User Manual English Lidis

Guiding Star's User Manual
version 1.0.0.1
1
Ekliptik d.o.o.
Teslova ulica, 30
1000 Ljubljana
Slovenia (EU)
Ekliptik is the registered trademark of the Ekliptik Company. This publication is not to be copied, repro-
duced or translated into any language without prior written permission of the Ekliptik Company.
GUIDING STAR, LIDIS software, all Ekliptik product logotypes and the Ekliptik logo are trademarks of
Ekliptik Ltd.
Microsoft and Windows are either registered trademarks or trademarks of the Microsoft Corporation in the
U.S.A. and/or other countries.
The IPIX computer, D-cart and battery unit are either registered trademarks or trademarks of Datalux
Corporation in the U.S.A. and/or other countries.
The navigation unit microBIRD is either registered trademark or trademark of the Ascension technology
Corporation in the U.S.A. and/or other countries.
All other third-party product and company names are mentioned for identication purposes only and may
be trademarks of their respective owners.
Note: this equipment has been tested and found to comply with the limits of a class IIb medical device.
Contents
I Warnings and Precautions 6
II Introduction 10
1 Hardware description 12
1.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.1.1 Guiding Star . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.1.1.1 Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
1.1.1.2 Computer unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
1.1.1.3 Extension arm with transmitter . . . . . . . . . . . . . . . . . . . . . . . . 16
1.1.1.4 Navigational unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.1.1.5 Preampliers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
1.1.1.6 Power unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
1.1.2 LIDIS module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
1.1.2.1 Inner probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
1.1.2.2 External probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
1.1.2.3 Calibration accessory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
1.1.2.4 Locating pin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
1.1.2.5 The drilling spacers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
1.2 Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
1.2.1 Assemblying the computer holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
1.2.2 Assemblying the arm with the transmitter . . . . . . . . . . . . . . . . . . . . . . . . 28
1.3 Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
1.3.1 Connections that have to be made before entering the operating theater . . . . . . . 30
1.3.2 Connections that have to be made before switching on the device . . . . . . . . . . . 31
1.3.2.1 If only the LIDIS module is to be used . . . . . . . . . . . . . . . . . . . . . 31
1.4 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
1.4.1 Instructions for sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
1.4.1.1 GUIDING STAR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
1.4.1.2 LIDIS module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
1.5 Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
1.6 Cleaning and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
1.6.1 GUIDING STAR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
1.6.2 LIDIS module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
2 Software description 35
2.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
2.2 Starting the software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
2.3 GUIDING STAR user interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
2.3.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
2.3.2 The elements of the software interface . . . . . . . . . . . . . . . . . . . . . . . . . . 36
2.3.3 The header bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
2.3.4 Main area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
2.3.5 Identifying the current mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
2.4 GUIDING STAR modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
2.4.1 The System check mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
2.4.2 The Welcome mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
2
CONTENTS 3
2.4.3 The "Failure mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

2.5 LIDIS module user interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
2.5.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
2.5.2 The header bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
2.5.3 Main area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
2.5.4 Identifying the software version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
2.5.5 Identifying the current mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
2.5.6 Operating buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
2.5.7 Warning signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
2.5.8 Position of the nail distal holes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
2.5.9 Position of the LIDIS external probe . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
2.6 The LIDIS modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
2.6.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
2.6.2 The Calibration mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
2.6.2.1 Starting the calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
2.6.2.2 Exiting from the LIDIS module . . . . . . . . . . . . . . . . . . . . . . . . . 43
2.6.3 The Find hole mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
2.6.3.1 Locking the hole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
2.6.3.2 Terminating the procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
2.6.4 The Display hole mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
2.6.4.1 When the drill is successful . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
2.6.4.2 When the drill fails . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
3 Procedures 45
3.1 Guiding Star preparations (before entering the operating theater) . . . . . . . . . . . . . . . . 45
3.1.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
3.1.2 Transporting the unit to the operating theater . . . . . . . . . . . . . . . . . . . . . . 45
3.2 Guiding Star preparations (before the surgical procedure) . . . . . . . . . . . . . . . . . . . . 45
3.2.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
3.2.2 Positioning the arm with the transmitter . . . . . . . . . . . . . . . . . . . . . . . . . 45
3.2.3 Connecting the unit to the power supply . . . . . . . . . . . . . . . . . . . . . . . . . 46
3.2.4 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
3.2.5 Connecting the probes and the preampliers . . . . . . . . . . . . . . . . . . . . . . . 46
3.2.6 Positioning the drill machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
3.2.7 Switching on the navigational unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
3.2.8 Switching on the computer unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
3.2.9 Positioning the transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
3.2.10 The warm-up time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
3.3 LIDIS module preparations (before entering the operating theater) . . . . . . . . . . . . . . . 47
3.3.1 Prerequisites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
3.3.2 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
3.4 LIDIS module preparations (before the surgical procedure) . . . . . . . . . . . . . . . . . . . 47
3.4.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
3.4.2 Connection of LIDIS module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
3.4.4 Switching on the computer unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
3.5 LIDIS Clinical procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
3.5.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
3.5.2 Marking the inner probe before inserting the intramedullary nail into the bone . . . . . 48
3.5.3 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
3.5.4 Inserting the inner probe in the nail . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
3.5.5 Locating the distal hole of the nail with the outer probe and xing it . . . . . . . . . . 50
3.5.6 Locating the next hole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
3.6 Post operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
3.6.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
3.6.2 Switching o the units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
3.6.3 Disconnecting the main power supply . . . . . . . . . . . . . . . . . . . . . . . . . . 54
CONTENTS 4
3.6.4 Disconnect the probes and the preampliers . . . . . . . . . . . . . . . . . . . . . . . 54

3.6.5 Disposal or sterilization of the probes and preampliers . . . . . . . . . . . . . . . . . 54
3.6.6 Transporting the cart after use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
4 Support and troubleshooting 55

4.1 Support and assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
4.2 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
4.2.1 Responding to warnings or error messages that appear on the screen . . . . . . . . . . 56
4.2.1.1 The application is displaying old data . . . . . . . . . . . . . . . . . 56
4.2.1.2 A new version of software has been installed. Please switch o the
system and restart it in order to use the new version. The system switches
to the Failure mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
4.2.1.3 The probes are not placed on the calibration stand . . . . . . . . . 56
4.2.1.4 The calibration stand specied in the startup script is not supported
by this version of LIDIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
4.2.1.5 Keep the calibration stand still . . . . . . . . . . . . . . . . . . . . 57
4.2.1.6 Cannot check the rewall's status. Contact assistance . . . . . . . . 57
4.2.1.7 The LIDIS/TOCOS TCP port is not restricted. Contact assistance . 57
4.2.1.8 The LIDIS/TOCOS UDP port is open. Contact assistance . . . . . 57
4.2.1.9 One or more TCP ports are open. Contact assistance . . . . . . . . 57
4.2.1.10 One or more UDP ports are open. Contact assistance . . . . . . . . 57
4.2.1.11 One or more TCP and or UDP ports are open. Contact assistance . 57
4.2.1.12 Keep the probes between 13cm and 40cm from the transmitter . . . 57
4.2.1.13 Please keep the probes below the transmitter . . . . . . . . . . . . 57
4.2.1.14 Remove the inner probe from the nail . . . . . . . . . . . . . . . . 58
4.2.1.15 The two probes are too far from each other. If you have removed the
outer probe because you want to start drilling, please press LOCK HOLE rst 58
4.2.1.16 The system is warming up. Please wait . . . . . . . . . . . . . . . . 58
4.2.1.17 One or more sensors are not connected properly . . . . . . . . . . . 58
4.2.1.18 The sensor n. X is saturated . . . . . . . . . . . . . . . . . . . . . 58

CONTENTS 5
4.2.1.19 The sensor n. X is transmitting bad data . . . . . . . . . . . . . . . 58
4.2.1.20 The transmitter is not running. Is it connected properly to the navi-

gation unit? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
4.2.1.21 There are some problems with the navigation system. Is it connected
properly and switched on? . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
4.2.1.22 The startup script is missing. Please contact the assistance . . . . . 59
4.2.1.23 The system was switched on a long time ago and for security reasons
it needs to be restarted. Soon the system will be automatically switched o 59
4.2.1.24 An external source of noise is disturbing the system. The measures
on the screen could be wrong. . . . . . . . . . . . . . . . . . . . . . . . . 59
4.2.1.25 The probe connected on the port number X has reached the maximum
number of usages and cannot be used. Replace it with a new one. . . . . . 59
4.2.1.26 The probe connected to the connector X can be used one more time
after this procedure. Remember to order a new one. . . . . . . . . . . . . . 59
4.2.1.27 This is the last time that the probe connected to the connector 2 can
be used. Remember to replace it for the next procedure. . . . . . . . . . . 60
4.2.2 Extreme and erratic variation of the probes' position is displayed on the screen . . . . 60
4.2.2.1 The external probe's position appears steeply inclined towards one direction
and, when moved a little, it appears steeply inclined to the opposite direction 60
4.2.2.2 After the calibration the external probe's position is not perfectly aligned and
centered . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
5 Technical data 61
5.1 Storage and Operating Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
5.2 Computer unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
5.3 Power supply unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
5.4 Navigational unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
5.4.1 Navigational unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
5.4.2 Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
5.4.3 Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
5.4.4 Preampliers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
5.5 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Part I
Warnings and Precautions
6
7
Please read carefully this part of the manual that lists the safety warnings before operating on the Guiding
Star medical device.
Warnings
8
9
Do not open the device's units without written permission from Ekliptik d.o.o..
Keep your hands dry when assembling the device.
Use the device only in an operating theater.
Do not open any unit of the system without prior authorization. For trained personnel only!
Risk of high voltage hazard! Fatal injury can occur, especially if the power switch is on and power cord
is plugged in.
Do not use wet hands when working with power supply unit, such as plugging in the power cord etc.
Do not insert any metallic objects (screwdriver, wire, etc.) into any opened slots.
No user-servicable components inside!
If the screen is damaged, DO NOT touch any liquid that may leak from it; this liquid is an irritant. If it
makes contact with your skin, eyes or mouth, immediately rinse the area with running water for at least
15 minutes, and consult a physician if the liquid makes contact with your eyes or mouth.
Do not open or disassemble the guiding star display or electronic unit. You risk electrical shock from
the high voltage inside the casing. Also, if you open the casing, you void your warranty.
When power is applied or the system is running, do not touch exposed electronic components. Contact
with exposed components could cause injury.
The probes, preampliers and transmitters, along with their attached cables and connectors are sensitive
electronic components. To obtain consistent performance and maintain your warranty, treat them
carefully.
Handle the probes, transmitter and preampliers housings carefully. Repeated bending of the cable near
the probes, transmitter or preampliers housings is the most common cause of tracker failure.
Remove the probes, preamplier and transmitter gently from their mounting bracket or holder. Do not
yank or pull on the cable.
Sensors, transmitters and preampliers are likely to be damaged if you carry, throw, or swing them by
their cable or if you let them drop against hard surfaces.
Keep the transmitter, preampliers, probes, and cables away from sources of heat. To extend the life of
the system, shut down the system when not in use.
Electrical and magnetic devices close to the Guiding Star tracking area may disturb the detected probes'
position and inuence the surgical procedure.
Magnetic and/or electrically conductive metal close to the Guiding Star tracking area may disturb the
detected probes' position and inuence the surgical procedure.
Part II
Introduction
10
11
GUIDING STAR
Guiding Star is a technological platform that uses a computer controlled image-guided navigational
system designed for use in various types of surgical procedures; in combination with the LIDIS modules
it enables the bone reduction and easily interlocking cannulated intramedullary nail, with minimal use of
X-Rays.The device contains a navigational unit, which detects the position and the rotation of a series
of sensors located in the LIDIS probes.
LIDIS module
In the LIDIS module, one probe is inserted into the cannulated nail's channel and locked to the nail's
distal holes (the inner probe), while the external probe, which is used outside the bone, enables the
surgeon to locate the hole's position. A computer displays the position of the probes in real time,
allowing the surgeon to easily detect the nail's holes and to lock them.
Chapter 1
Hardware description
1.1 Introduction
1.1.1 Guiding Star
The Guiding Star medical device comprises:
A cart with wheels (4)
A computer unit with integrated display and touch screen (mounted on the cart) (1)
A extension arm with transmitter (mounted on the cart) (5,6)
A navigational unit (mounted on the cart) (2)
A power supply unit (mounted on the cart) (3)
12
CHAPTER 1. HARDWARE DESCRIPTION 13
Figure 1.1: GUIDING STAR Parts description
1. Computer unit with integrated display and touch screen
2. Navigational unit
3. Power supply unit
4. Cart with wheels
5. Extension arm
6. Transmitter
7. Power cable
8. Computer button on/o
9. Navigation unit power and USB connection
10. Navigation unit 4 socket
11. Transmitter cable connected to the navigation unit
12. Power unit no/o button
13. Wheel with brake
14. Computer unit power and USB connection
1.1.1.1 Cart
The cart is mounted on four wheels (2 with brakes) and provides:
a VESA adapter for connecting the computer unit (see on page 16).
two pins for installation of the extension arm (see on page 16). Use only one pin, the one that is more
suitable for the surgical operation.
a hanging plate holding the navigational unit (see on page 17).
supports for the cables.
The cart's two front wheels have a brake system that can be engaged by pushing down a small lever located
over each one of the front wheels. To release the brakes simply pull up the small leverage.
WARNING: Always release the 2 brakes on the Guiding Star cart's front wheels before moving the
unit.
Figure 1.2: Cart
Figure 1.3: Front wheel with brake

Figure 1.4: The pin for the installation of the extension arm
WARNING: Always engage the 2 brakes on the Guiding Star cart's front wheels after the unit has
been placed in position and is ready for a surgical procedure.
1.1.1.2 Computer unit
The computer comes with the operating system and the Guiding Star control software (see on page 35) already
installed and ready to run.
The Guiding Star control software may run LIDIS module or other additional modules.
The computer unit can be mounted on the cart's VESA adapter.
All the interactions with the end user take place via the display and the touch screen integrated in the
computer unit.
Below the screen there are 4 buttons: the rst button on the left switches the computer on/o when kept
pressed for few seconds.
WARNING: To switch o the computer always use the button Switch o displayed by the
software on the bottom-left of the computer screen.
Figure 1.5: Computer unit
1.1.1.3 Extension arm with transmitter
The transmitter is mounted on the end of the extension arm and is used by the navigational unit (see on the
following page) to detect the probes' positions.
The extension has to be installed on one of the pins located on the upper part of the cart (see on page 14).
Before starting using Guiding Star position the transmitter above the volume of interest - sphere diameter
of 40cm.
The probes have to be placed under the transmitter in order to track their positions.
Note that electric and magnetic devices, magnetic metal and electrically conductive metal close to the
Guiding Star tracking area can disturb the detected position of the probes and inuence the surgical procedure.
Figure 1.6: The extension arm with the transmitter
The extension arm with the transmitter
1.1.1.4 Navigational unit
The navigational unit determines the positions of the probes by sending electro magnetic impulses through
the transmitter and transmits the detected positions to the computer unit (see on the preceding page).
The navigational unit is connected to:
1. the computer unit (see on the previous page) by a USB cable
2. to the transmitter mounted on the extension arm (see on the preceding page) and
3. to the preampliers.
Figure 1.7: Navigational unit
WARNING: Turn on the navigational unit 5 minutes before using it. The navigational unit reaches
its highest accuracy 5 minutes after switching on.
1.1.1.5 Preampliers
The preampliers amplify the probes' signals before they reach the navigational unit.
The preamplier has a socket in which the probe's connector is inserted and a plug that has to be connected
to one of the four sensor sockets on the navigational unit.
WARNING: The preampliers with their attached cables and connectors are sensitive electronic
components. To obtain consistent performance and maintain your warranty, treat them carefully.
Figure 1.8: The preamplier
WARNING: The preampliers must be sterilized as described on page 32.
1.1.1.6 Power unit
The power unit is mounted on the cart (see on page 14) and supplies the electrical power to the navigational
(see on the previous page) and computer units (see on page 16).
It has a switch that controls the power to the navigational and computer units to the electrical power;
Note that the power switch does NOT switch on the connected units, but just connects/disconnects them
from the electrical power. Each unit has to be switched on separately.
When the power unit is switched on the LED located on its front emits a green light.
Figure 1.9: Power unit
1.1.2 LIDIS module
The LIDIS module device comprises:
A inner probe (disposable) (15)
A external probe (disposable) (22)
Two preampliers (to be connected to the navigational unit and the LIDIS probes) (29)
A calibration accessory (27)
A locating pin (25)
Two drilling spacers (26)

Figure 1.10: LIDIS module Parts description
Parts of LIDIS module:

15. Inner probe
16. Leaf springs with elliptical caps

17. Clamping sleeve
18. Slider/marker
19. Holder
20. Probe connector
21. Probe connector cable
22. Outer probe
23. Probe connector
24. Probe connector cable
25. Locating pin
26. Drilling spacer
27. Calibration accessory
28. Preamplier connector
29. Preamplier cable
30. Preamplier socket
1.1.2.1 Inner probe
During the surgical operation the inner probe has to be inserted in the intramedullary nail and locked into
the nail's hole in order to determine the position of the nail's distal hole.
The probe has a 1,8 meters long cable with a connector for inserting into the preamplier (see on page 30).
WARNING: The inner probe contains navigational sensors attached to a cable and connector; they
are sensitive electronic components. To obtain consistent performance and maintain your warranty,
treat them carefully.
WARNING: The inner probe must be sterilized as described on page 32.
Figure 1.11: The inner probe

Figure 1.12: The inner probe's leaves and clamping sleeve
Figure 1.13: The inner probe's handle
WARNING: The inner probe for the LIDIS module is a disposable device with a limited lifetime.
The inner probe's handle
1.1.2.2 External probe
During the surgical operation the external probe can be moved over the skin of the leg where the intramedullary
nail has been implanted in order to nd the optimal drilling position.
When in use the external probe's handle should point toward the ground: the references of the hole's
position displayed on the computer screen are calculated assuming that the external probe's handle is pointed
toward the ground.
The probe has a 2.5 meters long cable with a connector for inserting into a preamplier (see on page 30).
WARNING: The external probe contains a navigational sensors with an attached cable and connector;
they are sensitive electronic components. To obtain consistent performance and maintain your
warranty, treat them carefully.
WARNING: The external probe for the LIDIS module is a disposable device with a limited lifetime.
Figure 1.14: The external probe
WARNING: The external probe must be sterilized as described on page 32.
1.1.2.3 Calibration accessory
The calibration accessory is used to calibrate the inner and external probe (see on page 21 and on the preceding
page).
In the calibration process Guiding Star determines the navigational unit's connectors to which the pream-
pliers have been connected and checks for potential errors.
Figure 1.15: The calibration accessory
WARNING: The calibration accessory must be sterilized as described on page 32.

Figure 1.16: The external and inner probe inserted into the calibration accessory
1.1.2.4 Locating pin
The locating pin holds the external probe and is used to x it to the bone, at the optimal position aligned
with the nail's distal holes.
It has a sharp pin(or optionally four pins) that xes it to the bone when hammered in.
Once the locating pin is xed in position then the external probe can be replaced by a drilling spacer which
drives the drilling machine through the distal holes.
The drilling spacer can be removed to leave room for the screw, driven into position through the locating
pin's channel.
Figure 1.17: The locating pin
WARNING: The locating pin must be sterilized as described on page 32.
1.1.2.5 The drilling spacers
Guiding Star comes with two drilling spacers (with inner diameters of 3.4mm and 4.4mm), which have a
dierent channel diameters: choose the right spacer before starting the surgical operation, according to the
radius of the drill bit. The drilling spacer is inserted into the locating pin after it has been xed to the bone
and the external probe has been removed. Its narrow channel orients the drilling machine through the distal
holes found by the external probe.
Figure 1.18: The drilling spacer
WARNING: The drilling spacers must be sterilized as described on page 32.
1.2 Assembly
1.2.1 Assemblying the computer holder
This procedure explains how to mount the computer holder on the top of the cart:
Figure 1.19: The cart work surface, on which the computer holder will be installed
Figure 1.20: Insert the USB and DC power cables from below through the left hole of the cart work surface
Figure 1.21: Place the plastic base and clip it into the work surface
Figure 1.22: Place the support into the plastic base. Insert the cables in the left channel of the support
Figure 1.23: Secure the support from the lower side of the work surface by using four 10mm pan head screws
Figure 1.24: Slide the black plastic cover into the left channel of the support
Figure 1.25: Place the white plastic cover on the top of the support and secure it using two cross screws
Figure 1.26: Place the black cable holder on the cables and secure it to the white plastic cover
Figure 1.27: Secure the computer unit to the support using four 4mm pan head screws. Torx security pan
head screws can be used in two of the 4 screws positions.
1.2.2 Assemblying the arm with the transmitter
Figure 1.28: Parts of moving arm

Figure 1.29: Arm assembly
1. Place the metal support (5.1) on one of the pins located on the left or right side of the cart
2. Place the extension (5.2 ) on the top of the metal support (5.1)
3. Place the extension (5.3) on the top of the extension (5.2)
4. Secure the handle (5.7) to the transmitter holder (5.4) using two cross head screws (5.8)
5. Place the transmitter cable into the channels on the bottom of the extensions (5.2) and (5.3)
Figure 1.30: Cable position
1.3 Connections
1.3.1 Connections that have to be made before entering the operating theater
The computer unit ( on page 16) and the navigational unit ( on page 17) have to be connected with the
respective power cords.
The power cord with the 3-hole plug has to be connected to the socket on the back of the navigational
unit.
The power cord has to be screwed to the power socket at the bottom of the computer unit.
The computer has to be connected to the navigational unit with the USB cable supplied with the Guiding
Star:
connect one end of the USB cable to one of the two USB sockets on the bottom of the computer unit.
connect the other end of the cable to the USB socket on the back of the navigational unit.
1.3.2 Connections that have to be made before switching on the device
Connect the power unit with the power cord plug supplied with the Guiding Star to an easily accessible
220V/50hz socket outlet.
The sterilized preampliers and probes have to be connected to the navigational unit before it is switched
on. After the navigational unit has been switched on with the probes connected correctly, it is then possible
to replace the probes with new ones without switching the navigational unit o and on.
WARNING: Only the probes can be replaced while the navigational unit is switched on. The
preampliers must NOT be replaced while the navigational unit is switched on.
1.3.2.1 If only the LIDIS module is to be used
1. Connect the two preampliers to any of the 4 sockets on the front of the navigational unit.
2. Push the preampliers' connectors into the sockets on the front of the navigation unit until they click.
Connect the LIDIS inner probe to one preamplier, and the LIDIS external probe to the other preamplier:
1. Gently insert the probe's connector into the preamplier's socket until it touches the bottom of the
socket.
2. Gently rotate the probe's connector until you can push it further into the socket until it clicks.
Figure 1.31: Sockets for the preampliers connections
Figure 1.32: The preamplier's connector
Figure 1.33: The preamplier's socket (connect the probe here)

Figure 1.34: The probe's connector
1.4 Sterilization
1.4.1 Instructions for sterilization
All the probes and preamplier have to be sterilized with plasma before they can be used in the
operating theater. Other accessories can be sterilized using other sterilization method.
Do not use autoclave sterilization for probes and preampliers!
Always sterilize more probes, tools and preampliers than needed directly: this will allow the surgeon
to carry on using the system in the event that one of the sterilized accessories comes in contact
with a non sterile object or person or reaches its usage limit.
1.4.1.1 GUIDING STAR
Prior to the operation, cover the cart (including the computer unit, the navigational system, the extension
arm and the power supply unit) with a set of sterile sheets for x-ray machines, min. size 225 x 90 cm.
If the sterile sheets are too short, you can cover the navigational unit separately with an adhesive waterproof
sterile compress.
1.4.1.2 LIDIS module
If the LIDIS module is to used, then the following LIDIS' parts have to be sterilized with plasma before use in
the operating theater:
2 LIDIS inner probes (nr.14) (1 as a spare),
2 LIDIS external probes (1 as a spare),
3 Preampliers (1 as a spare).
The following LIDIS' parts have to be sterilized with either plasma or another sterilization method before use
in the operating theater:
2 Calibration tools (1 as a spare),
2 Locating pins (1 as a spare),
2 Drilling adapters (1 as a spare). LIDIS is supplied with 2 types of drilling adapters: choose the one
that matches the drill used in the operating theater.
Place all the accessories that have to be sterilized in their corresponding placeholder in the sterilization box.
The box has several placeholders, each designed to accommodate a probe or accessory. Pay special attention
to the inner probe with the vinyl coat which must be completely stretched out and inserted in the slots. Make
sure that the external probe is inserted in a slot, with the out-cable rolled into a coil and inserted in the
appropriate slot.
Place the sterilization box in a plasma chamber and start the sterilization cycle.
After the sterilization update your documents with the number of times each probe has been
used; each probe can be used for a maximum of 15 surgical operations.
To sterilize the LIDIS module without a supplied sterilization box, use the standard procedure used as
described above.
1.5 Transportation
The Guiding Star has a 4 wheeled cart that allows to move it around. The cart's movement can be blocked
by engaging two brakes mounted on the cart's front wheels.
WARNING: Always release the 2 brakes on the Guiding Star cart's front wheels before moving the
unit. To engage the brakes push down the small leverages mounted on the back wheels, while to release the
brakes pull the leverages up.
WARNING: Always engage the 2 brakes on the Guiding Star cart's front wheels after the unit has
been placed and is ready for a surgical procedure.
Figure 1.35: How to fold the arm
WARNING: Always fold the arm with the transmitter before moving the Guiding Star cart as shown
in the following gure:
1.6 Cleaning and maintenance

1.6.1 GUIDING STAR
Use towels saturated in cleansing solution normally used for cleaning medical instruments to clean the Guiding
Star system (transmitter, navigation unit, cart, arm and the power unit). Do not dip the Guiding Star into
any liquid. Gently wipe the computer screen with a soft cloth. Do not push onto the screen with hard or sharp
objects to avoid any damage.
Check cables of the Guiding Star system regularly for any strains or cuts in the insulation.
Protect cables or any other parts from squeezing.
Do not walk on plugs and cables.
Check all connectors for damaged pins.

Check all plugs and sockets for good contacts.
WARNING: Applying pressure to the screen can damage the screen.
1.6.2 LIDIS module
Use towels saturated in cleansing solution for cleaning the LIDIS module(probes, preampliers, accessories and
cables). Do not dip, probes or preampliers into any liquid.
The probes contain sensors which are sensitive measuring instruments. Handle them with care !
Do not bend probe or preamplier cables.
Protect cables or any other parts from squeezing.
Do not walk on plugs and cables.
Do not drop probes or preampliers on hard surfaces.
Check component connectors for damaged pins.
Check all plugs and sockets for good contacts.

Chapter 2
Software description
2.1 Introduction
The Guiding Star software with LIDIS module comes preinstalled on the Guiding Star device and starts
automatically when the user logs in as a Guiding Star user.
The software displays a full screen graphical interface, with which the user can interact by touching the
buttons on the touch screen; no mouse or other input devices are required to operate the device.
2.2 Starting the software

1. In order to start the Guiding Star software, switch on the computer by keeping the power button pressed.
2. When the login screen appears, touch the Guiding Star logo to log in as a Guiding Star user.
3. The software will start automatically and it will also switch o the computer when exiting.
2.3 GUIDING STAR user interface

2.3.1 Introduction
The Guiding Star software displays a full screen graphical user interface.
The software buttons are located on the lower part of the screen: the user interacts with the device by
touching the buttons.
35
CHAPTER 2. SOFTWARE DESCRIPTION 36
2.3.2 The elements of the software interface
Figure 2.1: The elements of the software interface
2.3.3 The header bar
The header bar is the black area located on the upper part of the screen
It displays the software's name (F), the active mode (E) as described in the section GUIDING STAR
modes" (2.6), the software version (G) and a description of the mode (H).
It is important to know the version of the software that you are using if you need to contact the customer
service or if you are having a problem with a new modules part (e.g.: a new type of probe).
The software version is always displayed in the upper right corner of the screen (G) and is composed by
numbers separated by a dot.
2.3.4 Main area
The main area has tree active buttons (A) for entering the TOCOS module, (B) for entering the LIDIS module,
(D) for switching o the system and identication icon (C) for showing the active connections.
2.3.5 Identifying the current mode
Guiding Star runs in one of the following modes:
1. System check
2. Welcome
3. Failure
The active mode is displayed in the upper part of the screen (E). See on page 41 for more information regarding
the Guiding Star modes.
2.4 GUIDING STAR modes

2.4.1 The System check mode
The System check mode is activated as soon as Guiding Star starts; it performs a check of the system
hardware.
During a system check the user cannot perform any operation; Guiding Star will switch automatically to
Welcome or to Failure (see on page ??) without any user intervention. If all the components are working
Guiding Star then switches to the Welcome mode. Otherwise, it will switch to the Failure mode.
Figure 2.2: System check mode
2.4.2 The Welcome mode
From the Welcome mode you can select two diferent modules:
GUIDING STAR/LIDIS
GUIDING STAR/TOCOS
When Welcome mode appears, press the button GUIDING STAR LIDIS or GUIDING STAR TOCOS.
To switch o the GUIDING STAR keep the Terminate button pressed until the progress bar reaches
its maximum point, then remove the nger from the button. The system will initiate the exit procedure and
shut down the computer unit.
Figure 2.3: "Welcome mode
2.4.3 The "Failure mode
If Failure mode occurs, check that navigation unit is turned on. (green LED light on navigation unit).
Warning: Before checking the cable connections, turn navigation unit o.
1. Ensure that all connectors are rmly attached and cables are not twisted.
2. The cable connection between navigation unit and computer unit.
3. The cable connection between navigation unit and transmitter.

4. If the navigation unit is turned o for more than 10 seconds, then turn it back on.
The system will recheck the whole system, when user presses Check Again. If Failure mode is not resolved
1. Switch o the system (Computer unit and navigation unit).
2. Turn on computer unit.
3. Turn on navigation unit.
4. Login as Guiding star user.
If Failure state is still not resolved, user should contact technical assistance.
GUIDING STAR switches to this mode Failure whenever a severe failure in the system has been detected.
After the cause of the failure has been remedied (see Warning) the user can press Check again button
to start from the mode Welcome (see on page 48).
The user can also switch o Guiding Star system by pressing rheSwitch o button.
Figure 2.4: The Failure mode
2.5 LIDIS module user interface

2.5.1 Introduction
The LIDIS module software displays a full screen graphical user interface. The software buttons are located
on the lower part of the screen: the user interacts with the device by touching the buttons.
Figure 2.5: The elements of the software interface
2.5.2 The header bar
The header bar is the black area located on the upper part of the screen
It displays the software's name (see A on page 36), the active mode (see B on page 36) as described in
the section LIDIS modes" (2.6), the software version (see C on page 36) and a description of the mode (see
D on page 36).
2.5.3 Main area
The main area has two active buttons at the bottom of the window for manipulating the procedure (see E,F
on page 36), a static circle in the middle of the screen to represent the distal hole(see G on page 36), an active
series of squares to represent the external probe with the smaller cross (see H on page 36) and a warning
window to dispaly the warnings messages (I on the image).
2.5.4 Identifying the software version
It is important to know the version of the software that you are using if you need to contact the customer
service or if you are having a problem with a new module part (e.g.: a new type of probe).
The software version is always displayed in the upper right corner of the screen (see C see mage on page 36)
and is composed by numbers separated by a dot.
2.5.5 Identifying the current mode
LIDIS module runs in one of the following modes:
1. Calibration
2. Find hole
3. Display hole
4. Failure
The active mode is displayed in the upper part of the screen (B on the image on page 36). See on the following
page for more information regarding the LIDIS modes.
2.5.6 Operating buttons
The buttons are located at the bottom of the screen:
the button on the left (see E on page 36) is used to terminate an operation (e.g.: to terminate a
procedure or switch o the system),
the button on the right (see F on page 36) is used to initiate an operation or acknowledge its success
(e.g.: to start the calibration, to acknowledge a successful drilling).
To activate a button just keep your nger on it until the progress reaches its maximum position (the progress
bar appears over a button when the user touches it).
The progress bar looks like this at its minimum and like this at its maximum.
If you touch the wrong button just remove your nger it before the progress bar reaches its maximum: if
the bar has already reached its maximum, move the nger outside the button's area (keeping the nger on
the screen) until the progress bar disappears and then remove the nger.
2.5.7 Warning signals
Warnings appear immediately below the header bar (part I on the image on page 36) but only when they are
activated.
2.5.8 Position of the nail distal holes
When the system is in "Find hole or Display hole mode then the position of the distal hole is indicated by
a circle in the middle of the screen (part G on the image on page 36). The hole's position is detected by the
inner probe while it is inserted in the intramedullary nail and locked into the distal hole.
Figure 2.6: Find hole
2.5.9 Position of the LIDIS external probe
When the system is in "Find hole or Display hole mode then the position of the LIDIS external probe in
relation to that of the distal hole is represented by a series of squares (part H on the image on page 36). The
squares display the position of the LIDIS external probe and its inclination towards the nail's distal holes. The
space reference (up, down, left, right) is based on the LIDIS external probe with its handle pointing toward
the ground. The software clearly displays the location of the external probe as small squares and the location
of the hole as a circle. When the smaller cross is aligned with the larger cross, when the smallest square
circumscribes the circle and the small squares do not overlap each other, the user has located the correct
drilling position.
Figure 2.7: Display hole
2.6 The LIDIS modes

2.6.1 Introduction
After LIDIS starts it can be in one of the following modes:
1. Calibration
2. Find hole
3. Display hole
4. Failure
Only information that is relevant to the active mode is displayed on the screen. Only one mode can be active
at any time.
The following Figure represents the LIDIS modes and the causes that force LIDIS to switch from one mode
to another one.
Figure 2.8: State chart
The arrows SYSTEM_ERROR and SYSTEM_OK represent 2 events that are not caused by the user but
happen when LIDIS detects a failure or a healthy system.
All the others arrows represent events caused by the user pressing a button on the touch screen.
A more detailed description of the modes and the buttons that cause the switch between them follows.
2.6.2 The Calibration mode
When the Calibration mode is activated, LIDIS module is then waiting for the user to insert the probes in
the calibration stand and to start the calibration.
When the user starts the calibration, the LIDIS module calibrates the sensors in the LIDIS probes and, if
the operation is successful, it switches to the Find hole mode; otherwise it stays in the Calibration mode.
While the Calibration mode is activated the user can also terminate the LIDIS module by pressing the
Terminate button.
Figure 2.9: The system is ready for calibration
2.6.2.1 Starting the calibration
1. Insert the inner and the outer probes in the calibration tool as indicated on the above gure.
2. Position the calibration tool 13 to 40 centimeters (5 to 15 inches) below the transmitter.
3. Keep the Calibrate button pressed until the progress bar reaches its maximum point, then remove the
nger from the button.
4. When the calibration procedure terminates, LIDIS switches to the Find hole mode (see on this page),
or stays in the Calibration mode if an error is detected.
2.6.2.2 Exiting from the LIDIS module
To switch o the LIDIS module keep the Terminate button pressed until the progress bar reaches its
maximum point, then remove the nger from the button.The system will initiate the exit procedure from
LIDIS module and activate Welcome mode.
2.6.3 The Find hole mode
When this mode is activated the LIDIS module displays the positions of the probes in real time, which enables
the user to nd the position of the nail's distal holes.
When the hole has been found, the user switches to the Display hole mode by pressing the Lock hole
button (see on the next page).
At this point the user can also terminate the procedure and return to the Calibration mode (see on
page 48).
Figure 2.10: The system displaying the positions of the probes

2.6.3.1 Locking the hole
When the distal hole has been located with the external probe, the user has to lock its position. This operation
is necessary because the located inner probe has to be unlocked from the located distal hole.
The LIDIS inner probe is removed from the distal hole in order to avoid moving it while the LIDIS locating
pin is hammered into place and, thus avoid the risk of drilling through.
To lock the position of the hole keep the button Lock hole pressed until the progress bar that appears
over it reaches its maximum.
The system will enter into the Display hole mode (see 2.6.4).
After the position of the hole has been locked the inner probe can be removed without interfering with the
detected position of the distal hole, which will continue to be displayed correctly
2.6.3.2 Terminating the procedure
When all the distal holes have been drilled through or when the system needs a new calibration, the procedure
has to be terminated by pressing the Terminate button.
The system will switch to the Calibration mode (see 3.5.3 on page 48), from which is possible to perform
a new calibration or exit the LIDIS module.
2.6.4 The Display hole mode
When this mode is activated, LIDIS module displays the position of the outer probe in real time, while displaying
the position of the inner probe at the time of switching from the Find hole mode (see on the previous page).
This allows the user to remove the LIDIS inner probe from the nail without losing the position of the distal
hole.
Once the hole has been drilled, the user can switch the LIDIS module back to the Find hole mode or to
the Calibration mode (see on page 48) if the drill has failed.
Figure 2.11: The position of the inner probe has been locked
2.6.4.1 When the drill is successful
When the drill is successful, press the Drill successful button.

The system will go into the Find hole mode (see 2.6.3 on the previous page), allowing another distal hole
to be found.
2.6.4.2 When the drill fails
If the drill fails press the Drill failed button.

The system will go into the Calibration mode (see 3.5.3 on page 48).
Chapter 3
Procedures
3.1 Guiding Star preparations (before entering the operating the-
ater)
3.1.1 Introduction
Before Guiding Star can be safely used in the operating theater, the instructions in this section must be
followed carefully.
3.1.2 Transporting the unit to the operating theater
See information 1.5
3.2 Guiding Star preparations (before the surgical procedure)

3.2.1 Introduction
This chapter describes the tasks that have to be performed immediately before performing a surgical proce-
dure with the Guiding Star. Keep in mind that this procedure involves opening the sterile packages
containing the inner and external probes.
3.2.2 Positioning the arm with the transmitter
The arm is composed of an stainless tube (5.1), which raises the arm's height from the ground, and a plastic
foldable (5.2, 5.3) arm on which the transmitter is mounted.
The arm can be mounted on the left or on the right side of the cart: before starting the surgical procedure
you have to plan the position of the arm, considering that the transmitter has to be positioned close to the
body's part on which the intramedullary nail will be inserted. User should consider the optimal position of the
arm.
If the arm has to be repositioned:
1. Unplug the stainless tube (5.1) on which the arm is mounted from the pin holding it.
2. Plug the stainless tube (5.1) with the arm into one of the pins located on the front of the cart, close to
the computer unit. Select the pin carefully according to the position of the cart relative to the position
of the patient.
3. Check that the stainless tube (5.1) is fully inserted on the pin on the cart and that the plastic foldable
arm (5.2, 5.3) is fully inserted on the stainless tube.
4. Connect the transmitter's cable and navigation unit. Secure the connection with the screws located on
the transmitter's connector.
45
CHAPTER 3. PROCEDURES 46
3.2.3 Connecting the unit to the power supply
1. Check that the power button located on the front of the power unit is in the OFF position.
2. Check that the power button located on the back of the navigational unit is in the OFF position.
3. Connect the power cable located on the back of the power unit to an easily accessible 220V/50hz power
socket outlet. The socket outlet has to be protected by an uninterruptible power source.
4. Switch on the power unit using the switch located next to the socket for the power cord: the LED
located on the front of the power unit must light.
3.2.4 Sterilization
Cover the cart (including the computer unit, the navigational system, the extension arm and the power supply
unit) with a sterile set of sheets for x-ray machines, min. size 225 x 90 cm. If the sterile set for the x-ray
machine is too short, cover the navigational unit separatly with an adhesive waterproof sterile compress.
3.2.5 Connecting the probes and the preampliers
Connect two, three or four preampliers to connectors on the navigation unit. The number of preampliers
depends on the modules that will be used during the surgical operation.
Connect two preampliers if only the module LIDIS (distal interlocking) will be used.
3.2.6 Positioning the drill machine
WARNING: this recomendation helps to minimize the risk of drilling through the bone while the
inner probe is still locked into the distal hole. Drilling through the bone while the inner probe is
still locked may damage the probe and CAN INJURE THE PATIENT. The drilling machine can cause
interference with electro-magnetic eld of the navigation unit. System could detect such interference and will
warn the user that external source of noise is disturbing the system.
3.2.7 Switching on the navigational unit
WARNING: The navigational unit must be switched on AFTER the preampliers and the probes
have been connected (see on the current page) and BEFORE switching on the computer unit (see
on page 48).
Switch on the navigational unit with the button located on the back of the navigational unit.
3.2.8 Switching on the computer unit
1. Press the power button on the front of the computer unit until the computer switches on
2. When the login screen appears then touch the Guiding Star user on the computer screen.
3. Do not touch the screen again until Guiding Star enters into the Welcome mode
3.2.9 Positioning the transmitter
WARNING: Electric and magnetic devices, magnetic metals and electrically conductive metals close
to the Guiding Star tracking area may inuence the probes' detected positions impairing the surgical
procedure.
Move the folding arm so that the transmitter is located over the fractured bone. The transmitter is able
to detect the positions of the probes only when they are located below it. The range of the transmitter is
about 40 centimeters.
3.2.10 The warm-up time
The navigational system achieves sucient accuracy 5 minutes after being switched on. During this time the
software will display a warning on the screen, but will still allow the system to be used.
3.3 LIDIS module preparations (before entering the operating

theater)
3.3.1 Prerequisites
Before attempting the use of the LIDIS module during a surgical operation, check the following
conditions. The following limitations to the use of LIDIS module have to be considered:
Only the distal holes of CANNULATED intramedullary nails can be located.
The cannulated intramedullary nail with its jig adapter for proximal holes has to be compatible with the
Guiding Star's inner probe.
The drilling spacers have to be compatible with the drill tools.
The locating pin has to be compatible with the screws used to x the nail.
The maximum number of surgical operations that can be performed with each probe is 15. The software
will not allow use of a probe that has reached its maximum usage.
3.3.2 Sterilization
See instructions for sterilization 1.4
3.4 LIDIS module preparations (before the surgical procedure)

3.4.1 Introduction
Following the instructions in this chapter you will be able to prepair the LIDIS module for surgical procedure
Before starting:
The navigational unit and the computer unit must be switched o.
The Guiding Star has to be placed on the proper position for the surgical procedure and connected to
the power.
3.4.2 Connection of LIDIS module
Unpack the sterile plastic bag or open the sterilization box with the sterile LIDIS module and take out the
preampliers and probes. Connect them as follow:
1. Connect two preampliers to any of the 4 sockets on the front of the navigational unit.
2. Push the preampliers' connectors into the sockets on the front of the navigation unit until they click.
Connect the LIDIS inner probe to one preamplier, and the LIDIS external probe to the second preamplier:
1. Gently insert the each probe's connector into the its preamplier's socket until it touches the bottom of
the socket.
2. Gently rotate the probe's connector until you can push it further into the socket.
3. Push the probe's connector into the socket until it clicks.
WARNING: The navigational unit must be switched on AFTER the preampliers and the probes
have been connected (see on the previous page) and BEFORE switching on the computer unit (see
on the following page).
3.4.4 Switching on the computer unit
1. Press the power button on the front of the computer unit until the computer switches on.
2. When the login screen appears then touch the Guiding Star user on the computer's screen.
3. Do not touch the screen again until Guiding Star enters into the Welcome mode.
4. Press the button Guiding Star/LIDIS to go into the "Calibration mode.
3.5 LIDIS Clinical procedures

3.5.1 Introduction
These procedures enables the user to lock the distal holes on the intramedullary nail.
Before starting:
The navigational unit and the computer unit must be switched on.
The LIDIS module software has to be in the Calibration mode.
3.5.2 Marking the inner probe before inserting the intramedullary nail into the
bone
Before inserting the intramedullary nail into the bone:
1. Screw the jig adapter for drilling the proximal holes to the intramedullary nail.
2. Slide the small claming sleeve (17 1.1.2) down the inner probe until it covers the spring spherical blobs
(16 1.1.2) on the ends of the leaves.
3. Rotate the inner probe along its longitudinal axe so the spherical blobs are oriented at 90 degrees to the
proximal holes of the nail.
4. Insert the inner probe in the channel of the jig adapter used to drill the proximal holes.
5. Push the probe forward along the channel until its distal end reaches the most distant holes.
6. Rotate the inner probe until it locks in the distal hole of the nail.
7. Move the marker (18 see 1.1.2) on the inner probe until it touches the jig adapter screwed into the nail.
8. Unlock the inner probe and lock it into the next distal holes.
9. Note the distance from the marker (18 see 1.1.2) to the spacer used to drill the proximal holes and write
it down.
3.5.3 Calibration
When the system is ready, the Calibration mode is automatically enabled: if there are warnings displayed on
the screen then resolve the cause of the warnings before continuing.
The following image appears on the LCD screen:
Figure 3.1: The system is ready for calibration

1. Insert the external probe into the calibration accessory and lock it into position.
2. Insert the inner probe into the calibration accessory and lock it into position. Pay attention to the
position of the probe in the calibration accessory: it has to be rmly locked in the holes located in the
proximity of the slot for the outer probe.
3. Place the calibration accessory under the transmitter, about 20 cm (between 13 and 40 cm) from the
transmitter.
4. Press the Calibrate button on the computer screen.
5. Keep the calibration tool still under the transmitter and wait for the calibration to complete.
6. When the calibration has been completed successfully, go to the next phase (Inserting the inner probe
in the nail on the current page).
If the calibration fails, the system will either switch to the Failure mode if severe error is detected (See 2.4.3),
or stay in the Calibration mode. If the latter, then:
the probes are not placed correctly in the calibration stand: check the position of the probes and repeat
the operation; or
the calibration accessory was shaking during the calibration: repeat the operation keeping the calibration
accessory still; or
the calibration accessory was too far from or too close to the transmitter: keep the calibration accessory
between 13 and 40 centimeters from the transmitter and repeat the operation; or
an external source of noise prevented successful calibration: remove the source of noise and repeat the
operation.
3.5.4 Inserting the inner probe in the nail
This operation has to be performed after the calibration (see on the preceding page).
1. Once the nail has been inserted into the bone, use a metal wire to clear the bone's channel from
spongiosis that could block the inner probe.
2. Slide the small clamping sleeve (17) onto the inner probe until it covers the spherical blobs on the spring
leaves.
3. With one hand hold the handle (19) end of the inner probe and with the other hand hold the proximal
end of the inner probe.
4. Rotate the inner probe along its longitudinal axe so that the spherical blobs (16) are at 90 degrees to
the proximal holes of the nail.
5. Insert the inner probe in the channel of the jig adapter used for drilling the proximal holes.
6. Push the probe forward along the channel until the marker (18) of the probe impacts on the jig adapter
(see on the previous page).
8. Check whether the inner probe is locked into the holes by trying to move it backwards and forwards: if
the probe does not move, then it is safely locked into the distal hole.
3.5.5 Locating the distal hole of the nail with the outer probe and xing it
After the inner probe has been locked into the nail's distal hole (see on the preceding page) then use the outer
probe to locate the hole into which the inner probe is locked.
The LIDIS module software has to be in the mode Find hole (see on page 43) and the following image
should be displayed on the screen:
Figure 3.2: Find hole
The positions of the squares depend on the position of the external probe in relation to the position of the
inner probe.
The static circle in the middle of the screen represents the position of the hole into which the inner probe
is locked, while the squares represent the position of the external probe.
1. Insert the external probe(22) into the locating pin(25)
2. Move the locating pin(25) with the external probe(22) over the skin
3. Move the external probe near the approximate axis of the distal holes; when it is close to the axis of the
distal hole, its position can be seen on the computer screen
4. Adjust the inclination of the external probe so that all the squares are perfectly concentric
5. Move the external probe until the squares circumscribe the circle. The following gures show how the
positions of the probes are represented on the computer screen and the actions required to align the
external probe with the distal holes.
Figure 3.3: The external probe has to be moved to the right

Figure 3.4: The external probe has to be moved to the left
Figure 3.5: The external probe has to be moved up
Figure 3.6: The external probe has to be moved down
Figure 3.7: The external probe has to be tilted to the right
6. When the squares are aligned with each other and circumscribe the circle, mark that spot and do the
incision.
7. Enter with locating pin through the incision towards the bone.
8. On the bone ne tune the alignment of the squares with the circle
Figure 3.8: The external probe has to be tilted to the left
Figure 3.9: The external probe has to be tilted down
Figure 3.10: The external probe has to be tilted up

9. Now release the external probe from the locating pin (slightly rotate the external probe to unlock it).
10. Press the Lock Hole button.
11. The message Remove the inner probe will appear.
12. Unlock the inner probe from the distal hole by rotating it slightly, then move the probe backwards until
the message Remove the inner probe disappears.
13. Gently hammer the locating pin to the bone.
14. Check again the position of the external probe on the screen. When correctly oriented, as above, remove
completely the external probe from the locating pin, being careful not to move the locating pin.
15. Hammer the locating pin rmly into the bone.
16. Insert the appropriate drilling adapter (26.) into the locating pin.
17. Drill through into the bone.
18. Remove the drill and drilling adapter from the locating pin.
19. Insert the screw through the locating pin and screw it to the nail and bone.
20. If the drilling was successful press the Drill successful button and go to the next phase (Locating the
next hole on this page).
21. If the drilling has failed press the Drill failed button to return to the Calibration (See on page 48)
3.5.6 Locating the next hole
1. Move the inner probe (15) until the distance between its marker (18) and the jig adapter used for drilling
the proximal holes is the same as the measurement made in the last step of 3.5.2 on page 48.
3. Check whether the inner probe is locked into the holes by trying to move it backward and forward: if
the probe does not move then it is safely locked into the distal hole.
4. Repeat the procedure described in 3.5.5 on page 50.
WARNING: The navigational unit must be switched on AFTER the preampliers and the probes have
been connected (see on page 46) and BEFORE switching on the computer unit (see on page 48).
3.6 Post operation

3.6.1 Introduction
Follow the instructions in this chapter to disconnect the Guiding Star medical device and prepare it for storage
or transportation.
3.6.2 Switching o the units
1. You can switch o the unit when you are in "Welcome mode.
2. Press the Switch o button to switch o the unit.
3. The computer will start the shut down sequence and after few seconds it will switch o automatically.
4. Switch o the navigational unit.
5. Switch o the Guiding Star power unit.

3.6.3 Disconnecting the main power supply
Remove the power cord's plug from the power socket, and roll-up the power cord.
3.6.4 Disconnect the probes and the preampliers
1. Remove the probe connectors from the preamplier sockets.
2. Remove the preamplier connectors from the navigation unit sockets.
3.6.5 Disposal or sterilization of the probes and preampliers
1. If the probes are to be disposed of, then use the standard procedure for displosable medical devices.
2. Preampliers are NOT disposable.
3. If the probes are not to be disposed of, then use standard procedures for cleaning sensitive electronic
medical devices.
4. Use the sterilization procedure described under the chapter Sterilization 1.4.
3.6.6 Transporting the cart after use
See information 1.5.
1. Disconnect the Guiding Star's power cord from the power socket.
2. Fold the power cord on the cart's handles.
3. Fold the arm with the transmitter as shown 1.5.
4. Release the brakes located on the cart's rear wheels.
5. Transport the unit to a safe place.

Chapter 4
Support and troubleshooting

4.1 Support and assistance
Support and assistance for the Guiding Star system is supplied directly by the local distributor.
Additionally, inquiries and help requests can be sent to Ekliptik d.o.o., the producer of the Guiding Star
system.
You can contact Ekliptik at the following addresses:
Website:
http://ekliptik.si
Click on Support to le a support request
Mail:
Ekliptik d.o.o.
Teslova, 30
1000 Ljubljana
Slovenia
Telephone:
+386 (0) 1 477 66 31
Fax
+386 (0) 1 477 66 32
Email:
info@ekliptik.si
When submitting a request for support you should report the following data:
The serial number of your Guiding Star system
The serial numbers of the probes
The problem or the information you need. When reporting a problem please be specic:
Try to identify the faulty part (check the LED status on the power unit, on the navigational unit
and on the computer unit)
Report any error message or warning that appears on the computer unit's screen
Name the navigational unit's sockets used to connect the probes
55
CHAPTER 4. SUPPORT AND TROUBLESHOOTING 56
4.2 Troubleshooting
4.2.1 Responding to warnings or error messages that appear on the screen
4.2.1.1 The application is displaying old data
This message indicates that the position displayed on the screen is not in real time. This may be a temporary
situation due to an overload of the computer unit, or may represent a more serious problem due to a malfunction
or a disconnected connector.
If the message is temporary, and appears very rarely and only for few seconds, then the problem is related
to a temporary overload of the computer unit (e.g.: the system generated a new log le after the old
log le exceeded its maximum allowed size and the antivirus checked the archived logs). This does not
represent a serious threat.
If the message appears frequently and disturbs the clinical procedure then the problem may be related to
frequently overload of the computer unit. Contact Support as this may indicate an error in the system.
If the message appears on the screen and does not disappear, the problem is related to a malfunction
or a disconnected probe:
Check that the probes and the preampliers are properly connected. If not, then restore the
connections correctly
Note that the connection of new probes requires a switch-o/switch-on cycle only if the preamplier
socket was not previously connected to a probe, while the connection of a new preampliers always
requires a switch-o/switch-on cycle.
Check if the navigational unit is switched on and properly connected to the computer unit.
4.2.1.2 A new version of software has been installed. Please switch o the system and
restart it in order to use the new version. The system switches to the Failure mode
This message appears when the software has just been updated. Switch o the system and then switch it on
again to solve the problem.
4.2.1.3 The probes are not placed on the calibration stand
This message indicates that the inner probe and the external probe are not placed correctly on the calibration
stand, or that a magnetic or electrically conductive metal is near the Guiding Star's tracking area.
Place the inner probe and the external probe in the calibration stand, move the calibration stand under
the transmitter and click on the Calibrate button that appears at the bottom-right hand corner of the
computer unit's screen.
If the problem persists then a magnetic or electrically conductive metal or an electrical device is near
the Guiding Star's tracking area: identify the metal or device that is interfering with Guiding Star and
move the transmitter or the noise source until the problem disappears.
4.2.1.4 The calibration stand specied in the startup script is not supported by this version
of LIDIS
This message indicates an error in the system conguration. Contact assistance.

4.2.1.5 Keep the calibration stand still
The calibration stand has not been kept still during the calibration procedure, or a source of electromagnetic
noise is interfering with the Guiding Star system.
4.2.1.6 Cannot check the rewall's status. Contact assistance
The system is not congured correctly. Contact Assistance.
4.2.1.7 The LIDIS/TOCOS TCP port is not restricted. Contact assistance
4.2.1.8 The LIDIS/TOCOS UDP port is open. Contact assistance
4.2.1.9 One or more TCP ports are open. Contact assistance
4.2.1.10 One or more UDP ports are open. Contact assistance
4.2.1.11 One or more TCP and or UDP ports are open. Contact assistance
4.2.1.12 Keep the probes between 13cm and 40cm from the transmitter
Guiding Star is able to track the probes' position only when they are placed under the transmitter, 13 to 40
centimeters away from it.
Simply move the transmitter or the probes until all the active probes are 13 to 40 centimeters away from
the transmitter.
4.2.1.13 Please keep the probes below the transmitter
Guiding Star is able to track the probes' position only when they are placed under the transmitter, 13 to 40
centimeters away from it.
Simply move the transmitter or the probes until all the active probes are below the transmitter.
4.2.1.14 Remove the inner probe from the nail
When Guiding Star switches from the mode Find to the mode Display then it stores the inner probe's
position and displays this message to warn the surgeon to unlock the inner probe from the nail's hole.
Simply unlock the inner probe from the nail's hole by rotating it slightly and withdraw it by approximately
2 centimeters.
The system will continue to display the stored position, not the actual position of the inner probe.
4.2.1.15 The two probes are too far from each other. If you have removed the outer probe
because you want to start drilling, please press LOCK HOLE rst
When Guiding Star is in the mode Switch and the external probe is too far from the inner probe then the
system thinks that the surgeon may start drilling throught the detected hole before removing the inner probe
rst; this action would damage the inner probe if it is still locked in the distal hole.
If the external probe has been removed temporarily, then ignore the message but keep in mind that you
shouldn't start drilling while the inner probe is still locked into the distal hole.
If the external probe has been removed in order to start drilling, press the Lock hole button on the
bottom-right hand corner of the screen before proceeding; the system will store the inner probe's position and
switch to the Display mode; then it will prompt you to remove the inner probe from the distal hole to allow
the drill to pass through.
4.2.1.16 The system is warming up. Please wait
This message appears for about 5 minutes while the system is warming up. This happens because the
navigational takes 5 minutes of continuous operation to reach its highest accuracy.
The message does not block the normal operation of Guiding Star, but be aware that the system will
perform with a lower accuracy if calibrated or used while this message is displayed on the screen.
The message disappears automatically 5 minutes after the switch on procedure.
4.2.1.17 One or more sensors are not connected properly
This message appears when one or more probes have not been connected properly.
If the system is in the Find or Display mode then a previously connected probe has been disconnected.
Reconnect the probe
If the system is in the Calibration or Failure mode then you can identify which probe is not connected
properly by checking the lower part of the computer unit screen:
a diagram depicting the connected sensors is displayed: it will indicate whether the 2 probes are connected
properly. If only one probe is connected then check the cables and connectors.
Note that if a probe is being connected to an amplier that was not previously connected or was connected
to a faulty probe, then switch o the navigational and wait at least 1 minute before switching it on again.
4.2.1.18 The sensor n. X is saturated
One probe is too close to the transmitter or to a source of electromagnetic noise. Move the sensor away from
the transmitter or deal with the electromagnetic noise to remove the message from the screen.
4.2.1.19 The sensor n. X is transmitting bad data
Probe connected to socket X is damaged. Replace it with another probe.

4.2.1.20 The transmitter is not running. Is it connected properly to the navigation unit?
The transmitter is not properly connected to the navigational unit.

Switch o the system, connect the transmitter to the navigational unit and switch the system on again.
4.2.1.21 There are some problems with the navigation system. Is it connected properly and
switched on?
The navigational unit is switched o or is not properly connected.

Connect the navigational unit to the computer unit and switch it on.
4.2.1.22 The startup script is missing. Please contact the assistance
4.2.1.23 The system was switched on a long time ago and for security reasons it needs to
be restarted. Soon the system will be automatically switched o
The system will switch o automatically in few minutes. This message appears after the Guiding Star has
been left switched on for several days in a row.
4.2.1.24 An external source of noise is disturbing the system. The measures on the screen
could be wrong.
The message appears when a source of electrical or magnetic noise is interfering with the system, or when the
probes are moved too quickly or are shaking.
If the probes are being moved too quickly or are shaking, just keep them still for few seconds and the
message will disappear.
If a source of electrical or magnetic noise is interfering with the system, then relocate the Guiding Star's
transmitter or the source of noise.
Turning o suspect electrical equipment is often the best method of determining sources of noise.
Once a source of noise is discovered, remove the device from the area or turn its power o during
tracking. Critical equipment may be shielded as long as the shielding does not result in metal distortion
(see Distortion section below). Increasing the distance between the noise source and the sensor, or
decreasing the sensor distance from the transmitter will reduce the noise.
4.2.1.25 The probe connected on the port number X has reached the maximum number of
usages and cannot be used. Replace it with a new one.
The probe connected to the specied navigational unit's socket has reached its maximum usages number and
cannot be used anymore. Replace the probe with a new one and then press the button Check again visible
on the bottom-right corner of the computer unit's screen.
4.2.1.26 The probe connected to the connector X can be used one more time after this
procedure. Remember to order a new one.
The probe connected to the specied navigational unit's socket is approaching its maximum usage limit. A
new probe is needed for the next surgical procedure. The message will disappear automatically after a few
seconds.
4.2.1.27 This is the last time that the probe connected to the connector 2 can be used.
Remember to replace it for the next procedure.
The probe connected to the specied navigational unit's socket has reached its maximum usage limit. A new
probe must be provided for the next surgical procedure. The message will disappear automatically after few
seconds.
4.2.2 Extreme and erratic variation of the probes' position is displayed on the
screen
4.2.2.1 The external probe's position appears steeply inclined towards one direction and, when
moved a little, it appears steeply inclined to the opposite direction
This happens when the external probe is oriented approximately 90 degrees to the distal hole. When moved a
few millimeters the external probes starts seeing the other end of the distal hole, so the inclination displayed
on the screen changes to indicate that the external probe is now pointing to the distal hole from behind.
Rotate the probe 90 degrees.
4.2.2.2 After the calibration the external probe's position is not perfectly aligned and centered
This happens when the inner probe is not securely locked into the calibration stand. Repeat the calibration
procedure taking care to lock the probe securely
Chapter 5
Technical data
5.1 Storage and Operating Specications
Storage conditions: 0°C to 60°C with 20% to 90% humidity, non-condensing
Operating conditions: 15°C to 35°C.
5.2 Computer unit

Power supply: 100-240V 47-63Hz. 80W
Display: 17 color active matrix LCD, 5 wire resistive touch screen
Resolution: 1280 x 1024 pixels
Processor: Intel® Mobile Pentium M (1.6GHz) with 1 MB (2nd level) cache memory
Hard disk drive: 20GB
System memory: 512MB DDR RAM
Audio: Internal speaker, amplied mono, 8 ohm, Speaker Out (1/8" mini-phone), Line-in and Microphone-
in (1/8 miniphone)
Ports: 2 USB, Type A receptacles, USB 2.0 compliant 1 DVI-I digital/analog video output 1 Serial,
RS-232, 9-pin micro-miniature-D LAN 10/100 BaseT Ethernet, RJ-45 1 Compact Flash memory socket,
Type I 1 PCMCIA/CardBus Slot, Type I or Type II
Warranty: one year limited warranty
5.3 Power supply unit

Power: 100-240V, 50/60Hz 100Wmax
Fuses: F1-F4, T4.0AL 250V
Operating temperature: 15°C to 35°C
5.4 Navigational unit

5.4.1 Navigational unit
Power supply: from 85 to 265V, 47-63Hz. 60 VA
Operating temperature: 15°C to 35°C
Warm up: System meets accuracy specications after 5 mins.
61
CHAPTER 5. TECHNICAL DATA 62
5.4.2 Transmitter
3.75 (9.6cm) cube with 10' (3.05m) cable
5.4.3 Sensors
Sensor max OD 1.3mm
Sensor max length 6.7mm
Cable max OD 0.6mm
Cable length: 2.5 meters
USP class 6 epoxy sensor housing
USP 6 polyester protective wrap (bare sensor only)
Maximum temperature of exposure 150 degrees C
Sensor assembly and cable materials are plasma, EtO, gamma and cold sterilant tolerant.
Semiconductor devices in the connector are not gamma shielded and may be damaged or erased if
exposed to gamma radiation.
Connectors are not sealed and must not be subjected to immersion in liquids of any type
Do not subject cable to an axial pull greater than 200 grams.
Additional materials for vinyl sensor assemblies: Tygon tubing USP 6, USP class 6 epoxy tip PVC shrink
tubing on cable at connector end
Connector housing is PEEK material
Static accuracy: 1.4mm RMS position, 0.5 degree RMS orientation
Translation range: 20 cm minimum to 71 cm maximum in X, +/- 30 cm in Y and Z in the forward

(positive X) hemisphere only.
Update rate: 7.1 to 90 measurements per second. Default measurement rate = 68.3 Hz, The system is
calibrated at 68.3 Hz.
5.4.4 Preampliers
Module max OD (minus threaded cap): 23.5mm
Module max length (including sensor connector) 163mm
Module length (excluding sensor connector) 144mm
Cable max OD 5mm
Cable length 3 meters
NOTE: Current pre-ampliers are designed with consumer grade materials and construction. Specically,
they are designed to be resistant only to plasma sterilization method. Immersion in liquids will render them
inoperable.
5.5 Software
Operating system: Windows XP SP2
Application: LIDIS/TOCOS software version 1.120 or newer
Security: LIDIS/TOCOS runs in a limited account. All the TCP-IP ports are closed, except for the
LIDIS / TOCOS port(48740), open to connections from the local network.

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Guiding Star's User Manual

2.4.3 The "Failure mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

3.6.4 Disconnect the probes and the preampliers . . . . . . . . . . . . . . . . . . . . . . . 54

4 Support and troubleshooting 55

4.2.1.1 The application is displaying old data . . . . . . . . . . . . . . . . . 56

4.2.1.3 The probes are not placed on the calibration stand . . . . . . . . . 56

4.2.1.5 Keep the calibration stand still . . . . . . . . . . . . . . . . . . . . 57

4.2.1.6 Cannot check the rewall's status. Contact assistance . . . . . . . . 57

4.2.1.7 The LIDIS/TOCOS TCP port is not restricted. Contact assistance . 57

4.2.1.8 The LIDIS/TOCOS UDP port is open. Contact assistance . . . . . 57

4.2.1.9 One or more TCP ports are open. Contact assistance . . . . . . . . 57

4.2.1.10 One or more UDP ports are open. Contact assistance . . . . . . . . 57

4.2.1.13 Please keep the probes below the transmitter . . . . . . . . . . . . 57

4.2.1.14 Remove the inner probe from the nail . . . . . . . . . . . . . . . . 58

4.2.1.16 The system is warming up. Please wait . . . . . . . . . . . . . . . . 58

4.2.1.17 One or more sensors are not connected properly . . . . . . . . . . . 58

4.2.1.18 The sensor n. X is saturated . . . . . . . . . . . . . . . . . . . . . 58

4.2.1.19 The sensor n. X is transmitting bad data . . . . . . . . . . . . . . . 58

4.2.1.20 The transmitter is not running. Is it connected properly to the navi-

4.2.1.22 The startup script is missing. Please contact the assistance . . . . . 59

Warnings and Precautions

 Keep your hands dry when assembling the device.

 Use the device only in an operating theater.

 No user-servicable components inside!

The Guiding Star medical device comprises:

 A cart with wheels (4)

 A extension arm with transmitter (mounted on the cart) (5,6)

 A navigational unit (mounted on the cart) (2)

 A power supply unit (mounted on the cart) (3)

Figure 1.1: GUIDING STAR Parts description

1. Computer unit with integrated display and touch screen

3. Power supply unit

4. Cart with wheels

8. Computer button on/o

9. Navigation unit power and USB connection

10. Navigation unit 4 socket

11. Transmitter cable connected to the navigation unit

12. Power unit no/o button

13. Wheel with brake

14. Computer unit power and USB connection

The cart is mounted on four wheels (2 with brakes) and provides:

 a hanging plate holding the navigational unit (see on page 17).

 supports for the cables.

Figure 1.2: Cart

Figure 1.3: Front wheel with brake

1.1.1.2 Computer unit

Figure 1.5: Computer unit

1.1.1.3 Extension arm with transmitter

Figure 1.6: The extension arm with the transmitter

The extension arm with the transmitter

1.1.1.4 Navigational unit

The navigational unit is connected to:

1. the computer unit (see on the previous page) by a USB cable

Figure 1.7: Navigational unit

Figure 1.8: The preamplier

WARNING: The preampliers must be sterilized as described on page 32.

1.1.1.6 Power unit

from the electrical power. Each unit has to be switched on separately.

Figure 1.9: Power unit

1.1.2 LIDIS module

The LIDIS module device comprises:

 A inner probe (disposable) (15)

 A external probe (disposable) (22)

2.4.3 The "Failure mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

3.6.4 Disconnect the probes and the preampliers . . . . . . . . . . . . . . . . . . . . . . . 54

4.2.1.1 The application is displaying old data . . . . . . . . . . . . . . . . . 56

4.2.1.3 The probes are not placed on the calibration stand . . . . . . . . . 56

4.2.1.5 Keep the calibration stand still . . . . . . . . . . . . . . . . . . . . 57

4.2.1.6 Cannot check the rewall's status. Contact assistance . . . . . . . . 57

4.2.1.7 The LIDIS/TOCOS TCP port is not restricted. Contact assistance . 57

4.2.1.8 The LIDIS/TOCOS UDP port is open. Contact assistance . . . . . 57

4.2.1.9 One or more TCP ports are open. Contact assistance . . . . . . . . 57

4.2.1.10 One or more UDP ports are open. Contact assistance . . . . . . . . 57

4.2.1.13 Please keep the probes below the transmitter . . . . . . . . . . . . 57

4.2.1.14 Remove the inner probe from the nail . . . . . . . . . . . . . . . . 58

4.2.1.16 The system is warming up. Please wait . . . . . . . . . . . . . . . . 58

4.2.1.17 One or more sensors are not connected properly . . . . . . . . . . . 58

4.2.1.18 The sensor n. X is saturated . . . . . . . . . . . . . . . . . . . . . 58

4.2.1.19 The sensor n. X is transmitting bad data . . . . . . . . . . . . . . . 58

4.2.1.20 The transmitter is not running. Is it connected properly to the navi-

4.2.1.22 The startup script is missing. Please contact the assistance . . . . . 59

Keep your hands dry when assembling the device.

Use the device only in an operating theater.

No user-servicable components inside!

A cart with wheels (4)

A extension arm with transmitter (mounted on the cart) (5,6)

A navigational unit (mounted on the cart) (2)

A power supply unit (mounted on the cart) (3)

8. Computer button on/o

12. Power unit no/o button

a hanging plate holding the navigational unit (see on page 17).

supports for the cables.

Figure 1.8: The preamplier

WARNING: The preampliers must be sterilized as described on page 32.

A inner probe (disposable) (15)

A external probe (disposable) (22)

A calibration accessory (27)

A locating pin (25)

Two drilling spacers (26)

Figure 1.31: Sockets for the preampliers connections

Figure 1.32: The preamplier's connector

Figure 1.33: The preamplier's socket (connect the probe here)

Do not use autoclave sterilization for probes and preampliers!

2 LIDIS inner probes (nr.14) (1 as a spare),

2 LIDIS external probes (1 as a spare),

2 Calibration tools (1 as a spare),

2 Locating pins (1 as a spare),

Protect cables or any other parts from squeezing.

Do not walk on plugs and cables.

Check all connectors for damaged pins.

Check all plugs and sockets for good contacts.

Do not bend probe or preamplier cables.

Protect cables or any other parts from squeezing.

Do not walk on plugs and cables.

Do not drop probes or preampliers on hard surfaces.

Check component connectors for damaged pins.

Check all plugs and sockets for good contacts.

Figure 2.2: System check mode

2.4.2 The Welcome mode

Figure 2.3: "Welcome mode

2.4.3 The "Failure mode