Belter Health Measurement and Analysis Technology EPA-13B4 Blood Pressure Meter User Manual ePA 46B
Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. Blood Pressure Meter ePA 46B
User manual
Edition：
1
ePA-13B4
Blood Pressure Meter
user manual
Edition：
2
shenzhen belter health measurement and analysis technology co.,ltd
Thank you for purchasing the BELTER electronic Blood Pressure Meter
This product is a sphygmomanometer which uses noninvasive method to
measure human blood pressure.Please be sure to read the instructions
before use.After reading, please safekeeping for inspection at any time,
reference.
Scope of application: used for blood pressure and pulse measurement of
human body. （not suitable for Neonatal）
Important safety notes
SIGNS AND SYMBOLS
The following signs appear in this manual. READ THE SAFETY SECTION AND ALL
INSTRUCTIONS AND WARNINGS COMPLETELY AND CAREFULLY BEFORE USING
THIS PRODUCT. FOLLOW ALL SAFETY INSTRUCTIONS AND WARNINGS TO AVOID
HAZARDOUS SITUATIONS AND TO MAKE CORRECT USE OF THIS PRODUCT.
symbol
Description
WARNING
WARNING indicates a hazardous situation which, if not avoided,
could Result in death or serious injury
CAUTION
CAUTION indicates a hazardous situation which, if not avoided,
may result in minor or moderate injury
NOTICE addresses practices not related to personal injury, such
as product and/or property damage
Type BF
Do not dispose this product as unsorted municipal waste.
Collection of such waste separately for special treatment is
necessary
This item is compliant with Medical Device Directive 93/42/EEC of
June 14,1993, a directive of the European Economic community
NOTICE
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Refer to instruction manual / booklet
Keep dry
Manufacturer
Authorized representative in the European Community
Date of manufacture
Serial number
SYS
systolic
DIA
diastolic
PUL
pulse
Bluetooth connection symbol
warning
Do not use this product in the mixed gas of flammable gas with air or wih
oxygen or with nitrous oxide conditions.
Do not dispose of electrical appliances as unsorted municipal waste, use
separate collection facilities. Contact you local government for information regarding
the collection systems available. If electrical appliances are disposed of in landfills or
dumps, hazardous substances can leak into the groundwater and get into the food
chain, damaging your health and well-being.
The device is not suitable for use in the presence of flammable anesthetic
mixtures with air or with oxygen or nitrous oxide.
The device requires no calibration.
The device is not repairable and contains no user serviceable parts.
No modification of this equipment is allowed.
Remove batteries if equipment is not likely to be used for some time.
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The user must check that the equipment functions safely and see that it is in
proper working condition before being used.
The manufacturer does not require such preventive inspections by other
persons.
. It is dangerous to carry on self judgment and self treatment by the sufferer
himself,so please follow doctor’s instruction. Self judgment may lead to exacerbation
of disease
. Get a serious blood circulation obstacle, blood paroxysm sufferer, please use
under the doctor's instruction, while measuring because the arm is squeezed may
cause impatient internal bleeding
. Infant and person not be able to express himself,please do not use
. Please control the add pressue to the armband in the range of 300 mmHgs(40
kpas) , otherwise the arm may appear blood clot, benumbed symptom
. This product is only used for human body blood pressure measurement and used
outside the purpose of measuring human body blood pressure, may take place
accident
. Please don't use a cell phone in the neighborhood of this product and have the
danger to make product mistake action
. Please don't dismantle to unload or fix by yourself, reformation of the blood
pressure account of essence or armband, otherwise can not measure correctly
Please use special arm band, otherwise may not be able to measure correctly.
If and when measuring pressure cannot stop or abnormal exhaust abnormal
situation, please press the "START/STOP", otherwise you may suffer
from peripheral nerve disorder.
If and when measuring pressure cannot stop or abnormal abnormal gas
exhaust, press the "START/STOP" no action, please manually release the arm belt.
not suitable for use together with the HF surgical equipment
Please avoid sharing with others, may cause skin allergies or cross infection
CAUTION
.Please be sure to use the appropriate cuffs band, otherwise you can't get correct
measurement
Please use according to the storage temperature and humidity standard recored in
the user manual.
When arrhythmia situation occurs,the measurement value may be incorrect or can
not be measured.
.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
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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.
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, and (2)
this device must accept any interference received, including interference that may
cause undesired operation.
Any 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 equipment complies with FCC radiation exposure limits set forth for an
uncontrolled environment.
.Please don't bump shot or drop the product, this may lead to the measurement
value of the product incorrect.
When the plug or wire of the power adapter is damaged,please immediately drawn it
out of the socket,otherwise may cause the danger of fire or electric shock.
Please do not use wet hand to pull the power adapter from the socket,otherwise may
cause electric shock or fire burn.
Operating instructions:
NOTICE
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Using steps
1、Please charge the product performed before use
2、Please take off your coat
3、According to the product label "UP\DOWN", will be inserted in the arm cuff
4、Adjustment arm, make the product center position and heart at the same level
Main body
Display area
Arm belt
Direction
Function keys
charging interface
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5、Press start / stop button to start the measurement (SART/STOP)
6、The compression process is complete, the product will gradually reduce the pressure cuff,
relax and keep still and not to talk
7、After the measurement is completed, the air arm belt will be automatically discharged, the
measurement results will be displayed on the surface of the corresponding column
The initial use, please charge the battery, because the internal product factory charged amount and
the storage time of products can lead to battery power consumed.
If wear a thick coat, please take it off, in order to better measure
Pay attention to dress more thick coat will cause a weak pulse, the measurement results of error
Any time to terminate the measurement, but just need to press the start /
stop button(START/STOP), quick exhaust valve will quickly decrease with pressure in the arm
Such as the continuous measurement, the interval time should exceed 10 minutes
Such as the continuous measurement, the interval time should exceed 10 minutes
regarding the effect of blood flow interference and resulting harmful injury to the
PATIENT caused by continuous CUFF pressure due to connection tubing kinking;
too frequent measurements can cause injury to the PATIENT due to blood flow
interference;
don’t place CUFF over a wound, as this can cause further injury;
NOTICE
（Correct diagraph posture）
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don’t place CUFF and its pressurization on any limb where
intravascular access or therapy, or an arterio-venous (A-V) shunt, is present because
of temporary interference to blood flow and could result in injury to the PATIENT;
don’t place CUFF and its pressurization on the arm on the side of a mastectomy;
pressurization of the CUFF can temporarily cause loss of function of simultaneously used
monitoring ME EQUIPMENT on the same limb;
regarding the need to check (for example, by observation of the limb concerned)
that operation of the AUTOMATED SPHYGMOMANOMETER does not result in prolonged
impairment of the circulation of the blood of the PATIENT.
adjustment of the pressure reduction rate, if applicable, PATIENT position in NORMAL USE,
including
1) comfortably seated
2) legs uncrossed
3) feet flat on the floor
4) back and arm supported
5) middle of the CUFF at the level of the right atrium of the heart
– a recommendation that the PATIENT relax as much as possible and not talk during the
measurement PROCEDURE,
– a recommendation that 5 min should elapse before the first reading is taken;
How to select the adapter and use
Please choose the output voltage is DC5V, output current is 1A dedicated to medical treatment
power supply adapter.
Please read the wiring in the annex to the insertion product and then connected to the power supply.
The product is energized by "START/STOP" key prompt product " " flash, the charging
is completed " " long light prompt
When charging products can not use
If you use it out of the indicated temperature and humidity range,it may not be able
to achieve claimed performance requirement.
NOTICE
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While measuring you must ensure the correct posture to obtain accurate results.
Even forget to turn off the power ,after about 2 minutes it will shutdown
automatically .
Please measure and control blood pressure at the same time every day.
Measurement should be taken in quiet places ,the measured person should be in a
relaxed sitting position.
The product is energized by "START/STOP" key prompt product "8" flash, the charging is
completed "8" long light prompt
You'd better have a rest of 15 minutes before measurement.
Adapters that are recommended in the instruction manual may cause fire or electric shock
data transfer
The data uploads to cellular phone or computer via blue tooth.
Key of symbols
signal
Warning-see user manual
Treatment
Err-1
Sensor abnormal
Check whether there
is no airbag gas discharge
d
Err-2
Blood pressure was not detected in
heart or can't figure out
Check if the dress is
too thick
Err-3
Abnormal measurement results
Keep body and arm stable
and measure again
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Err-4
Cuff too loose or leakage (10
seconds pressure less
than 30mmHg)
Shut down, re-measure
once.
Err-5
trachea is blocked
To test whether a hard
object
Err-6
High pressure
fluctuation measurement
Keep body and arm stable
and measure again
Err-7
Pressure exceeds the upper limit
Please check arm to take
whether already put like.
Battery energy shortage
Please charge
Excrescent check
Excrescent
circumstance
Reason
Treatment
Measured result is big
deviation from normal
Armband doesn't take
correctly
The exactitude ties up good
arm to take
talks or moves arm during
the measuring
Keep quiet and measure
The clothes of curling up
oppressed arm
take off the clothes and
measure again
The arm takes in the in a
short time to carry on
exhaustion
The arm takes to tie up too
loosely
Please tie up tight arm to
take
Add to ran over distance in
suddenly the power failure
reset clock
Battery energy exhaustion
Please charge
After pressing button, don't
show
Battery energy exhaustion
Give product charge
Other phenomena
Show the appearance
trembles
Please press
【START/STOP 】button,
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Can not measure
re-operate 1 time.
Please charge the battery In
addition still can not
measure, please consult
room contact with BELTER
healthily
This product has carried on check in the factory,please execute strictly in
accordance with the instruction manual.
function specification
Name
Blood Pressure Meter
Model number
EPA-13B4
Display mode
LED
Measurement scope
The pressure measurement scope:0-295
mmHg
DIA:25-245 mmHg SYS:55-255 mmHg
Pulse scope:
40-199 bpm
Accuracy
Pressure:±3 mm Hg
Pulse accuracy
:±5%
Power
DC5v/
Weight
265g
Shape size
W70 mm*L155 mm*H74mm
Arm band size:
Arm belt500mm×130mm（Apply arm the
scope22cm-36cm）
operating environment
a) temperature : +5℃-+40℃
b) relative humidity：15%-80%
c) atmospheric
pressure :700hpa-1060hpa
Transportation and storage environment
a)temperature :-20℃-+50℃
b)relative humidity：15%-90%
c)atmospheric
pressure :500hpa-1060hpa
Protection against electric shock
internal electric source,.BF application
part
clinical allow maximum error margin
This product pass clinical verification,
the clinical maximum allowable error is
≤±5mmHg/±0.67kPa
Full power available time
Such as a day to measure three times,
about one week
NOTICE
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Lithium battery charge cycle life
About 400 cycles
product expects life span
3years
CLASSIFICATION
1. Internally powered equipment;
2. Type BF applied part: cuff;
3. IP22;
4. Not category AP / APG equipment;
5. Mode of operation: continuous operation.
Cleaning, maintenance and Storage
Please always clean sphygmomanometer.
Please use clean soft cloth ,gently wipe the LCD and shell, do not use solvents, and do
not be soak it in water or other liquids.
Please do not wash the arm band of the product.
If the product is especially dirty you can use a soft cloth with water or neutral detergent,
fully wring dry to wipe the product.
Please do not use gasoline, thinner or similar solvent to clean arm band.
When you do not use, please storage the sphygmomanometer and accessories in the
collection bag.
Please do not place the sphygmomanometer and arm band in high temperature, damp,
full of water vapor or direct sunlight conditions.
Please do not let the blood pressure cuff suffer strong shock or vibration (e.g., fell on the
ground).
Please do not put the product in direct sunlight, high temperature, humidity, dust,
corrosive gas many places to save, such as non-compliance will lead to product
damage
This product is not a toy, please do not play with the children and stored in children can
not get the place,
Storage of this product should be prevented from the damage caused by the pet and
pest.
Please do not dismantle the blood pressure.
Please storage the product in requied environment.
Calibration and repair
This product has been calibrated and tested when delivered from the factory.
If you have doubt about the measurement result of the product ,
please contact us and give the product to specialized person to repair
Warranty:
If you use the device according to the manual, replace it within 3 months and guarantee
for free a year.
The following situations are not included in warranty time:
1） problem caused by self dismounting
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2） problem caused by shocking during use or delivery.
3） problem caused by incorrect maintenance
4） problem caused by incorrect operating, problems caused by unprofessional repair.
Product Composition
A piece of the product
A copy of instruction for use
A charging connection wire
Adverse events :non
ShenZhen Belter Health Measurement and Analysis Technology Co.,ltd
702/704, Block C, Tsinghua Unis Science Park, No.13 Langshan Rd, Hi-Tech Industrial
Park(north), Nanshan District, 518057 Shenzhen, People’s Republic of China
2018-03