SB6C408652C8i

OPTIS™ Integrated 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 Medical System AB (Sweden), assume no responsibility for any errors, omissions or inaccuracies. ©2014 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. OPTIS Integrated systems are subject to US Patents 8,412,312, 8,325,419, 6,565,514; 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. The OPTIS I NTEGRATED system software incorporates third party licensed software as described at the following 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:+1 855 478 5833 US Toll-free 4 Robbins Road+1 651 756 5833 International Westford, MA 01886 USA www.sjm.com Service E-mail: [email protected] Part Number ARTUS100109403 ENGLISH Printed in the U.S.A. 4 / 2014 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 O PTIS Integrated System, especially the safety information in Chapter 11 “Safety Information”. Also, especially note Warnings and Cautions shown throughout the manual. WARNINGS Electrical Shock Hazard Do not remove OPTIS I NTEGRATED System covers. To avoid electrical shock, use only the power cord supplied 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 OPTIS I NTEGRATED 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 O PTIS Integrated 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 O PTIS Integrated Sys- tem. 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 or the Select button on the Table Side Controller. Double-clickClick the left mouse button or the Select button on the Table Side Controller twice in quick succession. SelectHighlight a menu item with the mouse or the tab or arrow keys or the Navigation Controller on the Table Side Controller. ILUMIEN OPTIS System Instructions for Usei Contents Figures Tables System Overview Optis Integrated System Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 OPTIS Integrated System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 OPTIS Integrated System Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Optis Integrated System Cabinet and Control Room Components . . . . . . . . 1-4 Optis Integrated System - Mobile Workstation . . . . . . . . . . . . . . . . . . . . . . . 1-5 OPTIS Integrated System Table Side Controller. . . . . . . . . . . . . . . . . . . . . . 1-6 OPTIS Integrated System DOC Holster. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 OPTIS Integrated Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8 The Drive-motor and Optical Controller (DOC) . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10 The Wi-Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11 Indications for Use and Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12 Contraindications . . . . . . . . . . . . . . . . . . . . . . . .…

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C8i PIU2.2 External Pictures

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: SB6C408652 IC: 10934A-IOI1 Model Number: C408652 Trade Name: OPTIS™ Intergrated System BlackCool Gray 3 (8c5m7y16k) Cutouts: Lines at cutouts to show boundary only. Do not include cut lines in artwork. REV PN DESCRIPTIO N 100104368 DO NOT PUSH LBL 1 PIU2.2 INTENTIONAL RADIATOR LBL PART NUMBER PIU2.2 INTENTIONAL RADIATOR LBL ART 100104368 Rev. 1 2.06” (REF) 2.63” (REF) 100104368 Rev 1

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, 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 24 Test Report Curtis-Straus LLC, a wholly owned subsidiary of BV CPS Report No EN3358-1 Client Lightlab Imaging (St. Jude Medical) Jeffrey Roberts Address 4 Robbins Road Westford MA, 01886 Phone (978) 577 - 3451 Items tested C408652 Standards 47 CFR 15.225, RSS-210 Issue 8, RSS GEN Issue 3 Test Dates March 1 – 3, 24 and 31, 2014 Results As detailed within this report Prepared by Tuyen Truong – Test Engineer Authorized by Christopher Reynolds – EMC Supervisor Issue Date 5/9/14 Conditions of Issue This Test Report is issued subject to the conditions stated in the ‘Conditions of Testing’ section on page 23 of this report. Test Report for Lightlab Imaging (St. Jude Medical) Report No. EN3358-1 May 1, 2014 ______________________________________________________________________ ____________________________________________________________ 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 24 Content Content __________________________________________________________________________ 2 Regulatory Information _____________________________________________________________ 3 Summary _________________________________________________________________________ 4 Frequency Range Investigated ________________________________________________________________ 4 EUT Configuration _________________________________________________________________ 5 Compliance Statement ______________________________________________________________ 6 Test Data _________________________________________________________________________ 8 AC Mains Conducted Emissions _______________________________________________________________ 8 Test Data ______________________________________________________________________________ 8 AC Mains Setup Pictures __________________________________________________________________ 9 15.225 __________________________________________________________________________________ 10 Emissions Mask ________________________________________________________________________ 10 Test Data _____________________________________________________________________________ 12 Spurious Emissions (9 KHz – 140MHz) ______________________________________________________ 13 Emissions Setup Pictures _________________________________________________________________ 14 Frequency Stability ________________________________________________________________________ 15 Test Data _____________________________________________________________________________ 15 Occupied Bandwidth ______________________________________________________________________ 16 FCC Requirements ________________________________________________________________ 18 FCC Required labeling for Verified Devices 47 CFR Part 15.19 ______________________________________ 19 Declaration of Conformity (DoC): ____________________________________________________________ 19 FCC Required Instruction Manual Inserts ______________________________________________________ 19 Canadian Labeling /Manual Requirements _____________________________________________ 21 User Manual Notice for Licence-Exempt Radio Apparatus _________________________________________ 21 Model Number and IC _____________________________________________________________________ 21 Conditions Of Testing ___________________________________________________________ 23 Test Report for Lightlab Imaging (St. Jude Medical) Report No. EN3358-1 May 1, 2014 ______________________________________________________________________ ____________________________________________________________ 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 24 Regulatory Information FRN number 0022489843 FCC ID SB6C408652 IC 10934A-IOI1 Test Report for Lightlab Imaging (St. Jude Medical) Report No. EN3358-1 May 1, 2014 ______________________________________________________________________ Issue No. Reason for change Date Issued 1 Original Release May 1, 2014 ____________________________________________________________ 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 24 Summary This test report supports an application for certification pursuit to 47 CFR 15.225. Product tested is a radio device (RFID transceiver) which operates at 13.56MHz. The radio device is part of the C408652 unit. Testing was performed according to procedures outlined in ANCI c63.4 (2003) Emissions were maximized by rotating the device 360°, varying the test antenna height. EUT antenna could not be maximized because EUT has an on board fixed antenna. Device was also tested in 3 orthogonal axes. EUT was AC powered and EUT AC mains conducted emissions were performed using 50Ω/5μH LISN. Frequency Range Investigated 9 KHz – 30MHz AC mains conducted missions (RBW 9 KHz, VBW 30 KHz) 30 KHz – 140MHz Radiated emissions (RBW 120 KHz, VBW 1 MHz) at 3m distance. All readings are peak unless otherwise specified. Test Report for Lightlab Imaging (St. Jude Medical) Report No. EN3358-1 May 9, 2014 ______________________________________________________________________ ____________________________________________________________ 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 24 EUT Configuration EUT Configuration Work Order: N3358 Company: LightLab Imaging Company Address: 4 Robbins Road Westford MA 01886 Contact: Escipion Baez Person Present: Escipion Baez, Darin Ursuliak MN SN EUT: C408652 Sample 1 EUT Description: OPTIS TM Integrated System (internally know…

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Conducted EMI – AC Mains FCC 15.225 – Emission Mask EMI Spurious FCC 15.225 – Frequency Stability