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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 unit
leading to failures of the system, as loss or
fracturing of the implant, loosening or fracturing
704021.03
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 their useful life. Replace the
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
Gravity
for use.
Displacement
• In case there is an accident related to the
1
device, inform the manufacturer using the
communication channels available on the website
15 minutes
and the local competent authorities.
132°C /
ADVERSE EFFECTS
270°F
Adverse effects are not expected as long as the
At least
product is used in accordance with its instructions
20 minutes
2
2
for use.
POST-OPERATIVE PRECAUTIONS AND
MAINTENANCE
The professional in charge is responsible for
providing these guidelines to the patient.
Instruct the patient as to the need for a
professional medical monitoring after the
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
This product must be stored, in its original
packaging, in a clean and dry location, at room
temperature and protected from direct sunlight.
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 product is recommended for up to 60 uses as
long as Neodent recommended conditions of use
are respected. Regardless of the amount of times
the instrument has been used, the professional
must always evaluate its conditions before/after
each use.
Each instrument has its own recommendations of
amount of cycles. Please consult the instructions
for use from the instruments that integrate the
GM Easy Guide Surgical Kit Case Narrow/Regular
Valid for all countries, except Europe and United States
kit and replace them accordingly.
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
Description
Product size
Catalog number
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
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
9
9
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