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6. If the cleaning/disinfection products mentioned
cannot be found, make sure to use similar products
to those indicated. Replacement is the owner's
responsibility.
7. The drying of the parts is of utmost importance
before storage and sterilization, because the
accumulation of moisture on the products is
harmful and may cause oxidation.
NOTE: During cleaning, try to avoid contact
between cutting tools and other tools so the
cutting power is not harmed.
PRESENTATION AND STERILIZATION
For traceability, each kit case presents on its tray
the laser engraving of the UDI code (Unique Device
Identification).
This product is reusable and supplied non-sterile,
being unitarily packaged. This product must be
correctly cleaned and sterilized before each use.
Sterilize the products on the previous day or on
the day of the procedure. ATTENTION: This product
cannot be autoclaved in its original packaging.
Please use for sterilization only the steam
sterilization according to the following parameters:
Fractionated
Vacuum / Dynamic
Air Removal
Sterilization
4 minutes
Time
Sterilization
132°C / 270°F
Temperature
At least
Drying Time
20 minutes
1 At least three vacuum steps.
2 The effectiveness required in drying time depends
directly on the parameters of sole responsibility
of the user (density and load configuration,
sterilizing conditions, which must be determined
by the user). Nevertheless, a drying time shorter
than 20 minutes cannot be applied.
NOTE: After sterilization, pack the instruments at
a dry and dust-free place.
PRECAUTIONS
• In case the user has any type of color blindness or
presents any difficulties in differentiating colors,
it is recommended to use the laser markings for
identification.
• This product must be used sterile. Do not
sterilize under dry heat (oven).
• The Kit Case cannot touch the walls of the
autoclave, so its melting is avoided.
• Chemical sterilization is not recommended.
• Place the water measure for the autoclave as
recommended by the manufacturer. Lack of water
during the sterilization cycle may compromise the
effectiveness of the autoclave and melt the tray,
as well as damage the instruments.
• The contact between the tray and acrylic resin
liquid results in damage to the structure of the Kit
Case polymer.
• Be aware in cases of patients that present signs
of allergy or hypersensitivity to chemical elements
of the materials: polymer.
• For sterilization, the instruments and the Kit
Case must be cleaned individually, according to
their own instructions and accommodated in the
Kit Case tray, which must be wrapped in surgical
paper for autoclaving.
• Inappropriate planning can compromise the
performance
of
the
implant/prosthesis
leading to failures of the system, as loss or
704021.03
fracturing of the implant, loosening or fracturing
of the prosthetic screws.
• Do not use the product if its packaging is
damaged.
• Do not use the product with its validity expired.
• Make sure you have all the instruments needed
to perform the procedure according to the surgical
planning.
• Make sure to use the indicated drilling sequence
according to the instructions for use of the planned
implant.
• Before each procedure, make sure the pieces
are properly seated.
• Before each procedure, check the conditions
of the Neodent surgical instruments, always
respecting
instruments if there is damage, deleted markings,
deformation or wear.
• Always use the Neodent product sequence. The
use of prosthetic abutments and/or instruments
from other manufacturers does not ensure the
perfect function of the Neodent Implant System
and exempts any product warranty.
• It is the professional's responsibility to use the
Neodent products according to the instructions for
use.
Gravity
ADVERSE EFFECTS
Displacement
1
Even if the product is used according to the
instructions for use, the residual risks described
15 minutes
under "Warning" can occur.
132°C / 270°F
POST-OPERATIVE PRECAUTIONS
AND MAINTENANCE
At least
20 minutes
The professional in charge is responsible for
2
2
providing these guidelines to the patient.
Instruct the patient as to the need for a
professional
surgery and to obey the guidelines regarding
the precautions, hygiene and prescription of
drugs. Evaluate the need for follow-up with
periodic clinical appointments and radiographic
examinations.
STORAGE CONDITIONS
Until its first use, the product must be stored in
its original packaging, in a clean and dry place,
at room temperature and protected from direct
sunlight. For the storage of reusable items
after the first use, follow the guidelines in the
"Sanitation" and "Presentation and Sterilization"
sections of these instructions for use.
DISPOSAL OF MATERIAL
All products and consumables used during the
surgery for the installation of dental implants may
endanger the health of anyone who handles them.
Before discarding them into the environment, it is
recommended to observe the current legislation
and adhere to it. In case there is no current
legislation, pack them in sharps collector and
dispose them in medical waste.
DATE OF EXPIRATION
Written on the label.
LIFE CYCLE
This case is recommended for up to 60 uses, as
long as the conditions of use recommended by
Neodent are observed. Regardless of how many
times the instruments have been used, the
professional should always assess the condition of
the instruments before and after each use.
Each instrument has its own recommended
unit
number of uses. Please refer to the instructions
their
useful
life.
Replace
medical
monitoring
after
Neodent GM Easy Guide Kit Case Narrow/Regular
for use of the instruments that make up the case
and replace them according to the guidelines.
SYMBOLS
The table describes the symbols that may be
printed on the product labeling. Please, refer to
the physical labeling to see which symbols are
applicable to the product.
Symbols
Product size
Catalog number
the
Batch code
Serial number
Product manufacturing material
UDI code
Medical device
Date of manufacture
Manufacturer
Use-by date
Quantity
Consult instructions for use
Reprocessing forbidden
the
Sterilized using ethylene oxide
Sterilized using irradiation
Do not reuse
Do not use if package is damaged
Do not resterilize
Fragile
Upper limit of temperature
Keep dry
Keep away from sunlight
Authorized representative in the
European Community
Importer in the European Community
Swiss Authorised Representative
Single sterile barrier system
Single sterile barrier system with
protective packaging inside
Notification required by FDA for
United States market
CE Mark
Valid only for Europe
Description
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