Sterilization For The Us Market; Storage; Maintenance; Troubleshooting List - B. Braun Aesculap Acculan 4 GA336 Gebrauchsanweisung/Technische Beschreibung

Aesculap
Oscillating saw straight GA336 / Oscillating Sternum saw GA337

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.
9.

Troubleshooting list

►
Have defective products repaired by Aesculap Technical Service, see
Technical Service.
Issue Cause
Product not running No battery
Battery not charged
Battery defective
Product in locked OFF position Safety catch is in OFF position
Product defective
Product becomes too Excessive use
hot
Reprocessing/maintenance
carried out incorrectly
Fall damage, product defec-
tive
Use of a defective attachment Product heating
Blunt tool
12
Acculan 4
®
-6 , Aesculap recommends the
Time Minimum drying time
4 min 20 min
Detection
No battery in the battery shaft
No signal tone when inserting the bat-
tery
No signal tone when inserting the bat-
tery
Product not running
Product heating
Product heating
Product heating
Heating of tool and product

7.12 Storage

►
Store sterile products in germ-proof packaging, protected from dust, in
a dry, dark, temperature-controlled area.
8.

Maintenance

To ensure reliable operation, the product must be maintained in accor-
dance with the maintenance labeling or at least once a year.
YYYY-MM
For technical service, please contact your national B. Braun/Aesculap
agency, see Technical Service.
Remedy
Insert battery.
Charge battery in charger.
Have the manufacturer repair the battery.
Turn the safety catch into the ON position.
Have the manufacturer repair the product.
Follow operating instructions (operating mode).
Follow operating instructions (preparation, care).
Preventative: lubricate product before every ster-
ilization.
Have the manufacturer repair the product.
Have the manufacturer repair the attachment.
Change tool.