WITHINGS ECG Monitor Instruction Manual

INSTRUCTIONS FOR USE

INSTRUCTIONS FOR USE NON-US REGIONS

This manual explains how to use the Wittings ECG Monitor with your Witlings Body Scan.

Important notice

Instructions for Use of the Withings Body Scan are described in the Product Guide provided with the product.
Please read the following information carefully before using Withings ECG Monitor.
Please contact Withings when in need of assistance, setting up, using or maintaining the device or to report unexpected operations or events.
Any serious incident that has occurred in relation to the Withings ECG Monitor should be reported to Withings and competent authorities in your country of residence.

Disclaimer
Information in this guide may change without notice.

**** WITHINGS,
2 rue Maurice Hartmann,
92130 Issy-les-Molineux,
FRANCE

Intended Use (Non-US Regions)

The Withings ECG Monitor is a software-only device intended for use with the Withings Body Scan to create, record, store, transfer and display lead II and lead-III of a two-channel electrocardiogram (ECG). In addition, it calculates and displays leads I, aver, alfa, Val.
The Withings ECG Monitor determines the presence of atrial fibrillation (AFib), sinus rhythm, and high heart rate (no signs of AFib but a sinus rhythm with heart rate between 100-150 bpm) on a classifiable waveform.
The Withings ECG Monitor is not recommended for users with other known arrhythmias. The Withings ECG Monitor is intended for over-the-counter (OTC) use. The ECG data displayed by the Withings ECG Monitor is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment.
The Withings ECG Monitor is intended for use by an adult population.

Contraindications

DO NOT use the Withings ECG Monitor with a cardiac pacemaker, ICD, or other implanted electronic devices.

Cautions

• The Withings ECG Monitor cannot check for signs of heart attacks  or ischemic heart conditions. If you experience chest pain, pressure,  tightness or what you think is a heart attack, call emergency  services. If you believe you are having a medical  emergency, call  emergency services.

• DO NOT take recordings when Withings Body Scan is in close  vicinity to strong electromagnetic fields.

• Interpretations made by Withings ECG Monitor are potential  findings, Withings ECG Monitor cannot diagnose cardiac conditions.
  The user is not intended to interpret or take clinical action based  on the device output without consultation of a qualified healthcare  professional.

• The waveform generated by Withings ECG Monitor is meant to  supplement rhythm classification for the purposes of discriminating  Afib from normal sinus rhythm and tachycardia (high heart rate)  and not intended to replace traditional methods of  diagnosis or  treatment.

• The Withings ECG Monitor cannot detect all instances of Atrial
  Fibrillation. You should contact your physician if you experience any  changes to your health.

• DO NOT self-diagnose or self-medicate on the basis of this device.
  In particular, do not start taking any new medication or change  the type and/or dosage of any existing medication without prior  approval of your physician.

• Withings ECG Monitor is not intended to identify heart-related  conditions other than Afib.

• DO NOT take recordings when Withings Body Scan is outside of  the operational temperature range and humidity range indicated  in the product guide.

• The Withings ECG Monitor is not intended to continuously monitor  vital signs in critical conditions or where the nature of the variations  is such that it could result in immediate danger to the patient.
  Withings ECG Monitor does not provide alarms.

Using Withings ECG Monitor with Withings Body Scan

On-boarding for new Withings’ users:
Before being able to use the Withings ECG Monitor with the Withings Body Scan, you will need to download the Withings app and create an account.

• Only use official app stores to download the Withings app.
  To ensure that the app is the official Withings space,  use the following link: https://go.withings.com

• The Withings app is compatible with smartphones or tablets  with iOS 14 or later, or with Android 8 or later;

• Use a trusted Wi-Fi network with your Withings app. Do not  use a public Wi-Fi network you don’t know;

• The mobile application is not intended to be used on a computer.
  No anti-virus software is needed.

You are now ready to set up the scale Withings Body Scan with the Withings app on your iOS or Android device. Please note that the Withings ECG Monitor is only compatible with Withings Body Scan.

Setup:

• Once you have downloaded the Withings app from an official  store (App store and Google Play store), open the app — see  previous page for more information.
• In the Devices tab, select “Install a device,” then select “Scales.”
• Select the product “Body Scan.”
• Follow the on-screen instructions. You will be prompted to pair  your device via Bluetooth.
• After pairing, a tutorial section will be available. Follow the ECG  tutorial in order to activate Withings ECG Monitor.
• You may exit onboarding at any time by tapping Cancel.

Recording an ECG

How to take an ECG recording:

1. Make sure the Withings Body Scan is on a stable surface, and that you activated and enabled the ECG measurement in the Withings app (see “How to enable ECG Measurement?” section).
2. Grab the handle. Hold the handle in both hands, taking care that the part of the handle marked with an “L” is in your left hand and that the part of the handle marked with an “R” is in your right hand. Make sure both hands touch the metallic electrodes on the back of the handle. The handle should be held with the cable positioned vertically, as shown in the figure below.
3. Step on the scale with bare feet. Make sure your feet are centered on the scale’s stripes (electrodes).
4. Keep your arms along the side of your body and relax. You do not need to grip the handle very tightly.
5. A series of measurements will start depending on the configuration you chose in the application (see page 04 “Using Withings ECG Monitor with Withings Body Scan”). You will know that the ECG measurement has begun when the ECG recording screen is  displayed on the scale LCD screen and after the first vibration. Do not speak or move during the JECG recording.
6. It takes 30 seconds to complete a recording.
7. Wait for the measurement to end. A countdown indicates the remaining time.
8. When the measurement is complete you will feel a double vibration.

What is a 6-Lead ECG?

How Withings ECG Monitor obtains an ECG:

• An ECG, or electrocardiogram, is the graphical representation  of the electrical activity of the heart. With each heartbeat,  an electrical wave travels through your heart. This wave causes  your heart to contract and pump blood.
• In a doctor’s office, a standard 12-lead ECG is usually taken b  by placing electrodes on your arms, legs, and torso. A lead  measures the difference of electric potential between a pair of  electrodes. Each lead measures this from a different angle.
• The Withings ECG Monitor uses electrodes from the Withings  Body Scan to record a 6-lead ECG. Electrodes are in contact  with the hands and feet.
• A 6-lead ECG is able to provide information about heart rate  and certain heart rhythms: Sinus rhythm and Atrial Fibrillation  (Fib). 6-lead ECGs are sometimes prescribed by doctors for  people to wear at home or within the hospital so that the  doctor can get a better look at the underlying rate and rhythm  of the heart.

ECG Outputs

ECG classification:
After an ECG recording, you will see one of the following classifications for the recording:

• Low Heart Rate (heart rate < 50 bpm)
• High Heart Rate (heart rate > 150 bpm)
• Sinus Rhythm (heart rate between 50-99 bpm)
• High Heart Rate (No signs of AFib) (heart rate between 100-150 bpm)
• Atrial Fibrillation (heart rate between 50-99 bpm)
• Atrial Fibrillation — High Heart Rate  (heart rate between 100-150 bpm)
• Inconclusive
• Poor Recording

After the ECG recording you will also see your average heart rate and your ECG tracing.

ECG Outputs

Low Heart Rate
A Low Heart Rate result means your heart is beating less than 50 beats per minute (bpm). This recording cannot be classified by Withings ECG Monitor.
A low heart rate can happen if electrical signals are not properly conducted through the heart. Some medicines can also cause a low heart rate. Some elite athletes may also have a low heart rate.
Talk to your doctor if you have questions about your ECG recording.

High Heart Rate
A High Heart Rate result means your heart is beating above 150 beats per minute (bpm). This recording cannot be classified by Withings ECG Monitor.
Many different things can cause a high heart rate. A heart rate may be high because of exercise, stress, dehydration, infection, Fib, another arrhythmia or another cause.
Talk to your doctor if you have questions about your ECG recording.

Sinus Rhythm
A Sinus Rhythm result means your heart rate is between 50 and 99 beats per minute (bpm) and is beating regularly.

High Heart Rate (No signs of AFib)
A High Heart Rate (No signs of Fib) result means the heart rate is beating between 100 and 150 beats per minute (bpm) and does not show any signs of Atrial Fibrillation.
Many different things can cause a high heart rate. A heart rate may be high because of exercise, stress, dehydration, infection, an arrhythmia, or another cause.
Talk to your doctor if you have questions about your ECG recording.

Atrial Fibrillation
An Atrial Fibrillation result means the heart rate is between 50 and 99 beats per minute (bpm) and is beating irregularly. If you have not been diagnosed with Fib before, you should talk to your doctor.

Atrial Fibrillation – High Heart Rate
An Atrial Fibrillation — High HR result means your heart rate is beating between 100 and 150 beats per minute and is beating with an irregular pattern.
If you have not been diagnosed with Fib before, you should talk to your doctor.

Inconclusive
An Inconclusive result means that the signal cannot be classified as Sinus Rhythm or Atrial Fibrillation, although the quality of the recording is good.
This may be due to various conditions, including but not limited to other arrhythmias or other heart conditions. Talk to your doctor if you have questions about your ECG recording.

Poor Recording
A Poor Recording result means the recording quality is low and the ECG cannot be classified. This may be caused by errors during the measurement. Some things that can cause this type of result are: excessive movement that causes a signal of poor quality; OR proximity to an electrical device that generates strong electromagnetic fields; not holding the handle correctly; or not correctly positioning your feet on the scale. A small percentage of people may have certain physiological conditions that prevent them from creating enough signal to produce a quality recording. You may try to re-record your ECG. You can review how to take an ECG during setup or by tapping Take a Recording in the ECG section of the Health Mate app on your smartphone.

Sharing ECG Results

How to share your ECG with your doctor:
Once the ECG measurement feature is activated (see page 04 “Using Withings ECG Monitor with Withings Body Scan”), the results of the ECG can be shared with a physician as a PDF, generated by the Withings app.
The pdf includes the following information:
– The ECG strip for the 6 Leads
– The average heart rate
– The classification of the ECG according to the detection algorithm.

How to enable ECG Measurement?
– First, make sure your Withings Body Scan is configured  properly and that you have activated Withings ECG Monitor by  following the tutorial in the Withings app.
– In order to activate or deactivate ECG measurement, go in  the settings tabs of the application and find your device and  select “Customize Screens.”
– In the list you should be able to see “ECG 6-Lead.” You can  select the measurement by tapping on it. A check mark will be  shown next to the measurement when activated.
–  Please take into consideration that the scale will need to be  synchronized once before the change is applied to your device.
Performing an ECG measurement will apply the changes to  your device. If you don’t perform an ECG measurement,  the changes will be applied to your device during a routine  synchronization overnight.

Safety and Performance

The Withings ECG Monitor contributes to an early detection of atrial fibrillation, facilitates patient screening and helps physicians treat the disease earlier and thus attenuates the impact of the disease on the population. It also contributes to an increased awareness of physiological conditions.
Withings ECG Monitor’s ability to accurately classify an ECG recording into Atrial Fibrillation and Sinus Rhythm categories was tested in a clinical study.
Rhythm classification by Withings ECG Monitor was compared to the review by cardiologists of simultaneously recorded 12-lead ECG. The study included 233 patients. 90.3% of recordings were conclusive (i.e. neither “inconclusive” nor “poor recording”). On conclusive recordings, the sensitivity in classifying Atrial Fibrillation was 98% (lower bound of the 95% confidence interval: 92%) and the specificity in detecting normal sinus rhythm was 100% (lower bound of the 95% confidence interval: 98%).
The accuracy of heart rate measured from the ECG was also assessed in this clinical study. The mean difference between the algorithm calculated heart rate from Withings ECG Monitor’s strips and the heart rate measured by cardiologists on the 12lead ECGs was -1.1 bpm (standard deviation 3.3 bpm).
The performance of the ECG function passed the applicable requirements on ECG waveform and heart rate measurements specified in ANSI/AAMI/IEC 60601-2-47:2012 Requirements for the Basic Safety and Essential Performance of Ambulatory Electrocardiographic Systems and ANSI/AAMI EC57:2012 (R2020) Testing And Reporting Performance Results Of Cardiac Rhythm And ST Segment Measurement Algorithms.

Troubleshooting — Syncing with Withings App

Scan appears in Devices in  the Withings app. If not, please install it.
– Make sure your Withings Body Scan has enough battery life.
Recharge your scale if necessary using the included USB-C power  cable. When plugged in, your Withings  Body Scan will display the  percentage of battery left.
–  If your Withings Body Scan is configured with Wi-Fi, make sure  your router is plugged in, that your Wi-Fi  is operational and that  the scale is in range of your router.
–  If necessary, reboot your scale. Press and hold the button of your  scale for 15 seconds.
– If necessary, reboot your mobile phone.

Troubleshooting — ECG

If you experience difficulties with operating your Withings ECG Monitor, refer to this troubleshooting guide.
If you cannot fix the problem using the troubleshooting instructions, please contact Withings.

you have completed all of the setup steps  in the Withings app on your smartphone.
– Ensure that your legs, feet, arms, hands and fingers remain still  during recordings and that your feet and fingers are in contact  with the electrodes.
– Ensure that no rings or other jewelry are touching the electrodes.
– Make sure the glass plate and handle of your Withings Body Scan  are clean and dry. Make sure that your hands and feet are dry.
Water and sweat can be the cause of a poor quality ECG.
I have an inconclusive measurement.
It looks like the ECG recording has a lot of artifact, noise, or interference.| – Ensure that your legs, feet, arms, hands and fingers remain still  during recordings and that your feet and fingertips are in contact with the electrodes.
– Try to relax and not to move.
– Make sure the glass plate and handle of your wrist and your  Withings Body Scan are clean and dry. Make sure that your hands and  feet are dry.  Water and sweat can be the cause of a poor quality ECG.
– Move away from any electronics that are plugged into an outlet to  avoid electromagnetic interference.
– Remove any ring you might be wearing.
The ECG waveforms appear upside down.| – The handle may be held with the left electrode in the right hand  and the right electrode in the left hand.

Security

Withings recommends that you add a passcode (personal identification number [PIN]), Face ID or Touch ID (fingerprint) to your phone to add a layer of security. It is important to secure your phone since you will be storing personal health information. Users will also receive additional update notifications on the device via the app, and updates are delivered wirelessly, encouraging rapid adoption of the latest security fixes. Users are able to see the current installed software version in the Withings app, in Devices > Withings Body Scan. This tab also indicates if an update is available or not. Do not install the device on a smartphone that you do not own.
Do not use a public Wi-Fi network you don’t know. Use a trusted Wi-Fi network with your device. Withings recommends upgrading your application and your device when an upgrade is available.

Europe – EU Declaration of Conformity
Withings hereby declares that the device Withings ECG Monitor is in conformity with the general safety and performance requirements of the applicable Medical Devices Regulation (EU) 2017/745. The full text of the EU declaration of conformity can be found at: withings.com/compliance

1282| The CE labeling certifies that the product complies with the general safety and performance requirements of Medical Device Regulation2017/745

Australian sponsor
Emergo Australia
Level 20, tower II, Darling Park, 201
Sussex Street,
Sydney, NSW 2000,
Australia
UK Responsible Person
Emergo Consulting (UK) Ltd c/o
Cr360 – UL International
Compass House, Vision Park Hitson
Cambridge CB24 9BZ
United Kingdom
Med Envoy Switzerland
Gotthardstrasse 28
6302 Zug
SWITZERLAND
Withings Body Scan | Proactive Health Tracking © 2023 Withings.
All rights reserved. Jan. 2023
support.withings.com – 2 rue Maurice Hartmann, 92130 Issy-les-Molineux, France

References

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

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