Section A2: Introduction To The Trophon2; A2.1 Indications For Use; A2.2 Disinfection Process; A2.3 Validated Probes, Disinfectants And Chemical Indicators - Nanosonics trophon2 Manual Del Usuario

Protective Wear and Spills
 Wear clean disposable gloves throughout the complete High Level Disinfection (HLD) process
including but not limited to running the trophon2 and handling:
- Disinfectant cartridges. Temporary bleaching and/or irritation of the skin may occur if gloves
are not worn.
- Probes before and after a HLD cycle.
- 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.

SECTION A2: Introduction to the trophon2

A2.1 Indications for Use

The trophon2 is intended for the high level disinfection (HLD) of non-lumened, reusable, transiently
invasive and non-invasive medical instruments/devices e.g. devices that are intended for use for
imaging, diagnostic, ablation, coagulation and their accessories.
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 NanoNebulant", delivered from a multi-dose cartridge.
The trophon2 is suitable for use in general hospital and health care facilities by trained personnel.
The trophon NanoNebulant should be used with the following contact conditions:
Minimum Operational Cycle Time:
Minimum Concentration:
Minimum Disinfectant Dose:
Minimum Chamber Temperature:
The trophon2 is NOT intended to reprocess single-use devices or 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.
The terms "ultrasound probe" and/or "probe" in the User Manual refer to approved medical instruments.
*

A2.2 Disinfection Process

At the start of the HLD cycle, the trophon2 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 for emptying.
The contact conditions are fixed cycle parameters that the end user cannot modify.

A2.3 Validated Probes, Disinfectants and Chemical Indicators.

For details of probes that can be used in the trophon2, refer to the Validated Probe List on the
Nanosonics website.
Use only trophon NanoNebulant disinfectant cartridges and trophon Chemical Indicators when high
level disinfecting with the trophon2. No other disinfectant or chemical indicator has been approved for
use with the trophon2.
L03031 1.0 03/2018
7 minutes
31.5%
1.0 g
56°C
7