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Related Manuals for Withings ScanWatch 2
Summary of Contents for Withings ScanWatch 2
- Page 1 Wit hing s Sc an Watc h 2 w it h S c a n M on i tor ScanWatch 2 Information Guide (also referred to as Regulatory Leaflet) Disclaimer: Information in this guide may change without notice. Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.
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Page 2: Product Guide
The Scan Monitor is intended for spot-checking of adult patients in hospitals, clinics, long-term care facilities, and homes. This brochure explains how to use the Scan Monitor functionalities on your ScanWatch 2. WITHINGS, 2 rue Maurice Hartmann, 92130 Issy-les-Moulineaux, FRANCE +33141460460... - Page 3 Contraindications Warnings Scan Monitor is not intended to continuously monitor vital Before using the equipment, be sure to read this signs in critical conditions or where the nature of the variations equipment manual carefully. is such that it could result in immediate danger to the patient. Regardless of the measurements taken using this Scan Monitor does not provide alarms.
- Page 4 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 2 if it is damaged. Use of a damaged device could cause patient injury or equipment failure.
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Page 5: Important Notes
Important notes The Scan Monitor one output: ECG for Atrial Fibrillation The device conforms to IP22 requirements. The Scan Monitor is intended for use in adults (22 years or older in the U.S.) and with no restrictions on weight. The screen of the watch will display the percentage of charge when it is plugged. Use a power cord that matches the voltage of the power outlet, which has been approved and complies with the safety standard of your particular country. - Page 6 - Before being able to use the Scan Monitor, you have to download the Withings app in order to activate it - Scan Monitor is only available for Withings ScanWatch 2 when it is paired with a smartphone with iOS 15 or later or Android 9 or later - Use a trusted Wi-Fi network with your companion app.
- Page 7 How to take an ECG recording: - ECG, or electrocardiogram, is the graphical rep- - Make sure your ScanWatch 2 is snug on the wrist that resentation of the electrical activity of the heart. It can you selected in the companion app to be your measure- detect certain cardiovascular pathologies.
- Page 8 - 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 Withings app. - If the feature has been activated, the measurement starts, otherwise the screen displays an invitation to activate the feature.
- Page 9 - If you receive an inconclusive result due to a poor recording, you might try to re-record your ECG. You canreview how to take an ECG during setup or by tapping Take a Recording in the ECG section of the Withings app on your smartphone.
- Page 10 - The distinction between the four inconclusive classification types can be found in the Withings app, as described below. - The classification of the ECG recording is for informational use only. It is meant to supplement, but not replace, traditional diagnosis methods.
- Page 11 ECG classification Possible outputs in the Withings app: Fig. 3.2 Fig. 3.1 Signs of Atrial Normal Sinus Rhythm Fig. 3.3 Fig. 3.4 Fibrillation Inconclusive Noise...
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Page 12: Technical Specifications
Battery Operated: 30 days typical use on a single charge Power Source: 3.87 Vdc Lithium ion battery (Use the charging cable and Withings ScanWatch 2 watch charger ASM-13639 5 VDC 500mA) (included) and a DC 5V power adapter that was certificated by IEC 60601-1. -
Page 13: Wireless Information
(encrypted Version Supported BT5.1 communication). The Withings app shall be downloaded from official stores (App Operation Frequency 2402MHz- 2480MHz store and Google Play store) and smartphones shall be up to date. Versions supported by the companion app and the Scan Transmission power -0.65 (max) -
Page 14: Safety And Performance
*IEC 60601-2-47:2012: Requirements for the Basic Safety and Essential Performance of Ambulatory Electrocardio- graphic Systems. Regarding safety, the ScanWatch 2 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... - Page 15 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.
- Page 16 Safety and Performance 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. Immunity test IEC 60601 Test Level Compliance Level Electromagnetic environment –...
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Page 17: Federal Communication Commission Interference Statement
(1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Accessing the FCCID E-Label: Open the Withings app, go to “Devices” > Select your ScanWatch 2 > See more IMPORTANT NOTE: Radiation Exposure Statement: This equipment complies with FCC radiation exposure limits set forth for an uncon- trolled environment. - Page 18 I’m having syncing issues with my watch. Solutions: - Make sure that your ScanWatch 2 appears in Devices in the Withings App, if not, you need to install it - Select Device in the Withings app and make sure that your ScanWatch 2 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 2.
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Page 19: Cleaning And Disposal
Solutions: - 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. -
Page 20: Equipment Symbols
Equipment symbols AW_P Manufacturer Type BF-Applied Part (case) Temperature limit IP22 Ingress of water or particulate matter Atmospheric pressure limitation Complies with waste electrical and electronic equipment directive Humidity limitation California Energy Commision approval Serial number Federal Communications Commission Consult instructions for use RxOnly Federal law (USA) restricts this device to sale by or on the order of a licensed... - Page 21 AW_PRODUCT_GUIDE_US_RX_HWA10_A ScanWatch 2 with Scan Monitor | Proactive Health Tracking © 2023 Withings. All rights reserved. V1.0 June 2023 support.withings.com - 2 rue Maurice Hartmann, 92130 Issy-les-Moulineaux...