WITHINGS WPM04 BPM Core Smart Blood Pressure Monitor User Guide

WITHINGS WPM04 BPM Core Smart Blood Pressure Monitor

Product Information

The Withings BPM Core is a smart blood pressure monitor that comes with an ECG and digital stethoscope. The device is intended for use by adults only and is not recommended for use on children or pets. It is designed to measure blood pressure, record an ECG, and record heart sounds. The device comes with an arm cuff and electrodes that are in contact with the skin. The USB charging cable is provided with the device for charging purposes only. The device should not be disassembled, and the cuff should not be forcibly bent or inflated when not wrapped around the arm. The device should not be used after bathing, drinking alcohol, smoking, exercising, or eating. It should not be used with a pacemaker, a defibrillator, or other electric implants. The device should not be operated in a moving vehicle (car, airplane), and the cuff should not be applied over a wound or injury. It is important to consult a doctor before using the device if you suffer from arrhythmia and arteriosclerosis or during pregnancy. Self-diagnosis of measurement results and self-treatment are dangerous. Any serious incident that has occurred in relation to the Withings BPM Core should be reported to Withings and competent authorities in your country of residence.

Product Usage Instructions

1. Review the information in the product guide before using the Withings BPM Core.
2. Charge the device using the provided USB charging cable.
3. Wrap the arm cuff around your arm and ensure it is not forcibly bent or inflated when not in use.
4. Do not take a measurement after bathing, drinking alcohol, smoking, exercising, or eating.
5. Ensure that the cuff is not applied over a wound or injury.
6. Press the button on the device to start the measurement process.
7. Wait for the device to complete the measurement and display the results.
8. Record the blood pressure, ECG, and heart sounds as required.
9. Consult a doctor before using the device if you suffer from arrhythmia and arteriosclerosis or during pregnancy.
10. Do not disassemble the device or leave it unattended with infants.
11. Report any unexpected operations or events to Withings and competent authorities in your country of residence.

Box Content

Important notice

Before using Withings BPM Core, review the information in this guide:
Please contact Withings when in need of assistance, setting up, using, or maintaining the device, or to report unexpected operations or events. The user is an intended operator. Any serious incident that has occurred in relation to the Withings BPM Core should be reported to Withings and competent authorities in your country of reside

Intended use
Withings BPM Core is a digital monitor intended for use in measuring blood pressure and heart rate, recording a one-lead ECG to detect atrial fibrillation, and uncovering valvular heart diseases (aortic stenosis, aortic regurgitation, mitral regurgitation). The device is intended to be used in a human adult population with an arm circumference of 9 inches to 17 inches (22 cm to 42 cm). Withings BPM Core is a medical device. Contact your physician if hypertensive values, atrial fibrillation (AFib), or VHD are indicated. nice. In order to use your Withings BPM Core, you need an iOS (14.0 or higher) or Android (8.0 and higher) device to install it. Thereafter, the product can be used without your mobile device on you, thanks to the Wi-Fi and Bluetooth® connections.

Warnings and safety notices

• Do not forcibly bend the arm cuff.
• Do not inflate the arm cuff when it is not wrapped around your arm.
• Do not apply strong shocks and vibrations to the blood pressure monitor or drop it.
• Do not take a measurement after bathing, drinking alcohol, smoking, exercising or eating.
• Do not immerse the arm cuff in water.
• Do not use a pacemaker, a defibrillator, or other electric implant.
• Use on adults only.
• Do not use it on children or pets.

Consult your doctor during pregnancy, or if you suffer from arrhythmia and arteriosclerosis. Please read this section carefully before using this smart blood pressure monitor with ECG & digital stethoscope. Always consult your doctor. Self-diagnosis of measurement results and self-treatment are dangerous. People with severe blood flow problems or blood disorders should consult a doctor before using the blood pressure monitor. Cuff inflation can cause internal bleeding. Operational factors such as common arrhythmias, ventricular premature beats, arteriosclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia, or renal disease can affect the performance of the automated sphygmomanometer and/or its blood pressure reading. This is a precision measuring device that may be understood by lay users, but should still be handled with care. Exposing the device to prolonged lint, dust, or sunlight might reduce its life or damage it. A damaged cuff or sensor may lead to incorrect measurements. The USB port should only be used for charging the device. Parts in contact with the skin: cuff and electrodes. Measurements can be affected by extreme temperatures, humidity & altitude.

• Do not leave the blood pressure monitor unattended with infants. Strangulation may occur.
• Do not use the blood pressure monitor for any purpose other than measuring blood pressure, recording an ECG, and recording heart sounds.
• Do not disassemble the blood pressure monitor.
• Do not operate the blood pressure monitor in a moving vehicle (car, airplane).
• Do not use the device with the USB cable plugged in.
• Do not shake the unit violently.
• Improper continuous pressure of the cuff or too-frequent measurements may interfere with blood flow and result in injury to the user. Check to ensure that the use of the device does not result in prolonged impairment of your blood circulation.
• Do not apply the cuff over the user’s arm if it has a wound or medical treatment, as this can cause further injury.
• Consult your physician before using this monitor if you have had a mastectomy.

Warnings and safety notices

• The use of the device can temporarily cause the loss of function of equipment that is used simultaneously on the same limb.
• Do not use if you have a congenital cardiomyopathy, aortic-venous fistula, pulmonary pathology, a prosthetic heart valve, if you are on kidney dialysis, or if you are hemodynamically unstable.
• There is a risk concerning Lead, PZT, DEHP, DBP, SCCP, and D6 according to REACH regulation 1907/2006.

Types of measurements
Withings BPM Core allows you to take two types of measurements:

• Blood pressure and heart rate, which uses the cuff as a sensor.
• ECG and Heart Sound recording, which uses three electrodes (two inside the cuff, the other on the metal tube) and the stethoscope (the circular white sensor on the cuff).

Before the measurement
Before the measurement, make sure that you:

• Choose a calm, quiet room to take the measurement.
• Ensure you have a chair, one with a back, and a table or armrest on which you can place your arm.
• Use the device on the left upper arm.
• Do not speak or move during the measurement.
• Wear only one layer of clothing, which should not cover your left arm. The electrodes should be in contact with the skin.

How to take measurements

1. Sit down in a comfortable position, legs uncrossed, feet flat on the floor, and arm and back support. Uncover your left arm. Rest for 5 minutes before the first measurement.

2. Tighten the cuff around your arm. The stethoscope should be facing the rib cage, with the metal tube facing down about one inch above the elbow.

3. For blood pressure measurement. Place your left arm on a table with the cuff level with your heart and your palm facing up. Make sure the cuff is not touching the left side of your chest. Your arm should be resting comfortably on the table without making any effort. Do not speak or move during the measurement.

4. For ECG and Heart Sounds recording:
   The excess cuff should not overlap the stethoscope. For this measurement, you should place the stethoscope in contact with your chest, and the two electrodes inside the cuff should be in contact with your skin. Make sure that the stethoscope is in contact with your chest during the measurement. Do not speak or move during the measurement. Breathe normally. You do not need to put your left hand on a table.

Standard mode

1. Two measurements in a row will be taken during this mode. The first one is a blood pressure measure-ment, which you should take in the position described on page 5. The second is a combined measurement of an ECG and Heart Sounds recording via the stethoscope. Standard mode

2. Push the button. The screen will display “START.” Push the button once again to start the measurement. The blood pressure measurement starts.

3. When the screen displays the illustrated pictogram, it means that the blood pressure measurements are finished and that you will now proceed to the ECG and stethoscope signal recording. Adjust your arm position to place the stethoscope against your chest, and place your hand on the metal tube to ensure an accurate measurement. You can remove your hand from the table and follow the position described on page 5. Other measurement modes

4. When you push the button to start Withings BPM Core, you can also select “Start x3” or “ECG” by swiping the touch-sensitive area on the screen. “Start x3” launches three blood pressure measurements in a row followed by an ECG and stethoscope measurement. “ECG” will only record the ECG and stethoscope signals. Make sure to use the correct arm position for each measurement type.

5. If an error message appears on the screen, please refer to the explanation displayed in the app and the troubleshooting procedures described beginning on page 9.

LED color signification
The LED display on Withings BPM Core can be:

• Blue: if Withings BPM Core has not been paired with a mobile device yet.
• Green: for optimal and normal blood pressure measurements. The LED can also be green if Withings BPM Core has been paired with a mobile device.
• Orange: for high normal blood pressure measurements. The LED can also be orange if Withings BPM Core has a low battery (you can still take a measurement) or if there is an error during one of the measurements during x3 measurement mode. During x3 mode, you may see a short ERROR display and an orange LED, but afterward, it will give you the option to restart the measurement. If you fail to get a result on the second try, the LED will turn red.
• Red: if hypertension (grade 1, 2, 3) or isolated systolic hypertension is detected. The LED can also be red if Withings BPM Core has no battery or if there is an error during the blood pressure or stethoscope measurement
• Pink: if you press and hold the monitor’s button for 6 seconds until the Settings menu opens and “Training” is displayed on the screen. The LED can also be pink when Withings BPM Core has been factory reset.
• Note: The LED color displayed on the device may vary depending on the classification guidelines of your country. Please go to support.withings.com for more information on blood pressure measurement classification.

VHD detection
Information related to VHD detection is available in the Withings app.
ECG performance
Clinical performance: The ECG algorithm’s ability to accurately classify an ECG into AFib and sinus rhythm was tested in a clinical trial of 115 subjects. Rhythm classification of a 12-lead ECG by a cardiologist was compared to the simultaneous classification of an ECG recorded by Withings BPM Core.

The ECG recording result on the mobile app provides a detailed display of the result.

Withings BPM Core outputs

Troubleshooting

If you cannot fix the problem using the following troubleshooting instructions, please contact Withings or go to: withings.com/support.

Specifications & technical data

• Product Description: Automatic electronic blood pressure monitor with stethoscope, electrocardiogram and heart rate sensor.
• Model: WPM04
• Blood pressure measurement method: Cuff oscillometric method
• Cuff inflation: Automatic inflation with air pump at 5 mmHg/s
• Pressure sensor: Gauge sensor
• Measurement range (pressure): 0 to 285 mmHg, DIA 40 to 130 mmHg, SYS 60 to 230 mmHg
• Measurement range (pulse): 40 to 180 beats/min
• Pressure sensor accuracy: Within +- 3 mmHg or 2% of reading
• Clinical accuracy (blood pressure): Withings BPM Core performance in blood pressure measurement was validated in a clinical trial. The results are within the margin of acceptance defined by the internationally recognized evaluation standard of blood pressure monitors ANSI/AAMI/ISO 81060-2:2013, EN ISO 81060-2:2014 and AAMI/ ESH/ISO 81060-2:2018, developed by the European Society of Hypertension, British Hypertension Society and Association for the Advancement of Medical Instrumentation/American Heart Association. For more information,
• go to: withings.com/support
• Accuracy (pulse): Within +-5% of reading
• Sensor: Semiconductor pressure sensor
• Operating conditions: 5 to 40°C, 15 to 90% RH, atmospheric 86Kpa~106kpa, altitude: 2000m
• Storage and transport conditions: -25 to 70°C, 10 to 95% RH, atmospheric 86Kpa~106kpa, Max altitude: 2000m
• Arm type: Use on the left arm
• Internal Power source: 3.6 VDC Lithium-ion battery
• Weight: Approx. 430g
• Expected minimum product life: 3 years
• Wireless transmission: Wi-Fi and BLE
• Note: Specifications are subject to change without prior notice or any obligation on the parts of the manufacturer.

After use

Cleaning

• Clean the device with a soft and dry cloth.
• Do not use an alcohol-based or solvent agent.
• Do not rinse the device and cuff with a lot of water.
• Do not submerge the device or any of the components in water.

Storage

• Store the device and the components in a clean and safe location.
• If storage conditions are different from the usage conditions indicated in this document, please wait 30 minutes before taking a measurement.

Maintenance

If you cannot fix the problem using the troubleshooting instructions, request service from your dealer. The manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will assist the manufacturer’s staff or authorized representative with the repair. It is generally recommended to have the device inspected every 2 years to ensure proper functioning and accuracy. Do not use the device while doing maintenance steps. Europe – EU Declaration of Conformity
Withings hereby declares that the device Withings BPM Core is in conformity with the essential requirements and other relevant requirements of the applicable EU Directives and Regulations. The full text of the EU Declaration of Conformity can be found at: withings.com/compliance.

Safety and performance

FCC Statement
Federal Communications Commission (FCC) Statement 15.21 You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment. 15.105(b) This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and the receiver.
• Connect the equipment to an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

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 of the device.

FCC RF Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. End users must follow the specific operating instructions for satisfying RF exposure compliance. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.

RF Statement

Declaration – Electromagnetic emissions and immunity

For equipment and systems that are not life-supporting and are specified for use only in a shielded location.

Declaration – Electromagnetic immunity

Disposal
Actuation of European directive 2012/19/EU, for the reduction in the use of dangerous substances in the electric and electronic devices and for garbage disposal. The symbol applied on the device or its packaging means that at the end of its useful life, the product must not be disposed of with domestic waste. At the end of the device’s useful life, the user must deliver it to collection centers for electric and electronic garbage, or give it back to the retailer when purchasing a new device. Disposing of the product separately prevents possible negative consequences for the environment and for health deriving from inadequate disposal. It also allows the recovery of materials of which the device is made up in order to save energy and resources and to avoid negative effects on the environment and health. Failure to comply with the rules for sorting or recycling waste may make the user liable for a fine. The device and its parts are made with regard to disposal, as appropriate, in accordance with national or regional regulations.

Information for users in Canada

This device complies with Part 15 of the FCC Rules and with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation. Changes or modifications made to this equipment not expressly approved by Withings may void the FCC authorization to operate this equipment. Radiofrequency radiation exposure information: The radiated output power of the device is far below the FCC radio frequency exposure limits. Nevertheless, the device shall be used in such a manner that the potential for human contact during normal operation is minimized.

Warranty

Withings Two (2) Years Limited Warranty – Withings BPM Core | Wi-Fi Smart Blood Pressure Monitor | ECG | Digital stethoscope Withings, 2 rue Maurice Hartmann, 92130 Issy-les-Moulineaux, (“Withings”) warrants the Withings- branded hardware product (“Withings Product”) against defects in materials and workmanship when used normally in accordance with Withings’ published guidelines for a period of TWO (2) YEARS from the date of original retail purchase by the end-user purchaser («Warranty Period»). Withings’ published guidelines include but are not limited to information contained in technical specifications, safety instructions or Quick Start Guide. Withings does not warrant that the operation of the Withings Product will be uninterrupted or error-free. Withings is not responsible for damage arising from failure to follow instructions relating to the Withings Product’s use.
Need help?
withings.com/support.

• Ingress of water or particulate matter
• Keep Dry
• Temperature limit
• Atmospheric pressure limitation
• Waste Electrical and Electronic Equipment
• Type BF Applied Part (cuff)
• Direct current
• Read this manual before use
• RCM Regulatory Compliance Mark
• Humidity limitation

UK Responsible Person:

• Emergo Consulting (UK) Ltd c/o Cr360 – UL International
• Compass House, Vision Park Histon
• Cambridge, CB24 9BZ United Kingdom

AUS: Our goods come with guarantees that cannot be excluded under the Australian Consumer Law. You are entitled to a replacement or refund for a major failure and compensation for any other reasonably foreseeable loss or damage. You are also entitled to have the goods repaired or replaced if the goods fail to be of acceptable quality and the failure does not amount to a major failure.
Australian sponsor:

• Emergo Australia
• Level 20, Tower II, Darling Park,
• 201 Sussex Street, Sydney, NSW 2000 Australia
• Authorized Representative and Importer for Switzerland
• MedEnvoy Switzerland
• Gotthardstrasse 28 – 6302
• Zug – Switzerland
• Withings BPM Core
• Wi-Fi Smart Blood Pressure Monitor
• V3.0 – Nov. 2023

© 2023 Withings. All rights reserved.

References

• ings.com
• ings.com/support
• Withings | Smart Scales, Watches and Health Monitoring Devices
• Smart Scales, Watches and Health Monitoring Devices | Withings
• Compliance documents | Withings

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