WITHINGS WBS12 Body Comp Analysis Smart WiFi Scale User Guide

PRODUCT GUIDE

This guide explains how to use your Witlings Body Comp. It applies to users in the United States of America.

WBS12 Body Comp Analysis Smart WIFI Scale

Important notice
Before using Witlings Body Comp, review the information in this guide. You may also find this guide online at: https://www.withings.com/us/en/guides
Retain this documentation for future reference.
Installation instructions are available within the Quick Start Guide provided with this user guide.
Please contact Witlings when in need of assistance, setting up, using or maintaining the device or to report unexpected operations or events.
Any serious incident related to the Witlings Body Comp should be reported to Witlings and competent authorities in your country of residence.
Disclaimer
Information in this guide may change without notice.

WITHINGS,
2 rue Maurice Hartmann,
92130 Issy-les-Molineux, FRANCE
Intended Use (U.S. Regions)
Witlings Body Comp is a connected smart scale providing the following wellness features:
– measure weight
– calculate Body Mass Index (BMI)
– measure pulse rate
– estimate vascular age
– compute electrodermal activity score
Additionally, Witlings Body Comp is intended: to measure body composition for weight management purposes, and to maintain healthy levels of muscle, bone and fat mass, and encourage healthy living. It is intended for use in adults.
Warnings & safety notice
– Self-diagnosis and self-treatment can be dangerous.
Always consult your doctor in case of questions or doubts.
– Do not use the device if you have a cardiac pacemaker, an  implantable cardioverter-defibrillator (ICD), or other implanted  electronic devices.
– If you are pregnant, accuracy may be impacted for body  composition analysis, electrodermal activity score, vascular age.  Consult your doctor during pregnancy.
– Misuse of the device can cause injury.
– Do not step on the scale with wet feet. Potential allergic reactions  may occur due to contact with materials used in the device.
Warnings & safety notice
– 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 life or damage it.
– Inspect electrodes for warping, surface damage or corrosion  and check for any other form of damage.
– Do not use the device 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 device other than the maintenance listed in this guide.
– Do not use accessories, detachable parts, or materials not  described in the product guide.
– Avoid using the device on feet with poor skin integrity, such as  cuts, wounds or damaged skin.
– No modification of this equipment is allowed.
– Use of accessories, transducers and cables 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 product guide.
– Follow operational and storage conditions as described in  the technical specifications section of this guide. Otherwise,  measurement results may be impacted.
How to use Witlings Body Comp and take a first measurement

– Follow the information in the Quick Start Guide and in the  Witlings application to set-up your device.
– To wake up your device for the first time, please pull the tab in  the battery cover. If there is no tab, press the power button for  3 seconds if needed. Once your product is installed and  configured, it will appear in your Devices list in  settings.
– To take the first measurement, step on the scale with bare feet.
Your name, or trigram (as configured in the Witlings application), 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 Witlings  application) will follow.
– If it is not the case, the measurement will most likely appear in  “Unknown Measurements” in the Witlings application.  Please assign it to your user so that the scale can automatically  recognize the user during the next weigh-in.

Troubleshooting — Witlings Body Comp

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

has functional alkaline cells.
Change them if necessary.
I’m having syncing issues with my scale.| – Make sure that your Witlings Body Comp appears in Devices in  the Witlings  application. If not, please install it.
– Make sure your Witlings Body Comp has functional alkaline  batteries. Change the batteries if necessary.
– If your Witlings Body Comp 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 by removing a battery.
– 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 back 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.

Product Name: Withings Body Comp
Model: WBS12
Battery Life: 15 months typical use
Power Source: Four (4) alkaline cells – AAA
Heart Rate Measurement Range: 30 bpm to 230 bpm
Display: Color 2.86 inch LCD screen
Weight Withings Body Comp: 2.2kg
Operation time: 30 seconds
Parts in contact with the skin: Glass plate of the scale
Weight Units: Kilograms (kg), Pounds (lb), Stone (st lb)
Weight range: 5kg – 200kg I 11lb – 440lb I 1st – 31st
Electrodermal Activity Score measurement accuracy: <0.1%
Transport and storage conditions:
-10°C (14°F) — 50°C (122°F)
10% — 90%
86kPa — 106kPa
Max altitude: 2000 m
Operation conditions:
5 °C (41 °F) — 35 °C (95 °F)
20 % — 80 %
86kPa — 106kPa
Max altitude: 2000 m
IP Protection level: IP22
Mode of operation: Continuous Operation
Expected product life: 3 years

Wireless information

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

The wireless communication of the Witlings Body Comp is supported by BLE and WIFI communication. This communication is established between the Witlings Body Comp and the Witlings application. The communication between the Witlings Body Comp and the Witlings application is encrypted through an exchange of a paired key.
The communication latency between the Witlings Body Comp and the Witlings application takes less than 10 seconds when the Witlings Body Comp and the smartphone are less than 16 feet (5 meters) apart.
The communication between the Witlings Body Comp and the Witlings 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/(R2020)
Electromagnetic disturbances have been tested in accordance with the standard ANSI AAMI IEC 60601-1-2:2014.

Cleaning, Maintenance and Storage

Cleaning and maintenance the Witlings Body Comp
– It is recommended to clean the glass plate 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.

Storage
– 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.

Safety and performance

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

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 emissionsIEC 61000-3-2| N/A| Witlings Body Comp  is suitable for use in all establishments, including domestic establishments  and those directly connected to the  public low-voltage power supply network that  supplies wildings used for domestic purposes.
Voltage fluctuations/Flicker emissions IEC 61000-3-3| N/A

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

Immunity test| IEC 60601 Test Level| Compliance Level| Electromagnetic environment – guidance
---|---|---|---
‘Conducted RF EC 61000-4-6| 3 Vims 150kHz to 80MHz| N/A| N/A
Radiated RF EC 61000-4-3| 3 V/m
80 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: 1)10 .
Electrostatic discharge (ESD) EC 61000-4-2| Contact: ±8 kV
Air: ±2 kV. ±4 kV. ±8 kV. ±15 kV| Contact: ±8 kV
Air: ±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/burst EC 61000-4-8| 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| 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, short
nterruptions and voltage ianations on power supply nput 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.
‘over frequency (50/60Hz) Tiagnetic field IEC 61000-4-8| 30 A/m
50 Hz or 60 Hz| 30 A/m
50 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.

Federal Communication Commission interference statement

This device complies with part 15 of the FCC 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 Caution: 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 15 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, if 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 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 should 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 endorse- mints in compliance with current standards. The device and its parts must be disposed of as appropriate, in accordance with national or regional regulations.
Warranty Witlings™ Two (2) Years Limited Warranty – Witlings Body Comp Witlings, 2 rue Maurice Hartmann, 92130 Issy-les-Molineux, («Witlings») warrants the Witlings-branded hardware product («Witlings Product») against defects in materials and workmanship when used normally in accordance with Witlings’ published guidelines for a period of TWO (2) YEARS from the date of original retail purchase by the end-user purchaser («Warranty Period»). Witlings’ published guidelines include but are not limited to information contained in technical specifications, safety instructions or the quick start guide. Witlings does not warrant that the operation of the Witlings Product will be uninterrupted or error-free.
Witlings is not responsible for damage arising from failure to follow instructions relating to the Witlings Product’s use.
Need help?

withings.com/support

Security
Witlings 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 Witlings application, 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 Witlings 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 Witlings application. In case of doubt, use the link go.withings.com.

Equipment Symbol Description

Do not dispose of this product as unsorted municipal waste, take it to electronic recycling.
Read the Instruction Manual before use
Direct Current

1282
The CE labeling certifies that the product complies with the general safety and performance requirements of Regulation 2017/745
Medical device
Medical device manufacturer
Temperature range
Upper and lower limits of pressure
Upper and lower limits of relative humidity
IP22 Ingress of water or particulate matter
Type BF-Applied Part (glass plate)
Do not use if package is damaged and consult instructions for use
Caution
Regulatory Compliance ark
Complies with FCC regulations
Unique device identifier
Serial number
FSC
Importer
Swiss Authorized Representative

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

USER GUIDE
NON U.S. REGIONS
This guide explains how to use your Witlings Body Comp It applies to users in Europe, United Kingdom, Switzerland, Australia, New Zealand and Hong Kong.
Important notice
Before using Witlings Body Comp, 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 within the Quick Start Guide provided with this user guide.
Please contact Witlings 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 Witlings Body Comp should be reported to Witlings and competent authorities in your country of residence.
Disclaimer
Information in this guide may change without notice.

WITHINGS,
2 rue Maurice Hartmann,
92130 Issy-les-Molineux, FRANCE 1282
Intended Use (Non U.S. Regions)
Win things Body Comp 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, Witlings Body Comp 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.
Contraindications
Do not use the device 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 doubts.
– If you are pregnant, accuracy may be impacted for body composition analysis, Nerve Health Score, vascular age. Consult your doctor during pregnancy.
– Misuse of the device can cause injury.
– Do not step on the scale with wet feet. Potential allergic reactions may occur due to contact with materials used in the device.
– 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 life or damage it.
– Inspect electrodes for warping, surface damage or corrosion and check for any other form of damage.
– Do not use the device 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 device other than the maintenance listed in this guide.
– Do not use accessories, detachable parts, or materials not described in the product guide.
– Use of accessories, transducers and cables 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 product guide.
– Follow operational and storage conditions as described in the technical specifications section of this guide. Otherwise, measurement results may be impacted.
– Avoid using the device on feet with poor skin integrity, such as cuts, wounds or damaged skin.
– No modification of this equipment is allowed.
- 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.
– Measurement results may be impacted in case of lower limb amputation.

How to use Witlings Body Comp and take a first measurement

– Follow the information in the Quick Start Guide and in the  Witlings application to set-up your device.
– To wake up your device for the first time, please pull the tab in  the battery cover. If there is no tab, press the power button for  3 seconds if needed. Once your product is installed and  configured, it will appear in your Devices list in settings.
– To take the first measurement, step on the scale with bare feet.  Your name, or trigram (as configured in the Witlings application),  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 Witlings  application) 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 Comp 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.
– Witlings Body Comp 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 innervate  the sweat glands. The degeneration of these small nerve fibers  reduces sweat gland innervation and impairs the sudomotor  function.

Taking a Nerve Health Score
Measurement
How to get a Nerve Health Score:
– Make sure the Witlings Body Comp is on a stable floor, and  that you have activated and enabled a Nerve Health Score  measurement in the Witlings application.
– Step on the scale with bare feet. Make sure your feet are clean  and well positioned on the electrodes.
– Witlings Body Comp will give you a final Nerve Health Score 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.

Nerve Health Score Outputs and interpretations

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 your doctor before making any medical decisions. You can help keep your nerves healthy by taking care of your overall health. This includes proper hydration, healthy eating, getting regular physical activity, getting enough  restful sleep 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 proper hydration, healthy eating, getting regular physical activity, getting enough restful sleep and working with your doctor to manage any health
issues that you may have.

Pending
The reading might be pending 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.

Troubleshooting — Witlings Body Comp

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

has functional alkaline cells. Change them if necessary.
I’m having syncing issues with my scale.| – Make sure that your Witlings Body Comp appears in Devices in the Witlings application. If not, please install it.
– Make sure your Witlings Body Comp has functional alkaline cells.
Change them if necessary.
– If your Witlings Body Comp 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 back of your scale.
– Press the button again to make the arrow point towards the right unit.
– Press and hold the button until the progress bar reaches the right edge of the screen.

Technical specifications

Product Name: Withings Body Comp
Model: WBS12
Battery Life: 15 months typical use
Power Source: Four (4) alkaline cells – AAA
Heart Rate Measurement Range: 30 bpm to 230 bpm
Display: Color 2.86inch LCD screen
Device weight: 2.2kg
Operation time: 30 seconds
Parts in contact with the skin: Glass plate of the scale
Weight Units: Kilograms (kg), Pounds (lb), Stone (st lb)
Weight range: 5kg – 200kg I 11lb – 440lb I 1st – 31st
Nerve Health Score measurement accuracy: <0.1%

Transport and storage conditions:
-10°C (14°F) — 50°C (122°F)
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 information
Wireless Specifications

The wireless communication of the Witlings Body Comp is supported by BLE and Wi-Fi communication. This communication is established between the Witlings Body Comp and the Witlings application. The communication between the Witlings Body Comp and the Witlings application is encrypted through an exchange of a paired key.
The communication latency between the Witlings Body Comp and the Witlings application takes less than 10 seconds when the Witlings Body Comp and the smartphone are less than 16 feet (5 meters) apart.
The communication between the Witlings Body Comp and the Witlings 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/(R2020)
Electromagnetic disturbances have been tested in accordance with the standard IEC 60601-1-2:2014.
Cleaning, Maintenance and Storage
Cleaning and maintenance the Witlings Body Comp
– It is recommended to clean the glass plate 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.
Storage
– 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
Witlings hereby declares that the device Witlings Body Comp 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

1282

Safety and performance

Witlings Body Comp contributes to an early detection of peripheral autonomic neuropathy. It facilitates patient screening and helps physicians treat the disease earlier and thus attenuate 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. Witlings Body Comp’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 Suboscine. 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
Witlings Body Comp is intended for use in the electromagnetic environment specified below. The customer or the user of the Witlings Body Comp should ensure that it is used in such an environment.

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 emissionsIEC 61000-3-2| N/A| Witlings Body Comp  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 N/A|

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

immunity test| IEC 60601 Test Level| .
Compliance Level| .
Electromagnetic environment – guidance
---|---|---|---
Conducted RF EC 61000-4-6| 3 Vims
150kHz to 80MHz| N/A| N/A
Radiated RF
EC 61000-4-3| 3 V/m
80 MHz to 2.5 Gils| 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: W40.
Electrostatic discharge (ESD) IEC 61000-4-2| Contact: ±8 kV
Air: ±2 kV. ±4 kV. ±8 kV. ±15 kV| Contact: ±8 kV
Air: ±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/burst IEC 61000-4-8| 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| 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. short
interruptions and voltage variations on power supply input 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 L| 30 A/m
50 Hz or 60 Hz ..| 30 A/m
50 Hz or 60 Hz a.| The power frequency magnetic field should be at levels characteristic of a typical location in a typical commercial or hospital environment. .

Disposal
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 should 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.
Warranty
Witlings™ Two (2) Years Limited Warranty – Witlings Body Comp Witlings, 2 rue Maurice Hartmann, 92130 Issy-les-Molineux, («Witlings») warrants the Witlings- branded hardware product («Witlings Product») against defects  in materials and workmanship when used normally in accordance with Witlings’ published guidelines for a period of TWO (2) YEARS from the date of original retail purchase by the end-user purchaser («Warranty Period»). Witlings’  published guidelines include but are not limited to information contained in technical specifications, safety instructions or the quick start guide. Witlings does not warrant that the operation of the Witlings Product will be uninterrupted or error-free. Witlings is not responsible for damage arising from failure to follow instructions relating to the Witlings Product’s use.

Need help?
withings.com/support

Security
Witlings 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 Witlings application, 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 Witlings 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 Witlings application. In case of doubt, use the link go.withings.com.

Equipment Symbol Description

Do not dispose of this product as unsorted municipal waste, take it to electronic recycling.
Read the Instruction Manual before use
Direct Current
1282 The CE labeling certifies that the product complies with the general safety and performance requirements of Regulation 2017/745

** Medical device
Medical device manufacturer
Temperature range
Upper and lower limits of pressure
Upper and lower limits of relative humidity
IP22 Ingress of water or particulate matter
Type BF-Applied Part (glass plate)
Do not use if package is damaged and consult instructions for use
Caution
Regulatory Compliance ark
** Complies with FCC regulations
Unique device identifier
Serial number
FSC
Importer
**** Swiss Authorized Representative

https://www.withings.com/guides
Australian sponsor
Emergo Australia Level 20,
tower II, Darling Park, 201
Sussex Street, Sydney, NSW 2000, Australia
UK Responsible Person
Emergo Consulting (UK) Ltd
c/o Cr360 – UL International
Compass House, Vision Park
Hitson Cambridge CB24 9BZ
United Kingdom

Witlings Body Comp | Proactive Health
Tracking © 2023 Witlings.
All rights reserved. Mar. 2023
support.withings.com – 2 rue Maurice
Hartmann, 92130 Issy-les-Molineux, France

References

• Withings app
• Smart Scales, Watches and Health Monitoring Devices | Withings
• Compliance documents | Withings
• Withings | Smart Scales, Watches and Health Monitoring Devices
• Smart Scales, Watches and Health Monitoring Devices | WITHINGS
• Withings guides Documents
• Withings guides Documents
• Guides des produits Withings
• Guides documents | Withings
• Withings guides Documents

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