Preparation And Installation; General Information; Sterile Operation - Kls Martin Group Sonicweld Rx Gebrauchsanweisung/Technische Beschreibung

Instructions for Use / Technical Description
®
SonicWeld Rx Ultrasonic Unit
2.3

Preparation and Installation

2.3.1

General Information

Gebrüder Martin only guarantees the proper functioning of the device when the following rules
are observed.
When setting-up and operating the unit, the following regulations must be complied with:
National requirements for installation and operation
•
National requirements for fire and explosion prevention
•
The device may only be connected to a grounded outlet with alternating current of
100 – 240 V. Adjustment of the device to different mains voltages is not required.
2.3.2

Sterile Operation

Foot switch and ultrasonic unit must be set up and operated in the unsterile area of the
operation area. Handpiece, hand activation (optional) and connection cable are in the sterile
area of the operating area and must therefore only be used in a sterilised state.
Ensure that the handpiece is dry.
•
Ensure that the handpiece and sonotrode have been sterilised properly, see chapter 3
•
"Reprocessing (Cleaning / Disinfection and Sterilisation)", page 38.
WARNING
Risk of infection due to unsterile use!
Improper sterilisation and unsterile use of the SonicWeld Rx
health risks for the patient.
Sterilisation must be done using a validated steam sterilisation method, e. g. according to
EN 285:2009 in a steriliser and validated according to ISO 17665-1:2006.
V. 2.2
®
system can lead to serious
33