Page 1 OPTIS™ Integrated System Instructions for Use...
Page 2 ©2014 St. Jude Medical, Inc. and its related companies. All rights reserved. Reproduction, adaptation, or translation without prior permission is prohibited, except as allowed under copyright laws. OPTIS Integrated systems are subject to US Patents 8,412,312, 8,325,419, 6,565,514; GB, FR 0883793, DE 69738291. ILUMIEN, OPTIS, ST. JUDE MEDICAL, LIGHTLAB IMAGING, GOLDEN IMAGE and the color gold are registered or unregistered trademarks of St.
Page 3 Chapter 2 “System Setup” Chapter 11 “Safety Information” for electrical safety information. Explosion Hazard Do not operate the OPTIS I System in the presence of flammable anesthetics. Doing so NTEGRATED could lead to an explosion. Visible and Invisible Laser Radiation Do not stare into the beam or view the beam directly with optical instruments.
Page 4 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 or the Select button on the Table Side Controller.
Page 5: Table Of Contents
Optis Integrated System Features ........1-1 OPTIS Integrated System Components ........1-2 OPTIS Integrated System Accessories.
Page 6 Setting up the OPTIS Integrated System ....... . . 4-2...
Page 7 Setting up the OPTIS Integrated System ....... . . 5-5...
Page 8 Contents Adjust Playback Settings ..........6-9 Bookmark Controls .
Page 9 Contents Deleting Points from a Multiple Point Area......7-18 Deleting Individual Measurements or Text Callouts ....7-19 Deleting All Measurements and Text Callouts .
Page 10 Contents Cleaning & Maintenance Contacting St. Jude Medical Service ........9-2 Cleaning .
Page 11 Electromagnetic Interference......... 11-8 Safety Functions Built Into the Ilumien Optis System ..... 11-9 System Specifications System - Safety &...
Page 12 Contents viii...
Page 13 Optis Integrated System Cabinet and Control Room Components ..1-4 Optis Integrated System Mobile Workstation ......1-5 Wi-Box in cathlab configuration .
Page 14 Figures 5-13 Safe Unload Guidance, Screen 3 ........5-22 Playback Calibration (DragonFly Duo shown, in progress) .
Page 15 Figures System Startup Window......... 9-13 10-1 Setup - Acquisition Menu.
Page 16 Figures...
Page 17 Tables Front-1 Instructions for Use Conventions ......Front-iv Symbols Description ......... . . 1-8 DOC Controls.
Page 18 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions . . 12-6 12-6 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity . . 12-7 12-7 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity . . 12-9 12-8 Recommended separation distances between portable and mobile RF communica- tions equipment and the Ilumien Optis System12-11...
Page 19: System Overview
NTEGRATED intracoronary pressure transducer and a proximal aortic pressure transducer. The OPTIS Integrated System is built into the catheter lab so that OCT and FFR are immediately available without the need to find, connect, position, and power-on a mobile console. The system allows either the sterile operator or non sterile operator to control...
Page 20: Optis Integrated System Components
System Overview OPTIS Integrated System Components OPTIS I System Components NTEGRATED The OPTIS I System includes the following components, integrated into a NTEGRATED catheter lab: • A system Cabinet which includes an isolation transformer, a laser imaging engine, and a computer.
Page 21: Optis Integrated System Accessories
System Overview OPTIS Integrated System Components OPTIS I System Accessories NTEGRATED • PressureWire • Wi-Box • C7 Dragonfly™ imaging catheter, Dragonfly™ Duo imaging catheter, or Dragon- fly™ OPTIS™ imaging catheter. • Sterile DOC Cover • 3 ml Syringe NOTE: See your sales representative for order numbers of accessories in your market.
Page 22: Optis Integrated System Cabinet And Control Room Components
System Overview OPTIS Integrated System Components Integrated System Cabinet and Control Room Components PTIS ON/OFF Power Switch/ CD/DVD Tray Indicator CD Eject Button Control Room Monitor Keyboard Mouse Figure 1-1: O Integrated System Cabinet and Control Room Components PTIS St. Jude Medical...
Page 23: Optis Integrated System - Mobile Workstation
System Overview OPTIS Integrated System Components System - Mobile Workstation PTIS NTEGRATED Monitor ON/OFF Keyboard Mouse Locking Casters (4) Figure 1-1: O Integrated System Mobile Workstation PTIS System LUMIEN PTIS Instructions for Use...
Page 24: Optis Integrated System Table Side Controller
System Overview OPTIS Integrated System Components OPTIS Integrated System Table Side Controller Select Button Rail Clamp Navigation Controller Features Zoom Auto Lumen Measurement Profile Wireless Distal Marker Proximal Marker Connectivity Indicator Table Side Controller Table Side Controller: The TSC may be used to position the mouse cursor by moving the Navigation Controller to left, right, up, or down.
Page 25: Optis Integrated System Doc Holster
System Overview OPTIS Integrated System Components OPTIS Integrated System DOC Holster Rail Clamp Dust Cover DOC Holster Cable Connections System LUMIEN PTIS Instructions for Use...
Page 26: Optis Integrated Symbols
System Overview OPTIS Integrated System Components OPTIS I Symbols NTEGRATED Before using the system, read these Instructions for Use carefully, including the identifi- cation of symbols used on the equipment. Table 1-1: Symbols Description Equipotential Grounding Post - For a secondary ground connection between equipment.
Page 27 Atmospheric Range (Shipping label) 1060hPa 500hPa Humidity Range (Shipping label) WARNING: All connections to the OPTIS I System must be made NTEGRATED through the System Connector Panel. Making connections directly to internal components of the system may bypass isolation features and compromise patient safety.
Page 28: The Drive-Motor And Optical Controller (Doc)
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 5-8 for Dragonfly Imaging Catheter connection details.
Page 29: The Wi-Box
Figure 1-2. Figure 1-2: 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 OPTIS Integrated System” on page 4-3 for more infor- mation. System LUMIEN...
Page 30: Indications For Use And Intended Use
CAUTION: The OPTIS I System is intended for use by appropriate NTEGRATED medical personnel who have received OPTIS I training. NTEGRATED St. Jude Medical and its employees cannot give instructions in the interpretation or diagnosis of recordings and makes no attempt to do...
Page 31: Contraindications
System Overview Contraindications Contraindications Use of the St. Jude Medical OPTIS I System is contraindicated where intro- NTEGRATED duction of any catheter would constitute a threat to patient safety. Contraindications (listed alphabetically) include: • Bacteremia or sepsis • Major coagulation system abnormalities •...
Page 32: Warnings (Oct)
System Overview Warnings (OCT) Warnings (OCT) • Appropriate anticoagulant and vasodilator therapy must be used during the proce- dure as needed. • Observe all advancement and movement of the Dragonfly Imaging Catheter under fluoroscopy. Always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage.
Page 33: Precautions (Oct)
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 OPTIS I System and the NTEGRATED Dragonfly Imaging Catheter.
Page 34: Complications (Oct)
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 conse- quence of intravascular imaging and may necessitate additional medical treatment includ- ing surgical intervention.
Page 35: Warnings And Precautions (Ffr)
Connection of equipment that does not follow relevant IEC standards (e.g. IEC 60601 series for medical electrical equipment) may lead to patient injury or death. CAUTION: No connections to other systems or components are to be made to the OPTIS I NTEGRATED System except through the Connector Panel.
Page 36: Aortic Reference Pressure
System Overview Warnings and Precautions (FFR) Aortic Reference Pressure CAUTION: Check that the monitor cables and AO adapter delivered with the OPTIS I System NTEGRATED interface are compatible with the cathlab system to be used. The Aortic Pressure Transducer (AO) should be in accordance with ANSI/AAMI BP22-1994.
Page 37: System Setup
System Setup Positioning the System WARNING: Failure to position the system components as described may lead to a system tipping hazard or a pinching hazard, causing possible patient or operator injury and damage to the system. • Confirm that the O Integrated System Cabinet is on a level surface inside the PTIS Control Room or X-Ray Room.
Page 38: Connecting Your System
System Setup Connecting Your System Connecting Your System System Connections To connect the Mobile Workstation to power, plug the power cord into a grounded elec- trical outlet. There is no Main Power Switch on the Mobile Workstation. The System Cabinet and Monitors are normally always connected to power. Powering On and Shutting Down Your System Make sure the power cords are connected to the System Cabinet, optional Mobile Work- station (if used), and control room monitor and they are plugged into grounded electrical...
Page 39: Power On System Cabinet
System Setup Powering On and Shutting Down Your System Power On System Cabinet To power on your System Cabinet: Confirm that all monitors are powered by observing that the appropriate power indicators are lit. See “Monitor Setup” on page 2-6 for details.
Page 40: Shut Down
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 shut- down is complete, the screens turn black, and the monitor LEDs turn amber. Disconnecting from AC power before the shutdown is com- plete may damage the system.
Page 41: Ffr Settings
System Setup FFR Settings FFR Settings NOTE: To access the full FFR Settings menu, you must be in the process of mak- ing an FFR recording, and have selected a room for the FFR procedure. Click the Settings button at the top of the screen. The FFR Settings menu opens.
Page 42: Monitor Setup
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 sur- rounding lighting.
Page 43: Opening A Patient Record
OPTIS I System complies with applicable NTEGRATED 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 OPTIS I System. NTEGRATED System LUMIEN...
Page 44: Select Patient Menu (Home Menu)
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.
Page 45 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.
Page 46: Patient Summary Menu
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.
Page 47 Opening a Patient Record Patient Summary Menu Table 3-2: Patient Summary Menu functions Case List (dates of recordings) for this patient. The list is sorted by date, with the most recent recordings at the top. System LUMIEN PTIS Instructions for Use...
Page 48: Entering New Patient Information
Opening a Patient Record Entering New Patient Information Entering New Patient Information You can enter a new patient from the Select Patient menu. In the Select Patient menu, select the Add Patient button. Click Next. The Add Patient Wizard displays. NOTE: You can also import patient information from a DICOM storage server or worklist.
Page 49 Opening a Patient Record Entering New Patient Information Enter the patient information as needed. NOTE: You must enter Patient ID, First name, and Last name before you can save the patient information. Click New OCT Recording to save and begin a new OCT recording for this patient, click New FFR Recording to save and begin a new FFR recording for this patient, or Cancel to close the menu without saving and return to the Select Patient menu.
Page 50: Editing Patient Information
Opening a Patient Record Editing Patient Information Editing Patient Information The patient information can be edited from the Patient Summary menu. In the Select Patient menu, click on the patient. The Patient Summary menu for that patient opens (see Figure 3-3).
Page 51: Editing Case Information
The Patient Summary menu for that patient opens (see Figure 3-3). Click on a case to select it. NOTE: In the OPTIS I System, all recordings and still images NTEGRATED from the same date use the same physician and accession number. Click the Edit Case button.
Page 52: Importing A Patient Database
Opening a Patient Record Importing a Patient Database Importing a Patient Database Previous C7 XR, I , and OPTIS I OCT and FFR recordings can be LUMIEN NTEGRATED 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...
Page 53: Opening A Saved Recording Or Still Image
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.
Page 54 Opening a Patient Record Opening a Saved Recording or Still Image Figure 3-8: OCT Review Screen • To navigate an OCT recording, see “Playback Controls” on page 6-6; to nav- igate an FFR recording, see “Reviewing an FFR Recording” on page 4-13.
Page 55: Performing An Ffr Procedure
Required Material and Equipment • OPTIS I System NTEGRATED • PressureWire • Wi-Box, installed in each room where the OPTIS I System is to be used NTEGRATED to measure FFR • Heparinized, physiologic saline solution, for hydrophilic catheter preparation System LUMIEN...
Page 56: Setting Up The Optis Integrated System
Performing an FFR Procedure Setting up the OPTIS Integrated System Setting up the OPTIS I System NTEGRATED Position the system for use. See “Positioning the System” on page 2-1. Turn on the system. See “Power On System Cabinet” on page 2-3.
Page 57: Setting Up The Wi-Box With The Optis Integrated System
Setting up the Wi-Box with the OPTIS I System NTEGRATED The Wi-Box should be connected to your facility’s Hemodynamic Recording System at installation. Complete the following steps to connect the OPTIS I System to NTEGRATED a Wi-Box for the first time .
Page 58: Setting Up The Pressurewire
Room Manager dialog box, which enables the Remove button. Then, click the Remove button to delete the current selection. Then, follow the steps listed in “Setting up the Wi-Box with the OPTIS Integrated System” on page 4-3 above. 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.
Page 59: Preparing To Record Ffr
Performing an FFR Procedure Preparing to Record FFR Preparing to Record FFR WARNING: The heart rate and mean pressure values shown on the OPTIS I System are for reference only and are not intended to be used GRATED as the primary display.
Page 60 Performing an FFR Procedure Preparing to Record FFR 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 4-3: Set AO transducer height and open AO transducer guidance message Position the AO transducer so that it is level with the patient’s heart.
Page 61 Performing an FFR Procedure Preparing to Record FFR In the Pa measurement box, click the Zero button, or on the Table Side Controller press the Proximal Marker button. Figure 4-4: Flush PressureWire guidance message Close the AO transducer. Prepare the PressureWire in accordance with the PressureWire Instructions for Use and the on screen prompts.
Page 62 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 4-5: Turn on PressureWire guidance message CAUTION: Do not turn on more than one PressureWire while the system is Searching/Connecting.
Page 63 Performing an FFR Procedure Preparing to Record FFR The pressure from the AO transducer and PressureWire must now be equalized. Figure 4-6: 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 continu- ing.
Page 64 Performing an FFR Procedure Preparing to Record FFR Check the pressures displayed in the Pa and Pd measurement boxes (See Figure 4-6 on page 4-9). If the pressures are not equal, click the Equalize button (or on the Table Side Controller press the Proximal Marker button) to equalize the pressure reading between the AO transducer and the PressureWire.
Page 65: Recording Ffr
Performing an FFR Procedure Recording FFR Recording FFR Confirm that the FFR settings are correct for the current procedure. See “FFR Set- tings” on page 2-5 for more information. With the PressureWire in position and equalized, advance it across the area to be examined.
Page 66 Performing an FFR Procedure Recording FFR on the recording for later review. A mark appears as a vertical white line on the recording. Figure 4-8: Recording Record pressure until steady state maximum hyperemic condition is reached, until the hyperemic effect begins to decrease, or until the physician decides to end the recording.
Page 67: Reviewing An Ffr Recording
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, for example artifacts in AO (Pa) caused by flushing of guiding catheter or valve opening/closing.
Page 68 Performing an FFR Procedure Reviewing an FFR Recording Patient name and ID. “Entering New Patient Information” on page 3-6 for more information. Recording date and time. Print file to USB button: Available when a USB drive is connected. Click to print the FFR recording file to a USB drive.
Page 69: Pressurewire Troubleshooting
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 mea- surement box. If there is a problem with your PressureWire, refer to the PressureWire Instructions for Use for details.
Page 70 Performing an FFR Procedure PressureWire Troubleshooting St. Jude Medical 4-16 Part Number ARTUS100109403...
Page 71: Performing An Oct Procedure
• OPTIS I System NTEGRATED • C7 Dragonfly Imaging Catheter, Dragonfly Duo Imaging Catheter, or Dragonfly OPTIS 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) •...
Page 72: Oct Imaging Overview
Performing an OCT Procedure Overview OCT Imaging Overview Position - Locate the Dragonfly imaging catheter relative to the target lesion/stent. Purge - Clear blood from the catheter lumen, if present, using the attached 3 mL syringe. Puff - Inject a small amount (~ 4 mL) of contrast through the guide catheter to eval- uate clearance.
Page 73: Oct Operating Modes
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. •...
Page 74: Oct Trigger Types
Performing an OCT Procedure OCT Trigger Types OCT Trigger Types Automatic - The default setting in which the system triggers a pullback automatically when a brief sequence of clear image frames are detected as a result of contrast injection. If the flush injection is not detected within 15 seconds after being enabled, the system returns to Live View.
Page 75: Angio-Coregistration
OCT frames correlate with the corresponding angiography position. This functional- ity allows the user to more easily determine their position in the OCT relative to the lesion and assists in stent location and placement. Setting up the OPTIS I System NTEGRATED Position the system for use.
Page 76: Setting Up The Doc
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 From...
Page 77: Setting Up The Dragonfly Imaging Catheter
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. Inspect the packaging of the catheter for damage. Ensure that the catheter has not passed its expiration date.
Page 78: Preparing To Acquire Oct Recordings
Performing an OCT Procedure Preparing to Acquire OCT Recordings Preparing to Acquire OCT Recordings New OCT recordings are started from the Patient Summary menu. If necessary, enter the patient’s information. See “Entering New Patient Informa- tion” on page 3-6. NOTE: Patient information should be entered into the system and selected for use before beginning a recording.
Page 79 Performing an OCT Procedure Preparing to Acquire OCT Recordings The screen displays the guidance message “Purge catheter with contrast” (Figure 5-2). Figure 5-2: Purge Catheter guidance message NOTE: To prevent this guidance message from appearing, check the box next to the message “Do not show this screen again.”...
Page 80 Performing an OCT Procedure Preparing to Acquire OCT Recordings 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 Insert the hub of the catheter into the port of the DOC, and twist the hub clockwise until secure ( turn).
Page 81 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”...
Page 82: Confirm Recording Settings
NOTE: Only 100% contrast media is approved for human OCT Imaging. NOTE: Click the Menu button at the bottom of the screen to open the OPTIS I System Setup dialog box. See Chapter 10 NTEGRATED “User Interface Reference” for more information.
Page 83: Dragonfly Imaging Catheter Insertion And Positioning
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 oper- ation.
Page 84 Metallic Coating Layer Incorrect Incorrect Correct Figure 5-8: Incorrect and Correct Calibration (Dragonfly OPTIS shown in fingertips) NOTE: Ensure accurate calibration prior to a recording. Incorrect calibration may cause early pullback initiation and incorrect measurements. St. Jude Medical 5-14...
Page 85 Performing an OCT Procedure Dragonfly Imaging Catheter Insertion and Positioning 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.
Page 86: Acquiring Patient Images
Performing an OCT Procedure Acquiring Patient Images Acquiring Patient Images The System Display during image acquisition is shown in Figure 5-9. Patient Information Image Window Recording Calibration Marks Depth Calibration Marks L-Mode Display Recording (in progress) Figure 5-9: System Display - Acquisition Table 5-1: System Display Description - Acquisition Patient Information Displays the Patient name and ID.
Page 87 Performing an OCT Procedure Acquiring Patient Images NOTE: If you are performing a Stationary recording, the Enable Pullback and Start Pullback buttons are replaced with a Start Recording button. Do not click the Start Recording button until you have notified the person injecting the contrast media that the system is ready.
Page 88: Removing The Dragonfly Imaging Catheter
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 Recordings”) or transferred to removable media for review on a St.
Page 89: Troubleshooting Oct Acquisition
Performing an OCT Procedure Troubleshooting OCT Acquisition Troubleshooting OCT Acquisition Immediately Stopping DOC Operation 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.
Page 90: Catheter Failure
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 5-10: Catheter Failure message CAUTION: Do not click the OK button until after you have removed the...
Page 91 Performing an OCT Procedure Troubleshooting OCT Acquisition After acknowledging the alert, the Safe Unload Guidance displays as shown below. Figure 5-11: Safe Unload Guidance, Screen 1 Turn the catheter hub 1/4-turn counter-clockwise as directed. While the DOC is unloading the catheter, the Guidance displays the screen below: Figure 5-12: Safe Unload Guidance, Screen 2 System LUMIEN...
Page 92 Performing an OCT Procedure Troubleshooting OCT Acquisition When the DOC is finished unloading the catheter, the Guidance displays the screen below: Figure 5-13: Safe Unload Guidance, Screen 3 Remove the existing Dragonfly Imaging Catheter in the normal manner. Click Next. Load a new Dragonfly Imaging Catheter in the normal manner.
Page 93: Reviewing Oct Recordings
Reviewing OCT Recordings NOTE: Making measurements, calculations, and text annotations is covered in Chapter 7 “Measurements and Annotations”. Exporting images is covered Chapter 8 “Exporting, Importing, and Managing Files”. System LUMIEN PTIS Instructions for Use...
Page 94: Image Window
Reviewing OCT Recordings Image Window Image Window When reviewing recordings, the Image Window shows a cross-section of the pullback or still frame (Table 6-1). Table 6-1: OCT Display Overview Patient name and ID. “Entering New Patient Information” on page 3-6 for more information.
Page 95 Patient Summary menu. See “Patient Summary Menu” on page 3-4 for more information. NOTE: While the OPTIS I System is connected to a Dragonfly imaging cathe- NTEGRATED ter, the button New Recording appears here. Click the New Recording button to close this review and begin a new OCT recording.
Page 96: L-Mode View
Reviewing OCT Recordings L-Mode View L-Mode View NOTE: If reviewing a Stationary recording, the L-Mode display is renamed Time- line. 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.
Page 97: Limitations Of L-Mode Data
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. •...
Page 98: Playback Controls
Reviewing OCT Recordings Playback Controls Playback Controls Table 6-3: Playback Controls Menu: Displays the context-sensitive menu. Click to access the Setup and playback Calibration controls. 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.
Page 99: Calibration Adjustment
Reviewing OCT Recordings Calibration Adjustment Calibration Adjustment Use the Adjust Calibration tool to adjust the calibration of the recording. Use the Playback Controls at the bottom of the screen to pause the playback. Hover or click on the Menu button at the bottom of the screen and select the Cali- bration option.
Page 100 Reviewing OCT Recordings Calibration Adjustment NOTE: 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.
Page 101: Adjust Playback Settings
Reviewing OCT Recordings Adjust Playback Settings Adjust Playback Settings Click the Settings button at the top of the screen. A context-sensitive menu opens. Click and drag the Playback Speed slider bar to set the playback speed. Click and drag the Rotation slider bar to rotate the image shown in the cross-sec- tion view.
Page 102: Bookmark Controls
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.
Page 103: Setting Playback Range
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.
Page 104: Exporting A Recording Or Still Frame
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 informa- tion 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.
Page 105: Printing Still Images
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.
Page 106: Reviewing With Angio-Coregistration
Reviewing OCT Recordings Reviewing with Angio-Coregistration Reviewing with Angio-Coregistration Only pullback images that contain angio-coregistration data can be used for this type of review. Identify the presence of angio-coregistration data by locating a black and white angiographic thumbnail image in the upper-left corner of the pullback on the Patient Summary screen.
Page 107 Reviewing OCT Recordings Reviewing with Angio-Coregistration Figure 6-5: View Menu, Angio Co-Registration Button Pause the recording and click the Angio Co-Registration button under the View menu to initiate the Angio Co-Registration process. The angiography displays in the left window. NOTE: To view the angiography along with the MLA data, click the MLA box in the View menu.
Page 108 Reviewing OCT Recordings Reviewing with Angio-Coregistration Figure 6-6: Angio Co-Registration: Register Click on the Register button to initiate the co-registration. Step 1 of the Angio Co-Registration Guidance displays. Figure 6-7: Angio Co-Registration Guidance, Step 1 St. Jude Medical 6-16 Part Number ARTUS100109403...
Page 109 Reviewing OCT Recordings Reviewing with Angio-Coregistration Set the first (distal) control point by placing the cursor in the vessel of interest, on the guidewire (or just proximal of the guidewire), and clicking. A white control point and Step 2 of the Angio Co-Registration Guidance displays. Figure 6-8: Angio Co-Registration Guidance, Step 2 Moving distal to proximal, set at least one additional control point by placing the cursor in the vessel of interest, distally near the guide catheter tip and clicking.
Page 110 Reviewing OCT Recordings Reviewing with Angio-Coregistration Figure 6-9: Angio Co-Registration Guidance, Step 2 with Trace NOTE: If after placing the proximal point, an incorrect vessel path is traced, click the Undo button, then replace the proximal control point. Fol- low the on-screen guidance. Verify that the trace is in the vessel of interest.
Page 111 Reviewing OCT Recordings Reviewing with Angio-Coregistration Figure 6-10: Angio Co-Registration Guidance, Step 3 Click the Confirm button to accept the path within the vessel of interest. The Please wait for co-registration screen displays while the system correlates the angiography with the OCT frames. When the co-registration is complete, the Coregistration completed successfully screen displays.
Page 112 Reviewing OCT Recordings Reviewing with Angio-Coregistration Figure 6-11: Angio Co-registration completed successfully screen Click the Accept button to use the successful Angio Co-Registration. The main screen displays the co-registered images. Figure 6-12: Main Screen showing Angio Co-Registration St. Jude Medical 6-20 Part Number ARTUS100109403...
Page 113 Reviewing OCT Recordings Reviewing with Angio-Coregistration NOTE: To use the Quick Zoom feature (see “Quick Zoom” on page 7-16) on the Angiography window, simply click on the angiography image. System LUMIEN PTIS Instructions for Use 6-21...
Page 114 Reviewing OCT Recordings Reviewing with Angio-Coregistration St. Jude Medical 6-22 Part Number ARTUS100109403...
Page 115: Measurements And Annotations
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 proce- dure are preserved in the file.
Page 116: Measurement And Annotation Tools
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 can be accessed on screen by hovering over the Tools Panel (wrench symbol). As measurements are added to the image, they are labeled with successive control letters (A, B, C, etc., up to 26 measurements per frame).
Page 117: Verifying Calibration
NOTE: Calibration before making measurements should not be necessary when using the Dragonfly OPTIS catheter. The OPTIS Integrated software in conjunction with the Dragonfly OPTIS catheter uses Continuous Calibra- tion technology to eliminate the need for this step in the workflow.
Page 118: Length Measurements
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 St. Jude Medical Part Number ARTUS100109403...
Page 119: Making A Length (Distance) Measurement
Measurements and Annotations Length Measurements Making a Length (Distance) Measurement Select the still image or paused recording that you want to measure. Click on the Length button (Figure 7-2). The cursor changes to a pen. Click anywhere in the Image Window (cross-section view or L-Mode view) to place the starting point for the length measurement.
Page 120: Area Measurements
Measurements and Annotations Area Measurements Area Measurements You can manually create a closed area trace of the lumen contour in the cross-sec- tion view. The area is calculated using Green’s Theorem, and is displayed in the frame in mm 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”...
Page 121 Measurements and Annotations Area Measurements NOTE: 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.
Page 122: Adding Text Callouts
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 St. Jude Medical Part Number ARTUS100109403...
Page 123 Measurements and Annotations Adding Text Callouts Adding Text Callouts Select the still image or paused recording that you want to annotate with text. Click on the Text... button (Figure 7-1). The cursor changes to a Text marker (“A”). Place the cursor where you want the text to be displayed. The Enter Note menu (see Figure 7-5) appears.
Page 124: The %As Calculation
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.
Page 125 Measurements and Annotations The %AS Calculation The % Area Stenosis calculation is displayed immediately below the previous cal- culations 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 measure- ment, a %AS value will not be displayed.
Page 126: The %Ds Calculation
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...
Page 127 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: If the second measurement is larger than the first measurement you select, a %DS value will not be displayed.
Page 128: Field Of View
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.
Page 129: Zooming In Manually
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. Place the cursor over the image area you want to enlarge. Click and drag the mouse across an area to magnify it.
Page 130: Quick Zoom
Measurements and Annotations Field of View Quick Zoom The Quick Zoom feature provides two pre-set levels of magnification by simply clicking on the image with the left mouse button. Hover over the cross-sectional view so your cursor changes into a magnifying glass icon. Click once to zoom in to the first level;...
Page 131: Editing Measurements And Annotations
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: When a measurement is changed, calculations that depend on that mea- surement are updated automatically.
Page 132: Moving Individual Points
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, indi- cating that it may now be moved.
Page 133: Deleting Individual Measurements Or Text Callouts
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: •...
Page 134: Lumen Profile Display Option
Measurements and Annotations Lumen Profile Display Option Lumen Profile Display Option The system automatically creates a trace of the lumen contour on each frame. NOTE: Lumen Profile is not available with still images or station- ary recordings. L-Mode view must be turned on in order to use the Lumen Profile display option.
Page 135: Lumen Profile Display With Mla Controls Overview
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 “?.??”...
Page 136 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 %DS = 100 * (D ) / D %AS = 100 * (A ) / A of the MLA frame compared to average...
Page 137: 3D Display Option
Measurements and Annotations 3D Display Option 3D Display Option Click the Advanced Display button to create a 3D representation of the recording. Clicking the Advanced Display button toggles-through the options: Off, 3D Tissue, and 3D Lumen. You can also select the desired option by clicking the button next to it. NOTE: You cannot add or change measurements or annotations in the cross-section view or 3D Display while 3D Display is on.
Page 138: 3D Tissue Controls
Measurements and Annotations 3D Display Option 3D Tissue Controls Table 7-4: 3D Tissue Controls Cross-Section View 3D Display (Tissue Option Shown) View Mode : Click to toggle between Window mode (shown above) and Full Screen Mode. Current Frame Indicator (3D View) : Scroll the mouse wheel (or twist the Navagation Con- troller) to change the cut plane as shown in the L-Mode.
Page 139: 3D Display With Lumen
Measurements and Annotations 3D Display Option 3D Display with Lumen NOTE: If the 3D Lumen setting is turned on, the 3D Tissue setting is turned off, and vice-versa. Selecting one deselects the other. The 3D Lumen setting adds a 3D representation of the lumen contours drawn on each frame.
Page 140: Limitations Of 3D Display
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. •...
Page 141: Exporting, Importing, And Managing Files
OPTIS I System complies with applicable NTEGRATED 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 OPTIS I System. NTEGRATED System LUMIEN...
Page 142: Compatible Transfer Media And Usb Devices
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.
Page 143 Exporting, Importing, and Managing Files Compatible Transfer Media and USB Devices the USB port in the patient vicinity may compromise electrical isola- tion and cause patient injury. NOTE: Outside the catheterization lab, IEC 60950-compliant, externally powered USB hard drives may be connected to the USB port. System LUMIEN PTIS...
Page 144: File Formats
Note the following: • Native (raw OCT) files can be reviewed and manipulated only with an I LUMIEN System, an OPTIS I System, or an ORW. They cannot be accessed with NTEGRATED any other systems or software. •...
Page 145: 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 appli- cations outside the system, but cannot be imported into an I System, an OPTIS LUMIEN System, OPTIS M System, or an ORW.
Page 146: Image Format And Size In Standard Formats
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 •...
Page 147: Exporting Files During A Review
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.
Page 148: Exporting Files In Native (Raw) Format
Exporting, Importing, and Managing Files Exporting Files During a Review Exporting Files in Native (Raw) Format Click the Export button. The Export Wizard opens (see Figure 8-2). Figure 8-2: The Export Wizard - Step 1 Click to select Native (Raw), and click Next. If you need to remove patient identifying information from the exported files, add a check to the Anonymize checkbox.
Page 149 Exporting, Importing, and Managing Files Exporting Files During a Review • 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 to set the System File Options for the file(s) that you are exporting: •...
Page 150: Exporting Files In Dicom Format
Exporting, Importing, and Managing Files Exporting Files During a Review When complete, click Done to close the Export Wizard. Exporting Files in DICOM Format Click the Export button. The Export Wizard opens (see Figure 8-2). Click to select DICOM, and click Next. NOTE: If you are reviewing a single frame instead of a recording, skip to Step 5...
Page 151 Exporting, Importing, and Managing Files Exporting Files During a Review 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.
Page 152: Exporting Files In Standard Formats
Exporting, Importing, and Managing Files Exporting Files During a Review Exporting Files in Standard Formats NOTE: 3D reconstructions cannot be exported in Standard formats. Click the Export button. The Export Wizard opens (see Figure 8-2). Click to select Standard, and click Next. NOTE: If you are reviewing a single frame instead of a recording, skip to Step...
Page 153 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.
Page 154: Exporting Files From The Patient Summary Menu
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. In the Patient Summary menu, add a check to the checkbox of each file that you want to export.
Page 155 Exporting, Importing, and Managing Files Exporting Files from the Patient Summary Menu To filter the list, click the All, Unarchived, or New since last archive button. If necessary, add a check to the checkbox of any other recording to be exported. •...
Page 156: Using Exported Standard Format Recordings
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. How- ever, the Compressed AVI format and the Multi-page TIFF formats require that you have special players installed on your computer to review the files.
Page 157 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 con- tained in the DICOMDIR file on the CD/DVD.
Page 158 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.
Page 159 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...
Page 160: Importing Files From A Cd/Dvd Or Usb
Exporting, Importing, and Managing Files Importing Files from a CD/DVD or USB Importing Files from a CD/DVD or USB Connect an external database to the I System: LUMIEN PTIS • Insert a CD/DVD containing a database into the system. • Connect an external hard drive to the system.
Page 161 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 &...
Page 162: Deleting Files
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). •...
Page 163: Deleting Files From The Database Menu
Exporting, Importing, and Managing Files Deleting Files Deleting Files from the Database Menu Click the Menu button and select Setup. The Setup dialog box opens. Click the Database button to open the Database menu (see Figure on page 10-7). Add a check to the checkbox of any recording to be deleted. •...
Page 164: Transfer And Import Messages
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.
Page 165 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 con- Insert a new writable disc is not blank. tains files and cannot be CD/DVD into the drive and appended.
Page 166: Duplicate File Name Messages
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.
Page 167: Importing Patient Information From A Dicom Worklist Or Storage Server
Exporting, Importing, and Managing Files Database Statistics Importing Patient Information From a DICOM Worklist or Storage Server From DICOM Worklist To import patient information From a DICOM Worklist, complete the following steps: From the Select Patient menu, click the Add Patient button. The Add Patient - Step 1 guidance displays.
Page 168 Exporting, Importing, and Managing Files Database Statistics Figure 8-10: Add Patient - Step 2 Enter a valid date range to search, or un-check Scheduled Procedure Step Start Date and enter any other valid search term. Click Next. The Add Patient - Step 3 guidance displays.
Page 169 Exporting, Importing, and Managing Files Database Statistics Click either the New OCT Recording button or the New FFR Recording button to continue. From a DICOM Storage Server To import patient information From a DICOM Storage Server, complete the following steps: From the Select Patient menu, click the Add Patient button.
Page 170 Exporting, Importing, and Managing Files Database Statistics Figure 8-11: Add Patient - Step 1 (Storage Server) Select DICOM Patient Info. Click the Next button. The Add Patient - Step 2 guidance displays. If there is more than one DICOM Storage Server detected, select the desired server. Click the Next button.
Page 171 Exporting, Importing, and Managing Files Database Statistics Enter a search term such as the Patient Name (shown), Patient ID, or leave blank to return the entire list of Patients. Click the Search button. The results display. Click to highlight the patient, then click the New OCT Recording button or New FFR Recording button.
Page 172 Exporting, Importing, and Managing Files Database Statistics St. Jude Medical 8-32 Part Number ARTUS100109403...
Page 173: Cleaning & Maintenance
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.
Page 174: Contacting St. Jude Medical Service
Cleaning & Maintenance Contacting St. Jude Medical Service Contacting St. Jude Medical Service Service can be contacted at: E-mail: OCTservice@sjm.com Phone: +1 855 478 5833 US Toll-free +1 651 756 5833 International Cleaning Cleaning of the I System consists of: LUMIEN PTIS •...
Page 175: Routine Cleaning Procedure
Cleaning & Maintenance Cleaning Routine Cleaning Procedure The O Integrated DOC, DOC Holster, and Table Side Controller should be cleaned PTIS following the facilities standard cleaning schedule, or at least every 30 days under normal use. Turn off all system components with accessible power controls and unplug the power cables.
Page 176: Maintenance
Cleaning & Maintenance Maintenance Maintenance Maintenance of the system consists of: ™ • Cleaning the optical connection in the DOC and the Dragonfly Imaging Catheter. • Replacing the optical adapter in the DOC. • Inspecting exposed cable connections. • Transferring log files. •...
Page 177: Optical Connection Cleaning Procedure
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.
Page 178 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 Remove the cleaner from the DOC. 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.
Page 179 Cleaning & Maintenance Maintenance Figure 9-2: Inserting Cleaner Into Catheter Remove the cleaner from the Dragonfly. Reconnect the Dragonfly Imaging Catheter to the DOC. Return the system to normal operation. System LUMIEN PTIS Instructions for Use...
Page 180: Optical Adapter Replacement Procedure
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.
Page 181 Cleaning & Maintenance Maintenance Pull the adapter straight out of the DOC. NOTE: 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: Do not touch any of the optical connectors as this may damage them.
Page 182: Cable Connection Inspection Procedure
Cleaning & Maintenance Maintenance Cable Connection Inspection Procedure Make sure the power cords are in good condition and are properly plugged in. If a secondary ground connection is being used, ensure that both ends of the cable are secure. Ensure all other connectors are fully seated and properly secured. St.
Page 183: Transferring Log Files
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.
Page 184 Cleaning & Maintenance Maintenance The Transfer Event Log Files menu opens (Figure 9-5), which lists all the files to be exported. 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.
Page 185: Identifying The Software Version
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 <Ctrl-S> to open the Startup window. The software version information might be required when contacting St. Jude Medical Service. Software version and copyright...
Page 186: User Troubleshooting
Cleaning & Maintenance User Troubleshooting User Troubleshooting Table 9-1 provides basic guidelines for troubleshooting the I System. LUMIEN PTIS “Troubleshooting OCT Acquisition” on page 5-19 explains what to do if a catheter fails during pullback. If your problem is not resolved after attempting the suggested remedies, contact your ser- vice representative or E-mail OCTservice@sjm.com.
Page 187 Cleaning & Maintenance User Troubleshooting Table 9-1: User Troubleshooting Tips (continued) Symptom Possible Causes Remedy Connections During data export, The connected USB Connect only a USB Drive supported by the system does not drive is not compatible Windows 7 SP1. Refer to the instructions list the USB drive with the system, or the for use that came with your USB drive to...
Page 188 Cleaning & Maintenance User Troubleshooting Table 9-1: User Troubleshooting Tips (continued) Symptom Possible Causes Remedy Dirty connection Refer to “Optical Connection Cleaning between DOC and Procedure” on page 9-5 to clean the con- imaging catheter. nection. St. Jude Medical 9-16 Part Number ARTUS100109403...
Page 189: System Disposal
Cleaning & Maintenance System Disposal System Disposal Disposal of the equipment must be in accordance with local laws. System LUMIEN PTIS Instructions for Use 9-17...
Page 190 Cleaning & Maintenance System Disposal St. Jude Medical 9-18 Part Number ARTUS100109403...
Page 191: User Interface Reference
User Interface Reference 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 by selecting the Setup option from the Menu button options on the Select Patient or Patient Summary screen. NOTE: When creating or reviewing an OCT recording, the Settings button opens a context-sensitive OCT Settings menu.
Page 192: Setup - Acquisition Menu
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: Pullback - Performs a recording while the imaging core of the catheter is pulled back within the cathe- Recording Type ter sheath.
Page 193 Pullback Speed Speed settings are limited to 10.0 mm/sec, 20.0 mm/sec, and 25.0 mm/sec. For Dragonfly Duo or OPTIS, available speeds are 18 and 36 mm/sec. Sets the length of the pullback. NOTE: When connected to an original C7 Drag- onfly imaging catheter, the Pullback Length setting is limited to 54 mm.
Page 194: Setup - Acquisition/Other Menu
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.
Page 195: Setup - Administration Menu
User Interface Reference Setup - Administration Menu Setup - Administration Menu Figure 10-3: Setup - Administration Menu Table 10-4: Setup - Administration Menu Settings Click here and enter or clear the institution name. Institution Name Opens the system Date and Time Properties menu. Date and Time Resets all user-entered configuration values except the date and time to the original factory default values.
Page 196 User Interface Reference Setup - Administration Menu Table 10-4: Setup - Administration Menu Settings (continued) Displays current date, system name, institution name, and System Information software version Displays EULA. End User License Resets EULA. The EULA must be accepted upon first Agreement operation after reset in order to access the system.
Page 197: Setup - Database Menu
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.
Page 198 User Interface Reference Setup - Database Menu Table 10-5: Setup - Database Menu Settings (continued) Edit Patient... Click on a patient’s name to edit the patient’s information. See “Edit- ing Patient Information” on page 3-8 for more information. Anonymize... Click on a patient’s name to remove the patient’s identifying informa- tion from the record.
Page 199: Setup - Database/Maintenance Menu
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.
Page 200 User Interface Reference Setup - Database/Maintenance Menu Table 10-6: Setup - Database/Maintenance Menu Settings (continued) Indicates the size of the database file. Database File OCT image files that are referenced by the data- base but could not be found. Click the Clean but- Missing Images ton to remove references to files that cannot be found.
Page 201: Setup - Database/Physician Menu
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 system Shows a list of all physician names entered in the • Click Add to add a new physician name. •...
Page 202: Setup - Dicom Menu
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 Server so that the system can initiate a network con- nection between the two systems.
Page 203 User Interface Reference Setup - DICOM Menu 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 Table 10-8: Setup - DICOM Menu Settings Server Nickname Displays the Nickname for the server.
Page 204 User Interface Reference Setup - DICOM Menu Figure 10-8: Configure DICOM Menu St. Jude Medical 10-14 Part Number ARTUS100109403...
Page 205 User Interface Reference Setup - DICOM Menu Table 10-9: Setup - Configure DICOM Menu Settings Hostname The host name of the network server that contains the Remote DICOM Server. Use this option to identify the server if the network supports the Domain Name System (DNS) and the host name is known;...
Page 206 User Interface Reference Setup - DICOM Menu Table 10-9: Setup - Configure DICOM Menu Settings (continued) Response Timeout (secs) The maximum time to allow for a response from the Remote DICOM Server after sending a DICOM request. The mini- mum setting is 15 seconds while the maximum is 1800. The default is 600 seconds.
Page 207: Setup - Dicom/Image Options Menu
User Interface Reference Setup - DICOM/Image Options Menu Setup - DICOM/Image Options Menu Figure 10-9: Setup - DICOM/Image Options Menu Table 10-10: 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.
Page 208 User Interface Reference Setup - DICOM/Image Options Menu Table 10-10: Setup - DICOM/Image Options Menu Settings (continued) Check to select the image modality: OCT, OT Modality (Other), or US (Ultrasound). The default DICOM export modality is OCT. Check to select the export format for DICOM Photometric Interpretation images: RGB or PALETTE.
Page 209: Setup - Dicom/Local Host Menu
User Interface Reference Setup - DICOM/Local Host Menu Setup - DICOM/Local Host Menu Figure 10-10: Setup - DICOM/Local Host Menu Table 10-11: Setup - DICOM/Local Host Menu Settings Hostname System The name used to identify the I on the network. LUMIEN PTIS This name is shown for display purposes only and cannot be modified.
Page 210 User Interface Reference Setup - DICOM/Local Host Menu Table 10-11: Setup - DICOM/Local Host Menu Settings (continued) 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.
Page 211: Setup - Display Menu
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 indi- cator to use as scale marks. Graduated Cut Plane System...
Page 212 User Interface Reference Setup - Display Menu Table 10-12: Setup - Display Menu Settings (continued) Check this checkbox to add scaled crosshairs to the cross section view. Crosshair On/Off Click the arrow on the Colormap drop-down menu to display the Colormap list of colors.
Page 213: Setup - Measurements Menu
User Interface Reference Setup - Measurements Menu Setup - Measurements Menu Figure 10-12: Setup - Measurements Menu Table 10-13: Setup - Measurements Menu Settings List of pen colors that can be used for subsequent measurements and calculations. If Auto Cycle is selected, the pen color used for measure- Pen Color ments is automatically changed to the next color after a new measure- ment is completed.
Page 214: Setup - Measurements/Labels Menu
User Interface Reference Setup - Measurements/Labels Menu Setup - Measurements/Labels Menu Figure 10-13: Setup - Measurements/Labels Menu Table 10-14: Setup - Measurements/Labels Menu Settings Label text that will be used when making the indi- cated type of measurement. Default Labels Click and type in any field to change that label.
Page 215: Setup - Print Menu
User Interface Reference Setup - Print Menu Setup - Print Menu Figure 10-14: Setup - Print Menu Table 10-15: Setup - Print Menu Settings Click to choose the format used when printing a file to a USB USB File Format drive.
Page 216: Setup - Service Menu
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.
Page 217 NOTE: The service utility is for use by trained Field Service Engi- Field Service Tool neers. A password is required to open the service utility. This feature is not used on the OPTIS Integrated system. External Monitor System LUMIEN PTIS...
Page 218 User Interface Reference Setup - Service Menu Table 10-16: Setup - Service Menu Settings (continued) The Hide Calibration checkbox controls the display of the calibra- tion sequence when a catheter is first connected to the DOC. Calibration Options Checked - The calibration sequence is hidden. Unchecked - The calibration sequence is displayed on screen.
Page 219: Setup - Service/System Diagnostics Menu
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 Med- ical Service monitor and analyze signal levels in the imaging engine either in real time or at the time a recording was made.
Page 220 User Interface Reference Setup - Service/System Diagnostics Menu Table 10-17: Setup - Service/System Diagnostics Menu Settings (continued) 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.
Page 221: Safety Information
Notice No. 50, dated July 26, 2001. NOTE: LightLab Imaging, Inc. hereby declares that OPTIS Integrated system is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. A copy of the Full Declaration of Conformity can be obtained by contacting the EU Representative.
Page 222: Patient Safety
Safety Information Patient Safety Patient Safety The I System is intended for use only by medical personnel trained in its LUMIEN PTIS 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 I LUMIEN PTIS...
Page 223: Operator Safety
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 infor- mation provided in the safety labels that are located on the system (see Figure 11-1), and observe the precautions outlined in this section.
Page 224: Moving The System
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. •...
Page 225: Avoiding Electrical Hazards
• Do NOT use additional cables, extension cords or outlets with the I LUMIEN OPTIS System. NOTE: The I System’s isolation transformer creates an elec-...
Page 226: Making Proper Electrical Connections
Safety Information Making Proper Electrical Connections Making Proper Electrical Connections Ensure the electrical connection for the system is properly rated (see Figure 11-2). Care- fully follow the safety guidelines described in this section when connecting your system’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 reg- ulations and places the patient and the operator at risk of injury or...
Page 227: Explosion Hazard
Safety Information Explosion Hazard Explosion Hazard WARNING: Do NOT operate the I System in the presence of flam- LUMIEN PTIS mable anesthetics. Doing so could lead to an explosion. System Imaging Limitations The I System is intended for use by medical personnel who have received LUMIEN PTIS training in the use of the system.
Page 228: Electromagnetic Compatibility
Safety Information Electromagnetic Compatibility Electromagnetic Compatibility The I System is designed to meet the following electromagnetic compati- LUMIEN PTIS bility standards: • IEC 60601-1-2 (US and 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.
Page 229: Safety Functions Built Into The Ilumien Optis System
Safety Information Safety Functions Built Into the Ilumien Optis System Safety Functions Built Into the I System LUMIEN PTIS The following safety functions have been built into the system: • The system disables light output and disables all motors in these situations: •...
Page 230 Safety Information Safety Functions Built Into the Ilumien Optis System St. Jude Medical 11-10 Part Number ARTUS100109403...
Page 231: System Specifications
System Specifications System - Safety & Regulatory Table 12-1: System Safety & Regulatory Specifications Category Specifications Regulatory Approvals US 510(k) clearance. Safety standards system IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) meets: EN60601-1: 2006, “Medical Electrical Equipment, Part 1: General Requirements for Safety”...
Page 232 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, Type CF shock • DOC with catheter (CF label at DOC cable exit on Con- nector Panel) Degree of protection, Console - IPX0...
Page 233: System - Electrical And Physical
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: <...
Page 234: Imaging Specifications
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 22.6 mW maximum @ 1305 nm ±55 nm Power (Class 1M Laser Output per IEC 60825-1) Visible Laser Optical Power 1.45 mW maximum @ 670 nm (nominal) (Class 1M Laser Output per IEC 60825-1)
Page 235: Ffr Specifications
System Specifications FFR Specifications FFR Specifications Table 12-4: FFR Specifications Parameter Specification AO Pressure (Wi-Box to I System) LUMIEN PTIS Operating pressure -200 to +450 mm Hg Accuracy +/- 1 mm Hg or +/- 1% of reading, whichever is greater PW Pressure Operating pressure -30 to +300 mm Hg...
Page 236: Electromagnetic Emissions
System Specifications Electromagnetic Emissions Electromagnetic Emissions Table 12-5: Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The I System is intended for use in the electromagnetic environment LUMIEN PTIS specified below. The customer or user of the I System should assure LUMIEN PTIS that it is used in such an environment.
Page 237: Electromagnetic Immunity
System Specifications Electromagnetic Immunity Electromagnetic Immunity Table 12-6: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The I System is intended for use in the electromagnetic environment LUMIEN PTIS specified below. The customer or user of the I System should assure LUMIEN PTIS that it is used in such an environment.
Page 238 System Specifications Electromagnetic Immunity Table 12-6: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The I System is intended for use in the electromagnetic environment LUMIEN PTIS specified below. The customer or user of the I System should assure LUMIEN PTIS that it is used in such an environment.
Page 239 System Specifications Electromagnetic Immunity Table 12-7: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The I System is intended for use in the electromagnetic environment LUMIEN PTIS specified in this section. The customer or user of the I System should LUMIEN PTIS assure that it is used in such an environment.
Page 240 System Specifications Electromagnetic Immunity Field strengths from fixed transmitters, such as base stations for radio (cellu- lar/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broad- cast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
Page 241: Recommended Separation Distances
System Specifications Recommended Separation Distances Recommended Separation Distances Table 12-8: Recommended separation distances between portable and mobile RF com- munications equipment and the I System LUMIEN PTIS The I System is intended for use in an electromagnetic environment LUMIEN PTIS in which radiated RF disturbances are controlled.
Page 242: Fcc Statement
Essential Performance Defined by Operating Mode During testing, the OCT Imaging System (MN: C8/OPTIS Integrated) was operating as follows: SSOCT Data Viewer is displaying white noise. The CardioUI Development soft- ware is running. The probe is active and displaying an image. Image on screen is stable and without error.
Page 243 Index Symbols Callout adding, %AS, 7-2, 7-10 position, %DS, 7-2, 7-12 Callouts adding, Catheter Numerics connection to DOC, 4-5, disconnecting from DOC, 5-18 3D Display, 7-23 insertion, 5-13 positioning, 5-13 preparation, purge, Acquisition mode, 10-29 removal, 5-18 Adding Points, 7-18 stop movement, 5-19 Annotation...
Page 244 Index Database Green’s Theorem, create a new patient, import, 8-20 Setup dialog box, 10-7 statistics, 8-26, 10-9 Hazards Database Tab, 10-7 electrical, 11-5 Delete explosion, 11-7 files, 8-23 light emission, 11-3 measurements, 7-19 repetitive strain injury, 11-3 points, 7-18 Home menu, Depth Calibration Marks, 5-16 Diagnostics Tab,...
Page 245 Index L-Mode OCT Procedure caution, catheter connection, cut-plane, 5-16 catheter insertion, 5-13 limitations, catheter positioning, 5-13 measurements and annotations, catheter preparation, Lock LED on DOC, 1-10 completing procedure, 5-18 Log Files, 9-11, 10-26 DOC preparation, Lumen Profile, 7-20 materials and equipment, recording, 5-16 Operator Safety...
Page 246 Index Pullback Standard File Format, parameters, 12-4 Standard Format stop, 5-19 description, trigger, 10-3 Standby View, Pullback motion LEDs on DOC, 1-10 Stop Button on DOC, 1-10 Purge Catheter, System components, features, imaging limitations, 11-7 moving, 11-4 Range power on, playback, 6-11 setup,...
Page 247 Index connection, media, Vessel Imaging, 11-7 Video Connection, Warning, 1-14 Warning, meaning and format, Front-iv Weight, 12-3 White Level, 9-15 Wi-Box cathlab installation, 1-11 Zoom DICOM Viewer, 8-17 measurements, region, 7-15 System LUMIEN PTIS Instructions for Use Index-5...
Page 248 Index St. Jude Medical Index-6 Part Number ARTUS100109403...
Page 250 ARTUS100088927 ARTUS100xxxxxx XX??

St. Jude Medical OPTIS Instructions For Use Manual

System Overview

System Setup

Opening a Patient Record

Performing an FFR Procedure

Performing an OCT Procedure

Reviewing OCT Recordings

Measurements and Annotations

Exporting, Importing, and Managing Files

Cleaning & Maintenance

User Interface Reference

Safety Information

System Specifications

Quick Links

Troubleshooting

Need help?

Questions and answers

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Summary of Contents for St. Jude Medical OPTIS