ILUMIEN OPTIS System Instructions for Use Manual March 2013

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: [email protected] Part Number ARTUS100088927 ENGLISH Printed in the U.S.A. 3 / 2013

CAUTION: Federal law restricts this device to sale by or on the order of a Physician licensed by law of the state in which he practices to use or order the use of the device.

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

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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: <Enter>, <Ctrl>, <Tab>.

•

Warnings, Cautions, and Notes are set apart from other text and appear as shown below.

WARNING: Warnings alert the user to the possibility of injury, death, or other serious adverse reactions associated with product use or misuse. CAUTION: Cautions alert the user to the possibility of a problem with the product associated with its use or misuse. Problems can include product malfunctions, product failure, and/or damage to the product or damage to other property, or loss of data. NOTE:

Notes provide additional information.

Other Instructions for Use Details of the imaging catheter are covered in the Dragonfly Imaging Catheter Instructions for Use 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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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System Overview

1

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

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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

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