Intended Use; Safety Requirements - mectron piezo smart Manual Of Use And Maintenance

00.3 Intended use

With the appropriate inserts, the following treatments can be carried out:
- endodontics: reaming of canals;
- scaling to remove plaque and calculus from the surfaces of teeth;
- periodontal treatment for scaling and root-planing without damaging the periodontium;
- retrograde microsurgery for ultrasound treatment of the root apex;
- condensation of amalgam and of gutta-percha;
- removal of bridges and crowns;
- burnishing of fillings.

00.4 Safety Requirements

Mectron cannot accept any liability for direct or incidental damage to property or personal injury 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 in which the equipment is used does not comply with the ap-
plicable standard 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 to not comply with the
requirements indicated in the charter on technical specifications.
� DANGER: Qualified and specialised personnel.
This equipment should be used only by specialised personnel having the appropriate training, The
equipment does not produce any side effects if it is correctly used.
� 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 or failure of the equipment.
� DANGER: Contraindications.
To not use the ultrasonic scaler on patients fitted with pace-makers or other implantable electronic
devices. This warning also applies to the operator.
� DANGER: Cleaning, disinfection and sterilisation of new or repaired products.
All new or repaired products are delivered in non-sterile conditions. All new or repaired products
should therefore be cleaned, disinfected and sterilised before being used for any treatments, fol-
lowing the instructions provided under point "06.0" closely.
� DANGER: Infection control.
In order to censure 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.
� DANGER: Use only original Mectron accessories and spare parts.

piezo smart - manual of use and maintenance
� WARNING: Contraindication.
Do not carry out scaling on metal or ceramic prosthetic artefacts. The ultrasonic vibrations could
cause decementation of the artefacts.
� DANGER: Contraindications.
Do not carry out scaling treatments without spraying water as this could cause overheating of the
insert with consequent injury of the tooth.
The only treatments that can be carried out without spraying water are those envisaged for "Dry
Work" inserts, which are not cannulated.
� DANGER: Check the condition of the device before starting the treatment.
Always make sure that there is no water underneath the device. Before each treatment always
check that the equipment is in proper working order and that the accessories are efficient. Do not
carry out the treatment if any problems are encountered in operating the device. If the problems
concern the equipment contact an authorised Service Centre.
� DANGER: Breakage and wear of the inserts.
In rare cases the high-frequency oscillations and wear can lead to breakage of an insert. Inserts of
which the shape has been altered or that are damaged in any way are liable to break during use.
Any such inserts should not be used under any circumstances. The patient should be instructed to
breathe through his nose during the treatment so as to avoid ingestion of a fragment of a broken
insert.
� DANGER: Do not install the equipment anywhere where there is a risk of explosions.
The equipment must not be used in places where there is an inflammable atmosphere (anaesthetic
mixtures, oxygen, etc.).
piezo smart - manual of use and maintenance