LightLab Imaging C408652 C8i User Manual Optis Integrated IFU US E1 Draft

LightLab Imaging Inc C8i Optis Integrated IFU US E1 Draft

User Manual.pdf

OPTIS™ Integrated SystemInstructions for Use
Information provided within this Document is subject to change without notice and although believed tobe accurate, St. Jude Medical, Inc. and its affiliated companies including without limitation, St. JudeMedical 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, FR0883793, DE 69738291. ILUMIEN, OPTIS, ST. JUDE MEDICAL, LIGHTLAB IMAGING, GOLDENIMAGE and the color gold are registered or unregistered trademarks of St. Jude Medical, Inc. and itsrelated companies. The OPTIS INTEGRATED system software incorporates third party licensed software as described at thefollowing URL: www.sjmprofessional.com/ilumien-legal-noticesSt. Jude Medical Coordination Center BVBA Australian Sponsor:The Corporate Village St. Jude Medical Australia Pty LimitedDa Vincilaan 11 Box F1 17 Orion Rd.,1935 Zaventem Belgium Lane Cove NSW 2066 Australia+32 2 774 68 11 +61 2 9936 1200LightLab Imaging, Inc. Phone: +1 855 478 5833 US Toll-free4 Robbins Road +1 651 756 5833 InternationalWestford, MA 01886USAwww.sjm.comService E-mail: OCTservice@sjm.comPart Number ARTUS100109403ENGLISHPrinted in the U.S.A. 4 / 2014CAUTION: Federal law restricts this device to sale by or on the order of a Physician licensed bylaw of the state in which he practices to use or order the use of the device.
ILUMIEN OPTIS SystemInstructions for Use iiiSAFETY INFORMATIONPlease review this manual carefully before using your OPTIS Integrated System, especially the safetyinformation in Chapter 11 “Safety Information”. Also, especially note Warnings and Cautions shownthroughout the manual.WARNINGSElectrical Shock HazardDo not remove OPTIS INTEGRATED System covers. To avoid electrical shock, use only the power cordsupplied with the system and connect only to properly grounded wall outlets. See Chapter 2 “SystemSetup” and Chapter 11 “Safety Information” for electrical safety information.Explosion HazardDo not operate the OPTIS INTEGRATED System in the presence of flammable anesthetics. Doing socould lead to an explosion.Visible and Invisible Laser RadiationDo 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 UseThis manual describes the St. Jude Medical OPTIS 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.
ivConventions 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 PatientSummary 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, orother serious adverse reactions associated with product use ormisuse.CAUTION: Cautions alert the user to the possibility of a problem with theproduct associated with its use or misuse. Problems can includeproduct malfunctions, product failure, and/or damage to theproduct or damage to other property, or loss of data.NOTE: Notes provide additional information.Other Instructions for UseDetails 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 inthis manual. NOTE: Additionally, this manual does not provide detailed discussion of the sys-tem components, except as they are used with the OPTIS Integrated Sys-tem.Table Front-1: Instructions for Use ConventionsDialog Box or Menu A window that solicits a user response.Click or Left-click Click the left mouse button or the Select button on the Table Side Controller.Double-click Click the left mouse button or the Select button on the Table Side Controller twice in quick succession.Select Highlight a menu item with the mouse or the tab or arrow keys or the Navigation Controller on the Table Side Controller.
ILUMIEN OPTIS SystemInstructions for Use iContentsFiguresTablesSystem OverviewOptis Integrated System Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1OPTIS Integrated System Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2OPTIS Integrated System Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3Optis Integrated System Cabinet and Control Room Components . . . . . . . .1-4Optis Integrated System - Mobile Workstation . . . . . . . . . . . . . . . . . . . . . . .1-5OPTIS Integrated System Table Side Controller . . . . . . . . . . . . . . . . . . . . . .1-6OPTIS Integrated System DOC Holster. . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7OPTIS Integrated Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8The Drive-motor and Optical Controller (DOC). . . . . . . . . . . . . . . . . . . . . . . . . . .1-10The Wi-Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-11Indications for Use and Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-12Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-13Warnings (OCT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14Precautions (OCT). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15Complications (OCT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-16Warnings and Precautions (FFR). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17Connecting to External Equipment/Accessories . . . . . . . . . . . . . . . . . . . . . .1-17Mechanical Enclosure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17Electrical. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17Electronic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17
ContentsiiAortic Reference Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18Pressure Averaging (Mean Setting) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18Defibrillation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18System SetupPositioning the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1Connecting Your System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2System Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2Powering On and Shutting Down Your System . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2Power On System Cabinet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3Shut Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4FFR Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5Monitor Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6Setting Monitor Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6Setting Monitor Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6Opening a Patient RecordSelect Patient Menu (Home Menu) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2Patient Summary Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4Entering New Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6Editing Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8Editing Case Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9Importing a Patient Database. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10Opening a Saved Recording or Still Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11Performing an FFR ProcedureOverview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1Required Material and Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1Setting up the OPTIS Integrated System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2Setting up the Wi-Box with the OPTIS Integrated System . . . . . . . . . . . . . . . . . . .4-3Setting up the PressureWire. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
ContentsILUMIEN OPTIS SystemInstructions for Use iiiPreparing to Record FFR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5Recording FFR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11Reviewing an FFR Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13PressureWire Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15Performing an OCT ProcedureOverview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1Required Material and Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1OCT Imaging Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2OCT Operating Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3OCT Recording Types. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3OCT Trigger Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4Angio-Coregistration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-5Setting up the OPTIS Integrated System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-5Setting up the DOC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6Setting up the Dragonfly Imaging Catheter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-7Preparing to Acquire OCT Recordings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8Confirm Recording Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-12Dragonfly Imaging Catheter Insertion and Positioning. . . . . . . . . . . . . . . . . . . . . .5-13Acquiring Patient Images. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-16Removing the Dragonfly Imaging Catheter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-18Troubleshooting OCT Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-19Immediately Stopping DOC Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-19Catheter Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-20Reviewing OCT RecordingsImage Window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2L-Mode View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-4Limitations of L-Mode Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-5Playback Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6Calibration Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-7
ContentsivAdjust Playback Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-9Bookmark Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-10Setting Playback Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-11Exporting a Recording or Still Frame . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-12Capturing Still Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-12Saving a Still Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-12Printing Still Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-13Printing a Still Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-13Reviewing with Angio-Coregistration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-14Measurements and AnnotationsMeasurements and Text Callouts in the Image Files. . . . . . . . . . . . . . . . . . . . . . . .7-1Measurement and Annotation Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2Verifying Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3Techniques to Improve Measurement Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3Measurements and Annotations in the L-Mode View . . . . . . . . . . . . . . . . . .7-3Length Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-4Making a Length (Distance) Measurement . . . . . . . . . . . . . . . . . . . . . . . . . .7-5Area Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6Making a Manual Area Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6Adding Text Callouts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-8Adding Text Callouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-9The %AS Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-10Formula for %AS Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-10Make a %AS Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-10The %DS Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-12Formula for %DS Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-12Make a %DS Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-12Field of View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-14Increase/Decrease Field of View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-14Zooming In Manually. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-15Quick Zoom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-16Editing Measurements and Annotations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-17Moving Individual Points. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-18Adding Points to a Multiple Point Area. . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-18
ContentsILUMIEN OPTIS SystemInstructions for Use vDeleting Points from a Multiple Point Area. . . . . . . . . . . . . . . . . . . . . . . . . .7-18Deleting Individual Measurements or Text Callouts . . . . . . . . . . . . . . . . . . .7-19Deleting All Measurements and Text Callouts . . . . . . . . . . . . . . . . . . . . . . .7-19Lumen Profile Display Option. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-20Lumen Profile Display With MLA Controls Overview. . . . . . . . . . . . . . . . .7-213D Display Option. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-233D Tissue Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-243D Display with Lumen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-25Limitations of 3D Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-26Exporting, Importing, and Managing FilesCompatible Transfer Media and USB Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2Optical Media. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2USB Connected Media. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2File Formats. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4About Native (Raw OCT) Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4About DICOM Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4About Standard Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-5Image Format and Size in Standard Formats. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-6File Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-6Standard File Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-6Exporting Files During a Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-7Exporting Files in Native (Raw) Format . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-8Exporting Files in DICOM Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-10Exporting Files in Standard Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-12Exporting Files from the Patient Summary Menu. . . . . . . . . . . . . . . . . . . . . . . . . .8-14Using Exported Standard Format Recordings . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-16St. Jude Medical DICOM Viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-16Importing Files from a CD/DVD or USB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-20Deleting Files. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-22Deleting Files from the Patient Summary Menu . . . . . . . . . . . . . . . . . . . . . .8-22Deleting Files from the Database Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-23Transfer and Import Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-24Duplicate File Name Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-26Database Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-26Importing Patient Information From a DICOM Worklist or Storage Server.8-27
ContentsviCleaning & MaintenanceContacting St. Jude Medical Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2Routine Cleaning Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-3Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-4Optical Connection Cleaning Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5Optical Adapter Replacement Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-8Cable Connection Inspection Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-10Transferring Log Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-11Identifying the Software Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-13Infection Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-13User Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-14System Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-17User Interface ReferenceSetup Dialog Box and Submenus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1Setup - Acquisition Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2Setup - Acquisition/Other Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-4Setup - Administration Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-5Setup - Database Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-7Setup - Database/Maintenance Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-9Setup - Database/Physician Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-11Setup - DICOM Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-12Setup - DICOM/Image Options Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-17Setup - DICOM/Local Host Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-19Setup - Display Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-21Setup - Measurements Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-23Setup - Measurements/Labels Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-24Setup - Print Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-25Setup - Service Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-26Setup - Service/System Diagnostics Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-29
ContentsILUMIEN OPTIS SystemInstructions for Use viiSafety InformationPatient Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-2General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-2Techniques to Minimize Patient Exposure. . . . . . . . . . . . . . . . . . . . . . . . . .11-2Operator Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-3Avoiding Operator Light Emission Hazards . . . . . . . . . . . . . . . . . . . . . . . .11-3Repetitive Strain Injury (RSI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-3Moving the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-4Avoiding Electrical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-5Making Proper Electrical Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-6Explosion Hazard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-7System Imaging Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-7Considerations for Optimal Vessel Imaging . . . . . . . . . . . . . . . . . . . . . . . .11-7Considerations for Optimal Tissue Imaging . . . . . . . . . . . . . . . . . . . . . . . .11-7Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-8Electromagnetic Interference. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-8Safety Functions Built Into the Ilumien Optis System . . . . . . . . . . . . . . . . . . . . .11-9System SpecificationsSystem - Safety & Regulatory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-1System - Electrical and Physical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-3Imaging Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-4FFR Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-5Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-6Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-7Recommended Separation Distances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-11FCC Statement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-12Essential Performance Defined by Operating Mode . . . . . . . . . . . . . . . . . .12-12Index
Contentsviii
ILUMIEN OPTIS SystemInstructions for Use iFigures1-1 Optis Integrated System Cabinet and Control Room Components . . . . . . . .1-41-1 Optis Integrated System Mobile Workstation . . . . . . . . . . . . . . . . . . . . . . . .1-51-2 Wi-Box in cathlab configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-112-1 Startup Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-32-2 Shutdown Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-43-1 Select Patient Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23-2 Default Patient Alert. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-33-3 Patient Summary Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-43-4 Add New Patient Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-63-5 Edit Patient Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-83-6 Case Information Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-93-7 Recording as shown in the Patient Summary Menu. . . . . . . . . . . . . . . . . . . .3-113-8 OCT Review Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-124-1 Cathlab with FFR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-14-2 Room Manager: Enter Room Information . . . . . . . . . . . . . . . . . . . . . . . . . . .4-34-3 Set AO transducer height and open AO transducer guidance message . . . . .4-64-4 Flush PressureWire guidance message. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-74-5 Turn on PressureWire guidance message. . . . . . . . . . . . . . . . . . . . . . . . . . . .4-84-6 Advance PressureWire and Equalize guidance message . . . . . . . . . . . . . . . .4-94-7 Pd/Pa waveforms equalizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-114-8 Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-125-1 DOC Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-65-2 Purge Catheter guidance message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-95-3 Plug Catheter into DOC Guidance Message . . . . . . . . . . . . . . . . . . . . . . . . .5-105-4 Dragonfly Catheter Connected to the DOC . . . . . . . . . . . . . . . . . . . . . . . . . .5-105-5 Catheter Connected, Initial Calibration done. . . . . . . . . . . . . . . . . . . . . . . . .5-115-6 OCT Settings Menu (during Recording) . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-125-7 Incorrect and Correct Calibration (Dragonfly Duo shown in fingertips)5-145-8 Incorrect and Correct Calibration (Dragonfly OPTIS shown in fingertips). .5-145-9 System Display - Acquisition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-165-10 Catheter Failure message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-205-11 Safe Unload Guidance, Screen 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-215-12 Safe Unload Guidance, Screen 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-21
Figuresii5-13 Safe Unload Guidance, Screen 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-226-1 Playback Calibration (DragonFly Duo shown, in progress) . . . . . . . . . . . . .6-76-2 Field of View Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-96-3 Adjusted Playback Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-116-4 Angio-Coregistration Thumbnail Image . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-146-5 View Menu, Angio Co-Registration Button. . . . . . . . . . . . . . . . . . . . . . . . . .6-156-6 Angio Co-Registration: Register . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-166-7 Angio Co-Registration Guidance, Step 1. . . . . . . . . . . . . . . . . . . . . . . . . . . .6-166-8 Angio Co-Registration Guidance, Step 2. . . . . . . . . . . . . . . . . . . . . . . . . . . .6-176-9 Angio Co-Registration Guidance, Step 2 with Trace. . . . . . . . . . . . . . . . . . .6-186-10 Angio Co-Registration Guidance, Step 3. . . . . . . . . . . . . . . . . . . . . . . . . . . .6-196-11 Angio Co-registration completed successfully screen . . . . . . . . . . . . . . . . . .6-206-12 Main Screen showing Angio Co-Registration . . . . . . . . . . . . . . . . . . . . . . . .6-207-1 Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-27-2 Length Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-47-3 Manual Area Measurement (in progress). . . . . . . . . . . . . . . . . . . . . . . . . . . .7-67-4 Text Callouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-87-5 Enter Note Dialog Box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-97-6 Select Area Measurement Dialog Box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-107-7 %AS Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-117-8 %AS Error Message. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-117-9 Select Length Measurement Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-127-10 %DS Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-137-11 Zooming an Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-157-12 Setup Menu, Display Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-167-13 3D Display with Lumen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-257-14 MLA Frames in 3D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-258-1 Export Button (OCT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-78-2 The Export Wizard - Step 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-88-3 Define Alternate Patient ID Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-88-4 Highlighted Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-148-5 St. Jude Medical DICOM Viewer - Image View. . . . . . . . . . . . . . . . . . . . . .8-168-6 St. Jude Medical DICOM Viewer - Attributes View. . . . . . . . . . . . . . . . . . .8-178-7 Import Database Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-208-8 Deletion Warning Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-238-9 Add Patient - Step 1 (Worklist) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-278-10 Add Patient - Step 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-288-11 Add Patient - Step 1 (Storage Server) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-309-1 Inserting Cleaner Into Optical Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-69-2 Inserting Cleaner Into Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-79-3 Proper Gripping of Adapter for Removal. . . . . . . . . . . . . . . . . . . . . . . . . . . .9-89-4 Alignment of Optical Adapter with Optical Carriage . . . . . . . . . . . . . . . . . .9-99-5 Transfer Event Log Files Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-11
FiguresILUMIEN OPTIS SystemInstructions for Use iii9-6 System Startup Window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1310-1 Setup - Acquisition Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-210-2 Setup - Acquisition/Other Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-410-3 Setup - Administration Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-510-4 Setup - Database Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-710-5 Setup - Database/Maintenance Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-910-6 Setup - Database/Physician Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1110-7 Setup - DICOM Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1310-8 Configure DICOM Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1410-9 Setup - DICOM/Image Options Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1710-10 Setup - DICOM/Local Host Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1910-11 Setup - Display Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2110-12 Setup - Measurements Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2310-13 Setup - Measurements/Labels Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2410-14 Setup - Print Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2510-15 Setup - Service Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2610-16 Setup - Service/System Diagnostics Menu . . . . . . . . . . . . . . . . . . . . . . . . .10-2911-1 Connector Panel Laser Safety Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-311-2 Electrical Label. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-6
Figuresiv
ILUMIEN OPTIS SystemInstructions for Use iTablesFront-1 Instructions for Use Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Front-iv1-1 Symbols Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-81-2 DOC Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-103-1 Select Patient Menu functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23-2 Patient Summary Menu functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-44-1 FFR Review Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-135-1 System Display Description - Acquisition. . . . . . . . . . . . . . . . . . . . . . . . . . .5-166-1 OCT Display Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-26-2 L-Mode view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-46-3 Playback Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-66-4 Bookmark Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-107-1 Measurement and Annotation Tool Functions. . . . . . . . . . . . . . . . . . . . . . . .7-27-2 MLA Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-217-3 Lumen Profile %AS and %DS Calculations . . . . . . . . . . . . . . . . . . . . . . . . .7-227-4 3D Tissue Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-248-1 Optical Media Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-28-2 DICOM File Attributes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-188-3 Import Database Menu Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-218-4 Transfer Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-248-5 Duplicate File Name Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-269-1 User Troubleshooting Tips. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1410-1 Setup Dialog Box Common Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-110-2 Setup - Acquisition Menu Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-210-3 Setup - Acquisition/Other Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . .10-410-4 Setup - Administration Menu Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-510-5 Setup - Database Menu Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-710-6 Setup - Database/Maintenance Menu Settings. . . . . . . . . . . . . . . . . . . . . . .10-910-7 Setup - Database/Physician Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1110-8 Setup - DICOM Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1310-9 Setup - Configure DICOM Menu Settings. . . . . . . . . . . . . . . . . . . . . . . . . .10-15
Tablesii10-10 Setup - DICOM/Image Options Menu Settings . . . . . . . . . . . . . . . . . . . . . .10-1710-11 Setup - DICOM/Local Host Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . .10-1910-12 Setup - Display Menu Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2110-13 Setup - Measurements Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2310-14 Setup - Measurements/Labels Menu Settings . . . . . . . . . . . . . . . . . . . . . . .10-2410-15 Setup - Print Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2510-16 Setup - Service Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2710-17 Setup - Service/System Diagnostics Menu Settings. . . . . . . . . . . . . . . . . . .10-2912-1 System Safety & Regulatory Specifications . . . . . . . . . . . . . . . . . . . . . . . .12-112-2 System Electrical and Physical Specifications. . . . . . . . . . . . . . . . . . . . . . .12-312-3 Imaging Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-412-4 FFR Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-512-5 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions . .12-612-6 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity . .12-712-7 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity . .12-912-8 Recommended separation distances between portable and mobile RF communica-tions equipment and the Ilumien Optis System12-11
ILUMIEN OPTIS SystemInstructions for Use 1-1System Overview 1OPTIS Integrated System FeaturesOptical Coherence Tomography (OCT) is an imaging modality that uses fiber-optic tech-nology. The OPTIS INTEGRATED System uses optical imaging catheters that emitnear-infrared light to produce high-resolution real-time images. The frequency and band-width characteristics of the near-infrared light used in these systems result in image reso-lution that is superior to typical medical ultrasound images.Fractional Flow Reserve (FFR) is the ratio of distal coronary arterial pressure to aorticpressure, measured during hyperemia. It provides the maximal blood flow in the presenceof a stenosis as a fraction of the achievable blood flow that would exist in the hypotheticalsituation that the stenosis was not present. The physician may use the FFR parameter,along with knowledge of patient history, medical expertise and clinical judgment to deter-mine if therapeutic intervention is indicated. This functionality is achieved when theOPTIS INTEGRATED System is used in conjunction with the manufacturer's wireless distalintracoronary pressure transducer and a proximal aortic pressure transducer.The OPTIS Integrated System is built into the catheter lab so that OCT and FFR areimmediately available without the need to find, connect, position, and power-on a mobileconsole. The system allows either the sterile operator or non sterile operator to controlsystem functions during image and FFR acquisition and review, and to view the OCT andFFR images on the main catheter lab monitor boom or on the Mobile Workstation moni-tor. In addition, the system incorporates angio co-registration, which allows the user tovisualize the position of OCT image data on angiography images, tightening the linkagebetween anatomical assessment with OCT and subsequent therapeutic actions. CAUTION: Medical personnel who use the OPTIS INTEGRATED System must beaware of the system’s limitations. Only trained operators can deter-mine if use of the OPTIS INTEGRATED System is appropriate. Be sureto read Chapter 11 “Safety Information”, before operating the OPTISINTEGRATED System for the first time.
System OverviewOPTIS Integrated System ComponentsSt. Jude Medical1-2 Part Number ARTUS100109403OPTIS INTEGRATED System ComponentsThe OPTIS INTEGRATED System includes the following components, integrated into acatheter lab:• A system Cabinet which includes an isolation transformer, a laser imaging engine,and a computer.• A keyboard, and a mouse.1• A Drive-motor and Optical Controller (DOC).• A Table Side DOC Holster• A Table Side Controller• Aortic pressure and PressureWire receivers.• A Mobile Workstation which includes a monitor, keyboard, and mouse.NOTE: Use only the power cable and accessories provided with the system. Use ofother cables or accessories may negatively affect EMC performance.NOTE: FFR procedures require you to have a Wi-Box installed in your cathlab.See your St. Jude Medical service representative for more information.CAUTION: The above components are integral parts of the OPTIS INTEGRATED Sys-tem. The hardware and software must not be modified in any way by thecustomer. Making such modifications may interfere with correct operationand will void system warranties. See your St. Jude Medical service represen-tative for more information.NOTE: Contact your St. Jude Medical service representative whenever there isnew construction in catheter lab.See Chapter 12 “System Specifications” for more information on system components.1. Brands and models of components may vary from those shown in this manual.
System OverviewOPTIS Integrated System ComponentsILUMIEN OPTIS SystemInstructions for Use 1-3OPTIS INTEGRATED System Accessories• PressureWire•Wi-Box• C7 Dragonfly™ imaging catheter, Dragonfly™ Duo imaging catheter, or Dragon-fly™ OPTIS™ imaging catheter.• Sterile DOC Cover• 3 ml SyringeNOTE: See your sales representative for order numbers of accessories in yourmarket.
System OverviewOPTIS Integrated System ComponentsSt. Jude Medical1-4 Part Number ARTUS100109403OPTIS Integrated System Cabinet and Control Room ComponentsFigure 1-1: OPTIS Integrated System Cabinet and Control Room ComponentsControl Room MonitorON/OFF CD/DVD TrayCD Eject Power Switch/ IndicatorButtonKeyboard Mouse
System OverviewOPTIS Integrated System ComponentsILUMIEN OPTIS SystemInstructions for Use 1-5OPTIS INTEGRATED System - Mobile WorkstationLocking KeyboardMonitorMouseCasters (4) ON/OFFFigure 1-1: OPTIS Integrated System Mobile Workstation
System OverviewOPTIS Integrated System ComponentsSt. Jude Medical1-6 Part Number ARTUS100109403OPTIS Integrated System Table Side ControllerTable Side Controller: The TSC may be used to position the mouse cursor by moving theNavigation Controller to left, right, up, or down. The Select button (on the top of theNavigation Controller) functions as the left mouse button, and a twist of the NavigationController functions as the mouse scroll wheel (twist left is scroll up and twist right isscroll down).Wireless Connectivity Indicator: Blue = Connected Yellow = No ConnectionNavigation Rail ClampZoomFeaturesMeasurementAuto LumenProfileDistal Marker Proximal MarkerTable Side ControllerSelect ButtonControllerWireless ConnectivityIndicator
System OverviewOPTIS Integrated System ComponentsILUMIEN OPTIS SystemInstructions for Use 1-7OPTIS Integrated System DOC HolsterDOC HolsterDust CoverRail ClampCable Connections
System OverviewOPTIS Integrated System ComponentsSt. Jude Medical1-8 Part Number ARTUS100109403OPTIS INTEGRATED SymbolsBefore using the system, read these Instructions for Use carefully, including the identifi-cation of symbols used on the equipment.Table 1-1: Symbols DescriptionEquipotential Grounding Post - For a secondary ground connection between equipment.European Conformance, BSI Notified Body (British Standards Institution)Indoor use only. No protection against ingress of water.Curtis Straus NRTLLaser hazard symbol - marks a device which produces visible and invisible laser radiation.VIDEO: For connection to an external boom monitor.ATTENTION!: consult accompanying documents.NETWORK: For connecting to a Remote DICOM Server through a network (see the DICOM Setup menus in Chapter 10 “User Interface Reference”).USB: For connection of external storage devices (see “USB Connected Media” on page 8-2).WARNING:If the USB device is being used in the patient vicinity it mustbe port powered or it may compromise electrical isolationand cause patient injury.Type CF, defibrillator-proof. Suitable for all patient applications including direct cardiac applications.Do not push the system from the monitors or monitor support mount. See “Moving the System” on page 11-4 for all safety instructions on moving the system.
System OverviewOPTIS Integrated System ComponentsILUMIEN OPTIS SystemInstructions for Use 1-9WARNING: All connections to the OPTIS INTEGRATED System must be madethrough the System Connector Panel. Making connections directly tointernal components of the system may bypass isolation features andcompromise patient safety.Date of ManufactureFCC Identification NumberIndustry Canada certificationAustralian Communications and Media Authority supplier code numberConsult instructions for useInterference may occur in the vicinity of this equipmentDisposal of the equipment must be in accordance with local laws.Temperature Range (Shipping label)Atmospheric Range (Shipping label)Humidity Range (Shipping label)Table 1-1: Symbols Description (continued)500hPa1060hPa
System OverviewThe Drive-motor and Optical Controller (DOC)St. Jude Medical1-10 Part Number ARTUS100109403The Drive-motor and Optical Controller (DOC)The Drive-motor and Optical Controller (DOC) provides bed-side control of the mostimportant OCT imaging functions. Refer to “Preparing to Acquire OCT Recordings” onpage 5-8 for Dragonfly Imaging Catheter connection details.Table 1-2: DOC ControlsLock LED • Off when the imaging catheter is not loaded.•Blinking when loading or unloading the imaging catheter.•On when the imaging catheter is loaded.Unload Press to unload the imaging catheter.Live View Press to switch between Standby View and Live View.When the button is lit in green, the system is in Live View.When the button is blinking, the system is enabled to begin a pullback recording.NOTE: If the Recording Type is set to Stationary, this button does not blink.Enable Press to Auto Calibrate or to Enable recording (if calibration is complete).Stop Press to stop imaging catheter motion and turn off laser output.Pullback Motion LEDs •Off when the imaging catheter is stationary.•Blinks during pullback.Laser Emis-sion Symbol Illuminated when laser output is on (whenever the system is in Live scanning mode).Live View buttonLock LEDUnload buttonPullback Motion LEDsStop buttonEnable buttonLaser Emission Symbol
System OverviewThe Wi-BoxILUMIEN OPTIS SystemInstructions for Use 1-11The Wi-BoxThe Wi-Box is installed in your cathlab between your Hemodynamic Recording Systemand the AO Transducer. The position of the Wi-Box in a cathlab is shown in Figure 1-2.The wireless connection to your Wi-Box is made during setup for your procedure. See“Setting up the Wi-Box with the OPTIS Integrated System” on page 4-3 for more infor-mation.Figure 1-2: Wi-Box in cathlab configuration
System OverviewIndications for Use and Intended UseSt. Jude Medical1-12 Part Number ARTUS100109403Indications for Use and Intended UseThe OPTIS INTEGRATED Imaging System with Dragonfly Imaging Catheter is intendedfor the imaging of coronary arteries and is indicated in patients who are candidates fortransluminal interventional procedures. The Dragonfly Imaging Catheter is intended foruse in vessels 2.0 to 3.5 mm in diameter. The Dragonfly Imaging Catheter is not intendedfor use in the left main coronary artery or in a target vessel which has undergone aprevious bypass procedure.The OPTIS INTEGRATED Imaging System will further acquire radio frequency signaloutputs from both a distal intracoronary pressure transducer and a proximal aorticpressure transducer to determine the physiological parameter, Fractional Flow Reserve(FFR). The physician may use the FFR parameter, along with knowledge of patienthistory, medical expertise and clinical judgment to determine if therapeutic interventionis indicated.CAUTION: The OPTIS INTEGRATED System is intended for use by appropriatemedical personnel who have received OPTIS INTEGRATED training.St. Jude Medical and its employees cannot give instructions in theinterpretation or diagnosis of recordings and makes no attempt to doso.WARNING: Prior to use, please review the Instructions for Use supplied with theDragonfly Imaging Catheter and with the PressureWire for moreinformation.
System OverviewContraindicationsILUMIEN OPTIS SystemInstructions for Use 1-13ContraindicationsUse of the St. Jude Medical OPTIS INTEGRATED System is contraindicated where intro-duction of any catheter would constitute a threat to patient safety.Contraindications (listed alphabetically) include:• Bacteremia or sepsis• Major coagulation system abnormalities• Patients diagnosed with coronary artery spasm• Patients disqualified for CABG surgery• Patients disqualified for PTCA• Severe hemodynamic instability or shock• Total occlusion• Large thrombus• Acute renal failureNOTE: The system has no patient alarm functions. Do not use for cardiac monitor-ing.
System OverviewWarnings (OCT)St. Jude Medical1-14 Part Number ARTUS100109403Warnings (OCT)• Appropriate anticoagulant and vasodilator therapy must be used during the proce-dure as needed.• Observe all advancement and movement of the Dragonfly Imaging Catheter underfluoroscopy. Always advance and withdraw the catheter slowly. Failure to observedevice movement fluoroscopically may result in vessel injury or device damage.• Leave the guidewire engaged with the catheter at all times during use. Do not with-draw or advance the guidewire prior to withdrawing the catheter.• If resistance is encountered during advancement or withdrawal of the DragonflyImaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause ofresistance cannot be determined or mitigated, carefully remove the catheter andguidewire together.• The catheter should never be forced into lumens that are narrower than the catheterbody or forced through a tight or heavily calcified lesion.• The catheter should not be advanced through abnormally tortuous anatomy.• When advancing or retracting a catheter with a minirail tip through a stented vessel,the catheter may engage the stent between the junction of the catheter and guide-wire, resulting in entrapment of catheter/guidewire, catheter tip separation, and/orstent dislocation.• Refer to the contrast media’s instructions-for-use for general warnings and precau-tions relating to use of the contrast media.CAUTION: Before creating an OCT recording, review Chapter 5 “Performing anOCT Procedure” for additional warnings and cautions.
System OverviewPrecautions (OCT)ILUMIEN OPTIS SystemInstructions for Use 1-15Precautions (OCT)• Safety and effectiveness have been established for the following patient population:adult patients undergoing non-emergent percutaneous coronary interventions inlesions with reference vessel diameters between 2.0 to 3.5 mm, which were notlocated in the left main coronary artery or in a target vessel which has undergoneprevious bypass procedures.• All operators must be trained prior to using the OPTIS INTEGRATED System and theDragonfly Imaging Catheter.• Only 100% contrast media is approved for human use.• Store the catheter at ambient temperature in a dry location out of direct sunlight.• Never attempt to attach or detach a catheter to the DOC while the “lock” LED is lit.• Do not kink, sharply bend, pinch, or crush the catheter at any time.• The catheter is for single use only. Do not reuse, re-sterilize, or reprocess.• The catheter is sterilized by ethylene oxide and is intended for one time use only.Non-pyrogenic. Do not use if the package is opened or damaged.• After use, the catheter may be a potential biohazard. Handle and dispose of inaccordance with accepted medical practice and applicable laws and regulations.• The catheter has no user serviceable parts. Do not attempt to repair or alter any partof the catheter assembly as provided.
System OverviewComplications (OCT)St. Jude Medical1-16 Part Number ARTUS100109403Complications (OCT)The risks involved in vascular imaging include those associated with all catheterizationprocedures. The following complications (listed alphabetically) may occur as a conse-quence of intravascular imaging and may necessitate additional medical treatment includ-ing surgical intervention.• Acute myocardial infarction or unstable angina• Allergic reaction to the contrast media• Arterial dissection, injury, or perforation• Cardiac arrhythmias• Coronary artery spasm• Death• Embolism• Thrombus formation
System OverviewWarnings and Precautions (FFR)ILUMIEN OPTIS SystemInstructions for Use 1-17Warnings and Precautions (FFR)CAUTION: Before beginning an FFR procedure, review the PressureWire Instruc-tions for Use. Details of the PressureWire are covered in the Pres-sureWire Instructions for Use and are not covered in this manual. CAUTION: Patients with potential microvascular dysfunction and borderlineFFR values should be interpreted with caution, and managementstrategies should be guided not only by pressure measurement, butalso by possibly supplementary clinical risk stratification and othertests.Connecting to External Equipment/AccessoriesWARNING: When used in the patient environment, all equipment connected to the OPTIS INTEGRATED System must meet the requirements for medical isolation according to the IEC 60601 safety standards. Connection of equipment that does not follow relevant IEC standards (e.g. IEC 60601 series for medical electrical equipment) may lead to patient injury or death.CAUTION: No connections to other systems or components are to be made to the OPTIS INTEGRATED System except through the Connector Panel. No connections are to be made through the Connector Panel except as described in this manual.In addition, all such combinations of systems shall comply with the standard IEC 60601-1-1, Safety requirements for medical electrical systems. Any person who connects external equipment to the OPTIS INTEGRATED system has formed a medical system and is therefore responsible for compliance of the system with the requirements of IEC 60601-1-1. If in doubt contact a qualified technician. Only PressureWire and Wi-Box are intended to be used with the OPTIS INTEGRATED System wireless receivers.Mechanical EnclosureWARNING: Do not use the OPTIS INTEGRATED System if it has been dropped or in another way exposed to mechanical or electrical damage or if liquids have penetrated the housing, or the user or patient may be exposed to electrical shock or faulty readings may appear. Contact your supplier for further action.CAUTION: Ensure that all ventilation holes are unblocked or else system overheating and false readings may occur.ElectricalWARNING: The mains power remains switched on when the system is in STANDBY mode.Avoid direct or indirect (e.g. via the operator) conductive connection between other electrical equipment and the OPTIS INTEGRATED System. Conductive connection may cause leakage currents to induce ventric-ular fibrillation. High frequency surgical equipment must not be used on a patient at the same time as Pres-sureWire and the OPTIS INTEGRATED System.Electronic InterferenceCAUTION: Radio transmitting equipment, cellular phones and strong emission sources such as high fre-quency surgical equipment shall not be used in the close proximity of the OPTIS INTEGRATED System since this could influence the performance of the device.
System OverviewWarnings and Precautions (FFR)St. Jude Medical1-18 Part Number ARTUS100109403Aortic Reference PressureCAUTION: Check that the monitor cables and AO adapter delivered with the OPTIS INTEGRATED System interface are compatible with the cathlab system to be used. The Aortic Pressure Transducer (AO) should be in accordance with ANSI/AAMI BP22-1994.Once the lab monitor system has been zeroed, use only the OPTIS INTEGRATED System to calibrate the aor-tic pressure transducer and PressureWire.Pressure Averaging (Mean Setting)CAUTION: Choice of excessively high number of heartbeats may result in insensitive pressure averaging (noticeable when there is a short hyperemic plateau). Choice of excessively low number of heartbeats may result in pressure averaging, which are overly sensitive to arrhythmia and pressure disturbances. An insen-sitive or overly sensitive mean average of pressure may result in an incorrect FFR value.DefibrillationCAUTION: The OPTIS INTEGRATED System is a CF Class I equipment and protected against the effects of a discharge of a defibrillator. PressureWire readings may be affected by defibrillation. Recalibrate Pres-sureWire after defibrillation use.RecordingCAUTION: The system may place the point of FFR at the wrong location due to abnormal heart beat or artefact in Pa from flushing the guiding catheter. The responsible physician should confirm that the point selected by the system is a valid point of FFR.CAUTION: If the cursor position has been saved, the FFR value is changed accordingly.CAUTION: Before creating an FFR recording, review Chapter 4 “Performing anFFR Procedure” for additional warnings and cautions.CAUTION: After use, the catheter may be a potential biohazard. Handle and dis-pose of in accordance with accepted medical practice and applicablelaws and regulations.
ILUMIEN OPTIS SystemInstructions for Use 2-1System Setup 2Positioning the SystemWARNING: Failure to position the system components as described may lead to asystem tipping hazard or a pinching hazard, causing possible patientor operator injury and damage to the system.• Confirm that the OPTIS Integrated System Cabinet is on a level surface inside theControl Room or X-Ray Room. Confirm that the Control Room Monitor, keyboard,and mouse are located on the Control Room Table. NOTE: The USB ports are located on the keyboard.• Mount the Table Side Controller onto the operating table rail in a location that iscomfortable for the physician during the procedure.• Position the optional OPTIS Integrated Mobile Workstation (if used) at the foot ofthe patient table with the monitor facing the attending physician.Care must be taken to ensure the Mobile Workstation is clear of any moving equip-ment, including the angiography system. It is the responsibility of the attendingphysician to ensure that collisions do not occur.NOTE: Whenever the Mobile Workstation is used near moving equipment,it is recommended that the wheels remain unlocked to allow the sys-tem to roll if it is bumped.• Ensure the power cord and any other connections to the Mobile Workstation arerouted to prevent a tripping hazard. Ensure that the main power switch and powerplug can be accessed at any time during the procedure.
System SetupConnecting Your SystemSt. Jude Medical2-2 Part Number ARTUS100109403Connecting Your SystemSystem ConnectionsTo connect the Mobile Workstation to power, plug the power cord into a grounded elec-trical outlet. There is no Main Power Switch on the Mobile Workstation. The SystemCabinet and Monitors are normally always connected to power.Powering On and Shutting Down Your SystemMake sure the power cords are connected to the System Cabinet, optional Mobile Work-station (if used), and control room monitor and they are plugged into grounded electricaloutlets. For detailed information on electrical requirements, see “Making Proper Electri-cal Connections” on page 11-6.WARNING: Never use a converter adapter to plug the three-pronged AC plug intoa two-pronged, ungrounded wall outlet. Doing so may result in electricshock to the patient or operator and damage to equipment.
System SetupPowering On and Shutting Down Your SystemILUMIEN OPTIS SystemInstructions for Use 2-3Power On System CabinetTo power on your System Cabinet:1. Confirm that all monitors are powered by observing that the appropriate powerindicators are lit. See “Monitor Setup” on page 2-6 for details.2. Press the main power switch located at the upper-right side of the front of the cabi-net to turn on system power (see Figure 1-1 on page 1-4).The system's Startup screen appears (Figure 2-1).NOTE: The first time the software runs, the End User Licence Agreement (EULA)displays. You must first read and agree to the EULA by checking the “Iagree to the terms of the EULA” checkbox in order to proceed. NOTE: Once the system is turned on and the System Display is being shown, youmay need to adjust the monitor’s brightness and contrast as described in“Monitor Setup” on page 2-6.Figure 2-1: Startup Screen
System SetupPowering On and Shutting Down Your SystemSt. Jude Medical2-4 Part Number ARTUS100109403Shut DownCAUTION: Do not unplug from AC power or turn off main power until the shut-down is complete, the screens turn black, and the monitor LEDs turnamber. Disconnecting from AC power before the shutdown is com-plete may damage the system.NOTE: Use the Shutdown button at the top of the screen to shut down the system.Use of the ON/OFF switch is not recommended to shut down the system.To shut down the system:1. Click the Shutdown button located at the top of the screen. The system's Shutdownmenu appears (Figure 2-2).2. Click Yes to begin the system shutdown, or No to continue using the system.If you choose Yes, the computer begins the system shutdown. After 15 seconds, thescreens turn black, the monitor LEDs turn amber, and the system enters standbymode.3. After the screens turn black and the monitor LEDs turn amber, press the mainpower switch at the base of the cart to turn off system power.4. If necessary, disconnect the power cord from AC power.Figure 2-2: Shutdown Menu
System SetupFFR SettingsILUMIEN OPTIS SystemInstructions for Use 2-5FFR SettingsNOTE: To access the full FFR Settings menu, you must be in the process of mak-ing an FFR recording, and have selected a room for the FFR procedure.1. Click the Settings button at the top of the screen.The FFR Settings menu opens.2. Confirm that the FFR settings are correct for this patient.•Pressure Scale: Changes the vertical scale of the pressure waveform display.The default setting is 0-200 mmHg.•Sweep Speed: Changes how fast the screen is updated and the level of detailvisible to the user. A high number is suitable when a detailed picture of thetracings is required. A low number is suitable when displaying slow changes,for instance during intravenous infusing and pullback. The default setting isNormal.•Mean Filter Length (Beats): Changes the time over which the mean pres-sure value is calculated. The adjustments are made by selecting the mean cal-culation filter length, measured in number of heartbeats. The default setting is3 heartbeats.CAUTION: Choosing a high number of heartbeats makes the pressureaveraging slower and less sensitive to artifacts, but mayalso result in overly insensitive averaging which is notice-able when there is a short hyperemic plateau. Choosing alow number of heartbeats makes the pressure averagingfaster and more sensitive to pressure changes, desirableusing a short hyperemic plateau, but it may also result inan averaging overly sensitive to arrhythmia and pressuredisturbances.NOTE: An insensitive or overly sensitive averaging of pressure mayresult in an incorrect FFR value.Changes in the Mean Filter Length setting are not applied toprevious FFR recordings. When a new patient is selected, the Mean Filter Length set-ting is reset to 3 heartbeats.
System SetupMonitor SetupSt. Jude Medical2-6 Part Number ARTUS100109403Monitor SetupThe flat panel display monitors provided with the System have controls for brightness,contrast, and other monitor functions. Each monitor’s display angle is adjustable.Setting Monitor FunctionsRefer to the Instructions for Use that accompanied your monitor.Setting Monitor PositionThe angle of the flat panel monitor should be set to eliminate or minimize glare from sur-rounding lighting. To optimize viewing:1. Grasp the monitor firmly with one hand on each side of the screen.2. Adjust the viewing angle by tilting the monitor.
ILUMIEN OPTIS SystemInstructions for Use 3-1Opening a Patient Record 3CAUTION: Please note St. Jude Medical makes no representation or warrantythat use of the OPTIS INTEGRATED System complies with applicableprivacy, security and confidentiality laws, but encourages you toassess your own risk as you use, disclose, control, process or transferpatient health information with the OPTIS INTEGRATED System.
Opening a Patient RecordSelect Patient Menu (Home Menu)St. Jude Medical3-2 Part Number ARTUS100109403Select Patient Menu (Home Menu)When the system is first started, the Select Patient menu is displayed (Figure 3-1). Fromthis menu, you can enter a new patient in the database, open an existing patient, or importa previous patient record.Table 3-1: Select Patient Menu functionsASearch button: Enter a term and click this button to search the patient database.BCase Filter drop-down list box: Select ALL cases, OCT only, or FFR only. CImport button: Click this button to open the Import menu.DExport button: Click this button to open the Export Wizard.EAdd New Patient button: Click this button to enter a new patient into the System data-base.FList of all existing patients in the system database. Click on a column header to sort the patients according to data in that column. Scroll names with mouse wheel (or twist Navagation Controller) as desired; single-click name to select patient.GMenu: Displays the context-sensitive menu.Figure 3-1: Select Patient MenuADBFCEG
Opening a Patient RecordSelect Patient Menu (Home Menu)ILUMIEN OPTIS SystemInstructions for Use 3-3WARNING: If you select the default patient (“Patient, Default” in the patient list),the system displays an alert (Figure 3-2). Do not use the default patientto store patient images. Click OK to continue to use the defaultpatient, or Cancel to return to the Select Patient menu to selectanother patient.Figure 3-2: Default Patient Alert
Opening a Patient RecordPatient Summary MenuSt. Jude Medical3-4 Part Number ARTUS100109403Patient Summary MenuWhen you click on a patient name, the Patient Summary menu for that patient opens(see Figure 3-3). If there are previous recordings for this patient, they are shown here,sorted by date, with the most recent recordings at the top.Table 3-2: Patient Summary Menu functionsAPatient information, including name, ID, date of birth, and gender.BEdit Case : Click this button to edit case information. CShutdown : Click this button to begin the shutdown sequence for the system.DExport : Click the Checkbox in one or more recordings to select them, then click the Export button to open the Export Wizard.EEdit Patient : Click this button to edit patient information.FNew FFR Recording : Use this button to begin a new FFR recording for this patient.GHome : Use this button to return to the Select Patient menu.HMenu: Displays the context-sensitive menu. Provides access to the Setup menu.IDelete : Check one or more recordings to select them, and click the Delete button to delete them.JNew OCT Recording : Use this button to begin a new OCT recording for this patient.KGallery of existing recordings for this patient on the date highlighted at left. Double-click in the Comment field to add a comment for that recording. Click the Review button under a recording to open it.Figure 3-3: Patient Summary MenuACDIHEFGJLKB
Opening a Patient RecordPatient Summary MenuILUMIEN OPTIS SystemInstructions for Use 3-5LCase List (dates of recordings) for this patient. The list is sorted by date, with the most recent recordings at the top.Table 3-2: Patient Summary Menu functions
Opening a Patient RecordEntering New Patient InformationSt. Jude Medical3-6 Part Number ARTUS100109403Entering New Patient InformationYou can enter a new patient from the Select Patient menu.1. In the Select Patient menu, select the Add Patient button. Click Next.The Add Patient Wizard displays. NOTE: You can also import patient information from a DICOM storageserver or worklist. See “Importing Patient Information From aDICOM Worklist or Storage Server” on page 8-27.2. Select Add Patient, then click Next.The Add new patient menu opens (see Figure 3-4).Figure 3-4: Add New Patient Menu
Opening a Patient RecordEntering New Patient InformationILUMIEN OPTIS SystemInstructions for Use 3-73. Enter the patient information as needed.NOTE: You must enter Patient ID, First name, and Last name before youcan save the patient information.4. Click New OCT Recording to save and begin a new OCT recording for thispatient, click New FFR Recording to save and begin a new FFR recording for thispatient, or Cancel to close the menu without saving and return to the Select Patientmenu. Click Back to return to the Add Patient Wizard.
Opening a Patient RecordEditing Patient InformationSt. Jude Medical3-8 Part Number ARTUS100109403Editing Patient InformationThe patient information can be edited from the Patient Summary menu.1. In the Select Patient menu, click on the patient.The Patient Summary menu for that patient opens (see Figure 3-3).2. Click the Edit Patient button.The Edit Patient menu opens (see Figure 3-5).3. Edit the patient information as needed.NOTE: You must enter Patient ID, First name, and Last name before youcan save the patient information.4. Click OK to save the changes, or Cancel to close the menu without saving.Figure 3-5: Edit Patient Menu
Opening a Patient RecordEditing Case InformationILUMIEN OPTIS SystemInstructions for Use 3-9Editing Case InformationThe physician name and accession number for a case can be edited from the PatientSummary menu.1. In the Select Patient menu, click on the patient.The Patient Summary menu for that patient opens (see Figure 3-3).2. Click on a case to select it. NOTE: In the OPTIS INTEGRATED System, all recordings and still imagesfrom the same date use the same physician and accession number.3. Click the Edit Case button.The Case Information menu opens (see Figure 3-6).4. Edit the Physician name and Accession Number as needed.5. Click OK to save the changes, or Cancel to close the menu without saving.Figure 3-6: Case Information Menu
Opening a Patient RecordImporting a Patient DatabaseSt. Jude Medical3-10 Part Number ARTUS100109403Importing a Patient DatabasePrevious C7 XR, ILUMIEN, and OPTIS INTEGRATED OCT and FFR recordings can beimported into the system using the Import button on the Select Patient menu. For moreinformation on importing patient files or information, see “Importing Files from aCD/DVD or USB” on page 8-20.
Opening a Patient RecordOpening a Saved Recording or Still ImageILUMIEN OPTIS SystemInstructions for Use 3-11Opening a Saved Recording or Still ImageEach recording or still image has an entry in the Patient Summary menu. The entryincludes a timestamp and a thumbnail, and can display the Vessel, Procedure, and aComment, if added. The thumbnail adds icons to represent the status and content of thefile:• A “camera” icon indicates a still frame from an OCT recording.• A “safe” icon indicates that the file has been archived.To review a saved recording or still image:1. Open the Patient Summary menu:•From the Select Patient menu, click on a patient’s name to select.• From an OCT or FFR recording, click on the End Review button at the bot-tom of the screen.The Patient Summary menu for that patient opens (Figure 3-3 on page 3-4).2. Click the date of the recording from the dates at the left of the menu.All recordings and still images for that patient on that date are displayed.3. Click on the Review button beneath the recording you want to open.The recording or still image opens. Recordings play automatically.Figure 3-7: Recording as shown in the Patient Summary Menu
Opening a Patient RecordOpening a Saved Recording or Still ImageSt. Jude Medical3-12 Part Number ARTUS100109403• To navigate an OCT recording, see “Playback Controls” on page 6-6; to nav-igate an FFR recording, see “Reviewing an FFR Recording” on page 4-13.• To add measurements and annotations to the OCT recording or still frame, seeChapter 7 “Measurements and Annotations”.• To export the entire OCT recording or individual frames, see Chapter 8“Exporting, Importing, and Managing Files”.4. To end the review and return to the Patient Summary menu, click the End Reviewbutton.Figure 3-8: OCT Review Screen
ILUMIEN OPTIS SystemInstructions for Use 4-1Performing an FFR Procedure 4OverviewThe FFR procedure requires up to two operators; a sterile operator and optionally, anon-sterile operator. All steps requiring contact with the PressureWire must be performedby the sterile operator. Any steps performed in direct contact with a keyboard or mousemust be performed by the non-sterile operator.A typical cathlab configured for FFR is shown below.Required Material and Equipment•OPTIS INTEGRATED System• PressureWire• Wi-Box, installed in each room where the OPTIS INTEGRATED System is to be usedto measure FFR• Heparinized, physiologic saline solution, for hydrophilic catheter preparationFigure 4-1: Cathlab with FFR
Performing an FFR ProcedureSetting up the OPTIS Integrated SystemSt. Jude Medical4-2 Part Number ARTUS100109403Setting up the OPTIS INTEGRATED System1. Position the system for use. See “Positioning the System” on page 2-1.2. Turn on the system. See “Power On System Cabinet” on page 2-3.
Performing an FFR ProcedureSetting up the Wi-Box with the OPTIS Integrated SystemILUMIEN OPTIS SystemInstructions for Use 4-3Setting up the Wi-Box with the OPTIS INTEGRATED SystemThe Wi-Box should be connected to your facility’s Hemodynamic Recording System atinstallation. Complete the following steps to connect the OPTIS INTEGRATED System toa Wi-Box for the first time .1. Verify that the Wi-Box is powered-up by checking the power indicator light. Referto the installation instructions that came with your Wi-Box for further information.2. From the Patient Summary screen or from the Select Patient menu, click on theMenu button.3. Click the Setup menu option.4. Click on Room Manager. The Room Manager displays.5. Verify that the Wi-Box Serial Number that appears in this dialog box matches theSerial Number of the Wi-Box in your catheter lab. Figure 4-2: Room Manager: Enter Room Information
Performing an FFR ProcedureSetting up the PressureWireSt. Jude Medical4-4 Part Number ARTUS100109403NOTE: Be sure to check the Wi-Box serial number. The Devices box willauto-detect any active Wi-Box that is in-range. Ensure that theWi-Box serial number selected matches the Wi-Box device presentin the current room. (The serial number is visible on the front panelof the Wi-Box.)NOTE: The Wi-Box serial numbers can also be entered directly into theDevices box.NOTE: To change the Wi-Box selection, select the Wi-Box Serial Number inthe Room Manager dialog box, which enables the Remove button.Then, click the Remove button to delete the current selection. Then,follow the steps listed in “Setting up the Wi-Box with the OPTISIntegrated System” on page 4-3 above.Setting up the PressureWireWARNING: Please review the Instructions for Use supplied with the PressureWirefor a complete list of warnings, cautions, and setup instructions.
Performing an FFR ProcedurePreparing to Record FFRILUMIEN OPTIS SystemInstructions for Use 4-5Preparing to Record FFRWARNING: The heart rate and mean pressure values shown on the OPTIS INTE-GRATED System are for reference only and are not intended to be usedas the primary display.Start FFR recordings from the Patient Summary menu.1. If necessary, enter the patient’s information. See “Entering New Patient Informa-tion” on page 3-6.NOTE: Patient information should be entered into the system and selectedfor use before beginning a recording.If you are entering a patient through the Add New Patient menu,click the New FFR Recording button at the bottom of the menu, andcontinue with Step 4 in this section.2. In the Select Patient menu, click on a patient name.The Patient Summary menu for that patient opens (Figure 3-3 on page 3-4).3. In the Patient Summary menu, click the New FFR Recording button.CAUTION: In order to connect to the correct AO source (Wi-Box) you mustselect the room where the system is being used.The first time you connect to a room, you must enter the room’sinformation into the system. See “Setting up the Wi-Box with theOPTIS Integrated System” on page 4-3 for more information.
Performing an FFR ProcedurePreparing to Record FFRSt. Jude Medical4-6 Part Number ARTUS100109403The screen displays the main screen with the guidance message “Set AO transducerheight to heart level, then open AO transducer to air. Click Zero Pa.”4. Position the AO transducer so that it is level with the patient’s heart.NOTE: The AO transducer should remain level with the patient’s heart throughoutthe procedure.5. Open the AO transducer to air.Figure 4-3: Set AO transducer height and open AO transducer guidance message
Performing an FFR ProcedurePreparing to Record FFRILUMIEN OPTIS SystemInstructions for Use 4-76. In the Pa measurement box, click the Zero button, or on the Table Side Controllerpress the Proximal Marker button. 7. Close the AO transducer.8. Prepare the PressureWire in accordance with the PressureWire Instructions for Useand the on screen prompts.CAUTION: Do not use the PressureWire if there are any signs of damage.9. In the Pd measurement box, click the Connect button, or on the Table Side Control-ler press the Proximal Marker button.NOTE: You have 60 seconds to make the connection between the Pres-sureWire transmitter and the system. If necessary, click the Connectbutton again after the 60 second time-out.Figure 4-4: Flush PressureWire guidance message
Performing an FFR ProcedurePreparing to Record FFRSt. Jude Medical4-8 Part Number ARTUS100109403The system is now looking for a PressureWire. The Pd measurement box shows themessage “Searching.”CAUTION: Do not turn on more than one PressureWire while the system isSearching/Connecting.10. Turn on the PressureWire transmitter.The Pd measurement box shows the message “Connecting” as the PressureWiretransmitter and the system make the wireless connection. Once the connection isestablished, the Pd waveform appears (in green) in the graphical area of the display. NOTE: If the system does not find the PressureWire after one minute, themessage in the Pd measurement box changes back to “No Sensor.”Turn off the PressureWire and return to Step 9.11. Remove the PressureWire from the plastic hoop.12. Insert the PressureWire into the patient in accordance with the PressureWireInstructions for Use.Figure 4-5: Turn on PressureWire guidance message
Performing an FFR ProcedurePreparing to Record FFRILUMIEN OPTIS SystemInstructions for Use 4-9The pressure from the AO transducer and PressureWire must now be equalized.CAUTION: If the PressureWire is turned off or loses power at any pointafter equalization, you must remove it from the patient andre-zero it in its plastic hoop in heparinized saline before continu-ing. See the PressureWire Instructions for Use for more informa-tion on troubleshooting the PressureWire.Figure 4-6: Advance PressureWire and Equalize guidance message
Performing an FFR ProcedurePreparing to Record FFRSt. Jude Medical4-10 Part Number ARTUS10010940313. Check the pressures displayed in the Pa and Pd measurement boxes (See Figure 4-6on page 4-9). If the pressures are not equal, click the Equalize button (or on theTable Side Controller press the Proximal Marker button) to equalize the pressurereading between the AO transducer and the PressureWire. The equalization offset value appears in the Equalization measurement box. Theoffset is applied to the Pd pressure, to match the value of the Pa pressure.CAUTION: If the equalization offset value is greater than orequal to 30, or equal to or lower than -30, the sys-tem displays an alert icon in the Equalizationmeasurement box. If the system displays this alerticon, try the following to reduce the EQ value:• Confirm the AO transducer is positioned at the same heightas the patient's heart and re-equalize.• If the alert remains, remove the PressureWire from thepatient and re-zero it in its plastic hoop in heparinized saline.CAUTION: To prevent incorrect measurement of the aortic pressure by theguiding catheter, causing an incorrect FFR (Pd/Pa) calculation:• Flush any contrast remnants from the guide catheter withheparinized saline.• The insertion tool must be pulled back out of the hemostaticvalve.• The hemostatic valve must be closed during pressure mea-surement.NOTE: The equalization value (EQ) is reset when Pa or Pd is zeroed, orwhen the PressureWire is restarted (turned on/off).
Performing an FFR ProcedureRecording FFRILUMIEN OPTIS SystemInstructions for Use 4-11Recording FFR1. Confirm that the FFR settings are correct for the current procedure. See “FFR Set-tings” on page 2-5 for more information.2. With the PressureWire in position and equalized, advance it across the area to beexamined.The bottom of the graphical area shows the Pd/Pa waveform, along with the Pd/Paratio.3. Induce hyperemia according to standard cathlab procedures.4. Click the Record button (or on the Table Side Controller press the ProximalMarker button).A recording timer is displayed at the bottom of the screen. Click the Mark button(or on the Table Side Controller press the Distal Marker button) to mark an instantFigure 4-7: Pd/Pa waveforms equalizing
Performing an FFR ProcedureRecording FFRSt. Jude Medical4-12 Part Number ARTUS100109403on the recording for later review. A mark appears as a vertical white line on therecording.5. Record pressure until steady state maximum hyperemic condition is reached, untilthe hyperemic effect begins to decrease, or until the physician decides to end therecording. When finished, click the Stop button (or on the Table Side Controllerpress the Proximal Marker button) to end the recording.NOTE: During the recording, you can mark by clicking on the Mark button, or onthe Table Side Controller by pressing the Distal Marker buttonNOTE: Turn off the PressureWire transmitter when it is no longer needed andbefore disposal.CAUTION: When the procedure is complete, handle the PressureWire and allother disposables used during the procedure as potential biohazards.Dispose of in accordance with accepted medical practice and all appli-cable laws and regulations.Figure 4-8: Recording
Performing an FFR ProcedureReviewing an FFR RecordingILUMIEN OPTIS SystemInstructions for Use 4-13Reviewing an FFR RecordingWhen the FFR recording opens, the entire recording is shown. By default, when the recording is opened, the cursor is positioned at the point of the lowest Pd/Pa ratio.WARNING: The system may place the point of FFR at the wrong location due toabnormal heartbeats, for example artifacts in AO (Pa) caused byflushing of guiding catheter or valve opening/closing. The physicianshould always confirm that the point selected by the system is a validpoint for the calculation of FFR.CAUTION: If you have zoomed in on a section of the recording, portions of thewaveform are not displayed (the recording extends off screen). Thephysician should always review the entire unzoomed recording beforeselecting the point for the calculation of FFR.PGFHOKJNACEBLMDTable 4-1: FFR Review ScreenI
Performing an FFR ProcedureReviewing an FFR RecordingSt. Jude Medical4-14 Part Number ARTUS100109403APatient name and ID. See “Entering New Patient Information” on page 3-6 for more information.BRecording date and time.CPrint file to USB button: Available when a USB drive is connected. Click to print the FFR recording file to a USB drive.DExport button: Click to open the Export Wizard.See Chapter 8 “Exporting, Importing, and Managing Files” for more information.ESettings button: Click to open the FFR Settings menu.See “FFR Settings” on page 2-5 for more information.FPa measurement box. Mean Pa value at the cursor is displayed.GPd measurement box. Mean Pd value at the cursor is displayed.HThe FFR value at the cursor.IRestore FFR button: After you have moved the FFR cursor during review; click on Restore FFR to reset it to the location it was at when you opened the recording. NOTE: Upon ending the FFR review, the marker will stay saved to the last point it was on.If it is opened again, the reset button will be grayed out, until the FFR marker isthen again moved. JEnd Review / New Recording : Click the End Review button to close this window and return to the Patient Summary menu.NOTE: While the system is connected to a PressureWire, the button Record appears here.Click the New Recording button to close this review and begin a new FFR record-ing.CAUTION: When closing the recording, the current cursor position and correspond-ing FFR value is saved. When the recording is re-opened, the cursorappears at the saved position. The cursor may then be moved, and the dis-played Pa and Pd pressures and FFR value change to reflect the new cur-sor position.KZoom in/Zoom out of the recording, centered on the cursor.LProcedure list: Click to open a drop-down list of procedures to describe this recording.MVessel list: Click to open a drop-down list of vessels to describe this recording.NMove the cursor to read the Pa, Pd, and FFR value at any point in the recording.OFFR waveformPPa and Pd pressure waveforms
Performing an FFR ProcedurePressureWire TroubleshootingILUMIEN OPTIS SystemInstructions for Use 4-15PressureWire TroubleshootingIn case of low power in the PressureWire, the light on the PressureWireunit flashes yellow, and a low battery indicator appears in the Pd mea-surement box.If there is a problem with your PressureWire, refer to the PressureWireInstructions for Use for details.
Performing an FFR ProcedurePressureWire TroubleshootingSt. Jude Medical4-16 Part Number ARTUS100109403
ILUMIEN OPTIS SystemInstructions for Use 5-1Performing an OCT Procedure 5OverviewThe OCT procedure requires two operators; a sterile operator and a non-sterile operator.All steps requiring contact with the Dragonfly Imaging Catheter or the outside of the ster-ile DOC cover must be performed by the sterile operator. All steps performed within thesterile DOC cover or in direct contact with a keyboard or mouse must be performed bythe non-sterile operator.Required Material and Equipment•OPTIS INTEGRATED System• C7 Dragonfly Imaging Catheter, Dragonfly Duo Imaging Catheter, or DragonflyOPTIS Imaging Catheter• Sterile DOC Cover• 3 mL purge syringe• Contrast media indicated for coronary use, for purging and flush (allow 15 mL foreach run planned)• 0.014 inch guidewire (with torque device if desired)• Guide catheter (6 French, 0.068 inch ID or larger, with no side holes)• Sheath introducer (to match guide catheter)• Hemostatic Y-Adapter/Connector• Heparinized, physiologic saline solution, for hydrophilic catheter preparation• Power injector pump for coronary angiography or manual syringe (capable ofinjecting 4.0 mL /sec for a total of 14 mL in 3.5 seconds)
Performing an OCT ProcedureOverviewSt. Jude Medical5-2 Part Number ARTUS100109403OCT Imaging Overview1. Position - Locate the Dragonfly imaging catheter relative to the target lesion/stent.2. Purge - Clear blood from the catheter lumen, if present, using the attached 3 mLsyringe.3. Puff - Inject a small amount (~ 4 mL) of contrast through the guide catheter to eval-uate clearance.If clarity is marginal, check the orientation of the guide catheter and target vessel.4. Pullback - From Live View, select Enable to start the imaging process.NOTE: In the left coronary system, guide catheter placement and orientation iskey to achieving good contrast flow. This is particularly true in the LCX.
Performing an OCT ProcedureOCT Operating ModesILUMIEN OPTIS SystemInstructions for Use 5-3OCT Operating ModesDuring acquisition, the system is divided into Standby View and Live View.•Standby View - The DOC is not rotating the imaging catheter. The last imageviewed through the catheter lens is shown on the display.•Live View - The DOC is rotating the imaging catheter at low-speed, and is trans-mitting images from the catheter lens to the display.After the image has been recorded, see Chapter 6 “Reviewing OCT Recordings” for moreinformation on reviewing OCT recordings.OCT Recording TypesThe system can make two types of recordings: Pullback (Hi-Res or Survey) and Station-ary. See “Setup - Acquisition Menu” on page 10-2 for more information.NOTE: Hi-Res is a 54 mm pullback recording with double the frame density ascompared with Survey. Survey is a 75 mm pullback recording with stan-dard frame density.NOTE: The instructions in this manual are for Pullback recordings. Differencesfor Stationary recordings are noted where applicable.
Performing an OCT ProcedureOCT Trigger TypesSt. Jude Medical5-4 Part Number ARTUS100109403OCT Trigger TypesAutomatic - The default setting in which the system triggers a pullback automaticallywhen a brief sequence of clear image frames are detected as a result of contrast injection.If the flush injection is not detected within 15 seconds after being enabled, the systemreturns to Live View.Manual - The system does not perform a pullback until the operator clicks the Start Pull-back button on the screen, or presses the Enable button on the DOC. If the flush injectionis not detected within 15 seconds after being enabled, the system returns to Live View.
Performing an OCT ProcedureAngio-CoregistrationILUMIEN OPTIS SystemInstructions for Use 5-5Angio-CoregistrationAngio Co-Registration allows the user to align the angiography and OCT recording sothat OCT frames correlate with the corresponding angiography position. This functional-ity allows the user to more easily determine their position in the OCT relative to the lesionand assists in stent location and placement. Setting up the OPTIS INTEGRATED System1. Position the system for use. See “Positioning the System” on page 2-1.2. Turn on the system. See “Power On System Cabinet” on page 2-3.
Performing an OCT ProcedureSetting up the DOCSt. Jude Medical5-6 Part Number ARTUS100109403Setting up the DOCThe DOC must be readied for use in the sterile environment.CAUTION: Protect the exposed connector inside the DOC from fluids at all times.Fluid contact can disable the DOC and require service.Non-sterile Operator1. With assistance from the sterile operator, place the DOC inside a sterile DOC cover.2. Ensure the cover is extended over the DOC cable to its full length.Sterile Operator3. Connect the flush media (syringe or automated injector) to one port of the guidecatheter manifold (see Figure 5-1).4. Use the following settings to prepare for flush delivery: (This step can also be per-formed by Non-Sterile Operator)• 4 ml/sec or less flush rate.• 14 ml or less total flush volume.• If using an automated injector, pressure limit 300 psi, or the nearest availablesetting.5. Purge all air from the tubing and manifold following standard practice.Figure 5-1: DOC ConnectionsDOCPatientManifold Dragonfly DOC FromContrast Injection Line Guide 3 mL SyringeCatheter To OPTISIntegratedCableImaging CatheterContrast Source Contrast PurgeGuidewireSterile Field Non-sterile FieldSystem
Performing an OCT ProcedureSetting up the Dragonfly Imaging CatheterILUMIEN OPTIS SystemInstructions for Use 5-7Setting up the Dragonfly Imaging CatheterWARNING: Prior to use, please review the Instructions for Use supplied with theDragonfly Imaging Catheter for more information.1. Inspect the packaging of the catheter for damage. Ensure that the catheter has notpassed its expiration date.CAUTION: Do not use the catheter if the sterile packaging is compromised.2. Using sterile technique, carefully remove the Dragonfly catheter from its sterilepackage.3. Carefully remove the catheter from the plastic hoop and examine it for visible dam-age or defects.CAUTION: Do not use the catheter if there are any signs of damage.4. Moisten the distal segment of the catheter from the tip to approximately 100 cmproximally using heparinized saline to ensure optimal performance of the hydro-philic coating.CAUTION: Use heparinized saline only. 5. Remove the cap from the sidearm luer and attach a 3 ml syringe filled with 100%contrast.CAUTION: Take care in handling the Dragonfly to prevent breaking thefiber-optics within the catheter. Kinking and bending of thecatheter can cause damage. While connecting, ensure the proxi-mal catheter segment is straight and aligned with the DOC.Never attempt to connect and operate the catheter while thecatheter remains coiled within the hoop.
Performing an OCT ProcedurePreparing to Acquire OCT RecordingsSt. Jude Medical5-8 Part Number ARTUS100109403Preparing to Acquire OCT RecordingsNew OCT recordings are started from the Patient Summary menu.1. If necessary, enter the patient’s information. See “Entering New Patient Informa-tion” on page 3-6.NOTE: Patient information should be entered into the system and selectedfor use before beginning a recording.If you are entering a patient through the Add New Patient menu,click the New OCT Recording button (located at the bottom of Step2 of the Add New Patient wizard), and continue with Step 4 below.2. In the Select Patient menu, click on the patient.The Patient Summary menu for that patient opens (Figure 3-3 on page 3-4).3. In the Patient Summary menu, click the New OCT Recording button.NOTE: If necessary, enter Physician name and Accession number for thiscase, and click OK.4. If Flush Medium was set to anything other than Contrast for the previous patient,the setting is changed back to Contrast and an alert appears.The system will ask you to confirm or choose another flush medium, then click OKto close the alert. If you need to change the Flush Medium setting, see “ConfirmRecording Settings” on page 5-12.
Performing an OCT ProcedurePreparing to Acquire OCT RecordingsILUMIEN OPTIS SystemInstructions for Use 5-95. The screen displays the guidance message “Purge catheter with contrast” (Figure5-2).NOTE: To prevent this guidance message from appearing, check the box next tothe message “Do not show this screen again.”6. Purge the Dragonfly Imaging Catheter's lumen with 100% contrast media from the3 ml syringe to remove all air from the catheter. Flush until 3-5 drops exit from thecatheter's distal tip. Do not remove the syringe from the catheter purge port afterflushing.CAUTION: The catheter must be purged prior to connection to the DOC.Figure 5-2: Purge Catheter guidance message
Performing an OCT ProcedurePreparing to Acquire OCT RecordingsSt. Jude Medical5-10 Part Number ARTUS1001094037. Once the 100% contrast media has been injected, click the Next button.The screen displays the guidance message “Plug catheter into DOC” (Figure 5-3).8. Insert the hub of the catheter into the port of the DOC, and twist the hub clockwiseuntil secure (1/8 turn).Figure 5-3: Plug Catheter into DOC Guidance MessageFigure 5-4: Dragonfly Catheter Connected to the DOCLock LED
Performing an OCT ProcedurePreparing to Acquire OCT RecordingsILUMIEN OPTIS SystemInstructions for Use 5-11CAUTION: Do not insert or remove the catheter while the DOC is scanning. Do not attempt to disconnect the catheter from the DOC while the“lock” LED is blinking as it could damage the catheter or the DOC. The DOC's “lock” LED flashes and lights as the DOC automatically makes theinternal optical fiber connection, and the green Connecting imaging catheterprogress bar at the bottom of the screen completes.NOTE: If the Connection Failure alert appears, unload the catheter (pressunload on the DOC) and try to load the catheter again. If this alertappears again, replace the catheter.NOTE: If the connection or initial calibration is stopped, the ConnectionCancelled alert is displayed. If this alert appears, unload the catheter(press unload on the DOC), click OK, and try to load the catheteragain.On screen, the size and position of the outer sheath of the catheter is adjusted withrespect to the calibration marks (see Figure 5-5).When the connection and initial calibration are complete, the confirmation mes-sage, Catheter connected, appears. The system goes into Standby View.Figure 5-5: Catheter Connected, Initial Calibration done
Performing an OCT ProcedureConfirm Recording SettingsSt. Jude Medical5-12 Part Number ARTUS100109403Confirm Recording SettingsAfter the catheter has been connected to the DOC, confirm all settings for this recording. 1. Click the Settings button at the top of the screen.A context-sensitive Settings menu opens on the right. Additional pullback settings are displayed in the menu on the left. For AngioCo-Registration, click on the Acquire Angio button. Angiography video inputmust be present for the Acquire Angio button to become live.2. Confirm all settings are correct for this recording.NOTE: If Flush Medium has been restricted to Contrast Only, you cannotchange the Flush Medium setting. See “Setup - Acquisition/OtherMenu” on page 10-4 for more information. If Recording Type has been set to Stationary, you cannot change thePullback Length setting. See “Setup - Acquisition Menu” on page10-2 for more information.CAUTION: To obtain accurate measurements, be sure the selection for theFlush Medium is the same as the medium in which you are imag-ing.NOTE: Only 100% contrast media is approved for human OCT Imaging.NOTE: Click the Menu button at the bottom of the screen to open theOPTIS INTEGRATED System Setup dialog box. See Chapter 10“User Interface Reference” for more information.Figure 5-6: OCT Settings Menu (during Recording)
Performing an OCT ProcedureDragonfly Imaging Catheter Insertion and PositioningILUMIEN OPTIS SystemInstructions for Use 5-13Dragonfly Imaging Catheter Insertion and PositioningThe guide catheter and guidewire must be inserted into the patient per normal clinicalprocedures prior to insertion of the Dragonfly Imaging Catheter. The Dragonfly cathetermust be properly inserted into the guide catheter to ensure patient safety and proper oper-ation. Once the Dragonfly catheter has been inserted, its location, and the position of the guidecatheter, may be fine-tuned to ensure optimal imaging.CAUTION: Ensure that no air is introduced into the system during the imagingcatheter insertion.1. Ensure that the Dragonfly catheter is not rotating (press Standby View if necessary)before the sterile operator begins loading and inserting. If desired, select a Vesseland Procedure from the fields at the bottom of the screen.2. Back-load the Dragonfly catheter's rapid-exchange lumen onto the indwelling0.014 inch guidewire.3. POSITION the catheter according to your catheter’s Instructions for Use.CAUTION: Observe all advancement and movement of the Dragonfly Imag-ing Catheter under fluoroscopy. Always advance and withdrawthe catheter slowly. Failure to observe device movement fluoro-scopically may result in vessel injury or device damage. Toensure proper placement, do not move the guidewire after theDragonfly catheter is in place.If resistance is encountered during advancement of the Dragon-fly Imaging Catheter, stop manipulation and evaluate under flu-oroscopy. If the cause of resistance cannot be determined ormitigated, carefully remove the catheter and guidewire as a unitfrom the patient.Leave the guidewire engaged with the catheter at all times dur-ing use. Do not withdraw or advance the guidewire prior to with-drawing the catheter.4. Press the Live View button to start live-scan imaging (low-speed rotation of theimaging core).The ring around the Live View button on the DOC lights in green.
Performing an OCT ProcedureDragonfly Imaging Catheter Insertion and PositioningSt. Jude Medical5-14 Part Number ARTUS100109403CAUTION: Monitor the OCT image for indications of catheter optical fail-ure. If optical failure is suspected, return to Standby View (clickthe Standby View button), remove the catheter, and replace itwith a new one.NOTE: A pullback can not be started unless the optical fiber is fullyadvanced.5. Calibrate either by pressing the Auto Calibrate button or by using the ManualCalibration buttons. You can also Auto Calibrate by pressing the Enable buttonon the DOC.6. Verify calibration as follows:The image is correctly calibrated when the outermost “ring” of the catheter is cen-tered between the 4 calibration marks. NOTE: Ensure accurate calibration prior to a recording. Incorrect calibrationmay cause early pullback initiation and incorrect measurements.Figure 5-7: Incorrect and Correct Calibration (Dragonfly Duo shown in fingertips)Incorrect Incorrect CorrectIncorrect Incorrect CorrectFigure 5-8: Incorrect and Correct Calibration (Dragonfly OPTIS shown in fingertips) Metallic Coating Layer
Performing an OCT ProcedureDragonfly Imaging Catheter Insertion and PositioningILUMIEN OPTIS SystemInstructions for Use 5-15You should adjust the calibration to the best approximate sizebetween the outer diameter of the catheter and the 4 calibrationmarks. • To calibrate automatically, press the Auto-calibrate button. In the ImageWindow, the position of the catheter outer sheath is adjusted close to its finalcorrect position with respect to the four calibration marks.• If necessary, click the Increase/Decrease buttons to calibratemanually.7. PURGE the Dragonfly Imaging Catheter by injecting ~0.1 ml contrast using the3 ml syringe to ensure no blood has diffused into the catheter lumen.NOTE: Application of negative pressure to draw blood into the catheter isnot recommended. Blood in the catheter lumen will obscure theimage and can be difficult to completely purge.8. Ensure the guide catheter is oriented to preferentially direct contrast flow to the tar-get artery, and verify angiographically that adequate flow of contrast is delivered tothe artery.NOTE: PUFF-- Injecting a small “puff” of contrast while reviewing theimage on screen to verify that adequate flow of contrast is deliveredto the artery.9. The operator can inject the media either by manual flush or automated injector. Ifusing an automated injector, verify the following for flush delivery: • 4 ml/sec or less flush rate.• 14 ml total flush volume.• If using an automated injector, pressure limit 300 psi, or the nearest availablesetting.10. Verify the stopcock position on the manifold is set to allow flow from the injectionpump into the guide catheter.
Performing an OCT ProcedureAcquiring Patient ImagesSt. Jude Medical5-16 Part Number ARTUS100109403Acquiring Patient ImagesThe System Display during image acquisition is shown in Figure 5-9.Table 5-1: System Display Description - AcquisitionPatient Information Displays the Patient name and ID.Image Window This display shows the current view by the imaging catheter lens.Recording Calibration Marks Recording calibration marks, measured in mm. Note: In a Stationary recording, this is a timeline, measured in sec-onds. See “Setup - Acquisition Menu” on page 10-2 to set the Recording Type to Stationary.Depth Calibration Marks Depth of the scan in mm.L-Mode display This displays the approximate lateral appearance of the vessel being scanned.Note: In a Stationary recording, the “L-Mode” is renamed “Time-line.”Recording (in progress) Displays the recording as it is completed.Recording (in progress)RecordingCalibrationMarksL-Mode Display Figure 5-9: System Display - AcquisitionImage WindowDepthPatient InformationCalibrationMarks
Performing an OCT ProcedureAcquiring Patient ImagesILUMIEN OPTIS SystemInstructions for Use 5-17NOTE: If you are performing a Stationary recording, the Enable Pullback andStart Pullback buttons are replaced with a Start Recording button. Donot click the Start Recording button until you have notified the personinjecting the contrast media that the system is ready. Click the StartRecording button (or Sterile Operator press the Enable button on theDOC) after the contrast is injected. The recording begins immediately.1. With the system in Live View, calibrate either by pressing the Auto Calibrate but-ton or by using the Manual Calibration buttons. Click the Enable Pullback but-ton (or Sterile Operator press the Enable button on the DOC) to allow the system todetect initiation of the imaging flush. You have 15 seconds to initiate the flush for the pullback. NOTE: When acquiring the angiographic images for co-registration withcorresponding OCT recording, the imaging equipment must be sta-tionary throughout the cineangiography. For best results, choose theview that reduces occurrences of vessel foreshortening and branchoverlapping. This should minimize co-registration inaccuracies.2. Notify the person injecting the contrast media that the system is enabled.3. Begin contrast media injection (by manual flush or automated power injection).The system automatically begins a recording once a brief sequence of clear imageframes are detected indicating the area is flushed with contrast media.NOTE: If Trigger Type is set to Manual, click the Start Pullback button orpress the Enable button on the DOC to initiate pullback.NOTE: If the Recording Type is set to Pullback, the recording takesapproximately 3 seconds. If set to Stationary, the recording takesapproximately 6 seconds.NOTE: To use Angio Co-Registration with this recording, first click on theAcquire Angio button, then step and stay on the Cine Pedal whilesimultaneously capturing the entire pullback recording. Step off theCine Pedal upon completion of the pullback.If the Automatically review recordings option is enabled, the image file is dis-played for review.Review the recording and repeat pullback procedure if needed. If the catheter is still con-nected to the DOC, the New Recording button will be available at the bottom of thescreen.
Performing an OCT ProcedureRemoving the Dragonfly Imaging CatheterSt. Jude Medical5-18 Part Number ARTUS100109403Removing the Dragonfly Imaging CatheterAll information obtained during imaging is automatically saved with the recording. Onceimaging is completed, the data and images may be reviewed (see Chapter 6 “ReviewingOCT Recordings”) or transferred to removable media for review on a St. Jude MedicalOffline Review Workstation (see Chapter 8 “Exporting, Importing, and ManagingFiles”).1. Ensure that the Dragonfly catheter is not rotating (click on the Standby View but-ton if necessary) before the sterile operator begins withdrawal and unloading.2. When all OCT imaging is complete, withdraw the Dragonfly catheter into the guidecatheter under fluoroscopic observation.CAUTION: If resistance is encountered during withdrawal of the DragonflyImaging Catheter, stop manipulation and evaluate under fluo-roscopy. If the cause of resistance cannot be determined or miti-gated, carefully remove the catheter and guidewire as a unitfrom the patient.3. Remove the Dragonfly catheter from the guide catheter and guidewire.4. Disconnect the Dragonfly catheter from the DOC by pressing the Unload button.When the “lock” LED stops flashing, the catheter is disconnected internally. Twistthe catheter hub counter-clockwise to disengage it from the DOC.CAUTION: Handle the Dragonfly Imaging Catheter and all other dispos-ables used during the procedure as potential biohazards. Dis-pose of in accordance with accepted medical practice and allapplicable laws and regulations.
Performing an OCT ProcedureTroubleshooting OCT AcquisitionILUMIEN OPTIS SystemInstructions for Use 5-19Troubleshooting OCT AcquisitionImmediately Stopping DOC Operation1. Press the Stop button on the DOC at any time to immediately stop operation of theDOC. Pressing this button:• Turns off the DOC motors, thereby stopping all optical fiber movement, bothrotational and longitudinal.• Turns off the Imaging Engine light source.• Stops recording and freezes the image. If Automatically review recordingsis checked in the Configure tab of the Setup dialog box, it automaticallyplays back the recording once it has been saved.• Prevents the imaging catheter lens from automatically advancing to its origi-nal distal position. 2. The system computer remains on and the system is available for new operations.CAUTION: If the catheter was stopped before returning to its fully advanced posi-tion, the system displays an alert: Catheter Must Be Advanced to Con-tinue. Click the Advance Catheter button to advance the optical fiberwithin the catheter. You must advance the catheter before makinganother OCT recording.
Performing an OCT ProcedureTroubleshooting OCT AcquisitionSt. Jude Medical5-20 Part Number ARTUS100109403Catheter FailureNOTE: These events can only occur if a catheter is connected to the DOC.In the event of an imaging catheter failure (complete break of the optical fiber) duringeither pullback or advance, the system stops automatically (and stops pullback/advance)and displays the following message: CAUTION: Do not click the OK button until after you have removed theDragonfly Imaging Catheter from the patient.1. Withdraw the Dragonfly into the guide catheter under fluoroscopic observation.CAUTION: If resistance is encountered during withdrawal of the Dragonfly cath-eter, stop manipulation and evaluate under fluoroscopy. If the cause ofresistance cannot be determined or mitigated, carefully remove thecatheter and guidewire as a unit from the patient.2. Remove the Dragonfly catheter from the guide catheter and guidewire.3. Acknowledge the alert by clicking on OK.Figure 5-10: Catheter Failure message
Performing an OCT ProcedureTroubleshooting OCT AcquisitionILUMIEN OPTIS SystemInstructions for Use 5-21After acknowledging the alert, the Safe Unload Guidance displays as shown below.4. Turn the catheter hub 1/4-turn counter-clockwise as directed. While the DOC isunloading the catheter, the Guidance displays the screen below:Figure 5-11: Safe Unload Guidance, Screen 1Figure 5-12: Safe Unload Guidance, Screen 2
Performing an OCT ProcedureTroubleshooting OCT AcquisitionSt. Jude Medical5-22 Part Number ARTUS1001094035. When the DOC is finished unloading the catheter, the Guidance displays the screenbelow:6. Remove the existing Dragonfly Imaging Catheter in the normal manner. ClickNext.7. Load a new Dragonfly Imaging Catheter in the normal manner.Figure 5-13: Safe Unload Guidance, Screen 3
ILUMIEN OPTIS SystemInstructions for Use 6-1Reviewing OCT Recordings 6NOTE: Making measurements, calculations, and text annotations is covered inChapter 7 “Measurements and Annotations”. Exporting images is coveredin Chapter 8 “Exporting, Importing, and Managing Files”.
Reviewing OCT RecordingsImage WindowSt. Jude Medical6-2 Part Number ARTUS100109403Image WindowWhen reviewing recordings, the Image Window shows a cross-section of the pullback orstill frame (Table 6-1).Table 6-1: OCT Display OverviewAPatient name and ID. See “Entering New Patient Information” on page 3-6 for more information.BRecording date and time.CCapture button: Available on a still frame or paused recording. Click to save the current frame.DPrint button: Available when a USB drive is connected and the system is displaying a still frame or paused recording. Click to print the current frame to file.See “Printing Still Images” on page 6-13 for more information.EExport button: Click to open the Export Wizard.See Chapter 8 “Exporting, Importing, and Managing Files” for more information.FSettings button: Click to open the (Playback) Settings menu.See “Adjust Playback Settings” on page 6-9 for more information.GFrame number: Only visible on a paused recording when Tool Panel is closed.ADFGHJLPSBCMNO KQER
Reviewing OCT RecordingsImage WindowILUMIEN OPTIS SystemInstructions for Use 6-3HTool Panel containing Measurement and Annotation tools: Use these to add measurements, calculations, and add text to recordings and still images.See Chapter 7 “Measurements and Annotations” for more information.JBookmark controls: Add bookmarks to the L-Mode view.See “Bookmark Controls” on page 6-10 for more information.KEnd Review / New Recording : Click the End Review button to close this window and return to the Patient Summary menu. See “Patient Summary Menu” on page 3-4 for more information.NOTE: While the OPTIS INTEGRATED System is connected to a Dragonfly imaging cathe-ter, the button New Recording appears here. Click the New Recording button toclose this review and begin a new OCT recording.LPlayback controls: Control the playback of the OCT recording. Not available with still images.See “Playback Controls” on page 6-6 for more information.MProcedure list: Click to open a drop-down list of procedures to describe this recording.NVessel list: Click to open a drop-down list of vessels to describe this recording.OMenu: Displays the context-sensitive menu. Click to access the Setup and playback Cali-bration controls. See Chapter 10 “User Interface Reference” for more information on the Setup Menu; see “Calibration Adjustment” on page 6-7 for more information on the Cali-bration Menu.PL-Mode view: An approximate lateral representation of the vessel for this recording. Not available with still images.See “L-Mode View” on page 6-4 for more information.QImage Window: A cross-section view of the vessel.RView Panel: Control display features including L-Mode and optional features such as 3D and Lumen Profile. SMeasurements Panel: This section lists measurements from the current image; click on a measurement to highlight it in the Image Window.
Reviewing OCT RecordingsL-Mode ViewSt. Jude Medical6-4 Part Number ARTUS100109403L-Mode ViewNOTE: If reviewing a Stationary recording, the L-Mode display is renamed Time-line. The Timeline represents the stationary view of the catheter during thesix seconds of recording.During the OCT pullback recording, the system captures evenly spaced cross-sectionimages and uses them to construct a lateral view of the vessel anatomy. The lateral viewis shown in the L-Mode display in the lower portion of the screen; the distal portion of therecording is to the left.NOTE: The width of the L-Mode window represents the entire range of the record-ing.Table 6-2: L-Mode viewACut-Plane Indicator. BL-Mode display.CCurrent Frame Indicator. Click and drag this to change the lateral view shown in the L-Mode display.BAL-ModeView TabC
Reviewing OCT RecordingsL-Mode ViewILUMIEN OPTIS SystemInstructions for Use 6-5Limitations of L-Mode DataPlease be aware of the following limitations of L-Mode data:• Due to the catheter’s arbitrary position within the vessel, L-Mode data may not berepresentative of the actual vessel lumen.• The vessel diameter shown in the L-Mode reconstruction may appear significantlysmaller than the actual diameter when the catheter position is off center and close tothe vessel wall. To avoid misinterpreting the image when this occurs, rotate the cut-plane to examine all views of the L-Mode.• Although a vessel may curve, the L-Mode view always appears straight because ofthe limitations of reconstruction.• Artifacts caused by the relative motion of the catheter and the vessel often result ina saw-toothed appearance of the reconstruction and can lead to misinterpretation byinexperienced users.• Shortening or lengthening artifacts in the L-Mode reconstruction may occur due tothe relative motion of the Dragonfly catheter with respect to the coronary arterycaused by the patient’s heart motion.
Reviewing OCT RecordingsPlayback ControlsSt. Jude Medical6-6 Part Number ARTUS100109403Playback ControlsTable 6-3: Playback ControlsAMenu: Displays the context-sensitive menu. Click to access the Setup and playback Calibration controls. Only available with a still image or paused recording.BVessel list: Click to open a drop-down list of vessels to describe this recording.CProcedure list: Click to open a drop-down list of procedures to describe this recording.DStep Backward : Click to move the recording back one frame at a time. Click and hold this button to move back rapidly. Not available with still images.EPlay/Pause : Plays or Pauses the recording. If you pause a recording, the frame number is displayed in the upper right corner of the image area. Not available with still images.FStep Forward : Click to move the recording forward one frame at a time. Click and hold this button to move forward rapidly. Not available with still images.GEnd Review / New Recording : Click the End Review button to close this window and return to the Patient Summary menu.NOTE: While the system is connected to a Dragonfly Imaging Catheter, the buttonNew Recording appears here. Click the New Recording button to closethis review and begin a new OCT recording.A E F GB C DXX
Reviewing OCT RecordingsCalibration AdjustmentILUMIEN OPTIS SystemInstructions for Use 6-7Calibration AdjustmentUse the Adjust Calibration tool to adjust the calibration of the recording.1. Use the Playback Controls at the bottom of the screen to pause the playback.2. Hover or click on the Menu button at the bottom of the screen and select the Cali-bration option.The Calibration tool opens. The image is zoomed and the calibration circle withtwo control points is sized approximate to the outside diameter of the catheter.3. Click and drag on the control points until the calibration circle traces the outsidediameter of the catheter as shown in the sample picture at the bottom of the screen.NOTE: Adjustments made here are for size, not alignment. The catheter maynot appear centered in all frames during playback. This is normal.4. Click the Accept button save the calibration, or click Cancel to close the calibrationtool without saving the adjustment.Figure 6-1: Playback Calibration (DragonFly Duo shown, in progress)
Reviewing OCT RecordingsCalibration AdjustmentSt. Jude Medical6-8 Part Number ARTUS100109403NOTE: If necessary, you can return the recording to its default calibration byclicking the Remove Adjustment button.If you remove or change the calibration, any changes that you havemade to the automatically-generated Lumen Profile contours arereset. See “Lumen Profile Display Option” on page 7-20 for moreinformation.
Reviewing OCT RecordingsAdjust Playback SettingsILUMIEN OPTIS SystemInstructions for Use 6-9Adjust Playback Settings1. Click the Settings button at the top of the screen.A context-sensitive menu opens.2. Click and drag the Playback Speed slider bar to set the playback speed.3. Click and drag the Rotation slider bar to rotate the image shown in the cross-sec-tion view.NOTE: When an image is rotated, the L-Mode cut-plane marker (if visible)and any displayed measurements and annotations are also rotated.4. Click and drag the Black level and White level slider bars to set the black and whitebalance in the image.5. Click the arrow on the Field of View drop-down menu to display the list of diame-ter sizes.The default setting is 7.0 mm.The Field of View setting controls the size of the image displayed on screen. Asmaller Field of View setting equals a larger magnification. Click a size to select it.NOTE: Clicking on the image will also change the zoom level. See “Quick Zoom”on page 7-16.Figure 6-2: Field of View SettingsField of View 10.0 mm Field of View 5.0 mm
Reviewing OCT RecordingsBookmark ControlsSt. Jude Medical6-10 Part Number ARTUS100109403Bookmark ControlsThe System allows you to add bookmarks to mark frames for further review.NOTE: Bookmark controls are only available when an L-Mode view is displayedin a recording.Table 6-4: Bookmark ControlsAAdd/Remove Bookmark : Applies or removes a bookmark from the current frame. After a bookmark has been applied to a frame, the position of the bookmark is indicated in the L-Mode view with a green triangle.Click on a bookmark indicator to jump to the bookmarked frame.NOTE: Frames with measurements and annotations are bookmarked automatically.See Chapter 7 “Measurements and Annotations” for more information.BPrevious Bookmark : Seeks backward to the previous bookmarked frame. If there are no previous bookmarks, it continues seeking from the end of the recording. Unavailable if there are no bookmarks.CNext Bookmark : Seeks forward to the next bookmarked frame. If there are no subse-quent bookmarks, it continues seeking from the beginning of the recording. Unavailable if there are no bookmarks.DClear All Bookmarks : Clears all bookmarks from the current recording. Unavailable if there are no bookmarks.ABCD
Reviewing OCT RecordingsSetting Playback RangeILUMIEN OPTIS SystemInstructions for Use 6-11Setting Playback RangeBy default, the system plays the entire length of a pullback during the review. You canshorten the length of the playback by moving the ends of the playback range.NOTE: Playback range markers are only available on recordings in the L-Modeview. By default, they are at the distal and proximal ends of the recording.To change the playback range:1. Use the Playback Controls at the bottom of the screen to pause the playback.2. Click on the range markers (purple triangles) and position them before and after thearea to be played during review.NOTE: If the recording is exported as an AVI file, this range determines the lengthof the exported recording.NOTE: If the L-Mode view is changed (for example, turned Off), the playbackrange is restored to the full length of the recording.Playback Range markersCurrent Frame IndicatorFigure 6-3: Adjusted Playback Range
Reviewing OCT RecordingsExporting a Recording or Still FrameSt. Jude Medical6-12 Part Number ARTUS100109403Exporting a Recording or Still FrameRefer to Chapter 8 “Exporting, Importing, and Managing Files” for more informa-tion on exporting a recording or still frame.Capturing Still ImagesYou can use the Capture button to save a still image from a recording, or to savea copy of an existing still frame. All measurements and annotations on that screenare saved with the captured image.NOTE: The Capture button is unavailable while a recording is playing. Pause theplayback at the frame that you want to capture.Saving a Still Image1. Display the frame that you want to capture.2. Click the Capture button.A confirmation message appears, and the captured image appears in the PatientSummary menu.NOTE: The still image is saved with the same date as the source file. It isgrouped in the Patient Summary menu with other recordings andimages of the same date.In the Patient Summary menu, the system adds the frame number to the title of thecaptured image (for example, “OCT Frame 145”).
Reviewing OCT RecordingsPrinting Still ImagesILUMIEN OPTIS SystemInstructions for Use 6-13Printing Still ImagesYou can use the Print button to print the current screen (including still frame,L-Mode, and any visible annotations) to an attached USB drive. All measurementsand annotations on that screen are saved with the captured image.NOTE: The Print button is unavailable while a recording is playing. Pause theplayback at the frame that you want to print.NOTE: If you are printing the file to a USB drive, you can set the file format. See“Setup - Print Menu” on page 10-25 for more information.Printing a Still Image1. Display the frame that you want to print.2. Click the Print button.A confirmation message appears, and the file is saved on the attached USB drive.
Reviewing OCT RecordingsReviewing with Angio-CoregistrationSt. Jude Medical6-14 Part Number ARTUS100109403Reviewing with Angio-CoregistrationOnly pullback images that contain angio-coregistration data can be used for this type ofreview. Identify the presence of angio-coregistration data by locating a black and whiteangiographic thumbnail image in the upper-left corner of the pullback on the PatientSummary screen. 1. From the Patient Summary screen, identify a pullback that contains a black andwhite angiographic thumbnail image in the upper-left corner.2. Click the review button. The OCT review begins to playback. Figure 6-4: Angio-Coregistration Thumbnail Image
Reviewing OCT RecordingsReviewing with Angio-CoregistrationILUMIEN OPTIS SystemInstructions for Use 6-153. Pause the recording and click the Angio Co-Registration button under the Viewmenu to initiate the Angio Co-Registration process. The angiography displays inthe left window.NOTE: To view the angiography along with the MLA data, click the MLAbox in the View menu. Mean Diameter or Area is automaticallyselected when MLA is clicked.Figure 6-5: View Menu, Angio Co-Registration Button
Reviewing OCT RecordingsReviewing with Angio-CoregistrationSt. Jude Medical6-16 Part Number ARTUS1001094034. Click on the Register button to initiate the co-registration. Step 1 of the AngioCo-Registration Guidance displays.Figure 6-6: Angio Co-Registration: RegisterFigure 6-7: Angio Co-Registration Guidance, Step 1
Reviewing OCT RecordingsReviewing with Angio-CoregistrationILUMIEN OPTIS SystemInstructions for Use 6-175. Set the first (distal) control point by placing the cursor in the vessel of interest, onthe guidewire (or just proximal of the guidewire), and clicking. A white controlpoint and Step 2 of the Angio Co-Registration Guidance displays.6. Moving distal to proximal, set at least one additional control point by placing thecursor in the vessel of interest, distally near the guide catheter tip and clicking.Additional white control point(s) display. The system draws a line which traces thevessel of interest and connects the control points. The Continue button displays.Figure 6-8: Angio Co-Registration Guidance, Step 2
Reviewing OCT RecordingsReviewing with Angio-CoregistrationSt. Jude Medical6-18 Part Number ARTUS100109403NOTE: If after placing the proximal point, an incorrect vessel path is traced,click the Undo button, then replace the proximal control point. Fol-low the on-screen guidance.7. Verify that the trace is in the vessel of interest. Click the Continue button. AngioCo-Registration Guidance, Step 3 displays.Figure 6-9: Angio Co-Registration Guidance, Step 2 with Trace
Reviewing OCT RecordingsReviewing with Angio-CoregistrationILUMIEN OPTIS SystemInstructions for Use 6-198. Click the Confirm button to accept the path within the vessel of interest. ThePlease wait for co-registration screen displays while the system correlates theangiography with the OCT frames. When the co-registration is complete, theCoregistration completed successfully screen displays.NOTE: If either the selected proximal or distal points do not allow the sys-tem to generate a full Angio Co-Registration, a Warning screen dis-plays. Click Cancel. Following the on-screen guidance, replace bothdistal and proximal control points along the vessel of interest, thenclick the Confirm button.Figure 6-10: Angio Co-Registration Guidance, Step 3
Reviewing OCT RecordingsReviewing with Angio-CoregistrationSt. Jude Medical6-20 Part Number ARTUS1001094039. Click the Accept button to use the successful Angio Co-Registration. The mainscreen displays the co-registered images.Figure 6-11: Angio Co-registration completed successfully screenFigure 6-12: Main Screen showing Angio Co-Registration
Reviewing OCT RecordingsReviewing with Angio-CoregistrationILUMIEN OPTIS SystemInstructions for Use 6-21NOTE: To use the Quick Zoom feature (see “Quick Zoom” on page 7-16) onthe Angiography window, simply click on the angiography image.
Reviewing OCT RecordingsReviewing with Angio-CoregistrationSt. Jude Medical6-22 Part Number ARTUS100109403
ILUMIEN OPTIS SystemInstructions for Use 7-1Measurements and Annotations 7Measurements and Text Callouts in the Image FilesMeasurements and text callouts that are added to images do not change the underlyingimage data. The unannotated image is always preserved and can be reviewed without themeasurements and callouts. All measurements and annotations added during the proce-dure are preserved in the file.Measurements and text callouts can be modified or deleted, and pen color, line width andpoint size can be set. In addition, pen color can be set to automatically cycle so that sub-sequent measurements are displayed in different colors. For information on setting pencolor, line width, and point size, see “Setup - Measurements/Labels Menu” on page10-24.CAUTION: If you want to make measurements on files which will be exported tostandard formats, you must make the measurements BEFOREexporting the images. Using non-OCT software to measure standardformat images will not produce accurate measurements.CAUTION: Do not use images that have been exported to JPEG or CompressedAVI formats for clinical decision making. These formats use compres-sion methods that may degrade the image quality.NOTE: All measurements and calculations can be made in the cross-section viewof the OCT image, but only horizontal length measurements and text anno-tations can be made in the L-Mode view.
Measurements and AnnotationsMeasurement and Annotation ToolsSt. Jude Medical7-2 Part Number ARTUS100109403Measurement and Annotation ToolsWhen the OCT playback is paused, or displaying a stillimage, the measurement and annotation tools can beaccessed on screen by hovering over the Tools Panel(wrench symbol). As measurements are added to theimage, they are labeled with successive control letters(A, B, C, etc., up to 26 measurements per frame).NOTE: Tools appear black when they areunavailable.NOTE: After a measurement or text annotation has beenapplied to a frame, the position of the bookmarkis indicated in the L-Mode view with a green tri-angle.Click on a bookmark to jump to it.Table 7-1: Measurement and Annotation Tool FunctionsArea - Multiple Points : Manually place points to trace and measure an area on a frame. This also generates the min., max., and mean diameter measurements for the given area.Length : Make a distance measurement on a frame.Text... : Opens the Enter Note menu to enter text at the cursor position.%AS (Percent Area Stenosis) : Calculates the relative size of two areas drawn in the current frame.NOTE: If there are fewer than two areas on the current frame, this button is not available.%DS (Percent Diameter Stenosis) : Calculates the relative size of two lengths (or diameters) drawn in the current frame.NOTE: If there are fewer than two lengths on the current frame, this button is not available.Zoom - / Zoom + : Switches between zoom levels. See “Adjust Playback Settings” on page 6-9 for more information.Delete All Annotations : Click to delete all annotations and measurements.Figure 7-1: Tools
Measurements and AnnotationsVerifying CalibrationILUMIEN OPTIS SystemInstructions for Use 7-3Verifying CalibrationBefore making measurements, you must verify the calibration. If the calibration for thisrecording or still image has not been adjusted, or if it has been reset, the calibration toolappears when you begin to take a measurement. See “Calibration Adjustment” on page6-7 for more information.Once the calibration is accepted, you can begin taking measurements. NOTE: Calibration before making measurements should not be necessary whenusing the Dragonfly OPTIS catheter. The OPTIS Integrated software inconjunction with the Dragonfly OPTIS catheter uses Continuous Calibra-tion technology to eliminate the need for this step in the workflow.Techniques to Improve Measurement AccuracyFollow these guidelines to improve measurement accuracy:• Before making measurements, use the Zoom function to zoom into the region ofinterest until you can clearly see borders and other features you want to measure(see “Field of View” on page 7-14).• Place the measurement cursor correctly on the image, using the same measurementtechnique each time you perform the same type of measurement.• Avoid making measurements in areas that have artifacts that disguise tissue.Measurements and Annotations in the L-Mode ViewAll annotations and measurements are typically made in the cross-section view area of theImage Window. Only horizontal measurements, useful for determining pullback distance,are permitted in the L-Mode view.CAUTION: Artifacts may result in misrepresentation of L-Mode data, so L-Modeis not recommended for quantization of clinical information.
Measurements and AnnotationsLength MeasurementsSt. Jude Medical7-4 Part Number ARTUS100109403Length MeasurementsThe system calculates and displays length as the distance in millimeters (mm)between 2 points placed on an image in either the cross-section or L-Mode views.Figure 7-2: Length Measurement
Measurements and AnnotationsLength MeasurementsILUMIEN OPTIS SystemInstructions for Use 7-5Making a Length (Distance) Measurement1. Select the still image or paused recording that you want to measure.2. Click on the Length button (Figure 7-2). The cursor changes to a pen.3. Click anywhere in the Image Window (cross-section view or L-Mode view) toplace the starting point for the length measurement.NOTE: Both start and end points must be in the same view. Forexample, if the starting point is placed in the cross-sectionview, the end point must also be in the cross-section view.To cancel the measurement, press the <Esc> key or clickthe Cancel button.4. Use the mouse to position the pen cursor at the end point and click to set the point.The completed, labeled distance measurement result appears in the AnnotationsPanel. If you position the cursor over the line, the length is shown over the center ofthe line.
Measurements and AnnotationsArea MeasurementsSt. Jude Medical7-6 Part Number ARTUS100109403Area MeasurementsYou can manually create a closed area trace of the lumen contour in the cross-sec-tion view. The area is calculated using Green’s Theorem, and is displayed in theframe in mm2 with the minimum and maximum diameter chords.NOTE: If the Automatic MLA and %DS option is enabled and you are reviewinga pullback recording, your system automatically adds a “Lumen Profile”measurement on each frame.NOTE: The minimum diameter chord has arrowheads that point inward (towardthe diameter chord). The maximum diameter chord has arrowheads thatpoint outward.Making a Manual Area Measurement1. Select the still image or paused recording that you want to measure.2. Click on the Area - Multiple Points button (Figure 7-1). The cursor changes to apen.3. Use the mouse to position the pen cursor at the desired starting point for the area inthe cross-section view and click to set the point.Figure 7-3: Manual Area Measurement (in progress)
Measurements and AnnotationsArea MeasurementsILUMIEN OPTIS SystemInstructions for Use 7-7NOTE: Click the Undo button to the left of the toolbar to delete themost recent point added to the image.4. Continue to add points with the pen cursor until you have accurately traced the areato be measured. You can place as many points as you like around the border of thedesired area. At least three points are required.NOTE: The first two points are connected by a straight line. When you placesubsequent points, the straight line becomes a smooth curve con-necting all points but not closing the area until you click the Acceptbutton, or the last point is sufficiently close to the initial point for thesystem to automatically complete the area. Placing more pointsincreases measurement accuracy.NOTE: You must click either Accept or Cancel to complete themeasurement. Click Cancel to completely erase the mea-surement.5. Click the Accept button to the left of the toolbar to save the measurement, or clickthe Cancel button to cancel it.
Measurements and AnnotationsAdding Text CalloutsSt. Jude Medical7-8 Part Number ARTUS100109403Adding Text CalloutsYou can add text callouts to a single frame or to the entire recording.Figure 7-4: Text Callouts
Measurements and AnnotationsAdding Text CalloutsILUMIEN OPTIS SystemInstructions for Use 7-9Adding Text Callouts1. Select the still image or paused recording that you want to annotate with text.2. Click on the Text... button (Figure 7-1). The cursor changes to a Text marker (“A”).3. Place the cursor where you want the text to be displayed.The Enter Note menu (see Figure 7-5) appears.4. Type the desired text into the box.5. If you want to display the text on all frames, click the Apply to all frames check-box. (Not applicable for text added in the L-Mode view.)6. Click OK to approve the note or click Cancel to cancel the note.The text appears, including a callout line beneath the text.7. To change the position of the text on screen, click and drag the text to the desiredposition.8. To change the position of the callout line, click the end of the line and drag it to thedesired position.Figure 7-5: Enter Note Dialog Box
Measurements and AnnotationsThe %AS CalculationSt. Jude Medical7-10 Part Number ARTUS100109403The %AS CalculationThe %AS (Percent Area Stenosis) calculation calculates the percentage size of asmaller area with relationship to a larger area, typically the area of the inner borderof a vessel compared to the area of the outer border.Formula for %AS Calculation%AS = (First Area-Second Area)/First Area * 100To make this calculation, you must have two areas drawn on the current frame.Make a %AS Calculation1. Make an area measurement.2. If necessary, make a second area measurement in the frame.3. Click on the %AS button (Figure 7-1) to display the Select Area Measurementdialog box.4. In the Outer Measurement list, click the larger area measurement.5. In the Inner Measurement list, click the smaller area measurement.6. Click OK.Figure 7-6: Select Area Measurement Dialog Box
Measurements and AnnotationsThe %AS CalculationILUMIEN OPTIS SystemInstructions for Use 7-11The % Area Stenosis calculation is displayed immediately below the previous cal-culations in the Annotation Panel as shown in Figure 7-7.NOTE: If the second measurement you select is larger than the first measure-ment, a %AS value will not be displayed. Instead, the AnnotationPanel displays an error message, similar to the one shown in Figure7-8.Figure 7-7: %AS CalculationFigure 7-8: %AS Error Message
Measurements and AnnotationsThe %DS CalculationSt. Jude Medical7-12 Part Number ARTUS100109403The %DS CalculationThe %DS (Percent Diameter Stenosis) calculation calculates the percentage size ofa smaller length with relationship to a larger one, typically the diameter of the innerborder of a vessel compared to the diameter of the outer border.Formula for %DS Calculation%DS = (First Length-Second Length)/First Length * 100To make this calculation you must first draw and specify two lengths, one for the smallerdiameter and one for the larger diameter.Make a %DS Calculation1. Make two length measurements in the current frame.2. Click on the %DS button (Figure 7-1) to display the Select Length Measurementdialog box.3. In the Outer Measurement list, click the longer length.4. In the Inner Measurement list, click the shorter length.5. Click OK.Figure 7-9: Select Length Measurement Dialog Box
Measurements and AnnotationsThe %DS CalculationILUMIEN OPTIS SystemInstructions for Use 7-13The % Diameter Stenosis calculation is displayed immediately below the previouscalculations in the Annotations Panel, as shown in Figure 7-10.NOTE: If the second measurement is larger than the first measurement you select,a %DS value will not be displayed. Instead, the Annotation Panel displaysan error message, similar to the one shown in Figure 7-8 for %AS.Figure 7-10: %DS Calculation
Measurements and AnnotationsField of ViewSt. Jude Medical7-14 Part Number ARTUS100109403Field of ViewYou can zoom out on a recording or still image in order to see the full lumen on a largevessel, centered on the catheter.NOTE: Using either Zoom function does not change the image data that is saved;it merely changes the portion of the data that is displayed.Increase/Decrease Field of ViewClick to increase the field of view on the recording or still image. Click again toreturn to normal image size.NOTE: Depending on the current Flush Medium, the image may not occupy theentire 10.5 mm diameter.You can change the magnification of the zoomed field. See “Adjust Playback Settings”on page 6-9 for more information.
Measurements and AnnotationsField of ViewILUMIEN OPTIS SystemInstructions for Use 7-15Zooming In ManuallyYou can enlarge any section of the image manually.NOTE: This magnification function cannot be used in the L-Mode display.1. Place the cursor over the image area you want to enlarge.2. Click and drag the mouse across an area to magnify it. When you release the mouse, the system zooms in to the selected rectangle, dis-playing the magnification factor used (ex. Zoom: 2.5x, see Figure 7-11). The system adds an overall view of the image to the right.3. To return to normal imaging, click anywhere in the zoomed image.Figure 7-11: Zooming an Image
Measurements and AnnotationsField of ViewSt. Jude Medical7-16 Part Number ARTUS100109403Quick ZoomThe Quick Zoom feature provides two pre-set levels of magnification bysimply clicking on the image with the left mouse button. Hover over thecross-sectional view so your cursor changes into a magnifying glass icon.Click once to zoom in to the first level; click a second time to zoom in to the second level;and then click again to return to normal magnification (1.0X).The pre-set Quick Zoom Factors can be customized in the Settings menu Displayoption. By default the First Click is set to 3.0X. The Second Click is set to 6.0X.Figure 7-12: Setup Menu, Display Option
Measurements and AnnotationsEditing Measurements and AnnotationsILUMIEN OPTIS SystemInstructions for Use 7-17Editing Measurements and AnnotationsAll measurements and annotations can be moved, deleted, or edited.• Area and length measurements can be adjusted by moving or deleting controlpoints.• Text annotations can be moved or deleted.NOTE: When a measurement is changed, calculations that depend on that mea-surement are updated automatically.
Measurements and AnnotationsEditing Measurements and AnnotationsSt. Jude Medical7-18 Part Number ARTUS100109403Moving Individual PointsTo move an individual point, click on the point and drag it to a new location.NOTE: When you select a point, the point changes from a circle to a square, indi-cating that it may now be moved.NOTE: If you move a point on an automatically-generated Lumen Profilecontour, an arrow icon appears in the corner of the measurementlisted in the Annotations Panel. Click the arrow to reset the contouron that frame back to the automatically-generated Lumen Profile contour.See “Lumen Profile Display Option” on page 7-20 for more information.Adding Points to a Multiple Point AreaTo add additional points to a multiple point area, click on the curve between two points.A new point will be added where you click.NOTE: When you position the mouse over a location where a point can be added,the cursor changes from an arrow to a hand.Deleting Points from a Multiple Point AreaTo delete selected points in a multiple point area, click on the desired point and press the<Del> key on the keyboard.NOTE: When you select a point, it changes from a circle to a square, indicatingthat it may now be deleted.
Measurements and AnnotationsEditing Measurements and AnnotationsILUMIEN OPTIS SystemInstructions for Use 7-19Deleting Individual Measurements or Text CalloutsNOTE: If a measurement is in use with a calculation (for example, an areaused by %AS), the individual measurement cannot be deleted untilthe calculation is deleted.To delete a measurement:• Click on the “x” next to it in the Annotations Panel. The measurement is deleted.To delete a distance measurement in the L-Mode:1. Click on a distance measurement in the L-Mode to select it. A white box appearsaround the label.2. Press the <Del> key on the keyboard. The distance measurement is deleted.To delete a text callout:1. Click on a text callout to select it. A white box appears around the text callout.2. Press the <Del> key on the keyboard. The text callout is deleted.Deleting All Measurements and Text CalloutsClick to delete all measurements, calculations, and text callouts from this recordingor still image.NOTE: Automatically generated Lumen Contours area measurements are notdeleted. If you have used the Lumen Profile function to calculate the min-imum lumen area, that measurement is not deleted.
Measurements and AnnotationsLumen Profile Display OptionSt. Jude Medical7-20 Part Number ARTUS100109403Lumen Profile Display OptionThe system automatically creates a trace of the lumen contour oneach frame. NOTE: Lumen Profile is not available with still images or station-ary recordings.L-Mode view must be turned on in order to use the Lumen Profiledisplay option. Remove the check from the Measurements checkbox to hide thelumen contour trace and corresponding measurements.The Lumen Profile display opens with Minimum Lumen Area (MLA) and a percent ste-nosis graph (%AS or %DS) turned on:•MLA displays the Minimum Lumen Area controls and values for this record-ing.•%DS shows how the mean diameter changes along the L-Mode. It can alsodisplay the %DS at MLA and proximal and distal reference points. •%AS shows how the lumen area changes along the L-Mode. It can also dis-play the %AS at MLA and proximal and distal reference points. NOTE: For information on displaying extended MLA info, see Table 10-12 onpage 10-21.
Measurements and AnnotationsLumen Profile Display OptionILUMIEN OPTIS SystemInstructions for Use 7-21Lumen Profile Display With MLA Controls OverviewCAUTION: It is the user’s responsibility to confirm the lumen contour on eachframe, and to make adjustments if necessary. Red frames indicate low confidence in the detected contour. If theMLA frame is in the vicinity of a low confidence region, the systemdisplays “?.??” for the MLA values. If the MLA values are “?.??,” thecontour on the MLA frame must be reviewed, edited if necessary, andaccepted before it can be displayed.Table 7-2: MLA ControlsADistal and Proximal Reference Frames : Move these to set the range for MLA calcula-tion. The system’s search for a minimum lumen area occurs on frames between the distal and proximal reference frames.See Table 7-3 on page 7-22 for more information on calculations. See Table 10-12 on page 10-21 for showing extended MLA info.• If %DS is selected in the Lumen Profile, the reference frames and the MLA frame dis-play the percent diameter stenosis at each end of the range.• If %AS is selected, the reference frames and the MLA frame display the percent area stenosis at each end of the range.BThe lumen area is colored black.CWhere the system has high confidence in the contour of the lumen area, or where the con-tour has been accepted by the user, the section is colored brown.DCalculated MLA : The dashed line indicates the position of the minimum lumen area between the distal and proximal reference frames (A).EWhere the system has low confidence in the contour of the lumen area, the section is col-ored red. These frames are not considered in the MLA search. If these frames are within the range where MLA is calculated, you must go to the MLA frame and confirm the con-tour.BCEA D A
Measurements and AnnotationsLumen Profile Display OptionSt. Jude Medical7-22 Part Number ARTUS100109403Table 7-3: Lumen Profile %AS and %DS CalculationsWhen Lumen Profile set to %DS... When Lumen Profile set to %AS...Stenosis calculations of the MLA frame compared to average of distal and proximal references (value listed above the MLA frame):%DS = 100 * (DREF - DMLA) / DREF where DREF is the average of the Distal Reference’s mean diameter and the Proximal Reference’s mean diameter. DMLA is the MLA’s mean diameter.%AS = 100 * (AREF - AMLA) / AREF where AREF is the average of the Distal Reference’s area and the Proximal Reference’s area. AMLA is the Minimum Lumen Area.Stenosis calculations of the MLA frame compared to individ-ual distal and proxi-mal references (values listed above the D or P reference frames):%DS = 100 * (DD or P - DMLA) / DD or P where DD or P is the Distal Reference’s mean diameter or the Proximal Reference’s mean diameter. DMLA is the MLA’s mean diameter.%AS = 100 * (AD or P - AMLA) / AD or P where AD or P is the Distal Reference’s area or the Proximal Reference’s area. AMLA is the Minimum Lumen Area.
Measurements and Annotations3D Display OptionILUMIEN OPTIS SystemInstructions for Use 7-233D Display OptionClick the Advanced Display button to create a 3D representation of the recording.Clicking the Advanced Display button toggles-through the options: Off, 3D Tissue, and3D Lumen. You can also select the desired option by clicking the button next to it.NOTE: You cannot add or change measurements or annotations in thecross-section view or 3D Display while 3D Display is on. You can addannotations and distance measurements to the L-Mode view only.3D Display is not available with still images or stationary recordings.
Measurements and Annotations3D Display OptionSt. Jude Medical7-24 Part Number ARTUS1001094033D Tissue Controls Table 7-4: 3D Tissue ControlsAView Mode : Click to toggle between Window mode (shown above) and Full Screen Mode.BCurrent Frame Indicator (3D View) : Scroll the mouse wheel (or twist the Navagation Con-troller) to change the cut plane as shown in the L-Mode.CCut Plane Rotation Hotspot : Place the cursor over the Hotspot and rotate the mouse wheel to change the cut plane as shown in the L-Mode.DCurrent Frame Indicator (L-Mode View) : Click and drag to change the frame shown.EThe solid lines in the cross-sectional view represent the rendered half of the vessel image. The dashed lines in the cross-sectional view represent the open, or un-rendered, half of the vessel image. The blue and yellow colors are for location referencing among the views.FClick and drag the divider bar side to side to change the size of 3D Display versus cross-section view.GCut Plane Indicator : The cut-plane is shown as a solid line in the cross-sectional view Click and drag this to change the lateral view shown in the L-Mode display.NOTE: To zoom you can either left click in the 3D Display window for Quick Zoom factors orright-click and drag up or down, left or right to adjust zoom.ACB3D Display Cross-Section View(TissueOptionShown)DFEG
Measurements and Annotations3D Display OptionILUMIEN OPTIS SystemInstructions for Use 7-253D Display with LumenNOTE: If the 3D Lumen setting is turned on, the 3D Tissue setting is turned off,and vice-versa. Selecting one deselects the other.The 3D Lumen setting adds a 3D representation of the lumen contours drawn on eachframe.NOTE: If you have the MLA setting turned on under the Lumen Profile displayand you have selected 3D Lumen (shown) or 3D Tissue, the distal, prox-imal, and MLA frames are displayed.Figure 7-13: 3D Display with LumenFigure 7-14: MLA Frames in 3DDistalProximalMLA
Measurements and Annotations3D Display OptionSt. Jude Medical7-26 Part Number ARTUS100109403Limitations of 3D DisplayPlease be aware of the following limitations of the 3D Display Option:• Although a vessel may curve, the 3D Display view always appears straight becauseof the limitations of reconstruction.• Artifacts caused by the relative motion of the catheter and the vessel often result ina saw-toothed appearance of the reconstruction and can lead to misinterpretation byinexperienced users.• Shortening or lengthening artifacts in the 3D Display reconstruction may occur dueto the relative motion of the imaging catheter with respect to the coronary arterycaused by the patient’s heart motion.
ILUMIEN OPTIS SystemInstructions for Use 8-1Exporting, Importing, and Managing Files 8CAUTION: Please note St. Jude Medical makes no representation or warrantythat use of the OPTIS INTEGRATED System complies with applicableprivacy, security and confidentiality laws, but encourages you toassess your own risk as you use, disclose, control, process or transferpatient health information with the OPTIS INTEGRATED System.
Exporting, Importing, and Managing FilesCompatible Transfer Media and USB DevicesSt. Jude Medical8-2 Part Number ARTUS100109403Compatible Transfer Media and USB DevicesThe following sections list the supported media formats. If you experience problems with a specific type of CD/DVD or USB device, contact St.Jude Medical for recommendations.Optical MediaThe system can export files through the CD/DVD drive. Table 8-1 lists the supported discformats and describes whether they can be erased and/or appended.If you try to export files to a CD-RW that already has data on it, an alert message appears.Click Yes to export your files to this disc, or click No to cancel the export.If you try to export files to a DVD+RW, DVD-RW, or DVD-RAM that already has dataon it, an alert message appears. Click OK to erase the disc and export your files, or clickCancel to cancel the export.If you try to export files to a disc that cannot be formatted or appended (such as DVD+RDL and DVD-R DL), an alert message appears. Insert a new disc to continue, or clickCancel to cancel the export.USB Connected MediaThe system can export files through the USB port. Any USB hard drive or Flash Drivethat meets the USB 2.0 Specification and is supported by Windows 7 SP1 may be used.WARNING: Inside the catheterization lab only port-powered USB drives may beconnected to the USB port. Connecting externally powered devices toTable 8-1: Optical Media CharacteristicsMedia Capacity Can Erase Can AppendCD-R 737 MB XCD-RW 737 MB X XDVD+R 4.7 GB XDVD+RW 4.7 GB XDVD+R Dual Layered 8.5 GB XDVD-R 4.7 GB XDVD-RW 4.7 GB XDVD-R Dual Layered 8.5 GBDVD-RAM 4.7 GB X
Exporting, Importing, and Managing FilesCompatible Transfer Media and USB DevicesILUMIEN OPTIS SystemInstructions for Use 8-3the USB port in the patient vicinity may compromise electrical isola-tion and cause patient injury.NOTE: Outside the catheterization lab, IEC 60950-compliant, externally poweredUSB hard drives may be connected to the USB port.
Exporting, Importing, and Managing FilesFile FormatsSt. Jude Medical8-4 Part Number ARTUS100109403File FormatsFiles can be exported in native file format (raw OCT format), a standard graphic file for-mat (standard format), or DICOM format. Exported files can be saved on a CD/ DVD orexternal USB device, or exported to a DICOM storage server. You can choose whether todelete files after transfer or keep them on the system.About Native (Raw OCT) FormatIf you export in native (raw OCT) file format, every feature of the OCT file will beexported, and the files can be imported into another ILUMIEN or OPTIS INTEGRATED Sys-tem or an Offline Review Workstation (ORW) and reviewed and manipulated there. Anexported OCT file contains exactly the same data as the original file, including any mea-surements and annotation additions, all patient information associated with each file, andsystem diagnostic information to help diagnose possible image quality problems.Note the following:• Native (raw OCT) files can be reviewed and manipulated only with an ILUMIENSystem, an OPTIS INTEGRATED System, or an ORW. They cannot be accessed withany other systems or software.• Native (raw OCT) files are large; exporting to CD/DVD may require many discs.About DICOM FormatFor a multiple-frame recording using DICOM format stored on a network server, themaximum resolution is 800 x 800.
Exporting, Importing, and Managing FilesFile FormatsILUMIEN OPTIS SystemInstructions for Use 8-5About Standard FormatIf you export in standard file formats (AVI, compressed AVI, or Multi-page TIFF forrecordings; JPEG, TIFF, or BMP for images), the images can be used in computer appli-cations outside the system, but cannot be imported into an ILUMIEN System, an OPTISINTEGRATED System, OPTIS MOBILE System, or an ORW. NOTE: For standard format multiple-file exports, the same limitations apply asdescribed in “Image Format and Size in Standard Formats”. Just as whenexporting a single file, you can choose the size and format.
Exporting, Importing, and Managing FilesImage Format and Size in Standard FormatsSt. Jude Medical8-6 Part Number ARTUS100109403Image Format and Size in Standard FormatsWhen exporting files in standard formats, the system gives you several choices of formatand file resolution (size). When making these choices, keep in mind the following:File Size• File size is dependent on resolution; the lower the resolution, the smaller the file.• Decreasing resolution makes the resulting image grainier, but no quantitativedata, annotations or measurements are lost.• Increasing resolution results in higher image quality in the exported file. Fora file that is a single frame (from a captured image, a paused image, or froma recording that has been edited down to only one frame), the maximum res-olution for export is 2048 x 2048.• For a multiple-frame recording, the maximum resolution is 1024 x 1024.• It is best to select the resolution that will actually be used in the intended applica-tion. When images are enlarged or reduced by the system, the maximum usefulinformation is preserved. External applications may not apply the same diligencewhen enlarging or reducing an image.Standard File Format• The system can export recordings as either AVI, compressed AVI, or Multi-pageTIFF format.• Most computers include standard players that will play AVI format files.• The Compressed AVI and Multi-page TIFF formats require that special play-ers for these formats be installed on the computer you will use to review thefiles.• The system can export still images as either JPEG, TIFF, or BMP.• TIFF and BMP files are high resolution bit-map files with large file size.• JPEG files are compressed image files designed especially for viewing in acomputer application. They are significantly smaller than TIFF or BMP files,and are typically the best choice for slide shows or other applications wherethe files will be viewed on a computer monitor.
Exporting, Importing, and Managing FilesExporting Files During a ReviewILUMIEN OPTIS SystemInstructions for Use 8-7Exporting Files During a ReviewDuring review, you can use the Export button to export the current recording or stillimage to Native (Raw) format, DICOM format, or standard file formats.NOTE: The Export button is unavailable while a recording is playing. To exportfrom a recording, pause the recording before clicking the Export button.All edits, including measurements, calculations, annotations and zoom, are included withthe recording or still image when it is exported (see Chapter 7 “Measurements and Anno-tations”).CAUTION: If you are exporting to standard formats, make all measurementsBEFORE exporting. Using non-OCT software to measure standardformat images will not produce accurate measurements.CAUTION: Do not use images that have been exported to JPEG or CompressedAVI formats for clinical decision making. These formats use compres-sion methods that may degrade the image quality.NOTE: Editing images stored on the system does not change the underlying imagedata in any way. All unedited data taken during the procedure is alwayspreserved and can be reviewed without the changes.NOTE: If the system displays an error message during export, a restart may berequired. If necessary, click OK to restart the system. If the error conditionpersists, export the recording from the Patient Summary menu, or reducethe resolution for the export of the recording. See “Exporting Files fromthe Patient Summary Menu” on page 8-14 for more information.Figure 8-1: Export Button (OCT)
Exporting, Importing, and Managing FilesExporting Files During a ReviewSt. Jude Medical8-8 Part Number ARTUS100109403Exporting Files in Native (Raw) Format1. Click the Export button.The Export Wizard opens (see Figure 8-2).2. Click to select Native (Raw), and click Next.3. If you need to remove patient identifying information from the exported files, adda check to the Anonymize checkbox.• If you have added a check to the Anonymize checkbox, you can also add analternate means of identifying the patient. Click the Alternate PIDs... buttonto open the Define Alternate Patient ID menu:• Click in the Alternate Patient ID column and type an alternate ID tagfor this patient.• Click the Auto-Generate button to add an alternate ID generated by thesystem. Click the Reset button to clear the ID generated by the system.Figure 8-2: The Export Wizard - Step 1Figure 8-3: Define Alternate Patient ID Menu
Exporting, Importing, and Managing FilesExporting Files During a ReviewILUMIEN OPTIS SystemInstructions for Use 8-9•Click OK to approve the change and close the menu, or Cancel toreturn to previous settings and close the Define Alternate Patient IDmenu.4. Click to set the System File Options for the file(s) that you are exporting:•Leave Unchanged - the files are exported, but the original files in the Systemare not changed.•Mark as Archived - the files are exported, and marked as archived.•Remove when Complete - the files are deleted from the System once theexport is complete.5. Click Next to approve the settings and open the next page of the Export Wizard.NOTE: Click Back to return to the previous page, or click Cancel to exit theExport Wizard without exporting files.6. Click to select an Export Destination:NOTE: If an output device is not available, that option cannot be selected.NOTE: Check that the Free space in the Drive Capacity section is largeenough to save the files that are being exported.•Click CD/DVD to export to a CD/DVD.If the inserted CD/DVD is blank, you can edit the name in the Volume Labelfield.•Click External Drive to export to an external USB device.If necessary, click the External Drive selection box to select the correct drivelocation from the drop-down menu.Click the Ellipsis (...) button to the right of the Path selection box to browsefor a specific folder on the device.7. Click Next to approve the settings and open the next page of the Export Wizard.The next page of the Export Wizard opens. The menu shows a summary of ExportInformation.8. Click Export to export the selected files.The export begins. If necessary, click Cancel to stop the export in progress.
Exporting, Importing, and Managing FilesExporting Files During a ReviewSt. Jude Medical8-10 Part Number ARTUS1001094039. When complete, click Done to close the Export Wizard.Exporting Files in DICOM Format1. Click the Export button.The Export Wizard opens (see Figure 8-2).2. Click to select DICOM, and click Next.NOTE: If you are reviewing a single frame instead of a recording, skip to Step 53. Click to select the material to be exported:•Pullback• Current Frame• Bookmarked Frames - This choice is unavailable if there are no book-marked frames in the recording.4. Click Next to approve the settings and open the next page of the Export Wizard.NOTE: Click Back to return to the previous page, or click Cancel to exit theExport Wizard without exporting files.5. If you need to remove patient identifying information from the exported files, adda check to the Anonymize checkbox.6. Click to set the System File Options for the file(s) that you are exporting:•Leave Unchanged - the files are exported, but the original files in the Systemare not changed.•Mark as Archived - the files are exported, and marked as archived.7. Click Next to approve the settings and open the next page of the Export Wizard.8. Click to select an Export Destination:NOTE: If an output device is not available, that option cannot be selected.NOTE: Check that the Free space in the Drive Capacity section is largeenough to save the files that are being exported.•Click CD/DVD to export to a CD/DVD.
Exporting, Importing, and Managing FilesExporting Files During a ReviewILUMIEN OPTIS SystemInstructions for Use 8-11If the inserted CD/DVD is blank, you can edit the name in the Volume Labelfield.•Click External Drive to export to an external USB device.If necessary, click the External Drive selection box to select the correct drivelocation from the drop-down menu.Click the Ellipsis (...) button to the right of the Path selection box to browsefor a specific folder on the device.•Click Remote Store to export to a network DICOM Server.NOTE: The Remote Store option is enabled only if the DICOM net-work connection has been configured on the DICOM tab ofthe Setup dialog box (see Chapter 10 “User Interface Refer-ence”for more information on DICOM settings).9. Click Next to approve the settings and open the next page of the Export Wizard.The next page of the Export Wizard opens, showing a summary of Export Infor-mation.10. Click Export to export the selected files.The export begins. If necessary, click Cancel to stop the export in progress. 11. When complete, click Done to close the Export Wizard.
Exporting, Importing, and Managing FilesExporting Files During a ReviewSt. Jude Medical8-12 Part Number ARTUS100109403Exporting Files in Standard FormatsNOTE: 3D reconstructions cannot be exported in Standard formats.1. Click the Export button.The Export Wizard opens (see Figure 8-2).2. Click to select Standard, and click Next.NOTE: If you are reviewing a single frame instead of a recording, skip to Step 5.3. Click to select the material to be exported:• Pullback• Current Frame• Bookmarked Frames - This choice is unavailable if there are no book-marked frames in the recording.4. Click Next to approve the settings and open the next page of the Export Wizard.NOTE: Click Back to return to the previous page, or click Cancel to exit theExport Wizard without exporting files.5. Click to set the resolution and file format.6. Click Next to approve the settings and open the next page of the Export Wizard.7. Verify the names of the files that are being exported. If necessary, double-click afilename and edit it using the keyboard.8. Click Next to approve the settings and open the next page of the Export Wizard.9. Click to select an Export Destination:NOTE: If an output device is not available, that option cannot be selected.NOTE: Check that the Free space in the Drive Capacity section is largeenough to save the files that are being exported.•Click CD/DVD to export to a CD/DVD.If the inserted CD/DVD is blank, you can edit the name in the Volume Labelfield.
Exporting, Importing, and Managing FilesExporting Files During a ReviewILUMIEN OPTIS SystemInstructions for Use 8-13•Click External Drive to export to an external USB device.If necessary, click the External Drive selection box to select the correct drivelocation from the drop-down menu.Click the Ellipsis (...) button to the right of the Path selection box to browsefor a specific folder on the device.10. Click Next to approve the settings and open the next page of the Export Wizard.The next page of the Export Wizard opens. The menu shows a summary of ExportInformation.11. Click Export to export the selected files.The export begins. If necessary, click Cancel to stop the export in progress. 12. When complete, click Done to close the Export Wizard.
Exporting, Importing, and Managing FilesExporting Files from the Patient Summary MenuSt. Jude Medical8-14 Part Number ARTUS100109403Exporting Files from the Patient Summary Menu You can export files from the Patient Summary menu.1. In the Patient Summary menu, add a check to the checkbox of each file that youwant to export.A white border appears around each record that is selected.NOTE: In the Patient Summary menu, you can select multiple files fromthe same date, but not from different dates. Within the Export Wiz-ard, you can select additional files from different dates and differentpatients.NOTE: To deselect a file, clear the check from the checkbox. The check andwhite border disappear to indicate that the file is no longer selected.2. Click the Export button at the top of the screen.The Export Wizard opens (see Figure 8-2).3. Click to select an export format, and click Next.The next page of the Export Wizard opens. Figure 8-4: Highlighted Records
Exporting, Importing, and Managing FilesExporting Files from the Patient Summary MenuILUMIEN OPTIS SystemInstructions for Use 8-154. To filter the list, click the All, Unarchived, or New since last archive button.5. If necessary, add a check to the checkbox of any other recording to be exported.• Add a check to the checkbox of patient to select all recordings for thatpatient.• Add a check to the checkbox of the first entry in the list to select allrecordings.6. Click Next to approve the list of files for export and open the next page of theExport Wizard.• If you are exporting in Native (Raw) format, refer to Step 3 in “ExportingFiles in Native (Raw) Format” on page 8-8 to continue the export.• If you are exporting in DICOM format, refer to Step 5 in “Exporting Files inDICOM Format” on page 8-10 to continue the export.• If you are exporting in standard formats, refer to Step 5 in “Exporting Files inStandard Formats” on page 8-12 to continue the export.
Exporting, Importing, and Managing FilesUsing Exported Standard Format RecordingsSt. Jude Medical8-16 Part Number ARTUS100109403Using Exported Standard Format RecordingsThe system can export recordings as either AVI, compressed AVI, or Multi-page TIFFformat. Most computers include standard players that will play AVI format files. How-ever, the Compressed AVI format and the Multi-page TIFF formats require that you havespecial players installed on your computer to review the files.St. Jude Medical DICOM ViewerWhen an image file is exported to a CD/DVD in the DICOM format, the St. Jude MedicalDICOM Viewer (shown in Figure 8-5) is also included on the CD/DVD. This DICOMCD/DVD can then be freely distributed and used with any Microsoft Windows computer(the CD/ DVD is configured to automatically launch the viewer when it is inserted intothe drive). The St. Jude Medical DICOM Viewer may only be used to view St. Jude Med-ical generated DICOM images on a St. Jude Medical DICOM CD/DVD. If this CD/DVDis to be used in a public forum, the Anonymous option should be used when exporting theimage using the system.Figure 8-5: St. Jude Medical DICOM Viewer - Image ViewViewer ControlsFile ViewerDirectory TreeImage View Selected
Exporting, Importing, and Managing FilesUsing Exported Standard Format RecordingsILUMIEN OPTIS SystemInstructions for Use 8-17The St. Jude Medical DICOM Viewer window contains three different sections:•Viewer Controls - Provides control over the viewer and the active image.•Directory Tree - This tree lists the patient, study, series, and image hierarchy con-tained in the DICOMDIR file on the CD/DVD. Individual images may be loaded byclicking on the image item in the tree.•File Viewer - Provides two tabs:•Image tab - Displays the image currently selected in the DICOM DirectoryTree (see Figure 8-5). If the image is a recording, playback may be controlledusing the playback buttons in the Viewer Controls at the top of the viewer.The image may also be zoomed in or out using the Zoom feature in the tool-bar.•Attributes tab - Displays a list of all DICOM modules and attributes con-tained in the currently selected image (see Figure 8-6).Figure 8-6: St. Jude Medical DICOM Viewer - Attributes ViewAttributes View Selected
Exporting, Importing, and Managing FilesUsing Exported Standard Format RecordingsSt. Jude Medical8-18 Part Number ARTUS100109403The St. Jude Medical DICOM files are compliant with the DICOM Standard (PS 3-2008)and use the Secondary Capture Multi-Frame Image Storage IOD (Information ObjectDefinition). The actual attributes contained in the file are listed in Table 8-2.Table 8-2: DICOM File AttributesModule AttributePatient Patient’s NamePatient IDPatient’s Birth DatePatient’s GenderGeneral Study Study Instance UIDStudy DateStudy TimeReferring Physician’s NameStudy IDAccession NumberPatient Study Patient’s AgeGeneral Series ModalitySeries Instance UIDSeries NumberSeries DateSeries TimeBody Part ExaminedGeneral Equipment ManufacturerInstitution NameManufacturer Model NameSoftware Version(s)General Image Instance NumberPatient OrientationContent DateContent TimeImage TypeAcquisition DateAcquisition TimeAcquisition DateTimeBurned In AnnotationImage Comments
Exporting, Importing, and Managing FilesUsing Exported Standard Format RecordingsILUMIEN OPTIS SystemInstructions for Use 8-19Lossy Image CompressionLossy Image Compression RatioImage Pixel Pixel DataSOP Common SOP Class UIDSOP Instance UIDInstance Creation DateInstance Creation TimeTimezone Offset from UTCInstance NumberMulti-frame1Frame Increment PointerRegion Calibration Sequence of RegionsCine1Frame TimeSC Equipment Conversion TypeModalitySC Device ManufacturerSC Device Model NameSC Device Software VersionSC Multi-frame Image1Burned In AnnotationFrame Increment Pointer1. Multi-frame files only.Table 8-2: DICOM File Attributes (continued)Module Attribute
Exporting, Importing, and Managing FilesImporting Files from a CD/DVD or USBSt. Jude Medical8-20 Part Number ARTUS100109403Importing Files from a CD/DVD or USB1. Connect an external database to the ILUMIEN OPTIS System:• Insert a CD/DVD containing a database into the system.• Connect an external hard drive to the system.2. In the Select Patient menu, click the Import button.The Select Database menu opens.3. Select the database to import, and click OK.4. The Import Database menu opens (Figure 8-7).Figure 8-7: Import Database MenuProgress Bar and Message Area
Exporting, Importing, and Managing FilesImporting Files from a CD/DVD or USBILUMIEN OPTIS SystemInstructions for Use 8-21An import may require installation of several CD/DVDs. When a new disc is required, thesystem ejects the current disc and displays a New Disc Request alert.Table 8-3: Import Database Menu OptionsSource Database List of files which will be imported. Each file is displayed in one row, and the patient name, patient ID, image creation date & time, comment, and status are displayed in columns. The list is initially sorted by ascending image creation date & time and can be sorted by any of the columns in ascending or descend-ing order by left-clicking once or twice on the desired column header.As each file is imported, its Status message is updated:•Importing - file is currently being imported.•On System - file has been copied to the system.•On Archive Media - file is on the current archive media and has not yet been imported.•Absent - file is not located on the current archive media•Failed - attempt to import the file failed.Select New Click to select only recordings that are not present in the ILUM-IEN OPTIS System.Progress Bar and Message Area The Progress Bar indicates the status of the file transfer. The Message Area displays information about the file and the transfer.Import Import the selected files.Cancel Cancel the import.
Exporting, Importing, and Managing FilesDeleting FilesSt. Jude Medical8-22 Part Number ARTUS100109403Deleting FilesYou can delete files by any of the following methods:• Exporting images with the Remove When Complete function turned on (see“Exporting Files in Native (Raw) Format” on page 8-8).• Select and delete files from the Patient Summary menu.• Select and delete files from the Database menu.CAUTION: Once files are deleted, they cannot be restored. After files have beendeleted, they can only be imported back to your system from yourarchived copies.Deleting Files from the Patient Summary Menu1. In the Patient Summary menu, add a check to the checkbox of each file that youwant to delete (see Figure 8-4 on page 8-14).A white border appears around each record that is selected.NOTE: In the Patient Summary menu, you can select multiple files fromthe same date, but not from different dates.NOTE: To deselect a file, clear the check from the checkbox. The check andwhite border disappear to indicate that the file is no longer selected.2. Click the Delete button at the bottom of the screen.A prompt asks you to confirm that you want to delete the selected files.3. Click Yes to delete the files, or click No to cancel the deletion and return to thePatient Summary menu.
Exporting, Importing, and Managing FilesDeleting FilesILUMIEN OPTIS SystemInstructions for Use 8-23Deleting Files from the Database Menu1. Click the Menu button and select Setup. The Setup dialog box opens.2. Click the Database button to open the Database menu (see Figure on page 10-7).3. Add a check to the checkbox of any recording to be deleted.• Add a check to the checkbox of patient to select all recordings for that patient.• Add a check to the checkbox of the first entry in the list to select all record-ings.4. Click the Delete button.A prompt asks you to confirm that you want to delete the selected files.5. Click Yes to delete the files, or click No to cancel the deletion and return to theDatabase menu.Figure 8-8: Deletion Warning Alert
Exporting, Importing, and Managing FilesTransfer and Import MessagesSt. Jude Medical8-24 Part Number ARTUS100109403Transfer and Import MessagesThe system displays a number of different messages to inform you of problems that mayarise during transfer and import operations.Table 8-4: Transfer MessagesError Message Cause ActionThe CD/DVD drive is empty. Please insert a writable CD/DVD, or click Cancel to stop the transfer.No CD/DVD is in the drive, though you have attempted to transfer files.To continue with the export, insert a blank CD/ DVD or a previously used CD/DVD on which there is sufficient space for the transfer. To stop the transfer, click Cancel.None of the selected files will fit on the disc. Please insert a different CD/DVD, or click Cancel to stop the transfer.Insufficient space is available on the destination CD/DVD and NONE of the selected files can be transferred to this disc.Insert a new writable CD/DVD into the drive and close the drive to transfer or click Cancel to stop the trans-fer and file deletion.Some files did not fit on the disc. Please insert another writable CD/DVD to con-tinue the transfer, or click Cancel to stop the transfer.Insufficient space is available on the destination CD/ DVD for all of the selected files, but SOME of the files have been transferred.To continue the transfer on the new disc, insert another writ-able CD/DVD into the drive and close the drive to continue the transfer. To interrupt the transfer, click Cancel. Some files may be on the first disc, some on the second. If you select Cancel, the CD/ DVD will contain the files previ-ously transferred, but the remainder will not be trans-ferred and the uncopied files will remain on the hard drive.Cancelling the transfer may damage the disc and render previously written files unreadable. Are you sure you want to cancel the transfer?You have attempted to inter-rupt a transfer in process by clicking Cancel.Click No to continue the transfer. Click Yes to stop the transfer and risk losing the files already transferred.An invalid volume name was specified. You have typed a character that cannot be used in a vol-ume name.Retype the name with accept-able characters.Transfer failed, the destination disk is full. The USB drive is full. Connect a different USB drive.
Exporting, Importing, and Managing FilesTransfer and Import MessagesILUMIEN OPTIS SystemInstructions for Use 8-25Transfer failed, the destination disc is not blank. The CD/DVD already con-tains files and cannot be appended.Insert a new writable CD/DVD into the drive and close the drive to transfer or click Cancel to stop the trans-fer.Transfer failed, the source or destination disk was removed. The USB drive is discon-nected. Reconnect the USB drive.Please insert the next CD to continue importing the data-base, or click Cancel to stop importing.The current disk is full and has been ejected. Insert another CD/DVD in the series or click Cancel to stop the import.Duplicate CD. Please insert the next CD to continue importing the database, or click Cancel to stop import-ing.You have inserted a CD/DVD containing files that have already been imported.Insert another CD/DVD in the series. or click Cancel to stop the import.Database not found. Please insert the next CD to continue importing the database, or click Cancel to stop import-ing.The currently inserted CD/DVD does not include a valid OCT database file.Insert a CD/DVD which con-tains a valid OCT database file (OCT.mdb or OCT.dbf) or click Cancel to stop the import.Incorrect database. Please insert the next CD to continue importing the database, or click Cancel to stop import-ing.The currently inserted CD/DVD includes a valid OCT database file, but is not in the same series as the previ-ously inserted CD/DVD(s).Insert a CD/DVD from the same series as the last CD/DVD or click Cancel to stop the import.Database import not com-plete. You have clicked Cancel, so the Import operation is not complete.Click OK to continue system operations. Some of the files may have been partially, but not fully copied into the sys-tem. If you try to open one of these files, the system will display an error message.Please insert the next CD to continue importing the data-base, or click Cancel to stop importing.Additional files exists on another disc. Insert the next disc. The mes-sage is automatically closed and import continues.Table 8-4: Transfer Messages (continued)Error Message Cause Action
Exporting, Importing, and Managing FilesDuplicate File Name MessagesSt. Jude Medical8-26 Part Number ARTUS100109403Duplicate File Name MessagesDuplicate file name messages warn you when a file has been selected for export with thesame name as one already saved. The system does not allow any files to be overwritten.NOTE: Do not save an image using the same name used for a previous file. St.Jude Medical recommends that you label media containing exported fileswith descriptive information, including the procedure or export date. Toresolve these errors when copying to CD/DVDs, insert another CD/DVDinto the drive and close the drive. File transfer resumes automatically. Ifthe transfer is cancelled, the uncopied files will remain on the hard drive.Database StatisticsYou can check the size and statistics of your system’s database using the Database Main-tenance button in the Setup dialog box. See “Setup - Database/Maintenance Menu” onpage 10-9 for more information.Table 8-5: Duplicate File Name MessagesMessage Cause ActionDuplicate files could not be written. Please insert a differ-ent CD/DVD to continue the transfer, or click Cancel to stop the transferSOME of the file names in an export set are already found on the installed CD/DVD.Files with non-identical names will be written to the current CD/DVD; files with identical names will not be written. To save the files with the duplicate file names, insert a new CD/DVD and continue with the transfer. To stop the transfer, click Cancel.The disc already contains files with the same names. Please insert a different CD/DVD to continue the transfer, or click Cancel to stop the transfer.ALL the file names in an export set are already found on the installed CD/DVD.To save these files with these file names, insert a new CD/DVD and continue with the transfer. To stop the trans-fer, click Cancel. This mes-sage may be displayed when the Delete after transfer checkbox in the Manage Exported Files menu is unchecked, leading to re-exporting the same files.
Exporting, Importing, and Managing FilesDatabase StatisticsILUMIEN OPTIS SystemInstructions for Use 8-27Importing Patient Information From a DICOM Worklist or Storage Server From DICOM WorklistTo import patient information From a DICOM Worklist, complete the following steps: 1. From the Select Patient menu, click the Add Patient button. The Add Patient -Step 1 guidance displays.2. Select DICOM Worklist Items. Click the Next button. The Add Patient - Step 2guidance displays.Figure 8-9: Add Patient - Step 1 (Worklist)
Exporting, Importing, and Managing FilesDatabase StatisticsSt. Jude Medical8-28 Part Number ARTUS1001094033. Enter a valid date range to search, or un-check Scheduled Procedure Step StartDate and enter any other valid search term. Click Next. The Add Patient - Step 3guidance displays.4. Select the patient by clicking on the name. The New OCT Recording button andthe New FFR Recording button become active.Figure 8-10: Add Patient - Step 2
Exporting, Importing, and Managing FilesDatabase StatisticsILUMIEN OPTIS SystemInstructions for Use 8-295. Click either the New OCT Recording button or the New FFR Recording buttonto continue.From a DICOM Storage ServerTo import patient information From a DICOM Storage Server, complete the followingsteps: 1. From the Select Patient menu, click the Add Patient button. The Add Patient -Step 1 guidance displays.
Exporting, Importing, and Managing FilesDatabase StatisticsSt. Jude Medical8-30 Part Number ARTUS1001094032. Select DICOM Patient Info. Click the Next button. The Add Patient - Step 2guidance displays.3. If there is more than one DICOM Storage Server detected, select the desired server.Click the Next button. The Add Patient - Step 3 guidance displays.Figure 8-11: Add Patient - Step 1 (Storage Server)
Exporting, Importing, and Managing FilesDatabase StatisticsILUMIEN OPTIS SystemInstructions for Use 8-314. Enter a search term such as the Patient Name (shown), Patient ID, or leave blankto return the entire list of Patients. Click the Search button. The results display.5. Click to highlight the patient, then click the New OCT Recording button or NewFFR Recording button. The patient data is entered.
Exporting, Importing, and Managing FilesDatabase StatisticsSt. Jude Medical8-32 Part Number ARTUS100109403
ILUMIEN OPTIS SystemInstructions for Use 9-1Cleaning & Maintenance 9CAUTION: Only a qualified service representative can service components of thesystem. Any attempt to open the system components by anyone otherthan a qualified St. Jude Medical service representative will void thewarranty.CAUTION: Do not perform cleaning or maintenance on the system in the patientenvironment.
Cleaning & MaintenanceContacting St. Jude Medical ServiceSt. Jude Medical9-2 Part Number ARTUS100109403Contacting St. Jude Medical ServiceService can be contacted at:E-mail: OCTservice@sjm.comPhone: +1 855 478 5833 US Toll-free +1 651 756 5833 InternationalCleaningCleaning of the ILUMIEN OPTIS System consists of:• Cleaning system surfaces.• Cleaning the DOC and its cable.
Cleaning & MaintenanceCleaningILUMIEN OPTIS SystemInstructions for Use 9-3Routine Cleaning ProcedureThe OPTIS Integrated DOC, DOC Holster, and Table Side Controller should be cleanedfollowing the facilities standard cleaning schedule, or at least every 30 days under normaluse.1. Turn off all system components with accessible power controls and unplug thepower cables.2. Clean system surfaces and the keyboard with a dry cloth, or a dry cloth slightlydampened with water.3. Clean the monitor’s LCD surface with a lint-free, non-abrasive cloth.CAUTION: DO NOT clean the LCD surface with detergents or other clean-ing solutions.4. Clean exposed system cables with a soft cloth moistened with water or a mild deter-gent.5. Clean the DOC and the DOC optical cable with a disinfectant wipe or CidexTM1(Glutaraldehyde 3.4%) and a soft cloth. Be particularly careful not to stress orsharply bend the DOC optical cable.NOTE: Though enclosed in a bag during use, the DOC is the system compo-nent most exposed to dirt, fluids, and debris.NOTE: The Table Side Controller is not water-proof. Be careful to not useexcessive moisture when cleaning this device.6. Clean all other exposed system cables with a soft cloth moistened with water orwater and a mild detergent.1. Cidex is a trademark of Johnson & Johnson Corporation.
Cleaning & MaintenanceMaintenanceSt. Jude Medical9-4 Part Number ARTUS100109403MaintenanceMaintenance of the system consists of:• Cleaning the optical connection in the DOC and the Dragonfly™ Imaging Catheter.• Replacing the optical adapter in the DOC.• Inspecting exposed cable connections.• Transferring log files.• Identifying the installed software version.
Cleaning & MaintenanceMaintenanceILUMIEN OPTIS SystemInstructions for Use 9-5Optical Connection Cleaning ProcedureThe optical connection between the DOC and the Dragonfly™ Imaging Catheter shouldbe cleaned whenever there is a loss of image quality. Image quality should also bechecked every 3 months, and the connection cleaned if there is a loss of quality.CAUTION: This procedure should not be performed during a patient case on asterile catheter.NOTE: Before beginning this procedure ensure that you have the St. Jude MedicalOptical Fiber Connector Cleaner available.NOTE: Do not touch any of the optical connectors or the end of the Optical FiberConnector Cleaner as this may damage them.1. If a catheter is connected to the DOC, press the Unload button on the DOC and waituntil the “lock” LED stops flashing. Once the “lock” LED is off, remove the cathe-ter.2. Click the Menu button and select the Setup option. The Setup dialog box displays. 3. Click the Service button. The Service menu displays.4. In the DOC Service section of the Service menu, click the Enter button.The DOC optical carriage moves all the way to the front and then locks into posi-tion for 1 minute. Rotation of the DOC rotary motor is stopped and the laser sourceis turned off.5. Remove the sizing cap from the end of the Optical Fiber Connector Cleaner (seeFigure 9-1).6. Insert the cleaner into the center of the Optical Adapter in the DOC, ensuring itseats fully, and press until it clicks.
Cleaning & MaintenanceMaintenanceSt. Jude Medical9-6 Part Number ARTUS100109403The cleaning material in the Optical Fiber Connector Cleaner is moved over theoptical connection cleaning it.7. Remove the cleaner from the DOC.8. In the DOC Service section of the Service menu, click the Exit button.The DOC optical carriage moves all the way to the back and all DOC functions arereturned to their normal state.9. Click on OK or Cancel to close the Setup dialog box.10. Open the sizing cap and place it on the end of the Optical Fiber Connector Cleaner(see Figure 9-2).11. Insert the cleaner into the optical connection in the Dragonfly Imaging Catheter,ensuring it seats fully, and press until it clicks.The cleaning material in the Optical Fiber Connector Cleaner is moved over theoptical connection cleaning it.Figure 9-1: Inserting Cleaner Into Optical Adapter
Cleaning & MaintenanceMaintenanceILUMIEN OPTIS SystemInstructions for Use 9-712. Remove the cleaner from the Dragonfly.13. Reconnect the Dragonfly Imaging Catheter to the DOC.14. Return the system to normal operation.Figure 9-2: Inserting Cleaner Into Catheter
Cleaning & MaintenanceMaintenanceSt. Jude Medical9-8 Part Number ARTUS100109403Optical Adapter Replacement ProcedureThe Optical Adapter should be replaced every 200 cycles or 1 year (which ever comesfirst), or if cleaning (see “Optical Connection Cleaning Procedure”) does not improve theimage quality.CAUTION: This procedure should not be performed during a patient case.NOTE: Before beginning this procedure ensure that you have a replacement St.Jude Medical Optical Adapter and pliers supplied with it available.NOTE: Do not touch any of the optical connectors as this may damage them.1. If a catheter is connected to the DOC, press the Unload button on the DOC and waituntil the “lock” LED stops flashing. Once the “lock” LED is off, remove the cathe-ter.2. Click the Menu button and select the Setup option. The Setup dialog box displays. 3. Click the Service button. The Service menu displays.4. In the DOC Service section of the Service menu, click the Enter button.5. Click on the Enter DOC Service button.The DOC optical carriage moves all the way to the front and then locks into posi-tion for 1 minute. Rotation of the DOC rotary motor is stopped and the laser sourceis turned off.6. Use pliers to grip either short surface of the adapter as shown (see Figure 9-3).Ensure the pliers seat over the lip on the end of the adapter.Figure 9-3: Proper Gripping of Adapter for Removal
Cleaning & MaintenanceMaintenanceILUMIEN OPTIS SystemInstructions for Use 9-97. Pull the adapter straight out of the DOC.NOTE: Ensure that the adapter does not rotate while it is being removed asthis could damage the DOC or break the adapter.8. Remove the cap and plug from the replacement Optical Adapter.NOTE: Do not touch any of the optical connectors as this may damage them.9. Using your fingers, align the new adapter with the DOC, ensuring the key is alignedwith the slot in the optical carriage, and firmly press it into place.There is a small click when the adapter seats.NOTE: If the carriage moves when you press on the adapter, click the Exitbutton in the DOC Service section of the Service menu. Once itchanges to Enter, click it again. Once the optical carriage is lockedinto position at the front of the DOC firmly press the adapter intoplace.10. In the DOC Service section of the Service menu, click the Exit button.The DOC optical carriage moves all the way to the back and restores all DOC func-tions to their normal state.11. Click on OK or Cancel to close the Setup dialog box.12. Return the system to normal operation.Figure 9-4: Alignment of Optical Adapter with Optical CarriageOptical CarriageKey Slot
Cleaning & MaintenanceMaintenanceSt. Jude Medical9-10 Part Number ARTUS100109403Cable Connection Inspection Procedure1. Make sure the power cords are in good condition and are properly plugged in.2. If a secondary ground connection is being used, ensure that both ends of the cableare secure.3. Ensure all other connectors are fully seated and properly secured.
Cleaning & MaintenanceMaintenanceILUMIEN OPTIS SystemInstructions for Use 9-11Transferring Log FilesLog files may be transferred to a CD or external USB device so that you can archive themor E-mail them to St. Jude Medical Service.NOTE: When there are multiple repeated events of the same type the event logsare condensed into two messages. The first message logs the initial event,and the second message logs the event along with a repeat count.1. Click the Menu button and select the Setup option. The Setup dialog box displays. 2. Click the Service button. The Service menu displays.3. In the Service Log area, click the Export button.Figure 9-5: Transfer Event Log Files Menu
Cleaning & MaintenanceMaintenanceSt. Jude Medical9-12 Part Number ARTUS100109403The Transfer Event Log Files menu opens (Figure 9-5), which lists all the files tobe exported.4. Click to select a Transfer Destination:NOTE: If an output device is not available, that option cannot be selected.NOTE: Check that the Free space in the Drive Capacity section is largeenough to save the files that are being exported.•Click CD/DVD to export to a CD/DVD.If the inserted CD/DVD is blank, you can edit the name in the Volume Labelfield.•Click External Drive to export to an external USB device.If necessary, click the External Drive selection box to select the correct drivelocation from the drop-down menu.Click the Ellipsis (...) button to the right of the Path selection box to browsefor a specific folder on the device.5. Click the Transfer button to transfer the files or Cancel to cancel the operation.
Cleaning & MaintenanceInfection ControlILUMIEN OPTIS SystemInstructions for Use 9-13Identifying the Software VersionThe Startup window (Figure 9-6) shows the version and copyright information for thesystem. If the system is running, type <Ctrl-S> to open the Startup window. The softwareversion information might be required when contacting St. Jude Medical Service.Infection ControlFollow the infection control procedures established in your institution for protection ofboth staff and patient.Blood on system components, panels, and cables should be removed by using a gauze padwith soap and water, and drying with a soft cloth to prevent corrosion. The DOC cable canbe cleaned with a disinfectant wipe or Cidex and a soft cloth.Figure 9-6: System Startup WindowSoftware version and copyright information
Cleaning & MaintenanceUser TroubleshootingSt. Jude Medical9-14 Part Number ARTUS100109403User TroubleshootingTable 9-1 provides basic guidelines for troubleshooting the ILUMIEN OPTIS System.“Troubleshooting OCT Acquisition” on page 5-19 explains what to do if a catheter failsduring pullback.If your problem is not resolved after attempting the suggested remedies, contact your ser-vice representative or E-mail OCTservice@sjm.com.Table 9-1: User Troubleshooting TipsSymptom Possible Causes RemedyGeneralScreen blank, power indicator on moni-tor not lit.Display not turned on. Press the power button on the monitor to turn on monitor power.Display power cord unplugged. Plug the monitor power cord into the back of monitor.System power not turned on. Turn on the system power with the main power switch, located next to the power cord connection.System power cord not plugged in or not tight at either system end or wall connection.Check to make sure plug is tightly con-nected to both the system and to the wall outlet.Main system power fuse is blown. Refer to the Electrical label on the system (located next to the power cord connection) for fuse information. Contact your service representative for instructions.Outlet power disrupted. Check voltage at the wall outlet.Screen blank, power indicator on moni-tor lit.PC auto-boot failed. Turn off the main power switch and wait fifteen seconds. Turn the main power switch back on, and press the On/Standby button on the right side of the keyboard to start the system. If the system still does not start, contact your St. Jude Medical service representative for instructions.Monitor not enabled. Click <Alt+C> on the keyboard to enable the display. If the screen remains blank, turn off the main power switch and wait fif-teen seconds. Turn the main power switch back on, and press the On/Standby button on the right side of the keyboard to start the system.
Cleaning & MaintenanceUser TroubleshootingILUMIEN OPTIS SystemInstructions for Use 9-15ConnectionsDuring data export, the system does not list the USB drive plugged into the USB port.The connected USB drive is not compatible with the system, or the USB drive requires for-matting.Connect only a USB Drive supported by Windows 7 SP1. Refer to the instructions for use that came with your USB drive to determine if formatting is required.Screen message “Imaging engine ini-tialization failed” is displayed at startup.This message can be caused by several prob-lems, including loose or damaged system con-nections.Shut down the system, turn off the main system power, and wait 15 seconds. Then turn the system back on. If the error is dis-played again, note the error code displayed (if any) then contact your St. Jude Medical service representative for instructions.DOCOptical fiber does not rotate when Live View is pressed.The Stop button on the DOC was pressed. Check screen for message and follow instructions.Imaging catheter defec-tive, optical fiber does not rotate.Replace imaging catheter.DOC makes exces-sive noise without imaging catheter connected.DOC mechanism fail-ure. Contact your service representative to obtain a replacement DOC.ImagingOCT image dim, with no background noise visible.Monitor contrast and brightness set incor-rectly.Set monitor contrast and brightness using monitor controls on the monitor.Image contrast levels set incorrectly. Check the Presentation Settings on the Settings tab of the OCT Settings menu (normal settings are: Black level = 5%, White level = 90%. With the optical fiber rotating (scanning mode), reduce the Black level until background noise just becomes visible. Lack of background noise during optical fiber rotation indicates a defective imaging engine. See other possible causes and remedies below.Defective imaging cath-eter causing system sat-uration.Remove imaging catheter from DOC. If background noise appears, the imaging catheter is defective. Replace catheter.Table 9-1: User Troubleshooting Tips (continued)Symptom Possible Causes Remedy
Cleaning & MaintenanceUser TroubleshootingSt. Jude Medical9-16 Part Number ARTUS100109403Dirty connection between DOC and imaging catheter.Refer to “Optical Connection Cleaning Procedure” on page 9-5 to clean the con-nection.Table 9-1: User Troubleshooting Tips (continued)Symptom Possible Causes Remedy
Cleaning & MaintenanceSystem DisposalILUMIEN OPTIS SystemInstructions for Use 9-17System DisposalDisposal of the equipment must be in accordance with local laws.
Cleaning & MaintenanceSystem DisposalSt. Jude Medical9-18 Part Number ARTUS100109403
ILUMIEN OPTIS SystemInstructions for Use 10-1User Interface Reference 10Setup Dialog Box and SubmenusThe Setup dialog box provides access to all of the configuration and service functions forthe system. The Setup dialog box is accessed by selecting the Setup option from theMenu button options on the Select Patient or Patient Summary screen. NOTE: When creating or reviewing an OCT recording, the Settings button opensa context-sensitive OCT Settings menu. When creating an FFR recording,the Settings button opens the FFR Settings menu.All menus within the Setup dialog box share the following common buttons located at thebottom of the dialog box.Table 10-1: Setup Dialog Box Common OptionsRefresh Click to update the values displayed in the current tab.OK Click to approve any changes and close the Setup dialog box.Cancel Click to cancel any changes and close the Setup dialog box.Apply Click to approve any changes and keep the Setup dialog box open.
User Interface ReferenceSetup - Acquisition MenuSt. Jude Medical10-2 Part Number ARTUS100109403Setup - Acquisition MenuTable 10-2: Setup - Acquisition Menu Settings Recording TypeSets the recording type for image acquisition:Pullback - Performs a recording while the imaging core of the catheter is pulled back within the cathe-ter sheath.Stationary - The system records the live view image for 6 seconds without pulling the imaging core of the catheter back.Automatically review recordings Turns on and off automatic review after recording real-time images.Figure 10-1: Setup - Acquisition Menu
User Interface ReferenceSetup - Acquisition MenuILUMIEN OPTIS SystemInstructions for Use 10-3Trigger TypeSets the Pullback trigger type to use for image acquisition:Automatic - The system automatically begins a recording when it detects that the vessel has been cleared by the flush injection.Manual - The System does not perform a pullback until you click the Start Pullback button on the screen, or press the Enable button on the DOC.Pullback SpeedSets the pullback speed.NOTE: When connected to an original C7 Drag-onfly imaging catheter, the PullbackSpeed settings are limited to 10.0mm/sec, 20.0 mm/sec, and 25.0 mm/sec.For Dragonfly Duo or OPTIS, availablespeeds are 18 and 36 mm/sec.Pullback LengthSets the length of the pullback.NOTE: When connected to an original C7 Drag-onfly imaging catheter, the PullbackLength setting is limited to 54 mm. ForDragonfly Duo or OPTIS PullbackLength is 54 mm when speed is 18mm/sec and 75 mm when speed is 36mm/sec.Imaging Catheter TypeNOTE: This displays the type of catheter when acatheter has been connected.NOTE: Only Dragonfly imaging catheters areapproved for use with the ILUMIEN OPTISSystem for cardiovascular imaging.Guided Workflow Turns on and off the appearance of the purge cathe-ter guidance message.Table 10-2: Setup - Acquisition Menu Settings (continued)
User Interface ReferenceSetup - Acquisition/Other MenuSt. Jude Medical10-4 Part Number ARTUS100109403Setup - Acquisition/Other MenuTable 10-3: Setup - Acquisition/Other Menu SettingsFlush MediumControls the contrast options available in the Flush Medium drop-down box.Checked - Only 100% contrast is available, and the Flush Medium drop-down box under Settings is unavailable.Unchecked - All configured contrast options are available for selection in the Flush Medium drop-down box.NOTE: To change the Flush Medium settingbefore performing an OCT recording, see“Confirm Recording Settings” on page5-12.Acquisition Mode This option should remain unchecked unless instructed otherwise by SJM personnel.Figure 10-2: Setup - Acquisition/Other Menu
User Interface ReferenceSetup - Administration MenuILUMIEN OPTIS SystemInstructions for Use 10-5Setup - Administration MenuTable 10-4: Setup - Administration Menu SettingsInstitution Name Click here and enter or clear the institution name.Date and Time Opens the system Date and Time Properties menu.Default SettingsResets all user-entered configuration values except the date and time to the original factory default values.CAUTION: Restoring factory default settings resetsALL user-entered configuration valuesexcept the date and time. This buttonshould be used only by qualified servicepersonnel or under their direction.Figure 10-3: Setup - Administration Menu
User Interface ReferenceSetup - Administration MenuSt. Jude Medical10-6 Part Number ARTUS100109403System Information Displays current date, system name, institution name, and software versionEnd User License AgreementDisplays EULA.Resets EULA. The EULA must be accepted upon first operation after reset in order to access the system.Table 10-4: Setup - Administration Menu Settings (continued)
User Interface ReferenceSetup - Database MenuILUMIEN OPTIS SystemInstructions for Use 10-7Setup - Database MenuThe Database menu in the Setup dialog box shows a list of all files in the database. Fromthis menu, you can select patients or individual recordings for export, delete recordings,or select a patient for editing.Click on individual recordings to select them, or click on a patient’s name to select all recordingsfor that patient, or click on the database to select all recordings.Table 10-5: Setup - Database Menu SettingsDatabase display The database display shows all recordings, grouped by patient name, and then by the date of the recordings.Export Exports the selected recordings.Delete Deletes the selected recordings.Figure 10-4: Setup - Database Menu
User Interface ReferenceSetup - Database MenuSt. Jude Medical10-8 Part Number ARTUS100109403Edit Patient... Click on a patient’s name to edit the patient’s information. See “Edit-ing Patient Information” on page 3-8 for more information.Anonymize... Click on a patient’s name to remove the patient’s identifying informa-tion from the record. See “Exporting Files in Native (Raw) Format”, Step 3, on page 8-8, for an explanation of the anonymization function.Table 10-5: Setup - Database Menu Settings (continued)
User Interface ReferenceSetup - Database/Maintenance MenuILUMIEN OPTIS SystemInstructions for Use 10-9Setup - Database/Maintenance MenuYou can check the status of the system’s OCT database using the Database Maintenancemenu in the Setup dialog box. From this menu, you can check the size of the databasefile, as well as the number of files referenced by the database and the combined size ofthese files. This menu also warns you of possible issues found with files in the system’sdatabase.Table 10-6: Setup - Database/Maintenance Menu SettingsDisk Usage Provides both a graphic and text showing the amount of free and used space on the system’s hard disk.Figure 10-5: Setup - Database/Maintenance Menu
User Interface ReferenceSetup - Database/Maintenance MenuSt. Jude Medical10-10 Part Number ARTUS100109403Database File Indicates the size of the database file.Missing ImagesOCT image files that are referenced by the data-base but could not be found. Click the Clean but-ton to remove references to files that cannot be found.Missing and Low Resolution ThumbnailsThumbnail image files that are missing or are low resolution. Click the Generate button to generate new thumbnail image files.Orphaned ImagesOCT image files that were found on the system but are not referenced by the database. Click the Delete button to delete these orphaned files to free up additional hard disk space.Table 10-6: Setup - Database/Maintenance Menu Settings (continued)
User Interface ReferenceSetup - Database/Physician MenuILUMIEN OPTIS SystemInstructions for Use 10-11Setup - Database/Physician MenuTable 10-7: Setup - Database/Physician SettingsPhysician list Shows a list of all physician names entered in the system.• Click Add to add a new physician name.• Click a name and click Delete to remove the name.Figure 10-6: Setup - Database/Physician Menu
User Interface ReferenceSetup - DICOM MenuSt. Jude Medical10-12 Part Number ARTUS100109403Setup - DICOM MenuThe DICOM menus in the Setup dialog box are used to configure the network settings ofthe system and the Remote DICOM Server so that the system can initiate a network con-nection between the two systems. If multiple network adapters exist on the system (not aSt. Jude Medical standard configuration) only the primary network adapter can be used.CAUTION: The ILUMIEN OPTIS System should only be connected to a secureintranet. Direct connection to the Internet may interfere with correctoperation and/or result in inappropriate access to patient information,and voids system warranties. Please note St. Jude Medical makes no representation or warrantythat use of the ILUMIEN OPTIS System complies with applicable pri-vacy, security and confidentiality laws, but encourages you to assessyour own risk as you use, disclose, control, process or transfer patienthealth information with the system.
User Interface ReferenceSetup - DICOM MenuILUMIEN OPTIS SystemInstructions for Use 10-13It is strongly recommended you contact your IT department to set up the system on theDICOM server. Refer to the St. Jude Medical DICOM Conformance Statement for moreinformation on configuration.Table 10-8: Setup - DICOM Menu SettingsServer Nickname Displays the Nickname for the server.Server Type Displays the type of DICOM server; either PACS or Modal-ity Worklist (MWL)Add Click to Add a server.Delete Click to Delete a server.Edit Click Edit to display the Configure DICOM menu.Test Connection Click to send a Test signal to the server and confirm that you have successful communication.Figure 10-7: Setup - DICOM Menu
User Interface ReferenceSetup - DICOM MenuSt. Jude Medical10-14 Part Number ARTUS100109403Figure 10-8: Configure DICOM Menu
User Interface ReferenceSetup - DICOM MenuILUMIEN OPTIS SystemInstructions for Use 10-15Table 10-9: Setup - Configure DICOM Menu SettingsHostname The host name of the network server that contains the Remote DICOM Server. Use this option to identify the server if the network supports the Domain Name System (DNS) and the host name is known; otherwise, use Specify IP Address (see below).Network Timeout (secs) The maximum time to allow for a network ping response from the network server that contains the Remote DICOM Server. The minimum setting is 1 second while the maxi-mum is 120 seconds. The default is 15 seconds.Specify IP Address The IP address of the network server that contains the Remote DICOM server. If the Remote Hostname is used to identify the server, this field will be automatically filled in if the Ping Host button (Figure 10-8) is successfully used to verify the network connection. Check the Specify checkbox to the right of this option to explicitly specify the remote IP address.Ping Host This button can be used to test the network connection between the System and the Remote DICOM Server Host. If Hostname or IP address is not correct, a Ping Failed error message displays. Local AE Title The AE (Application Entity) title used to identify the Local DICOM Store SCU (Service Class User) used by the ILUM-IEN OPTIS System.Remote AE Title The AE title used to identify the Remote DICOM Server SCP (Service Class Provider) to which the system connects.Remote Port The port number on which the Remote DICOM Server Host will be listening for connection requests. The default is 104.Remote Nickname The nickname of the remove server defined by the user (16 characters maximum).Query Server Click to send a request from the system to the remote server to query the presentation context supported by the remote server. A test connection request is also sent from the server along with the query.
User Interface ReferenceSetup - DICOM MenuSt. Jude Medical10-16 Part Number ARTUS100109403Response Timeout (secs) The maximum time to allow for a response from the Remote DICOM Server after sending a DICOM request. The mini-mum setting is 15 seconds while the maximum is 1800. The default is 600 seconds. Press the Test Connection button to test the connection between the Local DICOM Store SCU and the Remote DICOM Server SCP. For a successful test:• A TCP/IP connection is successfully made from the sys-tem to the remote server using the server IP address and port.• A DICOM Associate Connection between the Local SCU and the Remote SCP is accepted by the SCP.• A C-Echo request (Verification class) from the Local SCU results in a successful response from the Remote SCP.NOTE: If the DICOM server does not support Multi-FrameTrue Color Secondary Capture, a warning messageappears, telling you to use SC-Image-Storage SOPclass instead. If the DICOM server supports neitherthe Multi-Frame True Color Secondary Capture norSecondary Capture, a warning message appears:"The presentation syntax supported by the remoteserver is not compatible. Images cannot beexported to the remote DICOM server."NOTE: The Test Connection button is unavailable if theObtain an IP Address Automatically checkbox ischecked. See “Setup - DICOM/Local Host Menu”on page 10-19.Table 10-9: Setup - Configure DICOM Menu Settings (continued)
User Interface ReferenceSetup - DICOM/Image Options MenuILUMIEN OPTIS SystemInstructions for Use 10-17Setup - DICOM/Image Options MenuTable 10-10: Setup - DICOM/Image Options Menu SettingsSOP ClassSC-Multi-Frame-True- Color-Image-Storage SOP: When this button is selected, DICOM images are exported as Multi-Frame True Color Secondary Capture. This selection is checked by default.SC-Image-Storage SOP: When this button is selected, DICOM images are exported as Sin-gle-Frame Secondary Capture.Ultrasound-Multi-Frame-Image-Storage SOP: When this button is selected, the images are exported as Ultrasound Multi-Frame DICOM data sets.Figure 10-9: Setup - DICOM/Image Options Menu
User Interface ReferenceSetup - DICOM/Image Options MenuSt. Jude Medical10-18 Part Number ARTUS100109403Modality Check to select the image modality: OCT, OT (Other), or US (Ultrasound). The default DICOM export modality is OCT.Photometric Interpretation Check to select the export format for DICOM images: RGB or PALETTE. The default format is RGB. PALETTE yields smaller file sizes.Don’t include region calibration informationIf this box is checked, region calibration informa-tion is not included in the DICOM data.Table 10-10: Setup - DICOM/Image Options Menu Settings (continued)
User Interface ReferenceSetup - DICOM/Local Host MenuILUMIEN OPTIS SystemInstructions for Use 10-19Setup - DICOM/Local Host MenuTable 10-11: Setup - DICOM/Local Host Menu SettingsHostname The name used to identify the ILUMIEN OPTIS System on the network. This name is shown for display purposes only and cannot be modified.IP Address The IP address of this computer on the network. The default value is determined using DHCP when the network adapter is initialized.NOTE: If the Obtain an IP Address Automatically option is checked,this is unavailable.NOTE: Setting the IP address to an address used by another system onthe network may cause network instability.Figure 10-10: Setup - DICOM/Local Host Menu
User Interface ReferenceSetup - DICOM/Local Host MenuSt. Jude Medical10-20 Part Number ARTUS100109403Subnet Mask The subnet mask number which is combined with the Local IP Address to identify which network segment this computer is on. The default value is determined using DHCP when the network adapter is initialized.NOTE: If the Obtain an IP Address Automatically option is checked,this is unavailable.Gateway The IP address of the default gateway, IP router, to be used to forward network traffic beyond the local network. The default value is deter-mined using DHCP when the network adapter is initialized.NOTE: If the Obtain an IP Address Automatically option is checked,this is unavailable.Obtain an IP Address AutomaticallyWhen checked, the IP Address of the Local Host, Subnet Mask, and Gateway are obtained by the system using DHCP, and cannot be edited on the ILUMIEN OPTIS System.Uncheck this option to modify the IP Address of the Local Host, Sub-net Mask, and Gateway.Table 10-11: Setup - DICOM/Local Host Menu Settings (continued)
User Interface ReferenceSetup - Display MenuILUMIEN OPTIS SystemInstructions for Use 10-21Setup - Display MenuTable 10-12: Setup - Display Menu SettingsGraduated Cut PlaneCheck this checkbox to add graduated marks to the cut plane indi-cator to use as scale marks.Figure 10-11: Setup - Display Menu
User Interface ReferenceSetup - Display MenuSt. Jude Medical10-22 Part Number ARTUS100109403Crosshair On/OffCheck this checkbox to add scaled crosshairs to the cross section view. Colormap Click the arrow on the Colormap drop-down menu to display the list of colors. Click a color to select it.L-Mode (Smoothing) Click to select the amount of smoothing (averaging) for L-Mode views. The default setting is Low.Lumen Profile MeasuresSelect the type of measurements to be represented in the Lumen Profile view. The default value is Mean Diameter. When Mean Diameter is selected, %DS values are displayed in the Lumen Pro-file view. These values are changed to %AS when Area is selected.Show Extended MLA InfoCheck to include the %DS (or %AS) values of the MLA with respect to both the Proximal and Distal Reference frames. This is in addition to the %DS (or %AS) value of the MLA with respect to the mean of the Proximal and Distal reference frames.Quick Zoom FactorsSelect the first click and second click zoom factor for the 2D, 3D, and Angio displays. Available choices for the first click setting are: 2.0x; 3.0x; 4.0x; 5.0x; 6.0x; and 7.0x. The second click setting can be set to a zoom factor greater than or equal to the first click setting. If the first click and second click settings are set to the same value then the first click will zoom in and the second click will zoom out. If the two settings are different then the first and second clicks will zoom in to their zoom factor, and the third click will zoom out. The default values are 3.0x and 6.0x respectively.Show Vessel/Procedure Check this box to present the Vessel and Procedure value on the exported DICOM image. The default is unchecked.Table 10-12: Setup - Display Menu Settings (continued)
User Interface ReferenceSetup - Measurements MenuILUMIEN OPTIS SystemInstructions for Use 10-23Setup - Measurements MenuTable 10-13: Setup - Measurements Menu SettingsPen ColorList of pen colors that can be used for subsequent measurements and calculations. If Auto Cycle is selected, the pen color used for measure-ments is automatically changed to the next color after a new measure-ment is completed.Line Width List of line widths that can be used for subsequent measurements and calculations. The default is 1pt.Control Point SizeList of point sizes that can be used for subsequent length and two-point circular area measurements. The default is Medium.Figure 10-12: Setup - Measurements Menu
User Interface ReferenceSetup - Measurements/Labels MenuSt. Jude Medical10-24 Part Number ARTUS100109403Setup - Measurements/Labels MenuTable 10-14: Setup - Measurements/Labels Menu SettingsDefault LabelsLabel text that will be used when making the indi-cated type of measurement.Click and type in any field to change that label.Figure 10-13: Setup - Measurements/Labels Menu
User Interface ReferenceSetup - Print MenuILUMIEN OPTIS SystemInstructions for Use 10-25Setup - Print MenuTable 10-15: Setup - Print Menu SettingsUSB File Format Click to choose the format used when printing a file to a USB drive.Figure 10-14: Setup - Print Menu
User Interface ReferenceSetup - Service MenuSt. Jude Medical10-26 Part Number ARTUS100109403Setup - Service MenuThe Service menu in the Setup dialog box displays service logs to help St. Jude MedicalService analyze problems which may occur during system operation. If you encounterproblems while using the system, you may be asked to access and report information fromthis menu.Figure 10-15: Setup - Service Menu
User Interface ReferenceSetup - Service MenuILUMIEN OPTIS SystemInstructions for Use 10-27Table 10-16: Setup - Service Menu SettingsService Log (View)Click the View button to open the Service Event Viewer.Click on a column header to sort the patients according to data in that column. Click the buttons at the top to show or hide cate-gories of information:•Errors - lists all the operating errors logged by the system.•Warnings - lists all the Warning prompts displayed during opera-tion.•Information - lists selected system status events which may help diagnose problems.•No Category - Displays entries that do not have a Category listed.•Patient - lists all changes and import/export of patient data.Service Log (Export)Click the Export button to open the Transfer Event Log Files menu, to export the Event Log files to a specified drive. See “Transfer Event Log Files Menu” on page 9-11 for more information.Operating ModeClick the Change button to open the System Configuration Utility window to change the application type and/or operating mode.A password is required to open the configuration utility.DOC Service Click Enter to perform DOC maintenance, including cleaning or replacing the Optical Adapter.Field Service ToolClick Launch to start the Field Service Utility.NOTE: The service utility is for use by trained Field Service Engi-neers. A password is required to open the service utility.External Monitor This feature is not used on the OPTIS Integrated system.ButtonsHeaders
User Interface ReferenceSetup - Service MenuSt. Jude Medical10-28 Part Number ARTUS100109403Calibration OptionsThe Hide Calibration checkbox controls the display of the calibra-tion sequence when a catheter is first connected to the DOC.Checked - The calibration sequence is hidden.Unchecked - The calibration sequence is displayed on screen.Table 10-16: Setup - Service Menu Settings (continued)
User Interface ReferenceSetup - Service/System Diagnostics MenuILUMIEN OPTIS SystemInstructions for Use 10-29Setup - Service/System Diagnostics MenuThe System Diagnostics menu in the Setup dialog box is provided to help St. Jude Med-ical Service monitor and analyze signal levels in the imaging engine either in real time orat the time a recording was made. When the tab is selected the system immediately dis-plays the detected signal levels while in Acquisition mode or the signal values when thecurrent image was captured when in Playback mode. If you encounter problems whileusing the system, you may be asked to access and report information from this tabTable 10-17: Setup - Service/System Diagnostics Menu SettingsPower Supplies +5VA Supply - The +5 volt AC power supply voltage.+5VD Supply - The +5 volt DC power supply voltage.+24VD Supply - The +24 volt DC power supply voltage.DOC Current - The current being drawn by the DOC in mA.Figure 10-16: Setup - Service/System Diagnostics Menu
User Interface ReferenceSetup - Service/System Diagnostics MenuSt. Jude Medical10-30 Part Number ARTUS100109403SLC Interlock - Displays the SLC interlock state.Reference Power - Displays the reference power value in %.Ref. Power Warning - Reference Power Warning value in %.Z-Offset Position - Z-Offset Position value in millimeters.Start Polling / Stop Polling Starts/stops automatic update of these values, in real time, every 50 milli-seconds.NOTE: During playback, the Polling button is disabled, and the valuesrepresent the signal levels of the imaging engine at the imagerecording time.Table 10-17: Setup - Service/System Diagnostics Menu Settings (continued)
ILUMIEN OPTIS SystemInstructions for Use 11-1Safety Information 11Although the ILUMIEN OPTIS System conforms to laser emission standards and both inter-national and European safety and electromagnetic compatibility standards, the system isintended for use only by medical personnel who have received ILUMIEN OPTIS Systemtraining. Only a trained operator can determine if ILUMIEN OPTIS System use is appropri-ate. An awareness of the system’s limitations is essential to making that determinationand assuring safe operation for both operator and patient.This chapter includes:• Precautions to assure patient and operator safety.• How to avoid optical, electrical, explosion, and defibrillator hazards.• How to make proper electrical connections.• System imaging limitations.• How to trace the source of electromagnetic interference.CAUTION: Before using the ILUMIEN OPTIS System for the first time, be sure toread and understand all of the information in this chapter.NOTE: The ILUMIEN OPTIS System complies with FDA performance standards forlaser products except for deviations pursuant to laser Notice No. 50, datedJuly 26, 2001.NOTE: LightLab Imaging, Inc. hereby declares that OPTIS Integrated system is incompliance with the essential requirements and other relevant provisionsof Directive 1999/5/EC. A copy of the Full Declaration of Conformity canbe obtained by contacting the EU Representative.
Safety InformationPatient SafetySt. Jude Medical11-2 Part Number ARTUS100109403Patient SafetyThe ILUMIEN OPTIS System is intended for use only by medical personnel trained in itsoperation and skilled in the clinical procedures to be used.To avoid any potential hazard to patients, follow the precautions outlined in this section.CAUTION: Use only the Dragonfly Imaging catheters with the ILUMIEN OPTISSystem. Use of other types of catheters may result in unsafe conditionsfor the patient and damage the ILUMIEN OPTIS System.GeneralWARNING: Failure to follow the guidelines described in these Instructions for Useand in the Instructions for Use provided with the accessories mayresult in injury to patients and damage to equipment.• Only use Dragonfly™ Imaging Catheters. Always use under appropriate imagingguidance (endoscopy, x-ray fluoroscopy, or other appropriate guidance method).• Only use PressureWire pressure transducers to report aortic distal pressure. Alwaysuse under appropriate imaging guidance (endoscopy, x-ray fluoroscopy, or otherappropriate guidance method).• Always read and follow the Instructions for Use supplied with the Dragonfly Imag-ing Catheter and with the PressureWire catheter.• Always use controls, make adjustments and perform procedures as specified inthese Instructions for Use.Techniques to Minimize Patient ExposureThe ILUMIEN OPTIS System meets the performance standards of laser-emitting productsas established by IEC 60825-1. Although no harmful effects have been demonstrated forthe near-infrared light wavelengths, intensities, and exposure times used during examina-tions with the ILUMIEN OPTIS System, St. Jude Medical recommends that you carefullyread the warning labels on the system (see Figure 11-1) and follow these examinationguidelines:• Use OCT only when there is a good reason to do so.• Use techniques that enable quick collection of clinical data and shorten proceduretime.
Safety InformationOperator SafetyILUMIEN OPTIS SystemInstructions for Use 11-3Operator SafetyAvoiding Operator Light Emission HazardsTo avoid any potential light emission hazards to yourself or patients, adhere to the infor-mation provided in the safety labels that are located on the system (see Figure 11-1), andobserve the precautions outlined in this section.WARNING: Failure to follow any of these precautions may cause possible seriousdamage to your eyes.• Avoid eye exposure. Do not look at or stare directly into the beam. Doing so maydamage your eyes.• Never view the laser output with optical instruments (for example, eye loupes, mag-nifiers, and microscopes). Doing so may damage your eyes.• Use controls, make adjustments, and perform procedures only as specified in theseInstructions for Use.Repetitive Strain Injury (RSI)Repetitive use of a mouse and keyboard has been associated with Carpal Tunnel Syn-drome (CTS) and related musculoskeletal problems. Follow these suggestions to helpprevent these problems:• Maintain your joints in optimum positions with a balanced posture, avoiding:• Static postures.• Exertion of force during repetitive motions.• Wrist flexion or deviation.• Position the keyboard and monitor to minimize reaching and stretching.• Take frequent breaks to give tissues time to recuperate from awkward positions andrepetitive movements.Figure 11-1: Connector Panel Laser Safety Labels
Safety InformationMoving the SystemSt. Jude Medical11-4 Part Number ARTUS100109403Moving the SystemWhen moving the system, observe these precautions:WARNING: Failure to follow any of these precautions may lead to a system tippinghazard, causing possible injury to people and damage to the system.• Be sure to turn off and disconnect the system cord from the wall outlet before begin-ning a move.• Position the DOC cable appropriately before moving the system.• The system weighs up to 95 kg (209 lbs) with all accessories installed, two peopleare required when moving it.• Make sure that the system’s wheels roll freely before beginning the move. Resolveany wheel problems before you move the system.NOTE: Be sure the system brakes are in the up position (unlocked).• To eliminate the potential danger of the system’s tipping over, avoid ramps that aresteeper than 5 degrees.• Do not push the system by the monitors or monitor support mount.• If you must move the system up or down ramps with an incline of more than 5degrees, use two people.• Do NOT lift a cart bearing the system to move it over uneven elevator entrances orother steps and barriers. Instead, find a route that avoids such problems.NOTE: Wheelchair ramps usually have an incline of less than 5 degrees.• When using a transport vehicle, be sure that it can handle the weight of the systemcomponents plus passengers.• If a lift is used be sure the load capacity of the lift can accommodate the weight ofthe system components plus passengers.
Safety InformationAvoiding Electrical HazardsILUMIEN OPTIS SystemInstructions for Use 11-5Avoiding Electrical HazardsThe isolation transformer in the ILUMIEN OPTIS System provides electrically isolatedpower to components supplied with the system or specified as part of the system.WARNING: All system components except the isolation transformer itself MUSTbe powered by, and only by, the isolation transformer in the ILUMIENOPTIS System.This electrical isolation separates the system components, and thus the patient, from dan-gerous leakage currents. If any of the system’s components are directly connected to awall outlet or some power source other than the isolation transformer, the patient and theoperator are no longer safely isolated and may be exposed to dangerous electric currents.WARNING: Failure to abide by the precautions detailed below causes the systemand its use to be out of compliance with regulations and places thepatient and the operator at risk of injury or death.• Do NOT use additional cables, extension cords or outlets with the ILUMIEN OPTISSystem.NOTE: The ILUMIEN OPTIS System’s isolation transformer creates an elec-trically isolated Patient Interface for invasive imaging. This electri-cally isolated condition must be maintained throughout theprocedure or during any contact with the patient.• When transferring files inside the catheterization lab, use only port-powered USBdrives.WARNING: Inside the catheterization lab only port-powered USB drivesmay be connected to the USB port. Connecting externally pow-ered devices to the USB port in the patient vicinity may compro-mise electrical isolation and cause patient injury.NOTE: Outside the catheterization lab, IEC 60950-compliant, externallypowered USB hard drives may be connected to the USB port.• Do NOT remove system covers. Only qualified personnel should service the sys-tem. Accidentally contacting the electrical circuits inside the housing could causeserious injury.
Safety InformationMaking Proper Electrical ConnectionsSt. Jude Medical11-6 Part Number ARTUS100109403Making Proper Electrical ConnectionsEnsure the electrical connection for the system is properly rated (see Figure 11-2). Care-fully follow the safety guidelines described in this section when connecting your system’spower cord to the hospital or lab’s AC outlet.WARNING: Failure to follow the electrical connection precautions detailed in thissection causes the system and its use to be out of compliance with reg-ulations and places the patient and the operator at risk of injury ordeath and may damage the equipment.• Connect the system only to properly grounded (three-hole) hospital-grade AC out-lets:• The circuit must accommodate an additional load of up to 400 VA.• Replacement fuses are available through St. Jude Medical, part number: 11559-02FUSE• The power cord is to be used for disconnection from main power.• Make sure that any devices that connect to the network interface of the ILUMIENOPTIS System comply with the appropriate IEC/national standard and are certifiedto IEC 60950.• Use no electrical peripherals within six feet of a patient unless the peripheralsreceive power from an isolation transformer that meets medical safety standards.NOTE: If the ILUMIEN OPTIS System is used with peripherals that are pow-ered from a separate wall outlet, then the combination is consideredto be a Medical System. It is the user’s responsibility to comply withIEC 60601-1-1 and test the Medical System according to the require-ments.Figure 11-2: Electrical Label
Safety InformationExplosion HazardILUMIEN OPTIS SystemInstructions for Use 11-7Explosion HazardWARNING: Do NOT operate the ILUMIEN OPTIS System in the presence of flam-mable anesthetics. Doing so could lead to an explosion.System Imaging LimitationsThe ILUMIEN OPTIS System is intended for use by medical personnel who have receivedtraining in the use of the system. To determine if system use is appropriate, the traineduser must be aware of system imaging limitations.CAUTION: Use only the Dragonfly™ Imaging catheters with the ILUMIEN OPTISSystem. Other types of catheters may break if used.This section includes information about system capabilities and limitations for both ves-sel and tissue imaging.Considerations for Optimal Vessel ImagingThe ILUMIEN OPTIS System can be used to image through vessels or to image the innersurface of certain vessels. Since the Dragonfly catheter is smaller than the diameter of thevessel being imaged, the position of the catheter in the vessel has an effect on the portionof the vessel that can be imaged.• Imaging range is greatest when the imaging catheter is centered in the lumen.• Imaging range is least when the imaging catheter is placed eccentrically (off-center)in the lumen, against the wall of the vessel.Considerations for Optimal Tissue ImagingThe maximum imaging depth within a vessel wall ranges from approximately 0.9 mm to1.3 mm and is limited by optical attenuation caused by scattering of the optical beam bymicrostructures in the vessel. For example, penetration of the OCT beam is deepest in cal-cified tissue and shallowest in dense fibrotic tissue.
Safety InformationElectromagnetic CompatibilitySt. Jude Medical11-8 Part Number ARTUS100109403Electromagnetic CompatibilityThe ILUMIEN OPTIS System is designed to meet the following electromagnetic compati-bility standards:• IEC 60601-1-2 (US and International).• EN 60601-1-2 (Europe).Electromagnetic InterferenceThe system produce images by using digital signal processing techniques that operate inthe radio frequency (RF) energy range. The system is therefore susceptible to interferencegenerated by other RF energy sources such as medical devices, information technologyproducts, or radio/television transmission towers. Tracing the source of radiated interfer-ence can be difficult.In accordance with the standards identified in these Instructions for Use, no interferencewas observed. However, the trained user must determine if an artifact caused by radiatedinterference will negatively impact image quality and the subsequent study results.To help identify the source of electromagnetic interference, ask the following questions:• Is the interference intermittent or constant?• Does the interference occur with one catheter only, or with other imaging catheters?• Is the interference present if the system is moved to a different location in the facil-ity? Examples: Placing the system close to an ECG cable can increase electromag-netic interference. Moving the cable or other medical equipment away from thesystem can reduce electromagnetic interference.Please answer these questions before contacting your service representative. The answerswill help a service representative determine if the problem is in the system or in the imag-ing environment.
Safety InformationSafety Functions Built Into the Ilumien Optis SystemILUMIEN OPTIS SystemInstructions for Use 11-9Safety Functions Built Into the ILUMIEN OPTIS SystemThe following safety functions have been built into the system:• The system disables light output and disables all motors in these situations:• The optical fiber stops rotating due to mechanical failure.• Communication is lost between the imaging engine and the DOC.• Communication is lost between the computer and the imaging engine.• Pressing the Stop button on the DOC disables power to the DOC and laser output(see “The Drive-motor and Optical Controller (DOC)” on page 1-10).
Safety InformationSafety Functions Built Into the Ilumien Optis SystemSt. Jude Medical11-10 Part Number ARTUS100109403
ILUMIEN OPTIS SystemInstructions for Use 12-1System Specifications 12System - Safety & RegulatoryTable 12-1: System Safety & Regulatory SpecificationsCategory SpecificationsRegulatory Approvals US 510(k) clearance. Safety standards system meets: IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007)EN60601-1: 2006, “Medical Electrical Equipment, Part 1: General Requirements for Safety”EN60601-1-2: 2007, Electromagnetic Radiated Emissions Requirements for Medical Electrical Equipment - Group 1 Equipment, Class B for Non-Life Supporting EquipmentUL60601-1: 2003, “Medical Electrical Equipment, Part 1: General Requirements for Safety”CAN/CSA C22.2 No. 60601-1:2008, “Medical Electrical Equipment, Part 1: General Requirements for Safety”IEC 60825-1, 2nd Ed., 2007: Safety of Laser ProductsElectromagnetic compatibil-ity (EMC) Refer to Table 12-5, Table 12-6, Table 12-7, and Table 12-8 for detailed specifications.
System SpecificationsSystem - Safety & RegulatorySt. Jude Medical12-2 Part Number ARTUS100109403ClassificationsType of protection, shock Class 1Degree of protection, shock Type CF• DOC with catheter (CF label at DOC cable exit on Con-nector Panel)Degree of protection, ingress Console - IPX0DOC - IPX0, use with Sterile DOC cover for ingress protec-tionMethod of Disinfection Console and DOC will withstand without damage or deterio-ration disinfection by wiping with common hospital disinfec-tants including Cidex (Glutaraldehyde 3.4%).Flammable mixtures Not for use in presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide.Mode of operation ContinuousLeakage & Auxiliary CurrentChassis leakage current < 100 µa rms normal condition< 500 µa rms single-fault conditionPatient leakage current Measured at patient end of DOC:< 10 µa rms normal condition< 50 µa rms single-fault conditionSoftware Safety FeaturesThe computer and software are designed with the following security features. These features do not require any user configuration or action.• Prevents unauthorized access to the operating system.• Prevents installation or execution of unauthorized software• Prevents infiltration via Ethernet connection.• Performs data integrity check when archiving data to external media.Table 12-1: System Safety & Regulatory Specifications (continued)Category Specifications
System SpecificationsSystem - Electrical and PhysicalILUMIEN OPTIS SystemInstructions for Use 12-3System - Electrical and PhysicalTable 12-2: System Electrical and Physical SpecificationsParameter SpecificationPower InputLine voltage 100/120/220/240 VAC ±10%, user selectable50/60 Hz ±1 HzPower consumption Active: < 400 VAStandby: < 30 VATransport and Storage Conditions (Permissible ranges)Ambient temp -25 to +50 degrees CRelative humidity 10% - 95%, including condensingAtmospheric pressure 500 to 1060 mBarOperating ConditionsAmbient temperature +10 to +32 degrees CRelative humidity 10% to 85%, non-condensingAtmospheric pressure 700 to 1060 mBarMechanical SpecificationsWeight 95 kg (209 lbs) max with all accessoriesOverall Dimensions 145 cm H x 61 cm W x 71 cm D ±5 mm
System SpecificationsImaging SpecificationsSt. Jude Medical12-4 Part Number ARTUS100109403Imaging SpecificationsTable 12-3: Imaging SpecificationsParameter SpecificationOptical Parameters - Measured at System Aperture (DOC Optical Port)Scanning Laser Source Optical Power 22.6 mW maximum @ 1305 nm ±55 nm(Class 1M Laser Output per IEC 60825-1)Visible Laser Optical Power 1.45 mW maximum @ 670 nm (nominal)(Class 1M Laser Output per IEC 60825-1)Pullback ParametersPullback Range 75 mm(If connected to a C7 Dragonfly catheter, the range is 54 mm.)Pullback Speed Settings 18.0 mm/sec, 36.0 mm/sec(If connected to a C7 Dragonfly catheter, the speed set-tings are 10.0 mm/sec, 20.0 mm/sec, 25.0 mm/sec.)General Scan ParametersA-Scan Range in Air 7.0 mmA-Scan Range in Contrast 4.83 mmDiameter Measurement Accuracy 7% ±0.1 mmArea Measurement Accuracy 10% ±0.1 mm2Axial Resolution  20 µm in tissueOptical Sensitivity 90 db minimumA-Scans per second 90 kHz (nominal)Frame Rate 180 frames/second (Hz)(If connected to a C7 Dragonfly catheter, the Frame Rate is 100 frames/second (Hz).)
System SpecificationsFFR SpecificationsILUMIEN OPTIS SystemInstructions for Use 12-5FFR SpecificationsTable 12-4: FFR SpecificationsParameter SpecificationAO Pressure (Wi-Box to ILUMIEN OPTIS System)Operating pressure -200 to +450 mm HgAccuracy +/- 1 mm Hg or +/- 1% of reading, whichever is greaterPW PressureOperating pressure -30 to +300 mm HgAccuracy ±1 mm Hg plus ±1% of reading (-30 to 50 mm Hg) ±3% of reading (50 to 300 mm Hg)AO Pressure (Wi-Box to hemodynamic recording system)Direct galvanic connectionMax pressure shift <2 mm HgRadio SpecificationFrequency range 2.4000 - 2.4835 GHzType Frequency hopping spread spectrum (FHSS)Range 0 - 4 mDelay time <20 ms
System SpecificationsElectromagnetic EmissionsSt. Jude Medical12-6 Part Number ARTUS100109403Electromagnetic EmissionsTable 12-5: Guidance and Manufacturer’s Declaration - Electromagnetic EmissionsThe ILUMIEN OPTIS System is intended for use in the electromagnetic environmentspecified below. The customer or user of the ILUMIEN OPTIS System should assurethat it is used in such an environment.Emissions Test Compliance Electromagnetic Environment - GuidanceRF emissionsCISPR 11 Group 1 The ILUMIEN OPTIS System uses RF energy only for its internal function. Therefore, its RF emis-sions are very low and not likely to cause any interference with nearby electronic equipment.RF emissionsCISPR 11 Class B The ILUMIEN OPTIS System is suitable for use in all establishments, including domestic establish-ments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic proposes.Harmonic emissionsIEC 61000-3-2 Class AVoltage fluctuations/ flicker emissionsIEC 61000-3-3Complies
System SpecificationsElectromagnetic ImmunityILUMIEN OPTIS SystemInstructions for Use 12-7Electromagnetic ImmunityTable 12-6: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The ILUMIEN OPTIS System is intended for use in the electromagnetic environmentspecified below. The customer or user of the ILUMIEN OPTIS System should assurethat it is used in such an environment.Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - GuidanceElectrostatic dis-charge (ESD)IEC 61000-4-2± 6 kV contact± 8 kV air ± 6 kV contact± 8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.Electrical fast tran-sient/burstIEC 61000-4-4± 2 kV for power sup-ply lines± 1 kV for input/out-put lines± 2 kV for power sup-ply lines± 1 kV for input/out-put linesMains power quality should be that of a typi-cal commercial or hos-pital environment.SurgeIEC 61000-4-5 ± 1 kV lines(s) to line(s)± 2 kV lines(s) to earth± 1 kV lines(s) to line(s)± 2 kV lines(s) to earthMains power quality should be that of a typi-cal commercial or hos-pital environment.Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11< 5 % UT(>95% dip in UT) for 0.5 cycle40% UT(>60% dip in UT)for 5 cycles70% UT(30% dip in UT) for 25 cycles<5% UT(>95% dip in UT) for 5 seconds< 5% UT(>95% dip in UT) for 0.5 cycle40% UT(>60% dip in UT) for 5 cycles<70% UT(>30% dip in UT) for 25 cycles<5% UT(>95% dip in UT) for 5 secondsMains power quality should be that of a typi-cal commercial or hos-pital environment. If the user of the ILUMIEN OPTIS System requires continued operation during power mains interruptions, it is rec-ommended that the ILUMIEN OPTIS be pow-ered from an uninter-ruptible power supply or battery.NOTE: UT is the AC mains voltage prior to application of the test level.
System SpecificationsElectromagnetic ImmunitySt. Jude Medical12-8 Part Number ARTUS100109403Power frequency (50/60 Hz) magnetic fieldIEC 61000-4-83 A/m 3 A/m Power frequency mag-netic fields should be at levels characteristic of a typical commercial or hospital environment.Table 12-6: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The ILUMIEN OPTIS System is intended for use in the electromagnetic environmentspecified below. The customer or user of the ILUMIEN OPTIS System should assurethat it is used in such an environment. (continued)Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance
System SpecificationsElectromagnetic ImmunityILUMIEN OPTIS SystemInstructions for Use 12-9NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagationis affected by absorption and reflection from structures, objects, and people.Table 12-7: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The ILUMIEN OPTIS System is intended for use in the electromagnetic environmentspecified in this section. The customer or user of the ILUMIEN OPTIS System shouldassure that it is used in such an environment.Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - GuidanceConducted RFIEC 61000-4-6Radiated RFIEC 61000-4-33 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz3 Vrms3 V/mPortable and mobile RF communica-tions equipment should be used no closer to any part of the ILUMIEN OPTIS System, including cables, than the rec-ommended separation distance calcu-lated from the equation applicable to the frequency of the transmitter.Recommended separation distance 80 MHz to 800 MHz 800 MHz to 2.5 GHzWhere P is the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufac-turer and d is the recommended separa-tion distance in meters (m).Field strengths from fixed RF transmit-ters, as determined by an electromag-netic site surveya, should be less than the compliance level in each frequency rangeb.Interference may occur in the vicinity of equipment marked with this symbol:d1.2P=d1.2P=d2.3P=
System SpecificationsElectromagnetic ImmunitySt. Jude Medical12-10 Part Number ARTUS100109403a Field strengths from fixed transmitters, such as base stations for radio (cellu-lar/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broad-cast and TV broadcast cannot be predicted theoretically with accuracy. To assess theelectromagnetic environment due to fixed RF transmitters, an electromagnetic site surveyshould be considered. If the measured field strength in the location in which the ILUMIENOPTIS System is used exceeds the applicable RF compliance level above, the ILUMIENOPTIS System should be observed to verify normal operation. If abnormal performance isobserved, additional measures may be necessary, such as re-orienting or relocating theILUMIEN OPTIS System.b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
System SpecificationsRecommended Separation DistancesILUMIEN OPTIS SystemInstructions for Use 12-11Recommended Separation DistancesFor transmitters rated at a maximum output power not listed above, the recommendedseparation distance d in meters (m) can be estimated using the equation applicable to thefrequency of the transmitter, where P is the maximum output power rating of the transmit-ter in watts (W) according to the transmitter manufacturer.NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequencyrange applies.NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagationis affected by absorption and reflection from structures, objects, and people.Table 12-8: Recommended separation distances between portable and mobile RF com-munications equipment and the ILUMIEN OPTIS SystemThe ILUMIEN OPTIS System is intended for use in an electromagnetic environmentin which radiated RF disturbances are controlled. The customer or the user of theILUMIEN OPTIS System can help prevent electromagnetic interference by maintain-ing a minimum distance between portable and mobile RF communications equip-ment (transmitters) and the ILUMIEN OPTIS System as recommended below,according to the maximum output power of the communications equipment.Rated maximum output power of transmitter Separation distance according to frequency of transmitter mW 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz0.01 0.12 0.12 0.230.1 0.38 0.38 0.731 1.2 1.2 2.310 3.8 3.8 7.3d1.2P=d1.2P=d2.3P=
System SpecificationsFCC StatementSt. Jude Medical12-12 Part Number ARTUS100109403FCC StatementThis equipment has been tested and found to comply with the limits for a Class A digitaldevice, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reason-able protection against harmful interference when the equipment is operated in a commer-cial environment. This equipment generates, uses and can radiate radio frequency energyand, if not installed and used in accordance with the instruction manual, may cause harm-ful interference to radio communications. Operation of this equipment in a residentialarea is likely to cause harmful interference in which case the user will be required to cor-rect the interference at his own expense.Operation is subject to the following two conditions: (1) this device may not cause harm-ful interference, and (2) this device must accept any interference received, includinginterference that may cause undesired operation.Changes or modifications not expressly approved by St. Jude Medical could void theuser’s authority to operate the equipment.Essential Performance Defined by Operating ModeDuring testing, the OCT Imaging System (MN: C8/OPTIS Integrated) was operating asfollows: SSOCT Data Viewer is displaying white noise. The CardioUI Development soft-ware is running. The probe is active and displaying an image. Image on screen is stableand without error. Also host PC is pinging the EUT.
ILUMIEN OPTIS SystemInstructions for Use Index-1IndexSymbols%AS, 7-2, 7-10%DS, 7-2, 7-12Numerics3D Display, 7-23AAcquisition mode, 10-29Adding Points, 7-18Annotationadding text, 7-8text, 7-9Area Measurementsautomatic, 7-6Auto Cycle Drawing Color, 10-23Automatic MLA and %DS option, 7-20BBlack Level, 9-15Bookmarkclear all bookmarks, 6-10creating, 6-10next bookmark, 6-10previous bookmark, 6-10CCalculation%AS, 7-10%DS, 7-12Calloutadding, 7-9position, 7-9Calloutsadding, 7-8Catheterconnection to DOC, 4-5, 5-8disconnecting from DOC, 5-18insertion, 5-13positioning, 5-13preparation, 5-7purge, 5-9removal, 5-18stop movement, 5-19Caution, meaning and format, Front-ivCleaning, 9-2Complications, 1-16Complications from Use, 1-16Connectionnetwork, 1-8power, 2-2USB, 1-8video, 1-8Connector Panellocation, 1-4Contact Informationcompany, Front-iiservice, 9-2Contraindications for Use, 1-13Control Point Size, 10-23Conventions Used in Manual, Front-ivCreating a New Patient, 3-6Cross-section Viewzoom, 7-15
IndexDSt. Jude MedicalIndex-2 Part Number ARTUS100109403DDatabasecreate a new patient, 3-6import, 8-20Setup dialog box, 10-7statistics, 8-26, 10-9Database Tab, 10-7Deletefiles, 8-23measurements, 7-19points, 7-18Depth Calibration Marks, 5-16Diagnostics Tab, 10-29DICOMviewer, 8-16DICOM Tab, 10-12DOC catheter connection, 4-5, 5-8cleaning optical connection, 9-5description, 1-10preparation, 5-6replacing optical adapter, 9-8Drive-motor and Optical Controller, 1-10EElectrical Connections, 11-6Electrical Hazards, 11-5Enable button on DOC, 1-10External Drive, 8-9, 8-10, 8-12FFFR Procedurecatheter connection, 4-5materials and equipment, 4-1File Size, 8-6Files deleting, 8-23Flush Mediumwarning, 1-14GGreen’s Theorem, 7-6HHazardselectrical, 11-5explosion, 11-7light emission, 11-3repetitive strain injury, 11-3Home menu, 3-2IImage Compressioncaution, 7-1, 8-7Image Formatraw, 8-4standard, 8-5Imaginglimitations, 11-7tissue, 11-7vessel, 11-7Imaging Specificationsoptical parameters, 12-4pullback parameters, 12-4scan parameters, 12-4Import OCT Files, 8-20Indications for Use, 1-12Infection Control, 9-13Instructions for Useother manuals, Front-ivIntended Use, 1-12LLength Measurement, 7-5Line Width, 10-23Live Mode, 10-29Live View, 5-3Live View Button on DOC, 1-10
IndexMILUMIEN OPTIS SystemInstructions for Use Index-3L-Modecaution, 7-3cut-plane, 5-16limitations, 6-5measurements and annotations, 7-3Lock LED on DOC, 1-10Log Files, 9-11, 10-26Lumen Profile, 7-20MMaintenance, 9-4Manualconventions, Front-ivMeasurement Accuracy, 7-3Measurement and Annotation tools, 7-2Measurementsadding points, 7-18caution, 7-1, 8-7deleting all measurements, 7-19deleting individual measurements, 7-19deleting measurements, 7-19deleting points, 7-18editing, 7-17length, 7-5moving individual points, 7-18Minimum Lumen Area, 7-21MLA, 7-21Monitor Setup, 2-6Moving Points, 7-18Moving System, 11-4NNear-infrared Light, 1-1, 11-2Network Connection, 1-8Note, meaning and format, Front-ivOOCT Database, see DatabaseOCT Procedurecatheter connection, 5-8catheter insertion, 5-13catheter positioning, 5-13catheter preparation, 5-7completing procedure, 5-18DOC preparation, 5-6materials and equipment, 5-1recording, 5-16Operator Safetylight emission hazards, 11-3moving the system, 11-4repetitive strain injury, 11-3Optical Coherence Tomography, 1-1Optical Parameters, 12-4Optimal Tissue Imaging, 11-7Optimal Vessel Imaging, 11-7PPatientacquiring image, 5-16creating a record, 3-6minimizing exposure, 11-2safety, 11-2Patient Entrycreating, 3-6Patient RecordOpen, Create, 3-1Pen Color, 10-23Percent Area Stenosis, 7-2, 7-10Percent Diameter Stenosis, 7-2, 7-12PIU. See DOCPlayback Calibrationsetting, 6-7Playback Mode, 10-29playback range, 6-11Positioning the System, 2-1Poweroff, 2-4on, 2-3Power In, 12-3Precautions for Use, 1-15
IndexRSt. Jude MedicalIndex-4 Part Number ARTUS100109403Pullbackparameters, 12-4stop, 5-19trigger, 10-3Pullback motion LEDs on DOC, 1-10Purge Catheter, 5-9RRangeplayback, 6-11Raw Formatdescription, 8-4Recordingstatus, 5-16Recording calibration marks, 5-16Remote DICOM Store, 8-11Reviewingsaved images, 6-1SSafetyfunctions, 11-9operator, 11-3patient, 11-2Segmented Lumen, 7-25Select Measurementpercent area stenosis, 7-10percent diameter stenosis, 7-12Select Patient menu, 3-2Service Tab, 10-26Setup Dialog BoxDatabase tab, 10-7Diagnostics tab, 10-29DICOM tab, 10-12Service tab, 10-26Shutdownprocedure, 2-4Specificationselectrical and physical, 12-3electromagnetic, 12-6, 12-7, 12-9imaging, 12-4pressure and radio, 12-5safety and regulatory, 12-1Standard File Format, 8-6Standard Formatdescription, 8-5Standby View, 5-3Stop Button on DOC, 1-10Systemcomponents, 1-2features, 1-1imaging limitations, 11-7moving, 11-4power on, 2-3setup, 2-1shut down, 2-4System Displayduring image acquisition, 5-16System Specificationsclassifications, 12-2leakage & auxiliary current, 12-2mechanical specifications, 12-3operating conditions, 12-3power input, 12-3software safety features, 12-2transport and storage conditions, 12-3TText adding, 7-8display options, 7-9entry, 7-9position, 7-9Tissue Imaging, 11-7Transfer Messages, 8-24, 8-26Trigger Type, 10-3Troubleshootingconnections, 9-15DOC, 9-15general, 9-14imaging, 9-15PressureWirepower failure, 4-15UUnload button on DOC, 1-10
IndexVILUMIEN OPTIS SystemInstructions for Use Index-5USB connection, 1-8media, 8-2VVessel Imaging, 11-7Video Connection, 1-8WWarning, 1-14Warning, meaning and format, Front-ivWeight, 12-3White Level, 9-15Wi-Boxcathlab installation, 1-11ZZoomDICOM Viewer, 8-17measurements, 7-3region, 7-15
IndexZSt. Jude MedicalIndex-6 Part Number ARTUS100109403

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