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10087252

Operator Manual

Introduction

The base lan

e of this document is

ENGLISH. Any translations must be

made from the base lan

e document.

EC Authorized Representative

STERIS Ltd

Chancery

House

190 Waterside Road
Hamilton Industrial Park
Leicester LE5 1QZ UK

STERIS Corporation

5960 Heisley Road

Mentor, OH 44060-1834 USA

440-354-2600 • 800-444-9009

www.steris.com

STERIS CORPORATION

6515 Hopkins Road

Mentor, OH 44060 • USA

Summary of Contents for VHP X10

Page 1: ...OPERATOR MANUAL X10 Biodecontamination Unit TEAM 10087252 ...

Page 2: ......

Page 3: ...vice the equipment or handle the Sterilant until you have become familiar with this information Any alteration of the unit not authorized or performed by STERIS Life Sciences voids the warranty could adversely affect Biodecontamination efficacy and could violate national state and local regulations Vaprox 59 Hydrogen Peroxide Sterilant have been EPA registered by STERIS in accordance with Federal ...

Page 4: ...s process utilizes hydrogen peroxide vapor as a broad spectrum anti microbial without condensation of the active ingredient onto surfaces with good material compatibility The Biodecontamination Unit comes with two programmed cycles designed to achieve a minimum of a 6 log bioburden reduction in a Class 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...

Page 5: ...formance invalidation of the warranty or other costly damage Customers are encouraged to contact STERIS Life Sciences concerning our annual maintenance program Under the terms of the program preventive maintenance adjustments and replacement of worn parts are provided on a scheduled basis to help ensure optimal equipment performance and to help minimize untimely or costly schedule interruptions ST...

Page 6: ...made from the base language document ECAuthorizedRepresentative STERIS Ltd Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ UK STERIS Corporation 5960 Heisley Road Mentor OH 44060 1834 USA 440 354 2600 800 444 9009 www steris com STERIS CORPORATION 6515 Hopkins Road Mentor OH 44060 USA ...

Page 7: ...orming Routine Maintenance 5 1 5 2 Clean Biodecontamination Unit 5 2 5 3 Clean Hoses 5 3 5 4 Cleaning Touch Screen 5 4 5 5 Replacement Parts and Supplies 5 4 5 5 1 Ordering Information 5 4 5 5 2 Supply Products 5 5 5 5 3 Recommended Spare Parts 5 5 5 6 Associated Publications 5 6 6 Supplemental Information 6 1 6 1 Installation Verification 6 1 6 1 1 Installation Checklist 6 1 6 1 2 Pre Operation C...

Page 8: ...NTENTS CONT D 6 6 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 6 7 Desiccant Installation and Removal 6 8 6 8 Sterilant Container Storage 6 9 6 9 General Component Identification 6 9 6 10 Operation 6 10 ...

Page 9: ...Open Supply Door 3 5 Figure 3 6 Connecting X10 Biodecontamination Unit and AR60 Aerator to Enclosure 3 6 Figure 6 1 X10 Biodecontamination Unit 6 3 Figure 6 2 Typical Biodecontamination Cycle 6 4 Figure 6 3 Typical Sterilant Cup 6 6 Figure 6 4 Sterilant Cup in Biodecontamination Unit Typical 6 7 Figure 6 5 Carefully Insert Draw Tube Typical 6 7 Figure 6 6 Desiccant Cartridge Typical 6 8 Figure 6 7...

Page 10: ...viii 129396 083 Operator Manual Table of Contents Life Sciences ...

Page 11: ... 2 1 Definition of Symbols 2 3 Table 4 1 Alarm Abort Actions 4 1 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 ...

Page 12: ...xii 10087252 Operator Manual Table of Contents Life Sciences ...

Page 13: ...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 o...

Page 14: ...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 ...

Page 15: ...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 ...

Page 16: ...t 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 powe...

Page 17: ... for the Biodecontamination phase Cup Vaprox 59 Hydrogen Peroxide Sterilant container 70 mL Dehumidify First phase of the Biodecontamination Cycle Achieves temperature and humidity conditions necessary for subsequent Biodecontamination phases Enclosure Contained area to be Biodecontaminated e g Class II Type A2 Biosafety Cabinet FMP Fumigation Management Plan 2 HMI Human Machine Interface such as ...

Page 18: ...stroys 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 Sterilization Complete killing of all microbial life including spores Unit Biodecontamination Uni...

Page 19: ... Has Been Tested To The Requirements Of CAN CSA C22 2 No 61010 1 Second Edition Including Amendment 1 Or A Later Version Of The Same Standard Incorporating The Same Level Of Testing Requirements Inlet Sterilant Hose Connection From Enclosure Exhaust Into Biodecontamination Unit Outlet Sterilant Hose Connection From Biodecontamination Unit Into Enclosure Work Area SN Serial Number of Unit V Voltage...

Page 20: ...2 4 10087252 Operator Manual Terms Definitions and Symbols Life Sciences ...

Page 21: ...nd Aeration for an All In One unit design while VaproxLink software technology automatically identifies Vaprox 59 Hydrogen Peroxide Sterilant Cup and verifies expiration date Other X10 Biodecontamination Unit features With 0 5 2 5 g min of Sterilant injection the Biodecontamination Unit is capable of Biodecontaminating a single Class II Type A2 cabinet from 3 6 0 9 1 8 m with an internal cabinet v...

Page 22: ... intended to enable a Trained and Certified Applicator to properly attach the Biodecontamination Unit to 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 requirement...

Page 23: ...gure 3 2 Figure 3 2 Open Biodecontamination Unit Case 5 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 Components M Power Cord Sash Support Plate Assembly Exhaust Plenum Adapter Inlet Hose Assembly Outlet Hose Assembly ...

Page 24: ...te epa gov for the key words Vaprox Package Insert 2 Wearing proper PPE unpack desiccant cartridge and Vaprox 59 Sterilant Cup from packaging see Figure 3 5 3 Ensure Sterilant Cup is not expired 4 Plug Biodecontamination Unit power cord into proper facility outlet 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 ...

Page 25: ...M 16 At completion of MANDATORY AERATION if optional aeration is not desired control continues with AERATION phase 17 Cycle completes alarm sounds and control displays COMPLETE PRESS KEY Press Check button 18 Proceed to next section Sterilant Cup For Desiccant Cartridge For Sterilant Cup Desiccant Cartridge DANGER CHEMICAL INJURY HAZARD When handling the BiodecontaminationSystem hoses wear appropr...

Page 26: ...ntamination Unit Connected to Enclosure Inlet KEY Outlet Aerator Connected to Enclosure DANGER 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 hydr...

Page 27: ...nformation as well as the information on the Vaprox 59 Hydrogen Peroxide Sterilant 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 t...

Page 28: ... 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 ...

Page 29: ...the control board Repair as needed or replace RH probe or board Control Board failure Replace control board 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 See Alarm Message 14 RH Sensor Control Board Wiring failure Verify proper operation of RH contro...

Page 30: ...heck the sterilant cup s printed SKU code 20 Sterilant Cup Bad Wrt Occurs 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 RFID Reader Writer 21 RH Sensor Not Calib Appears at any time the RH Sensor s Relative Humid...

Page 31: ...rmance and help avoid unscheduled downtime Contact STERIS Life Sciences for details Maintain a record of all maintenance procedures performed on the VHP X10 Biodecontamination Unit If a problem occurs refer to SECTION 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 a...

Page 32: ...lean lint free cloth NOTE Should it become necessary to sterilize or disinfect the outside plastic VHP X10 Biodecontamination Unit surfaces before entering an Enclosure STERIS Life Sciences recommends Spor Klenz Ready To Use Cold Sterilant This sterilant is a liquid sporicide specifically formulated for sterilization and disinfection of hard surfaces CAUTION POSSIBLE EQUIPMENT DAMAGE Use nonabrasi...

Page 33: ...ter 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 w...

Page 34: ...creen 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 Parts and Supplies Use only STERIS authorized parts on this equipment Use of unauthorized parts will void the warranty 5 5 1 Ordering Information To order replacement parts and or supply products proceed as follows 1 Include the pa...

Page 35: ...ination 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 warrant...

Page 36: ... Order directly from STERIS Life Sciences Representative FUSE Heater 5 A For 230 Vac Unit 10017003 2 HARNESS Amber Light 10020036 1 HOSE ASSEMBLY 2 Cam Lever 10038131 5 ft HOSE ASSEMBLY 2 Cam Lever 10038130 10 ft NUT Tubing P387349 030 10 TUBE Draw 10014998 1 Table 5 2 Recommended Spare Parts Cont d Description Part Number Quantity Table 5 3 Associated Publications Description Part Number Tech Dat...

Page 37: ...ration Checklist Read 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 the Biodecontamination Unit to the Enclosure refer to SECTION 2 1 TERMS AND DEFINITIONS or other system components as described in SECTION ...

Page 38: ...11700A VHPX10 IC 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 Opera...

Page 39: ...erly installed X10 Biodecontamination Unit outside the Enclosure refer to SECTION 2 1 TERMS AND DEFINITIONS uses STERIS s VHP process technology This process uses hydrogen peroxide vapor as a broad spectrum antimicrobial without condensation of active ingredient onto surfaces This non condensation feature provides additional benefit of a wide range of material compatibility In practice an aqueous ...

Page 40: ...umidification phase starts and air circulates through desiccant to dehumidify Enclosure to 15 RH NOTE During this time the liquid Sterilant is primed into the injection 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 Biodecontamina...

Page 41: ...se 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 b...

Page 42: ...isulfide 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 comp...

Page 43: ...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 Removal When the Cycle is complete or if the X10 Biodeconta...

Page 44: ...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...

Page 45: ...ed 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 and Certified Applicators who have successfully completed both the STERIS Training ...

Page 46: ...icator 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 O...

Page 47: ...oor 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 expired d Place Sterilant Cup and desiccant cartridge into unit NOTE See SECTION 6 6 STERILANT CUP INSTALLATION AND REMOVAL and Section 6 7 Desiccant Installation and Removal for more informatio...

Page 48: ...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 DEHUMIDIFYING RH XX X CT XX X C REM TIME XX XX 3 4 FT CABINET CYCLE WARMING UP CABINET RH XX X CT XX X C REM TIME XX XX 3 4 FT CABINET CYCLE HEATING HEATER CAP RH XX X CT...

Page 49: ...ress 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 ...

Page 50: ...tion 17 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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