Iproven BPM-337 User Manual

iProvèn BPM-337

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.: 2.3
Issuing Date: 2017/10/14
©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-337 measures the blood pressure and the heart rate
and saves the results. The BPM-337 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 Brand

Intended use of the BPM-337 blood pressure
monitor

The BPM-337 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-337 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.

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 ects 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-337

The Monitor Components

The LCD Display The Cuff Components

Component List:

1. PCBA;

2. Air Pipe;

3. Pump;

4. Valve;

5. Cuff.

Systolic

High blood pressure level

Blood Pressure

Diastolic

Blood Pressure

Low battery

AHA indicator

IHB Detector

Memory

Measurement units

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)

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

CUFF
(Type BF applied part)

BATTERY
COMPARTMENT

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.

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

Normal less than 120 less than 80

Prehypertension

High Blood Pressure

(hypertension) Stage 1

High Blood Pressure

(hypertension) Stage 2

Hypertensive Crisis

(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#)

140-159

160 or higher

Higher than 180

mm Hg (lower#)

and

or

or

or

Higher than 100

or

Diastolic

80-89120-139

90-99

100 or higher

Error Messages and FAQ Important Symbols on the Monitor Complied European Standards List

ISO 14971:2007

Power supply

Display mode

Measurement mode Oscillographic testing mode

Measurement range

Accuracy

Normal working condition

Storage & transportation

condition

Measurement perimeter

of the wrist

Net Weight

External dimensions

Attachment

Mode of operation

Degree of protection

Protection against
ingress of water

Software version

Device classification

Digital LCD V.A.36mmx41mm

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

Atmospheric pressure: 86kPa to 106kPa

Temperature:-20℃ to 60℃
Relative Humidity: 10% RH to 93% RH

Atmospheric pressure: 50PA to 106kPa

About 13.5cm-21.5cm

Approx.120g(Excluding the dry cells)

Continuous operation

Type BF applied part

Internally Powered ME Equipment

Symbol for “THE OPERATION
GUIDE MUST BE READ”

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

IEC 60601-1-2: 2007

IEC80601-2-30: 2009

Particular requirements for the basic safety and
essential performance of automated noninvasive
sphygmomanometers

ISO 81060-2:2009

IEC60601-1-6:2010

IEC 62366:2007

IEC 62304:2006

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 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

The safe distances between portable and mobile
RF communications equipment, ME Equipments
and Systems that are not LIFE-SUPPORTING

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.

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 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 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]