Thomas K-File Gebrauchsanweisung Seite 7

PACKAGING
BEFORE USE
USAGE
PRODUCT LIFETIME
STORAGE
DISPOSAL
TRACEABILITY
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INSTRUCTION MANUAL
HAND-HELD INSTRUMENTS FOR ROOT CANAL TREATMENT
Quantity per pack: 6 or 4 units, identical or different (assortment). Plastic packaging.
11. The products supplied are non-sterile. It is essential to follow the steps of cleaning, disinfecting and
sterilising before first use or reuse (see our recommendations on the label on the outer packaging
and those indicated in our current sterilisation cleaning protocol), in accordance with current ISO
17664 standard.
12. Remove damaged or poorly performing products.
13. The responsibility for the sterilisation of products prior to first use and reuse lies with the user.
14. For your safety, we recommend the use of PPE (Personal Protective Equipment) - for example:
gloves, eye protection.
15. Only use disinfectants with proven efficiency (EU labelling, FDA approved, DGHM / VAH list ...)
including the one in our current sterilisation cleaning protocol and follow it.
16. Clean, disinfect, rinse and dry devices with a washer-disinfector. (Ensure compliance according to
the current EN ISO 15833-1 standard and follow the manufacturer's instruction manual).
17. After drying, place the devices in pouches for sterilisation. (Ensure compliance with the current EN
ISO 11607-1 standard) .
18. Sterilise according to the prion program (134°C for 18 minutes) in an autoclave. (Ensure compliance
according to the current standard NF EN 13060 + A1 and follow the manufacturer's instruction
manual).
19. When sterilising multiple devices during a single autoclave cycle, be sure not to exceed its maximum
load. Avoid sterilising devices of different material in the same load.
20. Keep sterilised devices in a cool, clean, dry place.
8. It is essential to follow the cleaning, disinfecting and sterilising stages before first use or reuse (see
our recommendations in our current sterilisation cleaning protocol).
9. Products intended for use by dentists only.
10. Study x-ray images from different angles to determine the width, length and curvature of the root
canal.
11. Depending on the intended use, select the most appropriate endodontic instruments (type and ISO
coding) for shaping, widening, cleaning and filling dental root canals.
12. Before using the instruments, make sure there is no damage, deformation, rust, and scratches.
Irrigate with a solution of sodium hypochlorite (2.5%) and introduce the endodontic instruments by
applying vertical and back-and-forth movements in the root canal. Perform the final rinse with EDTA
solution and then with hypochlorite and dry.
13. The rigidity of endodontic manual steel files allows you to deal with blockages and calcifications.
14. Use these products carefully, to avoid needle stick injury.
The product lifetime is estimated at 3 years from the date of manufacture but may vary depending on the
method of use (cutting, conditions), the frequency of use, or when the sterilisation has reached a maximum of
10 cycles.
No specific requirement, the materials used being Stainless Steel or Titanium Nickel. Nevertheless, it is best
to store the instruments in their original packaging before first use in a clean, dry, moisture-free place and
apply the "first in / first out" management method.
Used instruments must be disposed of in accordance with current regulations, following a protocol for cross-
infection control
For patient safety, it is the responsibility of the healthcare professional to keep the reference and batch number
of the devices used. This information is given on the labels affixed to the packaging of THOMAS products.
We advise against using a THOMAS product whose label is illegible.
Translated from French to English
3rd edition : 01/10/2019