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Processing instructions
ATTENTION! Special Instructions
Please inspect the instrument after manual conditioning to make sure that it is clean. If
you can still see visible impurities, please repeat the above procedures.
Equipment for machine cleaning and disinfection in the WD
(washer-disinfector):
Washer-disinfector:
washer-disinfector in accordance with DIN EN ISO 15883-1/
-2 with thermal programme (temperature 90°C to 95°C)
Cleaner:
mild alkaline cleaner, validated: Ecolab, Sekumatic
MultiClean
Step 3: Machine cleaning and disinfection
Lay or position the individual parts in a suitable mesh tray or rack so all internal and
external surfaces of the instruments can be cleaned and disinfected. Insert instru-
ments with a diameter of 20 cm. The instruments must be attached to the rack (e.g.
MIC device trolley) to ensure that the internal lumens are rinsed.. The attachment
must be checked to ensure that it is tight before starting the machine and at the end of
the process. Close the washer-disinfector and start the programme.
See the table below for the programme:
Programme step
Water
Prewash
CW
1
Cleaner dosage
As per manufac-
turer's directions
Clean
DI
2
Rinse
DI
2
Disinfect
DI
2
Dry
1
CW = cold water
2
DI = deionised water
3
Regulators may specify different processing regulations in their areas of
responsibility (parameters for disinfection performance).
Remove all medical devices at the end of the programme. Check that the load is dry
and if necessary dry the load with medical compressed air. After emptying the WD
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 ®I, oil spray supplied by
B. 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.
Dosage
Time
Temperature
5 min
As per manufac-
turer's directions
10 min
2 min
3 min
A
value> 3000
0
e.g. 90°C, 5 min)
(
15 min
Up to 120°C
Equipment for packaging
Foil-paper packaging:
Sealing unit:
Step 5: Packing
Push the traction cable into the tube until the distal end of the instrument still projects
from the tube. Do not coil the instrument any tighter than a diameter of 20 cm and
place it in the packaging together with the small parts. 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.
Equipment and process for sterilisation:
Steriliser:
Process:
Step 6: Sterilisation
Place the packed devices in the sterilising chamber and start the programme. At the
55°C
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.
3
Step 7: Storage
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
validated: steriCLIN, art. no. 3FKFS23011 and
3FKFS230114
validated: HAWO, type 880 DC-V
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. 5 min (longer retentions times are
possible), (validated 134°C, 5 minutes).
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