WITHINGS BPM Core Electric Arm Blood Pressure Monitor User Guide

PRODUCT GUIDE

BPM Core Electric Arm Blood Pressure Monitor

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 residence.
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.
WITHINGS,
2 rue Maurice Hartmann,
92130 Issy-les-Moulineaux,
FRANCE
+33141460460
Distributed by Withings Inc.,
179 South Street, Floor 5
Boston, MA 02111 USA

Intended use

Withings BPM Core is a digital monitor intended for use in measuring blood pressure and heart rate, to record a one-lead ECG to detect atrial fibrillation, and to uncover 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.

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 with 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 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.
– 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, aorto-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 Sounds 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, arm and back supported.
   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 measurement, 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.

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 measurement is 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

1. 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.
2. If an error message appears on screen, please refer to the explanation displayed in the app and 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 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 are 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.

| Sensitivity(%)| Specificity
---|---|---
Atrial fibrillation| 94.57| 93.56
| Sensitivity(%)| Positive predictivity (%)
Normal sinus rhythm| 93.76| 93.78

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

Withings BPM Core outputs

fibrillation, but a complete diagnosis is not possible for a heart rate above 100
bpm. To obtain full analysis, the heart rate must be below 100 bpm during the recording.
ECG LOW HR| The heart rate obtained cannot be classified as a recording. To obtain full analysis, the heart rate must be above 50 bpm during the
recording.
ECG TOO NOISY| There is too much interference for the recording to be classified. Refer to the best practices section to know the right gestures to be
adopted and those to be avoided.
ECG
INCONCLUSIVE| Inconclusive results.

Troubleshooting

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

direct contact with the skin. If needed, clean them with a tissue.
A valvular heart disease analysis cannot be performed| Check the position of the stethoscope. The flat surface must be in contact with the chest. Ensure that you performed the
required number of measurements to get a reading.
The inflation action cannot be performed or the air pressure cannot rise| 1. Check the cuff position, fasten the cuff correctly and remeasure blood pressure again
2. Check the blood pressure monitor’s connection to the iOS or Android device
The low battery icon is displayed on the device| Charge the device with the cable provided
The blood pressure cannot be taken and the application shows an error message| 1. Re-fasten the cuff
2. Relax and sit down
3. Keep the cuff at the same level as your heart during the measurement period
4. Keep silent and still during the measurement
5. If you have a severe heartbeat problem, the blood pressure may not be read correctly
Under normal circumstances, the measurement taken at home may differ from the measurement taken in a medical setting| 1. The variation is due to the different environments
2. The blood pressure is changing according to the physiological or psychological status of the person being measured
3. Atrial fibrillation may not be permanent in its early stages
4. Show your recorded values to your physician

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): O to 285 mmHg, DIA 40 to 1530 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 vali- dated 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-~-lO6kpa, Max altitude: 2000m
Arm type: Use on 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 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 receiver.
– Connect the equipment into 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

Guidance and manufacturer’s declaration — electromagnetic emissions
This smart blood pressure monitor with ECG & digital stethoscope is intended for use in the electromagnetic environment specified below. The customer or the user of the smart blood pressure monitor with ECG & digital stethoscope should ensure that it is used in such an environment.

Emissions test| Compliance| Electromagnetic environment — guidance
---|---|---
CE emissions CISPR11| Group 1| This smart blood pressure monitor with ECG & digital stethoscope 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.
RE emissions CISPR11| Class B
Harmonic emissions IEC 61000-3-2| Not applicable| This smart blood pressure monitor with ECG & digital stethoscope 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.
Voltage fluctuations/ Flicker emissions IEC 61000-3-3| Not applicable

Declaration – Electromagnetic emissions and immunity

For equipment and systems that are not life-supporting and are specified for use only in a shielded location.
Smart blood pressure monitor with ECG & digital stethoscope declaration of electromagnetic immunity
This smart blood pressure monitor with ECG & digital stethoscope is intended for use in the electromagnetic environment specified below. The customer or the user of the smart blood pressure monitor with ECG & digital stethoscope should ensure that it is used in such an environment.

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
---|---|---|---
Conducted RFIEC 61000-4| 3 Vrms 150 kHz to 80 MHz| N/A| N/A
Radiated RF IEC 61000-4-3| 3 V/m  80 MHz to 2.5 GHz| N/A| Portable and mobile RF communications equipment should be used no closer to
any part of the equipment or system, including cables, than the recommended separation distance calculated  from the equation applicable to the frequency of the transmitter.
Interference may occur in the vicinity of equipment marked with the following symbol  .

Disposal

Actuation of European directive 2012/19/EU, for reduction in use of dangerous substances in the electric and electronic device 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 to 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 licence-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

| Manufacturer
WITHINGS, 2 rue Maurice Hartmann, 92130 Issy-les-Moulineaux, FRANCE +33141460460
---|---
| CE Marking
| Ingress of water or particulate matter
| Keep Dry
| Temperature limit
| Atmospheric pressure limitation
| Humidity limitation
| Waste Electrical and Electronic Equipment
| Type BF Applied Part (cuff)
****| Direct current
| Read this manual before use
| RCM Regulatory Compliance Mark

Frequency band : 2402 – 2480 MHz 12822460
Maximum output power: 4.45 dBm
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
AW_PRODUCT_GUIDE_WPM04_INT_A
Withings BPM Core | Wi-Fi Smart Blood Pressure Monitor | V3.0 – Nov. 2023
© 2023 Withings. All rights reserved.

References

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

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