3M Steri-Vac GSX Series Operator's Manual
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3M Steri-Vac GSX Series Operator's Manual

Sterilizer / aerator
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Summary of Contents for 3M Steri-Vac GSX Series

  • Page 1 Steri-Vac ™ ™ Sterilizer/Aerator GSX Series Operator’s Manual...

  • Page 2: Table Of Contents

    1122 Software Requirements 32 1354 Software Updates 71 11�3� Installing the 3M™ Cycle Programmer �����������������������32 2 Intended Use  5 1355 Firmware Updates 71 11�4� Creating a Cycle in the 3M™ Cycle Programmer �������34 13�6� Distilled Water Reservoir ���������������������������������������������72 3 Safety  6 11�5� Defining Set Points for Cycle Stages and Parameters �37 13�7� Printer Overview ����������������������������������������������������������72 4 Dangers and First Aid  7...

  • Page 3: Explanation Of Symbols

    Steri‑Vac Sterilizer / Aerator GSX Series – Operator’s Manual ™ ™ Explanation of Symbols: product and package labels and pictograms Refer to the package and product labels to see which symbols apply to specific products Attention ‑ Refer to the Operator Manual for additional information Warning ‑...

  • Page 4: Explanation Of Symbols: Operator Manual

    The 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series hardware and software are subject to change The system images, screen images, hardware components, and hardware specifications included in the manual may not match the system as installed In the event that hardware or software changes are made, 3M will verify their compatibility with the functionality described in this document...

  • Page 5: Description

    (eg drug‑device combination products) The 3M Cycle Programmer allows programming of 28  different parameters in eight of the nine active stages of the EO sterilization process and operates on a personal computer (PC) supplied by the user Custom cycles are created with the 3M Cycle Programmer and imported to the GSX Series sterilizer using a USB drive...

  • Page 6: Intended Use

    The 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series’ ethylene oxide (EO) sterilization cycles consist of ten stages After the sterilization cycle is complete, an aeration cycle is required to remove any residual EO from the medical devices per manufacturers’ instructions for use (IFUs) An EO sterilization cycle is defined as a treatment in a sealed, temperature‑controlled chamber comprised of air removal, conditioning, and injecting of EO, exposure to EO, removal of EO and flushing, aerating, and air admission allowing the opening of the chamber door Figure 1 is a graph of a Pressure Profile of the cycle stages of a GSX Series sterilizer EO sterilization cycle...

  • Page 7: Safety

    • Over‑the‑door vent hood (ie exhaust hood) supplements the room’s directional air flow, and draws air away from Operators removing a load from the chamber • The GSX Series sterilizers are designed with a specialized disposal cycle for full damaged, expired, or excess 3M™ Steri‑Gas™ EO Gas Cartridges The Cartridge Dispose Cycle is a custom, abbreviated cycle that safely empties and aerates the Steri‑Gas EO Gas Cartridges at a rate of one per cycle Disposal cycles have restricted access to a Supervisor PIN only...

  • Page 8: Dangers And First Aid

    Do not use damaged 3M™ Steri‑Gas™ EO Gas Cartridges If an individual 3M™ Steri‑Gas™ EO Gas Cartridge is ever dropped, the cartridge should be used immediately or disposed of as described in the cartridge disposal section of this manual Sterilize only medical devices manufactured with materials compatible with ethylene oxide (EO) sterilization processes Do not sterilize leather, liquids, or materials reactive to EO Ensure that the compressed air supply is clean, with a maximum allowable dirt particle size of 05 microns, and that the air supply is free of oil Ensure that the air filters on the compressed...

  • Page 9: 4�2� First Aid

    • Toxic if inhaled • Causes serious eye irritation • May cause drowsiness or dizziness • Suspected of damaging fertility or an unborn child • May cause cancer • May cause genetic defects Consult the 3M™ Steri‑Gas™ EO Gas Cartridge Safety Data Sheet (SDS) for additional information (www.3M.com).

  • Page 10: Warnings

    WARNING: To reduce the risks associated with fire and explosion: 3M™ Steri‑Gas™ EO Gas Cartridges contain 100% ethylene oxide (EO) which is an extremely flammable gas and a liquid under pressure Do not use near flame, electrical sparks, hot surfaces, or allow sources of ignition near the cartridges Do not puncture cartridge outside the sterilization chamber Do not incinerate cartridges Exposure to temperatures above 150ºF (655ºC) may cause cartridge to burst...

  • Page 11: Cautions

    Do not operate the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series outside the environmental conditions as stated in this manual Immediately call 3M Health Care service personnel or authorized 3M service personnel if there is a failure of the display or backlight and the GSX Series sterilizer continues to operate...

  • Page 12: Specifications

    7 Specifications 7.1. 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series Structural Specifications GS5X GS8X 127 kg (281 lbs) single door 261 kg (576 lbs) single door Operational Weight 132 kg (290 lbs) double door 269 kg (593 lbs) double door H 709 cm x W 762 cm x D 950 cm H 1798 cm x W 940 cm x D 1090 cm Exterior Dimensions H 279 in x W 300 in x D 374 in...

  • Page 13: 7�4� Air Supply Specifications

    The 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series complies with the CE mark related to the Low Voltage Directive (LVD) 2006/95/EC as confirmed in the Declaration of Conformity The 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series complies with the RoHS Directive, Directive 2011/65/EU of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment...

  • Page 14: Installation And Set Up

    9 Installation and Set Up To ensure proper operation of this equipment and Operator safety, the 3M™ Steri‑Vac™ Site Planning and Installation Guide must be followed and the equipment must be installed by authorized 3M service personnel To arrange installation, contact your local 3M subsidiary (www3mcom)

  • Page 15: 9�2� Room And Installation Requirements

    9.2. Room and Installation Requirements DANGER: To reduce the risks associated with exposure to ethylene oxide, ensure a minimum of ten (10) air exchanges per hour (ACHs) for the room in which the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series is installed Location Do not place the sterilizer or ethylene oxide (EO) cartridges in an area of possible ignition sources ONLY USE INDOORS...

  • Page 16: 9�3� Set Up And Connections

    9.3. Set up and Connections Figures 3 ‑ 7 illustrate the components and connections for the 3M™ Steri‑Vac™ Sterilizer/Aerator Series, Models GS5X and GS8X Table 3 contains additional details regarding specific components and connections for the GSX Series Models GS5X and GS8X Chamber Door Touch Screen & Display Water Reservoir, Printer & USB Ports...
  • Page 17 Top Connection ‑ 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series 8. User Screen 9. USB Ports 10. EO Gas Cartridge Barcode Scanner 11. Printer w/ Paper 12. Distilled Water Reservoir Figure 6 Front Panel, 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series, Model GS8X 8. User Screen 11. Printer w/ Paper 9. USB Ports 12. Distilled 10. EO Gas Cartridge Figure 7...
  • Page 18 The Abator connection is intended to only be made by 3M Health Care service personnel or authorized 3M service personnel during installation Air inlet is for the connection of the compressed air supply per Chapter 9 and is intended to only be made by 3M Health Care service Air Inlet...

  • Page 19: Using The Touch Screen

    Steri‑Vac Sterilizer / Aerator GSX Series – Operator’s Manual ™ ™ 10 Using the Touch Screen 10.1. Main Screen Figure 8 shows the Main Screen of the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series that appears after the power cycles ON 22.2 98.0 04/20/2015 Sterilizer ˚ 05:19:51 Select cycle: GSX 38C GSX 55C Figure 8...

  • Page 20: 10�3� Reports

    10.3. Reports The 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series has a variety of reporting options as shown in Figure 10 22.2 98.0 04/20/2015 Sterilizer ˚ 05:19:53 Select cycle: GSX 38C Reports Cycle reports GSX 55C Cycles EO usage report Setup Site setup report Status Custom cycle set points Figure 10...
  • Page 21 Steri‑Vac Sterilizer / Aerator GSX Series – Operator’s Manual ™ ™ There are three (3) Cycle Report formats The desired format can be selected in the Cycle Report options screen (Figure 11) Each of the Cycle Report formats is described in Chapter 17 in Table 6 22.2 98.0 04/20/2015...
  • Page 22 1033 Site Setup Report View a Site Setup Report for the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series by viewing, printing, or exporting electronically to a USB drive via Menu>Reports>Site Setup Report The Site Setup Report contains the site settings established in the Site Setup menu Figure 15 is the display screen view of the Site Setup Report 22.2...
  • Page 23 Steri‑Vac Sterilizer / Aerator GSX Series – Operator’s Manual ™ ™ 1034 Printer Form Feed The Printer Form Feed button advances the printer paper by approximately 5cm (2 in) Figure 16 details the location of the Printer Form Feed button 22.2 98.0 Sterilizer 04/20/2015 ˚ 05:19:53 Select cycle: GSX 38C Reports Cycle reports...
  • Page 24 1� Aeration performs aeration only at the selected temperature Duration is user‑programmed in either 30 minute intervals or continuous 2� Cartridge Dispose is a custom abbreviated cycle used to safely empty and aerate 3M™ Steri‑Gas™ EO Gas Cartridges at the rate of one per cycle This cycle cannot sterilize devices Refer to the Cartridge Dispose Cycle ‑...

  • Page 25: 10�5� Setup Menu

    10.5. Setup Menu The Setup Menu provides several options for customizing the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series function and preferences Site setup is specific for the GSX Series sterilizer The User setup is specific for Operators and Supervisors Figure 20 illustrates the button to access the Site Setup options 22.2...
  • Page 26 Table 3 outlines the parameters in Site Setup>Preferences including description, default value, and minimum access level Parameter Display Data Range Default Minimum Access Parameter Description Name (or Format) Value Level to Edit When enabled, system will produce an audible tone upon cycle failure The audible Audible tone on cycle notification will sound at a pulsed rate of two (2) seconds on, one (1) second off, for Disabled, Enabled...
  • Page 27 Figure 23 illustrates changing the minimum aeration default time Minimum aeration times cannot be changed in this view for custom cycles Custom cycle minimum aeration times must be changed in the 3M™ Cycle Programmer and imported back to the GSX Series sterilizer...
  • Page 28 The Site Setup>Date‑Time tab (Figure 25) provides options for setting the date and time for the GSX Series sterilizer 22.2 98.0 04/20/2015 Sterilizer ˚ 12:40:12 Setup Preferences Cycle Setup Date-Time Network Site Date Date format Select cycle temperature: 04/20/2015 MM/dd/yyyy Time Time format 12:40:12 24 hours 55 °C...
  • Page 29 The User Name field will accept 1 to 20 characters from the following character set: A‑Z, a‑z, and 0‑9 Spaces are not accepted Note: 3M Health Care service personnel or authorized 3M service personnel must create the first Supervisor user and PIN on the GSX Series sterilizer. Additional Supervisor users and PINs can be created by established Supervisors...
  • Page 30 22.2 98.0 04/20/2015 Sterilizer ˚ 12:48:57 Edit users Select cycle temperature: CSX 38C CSX 55C Figure 29 User Setup Menu – Blank User List Add user Return Add user Return 22.2 98.0 04/20/2015 Sterilizer ˚ 12:47:56 Add user User name Select cycle temperature: CSX 38C Access level Supervisor...

  • Page 31: 10�6� Status

    The Info tab of the Status option provides version numbers for 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series components and software 1063 Log The Log tab of the Status option provides ongoing output of the software commands while the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series is running a cycle The Log is not saved and is overwritten as new data information appears...

  • Page 32: Cycle Programmer

    Use of custom cycles on the GSX Series sterilizer requires a Supervisor PIN for multiple steps of the custom cycle process 3M Health Care service personnel or authorized 3M service personnel must create the first Supervisor user and PIN on the sterilizer.

  • Page 33: 11�3� Installing The 3M™ Cycle Programmer

    1� To obtain the 3M Cycle Programmer software and company specific license file, register the GSX Series sterilizer installation location and serial number at: www3Mcom/SteriVacServiceLSS 2� An email from 3M Health Care will be sent with instructions on how to download the software A 3M‑generated, company‑specific license file is required to activate the installed 3M Cycle Programmer software The license file accompanies the 3M Cycle Programmer software...
  • Page 34 C:\Users\Desktop\License Files\Cycle Programmer\ Figure 36 Submit Cancel File Loaded and Ready to Submit For Technical Support: In the US, contact 3M Health Care Service Center Customer Service 1‑800‑292‑6298, Option 0 Outside the US, contact your local 3M office or visit www3mcom for locations and contact information...

  • Page 35: 11�4� Creating A Cycle In The 3M™ Cycle Programmer

    The user must validate the sterile efficacy of each custom cycle intended to sterilize products labeled ‘Sterile’  1� Each time the 3M Cycle Programmer is opened, the user must be aware that Flushing and Aeration stages affect occupational exposure levels of ethylene oxide (EO), therefore the user must acknowledge this safety feature prior to creating or modifying a custom EO cycle (Figure 37)...
  • Page 36 9. Aeration Parameter Minimum Set Point Maximum Units ˚C Aeration temperature Minimum aeration time 12.0 Preheat Air removal Chamber test Conditioning EO injection EO exposure EO removal Flushing Aeration Estimated total cycle time 15 Hours, 13 Minutes Figure 38 3M™ Cycle Programmer...
  • Page 37 5� Select sterilizer Model Select the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series model for the custom cycle ‑ either GS5X or GS8X The custom cycle will only work on the GSX Series sterilizer model for which it was created (ie GS5X cycle cannot be run on a GS8X nor can a GS8X cycle be run on a GS5X) 6�...
  • Page 38 11.5. Defining Set Points for Cycle Stages and Parameters 1151 Preheat Stage • Cycle temperature is the target chamber temperature for the entire sterilization process • Timeout is the maximum time allowed for the chamber and the vaporizer to reach target temperatures Reference the Air Removal Stage for a description of the vaporizer • Hold time is the duration of time to maintain chamber temperature before exiting the Preheat stage 1.
  • Page 39 Steri‑Vac Sterilizer / Aerator GSX Series – Operator’s Manual ™ ™ 1154 Conditioning Stage The Conditioning stage is partitioned into two sequences: RH ramp‑up and RH hold • RH ramp‑up is responsible for increasing the relative humidity (RH) in the sterilization chamber to the target RH • RH hold is responsible for maintaining the programmed RH level for the specified amount of time to ensure the load has sufficient time to absorb water vapor • Relative Humidity (RH) is the target %RH for the Conditioning stage Special product loads or special cycles may require a very low %RH Select No %RH Injection to create a custom cycle where no vaporized distilled water is injected during the...
  • Page 40 *4‑60 catalog number is a custom fill 3M™ Steri‑Gas™ EO Gas Cartridge ** The use of a 4‑100 and 4‑134 catalog number in the GS8X requires a special adaptor For more information, in the US contact 3M Health Care Helpline at 1‑800‑228‑3957 Outside the US contact your local 3M office or to locate your local office go to www3Mcom...
  • Page 41 Steri‑Vac Sterilizer / Aerator GSX Series – Operator’s Manual ™ ™ • RH lower limit is the tolerance on the lowest allowable percent just prior to puncturing the Steri‑Gas EO Gas Cartridge If the %RH falls below the programmed tolerance, the GSX Series sterilizer will automatically cancel the cycle and proceed to EO Removal, Flushing and Locked Aeration (if programmed) before the user can access the chamber • RH upper limit is the tolerance on the maximum allowable %RH just prior to puncturing the Steri‑Gas EO Gas Cartridge If the %RH rises above the programmed tolerance, the GSX Series sterilizer will automatically cancel the cycle and proceed to EO Removal, Flushing and Locked Aeration (if programmed) before the user can access the chamber...
  • Page 42 Flushing stage and Aeration stage The preprogrammed cycle parameters for the Flushing stage are the set points that populate the 3M™ Cycle Programmer when creating a new cycle Note: Use of preprogrammed cycle set points for the Flushing stage also requires assessment on each custom cycle for validating that facility procedures meet national, state, and local requirements for short term exposure limits (STELs) and long term exposure limits (LTELs)...
  • Page 43 Steri‑Vac Sterilizer / Aerator GSX Series – Operator’s Manual ™ ™ 10. Air Atmospheric Pressure Admission Hold Time: Top Locked Aeration Time e.g. 7 min 9. Aeration Hold Time: Top e.g. 1 min 6. EO Exposure Vent Vent Vent Rate Rate Rate 7.
  • Page 44 11512 Estimated Total Cycle Time The 3M™ Cycle Programmer will estimate the total cycle time with each set‑point change The estimated total cycle time includes programmed Aeration stage The connection of a 3M™ Abator will add an estimated 25‑50 minutes to the total cycle time during the EO Removal stage which is not included in the 3M Cycle Programmer estimate.

  • Page 45: Sterilizer/Aerator Gsx Series

    11.6. Importing Custom Cycles to the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series Importing custom cycles onto the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series requires a Supervisor PIN 3M Health Care service personnel or authorized 3M service personnel must create the first Supervisor user and PIN on the GSX Series sterilizer. Additional Supervisor users and PINs can be created by established Supervisors 1�...
  • Page 46 3� Before a USB drive is detected, all functionality buttons on this screen will be disabled (gray) (Figure 53) Once the USB drive is detected, the functionality buttons will turn blue 4� Press the blue Browse button to search for valid Folders on the USB drive Choose the desired USB folder by pressing the folder name, then OK (Figure 53) 22.2 98.0 04/20/2015...
  • Page 47 Steri‑Vac Sterilizer / Aerator GSX Series – Operator’s Manual ™ ™ Once a cycle(s) has been selected for import, the file(s) will move to the right hand window A green check mark indicates that selected cycles are new to the GSX Series sterilizer and are ready to be imported (Figure 55) Press Import cycles to import The check mark will be removed upon successful import;...

  • Page 48: Sterilizer/Aerator Gsx Series

    • This feature allows custom cycles to be stored and accessed in different locations on the GSX Series sterilizer to help assure Operator selects and starts the correct cycle for the intended application • Minimum aeration times can not be changed in this view for custom cycles Minimum aeration times must be changed in the 3M™ Cycle Programmer and then imported back to the GSX Series sterilizer 22.2...

  • Page 49: Sterilizer/Aerator Gsx Series

    11.8. Managing Custom Cycles on the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series Only one cycle with the same name can be loaded onto the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series The GSX Series sterilizer will check the cycle names before allowing the cycles to be imported If a custom cycle has the same name as a cycle already on the GSX Series sterilizer there are four choices:...

  • Page 50: Sterilizer/Aerator Gsx Series With The Same Name

    11.9. Replacing Cycles on the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series With the Same Name Figure 59 illustrates that the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series has detected a custom cycle to be imported has the same name as a cycle already on the GSX Series sterilizer The sterilizer requests confirmation to replace the custom cycle on the sterilizer...

  • Page 51: Sterilizer/Aerator Gsx Series

    11.10. Removing Custom Cycles from the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series 1� To remove a custom cycle on the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series, the cycle can be deleted with the Delete cycle button and/or the cycle can be copied to a USB drive To copy to a USB drive, place a USB drive into one of the GSX Series sterilizer USB ports...

  • Page 52: 11�11� Cycle Reports

    11.11. Cycle Reports 11111 Custom Cycle Set Points The 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series allows users to view and print parameter values for custom cycles installed on the GSX Series sterilizer The report will display programmed custom cycle set‑points for each parameter 1� To view or print custom cycle set points go to Menu>Reports>Custom cycle set points 2�...
  • Page 53 11112 Export Cycle Data The 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series allows Supervisors or Service to export one or more condensed cycle data files to a USB drive The GSX Series sterilizer can export up to 100 of the most recent cycle data files within 60 minutes The sterilizer also automatically keeps the last 100 condensed cycle data files in a read‑only folder accessible on the sterilizer’s local area network (LAN) by Supervisor or higher access level users...

  • Page 54: Medical Device Packaging And Loading

    12 Medical Device Packaging and Loading 12.1. Preparing Medical Devices for Sterilization For reusable device sterilization, clean devices for sterilizing according to the device manufacturer’s instructions for use before processing in the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series Thorough cleaning is essential to achieve sterilization efficacy DANGER: To reduce risks associated with exposure to ethylene oxide: For reusable device sterilization, always follow the device manufacturer’s instructions for use (IFU), including device cleaning, drying, packaging, sterilizing, and aerating...

  • Page 55: Gsx Series

    CAUTION: To reduce the risk of injury, follow good ergonomic practices Loading baskets should not be overfilled requiring excessive force in pulling and pushing loaded baskets in and out of the 3M™ Steri‑Vac™ Sterilizer/ Aerator GSX Series chamber Reference facility policies and procedures for appropriate ergonomic practices CAUTION: To reduce patient risks associated with exposure to potentially non‑sterile devices or inadequate sterilization procedures:...
  • Page 56 1231 Loading Recommendations 3M™ Attest™ Biological Indicator in a routine biological indicator process challenge device (PCD, also known as a Test Pack or BI PCD) should be used in every load A BI PCD should be placed in the center of the load (Chapter 14: Process Monitoring, Load Release, and Sterilizer Qualification) • Always use loading baskets when loading the 3M™ Steri‑Vac™...

  • Page 57: Operating Instructions

    13.1. Starting a Cycle The Operator controls the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series via a touch screen A fingertip, stylus, or ball tip pen can be safely used to navigate the touch screens There are seven (7) programming steps to start a cycle...
  • Page 58 The minimum default aeration time can be changed for the validated preprogrammed GSX 38C and GSX 55C cycles Minimum aeration times cannot be changed in this view for custom cycles, however, additional aeration time can be added for custom cycles Custom cycle minimum aeration times must be changed in the 3M™ Cycle Programmer and imported back to the GSX Series sterilizer 22.2 98.0...
  • Page 59 WARNING: To reduce the risks associated with fire and explosion, use care when handling 3M™ Steri‑Gas™ EO Gas Cartridges as they contain 100% Ethylene Oxide (EO) which is an extremely flammable gas and liquid under pressure Do not use near flame, electrical sparks, or hot surfaces, or allow sources of ignition near the cartridges Do not puncture cartridge outside the sterilization chamber Do not incinerate cartridges Exposure to temperatures above 150ºF (655ºC) may cause cartridges to burst...
  • Page 60 To scan, place the barcode under the red light of the cartridge scanning bay on the front of the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series (Figure 69) The barcode scanner will remain active for 10 seconds once scanning begins After a successful scan, the 3M™ Steri‑Gas™ EO Gas Cartridge lot number will appear in the cycle parameters section of the GSX Series sterilizer display screen...
  • Page 61 If a valid Steri‑Gas EO Gas Cartridge has a damaged barcode, the Operator has the option to bypass the scan However THIS OPTION CAN ONLY BE PERFORMED FIVE TIMES, after which a 3M Health Care service personnel or authorized 3M service personnel must be contacted to re‑set the override (Figure 71) 22.2...
  • Page 62 5. Insert 3M™ Steri‑Gas™ EO Gas Cartridge, Load Chamber, and Close Door Insert the 3M™ Steri‑Gas™ EO Gas Cartridge into the cartridge bay located inside the GSX Series sterilizer chamber (Figures 73) Push the green lever down over the Steri‑Gas EO Gas Cartridge to secure in place (Figure 74) 22.2...
  • Page 63 Steri‑Vac Sterilizer / Aerator GSX Series – Operator’s Manual ™ ™ Figure 73 Steri‑Gas EO Gas Cartridge in Cartridge Bay Figure 74 Green Lever Securing Steri‑Gas EO Gas Cartridge Insert the load into the GSX Series sterilizer chamber Close the sterilizer door by gently pressing the door to the chamber seal The sterilizer will engage a physical latch to secure and lock the door Press Next to continue A green filled cartridge icon will appear in the cartridge bay area of the sterilizer image on the display screen...
  • Page 64 6. Enter Operator ID (Optional) The Operator ID is optional The Operator ID can be a combination up to 20 characters The system will accept ‘A –Z’ , ‘a‑z’ , 0‑9 space, period, and dash (“‑“) Caps lock can be activated by double tapping the shift (up arrow) button Touch the white data entry field to activate the keyboard then enter the Load ID (Figures 75 and 76) Press Next to continue 22.2 98.0 04/20/2015...
  • Page 65 DANGER: To reduce the risks associated with exposure to ethylene oxide, call 3M Health Care service personnel or authorized 3M service personnel immediately if there is a failure of the display or backlight and the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series continues to operate CAUTION: To reduce patient risks associated with exposure to potentially non‑sterile devices or inadequate sterilization procedures,...

  • Page 66: 13�2� Display Screen Indications

    Error Message. Indicates a fault has occurred See Chapter 16: Cautions, Error Messages and Troubleshooting for specific errors and corrections Indication that a used 3M™ Steri‑Gas™ EO Gas Cartridge is in the chamber Indication that an unused 3M™ Steri‑Gas™ EO Gas Cartridge is in the chamber Counter.

  • Page 67: (Eo) Sterilization Cycle

    1331 Cycle Stages and Descriptions 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series ethylene oxide (EO) sterilization cycles consist of ten stages After the sterilization cycle is complete, an aeration cycle is required to remove any residual EO from the medical devices per the manufacturers’ instructions for use (IFUs) While a sterilization cycle is running, icons on the bottom of the display screen indicate the current stage of the cycle (both with a white box around them and in the stage indicator) Each icon, and the corresponding sterilization cycle stage, is described below...
  • Page 68 1332 Cycle Reports There are five (5) standard sections of a cycle report: Header, Graph, Table, Set‑points, and Footer The contents for each of the five report sections are illustrated in Figures 80 ‑ 84 There are three options for assembling a cycle report: Graph, Table and Detailed Table 6 explains the sections included in each cycle report option Header Graph Table...
  • Page 69 Steri‑Vac Sterilizer / Aerator GSX Series – Operator’s Manual ™ ™ minutes Figure 81 Example Cycle Report – Graph Option Stage Start time Tc (C) Tm (C) Tld (C) Tmd (C) Tul (C) Pc (kPa) Pm (kPa) HS (C) RHc (%) RHm (%) Preheat 03:10:05 21.2 21.2...
  • Page 70 Set-points Cycle complete 55.0 °C Temperature: 0 min Preheat: No errors 16.0 kPa Air removal: No cautions 0.3 kPa / min Chamber test rate: 30 min Conditioning: End time: 04/20/2015 21:03:12 16.0 kPa EO injection: RH end of conditioning: 1:00 hh:mm EO exposure: Temp end of 55.0°...

  • Page 71: Eo Gas Cartridges

    The 3M™ Steri‑Vac™ Sterilizer/Aerators GSX Series software application will introduce a minimal amount of active network traffic when connected to a local area network (LAN) Adding the GSX Series sterilizer to a LAN allows the ability for 3M Health Care service personnel or authorized 3M service personnel to map to read‑only, shared network folders on the sterilizer from a client workstation within the LAN to access diagnostic information The GSX Series sterilizers allow users with Supervisor or Service level access (already set up on the sterilizer) to map to read‑only,...
  • Page 72 The system does not allow execution of unknown applications or applications with uncertified modules The system automatically loads the 3M application on boot up and users are restricted from leaving this application and executing applications that may be vulnerable to malware or viruses System folders on the system that are accessible to the user are read‑only, preventing introduction of malicious applications...

  • Page 73: 13�6� Distilled Water Reservoir

    Inspect the display screen and cycle reports for errors and listen for audible notifications (if enabled)� Always take action for errors as indicated in this manual� Do not attempt to access any internal mechanisms of the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series� Operators should not service the sterilizer as there are no user serviceable parts�...
  • Page 74 3� Open the GSX Series sterilizer door 4� Remove the load from the chamber Remove the empty 3M™ Steri‑Gas™ EO Gas Cartridge 5� Press the Stop button to generate a printout of the cycle report (Figure 89) The display screen will return to the main screen 6�...

  • Page 75: 13�9� Accessing The Chamber - Aeration Not Complete

    13.9. Accessing the Chamber – Aeration Not Complete During user programmed aeration, the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series door can only be opened with a Supervisor PIN (Figures 90 and 91) Aeration timing will be interrupted if the door is opened Once the door is closed and aeration temperature is reached, aeration timing will continue The vent hood (ie exhaust hood) is monitored for appropriate air flow in standard cubic feet per minute (SCFM) If the GXS Series sterilizer detects the air flow is too low, the sterilizer door will remain locked until a minimum of three hours of aeration is fulfilled...

  • Page 76: (Eo) Gas Cartridges

    13.11. Aeration of a Biological Indicator Process Challenge Device (BI PCD) The components of the biological indicator (BI) process challenge device (PCD, also known as a Test Pack) should also be aerated prior to disposal A 3M branded BI PCD will normally be sufficiently aerated with a load with two hours or greater aeration time For other brands of BI PCDs, contact the manufacturer for recommended aeration time Dispose of the BI PCD components per manufacturer’s instructions for use (IFUs)...

  • Page 77: 11�7� Running Custom Cycles On The 3M™ Steri-Vac™ 14 Process Monitoring And Load Release

    • Actual Gas Exposure Time Documentation for physical parameters is provided on the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series cycle reports (printout and electronic file) Under normal operating conditions, the paper cycle report produced at the end of the cycle will be similar to the one shown in Figures 80 ‑ 84 Each cycle report should be reviewed prior to load release per facility policies Critical parameters for the preprogrammed cycles are contained in Table 7 Verification of these parameters on...
  • Page 78 Steri-Vac Sterilizer GS5X-1D Serial number: EA343434 Software version: 1.0.1 Facility: Building 3 Sterilizer ID: Machine 2 Start time: 04/20/2015 05:27:42 Cycle count: Cycle name: GSX 55C Operator ID: Load ID: 120413-1 EO cartridge lot: 2017-02AB Figure 92 Verifying Cycle Report – Header WARNING: To reduce the risks associated with fire and explosion: Inspect the display screen and cycle reports for errors and listen for audible notifications (if enabled) Always take action for errors as indicated in this manual CAUTION: To reduce patient risks associated with exposure to potentially non‑sterile devices or inadequate sterilization procedures:...
  • Page 79 (ie they were killed by the sterilization process) For routine monitoring of the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series EO sterilization process, use 3M™ Attest™ Biological Indicators for EO which contain spores of Bacillus atrophaeus or a biological indicator defined by the user...

  • Page 80: Routine Maintenance

    CAUTION: To reduce patient risks associated with exposure to potentially non‑sterile devices or inadequate sterilization procedures, complete maintenance at routine scheduled intervals of a maximum of every six months There are no user‑serviceable parts; use only 3M Health Care service personnel or authorized 3M service personnel for maintenance 15.1.

  • Page 81: 15�3� Preventative Maintenance

    It is the user’s facility management’s responsibility to complete appropriate decontamination in case of spillage of hazardous material on or inside of the equipment Reference the appropriate Safety Data Sheet (SDS) for decontamination procedures If there are questions regarding the appropriate cleaning procedures and/or cleaning agents, contact your local 3M Health Care service...

  • Page 82: Cautions, Error Messages, And Troubleshooting

    16.1. Caution Messages If the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series detects a fault condition that does not adversely affect the performance of the sterilization cycle, a caution message will appear on both the display screen and cycle report to notify the Operator (Figure 95) The cycle can complete successfully when a caution message is asserted Document all caution messages per facility procedures...

  • Page 83: 16�2� Error Messages

    16.2. Error Messages If the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series detects a fault condition that adversely affects the performance of the cycle, an error message will appear on the display screen and cycle report to notify the Operator Additionally, an optional audible notification will accompany the error message if the audible notification option is enabled Immediately after an error is detected, the sterilization cycle will cancel and the GSX Series sterilizer will automatically complete an error recovery to bring the sterilizer to the safest state possible...

  • Page 84: 16�3� Error Levels And Corrective Actions

    Service must access load and clear error. Document per sensors cannot Service attention is required EO Injection facility procedures Errors that will require 3M Service EO may or may not be − Failure in controller pressure Call Service. present in the chamber Errors that occur during an Error sensor after EO Injection...
  • Page 85 Error Description 3M service personnel Press this button to acknowledge and clear the error Some errors must be cleared by 3M Health Care service personnel or Error Clear Button authorized 3M service personnel with a Service PIN See Table 8 – Descriptions for Error Levels and Corrective Actions for more details...

  • Page 86: Repair And Replacement

    17 Repair and Replacement 3M Health Care has established a worldwide service organization to provide trained technicians to maintain and repair 3M™ Steri‑Vac™ equipment For servicing information or warranty claims in the US, contact the local 3M Service Representative or the 3M Health Care Service Center at the following address: 3M Health Care Service Center...

  • Page 87: Ordering Accessories And Supplies

    24 rolls/case * The use of a 4‑100 and 4‑134 catalog number in the GS8X requires a special adaptor For more information, in the US contact 3M Health Care Helpline at 1‑800‑228‑3957 Outside the US contact your local 3M office or to locate your local office go to www3Mcom...

  • Page 88: Cycle Programmer Support

    Help information is available in the 3M Cycle Programmer application under the Help command Additional assistance is available through 3M For assistance in programming or selecting cycles contact in the US 3M Technical Service – Tech Line at 1 800 441‑1922 Option 2 For assistance in the US on installing the 3M™ Cycle Programmer on a personal computer or network, contact 3M Health Care Service Center at 1‑800‑292‑6298, Option 0 Outside of the US, contact your local 3M office Alternately, send inquires to healthcare@3Mcom...
  • Page 89 3M, Steri‑Vac, Attest, Comply, and Steri‑Gas are trademarks of 3M� Used under license in Canada� © 2015, 3M� All rights reserved� Infection Prevention Division SanDisk and Cruzer are trademarks of 3M Health Care 3M Deutschland GmbH Made in the U�S�A� for SanDisk Corporation, registered in the 3M Center, Building 275‑4E‑01...

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