3M Steri-Vac GS Series - 1 Description; 2 Intended Use

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3M
™
Steri-Vac
™
Sterilizer /Aerator GSSeries – Operator’sManual
1. Description
The 3M™Steri-Vac™ Sterilizer/Aerators GS Series is for use in health care, industrial sterilization, research labs, veterinary surgical and other appropriate settings. 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. 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 GS 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.
Sterilizers have two preprogrammed sterilization cycles, 38°C and 55°C. Critical cycle parameters are detailed in Table1.
The GS Series sterilizer EO sterilization cycles consist of ten (10) 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 GS Series 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 GS Series EO SterilizationCycle
2. IntendedUse
The 3M™Steri-Vac™ Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices in the followingcycles:
Model Cycle Gas Expose Time (min.) Temperature (°C)
EO Concentration
(mg/L) Relative Humidity (%)
GS5
Cool
270 38 736 40-80
Warm 60 55 736 40-80
GS8
Cool 270 38 759 40-80
Warm 60 55 759 40-80
Table 1. GS Series Critical CycleParameters
Single or dual channel rigid and flexible scopes can be sterilized with non-lumened medical instruments in any of the GS sterilizer cycles provided the cycle parameters match the instrument’s
sterilization instructions. The load per cycle should not exceed 20lumens.
CAUTION: To reduce the risk of injury,
always follow the procedures described in this manual.