3M Steri-Vac GS Series Site Planning & Installation Manual Download Page 2

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Steri-Vac Sterilizer/Aerator GS Series

Site Planning and Installation Guide

70-2011-5643-0 Issue Date: 10/2015

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Table of Contents

I. Introduction

Device Safety Compliance

EMC Compliance

Plan and Install

II. Select the Equipment

III. Select the Location

Site Planning Worksheet

Proposed Location of Equipment

Pre-Installation Visit and Site Readiness Verification

IV. Preparing the Area and Service Requirements

Preparing the Selected Area

Utilities

Electrical Service Requirements

Compressed Air Requirements

Compressor System

Filters

Multiple Sterilizer/Aerator Installations

Compressed Air Line Installation Kit

Compressor Location

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Ethylene Oxide Vent Line Requirements

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Abator (Emission Control Devices)

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Vent Line Labeling and Install Considerations

Local Exhaust Hood Requirements

Exhaust Ventilation System Planning and Design

Exhaust Ventilation System Specifications

Ductwork

Exhaust Fan

Ventilation Failure Detector

First Aid: Exposure to Ethylene Oxide (EO)

Ethylene Oxide Storage

Requirements for a Vented Cabinet

Connect EO Storage Cabinet to GS Series Sterilizer Dedicated Exhaust

Disposal of 3M

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Steri-Gas

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EO Gas Cartridges

Outside Discharge

V. Final Installation and Support

Site Readiness Verification

Unpacking the GS Series Sterilizer

System Checkout and In-Service Training

VI: Install Guide for 3M

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In-Wall Mounting Unit

General Information

Finished Wall Specifications

Floor Preparation

Installing Permanent Floor Channels

Placement of 3M

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Steri-Vac

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Sterilizer/Aerators onto the Stacking Rack

Access Area

Installation of Stainless Steel Panels

General Specifications

Finished Installation

Stop and Hook Adjustment

Flexible Connections

Installing the Louvered Panel

Figure References for Section VI

Notes

ANNEX A Symbols, Safety Warnings and Cautions

Document Conventions

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Steri-Vac

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Sterilizer/Aerator GS Series – Explanation of Product and

Packaging Label and Symbols

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Steri-Gas

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EO Gas Cartridges –Explanation of Label and Symbols

Danger

First Aid

Dangers

Warnings

Cautions

ANNEX B Worksheets

Site Planning Worksheet

Equipment Location Worksheet

ANNEX C Site Readiness and Installation Verification Forms 48

Site Readiness Verification Form

Installation Verification Form

ANNEX D 3M

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Steri-Gas

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EO Gas Cartridge Dilution Charts

ANNEX E Bibliography and Compliance References

Equipment and Ethylene Oxide (EO) Compliance Documents

ANNEX F Disposal of Packaging

Contact Information

Summary of Contents for Steri-Vac GS Series

Page 1: ...Site Planning InstallationGuide 3M Steri Vac Sterilizer Aerator GS Series 3M...

Page 2: ...i Gas EO Gas Cartridges 27 Outside Discharge 27 V Final Installation and Support 28 Site Readiness Verification 28 Unpacking the GS Series Sterilizer 28 System Checkout and In Service Training 29 VI I...

Page 3: ...Steri Vac Sterilizer Aerator GS Series is an instrument and Class II medical device per the U S Food and Drug Administration FDA classification definitions It is a Class IIb medical device per the Eur...

Page 4: ...in which case the purchaser will be required to correct the interference at their own expense In addition operation of this device may accept any interference received including interference that may...

Page 5: ...page to document selected equipment Step 2 Select a Location Step 2 recommends a process for analyzing a site and for selecting a suitable location for installing the Sterilizer Aerator system This G...

Page 6: ...Door 136 L 4 8 cubic feet 38 43 83 cm 15 17 32 5in 70 9 76 2 95 0 cm 27 9 30 0 37 4in 3M Steri Vac Sterilizer Aerator GS5 Double Door EO Sterilizer Aerator 169 kg 373 lbs Double Door 132 kg 290 lbs Do...

Page 7: ...te Planning and Installation Guide 30 5 cm 12 in 76 2 cm 30 in 70 9 cm 27 9 in 47 6 cm 18 75 in 95 cm 37 4 in 50 2 cm 19 8 in 52 cm 20 5 in 26 6 cm 10 5 in 7 6 cm 7 6 cm 3 in 44 2 cm 17 4 in 3 in Figu...

Page 8: ...79 8 cm 70 8 in From Ground 31 8 cm 12 5 in 7 6 cm 3 in 88 9 cm 35 in 92 7 cm 36 5 in 109 2 cm 43 in 72 4 cm 28 5 in 54 6 cm 21 5 in 54 6 cm 21 5 in 3 2 cm 1 25 in Unload Side clearance two door betwe...

Page 9: ...cifications 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 GS Se...

Page 10: ...ommended room size is a minimum of 28 32 m3 1 000 ft3 has a non recirculating ventilation system The exhaust hood if used must be connected to an exhaust system that is dedicated to the 3M Steri Vac S...

Page 11: ...sheet ANNEX B to sketch the architectural details of the location where the equipment will be installed Include all details such as walls doorways structural supports ventilation ducts intake and exha...

Page 12: ...ch piece of equipment in the work area Figure 5 Include all other hard good items in the room e g work tables storage cabinets etc as this will help to assess the work flow After placing the 3M Steri...

Page 13: ...teri Vac Sterilizer Aerator GS Series Model GS5 can be installed in wall or installed and used with a 3M Stacking Rack Model 1237 as shown in Figure 6 The 3M Steri Vac Sterilizer Aerator GS Series Mod...

Page 14: ...re Installation Visit and Site Readiness Verification Prior to the installation of the 3M Steri Vac Sterilizer Aerator GS Series and any other accessory equipment the 3M Health Care service personnel...

Page 15: ...ectronic interfaces If required by national state or local regulations or facility company policy an ethylene oxide EO emission control system Utilities Consider the placement of utility services requ...

Page 16: ...he equipment and providing services to the equipment Requirement GS5 Sterilizer Aerator GS8 Sterilizer Aerator Voltage 200 240 Vac Frequency 50 60 Hz Phase Single Current 15 amp dedicated circuit Heat...

Page 17: ...ically have an automatic drain trap and be wired from the compressor controller Table 4 Compressed Air Specifications Specifications Value Range Pressure 7 0 kg cm2 100 psig minimum 10 5 kg cm2 150 ps...

Page 18: ...taminated air supply can quickly reduce the effectiveness of the filter element resulting in early equipment failure Multiple Sterilizer Aerator Installations Each 3M Steri Vac GS Series sterilizer re...

Page 19: ...rator models XL or XLS connected to a single EO Abator unit Sterilizer models 5XL and 8XL cannot be combined with a GS Series sterilizer when connecting to an EO Abator The EO Abator interfaces with G...

Page 20: ...r pedestrian traffic areas The inlet assembly from the Vent Line Installation Kit must be installed within 91 44 cm 3 ft of the sterilizer s EO port in a position that is accessible to 3M Health Care...

Page 21: ...and Installation Guide Roof Copper Line Maximum Length 91 5 m 300 ft Cupola Minimum radius two times the tubing diameter Insulation Steri Vac Sterilizer Aerator 5 cm 2 in 5 cm 2 in 30 5 cm 12 in 18 ga...

Page 22: ...st Hood Exhaust Ventilation System Planning and Design The following requirements must be met for planning and designing the ventilation system Determine the required air flow and the size length and...

Page 23: ...le duct can introduce significant air flow resistance Use a larger diameter flexible duct to minimize frictional air drag loss Minimize the number of elbows to reduce the static pressure loss in the s...

Page 24: ...i Vac Sterilizer Aerator GS Series Site Planning and Installation Guide Figure 14 Exhaust Connection Alternate Connection for Exhaust Hood Duct Exhaust Hood Duct Figure 15 Multiple Exhaust Hoods Vente...

Page 25: ...Gas Cartridges Check national state and local regulatory requirements including fire protection codes for storing EO To reduce the risks associated with fire and explosion 3M Steri Gas EO Gas Cartridg...

Page 26: ...hanges per hour inside the cabinet Connect EO Storage Cabinet to GS Series Sterilizer Dedicated Exhaust The vent for the storage cabinet can be connected into the overhead exhaust that is dedicated to...

Page 27: ...ispose of it in non incinerated waste or recycle per your facility s requirement See ANNEX E for additional information related to the proper handling of ethylene oxide EO Outside Discharge The ventil...

Page 28: ...plete the Site Readiness Verification Form ANNEX C and provide the form to the designated 3M Health Care service personnel or authorized 3M service personnel to review prior to the scheduled installat...

Page 29: ...ion the 3M Health Care service personnel or authorized 3M service personnel will complete the final Installation Verification Form and request signature by the purchaser s authorized personnel provide...

Page 30: ...ng Unit 1238 for installation remove the feet from the bottom of the Stacking Rack 1237 and install the supplied casters using 5 16 1 inch bolts nuts and washers Turn the Stacking Rack over so it is s...

Page 31: ...minimum 42 in The GS Series sterilizer must be available for fitting onto the unit at the time of installation since some adjustments may be necessary when attaching the front panels Installing Perma...

Page 32: ...the ADJUSTABLE NYLON FEET for this purpose Access Area Figure 28 is a generalized drawing of the service connections at the rear of the installation As previously described flexible lines are require...

Page 33: ...f the HOOK is to keep the unit from rolling forward as operators open and close Sterilizer Aerator doors Attach the HOOK on the bracket on the lower left comer of the STACKING RACK Attach the shoulder...

Page 34: ...teri Vac Sterilizer Aerator GS Series Site Planning and Installation Guide Figure References for Section VI Figure 18 Installation Print No 1 In Wall Mounting Unit 1238 Showing Stacking Rack Figure 19...

Page 35: ...1 ea Permanent Floor Channel Stop 1 ea 2 ea 5 16 1 Bolts 16 ea Louvered Panel 1 ea Hook Assembly 1 ea 1 4 Washer 8 ea 1 4 1 Bolt 8 ea Joining Tabs 2 ea Fastener 1 4 20 Stud 12 ea Side Channel L R 2 ea...

Page 36: ...nit Model 1238 Door Frame Opening Figure 22 Installation Print No 11 Model 1238 Pass Through 3M Steri Vac Sterilizer Aerator GS Series Model GS5 Installation Processed Goods Side Unprocessed Goods Sid...

Page 37: ...zer Aerator GS Series Site Planning and Installation Guide Figure 24 Installation Print No 10 3M In Wall Mounting Unit Model 1238 Stop and Hook Adjustment Stop Shoulder Hook Bolt Figure 25 Installatio...

Page 38: ...5643 0 Issue Date 10 2015 3M Steri Vac Sterilizer Aerator GS Series Site Planning and Installation Guide Figure 26 Installation Print No 6 3M In Wall Mounting Unit Model 1238 Mounting Extension Track...

Page 39: ...0 2011 5643 0 Issue Date 10 2015 3M Steri Vac Sterilizer Aerator GS Series Site Planning and Installation Guide Figure 27 Installation Print No 7 3M In Wall Mounting Unit Model 1238 Mounting Units to...

Page 40: ...urations Refer to the 3M Steri Vac Sterilizer Aerator GS Series and 3M Steri Vac XL Aerator Installation Guides for specific requirements Figure 28 Installation Print No 8 3M In Wall Mounting Unit Mod...

Page 41: ...70 2011 5643 0 Issue Date 10 2015 3M Steri Vac Sterilizer Aerator GS Series Site Planning and Installation Guide Figure 29 Installation Print No 9 Mounting Top Two 2 Panels Top Panel Bottom Panel 41...

Page 42: ...643 0 Issue Date 10 2015 3M Steri Vac Sterilizer Aerator GS Series Site Planning and Installation Guide Figure 30 Installation Print No 12 3M In Wall Mounting Unit Model 1238 Remove Extensions Mount B...

Page 43: ...43 3M Steri Vac Sterilizer Aerator GS Series Site Planning and Installation Guide 70 2011 5643 0 Issue Date 10 2015 Notes...

Page 44: ...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 accomp...

Page 45: ...ene 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...

Page 46: ...nd Installation Guide 70 2011 5643 0 Issue Date 10 2015 ANNEX B Worksheets Site Planning Worksheet Key Wall Supporting Column Doorway Intake Ventilation Duct Exhaust Ventilation Duct Electrical Recept...

Page 47: ...r GS Series Site Planning and Installation Guide 70 2011 5643 0 Issue Date 10 2015 Stacking Rack XL Aerator GS5 Sterilizer 1 1 1 2 2 2 GS8 Sterilizer Abator 1 Power Input and EO Vent 2 Local Exhaust S...

Page 48: ...n system Yes No 9 The vent line is a hard drawn copper tube Yes No 10 Enter the total linear length of the vent line from the GS Series sterilizer to the termination point on the outside of the buildi...

Page 49: ...nless steel braided flexible tubing used for the vent line 8c Is there a flexible line used on the air service so the GS Series sterilizer can be moved without disconnecting that service Yes No Yes No...

Page 50: ...100 231 37 Room volume ft3 600 17 100 170 5559 56 700 20 117 170 4765 55 800 23 133 170 4169 54 900 25 150 170 3706 53 1000 28 167 170 3335 53 1500 42 250 170 2224 50 2000 57 333 170 1668 49 2500 71...

Page 51: ...f industrial scientific and medical ISM radiofrequency equipment Australian Standard for EMC AS NZS 2064 EMC Directive 2004 104 EC Electromagnetic Compatibility Sterilizer Aerators for Medical Purpose...

Page 52: ...298 www 3m com infectionprevention 3M Canada Inc P O Box 5757 London Ontario Canada N6A4T1 1 800 563 2921 3M Deutschland GmbH Health Care Business Carl Schurz Str 1 41453 Neuss Germany 3M 3M Health Ca...

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