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, reproduced 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

II 1

Warnings and Precautions

Introduction

10

Hardware description

12

1.1

12

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.1.1

1.1.2

1.2

1.3

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

1.1.1.6

Power unit

LIDIS module

1.4

1.6

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19

Inner probe

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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

21

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

24

Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

25

1.2.1

Assemblying the computer holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

25

1.2.2

Assemblying the arm with the transmitter

28

Connections

. . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1.3.1

Connections that have to be made before entering the operating theater

1.3.2

Connections that have to be made before switching on the device

Sterilization

30

. . . . . . .

30

. . . . . . . . . . .

31

If only the LIDIS module is to be used . . . . . . . . . . . . . . . . . . . . .

31

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

32

Instructions for sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

32

1.4.1.1

GUIDING STAR

32

1.4.1.2

LIDIS module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

32

Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

33

1.4.1

1.5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1.1.2.1

1.3.2.1

2

6

Cleaning and maintenance

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

33

1.6.1

GUIDING STAR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

33

1.6.2

LIDIS module

34

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Software description

35

2.1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

35

2.2

Starting the software

35

2.3

GUIDING STAR user interface

2.4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

GUIDING STAR modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

37

2.4.1

The System check mode

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

37

2.4.2

The Welcome mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

37

2

3

CONTENTS

2.4.3 2.5

2.6

The "Failure mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

37

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

2.5.8

Position of the nail distal holes

2.5.9

Position of the LIDIS external probe

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

41 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

The Find hole mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

43

2.6.4

2.6.3.1

Locking the hole

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

44

2.6.3.2

Terminating the procedure . . . . . . . . . . . . . . . . . . . . . . . . . . .

44

The Display hole mode

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

44

2.6.4.1

When the drill is successful . . . . . . . . . . . . . . . . . . . . . . . . . . .

44

2.6.4.2

When the drill fails . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

44

Procedures 3.1

3.2

3.3

3.4

3.5

3.6

40 40

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The LIDIS modes

2.6.3

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

45

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

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

3.2.9

Positioning the transmitter

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

46

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

46

3.2.10 The warm-up time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

46

LIDIS module preparations (before entering the operating theater) . . . . . . . . . . . . . . .

47

3.3.1

Prerequisites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

47

3.3.2

Sterilization

47

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

47

3.4.1

LIDIS module preparations (before the surgical procedure)

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

47

3.4.2

Connection of LIDIS module

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

47

3.4.3

Switching on the navigational unit . . . . . . . . . . . . . . . . . . . . . . . . . . . .

47

3.4.4

Switching on the computer unit

. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

48

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

3.5.7

Switching on the navigational unit . . . . . . . . . . . . . . . . . . . . . . . . . . . .

53

LIDIS Clinical procedures

. . . . . . . . . . . . . . . . . . . . . . . . . . .

Post operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

53

3.6.1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

53

3.6.2

Switching o the units

3.6.3

Disconnecting the main power supply

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

53 54

4

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

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

56

4.2.1.2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The application is displaying old data . . . . . . . . . . . . . . . . .

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.2.1.3

4.2.1.4

The probes are not placed on the calibration stand

. . . . . . . . .

56

56

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

. . . . . . . . . . . . . . . . . . . . .

5

CONTENTS

4.2.1.19

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

4.2.1.20

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

4.2.1.21

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

There are some problems with the navigation system. Is it connected 59

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

An external source of noise is disturbing the system. The measures

4.2.1.24

on the screen could be wrong.

4.2.1.25

. . . . . . . . . . . . . . . . . . . . . . . .

59

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.

4.2.1.26

. . . . .

59

The probe connected to the connector X can be used one more time after this procedure. Remember to order a new one. . . . . . . . . . . . . .

4.2.1.27

59

This is the last time that the probe connected to the connector 2 can be used. Remember to replace it for the next procedure.

. . . . . . . . . .

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

4.2.2.2

After the calibration the external probe's position is not perfectly aligned and

and, when moved a little, it appears steeply inclined to the opposite direction centered . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

59

properly and switched on? . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.2.1.22

4.2.2

58

Technical data

60 60 60 60

61

5.1

Storage and Operating Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

61

5.2

Computer unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

61

5.3

Power supply unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

61

5.4

Navigational unit

61

5.5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.4.1

Navigational unit

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.4.2

Transmitter

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

61 62

5.4.3

Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

62

5.4.4

Preampliers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

62

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

ˆ

Do not open the device's units without written permission from Ekliptik d.o.o..

ˆ

Keep your hands dry when assembling the device.

ˆ

Use the device only in an operating theater.

ˆ

Do not open any unit of the system without prior authorization. For trained personnel only!

ˆ

Risk of high voltage hazard! Fatal injury can occur, especially if the power switch is on and power cord is plugged in.

ˆ

Do not use wet hands when working with power supply unit, such as plugging in the power cord etc.

ˆ

Do not insert any metallic objects (screwdriver, wire, etc.) into any opened slots.

ˆ

No user-servicable components inside!

ˆ

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.

ˆ

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.

ˆ

When power is applied or the system is running, do not touch exposed electronic components. Contact with exposed components could cause injury.

ˆ

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.

ˆ

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.

ˆ

Remove the probes, preamplier and transmitter gently from their mounting bracket or holder. Do not yank or pull on the cable.

ˆ

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.

ˆ

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.

ˆ

Electrical and magnetic devices close to the Guiding Star tracking area may disturb the detected probes' position and inuence the surgical procedure.

ˆ

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

ˆ

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

ˆ

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:

ˆ

A cart with wheels (4)

ˆ

A computer unit with integrated display and touch screen (mounted on the cart) (1)

ˆ

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

ˆ

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

ˆ

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

12

CHAPTER 1.

HARDWARE DESCRIPTION

Figure 1.1: GUIDING STAR Parts description

1. Computer unit with integrated display and touch screen 2. Navigational unit

13

CHAPTER 1.

HARDWARE DESCRIPTION

14

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:

ˆ

a VESA adapter for connecting the computer unit (see on page 16).

ˆ

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.

ˆ

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

ˆ

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.

CHAPTER 1.

15

HARDWARE DESCRIPTION

Figure 1.2: Cart

Figure 1.3: Front wheel with brake

CHAPTER 1.

HARDWARE DESCRIPTION

16

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.

CHAPTER 1.

HARDWARE DESCRIPTION

17

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.

CHAPTER 1.

1.1.1.5

HARDWARE DESCRIPTION

18

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.

CHAPTER 1.

HARDWARE DESCRIPTION

Figure 1.9: Power unit

1.1.2

LIDIS module

The LIDIS module device comprises:

ˆ

A inner probe (disposable) (15)

ˆ

A external probe (disposable) (22)

ˆ

Two preampliers (to be connected to the navigational unit and the LIDIS probes) (29)

ˆ

A calibration accessory (27)

ˆ

A locating pin (25)

ˆ

Two drilling spacers (26)

19

CHAPTER 1.

HARDWARE DESCRIPTION

Figure 1.10: LIDIS module Parts description

Parts of LIDIS module: 15. Inner probe

20

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HARDWARE DESCRIPTION

21

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

CHAPTER 1.

22

HARDWARE DESCRIPTION

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.

CHAPTER 1.

HARDWARE DESCRIPTION

23

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 preampliers 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.

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HARDWARE DESCRIPTION

24

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.

CHAPTER 1.

HARDWARE DESCRIPTION

25

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

CHAPTER 1.

HARDWARE DESCRIPTION

26

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

CHAPTER 1.

HARDWARE DESCRIPTION

27

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.

CHAPTER 1.

1.2.2

HARDWARE DESCRIPTION

Assemblying the arm with the transmitter

Figure 1.28: Parts of moving arm

28

CHAPTER 1.

HARDWARE DESCRIPTION

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)

29

CHAPTER 1.

HARDWARE DESCRIPTION

30

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.

ˆ

The power cord with the 3-hole plug has to be connected to the socket on the back of the navigational unit.

ˆ

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:

ˆ

connect one end of the USB cable to one of the two USB sockets on the bottom of the computer unit.

ˆ

connect the other end of the cable to the USB socket on the back of the navigational unit.

CHAPTER 1.

1.3.2

HARDWARE DESCRIPTION

31

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)

CHAPTER 1.

HARDWARE DESCRIPTION

32

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:

ˆ

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

ˆ

2 LIDIS external probes (1 as a spare),

ˆ

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:

ˆ

2 Calibration tools (1 as a spare),

ˆ

2 Locating pins (1 as a spare),

ˆ

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.

CHAPTER 1.

HARDWARE DESCRIPTION

33

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.

ˆ

Check cables of the Guiding Star system regularly for any strains or cuts in the insulation.

ˆ

Protect cables or any other parts from squeezing.

ˆ

Do not walk on plugs and cables.

ˆ

Check all connectors for damaged pins.

CHAPTER 1.

ˆ

HARDWARE DESCRIPTION

34

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 !

ˆ

Do not bend probe or preamplier cables.

ˆ

Protect cables or any other parts from squeezing.

ˆ

Do not walk on plugs and cables.

ˆ

Do not drop probes or preampliers on hard surfaces.

ˆ

Check component connectors for damaged pins.

ˆ

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.

2.3.2

SOFTWARE DESCRIPTION

36

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.

CHAPTER 2.

SOFTWARE DESCRIPTION

37

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:

ˆ

GUIDING STAR/LIDIS

ˆ

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.

CHAPTER 2.

SOFTWARE DESCRIPTION

38

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.

CHAPTER 2.

SOFTWARE DESCRIPTION

39

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).

CHAPTER 2.

2.5.4

40

SOFTWARE DESCRIPTION

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:

ˆ

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),

ˆ

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.

CHAPTER 2.

SOFTWARE DESCRIPTION

41

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

CHAPTER 2.

42

SOFTWARE DESCRIPTION

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.

r 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.

CHAPTER 2.

SOFTWARE DESCRIPTION

43

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

CHAPTER 2.

2.6.3.1

SOFTWARE DESCRIPTION

44

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 theater) 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 procedure 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.

3.2.3

46

PROCEDURES

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.

CHAPTER 3.

PROCEDURES

47

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:

ˆ

Only the distal holes of CANNULATED intramedullary nails can be located.

ˆ

The cannulated intramedullary nail with its jig adapter for proximal holes has to be compatible with the Guiding Star's inner probe.

ˆ

The drilling spacers have to be compatible with the drill tools.

ˆ

The locating pin has to be compatible with the screws used to x the nail.

ˆ

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:

ˆ

The navigational unit and the computer unit must be switched o.

ˆ

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.

3.4.3

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 previous page) and BEFORE switching on the computer unit (see on the following page). Switch on the navigational unit with the button located on the back of the navigational unit.

CHAPTER 3.

3.4.4

48

PROCEDURES

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:

ˆ

The navigational unit and the computer unit must be switched on.

ˆ

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

CHAPTER 3.

49

PROCEDURES

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:

ˆ

the probes are not placed correctly in the calibration stand: check the position of the probes and repeat the operation; or

ˆ

the calibration accessory was shaking during the calibration: repeat the operation keeping the calibration accessory still; or

ˆ

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

ˆ

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). 7. Rotate the inner probe until it locks in the distal hole of the nail. 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.

CHAPTER 3.

3.5.5

50

PROCEDURES

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

CHAPTER 3.

PROCEDURES

51

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

CHAPTER 3.

PROCEDURES

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

52

CHAPTER 3.

PROCEDURES

53

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. 2. Rotate the inner probe until it locks in the distal hole of the nail. 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.

3.5.7

Switching on the navigational unit

WARNING: The navigational unit must be switched on AFTER the preampliers and the probes have been connected (see on page 46) 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.

3.6 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.

CHAPTER 3.

3.6.3

PROCEDURES

54

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:

ˆ

Website: http://ekliptik.si Click on Support to le a support request

ˆ

Mail: Ekliptik d.o.o. Teslova, 30 1000 Ljubljana Slovenia

ˆ

Telephone: +386 (0) 1 477 66 31

ˆ

Fax +386 (0) 1 477 66 32

ˆ

Email: [email protected]

When submitting a request for support you should report the following data:

ˆ

The serial number of your Guiding Star system

ˆ

The serial numbers of the probes

ˆ

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.

56

SUPPORT AND TROUBLESHOOTING

4.2 Troubleshooting 4.2.1

4.2.1.1

Responding to warnings or error messages that appear on the screen

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.

ˆ

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.

ˆ

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.

ˆ

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.

ˆ

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.

ˆ

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.

CHAPTER 4.

SUPPORT AND TROUBLESHOOTING

4.2.1.5

57

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

The system is not congured correctly. Contact Assistance.

4.2.1.8

The LIDIS/TOCOS UDP port is open. Contact assistance

The system is not congured correctly. Contact Assistance.

4.2.1.9

One or more TCP ports are open. Contact assistance

The system is not congured correctly. Contact Assistance.

4.2.1.10

One or more UDP ports are open. Contact assistance

The system is not congured correctly. Contact Assistance.

4.2.1.11

One or more TCP and or UDP ports are open. Contact assistance

The system is not congured correctly. 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.

CHAPTER 4.

4.2.1.14

58

SUPPORT AND TROUBLESHOOTING

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.

ˆ

If the system is in the Find or Display mode then a previously connected probe has been disconnected. Reconnect the probe

ˆ

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.

CHAPTER 4.

4.2.1.20

SUPPORT AND TROUBLESHOOTING

59

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

The system is not congured correctly. Contact 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.

ˆ

If the probes are being moved too quickly or are shaking, just keep them still for few seconds and the message will disappear.

ˆ

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

CHAPTER 4.

SUPPORT AND TROUBLESHOOTING

60

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 ˆ

Storage conditions: 0°C to 60°C with 20% to 90% humidity, non-condensing

ˆ

Operating conditions: 15°C to 35°C.

5.2 Computer unit ˆ

Power supply: 100-240V 47-63Hz. 80W

ˆ

Display: 17 color active matrix LCD, 5 wire resistive touch screen

ˆ

Resolution: 1280 x 1024 pixels

ˆ

Processor: Intel® Mobile Pentium M— (1.6GHz) with 1 MB (2nd level) cache memory

ˆ

Hard disk drive: 20GB

ˆ

System memory: 512MB DDR RAM

ˆ

Audio: Internal speaker, amplied mono, 8 ohm, Speaker Out (1/8" mini-phone), Line-in and Microphonein (1/8 miniphone)

ˆ

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

ˆ

Warranty: one year limited warranty

5.3 Power supply unit ˆ

Power: 100-240V, 50/60Hz 100Wmax

ˆ

Fuses: F1-F4, T4.0AL 250V

ˆ

Operating temperature: 15°C to 35°C

5.4 Navigational unit 5.4.1

Navigational unit

ˆ

Power supply: from 85 to 265V, 47-63Hz. 60 VA

ˆ

Operating temperature: 15°C to 35°C

ˆ

Warm up: System meets accuracy specications after 5 mins.

61

CHAPTER 5.

5.4.2

ˆ

62

TECHNICAL DATA

Transmitter

3.75 (9.6cm) cube with 10' (3.05m) cable

5.4.3

Sensors

ˆ

Sensor max OD 1.3mm

ˆ

Sensor max length 6.7mm

ˆ

Cable max OD 0.6mm

ˆ

Cable length: 2.5 meters

ˆ

USP class 6 epoxy sensor housing

ˆ

USP 6 polyester protective wrap (bare sensor only)

ˆ

Maximum temperature of exposure 150 degrees C

ˆ

Sensor assembly and cable materials are plasma, EtO, gamma and cold sterilant tolerant.

ˆ

Semiconductor devices in the connector are not gamma shielded and may be damaged or erased if exposed to gamma radiation.

ˆ

Connectors are not sealed and must not be subjected to immersion in liquids of any type

ˆ

Do not subject cable to an axial pull greater than 200 grams.

ˆ

Additional materials for vinyl sensor assemblies: Tygon tubing USP 6, USP class 6 epoxy tip PVC shrink tubing on cable at connector end

ˆ

Connector housing is PEEK material

ˆ

Static accuracy: 1.4mm RMS position, 0.5 degree RMS orientation

ˆ

Translation range: 20 cm minimum to 71 cm maximum in X, +/- 30 cm in Y and Z in the forward (positive X) hemisphere only.

ˆ

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

ˆ

Module max OD (minus threaded cap): 23.5mm

ˆ

Module max length (including sensor connector) 163mm

ˆ

Module length (excluding sensor connector) 144mm

ˆ

Cable max OD 5mm

ˆ

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 ˆ

Operating system: Windows XP SP2

ˆ

Application: LIDIS/TOCOS software version 1.120 or newer

ˆ

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.