Iproven BPM-337BT User Manual

iProvèn BPM-337BT
High blood pressure
Low blood pressure
Measurement unit of blood pressure (1mmHg=0.133kPa)
Hour:Minute (Month/Day/Year)
SYMBOL DESCRIPTION EXPLANATION
Pulse in beats per minute
Blood pressure monitor is detecting an irregular heartbeat during measurement.
Low battery and please replace the batteries.
Blood Pressure Monitor
Instruction Manual
Manual Ver.: 3.0 Issuing Date: 2017/21/12 ©2017. All rights reserved.
Thank you for making iProvèn your top choice. Please read the instructions carefully in order to accurately and safely utilize this equipment.
The BPM-337BT measures the blood pressure and the heart rate and saves the results. It also enables transferring the measurement using the Bluetooth connection. The BPM-337BT o ers 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. Please keep these instructions handy for future reference. You can also  nd 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
iProvèn - Professional Care Brought Home
iProvèn is a Masena Invest Company
Intended use of the BPM-337BT blood pressure monitor
The BPM-337BT is a digital monitor that is used for measuring blood pressure and heart rate by cuffi ng the device around wrists of di erent sizes from 5 ˝-8½˝ (13.5cm to 21.5 cm). The BPM-337BT is intended for home use and for adults only.
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 in ating the wrist cu , 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. Measurements can be transferred to smart devices using the Bluetooth connection and the iProvèn Health app.
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 di erences in the time intervals are more than 25% you have an irregular heartbeat and the IHB 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.
CAUTIONS
• Adult-use ONLY;
• Non-invasive measuring and monitoring of arterial blood pressure;
• Use only on the WRIST!
• Consult your doctor about the use of this device;
• When the pressure on the cu exceeds 40 kPa (300 mmHg), the unit will automatically de ate;
• If the unit doesn’t de ate when exceeding the 40 kPa (300 mmHg), detach the cu from the wrist and press the START/STOP button to stop in ation;
• Do not use the monitor under conditions of strong electromagnetic  elds;
• Electromagnetic  elds will interfere with the signal and electrically fast transient/burst signal;
• The maximum temperature that the applied part can achieve is
42.5 ºC while the environmental temperature is 40 ºC;
• The device is not AP/APG equipment;
• It is not suitable for use in the presence of a  ammable anesthetic mixture with air (or oxygen, nitrous oxide);
• Keep the Unit OUT OF REACH of infants, children or pets since inhalation or swallowing of small parts is dangerous or even fatal;
• Use only accessories or detachable parts speci ed and authorized by the Manufacturer;
• This Device should NOT be used on females suspected of pregnancy or pregnant! It may provide inaccurate readings and can have e ec ts on the fetus.
• If you are su ering from arrhythmias such as atrial or ventricular premature heartbeats or atrial  brillation the measurement results can be incoherent. In this case please consult your physician about the results.
Extra notes on the device
• The unit should not be used for prolonged monitoring during medical emergencies or operations.
• The cu being in ated for a prolonged time will lead to numb ness of wrist and  ngers, causing anesthesia, pain and ecchymosis.
• Use the device according to the instructions of this manual to guarantee an effi cient performance and durability of the device.
• The cu complies with the requirements of ISO 10993-5:2009 and ISO 10993-10:2010.
• The cu 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-337BT
The Monitor Components
The LCD Display
Systolic
Blood Pressure
Diastolic
Blood Pressure
Low battery
AHA indicator
IHB Detector
Memory
Measurement units
Bluetooth icon
High blood pressure level
Low blood pressure level
Pulse in beats per minute
Pulse
Low battery, please replace the batteries
Indicating the AHA category of the
Indicating the AHA category of the measurement
measurement
Blood pressure monitor is detecting an irregular heartbeat during measurement
See Error Messages and FAQ
See Error Messages and FAQ section
Error
Indicating the memory mode and the
Indicating the memory mode and the
number of the measurement
number of the measurement
Hour: Minute (Month/Day/Year)
Time
Measurement unit of blood pressure (1mmHg=0.133kPa)
Indicates when Bluetooth is active
The Cuff Components
Component List:
1. PCBA;
2. Air Pipe;
3. Pump;
4. Valve;
5. Cuff.
CUFF (Type BF applied part)
BATTERY COMPARTMENT
How to Install and Replace Batteries:
1. Open the battery cover
2. Insert the two AAA batteries conform the right polarity
3. Close the battery cover
Setting Up the Device
Firstly, make sure you set the time and data correctly so the device can register the results with the correct time.
1. With the monitor OFF, press and hold the SET button for 3 seconds. It will enter the SETTINGS Mode.
2. Press or hold the MEM button to adjust the Hour digits that are blinking on the display. Press SET to con rm.
3. Repeat step 2 for setting the Minutes; Month; Day and Year.
4. Press SET one more time to select the desired measurement unit. Probably “mmhg”.
5. Once the Year is 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.
6. Once the measurement unit is set, the LCD will show “DONE” and the device will shut o .
Preparing the measurement
Before tying the cu to your wrist, make sure you remove all accessories from the wrist (bracelets, watch, etc.). Use the device on the wrist that doesn’t have poor circulation.
1. Roll up the sleeve to reveal the skin of the wrist.
2. Make sure to tie the cu to 0.4”-0.6” (1-1.5cm) from your wrist joints.
3. Tie the cu to your wrist and keep the palm facing up.
4. Tie the cu to your wrist tightly but not painfully.
5. Place your elbow on a table and make sure that the wrist is at the same level with your heart.
6. Rest 3 minutes; keep your palm upwards, back straight and breathe deeply for 5 or 6 times before starting the measurement.
Taking a measurement
1. After resting press the Start Button and the measuring procedure will start.
2. First the measured air pressure will calibrate to zero and then the device will in ate and start reading the blood pressure and heart rate.
3. When the measurement is completed the results will appear in the screen. The measurement is also saved in the memory.
Tips and Timing
• Make sure you do not move or speak and that you are in a
silent room during a measurement.
• 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 co ee
and after smoking.
• Avoid measuring after 30 minutes of taking a shower or bath.
• For an accurate and clear result, please measure the same wrist every time. Blood circulation may di er from wrist to wrist so you can get a di erent result when you change wrists.
Connecting with a Smartphone
The iProvèn Health app can help you keep track of your data and remember you to take a new measurement. First download the app “iProvèn Health” from the iOS App Store or Google Play Store.
New users will be guided through the Connect Device section of the app. If you already used the app before, enter this section from the Settings menu. Select BPM-337BT and follow the instructions.
Enter pairing mode
Out of measurement range.
Failure of pairing up your monitor with your mobile device.
Guidance and manufacturer’s declaration – electromagnetic emissions
RF emissions
CISPR 11
Group 1
Class B
Not applicable
Not applicable
Compliance
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
IEC 61000-3-2
Voltage fluctuations/
flicker emissions IEC
61000-3-3
RF emissions
CISPR 11
Emissions test 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, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Guidance and manufacturer’s declaration – electromagnetic immunity
IMMUNITY test
±6 kV contact ±8 kV air
±6 kV contact ±8 kV air
±2 kV for power supply lines
Not applicable
±1 kV line(s) to line(s)
±2 kV line(s) to earth
<5% U
T
(>95% dip in UT) for 0.5 cycle
40% U
T
(60% dip in UT) for 5 cycles
70% U
T
(30% dip in U
T
)
for 25 cycles
<5% U
T
(>95% dip in UT) for 5 s
3A/m
NOTE UT is the a.c. mains voltage prior to application of the test level.
IEC 60601 test level Compliance level
Electrostatic discharge (ESD) IEC 61000-4-2
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%
.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
3A/m
Power frequency
(50/60Hz) magnetic field
IEC 61000-4-8
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11
Electrical fast transient/burst IEC 61000-4-4
Surge IEC 61000-4-5
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
±1 kV for input/output lines
Not applicable
Not applicable
Mains power quality should be that of a typical commercial or hospital environment
.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
b
Guidance and manufacturer’s declaration – electromagnetic immunity
IMMUNITY test
Not applicable
3 V/m
Compliance level
IEC 60601 TEST LEVEL
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
3 V/m 80 MHz to
2.5 GHz
3 Vrms 150 kHz to 80 MHz
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 applicable to the frequency of the transmitter.
Recommended separation distance
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.
where
P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (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.
a
b
Interference may occur in the vicinity of equipment marked with the following symbol:
P
=d
P
=d
80 MHz to 800 MHz
P
=d 2,3
800 MHz to 2,5 G Hz
1,2
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 broad-cast 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.
1,2
To get the monitor ready for pairing up with the App, please follow these steps:
• First make sure the monitor is inactive; press the start/stop
button if needed.
• Hold the START/STOP button for 3 seconds until a moving
[ ] sign appears in the display.
• The app will give you a notication when the connection is
• successfully established and the moving display of the monitor
will show a static [ ] sign.
The iProvèn Health app will give you more instructions and information about how to use monitor together with the app.
To check the compatibility of your
smartphone go to:
https://www.iproven.com/pages/compatible-devices
Using the memory function
• Make sure that the date and time is set correctly.
• Every measurement is automatically saved in the memory, with a maximum capacity of 60 measurements;
• To view the recorded data press the MEM button while the monitor is inactive. If the monitor is not yet inactive, rst deactivate it by pressing the start/stop button.
• Use the buttons MEM for Up and Set for Down to read through the records.
Deleting the records
In case you want to delete your recorded measurements, please follow these steps:
1. Make sure the monitor is inactive; press START/STOP if needed.
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 conrm.
5. “DEL DONE” will show, meaning the stored data is deleted. The device will shut o.
Keeping the device safe
Please make sure to place the device away from the sun. Store it in a dry place. When you want to clean the device, you should use a dry cloth. Do not place it in water or clean it with wet cloths. Also, be careful not to shake or throw the device. For a better performance, keep it in a room with stable temperature and away from dust. The cu should not be cleaned as it may aect the accuracy of the reading
Basic info about Blood Pressure
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.
AHA indicator
After each measurement an arrow indicates the corresponding category color on the left of the display. The colors represent the dierent categories of the american heart association blood pressure classication as depicted in the chart below.
Blood Pressure
Category
Green
Normal
Yellow
Prehypertension
High Blood Pressure
Orange
(hypertension) Stage 1
High Blood Pressure
Dark
Orange
(hypertension) Stage 2
Hypertensive Crisis
Red
(Emergency care needed)
Changes in blood pressure
There are many factors that cause the blood pressure to change. Weather, emotions, stress, food, physical activities; all these inuence 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 eect”.
Systolic
mm HG (upper#)
less than 120
120-129
130-139
140 or higher
Higher than 180
and
and
or
or
and/or
Diastolic
mm Hg (lower#)
less than 80
less than 80
80-89
90 or higher
Higher than 120
Error Messages and FAQ Important Symbols on the Monitor Complied European Standards List Electromagnetic Compatibility Measures
Please pay attention to the precautions of EMC (Electromagnetic
PROBLEM SYMPTOM CHECK THIS REMEDY
Display will not
No power
light up.
Display is dim or
Low
display
batteries
E 01 shows
E 02 shows
E 03 shows
E 04 shows
Error message
EE XX,shows on the display.
“oUt ” shows
“E 12 ” shows
Batteries are exhausted.
Batteries are inserted incorrectly.
Batteries are low.
The cuff is too tight or too loose.
The monitor detected motion,talking or the pulse is too poor while measuring.
The measurement process does not detect the pulse signal.
The treatment of the measurement failed.
A calibration error occurred.
be some digital symbol,such as 01, 02,etc., if this similar situation appear, all belong to calibration error.)
(XX can
Replace with new batteries
Insert the batteries
correctly
Replace with new batteries
Refasten the cuff and then measure again.
Relax for a moment and then measure again.
Loosen the clothing on the wrist and then measure again.
Relax for a moment and then measure again.
Retake the measurement. contact the retailer or our If the problem persists, customer service department for further assistance.Refer to the warranty for contact information and return instructions.
Follow the instructions in user manual and measure again.
Please check below items:
-Bluetooth is ON.
-App Collector is ON.
-Both devices are within the transmission distance of Bluetooth.
Power supply
Display mode
Measurement mode
Measurement range
Accuracy
Normal working condition
Storage & transportation
condition
Measurement perimeter
of the wrist
2*AAA batteries
Digital LCD V.A.36mmx41mm
Oscillographic testing mode
Pressure: 0kPa-40kPa(0mmHg-300mmHg)
pulse value:(40-199)beat/minute
Pressure:
5
-40within±0.4kPa(3mmHg)
pulse value:±5%
Temperature:5 to 40
Relative humidity: ≤85%RH
Atmospheric pressure: 86kPa to 106kPa
Temperature:-20 to 60
Relative humidity: 10%RH to 93%RH
Atmospheric pressure: 50kPa to 106kPa
About 13.5cm-21.5cm
Net Weight Approx.120g(Excluding the dry cells)
External dimensions
Attachment
Mode of operation
Degree of protection
Protection against ingress of water
Software version
Device classification
2*AAA batteries,user manual
Continuous operation
Type BF applied part
IP22
V01
Internally Powered ME Equipment
Symbol for “THE OPERATION GUIDE MUST BE READ”
Symbol for “Including RF transmitter”
Symbol for “MANUFACTURE DATE”
Caution: These notes must be observed to prevent any damage to the device.
Symbol for “TYPE BF APPLIED PAR TS”
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 “DIRECT CURRENT
Risk Management
Labeling
User Manual
Generl Requirements for Safety
Non-invasive Sphygmomanometers General Requirements
Electromagnetic Compatibility
ISO 14971:2007
EN 980:2008
ISO 15223-1:2012
EN 1041:2008
IEC 60601-1:2005
IEC 80601-2-30:2009
AASI/AAMI SP10:2002/A1:2003/A2:2006/R)2008
IEC 60601-1-2:2007
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 aected by portable and mobile RF communication equipment.
Remove any devices that emit electromagnetic elds such as mobile phones from nearby the device.
The Blood Pressure Monitor has been tested and inspected to guarantee a proper performance.
Do not store or use this Monitor with other electric equipment.
Manufacturer’s declaration on Electromagnetic Emissions for all ME Equipments and Sytem
Manufacturer’s declaration on Electromagnetic Immunity for all ME Equipments and Systems
Manufacturer’s declaration on Electromagnetic Immunity for all ME Equipments and Systems that do not provide LIFE-SUPPORTING
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