Stealth-Midas MR8 Emitter Quick Reference Guide Rev A Nov 2020

Emitter Quick Reference Guide

Warning: Do not use the side-mount emitter or the flat emitter in ambient (room) temperatures greater than 30°C (86°F). Exceeding this temperature limit could result in navigational inaccuracy or patient or user harm from excessive temperatures. Warning: If the flat emitter is left in the storage bin during system use, it can reach 56°C (133°F). In this condition, allow the flat emitter to cool for five minutes outside of the storage bin before patient contact. Caution: For procedures performed with the flat emitter, a surgical table with a radiolucent table top is recommended. If the surgical table has a metal frame or metal side rails, position the flat emitter at least 5 cm (2 in) away from the metal. Positioning the emitter closer may result in reduced navigational accuracy and volume. Caution: If the surgical table to be used with the side-mount emitter has a metal frame or metal side rails, position the side-mount emitter at least 25 cm (10 in) away from the metal. Positioning the emitter closer may result in reduced navigational accuracy and volume. Caution: Refer to the StealthStation™ system level manual and procedure pocket guides for additional instructions, warnings, and cautions.

Side-mount emitter navigation field The side-mount emitter produces a low-energy magnetic field that encompasses the emitter. Minimize the amount of metal placed in this field. The navigation field, the portion of the magnetic field that is appropriate for navigation, begins 8 cm (3 in) from the emitter face and has a cubical volume of approximately 31.0 cm x 46.0 cm x 46.0 cm (12.2 in x 18.1 in x 18.1 in) (length x width x height). For best results, place the patient in the center of the navigation field.

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Low-energy magnetic field: Minimize the amount of metal in this field. Metal objects

1 such as instrument stands, equipment carts, surgical lights, and viewing screens in this area will reduce the navigation field size.

2 Side-mount emitter 3 Navigation field

Note: This navigation field size is based on testing with a fluoroscopically radiolucent surgical table with non-magnetic metal rails 3 cm to 6 cm tall by 1 cm to 3 cm wide (1.2 in to 2.4 in tall by 0.4 in to 1.2 in wide) and a 25 cm (10 in) separation between the metal rails and the side-mount emitter.

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Emitter Quick Reference Guide

Flat emitter navigation field The flat emitter produces a low-energy magnetic field that encompasses the emitter. Minimize the amount of metal placed in this field. The navigation field, the portion of the magnetic field that is appropriate for navigation, begins 5 cm (2 in) from the emitter face and extends approximately 40.0 cm x 40.0 cm x 37.5 cm (15.7 in x 15.7 in x 14.8 in) (length x width x height). For best results, place the patient in the bottom center of the navigation field.

Low-energy magnetic field: Minimize the amount of metal in this field. Metal

1 objects such as instrument stands, equipment carts, surgical lights, and viewing screens in this area will reduce the navigation field size.

2 Flat emitter 3 Navigation field

Note: This navigation field size is based on testing with a fluoroscopically radiolucent surgical table with non-magnetic metal rails 3 cm to 6 cm tall by 1 cm to 3 cm wide (1.2 in to 2.4 in tall by 0.4 in to 1.2 in wide) and a 5 cm (2 in) separation between the metal rails and the flat emitter. 4

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Surgical tables and emitter selection Refer to the following table for information about using the flat emitter or side-mount emitter with different types of surgical tables. Before surgery, try the emitter setup with the surgical table to be used, and make sure that the software can track the instrument and the patient reference frame throughout the range of locations required for registration and navigation. Refer to “Refining emitter position” on page 15 for more information.

Type of surgical table

Recommended emitter

Details Fully radiolucent tables do not have any metal around the patient head and torso.

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Fully radiolucent

Flat emitter or side-mount emitter

Using a fully radiolucent surgical table instead of a fluoroscopically radiolucent table will significantly extend the navigation field above the flat emitter and will slightly extend the navigation field in front of the side-mount emitter. Fluoroscopically radiolucent tables do not have any metal directly under the patient head and torso.

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Fluoroscopically radiolucent

Flat emitter or side-mount emitter

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When using the flat emitter, a separation greater than 5 cm (2 in) between the emitter and the metal rails on the table will significantly extend the navigation volume above the flat emitter. When using the side-mount emitter, a separation greater than 25 cm (10 in) between the emitter and the metal rails on the table will slightly extend the navigation volume in front of the sidemount emitter.

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Emitter Quick Reference Guide

Type of surgical table

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Non-radiolucent

Recommended emitter

Side-mount emitter (variable outcomes)

Details Non-radiolucent tables and ENT chairs have variable outcomes with EM navigation. The flat emitter is not recommended for use with nonradiolucent tables and ENT chairs. Use of the side-mount emitter may be possible. Position the side-mount emitter away from metal in the surgical tables and chairs for best results.

Setting up the side-mount emitter Connect the side-mount emitter cable to the emitter port on the main cart localization I/O panel. Warning: Do not place the side-mount emitter in contact with the patient because the emitter temperature may reach 48°C (118°F). Caution: Visually inspect all accessory devices before use. Do not use accessory devices if they are visibly damaged. Caution: Procedures performed with the side-mount emitter require a surgical bed featuring side rails because the arm assembly that supports the emitter connects to the side rails.

Cranial procedures Set up the side-mount emitter where it will not interfere with the surgeon’s access to the patient during surgery. 1. Secure the Short Bedrail Adapter (9732566) to the rail of the surgical table. Note: If the surgeon is right-handed, set up the emitter on the left-hand side. For a left-handed surgeon, set it up on the right-hand side.

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2. Connect the Emitter Support Bracket (9735547) to the Vertek™ Articulating Arm (9734252) using the thumb screw.

1 Thumb screw 3. Lock the articulating arm knobs and attach it to the bedrail adapter. Make sure that the starburst teeth mesh together. 4. Place the emitter in the support bracket with the StealthStation™ logo oriented up and make sure that the emitter snaps into place. 5. While supporting the emitter, release the articulating arm locking knob and adjust the position of the emitter. a. Position the emitter about 25 cm (10 in) above the metal on the table and about 20 cm (8 in) from the center of the patient’s head. As a general rule, the space between the patient’s head and the emitter face should be approximately equal to the width of your fist.

b. Aim the emitter at the center of the patient’s head as if aiming a flashlight. 6. Tighten the locking knob of the articulating arm.

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Emitter Quick Reference Guide

1 Example of incorrect setup (too much metal near the navigation field) 2 Example of correct setup ENT procedures Set up the side-mount emitter where it will not interfere with the surgeon’s access to the patient during surgery.

Connect the side-arm support bracket (optional) You can use a side-arm support bracket (9735833) to attach the emitter holder to the main cart instead of attaching it to the bedrail on the operating table. 1. Connect the side-arm support bracket to the docking coupler on the rear of the main cart. 2. Make sure that the knob on the side-arm support bracket is facing down. 3. Tighten the knob to make sure that the side-arm support bracket is securely connected to the cart.

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Set up the emitter holder 1. Connect the emitter support bracket (9735547) to the emitter holder (9735702). 2. Attach the emitter holder clamp (9733469) to the OR table or to the side-arm support bracket (9735833) on the main cart by sliding the holder clamp over the end of the mounting rail. 3. Insert the holder post into the clamp and tighten the handle.

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Emitter Quick Reference Guide

4. Loosen the two ball joint tightening knobs and position the holder. Note: Exact placement of the emitter holder depends on many factors including the type of table, procedure, patient location, and patient size. Use a configuration that suits your situation. For best results, follow these practices: a. Orient the ball joints as far away from the emitter’s electromagnetic field as possible. b. Make sure that no part of the holder extends into the electromagnetic field. c. Position the holder at least 25 cm (10 in) above the metal on the OR table and point it toward the trackers.

1 Example of incorrect setup (holder extends into the electromagnetic field)

2 Example of correct setup 3 Example of correct setup 5. Tighten the two ball joint knobs. Warning: Always loosen the knobs before adjusting the emitter holder. 6. Place the side-mount emitter in the emitter support bracket with the StealthStation™ logo oriented up and make sure that the emitter snaps into place.

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Note: For FESS and Endoscopic Skull Base procedures, the emitter is most effective when it points directly at the patient’s nose and is between 15 and 25 cm (6 and 10 in) away from the nose.

Note: For Lateral Skull Base procedures, the emitter is most effective when it points at the patient’s ear and is between 10 and 20 cm (4 and 8 in) away from the ear.

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Emitter Quick Reference Guide

Setting up the flat emitter for Cranial or ENT procedures Warning: Do not exceed the maximum weight load of 6.5 kg (14 lbs) on the flat emitter. Warning: If the flat emitter is left in the storage bin during system use, it can reach 56°C (133°F). In this condition, allow the flat emitter to cool for five minutes outside of the storage bin before patient contact. Connect the flat emitter cable to the emitter port on the main cart localization I/O panel. 1. Place the flat emitter at the head of the surgical table and position it at least 5 cm (2 in) above the metal of the surgical table with the StealthStation™ logo oriented up. Note: Do not place the flat emitter directly on the metal of the surgical table, and do not place the flat emitter over the pedestal of the surgical table.

2. Make sure that the flat emitter cable rests off to the side of the surgical table and does not interfere with the surgeon’s access to the patient during surgery. Note: Make sure that there is no tension on the flat emitter cable. 3. Drape the flat emitter before placing the patient on the emitter. Refer to “Draping the flat emitter” on page 14. 4. For best results, place the patient in the bottom center of the navigation field. To achieve this placement, position the patient as close as possible to the top of the flat emitter and centered horizontally in the top grooves.

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Low-energy magnetic field: Metal objects, such as surgical lights, in this

1 area will reduce the size of the navigation field. 2 Towel for patient comfort

Location to place additional padding, if necessary, to increase the

3 separation distance between metal rails on the table and the flat emitter 4 Thin pad: 2.5 cm (1 in) or less

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Emitter Quick Reference Guide

Draping the emitters Warning: The side-mount emitter, the flat emitter, and the arm assembly that supports the side-mount emitter are not intended for sterile contact or patient interaction. If you place these items in the sterile field, bag or drape them.

Draping the side-mount emitter 1. Drape the side-mount emitter, arm assembly, and bedrail adapter. 2. If you are using the Medtronic drape (9731831 or 9732571), cuff the drape using the tabs.

1 Draped side-mount emitter 3. Leave some space in the drape around the locking knob to allow for repositioning. Warning: Use care to avoid damaging the drape when re-adjusting the Vertek™ articulating arm.

Draping the flat emitter Drape the flat emitter before placing the patient on the emitter. 1. Place a drape over the flat emitter. 2. Make sure the drape completely covers the flat emitter. Note: For patient comfort, you can place a sterile head cushion on the center of the flat emitter. Make sure that the cushion is centered on the etched crosshairs on the flat emitter. A sterile gel pad can also be placed below the flat emitter for shoulder positioning. 14

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Emitter Quick Reference Guide

Refining emitter position Before setting up for sterile navigation, check the geometry error metric in the software. For best results, minimize the geometry error metric by adjusting the emitter’s position or by positioning the patient closer to the emitter. 1. Connect an instrument to any port on the EM interface. 2. In the INSTRUMENTS, REGISTRATION, or NAVIGATION task, tap the emitter button to open the tracking view, if it is not already open. 3. Tap [OPEN TRACKING DETAILS] to display the tracking details. 4. Confirm that the emitter and instrument interface (breakout box) are connected to the system. 5. Make sure that the software can track the instrument and the patient reference frame throughout the range of locations required for registration and navigation. 6. Adjust the position of the emitter as necessary until the instrument and patient reference frame display in the tracking view. For the flat emitter, if your volume is smaller than expected, decrease the padding thickness between the patient and the emitter, or add padding between the emitter and the metal on the surgical table. Gradually increase the separation distance between the emitter and the metal by a centimeter or more while maintaining proper patient positioning, and re-evaluate the volume.

Storing the emitters When the emitters are not in use, store them in their transport positions on the system cart. Refer to the StealthStation™ S8 System Manual (9735573) for instructions on storing the emitters. If you are using a side-arm support bracket, you can adjust the emitter holder to rest off to the side of the system main cart. Caution: Do not disassemble the emitter holder or the emitter holder clamp.

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Emitter Quick Reference Guide

Troubleshooting Symptom

Troubleshooting steps

The instrument is not tracking in the software and displays a high geometry error metric.

• Make sure that the instrument is no more than 39.0 cm (15.4 in) from the face of the side-mount emitter or no more than 42.5 cm (16.7 in) from the face of the flat emitter. • Move any devices that emit electromagnetic noise (such as electric drills and electrocautery devices) away from the instrument. • Move any metal objects (such as the endoscope’s camera) farther away from the instrument.

Cleaning the system Caution: Clean the emitter holder, emitter support bracket, and emitter holder clamp prior to first use and after each use. Caution: The emitter holder, emitter support bracket, and emitter holder clamp and support bracket are not designed for sterilization and may be damaged if sterilization is attempted. If you are using the Vertek™ arm, refer to the Vertek™ Articulating Arm Package Insert (9734252-99) for general cleaning and sterilization instructions. For instructions on cleaning the emitters, refer to the StealthStation™ S8 cleaning instructions (9735727).

Disposal Refer to the system level manual for instructions on how to properly dispose of your system. 16

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

Assistance If you have questions about the side-mount emitter or the flat emitter, call Medtronic Navigation at +1 800 595 9709 in the USA or +1 720 890 3160 for technical support. Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. +31 45 566 80 00

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