mectron MICROPIEZO, Руководство по эксплуатации и обслуживанию

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MICROPIEZO
WARNING : Intended use .
Use the appliance exclusively for the use for
which it is intended. Failure to observe this
regulation can cause serious injury to the
patient, the operator and damage/faults on
the device.
1.2 Description of the Appliance
MICROPIEZO is a multi-purpose piezoelectric
ultrasonic scaler designed to equip the
operator with a product featuring an
innovative design and unique technical
characteristics, and to ensure patient comfort
during treatment.
The user interface is optimised to make
all functions immediately available, by
integrating them into the touch keyboard. The
handpiece is equipped with a circular LED light
and is autoclavable at 135°C. The appliance
is equipped with an automatic tuning circuit
that optimises power and frequency for each
insert available, in order to always operate in
conditions of maximum efficiency.
1.2.1 Eligible Patient Group
This medical device is designed to be used with the following patient groups:
• Children;
• Adolescents;
• Adults;
• Seniors. This medical device can be used on patients
of any age, weight, height, gender, and
nationality, where applicable.
1.2.2 Patient Selection Criteria
It is not recommended to use the device in the following cases:
1. Patients with active implantable
medical devices (for example:
pacemakers, hearing aids, and/or other
electromagnetic prostheses) without
prior authorisation from their doctor;
2. Patients with clinical conditions not
suitable for treatment of the sites (for
example: local anaesthesia).
All piezoelectric ultrasonic scaler device
models are intended for professional use only.
The user is therefore the only person able to
decide if and how to treat their patients.
1.2.3 Indications for Use
Use of the device is suitable for all eligible patients (see Chapter 1.2.1 on page 2 ) whose
doctor has prescribed professional scaling, periodontology, endodontic cleaning, implant site
surface cleaning, a restorative or prosthetic technique, as part of the intended use of the device
(see Chapter 1.1 on page 1 ).
1.2.4 Users
The device must be used exclusively by specialised and properly trained personnel, specifically
the dental surgeon/dentist or dental hygienist, who must be able-bodied, adult, of any weight,
age, height, gender, and nationality.