1686-000 GB/2021-03
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Safety
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2.2 Use in medical field
The intended medical purpose of the ultrasonic bath is the cleaning
of instruments. Ultrasonic cleaning is performed in the context of
further steps required when reprocessing medical devices. Please
observe the hygiene requirements as per the applicable regulations
during this procedure. The ultrasonic bath is a Class I medical device
according to regulation (EU) 2017/745.
UMDNS nomenclature (ECRI/DIMDI): 14-263
Indications/application areas
Medical instruments can be cleaned in the ultrasonic bath as part of
manual reprocessing as well as before or after machine reprocess-
ing. The instrument manufacturer's specifications provide informa-
tion on suitability for ultrasonic cleaning.
Contraindications/exclusions
• Optical equipment, camera systems, light cables, mirrors or
objects made from or with elastic materials (e.g. catheters, ven-
tilator system parts and flexible endoscopes) are unsuitable or
only conditionally suitable for sonication. The respective manu-
facturer's specifications provide information on suitability for
ultrasonic cleaning.
• The ultrasonic bath is not suitable for the cleaning and disinfec-
tion of contact lenses.
• The direct sonication of inflammable liquids is not permitted.
Possible side effects/restrictions
• Ultrasound does not disinfect. However, processes, e.g. chemi-
cal disinfection, can be accelerated in the ultrasonic bath.
• Surfaces can be mechanically attacked and coatings dissolved
due to cavitation erosion.
