Visual Check For Damage; Sterilisation; Handpiece; Preventive Maintenance - Kls Martin Group Sonicweld Rx Gebrauchsanweisung/Technische Beschreibung

3.2

Visual Check for Damage

Perform a visual check of all components before the system is used again and before the
handpiece is sterilised.
WARNING
Risk of infections and injuries due to damaged components!
Damaged components must not be used!
3.3

Sterilisation

Just like the surgical instruments the sonotrode must be reprocessed. Before use, a new
sonotrode in sterile packing must be used.
3.3.1

Handpiece

WARNING
Risk of infection due to unsterile use!
Improper sterilisation and unsterile use of the SonicWeld Rx
health risks for the patient.
The handpiece can be sterilised with steam.
Sterilisation is to be done using a validated steam sterilisation method, e. g. according
to EN 285:2009 in a steriliser ANSI / AAMI ST46-1993 and validated according to
ISO 17665-1:2006. When using the fractionated vacuum process, sterilisation must be
carried out using the 134 °C / 2 bar programme with a minimum process time of 5 minutes.
We recommend using our storage rack.
NOTICE
The operator / user is responsible for cleaning, disinfecting and sterilising the device. It is
essential that national regulations and restrictions are observed.
3.4

Preventive Maintenance

The ultrasonic device including handpiece and foot switch can be operated without
maintenance.
Safety-related checks are limited to visual checks of the intactness of the connection cable and
the handpiece, the foot switch and the mains connection.
40
Instructions for Use / Technical Description
SonicWeld Rx
®
system can lead to serious
®
Ultrasonic Unit
V. 2.2