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
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
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
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
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:
procedures. Potential clinical benefits are to facilitate navigated
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

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
thermal laser ablation therapies.
System
Legend™ Depth Stop
Support the placement of Visualase
Bone Anchors in Visualase™ procedures
Please keep in mind that establishing a connection between the Stealth Autoguide StealthStation
System is considered as configuring a system, per IEC60601-1.
System and the
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Description of the Stealth Autoguide™ System

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

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

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.
System should be used only by qualified medical professionals who are
S8 Systems running Cranial software
System is compatible with the Autoguide Targeting Unit Sterile
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.
system. Log files within the system will be maintained to verify
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.
system, including cables specified by the manufacturer. Otherwise, degradation of
system must only be established directly,
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Introduction

Stealth Autoguide™ system details

Stealth Autoguide™ system details
This section introduces the core system and its components with their main functions.
Figure 2: The core system and its components
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.
Tracker: Holds and guides surgical instruments. The user can
Tracker by detecting the spatial location of the passive optical spheres
system infrared camera tracks the position and orientation of
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.
Tracker. The Autoguide Upper Guiding Insert is sterilizable.
Tracker. Includes a knob screw for fixation of the Stealth Autoguide™ Tracker. The
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
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.
system.
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)
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
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.
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).
Depth Stop Twist Drill 2.4 mm sEEG Bolt Placement Tool
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.)
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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
Legend™ Depth Stop Attachment (ASDS01) while creating a cranial access
Tool (DS1TD32L).
9 28338 Autoguide Visualase
of the Autoguide Visualase
Drill Guide is a tube with sharp teeth on its distal end. The drill
Depth Stop Twist Drill 3.2 mm Long
Obturator is a rod with a sharp point used to aid in anchoring
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
Drill Guide. After the Autoguide Visualase™ Drill Guide has been adequately
1.7 mm Reducing Tube consists of a 1.7 mm inner-diameter
Alignment Rod during the placement of a Visualase™ Bone Anchor.
Obturator is removed.
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
Tracker.
Tracker.
Height Guide is similar to the Autoguide Stab Incision Height
Bone Anchor fits under the Autoguide
Height Guide also provides the verification tip for the
Tracker is
Tracker
q 31527 Autoguide Tapping Tube allows the obturator to remain securely in place while the
user hammers the Autoguide Visualase
Drill Guide (28324) and the Autoguide Stab Incision
Drill Guide (28326).
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Introduction

Scope of this manual

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

Related documents

For navigation software instructions, refer to the specific software’s instructions for use. For components that interface with the StealthStation frames, or intraoperative imaging systems, refer to the component’s instructions for use.
For Visualase Guided Laser Ablation System and its components.
For Drill System instructions, refer to the instructions for use that accompany the drill system and the Midas Rex
For cleaning and sterilization instructions of the surgical accessories provided with the Stealth Autoguide sterilization container. For cleaning of the Midas Rex instructions for use that accompany the product.
For information about the Stealth Autoguide instructions for use that accompany the cart.
If issues arise related to those individual systems, refer also to the guidance found in the instructions for use provided by the systems’ manufacturer.
instructions, refer to the instructions for use that accompany the Visualase™ MRI-
Legend™ Depth Stop Attachment and Tools.
System, refer to the instructions for use (part number 9736152) that accompany the
System.
system, such as instruments, patient reference
Legend™ Depth Stop Attachment, refer to the
Cart, including cleaning instructions, refer to the
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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
system
Product Description
User interface
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.
system.
system is successfully established.
24
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.
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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.
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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
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Product Description
User interface
Symbol Description Type of exception
Configuration error Stop exception
Communication with the StealthStation during movement to plan
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
28
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.
system. Manual or automatic
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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.
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Product Description
User interface
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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.
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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.
32
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.
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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
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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
34
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,
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.
system must only be established
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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.
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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
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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.
38
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.
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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.
system and contact
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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.
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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.
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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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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
44
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.
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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
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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
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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
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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.
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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.
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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.
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Figure 34: Inserting the Stealth Autoguide
Operation and Frequently Used Functions
Preparing the system
Tracker in the guiding inserts
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Operation and Frequently Used Functions

Gross-positioning and alignment

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
52
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.
53
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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
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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.
55
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Operation and Frequently Used Functions

Performing surgical procedures

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:
56
Autoguide Stab Incision Drill Guide
1
Autoguide Stab Incision Obturator
2
Autoguide Tapping Tube
3
Autoguide Stab Biopsy 2.2 mm Reducing Tube
4
Surgical hammer (not provided by Medtronic)
5
Legend™ Depth Stop Twist Drill 3.2 mm Stab Biopsy Tool (DS1TD32)
6
Legend™ Depth Stop Attachment (ASDS01)
7
Midas Rex™ Legend™ motor
8
Medtronic Navigated Biopsy Needle
9
(Equipment is not shown to scale.)
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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.
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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
58
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.
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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.
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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
60
11. Remove the Autoguide Tapping Tube and Autoguide Stab Incision Obturator.
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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.
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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.
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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
1
Surgical hammer (not provided by Medtronic)
2
Legend™ Depth Stop Twist Drill 7.5 mm Burr Hole Biopsy Tool (DS1TD75)
3
Legend™ Depth Stop Attachment (ASDS01)
4
Midas Rex™ Legend™ motor
5
Autoguide Burr Hole 2.2 mm Reducing Tube
6
Medtronic Navigated Biopsy Needle
7
(Equipment is not shown to scale.)
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. Cut the skin and muscle with a scalpel and retract it to clear access to bone.
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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.
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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.
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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.
66
Figure 54: Realigning to the active surgical plan
13. Insert the Autoguide Burr Hole 2.2 mm Reducing Tube.
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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.
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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
1
Autoguide Stab Incision Obturator
2
Surgical hammer (not provided by Medtronic)
3
Autoguide Tapping Tube
4
Legend™ Depth Stop Attachment (ASDS01)
5
Midas Rex™ Legend™ motor
6
Legend™ Depth Stop Twist Drill 2.4 mm sEEG Bolt Placement Tool (DS1TD24)
7
Ad-Tech bolt driver 4.0 mm or 2.4 mm (Ad-Tech bolt drivers are not provided by
8
Medtronic.)
Autoguide sEEG 2.4 mm Reducing Tube
9
Autoguide sEEG 4.0 mm Reducing Tube
0
2.4 mm or 4.0 mm anchor bolt
-
68
(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
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 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.
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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
70
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.
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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.
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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.
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 62: Locking the drill guide in position
72
11. Remove the Autoguide Tapping Tube and the obturator.
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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.
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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
74
If all electrodes have been placed, remove equipment as described in “Shutting down the system
and removing equipment” on page 84.
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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.
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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
1
Autoguide Visualase™ Obturator
2
Surgical hammer (not provided by Medtronic)
3
Autoguide Tapping Tube
4
Midas Rex™ Legend™ motor
5
Legend™ Depth Stop Twist Drill 3.2 mm Long Visualase™ Tool (DS1TD32L)
6
Legend™ Depth Stop Attachment (ASDS01)
7
Autoguide Visualase 1.7 mm Reducing Tube
8
Visualase™ Bone Anchor
9
(Equipment is not shown to scale.)
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. Before using the Autoguide Visualase Guide (28324), follow these steps:
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
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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
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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.
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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.
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.
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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.
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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.
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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
82
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.
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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
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Operation and Frequently Used Functions

Shutting down the system and removing equipment

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
84
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.
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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.
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Operation and Frequently Used Functions
Shutting down the system and removing equipment
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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
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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.
88
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.
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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
90
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
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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
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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
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Troubleshooting

Autoguide Control Unit error codes

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
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.
Check cabling and wait for recovery. Also see the note at the end of this table.
technical support.
technical support.
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.
94
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.
technical support.
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
Auto recovery exception
exception
exception
technical support.
technical support.
Check cabling and wait for recovery. Also see the note at the end of this table.
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.
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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.
96
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.
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Troubleshooting

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

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.
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