Description Of The Appliance; Eligible Patient Group; Patient Selection Criteria; Indications For Use - mectron Compact Piezo LED Installationsanleitung

COMPACT PIEZO LED
WARNING: The appliance must be used
in a dental practice or clinic, or in professional
oral hygiene and preventive care centres. Do
not use the device in environments where
the atmosphere is saturated with flammable
gases (anaesthetic mixtures, oxygen, etc.).
1.2 Description of the Appliance
COMPACT PIEZO LED is a multi-purpose pi-
ezoelectric 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 automat-
1.2.1 Eligible Patient Group
This medical device is designed to be used with the following patient groups:
• Children;
• Adolescents;
• Adults;
• Seniors.
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;
1.2.3 Indications for Use
Use of the device is suitable for all eligible patients (see
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
2
staff.
The appliance is intended exclusively for
use by a dental surgeon, dentist, or dental
hygienist, with suitable medical/health
training.
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.
ic tuning circuit that optimises power and
frequency for each insert available, in order
to always operate in conditions of maximum
efficiency. The handpiece is fitted with a 360°
adjustable LED light and can be autoclaved at
a maximum temperature of 135°C for a maxi-
mum period of 20 minutes.
This medical device can be used on patients of
any age, weight, height, gender, and national-
ity, where applicable.
All piezoelectric ultrasonic scaler device mod-
els are intended for professional use only. The
user is therefore the only person able to de-
cide if and how to treat their patients.
).
WARNING: Qualified and specialised
WARNING: Intended use. Use the
2. Patients with clinical conditions not
suitable for treatment of the sites (for
example: local anaesthesia).
Chapter 1.2.1 on page 2 ) whose