WITHINGS HWA09 Smartwatch Scan Monitor Instruction Manual

WITHINGS HWA09 Smartwatch Scan Monitor

Scan Monitor Product Information and Usage Instructions

The Scan Monitor is a device that allows users to take electrocardiogram (ECG) and oxygen saturation (SpO2) readings using a Withings ScanWatch and a smartphone with iOS 12 or later, or Android 8 or later. The device is activated during the Association of ScanWatch and the Health Mate application. The ECG recording results are displayed on the ScanWatch and on the Health Mate app.

Using the Scan Monitor

Set-Up

Before using the Scan Monitor, ensure that your Withings ScanWatch is snug on the wrist you selected in Devices > ScanWatch > More settings> Device Orientation. The ScanWatch is a connected watch, distributed without ECG function.

•  Withings ScanWatch is a connected watch, distributed without ECG function
•  Scan Monitor is activated during the Association of ScanWatch and the Health Mate application
•  Scan Monitor is only available for Withings ScanWatch, paired with a smartphone with iOS 12 or later, or Android 8 or later.

On-boarding

To begin using the Scan Monitor, open the Withings Health Mate app and tap + in the timeline tab, then select Electrocardiogram (ECG). Follow the onscreen instructions to complete the on-boarding process. You may exit on-boarding at any time by pressing Cancel.

• Open Withings Health Mate app.
•  In the timeline tab, tap “+”, then select “Electrocardiogram (ECG)*
•  Follow the onscreen instructions.
•  You may exit on-boarding at any time by pressing “Cancel”.

How to take an ECG recording

1. Rest your arms on a table and hold the top electrode with your second hand (with your thumb and index for example, as shown . You do not need to press the bezel during the session.
2. Make sure to follow the gesture indicated in the best practice article within the mobile application in order to obtain an ECG with good signal quality.
3. The recording starts after the first vibration and lasts for 30 seconds.
4. End of measurement is confirmed by a double vibration.

•  Make sure your ScanWatch is snug on the wrist you selected in Devices > ScanWatch > More settings> Device Orientation.
•  Rest your arms on a table and hold the top electrode with your second hand (with your thumb and index for example, as shown on fig. 05-1). You do not need to press the bezel during the session.
•  Make sure to follow the gesture indicated in “the best practice” article within the mobile application in order to obtain an ECG with a good signal quality
• The recording starts after the first vibration.
• The recording lasts for 30 seconds.
•  End of measurement is confirmed by a double vibration.
• After a successful reading, you will receive one of the following classifications on your Scan Monitor:

If still < 90, seek medical attention urgently

• Sinus Rhythm: a sinus rhythm result means the heart is beating in a uniform pattern between 50-100 BPM.
• Atrial Fibrillation: an AFib result means the heart is beating in an irregular pattern above 50 BPM.
• Inconclusive: An inconclusive result means the recording can’t be classified. This can happen for many reasons such as not resting your arms on a table during a recording, or your ScanWatch is too loose. Certain physiological conditions may prevent a small percentage of users from creating enough signal to produce a good recording.
• Low or High Heart Rate: A heart rate under 50 BPM or over 100 BPM affects the ECG app’s ability to check for AFib and the recording is considered inconclusive.

All ECGs are synced to Health Mate on your Android or iOS smartphone. You may use the Health Mate app to share your ECG with a clinician.

How to take an SpO2 recording

To take an SpO2 recording, follow the same process as taking an ECG recording, but hold your finger on the watch’s optical sensor instead of holding the top electrode with your second hand. for guidance on how to place your hand for an accurate reading.

• Tighten the band so that the back of the watch is in contact with the skin of the wrist.
• Rest your arm on a table, with the hand relaxed and in an open position
• Activate the Sp02 measure using the watch interface
•  The recording starts after a first vibration
•  The recording lasts 30 seconds, do not talk or move during the measurement
• The end of the measurement is confirmed by a double vibration
• If the measurement fails, restart from the beginning and slightly push the watch with your right hand

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 INDICATIONS FOR USE

Scan Monitor is a medical device composed of software and the dedicated hardware of a reusable wrist applied device, the Scan Watch, which incorporates a lead I electrocardiograph (ECG), and a reflectance photoplethysmography (PPG), and a reflectance pulse oximetry sensor. Scan Monitor is intended to measure heart rate and to detect atrial fibrillation with a single channel electrocardiogram, and to measure pulse rate and to detect atrial fibrillation with reflectance photoplethysmogram, and to measure functional oxygen saturation of arterial hemoglobin (Sp02). It is intended for intermittent measurements. Scan Monitor measures, transfers, records, and displays a single channel electrocardiogram similar to a lead I ECG. Scan Monitor’s software detects the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable ECG waveform, calculates the heart rate, the P wave duration, the PR interval, the QT interval, the QT corrected interval, and the QRS duration. Scan Monitor measures, transfers, records and displays functional oxygen saturation of arterial hemoglobin (% Sp02). It can be used at home and in hospitals environments such as sleep labs or long-term care. Scan Monitor measures, transfers, records and displays pulse rate data and identifies episodes of irregular heart rhythm suggestive of atrial fibrillation and provides a notification to the user. The pulse rate feature can be used to supplement a clinician’s decision to screen for possible AFib. The feature is intended for over-the-counter (OTC) use.
Scan Monitor is indicated for use in adults (18 years of age or older).

ECG Analysis

•  After a successful reading, you will receive one of the following classifications on your Scan Monitor:

•  Sinus Rhythm: a sinus rhythm result means the heart is beating in a uniform pattern between 50-100 BPM.

• Atrial Fibrillation: an AFib result means the heart is beating in an irregular pattern above 50 BPM.

• Inconclusive: An inconclusive result means the recording can’t be classified. This can happen for many reasons such as not resting your arms on a table during a recording, or your ScanWatch is too loose. Certain physiological conditions may prevent a small percentage of users from creating enough signal to produce a good recording.

•  Low or High Heart Rate: A heart rate under 50 BPM or over 100 BPM affects the ECG app’s ability to check for AFib and the recording is considered inconclusive.

• After an ECG recording is complete, the ECG data is analyzed to determine if it is 30-second long, and, if so, if either Sinus Rhythm or AFib is present, or if an Inconclusive result is warranted.

• The ECG recording results on a detailed display of the result on the ScanWatch and on the Health Mate app.

• The classification of the ECG recording is for information use only. It is meant to supplement, but not replace traditional methods of diagnosis. If you are experiencing any symptoms or have concerns, contact your physician. If you believe you are experiencing a medical emergency, you should contact emergency services.

• A result of Sinus Rhythm means your heart rate is between 50 and 100 beats per minute (bpm) and is beating in a regular pattern.

• Inconclusive ECG results may be caused by too many artefacts, by movements (signal of poor quality), by too much noise parasitizing due to the proximity with an electrical device generating strong electromagnetic fields or you may have an arrhythmias other than AFib or your heart is below 50bpm or above 100bpm. A small percentage of people may have certain physiological conditions preventing the user from creating enough signal to produce a good recording. You can learn more about Inconclusive ECG results during on-boarding, by accessing educational information in the ECG area of the Health Mate app on your smartphone.

  • A heart rate can be low because of certain medications or if electrical signals are not properly conducted through the heart. Training to be an elite athlete can also lead to a low heart rate.
  • A heart rate can be high because of exercise, stress, nervousness, alcohol dehydration, infection, AFib, or another arrhythmia.
  •  If you receive an Inconclusive result due to a poor recording, you might try to re-record your ECG.
    You can review how to take an ECG during on-boarding or by tapping on “Take a Recording” in the ECG area of the Health Mate app on your smartphone.

• All ECGs are synced to Health Mate on your Android or iOS smartphone. You may use the Health Mate app to share your ECG with a clinician.

 OXYGEN SATURATION ANALYSIS

The following table for evaluating your measurements does not apply to people with certain pre-existing conditions (e.g asthma, heart failure, respiratory disease) or whilst staying at altitudes above 1500 meters. If you have a pre- existing condition, always consult your doctor to evaluate your measurements.

•  After a successful measurement, you will receive one of the following classifications on your Scan Monitor:
•  If results are above 90%, the functional oxygenation of your blood is considered as normal. In the case where results are often comprised between 90% and 94%, it is still normal but below average. These results can vary based on a number of many factors, including but not limited to your health profile (whether you are a smoker, if you are very athletic or not, if you have tattoos), your environment (altitude, temperature) the way the measurement is done. We suggest you to check best practices and train to improve your gesture as indicated within the mobile application.
•  If results are below 90%, the value can be a possible sign of hypoxia (low oxygen level in your red blood cells). We suggest you to check for best practices and repeat the measurement. In case of results associated with symptoms, contact your doctor or a healthcare professional. Symptoms include being short of breath after exertion, coughing, fast or slow heart rate, rapid breathing, sweating.
• A cross will be displayed on the watch in the case where the Sp02 could not be calculated. It can be the results of short measurement (less than 30 seconds), invalid way of taking the measurement (refer to best practices) or because of factors described within the Section Warnings of this document.
•  The SpO2 recording results appear on a detailed view on the ScanWatch and on the Health Mate app after synchronization.
•  The classification of the SpO2 recording is for information use only. It is meant to supplement, but not replace traditional methods of diagnosis. If you are experiencing any symptoms or have concerns, contact your physician. If you believe you are experiencing a medical emergency, you should contact emergency services.
•  All SpO2 values are synced to Health Mate on your Android or iOS smartphone. You may use the Health Mate app to share your results with a clinician.

essential
5800-7500m| <80| Severe hypoxia, only limited length of  stay  possible

 TECHNICAL SPECIFICATIONS

 SAFETY AND PERFORMANCE

The Scan Monitor software’s ability to accurately classify an ECG recording into Afib and sinus rhythm was tested against the IC 60601-2-47 standard and clinical data of 168 subjects The Scan Monitor demonstrated 98.16 % sensitivity in classifying AFib and 97.20 % specificity in classifying sinus rhythm in classifiable recordings of 5 public databases. Rhythm classification from Scan Monitor was compared to ECG labeled by cardiologist on the clinical data. During this clinical study, 20.2% of recordings were inconclusive and not classifiable as either sinus rhythm or AFib. The Scan Monitor reached 100.0 % sensitivity in classifying AFib and 100.0 % specificity in classifying sinus rhythm among the remaining classifiable recordings. These results reflect use in a controlled environment. Real world use of the Scan Monitor may result in a greater number of strips being deemed inconclusive. The waveform output from the software was tested in accordance with IC 60601-2-47 standard by a beat-to-beat QRS detection. This detection reaches a Fl-score of at least 99,19% on all the datasets with the exception of NSTDB (90,65% because of the digitally added noise).
**JEC 60601-2-47:2012: Requirements for the Basic Safety and Essential Performance of Ambulatory Electrocardiographic Systems.

• PE Statement

Guidance and manufacturer’s declaration-electromagnetic emissions

The Scan Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Scan Monitor should assure that it is used in such an environment
Emissions test| Compliance| Electromagnetic environment-guidance
CE emissions CISPRll| Group 1| The Scan Monitor 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 CISPRll| Class B
Harmonic emissions IEC 61000-3-2| Not applicable| The Scan Monitor 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 em1ss1ons
IEC 61000-3-3

•  Declaration- electromagnetic emissions and immunity for equipment and systems that are not life-supporting and are specified for use only in a shielded location

 TROUBLESHOOTING

If you experience difficulties in operating your Scan Monitor, refer to the troubleshooting guide below.

 Troubleshooting for ECG measurements

Problem 7.1.1: I cannot get the Scan Monitor to take an ECG reading.
Solutions:

•  Make sure your wrist and your ScanWatch are clean and dry. Water and sweat can cause a poor recording.
•  Ensure that your ScanWatch, arms, and hands remain still during recordings.
• Ensure that you have completed all of the on-boarding steps in the Health Mate app on your smartphone.

Problem 7.1.2: I have an inconclusive measure. It looks like the ECG measure presents a lot of artifacts, noise, or interference in my recording.
Solution:

• Rest your arms on a table while you take a recording. Try to relax and don’t move too much.
• Tighten the band so that the back of the watch is in contact with the skin of the wrist. When moving the watch slightly, the skin in contact with it should move with it.
• Move away from any electronics that are plugged into an outlet to avoid electrical interference.

Problem 7.1.3: The ECG waveforms appear upside down.
Solution:

• The device orientation may be set to the wrong wrist. On your smartphone, go to the Health Mate app. Tap Devices > More Settings > Device Orientation.

All data recorded during an ECG measurement is saved to the Health Mate app on your smartphone. If you choose to, you can share that Information by creating a PDF.

 Troubleshooting for Sp02 measurements

Problem 7.2.1: The ScanWatch indicates that I am not staying still during SpO2 measurements.
Solution:

•  Ensure that your ScanWatch, arms, and hands remain still during recordings.
•  Ensure that your hand is comfortably resting on a flat surface.
• Do not move or talk during the entirety of the measurement.

Problem 7.2.2: I have an inconclusive Sp02 measurement.
Solution:

•  Ensure that you have completed all of the on-boarding steps in the Health Mate app on your smartphone.
•  Rest your arms on a table while you take a recording. Ensure that your palm is open and try to relax your hand.
•  If you have low skin perfusion (for instance due to low temperatures), scrub your wrist at the watch location to increase skin perfusion.
• Make sure that your ScanWatch is not loose on your wrist. Tighten the band until it is snug but comfortable, and the watch stays in place even when you are moving. Wearing the watch closer to the elbow can help obtain a better fit.
• Push slightly on the top of the watch with two fingers to improve the contact between the skin and the watch.
• Flexible strap (silicone or FKM type) helps to better fit your watch around your wrist and thus more easily obtain a conclusive result.

CLEANING AND DISPOSAL

 Cleaning ScanWatch

• Use a lint-free cloth moistened with warm water to clean the top housing and casing of your ScanWatch
• Run the wrist band under warm water and rub it with hypoallergenic soap to clean it
•  Dry the wrist band with a soft cloth

 Disposal

ScanWatch is classified as an electrical and electronic equipment. Such items should not be mixed with general household waste and must be taken to dedicated collection points at the end of their working life for proper treatment, recovery and recycling.

 CONTRAINDICATIONS

Scan 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. Scan Monitor does not provide alarms. Scan Monitor is not intended to provide or to replace a diagnosis by a physician or qualified health care professionals. Vital signs measurements, such as those taken with this device, cannot identify all diseases.
Scan Monitor is not indicated for use:

• On patients with a pacemaker or other implanted electronic device
•  On patients diagnosed with an arrhythmia other than atrial fibrillation
•  For out-of-hospital transport by emergency medical services
•  During medical procedure

WARNINGS
Regardless of the measurement taken using this device, you should consult your doctor immediately if you experience symptoms that could indicate acute disease. Scan monitor cannot detect heart attacks or ischemic heart conditions. if you ever experience chest pain, pressure, tightness or what you think is a heart attack, call emergency services.
DO NOT self-diagnose or self-medicate on the basis of this device without consulting your doctor. in particular, do not start taking any new medication or change the type and/or dosage of any existing medication without prior approval.
Withings does not guarantee that you are not experiencing an arrhythmia or other health conditions even in the absence of a notification from the pulse rate feature. you should notify your physician if you experience any changes to your health. the pulse rate feature is not constantly looking for an afib and should not be relied on as a continuous monitor. this means the feature cannot detect all instances of afib, and people with afib may not get a notification.
The functional oxygen saturation feature is not constantly looking for blood oxygen desaturation and should not be relied on as a continuous monitor. Factors that may degrade performance of reflectance pulse oximetry and heart rhythm analysis via photoplethysmography include:

• Bright sunlight
• Presence of strong electromagnetic fields
• Failure to apply the device correctly (loose wristband application, not on top of the wrist)
•  Tattoos at the wrist in the region of the optical sensor
•  A dark-skin tone
• Excessive motion of the arm, of the wrist and of the fingers
• Low perfusion caused by ambient temperature below the recommended operation range, or by certain conditions such as Raynaud’s syndrome
• Significant levels of dysfunctional hemoglobin (carboxyhemoglobin, methemoglobin)
• Venous pulsations
•  Intravascular dyes such as cardiogreen or methyl blue
• Blood flow restrictions due to arterial catheters, blood pressure cuffs, infusion lines etc.
• Patient suffering from hypotension, serious vasoconstriction, serious anemia, hypothermia
•  Patient in cardiac arrest or in shock

A functional tester cannot be used to access the accuracy of pulse oximeter devices Misapplication of the ScanWatch with excessive pressure and for a prolonged period can cause pressure injury. Avoid application of the ScanWatch to a wrist with poor skin integrity DO NOT sterilize by irradiation, steam or ethylene oxide- refer to cleaning and disinfection instructions. Use of cleaning agents other than specified may damage the device. DO NOT use the ScanWatch if it is damaged- use of a damaged device could cause patient injury or equipment failure. DO NOT take recordings when ScanWatch is in close vicinity to strong electromagnetic fields (e.g. electromagnetic anti-theft systems, metal detectors). DO NOT take recordings during a medical procedure (e.g., magnetic resonance imaging, diathermy, lithotripsy, cautery and external defibrillation procedures). DO NOT take recordings when ScanWatch is outside of the operational temperature range (5°C – 40°C) indicated in the ScanWatch user manual and humidity range of 20% to 90% relative humidity. DO NOT use to diagnose heart-related conditions. DO NOT use with a cardiac pacemaker, ICDs, or other implanted electronic devices DO NOT take a recording during physical activity.
NOTE:
The measure of Sp02 in the range 70-100% has been clinically validated on healthy adult volunteers, al rest against a laboratory co-oximeter.
The device is conforming to IP22 requirements This device has no alarm system in case of low saturation.
CAUTION: Withings does not guarantee that you are not experiencing an arrhythmia or other healt conditions when the Scan Monitor labels an ECG as Sinus Rhythm. You should notify your physician if you detect possible changes in your health.

EQUIPMENT SYMBOLS

Australian Sponsor:
Emergo Australia, Level 20, Tower II
Darling Park, 201 Sussex Street- Sydney, NSW 2000
Australia
UK Responsible Person
Emergo Consulting (UK) Limited
c/o Cr360 – UL International, Compass House,
Vision Park Histon, Cambridge CB24 9BZ, United Kingdom

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