Amsco Eagle 3017 Operator Manual (1)

iOperating Instructions 129353-701

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OPERATOR MANUAL

Amsco® Eagle® 3017100% EO Sterilizer/Aerator

(05/24/01) P129353-701

iIntroduction Operator Manual 129353-701

A WORD FROM STERIS CORPORATION

© 2001 STERIS All rights reserved. Printed in U.S.A.

IMPORTANT: A listing of the Safety Precautions to be observedwhen operating and servicing this equipment and/or handlingthe Envirosystems® Ethylene Oxide Sterilant cartridges can befound in Section 1 of this manual. Do not operate or service theequipment or handle the EO cartridges until you have becomefamiliar with this information.

Thank you for choosing this fine STERIS product. You may be confident ofour continued interest in your satisfaction with it. This manual containsimportant information on proper use and care of the Amsco® Eagle® 3017100% EO Sterilizer/Aerator. All personnel involved in the use andmaintenance of this equipment must carefully review and comply withthe dangers, warnings, cautions, and instructions contained in thismanual, in the Material Safety Data Sheet (MSDS), and in the STERISSafety Guidelines publication M1846 (P62942-091). These instructionsare important to protect the health and safety of personnel operating AmscoEagle 3017 Sterilizer/Aerators and should be retained in a convenientlyaccessible location for quick reference.

This sterilizer is specifically designed to process goods using only thecycles as specified in this manual. If there is any doubt about processinga specific material or product, contact the manufacturer of the product forthe recommended sterilization and aeration techniques.

A STERIS representative will gladly review the requirements for accessoriesand EO monitoring products for use with this unit with you.

A summary of the Safety Precautions to be observed when operating thisequipment can be found in Section 1 of this manual. Do not operate or servicethe sterilizer until you have become familiar with this information.

Any alteration of the unit or addition of unauthorized equipment which affectsits operation will void the warranty, could adversely affect sterilizationefficacy, could violate federal, state, and local regulations, and mayjeopardize your insurance coverage.

Amsco Eagle 3017 100% EO Sterilizer/Aerator, is designed for use on itemssensitive to moisture and/or heat which cannot be sterilized by steam or dryheat.

Items should always be sterilized in accordance with the sterilized productmanufacturer’s recommendations.

Items listed by the sterilized product manufacturer not to be exposed toethylene oxide are specifically prohibited.

Indications for Use

Advisory

ii129353-701 Operator Manual Introduction

DANGER - ETHYLENE OXIDE (EO): TOXIC. POSSIBLE CANCER,REPRODUCTIVE, AND EXPLOSION HAZARD:

Possible Hazards of Ethylene Oxide:

The Occupational Safety and Health Administration has concluded that chronic and/or acute exposure to EO may increase the risk of serious adverse health effects.

OSHA has concluded that EO is or may be associated with the following: cancers ofthe blood (leukemia), brain and other organs; mutations, increases in the rate ofchromosomal aberrations and sister chromatid exchanges and other undesirablechanges in the DNA of mammalian cells; adverse reproductive effects in both men andwomen; central nervous system depression and other adverse neurological effects;sensitization and irritation of human tissues, including the eyes and respiratory tract;pulmonary edema; bronchitis; headaches; nausea; vomiting; diarrhea; cyanosis;drowsiness; weakness; and incoordination.

In addition, OSHA has concluded that contact with liquid EO can cause swelling andburns of human skin; frostbite; eye irritation; and injury to the cornea. Possible healtheffects of exposure to EO are continuously being investigated by the medical andscientific communities, and it is possible that in the future OSHA may conclude thatEO may be associated with other adverse health effects.

STERIS strongly recommends that its customers review the current OSHA regulationspertaining to EO exposure in order to obtain a thorough understanding of the methodsprescribed by OSHA to reduce the risks of worker exposure to EO.

STERIS also provides personnel and area monitoring systems to measure EOconcentrations and exposure levels.

100% EO is highly flammable and combustible and presents an explosion and firehazard. All necessary precautions should be taken to reduce the risk of explosion andfire.

Service InformationA thorough preventive maintenance program is essential to safe and propersterilizer/aerator operation. This manual contains maintenance schedulesand procedures which should be followed for satisfactory equipmentperformance.

You are encouraged to contact STERIS concerning our comprehensiveAnnual Maintenance Agreements. Under terms of these agreements,preventive maintenance, adjustments, and replacement of worn parts aredone on a scheduled basis to assure sterilizer/aerator performance at peakcapability and to help avoid untimely or costly interruptions. STERISmaintains a global staff of well-equipped, factory-trained technicians toprovide this service, as well as expert repair services. Contact STERIS fordetails. Comprehensive instructions for yearly preventive maintenance canbe found in the Service and Maintenance Procedures Manual (P129353-707), available from STERIS.

iiiIntroduction Operator Manual 129353-701

Amsco Eagle 3017 100% EO Sterilizer/Aerator

Sterilizer accessories shipped with unit consist of:Two Baskets,

One Compressed Air Filter,One Refrigreated Air Dryer (Not Shown)

ElectricPowerSupply

MainPowerSupplySwitch

EO Exhaust To RoofVent, or EO Disposer

Connector forEO Disposer, AreaMonitor, MagData®

AirSupply

Printer Door(Hinged)

Door Latch

To Facility DedicatedOutside Non-RecirculatingExhaust System

STATU

S

CYC

LE

PRINTE

R

VALUES

1

2

3

4

RESET

PRINT

PAPER

ADVAN

CE

CHAN

GE

VALUES

CURSO

R

VALUE

SAVE

VALUES

vIntroduction Operator Manual 129353-701

TABLE OF CONTENTSSection Title Page

1 LISTING OF SAFETY PRECAUTIONS ................................................... 1-1

2 SAFETY CONSIDERATIONS ................................................................. 2-12.1 Area EO Monitor .................................................................................................................... 2-12.2 Emergency Action ................................................................................................................. 2-12.3 Damaged or Expired Cartridges ............................................................................................ 2-12.4 EO Cartridge Leaks ............................................................................................................... 2-12.5 EO Leaks or Spills ................................................................................................................ 2-22.6 Eagle 3017 Control Sequence and Safety Features ............................................................... 2-22.7 Physical Properties of Ethylene Oxide .................................................................................. 2-4

3 TECHNIQUES OF STERILIZATION ....................................................... 3-13.1 Guidelines For Use of Ethylene Oxide Sterilizers/Aerators .................................................... 3-13.2 Preparation of Materials ........................................................................................................ 3-23.3 Sterilizable Items .................................................................................................................. 3-23.4 Wrapping and Packaging Materials ...................................................................................... 3-33.5 Loading the Sterilizer/Aerator ................................................................................................ 3-33.6 Control Measures for Determining Efficacy of Sterilization Process ....................................... 3-33.7 Chemical Controls ................................................................................................................. 3-4

4 COMPONENT IDENTIFICATION ............................................................ 4-14.1 Main Power Supply ............................................................................................................... 4-14.2 Operating End Control ........................................................................................................... 4-24.3 Non-Operating End Control Panel .......................................................................................... 4-44.4 Door Operation ...................................................................................................................... 4-44.5 Door Status ........................................................................................................................... 4-5

5 STERILIZER CYCLES AND CYCLE VALUES ....................................... 5-15.1 Permanent Default Cycles and Cycle Values ......................................................................... 5-15.2 Changing Sterilizer Cycles and Cycle Values ........................................................................ 5-15.3 Hospital vs. Lab Mode Features ........................................................................................... 5-15.4 Hospital Mode Values ........................................................................................................... 5-25.5 Lab Mode Values .................................................................................................................. 5-2

6 OPERATING INSTRUCTIONS ................................................................ 6-16.1 Before Operating the Equipment ........................................................................................... 6-16.2 Power Unit Up ....................................................................................................................... 6-26.3 Filling Distilled Water Reservoir ............................................................................................. 6-36.4 EO Cartridge Installation ....................................................................................................... 6-46.5 Automatic Operation 130oF (54oC) Cycle Description ............................................................ 6-6

6.5.1 Sterilizing with Aeration for 130oF (54oC) Cycle ..........................................................6-116.5.2 Pausing Aeration for 130oF (54oC) Cycle ....................................................................6-136.5.3 Pausing Aeration Procedure .......................................................................................6-146.5.4 Sterilizing Without Aeration for 130oF (54oC) Cycle .....................................................6-15

6.6 Automatic Operation 100oF (38oC) Cycle Description .......................................................... 6-166.6.1 Sterilizing with Aeration for 100oF (38oC) Cycle ..........................................................6-216.6.2 Pausing Aeration for 100oF (38oC) Cycle ....................................................................6-236.6.3 Pausing Aeration Procedure .......................................................................................6-246.6.4 Sterilizing Without Aeration for 100oF (38oC) Cycle .....................................................6-25

7 OPERATION OF UNITS WITH EO DISPOSER ....................................... 7-17.1 General ................................................................................................................................. 7-17.2 Sterilizer Displays ................................................................................................................. 7-17.3 Control Boxes ....................................................................................................................... 7-1

8 DOCUMENTATION REFERENCE MATERIAL........................................ 8-1

1-1Listing of Safety Precautions Operator Manual 129353-701

LISTING OF SAFETY PRECAUTIONS 1

DANGER – ETHYLENE OXIDE (EO): TOXIC. POSSIBLE CANCER, REPRODUC-TIVE, AND EXPLOSION HAZARD:

The ethylene oxide sterilant used with this unit has toxic properties. Use care in handling. Follow theprocedures provided in Section 2 of this manual.

Employment of inexperienced, unqualified persons to work on the equipment or the installation ofunauthorized parts could cause personal injury or result in costly damage. Repairs and adjustments other thanthose described in this manual must be attempted only by an experienced technician fully acquainted with thisequipment using appropriate servicing procedures per Service and Maintenance Procedures (P129353-707),and in accordance with STERIS Safety Guidelines M1846 (P62942-091).

The chamber door(s) remains locked until completion of the programmed exhaust or aeration phase or duringpower failure. In the case of power failure, continue or abort cycle when power is restored.

In-chamber aeration must be selected whenever possible. If transfer to an aerator must be made, seeSTERIS publication M1846 (P62942-091), "After Sterilization," for aeration instructions.

During a power failure the steps outlined in Section 6 of Service and Maintenance Procedures (P129353-707)must be followed precisely to reduce the risk of possible injury. (See STERIS Publication M1846 [P62942-091].)

Prior to using or servicing this equipment, Prior to using or servicing this equipment, Prior to using or servicing this equipment, Prior to using or servicing this equipment, Prior to using or servicing this equipment, all employees must review contents of the STERIS SafetyGuidelines Ethylene Oxide (EO) Gas Sterilization Manual M1846 (P62942-001). Contact STERIS if you need acopy.

DANGER – EXPLOSION AND FIRE HAZARD:

The 100% Ethylene Oxide used in this equipment is highly flammable and presents an explosion and firehazard. Keep all sources of ignition, such as matches, lighted cigarettes, sparks, and static discharge awayfrom the sterilizer and cartridges. Never put electrical items containing batteries in load to be sterilized.

EO cartridges must be stored at a temperature less than 100oF (38oC).

Maintain only one day’s supply or a maximum of twenty-four EO cartridges (two boxes) in the immediatesterilizer area, having a minimum of ten air changes per hour.

Store additional EO cartridges in an approved flammable liquid storage compartment or cabinet whichis vented to outside exhaust system. Check the local fire protection codes for additional requirements.

Never place a leaking EO cartridge in a standard aeration cabinet.

This equipment is designed to use STERIS sterilant cartridge as the sterilizing agent.This equipment is designed to use STERIS sterilant cartridge as the sterilizing agent.This equipment is designed to use STERIS sterilant cartridge as the sterilizing agent.This equipment is designed to use STERIS sterilant cartridge as the sterilizing agent.This equipment is designed to use STERIS sterilant cartridge as the sterilizing agent.

The following is a list of the Safety Precautions which must be observed when operating or servicing this Amsco®

Eagle® 3017 100% EO Sterilizer/Aerator and handling the Envirosystems® Ethylene Oxide Sterilant cartridges.DANGER indicates personal injury or substantial property damage will result if proper precautions are not taken, whileWARNINGS indicate the potential for danger to personnel, and CAUTIONS indicate the potential for damage toequipment. These precautions are repeated (in whole or in part), where applicable, throughout the manual. It isimportant to review these Safety Precautions before operating the unit. Also read the Material Safety Data Sheetand STERIS Safety Guidelines M1846 (P62942-091) for additional information on the proper use and handling of EO.

1-2129353-701 Operator Manual Listing of Safety Precautions

DANGER – EO EXPOSURE/PERSONAL INJURY HAZARD:

EO is toxic. Avoid exposure to EO. Exposure to EO may cause serious adverse health effects. Possiblecancer and reproductive hazard. May cause irritation of the nose, throat and lungs, weakness, nausea andvomiting (immediate or delayed), chest pain and neurotoxic effect.

Avoid EO contact with the eyes. Splashes of EO may cause severe eye injury. High concentrations of vapormay cause severe eye irritation and injury.

Avoid EO contact with skin. Liquid EO may cause skin irritation, dermatitis, and blistering. There may be alatent period of several hours to the onset of these symptoms.

Do not swallow liquid EO. Ingested liquid EO is caustic and may cause severe irritation and ulceration of themouth and throat, abdominal pain, liver damage, nausea, vomiting, collapse, and coma.

WARNING – ELECTRIC SHOCK HAZARD:

Before performing any work on the sterilizer, locate the main service box supplying power to the unit. Throwthe lever to the OFF position and lockout if possible. The sterilizer is powered even with the sterilizer powerswitch OFF.

CAUTION – POSSIBLE EQUIPMENT DAMAGE:

Never use a wire brush or steel wool to clean door and chamber assembly.

To avoid possible equipment damage, only use distilled water in the sterilizer reservoir.

STATEMENT FOR IMMEDIATE TREATMENT/FIRST AID:• Inhalation. Immediately seek fresh air. If not breathing, give artificial respiration. If breathing becomes difficult,

give oxygen. Contact a physician immediately.

• Eye Contact. Immediately flush the eyes with water for a minimum of 15 minutes. Contact a physicianimmediately.

• Skin Contact. Flush the area of contact with water for a minimum of 15 minutes. Remove contaminated clothingwhile flushing. Wash the affected area with soap and water. Contact a physician immediately. Aeratecontaminated clothing and launder before reuse. Discard contaminated shoes and other leather items.

• Ingestion. Induce vomiting by giving syrup of ipecac followed by water. Repeat in 20 minutes if not effective.Contact a physician immediately.

NOTES TO PHYSICIAN:Persons exposed to ethylene oxide may develop severe and continued vomiting, requiring the use ofantiemetics given intravenously. Prolonged or high vapor concentration exposure may result in thedevelopment of pulmonary edema after a latent phase of several hours. Following skin contact, primaryirritation and blister formation may be delayed in onset. When introduced directly into the bloodstream,ethylene oxide may act as a hapten and lead to the development of anaphylactoid reactions of varyingseverity. This has been noted in a few hemodialysis and plasmapheresis patients due to desorption of ethyleneoxide from items sterilized and not properly aerated. There appears to be a close association to the presenceof IgE antibodies to Albumin/ethylene oxide conjugates.

2-1Safety Considerations Operator Manual 129353-701

2.3 Damaged orExpired Cartridges

2.1 Area EO Monitor

2.4 EO CartridgeLeaks

DANGER – EXPLOSION ANDFIRE HAZARD: Never place aleaking EO cartridge in a stan-dard aeration cabinet.

2SAFETY CONSIDERATIONS

An Ethylene Oxide (EO) monitor(s) should be located in the area of the EOsterilizer and cartridge storage area for detection and notification of any EOleaks from sterilizer, piping, the Envirogard™ system or cartridge storage area.

When notified of a leak or spill, immediately evacuate the area. The trainedemergency team must take these measures:

1. Ventilate the area by increasing local exhaust, in order to decrease EOconcentrations by dilution with air. This can be done by opening louvers ordampers.

2. If the area must be entered before high EO concentrations are reduced, thefollowing protective clothing and equipment must be used:

• EO-impermeable clothing, providing complete body coverage to preventskin contact with liquid EO or EO-containing solutions.

• Splash-proof safety goggles or face shield.

• Work shoes impermeable to EO. Leather shoes must be discarded ifcontaminated with EO.

• Butyl rubber work gloves.

• An air-supplied positive-pressure, full-facepiece respirator with a jointlabel of approval from the Mine Safety and Health Administration (MSHA)and National Institute for Occupational Safety and Health (NIOSH) for usewith ethylene oxide.

3. Any symptoms of acute exposure to EO must be treated according toaccepted medical procedures.

Cartridges that have been damaged or deformed may leak or not functionproperly in the sterilizer. These cartridges must not be used. Unused cartridges,older than the expiration date printed on the container, must not be used.

Damaged or expired cartridges must be disposed of in accordance with localhazardous disposal regulations. DO NOT RETURN ANY DAMAGED, EXPIREDOR UNUSED CARTRIDGES TO STERIS OR TO THE CARTRIDGE MANUFAC-TURER.

Any of the following would indicate an EO leak:

• EO cartridge is below normal weight.

• EO cartridge when handled is cold.

• Liquid EO or gas is leaking from EO cartridge.

• The area must be immediately evacuated.

2.2 EmergencyAction

2-2129353-701 Operator Manual Safety Considerations

• Direct contact with EO must be avoided.

• All sources of ignition (open flame, sparks, heat, cigarettes, static charge,etc.) must be kept from coming in contact with EO gas.

• Notify designated safety personnel of condition.

• Eye wash and shower facility should be immediately available in the area.

• Avoid re-entering area of EO leak until safety personnel advise the area is safeto re-enter.

• Discard any leather item that has come in contact with EO.

• Any clothing that has come in contact with EO must be laundered beforereusing.

1. Control will not allow cycle to start unless there is adequate water forhumidification in the reservoir.

2. Control will not allow cycle to start unless there is sufficient exhaust air flowat the sterilizer.

3. The door must be closed, the door lever must be latched, and the lockingmechanism must be in place before the cycle can be started.

4. The door lock remains locked throughout the entire cycle, even if power isremoved, no matter what the chamber pressure is. The chamber door cannotbe opened if the lock is engaged.

5. The entire cycle is run at negative pressure with respect to atmosphere, tominimize the possibility of EO leaking.

6. At the start of the cycle, the chamber must draw down from atmosphere(1000 mbar) to 120 mmHg (160 mbar) within 45 minutes. If not, there is eithera leak or a problem with the vacuum system. The cycle is automaticallyaborted before the cartridge is punctured.

7. The water and gas evaporator must reach 205oF (96oC) temperature within45 minutes after starting a cycle. If not, there is a problem with the heater orthe sensor. The cycle is automatically aborted before the cartridge ispunctured.

8. The chamber temperature must reach the preset value 100oF (38oC) for a lowtemperature cycle or 130oF (54oC) for a high temperature cycle within45 minutes of starting the cycle. If not, the cycle is automatically abortedbefore the cartridge is punctured.

9. The chamber will draw down (for 3 minutes) from 120 mmHg (160 mbar) tominimum 96 mmHg (128 mbar). If not, a leak is assumed and the cycle isautomatically aborted before the cartridge is punctured.

10. Water vapor is injected four times to precondition and humidify the loadbefore sterilization begins. On the first pulse, the pressure must rise at least12 mmHg (16 mbar). If not, the water injection system has failed. The cycleis automatically aborted before the cartridge is punctured.

In the HI-TEMP cycle, the control will also monitor the pressure rise on thesecond pulse. If a preset pressure rise is not met, the control senses aheavy load and adds three additional humidity pulses.

2.5 EO Leaks orSpills

2.6 Eagle 3017Control Sequence

and Safety Features

2-3Safety Considerations Operator Manual 129353-701

11. The chamber again must draw down to minimum 96 mmHg (128 mbar)within 10 minutes, or a leak is assumed, and the cycle is automaticallyaborted before the cartridge is punctured.

12. The chamber and evaporator temperatures are again checked toconfirm they are within acceptable limits. If not, the cycle is automati-cally aborted before the cartridge is punctured.

13. Prior to EO gas charge, the control checks the sensors on the puncturecylinder to ensure that the puncture needle is in the down (retracted)position. The cartridge physically cannot be punctured unless there issufficient vacuum in the chamber. The puncturing mechanism requiresthe negative pressure in the chamber acting on the cylinder piston toprovide the power to puncture the cartridge.

14. Once the cartridge is punctured, the chamber pressure must rise atleast 150 mmHg (200 mbar). If the pressure rise (after 50 seconds) isless than 37 mmHg (50 mbar), it is assumed there was no cartridgepuncture and no gas injection. The cycle is automatically aborted andthe normal gas exhaust and air wash sequence is performed before thedoor is unlocked, just in case there is any gas in the chamber.

15. If the pressure rises (after 50 seconds) less than 150 mmHg (200 mbar)when the cartridge is punctured (but more than 37 mmHg [50 mbar]),it is assumed that the cartridge is only partially punctured. The normalexhaust and air wash sequence is performed, but the chamberremains locked, and only a qualified serviceman can unlock it.

16. The chamber temperature and vacuum are continually monitoredthroughout the cycle, and in the event of any abnormality, the normalexhaust and air wash sequence is performed before the door isunlocked.

17. If the cycle is manually aborted by the operator any time during gasexposure, the normal gas exhaust, air wash, and aeration sequenceis performed before the door is unlocked.

18. The normal exhaust draws the chamber down to 96 mmHg (128 mbar).The vent valve is then opened. The pressure must rise from filtered airentering the chamber. If not, the air filter is assumed plugged, and amessage is displayed for the operator.

19. The normal air wash will continue to draw filtered room air through thechamber for 30 minutes. If aerate selected, unit will enter aerate phase.If aerate not selected, unit will signal operator that cycle is complete.

20. When aerate is selected, after cycle completion, the chamber willaerate, and will display aerate countdown time, until aeration iscomplete. If aerate is not selected, after cycle completion, thechamber will enter aeration until the operator unlatches the door.

21. The sterilizer uses a unit-dose cartridge so the amount of gas presentin the event of any malfunction is limited.

22. The printout records the normal or abnormal events of the cycle. Thisinformation is also available through the optional RDS™ (Reprocess-ing Documentation System). The RDS is a dedicated informationcollection and management system designed specifically to meet thereporting, documentation and storage needs of sterilizer processingoperations. Contact STERIS.

2-4129353-701 Operator Manual Safety Considerations

23. The operator display clearly indicates the condition of the sterilizer underboth normal and abnormal circumstances.

NOTE: The sterilizer exhaust can be attached to an Amsco® EO Disposer™(optional) to break down EO to carbon dioxide and water and thereby prevent thedischarge of EO to the atmosphere.

Boiling point

• At 101.325 KPa (760 Torr) 10.4oC (50.7oF)

• At 39.997 KPa (300 Torr) -11.0oC (12.2oF)

• At 1.333 KPa (10 Torr) -66.0oC (-86.8oF)

Freezing point -112.6oC (-170.7oF)

Vapor pressure at 20oC (68oF) 146.0KPa (21.17psia)

Water solubility Completely miscible

Vapor density (air=1) 1.52

Specific Gravity (water =1) 0.8719(100 gm = 115 mL)

See Material Safety Data Sheet (MSDS) for further information.

2.7 PhysicalProperties of

Ethylene Oxide

3-1Techniques of Sterilization Operator Manual 129353-701

Ethylene oxide (EO) gas is used to sterilize items which, because of theirsensitivity to moisture and/or heat, cannot be sterilized by steam or dryheat. The information in this section is intended as a guide to whichmaterials can be sterilized by this method and the procedures to befollowed when doing so. For in-depth training, STERIS offers a wide rangeof educational programs designed to meet the educational needs ofhospitals - contact the STERIS Education Department for details.

NOTE: Four factory preset cycles have been qualified for items typicallysterilized with ethylene oxide; however, all items must be sterilized inaccordance with item manufacturer’s recommendations.

ALL PERSONNEL OPERATING THIS EQUIPMENT MUST COMPLETEINSTRUCTION IN ALL PARAMETERS OF ETHYLENE OXIDE GASSTERILIZATION PRIOR TO USE. RESPONSIBLE SUPERVISION MUSTBE PROVIDED AND PROCEDURES FOR AREA AND PERSONNELMONITORS MUST BE DEVELOPED AND IMPLEMENTED.

1. Follow the procedures listed in this manual for proper operation andmaintenance of the equipment.

2. EO gas removal (to customer’s EO gas exhaust system):

• EO Gas Sterilizer/Aerator removes gas from sterilizer chamber andload during exhaust - air wash and aeration (if programmed).

• Envirogard™ System connects to dedicated facility non-recirculatingexhaust system and interfaces with the sterilizer control.

• EO Sterilizers must be installed in an area that has a minimum of 10room air changes per hour.

• Sterilizer EO exhaust piping must be vented directly to a non-recirculating, dedicated outside exhaust system or to an Amsco® EODisposer™ System.

• The facility non-recirculating dedicated outside exhaust system mustbe in constant operation from cycle initiation through aeration.

3. To ensure lowest possible worker exposure to EO gas, cycle withaeration must always be selected whenever possible. Although notrecommended, aerate cycle can be paused or aborted and load movedto a separate aerator, or biological monitors can be removed. Aeratepause or abort is described in a later section.

4..... Avoid direct contact with sterilant or inhalation of its vapors.

• Monitoring should always be done, even when using in chamberaeration.

5. Removal of goods prior to full aeration.

• Although not recommended, when the sterilizing phase is completeand in chamber aeration phase must be omitted, follow the procedureoutlined in the Operating Instructions. Pausing aeration procedureincludes opening the door 2" (51 mm), and waiting at least 15 minutesbefore removing any part of the load from the sterilizer. See Section 6,Pausing Aeration Procedure.

DANGER – EXPLOSION ANDFIRE HAZARD: This equip-ment is designed to useSTERIS sterilant cartridge asthe sterilizing agent. Refer toSection 8 of this manual forthe recommended orderinginformation.

3.1 Guidelines ForUse of Ethylene

Oxide Sterilizers/Aerators

3TECHNIQUES OF STERILIZATION

DANGER – ETHYLENE OX-IDE (EO): TOXIC. POSSIBLECANCER, REPRODUCTIVE,AND EXPLOSION HAZARD:The chamber door(s) remainslocked until completion ofthe programmed exhaust oraeration phase or duringpower failure. In the case ofpower failure, continue orabort cycle when power isrestored.

3-2129353-701 Operaor Manual Techniques of Sterilization

DANGER – ETHYLENE OX-IDE (EO): TOXIC. POSSIBLECANCER, REPRODUCTIVE,AND EXPLOSION HAZARD:The ethylene oxide sterilantused with this unit has toxicproperties. Use care in han-dling. Follow the proceduresprovided in Section 2 of thismanual.

• Wear personal protective equipment including butyl rubber gloves ifprocessed items must be directly handled prior to aeration (use basketsand/or transfer cart).

• Transfer goods to a filtered, heated forced air aeration cabinet for aeration.

• Always pull the sterilized load so that the flow of air over the load is awayfrom the operator.

3.2 Preparation ofMaterials

Cleaning. Items to be sterilized should be thoroughly cleaned and, whereapplicable, disassembled for sterilization, as debris such as blood, mucus, oilor other foreign matter interferes with the sterilization process by acting as abarrier to the sterilizing agent. Cleaning reduces the bioburden and enhancesthe sterilization efficiency.

Saline solution must not be used for cleaning. Ethylene oxide will react withresidual saline during sterilization processing, causing ethylene chlorohydrin toform.

Ethylene oxide sterilization must not be used as an initial decontaminationprocess without cleaning the items first. Items to be decontaminated maycontain soil, protein, crystals, or solutions that could render the EO sterilizationor aeration process ineffective and that could potentially harm unawarepersonnel.

For additional information about preparing materials, see Preparing Instru-ments, Utensils, and Textiles for Sterilization and Wet Pack Problem Solving(M1844). Contact your STERIS if you do not have this manual.

1. Telescopic Instruments: bronchoscopes, cystoscopes, endoscopes, oph-thalmoscopes, proctoscopes, etc.

2. Plastic Goods: catheters, nebulizers, syringes, gloves, etc.

3. Rubber Goods: tubing, surgical gloves, catheters, etc.

4. Instruments and Equipment: cautery sets, eye knives, lamps, scalpelblades, specula, etc.

5. Miscellaneous: dilators, electric cords, hair clippers, etc.

NOTE: Items listed above represent general categories. Items should always besterilized in accordance with manufacturer's specific recommendations.

3.3 SterilizableItems

3-3Techniques of Sterilization Operator Manual 129353-701

The following table lists acceptable and unacceptable wrapping and packagingmaterials for ethylene oxide gas sterilization, as recommended by the Associa-tion for the Advancement of Medical Instrumentation (AAMI).

Acceptable UnacceptablePolyethylene plastic bags Packages that are made(designed for use as a sterile package) entirely of any of the

following materials:Peel pouches:

Spun-bonded olefin (Tyvek*) Foilspolyethylene-polyester Cellophanelaminate (preferred for EO) Polyvinyl Chloride (PVC)

PolypropylenePaper/polyethylene-polyester laminate Polyesters (Mylar*)

Polyamides (Nylon)Polyvinylidene Chloride

Paper/polypropylene-polyester laminate e.g., (Saran WrapTM)**

Wraps:Woven textileNon-woven textilePaper, coated and uncoated

Rigid sterilization containers(designed to be used in EO systems)/plastic trays with paper or Tyvek* lids

**A registered trademark of E. I. DuPont de Nemours & Co.

**A trademark of the Dow Chemical Company.

NOTE: All packaging materials used for EO sterilization must be gas permeableand allow for proper aeration. Do not use packaging material not specificallywarranted by the manufacturer for use in EO sterilization.

Materials can be loaded into sterilizer using one or two baskets.

1. Arrange all packages in load so that gas mixture can circulate freely (seeFig. 3-1).

2. Place paper/plastic peel pouch type packages on edge with the plastic sideof one facing the paper side of the next.

3. Do not allow packages to touch chamber walls.

4. Provide minimum of 1/4 to 1/2" (6 to 13 mm) space between the chamberceiling and the topmost packages of the load to allow for circulation.

Biological Monitors. The best way to determine the efficacy of the sterilizingprocess is to use a biological monitor.

A live spore test using B. atrophaeus is the most reliable form of biologicalmonitoring. Products are available that utilize known populations of a knownresistance so that survival time and kill time can be demonstrated. Gassterilizers should be tested every cycle

A STERIS representative will gladly review the available products and assistyou in selecting monitors best suited to your application.

3.4 Wrapping andPackaging Materials

3.5 Loading theSterilizer/Aerator

3.6 ControlMeasures forDetermining

Efficacy ofSterilization Process

3-4129353-701 Operaor Manual Techniques of Sterilization

Figure 3-1. Arrange Packages for Maximum Efficacy of Sterilization

Chemical Indicator - When placed in the center of pack/package indicates thatpackage was exposed to ethylene oxide gas and humidity.

The chemical indicator is one of a series of sterilization process controls usedin an effective sterility assurance program. Chemical indicators are through putindicators which verify the presence of one or more critical parameters of thesterilization process. Chemical indicators do not assure sterility of the productor load.

3.7 ChemicalControls

4-1Component Identification Operator Manual 129353-701

Become familiar with all control locations and functions before operatingthe sterilizer/aerator (see Figs. 4-1 and 4-2).

The MAIN POWER SUPPLY Switch is located behind the left side cabinetpanel towards the rear of the sterilizer. It supplies power to the control.Remove left side panel by removing three screws located at bottom edgeof side panel and lift it up. Turn ON MAIN POWER SUPPLY Switch. Reinstallside panel onto sterilizer with mounting screws. Under normal operatingconditions, this switch is always left in the ON position.

Figure 4-2. Control Component Location (Operating End)

Figure 4-1. Main Power Supply Switch

4COMPONENT IDENTIFICATION

4.1 Main PowerSupply

4-2129353-701 Operator Manual Component Identification

STATUS

STATUS

Control Power Supply Switch

The CONTROL POWER SUPPLY Switch is located within the control panelbehind printer door. This switch places the sterilizer in either an ON or STANDBYmode, but does not disconnect power to control.

Printer

The impact printer records all cycle data and transition points on 2-1/4 inch(57 mm) wide single ply paper. This paper is on a roll inside the printer and willhave to be changed periodically (based on sterilizer usage). See “ChangePrinter Paper Roll,” Section 5 of Service and Maintenance Procedures(P129353-707), for paper changing procedure. Information for ordering newpaper can be found in the Illustrated Parts Breakdown Manual (P129353-704).

• Print -- Press PRINT touch pad (see Fig. 4-3) to obtain a printout of cyclephase, time of day, chamber temperature and chamber pressure (when unitis in cycle) or obtain a printout of EO gas vaporizer temperature (when unit isout of cycle).

• Paper Advance -- Press PAPER ADVANCE touch pad (see Fig. 4-3) toadvance the printer paper.

NOTE: Service mode selection provides printing data from top to bottom of tapeor from bottom to top of tape. Sterilizer is shipped to have printing data frombottom to top of page.

Operating End Control Panel

See Figure 4-4. The operating end control panel is used to start cycles, setcycles and cycle values, obtain status and final printouts and abort cycles.

• Display Window

See Figure 4-5. Cycle status and control messages are shown on a 2 line x 20character vacuum fluorescent display.

When not in cycle and the door is latched, the display alternately showsavailable cycle selections:

1 = HI_TEMP 3 = LO_TEMP2 = HI_TEMP 4 = LO_TEMP

and

TIME T = XXX.XFHH:MM:SS (A/P) P = XXXmm

The display will also show cycle status (cycle in progress) and fault messages(alarms or abnormal conditions).

Figure 4-3. Print Touch Pads

Figure 4-4 Operating EndControl (Printer Door Open)

4.2 Operating EndControl

Figure 4-5 Display Window


Figure 4-8. Reset Function

Figure 4-6. Cycle SelectorTouch Pads

Figure 4-7. Values TouchPads

• Cycle Selector Touch Pads

See Figure 4-6. Four touch pads, numbered 1 through 4, are located below thedisplay window. These touch pads are used to select the cycle to be run. Thetype of cycle that can be selected by the touch pad is shown on the display,next to the corresponding number of the pad. For example, 1=HI_TEMP (on thedisplay) means that by pressing the #1 touch pad a HI_TEMP cycle can beselected.

Pressing a touch pad once selects the cycle and displays the cycle’s operatingvalues. Pressing the same touch pad twice, within five seconds, selects andstarts the cycle.

• Values Touch Pads

See Figure 4-7. These touch pads are located on the operating end of sterilizeronly and accessible when hinged control cover is in open position. The valuestouch pads are used for changing the operating values used in cycles, changingthe cycles displayed on the main cycle selection menu, and for changing theoperating settings of the sterilizer. Changing sterilizer cycle parameters byusing the values touch pads is discussed in Chapter 5 of this manual.

• Reset Function

See Figure 4-8. The reset touch pad is used to abort a cycle.

NOTE: The sterilizer control will react to the Reset button based on where it isin a cycle. See Table 4-1.

Phase whenRESET

Initial Vacuum

Preheat

Second Vacuum

Condition

Third Vacuum

Charge

Sterilize

Exhaust

Air Wash

Aerate

Result

Cycle aborts to chamber air break, then display returns to cycle selection menu.


Cycle aborts to chamber air break, then display returns to cycle selection menu.Cycle aborts to chamber air break, then display returns to cycle selection menu.


Cycle advances to exhaust phase, then completes (sterilize only cycle) or continues withaeration (sterilize with aeration cycles).

Cycle advances to exhaust phase, then completes (sterilize only cycle) or continues withaeration (sterilize with aeration cycles).

Exhaust phase continues as set, then completes (sterilize only cycle) or continues withaeration (sterilize with aeration cycles).

Air Wash phase completes, then completes (sterilize only cycle) or continues with aeration(sterilize with aeration cycles).

Aeration phase continues as set at cycle initiation. Aeration may be aborted (see Section 6).

Table 4-1. Cycle Abort

4-4129353-701 Operator Manual Component Identification

NOTE: If you push the wrong cycle selector touch pad when starting a cycle,proceed as follows (Note, however, you must press the pad twice before a cycleis actually initiated):

1. Press RESET touch pad to abort cycle. Control proceeds to abort cycle asdescribed in Table 4-1.

2. Wait until door status and cycle selection menu is displayed.

3. Press touch pad for correct cycle. Printer records selected cycle andproceeds through the correct cycle.

(Double Door Models Only, see Fig. 4-9.)

The non-operating end control panel features display window, four cycleselector touch pads, and RESET touch pad. Display window concurrentlyshows the same message as shown in display window on the operating end ofthe sterilizer/aerator.

••••• Cycles can be started or reset using the four cycle selector touch pads andthe RESET touch pad.

••••• Cycle status and control messages are concurrently shown on a 2 line x 20line character display.

4.4 Door Operation

4.3 Non-OperatingEnd Control Panel

Figure 4-10. Operating End Door Handle

Figure 4-9. Non-OperatingEnd Control (Double Door

Units Only)

STATUS

CYCLE

1 2 3 4 RESET

STATUS

CYCLE

PRINTER

VALUES

1 2 3 4 RESET

PRINT PAPERADVANCE

CHANGEVALUES

CURSOR VALUESAVE

VALUES

See Figures 4-9 and 4-10.

A handle operates the door for latching and unlatching. Door can be swung openor closed when unlatched.

NOTE: The operator rotates the door handle to either "latch" or "unlatch" thedoor. When the door is latched, it may not necessarily be locked. The door islocked, or unlocked, by the control at appropriate times during automaticoperation.

••••• To open door from latched position—Rotate handle counterclockwise(operating end) or clockwise (non-operating end) as far as it will go and swingdoor open by hand.


STATUS

STATUS

STATUS

STATUS

••••• To close and latch door from open position - Swing door closed androtate handle clockwise (operating end) or counterclockwise (non-operating end) to vertical position.

Note that the door cannot be unlatched if the unit is in cycle. The door canbe opened only when the unit is not in cycle or on completion of cycle.

Under normal conditions the unit’s door is left unlatched but closed whennot in operation. At this time the display will be:

DOOR T = XXX.XFUNLOCKED P = XXXmm

alternating with. . .

1 = HI_TEMP 3=LO_TEMP2 = HI_TEMP 4=LO_TEMP

These messages are displayed anytime the door switch is not activated.The printer also records the following message anytime the door switchceases to be activated:

UNLATCHED*DOOR (time of day)

Whenever the door is latched and switch is activated the display messagechanges to the following:

TIME T = XXX.XFHH:MM:SS(A/P) P = XXXmm


1 = HI_TEMP 3=LO_TEMP2 = HI_TEMP 4=LO_TEMP

There is no printout to indicate when the door switch has been activated.Once the door switch has been activated, and the display changes, ensurethat the door handle remains in the vertical position.

4.5 Door Status

5-1Sterilizer Cycles and Cycle Values Operator Manual 129353-701

The Amsco® Eagle® 3017 100% EO Sterilizer/Aerator has been pre-programmed with default sterilize/aerate cycles. These cycles have beenestablished by STERIS research to be the most effective sterilizationcycles for this equipment and for many recommended sterilizable items.ALTHOUGH HI_TEMP AND LO_TEMP CYCLES AND CYCLE VALUESCAN BE ADJUSTED AND CHANGED BY THE USER, DOING SO IS NOTRECOMMENDED. IF THESE VALUES ARE CHANGED, THE OPERA-TOR MUST ENSURE EFFICACY OF THE MODIFIED CYCLE FOREVERY ITEM BEING PROCESSED. Aeration times may be adjustedaccording to medical device manufacturer’s written processing instruc-tions. Table 5-1 lists sterilizer/aerator default cycle values.

Table 5-1. Default Cycle Values

Cycle Sterilize Sterilization AerationName Time Temperature Time

1=HI_TEMP 1 hour* 130F*** 12 hours

2=HI_TEMP 1 hour* 130F*** None

3=LO_TEMP 4-1/2 hours** 100F*** 36 hours

4=LO_TEMP 4-1/2 hours** 100F*** None

* Minimum 1 hour** Minimum 4-1/2 hours

*** Range of adjustment: Minimum 100oF (38oC) - maximum 131oF(55oC)

NOTE: Only the time of day and date can be changed with unlimited access.All other values (Hospital Mode and Lab Mode) listed below can be securedagainst change by unauthorized personnel by use of access code function.Refer to Service and Maintenance Procedures (P129353-707), Section 4,for details of changing values and using access code function.

STERIS does not recommend changing default cycle values. If thesevalues are changed, the operator must ensure efficacy of the modifiedcycle for every item being sterilized.

The sterilizer is configured to operate in a Hospital Mode. This mode limitsthe adjustment that can be made by the operator. The unit can beconfigured to operate in the Laboratory Mode as described next.

5.2 Changing Steril-izer Cycles and

Cycle Values

5STERILIZER CYCLES AND CYCLE VALUES

5.1 Permanent De-fault Cycles and

Cycle Values

5.3 Hospital vs. LabMode Features

5-2129353-701 Operator Manual Sterilizer Cycles and Cycle Values

The following Hospital Mode values are operator adjustable:

• Cycle print format - normal or condensed (factory set normal).

• Time units - AM/PM or 24 hour (factory set AM/PM).

• Date format - M/D/Y, Y/M/D or D/M/Y (factory set M/D/Y).

• Access code - OFF/ON (factory set OFF). This allows supervisor lockout ofcycle changes.

• Intermittent complete tone - ON/OFF (factory set ON).

• After power failure - Resume /Hold (factory set resume).

• If EO monitor alarms - Abort/Hold (factory set abort).

• Language selection - OFF/ON (factory set OFF).

• Sterilizer number - 00 to 99, AA to ZZ, or a dash (-) or a blank (■)(factory set 00).

Refer to Service and Maintenance Procedures (P129353-707), Section 4, fordetails of changing values.

The sterilizer can be programmed to operate in the Lab Mode but requires atrained technician to make a service adjustment.

The Lab Mode values are the same as in the Hospital Mode but there are severaladditional values available to program the cycles and cycle values to meetspecial cycle parameters for various products.

STERIS does not recommend changing default cycles and cycle values.When changes are made to any of these cycles and cycle values, theoperator must ensure efficacy of the modified cycle for every item beingprocessed.

Refer to Service and Maintenance Procedures (P129353-707), Section 4, fordetails of changing values.

Hospital ModeStart-Up Printout

Laboratory ModeStart-Up Printout

5.5 Lab ModeValues

5.4 Hospital ModeValues

6-1Operating Instructions Operator Manual 129353-701

6OPERATING INSTRUCTIONS

DANGER – ETHYLENE OXIDE(EO): TOXIC. POSSIBLE CAN-CER, REPRODUCTIVE, AND EX-PLOSION HAZARD: The ethyl-ene oxide sterilant used withthis unit has toxic properties.Use care in handling. Followthe procedures provided in Sec-tion 2 of this manual.

DANGER – EXPLOSION ANDFIRE HAZARD: Never place aleaking EO cartridge in a stan-dard aeration cabinet.

DANGER – EO EXPOSURE /PERSONAL INJURY HAZARD:

•EO is toxic. Avoid exposure toEO. Exposure to EO may causeserious adverse health effects.Possible cancer and reproduc-tive hazard. May cause irritationof the nose, throat, and lungs,weakness, nausea, and vomiting(immediate or delayed), chestpain, and neurotoxic effect.

•Avoid EO contact with the eyes.Splashes of EO may cause se-vere eye injury. High concentra-tions of vapor may cause severeeye irritation and injury.

•Avoid EO contact with skin. Liq-uid EO may cause skin irritation,dermatitis, and blistering. Theremay be a latent period of severalhours to the onset of these symp-toms.

•Do not swallow liquid EO. In-gested liquid EO is caustic andmay cause severe irritation andulceration of the mouth andthroat, abdominal pain, liver dam-age, nausea, vomiting, collapse,and coma.

6.1 Before Operatingthe Equipment

USE CARE IN HANDLING:

• AVOID SPRAYING STERILANT ON EYES, HANDS, FACE OR OTHERSKIN AREAS. IF CONTACT IS MADE, PROMPTLY WASH AFFECTEDAREAS WITH WATER. GET MEDICAL ATTENTION AT ONCE IFSTERILANT HAS CONTACTED EYES.

• IF CLOTHING IS SPRAYED WITH STERILANT, REMOVE AND WASHTHE AFFECTED CLOTHING BEFORE REUSE. LEATHER ITEMSMUST BE DISCARDED.

• AVOID BREATHING ETHYLENE OXIDE VAPORS. EXPOSURE TOEO GAS MAY CAUSE SERIOUS AND ADVERSE HEALTH EFFECTS.IF A SUFFICIENT QUANTITY IS INHALED, THESE VAPORS CANCAUSE HEADACHE AND NAUSEA. IF THESE SYMPTOMS AREEXPERIENCED, SEEK FRESH AIR. LIE DOWN UNTIL SYMPTOMSDISAPPEAR. DO NOT USE STIMULANTS. SEEK MEDICAL ATTEN-TION.

• NFPA 30 ALLOWS UP TO 10 GALLONS STORAGE BUT STERISRECOMMENDS NO MORE THAN TWO CASES (24 EO CARTRIDGES)IN THE IMMEDIATE STERILIZER AREA. AREA IN WHICH ETHYL-ENE OXIDE CANISTERS ARE STORED AND USED MUST HAVEROOM VENTILATION PROVIDING A MINIMUM OF 10 AIR CHANGESPER HOUR AND BE MAINTAINED AT A TEMPERATURE LESS THAN100oF (38oC).

• IF THERE IS AN INDICATION THAT AN EO CARTRIDGE IS LEAK-ING, AS A MINIMUM WEAR A RESPIRATOR AND BUTYL GLOVES,AND IMMEDIATELY EVACUATE THE AREA.

• CARTRIDGES THAT HAVE BEEN DAMAGED OR DEFORMED MAYLEAK OR NOT FUNCTION PROPERLY IN THE STERILIZER. THESECARTRIDGES MUST NOT BE USED. UNUSED CARTRIDGES, OLDERTHAN THE EXPIRATION DATE PRINTED ON THE CONTAINER,MUST NOT BE USED.

• DAMAGED OR EXPIRED CARTRIDGES MUST BE DISPOSED OF INACCORDANCE WITH LOCAL HAZARDOUS DISPOSAL REGULA-TIONS. DO NOT RETURN ANY DAMAGED, EXPIRED, OR UN-USED CARTRIDGES TO STERIS OR TO THE CARTRIDGE MANU-FACTURER.

6-2129353-701 Operator Manual Operating Instructions

CAUTION – POSSIBLEEQUIPMENT DAMAGE: Toavoid possible equipmentdamage, only use distilledwater in the sterilizer reser-voir.

1. The MAIN POWER SUPPLY Switch located behind left side cabinet paneltoward rear of sterilizer. Remove left side panel by removing three screwslocated at bottom edge of side panel and lift it up. Turn ON MAIN POWERSUPPLY Switch. Reinstall side panel onto sterilizer with mounting screws.This is necessary only on initial startup. The MAIN POWER SUPPLY Switchis always left ON unless being serviced.

2. Open printer door and position CONTROL POWER Switch to ON. The printerrecords the time and date when the power is turned on.

IMPORTANT: Check the water level in reservoir (located below the printer). Ifwater level is low, fill reservoir with distilled water following instructions given inSection 6.3 of this manual. Sterilizer will not operate unless sufficient water isin the reservoir.

IMPORTANT: Keep sterilizer door(s) in closed or latched position to preventsterilizer chamber from overheating when a cycle is started.

NOTE: Control will check for abnormalities and if any are discovered, will soundan alarm and display message accordingly. See Service and MaintenanceProcedures (P129353-707), Section 6 (Troubleshooting), for details.

3. Check for correct time of day by observing display window time and datewhen sterilizer is turned on. To change either, consult Section 5.2, ChangingSterilizer Cycles and Cycle Values, of this manual.

4. Check paper roll. A colored warning stripe will appear on the edge of thepaper when the roll is near its end. See Section 5 of Service and MaintenanceProcedures (P129353-707) if paper roll needs to be replaced.

5. Review Troubleshooting, Section 6, of Service and Maintenance Procedures(P129353-707) to identify the cause of any abnormal condition during asterilization cycle.

6. If sterilizer is a double door model, become familiar with double dooroperating procedures. The Non-Operating End Control in terms of cycleinitiation and abort is essentially identical to Operating End Control. Theoperating end control has the ON/OFF switch and printer, which are not onthe non-operating end of the unit.

NOTE: When used as a “pass through” sterilizer, the sterilizer must be installedwith the printer located on the unload side.

6.2 Power Unit Up


To add distilled water to reservoir, proceed as follows:

1. Open control access door (refer to Fig. 6-1).

2. Slide water reservoir forward until it stops.

3. Remove plastic cap at top front of reservoir.

4. Add distilled water into reservoir. Capacity is approximately one quart.Do not overfill reservoir.

NOTE: A full reservoir provides humidity for approximately 25 cycles.

5. Replace the plastic cap onto reservoir.

6. Slide water reservoir back into operating position until it stops.

6.3 Filling DistilledWater Reservoir

Figure 6-1. Filling Distilled Water Reservoir

CAUTION – POSSIBLEEQUIPMENT DAMAGE: Toavoid possible equipmentdamage, only use distilledwater in the sterilizer reser-voir.


Figure 6-2. EO CartridgeReorder No. PB013 (Case of 12 Cartridges)

6.4 EO CartridgeInstallation

DANGER – EXPLOSION ANDFIRE HAZARD: The 100% eth-ylene oxide used in thisequipment is highly flam-mable and presents an ex-plosion and fire hazard. Keepall sources of ignition, suchas matches, lighted ciga-rettes, sparks, and static dis-charge away from sterilizerand cartridges. Never putelectrical items containingbatteries in load to be steril-ized.

The EO cartridge (Fig. 6-2) is to be installed into the sterilizer chamber recesslocated inside the chamber at the front left side. See Figure 6-4.

IMPORTANT: See Figure 6-3. Prior to installing EO cartridge, inspect EOcartridge recess to assure that puncture pin mechanism is fully retracted.If the puncture pin mechanism is visible - STOP. Do not try to insert EOcartridge. Turn off sterilizer power supply and call a qualified service technician.

Seeing the puncture pin indicates a failure in the unit and the sterilizer must notbe operated until it is repaired.

Insert the cartridge into the cartridge holder (see Fig. 6-5) with the two arrowspointing down (see Fig. 6-6). The cartridge should be at a slight angle (seeFig. 6-6). Push downward and inward until it is held securely in place (seeFig. 6-7) by the cartridge holder and the cartridge retainer.

IMPORTANT: Ensure the cartridge is fully seated. Failure to seat the cartridgecompletely may cause an incomplete cartridge puncture.

IMPORTANT NOTE: Cartridges that have been damaged or deformed may leakor not function properly in the sterilizer. These cartridges must not be used.Unused cartridges, older than the expiration date printed on the container, mustnot be used.

Damaged or expired cartridges must be disposed of in accordance with localhazardous disposal regulations. DO NOT RETURN ANY DAMAGED, EXPIREDOR UNUSED CARTRIDGES TO STERIS OR TO THE CARTRIDGE MANU-FACTURER.


Figure 6-7. Cartridge in PlaceNOTE: Ensure Cartridge is

Fully Seated.

Figure 6-6.Cartridge Insertion

Figure 6-5.Chamber Recess

Figure 6-3. Puncture Pin Figure 6-4. EO Cartridge Chamber Recess

Cartridge Retainer


STATUS

STATUS

STATUS

STATUS

STATUS

DANGER – ETHYLENE OX-IDE (EO): TOXIC. POSSIBLECANCER, REPRODUCTIVE,AND EXPLOSION HAZARD:

•Prior to using or servicingthis equipment, all employ-ees must review contents ofthe STERIS Safety GuidelinesEthylene Oxide (EO) GasSterilization Manual M1846(P62942-001). Contact STERISif you need a copy.

•The ethylene oxide sterilantused with this unit has toxicproperties. Use care in han-dling. Follow the proceduresprovided in Section 2 of thismanual.

•The chamber door(s) remainslocked until completion of theprogrammed exhaust or aera-tion phase or during powerfailure. In the case of powerfailure, continue or abort cyclewhen power is restored.

6.5 AutomaticOperation 130oF

(54oC) CycleDescription

NOTE: Minimum recommended aeration time at 130oF is 12 hours, unlessotherwise notified by the medical device manufacturer’s written processinginstructions.

1. Follow instructions in Safety Guidelines for Ethylene Oxide (EO) GasSterilizers, M1846 (P62492-091), and Section 6.1, Before Operating theEquipment.

Once CONTROL POWER switch is turned ON, chamber begins to heat.

While the chamber is heating, the operator can install EO cartridge (seeSection 6.4, EO Cartridge Installation), load the sterilizer (refer to Section 3),then close and latch the door(s).

2. Display shows door status, such as:

When door is unlatched, display will read:

DOOR T=100.6FUNLOCKED P=729mm


1=HI_TEMP 3=LO_TEMP2=HI_TEMP 4=LO_TEMP

When door is latched, display will read:

TIME T=100.6FHH:MM:SS (A/P) P=729mm



3. After door is closed and latched, press and hold cycle #1 touch pad. Valuesfor the cycle are displayed. If values are acceptable, release touch pad andpress again to initiate the cycle.

Printer provides printout identifying cycle type.

Display will show:

DID YOU INSTALL GASCARTRIDGE? 1=YES


Figure 6-8. Hi-Temp 130oF Cycle - Typical Printout

NOTES:

1. Cycle data printing is from bottom of tape to top of tape.

2. Printout from a Hi-Temp cycle with a heavy load may be longer due toadditional humidification pulses.

Printout Key:C = ConditioningV = VacuumH = HumidifyP = PunctureS = SterilizeE = ExhaustA = Air wash and aerationZ = Complete


STATUS

STATUS

Press #1 touch pad if an EO cartridge has been installed in the EO cartridgechamber recess. Control will proceed to Step 4.

If an EO cartridge has not been installed in the EO cartridge chamber recess,open sterilizer door, remove load, install EO cartridge (See Section 6.4, EOCartridge Installation), then load the sterilizer, and close and latch the sterilizerdoor. Refer back to Step 3 to continue.

4. Sterilizer enters Conditioning phase. Display shows:

CONDITION T=100.6FP=729mm

During this phase, the chamber is evacuated to 120 mmHg (160 mBAR).

NOTE: Printer provides printout data at all major cycle transition points.

5. Once the required vacuum level is reached, sterilizer enters the ChamberHeat phase. Display message is “Condition.”

During this phase, the chamber temperature is checked to ensure it is atproper operating temperature (130oF - 54oC).

6. Once the chamber is at proper temperature, sterilizer enters Vaporizer Heatphase. Display message is “Condition.”

During this phase, the vaporizer temperature is checked to ensure it is atproper operating temperature (205oF - 96oC).

7. Once the vaporizer is at proper temperature, sterilizer enters Vent Checkphase. Display message is “Condition.”

During this phase, the vent filter is checked to ensure that it is not plugged.Control opens vent valve for fixed time and checks for proper amount of ventpressure rise.

8. If the vent filter is not plugged, the printer records “Vent Pressure Rise” valueand chamber is evacuated to 120 mmHg (160 mBAR) then vacuum continuesfor three minutes. Display message is “Condition.”

9. After the three minute drawdown, sterilizer enters the Humidify phase.Display message changes to the following:

HUMIDIFY T=131.6FP= 81mm


STATUS

STATUS

STATUS

STATUS

STATUS

10. The humidify phase consists of four humidity pulses to humidify the loadand the chamber. Each pulse phase is as follows:


• One minute humidity injection, then:

HUMIDIFY T=128.6F 5:00 P=135mm

• Five (5) minute humidity hold, then:

HUMIDIFY T=130.6FP=135mm

• Evacuation to minimum 120 mmHg (160 mBar) and continues evacu-ation for three more minutes.

11. Once the four humidify phases are complete, sterilizer enters anotherVacuum phase. Display message is “Humidify.”

NOTE: On the Hi-Temp cycle, if after the second humidity injection, thechamber pressure does not rise above a preset value, the control senses aheavy load and three additional humidity pulses will be added.

During this phase, the chamber is evacuated 120 mmHg (160 mBAR) andcontinues evacuation for three more minutes.

12. Once the evacuation is complete, the sterilizer enters the Vacuum Testphase. Display message may momentarily display “Vac Test.”

During this phase, the chamber vacuum level is checked to ensure it is atproper vacuum minimum level of 96 mmHg (128 mBAR) and that no leaksare present.

13. Once the vac test is complete, the sterilizer enters the Charge phase. Thecartridge is punctured and EO gas enters the chamber. Display messagechanges to the following:

CHARGE T=129.6FP= 83mm


GAS IN T=129.6FCHAMBER P= 83mm


STATUS

STATUS

STATUS

Figure 6-9. 130oF Cycle Graph

VentCheck

Draw

Down

Cham

ber

Heat

Approx.96 MMHg

O ps

ig

If for any reason, the Door is not opened when the Tone sounds to signal cyclecompletion, the Aeration Phase will continue until the Door is opened.

The humidify phase may be extended by three (3) more pulses, depending on size of load.

ChargeHumidify Sterilize ExhaustAir

WashAeratePhase

ToneTone(Sterilize Only)

***

**

**

14. Once chamber is fully charged with gas, unit enters Sterilize phase.Display message changes to the following:

NOTE: Sterilizer timer starts 50 seconds after EO cartridge is punctured.

STERILIZE T=129.7F 60:00 P=443mm


GAS IN T=129.7FCHAMBER P=443mm

Remaining sterilize time is shown in minutes and seconds. Sterilize phaseis factory set for one hour. Printer records beginning and ending times ofsterilize phase; and prints phase status every 15 minutes (factory set)during the phase.

Sterilizer is factory set so that if chamber temperature drops more than 5oF(3oC) below set sterilizer temperature, the timer stops. If the set temperatureis reattained, sterilizer will resume counting down remaining sterilize time.

15. Once sterilize phase has timed out, sterilizer enters Exhaust (Post Vac)phase. Display shows:

EXHAUST T=130.6FP=440mm


STATUS

STATUS

STATUS

STATUS

STATUS




16. Once the required vacuum level is reached, sterilizer enters the Air Washphase. Display message changes to the following:

AIR WASH T=129.7F 30:00 P= 96mm



During this phase, the chamber air vent valve is opened and room air ispulled through the vaporizer (where it is heated) and through the chamberto the EO exhaust for 30 minutes. Vacuum level in the chamber during thisphase is not as deep as in the prevac phase. Time counts down from 30:00minutes to 0:00.

At the end of exhaust, the cycle will either continue with aeration (if aerationwas selected) or go to complete (sterilize only cycle). For operation withaeration, continue with the following. For sterilize only (without aeration),proceed to Section 6.5.4.

In order to further reduce potential worker exposure to EO, cycle WITHaeration MUST always be selected whenever possible.

Following air wash, sterilizer enters Aeration phase. Display message changesto the following:

AERATE T=130.6F12:00:00 P=672mm


PRESS #1 TO PAUSEGAS IN CHAMBER

6.5.1 Sterilizing withAeration for 130oF (54oC)

Cycle


STATUS

STATUS

STATUS

During this phase, air is pulled through the vaporizer (where it is heated) to theEO exhaust for 12 hours. Time counts down from 12:00:00 to 0:00.

The printer records beginning and ending times of aeration phase and printsphase status every 60 minutes (factory set) during the phase.

Sterilizer is factory set so that if chamber temperature drops more than 5°F (3°C)below set sterilizer temperature, the timer stops. If the set temperature isreattained, sterilizer will resume counting down remaining aeration time.

At this time, although not recommended, pressing the #1 touch pad causesthe aeration phase to pause. After following the Pausing Aeration procedurelisted in Section 6.5.2, the operator may move all or part of the load to a separateaeration unit, or remove biological indicators to determine efficacy of thesterilization phase. If the entire load is moved to a separate aeration unit, theaeration phase of the sterilizer cycle can be aborted. Otherwise, the aerationphase of the sterilizer cycle is to be resumed and completed.

NOTE: Minimum recommended aeration time at 130°F (54°C) is 12 hours, unlessotherwise notified by the medical device manufacturer’s written processinginstructions.

DO NOT open the sterilizer door before full aeration is completed withoutfollowing the “Pausing Aeration” procedure listed in Section 6.5.2.

When the set aeration time has been completed, the display shows:

COMPLETE T= 130.1FOPEN DOOR P=740mm

Open door and remove load.

NOTE: At completion of any cycle and sterilizer door is opened, the control willautomatically maintain chamber at previously selected cycle temperature if theCONTROL POWER Switch is left in the ON position.

Remove the aerated empty EO cartridge and dispose of with non-incineratedwaste.

If the door is not opened within one minute, standard aeration is resumed andthe display will show:

COMPLETE T=130.1FP=672mm

alternating with:

PRESS 1 TO T =130.1FOPEN DOOR P=672mm

To remove load, press the #1 touch pad and the display will change to:


STATUS

STATUS

STATUS

STATUS

STATUS

STATUS

STATUS

6.5.2 Pausing Aeration for130oF (54oC) Cycle

AIR BREAK T=130.1F 0:45 P=672mm

alternating with...

WAIT TOOPEN DOOR

After the programmed 45-second air break, the control unlocks the door. Thedisplay now shows:

COMPLETE T=130.FOPEN DOOR P=740mm


TO PREVENT INADVERTENT EXPOSURE, PERSONNEL MONITORING ISREQUIRED WHEN PAUSING DURING THE AERATION PHASE.

Although not recommended, if it is necessary to interrupt the aeration phase,press the #1 touch pad. The display will change from:

AERATE T=130.1F12:00:00 P=672mm

alternating with...


to:

AIR BREAK T=130.1F0:45 P=672mm

alternating with...

WAIT TOOPEN DOOR

DANGER – ETHYLENE OX-IDE (EO): TOXIC. POSSIBLECANCER, REPRODUCTIVE,AND EXPLOSION HAZARD:In-chamber aeration must beselected whenever possible.If transfer of load to an aera-tor must be made, seeSTERIS publication M1846(P62942-091), "After Steriliza-tion," for aeration instruc-tions.


STATUS

STATUS

STATUS

STATUS

STATUS


OPEN DOOR T=130.1F00:00:00 P=740mm

alternating with...

STATUSOPEN DOOR

If the sterilizer door is not unlatched within five minutes, the control relocks thedoor and the sterilizer returns to the aerate phase.

NOTE: When pausing aeration or any other time the sterilizer door is to beopened prior to complete in-chamber aeration, the following procedure is to befollowed:

• Turn door handle to unlatch chamber door and crack door open approximatelytwo inches. Timer on display will start counting up from 0 and run continuouslyuntil door is closed and latched again or until aeration is aborted.

• Wait at least 15 minutes with door cracked open before fully openingchamber door. The operator (and other personnel nearby) must leave theimmediate area around the sterilizer during this period. CONTROL POWERmust remain ON during this fifteen minute period to provide electrical powerto the sterilizer.

While the sterilizer door is open, the display will show:

DOOR OPEN T=130.1F00:00:00 P=740mm

alternating with...

CLOSE DOORTO RESUME AERATION

alternating with...

PRESS RESET TO ABORT

6.5.3 Pausing AerationProcedure


STATUS

STATUS

STATUS

STATUS

STATUS

• After minimum 15-minute period, open chamber door to transfer any part ofthe load to a separate aeration unit or to remove any biological indicators.Wear personal protective equipment, including butyl rubber gloves whenhandling processed items. When aerating in a separate unit, remember to pullthe sterilized load from the sterilizer to the aerator so that the flow of air overthe load is away from the operator (see Sterilization Without Aeration). To abortaeration, press the RESET touch pad.

• Close and latch door to resume aeration.

If the cycle was set to have zero aeration, the following will be displayed:


alternating with:

PRESS 1 TO T=130.1FOPEN DOOR P=672mm

To open door, press the #1 touch pad and the display will change to:


alternating with...

WAIT TOOPEN DOOR


COMPLETE T=130.1FOPEN DOOR P=740mm

• Personnel monitoring is required when the aeration phase is omitted.

• Following sterilization without aeration, unlatch chamber door and crack itopen approximately two inches. Display window and printer will bothindicate door status.

• Wait at least fifteen minutes before removing sterilized goods fromsterilizer. The operator (and other personnel nearby) must leave theimmediate area around the sterilizer during this period. CONTROL POWERswitch must remain ON during this fifteen minute period to provide electricalpower to sterilizer.

6.5.4 Sterilizing WithoutAeration for 130oF (54oC)

Cycle



STATUS

STATUS

STATUS

STATUS

• Open chamber door and remove load.

NOTE: At completion of any cycle and sterilizer has door opened, the control willautomatically maintain temperature at previously selected cycle temperature ifthe CONTROL POWER Switch is left in the ON position and door is closed.

• Remove empty EO cartridge and place it on top of the load to be aerated.Wear personal protective equipment including butyl rubber gloves whenhandling EO cartridge and sterilized load.

When aerating in a separate unit, remember to pull the sterilized load from thesterilizer to the aerator so that flow of air over the load is away from the operator.

NOTE: When using the 100oF (38oC) cycle, note the following:• The sterilizer will idle at the set temperature that the previous cycle was

run at. If running a 100oF cycle after a 130oF (54oC) cycle was run, a cooldown period will be necessary. It is suggested that when a 100oF cycleis to be run after a 130oF cycle, the sterilizer be shut off at the completionof the 130oF cycle to allow cool down. Door should be open and poweroff during cool down.

• Minimum recommended aeration time at 100oF is 36 hours, unlessotherwise notified by the medical device manufacturer’s written process-ing instructions.

1. Follow instructions in Safety Guidelines for Ethylene Oxide (EO) Gas SterilizersM1846 (P62492-091) and Section 6.1, Before Operating the Equipment.

2. Display shows door status, such as:

When door is unlatched, display will read:

DOOR T= 93.2FUNLOCKED P=730mm



When door is latched, display will read:

TIME T= 93.2FHH:MM:SS (A/P) P=730mm



Once control power switch is turned on, chamber begins to heat (to 100oF).

6.6 AutomaticOperation 100oF

(38oC) CycleDescription

DANGER – ETHYLENE OX-IDE (EO): TOXIC. POSSIBLECANCER, REPRODUCTIVE,AND EXPLOSION HAZARD:

•Prior to using or servicingthis equipment, all employ-ees must review contents ofthe STERIS Safety GuidelinesEthylene Oxide (EO) GasSterilization Manual M1846(P62942-001). Contact STERISif you need a copy.

•The ethylene oxide sterilantused with this unit has toxicproperties. Use care in han-dling. Follow the proceduresprovided in Section 2 of thismanual.

•The chamber door(s) remainslocked until completion of theprogrammed exhaust or aera-tion phase or during powerfailure. In the case of powerfailure, continue or abort cyclewhen power is restored.


Figure 6-10. Lo-Temp 100oF Cycle - Typical Printout

NOTE: Cycle data printing is from bottom of tape to top of tape

Printout Key:C = ConditioningV = VacuumH = HumidifyP = PunctureS = SterilizeE = ExhaustA = Air wash and aerationZ = Complete


STATUS

STATUS

While the chamber is heating, the operator can install EO cartridge (seeSection 6.4, EO Cartridge Installation), load the sterilizer (refer to Section 3),then close and latch the doors.

3. After door is closed and latched, press and hold cycle #3 touch pad. Valuesfor the cycle are displayed. If values are acceptable, release touch pad andpress again to initiate the cycle.

Printer provides printout identifying cycle type.

Display will show:

DID YOU INSTALL GASCARTRIDGE? 1=YES

Press #1 touch pad if an EO cartridge has been installed in EO cartridgechamber recess. Control will proceed to Step 4.

If an EO cartridge has not been installed in the EO cartridge chamber recess,open sterilizer door, remove load, install EO cartridge (see Section 6.4, EOCartridge Installation), then load the sterilizer, and close and latch the sterilizerdoor. Refer back to Step 3 to continue.

4. Sterilizer enters Conditioning phase. Display shows:

CONDITION T= 93.2FP=730mm


NOTE: Printer provides printout data at all major cycle transition points.

5. Once the required vacuum level is reached, sterilizer enters the ChamberHeat phase. Display message is “Condition.”

During this phase, the chamber temperature is checked to ensure it is atproper operating temperature (100oF - 38oC).

6. Once the chamber is at proper temperature, sterilizer enters Vaporizer Heatphase. Display message is “Condition.”

During this phase, the vaporizer temperature is checked to ensure it is atproper operating temperature (205oF - 96oC).

7. Once the vaporizer is at proper temperature, sterilizer enters Vent Checkphase. Display message is “Condition.”

During this phase, the vent filter is checked to ensure that it is not plugged.Control opens vent valve for fixed time and checks for proper amount of ventpressure rise.

8. If the vent filter is not plugged, the printer records “Vent Pressure Rise” valueand chamber is evacuated to 120 mmHg (160 mBAR) then vacuum continuesfor three minutes. Display message is “Condition.”

9. After the three minute drawdown, sterilizer enters the Humidify phase.Display message changes to the following:


STATUS

STATUS

STATUS

STATUS

STATUS

STATUS


10. The humidify phase consists of four (4) humidity pulses to humidify the loadand the chamber. Each pulse phase is as follows:


• One minute humidity injection, then:

HUMIDIFY T= 99.4F 8:00 P=122mm

• Eight (8) minute humidity hold, then:

HUMIDIFY T=101.2FP=127mm

• Evacuation to minimum 120 mmHg (160 mBar) and continues evacu-ation for three more minutes.

11. Once the four humidify phases are complete, sterilizer enters anotherVacuum phase. Display message is “Humidify.”

During this phase, the chamber is evacuated 120 mmHg (160 mBAR) andcontinues evacuation for three more minutes.

12. Once the evacuation is complete, the sterilizer enters the Vacuum Testphase. Display message may momentarily display “Vac Test.”

During this phase, the chamber vacuum level is checked to ensure it is atproper vacuum minimum level of 96 mmHg (128 mBAR) and that no leaksare present.

13. Once the vac test is complete, the sterilizer enters the Charge phase. Thecartridge is punctured and EO gas enters the chamber. Display messagechanges to the following:

CHARGE T=101.0FP= 71mm




STATUS

STATUS

STATUS

Figure 6-11. 100oF Cycle Graph

14. Once chamber is fully charged with gas, unit enters Sterilize phase.Display message changes to the following:

NOTE: Sterilize timer starts fifty (50) seconds after EO cartridge is punctured.

STERILIZE T=100.7F 4:30:00 P=394mm



Remaining sterilize time is shown in hours, minutes and seconds. Sterilizephase is factory set for 4-1/2 hours. Printer records beginning and endingtimes of sterilize phase; and prints phase status every 15 minutes (factoryset) during the phase.

Sterilizer is factory set so that if chamber temperature drops more than 5oF(3oC) below set sterilizer temperature, the timer stops. If the set temperatureis reattained, sterilizer will resume counting down remaining sterilize time.

15. Once sterilize phase has timed out, sterilizer enters Exhaust (Post Vac)phase. Display shows:

EXHAUST T=100.7FP=391mm


STATUS

STATUS

STATUS

STATUS

STATUS




16. Once the required vacuum level is reached, sterilizer enters the Air Washphase. Display message changes to the following:

AIR WASH T=100.9F 30:00 P= 96mm



During this phase, the chamber air vent valve is opened and room air ispulled through the vaporizer (where it is heated) and through the chamberto the EO exhaust for 30 minutes. Vacuum level in the chamber during thisphase is not as deep as in the prevac phase. Time counts down from 30:00minutes to 0:00.

At the end of exhaust, the cycle will either continue with aeration (if aerationwas selected) or go to complete (sterilize only cycle). For operation withaeration, continue with the following. For sterilize only (without aeration),proceed to Section 6.6.4.

In order to further reduce potential worker exposure to EO, cycle WITHaeration MUST always be selected whenever possible.

Following air wash, sterilizer enters Aeration phase. Display message changesto the following:

AERATE T=100.56F36:00:00 P=676mm



6.6.1 Sterilizing withAeration for 100oF (38oC)

Cycle


STATUS

STATUS

STATUS

During this phase, air is pulled through the vaporizer (where it is heated) to theEO exhaust for 36 hours. Time counts down from 36:00:00 to 0:00.

The printer records beginning and ending times of aeration phase and printsphase status every 60 minutes (factory set) during the phase.

Sterilizer is factory set so that if chamber temperature drops more than 5°F (3°C)below set sterilizer temperature, the timer stops. If the set temperature isreattained, sterilizer will resume counting down remaining aeration time.

At this time, although not recommended, pressing the #1 touch pad causesthe aeration phase to pause. After following the Pausing Aeration procedurelisted in Section 6.6.2, the operator may move all or part of the load to a separateaeration unit, or remove biological indicators to determine efficacy of thesterilization phase. If the entire load is moved to a separate aeration unit, theaeration phase of the sterilizer cycle can be aborted. Otherwise, the aerationphase of the sterilizer cycle is to be resumed and completed.

NOTE: Minimum recommended aeration time at 100°F (38°C) is 36 hours, unlessotherwise notified by the medical device manufacturer’s written processinginstructions.

DO NOT open the sterilizer door before full aeration is completed withoutfollowing the “Pausing Aeration” procedure listed in Section 6.6.2.

When the set aeration time has been completed, the display shows:



NOTE: At completion of any cycle and sterilizer door is opened, the control willautomatically maintain chamber at previously selected cycle temperature if theCONTROL POWER Switch is left in the ON position and door is closed.

Remove the aerated empty EO cartridge and dispose of with non-incineratedwaste.

If the door is not opened within one minute standard aeration is resumed andthe display will show:


alternating with:



STATUS

STATUS

STATUS

STATUS

STATUS

STATUS

STATUS

To remove load, press the #1 touch pad and the display will change to:


alternating with...

WAIT TOOPEN DOOR


COMPLETE T=130.1FOPEN DOOR P=740mm


TO PREVENT INADVERTENT EXPOSURE, PERSONNEL MONITORING ISREQUIRED WHEN PAUSING DURING THE AERATION PHASE.

Although not recommended, if it is necessary to interrupt the aeration phase,press the #1 touch pad. The display will change from:

AERATE T=100.1F36:00:00 P=672mm

alternating with...


to:


alternating with...

WAIT TOOPEN DOOR

6.6.2 Pausing Aeration for100oF (38oC) Cycle



STATUS

STATUS

STATUS

STATUS

STATUS


OPEN DOOR T=100.1F00:00:00 P=672mm

alternating with...

OPEN DOOR

If the sterilizer door is not unlatched within five minutes, the control relocks thedoor and the sterilizer returns to the aerate phase.

NOTE: When pausing aeration, or any other time the sterilizer door is to beopened prior to complete in-chamber aeration, the following procedure is to befollowed:

• Turn door handle to unlatch chamber door and crack door open approximatelytwo inches. Timer on display will start counting up from 0 and run continuouslyuntil door is closed and latched again or until aeration is aborted.

• Wait at least 15 minutes with door cracked open before fully openingchamber door. The operator (and other personnel nearby) must leave theimmediate area around the sterilizer during this period. CONTROL POWERmust remain ON during this fifteen minute period to provide electrical powerto the sterilizer.

While the sterilizer door is open, the display will show:

DOOR OPEN T=100.1F00:00:00P=740MM

alternating with...

CLOSE DOORTO RESUME AERATION

alternating with...

PRESS RESET TO ABORT

• After minimum 15-minute period, open chamber door to transfer any part ofthe load to a separate aeration unit or to remove any biological indicators.

6.6.3 Pausing AerationProcedure


STATUS

STATUS

STATUS

STATUS

Wear personal protective equipment, including butyl rubber gloveswhen handling processed items. When aerating in a separate unit,remember to pull the sterilized load from the sterilizer to the aerator sothat the flow of air over the load is away from the operator (SeeSterilization Without Aeration). To abort aeration, press the RESET touchpad.

• Close and latch door to resume aeration.

STATUS

6.6.4 Sterilizing WithoutAeration For 100oF (38oC)

Cycle

If the cycle was set to have zero aeration, the following will be displayed:


alternating with:


To open door, press the #1 touch pad and the display will change to:


alternating with...

WAIT TOOPEN DOOR



• Personnel monitoring is required when the aeration phase is omitted.

• Following sterilization without aeration, unlatch chamber door and crack itopen approximately two inches. Display window and printer will bothindicate door status.

• Wait at least fifteen minutes before removing sterilized goods fromsterilizer. The operator (and other personnel nearby) must leave theimmediate area around the sterilizer during this period. CONTROL POWERswitch must remain ON during this fifteen minute period to provide electricalpower to sterilizer.



• Open chamber door and remove load.

NOTE: At completion of any cycle and sterilizer door is opened, the controlwill automatically maintain chamber at previously selected cycle tempera-ture if the CONTROL POWER Switch is left in the ON position.

• Remove empty EO cartridge and place it on top of the load to be aerated.Wear personal protective equipment including butyl rubber gloves whenhandling EO cartridge and sterilized load.

When aerating in a separate unit, remember to pull the sterilized load from thesterilizer to the aerator so that flow of air over the load is away from the operator.

7-1Operation of Units With EO Disposer Operator Manual 129353-701

The Amsco® EO Disposer™ requires a minimum of operator interface for properoperation. During normal operation, the 3017 sterilizer turns ON the Disposer asthe sterilizer enters the Sterilize phase. The Disposer heats up to operatingtemperature while the sterilizer is in Sterilize. As the sterilizer enters the Exhaustphase, EO from the sterilizer is exhausted to the Disposer.

Under normal conditions the operator is not required to interface with theDisposer, it is automatically done by the 3017 sterilizer.

The 50 CFM EO Disposer will operate with one or two 3017 sterilizers. Aninterface kit is necessary to connect the sterilizer(s) to the EO Disposer.

A sequencer cable is provided for connecting between two units beingexhausted to a single disposer.

The sterilizer display will not show any information on the Disposer unless thereis a fault. If the disposer is not ready when the sterilizer is ready to exhaust, thedisplay will state “Waiting For Disposer”. If the disposer takes too long tobecome ready, a “Disposer Not Ready” alarm and display will occur. Refer tothe Service and Maintenance Procedure (P129353-513) Troubleshooting Sec-tion to determine operator action.

There will be additional control boxes with displays present with a 3017/Disposer installation.

Interface Box. See Figure 7-1.

An interface box is normally mounted adjacent to the sterilizer. A series of LEDson the box indicate sterilizer/disposer operation. An explanation of each is asfollows:

POWER This indicates that the EO Disposer 220 VAC power isturned on.

DISPOSER ON This indicates that the 3017 Sterilizer has commandedthe Disposer to turn on.

VACUUM This LED is not functional in a 3017 installation and will notcome on.

DISPOSER READY This indicates that the Disposer has reached a minimumoperating temperature and has proper air flow.

READY OUT This indicates the interface box has communicated to the3017 sterilizer that the Disposer is ready to accept EO.

OVERTEMP This indicates the Disposer has exceeded normal oper-ating temperatures. If this occurs, call Service. Note thatin an overtemp condition, the DISPOSER READY andREADY OUT LEDs will not be lit.

AIR FLOW: This indicates that the proper air flow is not present. If thisoccurs, call service. Note that in an air flow condition, theDISPOSER READY and READY OUT LEDs will not be lit.

7OPERATION OF UNITS WITH EO DISPOSER

7.1 General

7.2 SterilizerDisplays

Figure 7-1. Interface Box

7.3 Control Boxes

7-2129353-701 Operator Manual Operation of Units With EO Disposer

CATALYST This indicates that the catalytic bed did not reachnormal working temperature during the exhaustphase. Repeated occurrences would indicate a needfor service.

It should be necessary for the operators to check this panel only if there isan alarm occurring with the 3017 sterilizer. This will help the serviceman todetermine the source of the fault.

The auto manual switch is to be in the auto position for normal operation. Themanual position is for service only.

191b202

8-1Documentation Reference Materials Operator Manual 129353-701

The documentation listed below is associated with the use and maintenance ofthe Amsco® Eagle® 3017 100% EO Sterilizer/Aerator:

Description Document Number

English Spanish French

• Uncrating Instructions 129353-585

• Installation Instructions 129353-511

• Equipment Manual -Service and MaintenanceProcdures 129353-707

• Equipment Manual -Operating Instructions 129353-701 129353-702 129353-703

• Illustrated PartsBreakdown 129353-704

• Tech Data SD578 SD619 SD620

• Tech Data - Eagle 3000Remote Control SD479

• Tips on ImprovingSterilization Techniques ED-1099

• STERIS Safety M1846Guidelines Publication (62942-091)

• STERIS SterilantCartridge InformationBrochure 129353-710

• Equipment Drawing 65435-641

• Preparing Instruments,Utensils, and Textiles forSterilizers and Wet PackProblem Solving M1844

Model Eagle 3017 Supply Reorder Numbers

Description Reorder Number

• EO Gas Cartridges - Domestic(One Case of 12 Cartridges) PB-013

• EO Gas Cartridges - International(One Case of 12 Cartridges) PB-015

DOCUMENTATION REFERENCE MATERIAL 8

DANGER – ETHYLENE OX-IDE (EO): TOXIC. POSSIBLECANCER, REPRODUCTIVE,AND EXPLOSION HAZARD:Employment of inexperi-enced, unqualified personsto work on the equipment orthe installation of unautho-rized parts could cause per-sonal injury or result incostly damage. Repairs andadjustments other thanthose described in thismanual must be attemptedonly by an experienced tech-nician fully acquainted withthis equipment using appro-priate servicing proceduresper Service and MaintenanceProcedures (P129353-707),and in accordance withSTERIS Safety GuidelinesM1846 (P62942-091).

DANGER – EXPLOSION ANDFIRE HAZARD:

•EO cartridges must be storedat a temperature less than100oF (38oC).

•Maintain only one day’s sup-ply or a maximum of twenty-four EO cartridges (two boxes)in the immediate sterilizerarea, having a minimum often air changes per hour.

•Store additional EO car-tridges in an approved flam-mable liquid storage compart-ment or cabinet which isvented to outside exhaust sys-tem. Check the local fire pro-tection codes for additionalrequirements.

Documents

Amsco Eagle 3017 Operator Manual (1)