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2 Safety
2.1 Using the ultrasonic bath
The TRISON ultrasonic bath uses the physical effect of high-performance ultra-
sound in aqueous liquids to clean rinsable and non-rinsable medical instruments.
The TRISON ultrasonic bath is a Class I medical device pursuant to Regulation (EU)
2017/745.
UMDNS nomenclature (ECRI/DIMDI): 14-263
Cleaning is conducted using water and an agent suitable for use with ultrasound.
The use of the TRISON ultrasonic bath is indicated for
• Support for manual pre-cleaning in the context of mechanical reprocessing of
medical devices and as
• Support for manual pre-cleaning and cleaning in the context of manual repro-
cessing of medical devices.
Instruments may not be placed on the bottom of the oscillating tank. They must
be inserted into the sonication fluid with a TRISON Twist, in a TRISON Rack or an
insert basket with basket holder. An overview of suitable accessories can be
found in chapter
.
The TRISON ultrasonic bath may not be operated while unattended.
Intended purpose
The TRISON ultrasonic bath can be used for the following purposes:
Contraindications/exclusions
• Lenses, camera systems, light cables, mirrors, or objects made of or contain-
ing elastic materials (e.g. catheters, respiratory system functional parts, flexi-
ble endoscopes) are not suitable for sonication, or are only suitable under
Purpose (cleaning goal)
Required accessories
Sonication and simultaneous, alternating suction and pressure
rinsing of the instrument shafts while the instrument tools of
the da Vinci Si robotic instruments move
TRISON Twist Si
Right variant or left variant
Sonication and simultaneous, alternating suction and pressure
rinsing of the instrument shafts while the instrument tools of
the da Vinci Xi robotic instruments move
Cleaning of the da Vinci Xi EndoWrist Staplers 45
TRISON Twist Xi
Right variant or left variant
Additional Xi spacer
Sonication and simultaneous suction rinsing of the instrument
shafts of MIS instruments with outer diameters of 3 to 10 mm
TRISON Rack
Right variant or left variant
Sonication of standard instruments
Insert basket and
basket holder
Right variant or left variant
