Medtronic 29631 Instructions for Use

Stealth Autoguide™ System Manual

Read this manual completely before using this device.

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

The information contained in this document is accurate at time of publication. Medtronic reserves the right to make changes to the product described in this manual without notice and without incorporating those changes to products already sold.

1.Introduction

Intended use 5 Indications for use 5 Clinical benefits 5 Contraindications 5

Operating Principle 6 Description of the Stealth Autoguide™ System 7 Navigational accuracy 8

System installation 8 User profiles 8 Compatibility 8 Side effects 9 Potential complications 9 Material composition 9 Conventions 9 Warnings and precautions 9

Warnings 9 Precautions 11

Stealth Autoguide

Surgical Instruments 13 Scope of this manual 16 Related documents 16 Contact information 17

Telephone 17

Mailing address 17

Medtronic E.C. authorized representative 17

Australia 17

World Wide Web 18

E-mail 18

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system details 12

2.Product Description

User interface 19

Autoguide Targeting Unit 19

Autoguide Control Unit 20

3.Operation and Frequently Used Functions

Starting the system 31 Stopping the system 31 Moving the system 31

Manual mode 32

Automatic mode 33 Adjusting the speed of the Autoguide Targeting Unit’s movement 34

Preparing the system 35

Connecting the cables 35

Mounting the system 37

Draping the system and inserting the end-effector 43

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

Detecting deviations 54 Performing surgical procedures 56

Stab incision biopsy 56

Burr hole biopsy 63

sEEG bolt placement 68 Visualase™ bone anchor placement 76

Shutting down the system and removing equipment 84

Emergency shutdown 85 Equipment removal in case of emergency 85

4.Cleaning Instructions

Non-sterilizable components 87

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

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

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

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Cleaning the Stealth Autoguide

Cart 90

Sterilizable components 90

5.Troubleshooting

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

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system 99

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

Troubleshooting mechanical components, cables, and drapes 106

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Stealth Autoguide

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

6.Service

Corrective maintenance 111 Recommended maintenance 111 Spare parts 112 Disposal 112

7.Specifications

System classifications 113

U.S. Food and Drug Administration classification 113

Electromagnetic emissions and immunity declarations 114 Warranty 115 Technical data 115

Essential performance 115

Intended environment for use 116 Cable specifications 116

Technical specifications 117

8.Symbols

Explanation of symbols on package labeling 121

1 Introduction

Intended use

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

Indications for use

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

Clinical benefits

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

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procedures. Potential clinical benefits are to facilitate navigated

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System potentially confer

• Increase in accuracy of the procedure

• Reduction in surgical or operating room time

Contraindications

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

Introduction

Operating Principle

The Stealth Autoguide™ System has the following operating principle, in order to support stab incision biopsies, burr hole biopsies, the placement of sEEG bolts for depth electrodes, and the placement of bone anchors for Visualase

• Provide a mechanical connection to the patient head clamp

• Provide a tracker for continuous position tracking by a StealthStation

• Read navigation data from a StealthStation™ System

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

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

• Support the creation of a cranial access hole with the use of Midas Rex

Attachment and Tools

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

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

placement of Ad-Tech sEEG bolts

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thermal laser ablation therapies.

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System

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Legend™ Depth Stop

• Support the placement of Visualase

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Bone Anchors in Visualase™ procedures

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

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

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System and the

Description of the Stealth Autoguide™ System

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

Figure 1: Stealth Autoguide

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System. The Autoguide Power and Network Unit

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System components

Introduction

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system and to

1 Core system: For details refer to “Stealth Autoguide

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system details” on page 12.

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

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

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

Introduction

Navigational accuracy

Under representative worst-case configuration, the Stealth Autoguide™ System used in conjunction with the StealthStation performance in 3D positional accuracy with a mean error ≤2.0 mm and in trajectory angle accuracy with a mean error ≤2.0 degrees. The positional error is defined as the Euclidean distance from target to instrument tip at final point of insertion. The trajectory angle error is the angle between the planned surgical trajectory and trajectory of the neurosurgical instrument at final point of insertion. Depending on the surgical procedure and the particular neurosurgical instruments used, the resulting navigational accuracy may be negatively impacted.

This performance was determined using an anatomically representative phantom and utilizing a subset of system components and features that represent the worst-case combination of all potential system components in a clinically relevant workflow. The test configuration included CT images with slice spacing and thickness of 1.25 mm and T2-weighted MR images with slice spacing and thickness of 1.0 mm.

System installation

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

User profiles

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System with StealthStation™ Cranial software has demonstrated

The intended user profile for the Stealth Autoguide™ System is operating room staff during the procedure (including surgeons, nurses, and clinical support specialists) and the sterile processing department personnel after the procedure. The users should be familiar with sterile workflows and usage of neurosurgical navigation equipment.

The Stealth Autoguide thoroughly trained in use of the system.

The intended patient population for the system is patients for whom stereotactic image guided surgery is appropriate.

Compatibility

The Stealth Autoguide™ System is compatible with StealthStation™ S7™ and i7™ Systems running Cranial software version 3.1.2 or later and with StealthStation version 1.2.0 or later.

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

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

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System should be used only by qualified medical professionals who are

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S8 Systems running Cranial software

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System is compatible with the Autoguide Targeting Unit Sterile

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

reusable devices, use the Stealth

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.

Introduction

Warnings and precautions

Warning:

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

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

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

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

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

The power cord may not be extended by an extension cord since this increases the

resistance of the protective earth and may result in electric shock. countries with dedicated medical grade power outlets, connection of the system is only allowed to a power outlet that provides a protective earth connection marked as “MEDICAL GRADE” or “HOSPITAL GRADE”.

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

mains with protective earth.

monopolar or bipolar needles or forceps, together with the system. Hazardous voltage may be induced to the system. Risk of electrical shock or thermal injuries.

needles or forceps, with maximum output voltages higher than 6 kV (peak-to-peak) together with the system. Hazardous voltage may be induced to the system. Risk of electrical arcs, electrical shocks, or thermal injuries.

the Autoguide Sterile Drapes:

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

• Touching unsterile surfaces with the drape

For the U.S.A. and other

• Close proximity of sharp instruments to the drape

Warning: System status information may not be available on the Autoguide Control Unit due to a

display failure. In this case, consult the StealthStation alignment information and the illuminated symbols on the Autoguide Targeting Unit to understand if any system error exists. Failure to follow these instructions may result in a risk of patient injury or a compromised surgical procedure.

Warning: The use of instrumentation, interfaces, and sterile drapes other than stated compatible

instruments, interfacing devices, and sterile drapes may lead to loss of accuracy, patient injury, or both.

Warning: The use of system components beyond their useful life may lead to patient injury.

Warning: The repair or modification of the system components or surgical instruments by anyone

other than qualified service personnel may compromise the product’s ability to perform effectively and void the equipment warranty.

Warning: Reusable devices are designed for re-use and are supplied in non-sterile condition. Clean

and sterilize devices before every use in accordance with specified instructions.

Warning: Connecting the system to non-approved IT networks and other equipment can result in

previously unidentified risks to patients, operators, or third parties. The system must only be connected to a StealthStation proper setup. The responsibility for the identification, analysis, evaluation, and control of risks associated with connecting the system to a non-approved IT network resides with the individuals performing the connection.

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

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system display for current trajectory

Precautions

Introduction

Warnings and precautions

Warning: Changes to the IT network can introduce new risks to the product that require additional

analysis. These changes encompass changes in network configuration, connection of additional items, disconnection of items, update of equipment, or upgrade of equipment. Log files within the system will be maintained to verify proper setup. Individuals implementing changes on the IT network are responsible for the identification, analysis, evaluation, and control of risks associated with the changes.

Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

Caution: Exceeding the maximum length of any cables may impact the electromagnetic

performance and compliance (immunity or emission) of the system.

Caution: The network connection to the StealthStation

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

Caution: Portable RF communications equipment (including peripherals such as antenna cables

and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Stealth Autoguide the performance of this equipment could result.

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

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system must only be established directly,

Introduction

Stealth Autoguide™ system details

This section introduces the core system and its components with their main functions.

Figure 2: The core system and its components

1 25650 Autoguide Targeting Unit: Receives commands and power from the Autoguide

Control Unit and moves to establish a fixed trajectory for surgical instruments. The Autoguide Targeting Unit is composed of two modules: the upper module angulates the surgical instruments carried by the end effector, and the lower module positions them. The Autoguide Targeting Unit operates while covered by the Autoguide Targeting Unit Sterile Drape.

Note: The end effector is a device at the end of the Autoguide Targeting Unit that interacts with

the environment. The guiding joints, guiding inserts, and the Stealth Autoguide form the end effector. The end effector is a Type CF rated patient applied part.

2 28248 Stealth Autoguide

secure instruments in the tracker with a knob screw. The tracker is connected to the Autoguide Targeting Unit by the Autoguide Guiding Inserts and the Autoguide Guiding Joints. The tracker is sterilizable. The StealthStation the Stealth Autoguide mounted to the tracker.

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Tracker: Holds and guides surgical instruments. The user can

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Tracker by detecting the spatial location of the passive optical spheres

system infrared camera tracks the position and orientation of

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Tracker

3 27584 Autoguide Guiding Joint: Two Autoguide Guiding Joints connect the Autoguide

Targeting Unit to the Autoguide Upper Guiding Insert and Autoguide Lower Guiding Insert. The Autoguide Guiding Joints transmit the movement of the Autoguide Targeting Unit modules to the Autoguide Guiding Inserts and the Stealth Autoguide Unit Sterile Drape. The Autoguide Guiding Joints are sterilizable.

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

Autoguide

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

Autoguide Autoguide Lower Guiding Insert is sterilizable.

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Tracker. The Autoguide Upper Guiding Insert is sterilizable.

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

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Tracker, through the Autoguide Targeting

6 29480 Autoguide Positioning Arm: An articulating arm for flexible pre-positioning of the

Autoguide Targeting Unit. The Autoguide Positioning Arm can be locked in a specific position by the user. The arm has two starburst interfaces. The large starburst interface connects with the Autoguide Head Clamp Adapter and the small starburst interface connects to the Autoguide Targeting Unit.

Introduction

Stealth Autoguide™ system details

7 29439 Autoguide Head Clamp Adapter: Interface between the patient head clamp and the

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

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II Arm.

8 29193 Autoguide Strain Relief Box: Mounted to the side-rail of the operating room table.

Distributes power and data to system components and prevents cables from pulling on the Autoguide Control Unit and Autoguide Targeting Unit.

9 28080 Autoguide Control Unit: The primary user interface for the system. The Autoguide

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

0 28635 Autoguide Power and Network Unit: Provides power for the Autoguide Control Unit and

Autoguide Targeting Unit. Connects and provides a data interface to the StealthStation

- 29440 Autoguide Targeting Unit Cable Set: Provides power and control for the Autoguide

Targeting Unit. The cable set consists of two identical cables combined by a mechanical fixation piece. This mechanical fixation piece is mounted to a mechanical recess on the large starburst adapter of the Autoguide Positioning Arm to prevent cables from pulling on the Autoguide Targeting Unit.

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

Autoguide Power and Network Unit.

q Power cord: Cable between the Autoguide Power and Network Unit and the wall outlet. w Network cable: Ethernet cable between the Autoguide Power and Network Unit and the

Ethernet port on the StealthStation

Surgical Instruments

This section introduces the surgical instruments that are compatible with the Stealth Autoguide™ system and their main functions.

The surgical instruments are a set of drill guides, reducing tubes, and obturators that are inserted into the Stealth Autoguide needed to execute the surgical procedures. Each instrument is marked with the product number and the corresponding procedure for identification.

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system.

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Tracker and used to support drilling and guide various instrumentation

system.

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

• “SEEG” - Surgical instruments to be used for placement of sEEG (stereo electroencephalography) bolts (refer to items 3, 4, 6, 7, and 11 in Figure 3)

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

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Bone Anchors

Introduction

Stealth Autoguide™ system details

1 28322 Autoguide Burr Hole Drill Guide is a tube with sharp teeth on its distal end. The drill

guide is anchored to the skull through gentle hammering and provides guidance and stability to the Midas Rex™ Legend™ Depth Stop Attachment (ASDS01) while creating a cranial access hole. This drill guide is compatible with the Legend Biopsy Tool (DS1TD75).

Figure 3: Surgical instruments

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Depth Stop Twist Drill 7.5 mm Burr Hole

2 28334 Autoguide Burr Hole 2.2 mm Reducing Tube consists of a 2.2 mm inner-diameter

reducing tube that can be introduced directly into the Stealth Autoguide

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

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Tracker to guide a

3 28340 Autoguide Stab Incision Obturator is a rod with a sharp point used to aid in the

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

4 28326 Autoguide Stab Incision Drill Guide is a tube with sharp teeth on its distal end. The

drill guide is anchored to the skull through gentle hammering and provides guidance and stability to the Midas Rex™ Legend™ Depth Stop Attachment (ASDS01) while creating a cranial access hole. This drill guide is compatible with the Autoguide Stab Biopsy 2.2 mm Reducing Tube (28330), the Autoguide sEEG 2.4 mm Reducing Tube (28336), the Autoguide sEEG 4.0 mm Reducing Tube (28328), the Legend (DS1TD32), and the Legend (DS1TD24).

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Depth Stop Twist Drill 2.4 mm sEEG Bolt Placement Tool

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Depth Stop Twist Drill 3.2 mm Stab Biopsy Tool

5 28330 Autoguide Stab Biopsy 2.2 mm Reducing Tube consists of a 2.2 mm inner-diameter

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

6 28336 Autoguide sEEG 2.4 mm Reducing Tube consists of a 2.4 mm inner-diameter

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

7 28328 Autoguide sEEG 4.0 mm Reducing Tube consists of a 4.0 mm inner-diameter

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

Introduction

Stealth Autoguide™ system details

8 28324 Autoguide Visualase

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

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

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Tool (DS1TD32L).

9 28338 Autoguide Visualase

of the Autoguide Visualase

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

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Depth Stop Twist Drill 3.2 mm Long

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

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Drill Guide (28324). The obturator is inserted into the drill guide, introduced into the skin incision, and temporarily anchored onto the skull through gentle hammering. The obturator provides guidance for subsequent anchoring of the Autoguide Visualase anchored to the skull, the Autoguide Visualase

0 28332 Autoguide Visualase

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

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

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

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

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Obturator is removed.

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Tracker to guide the

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

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

= 27565 Autoguide Visualase

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

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Tracker.

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Tracker.

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Height Guide is similar to the Autoguide Stab Incision Height

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Bone Anchor fits under the Autoguide

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Height Guide also provides the verification tip for the

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Tracker is

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Tracker

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

user hammers the Autoguide Visualase

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Drill Guide (28324) and the Autoguide Stab Incision

Drill Guide (28326).

Introduction

Scope of this manual

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

Contact information

If a serious incident occurs in relation to the use of this system, report it to Medtronic Navigation. If a serious incident occurs in the European Union, also report it to the competent authority in the Member State where the incident occurred.

Telephone

Technical support worldwide +1 720 890 3160

Technical support in the USA +1 800 595 9709

General +1 720 890 3200

Fax +1 720 890 3500

Mailing address

Introduction

Contact information

Medtronic Navigation, Inc.

826 Coal Creek Circle

Louisville, Colorado 80027

USA

Medtronic E.C. authorized representative

Medtronic B.V.

Earl Bakkenstraat 10

6422 PJ Heerlen

The Netherlands

Tel. +31 45 566 80 00

Australia

Medtronic Australasia Pty Ltd

2 Alma Road

Macquarie Park, NSW 2113

Australia

Tel. 1800 668 670 (within Australia)

Introduction

Contact information

World Wide Web

www.medtronic.com

E-mail

E-mail product enhancement requests to: dl.navsuggestions@medtronic.com

2 Product Description

User interface

Autoguide Targeting Unit

Figure 4: Symbols on the Autoguide Targeting Unit

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

1 HOME: Autoguide Targeting Unit in home position. The Autoguide Targeting

Unit is in its center position for all axes of movement.

2 OUT OF REACH: Trajectory out of reach. No automatic alignment is possible. 3 ERROR OR WARNING: Error or warning during operation or on the device.

Details for the warnings are shown on the display of the Autoguide Control Unit.

4 IN REACH: Trajectory in reach. Automatic alignment is possible. 5 ALIGNED: Trajectory aligned with the active surgical plan. Symbol flashes when

a deviation of more than 1 mm from the active surgical plan is detected.

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

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.

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

Meaning of single symbols of the main operation screens

Homing state symbols

Autoguide Targeting Unit in home position

Autoguide Targeting Unit not in home position

Reachability information symbols

No reachability information available. This can have several causes:

• No connection to the StealthStation

• Tool not verified

• Currently not in the Navigation task on the StealthStation

• No surgical plan available

• Autoguide Targeting Unit not in home position after gross positioning

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system

Product Description

User interface

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system

flashing

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

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

Trajectory aligned and move to plan is complete

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

operation” on page 25.

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

Product Description

User interface

Network connection symbols

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

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

Communication with the StealthStation

Speed level symbols

Low speed

Normal speed

Warning / Error symbols

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

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

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system.

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system is successfully established.

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

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

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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.

Product Description

User interface

Warning screens

Warnings are displayed by three different exception screens.

Exception Screen Details

Auto Recovery Exception

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

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

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

Confirmable Exception

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

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

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

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

Stop Exception

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

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

List of warning and error symbols

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

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

Product Description

User interface

Symbol Description Type of exception

Surgical plan has been changed Confirmation is necessary.

Cable fault Auto recovery

Collision warning Confirmable

Confirmable

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

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

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

procedure.

Enable button fault Confirmable

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

behavior mode.

Over temperature fault Stop exception

Hardware fault Stop exception

Stop exception or Auto recovery

Confirmable

Service needed Stop exception

Speed fault Confirmable

SD card error Confirmable

Product Description

User interface

Symbol Description Type of exception

Configuration error Stop exception

Communication with the StealthStation during movement to plan

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system was lost

Confirmable

Service mode

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

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

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

Figure 8: Service mode screens

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systems. Use the

EMC Silent mode

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

Starting the EMC Silent mode

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

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system. Manual or automatic

+ 98 hidden pages

Medtronic 29631 Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual

1 Introduction

Intended use

Indications for use

Clinical benefits

Contraindications

Operating Principle

Description of the Stealth Autoguide™ System

Navigational accuracy

System installation

User profiles

Compatibility

Side effects

Potential complications

Material composition

Conventions

Warnings and precautions

Stealth Autoguide™ system details

Scope of this manual

Related documents

Contact information

2 Product Description

User interface