ENG
2 Identification &
Intended Use
2.1 Identification
Medical devices manufactured by Bien-
Air Dental SA.
Type:
Hose with a short and rotating coupling,
ensuring easy use of the MC3 mi-
cromotor and its handpiece. For MC3
motors with and without light. Coupling
rotates through 400°. Hose Ø 10 mm.
Description:
Hoses are essential accessories meant
to
connect
motors
to
the
con-
soles/electrical drive motor board.
2.2 Intended use
Product intended for use in:
l
General dentistry which includes
restorative dentistry, dental pro-
phylaxis
and
orthodontics
treatments.
l
Endodontics
2.3 Intended patient
population
The intended patient population for the
device includes any person visiting a
dental practitioners’ office to receive
treatment in line with the intended med-
ical condition. There is no restriction
concerning subject age, race, or cul-
ture. The intended user is responsible
to select the adequate device for the pa-
tient according to the specific clinical
application.
2.4 Intended user
Product intended for professional use
only. Used by dentists and dental pro-
fessionals.
2.5 Use environment
Professional healthcare
facility en-
vironment.
2.6 Intended medical
conditions
General dentistry which includes res-
torative dentistry, dental prophylaxis,
orthodontics and addresses the main-
tenance or reestablishment of dental
health.
Endodontics procedure addresses root
canal treatment.
2.7 Patient contra
-indications and side effects
No specific patient contra- indication,
side effects nor warning exist for the
device when it is used as intended.
2.8 In case of accident
If an accident occurs, the device must
not be used.
If any serious incident occurs in relation
to the device, report it to a competent
authority of your country, as well as the
manufacturer through your regional
distributor. Observe relevant national
regulations for detailed procedures.
WARNING
Any use other than that for which this
device is intended is unauthorised and
may be dangerous.
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