AXJ02532480RFID

STERRAD ® 100NX ® Sterilization System User’s Guide Ref 99994 M-99994_03 May 2014 DRAFT STERRAD ® 100NX ® Sterilization System User’s Guide 1-888-STERRAD ASP U.S.A. Professional Services ASP International 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 ©. 2008-2014 Division of Ethicon. All rights reserved. STERRAD ® , CYCLESURE ® , SEALSURE ® , APTIMAX ® and 100NX ® are registered trademarks 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 STERRAD ® 100NX ® User’s Guide1 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. Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Personal Safety and First Aid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Personal Protective Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Device Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Warnings, Cautions, and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Chapter 3. Load Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Load Weight Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Cycles and Materials Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Recommended Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Thermoplastics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Thermoplastic Elastomers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Thermosetting Elastomers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Glass . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Metal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Items Not To Be Processed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Do Not Process in the EXPRESS Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Do Not Process in the DUO Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Guidelines for Preparing Items to Be Sterilized . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Cleaning, Rinsing, and Drying . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Packaging and Loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Instrument Trays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Tray Mats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Chemical Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Special Considerations for Flexible Endoscopes . . . . . . . . . . . . . . . . . . . . . . . . 29 DRAFT 2STERRAD ® 100NX ® User’s Guide Chapter 4. Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Before You Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Start and Warm-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Biological Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Login . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Entering Load Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Enter Load Item Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Cycle Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .…

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33 Technology Drive ● Irvine, CA ● 92618 ● [Phone] 800.595.0200 ● [Fax] 949.450.6855 AD-110128-01-US_A Date: 05/19/2014 TUV SUD BABT TCB Octagon House, Segensworth Road, Fareham, Hampshire, PO15 5RL MODEL #:02-53248-0 FCC ID: AXJ02532480 IC ID: 10207A-02532480 Dear Sir or Madam, Please advise that the User Manual is still going through review process for the 02-53248-0. The final revision will be provided to TUV SUD BABT once it is completed. Sincerely, Company Officer: Nancy Chu Telephone Number: 1-949-453-6435 Email: [email protected]

FCC ID AXJ02532480 IC: 11003A-02532480 EUT Picture showing RFID Antenna inside the EUT (RFID module inside the Controller box) Front Panel of EUT where STERRAD®100NX™ Cassette is loaded and verified by the RFID system

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. Model: 02-53248-0 108707-02 FCC ID: AXJ02532480 IC: 10207A-02532480 DATE: May 30, 2014 PRODUCT: STERRAD ® 100NX ® Sterilizer CODE: 10104 PRODUCT DESCRIPTION: RFID Label LANGUAGES: English SIZE: 70mm x 20mm COLORS: Black and PMS 325 (Teal) PART NUMBER: 108707-02

Stérilisateur STERRAD ® 100NX ® Ce dispositif médical est conforme aux règles décrites dans la partie 15 de la FCC (Federal Communications Commission). L’opération est soumise aux deux conditions suivantes: (1) Ce dispositif médical ne peut pas causer l'interférence nuisible, and (2) Ce dispositif doit accepter n'importe quelle interférence reçue, y compris l'interférence qui peut causer une opération non désirée. Model: 02-53248-0 108708-02 FCC ID: AXJ02532480 IC: 10207A-02532480 DATE: May 30, 2014 PRODUCT: STERRAD ® 100NX ® Sterilizer CODE: 10104 PRODUCT DESCRIPTION: RFID Label LANGUAGES: French SIZE: 70mm x 20mm COLORS: Black and PMS 325 (Teal) PART NUMBER: 108708-02

TÜV SÜD AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 FAX: 858 546 0364 May 08, 2014 TUV SUD BABT Octagon House, Concorde Way Segensworth Rd N, Fareham PO15 5RL Attention: Director of Certification RE: Analysis of RF Exposure for Portable and Mobile use per KDB 447498 D01 Mobile Portable RF Exposure v05r02 IC: 10207A-02532480 FCC ID: AXJ02532480 Mobile MPE Calculation using a 20cm separation distance: Using Power Density formula: S= PG 4πR 2 where: S = power density P = power input to the antenna G = power gain of the antenna in the direction of interest relative to isotropic R = distance to the center of radiation of the antenna Measured radiated level @ 3 meters 36.5 (dBμV/m) Maximum peak output power –Radiated 0.0000000013 (Watt) Antenna gain (typical): 0 (dBi) Maximum antenna gain: 1 (numeric) Prediction distance: 20 (cm) Prediction frequency: 13.56 (MHz) MPE limit for uncontrolled exposure at prediction frequency: 0.97893 (mW/cm2) Power density at prediction frequency: 0.0000000003 (mW/cm2) Sincerely, Ferdie S. Custodio Name Authorized Signatory Title: Senior EMC/Wireless Test Engineer

Report No. SC1404190A May 2014 America Report On Radio Testing of the Advanced Sterilization Products Sterrad 100NX 02-53248-0 Low-Temperature Sterilization System FCC Part 15 Subpart C §15.225 IC RSS-210 Issue 8 December 2010 FCC ID AXJ02532480 IC: 10207A-02532480 Report No. SC1404190A Page 2 of 48 TÜV SÜD AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 FAX: 858 546 0364 REPORT ON TEST REPORT NUMBER REPORT DATE Radio Testing of the Advanced Sterilization Products Low-Temperature Sterilization System SC1404190A May 2014 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 May 08, 2014 FCC ID AXJ02532480 IC: 10207A-02532480 Report No. SC1404190A Page 3 of 48 TÜV SÜD AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 FAX: 858 546 0364 Revision History SC1404190A Advanced Sterilization Products Sterrad 100NX Low-Temperature Sterilization System DATE OLD REVISION NEW REVISION REASON PAGES AFFECTED APPROVED BY 05/08/2014 Initial Release Chip Fleury FCC ID AXJ02532480 IC: 10207A-02532480 Report No. SC1404190A Page 4 of 48 TÜV SÜD AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 FAX: 858 546 0364 CONTENTS Section Page No 1 REPORT SUMMARY ............................................................................................................................... 5 1.1 Introduction ................................................................................................................................................ 6 1.2 Brief Summary Of Results ........................................................................................................................... 7 1.3 Product Information ................................................................................................................................... 8 1.4 EUT Test Configuration ............................................................................................................................. 11 1.5 Deviations From The Standard ................................................................................................................. 12 1.6 Modification Record ................................................................................................................................. 12 1.7 Test Methodology ..................................................................................................................................... 12 1.8 Test Facility Location ................................................................................................................................. 12 1.9 Test Facility Registration ........................................................................................................................... 12 2 TEST DETAILS ...................................................................................................................................... 14 2.1 Frequency Stability ................................................................................................................................... 15 2.2 20 dB Bandwidth ....................................................................................................................................... 17 2.3 99% Emission Bandwidth .......................................................................................................................... 19 2.4 Emission Mask .......................................................................................................................................... 21 2.5 Spurious Radiated Emissions .................................................................................................................... 24 2.6 Conducted Emissions ................................................................................................................................ 35 3 TEST EQUIPMENT USED ...................................................................................................................... 40 3.1 Test Equipment Used ................................................................................................................................ 41 3.2 Measurement Uncertainty ....................................................................................................................... 42 4 DIAGRAM OF TEST SETUP ................................................................................................................... 43 4.1 Test Setup Diagram (Emission Mask) ........................................................................................................ 44 4.2 Test Setup Diagram (Radiated Emissions 30 To 1000MHz) ...................................................................... 45 4.3 Test Setup Diagram (Conducted Emissions) ............................................................................................. 46 5 ACCREDITATION, DISCLAIMERS AND COPYRIGHT ............................................................................... 47 5.1 Accreditation, Disclaimers and Copyright ................................................................................................. 48 FCC ID AXJ02532480 IC: 10207A-02532480 Report No. SC1404190A Page 5 of 48 TÜV SÜD AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 FAX: 858 546 0364 SECTION 1 REPORT SUMMARY Radio Testing of the Advanced Sterilization Products Low-Temperature Sterilization System FCC ID AXJ02532480 IC: 10207A-02532480 Report No. SC1404190A Page 6 of 48 TÜV SÜD AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 FAX: 858 546 0364 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 §15.2…

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FCC ID AXJ02532480 IC: 11003A-02532480 Radiated Emissions Test Setup (below 30MHz) Radiated Emissions Test Setup (below 1GHz) Antenna Conducted Port Test Setup Antenna Conducted Port Test Setup