Blood Pressure Monitor

Blood Pressure Monitor
Instruction Manual
iProvèn BPM-634
Thank you for making iProvèn your top choice. Please read the instructions carefully in order to accurately and
safely utilize this equipment.
The BPM-634 measures the blood pressure and the heart rate and saves the results. It also enables transferring the measurement
using the Bluetooth connection. The BPM-634 offers real time and accurate readings that are as convenient as possible thanks
to the Oscillometric Measuring method. Blood pressure measurements may not be valid or accurate if they are not performed in
accordance with the instructions provided in this manual, so please keep these instructions handy for future reference.
You can also find the digital version of this manual on www.iproven.com
It is our passion to develop high quality products for home use. Our products are manufactured at the highest technical
standards of professional quality, durability, and consistency. They are also designed with elegant simplicity in mind, making them
easy to use at home.
To help you get the most from our products, we provide clear instructions with each device. The manual also includes helpful
information that contributes to your overall health awareness.
In order 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
Manual Version: 2.0
Issuing Date: 2018/01/03
©2017. All rights reserved.
iProvèn - Professional Care Brought Home
iProvèn is a Masena Invest brand
Intended use of the BPM-634 blood pressure monitor
Intended use of the BPM-634 blood pressure monitor
The BPM-634 is a digital monitor that is used for measuring blood pressure and heart rate by wrapping the cuff around arms of
different sizes, within 8¾˝ - 16½˝ (22 cm to 42 cm). The BPM-634 is intended for home use and for adults only.
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How this device works
The product 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 inflating the wrist cuff, the device detects the pressure
oscillations according to the beat-to-beat pulsatile and so it determines the systolic, diastolic pressure and the heart rate.
Irregular Heart Beat detection
The device is equipped with irregular heart beat detection, IHB. The algorithm of the device compares the longest and shortest
intervals of registered pulse waves (the time interval) and calculates the standard deviation. If the differences in the time intervals
are more than 25% you have an irregular heartbeat and the
sign will appear in the display. If the device detects irregular
heartbeat during consecutive measurements and you are following the correct procedure, please consult your doctor.
The unit should not be used for prolonged monitoring during medical emergencies or operations.
The cuff being inflated for a prolonged time will lead to numbness of wrist and fingers, causing anesthesia, pain and ecchymosis.
Use the device according to the instructions of this manual to guarantee an efficient performance and durability of the device.
The cuff complies with the requirements of ISO 10993-5:2009 and ISO 10993-10:2010.
The cuff does not cause any potential allergic reaction or contact injury.
There is no need for calibration during the two years of ‘guaranteed service’.
Components of the BPM-634
SYMBOL
Setting up the device
Preparing the device
The LCD display and the meanings of the symbols
DESCRIPTION
EXPLANATION
Systolic pressure
High blood pressure
Diastolic pressure
Low blood pressure
Pulse display
Pulse in beats per minute
Memory
Indicates it is in the memory mode and
the measurement number
kPa
mmHg
Measurement Unit of the blood pressure
(1kPa=7.5mmHg)
Measurement Unit of the blood pressure
(1mmHg=0.133kPa)
Low battery
Batteries are low and need to be replaced
Irregular heartbeat
Blood pressure monitor is detecting an
irregular heartbeat during measurement
Blood pressure
level indicator
Indicates the blood pressure level
Current Time
Year/Month/Day, Hour : Minute
Heartbeat
Blood pressure monitor is detecting a
heartbeat during measurement
Motion indicator
Indicates detected motion try to avoid
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Open the battery cover;
Insert the four AA batteries conform the right polarity;
Close the battery cover;
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Connect the cuff by inserting the air plug into the air jack
on the left side of the device.
1.
2.
3.
4.
5.
6.
7.
First make sure you set the time and data correctly so the device can register the results with the correct time;
With the monitor OFF, press SET. The time will now show in the display;
Hold the SET button for 3 seconds until the “Year” starts blinking;
Press or hold MEM to adjust the Year digits that are blinking on the display. Press SET to confirm;
Repeat step 2 for setting the Month & Day, Hour & Minutes;
Once the Minutes are set, the display will show “mmHg”. This is the standard measurement unit. Press SET to save;
Or press MEM to change to “kPa” and then press SET to save;
Once the measurement unit is set, the LCD will show “DONE”. Then the device will show the settings and then shut off.
Preparing the measurement
Wrapping the cuff
When wrapping the cuff around your upper arm, make sure that:
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The ART sign of the cuff is close to the artery;
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The cuff is positioned around an inch from the bent of your arm;
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The cuff is snug but not too tight. You have to be able to insert
one finger between the cuff and the arm.
(0.8 - 1.2 )
Taking a measurement
1.
Be seated in a quiet and comfortable room, with your arm resting on a flat surface;
2.
After wrapping the cuff (see “wrapping the cuff ” section), rest 3 minutes, keep your the palm of your hand upwards, your
back straight and breathe deeply for 5 or 6 times before starting the measurement;
3.
Press START to begin the measurement;
4.
The monitor will first calibrate to zero air pressure and then inflate the cuff. While inflating the measurements are made;
5.
When the measurement is completed the results will appear in the screen. The measurement is also saved in the memory.
Using the memory function
Tips for better accuracy
Deleting the records
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In case you want to delete your recorded measurements, please follow these steps:
1.
Make sure the monitor is inactive. If the monitor is not yet inactive, first deactivate it by pressing STOP;
2.
Press MEM to go to Memory;
3.
Press and hold the MEM button for 3 seconds;
4.
“DEL ALL” will start blinking. Press SET to confirm. (Or press STOP to cancel);
5.
“DEL DONE” will show, meaning the stored data is deleted. The device will shut off.
During the measurement do not move or speak and be seated in a silent room;
Do not cross your legs during the measurement;
Do not use the device in a toilet or while doing any sort of activity including talking or moving;
Do not use the device in a cold environment;
To get insight in the trend of your blood pressure, it is best to measure your blood pressure at about the same time(s) every day;
For accurate results, avoid using the device within 1 Hour after eating;
You shouldn’t measure immediately after drinking tea or coffee and after smoking;
Avoid measuring after 30 minutes of taking a shower or bath;
For an accurate and clear result, please measure the same arm every time;
As a rule of thumb: when you measure your left arm, position the hose in line with the index finger. For even higher accuracy,
make sure the ART sign on the cuff is closest to the artery. You can locate the artery by pressing 2 fingers 1 inch above the bend
of your elbow on the inside of your arm. The artery is where you can feel the pulse the strongest.
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Every measurement is automatically saved in the memory, with a maximum capacity of 60 measurements;
Make sure that the date and time are set correctly;
To view the recorded data press the MEM button while the monitor is inactive;
If the monitor is not yet inactive, first deactivate it by pressing STOP;
Use the buttons MEM for Up and Set for Down to read through the records.
Basic info about blood pressure
Error messages and FAQ
Systolic pressure means that the ventricles contract and pump out blood, increasing the blood pressure. The diastolic pressure
means that the ventricles relax so the blood pressure decreases.
PROBLEM SYMPTOM
No power
Display will not
light up.
AHA indicator
After each measurement an arrow indicates the corresponding AHA category color on the left of the display. The colors represent
the different categories of the American Heart Association blood pressure classification as depicted in the chart below.
Low
batteries
Display is dim or
show
E 01 shows
E 02 shows
Blood Pressure
Category
Green
Yellow
Orange
Normal
Prehypertension
High Blood Pressure
(hypertension) Stage 1
High Blood Pressure
Dark
Orange (hypertension) Stage 2
Hypertensive Crisis
Red
(Emergency care needed)
Systolic
mm HG (upper#)
less than 120
Diastolic
mm Hg (lower#)
and
less than 80
120-129
and
less than 80
130-139
or
80-89
140 or higher
or
90 or higher
Higher than 180 and/or Higher than 120
Changes in blood pressure
There are many factors that cause the
blood pressure to change. Weather,
emotions, stress, food, physical activities;
all these influence the variations in
the blood pressure. Bear in mind that
measuring in clinical settings tend to
cause the blood pressure to increase.
This is called “white coat effect”.
Error
message
E 03 shows
E 04 shows
EExx,shows on
the display.
Warning
message
“out ” shows
CHECK THIS
Important symbols on the monitor
REMEDY
Symbol for “THE OPERATION
GUIDE MUST BE READ”
Power supply
Batteries are exhausted. Replace with new batteries
Batteries are inserted
incorrectly.
Batteries are low.
Insert the batteries
correctly
Replace with new batteries
The cuff is too tight
or too loose.
Refasten the cuff and then
measure again.
The monitor
detected motion
while measuring.
Movement can affect the
measurement.Relax for a
moment and then
measure again.
The measurement
process does not
detect the pulse
signal.
Loosen the clothing on
the arm and then
measure again.
The treatment of the
measurement failed.
Relax for a moment and
then measure again.
A calibration error
occurred. (XX can
be some digital symbol,
such as 01, 02,etc., if
this similar situation
appear, all belong to
calibration error.)
Out of measurement
range
Retake the measurement.
If the problem persists,
contact the retailer or our
customer service
department for further
assistance.Refer to the
warranty for contact
information and return
instructions.
Relax for a moment.
Refasten the cuff and then
measure again. If the
problem persists, contact
your physician.
Display mode
Measurement mode
Measurement range
Accuracy
Normal working condition
Storage & transportation
condition
Measurement perimeter
of the upper arm
Weight
External dimensions
Attachment
Mode of operation
Degree of protection
Protection against
ingress of water
Device Classification
Software Version
Symbol for “MANUFACTURER”
Oscillographic testing mode
Rated cuff pressure:
0mmHg~299mmHg(0kPa ~ 39.9kPa)
Measurement pressure:
SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa)
DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa)
Pulse value: (40-199)beat/minute
Pressure:
5℃-40℃within±3mmHg(0.4kPa)
Pulse value:±5%
A temperature range of :+5°C to +40°C
A relative humidity range of 15% to 90%,
non-condensing, but not requiring a water
vapour partial pressure greater than 50 hPa
An atmospheric pressure range of :
700 hPa to 1060 hPa
Temperature:-20°C to +60°C
A relative humidity range of ≤ 93%,
non-condensing, at a water vapour pressure
up to 50hPa
SN
Symbol for “SERIAL NUMBER”
Symbol for “DIRECT CURRENT”
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “ENVIRONMENT
PROTECTION - Electrical waste
products should not be disposed of
with household waste. Please recycle
where facilities exist. Check with your
local authority or retailer for recycling
advice”
Symbol for “MANUFACTURE
DATE”
Symbol for “Recycle”
The Green Dot is the license
symbol of a European
network of industry-funded
systems for recycling the
packaging materials of
consumer goods.
Caution: These notes must be
observed to prevent any damage
to the device.
Electromagnetic compatibility measures
Please pay attention to the precautions of EMC
(Electromagnetic Compatibility) of this Monitor. The
Blood Pressure Monitor must be installed and used
according to the EMC information shown in this manual.
The device can be affected by portable and mobile RF
communication equipment.
Remove any devices that emit electromagnetic fields
such as mobile phones from nearby the device.
The Blood Pressure Monitor has been tested and
inspected to guarantee a proper performance.
Continuous operation
Type BF applied part
IP21 It means the device could protected against
solid foreign objects of 12.5mm and greater, and
protect against vertically falling water drops.
Battery Powered Mode:
Internally Powered ME Equipment
AC Adaptor Powered Mode: Class II ME Equipment
A01
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
IEC 61000-3-2
Compliance
Group 1
Class B
flicker emissions
Electromagnetic environment - guidance
The device uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.
The device is suitable for use in all establishments,
other than domestic and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
The device is intended for use in the electromagnetic environment specified below. The customer or the
user of the device should assure that it is used in such an environment
.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC61000-4-5
Class A
Voltage fluctuations/
IEC 61000-3-3
Do not store or use this Monitor with other electric
equipment.
Guidance and manufacturer’s declaration – electromagnetic immunity
Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The customer or the
user of the device should assure that it is used in such an environment.
Harmonic emissions
About 22cm~42cm
Approx.260g(Excluding the dry cells and cuff)
Manufacturer’s declaration on Electromagnetic Immunity for all ME Equipments and Systems
Complies
Voltage dips,
short interruptions
and voltage
variations on
power supply
input lines
IEC 60601 test level
±8 kV contact
±15 kV air
power supply lines:
±2 kV
Compliance level
±8 kV contact
±15 kV air
power supply lines:
±2 kV
input/output lines:
±1 kV
line(s) to line(s): ±1 kV
line(s) to earth: ±2 kV
100 kHz repetition
frequency
0% 0.5 cycle
At 0°, 45°, 90°, 135°,
180°,225°,270° and 315°
0% 1 cycle
and 70% 25/30 cycles
Single phase: at 0
0% 300 cycle
Electromagnetic
environment - guidance
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
line(s) to line(s): ±1 kV Mains power quality should be
that of a typical commercial or
hospital environment.
0% 0.5 cycle
Mains power quality should be
At 0°, 45°, 90°, 135°, that of a typical commercial or
180°,225°,270° and
hospital environment.
315°
0% 1 cycle
and 70% 25/30 cycles
Single phase: at 0
0% 300 cycle
IEC 61000-4-11
(50Hz/60Hz)
magnetic field
IEC 61000-4-8
NOTE
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
U T is the a.c. mains voltage prior to application of the test le vel.
The safe distances between portable and mobile RF communications
equipment, ME Equipments and Systems that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the
user of the device should assure that it is used in such an environment.
Immunity test
Conducted RF
IEC 61000-4-6
Mains power quality should be
that of a typical commercial or
hospital environment.
100 kHz repetition
frequency
Power frequency
Manufacturer’s declaration on Electromagnetic Immunity for all ME Equipments
and Systems that do not provide LIFE-SUPPORTING
Radiated RF
IEC 61000-4-3
IEC 60601
Test level
150 kHz to
80 MHz:
3 Vrms
6Vrms (in ISM
and amateur
radio bands)
80% Am at 1kHz
10V/m, 80% Am
at 1kHz
Compliance
level
150 kHz to
80 MHz:
3 Vrms
6Vrms (in ISM
and amateur
radio bands)
80% Am at 1kHz
10V/m, 80% Am
at 1kHz
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the device, including cables, than the
recommended separation distance calculated
from the equation appropriate for the frequency
of the transmitter.
Recommended separation distances:
d=0.35;
d=1.2
80 MHz to 800 MHz: where, Pis the maximum
output power rating of the
d=1.2
800 MHz to 2.7 GHz: transmitter in watts (W)
according to the
d=2.3
transmitter manufacturer,
d is the recommended
separation distance in
meters (m). Field
strengths from fixed RF
transmitters, as
determined by an
electromagnetic site
survey, should be less
than the compliance level
in each frequency range.
Interference may occur in
the vicinity of equipment
marked with the following
symbol:
NOTE 1 A
t 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 T
hese guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in 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.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m .
Recommended separation distances between portable and mobile RF communications
equipment and the device.
The device 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
maintaining a minimum distance between portable and mobile RF communications equipment
(transmittters) and the device as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output
power of transmitter
(W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz 8
d = 3.5
0 MHz to 800 MHz
FCC Statement
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.
Complied European Standards List
Risk management
EN ISO 14971:2012 / ISO 14971:2007 Medical devices Application of risk management to medical devices
Labeling
EN 980:2008 Symbols for use in the labelling of medical devices
ISO 15223-1:2012 Medical devices. Symbols to be used with
medical device labels, labelling and information to be supplied. Part 1 :
General requirements
User manual
General Requirements
for Safety
Electromagnetic
compatibility
EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical
equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
Performance
requirements
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:
Requirements and test methods for non-automated measurement type
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood
pressure measuring systems
IEC 80601-2-30:2013 Medical electrical equipment- Part 2-30:
Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers
800 MHz to 2.7 GHz
d = 1.2
d = 2.3
0.01
0.12
0.12
0.23
0.1
0.37
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
EN 1041:2008 Information supplied by the manufacturer of medical
devices
EN 60601-1:2006/ IEC 60601-1:2005+A1:2012 Medical electrical
equipment - Part 1: General requirements for basic safety and
essential performance
EN 60601-1-11:2010/ IEC 60601-1-11:2015 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
Clinical investigation
Software life-cycle
processes
Bio-compatibility
The device is intended for use in the electromagnetic environment specified below. The customer or the
user of the device, should assure that it is used in such an environment.
Radiated RF Test
Band a) Service a) Modulation b) Modulation b)
IEC61000-4-3 Frequency (MHz)
(W)
(Test
(MHz)
specifications
1.8
for
385
380-390 TETRA
Pulse
ENCLOSURE
400
modulation b)
PORT
18Hz
IMMUNITY to
GMRS 460,FM c) ± 5kHz
RF wireless
20
deviation 1kHz
450
380-390 FRS 460
communicasine
tions
710
704-787 LTE Band Pulse
equipment)
0.20
modulation b)
13,
745
217Hz
17
780
810
EN 60601-1-6:2010/IEC 60601-1-6:2010+A1:2013 Medical
electrical equipment - Part 1-6: General requirements for basic safety
and essential performance - Collateral standard: Usability
EN 62366:2008/ IEC 62366-1:2015 Medical devices - Application
of usability engineering to medical devices
EN 62304:2006/AC: 2008 / IEC 62304:2006 Medical device
software - Software life-cycle processes
ISO 10993-1:2009 Biological evaluation of medical devices- Part
1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
800-960
GSM
Pulse
800/900,
modulation b)
TETRA 800, 18Hz
iDEN 820,
CDMA 850,
LTE Band 5
17001990
GSM 1800; Pulse
CDMA 1900; modulation b)
GSM 1900; 217Hz
DECT;
LTE Band 1,
3,
4,25; UMTS
870
930
1720
1845
1970
2450
24002570
5240
51005800
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test
procedures to determine the overall system accuracy of automated
non-invasive sphygmomanometers
ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2:
Clinical validation of automated measurement type
Usability
Guidance and manufactures - electromagnetic Immunity
5240
Bluetooth, Pulse
modulation b)
WLAN,
217 Hz
802.11
b/g/n, RFID
2450, LTE
Band 7
WLAN
802.11
a/n
Pulse
modulation b)
217 Hz
Distance (m) IMMUNITY
TEST
LEVEL
(V/m)
0.32
7
.3
28
.3
9
2
0.32
8
2
0.32
8
2
0.32
0.2
0.39
Authorized Component
1. Please use the iProvèn authorized adapter. (not
included)
CAUTIONS
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8
5785
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna
and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by
IEC 61000-4-3.
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
not represent actual modulation, it would be worst case.
The MANUFACTURER should consider reducing the minimum separation distance, based on RISK
MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced
minimum separation distance. Minimum separation distances for higher IMMUNITY TEST LEVELS shall be
calculated using the following equation:
E=
Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY
TEST LEVEL in V/m.
Adapter
Model: KH0601000UW
Input: AC 100-240V
50/60Hz 0.4A Max
Output: 6V
1000mA
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When using this device, please pay attention to the following situation which may interrupt blood flow and influence
blood circulation of the patient, thus cause harmful injury to the patient: connection tubing kinking too frequent and consecutive multiple
measurements; the application of the cuff and its pressurization on any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is
present; inflating the cuff on the side of a mastectomy.
Warning: Do not apply the cuff over a wound;otherwise it can cause further injury.
Do not inflate the cuff on the samb limb which other monitoring ME equipment is applied around simultaneously, because this could cause
temporary loss of function of those simultaneously-used monitoring ME equipment.
On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff immediately.
Prolonged high pressure (cuff pressure > 300mmHg or constant pressure > 15mmHg for more than 3 minutes) applied to the arm
may lead to an ecchymosis.
Please check that operation of the device does not result in prolonged impairment of patient blood circulation.
When measurement, please avoid compression or restriction of the connection tubing.
The device cannot be used with HF surgical equipment at the same time.
The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was clinically
investigated according to the requirements of ISO 81060-2:2013.
To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer.
This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing inaccurate readings,
the effects of this device on the fetus are unknown.
Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries. This unit is not suitable for continuous
monitoring during medical emergencies or operations. Otherwise, the patient’s arm and fingers will become anaesthetic, swollen and even purple
due to a lack of blood.
When not in use, store the device with the adapter in a dry room and protect it against extreme moisture, heat, lint,
dust and direct sunlight. Never place any heavy objects on the storage case.
This device may be used only for the purpose described in this booklet. The manufacturer cannot be held liable
for damage caused by incorrect application.
CAUTIONS
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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 flammable 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 field radiated interference signal or
electrical fast transient/burst signal.
The blood pressure monitor, its adaptor, and the cuff 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 cuff. The materials of the cuff 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 specified 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 cuff. Loosen the cuff and remove it from your arm.
If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when pressures reaches 40 kPa (300 mmHg),
detach the cuff from the arm and press the START/STOP button to stop inflation.
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 cuff in a washing machine or dishwasher!
The service life of the cuff 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 cuff 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.
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CAUTIONS
Warranty
The plug/adapter plug pins insulates the device from the main supply. Do not position the device in a position where it is difficult 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 affect 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 affect 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 and Table 9 of IEC 60601-1-2:2014, as appropriate.
Please use ACCESSORIES and detachable partes specified/ 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 fluid 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.
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 Limited Warranty 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 final interpretation of this
document.
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