IProven BPM-617 Blood Pressure Monitor Instruction Manual

IProven BPM-617 Blood Pressure Monitor Instruction Manual

Thank you for choosing iProven. Please read the instructions carefully in order to accurately and safely utilize this device. The BPM-617 measures blood pressure and heart rate and saves the results. It offers real-time clinically accurate readings that are simple and easy to read thanks to the Oscillometric Measuring method. This method measures blood pressure while the cuff is inflating thereby offering fast and accurate results. The inflation stops once the maximum blood pressure measurement has been achieved.

This avoids any discomfort or excessive squeezing of the wrist. Blood pressure measurements may be invalid or inaccurate if they are not performed in accordance with the instructions provided in this manual. Please keep this manual handy for future reference. You can also find the digital version on www.iproven.com

Intended use of the BPM

The BPM-617 is an upper arm digital monitor that is used for measuring blood pressure and heart rate with an arm circumference ranging from 8 ¾” – 16 ½” (22cm to 42cm). The device is intended for home use and adults only. The cuff should be maintained at the same level as the heart.

Special features

The BPM-617 comes with a user memory feature that can save up to 250 measurements for two different users (500 total), aside from a guest mode. You can sync your device with the app, to store an unlimited number of measurements. The device provides an average of the last three readings taken within 30 minutes so that you can keep track of your health and check for hypertension. Upon completing a new measurement, it will also display your prior measurement for an easy instant comparison of readings. The voice broadcast mode (which can be switched on or off) makes it easy to know your results without having to check the screen.

The large, 5.7” wide, high-contrast monitor screen and backlit dis-play help read results easily, even in the dark. The device is FDA-ap-proved and comes with a WHO indicator and a five-year warranty. It is also one of the quieter devices with a noise level of less than 48dB.

Choose your power supply
This device can be used either with included batteries OR an AC adapter.

1. Battery mode: Use 4 AA batteries as indicated
2. AC Adapter mode: Use the adapter cable included in the box with a 5V–1A charger

Note – The adapter cannot be used to charge or recharge the batteries

Installing the batteries

1. Open the battery cover.
2. Insert four AA batteries as per the symbols in the battery compartment.
3. Close the battery cover.

Setting the date and time

Firstly, ensure you set the time and date correctly so the device can record the results with the correct details. You can also choose whether to keep the voice mode on or off.

1. With the monitor OFF, press and hold the SET button. It will display the Bluetooth symbol
2. Press the SET button again it will enter voice setting mode. You will hear “Voice on” or “Voice off”.
3. Press the MEM button to change it on or off and to increase the voice volume. Select the SET but-ton to confirm the voice setting.
4. Press the MEM button to switch the date format between month/day/year and day/month/year.
5. Press the SET button to confirm the date format, then the year will flash. Press the MEM button to change the year and SET to confirm.
6. Repeat step 4 for setting the date, month, and time.
7. After completing the settings, the LCD will display DONE and it will turn off.

Using the app
Our device works perfectly well even without an app. If you would like to use it with the app, please follow the instructions in the insert provided in the box.

Setting the user ID
There are 3 user IDs. User 1 and user 2, with memory storage of 250 readings each, and a guest user with no memory space.

1. When the display is off, press the SET button and the user ID will show. Press it again to switch between the users – user 1, 2 or guest.
2. Press the START/STOP button to confirm the user ID and then proceed to your measurement.

Before using your device
For an accurate result and the best insight into your blood pressure pat-tern, please measure using the same arm every time. It is recommended to use the left arm which has a better blood flow.

• Take your blood pressure at the same time(s) every day.
• Do not use the device in a cold environment.
•  Avoid hot drinks, caffeine, tobacco, food, alcohol, and strenuous exercises at least 30 minutes before taking your blood pressure.
•  Empty your bladder before taking your measurement.

Preparing the measurement
Before a measurement sit down and relax for 3 minutes. Let your blood pressure stabilize.

• Make sure you remove all accessories from the wrist and arm (bracelets, watch, etc) before strapping the cuff to your arm.
• Roll up your sleeve to reveal the skin of your upper arm and ensure your sleeve isn’t too tight.
• Hold your arm with your palm facing up and slide the cuff onto your upper arm approximately one inch above the bend in your elbow.
• Position the tube off-center toward the inner side of the arm in line with the little finger. Or position the artery mark on the cuff over the main artery.
• Fasten the cuff to your arm tightly but not painfully. There should be a one-finger space between the cuff and your skin.
• Ensure that your test arm is resting on a flat surface, with your palm facing up.
• Sit comfortably with your back straight and supported.
• Keep your feet flat on the floor and do not cross your legs.

Taking a measurement

1. Breathe slowly 5 times and press the START/STOP button to begin the measurement. Keep your arm still.
2. First, the measured air pressure will calibrate to zero and then the cuff will inflate and start reading the blood pressure and heart rate.
3. The symbol should indicate meaning the cuff is cor-rectly secur 2ed. If the flashes that means there’s too much movement and you need to hold your arm still.
4. When the measurement has been completed, the results will appear on the screen. The measurement is also saved in the memory.
5. Remove the cuff and switch off the monitor.

Understanding the results

Upon completing your measurement, you will see on the display the date and time of your reading, your systolic pressure, diastolic pressure, heart rate, WHO blood pressure color indication, user 1, 2 or guest who’s taking the measurement, if you have an irregular heartbeat (See “Irregular Heartbeat” section for more) and details of your prior measurement.

Basic info about blood pressure
Systolic pressure means that the ventricles contract and pump out blood, increasing the blood pressure. This is sometimes referred to as the “higher number”. The diastolic pressure means that the ventricles relax so the blood pressure decreases. This is sometimes referred to as the “lower number”.

WHO indicator
After each measurement, the indicator shows the corresponding cate-gory color on the right of the display. The colors represent the different categories of the World Health Organisation blood pressure classifica-tion as depicted in the chart. The indicator helps you quickly interpret the results of the measurement. World Health Organization(WHO) and International Society of Hypertension(ISH)

Blood Pressure            Systolic                           Diastolic

Category            mmHg (upper#)             mmHg (lower#)

Optimal| less than 120| And| less than 80
Normal| 120-129| And| 80-84
High normal| 130-139| Or| 85-89
Mild hypertension| 140-159| Or| 90-99
Moderate hypertension| 160-179| And/Or| 100-109
Severe hypertension| Higher than 180| And/or| Higher than 120

Irregular heartbeat
The device is equipped with irregular heartbeat 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 on the display. If the device detects irregular heartbeat during consecutive measure-ments and you are following the correct procedure, please consult your doctor.

Changes in blood pressure
There are many factors that cause fluctuations in blood pressure. Weather, emotions, stress, food, and physical activities, all these cause variations in blood pressure. Bear in mind that measuring in clinical settings tends to cause blood pressure to increase. This is called the
“white coat effect”.

Using the memory function
Make sure that the date and time are set correctly. (See “Setting up the device” section)

• Every measurement is automatically saved in the memory. It has a maximum capacity of 500 (250 x 2 users) measurements. To view the recorded data press the MEM button while the monitor is inactive.
• Once the button is pressed, one of the user symbols starts blin-king. To switch to the other user, press the SET button.
• It will display the average value of the last 3 records first (if taken within a 30-minute period) and indicated by the AVG symbol.
• Use the MEM and SET buttons to go through the previous records.
• Note: The most recent record is shown first followed by the previous measurements.

Deleting the records
If you want to delete one of your recorded measurements, follow these steps:

1. Make sure the monitor is inactive; press the START/STOP button to put it off if needed.
2. Press MEM to go to Memory. One of the user symbols will start blinking.
3. To switch to the other user, press the SET button.
4. Use the MEM and SET buttons to find the record you want to delete.
5. Press and hold the START/STOP button for 3 seconds.
6. “DEL” will appear with “Y” blinking. Press the SET button to confirm.
7. If you don’t want to delete it, press the MEM button to get “NO” and SET to confirm.
8. “DONE” will appear, indicating that the selected stored data is deleted.

In case you want to delete ALL of your recorded measurements for one user, follow these steps:

1. When the device is in the memory function, select the user whose records you want to delete and press the SET button for 3 seconds.
2. “DEL” will appear on the screen and “AL” will be blinking
3. Press the SET button to confirm.
4. “DONE” will show meaning all the selected stored data for that user is deleted.

Components of the BPM
WARNING: No modification of this equipment is allowed.

Caution
This device is intended for indoor, home use.

• This device is not intended for public use.

• This device is portable, but it is not intended for use during patient trans-port.

• This device is not suitable for continuous monitoring during medical emer-gencies or operations.

• This device is intended for non-invasive measuring and monitoring of arte-rial blood pressure. It is not intended for use on extremities other than the arm, or for any purpose other than obtaining a blood ressure measurement.

• This device is for adults. Do not use this device on babies or infants. Do not use it on children unless otherwise instructed by a medical professional.

• Do not use on pregnant women, including pre-eclamptic, patients.

• The device is not suitable for use on patients with implanted, electrical devices, such as cardiac pacemakers, defibrillators.

• The effectiveness of this device has not been established for use:

  • on users with common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation,
  • on users with peripheral arterial disease,
  • on users undergoing intravascular therapy, or with arteriovenous (AV) shunt. Consult a medical professional before use.

• Do not use this device for diagnosis or treatment of any health problem or disease. Contact your physician if you have or suspect any medical problem. Do not change your medications without the advice of your physician or health care professional.

• If you are taking medication, consult your physician to determine the proper time to measure your blood pressure.

• This device may be used only for the intended use described in this manual, the manufacturer shall have no liability for any incidental, consequential, or special damages caused by misuse or abuse.

• Report any unexpected operation or events to the manufacturer.

• Do not apply the cuff on an arm that has an intravenous drip or a blood transfusion attached.

• Do not kink, fold, stretch, compress, or otherwise deform the tube during measuring, as the cuff pressure might continuously increase, which could prevent blood flow and result injury.

• Taking blood pressure measurements too frequently could disrupt blood circulation and cause injuries.

• Do not apply cuff to areas on patient where skin is delicate or damaged. Check cuff site frequently for irritation.

• Warning: Do not place the cuff on the arm of a person whose arteries
  or veins are undergoing medical treatment, i.e. intra-vascular access or intra-vascular therapy or an arteriovenous (A-V) shunt, which could disrupt blood circulation and cause injuries.

• Do not place the cuff on the arm on the same side of a mastectomy (es-pecially when lymph nodes have been removed). it is recommended to take measurements on the unaffected side.

• Do not wrap the cuff on the same arm to which another monitoring device is applied. One or both devices could temporarily stop functioning if you try to use them at the same time.

• Please check that the operation of the device does result in prolonged impairment of patient blood circulation.

• Warning: On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, loosen and remove the cuff immediately. Prolonged high pressure applied to the arm (cuff pressure

• 300 mmHg or constant pressure >15 mmHg for more than 3 minutes) might lead to bruising and discolored skin.

• Warning: Do not use this device with high-frequency (HF) surgical equip-ment at the same time.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 the wrist and fingers, causing pain and ecchymosis.

• Use the device according to the instructions of this manual to guarantee 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, but those allergic to polyester, nylon, or plastic may take caution.

• There is no need for calibration during the two years of guaranteed service.

Maintenance

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 better performance, keep it in a room with a stable temperature and away from dust.The cuff should not be cleaned as it may affect the accuracy of the reading.

EMC guidance
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environ-ments.
Warning: Don’t be near the active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.

Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Warning: Use of accessories, trans-ducers, and cables other than those specified or provided by the manufac-turer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment TMB-2088-C including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Technical description

1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excep-ted service life.
2. Guidance and manufacturer’s declaration – electro-magnetic emissions and Immunity

Safety information
The signs below might be in the user manual, labeling, or other components. They are the requirement of standard and using.

Guidance and manufacturer’s declaration – electromagnetic emissions

Emissions test| Compliance
RF emissions CISPR 11|

Group 1

RF emissions CISPR 11

|

Class [ B ]

Harmonic emissions IEC 61000-3-2|

Class A

Voltage fluctuations / flicker emissions

IEC 61000-3-3

|

Comply

Guidance and manufacturer’s declaration – electromagnetic Immunity

Immunity Test| IEC 60601-1-2

Test level

|

Compliance level

Electrostatic discharge (ESD) IEC 61000-4-2

|

±8 kV contact

±2 kV, ±4 kV, ±8 kV, ±15 kV air

|

±8 kV contact

±2 kV, ±4 kV, ±8 kV, ±15 kV air

Electrical fast transient/burst IEC 61000-4-4| ±2 kV for power supply lines

±1 kV signal  input/output 100 kHz repetition frequency

| ±2 kV for power supply lines Not Applicable

100 kHz repetition frequency

Surge IEC61000-4-5| ±0.5 kV, ±1 kV differential mode

±0.5 kV, ±1 kV, ±2 kV common mode

| ±0.5 kV, ±1 kV differential mode Not Applicable
Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

| 0% UT; 0,5 cycle. At 0°, 45°, 90°, 135°,

180°, 225°, 270° and 315°.

0% UT; 1 cycle and 70% UT;  25/30 cycles; Single phase: at 0°. 0% UT; 250 / 300 cycle

| 0% UT; 0,5 cycle. At 0°, 45°, 90°, 135°,

180°, 225°, 270° and 315°.

0% UT; 1 cycle and 70% UT;  25/30 cycles; Single phase: at 0°. 0% UT; 250 / 300 cycle

Power frequency magnetic field IEC 61000-4-8| 30 A/m

50 Hz / 60 Hz

| 30 A/m

50 Hz / 60 Hz

Conduced RF IEC61000-4-6

| 3 V

0,15 MHz – 80 MHz

6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz

80% AM at 1 kHz

| 3 V

0,15 MHz – 80 MHz

6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz

80% AM at 1 kHz

Radiated RF IEC61000-4-3

| 10 V/m

80 MHz – 2,7 GHz

80% AM at 1 kHz

| 10 V/m

80 MHz – 2,7 GHz

80% AM at 1 kHz

NOTE UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration – electromagnetic emissions
NOTE UT is the a.c. mains voltage prior to application of the test level.

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.
NOTE: If the product still does not work, contact our Customer Service. Under no circumstance should you disassemble or attempt to repair the unit by yourself.

No power

|

Display can not light up.

| Batteries are depleted.| Replace with new batteries.
Batteries are inserted incorrectly.| Insert the batteries correctly.
Adapter is inserted incorrectly.| Insert the AC adapter correctly.
High Battery| bAt H shows| The battery is too high.| Replace with new batteries.
Low Battery| bAt Lo shows| The battery is too low.| Replace with new batteries.

Error message

|

E 1 shows

| The cuff is not wrapped or wrapped incorrectly, or the cuff air plug is loose.| Refasten the cuff and insert air tube plug correctly then measure again.
E 2 shows| Excessive body motion (such as shaking of the arm with the cuff on)

or weak Pulse is detected.

| Relax for 5 minutes. and then keep still, measure again.
E 3 shows| Pulse is not detected during measuring.| Loosen the clothing on the arm and measure again.
E 4 shows| The measurement failed.| Relax for 5 minutes and measure again.
EEx shows| Hardware error

(X can be some digital symbol, such as 1, 2, 3, etc.)

| Turn off monitor and measure again. If EEx still appears on the display, please contact the retailer or our customer service.
Err & Usb shows| Adapter error| Replace with the authorized adapter.
Warning message| Out shows| Out of measurement range| Relax for a moment and then measure again. If the problem persists, contact your physician.

Copyright
iProven 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 the prior written consent of iProven. 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. iProven reserves the right of final interpreta-tion of this document.

Warranty
This Limited Warranty covers any defects in materials or work-manship under normal use during the Warranty Period. iProven will either replace the product or repair the product at no charge, using new or refurbished replacement parts. The Warranty Period of this iProven product is 5 years from the date of purchase. A replace-ment 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. If for any reason you are unsatisfied with our product, feel free to reach out to iProven directly. We offer a refund or will replace the product for free within 100 days from your purchase.
Contact us: [email protected]

DISTRIBUTED BY
NETDIRECT DISTRIBUTION, LLC 9360 Federal Blvd Federal Heights, CO 80260, USA
Phone: 1-503-974-0913

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