The trophon2 device must not be connected to the same circuit as critical patient or life support
equipment.
Spilled fluid can result in electrical shock. Avoid spilling fluids on or around the trophon2 device.
Do not immerse any parts of the trophon2 device in liquid.
Do not attempt to access the internal mechanics. This may result in electric shock.
Protective Wear and Spills
Wear clean disposable gloves throughout the complete high level disinfection (HLD) process
including but not limited to operating the trophon2 device and handling:
trophon Sonex-HL disinfectant cartridges. Temporary bleaching and/or irritation of the skin
may occur if gloves are not worn.
Probes before and after a HLD cycle.
trophon Chemical Indicators before and after a HLD cycle.
Waste drawer when emptying or obtaining the Manual Door Lock key.
Wear appropriate personal protective equipment (PPE) when managing spills.
Never return spills to original cartridges for re-use.
Any serious incidents in relation to the trophon2 device or trophon Sonex-HL should be reported to
Nanosonics and / or the authority of your member state.
SECTION A2: Introduction to the trophon2 device
A2.1 Indications for Use
The trophon2 is designed to provide High-Level Disinfection (HLD) of validated ultrasound probes. High-
Level Disinfection is achieved by surface exposure to a controlled dose of hydrogen peroxide mist
delivered to a disinfection chamber containing the ultrasound probe.*
The trophon2 system consists of a multiple use instrument combined with a single use disinfectant
"trophon Sonex-HL", delivered from a multi-dose cartridge.
The trophon2 device is suitable for use in general hospital and health care facilities by trained personnel.
The trophon Sonex-HL should be used with the following contact conditions:
Minimum Operational Cycle Time:
Minimum Concentration:
Minimum Disinfectant Dose:
Minimum Chamber Temperature:
The trophon2 device is NOT intended to reprocess single-use probes or instruments, or to pre-clean
medical instruments.
Chemical indicator use is required with every HLD cycle. Only the trophon Chemical Indicator product
is the approved chemical indicator for use with trophon2 device.
A2.2 Disinfection Process
At the start of the HLD cycle, the trophon2 device creates an aerosol of concentrated hydrogen peroxide.
This is distributed over the exposed surface of the probe providing thorough HLD of the probe's shaft
and handle. Once used, the hydrogen peroxide is converted into its constituents; oxygen and water.
During a purge cycle, the converted oxygen is vented into the atmosphere and the water is collected
inside the waste drawer located at the side of the trophon2 device for emptying.
7 minutes
31.5%
1.0 g
56 °C (133°F)
11
L03192 3.0 06/2022