1
MEANING OF SYMBOLS
I.
DANGER
MD
Medical device (contra-
angle, handpiece, …)
Visual inspection
Wear gloves
General information
Device reference /
Part number
Non sterile device
Device serial number
Thermo-disinfectable
Date of manufacture
Sterilizable up to 135°C
Name of manufacturer
SCOPE OF USE
II.
Endodontic dental treatments (cleaning, preparation
and filling of the canal). Inappropriate or indirect use
could damage this device and be a risk to the user and
third parties. These
MDs
are for professional use only
in the dental surgery field, and it is recommended the
clinician practice use of the device on extracted teeth
or equivalent prior to use on a live patient. According
to these instruct
ions, the
MD
must only be used by a user with
dental medicine experience, for the stated use, and
in compliance with current guidelines regarding the
prevention of accidents at work, work protection and
the instructions in this leaflet.
MDs
must be prepared
and maintained only by individuals who have been
trained in preventing infections, auto-protection and
patient protection.
According to these instructions, users must:
- Only use non-defective work instruments,
- Only use the
MD
in a unit that complies with the
guidelines of the EN 60601 standard,
- Follow the correct use instructions,
- Protect oneself, patients and third parties against
all dangers,
- Avoid all contamination by the product.
The following situations relieve SybronEndo of all warranty
obligations or other claims.
- Inappropriate use
- Lack of maintenance
- Use of removable accessories or parts not
approved by SybronEndo
- Using accessories from other devices on this
MD
- Change or addition to a
MD
not validated by
SybronEndo
These
MDs
comply with the Community Directive 93/42/
CEE as amended by the 2007/47/CE directive.
GENERAL SAFETY INFORMATION
III.
Prior to use, check that the device has not been
damaged in any way and no parts are missing.
Wear appropriate protection, especially gloves, a mask
and glasses.
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