mectron Piezosurgery II - Intended Use; Safety Requirements

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Piezosurgery // - manual of use and maintenance
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Piezosurgery // - manual of use and maintenance
00.3 Intended Use
The Piezosurgery is a piezoelectric device for bone surgery that enables osteotomy and osteo-
plasty techniques to be applied to in almost any anatomical situation. This equipment can be used
in the following elds:
- Oral Surgery:
Extraction - Apicectomy - Cystectomy - Osteogenic distraction.
- Implantology:
Bone window osteotomy - Crest expansion - Bone fragment removal - Monocortical bone re-
moval - Osteoplasty - Final preparation of the implant site - Extraction for immediate implanta-
tion - Elevation of Schneider’s membrane.
- Periodontal Surgery:
Osteotomy and osteoplasty techniques - Removal of bone tissues in regeneration surgery -
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 inammable gases (anaesthetic mixtures, oxygen, etc.).
00.4 Safety requirements
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 applica-
ble standards and appropriate requirements.
4 If any assembly operations, extensions, settings, alterations or repairs have been carried 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 specications.
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DANGER: Qualied 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.
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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.
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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.
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DANGER: Contraindications.
An electrosurgical knife could interfere with correct functioning of the device.
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DANGER: Cleaning, disinfection and sterilisation of new or repaired products.
All new or repaired products are delivered in non sterile conditions. Before being used for treat-
ments, all new or repaired products should be cleaned, disinfected and sterilised following the
instructions provided under point “06.0” strictly.
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DANGER: Infection control.
In order to ensure maximum safety for both the patient and the operator, use only accessories that
have been cleaned, disinfected and sterilised. Follow the instructions provided under point “06.0”
closely.
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DANGER: Use only original Mectron accessories and spare parts.
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DANGER: Check the condition of the device before treatment.
Always make sure that there is no water under the apparatus. Before each treatment always check
that the equipment is in proper working order and that the accessories are efcient. Do not carry
out the treatment if any problems are encountered in operating the device. If the problems concern
the equipment contact an authorised technical service centre.
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DANGER: Breakage and wear of the Inserts.
The high-frequency vibrations and wear may, very occasionally, lead to breakage of the insert.
Inserts of which the shape has been changed or which are otherwise damaged are liable to break
during use. Any such inserts should denitely not be used. It is necessary to instruct the patient to
breathe through his nose during the treatment in order to avoid ingestion of the broken off fragment
of the insert.
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DANGER: Do not install the equipment anywhere where there is a risk of explosions.
The equipment cannot function in places where there is an inammable atmosphere (anaesthetic
mixtures, oxygen, etc.).
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DANGER: Personal injury.
The footswitch of the Piezosurgery must not be activated with the door of the peristaltic pump open
(Fig.4 - Ref.B). Moving parts could injure the operator.
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WARNING: Contraindication.
Do not carry out this treatment on metal or ceramic prosthetic artefacts. The ultrasonic vibrations
could lead to decementing of such artefacts.
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WARNING: Contraindication.
After autoclave sterilising of the handpiece, wait for it to cool down completely before using it.