Transcription

ENGLISHtrophon EPRUser Manualtrophon EPR User Manual – N00020L00034 1.0 03/20141

This manual must be read prior to operating the trophon EPR to ensure correctprocedures are followed and the specified disinfection results are achieved.All technical specifications and system approvals are found in Appendix I of thismanual. 2014 Nanosonics Limited. All rights reserved.The written and graphic product descriptions in this manual are correct at the timeof printing.trophon and NanoNebulant are registered trademarks of Nanosonics Limited.Nanosonics’ technologies are protected by a combination of patents, trademarks,and exclusive proprietary rights.Your sales representative is:Attach Business Card or information sticker/stamp hereVisit the Nanosonics website to obtain this user manual in other languages.Email:Nanosonics LimitedNanosonics Europe GmbHRussian Distributor: AVA MedicaUnit 24, 566 Gardeners RdFalkenried 88,Kondratyevskiy prospectAlexandria NSW 2015House A, D-2025115/3 Office 344,AustraliaHamburg – GermanySt Petersburg RussiaTel: 61 2 8063 1600Tel: 49 40 46856885Tel: 7 911 101 6710Fax: 61 2 9317 5010Fax: 49 40 .nanosonics.com.auConforming to MDD 93/42/EECFSZ 2009/05867 25/12/2009trophon EPR User Manual – N00020L00034 1.0 03/20142

Table of ContentsPART A – INTRODUCTION AND INITIAL SETUP . 4SECTION A1: INTRODUCTION TO THE TROPHON EPR . 4SECTION A2: IMPORTANT WARNINGS, LABELS and SYMBOLS . 5SECTION A3: OVERVIEW OF DEVICE FEATURES . 8SECTION A4: INSTALLATION GUIDE. 10PART B – ROUTINE USE AND MAINTENANCE . 14SECTION B1: LOADING THE DISINFECTANT . 14SECTION B2: ROUTINE HIGH LEVEL DISINFECTION CYCLE . 15SECTION B3: PURGE CYCLE. 19SECTION B4: REMOVING and DISPOSING OF USED DISINFECTANT CARTRIDGES . 20SECTION B5: INCOMPLETE OR FAILED CYCLES . 21SECTION B6: ROUTINE CARE AND MAINTENANCE . 23SECTION B7: DISPOSAL OF DEVICE . 23PART C – TROUBLESHOOTING. 24PART D – TROPHON PRINTER (Accessory) . 26SECTION D1: INTRODUCTION AND SETUP . 26SECTION D2: ROUTINE CARE AND MAINTENANCE. 29SECTION D3: TROPHON PRINTER TROUBLESHOOTING . 30SECTION D4: TROPHON PRINTER DISPOSAL. 32SECTION D5: REORDER INFORMATION . 32SECTION D6: TROPHON PRINTER TECHNICAL SPECIFICATIONS . 32PART E – SERVICE AND WARRANTY. 33APPENDIX 1: TROPHON EPR TECHNICAL SPECIFICATIONS. 33APPENDIX 2: PRODUCT WARRANTY AND REGISTRATION FORM . 34trophon EPR User Manual – N00020L00034 1.0 03/20143

PART A – INTRODUCTION AND INITIAL SETUPSECTION A1: INTRODUCTION TO THE TROPHON EPRFor any operating, fault or maintenance queries, please contact your customer servicerepresentative.A1.1Validated ProbesNOTE: Do NOT use the trophon EPR to disinfect non-approved devices or instruments.Refer to www.nanosonics.eu/trophon-EPR/Brochures for a list of Validated Probes for use withtrophon EPR.Refer to the original equipment manufacturers of the ultrasound equipment for theirrecommendations and the most up-to-date list of validated disinfectants for use with theirprobes.A1.2TrainingIt is the owner’s responsibility to ensure that all users: Are trained as per the instructions contained in this manual to ensure safe operation. Are aware of the potential hazards in dealing with the disinfectant and safetyprocedures associated with the device. Visit the Nanosonics website to complete the online training module and receive yourtrophon EPR certification, before setting up or using your trophon EPR,www.nanosonics.euA1.3User and Environment ProfileNOTE: The following description is intended for general information only. For specificoperating instructions, please refer to the relevant sections of this manual.The trophon EPR will be used in typical health care environments, under the control of healthprofessionals such as: Sonographers General Practitioners Nurses Radiographers Specialist Doctors (e.g. cardiologists, obstetricians, gynaecologists, sonologists)In locations such as: Hospitals with centralised cleaning rooms Hospitals without specific cleaning rooms Radiology/Ultrasound sites with centralised cleaning rooms General practices and specialised doctors rooms without cleaning roomstrophon EPR User Manual – N00020L00034 1.0 03/20144

Intended Use: The sole purpose of the trophon EPR is to high level disinfect validated ultrasoundprobes (see section B2.1) according to the specified processes outlined in this manual.It is not intended for any other use. Do NOT use this device for any application otherthan its expressed purpose. The trophon EPR together with the NanoNebulant is a high-level instrument gradedisinfectant system. The trophon EPR is NOT intended to reprocess single use devices The trophon EPR is NOT intended to pre-clean ultrasound probes The cable management system is an accessory designed for use with the trophon EPR(see section A4.2) Chemical Indicator use is required with every disinfection cycle. More information canbe found in the Chemical Indicator Instructions for use, provided with the ChemicalIndicator. The trophon Printer, trophon Connect, trophon Wall Mount and the trophon Cart areaccessories designed for use with the trophon EPR; contact your customer servicerepresentative or visit the Nanosonics website for additional information. Refer to Part Dfor information on the trophon Printer.Disinfection Process:At the beginning of the cycle, the trophon EPR creates an aerosol of concentratedhydrogen peroxide. This is quickly and evenly distributed over the surface of the probe,including very small crevices. This process provides thorough, high level disinfection of theshaft and the handle of the probe. The device breaks down the hydrogen peroxide intosmall amounts of water and oxygen and safely vents them into the external environment.Notes:1) NanoNebulant is the product name of the trophon Disinfectant.2) The contact conditions are fixed cycle parameters that are not able to be modified by theend user.SECTION A2: IMPORTANT WARNINGS, LABELS and SYMBOLSFailure to read the following sections may result in damage to the trophon EPR, disinfectantcartridges or other equipment, or cause serious injury to the operator or other persons. If thedevice is used in a manner not specified by the manufacturer, the protection provided bythe device may be impaired.A2.1WarningsHot Temperatures Risk of burns from the hot surfaces in the internal chamber. Do NOT touch thesesurfaces. A hot surface symbol is located inside the trophon EPR chamber as areminder. Failure to correctly load the probe into the chamber may result in damage to theprobe. Probe must NOT come into contact with the chamber wall. Refer to sectionB2.3 for correct positioning of probe.trophon EPR User Manual – N00020L00034 1.0 03/20145

Malfunctions Do NOT attempt to open the chamber door during a cycle or in the event of a powerfailure or system malfunction (see section B5.1). All repairs must be carried out by trained personnel ONLY. Do NOT attempt to repair ormodify any part of the device. The trophon EPR contains no end user serviceable parts.Transporting the Device The device weighs approximately 17kg (38lb). Use safe lifting techniques as per yourOccupational Health and Safety Lifting Guidelines for your institution. Do not move, relocate or transport the device if hydrogen peroxide is present; purgethe device before moving or relocation (See section B3).Electrical Device Equipment must be connected to an earthed power outlet. Ensure power cablesupplied with the device is used. Spilled fluid can result in electrical shock. Do not allow any fluid to spill onto or aroundthe device or immerse any parts of the trophon EPR in liquid. Connect the device only to an electrical source with the proper voltage andfrequency as specified in Appendix 1. If incorrect voltage is used, the device may bedamaged when it is switched on. Attempting to open any component of the device to gain access to the internalmechanics may result in electrical shock.trophon Chemical Indicator ONLY to be used with the trophon EPR. Do NOT use with non-approved devices. Use one Chemical Indicator with every trophon EPR cycle. Do NOT use damaged and/or out-of-date indicators. Ensure indicator is red and not exposed before use. More information can be found in the Chemical Indicator Instructions for Use, providedwith the Chemical Indicator.trophon NanoNebulant Read the Instructions for Use (IFU) leaflet enclosed with the trophon NanoNebulant andthe Material Safety Data Sheet (MSDS) enclosed with the device. Always wear disposable gloves when handling disinfectant cartridges and running thetrophon EPR device. Ensure appropriate personal protective equipment (PPE) is worn during spills(according to the Occupational Health and Safety Guidelines for your institution andNanoNebulant MSDS).trophon EPR User Manual – N00020L00034 1.0 03/20146

A2.2Labels and SymbolsCautionCorrosiveConsult instructions for useWarningStart (of action)Single Use OnlyFragile / Handle With CareWarning: HotSurfaceDo not disassembleDangerousVoltageSeparate collection forelectrical and electronicequipmentKeep DryKeep Out of Direct SunlightExpires(year and month)Batch NumberProduct NumberCannot be transported by airfreightThis Way UpUN 2014Wear Gloveswhen handlingcartridgesProbe Guidetrophon EPR User Manual – N00020L00034 1.0 03/20147

SECTION A3: OVERVIEW OF DEVICE FEATURESA3.1Front Panel and Back PanelFront Closed(Figure 1)1. User screen: displaysmessages and menu2. Start button3. Soft key buttons4. Chamber door handleFigure 1Back(Figure 2)5. Adjustable Feet (forlevelling the device)Note: Serial Number (SN)can be located on theback labelFigure 2trophon EPR User Manual – N00020L00034 1.0 03/20148

A3.2 Chamber (Figure 3)Chamber(Figure 3)6. Chamber door(opened)7. Probe in correctposition8. Cable clamp9. Gland sealFigure 3A3.3 Side Panels (Figure 4 & 5)Left Side(Figure 4)10. Power switch11. Power socket12. Serial port (forauthorised personnelonly)Note: Serial Number canFigure 4trophon EPR User Manual – N00020be located on the labelabove the power socketL00034 1.0 03/20149

Right Side(Figure 5)Do NOT force open thecartridge door. Cartridgedoor will automaticallyopen when required.13. Cartridge door14. Waste containerFigure 5SECTION A4: INSTALLATION GUIDEA4.1Positioning the deviceNOTE: Ensure the device is placed on a surface that can support the weight of the device(see Appendix 1).1. Ensure the area around the device is free from other equipment and clutter. Positioningthe trophon EPR as shown in Figure 6 will ensure access to all features including thecartridge system and for disconnecting the device.Distance on each sideof device:A 250mm(10 in)B 250mm(10 in)(Figure 6 – not to scale)Figure 62. Level the device by adjusting the back feet – turning feet clockwise or anti-clockwise(see Figure 2). Ensure feet are present at all times, and are not loose.NOTE: If the device needs to be relocated, see section B3.3 – Transportationtrophon EPR User Manual – N00020L00034 1.0 03/201410

A4.2Cable Management System InstallationThe Cable Management System is designed to facilitate ease of use of the trophon EPR byholding the ultrasound cable away from the chamber door, and providing a convenientlocation to store the cable during High Level Disinfection. Refer to section B2.3 for using theCable Management System.To install the Cable Management System:1. Open the chamber door before mounting the Cable Management System to thedevice.2. Peel back the protective strip from the double sided tape on the bottom of the CableManagement System (see Figure 7)3. Align and slide the two hooks on the front of the Cable Management System into theslots in the device chamber (see Figure 8-1) until it cannot slide any further.4. Push Cable Management System down on top of the device to secure it in place (seeFigure 8-2).Figure 7Figure 8A4.3Powering On1. Attach the power cable supplied with the device to the device power socket.Equipment must be connected to an earthed outlet.2. Switch on at the mains power3. Turn on the power switch, located on the side of the device to ‘ON’trophon EPR User Manual – N00020L00034 1.0 03/201411

A4.4Basic SettingsDate and Time1. Press the soft key button underneath MENU on the screen2. Using the soft key buttons under the LCD: Scroll to SETUP using the buttons under the arrows and press OK Scroll to SET DATE AND TIME using the buttons under the arrows Set the date and time by using the button under NEXT to move through each setpoint and the arrows to scroll to the desired date and time Once each set point is set press OK The screen will now revert back to the menu screen To change date and time format select SETUP using the buttons under the arrowsand press OK Scroll to CHANGE DATE FORMAT or CHANGE TIME FORMAT using the buttons underthe arrows Press OK once complete The screen will now revert back to the menu screen.Language1. Press the soft key button underneath MENU on the screen2. Using the soft key buttons under the LCD: Scroll to SETUP using the buttons under the arrows and press OK Scroll to LANGUAGE using the buttons under the arrows and press OK Scroll to the desired language using the buttons under the arrows and press OK The screen will now revert back to the menu screenAlarm Settings1. Press the soft key button underneath MENU on the screen2. Using the soft key buttons under the LCD: Scroll to SETUP using the buttons under the arrows and press OK Scroll to ALARM SETTINGS using the buttons under the arrows and press OK Set the alarm volume by pressing the up & down buttons to set the volume on highor low. Press Ok to confirm selection. Scroll to ALARM REPEAT using the buttons under the arrows and press OK Set the alarm to repeat by pressing the up & down buttons to turn on or off thealarm repeat. Press OK to confirm selection If alarm repeat is enabled, the alarm will repeat every minute for the followingsituations:a. The probe is left in the deviceb. Error message is displayed and requires a responsetrophon EPR User Manual – N00020L00034 1.0 03/201412

A4.5Warm-up Cycle1. This cycle prepares the device for operation2. The warm up will begin automaticallyScreen MessageQuick Warm UpApproximate Warm Up Time(minutes) 2 minutesWarming Up2 – 30 minutesExtended Warm Up 30 minutes3. During the warm up cycle some instructions may appear on the screen. Please followthese instructions, which may include: Close Chamber Door Cartridge Empty. Replace Cartridge Now (Refer to section B1) Remove Probe From Chamber4. When completed, the screen message will read: LOAD PROBE AND INDICATOR5. The machine is now ready for useNOTE: It is recommended that the device remains switched on at all times to maximise thelife of the disinfectant cartridge, unless the machine needs to be moved.trophon EPR User Manual – N00020L00034 1.0 03/201413

PART B – ROUTINE USE AND MAINTENANCESECTION B1: LOADING THE DISINFECTANTB1.1Disinfectant Specifications and HandlingRead the Instructions for Use (IFU) leaflet enclosed with the trophon NanoNebulant and theMaterial Safety Data Sheet (MSDS) enclosed with the device.Always wear disposable gloves when handling disinfectant cartridges.WARNING: Failure to follow specifications and handling instructions may compromise theeffectiveness of the disinfection process and/or cause injury to the operator.B1.2Inserting the Disinfectant Cartridge1. Cartridge door will automatically open when cartridge needs replacing. Do NOTforce the Cartridge Door open as this may damage and render the device nonfunctional.2. Screen message: CARTRIDGE EMPTY. REPLACE CARTRIDGE NOW is displayed.3. Press the button under OK to open the cartridge door.4. Do NOT insert empty cartridges into the device.NOTE: Always check the expiration date on the cartridge before use. If the cartridge hasexpired, dispose of as per local environment and government regulatory requirements. Donot attempt to open or load a damaged or distorted cartridge. Do not manually pierce thecartridge.Refer to IFU enclosed with the trophon NanoNebulant for detailed instructions on how to installand/or replace trophon NanoNebulant cartridgesNOTE: Cartridges will last for approximately one month from date of installing, depending onusage and whether the device has been switched off.B1.3Spillage of Disinfectant Wear PPE appropriate for the spill (according to the Occupational Health andSafety Guidelines for your institution and NanoNebulant MSDS). Never return spills to original cartridges for re-use. Contain and clean-up the spill by placing spill control materials over the entire spillarea.B1.4Customised Disinfectant Cartridges Use ONLY the trophon NanoNebulant cartridges which are validated for use withthe trophon EPR Each cartridge is to be used ONCE. Do NOT refill or reuse cartridgestrophon EPR User Manual – N00020L00034 1.0 03/201414

SECTION B2: ROUTINE HIGH LEVEL DISINFECTION CYCLEThe effectiveness of the device cannot be guaranteed if non-approved accessories areused. Do NOT use the trophon EPR to disinfect non-approved devices or instruments.B2.1Validated Probes for use with trophon EPRFor details of probes that are able to be used in the trophon EPR refer to the following: Nanosonics website www.nanosonics.eu The manufacturer of ultrasound equipment for their recommendations and the mostup-to-date list of validated disinfectants for use with their probesNOTE: Only validated probes should be placed in the trophon EPR. All probes referred to onthe Validated Probe List have been tested and validated according to the manufacturer’sspecifications.B2.2Preparing the ProbeThe probe must be pre-cleaned and dried BEFORE the High-Level Disinfection process cancommence in the trophon EPR.NOTE: Failure to clean and dry the probe may result in: high-level disinfection will not be achieved during the trophon EPR disinfection cycle residual disinfectant remaining on the probe potential exposure to residual disinfectant, which may cause injury, when removingprobe; this may lead to temporary bleaching and/or irritation of the skin if no glovesare wornRefer to probe manufacturer’s instructions for correct cleaning process.B2.3Positioning the ProbeNOTE: Probe must be correctly inserted in the device for a high-level disinfection cycle tooccur.1. When the device is ready, screen message: LOAD PROBE AND INDICATOR2. Open chamber door3. The probe is held securely in the chamber by the use of two clamps; refer to Figure9(a).The probe has a short sleeve at the back of the handle, covering the electrical cable.This is referred to as the PROBE GLAND - Figure 9(a)Wearing