Medtronic 29631 Instructions for Use

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Stealth Autoguide™ System Manual

Read this manual completely before using this device.

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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.

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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

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

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system details 12

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 43

Setting up the end effector 46 Gross-positioning and alignment 52

Detecting deviations 54 Performing surgical procedures 56

Stab incision biopsy 56

Burr hole biopsy 63

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sEEG bolt placement 68 Visualase™ bone anchor placement 76

Shutting down the system and removing equipment 84

Emergency shutdown 85 Equipment removal in case of emergency 85

4.Cleaning Instructions

Non-sterilizable components 87

General procedure 87 Cleaning the Autoguide Targeting Unit, Autoguide Control Unit, Autoguide Strain Relief Box,

and Autoguide Power and Network Unit 88 Cleaning the Autoguide Head Clamp Adapter and Autoguide Positioning Arm 88 Cleaning the Autoguide Targeting Unit Cable Set, the Autoguide Control Unit Cable, and the

Autoguide Power and Network Unit Cable 89 Cleaning the power cord 89

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Cleaning the Stealth Autoguide

Cart 90

Sterilizable components 90

5.Troubleshooting

General information on error notifications 93 Autoguide Control Unit error codes 94 No bootup: The Autoguide Control Unit does not start up correctly 98 No communication with the StealthStation

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system 99

No display on the Autoguide Control Unit, but the system is still responding 101 Autoguide Control Unit indicates that no reachability information can be shown 101 The system does not execute automatic motion 102 Autoguide Control Unit indicates that the surgical plan has changed 103 The system is not aligning with the active surgical plan 104

Troubleshooting mechanical components, cables, and drapes 106

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Stealth Autoguide

Tracker troubleshooting 106 Autoguide Guiding Joint and Guiding Insert troubleshooting 107 Autoguide Positioning Arm troubleshooting 108 Cable troubleshooting 108 Drape troubleshooting 109

6.Service

Corrective maintenance 111 Recommended maintenance 111 Spare parts 112 Disposal 112

7.Specifications

System classifications 113

U.S. Food and Drug Administration classification 113

Electromagnetic emissions and immunity declarations 114 Warranty 115 Technical data 115

Essential performance 115

Intended environment for use 116 Cable specifications 116

Technical specifications 117

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8.Symbols

Explanation of symbols on package labeling 121

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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 including minimally invasive procedures. When compared to other aiming device solutions, navigated procedures performed with the Stealth Autoguide the following clinical benefits:

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procedures. Potential clinical benefits are to facilitate navigated

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System potentially confer

• 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

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

• Provide a mechanical connection to the patient head clamp

• Provide a tracker for continuous position tracking by a StealthStation

• Read navigation data from a StealthStation™ System

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

• 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

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

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thermal laser ablation therapies.

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System

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Legend™ Depth Stop

• Support the placement of Visualase

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Bone Anchors in Visualase™ procedures

Please keep in mind that establishing a connection between the Stealth Autoguide StealthStation

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System is considered as configuring a system, per IEC60601-1.

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System and the

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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 and the Autoguide Strain Relief box provide the connection to the StealthStation power.

Figure 1: Stealth Autoguide

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System. The Autoguide Power and Network Unit

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System components

Introduction

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system and to

1 Core system: For details refer to “Stealth Autoguide

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system details” on page 12.

2 Autoguide Control Unit 3 Autoguide Targeting Unit 4 Autoguide Strain Relief Box 5 Autoguide Power and Network Unit 6 Stealth Autoguide

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

7 Surgical Instruments: For details refer to “Surgical Instruments” on page 13. 8 Autoguide Sterile Drapes (not shown)

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Introduction

Navigational accuracy

Under representative worst-case configuration, the Stealth Autoguide™ System used in conjunction with the StealthStation 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

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System with StealthStation™ Cranial software has demonstrated

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 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 version 1.2.0 or later.

For draping, the Stealth Autoguide Drape (31304) and the Autoguide Control Unit Sterile Drape (29694).

For sterilization and storage of the Stealth Autoguide Autoguide outlines of the devices and corresponding part numbers.

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System should be used only by qualified medical professionals who are

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S8 Systems running Cranial software

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System is compatible with the Autoguide Targeting Unit Sterile

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sterilization container (31814). The sterilization container’s inner tray includes graphical

reusable devices, use the Stealth

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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

Introduction

Side effects

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.

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.

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.

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Introduction

Warnings and precautions

Warning:

Warning: Use of accessories, transducers, and cables other than those specified or provided by the

Warning: To avoid the risk of electrical shock, this equipment must only be connected to the supply

Warning: Be aware of risks when using HF (high frequency) electrosurgery devices, such as

Warning: Do not use HF (high frequency) electrosurgery devices, such as monopolar or bipolar

Warning: Avoid the following situations because they may compromise the integrity and efficacy of

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. 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”.

manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

mains with protective earth.

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.

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.

the Autoguide Sterile Drapes:

• Rough handling, such as extreme pull and push forces or binding with moving parts

• Touching unsterile surfaces with the drape

For the U.S.A. and other

• 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 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.

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 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.

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system. Log files within the system will be maintained to verify

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system display for current trajectory

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Precautions

Introduction

Warnings and precautions

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.

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

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 the performance of this equipment could result.

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system, including cables specified by the manufacturer. Otherwise, degradation of

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system must only be established directly,

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Introduction

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

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 form the end effector. The end effector is a Type CF rated patient applied part.

2 28248 Stealth Autoguide

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 the Stealth Autoguide mounted to the tracker.

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Tracker: Holds and guides surgical instruments. The user can

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Tracker by detecting the spatial location of the passive optical spheres

system infrared camera tracks the position and orientation of

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Tracker

3 27584 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 Unit Sterile Drape. The Autoguide Guiding Joints are sterilizable.

4 27586 Autoguide Upper Guiding Insert: Connects an Autoguide Guiding Joint to the Stealth

Autoguide

5 28249 Autoguide Lower Guiding Insert: Connects an Autoguide Guiding Joint to the Stealth

Autoguide Autoguide Lower Guiding Insert is sterilizable.

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Tracker. The Autoguide Upper Guiding Insert is sterilizable.

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Tracker. Includes a knob screw for fixation of the Stealth Autoguide™ Tracker. The

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Tracker, through the Autoguide Targeting

6 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.

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Introduction

Stealth Autoguide™ system details

7 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

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II Arm.

8 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.

9 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.

0 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

- 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.

= Autoguide Power and Network Cable: Cable between the Autoguide Strain Relief Box and the

Autoguide Power and Network Unit.

q 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

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 needed to execute the surgical procedures. Each instrument is marked with the product number and the corresponding procedure for identification.

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system.

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Tracker and used to support drilling and guide various instrumentation

system.

• “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, and 11 in Figure 3)

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

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Bone Anchors

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Introduction

Stealth Autoguide™ system details

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 Legend Biopsy Tool (DS1TD75).

Figure 3: Surgical instruments

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Depth Stop Twist Drill 7.5 mm Burr Hole

2 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

2.2 mm diameter Biopsy Needle during tissue harvesting. This reducing tube is compatible with the Medtronic Navigated Biopsy Needle.

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Tracker to guide a

3 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.

4 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™ Legend™ Depth Stop Attachment (ASDS01) while creating a cranial access hole. This drill guide is compatible with the 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 Legend (DS1TD32), and the Legend (DS1TD24).

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Depth Stop Twist Drill 2.4 mm sEEG Bolt Placement Tool

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Depth Stop Twist Drill 3.2 mm Stab Biopsy Tool

5 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.

6 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 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.)

7 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 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 Ad-Tech LSB-PWL-4.0 series bolt drivers. (Ad-Tech bolt drivers are not provided by Medtronic.)

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Introduction

Stealth Autoguide™ system details

8 28324 Autoguide Visualase

guide is anchored to the skull through gentle hammering and provides guidance and stability to the Midas Rex hole. This drill guide is compatible with the Legend Visualase

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Legend™ Depth Stop Attachment (ASDS01) while creating a cranial access

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Tool (DS1TD32L).

9 28338 Autoguide Visualase

of the Autoguide Visualase

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Drill Guide is a tube with sharp teeth on its distal end. The drill

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Depth Stop Twist Drill 3.2 mm Long

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Obturator is a rod with a sharp point used to aid in anchoring

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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 anchored to the skull, the Autoguide Visualase

0 28332 Autoguide Visualase

reducing tube that can be introduced directly into the Stealth Autoguide Visualase

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Drill Guide. After the Autoguide Visualase™ Drill Guide has been adequately

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1.7 mm Reducing Tube consists of a 1.7 mm inner-diameter

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Alignment Rod during the placement of a Visualase™ Bone Anchor.

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Obturator is removed.

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Tracker to guide the

- 27563 Autoguide Stab Incision Height Guide is inserted into the Stealth Autoguide

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

= 27565 Autoguide Visualase

Guide but is slightly longer to ensure that the bottom of the Stealth Autoguide 50 mm above the scalp, so that the Visualase Targeting Unit. The Autoguide Visualase Stealth Autoguide

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Tracker.

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Tracker.

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Height Guide is similar to the Autoguide Stab Incision Height

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Bone Anchor fits under the Autoguide

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Height Guide also provides the verification tip for the

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Tracker is

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Tracker

q 31527 Autoguide Tapping Tube allows the obturator to remain securely in place while the

user hammers the Autoguide Visualase

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Drill Guide (28324) and the Autoguide Stab Incision

Drill Guide (28326).

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Introduction

Scope of this manual

This manual contains all information for the user to set up, maintain, troubleshoot, and operate the Stealth Autoguide

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

Introduction

Contact information

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: dl.navsuggestions@medtronic.com

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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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Product Description

User interface

Autoguide Control Unit

Figure 5: Autoguide Control Unit displays and controls

The Autoguide Control Unit offers the following displays and controls:

1 Joystick to manually guide the Autoguide Targeting Unit 2 Power LED:

• OFF: system not powered

• WHITE: system powered but in stand-by mode

• GREEN: system turned on and running

• Blinking RED: major system fault

3 Display: For details refer to the sections in this chapter. 4 Power button symbol: The power button is near the symbol. 5 Enable button:

In Manual mode, enables angulation or positioning In Automatic mode, either section of the Enable button (angulation or

positioning ) initiates motion

6 Speed button: Normal speed or slow speed 7 Mode button: Automatic or Manual mode 8 Move button: Press a Move button and then the Enable button to

Move to Plan or Move to Home

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Product Description

User interface

Boot-up screen

During boot-up, the serial number, firmware versions, and IP configurations are shown for a few seconds.

Figure 6: Boot-up screen

Main operation screens

After successful initialization, the system enters the main operation mode and the Power LED turns green.

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Product Description

User interface

Figure 7: Symbols on the main operation screens

1 Homing state 2 Reachability information 3 Network connection 4 Speed level 5 Warning / Error 6 Operation mode

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Meaning of single symbols of the main operation screens

Homing state symbols

Autoguide Targeting Unit in home position

Autoguide Targeting Unit not in home position

Reachability information symbols

No reachability information available. This can have several causes:

• No connection to the StealthStation

• Tool not verified

• Currently not in the Navigation task on the StealthStation

• No surgical plan available

• Autoguide Targeting Unit not in home position after gross positioning

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system

Product Description

User interface

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system

flashing

Out of reach The system cannot reach the current plan. Automatic alignment is not possible.

In reach The system can reach the current plan. Automatic alignment is allowed.

Trajectory aligned and move to plan is complete

Deviation detected in Motion Monitoring Mode. Both symbols are alternating flashing. For details, refer to “Flashing symbols during

operation” on page 25.

Tool or reference frame is not visible and navigation not possible. Additionally, the warning symbol lights up.

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Product Description

User interface

Network connection symbols

No network connection is available. For example, the network cable is not connected.

Network connection established with peripheral device, but no connection to the StealthStation

Communication with the StealthStation

Speed level symbols

Low speed

Normal speed

Warning / Error symbols

Warning An exception has occurred. The reason for the warning is indicated by a dedicated

symbol above the warning symbol. For more details, refer to “Warning screens” on page 26.

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system.

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system is successfully established.

Warning indicator for emergency behavior mode. For more details, refer to “Warning screens” on page 26.

Page 27

Operation mode symbols

Automatic mode This mode allows the user to perform either an automatic movement to the home

position or an automatic movement to align to the current plan.

Manual mode This mode allows manual joystick movements.

Motion Monitoring mode This mode does not allow movements and is automatically entered upon a

successful alignment to plan, after 5 seconds of idle time. Within this 5-second period, the user can refine the alignment using manual or automatic mode. Additional selection of another motion mode (either Automatic mode or Manual mode) is required to remove the system from this mode.

EMC Silent mode In this mode, power to the Autoguide Targeting Unit is turned off, which minimizes

emissions in the surgical area by maintaining power only to the Autoguide Control Unit.

Product Description

User interface

Flashing symbols during operation

During system operation, the following flashing symbols indicate special operation states:

Movement to the home position is active (activated by the Move to Home button

This symbol turns to and the system emits an audio signal when movement is finished.

Movement to plan is active (activated by the Move to Plan button ). This symbol turns to and the system emits an audio signal when movement is

finished.

The system is about to move to the plan but the Stealth Autoguide

™

Tracker or reference frame is not visible. The system remains in a waiting state until visibility is restored or the user releases the Move to Plan button .

Deviation detected in Motion Monitoring Mode When a deviation to the active surgical plan that is 1 mm or greater is detected, the

Deviation symbol flashes, alternating between the symbols and . The Aligned symbol on the Autoguide Targeting Unit flashes accordingly.

The system is aligned to the plan and ready to switch from automatic mode to Motion Monitoring mode after flashing for 5 seconds.

The system is aligned to the plan and ready to switch from manual mode to Motion Monitoring mode after flashing for 5 seconds.

Page 28

Product Description

User interface

Warning screens

Warnings are displayed by three different exception screens.

Exception Screen Details

Auto Recovery Exception

An error occurred and is indicated by a symbol followed by an error code. For definitions of the symbols, refer to “List of warning and error symbols” on page 26.

For definitions of the error codes, refer to “Autoguide Control Unit error codes” on page 94.

The notification automatically disappears when the error condition is resolved (for example, plugging in disconnected cables).

Confirmable Exception

An error or notifiable event occurred, as indicated by the symbol. An error code, if applicable, provides detailed identification. For definitions of the symbols, refer to “List of warning and error symbols” on page 26.

For definitions of the error codes, refer to “Autoguide Control Unit error codes” on page 94.

After checking or resolving the cause of the notification, press the joystick to confirm. When the error condition is resolved, the notification disappears. For example, the notification indicating a change to the current plan will disappear after the joystick is pressed.

If the visual indicators of the Autoguide Targeting Unit are not working, the Emergency Behavior Mode symbol is displayed. This indicates limited functionality. Contact Medtronic for technical support.

Stop Exception

An error occurred and is indicated by a symbol followed by an error code. For definitions of the symbols, refer to “List of warning and error symbols” on page 26.

No further operation is possible. Restart the Autoguide Control Unit. If this notification is recurring after a restart, contact Medtronic for technical support.

List of warning and error symbols

The error number #### next to the symbol indicates the root cause and provides additional information if problem escalation is required.

For definitions of the error codes, refer to “Autoguide Control Unit error codes” on page 94.

Page 29

Product Description

User interface

Symbol Description Type of exception

Surgical plan has been changed Confirmation is necessary.

Cable fault Auto recovery

Collision warning Confirmable

Confirmable

In combination with a Stop symbol : Joystick hardware fault No further operation possible. Restart the Autoguide Control

Unit. If this notification is recurring after a restart, contact Medtronic for technical support.

In combination with a Confirm symbol : Joystick use error Release the joystick to its center position and repeat the

procedure.

Enable button fault Confirmable

Autoguide Targeting Unit fault with the illuminated symbols After confirmation, the system continues in emergency

behavior mode.

Over temperature fault Stop exception

Hardware fault Stop exception

Stop exception or Auto recovery

Confirmable

Service needed Stop exception

Speed fault Confirmable

SD card error Confirmable

Page 30

Product Description

User interface

Symbol Description Type of exception

Configuration error Stop exception

Communication with the StealthStation during movement to plan

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system was lost

Confirmable

Service mode

The system can be switched into a Service mode which provides a more detailed view of the current configuration.

To enter the Service mode, press the Move to Home button for at least 3 seconds during startup of the Autoguide Control Unit firmware. The first screen shows serial numbers, version information, the name of the supported tracker tool, system runtime, and the current IP configurations. The second screen shows a list of five pre-configured IP addresses of StealthStation automatic and manual mode buttons to switch between the screens.

To leave the service mode, press the Move to Home button for at least 3 seconds. This automatically restarts the firmware.

Figure 8: Service mode screens

™

systems. Use the

EMC Silent mode

The EMC Silent mode temporarily turns off power to the Autoguide Targeting Unit, which minimizes emissions in the surgical area by maintaining power only to the Autoguide Control Unit. After recovering from the EMC Silent mode, normal operation continues.

Starting the EMC Silent mode

To start the EMC Silent mode, press the Manual mode button for at least 3 seconds. As the power supply of the Autoguide Targeting Unit is switched off, none of the symbols can be illuminated. The reachability and deviation from plan information on the display of the Autoguide Control Unit is updated as usual if there is an active connection to the StealthStation movements cannot be initiated during EMC silent mode.

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system. Manual or automatic

Page 31

Product Description

User interface

Figure 9: System in EMC Silent mode

Stopping the EMC Silent mode

To stop the EMC Silent mode, press the Manual Mode or Automatic Mode button for at least 2 seconds. This activates either manual or automatic motion control mode.

Audio feedback

There are two kinds of audio feedback signals generated by the Autoguide Control Unit:

• Positive or negative feedback beep, with different tones. This beep is emitted during system operation to indicate an action is allowed or denied.

Positive feedback signals have a higher pitch and are emitted to:

– Notify when the surgical plan has been changed

– Indicate that a movement to home position finished successfully

– Indicate that a movement to plan finished successfully

Negative feedback signals have a lower pitch and are emitted when pressing a button that is not allowed or is not meaningful in the current context. For example, a low-pitched beep will sound when pressing the Move to Home button when the system is not in Automatic mode.

• Periodic beeps for error conditions. Periodic beeping and the red blinking power LED on the Autoguide Control Unit occur during a major system fault.

To stop the periodic beeps, power off the system.

Page 32

Product Description

User interface

Page 33

3 Operation and Frequently Used

Functions

Starting the system

1. Press the Power button on the Autoguide Control Unit. For the location of the button, refer to

“Autoguide Control Unit” on page 20.

2. Wait a few seconds until the Boot-up screen disappears and the current system status is displayed. For more information about the system status displays, refer to “Main operation screens” on page 21.

Stopping the system

The following options safely stop the system:

• In Automatic mode, release either the Move or the Enable button at the Autoguide Control Unit to stop the system movement.

• In Manual mode, release either the joystick or the Enable button at the Autoguide Control Unit to stop the system movement.

• To power-down the system, press the Power button on the Autoguide Control Unit until the screen turns dark.

• The system stops if a cable is disconnected during motion.

Note: If the network cable is disconnected, the system only stops automatic motion to a plan.

• The system does not move when fault conditions exist. Fault conditions are indicated by a

warning symbol in the display of the Autoguide Control Unit. Refer to “Warning screens” on page 26 for more information about fault conditions.

• There is no emergency stop button. In case of an emergency, stop the system by turning off the power to the system. Refer to “Emergency shutdown” on page 85.

Moving the system

There are 2 motion modes to operate the system.

• Manual mode (controlled by the joystick)

• Automatic mode (move to home position and alignment to the surgical plan)

After system startup, the Automatic mode is active by default.

Page 34

Operation and Frequently Used Functions

Moving the system

To switch between the different motion modes, use the Mode button on the Autoguide Control Unit. In both modes, movement can occur only if the blue Enable button is pressed.

• Press to select Automatic mode

• Press to select Manual mode

The motion mode is indicated by the corresponding symbol on the Autoguide Control Unit screen.

Figure 10: Toggling between motion modes

Manual mode

Figure 11: Initiating manual moves

On the Autoguide Control Unit, press to change to Manual mode.

• To move the end-effector forward, backward, left, or right, press and hold the Positioning button and then use the joystick to move the Autoguide Targeting Unit. Grasp the top of the joystick

and tilt it in the direction that you want to move the end-effector.

• To change the angulation of the end-effector, press and hold the Angulation button and then

use the joystick to move the Autoguide Targeting Unit.

Page 35

Automatic mode

At the Autoguide Control Unit, press to change to Automatic mode.

Move to home position

At the Autoguide Control Unit, press and hold the Move to Home button and then press and hold one of the Enable buttons (angulation or positioning ). The Autoguide Targeting Unit automatically moves to the home position.

Operation and Frequently Used Functions

Moving the system

Figure 12: Activating movement to the home position

An active move-to-home sequence is indicated by a flashing symbol. This symbol turns to and an audible beep indicates movement is finished and the Autoguide Targeting Unit has reached the home position.

Temporarily releasing the Enable button pauses the movement. Pressing the Enable button again resumes the motion.

Releasing the Move to Home button aborts the move to home procedure.

Automatic alignment to the surgical plan

Figure 13: Activating alignment to plan

Alignment to the surgical plan is only possible when all of the following conditions are achieved:

• There is a connection to the StealthStation

• The tracker tools are visible

• A surgical plan has been created in the StealthStation

reachable by the Autoguide Targeting Unit

™

system

™

Cranial software and the plan is

Page 36

Operation and Frequently Used Functions

Adjusting the speed of the Autoguide Targeting Unit’s movement

At the Autoguide Control Unit, press and hold the Move to Plan button and then press and hold one of the Enable buttons (angulation or positioning ). The Autoguide Targeting Unit automatically moves to align to the plan.

An active alignment sequence is indicated by a flashing symbol. This symbol turns to and an audible beep indicates when movement is finished and the Autoguide Targeting Unit is successfully aligned to the plan.

Temporarily releasing the Enable button pauses movement; pressing the Enable button again resumes the motion.

Releasing the Move to Plan button aborts the alignment procedure.

During movement, if the Stealth Autoguide system pauses motion and displays the flashing Visibility symbol . The system remains in a waiting state until visibility is restored or the user releases the Move to Plan button .

™

Tracker or the patient reference frame is not visible, the

Adjusting the speed of the Autoguide Targeting Unit’s movement

There are 2 speed modes, normal and slow.

After system startup, the Normal Speed mode is active by default. After you select one of the speed settings, it will not change until you select a different speed setting or you restart the system.

Figure 14: Adjusting speed mode

Press the button on the Autoguide Control Unit to activate the Normal Speed mode.

Press the button on the Autoguide Control Unit to activate the Slow Speed mode.

The current speed mode is indicated by the corresponding symbol on the Autoguide Control Unit screen.

Page 37

Preparing the system

Operation and Frequently Used Functions

Preparing the system

After bringing sterile disposables and the Autoguide Reusable Devices Sterilization Container into the operating room, roll the Stealth Autoguide outside of the sterile field. Position the StealthStation

Prepare the patient per hospital procedure. The system can be mounted after the patient’s head is fixated in the patient head clamp.

Connecting the cables

Caution: The power cord should be easily accessible to allow for an easy disconnection from power,

in case of major system fault.

Note: The connectors are uniquely shaped, and therefore, it is not possible to plug a cable into a

wrong connector. To facilitate finding the correct connector, each plug-receptacle combination is color-coded.

Refer to Figure 16 for a cabling overview.

1. Connect the power cord to the Autoguide Power and Network Unit and rotate the plug clockwise until it clicks to the locked position (refer to Figure 16).

2. Plug the power cord directly into an electrical outlet.

3. Connect the network cable to the Autoguide Power and Network Unit and the StealthStation

system.

™

Cart to the vicinity of the operating room table,

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system.

™

Caution: The network connection to the StealthStation

directly, without use of any hub, switch, router, or equivalent device, to avoid any impairment of performance.

4. Connect the Autoguide Power and Network Unit Cable to the Autoguide Power and Network Unit and the Autoguide Strain Relief Box.

5. Place the Autoguide Power and Network Unit in a location that does not obstruct movement around the operating room table.

6. Connect the Autoguide Strain Relief Box to the side-rail of the operating room table.

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system must only be established

Page 38

Operation and Frequently Used Functions

Preparing the system

7. Press the silver button on the Autoguide Strain Relief Box to separate the outward facing portion of the box from the bed rail connection.

8. Connect the Autoguide Control Unit to the Autoguide Strain Relief Box using the Autoguide Control Unit Cable.

Figure 15: Mounting the Autoguide Strain Relief Box

9. Connect the Autoguide Targeting Unit Cable Set to the Autoguide Strain Relief Box. The cables

are interchangeable.

Note: You will connect the Autoguide Targeting Unit Cable Set to the Autoguide Targeting Unit

in a later step in “Mounting the system” on page 37.

10. Reconnect the outward facing portion of the Autoguide Strain Relief Box to the bed rail connection.

Page 39

Operation and Frequently Used Functions

Figure 16: Connecting cables

Preparing the system

Mounting the system

1. Remove the Autoguide Head Clamp Adapter and coupling from the Stealth Autoguide™ Cart and assemble them together. Mount the Autoguide Head Clamp Adapter to the patient head clamp using the starburst connector.

Warning: Ensure that all mating connections at the Autoguide Head Clamp Adapter are fully

seated and have a snug fit. If the Autoguide Head Clamp Adapter is not mounted properly, the patient may be injured.

1 Fixation plug for the Autoguide Targeting Unit Cable Set 2 Autoguide Strain Relief Box 3 Autoguide Power and Network Unit

A. To connect the power cord to the Autoguide Power and Network Unit, rotate the plug clockwise until it clicks to the locked position.

B. To disconnect the power cord, slide the yellow locking mechanism away from the Autoguide Power and Network Unit, rotate the power cord plug counter clockwise, and disconnect the cord from the unit.

4 Autoguide Control Unit

Page 40

Operation and Frequently Used Functions

Preparing the system

Warning: Ensure that the Autoguide Head Clamp Adapter is connected only to the patient head

clamps whose load and torque specifications are at least 60 newtons and 20 newton meters, respectively. Using patient head clamps that are not capable of withstanding loads and torques in the indicated range may result in patient injury.

Figure 17: Assembling the Autoguide Head Clamp Adapter and coupling

2. Mount the Vertek

™

II Arm, with the non-sterile Passive Cranial Reference Frame, to the Autoguide Head Clamp Adapter at any of the 4 mounting points available. Refer to the instructions for use that accompany the Vertek

™

II Arm.

Figure 18: Mounting the Vertek™ II Arm

3. Perform patient registration following the instructions for use that accompany the

StealthStation

™

Cranial navigation software.

Note: Alternatively, proceed with the remaining steps to mount the Stealth Autoguide™ system

and connect the cables. Then perform patient registration after the system is mounted and connected to the StealthStation

™

system.

4. Mount the Autoguide Positioning Arm at any of the 3 remaining starburst mounts on the Autoguide Head Clamp Adapter.

Warning: Ensure that all mating connections at the Autoguide Head Clamp Adapter are fully

seated and have a snug fit. If the Autoguide Head Clamp Adapter is not mounted properly, the patient may be injured.

Page 41

Operation and Frequently Used Functions

Preparing the system

Figure 19: Mounting the Autoguide Positioning Arm

5. Mount the Autoguide Targeting Unit to the Autoguide Positioning Arm using one of the 3

starburst connectors on the bottom of the Autoguide Targeting Unit.

Figure 20: Mounting points on the Autoguide Targeting Unit

6. If required, adjust the Autoguide Positioning Arm into a different position:

a. Slide the ratchet lock and unlock button on the ratchet handle to the unlocked position and

rotate the ratchet handle back and forth a few times until all 3 arm joints are loose.

b. Move the Autoguide Positioning Arm into the desired position.

c. Slide the ratchet lock and unlock button on the ratchet handle to the locked position and rotate

the ratchet handle back and forth a few times until all 3 arm joints are tight.

Warning: Keep the ball joints of the Autoguide Positioning Arm clean and ensure that all mating

connections (starburst adapters) to the Autoguide Positioning Arm are fully seated and have a snug fit. If the Autoguide Positioning Arm is not mounted properly, the patient may be injured.

Warning: Do not start or continue with the surgical procedure if there is evidence that the

support arm has lost its ratchet function. Loss of ratchet function may result in an unstable mechanical setup and a compromised surgical procedure.

Page 42

Operation and Frequently Used Functions

Preparing the system

Figure 21: Ratchet mechanism on the Autoguide Positioning Arm

1 Ratchet lock and unlock button 2 Ratchet handle

7. Make sure that no fracturing, fraying, or chafing exists on the housings or covers of the Autoguide Targeting Unit and the Autoguide Control Unit.

Warning: Do not use the Autoguide Targeting Unit or the Autoguide Control Unit with a broken

housing or covers. Sharp edges on a defective Autoguide Targeting Unit or Autoguide Control Unit housing or covers may cause user injury or breach sterile drapes.

8. Make sure the blue cover tape of the Autoguide Targeting Unit is not ruptured.

Caution: Do not use the Autoguide Targeting Unit with a broken housing or broken cover tape.

Defective Autoguide Targeting Unit housing or covers may cause functional or motion impairment, and the impairment may delay the surgical workflow.

If the blue cover tape is ruptured, abort use of the Stealth Autoguide Medtronic for technical support.

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system and contact

Page 43

Operation and Frequently Used Functions

Preparing the system

Figure 22: Autoguide Targeting Unit covers, cover tape, and housing

1 Covers 2 Cover tape 3 Housing

9. If required, adjust the mounting point of the Autoguide Targeting Unit on the Autoguide Positioning Arm (refer to Figure 23).

Warning: Before starting the surgical procedure, make sure that the Autoguide Head Clamp

Adapter, Autoguide Positioning Arm, and Autoguide Targeting Unit are securely connected and can withstand procedural forces that may cause joint slippage or instability. If these components are not stable, the patient may be injured.

Figure 23: Three mounting points on the Autoguide Targeting Unit

10. Connect the Autoguide Targeting Unit Cable Set to the Autoguide Targeting Unit. Secure the

cable strain relief by pushing the pin into either of the 2 holes in the starburst adapter of the Autoguide Positioning Arm.

Page 44

Operation and Frequently Used Functions

Preparing the system

11. Gently try to move the Autoguide Targeting Unit away from its position by applying vertical and lateral forces to check that the setup is stable.

If the setup is not stable, repeat the steps to mount the system and make sure that the ratchet knob on the Autoguide Positioning Arm has been sufficiently tightened.

Warning: Ensure that the Autoguide Targeting Unit Cable Set is properly fixated to the starburst

adapter of the Autoguide Positioning Arm by inserting its fixation pin into the hole in the arm, making sure the cables are free to move with the Autoguide Targeting Unit. If the Autoguide Targeting Unit Cable Set is improperly mounted, or cables improperly routed, the patient may be injured.

Caution: Make sure that the system components are securely connected and can withstand

procedural forces that may cause joint slippage or system instability. Severe damage of the equipment is possible.

Page 45

Operation and Frequently Used Functions

Draping the system and inserting the end-effector

Wash and prepare the patient per hospital procedure. Then follow the steps in this section to drape the system.

Draping the Autoguide Control Unit

1. Power on the Autoguide Control Unit.

2. Move the Autoguide Targeting Unit to the home position. At the Autoguide Control Unit, press

and hold the Move to Home button and then press and hold one of the Enable buttons (angulation or positioning ). The Autoguide Targeting Unit automatically moves to the home position.

Figure 24: Activating movement to the home position

Preparing the system

3. Make sure that the system successfully established a connection to the StealthStation system.

When a connection is established, the Network symbol changes to the StealthStation system Connection symbol .

4. Position the Autoguide Targeting Unit for subsequent sterile draping.

5. Drape the Autoguide Control Unit and place it on the sterile table:

a. Place your hands inside the drape and open it sufficiently to slide it over the Autoguide

Control Unit.

b. Slide the drape over the Autoguide Control Unit.

c. Pull the drape down completely and make sure the cable is covered.

d. Optionally, close the distal drape opening using the tape delivered with the drape.

™

6. Roll the Stealth Autoguide

Cart out of the vicinity of the operating room table.

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Page 46

Operation and Frequently Used Functions

Preparing the system

Draping the Autoguide Targeting Unit and the Autoguide Positioning Arm

1. Check for the presence of any wet surfaces on the Autoguide Targeting Unit. If present, dry

them.

2. Partially unfold the Autoguide Targeting Unit Sterile Drape on the sterile table.

Warning: Make sure that the sterile drape is not tangled with the Autoguide Positioning Arm or

the Autoguide Targeting Unit. A tangled drape may result in an unstable mechanical setup and a compromised surgical procedure.

3. On the sterile table, mount the Autoguide Guiding Joints to the Autoguide Targeting Unit Sterile Drape using the integrated drape clips.

Do not separate the clips from the drape. Make sure the drape is securely sealed to the Autoguide Guiding Joints.

Warning: Assemble the Autoguide Guiding Joints into the Autoguide Targeting Unit Sterile

Drape clips before draping the Autoguide Targeting Unit in a sterile area of the operating room. Failure to do this can compromise the sterility of the sterile area. Risk of patient injury.

Figure 25: Mounting the Autoguide Guiding Joints to the Autoguide Targeting Unit Sterile Drape clips

4. Place your hands inside the drape and open it sufficiently to slide it over the Autoguide

Targeting Unit.

5. Pull the drape down completely and make sure the Autoguide Positioning Arm handle is covered.

Note: Drape the Autoguide Targeting Unit and its cables and the Autoguide Positioning Arm. The

drape must be loose enough to permit movement of the upper and lower halves of the Autoguide Targeting Unit.

Page 47

Operation and Frequently Used Functions

Preparing the system

Figure 26: Sliding the drape over the Autoguide Targeting Unit

6. Mount the Autoguide Guiding Joints to the Autoguide Targeting Unit.

Check for alignment of the white markings on the release buttons (see Figure 28). Then, make sure the connection is secure by gently pushing and pulling the Autoguide Guiding Joints toward and away from the Autoguide Targeting Unit. Make sure there is no interference with the drape.

Figure 27: Inserting the Guiding Joints into the Autoguide Targeting Unit

Page 48

Operation and Frequently Used Functions

Preparing the system

Figure 28: Release buttons and white markings on the Autoguide Targeting Unit

7. After the Autoguide Targeting Unit is draped and the Autoguide Guiding Joints are assembled,

follow these steps to confirm that the Autoguide Targeting Unit can be moved safely by hand:

a. Position yourself away from the patient.

1 Release buttons 2 White markings (aligned)

b. Unlock the Autoguide Positioning Arm with one hand, hold the Autoguide Targeting Unit with

the other hand, and park it in another position.

c. If slippage occurs, exchange the drape or investigate if there is any fluid on the top lid of the

Autoguide Targeting Unit that may be causing the slippage.

8. Confirm that the selected surgical plans can be reached with the existing setup and that no slippage or collisions occur.

9. Complete patient draping and exchange the non-sterile Passive Cranial Reference Frame with a sterile one, following the instructions for use that accompany the StealthStation navigation software.

Setting up the end effector

Note: If inserting an instrument is difficult in any of the following workflow steps that involve

tightening screws on guides, inserts, or reducing tubes, verify the position of the thumb screws. If thumb screws are only partially loosened, they may block the insertion.

Note: The thumb screws can fall out if excessively loosened.

1. Attach the Autoguide Upper Guiding Insert and the Autoguide Lower Guiding Insert to the

Autoguide Guiding Joints.

• Make sure the Guiding Inserts are positioned in a 90° orientation before inserting them into

the slots on the Autoguide Guiding Joints (notice the arrows, which indicate the insertion direction into each Guiding Joint).

• Make sure the Guiding Inserts are fully inserted into the Guiding Joint slots before rotating to

the final orientation. When the Upper Guiding Insert is in its final orientation, the open portion faces away from the Autoguide Targeting Unit. When the Lower Guiding Insert is in its final orientation, the thumbscrew faces away from the Autoguide Targeting Unit.

™

Cranial

Page 49

Operation and Frequently Used Functions

Preparing the system

• Make sure the smaller hole of the Autoguide Lower Guiding Insert is facing down in the guiding joint.

Figure 29: Inserting the Guiding Inserts

Page 50

Operation and Frequently Used Functions

Preparing the system

2. For Brain Biopsy and sEEG cases, introduce the Autoguide Stab Incision Height Guide from below into the Stealth Autoguide™ Tracker. The round tip must face up and the verification pointer must face down. The Autoguide Stab Incision Height Guide clicks into place when its retaining ring is fully seated in the Stealth Autoguide

™

Tracker.

For Visualase™ cases, introduce the Autoguide Visualase™ Height Guide from below into the Stealth Autoguide down. The Autoguide Visualase seated in the Stealth Autoguide

™

Tracker. The round tip must face up and the verification pointer must face

™

Height Guide clicks into place when its retaining ring is fully

™

Tracker.

Figure 30: Inserting height guides

3. Fixate the selected height guide in the Stealth Autoguide™ Tracker by locking the thumb screw.

Figure 31: Fixating the height guide (for example, Height Guide, Stab Incision)

4. Verify the Stealth Autoguide

™

Tracker:

a. Place the verification tip in one of the divots of the Passive Cranial Reference Frame. Ensure

that the Stealth Autoguide

™

Tracker’s optical markers are facing toward the camera.

Page 51

Operation and Frequently Used Functions

b. Wait until a sound or an on-screen indicator on the StealthStation

successful verification.

Figure 32: Verifying the Stealth Autoguide

™

Tracker at the Passive Cranial Reference Frame

Preparing the system

™

system signifies a

5. Loosen the locking thumb screw and remove the height guide.

6. Flip the height guide over and reinsert it into the Stealth Autoguide™ Tracker, with the round tip

facing down.

7. Retract the top end (verification pointer) of the height guide out of the Stealth Autoguide

™

Tracker to adjust the set-up distance between the Autoguide Targeting Unit and the patient to account for skin thickness. As the height guide is pulled back, each marking on the height guide accounts for about 5 mm.

Page 52

Operation and Frequently Used Functions

Preparing the system

Figure 33: Inserting the round tip of the height guide in the Stealth Autoguide

height guide

™

Tracker and fixating the

8. After the appropriate offset has been set on the height guide, fixate the height guide in the Stealth Autoguide

™

Tracker using the thumb screw.

9. Insert the Stealth Autoguide™ Tracker in the guiding inserts that have been previously mounted to the Autoguide Targeting Unit.

a. Make sure the Stealth Autoguide

™

Tracker has been fully seated in the Autoguide Lower

Guiding Insert.

The position indicator marked ring on the Stealth Autoguide

™

Tracker should be obscured by the marked limit stops on the Autoguide Lower Guiding Insert. When the position indicators are aligned properly, the Stealth Autoguide

™

Tracker rotation will be constrained by limit stops on the Lower Guiding Insert. A tactile and audible “snap” can also be detected as the Stealth Autoguide

b. Fixate the Stealth Autoguide

™

Tracker completes its engagement into the Lower Guiding Insert.

™

Tracker’s rotational position using the thumb screw marked

“TRACKER” on the Autoguide Lower Guiding Insert.

Warning: Confirm stability of the complete end-effector before starting the surgical procedure.

An unstable mechanical setup of the Stealth Autoguide

™

Tracker, Autoguide Guiding Joints,

and guiding inserts may result in injury.

Page 53

Figure 34: Inserting the Stealth Autoguide

Operation and Frequently Used Functions

Preparing the system

™

Tracker in the guiding inserts

Page 54

Operation and Frequently Used Functions

Gross-positioning and alignment

1. Confirm that the Autoguide Targeting Unit can be held and manipulated without slippage under

the drape.

2. Ensure that the Autoguide Targeting Unit is in home position to show reachability information.

Figure 35: Autoguide Targeting Unit in home position

3. Unlock the Autoguide Positioning Arm and touch the patient’s scalp with the round tip of the

height guide.

4. Move the Autoguide Targeting Unit toward the entry point. Monitor the position and orientation of the system and the distance to the entry point at the StealthStation on the top lid of the Autoguide Targeting Unit indicate if the surgical plan is within reach for an automatic alignment.

™

system. The indicators

Page 55

Operation and Frequently Used Functions

Gross-positioning and alignment

Figure 36: Surgical plan within reach for automatic alignment

5. When the symbols on the Autoguide Targeting Unit and Autoguide Control Unit indicate that the

active surgical plan is within reach, lock the Autoguide Positioning Arm.

Warning: Ensure proper gross-positioning at the beginning of the surgical procedure.

Inadequate gross-positioning may prevent the system from aligning with the active surgical plan. Risk of injury or a compromised surgical procedure.

6. Ensure that the large round tip of the height guide is still in contact with the scalp.

If the height guide does not touch the scalp, reposition the Autoguide Targeting Unit.

7. Loosen the locking thumb screw on the Stealth Autoguide

™

Tracker and remove the height

guide.

Figure 37: Removing the height guide

8. To check that the setup is stable, gently try to move the Autoguide Targeting Unit away from its

position by applying vertical and lateral forces. If the setup is not stable, repeat the previous steps and make sure that the ratchet knob on the Autoguide Positioning Arm has been sufficiently tightened.

Page 56

Operation and Frequently Used Functions

Detecting deviations

9. Make sure there are no instruments remaining in the guiding bore of the Stealth Autoguide Tracker.

™

Warning: Remove any surgical tools from the Stealth Autoguide

manual movement of the Autoguide Targeting Unit. Surgical tools mounted to the Stealth Autoguide

10. Command the system to align with the active surgical plan. At the Autoguide Control Unit, press and hold the Move to Plan button and then press and hold one of the Enable buttons (angulation or positioning ). The Autoguide Targeting Unit moves to automatically align to the plan.

Warning: Automatic movements are canceled when the Enable button is released. Failing to hold

the Enable button for the complete course of movement may cause delays to the procedure.

Warning: Pay attention to potential collisions between the end-effector and the patient’s anatomy or

previously placed sEEG bolts during automatic movements. Such collision may lead to an inaccurate bolt placement.

™

Tracker during movement of the Autoguide Targeting Unit may cause injuries.

Figure 38: Activating alignment to plan

™

Tracker before automatic or

11. If desired, the entry point can be marked with the drill guide by applying ink from a surgical pen to the teeth and then sliding the drill guide through the Stealth Autoguide contacts the skin.

Detecting deviations

Five seconds after aligning to the active surgical plan, the system initiates a Motion Monitoring mode (indicated by the symbol). This mode compares the current position of the Stealth Autoguide Tracker with the active surgical plan to detect deviations of 1.0 mm or more.

Figure 39: Motion Monitoring mode (left), indication of deviation of 1.0 mm or more (right)

A deviation is indicated on the Autoguide Control Unit by flashing of these symbols .

The Aligned symbol on the Autoguide Targeting Unit flashes .

™

Tracker until it

™

Page 57

Operation and Frequently Used Functions

Detecting deviations

™

If a deviation is detected after this point during the workflow, refer to the StealthStation

system monitor to evaluate the magnitude of the deviation and whether or not it is acceptable for the procedure.

• If the deviation is acceptable, proceed with the workflow and take additional care to avoid lateral

or vertical forces on the system.

• If the deviation is unacceptable, stop the current task, remove any instruments or devices from

the Stealth Autoguide

™

Tracker, and either repeat the workflow steps to re-align to an acceptable

level or cancel the clinical procedure.

Cancel Motion Monitoring mode by selecting the Automatic or Manual mode to be able to move the Autoguide Targeting Unit for realignment.

Note: The Motion Monitoring mode is automatically canceled after 5 seconds if the Autoguide

Targeting Unit is repositioned using the Autoguide Positioning Arm.

The StealthStation

™

system is the primary source of alignment and accuracy information. The symbols on the Autoguide Control Unit’s display and on the Autoguide Targeting Unit are only complementary information.

Warning: Always consult the StealthStation

™

system display for current trajectory alignment information. Alignment information at the Autoguide Targeting Unit may be outdated. Failure to consult the StealthStation

™

system display may result in patient injury or a compromised surgical

procedure.

Warning: Do not correct a misaligned position while a surgical tool is mounted to the Stealth

Autoguide

™

Tracker or touching the patient anatomy. Remove any surgical tools before automatic or manual movements of the Autoguide Targeting Unit. Surgical tools mounted to the Stealth Autoguide

™

Tracker during movement of the Autoguide Targeting Unit may cause

injuries.

Page 58

Operation and Frequently Used Functions

Performing surgical procedures

This section describes how to use the system components when performing the following surgical procedures:

• Stab Incision Biopsy. Refer to “Stab incision biopsy” on page 56.

• Burr Hole Biopsy. Refer to “Burr hole biopsy” on page 63.

• sEEG bolt placement. Refer to “sEEG bolt placement” on page 68.

• Visualase™ Bone Anchor Placement. Refer to “Visualase™ bone anchor placement” on page 76.

All of the surgical procedures have the prerequisite that the system is aligned with the active surgical plan.

Stab incision biopsy

The following equipment is needed for a stab incision biopsy procedure:

Autoguide Stab Incision Drill Guide

Autoguide Stab Incision Obturator

Autoguide Tapping Tube

Autoguide Stab Biopsy 2.2 mm Reducing Tube

Surgical hammer (not provided by Medtronic)

Legend™ Depth Stop Twist Drill 3.2 mm Stab Biopsy Tool (DS1TD32)

Legend™ Depth Stop Attachment (ASDS01)

Midas Rex™ Legend™ motor

Medtronic Navigated Biopsy Needle

(Equipment is not shown to scale.)

Page 59

Operation and Frequently Used Functions

Performing surgical procedures

1. Inspect all surgical instruments for damage before and after each use. Do not use any product that appears to be damaged or excessively worn. Any product that shows damage including, but not limited to, corrosion, rust, cracks, bending, illegible markings, damaged threads, dull sharp edges, damaged bearings, or separation of joints is at the end of its useful life. Dispose of the product according to national regulations.

Warning: Replace any device that appears to be damaged because a damaged device may

cause inaccuracy or patient harm.

2. Create a skin incision.

Figure 40: Skin incision

3. Insert the Autoguide Stab Incision Drill Guide into the Stealth Autoguide

by tightening the thumb screw on the Stealth Autoguide

™

Tracker. The drill guide must be

™

Tracker and secure it

slightly retracted in order not to touch the skin.

Warning: Ensure that the fixation screw on the Stealth Autoguide

™

Tracker is always locked after placing a surgical instrument into position. Failing to lock the fixation screw may result in a displacement of the surgical instrument and patient injury.

Page 60

Operation and Frequently Used Functions

Performing surgical procedures

Figure 41: Autoguide Stab Incision Drill Guide in the Stealth Autoguide

4. Insert the Autoguide Stab Incision Obturator in the Autoguide Stab Incision Drill Guide until it

makes contact with the skull.

Figure 42: Autoguide Stab Incision Obturator in the drill guide

™

Tracker

5. Use a surgical hammer to temporarily anchor the Autoguide Stab Incision Obturator at the skull.

The obturator will provide guidance for the subsequent anchoring of the Autoguide Stab Incision Drill Guide.

Warning: Use only enough force to achieve a stable connection with bone when anchoring

surgical tools on the skull. High forces when anchoring surgical tools may lead to injuries or inaccurate positioning.

6. Unlock the Autoguide Stab Incision Drill Guide and lower it until it makes contact with the skull. Enlarge the skin incision if necessary.

Page 61

Operation and Frequently Used Functions

Performing surgical procedures

Figure 43: Lowering the Autoguide Stab Incision Drill Guide

7. Slide the Autoguide Tapping Tube over the Autoguide Stab Incision Obturator. Make sure the

lower end of the Autoguide Tapping Tube is contacting the shoulder on the Autoguide Stab Incision Drill Guide.

Figure 44: Autoguide Tapping Tube over the obturator

8. Use the index finger or the thumb to hold the Autoguide Stab Incision Obturator in place.

Page 62

Operation and Frequently Used Functions

Performing surgical procedures

Figure 45: Holding the Autoguide Stab Incision Obturator in place

9. To avoid transmitting force on the entire system during hammering, make sure the thumb screw

™

on the Stealth Autoguide

Tracker is loosened before using a surgical hammer to anchor the

drill guide.

10. Use a surgical hammer to anchor the drill guide teeth at the skull. Carefully try to rotate the drill guide to confirm stable anchoring. If the drill guide resists movement, it is anchored. Lock its position using the thumb screw on the Stealth Autoguide

™

Tracker without misaligning the

surgical plan.

Figure 46: Locking the drill guide in position

11. Remove the Autoguide Tapping Tube and Autoguide Stab Incision Obturator.

Page 63

Operation and Frequently Used Functions

Performing surgical procedures

Figure 47: Removing the Autoguide Tapping Tube and Autoguide Stab Incision Obturator

12. Check the Target Alignment Error on the StealthStation™ screen to determine whether the

error is still within an acceptable range after hammering to anchor the drill guide.

If the Target Alignment Error is not acceptable, remove the drill guide from the Stealth Autoguide

™

Tracker and repeat the process of aligning to plan and introducing the drill guide,

obturator, and tapping tube.

13. Prepare the Midas Rex Biopsy Tool (DS1TD32) and the Legend

™

drill assembly: Install the Legend™ Depth Stop Twist Drill 3.2 mm Stab

™

Depth Stop Attachment (ASDS01) following the

instructions for use that accompany the drill system.

Warning: Use only non-navigated Midas Rex™ Legend™ High Speed Drills together with the

surgical instruments of the Stealth Autoguide

™

system. Use of non-Medtronic drill systems

for creating cranial holes may result in a compromised surgical procedure.

14. Insert the Midas Rex

™

drill assembly in the drill guide and drill the hole in the skull following the

instructions for use that accompany the drill system. While drilling, flush with water.

Warning: Do not apply high lateral forces while drilling a hole in the skull. Lateral forces while

drilling a hole in the skull may lead to a deficient surgical procedure, such as elongated holes or mispositioned trajectory alignment.

Warning: Perform proper flushing, cooling, and irrigation during drilling to prevent entrance of

debris into the brain, temperature increase, and potential patient injuries due to those factors.

Warning: Touching the brain or other tissue with a functioning drill may lead to severe patient or

user injury. The Stealth Autoguide

™

system and accessories are not intended for contact with

the central nervous system.

15. When finished, remove the Midas Rex

™

drill assembly.

16. Breach the dura.

17. Insert the Autoguide Stab Biopsy 2.2 mm Reducing Tube. The two pins on the reducing tube

must be placed into the slots on the drill guide completely, such that the pins rest on the shoulder of the Stealth Autoguide

™

Tracker.

Page 64

Operation and Frequently Used Functions

Performing surgical procedures

18. If the Target Alignment Error in the StealthStation™ Cranial software is acceptable, lock the trajectory either by clicking [Lock Trajectory] on the software screen or by pressing the StealthStation

™

19. Prepare the Medtronic Navigated Biopsy Needle and set the depth stop at the correct position,

following the instructions for use that accompany the Navigated Biopsy Needle.

Figure 48: Inserting the reducing tube

system footswitch.

Warning: Refer to the tip stop point in the navigation software when setting the depth stop on

the biopsy needle. The software automatically calculates the tip stop point. The tip stop point is the distance from the top surface of the reducing tube to the biopsy target.

20. Harvest tissue following the instructions for use that accompany the Medtronic Navigated Biopsy Needle.

Warning: Use only Medtronic Navigated Biopsy Needles with the Stealth Autoguide

™

system. Use of other biopsy needles for tissue harvesting may result in a compromised surgical procedure.

Page 65

Burr hole biopsy

The following equipment is needed for a burr hole biopsy procedure:

Operation and Frequently Used Functions

Performing surgical procedures

Autoguide Burr Hole Drill Guide

Surgical hammer (not provided by Medtronic)

Legend™ Depth Stop Twist Drill 7.5 mm Burr Hole Biopsy Tool (DS1TD75)

Legend™ Depth Stop Attachment (ASDS01)

Midas Rex™ Legend™ motor

Autoguide Burr Hole 2.2 mm Reducing Tube

Medtronic Navigated Biopsy Needle

(Equipment is not shown to scale.)

Warning: Replace any device that appears to be damaged because a damaged device may

cause inaccuracy or patient harm.

2. Cut the skin and muscle with a scalpel and retract it to clear access to bone.

Page 66

Operation and Frequently Used Functions

Performing surgical procedures

Figure 49: Skin incision

3. Insert the Autoguide Burr Hole Drill Guide until it touches the skull.

™

Figure 50: Autoguide Burr Hole Drill Guide in the Stealth Autoguide

Tracker

4. Use a surgical hammer to anchor the drill guide teeth at the skull. Carefully try to rotate the drill guide to confirm stable anchoring. If the drill guide resists movement, it is anchored.

Warning: Use only enough force to achieve a stable connection with bone when anchoring

surgical tools on the skull. High forces when anchoring surgical tools may lead to injuries or inaccurate positioning.

Page 67

Operation and Frequently Used Functions

Performing surgical procedures

Figure 51: Anchoring the Autoguide Burr Hole Drill Guide

™

5. Secure the drill guide by tightening the thumb screw on the Stealth Autoguide

Tracker.

Warning: Ensure that the fixation screw on the Stealth Autoguide™ Tracker is always locked

after placing a surgical instrument into position. Failing to lock the fixation screw may result in a displacement of the surgical instrument and patient injury.

Figure 52: Securing the Autoguide Burr Hole Drill Guide

6. Check the Target Alignment Error on the StealthStation

™

screen to determine whether the

error is still within an acceptable range after hammering to anchor the drill guide.

If the Target Alignment Error is not acceptable, remove the drill guide from the Stealth Autoguide

™

Tracker and repeat the process of aligning to plan and introducing the drill guide,

obturator, and tapping tube.

7. Prepare the Midas Rex Hole Biopsy Tool (DS1TD75) and the Legend

™

drill assembly: Install the Legend™ Depth Stop Twist Drill 7.5 mm Burr

™

Depth Stop Attachment (ASDS01) following the

instructions for use that accompany the drill system.

Warning: Use only non-navigated Midas Rex™ Legend™ High Speed Drills together with the

surgical instruments of the Stealth Autoguide

™

system. Use of non-Medtronic drill systems

for creating cranial holes may result in a compromised surgical procedure.

Page 68

Operation and Frequently Used Functions

Performing surgical procedures

8. Insert the Midas Rex instructions for use that accompany the drill system. Use irrigation while drilling.

Warning: Do not apply high lateral forces while drilling a hole in the skull. Lateral forces while

drilling a hole in the skull may lead to a deficient surgical procedure, such as elongated holes or mispositioned trajectory alignment.

Warning: Perform proper flushing, cooling, and irrigation during drilling to prevent entrance of

debris into the brain, temperature increase, and potential patient injuries due to those factors.

™

drill assembly in the drill guide and drill the hole in the skull following the

Warning: Touching the brain or other tissue with a functioning drill may lead to severe patient or

user injury. The Stealth Autoguide

™

system and accessories are not intended for contact with

the central nervous system.

9. When finished, remove the Midas Rex

™

drill assembly.

10. Breach the dura.

11. Remove the Autoguide Burr Hole Drill Guide.

Figure 53: Removing the Autoguide Burr Hole Drill Guide

12. To ensure better accuracy, realign to the active surgical plan. If the accuracy displayed in the

StealthStation™ system monitor is considered adequate, proceed to the next step. Make sure there are no instruments remaining in the guiding bore of the Stealth Autoguide

™

Tracker

before repeating the alignment.

Figure 54: Realigning to the active surgical plan

13. Insert the Autoguide Burr Hole 2.2 mm Reducing Tube.

Page 69

Operation and Frequently Used Functions

Performing surgical procedures

Figure 55: Insert the Autoguide Burr Hole 2.2 mm Reducing Tube

14. In the StealthStation™ Cranial software, lock the trajectory either by clicking [Lock Trajectory]

on the software screen or by pressing the StealthStation

™

system footswitch.

15. Prepare the Medtronic Navigated Biopsy Needle and set the depth stop at the correct position, following the instructions for use that accompany the Navigated Biopsy Needle.

Warning: Refer to the tip stop point in the navigation software when setting the depth stop on

the biopsy needle. The software automatically calculates the tip stop point.The tip stop point is the distance from the top surface of the reducing tube to the biopsy target.

16. Harvest tissue following instructions for use that accompany the Medtronic Navigated Biopsy Needle.

Warning: Use only Medtronic Navigated Biopsy Needles with the Stealth Autoguide

™

system. Use of other biopsy needles for tissue harvesting may result in a compromised surgical procedure.

Page 70

Operation and Frequently Used Functions

Performing surgical procedures

sEEG bolt placement

The following equipment is needed for sEEG bolt placement:

Autoguide Stab Incision Drill Guide

Autoguide Stab Incision Obturator

Surgical hammer (not provided by Medtronic)

Autoguide Tapping Tube

Legend™ Depth Stop Attachment (ASDS01)

Midas Rex™ Legend™ motor

Legend™ Depth Stop Twist Drill 2.4 mm sEEG Bolt Placement Tool (DS1TD24)

Ad-Tech bolt driver 4.0 mm or 2.4 mm (Ad-Tech bolt drivers are not provided by

Medtronic.)

Autoguide sEEG 2.4 mm Reducing Tube

Autoguide sEEG 4.0 mm Reducing Tube

2.4 mm or 4.0 mm anchor bolt

(Equipment is not shown to scale.)

Warning: Avoid a collision with implanted anchor bolts while manually removing the system from the

surgical area. A collision with already implanted anchor bolts may lead to patient injury or deficient surgical procedure.

Important:

• When placing several bolts, observe the correct sequence.

a. Place first the bolt that will be the farthest away from the Autoguide Targeting Unit’s gross-

position.

b. Place last the bolt that will be closest to the Autoguide Targeting Unit’s gross-position.

c. Select intermediate positions in order to avoid collisions.

If you do not follow this sequence, a previously placed bolt may be in the way when aligning to an active surgical plan, causing a collision and resulting in a displacement of the bolt.

• Before the procedure starts, ensure that the initial setup allows you to reach all places where a sEEG bolt will be placed. If all places cannot be reached with a single gross-positioning, the system allows multiple gross-positionings to reach difficult trajectories.

Page 71

Operation and Frequently Used Functions

Performing surgical procedures

Warning: Replace any device that appears to be damaged because a damaged device may

cause inaccuracy or patient harm.

2. Create a skin incision.

Figure 56: Skin incision

3. Insert the Autoguide Stab Incision Drill Guide into the Stealth Autoguide

™

Tracker and secure it by tightening the thumb screw. The drill guide must be slightly retracted to avoid touching the skin.

Warning: Ensure that the fixation screw on the Stealth Autoguide

™

Tracker is always locked after placing a surgical instrument into position. Failing to lock the fixation screw may result in a displacement of the surgical instrument and patient injury.

Page 72

Operation and Frequently Used Functions

Performing surgical procedures

Figure 57: Autoguide Stab Incision Drill Guide in the Stealth Autoguide

4. Insert the Autoguide Stab Incision Obturator in the drill guide and into the skin until it contacts

the skull.

Figure 58: Autoguide Stab Incision Obturator in the drill guide

™

Tracker

5. Use a surgical hammer to temporarily anchor the obturator at the skull. The obturator will

provide guidance for the subsequent anchoring of the drill guide.

Warning: Use only enough force to achieve a stable connection with bone when anchoring

surgical tools on the skull. High forces when anchoring surgical tools may lead to injuries or inaccurate positioning.

Warning: Perform proper flushing, cooling, and irrigation during drilling to prevent entrance of

debris into the brain, temperature increase, and potential patient injuries due to those factors.

6. Unlock the drill guide and lower it until it makes contact with the skull. Enlarge the skin incision if necessary.

Page 73

Operation and Frequently Used Functions

Performing surgical procedures

Figure 59: Lowering the Autoguide Stab Incision Drill Guide

7. Slide the Autoguide Tapping Tube over the Autoguide Stab Incision Obturator. Make sure the

lower end of the Autoguide Tapping Tube is contacting the shoulder of the drill guide.

Figure 60: Autoguide Tapping Tube over the obturator

8. Use the index finger or the thumb to hold the Autoguide Stab Incision Obturator in place.

Page 74

Operation and Frequently Used Functions

Performing surgical procedures

Figure 61: Holding the Autoguide Stab Incision Obturator in place

9. To avoid transmitting force on the entire system during hammering, make sure the thumb screw

™

on the Stealth Autoguide

Tracker is loosened before using a surgical hammer to anchor the

drill guide.

™

Tracker without misaligning the

surgical plan.

Figure 62: Locking the drill guide in position

11. Remove the Autoguide Tapping Tube and the obturator.

Page 75

Operation and Frequently Used Functions

Performing surgical procedures

Figure 63: Removing the Autoguide Tapping Tube and Autoguide Stab Incision Obturator

™

12. Check the Target Alignment Error on the StealthStation

screen to determine whether the

error is still within an acceptable range after hammering to anchor the drill guide.

If the Target Alignment Error is not acceptable, remove the drill guide from the Stealth Autoguide

™

Tracker and repeat the process of aligning to plan and introducing the drill guide,

obturator, and tapping tube.

13. Prepare the Midas Rex sEEG Bolt Placement Tool (DS1TD24) and the Legend

™

drill assembly: Install the Legend™ Depth Stop Twist Drill 2.4 mm

™

Depth Stop Attachment (ASDS01)

following the instructions for use that accompany the drill system.

Warning: Use only non-navigated Midas Rex™ Legend™ High Speed Drills together with the

surgical instruments of the Stealth Autoguide

™

system. Use of non-Medtronic drill systems

for creating cranial holes may result in a compromised surgical procedure.

14. Insert the Midas Rex

™

drill assembly in the drill guide and drill the hole in the skull following the

instructions for use that accompany the drill system. Use irrigation while drilling.

Warning: Do not apply high lateral forces while drilling a hole in the skull. Lateral forces while

drilling a hole in the skull may lead to deficient surgical procedure, such as elongated holes or mispositioned trajectory alignment.

Warning: Touching the brain or other tissue with a functioning drill may lead to severe patient or

user injury. The Stealth Autoguide

™

system and accessories are not intended for contact with

the central nervous system.

15. When finished, remove the Midas Rex

™

drill assembly.

16. Breach the dura.

17. When using an Ad-Tech bolt driver with a 4.0 mm diameter:

a. Insert the Autoguide sEEG 4.0 mm Reducing Tube into the Autoguide Stab Incision Drill

Guide.

b. Remove the cap from the anchor bolt and place it onto the bolt driver.

c. Insert the assembly (anchor bolt and driver) into the Autoguide sEEG 4.0 mm Reducing Tube.

When using an Ad-Tech bolt driver with a 2.4 mm diameter:

a. Place the Autoguide sEEG 2.4 mm Reducing Tube onto the bolt driver.

b. Remove the cap from the anchor bolt and place it onto the bolt driver.

c. Insert the assembly (anchor bolt, driver, and reducing tube) into the Autoguide Stab Incision

Drill Guide.

Page 76

Operation and Frequently Used Functions

Performing surgical procedures

18. Tighten the anchor bolt by turning the bolt driver the number of revolutions defined by the bolt manufacturer.

Figure 64: Tightening the anchor bolt

19. Remove the bolt driver, reducing tube, and the drill guide from the Stealth Autoguide

™

Tracker.

20. Calculate and set the depth of the electrode following the instructions for use that accompany the electrode.

21. Make sure there are no instruments remaining in the guiding bore of the Stealth Autoguide™ Tracker before proceeding.

22. Manually move the system to remove the Stealth Autoguide

™

Tracker from the work area.

Warning: Pay attention to the movement of the end effector when moving the system manually

or automatically. A collision with the patient or already placed surgical equipment may lead to patient injury, or a deficient surgical procedure.

23. Insert the electrode and lock the anchor bolt cap following the instructions for use that accompany the electrode and the anchor bolt.

Warning: Avoid a collision with implanted anchor bolts while manually removing the system from

the surgical area. A collision with already implanted anchor bolts may lead to patient injury or deficient surgical procedure.

Figure 65: Locking the anchor bolt cap

• If all electrodes have been placed, remove equipment as described in “Shutting down the system

and removing equipment” on page 84.

Page 77

Operation and Frequently Used Functions

Performing surgical procedures

™

• If more anchor bolts are to be placed, select a new plan on the StealthStation

system and confirm the selection of the new plan by pressing once on the joystick of the Autoguide Control Unit. Perform gross-positioning and alignment as necessary for the new plan.

• Repeat the steps in this section for each anchor bolt.

Page 78

Operation and Frequently Used Functions

Performing surgical procedures

Visualase™ bone anchor placement

The following equipment is needed for Visualase™ bone anchor placement:

Autoguide Visualase™ Drill Guide

Autoguide Visualase™ Obturator

Surgical hammer (not provided by Medtronic)

Autoguide Tapping Tube

Midas Rex™ Legend™ motor

Legend™ Depth Stop Twist Drill 3.2 mm Long Visualase™ Tool (DS1TD32L)

Legend™ Depth Stop Attachment (ASDS01)

Autoguide Visualase 1.7 mm Reducing Tube

Visualase™ Bone Anchor

(Equipment is not shown to scale.)

a. Prepare the Midas Rex

Long Visualase following the instructions for use that accompany the drill system.

b. Place the Autoguide Visualase™ Drill Guide over the drill assembly and power the drill

assembly to check for proper function and dissecting tool stability.

If the Legend the drill guide and replace it with a new drill guide.

Warning: Replace any device that appears to be damaged because a damaged device may

cause inaccuracy or patient harm.

2. Create a skin incision.

™

Depth Stop Twist Drill 3.2 mm Long Visualase™ Tool is unstable, dispose of

™

drill assembly: Install the Legend™ Depth Stop Twist Drill 3.2 mm

Tool (DS1TD32L) and the Legend™ Depth Stop Attachment (ASDS01)

™

Drill

Page 79

Operation and Frequently Used Functions

Figure 66: Skin incision

Performing surgical procedures

™

3. Insert the Autoguide Visualase

Drill Guide into the Stealth Autoguide™ Tracker and secure it by tightening the thumb screw. The drill guide must be slightly retracted to avoid touching the skin.

Warning: Ensure that the fixation screw on the Stealth Autoguide

™

Tracker is always locked after placing a surgical instrument into position. Failing to lock the fixation screw may result in a displacement of the surgical instrument and patient injury.

Figure 67: Autoguide Visualase

™

Drill Guide in the Stealth Autoguide™ Tracker

Page 80

Operation and Frequently Used Functions

Performing surgical procedures

4. Insert the Autoguide Visualase

5. Use a surgical hammer to temporarily anchor the obturator at the skull. The obturator will

provide guidance for the subsequent anchoring of the drill guide.

Warning: Use only enough force to achieve a stable connection with bone when anchoring

surgical tools on the skull. High forces when anchoring surgical tools may lead to injuries or inaccurate positioning.

™

Obturator into the drill guide until it touches soft tissue.

Figure 68: Autoguide Visualase™ Obturator in the drill guide

6. Unlock the drill guide and lower it until it makes contact with the skull. Enlarge the skin incision

if necessary.

Figure 69: Lowering the Autoguide Visualase

™

Drill Guide

7. Slide the Autoguide Tapping Tube over the obturator. Make sure the lower end of the Autoguide Tapping Tube is contacting the shoulder on the drill guide.

Page 81

Figure 70: Autoguide Tapping Tube over the obturator

8. Hold the obturator in place.

Operation and Frequently Used Functions

Performing surgical procedures

Figure 71: Holding the obturator in place

9. To avoid transmitting force on the entire system during hammering, make sure the thumb screw

on the Stealth Autoguide

™

Tracker is loosened before using a surgical hammer to anchor the

drill guide.

™

Tracker without misaligning the

surgical plan.

Page 82

Operation and Frequently Used Functions

Performing surgical procedures

Figure 72: Locking the drill guide in position

11. Remove the Autoguide Tapping Tube and the obturator.

Figure 73: Removing the Autoguide Tapping Tube and Autoguide Visualase™ Obturator

12. Check the Target Alignment Error on the StealthStation

™

screen to determine whether the

error is still within an acceptable range after hammering to anchor the drill guide.

If the Target Alignment Error is not acceptable, remove the drill guide from the Stealth Autoguide

™

Tracker and repeat the process of aligning to plan and introducing the drill guide,

obturator, and tapping tube.

13. Prepare the Midas Rex Long Visualase

™

drill assembly: Install the Legend™ Depth Stop Twist Drill 3.2 mm

Tool (DS1TD32L) and the Legend™ Depth Stop Attachment (ASDS01)

following the instructions for use that accompany the drill system.

Warning: Use only non-navigated Midas Rex

Surgical Instruments of the Stealth Autoguide

™

Legend™ High Speed Drills together with the

™

system. Use of non-Medtronic drill systems

for creating cranial holes may result in a compromised surgical procedure.

Page 83

Operation and Frequently Used Functions

Performing surgical procedures

™

14. Insert the Midas Rex

drill assembly in the Drill Guide and drill the hole in the skull following

the instructions for use that accompany the drill system. Use irrigation while drilling.

Warning: Do not apply high lateral forces while drilling a hole in the skull. Lateral forces while

drilling a hole in the skull may lead to deficient surgical procedure, such as elongated holes or mispositioned trajectory alignment.

Warning: Perform proper flushing, cooling, and irrigation during drilling to prevent entrance of

debris into the brain, temperature increase, and potential patient injuries due to those factors.

Warning: Touching the brain or other tissue with a functioning drill may lead to severe patient or

user injury. The Stealth Autoguide

™

system and accessories are not intended for contact with

the central nervous system.

15. When finished, remove the Midas Rex

™

drill assembly.

16. Breach the dura.

17. Remove the drill guide.

Figure 74: Removing the drill guide

™

18. Insert the Autoguide Visualase

1.7 mm Reducing Tube.

Figure 75: Inserting the reducing tube

19. Slightly open the cap of the Visualase™ Bone Anchor.

Page 84

Operation and Frequently Used Functions

Performing surgical procedures

20. Place the Visualase Tracker’s tube and the entry point.

Figure 76: Slightly opening the cap

™

Bone Anchor between the lower edge of the Stealth Autoguide™

21. Insert the Visualase Anchor until it almost touches the skull. The Visualase trajectory defined by the Stealth Autoguide Visualase

™

Bone Anchor to the skull, thus making sure it is aligned with the active surgical

™

Alignment Rod in the reducing tube and through the Visualase™ Bone

™

Tracker and direct the tightening of the

™

Alignment Rod will extend the

plan.

Warning: Do not touch the brain with the Visualase

into the drilled hole in the skull while fixating the Visualase with the Visualase

™

Rod may lead to patient injury. The Stealth Autoguide™ system and

™

Alignment Rod. Avoid inserting it too far

™

accessories are not intended for contact with the central nervous system.

Figure 77: Insert the Visualase

™

Alignment Rod

Bone Anchor. Touching the brain

™

22. Advance the Visualase

anchored, using care not to impair its alignment with the Visualase The number of revolutions to completely anchor the Visualase

Bone Anchor to the skull and anchor it by turning it manually until it is

™

Alignment Rod and hole.

™

Bone Anchor at the skull is available in the instructions for use that accompany the bone anchor (provided by the manufacturer).

Note: To check the alignment of the bone anchor, remove the Visualase

™

Alignment Rod and re-insert the rod back through the reducing tube and the bone anchor. There should be no friction as the rod slides through.

Page 85

Operation and Frequently Used Functions

™

Figure 78: Anchoring the Visualase

Bone Anchor

23. Remove the Visualase™ Alignment Rod and the reducing tube.

Performing surgical procedures

Page 86

Operation and Frequently Used Functions

Shutting down the system and removing equipment

1. Make sure there are no instruments remaining in the guiding bore of the Stealth Autoguide™

Tracker before proceeding.

2. Move the Autoguide Targeting Unit to the home position and power off the system by pressing the Power button on the Autoguide Control Unit until the screen turns dark.

3. Make sure that the weight of the Autoguide Targeting Unit is fully supported. Adjust the Autoguide Positioning Arm into a different position to move the Autoguide Targeting Unit away from the surgical area.

4. Close the wound (where applicable) and start undraping the patient.

5. Unmount the Stealth Autoguide

Autoguide Guiding Joints.

6. Remove the Autoguide Guiding Joints from the Autoguide Targeting Unit.

7. Remove the Autoguide Guiding Joints from the Autoguide Targeting Unit Sterile Drape.

8. Remove the drapes from the Autoguide Control Unit and the Autoguide Targeting Unit.

9. Dispose of the drapes.

Note: Confirm that the Autoguide Guiding Joints have been removed from the Autoguide

Targeting Unit Sterile Drape before disposing of the drapes.

10. Move the Stealth Autoguide™ Cart to the vicinity of the operating room table.

11. Remove the power plug from the electrical outlet and then disconnect the cables.

12. Remove the equipment from the patient head clamp and place the equipment in an appropriate

location for cleaning.

13. Remove the patient from the patient head clamp and from the operating room table.

14. Clean non-sterilizable equipment. Refer to “Non-sterilizable components” on page 87.

Warning: Do not autoclave the Autoguide Positioning Arm. It may degrade its holding capability

and result in patient injury.

™

Tracker and detach the Autoguide Guiding Inserts from the

Caution: Handle the equipment carefully. Severe damage of the equipment possible.

Caution: Precisely follow the equipment cleaning instructions in Chapter 4, Cleaning

Instructions. Ingress of liquid may cause severe damage of the electrical equipment or reduce its useful life.

Caution: Precisely follow the equipment cleaning instructions in “Cleaning the Autoguide

Targeting Unit, Autoguide Control Unit, Autoguide Strain Relief Box, and Autoguide Power and Network Unit” on page 88. Reduced visibility of visual indicators on the equipment may cause a delayed surgical workflow or the inability to recognize system warnings.

Caution: Precisely follow the equipment cleaning instructions in “Cleaning the Autoguide

Targeting Unit Cable Set, the Autoguide Control Unit Cable, and the Autoguide Power and Network Unit Cable” on page 89. Obstructed connectors may cause a prolonged surgical workflow.

Page 87

Operation and Frequently Used Functions

Shutting down the system and removing equipment

15. Store the non-sterilizable equipment on the rails and in the drawers of the Stealth Autoguide Cart.

Figure 79: Example equipment storage on the rails and in the drawers of the Stealth Autoguide

™

Cart

16. Store sterilizable equipment in the sterilization container and clean them. Refer to “Sterilizable components” on page 90.

Warning: Do not reprocess, resterilize, or reuse any single-use device. Attempts to reprocess

or resterilize a single-use device may be ineffective and may compromise its structural integrity. Any reuse creates a risk of contamination which could result in patient injury, illness, or death.

17. Transport the Stealth Autoguide location within the hospital.

Warning: Do not transport the Stealth Autoguide

The system may be damaged and such damage may not be realized until the system is being used for a subsequent patient. The system damage may lead to patient injury or a deficient surgical procedure.

Emergency shutdown

If you need to shut down the system quickly in an emergency, follow this procedure:

1. Press and hold the Power button on the Autoguide Control Unit until the screen turns dark.

2. After the system shuts down, remove the power plug from the electrical outlet.

™

system in the Stealth Autoguide™ Cart to a suitable storage

™

system outside of the hospital environment.

Equipment removal in case of emergency

If an emergency requires immediate access to the patient, remove all instruments from the endeffector (if present), fully support the weight of the targeting unit, unlock the Autoguide Positioning Arm, and reposition it away from the patient’s head.

Page 88

Operation and Frequently Used Functions

Shutting down the system and removing equipment

Page 89

4 Cleaning Instructions

Non-sterilizable components

General procedure

Caution: Do not allow fluid to enter any system enclosure. Do not spray liquids directly on the

system. This can lead to equipment damage. Disconnect from power and allow the system to dry if you suspect fluids may have entered any part of the unit.

1. Power down and unplug the system before performing cleaning or disinfection procedures.

2. Refer to Table 1 for compatible disinfectants and recommended chemistries. If a premoistened

wipe is not available, use a clean wipe moistened with the disinfectant. Do not over-saturate the wipe so much that liquid can enter openings in the parts to be cleaned.

3. Wipe the external surfaces with a clean wipe moistened with water or 70% isopropyl alcohol to remove the disinfectant residue on the system components. This helps maintain the appearance of the system components.

Table 1 : Compatible disinfectants

Disinfectant type Disinfectant level

Quaternary ammonium germicidal detergent solution Low level

Isopropyl alcohol (70%) Low level

Phenolic germicidal detergent solution Low level

Sodium hypochlorite (5.25% to 6.15%) Low level

Page 90

Cleaning Instructions

Non-sterilizable components

Cleaning the Autoguide Targeting Unit, Autoguide Control Unit, Autoguide Strain Relief Box, and Autoguide Power and Network Unit

1. Power down, unplug the system, and remove the sterile drapes before performing cleaning or disinfection procedures.

2. Unmount the Autoguide Targeting Unit from the Autoguide Positioning Arm.

3. Wipe and clean the exterior surfaces of the Autoguide Targeting Unit, Autoguide Control Unit,

Autoguide Strain Relief Box, and Autoguide Power and Network Unit with a moistened low-level disinfectant wipe per the wipe manufacturer’s instructions.

Do not damage the blue tape that seals the window opening of the Autoguide Targeting Unit.

4. If disinfection is desired, make sure that the surface to be disinfected remains in contact with the disinfectant for the specified contact time as directed by the disinfectant manufacturer.

• The contact time refers to the minimum amount of time the surface needs to remain visibly

wet.

• Use additional wipes, if needed, to maintain continuous contact time with the disinfectant.

5. Examine the surfaces for visible soil. If soil is present, repeat cleaning.

6. Wipe the external surfaces with a clean wipe moistened with water or 70% isopropyl alcohol to

remove disinfectant residue.

Cleaning the Autoguide Head Clamp Adapter and Autoguide Positioning Arm

Caution: Keep the ball joints of the Autoguide Positioning Arm clean. Dirty ball joints could seize,

resulting in a risk of delay during surgery.

1. If the Autoguide Targeting Unit is still mounted on the Autoguide Positioning Arm, unmount the Autoguide Targeting Unit.

2. Unmount the Autoguide Head Clamp Adapter and the Autoguide Positioning Arm and remove the drapes, if they are still in place.

3. Make sure that the ball joints of the Autoguide Positioning Arm are free from debris.

4. Wipe and clean the exterior surfaces of the Autoguide Head Clamp Adapter and the Autoguide

Positioning Arm with a moistened low-level disinfectant wipe per the wipe manufacturer’s instructions.

5. If disinfection is desired, make sure that the surface to be disinfected remains in contact with the disinfectant for the specified contact time as directed by the disinfectant manufacturer.

• The contact time refers to the minimum amount of time the surface needs to remain visibly

wet.

• Use additional wipes, if needed, to maintain continuous contact time with the disinfectant.

6. Examine the surfaces for visible soil. If soil is present, repeat cleaning.

7. Wipe the external surfaces with a clean wipe moistened with water or 70% isopropyl alcohol to

remove disinfectant residue.

Page 91

Cleaning Instructions

Non-sterilizable components

Cleaning the Autoguide Targeting Unit Cable Set, the Autoguide Control Unit Cable, and the Autoguide Power and Network Unit Cable

Caution: Do not allow liquid to enter the interior surfaces of the connectors.

1. Power down and unplug the system before performing cleaning or disinfection procedures.

2. Unplug external cables.

3. Clean the cable by wrapping a low-level disinfectant wipe completely around the cable, starting

at one connector.

4. If disinfection is desired, make sure that the surface to be disinfected remains in contact with the disinfectant for the specified contact time as directed by the disinfectant manufacturer.

• The contact time refers to the minimum amount of time the surface needs to remain visibly

wet.

• Use additional wipes, if needed, to maintain continuous contact time with the disinfectant.

5. Examine the surfaces for visible soil. If soil is present, repeat cleaning.

Ensure the cable pins are not obstructed by particles that could block, prevent, or compromise cable connections.

6. Wipe the external surfaces with a clean wipe moistened with water or 70% isopropyl alcohol to remove disinfectant residue.

Cleaning the power cord

1. Power down and unplug the system before performing cleaning or disinfection procedures.

2. Clean the power cable by wrapping a low-level disinfectant wipe completely around the cable.

3. Wipe the cable from the plug end toward the Autoguide Power and Network Unit’s end by

pulling the cable through the wipe. Stop when you reach the connector where the cable enters the Autoguide Power and Network Unit.

Ensure contact with the plug, bend relief, and cable. Do not wipe the metal prongs on the plug.

4. If disinfection is desired, make sure that the surface to be disinfected remains in contact with the disinfectant for the specified contact time as directed by the disinfectant manufacturer.

• The contact time refers to the minimum amount of time the surface needs to remain visibly

wet.

• Use additional wipes, if needed, to maintain continuous contact time with the disinfectant.

5. Examine the surfaces for visible soil. If soil is present, repeat cleaning.

Ensure the cable pins are not obstructed by particles that could block, prevent, or compromise cable connections.

6. Wipe the external surfaces with a clean wipe moistened with water or 70% isopropyl alcohol to remove disinfectant residue.

Page 92

Cleaning Instructions

Sterilizable components

Cleaning the Stealth Autoguide™ Cart

Refer to the instructions for use that accompany the Stealth Autoguide™ Cart.

Sterilizable components

The following instruments are sterilizable:

Common Instruments

• Stealth Autoguide™ Tracker (28248)

• Autoguide Tapping Tube (31527)

• Midas Rex™ Legend™ Depth Stop Attachment (ASDS01)

• Autoguide Lower Guiding Insert (28249)

• Autoguide Upper Guiding Insert (27586)

• Autoguide Guiding Joint (27584)

Biopsy / sEEG Instruments

• Autoguide Stab Incision Height Guide (27563)

• Autoguide Stab Incision Obturator (28340)

• Autoguide Stab Incision Drill Guide (28326)

• Autoguide Stab Biopsy 2.2 mm Reducing Tube (28330)

• Autoguide Burr Hole Drill Guide (28322)

• Autoguide Burr Hole 2.2 mm Reducing Tube (28334)

• Autoguide sEEG 2.4 mm Reducing Tube (28336)

• Autoguide sEEG 4.0 mm Reducing Tube (28328)

™

Visualase

• Autoguide Visualase™ Height Guide (27565)

• Autoguide Visualase™ Obturator (28338)

• Autoguide Visualase

• Autoguide Visualase™ 1.7 mm Reducing Tube (28332)

For cleaning and sterilization instructions refer to the Stealth Autoguide Cleaning and Sterilization instructions for use (9736152).

Instruments

™

Drill Guide (28324)

™

Reusable Devices

For cleaning of the Midas Rex for use that accompany the product.

™

Legend™ Depth Stop Attachment (ASDS01) refer to the instructions

Page 93

5 Troubleshooting

Refer to the table below for descriptions of error conditions.

Symptom Example display Reference section

An Error Code appears on the Autoguide Control Unit.

No bootup: The Autoguide Control Unit does not start up correctly.

“Autoguide Control Unit error codes” on page 94

“No bootup: The Autoguide Control Unit does not start up correctly” on page 98

Page 94

Troubleshooting

Symptom Example display Reference section

No communication with the StealthStation™ system.

Reachability information not shown.

“No communication with the StealthStation™ system” on page 99

“Autoguide Control Unit indicates that no reachability information can be shown” on page 101

The system does not execute automatic motion.

“The system does not execute automatic motion” on page 102

Page 95

Troubleshooting

General information on error notifications

Symptom Example display Reference section

The Autoguide Control Unit indicates that the surgical plan has changed.

The system is not aligning with the active surgical plan.

“Autoguide Control Unit indicates that the surgical plan has changed” on page 103

“The system is not aligning with the active surgical plan” on page 104

General information on error notifications

If the error or warning symbol on the Autoguide Targeting Unit lights up, refer to the Autoguide Control Unit screen for additional error indications.

Figure 80: Warning indication on the Autoguide Targeting Unit and the Autoguide Control Unit

Page 96

Troubleshooting

Autoguide Control Unit error codes

Refer to the table below for descriptions of error codes.

Symbol and ID Meaning Exception Type Required user action

General hardware or software error Auto recovery

Cabling fault Auto recovery

Hardware error: Motor encoder fault, defect in motor cabling or 5 V power supply

Hardware error: Linear encoder fault Stop exception If a restart does not solve the issue, contact

Hardware error: Inconsistency Stop exception If a restart does not solve the issue, contact

Potential collision Confirmable

Over temperature Stop exception Power off the system. Wait for cool down, and

exception

Stop exception If a restart does not solve the issue, contact

exception

Check cabling and wait for recovery. Also see the note at the end of this table.

technical support.

1. Release the Enable button and check the end-effector region for possible mechanical collisions.

2. Remove any obvious obstacle and reposition the Autoguide Targeting Unit.

3. Confirm the solution by pressing on the joystick.

then restart. If the error persists, contact technical support.

Deviation detected by redundant encoder system

Unexpected system movement Stop exception If a restart does not solve the issue, contact

Hardware error: Absolute position Stop exception If a restart does not solve the issue, contact

Error with the illuminated symbols on the Autoguide Targeting Unit

Stop exception If a restart does not solve the issue, contact

Confirmable exception

technical support.

Confirm via joystick and contact technical support. Also see the note at the end of this table.

Page 97

Troubleshooting

Autoguide Control Unit error codes

Symbol and ID Meaning Exception Type Required user action

Incorrect configuration data Stop exception If a restart does not solve the issue, contact

technical support.

Hardware error: Voltage fault Stop exception If a restart does not solve the issue, contact

Software and hardware do not match Stop exception If a restart does not solve the issue, contact

Cabling fault on the communication line to the Autoguide Control Unit

Cabling fault detected when an Enable button is pressed

Enable button is stuck Confirmable

Memory card error Confirmable

Software configuration error Stop exception If a restart does not solve the issue, contact

Auto recovery exception

exception

technical support.

Check cabling and wait for recovery. Also see the note at the end of this table.

Release button, if pressed, then confirm via the joystick. Otherwise, contact technical support.

Confirm via the joystick. Continue working and contact technical support if the error appears frequently.

technical support.

Joystick fault Stop exception If a restart does not solve the issue, contact

technical support.

Joystick out of center position Auto recovery

exception

Speed fault Confirmable

Firmware error Stop exception See symptom 2 in “No bootup: The Autoguide

Improper communication between the Autoguide Targeting Unit and the Autoguide Control Unit

exception

Auto recovery exception

Center the joystick, release the Enable button, and try again.

Confirm via the joystick. Select the intended speed mode and continue working. Contact technical support if the error appears frequently.

Control Unit does not start up correctly” on page 98.

Check cabling and wait for recovery. Also see the note at the end of this table.

Page 98

Troubleshooting

Autoguide Control Unit error codes

Symbol and ID Meaning Exception Type Required user action

Software incompatibility between the Autoguide Targeting Unit and the

Stop exception If a restart does not solve the issue, contact

technical support.

Autoguide Control Unit

Cabling fault: Re-powering from EMC silent mode failed

Enable button is pressed during bootup

Hardware fault: Motor is moving without the Enable button pressed

Configuration error on the Autoguide Targeting Unit

Hardware fault or mechanical movement was blocked

Autoguide Targeting Unit does not start properly: Configuration error or self test error

Autoguide Targeting Unit illuminated symbol status is not updated: Communication fault or hardware fault

Auto recovery exception

Auto recovery

Check cabling and wait for recovery. Also see the note at the end of this table.

Release the Enable button.

exception

Stop exception If a restart does not solve the issue, contact

technical support.

Stop exception If a restart does not solve the issue, contact

technical support.

Confirmable exception

Confirm via the joystick. Continue working and contact technical support if the error appears frequently.

Stop exception If a restart does not solve the issue, contact

technical support.

Stop exception If a restart does not solve the issue, contact

technical support.

The alignment procedure was aborted due to loss of communication with the StealthStation™ system

Confirmable exception

Confirm via the joystick that alignment was aborted. Check the network connection to the StealthStation

™

system and try again. Also

see the note at the end of this table.

Note: For cabling errors 0001, 0003, 0021, 0023, 0045, and 0061:

1. Make sure all cables are connected properly.

2. After the cables are connected correctly, the exception disappears automatically and the

system is ready for further operation.

If no obvious connection problem can be found, there may be an internal cable fault. If this notification is recurring after a restart, contact technical support and provide the error code next to the error symbol.

Page 99

Troubleshooting

Autoguide Control Unit error codes

Note: For display error 0016, the system is not able to show any information via the illuminated

symbols on the Autoguide Targeting Unit, but is still able to perform all other tasks. If you press the joystick to acknowledge the exception, this symbol on the Autoguide Control Unit permanently indicates the emergency behavior mode. Contact technical support for additional information.

Note: For cabling error 0075, the alignment procedure was aborted due to the lost communication

with the StealthStation

™

system.

1. Press the joystick to confirm the notification.

2. Check the origin of the communication loss. Refer to “No communication with the

StealthStation™ system” on page 99.

After the connection is restored, the alignment procedure can be initiated again.

Page 100

Troubleshooting

No bootup: The Autoguide Control Unit does not start up correctly

Symptom 1 Pressing the Power button at the Autoguide Control Unit does not start the system.

Cause Power supply issue.

Solution 1. Check system cabling, especially the power cable of the Autoguide Power

and Network Unit.

2. Check if the green power LED on the Autoguide Power and Network Unit is on.

3. Check if the white power LED on the Autoguide Control Unit is on.

Symptom 2 After startup, the Autoguide Control Unit

enters the bootloader mode and reports invalid firmware.

Cause There is no valid firmware installed on the system.

Solution No further operation is possible. If this notification is recurring after a restart of the

Autoguide Control Unit, contact technical support.

Symptom 3 The Autoguide Control Unit is beeping, the screen is black, and the red power LED

is flashing.

Cause The Autoguide Control Unit detected a self test error.

Solution No further operation is possible. If this notification is recurring after a restart of the

Autoguide Control Unit, contact technical support.