InBody BPBIO750 Blood Pressure Monitor User Manual

August 10, 2024
InBody

InBody BPBIO750 Blood Pressure Monitor

Product Information

Specifications

  • Model: BPBIO750
  • Manufacturer: InBody Co., Ltd.
  • Intended Use: Not designed for a home environment

Product Usage Instructions

BPBIO750 Installation

  1. Product Components
    Refer to the user manual for a detailed list of components.

  2. Operating Environment
    Ensure the device is operated in a suitable environment as per the manufacturer’s guidelines.

  3. Installation Instructions
    Follow the step-by-step installation guide provided in the user manual.

  4. Loading and Reloading Printer Paper
    Refer to the user manual for instructions on how to load and reload printer paper.

  5. Replacing Cuff Cover
    Instructions on replacing the cuff cover are outlined in the user manual.

  6. Setup
    Follow the setup instructions provided in the user manual to configure the device.

  7. Precautions for Maintenance
    Adhere to the maintenance precautions mentioned in the user manual to ensure the proper functioning of the device.

Blood Pressure Test

  1. Preparatory Steps
    Prepare for the blood pressure test as per the instructions provided.

  2. Test Instructions
    Follow the step-by-step test instructions outlined in the user manual.

  3. Test Posture
    Adopt the correct posture during the blood pressure test as directed in the user manual.

Transportation and Storage

  1. Transportation Precautions
    Take necessary precautions while transporting the device to prevent damage.

  2. Repacking Instructions
    Refer to the repacking instructions for proper packaging of the device during transportation.

  3. Transportation and Storage Environment
    Maintain the recommended environment conditions during transportation and storage of the device.

FAQ

  1. Error Code
    Find solutions to common error codes in the user manual’s FAQ section.

  2. Regarding the Equipment
    Answers to frequently asked questions about the device are provided in this section.

  3. Regarding the Test
    Clarifications on test-related queries can be found in this part of the FAQ.

Intended Use
The BPBIO750 is a digital monitor intended for use in measuring blood pressure and pulse rate in the user population with left and right upper arm circumference ranging from 17cm to 42cm (7-inch to 17-inch). The systolic blood pressure and diastolic blood pressure are measured by the non-invasive blood pressure (“NIBP”) measuring method. The BPBIO750 may provide useful clinical information about the current health status of not only the users who are diagnosed with hypertension but also those who are not diagnosed with hypertension. Warnings and cautions described in the user’s manual should be observed at all times.

This device is not designed for use in a home environment.

Headquarters Information

InBody Co., Ltd. [HQ]

  • 625, InBody Bldg., Eonju-ro, Gangnam-gu, Seoul 06106 Republic of Korea
  • TEL: +82-2-501-3939 FAX: +82-2-578-5669
  • Website: inbody.com
  • E-mail: info@inbody.com

InBody Co., Ltd. [MANUFACTURER]

  • 15, Heugam-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do 31025 KOREA
  • TEL: +82-41-581-3003
  • FAX: +82-41-581-3103
  • Website: inbody.com
  • E-mail: info@inbody.com
  • 330 Yeongok-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do 31026 KOREA
  • TEL: +82-41-417-0515
  • FAX: +82-41-417-0516

Representative & Sponsor Information

InBody Europe B.V.

Australian Sponsor. [AUSTRALIA]
Emergo AUSTRALIA. Level 20, Tower II, Darling Park, 201 Sussex Street, Sydney, NSW 2000, AUSTRALIA.

Customer Service Information

InBody USA [USA]

InBody Japan [JAPAN]

InBody China [CHINA]

InBody Asia [ASIA]

  • Unit 3A-11, Oval Damansara, 685 Jalan Damansara Kuala Lumpur, WP KL 60000 Malaysia
  • TEL : +60-3-7732-0790
  • FAX: +60-3-7733-0790
  • Website: inbodyasia.com
  • E-mail: info@inbodyasia.com

InBody India [INDIA]

  • 57/57 A,1st Floor, Raj Industrial Complex, Military Road, Marol, Andheri (East). Mumbai- 400059, Maharashtra, India
  • TEL : +91-22-6223-1911
  • Website: inbody.in
  • E-mail: india@inbody.com

Copyright

  • Reproduction, adaptation, or translation of this manual is prohibited without prior written consent from InBody Co., Ltd. under the copyright laws. This manual may be printed incorrectly and subject to change without notice. InBody Co., Ltd. shall not be liable for any errors, incidental, or consequential damages that occurred by not complying with the content of the User’s Manual. Visit our website (inbody.com) to view and download additional information about the InBody.
  • InBody Co., Ltd. reserves the right to modify the appearance, specifications, etc. of this product to improve its quality, without prior notice.

©2023 InBody Co., Ltd. All rights reserved.

Safety Symbols Used in the User’s Manual

  • Warning
    Failure to comply with safety warnings and regulations can cause serious injury or death.

  • Caution
    Failure to comply with safety precautions can damage the equipment.

  • Note
    Reading the notes can help you get the most out of your device.

BPBIO750 Installation

Product Components
  • The BPBIO750 consists of the following components. Make sure all of the components are present.
  • Please check each component for damage prior to installation.

Standard Components

Optional Components

Operating Environment

Please make sure the environment is appropriate for the BPBIO750 installation. This equipment is designed for indoor use. If installing the equipment outdoors, the following requirements must be fulfilled.

  • Temperature range 5 – 40 ℃
  • Relative humidity 15 to 90% RH
  • Atmospheric pressure 70 to 106 kPa

Installation Instructions

  1. Open the BPBIO750 box and remove the packing pads. Remove the protective vinyl on the BPBIO750 and take it out of the box. Remove the packing material.
    Caution

    • Do not carry the equipment by the cuff.
    • Keep packing material to store the BPBIO750. Dispose of trash according to local laws and regulations.
    • Refer to the figure below when transporting the BPBIO750.
  2. Place the equipment on a solid table that can withstand the weight of the BPBIO750 (approx. 7.1kg). If using the optional BPBIO750 desk, align the desk fixing grooves on the bottom of the BPBIO750 with the grooves on the desk and secure them with the two fixing screws.
    Caution
    Install the BPBIO750 on a flat, vibration-free surface. If the device is installed on a surface that is not flat, it may topple during testing or the results may be inaccurate.

  3. Connect the provided power cable.

    • Plug the power cable into a grounded 3-prong outlet.
      Warning

    • Do not install the equipment where the power cable is difficult to disconnect.

    • Always use an outlet designed for the correct power supply (AC100-240 V). An incorrect power supply may cause fire or equipment malfunction.

    • If using multiple tabs, ensure it has a sufficient power capacity or use an extension cable.

    • Do not disassemble the equipment arbitrarily. This may cause electric shock or injury, product malfunction, and/or inaccurate results. Unauthorized disassembly will void the manufacturer’s warranty.

    • Do not let the BPBIO750 touch other electronic devices when turned on. This may cause electric shock.

    • Caution
      Plugging the device into an ungrounded outlet may cause malfunction or electric shock and/or inaccurate results.

  4. Use the anti-theft groove to prevent theft.

  5. Theft protection cable is sold separately.

  6. Turn the BPBIO750 on by pressing the power switch located on the back of the device

  7. When powered on, the BPBIO750 will automatically calibrate and display the following screen.
    Caution
    Do not operate or touch the device while it is calibrating. It may cause errors in future tests.

  8. Adjust the volume by turning the volume knob on the rear of the BPBIO750.

Loading and Reloading

Printer Paper

  1. Press the button shown below to open the cover while the BPBIO750 is turned off.
  2. Insert the printer paper in the direction as shown below. After inserting the printer paper, let a certain amount of paper come out of the cover, then close it to complete the installation.

Caution

  • The printer will not work if the paper is inserted in the wrong direction.
  • Remove all trash from previous printer paper rolls when replacing them with the new printer paper.

Note

  • Two rolls of printer paper are provided with the BPBIO750.
  • If an additional printer paper roll is needed, it may be purchased separately.

Replacing Cuff Cover
The cuff cover of the BPBIO750 should be replaced periodically for sanitary purposes. Follow the guide below to replace the cuff cover.

  1. Remove the front cover of the BPBIO750 by pushing downward, and loosen the screw with a screwdriver. Remove the ring on the front of the BPBIO750 by pulling it forward.

  2. Push in the seam of the cuff cover as shown below to separate the cuff cover.

  3. Pull the cuff cover as shown below to remove it from the device.

  4. Place the seam of the new cuff cover down as shown below, and align it with the front and rear rings.

    • Caution
      The blood pressure reading may be inaccurate if the seam does not face down.
  5. Reattach the front and rear rings to the BPBIO750 and secure them with the screws. Close the front cover of the BPBIO750.

Note

  • Two cuff covers are included with the BPBIO750. (One is already installed in the equipment.)
  • You may purchase additional cuff covers separately.
Setup

The setup consists of time settings, sound settings, Result Sheet printing, pressure unit settings, and communication settings.

  1. Configuring Setup

  2. When the ‘ ’ and ‘Print’ buttons are pressed and held simultaneously for 2 seconds while on the home screen, ‘F01 ’(Time setting) will blink. The current setting status will be shown in the Diastolic (H0U) column and Pulse (Hour value) column.

  3. When the Systolic column is blinking, you can go to the desired setting item. Press the UP / DOWN buttons to move to the other setting items. UP/DOWN buttons are located beneath the printer cover of the device.

  4. To adjust the setting value, press the button. The set value can be changed with the UP / DOWN buttons, and the set value of the corresponding item is displayed in the Pulse column.

  5. Press the button to save the setting value. Then, you can go back to the desired setting item.

  6. Once you are finished adjusting all settings, press and hold the Print button for 2 seconds to return to the home screen.

  7. Setup Example
    The following is an example showing how to change the automatic Result Sheet printing option to a manual printing option.

  8. While on the home screen, press and hold the buttons simultaneously time for more than 2 seconds. The current setting is shown on the‘F01 ’ screen, the first screen of Setup.

  9. Press the ‘UP/DOWN’ buttons to go to the ‘F07 Prt ’ screen. In the Pulse column, the current setting value is displayed as ‘ON ’.

  10. Press the button to enter the corresponding item, and then use the UP / DOWN buttons to change the current setting value from ‘ON ’ to ‘OFF ’.

  11. Press the button to save the setting value, and the display will return to the Setup screen.

  12. Check the setting value of the Pulse column to confirm your desired setting, then press and hold the button for 2 seconds to return to the home screen.

  13. Detailed description of Setup
    When configuring Setup, the following messages will be displayed in the Systolic, Diastolic, and Pulse screen.

“QR Code” is a registered trademark of DENSO WAVE INCORPORATED.

Precautions for Maintenance

Caution

  • Never move the equipment while the power is on.
  • Do not let foreign objects like dust and liquid enter the device, as they can cause damage to electrical components.
  • Clean the exterior of the equipment gently with a lint-free cloth once a week. Do not scratch the LED screen while cleaning the equipment.
  • Replace the cuff cover when it becomes dirty or worn out.
  • Packing material and other waste should be disposed of according to the relevant laws and regulations.
  • It may be necessary for a specialist to inspect the device once every two years to maintain its performance and safety.
  • In the event of an incident related to cybersecurity, side effects, or accident, contact InBody Customer Service. It should be reported to the manufacturer and competent authority.

Check the environment before installing the device.

  • Make sure the equipment is not damaged from impact.
  • Make sure the equipment is not contaminated.
  • Make sure the equipment is not wet.
  • Make sure the power cord is completely plugged in.
  • Make sure the power cord is not damaged.
  • Make sure the power cord is not a tripping hazard.

The BPBIO750 calibrates automatically when it is turned on, If an error message appears during calibration, please contact product support.

Blood Pressure Test

Preparatory Steps

Caution

  • The examinee should rest at least 5 to 10 minutes before the test.
  • Do not roll up the examinee’s sleeve; instead, remove thick clothing
  • The examinee should sit up straight in the chair.
  • Insert the examinee’s arm until the elbow is positioned in the elbow groove.
  • Adjust the height of the chair so that the inserted upper arm and heart are horizontal.
  • Test in a relaxed state.
  • The examinee should not talk or move during the test.

Test Instructions

  1. Adjust the height of the chair so that the inserted upper arm and heart are horizontal.

  2. Rest for at least 5 minutes before taking the test. If the examinee tests in an agitated state, the results may be inaccurate and read higher than normal.

  3. Insert the arm until the elbow is positioned in the elbow groove, as shown below. When the elbow is placed in the right position, the blue LED light will light up on the display.

  4. Press the Start/Stop button to start the test.

  5. The cuff automatically pressurizes, and blood pressure is measured.

    • Do not talk or move during the test.

    • Relax while sitting up straight.
      Caution

    • If an emergency occurs during the test, press the or buttons on the bottom (toward the front) of the BPBIO750 – the cuff will quickly release.

  6. The cuff automatically releases once the test has been completed. Wait for the cuff to fully loosen before pulling out your arm.

  7. Check the results on the screen. The voice guidance will activate and the Result Sheet will print according to your settings.

  8. Systolic blood pressure

  9. Diastolic blood pressure

  10. Pulse rate

  11. When the test is not completed due to movement or other factors

  12. When the irregular pulse is detected

  13. Elbow position LED:

  14. Blue: The elbow is placed in the right position

  15. Red: The elbow is not placed in the right position.

    * Users may refer to the ‘Blood Pressure Results’ at the bottom left side of the device to check their blood pressure status.
    * Please consult with your physician for an accurate diagnosis.
  1. Others
    The Start/Stop button on the rear of the BPBIO750 also allows you to initiate the test, which can be useful for the administrator to conduct the test from the back of the device.

Note

  • If the examinee wants to test their blood pressure again, please instruct them to rest for at least 5 minutes.
  • Blood pressure can vary depending on the testing conditions. Please consult your physician for an accurate diagnosis.

Test Posture
For the most accurate results, get into the proper posture for testing.

  • The BPBIO750 allows examinees to measure with either arm.
  • Be sure to place the elbow in the elbow groove before starting the test.
  • Remove thick clothing. Do not roll up your sleeves.
SYS Systolic Blood Pressure [mmHg]
DIA Diastolic Blood Pressure [mmHg]
PUL Pulse rate per minute [bpm]
PP Pulse pressure [mmHg] [SYS – DIA]
MAP Mean Arterial Pressure [mmHg] [1/3 X SYS + 2/3 X DIA]
RPP Rate Pressure Product [PR X SYS]

Transportation and Storage

Cautions during Transportation
To transport the BPBIO750 securely, two people should keep the equipment parallel to the ground.

Caution
When transporting the equipment alone, keep the device horizontal.

Repacking Instructions

  1. Turn off the BPBIO750.
  2. Remove all connected cables and put the packing material into the BPBIO750. Wrap the package in protective vinyl and insert the packing pads into the box.

Caution
When transporting the equipment alone, keep the device horizontal.

Transportation and Storage Environment
The BPBIO750 should be transported or stored under the following conditions.

  • Temperatures range from -20 to 70ºC
  • Relative humidity 10 to 95% RH(No Condensation)
  • Atmospheric pressure ranges from 50 to 106 kPa

FAQs

If a problem persists, please contact Product Support.

Error Code
The error messages will display on the screen if they occur during the test.

Please provide the error code to Product Support.

Regarding the Equipment
If your technical issues cannot be resolved with the information below, please contact Product Support.

Issue:

|

The power does not turn on.

---|---
Potential Solution:| •     Plug the power cable into a properly grounded (3-prong) outlet.

•     When using a power strip, make sure the switch is turned on.

•     Make sure you are using the power cable (AC 250V 10A)provided by InBody.

•     Issue may occur when the fuse is blown. Replace the fuse by following the instructions below:

1   The fuse socket is located on the back of the device beneath the power plug.

2   Pull the fuse out by using a flathead screwdriver. Replace the fuse with the provided spare fuse. Additonal fuses can be purchased if necessary.

Warning

  • Be sure to turn off the power when replacing the fuse.
  • The correct fuse must be used. (250V, 2.5AL)

Issue:

|

Voice guidance does not work.

---|---
Potential Solution:| •     This may occur when the volume knob on the rear of the BPBIO750 is turned off. Adjust the volume knob to your desired level.

•     This may occur when the Sound is set to Beep sound output. ‘F06’. When the Sound is set to ‘4.6EP ’, only the beep sound occurs. If you want the Voice sound output, change the Sound to ‘1.U01 ’.

  • Refer to the ‘Setup’ on page 12.
Issue: The Result Sheet is not printing.
Potential Solution: •     This may occur when the Result Sheet setting has

not been set to print the Result Sheet. When Automatic Printing Option ‘F07’ is set to ‘OFF ‘, the Result Sheet will be printed manually. If you want automatic printing, change the setting to ‘On’.

  • Refer to the ‘Setup’ on page 12.

•     This may occur when the printer is out of paper. Open the printer cover and check if the printer paper needs to be replaced.

•     This may occur when the printer paper is installed incorrectly. Open the printer cover and check the positioning of the printer paper.

•     This may occur when the printer cover is not closed completely. Make sure that the printer cover is closed properly.

  • Refer to ‘Loading and Reloading Printer Paper’.

    • Caution
      The company is not liable for any issues that occur when parties outside of InBody employees repair and inspect the equipment.

    • Note
      Error messages and collateral like Result Sheets containing errors can be used to assist with A/S requests; please record or keep these items.

Regarding the Test
If your technical issues cannot be resolved with the information below, please contact Product Support.

Issue: The test results are incorrect.
Potential Solution: •     The arm and heart may not be aligned during the

test. Adjust the height of the chair to align the arm and heart.

•     InCorrect testing posture. The height of the arm and the heart are aligned.

•     Incorrect testing posture. The arm is higher than the heart. Blood pressure values will be measured later.

•     Inserting the arm too far or not far enough may produce incorrect results. Place elbow in elbow groove for accurate results.

•     Thick clothing or rolled-up sleeves may produce incorrect results.

  • The blood pressure value will be measured higher. Remove thick clothing. Do not roll up your sleeves.

•     The examinee may have tested without resting beforehand. Take the test after resting for at least 5 minutes.

  • The first reading may be high even after taking sufficient rest.

•     Do not talk or move during the test.

Issue:
When should blood pressure be measured? Potential

Solution:
Blood pressure may vary throughout the day, as shown below.

Therefore, the best time to test is when examinees can measure regularly daily. It is recommended to test at the same time each day under the same conditions.

Issue: How frequently can tests be done?
Potential Solution: •     The automatic monitor applies pressure to the arm

to measure blood pressure. Consecutive testing may put a strain on blood vessels. Rest for about 5 minutes between tests.
Issue:| Is there any case that I should not test?
---|---
Potential Solution:| •     If you had blood drawn or had an injection given in either arm, it is recommended to wait at least 1 hour before testing or measuring with another arm.
Issue:| Can results vary depending on the testing environment and temperature?
---|---
Potential Solution:| •     The BPBIO750 can operate at 5 ~ 40ºC. However, if the examinee feels that the temperature is too low or high, the blood vessels expand or contract, which will affect the blood pressure results. It is recommended to test in a stable condition in an environment where the temperature is at a comfortable level.

•     The examinee will not be able to perform a natural and stable test if they are testing in a loud or disruptive environment. It is

recommended to test in an environment free from noise and disturbances.

Issue: What are some factors that can change blood pressure?
Potential Solution: •     The blood pressure reading may change:

–  Within 1 hour after meals

–  After having alcohol or caffeine

–  After smoking

–  After taking a bath

–  After exercise

–  After using the restroom

–  When testing in an unfamiliar location

Issue:| The blood pressure values are different when taken at home compared to the hospital.
---|---
Potential Solution:| •     Blood pressure can change depending on the environment. Test in the same environment for consistent results.

•     Psychologically, people tend to feel more relaxed at home than in the hospital. Blood pressure tends to be higher when measured at the hospital than at home.

Others

  • The BPBIO750 was manufactured according to the quality control procedure of InBody Co., Ltd. InBody complies with ISO9001 and ISO13485, which are international quality management systems.
  • This equipment satisfies the common standard for electrical and mechanical safety of medical devices and the common standard for the safety of medical devices.

Exterior and Functions

Below is a list of BPBIO750 components and their functions.

Please check each component of the system for damage before installation.

  1. A display screen showing results, time, and test instructions
  2. A blood pressure guideline.
  3. A button to print Result Sheets
  4. A button to start or stop a test
  5. Emergency stop button
  6. Printer paper cover
  7. UP buttons to adjust settings
  8. DOWN buttons to adjust settings
  9. A switch to turn the equipment on/off
  10. Input for external power source (200-240V. 50/60Hz), Fuse (F2.5AL, 250V).
  11. A terminal to communicate with the multi-display device
  12. RS232C (9-pin serial) connection terminal
  13. USB Port
  14. A port to connect a mercury monitor to adjust the pressure value
  15. Volume control knob
  16. Rear Start/Stop button

Safety Information

Warning

  • If this equipment has been altered, it must be inspected to ensure that it can be used safely.
  • Results can only be interpreted by experienced healthcare professionals. It cannot be used for diagnosis, medication, or other treatments performed at the consumer’s discretion without a doctor’s prescription.

Caution

  • Excessively high or low temperatures, humidity, and pressure may affect the operation of the equipment and cause malfunction. Use the blood pressure monitor within the range specified in the product specifications.
  • Do not touch the external device connections such as the RS232C (9-pin serial) connection terminal on the back of the equipment.
  • Packing material and other waste should be disposed of according to the relevant laws and regulations.
  • Do not connect the unauthorized devices.

Safety Symbols

Etc. Symbols

Product Classification
Oscillometric multi-functional electronic blood pressure monitor

  • Type of protection against electric shock: Class 1 device
  • Level of protection against electric shock: BF-type
  • Class of protection against electromagnetic radiation intensity: Class A
  • Level of protection against flooding: General Equipment (No special protection against external water infiltration)

Specifications

Test Instructions|

Oscillometric

---|---

Test range

| Pressure: 0 to 300 mmHg

Pulse: 30 to 240 bpm

Degree of precision| Pressure: ± 2mmHg Pulse: Within ± 1.5%

Test result

| Systolic blood pressure, diastolic blood pressure, pulse rate, pulse pressure, mean arterial pressure, rate pressure product

Test Time

| Approx. 30 seconds on average

(20-50 seconds depending on the pulse and blood pressure value)

Pressurization

Time

|

Approx. 10 seconds

Minimum scale unit|

1mmHg

Screen Type| 7-Segment LED

Results Sheet outputs

| Systolic and Diastolic blood pressure, Mean arterial pressure, Pulse pressure, pulse, Rate pressure product, Pulse envelope, Blood pressure graph, Check posture, and Blood pressure knowledge
Storage function| Can store the total results for up to 1 million tests
Energy saving| Automatically enters the energy saving mode after 2 minutes of the idle time

Dual safety mechanism

| The air will be released when the Start/Stop button is pressed.

The air will be released automatically when the air pressure exceeds 300 mmHg.

The air will be released when the Emergency Stop button is pressed.

(The dual safety mechanism enables the cuff to release the air regardless of the central controller when the Emergency Stop button is pressed.)

Voice guidance

|

Guides user through blood pressure measurement and results

Printer

| High-speed thermal printer with a built-in automatic cutter (width: 5.7 cm)
Rated voltage and Power

consumption

|

AC 100-120 / 200-240V, 50/60Hz, 48VA

---|---
Dimensions| Approx. 299 (W) × 547 (D) × 485 (H) mm
Weight| Approx. 7.1 kg

Operating environment

| Temperature 5 ~ 40ºC , Humidity 15 ~ 90% RH,

Atmospheric pressure 70 ~ 106 kPa

Storage environment

| Temperature -20 ~ 70ºC , Humidity 10 ~ 95% RH,

Atmospheric pressure 50 ~ 106 kPa (No Condensation)

  • Specifications are subject to change without notice for purposes of product improvement.
  • This product is a ‘medical equipment’. Please read the guide and caution before using this blood pressure monitor.

EMC Declaration

Phenomenon| Basic EMC

standard or test method

| Operating mode| Port tested| Test Voltage| Test level/requirement
---|---|---|---|---|---

Mains terminal disturbance voltage

| CISPR 11:2015

+A1:2016+A2:2019 EN 55011:2016

+A1:2017

|

Continuous operation mode

|

AC Mains

| 100 V, 50 Hz

100 V, 60 Hz

120 V, 60 Hz

220 V, 60 Hz

230 V, 50 Hz

|

Group 1, Class B

Radiated disturbance

| CISPR 11:2015

+A1:2016+A2:2019 EN 55011:2016

+A1:2017

|

Continuous operation mode

|

Enclosure

| 100 V, 50 Hz

100 V, 60 Hz

120 V, 60 Hz

220 V, 60 Hz

230 V, 50 Hz

|

Group 1, Class B

Harmonic Current Emission

| IEC 61000-3-2:2018

+A1:2020

EN 61000-3-2:2014

| Continuous operation mode|

AC Mains

|

230 V, 50 Hz

|

Class A

Voltage change,

Voltage fluctuations and Flicker Emission

| IEC 61000-3-3:2013

+A1:2017

EN 61000-3-3:2013

+A1:2019

|

Continuous operation mode

|

AC Mains

|

230 V, 50 Hz

| Pst: 1

Plt: 0.65

dmax: 4%

dc: 3.3%

Electrostatic Discharge Immunity

|

IEC 61000-4-2:2008

EN 61000-4-2:2009

|

Continuous operation mode

|

Enclosure

| 100 V, 50 Hz

100 V, 60 Hz

120 V, 60 Hz

220 V, 60 Hz

230 V, 50 Hz

| ± 8 kV/Contact

± 2, ± 4, ± 8,

± 15 kV/Air

Radiated RF Electromagnetic Field Immunity

|

IEC 61000-4-3:2020

EN 61000-4-3:2006

+A2:2010

|

Continuous operation mode

|

Enclosure

| 100 V, 50 Hz

100 V, 60 Hz

120 V, 60 Hz

220 V, 60 Hz

230 V, 50 Hz

|

3 V/m

80 MHz-2.7 GHz

80% AM at 1 kHz

Immunity to Proximity Fields from RF wireless

Communications Equipment

|

IEC 61000-4-3:2020

EN 61000-4-3:2006

+A2:2010

|

Continuous operation mode

|

Enclosure

| 100 V, 50 Hz

100 V, 60 Hz

120 V, 60 Hz

220 V, 60 Hz

230 V, 50 Hz

|

Table 9 in

IEC 60601-1-2:

2014

Electrical Fast Transient/ Burst Immunity

|

IEC 61000-4-4:2012

EN 61000-4-4:2012

|

Continuous operation mode

| AC Mains| 100 V, 50 Hz

100 V, 60 Hz

120 V, 60 Hz

220 V, 60 Hz

230 V, 50 Hz

| ± 2 kV, 100 kHz repetition frequency
SIP/SOP| ± 1 kV, 100 kHz

repetition frequency

Surge Immunity

|

IEC 61000-4-5:2014

EN 61000-4-5:2014

+A1:2017

|

Continuous operation mode

|

AC Mains

| 100 V, 50 Hz

100 V, 60 Hz

120 V, 60 Hz

220 V, 60 Hz

230 V, 50 Hz

| Line to Line

± 0.5 kV, ± 1 kV

Line to Ground

± 0.5 kV, ± 1 kV, ± 2 kV

Immunity to

Conducted Disturbances Induced by

RF fields

|

IEC 61000-4-6:2013

EN 61000-4-6:2014

|

Continuous operation mode

|

AC Mains

|

100 V, 50 Hz

100 V, 60 Hz

120 V, 60 Hz

220 V, 60 Hz

230 V, 50 Hz

| 3 V

0.15-80 MHz

6 V in ISM bands

Between 0.15 MHz and 80 MHz

80% AM at 1 kHz

SIP/SOP

Power Frequency Magnetic Field

Immunity

|

IEC 61000-4-8:2009

EN 61000-4-8:2010

|

Continuous operation mode

|

Enclosure

| 100 V, 50 Hz

100 V, 60 Hz

120 V, 60 Hz

220 V, 60 Hz

230 V, 50 Hz

|

30 A/m

50 Hz & 60 Hz

Voltage dips

|

IEC 61000-4-11: 2020

EN 61000-4-11:2004

+A1:2017

|

Continuous operation mode

|

AC Mains

| 100 V, 50 Hz

100 V, 60 Hz

240 V, 50 Hz

240 V, 60 Hz

220 V, 60 Hz

| 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 0º

Voltage interruptions

|

IEC 61000-4-11: 2020

EN 61000-4-11:2004

+A1:2017

|

Continuous operation mode

|

AC Mains

| 100 V, 50 Hz

100 V, 60 Hz

240 V, 50 Hz

240 V, 60 Hz

220 V, 60 Hz

|

0 % UT; 250/300 cycle

Electromagnetic immunity
The BPBIO750 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Portable RF communications equipment should be used no closer than 30 cm (12 inches) to any part of the BPBIO750. Otherwise, degradation of the performance of this equipment could result.

Immunity test| Band a)| Service a)| Modulation b)| IEC60601 test level| Compliance level
---|---|---|---|---|---

Proximity fields from RF wireless Communications IEC61000-4-3

| 380 – 390 MHz| TETRA 400| Pulse modulation b) 18Hz| 27 V/m| 27 V/m

430 – 470 MHz

|

GMRS 460

FRS 460

| FM c)

±5 kHz deviation 1 kHz sine

|

28 V/m

|

28V/m

704 – 787 MHz

|

LTE Band13, 17

|

Pulse modulation b) 217 Hz

|

9 V/m

|

9 V/m

800 – 960 MHz

| GSM800:900 TETRA 800

iDEN 820

CDMA 850

LTE Band 5

|

Pulse modulation b) 18 Hz

|

28 V/m

|

28 V/m

1700 – 1990 MHz

| GSM 1800

CDMA 1900

GSM 1900 DECT

LTE Band 1,2,4,25 UMTS

|

Pulse modulation b) 217 Hz

|

28 V/m

|

28 V/m

2400 – 2570 MHz

| Bluetooth WLAN

802.11b/g/n RFID 2450

LTE Band 7

|

Pulse modulation b) 217 Hz

|

28V/m

|

28 V/m

5100 – 5800 MHz

|

WLAN 802.11a/n

| Pulse modulation b) 217 Hz|

9 V/m

|

9 V/m

NOTE:
If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1m. The 1m test distance is permitted by IEC 61000-4-3.

  • For some services, only the uplink frequencies are included.
  • The carrier shall be modulated using a 50% duty cycle square wave signal.
  • As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be the worst case.

©2023 InBody Co., Ltd. All rights reserved. IM-H2-ENG-A-231227.

References

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