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The instruments that integrate the kit are sold
separately.
This device is intended for a specialized
procedure, which must be performed by
professionals qualified in Dental Implants, with
knowledge of the Neodent Easy Guide technique.
For optimum results, use the product knowing the
appropriate techniques and always apply them
under appropriate conditions, including in an
operating room.
DESCRIPTION
GM Easy Guide Surgical Kit Case Narrow/Regular
are containers for storage of surgical instruments
during their use, cleaning, and sterilization. It
is manufactured in autoclavable polymer and
enables the storage and safe fastening of each
instrument. The Kit presents markings and
color identification that guide the use of the
instruments during the procedure.
The kit may be equipped according to each
procedure.
INDICATIONS FOR USE
Neodent Instrument Kits are intended to be used
to enclose other medical devices that are to be
sterilized by a health care provider. Neodent
Instrument Kits are intended to allow sterilization
of the enclosed medical devices. Neodent
Instrument Kits require the use of FDA-cleared
wrap to maintain the sterility of the enclosed
devices.
The kits are to be enclosed in a sterilization wrap
that is FDA-cleared for the indicated cycles, and
moist heat (steam) sterilized using one of the
following cycles:
Fractionated vacuum (pre-vacuum) — Exposure at
132 °C for 4 minutes, 20-minute dry time
Gravity displacement — Exposure at 132 °C for
15 minutes, 20-minute dry time.
Neodent Instrument Kits are intended for
sterilization of non-porous loads.
The combined weight of the GM Easy Guide
Surgical Kit Case Narrow/Regular and the
associated instruments is 310,18 g. The weight of
the empty Kit Case is 263,63 g.
Neodent Instrument Kit Cases should not be
stacked during sterilization.
APPLICATIONS
The GM Easy Guide Surgical Kit Case Narrow/
Regular is suitable for safe storage of surgical
instruments, organizing the instruments in the
sequence in which they will be used, as well as
for sterilization of such instruments.
The GM Easy Guide Surgical Kit Case Narrow/
Regular is recommended for the installation of GM
implants with diameters 3.5 and 3.75, using the
Neodent Easy Guide surgical technique.
CONTRAINDICATIONS
This product presents no contraindications as long
as it is used according to its instructions for use.
Limitations of use for each instrument must be
observed in its corresponding instruction for use.
HANDLING
Remove the lid to access the instruments by
gently pressing on the latch system between the
case bottom and the lid. To close the Kit Case,
place the lid on the case bottom and press it
down. During the surgical procedure, the tray
must be placed on a sterile surface and handled
with a sterile glove.
704021.03
KIT CASE ASSEMBLY
To set up this kit, each reserved space is related
to a number from the instrument table; refer to
image of the tray layout. The instruments that go
in the tray are sold separately and must be used
according to their own Instructions for Use.
The maximum load configuration is shown in
Table 1. The combined weight of the GM Easy
Guide Surgical Kit Case Narrow/Regular and the
associated instruments is 310,18 g. The weight of
the empty Kit Case is 263,63 g.
CLEANING
Clean this product according to the following
instructions after each use:
1. Remove the instruments from the Kit Case
and clean separately (see specific instrument
instructions).
2. Disassemble the three parts of the Kit Case.
Soak the lid, tray and base for at least 1 min
in the cleaning solution (Enzol® enzymatic
detergent, prepared per manufacturer directions)
so that the components are sufficiently covered.
Pay attention that there is no contact between
the components. Assist cleaning by careful
brushing with a soft brush, paying particular
attention to the interface between the silicone
block inserts and the tray or base. Do not use
metal brushes or steel wool.
3. Soak the lid, tray and base for 15 min in the
cleaning solution (Enzol® enzymatic detergent,
prepared per manufacturer directions) with
ultrasonic treatment so that the components are
sufficiently covered. Pay attention that there is
no contact between the components.
4. Remove the Kit Case components from the
cleaning solution and rinse them at least 3 times
intensively (at least 1 min) under running water
(local potable water is sufficient).
5. Repeat the cleaning steps of components that
remain visibly contaminated.
6. Check all components after cleaning for signs
of corrosion or damage. Do not continue to use
corroded or damaged components.
7. Dry the components thoroughly before
storage and sterilization; the accumulation of
moisture on the components and instruments may
cause corrosion that can detrimentally affect
instrument performance.
8. Insert the cleaned, disinfected and dried
instruments in the corresponding locations of the
Case Kit tray and base. Assemble the Kit Case
by inserting the tray into the base and attaching
the lid.
9. Protect the assembled Kit Case from moisture
and dust if it will not be used for an extended
time.
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:
GM Easy Guide Surgical Kit Case Narrow/Regular
Fractionated
Vacuum / Dynamic
Air Removal
1
Sterilization
4 minutes
Time
Sterilization
132°C
Temperature
Drying Time
20 minutes
2
At least three vacuum steps
1
The effectiveness required in drying time
2
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.
• 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 sterilizable wrap that is FDA-cleared for the
indicated cycles.
• 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
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.
• 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
for use, and to determine whether it suits the
individual situation of each patient.
Valid for the USA
Gravity
Displacement
15 minutes
132°C
20 minutes
2
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