Medtronic 9735666 Instructions for Use
StealthStation™ S8
Planning Station
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/indications for use 3
Contraindications 3
Side effects 3
Material composition 3
Description of the StealthStation
System installation 4
Use profile 4
Potential complications 4
Clinical benefits 4
Conventions 4
Warnings and precautions 5
Warnings 5
Precautions 5
Content of this manual 6
Related documents 6
Reporting 6
Contact information 7
Telephone 7
Mailing address 7
Medtronic E.C. authorized representative 7
Australia 7
World Wide Web 7
E-mail 8
™
Planning Station 3
2.System overview
How the system works 9
System components 9
Computer 9
Touchscreen monitor 10
Keyboard and mouse 10
3.System Operation
Computer Input/Output panel 11
Computer I/O panel connections 11
System security 14
StealthStation™ S8 Planning Station security functionality 14
Best practices to maintain security of the StealthStation
What to do if you suspect the StealthStation™ S8 Planning Station has been compromised 14
Network connection information 15
Connecting to a wired network 15
Configuring user accounts and changing passwords 16
System set up 18
Starting the system 18
Launching the software 18
System shutdown 19
Exiting the software 19
Shutting down the system 19
Cleaning the planning station 19
Storing the planning station 19
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S8 Planning Station 14
4.System specifications
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System specifications 21
System electromagnetic emissions and immunity declarations 22
Electromagnetic emissions and immunity declarations 22
Warnings and precautions 22
5.Troubleshooting
Component connections 25
Running the self-test tool 25
System power 25
No power to system 25
Monitor 26
The monitor screen is blank 26
The monitor screen displays ‘no video detected’ 26
The display on the monitor is distorted 26
Mouse and keyboard 26
Recommended maintenance 27
Replacing the power cord and cables 27
System disposal 27
6.Symbols
Explanation of symbols on package labeling 29
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1 Introduction
Intended use/indications for use
The StealthStation™ Planning Station is intended as a planning tool to aid in preparation for surgery.
The planning station can also be used to send and receive patient exams across the hospital
network. The StealthStation
viewing of DICOM datasets and pre-planning for the use of navigation may be appropriate.
Contraindications
Medical conditions which contraindicate the use of a Medtronic computer-assisted surgery system
and its associated applications include any medical conditions which may contraindicate the medical
procedure itself.
Side effects
The Medtronic computer assisted surgery system and its associated applications do not
independently produce any side effects. When used in conjunction with navigated instruments for
surgical procedures, the associated side effects are the same as those for the procedure itself. See
the procedure pocket guides for detailed lists of the side effects associated with these procedures.
™
Planning Station is indicated for any medical condition in which
Material composition
Material contained in product that can cause an allergic reaction: nickel.
For additional materials of concern information such as REACH, CA Prop 65, or other product
stewardship programs, go to www.medtronic.com/productstewardship.
Description of the StealthStation™ Planning Station
The StealthStation™ Planning Station is intended to provide a consistent experience between
preoperative planning and navigation with the StealthStation
access to planning features in the StealthStation
users the flexibility to plan for surgical procedures at any time. In addition, the planning station can
be used to send and receive patient images across the hospital network. Surgical plans created on
the StealthStation
The StealthStation™ Planning Station is comprised of a computer with an operating system, a
monitor with a stand, a keyboard, and a mouse.
™
Planning Station can be transferred to the StealthStation™ navigation system.
™
software on a desktop computer, which gives
™
system. The planning station provides
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Introduction
System installation
System installation
The StealthStation™ S8 Planning Station is installed by qualified Medtronic personnel only. If you
have any questions about your system installation, contact Medtronic Navigation
Use profile
The intended user profile for the StealthStation™ system is operating room staff, including surgeons,
nurses, surgical technologists, and hospital biomedical engineers.
The intended patient population for the system is patients for whom stereotactic image guided
surgery is appropriate.
Potential complications
Potential complications related to the use of a Medtronic computer-assisted surgery system and its
associated applications are the same as the potential complications for the procedures in which the
system is used. See the procedure pocket guides for detailed lists of the potential complications
associated with these procedures.
Clinical benefits
™
.
Clinical benefits related to the use of a Medtronic computer-assisted surgery system and its
associated applications are the same as the clinical benefits for the procedures in which the system
is used. See the procedure pocket guides for detailed lists of the clinical benefits associated with
these procedures.
Conventions
This document employs the following conventions:
• Warnings are preceded by the word Warning. Failure to observe a warning may result in physical
• Precautions are preceded by the word Caution. Failure to observe a precaution could result in
• References to buttons that appear on the system display are enclosed in square brackets. For
• References to menu options that appear on the system display are printed in bold letters. For
injury to the patient or operator. Pay special attention to these items.
damaged equipment, forfeited time or effort, or the need to abort use of the system.
example:
Click [Edit...].
example:
Choose Clear from the list.
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• Instructions to click an object on the screen means to place the pointer over the object using the
system mouse, and press and release the left mouse button. Instructions to tap an object on the
screen means to tap the screen with a finger, a gloved finger, or a capacitive stylus. Click and tap
are used interchangeably.
Warnings and precautions
Warnings
Warning: The system hardware and software should be used only by qualified medical
professionals who are trained in performing surgery and familiar with computer-assisted surgery
systems.
Warning: Inspect all visible system components for damage before use. Do not use any component
that is visibly damaged.
Warning: To avoid the risk of electric shock, this equipment must only be connected to a grounded
power outlet.
Introduction
Warnings and precautions
Precautions
Warning: Avoid dripping any fluids into any enclosure on the StealthStation
Shut down the system, disconnect the power, and allow the system to dry if you suspect fluids
may have entered any part of the system.
Warning: The system is not suitable for use in the presence of a flammable, anesthetic mixture with
air, oxygen, or nitrous oxide.
Warning: Do not modify the StealthStation
Medtronic Navigation, Inc. Prohibited modifications include but are not limited to: altering,
repairing, or replacing system components; altering software provided by Medtronic; updating the
operating system or drivers; and installing any software that is not provided by Medtronic,
including anti-virus software. Secure the system to prevent unauthorized modifications.
Unauthorized modifications could render the system unsafe or ineffective for its intended use.
Warning: Follow system component maintenance and care instructions.
Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
Caution: The system mouse and keyboard are not designed for sterilization and may be damaged
if sterilization is attempted.
Caution: System components are fragile. Use care when handling system components.
™
S8 Planning Station without prior written consent from
™
S8 Planning Station.
5
Introduction
Content of this manual
Content of this manual
This system manual is intended as a reference document for biomedical engineers or other qualified
personnel who require familiarity with and details about the StealthStation
This manual is not a software usage manual. For instructions on using specific software, refer to the
instructions for use provided with the software.
Related documents
For software instructions, refer to the specific software’s instructions for use.
Reporting
If a serious incident occurs in relation to the use of this Medtronic computer-assisted surgery 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.
™
S8 Planning Station.
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Contact information
Telephone
Technical support worldwide +1 720 890 3160
Technical support in the USA +1 800 595 9709
General +1 720 890 3200
Fax +1 720 890 3500
Mailing address
Medtronic Navigation, Inc.
826 Coal Creek Circle
Louisville, CO, U.S.A.
80027
Introduction
Contact information
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)
World Wide Web
www.medtronic.com
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Introduction
Contact information
E-mail
E-mail product enhancement requests to: dl.navsuggestions@medtronic.com
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2 System overview
How the system works
The StealthStation™ S8 Planning Station is a desktop workstation comprised of a computer that is
compatible with the StealthStation
planning station may be used as a temporary server for assembling and transferring patient data
before and after a procedure.
Patient images may be transferred to the planning station from a CT scan, MR scan, or other
compatible DICOM imaging modality. The software reconstructs the image data to display the patient
anatomy from a variety of perspectives (axial, sagittal, coronal, oblique) and 3-dimensional
renderings. The planning station provides surgeons the flexibility to plan for surgical procedures at
any time and without utilizing a full surgical StealthStation™ system. Surgical plans created on the
StealthStation
or to a PACS.
™
S8 Planning Station can be transferred to the full surgical StealthStation™ S8 system
System components
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S8 software, a touchscreen monitor, keyboard, and mouse. The
Figure 1: StealthStation™ S8 Planning Station components
Computer
The StealthStation™ S8 Planning Station desktop computer is compatible with the StealthStation™
S8 software. The computer includes a CD/DVD drive, USB ports, and an Ethernet port for data input
and output.
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