WITHINGS WBS13 Body Composition Smart Wi-Fi Scale User Guide

WITHINGS WBS13 Body Composition Smart Wi-Fi Scale

Important notice

Before using Withings Body Smart, 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 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 Smart should be reported to Withings 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-Moulineaux, FRANCE

Intended Use (Non U.S. Regions)

Winthings Body Smart 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 Smart 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.

• 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.

• 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 Withings Body Smart 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 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 Withings 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 Withings 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 Smart 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 Smart 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 Withings Body Smart is on a stable floor, and that you have activated and enabled a Nerve Health Score measurement in the Withings application.
• Step on the scale with bare feet. Make sure your feet are clean and well positioned on the electrodes.
• Withings Body Smart 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.

• Results on the device

• Results on the device

• Results on the device

Troubleshooting — Withings Body Smart

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

• Make sure your Withings Body Smart has functional alkaline cells. Change them if necessary.

’m having syncing issues with my scale.|

• Make sure that your Withings Body Smart appears in Devices in the Withings application. If not, please install it.
• Make sure your Withings Body Smart has functional alkaline cells. Change them if necessary.
• If your Withings Body Smart 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 Smart

• Model: WBS13

• 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

• IP Protection level: IP22

• Mode of operation: Continuous Operation

• Expected product life: 3 years 2000m

Wireless information

Wireless Specifications

The wireless communication of the Withings Body Smart is supported by BLE and Wi-Fi communication. This communication is established between the Withings Body Smart and the Withings application. The communication between the Withings Body Smart and the Withings application is encrypted through an exchange of a paired key.

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

The communication between the Withings Body Smart 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/(R2020)

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

Cleaning, Maintenance and Storage

Cleaning and maintenance the Withings Body Smart

• 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

Withings hereby declares that the device Withings Body Smart 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 Smart 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.
Withings Body Smart’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

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

Emissions Test|

Compliance

| Electromagnetic environment – guidance
---|---|---
CE emissions CISPR11|

Group 1

| Withings Body Smart 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|

N/A

| Withings Body Smart 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

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.

Immunity test| IEC 60601 Test Level| Compliance Level| Electromagnetic environment – guidance
---|---|---|---
Conducted RF
IEC 61000-4-6| 3 Vrms 150kHz to 80MHz| N/A| N/A
Radiated RF
IEC 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: .
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| 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.

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

Withings™ Two (2) Years Limited Warranty – Withings Body smart 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 Withings 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 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.

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
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
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 Mark
Complies with FCC regulations
Unique device identifier
Serial number
FSC
Importer
Swiss Authorized Representative

Additional languages

This guide can be found in the following languages here:

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

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