Intended Use; Safety Requirements - mectron Piezosurgery II Manual Of Use And Maintenance

MANUAL OF USE AND MAINTENANCE
The Piezosurgery is a piezoelectric device for bone surgery that enables osteotomy and
osteoplasty techniques to be applied to in almost any anatomical situation. This equip-
ment can be used in the following fields:
- Oral Surgery:
Extraction - Apicectomy - Cystectomy - Osteogenic distraction.
- Implantology:
Bone window osteotomy - Crest expansion - Bone fragment removal - Monocortical
bone removal - Osteoplasty - Final preparation of the implant site - Extraction for im-
mediate implantation - Elevation of Schneider's membrane.
- Periodontal Surgery:
Osteotomy and osteoplasty techniques - Removal of bone tissues in regeneration sur-
gery - Root debridement - Root planing.
- Surgical Orthodontics:
Exposure or extraction of embedded teeth - Orthodontic corticotomy.
This equipment may be used only in a dentist's surgery or out-patient's department where
there are no inflammable gases (anaesthetic mixtures, oxygen, etc.).
Mectron will not accept any liability for direct or incidental personal injury or damage to
property in the following cases:
1 If the equipment is used for purposes other than that for which it is intended.
2 If the equipment is not used in accordance with all the instructions and requirements
described in this manual.
3 If the wiring system in the room where the equipment is used does not comply with the
applicable standards and appropriate requirements.
4 If any assembly operations, extensions, settings, alterations or repairs have been car-
ried out by personnel not authorised by Mectron.
5 If the environmental conditions in which the device is kept and stored do not comply
with the requirements indicated in the chapter on technical specifications.
DANGER: Qualified and specialised personnel.
This equipment may be used only by specialised and suitably trained personnel such as
surgeons. If correctly used, this equipment does not give rise to side effects. Improper
use, on the other hand, will give rise to transmission of heat to the tissues.
DANGER: Intended use.
Use the equipment solely for the purpose for which it is intended (see point "00.3"). Failure
to comply with this requirement could lead to serious harm to the patient and/or to the
operator and/or damage to/failure of the equipment.
DANGER: Contraindications.
Do not use the Piezosurgery on patients with pace-makers or other implantable electronic
devices. The same requirement applies also to the operator.
4 / 32

00.3 - Intended Use

00.4 - Safety requirements

Piezosurgery // GB