SIFSOF SIFBPM-3.7 User manual

Blood Pressure Monitor
User Manual
Model SIFBPM-3.7
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.

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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

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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.
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

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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.
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 uses the oscillometric
method to measure blood pressure with bluetooth
technology.The monitor is comprised of cuff, main unit,
rubber bulb, exhaust valve and air hose. 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.
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

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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
1.5 Display Symbols
Irregular heartbeat symbol ( )
Symbol
Meaning
Application part type BF
Manufacturer
WEEE (Waste Electrical and Electronic
Equipment) mark, Electronic
instruments must be disposed in
accordance with the applicable local
regulations
IP22
Dustproof and waterproof level
Follow operating instructions
MR Unsafe – keep away from magnetic
resonance imaging (MRI) equipment.
SN
Serial number

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When the monitor detects an irregular rhythm two or more
times during the measurement, the irregular heartbeat symbol
will appear on the display along with the measurement values.
An irregular heartbeat rhythm is defined as a rhythm that is 25%
less or 25% more than the average rhythm detected while the
monitor is measuring the systolic and diastolic blood pressure.
If the irregular heartbeat symbol displays with your
measurement results, we recommend you consult your
physician. Follow the directions of your physician.
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.

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During charging, the LED is red. When full charged, it
will power off automatically.
When the battery is low the indicator will be red flash.
In app, you can check the battery level.
Note: The device cannot be used during charging.
3.2 LED indications
Blue blink
Powered on and Bluetooth is not connected
Blue ON
Bluetooth connected
Red blink
Low Battery
Red ON
Charging battery when not connected to App
Blue-Red
blink
Pumped pressure is too high (above
300mmHg)
3.3 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.
3.4 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 your back and arm being supported. Place
your arm on a table so the cuff is level with your
heart.
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

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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.
In App->Measure,
Click the “START” button on the App

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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).
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

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below to the PR value.
Note: The device turns off automatically in two minute if
no working.
3.8 Review the history
In App History, you can check the history list.
You can select a specific ID or All.
3.8 Trouble Shooting
Problem
Possible Cause
Recommende
d Action
The monitor
cannot be
connected to
the phone
The phone
Bluetooth is OFF
Turn on the
phone
Bluetooth from
the setting
menu.

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4. Accessories
Arm size: The circumference at the biceps.
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-meas
ure phase.
There is an
over-leakage of
press
Check if the
hose
connection is
loose.
Model
Description
CU-10
Adult, arm size 22-42cm
540-00240-0
0
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
Charge time
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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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
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

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soapsuds. The cuff must not be washed!
• Do not drop the instrument or treat it roughly in
any 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.
7. FCC Statement
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

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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. This device should be installed and operated with
distance 1.5 m between the radiator & your body.

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Plot of DBP difference between the paired blood pressure determinations
against the reference diastolic measurement
The Bland-Altman Plots originated form clinical test, which data was gathered
Plot of SBP difference between the paired blood pressure
determinations against the reference systolic measurement

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from adult healthy volunteers in a controlled study.
The clinical test applies for the SIFBPM-3.7 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.
9. 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).
EMC table information is listed this file :
https://drive.google.com/file/d/1pHNxa03pyzVQ2C2UyrJzZxBQuuIZDZJ-/view

EST. 2005
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