The Pneumatic Stealth-Midas Legend SystemInstructions for Use PDF download

Instructions for Use 175034ML55 F

The Pneumatic Stealth-Midas™ Legend™ System El sistema neumático Stealth-Midas™ Legend™

Instructions for Use ES Instrucciones de uso

Instructions for Use

The Pneumatic Stealth-Midas™ Legend™ System

Customer service For further information regarding the use of this product or to report any problems, contact Medtronic Customer Service, or contact your local distributor sales representative or call:

Medtronic Neurosurgery Service Group 4620 North Beach Street Fort Worth, Texas 76137 USA

800 335 9557 or 817 788 6440 [email protected] International Service: International Customers should contact their local Medtronic representative. The information contained in this document is accurate at time of publication. Medtronic reserves the right to make changes to the product described in this manual. Refer to manuals.medtronic.com for the current version.

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Contents Glossary�� 1 General information�� 1 Pneumatic Stealth-MidasTM LegendTM System description�� 1 Pneumatic motors�� 1 Attachments�� 1 Surgical dissecting tools�� 1 System accessories�� 1 Indications for use�� 1 Target patient population�� 1 Intended use�� 1 Clinical benefits�� 1 Contraindications�� 1 Warnings�� 2 Precautions�� 3 Training Requirements�� 3 Residual Risks�� 3 Possible Adverse Events�� 3 Material Composition�� 3 Pneumatic Stealth-MidasTM LegendTM Motor�� 4 Components�� 4 Setting up the operating room�� 5 Power source requirements�� 5 Pneumatic connections�� 5 Pneumatic Stealth-Midas™ Legend™ System�� 6 Setting up the system�� 6 Connecting the motor�� 6 Activating the motor�� 6 Disassembling the system�� 7 Dissecting tools and attachments�� 8 Straight attachment assembly�� 8 Straight attachment disassembly�� 8 Angled attachment assembly�� 8 Angled attachment alignment��10 Angled attachment disassembly��10 Variable exposure straight and angled attachment��11 Navigable dissecting tools and attachments��11 Sterile sphere assembly��11 Navigation��12 Synergy spine software workflow��12 Instrument management: Adding Stealth-Midas to a procedure��13 Verifying the Stealth-Midas��14 Starting navigation��15 Projecting��17 Selecting tip��17 Changing views��18 Planning��18

Troubleshooting��19 System set-up check��20 Sterility��20 Pneumatic Stealth-Midas™ Legend™ system reprocessing instructions��20 Motor��20 PCU, regulator, and hose reprocessing instructions��21 Legend Attachments ��22 Return policy for devices exposed to TSE (transmissible spongiform encephalopathies)��23 Storage��23 Disposal��23 Planned maintenance��23 Limited warranty*��24 Symbols ��25

The Pneumatic Stealth-Midas™ Legend™ System

Glossary The following words and acronyms may be used in this guide. Dissecting tool

Disposable cutting tool that connects to Stealth-Midas motor

PCU

Pneumatic Control Unit

Tool list

List of navigable items in StealthStation software

PHYSICIAN NOTE: The physician must convey the indications, contraindications, warnings, and precautions given in this document to the patient.

General information Read and understand this manual before use of the using Pneumatic Stealth-Midas™ Legend™ System. The Pneumatic Stealth-Midas™ Legend™ System is designed for use by medical professionals familiar with powered surgical instrumentation. The surgeon is responsible for learning the proper techniques in the use of this system, as inappropriate use may potentially be harmful. It is strongly recommended that the surgeon and dedicated operating room personnel are knowledgeable with the use of this equipment system by being trained in Medtronic Midas Rex Hands-On Workshops or by one of the local authorized representatives.

Pneumatic Stealth-MidasTM LegendTM System description The Stealth-Midas is a powered drill that will remove soft tissue, hard tissue, bone, and biomaterials during surgical procedures. The permanently attached tracker will allow for intraoperative navigation of spinal procedures using the StealthStation.

Pneumatic motors Pneumatic motors provide power to operate disposable surgical dissecting tools. These motors are designed to interface with a series of attachments and surgical dissecting tools using a standard quick-connect locking mechanism.

Attachments Attachments are designed to align the surgical tools with the motor to provide support and stability during various surgical procedures. Attachment options, of various lengths, include regular (straight and angled) and variable exposure (straight and angled).

Surgical dissecting tools Surgical dissecting tools are designed and intended to resect, drill, or saw soft and hard tissue, bone, biomaterial, and metal during various surgical procedures.

System accessories System accessories enable the Pneumatic Stealth-Midas™ Legend™ System to carry out the system's intended use. Accessories include the motor wrench, cleaning brushes, instrument trays, PCU, lubricant/diffuser, pneumatic hoses, and tool rack. All of these are considered medical devices except for the tool rack.

Indications for use The Pneumatic Stealth-Midas™ Legend™ System is indicated for the drilling, burring, and removal of hard tissue and bone in spinal surgical procedures. Computer‑assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use 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 a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.

Target patient population Candidates for surgical applications stated in the Indications for use.

Intended use The Pneumatic Stealth-Midas™ Legend™ System is intended to be used to perform the task of removing hard tissue and bone through intraoperative navigation in spinal procedures with the Medtronic Stealth System.

Clinical benefits Clinical Benefits of the Pneumatic Stealth-Midas™ Legend™ System include real-time visualization of the instrument tip relative to patient anatomy with clinically acceptable accuracy, sufficient power to cut bone and biomaterials, ergonomic grip that allows precise control, sensory feedback while cutting, optimized visibility and maneuverability in the surgical site, the ability to adjust/configure the system efficiently, and a portfolio of attachments and tools that meet different surgical needs.

Contraindications None

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The Pneumatic Stealth-Midas™ Legend™ System

Warnings W1 W2 W3 W4 W5 W6 W7 W8 W9 W10 W11 W12 W13 W14 W15 W16 W17 W18 W19 W20 W21 W22 W23 W24 W25 W26 W27 W28 W29 W30 W31 W32 W33 W34 W35 W36 W37 W38 W39 W40 W41 W42 W43 W44 W45 W46 W47 W48 W49 W50 W51

2

The Stealth-Midas™ Legend™ System and its associated applications should be used only as an adjunct for surgical guidance. It is not a replacement for the surgeon’s knowledge, expertise, or judgment. Operate the system only after appropriate anatomical landmarks identified and the intended surgical site has been confirmed. Refer to the Medtronic Stealth System Instructions for Use (IFU) for instructions to complete these guidelines. Operate the system only after the attachment is in the locked position. Do not apply force when verifying dissecting tools. The user must be familiar with the IFU, its precautions, procedures, and safety issues. The system and its associate accessories should be used only by qualified medical professionals who are thoroughly trained and experienced in performing surgery with Medtronic powered surgery systems. Always inspect the device before and after use for any damage. If damage is observed, do not use device. During navigation, and after decompression and/or distraction, frequently confirm navigational accuracy by touching the tip of the Stealth-Midas on known anatomical points and comparing the position of the Stealth-Midas tip in the image with its physical location. Heavy side loads and/or long operating periods may cause the device to overheat. Always secure the secondary lock to eliminate motion between the dissecting tool and the tracker, which could impact navigation accuracy. Do not verify the motor for navigation with the motor running to prevent device damage or deposit metal shavings on the surgical site. Do not use excessive force to pry or push bone with the attachment or dissecting tool during surgery. Use only dissecting tools specifically designed for use with this drill system. Match the nomenclature and color code on the dissecting tool packaging to the same nomenclature and color code on the Attachment. Confirm that the dissecting tool package label indicates Stealth-Midas ( ) if navigation is required. Do not use the reusable devices before proper cleaning and sterilization. The Stealth-Midas™ Legend™ motor is a precision surgical instrument. With precision instruments, excessive force, beyond the design strength of the instruments, can be caused by even simple manual overloading. Carefully inspect tool both prior to and following each use for signs of excessive wear, fragmentation, eccentricities or other defects. Replace any suspicious dissecting tools with a new one prior to use. If system navigation seems inaccurate and recommended steps to restore accuracy are not successful, abort use of the system. Always re-verify the motor in the software when changing dissecting tools, attachments, or attachment orientation. Do not operate the motor in the presence of Magnetic Resonance Imaging devices. Do not use any parts other than Medtronic devices unless as noted, as damage or substandard performance could result. Refer to the Midas Rex™ Legend™ Pneumatic High-Speed System IFU and applicable Medtronic Stealth System manuals for additional instructions, warnings, and cautions. Use adequate irrigation during dissection to prevent thermal necrosis. Do not use an overheated device, as it may cause thermal injury to the patient or user. Never place an overheated motor on the patient or draping during the surgery. Sterilize and dry reusable device before storing. After each procedure, properly clean and sterilize all reusable devices. All service must be performed by Medtronic qualified personnel only. Do not attempt to remove a dissecting tool or attachment while the motor is running to prevent laceration of user and/or cross-contamination through a compromised glove. Do not immerse the device, except when recommended by the cleaning instructions in this IFU. Do not use the system if the motor continues to run after releasing the foot pedal. Do not place the device on the patient or in an unsecured location during surgery. Do not use an attachment and dissecting tool combination that results in tool flail or excessive vibration. Do not use the reusable device immediately after steam sterilization. Allow an adequate cooling period after steam sterilization. When using variable exposure attachments, surgeons should become familiar with the performance of dissecting tools before use and should explore the effect of various levels of tool exposure on tool stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure. Failure to follow prescribed maintenance schedule on motors and attachments may result in device(s) detaching and falling from the motor or attachment which may cause patient injury. To avoid this, motors and attachments should be serviced periodically at intervals recommended by Medtronic. Do no load more than one motor inside the instrument tray per sterilization cycle. The system devices must be cleanded separate from the instrument trays. Do not load system devices into instrument tray until the devices are clean. Failure to properly secure lubricant/diffuser cartridge may cause injury to patient, user, and/or operating room staff. Do not use a motor that is leaking lubricant. Do not pinch, kink, obstruct, cut, tear, or step on the motor/exhaust hose. This may cause the hose to burst, potentially injuring the patient or user. Tool flutes are sharp and may perforate surgical gloves. Keep the cutting area of the tool away from fingers and loose clothing to prevent laceration of user and cross-contamination through compromised glove. A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease pressure supplied to the motor to prevent vibration. If vibration persists, change to a different tool size or geometry to prevent unintended tissue damage. Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause patient hearing damage. Dissecting tools are for single-use only. Do not attempt to sterilize them. The dissecting tools are packed sterile and not intended for repeat use. To prevent contamination, use only once. Excessive pressure applied to tool may cause tool fracture. Should a tool fracture in use, exercise extreme care to ensure all the fragments of the tool are removed from the patient. Unremoved tool fragments may cause tissue damage to the patient. Do not use a dissecting tool if its packaging is damaged or opened outside the sterile field. Sterility is compromised if packaging is opened or damaged. Do not use dull tools. Use of dull tools can reduce cutting effectiveness and can cause the motor temperature to increase. Use of a dull tool may lead to heat at the cutting site. Exposure of tool packaging to ambient light for extended periods of time may cause damage to packaging. The system user should ensure sensitive anatomy is protected during drilling and use of the system. Failure to do so could cause injury to the patient. Do not sterilize and supply for surgical use any device that is not visibly clean and free of particulates. If particulates are present, repeat reprocessing, starting with the Preparation for Cleaning step.

The Pneumatic Stealth-Midas™ Legend™ System W52 Devices cannot be sterilized to an adequate Sterility Assurance Level (SAL) without prior cleaning. W53 Discontinue use of device if visualization to the surgical site is lost.

Precautions P1 P2 P3 P4 P5 P6 P7 P8 P9 P10 P11 P12 P13 P14 P15 P16 P17 P18 P19 P20 P21 P22 P23 P24 P25 P26 P27

The tracker is permanently affixed to the Stealth-Midas motor and should not be removed at any time. Remove navigation spheres from tracker and discard prior to cleaning and sterilization. The use of a washer-disinfector for cleaning may cause a degradation in performance. Do not use low-temperature hydrogen peroxide gas plasma sterilization due to the lumen internal diameter and length restrictions. Do not use low-temperature liquid peracetic acid sterilization due to immersion procedure. Do not use chlorine-based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite, sodium hydroxide, formic acid, or solutions containing glutaraldehyde. Remove and discard accessories following local regulations for disposal of contaminated materials. Do not use ultrasonic cleaners for system devices. Do not soak or submerge system devices. Use only nylon cleaning brushes. Non-nylon cleaning brushes leave residue that may prevent the tool from being secured properly in the motor. Do not expose these devices to sterilization temperatures greater than 137°C (279°F). Exposure to temperatures greater than 137°C (279°F) may impact the performance of the device and also the efficacy of the sterilization cycle. Because of the variability in cleaning efficiencies and sterilizer operating parameters, all given parameters (temperature, time, etcetera) should be validated by persons who have training and expertise in sterilization processes. Deviation from the recommended sterilization processes is at the risk of the user facility. Do not modify device; performance could be diminished. When not operating the motor, eliminate accidental foot control activation. Do not operate the system without eye protection. Use the instrument tray for sterilizing the reusable devices only. Do not use the instrument tray for cleaning or disinfection of the reusable devices. Tools with “L” identification are longer tools intended for light bone dissection. The increased tool head/stem configuration may affect dissection stability. It is recommended that devices should be cleaned as soon as possible, preferably within 30 minutes, following use to limit fixation of contaminants. Do not use a pneumatic motor without a lubricant/diffuser or oiler cartridge installed. Do not use a lubricant/diffuser or oiler cartridge for more than one hour of drill time. Do not reuse or attempt to refill a lubricant/diffuser or oiler cartridge. It is a single-use product. Do not use a lubricant/diffuser or oiler cartridge if it appears to be damaged, or if the inner foil seal is punctured. Do not carry PCU by the N2 DISS pressure hose. Do not disassemble equipment before gas pressure is released from PCU and associated hoses. Do not use the PCU to operate systems other than the Midas Rex™ and TRITON™ pneumatic systems. Ensure the adapter is fully threaded onto the regulator hose and that the adapter is fully threaded/connected to the corresponding wall outlet before operating the pneumatic system.

Training Requirements This device is intended for use by physicians, or appropriate staff , trained in the procedures described in the indications for use.

Residual Risks Residual risks related to the use of the Medtronic Pneumatic Stealth-Midas™ Legend™ System are: General surgical complications, Thermal injury, Tissue or bone damage, Blood loss, Nervous system injury, Cerebrospinal fluid leakage, Infection, Hearing damage, and Death.

Possible Adverse Events In the event that a serious incident has occurred related to device use, immediately report the event to Medtronic and the competent authorities.

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.

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The Pneumatic Stealth-Midas™ Legend™ System

Pneumatic Stealth-MidasTM LegendTM Motor Components The Pneumatic Stealth-MidasTM LegendTM motor (Figure 1) is a high-speed, high-torque motor used to dissect bone. Pneumatic Stealth-Midas

1

1. Hose

4.

Collet

2. Tracker

5.

Foot switch connection

3. Pneumatic motor

4

The Pneumatic Stealth-Midas™ Legend™ System

Setting up the operating room Power source requirements Required Operating (Dynamic) Pressure

Nominal Operating (Dynamic) Pressure

Approximate Flow Rate Required

Gas Type

80 psi to 120 psi

100 psi

12 cubic feet/minute

552 kPa to 827 kPa

690 kPa

340 liters/minute

Nitrogen or Dry-Filtered Compressed Air

CAUTION: Do not run the motor at an operating pressure above or below the required operating pressure range. Operating pressure below 552 kPa (80 psi) may not provide proper lubrication to the motor. Operating pressure above 827 kPa (120 psi) may damage or reduce the life of the motor.

Pneumatic connections 2

Gas connection options

1.

Regulator Hose (N2 DISS)

5.

Midas Rex™ safety valve regulator

2.

N2 DISS to Air DISS Adapter Gas Source

6.

DISS/WF4 Adapter

3.

N2 DISS to Male Schrader Adapter Gas Source

7.

Legend™ regulator

4.

Gas Source (N2 DISS)

CAUTION: If you are using the Midas Rex™ safety valve regulator instead of the Legend™ regulator, you must replace the in‑line oiler with the DISS/WF4 adapter before use. 5

The Pneumatic Stealth-Midas™ Legend™ System

Pneumatic Stealth-Midas™ Legend™ System Setting up the system Installing the Oiler Cartridge 1. 2. 3. 4.

Set the non-running (static) pressure to 552 kPa to 827 kPa (80 psi to 120 psi) at the gas source. Operating (dynamic) pressure may be adjusted later. Hold the lubricant/diffuser cartridge perpendicular to the housing (Figure 3-1), and press the cartridge’s circular fitting onto the housing’s circular receptacle (Figure 3-2), breaking the foil seal. Rotate the cartridge down until it clicks into place. Verify that the lock symbol on the cartridge is lined up with the notch on the housing (Figure 3-3).

Warnings: • Failure to properly secure the lubricant/diffuser cartridge may cause injury to user and/or operating room staff. • Do not attempt to remove the lubricant/diffuser cartridge while the system is pressurized. Cautions: • Do not use the motor without a lubricant/diffuser installed. • Do not use a lubricant/diffuser cartridge if it appears to be damaged, or if the inner foil seal is punctured. • Do not use a lubricant/diffuser cartridge for more than one hour of drill time. • Do not re-use a lubricant/diffuser cartridge. It is a single-use product. • Do not attempt to refill a used lubricant/diffuser cartridge. 3-1

Aligning the lubricant/diffuser cartridge with the housing

3-2

Pressing the cartridge onto the housing

3-3 Correctly installed lubricant/ diffuser cartridge

Connecting the motor Connect the motor hose to the motor port on top of the pneumatic control unit, by swinging the port cover to the side and pressing the end of the hose into the port (Figure 4-1). Warning: Do not pinch, kink, obstruct, cut, tear, or step on the motor/exhaust hose. This may cause the hose to burst, potentially injuring the patient or user. Note: The motor’s exhaust hose may have an oily film on the external surface from the pressure and/or temperature differentials following sterilization. Wipe the exhaust hose with a sterile cloth prior to use. If motor continues to have oil on the exhaust hose, return the motor to Medtronic for service. Prior to installation of a Legend attachment and dissecting tool, ensure that the arrows on the motor collet flats are aligned (Figure 4-2). If the arrows are not aligned, use the motor wrench to turn the collet flat closest to the motor case until its arrow is aligned with the arrow on the other collet flat.

Activating the motor 1. 2.

Activate the motor by pressing on the foot control pedal (Figure 5). Adjust operating pressure as needed at the compressed gas source until supply pressure gauge on pneumatic control unit reads within a range of 552 kPa to 827 kPa (80 – 120 psi) as required. Operating pressure (with motor running) will decrease slightly from the non-running (static) pressure setting when the motor is activated.

Note: To decrease pressure, turn down the in-house compressed gas source or turn the pressure handle on the regulator counter-clockwise. Push down on the pressure relief at the pneumatic control unit to exhaust pressure in the hoses. Then readjust pressure as needed.

6

The Pneumatic Stealth-Midas™ Legend™ System 4-1

Connecting the motor hose to the motor port

6

Motor port connection and pressure relief buttons

4-2

Aligning the collet flats

5

Foot control pedal

1.

Foot control pedal

2.

Air pressure gauge

3.

Control slide

Disassembling the system Depressurize the System 1. 2.

Turn off the compressed gas at the source. Press the pressure relief button on the pneumatic control unit, to release remaining gas (Figure 6).

Warning: Do not disassemble equipment before the gas is released from the control unit.

Disconnect hoses Release the motor hose from the control unit, by holding the hose firmly and pressing the motor port connection button (Figure 6). Discard the lubricant/diffuser Cartridge Remove the lubricant/diffuser cartridge from the housing and discard it. Caution: Do not re-use a lubricant/diffuser cartridge. It is a single-use product.

Remove the attachment and tools 1. 2. 1.

Motor port connection button

2.

Pressure relief button

Follow the applicable instructions in the Dissecting Tools and Attachments section of this manual to remove the attachment and tool from the motor. Discard used dissecting tools in an appropriate container.

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The Pneumatic Stealth-Midas™ Legend™ System

Dissecting tools and attachments Straight attachment assembly Caution: Match the nomenclature and color code on the tool packaging to the same nomenclature and color code on the attachment. Confirm that the dissecting tool packaging label has the Stealth-Midas logo ( ) on it if navigation is required. Notes: • An attachment will not seat on the motor if the arrows on the collet flats are not in alignment. • The motor will not run properly unless the attachment is in the locked position. • Smoke and/or excessive heat may be generated if the attachment is not in the fully locked position. This may result in thermal injury to the surgeon or staff. 1. 2. 3. 4. 5.

Slide a straight attachment over the motor collet aligning triangular arrows on the attachment and the motor case (Figure 7-1). An audible click, heard and perceptible by touch, confirms that the tool is fully seated. Insert the tool into the attachment with a slight rotational motion (Figure 7-2). An audible click, heard and perceptible to the touch, confirms that the tool is fully seated. Rotate the attachment in the direction indicated by arrow until the attachment alignment mark is directly in line with the locked symbol (Figure 7-3). You will hear two clicks as the attachment is rotated. Rotate the secondary lock to the locked position (Figure 7-4). Gently pull on the tool to ensure that it is locked into the handpiece.

Note: Tool should rotate freely. If not, unlock the assembly, re-seat the tool and re-lock the attachment. 7-1

Sliding the attachment over the motor collet

7-2

Inserting the dissecting tool into the attachment

7-3

Attachment in the locked position

7-4

Locking the secondary lock

Straight attachment disassembly 1. 2. 3. 4.

Hold the motor in palm of hand. Rotate the secondary lock to the unlocked position. Rotate the attachment to the unlocked position. Remove the dissecting tool from the attachment and discard the tool. For double lock attachments, push the sleeve on the attachment distally before rotating. Use thumb and index finger to lift the attachment off of the motor.

Angled attachment assembly Notes: • A dissecting tool may be installed and locked in the attachment before the angled attachment is installed onto the motor. • Angled and straight attachments with the same length, marking, and color band share the same dissecting tools. • The motor will not run properly unless the attachment is in the locked position. • Always secure the secondary lock when using angled attachments to eliminate motion between the dissecting tool and the tracker on the motor, which could impact navigation accuracy. • Confirm that the dissecting tool packaging label has the Stealth-Midas logo on it ( ) if navigation is required. • Smoke and/or excessive heat may be generated if attachment is not in the fully locked position. This may result in thermal injury to the surgeon or staff. 1. 2.

8

With the tool lock in the unlocked position, insert a dissecting tool into the angled attachment with a slight rotational motion (Figure 8-1). An audible click, heard and perceptible by touch, confirms that the tool is fully seated. Rotate the tool lock in the direction indicated by arrow until the tool lock alignment mark is directly in line with the locked symbol (Figure 8-2).

The Pneumatic Stealth-Midas™ Legend™ System 8-1

3. 4. 5. 6. 7.

8-3

Inserting the dissecting tool into the attachment

8-2

Tool lock in the locked position

Gently pull on the tool to ensure that it is locked into the handpiece. Slide the angled attachment over the motor collet aligning triangular arrows on the attachment and the motor case. An audible click, heard and perceptible by touch, confirms that the tool is fully seated. Rotate the attachment in the direction indicated by the arrow until attachment alignment mark is directly in line with the locked symbol. You will hear two clicks as the attachment is rotated. Verify that both the attachment to motor alignment mark and the tool lock alignment mark are directly in line with the locked symbol (Figure 8-3). Rotate the secondary lock to the locked position (Figure 8-4). This secondary lock is required to eliminate motion between the dissecting tool and the tracker on the motor, which could impact navigation accuracy. Toggle the attachment to confirm that the secondary lock is holding the tool securely. Motor alignment mark and tool lock alignment mark aligned with lock symbol

8-4

Secondary lock tightens attachment to motor

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The Pneumatic Stealth-Midas™ Legend™ System

Angled attachment alignment 1.

2.

9-1

Note that angled attachments can connect in two different orientations. To assemble the attachment so that the tracker faces to the left, insert the attachment facing up relative to the tracker. Rotate the attachment in the direction indicated by the arrow until attachment alignment mark is directly in line with the locked symbol. You will hear two clicks as the attachment is rotated. The tracker will now face to the left (Figure 9-1). To assemble the attachment so that the tracker faces to the right, insert the attachment facing down relative to the tracker. Rotate the attachment in the direction indicated by the arrow until attachment alignment mark is directly in line with the locked symbol. You will hear two clicks as the attachment is rotated. The tracker will now face to the right (Figure 9-2). Angled attachment in left orientation

Unlocked

3.

9-2

Locked

Angled attachment in right orientation

Unlocked

Locked

Note that the direction of the locked angled attachment will match the label on the tracker (Figure 9-3). This information will be used when selecting the appropriate navigation tool card. Angled attachment direction matches tracker label

9-3

Angled left

Angled right

Angled attachment disassembly 1. 2. 3.

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Rotate the Tool Lock to the unlocked position to remove the tool from the attachment. Rotate the secondary lock to the unlocked position. Rotate the attachment to the unlocked position and lift attachment off of the motor. For double lock attachments, push the sleeve on the attachment distally before rotating.

The Pneumatic Stealth-Midas™ Legend™ System

Variable exposure straight and angled attachment Warning: When using variable exposure attachments, surgeons should become familiar with the performance of dissecting tools before use and should explore the effect of various levels of tool exposure on tool stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure. Note: The variable exposure attachments can be distinguished from standard attachments by the dual color bands on the attachment. Match the color band on the attachment to the color code on the dissecting tool packaging.

10 Variable exposure attachment assembly

Assembly: 1. 2.

Assemble the variable exposure straight attachment using the Straight attachment Assembly instructions and the variable exposure angled attachments using the Angled attachment Assembly instructions. After assembly, use the tube adjustment ring to adjust the exposure of the dissecting tool (Figure 10). With the tool pointing away from you, turn the ring to the right to increase the length of the tube, thereby decreasing the exposure of the tool. Turn the ring to the left to decrease the length of the tube, thereby increasing the exposure of the tool.

Disassembly: Remove the variable exposure straight attachment using the Straight attachment Disassembly instructions and the variable exposure angled attachments using the Angled attachment Disassembly instructions.

Navigable dissecting tools and attachments Dissecting Tools Use only dissecting tools specifically designed for use with this drill system. Confirm that the dissecting tool packaging has the Stealth-Midas logo ( ) on it if navigation is required (Figure 11). 11

Midas tool label with Stealth-Midas logo

Attachments The Stealth-Midas is compatible with all Midas attachment types that correspond to a navigable tool: straight, angled, variable, or double-locking. Notes: • Variable attachments do not change the tip location of the dissecting tool. • Adjusting variable tube exposure will not be represented on navigation image.

Sterile sphere assembly Open sterile spheres package (P/N 8801085). One pack is a set of five. Place single-use sterile spheres on each of the tracker’s four posts. Press on each sterile sphere onto the stem until they “snap” into place. Ensure the sterile spheres are firmly seated on the posts, clean and dry before navigating.

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The Pneumatic Stealth-Midas™ Legend™ System

Navigation The following instructions for the Pneumatic Stealth-Midas™ Legend™ System, Figure 12, are in addition to the general navigation instructions found in the Synergy Spine & Trauma Pocket Guide and StealthStation™ System Manual. The user should consult the Synergy Spine & Trauma Pocket Guide and StealthStation™ System Manual for more detailed instruction on the StealthStation™ System.

Synergy spine software workflow Complete the following steps before navigating with the StealthStation S7. Refer to other Medtronic Stealth System manuals for use with other Medtronic Stealth Systems. 12

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Select Synergy Spine & Trauma.

Select Surgeon.

Select Procedure: Select the procedure type by selecting the imaging modality: Stealth-Midas uses Optical Tracking.

Set up Equipment: Ensure that all lines to essential equipment are green. If lines are dashed orange, check connections/cables.

Verify Instruments: Check that desired Stealth-Midas tool card is selected and matches physical hardware.

Acquire Scan: The system will remain on this screen until the O-arm system image acquisition step has been performed.

The Pneumatic Stealth-Midas™ Legend™ System

Instrument management: Adding Stealth-Midas to a procedure The Verify Instruments screen displays tool cards (Tool List) for the instruments configured for the procedure. The Tool List may be scrolled using the up or down arrows at the bottom of the list. Select the tool card that matches the attachment and dissecting tool that is connected to the motor. Note: Only one dissecting tool and attachment combination can be added to a procedure. Adding a new dissecting tool/attachment combination will automatically remove any other tool that had been selected. Caution: If a tool or attachment orientation is changed during a procedure, you must return to the Add or Remove Instruments screen to change the tool in the software. To add or remove instruments to the procedure, click [Add or Remove Instruments] to display the Add or Remove Instruments dialog (Figure 13). 13

Verify Instrument Screen: Select Add or Remove instruments if a different Stealth-Midas tool is desired

The Instruments Used in Procedure list displays prominently on the left. The Instruments Not Used in Procedure list displays on the right. Each list can be scrolled using the up or down arrows located at the bottom of each list. Use the search box located at the top of the Instruments Not Used in Procedure list to search for instruments without scrolling. Click [Search] and enter text for the instrument desired using the virtual keyboard onscreen or the system keyboard. The list is updated as text is entered or removed from the search box. Click [Done] to return to the Verify Instruments task. To add instruments to the Instruments Not Used in Procedure list, click [Add/Remove at this Site] to open the Admin panel to the Instruments tab (Figure 14). 14

Add or Remove Instrument Dialog: If desired instrument is not listed, it can be added by selecting Add/Remove at this Site

13

The Pneumatic Stealth-Midas™ Legend™ System Add or remove instruments used at the site from the Instruments tab. Then click [Done] to return to the Add or Remove Instruments dialog (Figure 15). 15

Add or Remove Instrument from this site: Press done to return to Verify Instruments screen

Verifying the Stealth-Midas The Verify Instruments screen (Figure 13) displays the tool card for the instruments selected for the procedure. Each tool card indicates whether those instruments are within the camera’s tracking view (main part of card is green) and whether it is verified (bottom part of the card). Warnings: • Physically inspect instruments for any defects. Never attempt to use a damaged instrument. • Always verify an instrument before use. • Always re-verify an instrument if you have changed tool or changed attachment orientations. • Do not apply force when verifying dissecting tool. Confirm that the tool card selected matches the physical set-up of the Stealth-Midas (Figure 16). 16

14

Confirm that the tool card selected matches the Stealth-Midas hardware

The Pneumatic Stealth-Midas™ Legend™ System You can verify instruments either now or later at the Navigate task. To verify an instrument: 1. Confirm that the correct reference frame and Stealth-Midas™ tool cards are pictured in the Verify Instruments screen. 2. Click [Camera] and confirm that both the Stealth-Midas instrument and the reference frame are visible in the Tracking View. 3. Insert the tip of the tool into the bottom of the divot in the reference frame (Figure 17). Keep the instrument as perpendicular to the divot as possible. 4. Hold the instrument steady for 2 seconds. 5. When the instrument is verified, the system makes a positive sound (chime), the bottom of the instrument’s tool card turns green, and changes to Verified status. When an instrument verification fails, the system makes a negative sound (bonk). 6. Click the right arrow to advance to the next task. 17

Verify Instrument Screen: Stealth-Midas is being inserted into reference frame divot

Starting navigation Warning: Frequently confirm navigation accuracy and system responsiveness during live navigation. Use the Stealth-Midas while not rotating to touch several bony anatomy landmarks and confirm that the locations identified on the images match the locations touched on the patient. If accuracy degrades, re-register the patient. For O-arm and 3D procedures, re-acquire the exam and re-register the patient. Caution: Ensure the Reference Frame is properly secured to anatomy. Neglecting to verify that the Reference Frame is secured could result in navigational inaccuracy if the hardware moves in relation to the anatomy after registration is complete. The Stealth-Midas with tool and attachment selected for the procedure is verified and automatically tracked when placed in the camera’s field of view. If you have not already verified the Stealth-Midas, do so now by holding its tip in the reference frame divot. During navigation, the software updates the 2D and 3D views in real time to reflect changes in the position of the Stealth-Midas’ tip on the anatomy. When navigation is active, the crosshairs display green. When navigation is frozen, the crosshairs display red. Tracked instrument status indicators display in green at the bottom right corner of the image area. The names of instruments that are not tracked are displayed in red. To display the image modification buttons, click the Modify Images tab. Click the tab again to hide the buttons. Refer to the Synergy Spine & Trauma Pocket Guide for more details.

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