Section A2: Introduction To The Trophon2 Device; A2.1 Indications For Use - Nanosonics trophon 2 Manual Del Usuario

Electrical Device
Use the power cable supplied with the trophon2 device, connect to an earthed power outlet with
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the correct voltage and frequency as specified on the product and in Appendix 1: trophon2 Device
Technical Specifications N05000-2. Incorrect voltage can damage the product.
The trophon2 device must not be connected to the same circuit as critical patient or life support
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equipment.
Spilled fluid can result in electrical shock. Avoid spilling fluids on or around the trophon2 device.
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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.
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Protective Wear and Spills
Wear clean disposable gloves throughout the complete high level disinfection (HLD) process
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including but not limited to operating the trophon2 device and handling:
trophon NanoNebulant. Temporary bleaching and/or irritation of the skin may occur if
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gloves are not worn.
Probes before and after a HLD cycle.
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trophon Chemical Indicators before and after a HLD cycle.
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Waste drawer when emptying or obtaining the Manual Door Lock key.
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Wear appropriate personal protective equipment (PPE) when managing spills.
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• Never return spills to original cartridges for re-use.
Any serious incidents in relation to the trophon2 device or trophon NanoNebulant 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 device 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 system consists of a multiple-use device, combined with a single-use disinfectant "trophon
NanoNebulant", 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 NanoNebulant 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.
* The terms "ultrasound probe" and "probe" in the User Manual refer to approved medical instruments.
7 minutes
31.5%
1.0 g
56 °C
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L03082 1.0 09/2021