Transcription

L03065 2.0

ENGLISHL03065 2.0 9/20191

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 isavailable 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 exclusiveproprietary rights: http://www.nanosonics.com.au/nanosonics-patentYour trophon2 representative is:Attach Business Card or information sticker/stamp here.Conforming to MDD 93/42/EEC; certified by Notified Body TUV RheinlandConforming to RoHS Directive 2011/65/ECConforming to WEEE Directive 2012/19/EU under Article 7 Recoverywww.nanosonics.euL03065 2.0 9/2019 www.nanosonics.com.au2

Table of ContentsPart A – WARNINGS, INTRODUCTION AND INSTRUCTIONS .5SECTION A1: Important Labels, Symbols and Warnings . 5A1.1 Labels and Symbols . 5A1.2: Warnings . 6SECTION A2: Introduction to the trophon2 . 7A2.1 Indications for Use . 7A2.2 Disinfection Process . 7A2.3 Validated Probes, Disinfectants and Chemical Indicators. . 7A2.4 Training . 8A2.5 Environment and User Profile. 8SECTION A3: Instructions . 8Part B – SET UP.9SECTION B1: trophon2 Overview . 9B1.1 trophon2 Features . 9B1.2 Cable Tray . 10SECTION B2: Installation Guide . 11B2.1 Positioning your trophon2 . 11B2.2 Powering On . 12B2.3 Initial Setup . 12B2.4 Warm up Cycle . 12B2.5 trophon2 Touch Screen . 12B2.6 Basic Settings . 12B2.7 AcuTraceTM . 12B2.8 AcuTraceTM Settings . 14SECTION B3: trophon AcuTrace PLUS. 14B3.1 Activation . 14B3.2 Network Parameters Setup . 14PART C – OPERATION .14SECTION C1: Loading the Disinfectant Cartridge . 14SECTION C2: Logging the trophon Chemical Indicators . 14SECTION C3: Routine High Level Disinfection Cycle . 15C3.1 Preparing the Probe . 15C3.2 Inserting the Chemical Indicator . 15C3.3 Positioning the Probe . 15C3.4 Closing the Chamber Door . 17C3.5 Disinfecting the Probe . 17C3.6 Removing the Probe . 18C3.7 Sleep Mode . 18PART D – RECORDS .18SECTION D1: Record Options . 18PART E –MAINTENANCE AND ROUTINE CARE .19SECTION E1: Preventative Maintenance Service . 19SECTION E2: Purge Cycle . 19E2.1 When to Run a Purge Cycle . 19E2.2 How to Initiate a Purge Cycle . 20SECTION E3: Regular Cleaning . 20SECTION E4: Transporting the trophon2 . 20SECTION E5: Disposal of trophon2 . 20PART F –TROUBLESHOOTING .20SECTION F1: Incomplete or Failed Cycles . 20L03065 2.0 9/20193

F1.1 Mains Power Failure . 20F1.2 Cycle Fault . 21SECTION F2: Manual Door Lock Override. 21SECTION F3: Diagnostics . 22PART G – SERVICE REQUIREMENT AND WARRANTY PROVISION.24APPENDIX 1: TROPHON2 TECHNICAL SPECIFICATIONS N05000-2.24APPENDIX 2: PRODUCT WARRANTY TERMS AND CONDITIONS .25APPENDIX 3: MicroDoc LICENCE AGREEMENT .26APPENDIX 4: TROPHON2 ACCESSORIES* .27GLOSSARY .28L03065 2.0 9/20194

Part A – WARNINGS, INTRODUCTION AND INSTRUCTIONSSECTION A1: Important Labels, Symbols and WarningsA1.1 Labels and SymbolsL03065 2.0 9/2019CautionWarningConsult instructions for useCorrosiveEnvironmental Conditions:trophon2 Storage andTransport Conditions:Temperature range: -20oC to 60oC / -4oF to 140oFSingle Use OnlyFragile / Handle With CareUN 2014 – HydrogenPeroxideDo not disassembleDangerous VoltageSeparate collection forelectrical and electronicequipmentKeep DryKeep Out of Direct SunlightThis Way UpBatch NumberProduct NumberSerial NumberExpires(year and month)Legal ManufacturerDate of ManufactureOxidizer – 5.1Corrosive – 8Warning: Hot SurfaceWarning: Moving parts, donot touch mechanismCannot be transported by airfreightWear Gloves5

Environmental Conditions:trophon2 Operatingtemperature range: 17oC to27oC / 62.6oF to 80.6oFAcuTraceTM RFID ZoneStart Up from sleepCycle StartMenuIntegrated Probe Positioning GuideA1.2: WarningsHot 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 sectionC3.3 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 trophon2Follow your facilities manual handling procedures for guidance on lifting heavyobjects. The trophon2 weighs approximately:Unpackaged 22kg (48.5lb).Packaged 25kg (55lb). If your trophon2 has been used, purge the trophon2 before transportation to remove thedisinfectant. (See section E2).Electrical Device Use the power cable supplied with the trophon2, connect to an earthed power outlet with thecorrect voltage and frequency as specified on the product and in Appendix 1. Incorrect voltagecan 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 notimmerse any parts of the trophon2 in liquid. Do not attempt to access the internal mechanics. This may result in electric shock.L03065 2.0 9/20196

Protective Wear and Spills Wear clean disposable gloves throughout the complete High Level Disinfection (HLD) processincluding but not limited to running the trophon2 and handling:-Disinfectant cartridges. Temporary bleaching and/or irritation of the skin may occur if glovesare 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 trophon2A2.1 Indications for UseThe trophon2 is intended for the high level disinfection (HLD) of non-lumened, reusable, transientlyinvasive and non-invasive medical instruments/devices e.g. devices that are intended for use forimaging, 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 peroxidemist 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 minutesMinimum Concentration:31.5%Minimum Disinfectant Dose:1.0 gMinimum Chamber Temperature:56 CThe 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 productis 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 ProcessAt the start of the HLD cycle, the trophon2 creates an aerosol of concentrated hydrogen peroxide. Thisis distributed over the exposed surface of the probe providing thorough HLD of the probe’s shaft andhandle. Once used, the hydrogen peroxide is converted into its constituents; oxygen and water. Duringa purge cycle, the converted oxygen is vented into the atmosphere and the water is collected inside thewaste 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 theNanosonics website.Use only trophon NanoNebulant disinfectant cartridges and trophon Chemical Indicators when highlevel disinfecting with the trophon2. No other disinfectant or chemical indicator has been approved foruse with the trophon2.L03065 2.0 9/20197

A2.4 TrainingBefore setting up or using your trophon2, ensure that all users are trained in safety procedures andpotential hazards, as outlined in this manual.Visit www.nanosonicsacademy.com to complete the online training module.A2.5 Environment and User ProfileThe trophon2 is designed for use in healthcare facilities to high level disinfect ultrasound probes underthe control of trained healthcare professionals.The disinfection cartridge, Chemical Indicator, and trophon2 system are designed to be used withminimal 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 requiredwhen used as per these instructions.SECTION A3: InstructionsRead 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 yourinstitution 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 (seeAppendix 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.L03065 2.0 9/20198

Part B – SET UPSECTION B1: trophon2 OverviewB1.1 trophon2 FeaturesFrontBack123Figure 1Figure 2Right SideLeft Side[10947856Figure 3L03065 2.0 9/2019Figure 49

Chamber1.2.3.4.111513161714125.AcuTrace reader.User Interface (UI).Chamber door handle.Manual door lock openingmechanism cover.Cartridge door. Warning: Do NOTforce open (cartridge door willautomatically open when required).6.7.8.9.10.11.12.13.14.Waste drawer.Power switch.Power socket.Ethernet port.3 x USB Ports.* **Chamber door (opened).Chemical Indicator holder.Probe in correct position.Door lock mechanism. Warning: DoNOT put fingers into mechanism.15. Cable clamp.16. Cable seal.17. Integrated Probe Positioner (IPP).Figure 5* trophon2 does not support Wi-Fi dongles or3G/4G dongles.** The 3 USB ports may be used in any order.B1.2 Cable TrayThe cable tray holds the ultrasound cable away from the chamber door and stores the cable duringHLD. Remove the tray for cleaning (figure 6) and wipe with a cloth moistened with a soapy solution.11Figure 6L03065 2.0 9/201910

SECTION B2: Installation GuideB2.1 Positioning your trophon2trophon2 weighs approximately 22kg (48.5 lbs). Follow your facilities manual handlingprocedures for guidance on lifting heavy objects1. Ensure the surface is level, can support the weight and allows adequate airflow (see Appendix1).2. There are no specific illumination requirements to use the trophon2. Follow your facilitiesstandard for work environment illumination guidance.3. Ensure the area around your trophon2 is free from other equipment and clutter. Position as shownin Figure 7 to ensure access to all features.The trophon2 can also be mounted to the wall using the trophon Wall Mount 2 or for a mobilesolution, the trophon Cart. Please refer to the product IFUs for details.The trophon2 should be placed at a height from the floor level to accommodate a range ofuser heights. Refer to Figure 8 for a guide to an ergonomically safe work zone.Distance on each side oftrophon2:A 250mm (10 in)B 250mm (10 in)(not to scale)Figure 7Suggested Mounting HeightFigure 8L03065 2.0 9/201911

B2.2 Powering OnThe trophon2 must not be connected to the same circuit as a critical patient or life supportdevice.1. Attach the power cable supplied to the trophon2 power socket.2. Connect to mains power.3. Turn on the power switch, located on the left side of the trophon2.NOTE: To maximise the life of the disinfectant cartridge, keep your trophon2 switched on at all times,except when moving the device.B2.3 Initial SetupThe Initial Setup launches automatically, prompting you to configure the optional settings whenturning on the trophon2 for the first time. Follow the on screen instructions.B2.4 Warm up Cycle1. The warm up cycle prepares the trophon2 for operation and will begin automatically when themachine is powered on.2. The screen message will indicate when the trophon2 is ready for use. Follow the on screeninstructions.B2.5 trophon2 Touch ScreenThe trophon2 is operated using the touch screen User Interface (UI).NOTE: The UI can be used with gloves.Cleaning the trophon2 Touch ScreenThe screen can be wiped clean using a soft, nonabrasive and lint-free cloth or wipe.B2.6 Basic SettingsThe available settings are:Sleep timer: The default inactive period until the trophon2 enters sleep mode is two hours, whichcan be adjusted in this setting.LanguageDateTime: For record accuracy, user must set the timezone in this setting in addition to the time.Printer labelDaily timers: Configure a preset daily wake and sleep timeBrightness and AlarmNetworkTo access:1. Select Menu Settings2. Select the required setting and follow the on screen prompts.B2.7 AcuTraceTMAcuTrace is an automated HLD traceability system that incorporates Radio Frequency Identification(RFID). AcuTrace enabled accessories and consumables contain RFID chips that store digitalinformation and can be read by the in-built AcuTrace reader.L03065 2.0 9/201912

The trophon2 AcuTrace Reader is located on the device as shown:AcuTrace compatible products that are embedded with an RFID chip can beidentified by this symbol:Scan the symbol on the AcuTrace reader when prompted.Products that are AcuTrace compatible have this symbol on the outer packaging:This symbol cannot be read by the AcuTrace reader.The following products are compatible with AcuTrace:trophon AcuTrace Operator Cardtrophon AcuTrace Operator Card links the HLD cycle t