Stealth Autoguide System Manual Rev D

No part of this documentation may be reproduced in any form or by any means or used to make any derivative work (such as translation, transformation, or adaptation) without written permission from Medtronic Navigation, Inc. 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 without notice and without incorporating those changes to products already sold.

1.Introduction Intended use 5 Indications for use 5 Clinical benefits 5 Contraindications 5 Operating Principle 6 Description of the Stealth Autoguide™ System 7 Navigational accuracy 8 System installation 8 User profiles 8 Compatibility 8 Side effects 9 Potential complications 9 Material composition 9 Conventions 9 Warnings and precautions 9 Warnings 9 Precautions 11 Stealth Autoguide™ system details 12 Surgical Instruments 13 Scope of this manual 16 Related documents 16 Contact information 17 Telephone 17 Mailing address 17 Medtronic E.C. authorized representative 17 Australia 17 World Wide Web 18 E-mail 18

2.Product Description User interface 19 Autoguide Targeting Unit 19 Autoguide Control Unit 20

3.Operation and Frequently Used Functions Starting the system 31 Stopping the system 31 Moving the system 31 Manual mode 32 Automatic mode 33 Adjusting the speed of the Autoguide Targeting Unit’s movement 34 Preparing the system 35 Connecting the cables 35 Mounting the system 37 Draping the system and inserting the end-effector 42 Setting up the end effector 45 Gross-positioning and alignment 50 Detecting deviations 52 Performing surgical procedures 54 Stab incision biopsy 55 Stab Incision Biopsy using the Autoguide Stab Incision Drill Guide 56

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Stab Incision Biopsy using the Autoguide Blunt Drill Guide 61 Burr hole biopsy 65 sEEG bolt placement 72 sEEG bolt placement using the Autoguide Stab Incision Drill Guide 73 sEEG bolt placement using the Autoguide Blunt Drill Guide 80 Visualase™ bone anchor placement 86 Shutting down the system and removing equipment 94 Emergency shutdown 95 Equipment removal in case of emergency 95

4.Cleaning Instructions Non-sterilizable components 97 General procedure 97 Cleaning the Autoguide Targeting Unit, Autoguide Control Unit, Autoguide Strain Relief Box, and Autoguide Power and Network Unit 98 Cleaning the Autoguide Head Clamp Adapter and Autoguide Positioning Arm 98 Cleaning the Autoguide Targeting Unit Cable Set, the Autoguide Control Unit Cable, and the Autoguide Power and Network Unit Cable 99 Cleaning the power cord 99 Cleaning the Stealth Autoguide™ Cart 100 Sterilizable components 100

5.Troubleshooting General information on error notifications 105 Autoguide Control Unit error codes 106 No bootup: The Autoguide Control Unit does not start up correctly 110 No communication with the StealthStation™ system 111 No display on the Autoguide Control Unit, but the system is still responding 113 Autoguide Control Unit indicates that no reachability information can be shown 113 The system does not execute automatic motion 114 Autoguide Control Unit indicates that the surgical plan has changed 115 The system is not aligning with the active surgical plan 116 Troubleshooting mechanical components, cables, and drapes 118 Stealth Autoguide™ Tracker troubleshooting 118 Autoguide Guiding Joint and Guiding Insert troubleshooting 119 Autoguide Positioning Arm troubleshooting 120 Cable troubleshooting 120 Drape troubleshooting 121

6.Service Corrective maintenance 123 Recommended maintenance 123 Spare parts 124 Disposal 124

7.Specifications System classifications 125 U.S. Food and Drug Administration classification 125 Electromagnetic emissions and immunity declarations 126 Warranty 127 Technical data 127 Essential performance 127 Intended environment for use 128

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Cable specifications 128 Technical specifications 129

8.Symbols Explanation of symbols on package labeling 133

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1

Introduction

Intended use The Stealth Autoguide™ System is a positioning and guidance system intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments, based on a pre-operative plan and feedback from an imageguided navigation system with three-dimensional imaging software.

Indications for use The Stealth Autoguide™ System is a remotely-operated positioning and guidance system, indicated for any neurological condition in which the use of stereotactic surgery may be appropriate (for example, stereotactic biopsy, stereotactic EEG, laser tissue ablation, etc.).

Clinical benefits The Stealth Autoguide™ System provides robotically assisted trajectory alignment for Medtronic instrumentation used during navigated biopsies, placement of stereotactic EEG bolts, and placement of bone anchors for Visualase™ procedures. Potential clinical benefits are to facilitate navigated procedures including minimally invasive procedures. When compared to other aiming device solutions, navigated procedures performed with the Stealth Autoguide™ System potentially confer the following clinical benefits: •

Increase in accuracy of the procedure

•

Reduction in surgical or operating room time

Contraindications Medical conditions which contraindicate the use of a computer-assisted neurosurgery system and its associated applications include any medical conditions which may contraindicate the medical procedure itself.

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Introduction Operating Principle

Operating Principle The Stealth Autoguide™ System has the following operating principle, in order to support stab incision biopsies, burr hole biopsies, the placement of sEEG bolts for depth electrodes, and the placement of bone anchors for Visualase™ thermal laser ablation therapies. •

Provide a mechanical connection to the patient head clamp

•

Provide a tracker for continuous position tracking by a StealthStation™ System

•

Read navigation data from a StealthStation™ System

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Align to the active surgical plan defined on a StealthStation™ System

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Provide a working channel for guiding and using custom, procedure specific surgical instruments

•

Support the creation of a cranial access hole with the use of Midas Rex™ MR8™ or Midas Rex™ Legend™ Depth Stop Attachment and Tools

•

Support the insertion of a Medtronic Navigated Biopsy Needle in biopsy procedures

•

Support the use of Ad-Tech LSB-PWL-2.4 and Ad-Tech LSB-PWL-4 series bolt wrenches for placement of Ad-Tech sEEG bolts

•

Support the use of DIXI ACS-710 Long Bolt Driver for placement of DIXI sEEG bolts

•

Support the use of PMT 2103-142 and 2013-143 sEEG Anchor Bolt Driver for placement of PMT sEEG bolts

•

Support the placement of Visualase™ Bone Anchors in Visualase™ procedures

Please keep in mind that establishing a connection between the Stealth Autoguide™ System and the StealthStation™ System is considered as configuring a system, per IEC60601-1.

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Introduction Description of the Stealth Autoguide™ System

Description of the Stealth Autoguide™ System The Stealth Autoguide™ System consists of a surgical trajectory platform and procedural-specific accessories. The products work together to create a complete procedural solution for trajectory alignment. The Autoguide Targeting Unit mounts near the patient’s head on the Autoguide Positioning Arm, which attaches to a standard patient head clamp via the Autoguide Head Clamp Adapter. The Autoguide Targeting Unit provides trajectory alignment for surgical instruments when it is within reach of the active surgical plan. The Autoguide Control Unit is the primary user interface for the system. The Autoguide Control Unit allows users to control motion of the Autoguide Targeting Unit, including manual positioning or automatic alignment to the active surgical plan, using navigation data received from the StealthStation™ System. The Autoguide Power and Network Unit and the Autoguide Strain Relief box provide the connection to the StealthStation™ system and to power. Figure 1: Stealth Autoguide™ System components

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Core system: For details refer to “Stealth Autoguide™ system details” on page 12.

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Autoguide Control Unit

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Autoguide Targeting Unit

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Autoguide Strain Relief Box

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Autoguide Power and Network Unit

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Stealth Autoguide™ Cart: Cart to store the parts of the Stealth Autoguide™ System.

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Surgical Instruments: For details refer to “Surgical Instruments” on page 13.

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Autoguide Sterile Drapes (not shown)

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Introduction Navigational accuracy

Navigational accuracy Under representative worst-case configuration, the Stealth Autoguide™ System used in conjunction with the StealthStation™ System with StealthStation™ Cranial software has demonstrated performance in 3D positional accuracy with a mean error ≤2.0 mm and in trajectory angle accuracy with a mean error ≤2.0 degrees. The positional error is defined as the Euclidean distance from target to instrument tip at final point of insertion. The trajectory angle error is the angle between the planned surgical trajectory and trajectory of the neurosurgical instrument at final point of insertion. Depending on the surgical procedure and the particular neurosurgical instruments used, the resulting navigational accuracy may be negatively impacted. This performance was determined using an anatomically representative phantom and utilizing a subset of system components and features that represent the worst-case combination of all potential system components in a clinically relevant workflow. The test configuration included CT images with slice spacing and thickness of 1.25 mm and T2-weighted MR images with slice spacing and thickness of 1.0 mm.

System installation The Stealth Autoguide™ System is installed by qualified Medtronic personnel only. If you have any questions about your system installation, contact Medtronic Navigation.

User profiles The intended user profile for the Stealth Autoguide™ System is operating room staff during the procedure (including surgeons, nurses, and clinical support specialists) and the sterile processing department personnel after the procedure. The users should be familiar with sterile workflows and usage of neurosurgical navigation equipment. The Stealth Autoguide™ System should be used only by qualified medical professionals who are thoroughly trained in use of the system. The intended patient population for the system is patients for whom stereotactic image guided surgery is appropriate.

Compatibility The Stealth Autoguide™ System is compatible with StealthStation™ S7™ and i7™ Systems running Cranial software version 3.1.2 or later and with StealthStation™ S8 Systems running Cranial software version 1.2.0 or later. For draping, the Stealth Autoguide™ System is compatible with the Autoguide Targeting Unit Sterile Drape (31304) and the Autoguide Control Unit Sterile Drape (29694). (Drapes are orderable using part number 9736245.) For sterilization and storage of the Stealth Autoguide™ reusable devices, use the Stealth Autoguide™ sterilization container (31814, 9736377, or 9736382). The sterilization container’s inner tray includes graphical outlines of the devices and corresponding part numbers.

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Introduction Side effects

Side effects The Stealth Autoguide™ System is an auxiliary surgical tool and does not independently produce any side effects. When used in conjunction with a Medtronic computer-assisted surgery system and its associated applications and navigated instruments for surgical procedures, the associated side effects are the same as those for the procedure itself.

Potential complications Potential complications related to use of the Stealth Autoguide™ System are the same as the potential complications for the procedures in which the system is used. The potential complications identified by Medtronic include, but are not limited to: General surgical complications, pain, infection, edema, biological reaction, electric shock, insufficient treatment, tissue or bone damage, vision impairment, extracranial or intracranial bleeding, cerebrospinal fluid leakage or fistula, brain or nerve damage, permanent or transient neurological deficit, paralysis, ischemic stroke (cerebral infarction), seizure, death

Material composition Material contained in product that can cause an allergic reaction: Nickel Warning: Use of this product can expose you to chemicals which are known to the State of California to cause cancer and/or birth defects or other reproductive harm. For more information, go to www.P65.Warnings.ca.gov. Additional materials of concern information such as REACH, CA Prop 65, or other product stewardship programs, go to www.medtronic.com/productstewardship.

Conventions This document employs the following conventions: •

Warnings are preceded by the word Warning. Failure to observe a warning may result in physical injury to the patient or operator. Pay special attention to these items.

•

Precautions are preceded by the word Caution. Failure to observe a precaution could result in damaged equipment, forfeited time or effort, or the need to abort use of the system.

Warnings and precautions Warnings Warning: The system may only be used by medical professionals.

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Introduction Warnings and precautions Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Warning: The power cord may not be extended by an extension cord since this increases the resistance of the protective earth and may result in electric shock. For the U.S.A. and other countries with dedicated medical grade power outlets, connection of the system is only allowed to a power outlet that provides a protective earth connection marked as “MEDICAL GRADE” or “HOSPITAL GRADE”. Warning: Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Warning: To avoid the risk of electrical shock, this equipment must only be connected to the supply mains with protective earth. Warning: Be aware of risks when using HF (high frequency) electrosurgery devices, such as monopolar or bipolar needles or forceps, together with the system. Hazardous voltage may be induced to the system. Risk of electrical shock or thermal injuries. Warning: Do not use HF (high frequency) electrosurgery devices, such as monopolar or bipolar needles or forceps, with maximum output voltages higher than 6 kV (peak-to-peak) together with the system. Hazardous voltage may be induced to the system. Risk of electrical arcs, electrical shocks, or thermal injuries. Warning: Avoid the following situations because they may compromise the integrity and efficacy of the Autoguide Sterile Drapes: • Rough handling, such as extreme pull and push forces or binding with moving parts • Touching unsterile surfaces with the drape • Close proximity of sharp instruments to the drape Warning: System status information may not be available on the Autoguide Control Unit due to a display failure. In this case, consult the StealthStation™ system display for current trajectory alignment information and the illuminated symbols on the Autoguide Targeting Unit to understand if any system error exists. Failure to follow these instructions may result in a risk of patient injury or a compromised surgical procedure. Warning: The use of instrumentation, interfaces, and sterile drapes other than stated compatible instruments, interfacing devices, and sterile drapes may lead to loss of accuracy, patient injury, or both. Warning: The use of system components beyond their useful life may lead to patient injury. Warning: The repair or modification of the system components or surgical instruments by anyone other than qualified service personnel may compromise the product’s ability to perform effectively and void the equipment warranty. Warning: Reusable devices are designed for re-use and are supplied in non-sterile condition. Clean and sterilize devices before every use in accordance with specified instructions.

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Introduction Warnings and precautions Warning: Connecting the system to non-approved IT networks and other equipment can result in previously unidentified risks to patients, operators, or third parties. The system must only be connected to a StealthStation™ system. Log files within the system will be maintained to verify proper setup. The responsibility for the identification, analysis, evaluation, and control of risks associated with connecting the system to a non-approved IT network resides with the individuals performing the connection. Warning: Changes to the IT network can introduce new risks to the product that require additional analysis. These changes encompass changes in network configuration, connection of additional items, disconnection of items, update of equipment, or upgrade of equipment. Log files within the system will be maintained to verify proper setup. Individuals implementing changes on the IT network are responsible for the identification, analysis, evaluation, and control of risks associated with the changes.

Precautions Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. Caution: Exceeding the maximum length of any cables may impact the electromagnetic performance and compliance (immunity or emission) of the system. Caution: The network connection to the StealthStation™ system must only be established directly, without use of any hub, switch, router, or equivalent device, to avoid any impairment of performance. Caution: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Stealth Autoguide™ system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

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Introduction Stealth Autoguide™ system details

Stealth Autoguide™ system details This section introduces the core system and its components with their main functions. Figure 2: The core system and its components

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1

25650 Autoguide Targeting Unit: Receives commands and power from the Autoguide Control Unit and moves to establish a fixed trajectory for surgical instruments. The Autoguide Targeting Unit is composed of two modules: the upper module angulates the surgical instruments carried by the end effector, and the lower module positions them. The Autoguide Targeting Unit operates while covered by the Autoguide Targeting Unit Sterile Drape. Note: The end effector is a device at the end of the Autoguide Targeting Unit that interacts with the environment. The guiding joints, guiding inserts, and the Stealth Autoguide™ Tracker form the end effector. The end effector is a Type CF rated patient applied part.

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28248 Stealth Autoguide™ Tracker: Holds and guides surgical instruments. The user can secure instruments in the tracker with a knob screw. The tracker is connected to the Autoguide Targeting Unit by the Autoguide Guiding Inserts and the Autoguide Guiding Joints. The tracker is sterilizable. The StealthStation™ system infrared camera tracks the position and orientation of the Stealth Autoguide™ Tracker by detecting the spatial location of the passive optical spheres mounted to the tracker.

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27584 (9736191) Autoguide Guiding Joint: Two Autoguide Guiding Joints connect the Autoguide Targeting Unit to the Autoguide Upper Guiding Insert and Autoguide Lower Guiding Insert. The Autoguide Guiding Joints transmit the movement of the Autoguide Targeting Unit modules to the Autoguide Guiding Inserts and the Stealth Autoguide™ Tracker, through the Autoguide Targeting Unit Sterile Drape. The Autoguide Guiding Joints are sterilizable.

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27586 (30463) Autoguide Upper Guiding Insert: Connects an Autoguide Guiding Joint to the Stealth Autoguide™ Tracker. The Autoguide Upper Guiding Insert is sterilizable.

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28249 (30463) Autoguide Lower Guiding Insert: Connects an Autoguide Guiding Joint to the Stealth Autoguide™ Tracker. Includes a knob screw for fixation of the Stealth Autoguide™ Tracker. The Autoguide Lower Guiding Insert is sterilizable.

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29480 Autoguide Positioning Arm: An articulating arm for flexible pre-positioning of the Autoguide Targeting Unit. The Autoguide Positioning Arm can be locked in a specific position by the user. The arm has two starburst interfaces. The large starburst interface connects with the Autoguide Head Clamp Adapter and the small starburst interface connects to the Autoguide Targeting Unit.

Introduction Stealth Autoguide™ system details

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29439 Autoguide Head Clamp Adapter: Interface between the patient head clamp and the Autoguide Positioning Arm that carries the Autoguide Targeting Unit. This component ensures the targeting system and the patient maintain consistent positioning relative to one another and provides a mechanical interface to mount equipment. The Autoguide Head Clamp Adapter includes a coupling that contains 2 additional starburst interfaces thus allowing a total of 4 mounting point options for the Autoguide Positioning Arm and the Vertek™ II Arm.

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29193 Autoguide Strain Relief Box: Mounted to the side-rail of the operating room table. Distributes power and data to system components and prevents cables from pulling on the Autoguide Control Unit and Autoguide Targeting Unit.

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28080 Autoguide Control Unit: The primary user interface for the system. The Autoguide Control Unit allows users to control motion of the Autoguide Targeting Unit to automatically align to the active surgical plan or to manually position the system to any point within the range of motion. The Autoguide Control Unit cable connects the Autoguide Control Unit to the Autoguide Strain Relief Box. The Autoguide Control Unit operates while covered by the Autoguide Control Unit Sterile Drape.

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28635 Autoguide Power and Network Unit: Provides power for the Autoguide Control Unit and Autoguide Targeting Unit. Connects and provides a data interface to the StealthStation™ system.

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29440 Autoguide Targeting Unit Cable Set: Provides power and control for the Autoguide Targeting Unit. The cable set consists of two identical cables combined by a mechanical fixation piece. This mechanical fixation piece is mounted to a mechanical recess on the large starburst adapter of the Autoguide Positioning Arm to prevent cables from pulling on the Autoguide Targeting Unit.

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Autoguide Power and Network Cable: Cable between the Autoguide Strain Relief Box and the Autoguide Power and Network Unit.

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Power cord: Cable between the Autoguide Power and Network Unit and the wall outlet.

w

Network cable: Ethernet cable between the Autoguide Power and Network Unit and the Ethernet port on the StealthStation™ system.

Surgical Instruments This section introduces the surgical instruments that are compatible with the Stealth Autoguide™ system and their main functions. The surgical instruments are a set of drill guides, reducing tubes, and obturators that are inserted into the Stealth Autoguide™ Tracker and used to support drilling and guide various instrumentation needed to execute the surgical procedures. Each instrument is marked with the product number and the corresponding procedure for identification. •

“BIOPSY” - Surgical instruments to be used for biopsy (refer to items 1, 2, 3, 4, 5, and 11 in Figure 3).

•

“SEEG” - Surgical instruments to be used for placement of sEEG (stereo electroencephalography) bolts (refer to items 3, 4, 6, 7, 11, 14, and 15 in Figure 3). Note: sEEG instruments include either the Autoguide sEEG 2.4 mm Reducing Tube (28336) or the Autoguide sEEG 2.5 mm Reducing Tube (9736381), not both.

•

“VISUALASE” - Surgical instruments to be used for the placement of Visualase™ Bone Anchors (refer to items 8, 9, 10, 12, and 14 in Figure 3).

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Introduction Stealth Autoguide™ system details Figure 3: Surgical instruments

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1

28322 Autoguide Burr Hole Drill Guide is a tube with sharp teeth on its distal end. The drill guide is anchored to the skull through gentle hammering and provides guidance and stability to the Midas Rex™ Legend™ Depth Stop Attachment (ASDS01) while creating a cranial access hole. This drill guide is compatible with the Midas Rex™ MR8™ Depth Stop Twist Drill Burr Hole Biopsy Tool (MR8-DS1TD75) and the Legend™ Depth Stop Twist Drill 7.5 mm Burr Hole Biopsy Tool (DS1TD75).

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28334 Autoguide Burr Hole 2.2 mm Reducing Tube consists of a 2.2 mm inner-diameter reducing tube that can be introduced directly into the Stealth Autoguide™ Tracker to guide a 2.2 mm diameter Biopsy Needle during tissue harvesting. This reducing tube is compatible with the Medtronic Navigated Biopsy Needle.

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28340 Autoguide Stab Incision Obturator is a rod with a sharp point used to aid in the anchoring of the Autoguide Stab Incision Drill Guide (28326). The Obturator is inserted into the drill guide, introduced into the skin incision, and temporarily anchored onto the skull through gentle hammering. The obturator provides guidance for subsequent anchoring of the Autoguide Stab Incision Drill Guide. After the Autoguide Stab Incision Drill Guide has been adequately anchored to the skull, the Autoguide Stab Incision Obturator is removed.

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28326 Autoguide Stab Incision Drill Guide is a tube with sharp teeth on its distal end. The drill guide is anchored to the skull through gentle hammering and provides guidance and stability to the Midas Rex™ Depth Stop Attachment (MR8-ASDS01 or ASDS01) while creating a cranial access hole. This drill guide is compatible with the Autoguide sEEG 2.5 mm Reducing Tube (9736381), Autoguide Stab Biopsy 2.2 mm Reducing Tube (28330), the Autoguide sEEG 2.4 mm Reducing Tube (28336), the Autoguide sEEG 4.0 mm Reducing Tube (28328), the Midas Rex™ MR8™ Depth Stop Twist Drill (MR8-DS1TD32), the Legend™ Depth Stop Twist Drill 3.2 mm Stab Biopsy Tool (DS1TD32), the Midas Rex™ MR8™ Depth Stop Twist 2.4 mm sEEG Bolt Placement Tool (MR8-DS1TD24), and the Legend™ Depth Stop Twist Drill 2.4 mm sEEG Bolt Placement Tool (DS1TD24).

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28330 Autoguide Stab Biopsy 2.2 mm Reducing Tube consists of a 2.2 mm inner-diameter reducing tube that can be introduced into the Autoguide Stab Incision Drill Guide (28326) to guide a 2.2 mm diameter Biopsy Needle during tissue harvesting. This reducing tube is compatible with the Medtronic Navigated Biopsy Needle.

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28336 Autoguide sEEG 2.4 mm Reducing Tube consists of a 2.4 mm inner-diameter reducing tube that can be introduced into the Autoguide Blunt Drill Guide (9736380) or Autoguide Stab Incision Drill Guide (28326) to guide a 2.4 mm diameter sEEG bolt driver during the placement of sEEG bolts. This reducing tube is compatible with the Ad-Tech LSB-PWL-2.4 series bolt drivers. (Ad-Tech bolt drivers are not provided by Medtronic.)

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28328 Autoguide sEEG 4.0 mm Reducing Tube consists of a 4.0 mm inner-diameter reducing tube that can be introduced into the Autoguide Blunt Drill Guide (9736380) or Autoguide Stab Incision Drill Guide (28326) to guide a 4.0 mm diameter sEEG bolt driver during the placement of sEEG bolts. This reducing tube is compatible with the PMT 4.0 mm bolt driver and the Ad-Tech LSB-PWL-4.0 series bolt drivers. (PMT and Ad-Tech bolt drivers are not provided by Medtronic.)

Introduction Stealth Autoguide™ system details

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28324 Autoguide Visualase™ Drill Guide is a tube with sharp teeth on its distal end. The drill guide is anchored to the skull through gentle hammering and provides guidance and stability to the Midas Rex™ Depth Stop Attachment (MR8-ASDS01 or ASDS01) while creating a cranial access hole. This drill guide is compatible with the Midas Rex™ MR8™ Depth Stop Twist Drill 3.2 mm Long Visualase™ Tool (MR8-DS1TD32L) and the Legend™ Depth Stop Twist Drill 3.2 mm Long Visualase™ Tool (DS1TD32L).

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28338 Autoguide Visualase™ Obturator is a rod with a sharp point used to aid in anchoring of the Autoguide Visualase™ Drill Guide (28324). The obturator is inserted into the drill guide, introduced into the skin incision, and temporarily anchored onto the skull through gentle hammering. The obturator provides guidance for subsequent anchoring of the Autoguide Visualase™ Drill Guide. After the Autoguide Visualase™ Drill Guide has been adequately anchored to the skull, the Autoguide Visualase™ Obturator is removed.

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28332 Autoguide Visualase™ 1.7 mm Reducing Tube consists of a 1.7 mm inner-diameter reducing tube that can be introduced directly into the Stealth Autoguide™ Tracker to guide the Visualase™ Alignment Rod during the placement of a Visualase™ Bone Anchor.

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27563 Autoguide Stab Incision Height Guide is inserted into the Stealth Autoguide™ Tracker and touches the head (skin) of the patient. The Autoguide Stab Incision Height Guide provides an offset between the Stealth Autoguide™ Tracker and the patient to ensure proper distance between the Autoguide Targeting Unit and the patient’s head for biopsy and sEEG procedures. The Autoguide Stab Incision Height Guide also provides the verification tip for the Stealth Autoguide™ Tracker.

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27565 Autoguide Visualase™ Height Guide is similar to the Autoguide Stab Incision Height Guide but is slightly longer to ensure that the bottom of the Stealth Autoguide™ Tracker is 50 mm above the scalp, so that the Visualase™ Bone Anchor fits under the Autoguide Targeting Unit. The Autoguide Visualase™ Height Guide also provides the verification tip for the Stealth Autoguide™ Tracker.

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31527 Autoguide Tapping Tube allows the obturator to remain securely in place while the user hammers the Autoguide Visualase™ Drill Guide (28324) and the Autoguide Stab Incision Drill Guide (28326).

w

9736381 Autoguide sEEG 2.5 mm Reducing Tube consists of a 2.5 mm inner-diameter reducing tube that can be introduced into either the Autoguide Stab Incision Drill Guide (28326) or the Autoguide Blunt Drill Guide (9736380) to guide a 2.5 mm diameter sEEG bolt driver during the placement of sEEG bolts. This reducing tube is compatible with the Ad-Tech LSB-PWL-2.4 series bolt drivers, DIXI ACS-710 Long Bolt Driver, and the PMT 2103-143 sEEG Anchor Bolt Driver. (Ad-Tech, DIXI, and PMT bolt drivers are not provided by Medtronic.)

e

9736380 Autoguide Blunt Drill Guide is a tube with a blunt distal end. The blunt drill guide can be floated above the incision or rested on patient bone or skin. This drill guide is compatible with the Autoguide sEEG 2.4 mm Reducing Tube (28336), Autoguide sEEG 2.5 mm Reducing Tube (9736381), Autoguide sEEG 4.0 mm Reducing Tube (28328), Midas Rex™ MR8™ Depth Stop Twist 2.4 mm sEEG Bolt Placement Tool (MR8-DS1TD24), and the Legend™ Depth Stop Twist Drill 2.4 mm sEEG Bolt Placement Tool (DS1TD24).

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Introduction Scope of this manual

Scope of this manual This manual contains all information for the user to set up, maintain, troubleshoot, and operate the Stealth Autoguide™ System.

Related documents For navigation software instructions, refer to the specific software’s instructions for use. For components that interface with the StealthStation™ system, such as instruments, patient reference frames, or intraoperative imaging systems, refer to the component’s instructions for use. For Visualase™ instructions, refer to the instructions for use that accompany the Visualase™ MRIGuided Laser Ablation System and its components. For Drill System instructions, refer to the instructions for use that accompany the drill system and the Midas Rex™ MR8™ or Midas Rex™ Legend™ Depth Stop Attachment and Tools. For cleaning and sterilization instructions of the surgical accessories provided with the Stealth Autoguide™ System, refer to the instructions for use (part number 9736152) that accompany the sterilization container. For cleaning of the Midas Rex™ MR8™ or Midas Rex™ Legend™ Depth Stop Attachment, refer to the instructions for use that accompany the product. For information about the Stealth Autoguide™ Cart, including cleaning instructions, refer to the cart manufacturer’s instructions for use. If issues arise related to those individual systems, refer also to the guidance found in the instructions for use provided by the systems’ manufacturer.

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Introduction Contact information

Contact information If a serious incident occurs in relation to the use of this system, 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.

Telephone Technical support worldwide

+1 720 890 3160

Technical support in the USA

+1 800 595 9709

General

+1 720 890 3200

Fax

+1 720 890 3500

Mailing address Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA

Medtronic E.C. authorized representative Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. +31 45 566 80 00

Australia Medtronic Australasia Pty Ltd 2 Alma Road Macquarie Park, NSW 2113 Australia Tel. 1800 668 670 (within Australia)

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Introduction Contact information

World Wide Web www.medtronic.com

E-mail E-mail product enhancement requests to: [email protected]

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2

Product Description

User interface Autoguide Targeting Unit Figure 4: Symbols on the Autoguide Targeting Unit

Depending on the status of the Autoguide Targeting Unit, the following symbols are illuminated:

1

HOME: Autoguide Targeting Unit in home position. The Autoguide Targeting Unit is in its center position for all axes of movement.

2

OUT OF REACH: Trajectory out of reach. No automatic alignment is possible.

3

ERROR OR WARNING: Error or warning during operation or on the device. Details for the warnings are shown on the display of the Autoguide Control Unit.

4

IN REACH: Trajectory in reach. Automatic alignment is possible.

5

ALIGNED: Trajectory aligned with the active surgical plan. Symbol flashes when a deviation of more than 1 mm from the active surgical plan is detected.

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