SCANWATCH QUICK INSTALLATION GUIDE GUIDE D'INSTALLATION I GUfA DE INSTALACION I GUIDA ALL' INSTALLAZIONE I NSTALLATIONSAN LEITUNG EN I FR I ES I IT I DE I
THANK YOU FOR CHOOSING WITHINGS SCANWATCH MERCI D'AVOIR CHOISI WITHINGS SCANWATCH GRAZIE PER AVER SCELTO WITHINGS SCANWATCH J J GRACIAS POR ELIGIR WITHINGS SCANWATCH DANKE, DASS SIE WITHINGS SCANWATCH GEWAHLT HASEN This guide is available in additional languages at: www.withings.
Contents of the transport pouch Contenu de la pochette I Contenido de la bolsa de transporte Contenuto della custodia da trasporto I I lnhalt des Transport-Etuis 0 ECG ~O WI SCAN WATCH Charging cable Cable de chargement I Cable de carga Cavo di ricarica I Ladekabel
Quick start Demarrage rapide I lnicio rapido I Avvio rapido I Schnellstart 4-5 Visit go.withings.com to get the app and follow the instructions. FR Obtenez l'appli sur go.withings.com et suivez les instructions. SCANWATCH ES Visita go.withings.com para conseguir la aplicaci6n y sigue las instrucciones. IT Visita go.withings.com per ottenere l'app e segui le istruzioni. DE Besuchen Sie go.withings.com und holen Sie sich die App und die Anweisungen.
Product installation Installation du produit I 1nstalaci6n del producto I lnstallazione del prodotto I Produkt-lnstallation Install your watch in the application and follow the guide to discover all the functionalities of your product. SCANWATCH FR lnstallez votre ScanWatch dans !'application et laissez vous guider pour decouvrir les fonctionnalites de votre produit. ES lnstala tu reloj en la aplicaci6n y sigue la gufa para descubrir todas las funciones del producto.
How to wear ScanWatch Comment porter ScanWatch I Como llevar ScanWatch I Come indossare ScanWatch I So tragen Sie ScanWatch? The wristband should be tight but comfortable, and worn 1 cm away from the wrist bone FR Le bracelet doit etre bien ajuste mais confortable, et se trouver a 1 cm de l'os du poignet. I I DE Das Armband sollte fest, aber bequem anliegen und 1 cm vom Handgelenkknochen entfernt getragen werden.
How to Charge ScanWatch Comment charger ScanWatch I Como cargar ScanWatch I Come caricare ScanWatch Wie lade ich ScanWatch auf? Recharge using the cable found inside the pouch. Battery life: up to 30 days + 20 more days in power reserve mode (time and activity tracking only). FR Recharge aisee avec le cable fourni dans la pochette. Autonomie: jusqu'a 30 jours + 20 jours en mode economie d'energie (heure et suivi d'activite uniquement). 1.
Overview Vue d'ensemble I Imagen general I Vista d'insieme I Gesamtubersicht QA Wristband QC Activity Dial FR Bracelet FR Cadran d'activite ES Pulsera IT Braccialetto DE Armband ES Cuantificador de actividad IT Quadrante attivita DE Aktivitatenanzeige A B B QDisplay @ Heart rate and Sp02 sensor FR Affichage FR Capteur de frequence cardiaque et de Sp02 C ES Pantalla IT Display DE Anzeige ES Frecuencia cardfaca y sensor Sp02 IT Frequenza cardiaca e sensore Sp02 DE Herzfrequenz und Sp02-Sensor D
Warranty Garantie I Garantia I Garanzia I Garantie US Withings Two (2) Years Limited Warranty - Withings ScanWatch Withings, 2 rue Maurice Hartmann, 92130 lssy-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»).
-11 ES Garantia comercial de limitada dos (2) Anos de Withings - Withings ScanWatch Withings, 2 rue Maurice Hartmann, 92130 lssy-les-Moulineaux ("Withings") garantiza el material de la marca Withings ("Producto Withings") contra los defectos de material y de mano de obra, siempre que se haya utilizado conforme a las recomendaciones publicadas sobre el Producto Withings y cuando los mismos aparezcan durante el periodo de DOS (2) ANOS a partir de la fecha de compra inicial del Producto Withings nuevo en un
Materials Materiaux I Materialien I Materiale I Materiale EN List of materials potentially in contact with the skin during usage: Fluoroelastomer, silicone, leather, sapphire glass, stainlesssteel, rose gold and titanium. FR Liste des matieres potentiellement en contact avec la peau durant !'utilisation : Fluoroelastomere, silicone, cuir, verre saphir, acier inoxydable, or rose et titane.
Information to users in Canada Information pour les utilisateurs au Canada EN 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 acceptany interference received, including interference that may cause undesired operation.
BC • Need help? Besoin d'aide? I Brauchen Sie Hilfe? LNecesitas ayuda? I Ti serve aiuto? I Precisa de ajuda? -+ withings.
QIG_HWA09_66 WITHINGS ScanWatch I Proactive Health Tracking © 2021 Withings. All rights reserved .
Withings ScanWatch wit h Scan Monitor Scan Watch Information Guide (also referred to as Regu latory Leaflet) Disclaimer· Information in this guide may change without notice. I\. Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.
This brochure explains how to use the Scan Monitor functionalities on your ScanWatch.
Indications for use (Intended for US region) 3 The Scan Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Scan Monitor also displays ECG rhythms and detects the presence of atrial fibrillation (when the monitor is prescribed or used under the care of a physician). The Scan Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals.
Contraindications & 4 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.
Warnings & 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. The 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.
Warnings & Factors that may degrade performance of reflectance pulse oximetry (measurement of oxygen saturation) include: - Bright sunlight - Presence of strong electromagnetic fields - Failure to apply the device correctly (loose wristband application, not on top of the wrist) - Tattoos on the wrist in the region of the optical sensor - Excessive motion of the arm, wrist, or fingers - Low b lood perf usion caused by room temperature below the recommended operation range, or by certain conditions such as
Warnings & 7 Misapplication of the ScanWatch with excessive pressure and for a prolonged period can cause injury. Avoid using the ScanWatch on a wrist with poor skin integrity. DO NOT sterilize using 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.
Warnings & No modification of this equipment is allowed. DO NOT modify this equipment without authorization of the manufacturer. The Power cord of the charger may cause strangulation effect due to excessive length, keep it away from children and pets. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment. The battery inside the watch will stop charging when the temperature is less than -10°C (+/-5°C) or over 50°C (+/-5°C).
Important Notes The Scan Monitor measures two separate outputs: (1) ECG for Atrial Fibrillation; and (2) Pulse Oximetry for Oxygen Saturation (Sp02). The measurement of SpO2 in the 70-100% range has been clinically validated on healthy adult volunteers, at rest, against a laboratory co-oximeter. The device conforms to IP22 requirements. This device has no alarm system in case of low saturation. The Scan Monitor is intended for use in adults (22 years or older in the U.S.) and with no restrictions on weight.
Important Notes The expected service life for Scan Monitor is 2 years. When in need of assistance on using, maintaining or to report unexpected event please contact manufacturer for further information (please see the last page of this leaflet). No service or repairs should be performed on the Scan Monitor hardware other than the maintenance listed in this leaflet. Inspect sensors for warping, surface damage or corrosion and check for any other form of damage.
Using the Scan Monitor 11 Before you start: - Before being able to use the Scan Monitor, you have to download the companion app Health Mate in order to activate it - Scan Monitor is only available for Withings ScanWatch when it is paired with a smartphone with iOS 12 or later or Android 8 or later - Use a trusted Wi-Fi network with your companion app.
Using the Scan Monitor 12 Setup: - Open the Withings Health Mate app after having downloaded it on stores (App store and Google Play store) - In the Devices tab, select "Install a device", then select "Watches" - Select the product "ScanWatch" - Follow the on-screen instructions. You will be prompted to pair your device via Bluetooth.
What is an ECG? 13 How ScanWatch obtains an ECG: - ECG, or electrocardiogram, is the graphical representation of the electrical activity of the heart. It can detect certain cardiovascular pathologies. - 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. This 12-lead ECG records electrical signals from different angles in the heart to produce twelve different waveforms.
Taking an ECG How to take an ECG recording: - Make sure your ScanWatch is snug on the wrist that you selected in the companion app to be your measurement wrist. You can modify your measurement wrist in the companion app, in Devices > ScanWatch > More Settings > Device Orientation. - Rest your arms on a table, and hold the top electrode with your other hand (as shown in Fig. 1). You do not need to press the bezel during the session. Fig.
Taking an ECG 15 How to take an ECG recording: - Activate the ECG measure using the watch interface: press the button, then search for the ECG menu screen on the watch. Launch the measurement by pressing the button one more time. You cannot start an ECG from the Health Mate companion app. - If the feature has been activated, the measurement starts, otherwise the screen displays an invitation to activate the feature. - The recording starts after the first vibration. - The recording lasts for 30 seconds.
ECG Outputs 16 ECG classification: After an ECG recording, you will be able to see one of the following classifications for the recording: - Normal Sinus Rhythm: A sinus rhythm means your heart is beating in a uniform pattern. - Atrial Fibrillation: Atrial Fibrillation occurs when the two upper chambers of the heart move randomly instead of pumping regularly. This does not allow for complete emptying of the chambers and thus, blood may become stagnant and create blood clots.
ECG Outputs 17 ECG classification: - A result of Normal Sinus Rhythm means your heart rate is between 50 and 100 beats per minute (bpm) and is beating in a regular pattern.
ECG Outputs 18 Possible outputs on the device screen: 0 0 Atria Fibr illction lncondusive Fig. 2.7 Fig. 2.2 Fig. 2.3 Fig. 2.4 Normal result on the device Atrial fibrillation result on the device Inconclusive result on the device Median heart rate - The distinction between the four inconclusive classification types can be found in the Health Mate companion app, as described below. - The classification of the ECG recording is for informational use only.
ECG Outputs 19 Possible outputs in the Health Mate companion app: . . .. 9.41 < 18 ICO r- " ' - A.,g20 < I CO Mon,Aug20 • ,..... • I> .. • .. . 9·41 ... IQo Nounal s,rw.,s Rhythm I> .. "' e S,gns ol A·F•b 62bpm HNrt Rare HNrt Rate fttw..._t'°"' n.., ECG dONn t show l1oM ot atrial It )'Oi.l ~ yo..,·,w ~'"9 I hert •tt.o ~~ Of I fi&ftion (;.c In tOUC/1 With V'OUJ' 00<.COt Fig. 3.1 Fig. 3.
ECG Outputs 20 Possible outputs in the Health Mate companion app: .. , . . .. 941 < < ICO II • I> .. ., I> .. .,. _____ ,c;o_ .. M 11\ConcluliW ....... metl\l ll'\M h diifttce ~SiiNnRt,vtrvn AlllAl'F'--.bonot kiOtlie. ,,.,.cCkM.~rN'IOMNfltk• One ,-...on II u,- ~ ol irlt•f.,..nt• M 10 ~ H of tN ar'9\ Wmt OI' f&nVe'I ~ U11 l#l"c,ly N 1h11 the hHr1 ,... • •
Sharing ECG Results How to share your ECG with your physician: Once the feature is unlocked, the results of the ECG can be shared with a physician as a pdf, Health Mate companion app. generated by the Health Mate companion app.
What is an Sp02 Measurement? 22 How ScanWatch obtains an Sp02 measurement: - Sp02 stands for peripheral capillary oxygen saturation, an estimate of the amount of oxygen in the blood. More specifically, it is the percentage of oxygenated hemoglobin (hemoglobin containing oxygen) compared to the total amount of hemoglobin in the blood (oxygenated and non-oxygenated hemoglobin). - Hemoglobin is a protein that carries oxygen in the blood to your organs.
Taking an Sp02 Measurement 23 How to take an Sp02 measurement: - Tighten the band so that the back of the watch is in contact with the skin of your wrist. - Rest your arm on a table, with the hand relaxed and in an open position. - Hold the watch with your other hand (as shown in Fig. 1). You do not need to press on the watch during the session. - Activate the Sp02 measure using the watch interface: press the button, then search for the Sp02 menu screen on the watch.
Taking an Sp02 Measurement How to take an Sp02 measurement: Fig.
Sp02 Outputs 25 Possible outputs on the device screen: 0 lncondusive Fig. 5.1 Fig. 5.2 Fig. 5.3 Normal result on the device Low result on the device Inconclusive result on the device - The Scan Monitor is validated for the range 70% to 100%. It is displayed on a gauge from 85% to 100%. Results between 70% and 85% are simply indicated as below 85% by the cursor on the gauge, as shown on Figure 6.
Sp02 Outputs 26 Possible outputs in the Health Mate companion app: ..... < OXYOI .. IAtU - A1t0N < O X¥0 1N 1- y. 8•2 ..... .. < IA TU ■ A TIO N Toddy, 80 - - - .- 0 • - S.~et,on (o, Su02) •tlle
Sp02 Outputs 27 Note: The following table for evaluating your measurements does not apply to people with certain pre-existing conditions (e.g. asthma, heart failure, or respiratory diseases) or those who are at altitudes above 1500 meters. If you have a pre-existing condition, always consult your doctor to evaluate your measurements.
Sp02 Measurement Information 28 Note: The following table informs you of the effects of various altitudes on oxygen saturation value and its impact on the human body. It does not apply to people with certain pre-existing conditions (e.g., asthma, heart fai lure, respiratory diseases). People with pre-existing conditions may show signs of illness, such as hypoxia, at lower altitudes.
Technical specifications Product Name Scan Monitor Model HWA09 ECG Sensor 3 stainless steel electrodes SpO2 Sensor Green wavelength: 530 nm (522-542 nm) Red wavelength: 655 nm (652-658 nm) Infrared (IR) wavelength: 940 nm (930-950 nm) Maximum Optical Power Green: 0.56 mW Red: 0.52 mW IR: 0.
Wireless information 30 Wireless Specifications: Wireless Technology Bluetooth BLE Version Supported BTS.l Operation Frequency 2402MHz- 2480MHz Transmission power +8dBm (max) Modulation GFSK Receiver sensitivity -96d Bm The wireless communication of the Scan Monitor is supported by a BLE communication. This communication is established between the Scan Monitor and the Health Mate Companion App.
Wireless information 31 A maximum operating distance of 5 meters allow to have a latency inferior to 10 seconds. The communication security is implemented by default (encrypted communication). The Health Mate companion app shall be downloaded from official stores (App store and Google Play store) and smartphones shall be up to date. Versions supported by the companion app and the Scan Monitor are iOS 12 or later or Android 8 or later.
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.
Safety and Performance 33 Scan Monitor software's ability to accurately classify an ECG recording into Atrial Fibrillation and normal sinus rhythm categories was tested according to the IEC 60601-2-47* standard and a clinical study with 262 subjects. On five public databases, the Scan Monitor demonstrated 99.06% sensitivity in classifying Atrial Fibrillation and 98.66% specificity in classifying normal sinus rhythm in classifiable recordings.
Safety and Performance 34 Regarding safety, the ScanWatch has been tested and deemed in compliance according to IEC 60601-1 and its applicable collateral standards (IEC 60601-1-2:2014, IEC 60601-1-11:2015). This device is in compliance with ISO 10993-1:2009. The safety and performance of the pu lse oximetry feature has been tested against IEC 80601-2-61:2017.
Safety and Performance RF Statement: Guidance and manufacturer's declaration-electromagnetic emissions Scan Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Scan Monitor should ensure that it is used In such an environment. Compliance Emissions test Electromagnetic environment-guidance CE emissions CISPRll Group 1 RE emissions CISPR11 Scan Monitor uses RF energy only for its internal function.
Safety and Performance 36 Declaration: Electromagnetic emissions and immunity for equipment and systems that are not life-supporting and are specified for use only in a shielded location. Declaration: Electromagnetic immunity Scan Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Scan Monitor should ensure that it is used in such an environment.
Safety and Performance 37 Immunity test IEC 60601 Test Level Compliance level Electromagnetic environment-guidance Electrical fast transient/ burst IEC 61000-4-4 2 kV for power supply lines 1 kV for input/output lines N/A The main power quality should be of the kind used in a typical commercial or hospital environment. Surge IEC 61000-4-5 1 kV differential mode 2 kV common mode N/A The main power quality should be of the kind used in a typical commercial or hospital environment.
Troubleshooting - Syncing with App I'm having syncing issues with my watch. Solutions: - Make sure that your ScanWatch appears in Devices in the Health Mate App, if not, you need to install it - Select Device in the Health Mate app and make sure that your ScanWatch is connected - If necessary, try to turn on the Airplane mode on your mobile device and then turn it back off - If necessary, reboot your ScanWatch.
Troubleshooting - ECG 39 If you experience d ifficulties in operating your Scan Monitor, refer to the troubleshoot ing guide below. I cannot get the Scan Monitor to take an ECG reading. Solutions: - Make sure your wrist and your ScanWatch are clean and d ry.
Troubleshooting - ECG The ECG waveforms appear upside down. Solutions: - 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.
Troubleshooting - Sp02 ScanWatch indicates that I am not staying still during Sp02 measurements.
Troubleshooting - Sp02 42 have an inconclusive Sp02 measurement. Solutions: I - Ensure that you have completed all of the setup 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 t o increase skin perfusion - Make sure that your ScanWatch is not loose on your wrist.
Cleaning and Disposal Cleaning the ScanWatch: - When needed, use a lint-free cloth moistened with warm water to clean the top housing and casing of your ScanWatch - Run the wristband under warm water and rub it with hypoallergenic soap to clean it - Dry the wristband with a soft cloth Disposal: ScanWatch is classified as electrica l and electronic equipment.
Equipment symbols Symbol Description Manufacturer SN 44 Serial number (]] RxOnly Temperature limit Humidity limitation Atmospheric pressure limitation Consult instructions for use IP22 Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner :a- Follow instructions for use [!] Type BF applied part No Sp02 Alarm Ingress of water or particulate matter Complies with waste electrical and electronic equipment directive
REG_HWA09_86 WITHINGS ScanWatch I Proactive Health Tracking © 2021 Withings. All rights reserved. support.withings.com - 2 rue Maurice Hartmann, 92130 lssy-les-Moulineaux - v2.
