ScanWatch Nova - Smartwatch WITHINGS - Free user manual and instructions

USER MANUAL ScanWatch Nova WITHINGS

WITHINGS SCANWATCH NOVA

PRODUCT GUIDE

EN

FR

DE

USER GUIDE

EN - NON - US REGIONS

This leaflet explains how to use the Withings ScanWatch NOVA.

WITHINGS, 2 rue Maurice Herlener, 2213D. oxy-bis-Moudensoux, FRANCE + 2214148048D

Important notice

Before using Withings ScanWatch NOVA, review the information in this guide. You may also find this guide online at: https://www.withings.com/guides.

Retain this documentation for future reference.

Installation instructions are available with the Quick Start Guide provided with this Product Guide.

Please contact Withings if you need assistance, setting up, using or maintaining the device or need to report unexpected operations or events. Any serious incident that has occurred when using Withings ScanWatch NOVA should be reported to Withings and appropriate authorities in your country of residence.

Disclaimer: Information in this guide may change without notice.

Intended Use (Non-US Regions)

Withings ScanWatch NOVA is a medical device composed of software and the dedicated hardware of a reusable wrist applied device, which incorporates a single lead electrocardiograph (ECG) and a reflectance photoplethysmograph (PCG). It is intended for intermittent measurements. Withings ScanWatch NOVA measures, transfers, records, and displays lead I of an ECG. It calculates the heart rate and detects the presence of AF or sinus rhythm on a classical ECG waveform. Withings ScanWatch NOVA measures, transfers, records and displays pulse rate to identify episodes of irregular heart rhythm suggestive of AF and provides a

notification to the user. It can be used to supplement a clinician's decision to screen for possible AF. Withings ScanWatch NOVA is indicated for over-the-counter (OTC) use in adults. Withings ScanWatch NOVA is not recommended for users with other known arrhythmias.

Contraindications

DO NOT use the ECG and irregular heart rhythm notification features if you have a cardiac pacemaker, implantable cardiac-defibrillator, or other implanted electronic device.

This irregular heart rhythm notification feature cannot detect heart attacks. If you ever experience chest pain, pressure, lightness, or what you think is a heart attack, call emergency services.

The Irregular Rhythm Notification Feature is not constantly looking for AF and should not be relied on as a continuous monitor. This means the feature cannot detect all instances of AF and people with AF may not get a notification.

This assessment carried out by this product is not a diagnosis. The data displayed by the Withings ScanWatch NOVA is intended for informational use only, and is not intended to replace traditional methods of diagnosis or treatment.

Regardless of the measurements taken using this device, you should consult your doctor immediately if you experience symptoms that could indicate you are experiencing a sudden and/or severe change in health.

DO NOT self-diagnosis 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 from a healthcare professional.

The device is not intended to continuously monitor vital physiological parameters in critical conditions or where the nature of the variations is such that it could result in immediate danger to the user. The device does not provide alarms.

Warnings

E

Before using this equipment, be sure to read this manual carefully.

Your device uses Bluetooth technology. Keep your Withings ScanWatch NOVA device more than 15 cm away from any implanted medical devices, and other devices that may be affected. Stop using your Withings ScanWatch NOVA if you suspect any interference with your medical device, and consult your physician or your medical device manufacturer as needed.

A number of factors can affect the accuracy of the pulse rate data used to identify episodes of irregular heart rhythm suggestive of AF. These include factors like body motion, hand and finger movements, wrist tattoos and decreased blood flow to your wrist (which can be caused by cold temperatures). Exposing the device to prolonged lint or dust may reduce its lifetime or damage it.

Inspect electrodes for warping, surface damage or corrosion and check for any other form of damage. Damaged electrodes or sensors may lead to incorrect measurements. DO NOT use Withings ScanWatch NOVA if it is damaged. Use of a damaged device could cause injury or equipment failure. DO NOT try to repair or modify this equipment yourself. DO NOT open or disassemble the device for battery replacement. Use of cleaning agents other than specified in this manual may damage the device.

DO NOT use accessories, detachable parts, or materials not described in the manual. Use of parts and components other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. DO NOT interconnect this equipment with other equipment not described in this manual. DO NOT take recordings when Willings ScanWatch NOVA 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, disclerency, lithography, cautery and external defibrillation procedures). DO NOT take recordings when Withings ScanWatch NOVA is outside of the operational temperature and relative humidity ranges indicated in this manual. Otherwise, measurement results may be impacted.

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device, including cables specified by the manufacturer. Otherwise this could result in degradation of performance of the Writings ScanWatch NOVA.

Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

The power cord of the charger may cause strangulation excessive length. Keep it away from children and pets.

The battery inside the watch will stop charging when the temperature is less than -10^ (+/-5°C or ) or over 50^ (+/-5°C).

If storage conditions are different from the operating conditions

indicated in the technical specifications, wait 30 minutes before using the device.

Accessory

The Withings ScanWatch NOVA is to be used with a software accessory, the Withings ScanWatch 2 companion app. It allows the installation of the watch, activates its medical features, and displays the results of performed measurements. It is part of the Withings App.

Getting started

Box Content

Charger and cable

Fluoroelastomer wristband

ScanWatch Nove Drillent

Holder

(1)

2

Note: To recharge the battery, use the provided power cord.

Band toolkit

Note: This toolkit is only suitable for a metal wristband with a folding clasp

Adjust the wristboard on your wrist or use the tape measurer provided to estimate the number of mesh links to be removed. Note that one of the links is smaller in order to adjust the bracelet more finally.

Position the wristband in the HOLDER. The arrows inside the wristband should point downward.

Band toolkit

4

Remove the second pin. Remove the mesh Repeat if necessary.

Use the pin punch and the hammer to push out the pin that supports the mesh you want to remove.

5

Reassemble the wristband by replacing one of the pins, then the other (in the opposite direction of the arrows) with the hammer.

How to use Withings ScanWatch NOVA.

Set-Up

Follow the information in the Quick Start Guide and in the Withings App to set up your device.

- To wake up your device for the first time, please press the crown. If your product is not starting, consider charging it for a minimum of two hours and to start.

- Once your product is installed and configured, it will appear in your devices list in settings.

- You may have to follow some tutorials in the Withings App in order to activate some measurements. The ECG and Irregular Heart Rhythm Notification features require you to follow boarding tutorials for their activation.

What is the Irregular Heart Rhythm Notification feature?

To activate this feature, you must follow the onboarding tutorial in the Withings App.

Withings ScanWatch NOVA can look for signs of atrial fibrillation. Every 10 minutes, your watch looks for irregular patterns in your heart rhythm in the background. Once the feature is situated, an irregular heartbest scan is launched every 10 minutes without any input from your side. As soon as an irregular heart rhythm suggestive of atrial fibrillation is detected, you'll be notified on your device and on your phone in that case, your watch will suggest taking an ECG recording.

Note: this text ("Signs of Arlib") will scroll across the watch screen.

Sign of Aflb

The quick brown fox jumps over the lazy dog.

Detected

3 days that month

How to take an ECG recording

- Make sure your Withings ScanWatch NOVA is snug on the wrist you selected during the Tutorial. To see which wrist you have chosen, on the Withings Aoc: Lep Devices > AI settings > ECG.

- Rest your arms on a table and hold the top electrode (baze) with your second hand (with your thumb and hindex for example), as shown on the future thereafter. You do not need to press the baze during the session.

- Make sure to follow the gesture indicated in "the best practice" article within the Willings App in order to obtain an ECG with a good signal quality. The recording starts after the first vibration.

The recordiq usts for 30 seconds

End of measurement is confirmed by the second vibration.

Line drawing of two hands holding wristwatches, no text or symbols present

ECG Outputs

ECG classification

After an ECG recording, you will see one of the following classifications for the recording on the watch screen (cf. left picture of the figure below) and in the Willkins App (cf. right picture of the figure below):

- Low Heart Fake (heart rate < 50 bcm)

- High Heart Rate (heart rate > 150 bpm)

- Sinus Rhythm (heart rate between 50-99 bpm)

- High Heart Rate (No signs of APlb) (heart rate between 100-150 cpm)

- Atrial fibrillation (heart rate between 50-93 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.

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 the device. 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. 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 the device. Many different things can cause a high heart rate. A heart rate may be high because of exercise, stress, dehydration, infection, AFib, another arrhythmia or another cause. Talk to your doctor if you have questions about your iCG recording.

Sinus Rhythm

A Sinus Rhythm result means your heart rate is between 50 and 90 beats per minute (lpm) and is beating regularly.

High Heart Rate (No signs of AFib)

A High Heart Rate (No signs of AFB) result means the heart rate is beating between 100 and 150 beats per minute (bpm) and does not show any signs of Atrial Florillation.

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 FCG recording.

Note: this text ("Aerial Fibrillation") will scroll across the watch screen.

Atrial Fibrillation

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

Note: this text ("Aria Fibrillation") will scroll across the watch screen.

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 AFib before, you should talk to your doctor.

Inconclusive

An inconclusive result means that the signal cannot be classified as Sinus Erythra or Atrial Fibrillation, although the quality of the recording is good. This may be due to various conditions, including but not limited to other arrhythmies 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. 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 electron-geneic fields; OR not following best practices for gestures to be adopted; 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 Withings app on your smartphone. If you think you may be having a heart attack (myocardial infarction) or are facing a medical emergency, call the emergency services.

- 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.

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

Sharing ECG Results

How to share your ECG with your doctor.

Once the ECG measurement feature is activated (see the section "How to use Willings ScanWatch NOVA" of this product guide), 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 lead I.
- The average heart rate
- The classification of the ECG according to the detection algorithm.

Troubleshooting

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

Troubleshooting for ECG measurements
Problem Solution

I cannot get the Withings ScanWatch NOVA to: Make sure your wrist and your Withings ScanWatch NOVA are clean and dry. Water and sweet take an ECG reading. - Ensure that your Withings ScanWatch NOVA, arms, and hands remain still during recordings. - Ensure that you have completed all of the on-boarding steps in the Withings app on your smartphone.

I have an inconclusive measure, it looks like that least your arms on a table who you take a recording. Try to relax and don't move too much. ECG measure presents a lot of artifacts, noise, or interference in my recording. - Tighten the band so that the back at 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. - Have away from any electronics that are plugged into an outlet to avoid electrical interference.

The ECG waveforms appear upside down. The device orientation may be set to the wrong wrist. On your smartphone, go to the Withings app, Tap Devices > More Settings > Device Orientation. All data recorded during an ECG measurement is saved to the Withings app on your smartphone. If you choose to, you can share that information by creating a PDF.

Technical specifications

Product Name: Wishings ScanWatch NOVA

Model: HWA10

ECG Sensor: For hwa10 38 mm, hwa10 42 mm and hwa10 39mm: 1 stainless steel electrode (back case electrode) & 1 Titanium Electrode (beze

electrode). For Iwal0 Rosegold, 2 stainless steel electrodes coated with TiCN/Au or 2 stainless steel electrodes for two 10 Nova 42 mm.

PPG Sensor: Red light (wavelength: 860nm) Infrared light (wavelengths: 850nm and 940nm) Green (wavelength: 530nm)

Accelerometer sensitivity: +/-4g

Battery Operated: Up to 30 days on a single charge.

Power Source: Powered internally by a 3.87 Vdc Lithium ion battery (use the charging dock and USB-C charging cable included) and a DC 5V

power adapter with a minimum power of 3W and a maximum power of 5W (not included).

Heart Rate Measurement Range (ECG feature): 30 bpm to 220 bpm

Heart Rate (Accuracy): Bias: -0.97 bpm, standard deviation: 3.3 bpm

Display OLED screen on the watch

Weight Withings ScanWatch NOVA: 63 g (38 m.n)

Operation time: 50 days typical use on a single charge

Parts in contact with the skin: Fluoroelastomer (wristisand), mineral class (lens), stainless steel (wristisand), stainless steel (case), stainless steel

(coated with TiCN/Au (case), titanium (case), sapphire glass (front glass), thermoclastic polyester elastomer (compression rinses on back case).

Transport and storage conditions: Temperature range: -25°C to 70°C. Humidity range: 20 to 90%. Pressure range: 700-1060Pa

Operation conditions: Temperature range 5°C to 35°C. Humidity range 15% - 90% Pressure range 700-1060hPa

if storage conditions are different from these operating conditions, wait 30 minutes before using the device.

Wireless Transmission: DL E

IP Protection level: IP22

Mode of operation: Continuous Operation

Expected product life: 3 years

Type BE-Applied Part: back ca

Wireless information

Wireless Specifications

Wireless Technology Bluetooth BLE

Version Supported BT5

Operation Frequency 2402MHz - 2480MHz

Modulation GFSK

Receiver sensitivity -96dBm

The wireless communication of the Withings ScanWatch NOAA is supported by a SLE communication. This communication is established between the Withings ScanWatch NOAA and the Withings App. The communication between the Withings ScanWatch NOAA and the Withings App is encrypted through an exchange of a paired key.

The communication latency between the Withings ScanWatch NOVA and the Withings App is prior to 10 seconds. A maximum operating distance of 6 meters allows a latency inferior to 10 seconds. The communication security is implemented by default (encrypted communication). The Withings App shall be downloaded from official stores (App store and Google Play store) and smartphones shall be up to date. Versions supported by the Withings App are iOS 15 or later or Android 9 or later. In case of communication failure, you should follow the related troubleshooting Measurements are stored within the Withings ScanWatch NOVA.

The communication between the Withings ScanWatch NOVA and the Withings App is not modified with sources of interference signals located within 5 meters.

This wireless coexistence has been tested in accordance with the following standards:

ANSI 06327 2021 and AAMF 1908/2017 (JG2020) Electromagnetic diaturbanous have been tested in accordance with the standard IEC 60601-1-22014/A12020

Cleaning & disposal

Cleaning of Withings ScanWatch NOVA

- Use a tint-free cloth moistened with warm water to clean the glass and casing of your Withings ScanWatch NOVA

- Run the wristband under warm water and rub it with hypoallergenic soap to clean it

Dry the white cloth with a soft blue

Notes:

- Avoid exposure to any chemical products such as solvents, detergents, perfumes, or cosmetics. They may damage the wristband or the casing of the watch.

- If the side button of your Willings ScanWatch NOVA appears to be stuck, we advise you to rinse the casing of your watch with warm water and dry it using a lint-free cloth.

- If the altmeter opening of Withings ScanWatch NOVA becomes dirty or clogged with debris or sweat, it can prevent the watch from

The watch should also be cleaned anytime that you work out with it on

- Withings does not recommend using an ultrasonic cleaner for Withings ScanWatch NOVA.

Avoid application of the Writings Scan-Watch NC/VA on a wrist with poor skin integrity. In case of skin irritation, we advise you to contact a dermatologist before resuming use of your device.

Skin reactions may be caused by:

- An allergic reaction to the materials used in the back casing of the watch.

Note that this device is compliant to IEC 6247: related to the photobiological safety of lamps and lamp systems.

European Union - Declaration of conformity

53 Withings hereby declares that the Withings ScanWatch Nova and Withings ScanWatch 2 companion eco are in conformity with the general safety and performance requirements of the Medical Devices Regulation (EU) 2017/743. The full text of the EU declaration of conformity can be found at: withings.com/compliance

CE 1282

Safety & performance

Performance and intended clinical benefit

The Withings ScanWatch NOVA 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 ScanWatch NOVA's ability to accurately classify an ECG recording into Atrial Fibrillation (AF) and Sinus Rhythm (SR) categories was tested in a clinical study including 626 patients. Rhythm classification by Withings ScanWatch NOVA was construed to the review by: camiologists of simultaneously recorded 12 lead ECG, 89.1% or recordings were conclusive (the neither "inconclusive" nor "poor recording") and with a heart rate between 50 and 150 bpm). On conclusive recordings, the sensitivity in classifying Atrial Fibrillation was 99.7% (lower bound of the 95% confidence interval: 98.1%) and the specificity in detecting normal sinus rhythm was 99.8% (lower bound of the 95% confidence interval: 99.1%). In addition, ScanWatch NOVA accurately classifies AF and SR into subgroup by heart rate < or > 100 bpm.

The mean difference between the algorithm calculated heart rate from Withings ScanWatch NOVA's strips (median over 30 seconds) and the heart rate measured by cardiologists on the 12-lead ECGs was -0.97 bpm (standard deviation: 3.5 bpm).

The quality of the ECG waveforms was assessed by the visibility and polarity of the P, QRS and T waves. The accuracy of the 6 endpoints ranged between 97.8% and 100%. In addition, the mean difference (standard deviation) for PR, QRS, and QT intervals was 3.4 (17.2) ms, -10.5 (15.9) ms, and 5.3 (23.6) ms respectively. Cardiologists also reviewed all the ECG strips generated via the Willings ScmWatch 2 comoscopy app. They found that 92.6% of the recordings were conclusive, and reached a sensitivity of 100% and a specificity of 97.9%.

The performance of the EOG function passed the applicable requirements on EOG 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.

The ability of Withings ScanWatch NOVA to accurately classify a PPC recording into Atrial Fibrillation and Sinus Rhythm categories was assessed through a clinical study including 166 patients. Rhythm classification was compared to the review of simultaneously recorded 12-lead ECGs by trained cardiologists. On classifiable signals (i.e., neither "noisy" nor "other arrhythmia"), the positive predictive value for AF detection was 0.864.

RF statement

Medical electrical equipment needs special precautions regarding Electromagnetic Compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in the accompanying documents. Portable and mobile RF communications equipment can affect medical electrical equipment.

Safety and performance

Guidance and manufacturer's declaration - electromagnetic emissions

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such an environment.
Emissions test	Compliance	Electromagnetic environment – guidance
CK emissions CISFRII	Group 1	The device 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
RC emissions CISFRII	Class D
Harmonic emissions IEC 61000-3-2Voltage fluctuations/Flicker emissions IEC 61000-3-2	Not applicableNot applicable	The device 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

Declaration - electromagnetic immunity

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

Withings ScanWatch NOVA is intended for use in the electromagnetic environment specified below. The customer or the user of the Withings ScanWatch NOVA should ensure that it is used in such an environment

Immunity test (FC 6080) Test Level Compliance Level Electromagnetic environment - guidance

Conducted RF	3 Vrms	3 Vrms	The FUT shall be placed on an insulating support 0.1 m above the ground reference plane (GRP). On all cables to be tested, coupling and decoupling devices shall be inserted. The coupling and decoupling devices shall be placed on the GRP, making direct contact with it at a distance of 0.1 m to 0.3 m from the EUT.
IEC 61000-4-6	150kHz to 80MHz	150kHz to 80MHz
Radiated RF	10 V/m	10 V/m	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.
IEC 61000 4-3	80 MHz to 2.7 GHz	80 MHz to 2.7 GHz

Electrostatic discharge (ESD) Contact: 28 kV Contact: 28 kV Floors should be wood, concrete, or ceramic tile. If floors are Air: 12 kV, 34 kV, 5 kV; Air: 12 kV, 34 kV, 5 kV, covered with synthetic material the relative humidity should be 115 kV 115 kV at least 30%. IEC 61000-4-2

Electrical fast trans- 2 kV for power supply N/A the main power quality should be of the kind used in a typical sient/burst lines commercial or hospital environment.

IEC 61000-4-4	1 kV for input/output lines
Surge IEC 61000-4-5	1 kW differential mode2 xV common mode	line(s) to line(s): +/-1kVThe main power quality should be of the kind used in a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply-input lines IEC 61000-4-11	Voltage dips: 0% residual for 0.3 cyclesVoltage dips: 0% residual for 1 cycleVoltage dips: 70% residual for 25 cyclesVoltage interruptions: 0% residual for 250 cycles	NA The main power quality should be of the kind used in a typical commercial or hospital environment. If the user of the equipment or system requires continued operation during power main interruptions, it is recommended that the equipment or system be powered from an uninterruptible power supply or a battery.
Power frequency (50/50Hz) magnetic field IEC 61000-4-8	50 A/m50 Hz or 60 Hz	50 A/m50 Hz or 60 HzThe power frequency magnetic field should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Federal Communication Commission interference statement

This device complies with part 15 of the FOC 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.

FCC Cautions: Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 18 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, it 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

IMPORTANT NOTE:

Radiation Exposure Statement

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with a minimum distance of 20 cm between the radiator & your body. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. Country Code selection feature to be disabled for products marketed to the US/CANADA.

Disposal

Actuation of European directive 2012/19/EU, for reduction in use of dangerous substances in electric/electronic devices and in 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 a collection center for electric/electronic garbage, or return it to the retailer when purchasing a new device. Disposing of the product separately prevents possible negative environmental and health consequences related to inadequate disposal. It also allows for the recovery of materials to save energy and resources as well as to avoid negative effects on the environment. In case of incorrect disposal of devices by the user administrative enforcements will be applied to compliance with current standards. The device and its parts must be disposed of as deemed appropriate. In accordance with national or regional regulations. For regulatory information about ScanWatch Note, go to Devices > Additional Regulatory Information

Warranty

Withings™ Two (2) Years Limited Warranty - Withings ScanWatch NOVA

Withings: 2 rue Maurice Hartmann, 92350 Issy-lee-Moulineaux. FRANCE ("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 or TWO (2) YEAR5 from the date of original retail purchase by the end-user purchaser ("Warranty Period"). Withings' published guidelines include out are not limited to information contained in technical specifications, safety instructions or the quick start guide. Withings does not warrant that the operation at 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.

All Our goods come with guarantee 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.

? Need help ?

https://support.withings.com/

Security

Withings recommends that you add a passcode (personal identification number [PINF], 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 should follow the password and two-factor authentication guidelines when logging into Withings Auto. For more information on password requirements refer to https://support.Withings.com/hc/articles/3500272737. For more information on two-factor authentication refer to https://support.withings.com/hc/en/services/41093459/36597 for iOS users and refer to https://support.withings.com/hc/en/articles/286038583633 for Access Users. Users will receive email alerts for case numbers related to password, two-factor authentication and recovery code. Users also include ID data from https://www.withings.com/ and http://www.withingsApp and updates are delivered, wirelessly encouraging rapid adoption of the latest security fees. Users are able to see the currently installed firmware in the Withings App, under Devices > ScanWatch NOVA. This tab also indicates if an update is available.

Do not install the devices 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. Use a secure channel when you are sharing ECG information with your doctor. Withings also recommends upgrading your Withings App when an upgrade is available. The Withings App is not intended to be used on a computer. No anti-virus software is needed. Only use official app stores to download the Withings application. In case of doubt, use the link go(withings.com.

If needed, users can restore device configurations by following the factory reset procedure. For more information refer to https://support.withings.com/hc/en-us/articles/360010218558

Equipment Symbol Description

Direct current

Model Number

Catalog number

Do not use if package is damaged and except

10.2024年10月

23

Type BF apole part (back case)

Regulatory Comparison More (H2A) with ADMA is-

Eating requirements

② Use of PAPERS, the use of 50-watt electronic instructions for use.

Medical devices (Non-UE users)

① Follow instructions for use

1

KAI HUAJIEN: A 4.50M (11:30, 12:30)

1. Compacts with waste electrical and electronic equipment

-

CE Complex with the general variety and performance

1202 Management of the Medical Devices Corporation (USA) 2007/345

CancBoard

State Authorized Representative

1. Upside the importer in Switzerland

图 50

[1] D#P device identifier

Temperature limit

• (improbiotic stress no bidirectional

35

1. Monthly limitation

2. Protected against said foreign objects of 2.5 mm

3.5.1.4.2017

When ENCLOSURE Bled up in 15°

No changing device included with the media equip

mark (Effective 2014/53/EU)

Australian Sponsor

Emergo Australia, Level 20, Tower II

Lating Park, 25-2629-Street-8751, NSW 2003

不适用

UK Responsible Person

Ersego Consulting UK Limited c/o €380

CL Pharma 2013

Compass House, Vitch Park Nelson Cronbach's CTM 967

United Kingdom

CH REP: Me Povoy Ked (s)

6302.80

Figure

GUIDE D'UTILISATION

FR - RÉGIONS NON AMÉRICAINES

The Withings ScanWatch NOVA is to be used with a software accessory, the Withings ScanWatch 2 companion app. It allows the installation of the watch, activates its medical features, and displays the results of performed measurements. It is part of the Withings App.

Pour commencer

Contenu de la boite

Line drawing of two hands holding wristwatches (no text or symbols)

Sorties ECG

Classification ECG

- Fibrillation subcuta: (frequency cardiacula comprise entire 50 at 49 rpm),

(Fraction cardiac) - Frequency cardiac (*réquence cardiac entre 102 at 150 bpm)

- Non concluant

- Enregistrement médiocre

Guidance and manufacturer's declaration - electromagnetic emissions

- It is a key solution of the solution

1. 本次发行的种类和面值

(1) MOUNT OF THIS ON THE HEALTH

ENIXIMEREMENT (more seque 15)

percent radio (directive 2014/53/UE)

Фактиз на кінки

Emergo Australia, niveau 20, tour I

Parc Darling, 201 Buscox Street

Sydney, NSW 2000

Acquisitions

Emergo Consulting (UK) Limited c/o CrS60

UL International

Compass House, Vision Park Helen

Cambridge CB01 REZ

Royalty-UN

United Kingdom

CH REP

2019.05

图 1-3

BENUTZER-HANDBUCH

Energy investments with Switzerland as an analyst's financial advisor Daim Jones Pte. Milliamas Fosca/Drak MOTA MOPF, whose as research director is: One International and other investment banking companies have at Uebel insurance rates

Dr. Kattam, 19th St. Chetral GPs: Taiti Sui 20 (2017), Varrada (Amplarado)

-10 C (-) = C (dis) / dis then so C (+) = 5 L)

The following section of the Tail class (with some Automatic use

Um zu beginnen

Line drawing of two hands holding wristwatches with wristband (no text or symbols)

EKG-Ausgänge

EKG-Klassifizierung

■ 1. Christian's name in the Great

ENTERPRISE survey has at 15

Emerse Australia, Sturfa 20, Funde I

Darling Park 201 Survey Street

Sydney, NSW 2000

A. reuters

Emeren Consulting UK Limited c/o Cr860

U. International

Cerpass House, Vision Park Helcr

Cambridge CEMI REZ

AW_PRODUCT GUIDE HWA10 MODEL-10-11_INT_B

WITHINGS

Withings ScanWatch Nova © 2025 Withings. All rights reserved. V1.0 March 2025

support.withings.com - 2 rue Maurice Hartmann, 92130 Issy-les-Moulineaux, FRANCE