IPROVEN BPM-337 Blood Pressure Monitor Instruction Manual

BPM-337
Blood Pressure Monitor
Instruction Manual

BPM-337 Blood Pressure Monitor

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 off 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 fi 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
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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 diff 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 infl ating 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 diff 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 cuff exceeds 40 kPa (300 mmHg), the unit will automatically defl ate;
• If the unit doesn’t defl ate when exceeding the 40 kPa (300 mmHg), detach the cuff from the wrist and press the START/STOP button to stop infl ation;
• Do not use the monitor under conditions of strong electromagnetic fi elds;
• Electromagnetic fi 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 fl 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 specifi 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 eff ects on the fetus.
• If you are suff ering from arrhythmias such as atrial or ventricular premature heartbeats or atrial fi 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 cuff being infl ated for a prolonged time will lead to numb ness of wrist and fi 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 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

The LCD Display

during measurement
| Error| See Error Messages and FAQ section
| Memory| Indicating the memory mode and the number of the measurement
| Time| Hour: Minute (Month/Day/Year)
| Measurement units| Measurement unit of blood pressure (1mmHg=0.133kPa)

The Cuff Components
Component List:

1. PCBA;
2. Air Pipe;
3. Pump;
4. Valve;
5. Cuff.

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 confi 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 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.

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.

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 infl 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 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 wrist every time. Blood circulation may diff er from wrist to wrist so you can get a diff 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, 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. 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 confi rm.
5. “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 aff 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 different categories of the American Heart Association blood pressure classification as depicted in the chart below.

Blood Pressure Category| Systolic mm HG (upper#)| | Diastolic mm Hg (lower#)
---|---|---|---
Normal| less than 120| and| less than 80
Prehypertension| 120-139| or| 80-89
High Blood Pressure (hypertension) Stage 1| 140-159| or| 90-99
High Blood Pressure (hypertension) Stage 2| 160 or higher| or| 100 or higher
Hypertensive Crisis (Emergency care needed)| Higher than 180| or| Higher than 100

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 Messages and FAQ

new batteries
Batteries are inserted incorrectly.| Insert the batteries correctly
Low batteries| Display is dim cr display | Batteries are low.| Replace with new batteries
Error message| E 01 shows| The cuff is too tight or too loose.| Refasten the cuff and then measure again.
E 02 shows| The monitor detected motion,talking or the pulse is too poor while measuring.| Relax for a moment and then measure again.
E 03 shows| The measurement process does not detect the pulse signal.| Loosen the clothing on the wrist and then measure again.
E 04 shows
EE XX ,shows on the display.| The treatment of the measurement failed.
A calibration error occu red .(X0( can be some digital symbol,such as 01, 0 .etc., if this similar
situation appear, all belong to calibration
error.)| Relax for a moment and then measure again.
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.
“oUt ” shows| Out of measurement range.| Follow the instructions in user manual and measure again.
Power supply| 2xAAA batteries,3V **
---|---
Display mode| Digital LCD V.A.36mmx41mm
Measurement mode| Oscillographic testing mode
Measurement range| Rated cuff pressure:
OmmHg~300mmHg (OkPa-40kPa)
Measurement pressure: 40mmHg-230mmHg (5.3kPa-30.7kPa)
Pulse value: (40-199) beat/minute
Accuracy| Pressure: 5°C-40°Cwithin±3mmHg(0.4kPa)
Pulse value:±5%
Normal working condition| Temperature:5°C-40°C
Relative humidity: ≤85%RH
Atmospheric pressure: 86kPa to 106kPa
Storage & transportation condition| Temperature:-20°C to 60°C
Relative Humidity: 10% RH to 93% RH
Atmospheric pressure: 50PA to 106kPa
Measurement perimeter of the wrist| About 13.5cm-21.5cm
Net Weight| Approx.120g(Excluding the dry cells)
External dimensions| Approx.80mmx65mmx22mm
Attachment| 2xAAA batteries,user manual
Mode of operation| Continuous operation
Degree of protection| Type BF applied part
Protection against ingress of water| IP22:** The first number 2: Protected against solid foreign objects of 12,5mm 0 and greater. The second number: Protected against vertically falling water drops when enclosure titled up to 15°. Vertically falling drops shall have no harmful effects when the enclosure is titled at any angle up to 15° on either side of the vertical
Software version| Vo1
Device classification| Internally Powered ME Equipment

Important Symbols on the Monitor

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”

Complied European Standards List

Risk management| ISO 14971:2007 Medical devices — Application of risk management to medical devices
---|---
Labeling| ISO 15223-1:2012 Symbols for use in the labelling of medical devices
User manual| EN 1041:2008 Information supplied by the manufacturer of medical devices
General Requirements for Safety| IEC 60601-1:2005 Medical electrical equipment – Part 1:
General requirements for basic safety and essential performance IEC 60601-1-11:2010 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
Electromagnetic compatibility| IEC 60601-1-2: 2007 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance – Collateral standard:Electromagnetic compatibility – Requirements and tests
Performance requirements| IEC80601-2-30: 2009
Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers
Clinical investigation| ISO 81060-2:2009 Automatic Blood Pressure Monitor overall system Interventional accuracy of the testing process
Usability| IEC60601-1-6:2010 2010 Medical electrical equipment -Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability IEC 62366:2007 Medical devices – Application of usability engineering to medical devices
Software life-cycle processes| IEC 62304:2006 Medical device software – Software life cycle processes

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.
Do not store or use this Monitor with other electric equipment.
Manufacturer’s declaration on Electromagnetic Emissions for all ME Equipments and Sytem

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.
Emissions test| Compliance| Electromagnetic environment – guidance
RF emissions CISPR 11| Group 1| 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.
RF emissions CISPR 11| Class B| 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.
Harmonic emissions IEC 61000-3-2| Not applicable
Voltage fluctuations/ flicker emissions IEC 61000-3-3| Not applicable

Manufacturer’s declaration on Electromagnetic Immunity for all ME Equipments and Systems

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| IEC 60601 test level| Compliance level| Electromagnetic environment -guidance
Electrostatic discharge (ESD)
IEC 61000-4-2| ±6 kV contact
±8 kV air| ±6 kV contact
±8 kV air|
Electrical fast transient/burst
IEC 61000-4-4| ±2 kV for power supply lines
±1 kV for input/output lines| Not applicable| Floors should be wood, concrete or
ceramic tile. If floors are covered withsynthetic material, the
relative humidity should be at least 30%.
Surge IEC
61000-4-5| ±1 kV line(s) to line(s)
±2 kV line(s) to earth| Not applicable| Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11| <5% UT
(>95% dipinUr +)
for 0.5 cycle 40% UT
(60% dip in Ur)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dipinUy ss)
for 5 s| 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. 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.
Power frequency (50/60Hz)
magnetic field IEC 61000-4-8| 3A/m| 3A/m| Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

Manufacturer’s declaration on Electromagnetic Immunity for all ME Equipments and Systems that do not provide 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| IEC 60601 TEST LEVEL| Compliance level| Electromagnetic environment – guidance
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3| 3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz| Not applicable
3 V/m| 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
d =1,2√P
d = 1,2√P 80 MHz to 800 MHz
d = 2,3 √P 800 MHz to 2,5 GHz
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, ashould 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 At 80 MHz and 800 MHz, 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.
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.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

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

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
d=1,2√P| 80 MHz to 800 MHz
d=1,2√P| 800 MHz to 2.5 GHz
d=2,3√P.
0.01| 0.12| 0.12| 0.23
0.1| 0.38| 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 80MHz and 800MHz, 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.

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 final interpretation of this document.

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References

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