Withings WBS13 Užívateľská príručka

Kategória
Osobné váhy
Typ
Užívateľská príručka
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WITHINGS
PRODUCT GUIDE
2
EN-US
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/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 Withings 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 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.
Intended Use (U.S. Regions)
!Warnings & safety notice
Withings Body Smart 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, Withings Body Smart 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.
- 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.
- 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.
This guide explains how to use your Withings Body Smart.
It applies to users in the United States of America.
EN – U.S. REGIONS
USER GUIDE
WITHINGS,
2 rue Maurice Hartmann,
92130 Issy-les-Moulineaux, FRANCE 1282
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- 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.
- 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.
!Warnings & safety notice
- 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 Withings application.
Please assign it to your user so that the scale can automatically
recognize the user during the next weigh-in.
How to use Withings Body Smart and take a first measurement
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EN-US Troubleshooting — Withings Body Smart
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 Smart has functional alkaline cells.
Change them if necessary.
I’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
batteries. Change the batteries 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 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.
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Technical specifications Wireless information
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 2.86 inch LCD screen
Weight Withings Body Smart: 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
The wireless communication of the Withings Body Smart is
supported by BLE and WiFi communication. This communica-
tion 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 ANSI AAMI IEC 60601-1-2:2014.
Mode Frequency Band (MHz) Maximum Output Conducted-
Power (dBm)
BT LE 2402-2480 5 dBm
WLAN 2412-2462 16 dBm
Wireless Specifications
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EN-US 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 dierent from the operating
conditions indicated in the technical specifications,
wait 30 minutes before taking a measurement.
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 aect
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
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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 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.
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.
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EN-US 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 o 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 dierent 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 eects to the
environment and health. In case of abusive disposal of devices by the
user, will be applied administrative endorse-ments in compliance with
current standards.The device and its parts must be disposed of as
appropriate, in accordance with national or regional regulations.
FR
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Warranty
Need help?
withings.com/support
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.
Security
Withings recommends that you add a passcode (personal identi-
fication 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, en-
couraging 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 ocial 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
1282
IP22
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
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
Histon
Cambridge CB24 9BZ
United Kingdom
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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.
Intended Use (Non U.S. Regions)
Contraindications
Do not use the device if you have a cardiac pacemaker, an
implantable cardioverter-defibrillator (ICD), or other implanted
electronic devices.
This guide explains how to use your Withings Body Smart.
It applies to users in Europe, UK, Switzerland, Australia, New Zealand and Hong Kong.
EN – NON U.S. REGIONS
USER GUIDE
WITHINGS,
2 rue Maurice Hartmann,
92130 Issy-les-Moulineaux, FRANCE 1282
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.
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!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 equipmentcould 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
aect the results of the Nerve Health Score.
- Measurement results may be impacted in case of lower limb
amputation.
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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.
- 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.
How to use Withings Body Smart
and take a first measurement
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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.
Results on the device
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.
Results on the device
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
Nerve Health Score Outputs and interpretations
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Troubleshooting — Withings Body Smart
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 Smart has functional alkaline cells.
Change them if necessary.
I’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.
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Wireless information
Wireless Specifications
Mode Frequency Band (MHz) Maximum Output Conducted
Power (dBm)
BT LE 2402-2480 5 dBm
WLAN 2412-2472 16 dBm
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.
Technical specifications
-10°C (14°F) — 50°C (122°F)
10% — 90%
86kPa — 106kPa
5°C (41°F) — 35°C (95°F)
20% — 80%
86kPa — 106kPa
IP22
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:
Max altitude: 2000m
Operation conditions:
Max altitude: 2000m
IP Protection level:
Mode of operation: Continuous Operation
Expected product life: 3 years
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Cleaning, Maintenance and Storage
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 dierence (resp. standard deviation
of paired dierences) 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 aect
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
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
1282
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 dierent from the operating
conditions indicated in the technical specifications,
wait 30 minutes before taking a measurement.
17
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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 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.
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.
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Disposal 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
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 eects to the environment and health. In case of
abusive disposal of devices by the user, will be applied administrative endorse-
ments in compliance with current standards.The device and its parts must be
disposed of as appropriate, in accordance with national or regional regulations.
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 ocial 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
1282
IP22
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
!
1282
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
HistonCambridge CB24 9BZ
United Kingdom
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19
Informations importantes
Avant d’utiliser Withings Body Smart, lisez les informations
contenues dans ce guide. Ce guide est également
disponible en ligne à l’adresse suivante :
https://www.withings.com/fr/fr/guides
Conservez ce document pour toute référence ultérieure.
Les instructions d’installation sont disponibles dans le Guide de
Démarrage Rapide fourni avec ce guide d’utilisation.
Veuillez contacter Withings si vous avez besoin d’aide pour
installer, utiliser ou entretenir l’appareil, ou pour signaler des
opérations ou des événements inattendus.
Tout incident grave lié à Withings Body Smart doit être signalé
à Withings et aux autorités compétentes du pays dans lequel
vous résidez.
Avertissement
Les informations contenues dans ce guide peuvent être
modifiées sans préavis.
WITHINGS,
2 rue Maurice Hartmann,
92130 Issy-les-Moulineaux, FRANCE 1282
Ce guide explique comment utiliser Withings Body Smart.
Cela s’applique aux utilisateurs au Royaume-Uni, en Europe,
en Suisse, en Australie, en Nouvelle-Zélande et à Hong-Kong.
FR – RÉGIONS EUROPE
GUIDE UTILISATEUR
N’utilisez pas Withings Body Smart si vous portez un stimulateur
cardiaque, un cardioverteur-défibrillateur implantable (DCI) ou
d’autres dispositifs électroniques implantés.
Contre-indications
Utilisation prévue (régions Europe)
Body Smart est une balance connectée, à but non-médical,
orant les fonctionnalités suivantes :
- Calcul du poids
- Calcul de l’indice de masse corporelle (IMC)
- Calcul de la composition corporelle
- Mesure de la fréquence cardiaque
- Mesure de la vitesse de l’onde de pouls
- Estimation de l’âge vasculaire
De plus, Withings Body Smart est destinée à détecter et à suivre
les neuropathies autonomes périphériques chez les adultes
en eectuant des mesures à partir de la peau des pieds, qu’elle
soit intacte ou endommagée (ampoules, callosités, plaies…)
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20 !
- L’auto-diagnostic et l’auto-médication peuvent être dangereux.
En cas de questions ou de doutes, consultez votre médecin.
- Une mauvaise utilisation de l’appareil peut entraîner des blessures.
- Ne montez pas sur la balance avec les pieds mouillés.
Les matériaux utilisés dans l’appareil peuvent potentiellement
engendrer des réactions allergiques lors du contact avec la peau.
- L’appareil n’est pas destiné à surveiller en continu les paramètres
vitaux dans des conditions critiques, ou lorsque la nature
des variations est telle qu’elle pourrait entraîner un danger
immédiat pour l’utilisateur.
- L’appareil ne donne pas d’alertes.
- Tenez l’appareil à l’écart des enfants et des animaux domestiques.
De petites pièces peuvent être inhalées ou avalées.
- L’exposition prolongée de l’appareil aux peluches, à la poussière
ou à la lumière (y compris la lumière du soleil) peut réduire
sa durée de vie ou l’endommager.
- Vérifiez que les électrodes ne sont pas déformées, endommagées
en surface ou corrodées et vérifiez qu’elles ne présentent
aucune autre forme de dommage.
- N’utilisez pas Withings Body Smart si elle est endommagée.
L’utilisation d’un appareil endommagé pourrait causer
des blessures ou une défaillance de l’équipement.
- N’immergez pas la balance ou l’un de ses composants dans l’eau.
- N’essayez pas de réparer ou de modifier cet appareil vous-même.
Aucune réparation ne doit être eectuée sur Body Smart en
dehors de l’entretien indiqué dans le guide produit de l’appareil.
- Aucune modification de cet équipement n’est autorisée.
- La consommation d’alcool jusqu’à 24 heures avant la prise de
mesure peut aecter les résultats du Score de Santé Nerveuse.
- N’utilisez pas d’accessoires, de pièces détachées ou de matériaux
non spécifiés dans le guide produit. L’utilisation de pièces et de
composants autres que ceux spécifiés ou fournis par le fabricant
de cet équipement pourrait entraîner une augmentation des
émissions électromagnétiques ou une diminution de l’immunité
électromagnétique de cet équipement, et entraîner un
fonctionnement incorrect.
- Les équipements de communication RF portables (y compris
les périphériques tels que les câbles d’antenne et les antennes
externes) ne doivent pas être utilisés à moins de 30 cm (12 pouces)
de toute partie de l’appareil, y compris les câbles spécifiés par
le fabricant. Dans le cas contraire, il pourrait en résulter
une dégradation des performances de cet équipement.
- L’utilisation de cet équipement à côté ou empilé avec d’autres
équipements doit être évitée car cela pourrait entraîner
un mauvais fonctionnement. Si une telle utilisation est nécessaire,
cet équipement et l’autre équipement doivent être surveillés
pour vérifier qu’ils fonctionnent normalement.
- Ne pas interconnecter cet équipement avec d’autres équipements
non décrits dans le guide produit.
- Respectez les conditions de fonctionnement et de stockage
décrites dans la section “spécifications techniques” du guide
produit de l’appareil. Dans le cas contraire, les résultats
des mesures peuvent être aectés.
- Évitez d’utiliser Withings Body Smart si vos pieds présentent
une mauvaise intégrité cutanée, comme des coupures,
des plaies ou une peau endommagée.
- L’utilisation de médicaments contenant des agents anticholiner-
giques peut avoir un impact sur les résultats du Score de Santé
Nerveuse. Si vous ne savez pas si vos médicaments ont des
propriétés anticholinergiques, demandez à votre médecin.
- Les résultats des mesures peuvent être aectés en cas
d’amputation d’un membre inférieur.
Avertissements
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Withings WBS13 Užívateľská príručka

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Užívateľská príručka