LightLab Imaging C408650 RFID DOC User Manual Manual

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ILUMIEN™ OPTIS™ System
Instructions for Use
Information provided within this Document is subject to change without notice and although believed to
be accurate, St. Jude Medical, Inc. and its affiliated companies including without limitation, St. Jude Medical System AB (Sweden), assume no responsibility for any errors, omissions or inaccuracies.
©2013 St. Jude Medical, Inc. and its related companies. All rights reserved. Reproduction, adaptation,
or translation without prior permission is prohibited, except as allowed under copyright laws.
ILUMIEN OPTIS systems are subject to US Patent 8,325,419, GB, FR 0883793, DE 69738291.
ILUMIEN, OPTIS, ST. JUDE MEDICAL, LIGHTLAB IMAGING, GOLDEN IMAGE and the color gold are
registered or unregistered trademarks of St. Jude Medical, Inc. and its related companies.
ILUMIEN OPTIS systems enabled for FFR may also be subject to US Patent 6,565,514.
The ILUMIEN OPTIS 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
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem Belgium
+32 2 774 68 11
LightLab Imaging, Inc.
4 Robbins Road
Westford, MA 01886
USA
Phone:
Australian Sponsor:
St. Jude Medical Australia Pty Limited
17 Orion Rd.,
Lane Cove NSW 2066 Australia
+61 2 9936 1200
+1 800 544 1664 (US)
+1 651 490 4410 (Outside US)
www.sjm.com
Service E-mail: OCTservice@sjm.com
Part Number ARTUS100088927
ENGLISH
Printed in the U.S.A. 3 / 2013
CAUTION: Federal law restricts this device to sale by or on the order of a Physician licensed by
law of the state in which he practices to use or order the use of the device.
SAFETY INFORMATION
Please review this manual carefully before using your ILUMIEN OPTIS 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 ILUMIEN OPTIS 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 ILUMIEN OPTIS System in the presence of flammable anesthetics. Doing so could lead
to an explosion.
Visible and Invisible Laser Radiation
Do not stare into the beam or view the beam directly with optical instruments. Doing so may cause serious eye damage and hazardous radiation exposure.
Using These Instructions for Use
This manual describes the St. Jude Medical ILUMIEN OPTIS System. In it you will find:
•
Descriptions of system components and user interface.
•
Procedures for using the system for both Optical Coherence Tomography (OCT) and Fractional Flow Reserve Rate (FFR) procedures.
•
System safety and cleaning information.
•
System specifications.
ILUMIEN OPTIS System
Instructions for Use
iii
Conventions Used in These Instructions for Use
•
These abbreviations and shortened expressions are used throughout this manual.
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.
Double-click
Click the left mouse button twice in quick succession.
Select
Highlight a menu item with the mouse or the tab or arrow keys.
•
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: , , .
•
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 provided 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:
iv
Additionally, this manual does not provide detailed discussion of the system components, except as they are used with the ILUMIEN OPTIS System.
Contents
Figures
Tables
System Overview
Ilumien Optis System Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Ilumien Optis System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Ilumien Optis System Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Ilumien Optis System - Physician Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Ilumien Optis System - Operator Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Ilumien Optis System - Connector Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Ilumien Optis Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
The Drive-motor and Optical Controller (DOC) . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
The Wi-Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Indications for Use and Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Warnings (OCT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Precautions (OCT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Complications (OCT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Warnings and Precautions (FFR). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Connecting to External Equipment/Accessories . . . . . . . . . . . . . . . . . . . . . . 1-16
Mechanical Enclosure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Electrical. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Electronic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Aortic Reference Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
ILUMIEN OPTIS System
Instructions for Use
Contents
Pressure Averaging (Mean Setting) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Defibrillation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Shut Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
FFR Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Monitor Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Setting Monitor Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Setting Monitor Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Using an External Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Opening a Patient Record
Select Patient Menu (Home Menu) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Patient Summary Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Entering New Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Editing Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Editing Case Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Importing a Patient Database. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Opening a Saved Recording or Still Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Performing an FFR Procedure
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Required Material and Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Setting up the Ilumien Optis System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Setting up the Wi-Box with the Ilumien Optis System . . . . . . . . . . . . . . . . . . . . . . 4-3
Setting up the PressureWire. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
ii
Contents
Preparing to Record FFR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Recording FFR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Reviewing an FFR Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
PressureWire Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
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
Setting up the Ilumien Optis System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Setting up the DOC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Setting up the Dragonfly Imaging Catheter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Preparing to Acquire OCT Recordings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Confirm Recording Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Dragonfly Imaging Catheter Insertion and Positioning. . . . . . . . . . . . . . . . . . . . . . 5-11
Acquiring Patient Images. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Removing the Dragonfly Imaging Catheter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Troubleshooting OCT Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Immediately Stopping DOC Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Catheter Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19
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
Adjust Playback Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Bookmark Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
ILUMIEN OPTIS System
Instructions for Use
iii
Contents
Setting Playback Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Exporting a Recording or Still Frame . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Capturing Still Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Saving a Still Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Printing Still Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
Printing a Still Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
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
Editing Measurements and Annotations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16
Moving Individual Points. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17
Adding Points to a Multiple Point Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17
Deleting Points from a Multiple Point Area. . . . . . . . . . . . . . . . . . . . . . . . . . 7-17
Deleting Individual Measurements or Text Callouts . . . . . . . . . . . . . . . . . . . 7-18
Deleting All Measurements and Text Callouts . . . . . . . . . . . . . . . . . . . . . . . 7-18
Lumen Profile Display Option. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19
Lumen Profile Display With MLA Controls Overview. . . . . . . . . . . . . . . . . 7-20
iv
Contents
3D Display Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-22
3D Navigation Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-23
3D Display with Segmented Lumen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-24
Limitations of 3D Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-25
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
Importing Patient Information from a Remote DICOM Server . . . . . . . . . . . . . . . 8-22
Deleting Files. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-24
Deleting Files from the Patient Summary Menu . . . . . . . . . . . . . . . . . . . . . . 8-24
Deleting Files from the Database Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-25
Transfer and Import Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-26
Duplicate File Name Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-28
Database Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-28
Cleaning & Maintenance
Contacting St. Jude Medical Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
ILUMIEN OPTIS System
Instructions for Use
Contents
Routine Cleaning Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Optical Connection Cleaning Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Optical Adapter Replacement Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
Air Filter Maintenance Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
Setup - Database/Maintenance Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7
Setup - Database/Physician Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Setup - DICOM Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9
Setup - DICOM/Image Options Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11
Setup - DICOM/Local Host Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12
Setup - DICOM/Remote Host Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-13
Setup - Display Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-14
Setup - Display/3D Option Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15
Setup - FFR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-16
Setup - Measurements Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17
Setup - Measurements/Labels Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-18
Setup - Options Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-19
Setup - Print Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-20
Setup - Service Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-21
vi
Contents
Setup - Service/System Diagnostics Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-23
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
ILUMIEN OPTIS System
Instructions for Use
vii
Contents
Index
viii
Figures
1-1
1-2
1-3
1-4
Ilumien Optis System - Physician Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Ilumien Optis System - Operator Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Ilumien Optis System Connector Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Wi-Box in cathlab configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
2-1
2-2
2-3
Ilumien Power Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Startup Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Shutdown Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
3-1
3-2
3-3
3-4
3-5
3-6
3-7
4-1
4-2
4-3
4-4
4-5
4-6
4-7
4-8
4-9
5-1
5-2
5-3
5-4
5-5
5-6
5-7
5-8
5-9
5-10
Select Patient Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Default Patient Alert. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Patient Summary Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Add New Patient Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Edit Patient Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Case Information Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Recording as shown in the Patient Summary Menu. . . . . . . . . . . . . . . . . . . . 3-9
Cathlab with FFR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Enter Room Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Select Current Room message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Set AO transducer height and open AO transducer guidance message . . . . . 4-5
Flush PressureWire guidance message. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Turn on PressureWire guidance message. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Advance PressureWire and Equalize guidance message . . . . . . . . . . . . . . . . 4-8
Pd/Pa waveforms equalizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
DOC Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Purge Catheter guidance message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Plug Catheter into DOC guidance message . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Dragonfly Catheter Connected to the DOC . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Catheter Connected, Initial Calibration done . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
OCT Settings Menu (during Recording) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Incorrect and Correct Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
System Display - Acquisition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Catheter Failure message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19
Replace Catheter message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19
ILUMIEN OPTIS System
Instructions for Use
Figures
6-1
6-2
6-3
Playback Calibration (in progress) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Field of View Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Adjusted Playback Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
7-1
7-2
7-3
7-4
7-5
7-6
7-7
7-8
7-9
7-10
7-11
7-12
7-13
8-1
8-2
8-3
8-4
8-5
8-6
8-7
8-8
8-9
Measurement and Annotation Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Length Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Manual Area Measurement (in progress). . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Text Callouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
Enter Note Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Select Area Measurement Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
%AS Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
%AS Error Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
Select Length Measurement Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12
%DS Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
Zooming an Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15
3D Display with Segmented Lumen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-24
MLA Frames in 3D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-24
Export Button (OCT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
The Export Wizard - Step 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Define Alternate Patient ID Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Highlighted Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14
St. Jude Medical DICOM Viewer - Image View . . . . . . . . . . . . . . . . . . . . . . 8-16
St. Jude Medical DICOM Viewer - Attributes View . . . . . . . . . . . . . . . . . . . 8-17
Import Database Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-20
Import from Remote DICOM Store Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-22
Deletion Warning Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-25
9-1
9-2
9-3
9-4
9-5
9-6
10-1
10-2
10-3
10-4
10-5
10-6
10-7
10-8
10-9
10-10
10-11
10-12
Inserting Cleaner Into Optical Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Inserting Cleaner Into Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Proper Gripping of Adapter for Removal. . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
Alignment of Optical Adapter with Optical Carriage . . . . . . . . . . . . . . . . . . 9-9
Transfer Event Log Files Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11
System Startup Window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Setup - Acquisition Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Setup - Acquisition/Other Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Setup - Administration Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
Setup - Database Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
Setup - Database/Maintenance Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7
Setup - Database/Physician Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Setup - DICOM Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9
Setup - DICOM/Image Options Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11
Setup - DICOM/Local Host Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12
Setup - DICOM/Remote Host Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-13
Setup - Display Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-14
Setup - Display/3D Option Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15
ii
Figures
10-13
10-14
10-15
10-16
10-17
10-18
10-19
Setup - FFR Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-16
Setup - Measurements Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17
Setup - Measurements/Labels Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-18
Setup - Options Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-19
Setup - Print Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-20
Setup - Service Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-21
Setup - Service/System Diagnostics Menu . . . . . . . . . . . . . . . . . . . . . . . . . 10-23
11-1
11-2
Connector Panel Laser Safety Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Electrical Label. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6
ILUMIEN OPTIS System
Instructions for Use
iii
Figures
iv
Tables
Front-1
Instructions for Use Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Front-iv
1-1
1-2
3-1
3-2
5-1
6-1
6-2
6-3
6-4
Symbols Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
DOC Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Select Patient Menu functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Patient Summary Menu functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
System Display Description - Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
OCT Display Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
L-Mode views. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Playback Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Bookmark Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
7-1
7-2
7-3
7-4
Measurement and Annotation Tool Functions . . . . . . . . . . . . . . . . . . . . . . . . 7-2
MLA Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20
Lumen Profile %AS and %DS Calculations . . . . . . . . . . . . . . . . . . . . . . . . . 7-21
3D Navigation Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-23
8-1
8-2
8-3
8-4
8-5
Optical Media Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
DICOM File Attributes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18
Import Database Menu Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-21
Transfer Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-26
Duplicate File Name Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-28
9-1
10-1
10-2
10-3
10-4
10-5
10-6
10-7
10-8
10-9
10-10
10-11
User Troubleshooting Tips. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14
Setup Dialog Box Common Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Setup - Acquisition Menu Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Setup - Acquisition/Other Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Setup - Administration Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
Setup - Database Menu Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
Setup - Database/Maintenance Menu Settings. . . . . . . . . . . . . . . . . . . . . . . 10-7
Setup - Database/Physician Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Setup - DICOM Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10
Setup - DICOM/Image Options Menu Settings . . . . . . . . . . . . . . . . . . . . . . 10-11
Setup - DICOM/Local Host Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . 10-12
Setup - DICOM/Remote Host Menu Settings . . . . . . . . . . . . . . . . . . . . . . . 10-13
ILUMIEN OPTIS System
Instructions for Use
Tables
10-12
10-13
10-14
10-15
10-16
10-17
10-18
10-19
10-20
Setup - Display Menu Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-14
Setup - Display/3D Option Menu Settings. . . . . . . . . . . . . . . . . . . . . . . . . . 10-15
Setup - FFR Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-16
Setup - Measurements Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17
Setup - Measurements/Labels Menu Settings . . . . . . . . . . . . . . . . . . . . . . . 10-18
Setup - Options Menu Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-19
Setup - Print Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-20
Setup - Service Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-21
Setup - Service/System Diagnostics Menu Settings. . . . . . . . . . . . . . . . . . . 10-23
12-1
12-2
12-3
12-4
12-5
12-6
12-7
12-8
System Safety & Regulatory Specifications . . . . . . . . . . . . . . . . . . . . . . . . 12-1
System Electrical and Physical Specifications. . . . . . . . . . . . . . . . . . . . . . . 12-3
Imaging Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4
FFR Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions . . 12-6
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity . . 12-7
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity . . 12-9
Recommended separation distances between portable and mobile RF
communications equipment and the Ilumien Optis System . . . . . . . . . . . . . 12-11
ii
System Overview
ILUMIEN OPTIS System Features
Optical Coherence Tomography (OCT) is an imaging modality that uses fiber-optic technology. The ILUMIEN OPTIS System uses optical imaging catheters that emit near-infrared
light to produce high-resolution real-time images. The frequency and bandwidth characteristics of the near-infrared light used in these systems result in image resolution 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 determine if therapeutic intervention is indicated. This functionality is achieved when the
ILUMIEN OPTIS System is used in conjunction with the manufacturer's wireless distal
intracoronary pressure transducer and a proximal aortic pressure transducer.
NOTE:
Fractional Flow Reserve is an optional feature, and must be activated on
your system. See your St. Jude Medical service representative for more
information.
CAUTION: Medical personnel who use the ILUMIEN OPTIS System must be aware
of the system’s limitations. Only trained operators can determine if
use of the ILUMIEN OPTIS System is appropriate. Be sure to read
Chapter 11 “Safety Information”, before operating the ILUMIEN
OPTIS System for the first time.
ILUMIEN OPTIS System
Instructions for Use
1-1
System Overview
Ilumien Optis System Components
ILUMIEN OPTIS System Components
The ILUMIEN OPTIS System includes the following components, integrated into a mobile
cart:
•
An imaging engine.
•
Two monitors.
•
A Drive-motor and Optical Controller (DOC).
•
An isolation transformer.
•
Aortic pressure and PressureWire receivers.
•
A computer, a keyboard, and a mouse.1
•
A power cable.
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 ILUMIEN OPTIS System.
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 representative for more information.
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.
1-2
St. Jude Medical
Part Number ARTUS100088927
System Overview
Ilumien Optis System Components
ILUMIEN OPTIS System Accessories
•
PressureWire
•
Wi-Box
•
C7 Dragonfly™ imaging catheter or Dragonfly™ Duo imaging catheter
•
Sterile DOC Cover
NOTE:
See your sales representative for order numbers of accessories in your
market.
ILUMIEN OPTIS System
Instructions for Use
1-3
System Overview
Ilumien Optis System Components
ILUMIEN OPTIS System - Physician Side
Physician Monitor
DOC
Connector Panel
Power Cord Connector
Main Power Switch
Wheel Locks
Figure 1-1: ILUMIEN OPTIS System - Physician Side
1-4
St. Jude Medical
Part Number ARTUS100088927
System Overview
Ilumien Optis System Components
ILUMIEN OPTIS System - Operator Side
Operator Monitor
Keyboard
DOC
On/Standby
Button
CD/DVD Drive
Mouse
Chart Holder
Air Filter
Figure 1-2: ILUMIEN OPTIS System - Operator Side
ILUMIEN OPTIS System
Instructions for Use
1-5
System Overview
Ilumien Optis System Components
ILUMIEN OPTIS System - Connector Panel
Figure 1-3: ILUMIEN OPTIS System Connector Panel
1-6
St. Jude Medical
Part Number ARTUS100088927
System Overview
Ilumien Optis System Components
ILUMIEN OPTIS Symbols
Before using the system, read these Instructions for Use carefully, including the identification of symbols used on the equipment.
Table 1-1: Symbols Description
Equipotential 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.
CSA International testing laboratory
Laser hazard symbol - marks a device which produces visible and invisible
laser radiation.
VIDEO: For connecting an external video monitor.
1280 x 1024 pixel image. Any monitor being connected must be capable of
displaying that resolution. If the monitor is not automatically detected, see
“Using an External Monitor” on page 2-6 to configure the system.
NOTE: Only monitors with DVI or VGA inputs and cables are supported.
WARNING: If the monitor is being used in the patient vicinity, it must
use an isolated power source or it may compromise electrical isolation and cause patient injury.
ATTENTION!: consult accompanying documents.
NETWORK: For connecting to a remote DICOM Store 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 must
be port powered or it may compromise electrical isolation
and cause patient injury.
ILUMIEN OPTIS System
Instructions for Use
1-7
System Overview
Ilumien Optis System Components
Table 1-1: Symbols Description (continued)
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.
Temperature Range (Shipping label)
1060hPa
Atmospheric Range (Shipping label)
500hPa
Humidity Range (Shipping label)
WARNING: All connections to the ILUMIEN OPTIS System must be made through
the System Connector Panel. Making connections directly to internal
components of the system may bypass isolation features and compromise patient safety.
1-8
St. Jude Medical
Part Number ARTUS100088927
System Overview
The Drive-motor and Optical Controller (DOC)
The Drive-motor and Optical Controller (DOC)
The Drive-motor and Optical Controller (DOC) provides bed-side control of the most
important OCT imaging functions. Refer to “Preparing to Acquire OCT Recordings” on
page 5-6 for Dragonfly Imaging Catheter connection details.
Table 1-2: DOC Controls
Lock LED
Unload button
Live View button
Enable button
Stop button
Pullback Motion LEDs
Laser Emission Symbol
Lock 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 enable recording.
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 Emission Symbol
Illuminated when laser output is on (whenever the system is in Live scanning mode).
ILUMIEN OPTIS System
Instructions for Use
1-9
System Overview
The Wi-Box
The Wi-Box
The Wi-Box is installed in your cathlab between your Hemodynamic Recording System
and the AO Transducer. The position of the Wi-Box in a cathlab is shown in Figure 1-4.
PressureWire
AO pressure
transducer
Hemodynamic
recording
system
Wi-Box
Ilumien
Figure 1-4: Wi-Box in cathlab configuration
The wireless connection to your Wi-Box is made during setup for your procedure. See
“Setting up the Wi-Box with the Ilumien Optis System” on page 4-3 for more information.
1-10
St. Jude Medical
Part Number ARTUS100088927
System Overview
Indications for Use and Intended Use
Indications for Use and Intended Use
The ILUMIEN OPTIS Imaging System with Dragonfly Imaging Catheter is intended for the
imaging of coronary arteries and is indicated in patients who are candidates for
transluminal interventional procedures. The Dragonfly Imaging Catheter is intended for
use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly Imaging Catheter is not intended
for use in the left main coronary artery or in a target vessel which has undergone a
previous bypass procedure.
The ILUMIEN OPTIS Imaging System will further acquire radio frequency signal outputs
from both a distal intracoronary pressure transducer and a proximal aortic pressure
transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The
physician may use the FFR parameter, along with knowledge of patient history, medical
expertise and clinical judgment to determine if therapeutic intervention is indicated.
CAUTION: The ILUMIEN OPTIS System is intended for use by appropriate medical
personnel who have received ILUMIEN OPTIS training. St. Jude Medical and its employees cannot give instructions in the interpretation or
diagnosis of recordings and makes no attempt to do so.
WARNING: Prior to use, please review the Instructions for Use supplied with the
Dragonfly Imaging Catheter and with the PressureWire for more
information.
ILUMIEN OPTIS System
Instructions for Use
1-11
System Overview
Contraindications
Contraindications
Use of the St. Jude Medical ILUMIEN OPTIS System is contraindicated where introduction
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 failure
NOTE:
1-12
The system has no patient alarm functions. Do not use for cardiac monitoring.
St. Jude Medical
Part Number ARTUS100088927
System Overview
Warnings (OCT)
Warnings (OCT)
•
Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.
•
Observe all advancement and movement of the Dragonfly Imaging Catheter under
fluoroscopy. Always advance and withdraw the catheter slowly. Failure to observe
device movement fluoroscopically may result in vessel injury or device damage.
•
Leave the guidewire engaged with the catheter at all times during use. Do not withdraw or advance the guidewire prior to withdrawing the catheter.
•
If resistance is encountered during advancement or withdrawal of the Dragonfly
Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of
resistance cannot be determined or mitigated, carefully remove the catheter and
guidewire together.
•
The catheter should never be forced into lumens that are narrower than the catheter
body 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 guidewire, resulting in entrapment of catheter/guidewire, catheter tip separation, and/or
stent dislocation.
•
Refer to the contrast media’s instructions-for-use for general warnings and precautions relating to use of the contrast media.
CAUTION: Before creating an OCT recording, review Chapter 5 “Performing an
OCT Procedure” for additional warnings and cautions.
ILUMIEN OPTIS System
Instructions for Use
1-13
System Overview
Precautions (OCT)
Precautions (OCT)
1-14
•
Safety and effectiveness have been established for the following patient population:
adult patients undergoing non-emergent percutaneous coronary interventions in
lesions with reference vessel diameters between 2.0 to 3.5 mm, which were not
located in the left main coronary artery or in a target vessel which has undergone
previous bypass procedures.
•
All operators must be trained prior to using the ILUMIEN OPTIS System and the
Dragonfly 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 in
accordance with accepted medical practice and applicable laws and regulations.
•
The catheter has no user serviceable parts. Do not attempt to repair or alter any part
of the catheter assembly as provided.
St. Jude Medical
Part Number ARTUS100088927
System Overview
Complications (OCT)
Complications (OCT)
The risks involved in vascular imaging include those associated with all catheterization
procedures. The following complications (listed alphabetically) may occur as a consequence of intravascular imaging and may necessitate additional medical treatment including 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
ILUMIEN OPTIS System
Instructions for Use
1-15
System Overview
Warnings and Precautions (FFR)
Warnings and Precautions (FFR)
CAUTION: Before beginning an FFR procedure, review the PressureWire Instructions for Use. Details of the PressureWire are covered in the PressureWire Instructions for Use and are not covered in this manual.
CAUTION: Patients with potential microvascular dysfunction and borderline
FFR values should be interpreted with caution, and management
strategies should be guided not only by pressure measurement, but
also by possibly supplementary clinical risk stratification and other
tests.
Connecting to External Equipment/Accessories
WARNING: When used in the patient environment, all equipment connected to the ILUMIEN OPTIS 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 ILUMIEN OPTIS 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 ILUMIEN
OPTIS 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 ILUMIEN OPTIS System wireless receivers.
Mechanical Enclosure
WARNING: Do not use the ILUMIEN OPTIS 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.
Electrical
WARNING: 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 ILUMIEN OPTIS System. Conductive connection may cause leakage currents to induce ventricular
fibrillation. High frequency surgical equipment must not be used on a patient at the same time as PressureWire and the ILUMIEN OPTIS System.
Electronic Interference
CAUTION: Radio transmitting equipment, cellular phones and strong emission sources such as high frequency surgical equipment shall not be used in the close proximity of the ILUMIEN OPTIS System since this
could influence the performance of the device.
1-16
St. Jude Medical
Part Number ARTUS100088927
System Overview
Warnings and Precautions (FFR)
Aortic Reference Pressure
CAUTION: Check that the monitor cables and AO adapter delivered with the ILUMIEN OPTIS 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 ILUMIEN OPTIS System to calibrate the aortic
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 insensitive or overly sensitive mean average of pressure may result in an incorrect FFR value.
Defibrillation
CAUTION: The ILUMIEN OPTIS 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 PressureWire after defibrillation use.
Recording
CAUTION: 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 an
FFR Procedure” for additional warnings and cautions.
CAUTION: After use, the catheter may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable
laws and regulations.
ILUMIEN OPTIS System
Instructions for Use
1-17
System Overview
Warnings and Precautions (FFR)
1-18
St. Jude Medical
Part Number ARTUS100088927
System Setup
Positioning the System
WARNING: Failure to position the system as described may lead to a system tipping hazard or a pinching hazard, causing possible patient or operator injury and damage to the system.
•
Position the ILUMIEN OPTIS System at the foot of the patient table with the Physician Monitor facing the attending physician.
The ILUMIEN OPTIS System may be placed at other locations, however care must be
taken to ensure the system is clear of any moving equipment, including the angiography system. It is the responsibility of the attending physician to ensure that collisions do not occur.
NOTE:
Whenever the ILUMIEN OPTIS System is used near moving equipment, it is recommended that the wheels remain unlocked to allow
the system to roll if it is bumped.
•
Ensure the power cord and any other connections to the ILUMIEN OPTIS System are
routed to prevent a tripping hazard. Ensure that the main power switch and power
plug can be accessed at any time during the procedure.
•
Ensure that the ILUMIEN OPTIS System is positioned so the connection between the
console and the DOC will not be disturbed during use.
ILUMIEN OPTIS System
Instructions for Use
2-1
System Setup
Connecting Your System
Connecting Your System
System Connections
To connect the system to power, refer to Figure 2-1 for the power connector location:
Power Cord Connector
Main Power Switch
Figure 2-1: ILUMIEN Power Connection
Powering On and Shutting Down Your System
Make sure the power cord is connected to the system and is plugged into a grounded electrical outlet. Secure the power cord using the strain-relief clip on the Power Cord Connector. For detailed information on electrical requirements, see “Making Proper Electrical
Connections” on page 11-6.
WARNING: Never use a converter adapter to plug the three-pronged AC plug into
a two-pronged, ungrounded wall outlet. Doing so may result in electric
shock to the patient or operator and damage to equipment.
2-2
St. Jude Medical
Part Number ARTUS100088927
System Setup
Powering On and Shutting Down Your System
Power On
To power on your system:
1.
Press the main power switch at the base of the cart to turn on system power (see Figure 1-1 on page 1-4).
2.
Confirm that both monitors are powered by observing that the appropriate power
indicator is lit. See “Monitor Setup” on page 2-6 for details.
3.
Press the On/Standby button located in the upper right corner of the keyboard tray
(see Figure 1-2 on page 1-5) to start the system. The system's Startup screen appears
(Figure 2-2).
Figure 2-2: Startup Screen
NOTE:
Once the system is turned on and the System Display is being shown, you
may need to adjust the monitor’s brightness and contrast as described in
“Monitor Setup” on page 2-6.
ILUMIEN OPTIS System
Instructions for Use
2-3
System Setup
Powering On and Shutting Down Your System
Shut Down
CAUTION: Do not unplug from AC power or turn off main power until the shutdown is complete, the screens turn black, and the green monitor LEDs
turn amber. Disconnecting from AC power before the shutdown is
complete may damage the system.
NOTE:
Use the Shutdown button at the top of the screen to shut down the system.
Use of the On/Standby key 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 Shutdown
menu appears (Figure 2-3).
Figure 2-3: Shutdown Menu
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, the
screens turn black, the green monitor LEDs turn amber, and the system enters
standby mode.
2-4
3.
After the screens turn black and the green monitor LEDs turn amber, press the main
power switch at the base of the cart to turn off system power.
4.
If necessary, disconnect the power cord from AC power.
St. Jude Medical
Part Number ARTUS100088927
System Setup
FFR Settings
FFR Settings
NOTE:
1.
To access the full FFR Settings menu, you must be in the process of making an FFR recording, and have selected a room for the FFR procedure.
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 detail
visible to the user. A high number is suitable when a detailed picture of the
tracings is required. A low number is suitable when displaying slow changes,
for instance during intravenous infusing and pullback. The default setting is
Normal.
•
Mean Filter Length (Beats): Changes the time over which the mean pressure value is calculated. The adjustments are made by selecting the mean calculation filter length, measured in number of heartbeats. The default setting is
3 heartbeats.
CAUTION: Choosing a high number of heartbeats makes the pressure
averaging slower and less sensitive to artifacts, but may
also result in overly insensitive averaging which is noticeable when there is a short hyperaemic plateau. Choosing a
low number of heartbeats makes the pressure averaging
faster and more sensitive to pressure changes, desirable
using a short hyperaemic plateau, but it may also result in
an averaging overly sensitive to arrhythmia and pressure
disturbances.
NOTE:
ILUMIEN OPTIS System
Instructions for Use
An insensitive or overly sensitive averaging of pressure may
result in an incorrect FFR value.
Changes in the Mean Filter Length setting are not applied to
previous FFR recordings.
When a new patient is selected, the Mean Filter Length setting is reset to 3 heartbeats.
2-5
System Setup
Monitor Setup
Monitor Setup
The 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 Functions
Refer to the Instructions for Use that accompanied your monitor.
Setting Monitor Position
The angle of the flat panel monitor should be set to eliminate or minimize glare from surrounding 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.
Using an External Monitor
An external monitor such as a ceiling mounted display or a projector may be connected to
the System through the Video connector on the System Connector Panel. DVI monitors
are automatically detected. However, VGA monitors are not detected automatically and
must be enabled. For VGA monitors:
1.
Click the Settings button to open the Setup dialog box.
2.
Click the Service button to open the Service menu.
3.
Click the Enable button in the External Monitor section.
The external monitor shows the System Display within a few seconds.
NOTE:
2-6
If the Enable button in the External Monitor section is inactive
(dimmed), contact St. Jude Medical to have this option enabled.
St. Jude Medical
Part Number ARTUS100088927
Opening a Patient Record
CAUTION: Please note St. Jude Medical makes no representation or warranty
that use of the ILUMIEN OPTIS System complies with applicable privacy, security and confidentiality laws, but encourages you to assess
your own risk as you use, disclose, control, process or transfer patient
health information with the ILUMIEN OPTIS System.
ILUMIEN OPTIS System
Instructions for Use
3-1
Opening a Patient Record
Select Patient Menu (Home Menu)
Select Patient Menu (Home Menu)
When the system is first started, the Select Patient menu is displayed (Figure 3-1). From
this menu, you can enter a new patient in the database, open an existing patient, or import
a previous patient record.
Figure 3-1: Select Patient Menu
Table 3-1: Select Patient Menu functions
3-2
Search button: Enter a term and click this button to search the patient database.
Export button: Click this button to open the Export Wizard.
Import button: Click this button to open the Import menu.
Add New Patient button: Click this button to enter a new patient into the System database.
OK button: Select a patient and click this button to open the Patient Summary menu
for that patient.
List of all existing patients in the system database. Click on a column header to
sort the patients according to data in that column.
St. Jude Medical
Part Number ARTUS100088927
Opening a Patient Record
Select Patient Menu (Home Menu)
WARNING: 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 patient
to store patient images. Click OK to continue to use the default
patient, or Cancel to return to the Select Patient menu to select
another patient.
Figure 3-2: Default Patient Alert
ILUMIEN OPTIS System
Instructions for Use
3-3
Opening a Patient Record
Patient Summary Menu
Patient Summary Menu
When 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.
Figure 3-3: Patient Summary Menu
Table 3-2: Patient Summary Menu functions
Patient information, including name, ID, date of birth, and gender.
Dates of recordings for this patient. The list is sorted by date, with the most recent recordings
at the top.
Gallery 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.
Delete : Check one or more recordings to select them, and click the Delete button to delete
them.
Export : Check one or more recordings to select them, and click the Export button to open the
Export Wizard.
Edit Patient : Click this button to edit patient information.
Edit Case : Click this button to edit case information.
New OCT Recording / New FFR Recording : Use these buttons to begin a new recording for
this patient.
Home button: Press to return to the Select Patient menu.
3-4
St. Jude Medical
Part Number ARTUS100088927
Opening a Patient Record
Entering New Patient Information
Entering New Patient Information
You can enter a new patient from the Select Patient menu.
1.
In the Select Patient menu, click the Add new patient button.
The Add new patient menu opens (see Figure 3-4).
Figure 3-4: Add New Patient Menu
2.
Enter the patient information as needed.
NOTE:
3.
You must enter Patient ID, First name, and Last name before you
can save the patient information.
Click New OCT Recording to save the changes and begin a new OCT recording
for this patient, click New FFR Recording to save changes and begin a new FFR
recording for this patient, or Cancel to close the menu without saving and return to
the Select Patient menu.
ILUMIEN OPTIS System
Instructions for Use
3-5
Opening a Patient Record
Editing Patient Information
Editing Patient Information
The patient information can be edited from the Patient Summary menu.
1.
In the Select Patient menu, click on the patient and then click OK.
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).
Figure 3-5: Edit Patient Menu
3.
Edit the patient information as needed.
NOTE:
4.
3-6
You must enter Patient ID, First name, and Last name before you
can save the patient information.
Click OK to save the changes, or Cancel to close the menu without saving.
St. Jude Medical
Part Number ARTUS100088927
Opening a Patient Record
Editing Case Information
Editing Case Information
The physician name and accession number for a case can be edited from the Patient
Summary menu.
1.
In the Select Patient menu, click on the patient and then click OK.
The Patient Summary menu for that patient opens (see Figure 3-3).
2.
Click on a case to select it.
NOTE:
3.
In the ILUMIEN OPTIS System, all recordings and still images from
the same date use the same physician and accession number.
Click the Edit Case button.
The Case Information menu opens (see Figure 3-6).
Figure 3-6: Case Information Menu
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.
ILUMIEN OPTIS System
Instructions for Use
3-7
Opening a Patient Record
Importing a Patient Database
Importing a Patient Database
Previous C7 XR, ILUMIEN, and ILUMIEN OPTIS OCT and FFR recordings can be imported
into the system using the Import button on the Select Patient menu. For more information on importing patient files or information, see “Importing Files from a CD/DVD or
USB” on page 8-20.
3-8
St. Jude Medical
Part Number ARTUS100088927
Opening a Patient Record
Opening a Saved Recording or Still Image
Opening a Saved Recording or Still Image
Each recording or still image has an entry in the Patient Summary menu. The entry
includes a timestamp and a thumbnail, and can display the Vessel, Procedure, and a
Comment, if added. The thumbnail adds icons to represent the status and content of the
file:
•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, double-click on a patient’s name, or select a
patient name and click OK.
•
From an OCT or FFR recording, click on the Patient Summary button at the
top 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.
Figure 3-7: Recording as shown in the Patient Summary Menu
The recording or still image opens. Recordings play automatically.
•
To navigate an OCT recording, see “Playback Controls” on page 6-6; to navigate an FFR recording, see “Reviewing an FFR Recording” on page 4-12.
•
To add measurements and annotations to the OCT recording or still frame, see
Chapter 7 “Measurements and Annotations”.
•
To export the entire OCT recording or individual frames, see Chapter 8
“Exporting, Importing, and Managing Files”.
ILUMIEN OPTIS System
Instructions for Use
3-9
Opening a Patient Record
Opening a Saved Recording or Still Image
4.
3-10
To end the review and return to the Patient Summary menu, click the End Review
button.
St. Jude Medical
Part Number ARTUS100088927
Performing an FFR Procedure
Overview
The FFR procedure requires two operators; a sterile operator and a non-sterile operator.
All steps requiring contact with the PressureWire must be performed by the sterile operator. All steps performed in direct contact with the ILUMIEN OPTIS System must be performed by the non-sterile operator.
A typical cathlab configured for FFR is shown below.
PressureWire
AO pressure
transducer
Wi-Box
Hemodynamic
recording
system
Ilumien
Figure 4-1: Cathlab with FFR
Required Material and Equipment
•
ILUMIEN OPTIS System
•
PressureWire
•
Wi-Box, installed in each room where the ILUMIEN OPTIS System is to be used to
measure FFR
•
Heparinized, physiologic saline solution, for hydrophilic catheter preparation
ILUMIEN OPTIS System
Instructions for Use
4-1
Performing an FFR Procedure
Setting up the Ilumien Optis System
Setting up the ILUMIEN OPTIS System
4-2
1.
Position the system for use. See “Positioning the System” on page 2-1.
2.
Turn on the system. See “Power On” on page 2-3.
St. Jude Medical
Part Number ARTUS100088927
Performing an FFR Procedure
Setting up the Wi-Box with the Ilumien Optis System
Setting up the Wi-Box with the ILUMIEN OPTIS System
The Wi-Box should be connected to your facility’s Hemodynamic Recording System at
installation. The first time the ILUMIEN OPTIS System is connected to a Wi-Box, the room
appears as Unknown, and must be given a unique name and number. Click on the room
and enter a Room Name and Room Number. Press OK when finished.
Figure 4-2: Enter Room Information
Refer to the installation instructions that came with your Wi-Box for further information.
Setting up the PressureWire
WARNING: Please review the Instructions for Use supplied with the PressureWire
for a complete list of warnings, cautions, and setup instructions.
ILUMIEN OPTIS System
Instructions for Use
4-3
Performing an FFR Procedure
Preparing to Record FFR
Preparing to Record FFR
WARNING: The heart rate and mean pressure values shown on the ILUMIEN OPTIS
System are for reference only and are not intended to be used as the
primary display.
Start FFR recordings from the Patient Summary menu.
1.
If necessary, enter the patient’s information. See “Entering New Patient Information” on page 3-5.
NOTE:
2.
Patient information should be entered into the system and selected
for 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, and
continue with Step 4 in this section.
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.
The screen displays all rooms with an active Wi-Box within range of the system,
and the guidance message “Select the current room.”
Figure 4-3: Select Current Room message
4-4
St. Jude Medical
Part Number ARTUS100088927
Performing an FFR Procedure
Preparing to Record FFR
4.
Click on the current room to select it.
CAUTION: In order to connect to the correct AO source (Wi-Box) you must
select the room where the system is being used.
The first time you connect to a room, you must enter the room’s
information into the system. See “Setting up the Wi-Box with the
Ilumien Optis System” on page 4-3 for more information.
The screen displays the main screen with the guidance message “Set AO transducer
height to heart level, then open AO transducer to air. Click Zero Pa.”
Figure 4-4: Set AO transducer height and open AO transducer guidance message
5.
Position the AO transducer so that it is level with the patient’s heart.
NOTE:
6.
The AO transducer should remain level with the patient’s heart throughout
the procedure.
Open the AO transducer to air.
ILUMIEN OPTIS System
Instructions for Use
4-5
Performing an FFR Procedure
Preparing to Record FFR
7.
In the Pa measurement box, click the Zero button.
Figure 4-5: Flush PressureWire guidance message
8.
Close the AO transducer.
9.
Prepare the PressureWire in accordance with the PressureWire Instructions for Use
and the on screen prompts.
CAUTION: Do not use the PressureWire if there are any signs of damage.
10.
In the Pd measurement box, click the Connect button.
NOTE:
4-6
You have 60 seconds to make the connection between the PressureWire transmitter and the system.
St. Jude Medical
Part Number ARTUS100088927
Performing an FFR Procedure
Preparing to Record FFR
The system is now looking for a PressureWire. The Pd measurement box shows the
message “Searching.”
Figure 4-6: Turn on PressureWire guidance message
CAUTION: Do not turn on more than one PressureWire while the system is
Searching/Connecting.
11.
Turn on the PressureWire transmitter.
The Pd measurement box shows the message “Connecting” as the PressureWire
transmitter and the system make the wireless connection. Once the connection is
established, 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, the
message in the Pd measurement box changes back to “No Sensor.”
Turn off the PressureWire and return to Step 10.
12.
Remove the PressureWire from the plastic hoop.
13.
Insert the PressureWire into the patient in accordance with the PressureWire
Instructions for Use.
ILUMIEN OPTIS System
Instructions for Use
4-7
Performing an FFR Procedure
Preparing to Record FFR
The pressure from the AO transducer and PressureWire must now be equalized.
Figure 4-7: Advance PressureWire and Equalize guidance message
CAUTION: If the PressureWire is turned off or loses power at any point
after equalization, you must remove it from the patient and
re-zero it in its plastic hoop in heparinized saline before continuing. See the PressureWire Instructions for Use for more information on troubleshooting the PressureWire.
4-8
St. Jude Medical
Part Number ARTUS100088927
Performing an FFR Procedure
Preparing to Record FFR
14.
Check the pressures displayed in the Pa and Pd measurement boxes. If the pressures
are not equal, click the Equalize button to equalize the pressure reading between
the AO transducer and the PressureWire.
The equalization offset value appears in the Equalization measurement box. The
offset is applied to the Pd pressure, to match the value of the Pa pressure.
CAUTION: If the equalization offset value is greater than or
equal to 10, or equal to or lower than -10, the system displays an alert icon in the Equalization
measurement box. If the system displays this alert
icon, try the following to reduce the EQ value:
•
Confirm the AO transducer is positioned at the same height
as the patient's heart and re-equalize.
•
If the alert remains, remove the PressureWire from the
patient and re-zero it in its plastic hoop in heparinized saline.
CAUTION: To prevent incorrect measurement of the aortic pressure by the
guiding catheter, causing an incorrect FFR (Pd/Pa) calculation:
NOTE:
ILUMIEN OPTIS System
Instructions for Use
•
Flush any contrast remnants from the guide catheter with
heparinized saline.
•
The insertion tool must be pulled back out of the hemostatic
valve.
•
The hemostatic valve must be closed during pressure measurement.
The equalization value (EQ) is reset when Pa or Pd is zeroed, or
when the PressureWire is restarted (turned on/off).
4-9
Performing an FFR Procedure
Recording FFR
Recording FFR
1.
Confirm that the FFR settings are correct for the current procedure. See “FFR Settings” on page 2-5 for more information.
2.
With the PressureWire in position and equalized, advance it across the area to be
examined.
The bottom of the graphical area shows the Pd/Pa waveform, along with the Pd/Pa
ratio.
Figure 4-8: Pd/Pa waveforms equalizing
4-10
3.
Induce hyperemia according to standard cathlab procedures.
4.
Click the Record button.
St. Jude Medical
Part Number ARTUS100088927
Performing an FFR Procedure
Recording FFR
A recording timer is displayed at the bottom of the screen. Click the Mark button
to mark an instant on the recording for later review. A mark appears as a vertical
white line on the recording.
Figure 4-9: Recording
5.
Record pressure until steady state maximum hyperaemic condition is reached, until
the hyperaemic effect begins to decrease, or until the physician decides to end the
recording. When finished, click the Stop button to end the recording.
CAUTION: When the procedure is complete, handle the PressureWire and all
other disposables used during the procedure as potential biohazards.
Dispose of in accordance with accepted medical practice and all applicable laws and regulations.
ILUMIEN OPTIS System
Instructions for Use
4-11
Performing an FFR Procedure
Reviewing an FFR Recording
Reviewing an FFR Recording
When 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 to
abnormal heartbeats or artifacts in AO (Pa) caused by flushing of
guiding catheter or valve opening/closing. The physician should
always confirm that the point selected by the system is a valid point for
the calculation of FFR.
CAUTION: If you have zoomed in on a section of the recording, portions of the
waveform are not displayed (the recording extends off screen). The
physician should always review the entire unzoomed recording before
selecting the point for the calculation of FFR.
4-12
St. Jude Medical
Part Number ARTUS100088927
Performing an FFR Procedure
Reviewing an FFR Recording
Patient name and ID.
See “Entering New Patient Information” on page 3-5 for more information.
Patient Summary button: Click to open a list of all recordings for this patient.
See “Patient Summary Menu” on page 3-4 for more information.
Recording date and time.
Export button: Click to open the Export Wizard.
See Chapter 8 “Exporting, Importing, and Managing Files” for more information.
Print button: Available when a USB drive is connected. Click to print the FFR recording.
Settings button: Click to open the FFR Settings menu.
See “FFR Settings” on page 2-5 for more information.
Pa measurement box. Mean Pa value at the cursor is displayed.
Pd measurement box. Mean Pd value at the cursor is displayed.
The FFR value at the cursor.
End 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 New Recording
appears here. Click the New Recording button to close this review and begin a new
FFR recording.
CAUTION: When closing the recording, the current cursor position and corresponding FFR value is saved. When the recording is re-opened, the cursor
appears at the saved position. The cursor may then be moved, and the displayed Pa and Pd pressures and FFR value change to reflect the new cursor position.
Zoom in/Zoom out of the recording, centered on the cursor.
Procedure list: Click to open a drop-down list of procedures to describe this recording.
Vessel list: Click to open a drop-down list of vessels to describe this recording.
Move the cursor to read the Pa, Pd, and FFR value at any point in the recording.
FFR waveform
Pa and Pd pressure waveforms
ILUMIEN OPTIS System
Instructions for Use
4-13
Performing an FFR Procedure
PressureWire Troubleshooting
PressureWire Troubleshooting
In case of low power in the PressureWire, the light on the PressureWire
unit flashes yellow, and a low battery indicator appears in the Pd measurement box.
If there is a problem with your PressureWire, refer to the PressureWire
Instructions for Use for details.
4-14
St. Jude Medical
Part Number ARTUS100088927
Performing an OCT Procedure
Overview
The 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 sterile DOC cover must be performed by the sterile operator. All steps performed within the
sterile DOC cover or in direct contact with the ILUMIEN OPTIS System must be performed
by the non-sterile operator.
Required Material and Equipment
•
ILUMIEN OPTIS System
•
C7 Dragonfly Imaging Catheter or Dragonfly Duo Imaging Catheter
•
Sterile DOC Cover
•
3 mL purge syringe
•
Contrast media indicated for coronary use, for purging and flush (allow 15 mL for
each 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 of
injecting 4.0 mL /sec for a total of 14 mL in 3.5 seconds)
ILUMIEN OPTIS System
Instructions for Use
5-1
Performing an OCT Procedure
Overview
OCT Imaging Overview
1.
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 mL
syringe.
3.
Puff - Inject a small amount (~ 4 mL) of contrast through the guide catheter to evaluate 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:
5-2
In the left coronary system, guide catheter placement and orientation is
key to achieving good contrast flow. This is particularly true in the LCX.
St. Jude Medical
Part Number ARTUS100088927
Performing an OCT Procedure
OCT Operating Modes
OCT Operating Modes
During acquisition, the system is divided into Standby View and Live View.
•
Standby View - The DOC is not rotating the imaging catheter. The last image
viewed through the catheter lens is shown on the display.
•
Live View - The DOC is rotating the imaging catheter at low-speed, and is transmitting images from the catheter lens to the display.
After the image has been recorded, see Chapter 6 “Reviewing OCT Recordings” for more
information on reviewing OCT recordings.
OCT Recording Types
The system can make two types of recordings: Pullback and Stationary. See “Setup Acquisition Menu” on page 10-2 for more information.
NOTE:
The instructions in this manual are for Pullback recordings. Differences
for Stationary recordings are noted where applicable.
Setting up the ILUMIEN OPTIS System
1.
Position the system for use. See “Positioning the System” on page 2-1.
2.
Turn on the system. See “Power On” on page 2-3.
ILUMIEN OPTIS System
Instructions for Use
5-3
Performing an OCT Procedure
Setting up the DOC
Setting up the DOC
The 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.
Sterile Field
Non-sterile Field
3 mL Syringe
Contrast Purge
From
Contrast Source
Contrast Injection Line
Manifold
Patient
Guide
Catheter
DOC
Guidewire
DOC
Cable
Dragonfly
Imaging Catheter
To ILUMIEN
OPTIS
System
Figure 5-1: DOC Connections
Non-sterile Operator
1.
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 Operator
3.
Connect the flush media (syringe or automated injector) to one port of the guide
catheter manifold (see Figure 5-1).
4.
Use the following settings to prepare for flush delivery:
5.
5-4
•
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 available
setting.
Purge all air from the tubing and manifold following standard practice.
St. Jude Medical
Part Number ARTUS100088927
Performing an OCT Procedure
Setting up the Dragonfly Imaging Catheter
Setting up the Dragonfly Imaging Catheter
WARNING: Prior to use, please review the Instructions for Use supplied with the
Dragonfly Imaging Catheter for more information.
1.
Inspect the packaging of the catheter for damage.
CAUTION: Do not use the catheter if the sterile packaging is compromised.
2.
Using sterile technique, carefully remove the Dragonfly catheter from its sterile
package.
3.
Carefully remove the catheter from the plastic hoop and examine it for visible damage 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 cm
proximally using heparinized saline to ensure optimal performance of the hydrophilic 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 the
fiber-optics within the catheter. Kinking and bending of the
catheter can cause damage.
ILUMIEN OPTIS System
Instructions for Use
5-5
Performing an OCT Procedure
Preparing to Acquire OCT Recordings
Preparing to Acquire OCT Recordings
New OCT recordings are started from the Patient Summary menu.
1.
If necessary, enter the patient’s information. See “Entering New Patient Information” on page 3-5.
NOTE:
2.
Patient information should be entered into the system and selected
for use before beginning a recording.
If you are entering a patient through the Add New Patient menu,
click the New OCT Recording button at the bottom of the menu,
and continue with Step 4 below.
In the Select Patient menu, click on the patient and then click OK.
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:
4.
If necessary, enter Physician name and Accession number for this
case, and click OK.
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.
Click OK to close the alert. If you need to change the Flush Medium setting, see
“Confirm Recording Settings” on page 5-10.
5-6
St. Jude Medical
Part Number ARTUS100088927
Performing an OCT Procedure
Preparing to Acquire OCT Recordings
5.
The screen displays the guidance message “Purge catheter with contrast” (Figure
5-2).
Figure 5-2: Purge Catheter guidance message
NOTE:
6.
To prevent this guidance message from appearing, check the box next to
the message “Do not show this screen again.”
Purge the Dragonfly Imaging Catheter's lumen with 100% contrast media from the
3 ml syringe to remove all air from the catheter. Flush until 3-5 drops exit from the
catheter's distal tip. Do not remove the syringe from the catheter purge port after
flushing.
CAUTION: The catheter must be purged prior to connection to the DOC.
ILUMIEN OPTIS System
Instructions for Use
5-7
Performing an OCT Procedure
Preparing to Acquire OCT Recordings
7.
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).
Figure 5-3: Plug Catheter into DOC guidance message
8.
Insert the hub of the catheter into the port of the DOC, and twist the hub clockwise
until secure (1/8 turn).
Lock LED
Figure 5-4: Dragonfly Catheter Connected to the DOC
5-8
St. Jude Medical
Part Number ARTUS100088927
Performing an OCT Procedure
Preparing to Acquire OCT Recordings
CAUTION: 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 the
internal optical fiber connection, and the green Connecting imaging catheter
progress bar at the bottom of the screen completes.
NOTE:
If the Connection Failure alert appears, unload the catheter (press
unload on the DOC) and try to load the catheter again. If this alert
appears again, replace the catheter.
NOTE:
If the connection or initial calibration is stopped, the Connection
Cancelled alert is displayed. If this alert appears, unload the catheter
(press unload on the DOC), click OK, and try to load the catheter
again.
On screen, the size and position of the outer sheath of the catheter is adjusted with
respect to the calibration marks (see Figure 5-5).
When the connection and initial calibration are complete, the confirmation message, Catheter connected, appears. The system goes into Standby View.
Figure 5-5: Catheter Connected, Initial Calibration done
ILUMIEN OPTIS System
Instructions for Use
5-9
Performing an OCT Procedure
Confirm Recording Settings
Confirm Recording Settings
After the catheter has been connected to the DOC, confirm all settings for this recording.
Non-sterile Operator
1.
Click the Settings button at the top of the screen.
A context-sensitive menu opens.
Figure 5-6: OCT Settings Menu (during Recording)
2.
Confirm all settings are correct for this recording.
NOTE:
If Flush Medium has been restricted to Contrast Only, you cannot
change the Flush Medium setting. See “Setup - Acquisition/Other
Menu” on page 10-4 for more information.
If Recording Type has been set to Stationary, you cannot change the
Pullback Length setting. See “Setup - Acquisition Menu” on page
10-2 for more information.
CAUTION: To obtain accurate measurements, be sure the selection for the
Flush Medium is the same as the medium in which you are imaging.
3.
5-10
NOTE:
Only 100% contrast media is approved for human OCT Imaging.
NOTE:
Clicking the Setup button at the bottom of the Settings menu opens
the ILUMIEN OPTIS System Setup dialog box. See Chapter 10 “User
Interface Reference” for more information.
Click Close to continue.
St. Jude Medical
Part Number ARTUS100088927
Performing an OCT Procedure
Dragonfly Imaging Catheter Insertion and Positioning
Dragonfly Imaging Catheter Insertion and Positioning
The guide catheter and guidewire must be inserted into the patient per normal clinical
procedures prior to insertion of the Dragonfly Imaging Catheter. The Dragonfly catheter
must be properly inserted into the guide catheter to ensure patient safety and proper operation.
Once the Dragonfly catheter has been inserted, its location, and the position of the guide
catheter, may be fine-tuned to ensure optimal imaging.
CAUTION: Ensure that no air is introduced into the system during the imaging
catheter insertion.
Non-sterile Operator
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 Vessel
and Procedure from the fields at the bottom of the screen.
Sterile Operator
2.
Back-load the Dragonfly catheter's rapid-exchange lumen onto the indwelling
0.014 inch guidewire.
3.
POSITION the catheter according to your catheter’s Instructions for Use.
CAUTION: Observe all advancement and movement of the Dragonfly Imaging Catheter under fluoroscopy. Always advance and withdraw
the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage. To
ensure proper placement, do not move the guidewire after the
Dragonfly catheter is in place.
If resistance is encountered during advancement of the Dragonfly Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or
mitigated, carefully remove the catheter and guidewire as a unit
from the patient.
Leave the guidewire engaged with the catheter at all times during use. Do not withdraw or advance the guidewire prior to withdrawing the catheter.
ILUMIEN OPTIS System
Instructions for Use
5-11
Performing an OCT Procedure
Dragonfly Imaging Catheter Insertion and Positioning
Non-sterile Operator
4.
Press the Live View button to start live-scan imaging (low-speed rotation of the
imaging core).
The ring around the Live View button on the DOC lights in green.
CAUTION: Monitor the OCT image for indications of catheter optical failure. If optical failure is suspected, return to Standby View (click
the Standby View button), remove the catheter, and replace it
with a new one.
NOTE:
5.
A pullback can not be started unless the optical fiber is fully
advanced.
Verify calibration as follows:
The image is correctly calibrated when the outermost “ring” of the catheter is centered between the 4 calibration marks.
Incorrect
Incorrect
Correct
Figure 5-7: Incorrect and Correct Calibration
NOTE:
5-12
Ensure accurate calibration prior to a recording. Incorrect calibration
may cause early pullback initiation and incorrect measurements.
You should adjust the calibration to the best approximate size
between the outer diameter of the catheter and the 4 calibration
marks.
•
To calibrate automatically, press the Auto-calibrate button. In the Image
Window, the position of the catheter outer sheath is adjusted close to its final
correct position with respect to the four calibration marks.
•
If necessary, click the Increase/Decrease buttons to calibrate
manually.
St. Jude Medical
Part Number ARTUS100088927
Performing an OCT Procedure
Dragonfly Imaging Catheter Insertion and Positioning
Sterile Operator
6.
PURGE the Dragonfly Imaging Catheter by injecting ~0.1 ml contrast using the
3 ml syringe to ensure no blood has diffused into the catheter lumen.
NOTE:
7.
Ensure the guide catheter is oriented to preferentially direct contrast flow to the target artery, and verify angiographically that adequate flow of contrast is delivered to
the artery.
NOTE:
8.
9.
Application of negative pressure to draw blood into the catheter is
not recommended. Blood in the catheter lumen will obscure the
image and can be difficult to completely purge.
PUFF-- Injecting a small “puff” of contrast while reviewing the
image on screen to verify that adequate flow of contrast is delivered
to the artery.
Whether using a syringe or 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 available
setting.
Verify the stopcock position on the manifold is set to allow flow from the injection
pump into the guide catheter.
ILUMIEN OPTIS System
Instructions for Use
5-13
Performing an OCT Procedure
Acquiring Patient Images
Acquiring Patient Images
The System Display during image acquisition is shown in Figure 5-8.
Patient Information
OCT Settings Button
Image Window
Recording
Calibration
Marks
Depth
Calibration
Marks
L-Mode Display
Recording (in progress)
Figure 5-8: System Display - Acquisition
Table 5-1: System Display Description - Acquisition
Patient Information
Displays the Patient name and ID.
OCT Settings button
Opens the OCT Settings menu.
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 seconds. 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 “Timeline.”
Recording (in progress) Displays the recording as it is completed.
5-14
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Part Number ARTUS100088927
Performing an OCT Procedure
Acquiring Patient Images
Non-sterile Operator
NOTE:
1.
If you are performing a Stationary recording, the Enable Pullback and
Start Pullback buttons are replaced with a Start Recording button. Do
not press the Start Recording button until you have notified the sterile
operator that the system is ready, and that the contrast media has been
injected.
Clicking the Start Recording button (or pressing the Enable button on the
DOC) begins the recording immediately; the system does not wait for a
clearing from the contrast injection.
With the system in Live View, click the Enable Pullback button to allow the system to detect initiation of the imaging flush. The green ring around the Live View
button on the DOC begins to flash and the DOC drive motor audibly speeds up.
The Enabled state lasts for 15 seconds.
2.
Notify the Sterile Operator that the system is enabled.
ILUMIEN OPTIS System
Instructions for Use
5-15
Performing an OCT Procedure
Acquiring Patient Images
Sterile Operator
3.
Begin contrast media injection (using syringe or automated power injector pump).
The system automatically begins a recording once a brief sequence of clear image
frames are detected indicating the area is flushed with contrast media.
NOTE:
If the Recording Type is set to Pullback, the recording takes
approximately 3 seconds. If set to Stationary, the recording takes
approximately 6 seconds.
If the Automatically review recordings option is enabled, the image file is displayed for review.
Review the recording and repeat it if needed. If the catheter is still connected to the DOC,
ask the non-sterile operator to click the New Recording button at the bottom of the
screen.
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Part Number ARTUS100088927
Performing an OCT Procedure
Removing the Dragonfly Imaging Catheter
Removing the Dragonfly Imaging Catheter
All information obtained during imaging is automatically saved with the recording. Once
imaging is completed, the data and images may be reviewed (see Chapter 6 “Reviewing
OCT Recordings”) or transferred to removable media for review on a St. Jude Medical
Offline Review Workstation (see Chapter 8 “Exporting, Importing, and Managing
Files”).
Non-sterile Operator
1.
Ensure that the Dragonfly catheter is not rotating (click on the Standby View button if necessary) before the sterile operator begins withdrawal and unloading.
Sterile Operator
2.
When all OCT imaging is complete, withdraw the Dragonfly catheter into the guide
catheter under fluoroscopic observation.
CAUTION: If resistance is encountered during withdrawal of the Dragonfly
Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the catheter and guidewire as a unit
from 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. Twist
the catheter hub counter-clockwise to disengage it from the DOC.
CAUTION: Handle the Dragonfly Imaging Catheter and all other disposables used during the procedure as potential biohazards. Dispose of in accordance with accepted medical practice and all
applicable laws and regulations.
ILUMIEN OPTIS System
Instructions for Use
5-17
Performing an OCT Procedure
Troubleshooting OCT Acquisition
Troubleshooting OCT Acquisition
Immediately Stopping DOC Operation
1.
2.
Press the Stop button on the DOC at any time to immediately stop operation of the
DOC. Pressing this button:
•
Turns off the DOC motors, thereby stopping all optical fiber movement, both
rotational and longitudinal.
•
Turns off the Imaging Engine light source.
•
Stops recording and freezes the image. If Automatically review recordings
is checked in the Configure tab of the Setup dialog box, it automatically
plays back the recording once it has been saved.
•
Prevents the imaging catheter lens from automatically advancing to its original distal position.
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 position, the system displays an alert: Catheter Must Be Advanced to Continue. Click the Advance Catheter button to advance the optical fiber
within the catheter shaft. You must advance the catheter before making another OCT recording.
5-18
St. Jude Medical
Part Number ARTUS100088927
Performing an OCT Procedure
Troubleshooting OCT Acquisition
Catheter Failure
NOTE:
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) during
either pullback or advance, the system stops automatically (and stops pullback/advance)
and displays the following message:
Figure 5-9: Catheter Failure message
CAUTION: Do not click the OK button until after you have removed the
Dragonfly 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 catheter, stop manipulation and evaluate under fluoroscopy. If the cause of
resistance cannot be determined or mitigated, carefully remove the
catheter 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.
After acknowledging the alert, a second alert is displayed as shown below.
Figure 5-10: Replace Catheter message
4.
Acknowledge this message by clicking on OK.
5.
Advance the optical fiber all the way to its forward position by pressing the Unload
button on the DOC.
ILUMIEN OPTIS System
Instructions for Use
5-19
Performing an OCT Procedure
Troubleshooting OCT Acquisition
5-20
6.
Remove the existing Dragonfly Imaging Catheter in the normal manner.
7.
Load a new Dragonfly Imaging Catheter in the normal manner.
St. Jude Medical
Part Number ARTUS100088927
Reviewing OCT Recordings
NOTE:
Making measurements, calculations, and text annotations is covered in
Chapter 7 “Measurements and Annotations”. Exporting images is covered
in Chapter 8 “Exporting, Importing, and Managing Files”.
ILUMIEN OPTIS System
Instructions for Use
6-1
Reviewing OCT Recordings
Image Window
Image Window
The Image Window shows a cross-section view of the recording or still frame (Table 6-1).
Table 6-1: OCT Display Overview
D E F
Patient name and ID.
See “Entering New Patient Information” on page 3-5 for more information.
Patient Summary button: Click to open a list of all recordings for this patient.
See “Patient Summary Menu” on page 3-4 for more information.
Recording date and time.
Export button: Click to open the Export Wizard.
See Chapter 8 “Exporting, Importing, and Managing Files” for more information.
Capture button: Available on a still frame or paused recording. Click to save the current
frame.
Print 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 6-12 for more information.
Settings button: Click to open the (Playback) Settings menu.
See “Adjust Playback Settings” on page 6-8 for more information.
6-2
St. Jude Medical
Part Number ARTUS100088927
Reviewing OCT Recordings
Image Window
Table 6-1: OCT Display Overview
Frame number: Available on a paused recording.
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.
Bookmark controls: Add bookmarks to the L-Mode view.
See “Bookmark Controls” on page 6-9 for more information.
End Review / New Recording : Click the End Review button to close this window and
return to the Patient Summary menu.
NOTE: While the ILUMIEN OPTIS System is connected to a Dragonfly imaging catheter, the
button New Recording appears here. Click the New Recording button to close this
review and begin a new OCT recording.
Playback controls: Control the playback of the OCT recording. Not available with still
images.
See “Playback Controls” on page 6-6 for more information.
Procedure list: Click to open a drop-down list of procedures to describe this recording.
Vessel list: Click to open a drop-down list of vessels to describe this recording.
Adjust Calibration button: Click to open the playback calibration controls.
See “Calibration Adjustment” on page 6-7 for more information.
L-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.
Image Window: A cross-section view of the vessel.
Annotations Panel: Control display features including L-Mode and optional features such as
3D and Lumen Profile. This section also lists measurements from the current image; click
on a measurement to highlight it in the Image Window.
ILUMIEN OPTIS System
Instructions for Use
6-3
Reviewing OCT Recordings
L-Mode View
L-Mode View
NOTE:
If reviewing a Stationary recording, the L-Mode display is renamed Timeline. The Timeline represents the stationary view of the catheter during the
six seconds of recording.
During the OCT pullback recording, the system captures evenly spaced cross-section
images and uses them to construct a lateral view of the vessel anatomy. The lateral view
is shown in the L-Mode display in the lower portion of the screen; the distal portion of the
recording is to the left.
Click an L-Mode to display it. The system can show up to two cut-plane
views at a time. If two L-Mode views are shown, the second view is offset from the first view by 90 degrees.
NOTE:
If you have the Lumen Profile option, you cannot have the Lumen Profile
display and Dual L-Mode displays on screen at the same time.
Table 6-2: L-Mode views
L-Mode: Single
Single L-Mode cut-plane indicator. This cut-plane is shown as a solid line in the cross-section view. Click and drag this to change the lateral view shown in the L-Mode display.
Single L-Mode display.
Second (Dual) L-Mode cut-plane indicator. This cut-plane is shown as a dashed line in the
cross-section view, offset from the first view by 90 degrees. Click and drag either
cut-plane indicator to change the lateral views.
Second (Dual) L-Mode display.
NOTE:
6-4
L-Mode: Dual
The width of the L-Mode window represents the entire range of the recording.
St. Jude Medical
Part Number ARTUS100088927
Reviewing OCT Recordings
L-Mode View
Limitations of L-Mode Data
Please 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 be
representative of the actual vessel lumen.
•
The vessel diameter shown in the L-Mode reconstruction may appear significantly
smaller than the actual diameter when the catheter position is off center and close to
the vessel wall. To avoid misinterpreting the image when this occurs, rotate the cutplane to examine all views of the L-Mode.
•
Although a vessel may curve, the L-Mode view always appears straight because of
the limitations of reconstruction.
•
Artifacts caused by the relative motion of the catheter and the vessel often result in
a saw-toothed appearance of the reconstruction and can lead to misinterpretation by
inexperienced users.
•
Shortening or lengthening artifacts in the L-Mode reconstruction may occur due to
the relative motion of the Dragonfly catheter with respect to the coronary artery
caused by the patient’s heart motion.
ILUMIEN OPTIS System
Instructions for Use
6-5
Reviewing OCT Recordings
Playback Controls
Playback Controls
Table 6-3: Playback Controls
D E
Adjust Calibration: Press to open the Calibration menu. Only available with a still
image or paused recording.
Vessel list: Click to open a drop-down list of vessels to describe this recording.
Procedure list: Click to open a drop-down list of procedures to describe this recording.
Step 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.
Play/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.
Step 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.
End 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 button
New Recording appears here. Click the New Recording button to close
this review and begin a new OCT recording.
6-6
St. Jude Medical
Part Number ARTUS100088927
Reviewing OCT Recordings
Calibration Adjustment
Calibration Adjustment
Use 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.
Click on the Adjust Calibration button at the bottom of the screen.
The Calibration tool opens. The image is zoomed and the calibration circle with two
control points is sized approximate to the outside diameter of the catheter.
Figure 6-1: Playback Calibration (in progress)
3.
Click and drag on the control points until the calibration circle traces the outside
diameter of the catheter as shown in the sample picture at the bottom of the screen.
NOTE:
4.
Adjustments made here are for size, not alignment. The catheter may
not appear centered in all frames during playback. This is normal.
Click the Accept button save the calibration, or click Cancel to close the calibration
tool without saving the adjustment.
NOTE:
ILUMIEN OPTIS System
Instructions for Use
If necessary, you can return the recording to its default calibration by
clicking the Remove Adjustment button.
If you remove or change the calibration, any changes that you have
made to the automatically-generated Lumen Profile contours are
reset. See “Lumen Profile Display Option” on page 7-19 for more
information.
6-7
Reviewing OCT Recordings
Adjust Playback Settings
Adjust Playback Settings
1.
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-section 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 white
balance in the image.
5.
Click the arrow on the Field of View drop-down menu to display the list of diameter sizes.The default setting is 7.0 mm.
The Field of View setting controls the size of the image displayed on screen. A
smaller Field of View setting equals a larger magnification. Click a size to select it.
Field of View 10.0 mm
Field of View 5.0 mm
Figure 6-2: Field of View Settings
6.
6-8
Click Close to continue.
St. Jude Medical
Part Number ARTUS100088927
Reviewing OCT Recordings
Bookmark Controls
Bookmark Controls
The System allows you to add bookmarks to mark frames for further review.
NOTE:
Bookmark controls are only available when an L-Mode view is displayed
in a recording.
Table 6-4: Bookmark Controls
Add/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.
Previous 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.
Next Bookmark : Seeks forward to the next bookmarked frame. If there are no subsequent bookmarks, it continues seeking from the beginning of the recording. Unavailable
if there are no bookmarks.
Clear All Bookmarks : Clears all bookmarks from the current recording. Unavailable
if there are no bookmarks.
ILUMIEN OPTIS System
Instructions for Use
6-9
Reviewing OCT Recordings
Setting Playback Range
Setting Playback Range
By default, the system plays the entire length of a pullback during the review. You can
shorten 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-Mode
view. By default, they are at the distal and proximal ends of the recording.
Playback Range markers
Current Frame Indicator
Figure 6-3: Adjusted Playback Range
To change the playback range:
6-10
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 the
area to be played during review.
NOTE:
If the recording is exported as an AVI file, this range determines the length
of the exported recording.
NOTE:
If the L-Mode view is changed (for example, turned Off), the playback
range is restored to the full length of the recording.
St. Jude Medical
Part Number ARTUS100088927
Reviewing OCT Recordings
Exporting a Recording or Still Frame
Exporting a Recording or Still Frame
Refer to Chapter 8 “Exporting, Importing, and Managing Files” for more information on exporting a recording or still frame.
Capturing Still Images
You can use the Capture button to save a still image from a recording, or to save
a copy of an existing still frame. All measurements and annotations on that screen
are saved with the captured image.
NOTE:
The Capture button is unavailable while a recording is playing. Pause the
playback at the frame that you want to capture.
Saving a Still Image
1.
Display the frame that you want to capture.
2.
Click the Capture button.
A confirmation message appears, and the captured image appears in the Patient
Summary menu.
NOTE:
The still image is saved with the same date as the source file. It is
grouped in the Patient Summary menu with other recordings and
images of the same date.
In the Patient Summary menu, the system adds the frame number to the title of the
captured image (for example, “OCT Frame 145”).
ILUMIEN OPTIS System
Instructions for Use
6-11
Reviewing OCT Recordings
Printing Still Images
Printing Still Images
You 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 measurements
and annotations on that screen are saved with the captured image.
NOTE:
The Print button is unavailable while a recording is playing. Pause the
playback 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 10-20 for more information.
Printing a Still Image
1.
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.
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Part Number ARTUS100088927
Measurements and Annotations
Measurements and Text Callouts in the Image Files
Measurements and text callouts that are added to images do not change the underlying
image data. The unannotated image is always preserved and can be reviewed without the
measurements and callouts. All measurements and annotations added during the procedure are preserved in the file.
Measurements and text callouts can be modified or deleted, and pen color, line width and
point size can be set. In addition, pen color can be set to automatically cycle so that subsequent measurements are displayed in different colors. For information on setting pen
color, line width, and point size, see “Setup - Measurements/Labels Menu” on page
10-18.
CAUTION: If you want to make measurements on files which will be exported to
standard formats, you must make the measurements BEFORE
exporting the images. Using non-OCT software to measure standard
format images will not produce accurate measurements.
CAUTION: Do not use images that have been exported to JPEG or Compressed
AVI formats for clinical decision making. These formats use compression methods that may degrade the image quality.
NOTE:
All measurements and calculations can be made in the cross-section view
of the OCT image, but only horizontal length measurements and text annotations can be made in the L-Mode view.
ILUMIEN OPTIS System
Instructions for Use
7-1
Measurements and Annotations
Measurement and Annotation Tools
Measurement and Annotation Tools
When the OCT playback is paused,
or displaying a still image, the measurement and annotation tools are
available on screen. As measurements are added to the image, they
are labeled with successive control
letters (A, B, C, etc., up to 26 measurements per frame).
Figure 7-1: Measurement and Annotation Tools
NOTE:
Tools have a black background when they are unavailable.
Table 7-1: Measurement and Annotation Tool Functions
Area - 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
6-8 for more information.
Delete All Annotations : Click to delete all annotations and measurements.
NOTE:
7-2
After a measurement or text annotation 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 to jump to it.
St. Jude Medical
Part Number ARTUS100088927
Measurements and Annotations
Verifying Calibration
Verifying Calibration
Before making measurements, you must verify the calibration. If the calibration for this
recording or still image has not been adjusted, or if it has been reset, the calibration tool
appears when you begin to take a measurement. See “Calibration Adjustment” on page
6-7 for more information.
Once the calibration is accepted, you can begin taking measurements.
Techniques to Improve Measurement Accuracy
Follow these guidelines to improve measurement accuracy:
•
Before making measurements, use the Zoom function to zoom into the region of
interest 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 measurement
technique 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 View
All annotations and measurements are typically made in the cross-section view area of the
Image 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-Mode
is not recommended for quantization of clinical information.
ILUMIEN OPTIS System
Instructions for Use
7-3
Measurements and Annotations
Length Measurements
Length Measurements
The 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
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Part Number ARTUS100088927
Measurements and Annotations
Length Measurements
Making a Length (Distance) Measurement
1.
Select the still image or paused recording that you want to measure.
2.
Click on the Length button (Figure 7-1). The cursor changes to a pen.
3.
Click anywhere in the Image Window (cross-section view or L-Mode view) to
place the starting point for the length measurement.
NOTE:
4.
Both start and end points must be in the same view. For
example, if the starting point is placed in the cross-section
view, the end point must also be in the cross-section view.
To cancel the measurement, press the  key or click
the Cancel button.
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 Annotations
Panel. If you position the cursor over the line, the length is shown over the center of
the line.
ILUMIEN OPTIS System
Instructions for Use
7-5
Measurements and Annotations
Area Measurements
Area Measurements
You can manually create a closed area trace of the lumen contour in the cross-section view. The area is calculated using Green’s Theorem, and is displayed in the
frame in mm2 with the minimum and maximum diameter chords.
NOTE:
If the Automatic MLA and %DS option is enabled and you are reviewing
a pullback recording, your system automatically adds a “Lumen Profile”
measurement on each frame.
NOTE:
The minimum diameter chord has arrowheads that point inward (toward
the diameter chord). The maximum diameter chord has arrowheads that
point outward.
Making a Manual Area Measurement
1.
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 a
pen.
3.
Use the mouse to position the pen cursor at the desired starting point for the area in
the cross-section view and click to set the point.
Figure 7-3: Manual Area Measurement (in progress)
7-6
St. Jude Medical
Part Number ARTUS100088927
Measurements and Annotations
Area Measurements
NOTE:
4.
5.
Click the Undo button to the left of the toolbar to delete the
most recent point added to the image.
Continue to add points with the pen cursor until you have accurately traced the area
to be measured. You can place as many points as you like around the border of the
desired area. At least three points are required.
NOTE:
The first two points are connected by a straight line. When you place
subsequent points, the straight line becomes a smooth curve connecting all points but not closing the area until you click the Accept
button, or the last point is sufficiently close to the initial point for the
system to automatically complete the area. Placing more points
increases measurement accuracy.
NOTE:
You must click either Accept or Cancel to complete the
measurement. Click Cancel to completely erase the measurement.
Click the Accept button to the left of the toolbar to save the measurement, or click
the Cancel button to cancel it.
ILUMIEN OPTIS System
Instructions for Use
7-7
Measurements and Annotations
Adding Text Callouts
Adding Text Callouts
You can add text callouts to a single frame or to the entire recording.
Figure 7-4: Text Callouts
7-8
St. Jude Medical
Part Number ARTUS100088927
Measurements and Annotations
Adding Text Callouts
Adding Text Callouts
1.
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.
Figure 7-5: Enter Note Dialog Box
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 checkbox. (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 desired
position.
8.
To change the position of the callout line, click the end of the line and drag it to the
desired position.
ILUMIEN OPTIS System
Instructions for Use
7-9
Measurements and Annotations
The %AS Calculation
The %AS Calculation
The %AS (Percent Area Stenosis) calculation calculates the percentage size of a
smaller area with relationship to a larger area, typically the area of the inner border
of a vessel compared to the area of the outer border.
Formula for %AS Calculation
%AS = (First Area-Second Area)/First Area * 100
To make this calculation, you must have two areas drawn on the current frame.
Make a %AS Calculation
1.
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 Measurement
dialog box.
Figure 7-6: Select Area Measurement Dialog Box
7-10
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.
St. Jude Medical
Part Number ARTUS100088927
Measurements and Annotations
The %AS Calculation
The % Area Stenosis calculation is displayed immediately below the previous calculations in the Annotation Panel as shown in Figure 7-7.
Figure 7-7: %AS Calculation
NOTE:
If the second measurement you select is larger than the first measurement, a %AS value will not be displayed. Instead, the Annotation
Panel displays an error message, similar to the one shown in Figure
7-8.
Figure 7-8: %AS Error Message
ILUMIEN OPTIS System
Instructions for Use
7-11
Measurements and Annotations
The %DS Calculation
The %DS Calculation
The %DS (Percent Diameter Stenosis) calculation calculates the percentage size of
a smaller length with relationship to a larger one, typically the diameter of the inner
border of a vessel compared to the diameter of the outer border.
Formula for %DS Calculation
%DS = (First Length-Second Length)/First Length * 100
To make this calculation you must first draw and specify two lengths, one for the smaller
diameter and one for the larger diameter.
Make a %DS Calculation
1.
Make two length measurements in the current frame.
2.
Click on the %DS button (Figure 7-1) to display the Select Length Measurement
dialog box.
Figure 7-9: Select Length Measurement Dialog Box
7-12
3.
In the Outer Measurement list, click the longer length.
4.
In the Inner Measurement list, click the shorter length.
5.
Click OK.
St. Jude Medical
Part Number ARTUS100088927
Measurements and Annotations
The %DS Calculation
The % Diameter Stenosis calculation is displayed immediately below the previous
calculations in the Annotations Panel, as shown in Figure 7-10.
Figure 7-10: %DS Calculation
NOTE:
ILUMIEN OPTIS System
Instructions for Use
If the second measurement is larger than the first measurement you
select, a %DS value will not be displayed. Instead, the Annotation
Panel displays an error message, similar to the one shown in Figure
7-8 for %AS.
7-13
Measurements and Annotations
Field of View
Field of View
You can zoom out on a recording or still image in order to see the full lumen on a large
vessel, 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 View
Click to increase the field of view on the recording or still image. Click again to
return to normal image size.
NOTE:
Depending on the current Flush Medium, the image may not occupy the
entire 10.5 mm diameter.
You can change the magnification of the zoomed field. See “Adjust Playback Settings”
on page 6-8 for more information.
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Part Number ARTUS100088927
Measurements and Annotations
Field of View
Zooming In Manually
You 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, displaying the magnification factor used (ex. Zoom: 2.5x, see Figure 7-11).
The system adds an overall view of the image to the right.
Figure 7-11: Zooming an Image
3.
To return to normal imaging, click anywhere in the zoomed image.
ILUMIEN OPTIS System
Instructions for Use
7-15
Measurements and Annotations
Editing Measurements and Annotations
Editing Measurements and Annotations
All measurements and annotations can be moved, deleted, or edited.
•
Area and length measurements can be adjusted by moving or deleting control
points.
•
Text annotations can be moved or deleted.
NOTE:
7-16
When a measurement is changed, calculations that depend on that measurement are updated automatically.
St. Jude Medical
Part Number ARTUS100088927
Measurements and Annotations
Editing Measurements and Annotations
Moving Individual Points
To 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, indicating that it may now be moved.
NOTE:
If you move a point on an automatically-generated Lumen Profile
contour, an arrow icon appears in the corner of the measurement
listed in the Annotations Panel. Click the arrow to reset the contour
on that frame back to the automatically-generated Lumen Profile contour.
See “Lumen Profile Display Option” on page 7-19 for more information.
Adding Points to a Multiple Point Area
To 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 Area
To delete selected points in a multiple point area, click on the desired point and press the
 key on the keyboard.
NOTE:
When you select a point, it changes from a circle to a square, indicating
that it may now be deleted.
ILUMIEN OPTIS System
Instructions for Use
7-17
Measurements and Annotations
Editing Measurements and Annotations
Deleting Individual Measurements or Text Callouts
NOTE:
If a measurement is in use with a calculation (for example, an area
used by %AS), the individual measurement cannot be deleted until
the 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 appears
around the label.
2.
Press the  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  key on the keyboard.
The text callout is deleted.
Deleting All Measurements and Text Callouts
Click to delete all measurements, calculations, and text callouts from this recording
or still image.
NOTE:
7-18
Contours generated automatically by the Lumen Profile function are not
deleted. If you have used the Lumen Profile function to calculate the minimum lumen area, that measurement is not deleted.
St. Jude Medical
Part Number ARTUS100088927
Measurements and Annotations
Lumen Profile Display Option
Lumen Profile Display Option
The system automatically creates a trace of the lumen contour on each
frame. Add a check to the Lumen Profile checkbox to display a graph of
the lumen profile.
NOTE:
Lumen Profile is not available with still images or stationary recordings.
A single L-Mode view must be turned on in order to use the Lumen Profile
display option. Lumen Profile display cannot be used with Dual L-Mode
displays.
Remove the check from the Measurements checkbox to hide the lumen
contour trace and corresponding measurements.
The Lumen Profile display opens with Minimum Lumen Area (MLA) and a percent stenosis graph (%AS or %DS) turned on:
•
MLA displays the Minimum Lumen Area controls and values for this recording.
•
%DS shows how the mean diameter changes along the length of the recording.
•
%AS shows how the lumen area changes along the length of the recording.
ILUMIEN OPTIS System
Instructions for Use
7-19
Measurements and Annotations
Lumen Profile Display Option
Lumen Profile Display With MLA Controls Overview
CAUTION: It is the user’s responsibility to confirm the lumen contour on each
frame, and to make adjustments if necessary.
Red frames indicate low confidence in the detected contour. If the
MLA frame is in the vicinity of a low confidence region, the system
displays “?.??” for the MLA values. If the MLA values are “?.??,” the
contour on the MLA frame must be reviewed, edited if necessary, and
accepted before it can be displayed.
Table 7-2: MLA Controls
Distal and Proximal Boundaries : Move these to set the range for MLA calculation. The
system’s search for a minimum lumen area occurs on frames between the distal and proximal boundaries.
See Table 7-3 on page 7-21 for more information on calculations.
• If %DS is selected in the Lumen Profile, the boundaries display the percent diameter
stenosis at each end of the range.
• If %AS is selected, the boundaries display the percent area stenosis at each end of the
range.
7-20
The lumen area is colored black.
Where the system has high confidence in the contour of the lumen area, or where the contour has been accepted by the user, the section is colored brown.
Calculated MLA : The dashed line indicates the position of the minimum lumen area
between the distal and proximal boundaries (A).
Where the system has low confidence in the contour of the lumen area, the section is colored 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 contour.
St. Jude Medical
Part Number ARTUS100088927
Measurements and Annotations
Lumen Profile Display Option
Table 7-3: Lumen Profile %AS and %DS Calculations
When 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
%AS = 100 * (AREF - AMLA) / AREF
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.
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 individual distal and proximal references (values
listed above the D or P
Boundaries):
%DS = 100 * (DD or P - DMLA) / DD or P
%AS = 100 * (AD or P - AMLA) / AD 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.
where AD or P is the Distal
Reference’s area or the Proximal
Reference’s area. AMLA is the
Minimum Lumen Area.
ILUMIEN OPTIS System
Instructions for Use
7-21
Measurements and Annotations
3D Display Option
3D Display Option
Click the 3D button to create a 3D representation of the recording.
NOTE:You cannot add or change measurements or annotations in the
cross-section view or 3D Display while 3D Display is on. You can add
annotations and distance measurements to the L-Mode view only.
3D Display is not available with still images or stationary recordings.
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Part Number ARTUS100088927
Measurements and Annotations
3D Display Option
3D Navigation Controls
Table 7-4: 3D Navigation Controls
3D Display
Cross-Section View
Cut Plane Angle Indicator : Click and drag around the vessel to change the cut plane as shown
in the L-Mode.
Frame Dragger : Click and drag along the length of the vessel to change the frame shown in
the cross-section view.
Volume Clip Controls : Click and drag these to open or close the 3D rendered wall of the vessel shown in the 3D Display. As the Volume Clip is opened, the wall of the vessel is removed in
the 3D Display, allowing you to see inside the rendered vessel.
NOTE: The blue line in the cross-section view represents your “line of sight” into the open vessel. The dashed yellow lines represent the edge of the opening into the rendered vessel.
Volume Clip Display : Displays the opening in the rendered vessel as defined by the Volume
Clip Controls.
Click and drag the divider bar side to side to change the size of 3D Display versus cross-section
view.
Zooming : Click in the 3D Display area and use the scrollwheel to zoom in or out.
ILUMIEN OPTIS System
Instructions for Use
7-23
Measurements and Annotations
3D Display Option
3D Display with Segmented Lumen
NOTE:
If the Segmented Lumen setting is turned on, the 3D Navigation setting is
turned off, and vice-versa. Selecting one deselects the other.
The Segmented Lumen setting adds a 3D representation of the lumen contours drawn on
each frame.
Figure 7-12: 3D Display with Segmented Lumen
NOTE:
If you have the MLA setting turned on under the Lumen Profile display,
the distal, proximal, and MLA frames are displayed.
Proximal
MLA
Distal
Figure 7-13: MLA Frames in 3D
7-24
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Part Number ARTUS100088927
Measurements and Annotations
3D Display Option
Limitations of 3D Display
Please be aware of the following limitations of the 3D Display Option:
•
Although a vessel may curve, the 3D Display view always appears straight because
of the limitations of reconstruction.
•
Artifacts caused by the relative motion of the catheter and the vessel often result in
a saw-toothed appearance of the reconstruction and can lead to misinterpretation by
inexperienced users.
•
Shortening or lengthening artifacts in the 3D Display reconstruction may occur due
to the relative motion of the imaging catheter with respect to the coronary artery
caused by the patient’s heart motion.
ILUMIEN OPTIS System
Instructions for Use
7-25
Measurements and Annotations
3D Display Option
7-26
St. Jude Medical
Part Number ARTUS100088927
Exporting, Importing, and Managing Files
CAUTION: Please note St. Jude Medical makes no representation or warranty
that use of the ILUMIEN OPTIS System complies with applicable privacy, security and confidentiality laws, but encourages you to assess
your own risk as you use, disclose, control, process or transfer patient
health information with the ILUMIEN OPTIS System.
ILUMIEN OPTIS System
Instructions for Use
8-1
Exporting, Importing, and Managing Files
Compatible Transfer Media and USB Devices
Compatible Transfer Media and USB Devices
The 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 Media
The system can export files through the CD/DVD drive. Table 8-1 lists the supported disc
formats and describes whether they can be erased and/or appended.
Table 8-1: Optical Media Characteristics
Media
Capacity
Can Erase
Can Append
CD-R
737 MB
CD-RW
737 MB
DVD+R
4.7 GB
DVD+RW
4.7 GB
DVD+R Dual Layered
8.5 GB
DVD-R
4.7 GB
DVD-RW
4.7 GB
DVD-R Dual Layered
8.5 GB
DVD-RAM
4.7 GB
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 data
on it, an alert message appears. Click OK to erase the disc and export your files, or click
Cancel to cancel the export.
If you try to export files to a disc that cannot be formatted or appended (such as DVD+R
DL and DVD-R DL), an alert message appears. Insert a new disc to continue, or click
Cancel to cancel the export.
USB Connected Media
The system can export files through the USB port (see Figure 1-3 on page 1-6). Any USB
hard drive or Flash Drive that meets the USB 2.0 Specification and is supported by Windows 7 SP1 may be used.
8-2
St. Jude Medical
Part Number ARTUS100088927
Exporting, Importing, and Managing Files
Compatible Transfer Media and USB Devices
WARNING: Inside the catheterization lab only port-powered USB drives may be
connected to the USB port. Connecting externally powered devices to
the USB port in the patient vicinity may compromise electrical isolation and cause patient injury.
NOTE:
Outside the catheterization lab, IEC 60950-compliant, externally powered
USB hard drives may be connected to the USB port.
ILUMIEN OPTIS System
Instructions for Use
8-3
Exporting, Importing, and Managing Files
File Formats
File Formats
Files can be exported in either the native file format (raw OCT format) or in a standard
graphic file format (standard format). Exported files can be saved on the system’s hard
drive, or transferred to a CD/ DVD or external USB device. You can choose whether to
delete files after transfer or keep them on the system.
About Native (Raw OCT) Format
If you export in native (raw OCT) file format, every feature of the OCT file will be
exported, and the files can be imported into another ILUMIEN or ILUMIEN OPTIS System
or an Offline Review Workstation (ORW) and reviewed and manipulated there. An
exported OCT file contains exactly the same data as the original file, including any measurements and annotation additions, all patient information associated with each file, and
system diagnostic information to help diagnose possible image quality problems.
Note the following:
•
Native (raw OCT) files can be reviewed and manipulated only with an ILUMIEN
System, an ILUMIEN OPTIS System, or an ORW. They cannot be accessed with any
other systems or software.
•
Native (raw OCT) files are large; exporting to CD/DVD may require many discs.
About DICOM Format
For a multiple-frame recording using DICOM format stored on a network server, the
maximum resolution is 800 x 800.
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St. Jude Medical
Part Number ARTUS100088927
Exporting, Importing, and Managing Files
File Formats
About Standard Format
If you export in standard file formats (AVI, compressed AVI, or Multi-page TIFF for
recordings; JPEG, TIFF, or BMP for images), the images can be used in computer applications outside the system, but cannot be imported into an ILUMIEN System, an ILUMIEN
OPTIS System, or an ORW. When exported to formats other than DICOM, only the
images, measurements, and annotations are exported, with no system or patient information.
NOTE:
For standard format multiple-file exports, the same limitations apply as
described in “Image Format and Size in Standard Formats”. Just as when
exporting a single file, you can choose the size and format.
ILUMIEN OPTIS System
Instructions for Use
8-5
Exporting, Importing, and Managing Files
Image Format and Size in Standard Formats
Image Format and Size in Standard Formats
When exporting files in standard formats, the system gives you several choices of format
and 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 quantitative
data, annotations or measurements are lost.
•
Increasing resolution results in higher image quality in the exported file. For
a file that is a single frame (from a captured image, a paused image, or from
a recording that has been edited down to only one frame), the maximum resolution 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 application. When images are enlarged or reduced by the system, the maximum useful
information is preserved. External applications may not apply the same diligence
when enlarging or reducing an image.
Standard File Format
•
•
8-6
The system can export recordings as either AVI, compressed AVI, or Multi-page
TIFF format.
•
Most computers include standard players that will play AVI format files.
•
The Compressed AVI and Multi-page TIFF formats require that special players for these formats be installed on the computer you will use to review the
files.
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 a
computer application. They are significantly smaller than TIFF or BMP files,
and are typically the best choice for slide shows or other applications where
the files will be viewed on a computer monitor.
St. Jude Medical
Part Number ARTUS100088927
Exporting, Importing, and Managing Files
Exporting Files During a Review
Exporting Files During a Review
During review, you can use the Export button to export the current recording or still
image to Native (Raw) format, DICOM format, or standard file formats.
Figure 8-1: Export Button (OCT)
NOTE:
The Export button is unavailable while a recording is playing. To export
from a recording, pause the recording before clicking the Export button.
All edits, including measurements, calculations, annotations and zoom, are included with
the recording or still image when it is exported (see Chapter 7 “Measurements and Annotations”).
CAUTION: If you are exporting to standard formats, make all measurements
BEFORE exporting. Using non-OCT software to measure standard
format images will not produce accurate measurements.
CAUTION: Do not use images that have been exported to JPEG or Compressed
AVI formats for clinical decision making. These formats use compression methods that may degrade the image quality.
NOTE:
Editing images stored on the system does not change the underlying image
data in any way. All unedited data taken during the procedure is always
preserved and can be reviewed without the changes.
NOTE:
If the system displays an error message during export, a restart may be
required. If necessary, click OK to restart the system. If the error condition
persists, export the recording from the Patient Summary menu, or reduce
the resolution for the export of the recording. See “Exporting Files from
the Patient Summary Menu” on page 8-14 for more information.
ILUMIEN OPTIS System
Instructions for Use
8-7
Exporting, Importing, and Managing Files
Exporting Files During a Review
Exporting Files in Native (Raw) Format
1.
Click the Export button.
The Export Wizard opens (see Figure 8-2).
Figure 8-2: The Export Wizard - Step 1
2.
Click to select Native (Raw), and click Next.
3.
If you need to remove patient identifying information from the exported files, add
a check to the Anonymize checkbox.
•
If you have added a check to the Anonymize checkbox, you can also add an
alternate means of identifying the patient. Click the Alternate PIDs... button
to open the Define Alternate Patient ID menu:
•
Click in the Alternate Patient ID column and type an alternate ID tag
for this patient.
Figure 8-3: Define Alternate Patient ID Menu
•
8-8
Click the Auto-Generate button to add an alternate ID generated by the
system. Click the Reset button to clear the ID generated by the system.
St. Jude Medical
Part Number ARTUS100088927
Exporting, Importing, and Managing Files
Exporting Files During a Review
•
4.
5.
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 System
are not changed.
•
Mark as Archived - the files are exported, and marked as archived.
•
Remove when Complete - the files are deleted from the System once the
export is complete.
Click Next to approve the settings and open the next page of the Export Wizard.
NOTE:
6.
Click OK to approve the change and close the menu, or Cancel to
return to previous settings and close the Define Alternate Patient ID
menu.
Click Back to return to the previous page, or click Cancel to exit the
Export Wizard without exporting files.
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 large
enough 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 Label
field.
•
Click External Drive to export to an external USB device.
If necessary, click the External Drive selection box to select the correct drive
location from the drop-down menu.
Click the Ellipsis (...) button to the right of the Path selection box to browse
for 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 Export
Information.
8.
Click Export to export the selected files.
The export begins. If necessary, click Cancel to stop the export in progress.
ILUMIEN OPTIS System
Instructions for Use
8-9
Exporting, Importing, and Managing Files
Exporting Files During a Review
9.
When complete, click Done to close the Export Wizard.
Exporting Files in DICOM Format
1.
Click the Export button.
The Export Wizard opens (see Figure 8-2).
2.
Click to select DICOM, and click Next.
NOTE:
3.
4.
If you are reviewing a single frame instead of a recording, skip to Step 5
Click to select the material to be exported:
•
Pullback
•
Current Frame
•
Bookmarked Frames - This choice is unavailable if there are no bookmarked frames in the recording.
Click Next to approve the settings and open the next page of the Export Wizard.
NOTE:
8-10
Click Back to return to the previous page, or click Cancel to exit the
Export Wizard without exporting files.
5.
If you need to remove patient identifying information from the exported files, add
a 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 System
are 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 large
enough to save the files that are being exported.
St. Jude Medical
Part Number ARTUS100088927
Exporting, Importing, and Managing Files
Exporting Files During a Review
•
Click CD/DVD to export to a CD/DVD.
If the inserted CD/DVD is blank, you can edit the name in the Volume Label
field.
•
Click External Drive to export to an external USB device.
If necessary, click the External Drive selection box to select the correct drive
location from the drop-down menu.
Click the Ellipsis (...) button to the right of the Path selection box to browse
for a specific folder on the device.
•
Click Remote Store to export to a network DICOM Server.
NOTE:
9.
The Remote Store option is enabled only if the DICOM network connection has been configured on the DICOM tab of
the Setup dialog box (see Chapter 10 “User Interface Reference”for more information on DICOM settings).
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 Information.
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.
ILUMIEN OPTIS System
Instructions for Use
8-11
Exporting, Importing, and Managing Files
Exporting Files During a Review
Exporting Files in Standard Formats
NOTE:
1.
3D reconstructions cannot be exported in Standard formats.
Click the Export button.
The Export Wizard opens (see Figure 8-2).
2.
Click to select Standard, and click Next.
NOTE:
3.
4.
If you are reviewing a single frame instead of a recording, skip to Step 5.
Click to select the material to be exported:
•
Pullback
•
Current Frame
•
Bookmarked Frames - This choice is unavailable if there are no bookmarked frames in the recording.
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 the
Export 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 a
filename 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 large
enough 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 Label
field.
8-12
St. Jude Medical
Part Number ARTUS100088927
Exporting, Importing, and Managing Files
Exporting Files During a Review
•
Click External Drive to export to an external USB device.
If necessary, click the External Drive selection box to select the correct drive
location from the drop-down menu.
Click the Ellipsis (...) button to the right of the Path selection box to browse
for 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 Export
Information.
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.
ILUMIEN OPTIS System
Instructions for Use
8-13
Exporting, Importing, and Managing Files
Exporting Files from the Patient Summary Menu
Exporting 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 you
want to export.
Figure 8-4: Highlighted Records
A white border appears around each record that is selected.
2.
NOTE:
In the Patient Summary menu, you can select multiple files from
the same date, but not from different dates. Within the Export Wizard, you can select additional files from different dates and different
patients.
NOTE:
To deselect a file, clear the check from the checkbox. The check and
white border disappear to indicate that the file is no longer selected.
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.
8-14
St. Jude Medical
Part Number ARTUS100088927
Exporting, Importing, and Managing Files
Exporting Files from the Patient Summary Menu
4.
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.
6.
•
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
recordings.
Click Next to approve the list of files for export and open the next page of the
Export Wizard.
•
If you are exporting in Native (Raw) format, refer to Step 3 in “Exporting
Files 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 in
DICOM Format” on page 8-10 to continue the export.
•
If you are exporting in standard formats, refer to Step 5 in “Exporting Files in
Standard Formats” on page 8-12 to continue the export.
ILUMIEN OPTIS System
Instructions for Use
8-15
Exporting, Importing, and Managing Files
Using Exported Standard Format Recordings
Using Exported Standard Format Recordings
The system can export recordings as either AVI, compressed AVI, or Multi-page TIFF
format. Most computers include standard players that will play AVI format files. However, the Compressed AVI format and the Multi-page TIFF formats require that you have
special players installed on your computer to review the files.
St. Jude Medical DICOM Viewer
When an image file is exported to a CD/DVD in the DICOM format, the St. Jude Medical
DICOM Viewer (shown in Figure 8-5) is also included on the CD/DVD. This DICOM
CD/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 into
the drive). The St. Jude Medical DICOM Viewer may only be used to view St. Jude Medical generated DICOM images on a St. Jude Medical DICOM CD/DVD. If this CD/DVD
is to be used in a public forum, the Anonymous option should be used when exporting the
image using the system.
Viewer Controls
Directory Tree
File Viewer
Figure 8-5: St. Jude Medical DICOM Viewer - Image View
8-16
St. Jude Medical
Part Number ARTUS100088927
Exporting, Importing, and Managing Files
Using Exported Standard Format Recordings
The 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 contained in the DICOMDIR file on the CD/DVD. Individual images may be loaded by
clicking on the image item in the tree.
•
File Viewer - Provides two tabs:
•
Image tab - Displays the image currently selected in the DICOM Directory
Tree (see Figure 8-5). If the image is a recording, playback may be controlled
using 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 toolbar.
•
Attributes tab - Displays a list of all DICOM modules and attributes contained in the currently selected image (see Figure 8-6).
Figure 8-6: St. Jude Medical DICOM Viewer - Attributes View
ILUMIEN OPTIS System
Instructions for Use
8-17
Exporting, Importing, and Managing Files
Using Exported Standard Format Recordings
The 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 Object
Definition). The actual attributes contained in the file are listed in Table 8-2.
Table 8-2: DICOM File Attributes
Module
Patient
Attribute
Patient’s Name
Patient ID
Patient’s Birth Date
Patient’s Gender
General Study
Study Instance UID
Study Date
Study Time
Referring Physician’s Name
Study ID
Accession Number
Patient Study
Patient’s Age
General Series
Modality
Series Instance UID
Series Number
Series Date
Series Time
Body Part Examined
General Equipment
Manufacturer
Institution Name
Manufacturer Model Name
Software Version(s)
General Image
Instance Number
Patient Orientation
Content Date
Content Time
Image Type
Acquisition Date
Acquisition Time
Acquisition DateTime
Burned In Annotation
Image Comments
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St. Jude Medical
Part Number ARTUS100088927
Exporting, Importing, and Managing Files
Using Exported Standard Format Recordings
Table 8-2: DICOM File Attributes (continued)
Module
Attribute
Lossy Image Compression
Lossy Image Compression Ratio
Image Pixel
Pixel Data
SOP Common
SOP Class UID
SOP Instance UID
Instance Creation Date
Instance Creation Time
Timezone Offset from UTC
Instance Number
Multi-frame1
Frame Increment Pointer
Region Calibration
Sequence of Regions
Cine1
Frame Time
SC Equipment
Conversion Type
Modality
SC Device Manufacturer
SC Device Model Name
SC Device Software Version
SC Multi-frame Image1
Burned In Annotation
Frame Increment Pointer
1. Multi-frame files only.
ILUMIEN OPTIS System
Instructions for Use
8-19
Exporting, Importing, and Managing Files
Importing Files from a CD/DVD or USB
Importing Files from a CD/DVD or USB
1.
2.
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.
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).
Progress Bar and Message Area
Figure 8-7: Import Database Menu
8-20
St. Jude Medical
Part Number ARTUS100088927
Exporting, Importing, and Managing Files
Importing Files from a CD/DVD or USB
Table 8-3: Import Database Menu Options
Source 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 descending 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 ILUMOPTIS System.
IEN
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.
An import may require installation of several CD/DVDs. When a new disc is required, the
system ejects the current disc and displays a New Disc Request alert.
ILUMIEN OPTIS System
Instructions for Use
8-21
Exporting, Importing, and Managing Files
Importing Patient Information from a Remote DICOM Server
Importing Patient Information from a Remote DICOM Server
NOTE:
It is only possible to import patient information from a DICOM server.
You can not import and play DICOM images on the system. See the
DICOM sections in Chapter 10 “User Interface Reference” for more information on setting up connection to a DICOM server.
1.
Click the Settings button to open the Setup dialog box.
2.
Click the DICOM button to open the DICOM menu.
3.
In the Import Patient Information, click the Import button.
The Import from Remote DICOM Store menu (Figure 8-8) opens.
Figure 8-8: Import from Remote DICOM Store Menu
4.
8-22
Search for the patient whose information you wish to recall to the system.
•
Patient Name - Allows you to search by patient name. Patient names are formatted as the last name, comma, space and then the first name. This search
string is not case-sensitive. You can use ‘*’ to match any character or multiple
characters. A ‘?’ matches any single character. All other characters must be
explicitly matched. Leaving the text box empty will display all patients.
•
Patient ID - Allows you to search by patient IDs. Patient IDs on the Remote
DICOM Store are free-form text fields whose format is defined by the administrators of that system. Use the same special characters above to match
unknown characters. Leaving the text box empty will display all patients.
St. Jude Medical
Part Number ARTUS100088927
Exporting, Importing, and Managing Files
Importing Patient Information from a Remote DICOM Server
5.
Click the Search button.
6.
Select the patient or patients whose information you wish to import from the
Patient Information List. You can select multiple patients by holding the 
key and clicking the left mouse button. Use the Select All button to select all
patients listed.
NOTE:
An X in the checkbox next to the patient name indicates that patient
information already exists in the system’s database.
NOTE:
You can clear all selections in the patient list using the Clear All button.
7.
Click Import Selected to import the patient information for all selected patients
into the OCT database. If patient information is to be imported for a patient that
already exists in the database, then the information regarding that patient will be
verified as being accurate and updated if necessary (the information in the Remote
DICOM Store is always assumed to be more accurate).
8.
Click Done to close the menu.
ILUMIEN OPTIS System
Instructions for Use
8-23
Exporting, Importing, and Managing Files
Deleting Files
Deleting Files
You 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 been
deleted, they can only be imported back to your system from your
archived copies.
Deleting Files from the Patient Summary Menu
1.
In the Patient Summary menu, add a check to the checkbox of each file that you
want to delete (see Figure 8-4 on page 8-14).
A white border appears around each record that is selected.
2.
NOTE:
In the Patient Summary menu, you can select multiple files from
the same date, but not from different dates.
NOTE:
To deselect a file, clear the check from the checkbox. The check and
white border disappear to indicate that the file is no longer selected.
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.
8-24
Click Yes to delete the files, or click No to cancel the deletion and return to the
Patient Summary menu.
St. Jude Medical
Part Number ARTUS100088927
Exporting, Importing, and Managing Files
Deleting Files
Deleting Files from the Database Menu
1.
Click the Settings button to open the Setup dialog box.
2.
Click the Database button to open the Database menu (see Figure on page 10-6).
3.
Add a check to the checkbox of any recording to be deleted.
4.
•
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 recordings.
Click the Delete button.
A prompt asks you to confirm that you want to delete the selected files.
Figure 8-9: Deletion Warning Alert
5.
Click Yes to delete the files, or click No to cancel the deletion and return to the
Database menu.
ILUMIEN OPTIS System
Instructions for Use
8-25
Exporting, Importing, and Managing Files
Transfer and Import Messages
Transfer and Import Messages
The system displays a number of different messages to inform you of problems that may
arise during transfer and import operations.
Table 8-4: Transfer Messages
Error Message
Cause
Action
The 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 transfer and file deletion.
Some files did not fit on the
disc. Please insert another
writable CD/DVD to continue 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 writable 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 previously transferred, but the
remainder will not be transferred 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 interrupt 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 volume name.
Retype the name with acceptable characters.
Transfer failed, the destination The USB drive is full.
disk is full.
8-26
Connect a different USB
drive.
St. Jude Medical
Part Number ARTUS100088927
Exporting, Importing, and Managing Files
Transfer and Import Messages
Table 8-4: Transfer Messages (continued)
Error Message
Cause
Action
Transfer failed, the destination The CD/DVD already condisc is not blank.
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 transfer.
Transfer failed, the source or The USB drive is discondestination disk was removed. nected.
Reconnect the USB drive.
Please insert the next CD to
continue importing the database, 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 importing.
You have inserted a CD/DVD Insert another CD/DVD in the
containing files that have
series. or click Cancel to stop
already been imported.
the import.
Database not found. Please
The currently inserted
insert the next CD to continue CD/DVD does not include a
importing the database, or
valid OCT database file.
click Cancel to stop importing.
Insert a CD/DVD which contains 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 importing.
The currently inserted
CD/DVD includes a valid
OCT database file, but is not
in the same series as the previously 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 complete.
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 system. 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 database, or click Cancel to stop
importing.
Additional files exists on
another disc.
Insert the next disc. The message is automatically closed
and import continues.
ILUMIEN OPTIS System
Instructions for Use
8-27
Exporting, Importing, and Managing Files
Duplicate File Name Messages
Duplicate File Name Messages
Duplicate file name messages warn you when a file has been selected for export with the
same 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 files
with descriptive information, including the procedure or export date. To
resolve these errors when copying to CD/DVDs, insert another CD/DVD
into the drive and close the drive. File transfer resumes automatically. If
the transfer is cancelled, the uncopied files will remain on the hard drive.
Table 8-5: Duplicate File Name Messages
Message
Duplicate files could not be
written. Please insert a different CD/DVD to continue the
transfer, or click Cancel to
stop the transfer
Cause
Action
SOME of the file names in an Files with non-identical
export set are already found
names will be written to the
on the installed CD/DVD.
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 ALL the file names in an
with the same names. Please export set are already found
insert a different CD/DVD to on the installed CD/DVD.
continue the transfer, or click
Cancel to stop the transfer.
To save these files with these
file names, insert a new
CD/DVD and continue with
the transfer. To stop the transfer, click Cancel. This message may be displayed when
the Delete after transfer
checkbox in the Manage
Exported Files menu is
unchecked, leading to
re-exporting the same files.
Database Statistics
You can check the size and statistics of your system’s database using the Database Maintenance button in the Setup dialog box. See “Setup - Database/Maintenance Menu” on
page 10-7 for more information.
8-28
St. Jude Medical
Part Number ARTUS100088927
Cleaning & Maintenance
CAUTION: Only a qualified service representative can service components of the
system. Any attempt to open the system components by anyone other
than a qualified St. Jude Medical service representative will void the
warranty.
CAUTION: Do not perform cleaning or maintenance on the system in the patient
environment.
ILUMIEN OPTIS System
Instructions for Use
9-1
Cleaning & Maintenance
Contacting St. Jude Medical Service
Contacting St. Jude Medical Service
Service can be contacted at:
E-mail: OCTservice@sjm.com
Phone: +1 800 544 1664 (US)
+1 651 490 4410 (Outside US)
Cleaning
Cleaning of the ILUMIEN OPTIS System consists of:
9-2
•
Cleaning system surfaces.
•
Cleaning the DOC and its cable.
St. Jude Medical
Part Number ARTUS100088927
Cleaning & Maintenance
Cleaning
Routine Cleaning Procedure
The ILUMIEN OPTIS System should be cleaned following the facilities standard cleaning
schedule, or at least every 30 days under normal use.
1.
Turn off all system components with accessible power controls and unplug the
power cable.
2.
Clean system surfaces and the keyboard with a dry cloth, or a dry cloth slightly
dampened 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 cleaning solutions.
4.
Clean exposed system cables with a soft cloth moistened with water or a mild detergent.
5.
Clean the DOC and the DOC optical cable with a disinfectant wipe or Cidex (Glutaraldehyde 3.4%) and a soft cloth. Be particularly careful not to stress or sharply
bend the DOC optical cable.
NOTE:
Though enclosed in a bag during use, the DOC is the system component most exposed to dirt, fluids, and debris.
6.
Clean all other exposed system cables with a soft cloth moistened with water or
water and a mild detergent.
7.
Clean the air filter on the system as specified in “Air Filter Maintenance Procedure”.
ILUMIEN OPTIS System
Instructions for Use
9-3
Cleaning & Maintenance
Maintenance
Maintenance
Maintenance of the system consists of:
9-4
•
Cleaning the optical connection in the DOC and the Dragonfly™ Imaging Catheter.
•
Replacing the optical adapter in the DOC.
•
Cleaning or replacing the air filter.
•
Inspecting exposed cable connections.
•
Transferring log files.
•
Identifying the installed software version.
St. Jude Medical
Part Number ARTUS100088927
Cleaning & Maintenance
Maintenance
Optical Connection Cleaning Procedure
The optical connection between the DOC and the Dragonfly™ Imaging Catheter should
be cleaned whenever there is a loss of image quality. Image quality should also be
checked 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 a
sterile catheter.
NOTE:
Before beginning this procedure ensure that you have the St. Jude Medical
Optical Fiber Connector Cleaner available.
NOTE:
Do not touch any of the optical connectors or the end of the Optical Fiber
Connector Cleaner as this may damage them.
1.
If a catheter is connected to the DOC, press the Unload button on the DOC and wait
until the “lock” LED stops flashing. Once the “lock” LED is off, remove the catheter.
2.
Click the Setup button and select the Service menu.
3.
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 position for 1 minute. Rotation of the DOC rotary motor is stopped and the laser source
is turned off.
4.
Remove the sizing cap from the end of the Optical Fiber Connector Cleaner (see
Figure 9-1).
5.
Insert the cleaner into the center of the Optical Adapter in the DOC, ensuring it
seats fully, and press until it clicks.
ILUMIEN OPTIS System
Instructions for Use
9-5
Cleaning & Maintenance
Maintenance
The cleaning material in the Optical Fiber Connector Cleaner is moved over the
optical connection cleaning it.
Figure 9-1: Inserting Cleaner Into Optical Adapter
6.
Remove the cleaner from the DOC.
7.
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 are
returned to their normal state.
8.
Click on OK or Cancel to close the Setup dialog box.
9.
Open the sizing cap and place it on the end of the Optical Fiber Connector Cleaner
(see Figure 9-2).
10.
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 the
optical connection cleaning it.
9-6
St. Jude Medical
Part Number ARTUS100088927
Cleaning & Maintenance
Maintenance
Figure 9-2: Inserting Cleaner Into Catheter
11.
Remove the cleaner from the Dragonfly.
12.
Reconnect the Dragonfly Imaging Catheter to the DOC.
13.
Return the system to normal operation.
ILUMIEN OPTIS System
Instructions for Use
9-7
Cleaning & Maintenance
Maintenance
Optical Adapter Replacement Procedure
The Optical Adapter should be replaced every 200 cycles or 1 year (which ever comes
first), or if cleaning (see “Optical Connection Cleaning Procedure”) does not improve the
image 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 wait
until the “lock” LED stops flashing. Once the “lock” LED is off, remove the catheter.
2.
Click the Setup button and select the Service menu.
3.
In the DOC Service section of the Service menu, click the Enter button.
4.
Click on the Enter DOC Service button.
The DOC optical carriage moves all the way to the front and then locks into position for 1 minute. Rotation of the DOC rotary motor is stopped and the laser source
is turned off.
5.
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
6.
9-8
Pull the adapter straight out of the DOC.
St. Jude Medical
Part Number ARTUS100088927
Cleaning & Maintenance
Maintenance
NOTE:
7.
Ensure that the adapter does not rotate while it is being removed as
this could damage the DOC or break the adapter.
Remove the cap and plug from the replacement Optical Adapter.
NOTE:
8.
Do not touch any of the optical connectors as this may damage them.
Using your fingers, align the new adapter with the DOC, ensuring the key is aligned
with 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 Exit
button in the DOC Service section of the Service menu. Once it
changes to Enter, click it again. Once the optical carriage is locked
into position at the front of the DOC firmly press the adapter into
place.
Key Slot
Optical Carriage
Figure 9-4: Alignment of Optical Adapter with Optical Carriage
9.
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 functions to their normal state.
10.
Click on OK or Cancel to close the Setup dialog box.
11.
Return the system to normal operation.
ILUMIEN OPTIS System
Instructions for Use
9-9
Cleaning & Maintenance
Maintenance
Air Filter Maintenance Procedure
The air filter should be cleaned every 6 months under normal use.
1.
Locate the air filter holder at the bottom of the cart (refer to Figure 1-2 on page 1-5).
2.
Pull the filter holder out of the cart base.
3.
Remove the filter and brush or vacuum off dust (replace if necessary).
4.
Place the filter into the filter holder.
5.
Push the filter holder back into the cart base.
Cable Connection Inspection Procedure
9-10
1.
Ensure the power connection to the system is fully seated and secured with the
strain-relief clip.
2.
If a secondary ground connection is being used, ensure that both ends of the cable
are secure.
3.
Ensure all other connectors are fully seated and properly secured.
St. Jude Medical
Part Number ARTUS100088927
Cleaning & Maintenance
Maintenance
Transferring Log Files
Log files may be transferred to a CD or external USB device so that you can archive them
or E-mail them to St. Jude Medical Service.
Figure 9-5: Transfer Event Log Files Menu
NOTE:
When there are multiple repeated events of the same type the event logs
are 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 Settings button to open the Setup dialog box.
2.
Click the Service button to open the Service menu.
3.
In the Service Log area, click the Export button.
The Transfer Event Log Files menu opens (Figure 9-5), which lists all the files to
be 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 large
enough 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 Label
field.
ILUMIEN OPTIS System
Instructions for Use
9-11
Cleaning & Maintenance
Maintenance
•
Click External Drive to export to an external USB device.
If necessary, click the External Drive selection box to select the correct drive
location from the drop-down menu.
Click the Ellipsis (...) button to the right of the Path selection box to browse
for a specific folder on the device.
5.
9-12
Click the Transfer button to transfer the files or Cancel to cancel the operation.
St. Jude Medical
Part Number ARTUS100088927
Cleaning & Maintenance
Infection Control
Identifying the Software Version
The Startup window (Figure 9-6) shows the version and copyright information for the
system. If the system is running, type  to open the Startup window. The software
version information might be required when contacting St. Jude Medical Service.
Figure 9-6: System Startup Window
Infection Control
Follow the infection control procedures established in your institution for protection of
both staff and patient.
Blood on system components, panels, and cables should be removed by using a gauze pad
with soap and water, and drying with a soft cloth to prevent corrosion. The DOC cable can
be cleaned with a disinfectant wipe or Cidex and a soft cloth.
ILUMIEN OPTIS System
Instructions for Use
9-13
Cleaning & Maintenance
User Troubleshooting
User Troubleshooting
Table 9-1 provides basic guidelines for troubleshooting the ILUMIEN OPTIS System.
“Troubleshooting OCT Acquisition” on page 5-18 explains what to do if a catheter fails
during pullback.
If your problem is not resolved after attempting the suggested remedies, contact your service representative or E-mail OCTservice@sjm.com.
Table 9-1: User Troubleshooting Tips
Symptom
Possible Causes
Remedy
General
Screen blank, power Display not turned on.
indicator on monitor not lit.
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 connected 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 PC auto-boot failed.
indicator on monitor lit.
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.
Connections
During data export,
the system does not
list the USB drive
plugged into the
USB port.
9-14
The connected USB
drive is not compatible
with the system, or the
USB drive requires formatting.
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.
St. Jude Medical
Part Number ARTUS100088927
Cleaning & Maintenance
User Troubleshooting
Table 9-1: User Troubleshooting Tips (continued)
Symptom
Screen message
“Imaging engine initialization failed” is
displayed at startup.
Possible Causes
Remedy
This message can be
caused by several problems, including loose or
damaged system connections.
Shut down the system, turn off the main
system power, and wait 15 seconds. Then
turn the system back on. If the error is displayed again, contact your St. Jude Medical
service representative for instructions.
DOC
Optical fiber does
The Stop button on the Check screen for message and follow
not rotate when Live DOC was pressed.
instructions.
View is pressed.
Imaging catheter defec- Replace imaging catheter.
tive, optical fiber does
not rotate.
DOC makes excessive noise without
imaging catheter
connected.
DOC mechanism failure.
Contact your service representative to
obtain a replacement DOC.
Monitor contrast and
brightness set incorrectly.
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.
Imaging
OCT image dim,
with no background
noise visible.
Defective imaging cath- Remove imaging catheter from DOC. If
eter causing system sat- background noise appears, the imaging
uration.
catheter is defective. Replace catheter.
Dirty connection
between DOC and
imaging catheter.
ILUMIEN OPTIS System
Instructions for Use
Refer to “Optical Connection Cleaning
Procedure” on page 9-5 to clean the connection.
9-15
Cleaning & Maintenance
System Disposal
System Disposal
Disposal of the equipment must be in accordance with local laws.
9-16
St. Jude Medical
Part Number ARTUS100088927
User Interface Reference
10
Setup Dialog Box and Submenus
The Setup dialog box provides access to all of the configuration and service functions for
the system. The Setup dialog box is accessed through the Settings button on the Select
Patient or Patient Summary menus.
NOTE:
When creating or reviewing an OCT recording, the Settings button opens
a 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 the
bottom of the dialog box.
Table 10-1: Setup Dialog Box Common Options
Refresh
Click to updates 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.
ILUMIEN OPTIS System
Instructions for Use
10-1
User Interface Reference
Setup - Acquisition Menu
Setup - Acquisition Menu
Figure 10-1: Setup - Acquisition Menu
Table 10-2: Setup - Acquisition Menu Settings
Sets the recording type for image acquisition:
Recording Type
Pullback - Performs a recording while the imaging
core of the catheter is pulled back within the catheter 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.
Sets the Pullback trigger type to use for image
acquisition:
Trigger Type
Automatic - The system automatically begins a
recording when it detects that the vessel has been
cleared by the flush injection.
Sets the pullback speed.
Pullback Speed
NOTE: When connected to an original C7 Dragonfly imaging catheter, the Pullback
Speed settings are limited to 10.0
mm/sec, 20.0 mm/sec, and 25.0 mm/sec.
Sets the length of the pullback.
Pullback Length
10-2
NOTE: When connected to an original C7 Dragonfly imaging catheter, the Pullback
Length setting is limited to 54 mm.
St. Jude Medical
Part Number ARTUS100088927
User Interface Reference
Setup - Acquisition Menu
Table 10-2: Setup - Acquisition Menu Settings (continued)
NOTE: This setting is unavailable if a catheter
has already been connected.
Imaging Catheter Type
Sets the type of imaging catheter being used.
NOTE: Only Dragonfly imaging catheters are
approved for use with the ILUMIEN OPTIS
System for cardiovascular imaging.
Guided Workflow
ILUMIEN OPTIS System
Instructions for Use
Turns on and off the appearance of the purge catheter guidance message.
10-3
User Interface Reference
Setup - Acquisition/Other Menu
Setup - Acquisition/Other Menu
Figure 10-2: Setup - Acquisition/Other Menu
Table 10-3: Setup - Acquisition/Other Menu Settings
Controls 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.
Flush Medium
Unchecked - All configured contrast options are
available for selection in the Flush Medium
drop-down box.
NOTE: To change the Flush Medium setting
before performing an OCT recording, see
“Confirm Recording Settings” on page
5-10.
10-4
St. Jude Medical
Part Number ARTUS100088927
User Interface Reference
Setup - Administration Menu
Setup - Administration Menu
Figure 10-3: Setup - Administration Menu
Table 10-4: Setup - Administration Menu Settings
Institution Name
Click here and enter or clear the institution name.
Date and Time
Opens the system Date and Time Properties menu.
Resets all user-entered configuration values except the
date and time to the original factory default values.
Default Settings
CAUTION: Restoring factory default settings resets
ALL user-entered configuration values
except the date and time. This button
should be used only by qualified service
personnel or under their direction.
System Information
Displays current date, system name, institution name, and
software version
Legal Notices
Displays legal notices of the system.
ILUMIEN OPTIS System
Instructions for Use
10-5
User Interface Reference
Setup - Database Menu
Setup - Database Menu
The Database menu in the Setup dialog box shows a list of all files in the database. From
this 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 recordings
for that patient, or click on the database to select all recordings.
Figure 10-4: Setup - Database Menu
Table 10-5: Setup - Database Menu Settings
10-6
Database 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.
Edit Patient...
Click on a patient’s name to edit the patient’s information. See “Editing Patient Information” on page 3-6 for more information.
Anonymize...
Click on a patient’s name to remove the patient’s identifying information from the record. See “Exporting Files in Native (Raw) Format”,
Step 3, on page 8-8, for an explanation of the anonymization function.
St. Jude Medical
Part Number ARTUS100088927
User Interface Reference
Setup - Database/Maintenance Menu
Setup - Database/Maintenance Menu
You can check the status of the system’s OCT database using the Database Maintenance
menu in the Setup dialog box. From this menu, you can check the size of the database
file, as well as the number of files referenced by the database and the combined size of
these files. This menu also warns you of possible issues found with files in the system’s
database.
Figure 10-5: Setup - Database/Maintenance Menu
Table 10-6: Setup - Database/Maintenance Menu Settings
Disk Usage
Provides both a graphic and text showing the
amount of free and used space on the system’s hard
disk.
Database File
Indicates the size of the database file.
Missing Images
OCT image files that are referenced by the database but could not be found. Click the Clean button to remove references to files that cannot be
found.
Missing and Low Resolution
Thumbnails
Thumbnail image files that are missing or are low
resolution. Click the Generate button to generate
new thumbnail image files.
Orphaned Images
OCT 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.
ILUMIEN OPTIS System
Instructions for Use
10-7
User Interface Reference
Setup - Database/Physician Menu
Setup - Database/Physician Menu
Figure 10-6: Setup - Database/Physician Menu
Table 10-7: Setup - Database/Physician Settings
Physician 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.
10-8
St. Jude Medical
Part Number ARTUS100088927
User Interface Reference
Setup - DICOM Menu
Setup - DICOM Menu
The DICOM menus in the Setup dialog box are used to configure the network settings of
the system and the Remote DICOM Store so that the system can initiate a network connection between the two systems. If multiple network adapters exist on the system (not a
St. Jude Medical standard configuration) only the primary network adapter can be used.
CAUTION: The ILUMIEN OPTIS System should only be connected to a secure
intranet. Direct connection to the Internet may interfere with correct
operation and/or result in inappropriate access to patient information,
and voids system warranties.
Please note St. Jude Medical makes no representation or warranty
that use of the ILUMIEN OPTIS System complies with applicable privacy, security and confidentiality laws, but encourages you to assess
your own risk as you use, disclose, control, process or transfer patient
health information with the system.
It is strongly recommended you contact your IT department to set up the system on the
DICOM server. Refer to the St. Jude Medical DICOM Conformance Statement for more
information on configuration.
Figure 10-7: Setup - DICOM Menu
ILUMIEN OPTIS System
Instructions for Use
10-9
User Interface Reference
Setup - DICOM Menu
Table 10-8: Setup - DICOM Menu Settings
Local AE Title
The AE (Application Entity) title used to configure the Local
DICOM Store SCU (Service Class User) used by the ILUMIEN OPTIS System.
Remote AE Title
The AE title used to configure the Remote DICOM Store
SCP (Service Class Provider) to which the system connects.
Remote Port
The port number on which the Remote DICOM Store Host
will be listening for connection requests. The default is 104.
Response Timeout (secs)
The maximum time to allow for a response from the Remote
DICOM Store after sending a DICOM request. The minimum 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 Store SCP. For a successful test:
• A TCP/IP connection is successfully made from the system 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-Frame
True Color Secondary Capture, a warning message
appears, telling you to use SC-Image-Storage SOP
class instead. If the DICOM server supports neither
the Multi-Frame True Color Secondary Capture nor
Secondary Capture, a warning message appears:
"The presentation syntax supported by the remote
server is not compatible. Images cannot be
exported to the remote DICOM server."
NOTE: The Test Connection button is unavailable if the
Obtain an IP Address Automatically checkbox is
checked. See “Setup - DICOM/Local Host Menu”
on page 10-12.
Import Patient
Information from
DICOM Store
10-10
Click on the Import button to import patient information
from a Remote DICOM Store into the database.
St. Jude Medical
Part Number ARTUS100088927
User Interface Reference
Setup - DICOM/Image Options Menu
Setup - DICOM/Image Options Menu
Figure 10-8: Setup - DICOM/Image Options Menu
Table 10-9: Setup - DICOM/Image Options Menu Settings
SC-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.
SOP Class
SC-Image-Storage SOP: When this button is
selected, DICOM images are exported as Single-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.
Modality
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
information
If this box is checked, region calibration information is not included in the DICOM data.
ILUMIEN OPTIS System
Instructions for Use
10-11
User Interface Reference
Setup - DICOM/Local Host Menu
Setup - DICOM/Local Host Menu
Figure 10-9: Setup - DICOM/Local Host Menu
Table 10-10: Setup - DICOM/Local Host Menu Settings
Hostname
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 on
the network may cause network instability.
Subnet 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 determined 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
Automatically
When 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, Subnet Mask, and Gateway.
10-12
St. Jude Medical
Part Number ARTUS100088927
User Interface Reference
Setup - DICOM/Remote Host Menu
Setup - DICOM/Remote Host Menu
Figure 10-10: Setup - DICOM/Remote Host Menu
Table 10-11: Setup - DICOM/Remote Host Menu Settings
Hostname
The host name of the network server that contains the Remote
DICOM Store. Use this option to identify the server if the network
supports the Domain Name System (DNS) and the host name is
known; otherwise, use the Remote IP Address (see below).
IP Address
The IP address of the network server that contains the Remote
DICOM Store. If the Remote Hostname is used to identify the
server, this field is automatically filled in if the Ping Host button
(see below) is successfully used to verify the network connection.
Check the Specify checkbox to explicitly specify the remote IP
address.
Network Timeout
The maximum time to allow for a network ping response from the
network server that contains the Remote DICOM Store. The
default is 15 seconds.
Ping Host
Use this button to test the network connection between the ILUMIEN
OPTIS System and the Remote DICOM Store Host. An ICMP Echo
request message is used to verify the connection.
NOTE: The Test Connection button is unavailable if the Obtain
an IP Address Automatically checkbox is checked. See
“Setup - DICOM/Local Host Menu” on page 10-12.
ILUMIEN OPTIS System
Instructions for Use
10-13
User Interface Reference
Setup - Display Menu
Setup - Display Menu
Figure 10-11: Setup - Display Menu
Table 10-12: Setup - Display Menu Settings
Check this checkbox to add graduated marks to the cut plane indicators.
Graduated Cut
Plane
Check this checkbox to add crosshairs to the cross section view.
Crosshair On/Off
10-14
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.
St. Jude Medical
Part Number ARTUS100088927
User Interface Reference
Setup - Display/3D Option Menu
Setup - Display/3D Option Menu
Figure 10-12: Setup - Display/3D Option Menu
Table 10-13: Setup - Display/3D Option Menu Settings
Default Playback Mode is 3D
3D Display Modes
ILUMIEN OPTIS System
Instructions for Use
Turns 3D Display on by default for all pullback recordings.
Click to select which display options are available when
using 3D.
NOTE: Segmented Lumen is not available when the
Automatic MLA and %DS option is disabled.
10-15
User Interface Reference
Setup - FFR
Setup - FFR
Figure 10-13: Setup - FFR Menu
Table 10-14: Setup - FFR Menu Settings
10-16
Manage Rooms
The table lists all Wi-Box receivers that have been added to this
ILUMIEN OPTIS System. Click an entry and press Delete to remove
it from the system.
Demonstration
Mode
Click to select the source of data that the system uses when in
Demonstration Mode for FFR.
St. Jude Medical
Part Number ARTUS100088927
User Interface Reference
Setup - Measurements Menu
Setup - Measurements Menu
Figure 10-14: Setup - Measurements Menu
Table 10-15: Setup - Measurements Menu Settings
Pen Color
List of pen colors that can be used for subsequent measurements and
calculations. If Auto Cycle is selected, the pen color used for measurements is automatically changed to the next color after a new measurement is completed.
Line Width
List of line widths that can be used for subsequent measurements and
calculations. The default is 1 pt.
Control Point
Size
List of point sizes that can be used for subsequent length and two-point
circular area measurements. The default is Medium.
ILUMIEN OPTIS System
Instructions for Use
10-17
User Interface Reference
Setup - Measurements/Labels Menu
Setup - Measurements/Labels Menu
Figure 10-15: Setup - Measurements/Labels Menu
Table 10-16: Setup - Measurements/Labels Menu Settings
Default Labels
Label text that will be used when making the indicated type of measurement.
Click and type in any field to change that label.
10-18
St. Jude Medical
Part Number ARTUS100088927
User Interface Reference
Setup - Options Menu
Setup - Options Menu
The Options menu in the Setup dialog box is used to enable or disable system options
Figure 10-16: Setup - Options Menu
Table 10-17: Setup - Options Menu Settings
System ID
Show Options
Option List
ILUMIEN OPTIS System
Instructions for Use
The ID of this system.
Click to show the list of available options.
A password is required to show the option list.
System options that may be purchased for this system.
A password is required to change option settings.
10-19
User Interface Reference
Setup - Print Menu
Setup - Print Menu
Figure 10-17: Setup - Print Menu
Table 10-18: Setup - Print Menu Settings
USB File Format
10-20
Click to choose the format used when printing a file to a USB
drive.
St. Jude Medical
Part Number ARTUS100088927
User Interface Reference
Setup - Service Menu
Setup - Service Menu
The Service menu in the Setup dialog box displays service logs to help St. Jude Medical
Service analyze problems which may occur during system operation. If you encounter
problems while using the system, you may be asked to access and report information from
this menu.
Figure 10-18: Setup - Service Menu
Table 10-19: Setup - Service Menu Settings
Click the View button to open the Service Event Viewer.
Buttons
Headers
Service Log
(View)
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 categories of information:
• Errors - lists all the operating errors logged by the system.
• Warnings - lists all the Warning prompts displayed during operation.
• 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.
ILUMIEN OPTIS System
Instructions for Use
10-21
User Interface Reference
Setup - Service Menu
Table 10-19: Setup - Service Menu Settings (continued)
Service Log
(Export)
Operating Mode
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.
Click 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.
Click Launch to start the Field Service Utility.
Field Service Tool
NOTE: The service utility is for use by trained Field Service Engineers.
A password is required to open the service utility.
External Monitor
Calibration
Options
Click Enable to activate the Video connector on the System Connector Panel (see “Ilumien Optis System - Connector Panel” on page
1-6). Once enabled, you can connect an external VGA monitor to the
system. Contact St. Jude Medical to have this option enabled.
The Hide Calibration checkbox controls the display of the calibration sequence when a catheter is first connected to the DOC.
Checked - The calibration sequence is hidden.
Unchecked - The calibration sequence is displayed on screen.
10-22
St. Jude Medical
Part Number ARTUS100088927
User Interface Reference
Setup - Service/System Diagnostics Menu
Setup - Service/System Diagnostics Menu
The System Diagnostics menu in the Setup dialog box is provided to help St. Jude Medical Service monitor and analyze signal levels in the imaging engine either in real time or
at the time a recording was made. When the tab is selected the system immediately displays the detected signal levels while in Acquisition mode or the signal values when the
current image was captured when in Playback mode. If you encounter problems while
using the system, you may be asked to access and report information from this tab
Figure 10-19: Setup - Service/System Diagnostics Menu
Table 10-20: Setup - Service/System Diagnostics Menu Settings
Power 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.
SLC
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 milliseconds.
NOTE: During playback, the Polling button is disabled, and the values
represent the signal levels of the imaging engine at the image
recording time.
ILUMIEN OPTIS System
Instructions for Use
10-23
User Interface Reference
Setup - Service/System Diagnostics Menu
10-24
St. Jude Medical
Part Number ARTUS100088927
Safety Information
11
Although the ILUMIEN OPTIS System conforms to laser emission standards and both international and European safety and electromagnetic compatibility standards, the system is
intended for use only by medical personnel who have received ILUMIEN OPTIS System
training. Only a trained operator can determine if ILUMIEN OPTIS System use is appropriate. An awareness of the system’s limitations is essential to making that determination
and 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 to
read and understand all of the information in this chapter.
NOTE:
The ILUMIEN OPTIS System complies with FDA performance standards for
laser products except for deviations pursuant to laser Notice No. 50, dated
July 26, 2001.
ILUMIEN OPTIS System
Instructions for Use
11-1
Safety Information
Patient Safety
Patient Safety
The ILUMIEN OPTIS System is intended for use only by medical personnel trained in its
operation 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 OPTIS
System. Use of other types of catheters may result in unsafe conditions
for the patient and damage the ILUMIEN OPTIS System.
General
WARNING: Failure to follow the guidelines described in these Instructions for Use
and in the Instructions for Use provided with the accessories may
result in injury to patients and damage to equipment.
•
Only use Dragonfly™ Imaging Catheters. Always use under appropriate imaging
guidance (endoscopy, x-ray fluoroscopy, or other appropriate guidance method).
•
Only use PressureWire pressure transducers to report aortic distal pressure. Always
use under appropriate imaging guidance (endoscopy, x-ray fluoroscopy, or other
appropriate guidance method).
•
Always read and follow the Instructions for Use supplied with the Dragonfly Imaging Catheter and with the PressureWire catheter.
•
Always use controls, make adjustments and perform procedures as specified in
these Instructions for Use.
Techniques to Minimize Patient Exposure
The ILUMIEN OPTIS System meets the performance standards of laser-emitting products
as established by IEC 60825-1. Although no harmful effects have been demonstrated for
the near-infrared light wavelengths, intensities, and exposure times used during examinations with the ILUMIEN OPTIS System, St. Jude Medical recommends that you carefully
read the warning labels on the system (see Figure 11-1) and follow these examination
guidelines:
11-2
•
Use OCT only when there is a good reason to do so.
•
Use techniques that enable quick collection of clinical data and shorten procedure
time.
St. Jude Medical
Part Number ARTUS100088927
Safety Information
Operator Safety
Operator Safety
Avoiding Operator Light Emission Hazards
To avoid any potential light emission hazards to yourself or patients, adhere to the information provided in the safety labels that are located on the system (see Figure 11-1), and
observe the precautions outlined in this section.
WARNING: Failure to follow any of these precautions may cause possible serious
damage to your eyes.
Figure 11-1: Connector Panel Laser Safety Labels
•
Avoid eye exposure. Do not look at or stare directly into the beam. Doing so may
damage your eyes.
•
Never view the laser output with optical instruments (for example, eye loupes, magnifiers, and microscopes). Doing so may damage your eyes.
•
Use controls, make adjustments, and perform procedures only as specified in these
Instructions for Use.
Repetitive Strain Injury (RSI)
Repetitive use of a mouse and keyboard has been associated with Carpal Tunnel Syndrome (CTS) and related musculoskeletal problems. Follow these suggestions to help
prevent 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 and
repetitive movements.
ILUMIEN OPTIS System
Instructions for Use
11-3
Safety Information
Moving the System
Moving the System
When moving the system, observe these precautions:
WARNING: Failure to follow any of these precautions may lead to a system tipping
hazard, 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 beginning 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 people
are required when moving it.
•
Make sure that the system’s wheels roll freely before beginning the move. Resolve
any wheel problems before you move the system.
NOTE:
•
To eliminate the potential danger of the system’s tipping over, avoid ramps that are
steeper 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 5
degrees, use two people.
•
Do NOT lift a cart bearing the system to move it over uneven elevator entrances or
other steps and barriers. Instead, find a route that avoids such problems.
NOTE:
11-4
Be sure the system brakes are in the up position (unlocked).
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 system
components plus passengers.
•
If a lift is used be sure the load capacity of the lift can accommodate the weight of
the system components plus passengers.
St. Jude Medical
Part Number ARTUS100088927
Safety Information
Avoiding Electrical Hazards
Avoiding Electrical Hazards
The isolation transformer in the ILUMIEN OPTIS System provides electrically isolated
power to components supplied with the system or specified as part of the system.
WARNING: All system components except the isolation transformer itself MUST
be powered by, and only by, the isolation transformer in the ILUMIEN
OPTIS System.
This electrical isolation separates the system components, and thus the patient, from dangerous leakage currents. If any of the system’s components are directly connected to a
wall outlet or some power source other than the isolation transformer, the patient and the
operator are no longer safely isolated and may be exposed to dangerous electric currents.
WARNING: Failure to abide by the precautions detailed below causes the system
and its use to be out of compliance with regulations and places the
patient and the operator at risk of injury or death.
•
Do NOT use additional cables, extension cords or outlets with the ILUMIEN OPTIS
System.
NOTE:
•
The ILUMIEN OPTIS System’s isolation transformer creates an electrically isolated Patient Interface for invasive imaging. This electrically isolated condition must be maintained throughout the
procedure or during any contact with the patient.
When transferring files inside the catheterization lab, use only port-powered USB
drives.
WARNING: Inside the catheterization lab only port-powered USB drives
may be connected to the USB port. Connecting externally powered devices to the USB port in the patient vicinity may compromise electrical isolation and cause patient injury.
NOTE:
•
Outside the catheterization lab, IEC 60950-compliant, externally
powered USB hard drives may be connected to the USB port.
Do NOT remove system covers. Only qualified personnel should service the system. Accidentally contacting the electrical circuits inside the housing could cause
serious injury.
ILUMIEN OPTIS System
Instructions for Use
11-5
Safety Information
Making Proper Electrical Connections
Making Proper Electrical Connections
Ensure the electrical connection for the system is properly rated (see Figure 11-2). Carefully follow the safety guidelines described in this section when connecting your system’s
power cord to the hospital or lab’s AC outlet.
WARNING: Failure to follow the electrical connection precautions detailed in this
section causes the system and its use to be out of compliance with regulations and places the patient and the operator at risk of injury or
death and may damage the equipment.
Figure 11-2: Electrical Label
•
Connect the system only to properly grounded (three-hole) hospital-grade AC outlets:
•
The circuit must accommodate an additional load of up to 400 VA.
•
Replacement fuses are available through St. Jude Medical, part number: 11559-02
FUSE
•
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 ILUMIEN
OPTIS System comply with the appropriate IEC/national standard and are certified
to IEC 60950.
•
Use no electrical peripherals within six feet of a patient unless the peripherals
receive power from an isolation transformer that meets medical safety standards.
NOTE:
11-6
If the ILUMIEN OPTIS System is used with peripherals that are powered from a separate wall outlet, then the combination is considered
to be a Medical System. It is the user’s responsibility to comply with
IEC 60601-1-1 and test the Medical System according to the requirements.
St. Jude Medical
Part Number ARTUS100088927
Safety Information
Explosion Hazard
Explosion Hazard
WARNING: Do NOT operate the ILUMIEN OPTIS System in the presence of flammable anesthetics. Doing so could lead to an explosion.
System Imaging Limitations
The ILUMIEN OPTIS System is intended for use by medical personnel who have received
training in the use of the system. To determine if system use is appropriate, the trained
user must be aware of system imaging limitations.
CAUTION: Use only the Dragonfly™ Imaging catheters with the ILUMIEN OPTIS
System. Other types of catheters may break if used.
This section includes information about system capabilities and limitations for both vessel and tissue imaging.
Considerations for Optimal Vessel Imaging
The ILUMIEN OPTIS System can be used to image through vessels or to image the inner
surface of certain vessels. Since the Dragonfly catheter is smaller than the diameter of the
vessel being imaged, the position of the catheter in the vessel has an effect on the portion
of 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 Imaging
The maximum imaging depth within a vessel wall ranges from approximately 0.9 mm to
1.3 mm and is limited by optical attenuation caused by scattering of the optical beam by
microstructures in the vessel. For example, penetration of the OCT beam is deepest in calcified tissue and shallowest in dense fibrotic tissue.
ILUMIEN OPTIS System
Instructions for Use
11-7
Safety Information
Electromagnetic Compatibility
Electromagnetic Compatibility
The ILUMIEN OPTIS System is designed to meet the following electromagnetic compatibility standards:
•
IEC 60601-1-2 (International).
•
EN 60601-1-2 (Europe).
Electromagnetic Interference
The system produce images by using digital signal processing techniques that operate in
the radio frequency (RF) energy range. The system is therefore susceptible to interference
generated by other RF energy sources such as medical devices, information technology
products, or radio/television transmission towers. Tracing the source of radiated interference can be difficult.
In accordance with the standards identified in these Instructions for Use, no interference
was observed. However, the trained user must determine if an artifact caused by radiated
interference 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 facility? Examples: Placing the system close to an ECG cable can increase electromagnetic interference. Moving the cable or other medical equipment away from the
system can reduce electromagnetic interference.
Please answer these questions before contacting your service representative. The answers
will help a service representative determine if the problem is in the system or in the imaging environment.
11-8
St. Jude Medical
Part Number ARTUS100088927
Safety Information
Safety Functions Built Into the Ilumien Optis System
Safety Functions Built Into the ILUMIEN OPTIS System
The 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 1-9).
ILUMIEN OPTIS System
Instructions for Use
11-9
Safety Information
Safety Functions Built Into the Ilumien Optis System
11-10
St. Jude Medical
Part Number ARTUS100088927
System Specifications
12
System - Safety & Regulatory
Table 12-1: System Safety & Regulatory Specifications
Category
Specifications
Regulatory Approvals
Safety standards system
meets
EN60601-1: 1990, “Medical Electrical Equipment, Part 1:
General Requirements for Safety” including Amendments
A1:1993, A2:1995, A13:1996
EN60601-1-1: 2001, “Medical Electrical Equipment, Part 1:
General Requirements for Safety - Section 1.1 Safety Requirements for Medical Electrical Systems”
EN60601-1-1: 2005, Ed: 3, “Medical Electrical Equipment,
Part 1: General Requirements for Basic Safety and Essential
Performance”
EN60601-1-2: 2007, Electromagnetic Radiated Emissions
Requirements for Medical Electrical Equipment - Group 1
Equipment, Class B for Non-Life Supporting Equipment
UL60601-1, “Medical Electrical Equipment, Part 1: General
Requirements for Safety” 2nd Edition, including Amendments
A1 and A2
CAN/CSA C22.2 No. 601.1-M90, “Medical Electrical Equipment, Part 1: General Requirements for Safety” including
C22.2 No. 601.1S1-94 (IEC 601-1, Amendment 1:1991)
IEC 60825-1, 2nd Ed., 2007: Safety of Laser Products
Electromagnetic compatibility (EMC)
ILUMIEN OPTIS System
Instructions for Use
Refer to Table 12-5, Table 12-6, Table 12-7, and Table 12-8
for detailed specifications.
12-1
System Specifications
System - Safety & Regulatory
Table 12-1: System Safety & Regulatory Specifications (continued)
Category
Specifications
Classifications
Type of protection, shock
Class 1
Degree of protection,
shock
Type CF
• DOC with catheter (CF label at DOC cable exit on Connector Panel)
Degree of protection,
ingress
Console - IPX0
Method of Disinfection
Console and DOC will withstand without damage or deterioration disinfection by wiping with common hospital disinfectants 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
Continuous
DOC - IPX0, use with Sterile DOC cover for ingress protection
Leakage & Auxiliary Current
Chassis leakage current
< 100 µa rms normal condition
< 500 µa rms single-fault condition
Patient leakage current
Measured at patient end of DOC:
< 10 µa rms normal condition
< 50 µa rms single-fault condition
Software Safety Features
The 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.
12-2
St. Jude Medical
Part Number ARTUS100088927
System Specifications
System - Electrical and Physical
System - Electrical and Physical
Table 12-2: System Electrical and Physical Specifications
Parameter
Specification
Power Input
Line voltage
100/120/220/240 VAC ±10%, user selectable
50/60 Hz ±1 Hz
Power consumption
Active: < 400 VA
Standby: < 30 VA
Transport and Storage Conditions (Permissible ranges)
Ambient temp
-25 to +50 degrees C
Relative humidity
10% - 95%, including condensing
Atmospheric pressure
500 to 1060 mBar
Operating Conditions
Ambient temperature
+10 to +32 degrees C
Relative humidity
30% to 80%, non-condensing
Atmospheric pressure
700 to 1060 mBar
Mechanical Specifications
Weight
95 kg (209 lbs) max with all accessories
Overall Dimensions
145 cm H x 61 cm W x 71 cm D ±5 mm
ILUMIEN OPTIS System
Instructions for Use
12-3
System Specifications
Imaging Specifications
Imaging Specifications
Table 12-3: Imaging Specifications
Parameter
Specification
Optical 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 2M Laser Output per IEC 60825-1)
Pullback Parameters
Pullback 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 settings are 10.0 mm/sec, 20.0 mm/sec, 25.0 mm/sec.)
General Scan Parameters
A-Scan Range in Air
7.0 mm
A-Scan Range in Contrast
4.83 mm
Diameter Measurement Accuracy
7% ±0.1 mm
Area Measurement Accuracy
10% ±0.1 mm2
Axial Resolution
 20 µm in tissue
Lateral Resolution
25 - 60 µm
Optical Sensitivity
90 db minimum
A-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).)
12-4
St. Jude Medical
Part Number ARTUS100088927
System Specifications
FFR Specifications
FFR Specifications
Table 12-4: FFR Specifications
Parameter
Specification
AO Pressure (Wi-Box to ILUMIEN OPTIS System)
Operating pressure
-180 to +450 mmHg
Accuracy
±1 mmHg plus ±1% of reading (-30 to 50 mmHg)
±3% of reading (50 to 300 mmHg)
AO Pressure (Wi-Box to hemodynamic recording system)
Direct galvanic connection
Max pressure shift
<2 mmHg
Radio Specification
Frequency range
2.4000 - 2.4835 GHz
Type
Frequency hopping spread spectrum (FHSS)
Range
0-4m
Delay time
<20 ms
ILUMIEN OPTIS System
Instructions for Use
12-5
System Specifications
Electromagnetic Emissions
Electromagnetic Emissions
Table 12-5: Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
The ILUMIEN OPTIS System is intended for use in the electromagnetic environment
specified below. The customer or user of the ILUMIEN OPTIS System should assure
that it is used in such an environment.
Emissions Test
12-6
Compliance Electromagnetic Environment - Guidance
RF emissions
CISPR 11
Group 1
The ILUMIEN OPTIS System uses RF energy only
for its internal function. Therefore, its RF emissions are very low and not likely to cause any
interference with nearby electronic equipment.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
The ILUMIEN OPTIS System is suitable for use in
all establishments, including domestic establishments and those directly connected to the public
low-voltage power supply network that supplies
buildings used for domestic proposes.
St. Jude Medical
Part Number ARTUS100088927
System Specifications
Electromagnetic Immunity
Electromagnetic Immunity
Table 12-6: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The ILUMIEN OPTIS System is intended for use in the electromagnetic environment
specified below. The customer or user of the ILUMIEN OPTIS System should assure
that it is used in such an environment.
Immunity Test
IEC 60601 Test
Level
Compliance Level
Electrostatic discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
Electrical fast transient/burst
IEC 61000-4-4
± 2 kV for power sup- ± 2 kV for power sup- Mains power quality
ply lines
ply lines
should be that of a typical commercial or hos± 1 kV for input/out- ± 1 kV for input/outpital environment.
put lines
put lines
Surge
IEC 61000-4-5
± 1 kV lines(s) to
line(s)
± 1 kV lines(s) to
line(s)
± 2 kV lines(s) to
earth
± 2 kV lines(s) to
earth
< 5 % UT
(>95% dip in UT) for
0.5 cycle
< 5% UT
(>95% dip in UT) for
0.5 cycle
40% UT
(>60% dip in UT)
for 5 cycles
40% UT
(>60% dip in UT) for
5 cycles
70% UT
(30% dip in UT) for
25 cycles
<70% UT
(>30% dip in UT) for
25 cycles
<5% UT
(>95% dip in UT) for
5 seconds
<5% UT
(>95% dip in UT) for
5 seconds
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
± 6 kV contact
± 8 kV air
Electromagnetic
Environment Guidance
Floors should be wood,
concrete or ceramic tile.
If floors are covered
with synthetic material,
the relative humidity
should be at least 30%.
Mains power quality
should be that of a typical commercial or hospital environment.
Mains power quality
should be that of a typical commercial or hospital environment. If
the user of the ILUMIEN
OPTIS System requires
continued operation
during power mains
interruptions, it is recommended that the
ILUMIEN OPTIS be powered from an uninterruptible power supply
or battery.
NOTE: UT is the AC mains voltage prior to application of the test level.
ILUMIEN OPTIS System
Instructions for Use
12-7
System Specifications
Electromagnetic Immunity
Table 12-6: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The ILUMIEN OPTIS System is intended for use in the electromagnetic environment
specified below. The customer or user of the ILUMIEN OPTIS System should assure
that it is used in such an environment. (continued)
Immunity Test
IEC 60601 Test
Level
Power frequency
3 A/m
(50/60 Hz) magnetic
field
IEC 61000-4-8
12-8
Compliance Level
3 A/m
Electromagnetic
Environment Guidance
Power frequency magnetic fields should be at
levels characteristic of
a typical commercial or
hospital environment.
St. Jude Medical
Part Number ARTUS100088927
System Specifications
Electromagnetic Immunity
Table 12-7: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The ILUMIEN OPTIS System is intended for use in the electromagnetic environment
specified in this section. The customer or user of the ILUMIEN OPTIS System should
assure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment Guidance
Portable and mobile RF communications equipment should be used no
closer to any part of the ILUMIEN OPTIS
System, including cables, than the recommended separation distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
d = 1.2 P
d = 1.2 P 80 MHz to 800 MHz
d = 2.3 P 800 MHz to 2.5 GHz
3 V/m
Where P is the maximum output power
rating of the transmitter in Watts (W)
according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic 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:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects, and people.
ILUMIEN OPTIS System
Instructions for Use
12-9
System Specifications
Electromagnetic Immunity
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the ILUMIEN
OPTIS System is used exceeds the applicable RF compliance level above, the ILUMIEN
OPTIS System should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the
ILUMIEN OPTIS System.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
3 V/m.
12-10
St. Jude Medical
Part Number ARTUS100088927
System Specifications
Recommended Separation Distances
Recommended Separation Distances
Table 12-8: Recommended separation distances between portable and mobile RF communications equipment and the ILUMIEN OPTIS System
The ILUMIEN OPTIS System is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user of the
ILUMIEN OPTIS System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (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 m
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d = 1.2 P
d = 1.2 P
d = 2.3 P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1.2
1.2
2.3
10
3.8
3.8
7.3
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects, and people.
ILUMIEN OPTIS System
Instructions for Use
12-11
System Specifications
FCC Statement
FCC Statement
This equipment has been tested and found to comply with the limits for a Class A digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential
area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.
Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including
interference that may cause undesired operation.
Changes or modifications not expressly approved by St. Jude Medical could void the
user’s authority to operate the equipment.
Essential Performance Defined by Operating Mode
During testing, the OCT Imaging System (MN: C8/ILUMIEN OPTIS) was operating as
follows: SSOCT Data Viewer is displaying white noise. The CardioUI Development software is running. The probe is active and displaying an image. Image on screen is stable
and without error. Also host PC is pinging the EUT.
12-12
St. Jude Medical
Part Number ARTUS100088927
Index
Symbols
%AS, 7-2, 7-10
%DS, 7-2, 7-12
Calculation
%AS, 7-10
%DS, 7-12
Callout
adding, 7-9
position, 7-9
Callouts
adding, 7-8
Case
importing, 8-22
Catheter
connection to DOC, 4-4, 5-6
disconnecting from DOC, 5-17
insertion, 5-11
positioning, 5-11
preparation, 5-5
purge, 5-7
removal, 5-17
stop movement, 5-18
Caution, meaning and format, Front-iv
Chart Holder, 1-5
Cleaning, 9-2
Complications, 1-15
Complications from Use, 1-15
Connection
network, 1-7
power, 2-2
USB, 1-7
video, 1-7
Connector Panel
description, 1-6
location, 1-4
Numerics
3D Display, 7-22
Acquisition mode, 10-23
Adding Points, 7-17
Air Filter, 1-5
Air Filter Maintenance, 9-10
Annotation
adding text, 7-8
text, 7-9
Area Measurements
automatic, 7-6
Auto Cycle Drawing Color, 10-17
Automatic MLA and %DS option, 7-19
Black Level, 9-15
Bookmark
clear all bookmarks, 6-9
creating, 6-9
next bookmark, 6-9
previous bookmark, 6-9
ILUMIEN OPTIS System
Instructions for Use
Index-1
Index
Contact Information
company, Front-ii
service, 9-2
Contraindications for Use, 1-12
Control Point Size, 10-17
Conventions Used in Manual, Front-iv
Creating a New Patient, 3-5
Cross-section View
zoom, 7-15
FFR Procedure
catheter connection, 4-4
materials and equipment, 4-1
File Size, 8-6
Files
deleting, 8-25
Flush Medium
warning, 1-13
Database
create a new patient, 3-5
import, 8-20, 8-22
Setup dialog box, 10-6
statistics, 8-28, 10-7
Database Tab, 10-6
Delete
files, 8-25
measurements, 7-18
points, 7-17
Depth Calibration Marks, 5-14
Diagnostics Tab, 10-23
DICOM
viewer, 8-16
DICOM Tab, 10-9
DOC
catheter connection, 4-4, 5-6
cleaning optical connection, 9-5
description, 1-9
preparation, 5-4
replacing optical adapter, 9-8
Drive-motor and Optical Controller, 1-9
Electrical Connections, 11-6
Electrical Hazards, 11-5
Enable button on DOC, 1-9
Enable Softkey, 5-15
External Drive, 8-9, 8-10, 8-12
Index-2
Green’s Theorem, 7-6
Hazards
electrical, 11-5
explosion, 11-7
light emission, 11-3
repetitive strain injury, 11-3
Home menu, 3-2
Image Compression
caution, 7-1, 8-7
Image Format
raw, 8-4
standard, 8-5
Imaging
limitations, 11-7
tissue, 11-7
vessel, 11-7
Imaging Specifications
optical parameters, 12-4
pullback parameters, 12-4
scan parameters, 12-4
Import OCT Files, 8-20
Indications for Use, 1-11
Infection Control, 9-13
Instructions for Use
other manuals, Front-iv
Intended Use, 1-11
St. Jude Medical
Part Number ARTUS100088927
Index
Length Measurement, 7-5
Line Width, 10-17
Live Mode, 10-23
Live View, 5-3
Live View Button on DOC, 1-9
L-Mode
caution, 7-3
cut-plane, 5-14
limitations, 6-5
measurements and annotations, 7-3
Lock LED on DOC, 1-9
Log Files, 9-11, 10-21
Lumen Profile, 7-19
OCT Database, see Database
OCT Procedure
catheter connection, 5-6
catheter insertion, 5-11
catheter positioning, 5-11
catheter preparation, 5-5
completing procedure, 5-17
DOC preparation, 5-4
materials and equipment, 5-1
recording, 5-14
Operator Safety
light emission hazards, 11-3
moving the system, 11-4
repetitive strain injury, 11-3
Optical Coherence Tomography, 1-1
Optical Parameters, 12-4
Optimal Tissue Imaging, 11-7
Optimal Vessel Imaging, 11-7
Options Tab, 10-19
Maintenance, 9-4
Manual
conventions, Front-iv
Measurement Accuracy, 7-3
Measurement and Annotation tools, 7-2
Measurements
adding points, 7-17
caution, 7-1, 8-7
deleting all measurements, 7-18
deleting individual measurements, 7-18
deleting measurements, 7-18
deleting points, 7-17
editing, 7-16
length, 7-5
moving individual points, 7-17
Minimum Lumen Area, 7-20
MLA, 7-20
Monitor Setup, 2-6
Moving Points, 7-17
Moving System, 11-4
Near-infrared Light, 1-1, 11-2
Network Connection, 1-7
Note, meaning and format, Front-iv
ILUMIEN OPTIS System
Instructions for Use
Patient
acquiring image, 5-14
creating a record, 3-5
minimizing exposure, 11-2
safety, 11-2
Patient Entry
creating, 3-5
Patient Record
Open, Create, 3-1
Pen Color, 10-17
Percent Area Stenosis, 7-2, 7-10
Percent Diameter Stenosis, 7-2, 7-12
PIU. See DOC
Playback Calibration
setting, 6-7
Playback Mode, 10-23
playback range, 6-10
Positioning the System, 2-1
Power
off, 2-4
on, 2-3
Index-3
Index
Power In, 12-3
Precautions for Use, 1-14
Pullback
parameters, 12-4
stop, 5-18
trigger, 10-2
Pullback motion LEDs on DOC, 1-9
Purge Catheter, 5-7
Range
playback, 6-10
Raw Format
description, 8-4
Recording
status, 5-14
Recording calibration marks, 5-14
Remote DICOM Store, 8-11
Reviewing
saved images, 6-1
Safety
functions, 11-9
operator, 11-3
patient, 11-2
Segmented Lumen, 7-24
Select Measurement
percent area stenosis, 7-10
percent diameter stenosis, 7-12
Select Patient menu, 3-2
Service Tab, 10-21
Setup Dialog Box
Database tab, 10-6
Diagnostics tab, 10-23
DICOM tab, 10-9
Options tab, 10-19
Service tab, 10-21
Shutdown
procedure, 2-4
Index-4
Specifications
electrical and physical, 12-3
electromagnetic, 12-6, 12-7, 12-9
imaging, 12-4
pressure and radio, 12-5
safety and regulatory, 12-1
Standard File Format, 8-6
Standard Format
description, 8-5
Standby View, 5-3
Stop Button on DOC, 1-9
System
components, 1-2
connector panel, 1-6
features, 1-1
imaging limitations, 11-7
moving, 11-4
power on, 2-3
setup, 2-1
shut down, 2-4
System Display
during image acquisition, 5-14
System Specifications
classifications, 12-2
leakage & auxiliary current, 12-2
mechanical specifications, 12-3
operating conditions, 12-3
power input, 12-3
software safety features, 12-2
transport and storage conditions, 12-3
Text
adding, 7-8
display options, 7-9
entry, 7-9
position, 7-9
Tissue Imaging, 11-7
Tools
annotation, 7-2
measurement, 7-2
Transfer Messages, 8-26, 8-28
Trigger Type, 10-2
St. Jude Medical
Part Number ARTUS100088927
Index
Troubleshooting
connections, 9-14
DOC, 9-15
general, 9-14
imaging, 9-15
PressureWire
power failure, 4-14
Unload button on DOC, 1-9
USB
connection, 1-7
media, 8-2
Vessel Imaging, 11-7
Video Connection, 1-7
Warning, 1-13
Warning, meaning and format, Front-iv
Weight, 12-3
White Level, 9-15
Wi-Box
cathlab installation, 1-10
Zoom
DICOM Viewer, 8-17
measurements, 7-3
region, 7-15
ILUMIEN OPTIS System
Instructions for Use
Index-5
Index
Index-6
St. Jude Medical
Part Number ARTUS100088927


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