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

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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

1

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

2

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.

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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.

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Planning Station can be transferred to the StealthStation™ navigation system.

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software on a desktop computer, which gives

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system. The planning station provides

3

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.

4

• 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.

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S8 Planning Station without prior written consent from

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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.

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S8 Planning Station.

6

Contact information

Telephone

Technical support worldwide [phone]

Technical support in the USA [phone]

General [phone]

Fax [phone]

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. [phone]

Australia

Medtronic Australasia Pty Ltd

2 Alma Road

Macquarie Park, NSW 2113

Australia

Tel. [phone] (within Australia)

World Wide Web

www.medtronic.com

7

Introduction

Contact information

E-mail

E-mail product enhancement requests to: [e-mail]

8

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.

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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.

9

System overview

System components

Touchscreen monitor

The touchscreen monitor is a high-resolution, flat panel computer display with built-in speakers. The
capacitive touchscreen interface can be controlled by a finger or gloved finger.

Caution: Do not use a hard object or a sharp object to control the touchscreen interface because

the object may damage the screen.

Keyboard and mouse

A wired USB keyboard and a wired mouse are provided with the StealthStation™ S8 Planning
Station. They are used to control the system, and they can be plugged into any USB port on the
planning station computer.

Warning: Only use the Medtronic supplied keyboard and mouse with the StealthStation

Planning Station. Connecting incompatible items could render the system unsafe or ineffective
for its intended use.

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S8

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3 System Operation

Computer Input/Output panel

The planning station computer includes input/output panels with external connection ports for
various input and output devices. The panels are on the front and rear of the computer and under
the touchscreen monitor.

Warning: Connect only items that are specified as part of the StealthStation

or compatible with the system. Connecting incompatible items could render the system unsafe
or ineffective for its intended use.

Computer I/O panel connections

1 CD/DVD-ROM drive
2 CD/DVD-ROM eject button

Figure 2: Front I/O panel

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S8 Planning Station

3 Power button
3 2 super-speed USB 3.0 ports for loading patient scans onto the system

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System Operation

Computer Input/Output panel

Figure 3: Rear I/O panel

1 USB 2.0 ports for the keyboard, the mouse, and the touch interface on the

touchscreen monitor

2 Display port: Disabled
3 Display port: Disabled
4 Display port: Disabled
5 Display port: Disabled
6 USB-C: Connects the computer to the touchscreen monitor via a USB-C to HDMI

adapter

7 Ethernet: Connects the system to the site Local Area Network (LAN)
8 Ethernet: Disabled
9 Power cord

Note: Do not use disabled ports 2 (Display port), 3(Display port), 4(Display port), 5(Display

port) and

8(Ethernet).

12

Figure 4: I/O panel under the touchscreen monitor

1 Power
2 HDMI: Connects the touchscreen monitor to the computer
3 DVI-I: Disabled

System Operation

Computer Input/Output panel

4 Display port in: Disabled
5 Audio in: Disabled
6 Audio out: Disabled
7 VGA port: Disabled
8 USB Type B: Connects the touchscreen monitor to the computer
9 Functional ground

Note: Ports

S8 Planning Station or compatible with the planning station.

The user assumes responsibility for verifying the output quality of any attached devices that were not
supplied for this use by Medtronic.

3 through 7 are not used for any item that is specified as part of the StealthStation

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13

System Operation

System security

System security

Good security practices are needed to protect both patient data and the integrity of any network­connected product. The StealthStation
facilitate management of security. These features work in conjunction with the security practices of
hospitals and clinics to provide safe and secure operation of the StealthStation
and to protect attached networks and devices.

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S8 Planning Station includes features and functionality that

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S8 Planning Station

StealthStation™ S8 Planning Station security functionality

The following features and functions help to protect the integrity of the system, the data it contains,
and any networks or other devices the system may be connected to:

• Access control: The StealthStation
ability to include password protection, for different system user types. User accounts may also
be integrated with hospital network privileges. Controlling access to the StealthStation
Planning Station has the ability to prevent unauthorized user access to the system, the data
contained on the system, and other devices that may be networked with the system.

• Encryption: The StealthStation
medical images and surgical plan information when the system is not in use.

• Antivirus: With the antivirus product that is installed on the system by Medtronic, users can
update virus definitions and run an on-demand, on-disk antivirus scan to identify potential threats.

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S8 Planning Station has specified user accounts, with the

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™

S8 Planning Station encrypts directories containing patient

S8

Best practices to maintain security of the StealthStation™ S8 Planning
Station

• Maintain good physical controls over the StealthStation™ S8 Planning Station. Keeping the
system in a secure location and environment reduces the probability of unauthorized access and
unauthorized modifications to the system.

• Only connect the StealthStation

• Only install Medtronic supplied updates and patches for security purposes.

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S8 Planning Station to managed, secure networks.

What to do if you suspect the StealthStation™ S8 Planning Station has
been compromised

If you suspect that the system has been compromised by a security threat, follow these steps:

1. Shut down the system.

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2. Disconnect the StealthStation

3. Contact Medtronic Navigation

potential security threats.

S8 Planning Station from any networks or other devices.

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technical support for further assistance in troubleshooting

14

Network connection information

A network connection is provided on the StealthStation™ S8 Planning Station. The network
connection is used to transfer data, including patient images and surgical plans, to and from the
system. The network connection may also provide the ability for Medtronic Navigation
support to monitor and troubleshoot remotely, if this capability has been authorized and configured.
The user network must be 10/100/1000 BASE-T to function with the StealthStation
Station.

System Operation

Network connection information

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technical

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S8 Planning

For network connection, the StealthStation
the background that is always checking for DICOM data being pushed to the system. If this
application is not running, no data will be accepted. If there is a network failure, a CD/DVD-ROM or
a USB drive may be used to transfer images to or from the system. Navigated procedures may be
delayed while alternate media is used for image transfer, or navigation may be aborted if alternate
image transfer media is unavailable.

Connecting the StealthStation
could result in previously unidentified risks to patients, operators, or third parties. Users should
identify, analyze, evaluate, and control these risks. Subsequent changes to the network could reduce
the functionality of the system or introduce new risks, and therefore require additional analysis. The
following activities are examples of changes that could change the risk profile and require analysis:

• Changing the network configuration

• Connecting additional items to the network

• Disconnecting items from the network

• Upgrading equipment connected to the network

See “Configuring antivirus scan settings” on page 16 to configure antivirus scan settings and control
identified risks.

Connecting to a wired network

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S8 Planning Station includes an application running in

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S8 Planning Station to an IT network that includes other equipment

Follow these steps to connect the StealthStation™ S8 Planning Station to a network:

1. Plug in an Ethernet cable.

2. Follow these steps to open the StealthStation Configuration tool.

a. At the login screen, select Other and then log in using the Stealth Admin (stealthadmin)

username and password.

b. Double-tap StealthStation Configuration.

c. Enter the Stealth Admin password and tap [OK].

3. Select the Network Settings tab.

4. Tap [Configure Network Settings].

5. Select DHCP or Static.

• If you choose DHCP, tap [OK]. You do not need to fill in any information.

15

System Operation

Network connection information

• If you choose Static, fill in Static IP, Netmask, Default Gateway, and Primary DNS. Optionally,

fill in Secondary DNS and Tertiary DNS. These fields are limited to numbers and periods only.
Ta p [OK].

Current Network Configuration information displays.

Configuring user accounts and changing passwords

The StealthStation™ S8 Planning Station is configured with 3 accounts: Stealth Admin, Stealth User,
and StealthViz User. Each of these 3 accounts has a default password, which can be changed. For
assistance with the default passwords for these accounts, contact Medtronic Navigation
support.

Follow these steps to configure accounts for users to log in to the system.

1. At the login screen, select Other then log in using the Stealth Admin (stealthadmin) username

and password.

2. Double-tap StealthStation Configuration.

3. Enter the Stealth Admin password and tap [OK].

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technical

4. Tap the System Settings tab.

5. Tap [Change Date and Time], and then use the drop-down menus to change the date and the

time zone. To change the time, type in the time.

Set the time before connecting to Active Directory so that the time will be associated with the
Active Directory server. The time needs to be within 5 minutes of the World Clock time and the
Active Directory server time.

6. Tap the Authentication Settings tab.

7. Choose either Local Authentication or Active Directory Authentication.

• If you choose Local Authentication, then there are 3 password options.

– New Stealth Admin Password

– New Stealth User Password

– New StealthViz User Password

To change a password, enter the password and tap [Reset].

• If you choose Active Directory Authentication, obtain information from the hospital IT

administrator to fill in all fields, and then tap [Join Domain].

– If joining the domain is successful, tap [OK]. Then tap [Change Password] to change

one of the 3 passwords.

– If joining the domain fails, tap [Show Details] to display additional information that you

can provide when you call Medtronic Navigation

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technical support.

16

Configuring antivirus scan settings

An antivirus product is installed on the StealthStation™ S8 Planning Station. The default setting is to
scan the root directory (/). To select a different directory to scan or to exclude directories or files from
antivirus scans, follow these instructions.

System Operation

Network connection information

Note: For instructions on updating antivirus definitions, see “Updating antivirus definitions” on page

17.

1. At the login screen, select Other then log in using the Stealth Admin username and password.

2. Double-tap StealthStation Configuration.

3. Enter the Stealth Admin password and tap [OK].

4. Tap the Antivirus Settings tab.

5. Choose the directory to scan.

6. Choose directories or files to exclude from scans.

7. Tap [Configure].

If the Enter Directory to Scan field is empty or if any directories or files are invalid, an error
message appears.

Updating antivirus definitions

An antivirus product is installed on the StealthStation™ S8 Planning Station. Follow hospital IT
policies regarding how frequently to update the antivirus definitions and scan the system according
to these instructions:

1. At the login screen, select Other and then log in using the Stealth Admin username and

password.

2. Double-tap StealthStation Self-Test.

3. Make sure that the StealthStation

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system is connected to the Internet.

4. Tap the Antivirus Status tab.

• To update antivirus definitions, tap [Update Antivirus Definitions].

• To scan the system, tap [Scan].

The default setting is to scan the root directory (/). To select a different directory to scan or to
exclude directories or files from antivirus scans, see “Configuring antivirus scan settings” on
page 16.

– If antivirus definitions have never been updated, a message displays in the Last

Antivirus Definition Update field, and the [Scan] button is disabled. To enable scanning,
update antivirus definitions.

– If the scan fails, tap [Details] to display additional information that you can provide when

you call Medtronic Navigation

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technical support.

17

System Operation

System set up

Remote Support

Remote Support is a digital service that allows Medtronic to provide features such as: remote
diagnostics, system configuration backup and restoration, predictive part failure reporting, remote
troubleshooting support using a real-time-screen-share feature, and remote software install. Remote
Support requires an active, secured Internet connection between the Covered Product and
Medtronic for connectivity. Medtronic Remote Support is securely enabled by the Medtronic Pathway
Connect
device on-site to Medtronic Pathway Connect

443. The StealthStation

server when the following conditions are met:

• System is powered on.

• System is connected to the Internet via Ethernet or Wi-Fi.

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server, Medtronic’s digital service cloud solution. All communication originates from the

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System will attempt to communicate with Medtronic Pathway Connect™

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server as an outbound HTTPS connection on port

The screen-share function requires the person operating the StealthStation
screen-share session by physically opening the Remote Support application in the StealthStation
Configuration tool with the assistance of Medtronic Technical Support. When a session is initiated,
the Medtronic Pathway Connect
Technical Support agent and the system for the duration of the session using certificate-based
authentication.Contact Medtronic Technical Support for additional information about enabling
Remote Support on your system.

System set up

Warning: Prevent fluid from entering any part of the StealthStation™ S8 Planning Station. If you

suspect fluid has entered any part of the unit, turn the system off immediately using the steps in
“System shutdown” on page 19, disconnect from electrical power, and allow adequate drying time
before powering the system back on.

Starting the system

1. Press the power button on the monitor.

2. Press and hold the LED power switch located on the front of the computer.

The power switch illuminates blue when the system is on.

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system to initiate a

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server creates a point-to-point connection between the Medtronic

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Launching the software

Warning: Before using the system, verify monitor functionality by ensuring that the monitor responds

to touch and displays the expected screen output.

If the touchscreen is not functioning properly, use alternative input methods (mouse and keyboard).
Call Medtronic Navigation

1. Type in your username and password to log in to the system (if required at your facility).

2. Reference the software pocket guide for instructions on launching the software.

18

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technical support to report touchscreen functionality issues.

System shutdown

Exiting the software

Reference the software pocket guide for instructions on exiting the software.

Shutting down the system

After use, shut down the system. Follow these steps to shut down the system.

1. At the login screen, tap the gear icon in the upper right corner of the screen to access the drop-

down menu.

2. Tap [Shut Down].

The computer will fully shut down.

3. Press the power button on the monitor to shut down the monitor.

Emergency shutdown

System Operation

System shutdown

If you need to shut down the system quickly in an emergency, or if you are not able to exit the
software, follow this procedure:

1. Press and hold the blue LED power button on the computer until the computer shuts down.

2. Press the power button on the monitor to shut down the monitor.

Cleaning the planning station

For instructions on cleaning the system, refer to the StealthStation™ S8 cleaning instructions
(9735727).

Storing the planning station

When the planning station is not in use, store the planning station in an environment within the
following temperature and humidity ranges:

Storage temperature 15° to 30°C (59° to 86°F)

Relative humidity 20% to 80% Non-condensing

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System Operation

Storing the planning station

20

4 System specifications

System specifications

The specifications listed apply to system operation under typical conditions.

Tab le 1: StealthStation™ S8 Planning Station specifications

Operating temperature 18° to 30°C (64° to 86°F)

Operating pressure 101.3 kPa to 69.7 kPa

Operating altitude -50 m (-164 ft) minimum

3000 m (9842 ft) maximum

Shipping temperature -29° to 60°C (-20° to 140°F)

Storage temperature 15° to 30°C (59° to 86°F)

Input voltage (computer
and monitor)

Input frequency (computer
and monitor)

Maximum power
(computer)

Maximum power (monitor) 60 W

Typical power dissipation
(computer)

Typical power dissipation
(monitor)

Recommended power
supply cord

Recommended
overcurrent protection

Relative humidity 20% to 80% Non-condensing

Monitor dimensions 389 mm high by 648 mm wide by 63 mm deep (15.3 in high by

~100–~230 VAC

50–60 Hz

920 VA

200 W

50 W

#18AWG (0.75mm

15A

25.5 in wide by 2.5 in deep)

2

) minimum

Monitor stand dimensions 29.2 cm wide by 35.6 cm high by 24.1 cm deep (11.5 in wide by 14 in high

by 9.5 in deep)

Monitor weight 10.93 kg (24 lbs)

Monitor display Resolution = 2560 x 1440 pixels, 60 Hz

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System specifications

System electromagnetic emissions and immunity declarations

Computer footprint 22.9 cm wide by 34.3 cm deep by 21.6 cm high (9 in wide by 13.5 in deep

Computer weight approximately 9.0 kg (19.8 lb)

by 8.5 in high)

System electromagnetic emissions and immunity
declarations

Tab le 2: Guidance and Manufacturer's Declaration - Cables, Transducers, and Accessories

The listed I/O cables, transducers, and accessories have been determined by Medtronic to be compliant with the

emissions and immunity requirements.

Medtronic Part

Number

System Equipment

M704430B667 Computer NA NA

M704430B336 Monitor NA NA

M704430B013 Keyboard NA NA

M704430B235 Mouse NA NA

Cables

Description Cable Length Shielded (Y/N)

Generic Ethernet cable < 3.0 m (9 ft 8 in) Yes

M704430B035 HDMI cable 2.4 m (8 ft) Yes

M010929C001 USB-C to HDMI video converter 93 mm (3.7 in) No

M704430B036 USB cable for touchscreen 2.0 m (6 ft 6 in) Yes

M704430B237 USB cable for keyboard 1.8 m (6 ft) Yes

Electromagnetic emissions and immunity declarations

Note: The StealthStation™ S8 Planning Station has undergone Electromagnetic Compatibility (EMC)

testing and, in expected use conditions, is unlikely to impact other systems or devices.

Note: The StealthStation

for a Class B digital device, pursuant to Part 15 of the FCC Rules. This device may not cause
harmful interference and this device must accept any interference received, including
interference that may cause undesired operation.

Warnings and precautions

Warning: RF emitters typically found in an operating room can affect the StealthStation™ S8

Planning Station.

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S8 Planning Station has been tested and found to comply with the limits

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System specifications

Electromagnetic emissions and immunity declarations

Warning: RF interference, including RFID or other low frequency technologies, could hamper

operation of the StealthStation™ S8 Planning Station or the operation of other nearby electrical
devices. If you suspect either of these conditions, move the conflicting equipment farther apart,
separate the equipment with an RF barrier, or discontinue use of the system.

Caution: The StealthStation

™

S8 Planning Station needs special precautions regarding EMC
(electromagnetic compatibility) and needs to be installed and put into service according to the
EMC information provided in table 2 in order to remain compliant.

Caution: The use of accessories and cables other than those specified, with the exception of cables

sold by Medtronic Navigation
increased emissions or decreased immunity of the StealthStation

™

as replacement parts for internal components, may result in

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S8 Planning Station.

23

System specifications

Electromagnetic emissions and immunity declarations

24

5 Troubleshooting

Component connections

System malfunctions are sometimes the result of loose, misconnected, or disconnected cables. Do
not disconnect any cables unless instructed to do so by a Medtronic Navigation
representative.

Running the self-test tool

Follow these steps to test whether system components are properly connected and configured.

Note: The StealthStation

components listed in this section may not be included in your system configuration. Therefore,
“Unavailable” status for certain components may be normal in some system configurations.

1. Open the StealthStation Self-Test tool.

a. At the login screen, select Other and then log in using the Stealth Admin username and

password

b. Double-tap StealthStation Self-Test.

2. Tap the Software Information tab to view the status of operating system services and user

input devices such as the keyboard, mouse, and touchscreen.

Green “Connected” status indicates proper connection.

Red status indicates a connection problem. If a user input device has red status, take the
following actions:

• Check cable connections.

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technical support

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S8 system is available in multiple configurations. All of the system

• Plug the device in to a different port.

System power

No power to system

• Is the system plugged in to an electrical power outlet? If not, plug the power cord into an electrical
power outlet.

• Is the system plugged into a power outlet that supplies power? Test the outlet with a multimeter
or a wall power circuit tester. If there is no power, use an electrical power outlet that is supplying
power.

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Troubleshooting

Monitor

• Check all system connections. Check cables for crimps or damage. Check connector housing
and pins for bent or broken components. Contact Medtronic technical support to replace any
damaged cables. If necessary, power down the system and re-connect all external cables and
devices (monitor, keyboard, and mouse) and turn the system power back on.

Monitor

The monitor screen is blank

Note: The monitor enters sleep mode after periods of inactivity. Move the mouse to make sure that

the monitor is not in sleep mode.

The system is off or the monitor power is off. Verify that both the system and monitor are receiving
power. The monitor is turned on and receiving a signal if you can hear a hum emanating from the
back of the monitor.

The monitor screen displays ‘no video detected’

Adjust the screen display settings with the monitor’s on-screen display button.

1. Press the on-screen display button located below the on-screen display symbol on the right side

of the monitor.

Figure 5: On-screen display symbol

2. Use the up/down display buttons located next to the on-screen display button to move through

the display menu.

3. Press the on-screen display button to choose Video Input Select.

4. Use the up/down display buttons to move through the Video input select menu.

5. Press the on-screen display button to select HDMI Mode.

The display on the monitor is distorted

• The contrast settings are incorrect in the software. Adjust the Level (brightness) and Width
(contrast) settings for images using the on-screen controls in the application software.

• If adjusting Level and Width does not resolve the problem, shut down and reboot the system.

• If the problem persists, call Medtronic Navigation

™

for technical support.

Mouse and keyboard

The mouse and keyboard are optional input devices. Make sure that the mouse or keyboard cable
is properly plugged in on both ends and is connected to a USB port on the system. If a mouse or a
keyboard is connected to a USB port on the system, and the system is not responding to input from
the device, follow these troubleshooting instructions.

26

• If the mouse buttons are not operational, the mouse may have been disconnected at start up.
Reconnect the mouse to the system computer and reboot the system.

Turn the system power off, wait 10 seconds, and turn the system power back on.

• If the cursor does not move on the screen, the computer is not responding. Reboot the system.

• If the keyboard is not operational, the keyboard may have been disconnected at start up.

Reconnect the keyboard to the system computer and reboot the system.

Recommended maintenance

Because the StealthStation™ S8 Planning Station contains no user-repairable parts, the interior of
the system is normally inaccessible. However, it may occasionally be necessary for a qualified
Medtronic service person to remove panels and access interior components.

Troubleshooting

Recommended maintenance

The StealthStation
which is consumed during operation.

The StealthStation
and annual inspection and testing.

Please contact Medtronic Navigation, Inc. (see page 7) to schedule a full maintenance and system
check appointment.

Inspection should include:

• Inspect cables for damage, cuts, or connector wear.

• Inspect the following items for damage, wear, or unexpected behavior: monitor and computer.

Testing should include:

• Verify full functionality of keyboard, mouse, computer, monitor, and fans.

• Verify full functionality of the software including image load, image settings, and file export.

• Verify system electrical safety.

™

S8 Planning Station contains no user-serviceable components and no material

™

S8 Planning Station and its associated components require cleaning as needed

Replacing the power cord and cables

If the power cord or a cable is damaged, contact Medtronic Navigation™ technical support to obtain
a power cord or schedule a cable replacement.

System disposal

Warning: Some system components contain batteries. Do not recharge or disassemble batteries

that have been removed from system components. Observe local regulations concerning battery
disposal.

Do not dispose of the StealthStation
waste stream. Dispose of this product according to local regulations. See
http://recycling.medtronic.com for instructions on proper disposal of this product.

™

S8 Planning Station or components in the unsorted municipal

27

Troubleshooting

System disposal

28

6 Symbols

Explanation of symbols on package labeling

The following symbols may appear on system equipment, on system packaging, or in this document.

NRTL/MET-Cus Mark indicates compliance to IEC 62368-1 covering electrical safety
requirement for the U.S.

This device complies with the China Compulsory Certification.

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

Consult instructions for use.

Use by date

Batch code

Serial number

Catalog number

Do not sterilize.

Manufacturer

Authorized representative in the European Community

Date of manufacture

Keep dry.

Do not use if package is damaged.

Fragile, handle with care.

29

Symbols

Explanation of symbols on package labeling

Keep upright.

Do not stack.

Power on. Connect to main power.

Power off. Disconnect from main power.

Power on for part of the system

Power off for part of the system

Functional ground

-29 C

-20 F

15 C
59 F

60 C
140 F

30 C
86 F

Storage temperature between 15°C and 30°C (59°F and 86°F)

Shipping temperature between -29°C and 60°C (-20°F and 140°F)

Atmospheric pressure limitation between 101.3 kPa and 69.7 kPa. with an elevation range of
0 m to 3000 m

Humidity limitation between 15% and 90% for shipping

Humidity limitation between 20% and 80% for system operation and storage

Do not disassemble.

USB 2.0 port

Super-speed USB 3.0 port

Protect from heat and radioactive sources.

30

Do not dispose of this product in the unsorted municipal waste stream. Dispose of this
product according to local regulations. See http://recycling.medtronic.com for instructions on
proper disposal of this product.

Chinese Standard (SJ/T11364-2006) Logo: Electronic Information Products Pollution Control
symbol. (The “e” in the logo signifies none of the restricted substances are present above
permitted levels)

China RoHS compliant. Environmental protection use period of 50 years.
Environmental protection use period of 5 years.

Medical device.

Importer.

Symbols

Explanation of symbols on package labeling

31

Medtronic Navigation, Inc.
826 Coal Creek Circle
Louisville, Colorado 80027
USA
Main 720 890 3200
Fax [phone]
Technical Support
U.S. 1 800 595 9709
International 1 720 890 3160
www.medtronic.com
www.manuals.medtronic.com

©2021 Medtronic, Inc

All Rights Reserved

9735904

D00373538 Revision C

00763000479329

2021-12

Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Telephone [phone]

Australia

Medtronic Australasia Pty Ltd
2 Alma Road
Macquarie Park, NSW 2113
Australia
Telephone [phone]

Printed in the USA

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