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• The use environment of this device is the Professional healthcare facility environment.
• This device needs special precautions regarding EMD and needs to be installed and put into service according to the EMD information provided
in the ACCOMPANYING DOCUMENTS.
•
Use of parts other than those accompanied or specified by Bien-Air Dental SA could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this device and result in improper operation.
• Do not use this device as adjacent or stacked as possible with other. When adjoining or stacking is necessary, use it after observing whether this
equipment and other equipment work properly.
• Portable and mobile RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no
closer than 30 cm to any part of the HIM-2, including cables specified by the manufacturer.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
This device is intended for use in the electromagnetic environment specified below.
The customer or the user of this device should assure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment – Guidance
Conducted disturbance
CISPR 11
Group 1
Class B
This device uses RF energy only for its internal function. There-
fore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
Radiated disturbance
CISPR 11
Group 1
Class B
This 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 purposes.
Harmonic current
IEC 61000-3-2
Class A
Voltage fluctuations and flicker
IEC 61000-3-3
Clause 5
The Lubricare 2 (hereafter "this device") conforms to IEC 60601-1-2:2014 Ed. 4.0, the relevant international stan-
dard for electromagnetic disturbances (EMD).
The following is the “Guidance and Manufacturer's Declaration” which is required by IEC 60601-1-2:2014 Ed. 4.0,
the relevant international standard for electromagnetic disturbances.
This is a Group 1, Class B product according to EN 55011 (CISPR 11).
This means that this device does not generate and/or use internationally radio-frequency energy, in the form of
electromagnetic radiation, inductive and/or capacitive coupling, for the treatment of material or inspection/analy-
sis purpose and that it is suitable for use in domestic establishments and in establishments directly connected to
a low voltage power supply network which supplies buildings use for domestic purposes.
12 Electromagnetic Disturbances (EMD)
