This is a Medical device, or a medical device accessory for professional use by Dentists, assisted by authorised
The device is intended for use on Dental Units complying with the 93/42/EEC Directive and subsequent additions and
amendments, complying with the IEC 60601-1 standard (III ed.) and installed in locations meeting the standards in
force for locations for medical purposes and with an electrical plant system that complies with the IEC 60364-7-710
Before using the device read the instructions in this manual carefully. The use of the device must respect the
For the correct interpretation of the indications in this manual the Italian text is binding.
- The device is not suitable for use with blends of inflammable anaesthetics and oxygen or nitrous oxide.
- The instrument is provided in a non-sterile state. Before use, see to its suitable cleaning and disinfection. If the
device may be sterilised, lubricate it before performing the autoclave sterilisation.
- Use of electrically-powered devices may interfere with the operation of active implantable devices such as
pacemakers or other active devices. In case of doubt regarding the treatment of patients with such devices,
consult a cardiology expert or another competent medical institute.
- During use of the device dust and fragments from the patient’s oral cavity or from the same device may be
projected into the environment (organic and inorganic dust and metal dust, fragments of the device or its tips and
potentially infected biological material).
- Protect the patient, when possible, using a dental dam.