St. Jude Medical OPTIS User manual

OPTIS™ Integrated System
Instructions for Use

Information provided within this Document is subject to change without notice and although believed to
be accurate, St. Jude Medical, Inc. and its affiliated companies including without limitation, St. Jude
Medical System AB (Sweden), assume no responsibility for any errors, omissions or inaccuracies.
©2014 St. Jude Medical, Inc. and its related companies. All rights reserved. Reproduction, adaptation,
or translation without prior permission is prohibited, except as allowed under copyright laws.
OPTIS Integrated systems are subject to US Patents 8,412,312, 8,325,419, 6,565,514; GB, FR
0883793, DE 69738291. ILUMIEN, OPTIS, ST. JUDE MEDICAL, LIGHTLAB IMAGING, GOLDEN
IMAGE and the color gold are registered or unregistered trademarks of St. Jude Medical, Inc. and its
related companies.
The OPTIS INTEGRATED system software incorporates third party licensed software as described at the
following URL: www.sjmprofessional.com/ilumien-legal-notices
St. Jude Medical Coordination Center BVBA Australian Sponsor:
The Corporate Village St. Jude Medical Australia Pty Limited
Da Vincilaan 11 Box F1 17 Orion Rd.,
1935 Zaventem Belgium Lane Cove NSW 2066 Australia
[phone] [phone]
LightLab Imaging, Inc. Phone: [phone] US Toll-free
4 Robbins Road [phone] International
Westford, MA 01886
USA
www.sjm.com
Service E-mail: OCT[email protected]
Part Number ARTUS100109403
ENGLISH
Printed in the U.S.A. 4 / 2014
CAUTION: Federal law restricts this device to sale by or on the order of a Physician licensed by
law of the state in which he practices to use or order the use of the device.

ILUMIEN OPTIS System
Instructions for Use iii
SAFETY INFORMATION
Please review this manual carefully before using your OPTIS Integrated System, especially the safety
information in Chapter 11 “Safety Information”. Also, especially note Warnings and Cautions shown
throughout the manual.
WARNINGS
Electrical Shock Hazard
Do not remove OPTIS INTEGRATED System covers. To avoid electrical shock, use only the power cord
supplied with the system and connect only to properly grounded wall outlets. See Chapter 2 “System
Setup” and Chapter 11 “Safety Information” for electrical safety information.
Explosion Hazard
Do not operate the OPTIS INTEGRATED System in the presence of flammable anesthetics. Doing so
could lead to an explosion.
Visible and Invisible Laser Radiation
Do not stare into the beam or view the beam directly with optical instruments. Doing so may cause seri-
ous eye damage and hazardous radiation exposure.
Using These Instructions for Use
This manual describes the St. Jude Medical 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.

iv
Conventions Used in These Instructions for Use
• These abbreviations and shortened expressions are used throughout this manual.
• Software text, and physical button labels are shown in bold type. Examples: the Patient
Summary menu, Settings button.
• Keyboard keys are shown enclosed in carets. Examples: <Enter>, <Ctrl>, <Tab>.
• Warnings, Cautions, and Notes are set apart from other text and appear as shown below.
WARNING: Warnings alert the user to the possibility of injury, death, or
other serious adverse reactions associated with product use or
misuse.
CAUTION: Cautions alert the user to the possibility of a problem with the
product associated with its use or misuse. Problems can include
product malfunctions, product failure, and/or damage to the
product or damage to other property, or loss of data.
NOTE: Notes provide additional information.
Other Instructions for Use
Details of the imaging catheter are covered in the Dragonfly Imaging Catheter Instructions for Use pro-
vided with the catheters and are not covered in this manual.
Details of the PressureWire are covered in the PressureWire Instructions for Use and are not covered in
this manual.
NOTE: Additionally, this manual does not provide detailed discussion of the sys-
tem components, except as they are used with the OPTIS Integrated Sys-
tem.
Table Front-1: Instructions for Use Conventions
Dialog 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 System
Instructions for Use i
Contents
Figures
Tables
System Overview
Optis Integrated System Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1
OPTIS Integrated System Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
OPTIS Integrated System Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Optis Integrated System Cabinet and Control Room Components . . . . . . . .1-4
Optis Integrated System - Mobile Workstation . . . . . . . . . . . . . . . . . . . . . . .1-5
OPTIS Integrated System Table Side Controller. . . . . . . . . . . . . . . . . . . . . .1-6
OPTIS Integrated System DOC Holster. . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7
OPTIS Integrated Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8
The Drive-motor and Optical Controller (DOC). . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
The Wi-Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-11
Indications for Use and Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-12
Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-13
Warnings (OCT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14
Precautions (OCT). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15
Complications (OCT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-16
Warnings and Precautions (FFR). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17
Connecting to External Equipment/Accessories . . . . . . . . . . . . . . . . . . . . . .1-17
Mechanical Enclosure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17
Electrical. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17
Electronic Interference. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17

Contents
ii
Aortic Reference Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18
Pressure Averaging (Mean Setting) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18
Defibrillation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18
Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18
System Setup
Positioning the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
Connecting Your System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
System Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
Powering On and Shutting Down Your System . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
Power On System Cabinet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
Shut Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
FFR Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5
Monitor Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
Setting Monitor Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
Setting Monitor Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
Opening a Patient Record
Select Patient Menu (Home Menu) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
Patient Summary Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
Entering New Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
Editing Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8
Editing Case Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9
Importing a Patient Database. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10
Opening a Saved Recording or Still Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11
Performing an FFR Procedure
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1
Required Material and Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1
Setting up the OPTIS Integrated System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2
Setting up the Wi-Box with the OPTIS Integrated System. . . . . . . . . . . . . . . . . . .4-3
Setting up the PressureWire. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4

Contents
ILUMIEN OPTIS System
Instructions for Use iii
Preparing to Record FFR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
Recording FFR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11
Reviewing an FFR Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13
PressureWire Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15
Performing an OCT Procedure
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1
Required Material and Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1
OCT Imaging Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2
OCT Operating Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3
OCT Recording Types. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3
OCT Trigger Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4
Angio-Coregistration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-5
Setting up the OPTIS Integrated System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-5
Setting up the DOC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6
Setting up the Dragonfly Imaging Catheter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-7
Preparing to Acquire OCT Recordings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8
Confirm Recording Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-12
Dragonfly Imaging Catheter Insertion and Positioning. . . . . . . . . . . . . . . . . . . . . .5-13
Acquiring Patient Images. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-16
Removing the Dragonfly Imaging Catheter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-18
Troubleshooting OCT Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-19
Immediately Stopping DOC Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-19
Catheter Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-20
Reviewing OCT Recordings
Image Window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2
L-Mode View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-4
Limitations of L-Mode Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-5
Playback Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6
Calibration Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-7

Contents
iv
Adjust Playback Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-9
Bookmark Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-10
Setting Playback Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-11
Exporting a Recording or Still Frame . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-12
Capturing Still Images. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-12
Saving a Still Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-12
Printing Still Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-13
Printing a Still Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-13
Reviewing with Angio-Coregistration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-14
Measurements and Annotations
Measurements and Text Callouts in the Image Files. . . . . . . . . . . . . . . . . . . . . . . .7-1
Measurement and Annotation Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2
Verifying Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3
Techniques to Improve Measurement Accuracy. . . . . . . . . . . . . . . . . . . . . . . . . . .7-3
Measurements and Annotations in the L-Mode View . . . . . . . . . . . . . . . . . .7-3
Length Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-4
Making a Length (Distance) Measurement . . . . . . . . . . . . . . . . . . . . . . . . . .7-5
Area Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6
Making a Manual Area Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6
Adding Text Callouts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-8
Adding Text Callouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-9
The %AS Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-10
Formula for %AS Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-10
Make a %AS Calculation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-10
The %DS Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-12
Formula for %DS Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-12
Make a %DS Calculation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-12
Field of View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-14
Increase/Decrease Field of View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-14
Zooming In Manually. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-15
Quick Zoom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-16
Editing Measurements and Annotations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-17
Moving Individual Points. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-18
Adding Points to a Multiple Point Area. . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-18

Contents
ILUMIEN OPTIS System
Instructions for Use v
Deleting Points from a Multiple Point Area. . . . . . . . . . . . . . . . . . . . . . . . . .7-18
Deleting Individual Measurements or Text Callouts . . . . . . . . . . . . . . . . . . .7-19
Deleting All Measurements and Text Callouts . . . . . . . . . . . . . . . . . . . . . . .7-19
Lumen Profile Display Option. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-20
Lumen Profile Display With MLA Controls Overview. . . . . . . . . . . . . . . . .7-21
3D Display Option. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-23
3D Tissue Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-24
3D Display with Lumen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-25
Limitations of 3D Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-26
Exporting, Importing, and Managing Files
Compatible Transfer Media and USB Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2
Optical Media. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2
USB Connected Media. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2
File Formats. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4
About Native (Raw OCT) Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4
About DICOM Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4
About Standard Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-5
Image Format and Size in Standard Formats. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-6
File Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-6
Standard File Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-6
Exporting Files During a Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-7
Exporting Files in Native (Raw) Format . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-8
Exporting Files in DICOM Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-10
Exporting Files in Standard Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-12
Exporting Files from the Patient Summary Menu. . . . . . . . . . . . . . . . . . . . . . . . . .8-14
Using Exported Standard Format Recordings. . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-16
St. Jude Medical DICOM Viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-16
Importing Files from a CD/DVD or USB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-20
Deleting Files. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-22
Deleting Files from the Patient Summary Menu . . . . . . . . . . . . . . . . . . . . . .8-22
Deleting Files from the Database Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-23
Transfer and Import Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-24
Duplicate File Name Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-26
Database Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-26
Importing Patient Information From a DICOM Worklist or Storage Server.8-27

Contents
vi
Cleaning & Maintenance
Contacting St. Jude Medical Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2
Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2
Routine Cleaning Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-3
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-4
Optical Connection Cleaning Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5
Optical Adapter Replacement Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . .9-8
Cable Connection Inspection Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-10
Transferring Log Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-11
Identifying the Software Version. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-13
Infection Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-13
User Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-14
System Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-17
User Interface Reference
Setup Dialog Box and Submenus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1
Setup - Acquisition Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2
Setup - Acquisition/Other Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-4
Setup - Administration Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-5
Setup - Database Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-7
Setup - Database/Maintenance Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-9
Setup - Database/Physician Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-11
Setup - DICOM Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-12
Setup - DICOM/Image Options Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-17
Setup - DICOM/Local Host Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-19
Setup - Display Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-21
Setup - Measurements Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-23
Setup - Measurements/Labels Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-24
Setup - Print Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-25
Setup - Service Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-26
Setup - Service/System Diagnostics Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-29

Contents
ILUMIEN OPTIS System
Instructions for Use vii
Safety Information
Patient Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-2
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-2
Techniques to Minimize Patient Exposure. . . . . . . . . . . . . . . . . . . . . . . . . .11-2
Operator Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-3
Avoiding Operator Light Emission Hazards . . . . . . . . . . . . . . . . . . . . . . . .11-3
Repetitive Strain Injury (RSI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-3
Moving the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-4
Avoiding Electrical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-5
Making Proper Electrical Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-6
Explosion Hazard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-7
System Imaging Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-7
Considerations for Optimal Vessel Imaging . . . . . . . . . . . . . . . . . . . . . . . .11-7
Considerations for Optimal Tissue Imaging . . . . . . . . . . . . . . . . . . . . . . . .11-7
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-8
Electromagnetic Interference. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-8
Safety Functions Built Into the Ilumien Optis System . . . . . . . . . . . . . . . . . . . . .11-9
System Specifications
System - Safety & Regulatory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-1
System - Electrical and Physical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-3
Imaging Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-4
FFR Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-5
Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-6
Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-7
Recommended Separation Distances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-11
FCC Statement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-12
Essential Performance Defined by Operating Mode . . . . . . . . . . . . . . . . . .12-12
Index

Contents
viii

ILUMIEN OPTIS System
Instructions for Use i
Figures
1-1 Optis Integrated System Cabinet and Control Room Components . . . . . . . .1-4
1-1 Optis Integrated System Mobile Workstation . . . . . . . . . . . . . . . . . . . . . . . .1-5
1-2 Wi-Box in cathlab configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-11
2-1 Startup Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
2-2 Shutdown Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
3-1 Select Patient Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
3-2 Default Patient Alert. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
3-3 Patient Summary Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
3-4 Add New Patient Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
3-5 Edit Patient Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8
3-6 Case Information Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9
3-7 Recording as shown in the Patient Summary Menu. . . . . . . . . . . . . . . . . . . .3-11
3-8 OCT Review Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12
4-1 Cathlab with FFR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1
4-2 Room Manager: Enter Room Information . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
4-3 Set AO transducer height and open AO transducer guidance message . . . . .4-6
4-4 Flush PressureWire guidance message. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
4-5 Turn on PressureWire guidance message. . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8
4-6 Advance PressureWire and Equalize guidance message . . . . . . . . . . . . . . . .4-9
4-7 Pd/Pa waveforms equalizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11
4-8 Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12
5-1 DOC Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6
5-2 Purge Catheter guidance message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9
5-3 Plug Catheter into DOC Guidance Message . . . . . . . . . . . . . . . . . . . . . . . . .5-10
5-4 Dragonfly Catheter Connected to the DOC . . . . . . . . . . . . . . . . . . . . . . . . . .5-10
5-5 Catheter Connected, Initial Calibration done. . . . . . . . . . . . . . . . . . . . . . . . .5-11
5-6 OCT Settings Menu (during Recording) . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-12
5-7 Incorrect and Correct Calibration (Dragonfly Duo shown
in fingertips)5-14
5-8 Incorrect and Correct Calibration (Dragonfly OPTIS shown in fingertips). .5-14
5-9 System Display - Acquisition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-16
5-10 Catheter Failure message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-20
5-11 Safe Unload Guidance, Screen 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-21
5-12 Safe Unload Guidance, Screen 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-21

Figures
ii
5-13 Safe Unload Guidance, Screen 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-22
6-1 Playback Calibration (DragonFly Duo shown, in progress) . . . . . . . . . . . . .6-7
6-2 Field of View Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-9
6-3 Adjusted Playback Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-11
6-4 Angio-Coregistration Thumbnail Image . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-14
6-5 View Menu, Angio Co-Registration Button. . . . . . . . . . . . . . . . . . . . . . . . . .6-15
6-6 Angio Co-Registration: Register . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-16
6-7 Angio Co-Registration Guidance, Step 1. . . . . . . . . . . . . . . . . . . . . . . . . . . .6-16
6-8 Angio Co-Registration Guidance, Step 2. . . . . . . . . . . . . . . . . . . . . . . . . . . .6-17
6-9 Angio Co-Registration Guidance, Step 2 with Trace. . . . . . . . . . . . . . . . . . .6-18
6-10 Angio Co-Registration Guidance, Step 3. . . . . . . . . . . . . . . . . . . . . . . . . . . .6-19
6-11 Angio Co-registration completed successfully screen . . . . . . . . . . . . . . . . . .6-20
6-12 Main Screen showing Angio Co-Registration . . . . . . . . . . . . . . . . . . . . . . . .6-20
7-1 Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2
7-2 Length Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-4
7-3 Manual Area Measurement (in progress). . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6
7-4 Text Callouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-8
7-5 Enter Note Dialog Box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-9
7-6 Select Area Measurement Dialog Box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-10
7-7 %AS Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-11
7-8 %AS Error Message. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-11
7-9 Select Length Measurement Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-12
7-10 %DS Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-13
7-11 Zooming an Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-15
7-12 Setup Menu, Display Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-16
7-13 3D Display with Lumen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-25
7-14 MLA Frames in 3D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-25
8-1 Export Button (OCT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-7
8-2 The Export Wizard - Step 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-8
8-3 Define Alternate Patient ID Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-8
8-4 Highlighted Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-14
8-5 St. Jude Medical DICOM Viewer - Image View. . . . . . . . . . . . . . . . . . . . . .8-16
8-6 St. Jude Medical DICOM Viewer - Attributes View. . . . . . . . . . . . . . . . . . .8-17
8-7 Import Database Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-20
8-8 Deletion Warning Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-23
8-9 Add Patient - Step 1 (Worklist) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-27
8-10 Add Patient - Step 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-28
8-11 Add Patient - Step 1 (Storage Server) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-30
9-1 Inserting Cleaner Into Optical Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-6
9-2 Inserting Cleaner Into Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-7
9-3 Proper Gripping of Adapter for Removal. . . . . . . . . . . . . . . . . . . . . . . . . . . .9-8
9-4 Alignment of Optical Adapter with Optical Carriage . . . . . . . . . . . . . . . . . .9-9
9-5 Transfer Event Log Files Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-11

Figures
ILUMIEN OPTIS System
Instructions for Use iii
9-6 System Startup Window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-13
10-1 Setup - Acquisition Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2
10-2 Setup - Acquisition/Other Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-4
10-3 Setup - Administration Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-5
10-4 Setup - Database Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-7
10-5 Setup - Database/Maintenance Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-9
10-6 Setup - Database/Physician Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-11
10-7 Setup - DICOM Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-13
10-8 Configure DICOM Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-14
10-9 Setup - DICOM/Image Options Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-17
10-10 Setup - DICOM/Local Host Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-19
10-11 Setup - Display Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-21
10-12 Setup - Measurements Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-23
10-13 Setup - Measurements/Labels Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-24
10-14 Setup - Print Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-25
10-15 Setup - Service Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-26
10-16 Setup - Service/System Diagnostics Menu . . . . . . . . . . . . . . . . . . . . . . . . .10-29
11-1 Connector Panel Laser Safety Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-3
11-2 Electrical Label. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-6

Figures
iv

ILUMIEN OPTIS System
Instructions for Use i
Tables
Front-1 Instructions for Use Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Front-iv
1-1 Symbols Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8
1-2 DOC Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
3-1 Select Patient Menu functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
3-2 Patient Summary Menu functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
4-1 FFR Review Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13
5-1 System Display Description - Acquisition. . . . . . . . . . . . . . . . . . . . . . . . . . .5-16
6-1 OCT Display Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2
6-2 L-Mode view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-4
6-3 Playback Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6
6-4 Bookmark Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-10
7-1 Measurement and Annotation Tool Functions. . . . . . . . . . . . . . . . . . . . . . . .7-2
7-2 MLA Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-21
7-3 Lumen Profile %AS and %DS Calculations . . . . . . . . . . . . . . . . . . . . . . . . .7-22
7-4 3D Tissue Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-24
8-1 Optical Media Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2
8-2 DICOM File Attributes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-18
8-3 Import Database Menu Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-21
8-4 Transfer Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-24
8-5 Duplicate File Name Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-26
9-1 User Troubleshooting Tips. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-14
10-1 Setup Dialog Box Common Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-1
10-2 Setup - Acquisition Menu Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2
10-3 Setup - Acquisition/Other Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . .10-4
10-4 Setup - Administration Menu Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-5
10-5 Setup - Database Menu Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-7
10-6 Setup - Database/Maintenance Menu Settings. . . . . . . . . . . . . . . . . . . . . . .10-9
10-7 Setup - Database/Physician Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-11
10-8 Setup - DICOM Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-13
10-9 Setup - Configure DICOM Menu Settings. . . . . . . . . . . . . . . . . . . . . . . . . .10-15

Tables
ii
10-10 Setup - DICOM/Image Options Menu Settings. . . . . . . . . . . . . . . . . . . . . .10-17
10-11 Setup - DICOM/Local Host Menu Settings. . . . . . . . . . . . . . . . . . . . . . . . .10-19
10-12 Setup - Display Menu Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-21
10-13 Setup - Measurements Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-23
10-14 Setup - Measurements/Labels Menu Settings . . . . . . . . . . . . . . . . . . . . . . .10-24
10-15 Setup - Print Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-25
10-16 Setup - Service Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-27
10-17 Setup - Service/System Diagnostics Menu Settings. . . . . . . . . . . . . . . . . . .10-29
12-1 System Safety & Regulatory Specifications . . . . . . . . . . . . . . . . . . . . . . . .12-1
12-2 System Electrical and Physical Specifications. . . . . . . . . . . . . . . . . . . . . . .12-3
12-3 Imaging Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-4
12-4 FFR Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-5
12-5 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions . .12-6
12-6 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity . .12-7
12-7 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity . .12-9
12-8 Recommended separation distances between portable and mobile RF communica-
tions equipment and the Ilumien Optis System12-11

ILUMIEN OPTIS System
Instructions for Use 1-1
System Overview 1
OPTIS Integrated System Features
Optical Coherence Tomography (OCT) is an imaging modality that uses fiber-optic tech-
nology. The OPTIS INTEGRATED System uses optical imaging catheters that emit
near-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 aortic
pressure, measured during hyperemia. It provides the maximal blood flow in the presence
of a stenosis as a fraction of the achievable blood flow that would exist in the hypothetical
situation 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 the
OPTIS INTEGRATED System is used in conjunction with the manufacturer's wireless distal
intracoronary pressure transducer and a proximal aortic pressure transducer.
The OPTIS Integrated System is built into the catheter lab so that OCT and FFR are
immediately available without the need to find, connect, position, and power-on a mobile
console. The system allows either the sterile operator or non sterile operator to control
system functions during image and FFR acquisition and review, and to view the OCT and
FFR 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 to
visualize the position of OCT image data on angiography images, tightening the linkage
between anatomical assessment with OCT and subsequent therapeutic actions.
CAUTION: Medical personnel who use the OPTIS INTEGRATED System must be
aware of the system’s limitations. Only trained operators can deter-
mine if use of the OPTIS INTEGRATED System is appropriate. Be sure
to read Chapter 11 “Safety Information”, before operating the OPTIS
INTEGRATED System for the first time.

System Overview
OPTIS Integrated System Components
St. Jude Medical
1-2 Part Number ARTUS100109403
OPTIS INTEGRATED System Components
The OPTIS INTEGRATED System includes the following components, integrated into a
catheter 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 of
other 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 the
customer. Making such modifications may interfere with correct operation
and 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 is
new 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.