MITSUI CHEMICALS KULZER Dispensing gun Mode D'emploi page 10

Program step
Pre-Rinse
Dosage cleaner
Cleaning Deionised water
Rinse Deionised water
Disinfection Deionised water
Drying
Public authorities may adopt other implemented provisions (parameter for disinfection performance) within their field of responsibility.
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3) At the end of the program, remove the instrument.
4) Check for dryness. If it is necessary, wipe with a lint free gauze
and / or dry with medical compressed air (according to the Euro-
pean Pharmacopoeia).
5) After removal from the WD, inspect the instrument (Dispensing
gun) for cleanliness. If debris is still visible, clean the instrument
manually. Afterwards the automated cleaning process must be
carried out again.
Maintenance, Inspection and Testing:
1) All instruments must be visually checked for cleanliness, dryness
and functionality, if necessary, using an illuminated magnifier
(3 – 6 Dptr.)
- Note: Do not use instruments (Dispensing gun) with cracks, fractures,
holes or similar.
Sterilization:
- Equipment: Steam sterilizer according to DIN EN 285 or DIN EN
13060 with type B process
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Water Dosage
Cold
According to manufacturer's
instructions
Time
5 min
10 min
2 min
A0 value >3000
15 min
• Pre-vacuum process, 132°C and sterilization time minimum 3 min
(longer holding times are possible) (132°C, 3 minutes were validated)
1) Place the device in the sterilizer chamber.
2) Start the sterilization program.
3) At the end of the sterilization program remove the device and let it
cool down.
Complaint Notice:
- Please quote batch number and article number in all correspon-
dence about the product.
- Article Number:
- LOT (batch):
Undesired Side Effects and Events:
According to EU Medical Device Regulation users/patients are obliged
to report occurred serious incidents with a medical device to its manu-
facturer and to the competent authority of the country, the incident
occurred.
Temperature
According to manufacturer's
instructions
55°C
(e.g. 5 min, 90°C)
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Uo to 120°C
Dated: 2020-03