Pilot²
4
©
Schlumbohm
GmbH & Co. KG
Intended use
Dental contra-angle for the mechanical preparation of root canals on the patient using
root canal instruments
or root canal instruments with alternating movement.
Improper use may lead to damage of the contra-angle, resulting in and increased risk
and hazard to the patient and third persons.
Qualification of the user
We have based our development and design of the medical device on the dentists target
group.
The medical device must be used in accordance with these Instructions for use.
The medical device has no components that can be repaired by the user.
Skilled application
This medical device is intended solely for use by professionals in dental medicine, in
compliance with the applicable occupational health and safety regulations, safety
precautions, and the present instructions for use. It may only be reprocessed and
maintained by persons having undergone training on the prevention of infections, self-
protection and protection of patients. Improper use, e.g. inadequate hygiene and
improper maintenance, non-observance of the present instructions for use, or the use
of non-authorised accessories and spare parts, shall exempt us from any warranty or
other claims.
Symbols used
Description of the symbols used.
Symbol
Description
The product complies with the requirements of
EU Regulations / No. of notified body
Caution
Indicates
the need for the user to consult the instructions for use for important cautionary information
such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical
device itself. ISO 15223-1:2016 / Ref. 5.5.4 For example: Warning, risk of injuri
Attention!
(to prevent damages occurring)
Thermo washer, disinfectable
Steam sterilization
up to he
stated temperature
General explanations
