Sterilization For The Us Market; Storage; Troubleshooting - B.Braun Aesculap GB866R Mode D'emploi

Aesculap
ELAN 4 shortening sleeve (1-ring or 2-ring) GB861P to GB863P and lateral burr
guard (1-ring) GB866R

7.11 Sterilization for the US market

■
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
*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.
8.

Troubleshooting

Malfunction
Shortening sleeve cannot be slid onto the shaft
or handpiece from the front.
Shortening sleeve cannot be securely coupled
with the shaft or handpiece.
Shortening sleeve cannot be securely coupled
with the shaft or handpiece.
Lateral burr guard cannot be attached to the
shaft of the handpiece.
Lateral burr guard cannot be locked on the
shaft.
10
®
-6 , Aesculap recommends the
Time Minimum drying time
4 min 20 min
Detection
Shortening sleeve cannot be assem-
bled with manual force.
No clicking in place in the end posi-
tion
Shortening sleeve cannot be gently
slid up and down the shaft.
Lateral burr guard cannot be assem-
bled with manual force.
Lateral burr guard cannot be gently
slid up and down the shaft.

7.12 Storage

►
Store sterile products in germ-proof packaging, protected from dust, in
a dry, dark, temperature-controlled area.
Cause
Shortening sleeve defective
Shortening sleeve defective
Shortening sleeve defective
Lateral burr guard defec-
tive/bent
Lateral burr guard defec-
tive/bent
Remedy
Use a new shortening
sleeve.
Use a new shortening
sleeve.
Use a new shortening
sleeve.
Use a new lateral burr
guard.
Use a new lateral burr
guard.