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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 and with knowledge of
the Neodent Easy Guide technique. For optimum
results, use the product knowing the appropriate
techniques
and
always
apply
appropriate conditions, in an operating room.
DESCRIPTION
Kit Case for storage of surgical instruments for
use in implant installation procedures using
the Neodent Easy Guide technique. Made of
autoclavable polymer, the case has silicone
supports for safe conditioning and fixation of
each instrument during sanitation, sterilization
and surgical procedures. It has markings and color
identification that organize and guide its use.
The Kit Case can be equipped according to each
procedure.
INDICATIONS FOR USE
Product indicated for conditioning and safe
fastening surgical and/or prosthetic instruments
during their use and sterilization. The use of this
product rationalizes the storage and organization
of instruments during and after the dental
procedure.
APPLICATIONS
The kit is used for the safe storage of surgical
instruments, as well as for support during
sterilization. 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 Technique.
Its
target
population
is
surgeons who perform dental implant installation
procedures.
WARNING
As the clinical outcome of dental treatment is
influenced by multiple variables, the residual
risks described below can occur even if the
product is used according to the instructions for
use. These are: allergy, discomfort, pain, edema,
treatment failure, local infection, inflammation,
local irritation, pyrogenic reaction, loss of
product function, prosthetic and/or aesthetic
and/or biomechanical issues.
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.
KIT CASE ASSEMBLY
To set up this kit case, 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 cassette are sold separately and
must be used according to their own Instructions
for Use.
704021.03
SANITATION
This product must be correctly cleaned after each
use.
Proceed as follows:
Manual cleaning and disinfection
Cleaning
them
under
1. Disassemble
(see specific disassemble instructions for each
instrument, when applicable).
2. Soak the disassembled instruments for at
least 1 min in the cleaning solution (CIDEZYME®,
1.6 % v/v) so that the instruments are sufficiently
covered. Pay attention that there is no contact
between the instruments. Assist cleaning by
careful brushing with a soft brush. Sway movable
parts several times during cleaning.
If applicable, rinse all lumens of the instruments
for, at least, five times using a single-use syringe
(minimum volume of 10 mL).
3. Soak
15 minutes in the cleaning solution (CIDEZYME®,
1.6 % v/v) with ultrasonic treatment so that the
instruments are sufficiently covered. Pay attention
that there is no contact between the instruments.
4. Remove the instruments from the cleaning
solution and intensively post-rinse them for, at
least, 3 times (for the minimum time of 1 minute)
under running water.
If applicable, rinse all lumens of the instruments
for, at least, five times at the beginning of the
soaking time using a single-use syringe (minimum
volume of 10 mL).
Disinfection
1. Soak
12 minutes in the disinfectant solution (CIDEX®
presented
dental
OPA — OPA Solution -, undiluted) so that the
instruments are sufficiently covered. Pay attention
that there is no contact between the instruments.
If applicable, rinse all lumens of the instruments
for, at least, five times at the beginning of the
soaking time using a single-use syringe (minimum
volume of 10 mL).
2. Remove the instruments from the disinfectant
solution and post-rinse them according to the
instructions of tha manufacturer of CIDEX® OPA —
OPA Solution -:
Rinsing Instructions
• Following removal of the instruments from
CIDEX® OPA — OPA Solution — Solution, thoroughly
rinse the medical device by immersing it
completely in a large volume of water. Use
sterile water unless potable water is acceptable
(maximum of 10 microorganisms/mL, maximum of
0.25 endotoxin/mL).
• Keep the device totally immersed for, at least,
1 minute.
• Manually flush all lumens with large volumes
(not less than 100 mL) of rinse water.
• Remove the device and discard the rinse water.
Always use fresh volumes of water for each rinse.
Do not reuse the water for rinsing or any other
purpose.
• Repeat the procedure for 2 additional times,
concluding A TOTAL OF 3 RINSES, with large
volumes of fresh water to remove CIDEX® OPA —
OPA Solution — Solution residues. Residues may
cause serious side effects.
3. Check and pack the instruments immediately
after the removal.
the
instruments
if
the
disassembled
instruments
the
disassembled
instruments
Neodent GM Easy Guide Kit Case Narrow/Regular
Automated cleaning/disinfection
(WD (Washer-Disinfector))
Use neodisher® MediZym.
1. Disassemble
the
(see specific disassemble instructions for each
instrument, when applicable).
2. Transfer the disassembled instruments to the
WD (pay attention that the instruments have no
possible
contact to each other).
3. Start the program.
4. Remove the instruments from the WD after the
end of the program.
5. Check and pack the instruments immediately
after the removal.
NOTE:
1. Pay attention to the following points during the
selection of the WD:
• approved efficiency of the WD (e.g. CE marking
according to EN ISO 15883 or DGHM or FDA
approval/clearance/registration);
for
• possibility of an approved program for thermal
disinfection (A0 value > 3000 or — in case of older
devices — at least 5 minutes at 90 °C/194 °F;
in case of dangerous chemical disinfection of
disinfectant remnants on the instruments);
• use appropriate program for instruments, as well
as sufficient information on rinsing in the program;
• post-rinsing only with sterile or low contaminated
water (e.g. maximum of 10 microorganisms/mL,
maximum of 0.25 endotoxin/mL);
• use only filtered air (oil-free, low contamination
with microorganisms and particles) for drying;
• regular maintenance and check/calibration of
the WD.
2. Please do not clean any instruments by use of
for
using metal brushes or steel wool.
3. Check all instruments after cleaning and
disinfection, on corrosion, damaged surfaces,
and impurities. Do not use damaged instruments.
Instruments that are still contaminated must be
cleaned and disinfected again.
4. Packaging: insert the cleaned and disinfected
instruments on the corresponding sterilization
trays, in single-use sterilization packagings (single or
double packaging) and/or sterilization containers,
which fulfill the following requirements:
• EN ISO/ANSI AAMI ISO 11607 (for USA: FDA
clearance);
• suitable for steam sterilization ;
• sufficient protection for instruments as well as
for maintenance of sterilization packagings against
mechanical damage;
5. After using the instruments, it is recommended
to remove coarse impurities, performing the
pre-treatment, before cleaning and disinfection
(within a maximum deadline of 2 hours).
The pre-treatment step must be performed for
both cases of cleaning and disinfection (automated
and manual).
a. Disassemble the instruments if possible;
b. Rinse the instruments for, at least, 1 minute
under running water (temperature < 35 °C);
c. If applicable, rinse all lumens of the instruments
five times per application using a single-use syringe
(minimum volume of 10 mL). Sway movable parts
several times during pre-treatment;
d. Remove manually all visible impurities by
using a clean and soft brush (or a clean, soft, and
lint-free cloth). In no case use metal brushes or
steel wool;
e. Rinse again for, at least, 1 minute under running
water.
Valid only for Europe
instruments
if
possible
50
50
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