mental skills
or a lack of experience and/or a lack of knowledge,
unless they are supervised by a person who has
responsibility for their safety or they receive instructions
from this person on how to use the device. Children
should be supervised around the device to ensure they
do not play with it.
Do not allow the electrodes of the device to come into
contact with other conductive parts (including earth).
Do not use the device with persons with sensitive skin or
allergies.
Do not store the device in the following locations:
locations in which the device is exposed to direct sunlight,
high temperatures or levels of moisture, or heavy
contamination; locations near to sources of water or fire;
or locations that are subject to strong electromagnetic
influences.
Do not swing the device with the strip, which may result
in injury.
This device displays changes in the heart rhythm and
blood oxygenation etc. which may have various different
causes. These may be harmless, but may also be
triggered by illnesses or diseases of differing degree of
severity. Please consult a medical specialist if you believe
you may have an illness or disease.
Vital signs measurements, such as those taken with this
device, cannot identify all diseases. Regardless of the
measurement taken using this device, you should consult
your doctor immediately if you experience symptoms
that could indicate acute disease.
Do not self-diagnose or self-medicate on the basis of this
device without consulting your doctor. In particular, do
not start taking any new medication or change the type

3
and/or dosage of any existing medication without prior
approval.
This device is not a substitute for a medical examination
or your heart or other organ function, or for medical
electrocardiogram recordings, which require more
complex measurements.
It is not possible to use this device to diagnose illness or
diseases. This is exclusively the responsibility of your
doctor.
We recommend that you record the ECG curves and
other measurements and provide them to your doctor if
required.
Clean the device and cuff with a dry, soft cloth or a cloth
dampened with water and a neutral detergent. Never
use alcohol, benzene, thinner or other harsh chemicals to
clean the device or cuff.
Avoid tightly folding the cuff or storing the hose tightly
twisted for long periods, as such treatment may shorten
the life of the components.
The device and cuff are not water-resistant. Prevent rain,
sweat and water from soiling the device and cuff.
Measurements may be distorted if the device is used
close to television, microwave oven, cellular telephone,
X-ray or other devices with strong electrical fields.
Do not modify the device. It may cause accidents or
damage to the device.
To measure blood pressure, the arm must be squeezed
by the cuff hard enough to temporarily stop blood flow
through the artery. This may cause pain, numbness or a
temporary red mark to the arm. This condition will
appear especially when measurement is repeated
successively. Any pain, numbness, or red marks will
disappear with time.
Do not apply the cuff on an arm with another medical
electrical equipment attached. The equipment may not

4
function properly.
People who have a severe circulatory deficit in the arm
must consult a doctor before using the device, to avoid
medical problems.
Do not self-diagnose the measurement results and start
treatment by yourself. Always consult your doctor for
evaluation of the results and treatment.
Do not apply the cuff on an arm with an unhealed
wound.
Do not apply the cuff on an arm receiving an intravenous
drip or blood transfusion. It may cause injury or
accidents.
Do not use the device where flammable gases such as
anesthetic gases are present. It may cause an explosion.
Do not use the device in highly concentrated oxygen
environments, such as a high-pressure oxygen chamber
or an oxygen tent. It may cause a fire or explosion.

5
2. Introduction
2.1 Intended Use
The product is intended to be used for measuring,
displaying, reviewing and storing of ECG and blood
pressure variation in home or healthcare facilities
environment.
ECG and Blood pressure variation is intended for use
with adult.
The data and results provided by this device are for
pre-check screening purpose only and cannot be
directly used for diagnostic or treatment.
Product Features
Model
Blood Pressure
Measurement
ECG
Measurement
BP2
√
√
BP2A
√
2.2 Contraindications
This device is contraindicated for use in ambulatory
environments.
This device is contraindicated for use on aircraft.

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2.3 About the Product
1. Start/Stop button
Power On/Off
Press to Start/Stop blood pressure measurement.
2. Function button
Press to Start ECG measurement.
Press and hold 2 seconds to review historical data.
3. Display screen
4. LED indicator
Blue light is on: the battery is charging.
Blue light is off: the battery is full charged.
5. ECG electrode
Press and hold them during the ECG measurement.
6. Cable connector
Connect with the charging cable.

7
2.4 Symbols
Symbol
Description
Application part type BF
Manufacturer
CE0197
In conformity with Directive 93/42/EEC
European Representative
Symbol for “ENVIRONMENT PROTECTION
–Waste electrical products should not
be disposed of with household waste.
Please recycle where facilities exist.
Check with your local authority or
retailer for recycling advice”.
IP22
Against ingress of solid foreign objects
≥12.5mm diameter, Against dripping(15°
tilted)
Follow operating instructions
Heartbeat symbol
Battery symbol
Bluetooth symbol
Data transmission symbol
ECG waveform
ECG measurement progress bar

8
3. Using the Monitor
3.1 Charge the Battery
Use the USB cable to charge the monitor. Connect the
USB cable to a USB charger or to the PC. A fully charge
will need 2 hours. When the battery charged fully the
indicator will be blue.
The monitor works in a very low power consumption
and a full charge usually works for months. A battery
symbols which indicate the battery status is displayed
on the screen.
Note: The device cannot be used during charging.
3.2 Blood Pressure Measurement
3.2.1 Before Taking a Measurement
To help ensure an accurate measurement, follow these
directions:
Rest for at least 5 minutes before taking the
measurement.
Stress raises blood pressure. Avoid taking measurements
during stressful times.
Remove tight-fitting clothing from your arm.
A single measurement does not provide an accurate
indication of your true blood pressure. You need to take
and record several results over a period of time.
Try to measure your blood pressure at the same time
each day for consistency.
3.2.2 Applying the Arm Cuff
1. Wrap the cuff around the upper arm, about 1 to 2
cm above the inside of the elbow, as shown.
2. Place the cuff directly against the skin, as clothing

9
may cause a faint pulse and result in a
measurement error.
3. Constriction of the upper arm, caused by rolling
up shirtsleeve, may prevent accurate readings.
4. Confirm that the artery position mark is line up
with the artery.
3.2.3 How to Sit Correctly
To take a measurement, you need to be relaxed and
comfortably seated. Sit in a chair with your legs
uncrossed and your feet flat on the floor. Place your
arm on a table so the cuff is level with your heart.
3.2.4 Measuring Blood Pressure
1. Power on the blood pressure monitor.
2. Press Start/Stop button to start blood pressure
measurement.
3. The monitor will automatically deflate the cuff
slowly during measurement, a typical

10
measurement takes about 30s.
4. The readings will be displayed when the
measurement finished.
You can press Start/Stop button again to stop the
blood pressure measurement.
Note: During measurement, you should keep still and
do not squeeze the cuff.
3.2.5 After Measurement
The monitor will automatically release the cuff gas
after the measurement is over.
Press the button to turn off the power after the
measurement. Remove the cuff.
Note: The device has an automatic power shut-off
function, which turns off the power automatically in
one minute after measurement.
3.3 Recording ECG
3.3.1 Before Taking a Measurement
To help ensure an accurate measurement, follow these
directions:
Before using ECG function, pay attention to the
following points in order to obtain precise
measurements.
The ECG electrode must be positioned directly against
the skin.
If your skin or hands are dry, moisten them using a damp
cloth before taking the measurement.
If the ECG electrodes are dirty, remove the dirt using a
soft cloth or cotton bud dampened with disinfectant
alcohol.
During the measurement, do not touch your body with

11
the hand with which you are taking the measurement.
Please note that there must be no skin contact between
your right and left hand. Otherwise, the measurement
cannot be taken correctly.
Stay still during the measurement, do not speak and hold
the device still. Movements of any kind will falsify the
measurements.
If possible, take the measurement when sitting and not
when standing.
Follow the text and voice guide on the phone to finish
the measurement.
3.3.2. Recording ECG without Cable
There are four methods for recording ECG by cablefree
measurement.
A.Right hand to left Leg B.Hand to hand
C.Right hand to abdomen D.Right hand to chest

12
To start an ECG Recording:
1. Put your right palm on the right side electrodes of the
Monitor.
2. Put the left side electrodes to the body position that you
desired to measure.
3. Once the body parts are placed on the electrodes, press
Function button to start the EKG recording.
4. Wait for 30 seconds, the result readings will be displayed.
To start recording ECG again, press Start/Stop button to
return Home screen, then press Function button.
Note:
The recording must be at least 30 seconds to complete,
and to be analyzed by the detectors
You can get different signal amplitude from the different
methods. Usually, the signal from method A (Right hand
to left leg) is stronger.
3.3.3. Turn on/off Heartbeat Sound
The buzzer beep when heartbeat is detected during
ECG recording. You can turn on/off the heartbeat
sound on the App.
3.4 Review History Record
You can review the history results and replay the recorded
ECG waveform in History screen.
Hold Function button 2 seconds to enter History screen. The
last measurement result will be displayed in default
For ECG recording, the Heart Rate will be displayed first and
then replayed the 30-second ECG waveform.
To view next record, press NEXT button.
To exit History screen, press HOME button.

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3.5 Turning On/Off Bluetooth
Monitor has built-in Bluetooth wireless connectivity,
which enables exporting measured records to mobile
phones and pads running iOS or Android platform.
Press the function button and hold it for 3 seconds to
start Bluetooth mode.
Data can only be exported in Bluetooth mode. Pressing
the Start/Stop button will exit Bluetooth mode.
4. Troubleshooting
Problem
Possible Cause
Solution
No power.
No display
appears on the
device.
Battery is depleted
Recharge the
battery
Blood pressure
readings
appear too
high or too low
Blood pressure
varies constantly.
Many factors
including stress,
time of day, and/or
how you apply the
arm cuff, may
affect your blood
pressure.
Hold still for a
moment and
try again
Error 1
Apply the arm
cuff tighter.
Arm cuff is applied
too loosely
Apply the arm
cuff tighter and
try again.
Error 2
Do not move or
talk remain
still.
You move or talk
during a
measurement and
the pressure of
cuff is interfered
Remain still and
do not talk
during a
measurement

14
seriously.
Error 3
Remove any
clothing
interfering with
the cuff.
The signal is poor
during blood
pressure
measurement.
Take blood
pressure on a
bare arm.
Error x (x>4)
Contact
customer
service.
The device has
malfunctioned.
contact
customer
service.
Check connect
The ECG cable is
off, or the body
parts are not place
on the electrodes
closely.
Check the ECG
cable, or place
the electrodes
close to your
body part.
ECG waveform
drifts
The pressure
exerted on the
electrode is not
stable or too
much.
Hold the device
stably and
gently.
Hand or body may
be moving.
Try to keep
perfectly still
and test again.
The ECG
waveform
amplitude is
small
The measurement
method you
choose is not
suitable for you.
Change another
lead and try
again.
5. Accessories
Model
Description
540-00240-00
MICRO USB charge cable

15
6. Maintenance
6.1 Maintenance
To protect your monitor from damage, store the monitor and
the components in a clean, safe location.
Caution: DO NOT disassemble or attempt to repair this
monitor or other components. This may cause an inaccurate
blood pressure readings and/or EKG recordings.
6.2 Cleaning
Do not use any abrasive or volatile cleaners.
Use a soft dry cloth or a soft cloth moistened with mild
(neutral) detergent to clean your monitor and the arm
cuff and then wipe them with a dry cloth.
When electrodes are dirty, use a soft cloth or cotton
swab moistened with alcohol-based sanitizer to clean the
electrodes.
Do not use gasoline, thinners or similar solvents to clean
your monitor and arm cuff or other components.
6.3 Storage
Keep your monitor and other components in the storage
case when not in use.
Store your monitor and other components in a clean,
safe location.
Do not store your monitor and other components in
locations exposed to extreme temperatures, humidity,
direct sunlight, dust or corrosive vapors such as bleach.

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7. Specifications
Classifications
EC Directive
MDD, 93/42/EEC
RED, 2014/53/EU
ROHS 2.0, 2011/65/EU
Degree protection
against electrical shock
Type BF
Environmental
Item
Operating
Storage
Temperature
5 to 40°C
-25 to 70°C
Relative humidity
(non-condensing)
10% to 95%
10% to 95%
Barometric
700 to 1060 hPa
700 to 1060 hPa
Degree of dust & water
resistance
IP22
Drop test
1.0 m
Physical
Size (main unit)
135mm(long)×45mm(W)×20mm(H)
Weight (main unit)
240 g
Cuff size
Adult cuff: 22-42cm
Small adult cuff (optional): 17-22cm
Adult cuff(optional): 22-32cm
Wireless connectivity
Built-in Bluetooth 4.0 BLE
Power Supply
Charge input
Micro USB, DC5V

17
Battery type
Rechargeable lithium-polymer
battery
Battery run time
500 measurements
Charge time
2 hours
Blood Pressure Measurement
Technology
Oscillometric Method
Pressure measurement
range
0–300mmHg
Pressure measurement
accuracy
±3mmHg
Pulse rate range
40 to 200 /min
Pulse rate accuracy
±2 /min
Clinical accuracy
Meet IEC80601-2-30
ECG Recording
Lead type
Integrated ECG electrodes
Lead set
Lead I, lead II, Chest Lead
ECG length
30s
Heart rate range
30 - 250/min
Heart rate accuracy
±2 /min or ±2%,
whichever is greater
Storage
Blood pressure records
50
ECG records
10
Bluetooth RF
Frequency range
2.402 –2.480 GHz
Max RF power
-10 dBm

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8. Electromagnetic Compatibility
The device meets the requirements of EN 60601-1-2.
Warnings and Cautionary Advices
Using accessories other than those specified in this
manual may result in increased electromagnetic emission
or decreased electromagnetic immunity of the
equipment.
The device or its components should not be used
adjacent to or stacked with other equipment.
The device needs special precautions regarding EMC and
needs to be installed and put into service according to
the EMC information provided below.
Other devices may interfere with this device even though
they meet the requirements of CISPR.
When the inputted signal is below the minimum
amplitude provided in technical specifications, erroneous
measurements could result.
Portable and mobile communication equipment may
affect the performance of this device.
Other devices that have RF transmitter or source may
affect this device (e.g. cell phones, PDAs, and PCs with
wireless function).
Guidance and Declaration - Electromagnetic Emissions
The Health Monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the
device should assure that it is used in such an environment.
Emission tests
Compliance
Electromagnetic environment
- guidance
RF emissions
CISPR 11
Group 1
The device uses RF energy
only for its internal function.
Therefore, its RF emissions
are very low and are not likely