12
Form 2065-3.02/060612 Page 1 PRIMUS Healthcare– Medium Size Sterilizers These sterilizers are designed for all Healthcare applications including surgery, central sterile supply and clinical laboratories. PRIMUS sterilizers are designed and manufactured in the USA according to Quality Management Systems which are in compliance with ISO 9001:2008, ISO 13485:2003, CMDCAS and FDA’s Good Manufacturing Practice (GMP) for Medical Devices: General regulation (21CFR Part 820). Medium size sterilizers are one segment of 12 standard clinical sizes manufactured by PRIMUS. TECHNICAL DATA SHEET F Size - 26”x36”x48” Chamber button, if button is released door opens. An added safety feature, the doors stop automatically if an obstacle is encountered. STERILIZER CYCLES All PRIMUS Sterilizers include Gravity, Vacuum, and Liquid cycle settings. A Test/Vac cycle is provided for utilizing Bowie-Dick TM tests. For surgical packs, select one of the vacuum cycles. For the sterilization of liquids in open or vented containers, select a liquid cycle. The time-tested and reliable PRIMUS PSS500 Microcomputer control is an industrial microprocessor providing accuracy and automation for all for all customer requirements. This simple, versatile control has become the first choice for both sterilizer users and service technicians. STERILIZER DESIGN The pressure vessel is the heart of any sterilizer. PRIMUS offers simple straight forward design. All PRIMUS pressure vessels are constructed of solid stainless steel and are fabricated by PRIMUS in our quality controlled ASME facility. The interior chamber surface is polished to a mirror finish of <10μ in. Ra. The brilliant Pri-Mirror ® reflective chamber finish sets the highest standard for cleanliness and offers easy spill clean-up and resistance to staining and degradation. PRIMUS rectangular chambers eliminate the wasted space and high utility costs common to old-style cylindrical or elliptical chambers and jackets. This provides savings in operating cost and service. All medium sizes of PRIMUS sterilizers have pneumatically powered horizontal operating doors, designed to be efficient, reliable and inherently safe. To close the door, depress and hold the door PRIMUS Sterilizer Company, LLC • 6565 South 118 th Street • Omaha, NE 68137 Phone (402) 344-4200 Fax (402) 344-4242 info@primus-sterilizer .com www .primus-sterilizer .com

F2065.Medium Clinical Tech Data Sheet 3 02 · PRIMUS sterilizers are designed and manufactured in the USA according to Quality ... automation for all for all customer requirements

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Form 2065-3.02/060612 Page 1

PRIMUS Healthcare– Medium Size SterilizersThese sterilizers are designed for all Healthcare applications including surgery, central sterile supply andclinical laboratories. PRIMUS sterilizers are designed and manufactured in the USA according to QualityManagement Systems which are in compliance with ISO 9001:2008, ISO 13485:2003, CMDCAS and FDA’sGood Manufacturing Practice (GMP) for Medical Devices: General regulation (21CFR Part 820). Mediumsize sterilizers are one segment of 12 standard clinical sizes manufactured by PRIMUS.

TECHNICALDA

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EETF Size - 26”x36”x48” Chamber

button, if button is released door opens. Anadded safety feature, the doors stopautomatically if an obstacle is encountered.

STERILIZER CYCLESAll PRIMUS Sterilizers include Gravity, Vacuum,and Liquid cycle settings. A Test/Vac cycle isprovided for utilizing Bowie-DickTM tests.

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

The time-tested and reliable PRIMUS PSS500Microcomputer control is an industrialmicroprocessor providing accuracy andautomation for all for all customer requirements.This simple, versatile control has become thefirst choice for both sterilizer users and servicetechnicians.

STERILIZER DESIGNThe 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 inour quality controlled ASME facility. The interiorchamber surface is polished to a mirror finish of<10μ in. Ra. The brilliant Pri-Mirror® reflectivechamber finish sets the highest standard forcleanliness and offers easy spill clean-up andresistance to staining and degradation.

PRIMUS rectangular chambers eliminate thewasted space and high utility costs common toold-style cylindrical or elliptical chambers andjackets. This provides savings in operating costand service.

All medium sizes of PRIMUS sterilizers havepneumatically powered horizontal operating doors,designed to be efficient, reliable and inherentlysafe. To close the door, depress and hold the door

PRIMUS Sterilizer Company, LLC • 6565 South 118th Street • Omaha, NE 68137Phone (402) 344-4200 • Fax (402) 344-4242 • [email protected] • www.primus-sterilizer.com

Form 2065-3.02/060612 Page 2

PURCHASING SPECIFICATION DATA SHEET

GENERAL (Options italicized) All models will include Vacuum, Gravity and Liquidscycles. A Low Temperature Flowing Steam optionprovides flowing steam at low temperatures forClinical laboratories or similar applications.

VESSEL MATERIAL AND CONSTRUCTIONThe sterilizer will be a double-wall design providingfor a fully jacketed pressure vessel. The chambercross section will be rectangular with width andheight dimensions to include:

W x H x DE - 26” x 36” x 39”F - 26” x 36” x 48”G - 26” x 36” x 60”

G.1 - 32” x 36” x 48”

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 9001:2008, 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 door is closing, door reversesdirection and opens. In the open position, theinsulated door will be secured behind a panelpreventing the operator from contact with hotsurfaces. An interlock will prevent cycle start unlessthe door is fully closed and secured.

GENERAL CONSTRUCTIONThe vessel will be insulated with 1" semi-rigid hightemperature fiberglass board/blanket insulationoverlaid with formed aluminum paneling andmounted in a structural steel frame. The frame willbe enamel coated and fitted with adjustable legs onself-centering floor pads. The fascia and side panelswill be 16-gauge, type 304 stainless-steel material,removable for easy service access.

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

EQUIPMENT 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, willbe from left side and top. Wiring will be laid side-by-side and mechanically secured flat against metalinsulation cover. All wiring shall 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 ofthe entire piping assembly. Wiring and pipingcomponents will be non-proprietary, industrial grade,available through Authorized Service Agencies,local supply house, or direct from PRIMUS.

STEAM SOURCESteam will be from an in-house steam source in thequantity and quality specified. Optional electricsteam boiler may be specified. Contact PRIMUS foradditional 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 users 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, 32characters per line printing is provided. A copy of thesterilization cycle will be available at the end of therun.

Standard Control Panel /Printer Arrangement

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Form 2065-3.02/060612 Page 3

PRIMUS Healthcare - Medium SterilizersPRIMUS Healthcare - Medium SterilizersPRIMUS Healthcare - Medium SterilizersPRIMUS Healthcare - Medium SterilizersPRIMUS Healthcare - Medium Sterilizers

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 shown. Optional right side access is available.

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rebmahCotroolF 6.906/00.42 6.906/00.42 6.906/00.42 6.906/00.42

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

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TYPICAL ACCEPTED RANGES

Form 2065-3.02/060612 Page 4

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

PRIMUS Healthcare - Medium Sterilizers

VOLUME/DIMENSIONS CHART

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htgneLgninepOllaW 3 68.2921/09.05 64.1251/09.95 62.6281/09.17 8.4751/00.26

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rebmahCotroolF 6.906/00.42 6.906/00.42 6.906/00.42 6.906/00.42

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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 shown. Optional right side access is available.

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ancillary equipment area.

Form 2065-3.02/060612 Page 5

ARCHITECTURAL NOTES:

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

HVAC DATA Heat loss, at ambient of 700 F.

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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 3 and 4), additional space

required when boiler specified. See General Arrangement drawing, for placement of ancillaryequipment and service access.

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.

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Form 2065-3.02/060612 Page 6

SELECT CONFIGURATIONTEC

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EET Use the following pages to custom design your sterilizer by checking the boxes of the configuration

and options required for your project. Transfer all items checked to the Technical Worksheet (Page12) and fax to PRIMUS Sales Department or to your local Sales Representative for a quotation. If youdo not find an option or size listed to meet your requirements, please contact our Project Managerfor additional information and assistance.

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

PRIMUS Clinical Steam Pressure Sterilizer, Model Number PSS5___________.

Model Number NotationSD = Single DoorDD = Double Door

PSS5-__-M__ __ __ E S = House Steam F E = Electric BoilerGG.1

Three models/sizes are offered:E - 26" x 36" x 39"F - 26" x 36" x 48"G - 26" x 36" x 60"

G.1 - 32” x 36” x 48”

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

Cabinet CD - Panels Both Sides CCL - Left Side Panel CCR - Right Side Panel

Steam Source House Supply Electric Boiler1,2,3,5

EB1 - 208/3 phase EB2 - 240/3 phase EB3 - 480/3 phase Other

EB04,- Auto. Blowdown

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

Door Recessed CA - One Wall CB - Two Walls

Service and Equipment Access Left 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 alone.4 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 2065-3.02/060612 Page 7

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1. Gravity cycles must be loaded in a manner to ensureno air is entrapped in the load. E.g., invert pans,beakers and similar items.

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HEALTHCARE LABORATORY CONFIGURATIONS Low Temperature Flowing Steam P14

For 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 1Test cycle are standard. A vertical touchpad containsa Liquid Crystal Display (LCD) mounted on a side-mounted control panel with a thermal printer. Cycleprogression is displayed by Light Emitting Diodes(LEDs) on the operator panel and printed, 32 charac-ters per line printing. A second copy of the entiresterilization cycle printable at the end of the run.

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

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.

1 - Liquid Crystal Display (LCD)2 - Light Emmitting Diode (LED)3 - Cycle Buttons4 - Heart Buttons

1

2

4

3

* Cycles not available on the PSS5-G.1 model.

Form 2065-3.02/060612 Page 8

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 E1Reduces 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

Uninterruptible Power Supply E2In the event of electrical power loss and no emer-gency electrical power to sterilizer, this optionprovides electrical power to operate control systemfor up to 30 minutes, to complete the cycle. Thisoption is a dedicated power source for the electroniccontrols only and will not support any power require-ments for heavy power load components (boiler,pumps, compressors, etc.).

LOADING EQUIPMENT

Standard chamber shelving includes a fixed,removable, wire mesh bottom shelf, see notebelow. As an option an extendable bottom shelf,is available. Optional additional chambershelf(ves) may be specified.

Loading cart includes one bottom and oneintermediate shelf with four adjustable levels.Additional shelves are available. Cart frames andshelves are 316L stainless steel welded, groundand polished. Shelf surfaces are stainless steelwire mesh. Transfer carriages include swivelcasters with swivel locks and 5” wheels withwheel brakes.

L1 Removable Bottom ShelfL2 Extendable Bottom Shelf

( 26”x36”x39” Only)L3 Additional Chamber Shelf

(26”x36”x39” Only)L4 Loading CartL5 Additional Cart ShelfL6 Transfer Carriage

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Validation Port, 1.5” inch V4Provides chamber penetration to accommo-date various monitoring/control probes.Standard on all models.

Seismic Restraints V8Required in areas prone to seismic hazards.Secures sterilizer to building but allows forleveling. Designed to current CaliforniaCode.

NOTE: Loading cart and transfer carriages arerecommended for chamber lengths 48 inches orlonger.

Contact PRIMUS for special loading equipmentrequirements and/or for weight and load capacity.

Form 2065-3.02/060612 Page 9

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Transfer Carriage and Loading Cart Dimensions

Transfer Carriage and Loading Cart Dimensions Cont’d

PRIMUS Healthcare - Medium SterilizersPRIMUS Healthcare - Medium SterilizersPRIMUS Healthcare - Medium SterilizersPRIMUS Healthcare - Medium SterilizersPRIMUS Healthcare - Medium Sterilizers

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Form 2065-3.02/060612 Page 10

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relioB gk271/sbl083 gk771/sbl093 gk5.382/sbl526 gk482/sbl526

STERILIZER DIMENSIONS, CUBAGE & WEIGHTS

ELECTRIC BOILERLEDOM E F G 1.G

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93X63X626.099x4.419x4.066

84x63x622.9121x4.419x4.066

06x63x624251x4.419x4.066

84x63x239121x0061x4.066

eziSreiloB .rH/Wk 0.06 0.27 0.801 081

tuptuOmaetSrelioB rH/.sbl 0.181 0.712 0.523 0.523

largetnI ledoM A/N A/N A/N A/N

enolAdnatS ledoM E-BE F-BE G-BE 1.G-BE

hP3,802.C.A.V serepmA 761 002 003 003

hP3,042.C.A.V serepmA 541 471 062 062

hP3,084.C.A.V serepmA 37 78 031 031

.zH06,011.C.A.V 1 serepmA 01 01 01 01

1. Controls Current

1. Shipping dimensions are measured to the edge of the heat exchanger and include plumbing on,split beams removed, where applicable, front stainless steel panel and printer removed.

2. Knowckdown is vessel dimension only, dimension does not include plumbing, electrical or heatexchanger. Special Order Only, must be indicated when ordering.

Form 2065-3.02/060612 Page 11

26”x36”x48”DAL Door and optional Loading Cart with Transfer Carriage

“PRIMUS Sterilizer... ...Quality by Design, Excellence by Choice”

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, LLC. Any authorized reproduction must bear the entire page to include Headers and Footers.

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.

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PRIMUS Sterilizer Company, LLC • 6565 South 118th Street • Omaha, NE 68137Phone (402) 344-4200 • Fax (402) 344-4242 • [email protected] • www.primus-sterilizer.com

Form 2065-3.02/060612 Page 12

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

Complete the following by selecting or transferring the options, checked on preceding pages,required to meet your needs. Tear off and forward completed worksheet to PRIMUS SalesDepartment, fax 402-344-4242, or your local PRIMUS Representative. If you do not find an option orsize listed to meet your requirement, please contact our Sales Department for additional informationand assistance with a custom design to meet your specifications.

PRIMUS Healthcare Technical Data Worksheet

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 ServiceSTEAM SOURCEEB1 Boiler, 208/3phEB2 Boiler, 240/3phEB3 Boiler, 480/3phEBO Automatic boiler blow-downLWC Low Water Cutoff, Manual Reset (Std)

HEALTHCARE LABORATORY OPTIONS

P14 Low Temperature Flowing Steam

CONTROLS & RELATED OPTIONSC6 PSS500 Control (Std)C10 Remote Mount Control PanelC11 Serial Data Output (RS232)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

GENERAL OPTIONSV4 Validation Port, 1.5” diameterV8 Seismic RestraintP25 Drain Line Strainer/ValveEAC Air CompressorP10 Compressed Air to Gasket

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 EQUIPMENTL1 Removable Bottom Shelf (Std)L2 Extendable Bottom Shelf (26”x36”x39”

Only)L3 Additional Chamber Shelves

(26”x36”x39” Only)L4 Loading CartL5 Additional Cart ShelvesL6 Transfer Carriage

VESSEL OPTIONC4 Jacket Pressure Display, AnalogStd = Standard Component

N/A = Not Available

FOR ADDITIONAL ASSISTANCETo discuss your sterilization design needsor to request a Sterilizer Design Guide,please contact PRIMUS.

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YOUR LOCAL PRIMUS REPRESENTATIVE:

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PRIMUS Sterilizer Company, LLC • 6565 South 118th Street • Omaha, NE 68137Phone (402) 344-4200 • Fax (402) 344-4242 • [email protected] • www.primus-sterilizer.com