Inspection, Functional Check, Maintenance; Inspection And Functional Check; Sterilization - Kls Martin Group Sonicweld Rx Gebrauchsanweisung

5.4

Inspection, Functional Check, Maintenance

5.4.1

Inspection and Functional Check

Infection or injury may result in the death of the patient or user!
Never use damaged components.
Whether or not the product can be used any further shall be confirmed by successful inspection of the
product. The inspection release and packing into a sterile barrier system releases the product for the next
application.
• The products must be macroscopically clean, i.e., free from visible contamination, after each cleaning
process.
• Inspect the devices for breaks, cracks, deformations, damage and proper functionality.
• Before using the system again and before sterilizing the handpiece, perform a visual inspection and
functional check of all components. The user must particularly look for cable connections and
mechanical damage (breaks, cracks, deformations, damage) on the device and the sonotrode.
5.5

Sterilization

Infection due to non-sterile handling may result in the death of the patient or user!
Improper sterilization and non-sterile handling of the SonicWeld Rx® system and its accessories may result
in serious health risks to the patient.
The warranty for cleaning and sterilization of the handpiece with the connection cable is limited to 250
processing and sterilization cycles. Once the maximum number of cycles has been reached, a notification
appears on the display of the ultrasound device.
The following steam sterilization procedure must be used for sterilization; other sterilization procedures
are not permitted.
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Ultrasonic Unit SonicWeld Rx®
Instructions for Use
Revision 04