Viatom AirBP1 User manual

AirBP
Blood Pressure Monitor
User Manual
Model：BP1, BP1A,
BP1S, BP1SA, BP1B, BP1C
Download Phone App AirBP
iOS: App Store
Android: Google Play
Note: if you’ve downloaded the app before, please
update it to the latest version.

Contents
1. The Basics...........................................................1
2. Introduction.........................................................3
3. Using the Monitor...............................................6
4. Accessories....................................................... 12
5. Specifications....................................................13
6. Maintenance and Cleaning................................14
7. FCC Statement..................................................16
8. Reference to Standards..................................... 17
9. Electromagnetic Compatibility.........................19

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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 and 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.
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.
Sources of electromagnetic disturbance may affect this device
(e.g. mobile telephones, microwave cookers,diathermy,
lithotripsy, electrocautery, RFID, electromagnetic anti-theft
systems, and metal detectors), please try to stay away from
them when making measurements.
When reusing the device, confirm that the device is clean.
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 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.

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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 apply the cuff on an arm while on an intravenous drip
or blood transfusion.
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.
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.
Do not use the device in a moving vehicle (car, airplane).
When choosing a third party charging adaptor, select one that
complies with IEC 60950 or IEC 60601-1.

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Dispose of the device, components and optional accessories
according to applicable local regulations. Unlawful disposal
may cause environmental pollution.
The patient is an intended operator.
Do not carry out the servicing and maintenance while the
device is in use.
The patient can safely use all the functions of the device, and
the patient can maintain the device by carefully reading
Chapter 6.
2. Introduction
1.1 Device Description
The blood pressure monitor includes 6 models, including BP1,
BP1A, BP1S, BP1SA, BP1B and BP1C.
The difference is shown as the table.
Items
BP1
BP1A
BP1S
BP1SA
BP1B
BP1C
Screen
×
×
√
√
√
√
Bluetooth
√
√
√
√
×
×
Color of
Enclosure
Bright
silver
Dark
silver
Bright
silver
Dark
silver
Blue
gray
Dark
green
The blood pressure monitor includes six models, BP1, BP1A,
BP1S, BP1SA, BP1B, and BP1C. It uses the oscillometric
method to measure blood pressure, the BP1, BP1A, BP1S,
BP1B support Bluetooth, while BP1B and BP1C don’t. The
monitor is comprised of cuff, main unit, rubber bulb, exhaust
valve and air hose.

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The blood pressure data is displayed, stored and reviewed
including the systolic and diastolic blood pressure and pulse
rate in an application which is installed in smart phone or the
machine itself.
1.2 Intended Use
The subject device intended to measure the diastolic, systolic
blood pressures and pulse rate for adult population in home
and hospital facilities by using a non-invasive oscillometric
technique with a single upper arm cuff (22-42 cm).
The device detects the appearance of irregular heart beats
during measurement and gives a warning signal with
readings.
1.3 Contraindications
This device is contraindicated for use in ambulatory
environments.
This device is contraindicated for use on aircraft.
1.4 Symbols
Symbol
Meaning
Application part type BF
Manufacturer

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Date of manufacture
SN
Serial number
Indicates a medical device that is not to be
disposed of as unsorted municipal waste.
IP22
Dustproof and waterproof level
Follow operating instructions
MR Unsafe – keep away from magnetic
resonance imaging (MRI) equipment.
CE marking
Authorized representative in the European
community
This product complies with the rules and
regulations of the Federal Communication
Commission.
Stop pumping
Pulse rate
Power off
Battery low
Charging

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3. Using the Monitor
Download App AirBP
iOS: App Store
Android: Google Play
Note: if you’ve downloaded the app before, please update to the
latest version.
3.1 Charge the Battery
Charge the monitor by using the USB cable to connect a USB
charger or to the PC USB Port. A fully charge takes 2 hours.
Note: The device cannot be used during charging.
3.2 Applying the Arm Cuff
Do not roll up shirtsleeve tightly
1-2cm
Artery position mark

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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 rolling up a
shirtsleeve, may prevent accurate readings.
Confirm that the artery position mark is line up with the
artery.
3.3 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. Sit with your
back and arm being supported. Place your arm on a
table so the cuff is level with your heart.
3.4 Single machine measurement
Press the power button to start the machine and enter the
interface of waiting for measurement. Then start
pumping according to the instructions. When the stop
pumping sign is recognized, stop pumping and wait for
the measurement result.
Stop Pumping

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Measuring Result
3.5 Connect the Monitor to Phone App
1. Turn on the Phone Bluetooth.
2. Press the button to power on the monitor, the indicator
will be blue-flash that indicates Bluetooth
ready-to-connect status.
3. Run the APP AirBP on your smartphone. App will
search the device. Choose your device “AirBP xxxx” in
App.
Note:
Keep the distance between monitor and phone within
1.5 meter.
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 voice is turned on and the
volume is loud enough. Follow the text and voice guide
in App to measure.

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In App->Measure,
Click the “START” button on the App Measure
Screen to start the measurement, and follow the
instruction to pump up the cuff by squeezing the
bulb at a speed guided in App.
Stop pumping after you get the instruction, hold
the bulb with no squeeze or pressing, waiting for
the next instruction. In some cases, if the App
judged that the pressure in the cuff is not high
enough for the measurement, then an instruction
of “pump again” will be issued.
Note: During the measurement, you should keep still.
Otherwise the blood pressure readings may be inaccurate.
Stop pumping when the indicator blue-red blinks (pressure is
too high).

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3.7 After Measurement
The blood pressure readings will
appear on the app interface when
the measurement finished. You
need to manually press exhaust
valve to deflate the cuff. If you forget to deflate
manually after measurement, the monitor will
automatically deflate the cuff slowly, and it takes
less than 30s for finishing the whole automatic
deflation.
On result page, you can add the user name or ID
(help you manage multiple users data), add note,
share the results or delete it.
If the monitor detects the irregular heartbeat, and
the corresponding symbol will display below to
the PR value.
Note: The device turns off automatically in two minute if no
working.

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3.8 Review the history
In App History, you can check the history list.
You can select a specific ID or All.

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3.9 Trouble Shooting
4. Accessories
Arm size: The circumference at the biceps.
Problem
Possible Cause
Recommended Action
The monitor
cannot be
connected to
the phone
The phone Bluetooth
is OFF
Turn on the phone
Bluetooth from the
setting menu.
The phone doesn’t
support the Bluetooth
4.0 BLE
Change to a compatible
phone.
The monitor
doesn’t
response to the
button press.
The monitor is
running in an
unexpected status.
Reset the device by press
and hold the button for
5s.
Cannot get
blood pressure
readings.
The measurement is
interrupted by arm
movement or
unexpected bulb
squeeze.
Keep arm still and don’t
squeeze the bulb during
deflating-measure phase.
There is an
over-leakage of press
Check if the hose
connection is loose.
Model
Description
CU-10
Adult, arm size 22-42cm
540-00240-00
MICRO USB charge cable

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5. Specifications
Classifications
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
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
Charge input
Micro USB, DC5V
Battery type
Rechargeable lithium-polymer
battery 3.7Vdc, 130mAh
Charge time
2 hours
Blood Pressure
Technology
Oscillometric Method
Measuring Range
0 – 299 mmHg
DIA Range
40-150 mmHg
SYS Range
60- 230 mmHg
Pressure measurement
accuracy
±3mmHg
Pulse rate range
40 to 200 bpm
Pulse rate accuracy
±2 bpm

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Mobile APP
APP function
Guide measure, display results, store
and share results
IOS software / hardware
IOS 12.0, iPhone launched
subsequently
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 and Cleaning
6.1 Maintenance
To protect your device from damage,
• Store the device and the components in a clean, safe
location.
• Do not wash the device and any components or
immerse them in water.
• Do not disassemble or attempt to repair the device or
components.
• Do not expose the device to extreme temperatures,
humidity, dust or direct sunlight.
• The cuff contains a sensitive air-tight bubble. Handle
this carefully and avoid all types of straining through
twisting or buckling.
• Clean the device with a soft, dry cloth. Do not use
petrol, thinners or similar solvent. Spots on the cuff can
be removed carefully with a damp cloth and soapsuds.
The cuff must not be washed!
• Do not drop the instrument or treat it roughly in any

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way. Avoid strong vibrations.
• Never open the device! Otherwise the manufacturer
calibration becomes invalid!
6.2 Cleaning
• Clean the device with a soft, dry cloth with 70%
alcohol.
• Do not use petrol, thinners or similar solvent.
• Clean the cuff carefully with cloth soaked 70%
alcohol.
• The cuff must not be washed!
• Clean on the monitor and the arm cuff, and then let it
air dry.
6.3 Disposal
Batteries and electronic instruments must be
disposed of in accordance with the locally applicable
regulations, not with domestics waste.

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7. FCC Statement
BP1、BP1A FCC ID: 2ADXK-8611
BP1S、BP1SA FCC ID: 2ADXK-8612
1. 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.
(2) This device must accept any interference received, including
interference that may cause undesired operation.
Note: The grantee is not responsible for any changes or
modifications not expressly approved by the party responsible for
compliance. Such modifications could void the user’s authority to
operate the equipment.
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 off and on, 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 receiver.
-Connect the equipment into an outlet on a circuit different from that
to which the receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help
Note: Changes or modifications not expressly approved by the
party responsible for compliance could void the user's authority to
operate the equipment.
RF Exposure
The monitor complies with FCC radiation exposure limits set forth
for an uncontrolled environment.

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8. Reference to Standards
IEC60601-1:2005+A1:2012
IEC60601-1-2:2014
IEC/EN60601-1-11:2015
IEC80601-2-30:2009+A1:2013
ISO81060-2:2013
FCC part 15
Plot of DBP difference between the paired blood pressure determinations against the
reference diastolic measurement

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The Bland-Altman Plots originated form clinical test, which data was gathered from
adult healthy volunteers in a controlled study.
The clinical test applies for the BP1S device with one cuff size, comparing with
Mercury sphygmomanometer.
The result met the criteria specified in ISO 81060-2:2013; In addition, there were no
reported adverse effects during these investigations.
Plot of SBP difference between the paired blood pressure determinations
against the reference systolic measurement