Belter ePA-46B User manual

Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd
ePA-46B
sphygmomanometer
user manual
shenzhen belter health measurement and analysis technology co.,ltd

Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd
Thank you for purchasing the BELTER electronic sphygmomanometer
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.
The sphygmomanometer is able to store up to 100 measurements per
user (maximum 2 users) and equipped with the Bluetooth Smart
technology to achieve reliable transmission linkage with a mobile device
or tablet PC that is with the logo and corresponding application. From
now on, you can easily track your health on a daily basis.
Referent Standards and Documents
No Standard Name Reference No.
1 Standard Name Reference No.
2 Medical Device Quality System for the regulation
requirement EN ISO13485: 2012
3 Medical device risk management to medical devices
application EN ISO14971: 2012
4 Symbol for the label of medical devices EN 980: 2008
5 Term, symbol and information of medical device—
information of medical device manufacturer offering EN 1041: 2008
6 Medical electrical equipment – Part 1: General
requirements for safety EN60601-1: 2006/AC:2010
7 Medical electrical equipment – Part 1-2: General
requirements for safety – Collateral standard:
Electromagnetic compatibility – Requirements and
tests
EN 60601-1-2: 2007
8 Clinical investigation of medical devices for human
subjects. General requirements EN ISO 14155-1:2009
9 Clinical investigation of medical devices for human
subjects. Clinical investigation plans EN ISO 14155-2:2009
10 Medical device software – Software life-cycle
processes EN 62304: 2006/AC: 2008
11 Medical electrical equipment – Part 1-6: General
requirements for basic safety and essential
performance – Collateral standard: Usability
EN 60601-1-6: 2010
12 Medical electrical equipment. Part 1-11:General
requirements for basic safety and essential
performance. Collateral standard:Requirements for
medical electrical equipment and medical electrical
EN 60601-1-11

Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd
systems used in the home healthcare environment
13 Medical devices – Application of usability engineering
to medical devices EN62366: 2008
14 Council Directive 93/42/EECof 14 June 1993
concerning medical devices
OJ L 169 of 12 July 1993 (including Directive
2007/47/EC )
MDD 93/42/EEC
15 Non-invasive sphygmomanometers —Part 1:
General requirements EN 1060-1
16 Non-invasive sphygmomanometers.Part
3:Supplementary requirements for
electro-mechanical blood pressure measuring
systems
EN 1060-3
17 Manual, electronic, or automated
sphygmomanometers
SP10
18 User Manual Version:1.0
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
Bluetooth function
Do not dispose this product as unsorted municipal waste.
Collection of such waste separately for special treatment is
DISPOSAL
NOTICE

Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd
necessary
This item is compliant with Medical Device Directive 93/42/EEC of
June 14,1993, a directive of the European Economic community
Refer to instruction manual / booklet
IP22
Degree of protection against harmful ingress of particulate
matter and water
Manufacturer
Authorized representative in the European Community
Date of manufacture
Serial number
SYS systolic
DIA diastolic
PUL pulse
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.

Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd
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 AA alkaline battery, don't use other batteries, otherwise may arouse
breakdown
. If the electrolyte in the battery gets into your eye, please immediately flush with a
great deal of clear water, will result into to blindness or other harmful danger, need
to immediately arrive hospital nearby to cure
. If the electrolyte in the battery glues on the skin or the clothes, please
immediately flush with a great deal of clear water, otherwise may hurt skin
Please use special arm band, otherwise may not be able to measure correctly.
If the abnormal situation of adding pressure cannot stop or abnormal air exhaustion
occurs while measuring,please remove the arm band or pull out the air
pipe,otherwise may suffer peripheral nerve disorder.
CAUTION
.Please be sure to use the appropriate cuffs band, otherwise you can't get correct
measurement
.Please don't pack a plus or minus pole of battery to pack anti-. After the battery is
used up, please replace it with new battery at the same time, long time no need to
use ,please take out the battery
. The method to abandon the battery after use please deal with it according to city
environmental protection regulations.
Please do not mix use new and old batteries,otherwise may cause leakage, fever,
fracture of the battery to damage the product.
Please use according to the storage temperature and humidity standard recored in
the user manual.

Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd
When arrhythmia situation occurs,the measurement value may be incorrect or can
not be measured.
.Please don't make an effort to curve armband and armband windpipe
.While dismantling an air tube, please take the forepart of the air tube plug to pull out
.Please don't bump shot or drop the product, this may lead to the measurement
value of the product incorrect.
Please do not add pressue before the arm band wraps around the upper arm,or you
can not get correct measurement value.
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:
How to install and replace the battery
1. Downward push the battery cover, remove the battery cover from ontology
2. Install or replace the 4 AA batteries,Make the battery positive (+) and negative (-)
extremely consistent with the marks in the battery box,and then close the battery
cover.
Please replace the battery in the state of the body cut off power.
If you remove the battery in the boot state, then count time to stop.
When the low battery icon () appears on the screen please replace 4 batteries.
Recommend alkaline battery with longer service life.
When 3 month or longer time without the use of the blood pressure please take out
the battery.
After replacing the battery, you may need to reset the date / time.
The method to abandon the battery after use please deal with it according to city
NOTICE
NOTICE

Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd
environmental protection regulations.
How to select the adapter and use
Please choose the output voltage is DC6V, output current is 1A dedicated to medical
treatment power supply adapter.
Please insert the plug of the power adapter into the power adapter interface of the
product.
Please insert the power adapter into the socket.
Please do not use nondedicated power adapter.
Even if you use the power adapter, please stall batteries into the product.
The installation of batteries is to protect the time settings.
If you do not install batteries, unplug the power adapter from the socket,the machine
will automatically stop counting time, the history data will be deleted.
Set customer, date and time
Please carry on enactment according to the sequence of customer, age, month and
date, hour and minute
Shut down status bottom, double-click 【SET 】button to get into a customer to
choose mode.
Show a customer at this time 1, press 【MEM 】button to chose customer 2:
Press 【SET 】button, set【age value 】
Press one time[memory]button, promote 1.
It can quickly change data while continuously pressing down a button
NOTICE
power
plug

Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd
The enactment scope of year is 2000-2040.If the year attains 2040, it will return
2000
Press 【SET 】button, set 【the month be worth 】
Press one time[MEM]button, promote 1.
It can quickly change data while continuously pressing down a button
Press 【SET】button, set 【date 】
Press one time[MEM]button, promote 1.
It can quickly change data while continuously pressing down a button
Press 【SET 】button, set【hour& minute 】
Press one time[MEM]button, promote 1.
It can quickly change data while continuously pressing down a button
Set unit
At shut down status, press 【SET 】button, then press 【MEM 】button to carry on
the conversion of the blood pressure unit"mmHg" and"kPa".
NOTICE

Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd
The use of memory function
Press 【MEM 】button, the device shows user's group.Press 【SET】button again, it
shows the latest diagraph result.(Press 【SET】button up to change user)
During the process of reading measuring memory,
When long press 【MEM 】button, all the memory value will be deleted.
If show "---", means delete finished.
This blood pressure is automatically save test value and pulse with measurement
date and time, 60 sets of diagraphs are kept. If saved data is over than 60 sets, the
oldest diagraph result will be deleted, newest one will be saved.
Using steps
1、Tie up arm to take
A、plug the air tube of the armband into the joint of the product.
B、open the armband,put armband air tube toward the palm inside.(as below
pictures)
NOTICE

Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd
C, fix the armband in position, as position shown in below pictures .
C、fix the armband tightly.
（Correct diagraph posture）
If you use it out of the indicated temperature and humidity range,it may not be able
to achieve claimed performance requirement.
While measuring you must ensure the correct posture to obtain accurate results.
NOTICE

Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd
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.
You'd better have a rest of 15 minutes before measurement.
data transfer
The data uploads to cellular phone or computer via blue tooth.
Key of symbols
signal Warning-see user manual Treatment
The armband fix too loose Check whether armband
is loose to move, re-
fasten tight again for
measuring.
Speaking during measurement or
move the arm Keep body and arm stable and measure again
There's interference or work not
correctly during measurement. Shut down, re-measure once.
The product leaks air or arm's
taking don't put good enough. Please check arm to take whether already put like.
Battery energy shortage Please replace battery
Excrescent check

Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd
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
Don't add to press Air plug do not plug in the
ontology of air tube correct Connect the tube correctly
The arm takes to leak air Purchase new arm to take.
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
Replace new battery
After pressing button,
don't show
Battery energy exhaustion
Replace new battery
The power gets in touch
with bad or pack anti-
The exactitude puts into
battery
Other phenomena Show the appearance
trembles
Can not measure
Please press 【ON/OFF】
button, re-operate 1 time.
Please replace battery to
try.
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
NOTICE

Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd
Name Sphygmomanometer
Model number ePA-46B
Display mode Display mode
Bluetooth Supported Bluetooth V2.0
Measurement scope The pressure measurement scope:0-280
mmHg(0-37.3 kPa)
Pulse scope: 40-200 Time/minute
Accuracy Pressure:±3 mm Hg
Pulse accuracy :±5%
Power DC6v/”AA*4”
Weight 196g
Shape size W74 mm*L152 mm*H33 mm
Arm band size: W154 mm*L 486 mm,air tube to grow
600 mm（Apply arm the scope22cm-36cm）
operating environment
a) temperature : +5℃-+40℃
a) relative humidity：15%-80%
b) 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
Battery service life 300times(alkaline dry battery can use )
product expects life span 2years
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.

Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd
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 blood pressure at easy splashing places.
Please don't put this product where there is chemical or corrosive gas.
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
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
Cuff band and air pipe line（model:BEARM-01）1PCS
Probation dry cell（4 AA batteries）
Collect soft band 1 piece
A copy of instruction for use
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

Shenzhen Belter Health Measurement and Analysis Technology Co.,Ltd
2012-09
FCC Statement
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates 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.
This device complies with Part 15 of FCC Rules.
Operation is subject to the following two conditions:
This device may not cause harmful interference, and This device must accept any interference
received, including interference that may cause undesired operation.
Note: The manufacturer is not responsible for any radio or TV interference caused by unauthorized
modifications to this equipment. such modifications could void the user’s authority to operate this
equipment.