Warning - Bien-Air Dental OPTIMA INT Instructions D'installation

OPTIMA INT

Warning

Contenu
Precautions regarding Electromagnetic Compatibility (EMC)
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 user's manual and in the present document.
The OPTIMA INT complies with the EMC requirements according to IEC 60601-1-2. Radio transmitting equip-
ment, cellular phones, etc. shall not be used in the close proximity of the device since this could influence the
performance of the device. Particular precaution must be considered during use of strong emission sources
such as High Frequency surgical equipment and similar so that e.g. the HF cables are not routed on or near
the device. If in doubt, please contact a qualified technician or Bien-Air Dental.
The OPTIMA INT should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the OPTIMA INT should be observed to verify normal operation in the
configuration in which it will be used. The intended EM environment (per IEC 60601-1-2 ed. 4.0) is Professional
healthcare facility environment. Any use other than that for which this product is intended is unauthorized and
may be dangerous. The medical device meets all the current legal requirements.
WARNING !
The use of accessories, transducers and cables other than those specified, with the exception of transduc-
ers and cables sold by Bien Air Dental as replacements parts for internal components, may result in
increased emissions or decreased immunity of the OPTIMA INT. 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.
Guidance and manufacturer's declaration - electromagnetic emissions
The OPTIMA INT is intended for use in the electromagnetic environment specified below.
The customer or the user of the OPTIMA INT should assure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions IEC
61000-3-3
Compliance Electromagnetic environment - guidance
Group 1 The OPTIMA INT 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.
Class B The OPTIMA INT is suitable for use in all Establishments,
including domestic establishments and those directly con-
nected to the public low-voltage power supply network that
Not applicable supplies buildings used for domestic purposes.
Not applicable
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