2ABQIVHPX10VHP X10 Biodecontamination Unit

OPERATOR MANUAL X10 ™ Biodecontamination Unit (TEAM)10087252 i IntroductionOperator Manual10087252 A 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. STERIS is committed to ensuring your continued satisfaction. This manual contains important information on proper use and maintenance of the X10 ™ Biodecontamination Unit. All personnel involved in the use and maintenance of this equipment must carefully review and comply with the S AFETY PRECAUTIONS and instructions contained in this manual and the Vaprox ® 59 Hydrogen Peroxide Sterilant Safety Data Sheet (SDS), product label and package insert. These instructions are important to protect the health and safety of personnel operating the X10 Biodecontamination Unit and should be retained in a conveniently accessible area for quick reference. Complete instructions for uncrating and installing this unit, as well as equipment drawings, have been furnished. If missing, contact STERIS Life Sciences for replacement copies, giving the serial, equipment and model numbers of the Biodecontamination Unit. NOTE: Refer to S ECTION2 of this manual for a listing of Terms, Definitions and Symbols that may appear in this manual or on your equipment. Advisory A listing of the SAFETY PRECAUTIONS to be observed when operating and servicing this X10 Biodecontamination Unit and/or handling the Sterilant is found in S ECTION1 of this manual or on the container label. Do not operate or service 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 Regulations for the specific uses described in this manual. The X10 Biodecontamination Unit must be used only on Enclosures (refer to S ECTION2.1, TERMS AND DEFINITIONS) that have been pre-cleaned and dried per facility process and current protocols. Please refer to the Vaprox 59 Hydrogen Peroxide Sterilant package insert for additional information and application instructions. IMPORTANT: A listing of the SAFETY PRECAUTIONS to be observed when operating and servicing this equipment and/or handling Vaprox 59 Hydrogen Peroxide Sterilant can be found in SECTION1 of this manual. Do not operate or service the equipment or handle the Sterilant until you have been trained and certified on this information as well as the information on the Vaprox 59 Hydrogen Peroxide Sterilant product label and package insert. IMPORTANT: Please refer to SECTION2.1, TERMS AND DEFINITIONS, for a list of terminology used in 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. ii 10087252Operator ManualIntroduction 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 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. The X10 Biodecontamination Unit is designed for mobile Biodecontamination of clean, dry, sealed Enclosures (refer to S ECTION2.1, TERMS AND DEFINITIONS) of three, four, five and six foot widths with corresponding internal volumes from 15.6 - 31.2 ft 3 (.44 - .88 m 3 ) using STERIS’s patented VHP ® Process Technology and using Vaprox 59 Hydrogen Peroxide Sterilant. Uses other than as specified and described in this manual are not recommended and may not be effective or safe in operating the Biodecontamination Unit. Consult this manual or STERIS Life Sciences for further information. The Biodecontamination Unit utilizes specially designed disposable 70 mL Cups* of Vaprox 59 Hydrogen Peroxide Sterilant. *Available separately for purchase. Introduction The STERIS X10 Biodecontamination Unit offers fast, economical Biodecontamination of Enclosures (refer to S ECTION2.1, TERMS AND DEFINITIONS). The Biodecontamination Unit uses STERIS's patented VHP Process Technology. This 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 X10 features X-Phase hardware technology and VaproxLink software technology. X-Phase hardware technology features a rotating cylinder design that enables heating, dehumidification, conditioning, Biodecontamination and aeration for an All-In-One unit design while VaproxLink software technology automatically identifies Vaprox 59 Hydrogen Peroxide Sterilant Cup and verifies expiration date. 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 internal cabinet volume up to 31.2 ft 3 (.88 m 3 ). 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 Science…

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6-2 10087252Operator ManualSupplemental Information ❑Biodecontamination Unit components are properly positioned in relation to Enclosure (refer to SECTION2.1, TERMS AND DEFINITIONS) being processed, as described in SECTION3.2, OPERATION. ❑The X10 Biodecontamination Unit components are properly connected (refer to Figure 3-4 or Figure 3-6). ❑A Vaprox ® 59 Hydrogen Peroxide Sterilant Cup is in place; if a Cup is not in place or is empty, install a new Cup as described in S ECTION6.6, STERILANT CUP INSTALLATION AND REMOVAL. ❑Desiccant cartridge assembly is properly inserted (see S ECTION6.7, DESICCANT INSTALLATION AND REMOVAL). 6.2 Technical Data 6.2.1 Overall Size (W x H x D)28 x 22 x 15" (711 x 559 x 381 mm) 6.2.2 Weight68 lb (31 kg) 6.2.3 Electric Requirements120 Vac, 50/60 Hz, 12 A, 1 Ph 230 Vac, 50/60 Hz, 7 A, 1 Ph 6.2.4 Environmental Conditions Temperature: 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: 2 Installation Category (Overvoltage Category): II IP67 Rating Closed; IP20 Rating Open IC Number: IC: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. Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement. 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 the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against Changes or modifications not expressly approved by STERIS Life Sciences could void the user’s authority to operate the equipment. 6-3 Supplemental InformationOperator Manual10087252 harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct interference at his own expense. 6.3 Hydrogen Peroxide Biodecontamination Figure 6-1. X10 Biodecontamination Unit The X10 Biodecontamination Unit (see Figure 6-1) provides a simple and reliable method for Biodecontaminating pre-cleaned, dry sealable Enclosures (refer to S ECTION2.1, TERMS AND DEFINITIONS). Effective use of H 2 O 2 vapor for Biodecontamination requires adequate concentration and exposure time. The X10 Biodecontamination Unit typically uses a closed loop process (refer to S ECTION 3, OPERATING INSTRUCTIONS) utilizing air as a carrier to deliver Vaprox 59 Hydrogen Peroxide Sterilant vapor to the exposed surfaces inside a pre-cleaned, dry, sealed Enclosure (refer to S ECTION2.1, TERMS AND DEFINITIONS). This closed loop process allows the Biodecontamination process to take place at atmospheric conditions. Because Biodecontamination relies only on the contact of Sterilant with exposed surfaces, the transfer of heat and moisture required by steam processes is not necessary. H 2 O 2 vapor is continuously injected for the required exposure time to achieve Biodecontamination. The Sterilant evacuated from the Enclosure in a closed loop operation is catalytically converted into water vapor and oxygen. . 6.4 Biodecontamination Cycle The properly installed X10 Biodecontamination Unit outside the Enclosure (refer to SECTION2.1, 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 solution of 59% (Vaprox 59 Hydrogen Peroxide Sterilant) hydrogen peroxide vapor is atomized and a high velocity air stream disperses it throughout Enclosure. Relative humidity and temperature sensor measurements ensure the vapor does not condense on internal Enclosure surfaces. 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. V aprox 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 H 2 O 2 other than V aprox 59 H 2 O 2 could impair equipment operation, result in costly repairs, result in an ineffective Biodecontamination Cycle, violate federal law and void the equipment warranty.

Steris Corporation VHP X10 EXTERNAL PHOTOGRAPH(S) Page 1 of 3 Steris Corporation VHP X10 EXTERNAL PHOTOGRAPH(S) Page 2 of 3 Steris Corporation VHP X10 EXTERNAL PHOTOGRAPH(S) Page 3 of 3

Pro/ENGINEER DWG. - B SIZE THIRD ANGLE PROJECTION CorporationMentor, Ohio R.093.015 2.500±.015 3.625±.015 REVISIONS APPROVEDDATEDESCRIPTIONLTR -----------------RELEASE IN PLM A A 10038093 EST. WEIGHT SHEET 1 of 1 SCALE 2.000 REV.PART NO. B This document contains confidential and proprietary information of STERIS Corporation. Neither this document nor the information herein are to be reproduced, distributed, used or disclosed, either in part or in whole, except as specifically authorized by STERIS Corporation SEE NOTE COLOR SIZE SEE NOTE FINISHDATEREVISION SILVER POLYESTER MATERIALDATEAPPROVED BY DATA PLATA, FCC AND C1 MARK DATECHECKED BY UNLESS OTHERWISE SPECIFIED DIMENSIONS ARE IN INCHES TOLERANCES ARE: FRACTIONS DECIMALS ANGLES 1/32 .X .015 0.5 .XX .010 .XXX .005 LABEL, ENGLISH,DOMESTIC, 1/23/14Vince Vlach TITLEDATEDRAWN NOTES: 1. ARTWORK FILE:10038093.AI 2. MATERIAL: .002 SILVER POLYESTER 3: COLORS: TEXT/GRAPHICS = BLACK/SILVER BACKGROUND = SILVER/BLACK 4. PRINTING - ON SURFACE 5. LAMINATION - .001 COMPUCAL II 6. BACKING - STANDARD ADHESIVE 7. HOLES - NONE Development VersionUser NameRoleVoteEvent Date A.5Dale KitchenReviewerApproved2014-02-10 09:13:16 EST A.5Leight, Steven LeightApproverApproved2014-02-10 09:18:52 EST

STERIS VHP X10 nameplate label location on door.

Steris Corporation VHP X10 Page 1 of 6 INTERNAL PHOTOGRAPH(S) Steris Corporation VHP X10 Page 2 of 6 INTERNAL PHOTOGRAPH(S) Steris Corporation VHP X10 Page 3 of 6 INTERNAL PHOTOGRAPH(S) Steris Corporation VHP X10 Page 4 of 6 INTERNAL PHOTOGRAPH(S) Steris Corporation VHP X10 Page 5 of 6 INTERNAL PHOTOGRAPH(S) Steris Corporation VHP X10 Page 6 of 6 INTERNAL PHOTOGRAPH(S)

091213 Report Number: F2LQ5823-02E Rev. 2 Page 1 of 24 Issue Date: Feb. 12, 2014 F2 Labs 16740 Peters Road Middlefield, Ohio 44062 United States of America www.f2labs.com CERTIFICATION TEST REPORT Manufacturer: Steris Corporation 5960 Heisley Road Mentor, Ohio 44060 United States of America Applicant: Same As Above Product: Biodecontamination System Model: VHP X10 FCC ID: 2ABQIVHPX10 Testing Commenced: Nov. 7, 2013 Testing Ended: Nov. 15, 2013 Summary of Test Results: Page 4 Standards: • FCC Part 15 Subpart C, Section 15.225, 15.207, 15.209 Evaluation Conducted by: Ken Littell, EMC Tech. Mgr. Report Reviewed by: Wendy Fuster, President F2 Labs F2 Labs 26501 Ridge Road 16740 Peters Road Damascus, MD 20872 Middlefield, OH 44062 Ph 301.253.4500 Ph 440.632.5541 Fax 301.253.5179 Fax 440.632.5542 This test report may be reproduced in full; partial reproduction only may be made with the written consent of F2 Labs. The results in this report apply only to the equipment tested. Order Number: F2LQ5823 Client: Steris Corporation Model: VHP X10 091213 Report Number: F2LQ5823-02E Rev. 2 Page 2 of 24 Issue Date: Feb. 12, 2014 7 TABLE OF CONTENTS Section Title Page 1 ADMINISTRATIVE INFORMATION 3 2 SUMMARY OF TEST RESULTS/MODIFICATIONS 4 3 ENGINEERING STATEMENT 5 4 EUT INFORMATION AND DATA 5 5 LIST OF MEASUREMENT INSTRUMENTATION 6 6 FCC Part 15.225(a)(b)(c)(d) Operation With the Band 13.110-14.10 MHz 7 7 FCC Part 15.207 Conducted Emissions 12 8 FCC Part 15.225(e) Frequency Stability 15 9 FCC Part 15.215(c) Occupied Bandwidth 20 10 Photos/Exhibits – Product Photos, Test Setups 21 Order Number: F2LQ5823 Client: Steris Corporation Model: VHP X10 091213 Report Number: F2LQ5823-02E Rev. 2 Page 3 of 24 Issue Date: Feb. 12, 2014 1 ADMINISTRATIVE INFORMATION 1.1 Measurement Location: F2 Labs in Middlefield, Ohio. Site description and attenuation data are on file with the FCC's Sampling and Measurement Branch at the FCC Laboratory in Columbia, MD. 1.2 Measurement Procedure: All measurements were performed according to the 2003 version of ANSI C63.4 and recommended FCC procedure of measurement of DTS operating under Section 15.225. A list of the measurement equipment can be found in Section 6. 1.3 Uncertainty Budget: Radiated Emissions • Combined Uncertainty (+ or -) 2.67 dB • Expanded Uncertainty (+ or -) 5.35 dB Conducted Emissions • Combined Uncertainty (+ or -) 1.88 dB • Expanded Uncertainty (+ or -) 3.75 dB This uncertainty represents an expanded uncertainty expressed at approximately the 95% confidence level using a coverage factor of k=2. 1.4 Document History Document Number Description Issue Date Approved By F2LQ5823-02E First Issue Nov. 22, 2013 W. Fuster F2LQ5823-02E Rev. 1 Revision of FCC ID Jan. 21, 2014 W. Fuster F2LQ5823-02E Rev. 2 Update of section 1.3; addition of findings in section 8.1; replacement of frequency stability plots in section 8.2; addition of occupied bandwidth data and additional radiated spurs data. Feb. 12, 2014 W. Fuster Order Number: F2LQ5823 Client: Steris Corporation Model: VHP X10 091213 Report Number: F2LQ5823-02E Rev. 2 Page 4 of 24 Issue Date: Feb. 12, 2014 2 SUMMARY OF TEST RESULTS Test Name Standard(s) Results Operation Within the Band 13.110-14.010 MHz FCC Part 15 Subpart C 15.225(a)(b)(c)(d) Complies AC Mains Conducted Emissions FCC Part 15 Subpart C 15.207 Complies Radiated Emissions FCC Part 15 Subpart C 15.209 Complies Frequency Stability FCC Part 15 Subpart C 15.225(e) Complies Occupied Bandwidth FCC Part 15 Subpart C 15.215(c) Complies Modifications Made to the Equipment None Order Number: F2LQ5823 Client: Steris Corporation Model: VHP X10 091213 Report Number: F2LQ5823-02E Rev. 2 Page 5 of 24 Issue Date: Feb. 12, 2014 3 ENGINEERING STATEMENT This report has been prepared on behalf of Steris Corporation to provide documentation for the testing described herein. This equipment has been tested and found to comply with Part 15.225 of the FCC Rules using ANSI C63.4 2003 and Part 15 standards. The test results found in this test report relate only to the items tested. 4 EUT INFORMATION AND DATA 4.1 Equipment Under Test: Product: Biodecontamination System Model: VHP X10 Serial No.: None Specified FCC ID: 2ABQIVHPX10 4.2 Trade Name: Steris Corporation 4.3 Power Supply: 230VAC, 60Hz 4.4 Applicable Rules: CFR 47, Part 15.225, subpart C 4.5 Equipment Category: RFID 4.6 Antenna: Internal Chip antenna 4.7 Accessories: N/A 4.8 Test Item Condition: The equipment to be tested was received in good condition. 4.9 Testing Algorithm: The EUT was configured to constantly scan a passive tag internal to the EUT. For radiated emissions tests, a semi-anechoic chamber and an OATS were used. For the conducted emissions test on the AC Mains power cord, a CISPR 16 approved LISN set was used. The highest emissions were recorded in the data tables. Order Number: F2LQ5823 Client: Steris Corporation Model: VHP X10 091213 Report Number: F2LQ5823-02E Rev. 2 Page 6 of 24 Issue Date: Feb. 12, 2014 5 LIST OF MEASUREMENT INSTRUMENTATION Equipment Type Asset Number Manufacturer Model Serial Number Calibration Due Date Shield Room 0175 Ray Proof N/A 11645 Oct. 28, 2014 Temp/Hum. Recorder CL137 Extech RH520 CH16992 Apr. 17, 2014 OATS-3m CL017 Compliance Labs N/A 001 Dec. 13, 2014 Spectrum Analyzer CL147 Agilent E7402A MY45101241 Oct. 24, 2014 Spectrum Analyzer CL138 Agilent Technologies E4407B US41192779 Oct. 29, 2014 Receiver CL151 Rohde & Schwarz ESU40 100319 Oct. 30, 2014 Antenna 1-Chamber 0142 ETS/EMCO 3142B 9811-1330 Verified Antenna 2-OATS 0105 Sunol Sciences JB1 A101101 May 7, 2015 Pre-Amplifier 0139 Hewlett Packard 83006A 3104A00500 Feb. 20, 2014 Active 18” Loop Antenna CL082 A.H. Systems, Inc. SAS-562B 241 Sept. 6, 2014 LISN 1 0149 Solar 8028-50-TS-24- BNC 1130 Oct. 18, 2016 LISN 2 0147 Solar 8028-50-TS-24- BNC 1128 Oct. 28, 2016 Order Number: F2LQ5823 Client: Steris Corporation Model: VHP X10 091213 Report Number: F2LQ5823-02E Rev. 2 Page 7 of 24 Issue Date: Feb. 12, 2014 6 FCC PART 15.225(a)(b…

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Steris Corporation VHP X10 TEST SETUP PHOTOGRAPHS Page 1 of 4 Steris Corporation VHP X10 TEST SETUP PHOTOGRAPHS Page 2 of 4 Steris Corporation VHP X10 TEST SETUP PHOTOGRAPHS Page 3 of 4 Steris Corporation VHP X10 TEST SETUP PHOTOGRAPHS Page 4 of 4