iProven BPM-634 User manual

Blood Pressure Monitor
Instruction Manual
iProvèn BPM-634
Thankyou for making iProvèn your top choice. Please read the instructions carefully in order to accurately and
safelyutilize this equipment.
TheBPM-634 measures the blood pressure and the heart rate and saves the results. It also enables transferring the measurement
usingthe Bluetooth connection. The BPM-634 oers real time and accurate readings that are as convenient as possible thanks
tothe Oscillometric Measuring method. Blood pressure measurements may not be valid or accurate if they are not performed in
accordancewith the instructions provided in this manual, so please keep these instructions handy for future reference.
Youcan also nd the digital version of this manual on www.iproven.com
It is our passion todevelop high quality products for home use. Our products are manufactured at the highest technical
standardsof professional quality, durability, and consistency. They are also designed with elegantsimplicit y in mind,mak ing them
easyto use at home.
Tohelp you get the most from our products, we provide clear instructions with each device. The manual also includes helpful
informationthat contributes to your overall health awareness.
Inorder to make sure that our products are tailored to your needs, we welcome your feedback. If you have any issues, questions or
recommendations,please share your thoughts with us at www.iproven.com
iProvèn- Professional Care Brought Home
iProvènis a Masena Invest brand
Intended use of the BPM-634 blood pressuremonitor
TheBPM-634 is a digital monitor that is used for measuring blood pressure and heart rate by wrapping the cu around arms of
dierentsizes, within 8¾˝ - 16½˝ (22 cm to 42 cm). The BPM-634 is intended for home use and for adults only.
How this deviceworks
Theproduct uses the Oscillometric Measuring method to detect blood pressure. When the measurement is started, it calibrates
to“zero pressure”which is the natural air pressure. As soon as it starts inating the wrist cu, the device detects the pressure
oscillationsaccording to the beat-to-beat pulsatile and so it determines the systolic, diastolic pressure and the heart rate.
Irregular Heart Beat detection
Thedevice is equipped with irregular heart beat detection, IHB. The algorithm of the device compares the longest and shortest
intervalsof registered pulse waves (the time interval) and calculates the standard deviation. If the dierences in the time intervals
aremore than 25% you have an irregular heartbeat and the signwill appear in the display. If the device detects irregular
heartbeat during consecutivemeasurements and you are following the correct procedure, please consult your doctor.
Intended use of the BPM-634 blood pressuremonitor
• Theunit should not be used for prolonged monitoring during medical emergencies or operations.
• Thecu being inated for a prolonged time will lead to numbness of wrist and ngers, causing anesthesia, pain and ecchymosis.
• Usethe device according to the instructions of this manual to guarantee an ecient performance and durability of the device.
• Thecu complies with the requirements of ISO 10993-5:2009 and ISO 10993-10:2010.
• Thecu does not cause any potential allergic reaction or contact injury.
• Thereis no need for calibration during the two years of ‘guaranteedser vice’.
Setting up the device
1. Firstmake sure you set the time and data correctly so the device can register the results with the correct time;
2. Withthe monitor OFF, press SET.The time will now show in the display;
3. Holdthe SE T buttonfor 3 seconds until the “Year”star ts blinking;
4. Pressor hold MEM to adjust the Year digits that are blinking on the display.Press SET to conrm;
5. Repeatstep 2 for setting the Month & Day, Hour & Minutes;
6. Oncethe Minutes are set, the display will show “mmHg”. This is the standard measurement unit. PressSE T to save;
Orpress MEM to change to “kPa”and then press SET to save;
7. Oncethe measurement unit is set, the LCD will show “DONE”.Then the device will show the settings and then shut o.
Takinga measurement
1. Beseated in a quiet and comfortable room, with your arm resting on a at surface;
2. Afterwrapping the cu (see “wrapping the cu” section), rest 3 minutes, keep your the palm of your hand upwards, your
backstraight and breathe deeply for 5 or 6 times before starting the measurement;
3. PressSTART to begin the measurement;
4. Themonitor will rst calibrate to zero air pressure and then inate the cu. While inating the measurements are made;
5. Whenthe measurement is completed the results will appear in the screen. The measurement is also saved in the memory.
Tips forbetter accuracy
• Duringthe measurement do not move or speak and be seated in a silent room;
• Donot cross your legs during the measurement;
• Donot use the device in a toilet or while doing any sort of ac tivity including talking or moving;
• Donot use the device in a cold environment;
• Toget insight in the trend of your blood pressure, it is best to measure your blood pressure at about the same time(s) every day;
• Foraccurate results, avoid using the device within 1 Hour after eating;
• Youshouldn’t measure immediately after drinking tea or coee and after smoking;
• Avoidmeasuring after 30 minutes of taking a shower or bath;
• Foran accurate and clear result, please measure the same arm every time;
• Asa rule of thumb: when you measure your left arm, position the hose in line with the index nger. For even higher accuracy,
makesure the ART sign on the cu is closest to the arter y.You can locate the artery by pressing 2 ngers 1 inch above the bend
ofyour elbow on the inside of your arm. The artery is where you can feel the pulse the strongest.
Wrappingthe cuff
Whenwrapping the cu around your upper arm, make sure that:
• TheART sign of the cu is close to the arter y;
• Thecu is positioned around an inch from the bent of your arm;
• Thecu is snug but not too tight. You have to be able to insert
onenger between the cu and the arm.
Preparing the measurement
The LCDdisplay and the meanings of the symbols
Components of the BPM-634
• Connectthe cu by inser ting the air plug intothe air jack
onthe left side of the device.
• Openthe batter y cover;
• Insert the four AA batteries conformthe right polarity ;
• Closethe batter y cover;
Preparing the device
(0.8 -1.2 )
SYMBOL DESCRIPTION
Systolic pressure High blood pressure
Diastolic pressure Low blood pressure
EXPLANATION
Memory
mmHg
kPa
Measurement Unit of the blood pressure
Measurement Unit of the blood pressure
Low battery Batteries are low and need to be replaced
Current Time Year/Month/Day, Hour : Minute
(1kPa=7.5mmHg)
(1mmHg=0.133kPa)
Heartbeat
Irregular heartbeat
Motion indicator Indicates detected motion try to avoid
Pulse in beats per minutePulse display
Indicates it is in the memory mode and
the measurement number
Blood pressure monitor is detecting an
irregular heartbeat during measurement
Blood pressure
level indicator Indicates the blood pressure level
Blood pressure monitor is detecting a
heartbeat during measurement
Deleting the records
Incase you want to delete your recorded measurements, please follow these steps:
1. Makesure the monitor is inactive. If the monitor is not yet inactive, rst deactivate it by pressing STOP;
2. PressMEM to go to Memory ;
3. Pressand hold the MEM button for 3 seconds;
4. “DELALL” will start blinking. Press SET to conrm. (Or pressSTOP to cancel);
5. “DELDONE” will show, meaning the stored data is deleted.The device will shut o.
Using the memory function
• Everymeasurement is automatically saved in the memory, with a maximum capacity of 60 measurements;
• Makesure that the date and time are set correctly;
• Toview the recorded data press the MEM button while the monitor is inactive;
• Ifthe monitor is not yet inactive, rst deactivate it by pressing STOP;
• Usethe buttons MEM for Up and Set for Down to read through the records.
ManualVersion: 2.0
IssuingDate: 2018/01/03
©2017.All rights reserved.

Basic info about blood pressure
Systolicpressure means that the ventricles contract and pump out blood, increasing the blood pressure. The diastolic pressure
meansthat the ventricles relax so the blood pressure decreases.
AHA indicator
Aftereach measurement an arrow indicates the corresponding AHA category color on the left of the display. The colors represent
thedierent categories of the American Heart Association blood pressure classication as depicted in the chart below.
Electromagnetic compatibility measures
Pleasepay attention to the precautions of EMC
(ElectromagneticCompatibility) of this Monitor. The
BloodPressure Monitor must be installed and used
accordingto the EMC information shown in this manual.
Thedevice can be aected by portable and mobile RF
communicationequipment.
Removeany devices that emit electromagnetic elds
suchas mobile phones from nearby the device.
TheBlood Pressure Monitor has been tested and
inspectedto guarantee a proper performance.
Donot store or use this Monitor with other electric
equipment.
Manufacturer’sdeclaration on Electromagnetic Immunity for all ME Equipments and Systems Manufacturer’sdeclaration on Electromagnetic Immunity for all ME Equipments
and Systemsthat do not provide LIFE-SUPPORTING
The safe distancesbet weenpor table and mobile RF communications
equipment, ME Equipments and Systemsthat are not LIFE-SUPPORTING
Changes in blood pressure
Thereare many factors that cause the
bloodpressure to change. Weather,
emotions,stress, food, physical activities;
allthese inuence the variations in
theblood pressure. Bear in mind that
measuringin clinical settings tend to
causethe blood pressure to increase.
Thisis called “white coat eect”.
Error messages and FAQ Important symbols on the monitor
PROBLEM SYMPTOM CHECK THIS REMEDY
Nopower
Low
batteries
Error
message
Displaywill not
lightup.
Batteriesare exhausted. Replacewith new batteries
Insertthe batteries
correctly
Replacewith new batteries
Batteriesare inserted
incorrectly.
Displayis dim or
show Batteriesare low.
E01 shows
E03 shows
E04 shows
EExx,showson
thedisplay.
Acalibration error
occurred.(XX can
besome digital symbol,
suchas 01, 02,etc., if
thissimilar situation
appear,all belong to
calibrationerror.)
Retakethe measurement.
Ifthe problem persists,
contactthe retailer or our
customerservice
departmentfor further
assistance.Referto the
warrantyfor contact
informationand return
instructions.
Thetreatment of the
measurementfailed.
E02 shows
Thecuff is too tight
ortoo loose.
Refastenthe cuff and then
measureagain.
Themonitor
detectedmotion
whilemeasuring.
Movementcan affect the
measurement.Relaxfor a
momentand then
measureagain.
Relaxfor a moment and
thenmeasure again.
Themeasurement
processdoes not
detectthe pulse
signal.
Loosenthe clothing on
thearm and then
measureagain.
Warning
message
Relaxfor a moment.
Refastenthe cuff and then
measureagain. If the
problempersists, contact
yourphysician.
“out” shows Outof measurement
range
About22cm~42cm
TypeBF applied part
Powersupply
Displaymode
Measurementmode Oscillographictesting mode
Measurementrange
Measurementperimeter
ofthe upper arm
Weight Approx.260g(Excludingthe dry cells and cuff)
Externaldimensions
Attachment
Modeof operation Continuousoperation
Degreeof protection
Protectionagainst
ingressof water
Accuracy
Normalworking condition
Storage& transportation
condition
SoftwareVersion A01
Pressure:
5℃-40℃within±3mmHg(0.4kPa)
Pulsevalue:±5%
Ratedcuff pressure:
0mmHg~299mmHg(0kPa~ 39.9kPa)
Measurementpressure:
SYS:60mmHg~230mmHg (8.0kPa~30.7kPa)
DIA:40mmHg~130mmHg (5.3kPa~17.3kPa)
Pulsevalue: (40-199)beat/minute
IP21It means the device could protected against
solidforeign objects of 12.5mm and greater, and
protectagainst vertically falling water drops.
DeviceClassification
BatteryPowered Mode:
InternallyPowered ME Equipment
ACAdaptor Powered Mode: Class II ME Equipment
Atemperature range of :+5°C to +40°C
Arelative humidity range of 15% to 90%,
non-condensing,but not requiring a water
vapourpartial pressure greater than 50 hPa
Anatmospheric pressure range of :
700hPa to 1060 hPa
Temperature:-20°Cto +60°C
A relative humidity range of ≤ 93%,
non-condensing,at a water vapour pressure
upto 50hPa
Symbolfor “THE OPERATION
GUIDEMUST BE READ”
Symbolfor “MANUFACTURER”
Symbolfor “SERIAL NUMBER”
Symbolfor “TYPE BF APPLIED
PARTS”
Symbolfor “DIRECT CURRENT”
Symbolfor “ENVIRONMENT
PROTECTION- Electrical waste
productsshould not be disposed of
withhousehold waste. Please recycle
wherefacilities exist. Check with your
localauthority or retailer for recycling
advice”
Symbolfor “MANUFACTURE
DATE”
Caution:These notes must be
observed to prevent anydamage
to the device.
SN
TheGreen Dot is the license
symbolof a European
networkof industry-funded
systemsfor recycling the
packagingmaterials of
consumergoods.
Symbolfor “Recycle”
Complied EuropeanStandards List
ENISO 14971:2012 / ISO 14971:2007 Medical devices -
Applicationof risk management to medical devices
EN980:2008 Symbols for use in the labelling of medical devices
EN1041:2008 Information supplied by the manufacturer of medical
devices
EN60601-1:2006/ IEC 60601-1:2005+A1:2012 Medical electrical
equipment- Part 1: General requirements for basic safety and
essentialperformance
EN60601-1-11:2010/ IEC 60601-1-11:2015 Medical electrical
equipment- Part 1-11: General requirements for basic safety and
essentialperformance - Collateral standard: Requirements for medical
electricalequipment and medical electrical systems used in the home
healthcareenvironment
EN60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical
equipment- Part 1-2: General requirements for basic safety and
essentialperformance - Collateral standard: Electromagnetic
compatibility- Requirements and tests
ENISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:
Requirementsand test methods for non-automated measurement type
EN1060-3:1997+A2:2009 Non-invasive sphygmomanometers -
Part3: Supplementary requirements for electro-mechanical blood
pressuremeasuring systems
EN1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test
proceduresto determine the overall system accuracy of automated
non-invasivesphygmomanometers
EN60601-1-6:2010/IEC 60601-1-6:2010+A1:2013 Medical
electricalequipment - Part 1-6: General requirements for basic safety
andessential performance - Collateral standard: Usability
EN62366:2008/ IEC 62366-1:2015 Medical devices - Application
ofusability engineering to medical devices
EN62304:2006/AC: 2008 / IEC 62304:2006 Medicaldevice
software- Software life-cycle processes
Riskmanagement
Labeling
Usermanual
GeneralRequirements
forSafety
Electromagnetic
compatibility
Performance
requirements
Clinicalinvestigation
Usability
Softwarelife-cycle
processes
Bio-compatibility
ISO10993-1:2009 Biological evaluation of medical devices- Part
1:Evaluation and testing within a risk management process
ISO10993-5:2009 Biological evaluation of medical devices -
Part5: Tests for in vitro cytotoxicity
ISO10993-10:2010 Biological evaluation of medical devices -
Part10: Tests for irritation and skin sensitization
ISO15223-1:2012 Medicaldevices.Symbolsto be used with
medicaldevice labels, labelling and information to be supplied. Part 1 :
Generalrequirements
IEC80601-2-30:2013 Medical electrical equipment- Part 2-30:
Particularrequirements for the basic safety and essential
performanceof automated non-invasive sphygmomanometers
ISO81060-2:2013 Non-invasivesphygmomanometers-Part 2:
Clinicalvalidation of automated measurement type
Guidanceand manufacturer’s declaration – electromagnetic emissions
RFemissions
CISPR11 Group1
ClassB
ClassA
Complies
Compliance
Harmonicemissions
IEC61000-3-2
Voltagefluctuations/
flickeremissions
IEC61000-3-3
RFemissions
CISPR11
Emissionstest Electromagneticenvironment - guidance
Thedevice is intended for use in the electromagn etic environment specified below. The customer or the
userof the device should assure that it is used in such an environment.
Thedevice uses RF energy only for its internal
function.Therefore, its RF emissions are very low
andare not likely to cause any interference in nearby
electronicequipment.
Thedevice is suitable for use in all establishments,
otherthan domestic and those directly connected to
thepublic low-voltage power supply network that
suppliesbuildings used for domestic purposes.
Guidanceand manufacturer’s declaration – electromagnetic immunity
Immunitytest
±8kV contact
±15kV air ±8kV contact
±15kV air
±2kV
powersupply lines:
line(s)to line(s): ±1 kV
line(s)to earth: ±2 kV
0%0.5 cycle
At0°, 45°, 90°, 135°,
180°,225°,270°and 315°
0% 1 cycle
and70% 25/30 cycles
Singlephase: at 0
0%300 cycle
30A/m
50Hz/60Hz
NOTE U
T
isthe a.c. mains voltage prior to application of the test level.
Compliancelevel
Electrostatic
discharge(ESD)
IEC61000-4-2
Electromagnetic
environment- guidance
30A/m
50Hz/60Hz
Powerfrequency
(50Hz/60Hz)
magneticfield
IEC61000-4-8
Voltagedips,
shortinterruptions
andvoltage
variationson
powersupply
inputlines
IEC61000-4-11
Electricalfast
transient/burst
IEC61000-4-4
Surge
IEC61000-4-5
input/outputlines:
±1kV
Thedevice is intended for use in the electromagnetic environment specified below. The customer or the
userof the device should assure that it is used in such an environment.
IEC60601 test level
Floorsshould be wood, concrete
orceramic tile. If floors are
coveredwith synthetic material,
therelative humidity should be at
least30%.
±2kV
powersupply lines:
100kHz repetition
frequency
line(s)to line(s): ±1 kV
100kHz repetition
frequency
Mainspower quality should be
thatof a typical commercial or
hospitalenvironment.
Mainspower quality should be
thatof a typical commercial or
hospitalenvironment.
Mainspower quality should be
thatof a typical commercial or
hospitalenvironment.
Powerfrequency magnetic fields
shouldbe at levels characteristic
ofa typical location in a typical
commercialor hospital
environment.
0%0.5 cycle
At0°, 45°, 90°, 135°,
180°,225°,270°and
315°
0% 1 cycle
and70% 25/30 cycles
Singlephase: at 0
0%300 cycle
Guidanceand manufacturer’s declaration – electromagnetic immunity
Immunitytest Compliance
level
IEC60601
Testlevel
ConductedRF
IEC61000-4-6
RadiatedRF
IEC61000-4-3
10V/m,80% Am
at1kHz
150kHz to
80MHz:
3Vrms
6Vrms(in ISM
andamateur
radiobands)
80%Am at 1kHz
Electromagneticenvironment - guidance
NOTE1 A t80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 T heseguidelinesmay not apply in all situations. Electromagnetic propagation is affected by
absorptionand reflection from structures, objects and people.
a
Fieldstrengths from fixed transmitters, such as base stations for radio (cellular / cordless)
telephonesand land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannotbe predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixedRF transmitters, an electromagnetic site survey should be considered. If the measured field
strengthin 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.
Overthe frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m .
b
Thedevice is intended for use in the electromagnetic environment specified below. The customer or the
userof the device should assure that it is used in such an environment.
150kHz to
80MHz:
3Vrms
6Vrms(in ISM
andamateur
radiobands)
80%Am at 1kHz
Portableand mobile RF communications
equipmentshould be used no closer to any part
ofthe device, including cables, than the
recommendedseparation distance calculated
fromthe equation appropriate for the frequency
ofthe transmitter.
Recommendedseparation distances:
d=0.35;
d=1.2
10V/m,80% Am
at1kHz
80MHz to 800 MHz:
d=1.2
800MHz to 2.7 GHz:
d=2.3
where,
Pisthemaximum
outputpower rating of the
transmitterin watts (W)
accordingto the
transmittermanufacturer,
disthe recommended
separationdistance in
meters(m). Field
strengthsfrom fixed RF
transmitters,as
determinedby an
electromagneticsite
survey,should be less
thanthe compliance level
ineach frequency range.
Interferencemay occur in
thevicinity of equipment
markedwith the following
symbol:
150kHz to 80 MHz 8 0MHz to 800 MHz 800 MHz to 2.7 GHz
Recommendedseparation distances between portable and mobile RF communications
equipmentand the device.
Ratedmaximum output
powerof transmitter
(W)
Separationdistance according to frequency of transmitter(m)
0.01
0.1
1
10
100
0.12 0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
=d =d 1.2 2.3=d
0.37
1.2
3.8
12
3.5
Thedevice is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled.The customer or the user of the device can help prevent electromagnetic interference by
maintaininga minimum distance between portable and mobile RF communications equipment
(transmittters)and the device as recommended below, according to the maximum output power of the
communicationsequipment.
Fortransmitters rated at a maximum output power not listed above, the recommended separation
distance
dinmetres (m) can be estimated using the equation applicable to the frequency of the
transmitter,where Pis the maximum output power rating of the transmitter in watts (W) according to the
transmittermanufacturer.
NOTE1 At80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE2 Theseguidelines may not apply in all situations. Electromagnetic propagation is affected by
absorptionand reflection from structures, objects and people.
FCCStatement
Thisdevice 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
interferencereceived, including interference that
maycause undesired operation.
CAUTIONS
• Whenusing this device, please pay attention to the following situation which may interrupt blood ow and inuence
bloodcirculation of the patient, thus cause harmful injury to the patient: connection tubing kinking too frequent and consecutive multiple
measurements;the application of the cu and its pressurization on any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is
present;inating the cu on the side of a mastectomy.
• Warning:Do not apply the cu over a wound;otherwise it can cause further injur y.
• Do not inatethe cu on the samb limb which other monitoring ME equipment is applied around simultaneously, because this could cause
temporaryloss of function of those simultaneously-used monitoring ME equipment.
• Onthe rare occasion of a fault causing the cu to remain fully inated during measurement, open the cu immediately.
• Prolongedhigh pressure (cu pressure > 300mmHg or constant pressure > 15mmHg for more than 3 minutes) applied to the arm
maylead to an ecchymosis.
• Pleasecheck that operation of the device does not result in prolonged impairment of patient blood circulation.
• Whenmeasurement, please avoid compression or restriction of the connection tubing.
• Thedevice cannot be used with HF surgical equipment at the same time.
• TheACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was clinically
investigatedaccording to the requirements of ISO 81060-2:2013.
• Toverify the calibration of the AUTOMATEDSPHYGMOMANOMETER, please contact the manufacturer.
• Thisdevice is contraindicated for any female who may be suspected of, or is pregnant. Besides providing inaccurate readings,
theeects of this device on the fetus are unknown.
• Toofrequent and consecutive measurements could cause disturbances in blood circulation and injuries. This unit is not suitable for continuous
monitoringduring medical emergencies or operations. Otherwise, the patient’s arm and ngers will become anaesthetic, swollen and even purple
dueto a lack of blood.
• Whennot in use, store the device with the adapter in a dry room and protect it against extreme moisture, heat, lint,
dustand direct sunlight. Never place any heavy objects on the storage case.
• Thisdevice may be used only for the purpose described in this booklet. The manufacturer cannot be held liable
fordamage caused by incorrect application.
Authorized Component
1.Please use the iProvèn authorized adapter. (not
included)
Guidance and manufactures - electromagnetic Immunity
Adapter
Model:KH0601000UW
Input:AC 100-240V
50/60Hz 0.4A Max
Output: 6V 1000mA
Test
Frequency
(MHz)
385 0.32 7
Thedevice is intended for use in the electromagnetic environment specified below. The customer or the
userof the device, should assure that it is used in such an environment.
NOTEIf necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna
andthe ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by
IEC61000-4-3.
RadiatedRF
IEC61000-4-3
(Test
specifications
for
ENCLOSURE
PORT
IMMUNITYto
RFwireless
communica-
tions
equipment)
Banda)
(MHz)
Servicea) Modulationb) Modulation b)
(W)
Distance(m)
IMMUNITY
TEST
LEVEL
(V/m)
380-390 TETRA
400
Pulse
modulationb)
18Hz
1.8
450 380-390
GMRS460，
FRS460
FMc) ± 5kHz
deviation1kHz
sine
20 .3 28
710 704-787
745
780
LTEBand
13,
17
Pulse
modulationb)
217Hz
0.20 .3 9
810
870
930
800-960
GSM
800/900,
TETRA800,
iDEN820,
CDMA850,
LTEBand5
Pulse
modulationb)
18Hz
20.32 8
1720
1845
1970
1700-
1990
GSM1800;
CDMA1900;
GSM1900;
DECT;
LTEBand1,
3,
4,25;UMTS
Pulse
modulationb)
217Hz
20.32 8
20.32 82450 2400-
2570
Bluetooth,
WLAN,
802.11
b/g/n,RFID
2450,LTE
Band7
Pulse
modulationb)
217Hz
5240
5240
5785
5100-
5800
WLAN
802.11
a/n
Pulse
modulationb)
217Hz
0.2 0.39
a)For some services, only the uplink frequencies are included.
b)The carrier shall be modulated using a 50% duty cycle square wave signal.
c)As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does
notrepresent actual modulation, it would be worst case.
TheMANUFACTURER should consider reducing the minimum separation distance, based on RISK
MANAGEMENT,and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced
minimumseparation distance. Minimum separation distances for higher IMMUNITY TEST LEVELS shall be
calculatedusing the following equation:
E=
WhereP is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY
TESTLEVEL in V/m.
Normal
Prehypertension
lessthan 120
90or higher
Higherthan 120
Higherthan 180
lessthan 80
lessthan 80
120-129
HighBlood Pressure
(hypertension)Stage 1
HighBlood Pressure
(hypertension)Stage 2
HypertensiveCrisis
(Emergencycare needed)
130-139
140or higher
80-89
and
and
or
or
and/or
Blood Pressure
Category Systolic mmHG (upper#) Diastolic mmHg (lower#)
Green
Yellow
Orange
Dark
Orange
Red

Warranty
This Limited Warranty covers any defects in materials or workmanship under normal use during the Warranty Period. iProvèn will
either replace the product or repair the product at no charge, using new or refurbished replacement parts.The Warranty Period of this
iProvèn product is 2 years from the date of purchase. A replacement product or product part assumes the remaining warranty of the
original product purchase. This LimitedWarranty does not cover batteries and packaging, nor any problem that is caused by conditions,
malfunctions, or damage not resulting from defects in material or workmanship.
To obtain warranty service, contact our customer support at www.iproven.com to determine the problem and the most
appropriate solution for your situation.
iProvèn owns and reserves the rights comprised in the copyright of this document. No part of this document may be changed, copied,
reproduced, or imitated in any form or by any means without prior written consent of iProvèn. All statements, information, and
recommendations in this document are provided“AS IS” without warranties, guarantees or representations of any kind, either express or
implied. The information in this document is subject to change without notice. iProvèn reserves the right of nal interpretation of this
document.
DISTRIBUTED BY
NETDIRECT DISTRIBUTION, LLC
9360 Federal Blvd
Denver , CO 80260
Phone: [phone]
HEADQUARTERS
Ebweg 12D
2991 LT Barendrecht
The Netherlands
Phone: [phone]
CAUTIONS
• This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in this booklet.
• The equipment is not AP/APG equipment and not suitable for use in the presence of a ammable anesthetic mixture with air of with oxygen or nitrous oxide.
• Warning: No servicing/maintenance while the ME equipment is in use.
• The patient is an intended operator.
• The patient can measure data under normal circumstances and maintain the device and its accessories according to the user manual.
• To avoid measurement errors, please avoid the condition of strong electromagnetic eld radiated interference signal or
electrical fast transient/burst signal.
• The blood pressure monitor, its adaptor, and the cu are suitable for use within the patient environment.
If you are allergic to polyester, nylon or plastic, please don’t use this device.
• During use, the patient will be in contact with the cu. The materials of the cu have been tested and found to comply with requirements
of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensization or irritation reaction.
• Adaptor is specied as a part of ME EQUIPMENT.
• If you experience discomfort during a measurement, such as pain in the arm or other complaints, press the START/STOP button to release the air immediately
from the cu. Loosen the cu and remove it from your arm.
• If the cu pressure reaches 40 kPa (300 mmHg), the unit will automatically deate. Should the cu not deate when pressures reaches 40 kPa (300 mmHg),
detach the cu from the arm and press the START/STOP button to stop ination.
• Before use, make sure the device functions safely and is in proper working condition. Check the device, do not use the device if it is damaged in any way.
The continuous use of a damaged unit may cause injury, improper results, or serious danger.
• Do not wash the cu in a washing machine or dishwasher!
• The service life of the cu may vary by the frequency of washing, skin condition, and storage state. The typical service life is 10000 times.
• It is recommended that the performance should be checked every 2 years and after maintenance and repair, by retesting at least the requirements in
limits of the error of the cu pressure indication and air leakage (testing at least at 50mmHg and 200mmHg).
• Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines.
• Manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions,etc.,
to assist to service personnel in parts repair.
CAUTIONS
• The plug/adapter plug pins insulates the device from the main supply. Do not position the device in a position where it is dicult to disconnect from
the supply mains to safely terminate operation of ME equipment.
• The operator shall not touch output of batteries /adapter and the patient simultaneously.
• Cleaning :Dust environment may aect the performance of the unit. Please use the soft cloth to clean the whole unit before
and after use. Don’t use any abrasive or volatile cleaners.
• The device doesn’t need to be calibrated within two years of reliable service.
• If you have any problems with this device, such as setting up, maintaining or using, please contact the SERVICE PERSONNEL
of iProvèn. Don’t open or repair the device by yourself in the event of malfunctions. The device must only be serviced, repaired and opened by
individuals at authorized sales/service centers.
• Please report to iProvèn if any unexpected operation or events occur.
• Keep the unit out of reach of infants, young children or pets to avoid inhalation or swallowing of small parts. It is dangerous or even fatal.
• Be careful to strangulation due to cables and hoses, particularly due to excessive length.
• At least 30 min required for ME equipment to warm from the minimum storage temperature between uses until it is ready for intended use. At least 30
min required for ME equipment to cool from the maximum storage temperature between uses until it is ready for intended use.
• This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS;
• Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations,
walkie-talkies can aect this equipment and should be kept at least a distance d away from the equipment. The distance d is caculated by the
MANUFACTURER from the 80 MHz to 5.8 GHz column of Table 4 andTable 9 of IEC 60601-1-2:2014, as appropriate.
• Please use ACCESSORIES and detachable partes specied/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or
danger to the user/patients.
• There is no luer lock connectors are used in the construction of tubing, there is a possibility that they might be inadvertently connected to
intravascular uid systems, allowing air to be pumped into a blood vessel.
• Please use the device under the environment which was provided in the user manual. Otherwise, the performance and lifetime of the device will be
impacted and reduced.