1
User’s Manual
Ultra-Portable Smart
Blood Pressure Monitor
Model BP1, BP1A
2
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
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.
The device and cuff are not water-resistant.
Prevent rain, sweat and water from soiling
the device and cuff.
Do not clean or maintain the device when it in
use.
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.
Used equipment, parts and battery are not
treated as ordinary household waste, and
3
must be disposed of according to the
applicable local regulations.
When reusing the device, confirm that the
device is clean.
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 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
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high-pressure oxygen chamber or an oxygen
tent. It may cause a fire or explosion.
When choosing a third party charging adaptor,
select one that complies with IEC 60950 or
IEC 60601-1.
Make sure the mobile APP installed in the
phone with IOS software / hardware is IOS
8.0 or above, iPhone 4s / iPad 3 and models
launched subsequently, or with Android
software / Hardware is Android 4.0 or above,
mobile phone or tablet with Bluetooth 4.0BLE.
2. Introduction
2.1 Intended Use
This product is intended for use in measuring
blood pressure and pulse rate for adult patient
population in home and hospital facilities.
2.2 Contraindications
This device is contraindicated for use in
ambulatory environments.
This device is contraindicated for use on
aircraft.
2.3 About the Product
5
2.4 Symbols
Symbo
l
Meaning
Type BF-Applied Part
Manufacturer
European authorized representative
CE0197
CE Marking indicating conformance
to EC directive No. 93/42/EEC
concerning medical devices.
Indicate separate collection for
electrical and electronic equipment
(WEEE).
IP22
Protected against spraying water and
against access to hazardous parts
with a tool, per IEC 60529.
6
Follow operating instructions
SN
Serial number
3. Using the Monitor
3.1Charge 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 OFF.
The monitor works in a very low power
consumption and one charge usually works for
months. When the battery is low the indicator will
be red flash.
On-screen battery symbols which indicate the
battery status can be seen on the APP.
Note: The device cannot be used during charging.
3.2LED indications
Blue blink
Powered on and Bluetooth is not
connected
Blue ON
Bluetooth connected
Red blink
Low Battery
Red ON
Charging battery
Blue-Red
blink
Pumped pressure is too high
(above 300mmHg)
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3.3Applying 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 may
cause a faint
pulse and result
in a
measurement
error.
3. Constriction of
the upper arm, caused by rolling up a
shirtsleeve, may prevent accurate readings.
4. Confirm that the artery position mark is line up
with the artery.
3.4How 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.
Do not roll up shirtsleeve tightly
1-2cm
Artery position
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3.5Connect the Monitor to Phone
Download and install the APP Air BP from Apple
Store or Google Play in your phone. Turn on the
Bluetooth on the phone from setting menu.
1. Press the button on the monitor to power on,
the indicator will be blue-flash that indicates
Bluetooth ready-to-connect status.
2. Run the APP in the phone. At the first time of
connect, the monitor will be listed in the screen
and just choose the right monitor to start the
APP. The monitor is identified by 4 numbers
which should match with the 4 ending numbers
of the device SN.
3. Make sure the phone sound is ON and the
volume is set to loud for a clear voice
instruction.
3.6Measurement
Follow the text and voice guide on the phone to
finish the measurement.
1. Pump up the cuff by squeezing the bulb at a
speed guided in the APP.
2. Stop pumping after you get an instruction, hold
the bulb with no squeeze or pressing, waiting
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for the next instruction.
3. In some cases, if the APP judged that the
pressure in the cuff is not high enough for the
measurement, then an instruction of continuous
pump will be issued. Just follow the instruction.
4. The monitor will automatically deflate the cuff
slowly during the measurement, a typical
measurement takes about 30s.
5. The blood pressure readings will appear in the
phone when the measurement finished.
Note: During the measurement, you should keep
still and don’t squeeze the bulb. Stop measuring
when the indicator turns red. Otherwise the
measurement may be effected and the blood
pressure readings may be inaccurate.
3.7After Measurement
Press the exhaust valve to exhaust air from the
cuff.
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
two minute after measurement.
Trouble Shooting
Problem
Possible
Cause
Recommended
Action
The
monitor
cannot be
connected
to the
The phone
Bluetooth is
OFF
Turn on the
phone
Bluetooth from
the setting
menu.
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phone
The phone
doesn’t support
the Bluetooth
4.0 BLE
Change to a
compatible
phone.
The
monitor
don’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-measu
re phase.
There is an
over-leakage of
press
Check if the
hose
connection is
loose.
4. Accessories
Model
Description
CU-10
Adult, arm size 22-42cm
540-00240-00
MICRO USB charge cable
Arm size: The circumference at the biceps.
5. Specifications
Classifications
11
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-condensin
g)
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(diamete
r) (main unit)
Weight
Less than 30 g (main unit)
Cuff size
Adult cuff: 22-42cm
Small adult cuff (optional):
17-22cm
Adult cuff: 22-32cm
Wireless
connectivity
Built-in Bluetooth 4.0 BLE
Power Supply
12
Charge input
Micro USB, DC5V
Battery type
Rechargeable
lithium-polymer battery
Battery run time
Approximately 1000
measurements
Charge time
2 hours
Blood Pressure
Technology
Oscillometric Method
Pressure
measurement
range
0 – 300 mmHg
Pressure
measurement
accuracy
±3mmHg or±%2，whichever
is greater
Pulse rate
range
40 to 200 bpm
Pulse rate
accuracy
±2 bpm or±%2，whichever is
greater
Mobile APP
APP function
Guide measure, display
results, store and share
results
IOS software /
hardware
IOS 8.0 or above, iPhone 4s
/ iPad 3 and models
launched subsequently
Android
software /
Hardware
Android 4.0 or above, mobile
phone or tablet with
Bluetooth 4.0BLE
Bluetooth RF
Frequency
range
2.402 – 2.480 GHz
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Max RF power
-10 dBm
6. Electromagnetic Compatibility
The device meets the requirements of IEC
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).
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Guidance and Declaration - Electromagnetic Emissions
The Blood pressure 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
Complian
ce
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 to
cause any interference in
nearby electronic equipment.
RF emissions
CISPR 11
Class B
The device is suitable for use in
all establishments, including
domestic establishments and
those directly connected to the
public low-voltage power supply
network that supplies buildings
used for domestic purposes.
Harmonic
emissions
IEC61000-3-2
Class A
Voltage
Fluctuations /
Flicker Emissions
IEC 61000-3-3
Complies
Guidance and Declaration - Electromagnetic Immunity
The Blood pressure monitor is intended for use in the
electromagnetic environment specified below. The customer or the
user of the Blood pressure monitor should assure that it is used in
such an environment.
Immunity
test
IEC60601 test
level
Complian
ce level
Electromagnetic
environment-
guidance
Electrostatic
discharge
(ESD) IEC
61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV
contact
± 8 kV air
Floors should be
wood, concrete
or ceramic tile. If
floors are
covered with
synthetic material,
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the relative
humidity should
be at
least 30 %.
Electrical
fast
transient/bur
st
IEC
61000-4-4
± 2 kV for
power
supply lines
± 1 kV for
input/output
lines
± 2 kV for
power
supply
lines
± 1 kV for
input/outp
ut lines
Mains power
quality should be
that of a typical
commercial or
hospital
environment.
Surge
IEC
61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV
line(s) to
line(s)
± 2 kV
line(s) to
earth
Voltage
dips, short
Interruptions
and Voltage
variations on
power
supply input
lines
IEC
61000-4-11
<5 % UT
(>95 % dip in
UT)
for 0.5 cycle
40 % UT
(60 % dip in
UT)
for 5 cycles
70 % UT
(30 % dip in
UT)
for 25 cycles
<5 % UT
(>95 % dip in
UT)
for 5 s
<5 % UT
(>95 % dip
in UT)
for 0.5
cycle
40 % UT
(60 % dip
in UT)
for 5
cycles
70 % UT
(30 % dip
in UT)
for 25
cycles
<5 % UT
(>95 % dip
in UT)
for 5 s
Mains power
quality should be
that of a typical
commercial or
hospital
environment. If
the user of our
product requires
continued
operation during
power mains
interruptions, it is
recommended
that our product
be powered from
an uninterruptible
power supply or a
battery.
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Power
frequency
(50/60 HZ)
magnetic
field IEC
61000-4-8
3 A/m
3 A/m
Power frequency
magnetic fields
should be at
levels
characteristic of a
typical location in
a typical
commercial or
hospital
environment.
Note: UTis the AC mains voltage prior to application of the test level.
Guidance and Declaration - Electromagnetic Immunity
The Blood pressure monitor is intended for use in the specified
electromagnetic environment. The customer or the user of the Blood
pressure monitor should assure that it is used in such an
environment as described below.
Immunit
y test
IEC606
01 test
level
Complian
ce level
Electromagnetic
environment - guidance
Conduc
ed RF
IEC6100
0-4-6
3 Vrms
150 kHz
to
80 MHz
outside
ISM
bands
3 Vrms
150 kHz
to
80 MHz
outside
ISM
bands
Portable and mobile RF
communications equipment
should be used no closer to
any part of the system,
including cables, than the
recommended separation
distance calculated from the
equation appropriate for the
frequency of the transmitter.
Recommended separation
distances:
Pd 2.1
Radiate
d RF
IEC6100
0-4-3
3 V/m
80 MHz
to
2.5 GHz
3 V/m 80
MHz to
2.5 GHz
Recommended separation
distances:
80 MHz ～ 800 MHz:
Pd 2.1
800MHz-2.5GHz:
Pd 3.2
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Where, P is the maximum
output power rating of the
transmitter in watts (W )
according to the transmitter
manufacturer and d is the
recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey
a
, should be less than the
compliance level in each
frequency rangeb.
Interference may occur in the
vicinity of
equipment marked with the
following symbol:
Note 1: At 80 MHz to 800 MHz, the separation distance for the higher
frequency range applies.
Note 2: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for
radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the
location in which the device is used exceeds the applicable RF
compliance level above, the device should be observed to verify
normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the
device.
b
Over frequency range 150kHz to 80MHz. For Resp field strength
should be less than 1V/m.
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Recommended separation distances between portable and
mobile RF communications equipment and the device
The Blood pressure monitor is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The
customer or the user of the Blood pressure monitor can help prevent
electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment
(transmitters) and the monitor as recommended below, according to
the maximum output power of the communications equipment.
Rated
max.
output
power of
transmitte
r (W)
Separation distance according to frequency of the
transmitter (m)
150 kHz - 80
MHz
Pd 2.1
80 MHz - 800
MHz
Pd 2.1
800 MHz -
2.5 GHz
Pd 3.2
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.20
1.20
2.30
10
3.80
3.80
7.30
100
12.00
12.00
23.00
For transmitters rated at a maximum output power not listed above,
the recommended separation distance d in metres (m) can be
estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the
higher frequency range applies.
Note 2: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
39
Shenzhen Viatom Technology Co., Ltd.
4E, Building 3, Tingwei industrial Park,
Honglang North 2ndRoad, Baoan,
518100 Shenzhen, P.R.China
www.viatomtech.com
info@viatomtech.com
MedNet GmbH
Borkstrasse 10 · 48163
Muenster · Germany
PN：550-01222-00 Version: B June, 2018
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