STERIS VHPX10 VHP X10 Biodecontamination Unit User Manual 10087252

STERIS Corporation VHP X10 Biodecontamination Unit 10087252

Contents

Users Manual

OPERATOR MANUALX10™ Biodecontamination Unit(TEAM) 10087252
iIntroduction Operator Manual 10087252A WORD FROM STERIS CORPORATION©2014, STERIS Corporation. All rights reserved. Printed in U.S.A.Thank you for choosing this fine STERIS Life Sciences product. STERISis committed to ensuring your continued satisfaction. This manualcontains important information on proper use and maintenance of theX10™ Biodecontamination Unit. All personnel involved in the useand maintenance of this equipment must carefully review andcomply with the SAFETY PRECAUTIONS and instructions containedin this manual and the Vaprox® 59 Hydrogen Peroxide SterilantSafety Data Sheet (SDS), product label and package insert. Theseinstructions are important to protect the health and safety of personneloperating the X10 Biodecontamination Unit and should be retained in aconveniently accessible area for quick reference.Complete instructions for uncrating and installing this unit, as well asequipment drawings, have been furnished. If missing, contactSTERIS Life Sciences for replacement copies, giving the serial,equipment and model numbers of the Biodecontamination Unit.NOTE: Refer to SECTION 2 of this manual for a listing of Terms,Definitions and Symbols that may appear in this manual or on yourequipment.Advisory A listing of the SAFETY PRECAUTIONS to be observed when operatingand servicing this X10 Biodecontamination Unit and/or handling theSterilant is found in SECTION 1 of this manual or on the containerlabel. Do not operate or service the equipment or handle the Sterilantuntil you have become familiar with this information.Any alteration of the unit not authorized or performed by STERIS LifeSciences voids the warranty, could adversely affect Biodecontaminationefficacy, and could violate national, state and local regulations.Vaprox 59 Hydrogen Peroxide Sterilant have been EPA registered bySTERIS in accordance with Federal Regulations for the specific usesdescribed in this manual. The X10 Biodecontamination Unit must beused only on Enclosures (refer to SECTION 2.1, TERMS ANDDEFINITIONS) that have been pre-cleaned and dried per facilityprocess and current protocols. Please refer to the Vaprox 59Hydrogen Peroxide Sterilant package insert for additionalinformation and application instructions.IMPORTANT: A listing of the SAFETY PRECAUTIONS to be observed when operating and servicing thisequipment and/or handling Vaprox 59 Hydrogen Peroxide Sterilant can be found in SECTION 1 of thismanual. Do not operate or service the equipment or handle the Sterilant until you have been trainedand certified on this information as well as the information on the Vaprox 59 Hydrogen PeroxideSterilant product label and package insert.IMPORTANT: Please refer to SECTION 2.1, TERMS AND DEFINITIONS, for a list of terminology used inthis document. This manual describes the STERIS Biodecontamination Process using Vaprox 59Hydrogen Peroxide Sterilant. The U.S. EPA has registered Vaprox 59 Hydrogen Peroxide Sterilant(EPA Reg. No. 1043-123) and its use. Refer to either the Vaprox 59 Hydrogen Peroxide Sterilantlabel and package insert for detailed Safety Precautions and application instructions.
ii10087252 Operator Manual IntroductionIntended Use NOTE: The X10 Biodecontamination Unit is to be used by Trainedand Certified Applicators who have successfully completed both theSTERIS Training and Certification Course for Applicators of VaproxHydrogen Peroxide Sterilant and the X10 Biodecontamination UnitOperator Course. Certification must be active and in force for allApplicators of Vaprox 59 Hydrogen Peroxide Sterilant.The X10 Biodecontamination Unit is designed for mobileBiodecontamination of clean, dry, sealed Enclosures (refer toSECTION 2.1, TERMS AND DEFINITIONS) of three, four, five and six footwidths with corresponding internal volumes from 15.6 - 31.2 ft3 (.44 -.88 m3) using STERIS’s patented VHP® Process Technology andusing Vaprox 59 Hydrogen Peroxide Sterilant. Uses other than as specified and described in this manual are notrecommended and may not be effective or safe in operating theBiodecontamination Unit. Consult this manual or STERIS LifeSciences for further information. The Biodecontamination Unit utilizes specially designed disposable70 mL Cups* of Vaprox 59 Hydrogen Peroxide Sterilant.*Available separately for purchase.Introduction The STERIS X10 Biodecontamination Unit offers fast, economicalBiodecontamination of Enclosures (refer to SECTION 2.1, TERMS ANDDEFINITIONS).The Biodecontamination Unit uses STERIS's patented VHP ProcessTechnology. This process utilizes hydrogen peroxide vapor as abroad spectrum anti-microbial without condensation of the activeingredient onto surfaces with good material compatibility.The Biodecontamination Unit comes with two programmed cyclesdesigned to achieve a minimum of a 6-log bioburden reduction in aClass II Type A2 Biological Safety Cabinet:1. Cycle 1 for 3 - 4' (0.9 - 1.2 m)2. Cycle 2 for 5 - 6' (1.5 - 1.8 m)The X10 features X-Phase hardware technology and VaproxLinksoftware technology. X-Phase hardware technology features arotating cylinder design that enables heating, dehumidification,conditioning, Biodecontamination and aeration for an All-In-One unitdesign while VaproxLink software technology automatically identifiesVaprox 59 Hydrogen Peroxide Sterilant Cup and verifies expirationdate.With 0.5-2.5 g/min of Sterilant injection, the Biodecontamination Unitis capable of Biodecontaminating a single Class II Type A2 cabinetfrom 3 - 6' (0.9 - 1.8 m) with internal cabinet volume up to 31.2 ft3(.88 m3).The X10 Biodecontamination Unit is multi-lingual (English, French,Spanish, Italian and German) and available in either 120 or 230 Vac,single phase, electrical service.DANGER – FIRE AND EXPLOSION HAZARD: • Verify all materials coming in contact with hydrogen peroxide are compatible with oxidizers. Contact STERIS Life Sciences or the material manufacturer for information on material compatibility.• This Biodecontamination Unit is not designed to process flammable liquids. Do not process liquids, linens, powders or any cellulose materials. Process only those materials compatible with hydrogen peroxide.
iiiIntroduction Operator Manual 10087252Service InformationA thorough preventive maintenance program is essential to safe andproper equipment operation. Comprehensive instructions for monthly,quarterly and semi-annual preventive maintenance can be found in theMaintenance Manual (available from STERIS Life Sciences).Only STERIS-trained personnel should attempt to perform maintenanceon the X10 Biodecontamination Unit to avoid personal injury, improperequipment performance, invalidation of the warranty or other costlydamage. Customers are encouraged to contact STERIS Life Sciences concerningour annual maintenance program. Under the terms of the program,preventive maintenance, adjustments and replacement of worn parts areprovided on a scheduled basis to help ensure optimal equipmentperformance and to help minimize untimely or costly scheduleinterruptions. STERIS Life Sciences maintains a worldwide staff of well-equipped, factory-trained technicians to provide these services, as wellas on-site installation, training and expert repair services. ContactSTERIS Life Sciences** for details.**1 (800) 440-9009 or www.sterislifesciences.com.
iv10087252 Operator Manual IntroductionThe base language of this document isENGLISH. Any translations must bemade from the base language document.EC Authorized RepresentativeSTERIS Ltd.Chancery House190 Waterside RoadHamilton Industrial ParkLeicester LE5 1QZ UKSTERIS Corporation5960 Heisley RoadMentor, OH 44060-1834 USA440-354-2600 • 800-444-9009 www.steris.comSTERIS CORPORATION6515 Hopkins RoadMentor, OH 44060 • USA
vTable of Contents Operator Manual 10087252TABLE OF CONTENTSSection Number Description Page1 Safety Precautions ........................................................................................................................ 1-12 Terms, Definitions and Symbols.................................................................................................. 2-12.1 Terms and Definitions ............................................................................................................................ 2-12.2 Symbols ................................................................................................................................................. 2-33 Operating Instructions .................................................................................................................. 3-13.1 Introduction ............................................................................................................................................ 3-13.2 Operation ............................................................................................................................................... 3-23.2.1 Attach to Enclosure .................................................................................................................. 3-23.2.2 Prepare Enclosure and Biodecontamination Unit..................................................................... 3-43.2.3 Cycle Completion ..................................................................................................................... 3-64 Troubleshooting ............................................................................................................................ 4-14.1 Troubleshooting ..................................................................................................................................... 4-15 Routine Maintenance..................................................................................................................... 5-15.1 Read Before Performing Routine Maintenance ..................................................................................... 5-15.2 Clean Biodecontamination Unit ............................................................................................................. 5-25.3 Clean Hoses .......................................................................................................................................... 5-35.4 Cleaning Touch Screen ......................................................................................................................... 5-45.5 Replacement Parts and Supplies .......................................................................................................... 5-45.5.1 Ordering Information ................................................................................................................ 5-45.5.2 Supply Products ....................................................................................................................... 5-55.5.3 Recommended Spare Parts ..................................................................................................... 5-55.6 Associated Publications........................................................................................................................ 5-66 Supplemental Information ............................................................................................................ 6-16.1 Installation Verification........................................................................................................................... 6-16.1.1 Installation Checklist................................................................................................................. 6-16.1.2 Pre-Operation Checklist ........................................................................................................... 6-16.2 Technical Data ....................................................................................................................................... 6-26.2.1 Overall Size (W x H x D) .......................................................................................................... 6-26.2.2 Weight ...................................................................................................................................... 6-26.2.3 Electric Requirements .............................................................................................................. 6-26.2.4 Environmental Conditions ........................................................................................................ 6-26.3 Hydrogen Peroxide Biodecontamination ............................................................................................... 6-36.4 Biodecontamination Cycle ..................................................................................................................... 6-36.5 Hydrogen Peroxide Handling Precautions ............................................................................................. 6-5
vi10087252 Operator Manual Table of ContentsSection Number Description PageTABLE OF CONTENTS (CONT’D)6.6 Sterilant Cup Installation and Removal................................................................................................. 6-66.6.1 Cup Installation......................................................................................................................... 6-76.6.2 Cup Removal............................................................................................................................ 6-76.6.3 Disposal of Sterilant From Cup ................................................................................................ 6-86.7 Desiccant Installation and Removal....................................................................................................... 6-86.8 Sterilant Container Storage .................................................................................................................. 6-96.9 General Component Identification ......................................................................................................... 6-96.10 Operation ............................................................................................................................................. 6-10
viiTable of Contents Operator Manual 10087252LIST OF FIGURESDescription PageFigure 3-1. VHP X10 Biodecontamination Unit in Cases ..............................................................................3-3Figure 3-2. Open Biodecontamination Unit Case..........................................................................................3-3Figure 3-3. Accessory Case Components ....................................................................................................3-3Figure 3-4. Connect Biodecontamination Unit to Enclosure .........................................................................3-4Figure 3-5. Open Supply Door ......................................................................................................................3-5Figure 3-6. Connecting X10 Biodecontamination Unit and AR60 Aerator to Enclosure ...............................3-6Figure 6-1. X10 Biodecontamination Unit .....................................................................................................6-3Figure 6-2. Typical Biodecontamination Cycle..............................................................................................6-4Figure 6-3. Typical Sterilant Cup...................................................................................................................6-6Figure 6-4. Sterilant Cup in Biodecontamination Unit (Typical) ....................................................................6-7Figure 6-5. Carefully Insert Draw Tube (Typical) ..........................................................................................6-7Figure 6-6. Desiccant Cartridge (Typical) .....................................................................................................6-8Figure 6-7. Place Desiccant Cartridge in Biodecontamination Unit ..............................................................6-9Figure 6-8. Component Identification ..........................................................................................................6-10
viii129396-083 Operator Manual Table of ContentsLifeSciences
xiTable of Contents Operator Manual 10087252LIST OF TABLESTable Number Description PageTable 2-1 Definition of Symbols....................................................................................................................... 2-3Table 4-1 Alarm/Abort Actions......................................................................................................................... 4-1Table 4-2 Power Interruption/Power-Up Actions ............................................................................................. 4-1Table 4-3 Troubleshooting Guide .................................................................................................................... 4-2Table 5-1 VHP X10 Biodecontamination Unit Selected Supply Products ....................................................... 5-5Table 5-2 Recommended Spare Parts ............................................................................................................ 5-5Table 5-3 Associated Publications .................................................................................................................. 5-6
xii10087252 Operator Manual Table of ContentsLifeSciences
1-1Safety Precautions Operating Manual 100872521NOTE: Refer to SECTION 2 of this manual for a listing of Terms, Definitions and Symbols that may appear in thismanual or on your equipment.The following Safety Precautions must be observed when operating or servicing this STERIS X10™Biodecontamination Unit and when handling Vaprox® 59 Hydrogen Peroxide Sterilant Cups. Safety Precautionsare divided as follows:•DANGER indicates personal injury or substantial property damage results if proper precautions are nottaken. •WARNING indicates the potential for personal injury and/or potential for property damage may result if properprecautions are not taken. •CAUTION indicates the potential for damage to equipment may result if proper precautions are not taken.For emphasis, certain Safety Precautions are repeated throughout the manual. It is important to review ALLSafety Precautions before operating or servicing the unit. Also read the Vaprox 59 Hydrogen PeroxideSterilant SDS for additional information on the proper use and handling of hydrogen peroxide.STERIS recommends that all operators should be regularly trained in the operation and safe usage of theequipment, including emergency procedures for any harmful material released into the environment. Records ofattendance at training shall be maintained and evidence of understanding shall be demonstrated.NOTE: Disregarding the presented safety information is considered ABNORMAL USE of this product. If theequipment is used in a manner not specified by STERIS, the protection provided by the equipment may be impaired.DANGER – SLIPPING HAZARD:DANGER – FIRE AND EXPLOSION HAZARD:Water or hydrogen peroxide spilled on the floor presents a slipping hazard – promptly clean up the spill. If in doubt whether the liquid is water or hydrogen peroxide, test the liquid using a Liquid Hydrogen Peroxide Test Strip (follow manufacturer's instructions), before wiping up. If the liquid is hydrogen peroxide, contain the spill and dilute with water (at least 20 parts water to one part H2O2) prior to wiping up. Observe all hydrogen peroxide handling precautions. Refer to the Vaprox 59 Hydrogen Peroxide Sterilant SDS for spill containment and cleanup.Liquid hydrogen peroxide is a strong oxidant and poses a FIRE, EXPLOSION OR CONTAINER RUPTURE HAZARD. Avoid excessive heat, contamination or contact with combustible materials. Clothing, shoes or other combustible materials that have come in contact with hydrogen peroxide must be immediately and thoroughly washed with water. Discard shoes contaminated with Vaprox 59 Hydrogen Peroxide Sterilant in a fireproof container. If Vaprox Sterilant is allowed to dry in the materials, a fire may result. IN CASE OF FIRE, use water only. CONTAIN SPILLS and dilute with water (at least 20 parts water to one part H2O2). After diluting the spill, sodium metabisulfide or sodium sulfite (1.9 lb of SO2 equivalent per 500 mL of H2O2) may be used to destroy the peroxide. SEE SDS FOR ADDITIONAL INFORMATION. EFFECTS MAY BE DELAYED.Verify all materials coming in contact with hydrogen peroxide, especially the concentrated liquid, are compatible with oxidizers. Contact STERIS Life Sciences or the material manufacturer for information on material compatibility.This Biodecontamination Unit is not designed to process flammable liquids. Do not process liquids, linens, powders or any cellulose materials. Process only those materials compatible with hydrogen peroxide.SAFETY PRECAUTIONS 1
1-210087252 Operating Manual Safety PrecautionsDANGER – PERSONAL INJURY, CONTAMINATED ENCLOSURE AND/OR EQUIPMENT DAMAGE HAZARD:DANGER – CHEMICAL INJURY HAZARD:Use only Vaprox 59 Hydrogen Peroxide Sterilant Containers, containing STERIS-registered hydrogen peroxide which has been specially formulated, tested and approved for use in this X10 Biodecontamination Unit. Vaprox 59 Hydrogen Peroxide Sterilant has been registered by STERIS in accordance with U.S. Federal Regulations for the specific uses described in this manual. Use of other materials and/or H2O2 other than Vaprox 59 Hydrogen Peroxide Sterilant could impair equipment operation, result in costly repairs, result in an ineffective Biodecontamination Cycle, violate federal law and void the equipment warranty.Before using Vaprox 59 Hydrogen Peroxide Sterilant, check the expiration date. Do not use a Sterilant if it is beyond its expiration date, or if it will not be fully used before its expiration date.When using a Vaprox 59 Hydrogen Peroxide Sterilant Cup, always wear appropriate Personal Protective Equipment (refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE), keep the Cup upright and do not squeeze.Before disposing of a Vaprox 59 Hydrogen Peroxide Sterilant Cup, empty all remaining Cup contents into a sink with running water (at least 20 parts water to one part Vaprox H2O2), then carefully triple rinse the Cup with tap water.Before starting a cycle, check Sterilant to ensure it is not expired.No one may open a sealed Enclosure during or after an aborted cycle without PPE (refer to Sterilant SDS for PPE) if Sterilant levels within the treated Enclosure are above one PPM. Refer to Sterilant label and package insert for instructions.When handling hydrogen peroxide, wear appropriate PPE (refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE) and observe all Safety Precautions. See Vaprox 59 Hydrogen Peroxide Sterilant SDS, product label and package insert for additional handling information.CORROSIVE. Causes irreversible eye damage or skin burns. May be fatal if inhaled. Harmful if swallowed or absorbed through the skin. Do not get in eyes, on skin or on clothing. Do not breathe spray mist. Prolonged or frequently repeated skin contact may cause allergic reaction in some individuals. User should wash hands before eating, drinking, chewing gum, using tobacco or using the toilet. User should remove contaminated clothing and wash before reuse. Applicators and all other handlers must wear PPE (refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE). See Vaprox 59 Hydrogen Peroxide Sterilant product label and package insert for additional handling information.When handling the Biodecontamination System hoses, wear appropriate PPE (refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE). Any visible liquid in the hoses must be treated as concentrated hydrogen peroxide and all hydrogen peroxide handling precautions must be observed.If power has been interrupted, do not attempt to access the Enclosure (refer to SECTION 2.1, TERMS AND DEFINITIONS). Hydrogen peroxide may be present in the Enclosure. Read the manufacturer operating instructions before attempting to use the low level hydrogen peroxide monitor.
1-3Safety Precautions Operating Manual 10087252DANGER – CHEMICAL INJURY HAZARD (Cont’d):When handling Vaprox 59 Hydrogen Peroxide Sterilant Cups, note the following:• Use extreme caution when handling a damaged, leaking or expired hydrogen peroxide Cup. Always wear appropriate PPE (refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE) when handling damaged, leaking or expired Cups, or when wiping up hydrogen peroxide spills.• When handling a Cup under water, do not allow your glove openings to go below the surface of the water permitting liquid to enter the gloves. • A Vaprox 59 Hydrogen Peroxide Sterilant Cup must be in the Cup holder at all times. When no Cup is in place, concentrated liquid hydrogen peroxide may drip from the Cup connector.Before running a Biodecontamination Cycle, always verify that the Biodecontamination Unit is properly connected to the sealed Enclosure (refer to SECTION 2.1, TERMS AND DEFINITIONS) to ensure complete containment of the hydrogen peroxide vapors (check hose connections and ensure all Enclosure vents/ports are sealed). Post warning signs on and around the treated Enclosure to prevent accidental entry during the Biodecontamination Cycle. Refer to the Vaprox 59 Hydrogen Peroxide Sterilant label and package insert for specific detailed instructions.When the control panel warning light is ON, harmful Sterilant vapors are present within the Enclosure (refer to SECTION 2.1, TERMS AND DEFINITIONS). Do not access the Enclosure. If it is necessary to access the Enclosure being processed under these conditions before the end of the Aeration phase or after an aborted Cycle, wear appropriate PPE (refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE). Ensure no skin is exposed. Follow all re-entry protocols listed on the Vaprox 59 Hydrogen Peroxide Sterilant label and package insert.At the end of the Aeration phase, use a low level hydrogen peroxide monitor to check and periodically monitor the hydrogen peroxide vapor concentration within the Enclosure (refer to SECTION 2.1, TERMS AND DEFINITIONS). The hydrogen peroxide vapor concentration should be at or below established levels before the Enclosure is accessed by Trained and Certified Applicators. The Vaprox 59 Hydrogen Peroxide Sterilant label and package insert contain required hydrogen peroxide limits for re-entry and releasing of the Enclosure after Biodecontamination.Any visible liquids in the Enclosure (refer to SECTION 2.1, TERMS AND DEFINITIONS) must be treated as concentrated hydrogen peroxide. Always test residual liquids, using a Liquid Hydrogen Peroxide test strip (follow manufacturer's instructions), before diluting and wiping up. Observe all hydrogen peroxide handling precautions presented in the Vaprox 59 Hydrogen Peroxide Sterilant SDS, product label and package insert. The Biodecontamination Unit generates harmful hydrogen peroxide vapor and discharges it from the Outlet port. Always ensure all connections are vapor tight and that the Enclosure (refer to SECTION 2.1, TERMS AND DEFINITIONS) is properly sealed, secured and placarded as described on the Vaprox 59 Hydrogen Peroxide Sterilant label and package insert. Heed this Safety Precaution to ensure, under normal conditions, the Biodecontamination Unit and Enclosure do not leak H2O2 vapor.
1-410087252 Operating Manual Safety PrecautionsWARNING – PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD:WARNING – ELECTRIC SHOCK HAZARD:CAUTION – POSSIBLE EQUIPMENT DAMAGE:REMEMBER – POSSIBLE TIME DELAY:Repairs and adjustments to this equipment must be made only by STERIS Life Sciences or STERIS-trained service personnel. Maintenance performed by unqualified personnel or installation of unauthorized parts could cause personal injury, impair equipment protection design, result in improper equipment performance, invalidate the warranty or result in costly damage. Contact STERIS Life Sciences regarding service options. Regularly scheduled preventive maintenance is required for safe and reliable operation of this equipment. Contact STERIS Life Sciences to schedule preventive maintenance. Lifting the Biodecontamination Unit requires more than one person. The unit weighs approximately 68 lb (31 kg). Place the Biodecontamination Unit only on flat surfaces. Various internal components are designed for operation when Unit is placed on a level, flat surface. Ensure the Biodecontamination Unit is positioned so access to power switch and facility outlet are not restricted. To disconnect Biodecontamination Unit, pull cord from facility outlet. The power switch is NOT intended to be used as a means of disconnect.Integrated (temperature and humidity) sensors are fragile. Do not bang, twist or crush. Biodecontamination Unit does not operate properly with a damaged sensor.Disconnect electrical power source to equipment (pull plug from facility outlet) before attempting to access the Biodecontamination Unit. The power switch is NOT intended to be used as a means of disconnect.Use nonabrasive cleaners when cleaning unit. If you need technical assistance or additional instructions, call STERIS Life Sciences.• Follow all directions on container. • Do not use abrasive cleaners on plastic surfaces. • Avoid detergents with bases, aromatics, ketones, esters and chlorinated hydrocarbons.• Avoid contacting plastic surfaces with greases and oils.Keep connecting hoses off the floor. If supply connecting hoses rest on cool floors or other cool surfaces, hydrogen peroxide may condense in the hoses. Place a support under the hoses (e.g., lash hoses to plastic easel or plastic tripod) to prevent kinks and undue strain on the hose connections.Use only Distilled Water for the hydrogen peroxide piping purge. Use of tap water will damage the vaporizer.Insufficient clearance space will make repairs more difficult and time-consuming. Refer to the equipment drawing for minimum clearance for service/maintenance access requirements.
2-1Terms, Definitions and Symbols Operator Manual 100872522.1 Terms andDefinitionsAeration – Final phase of a Biodecontamination Cycle. Allows for re-entry into treated, sealed Enclosures once the Sterilant concentrationlevels are at or below permissible levels. Typical H2O2 concentration≤1 PPM.BI – Biological Indicator used for Biodecontamination Cycleevaluation. Typically E6 Geobacillus stearothermophilus is used.Biodecontamination1 – Third phase of the Biodecontamination Cycleor the obtaining of bioburden reduction targets in a sealed Enclosure.Biodecontamination Cycle1 – Represents the complete process(Biodecontamination) from start to finish which may includeDehumidify, Condition, Biodecontamination and Aeration phases.Biodecontamination Unit – STERIS X10™ Biodecontamination Unit.Catalytic Converter – A component of the Biodecontamination Unitutilizing a catalyst to degrade H2O2 into water vapor and oxygen.CI – Chemical Indicator used for Biodecontamination Cycle validationand Sterilant mapping.Condition – Second phase of the Biodecontamination Cycle. Sterilantis added to the sealed Enclosure to reach the target concentrationneeded for the Biodecontamination phase.Cup – Vaprox® 59 Hydrogen Peroxide Sterilant container, 70 mL.Dehumidify – First phase of the Biodecontamination Cycle. Achievestemperature and humidity conditions necessary for subsequentBiodecontamination phases.Enclosure – Contained area to be Biodecontaminated (e.g., Class IIType A2 Biosafety Cabinet).FMP – Fumigation Management Plan.2HMI – Human Machine Interface (such as the control display).H2O2 or H2O2 – Hydrogen peroxide.I/O – Input/Output.PLC – Programmable Logic Controller.1When using STERIS X10 Biodecontamination Units with Vaprox 59 Hydrogen Peroxide Sterilant in the United States, the termBiodecontamination referred to in this Operator Manual is defined as Sterilization of exposed porous and non-porous surfaces in a precleaned,dry, sealed Enclosure. Any reference to Biodecontamination as it relates to the use of this equipment in the United States does not impartadditional claims of effectiveness beyond that approved in the EPA registered labeling of Vaprox 59 Hydrogen Peroxide Sterilant for use onprecleaned, dry, exposed porous and non-porous surfaces in a sealed Enclosure.2Guidance for developing a suitable Fumigation Management Plan can be found in STERIS publication (P129383-938) or searching EPAwebsite (epa.gov) for the key words ’Vaprox Package Insert.’ Continued ...TERMS, DEFINITIONS AND SYMBOLS 2
2-210087252 Operator Manual Terms, Definitions and SymbolsTerms and Definitions(Cont’d)PPE – Personal Protective Equipment including goggles or faceshield, chemical-resistant gloves (barrier laminate, butyl rubber, nitrilerubber, neoprene rubber, polyvinyl chloride, or Viton®3) and SCBA(Self-Contained Breathing Apparatus) if hydrogen peroxideconcentrations exceed one ppm during handling/or application ofSterilant. Refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS forappropriate PPE.RH – Relative Humidity.SCBA – Self-Contained Breathing Apparatus.scfm – Standard Cubic Feet per Minute.scmh – Standard Cubic Meters per Hour.SDS – Material Data Sheet.Sporicidal – Antimicrobial activity which destroys or eliminates allforms of microbial life including hard-to-kill microbial spores.SSR – Solid State Relay.Sterilant – Vaprox 59 Hydrogen Peroxide Sterilant (STERIS EPA-registered, 1043-123, 59%). Sterilant contains stabilizers and otheradditives making it suitable for STERIS VHP BiodecontaminationUnits.Sterilization – Complete killing of all microbial life including spores.Unit – Biodecontamination Unit.USB – Universal Serial Bus. Industry standard defining cables,connectors and communication protocols used in a bus forconnection, communication and power supply between computersand electronic devices.Vac – Volts Alternating Current.Vdc – Volts Direct Current.VHP – STERIS proprietary process technology utilizing H2O2 vapor asa broad spectrum anti-microbial without condensation of the activeingredient on the surfaces.3 Viton is a registered trademark of DuPont Performance Elastomers.
2-32.2 Symbols Table 2-1 contains symbols which may appear on your STERIS X10Biodecontamination Unit components. Table 2-1. Definition of SymbolsSymbol DefinitionProtective Earth (Ground)Electrostatic Sensitive DeviceElectric Shock HazardAttention, Consult Manual for Further InstructionsThis Product Has Been Tested To The Requirements Of CAN/CSA-C22.2No. 61010-1, Second Edition, Including Amendment 1, Or A Later VersionOf The Same Standard Incorporating The Same Level Of TestingRequirementsInlet Sterilant Hose Connection (From Enclosure Exhaust Into Biodecontamination Unit)Outlet Sterilant Hose Connection (From Biodecontamination Unit IntoEnclosure Work Area)SN Serial Number of UnitV~ Voltage Rating of Unit, Alternating CurrentAAmperage Rating of UnitHz Frequency Rating of UnitφPhase of Unit
2-410087252 Operator Manual Terms, Definitions and SymbolsLifeSciences
3-1Operating Instructions Operator Manual 10087252NOTE: Uses other than as specified and described in this section, onthe Sterilant label and/or package insert are not recommended, maynot be effective in Biodecontamination, and may not be safe. Pleasecontact STERIS Life Sciences for appropriate guidance, in-serviceand training.3.1 Introduction NOTE: Refer to SECTION 2 of this manual for a listing of Terms,Definitions and Symbols that may appear in this manual or on yourequipment.The STERIS VHP X10™ Biodecontamination Unit, using STERIS'spatented VHP Process Technology, offers fast, economicalbiodecontamination of Enclosures.This process utilizes H2O2 vapor as a broad spectrum anti-microbial.There is no condensation of the active ingredient onto surfaces andSterilant has good material compatibility.The Biodecontamination Unit comes with two programmed cyclesdesigned to achieve a minimum of a 6-log bioburden reduction in anEnclosure (Class II Type A2 Biological Safety Cabinet):•Cycle 1 - 3 - 4' (0.9 - 1.2 m)•Cycle 2 - 5 - 6' (1.5 - 1.8 m)The STERIS X10 Biodecontamination Unit features X-Phase hardwaretechnology and VaproxLink software technology. X-Phase hardwaretechnology features a rotating cylinder design that enables heating andBiodecontamination Cycle phases (Dehumidification, Conditioning,Biodecontamination and Aeration) for an All-In-One unit design whileVaproxLink software technology automatically identifies Vaprox® 59Hydrogen Peroxide Sterilant Cup and verifies expiration date.Other X10 Biodecontamination Unit features:• With 0.5 - 2.5 g/min of Sterilant injection, the BiodecontaminationUnit is capable of Biodecontaminating a single Class II Type A2cabinet from 3 - 6' (0.9 - 1.8 m) with an internal cabinet volume ofup to 31.2 ft3 (.88 m3). • Biodecontamination Unit operates outside (with the addition ofSash Support Plate and Exhaust Plenum Adapter) the Enclosureand can operate as a stand alone Biodecontamination Unit. IMPORTANT: A listing of the SAFETY PRECAUTIONS to be observed when operating and servicing thisequipment and/or handling Vaprox® 59 Hydrogen Peroxide Sterilant can be found in SECTION 1 ofthis manual. Do not operate or service the equipment or handle the Sterilant until you have beentrained and certified on this information as well as the information on the Vaprox 59 HydrogenPeroxide Sterilant product label and package insert.IMPORTANT: Please refer to SECTION 2.1, TERMS AND DEFINITIONS, for a list of terminology used inthis document. This manual describes the STERIS Biodecontamination Process using Vaprox 59Hydrogen Peroxide Sterilant. The U.S. EPA has registered Vaprox 59 Hydrogen Peroxide Sterilant(EPA Reg. No. 1043-123) and its use. Refer to either the Vaprox 59 Hydrogen Peroxide Sterilantlabel and package insert for detailed Safety Precautions and application instructions.OPERATING INSTRUCTIONS 3
3-210087252 Operator Manual Operating Instructions• All Biodecontamination Cycle data is output to a USB interface inencrypted format for data storage.• Biodecontamination Unit is easily transported in a light weightand IP20 rated case (with retractable handle and wheels).•A separate AR60™ Aerator is available for catalyzing sterilant forapplications requiring faster aeration time.• The X10 Biodecontamination Unit is multi-lingual (English,French, Spanish, Italian and German) and available in either 120or 230 Vac, single phase electrical service.• To minimize exposure to liquid Sterilant during handling, thesystem uses specially designed disposable Cups containingapproximately 70 mL of Vaprox 59 Hydrogen Peroxide Sterilant. 3.2 Operation NOTE: The STERIS X10 Biodecontamination Unit is to be used byTrained and Certified Applicators who have successfully completedboth the STERIS Training and Certification Course for applicators ofVaprox 59 Hydrogen Peroxide Sterilant and the STERIS X10Biodecontamination Unit Operator Course. Certification must beactive and in force for all Applicators of Vaprox 59 Hydrogen PeroxideSterilant.3.2.1 Attach to Enclosure The following information is intended to enable a Trained andCertified Applicator to properly attach the Biodecontamination Unitto an Enclosure (refer to SECTION 2.1, TERMS AND DEFINITIONS):1. Review site-specific FMP* and verify all accessories are present (if applicable) and proper location of Biodecontamination Unit. 2. Consult with facility officials on Safety Precautions, security,warning placards and other facility requirements. 3. Position Biodecontamination Unit and any needed accessoriescases near Enclosure (see Figure 3-1). NOTE: Ensure Biodecontamination Unit is within 10’ (3 m) of thefacility power outlet. Use of extension cords is not recommended.*Guidance for developing a suitable Fumigation Management Plan can be found inSTERIS publication (P129383-938) or searching EPA website (epa.gov) for the keywords ’Vaprox Package Insert.’ WARNING – PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD: • Lifting Biodecontamination Unit requires more than one person. The unit weighs approximately 68 lb (31 kg).• Place the Biodecontamination Unit only on flat surfaces. Various internal components are designed for operation when Unit is placed on a level, flat surface. • Ensure the Biodecontamination Unit is positioned so access to power switch and facility outlet are not restricted.• Integrated (temperature and humidity) sensors are fragile. Do not bang, twist or crush. Biodecontamination Unit does not operate properly with a damaged sensor.
3-3Operating Instructions Operator Manual 10087252Figure 3-1. VHP X10 Biodecontamination Unit in Cases4. Unlatch (all six) Biodecontamination Unit case cover and lift cover(see Figure 3-2).Figure 3-2. Open Biodecontamination Unit Case5. Open Accessories Case (see Figure 3-3) and unpack accessories:• Inlet Hose Assembly• Outlet Hose Assembly• Sash Support Plate Assembly• Exhaust Plenum Adapter• Power Cord (Either 120V or 230V).Figure 3-3. Accessory Case ComponentsMPower CordSash SupportPlate AssemblyExhaust Plenum AdapterInlet Hose Assembly Outlet HoseAssembly
3-410087252 Operator Manual Operating Instructions6. Attach Sash Plate Assembly to Enclosure.7. Attach Exhaust Plenum Adapter to Enclosure. 8. Connect hoses from VHP X10 Biodecontamination Unit toEnclosure (see Figure 3-4). Follow labels on BiodecontaminationUnit.Figure 3-4. Connect Biodecontamination Unit to Enclosure3.2.2 Prepare Enclosure andBiodecontamination UnitThe following information is intended to enable a Trained and CertifiedApplicator to properly set-up the Biodecontamination Unit and preparethe Enclosure (refer to SECTION 2.1, TERMS AND DEFINITIONS):1. Per FMP*, make all necessary preparations to Enclosure. Verify CIs and BIs are placed inside Enclosure as required.*Guidance for developing a suitable FumigationManagement Plan can be found in STERISpublication (P129383-938) or searching EPAwebsite (epa.gov) for the key words ’VaproxPackage Insert.’2. Wearing proper PPE, unpack desiccant cartridge and Vaprox 59Sterilant Cup from packaging (see Figure 3-5). 3. Ensure Sterilant Cup is not expired.4. Plug Biodecontamination Unit power cord into proper facilityoutlet (120 Vac, 20A or 230 Vac, 10A; single source circuit).5. Turn Biodecontamination Unit power ON,6. Use Arrow Keys to highlight SELECT CYCLE on display. PressStart button to continue.7. Use Arrow Keys to highlight desired cycle on display. PressStart button to continue.8. If cycle option asks, set date and time.9. If cycle option asks, select language.10. Follow screen prompt, open door and insert Sterilant Cup anddesiccant cartridge into unit (see Figure 3-5). NOTE: Refer to SECTION 6.6, STERILANT CUP INSTALLATION ANDREMOVAL, and SECTION 6.7, DESICCANT INSTALLATION ANDREMOVAL, for more information of desiccant cartridge andSterilant Cup insertion.11. Follow screen prompt, press Start.To Sash Plate Assembly To Exhaust Plenum Adapter Supply Door Fastening Screws
3-5Operating Instructions Operator Manual 10087252Figure 3-5. Open Supply Door12. Follow screen prompt, insert USB device or press Start.13. Follow display commands as cycle proceeds (refer toSECTION 6.4, BIODECONTAMINATION CYCLE).14. At completion of HOLD phase, MANDATORY AERATION (5minutes) phase starts.15. At completion of MANDATORY AERATION, if optional aeration isdesired, press Cancel. Proceed as follows:a. Control asks, USE EXTERNAL AERATOR?b. Turn Enclosure fan OFF.c. Position VHP AR60™ Aerator near Enclosure. d. Disconnect Outlet and Inlet Hose Assemblies from Biodecontamination Unit and connect to AR60 Aerator (see Figure 3-6).e. Plug AR60 Aerator into applicable wall outlet (120 or 230 Vac).f. Turn AR60 Aerator ON by pressing power switch.g. Turn Enclosure fan ON.h. Press Check button.i. Allow AR60 Aerator to operate until H2O2 is reduced to a safe level of less than or equal to 1 PPM.16. At completion of MANDATORY AERATION, if optional aeration is not desired, control continues with AERATION phase.17. Cycle completes, alarm sounds and control displaysCOMPLETE - PRESS KEY. Press Check button.18. Proceed to next section.Sterilant CupFor DesiccantCartridgeFor SterilantCupDesiccant Cartridge DANGER – CHEMICAL INJURY HAZARD: • When handling the Biodecontamination System hoses, wear appropriate PPE (refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE). Any visible liquid in the hoses must be treated as concentrated hydrogen peroxide and all hydrogen peroxide handling precautions must be observed.• The Biodecontamination Unit generates harmful hydrogen peroxide vapor and discharges it from the Outlet port. Always ensure all connections are vapor tight and that the Enclosure (refer to SECTION 2, TERMS AND DEFINITIONS) is properly sealed, secured and placarded as described on the Vaprox 59 Hydrogen Peroxide Sterilant label and package insert. Heed this Safety Precaution to ensure, under normal conditions, the Biodecontamination Unit and Enclosure do not leak H2O2 vapor.
3-610087252 Operator Manual Operating InstructionsFigure 3-6. Connecting X10 Biodecontamination Unit and AR60 Aerator to Enclosure3.2.3 Cycle CompletionThe following information is intended to enable a Trained and CertifiedApplicator to properly disconnect a X10 Biodecontamination Unit froman Enclosure (refer to SECTION 2.1, TERMS AND DEFINITIONS) afterBiodecontamination Cycle completion:1. After CYCLE COMPLETE, Enclosure may be entered per FMP.2. Remove and properly discard of used desiccant cartridge andSterilant Cup from Biodecontamination Unit.3. Disconnect hoses, move Biodecontamination Unit fromEnclosure.NOTE: Do not transport Biodecontamination Unit with SterilantCup in the Unit.4. Remove Sash Support and Exhaust Plenum Adapter fromEnclosure.5. Return Enclosure to operational status per FMP.EnclosureVHPX10VHPAR60EnclosureVHPX10VHPAR60Biodecontamination Unit Connected to EnclosureInletKEY: OutletAerator Connected to EnclosureDANGER – CHEMICAL INJURY HAZARD: • Any visible liquids in the Enclosure (refer to SECTION 2, TERMS AND DEFINITIONS) must be treated as concentrated hydrogen peroxide. Always test residual liquids, using a Liquid Hydrogen Peroxide test strip (follow manufacturer's instructions), before diluting and wiping up. Observe all hydrogen peroxide handling precautions presented in the Vaprox 59 Hydrogen Peroxide Sterilant SDS, product label and package insert. • At the end of the Aeration phase, use a low level hydrogen peroxide monitor to check and periodically monitor the hydrogen peroxide vapor concentration within the Enclosure (refer to SECTION 2, TERMS AND DEFINITIONS). The hydrogen peroxide vapor concentration should be at or below established levels before the Enclosure is accessed by Trained and Certified Applicators. The Vaprox 59 Hydrogen Peroxide Sterilant label and package insert contain required hydrogen peroxide limits for re-entry and releasing of the Enclosure after Biodecontamination
4-1Troubleshooting Operator Manual 100872524.1 Troubleshooting The VHP X10™ Biodecontamination Unit alerts the Trained andCertified Applicator of various alarm/abort situations. Alarms occuras a result of component failures, utility failures, unexpectedmeasurements from sensors or as a warning indication thatApplicator intervention is necessary (see Table 4-1 and Table 4-2). Refer to Troubleshooting Guide (Table 4-3) for description of AlarmMessage Displays.If a situation occurs that is not described in this manual, please callSTERIS Life Sciences. Trained service personnel can promptlyrestore this X10 Biodecontamination Unit to proper working order. NOTE: Never permit unqualified persons to service thisBiodecontamination Unit.IMPORTANT: A listing of the SAFETY PRECAUTIONS to be observed when operating and servicing thisequipment and/or handling Vaprox 59 Hydrogen Peroxide Sterilant can be found in SECTION 1 of thismanual. Do not operate or service the equipment or handle the Sterilant until you have been trainedand certified on this information as well as the information on the Vaprox 59 Hydrogen PeroxideSterilant product label and package insert.DANGER – PERSONAL INJURY, CONTAMINATED ENCLOSURE AND/OR EQUIPMENT DAMAGE HAZARD: No one may enter a sealed Enclosure during or after an aborted cycle without SCBA and appropriate PPE (refer to Sterilant SDS for PPE) if Sterilant levels within the treated Enclosure are above one PPM. Refer to Sterilant label and package insert for instructions.WARNING – PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD: Integrated (temperature and humidity) sensors are fragile. Do not bang, twist or crush. Biodecontamination Unit does not operate properly with a damaged sensor. Table 4-1. Alarm/Abort ActionsPhase at Alarm-Abort Action FollowingAlarm-AbortBefore start of Sterilant Injection phase (before Condition/Biodecontamination)Advance to Cycle CompleteDuring Sterilant injection (Condition/Biodecontamination)Advance to AerationTable 4-2. Power Interruption/Power-Up Actions Active Cycle Phase Action Upon Power ReturnHeat Cabinet Abort CycleDehumidify Abort CycleRe-Heat Cabinet Abort CycleHeater Cap Warm-Up Abort CycleCondition AerationBiodecontamination AerationAeration Restart AerationCycle Complete Return to Cycle CompleteTROUBLESHOOTING 4
4-210087252 Operator Manual TroubleshootingroupTable 4-3. Troubleshooting GuideAlarm Message Display Description Possible Causes and / or Corrections1. Power Lost Occurs after the X10 BU has experienced a loss of power• System Initiated: NA2. Door Open Occurs when the safety interlock key is not inserted in the safety interlock switch• Door not completely closed at beginning ofcycle – Close Door• Safety interlock switch failure or wiringdisconnected/shorted.• Contact STERIS.3. Door Interlock Fail Occurs at any time during a cycle and after the dehumidify phase, the safety door interlock coil remains energized• Safety interlock switch failure or wiringdisconnected/shorted.• Contact STERIS.4. Datalog Save Fail Occurs while attempting to save a datalog file to a USB Flash memory stick• Verify that a USB Flash memory stick isinserted in the USB port. • Attempt the save operation while using adifferent USB Flash memory stick.5. Heater Cap RTD Fail Occurs when the heater cap RTD (RTD1) temperature reading indicates a break or short in the wiring or the reading is at an extreme high or low for 10 seconds continuously• Sensor failure or wiring disconnected/shorted. • Analog channel failure.• Contact STERIS.6. Htr Cp Too Long Heat Occurs during the heating (heater cap) phase (prior to Condition or Biodecontamination), the heater cap temperature fails to reach the setpoint temperature within 15 minutes• Improper in-cycle heater cap temperaturesetpoint. • RTD1/Control board/Wiring failure. • RTD1 failure.• AC Control Board/Solid State relay (SSR2)failure.• Contact STERIS.7. Heater Cap Temp DevOccurs during the Condition or Biodecontamination phase, the heater cap RTD1 temperature reading is 86°F (30°C) above or below the programmed setpoint temperature for two seconds continuously• Pre-heater temperature too low.• RTD1/Control Board/Wiring failure.• Improper in-cycle heater cap temperaturesetpoint.• Contact STERIS.8. Heater Cap OvertempOccurs at any time, the heater cap over-temperature switch (SW2) has tripped• RTD1 failure.• Solid State relay (SSR2) failure.• RTD1/Control Board/Wiring failure whenheater cap is cool.• Contact STERIS.
4-3Troubleshooting Operator Manual 100872529. Cabinet Temp RTD FailOccurs at any time, the Airflow RTD (RTD2) temperature reading indicates a break or short in the wiring or the reading is at an extreme high or low, for 10 seconds continuously• Sensor failure or wiring disconnected/shorted: Check RTD2 connector andconnector on control board. Repair asneeded or replace RTD.• Control Board failure: Replace controlboard.10. Cabinet Too Long HeatOccurs during the heating (cabinet) phase (prior to Condition or Biodecontamination), and after 15 minutes of operation, the Cabinet Temperature does not increase 0.1°C over a 5 minute period• Improper cabinet heater temperaturesetpoint: Verify temperature setpoint.Setpoint should be approximately 31°C.• RTD2/Control Board/Wiring failure: Verifyproper operation of cabinet heater controlcircuit.• RTD2 failure: Calibrate or replace.• Solid State relay (SSR2) failure: Replace.11. RH Sensor Failure Occurs at any time, the airflow RH (RH1) reading indicates a break or short in the wiring for 10 seconds continuously• Sensor failure or wiring disconnected/shorted: Check the RH1 connector andconnector on the control board. Repair asneeded or replace RH probe or board.• Control Board failure: Replace controlboard.12. Dehumidify Timeout Occurs during the dehumidify phase, the RH sensor fails to reach the setpoint within 80 minutes• Desiccant is saturated: Replace desiccant.• Blower failure: Verify movement of air. SeeAlarm Message 14.• RH Sensor/Control Board/Wiring failure:Verify proper operation of RH control circuit.• RH Sensor failure: Calibrate or replace.• Enclosure too large for dryer type: Increasedryer capacity.13. Blower Airflow Dev Occurs during any cycle phase, the cycle flow blower (MTR-1) control output has exceeded its upper or lower limit for two minutes continuously• Air inlet blocked: Verify proper air flowthrough X10 unit.• MTR-1/Control Board/wiring failure: Verifyproper operation of blower control circuit.• Solid State Relay (SSR1) failure: Replace.14. Circ Blower Failure Occurs during any cycle phase where the circulation blower option is ON and the blower does not run• MTR-1/Control Board/wiring failure: Verifyproper operation of blower control circuit.• Solid State Relay (SSR1) failure: Replace.15. Operator Abort Occurs at any time, when the Operator requests an abort during a cycle• Operator initiated: Not applicableTable 4-3. Troubleshooting Guide (Cont’d)Alarm Message Display Description Possible Causes and / or Corrections
4-410087252 Operator Manual Troubleshooting16. External Aerator Fail Occurs when the External Aerator option is ON and the External Aerator input is open.• Auxillary Aerator Unit unplugged from Unit:Connect Auxillary Aerator Unit.• External Aerator option inadvertentlyselected: Deselect this option in the menu.17. Sterilant Cup ExpiredOccurs during the reading of the sterilant cup RFID tag, the sterilant cup expiration date is past the current calendar date• Replace the sterilant cup with one that isnot expired.• Check the sterilant cup's printed expirationdate.• Check that the BU system date is correct.18. Sterilant Cup Used Occurs during the reading of the sterilant cup RFID tag, the sterilant cup serial number matches a previously used code• Replace the sterilant cup with one that hasnot been used.19. Sterilant Cup Bad SKUOccurs during the reading of the sterilant cup RFID tag, the sterilant cup SKU code does not match the BSC system SKU code• Replace the sterilant cup with one that hasthe correct SKU.• Check the sterilant cup's printed SKU code.20. Sterilant Cup Bad WrtOccurs during the condition phase, the writing of the sterilant cup RFID tag, and subsequent verification reading, the RFID tag's serial number does not contain the used cup code• Manually mark the cup as used.• Verify the proper operation of the RFIDReader/Writer.21. RH Sensor Not CalibAppears at any time the RH Sensor's Relative Humidity input is identified as not calibrated• System initiated: Not applicable.22. RH RTD Not Calib Appears at any time the RH Sensor's RTD input is identified as not calibrated• System initiated: Not applicable.23. Machine Calib Due Occurs any time calibration is due for the BSC Unit analog inputs or outputs• System initiated: Not applicable.24. Drum Assembly Index FailOccurs at any time the drum assembly does not encounter one of the three indexer sensors• Check sensors on the drum position board.• Check the drum indexing motor (MTR-2).• Verify proper torque on rear drum assemblyretaining bolt.25. Control Board Fail Occurs at any time a Control Board fault is issued by the Control Board•TBD.* STERIS Life SciencesTable 4-3. Troubleshooting Guide (Cont’d)Alarm Message Display Description Possible Causes and / or Corrections
5-1Routine Maintenance Operator Manual 100872525.1 Read BeforePerforming RoutineMaintenanceThe routine maintenance procedures described in this section of themanual should be performed whenever necessary. Any maintenanceprocedures not included in this section should be performed only bySTERIS Life Sciences Service or STERIS-trained service personnelfully acquainted with the equipment.In addition to the routine maintenance described in this section,regularly scheduled preventive maintenance is essential for safe andreliable operation of the equipment. Annual maintenance agreementsare available to provide scheduled maintenance, adjustments andreplacement of worn parts performed by a qualified technician, tohelp ensure peak equipment performance and help avoidunscheduled downtime. Contact STERIS Life Sciences for details.Maintain a record of all maintenance procedures performed on theVHP X10™ Biodecontamination Unit. If a problem occurs, refer toSECTION 4, TROUBLESHOOTING, or contact STERIS Life Sciences.NOTE: Never permit unqualified persons to service this equipment.WARNING – PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD: • Repairs and adjustments to this equipment must be made only by STERIS Life Sciences or STERIS-trained service personnel. Maintenance performed by unqualified personnel or installation of unauthorized parts could cause personal injury, result in improper equipment performance, invalidate the warranty or result in costly damage. Contact STERIS Life Sciences regarding service options.• Regularly scheduled preventive maintenance is required for safe and reliable operation of this equipment. Contact STERIS Life Sciences to schedule preventive maintenance.ROUTINE MAINTENANCE 5
5-210087252 Operator Manual Routine Maintenance5.2 CleanBiodecontaminationUnitSTERIS Life Sciences recommends cleaning the outside surfaces ofthe VHP X10 Biodecontamination Unit with a mild detergent solution(such as Liqui-Jet™ 2 Instrument Detergent). Clean the Biodecontamination Unit as follows:1. Unplug unit.2. Apply cleaning solution with a damp cloth, rubbing in back and forth motion.NOTE: Avoid getting solution into the controls. Wring out cloth before wiping the control panel.3. Rinse cloth and wipe off any detergent residue.4. Dry surfaces with clean, lint-free cloth.NOTE: Should it become necessary to sterilize or disinfect theoutside plastic VHP X10 Biodecontamination Unit surfaces beforeentering an Enclosure, STERIS Life Sciences recommends Spor-Klenz® Ready-To-Use Cold Sterilant. This sterilant is a liquidsporicide specifically formulated for sterilization and disinfection ofhard surfaces.CAUTION – POSSIBLE EQUIPMENT DAMAGE: Use nonabrasive cleaners when cleaning Biodecontamination Unit. If you need technical assistance or additional instructions, call STERIS Life Sciences.• Follow all directions on container. • Do not use abrasive cleaners on plastic surfaces. • Avoid detergents with bases, aromatics, ketones, esters and chlorinated hydrocarbons.• Avoid contacting plastic surfaces with greases and oils.
5-3Routine Maintenance Operator Manual 100872525.3 Clean Hoses NOTE: Condensation inside the hoses must be assumed to beconcentrated hydrogen peroxide (H2O2). Review the DANGERS,WARNINGS and CAUTIONS located below and in SECTION 1,SAFETY PRECAUTIONS, of this manual before handling the hoses.Also, read and comply with the Safety Precautions outlined on theVaprox® 59 Hydrogen Peroxide Sterilant MSDS and the Vaprox 59Hydrogen Peroxide Sterilant product label and package insert.The Sterilant delivery hoses must be cleaned periodically to removedust and other debris from the interior surfaces. Clean the hosesannually, or whenever the interior of the hoses becomes soiled ordusty.Clean hose interiors as follows:1. Put on PPE (refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE).DANGER – FIRE AND EXPLOSION HAZARD: Liquid hydrogen peroxide is a strong oxidant and poses a FIRE, EXPLOSION OR CONTAINER RUPTURE HAZARD. Avoid excessive heat, contamination or contact with combustible materials. Clothing, shoes or other combustible materials that have come in contact with hydrogen peroxide must be immediately and thoroughly washed with water. Discard shoes contaminated with Vaprox sterilant in a fireproof container. If Vaprox 59 Hydrogen Peroxide Sterilant is allowed to dry in the materials, a fire may result. IN CASE OF FIRE, use water only. CONTAIN SPILLS and dilute with water (at least 20 parts water to one part H2O2). After diluting the spill, sodium metabisulfide or sodium sulfite (1.9 lb of SO2 equivalent per 500 mL of H2O2) may be used to destroy the peroxide. SEE MSDS FOR ADDITIONAL INFORMATION. EFFECTS MAY BE DELAYED.DANGER – SLIPPING HAZARD: Water or hydrogen peroxide spilled on the floor presents a slipping hazard – promptly clean up the spill. If in doubt whether the liquid is water or hydrogen peroxide, test the liquid using a Liquid Hydrogen Peroxide Test Strip (follow manufacturer's instructions), before wiping up. If the liquid is hydrogen peroxide, contain the spill and dilute with water (at least 20 parts water to one part H2O2) prior to wiping up. Observe all hydrogen peroxide handling precautions. Refer to the Vaprox 59 Hydrogen Peroxide Sterilant SDS for spill containment and cleanup.DANGER – CHEMICAL INJURY HAZARD: • CORROSIVE. Causes irreversible eye damage or skin burns. May be fatal if inhaled. Harmful if swallowed or absorbed through the skin. Do not get in eyes, on skin or on clothing. Do not breathe spray mist. Prolonged or frequently repeated skin contact may cause allergic reaction in some individuals. User should wash hands before eating, drinking, chewing gum, using tobacco or using the toilet. User should remove contaminated clothing and wash before reuse. Applicators and all other handlers must wear PPE (refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE). See Vaprox Hydrogen Peroxide Sterilant or Vaprox 59 Hydrogen Peroxide Sterilant product label and package insert for additional handling information.• When handling the Biodecontamination System hoses, wear appropriate Personal Protective Equipment (refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE). Any visible liquid in the hoses must be treated as concentrated hydrogen peroxide and all hydrogen peroxide handling precautions must be observed.• When handling hydrogen peroxide, wear appropriate PPE (refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE) and observe all Safety Precautions. See Vaprox 59 Hydrogen Peroxide Sterilant MSDS, product label and package insert for additional handling information.
5-410087252 Operator Manual Routine Maintenance2. Remove or disconnect hoses from Enclosure (refer to SECTION 2.1, TERMS AND DEFINITIONS) and/or Biodecontamination Unit.NOTE: Sterilant delivery hoses should not be left lying aroundwhere they can be contaminated with dust or other particles whichmay catalyze the decomposition of the Sterilant. Hoses should bedisconnected from the VHP X10 Biodecontamination Unit andstored when not connected to an Enclosure.3. Submerge hoses in a clean sink or tub filled with water containing a mild detergent.4. Soak hoses for 30 minutes, then drain the sink or tub.5. Thoroughly rinse hoses with distilled water.6. Dry hoses by blowing oil-free, filtered, compressed air through them, or allow hoses to air dry.7. Return hoses to their original position when dry.5.4 Cleaning TouchScreenThe VHP X10 Biodecontamination Unit is controlled by a PLC. Cleanthe touch screen at regular intervals (at least once a week) as follows:1. Ensure Biodecontamination Unit power is OFF.2. Using water with detergent, screen cleaning agent or alcohol (Ethanol), dampen a clean cloth. Do NOT spray fluid directly on screen.3. Gently wipe screen.4. Dry with clean, lint-free cloth.5.5 Replacement Partsand SuppliesUse only STERIS-authorized parts on this equipment. Use ofunauthorized parts will void the warranty. 5.5.1 Ordering Information To order replacement parts and/or supply products, proceed asfollows: 1. Include the part number and description as listed in SECTION 5.5.2, SUPPLY PRODUCTS and SECTION 5.5.3, RECOMMENDED SPARE PARTS.2. Include the model and serial numbers of your equipment on your order.3. Send your order directly to the STERIS Life Sciences Representative serving your area.Contact STERIS Life Sciences* if you need parts that are not listed inthis manual.*1 (800) 440-9009 or www.sterislifesciences.com.WARNING – PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD: Repairs and adjustments to this equipment must be made only by STERIS Life Sciences or STERIS-trained service personnel. Maintenance performed by unqualified personnel or installation of unauthorized parts could cause personal injury, result in improper equipment performance, invalidate the warranty or result in costly damage. Contact STERIS Life Sciences regarding service options.
5-5Routine Maintenance Operator Manual 100872525.5.2 Supply Products NOTE: Use only STERIS U.S. EPA-registered Vaprox 59 HydrogenPeroxide Sterilant in STERIS Containers. Vaprox Containers containhigh purity 59% hydrogen peroxide and are filled under controlledconditions to ensure effectiveness through the expiration date stampedon the label. Federal law requires that the sterilant be registered withthe U.S. EPA. Use of unregistered sterilant is prohibited and a violationof Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) federallaw and will void the warranty. 5.5.3 Recommended SparePartsThe parts listed in this section are those that are necessary to repairthe VHP X10 Biodecontamination Unit in most instances.DANGER – PERSONAL INJURY, CONTAMINATED ENCLOSURE AND/OR EQUIPMENT DAMAGE HAZARD: Use only Vaprox 59 Hydrogen Peroxide Sterilant Containers, containing STERIS-registered hydrogen peroxide which has been specially formulated, tested and approved for use in this X10 Biodecontamination Unit. Vaprox 59 Hydrogen Peroxide Sterilant has been registered by STERIS in accordance with U.S. Federal Regulations for the specific uses described in this manual. Use of other materials and/or H2O2 other than Vaprox 59 H2O2 Sterilant could impair equipment operation, result in costly repairs, result in an ineffective Biodecontamination Cycle, violate federal law and void the equipment warranty.Table 5-1. VHP X10 Biodecontamination Unit Selected Supply ProductsDescription Part NumberVaprox 59 Hydrogen Peroxide Sterilant(EPA Reg. No. 1043-123); 4 x 70 mLPB034USVHP X10 Desiccant Cartridge) 10032310Spor-Klenz Ready-To-Use Cold Sterilant (1 qt. - 4 per case)6525M2Liqui-Jet 2 Instrument Detergent (1 gal) 103708Table 5-2. Recommended Spare PartsDescription Part Number QuantityBATTERY, Main Control Board, 3 V (CR2477) 2CORD, Power, 230 Vac 10035152 1CORD, Power, 120 Vac 10035151 1CUP, Vaprox 59 Hydrogen Peroxide Sterilant (EPA Reg. No. 1043-123, 70 mL) PB034 1DESICCANT TBD 1FERRULE, Flangeless Tubing P387349-031 10FILTER, Injection 10015443 2FUSE, Blower, 4 A 10037461 2FUSE, Blower, 4 A ((For 120 Vac Unit) 10017002 2FUSE, Blower, 2 A (For 230 Vac Unit) 10034820 2FUSE, Heater, 10 A (For 120 Vac Unit) 10017003 2
5-610087252 Operator Manual Routine Maintenance5.6 AssociatedPublicationsPublications listed in this section are those associated with the useand maintenance of this VHP X10 Biodecontamination Unit.When ordering, please include the part number (if applicable),description and quantity of each publication requested. Order directlyfrom STERIS Life Sciences Representative.FUSE, Heater, 5 A (For 230 Vac Unit) 10017003 2HARNESS, Amber Light 10020036 1HOSE ASSEMBLY, 2” Cam Lever 10038131 5 ftHOSE ASSEMBLY, 2” Cam Lever 10038130 10 ftNUT, Tubing P387349-030 10TUBE, Draw 10014998 1Table 5-2. Recommended Spare Parts (Cont’d)Description Part Number QuantityTable 5-3. Associated PublicationsDescription Part NumberTech Data Sheet SD997Uncrating/Installation Instructions 10037273Equipment Drawings 10105142Maintenance Manual P764335-550
6-1Supplemental Information Operator Manual100872526.1 InstallationVerificationAn equipment drawing, showing all utility and space requirements, issupplied when the X10™ Biodecontamination Unit is ordered. Anyclearance space specified on the equipment drawing is necessary forproper operation, maintenance and repair of the system components.Uncrating/Installation Instructions were furnished with the X10Biodecontamination Unit. If these documents are missing or misplaced,contact STERIS Life Sciences, giving the serial, equipment and modelnumbers of the unit. Replacement copies will be sent to you promptly. NOTE: Do not use Unit in an area not compatible with oxidizers.6.1.1 InstallationChecklistAfter installing and connecting (refer to Figure 3-6) the X10 Biodecontamination Unit on a hard level surface according to the instructions provided, complete the following checklist to ensure the installation is complete and correct. Contact STERIS Life Sciences to schedule a demonstration of proper equipment operation.❑Unplug system before servicing.❑Electric service to the system components must be as specifiedon the component data plates and equipment drawings.❑Electric service should be on a separate circuit, and not tied intocircuits containing large reactive loads (e.g., motors).❑Electric service must provide a protective earth ground asspecified by the local codes for an industrial circuit.❑Extension cord use is not recommended.6.1.2 Pre-OperationChecklistRead all Safety Precautions in SECTION 1, SAFETY PRECAUTIONS, before operating the equipment. Then complete the following checklist before operating the X10 Biodecontamination Unit.Check that:❑The hoses (with appropriate connectors) properly connect theBiodecontamination Unit to the Enclosure (refer to SECTION 2.1,TERMS AND DEFINITIONS) or other system components as describedin SECTION 3.2, OPERATION.❑A hydrogen peroxide detection monitor or vapor tubes must beavailable to test for Enclosure (refer to SECTION 2.1, TERMS ANDDEFINITIONS) leakage.REMEMBER – POSSIBLE TIME DELAY: Insufficient clearance space will make repairs more difficult and time-consuming. Refer to the equipment drawing for minimum clearance for service/maintenance access requirements.DANGER – CHEMICAL INJURY HAZARD: When handling hydrogen peroxide, wear appropriate PPE (refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE) and observe all Safety Precautions. See Vaprox 59 Hydrogen Peroxide Sterilant SDS, product label and package insert for additional handling information.WARNING – PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD: • Lifting the Biodecontamination Unit requires more than one person. The unit weighs approximately 65 lb (30 kg).• Park Biodecontamination Unit only on flat surfaces. The caster brakes are not designed to maintain the unit stationary on inclined surfaces. In addition, various internal components are designed for operation when unit is parked on a level, flat surface.• Integrated (temperature and humidity) sensors are fragile. Do not bang, twist or crush. Biodecontamination Unit does not operate properly with a damaged sensor. SUPPLEMENTAL INFORMATION 6
6-210087252 Operator ManualSupplemental Information❑Biodecontamination Unit components are properly positioned inrelation to Enclosure (refer to SECTION 2.1, TERMS AND DEFINITIONS)being processed, as described in SECTION 3.2, OPERATION.❑The X10 Biodecontamination Unit components are properlyconnected (refer to Figure 3-4 or Figure 3-6).❑A Vaprox® 59 Hydrogen Peroxide Sterilant Cup is in place; if aCup is not in place or is empty, install a new Cup as described inSECTION 6.6, STERILANT CUP INSTALLATION AND REMOVAL.❑Desiccant cartridge assembly is properly inserted (seeSECTION 6.7, DESICCANT INSTALLATION AND REMOVAL).6.2 Technical Data6.2.1 Overall Size (W x H x D) 28 x 22 x 15" (711 x 559 x 381 mm)6.2.2 Weight 68 lb (31 kg)6.2.3 Electric Requirements 120 Vac, 50/60 Hz, 12 A, 1 Ph 230 Vac, 50/60 Hz, 7 A, 1 Ph 6.2.4 EnvironmentalConditionsTemperature: 60 to 104°F (16 to 40°C)Maximum Humidity: 70% A-Weighted Sound Power Level: 73 dBA (mean) - 83 dBA (maximum); use earplugs.Pollution Degree: 2Installation Category (Overvoltage Category): IIIP67 Rating Closed; IP20 Rating OpenIC Number: IC:11700A-VHPX10IC Statement:This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.FCC Number: 2ABQIVHPX10.FCC Statement:This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.NOTE: This equipment has been tested and found to comply with thelimits for a Class A digital device, pursuant to part 15 of the FCC Rules.These limits are designed to provide reasonable protection againstharmful interference when the equipment is operated in a commercialenvironment. This equipment generates, uses, and can radiate radiofrequency energy and, if not installed and used in accordance with theinstruction manual, may cause harmful interference to radiocommunications. Operation of this equipment in a residential area islikely to cause harmful interference in which case the user will berequired to correct interference at his own expense.
6-3Supplemental Information Operator Manual100872526.3 Hydrogen PeroxideBiodecontaminationFigure 6-1. X10 Biodecontamination UnitThe X10 Biodecontamination Unit (see Figure 6-1) provides a simple and reliable method for Biodecontaminating pre-cleaned, dry sealable Enclosures (refer to SECTION 2.1, TERMS AND DEFINITIONS).Effective use of H2O2 vapor for Biodecontamination requires adequate concentration and exposure time.The X10 Biodecontamination Unit typically uses a closed loop process(refer to SECTION 3, OPERATING INSTRUCTIONS) utilizing air as a carrierto deliver Vaprox 59 Hydrogen Peroxide Sterilant vapor to theexposed surfaces inside a pre-cleaned, dry, sealed Enclosure (referto SECTION 2.1, TERMS AND DEFINITIONS). This closed loop processallows the Biodecontamination process to take place at atmosphericconditions. Because Biodecontamination relies only on the contact ofSterilant with exposed surfaces, the transfer of heat and moisturerequired by steam processes is not necessary.H2O2 vapor is continuously injected for the required exposure time toachieve Biodecontamination. The Sterilant evacuated from theEnclosure in a closed loop operation is catalytically converted intowater vapor and oxygen. .6.4 BiodecontaminationCycleThe properly installed X10 Biodecontamination Unit outside theEnclosure (refer to SECTION 2.1, TERMS AND DEFINITIONS) uses STERIS’sVHP® process technology. This process uses hydrogen peroxide vaporas a broad-spectrum antimicrobial without condensation of activeingredient onto surfaces. This non-condensation feature providesadditional benefit of a wide range of material compatibility. In practice, an aqueous solution of 59% (Vaprox 59 Hydrogen PeroxideSterilant) hydrogen peroxide vapor is atomized and a high velocity airstream disperses it throughout Enclosure. Relative humidity andtemperature sensor measurements ensure the vapor does not condenseon internal Enclosure surfaces.NOTE: Refer to the Vaprox 59 Hydrogen Peroxide Sterilant packagelabel for additional information and Application instructions.DANGER – PERSONAL INJURY, CONTAMINATED ENCLOSURE AND/OR EQUIPMENT DAMAGE HAZARD: Use only Vaprox 59 Hydrogen Peroxide Sterilant Cups, containing STERIS-registered hydrogen peroxide which has been specially formulated, tested and approved for use in this X10 Biodecontamination Unit. Vaprox 59 Hydrogen Peroxide Sterilant has been registered by STERIS in accordance with U.S. Federal Regulations for the specific uses described in this manual. Use of other materials and/or H2O2 other than Vaprox 59 H2O2 could impair equipment operation, result in costly repairs, result in an ineffective Biodecontamination Cycle, violate federal law and void the equipment warranty.
6-410087252 Operator ManualSupplemental InformationThe Biodecontamination Cycle (see Figure 6-2) proceeds as follows:1. Biodecontamination Unit display prompts Trained and CertifiedApplicator to insert Vaprox 59 Hydrogen Peroxide Sterilant Cup anddesiccant cartridge (see SECTION 6.6, STERILANT CUP INSTALLATIONAND REMOVAL and SECTION 6.7, DESICCANT INSTALLATION ANDREMOVAL). 2. Display prompts user to press START. NOTE: After starting the cycle, the Trained and Certified Applicatorhas time to safely finalize any sealing per FMP prior to Conditionand Biodecontamination phases.3. Biodecontamination Unit performs a system check on Sterilant Cup.4. Upon successful check, Biodecontamination Unit begins Pre-Heat Cabinet phase. 5. After pre-heating cabinet to 88°F (31°C), Dehumidification phase starts and air circulates through desiccant to dehumidify Enclosure to 15% RH. NOTE: During this time the liquid Sterilant is primed into theinjection lines (approximately two minutes for priming).6. After 15% RH setpoint is reached, Enclosure is heated to 88°F (31°C).7. Once setpoint is reached, heater cap is heated to set value.8. Condition phase (Sterilant injection) begins. Biodecontamination Unit generates hydrogen peroxide vapor and circulates Sterilant throughout Enclosure at set injection rate to build concentration to > 400 PPM.9. Biodecontamination phase follows for preset time. Biodecontamination Unit continues to circulate hydrogen peroxide vapor at a lower injection rate to achieve desired bioburden targets.Figure 6-2. Typical Biodecontamination Cycle KE- - - - - - - - - - - Gas Concentration ._._._._._ Relative Humidity Condensation PointLessDehumidifyConditionBiodecontaminationAerationMoreLessMoreVHP Concentration Relative Humidity Condensation Point
6-5Supplemental Information Operator Manual1008725210. At completion of Biodecontamination phase, Biodecontamination Unit enters a Hold phase to recirculate Sterilant vapor for set time (no injection or heat). 11. Injection lines are purged of any liquid back into Vaprox 59 Hydrogen Peroxide Sterilant Cup (approximately three minutes for purging).12. At Hold phase completion, Biodecontamination Unit advances to Aeration phase for pre-determined time. 13. Air passes through catalyst until Sterilant concentration is reduced to 1 ppm.14. Cycle Complete phase begins. Biodecontamination Unit turns blower OFF and saves cycle data to USB.6.5 Hydrogen PeroxideHandling PrecautionsCertain precautions must be observed when handling hydrogenperoxide (H2O2). Review the Safety Precautions located in SECTION 1of this manual before handling the Vaprox 59 Hydrogen PeroxideSterilant Cups. Also, read, comply with and save the Sterilant SDS andVaprox 59 Hydrogen Peroxide Sterilant Cups label and package insert. DANGER – PERSONAL INJURY, CONTAMINATED ENCLOSURE AND/OR EQUIPMENT DAMAGE HAZARD: • Use only Vaprox 59 Hydrogen Peroxide Sterilant Containers, containing STERIS-registered hydrogen peroxide which has been specially formulated, tested and approved for use in this X10 Biodecontamination Unit. Vaprox 59 Hydrogen Peroxide Sterilant has been registered by STERIS in accordance with U.S. Federal Regulations for the specific uses described in this manual. Use of other materials and/or H2O2 other than Vaprox 59 Hydrogen Peroxide Sterilant could impair equipment operation, result in costly repairs, result in an ineffective Biodecontamination Cycle, violate federal law and void the equipment warranty.• Before using Vaprox 59 Hydrogen Peroxide Sterilant Cup, check the expiration date. Do not use Sterilant if it is beyond its expiration date, or if it will not be fully used before its expiration date.• Before disposing of a Vaprox 59 Hydrogen Peroxide Sterilant Cup, empty all remaining Cup contents into a sink with running water (at least 20 parts water to one part Vaprox H2O2), then carefully triple rinse the Cup with tap water.DANGER – CHEMICAL INJURY HAZARD: • CORROSIVE. Causes irreversible eye damage or skin burns. May be fatal if inhaled. Harmful if swallowed or absorbed through the skin. Do not get in eyes, on skin or on clothing. Do not breathe spray mist. Prolonged or frequently repeated skin contact may cause allergic reaction in some individuals. User should wash hands before eating, drinking, chewing gum, using tobacco or using the toilet. User should remove contaminated clothing and wash before reuse. Applicators and all other handlers must wear PPE (refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE). See Vaprox 59 Hydrogen Peroxide Sterilant product label and package insert for additional handling information.• When handling the Biodecontamination System hoses, wear appropriate PPE (refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE). Any visible liquid in the hoses must be treated as concentrated hydrogen peroxide and all hydrogen peroxide handling precautions must be observed.
6-610087252 Operator ManualSupplemental Information6.6 Sterilant CupInstallation andRemovalReview SECTION 6.5, HYDROGEN PEROXIDE HANDLING PRECAUTIONS,before proceeding. The X10 Biodecontamination Unit uses Vaprox 59Hydrogen Peroxide Sterilant in Cups (see FIGURE 6-3). Figure 6-3. Typical Sterilant CupDANGER – FIRE AND EXPLOSION HAZARD: • Liquid hydrogen peroxide is a strong oxidant and poses a FIRE, EXPLOSION OR CONTAINER RUPTURE HAZARD. Avoid excessive heat, contamination or contact with combustible materials. Clothing, shoes or other combustible materials that have come in contact with hydrogen peroxide must be immediately and thoroughly washed with water. Discard shoes contaminated with Vaprox 59 Hydrogen Peroxide Sterilant in a fireproof container. If Vaprox Sterilant is allowed to dry in the materials, a fire may result. IN CASE OF FIRE, use water only. CONTAIN SPILLS and dilute with water (at least 20 parts water to one part H2O2). After diluting the spill, sodium metabisulfide or sodium sulfite (1.9 lb of SO2 equivalent per 500 mL of H2O2) may be used to destroy the peroxide. SEE SAFETY DATA SHEET (SDS) FOR ADDITIONAL INFORMATION. EFFECTS MAY BE DELAYED.• Verify all materials coming in contact with hydrogen peroxide, especially the concentrated liquid, are compatible with oxidizers. Contact STERIS Life Sciences or the material manufacturer for information on material compatibility.DANGER – SLIPPING HAZARD: Water or hydrogen peroxide spilled on the floor presents a slipping hazard – promptly clean up the spill. If in doubt whether the liquid is water or hydrogen peroxide, test the liquid using a Liquid Hydrogen Peroxide Test Strip (follow manufacturer's instructions), before wiping up. If the liquid is hydrogen peroxide, contain the spill and dilute with water (at least 20 parts water to one part H2O2) prior to wiping up. Observe all hydrogen peroxide handling precautions. Refer to the Vaprox 59 Hydrogen Peroxide Sterilant SDS for spill containment and cleanup.DANGER – PERSONAL INJURY,CONTAMINATED ENCLOSUREAND/OR EQUIPMENT DAMAGEHAZARD: Before starting acycle, check Sterilant to ensureit is not expired.Data Matrix Code,Lot Number,Expiration Date
6-7Supplemental Information Operator Manual100872526.6.1 Cup Installation Install Vaprox 59 Hydrogen Peroxide Sterilant Cup (see FIGURE 6-3) as follows:1. Wearing proper PPE, unpack desiccant cartridge and Vaprox 59 Sterilant Cup from packaging (refer to FIGURE 3-5).2. Check Cup expiration date. Do not use Cup if beyond expiration date listed on label (Figure 6-3).3. Turn Biodecontamination Unit power ON, open supply door.4. Gently grasp Cup and place in Biodecontamination Unit (see Figure 6-4).5. Carefully insert Cup draw tube into Cup (see Figure 6-5).6. Close supply door and lock.Figure 6-4. Sterilant Cup in Biodecontamination Unit (Typical)Figure 6-5. Carefully Insert Draw Tube (Typical)6.6.2 Cup RemovalWhen the Cycle is complete or if the X10 Biodecontamination Unit is tobe transported, the Cup must be removed. Proceed as follows:1. Put on PPE (refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE).
6-810087252 Operator ManualSupplemental Information2. Gently grasp Cup and draw tube with both hands. Carefully lift Cup and draw tube from Biodecontamination Unit.3. Dispose of Sterilant as directed in next section.NOTE: For Cups, note the following:1) If Cup in the Biodecontamination Unit is past the expiration date,remove the Cup, dispose of contents as instructed in the nextSection (SECTION 6.6.3, DISPOSAL OF STERILANT FROM CUP).2) Before transporting the Biodecontamination Unit, the SterilantCup must be removed from Biodecontamination Unit.6.6.3 Disposal of SterilantFrom CupIf the Cup is empty, does not contain enough H2O2 for any furtherBiodecontamination Cycles or the Biodecontamination Unit needstransported, proceed as follows:1. Put on PPE (refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE). Refer also to Vaprox 59 Hydrogen Peroxide Sterilant label or package insert.2. Empty all remaining Cup contents into a sink with running water (at least 20 parts water to one part H2O2).3. When Cup is empty, carefully and thoroughly triple rinse Cup with tap water before disposal.4. Properly dispose of empty Cup. 5. Rinse draw tube with water and set safely aside.6.7 DesiccantInstallation andRemovalThe X10 Biodecontamination Unit uses desiccant cartridges to convert the Sterilant into water vapor and oxygen. Install and remove desiccant cartridge as follows:1. If not already unpacked, wearing proper PPE, unpack desiccant cartridge (see Figure 6-6) and Vaprox 59 Sterilant Cup from packaging (refer to Figure 3-5).2. Turn Biodecontamination Unit power ON, open supply door by turning fastening screws (quarter turn).3. Lift latch on desiccant door and place desiccant cartridge inside (see Figure 6-7).Figure 6-6. Desiccant Cartridge (Typical)
6-9Supplemental Information Operator Manual10087252Figure 6-7. Place Desiccant Cartridge in Biodecontamination Unit 6.8 SterilantContainer StorageVaprox 59 Hydrogen Peroxide Sterilant Cups are warranted throughthe expiration date (see Figure 6-3) when the following storagepractices are followed:• Store Cups in an upright (vertical) position.• Store Containers at room temperature, not to exceed 77°F(25°C). DO NOT FREEZE.Shelf life of UNOPENED Vaprox 59 Hydrogen Peroxide Sterilant Cup is one year.Shelf life of OPENED Cup installed in the X10 Biodecontamination Unit is 45 days. However, Cup must not remain in Biodecontamination Unit when being transported.6.9 GeneralComponentIdentificationThe X10 Biodecontamination Unit is designed for mobile Biodecontamination of clean, dry, sealed Enclosures (refer to SECTION 2.1, TERMS AND DEFINITIONS) of three, four, five and six foot widths with corresponding internal volumes from 15.6 - 31.2 ft3 (.44 - .88 m3) using STERIS’s patented VHP® Process Technology and using Vaprox 59 Hydrogen Peroxide Sterilant.NOTE: The X10 Biodecontamination Unit is to be used by Trained andCertified Applicators who have successfully completed both theSTERIS Training and Certification Course for Applicators of VaproxHydrogen Peroxide Sterilant and the X10 Biodecontamination UnitOperator Course. Certification must be active and in force for allApplicators of Vaprox 59 Hydrogen Peroxide Sterilant.Before operating the X10 Biodecontamination Unit, become familiar with the location and function of all major components and controls presented in this section (see FIGURE 6-8). Refer to SECTION 2.1, TERMS AND DEFINITIONS.1. Power Cord – Connects Biodecontamination Unit to Facility power. 2. Desiccant Cartridge – Converts Sterilant into water vapor and oxygen.
6-1010087252 Operator ManualSupplemental InformationFigure 6-8. Component Identification3. Cup Draw Tube – Draws Sterilant from Sterilant Cup.4. Cup – Disposable Cup supplies Vaprox 59 Hydrogen Peroxide Sterilant. 5. USB Port – Biodecontamination Unit outputs cycle data in encrypted format for data storage through this port.6. ON/OFF Switch – Enables power to controller.7. Start Touch Pad – When pressed, starts cycle.8. Abort Touch Pad - When pressed, aborts cycle.9. Operation Screen – Can contain up to four lines of Operational text to enable operator to communicate with controller.6.10 Operation The following information is intended to enable a Trained and Certified Applicator to properly use the Biodecontamination Unit to Biodecontaminate an Enclosure (refer to SECTION 2.1, TERMS AND DEFINITIONS):The STERIS X10 Biodecontamination Unit is to be used by Trained and Certified Applicators who have successfully completed both the STERIS Training and Certification Course for applicators of Vaprox 59 Hydrogen Peroxide Sterilant and the STERIS X10 Biodecontamination Unit Operator Course. Certification must be active and in force for all Applicators of Vaprox 59 Hydrogen Peroxide Sterilant.1. Ensure Biodecontamination Unit is properly attached to Enclosure (refer to SECTION 3.2.1, ATTACH TO ENCLOSURE).To Sash PlateAssemblyTo Exhaust Plenum Adapter Supply Door Fastening Screws DesiccantCartridgeCup Draw Tube and Lid,and Sterilant CupON/OFF SwitchStart Touch PadAbort Touch PadOperation ScreenPower CordRS-232 PortUSB Port
6-11Supplemental Information Operator Manual100872522. Per FMP*, make all necessary preparations to Enclosure. Verify CIs and BIs are placed inside Enclosure as required.*Guidance for developing a suitable FumigationManagement Plan can be found in STERISpublication (P129383-938) or searching EPAwebsite (epa.gov) for the key words ’VaproxPackage Insert.’ 3. Plug Biodecontamination Unit power cord into proper facility outlet(120 Vac, 20A or 230 Vac, 10A; single source circuit).4. Turn Biodecontamination Unit power ON using ON/OFF switch.5. Control tells operator to install Cup as follows:a. Open supply door by turning fastening screws (quarter turn). When door is opened, control panel reads:b. Wearing proper PPE, unpack desiccant cartridge and Vaprox 59 Sterilant Cup from packaging. c. Ensure Sterilant Cup is not expiredd. Place Sterilant Cup and desiccant cartridge into unit. NOTE: See SECTION 6.6, STERILANT CUP INSTALLATION ANDREMOVAL, and Section 6.7, Desiccant Installation and Removal,for more information of desiccant cartridge and Sterilant Cupinsertion.e. Carefully insert draw tube into Cup.f. Close supply door and lock using fastening screws.6. Once door is closed and locked, control displays:7. After pressing START, control displays:OPEN DOOR INSERT VAPROX CUP INSERT VAPROX CUP AND DESICCANT THEN CLOSE DOOR PRESS <START> TO CONTINUE INSERT USB LOGGING FLASH MEMORY DRIVE OR PRESS <START>TO CONTINUE
6-1210087252 Operator ManualSupplemental Information8. Biodecontamination Unit drum assembly rotates and heating ofEnclosure starts. Display shows:9. When setpoint is reached, Dehumidify phase starts and displayshows:10. When setpoint is reached, Warm-Up phase starts and display shows:11. When setpoint is reached, heater cap is heated and display shows:12. When setpoint is reached, Condition phase starts and display shows:3-4 FT CABINET CYCLE PREHEATING CABINET RH = XX.X% CT = XX.X °C REM TIME xx:xx 3-4 FT CABINET CYCLE DEHUMIDIFYINGRH = XX.X% CT = XX.X°C REM TIME = XX:XX3-4 FT CABINET CYCLE WARMING UP CABINET RH = XX.X% CT = XX.X°C REM TIME = XX:XX3-4 FT CABINET CYCLE HEATING HEATER CAP RH = XX.X% CT = XX.X°C REM TIME = XX:XX3-4 FT CABINET CYCLE CONDITIONRH = XX.X% CT = XX.X°C REM TIME = XX:XX
6-13Supplemental Information Operator Manual1008725213. When setpoint is reached, Decontamination phase starts and display shows:14. When setpoint is reached, Biodecontamination Unit enters a Hold phase and display shows:15. At completion of Hold phase, drum rotates, Aeration phase starts and display shows:16. If optional aeration is desired, proceed as follows:a. Verify Biodecontamination Unit has reached Aeration phase of Cycle. Press Cancel button.b. Display asks, USE EXTERNAL AERATOR? Press Check button.c. Turn Biodecontamination Unit OFF. d. Turn Enclosure fan OFF.e. Position VHP AR60™ Aerator near Enclosure. f. Disconnect Outlet and Inlet Hose Assemblies from Biodecontamination Unit and connect to AR60 Aerator (refer to FIGURE 3-6).g. Plug AR60 Aerator into applicable wall outlet (120 or 230 Vac).h. Turn AR60 Aerator ON by pressing power switch.i. Turn Enclosure fan ON.j. Allow AR60 Aerator to operate until H2O2 is reduced to a safe level of less than or equal to 1 PPM.3-4 FT CABINET CYCLE DECONTAMINATIONRH = XX.X% CT = XX.X°C REM TIME = XX:XX3-4 FT CABINET CYCLE HOLDINGRH = XX.X% CT = XX.X°C REM TIME = XX:XX3-4 FT CABINET CYCLE MANDATORY AERATION RH = XX.X% CT = XX.X°C REM TIME = XX:XX
6-1410087252 Operator ManualSupplemental Information17. At completion of Aeration phase, drum rotates, door unlocks and display shows:18. Alarm sounds, press Check pushbutton to silence. Screen returns to Home Screen and is ready for next cycle.3-4 FT CABINET CYCLE DECON. AND AERATION COMPLETE-PRESS KEY

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