VHP ARD BIODECONTAMINATION SYSTEM

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VHP ARD BIODECONTAMINATION SYSTEM APPLICATION The VHP ARD Biodecontamination System is designed for portable biodecontamination* of clean, dry, sealed Enclosures.** The VHP 1000-ARD Biodecontamination Unit is portable and can be brought to (or placed inside) the Enclosure to be biodecontaminated. The VHP ARD Biodecontamination System consists of the following devices: VHP 1000-ARD Biodecontamination Unit; Dryer Regenerator; High Capacity Dryer Tank or Dryer Cartridge; Sensing Unit; Auxiliary Aeration Unit (High Capacity Catalytic Converter); Room Circulation Unit; and Contactor Unit. * When using VHP equipment with Vaprox Hydrogen Peroxide Sterilant in the United States, the term biodecontamination referred to in this Tech Data 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 impart additional claims of effectiveness beyond that approved in the EPA registered labeling of Vaprox Hydrogen Peroxide Sterilant for use on precleaned, dry, exposed porous and non-porous surfaces in a sealed Enclosure. * * Contained area to be biodecontaminated (e,g,, hotel rooms, hospital rooms, emergency vehicles and laboratories). DESCRIPTION The VHP 1000-ARD Biodecontamination Unit is a hydrogen peroxide (H 2 O 2 ) vapor generator that operates at ambient temperature and atmospheric pressure to offer operating flexibility. The biodecontamination unit can be easily transported between multiple Enclosures for biodecontamination. To minimize exposure to the liquid hydrogen peroxide during handling, the system uses Vaprox Hydrogen Peroxide Sterilant cartridges containing 950 ml of sterilant. The Vaprox Hydrogen Peroxide Sterilant is specially formulated for maximum efficacy and for component compatibility. Use only Vaprox Hydrogen Peroxide Sterilant cartridges, containing STERIS-registered hydrogen peroxide which has been specially formulated, tested and approved for use in the VHP 1000-ARD Biodecontamination Unit. Vaprox Hydrogen Peroxide Sterilant has been registered by STERIS in accordance with U.S. Federal Regulations for specific usage with the VHP ARD Biodecontamination System. STANDARDS (Typical only - some details may vary.) The biodecontamination system components (including biodecontamination unit control system) meets the applicable requirements of the following standards: CE Mark per:» EMC Directive 89/336/EEC, 92/31/EEC, 93/68/EEC.» Low Voltage Directive 73/23/ EEC, 93/68/EEC. ETL (UL) per EN/UL61010-1. CSA per CSA 22.2 61010-1. The Selections Checked Below Apply To This Equipment VOLTAGES 120 Vac, 60 Hz 230 Vac, 50/60 Hz ACCESSORIES Contactor Unit Dryer Cartridge High Capacity Dryer Tank Dryer Regenerator Sensing Unit (H 2 O 2 and H 2 O) Auxiliary Aeration Unit Room Circulation Unit OPTIONS Language English French German Italian Spanish Printer Item Location(s) SD840 (11/01/07)

CYCLE DESCRIPTION The VHP 1000-ARD Biodecontamination Unit uses a closedloop process or configuration utilizing conditioned air as a carrier to deliver Vaprox Hydrogen Peroxide Sterilant vapor to exposed surfaces inside a pre-cleaned, dry, sealed Enclosure. This closed-loop configuration allows the biodecontamination process to take place at, or near, atmospheric pressure. The maximum Vaprox Hydrogen Peroxide Sterilant vapor concentration achievable depends on the temperature, volume and humidity of the sealed Enclosure. Vaprox Hydrogen Peroxide Sterilant vapor is maintained at the target concentration for the required exposure time to achieve biodecontamination. The Vaprox Hydrogen Peroxide Sterilant vapor evacuated from the Enclosure in a closed-loop operation is catalytically converted by the VHP ARD Biodecontamination Unit (and/or auxiliary aeration unit) into water vapor and oxygen. The Biodecontamination Cycle consists of four phases: DEHU- MIDIFY, CONDITION, BIODECONTAMINATION and AERATION. NOTE: Pressure control is not available. Dehumidify Dry, HEPA-filtered (High Efficiency Particulate Air) air is circulated to reduce humidity to a predetermined level in the 10-70% relative humidity range. This permits the necessary Vaprox Hydrogen Peroxide Sterilant vapor concentration to be maintained below saturation (dew point) levels during the Condition and Biodecontamination phases. The return air is dried as it passes through the dryer and then heated to serve as the carrier for the Vaprox Hydrogen Peroxide Sterilant. The internal HEPA filter prevents contamination of internal machine components and prevents recontamination of the Enclosure. A particle filter is also supplied to protect the 1000-ARD vaporizer. NOTE: Time to reach the targeted humidity corresponds with the initial humidity, temperature and the volume of the Enclosure. Condition The flow of dry, HEPA-filtered air continues while Vaprox Hydrogen Peroxide Sterilant vapor is injected into the air stream just before it leaves the Biodecontamination Unit. Vaprox Hydrogen Peroxide Sterilant vapor is injected into the Enclosure to reach the target biodecontamination VHP Sterilant concentration. The Condition phase facilitates reaching this target biodecontamination concentration faster in larger volume sealed Enclosure applications. Condition time is affected by Vaprox Hydrogen Peroxide Sterilant injection rate, Enclosure volume, Enclosure contents and temperature. The VHP ARD Biodecontamination System, through use of optional sensing unit, is capable of automatically developing the needed condition time and injection rate. Biodecontamination The target Vaprox Hydrogen Peroxide Sterilant concentration is maintained for a specific period of time throughout the Enclosure. The VHP ARD Biodecontamination System, through use of optional sensing unit, is capable of automatically controlling the sterilant concentration. Aeration The Vaprox vapor injection is stopped and the recirculating flow of dry, HEPA-filtered air continues through the catalytic converter (and/or auxiliary aeration unit) to reduce the Vaprox Hydrogen Peroxide Sterilant vapor concentration within the Enclosure. CYCLE DEVELOPMENT SUPPORT STERIS can provide on-site support to properly develop the Biodecontamination Cycle for your specific application. ACCESSORIES The completely portable VHP ARD Biodecontamination System is flexible enough to biodecontaminate a variety of Enclosures. Some of the accessories available to enable this flexibility are as follows (see Pages 5 and 6): Contactor Unit This optional device is used to activate an optional larger dehumidifier and/or High Capacity Catalytic Converter for use in larger Enclosures. Dryer Cartridge The VHP 1000-ARD Biodecontamination Unit uses a reusable desiccant cartridge to dry the air stream in the VHP process. The cartridge is capable of containing the water vapor produced by the vaporization of 600 grams of Vaprox Hydrogen Peroxide Sterilant as well as the water vapor initially existing inside the Enclosure. Once the reusable dryer cartridge reaches its capacity (cannot contain the water vapor generated in the next cycle), it must be regenerated. High Capacity Dryer Tank For larger Enclosures or more cycle capability, the VHP 1000- ARD Biodecontamination Unit may use this desiccant high capacity dryer tank to dry the air stream in the VHP process. The tank is capable of containing the water vapor produced by the vaporization of two liters of Vaprox Hydrogen Peroxide Sterilant as well as the water vapor initially existing inside the Enclosure. Once the dryer tank reaches its capacity (cannot contain the water vapor generated in the next cycle), it must be regenerated. Mounted on wheels for easy portability. Dryer Regenerator The Dryer Regenerator is used to remove the water from the desiccant within either the reusable dryer cartridge or the High Capacity Dryer Tank. Mounted on wheels for easy portability and supplied with insulation blankets to protect hot surfaces on High Capacity Dryer Tank and connecting hoses or dryer cartridge. Sensing Unit (H 2 O 2 and H 2 O) This optional sensor measures the hydrogen peroxide and water concentrations in the Enclosure. The sensor supplies this concentration data to the VHP 1000-ARD Biodecontamination 2

Unit for cycle operation. Up to three sensors can be operated simultaneously for additional feedback control of the hydrogen peroxide concentration and condensation prevention. Auxiliary Aeration Unit This optional, external to the VHP 1000- ARD Biodecontamination Unit, high capacity catalytic converter enables aeration of Enclosures at a higher rate and reduces the aeration time. Room Circulation Unit This optional blower unit circulates the Vaprox Hydrogen Peroxide Sterilant throughout the Enclosure for optimal sterilant distribution. FEATURES The VHP 1000-ARD Biodecontamination Unit is supplied with a control touch panel that includes a 1/4 VGA monochrome display window, touch-sensitive keypads, and an impact printer (optional) to allow easy initiation, option setting and monitoring of cycles. These features are as follows: Touch panel the B&R Power Panel 220 directs all Biodecontamination Unit functions. From this control touch panel, the operator may control cycle operation, program cycles, and unit operating parameters, as well as monitor cycle performance. By pressing the Power Panel 220 touch panel, a fully-trained, certified operator (see NOTE 1) can start or cancel a cycle, check the cycle phase while the unit is in-cycle, change or set option selections, and advance the printer (optional) paper. Printer (optional) 40 character, dot matrix, ink-on-paper, impact-type printer with a takeup motor records all cycle data on 57 mm (2-1/4") wide, single-ply paper. Printouts (optional) list key cycle data, including date, time the cycle was started, Biodecontamination Unit ID, and cycle count. Cycle printouts also include vaporizer/return temperature, reservoir level, and relative humidity of return air. Any cycle faults are listed and warn the operator of incomplete biodecontamination, should a fault occur. Diagnostic cycles also indicate whether the Biodecontamination Unit passed or failed (and if so, the reason for the failure). The printout will also list options that can be programmed. Control system includes preprogrammed biodecontamination cycles that can be used for typical processing requirements. Remote Operation port enables Biodecontamination Unit to be connected to a personal computer (not supplied by STERIS) for remote operations. Wireless operation is also available using wireless router. H 2 O 2 warning light warns user that Vaprox Hydrogen Peroxide Sterilant vapor may be present in the Enclosure. Data Logging is cycle data, including peroxide concentration, logged onto USB memory sticks in an encrypted format. Printout information is also stored in an encrypted file on the memory stick. This data is then available for viewing and graphing using standard PC software. CONTROL VALUE SETTINGS Cycle values (e.g., time and temperature) can be adjusted by the operator; however, certain control settings are supervisoradjustable: Time set sets current time of day for displays and printouts. Date set sets current date for displays, printouts. Access code limits access to certain options to authorized, fully-trained and certified operators. End-of-cycle tone generates an audible tone at the end of each cycle. Time format sets the sequence for time displays and printouts in AM/PM or 24-hour format. Date format sets the sequence for date displays and printouts (month/ day/year, day/month/year, year/ month/ day). CONSTRUCTION VHP 1000-ARD Biodecontamination Unit Body: Powdercoated aluminum body and side panels. The sealed enclosed bottom contains Vaprox Hydrogen Peroxide Sterilant leaks and is equipped with leak detection. VHP 1000-ARD Biodecontamination Unit Vaprox Hydrogen Peroxide Sterilant Cartridge Interface: Flame-resistant plastic. The Vaprox Sterilant is metered with a precision pump. Reusable Desiccant Cartridge: Aluminum housing with molecular sieve desiccant. Dryer Regenerator: Carbon-steel housing with aluminum frame. Mounted on wheels for easy portability. Sensing Unit: Plastic enclosure with stainless-steel support frame. High Capacity Dryer Tank: Aluminum, wheel-mounted housing with molecular sieve desiccant. Contactor Unit: Plastic box with stainless-steel frame. Auxiliary Aeration Unit: Aluminum casing. Circulation Module: Aluminum casing and mounted on wheels for easy portability. CALIBRATION STERIS recommends that all VHP 1000-ARD Biodecontamination Units be calibrated at least twice a year. Control warns user when calibration is required. STERIS can provide this calibration service. Each sensing unit (H 2 O 2 and H 2 O sensor) accessory contains a memory stick containing that particular sensor s calibration data. PREVENTIVE MAINTENANCE Customers are encouraged to contact STERIS concerning the 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 help minimize untimely or costly schedule interruptions. STERIS maintains a worldwide staff of well-equipped, factory-trained technicians to provide 3

these services, as well as on-site installation, training, and expert repair services. Contact STERIS for details. NOTES 1. Applicators must complete the "Training and Certification Course for Applicators of Vaprox 35% Hydrogen Peroxide Sterilant." Users must complete all certification criteria. 2. Enclosure (if emergency vehicle or similar) must be in an adequately ventilated area during biodecontamination. Enclosure surfaces to be treated must be clean and dry. No visible soil allowed. 3. STERIS recommends that a dedicated, grounded electrical circuit be provided for each unit. Extension cord use is not recommended. 4. Unit should be operated in an area which is compatible with oxidizers. Consult the MSDS regarding Vaprox Hydrogen Peroxide Sterilant. 5. Access must be provided to power switch and hose connectors located on the front and back of the biodecontamination unit. 6. When used, hose clearance must be adequate to prevent kinks and strains on the connectors. 7. When used, hoses must be supported to keep them from resting on the floor or other cold surfaces. 8. Access must be provided for desiccant (dryer) cartridge and/or High Capacity Dryer Tank installation and removal. 9. Dryer Regenererator must be on a hard, level surface. AIRFLOW Airflow range: 8-20 scfm (14-34 m 3 /h) ENVIRONMENTAL FACTORS Room Temperature: 60-100 F (16-38 C) Maximum Humidity: 85% non-condensing A-Weighted Sound Power Level: 73 dba (mean) - 83 dba (maximum) Refer to the VHP 1000-ARD Biodecontamination System and Dryer Regenerator equipment drawings for additional information. OPERATING WEIGHT VHP 1000-ARD Biodecontamination Unit: 150 lb (68 kg) High Capacity Dryer Tank: 60 lb (27 kg) Dryer Cartridge: 32 lb (15 kg) Dryer Regenerator: 90 lb (41 kg) Sensing Unit: 17 lb (8 kg) Room Circulation Unit: 50 lb (23 kg) Auxiliary Aeration Unit: 50 lb (23 kg) Contactor Unit: 16 lb (7 kg) ELECTRICAL REQUIREMENTS VHP 1000-ARD Biodecontamination Unit:» 120 Vac, 18 Amp, 60 Hz» 230 Vac, 9 Amp, 50/60 Hz Dryer Regenerator:» 120 Vac, 11 Amp, 60 Hz» 230 Vac, 6 Amp, 50/60 Hz Auxiliary Aeration Unit:» 120 Vac, 1 Amp, 60 Hz» 230 Vac, 1 Amp, 50/60 Hz Contactor Unit:» 120 Vac, 20 Amp, 60 Hz» 230 Vac, 20 Amp, 50/60 Hz Room Circulation Unit:» 120 Vac, 2 Amp, 60 Hz» 230 Vac, 1 Amp, 50/60 Hz CUSTOMER IS RESPONSIBLE FOR COMPLIANCE WITH APPLICABLE LOCAL AND NATIONAL CODES AND REGULATIONS. STERIS Corporation, Mentor (Hopkins) Ohio is an ISO 13485 and ISO 9001 certified facility. The base language of this document is ENGLISH. Any translations must be made from the base language document. 4

Control Touch Panel Optional Printer Main Power Switch Sterilant Outlet Return Air Input/Output Connections Dryer Connections Main Power Receptacle Front View Rear View Typical VHP 1000-ARD Biodecontamination Unit With Dryer Cartridge With High Capacity Dryer Tank Typical VHP ARD Dryer Regenerator and Dryer Cartridges 5

Dryer Cartridge High Capacity Dryer Tank Room Circulation Unit Auxiliary Aeration Unit Contactor Unit Sensing Unit Typical VHP ARD Biodecontamination System Components 6

Refer to the Following Equipment Drawing for Installation Details Equipment Drawing Part Number Equipment Drawing Title 146668-818 Equipment Drawing, ARD Assembly Dimensions are typical drawing is not to scale. Ethernet COM P6 Dimensions are inches (mm) 37-1/4 (949) USB P5 Detail A ON/OFF Top View Controller Optional Printer Vaprox Cartridge Interface Dryer Return P1 P7 Dryer Input Detail A Rear View Power Plug Biodecontaminant Out 40-1/4 (1023) Air Return Side View Iso View 7

Refer to the Following Equipment Drawing for Installation Details Equipment Drawing Part Number Equipment Drawing Title 146668-791 Equipment Drawing, Dryer/Regenerator 146668-821 Equipment Drawing, Assembly, Dryer/Module Dimensions are typical drawing Dimensions is not to Are scale. inches (mm) 17-7/8 (454) Door Swing Dimensions are inches (mm) Hot Air Output (To Cartridge or Tank) COMPLETE Lighted Switch (Amber) ERROR Lighted Switch (Red) 24-1/8 (613) Top View Moist Air Intake (From Cartridge or Tank) 45 (1143) Power Receptacle With ON/OFF Switch Process s Air Inlet Exhaust Front View Side View 8-3/4 (222) 45 (1143) Dry Processed Air Outlet (From Dryer Regenerator) 20-7/64 (511) Process Air Inlet (To Dryer Regenerator) Desiccant Fill/Drain Port 16-3/4 (1143) 18-5/8 (473) 16-1/8 (410) Tank Front View 15-1/2 (393) Tank Side View Cartridge Rear View Cartridge Side View 8

Refer to the Following Equipment Drawing for Installation Details Equipment Drawing Part Number Equipment Drawing Title 146668-820 Equipment Drawing, Circulation Module Dimensions are inches (mm) Dimensions are typical drawing is not to scale. 24-1/8 ± 1/4 (613 ± 6) Top View 25-1/4 ± 1/4 (643 ± 6) Circulation Outlet Biodecontaminant P1 Power Supply Cable RTD1 Cable Side View Front View 9

Refer to the Following Equipment Drawing for Installation Details Equipment Drawing Part Number Equipment Drawing Title 146668-822 Equipment Drawing, Auxiliary Aerator Dimensions are inches (mm) 13-1/8 ± 1/4 (335 ± 6) Dimensions are typical drawing is not to scale. 12-1/4 ± 1/4 (308 ± 6) NOTE: Room Air Inlet and Exhaust Air Outlet MUST Remain Free From Obstructions. End View Cable From VHP1000-ARD Biodecontamination Unit or Contactor Unit Attaches Here (P5/P9) Power Input Plug Power ON/OFF Side View 10

Refer to the Following Equipment Drawing for Installation Details Equipment Drawing Part Number Equipment Drawing Title 146668-823 Equipment Drawing, Contactor Module 146668-824 Equipment Drawing, Sensor Box Dimensions Are are inches typical (mm) drawing is not to scale. Dimensions are inches (mm) 9 (227) Door Closed 10 (254) Door Open Contact Unit Top View 8-3/4 (223) Door Swing 9-1/8 (232) Door Closed Sensing Unit Top View Power Supply Cord Contact Unit Front View RTD Humidity Sensing Probe Sensing Unit Front H 2 O 2 Sensing Probe Cable From VHP 1000-ARD 0-A Biodecontamination nation Unit Attaches Here e( (P5/P9) P9) Cable From VHP 1000-ARD Biodecontamination Unit Attaches Here (P8) Cable To Auxiliary Aeration Unit (P5/P9) Power Inlet 17-1/4 (438) Cable To Additional Sensing Unit (P6) 17-1/4 (438) 8-1/4 (211) Contact Unit Side View 8-1/4 (211) Sensing Unit Side View 11

For Further Information, contact: STERIS Corporation 5960 Heisley Road Mentor, OH 44060-1834 USA 440-354-2600 800-444-9009 www.steris.com SD840 2007, STERIS Corporation. All rights reserved. (11/01/07) This document is intended for the exclusive use of STERIS customers, including architects or designers. Reproduction in whole or in part by any party other than a customer is prohibited.