Safety
DocNr.: 03-4655 R03.01 | 22.09.2015 | en-US | Ultrasonic Generator
7
Intended use
2 Safety
2.1 Intended use
The ultrasonic generator is intended solely for use in ultrasonic surgery on humans. In
doing so, the ultrasonic generator temporarily transfers and controls energy to a con-
nected instrument. It also provides an irrigation function.
Only Söring instruments may be connected to the ultrasonic generator. The use of
other instruments is not permitted.
The precise medical purpose is determined by the instrument connected. The ultra-
sonic generator is suitable for the following applications:
Mechanical removal and cutting of bones
Wound debridement and wound cleansing
Removal of fibrin tissue and breaking up biofilms
It is not intended for use directly on the eyes or the central circulatory system.
Any use other than that specified is considered to be improper use.
2.2 Selection and qualification of specialist staff
The ultrasonic generator may only be used by personnel properly instructed in its
handling. The manufacturer, authorized distributor or a person authorized by the op-
erator (and trained by either the manufacturer or an authorized distributor) must pro-
vide instruction in handling the ultrasonic generator with the help of this user
manual.
Only qualified and trained physicians may operate on patients using instruments con-
nected to the ultrasonic generator. Only UAW handpieces may also be used by quali-
fied nursing staff to perform wound debridement or wound cleansing.
Any other intended use – e.g. for operation and reprocessing – is only permitted for
qualified specialists such as operating room personnel and sterilization department
personnel possessing the required education, training or knowledge as well as suffi-
cient experience.
Access to the ultrasonic generator is not permitted to insufficiently qualified person-
nel.
out.fm Seite 7 Dienstag, 22. September 2015 3:24 15
