Viatom Wellue AirBP 2 User manual

AirBP 2
Blood Pressure Monitor
User Manual (EN)
Benutzerhandbuch (DE)
Manuale d'uso (IT)
Manual de usuario (ES)
Manuel de l'utilisateur (FR)

Contents
User Manual…….…............…..........English 1-16
Benutzerhandbuch...........….............Deutsch 17-35
Manuale d'uso........…..…....…..........Italiano 36-54
Manual de usuario…………..............Español 54-71
Manuel de l'utilisateur.........…...........Français 72-89

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User Manual
Contents
1. The Basics........................................................... 2
2. Introduction.......................................................... 4
2.1 Device Description..................................... 4
2.2 Intended Use ............................................. 5
2.3 Contraindications....................................... 5
2.4 Symbols..................................................... 5
3. Using the Monitor ................................................ 6
3.1 Charging the Battery.................................. 6
3.2 Beep indications ........................................ 7
3.3 Applying the Arm Cuff................................ 7
3.4 How to Sit Correctly................................... 8
3.5 Connect to the App.................................... 8
3.6 Measurement............................................. 9
3.7 After the Test............................................. 9
3.8 Reviewing the History.............................. 10
3.9 Measurement without App....................... 11
3.10 Trouble Shooting ................................... 11
4. Accessories ....................................................... 12
5. Specifications .................................................... 12
6. Maintenance...................................................... 14
6.1 Maintenance............................................ 14
6.2 Cleaning .................................................. 14
6.3 Storage.................................................... 15
7. Electromagnetic Compatibility ........................... 15

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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, correct operation, and ensures
patient and operator safety.
Safety
Precision components are used in the
construction of this device. Extremes in
temperature, humidity, direct sunlight, shock
or dust should be avoided.
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.
Do not use in a location with moisture, or a
location where water may splash on the
device. This may damage the device.
Do not disassemble or attempt to repair the
monitor or components. This may cause an
inaccurate reading.
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

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temporary red mark to the arm. This condition
will appear especially when measurement is
repeated successively.
Stop using this monitor and consult your
physician if you experience skin irritation or
discomfort.
Consult your physician before using this
monitor on an arm with an arterio-venous (A-V)
shunt.
Consult your physician before using this
monitor if you have had a mastectomy or
lymph node clearance.
Consult your physician before using the
monitor if you have severe blood flow
problems or blood disorders as cuff inflation
can cause bruising.
People who have a severe circulatory deficit
in the arm must consult a physician before
using the device, to avoid medical problems.
Do not self-diagnose the measurement results
and start treatment by yourself. Always
consult your physician for evaluation of the
results and treatment.
Do not apply the cuff on the injured arm or the
arm under medical treatment.
Do not use the device with other medical
electrical (ME) equipment simultaneously.
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 the area of HF
surgical equipment, MRI, or CT scanner, or in
an oxygen rich environment.

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Use only the approved arm cuff for this device.
Use of other arm cuffs may result in incorrect
measurement results.
Rest for at least 5 minutes before taking the
measurement.
Remove tight-fitting or thick clothing from your
arm while taking a measurement.
Remain still and do not talk while taking a
measurement.
If the patients’arm is outside the specified
circumference range (22-42cm) that may
result in incorrect measurement results.
The device is not intended for use with
neonatal, pregnant, including pre-eclamptic,
patients.
When choosing a third-party charging adaptor,
select one that complies with IEC 60950 or
IEC 60601-1.
Dispose of the device, components and
optional accessories according to applicable
local regulations. Unlawful disposal may
cause environmental pollution.
2. Introduction
2.1 Device Description
The blood pressure monitor includes two models,
BP1 and BP1A. It uses the oscillometric method to
measure blood pressure with Bluetooth technology.
The monitor is comprised of a cuff, a main unit, a
rubber hand-pump, an exhaust valve and an air
hose. The blood pressure data is displayed, stored
and reviewed including the systolic and diastolic

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blood pressure, as well as pulse rate in an
application which is installed on a smart phone.
2.2 Intended Use
The subject device is intended to measure diastolic
and systolic blood pressure, as well as pulse rate of
the adult population in home and hospital facilities
by using a non-invasive, oscillometric technique
with a single upper arm cuff (22-42 cm).
2.3 Contraindications
The use of this device is prohibited in
ambulatory environments.
The use of this device is prohibited on aircraft.
2.4 Symbols
Symbol Description
Manufacturer
Date of manufacture
SN Serial number
Indicates a medical device that is not to
be disposed of as unsorted municipal
waste.
Follow Instructions for Use.
Type BF Applied Part
No alarm system

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MRI unsafe. Presents hazards in all MR
environments as device contains
strongly ferromagnetic materials.
IP22 Resistant to liquid ingress
CE marking
Authorized representative in the
European community
UKCA marking
Authorized Representative in the United
Kingdom
This product complies with the rules and
regulations of the Federal
Communication Commission.
3. Using the Monitor
Download the App AirBP
iOS: App Store
Android: Google Play
Note: if you’ve downloaded the App before, please update
to the latest version.
3.1 Charging the Battery
Charge the monitor by using the USB cable to
connect a USB charger or to the PC USB Port. It

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takes 2 hours to fully charge the monitor
In the App, you can check the battery level.
Note: The device cannot be used while charging.
3.2 Beep indications
two short beeps Stop pumping
One long beep End of measurement
Three short beeps
Pump pressure is too high
(above 300mmHg)
3.3 Applying the Arm Cuff
Wrap the cuff around the upper arm, about 1 to
2cm above the inside of the elbow, as shown.
Place the cuff directly against the skin, as
clothing may cause a faint pulse and result in a
measurement error.
Constriction of the upper arm, caused by
Do not roll up shirtsleeve too tightly
Artery position mark

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rolling up a shirtsleeve, may prevent accurate
readings.
Confirm that the artery position mark is lined
up with the artery.
3.4 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. Sit with
both your back and arm being supported. Place
your arm on a table so the cuff is level with your
heart.
3.5 Connect to the App
1. Turn on the Phone’s Bluetooth.
2. Press the button to power on the monitor.
3. Open the Air BP APP on your smartphone.
The App will search for the device. Choose
your device "AirBP xxxx" in the App.
Note:
Keep the monitor and the phone within 1.5 meters of
each other.

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DO NOT pair in your phone settings.
The APP can be downloaded in Google Play or APP
Store with the name "AirBP", which requires a
smartphone.
3.6 Measurement
Make sure your phone speakers are turned on and
the volume is loud enough. Follow the text and
voice guide in the App to use.
In App->Measure,
Follow the instructions to inflate the cuff by
squeezing the pump at the rate indicated in
the App.
Stop pumping according to instructions of
the App, hold the pump without squeezing it,
and wait for the further instructions. In some
cases, if the App senses that the pressure in
the cuff is not high enough for use, then the
user will be instructed to "pump again".
Note: During use you should keep your body still.
Otherwise, the blood pressure readings may be
inaccurate.
Stop pumping when the screen of the monitor show “Out
of Rang” and beep 3 short beeps (pressure is too high).
3.7 After the Test
The blood pressure readings will
appear on the App interface when
the test has finished. You need to
manually press the exhaust valve

1
to deflate the cuff. If you forget to deflate the
cuff manually after use, the monitor will
automatically deflate the cuff, which takes less
than 30s for full automatic deflation.
On the results page, you can add user names
and ID’s to help you manage multiple users
data, add notes, share results or delete them.
If the monitor detects an irregular heartbeat,
then the corresponding symbol will display
below the PR value.
Note: The device will turn off automatically after two
minutes if not working.
3.8 Reviewing the History

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3.9 Measurement without App
After you have learned how to use the App for
measurement. You can also perform measurement
without connecting to the app when you do not
need to store data.
1. Refer to section 3.3 and 3.4 to wear the cuff.
2. Inflate the cuff by squeezing the pump at the
similar rate you have learned in the App.
3. Stop pumping when the monitor beep twice,
hold the pump without squeezing it, and wait
for the further instructions. In some cases, if
the monitor senses that the pressure in the cuff
is not high enough for use, then the user will
be instructed to "Pump" again.
4. After the test. The blood pressure readings
will appear on the screen of the monitor when
the test has finished. You need to manually
press the exhaust valve to deflate the cuff.
Note:
If you want to start a new measurement, you can
short press the power button of the monitor. Or pump
When the monitor is not connected to App for
measurement, the results will not be saved.
3.10 Trouble Shooting
Problem Possible Cause
Recommended
Action

1
The monitor
cannot be
connected to
the phone
The phone
Bluetooth is OFF
Turn on the
phone Bluetooth
in the settings
menu.
The phone doesn’t
support the
Bluetooth 4.0 BLE
Change to a
compatible
phone.
The monitor
doesn’t
respond when
pressing the
button.
The monitor is
running in an
unexpected status.
Reset the device
by pressing and
holding the
button for 5s.
Cannot get
blood
pressure
readings.
The measurement
is interrupted by
arm movement or
unexpected bulb
squeezing during
use
Keep the arm
still and don’t
squeeze the bulb
during deflation.
There is pressure
leakage.
Check the hose
connection to
see if it is loose.
4. Accessories
Model
Description
CU-10
Adult, arm size 22-42cm
540-00240-00
MICRO USB charger cable
Arm size: The circumference at the biceps.
5. Specifications
Classifications

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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
Physical
Size
68mm(long)×25mm(diameter
) (main unit)
Weight
Less than 30 g (main unit)
Cuff size
Adult cuff: 22-42cm
Wireless connectivity
Built-in Bluetooth 4.0 BLE
Power Supply
Charger input
Micro USB, DC5V
Battery type
Rechargeable
lithium-polymer battery
Estimated charging time Approximately 2 hours
Blood Pressure
Technology
Oscillometric method
Cuff pressure Range
0 – 300 mmHg
Pressure measurement
accuracy ±3mmHg
Pulse rate range
40 to 200 bpm
Pulse rate accuracy
±2 bpm
Mobile APP

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APP function
Guided measurement,
display results, store and
share results
IOS software / hardware IOS 12.0, iPhone
Android software /
Hardware
Android 6.0 or above, mobile
phone with Bluetooth 4.0BLE
Bluetooth RF
Frequency range
2.402 – 2.480 GHz
Durable period for Monitor
Expected service life
2 years
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
inaccurate blood pressure readings.
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 an alcohol-based
sanitizer to clean the electrodes.
Do not use gasoline, thinners, or similar

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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.
Disposal
7. Electromagnetic Compatibility
The device meets the requirements of EN
60601-1-2.
Using accessories other than those specified
in this manual may result in increased
electromagnetic emissions or decreased
electromagnetic immunity for the device.
The device or its components should not be
used adjacent to or stacked with other
equipment.

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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 CISPR requirements.
When the inputted signal is below the
minimum amplitude provided in the technical
specifications, erroneous measurements
could result.
Portable and mobile communication
equipment may affect device performance.
Other devices that have RF transmitters or
sources may affect this device (e.g. cell
phones, PDAs, and PCs with wireless
functionality).
The EMC table information is listed on our website:
http://api.viatomtech.com.cn/documents/2017/emc
_en.pdf