AXJ100NXRFIDLow temperature sterilizer with RFID

STERRAD ® 100NX ® Sterilization System User’s Guide Ref 99994 M-99994_02 April 2012 DRAFT STERRAD ® 100NX ® Sterilization System User’s Guide 1-888-STERRAD ASP U.S.A. Professional Services ASP Insternational 949-581-5799 Please visit www.aspjj.com For warranty information, please visit our website or contact ASP Professional Services. ASP International Customer Support; call your local ASP Representative) ©. 2008-2012 Division of Ethicon. All rights reserved. STERRAD ® is a registered trademark of Advanced Sterilization Products (ASP). Teflon ® , Delrin ® , and Tyvek ® are registered trademarks of E.I. du Pont de Nemours and Company. Radel ® is a registered trademark of Solvay SA. Kraton ® is a registered trademark of Kraton Polymers LLC. Santoprene™ is a trademark of ExxonMobil Corporation. Ultem ® is a registered trademark of SABIC. da Vinci ® is a registered trademark of Intuitive Surgical, Inc. Other products mentioned in this publication are trademarked by their respective owners. Please note: the screen displays shown in this guide are for reference only. The actual displays on your system may be slightly different depending on your system’s configuration and software revision. Reproduction, adaptation, or translation of this publication without prior written permission is prohibited. Printed in the U.S.A. DRAFT Contents Chapter 1. Introduction 5 How to Use This Guide 5 Intended Use 5 The STERRAD ® Sterilization Process 6 If You Have Questions 6 Chapter 2. Load Preparation 7 Load Weight Requirements 7 Cycles and Materials Processing 10 Recommended Materials 14 Thermoplastics 14 Thermoplastic Elastomers 14 Thermosetting Elastomers 15 Glass 15 Metal 15 Items Not To Be Processed 15 Do Not Process in the EXPRESS Cycle 16 Do Not Process in the DUO Cycle 16 Guidelines for Preparing Items to Be Sterilized 17 Cleaning, Rinsing, and Drying 17 Packaging and Loading 19 Instrument Trays 19 Tray Mats 19 Packaging 19 Loading 20 Chemical Indicators 21 Special Considerations for Flexible Endoscopes 21 Chapter 3. Operation 23 Before You Start 23 Start and Warm-up 23 Biological Indicators 23 Login 24 Entering Load Information 25 Enter Load Item Data 25 Cycle Notes 26 Loading the Chamber 28 DRAFT Selecting and Starting a Cycle 32 System Ready Screen 33 Inserting a Cassette 33 Cycle in Progress 34 Canceling a Cycle 35 Cycle Completed 37 Processing a Sterilized Load 38 Inspecting Chemical Indicators 38 Processing Biological Indicators 38 Chapter 4. Troubleshooting 41 Running Diagnostics 41 System Message Table 42 Temperature Messages 42 Messages Not In This Table 42 Call Your ASP Representative 46 Chapter 5. Sterilizer Overview 47 Sterilizer Cycles 47 Sterilizer Features 48 Cassette 49 Cassette Disposal Box 50 Touch Screen and Speaker 50 Chamber 51 Printer 52 Touch Screen Data Entry 53 Chapter 6. Maintenance 55 Automatic Maintenance 55 Automatic Lamp Adjustment 55 Manual Maintenance 56 Disposing of Cassettes 56 Removing a Cassette Disposal Box 57 Replacing the Printer Paper 58 Cleaning the Sterilizer Exterior 61 Cleaning the Hydrogen Peroxide Monitor Detector Lens 62 PCMCIA Card Handling and Replacement 63 Data Transfer Using a Memory Stick 64 Rebooting the System 65 Sterilizer Disposal 65 DRAFT Chapter 7. Reports and Files 67 Displayed Reports 67 Cycle History 67 Printed Reports 69 Short Report 69 Parametric Report 69 Long Report 69 Chapter 8. Access Levels and Supervisor Tasks 71 Overview 71 Access Levels 71 Additional Utilities Menu 72 Date and Time Settings 73 Set Date 74 Set Time 74 Time Zone 74 Date Format 74 Time Format 74 Cancel/Done 74 System Configuration 75 Access Control Option 75 IMS 75 Vacuum Units 75 Load Data Entry Option 76 Load Removal Option 76 Notepad Option 76 Network Option 76 Alarm Volume 76 Backlight Conservation (Minutes) 76 Language Selection 76 Sterilizer Settings 77 Printer Settings 78 Transfer Settings 79 Cancel/Done 79 User Administration 80 Add User 81 Modify User 82 Upload User Data 83 Steps to Upload a User Database 84 Cassette Functions 85 Dispose Cassette 86 Peroxide Clearance 87 Network 88 Diagnostics 88 Diagnostic Tests 89 Service Functions 89 DRAFT File Management 90 Calibration Files 90 Diagnostic Files 90 Upload File 91 Input/Output Doors 92 Product Options 92 Appendix A. Safety Information 95 Personal Safety and First Aid 95 Personal Protective Equipment 97 Device Safety 97 Warnings, Cautions, and Notes 100 Symbols 101 Appendix B. Consumables, Accessories, and Additional Parts 103 Appendix C. Sterilizer Specifications 105 DRAFT Introduction 1 STERRAD ® 100NX ® User’s Guide5 Chapter 1. Introduction How to Use This Guide If you are a STERRAD ® 100NX ® Sterilizer operator, you must read the “Safety Information” appendix and the “Introduction,” “Load Preparation,” and “Operation” chapters prior to operating the sterilizer. This “Introduction” explains the features and parts of the sterilizer. “Load Preparation” explains how to prepare and package instruments for processing. “Operation” explains how to operate the sterilizer and obtain optimal results. If you are a supervisor overseeing the STERRAD ® 100NX ® Sterilizer, you should read the entire user’s guide and pay particular attention to the chapter featuring “Access Levels and Supervisor Level Tasks.” This chapter describes tasks and options that are only available through “Supervisor Level” access. Intended Use The STERRAD ® 100NX ® Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD ® 100NX ® Process to inactivate microorganisms on a broad range of medical devices and surgical instruments. When used as directed by the instructions in this user’s guide, the STERRAD ® 100NX ® Sterilization System will sterilize both metal and nonmetal medical devices at low temperatures. Please review “How to Determine What Can Be Sterilized in the STERRAD ® 100NX® Sterilizer” in the “Load Preparation” chapter along with the cycle information to make sure you follow the directions for proc…

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INfinity 110 Evaluation Kit USER’S GUIDE V1.0 July 20, 2009 © Copyright 2009 Sirit, Inc. All Rights Reserved. Disclaimer and Limitation of Liability The content of this manual is for information use only and is subject to change without notice. Sirit assumes no responsibility or liability for any errors or inaccuracies that may appear in this publication. No part of this manual may be reproduced in any form or by any means, electronic, mechanical, recording, or otherwise, without the prior written permission of Sirit. Sirit products are not designed, intended, authorized or warranted to be suitable for life support applications or any other life critical applications which could involve potential risk of death, personal injury, property damage, or environmental damage. About Sirit Sirit Inc. designs, develops, manufactures and sells Radio Frequency Identification (RFID) technology. Targeted at a diverse set of markets RFID technology has become a core technology for applications including: electronic toll collection, access control, cashless payment systems, product identification, and supply chain management systems including logistics, warehousing and manufacturing, and asset management. Head Office - Canada 372 Bay Street, Suite 1100 Toronto, Ontario, M5H 2W9 Canada Tel: 416.367.1897 Fax: 416.367.1435 Toll Free: 1.800.498.8760 Email: [email protected] Sirit, Inc. - US 1321 Valwood Parkway, Suite 620 Carrollton, Texas 75006 United States Tel: 972.243.7208 Fax: 972.243.8034 Toll Free: 1.866.338.9586 Web: www.sirit.com Preface INfinity 110 Evaluation Kit i Preface Intended audience This document is intended for those who wish to use INfinity 110 Evaluation Kit with the integrated INfinity 110 Reader. Before attempting to install, configure, and operate this product, you should be familiar with the following: hWindows-based software installation and operation hDevice communication parameters and serial communications hRFID reader configuration including antenna placement and RF hBasic digital input/output control What’s in this guide Evaluation Kit Overview – This chapter provides a brief overview of the INfinity 110 Evaluation Kit hardware and software. E valuation Kit Connections – This chapter describes how to mechanically and electrically install the Evaluation Kit. S mart Label Communicator (SLC) Software Installation – This chapter describes how to install the Microsoft Windows SLC application. Operation – This chapter provides basic instructions for basic operation with the SLC application. S LC – This chapter describes the SLC Graphical User Interface (GUI) and the various functions you can perform with this Microsoft Windows application. C onfiguration and Maintenance – This chapter provides information for configuring the Evaluation Kit. For detailed command information, refer to the INfinity 110 Protocol Reference Guide. T roubleshooting – This chapter provides tips for troubleshooting the Evaluation kit. S pecifications – This chapter detailed mechanical, electrical, and environmental specifications for the Evaluation Kit. S afety Instructions – This chapter provides important safety information about the Evaluation Kit. All users must read this section before installing or operating this Evaluation Kit. Preface ii I Nfinity 110 Evaluation Kit What’s New in this Version Version 1.0 of this User’s Guide is the initial release. Conventions used in this manual The following conventions are used in this manual: Bold courier font indicates code entered by the user (values) within parentheses indicate parameters (values) in italics indicate user defined variables. <n> indicates a variable number used in a function that can apply to several different devices such as antennas or I/O ports. WARNING: Warnings advise the user that a hazardous condition can be created by a particular action that can cause bodily injury or extreme damage to equipment Caution: Cautions advise the user that a condition can be created by a particular action that can cause equipment damage or result in equipment operation that violates regulatory requirements. NOTES Important information and other tips are presented in light blue boxes to the left of the applicable section. Contents I Nfinity 110 Evaluation Kit iii Table of Contents Evaluation Kit Overview ............................................................................................................................... 1 Evaluation Kit .......................................................................................................................................2 Evaluation Kit Software ........................................................................................................................3 Evaluation Kit Connections ......................................................................................................................... 4 Electrical Installation.............................................................................................................................4 Connecting Serial Communications......................................................................................................4 Connecting the Antenna ........................................................................................................................4 Connecting the Power ...........................................................................................................................4 Smart Label Communicator (SLC) Software Installation....................................................................... 5 SLC Installation.....................................................................................................................................5 Lotis Downloader Installation ...............................................................................................................6 Operation .......................................................................................................…

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FCC ID AXJ100NXRFID IC: 10207A‐100NXRFID EUT RFID System inside the EUT Front panel of EUT where STERRAD® 100NX™ Cassette is loaded and verified by the RFID system

33 Technology Drive ● Irvine, CA ● 92618 ● [Phone] 800.595.0200 ● [Fax] 949.581.5997 FCC/IC label location 33 Technology Drive ● Irvine, CA ● 92618 ● [Phone] 800.595.0200 ● [Fax] 949.581.5997 STERRAD ® 100NX ® Label requirements STERRAD® 100NX® Sterilizer 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 received, including interference that may cause undesired operation. FCC ID: AXJ100NXRFID IC: 10207A‐100NXRFID

33 Technology Drive ● Irvine, CA ● 92618 ● [Phone] 800.595.0200 ● [Fax] 949.581.5997 STERRAD® 100NX® RFID CONFIGURATION The RFID Transceiver Assembly resides on the interface board within the metal control enclosure assembly. The RFID Transceiver Assembly interfaces with the RFID antenna board through a coaxial cable. The antenna board is mounted on the delivery system. Peroxide cassettes with an RFID tag are inserted into the delivery system and the system reads and writes to this tag. Control Enclosure Assembly RFID Antenna Board RFID Module (within metal enclosure) Peroxide Cassettes with RFID tag Inserted here Coax attached here Coax routed to antenna board 33 Technology Drive ● Irvine, CA ● 92618 ● [Phone] 800.595.0200 ● [Fax] 949.581.5997 04/19/12 RFID Transceiver Assembly (within the metal enclosure) RFID Transceiver Assembly RFID Antenna Board

Prediction of MPE limit at a given distance Equation from page 18 of OET Bulletin 65, Edition 97-01where: S = power density P = power input to the antennaG = power gain of the antenna in the direction of interest relative to an isotropic radiatorR = distance to the center of radiation of the antenna 57.06 dBuV/m From test report's measured radiated power. 3m 7.1E-04 V =10 ((73-120/20) 1 52448E-07 W = ((V x 3m) 2 )/30 2 4 R PG S   1 . 52448E - 07 W = ((V x 3m) )/30 Maximum peak output power --Radiated: 0.0000002 (W) Antenna gain(typical): 0.00 (dBi) Maximum antenna gain: 1.00 (numeric) Prediction distance: 20.00 (cm) Prediction frequency: 13.56 (MHz) Limit from table below: 1 (mW/cm^2) Power density at prediction frequency: 0.00000003 (mW/cm^2) EUT complies 2 4 R PG S   FCC/LSGAC Local Official’s Guide to RFA LOCAL GOVERNMENT OFFICIAL'S GUIDE TO TRANSMITTING ANTENNA RFEMISSION SAFETY: RULES, PROCEDURES, AND PRACTICAL GUIDANCE

Report No. SC1108039 July 2012 America Report On Radio Testing of the Advanced Sterilization Products Sterrad 100NX Low‐Temperature Sterilization System FCC Part 15 Subpart C §15.225 IC RSS‐210 Issue 8 December 2010 FCC ID AXJ100NXRFID IC: 10207A‐100NXRFID Report No. SC1108039 REPORT ON TEST REPORT NUMBER REPORT DATE Radio Testing of the Advanced Sterilization Products Low‐Temperature Sterilization System SC1108039 July 2012 PREPARED FOR Jim Schechter Staff Engineer (949) 789‐3910 [email protected] PREPARED BY Ferdinand S. Custodio Name Title: EMC/Wireless Test Engineer APPROVED BY Chip R. Fleury Name Authorized Signatory DATED July 03, 2012 FCC ID AXJ100NXRFID IC: 10207A‐100NXRFID Report No. SC1108039 Page 3 of 43 CONTENTS Section Page No 1 REPORT SUMMARY ............................................................................................................................ 4 1.1 Introduction .............................................................................................................................................. 5 1.2 Brief Summary Of Results ......................................................................................................................... 6 1.3 Product Information ................................................................................................................................. 7 1.4 EUT Test Configuration ........................................................................................................................... 10 1.5 Deviations From The Standard ................................................................................................................ 11 1.6 Modification Record ............................................................................................................................... 11 1.7 Test Methodology .................................................................................................................................. 11 1.8 Test Facility ............................................................................................................................................. 11 2 TEST DETAILS .................................................................................................................................... 12 2.1 Frequency Stability ................................................................................................................................. 13 2.2 20 Db Bandwidth .................................................................................................................................... 15 2.3 99% Emission Bandwidth ........................................................................................................................ 17 2.4 Emission Mask ........................................................................................................................................ 19 2.5 Spurious Radiated Emissions .................................................................................................................. 21 2.6 Conducted Emissions .............................................................................................................................. 30 3 TEST EQUIPMENT USED .................................................................................................................... 34 3.1 Test Equipment Used .............................................................................................................................. 35 3.2 Measurement Uncertainty ..................................................................................................................... 36 4 DIAGRAM OF TEST SETUP ................................................................................................................. 37 4.1 Test Setup Diagram (Emission Mask) ...................................................................................................... 38 4.2 Test Setup Diagram (Radiated Emissions 30 To 1000mhz) ...................................................................... 39 4.3 Test Setup Diagram (Radiated Emissions 30 To 1000mhz – Receive Mode/RFID Module + Antenna Verified Stand‐Alone) ............................................................................................................................. 40 4.4 Test Setup Diagram (Conducted Emissions/RFID Module + Antenna Verified Stand‐Alone) ................... 41 5 ACCREDITATION, DISCLAIMERS AND COPYRIGHT .............................................................................. 42 5.1 Accreditation, Disclaimers and Copyright ............................................................................................... 43 FCC ID AXJ100NXRFID IC: 10207A‐100NXRFID Report No. SC1108039 Page 4 of 43 SECTION 1 REPORT SUMMARY Radio Testing of the Advanced Sterilization Products Low‐Temperature Sterilization System FCC ID AXJ100NXRFID IC: 10207A‐100NXRFID Report No. SC1108039 Page 5 of 43 1.1 INTRODUCTION The information contained in this report is intended to show verification of the Advanced Sterilization Products Low‐Temperature Sterilization System to the requirements of FCC Part 15 Subpart C §15.225 and IC RSS‐210 Issue 8 December 2010. Objective To perform Radio Testing to determine the Equipment Under Test's (EUT’s) compliance with the Test Specification, for the series of tests carried out. Manufacturer Advanced Sterilization Products Model Number(s) Sterrad FCC ID Number AXJ100NXRFID IC Number 10207A‐100NXRFID Serial Number(s) 1042070041 Number of Samples Tested 1 Test Specification/Issue/Date  FCC Part 15 Subpart C §15.225 (October 1, 2010).  RSS ‐210 ‐ Licence‐exempt Radio Apparatus (All Frequency Bands): Category I Equipment (Issue 8, December 2010).  RSS‐Gen ‐ General Requirements and Information for the Certification of Radio Apparatus (Issue 3, December 2010). Start of Test November 09, 2011 Finish of Test June 26, 2012 Name of Engineer(s) Ferdinand S. Custodio Kathy MacKenzie …

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FCC ID AXJ100NXRFID IC: 10207A‐100NXRFID Radiated Emissions from 30MHz to 1GHz Fundamental verification using a loop antenna Conducted Antenna Port Measurement Conducted Emission Test Setup (Front) Conducted Emission Test Setup (Back) Frequency Stability Test Setup Frequency Stability/Voltage Variation Test Setup