mectron compact piezo P2K, Use And Maintenance Manual

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2
COMPACT PIEZO P2K
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/failure of the device.
1.2 Description of the Appliance
COMPACT PIEZO P2K is a multi-purpose
piezoelectric ultrasonic scaler.
It is designed to equip the operator with a
product featuring an innovative design and
unique technical characteristics, and to ensure
utmost patient comfort during treatment
thanks to a broad scale of available power
levels.
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 ).