Steris VHP X10 Operator's Manual
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Steris VHP X10 Operator's Manual

Steris VHP X10 Operator's Manual

Biodecontamination unit
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OPERATOR MANUAL
™
X10
Biodecontamination Unit
(TEAM)
10087252

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  • Page 1 OPERATOR MANUAL ™ Biodecontamination Unit (TEAM) 10087252...
  • Page 3 ERMS AND EFINITIONS this document. This manual describes the STERIS Biodecontamination Process using Vaprox 59 Hydrogen 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 Sterilant label and package insert for detailed Safety Precautions and application instructions.
  • Page 4 Intended Use NOTE: The 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 DANGER – FIRE AND EXPLOSION HAZARD: Hydrogen Peroxide Sterilant and the X10 Biodecontamination Unit Operator Course.
  • Page 5 STERIS Life Sciences maintains a worldwide staff of well- equipped, factory-trained technicians to provide these services, as well as on-site installation, training and expert repair services. Contact STERIS Life Sciences** for details.
  • Page 6 STERIS CORPORATION 6515 Hopkins Road Mentor, OH 44060 • USA The base language of this document is ENGLISH. Any translations must be made from the base language document. EC Authorized Representative STERIS Ltd. Chancery House 190 Waterside Road Hamilton Industrial Park...

  • Page 7: Table Of Contents

    TABLE OF CONTENTS Section Number Description Page Safety Precautions ........................1-1 Terms, Definitions and Symbols ....................2-1 Terms and Definitions ..........................2-1 Symbols ..............................2-3 Operating Instructions ........................3-1 Introduction ............................3-1 Operation ............................... 3-2 3.2.1 Attach to Enclosure ........................3-2 3.2.2 Prepare Enclosure and Biodecontamination Unit..............
  • Page 8 TABLE OF CONTENTS (CONT’D) Section Number Description Page Sterilant Cup Installation and Removal....................6-6 6.6.1 Cup Installation......................... 6-7 6.6.2 Cup Removal..........................6-7 6.6.3 Disposal of Sterilant From Cup ....................6-8 Desiccant Installation and Removal....................... 6-8 Sterilant Container Storage ........................6-9 General Component Identification ......................
  • Page 9 LIST OF FIGURES Description Page Figure 3-1. VHP X10 Biodecontamination Unit in Cases ................3-3 Figure 3-2. Open Biodecontamination Unit Case..................3-3 Figure 3-3. Accessory Case Components ....................3-3 Figure 3-4. Connect Biodecontamination Unit to Enclosure .................3-4 Figure 3-5. Open Supply Door ........................3-5 Figure 3-6.
  • Page 10 viii 129396-083 Operator Manual Table of Contents...
  • Page 11 Table 4-2 Power Interruption/Power-Up Actions ..................... 4-1 Table 4-3 Troubleshooting Guide ........................4-2 Table 5-1 VHP X10 Biodecontamination Unit Selected Supply Products ............5-5 Table 5-2 Recommended Spare Parts ......................5-5 Table 5-3 Associated Publications ........................5-6 Table of Contents...
  • Page 12 10087252 Operator Manual Table of Contents...

  • Page 13: Safety Precautions

    NOTE: Disregarding the presented safety information is considered ABNORMAL USE of this product. If the equipment is used in a manner not specified by STERIS, the protection provided by the equipment may be impaired. DANGER – SLIPPING HAZARD: Water or hydrogen peroxide spilled on the floor presents a slipping hazard –...
  • Page 14 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...
  • Page 15 DANGER – 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.
  • Page 16 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, impair equipment protection design, result in improper equipment performance, invalidate the warranty or result in costly damage.

  • Page 17: Terms, Definitions And Symbols

    PLC – Programmable Logic Controller. When using STERIS X10 Biodecontamination Units with Vaprox 59 Hydrogen Peroxide Sterilant in the United States, the term Biodecontamination referred to in this Operator Manual is defined as Sterilization of exposed porous and non-porous surfaces in a precleaned, dry, sealed Enclosure.

  • Page 18: Terms And Definitions

    Sporicidal – Antimicrobial activity which destroys or eliminates all forms 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 other additives making it suitable for STERIS VHP Biodecontamination Units.

  • Page 19: Symbols

    2.2 Symbols Table 2-1 contains symbols which may appear on your STERIS X10 Biodecontamination Unit components. Table 2-1. Definition of Symbols Symbol Definition Protective Earth (Ground) Electrostatic Sensitive Device Electric Shock Hazard Attention, Consult Manual for Further Instructions This Product Has Been Tested To The Requirements Of CAN/CSA-C22.2 No.
  • Page 20 10087252 Operator Manual Terms, Definitions and Symbols...

  • Page 21: Operating Instructions

    ERMS AND EFINITIONS this document. This manual describes the STERIS Biodecontamination Process using Vaprox 59 Hydrogen 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 Sterilant label and package insert for detailed Safety Precautions and application instructions.

  • Page 22: Operation

    70 mL of Vaprox 59 Hydrogen Peroxide Sterilant. 3.2 Operation NOTE: 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.

  • Page 23: Figure 3-1. Vhp X10 Biodecontamination Unit In Cases

    Figure 3-1. VHP X10 Biodecontamination Unit in Cases 4. Unlatch (all six) Biodecontamination Unit case cover and lift cover (see Figure 3-2). Figure 3-2. Open Biodecontamination Unit Case 5. Open Accessories Case (see Figure 3-3) and unpack accessories: • Inlet Hose Assembly •...

  • Page 24: Prepare Enclosure And Biodecontamination Unit

    6. Attach Sash Plate Assembly to Enclosure. 7. Attach Exhaust Plenum Adapter to Enclosure. 8. Connect hoses from VHP X10 Biodecontamination Unit to Enclosure (see Figure 3-4). Follow labels on Biodecontamination Unit. To Exhaust Plenum Adapter To Sash Plate Assembly...

  • Page 25: Figure 3-5. Open Supply Door

    Sterilant Cup For Desiccant Cartridge For Sterilant Desiccant Cartridge Figure 3-5. Open Supply Door 12. Follow screen prompt, insert USB device or press Start. DANGER – CHEMICAL 13. Follow display commands as cycle proceeds (refer to INJURY HAZARD: 6.4, B ECTION IODECONTAMINATION YCLE...

  • Page 26: Cycle Completion

    VHP X10 VHP X10 Enclosure Enclosure VHP AR60 VHP AR60 Biodecontamination Unit Connected to Enclosure Aerator Connected to Enclosure KEY: Inlet Outlet Figure 3-6. Connecting Biodecontamination Unit and AR60 Aerator to Enclosure 3.2.3 Cycle Completion DANGER – CHEMICAL INJURY HAZARD: •...

  • Page 27: Troubleshooting

    Enclosure during or If a situation occurs that is not described in this manual, please call after an aborted cycle without STERIS Life Sciences. Trained service personnel can promptly SCBA and appropriate PPE restore this X10 Biodecontamination Unit to proper working order.

  • Page 28: Table 4-3 Troubleshooting Guide

    – Close Door interlock switch • Safety interlock switch failure or wiring disconnected/shorted. • Contact STERIS. 3. Door Interlock Fail Occurs at any time during a cycle • Safety interlock switch failure or wiring and after the dehumidify phase, disconnected/shorted.
  • Page 29 Table 4-3. Troubleshooting Guide (Cont’d) Alarm Message Possible Causes and / or Description Display Corrections 9. Cabinet Temp RTD Occurs at any time, the Airflow • Sensor failure or wiring disconnected/ Fail RTD (RTD2) temperature reading shorted: Check RTD2 connector indicates a break or short in the connector on control board.
  • Page 30 • Verify proper torque on rear drum assembly retaining bolt. 25. Control Board Fail Occurs at any time a Control • TBD. Board fault is issued by the Control Board * STERIS Life Sciences 10087252 Operator Manual Troubleshooting...

  • Page 31: Routine Maintenance

    Performing Routine procedures not included in this section should be performed only by Maintenance STERIS Life Sciences Service or STERIS-trained service personnel fully acquainted with the equipment. WARNING – PERSONAL In addition to the routine maintenance described in this section,...

  • Page 32: Clean Biodecontamination Unit

    5.2 Clean STERIS Life Sciences recommends cleaning the outside surfaces of the VHP X10 Biodecontamination Unit with a mild detergent solution Biodecontamination (such as Liqui-Jet ™ 2 Instrument Detergent). Unit Clean the Biodecontamination Unit as follows: CAUTION – POSSIBLE 1. Unplug unit.

  • Page 33: Clean Hoses

    5.3 Clean Hoses NOTE: Condensation inside the hoses must be assumed to be concentrated hydrogen peroxide (H ). Review the DANGERS, WARNINGS and CAUTIONS located below and in ECTION , of this manual before handling the hoses. AFETY RECAUTIONS Also, read and comply with the Safety Precautions outlined on the Vaprox 59 Hydrogen Peroxide Sterilant MSDS and the Vaprox 59 ®...

  • Page 34: Cleaning Touch Screen

    3. Send your order directly to the STERIS Life Sciences personnel. Maintenance Representative serving your area. performed by unqualified personnel or installation of Contact STERIS Life Sciences* if you need parts that are not listed in unauthorized parts could this manual. cause personal injury, result in improper equipment...

  • Page 35: Supply Products

    5.5.2 Supply Products NOTE: Use only STERIS U.S. EPA-registered Vaprox 59 Hydrogen Peroxide Sterilant in STERIS Containers. Vaprox Containers contain DANGER – PERSONAL high purity 59% hydrogen peroxide and are filled under controlled INJURY, CONTAMINATED conditions to ensure effectiveness through the expiration date stamped ENCLOSURE AND/OR on the label.

  • Page 36: Associated Publications

    10014998 5.6 Associated Publications listed in this section are those associated with the use and maintenance of this VHP X10 Biodecontamination Unit. Publications When ordering, please include the part number (if applicable), description and quantity of each publication requested. Order directly from STERIS Life Sciences Representative.

  • Page 37: Supplemental Information

    Uncrating/Installation Instructions were furnished with the X10 Biodecontamination Unit. If these documents are missing or misplaced, contact STERIS Life Sciences, giving the serial, equipment and model numbers of the unit. Replacement copies will be sent to you promptly. NOTE: Do not use Unit in an area not compatible with oxidizers.

  • Page 38: Technical Data

    ❑ Biodecontamination Unit components are properly positioned in relation to Enclosure (refer to 2.1, T ECTION ERMS AND EFINITIONS being processed, as described in 3.2, O ECTION PERATION ❑ The X10 Biodecontamination Unit components are properly connected (refer to Figure 3-4 Figure 3-6).

  • Page 39: Hydrogen Peroxide Biodecontamination

    X10 Biodecontamination Unit. Vaprox 59 Hydrogen Peroxide Sterilant has been registered by STERIS in Figure 6-1. Biodecontamination Unit accordance with U.S. Federal Regulations for the specific uses...

  • Page 40: Figure 6-2. Typical Biodecontamination Cycle

    The Biodecontamination Cycle (see Figure 6-2) proceeds as follows: 1. Biodecontamination Unit display prompts Trained and Certified Applicator to insert Vaprox 59 Hydrogen Peroxide Sterilant Cup and desiccant cartridge (see 6.6, S ECTION TERILANT NSTALLATION 6.7, D EMOVAL ECTION ESICCANT NSTALLATION AND EMOVAL 2.

  • Page 41: Hydrogen Peroxide Handling Precautions

    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...

  • Page 42: Sterilant Cup Installation And Removal

    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 –...

  • Page 43: Cup Installation

    6.6.1 Cup Installation Install Vaprox 59 Hydrogen Peroxide Sterilant Cup (see 6-3) as IGURE follows: 1. Wearing proper PPE, unpack desiccant cartridge and Vaprox 59 Sterilant Cup from packaging (refer to 3-5). IGURE 2. Check Cup expiration date. Do not use Cup if beyond expiration date listed on label (Figure 6-3).

  • Page 44: Disposal Of Sterilant From Cup

    2. 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 next Section 6.6.3, D...

  • Page 45: Sterilant Container Storage

    NOTE: The 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 Hydrogen Peroxide Sterilant and the X10 Biodecontamination Unit Operator Course. Certification must be active and in force for all Applicators of Vaprox 59 Hydrogen Peroxide Sterilant.

  • Page 46: Operation

    ECTION ERMS AND EFINITIONS 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.
  • Page 47 CIs and BIs are placed inside Enclosure as required. 3. Plug Biodecontamination Unit power cord into proper facility outlet *Guidance for developing a suitable Fumigation Management Plan can be found in STERIS (120 Vac, 20A or 230 Vac, 10A; single source circuit). publication (P129383-938) or searching EPA 4.
  • Page 48 8. Biodecontamination Unit drum assembly rotates and heating of Enclosure starts. Display shows: 3-4 FT CABINET CYCLE PREHEATING CABINET = XX.X% CT = XX.X °C REM TIME xx:xx 9. When setpoint is reached, Dehumidify phase starts and display shows: 3-4 FT CABINET CYCLE DEHUMIDIFYING = XX.X% CT = XX.X°C REM TIME = XX:XX...
  • Page 49 13. When setpoint is reached, Decontamination phase starts and display shows: 3-4 FT CABINET CYCLE DECONTAMINATION = XX.X% CT = XX.X°C REM TIME = XX:XX 14. When setpoint is reached, Biodecontamination Unit enters a Hold phase and display shows: 3-4 FT CABINET CYCLE HOLDING = XX.X% CT = XX.X°C REM TIME = XX:XX...
  • Page 50 17. At completion of Aeration phase, drum rotates, door unlocks and display shows: 3-4 FT CABINET CYCLE DECON. AND AERATION COMPLETE-PRESS KEY 18. Alarm sounds, press Check pushbutton to silence. Screen returns to Home Screen and is ready for next cycle. 6-14 10087252 Operator ManualSupplemental Information...

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