Introduction; Device Safety Compliance - 3M Steri-Vac GS Series Site Planning & Installation Manual

3M Steri-Vac Sterilizer/Aerator GS Series
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Site Planning and Installation Guide
I. Introduction
CAUTION
To reduce the risk of injury, always follow the
procedures described in this Site Planning and
Installation Guide.
This Site Planning and Installation Guide is intended to provide information for prospective and new
purchasers of the 3M Steri-Vac Sterilizer/Aerator GS Series, in order to help plan for and execute
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site and installation requirements.
The purchaser is responsible for providing required GS Series sterilizer service requirements to the
area where the equipment will be installed. These services include electricity, compressed air,
and an ethylene oxide (EO) vent line. A dedicated exhaust system is required for installing the
3M Steri-Vac Exhaust Hood option.
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The purchaser is responsible for installing the GS Series sterilizer and accessory equipment
in their permanent location and to connect the required services to the unit(s). The purchaser
is also responsible for ensuring that all national, state and local code requirements are met
(e.g., EO abatement, state of California seismic bracing, etc.). At the time of installation, 3M Health
Care service personnel or authorized 3M service personnel will require written documentation to
verify the requirements for room ventilation and non-recirculating ventilations systems are met.
See ANNEX A for a complete listing of symbols, safety warnings and cautions.

Device Safety Compliance

The 3M Steri-Vac Sterilizer/Aerator GS Series is an instrument and Class II medical device per the
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U.S. Food and Drug Administration (FDA) classification definitions. It is a Class IIb medical device per
the European Union Medical Device Directive (MDD) and carries a CE mark related to the Medical
Device Directive 93/42/EEC as confirmed in the Declaration of Conformity.
The 3M Steri-Vac Sterilizer/Aerator GS Series is listed as Laboratory Electrical Equipment for Use
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in Health Care Applications 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 is designed, manufactured, and tested to meet
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the safety and performance requirement of common safety codes and standards which include
applicable portions of the following standards demonstrated by the CB Scheme Certificate and
test report issued by Underwriters Laboratories (UL):
• IEC/EN 61010-1. Safety requirements for electrical equipment for measurement, control, and
laboratory use - Part 1: General requirements.
• IEC/EN 61010-2-010. 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. Safety requirements for electrical equipment for measurement, control,
and laboratory use - Part 2-040: Particular requirements for Sterilizer/Aerators and washer­
disinfectors used to treat medical devices.
• 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.
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70-2011-5643-0 Issue Date: 10/2015