Blood Pressure Monitor

iProvèn BPM-337
Intended use of the BPM-337 blood pressure
monitor
Blood Pressure Monitor
Instruction Manual
Thank you for making iProvèn your top choice. Please read the
instructions carefully in order to accurately and safely utilize this
equipment.
The BPM-337 measures the blood pressure and the heart rate
and saves the results. The BPM-337 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. Please
keep these instructions handy for future reference. You can also
find the digital version of this manual on www.iproven.com
How this device works
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.
Irregular Heart Beat detection
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 Ver.: 2.3
Issuing Date: 2017/10/14
©2017. All rights reserved.
The BPM-337 is a digital monitor that is used for measuring blood
pressure and heart rate by cuffing the device around wrists of
different sizes from 5 ˝-8½˝ (13.5cm to 21.5 cm). The BPM-337 is
intended for home use and for adults only.
iProvèn - Professional Care Brought Home
iProvèn is a Masena Invest Brand
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.
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 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 cuff exceeds 40 kPa (300 mmHg),
the unit will automatically deflate;
• If the unit doesn’t deflate when exceeding the 40 kPa (300 mmHg),
detach the cuff from the wrist and press the START/STOP button
to stop inflation;
• Do not use the monitor under conditions of strong
electromagnetic fields;
• Electromagnetic fields 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 flammable 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 specified 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 effects on the fetus.
• If you are suffering from arrhythmias such as atrial or ventricular
premature heartbeats or atrial fibrillation the measurement results
can be incoherent. In this case please consult your physician about
the results.
Extra notes on the device
The LCD Display
The Cuff Components
Component List:
1. PCBA;
2. Air Pipe;
3. Pump;
4. Valve;
5. Cuff.
• 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 numb
ness 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-337
The Monitor Components
Setting Up the Device
CUFF
(Type BF applied part)
BATTERY
COMPARTMENT
SYMBOL DESCRIPTION EXPLANATION
Systolic
Blood Pressure
High blood
level
High
bloodpressure
pressure
Diastolic
Blood Pressure
Low blood
level
Low
bloodpressure
pressure
Pulse
How to Install and Replace
Batteries:
and please
replace
batteries.
Low battery,
please replace
thethe
batteries
Low battery Low battery
AHA indicator
IHB Detector
Indicating the AHA category of the
Indicating
the AHA category of the measurement
measurement
Blood
pressure
monitor
is detecting
an
Blood pressure
monitor
is detecting
an
irregular heartbeat
during
measurement
irregular
heartbeat
during
measurement.
Error
See
SeeError
ErrorMessages
Messagesand
andFAQ
FAQ section
Memory
Indicating
Indicatingthe
thememory
memorymode
modeand
andthe
the
number
numberofofthe
themeasurement
measurement
Time
Measurement units
Hour:Minute
(Month/Day/Year)
Hour: Minute (Month/Day/Year)
Measurement
unit
of blood
pressure
Measurement unit
of blood
pressure
(1mmHg=0.133kPa)
(1mmHg=0.133kPa)
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 confirm.
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 off.
Preparing the measurement
Before tying the cuff 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.
Pulse ininbeats
perper
minute
Pulse
beats
minute
1. Open the battery cover
2. Insert the two AAA batteries conform the right polarity
3. Close the battery cover
•
•
1. Roll up the sleeve to reveal the skin of the wrist.
2. Make sure to tie the cuff to 0,4”-0,6” (1-1.5cm) from
your wrist joints.
3. Tie the cuff to your wrist and keep the palm facing up.
4. Tie the cuff 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.
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 differ from wrist to wrist so you
can get a different result when you change wrists.
Using the memory function
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 inflate 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 coffee
and after smoking.
•
•
•
•
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, first
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.
2.
3.
4.
5.
Make sure the monitor is inactive; press START/STOP if needed.
Press MEM to go to Memory.
Press and hold the MEM button for 3 seconds.
“DEL ALL” will start blinking. Press SET to confirm.
“DEL DONE” will show, meaning the stored data is deleted. The
device will shut off.
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
cuff should not be cleaned as it may affect 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
different categories of the American Heart Association blood
pressure classification as depicted in the chart below.
Blood Pressure
Category
Systolic
mm HG (upper#)
Normal
less than 120
120-139
Prehypertension
Important Symbols on the Monitor
Measurement range
Accuracy
and
less than 80
Measurement perimeter
of the wrist
or
80-89
High Blood Pressure
(hypertension) Stage 2
160 or higher
or
100 or higher
Higher than 180
or
Higher than 100
or
90-99
Symbol for “THE OPERATION
GUIDE MUST BE READ”
Power supply
Display mode
Measurement mode
Normal working condition
140-159
Complied European Standards List
ISO 14971:2007
Diastolic
mm Hg (lower#)
High Blood Pressure
(hypertension) Stage 1
Hypertensive Crisis
(Emergency care needed)
Error Messages and FAQ
Storage & transportation
condition
Net Weight
External dimensions
Attachment
Mode of operation
Degree of protection
Digital LCD V.A.36mmx41mm
Oscillographic testing mode
Rated cuff pressure:
0mmHg~300mmHg (0kPa - 40kPa)
Measurement pressure: 40mmHg-230mmHg
(5.3kPa-30.7kPa)
Pulse value: (40-199) beat/minute
Pressure:
5℃-40℃within±3mmHg(0.4kPa)
Pulse value:±5%
Temperature:5℃-40℃ Relative humidity: ≤85%RH
Symbol for “MANUFACTURE
DATE”
Caution: These notes must be
observed to prevent any damage
to the device.
Symbol for Serial Number
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 “DIRECT CURRENT”
ISO 15223-1:2012
IEC 60601-1:2005
IEC 60601-1-11:2010
About 13.5cm-21.5cm
Approx.120g(Excluding the dry cells)
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.
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
The safe distances between portable and mobile
RF communications equipment, ME Equipments
and Systems that are not LIFE-SUPPORTING
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.
Do not store or use this Monitor with other electric equipment.
IEC80601-2-30: 2009
Particular requirements for the basic safety and
essential performance of automated noninvasive
sphygmomanometers
Manufacturer’s declaration on Electromagnetic Emissions for all ME
Equipments and Sytem
Type BF applied part
ISO 81060-2:2009
IEC 62366:2007
IEC 62304:2006
Protection against
ingress of water
FCC Statement
Software version
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.
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”.
Device classification
Internally Powered ME Equipment
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.
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.
IEC60601-1-6:2010
Continuous operation
Warranty
To obtain warranty service, contact our customer support at
www.iproven.com to determine the problem and the most
appropriate solution for your situation.
IEC 60601-1-2: 2007
Atmospheric pressure: 86kPa to 106kPa
Temperature:-20℃ to 60℃
Relative Humidity: 10% RH to 93% RH
Atmospheric pressure: 50PA to 106kPa
Electromagnetic Compatibility Measures
DISTRIBUTED BY
NETDIRECT DISTRIBUTION, LLC
9360 Federal Blvd
Denver , CO 80260
HEADQUARTERS
Ebweg 12D
2991 LT Barendrecht
The Netherlands
Phone: 1-503-974-0913
Phone: +31 (0)84-8838876
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