Intuitive DAVINCI Xi User Manual Addendum
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Intuitive DAVINCI Xi User Manual Addendum

Firefly imaging system
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| Xi | X
Firefly Imaging
System User Manual
Addendum
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 USA
intuitive.com
intuitive.com
PN 552064-10 Rev. A 2022.05

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  • Page 1 | Xi | X intuitive.com Firefly Imaging System User Manual Addendum Intuitive Surgical, Inc. PN 552064-10 Rev. A 2022.05 1266 Kifer Road Sunnyvale, CA 94086 USA intuitive.com...
  • Page 2 ©2022 Intuitive Surgical Operations, Inc. All rights reserved. Trademarks Intuitive , Intuitive Surgical , da Vinci, and Firefly are trademarks or registered trademarks of Intuitive Surgical. Product and brand names/logos are trademarks or registered trademarks of Intuitive Surgical or their respective owner. See www.intuitive.com/trademarks.

  • Page 3: Table Of Contents

    Table of Contents Table of Contents Introduction ............................ 4 Indications for Use.........................4 Safety Information for Indocyanine Green..................4 System Overview ..........................6 System Components ........................7 Indicators ............................7 Firefly Imaging Operation ......................12 Connecting the Endoscope to the Endoscope Controller.............. 12 Select the Visualization Mode ...................... 13 Adjust Image ..........................

  • Page 4: Introduction

    Introduction Introduction This addendum to the da Vinci Xi System User Manual and the da Vinci X System User Manual provides details specific to the Firefly Imaging System. Note: Aspects of the da Vinci Firefly Imaging System not addressed in this document are the same as for the da Vinci Vision system.
  • Page 5 Introduction | Safety Information for Indocyanine Green ICG Warnings and Precautions For information on imaging agent precautions, warnings, and contraindications, refer to the imaging agent labeling. WARNING: Hypersensitivity reactions including anaphylaxis, urticaria, and deaths due to anaphylaxis have been reported following intravenous administration of indocyanine green. Always have cardiopulmonary resuscitation personnel and equipment readily available and monitor all patients for hypersensitivity reactions.

  • Page 6: System Overview

    Only use ICG at indicated doses and concentrations as defined in the imaging agent labeling. Note: Firefly Sensitive mode is not available with all endoscopes. Contact your Intuitive representative for additional information. In Standard mode, the system displays the resulting images as a fluorescent (green) overlay on a black and white background image.

  • Page 7: System Components

    System Overview | System Components System Components Figure 1 da Vinci system with Firefly imaging components (example) 1. 0 degree or 30 degree surgical endoscope 2. Endoscope Controller Note: The Firefly Imaging System is a fully integrated part of the da Vinci Surgical System (da Vinci system).
  • Page 8 System Overview | Indicators • The Endoscope Controller LED indicates the power status of the Endoscope Controller. Table 1 Endoscope Controller Endoscope Controller LED Status No Power Failure Blue, Flashing Powering up Blue, Steady Powered and ready • The Endoscope Cable Connection LED indicates when an endoscope is connected and ready for use.
  • Page 9 System Overview | Indicators Figure 3 Laser safety label (example) 1. “LASER ON” illuminates when Firefly imaging is active Endoscope Indicators Endoscope Laser Aperture Label The endoscope laser aperture label points in the direction that laser light is emitted. Figure 4 Laser aperture label (example) 1.
  • Page 10 System Overview | Indicators Figure 5 Endoscope LED (example) 1. Endoscope LED Table 4 Endoscope LED Endoscope LED Status Endoscope is not connected to the Endoscope Controller. Green, Flashing Endoscope is connected to the Endoscope Controller and the system is loading calibration data. Green, Steady Endoscope is connected to the Endoscope Controller and cali- bration data is fully loaded.
  • Page 11 System Overview | Indicators Figure 6 LASER ON indicator 1. LASER ON indicator Table 5 Laser ON Indicator Laser Safety Label LED Status Off, LED is not illuminated Firefly imaging is not activated On, LED is illuminated Firefly imaging is active Surgeon Console 3D Viewer and Vision Cart Touchscreen On the Surgeon Console 3D viewer and the Vision Cart touchscreen, the “LASER ON”...

  • Page 12: Firefly Imaging Operation

    Firefly Imaging Operation Firefly Imaging Operation WARNING: Ensure adequate illumination of the operative field while using fluorescence imaging modes. Failure to do so may lead to false positive interpretation of the image, which can result in ischemia, or false negative interpretation of the image that can result in unplanned removal of healthy tissue.

  • Page 13: Select The Visualization Mode

    • Firefly Fingerswitch • Firefly Intensity • Background Brightness • Sensitive Mode Note: Sensitive mode is not available with all endoscopes. Contact your Intuitive representative for additional information. Note: Sensitive Mode Operation on page for specific instructions on activating and using Firefly imaging in Sensitive mode.
  • Page 14 Firefly Imaging Operation | Select the Visualization Mode On the Surgeon Console touchpad Instrument tab, in the endoscope arm pod, the surgeon can activate Firefly and adjust background brightness. On the Vision Cart touchscreen Display tab, the surgeon can activate Firefly and adjust the Firefly image: •...
  • Page 15 Firefly Imaging Operation | Select the Visualization Mode 3. Touch the Firefly Mode ON button. If Firefly is already activated, touching the OFF button deactivates Firefly and the system reverts to visible light imaging. Figure 10 Surgeon Console Firefly Mode OFF/ON button 1.
  • Page 16 Firefly Imaging Operation | Select the Visualization Mode 2. Touch the Firefly OFF button. If Firefly is already activated, touching the ON button deactivates Firefly. Figure 12 Vision Cart Firefly OFF/ON button 1. Firefly button Toggle Between Firefly and Visible Light Imaging Firefly Fingerswitch The ability to use the hand control finger clutches to toggle between visible light and Firefly imaging is set at the Surgeon Console touchpad.
  • Page 17 Firefly Imaging Operation | Select the Visualization Mode Hand Control Finger Clutches While pressing and holding the endoscope control pedal, use the finger clutches on either of the hand controls to toggle between visible light imaging and Firefly imaging. Figure 14 Switching modes at Surgeon Console 1.

  • Page 18: Adjust Image

    Firefly Imaging Operation | Adjust Image The illumination button cannot be used to activate Firefly imaging. In order to activate Firefly imaging, use the Firefly OFF/ON button on either the Surgeon Console touchpad or the Vision Cart touchscreen. Table 6 Illumination Button Illumination State Press and Hold Button Visible light is ON...
  • Page 19 Firefly Imaging Operation | Adjust Image Image Adjustment on Surgeon Console Firefly Intensity Slider The Firefly Intensity slider adjusts the visibility of the green fluorescing image relative to the non-fluorescing image (black and white). This slider is enabled in Firefly imaging and disabled when the system is in visible light mode (when Firefly is deactivated).
  • Page 20 Firefly Imaging Operation | Adjust Image 3. Touch Close to exit the Brightness screen. Figure 17 Instrument Tab Brightness slider 1. Background Brightness screen In the Firefly section of the Settings tab when Firefly is activated: 1. Touch the Settings tab, then touch the Firefly button or scroll to view the Firefly section. 2.
  • Page 21 Firefly Imaging Operation | Adjust Image Restore Settings to Factory Defaults The following Firefly settings can be reset to factory default values. • Brightness: 50% (of full slider value) • Firefly Intensity: 50% (of full slider value) • Firefly Background Brightness: 50% (of full slider value) In the Firefly section of the Settings tab when Firefly is activated: 1.
  • Page 22 Firefly Imaging Operation | Adjust Image Figure 20 Vision Cart Firefly Intensity slider 1. Firefly Intensity slider Brightness Slider On the Display tab, move the Brightness slider to change the background brightness when Firefly is activated. This slider also adjusts image brightness in visible light mode (when Firefly is deactivated).

  • Page 23: Sensitive Mode Operation

    Sensitive Mode Operation Sensitive Mode Operation Note: Sensitive mode is not available with all endoscopes. Contact your Intuitive representative for additional information. Sensitive mode increases the fluorescent sensitivity of the Firefly Imaging System, which enables visual detection of lower concentrations of fluorescent imaging agents. Sensitive mode increases the sensitivity by turning off the illumination used to create the gray scale (black and white) background images observed in Standard mode.

  • Page 24: Select Sensitive Mode

    Sensitive Mode Operation | Select Sensitive Mode Figure 22 Image in Firefly Standard mode and in Sensitive mode (example) 1. Standard mode 2. Sensitive mode Select Sensitive Mode When the appropriate endoscope is installed, the Sensitive Mode option is available at the bottom of the Firefly section of the Settings tab.
  • Page 25 Sensitive Mode Operation | Select Sensitive Mode Activate Sensitive Mode at Surgeon Console Surgeon Console Touchpad - Settings Tab 1. In the Firefly section of the Settings tab, scroll down and touch the Show Controls button in the Sensitive Mode option (Figure 23).
  • Page 26 Sensitive Mode Operation | Select Sensitive Mode Figure 24 Sensitive mode options 1. Sensitive mode button 2. Scroll down to see the Firefly Black Point control slider and Sensitive Mode Show Controls button 3. Show Controls button 4. Firefly Black Point slider Note: Touching Hide Controls while in Sensitive mode reverts Firefly imaging to Standard mode.
  • Page 27 Sensitive Mode Operation | Select Sensitive Mode Surgeon Console Touchpad - Endoscope Arm Pod 1. In the Firefly section of the Settings tab, scroll down and touch the Show Controls button in the Sensitive Mode option. 2. On the Instrument tab endoscope arm pod, touch the Firefly button to cycle among OFF (turn off Firefly and revert to visible light imaging), Standard mode, and Sensitive mode.

  • Page 28: Adjust Image In Sensitive Mode

    Sensitive Mode Operation | Adjust Image in Sensitive Mode Touch the Firefly Fingerswitch button to ON. When this button is ON, the surgeon can cycle among OFF (turn off Firefly and revert to visible light imaging), Standard mode, and Sensitive mode by using the endoscope control pedal and the hand control finger clutches.
  • Page 29 Sensitive Mode Operation | Adjust Image in Sensitive Mode Image Adjustment on Surgeon Console Firefly Intensity Slider Drag the Firefly Intensity slider to adjust the intensity of the green fluorescent signal. Moving it to the right progressively increases the intensity of the fluorescent signal (appears more saturated). Figure 29 Surgeon Console Firefly Intensity slider, in Sensitive mode (example) 1.
  • Page 30 Sensitive Mode Operation | Adjust Image in Sensitive Mode Firefly Imaging Operation on page 12, and Image Adjustment on Vision Cart Touchscreen on page for general instructions on using the Firefly Intensity slider on the Vision Cart touchscreen. Firefly Black Point Note: Firefly Black Point control is available only in Sensitive mode.

  • Page 31: Instrument Function During Sensitive Mode

    Sensitive Mode Operation | Instrument Function During Sensitive Mode Instrument Function During Sensitive Mode Instrument Motion Most anatomy is not visible in Sensitive mode. If instruments are in motion while Sensitive mode is selected, the system automatically switches to Standard mode, the black-and-white background displays, and the intensity of the Sensitive mode fluorescent signal decreases.

  • Page 32: Troubleshooting And Service

    Endoscope is off the turn off the source, restart the system when arm. safe to do so. 3. If the problem persists, contact Intuitive Customer Service. Fluorescence image On the Surgeon Console touchpad, touch the • Firefly laser may not...
  • Page 33 Troubleshooting and Service | Troubleshooting Figure A.1 Illumination button on endoscope (example) 1. Illumination button Table A.2 Firefly Sensitive Mode Troubleshooting Symptom Reason Action Cannot save Sensitive If a user account is not Make sure you are logged into a Surgeon mode settings used, Surgeon Console Console user account when pressing Show...

  • Page 34: Firefly Laser Test Procedure

    Endoscope limitations. Use another Intuitive endoscope with Sensitive mode capability. A.2 Firefly Laser Test Procedure If the Firefly laser is not operating, follow these steps to test it: 1.

  • Page 35: Safety And Symbols

    Safety and Symbols Appendix B Safety and Symbols B.1 Safe Use Light Safety WARNING: Avoid looking at light emitted directly from the endoscope or the light guide, to prevent eye injury. The warning label contains specifications for near-infrared (NIR) radiation emitted in Firefly imaging. WARNING: Do not examine optical fiber ports or optical fibers that are connected to a light source with optical instruments (for example, a magnifying glass), to prevent eye injury.

  • Page 36: Symbols And Icons

    Safety and Symbols | Symbols and Icons Table B.1 Warning Label (example) (continued) Label Location INVISIBLE LASER RADIATION AVOID DIRECT EYE EXPOSURE CLASS 3R LASER PRODUCT Maximum Output: 124 mW at Wavelength: 805 nm Device classified per IEC 60825-1:2007 Complies with 21 CFR 1041.10 and 1040.11 except for deviations pursuant to Laser Notice No.
  • Page 37 Safety and Symbols | Symbols and Icons Table B.3 Symbols Used in This Manual (continued) Symbol Meaning Warning: Alerts the reader about a situation which, if not avoided, could result in death or serious injury. Federal (U.S.) law restricts this device for sale, distribution, and use by or on the order of a physician.

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