3M Steri-Vac GS Series - Air Supply Specifications; 8 Compliance and Reference Standards; Device Safety Compliance; Electromagnetic Compatibility (EMC) Compliance

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3M
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Steri-Vac
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Sterilizer /Aerator GS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/cm
2
(100psig) minimum to 10.5kg/cm
2
(150psig)maximum
Flow Rate 2.2liters per second at 7.0kg/cm
2
(4.7standard cubic feet per minute at 100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
The 3M™Steri-Vac™ Sterilizer/Aerator GS Series is an instrument, Class II medical device, per the U.S. Food and Drug Administration (FDA) classificationscheme.
The 3M™Steri-Vac™ Sterilizer/Aerator GS Series is a Class IIb medical device per the European Union Medical Device Directive (MDD 93/42/EEC) classificationscheme.
The 3M™Steri-Vac™ Sterilizer/Aerator GS 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, 2010, CSA 2nd Ed:2008, 2nd Ed:2013, 3rd Ed:2012) Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1:
Generalrequirements.
• IEC / EN 61010-2-010(2003, 3rd Ed:2014) 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, 2015) 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 3M™Steri-Vac™ Sterilizer/Aerator GS 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 GS 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 GS Series are certified as exempt from the scope of the ATEXDirective.
8.2. Electromagnetic Compatibility (EMC)Compliance
The 3M™Steri-Vac™ Sterilizer/Aerator GS 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 GS Series complies with the EMC requirements of the CE mark EMC Directive2004/108/EC.
The 3M™Steri-Vac™ Sterilizer/Aerator GS 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.