Belter Health Measurement and Analysis Technology E10B4 Blood Pressure Meter User Manual ePA 46B

Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. Blood Pressure Meter ePA 46B

User manual

Edition：AO
VBPA
Blood Pressure Meter
user manual
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.
Referent Standards and Documents
Edition：AO
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: 2005/AC:2012
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
systems used in the home healthcare environment
EN 60601-1-11：2010
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
Secondary cells and batteries containing alkaline
IEC62133:2012
Edition：AO
or other non-acid electrolytes – Safety requirem
ents for portable sealed secondary cells, and for
batteries made from them, for use in portable a
pplications
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
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
Refer to instruction manual / booklet
IP22
Degree of protection against harmful ingress of particulate
matter and water
DISPOSAL
NOTICE
Edition：AO
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.
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
Edition：AO
. 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.
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.
.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.
Edition：AO
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 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.
To assure continued compliance, any changes or modifications not expressly approved by the party
responsible for compliance could void the user’s authority to operate this equipment.
Radiation Exposure Statement
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled
environment and it also complies with Part 15 of FCC RF Rules.
CAUTION
To comply with the limits of the Class B digital device, pursuant to Part 15 of the FCC Rules, this
device is comply with Class B limits. All peripherals must be shielded and grounded. Operation
with non-certified peripherals or non-shielded cables may results in interference to radio or
reception.
MODIFICATION
Any changes or modifications not expressly approved by the grantee of this device could void the
user’s authority to operate the device.
Edition：AO
Operating instructions:
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
Edition：AO
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
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.
（Correct diagraph posture）
Edition：AO
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.
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
Err-1
Sensor abnormal
Check whether there
is no airbag gas discharged
Edition：AO
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
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.
Err-H
pressure is too high
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
Edition：AO
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
Can not measure
Please press
【START/STOP】button,
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
Sphygmomanometer
Model number
IVBPA
Display mode
LED
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
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℃
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
Edition：AO
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
An electric charge can be used about 2 weeks
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.
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 required 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.
Edition：AO
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
2015-03

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