ENG
2.1 Identification
Medical device manufactured by Bien-
Air Dental SA.
Type
Reciprocating microsaw* handpiece,
with internal irrigation, without light, to
be connected to a E type short mi-
cromotor (ISO 3964).
*Hereafter: Microsaw
Classification
Class I according to FDA Code of
Federal Regulations 21 CFR 878.4820
relating to medical devices. This med-
ical device complies with the legislation
in force.
2.2 Intended use
The Microsaw is intended to be used in
oral and maxillofacial surgery for cut-
ting bone and hard tissues.
2.3 Intended patient
population
The intended patient population of the
Microsaw includes any person visiting a
dental or medical practitioners’ office
to receive treatment in line with the in-
tended medical condition. There is no
restriction concerning subject age,
race, or culture. The intended user is re-
sponsible to select the adequate device
for the patient according to the specific
clinical application.
2.4 Intended User
The microsaw is intended to be used by
oral and maxillofacial surgeons and
plastic surgeons in an operating room.
2.5 Intended medical
condition
Correction of craniofacial deformities,
including but not limited to bone tumor,
sleep apnea, cleft palate and bone graft-
ing therapy.
The main treatments may include:
l
Orthognathic surgery
l
Genioplasty
l
Rhinoplasty
2.6 Patient contra-
indications
No specific patient contra-indication ex-
ist for the Microsaw device family when
the device is used as intended.
2.7 In case of accidents
The Microsaw system (microsaw and
cutting tools) must not be used until re-
pairs of the microsaw have been
completed by a qualified and trained
technician authorized by the man-
ufacturer.
Damaged
or
deformed
cutting tools must be disposed of.
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.
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2 Identification & Intended Use
