3M Steri-Vac GSX Series - Description

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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