Medtronic 9733469 Instructions for Use

9735730
G02 Rev. A
2020-11
Emitter Quick Reference Guide
Intended use/Indications for use
These devices are accessories for use with the StealthStation™ S8 System. Refer to the StealthStation contraindications.
Description
This quick reference guide provides an overview of the side-mount and flat emitters for use with the StealthStation warnings and precautions, refer to the StealthStation™ S8 System Manual (9735573).
Compatibility
The side-mount and flat emitters are compatible with Medtronic image-guided surgery systems and Medtronic navigation instruments.
S8 System Manual (9735573) for a full list of indications and
S8 system. For more information, including all
Material composition
Material contained in product that can cause an allergic reaction: Nickel
For additional materials of concern information such as REACH, CA Prop 65, or other product stewardship programs, go to www.medtronic.com/productstewardship.
System level manuals
These devices can be used with Medtronic image-guided surgical systems. See the StealthStation descriptions of patient groups, intended users, clinical benefits, side effects, and potential complications disclosure statements. These devices are accessories to your StealthStation
system level manuals and the procedure pocket guides for
system.
Field of navigation
Warning: Visually inspect the emitters before use. Do not use an emitter that is
visibly damaged.
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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Emitter Quick Reference Guide
Low-energy magnetic field: Minimize the amount of metal in this field. Metal objects such as instrument stands, equipment carts, surgical lights, and viewing screens in
1
this area will reduce the navigation field size.
Side-mount emitter
2
Navigation field
3
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.
9735730 G02 Rev. A 3
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 objects such as instrument stands, equipment carts, surgical lights, and viewing
1
screens in this area will reduce the navigation field size.
Flat emitter
2
Navigation field
3
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.
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Emitter Quick Reference Guide
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
1
Fully radiolucent
2
Fluoroscopically radiolucent
Recommended emitter
Flat emitter or side-mount emitter
Flat emitter or side-mount emitter
Details
Fully radiolucent tables do not have any metal around the patient head and torso.
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.
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.
9735730 G02 Rev. A 5
Emitter Quick Reference Guide
Type of surgical table
3
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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