3M Steri-Vac GSX Series Operator'S Manual Download Page 6 | Manualshive

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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

Time

Atmospheric Pressure

1. Chamber

Preheating

2. Air

Removal

3. Chamber

Test

4. Conditioning

5. EO

Injection

6. EO Exposure

7. EO

Removal

8. Flushing

9. Aeration

10. Air

Admission

P

ressur

e

Figure 1

Pressure Profile GSX Series Sterilizer EO Sterilization Cycle

2 Intended Use

The 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series is intended for the development and validation of ethylene oxide (EO) sterilization process parameters used in product development and

manufacturing and for routine sterilization of products that require 100% ethylene oxide sterilization in the manufacturing process The GSX Series sterilizer is not intended for use in health

care facilities
Always obtain, understand, and follow national and local regulations before installing a GSX Series sterilizer

CAUTION: To reduce the risk of injury,

always follow the procedures described in this manual

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Summary of Contents for Steri-Vac GSX Series

Page 1: ...3M Steri Vac Sterilizer Aerator GSX Series Operator s Manual ...

Page 2: ...Vac Sterilizer Aerator GSX SeriesWith the Same Name 49 11 10 Removing Custom Cycles from the 3M Steri Vac Sterilizer Aerator GSX Series 50 11 11 Cycle Reports 51 11 11 1 Custom Cycle Set Points 51 11 11 2 Export Cycle Data 52 12 Medical Device Packaging and Loading 53 12 1 Preparing Medical Devices for Sterilization 53 12 2 Packaging Medical Devices 53 12 2 1 Recommended Packaging 53 12 2 2 Non co...

Page 3: ...alog number relevant to the device bearing the symbol Authorized representative for the European Community This symbol is accompanied by the name and the address of the authorized representative in the European Community Manufacturer This symbol is accompanied by the name and address of the manufacturer Date of Manufacture This symbol is accompanied by the date of manufacture Do not top load Lift ...

Page 4: ...tes a hazardous situation which if not avoided will result in death or serious injury Warning Indicates a hazardous situation which if not avoided could result in death or serious injury Caution Indicates a hazardous situation which if not avoided could result in minor or moderate injury NOTICE Indicates a hazardous situation which if not avoided may result in property damage Content Disclaimers P...

Page 5: ...on room for aeration thereby releasing the sterilizer for the next load The 3M Cycle Programmer operates on an independent PC computer supplied by the user Custom cycles are created within the 3M Cycle Programmer and are imported to the GSX Series sterilizer from a USB drive The 3M Cycle Programmer will not function directly on the GSX Series sterilizer The GSX Series sterilizer contains two prepr...

Page 6: ...Time Atmospheric Pressure 1 Chamber Preheating 2 Air Removal 3 Chamber Test 4 Conditioning 5 EO Injection 6 EO Exposure 7 EO Removal 8 Flushing 9 Aeration 10 Air Admission Pressure Figure 1 Pressure Profile GSX Series Sterilizer EO Sterilization Cycle 2 Intended Use The 3M Steri Vac Sterilizer Aerator GSX Series is intended for the development and validation of ethylene oxide EO sterilization proc...

Page 7: ...ase read understand and follow all safety information contained in the instructions for use prior to using a sterilizer Use this equipment only for the purpose described in this Operator Manual Retain these instructions for future reference If this equipment is used in a manner not specified the protection provided by the equipment may be impaired It is the user s facility management s responsibil...

Page 8: ...not overload the sterilization chamber Use good practices for loading the sterilizer chamber Never use force to access the inside of the sterilization chamber Always review the elapsed aeration time on the 3M Steri Vac Sterilizer Aerator GSX Series display prior to opening the sterilizer door Always inspect cycle reports printout or electronic to ensure the total aeration time matches the device m...

Page 9: ...east 15 minutes Remove contact lenses if easy to do so Continue rinsing Immediately seek medical attention If Swallowed Rinse mouth DO NOT INDUCE VOMITING Immediately seek medical attention Hazard statements of ethylene oxide EO Extremely flammable gas Contains gas under pressure may explode if heated Toxic if inhaled Causes serious eye irritation May cause drowsiness or dizziness Suspected of dam...

Page 10: ...tions for use IFU including device cleaning drying packaging sterilization and aeration Inspect display screen and cycle reports for error codes and listen for audible notifications if enabled Always take action with error codes 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 GSX Series ...

Page 11: ...the End of Conditioning Temperature at the End of Conditioning Actual Gas Exposure Time Complete maintenance at routine scheduled intervals of a maximum of every six 6 months There are no user serviceable parts Only use 3M Health Care service personnel or authorized 3M service personnel for maintenance For reusable device sterilization always follow device manufacturer s instructions for use IFU i...

Page 12: ... cm x W 51 0 cm x D 97 0 cm H 18 0 in x W 20 0 in x D 38 0 in 7 2 Sound Power Levels Specifications GS5X GS8X A weighted 85 dBa 85 dBa 7 3 Power Specifications WARNING To reduce the risk of shock due to hazardous voltage the customer must provide a properly grounded outlet an earth ground for installation as described in the installation requirements section of this manual CAUTION To reduce patien...

Page 13: ... Electrical Equipment for Use in Health Care Applications Certified for Canada and carries the UL mark with adjacent indicators C and US based on compliance to the standards UL 61010 1 and CAN CSA 22 2 No 61010 1 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...

Page 14: ...ock due to hazardous voltage do not operate the 3M Steri Vac Sterilizer Aerator GSX Series outside the environmental conditions as stated in this manual CAUTION To reduce patient risks associated with exposure to potentially non sterile devices or inadequate sterilization procedures do not operate the 3M Steri Vac Sterilizer Aerator GSX Series outside the environmental conditions as stated in this...

Page 15: ...rance space at the top rear and sides of the sterilizer for maintenance and service and a minimum of 10 cm 4 inches from the rear wall for single door units Ensure sufficient space Ventilation Negative pressure with a minimum of ten 10 air exchanges per hour The ventilation system should be non recirculating and dedicated Air Flow Air flow washes the entire room Air movement is away from the steri...

Page 16: ...Models GS5X and GS8X Chamber Door Touch Screen Display Water Reservoir Printer USB Ports Access Door Cartridge Scanner Bay Printer USB Ports Access Door Water Reservoir Access Door Figure 3 Front View 3M Steri Vac Sterilizer Aerator GSX Series Models GS5X GS8X 1 Power Cord 2 Power Switch 3 Ethernet optional 4 Abator optional 6 Chamber Exhaust Ethylene Oxide Vent Line 5 Air Inlet Figure 4 Left Side...

Page 17: ...creen 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 Water Reservoir 10 EO Gas Cartridge Barcode Scanner Figure 7 Front Panel 3M Steri Vac Sterilizer Aerator GSX Series Model GS5X ...

Page 18: ... the room s directional air flow and is designed to draw air away from Operators removing a load from the chamber The hood is connected by 3M Health Care service personnel or authorized 3M service personnel to a customer supplied dedicated exhaust system during installation of the sterilizer The vent hood i e exhaust hood is monitored for an adequate standard cubic feet per minute SCFM air flow ra...

Page 19: ...u 04 20 2015 05 19 51 6 5 4 3 2 1 7 Select cycle GSX 38C GSX 55C Figure 8 GSX Series Sterilizer Main Screen 10 2 Menu The Menu button in the bottom left hand corner is used to access the following options Reports Cycles Setup Status and Service Figure 9 shows the Menu options screen Sterilizer 22 2 C 98 0 kPa Open door Menu Menu 6 5 4 3 2 1 7 Select cycle GSX 38C GSX 55C Reports Cycles Setup Statu...

Page 20: ...orted with the most recently run cycles at the top and select the desired function from the following options print selected cycle export selected cycles or export all cycles Only one cycle may be selected for printing Multiple cycles can be selected for export to a USB drive To export electronic reports insert a USB drive data storage device into one of two USB ports on the GSX Series sterilizer ...

Page 21: ... 17 2015 Scope 395 Cycle 26 4 16 2015 GSX 55C Cycle 25 4 16 2015 GSX 55C Graph Figure 12 Selecting Report Formats 10 3 2 Ethylene Oxide Usage Reports Generate a report for ethylene oxide EO usage from the Menu Reports EO Usage Report screen Generate an EO Usage Report for specific dates as illustrated in Figure 13 View the report on the display screen print the report directly from the sterilizer ...

Page 22: ...ve 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 Sterilizer 22 2 C 04 20 2015 12 30 30 98 0 kPa 6 5 4 3 2 1 7 GSX 38C GSX 55C Site setup report Print Print Export Export Cancel Cancel Site setup report EA343434 04 20 2015 12 32 52 Software version 1 0 1 ___________...

Page 23: ...s Export cycle data Printer form feed Reports Cycles Setup Status Service Figure 16 Location of the Printer Form Feed Button 10 4 Cycle Categories There are two categories of cycles standard Operator Cycles and specialized Supervisor Cycles Figure 17 shows the Cycles Options Menu Operator Cycles 10 4 1 Operator Cycles Selecting Operator Cycles allows the Operator Cycles to appear on the Main scree...

Page 24: ...les There are two 2 preprogrammed Supervisor Cycles Aeration and Cartridge Dispose Program each cycle by following the step by step instructions as they appear on the screen 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 G...

Page 25: ... User setup Import export cycles Figure 20 Button to Access Site Setup Options 10 5 1 Site Setup The Site Setup Preferences tab includes the options listed below in Figure 21 The selected options in Figure 21 are the default settings Sterilizer 22 2 C 04 20 2015 12 34 37 98 0 kPa Select cycle temperature 6 5 4 3 2 1 7 55 C 55 C Setup Return Reset Reset Apply changes Preferences Cycle Setup Date Ti...

Page 26: ...nabled the system will maintain user entered target temperature while in Idle mode Off GSX 30 60 C Off Supervisor Pressure unit Allows user to select preferred units for pressure on display and select reports mbar kPa mbar Supervisor User cycle count Will count cycles performed between supervisor access level resets Incremented at start of a cycle 0 2147483647 0 Supervisor Reset to zero only Reset...

Page 27: ...creen Touch row to change values Operator Cycle 2 0 hrs 2 0 hrs Minimum aeration Setup Preferences Cycle Setup Date Time Network Site 55 C Minimum aeration 10 11 12 00 hh mm 30 13 14 OK OK Cancel Cancel GSX 38C GSX 55C Figure 23 Changing the Minimum Aeration Default Time The Site Setup Setup tab Figure 24 provides the specific configuration and maintenance details for your site this is established...

Page 28: ...p Preferences Cycle Setup Date Time Network Site Figure 25 Site Setup Date Time Options The Site Setup Network Figure 26 tab provides the entry point for specific networking codes Refer to the Ethernet connection section of the Operator Manual for more details Sterilizer 22 2 C 04 20 2015 12 42 40 98 0 kPa Select cycle temperature 6 5 4 3 2 1 7 55 C Return Apply changes DHCP IP address Subnet mask...

Page 29: ...ers PINs for Supervisors and Service A Service access level PIN is required to create the first Supervisor user Supervisors can then set up additional Supervisors Only Service can set up additional Service users Figures 28 31 illustrate the use of the User Setup Menu 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 ...

Page 30: ...47 56 98 0 kPa Select cycle temperature 6 5 4 3 2 1 7 CSX 38C CSX 55C Add user User name Access level Return Return Save Save Supervisor Confirm PIN PIN Figure 30 User Setup Menu Adding a Supervisor Sterilizer 22 2 C 04 20 2015 12 48 57 98 0 kPa Select cycle temperature 6 5 4 3 2 1 7 CSX 38C CSX 55C Edit users Larry Service Return Return Add user Add user JohnSmith Supervisor Figure 31 User Setup ...

Page 31: ...u 6 5 4 3 2 1 7 Select cycle GSX 38C GSX 55C Reports Cycles Setup Status Service 04 20 2015 05 19 52 Figure 32 Status Button 10 6 1 Control The Control tab of the Status option provides information on the current state of the 3M Steri Vac Sterilizer Aerator GSX Series sensors valves and software conditions 10 6 2 Info The Info tab of the Status option provides version numbers for 3M Steri Vac Ster...

Page 32: ...on PC User saves custom cycle on USB drive STEP 4 Operator can start custom cycle from Operator Cycle Start Screen STEP 2 User imports custom cycle onto the GSX Series sterilizer using a USB drive Supervisor PIN required STEP 3 Custom cycle is stored in Cycle Setup Menu Supervisor PIN required to move custom cycle to Operator Cycle Start Screen USB Sterilizer 22 2 C 98 0 kPa Open door Menu Menu Se...

Page 33: ...Programmer software 3 Once downloaded double click the 3M_Cycle_Programmer Version exe file to install the application Microsoft NET Framework version 4 0 will be installed by the program if the software does not exist on the user s computer 4 From the drop down box select the desired language for the 3M Cycle Programmer 5 Review the end user license agreement for the 3M Cycle Programmer Check the...

Page 34: ...e xml 6 25 2014 9 23 AM XML Document 2 KB Cancel Open Figure 35 Locating the Saved License xml File License Please select a valid license file Submit Cancel x C Users Desktop License Files Cycle Programmer Figure 36 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 offi...

Page 35: ...th exposure to potentially non sterile devices or inadequate sterilization procedures 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 s...

Page 36: ...porizer temperature Vacuum level Vacuum rate Units 160 100 C mbar 3 Chamber test 6 5 99 Maximum Set Point Minimum Parameter Duration Units min 4 Conditioning 30 90 Maximum Set Point Minimum Parameter Relative Humidity RH Timeout Units 200 min Hold time 0 999 RH injection rate Slow Fast RH lower limit 10 50 RH upper limit 70 90 60 50 30 Fast 10 90 No RH Injection 5 EO injection No 100 Yes Maximum S...

Page 37: ...ence One Column or Two Columns Choose one column to display the cycle stages and parameters in a one column list or choose two columns to display the cycle stages and parameters across two columns Some languages require a one column list display 8 Define the set points for each stage of the ethylene oxide EO sterilization custom cycle Figure 1 is a Pressure Profile of the ten 10 stages of the prep...

Page 38: ...um rate programmed in the Air Removal stage will be applied to all vacuums of the sterilization process Note The Vacuum rate is controlled by the percentage of time the vacuum is applied to the chamber A Vacuum rate set point of 100 is the fastest air removal rate The vacuum is applied to the chamber 100 of the time until the programmed vacuum level is reached The preprogrammed cycle vacuum rate i...

Page 39: ... exiting the Conditioning stage RH injection rate is the time period to allow water vapor to absorb before calculating the next RH injection duration There are three set points fast medium and slow The Fast set point is the preprogrammed setting Medium and Slow set points may be used depending on the absorption characteristics of the load Studies on each load type may be required to optimize the R...

Page 40: ...ly cancel and will proceed to EO Removal Flushing and Locked Aeration if programmed before the user can access the chamber Table 4 is the calculated minimum pressure rise 70 seconds after EO injection for the four available 3M Steri Gas EO Gas Cartridges for each chamber size GS5X and GS8X Calculations are based on nominal fill weights of the Steri Gas EO Gas Cartridges GS5X Nominal Weight of EO g...

Page 41: ...0 No 160 200 40 80 Figure 44 EO Injection Stage 11 5 6 EO Exposure Stage Duration for EO ethylene oxide Exposure is the time period between the end of EO Injection and the beginning of EO Removal when EO is sterilizing the load No other parameters are programmed during the EO Exposure stage 6 EO exposure 60 0 999 Maximum Set Point Minimum Parameter Duration Units min Figure 45 EO Exposure Stage 11...

Page 42: ...00 of the time until the programmed flushing hold time top is satisfied The preprogrammed cycle vent rate is 100 A Vent rate set point of 25 is the slowest rate in which the vent valve is open to chamber 25 of the time until the programmed flushing hold time top is satisfied Hold time Top is the amount of time the vent will remain open while the vacuum draws air through the chamber The Hold time T...

Page 43: ... cycle during cycle start up A Supervisor PIN is required to stop the Aeration stage before the minimum aeration time is complete 9 Aeration 55 12 0 34 0 60 Maximum Set Point Minimum Parameter Aeration temperature Minimum aeration time Units 999 C hr Figure 49 Aeration Stage 11 5 10 Save a Custom Cycle 1 Select File Save or use the Save icon to save the custom cycle 2 Select a Folder location to s...

Page 44: ...stage stops when the chamber door is opened and the red Stop button is pressed The Standby stage should be considered and evaluated during user s facility management exposure assessments developing and validating cycles for sterilization before implementing facility standard operating procedures SOPs for the 3M Steri Vac Sterilizer Aerator GSX Series Time Atmospheric Pressure 10 Air Admission 3 mi...

Page 45: ...ives include drives with FAT32 formatting Drives with pre loaded software e g SanDisk s Cruzer are not recommended Only USB drives for the sole purpose of exporting data are to be connected to the USB ports Do not connect external USB devices that supply power Figure 51 Inserting a USB Drive into the sterilizer USB Port 2 Go to Menu Setup Import export cycles Figure 52 Import export of custom cycl...

Page 46: ... USBDisk Custom Cycles GS5X Export cycles Return Delete cycle Import cycles Cancel Custom Cycles GS5X Choose USB folder then select OK OK Cancel Figure 53 Finding Folders on the USB Drive 5 Custom cycle files in the selected Folder will appear in the left window for the option of importing To import a single file press To import all files press Figure 54 Sterilizer 22 2 C 04 20 2015 14 01 17 98 0 ...

Page 47: ...ht window Figure 56 Sterilizer 22 2 C 04 20 2015 14 03 29 98 0 kPa Stent 126 Scope 395 Import export cycles USB folder Custom Cycles GS5X Cycles on sterilizer USBDisk Custom Cycles GS5X Export cycles Return Delete cycle Import cycles Cancel Figure 55 Custom Cycles Ready for Import Sterilizer 22 2 C 04 20 2015 14 04 04 98 0 kPa Stent 126 Scope 395 Import export cycles USB folder Custom Cycles GS5X ...

Page 48: ... the correct cycle for the intended application 1 A Supervisor must access Menu Site Setup Setup Cycle to enable newly imported cycles on the Operator Cycle Start Screen Newly imported cycles are not automatically added to the Operator Cycle Start Screen view Figure 57 Note Cycles created for the Operator will be selectable in Operator view Cycles created for the Supervisor will be selectable in S...

Page 49: ...rator selects and starts the correct cycle for the intended use 4 Start the cycle per Chapter 13 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...

Page 50: ...Return Delete cycle Import cycles Cancel Scope 395 Replace Scope 395 on sterilizer Cancel OK Figure 59 Example of Replacing a Custom Cycle on the GSX Series Sterilizer 1 To replace the custom cycle on the sterilizer select OK 2 A red X will appear next to the cycle to be deleted and a green check mark will appear next to the cycle to be imported Figure 60 Press Import cycles to proceed 3 Press Ret...

Page 51: ...on the USB drive to store the exported cycle s e g USBDisk Custom Cycles GS5X EA343434 Export cycles Figure 61 4 Select single file for export from the right window and click To export all files click The selected files will move to the left window Figure 61 5 A green check mark next to the file name indicates the custom cycles are ready to be exported Figure 61 Select Export cycles 6 The steriliz...

Page 52: ...ature 60 C 140 F Timeout 60 min Hold time 0 min Stage Air removal Heatsink temperature 95 C 203 F Chamber pressure 160 mbar Duty cycle 100 Stage Chamber test Chamber test time 5 min Stage Conditioning Relative humidity 40 Humidify timeout 50 min Hold time 0 min RH injection rate Fast RH threshold lower 10 RH threshold upper 90 Stage EO injection Simulate EO Yes Inject pressure 160 mbar Minimum pre...

Page 53: ...the USB drive to store the exported cycle s data e g USBDisk Custom Cycles GS5X EA343434 Export cycle data 6 Display screen will display up to 100 stored cycles for selection 7 Choose Export selected cycles or Export all cycles Figure 63 8 Wait momentarily for the export process to complete and then press OK on the Save Completed screen to return to the main screen Sterilizer 22 2 C 04 20 2015 14 ...

Page 54: ...ON To reduce patient risks associated with exposure to potentially non sterile devices or inadequate sterilization procedures For reusable device sterilization always follow device manufacturer s instructions for use IFU including device cleaning drying packaging sterilization and aeration Only sterilize medical devices that are manufactured with materials compatible with ethylene oxide sterilizat...

Page 55: ...d sealed according to the procedures recommended by their respective manufacturers 12 3 Loading the 3M Steri Vac Sterilizer Aerator GSX Series Loading baskets are recommended to facilitate loading the sterilization chamber Loading baskets are designed with skids to avoid scratching the chamber floor A transport cart can be used to easily load unload and move loading baskets to and from the 3M Ster...

Page 56: ...ide EO can circulate freely between them Place peel pouches on their edges if possible Arrange sterilization pouches so that the transparent side of a pouch faces the opaque side of the adjacent pouch Ensure no devices are touching the GSX Series sterilizer chamber walls 12 3 2 Loading Medical Devices and Instruments Sterilization pouches should be placed on their edges if possible If a sterilizat...

Page 57: ...cations 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 inspect the display screen and cycle reports for error codes and listen for audible notifications if enabled Always take action for error codes as indicated in this manual 1 Select Cycle The 3...

Page 58: ...terilizer 22 2 C 98 0 kPa Open door Cycle GSX 55C Menu Menu Back Back Next Next Select aeration time 10 11 12 00 hh mm Continuous 30 13 14 04 20 2015 05 21 01 6 5 4 3 7 1 2 Figure 65 Step Two Select Aeration Time 3 Enter Load ID Optional The Load ID is optional The Load ID can be a combination of up to 20 characters The system will accept A Z a z 0 9 space period and dash Caps lock can be activate...

Page 59: ...uce 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 Exp...

Page 60: ...Cartridge lot number will appear in the cycle parameters section of the GSX Series sterilizer display screen Sterilizer 22 2 C 98 0 kPa Open door Cycle GSX 55C Aeration hh mm 12 00 Load ID 120413 1 Menu Menu Back Back Next Next Scan 3MTM Steri GasTM EO Gas Cartridge barcode 04 20 2015 05 23 35 6 5 4 4 2 3 1 7 Figure 68 Step Four Scan the 3M Steri Gas EO Gas Cartridge Barcode Only valid 3M Steri Ga...

Page 61: ...maged 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 Sterilizer 22 2 C 98 0 kPa Open door Cycle GSX 55C Aeration hh mm 12 00 Load ID 120413 1 Menu Menu Back Back Do not scan Do not scan Rescan Rescan Next N...

Page 62: ... Cartridge Insert load Close door 04 20 2015 05 26 08 6 4 5 2 3 4 1 7 Back Back Figure 72 Step Five Insert Steri Gas EO Gas Cartridge Insert Load Close Door DANGER To reduce the risks associated with exposure to ethylene oxide do not force the 3M Steri Gas EO Gas Cartridges into the cartridge holder as excessive force could damage the cartridge and result in a cartridge leak CAUTION To reduce pati...

Page 63: ...as 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: ...rilizer 22 2 C 98 0 kPa Open door Cycle GSX 55C Aeration hh mm 12 00 Load ID 120413 1 Cartridge lot number 2017 02AB Menu Menu Enter operator ID 04 20 2015 05 27 03 6 4 6 2 3 4 5 1 7 Back Back Touch to enter Next Next Figure 75 Enter Operator ID Sterilizer 22 2 C 98 0 kPa Open door Cycle GSX 55C Aeration hh mm 12 00 Load ID 120413 1 Cartridge lot number 2017 02AB Menu Menu Next Next 04 20 2015 05 ...

Page 65: ... sterilization cycle Figure 78 is the display screen of a cycle in the Preheat stage Stop Sterilizer 25 0 Menu Menu C 04 20 2015 05 28 01 Cycle Count 33 GSX 55C Show chart 84 5 kPa 15 30 Cycle time remaining hh mm Stage Preheat Open door Figure 78 Preheat Stage Display Screen DANGER To reduce the risks associated with exposure to ethylene oxide call 3M Health Care service personnel or authorized 3...

Page 66: ...ons 9 Indication that a used 3M Steri Gas EO Gas Cartridge is in the chamber 10 Indication that an unused 3M Steri Gas EO Gas Cartridge is in the chamber 11 Counter This is the sterilizing cycle counter that indicates the cumulative number of all cycles started including those cycles in which a fault occurred 12 Cycle stage icons While a sterilization cycle is running the icons on the bottom of th...

Page 67: ... During this period the final chamber pressure measurement minus the initial chamber pressure measurement must be less than 18 mBar 1 8 kPa Stage 4 Conditioning The Conditioning stage involves treatment of the product load within the sterilization cycle prior to EO admission in order to attain a predetermined temperature and relative humidity This part of the sterilization cycle is carried out com...

Page 68: ...cluded N A Included Detailed Included Included Included Included Included Reference Section 11 13 for a obtaining a detailed report of set points for custom cycles Table 6 Options for Standard Cycle Reports Navigate to Menu Reports Cycle Reports to save or print a cycle report Note The print record will fade over time Photocopy or electronically export reports for long term storage Steri VacTM Ste...

Page 69: ...0 Tmd C 21 1 53 5 54 0 54 2 54 4 54 4 54 4 54 4 54 5 Pc kPa 97 06 77 49 15 95 16 22 15 38 61 58 60 02 16 79 79 70 HS C 31 0 54 9 94 7 94 7 94 9 61 7 54 9 55 0 54 9 RHc 5 2 59 1 RHm 5 1 56 4 Pm kPa 97 14 77 60 15 98 16 25 15 41 61 64 60 12 16 78 19 85 Tul C 21 1 54 3 54 9 55 1 55 3 558 3 55 2 55 2 55 1 Tld C 21 0 54 2 54 7 54 9 55 1 56 1 55 0 55 0 54 9 Tc C 21 2 54 0 54 6 54 7 55 0 56 0 55 0 55 0 5...

Page 70: ...aining a detailed report of set points for custom cycles The definitions for the column headings in the Table cycle report Figure 82 are as follows Tc C is the chamber temperature C read by the control sensor Tm C is the chamber temperature C read by monitor sensor Tld C is the load zone temperature C of the chamber heating blankets Tmid C is the middle load zone temperature C of the chamber heati...

Page 71: ...sterilizer via a secured Manager Console The device agent also allows 3M to provide software and firmware updates to your system remotely The Operating System OS uses the NDIS Network Device Interface Specification to communicate with the Ethernet hardware TCP IP and DNS protocols are supported Device configuration HTML server has been disabled Access to shared drives is read only The device agent...

Page 72: ...es uploaded from a 3M server if appropriate access to the server through the Ethernet connection is enabled When a pending software update is available the following screen will be displayed Figure 86 The update software prompt will only display when the GSX Series sterilizer transitions to Idle mode Main Screen and no pending errors exist The sterilizer screens will guide the user through the upd...

Page 73: ...ive equipment PPE in accordance with United States 29 CFR 1910 134 and 29 CFR 1910 1047 under NORMAL use conditions until the user s facility management completes an exposure assessment on each custom cycle that validates facility protective measures meet national state and local requirements for short term exposure limits STELs and long term exposure limits LTELs Inspect the display screen and cy...

Page 74: ... to equilibrate to room pressure this typically requires 60 90 seconds 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 Follow the Process Monitoring and Quality Control procedures described in Chapte...

Page 75: ... of aeration is fulfilled 1 To access the chamber when aeration is not complete press the Open Door button on the touch screen On double door units press the Open Unload Door button 2 Enter the Supervisor or Service PIN 3 Close the GSX Series sterilizer door to continue aeration Sterilizer Aeration time elapsed hh mm 0 05 1 00 11 55 55 0 C 04 20 2015 20 56 12 Gas expose time elapsed hh mm Time rem...

Page 76: ...M Steri Vac Sterilizer Aerator GSX Series will automatically proceed to or repeat EO Removal and Flushing stages to clear the chamber of EO gas before the door is unlocked A manual cycle interruption error message will appear on the display screen and cycle reports Refer to Chapter 16 Cautions Error Messages and Troubleshooting for error codes and their respective corrective actions 13 12 2 Automa...

Page 77: ...nditioning 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 ...

Page 78: ...e notifications if enabled Always take action for errors as indicated in this manual Always inspect cycle reports printout or electronic file to ensure the Operator s programmed parameters or the device manufacturer s instructions for use IFU matches RH at the End of Conditioning Temperature at the End of Conditioning Actual Gas Exposure Time For reusable device sterilization always follow device ...

Page 79: ...rocess use 3M Attest Biological Indicators for EO which contain spores of Bacillus atrophaeus or a biological indicator defined by the user 3M Attest Biological indicators for EO comply with applicable clauses of ISO 11138 2 should be placed within an appropriate process challenge device PCD The appropriateness of the BI PCD used for process definition validation or routine monitoring and control ...

Page 80: ...ri Vac Sterilizer Aerator GSX Series daily if applicable Chamber walls and floor Outer lip of the chamber Inside surface of the chamber door Outer surface of the cabinet Door gasket Do not use alcohol or any other anti bacterial cleaning agents as these could damage the door seal gasket and potentially falsely activate an ethylene oxide EO area monitor if installed After cleaning use a clean soft ...

Page 81: ...ice personnel or authorized 3M service personnel for maintenance Sterilizer 22 2 C 98 0 kPa Open door Menu Menu 04 20 2015 05 19 51 6 5 4 3 2 1 7 Select cycle GSX 38C GSX 55C Wrench Icon Preventative Maintenance is Due Figure 94 Wrench Icon Preventative Maintenance is Due It is the user s facility management s responsibility to complete appropriate decontamination in case of spillage of hazardous ...

Page 82: ...dequate sterilization procedures 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 The 3M Steri Vac Sterilizer Aerator GSX Series is designed with embedded software that automatically controls monitors and regulates the mechanical functions of the GSX Series sterilizer and the sterilizat...

Page 83: ...rilization cycle and two error levels that could occur during the Aeration stage The seven error levels descriptions and their respective corrective actions are detailed in Table 8 Some errors must be cleared by your 3M Health Care service personnel or authorized 3M service personnel with a Service PIN Stop Sterilizer Cycle failure Error level 4 recovery 10 30 55 0 Menu Menu C 04 20 2015 06 33 34 ...

Page 84: ...ar the error Wait until the Stop button is red Supervisor or Service press Stop Cycle and enter PIN Supervisor or Service press Clear and enter PIN to clear the error Document per facility procedures L5 Errors that occur after EO is in the chamber Pressure and temperature sensors can return system to a safe state however Service is required to open load door Leak detected in EO Expose stage Punctu...

Page 85: ...rsonnel or authorized 3M service personnel 3 Error Clear Button Press this button to acknowledge and clear the error Some errors must be cleared by 3M Health Care service personnel or authorized 3M service personnel with a Service PIN See Table 8 Descriptions for Error Levels and Corrective Actions for more details 4 Error Additional Details Toggle Button Press toggle button to reveal the Error Le...

Page 86: ...0 292 6298 Fax 1 800 770 8016 In Canada contact 3M Health Care 3M Canada Inc P O Box 5757 London Ontario N6A 4T1 1 800 268 6235 English 1 800 567 3193 French Outside of the U S contact your local 3M Subsidiary for warranty claims or for contacting your 3M Health Care service personnel or authorized 3M service personnel Service Contact 18 Preventative Maintenance 3M provides preventative maintenanc...

Page 87: ... 78 8055 6039 4 1 Basket 3M Steri Gas Ethylene Oxide EO Cartridge Adaptor 78 8083 3965 5 1 Adaptor Name Catalog Number Packaging 3M Steri Gas 100 Ethylene Oxide EO Gas Cartridges 4 134 EO net wt 127 g 4 47 oz 12 units box 3M Steri Gas 100 Ethylene Oxide EO Gas Cartridges 4 100 EO net wt 100 g 3 52 oz 12 units box 3M Steri Gas 100 Ethylene Oxide EO Gas Cartridges 8 170 EO net wt 170 g 5 99 oz 12 un...

Page 88: ... Helpline 1 800 228 3957 www 3M com infectionprevention 3M Health Care 3M Canada Post Office Box 5757 London Ontario N6A 4T1 Canada 1 800 364 3577 www 3M com ca healthcare U S Ordering Information Quotations and Orders for Equipment Service Parts and Accessories 3M Health Care Service Center Telephone Orders 1 800 292 6298 Select 2 Fax Orders 1 800 770 8016 Mail Orders 3M Health Care Service Cente...

Page 89: ...e 2510 Conway Ave St Paul MN 55144 3M Deutschland GmbH Health Care Business Carl Schurz Str 1 41453 Neuss Germany 3M Steri Vac Attest Comply and Steri Gas are trademarks of 3M Used under license in Canada 2015 3M All rights reserved SanDisk and Cruzer are trademarks of SanDisk Corporation registered in the United States and other countries Issue Date 2015 01 34 8716 1208 0 ...

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