Nanosonics trophon 2 User manual

L03065 2.0

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ENGLISH

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Read this manual before operating the trophon®2 to determine the correct procedures.
For further information, contact your customer service representative or visit the Nanosonics website.
All technical specifications and system approvals are listed in Appendix 1.
©2018 Nanosonics Limited. All rights reserved.
The content of this manual is correct at the time of product purchase.
trophon®2, NanoNebulant®and Sonex-HL®are registered trademarks of Nanosonics Limited.
AcuTraceTM is a registered trademark of Nanosonics Limited in Australia and other countries.
NanoNebulant is the product name of the trophon2 disinfectant used in all regions where trophon2 is
available for sale, with the exception of US and Canada.
Sonex-HL is the product name of the trophon2 disinfectant in the US and Canada.
Nanosonics’ technologies are protected by a combination of patents, trademarks, and exclusive
proprietary rights: http://www.nanosonics.com.au/nanosonics-patent
Your trophon2 representative is:
Conforming to MDD 93/42/EEC; certified by Notified Body TUV Rheinland
Conforming to RoHS Directive 2011/65/EC
Conforming to WEEE Directive 2012/19/EU under Article 7 Recovery
www.nanosonics.eu ●www.nanosonics.com.au
Attach Business Card or information sticker/stamp here.

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Table of Contents
Part A –WARNINGS, INTRODUCTION AND INSTRUCTIONS ............5
SECTION A1: Important Labels, Symbols and Warnings.........................................................5
A1.1 Labels and Symbols.............................................................................................................5
A1.2: Warnings................................................................................................................................6
SECTION A2: Introduction to the trophon2................................................................................7
A2.1 Indications for Use..................................................................................................................7
A2.2 Disinfection Process...............................................................................................................7
A2.3 Validated Probes, Disinfectants and Chemical Indicators......................................................7
A2.4 Training...................................................................................................................................8
A2.5 Environment and User Profile.................................................................................................8
SECTION A3: Instructions............................................................................................................8
Part B –SET UP......................................................................................9
SECTION B1: trophon2 Overview................................................................................................9
B1.1 trophon2 Features ..................................................................................................................9
B1.2 Cable Tray............................................................................................................................10
SECTION B2: Installation Guide................................................................................................11
B2.1 Positioning your trophon2.....................................................................................................11
B2.2 Powering On.........................................................................................................................12
B2.3 Initial Setup...........................................................................................................................12
B2.4 Warm up Cycle.....................................................................................................................12
B2.5 trophon2 Touch Screen........................................................................................................12
B2.6 Basic Settings.......................................................................................................................12
B2.7 AcuTraceTM ...........................................................................................................................12
B2.8 AcuTraceTM Settings.............................................................................................................14
SECTION B3: trophon AcuTrace PLUS.....................................................................................14
B3.1 Activation..............................................................................................................................14
B3.2 Network Parameters Setup ..................................................................................................14
PART C –OPERATION ........................................................................14
SECTION C1: Loading the Disinfectant Cartridge...................................................................14
SECTION C2: Logging the trophon Chemical Indicators........................................................14
SECTION C3: Routine High Level Disinfection Cycle.............................................................15
C3.1 Preparing the Probe.............................................................................................................15
C3.2 Inserting the Chemical Indicator...........................................................................................15
C3.3 Positioning the Probe...........................................................................................................15
C3.4 Closing the Chamber Door...................................................................................................17
C3.5 Disinfecting the Probe ..........................................................................................................17
C3.6 Removing the Probe.............................................................................................................18
C3.7 Sleep Mode ..........................................................................................................................18
PART D –RECORDS............................................................................18
SECTION D1: Record Options ...................................................................................................18
PART E –MAINTENANCE AND ROUTINE CARE ...............................19
SECTION E1: Preventative Maintenance Service....................................................................19
SECTION E2: Purge Cycle..........................................................................................................19
E2.1 When to Run a Purge Cycle.................................................................................................19
E2.2 How to Initiate a Purge Cycle...............................................................................................20
SECTION E3: Regular Cleaning.................................................................................................20
SECTION E4: Transporting the trophon2.................................................................................20
SECTION E5: Disposal of trophon2 ..........................................................................................20
PART F –TROUBLESHOOTING...........................................................20
SECTION F1: Incomplete or Failed Cycles...............................................................................20

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F1.1 Mains Power Failure.............................................................................................................20
F1.2 Cycle Fault............................................................................................................................21
SECTION F2: Manual Door Lock Override................................................................................21
SECTION F3: Diagnostics ..........................................................................................................22
PART G –SERVICE REQUIREMENT AND WARRANTY PROVISION
...............................................................................................................24
APPENDIX 1: TROPHON2 TECHNICAL SPECIFICATIONS N05000-2
...............................................................................................................24
APPENDIX 2: PRODUCT WARRANTY TERMS AND CONDITIONS..25
APPENDIX 3: MicroDoc LICENCE AGREEMENT ..............................26
APPENDIX 4: TROPHON2 ACCESSORIES*.......................................27
GLOSSARY...........................................................................................28

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Part A –WARNINGS, INTRODUCTION AND INSTRUCTIONS
SECTION A1: Important Labels, Symbols and Warnings
A1.1 Labels and Symbols
Caution
Warning
Consult instructions for use
Corrosive
Environmental Conditions:
trophon2 Storage and
Transport Conditions:
Temperature range: -20oC to
+60oC / -4oF to +140oF
Single Use Only
Fragile / Handle With Care
UN 2014 –Hydrogen
Peroxide
Do not disassemble
Dangerous Voltage
Separate collection for
electrical and electronic
equipment
Keep Dry
Keep Out of Direct Sunlight
This Way Up
Batch Number
Product Number
Serial Number
Expires
(year and month)
Legal Manufacturer
Date of Manufacture
Oxidizer –5.1
Corrosive –8
Warning: Hot Surface
Warning: Moving parts, do
not touch mechanism
Cannot be transported by air
freight
Wear Gloves

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Environmental Conditions:
trophon2 Operating
temperature range: 17oC to
27oC / 62.6oF to 80.6oF
AcuTraceTM RFID Zone
Start Up from sleep
Cycle Start
Menu
Integrated Probe Positioning Guide
A1.2: Warnings
Hot Temperatures
Do NOT touch surfaces in the internal chamber. They can be hot and cause burns.
To avoid probe damage, ensure the probe is correctly positioned in the chamber. (See section
C3.3 for correct positioning of probe.)
Malfunctions
Do NOT attempt to open the chamber door during a cycle, power failure or system malfunction.
All repairs must be carried out by trained personnel.
Transporting the trophon2
Follow your facilities manual handling procedures for guidance on lifting heavy
objects.
The trophon2 weighs approximately:
Unpackaged 22kg (48.5lb).
Packaged 25kg (55lb).
If your trophon2 has been used, purge the trophon2 before transportation to remove the
disinfectant. (See section E2).
Electrical Device
Use the power cable supplied with the trophon2, connect to an earthed power outlet with the
correct voltage and frequency as specified on the product and in Appendix 1. Incorrect voltage
can damage the product.
The trophon2 must not be connected to the same circuit as a critical patient or life support device.
Spilled fluid can result in electrical shock. Avoid spilling fluids on or around the trophon2. Do not
immerse any parts of the trophon2 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
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: 7 minutes
Minimum Concentration: 31.5%
Minimum Disinfectant Dose: 1.0 g
Minimum Chamber Temperature: 56°C
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.

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A2.4 Training
Before setting up or using your trophon2, ensure that all users are trained in safety procedures and
potential hazards, as outlined in this manual.
Visit www.nanosonicsacademy.com to complete the online training module.
A2.5 Environment and User Profile
The trophon2 is designed for use in healthcare facilities to high level disinfect ultrasound probes under
the control of trained healthcare professionals.
The disinfection cartridge, Chemical Indicator, and trophon2 system are designed to be used with
minimal personal protective equipment (gloves only) and in a standard workplace or clinical setting,
including at the patient point-of-care. Special ventilation and other safety precautions are not required
when used as per these instructions.
SECTION A3: Instructions
Read these instructions before using the trophon2:
Safety Data Sheet (SDS) enclosed with the trophon2.
Occupational or Workplace Health and Safety Guidelines (OH&SG, OSHA, WHS) for your
institution for lifting, spills etc.
trophon Chemical Indicator Instructions for Use (IFU).
trophon disinfectant cartridge IFU.
trophon accessory IFUs for any additional accessories purchased with the trophon2 (see
Appendix 4).
Probe manufacturer’s instructions.
Failure to follow instructions may result in:
Burns, bleaching, electric shock or other injury.
High level disinfection not achieved.
Residual disinfectant remaining on the probe, which may cause injury when removing.
Equipment damage.