Additional Information - FujiFilm medwork LIT2-D-HAN Instructions

Processing instructions
Programme step Water
Prewash CW 1
Cleaner dosage
Clean CW 1
Disinfectant dosage
Disinfect CW
1
Rinse DI²
Dry
1 CW = cold water
2 DI = deionised water
Remove all medical devices at the end of the programme. Check that the load is dry
and if necessary dry the load with a lint-free cloth or medical compressed air. After
emptying the WD-E inspect the load to make sure that it is clean. If contamination is
still visible, steps 2 and 3 of the reprocessing instructions must be repeated.
Equipment for maintenance, inspection and testing
Oil spray: silicone-free, steam-sterilisable oil spray approved for use
with medical devices , e.g. Sterilit
Braun Aesculap
Step 4: Maintenance, inspection and testing
Visually inspect the instrument to check that it is clean, undamaged and functional,
using a lighted magnifier if necessary (3-6 dioptre). Test the function of the instrument
and inspect it for damage and wear. Pay particular attention here to functional
movement and completeness of all components. Where applicable, use suitable oil
spray on pivot points of moving parts.
ATTENTION! Special Instructions
Do not use any products which show kinks, cracks, fractures, discoloration, surface
changes or similar.
Equipment for packaging
Foil-paper packaging: validated: steriClin, art. no. 3FKFS230110 and
3FKFS230112
Sealing unit: validated: HAWO, type 880 DC-V
Step 5: Packing
Assemble the instruments. Follow the instructions for assembly in the applicable
instructions for use. A suitable process (sterile barrier system in accordance with DIN
EN ISO 11607 (single)) must be followed to pack the instrument.
ATTENTION! Special Instructions
The instruments can be packed in packages of one or two instruments. The packages
must be large enough so the sealing seam is not under tension. (In the packaging
process described here two instruments are packed in one foil-paper package.) After
heat-sealing the sealing seam must be visually checked for any faults. If any faults are
found, the package must be opened and the instrument packed and sealed again.
Dosage Time Temperature
1 min
As per As per
manufacturer's manufacturer's
directions directions
5 min
As per As per
manufacturer's manufacturer's
directions directions
5 min
3 min
3 min
® I, oil spray supplied by B.
Equipment and process for sterilisation:
Steriliser:
Process:
55°C
Step 6: Sterilisation
Place the packed devices in the sterilising chamber and start the programme. At the
end of the programme remove the instruments and allow them to cool. Then inspect
the packages for damage and penetration of moisture. Suspect packages must be
evaluated as unsterile. The device must be packed and sterilised again.
55°C
Step 7: Storage
54°C
Storage location (protected from dust and moisture as a minimum) and storage time
with the user according to the specifications.
Reusability
The instruments can be reused ten times assuming appropriate care and that they are
uncontaminated. Any additional reuse or the use of damaged and/or contaminated
instruments is within the responsibility of the operator. No liability will be accepted in
case of misuse.

Additional information:

Further information on conditioning can be found in the internet at:
www.rki.de
www.esgena.org
List of all icons used on FUJIFILM medwork products
steriliser in accordance with DIN EN 285 or small steam
steriliser in accordance with DIN EN 13060, Type B
process
steam sterilisation with fractionated pre-vacuum, 134°C,
retention time min. 3 min or 132°C min. 3 min (longer
retentions times are possible), (validated 132°C, 3 minutes).
Date of manufacture
Follow the instructions
for use
Applied part Type BF
Batch code
Item number
Packaging unit
Do not reuse
Sterilised using
ethylene oxide
Non-sterile
Manufacturer
Sterile barrier system
English
Use by
Caution near pacemakers
Do not use if packaging
is damaged
Not suitable for lithotripsy
Contains natural rubber
latex
Gastroscopy
Colonoscopy
Enteroscopy
ERCP
Medical device