Komet EnDrive Gebrauchsanleitung Seite 12

12 | EnDrive - Warnings, precautions, contra-indications, adverse reactions
Sterilizable accessories
• Lip clip, file clamp and contra-angle hand-
piece are supplied non-sterile and must be
sterilised before first use and between
patients.
Repairs and defects
• Check that EnDrive is working properly if it
has been subject to shocks or falls. Do not
use it if there is any malfunction, breakage
or apparent cracks. The safety and effec-
tiveness of the device may be seriously
compromised. In the event of a severe
shock, EnDrive must be inspected by
authorised service.
• EnDrive contains no user-replaceable parts.
Repairs must be carried out by authorised
service. Any unauthorised repair, alteration,
or modification to EnDrive is not permitted
and Nextmed is not responsible for such
modifications.
• It is mandatory to sterilise sterilisable parts
before sending them to a service centre.
• Protect EnDrive with appropriate packaging
before returning it for service.
• Nextmed can provide the information nec-
essary to repair the device to authorised
service centres.
Precautions
• Nextmed disclaims all liability in the event
that EnDrive is used outside of the indica-
tions in this user manual.
• EnDrive may not be able to function cor-
rectly under all conditions, therefore it is
mandatory to take a preoperative radio-
graph before using EnDrive and compare it
with the information provided by the device.
In the event of a clinically relevant discrep-
ancy, it is recommended to take a second
radiograph with the endodontic instrument
positioned at the working length provided
by the device.
Adverse reactions
• If EnDrive provides incorrect readings and
there is no radiographic data for compari-
son, the following adverse reaction may
occur: inadequate root canal treatment due
to over- or under-instrumentation.
• If the file is used contrary to the manufac-
turer's instructions, if it is not new, if the file
in use does not match the one selected on
the screen, the following adverse reaction
may occur: inadequate root canal treatment
due to file breakage within the canal.
Contra-indications
• Do not use the EnDrive apex locator func-
tion on patients with active implantable
devices such as pacemakers, defibrillators,
cochlear implants.
• Use of EnDrive is not recommended on
patients with metal allergies.
• Do not use EnDrive for implantology or any
dental procedure other than endodontics.
• The device is not recommended for use on
people who are colour blind or have hearing
difficulties unless these difficulties are
balanced.