STERILUX SterOx System V Series Instructions For Use Manual

STERILUX SterOx System V Series Instructions For Use Manual

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SterOx System V-Series
Ozone Sterilizer Instruction for Use
SFT-0034-V02-IFU_SterOx_System_V-Series

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Summary of Contents for STERILUX SterOx System V Series

  • Page 1 SterOx System V-Series Ozone Sterilizer Instruction for Use SFT-0034-V02-IFU_SterOx_System_V-Series...
  • Page 3 SteriLux SA. Information in this manual is subject to change without any warning or prior notice by SteriLux SA. SteriLux SA Chemin du Viaduc 12 1008 Prilly – Switzerland T: +41 (0) 21 546 43 33 | E: info@sterilux.ch | www.sterilux.ch...
  • Page 4: Table Of Contents

    Table of contents Introduction ..................................................5 Symbols ....................................................6 Important information ..............................................7 Disclaimers ..................................................................................7 Declaration of Conformity ............................................................................7 Field of application ...............................................................................7 Warning .................................................................................... 8 Products overview ................................................9 SteriBase V-Series (SKU-0006) ..........................................................................9 SteriBox V-Series (SKU-0007) ...........................................................................10 Principles of operation ..............................................11 Setting up your SteriBase V-Series ..........................................
  • Page 5: Introduction

    The processing of such loads may result in incomplete sterilization and / or damage to the load and / or to the sterilizer. For more information about instruments compatibility with ozone sterilization, please contact SteriLux SA directly.
  • Page 6: Symbols

    Symbols The following table displays the different symbols used in the margins of this manual and/or on the product and summarizes their meaning. Serial number Catalogue number Batch code Date of manufacture Manufacturer Use-by date CE marking Consult instructions for use Caution, consult the instructions for use for important cautionary information Keep away from sunlight Keep dry...
  • Page 7: Important Information

    Do not permit any person other than certified personnel to supply parts for service or maintain your SterOx System V-Series. SteriLux SA shall not be liable for incidental, special or consequential damages caused by any maintenance or services...
  • Page 8: Warning

    Warning Careful monitoring of the shelf-life and/or the maximum allowable number of cycles of the different components of the SterOx System V-Series is essential to ensure the required sterility assurance level (SAL) at the end of the cycle. Never use components that have an expired shelf-life or exceeded the allowable number of cycles.
  • Page 9: Products Overview

    Products overview 4.1 SteriBase V-Series (SKU-0006) Touchscreen Start button Handle Manual levers (of the Lamp Unit) Cooling fan Thermal printer Nitrogen plug Power switch Power cable port When you receive your SteriBase V-Series, the items listed below should be included. If any of the items are missing or damaged, contact your supplier immediately.
  • Page 10: Steribox V-Series (Sku-0007)

    4.2 SteriBox V-Series (SKU-0007) Quartz window Incorporated RFID tag Module and clip Bottom Locks When you receive your SteriBox V-Series, the items listed below should be included. If any of the items are missing, contact your supplier immediately. • SteriBox V-Series Lid •...
  • Page 11: Principles Of Operation

    Principles of operation The SterOx System V-Series is an ozone-based sterilizer. 172 nm UV lamps contained in the Lamp Unit inside the SteriBase V-Series ( 1 ) transform oxygen (O ) from ambient air into ozone (O ) ( 2 ). Ozone further reacts with water (H O) to form hydroxyl and hydroperoxyl radicals ( 3 ) which are responsible for the inactivation of micro-organisms causing infections and disease transmissions ( 4 ).
  • Page 12: Setting Up Your Steribase V-Series

    Setting up your SteriBase V-Series 6.1 Installing your device There are several factors that may affect the performance of your SteriBase V-Series. Please review these factors and select a suitable location in which to install the device. After each relocation of the sterilizer, installation must be carried out according to the protocol. Safety of any system incorporating the device is the responsibility of the assembler of the system.
  • Page 13: Powering Your Device

    MAINTENANCE and click on MAINTENANCE PROGRAM. Note: It is possible to use other commercially available nitrogen supply cylinders. However, if you decide to go with another alternative, you must have SteriLux SA written approval prior to installing it on your SteriBase V-Series.
  • Page 14: Setting The Time And Date

    6.4 Setting the time and date PARAMETERS DATE AND TIME From the DATE AND TIME screen, press to set the hours and minutes then press to save your changes From the DATE AND TIME screen, press to set the day, month and year then press to save your changes 6.5 Setting the language...
  • Page 15: Connecting To A Wireless Network

    6.8 Connecting to a Wireless Network PARAMETERS WI-FI Verify that Wi-Fi is enabled Press and click on Connect to a Wi-Fi network Select your Wi-Fi within the list of Wi-Fi Enter the Wi-Fi password if required and press OK...
  • Page 16: Using The Steribox V-Series And Preparing Instruments

    Using the SteriBox V-Series and preparing instruments 7.1 Using the SteriBox V-Series When removing the SteriBox V-Series from the SteriBase V-Series, exercise caution as the quartz window area may be hot. Opening the SteriBox V-Series Disengage both locks Stand behind the SteriBox V-Series and grab the handles on both sides of the lid Pull the lid towards yourself Rest the lid on its outer surface Take the module out with sterile gloves and place it inside the lid...
  • Page 17: Preparing And Loading Instruments In The Steribox V-Series

    Place the wrapped instruments in the SteriBox V-Series or on a rack and arrange them to avoid overlap. Always ensure that porous side of the pouches are facing upwards. The use of cloth wraps in the SterOx System V-Series is strictly forbidden. SteriLux SA highly recommends the use of Tyvek®-plastic sterilization pouches.
  • Page 18 Use of these materials may lead to instrument or equipment damage. If you are unsure of your instrument’s material or construction, do not load into your SterOx System V-Series until you have checked with the instrument manufacturer and/or SteriLux SA. All instruments...
  • Page 19 Indicator Instructions for Use for detailed instructions. Note for hollow instruments SteriLux SA cannot guarantee that the inside of hollow instruments can be sterilized by the SterOx System V-Series. Overall, channels with greater length than 10 cm and smaller inner diameter than 3 mm of material different than stainless steel have not been cleared to be reprocessed in the SterOx System V-Series.
  • Page 20: Using Your Sterox System V-Series

    Using your SterOx System V-Series 8.1 Preparing device for use Once the device is installed and before any cycle is launched, clean and disinfect the lid, bottom and module of the SteriBox V-Series (see chapter 11 for further details). Pay special attention to thoroughly clean the quartz windows, both on the SteriBox V-Series and the SteriBase V-Series, using isopropyl alcohol (IPA).
  • Page 21: Running A Cycle

    8.3 Running a Cycle To operate each cycle, follow these steps. Turn the power switch on the right side of the device to ON, then press the start button in front. At start up, the device will display the main menu. Insert your SteriBox V-Series as explained in chapter 7.1.
  • Page 22: Stopping A Cycle

    8.4 Stopping a Cycle To stop a cycle, press the INTERRUPT CYCLE button. If this button is pushed, a confirmation pop-up will appear on the touchscreen. Interruption of a cycle will automatically turn the UV lamp on to remove remaining ozone for 45 minutes. The device can also detect a problem while operating and automatically stop the cycle.
  • Page 23: Storing And Retrieving Cycle Information

    Storing and retrieving cycle information The SteriBase V-Series has an internal Data Logger capable of storing all cycle data on every cycle, whether successful or incomplete, for the lifetime of the device. You can access this information through the touchscreen, using a USB storage device or by email if you decide to set an email address.
  • Page 24: Retrieving Cycle Information Using An Email Address

    9.3 Retrieving cycle information using an email address For each cycle realized, a detailed PDF document is generated including all relevant information about the cycle. These PDF documents can be retrieved directly to an email address predefined by the user. To define your email settings: PARAMETERS EMAIL SETTINGS From the EMAIL SETTINGS screen, you can:...
  • Page 25: Maintaining Your Sterox System V-Series

    Keeping the SteriBox V-Series clean is good clinical practice and assists good functioning of the device. SteriLux SA recommends that the interior surface be cleaned regularly. Use a soap compatible with materials embedded in the SteriBox V-Series and its components to scrub the inside of the SteriBox V-Series with a cleaning pad to remove all traces of residues, dust, organic materials, lubricant, etc.
  • Page 26: Preventive Maintenance

    To ensure trouble-free performance, it is recommended to perform a preventive maintenance once a year. This preventive maintenance has to be done only by certified personnel from SteriLux SA. NOTE: Please refer to your National, Regional, State of Safety laws for any additional reoccurring user testing that may be required.
  • Page 27: Troubleshooting Your Sterox System V-Series

    If there is, contact SteriLux SA for assistance. If not, do not open the SteriBox V-Series and contact SteriLux SA for assistance as the 254 nm UV Lamp might not be working and the amount of ozone in the SteriBox V-Series could be harmful for the user if exposed.
  • Page 28 Verify that there is enough storage space on your USB. Delete the USB upload failed SteriLux folder from the USB key folder, restart device and try again. If the problem persists, change USB key. Verify that the WiFi has been enabled. Verify that you chose the right WiFi connection failed WiFi and entered the correct password.
  • Page 29: Spare Parts

    13 Spare parts SterOx System V-Series SterOx System V-Series Spares Consumables and Components INT-0050 Lamp Unit SKU-0004 OZONE STRIP type 4 RAM-00104 172 nm UV Lamp SKU-0005 HUMIDIFY RAM-00105 254 nm UV Lamp SKU-0007 SteriBox V-Series RAM-00111 Quartz Window SKU-0017 Nitrogen starter kit RAM-00039 DC Power Supply...
  • Page 30: Recycling And Disposal

    14 Recycling and disposal The SterOx System V-Series is mainly built from polymers, metals and electric/electronic components. In case of disposal: • Separate the various components according to the materials they are made of • Drop the sterilizer with a company that specializes on the recycling of related products •...
  • Page 31: Warranty

    SteriLux SA’s option and without charge, of any defected part(s), provided SteriLux SA is notified in writing within seven (7) days of the date of such a failure and further provided that the defective part(s) are returned to SteriLux SA prepaid.
  • Page 32: Specifications

    16 Specifications SteriBase V-Series dimensions: Length: 518 mm Width: 296 mm Height: 437 mm SteriBase V-Series weight: 18.5 kg SteriBox V-Series size (External): Length: 630 mm Width: 318 mm Height: 194 mm SteriBox V-Series size (Internal): Length: 554 mm Width: 260 mm Height: 104 mm...
  • Page 33: Appendix

    17 Appendix 17.1 Electromagnetic compatibility – Environment The equipment under test is intended for industrial electromagnetic environment. In a domestic environment this product may cause radio interference in which case the user may be required to take adequate measures. Verification of all devices in simultaneous operation are required to ensure the electromagnetic compatibility and co-existence of all other devices prior to use of SteriBase V-Series.
  • Page 34: Electromagnetic Compatibility - Performance Levels

    Applicable Emission Test Limits Standards Quasi-peak Average value Frequency value (dBμV) (dBμV) Limits for conducted disturbance at mains ports 150kHz-30MHz 150-500MHz EN 61326-1 (2013) 0.5-30MHz EN 55011 (2009) and A1 (2010) Quasi-peak value (dBμV) Frequency @ 10 meters Radiated emissions 30-230 MHz 30MHz-1GHz 230MHz-1GHz...
  • Page 35: Accessories Replacement

    Function/Item Success criterions- Parameter(s) Success criterions-B Success criterions-C to be tested State of Generation State of Generation 172 nm UV State of Generation Control Pin must be Control Pin must be Lamp Control Pins LOW for at least LOW for at least 50% 99% of time of time State of Destruction...

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