Withings Body Pro 2 Guia Del Usuario página 13

Safety and Performance
24
Withings Body Pro 2 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 Pro 2 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 devi-
ation 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 Pro 2 is intended for use in the electromagnetic environment specified below. The customer or the user of the Withings Body Pro 2 should ensure that it is used in such an
environment.
Emissions Test Compliance Electromagnetic environment – guidance
CE emissions CISPR11 Group 1
The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference
in nearby electronic equipment.
RE emissions CISPR11 Class B
Harmonic emissions N/A
IEC 61000-3-2 The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic purpose.
Voltage fluctuations/Flicker N/A
emissions IEC 61000-3-3
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
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such an environment.
Immunity test IEC 60601 Test Level Compliance Level
Conducted RF 3 Vrms N/A
IEC 61000-4-6 150kHz to 80MHz
Radiated RF 3 V/m N/A
IEC 61000-4-3 80 MHz to 2.5 GHz
Electrostatic discharge (ESD) Contact: ±8 kV Contact: ±8 kV
IEC 61000-4-2 Air: ±2 kV, ±4 kV, ±8 kV, ±15 kV Air: ±2 kV, ±4 kV, ±8 kV, ±15 kV
Electrical fast transient/burst 2 kV for power supply lines N/A
IEC 61000-4-8 1 kV for input/output lines
Surge IEC 61000-4-5 1 kV differential mode line(s) to line(s):
2 kV common mode +/- 1kV
Voltage dips, short -5% UT (95% dip in UT) for 0.5 N/A
interruptions and voltage cycles, -40% UT (60% dip in UT)
variations on power supply for 5 cycles, -70% UT (30% dip in
input lines IEC 61000-4-11 UT) for 25 cycles, -5% UT (95%
dip in UT) for 5 sec
Power frequency (50/60Hz) 30 A/m 30 A/m
magnetic field IEC 61000-4-8 50 Hz or 60 Hz 50 Hz or 60 Hz
Electromagnetic environment – guidance
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:
Floors should be wood, concrete, or ceramic tile. If floors are covered
with synthetic material the relative humidity should be at least 30%.
The main power quality should be of the kind used in a typical commercial or
hospital environment
The main power quality should be of the kind used in a typical commercial or
hospital environment
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.
The power frequency magnetic field should be at levels characteristic
of a typical location in a typical commercial or hospital environment.
25
EN-US
ES
EN
FR