Read this manual completely before using this device.
Page 2
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.
Page 3
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
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
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
2
Page 5
8.Symbols
Explanation of symbols on package labeling 121
3
Page 6
4
Page 7
1Introduction
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.
5
Page 8
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
6
Page 9
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)
7
Page 10
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
8
Page 11
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.
9
Page 12
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
10
Page 13
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,
11
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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
125650 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.
12
Page 15
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
13
Page 16
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.)
14
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.)
Page 17
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).
15
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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
16
Page 19
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)
17
Page 20
Introduction
Contact information
World Wide Web
www.medtronic.com
E-mail
E-mail product enhancement requests to: dl.navsuggestions@medtronic.com
18
Page 21
2Product 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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Page 22
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
20
Page 23
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.
21
Page 24
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
22
Page 25
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.
23
Page 26
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 ScreenDetails
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.
26
Page 29
Product Description
User interface
SymbolDescriptionType of exception
Surgical plan has been changed
Confirmation is necessary.
Cable faultAuto recovery
Collision warningConfirmable
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 faultConfirmable
Autoguide Targeting Unit fault with the illuminated symbols
After confirmation, the system continues in emergency
behavior mode.
Over temperature faultStop exception
Hardware faultStop exception
Stop exception or
Auto recovery
Confirmable
Service neededStop exception
Speed faultConfirmable
SD card errorConfirmable
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Product Description
User interface
SymbolDescriptionType of exception
Configuration errorStop 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
Page 31
Product Description
User interface
Figure 9: System in EMC Silent mode
Stopping the EMC Silent mode
To stop the EMC Silent mode, press the Manual Mode or Automatic Mode button for at least
2 seconds. This activates either manual or automatic motion control mode.
Audio feedback
There are two kinds of audio feedback signals generated by the Autoguide Control Unit:
• Positive or negative feedback beep, with different tones. This beep is emitted during system
operation to indicate an action is allowed or denied.
Positive feedback signals have a higher pitch and are emitted to:
– Notify when the surgical plan has been changed
– Indicate that a movement to home position finished successfully
– Indicate that a movement to plan finished successfully
Negative feedback signals have a lower pitch and are emitted when pressing a button that is not
allowed or is not meaningful in the current context. For example, a low-pitched beep will sound
when pressing the Move to Home button when the system is not in Automatic mode.
• Periodic beeps for error conditions. Periodic beeping and the red blinking power LED on the
Autoguide Control Unit occur during a major system fault.
To stop the periodic beeps, power off the system.
29
Page 32
Product Description
User interface
30
Page 33
3Operation 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.
Page 35
Automatic mode
At the Autoguide Control Unit, press to change to Automatic mode.
Move to home position
At the Autoguide Control Unit, press and hold the Move to Home button and then press and hold
one of the Enable buttons (angulation or positioning ). The Autoguide Targeting Unit
automatically moves to the home position.
Operation and Frequently Used Functions
Moving the system
Figure 12: Activating movement to the home position
An active move-to-home sequence is indicated by a flashing symbol. This symbol turns to
and an audible beep indicates movement is finished and the Autoguide Targeting Unit has reached
the home position.
Temporarily releasing the Enable button pauses the movement. Pressing the Enable button again
resumes the motion.
Releasing the Move to Home button aborts the move to home procedure.
Automatic alignment to the surgical plan
Figure 13: Activating alignment to plan
Alignment to the surgical plan is only possible when all of the following conditions are achieved:
• There is a connection to the StealthStation
• The tracker tools are visible
• A surgical plan has been created in the StealthStation
reachable by the Autoguide Targeting Unit
™
system
™
Cranial software and the plan is
33
Page 36
Operation and Frequently Used Functions
Adjusting the speed of the Autoguide Targeting Unit’s movement
At the Autoguide Control Unit, press and hold the Move to Plan button and then press and hold
one of the Enable buttons (angulation or positioning ). The Autoguide Targeting Unit
automatically moves to align to the plan.
An active alignment sequence is indicated by a flashing symbol. This symbol turns to and an
audible beep indicates when movement is finished and the Autoguide Targeting Unit is successfully
aligned to the plan.
Temporarily releasing the Enable button pauses movement; pressing the Enable button again
resumes the motion.
Releasing the Move to Plan button aborts the alignment procedure.
During movement, if the Stealth Autoguide
system pauses motion and displays the flashing Visibility symbol . The system remains in a
waiting state until visibility is restored or the user releases the Move to Plan button .
™
Tracker or the patient reference frame is not visible, the
Adjusting the speed of the Autoguide Targeting Unit’s
movement
There are 2 speed modes, normal and slow.
After system startup, the Normal Speed mode is active by default. After you select one of the speed
settings, it will not change until you select a different speed setting or you restart the system.
Figure 14: Adjusting speed mode
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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Page 39
Operation and Frequently Used Functions
Figure 16: Connecting cables
Preparing the system
Mounting the system
1. Remove the Autoguide Head Clamp Adapter and coupling from the Stealth Autoguide™ Cart
and assemble them together. Mount the Autoguide Head Clamp Adapter to the patient head
clamp using the starburst connector.
Warning: Ensure that all mating connections at the Autoguide Head Clamp Adapter are fully
seated and have a snug fit. If the Autoguide Head Clamp Adapter is not mounted properly,
the patient may be injured.
1 Fixation plug for the Autoguide Targeting Unit Cable Set
2 Autoguide Strain Relief Box
3 Autoguide Power and Network Unit
A. To connect the power cord to the Autoguide Power and Network
Unit, rotate the plug clockwise until it clicks to the locked position.
B. To disconnect the power cord, slide the yellow locking mechanism
away from the Autoguide Power and Network Unit, rotate the power
cord plug counter clockwise, and disconnect the cord from the unit.
4 Autoguide Control Unit
37
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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.
39
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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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Page 45
Operation and Frequently Used Functions
Draping the system and inserting the end-effector
Wash and prepare the patient per hospital procedure. Then follow the steps in this section to drape
the system.
Draping the Autoguide Control Unit
1. Power on the Autoguide Control Unit.
2. Move the Autoguide Targeting Unit to the home position. At the Autoguide Control Unit, press
and hold the Move to Home button and then press and hold one of the Enable buttons
(angulation or positioning ). The Autoguide Targeting Unit automatically moves to the
home position.
Figure 24: Activating movement to the home position
Preparing the system
3. Make sure that the system successfully established a connection to the StealthStation
system.
When a connection is established, the Network symbol changes to the StealthStation
system Connection symbol .
4. Position the Autoguide Targeting Unit for subsequent sterile draping.
5. Drape the Autoguide Control Unit and place it on the sterile table:
a. Place your hands inside the drape and open it sufficiently to slide it over the Autoguide
Control Unit.
b. Slide the drape over the Autoguide Control Unit.
c. Pull the drape down completely and make sure the cable is covered.
d. Optionally, close the distal drape opening using the tape delivered with the drape.
™
6. Roll the Stealth Autoguide
Cart out of the vicinity of the operating room table.
™
™
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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.
Page 47
Operation and Frequently Used Functions
Preparing the system
Figure 26: Sliding the drape over the Autoguide Targeting Unit
6. Mount the Autoguide Guiding Joints to the Autoguide Targeting Unit.
Check for alignment of the white markings on the release buttons (see Figure 28). Then, make
sure the connection is secure by gently pushing and pulling the Autoguide Guiding Joints toward
and away from the Autoguide Targeting Unit. Make sure there is no interference with the drape.
Figure 27: Inserting the Guiding Joints into the Autoguide Targeting Unit
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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
46
Page 49
Operation and Frequently Used Functions
Preparing the system
• Make sure the smaller hole of the Autoguide Lower Guiding Insert is facing down in the
guiding joint.
Figure 29: Inserting the Guiding Inserts
47
Page 50
Operation and Frequently Used Functions
Preparing the system
2. For Brain Biopsy and sEEG cases, introduce the Autoguide Stab Incision Height Guide from
below into the Stealth Autoguide™ Tracker. The round tip must face up and the verification
pointer must face down. The Autoguide Stab Incision Height Guide clicks into place when its
retaining ring is fully seated in the Stealth Autoguide
™
Tracker.
For Visualase™ cases, introduce the Autoguide Visualase™ Height Guide from below into the
Stealth Autoguide
down. The Autoguide Visualase
seated in the Stealth Autoguide
™
Tracker. The round tip must face up and the verification pointer must face
™
Height Guide clicks into place when its retaining ring is fully
™
Tracker.
Figure 30: Inserting height guides
3. Fixate the selected height guide in the Stealth Autoguide™ Tracker by locking the thumb screw.
Figure 31: Fixating the height guide (for example, Height Guide, Stab Incision)
4. Verify the Stealth Autoguide
™
Tracker:
a. Place the verification tip in one of the divots of the Passive Cranial Reference Frame. Ensure
that the Stealth Autoguide
™
Tracker’s optical markers are facing toward the camera.
48
Page 51
Operation and Frequently Used Functions
b. Wait until a sound or an on-screen indicator on the StealthStation
successful verification.
Figure 32: Verifying the Stealth Autoguide
™
Tracker at the Passive Cranial Reference Frame
Preparing the system
™
system signifies a
5. Loosen the locking thumb screw and remove the height guide.
6. Flip the height guide over and reinsert it into the Stealth Autoguide™ Tracker, with the round tip
facing down.
7. Retract the top end (verification pointer) of the height guide out of the Stealth Autoguide
™
Tracker to adjust the set-up distance between the Autoguide Targeting Unit and the patient to
account for skin thickness. As the height guide is pulled back, each marking on the height guide
accounts for about 5 mm.
49
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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.
50
Page 53
Figure 34: Inserting the Stealth Autoguide
Operation and Frequently Used Functions
Preparing the system
™
Tracker in the guiding inserts
51
Page 54
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
™
54
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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:
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.
57
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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.
Page 61
Operation and Frequently Used Functions
Performing surgical procedures
Figure 43: Lowering the Autoguide Stab Incision Drill Guide
7. Slide the Autoguide Tapping Tube over the Autoguide Stab Incision Obturator. Make sure the
lower end of the Autoguide Tapping Tube is contacting the shoulder on the Autoguide Stab
Incision Drill Guide.
Figure 44: Autoguide Tapping Tube over the obturator
8. Use the index finger or the thumb to hold the Autoguide Stab Incision Obturator in place.
59
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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.
Page 63
Operation and Frequently Used Functions
Performing surgical procedures
Figure 47: Removing the Autoguide Tapping Tube and Autoguide Stab Incision Obturator
12. Check the Target Alignment Error on the StealthStation™ screen to determine whether the
error is still within an acceptable range after hammering to anchor the drill guide.
If the Target Alignment Error is not acceptable, remove the drill guide from the Stealth
Autoguide
™
Tracker and repeat the process of aligning to plan and introducing the drill guide,
obturator, and tapping tube.
13. Prepare the Midas Rex
Biopsy Tool (DS1TD32) and the Legend
™
drill assembly: Install the Legend™ Depth Stop Twist Drill 3.2 mm Stab
™
Depth Stop Attachment (ASDS01) following the
instructions for use that accompany the drill system.
Warning: Use only non-navigated Midas Rex™ Legend™ High Speed Drills together with the
surgical instruments of the Stealth Autoguide
™
system. Use of non-Medtronic drill systems
for creating cranial holes may result in a compromised surgical procedure.
14. Insert the Midas Rex
™
drill assembly in the drill guide and drill the hole in the skull following the
instructions for use that accompany the drill system. While drilling, flush with water.
Warning: Do not apply high lateral forces while drilling a hole in the skull. Lateral forces while
drilling a hole in the skull may lead to a deficient surgical procedure, such as elongated holes
or mispositioned trajectory alignment.
Warning: Perform proper flushing, cooling, and irrigation during drilling to prevent entrance of
debris into the brain, temperature increase, and potential patient injuries due to those factors.
Warning: Touching the brain or other tissue with a functioning drill may lead to severe patient or
user injury. The Stealth Autoguide
™
system and accessories are not intended for contact with
the central nervous system.
15. When finished, remove the Midas Rex
™
drill assembly.
16. Breach the dura.
17. Insert the Autoguide Stab Biopsy 2.2 mm Reducing Tube. The two pins on the reducing tube
must be placed into the slots on the drill guide completely, such that the pins rest on the
shoulder of the Stealth Autoguide
™
Tracker.
61
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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.
62
Page 65
Burr hole biopsy
The following equipment is needed for a burr hole biopsy procedure:
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.
63
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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.
64
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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.
65
Page 68
Operation and Frequently Used Functions
Performing surgical procedures
8. Insert the Midas Rex
instructions for use that accompany the drill system. Use irrigation while drilling.
Warning: Do not apply high lateral forces while drilling a hole in the skull. Lateral forces while
drilling a hole in the skull may lead to a deficient surgical procedure, such as elongated holes
or mispositioned trajectory alignment.
Warning: Perform proper flushing, cooling, and irrigation during drilling to prevent entrance of
debris into the brain, temperature increase, and potential patient injuries due to those factors.
™
drill assembly in the drill guide and drill the hole in the skull following the
Warning: Touching the brain or other tissue with a functioning drill may lead to severe patient or
user injury. The Stealth Autoguide
™
system and accessories are not intended for contact with
the central nervous system.
9. When finished, remove the Midas Rex
™
drill assembly.
10. Breach the dura.
11. Remove the Autoguide Burr Hole Drill Guide.
Figure 53: Removing the Autoguide Burr Hole Drill Guide
12. To ensure better accuracy, realign to the active surgical plan. If the accuracy displayed in the
StealthStation™ system monitor is considered adequate, proceed to the next step. Make sure
there are no instruments remaining in the guiding bore of the Stealth Autoguide
™
Tracker
before repeating the alignment.
66
Figure 54: Realigning to the active surgical plan
13. Insert the Autoguide Burr Hole 2.2 mm Reducing Tube.
Page 69
Operation and Frequently Used Functions
Performing surgical procedures
Figure 55: Insert the Autoguide Burr Hole 2.2 mm Reducing Tube
14. In the StealthStation™ Cranial software, lock the trajectory either by clicking [Lock Trajectory]
on the software screen or by pressing the StealthStation
™
system footswitch.
15. Prepare the Medtronic Navigated Biopsy Needle and set the depth stop at the correct position,
following the instructions for use that accompany the Navigated Biopsy Needle.
Warning: Refer to the tip stop point in the navigation software when setting the depth stop on
the biopsy needle. The software automatically calculates the tip stop point.The tip stop point
is the distance from the top surface of the reducing tube to the biopsy target.
16. Harvest tissue following instructions for use that accompany the Medtronic Navigated Biopsy
Needle.
Warning: Use only Medtronic Navigated Biopsy Needles with the Stealth Autoguide
™
system.
Use of other biopsy needles for tissue harvesting may result in a compromised surgical
procedure.
67
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Operation and Frequently Used Functions
Performing surgical procedures
sEEG bolt placement
The following equipment is needed for sEEG bolt placement:
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.
69
Page 72
Operation and Frequently Used Functions
Performing surgical procedures
Figure 57: Autoguide Stab Incision Drill Guide in the Stealth Autoguide
4. Insert the Autoguide Stab Incision Obturator in the drill guide and into the skin until it contacts
the skull.
Figure 58: Autoguide Stab Incision Obturator in the drill guide
™
Tracker
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.
Page 73
Operation and Frequently Used Functions
Performing surgical procedures
Figure 59: Lowering the Autoguide Stab Incision Drill Guide
7. Slide the Autoguide Tapping Tube over the Autoguide Stab Incision Obturator. Make sure the
lower end of the Autoguide Tapping Tube is contacting the shoulder of the drill guide.
Figure 60: Autoguide Tapping Tube over the obturator
8. Use the index finger or the thumb to hold the Autoguide Stab Incision Obturator in place.
71
Page 74
Operation and Frequently Used Functions
Performing surgical procedures
Figure 61: Holding the Autoguide Stab Incision Obturator in place
9. To avoid transmitting force on the entire system during hammering, make sure the thumb screw
™
on the Stealth Autoguide
Tracker is loosened before using a surgical hammer to anchor the
drill guide.
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.
Page 75
Operation and Frequently Used Functions
Performing surgical procedures
Figure 63: Removing the Autoguide Tapping Tube and Autoguide Stab Incision Obturator
™
12. Check the Target Alignment Error on the StealthStation
screen to determine whether the
error is still within an acceptable range after hammering to anchor the drill guide.
If the Target Alignment Error is not acceptable, remove the drill guide from the Stealth
Autoguide
™
Tracker and repeat the process of aligning to plan and introducing the drill guide,
obturator, and tapping tube.
13. Prepare the Midas Rex
sEEG Bolt Placement Tool (DS1TD24) and the Legend
™
drill assembly: Install the Legend™ Depth Stop Twist Drill 2.4 mm
™
Depth Stop Attachment (ASDS01)
following the instructions for use that accompany the drill system.
Warning: Use only non-navigated Midas Rex™ Legend™ High Speed Drills together with the
surgical instruments of the Stealth Autoguide
™
system. Use of non-Medtronic drill systems
for creating cranial holes may result in a compromised surgical procedure.
14. Insert the Midas Rex
™
drill assembly in the drill guide and drill the hole in the skull following the
instructions for use that accompany the drill system. Use irrigation while drilling.
Warning: Do not apply high lateral forces while drilling a hole in the skull. Lateral forces while
drilling a hole in the skull may lead to deficient surgical procedure, such as elongated holes
or mispositioned trajectory alignment.
Warning: Touching the brain or other tissue with a functioning drill may lead to severe patient or
user injury. The Stealth Autoguide
™
system and accessories are not intended for contact with
the central nervous system.
15. When finished, remove the Midas Rex
™
drill assembly.
16. Breach the dura.
17. When using an Ad-Tech bolt driver with a 4.0 mm diameter:
a. Insert the Autoguide sEEG 4.0 mm Reducing Tube into the Autoguide Stab Incision Drill
Guide.
b. Remove the cap from the anchor bolt and place it onto the bolt driver.
c. Insert the assembly (anchor bolt and driver) into the Autoguide sEEG 4.0 mm Reducing Tube.
When using an Ad-Tech bolt driver with a 2.4 mm diameter:
a. Place the Autoguide sEEG 2.4 mm Reducing Tube onto the bolt driver.
b. Remove the cap from the anchor bolt and place it onto the bolt driver.
c. Insert the assembly (anchor bolt, driver, and reducing tube) into the Autoguide Stab Incision
Drill Guide.
73
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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.
Page 77
Operation and Frequently Used Functions
Performing surgical procedures
™
• If more anchor bolts are to be placed, select a new plan on the StealthStation
system and
confirm the selection of the new plan by pressing once on the joystick of the Autoguide Control
Unit. Perform gross-positioning and alignment as necessary for the new plan.
• Repeat the steps in this section for each anchor bolt.
75
Page 78
Operation and Frequently Used Functions
Performing surgical procedures
Visualase™ bone anchor placement
The following equipment is needed for Visualase™ bone anchor placement:
Autoguide Visualase™ Drill Guide
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
76
Page 79
Operation and Frequently Used Functions
Figure 66: Skin incision
Performing surgical procedures
™
3. Insert the Autoguide Visualase
Drill Guide into the Stealth Autoguide™ Tracker and secure it
by tightening the thumb screw. The drill guide must be slightly retracted to avoid touching the
skin.
Warning: Ensure that the fixation screw on the Stealth Autoguide
™
Tracker is always locked
after placing a surgical instrument into position. Failing to lock the fixation screw may result
in a displacement of the surgical instrument and patient injury.
Figure 67: Autoguide Visualase
™
Drill Guide in the Stealth Autoguide™ Tracker
77
Page 80
Operation and Frequently Used Functions
Performing surgical procedures
4. Insert the Autoguide Visualase
5. Use a surgical hammer to temporarily anchor the obturator at the skull. The obturator will
provide guidance for the subsequent anchoring of the drill guide.
Warning: Use only enough force to achieve a stable connection with bone when anchoring
surgical tools on the skull. High forces when anchoring surgical tools may lead to injuries or
inaccurate positioning.
™
Obturator into the drill guide until it touches soft tissue.
Figure 68: Autoguide Visualase™ Obturator in the drill guide
6. Unlock the drill guide and lower it until it makes contact with the skull. Enlarge the skin incision
if necessary.
Figure 69: Lowering the Autoguide Visualase
™
Drill Guide
7. Slide the Autoguide Tapping Tube over the obturator. Make sure the lower end of the Autoguide
Tapping Tube is contacting the shoulder on the drill guide.
78
Page 81
Figure 70: Autoguide Tapping Tube over the obturator
8. Hold the obturator in place.
Operation and Frequently Used Functions
Performing surgical procedures
Figure 71: Holding the obturator in place
9. To avoid transmitting force on the entire system during hammering, make sure the thumb screw
on the Stealth Autoguide
™
Tracker is loosened before using a surgical hammer to anchor the
drill guide.
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.
79
Page 82
Operation and Frequently Used Functions
Performing surgical procedures
Figure 72: Locking the drill guide in position
11. Remove the Autoguide Tapping Tube and the obturator.
Figure 73: Removing the Autoguide Tapping Tube and Autoguide Visualase™ Obturator
12. Check the Target Alignment Error on the StealthStation
™
screen to determine whether the
error is still within an acceptable range after hammering to anchor the drill guide.
If the Target Alignment Error is not acceptable, remove the drill guide from the Stealth
Autoguide
™
Tracker and repeat the process of aligning to plan and introducing the drill guide,
obturator, and tapping tube.
13. Prepare the Midas Rex
Long Visualase
™
™
drill assembly: Install the Legend™ Depth Stop Twist Drill 3.2 mm
Tool (DS1TD32L) and the Legend™ Depth Stop Attachment (ASDS01)
following the instructions for use that accompany the drill system.
Warning: Use only non-navigated Midas Rex
Surgical Instruments of the Stealth Autoguide
™
Legend™ High Speed Drills together with the
™
system. Use of non-Medtronic drill systems
for creating cranial holes may result in a compromised surgical procedure.
80
Page 83
Operation and Frequently Used Functions
Performing surgical procedures
™
14. Insert the Midas Rex
drill assembly in the Drill Guide and drill the hole in the skull following
the instructions for use that accompany the drill system. Use irrigation while drilling.
Warning: Do not apply high lateral forces while drilling a hole in the skull. Lateral forces while
drilling a hole in the skull may lead to deficient surgical procedure, such as elongated holes
or mispositioned trajectory alignment.
Warning: Perform proper flushing, cooling, and irrigation during drilling to prevent entrance of
debris into the brain, temperature increase, and potential patient injuries due to those factors.
Warning: Touching the brain or other tissue with a functioning drill may lead to severe patient or
user injury. The Stealth Autoguide
™
system and accessories are not intended for contact with
the central nervous system.
15. When finished, remove the Midas Rex
™
drill assembly.
16. Breach the dura.
17. Remove the drill guide.
Figure 74: Removing the drill guide
™
18. Insert the Autoguide Visualase
1.7 mm Reducing Tube.
Figure 75: Inserting the reducing tube
19. Slightly open the cap of the Visualase™ Bone Anchor.
81
Page 84
Operation and Frequently Used Functions
Performing surgical procedures
20. Place the Visualase
Tracker’s tube and the entry point.
Figure 76: Slightly opening the cap
™
Bone Anchor between the lower edge of the Stealth Autoguide™
21. Insert the Visualase
Anchor until it almost touches the skull. The Visualase
trajectory defined by the Stealth Autoguide
Visualase
™
Bone Anchor to the skull, thus making sure it is aligned with the active surgical
™
Alignment Rod in the reducing tube and through the Visualase™ Bone
™
Tracker and direct the tightening of the
™
Alignment Rod will extend the
plan.
Warning: Do not touch the brain with the Visualase
into the drilled hole in the skull while fixating the Visualase
with the Visualase
™
Rod may lead to patient injury. The Stealth Autoguide™ system and
™
Alignment Rod. Avoid inserting it too far
™
accessories are not intended for contact with the central nervous system.
Figure 77: Insert the Visualase
™
Alignment Rod
Bone Anchor. Touching the brain
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.
Page 85
Operation and Frequently Used Functions
™
Figure 78: Anchoring the Visualase
Bone Anchor
23. Remove the Visualase™ Alignment Rod and the reducing tube.
Performing surgical procedures
83
Page 86
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.
Page 87
Operation and Frequently Used Functions
Shutting down the system and removing equipment
15. Store the non-sterilizable equipment on the rails and in the drawers of the Stealth Autoguide
Cart.
Figure 79: Example equipment storage on the rails and in the drawers of the Stealth Autoguide
™
™
Cart
16. Store sterilizable equipment in the sterilization container and clean them. Refer to “Sterilizable
components” on page 90.
Warning: Do not reprocess, resterilize, or reuse any single-use device. Attempts to reprocess
or resterilize a single-use device may be ineffective and may compromise its structural
integrity. Any reuse creates a risk of contamination which could result in patient injury, illness,
or death.
17. Transport the Stealth Autoguide
location within the hospital.
Warning: Do not transport the Stealth Autoguide
The system may be damaged and such damage may not be realized until the system is being
used for a subsequent patient. The system damage may lead to patient injury or a deficient
surgical procedure.
Emergency shutdown
If you need to shut down the system quickly in an emergency, follow this procedure:
1. Press and hold the Power button on the Autoguide Control Unit until the screen turns dark.
2. After the system shuts down, remove the power plug from the electrical outlet.
™
system in the Stealth Autoguide™ Cart to a suitable storage
™
system outside of the hospital environment.
Equipment removal in case of emergency
If an emergency requires immediate access to the patient, remove all instruments from the endeffector (if present), fully support the weight of the targeting unit, unlock the Autoguide Positioning
Arm, and reposition it away from the patient’s head.
85
Page 88
Operation and Frequently Used Functions
Shutting down the system and removing equipment
86
Page 89
4Cleaning 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.
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.
89
Page 92
Cleaning Instructions
Sterilizable components
Cleaning the Stealth Autoguide™ Cart
Refer to the instructions for use that accompany the Stealth Autoguide™ Cart.
• 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
5Troubleshooting
Refer to the table below for descriptions of error conditions.
SymptomExample displayReference 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
91
Page 94
Troubleshooting
SymptomExample displayReference 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
92
Page 95
Troubleshooting
General information on error notifications
SymptomExample displayReference 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
93
Page 96
Troubleshooting
Autoguide Control Unit error codes
Autoguide Control Unit error codes
Refer to the table below for descriptions of error codes.
Symbol and IDMeaningException TypeRequired user action
General hardware or software errorAuto recovery
Cabling faultAuto recovery
Hardware error: Motor encoder fault,
defect in motor cabling or 5 V power
supply
Hardware error: Linear encoder fault Stop exceptionIf a restart does not solve the issue, contact
Hardware error: InconsistencyStop exceptionIf a restart does not solve the issue, contact
Potential collisionConfirmable
Over temperatureStop exceptionPower off the system. Wait for cool down, and
exception
exception
Stop exceptionIf 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 movementStop exceptionIf a restart does not solve the issue, contact
Hardware error: Absolute positionStop exceptionIf a restart does not solve the issue, contact
Error with the illuminated symbols on
the Autoguide Targeting Unit
Stop exceptionIf 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 IDMeaningException TypeRequired user action
Incorrect configuration dataStop exceptionIf a restart does not solve the issue, contact
technical support.
Hardware error: Voltage faultStop exceptionIf a restart does not solve the issue, contact
Software and hardware do not match Stop exceptionIf 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 stuckConfirmable
Memory card errorConfirmable
Software configuration errorStop exceptionIf 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 faultStop exceptionIf a restart does not solve the issue, contact
technical support.
Joystick out of center positionAuto recovery
exception
Speed faultConfirmable
Firmware errorStop exceptionSee 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.
95
Page 98
Troubleshooting
Autoguide Control Unit error codes
Symbol and IDMeaningException TypeRequired user action
Software incompatibility between the
Autoguide Targeting Unit and the
Stop exceptionIf 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 exceptionIf a restart does not solve the issue, contact
technical support.
Stop exceptionIf 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 exceptionIf a restart does not solve the issue, contact
technical support.
Stop exceptionIf 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.
97
Page 100
Troubleshooting
No bootup: The Autoguide Control Unit does not start up correctly
No bootup: The Autoguide Control Unit does not start up
correctly
Symptom 1Pressing the Power button at the Autoguide Control Unit does not start the system.
CausePower supply issue.
Solution1. 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 2After startup, the Autoguide Control Unit
enters the bootloader mode and reports
invalid firmware.
CauseThere is no valid firmware installed on the system.
SolutionNo further operation is possible. If this notification is recurring after a restart of the
Autoguide Control Unit, contact technical support.
Symptom 3The Autoguide Control Unit is beeping, the screen is black, and the red power LED
is flashing.
CauseThe Autoguide Control Unit detected a self test error.
SolutionNo further operation is possible. If this notification is recurring after a restart of the
Autoguide Control Unit, contact technical support.
98
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