4.6 Electromagnetic compatibility (technical description)
4.6.1 Precautions of use
This electronic control is in compliance with electrical safety standards in line with standard IEC 60601-1, edition 3.1, and those governing
electromagnetic compatibility in line with standard IEC 60601-1-2, fourth edition.
CAUTION
The device must be used by a competent person, in particular in compliance with the legal provisions in force regarding occupational
safety, health and accident prevention measures, and the current instruction for use. According to these measures, the user has the
following obligations:
• to only use devices that are in perfect working order
• to make sure that the device is used solely for the purpose for which it is intended
• avoid contact with liquids.
4.6.2 Electromagnetic compatibility
CAUTION
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The Chiropro Plus 3
phones, etc., should not be used in the immediate vicinity of the device, since this could affect its operation. The device is not suitable for
being used close to high-frequency surgical equipment, magnetic resonance imaging (MRI) and other similar devices where the intensity
of electromagnetic disturbances is high. In any case, ensure that no high frequency cables are routed above or near the device. If in doubt,
contact a qualified technician or Bien-Air Dental SA.
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 Chiropro Plus 3
the performance of this equipment could result.
CAUTION
The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by Bien-Air
Dental SA as spare parts for internal components, may result in increased emissions or decreased immunity.
4.6.3 Electromagnetic compatibility – emissions & immunity
Guidance and manufacturer's declaration – Electromagnetic emissions
rd
The Chiropro Plus 3
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Chiropro Plus 3
Gen must ensure that it is actually used in such an environment.
Emissions test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC
61000-3-2
Emissions due to voltage
fluctuations IEC 61000-3-3
Guidance and manufacturer's declaration – Electromagnetic immunity
rd
The Chiropro Plus 3
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Chiropro Plus 3
Gen must ensure that it is actually used in such an environment.
Immunity test
Electrostatic discharge
(ESD)
IEC 61000-4-2
8
Gen complies with the EMC requirements according to IEC 60601-1-2. Radio transmitting equipment, cellular
Gen is intended for use in the electromagnetic environment specified below. The customer or the user of the
Compliance
Electromagnetic environment - guidance
The Chiropro Plus 3
Group 1
RF emissions are very low and are not likely to cause any interference in nearby elec-
tronic equipment.
Class B
The Chiropro Plus 3
Class A
dings and those directly connected to the public low-voltage power supply network
that supplies buildings used for residential purposes.
Conforming
Gen is intended for use in the electromagnetic environment specified below. The customer or the user of the
IEC 60601 test level
±8 kV contact
±2 kV air
±4 kV air
±8 kV air
±15 kV air
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Gen, including cables specified by the manufacturer. Otherwise, degradation of
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Gen uses RF energy for its internal operation only. Therefore, its
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Gen is suitable for use in any building, including residential buil-
Compliance level
±8 kV contact
±2 kV air
±4 kV air
±8 kV air
±15 kV air
Electromagnetic
environment - guidance
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.