Leica Microscope Interface for the SealthStation S8 Quick Reference Guide

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English Intended use The Medtronic Navigation microscope bracket is an accessory to the StealthStation™ system. The microscope bracket interfaces with the Leica microscope and StealthStation™ to enable microscope tracking positions during surgical procedures.

Indications for use The StealthStation™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous surgical procedures. The StealthStation™ System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bone, or vertebra can be identified relative to a CT- or MRbased model, fluoroscopy images, or digitized landmarks of the anatomy.

Contraindications None.

Material composition Material contained in product that can cause an allergic reaction: nickel Additional materials of concern information such as REACH, CA Prop 65 or other product stewardship programs, go to www.medtronic.com/productstewardship.

Compatibility The Medtronic Navigation microscope bracket is compatible with Medtronic StealthStation™ S8 image-guided surgery systems and Medtronic navigation instruments.

System level manuals This device can be used with Medtronic image-guided surgery systems. See the StealthStation™ system level manuals and cranial procedure pocket guides for descriptions of patient groups, intended users, potential clinical benefits, side effects, and potential complications.

Qualified microscopes When used with the StealthStation™ S8 system with StealthStation™ S8 Cranial software, the Medtronic Navigation microscope bracket is qualified with the following Leica microscopes: Leica Leica Leica M720 OH5 M530 OH6 M530 OHX

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Leica ARveo

Leica ARveo 8

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Note: The ARveo 8 microscope comes in two different versions. The first version (10449063, 2021) injects HUD into the oculars as well as the microscope monitor. The second version (10449157, 2023) injects HUD only into the microscope monitor. 1: Microscope bracket (9733883)

Warnings Warning: Inspect the microscope bracket for damage and cleanliness before use. If visibly damaged or unclean, do not use the microscope with the StealthStation™ system. Do not attempt to repair it. Warning: Use care when handling the microscope. Do not allow the microscope bracket to collide with anything. Warning: If microscope bracket is damaged during the procedure, abandon use of the microscope with the StealthStation™ system. Warning: Frequently confirm localization accuracy and system responsiveness during navigation. If accuracy degrades, re-register the patient. Refer to the StealthStation™ cranial pocket guides for instructions on how to re-register the patient. Warning: When navigating with the microscope, keep the crosshair in the same ocular that was used to calibrate the microscope. Warning: The device is designed for re-use and is supplied non-sterile. Warning: Use caution and exercise care in order to prevent injury during use. See the corresponding system level manuals and procedure pocket guides for further handling instructions. Warning: To avoid potential exposure to blood-borne pathogens and chemicals, use appropriate Personal Protective Equipment when handling, processing, or disposing of Medtronic devices.

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Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. Caution: Use of the cable with no compatibility label may cause some video distortion with the Leica ARveo 8. Caution: Refer to the StealthStation™ system level manual and system procedure pocket guides for additional instructions, warnings, and cautions.

Setting up equipment 1. Connect the cables. If you are using the Leica M720 OH5, M530 OH6, or Leica ARveo microscope models, follow these steps: a. Connect the serial interface of the StealthStation™ S8 system microscope communication cable to the EXTERN CAN (external CAN) serial port 1 on the Leica control unit. b. Connect the video connector of the StealthStation™ S8 system microscope communication cable to the Video Input port 2 in the Leica control unit. c. Connect the latching push-pull LEMO™ interface of the StealthStation™ S8 system microscope communication cable to the LED LEMO™ cable 3 located in the Leica control unit. d. Connect the orange latching push-pull LEMO™ connector on the other end of the StealthStation™ S8 system communication cable to the orange Microscope port 4 on the side panel of the StealthStation™ S8 system. e. Connect the gray latching push-pull LEMO™ connector on the other end of the StealthStation™ S8 system communication cable to the Instrument B port 5 on the side panel of the StealthStation™ S8 system. Note: Your StealthStation™ S8 cart may not have all of the ports shown in the figure.

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2: Leica M720 OH5, M530 OH6,or Leica ARveo connections to the StealthStation™ S8 system

1 External CAN serial port in Leica control unit 2 Video Input port in Leica control unit 3 LEMO™ cable in Leica control unit 4 Microscope port on StealthStation™ S8 system 5 Instrument B port on StealthStation™ S8 system If you are using the Leica M530 OHX microscope model, follow these steps: a. Connect the serial interface of the StealthStation™ S8 system microscope communication cable to the CAN (external CAN) serial port 1 on the Leica control unit. b. Connect the video connector of the StealthStation™ S8 system microscope communication cable to the Video Input (XGA) port 2 in the Leica control unit. c. Connect the latching push-pull LEMO™ interface of the StealthStation™ S8 system microscope communication cable to the LED LEMO™ (IGS) port 3 located in the Leica control unit. d. Connect the orange latching push-pull LEMO™ connector on the other end of the StealthStation™ S8 system communication cable to the orange Microscope port 4 on the side panel of the StealthStation™ S8 system. e. Connect the gray latching push-pull LEMO™ connector on the other end of the StealthStation™ S8 system communication cable to the Instrument B port 5 on the side panel of the StealthStation™ S8 system. Note: Your StealthStation™ S8 cart may not have all of the ports shown in the figure.

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3: Leica M530 OHX connections to the StealthStation™ S8 system

1 CAN serial port in Leica control unit 2 Video Input (XGA) port in Leica control unit 3 LEMO™ (IGS) port on the Leica control unit 4 Microscope port on StealthStation™ S8 system 5 Instrument B port on StealthStation™ S8 system If you are using the Leica ARveo 8 microscope model, follow these steps: Note: If you have multiple Leica microscopes, only use the cable with the compatibility label on the Leica ARveo 8. a. Connect the DVI end on the VGA-DVI adapter to the IGS IN port on the Leica control unit and connect the interface cable with the compatibility label to the VGA port on the VGA-DVI adapter 1. b. Connect the serial interface of the StealthStation™ S8 system microscope communication cable to the IGS CAN serial port 2 on the Leica control unit. c. Connect the latching push-pull LEMO™ interface of the StealthStation™ S8 system microscope communication cable to the LED LEMO™ cable 3 located in the Leica control unit. d. Connect the orange latching push-pull LEMO™ connector on the other end of the StealthStation™ S8 system communication cable to the orange Microscope port 4 on the side panel of the StealthStation™ S8 system. e. Connect the gray latching push-pull LEMO™ connector on the other end of the StealthStation™ S8 system communication cable to the Instrument B port 5 on the side panel of the StealthStation™ S8 system. Note: Your StealthStation™ S8 cart may not have all of the ports shown in the figure.

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4: Leica ARveo 8 connections to the StealthStation™ S8 system

adapter on Leica control unit IGS IN port with compatibility 1 VGA-DVI labeled interface cable connected

2 IGS CAN serial port on Leica control unit 3 LEMO™ cable in Leica control unit 4 Microscope port on StealthStation™ S8 system 5 Instrument B port on StealthStation™ S8 system 2. Drape the microscope. a. Pull the drape taut over the LED bracket on the microscope head. b. Secure the drape in place with sterile rubber bands. Note: Maintain visibility of the LEDs by making sure that they are clearly visible and unobstructed by the rubber bands and any wrinkles in the drape. 3. Set up tracking. a. In the EQUIPMENT task in the software, make sure that the microscope is connected to the StealthStation™ system. If the microscope equipment card is not displayed, search for the microscope in the All Equipment list and tap [ADD] next to the microscope equipment card. If the microscope equipment card indicates that the microscope is not connected to the StealthStation™ system, refer to “Troubleshooting” on page 18. b. Make sure that the microscope is the only probe in the camera’s field of view to avoid navigational interference.

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c. Position the camera so that both the probe (microscope) and patient reference frame display in the tracking view on the software screen. Note: To ensure visibility of all optical devices, you typically need to aim the camera such that the microscope bracket sits above the intersection of the crosshair in the tracking view. The camera can view the LED bracket straight on or from the side. d. Tap [DONE].

Navigating Warning: Before localizing, verify navigational accuracy of the system. If navigational accuracy is affected, abort use of the system. 1. Verify navigational accuracy. Verify navigational accuracy of the system by comparing points of interest on the software screen to the corresponding points of the patient anatomy. Caution: If using the Leica FL800 NIR fluorescence, reflections or interference may cause a strobing effect on the video recording of the FL800. Reposition the StealthStation™ camera as necessary to adjust the video recording. Note: For the Leica Arveo 8 model 2023, the microscope focal point is calibrated with the microscope in 2D mode and it is recommended to be used in 2D mode. Note: The Leica microscopes do not allow for Heads Up Display (HUD) injection from the StealthStation™ S8 system into the microscope oculars or microscope monitor while utilizing the Leica OH6, OHX, ARveo and ARveo 8 GLOW features. 2. Localize. To “localize” means to identify the location of the tip of a StealthStation™ system probe on the preoperative patient images in the software. When you use the microscope to localize, this “tip” is the anatomical point you observe at the intersection of the crosshair in the focal plane of the microscope. a. Focus the microscope on the anatomy of interest. b. Verify the system responsiveness and accuracy by observing the updated localization site in the images on the software screen. If localization seems inaccurate, follow the instructions in “Focus on a reference frame divot:.” IMPORTANT: Localization at different depths of field (DOF) As magnification is decreased, the DOF increases. A larger DOF will result in objects further above and below the navigated focal point appearing in focus. To narrow the DOF around the navigated focal point, increase microscope magnification. 3. Focus on a reference frame divot:

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Center the crosshair or converging lasers (if equipped) on a reference frame divot, increase magnification to the highest level, and focus the microscope on the bottom of the divot. -

Alternatively, you may focus on the center of the etched divot on the reference frame.

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For non-Heads Up Display interfaces, the localization site is at the intersection of the crosshair installed within the eyepiece (crosshair reticle). Make sure that the crosshair reticle is installed in the microscope. If not, remove the regular eyepiece and replace it with the crosshair reticle eyepiece.

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For HUD enabled interfaces, the localization site is at the intersection of the video-injected crosshair.

Note: The video-injected crosshair is open in the center by default. However, your system can be configured to display a closed crosshair. If you prefer a closed crosshair, contact Medtronic Navigation technical support. 5: Video-injected crosshair; open and closed

6: Reference frame divot

Note: If localization seems inaccurate when you focus on a reference frame divot: -

Make sure that the microscope’s line-of-sight is perpendicular to the divot.

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Make sure that the microscope is focused on the bottom of the divot.

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Make sure that both the probe and patient reference frame display in the tracking view in the software screen.

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Warning: The LED bracket may have been moved or repositioned. Contact Medtronic Navigation to schedule a microscope install calibration. Calibration of the microscope bracket must be performed by a trained service person.

Heads-up display (HUD) Note: HUD is an optional microscope module offered by Leica. The Leica Dual Imaging (DI) module includes HUD capability. Disregard this section if the microscope is not equipped with HUD capability. The StealthStation™ system microscope interface can superimpose navigational information (such as tumor boundaries and surgical plans) on images seen in one of the microscope oculars or microscope monitor. To use HUD mode, first create a tumor model or surgical plan and then use the microscope hand controls to select the desired HUD options.

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Selecting HUD options using the microscope handgrip • To view the selection menu, press the Up, Down, Select, or Back button on the handgrip. • If your microscope has video injection turned on, use the Up, Down, and Select buttons to highlight and select StealthStation View/Off in the menu. • To select the desired HUD option, highlight it in the menu and press the Select button. 7: Leica handgrip functions

1 Up 2 Select 3 Down 4 Back HUD options

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8: Microscope options

• StealthStation View/Full Screen: Injects the StealthStation™ system screen in the microscope oculars or microscope monitor. The shutter of the microscope is closed. • StealthStation View/Quarter Screen: Injects the StealthStation™ system screen in the upper-right quadrant of the microscope oculars or microscope monitor. The shutter of the microscope remains open. • Plans & Annotations/Show Plans: Injects the active surgical plan or plans and annotations if they were added in the PLANNING or NAVIGATION tasks on the StealthStation™ S8 system. -

The plan’s entry and target points display as circles and are joined by a solid line. The segment of the plan above the current focal plane of the microscope is thicker than the segment of the plan below the current focal plane. The plan colors are similar to those displayed on the StealthStation™ system screen.

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An annotation above the current focal plane is semi-transparent. An annotation below the current focal plane is opaque and displays the annotation label. The annotation colors are similar to those displayed on the StealthStation™ system screen.

• Plans & Annotations/Create Plan: Creates a surgical plan in the StealthStation™ S8 Cranial software based on the current position of the microscope. The plan is composed of the microscope’s focal point (the plan target) and the head of the microscope (the plan entry point).

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• Models/Show Silhouettes: Injects the largest cross-section (boundary) of the tumor. This is the maximum extent of the tumor in all planes perpendicular to the line of sight (not just the focal plane). • Models/Show Contours: Injects the cross-section of the tumor at the current focal plane of the microscope. • Single View and Cycle Views: -

Single View: Provides a menu of single-view layout options. Once a singleview layout is selected, the navigation system injects a full screen view of the layout.

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Cycle Views: Switches current injected view to the next view preset. 9: Silhouette (Left), contour (Right)

Video injection of the StealthStation View Note: Disregard this section if the microscope is not equipped with the Leica DI module. Note: Arveo 8 model 2023 microscope does not allow injection of HUD into the oculars. The Leica DI module supports injection of the StealthStation™ application image window into one of the microscope oculars or microscope monitor. Inject video into the same oculars or microscope monitor that was used to calibrate the microscope. Refer to the Leica manufacturer’s instructions for use to adjust the microscope settings for video injection. • To view the selection menu , press the Up, Down, Select, or Back button on the handgrip. • Use the Up, Down, and Select buttons to highlight and select either StealthStation View/Full Screen or StealthStation View/Quarter Screen from the menu. • To exit the Full Screen or Quarter Screen mode, open the HUD menu and select StealthStation View/Off.

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10: Image window injected into right ocular

Video injection options for the StealthStation View • Single View: Displays a single view. The following single-view options appear: -

Axial

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Coronal

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Sagittal

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Probe’s Eye: Shows the plane that is located at the probe tip, perpendicular to the probe. While navigating the microscope, the Probe’s Eye view in the StealthStation™ S8 software will rotate so the top of the view matches the view through the microscope.

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Trajectory 1: Parasagittal or paracoronal

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Trajectory 2: Paraxial

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3D

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2D Guidance: Provides guidance symbols to direct the surgeon along the surgical plan trajectory and to a target location

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Look Ahead: Displays four probe’s eye views (The upper-left view shows the plane perpendicular to the instrument tip. The other three views are 5 mm, 10 mm, and 15 mm beyond the instrument tip.)

• Cycle Views: Switches to the next view preset in the Navigation software • Zoom In: Increases 2D image magnification • Zoom Out: Decreases 2D image magnification

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Status indicators in the HUD view If a warning or error message appears at the bottom of the software screen while the StealthStation View is being injected into the microscope, a message also appears in the oculars or microscope monitor. • When an error message appears on the software screen, “Error” appears in red in the oculars or microscope monitor. • When a warning message appears on the software screen, “Warning” appears in yellow in the oculars or microscope monitor. 11: Status indicator in the HUD view

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Troubleshooting Locate the issue in the table below and follow the action steps. If the symptom persists, contact technical support for assistance. Issue The EQUIPMENT task, shows no communication between the StealthStation™ system and the microscope. Or The INSTRUMENTS task shows the microscope bracket as disconnected. Or The crosshairs and HUD menus do not display in the oculars or microscope monitor.

Action 1. Make sure that the microscope is powered on. 2. Check the cabling path between the StealthStation™ system and the microscope: a. Make sure that the serial interface of the StealthStation™ S8 system microscope communication cable is connected to the EXTERN CAN (external CAN) serial port on the Leica control unit. b. Make sure that the video connector of the StealthStation™ S8 system microscope communication cable is connected to the Video Input port on the Leica control unit. c. Make sure that the LEMO™ interface of the StealthStation™ S8 system microscope communication cable is connected to the LED LEMO™ cable located in the Leica control unit. d. Make sure that the orange LEMO™ connector on the other end of the StealthStation™ S8 system communication cable is connected to the Microscope port on the side panel of the StealthStation™ S8 system. e. Make sure that the gray LEMO™ connector on the other end of the StealthStation™ S8 system communication cable is connected to the Instrument B port on the side panel of the StealthStation™ S8 system.

The microscope displays a red status bar in the NAVIGATION task even though all cables are properly connected.

Position the camera so that both the probe (microscope) and patient reference frame are in the field of view. For optimal positioning, align the camera to the forward right of the surgical area with the microscope tracker in the camera’s field of view. If the problem persists, contact Medtronic Navigation technical support with the part number and serial number of the microscope bracket. The probe geometry error may be too high to use the microscope with the navigation software.

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Disconnecting the interface Leave the microscope LED bracket permanently attached to the head of the microscope. This helps prevent miscalibration. Warning: Removing and reattaching the LED bracket changes the position of the bracket in relation to the microscope. This invalidates the calibration, and a new calibration is required to prevent inaccurate navigation. 1. Disconnect cables from the StealthStation™ system. Disconnect the microscope communication cables from the StealthStation™ system side panel ports or instrument interface (breakout) box. 2. Disconnect cable from the microscope. Disconnect the microscope communication cables from the microscope. 3. Store cables. Coil and secure the cables on the microscope using Velcro™ ties.

Maintenance 1. Make sure that the microscope bracket is securely mounted to the microscope. If the microscope bracket is not securely mounted, contact Medtronic Navigation. 2. Clean the microscope bracket. a. Refer to Table 1 for compatible disinfectants and recommended chemistries. Table 1: Compatible cleaner and disinfectant chemistries Disinfectant type

Disinfectant level

Quaternary ammonium germicidal detergent solution

Low level

Phenolic germicidal detergent solution

Low level

Isopropyl alcohol

70%

Sodium hypochlorite

Low level (5.25% to 6.15%)

b. Wipe and clean the external surfaces of the microscope bracket with a moistened low-level disinfectant wipe per the disinfectant manufacturer’s instructions. If a premoistened wipe is not available, use a clean wipe and moisten with the disinfectant. Do not over saturate the wipe so much that liquid can enter any openings. Warning: Prevent fluid from entering any openings on the microscope bracket. c. Wipe the external surfaces with a clean wipe moistened with water or 70% isopropyl alcohol to remove disinfectant residue on the microscope bracket. d. Allow the microscope bracket to air dry completely before reusing. e. Visually inspect the microscope bracket for cleanliness. If visible soil or residue remains, repeat the steps to clean the microscope bracket. 19

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3. Visually inspect the microscope bracket for damage. Make sure that the microscope bracket does not have any of the following indications of damage: -

Illegible etchings or markings

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Visible cracking or bending

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Discoloration, corrosion, stains or rust

If visibly damaged, the microscope bracket is at the end of its useful life and should not be used with the StealthStation™ system. 4. Clean the microscope interface cables. a. Refer to the following table for compatible disinfectants and recommended chemistries for the microscope interface cables. Table 2: Microscope interface cable disinfectants Disinfectant type

Disinfectant level

Quaternary ammonium germicidal detergent solution

Low level

Phenolic germicidal detergent solution

Low level

Isopropyl alcohol

70%

Sodium hypochlorite

Low level 5.25% to 6.15%

b. Power down and unplug the system before performing cleaning or disinfection procedures. c. Unplug external cables. d. Clean the cable by wrapping a low-level disinfectant wipe completely around the cable starting at one connector. Warning: Do not allow liquid to enter the interior surfaces of the connector. e. Wipe the cable from end to end by pulling the cable through the wipe. Ensure contact with the connector, bend relief, and cable. f. If disinfection is desired, make sure that the surface to be disinfected remains in contact with the disinfectant for the specified contact time as directed by the manufacturer. • The contact time refers to the minimum amount of time the surface needs to remain visibly wet. • Use additional wipes, if needed, to maintain continuous contact time with the disinfectant. g. Examine the surfaces for visible soil. If soil is present, repeat cleaning. h. Wipe the external surfaces with a clean wipe moistened with water or 70% isopropyl alcohol to remove disinfectant residue.

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Specifications Table 3: Microscope bracket (9733883) specifications Operating temperature

18° to 33°C (64° to 91°F)

Storage temperature

-29° to 60°C (-20° to 140°F)

Relative humidity

10% to 80% Non-condensing

Storage Ensure equipment and packaging are dry before storing. Store in dry, clean conditions at ambient room temperature such that the equipment and packaging are not compromised.

Disposal When the device shows visible signs of wear, it is at the end of its useful life. Dispose of it in accordance with your facility’s procedure for medical devices and national regulations.

Contact information If a serious incident occurs in relation to the use of this device, report it to Medtronic Navigation. If a serious incident occurs in the European Union, also report it to the competent authority in the Member State where the incident occurred.

Assistance For questions about the device or to order accessories, contact your Medtronic Navigation representative, or call Medtronic Navigation, Inc. at +1 800 595 9709 in the USA or +1 720 890 3160 for technical support. Leica and ARveo are trademarks of Leica Microsystems IR GmbH. LEMO™ is a trademark of INTERLEMO HOLDING S.A. Velcro™ is a trademark of Velcro Industries B.V.

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