SB6C408650RFID DOC

ILUMIEN™ OPTIS™ System Instructions for Use Information provided within this Document is subject to change without notice and although believed to be accurate, St. Jude Medical, Inc. and its affiliated companies including without limitation, St. Jude Med- ical System AB (Sweden), assume no responsibility for any errors, omissions or inaccuracies. ©2013 St. Jude Medical, Inc. and its related companies. All rights reserved. Reproduction, adaptation, or translation without prior permission is prohibited, except as allowed under copyright laws. ILUMIEN OPTIS systems are subject to US Patent 8,325,419, GB, FR 0883793, DE 69738291. ILUMIEN, OPTIS, ST. JUDE MEDICAL, LIGHTLAB IMAGING, GOLDEN IMAGE and the color gold are registered or unregistered trademarks of St. Jude Medical, Inc. and its related companies. ILUMIEN OPTIS systems enabled for FFR may also be subject to US Patent 6,565,514. The I LUMIEN OPTIS system software incorporates third party licensed software as described at the follow- ing URL: www.sjmprofessional.com/ilumien-legal-notices St. Jude Medical Coordination Center BVBAAustralian Sponsor: The Corporate VillageSt. Jude Medical Australia Pty Limited Da Vincilaan 11 Box F117 Orion Rd., 1935 Zaventem BelgiumLane Cove NSW 2066 Australia +32 2 774 68 11+61 2 9936 1200 LightLab Imaging, Inc.Phone:+1 800 544 1664 (US) 4 Robbins Road+1 651 490 4410 (Outside US) Westford, MA 01886 USA www.sjm.com Service E-mail: [email protected] Part Number ARTUS100088927 ENGLISH Printed in the U.S.A. 3 / 2013 CAUTION: Federal law restricts this device to sale by or on the order of a Physician licensed by law of the state in which he practices to use or order the use of the device. ILUMIEN OPTIS System Instructions for Useiii SAFETY INFORMATION Please review this manual carefully before using your I LUMIEN OPTIS System, especially the safety infor- mation in Chapter 11 “Safety Information”. Also, especially note Warnings and Cautions shown through- out the manual. WARNINGS Electrical Shock Hazard Do not remove I LUMIEN OPTIS System covers. To avoid electrical shock, use only the power cord sup- plied with the system and connect only to properly grounded wall outlets. See Chapter 2 “System Setup” and Chapter 11 “Safety Information” for electrical safety information. Explosion Hazard Do not operate the I LUMIEN OPTIS System in the presence of flammable anesthetics. Doing so could lead to an explosion. Visible and Invisible Laser Radiation Do not stare into the beam or view the beam directly with optical instruments. Doing so may cause seri- ous eye damage and hazardous radiation exposure. Using These Instructions for Use This manual describes the St. Jude Medical I LUMIEN OPTIS System. In it you will find: •Descriptions of system components and user interface. •Procedures for using the system for both Optical Coherence Tomography (OCT) and Frac- tional Flow Reserve Rate (FFR) procedures. •System safety and cleaning information. •System specifications. iv Conventions Used in These Instructions for Use •These abbreviations and shortened expressions are used throughout this manual. •Software text, and physical button labels are shown in bold type. Examples: the Patient Summary menu, Settings button. •Keyboard keys are shown enclosed in carets. Examples: <Enter>, <Ctrl>, <Tab>. •Warnings, Cautions, and Notes are set apart from other text and appear as shown below. WARNING: Warnings alert the user to the possibility of injury, death, or other serious adverse reactions associated with product use or misuse. CAUTION: Cautions alert the user to the possibility of a problem with the product associated with its use or misuse. Problems can include product malfunctions, product failure, and/or damage to the product or damage to other property, or loss of data. NOTE:Notes provide additional information. Other Instructions for Use Details of the imaging catheter are covered in the Dragonfly Imaging Catheter Instructions for Use pro- vided with the catheters and are not covered in this manual. Details of the PressureWire are covered in the PressureWire Instructions for Use and are not covered in this manual. NOTE:Additionally, this manual does not provide detailed discussion of the sys- tem components, except as they are used with the I LUMIEN OPTIS System. Table Front-1: Instructions for Use Conventions Dialog Box or MenuA window that solicits a user response. Click or Left-clickClick the left mouse button. Double-clickClick the left mouse button twice in quick succession. SelectHighlight a menu item with the mouse or the tab or arrow keys. ILUMIEN OPTIS System Instructions for Usei Contents Figures Tables System Overview Ilumien Optis System Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Ilumien Optis System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Ilumien Optis System Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Ilumien Optis System - Physician Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Ilumien Optis System - Operator Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 Ilumien Optis System - Connector Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6 Ilumien Optis Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 The Drive-motor and Optical Controller (DOC) . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9 The Wi-Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10 Indications for Use and Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12 Warnings (OCT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . …

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Placement Content Label Material: 0.005” Velvet Lexan (Polycarbonate) Adhesive: 3M Adhesive Transfer Tape 9505 *For full details see provided datasheets FCC Label Details 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:SB6C408650 IC:10934A-I01 Model C408650 Trade Name ILUMIEN OPTIS HP INDIGO® OPTIMIZED SUBSTRATES PRODUCT DATA Hanita Coatings I01405L Dura-Go™ substrates are HP Indigo-licensed and were jointly developed by Hanita Coatings, Tekra Corporation and HP Indigo to create the premier product line of film substrates for HP Indigo digital presses. Our proprietary primer coatings provide a number of benefits, including: Reliable, superior ink adhesion High definition of colors Long shelf life, guaranteed to print for one year after purchase when stored at less than 72F and less than 50% relative humidity. The Dura-Go coating is highly resistant to weathering/degradation: Units Test Conditions Weatherability 2 Months Outdoor 24 Months Indoor Dish Washer pass N/A 1.5 hours, top cycle Water and 200 Hours 65% RH at 80F Chemical Resistance 200 Hours Distilled Water at 90F 2 Hours Water + 2% detergent at 150F 24 Hours Ethanol at 75F I01405L is a one side velvet, one side matte transparant polycarbonate film coated on one side. It offers high temperature resistance and excellent dimensional stability. It offers ease of processing for embossing, die cutting, and bending. It is used in applications such as name plates, face plates, overlays, and high performance graphics. 5 mil (125 micron) Velvet / Matte Polycarbonate The application suggestions, specifications and other data described here are based on experience that is believed by Tekra Corporation and Hanita Coatings to be reliable. Because of the characteristics of these products, you should, before using these products in production, perform your own tests to determine to your satisfaction whether these products are acceptable and suitable for your particular purposes under your operation conditions. Any order for these products will be subject to Seller’s terms and conditions of sale. Typical Property Values PropertyASTM Test MethodUnits (USCS)ValueISO Test MethodUnits (SI) Value Mechanical Tensile Strength @YieldASTM D882psi8500ISO 527MPa62 UltimateASTM D882psi9000ISO 527MPa65 Tensile ModulusASTM D882psi300000ISO 527MPa2506 Tensile Elongation at BreakASTM D882%100-157ISO 527%100-154 Gardner Impact Strength at 0.03 in. (0.75 mm)ASTM D3029ft-lb23ISO 6603-1J31 Tear Strength InitiationASTM D1004lb/mil1.4-1.8kN/m245 PropogationASTM D1922g/mil30-55kN/m10-20 Puncture Resistance (Dynatup)ASTM D3763ft-lb9J12 Fold Endurance (MIT) 0.010 inch (0.25 mm)ASTM D2176-69double folds130 0.020 inch (0.50 mm)ASTM D2176-69double folds35 Thermal Coefficient of Thermal ConductivityASTM D5470Btu/hr/ft²/°F/in 1.35W/m°K0.2 Coefficient of Thermal ExpansionASTM E831 (x 10 -5 /°F) 3.2ISO 11359 (x 10 -5 /°C) 5.8 Specific Heat @ 40°F (4 °C)ASTM E1269Btu/lb/°F0.3KJ/Kg-C° 1.25 Glass Transition TemperatureASTM D3417/D3418°F307ISO 11357°C153 Vicat Softening Temperature, BASTM 1525-00 Modified °F323°C160 Heat Deflection Temp. by TMA at 1.8 Mpa°F290ISO 75 Modified°C145 Shrinkage at 302 °F (150 °C)ASTM D1204%1.40%%1.40% Brittleness TemperatureASTM D746°F-211°C-135 Manufacturing Specifications Min./Max. Limit of Nominal Gauge Range 0.008" (0.200mm)± 10% 0.010-0.015" (0.250-0.375 mm)± 5% 0.020" (0.500 mm)± 3% I01405L Data Sheet Page 2

St. Jude Medical Cardiovascular and Ablation Technologies Division 4 Robbins Rd. Westford, MA 01886 Tel: 978 577 3400 Fax: 978 577 3701 Page 1 of 2 Memorandum To: Whom it may concern From: Tal Lachmann CC: Date: 14‐Mar‐2013 Re: RFID Circuitry (13.56MHz Transmitter) The RFID circuitry is split up between 2 PCBs: 14717‐01 & 14717‐03.  14717‐01: This PCB holds the TI TRF7960A device (Multi‐Standard Fully Integrated 13.56‐Mhz RFID Analog Front End And Data‐Framing Reader), along with its supporting circuitry.  14717‐03: This PCB serves as the antenna for the RFID Tx/Rx communication. Below are images of the two boards. Region of RFID Circuitry TI RFID Device (TRF7960A) 13.56 Crystal Connector to 14717‐03 (Antenna PCB) Image 1: 14717‐01 ‐Top Page 2 of 2 Region of RFID Circuitry Image 2: 14717‐01 ‐Bottom Image 3: 14717‐03 ‐ Top Image4: 14717‐03 ‐ Bottom Connector to 14717‐01 (Main RFID PCB) Antenna Loop Antenna Loop

Curtis-Straus LLC is accredited by the American Association for Laboratory Accreditation for the specific scope of accreditation under Certificate Number 1627-01. This report may contain data which is not covered by the A2LA accreditation. ____________________________________________________________ Curtis-Straus LLC, a wholly owned subsidiary of BV CPS One Distribution Center Circle, #1 • •• • Littleton, MA • •• • TEL (978) 486-8880 • •• • FAX (978) 486-8828 page 1 of 15 Test Report Curtis-Straus LLC, a wholly owned subsidiary of BV CPS Report No EL1585-3 Client LightLab Imaging Inc Jeffrey Roberts Address 4 Robbins Road Westford, MA 01886 Phone (978) 577-3472 Item tested ILUMIEN OPTICS system (OCT imaging system) with RFID Controller Standards FCC Part 15 Section 15.225 FCC ID IC SB6C408650 10934A-I01 FRN 0022489843 Test Dates December 15, 2011 through June 28, 2012 Results As detailed within this report Prepared by Tuyen Truong– Compliance Engineer Authorized by Mairaj Hussain – EMC Supervisor Issue Date 3/14/2013 Conditions of Issue This Test Report is issued subject to the conditions stated in the ‘Conditions of Testing’ section on page 14 of this report. ____________________________________________________________ Curtis-Straus LLC, a wholly owned subsidiary of BV CPS One Distribution Center Circle, #1 • •• • Littleton, MA • •• • TEL (978) 486-8880 • •• • FAX (978) 486-8828 page 2 of 15 Contents Summary.................................................................................................................................3 Test Methodology ....................................................................................................................4 Product Tested - Configuration Documentation .......................................................................5 Statement of Conformity ..........................................................................................................6 Test Results ............................................................................................................................7 Fundamental Measurement.....................................................................................................7 Radiated Spurious Emissions ..................................................................................................9 AC Line Conducted Emission Measurements........................................................................12 Frequency Stability Measurements........................................................................................13 Conditions Of Testing ............................................................................................................14 Release Control Record Issue No. Reason for change Date Issued 1 Original Release March 14, 2013 _____________________________________________________________ Curtis-Straus LLC, a wholly owned subsidiary of BV CPS One Distribution Center Circle, #1 • •• • Littleton, MA • •• • TEL (978) 486-8880 • •• • FAX (978) 486-8828 page 3 of 15 Summary On December 15, 2011 we tested the ILUMIEN OPTICS system (OCT imaging system) with RFID controller for compliance with the following requirements: EMC Emissions: • FCC 47 CFR Part 15 for following tests: • Section 15.225 • Section 15.207 - AC Mains Conducted Emission • Section 15.209 – Spurious Radiated Emission This test report supports an application for certification for the RFID portion of the system which operates on 13.56MHz. Release Control Record Issue No. Reason for change Date Issued 1 Original Release March 14, 2013 _____________________________________________________________ Curtis-Straus LLC, a wholly owned subsidiary of BV CPS One Distribution Center Circle, #1 • •• • Littleton, MA • •• • TEL (978) 486-8880 • •• • FAX (978) 486-8828 page 4 of 15 Test Methodology Radiated emission testing was performed according to the procedures specified in ANSI C63.4 (2003). Emissions were maximized by rotating the hand piece containing the radio board. Antenna of radio\ could not be maximized because it is hard wired to the board. RFID controller is part of ILUMIEN OPTICS system medical cart and connects to the cart using an umbilical cable. Device containing the RFID was analyzed for emissions in 3 orthogonal axis. Frequency range investigated: 0.009MHz – 150MHz (for radio part) and up to 17GHz for unintentional digital circuitry. Measurement distance: 0.15 - 30MHz Conducted 0.009 – 30MHz 3m (loop antenna) 30MHz – 1000MHz 3m 1GHz – 17GHz 3m and 1m AC Line conducted emissions testing was performed with a 50Ω/50μH LISN. All readings are peak unless otherwise specified on the respective table. Darin Ursuliak from Lightlab Imaging was present during the testing. The test sample was received in good condition. _____________________________________________________________ Curtis-Straus LLC, a wholly owned subsidiary of BV CPS One Distribution Center Circle, #1 • •• • Littleton, MA • •• • TEL (978) 486-8880 • •• • FAX (978) 486-8828 page 5 of 15 Product Tested - Configuration Documentation EUT Configuration Work Order: L1585 Company: St. Jude Medical Company Address: 4 Robbins Road Westford, MA 01886 Contact: Darin Ursuliak Person Present:David Winston and Victor Grinberg MNPNSN EUT: C8/ILUMIEN OPTIS with RFID Controller---ILUM+ -1106-P1 EUT Description:OCT Imaging System EUT TX Frequency: 13.56MHz EUT Max Frequency: 3.4GHz Support Equipment: MNSN PC Dimension 4100H3NY801 EUT Ports: Port LabelPort TypeNo. of ports No. Populated Cable TypeShieldedFerritesLength Max Length In/Out NEBS Type Unpopulated Reason AC MainAC1All3-wire ACNoNone3m3mindoor VideoVideo1AllDVIYes2-molded2m2mindoor PIU--1AllMini-DINYesNone2m2mindoor Trigger--10not supported NetworkEthernet1AllCat5NoNone5m10mindoor USBSerial1AllUSBYesNone2m2mindoor Software / Operating Mode Description: Performance Criteria: Cardiology UI Development software is running and displaying received FFR waveforms originating from supplied peripheral AO/P…

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Emissions below 30MHz Emissions above 30MHz Emissions above 1GHz CEMI AC mains CEMI AC mains