GE InstaTrak 3500 Plus Advanced ENT Application Op Ma_SM_1008214-NAV_3 InstaTrak 3500 Plus Advanced ENT Application Operator’s Manual

InstaTrak® 3500 Plus

Advanced ENT Application

Operator’s Manual

1008214-NAV R3

Revision History

Rev Date Comments

R00 June 2005 Manufacturing Release
R3 June 2008 Headset placement changes

®

InstaTrak

is a registered trademark of GE Healthcare

GE Healthcare

384 Wright Brothers Drive

Salt Lake City, UT 84116

Phone [phone]

Fax [phone]

GE OEC Medical Systems, Inc. – A General Electric Company – Going to market as GE Healthcare

1008214-NAV R3

Printed in USA

Copyright 2008 GE Healthcare

Page ii

CONTENTS

CONTENTS

INTRODUCTION............................................................1-1

1

Intended Use, Indications & Contraindications, Warnings & Precautions....................1-2

Intended Use.......................................................................................................... 1-2

Indications for Use.................................................................................................. 1-2

Contraindications.................................................................................................... 1-2

Warnings and Precautions..................................................................................... 1-2

The InstaTrak 3500® Plus............................................................................................ 1-4

HIPAA Privacy Rule Compliance.................................................................................. 1-5

2 PRE-OPERATIVE..........................................................2-1

Scanner Compatibility................................................................................................... 2-2

Data Transfer................................................................................................................ 2-2

Radiology...................................................................................................................... 2-2

Transferring Scans To the InstaTrak 3500 Plus........................................................... 2-3

Scanning Protocols................................................................................................. 2-3

Registration................................................................................................................... 2-4

Methods ........................................................................................................... 2-4

Automatic Registration Headset ................................................................................... 2-6

Headset Selection Guidelines................................................................................ 2-6

Verification Pad Placement.................................................................................... 2-8

Headset Placement................................................................................................ 2-9

Fiducial Marker Placement Guidelines.......................................................... 2-10

CT Scanning Protocol .......................................................................................... 2-10

MRI Scanning Protocol......................................................................................... 2-11

Patient Preparation............................................................................................... 2-12

Scanning............................................................................................................... 2-12

3 GETTING STARTED ......................................................3-1

HIPAA “Privacy Rule” Compliance ............................................................................... 3-2

Transferring Data.......................................................................................................... 3-3

Scanner Transfer.................................................................................................... 3-3

Network Transfer.................................................................................................... 3-3

Transferring Between Systems.............................................................................. 3-4

Transferring Using a CD......................................................................................... 3-6

Transferring Scans: CD to Hard Drive............................................................. 3-7

Hard Drive to CD.............................................................................................. 3-7

Auto Registration Verification................................................................................. 3-9

4 OPERATING ROOM ......................................................4-1

Operating Room Setup................................................................................................. 4-2

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CONTENTS

HIPAA “Privacy Rule” Compliance.........................................................................4-2

Logon and Logout................................................................................................... 4-2

Password Protection............................................................................................... 4-2

Powering and Logging On To The System ............................................................4-2

Changing The Password........................................................................................ 4-4

Disabling the Logon Requirement..........................................................................4-5

Copying Sensitive Patient Data..............................................................................4-7

Copying snapshots to a Floppy Disk or CD.....................................................4-7

ElectroMagnetic Tracking Guidelines..................................................................... 4-9

Standard ENT Equipment and Instruments..........................................................4-10

Transsphenoidal Procedures.........................................................................4-11

Skull-base Procedures................................................................................... 4-11

General and Optional Equipment and Instruments........................................4-11

Setting Up The InstaTrak 3500 Plus.....................................................................4-13

Loading Images....................................................................................................4-14

Visualization Display............................................................................................. 4-16

Snapshot...............................................................................................................4-18

Contrast/Brightness Adjustment........................................................................... 4-18

Crosshair Adjustment ........................................................................................... 4-19

Zoom Control Adjustment.....................................................................................4-20

Display Layouts ....................................................................................................4-21

Orthogonal Views...........................................................................................4-21

3D Surface Model ..........................................................................................4-22

Expand Button................................................................................................ 4-23

Tracking and Surgical Review Views ...................................................................4-24

Surgical Review Views .........................................................................................4-25

Tracking View Views.............................................................................................4-26

Using the Automatic Registration Headset.................................................................4-29

Attaching Transmitter to the Headset................................................................... 4-29

Attaching the Verification Pad ..............................................................................4-29

Placing the Automatic Headset ............................................................................4-30

Draping................................................................................................................. 4-31

Using Transmitter Arm Attachment ......................................................................4-32

Attaching the Transmitter Arm to the Mayfield® Cranial Stabilization System4-32

Attaching the Transmitter to the Transmitter Arm ................................................4-34

Attaching the Universal Transmitter Arm.............................................................. 4-35

Draping................................................................................................................. 4-35

Attaching an Instrument..............................................................................................4-37

Attaching a Pointer ............................................................................................... 4-37

Using the Button Probe, P/N 1003632................................................................. 4-38

Nasal Speculum....................................................................................................4-39

Debrider Attachments .................................................................................................4-40

Gyrus™ Diego™ Powered Dissector...................................................................4-41

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CONTENTS

Components................................................................................................... 4-41

Assembly........................................................................................................ 4-42

Disassembly................................................................................................... 4-43

Gyrus Turbo 7000 Debrider.................................................................................. 4-44

Gyrus (Smith and Nephew) ESSential® Shaver Handpiece................................ 4-45

XOMED® STRAIGHTSHOT® and MAGNUM™ Debriders.................................... 4-46

Stryker® Hummer 2 and Hummer TPS debriders: ............................................... 4-47

Linvatec E9000™ High Speed Shaver Handpiece .............................................. 4-48

Calibration................................................................................................................... 4-49

Calibrating Instruments ........................................................................................ 4-49

Calibrating on Transmitter Dimple........................................................................ 4-50

Stryker Hummer and TPS Debriders.................................................................... 4-52

Registration................................................................................................................. 4-53

Automatic Registration Headset........................................................................... 4-53

Auto Plus Registration ................................................................................... 4-53

Collecting Lateral Markers............................................................................. 4-54

Performing a Fiducial or AccuMatch™ Registration ............................................4-55

Fiducial Registration............................................................................................. 4-56

Fiducial Registration Instructions ......................................................................... 4-57

AccuMatch™ Surface Registration ......................................................................4-60

Guidelines for AccuMatch Registration.......................................................... 4-61

Step #1 - Find ................................................................................................ 4-62

Step #2 - Touch ............................................................................................. 4-64

Step #3 - Paint............................................................................................... 4-65

Deleting Points............................................................................................... 4-69

Tracking ...................................................................................................................... 4-73

Freeze Function.................................................................................................... 4-73

Taking a Snapshot......................................................................................... 4-74

Options Menu.............................................................................................................. 4-75

User Defined Text................................................................................................. 4-75

Define TargetTrak................................................................................................. 4-76

Adjust Volume ...................................................................................................... 4-77

Define 3D Surface................................................................................................ 4-78

Verification............................................................................................................ 4-79

Verification Modes................................................................................................ 4-79

Anatomic........................................................................................................ 4-79

Drift................................................................................................................. 4-80

Accuracy ........................................................................................................ 4-80

Verification Setup .................................................................................................4-80

Anatomic Verification..................................................................................... 4-82

Accuracy Verification ..................................................................................... 4-82

To Verify during surgery:......................................................................... 4-82

Drift Verification.............................................................................................. 4-83

Page v

CONTENTS

To Verify during surgery:......................................................................... 4-83

To change the selected Verification point: ..............................................4-83

Video Controls......................................................................................................4-84

5 PROCEDURAL CAPABILITIES ........................................5-1

Procedural Capabilities.................................................................................................5-2

Tool Options ...........................................................................................................5-2

Trajectory ......................................................................................................... 5-3

Oblique Centering...................................................................................... 5-4

Show Trajectory Length Label................................................................... 5-4

Image Fusion.......................................................................................................... 5-4

6 POST-OPERATIVE........................................................6-1

Post-Operative Checklist...............................................................................................6-2

The Button Probe....................................................................................................6-2

The Button Probe, P/N 1003632 ............................................................................6-2

Detaching the Transmitter From the Mayfield Transmitter Attachment Arm.......... 6-3

Detaching the Transmitter From the Universal Transmitter Attachment Arm ........6-4

Removing the Headset...........................................................................................6-4

Detaching the Transmitter and Receiver(s) from the System ................................ 6-4

Removing the Instrument from the Receiver ...................................................6-5

Shutting Down the System..................................................................................... 6-5

Logging Out of the System...............................................................................6-6

Shutting Down the System............................................................................... 6-7

7 INDEX..........................................................................7-1

Page vi

CONTENTS

Table of Tables and Figures

Figure 1-1. Incompatible Tracker Message...............................................................................................1-4

Figure 2-1. Scanning/Surgery...................................................................................................................2-4

Table 2-1. Headset Selection Guidelines..................................................................................................2-6

Figure 2-2. Verification Pad Placement.....................................................................................................2-8

Figure 2-3. Headset Placement.................................................................................................................2-9

Figure 2-4. Fiducial Marker Placement ...................................................................................................2-10

Table 2-2. Recommended CT Scanner Protocol.....................................................................................2-11

Table 2-3. Recommended MRI Protocol.................................................................................................2-11

Figure 3-1. Network Transfer Menu ..........................................................................................................3-3

Figure 3-2. Transfer Data Between Systems............................................................................................3-5

Figure 3-3. Transferring Data Using A CD ................................................................................................3-6

Figure 3-4. Sufficient CD Space Message.................................................................................................3-8

Figure 3-5. Confirm CD Copy Message.....................................................................................................3-8

Figure 3-6. CD Complete Message............................................................................................................3-8

Figure 3-7. Auto Registration Column.......................................................................................................3-9

Figure 4-1. Log-on Menu...........................................................................................................................4-3

Figure 4-2. Change Password Task Window............................................................................................4-4

Figure 4-3. System Administration Button.................................................................................................4-5

Figure 4-4. User Options...........................................................................................................................4-6

Figure 4-5. Image Preview Menu..............................................................................................................4-7

Figure 4-6. De-Identify Data Window........................................................................................................4-8

Figure 4-7. Aspirators..............................................................................................................................4-10

Figure 4-8. Button Probe.........................................................................................................................4-11

Figure 4-9. Axcess System.....................................................................................................................4-11

Figure 4-10. Main Menu..........................................................................................................................4-13

Figure 4-11. Patient Database Menu with Application Selections...........................................................4-14

Figure 4-12 Post Processing Required Dialog .........................................................................................4-15

Figure 4-13. Visualization Menu..............................................................................................................4-16

Figure 4-14. Display Adjustment.............................................................................................................4-17

Figure 4-15. Image Picture......................................................................................................................4-18

Figure 4-16. Crosshair Adjustment..........................................................................................................4-19

Figure 4-17. Zoom Control......................................................................................................................4-20

Figure 4-18. Up and Down Arrows..........................................................................................................4-21

Figure 4-19. Surface Model Adjustment..................................................................................................4-22

Figure 4-20. View Selection Pull Down Menu.........................................................................................4-24

Figure 4-21. Surgical Review Pull Down Menu........................................................................................4-25

Figure 4-22. Probes or Instruments Pull Down Menu..............................................................................4-26

Figure 4-23. Tracking View Pull Down List - Probes...............................................................................4-27

Figure 4-24. Tracking View Pull Down List - Instruments........................................................................4-28

Figure 4-25. Attaching Transmitter to the Headset..................................................................................4-29

Figure 4-26. Starburst Connector............................................................................................................4-33

Figure 4-27. Positioning of Transmitter Arm with Transmitter less than 10” from Surgical Site...............4-33

Figure 4-28. Align Transmitter Latch with Slot ........................................................................................4-34

Figure 4-29. Rotate Transmitter Latch to Secure Transmitter................................................................. 4-34

Figure 4-30. Open Latch -- Insert Transmitter -- Close Latch..................................................................4-35

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CONTENTS

Figure 4-31. Transmitter and Attachment Arm Draping ..........................................................................4-36

Figure 4-32. Insertion of button lever.......................................................................................................4-38

Figure 4-33. Gyrus Diego Powered Dissector, Unassembled.................................................................4-41

Figure 4-34. Gyrus Diego Powered Dissector, Assembled.....................................................................4-42

Figure 4-35. Debrider Attachment to the Gyrus TURBO 7000 Debrider.................................................4-44

Figure 4-36. Debrider Attachment Attached to the Gyrus ESSential Shaver Handpiece........................4-45

Figure 4-37. Debrider Attachment to the XOMED STRAIGHTSHOT Debrider.......................................4-46

Figure 4-38. Debrider Attachment to the Stryker Hummer 2 Debrider....................................................4-47

Figure 4-39. Debrider Attachment to Linvatec High Speed Shaver Handpiece ......................................4-48

Figure 4-40. Calibration ..........................................................................................................................4-49

Figure 4-41. 4 Point Calibration Dialog...................................................................................................4-50

Figure 4-42. Calibrating the Gyrus Diego Powered Dissector.................................................................4-51

Figure 4-43. Suggested Calibration Points .............................................................................................4-51

Figure 4-44 Lateral Marker Position.........................................................................................................4-53

Figure 4-45 Lateral Marker Message.......................................................................................................4-54

Figure 4-46. Use the Registration Button to Select Method....................................................................4-55

Figure 4-47. Registration Method Pull Down Menu ................................................................................4-55

Figure 4-48. Fast Fiducial Registration Display ......................................................................................4-57

Figure 4-49. Identifying Fiducial Markers with 4:1 Magnification.............................................................4-58

Figure 4-50. Field Interference Messages ...............................................................................................4-59

Figure 4-51. Registration Unacceptable Message...................................................................................4-60

Figure 4-52. Registration Unacceptable - Retry Message .......................................................................4-60

Figure 4-53 . AccuMatch Registration Menu...........................................................................................4-62

Figure 4-54. AccuMatch Registration - Find............................................................................................4-63

Figure 4-55. AccuMatch Registration - Touch.........................................................................................4-64

Figure 4-56. AccuMatch Registration – Touch Complete........................................................................4-65

Figure 4-57. AccuMatch Registration - Paint ..........................................................................................4-66

Figure 4-58. AccuMatch Registration – Paint Lines................................................................................4-67

Figure 4-59. AccuMatch Registration - Calculation.................................................................................4-68

Figure 4-60. AccuMatch Registration - Complete...................................................................................4-69

Figure 4-61. AccuMatch™ Registration Menu ........................................................................................4-70

Figure 4-62 Erase Paint Points...............................................................................................................4-71

Figure 4-63 Freeze Button......................................................................................................................4-73

Figure 4-64 Freeze Screen Message .....................................................................................................4-74

Figure 4-65. Options Menu.....................................................................................................................4-75

Figure 4-66 Define TargetTrak Message.................................................................................................4-76

Figure 4-67. Adjust Volume Task Window..............................................................................................4-77

Figure 4-68. Define 3D Surface Task Window........................................................................................4-78

Figure 4-69. Verification Setup Button....................................................................................................4-81

Figure 4-70. Verification Setup Task Window.........................................................................................4-81

Figure 4-71. Video Controls Menu..........................................................................................................4-84

Figure 4-72. Full Screen Video Display...................................................................................................4-85

Figure 5-1 Procedural Capabilities Icons..................................................................................................5-2

Figure 5-2. Tool Options Task Window.....................................................................................................5-3

Figure 6-1. Button Probe - P/N 1003632....................................................................................................6-2

Figure 6-2. Removing Transmitter from Attachment Arm...........................................................................6-3

Figure 6-3. Removing the Transmitter from the Universal Attachment Arm...............................................6-4

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CONTENTS

Figure 6-4. Removing Pointer from the Docking Station...........................................................................6-5

Figure 6-5. Removing Docking Station from Receiver ..............................................................................6-5

Figure 6-6. System Shutdown...................................................................................................................6-6

Page ix

1

INTRODUCTION

INTRODUCTION

Intended Use, Indications &
Contraindications, Warnings &
Precautions

Intended Use

• The InstaTrak® 3500 Plus Surgical Navigation System–Advanced ENT

Application is intended as an aid to the surgeon to precisely locate anatomical

structures in the human body, and to precisely locate the tip and trajectory of
surgical instrumentation in reference to those anatomical structures.

Indications for Use

• The InstaTrak® 3500 Plus–Advanced ENT Application is indicated for use in

surgical procedures that require precise location of surgical instrumentation with

reference to rigid anatomical structures visible on medical images.

Contraindications

• The InstaTrak® 3500 Plus Advanced ENT Application should not be used for

any non-ENT or non-skull-base surgical procedures.

• The InstaTrak® 3500 Plus Advanced ENT Application is contraindicated for

skeletally immature patients.

• The InstaTrak® 3500 Plus Advanced ENT Application should not be used with

patients suspected of having Creutzfeld-Jacob disease. Sterilization of cables
cannot be guaranteed.

• For instruments used with the InstaTrak® 3500 Plus Advanced ENT

Application, follow the specific contraindications for that device.

Warnings and Precautions

• The InstaTrak®3500 Plus Advanced ENT Application provides information from

medical imaging that enhances the information provided to the surgeon. The
InstaTrak® 3500 Advanced ENT Application should be used only as an adjunct
for surgical guidance. It is not a replacement for surgical judgment, expertise, or
knowledge of the anatomy. The InstaTrak® 3500 Plus Advanced ENT
Application is for use by qualified surgeons only and should not be used by any
person not qualified to use this device.

Page 1-2

• Clinical tracking accuracy is subject to many factors. Navigation should be used

only by personnel trained in the use of navigation and experienced with the

INTRODUCTION

anatomy on which navigation will be used. It is the responsibility of the user to

verify tracking accuracy during the procedure to ensure the navigation system is

performing adequately. The user should plan the procedure so that it can be

safely completed without the use of navigation.

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

physician.

• The safety and effectiveness of the InstaTrak® 3500 Advanced ENT Application

has not been validated for use on patients who have electronic devices that make

an internal, direct connection to the cardiovascular system, brain or central

nervous system.

• Only persons who have attended the in-service training courses conducted by GE

Healthcare Technologies Clinical Training Specialists, should attempt to operate

this equipment.

• GE Healthcare Technologies also strongly recommends that radiologists and

scanner technologists acquaint themselves with the intra-operative use of the

InstaTrak® 3500 Plus by reading this manual and attending surgery. Radiology

and OR personnel are both critical components of the InstaTrak® 3500 Plus

Advanced ENT Application team.

• This manual covers the use of the InstaTrak® 3500 Plus Advanced ENT

Application and should be used in conjunction with the InstaTrak® 3500 Plus

Operator’s Manual. The InstaTrak® 3500 Plus Operator’s Manual contains

instructions and information for the basic system platform. Information about

any of the features and functions that are common to all of the applications can

be found in the InstaTrak® 3500 Plus Operator’s Manual.

• Do not connect any equipment to the system, which is not specifically described

in this manual. Whenever AC powered equipment is connected to the system, the

user must confirm that applicable Standards for leakage current are met by the

interconnected system any any applied parts.

• Please follow the warnings and cautions embedded in individual sections of this

manual as appropriate. For instruments used with the InstaTrak

®

3500 Plus,

follow the specific warnings and precautions for that device.

Note: The screen images in this manual are for representation purposes only. The actual
images on your display might vary.

Note: No natural latex is used in the manufacture of any of GE Healthcare Technologies
products or packaging used for the InstaTrak

®

3500 Plus system.

Note: This device has been tested for electromagnetic emission and susceptibility in
accordance with IEC 60601-1-2.

Page 1-3

INTRODUCTION

The InstaTrak 3500® Plus

System Components

The components of the InstaTrak® 3500 Plus include

• A high-powered computer,

• A high-resolution touch-screen display,

• A keyboard/mouse, and

• A tracking system.

The patient’s CT or MRI images are acquired and sent to the InstaTrak® 3500 Plus prior
to surgery. The scan is used during the surgical navigation procedure.

The keyboard is used to enter patient identifiers and text. The touch-screen or mouse is
used to interact with the display.

The tracking system is used to track the position of the surgeon’s instruments.

Note The InstaTrak® 3500 Plus uses a specific tracking system. If your System is not

equipped with the correct tracking system, the following message appears after
attempting to enter the Visualization Display for surgical navigation.

Figure 1-1. Incompatible Tracker Message

If this message is seen, the InstaTrak 3500 Plus cannot be used for surgical navigation.
Contact your GE Healthcare Technologies Representative.

Page 1-4

INTRODUCTION

HIPAA Privacy Rule Compliance

The InstaTrak® Plus Surgical Navigation System is compliant with the Privacy Rule, a
Federal regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 protecting the privacy of individually identifiable health information.

Users of the InstaTrak® Plus Surgical Navigation System have the option of assigning a
password before system operation and to de-identify patient data before copying.

Note: To protect sensitive healthcare information, GE Healthcare Technologies strongly

recommends requiring a password to operate the system and de-identifying patient data
before transferring or copying to a CD or floppy disk.

Page 1-5

2

P

RE-OPERATIVE

PRE-OPERATIVE

Scanner Compatibility

The Advanced ENT Application of the InstaTrak® 3500 Plus is designed to interface
with any CT or MRI scanner that can output data in the DICOM 3.0 storage class format.

Data Transfer

Before the InstaTrak® 3500 Plus may be used in surgery, a CT or MRI scan must be
transferred to the system.

If the scanner has the capability to archive DICOM data onto a CD, then the scans can be
downloaded onto a CD directly from the scanner or Radiology workstation and then
loaded onto the InstaTrak® 3500 Plus.

The scans also can be transferred to the system via an Ethernet network. Connectivity
must be established between the scanner or Radiology workstation and the InstaTrak®
3500 Plus or ConneCTstat™ Plus in order to transfer scans in this manner.

There are some basic prerequisites for successful connectivity:
The system uses the DICOM (Digital Imaging and Communications in Medicine) 3.0

standard for network based image transfers. This standard was developed jointly by the
American College of Radiology (ACR) and National Electrical Manufacturers
Association (NEMA) to facilitate data transfer between medical equipment. Many
scanners support this standard by providing a storage or transfer facility to a DICOM­capable device, either directly from the scanner or by means of a workstation. In some
cases, older scanners can be made to output DICOM data through the use of third party
equipment.

Data may be transferred to either the InstaTrak® 3500 Plus or the ConneCTstat™ Plus
through an Ethernet network connection. The Ethernet port is a twisted pair RJ-45
(10/100 Base-T) connector (no ground connection) located on the back panel of the
InstaTrak 3500 Plus. The Ethernet capability conforms to the ISO 802.3 standard.

Radiology

Surgical Navigation Systems use information from medical images to aid doctors during
surgery. Depending on the surgical procedure, a CT or MRI is obtained using the
scanning protocols provided in this Operator’s Manual. The axial scan is transferred to
the system, where the images are automatically reformatted into coronal, sagittal and
three-dimensional views.

Connectivity is the process of establishing communication between the scanner and the
InstaTrak® 3500 Plus. A GE Healthcare Field Service Engineer works with your
network administrator to establish a method for transferring the medical images to the
system. Refer to the Service section in the InstaTrak® 3500 Plus Operator’s Manual for
more information about connectivity.

Page 2-2

PRE-OPERATIVE

Transferring Scans To the InstaTrak
3500 Plus

There are a number of options for transferring scans to the system:

 A ConneCTstat™ Plus can be placed in a Radiology Department and connected to

your network. Images are transferred to the ConneCTstat™ Plus and sent to a CD,
which can then be inserted into the InstaTrak® 3500 Plus. This enables an outside
Radiology group to perform the medical imaging that will be used during surgery.

 The InstaTrak® 3500 Plus can be directly connected to the hospital network

enabling the scans to be transferred from the scanner to the system, which is
connected to the network in the OR. It is also possible to transfer scans between the
InstaTrak® Plus and the ConneCTstat™ Plus via a network connection.

 The InstaTrak® 3500 Plus can be transported to the Radiology Department and

hooked up to a network connection. Scans are transferred directly from the scanner
to the system.

 If the scanner has the capability to archive DICOM data onto a CD, then the scans

may be downloaded onto a CD directly from the scanner or Radiology workstation
and then loaded onto the InstaTrak® 3500 Plus.

The medical images used for surgical navigation must meet specific criteria. GE
Healthcare has developed protocols that must be followed in order to ensure high quality
images for use with the InstaTrak® 3500 Plus. The GE Healthcare Clinical Specialist
will work with your CT and/or MRI technologists to ensure that the protocols are
understood and followed.

Scanning Protocols

The scanning protocols are designed to meet the following goals:

• Maximize system accuracy during surgery

• Obtain Automatic Registration, when applicable

• Minimize scan time

• Minimize patient radiation exposure

• Optimize image quality

Page 2-3

PRE-OPERATIVE

Registration

Registration is the process of aligning the patient scan with the actual physical features of
the patient. For a more detailed description of registration, refer to System Operation in
the InstaTrak 3500 Plus Operator’s Manual.

A valid registration is necessary in order to use the system for surgical navigation.

Methods

Several different registration options are available with the Advanced ENT Application
of the InstaTrak® 3500 Plus:

• Automatic Headset registration - The headset is worn during the scan.

• Auto Plus registration – The headset is worn during the scan.

• Fiducial registration - Fiducial markers are placed on the patient before the

scan.

Fast Fiducial ™ is a computer algorithm to determine the position

and center of the fiducial marker

• AccuMatch™ Surface Registration (if system is equipped) - No markers are

placed on the patient.

Figure 2-1. Scanning/Surgery

Registration Methods and Scan Compatibility

• CT: All registration methods may be used

Page 2-4

PRE-OPERATIVE

• MRI: Fiducial or AccuMatch™ registration only.

Note: The headset contains embedded metal markers and may not be worn during an MRI

scan.

Page 2-5

PRE-OPERATIVE

Automatic Registration Headset

Headset Selection Guidelines

• For patients 14 years or older, use the Adult Headset

• For pediatric patients under the age of 14, head circumference must be

measured to determine the appropriate Pediatric Headset size.

• Measure the head circumference directly above the eyebrows used the tape

measure provided in each headset box.

Headset Description Reorder # Patient Head Circumference
Adult 100497 Adults and Children age 14 or over Greater than 57 cm
Pediatric Large 100948 Large Children Greater than 52 cm
Pediatric Small 100949 Small Children Less than 52 cm

Table 2-1. Headset Selection Guidelines

Note: Patients, 14 years or older with a head circumference less than 57 cm, may be better

suited for the Pediatric Large Headset. Pediatric patients, less than 14 years with a head
circumference greater than 57 cm, may be better suited for using the Adult Headset. We
recommend that the surgeon fit the Headset to the patient to ensure proper fit.

WARNING

Some patients may experience discomfort when the Headset is worn for an
extended period of time. Such discomfort should be temporary. Patients with
TMJ, impaired circulation, or other conditions that may be aggravated by use of
the Headset, should be given special consideration. Temporary pain or
temporary loss of sensation may be experienced with use of the Headset.

CAUTION

The use of the Headset is not recommended on patients less than three (3) years
of age unless a proper fit can be determined.

WARNING

The Headset is a single-use patient item. Using the same Headset on another
patient can result in system inaccuracy due to changes in Headset geometry
leading to a patient safety hazard.

CAUTION

Prior to scanning, ensure the small metal markers embedded in front and side of
the Headset are present. If any markers are missing, do not use the Headset.
Automatic registration is not possible if the markers are missing or are not
present on the CT scan.

Page 2-6

PRE-OPERATIVE

CAUTION

To maximize system and tracking accuracy, the Headset used during the CT
scan should be used in surgery. If a surgical fixation device, such as a Mayfield,
will be used, ensure that the Headset is positioned exactly as in the CT scanner.

Page 2-7

PRE-OPERATIVE

Verification Pad Placement

2 adult verification pads are provided in each Adult Headset box. 2 pediatric verification
pads are provided in each Pediatric Small Headset box. 2 adult and 2 pediatric
verification pads are provided in each Pediatric Large Headset box. The clinician must
select the appropriate Verification Pad for each patient.

The verification pad must be worn during the CT scan for patient comfort and to ensure
proper fit of the Headset. Place the verification pad on the patient’s nose by aligning the
upper center curve of the verification pad with the bridge of the patient’s nose.

Figure 2-2. Verification Pad Placement

Verification Pad

WARNING

The Verification Pad provided with the headset must be used to increase patient
comfort and to reduce the possibility of bruising of the skin under the nosepiece
of the Headset.

Page 2-8

Headset Placement

Select the appropriate Adult, Large Pediatric or Pediatric Headset. Gently set the
nosepiece on the bridge of nose and place each earpiece into the external ear canals.

Figure 2-3. Headset Placement

PRE-OPERATIVE

Tragus

WARNING

Store Headset only in the supplied box. Ensure that the Headset is positioned
properly in the box to maintain its shape. Failure to do so can result in system
inaccuracy due to changes in Headset geometry.

WARNING

The Headset is a single-use patient item. Using the same Headset on another
patient can result in system inaccuracy due to changes in Headset geometry
leading to a patient safety hazard.

Fiducial markers are used to correlate the scanned images with the patient. The fiducial
markers must be placed on the patient before the scan and must not be moved until after
the registration process in surgery is complete.

For best results, wipe the areas on which the fiducials are to be placed with alcohol to
remove oil. Place the fiducial markers on the patient according to the placement below.

Note: To ensure registration accuracy, once the fiducial markers are placed they cannot be

moved or replaced until the registration process is complete.

CAUTION

If a fiducial marker falls off, it must not be replaced. Replacing a fiducial marker
may result in registration inaccuracy.

Page 2-9

PRE-OPERATIVE

Fiducial Marker Placement Guidelines

• Place more fiducial markers than necessary in case one or more is displaced.

A minimum of four (4) fiducial markers is required for a relevant
registration.

• Surround the operative area and do not place too close together

• Apply to areas where the skin is relatively immobile.

• Apply to bony areas. Avoid areas where skin is loose.

• Apply within the medical images scanning range only.

• Do not apply to areas of trauma as swelling may displace their position.

• Do not apply fiducials in a straight line

For best results, GE recommends fiducial marker placement on the following areas:

• Above the eyebrow at the hairline

• Lateral forehead

• Vertex, slightly off the midline

• Asterion (junction of parietal, occipital and temporal bones)

• Above and behind the ear

Figure 2-4. Fiducial Marker Placement

CT Scanning Protocol

The following table provides CT scanner guidelines to obtain the best results for use with
the InstaTrak® 3500 Plus.

Keep all parameters consistent throughout the scan.

Page 2-10

Scanning Plane

Patient Position

Axial

Supine

PRE-OPERATIVE

Gantry Angle

Matrix Size 512

Slice Thickness 1-3mm

Scanning mode Helical

Table increment 1mm

Algorithm Standard brain

Table 2-2. Recommended CT Scanner Protocol

Zero

CAUTION

Scanner settings listed in bold print indicate that no changes are allowed. All
others may be set at the discretion of the user.

Patient Preparation

 Remove all metal from the patient’s head
 Place the fiducial markers or the Automatic Headset on the patient, as applicable
 Be certain to place the Verification Pad on the patient as directed before placing the

Headset

 Fiducial markers or the Headset are not required if AccuMatch™ Surface

Registration will be used

 Position the patient on the scanner table for a supine axial scan.

MRI Scanning Protocol

The following table provides MRI scanner setting-guidelines to obtain the best results for
use with the InstaTrak® 3500 Plus.

Scanning Plane

Patient Position

Data Acquisition

Matrix Size 256

Slice Thickness 1.5mm

Axial

Supine

3D Volumetric

Table 2-3. Recommended MRI Protocol

Page 2-11

PRE-OPERATIVE

CAUTION

Scanner settings in bold print indicate that no changes are allowed. All others
may be set at the discretion of the user.

Patient Preparation

• Remove all metal from the patient

• Place fiducial markers on the patient, if applicable

• Position the patient on the scanner table in the supine position

Scanning

• Use a protocol for T1 3D volumetric data or 3D reconstructions

• Scan using 1.5mm slice thickness with contiguous, non-overlapping slices

Images must be acquired in the axial plane.

− If the abnormal area is not clearly visualized, then the protocol should be

adjusted to use T2.

• Make certain that all of the requested anatomy appears on the scan

• If fiducial markers are used, all markers must appear on the scan

• If no markers were placed on the patient, the nose, ears, top of the head and

the back of the head must appear on the scan.

Note: The GE Healthcare Automatic Headset cannot be used during an MRI scan. If using a

MRI scan, fiducial or AccuMatch™ Surface Registration must be performed.

Page 2-12

GETTING STARTED

3

GETTING STARTED

HIPAA “Privacy Rule” Compliance

The InstaTrak® Plus Surgical Navigation System is compliant with the Privacy Rule, a
Federal regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 protecting the privacy of individually identifiable health information.

Users of the InstaTrak® Plus Surgical Navigation System have the option of assigning a
password before system operation and to de-identify patient data before copying.

Note: To protect sensitive healthcare information, GE Healthcare Technologies strongly

recommends requiring a password to operate the system and de-identifying patient data
before transferring or copying to a CD or floppy disk

Page 3-2

GETTING STARTED

Transferring Data

Scanner Transfer

The following instructions apply to transferring image data from either a CT or an MRI
scanner to either the InstaTrak® 3500 Plus or the ConneCTstat™ Plus. Refer to Service
in the InstaTrak® 3500 Plus Operator’s Manual for more details about connectivity.

Note: The System should be disconnected from the network connection before using in

surgery.

• Plug the system into a hospital-grade electrical outlet.

• Plug the network connector into the receptacle marked “Ethernet Port” on the

back of the system.

• Turn on the system.

• Wait for the MAIN MENU to appear.

CAUTION

Each scan requires approximately one hundred twenty-five (125) images of free
disk space. If disk space is unavailable, older scans must be deleted. See
System Operation in the InstaTrak® 3500 Plus Operator’s Manual for instructions
on how to delete images.

Network Transfer

After scanning is done and all reconstructions are complete, initiate the transfer between
the scanner and the InstaTrak® 3500 Plus. A menu appears showing the transfer status.

To end the transfer of a scan, select an entry while it is being transferred and then select
the Cancel button. Any scan that has already been transferred must be deleted manually
from the PATIENT DATABASE MENU.

Figure 3-1. Network Transfer Menu

Page 3-3

GETTING STARTED

Transferring Between Systems

A scan may be selected and transferred between InstaTrak systems via an Ethernet
network. Before beginning the transfer, ensure that both the InstaTrak® 3500 Plus or the
ConneCTstat™ Plus are connected to the hospital network and that both systems have
the same AE (Application Entity) Title.

Note: Only one scan may be selected and transferred at a time.

To transfer a scan between systems

• Plug in both systems and turn the power on.

• Select the PATIENT DATABASE button. The PATIENT DATABASE

MENU appears.

• Highlight the correct scan.

• Select the Send Data To…. button from the PATIENT DATABASE

MENU. The TRANSFER DATA MENU appears.

• Select the Network button from the TRANSFER DATA MENU. All the

DICOM Data Providers that are listed on the DICOM CONFIGURATION
MENU appear.

• Select the Host Name assigned to the receiving system.

• Select the Send button.

• A message appears to confirm the transfer. Select Yes to continue or No to

cancel the process.

Page 3-4

Selected
Patient
Scans

De-Identify

Button

GETTING STARTED

Transfer Data
Task Window

Send Data To…

Button

Eject Button

Figure 3-2. Transfer Data Between Systems

Page 3-5

GETTING STARTED

Transferring Using a CD

If a ConneCTstat™ Plus is in the Radiology Department, the CT or MRI scans can be
placed on a blank CD-R for transfer to the InstaTrak® 3500 Plus.

To load the CT or MRI scan for viewing or navigation purposes, the scan must first be
transferred to the system Hard Drive. Scans cannot be directly loaded from the CD.

Scans may be downloaded onto a CD and viewed on a PC. Refer to the InstaTrak® 3500
Plus Operator’s manual for more information on the DICOM CD Viewer.

Note: The InstaTrak® 3500 Plus or ConneCTstat™ Plus uses a CD-R that can be written to

one time only.

Note: Before copying patient data to a CD, the patient’s name can be de-identified. GE

Healthcare strongly recommends the de-identification of patient data before copying.

• There are three ways to open the CD drawer:

− The drawer will open on command when certain message windows are

selected.

− The button is pressed on the CD Drive.

− The Eject button is s elected from the PATIENT DATABASE MENU.

• There are two ways to close the CD drawer:

Hard Drive

Button

CD Drive

Button

− The drawer will close on command.

− The CD drawer is gently pushed to activate closing. Do not force the CD

drawer.

Page 3-6

Figure 3-3. Transferring Data Using A CD

GETTING STARTED

Transferring Scans: CD to Hard Drive

• Open the CD drawer and place the CD containing the scan into the drive.

• Close the CD drawer.

• Select the CD Drive button from the PATIENT DATABASE MENU.

• Highlight the desired scan (s). Multiple scans may be copied at the same time

as long as all scans are listed consecutively in the PATIENT DATABASE
MENU.

• Select the Send Data To… button. The TRANSFER DATA MENU appears.

Hard Drive is selected automatically.

• Select Send.

• A message window appears. Select Yes to confirm or No to cancel.

After the transfer process is complete, select the Hard Drive button to confirm that the
scan was successfully transferred.

Hard Drive to CD

From the PATIENT DATABASE MENU, select the desired scan (s). More than one scan
can be copied at one time. Snapshots appearing in the database can be included in a
series.

• If the scans are listed consecutively, highlight one and drag the cursor to the

next until all scans or snapshots to be copied are highlighted.

• If the scans are not listed consecutively, and a keyboard is attached to the

system, highlight a scan, then select and hold down the Control button on
the keyboard. Highlight the other scans or snapshots until all items to be
copied are highlighted.

• Select the Send Data To…. button from the PATIENT DATABASE

MENU. The TRANSFER DATA task window appears. CD Drive is selected
automatically.

Note: To remove the patient name from the copied data, select the De-Identify Data button.

The De-Identify task window appears allowing you to select a new identifier for the
patient.

• Select the Send button.

• Select Yes to confirm or No to cancel the copying process.

• If Yes is selected, the CD drawer opens automatically.

• If a blank disk is inserted in the CD drive, select Continue. The CD drawer

will automatically close

• Select Cancel to cancel the copy process

• Note the amount of data to be copied and verify that there is sufficient space

on the CD. You must use a blank CD-R.

Page 3-7

GETTING STARTED

.

Figure 3-4. Sufficient CD Space Message

 If the highlighted series of scans and snapshots are correct, select Yes. The CD

copying process begins automatically

Figure 3-5. Confirm CD Copy Message

 When the transfer process is complete, the CD Complete message appears. Select

OK.

Figure 3-6. CD Complete Message

When the CD copying process is complete and the OK button is selected, the CD drawer
opens automatically.

To confirm that the scan has been copied onto the CD, close the drawer and select the CD
Drive button on the PATIENT DATABASE MENU. The copied scans and snapshots
appear on the PATIENT DATABASE MENU. To remove the CD, select the Eject
button.

Page 3-8

GETTING STARTED

Auto Registration Verification

Figure 3-7. Auto Registration Column

If the patient’s CT scan was performed using a Headset, an automatic registration may be
used. To verify that automatic registration may be used:

• From the MAIN MENU, select the Patient Database button. The PATIENT

DATABASE MENU appears.

− The Auto Reg column on the far right of the PATIENT DATABASE

MENU provides information on the status of Automatic Headset
Registration.

− If Yes appears in the Auto Reg column, then Automatic Headset

Registration can be used.

− If No appears in the Auto Reg column, either the Automatic Headset

Registration was not successful, the Headset was not used during the

patient scan, or the embedded fiducial markers were not present in the
scan volume.

Note: If an Automatic Headset Registration is not possible as indicated by a No in the Auto

Reg column, an AccuMatch™ Surface Registration, automatic fiducial registration (if at
least 5 marker balls are present on the patient scan), or fiducial registration (if patient
was scanned with fiducial markers) may be performed.

Page 3-9

GETTING STARTED

CAUTION

If dashes appear or anything other than Yes or No is listed in the Auto Reg
column, the scan was not done to protocol and cannot be used in surgery with
the InstaTrak 3500 Plus.

Note: The automatic registration status will not appear on the CD. The Auto Reg column for

the patient scan will display “- - -“. To verify automatic registration, check the status of
the scan on the hard drive. When the scan is transferred to the Hard Drive, post­processing will reinitiate and the correct auto registration will reappear.

Page 3-10

4

OPERATING ROOM

OPERATING ROOM

Operating Room Setup

HIPAA “Privacy Rule” Compliance

The InstaTrak® Plus Surgical Navigation System is compliant with the Privacy Rule, a
Federal regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 protecting the privacy of individually identifiable health information.

Users of the InstaTrak® Plus Surgical Navigation System have the option of assigning a
password before system operation and to de-identify patient data before copying.

Note: To protect sensitive healthcare information, GE Medical System strongly recommends

requiring a password to operate the system and de-identifying patient data before
transferring or copying to a CD or floppy disk

Logon and Logout

Since the system contains sensitive patient data, you have the option of requiring users to
Logon to the system and to Logout when system use is complete. The Logon process
requires a password (default or selected by you) when the system is powered on. When
finished using the System, you have the option to logout or shutdown. The System
shutdown and logout process is covered in the Post-Operative section of this Operator’s
Manual and in the InstaTrak 3500 Plus Operator’s Manual.

Password Protection

Upon installation, the InstaTrak® Plus Surgical Navigation System is protected with a
default password. The password is required to operate the system. If desired, you can
change or eliminate the password. Since the system contains sensitive patient
information, GE Healthcare strongly recommends that the password requirement not be
eliminated.

Powering and Logging On To The System

The system should be positioned in the Operating Room so that the surgeon can easily
see and reach the display. If the operative area is crowded, the articulating arm can be
extended. If you want to interact with the display during the surgical procedure, a
sterilizable stylus is supplied or the display can be covered with a sterile drape.

• Plug the system into a grounded hospital grade outlet. Disconnect the system

from the network connection, if applicable.

• Turn on the power switch (bottom center of unit). After a short period of

time, the Logon menu will appear:

Page 4-2

OPERATING ROOM

Figure 4-1. Log-on Menu

• The Logon Name is genav and appears automatically.

• Enter the password. The default password is tmp123 but may have been

changed by your System Administrator or Biomedical Department.

Note: If you do not know the password, contact your hospital’s System Administrator or

Biomedical Department.

• When the correct password is entered, the MAIN MENU appears.

Page 4-3

OPERATING ROOM

Changing The Password

If you want to change the password:

• Select the Change Password button. The CHANGE PASSWORD TASK

WINDOW appears:

Figure 4-2. Change Password Task Window

Note: To change the password, the current password must be entered. The default password is

tmp123. If you do not know the password, contact your hospital’s System

Administrator or Biomedical Department.

• Enter the Logon Name: genav, and enter the current and new password.

When completed, select OK.

• Enter the new password into the LOGIN TASK WINDOW

• Select the Login button and the MAIN MENU will appear.

Page 4-4

OPERATING ROOM

Disabling the Logon Requirement

You have the option to eliminate the Logon-with-password requirement and may choose
to retain the patient’s name on copied scans and snapshots. To choose these options:

• Select System Administration from the MAIN MENU

System Administration
Button

Figure 4-3. System Administration Button

• Select User Options. The USER OPTIONS TASK WINDOW appears.

Page 4-5

OPERATING ROOM

User Options

Task Window

User Options

Button

Figure 4-4. User Options

• Select Remove User Login/Logout.

Note: GE Healthcare strongly recommends requiring users to log in and out of the system with

a password and not automatically displaying the patient’s name on snapshots

Page 4-6

OPERATING ROOM

Copying Sensitive Patient Data

Patient snapshots can be copied to a floppy disk or CD. Unless the patient identifiers are
removed, the snapshots contain the patient name. The patient identifier can be replaced.

Copying snapshots to a Floppy Disk or CD

• Select the snapshot images to copy from the PATIENT DATABASE MENU

• Select the View Snapshots button or double-click on the patient’s name. The

IMAGE PREVIEW MENU appears:

De-Identify

Button

Copy Images to
Floppy or CD
Buttons

Border Around Snapshot

Figure 4-5. Image Preview Menu

• Select anywhere on the image by touching the screen or clicking with the left

mouse button. The border of the image turns green meaning that the image is
selected.

• Select Next or Previous to view and choose individual images or Select All

to copy the entire series.

Before copying the images, you have the option to remove the patient identifier
on the copied images. To remove the patient identifier, select De-Identify Data.

Page 4-7

OPERATING ROOM

De-Identify Data
Task Window

Figure 4-6. De-Identify Data Window

The DE-IDENTIFY DATA WINDOW displays the Original Name and a New
Name consisting of pre-selected letters and numbers. If desired, input a New
Name.

• When completed, select Continue.

• To continue copying, select Copy Images to Floppy.

Page 4-8

OPERATING ROOM

ElectroMagnetic Tracking Guidelines

The InstaTrak™ 3500 Plus utilizes an electromagnetic tracking system. For best results,
you must be aware of the amount of metal in the operative area and try to eliminate
ferrous metal placed between the transmitter and receiver.

Standard operating room equipment and techniques should be used along with the
following recommended guidelines for reducing the amount of ferrous metal in the
operative area.

• Select a radiolucent OR table whenever possible. If using a metal OR table,

place an extra mattress pad on the table.

• Use plastic clips for securing surgical drapes

• Place intubation tube holder and Mayo stand at least 12 inches away from the

operative area

• Position the InstaTrak® 3500 Plus so that it is at least 3 feet away from the

transmitter

• When metal instruments such as a speculum or retractors are required, ensure

that they are non-ferrous. Non-ferrous instruments are supplied by GE
Healthcare. For more information, see your GE Healthcare Technologies
Representative.

• The system displays a message if the field is distorted or excessive metal is

detected.

WARNING

Do not ignore any field distortion messages. When the field is distorted or
excessive metal is detected, accuracy can be affected that can lead to a patient
hazard.

WARNING

When instruments, such as mouth gag, nasal speculum or retractors, are used
ensure they are made from low content metal or non-magnetic materials. These
instruments may be obtained from GE Healthcare. Failure to use non-magnetic
instruments may decrease accuracy or result in an inoperable system.

CAUTION

Notify GE Healthcare if any red warning message occurs repeatedly without an
apparent cause or cannot be eliminated by the user.

Page 4-9

OPERATING ROOM

Standard ENT Equipment and Instruments

The following lists equipment and instruments generally used for ENT and skull-base
surgical navigation procedures. The list should be used as a guide only.

Figure 4-7. Aspirators

• Headset, Adult or Pediatric

• Aspirator(s):

− 7 F or 10 F

− Extended Straight

− 15 Degree, 45 Degree, 90 Degree

• Debrider Attachment

• Button Probe, non-sterile, if AccuMatch™ surface registration is desired

• Transmitter

• One or Two Receivers

Note: GE Healthcare Technologies strongly recommends sterilizing the receivers before use.

Page 4-10

Transsphenoidal Procedures

• Automatic Headset, Adult or Pediatric

• Verification Pad, Adult or Pediatric

• Extended Straight Aspirator

• 3M 1010 Steri-Drapes or other clear plastic drape for the Headset

• Button Probe, non-sterile, if AccuMatch™ surface registration is desired

• Nasal Speculum, non-ferrous metal

Skull-base Procedures

• Axcess™ System for unrestricted surgical approach. For procedures when

the use of the headset is not possible. Refer to the Axcess System Operator’s
Manual for complete details.

• Non-sterile Pointer or Button Probe for registration process

• Nasal Speculum (optional)

OPERATING ROOM

Figure 4-8. Button Probe

Figure 4-9. Axcess System

General and Optional Equipment and Instruments

• Button Probe if using optional AccuMatch™ surface registration

• Calibration Post for calibrating the Gyrus Diego or Stryker Debriders

• Flat Panel Sterile Drape for display

• Fiducial markers if using MRI and fiducial registration is desired

Page 4-11

OPERATING ROOM

• Camera drape bags for the receiver, if sterilization is not possible

• Composite or S-video cable to connect to endoscope or microscope

• Video Scan Converter/Recorder

Note: No natural rubber latex is used in any GE Healthcare Technologies product or

packaging.

WARNING

Only surgical instruments or attachments to instruments supplied or
recommended by GE Healthcare will provide the level of accuracy specified by
this System. We cannot guarantee the accuracy with instruments that are not
recommended by GE Healthcare and using such instruments might compromise
the accuracy leading to a potential patient hazard.

CAUTION

Do not connect any equipment that is not specifically described in this manual to
the System. Whenever AC powered equipment is connected to the System, the
user must confirm that applicable standards for leakage current are met by the
interconnected system.

CAUTION

Due to the magnets in the Instruments, do not put magnetic media, such as a
floppy disk, near any of the Instruments as the data could be erased.

Page 4-12

OPERATING ROOM

Setting Up The InstaTrak 3500 Plus

Refer to System Operation in the InstaTrak® 3500 Plus Operator’s Manual for more
detailed instructions.

Note: Select refers either to touching the touch screen with a finger or a pointer or clicking

with the computer mouse.

WARNING

The Network Connection must be unplugged before the InstaTrak® 3500 Plus is
placed in the vicinity of a patient. Not unplugging the network connection could
cause a potential patient hazard.

After turning on the InstaTrak® 3500 Plus and entering the Logon information, the
MAIN MENU appears.

Figure 4-10. Main Menu

• Attach the transmitter and a receiver to the front of the InstaTrak® 3500

Plus.

If a video display of the microscope or endoscope camera is desired on the system
during the surgical procedure, a connection must be made between the endoscopic
camera and the InstaTrak®3500 Plus using composite or S-video cable.

Page 4-13

OPERATING ROOM

To establish the link between the system and the microscope or endoscope
camera:

− Plug one end of either a composite cable or an S-Video cable into the

appropriate Video In connector on the back of the system.

− Plug the other end of the cable into the output on the microscope or

endoscopic system.

Loading Images

After selecting the Patient Database button from the MAIN MENU, the PATIENT
DATABASE TASK WINDOW is displayed.

Patient

Scans

Application
Selection

Load

Button

Figure 4-11. Patient Database Menu with Application Selections

Note: If using a CD as the method for transferring the scans, the scan must be transferred to the

Hard Drive before loading.

• Select the patient’s scan from the PATIENT DATABASE.

• Select the Load button.

• If you are using the mouse, you can also double-click on the scan to load it.

Page 4-14

OPERATING ROOM

Post processing is the process of formatting the scan and may be required before the scan
can be loaded. If so, the Post processing Message appears.

Figure 4-12 Post Processing Required Dialog

• Select OK to post process the images. Once post processing is complete, you

must select the Load button to load the scan.

• Select Cancel to stop the post processing procedure.

• Once the Load button is selected, a confirmation message will appear. This

enables you to verify that the correct scan has been selected.

• Select Yes to confirm

Note: Unless Image Fusion is available on your InstaTrak 3500 Plus, only one scan can be

loaded at a time.

• If a scan is already loaded, a message appears to confirm that you will be

replacing the existing scan with the new scan.

• Select Yes to confirm

Note: Replacing one scan with another will not delete the previously loaded scan.

Page 4-15

OPERATING ROOM

• Select the correct Application, such as Advanced ENT

The following message appears indicating that the scan is being loaded.

Visualization Display

After loading the patient scan, the VISUALIZATION MENU appears.

Message

Center

Figure 4-13. Visualization Menu

The Message Center displays important or informative messages. The messages
indicate tasks that need to be completed in order to initiate tracking or they indicate the
status of the system. The message background will be red or yellow depending on the
status or severity. Red messages must be responded to immediately and always indicate
a severe problem or urgent condition.

The icons on the bottom right of the Display enable quick access to display adjustments.

Page 4-16

OPERATING ROOM

Figure 4-14. Display Adjustment

The icons are:

1. Snapshot

2. Brightness and Contrast

3. Crosshair Adjustment

4. Zoom

1 2 3 4

Page 4-17

OPERATING ROOM

Snapshot

The Camera icon enables a snapshot to be taken at any time during the

procedure. When selected, a bright light indicates that a snapshot is being
taken. The snapshot is available in the PATIENT DATABASE and can be
stored, viewed, or copied to a floppy disk or CD.

Contrast/Brightness Adjustment

The Contrast/Brightness icon enables adjustment to the appearance of the

display. To make adjustments, select the contrast/brightness icon. When
selected, the IMAGE CONTROLS TASK WINDOW appears on the left side
of the display.

Contrast and
Brightness Sliders

Scan Opacity Slider

Figure 4-15. Image Picture

• To adjust the contrast and/or brightness of the scan, use the sliders.

• Select Close when adjustments are complete.

Note: The Scan Opacity slider and Color Map selector are useful with the Image Fusion

option. See the Image Fusion Operator’s Manual for more information.

Page 4-18

Crosshair Adjustment

The tip of the surgeon’s instrument will appear on the Visualization display’s

orthogonal views as a crosshair. By selecting the Crosshair icon, the
appearance can be changed.

OPERATING ROOM

Figure 4-16. Crosshair Adjustment

The Crosshair Adjustment choices are:

• 5 mm scale - crosshairs with tick marks every 5 mm

• Plain – crosshairs with no tick marks

• Target – Places a small, yellow cross at the target location

• None - no crosshairs appear on the scan

Crosshair Adjustment

Page 4-19

OPERATING ROOM

Zoom Control Adjustment

The displayed scan size can be made larger or smaller by selecting the Zoom

Controls icon. When the size is selected, all orthogonal displayed views are

adjusted.

Figure 4-17. Zoom Control

The Zoom Control choices are:

• 1:1 magnification

• 2:1 magnification

• 4:1 magnification

Zoom

Zoom

Control

Control

Page 4-20

Display Layouts

Orthogonal Views

Medical scans can be viewed directly on the InstaTrak® 3500 Plus. The axial scan is
loaded into the system and reconstructed into coronal and sagittal views. The 2D axial,
sagittal, and coronal views are termed orthogonal.

You can scroll through the scan using the Arrow buttons to view the scan sequentially or
click within the two-dimensional (2D) images or the three-dimensional (3D) model to
locate a point of interest.

OPERATING ROOM

Up and Down

Up and Down
Arrows

Arrows

}

Figure 4-18. Up and Down Arrows

To view a point of interest, position the cursor on an orthogonal image and click with the
left mouse button. The other views automatically display the same image point.

If you want to view the scan without the crosshairs, the crosshairs can be removed by
selecting None from the Crosshair icon on the display.

Page 4-21

OPERATING ROOM

3D Surface Model

The 3D model may be manipulated and adjusted by using the icons on the right of the 3D
model.

Expand 3D
Model Button

Figure 4-19. Surface Model Adjustment

To access these capabilities, select the icon.

1.

2.

3.

4.

5.

3D Surface and
Adjustment
Icons

Page 4-22

6.

1. Opacity of 3D model surface. This button is used most frequently with the

Auto-Segmentation. Available with the Cranial Application only.

OPERATING ROOM

2. Point to quickly view a point of interest on the model.

3. Rotate to turn the 3D surface model.

4. Zoom to enlarge or shrink the size of the model.

5. Position to move the model side-to-side and up and down.

6. Reset to quickly adjust the model to default, face-front position.

Expand Button

The 3D model can be expanded to full screen by selecting the Expand button at the top
right of the 3D model. When the 3D Model is expanded to full screen, the button changes
to Shrink to exit the full screen mode.

Page 4-23

OPERATING ROOM

Tracking and Surgical Review Views

Different surgical review or tracking views can be selected for each quadrant. A different
view may be selected and changed at any time. The current selection can be seen in the
top left of every quadrant. The views selected at the end of the procedure are stored
when the InstaTrak® 3500 Plus is shut down and displayed during the next use of the
system.

To change the view, select the button at the top left of the quadrant. A pull-down menu
appears enabling you to change the layout for surgical review or tracking. Each quadrant
layout must be changed individually.

Figure 4-20. View Selection Pull Down Menu

Page 4-24

Surgical Review Views

Selecting Surgical Review enables you to select a view when not tracking. The view can
be changed at any time. You can select a view for each quadrant.

OPERATING ROOM

Figure 4-21. Surgical Review Pull Down Menu

The Surgical Review view choices are:

• Coronal

• Axial

• Sagittal

• 3D Surface Model

Page 4-25

OPERATING ROOM

Tracking View Views

Selecting Tracking View enables you to select a view for tracking. The view may be
changed at any time. You must select a view for each quadrant.

The available Tracking Views are determined by the instrument to be used during
tracking. You must select either Probes or Instruments before selecting a Tracking
View.

Figure 4-22. Probes or Instruments Pull Down Menu

Probes are any instrument where a trajectory may be displayed. Examples are the
pointer. Oblique Views are available when Probes is selected.

Instruments are any instrument without a trajectory. An example is an Aspirator.

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If Probes are selected, you can choose a Tracking View from the pull-down list.

Figure 4-23. Tracking View Pull Down List - Probes

The available Tracking Views for Probes are:

• Coronal

• Axial

• Sagittal

• 3D Surface

• Axial Oblique

• Sagittal Oblique

• Perpendicular Oblique

• 3D Surface with Axial Oblique

• 3D Surface with Sagittal Oblique

• 3D Surface with Excavate Brick

• Video

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OPERATING ROOM

If Instruments are selected, you can choose a Tracking View from the pull-down list.

Figure 4-24. Tracking View Pull Down List - Instruments

When Instruments is selected, the layout choices are:

• Coronal

• Axial

• Sagittal

• 3D Surface

• 3D Surface with Excavate Brick

• Video

Note: Once the tracking views for either Probes or Instruments are set, they will automatically

appear whenever the applicable instrument is tracked.

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OPERATING ROOM

Using the Automatic Registration
Headset

Attaching Transmitter to the Headset

The Automatic Registration Headset may be used for procedures where access to patient
anatomy will not be obstructed by use of the Headset. When AccuMatch™ surface
registration is preferred, the Headset can also function simply as a Transmitter
attachment device.

Figure 4-25. Attaching Transmitter to the Headset

• Align the rotating latch on the transmitter to the slot on the Headset.

• Insert the transmitter into the slots in the Headset.

• Secure the transmitter to the Headset by rotating the latch to lock into place

of the transmitter.

WARNING

These instructions must be followed for use of the Automatic Headset. Failure to
follow these instructions may impact System accuracy leading to a potential
safety hazard.

Attaching the Verification Pad

The Verification Pad must be used with the Automatic Headset. Two pads are provided
in each headset box. The Verification Pad improves patient comfort and system
accuracy.

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OPERATING ROOM

• Place a Verification Pad on the patient’s nose after wiping the area to remove

dirt and oils.

• Peel the backing from the Verification Pad to expose the adhesive.

• Align the upper center curve of the Verification Pad with the bridge of the

patient’s nose. Place the verification point on the bony part of the nose. The
verification point should be accessible after the headset is in place.

Upper Center Curve

Verification Point

WARNING

To ensure system accuracy the Verification Pad must be used during the CT
scan and the surgical procedure.

WARNING

Use the cushioned Verification Pad provided with the Headset to increase patient
comfort and to reduce the possibility of bruising to the skin.

Placing the Automatic Headset

Tragus

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OPERATING ROOM

• Place the Headset on the patient by expanding the earpieces and positioning

the nosepiece into the deepest notch of the bridge of the nose. Do not pull or
displace the skin

• Align the earpieces over the patient’s ear canals and behind the tragus.

• Slowly allow the earpieces to work into the deepest portion of the ear canal.

Be sure that any accuracy markers used do not change position as the
Headset is placed on the patient.

WARNING

If head stabilization is required, ensure that the head frame does not displace,
press, or pull on the Headset. Displacement of the Headset may cause system
inaccuracy leading to a potential safety hazard.

WARNING

Some patients may experience temporary discomfort, pain, or loss of sensation
when the headset is worn for an extended period of time. Patients with TMJ,
impaired circulation, or other conditions that may be aggravated by use of the
headset, should be given special consideration.

WARNING

A headset must only be used with one patient. Using the same headset with
different patients can result in system inaccuracy due to changes in headset
geometry resulting in a potential safety hazard.

WARNING

To maximi ze System and tracking accuracy, the same headset used during the
CT scan should be used in surgery. A Verification Pad must be used if one was
used during the CT scan.

Draping

When draping the patient, use only lightweight plastic draping to avoid displacing the
Headset. Ensure that the Lateral Markers on the side of the Headset are easily accessible
for registration.

WARNING

When draping the headset prior to surgery, do not allow the draping to distort or
pull on the headset. This can result in system inaccuracy leading to a potential
safety hazard.

If using AccuMatch™ surface registration, an unsterile receiver and Button Probe will be
used for the registration process. The receiver used for the surgical procedure, should be
sterilized before use. If sterilization is not possible, the receiver must be completely
covered with a sterile camera or laser drape bag to maintain sterility. Place the camera

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OPERATING ROOM

drape bag over the Receiver, smooth out any wrinkles in the bag at the attachment point
of the Instrument.

CAUTION

If tape or other restraining devices are used to help hold the camera drape bag in
place, care must be taken not to impede or prevent the exchange of the
instruments.

If desired, the Display Touch Screen may be fully draped. Draping the Display Touch
Screen enables the surgeon to interact with the System during the surgical procedure.

Using Transmitter Arm Attachment

If using cranial stabilization, the transmitter may be attached to the cranial stabilization
system. The transmitter must be securely attached in the surgical field before the
registration process can occur. The transmitter can be attached by using one of the three
devices available with the InstaTrak 3500 Plus:

 Transmitter Attachment Arm for use with the Mayfield

System

®

Cranial Stabilization

 Universal Transmitter Attachment Arm for headframes other than the Mayfield®.
 Automatic Registration Headset

If the surgery is performed using a head frame system, such as the Mayfield, the patient
should be positioned before attaching the transmitter.

If the Headset will be used, immobilization of the head is not required since the
transmitter is attached to the Headset.

The patient should not be draped until after the registration process is complete.
Transmitter attachment, instrument calibration and registration are performed in a non­sterile environment.

Attaching the Transmitter Arm to the Mayfield® Cranial
Stabilization System

GE Healthcare Technologies has designed a transmitter attachment arm that connects
specifically to the Mayfield® Cranial Stabilization System.

• Position the patient’s head securely in the Mayfield headframe.

• Insert the starburst connecter of the transmitter attachment arm into the

starburst connector of the Mayfield.

• Tighten using the handle until the teeth of the connector are locked and the

transmitter attachment arm is securely attached.

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OPERATING ROOM

Figure 4-26. Starburst Connector

• Position the transmitter attachment arm so that it will not be intrusive.

• Position the transmitter attachment arm so that the transmitter will be located

no more than ten (10) inches away from the surgical site.

• While holding the transmitter Arm in the desired location, tighten the two (2)

additional clamps. The clamps must be very tight to ensure there is no
movement and that the transmitter arm is as rigid as possible.

Figure 4-27. Positioning of Transmitter Arm

with Transmitter less than 10” from Surgical Site

WARNING

Any movement of the transmitter arm after the registration process will cause
inaccuracy that might lead to a potential safety hazard. Ensure that the
transmitter arm is securely attached and will not be bumped during the surgical
procedure.

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OPERATING ROOM

Attaching the Transmitter to the Transmitter Arm

The transmitter is attached to the transmitter arm by aligning the transmitter’s rotating
latch to the slot in the transmitter arm.

Figure 4-28. Align Transmitter Latch with Slot

• Insert the transmitter into the corresponding slot in the transmitter attachment

arm

Figure 4-29. Rotate Transmitter Latch to Secure Transmitter

• Rotate the latch on the transmitter to lock it and to prevent it from slipping

CAUTION

If the Transmitter Arm is not completely rigid, registration accuracy might be
compromised.

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OPERATING ROOM

Attaching the Universal Transmitter Arm

The Universal Transmitter Arm may be used if a surgical headframe other than the
Mayfield® Cranial Stabilization System is used. The Universal Transmitter Arm is
designed to attach to any headframe or stabilization system.

• Attach the clamp on the Universal Transmitter Arm to the head frame at a

point of adequate grip. The transmitter must be positioned within ten (10)
inches of the surgical site

• Tighten all of the clamps on the Universal Transmitter Arm.

• Open the latch on the Universal Transmitter Arm and insert the transmitter

CAUTION

Headframes constructed of radiolucent materials may be damaged by over
tightening of the universal clamp.

Draping

If using either the transmitter attachment arm for the Mayfield® or the universal
transmitter arm, drape the patient in the usual manner, with the following adjustments:

Figure 4-30. Open Latch -- Insert Transmitter -- Close Latch

• Close the latch. If the transmitter does not fit securely, turn the knob on the

transmitter arm in small increments to tighten the attachment.

• Place a clear cassette or camera drape bag over the transmitter attachment

arm.

• Cut a small hole in the drape to allow access to the transmitter for calibration

purposes.

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OPERATING ROOM

Figure 4-31. Transmitter and Attachment Arm Draping

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OPERATING ROOM

Attaching an Instrument

Note: All instruments should be sterilized before use.
Note: Multiple sterilization cycles may cause discoloration of the plastic components. This is

normal and will not affect the performance of the device.

The InstaTrak® 3500 Plus automatically will detect which instrument is attached to the
receiver. Confirm that the correct instrument type is indicated before using the
instrument. The Button Probe will be identified as a Pointer.

CAUTION

Prior to each use, visually inspect all Instruments and docking stations. Discard if
they are visually distorted or broken.

Attaching a Pointer

The pointer is supplied in a sterile package and may be used one time only during
surgery. The exception is the Pointer used only for registration purposes. This pointer
may be reused but must be cleaned and sterilized between uses as recommended.

These instructions apply to the pointer and to the button probe and may be followed in
any order, that is, the instrument may be attached to the docking station before attaching
to the receiver.

• Insert the back of the docking station into the slot on the receiver and gently

press until the receiver is locked into the docking station

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• Align the notch on the instrument with the channel on the docking station.

Be certain that the non-functioning suction hole is facing up and magnetic
detectors are facing the receiver.

 Snap the instrument into the docking station

CAUTION

Do not use the instrument if the package has been opened or damaged.

Using the Button Probe, P/N 1003632

Note: The following assembly instructions apply only to the Button Probe, P/N 1003632. The

newer version of the Button Probe, P/N 1006909, does not require assembly.

The button probe, P/N 1003632 must be assembled before using.

• Insert the button lever through the button hole.

Figure 4-32. Insertion of button lever

• Squeeze the tabs of the button lever then insert the pivot pins into the pivot

holes.

Page 4-38

• Attach the button probe to the receiver using the instructions for attaching an

instrument shown above.

OPERATING ROOM

CAUTION

Sterilization of the Button Probe should be limited to ten cycles.

CAUTION

Prior to each use, visually inspect the Button Probe and the docking station.
Discard any part that is visually distorted, broken and/or in which the probe is no
longer seated securely within the molded handle.

Note: Multiple sterilization cycles may cause discoloration of the plastic components. This is

normal and will not affect the performance of the device.

CAUTION

Both versions of the Button Probe and docking station must be cleaned and
sterilized prior to each use, if using during the surgical procedure.

Nasal Speculum

When using the System in conjunction with a surgical microscope, it is recommended that
you use GE Healthcare’s Nasal Speculum or other titanium or non-magnetic speculum

CAUTION

For optimal system accuracy, the hinge of the speculum should be positioned
away from the patient’s nose.

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OPERATING ROOM

Debrider Attachments

The Debrider Attachment is a device that provides a means of attaching the receiver to
almost any of the standard microdebriders being used in sinus surgery. This enables the
InstaTrak 3500 Plus to track the location of the tip of the microdebrider.

Compatible Microdebriders:

• Gyrus Diego™ Powered Dissector

• Gyrus Turbo 7000

• Smith and Nephew ESSential

• XOMED

• XOMED

• Stryker

• Stryker

• Linvatec E9000

®

STRAIGHTSHOT®

®

MAGNUM™

®

Hummer 2

®

Hummer TPS debriders

™

High Speed Shaver Handpiece.

®

Shaver Handpiece

Note: The Debrider Attachment, along with debrider, must be cleaned and sterilized before

use. The Receiver may be sterilized, if desired. Sterilization guidelines may be found in
the InstaTrak 3500 Plus Operator’s Manual. If not sterile, cover the Receiver with a
sterile camera drape bag.

WARNING

When using the debrider, the system should be used for localizing only. Do not
attempt to track with the system while debriding. Tracking while debriding may
result in unintended tissue removal.

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OPERATING ROOM

Gyrus™ Diego™ Powered Dissector

Components

 The Front Ring Assembly consists of the Receiver Attachment, Position Adjustment

Arm, Position Adjustment Screw and the Front Ring.

 Back Ring, with attached screw
 Calibration Post
 Allen wrench, with small and large ends

Figure 4-33. Gyrus Diego Powered Dissector, Unassembled

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OPERATING ROOM

Assembly

• Slide the Front Ring Assembly onto the Gyrus Diego dissector.

• Slide the Back Ring onto the dissector.

• Line up the screw on the Back Ring with the Front Ring Assembly. Use the

large end of the Allen wrench to tighten the attached screw until there is no
movement between the dissector and the attachment. Verify that the
attachment is securely fitted to the dissector by applying a side-to-side force
to the attachment. If the Attachment is loose, tighten the screw.

• The Gyrus Diego Powered Dissector Attachment may be attached to the

Gyrus Diego Powered Dissector in one of three positions: right, left or
center. Figure 4-34 shows the attachment in the center position.

Figure 4-34. Gyrus Diego Powered Dissector, Assembled

To change the position of the Receiver Attachment:

• Remove the Position Adjustment Screw from the Front Ring Assembly by

using the small end of the Allen wrench.

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OPERATING ROOM

• Move the Receiver Attachment into one of the three ratcheted positions.

• Replace the screw into the hole and tighten with the Allen wrench.

After the attachment is firmly connected to the Diego dissector, the receiver may be
attached to the Gyrus™ Diego™ Powered Dissector Attachment.

• Snap the attachment onto the receiver foot-first in the same manner as

attaching the Docking Station to the receiver. The system will automatically
detect that a debrider/ dissector is attached.

Disassembly

The Diego Powered Dissector Attachment must be removed from the Diego dissector
before cleaning and sterilization. The Front Ring Assembly must be removed from the
Back Ring, but the Front Ring Assembly may remain as one piece and does not have to
be dismantled prior to sterilization.

• Use the large end of the Allen wrench to loosen the screw on the Back Ring.

The screw is permanently attached to the Back Ring and may not be
removed.

• Slide the Back Ring off of the dissector.

• Remove the Front Ring Assembly.

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OPERATING ROOM

Gyrus Turbo 7000 Debrider

Figure 4-35. Debrider Attachment to the Gyrus TURBO 7000 Debrider

• Unscrew the knob on the Debrider Attachment to open the clamp. It is not

necessary to completely remove the knob from the clamp.

• Attach the Debrider Attachment to the Turbo 7000 Debrider by placing the

clamp around the midsection of the debrider, close to the front of the
debrider. The word Blade on the Debrider Attachment must face the cutter
blade. Position the Debrider Attachment directly above the suction tube.

• Align the knob with the mating threads on the clamp. Turn the knob

clockwise to tighten.

• Verify that the Debrider Attachment is securely fitted to the debrider by

applying a side-to-side force to the Debrider Attachment. If the Debrider
Attachment is loose, tighten the thumbscrew. The Debrider Attachment must
not be loose or be able to move.

• Snap the Snap-on Receiver onto the top platform of the Debrider

Attachment, similar to attaching the receiver to the Docking Station of an
aspirator. The InstaTrak 3500 Plus will automatically detect that the debrider
is attached to a receiver.

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OPERATING ROOM

Gyrus (Smith and Nephew) ESSential® Shaver
Handpiece

Figure 4-36. Debrider Attachment Attached to the Gyrus ESSential Shaver Handpiece

• Unscrew the knob on the Debrider Attachment to open the clamp. It is not

necessary to completely remove the knob from the clamp.

• Attach the Debrider Attachment to the ESSential Shaver Handpiece by

placing the clamp around the midsection of the debrider. The word Blade on
the Debrider Attachment must face the cutter blade. Position the Debrider
Attachment above the suction tube.

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OPERATING ROOM

XOMED® STRAIGHTSHOT® and MAGNUM™
Debriders

Figure 4-37. Debrider Attachment to the XOMED STRAIGHTSHOT Debrider

• Attach the Debrider Attachment to the STRAIGHTSHOT or MAGNUM

Debrider by placing the vise around the midsection of the debrider. The
word, Blade, on the Debrider Attachment must face the cutter blade. Position
the Debrider Attachment at a comfortable angle on the debrider. The
recommended position is forty-five degrees (45°) to the right of the handle
with the top indicated by the suction tubing. This position generally allows
the least interference with an endoscope during the surgical procedure.

• Press and turn the thumbscrew on the Debrider Attachment clockwise to

secure the Debrider Attachment into place. Tighten until the end of the screw
fits securely into one of the grooves on the debrider.

Note: To prevent accidental disengagement and movement during use, the thumbscrew is

equipped with a positive engagement feature. To turn the thumbscrew, apply downward
pressure to the top of the thumbscrew while turning.

• Verify that the Debrider Attachment is securely fitted to the debrider by

applying a side-to-side force to the Debrider Attachment. If the Debrider
Attachment is loose, tighten the thumbscrew. The Debrider Attachment must
not be loose or be able to move.

• Snap the receiver onto the top platform of the Debrider Attachment, similar

to attaching the Receiver to the Docking Station of an aspirator. The
InstaTrak 3500 Plus will automatically detect that the debrider is attached to
a receiver.

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OPERATING ROOM

Stryker® Hummer 2 and Hummer TPS debriders:

Figure 4-38. Debrider Attachment to the Stryker Hummer 2 Debrider

Note: In order to attach the debrider attachment to the Hummer TPS debrider the debrider

must be modified. The front collar of the Hummer TPS must be replaced with a new
front collar similar to another Stryker debrider. If the debrider has not been modified,
contact GE Medical Systems Navigation and Visualization for additional information.

• Unscrew the knob on the Debrider Attachment to open the clamp. It is not

necessary to completely remove the knob from the clamp.

• Attach the Debrider Attachment to the Hummer 2 or Hummer TPS Debrider

by placing the clamp around the midsection of the debrider. The word, Blade,
on the Debrider Attachment must face the cutter blade. Position the Debrider
Attachment at a comfortable angle on the debrider. The recommended
position is thirty degrees (30º) off center of the suction tubing to ensure that
the on/off switch can be easily accessed during the procedure.

• Align the knob with the mating threads on the clamp. Turn the knob

clockwise to tighten.

• Verify that the Debrider Attachment is securely fitted to the debrider by

applying a side-to-side force to the Debrider Attachment. If the Debrider
Attachment is loose, tighten the thumbscrew. The Debrider Attachment must
not be loose or be able to move.

• Snap the Receiver onto the top platform of the Debrider Attachment, similar

to attaching the receiver to the Docking Station of an aspirator. The
InstaTrak 3500 Plus will automatically detect that the debrider is attached to
a receiver.

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OPERATING ROOM

Linvatec E9000™ High Speed Shaver Handpiece

Figure 4-39. Debrider Attachment to Linvatec High Speed Shaver Handpiece

• Unscrew the knob on the Debrider Attachment to open the clamp. It is not

necessary to completely remove the knob from the clamp.

• Attach the Debrider Attachment to the E9000 High Speed Shaver Handpiece

by placing the clamp around the midsection of the debrider. The word, Blade,
on the Debrider Attachment must face the cutter blade. Position the Debrider
Attachment at a comfortable angle on the debrider. The recommended
position is 30º off center of the suction tube to ensure the on/off switch can
be used during the procedure.

• Align the knob with the mating threads on the clamp. Turn the knob

clockwise to tighten.

• Verify that the Debrider Attachment is securely fitted to the debrider by

applying a side-to-side force to the Debrider Attachment. If the Debrider
Attachment is loose, tighten the thumbscrew. The Debrider Attachment must
not be loose or be able to move.

• Snap the InstaTrak Receiver onto the top platform of the Debrider

Attachment, similar to attaching the receiver to the Docking Station of an
aspirator. The InstaTrak 3500 Plus will automatically detect that the
debrider is attached to a receiver.

Page 4-48

Calibration

Calibrating Instruments

Calibration is the process that identifies the position of the tip of the instrument. Every
instrument must be calibrated before using it for surgical navigation. The Calibrate
button on the VISUALIZATION MENU remains orange until calibration is completed
and then changes to green.

CAUTION

If a non-sterile pointer was calibrated for registration, the sterile pointer should
also be calibrated even if the Calibrate button remains green. This action
ensures the best accuracy.

To calibrate an instrument:

 Place the tip of the instrument in the dimple on the transmitter.

OPERATING ROOM

3

2

1

Figure 4-40. Calibration

• Select the Calibrate button from the VISUALIZATION MENU.

• If calibration is successful on one point, the Calibrate button turns green.

• If the following message appears, keep the instrument in the dimple

4

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OPERATING ROOM

• Slightly rotate or move the instrument through three (3) additional points. A bell

sounds and the cursor moves down the dialog box as each point is accepted.

• When all points are accepted, the Calibrate button turns green.

Figure 4-41. 4 Point Calibration Dialog

Note: In order to pass calibration, the instrument tip must be in the transmitter dimple when a

point is collected. If desired, place a finger on the instrument tip to ensure that it is held
in the dimple.

CAUTION

If a non-sterile pointer was calibrated for registration, the sterile pointer should
also be calibrated even if the Calibrate button remains green. This action
ensures the greatest accuracy.

Calibrating on Transmitter Dimple

• Turn the dissector to its normal “right-side-up” position

• Place the tip of the dissector into the dimple on the Transmitter, with the

dissector held “right-side-up” and at a slight angle, as shown in Figure 4-42.

• Collect 4 points by rotating the Receiver to 9:00, 11:00, 1:00, and 3:00 positions.

• The Receiver cable must not touch the Transmitter during Calibration.

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OPERATING ROOM

Figure 4-42. Calibrating the Gyrus Diego Powered Dissector

Note: The receiver cable must not touch the transmitter during Calibration.
Note: Calibration for Diego Powered Dissector is similar to the calibration procedure for the

Aspirator, but the four points should be collected in 60° intervals in two (upper)
quadrants (between 9:00 to 3:00).

.

Figure 4-43. Suggested Calibration Points

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OPERATING ROOM

Stryker Hummer and TPS Debriders

A sterile Calibration Post must be used to calibrate the Stryker debriders when attached to
the debrider attachment. Cut a small hole in the Headset draping and insert the sterile
Calibration Post into the hole in the transmitter. Turn the sterile Calibration Post slightly
to lock into place.

Using the dimple on the sterile Calibration Post, follow the instructions for calibration.

Note: In order to calibrate the debrider attachment on the Stryker debrider, the sterile

Calibration Post must be attached to the transmitter.

Page 4-52

Registration

Registration is the process of aligning the scan to the patient’s physical space. This
process enables surgical navigation to be performed accurately.

For more details about registration, refer to Getting Started in this manual and to System
Operation in the InstaTrak 3500 Plus Operator’s Manual.

There are three methods of registration that may be used with the Advanced ENT
Application:

• AccuMatch™ Surface Registration

• Fiducial Registration

• Automatic Headset Registration

You must access the REGISTRATION MENU to perform either an AccuMatch™
surface registration or a fiducial registration.

You don’t have to use the REGISTRATION MENU if you are using the Headset with
automatic registration.

OPERATING ROOM

Automatic Registration Headset

The Automatic Registration Headset can be used for procedures where access to patient
anatomy will not be obstructed by use of the device. Registration, the alignment of the
images and the patient’s anatomy, is done automatically with the Headset. Automatic
registration and Auto Plus registration may only be obtained through use of the Headset
at the time of the scan and in the OR. When AccuMatch™ registration is preferred, the
Headset may function simply as a transmitter attachment device.

Auto Plus Registration

Auto Plus registration requires that the patient wear the Headset with Lateral Markers
during the CT scan and during surgery. Both of the Lateral Markers must be visible on
the CT scan and automatic registration must be listed in the Auto Reg column as Yes.

Lateral Markers Lateral Markers

Figure 4-44 Lateral Marker Position

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OPERATING ROOM

After calibrating and verifying the instrument, an orange message box may appear,
indicating that the lateral markers have been identified by the System.

Figure 4-45 Lateral Marker Message

Collecting Lateral Markers

To collect the lateral markers on the Headset:

• Touch the tip of the instrument to one of the lateral markers on the side of the

Headset. A bell sounds when the point is collected.

• Touch the other marker. A bell sounds when the point is collected.

If the RMS is less than three (3) mm, the VISUALIZATION MENU is displayed and
tracking is initiated. If the RMS is greater than three (3) mm, registration is unacceptable
and a yellow dialog appears with the option to recollect the markers.

To continue without using the lateral markers, select the Cancel button and return to
Automatic Registration.

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OPERATING ROOM

Performing a Fiducial or AccuMatch™
Registration

To perform a fiducial or AccuMatch™ registration you must first calibrate the non-sterile
registration pointer. After calibrating, select the Registration button. The
REGISTRATION MENU appears with Automatic, Fiducial, or AccuMatch selected as
the method of registration.

Figure 4-46. Use the Registration Button to Select Method

To change the method of registration, select the Registration Method button. A pull­down menu appears.

Figure 4-47. Registration Method Pull Down Menu

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OPERATING ROOM

Select AccuMatch™ or Fiducial, as applicable.

Fiducial Registration

A fiducial registration requires that fiducial markers be placed on the patient prior to the
scan. The fiducial markers contain a radio-opaque material that shows up on the medical
image. These fiducial markers must remain on the patient until the registration process
has been completed.

Fast Fiducial Registration is an exclusive GE Healthcare feature where the system
software automatically locates the markers on the scan, eliminating the process of
identifying the markers manually as in a standard fiducial registration.

The InstaTrak® 3500 Plus stores the location of each fiducial marker that is
automatically identified on the medical image. The actual physical marker on the patient
must be touched with the instrument tip in order to “collect” the point for a valid
registration. The system then calculates the registration RMS value.

CAUTION

Fast Fiducial Registration is not compatible with T2 weighted MR scans because
fiducial markers do not show up clearly on the images.

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OPERATING ROOM

Fiducial Registration Instructions

Use the following procedure for both the standard fiducial registration and fast fiducial
registration methods. The term fiducial applies to the donut type of fiducial marker
placed on the patient before the scan.

Note: Before proceeding, rotate the 3-D model so that the majority of the fiducials are visible.

1. After the instrument has been calibrated, select the Registration button. If

necessary, select Fiducial as the registration method.

2. If the system has identified the fiducial markers on the scan, the Collect

Fiducials message appears automatically, and a Fast Fiducial Registration may

be performed.

Fiducial

Fiducial

Registration

Registration

Selected

Selected

Registration

Registration

Points

Points

List

List

Figure 4-48. Fast Fiducial Registration Display

3. A red arrow points to the first fiducial marker on the 3-D model. The crosshairs

are centered on the fiducial and the Registration Points List shows all fiducials

that were located as Uncollected. In this case, skip to Step 13 to continue the

registration process.

4. If the Collect Fiducials message does not appear, and Number One (1) on the

Registration Points List is <Insertion Point>, the system was unable to perform

a valid registration. The Fast Fiducial Registration is not active and a standard

fiducial registration must be performed. In this case, follow all instructions to

complete the fiducial registration process or to add fiducials to the Registration

Points List.

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5. Scroll through the patient’s images and 3D model to identify a fiducial marker.

Crosshairs

Centered

on Fiducial

Markers

Crosshairs

Centered

On Fiducial

Markers

Crosshairs Centered
On Fiducial Markers
on 3D Model

Figure 4-49. Identifying Fiducial Markers with 4:1 Magnification

6. Place the crosshairs in the center of the first fiducial location on the images.

Alignment can be checked in all three planes axial, coronal and sagittal or on the
3D model. Adjust the crosshair position until the center of the crosshairs appears
in the center of the fiducial marker on each one of the orthogonal images.

Note: Select 4:1 magnification for a more precise selection during this step.
Note: As points are collected, the System automatically highlights the applicable “insertion

point” on the list. If an insertion point is reselected manually, the automatic process is
inactive and the cursor must be moved manually from that point on.

7. Select the Image Point button. The Insertion Point List now states:

a. Uncollected
b. <insertion point>

8. Locate the second fiducial marker and center the crosshairs.

9. Select the Image Point button. The Insertion Point List now states:

a. Uncollected
b. Uncollected
c. <insertion point>

10. Continue this process until all fiducials seen on the scan are listed in the

Insertion Point List as Uncollected.

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11. Select the Begin Rec. Acquis. (Begin Receiver Acquisition) button. The Collect

Fiducials message appears and a red arrow points to the fiducial marker on the

3D Model.

12. Fast Fiducial Registration instructions resume at this point.

CAUTION

If more than seven (7) fiducial markers were placed and are identified by the
System, you must collect them in the order indicated by the position of the Red
Arrow on the Display. If seven (7) or less fiducial markers were identified by the
System, and no markers were skipped, you may collect the fiducial markers in
any order.

13. Gently place the pointer in the center of the first fiducial on the patient. Be

careful not to depress the surface of the skin.

a. A high-pitched bell sound indicates that the point was successfully collected.
b. A lower-pitch tone indicates that the system was unable to collect the point.

If there is motion of the instrument or excessive metal interference during a point
collection, the following messages appear and the point is not collected. Select OK to
remove the message.

The point may be recollected. Place the instrument tip on the center of the fiducial
marker, but reposition the receiver in order to reduce metal interference. Select the
Collect Receiver Pts. button.

14. Continue this process until all the fiducials are listed in the Insertion Point List

as collected. Ensure that points are collected only once.

WARNING

It is important that a point is collected only once. Collecting the same point twice
may cause system inaccuracies that could lead to a potential patient safety
hazard.

15. The system calculates the best fit of the image point positions and the actual

patient locations. This value can be seen in the Registration RMS. If the

Registration RMS is acceptable, RMS < 3 mm, you will automatically proceed to

the Visualization Menu to continue with the procedure.

16. If the registration is unacceptable, RMS > 3mm, the following dialog appears:

Figure 4-50. Field Interference Messages

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Figure 4-51. Registration Unacceptable Message

a. Select Yes to recollect the receiver points by touching the center of the

fiducial marker with the tip of the instrument.

b. To repeat the entire process, select the Reset Receiver Pts button to return all

of the image points to Uncollected.

c. If No is selected, the Registration RMS appears on the menu and a residual

distance in millimeters is listed for each insertion point. If one or more of the
values is significantly higher than the other points, and there are enough
fiducials listed (four [4] are required for a valid registration), entries may be
deleted. To delete points, select the entry, and then select Delete Single
Entry. The system recalculates the Registration RMS.

Figure 4-52. Registration Unacceptable - Retry Message

17. In rare instances the selected points cannot determine a registration because the

information is mathematically indeterminate. This occurs if the points are too
close together or are positioned in a straight line. If at least four (4) registration
points cannot be collected, a valid registration may not be possible.

18. When the registration process is complete, select the Visualization button to

return to the VISUALIZATION MENU and continue with the procedure.

AccuMatch™ Surface Registration

AccuMatch™ Surface Registration is an optional feature. If your system is equipped, the
REGISTRATION MENU will list AccuMatch as one of the available methods of
registration. If your system is not equipped, the REGISTRATION MENU will list
AccuMatch, but the button will be disabled.

If the patient was not scanned with fiducial markers or the headset, the AccuMatch
registration may be used as an alternate registration process.

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A Button Probe is used to perform an AccuMatch registration. Before beginning the
registration process, the Button Probe must be calibrated and the transmitter must be
securely attached to the patient using either the headset or one of the transmitter
attachment arms.

Guidelines for AccuMatch Registration

• Scan must include anatomical landmarks (nose and ears).

• Collect points in areas where bone is in close proximity to the skin surface

and where the skin is relatively immobile.

• Do not collect points on surface areas of trauma, loose skin (cheeks, previous

craniotomy sites) or movable parts (mandible).

CAUTION

AccuMatch™ Surface Registration is highly dependent on user technique, which
may result in System accuracy variations.

To perform an AccuMatch Registration:

1. After the button probe has been calibrated, select the Registration button. The

REGISTRATION MENU appears.

2. If the Collect/Cancel message appears, select Cancel

3. Select AccuMatch from the pull-down Registration menu.

4. The AccuMatch SURFACE REGISTRATION MENU appears with the 3-D

model displayed on the full screen.

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AccuMatch
Registration
Selected

Find, Touch,
Paint Buttons

Figure 4-53 . AccuMatch Registration Menu

AccuMatch Registration process consists of three (3) steps:

1. Find - Three (3) points are placed on the 3D model using the mouse.

2. Touch - The corresponding three (3) points are touched on the patient.

Note: An RMS number appears after the Touch process is complete. The RMS reflects the

correlation of the three points as set on the 3D model and touched on the patient. If this
RMS is greater than fifteen (15), a message appears indicating that the registration
process must be repeated.

3. Paint - A series of lines are “painted” on the surface of the patient’s skin.

Note: A new RMS replaces the previous RMS in the upper left corner of the screen. The new

RMS reflects the correlation of the patient’s scan with the AccuMatch Registration point
collection.

Step #1 - Find

• Select the Find button.

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• Using the mouse, find three (3) points on the 3D Model. These three (3)

points should surround the area of surgical interest and be as widely
dispersed as possible while still on a single rigid anatomical structure.