3 User and Patient
Safety: Warnings and
Precautions for use
This medical device must be used by
professionals in compliance with the
legal provisions in force regarding oc-
cupational safety, health and accident
prevention measures, and these in-
structions for use.
In accordance with these provisions, the
user is responsible for ensuring he or
she only uses devices which are in per-
fect working order.
Electrical safety:
WARNING
Electrical safety in conformance with
IEC 60601-1 can only be claimed when
the device is used with Bien-Air Dental
compatible devices (drive motors and
motors). In addition, only medical
power supply with 2 MOPP should be
used.
Electromagnetic compatibility:
WARNING
l
Electromagnetic compatibility can
only be claimed when the device is
used with Bien-Air Dental com-
patible devices (drive motors and
motors).
l
Since compliance with the in-
ternational standard IEC60601-1-
2 does not guarantee immunity
against 5G worldwide (due to the
different frequency bands used
locally), avoid the presence of
devices equipped with 5G broad-
band cellular networks in the
clinical environment or ensure
that the network functionality of
these devices is disabled during
the clinical procedure.
To prevent any risk of explosion, the
warnings below must be observed:
WARNING
According to IEC 60601- 1:2005 +A1
2012 / AnnexG, electrified devices (mo-
tors,
control
units,
couplers
and
attachments), can be safely used in a
medical environment in which po-
tentially
explosive
or
flammable
mixtures of anaesthetic substances are
delivered to the patient only if:
l
The distance between the motor
and the anaesthetic breathing cir-
cuit exceeds 25 cm.
l
The motor is not used sim-
ultaneously to the administration
of the anaesthetic substances to
the patient.
To prevent any risk of infection, the
warning below must be observed:
WARNING
l
Medical personnel using or per-
forming maintenance on medical
devices that are contaminated or
potentially contaminated
must
comply
with
universal
pre-
cautions, in particular the wearing
of personal protective equipment
(gloves, goggles, etc.). Pointed and
sharp
instruments should
be
handled with great care.
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