Body Scan - Scale WITHINGS - Free user manual and instructions

USER MANUAL Body Scan WITHINGS

This guide explains how to use your Withings Body Scan, and gives additional regulatory information on how to use the Withings ECG Monitor on your Withings Body Scan.

Important notice

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

For more information on how to use the Withings ECG Monitor with your Withings Body Scan, please refer to the Withings ECG Monitor Instructions for Use, available at: https://www.withings.com/guides

Retain this documentation for future reference. Installation instructions are available within the Quick Start Guide provided with this user guide. 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 Body Scan should be reported to Withings and competent authorities in your country of residence.

Disclaimer

Information in this guide may change without notice.

WITHINGS.

Intended Use (Non-US Regions)

Withings Body Scan is a connected smart scale providing the following features without medical purposes:

• measure weight
• calculate Body Mass Index (BMI)
• measure body composition
• measure pulse rate
• measure pulse wave velocity
• estimate vascular age

Additionally, Withings Body Scan is intended to detect and follow-up peripheral autonomic neuropathies in an adult population by performing measurements on the feet, on intact skin or in the presence of damaged skin, such as, but not limited to, blisters, callosities or wounds.

Withings Body Scan comprises electrodes intended to acquire an ECG signal used by Withings ECG Monitor.

Contraindications

Do not use the Withings Body Scan if you have a cardiac pacemaker, an implantable cardioverter-defibrillator (ICD), or other implanted electronic devices.

Warnings & safety notice

• Self-diagnosis and self-treatment can be dangerous.
  Always consult your doctor in case of questions or doubt.
• If you are pregnant, accuracy may be impacted for body composition analysis, Nerve Health Score, vascular age and ECG. Consult your doctor during pregnancy.
• The use of medication with anticholinergic agents may impact Nerve Health Score results. Ask your doctor about the medications you take if you are not sure whether they have anticholinergic properties.
• Drinking alcohol 24 hours prior to taking a measurement may affect the results of the Nerve Health Score.
• Misuse of the device can cause injury.
• Measurement results may be impacted in case of lower limb amputation bigger than toes.
• Do not step on the scale with wet feet or hands.
• The device 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 user.
• The device does not provide alarms.
• Keep away from children and pets. Small parts may be inhaled or swallowed.
• Exposing the device to prolonged lint, dust or light (including sunlight) may reduce its lifetime or damage it.
• Inspect electrodes for warping, surface damage or corrosion and check for any other form of damage.
• Do not use Withings Body Scan if it is damaged. Use of a damaged device could cause injury or equipment failure.
• Do not submerge the scale or any of the components in water.
• Do not try to repair or modify this equipment yourself. No service or repairs should be performed on the Withings Body Scan other than the maintenance listed in the device's instructions for use.
• Do not use accessories, detachable parts, or materials not described in the instructions for use. 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.

• 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, degradation of the performance of this equipment could result.
• 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.
• Do not interconnect this equipment with other equipment not described in the instructions for use.
• Follow operational and storage conditions as described in the technical specifications section of the device's instructions for use. Otherwise, measurement results may be impacted.
• To recharge the battery, use a power cord that complies with the safety standards of the country in which it is used and that matches the voltage of the power outlet.
• The power cord of the charger and the handle cable may cause a strangulation effect due to excessive length. Keep it away from children and pets.
• Do not open or disassemble the device for battery replacement.

How to use Withings Body Scan and take a first measurement

• Follow the information in the Quick Start Guide and in the Withings application to set-up your device.
• To wake up your device for the first time, please press the power button for 3 seconds. If your product is not starting, consider charging it for a minimum of three hours and try again.
• 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 application in order to activate some measurements. Withings ECG Monitor requires you to follow a tutorial for the activation of the metric.
• To take the first measurement, grab the handle (optional) and step on the scale with bare feet. Your name, or trigram (as configured in the app), will appear on the scale's screen at the end of the weight measurement: it means your scale has correctly identified you and the measurements sequence (as defined in the app) will follow.
• If it is not the case, the measurement will most likely appear in "Unknown Measurements" in the application. Please assign it to your user so that the scale can automatically recognize the user during the next weigh-in.

What is a Nerve Health Score?

How Withings Body Scan obtains a Nerve Health Score

• The Nerve Health Score is based on a Galvanic Skin Response measurement which consists of a chronoamperometric measurement of the feet. It provides an accurate evaluation of sweat gland function, also called sudomotor function.
• Withings Body Scan measures the ability of the sweat glands to release chloride ions in response to an electrical stimulus on the soles of the feet, the area with the highest sweat gland density.
• The measurement focuses on small nerve fibers that stimulate the sweat glands. The degeneration of these small nerve fibers reduces sweat gland stimulation and impairs the sudomotor function.

Taking a Nerve Health Score Measurement

How to obtain a Nerve Health Score

• Make sure the Withings Body Scan is on a stable floor, and that you have activated and enabled a Nerve Health Score measurement in the Withings application.
• Optional: grab the handle. Please note that the measurement does not require holding the handle. A Nerve Health Score measurement can be performed even if the handle is in its storage position.
• Step on the scale with bare feet. Make sure your feet are clean and well positioned on the electrodes. See images below to ensure your feet are well positioned.
• Withings Body Scan will deliver a final Nerve Health Score reading at the end of each month. The reading might be inconclusive if we were not able to accurately assess your score. We might invite you to take a Guided Scan measurement in specific conditions in order to get a result. To get the most accurate measurements always take the Nerve Health Score measurements in the conditions described in the Guided Scan.

Three-step illustration showing foot positions in a container with checkmarks indicating completion or confirmation.

Nerve Health Score Outputs

Signs of Neuropathy

Your Nerve Health Score is lower than average. This may be a sign of peripheral neuropathy, or damage to the nerves in your feet. To better understand if you are at risk for peripheral neuropathy, talk with a healthcare professional. Always consult with your doctor before making any medical decisions. You can help keep your nerves healthy by taking care of your overall health. This includes healthy eating, getting regular physical activity, and working with your doctor to manage any health issues that you may have.

Normal

Your Nerve Health Score is normal. You can help keep your nerves healthy by taking care of your overall health. This includes healthy eating, getting regular physical activity, and working with your doctor to manage any health issues that you may have.

Pending

The reading might be inconclusive or in progress if we are not able to accurately assess your score. We might invite you to take a Guided Scan measurement in specific conditions in order to get a result. To get the most accurate measurements always take the Nerve Health Score measurements in the conditions described in the Guided Scan.

Results on the device

NERVE HEALTH 45 LOW

Results on the device

NERVE HEALTH 82 NORMAL

Results on the device

NERVE HEALTH PENDING

Troubleshooting — Withings Body Scan

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

Problems Solutions

Scale does not wake up when I step on it.	- Make sure your Withings Body Scan has enough battery life. Recharge your scale if necessary as described in this user guide. - Battery in sleep mode (before installation/configuration).
I'm having syncing issues with my scale.	- Make sure that your Withings Body Scan appears in Devices in the Withings Application. 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 20 seconds. - If necessary, reboot your mobile phone.
I want to change the units of my scale (lb, kg, st lb).	- Press the button located on the front side of your scale. - Press the button again to make the arrow point towards the right unit. - Press the button once more and maintain it until the progress bar is complete.

Technical specifications \_Wireless information

Product Name: Withings Body Scan

Model: WBS08

ECG Sensors: 2 stainless steel electrodes (handle) and 1 ITO electrode (glass plate)

Battery Operated: 1 year typical use on a single charge

Power Source: Power internally by a 3.6 Vdc Lithium ion battery (use the USB-C charging cable included) and a DC 5V power adapter with a minimum power of 3W and a maximum power of 5W.

Heart Rate Measurement Range: 30 bpm to 230 bpm

Display: Color 3.2inch LCD screen

Weight Withings Body Scan: 4.8kg (10.6lb)

Operation time: 60 seconds

Parts in contact with the skin: Glass plate of the scale and Handle with its electrodes

Weight Units: Kilograms (kg), Pounds (lb), Stone (st lb)

Weight range: 5kg - 200kg | 11lb - 440lb | 1st - 31st

Nerve Health Score measurement accuracy: <0.1%

Transport and storage conditions: -10^ ( 14^ ) – 50^ ( 122^ )

10% - 90%

86kPa - 106kPa

Max altitude: 2000m

Operation conditions: 5°C (41°F) - 35°C (95°F)

20% - 80%

86kPa - 106kPa

Max altitude: 2000m

IP Protection level: IP22

Mode of operation: Continuous Operation

Expected product life: 3 years

Wireless Specifications

Mode Frequency Band (MHz) Maximum Output Power (dBm)

BT LE 2412-2472 8 dBm, 2.4G

WLAN 2400 20 dBm

The wireless communication of the device is supported by BLE and Wi-Fi communication. This communication is established between the device and the Withings application.

The communication between the device and the Withings application is encrypted through an exchange of a paired key.

The communication latency between the device and the Withings application takes less than 10 seconds when the device and the smartphone are less than 16 feet (5 meters) apart.

The communication between the device and the Withings application is not modified with sources of interference located within 5 meters. Wireless coexistence has been tested in accordance with the following standards:

- ANSI C63.27:2017 and,

- AAMI TIR69:2017

Electromagnetic disturbances have been tested in accordance with the standard IEC 60601-1-2:2014.

Cleaning, Maintenance and Storage

Cleaning and maintenance of Withings Body Scan

• It is recommended to clean the glass plate and the handle electrodes of the scale before each measurement.
• Use only a cloth dampened with warm water to clean your scale. The use of any detergents or cleaners may cause irreversible damage to the conductive coating on top of the glass plate.
• Do not use the device while doing cleaning and maintenance operations.
• To recharge the battery, follow instructions in this guide.

Storage

• After a measurement using the handle, lower slowly so it rolls back into the scale without any sudden drop.
• Store the device in a clean and safe location between use.
• If storage conditions are different from the operating conditions indicated in the technical specifications, wait 30 minutes before taking a measurement

Europe - EU Declaration of Conformity

Withings hereby declares that the device Withings Body Scan is in conformity with the essential requirements and other relevant requirements of the applicable EU Directives and Regulations. The full text of the EU declaration of conformity can be found at: withings.com/compliance

Safety and performance

Withings Body Scan contributes to early detection of peripheral autonomic neuropathy. It facilitates patient screening and helps physicians treat the disease earlier and thus attenuates the impact of the disease on the population. It allows users to monitor disease advancement or regression. It also increases awareness of physiological conditions in the general user population. Withings Body Scan's ability to accurately measure Electrochemical Skin Conductance (ESC), also known as Galvanic Skin Response (GSR), was validated in a clinical study by comparison with a reference device, the Sudoscan. The mean difference (resp. standard deviation of paired differences) was 1.6 (resp. 3.5).

RF Statement

Medical electrical equipment needs special precautions regarding 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.

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
CE emissions CISPR11	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.
RE emissions CISPR11 Class B
Harmonic emissions IEC 61000-3-2	Not 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.
Voltage fluctuations/ Flicker emissions IEC 61000-3-3	Not applicable

Safety and performance

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

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

Immunity test	IEC 60601 Test Level	Compliance Level	Electromagnetic environment - guidance
Conducted RFIEC 61000-4-6	3 Vrms150kHz to 80MHz	N/A N/A
Radiated RFIEC 61000-4-3	3 V/m80 MHz to 2.5 GHz	N/A	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: A .
Electrostatic discharge (ESD)IEC 61000-4-2	Contact: ±8 kVAir: ±2 kV, ±4 kV, ±8 kV, ±15 kV	Contact: ±8 kVAir: ±2 kV, ±4 kV, ±8 kV, ±15 kV	Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material the relative humidity should be at least 30%.
Electrical fast transient/burstIEC 61000-4-8	2 kV for power supply lines1 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 mode2 kV common mode		line(s) to line(s);+/- 1kV	The main power quality should be of the kind used in a typical commercial or hospital environment.
Voltage dips, shortinterruptions and voltagevariations on power supplyinput lines IEC 61000-4-11	-5% UT (95% dip in UT) for 0.5 cycles, -40% UT (60% dip in UT)for 5 cycles, -70% UT (30% dip in UT) for 25 cycles, -5% UT (95% dip in UT) for 5 sec	N/A 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 (50/60Hz)magnetic field IEC 61000-4-8	30 A/m50 Hz or 60 Hz	30 A/m50 Hz or 60 Hz	The power frequency magnetic field should be at levels characteristic of a typical location in a typical commercial or hospital environment.

EN

FR

Disposal Warranty

Actuation of European directive 2012/19/EU, for reduction in use of dangerous substances in the electric and electronic device and for garbage disposal. The symbol applied on the device or its packaging means that at the end of its useful life, the product 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 and 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 deriving from inadequate disposal. It also allows the recovery of materials it is composed of to save energy and resources and avoid negative effects to the environment and health. In case of abusive disposal of devices by the user, will be applied administrative endorsements in compliance with current standards. The device and its parts must be disposed of as appropriate, in accordance with national or regional regulations.

Withings™ Two (2) Years Limited Warranty - Withings Body Scan

Withings, 2 rue Maurice Hartmann, 92130 Issy-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"). Withings' published guidelines include but are not limited to information contained in technical specifications, safety instructions or the quick start guide. Withings does not warrant that the operation of 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.

Need help?

→ withings.com/support

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. 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. The Withings application is not intended to be used on a computer. No indication of 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.

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Poids supportés : 5kg - 200kg | 11lb - 440lb | 1st - 31st

? Need help? → withings.com/support

Sécurité

Sponsor Australian Emergo Australia Level 20, tower II, Darling Park, 201 Sussex Street, Sydney, NSW 2000, Australia

Personne Responsable au Royaume-Uni Emergo Consulting (UK) Ltd c/o Cr360 - UL International Compass House, Vision Park Histon Cambridge CB24 9BZ United Kingdom

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→withings.com/support

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Australischer Sponsor Emergo Australia Level 20, tower II, Darling Park, 201 Sussex Street, Sydney, NSW 2000, Australia

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→ withings.com/support

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Painoalue: 5kg - 200kg | 11lb - 440lb | 1st - 31st

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? Need help? → withings.com/support

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Responsabile per il Regno Unito Emergo Consulting (UK) Ltd c/o Cr360 - Ul. International Compass House, Vision Park Histon Cambridge CB24 9BZ United Kingdom

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Seguridad

Emergo Australia Level 20, tower II, Darling

Bark 201 Sussex Street, Sydney NSW 2000

Park, 201 Australia

Emergo Consulting (UK) Ltd c/o Cr360 -

UL International Compass House, Vision Park

Histon Cambridge CB24 9BZ

United Kingdom

PŘÍRUČKA K PRODUKTU

UŽIVATELSKÁ PŘÍRUČKA – CZ

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Bezpečnost

Australsky sponzor Emergo Australia Level 20, tower II, Darling Park, 201 Sussex Street, Sydney. NSW 2000, Australie

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Bezpieczeństwo

Level 20, Tower II. Darling Park, 201 Sussex Street, Sydney, NSW 2000 Australia

Patrocinador australiano Emergo Australia Level 20, tower II, Darling Park, 201 Sussex Street, Sydney, NSW 2000, Australia Responsável no Reino Unido Emergo Consulting (UK) Ltd c/o Cr360 - UL International Compass House, Vision Park Histon Cambridge CB24 9BZ Reino Unido

GHIDUL PRODUSULUI

GHID DE UTILIZARE - RO - REGIUNILE DIN AFARA SUA

Interval de greutate: 5kg - 200kg | 11lb - 440lb | 1st - 31st

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Securitatea

Sponsor australian Emergo Australia Level 20, tower II, Darling Park, 201 Sussex Street, Sydney, NSW 2000, Australia

Responsabil din Regatul Unit Emergo Consulting (UK) Ltd c/o Cr360 - UL International Compass House, Vision Park Histon Cambridge CB24 9BZ Regatul Unit

TERMÉKISMERTETŐ

HASZNÁLATI ÚTMUTATÓ - HU

AZ USA-N KÍVÜLI RÉGIÓK

Three-step illustration showing foot being held in a device, with checkmarks indicating confirmation steps.

HU

SK

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Biztonság

Emergo Australia Level 20, tower II, Darling Park, 201 Sussex Street, Sydney, NSW 2000, Australia Emergo Consulting (UK) Ltd c/o Cr360 - UL International Compass House, Vision Park Histon Cambridge CB24 9BZ United Kingdom

NÁVOD NA POUŽITIE

NÁVOD NA POUŽITIE - SK

REGIÓNY MIMO USA

https://www.withings.com/guides

Three-step illustration showing foot measurement in a digital display with checkmarks indicating completion or confirmation steps.

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Bezpečnost

Austrálsky sponzor Emergo Austrália Level 20, Tower II, Darling Park, 201 Sussex Street, Sydney, NSW 2000, Austrália

Zodpovedná osoba vo Velkej Británií Emergo Consulting (UK) Ltd c/o Cr360 - UL International Compass House, Vision Park Histon Cambridge CB24 9BZ Spojené královstvo

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