Sterilemax operation

SterilemaxTable Top Steam Sterilizer

Operation ManualSeries 1277

LT1277X1 • 5/23/07 Serial Number

Model Numbers VoltageST75925 120VST75920-33 220V

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Sterilemax Table Top Sterilizer

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Table of Contents

Introduction..........................................................................................................................................................5Safety Information ..............................................................................................................................................6Warnings ..........................................................................................................................................................6

Specifications ......................................................................................................................................................9Trays ................................................................................................................................................................9Dimensions ......................................................................................................................................................9Shipping Weight ..............................................................................................................................................9Electrical ..........................................................................................................................................................9Standards ........................................................................................................................................................9Reservoir Water ..............................................................................................................................................9Mounting ..........................................................................................................................................................9Controls............................................................................................................................................................9Environmental Conditions ..............................................................................................................................10Declaration of Conformity ..............................................................................................................................10

Description ........................................................................................................................................................11Operational Programs ....................................................................................................................................11Program Summary Chart ..............................................................................................................................12Controls..........................................................................................................................................................13Sterilizer Features..........................................................................................................................................14

Installation ........................................................................................................................................................16Location..........................................................................................................................................................16Unpacking ......................................................................................................................................................16Electrical Connections ..................................................................................................................................17Optional Printer ..............................................................................................................................................17Installation Instructions ..................................................................................................................................18

Altitude Adjustment............................................................................................................................................20Display Parameter Setup ..................................................................................................................................21Setting Month/Date/Year/Hour/Minute ..........................................................................................................21Changing Temperature Units ........................................................................................................................22Changing Pressure Units ..............................................................................................................................22Changing Printer Mode ..................................................................................................................................23

Sterilization Procedures ....................................................................................................................................24Materials Appropriate For Steam Sterilization ..............................................................................................24Instrument Cleaning Prior To Sterilization......................................................................................................25Preparation of Carbon Steel Instruments ......................................................................................................26Preparing Items for Sterilization ....................................................................................................................26Loading the Sterilizer Chamber ....................................................................................................................31Handling Sterilized Materials ........................................................................................................................32

Recommended Monitoring ................................................................................................................................33Process Monitoring ........................................................................................................................................33Biological Indicators ......................................................................................................................................34

Operation ..........................................................................................................................................................36Initial Startup ..................................................................................................................................................36Outline of Operation ......................................................................................................................................37Details of Operation ......................................................................................................................................37Drying Sterilized Loads ..................................................................................................................................38

Optional Printer ................................................................................................................................................39Connecting and Starting the Printer ..............................................................................................................39

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Control Panel ................................................................................................................................................39Installing the Paper Roll ................................................................................................................................40Printer Operation............................................................................................................................................40Printer Tape Description ................................................................................................................................41Printer Record Storage ..................................................................................................................................42

Special Operating Instructions ..........................................................................................................................44Emergency Off (Cycle Abort) ........................................................................................................................44Resetting Automatic OTP ..............................................................................................................................44Erratic Controls Display or Operation ............................................................................................................45Power Failure During Sterilizing Cycle ..........................................................................................................45Problem Solving Chart ..................................................................................................................................46Maintenance Schedule Chart ........................................................................................................................48Maintenance ..................................................................................................................................................49Daily Maintenance ........................................................................................................................................49Weekly Maintenance......................................................................................................................................49Monthly Maintenance ....................................................................................................................................50Emptying Collection Bottle ............................................................................................................................51Cleaning Non-Recirculating Water Cooling Tank ..........................................................................................52Changing Door Gasket ..................................................................................................................................53Figures ..........................................................................................................................................................54Parts List ........................................................................................................................................................57Ordering Procedures......................................................................................................................................59

Decontamination Statement ..............................................................................................................................59One Year Limited Warranty ..............................................................................................................................60

TABLE OF CONTENTS

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Introduction

This Thermo Scientific Sterilemax Table Top steam sterilizerhas been designed for use in medical and dental offices, uni-versity laboratories, clinics, hospitals and other locationswhere a variety of materials require sterilizing.

Your sterilizer can be used for wrapped or unwrappedinstruments, packs, liquids, test tubes, petri dishes andmedia.

The optional Impact printer provides a permanentrecord of actual exposure times and temperatures.

General UsageDo not use this equipment for any purpose other than itsintended use, described in this manual.

WarningDo not use this equipment forany purpose other than itsintended use, described in thismanual.

Do not use the sterilizer toprocess volatile substances ormaterials which could releasetoxic or explosive substances.

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Safety Information

Warnings1. Do not use this equipment for any purpose other than

its intended use, described in this manual.

2. Use only self-venting, automatic sealing stopperswhen processing liquids or media. Use of other stop-pers or seals, or lack of stoppers, will create the pos-sibility of burns or injury from boiling liquids andexploding flasks.

3. Refer servicing to qualified personnel.

4. Use caution when opening the sterilizer door. Standto the side behind the door and open door slowly andpartially to protect yourself from escaping steam orboiling liquids and exploding flasks.

5. Sterilizer and trays will be hot after cycle is run.Always wear protective gloves and apron whenremoving a processed load. Protective gloves andapron should also be worn when reloading sterilizerfollowing previous operation.

6. Do not attempt to open sterilizer door until the displayreads "Cycle Complete". Pressure within the cham-ber could cause the door to open with extreme force,possibly causing personal injury.

7. Ensure that the sterilizer is cool before cleaning toavoid burns.

8. Pressurized steam will be discharged when the reliefvalve is opened. To prevent burns, place a steambarrier (such as a rolled towel) around the opening inthe back of the unit. To prevent burns, wear gloves oruse an extension device if it becomes necessary tooperate the pull ring.

WarningWarnings alert you to a possibility ofpersonal injury.

CautionCautions alert you to a possibilityof damage to the equipment.

NoteNotes alert you to pertinent factsand conditions.

Hot SurfaceHot surfaces alert you to a possibilityof personal injury if you come incontact with a surface during use orfor a period of time after use.

Alert Signals

Consult Instructions for UseThis symbol appears on the productto refer you to the instruction manualfor further information.

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9. Do not use the sterilizer to process volatile sub-stances or materials which could release toxic orexplosive substances.

10. Connect only to an electrical circuit of the appropri-ate voltage and load rating.

11. Do not overfill reservoir. To avoid slippery condi-tions and possible load recontamination, immedi-ately wipe up all spillage resulting from overfillingchamber or reservoir.

12. Do not add water to reservoir while a sterilizationcycle is in process. When the cycle ends andsteam vents back into the reservoir, a suddenoverflow of hot water could occur, possibly result-ing in burns to personnel.

13. To prevent collection of mineral deposits and corro-sion of chamber components, use distilled or lowquality deionized water only. Clean chamber aftereach use if sterilizing saline solutions.

14. Processing goods at less than recommendedtime/temperature could result in unsterile goods.

15. Reprocess your load when the sterilizing cycle hasbeen terminated prematurely. The load may not besterile when the sterilizing cycle has been terminat-ed prematurely.

16. Open door slowly at the end of a liquid sterilizationcycle. Do not allow hot bottles to be jolted. Thiscan cause bottle explosions. Do not move bottles ifany boiling or bubbling is present.

17. Allow bottles to cool before attempting to movethem from sterilizer shelf or tray(s) to the storagearea.

18. If media is processed, bottles and tubes shouldcontain no more than 3/4 the total volume of thecontainer. When processing water bottles and test

SAFETY INFORMATION

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tubes, the bottles and tubes should contain nomore than 3/4 the total volume of the container.Chamber should be cleaned daily when process-ing media.

19. Keep patients at least six (6) feet away from thesterilizer when it is in use.

20. Do not operate this sterilizer in the presence offlammable or explosive substances (such as anes-thetics). A fire or explosion could occur.

21. Never use a wire brush, steel wool, abrasive mate-rial, or chloride-containing products to clean doorand chamber assembly.

22. Use a process monitor in every cycle to ensureexposure to minimum sterilizing conditions. Use abiological indicator once a week to verify your ster-ilization process.

23. Dental handpieces should be run only on optionalcycle at 132°C for 10 minutes. Check manufactur-er's recommendations for sterilization parameters.

SAFETY INFORMATION

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Specifications

Trays

Tray DimensionsLarge - 15 1/2" x 9 3/16"

(39.4 x 23.3 cm)Small - 15 1/2" x 6"

(39.4 x 15.2 cm)

Number of TraysThe sterilizer is supplied with twotrays, 1 large and 1 small, and onerack.

Dimensions

Capacity34 Liters (Vessel) (1.2 cubic feet)7.0 Liters (Reservoir)

Overall DimensionsW x D x H Inches(cm)22 7/16" x 24 1/2" x 17"(57.0 x 62.2 x 43.2)Chamber (Dia. x Depth)12" X 18"(30.5 x 45.7)

Shipping Weight85 lbs. (38.5 kg)

Electrical

Heater Power1500 W

Power requirements120V, 50/60 Hz, 12.5 Amps220V, 50/60 Hz, 6.5 Amps

StandardsASMEUL/cUL to UL3101-1

Reservoir WaterDistilled or low qualitydeionizedMax. 1.5 Megohm/cmMin. .5 Megohm/cm

MountingBenchtop only

ControlsFixed Cycles

- Liquid- Packs- Wrapped- Unwrapped

Optional Cycle

NoteYou can examinethe pressure vesselrating plate for thesterilizer chamber byopening the panelon the back cover ofthe sterilizer, thenremoving the smallplug of insulation onthe back of the ster-ilizer chamber.

Environmental ConditionsOperating: 4°C - 40°C; 20% - 80% relative humidity, noncondensing. Installation Category II(overvoltage) in accordance with IEC 664. Pollution Degree 2 in accordance with IEC 664.Altitude limit: 3,650 meters.Storage: -25°C - 65°C; 20% - 80% relative humidity.

Declaration of Conformity(for 230 volt, CE models only)We hereby declare under our sole responsibility that this product conforms with the technical requirements ofthe following standards:

EMC: EN 61000-3-2 Limits for harmonic current emissionsEN 61000-3-3 Limits for voltage fluctuations and flickerEN 61326-1 Electrical equipment for measurement,

control, and laboratory use; Part I: GeneralRequirements.

Safety: EN 61010-1 Safety requirements for electrical equipmentfor measurement, control, and laboratoryuse; Part I: General Requirements.

EN/EIC 61610-2-010 Part II: Particular requirements forlaboratory equipment for the heating of materials.

EN61010-2-041 Part II: Particular requirements for autoclaves using steamfor the treatment of medical materials, and for laboratoryprocesses.

and meets the requirements of the Medical Device Directive 93/42/EEC, and its relevant transition into thenational laws of the member states into which we place the device(s).

The authorized representative located within the European Community is:Thermo Fisher Scientific419 Sutton RoadSouthend On SeaEssex SS2 5PHUnited Kingdom

Copies of the Declaration of Conformity are available upon request

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SPECIFICATIONS

0086

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NoteThe liquid cycle is not designed forsterilization of liquids in a clinicalapplication. Do not prepare sterileliquids for in vivo applications withthe Sterilemax system.

Dental handpieces should be runin the optional cycle at 132°C for10 minutes. Refer to manufactur-er's recommendations for contraindication of sterilization parame-ters.

When sterilizing handpieces, referto the manufacturer's specifica-tions on handpieces for contraindication of sterilization parame-ters.

Operational ProgramsThe sterilizer has four preset cycles which have been opti-mized to provide excellent results for most applications. Inaddition, there is one optional cycle that allows you to setyour own sterilization parameters. You access the pre-pro-grammed cycles by pushing one of the four green fixed-cyclebuttons. The four preset sterilization programs are:

Unwrapped GoodsFor unwrapped instruments and items made of metal,

glass or plastic. Parameters: 3 minutes at 135°C.

Wrapped GoodsFor wrapped packs of clothes, bandages, pads, fabrics,

rubber tubing and metal instruments. Parameters: 10 minutesat 135°C.

LiquidsFor distilled water, media solutions and other liquid pre-

pared in closed bottles or flasks. Parameters: 15 minutes at121°C.

PacksFor packs of instruments and towels and other packed

goods. Parameters: 30 minutes at 121°C.

Description

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Program Summary Chart

DESCRIPTION

NoteWhen sterilizing handpieces, refer to the manufacturer'sspecifications on handpieces for contra indication ofsterilization parameters.

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DESCRIPTION

NoteThe "Select" button is used by ser-vice personnel to adjust the oper-ating parameters of the sterilizer.

ControlsAll cycles and programming are selected and set in using thefront touchpad selector buttons.

Power SwitchThe Power Switch turns power to the unit on and off. Whenyou turn the power on, the display will be set to select a steril-ization cycle. It is located under the right front corner of thesterilizer.

Cycle Buttons (Green)These buttons allow you to run the preprogrammed cycles atthe touch of a button. See Operational Programs.

Optional Cycle (Yellow)This parameter allows you to select different time and tem-perature levels for your cycles than those provided with ourpreset programs. An optional cycle can be run as either a liq-uid or hard goods cycle. All material run in this cycle must bevalidated by the user.

Up/Down Arrows (Yellow)These allow you to set the time and temperature in an option-al cycle. They are also used for scrolling through other func-tions.

Start Cycle (Dark Green)Pressing the "Start Cycle" Switch activates the currentlyselected processing cycle. It is also used for scrolling throughother functions.

Stop (Red)This control is used to terminate any cycle. It is also used forscrolling through other functions.

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DESCRIPTION

Sterilizer Features

Optional PrinterThe optional printer available is an impact printer that recordseach cycle's performance. See page 39 for more information.

Pressure MonitorThe pressure monitor indicates the pressure inside the chamber.This monitor's readings can be found on the display as eachcycle is running.

Door SecurityWhile the chamber is under pressure, the door is held securelyclosed with three separate locking systems. First, there is a lock-ing handle that you must tighten to hold the door fully closed. Thelocking handle turns clockwise to close and counterclockwise toopen. Second, there is a pressure actuated locking pin whichautomatically secures the door, preventing it from being inadver-tently opened while there is pressure in the chamber. Finally,there is a backup catch which will prevent the door from openingfully even if there is a small amount of pressure in the chamber.You release this catch with a lever which is located in the lowerleft side of the door. To fully open the door, pull the door releaselever toward you.

Optional Non-Recirculating TankThe optional non-recirculating tank is used to collect the remain-ing cycle water after a cycle has completed. This prevents anydebris from the cycle to go back into the fresh water reservoir.

Door SwitchActuated by the door, the door switch prevents operation of thesterilizer if the door is not fully closed.

Pressure Relief ValveThis valve protects the coded vessel from pressures exceedingthe pressure rating of the vessel. The valve opens and releasessteam in the event that pressure in the vessel exceeds 45 PSIG(310 kPa). The pressure line is located in the back of the unit. An

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WarningPressurized steam will bedischarged when the reliefvalve is opened. To preventburns, wear gloves or usean extension device if itbecomes necessary to oper-ate the pull ring.

access hole is located in the back panel to allow you to peri-odically check relief valve operation.

Reservoir DrainA drain assembly is provided to empty the reservoir. Thereservoir drain assembly and plug are located at the lowerright of the chamber opening on the front of the sterilizer (asyou face the unit). The drain assembly attaches to the drainconnector so a hose can be attached for draining the steriliz-er reservoir into a container.

Trays and Tray RackA rack for the inside of the sterilizer is provided to hold theinstrument trays. The rack slides out of the chamber to allowperiodic cleaning of the chamber and rack.Three large trays and one small tray can be placed into the

rack or the rack can be used with only one or two trays or notrays. Tall items can be sterilized by removing both trays andplacing the objects on the bottom surface of the rack. Onelarge and one small tray are provided with the unit. See"Loading the Sterilizer Chamber" on page 31 of this manual.

DESCRIPTION

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Installation

LocationFor optimum performance of your sterilizer, the sterilizershould be installed in conformance to the following parame-ters:

SurfaceFor proper operation, the sterilizer must be placed on a level,heat and water resistant surface. If the surface is not level,the water in the sterilizer will be unevenly distributed, possiblyresulting in a sterilizer malfunction. Do not adjust position ofthe feet on the sterilizer.

ClearancesAllow at least 3" (75mm) between the sterilizer and walls onthe sides and back for air circulation. Also allow at least 8"(204mm) between the top of the sterilizer and any overhang-ing cabinet above it. Overhangs should not project more than8" (204mm) over the rear of the sterilizer.

SurroundingsIf the sterilizer will be operated continuously, locate it in anarea where its steam emissions will not damage equipment ormaterials.

UnpackingRemove the sterilizer carefully and inspect it for any shippingdamage. Do not throw away packing materials until youinspect the unit.1. Turn the door handle counterclockwise until it is

completely loose and move the locking mechanismto the left. Pull on the latch release lever built intothe left side of the sterilizer door and carefullyopen the sterilizer door.

2. Remove all packing materials and accessoriesfrom the chamber.

3. Remove the trays and rack assembly from thechamber.

CautionThe surface beneath the sterilizercould reach 100°F (38°C).

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4. Check for any foreign material in the chamber.Wipe clean with a damp, lint-free cloth if neces-sary.

Electrical ConnectionsWe recommend that you use a separate (dedicated) circuitfor this sterilizer. Ensure that the circuit is rated for the load.(See Electrical Specifications.)1. Connect power cord to power entry module on

back of unit.

2. Plug power cord into a grounded outlet of theappropriate voltage and load rating.

Optional PrinterSee section "Optional Printer" for installation, startup andoperation.

INSTALLATION

WarningConnect only to an electrical cir-cuit of the appropriate voltage andload rating.

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Installation Instructions1. To connect the non-recirculating water accessory

to the back of the sterilizer.

a. Unplug the sterilizer power cord. Allow the unit tocool to room temperature.

b. Move the sterilizer to gain access to the rear ofthe unit.

c. Unscrew the cap from the nonrecirculating dis-charge port of the sterilizer (located on the rear ofthe sterilizer).

d. Attach the discharge hose from the non-recircu-lating discharge port.

e. Tighten the nut finger tight plus a quarter turn witha wrench.

f. Attach the other end of the discharge hose to thefitting on the lower left (rear) of the non-recirculat-ing cooling tank. Follow the same procedure assteps d and e above.

CautionBe sure connectionnut is started straight.Cross threading willcause leaks and dam-age the nut and fitting.

Improper Discharge Hose ConnectionDischarge Hose Connection

Optional Non-Recirculating Tank

Cap

Removing Cap

Tighten nut fin-ger tight plus 1/4turn withwrench. After discharge

hose assemblyfrom cooling tank tonon-recirculatingdischarge port.

1/4 turn

NOTE: If you did not purchase an optional non-recirculationtank, please proceed to Altitude Adjustment

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2. Install the cap removed in step c. To the fittinglocated in the reservoir. See Cap Replacement

3. Fill the cooling tank with distilled or deionizedwater until the water begins to overflow from thecooling tank into the collection bottle (or into thedrain if the overflow tube is installed).

4. Plug in the power cord.

WarningNon-recirculating option must be installedbefore proceeding.

Filling Cooling Tank

CautionThe non-recirculating tank (cooling tank)must be connected to the sterilizer beforefilling with distilled or deionized water.

CautionDo not operate sterilizer unless the non-recirculatingtank is filled with distilled or deionized water andattached to the sterilizer.

Full mark

Collection Bottle

Fill with distilled ordeionized water untilit overflows into thecollection bottle(approx. 3 gal.)

OptionalOverflow Drain

Remove Cap

Cap Replacement

OPTIONAL NON-RECIRCULATING TANK

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Altitude Adjustment

For proper operation, the sterilizer program accounts for thealtitude in controlling certain functions. The sterilizer isshipped with a factory-set altitude value suitable for all alti-tudes up to an altitude of 1000 feet above sea level. If youraltitude is above 1000 feet above sea level, you will need toenter a new value for the altitude adjustment. To change thealtitude adjustment value:1. At the "Select Cycle" screen, press the "Select"

key and then the up arrow key. The sterilizer willdisplay a "Configuration Info" screen, then it willautomatically change to displaying the "ChangeTime" screen.

2. At the "Change Time" screen, press the "Select"key and then the "Liquids" key.

3. At the "Altitude Adjustment" screen, press the uparrow to select "Yes".

4. At the "Current Altitude" screen, press the up anddown arrows to set the value for your location'saltitude to the nearest one hundred feet.

5. After you have set your altitude value, press the"Start" key to return to the "Select Cycle" screen.

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Setting Month/Date/Year/Hour/MinuteTo set the current date and time:1. From the "Select Cycle" screen, press the "Select"

key and then the up arrow key.

2. Wait for the sterilizer to display the "Change Time"Screen. Press the up arrow key to select "Yes."

3. At the "Set Current Month" screen, press the up ordown arrow key to set the current month. Pressthe "Start" key when the current month is set.

4. At the "Set Current Date" screen, press the up ordown arrow key to set the current date. Press the"Start" key when the current date is set.

5. At the "Set Current Year" screen, press the up ordown arrow key to set the current year's final twodigits. Press the "Start" key when the current yearis set.

6. At the "Change Hour" screen, press the up ordown arrow key to set the current twenty-four hourclock hour. Press the "Start" key when the currenthour is set.

7. At the "Change Minute" screen, press the up ordown arrow key to set the current minute. Pressthe "Start" key when the current minute is set.

8. At the "Change Temperature Units" screen, pressthe down arrow key to select "No."

9. At the "Change Pressure Units" screen, press thedown arrow key to select "No".

10. At the "Change Printer Mode" screen, pressDOWN ARROW key to select "NO" and return tothe "Select Cycle" screen.

Display Parameter Setup

NoteSterilemax sterilizers are shippedwith the display units set as fol-lows:

120 volt units - °C, PSI

220 volt units - °C, BAR

If your unit is not set to these fac-tory settings or if you require othersettings, refer to "ChangingTemperature Units" and "ChangingPressure Units" to set the units toyour requirements.

NoteIf you desire to change the tem-perature units, press the up arrowto select "Yes", then refer to"Changing Temperature Units."

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Changing Temperature UnitsTo change the units in which the chamber temperature is dis-played on the digital display and printer tape (°C or °F):1. From the "Select Cycle" screen, press the "Select" key

and then the up arrow key.

2. Wait for the sterilizer to display the "Change Time"Screen. Press the down arrow key to select "No."

3. The sterilizer will then display the "ChangeTemperature" screen. Press the up arrow key to select"Yes."

4. At the "Temperature Units" screen, press the up arrowkey to toggle between °C and °F.

5. After you have selected your desired temperatureunits, press the "Start" key.

6. At the "Change Pressure Units" screen, press theDOWN ARROW KEY to select "NO".

7. At the "Change Printer Mode" screen, press theDOWN ARROW KEY to select "NO" and return to the"Select Cycle" screen.

Changing Pressure UnitsTo change the units in which the chamber pressure is displayedon the digital display and the printer tape (PSI, BAR or KPA):1. From the "Select Cycle" screen, press the "Select" key

and then the up arrow key.

2. Wait for the sterilizer to display the "Change Time"Screen. Press the down arrow key to select "No."

3. The sterilizer will then display the "ChangeTemperature" screen. Press the down arrow key toselect "No."

DISPLAY PARAMETER SETUP

NoteIf you desire to change the pres-sure units, press the up arrow toselect "Yes", then refer to"Changing Pressure Units."

NoteIf you desire to change the pres-sure units, press the up arrow toselect "Yes", then refer to"Changing Pressure Units."

NoteIf you desire to change the pressureunits press the UP ARROW to select"YES", then refer to "Change PrinterMode."

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4. At the "Change Pressure Units" screen, press theup arrow key to select "Yes."

5. At the "Pressure Units" screen, press the up arrowto cycle between the three available units.

6. When you have selected your desired pressureunits, press the "Start" key to enter units.

7. At the "Change Printer Mode" screen, press theDOWN ARROW key to select "NO" and return tothe "Select Cycle" screen.

Changing Printer ModesThis display is used to change the mode serial port of use foroptional printers from USED/UNUSED:1. From the "Select Cycle" screen, press the "Select"

key and then the UP ARROW key.

2. Wait for the "Change Time" screen. Press theDOWN ARROW key to select "NO."

3. The sterilizer will then display the "ChangeTemperature" screen. Press the DOWN ARROWkey to select "NO."

4. At the "Change Pressure Units" screen, press theDOWN ARROW key to select "NO."

5. At the "Change Printer Mode" screen, press theUP ARROW to select "YES."

6. At the "Printer Mode" screen, press the UPARROW to toggle between the available modes.

7. When you have selected your desired mode ofoperation, press the "Start" key to return to the"Select Cycle" screen.

DISPLAY PARAMETER SETUP

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Sterilization Procedures

Materials Appropriate For SteamSterilization

• Straight stainless steel instruments

• Surgical stainless steel hingedinstruments

• Pouches of instruments

• Carbon steel instruments (see specialpreparation instructions)

• Air powered instruments made to beautoclaved

• Needles

• Syringes

• Treatment trays

• Heat resistant plastic items

• Rubber gloves

• Heat resistant rubber tubing

• Heat resistant rubber sheeting

• Glass slabs and beakers

• Gauze

• Sutures

• Linen packs

• Liquids, non-clinical

• Other heat-resistant, immersible items

Always check with the manufacturer of your supplies forspecific instructions for sterilization.

WarningDo not attempt to sterilize volatileor toxic substances. Serious injuryor death could result.

CautionDo not attempt to sterilize anyobject composed of materialswhich cannot withstand high tem-peratures (135°C or greater).

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Instrument Cleaning Prior ToSterilizationTransport soiled instruments to your cleanup area on a tray.Sort out any instruments unsuitable for sterilization (see liston page 24).

Follow manufacturer's recommendations for cleaningand preparing any particular item.In the absence of manufacturer's specific instructions, cleaninstruments as follows:1. Rinse instruments thoroughly with a hard stream of

water to remove debris.

2. Sort instruments by their metallic composition. Donot mix instruments of different metals, as instru-ment damage will result.

3. Using either a fresh solution of detergent and dis-tilled water or a germicide solution, wash instru-ments in an ultrasonic cleaner for five to ten min-utes. Clean all instruments in an open position.

Use a detergent or germicide with a neutral pH (7)specifically designed for use in an ultrasonic clean-er.

Use new ultrasonic cleaning solution each day.

4. After cleaning, rinse instruments thoroughly in dis-tilled or deionized water. Inspect to ensure that alldebris has been removed. Repeat cleaning asnecessary.

If distilled or deionized water is unavailable andinstruments are rinsed in tap water instead, allinstruments should be dried before sterilizing toprevent staining.

5. Refer to manufacturer's recommendations for lubri-cating instruments after ultrasonic cleaning. Use asilicon lubricant which will not interfere with steril-ization.

STERILIZATION PROCEDURES

WarningThoroughly clean instrumentsbefore placing them in the steriliz-er. Sterilizing items contaminatedwith blood or debris will impedesterilization and may result inunsterile instruments, which maycause personal injury or death.

WarningAlways wear protective gloveswhen handling soiled instrumentsto protect yourself from the possi-bility of serious infection. Cleangloved hands with a germicidalcleaner when finished handlingsoiled instruments.

CautionSterilizing items contaminated withblood or debris may cause stainingor damage to the instruments orthe sterilizer.

CautionUse of soaking solutions contain-ing phenols or quaternary ammo-nium compounds may cause cor-rosion of the instruments, traysand the stainless steel chamber.

26

WarningDo not overload the trays.Overloading trays may result ininadequate sterilization andunsterile instruments.

WarningMonitor the sterilization process withprocess monitors and biological indi-cators as described inRecommended Monitoring (p. 33).

Preparation of Carbon SteelInstrumentsCarbon steel instruments must be carefully prepared prior tosterilization to prevent rusting. After cleaning according to themanufacturer's recommendations or the methods presentedin Instrument Cleaning Prior To Sterilization, prepare car-bon steel instruments as follows:1. Prepare a 2% solution of sodium nitrate in water

(approximately one table spoon in a quart ofwater). Completely immerse the instruments in thesolution and allow them to soak for three minutes.

2. Remove the instruments and package them forsterilization or place on trays if sterilizingunwrapped. Do not rinse or wipe instrumentsprior to sterilization.

Preparing Items for Sterilization

General Preparation Guidelines1. Clean items thoroughly before placing them in the

sterilizer. Follow good laboratory or medical proce-dures for cleaning and decontamination of items.

2. Place absorbent paper or linen towel in the bottomof trays before use.

3. Unwrapped goods should only be processed ontrays. Do not place items on the rack or the bottomof the sterilizer.

4. Liquids must not exceed 75% of capacity of flask.Use self-venting caps.

5. Open all hinged instruments.


NoteDo not place carbon steel instru-ments directly onto stainless steeltrays. Place an unbleached towelor paper wrap on the tray andplace the instruments on the towelor paper.

When wrapping instruments forsterilization, use a material whichpromotes drying.

27

6. Remove the covers from empty containers. Standthe containers and covers on their sides.

7. Turn curved vessels upside down so no water willcollect in the vessel.

8. Place all sharps (knives, scissors, etc.) so thatthey do not touch during sterilization. Cotton orgauze may be used to isolate and protect thesharp edges and the smaller instruments.

9. Disassemble syringes if possible.

10. Do not plug syringes or needles.

Items to be Sterilized Loose andUnwrappedItems to be sterilized loose and unwrapped should be distrib-uted in a single layer on the bottom of a lined, perforated tray.Do not overload tray; allow space around instruments forsteam circulation.Metal and glass canisters and containers should be placed

upside down on a perforated tray. Make sure containers areplaced so that they will drain, or they will not dry sufficiently toensure sterilization.


CautionDo not mix different metals in thesame pack or wrapping or looseon the same tray. Instrument dam-age will result.

Appropriate Wrapping Materials for SteamSterilization (Partial List)

Muslin (2 layers), Nylon bagging material,Commercial autoclave paper (must be as permeableas muslin), Permeable paper and plastic bags, Clothor paper-covered trays

Materials Inappropriate for Wrapping for SteamSterilization (Partial List)

Canvas, Impermeable plastics, Aluminum foil,Sealed jars, canisters or tubes.

WarningUnwrapped items cannot be con-sidered sterile once removed fromthe sterilizer chamber.

Do not overload the trays.Overloading trays may result ininadequate sterilization andunsterile instruments.

NoteUnwrapped trays are usedfor sterilizing nonsurgicalinstruments, canisters andother items to prevent trans-mitting infectious disease.

28

Items to be Sterilized WrappedCleaned items may be wrapped individually in autoclavepaper or placed in commercially prepared autoclave bags. Donot wrap tightly. Seal with autoclave tape or heat sealer.Cleaned items may also be sterilized as a group of instru-

ments wrapped together. You may desire to wrap a group ofsimilar instruments together, or you may desire to wraptogether the instruments needed for a particular procedure.Wrap the instruments loosely in 2 to 4 layers of autoclavepaper or muslin or place them in autoclave bags. Seal withautoclave tape or heat sealer.Place wrapped items on a perforated tray. Do not overload

tray; allow space around wrapped items for steam circulation.When using commercial sterilization bags, follow the

manufacturer's instructions for proper use.

WarningDo not wrap packs tightly and donot over fill autoclave bags. Steammust penetrate through entirepack. Inadequate sterilization mayresult from improper packaging.

Do not seal with staples, pins orother methods which will puncturethe wrapping material. If wrappingmaterial is punctured, sterility can-not be assured once items areremoved from the sterilizer cham-ber.


NoteIf you desire to include a largenumber of instruments in a singlepackage, see Items to beSterilized in Packs.






29

Items to be Sterilized on Wrapped TraysPlace cleaned items loose in the bottom of a lined, perforatedtray. Additional layers of instruments may be added, separat-ed by fabric. Do not overload the tray; steam must be able topenetrate through the entire tray. Wrap the tray in 2 to 4 lay-ers of muslin or other appropriate wrapping material. Sealwith autoclave tape.

Items to be Sterilized in PacksUse packs to sterilize a number of instruments together, tosterilize textile products and to sterilize surgical gloves. Whenusing commercial sterilization packs, follow manufactur-er's instructions for proper use.InstrumentsLoosely package cleaned instruments into packs of not

more than 10 instruments each. Instruments which might nesttogether should be separated by a layer of absorbent materialand placed in the pack in a manner that will allow water toflow out of them. Seal with autoclave tape or heat sealer.Textile ProductsLaunder textile products before sterilization.Loosely roll or fold textile products. Place in commercially

prepared packages or wrap in 2 to 4 layers of muslin or otherappropriate wrapping material. Seal with autoclave tape orheat sealer.Surgical GlovesDisposable gloves should not be sterilized.Clean and dry gloves. Place a piece of muslin or other


WarningDo not seal with staples, pins orother methods which will puncturethe wrapping material. If wrappingmaterial is punctured, sterility can-not be assured once items areremoved from the sterilizer cham-ber.

Do not wrap items tightly and donot over fill autoclave bags. Steammust penetrate through entirewrapped group. Inadequate steril-ization may result from improperwrapping.






30

absorbent material into the central area of the glove. Place astrip of muslin or other absorbent material around the cuff andfold the cuff back over it. Wrap the gloves in muslin or otherappropriate wrapping material. Seal with autoclave tape.Place packs on a perforated tray. Place packs of gloves so

that the glove stand on end in the sterilizer. Load packs side-by-side; do not stack packs.

Preparing Liquids for SterilizationPlace liquids in heat-proof containers. Place containers onperforated tray. Do not fill flask more than 75% full.

Items to be Sterilized in Optional CyclePlace material to be sterilized in appropriate containers or ontrays prior to placement in sterilizer. Follow instructions ondisplay for setting cycle time, temperature and drying para-meters. If running a liquid-optional cycle, ensure that contain-ers are not more than 75% full. User must follow proper safe-ty procedures and sterilization monitoring procedures for theoptional cycle. Every optional cycle should be validated bythe user.Dental handpieces should be run at 132°C for 10 minutes.


CautionDo not use detergents with a highchlorine or phosphate content orchlorine bleach when launderingitems prior to sterilization. Damageto instruments and to the sterilizerchamber could result.

WarningDo not overload tray; allow spacearound packs for steam circula-tion. Pack density should notexceed 50% of the capacity of thetray. Metal or glass should not beused to separate packs, as thesewill inhibit drying. Overloading thetray or failure to allow the packs todry properly can result in non-ster-ile goods.

WarningDo not exceed the sterilizer's ratedcapacity for liquid sterilization.Non-sterile liquids could result. Fillflasks no more than 75% full. Usershould validate material in optionalcycle.

NoteUser should not attempt to sterilizemore than 10 handpieces per ster-ilization cycle.

31

Loading the Sterilizer Chamber

Loading Guidelines1. When processing wrapped goods, fabrics and

dressings, always place items in one of the threeupper positions in the chamber. Processing itemsin the bottom position could possibly result in wetpacks and unsterile goods.

2. Do not exceed the specified loads for a cycle:Unwrapped Goods - no more than 14 lbsWrapped Goods - no more than 14 lbs in no morethan 12 small cassettes or 4 large cassettesPacks - no more than 2.8 lbs and no more than 14towelsLiquids - flasks filled no more than 75% full.

3. Do not overload the sterilizer. Steam penetratesbest with loosely packed loads.

4. Do not allow packs or wrappings to touch chamberwalls or one another.

5. Leave adequate space between trays to allowsteam circulation.

6. Do not stack trays on top of one another.

7. Use a process monitor in each load. We also rec-ommend that you use a biological indicator atweekly intervals. An indicator containing Bacillusstearothermophilus is the proper indicator forsteam sterilizers.


WarningUse only self-venting, automaticsealing stoppers when processingliquids or media. Use of otherstoppers or seals, or lack of stop-pers, will create the possibility ofburns or injury from boiling liquidsand exploding flasks.

If media is processed, bottles andtubes should contain no morethan 3/4 the total volume of thecontainer. When processing waterbottles and test tubes, the bottlesand tubes should contain no morethan 3/4 the total volume of thecontainer. Chamber should becleaned daily when processingmedia.

Sterilized liquids are fornon-clinical applications.

CautionPacks must be centered in thechamber. Do not allow packs totouch the sterilizer chamber'swalls. Allowing packs to touch thesterilizer chamber's walls may cre-ate an overheat condition.

32

Handling Sterilized MaterialsLoads may be removed from the sterilizer at the end of thedrying cycle. (Liquids may be removed at the end of the steril-ization cycle.) Unwrapped items should be used immediately.Any unwrapped items not used immediately cannot be con-sidered sterile after removal from the sterilizer chamber.Date all wrapped packages and packs prior to storage.

Check the integrity of all wrapping materials prior to openingand using wrapped or packed items; if the wrapping materialsare opened or torn, the instruments must be consideredpotentially unsterile and should be re-sterilized prior to use.Re-sterilize all wrapped packages and packs after one monthin storage.


WarningSterilizer and trays will be hotafter cycle is run. Always wearprotective gloves and apron whenremoving a processed load.Protective gloves and apronshould also be worn when reload-ing sterilizer following previousoperation.

Open door slowly at the end of aliquid sterilization cycle. Do notallow hot bottles to be jolted. Thiscan cause bottle explosions. Donot move bottles if any boiling orbubbling is present.

Allow bottles to cool beforeattempting to move them fromsterilizer shelf or tray(s) to thestorage area.

33

Recommended Monitoring

NoteRefer to the manufacturer's recom-mendations for proper use of biologi-cal indicators.

All functions of a sterilizer should be monitored to providemaximum assurance of proper performance.

Process MonitoringFor assurance that minimum sterilizing conditions have beenachieved, we recommend the use of a process monitor witheach cycle and within each package. This small processmonitoring device will provide immediate indication of expo-sure to temperature and of time in the presence of humidity(steam).

TraysPlace a process monitor in the center of each wrapped orunwrapped tray of loose items.

Wrapped InstrumentsPlace a process monitor inside each package with an instru-ment.

Wrapped Packages of InstrumentsPlace a process monitor in each package.

PacksPlace a process monitor inside each pack. When sterilizingtextile products, place the process monitor in the center ofthe stack of textile products. When sterilizing gloves, place aprocess monitor inside a glove inside each pack.

34

RECOMMENDED MONITORING

NoteWhen using a biological indicator for a135°C cycle, the user must be sure thatit has been validated for use at 135°C.We recommend using the ThermoScientific Biological Indicator (part #AY759X1) for this type of cycle. If anyother Biological Indicator is used, theuser must ensure that it has been vali-dated for a 135°C cycle.

NoteRefer to the manufacturer's recommenda-tions for proper use of biological indica-tors.

Biological IndicatorsProcess monitors do not by themselves prove steriliza-tion has occurred. Biological indicators composed ofspores of standard organisms are considered the mostreliable means of verifying sterilization. A biological indi-cator functions by testing the sterilizer's ability to kill testorganisms of a known high resistance. Indicators con-taining Bacillus stearothermophilus should be used forsteam sterilizers. The Joint Commission onAccreditation of Hospitals recommends that biologicalindicators be used at least weekly to check the effective-ness of your steam sterilizer's sterilization cycle.When testing the effectiveness of a sterilization cycle,

use the appropriate "worst case" test load described forthe cycle in this section:

Unwrapped InstrumentsPlace 100 instruments on a perforated tray lined with a100% cotton surgical towel. Place a biological indicatorin the center of the test tray. Place the test tray in thecenter rack of the sterilizer chamber. Prepare additionaltrays in the same manner without biological indicators tobring the total sterilization load to 14 lbs (6.4 kg).

Wrapped InstrumentsLoad a small cassette with 6 instruments. Place two bio-logical indicators inside the cassette. Wrap the cassettewith two layers of appropriate wrapping. Seal with auto-clave tape. Prepare eight other small cassettes in thesame manner without the biological indicators. Place thecassette with the biological monitor upright in the centerof a tray. Fill the tray with the rest of the cassettes.Place the tray in the center rack of the sterilizer cham-ber.

35

RECOMMENDED MONITORING

Packs

TextilesPrepare a pack of 14 towels (per AAMI ST-8). Place threebiological indicators in the center of the pack, between thesixth and seventh towels. Wrap the pack with two strips ofautoclave tape, placing the tape around the width of thepack so that the two strips divide the length of the packinto thirds.

PouchesPlace a biological indicator together with a surgical instru-ment into a self-sealing pouch. Place the pouch with theindicator in the middle of the tray. Place four other surgicalinstruments into pouches and place them on the tray.Place the tray in the center rack of the sterilizer chamber.

Optional Cycle: For Dental Handpieces OnlyPlace a biological indicator together with one dental hand-piece in a self-sealing pouch. Place the closed pouch inthe front of the sterilizer tray. Place the tray in the lowestlevel of the chamber rack.

36

Operation

Connect the power cord to the unit and to a grounded outletof appropriate voltage and rating.

Initial Startup

Power OnPush the Power Switch under the right front corner of thesterilizer to the On position. The sterilizer will not operateunless this switch is in the On position.

Filling ReservoirRemove the cover to the water reservoir and fill the reservoirwith distilled or low quality deionized water (minimum 0.5Megohm/cm, maximum 1.5 Megohm/cm) until the water levelreaches the bottom of the fill line in the reservoir. The reser-voir will hold approximately 7.0 liters (6.3 quarts) of water.The water level should never be higher than the fill line. Donot overfill.

Refilling ReservoirWhen the reservoir runs low on water, the low level sensorwill alert you of the low water condition. When the displayindicates "Reservoir is empty. Fill and restart sterilizationcycle," you will need to add water to the reservoir before yourun another cycle. You should never need to add more than 5liters (5.3 quarts) at a time to the reservoir. The water levelshould never be higher than the fill line. Do not overfill.You may determine a refill schedule dependent upon the

pattern of operation at you facility. The number of cycles youcan run before the reservoir needs to be filled will varyaccording to your frequency of operation, duration betweencycles, type of cycles, etc.

WarningKeep patients at least six (6) feetaway from the sterilizer when it isin use.

Do not operate this sterilizer in thepresence of flammable or explo-sive substances (such as anes-thetics). A fire or explosion couldoccur.

CautionTo prevent collection of mineraldeposits and corrosion of chambercomponents, use distilled or deion-ized water only. See Specifications.Clean chamber after each use ifsterilizing saline solutions.

Do not overfill reservoir. To avoidslippery conditions and possibleload recontamination, immediatelywipe up all spillage resulting fromoverfilling chamber or reservoir.

WarningDo not add water to reservoirwhile a sterilization cycle is inprocess. When the cycle ends andsteam vents back into the reser-voir, a sudden overflow of hotwater could occur, possibly result-ing in burns to personnel.

37

OPERATION

Outline of OperationTwo basic steps are required to initiate a sterilizing cycle afterthe load has been placed in the chamber and the door closedand latched:1. Select the cycle you desire.

2. Follow the displayed directions for the cycle.

Cycle selections cannot be changed once "StartCycle" has been pressed. To change a setting, thecycle must be terminated by pressing "Stop." Whenyou select a new cycle, the cycle information will bechanged automatically.

Details of Operation

Prepare LoadFollow preparation instructions on pages 27-31.

Load the Sterilizer ChamberYou may load wrapped or unwrapped instruments, linen packs,glassware and liquids. Follow loading instructions on page 33.

Close the Sterilizer DoorThe door must be fully closed to run a sterilizing cycle. If thedoor is not fully closed, the sterilizer will stop and indicate, "Thedoor is open. Close door to continue cycle."

Select Processing Cycle1. Select your required cycle.

2. Set the drying cycle time for pack, wrapped andunwrapped cycles. (See "Drying Sterilized Loads.")

38

WarningUse caution when opening thesterilizer door. Stand to the sidebehind the door and open doorslowly and partially to protectyourself from escaping steam orboiling liquids and explodingflasks.

Do not attempt to open sterilizerdoor until the display reads "CycleComplete." Pressure within thechamber could cause the door toopen with extreme force, possiblycausing personal injury.

OPERATION

WarningProcessing goods at less than rec-ommended time/temperaturecould result in unsterile goods.

Setting Drying Time

(For Pack, Wrapped and Unwrapped cycles only.)If drying is desired, set the drying time when you select

the sterilization cycle. After you select a Pack, Wrapped orUnwrapped cycle, the cycle parameters will be displayed.After the parameters have been displayed, you will beprompted to enter a figure for drying time. You will find thatthe default time — displayed at the prompt — is the opti-mal setting for most loads.If your application or load composition requires a differ-

ent drying time to achieve appropriate drying, you canchange the drying time setting when the display promptsyou. Use the up or down arrow to adjust the displayed dry-ing time until your desired drying time is displayed.

Press "Start Cycle"Processing will run automatically after you press "StartCycle."

Drying Sterilized LoadsAt the completion of the sterilization cycle, turn the lock-

ing handle counter clockwise until the door is held in placeby the backup catch. The door must be opened approxi-mately 1 inch to operate the drying cycle. To prevent con-tamination of wet packs and wrapped items, do notopen the door more than 1 inch during the dryingcycle. Press "Start Cycle" to start the drying cycle.When you press "Start Cycle," the Drying Indicator will

be displayed, the chamber will heat to a low temperatureand the selected drying time will begin to count down. Atthe end of the drying cycle, a five second alarm will sound.

Optional Drying CyclesIf you desire to run a drying cycle without running a

sterilizing cycle with it, you may. Press the "OptionalCycle" button and scroll the setpoint temperature below100°C. You will enter a menu for an optional drying cycle.Set the drying time as instructed above, then press "StartCycle" to begin the drying cycle.

39

The optional printer provides a paper tape record for futurereference and verifies sterilizer performance, load controlidentification and quality assurance checks for each cycle.

During a sterilization cycle, the printer prints a record of thechamber temperature, pressure and status of the cycle at 1-minute intervals.

Connecting and Starting thePrinter

1. Make sure the printer and sterilizer areturned OFF.

2. Connect the enclosed data cable to theRS232 connector on the back of the steriliz-er and the power cord to the power supply.

3. Turn the printer ON.

4. Turn the sterilizer ON. The printer shouldprint "Barnstead/Thermolyne Sterilemax,""Software Version X.XX.XX"

5. If the printer does not print heading, verifythe "Printer Mode" is set to used. See"Changing Printer Mode."

6. Turn the sterilizer off and then back on toverify the printer prints out"Barnstead/Thermolyne Sterilemax,""Software Version X.XX.XX"

7. The printer is now ready to print.

Control Panel (See Figure B)

Power SwitchLocated on the front of the printer, this switch turns power tothe printer ON and OFF. (See Figure A.) The green POWERlight will illuminate when the printer is ON.

Optional Printer

Figure A: Printer

ON/OFF Button

Figure B: Control Panel

Paper Feed Button

Paper Out LightError Light

Power Light

40

PRINTER

Paper Feed ButtonPress this button once to advance the tape one line, or holdthe button down to advance paper continuously. When thepaper roll nears the end, the red PAPER OUT light will illumi-nate.

If the red ERROR light illuminates, the printer is off line. Thiscould be a result of the print head being too hot, in whichcase the printer will resume printing once it cools down; or—the paper may be jammed in the printer. Turn the printer OFFbefore checking for jammed paper. Remove the paper jamand turn the printer back ON. If the printer still will not print,unplug it and refer servicing to qualified personnel.

Installing the Paper RollWhen the red PAPER OUT light illuminates, it is time toreplace the paper roll. Replace the paper (AY669X4) roll asfollows:1. Turn the printer ON and open the cover.

2. Make sure the edge of the paper roll is straight.

3. Insert the paper roll into the printer. (See FigureC.)

4. Insert the paper straight into the paper slot (seeFigure D). The paper will feed automatically.

5. Tear off a strip of paper and close the cover. (Thered PAPER OUT light will be OFF if paper rollinstallation is successful.)

Printer OperationThe printer automatically records sterilization cycles. Duringsterilization cycles, the printer prints the chamber tempera-ture, pressure and status of cycle at one minute intervals.

Figure C: Inserting the Paper Roll

Figure D: Inserting the Paper Into thePaper Slot

NoteA colored stripe along the edge ofthe paper indicates that you areapproaching the end of the tape.When the stripe appears, approx.23 inches of paper remain, enoughfor 2-3 cycles. Replace the tapebefore it is completely exhaustedto ensure a complete record ofyour sterilization procedures

41

Printer Tape DescriptionThe printer tape is designed to be easily read as a cycle isrunning, allowing you to exam at a glance the progress of thecurrent cycle. As a result, a complete tape must be read fromthe bottom up. (Sample on page 41)When you turn on the sterilizer, the printer will print

"Barnstead|Thermolyne Sterilemax" and the software versionnumber. This will print only immediately after the sterilizer hasbeen turned on.When you press one of the preset cycle buttons, the print-

er will print the name of the cycle selected, the parametersset for that cycle and the selected pressure units. If youchoose a default optional cycle, the printer will print the cur-rent default parameters. If you bypass the default optionalcycle for a standard, the printer will print only the name of thecycle and the selected pressure units, since the parametershave not been set.When you press "Start Cycle", the printer will print the

number of cycles that have been run since the unit wasturned on, the current date and time, the notation "CycleStarted" and column headers.During the cycle, the printer will print the elapsed time, the

current chamber temperature and the current chamber pres-sure at one minute intervals, along with a status notation.When you press "Start Cycle", the printer will print the num-ber of cycles that have been run since the unit was turned on,the current date and time, the notation "Cycle Started" andcolumn headers.During the cycle, the printer will print the elapsed time, the

current chamber temperature and the current chamber pres-sure at one minute intervals, along with a status notation.When the sterilizer chamber achieves the temperature set

by the cycle parameters, the printer will immediately print arecord line, regardless of the time since the last record wasprinted. The status notation will change from "Heatup" to"Exp", indicating that the load is being exposed to the temper-ature set forth in the cycle parameters. The printer will contin-ue to print record lines at one minute increments, starting oneminute after the record line printed at the start of the expo-sure phase but still showing the total elapsed time for thecycle.

Default Optional Cycle Printout

PRINTER

42

PRINTER

When the sterilizer has achieved the time condition set inthe cycle parameters, the printer will print "Vent" in the cyclestatus column, indicating that the sterilizer is venting.At the end of the vent phase, the printer will print "Venting

Cycle Completed" and instructions for starting the dryingcycle. There is no printout during the drying cycle.

Printer Record StorageTo ensure the long-term legibility of yourrecords, it is important that you keep yourprinted tapes in a dry, cool, dark place.

43

Name of preset program chosen forthis cycle

Parameters for this programmed cycle(default for this preset program)

Currently chosen pressure units

Date and time of cycle initiation

Cycle record number for day

Column Headers

Elapsed time since cycle started

Chamber Temperature

Chamber Pressure

Current status of the cycle

Exact point at which sterilizationphase begins.

Elapsed time increments by minutesfrom start of sterilization phase

Instructions for drying

End of cycle

VentPhase

ExposurePhase

HeatupPhase

Printer Mode is (USED)

Version X.XX.XXSterilemax

Barnstead|Thermolyne

Software version number printswhen you turn on the sterilizer.

PRINTER

44

WarningDo not attempt to open sterilizerdoor until the display reads "CycleComplete". Pressure within thechamber could cause the door toopen with extreme force, possiblycausing personal injury.

Reprocess your load in the eventthe sterilizing cycle has been ter-minated prematurely. The loadmay not be sterile when the steril-izing cycle has been terminatedprematurely.

Failure to drain excess water fromthe sterilizer chamber after a cycleabort may result in subsequentunsterile loads as a result of con-tact with water in the chamber.Always drain excess water fromthe chamber after aborting a cycle.

Allow chamber to cool beforedraining excess water.

NoteIf display shows: "The MechanicalOTP has Tripped. Shutoff UnitPower and Reset - Caution - UnitHot!!" Reset as described under"Resetting the Mechanical OTPSensor" in Service Manual.

Emergency Off (Cycle Abort)Pressing the "Stop" button will immediately terminate steriliza-tion. Allow the sterilizer to cool and press the "Stop" buttonagain to reset the sterilizer. Drain excess water from the ster-ilizer chamber. Proceed with a new sterilization cycle normal-ly.When terminating a load, pressing the "Stop" button will

vent steam from the chamber back into the reservoir.

Resetting the Automatic OTPDisplay shows: "Cycle Aborted Due to AUTO OTP Device.Press Stop Shutoff Unit Power to Reset."1. Press the "Stop" button.

2. Wait for the display to read "Select Cycle".

3. Turn Power Switch off and then on to reset theLow Water Cutoff.

4. Open the chamber door and allow the chamber tocool.

5. Select your desired cycle and run the cycle with aloaded chamber to verify operation.

6. In the event of a repetition of fault call CustomerService.

Special Operating Conditions

45

SPECIAL OPERATING SITUATIONS

WarningReprocess your load in theevent the sterilizing cycle hasbeen terminated prematurely.The load may not be sterilewhen the sterilizing cycle hasbeen terminated prematurely.

WarningReprocess your load in theevent the sterilizing cycle hasbeen terminated prematurely.The load may not be sterilewhen the sterilizing cycle hasbeen terminated prematurely.

Erratic Controls Display orOperationAbnormal sterilizer operation or controls display could be

caused by an internal or external electrical voltage surge.Such a voltage surge could be cause be any of a number ofevents: a momentary surge in the power supply, a nearbylightening storm, or even a static electrical charge carried byoperating personnel.Abnormal operation or displays are not common occur-

rences and may never happen. No damage to the equipmentwill occur if such an event should happen.If an abnormal condition should occur, terminate any pro-

cessing cycle in process. (Press "Stop.") Reset the sterilizerby turning the power switch (on the front right corner of theunit) to OFF. Wait 30 seconds and turn the power switch backon. Select your desired cycle and proceed with normal opera-tion.

Power Failure During SterilizingCycleAll Selector/Indicator Panel lights will be off.Allow the unit to cool. Reset the sterilizer by turning the

power switch (under the front right corner of the unit) to OFF.Wait 30 seconds and turn the power switch back on. Drainexcess water from the sterilizer chamber. Then reprocessyour load normally.

46

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115

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47

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International

International

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thepower supply Power Supply

48

Maintenance Schedule Chart

*When processing liquid loads

Maintenance Required Person Responsible

Daily

Clean Door Gasket User

Clean Chamber* User

Weekly

Clean Chamber, Trays and Rack User

Monthly

Check Pressure Relief Valve Qualified Service Personnel

Clean Reservoir User

Yearly

Temperature Readout Verification Qualified Service Personnel

As Required

Install Paper Roll User

Changing Door Gasket Qualified Service Personnel

49

WarningRefer servicing to qualified person-nel.

Never use a wire brush, steelwool, abrasive material, or chlo-ride-containing products to cleandoor and chamber assembly.

"Caution: Hot Surface. AvoidContact." Ensure that the sterilizeris cool before cleaning to avoidburns.

CautionFailure to keep the interior of thestainless steel chamber free ofmineral deposits and debris cancause premature failure of thesterilizer.

WarningTo prevent collection of mineraldeposits and corrosion of chambercomponents, use distilled or deion-ized water only as specified. Cleanchamber after each use if steriliz-ing saline solutions.

Maintenance

Daily Maintenance

Cleaning Door GasketThe door gasket and the mating surface should be wipedclean each day with a clean, damp cloth. Do not use abra-sive cleaners on the gasket or mating surface.

The gasket should be examined for cracks and dam-age that could result in a poor pressure seal. If replacementis necessary, refer to Gasket Replacement under the WhenRequired heading of this Maintenance section.

Cleaning After Liquid LoadsBiological media tends to boil at a higher rate than other liq-uids during venting. This causes media to be spattered insidethe chamber. Therefore, the chamber must be cleaned dailywhen you are sterilizing media. Clean as follows:1. Allow unit to cool.

2. Wipe out chamber and door with a clean, dampcloth.

Weekly Maintenance(More often if necessary.)

Cleaning Chamber, Trays and RackAt least once a week, the trays and tray rack should beremoved from the sterilizer chamber. The trays, tray rack andchamber should be thoroughly cleaned to remove anydeposits from the surfaces.Clean the trays, rack and chamber (especially the bottom ofthe chamber) with appropriate anti-biological cleaners. Wipeall residue from the surfaces with a dampened, lint-free cloth.

50

NoteIn the event that you have lost thesupplied drain tubing, you candrain the reservoir as follows:

1. Tilt the front of the sterilizer upuntil you can access the smallpanel on the bottom front of thesterilizer, beneath the drainassembly.

2. Remove the screws securing thepanel. Remove the panel.

3. Have a suitable container pre-pared for the water in the reser-voir. Disconnect the reservoir draintube from the quick disconnect fix-ture on the front of the sterilizer.The reservoir will drain.

NoteDo not add more than 7 liters ofwater to the reservoir after cleaning.

MAINTENANCE

WarningPressurized steam will be dis-charged when the relief valve isopened. To prevent burns, place asteam barrier (such as a rolledtowel) around the opening in theback of the unit. To prevent burns,wear gloves or use an extensiondevice if it becomes necessary tooperate the pull ring.

Monthly Maintenance

Pressure Relief Valve CheckTo ensure that the pressure relief valve is functioning proper-ly, you must have a qualified person check the valve eachmonth.

The pressure relief valve is located on the pressureline in the back of the unit and is accessed through a roundaccess hole in the back panel. A suitable tool (screwdriver,rod, etc.) will be needed to test the pressure valve.1. Run a sterilize cycle at 135°C (275°F) without a

load in the chamber.

2. Allow the pressure in the chamber to reach 30 psi(206 kPa).

3. Insert a suitable tool through the access hole andpush the lever on the pressure relief valve. Pushthe valve lever away from the valve to open thevalve. Hold the valve open for 3 seconds. Steamshould discharge freely.

4. Release the valve lever. The steam dischargeshould cease entirely.

5. After checking the valve, turn the sterilizer off bypressing "Stop" to prevent overheating.

If the valve malfunctions, the valve must be replaced.

Cleaning Reservoir1. The reservoir drain assembly is located on the

lower right front side of the sterilizer cabinet. Placea suitable container below the drain assembly.Connect the drain adapter and tube to the drainassembly and drain the reservoir into the contain-er.

2. When the reservoir is empty, wipe out the inside ofthe reservoir with a clean, lint-free cloth. Take carenot to push debris back into the water line.

3. Refill the reservoir with distilled or low qualitydeionized water (minimum 0.5 megohms/cm, maxi-mum 1.5 megohms/cm) and replace the reservoircover.

51

MAINTENANCE

WarningBURN HAZARD: Do not empty thecollection bottle when the sterilizer isin operation.

NoteIt is important to periodically checkthe water level in the collection bot-tle. Failure to empty the bottle willresult in water overflowing onto sur-rounding surfaces.

Waste WaterCoolingTank

CollectionBottle

FromSterilizer

OptionalOverflowDrain

Emptying Collection Bottle1. Empty the collection bottle when the water in the

bottle reaches the FULL mark.

3. Slide the bottle away from the cooling tank toremove.

4. Pour the contents down the drain.

52

The non-recirculating water cooling tank should be drainedand rinsed out every six months. Do not clean the tank whenthe sterilizer is in operation.

Using the optional overflow tube (supplied), push the connec-tor fitting into the drain connection at the bottom of the tank toempty it.

Remove the drain tube when the tank is empty, and rinse thetank with a solution of household bleach (3/4 cup) and dis-tilled or deionized water (1 gal.). Drain solution and rinsewith distilled or deionized water before refilling.

Refill the tank with clean distilled or deionized water to put thesystem back in service.

Cleaning Non-Recirculating WaterCooling Tank

WarningBURN HAZARD: Do not clean thetank when the sterilizer is in opera-tion. Allow the non-recirculating cool-ing tank to cool to room temperaturebefore cleaning the tank.

To Empty:Push in overflowtube until it “clicks.”

OptionalOverflowTube

Overflow Drain

TankDrain

To RemoveOverflow Tube:

Press tab to release.

MAINTENANCE

53

MAINTENANCE

Changing Door Gasket1. Disconnect the sterilizer from the power supply.

Ensure that the sterilizer is cool and depressur-ized.

2. Remove the old gasket by pulling it out of thedoor.

3. Use a warm, soapy water combination to lubricatethe gasket for easier installation.

4. Working around the door from one point, insert theouter edge of the gasket under the machined lip ofthe gasket groove in the door.

5. Working around the door from one point, press theinner edge of the gasket into the gasket groove,ensuring that the gasket is fully seated in thegroove.

6. Reconnect the sterilizer to the power supply.

54

Figures

Sterilizer Component Layout - Interior

Power Supply BoardWith Sheild Cover

On/Off Switch(underneath)

Reservoir Cover

Door Release

Door Handle

Membrane Panel

Main Control Board

Pump

Power Module

OTP PC Board

Solenoid PCBoard

55

FIGURES

Sterilizer Component Layout - Chamber and Door

Trays

Rack

Door Interlock

Reservoir Drain

Door Switch

56

FIGURES

Insulation SupportBracket

Sterilizer Component Layout - Top View

Solid State �Relay

OTP Mechanical Relay

Pressure Relief Valve

Calibration Port

Temperature Sensor

Fan

Vent Solenoid

Insulation

Reservoir

Pressure Transducer

Insulation Support Bracket

Door Switch

57

Parts List

120 V 220V~Qty. Description Part No. Part No.1 Printer Ribbon AYX21 AYX211 Printer Paper Tape Roll AY669X4 AY669X42 Solenoid Valve RY759X1A RY759X1A1 Power Supply TNX116 TNX116

PC Board (Solenoid) PC1277X2 PC1277X2Pressure Relief Valve 250052401 250052401Tank, Lower Float SW759X1A SW759X1APC Board (Logic) PC1277X1 PC1277X1ON/OFF Switch SWX141 SWX104Terminal Strip TRX177 TRX177Relay Contact RYX60 RYX60Pump PUX16 PUX16Door Gasket GS759X1A GS759X1AFan FA981X1A FA759X1AHeater ELX9 ELX10Gasket (Chamber) GS759X4 GS759X4Relay, Solid State RYX34 RYX34PC Board (OTP) PC1118X2 PC1118X2Tray (Large) TY759X2A TY759X2ATray (Small) TY759X3A TY759X3ADoor Switch SW1118X1 SW1118X1Membrane Panel SW759X3 SW759X3Water Reservoir TY759X1 TY759X1Safety Latch SF759X1A SF759X1AShaft Ass'y (Main Door Latch) SF759X2A SF759X2APressure Pin (Door) SP759X1 SP759X1

2 Handle (Yoke Assembly) HNX18 HNX181 Drain Tube Assembly TU759X9A TU759X9A

Reservoir Cover DL759X2 DL759X2Chamber Temp. Sensor RS1277X1 RS1277X1Automatic OTP Sensor RS759X2A RS759X2AMechanical OTP Sensor FZ759X1 FZ759X1

1 Pressure Transducer TDX5 TDX5Fuse for TBX116 AZ9027 AZ9027

WarningReplace fuses with same type and rating

58

Ordering Procedures

Please refer to the Specification Plate for the complete modelnumber, serial number, and series number when requestingservice, replacement parts or in any correspondence con-cerning this unit.

All parts listed herein may be ordered from the ThermoScientific dealer from whom you purchased this unit or canbe obtained promptly from the factory. When service orreplacement parts are needed we ask that you check firstwith your dealer. If the dealer cannot handle your request,then contact our Customer Service Department at 563-556-2241 or 800-553-0039.

Prior to returning any materials, please contact our CustomerService Department for a “Return Materials Authorization”number (RMA). Material returned without an RMA number willbe refused.

59

Decontamination Statement

We cannot accept any product or component sent for repair or credit that is contaminatedwith or has been exposed to potentially infectious agents or radioactive materials.No product or component will be accepted without a "Return Materials Authorization"

(RMA) number.

One Year Limited WarrantyThis Thermo Scientific product shall be free of defects in materials and workmanship for one (1) year from the firstto occur of (i) the date the product is sold by the manufacturer or (ii) the date the product is purchased by the origi-nal retail customer (the "Commencement Date"). Except as expressly stated above, WE MAKE NO OTHER WAR-RANTY, EXPRESSED OR IMPLIED, WITH RESPECT TO THE PRODUCTS AND EXPRESSLY DISCLAIM ANYAND ALL WARRANTIES, INCLUDING BUT NOT LIMITED TO, WARRANTIES OF DESIGN, MERCHANT ABILITYAND FITNESS FOR A PARTICULAR PURPOSE.

An authorized representative of the manufacturer must perform all warranty inspections. In the event of a defectcovered by this warranty, the manufacturer shall, as its sole obligation and exclusive remedy, provide free replace-ment parts to remedy the defective product. In addition, for products sold by the manufacturer within the continen-tal United States or Canada, the manufacturer shall provide free labor to repair the products with the replacementparts, but only for a period of ninety (90) days from the Commencement Date.

The warranty provided hereunder shall be null and void and without further force or effect if there is any (i) repairmade to the product by a party other than the manufacturer or its duly authorized service representative, (ii) misuse(including use inconsistent with written operating instructions for the product), mishandling, contamination, over-heating, modification or alteration of the product by any customer or third party or (iii) use of replacement parts thatare obtained from a party who is not an authorized dealer of Thermo Scientific products.

Heating elements, because of their susceptibility to overheating and contamination, must be returned to the factoryand if, upon inspection, it is concluded that failure is due to factors other than excessive high temperature or conta-mination, the manufacturer will provide warranty replacement. As a condition to the return of any product, or anyconstituent part thereof, to the factory, it shall be sent prepaid and a prior written authorization from the manufactur-er assigning a Return Materials Number (RMA) to the product or part shall be obtained.

IN NO EVENT SHALL THE MANUFACTURER BE LIABLE TO ANY PARTY FOR ANY DIRECT, INDIRECT, SPE-CIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, OR FOR ANY DAMAGES RESULTING FROM LOSS OFUSE OR PROFITS, ANTICIPATED OR OTHERWISE, ARISING OUT OF OR IN CONNECTION WITH THE SALE,USE OR PERFORMANCE OF ANY PRODUCTS, WHETHER SUCH CLAIM IS BASED ON CONTRACT, TORT(INCLUDING NEGLIGENCE), ANY THEORY OF STRICT LIABILITY OR REGULATORY ACTION.

For the name of the authorized Thermo Scientific dealer nearest you or any additional information, contact us:2555 Kerper Blvd., Dubuque, Iowa, 52001-9918Phone: 563-556-2241 or 1-800-553-0039

Fax: 563-589-0516E-mail: [email protected]

Web: www.thermo.com

Business

Sterilemax operation