3M Steri-Vac GSX Series User manual

3M™Steri-Vac™
Sterilizer/Aerator
GSXSeries
Operator’s
Manual

Tableof Contents
Explanation of Symbols....................................................... 2
Product and package labels andpictograms �������������������������2
Explanation of Symbols: OperatorManual������������������������������3
ContentDisclaimers ........................................................... 3
1.Description .................................................................... 4
2. IntendedUse.................................................................. 5
3.Safety ............................................................................ 6
4. Dangers and FirstAid..................................................... 7
4�1�Dangers���������������������������������������������������������������������������7
4�2� FirstAid����������������������������������������������������������������������������8
5.Warnings ....................................................................... 9
6.Cautions ...................................................................... 10
7.Specifications............................................................... 11
7�1� 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series
StructuralSpecifications������������������������������������������������11
7�2� Sound Power Levels Specifications�������������������������������11
7�3� PowerSpecifications�����������������������������������������������������11
7�4� Air SupplySpecifications �����������������������������������������������12
8. Compliance and ReferenceStandards .......................... 12
8�1� Device SafetyCompliance���������������������������������������������12
8�2� Electromagnetic Compatibility (EMC)Compliance���������12
9. Installation and SetUp.................................................. 13
9�1� Environmental OperatingConditions �����������������������������13
9�2� Room and InstallationRequirements�����������������������������14
9�3� Set up andConnections ������������������������������������������������15
10. Using the TouchScreen.............................................. 18
10�1� MainScreen����������������������������������������������������������������18
10�2�Menu���������������������������������������������������������������������������18
10�3�Reports������������������������������������������������������������������������19
10.3.1. CycleReports......................................................19
10.3.2. Ethylene Oxide UsageReports..............................20
10.3.3. Site SetupReport ................................................21
10.3.4. Printer FormFeed................................................22
10�4� CycleCategories����������������������������������������������������������22
10.4.1. OperatorCycles...................................................22
10.4.2. SupervisorCycles................................................23
10�5� SetupMenu�����������������������������������������������������������������24
10.5.1. SiteSetup...........................................................24
10.5.2. UserSetup..........................................................28
10�6�Status��������������������������������������������������������������������������30
10.6.1.Control................................................................30
10.6.2.Info.....................................................................30
10.6.3.Log.....................................................................30
11. 3M™ CycleProgrammer........................................... 31
11�1� 3M™ Cycle ProgrammerOverview ����������������������������31
11�2�3M™ Cycle Programmer Hardware and
SoftwareRequirements�����������������������������������������������31
11.2.1. HardwareRequirements ......................................31
11.2.2. SoftwareRequirements .......................................32
11�3�Installing the 3M™ CycleProgrammer�����������������������32
11�4�Creating a Cycle in the 3M™ CycleProgrammer�������34
11�5�Defining Set Points for Cycle Stages andParameters �37
11.5.1. PreheatStage .....................................................37
11.5.2. Air RemovalStage...............................................37
11.5.3. Chamber TestStage ............................................37
11.5.4. ConditioningStage ..............................................38
11.5.5. EO InjectionStage...............................................39
11.5.6. EO ExposureStage..............................................40
11.5.7. EO RemovalStage...............................................40
11.5.8. FlushingStage ....................................................41
11.5.9. AerationStage ....................................................42
11.5.10. Save a CustomCycle.........................................42
11.5.11.StandbyStage...................................................43
11.5.12.Estimated Total CycleTime................................43
11�6�Importing Custom Cycles to the 3M™Steri‑Vac™
Sterilizer/Aerator GSXSeries���������������������������������������44
11�7� Running Custom Cycles on the 3M™Steri‑Vac™
Sterilizer/Aerator GSXSeries���������������������������������������47
11�8� Managing Custom Cycles on the 3M™Steri‑Vac™
Sterilizer/Aerator GSXSeries���������������������������������������48
11�9�Replacing Cycles on the 3M™Steri‑Vac™
Sterilizer/Aerator GSX Series With 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‑compatiblePackaging ..................................54
12.2.3. Package MedicalDevices ....................................54
12�3� Loading the 3M™Steri‑Vac™ Sterilizer/Aerator
GSXSeries�������������������������������������������������������������������54
12.3.1. LoadingRecommendations..................................55
12.3.2. Loading Medical Devices andInstruments............55
13. OperatingInstructions ................................................ 56
13�1� Starting aCycle �����������������������������������������������������������56
13�2� Display ScreenIndications ������������������������������������������65
13�3� Overview of GSX Series Ethylene Oxide
(EO)SterilizationCycle�������������������������������������������������66
13.3.1. Cycle Stages andDescriptions.............................66
13.3.2. CycleReports......................................................67
13�4�Cartridge Dispose Cycle for 3M™Steri‑Gas™
EOGasCartridges �������������������������������������������������������70
13�5�EthernetConnection����������������������������������������������������70
13.5.1.NetworkConnections ..........................................70
13.5.2.IPAddresses.......................................................70
13.5.3.SoftwareSecurity ................................................71
13.5.4.SoftwareUpdates................................................71
13.5.5.FirmwareUpdates ...............................................71
13�6�Distilled WaterReservoir ���������������������������������������������72
13�7�PrinterOverview����������������������������������������������������������72
13�8�Unloading the 3M™Steri‑Vac™ Sterilizer/Aerator
GSXSeries�������������������������������������������������������������������72
13.8.1. Unloading the 3M™Steri‑Vac™ Sterilizer/Aerator
GSX Series – CycleComplete ..............................73
13�9� Accessing the Chamber – Aeration NotComplete�������74
13�10� Empty 3M™Steri‑Gas™ Ethylene Oxide
(EO)GasCartridges ���������������������������������������������������75
13�11� Aeration of a Biological Indicator Process
ChallengeDevice (BIPCD)�����������������������������������������75
13�12�Sterilization CycleCancellations��������������������������������75
13.12.1. Manual CycleCancellation.................................75
13.12.2. Automatic CycleCancellation.............................75
13�13�PowerOutages����������������������������������������������������������75
14. Process Monitoring and LoadRelease ........................ 76
14�1�Physical Parameters andRequirements����������������������76
14�2� Biological Indicators and Process ChallengeDevices��78
15. RoutineMaintenance ................................................. 79
15�1� DailyCleaning �������������������������������������������������������������79
15�2� Air Supply LineFilters��������������������������������������������������79
15�3� PreventativeMaintenance�������������������������������������������80
16. Cautions, Error Messages, andTroubleshooting.......... 81
16�1� CautionMessages�������������������������������������������������������81
16�2� ErrorMessages �����������������������������������������������������������82
16�3� Error Levels and CorrectiveActions�����������������������������83
17. Repair andReplacement............................................ 85
18. PreventativeMaintenance .......................................... 85
19. Ordering Accessories andSupplies............................. 86
20. 3M™ Cycle Programmer Support
and SoftwareUpdates................................................ 87
ContactInformation��������������������������������������������������������������87
U�S� OrderingInformation�����������������������������������������������������87
Orders for Supplies (e�g� 3M™Steri‑Gas™ EO Gas
Cartridges, 3M™ Attest™ Biological Indicators, 3M™
PrinterPaper)*����������������������������������������������������������������������87

2
3M™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 ‑ Indicates a hazardous situation, which, if not avoided, could resultin death or seriousinjury.
Waste Electrical and Electronic Equipment (WEEE) and EU Battery Directive. This symbol indicates that both the device and lithium ion battery contained therein need to be
disposed ofproperly.
UL Classified to U.S. and Canadian SafetyStandards.
Mark of Conformity to EuropeanDirectives.
Compliant to all applicable ACMA regulatory arrangements(RCM).
Serial number ‑ This symbol is accompanied by the serial number relevant to the device bearing thesymbol.
Catalog ‑ This symbol is accompanied by the catalog 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 withforklift.
Fragile.
Keepdry.
This wayup.
Pictograms are documented according to the European Union (EU) Classification Labeling and Packaging (CLP) Regulation and the Globally Harmonized System (GHS) of Classification and
Labeling ofChemicals.
 Flame ‑ Flammable Gas: Category1
 Skull and Cross Bones ‑ Acute Toxicity (inhalation): Category3
 HealthHazards
Classification Labeling and Packaging (CLP)Regulation
Serious Eye Damage/Eye Irritation, Category 2‑ Eye Irrit. 2;H319
Skin Corrosion/Irritation, Category 2‑ Skin Irrit. 2;H315
Carcinogenicity, Category 1B ‑ Carc. 1B;H350
Germ Cell Mutagenicity, Category 1B ‑ Muta. 1B;H340
Specific Target Organ Toxicity‑Single Exposure, Category 3‑ STOT SE 3;H335

2 3
Globally Harmonized System (GHS) of Classification and Labeling ofChemicals
Specific Target Organ Toxicity (single exposure): Category1
Specific Target Organ Toxicity (repeated exposure): Category1
Specific Target Organ Toxicity (central nervous system): Category3
Carcinogenicity: Category1A
Reproductive Toxicity: Category2
Germ Cell Mutagenicity: Category1B
Eye Irritation: Category2A
Skin Irritation: Category2
Additional pictograms for Globally Harmonized System (GHS) of Classification and Labeling ofChemicals
Gas Cylinder ‑ Gas Under Pressure: LiquefiedGas
The gas cylinder pictogram applies to Globally Harmonized System (GHS) of Classification and Labeling of Chemicals. The gas cylinder is not applicable where the European Union (EU)
Classification Labeling and Packaging (CLP) Regulationapplies.
Exclamation Mark ‑ Irritant, Acute toxicity (harmful) Respiratory Tract,Irritation
The exclamation mark in red border pictogram applies to Globally Harmonized System (GHS) of Classification and Labeling of Chemicals. The exclamation mark in red border is not applicable
where the European Union (EU) Classification Labeling and Packaging (CLP) Regulationapplies.
Explanation of Symbols: OperatorManual
Danger: Indicates 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
PictorialDisclaimer
Sample printouts, graphics, displays and screens are for information and illustration purposes only and shall not be used for clinical or maintenance evaluations. Data shown in sample printouts
and screens do not reflect actual names or testresults.
Hardware Disclaimer
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.
SerialNumber
For easy identification, each 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series has a unique serial number printed on the serial label (e.g. EA343434) found on the right side of the unit and
displayed on the printout for each cycle completed. Record your serial number in this manual for future reference:________________________________.

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3M™Steri‑Vac™Sterilizer / Aerator GSXSeries – Operator’sManual
1.Description
The 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series is for use in industrial sterilization, research, lab, veterinary surgical and other appropriate settings. When installed, operated and maintained
as described in this Operator Manual, the equipment is safe and effective. All Operators must be fully trained in the recommended operation of thisdevice.
The GSX Series sterilizer utilizes an embedded software controlled system to ensure that specified sterilization conditions are met and to minimize the possibility of operator exposure to ethylene
oxide (EO) gas. Use of this equipment in a manner not specified by 3M has not been evaluated and may lead to an unsafecondition.
The GSX Series sterilizer, with the 3M™ Cycle Programmer, provides the user with options to develop optimized and unique EO processes specialized and tailored to the user’s specific product
requirements (e.g. 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.
Alternatively, the user can choose to operate the GSX Series sterilizer by using the two 3M validated preprogrammed sterilizer cycles, GSX 38C and GSX 55C. The user can also choose to
develop a combination cycle containing preprogrammed and customized cycle parameters to meet the configuration of their product design. The GSX Series sterilizer can automatically aerate the
processed load in the sterilization chamber after sterilization. If preferred, the load can be transferred to the 3M™Steri‑Vac™ XL Aerator, aeration cabinet, or aeration 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 preprogrammed cycles, GSX 38C and GSX 55C, that can be selected and used without modification by the end user. The critical sterilization process
set points (e.g. temperature, humidity level, sterilant concentration, exposure time) for these preprogrammed cycles are identical to the critical process set points in the 3M™Steri‑Vac™
Sterilizer/Aerator GS Series, Models GS5and GS8,and have been validated per US FDA Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care
Facilities reference 510(k) number K142034. These critical sterilization process parameters and set points for the preprogrammed cycles are documented in Table1. The end user is responsible
for determining if these preprogrammed cycles are suitable for their specific application, with regards to safety and efficacy, and for any verification or validation documentation required for
theirapplication.
Preprogrammed
Cycle
Process
Temperature (°C)
Process Relative
Humidity %RH EO GasConcentration* (mg/L)
EO ExposureTime
(hour + min)
Aeration
Temp (°C)
Aeration Time
(hours)
GSX 38C 38± 3 40‑ 80
GS5X w/ 4‑100= 735
4.5hr ± 5.4min 38± 3
Programmable
by the Operator
GS5X w/ 4‑134= 934
GS8X w/ 4‑100= 446
GS8X w/ 4‑134= 567
GS8X w/ 8‑170= 759
GSX 55C 55± 3 40‑ 80
GS5X w/ 4‑100= 735
1.0hr ± 1.2min 55± 3
GS5X w/ 4‑134= 934
GS8X w/ 4‑100= 446
GS8X w/ 4‑134= 567
GS8X w/ 8‑170= 759
* EO Gas Concentration is calculated by dividing the 3M™Steri‑Gas™ EO Gas Cartridge nominal fill weight by the 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series chamber volume.
Datasupplied above is based on an emptychamber.
Table1. Preprogrammed Critical Cycle Parameters for GSX SeriesSterilizers

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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
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 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.

6
3M™Steri‑Vac™Sterilizer / Aerator GSXSeries – Operator’sManual
3.Safety
The 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series was developed with the safety of operators and patients in mind. The GSX Series sterilizers are designed with state‑of‑the‑art safety features
thatinclude:
• Hardware and mechanical components of the GSX Series sterilizers meet or exceed the compliance requirements of current, recognized national and international safety standards including
applicable sections of IEC/EN61010‑1, ANSI/AAMI ST24, andEN1422.
• The sterilization process is performed completely under a vacuum. If the system integrity is compromised during ethylene oxide (EO) gas exposure, room air will enter the chamber. In this
situation, the system will detect a rise in pressure and will safely cancel the cycle when the system cannot maintain a vacuum. Sterilization and aeration can be conducted within the same
chamber. Aeration in the sterilization chamber eliminates the need to transfer product loads outside the sterilization chamber when longer aeration times arerequired.
• EO sterilant is delivered in single‑dose cartridges placed inside the sterilization chamber. The use of single‑dose cartridges reduces the risk of leaking ethylene oxide delivery lines and EO
tank changes and provides increased control of sterilantquality.
• GSX Series sterilizers are designed with an internal processor that automatically controls and independently monitors the physical process parameters to ensure sterilization conditions are
maintained throughout the sterilization cycle. The GSX Series sterilizers’ embedded software regulates, independently monitors, and records critical sterilization process parameters including
pressure, temperature, and percent relative humidity (%RH) duringconditioning.
• Automatic fault notification and safe state recovery processes provide additional protection for the Operator. If the GSX Series sterilizer detects a cycle fault, an error message will alert the
Operator. Additionally, an optional audible notification will accompany the error code message. Immediately after detecting a fault, the GSX Series sterilizer will automatically complete an
error recovery process to bring the sterilizer to a safe‑state prior to furtheraction.
• GSX Series sterilizers are designed with a state‑of‑the‑art proprietary humidification process. In the Conditioning stage of the sterilization cycle, GSX Series sterilizers contain a custom
3M designed humidification process that adds, measures, adapts, and controls %RH to accommodate different loads and packaging materials to achieve proper humidification prior to EO
gasinjection.
• Control and monitor sensors detect critical sterilization process parameters. GSX Series sterilizers have control sensors for temperature, %RH, and pressure that provide information to the
control embedded software. The sterilizer has a duplicate set of monitoring sensors that provide independent data and performance monitoring to an independent monitoring processor
during critical sterilization stages for temperature, %RH, andpressure.
• Over‑the‑door vent hood (i.e. 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.
The GSX Series sterilizers and their related devices and accessories are designed to provide safe and reliable service when used according to the provided instructions for use. Please 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 responsibility to ensure that all personnel who operate or maintain the equipment are trained in its operation and safe use. There are no formal safety
inspections required by the Operator. It is the user’s facility management’s responsibility to assure safety inspections are complete. Contact your local 3M Health Care service personnel or
authorized 3M service personnel for required safetyinspections.
The user‘s facility management has the responsibility to provide Operators and staff with the appropriate mitigations for safety regarding the configuration of the process parameters and the
operation of the 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series. These mitigations include end user validation of custom cycles and the identification, training, and use of appropriate protective
measures (e.g. engineering controls, work practices, or personal protective equipment (PPE)); instruction for use of the equipment, with custom process parameters as defined by the end user,
and comprehensive instruction regarding ethylene oxide (EO), including information on relevant health hazards, national regulations, methods for safe use, and methods to detect escape of
theagent.
DANGER: To reduce the risks associated with exposure to ethylene oxide:
Short term exposure limits (STEL) or long term exposure limits (LTEL) or immediately dangerous to life or health (IDLH) levels could be exceeded during NORMAL use. The user’s facility
management is responsible for providing Operators, staff, and personnel working with 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series equipment comprehensive instructions in the process.
This instruction includes information on relevant health hazards.
It is the user’s facility management’s responsibility to ensure that all personnel working with toxic chemicals, gases, and vapors are given comprehensive instruction in their use. This
instruction includes information on relevant health hazards, national regulations, methods for safe use, and methods to detect the escape of the agent.
It is the user’s facility management’s responsibility to ensure regular training of all personnel involved with the operation and maintenance of the equipment, including emergency procedures
for any toxic, flammable, or explosive material released into the environment and to maintain records of attendance and evidence of demonstrated understanding from training sessions.
National regulation regarding limitations on airborne EO concentration in the workplace exist in the United States. Many countries outside of the US have regulations regarding limitations of EO
concentration the workplace aswell.
User’s facility management shall identify and validate appropriate engineering controls, work practices, personal protective equipment (PPE) and training requirements for Operators and staff
prior to running a custom cycle. Prior to the user’s facility management exposure assessment, EO levels may be at or above IDLH (Immediately Dangerous to Life or Health) limits. User’s facility
management shall provide protective measures in accordance with United States 29CFR 1910.134and 29CFR 1910.1047until validation of facility procedures that meet national, state, and
local requirements for short term exposure limits (STELs) and long term exposure limits(LTELs).
Good practice should include a risk analysis of the EO gas sterilization processes, a written Emergency Response Plan, and an Employee Notification plan for EOleaks.
The following warnings and precautions should be observed to avoid unsafe actions that could result in personal injury or damage to theinstrument.

6 7
4. Dangers and FirstAid
DANGER: Potential health effects of ethyleneoxide
Users in the United States must follow the requirements of the United States Occupational Exposure Standard for Ethylene Oxide OSHA (29CFR 1910.1047). 100% ethylene oxide (EO) CAS
number 75‑21‑8is a colorless gas at ambient conditions. Do not rely on sense of smell for the detection of ethylene oxide. EO has a high odor threshold and can only be detected by sense of
smell when it exceeds 500‑ 750parts per million (PPM). EO has a characteristic ether‑like odor (i.e. a sweet and irritating solventsmell).
4.1.Dangers
DANGER: To reduce the risks associated with exposure to ethylene oxide:
Short term exposure limits (STEL) or long term exposure limits (LTEL) or immediately dangerous to life or health (IDLH) levels could be exceeded during NORMAL use. The user’s facility
management is responsible for providing Operators, staff, and personnel working with 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series equipment comprehensive instructions in the process.
This instruction includes information on relevant healthhazards.
Short term exposure limits (STEL) or long term exposure limits (LTEL,) or immediately dangerous to life or health (IDLH) limit could be exceeded during NORMAL use. Operators and
staff must use protective measures (e.g. engineering controls, work practices, or personal protective 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 validating facility protective measures meet
national, state, and local requirements for short term exposure limits (STELs) and long term exposure limits(LTELs).
Ensure Operator selects the correct cycle for the intended application.
Ensure a minimum of ten (10) air exchanges per hour (ACH’s) for the room in which the 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series is installed.
Inspect 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.
For reusable device sterilization, always follow device manufacturer’s instructions for use (IFU), including device cleaning, drying, packaging, sterilizing, and aerating.
Do 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 manufacturer’s instructions for use (IFU) or as programmed by the Operator.
Do not operate the 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series outside specified environmental conditions as stated in this manual.
Only use 3M™Steri‑Gas™ EO Gas Cartridges as listed in this manual. Do not use other brands or types of sterilant cartridges.
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.
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 0.5microns, and that the air supply is free of oil. Ensure that the air filters on the compressed
air supply contain a water trap and are cleaned daily (if applicable) and are properly maintained.
Call 3M Health Care service personnel or authorized 3M service personnel immediately if there is a failure of the display or backlight and the sterilizer continues to operate.
It is the user’s facility management’s responsibility to ensure that all personnel working with toxic chemicals, gases, and vapors are given comprehensive instruction in their use. This
manual includes information on relevant health hazards, national regulations, methods for safe use, and methods to detect escape of the agent.
It is the user’s facility management’s responsibility to ensure regular training of all personnel involved with the operation and maintenance of the equipment, including emergency procedures
for any toxic, flammable, or explosive material released into the environment and to maintain records of attendance and document evidence of demonstrated understanding from training
sessions.

8
3M™Steri‑Vac™Sterilizer / Aerator GSXSeries – Operator’sManual
4.2. FirstAid
Inhalation:
Move person to fresh air and seek medicalattention.
Skin or ClothingContact:
Immediately wash with soap and water. Remove contaminated clothing and wash clothing before reuse. If signs/symptoms develop, seek medicalattention.
EyeContact:
Immediately flush with large amounts of water for at least 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 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).

8 9
5.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
(65.5ºC) may cause cartridge toburst.
3M™Steri‑Gas™ EO Gas Cartridge CatalogNumber 3M™ Steri‑Vac™ Sterilizer GSX SeriesModel Nominal Net Weight of Ethylene Oxide(EO)
4‑100 GS5X or GS8X EO net wt. 100g. (3.52oz.)
8‑170 GS8X EO net wt. 170g. (5.99oz.)
4‑134 GS5X or GS8X EO net wt. 127g. (4.47oz.)
4‑60 GS5X or GS8X Custom EO net wt.
Do not sterilize devices with energy sources which could create a spark in the sterilization chamber during the sterilization cycle.
For reusable device sterilization, always follow device manufacturer’s instructions 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 sterilizer as there are no user
serviceable parts.
WARNING: To reduce the risk of shock due to hazardous voltage:
Do not attempt to access any internal mechanisms of the 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series. Operators should not service the GSX Series sterilizer as there are no user
serviceable parts.
Customer must provide a properly grounded outlet (an earth ground) for installation as described in the installation requirements section of this manual.
Do not operate the 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series outside the environmental conditions as stated in this manual.
Use only 3M Health Care service personnel or authorized 3M service personnel for installation and maintenance.
Do not modify any part of 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series.

10
3M™Steri‑Vac™Sterilizer / Aerator GSXSeries – Operator’sManual
6.Cautions
CAUTION: To reduce the risk of injury:
Always follow the procedures described in this manual.
Follow good ergonomic practices. Loading baskets should not be overfilled requiring excessive force in pulling and pushing loaded baskets in and out of the sterilizer 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:
The user must validate the sterile efficacy of each custom cycle intended to sterilize products that are labeled as ‘Sterile’.
Ensure Operator selects the correct cycle for the intended application.
Inspect 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.
Always use chemical indicators and biological indicators for monitoring the performance of sterilization cycles as described in this manual. Always use chemical indicators and biological
indicators per the device manufacturer’s instructions for use (IFU).
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.
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), including device cleaning, drying, packaging, sterilization, and aeration.
Do not overload the sterilization chamber. Use good practices for loading the sterilizer chamber.
Sterilize only medical devices manufactured with materials compatible with ethylene oxide (EO) sterilization processes. Do not sterilize leather, liquids, or materials reactive to EO.
Only use 3M™Steri‑Gas™ EO Gas Cartridges as listed in this manual. Do not use other brands or types of sterilant cartridges.
Do not force the 3M™Steri‑Gas™ EO Gas Cartridges into the cartridge holder. Excessive force could damage the cartridge and result in a cartridge leak.
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.
Do not modify any data or records from the sterilizer system which may lead to misinterpretation of physical monitor results.
Do not place any device emitting strong electronic magnetic fields (EMFs) near the sterilizer.

10 11
7.Specifications
7.1. 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series StructuralSpecifications
GS5X GS8X
Operational Weight 127kg (281lbs.) singledoor
132kg (290lbs.) double door
261kg (576lbs.) singledoor
269kg (593lbs.) double door
Exterior Dimensions H 70.9cm x W 76.2cm x D 95.0cm
H 27.9in. x W 30.0in. x D 37.4in.
H 179.8cm x W 94.0cm x D 109.0cm
H 70.8in. x W 37.0in. x D 42.9in.
Chamber Internal Volume 136L (4.8cubic feet) 224L (7.9cubic feet)
Chamber Internal Dimensions H 38.0cm x W 43.0cm x D 83.0cm
H 15.0in. x W 17.0in. x D 32.5in.
H 46.0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 patient risks associated with exposure to potentially non‑sterile devices or inadequate sterilization procedures,
do not place any device emitting strong electronic magnetic fields (EMFs) near the sterilizer.
Electrical Power Operating Condition Units
Voltage Range 200‑ 240 VAC
Frequency 50/60 Hertz
Phase Single Not Applicable
GS5X Current 7Amps
GS8X Current 12 Amps

12
3M™Steri‑Vac™Sterilizer / Aerator GSXSeries – Operator’sManual
7.4. Air SupplySpecifications
DANGER: To reduce the risks associated with exposure to ethylene oxide,
ensure that the compressed air supply is clean, with a maximum allowable dirt particle size of 0.5microns, and that the air supply is free of oil. Ensure that the air filters on the compressed
air supply contain a water trap and are cleaned daily (if applicable) and are properly maintained.
Air Supply Feature Specification
Pressure 7.0kg/cm2(100psig) minimum to 10.5kg/cm2(150psig) maximum
Flow Rate 2.2liters per second at 5.3kg/cm2(4.7standard cubic feet per minute at 75psig) per sterilizer based on 100% duty cycle compressor
Quality Clean air supply with a maximum allowable dirt particle size of 0.5microns and free of oil
Moisture Content Less than 10°C (50°F) dew point
8. Compliance and ReferenceStandards
8.1. Device SafetyCompliance
Ethylene oxide (EO) sterilizers, for use in industrial applications, (i.e. outside a health care facility) are not regulated as medical devices by the United States FDA; therefore, they are not eligible for
510(k) review andclearance.
The 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series complies with the following standards as demonstrated by the CB Scheme Certificate and test report issued by the Underwriters
Laboratories(UL):
• IEC / EN 61010‑1(2001) Safety requirements for electrical equipment for measurement, control, and laboratory use ‑ Part 1: Generalrequirements.
• IEC / EN 61010‑2‑010(2003) Safety requirements for electrical equipment for measurement, control and laboratory use ‑ Part 2‑010: Particular requirements for laboratory equipment for
the heating ofmaterials.
• IEC / EN 61010‑2‑040(2005) Safety requirements for electrical equipment for measurement, control, and laboratory use ‑ Part 2‑040: Particular requirements for sterilizers and
washer‑disinfectors used to treat medical devices. The following clauses were not evaluated as part of the IEC 61010‑2‑040: Clause 13.1, 13.1.101.2, 13.1.101.4, 13.1.102, 13.1.103.2,
13.1.103.3,13.101.
The 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series is listed as Laboratory 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™ 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.
In the European Union, the 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series are certified as exempt from the scope of the ATEXDirective.
8.2. Electromagnetic Compatibility (EMC)Compliance
The 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series complies with the following EMC standards as confirmed in the Certificate of Compliance generated by3M:
IEC 61326‑1Electrical equipment for measurement, control and laboratory use ‑ EMC requirements ‑ Part 1: Generalrequirements.
The 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series complies with the EMC requirements of the CE mark EMC Directive2004/108/EC.
The 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series complies with the Australian EMC requirements as confirmed in the Supplier’s Declaration of Conformity that is linked to the RCMMark.
Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15of the FCC Rules. These limits are designed to provide a reasonable
protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates and can radiate radio frequency energy; and, if not
installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause
harmful interference in which case the user will be required to correct the interference at his/her own expense. In addition, operation of this device must accept any interference received,
including interference that may cause undesiredoperation.
This Class A digital equipment meets all requirements of the Canadian Interference‑Causing EquipmentRegulations.

12 13
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(www.3m.com)
WARNING: To reduce the risk of shock due to hazardous voltage,
only use 3M Health Care service personnel or authorized 3M service personnel for installation and maintenance.
9.1. Environmental OperatingConditions
DANGER: To reduce the risks associated with exposure to ethylene oxide,
do not operate the 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series outside the environmental conditions as stated in this manual.
WARNING: To reduce the risk of shock 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 manual.
Environmental Condition Operating Condition Units
Altitude 2500(max) Meters
*Operating Temperature 15‑ 35 ºC
Operating Relative Humidity 20‑ 80(non‑condensing) %RH
Installation/ Transient Over Voltage Category II
Pollution Degree 2
*Note: Operating the 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series in a temperature environment that is close to the sterilization process temperature set point (e.g. 35ºC operating
environment and a 38ºC sterilization process temperature set point) may result in a temperature fault during the sterilizationprocess.

14
3M™Steri‑Vac™Sterilizer / Aerator GSXSeries – Operator’sManual
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.
Room Size Greater than 30m3(1,000ft3)
Spacing Allow 51cm (20inches) of clearance 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 sterilizer Operator. See Figure2.
Exhaust
ACCEPTABLE
Exhaust
or
Sterilizer
Air flow washes entire room.
Air movement is away from operator.
Intake
Exhaust
Intake
UNACCEPTABLE
Sterilizer
“Dead” Air Space
Air movement is toward operator
and “dead” air spaces can form.
Figure2.
Acceptable and Unacceptable Installation AirFlow

14 15
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
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 Connections ‑
3M™Steri‑Vac™ Sterilizer/
Aerator GSXSeries

16
3M™Steri‑Vac™Sterilizer / Aerator GSXSeries – Operator’sManual
7. Vent HoodExhaust
Figure5.
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
WaterReservoir
10. EO Gas Cartridge
BarcodeScanner Figure7.
Front Panel, 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series,
ModelGS5X

16 17
Connection or
Component
Number
Connection orComponent
Name Connection or Component Description
1Power Cord Use the supplied power cord for connection of the system to a properly grounded outlet as specified in the 3M™Steri‑Vac™ Site
Planning and Installation Guide. Ensure there is adequate space at installation to disconnect the power cord whenrequired.
2Power Switch
The power switch turns power to the GSX Series sterilizer OFF and ON. The switch is intended to remain ON at all times in order
to simplify operation and to allow the sterilizer electronics to continually monitor sterilizer functions. It is recommended to keep the
power ON at all times unless otherwise instructed by 3M Health Care service personnel or authorized 3M servicepersonnel.
3Ethernet
The Ethernet connection is not required for normal operation of the system. Connecting to Ethernet provides 3M Health Care Service
with a means to access Service diagnostic information on the GSX Series sterilizer from a desktop computer located on‑site within
the clinic network. 3M Health Care Service can access cycle information, reports (e.g. calibration, site setup) and service diagnostic
information directly on the sterilizer. Devices connected to the Ethernet port must be 60950‑1(General Requirements for Information
Technology Safety) compliant. Do not connect devices that are not compliant to 60950‑1. Reference Chapter13for additional
information.
4Abator
The Abator connection is only provided for connection to an emission control device (i.e. an EO Abator), only if such a device is
required by local laws/codes. Do not connect any other device to this connector. Abator connection is for sterilizer communication
to an emission control device. Abator installation may be optional and not required for the normal operation of the system but is
required in some localities. The Abator connection is intended to only be made by 3M Health Care service personnel or authorized
3M service personnel during installation.
5Air Inlet 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
personnel or authorized 3M service personnel.
6ChamberExhaust
(EthyleneOxide VentLine)
Connect the GSX Series sterilizer to a dedicated vent line in order to exhaust ethylene oxide (EO) to the outside atmosphere
or to an emission control device, an EO Abator. The requirements for venting the sterilizer must be met as documented in the
3M™Steri‑Vac™ Sterilizer/Aerator GSX Series Site Planning and Installation Guide and is intended to be made only by 3M Health
Care service personnel or authorized 3M service personnel.
7Vent Hood Exhaust
The over‑the‑door vent hood (i.e. exhaust hood) supplements 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 rate. If the sterilizer
detects the air flow is too low (< 125SCFM) through the vent hood, the sterilizer door will remain locked until a minimum of three
(3) hours of aeration is fulfilled. Monitoring of the vent hood air flow is optional and can be disabled by an authorized 3M service
provider in the Site Setup<Setup Tab ‑ Options Set (Figure24. Chapter10). If vent hood monitoring is disabled, there will be
no caution message if the air flow SCFM is too low (< 125SCFM) and the sterilizer door will remain locked until a minimum of
three(3)hours of aeration is fulfilled.
8User Screen User and display screen for the Operator interface with the sterilizer control features. See Chapter10for more details.
9USB Ports
The USB ports are available for Universal Serial Bus (USB) drives to export multiple types of cycle reports, sterilizer and cycle
settings, and to load and remove custom cycles programmed on the 3M™ Cycle Programmer. See Chapter11for more details.
Recommended USB drives 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 and importing data and cycles, are to be connected to the USB
ports. Do not connect external USB devices that supply power. See Chapter11for more details.
10 3M™Steri‑Gas™ EO Gas
Cartridge Barcode Scanner
Location of cartridge scanner bay. Scanning the 3M™Steri‑Gas™ EO Gas Cartridge bar code ensures that the cartridge is valid for
use. See Chapter13for more details.
11 Printer w/ Paper
The built‑in printer provides easy‑to‑read information for each sterilization cycle. The printer can also be used to print multiple types
of cycle reports, in addition to sterilizer and cycle settings. The cycle report printout is essential in analyzing the GSX Series sterilizer
performance and can be retained to meet cycle verification policies. See Chapter13for more details.
12 Distilled Water Reservoir
Distilled water is used for humidification of the EO sterilization process. Ensure the distilled water reservoir is adequately filled. The
GSX Series sterilizer will display an error message if the distilled water level is too low to run a sterilization cycle. Do not overfill water
reservoirs.
Not Numbered
Location of the temperature
sensor used for
processcontrol
The temperature sensor used for process control is located inside the sterilizer chamber, protruding from the right side chamber wall
bottom section, towards the loading chamber door.
Table2. Sterilization Connection and ComponentExplanations

18
3M™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.
Sterilizer
22.2
˚
C
98.0
kPa
Open door
Menu
Menu
04/20/2015
05:19:51
65432
17
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
65432
17
Select cycle:
GSX 38C
GSX 55C
Reports
Cycles
Setup
Status
Service
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05:19:52
Figure9.
GSX Series Sterilizer MenuOptions

18 19
10.3.Reports
The 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series has a variety of reporting options as shown in Figure10.
Sterilizer
22.2
˚
C
98.0
kPa
Open door
Menu
Menu
65432
17
Select cycle:
GSX 38C
GSX 55C
04/20/2015
05:19:53
Cycle reports
EO usage report
Site setup report
Custom cycle set points
Export cycle data
Printer form feed
Reports
Cycles
Setup
Status
Service
Figure10.
ReportsMenu
10.3.1. CycleReports
Figure11outlines the options for 3M™Steri‑Vac™ Sterilizer/Aerator GSX Series CycleReports.
Sterilizer
22.2
˚
C
04/20/2015
12:29:13
98.0
kPa
Print or export report
Print selected cycle
Export selected cycle
Export all cycles
Pressure
Relative humidity
Pressure
Relative humidity
Monitor sensorsControl sensors
Temperature
Report format
OK
OK
Return
Return
Enter Pin
Enter Pin
Temperature
Graph
Cycle 33 - 4/20/2015 - Stent 126
Cycle 32 - 4/20/2015 - Stent 126
Cycle 31 - 4/19/2015 - Stent 126
Cycle 30 - 4/19/2015 - Stent 126
Cycle 29 - 4/18/2015 - Scope 395
Cycle 28 - 4/17/2015 - Scope 395
Cycle 27 - 4/17/2015 - Scope 395
Cycle 26 - 4/16/2015 - GSX 55C
Cycle 25 - 4/16/2015 - GSX 55C
Figure11.
Cycle ReportSetup
Reports from the last 100cycles can be printed or exported electronically to a USB drive. When the 100cycle limit is reached, the oldest cycles are replaced with the most recently run cycles.
Select the desired cycle(s) from the list of the last 100cycles (sorted 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. Recommended USB drives include those with FAT32formatting.
USBdrives with pre‑loaded software (e.g. SanDisk’s Cruzer®) are not recommended. Connect only USB drives for the export of data to the USB ports. Do not connect external USB devices that
supply power to the USBports.
Select the cycle(s) for which you wish to export reports and press the OK button. The selected reports are stored in the USB directory selected by the user. The sterilizer will ask for confirmation
of the Folder designation before export. The electronic reports are generated in color and are sized as 20.3cm (8in.) x 27.9cm (11in.) images and contain the same information as the strip
chartreports.
The GSX Series sterilizer has control sensors for temperature, %RH, and pressure that provide information to the control embedded software. In addition, the sterilizer has a duplicate set of
monitoring sensors that provide independent data and performance monitoring during critical sterilization stages for temperature, %RH, and pressure. The sterilizer defaults to report only on the
control sensors. Monitoring sensors can be selected for reporting in the Cycle Report options screen in Figure11.