B. Braun Aesculap DAVID 3 PV430 Gebrauchsanweisung Seite 13

6.9 Sterilization
Damage to the camera control unit by sterilization!
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Do not sterilize the camera control unit under
any circumstances.
CAUTION
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Clean the camera control unit by surface disin-
fection only.
Damage to the camera head or the endoscopic lens
caused by inappropriate sterilization processes!
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Never sterilize the camera head or the endo-
CAUTION
scopic lens with steam or in an autoclave.
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Do not carry out chemical sterilization.
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Use Aesculap disposable sterile covers JG904. Follow the instructions
for use of the sterile covers.
The camera head and the endo-lens can be sterilized through the follow-
ing processes. The material will not be adversely affected by these steril-
ization processes, even if sterility is not achieved. It is the responsibility of
the user to decide if this process is effective in achieving the intended
sterilization effect:
■
Sterrad® sterilization process: using Sterrad® sterilizers Sterrad® 50,
Sterrad® 100S, Sterrad® 200
Sterilization through the Sterrad® sterilization process
Note
The Sterrad® sterilization process can cause cosmetic changes to the cam-
era head and cable. These changes do however not affect its functionality.
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Sterilize by the Sterrad® sterilization process Sterrad® 50, Sterrad®
100S, Sterrad® 200, observing the following rules: Follow the Sterrad®
system manufacturer's instructions. Use of a biological indicator is rec-
ommended to confirm effective sterilization. Ensure proper venting of
openings and canals by unscrewing cap 23 from camera plug 21 at
least 5 minutes prior to using the camera.
6.10 Sterilization for the US market
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Aesculap advises against sterilizing the device by flash sterilization or
chemical sterilization.
■
Sterilization may be accomplished by a standard prevacuum cycle in a
steam autoclave.
To achieve a sterility assurance level of 10
following parameters:
Aesculap Orga Tray/Sterile container (perforated bottom)
Minimum cycle parameters*
Sterilization Temp.
method
Prevacuum 270 °F/275 °F
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, Aesculap recommends the
Time Minimum drying time
4 min 20 min
*Aesculap has validated the above sterilization cycle and has the data on
file. The validation was accomplished in an Aesculap sterile container
cleared by FDA for the sterilization and storage of these products. Other
sterilization cycles may also be suitable, however individuals or hospitals
not using the recommended method are advised to validate any alterna-
tive method using appropriate laboratory techniques. Use an FDA cleared
accessory to maintain sterility after processing, such as a wrap, pouch, etc.
6.11 Storage
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Store processed products in germ-proof packaging in a dust-protected,
dry, dark and temperature-controlled room.
7. Maintenance
To ensure reliable operation, Aesculap recommends maintaining the prod-
uct at least once a year.
For technical service, please contact your national B. Braun/Aesculap
agency, see Technical Service.
7.1 Fuse replacement
Risk of fatal injury from electric shock!
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Unplug the device before changing the fuses!
DANGER
Specified fuses: T 0.5 A L/250 V~; art. no. TA020394
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Use a small screwdriver to release the clip on the fuse holder 29.
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Remove fuse holder 29.
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Replace both fuses.
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Reinsert fuse holder 29 so that it audibly snaps into place.
Note
If the fuses burn out frequently, the device is faulty and should be
repaired, see Technical Service.
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