F2066 Large Clinical Spec Sheet 2 20

Form 2066-2.20/030807 Page 1

PRIMUS Clinical – Large Size SterilizersThese sterilizers are designed for all Clinical applications including surgery, central sterile supply. They arepit-mounted, allowing the optional floor carts to roll directly into the chamber. PRIMUS sterilizers aredesigned, developed and manufactured in the USA according to Quality Management System which are incompliance with ISO 9001:2000, ISO 13485:2003, CMDCAS and FDA’s Good Manufacturing Practice forMedical Devices: General (GMP) regulation (21CFR Part 820). Large size sterilizers are one segment of 10standard clinical sizes manufactured by PRIMUS.

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The pressure vessel is the heart of any sterilizer.PRIMUS offers simple, straight forward, design. AllPRIMUS pressure vessels are constructed of solidstainless steel and are fabricated by PRIMUS in ourquality controlled, ASME facility. The interior chambersurface is polished to a mirror finish of <10µ in. Ra.The brilliant Pri-Mirror® reflective chamber finish setsthe highest standard for cleanliness and offers easyspill clean-up and resistance to staining anddegradation.

PRIMUS rectangular chambers eliminate the wastedspace and high utility cost common to old-stylecylindrical or elliptical chambers and jackets. Thisprovides savings in operating cost and service.

All large sizes of PRIMUS sterilizers havepneumatically powered horizontal operating doors,designed to be efficient, reliable and inherently safe.To close the door, depress and hold the doorbutton, if button is released door opens. An addedsafety feature, the doors stop automatically if anobstacle is encountered.

All PRIMUS steam sterilizers include Gravity,Vacuum and Liquid cycle settings. A Test/Vaccycle is provided for utilizing Bowie-Dick™ tests.

For surgical packs, select one of the vacuumcycles. For the sterilization of liquids in open orvented containers, select a liquids cycle.

The time-tested and reliable PRIMUS PSS500Microcomputer Control is an industrialmicroprocessor providing accuracy andautomation for all customer requirements. Thissimple, versatile, control has become the firstchoice for both sterilizer users and servicetechnicians.

STERILIZER DESIGN

STERILIZER CYCLES

Pit-mounted sterilizers with matching floorloading carts are guided into the chamber byfloor tracks which match cart casters. Pass-through models are available

PRIMUS Sterilizer Company, LLC • 117 South 25th Street • Omaha, NE 68131Phone (402) 344-4200 • Fax (402) 344-4242 • [email protected] • www.primus-sterilizer.com

Two 26” x 63” Pit Mounted Units

Form 2066-2.20/030807 Page 2

GENERAL (Options italicized) All models shall include Vacuum, Gravity andLiquids cycles. A Low Temperature Flowing Steamoption provides flowing steam at low temperaturesfor Research laboratories for specific applications.

VESSEL MATERIAL AND CONSTRUCTIONThe sterilizer will have a double-wall designproviding for a fully jacketed pressure vessel. Thechamber cross section will be rectangular with widthand height dimensions to include:

J - 26” x 63” x 48”K - 26” x 63” x 76”

The vessel material will be non-laminated solidstainless steel plate/sheet. The chamber, head-ringand door plate material will be 316L stainless steelwith an interior Pri-Mirror® finish of <10µ in. Ra.

DESIGN and MANUFACTURING APPROVALSThe vessel will be designed and constructed toASME code Section VIII Division I and pressurerated for 45 PSIG and full vacuum. ASME CodeStamp and U-1 form will bear the name of PRIMUSas the specified US manufacturer.

The sterilizer will be manufactured according toQuality Management Systems which are incompliance with ISO 9001:2000, ISO 13485:2003,CMDCAS, FDA and will be UL listed and inconformance to CSA requirements.

DOOR CONSTRUCTIONA pneumatically operated horizontally sliding doorwill be operable from the touchpad push button. Toclose door, depress/hold door button . If door buttonis released while closing, door reverses directionand opens. In the open position, the insulated doorwill be secured behind a panel preventing theoperator from contact with hot surfaces. An interlockwill prevent cycle start unless the door is fully closedand secured.

GENERAL CONSTRUCTIONThe vessel shall be insulated with 1" semi-rigid hightemperature fiberglass board/blanket overlaid withformed aluminum paneling and mounted in astructural steel frame. The frame shall be enamelcoated and fitted with adjustable legs on self-centering floor pads. The fascia and side panels willbe 16-gauge, type 304 stainless-steel, removable foreasy service access.

WATER CONSERVATIONTo conserve water and assure effluent exhausted todrain is 140oF or below, PRIMUS provides quenchwater on demand for exhaust effluent.

PURCHASING SPECIFICATION DATA SHEETEQUIPMENT WARRANTYSterilizer pressure vessels manufactured byPRIMUS are warranted against defects inworkmanship and materials under normal use andoperation for fifteen years where the sterilizer iscontinually maintained under PRIMUS servicecontract.

SERVICE and EQUIPMENT ACCESSStandard service access, when facing the unit will befrom left side and top. Wiring shall be laid side-by-side and mechanically secured flat against metalinsulations cover. All wiring will be clearly labeledand readily visible for visual tracing. Pipingcomponents will be threaded rigid brass and flaredcopper fittings, positioned with sufficient space forremoval and replacement without disassembly of theentire piping assembly. Wiring and pipingcomponents will be nonproprietary, industrial gradeavailable through Authorized Service Agencies, localsupply house, or direct from PRIMUS.

STEAM SOURCESteam will be from an in-house steam source in thequantity and quality specified. An optional electricboiler may be specified. Contact PRIMUS for specificboiler information

CONTROLSA PSS500 microcomputer will offer a selection of 8(eight) separate programs for the sterilization ofwrapped goods, hard-goods, liquids and test cycles.Cycle parameters may be set by the user and areadaptable to a wide range of products. Alarms areannunciated, displayed and printed. Cycle processparameters will be displayed and recordedthroughout the cycle. A side-mounted control paneland a thermal printer dot-matrix technology, and 32characters per line printing is provided. A secondcopy of the sterilization cycle report will be availableat the end of the run.

Standard Control Panel /Printer Arrangement

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Form 2066-2.20/030807 Page 3

DIMENSIONS, CUBAGE & WEIGHTS

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HVAC DATA Heat loss, at ambient of 700 F.

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Form 2066-2.20/030807 Page 4

VOLUME/DIMENSIONS CHART

1. Fascia extends 1” beyond wall opening on each side overlapping the wall and sealing the opening.2. Allow minimum 2” clearance at rear of recessed unit only. Cabinet side models have rear clearance built in.3. Contact PRIMUS for alternative wall opening.4. Standard left side service/equipment access show. Optional right side access is available.

PRIMUS Clinical - Large Sterilizers

Refer to General Arrangement drawings for details and final connection point to utility services. (S-Steam, W-Water, D-Drain, E-Electrical, A-Air)

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Form 2066-2.20/030807 Page 5

Refer to General Arrangement drawings for details and final connection point to utility services.(S-Steam, W-Water, D-Drain, E-Electrical, A-Air)

VOLUME/DIMENSIONS CHART


1. Fascia extends 1” beyond wall opening on each side overlapping the wall and sealing the opening.2. Contact PRIMUS for alternative wall opening.3. Standard left side service/equipment access show. Optional right side access is available.

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Form 2066-2.20/030807 Page 6


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Drawing is general example of PRIMUS’ pit installation. Refer to PRIMUS’ General Arrangement (GA)drawings for exact dimensions and pit installation details. Prior to installing your PRIMUS sterilizer verify thepit dimensions are correct with the PRIMUS GA Drawings, ensure the pit is square, clean and sealed.Contact PRIMUS for further pit installation information.

PIT DIMENSIONS CHART

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Form 2066-2.20/030807 Page 7

STERILIZER UTILITY SERVICESStub-in utility services within 6”-0” of final connection to sterilizer. Optimum performance requires the specified utilities.

ARCHITECTURAL NOTES:S

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ELECTRIC BOILERSLEDOM J K

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1. Allow sufficient space for traps, shut-off’s, filters and other utility supply components.2. Utility (service disconnects) shall be provided and installed “By Others”.3. Building or structure modifications to accommodate the sterilizer, as well as, sterilizer shoring, rigging,

cribbing and/or crane requirements into the facility performed “By Others”.4. Provide maximum mechanical and service access space (refer to page 4 and 5), additional space required

when boiler specified. See General Arrangement drawing, for placement of ancillary equipment and serviceaccess.

5. Some options affect utility services and overall dimensions.6. Water Quality - refer to page 67. The Manufacturer’s Equipment Warranty does not cover failure due to improper utility provisions.8. Drawings not to scale.9. Wall thickness must be provided on single and double door models recessed through 1 or 2 walls, with

cabinet sides.

1. Controls Current

Form 2066-2.20/030807 Page 8

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SELECT CONFIGURATION

Use the following pages to custom design your sterilizer by checking the boxes of the configurationand options required for your project. Transfer all items checked to the Specification Worksheet(Page 12) and fax to PRIMUS Sales Department or to your local Sales Representative for a quotation.If you do not find an option or size listed to meet your requirements, please contact our ProjectManager for additional information and assistance.

Model Number NotationSD = Single DoorDD = Double Door

PSS5-__-M__ __ __ J S = House Steam K E = Electric Boiler

Two models/sizes are offered:J - 26" x 63" x 48"K - 26" x 63" x 76"

A detailed formatted specification, suitable forinclusion in formal contract documents, isavailable on request.

Note: Use the above format to determine PRIMUS Model numberand insert below and on Page 12, Specification Worksheet.

PRIMUS Clinical Steam Pressure Sterilizer, Model Number PSS5___________.

SELECT CONFIGURATION

CabinetCD - Panels Both SidesCCL - Left Side PanelCCR - Right Side Panel

Steam SourceHouse SupplyElectric Boiler1, 2, 3, 5

EB1 - 208/3 phaseEB2 - 240/3 phaseEB3 - 480/3 phaseOther

EB04- Auto. Blowdown

DAR - Single Door (Right)DAL - Single Door (Left)DBR - Double Door (Right)DBL - Double Door (Left)

Door RecessedCA - One WallCB - Two Walls

Service and Equipment AccessLeft Side (Standard)Right Side

1. Electric boilers are available in Carbon Steel or Stainless Steel.2. Contact PRIMUS for overall dimensions and utility connections.3. All models are stand-alone4 Low Water Cutoff is standard and the “automatic reset” feature is disabled with this option. The boiler will need

to be manually reset.5. Water Quality - for best results, the feed water supply should be evaluated prior to initial start-up by a

reputable water conditioning company. If the mineral content exceeds recommended limits, various externaltreatment processes (water softener, water conditioning, etc.) may be used to correct the problem. ContactPRIMUS for further recommendations.

Form 2066-2.20/030807 Page 9

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CLINICAL LABORATORY CONFIGURATIONS

Low Temperature Flowing Steam P14For media preparation, formula and similar uses.Pasteurization is accomplished with flowing steam.In addition to standard sterilizer temperatureranges, this option allows cycles to operate in therange of 1680F (760C) to 2200F (1040C). Notintended for reprocessing reusable medicaldevices

PSS500 Control C6PSS500 microcomputer with eight (8) separatefactory preset cycles; seven (7) programmable and 1preset Test cycle are standard. A vertical touchpadcontains a Liquid Crystal Display (LCD) mounted on aside-mounted control panel with a thermal printer.Cycle progression is displayed by Light EmittingDiodes (LEDs) on the operator panel and printed, 32characters per line printing. A second copy of theentire sterilization cycle printable at the end of therun.

Cycles may be programmed by the end user but anydeviation from the factory preset values must bevalidated by the end-user.

CONTROLS AND RELATED OPTIONS(Contact PRIMUS for details and performance specifications)

1. Gravity cycles must be loaded in a manner to ensure no airis entrapped in the load. E.g., invert pans, beakers andsimilar items.

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Thermal Printer R7Thermal dot-matrix printer with take-up reel and 32character per line printing is standard. Secondsterilization cycle report available at the end of therun.

Remote Mount Control Panel C10Mount control panel in separate housing adjacent toor up to 35 feet away from the sterilizer.

Serial Data Output C11Supervisory use to capture electronic record of eachsterilization cycle. Cycle hard copy and display datais transmitted via RS232 in real time to remotecomputer, up to 100 feet away, for display andrecording. Hard copy records may be printed fromthe computer.

Contact PRIMUS for additional configurationoptions.

Form 2066-2.20/030807 Page 10

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UTILITY - RELATED OPTIONS(CON’T)

Uninterruptible Power Supply E2In the event of electrical power loss and no emergencyelectrical power to sterilizer, this option provides electri-cal power to operate control system for up to 30 min-utes, to complete the cycle. This option is a dedicatedpower source for the electronic controls only and will notsupport any power requirements for heavy power loadcomponents (boiler, pumps, compressors, etc.).

LOADING EQUIPMENT

Loading cart includes one bottom and one intermedi-ate shelf with four adjustable levels. Additionalshelves are available. Cart frames and shelves are316L stainless steel welded, ground and polished.Shelf surfaces are stainless steel wire mesh. Trans-fer carriages include swivel casters with swivel locksand 5” wheels with wheel brakes.

L4 Loading Cart (Floor Mounted Only) L5 Additional Cart Shelf L6 Transfer Carriage (Floor Mounted Only)

L7 Floor CartL8 Additional Floor Cart Shelves

NOTE: Loading cart and transfer carriages arerecommended for chamber lengths 48 inches orlonger. Pit Mounted units with chamber length equalor greater than 60” use one set of 2 floor carts

Contact PRIMUS for special loading equipmentrequirements.

FLOOR LOADER CART DIMENSIONS

GENERAL OPTIONS

Validation Port, 1.5 inch V4.1Provides chamber penetration to accommodatevarious monitoring/control probes. Two 1.5” valida-tion ports are standard. Option V5 provides for 2”validation ports.

Seismic Restraints V8Required in areas prone to seismic hazards.Secures sterilizer to building but allows for leveling.Designed to current California Code.

UTILITY - RELATED OPTIONS

Boost Pump for Low House Water Pressure P3Delivers required dynamic water pressure forefficient operation. Requires specified GPM flow.Contact PRIMUS for details and performancespecifications.

Transformers E1 Reduces line voltage to required 110 VAC foroperation of sterilizer controls.

E1A 220 vac to 110 vacE1B 480 vac to 110 vacE1C 480/240 to 240/120, 1 phase,

0.5 KVA

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Form 2066-2.20/030807 Page 11

This document and data contained within is intended for the exclusive use of PRIMUS customers, includingarchitects or designers. It shall not be reproduced in whole or in part without permission of PRIMUS SterilizerCompany. Any authorized reproduction must bear the entire page to include Headers and Footers.

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Three 26” x 63” Pit-mounted Units

QUALITY AND INTEGRITY FORM THE FOUNDATION OFPRIMUS STERILIZER COMPANY

OUR VISION FOR CONTINUAL IMPROVEMENT IS REALIZEDTHROUGH THE ESTABLISHMENT OF QUALITY OBJECTIVES

ACHIEVED THROUGH TEAMWORK WITH A GOAL OFRETURNING SIGNIFICANT VALUE TO OUR CUSTOMERS.

“PRIMUS Sterilizer... ...First In Quality Sterilization Products”


Form 2066-2.20/030807 Page 12

Complete the following by selecting or transferring those checked on preceding pages, required tomeet your needs. Tear off and forward completed worksheet to PRIMUS Sales Department,fax 402-344-4251, or your local PRIMUS Representative. If you do not find an option or size listed tomeet your requirement, please contact our Sales Department for additional information andassistance with a custom design to meet your specifications.

PRIMUS Specification Data Worksheet

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GENERAL CONFIGURATIONSDA Single DoorDB Double DoorCD Cabinet, 2 sidesCCL Cabinet, 1 Side LeftCCR Cabinet, 1 Side RightCA Recessed, 1 WallCB Recessed, 2 WallNPN Left Side Service (Std)C30 Right Side Service Access & ControlC31 Control Panel opposite side of ServicePM Pit Mounted (Std)FM Floor Mounted (Special Order with ramp

or carriage/cart)STEAM SOURCE

EB1 Boiler, 208/3phEB2 Boiler, 240/3phEB3 Boiler, 480/3phEBO Automatic boiler blow-downLWC Low Water Cutoff, Manual Reset (Std)

CLINICAL LABORATORY OPTIONS

P14 Low Temperature Flowing SteamCONTROLS & RELATED OPTIONS

C6 PSS500 Control (Std)C10 Remote Mounted Control PanelC11 Serial Data Output (RS 232)R7 Thermal Printer, 32 Column (Std)R1 Impact Printer, Flush Mount 24 ColumnR4 Thermal Printer, Take-up ReelR4.1 Thermal Printer, Flush Mount 24 Column

Manufacturer reserves the right to modify materials or specification without notice.

Std = Standard ComponentN/A = Not Available

FOR ADDITIONAL ASSISTANCETo discuss your sterilization design needs or to requesta Sterilizer Design Guide, please contact PRIMUS.

YOUR LOCAL PRIMUS REPRESENTATIVE:

GENERAL OPTIONSV4.1 Two Validation Ports, 1.5 “ diameter (Std)V5 Validation Port, 2.0” diameterV8 Seismic RestraintP10 Compressed Air to GasketP25 Drain Line Strainer/ValveEAC Air Compressor

UTILITY - RELATED OPTIONSP3 Boost Pump for Low House WaterE1A Transformer from 220V to 110VE1B Transformer from 480V to 110VE1C Transformer from 480/240 to 240/120V,

1 ph, 0.5KVAE2 UPS maintains control functionality for

30 minutes during power outageE3 GFI Receptacle

LOADING EQUIPMENTL4 Loading Cart (Floor Mount Only)L5 Additional Cart ShelvesL6 Transfer Carriage (Floor Mount Only)L7 Floor CartL8 Additional Shelves

VESSEL OPTIONC4 Jacket Pressure Display, Analog

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Documents

F2066 Large Clinical Spec Sheet 2 20