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GenENDO K-Files / GenENDO K-Reamers /
GenENDO H-Files
Instructions for use
1. Indication
The medical devices (K-Files, Hedstroem Files, K-Reamers) are used
for catheterisation (n°008 to 015) and root canal shaping (all other
diameters) during a non-surgical endodontic treatment. K-Files 008
and 010 are also used in the exploration, initial penetration and
root canal permeabilisation.
For use by dental professionals only.
2. Contraindications
There is no contraindications to the use for endodontically treating
a tooth by orthograde route.
3. Complications
In cases of complex canal anatomy, per-operative risks
(instrumental breakage, ledge, stripping, zipping, false path,
perforation, etc.) could occur and lead to a risk of infectious
processes.
4. Characteristics and warnings
Maximum recommended number of uses (if the
Ø
le is not visually damaged)
< 020
2
≥ 020
5
• Check the condition of the instrument's blade and its t with the
handle before use. If the instrument is damaged or shows signs
of wear, do not use it.
• Inform the manufacturer and the national regulatory authority
of any serious incident relating to the instrument.
Medical device class according to MDR 2017/745: I.
Packaging
Non-sterile
symbol
5. Clinical claims
There are no speci c clinical claims for the devices other than
the achievement of the indication for use that corresponds to
paragraph 1.
6. Reprocessing instructions
• For all metal devices, the use of anticorrosion
disinfecting
and
cleaning
agents
recommended.
• For your own safety, please wear personal
protective equipment (gloves, glasses and
mask).
• Do not use cleaning or disinfecting agents
containing phenol, aldehyde and alkaline
composition.
• Always respect the instructions for use provided
by the manufacturer of the products.
• Due to the product design and the materials
used, no de nite limit to the maximum
number of performable processing cycles can
be speci ed. The service life of the medical
devices is determined by their function and
careful handling. Multiple use disinfection and
re-sterilisation cycles may lead to increased risk
of le separation.
• The user must ensure that the processing
method used, including re-sources, materials
and personnel, is appropriate and meets the
applica-ble requirements.
• The state of the art and national laws require
that validated procedures be followed.
• Gloves, masks, gown as recommended by the
manufacturer of cleaning agent and detergent
• Tap or deionized water
• Disinfectant (neodisher® Septo Active)
• Detergent (neodisher® MediZym)
• Small soft brushes
• Container
• Ultrasonic tub or washer-disinfector
• Class B sterilisation apparatus
Remark: All material used should be cleaned and
replaced regularly. Identify material used for each
step of the process (initial treatment, cleaning or
rinsing).
Initial treatment
Place used products in a container or a wipe with
tap water at 20-40 °C and 1.0 % neodisher® Septo
Active for 5 to 15 min.
Rinse the products with tap water at 20-40 °C for
1 min.
If there is waiting time before the next step, make
sure the device stays moist by placing it in a wet
1
wipe. Do not exceed 1 hour waiting time.
Remarks:
• Do not use xing agents or hot water (> 40 °C),
as this causes xation of residues and can impair
successful cleaning.
• Follow instructions and respect concentrations
and
immersion
times
speci ed
manufacturer (an excessive concentration may
cause corrosion or other defects on devices).
Preparation before cleaning
If the devices have visible impurities, it is
recommended to manually pre-clean by brushing
under tap water at 20-40°C for at least 1 min with a
2
soft brush until all impurities have been removed.
Remark:
Follow
instructions
and
concentrations and immersion times speci ed by
the manufacturer (an excessive concentration may
cause corrosion or others defects on devices).
Visual inspection
3
Inspect the used products and discard damaged
products (broken, untwisted or abnormally bent).
Cleaning
EN
Insert the products into an ultrasound apparatus
beaker.
Run ultrasound apparatus for 10-30 min with tap
4
water and 0.5-2.0% neodisher® MediZym.
Remarks: Follow instructions, observe water quality,
concentrations and cleaning time speci ed by the
manufacturer of the cleaning solution.
Rinsing
Rinse the products with tap water at 20-40°C for
5
1 min.
Remark: It is recommended to use deionized water.
Drying
6
Dry the products with compressed air until
products are visibly dry.
Cleaning/Rinsing/Drying
Place the instruments in the tray of the washer/
disinfector's sliding trolley.
Perform cleaning cycle with 0.2-1.0% neodisher®
MediZym.
Perform drying.
Remarks:
• Disinfection (thermal or chemical-thermal) is not
4
required since the products are sterilised after
cleaning.
5
• Follow instructions and concentrations speci ed
6
by the manufacturer of the detergent solution.
• Follow the instructions of the washer-disinfector
and verify that the success criteria have been met
after each cycle as speci ed by the manufacturer.
• The nal rinse step should be with deionized
water. For other steps, follow the water quality
de ned by the manufacturer.
• Use only approved washers-disinfectors that
comply with EN ISO 15883, and are maintained
and validated regularly.
Visual inspection
Inspect the used products.
7
Re-do steps 4-5-6 if the product is visibly not clean
or discard any damaged products.
Packaging
Place the instruments in a paper-plastic pouch for
steam sterilisation in compliance with ISO 11607
is
and EN 868 standards.
Remarks:
• For sharp devices that are not contained within
8
a box, silicon tubes should be placed around
the devices to prevent the packaging from being
pierced.
• Seal the pouches as recommended by of the
pouch manufacturer. If a thermo-sealer is used,
the process must be validated and the thermo-
sealer must be calibrated and quali ed.
Sterilisation
Sterilise the products using steam:
• Apparatus: class B
• Minimum temperature: 132°C
• Minimum time: 3 min
• Absolute pressure: 2.2 bar
• Minimum drying: 20 min
Control the physico-chemical indicators and cycle
parameters.
The temperature settings at 134°C and duration of
18 min are mandatory for prion inactivation accor-
9
ding to French regulations.
Remarks:
• When sterilising multiple instruments in one
autoclave cycle, ensure that the steriliser's
maximum load is not exceeded.
• Place the pouches in the steam steriliser
according to the recommendations given by the
steriliser manufacturer.
• Use only a pre-vacuum air removal steam
steriliser that meets the requirements of EN 13060
(class B, small steriliser) and EN 285 (full-size
steriliser), with saturated steam.
Storage
Store the products in a dry, clean and dust-free
environment at the temperature speci ed by
the paper-plastic pouch by the steam steriliser
10
manufacturer.
Remark: Check the packaging and the medical
devices before using them (packaging integrity, no
humidity and use-by date). In case of damage, a
complete rerun should be performed.
7. Storage and transport conditions
None.
8. Disposal
After use, instruments must be placed in a secure container, used to
collect cutting or sticking instruments (like needles or disposable
bistouries) as per good dentistry practices.
by
the
respect
9. Symbols
Stainless
Root canal
steel
preparation
material
Quantity
Sterilizable in a steam
sterilizer (autoclave)
at the temperature
speci ed
K Files
Assortment
K Reamers
Do not use if
packaged is damaged
H Files
Medical device
Year of CE marking: 2020
Date of IFU revision : 2021-05-10
Reference : 30005365-D
Micro-Mega SA
12, rue du Tunnel – 25000 BESANCON – FRANCE
Internet : www.genendo.com
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