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NL4000 BODYTOM USER MANUAL

1-NL4000-060 REVISION 02

BodyTom is a registered trademark of NeuroLogica Corporation

Table of Contents
Contents
Table of Contents .................................................................................. 2
Contents .......................................................................................... 2
Figures............................................................................................. 5
Tables ............................................................................................. 8
Contact Information ............................................................................... 9
DAMAGE IN TRANSPORTATION .................................................................... 9
Chapter 1 - Getting Started ..................................................................... 10
1.
Intended Use ............................................................................. 10
2.
Personnel Privileges & Terminology: ................................................. 10
3.
NL4000 BodyTom Typical Configuration ............................................ 11
4.
Use of Manual ............................................................................ 11
5.
Safety Classification Symbols and System Help .................................... 11
6.
System Equipment Safety Warning Designations ................................... 12
7.
Cautionary Information ................................................................. 12
8.
NeuroLogica Contact Help ............................................................. 14
Chapter 2 - The Workstation Getting Started ................................................ 15
1.
Location of the Workstation ........................................................... 15
2.
Logging In and Out of the Workstation .............................................. 16
3.
Shutting Down the Workstation ....................................................... 16
4.
Main Menu ................................................................................ 17
5.
About The Workstation ................................................................. 19
6.
General Scanner Operation Information ............................................. 19
Chapter 3 - Workstation Configuration and Setup ........................................... 21
1.
The Basics ................................................................................ 21
2.
Focal Spot ................................................................................ 21
3.
Source to Detector Distance (SID) .................................................... 21
4.
Anode Input Power ...................................................................... 21
5.
Protocol Manager ........................................................................ 22
6.
Load Factors ............................................................................. 22
7.
Add New / Update Protocol ........................................................... 23
8.
Delete a Protocol ........................................................................ 28
9.
Change Protocol Order ................................................................. 28
10. Import Protocols ......................................................................... 28
11. Export Protocols ......................................................................... 29
12. Customize Menu Bar .................................................................... 29
13. General Settings ......................................................................... 30
14. User Accounts ............................................................................ 31
15. Manage Users ............................................................................ 31
16. Save User ................................................................................. 31
17. Update User .............................................................................. 32
18. Delete User ............................................................................... 32
19. Modify User Order ....................................................................... 32
20. Unlock User .............................................................................. 32
21. DICOM Servers ........................................................................... 32
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22. Manage Servers .......................................................................... 33


23. Save a Server............................................................................. 33
24. Update a Server ......................................................................... 34
25. Delete a Server .......................................................................... 34
26. Echo Server ............................................................................... 34
27. Modify Server Order..................................................................... 34
28. DICOM Settings........................................................................... 35
29. Dose Configuration ...................................................................... 35
30. Windowing Presets ...................................................................... 37
31. Update Account ......................................................................... 37
32. Column Settings ......................................................................... 37
33. Scan Dosage Report ..................................................................... 38
Chapter 4 - Scanning Basics ..................................................................... 39
1.
Contraindication(s) ..................................................................... 39
2.
Physical Setup, Patient, and Scanner Positioning .................................. 39
3.
Patient Support/Bed .................................................................... 40
4.
Pendant Control ......................................................................... 41
5.
Scanning .................................................................................. 44
Chapter 5 - Workstation Scanning .............................................................. 48
1.
The Basics ................................................................................ 48
2.
Patient Registration..................................................................... 48
3.
Perform Query Steps .................................................................... 50
4.
Create a Stored List ..................................................................... 50
5.
Delete a Stored Procedure ............................................................. 50
6.
Manually Register a Patient ........................................................... 50
7.
Acquisition................................................................................ 51
8.
Perform Acquisition Steps ............................................................. 55
9.
Perform a Reference Scan ............................................................. 58
10. Screen Setup ............................................................................. 58
11. Post Reconstruction ..................................................................... 61
12. Perform Post Reconstruction Steps................................................... 63
13. Finalize Exam ............................................................................ 63
Chapter 6 Patient Browser and Viewing ..................................................... 64
1.
The Basics ................................................................................ 64
2.
Patient Browser ......................................................................... 64
3.
Archive to PACS.......................................................................... 68
4.
Print ....................................................................................... 69
5.
Delete Series ............................................................................. 69
6.
Lock Series ............................................................................... 70
7.
Mark Series ............................................................................... 70
8.
Merge Series.............................................................................. 70
9.
Register Patient ......................................................................... 71
10. Load Series into Viewing ............................................................... 71
11. View/Update Series ..................................................................... 71
12. Modify Series Scanned Under Wrong Patient ....................................... 72
13. View/Update QA Series ................................................................ 73
14. Import Series ............................................................................. 73
15. Viewing ................................................................................... 74
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16. Save Preset ............................................................................... 79


17. Delete Preset ............................................................................ 80
18. Change Layout ........................................................................... 80
Chapter 7 - Compliance Requirements ........................................................ 81
1.
Group 1 Class A Medical Devices ...................................................... 81
2.
Compliance Statement ................................................................. 82
3.
EMI/EMC Glossary Terms ............................................................... 82
4.
Countermeasures against EMC related issues ....................................... 86
5.
Use Recommendations ................................................................. 88
6.
Installation Recommendations ........................................................ 88
Chapter 8 - Core Safety Guidelines............................................................. 90
1.
General Safety Considerations and Statements .................................... 90
2.
Cleaning the unit ........................................................................ 91
3.
Maintenance and Service............................................................... 92
4.
Calibration ............................................................................... 92
5.
Battery Safety and Information ....................................................... 93
6.
Emergency Stop ......................................................................... 94
7.
Electrical Safety ......................................................................... 94
8.
Radiation Safety ......................................................................... 96
9.
Mechanical Safety ....................................................................... 97
10. Laser Safety .............................................................................. 98
11. Gantry Mobility Safety ................................................................ 100
12. Considerations when preparing the gantry for use .............................. 100
Chapter 9 - System Classification and Symbols ............................................. 102
1.
IEC Classification ...................................................................... 102
Chapter 10 - Technical Specifications ....................................................... 105
1.
Environmental Specifications ....................................................... 105
2.
Part Numbers and Marking Plates .................................................. 106
Chapter 11 Quality Assurance & Imaging ................................................... 107
1.
Image Quality Basics .................................................................. 107
2.
QA Phantom ............................................................................ 107
3.
Quality Assurance Tool ............................................................... 110
4.
Dose ..................................................................................... 117
5.
Dose in Air .............................................................................. 119
6.
Measurement Accuracies ............................................................. 120
7.
Scatter Radiation ...................................................................... 121
8.
Dose Profile ............................................................................ 127
Chapter 12 System Storage, Powering On & Transporting .............................. 128
1.
Storage .................................................................................. 128
2.
Transport ............................................................................... 128
3.
Bumper System: ....................................................................... 130
Appendix A ....................................................................................... 131
1.
Tool Quick Reference Guide ......................................................... 131
Appendix B Error Codes....................................................................... 140
Revision History.................................................................................. 148

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Figures
Figure 1: System Label & Location (2 pictures) .............................................. 14
Figure 2: WorkStation Safe Distance Location (2 views) .................................... 15
Figure 3: WorkStation Login Window ........................................................... 16
Figure 4: Main Menu Tool Bar ................................................................... 17
Figure 5: File Pull Down Menu ................................................................ 17
Figure 6: Tools Pull Down Menu .............................................................. 17
Figure 7: Customize Pull Down Menu ........................................................ 17
Figure 8: Help Pull Down Menu ............................................................... 18
Figure 9: Online User Manual (Screen Shot) .................................................. 18
Figure 10: Remote Support (Screen Shot) ..................................................... 18
Figure 11: About Us (Screen Shot) ........................................................... 19
Figure 12: Lock Icon .............................................................................. 19
Figure 13: Daily Cal ............................................................................... 20
Figure 14: Protocol Manager..................................................................... 22
Figure 15: Protocol Manager Button Details .................................................. 23
Figure 16: Tools Pull Down Menu ............................................................ 24
Figure 17: Adult or Pediatric selection screen .............................................. 24
Figure 18: Protocol Information Screen ....................................................... 24
Figure 19: Protocol Information Screen (Close-up) .......................................... 25
Figure 20: Patient Position Screen ............................................................. 25
Figure 21: Protocol Series Screen............................................................... 26
Figure 22: New Reconstruction Window (Close-up).......................................... 28
Figure 23: System User Icon ..................................................................... 29
Figure 24: Menu Bar Buttons (Customization) ................................................ 30
Figure 25: General Setting Window ............................................................ 30
Figure 26: User Account Window ............................................................... 31
Figure 27: Servers Window....................................................................... 32
Figure 28: PACS List Window .................................................................... 33
Figure 29: Options Window ...................................................................... 33
Figure 30: DICOM Settings Window ............................................................. 35
Figure 31: DICOM Settings Tool Bar ............................................................ 35
Figure 32: Dose Check Window ................................................................. 35
Figure 33: Dose Configuration Window ........................................................ 36
Figure 34: Dose Configuration Window ........................................................ 37
Figure 35: Update Account Window ............................................................ 37
Figure 36: Column Settings Window (View 1) ................................................. 37
Figure 37: Update Account Window (View 2) ................................................. 38
Figure 38: Scan Dose Report Window .......................................................... 38
Figure 39: Patient Position Prep (BodyTom Front View) .................................... 39
Figure 40: Workstation ........................................................................... 40
Figure 41: WorkStation Login Window ......................................................... 40
Figure 42: Control Panel showing Ethernet Cable Connected.............................. 40
Figure 43: Patient in bore (Height Positioning) .............................................. 41
Figure 44: Pendant Remote ...................................................................... 42
Figure 45: Pendant Remote Buttons ........................................................... 42
Figure 46: Pendant use for positioning lasers upon patient ................................ 43
Figure 47: Patient Registration Icon ........................................................... 44
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Figure 48: Protocol Selection Window ......................................................... 44


Figure 49: Begin Icon ............................................................................. 44
Figure 50: Scanner Position Window Zero Reference ...................................... 44
Figure 51: System Ready to Scan Window ..................................................... 45
Figure 52: Operator Control Panel ............................................................. 45
Figure 53: Countdown Window .................................................................. 46
Figure 54: Workstation Screen .................................................................. 47
Figure 55: Scanner Removal Prep (BodyTom Front View) .................................. 47
Figure 56: Workstation Tabs ..................................................................... 48
Figure 57: Patient Registration Window ....................................................... 48
Figure 58: Patient Registration Buttons ....................................................... 49
Figure 59: Query Information Window (Patient Registration) .............................. 50
Figure 60: Acquisition Screen ................................................................... 51
Figure 61: Acquisition Buttons .................................................................. 52
Figure 62: Patient Exam Details (Acquisition Screen ~ Close-up) ......................... 52
Figure 63: Current Scan Details (Acquisition Screen ~ Close-up) .......................... 53
Figure 64: Patient Position Screen ............................................................. 53
Figure 65: Viewing Tools (Acquisition Screen ~ Close-up) .................................. 54
Figure 66: Viewing Tools Buttons ............................................................... 55
Figure 67: Windowing (Acquisition Screen ~ Close-up)...................................... 55
Figure 68: Zoom (Acquisition Screen ~ Close-up) ............................................ 55
Figure 69: Protocol Selection Window ......................................................... 56
Figure 70: Protocol Information Screen ....................................................... 56
Figure 71: System Ready to Scan Window ..................................................... 57
Figure 72: System Ready to Scan Window ..................................................... 57
Figure 73: Workstation/Scanner Status Bar ................................................... 58
Figure 74: Workstation/Scanner Status Details by Icon ..................................... 60
Figure 75: Post Reconstruction Screen ........................................................ 61
Figure 76: Reconstruction Parameters (Post Reconstruction Screen ~ Close-up) ....... 61
Figure 77: Post Reconstruction Buttons ....................................................... 62
Figure 78: Workstation Tabs ..................................................................... 64
Figure 79: Patient Browser ...................................................................... 64
Figure 80: Patient Browser Buttons ............................................................ 65
Figure 81: Examination Table (PT Browser ~ Close-up) ..................................... 65
Figure 82: Series Table (PT Browser ~ Close-up) ............................................. 66
Figure 83: Series Protocol Table (PT Browser ~ Close-up) .................................. 66
Figure 84: Series Image Table (PT Browser ~ Close-up)..................................... 66
Figure 85: Image Preview Screen (PT Browser ~ Close-up) ................................. 66
Figure 86: Store/Print Queue Screen .......................................................... 67
Figure 87: Store/Print Queue Buttons ......................................................... 67
Figure 88: Archive Destination Window........................................................ 68
Figure 89: Archive to server Window .......................................................... 68
Figure 90: Tools Pull Down Menu ............................................................ 68
Figure 91: Merge Window ........................................................................ 70
Figure 92: View/Update Pop-up Window ...................................................... 71
Figure 93: View/Update Button (View/Update Info Window) .............................. 72
Figure 94: View/Update Pop-up Window ...................................................... 72
Figure 95: Move Button (View/Update Info Window)........................................ 72
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Figure 96: Move Series Window ................................................................. 72


Figure 97: Import Button (PT Browser) ........................................................ 73
Figure 98: Import Location Window ............................................................ 73
Figure 99: Import Button (PT Browser) ........................................................ 74
Figure 100: Minimize Button (PT Browser) .................................................... 74
Figure 101: Cancel Button (Import Location Window) ...................................... 74
Figure 102: 2D View Screen...................................................................... 74
Figure 103: MPR View Screen .................................................................... 75
Figure 104: 3D View Screen...................................................................... 75
Figure 105: 3D Tools Screen (Left) ............................................................. 75
Figure 106: MPR Tools Screen (Center) ........................................................ 75
Figure 107: 2D Tools Screen (Right) ............................................................ 75
Figure 108: View Screens Tool Buttons ........................................................ 77
Figure 109: Windowing (View Screens Tools ~ Close-up) ................................... 77
Figure 110: Layout (View Screens Tools ~ Close-up) ........................................ 77
Figure 111: Zoom (View Screens Tools ~ Close-up) .......................................... 77
Figure 112: Rotate (View Screens Tools ~ Close-up) ........................................ 78
Figure 113: Positioning (View Screens Tools ~ Close-up) ................................... 78
Figure 114: Positioning Buttons (View Screens Tools ~ Close-up) ......................... 78
Figure 115: Compare (View Screens Tools ~ Close-up) ...................................... 79
Figure 116: Positioning (3D View Screen Tools ~ Close-up) ................................ 79
Figure 117: Rendering (3D View Screen Tools ~ Close-up) ................................. 79
Figure 118: Orientation (3D View Screen Tools ~ Close-up) ................................ 79
Figure 119: Laser Apertures Direction ........................................................ 99
Figure 120: Radial MTF ......................................................................... 108
Figure 121: Tangential MTF .................................................................... 109
Figure 122: Tools Pull Down Menu ......................................................... 110
Figure 123: Phantom Holder ................................................................... 111
Figure 124: Phantom Positioning ............................................................. 111
Figure 125: Exam Planner Window ........................................................... 112
Figure 126: Edit Protocol Window ............................................................ 112
Figure 127: Edit Series Window ............................................................... 113
Figure 128: Reconstruction Window .......................................................... 114
Figure 129: Noise and Uniformity ............................................................. 115
Figure 130: CT Values and Low Contrast .................................................... 115
Figure 131: Center Value Window ............................................................ 116
Figure 132: Center Value Window (Adjusted Image) ...................................... 116
Figure 133: Center Value Window (Slice Thickness Result) .............................. 117
Figure 134: Scatter Plot (120kV, 100mA in Rad) .......................................... 122
Figure 135: Scatter Plot (120kV, 100mA in Gy) ........................................... 123
Figure 136: Scatter Plot (140kV, 300mA in Rad) .......................................... 123
Figure 137: Scatter Plot (140kV, 300mA in Gy) ........................................... 124
Figure 138: Scatter Measurements (x-y plane) ............................................. 125
Figure 139: Scatter Measurements (y-z plane) ............................................. 126
Figure 140: Dose Profile for 8 Rows .......................................................... 127
Figure 141: Dose Profile for 32 Rows ......................................................... 127
Figure 142: Control Panel Buttons and Details ............................................. 128
Figure 143: Common Workstation Buttons .................................................. 135
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Figure 144: Common Workstation Tools ..................................................... 139

Tables
Table 1: Contact Information ................................................................... 14
Table 2: Load Factor Table ...................................................................... 22
Table 3: Emission Declaration for NL4000 BodyTom systems ............................. 83
Table 4: EMC Immunity Declaration For NL4000 BodyTom systems ...................... 84
Table 5: EMC Immunity Declaration ............................................................ 86
Table 6: EMC Recommended Separation Distances .......................................... 87
Table 7: Applicable IEC Symbols .............................................................. 102
Table 8: Specified Environment............................................................... 105
Table 9: System Operating Parameters & Specifications ................................. 105
Table 10: Battery Operating Parameters .................................................... 106
Table 11: Hazardous Substances Table ...................................................... 106
Table 12: Filtration Table...................................................................... 106
Table 13: Core System Component Part Number Information ........................... 106
Table 14: Core System Component Dimensions ............................................ 106
Table 15: Modulation Transfer Function (MTF) ............................................. 108
Table 16: QA Results Table .................................................................... 109
Table 17: ROI Properties/Locations .......................................................... 115
Table 18: Body CTDIw (mGy/100mAs) ........................................................ 118
Table 19: Head CTDIw (mGy/100mAs)........................................................ 119
Table 20: The normalized CTDI of the body phantom. .................................... 119
Table 21: The normalized head CTDI. ....................................................... 119
Table 22: CTDIAIR (mGy/100mAs) ............................................................. 119
Table 23: Mean and Standard Deviation of the CTDI air) ................................. 119
Table 24: Tube Accuracy ....................................................................... 120
Table 25: Scatter Measurements (x-y plane) (Rad/100 mAs) ........................... 125
Table 26: Scatter Measurements (y-z plane) (Rad/100 mAs) ........................... 126
Table 27: Error Codes .......................................................................... 140
Table 28: Revision History Table ............................................................. 148

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Contact Information
To provide any comments, suggestions or corrections to this document, please write
(include the chapter title and page number) and send them to:
NeuroLogica Corporation
14 Electronics Avenue
Danvers, Ma, 01923
U.S.A.
This document is the original English version

DAMAGE IN TRANSPORTATION
All packages should be closely examined at time of delivery. If damage is
apparent, have the notation damage in shipment written on all copies of
the freight bill before delivery is accepted or signed for by the hospital
receiving agent.
Whether damage is noted immediately or concealed (noticed after delivery),
the damage MUST be reported to the carrier immediately upon discovery, or
within 14 days after receipt, and the content and containers held for
inspection by the carrier.
The Transportation Company will not pay a claim for damage if an inspection
is not requested within 14 days period.

Australian Sponsor

EU Rep
Winckels Medical Devices Expertise
Europe Bergerweg 18
6085 AT Horn
Holland

LifeHealthCare
15 Talavera Road
North Ryde NSW 2113 Australia
Attn: Daren McKennay
+61 (0) 2 8114 1503
dmckennay@lifehealthcare.com.au

+31 (0)475 582285 Tel


+31 (0)475 582278 Fax
+31 (0)6 532 530 76 Mobile
http://www.wmdegroup.com

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Chapter 1 - Getting Started


This chapter is an overview of the system, including descriptions of the core system
components, safety classifications, symbols, and system help

1. Intended Use

The NL4000 BodyTom CT scanner is intended to be used for X-ray computed


tomography applications for anatomy that can be imaged in the 60cm field of view.

2. Personnel Privileges & Terminology:


1. Qualified Operator:
The operators (e.g. technologists, radiologists, etc.) as determined by the healthcare
facility and assigned via a user with administrative privileges, who by his/her
education, certification, experience, and training are sufficiently qualified to
competently perform clinical scans on the particular model of CT system which they
are to use.
2. Operator of Record:
This person is the operator or health care professional that is currently logged onto
the CT system via a unique identifier.
3. Scanning Privileges:
Scanning privileges are granted to a qualified operator who has been assigned by a
user with administrative privileges to conduct clinical scans on the particular model of
CT system which they are to use. This level of privilege allows use of all clinical
protocols on the system including necessary adjustments to the scan parameters at
scan time to properly scan the given patient.
4. Protocol Privileges:
Protocol privileges are granted to a qualified healthcare professional (e.g. radiologist,
technologist, physicist) as determined by the healthcare facility and assigned via a
user with administrative privileges who by his/her education, certification,
experience, and training is sufficiently qualified to competently save clinical
protocols (either new or modified) on the particular model of CT system which they
working on. A healthcare professional with protocol privileges does not necessarily
have to have scanning privileges on the particular CT system.
5. Administrative Privileges:
Administrative privileges are granted to a qualified healthcare professional (e.g.
radiologist, technologist, physicist, department administrator, etc.) as determined by
the healthcare facility who by his/her education, certification, experience, and
training is sufficiently qualified to competently assign, maintain, and oversee the
assignments of personnel to scanning privileges and/or protocol privileges on the
particular CT system which they administer. In addition, this person is also
authorized and qualified to pull system logs associated with this standard for quality
assurance review. A healthcare professional with administrative privileges does not

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necessarily have to have scanning privileges or protocol privileges on the particular CT


system.
6. Clinical Operation
Operation of the CT system that involves scanning of live humans and/or creating or
editing protocols intended for use on live humans.
7. Clinical scan or- Clinical Scanning
Operation of the CT system that involves scanning of live humans.
8. Clinical Protocol
A protocol on the system intended for use on live humans.

3. NL4000 BodyTom Typical Configuration

The NL4000 BodyTom Core system consists of the scanner and the Workstation.

The scanner and workstation communicate via a wireless or wired


connection.
Minimum Slice Thickness: 1.25 mm, Maximum Coverage: 900 mm
The workstation is a desktop with custom software that allows the user to
use pre-defined system protocols or devise unique protocols for performing
patient studies. It also allows updating of patient information, and print and
store images. The viewing portion of the workstation allows viewing of
images in more detail and includes tools to help facilitate physician
diagnosis.

4. Use of Manual

These instructions are for use with the NeuroLogica NL4000 BodyTom Computed
Tomography System manufactured by NeuroLogica Corporation. Anyone who operates
a system should have received prior training before they attempt to scan or diagnose
patients, to include medical and X-ray education, in addition to NeuroLogica
applications training. This guide does not provide medical explanations, but it does
suggest potential applications for some of the software features. It describes
potential safety problems and how to avoid them.
Everyone that uses this equipment must read, understand, and follow all instructions,
precautions and warnings.
Keep this manual near the equipment. Its important to review the procedures and
safety precautions periodically.

5. Safety Classification Symbols and System Help

This section explains how this manual and the NL4000 BodyTom display safety
information, as well as some overall cautionary information regarding the system and
its operation. Also contact information for operational and non-operational
emergencies is located at the end of this chapter.

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6. System Equipment Safety Warning Designations


Various parts of this system equipment will have the
icon. This warning symbol
indicates that the user manual should be consulted for additional information before
performing a specific action. This icon is coupled with red text, Danger, Warning, or
Caution, throughout this manual and indicates the level of danger associated with a
specific action.

DANGER: This label identifies the most severe conditions or actions that result in a
specific hazard, which could result in death or serious personal injury, or substantial
property damage, if ignored.

WARNING: This label identifies conditions or actions that result in a specific hazard,
which may cause severe personal injury, or substantial property damage, if ignored.

CAUTION: This label applies to conditions or actions that have potential hazards,
which may cause minor injury or property damage if ignored

7. Cautionary Information
WARNING: Installation of this product will be done in accordance with the Installation
Manual (1-NL4000-059). All install processes and qualified personnel are outlined in
said document.

CAUTION: System was designed for use by individuals trained in CT system operation.
User should be familiar with sections of this manual before scanning of patients. An Index
is provided to find the appropriate section and page number of an item of interest.

CAUTION: To prevent healthcare injuries, the Scanner and Workstation should NOT be
moved by a single healthcare professional at the same time.

CAUTION: Two healthcare professionals are recommended to facilitate movement of


the scanner within the facility. One in front of the scanner to ensure there are no
obstacles and the other to drive.
Note: The scanner is provided with a camera monitoring system to help
navigate the unit while being transported within a facility.

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WARNING: Never position this mobile system in a manner that will prohibit access to
unplugging it or depressing the Emergency Stop (EMO) switch.

WARNING: Scanner should not be positioned on an incline when it is in Transport


Mode to prevent involuntary movement.

CAUTION: Improper system usage could void warranty; more importantly endanger
patients and/or the users if not followed correctly.

CAUTION: Federal law restricts the use of this device without a prescription by a
physician.

CAUTION: Ensure that there is no potential detrimental interaction of the systems


irradiation with a patients active implantable medical devices and/or body worn
active medical devices.

CAUTION: The system should be plugged in at all times when possible to optimize
product performance. Failure to do so could result in permanent battery damage,
which may require repair/replacement.

CAUTION: The system may not complete a scan when below 25% battery capacity..

CAUTION: If the system is unplugged and battery capacity is reported to be 0% then


permanent damage to the battery can occur.

CAUTION: The system can only be charged from a correctly rated wall outlet. A rating
detail is located on the product system label (lower-right backside panel - see next
figure).

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Figure 1: System Label & Location (2 pictures)

CAUTION: Radiation dose exposure to patients should not exceed 1 GY CTDI.

WARNING: No modification of this equipment is allowed.

8. NeuroLogica Contact Help


This manual, though complete and accurate, may not answer undocumented changes
or unexpected results that could occur from system anomalies.
Please keep user information readily available to contact Technical Support for
assistance and resolution.
Address the comments to:
Table 1: Contact Information
Company Name
Company Department
Address
Technical Support
E-mail Address

NeuroLogica Corporation
Customer Service
14 Electronics Avenue
Danvers, MA 01923 USA
US & Canada
1-888-564-8561
International
1-978-564-8561
support@NeuroLogica.com

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Chapter 2 - The Workstation Getting


Started
This chapter is an overview of using the workstation. Detailed information about the
workstation, as well as instructions on logging in and out of the system, getting help,
and shutting down the workstation are provided.

1. Location of the Workstation


(e.g. Dell Computer Model DCTA T3500 and Monitor Model AY511)

The product safety coverage of the specified workstation (Safety Certified to IEC
60950 standards) was evaluated and deemed acceptable for use with the NL4000
BodyTom to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national
standards.
The Work station shall be kept outside of the PATIENT ENVIRONMENT as defined by
IEC 60601-1-1. The NL4000 BodyTom is suitable for use inside the PATIENT
ENVIRONMENT.

CAUTION: Do not connect or use equipment beyond what is specified by NeuroLogica


Corporation, it may lead to a reduced level of safety of the system.
The recommended distances provided below relate only to distances specified by IEC
60601-1-1 and do not relate to specific distances required for ionizing radiation
and/or stray radiation protection for operators and bystanders. Refer to Chapter 11
within this manual for additional guidance/recommendations.

1.5m (4.92')

2.5m (8.20')

1.5m (4.92')

1.5m (4.92')

Figure 2: WorkStation Safe Distance Location (2 views)

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2. Logging In and Out of the Workstation

Figure 3: WorkStation Login Window


To gain access to the workstation application, provide the system with the user
credentials. These credentials consist of a User ID and Password.
1. The user should verify that a valid User ID and Password has been provided
prior to logging into the system. If the user has not been provided with a User
ID or Password, please see the users supervisor.
2. Entering the User ID can be done in one of two ways:
3. Select the User ID from the drop down list.
4. Enter the User ID into the drop down list field.
5. Once the User ID has been selected, please enter the User Password. The
password is case sensitive, so be sure to have Caps Lock turned OFF.
6. Once the User ID and Password have been entered, press the Login button.
7. If the User ID and/or Password are invalid, a prompt will be displayed to reenter the information.
Note: Please be aware that the user has a limited amount of guesses before
the system locks the selected account. An administrator account is required
to perform unlocking procedures. Please see Chapter 6 Patient Browser &
Viewing for more details on unlocking an account.

8. Once the User ID and Password have been verified the user will be logged into
the system.
9. After login, the user may be directed to the Patient Registration tab. Please
verify that the correct User Name is displayed at the center of the screen. If
the User Name is incorrect, contact the supervisor to verify the account.
Note: For further information on the system, please see Chapter 6 Patient
Browser & Viewing.

10. To Log out of the system, under the File menu, press the Log Off menu
item to be returned to the Login portal.

3. Shutting Down the Workstation


From the Login Portal, the user can also shut down the system. This includes powering
down the entire workstation.

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1. Once the Login Portal is displayed, press the Shutdown button located on the
bottom right hand corner of the portal.
2. The application will exit and the system will shutdown.
3. While logged into the system, the user may also choose to power down or
restart either the application or the entire workstation. This can be done by
selecting the File menu and choosing any option listed in the drop-down menu.

4. Main Menu
Figure 4: Main Menu Tool Bar
The main menu tool bar provides the user with quick access to many basic functions.
The menu bar is available on any screen, located in the top left corner.
1. File

Figure 5: File Pull Down Menu


2. Tools

Figure 6: Tools Pull Down Menu

Store/Print Queue For further information, please see Chapter 4.


Protocol Manager For further information, please see Chapter 6.
Perform Daily Cal For further information, please see Chapter 2.
Quality Assurance For further information, please see Chapter 11.

3. Customize

Figure 7: Customize Pull Down Menu

For further information, please see Chapter 6.

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4. Help

Figure 8: Help Pull Down Menu


5. User Manual
An online copy of the user manual text is available in the Help menu for reference
when users are logged into the workstation.

Figure 9: Online User Manual (Screen Shot)


6. Remote Support
Remote Support is available for questions / issues that cannot be answered using the
user manual.

Figure 10: Remote Support (Screen Shot)

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7. About

Figure 11: About Us (Screen Shot)

5. About The Workstation


Once logged into the system, the user can verify it by viewing the About window.
1. Under the Help Menu, press the About menu item.
2. The About window will be displayed.
3. The following information is available:
Version Current Software Versions for the system
Licensed To Information regarding who the product is licensed to
Station AE Title for this workstation (PACS purposes)
Licensed Packages
4. Exit by pressing the Close button located in the bottom center of the popup.

6. General Scanner Operation Information


1. System Lock to Prevent Unauthorized Use

Figure 12: Lock Icon


Keep the current work guarded while away from the computer, or lock out unwanted
users by pressing the lock icon located at the center of the workstation. To lock or
unlock the workstation, enter any user account login information.
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2. Daily Calibration

Figure 13: Daily Cal


Perform a daily calibration for the scanner by selecting the Tools main menu option,
and selecting Perform Daily Cal. Press Start on the Daily Cal Window. Perform a daily
calibration before beginning a scan if the system has not been used within the last 12
hours. Ensure that there is nothing in the bore prior starting a daily calibration.
3. Daily System Safety Check
Perform a safety check of the bumper system by placing the scanner in transport
mode. Attempt to transport the scanner while another person presses on the front
bumper. The scanner should not move forward while the bumper is pressed. Proceed
with testing each bumper while attempting to move the scanner in the direction that
the bumper is facing.
Note: If any bumper fails to stop the scanner please call technical support
and setup a service call. The scanner may still be transported in this mode,
but extra caution must be observed during transport.

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Chapter 3 - Workstation Configuration


and Setup
This chapter is an overview on configuring the NL4000 BodyTom workstation.
Detailed instructions on using the Protocol Manager, Configuration Manager and
Register Package(s) tool on the workstation are provided.
Note: Make sure the wireless enable switch is ON when creating a wireless
connection between the workstation and the scanner.

Note: Wireless connections can add lag time as compared with a hardwired
(Ethernet) configuration. When using wireless, should an unexpected delay or
disconnection (due to environmental/bandwidth interference) occur, it is
recommended to hard wire an Ethernet Cord to the scanner for continued
communication.

1. The Basics
There are several tools provided by the workstation to help configure and setup the
system and workstation:
Protocol Manager Add, Update, Delete, Import and Export Protocols.
Configuration Manage Users, Servers, Customizable displays, and Viewing
Toolboxes.
Automatic Exposure Control (AEC) This feature is not offered on this
system

2. Focal Spot
Nominal Size:
Small filament ~ 0.7 x 0.8 mm
Large filament ~ 1.2 x 1.4 mm
Size Limits:
Small filament ~ 0.7 to 1.1 mm (Width)
0.8 to 1.2 mm (Length)
Large filament ~ 1.2 to 1.7 mm (Width)
1.4 to 1.9 mm (Length)
Testing Standard for reference:
IEC 60336:2005
The focal spot position superposition is 0.50mm.
The large focal spot centering is within 1 mm of center of bolt pattern.
The maximum motion due to gravity in X, Y & Z axis is 0.1 mm.
The maximum motion from anode rotation is 0.1 mm.
The maximum motion from anode heating, in the X axis is 0.1 mm.
The maximum motion from anode heating, in the Z axis is 0.3 mm.

3. Source to Detector Distance (SID)


The SID value is approximately 1041.9mm

4. Anode Input Power


The maximum anode cooling rate is 8,750W (12,250 HU/sec).
The maximum anode heat dissipation is 3,400W (4,760 HU/sec).
The nominal anode input power is 23kW (small) and 42kW (large)
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5. Protocol Manager

Figure 14: Protocol Manager


There are several tools provided by the workstation to help configure and setup
system and workstation. The Protocol Manager allows users to create, update, delete,
import and export protocols.
Note: Administrative privileges must be available to access this area.

The Protocol Manager provides users with two patient options, either adult or
pediatric. This can be adjusted using the radio buttons located on the lower left hand
side of the screen, directly below the image.
Note: Pediatric Protocol parameters are customized to meet the users
requirements in conjunction with local and nationally recognized published
guidelines. These said protocols must be approved by the users facility
physicist before systems acceptance.

6. Load Factors
Table 2: Load Factor Table
Protocol
Description
Axial
Helical

kV

mA

80-140
80-140

50-300
50-300

Time
(seconds)
1
1 per rotation

Notes:
The nominal X-ray tube voltage is 140kV and the highest x-ray tube current
selection at this voltage is 300mA.

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The highest X-ray tube current is 300mA and the highest x-ray tube voltage
selection at this current is 140kV.
The nominal x-ray output power is 42kW when operating at an x-ray tube
voltage of 140kV and x-ray current of 300mA for 4 seconds.

Buttons
Add a new protocol from the list.

Update information on an existing protocol.

Delete a saved protocol.


Import previously exported BodyTom protocols into the
workstation.
Export protocols to a media device.

Close the Protocol Manager window.

Select either an adult or pediatric patient, and the


corresponding list of saved protocols will become available.

Move a protocol up or down the ordered list, and save order.

Figure 15: Protocol Manager Button Details

7. Add New / Update Protocol


1. To access the Protocol Manager, select Tools from the menu bar, and then
press Protocol Manager.
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Note: Administrative privileges must be available to access this area.

Figure 16: Tools Pull Down Menu


2. Select either an adult or pediatric patient. Choose a colored dot that
corresponds to the correct body part. Both the Add and Update buttons will be
enabled.

Figure 17: Adult or Pediatric selection screen


3. Press the Add button, or select a protocol from the list and press the Update
button and the New Protocol window will be displayed.

Figure 18: Protocol Information Screen

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4. Fill in the appropriate protocol information in the box provided


Protocol description
Anatomical reference

Figure 19: Protocol Information Screen (Close-up)


5. Select appropriate patient position from the drop down menu. The patient
image will change in relation to the position selected by the user.
User may choose
HFS
head first-supine
HFP
head first-prone
HFDL
head first-decubitus left
HFDR
head first-decubitus right
FFS
feet first-supine
FFP
feet first-prone
FFDL
feet first-decubitus left
FFDR
feet first-decubitus right

Figure 20: Patient Position Screen

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6. Select a protocol series. User may choose from the default list, or add/update
a protocol.

Figure 21: Protocol Series Screen

Enter desired protocol parameters:


o Scan Type:
o The scan type can selected from a drop down menu. The scan can be
axial (step and shoot), helical, and dynamic.

Note: For helical scanning, the exposed area is extended by at least a


rotation to 1 full rotation at the start and end points based on the
reconstruction algorithm.

o Scout Type:
o AP, PA and Lateral scout can be selected.
o kV (Scan Voltage):
o A scan voltage of 80, 100, 120 or 140 kV can be selected. The Highest
scan current obtainable from the x-ray tube can range from 25 to 300
mA based on the available heat capacity of the x-ray tube. At a
nominal scan voltage of 120 kV, a maximum output power of 36 kW
can be maintained by the x-ray tube for at least 4 seconds if the
current heat capacity of the tube does not exceed 80%.
o mA (Scan Current):
o The scan current can varies from 20 to 300 mA with an increment of
10. The maximum scan voltage can range from 80 to 140 kV based on
the available heat capacity of the x-ray tube. The power of the x-ray
tube of any scan combination can be computed as the product of the
scan voltage and the scan current:

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The scan time determined by the current heat capacity of the x-ray
tube.
o Slice Thickness/Spacing:
o In axial (step and shoot) mode, the slice thickness is the same as
the slice spacing. The nominal slice thicknesses are multiples of
1.25mm. In helical mode the slice spacing can be different from the
slice thickness.
o Sharpness:
o The sharpness refers to the image reconstruction kernel. The kernels
are listed below.
o Resolution:
o The resolution refers to the scan time. The resolution is only used
during axial (step and shoot) scan.
o Pitch:
o The pitch describes the scanner travel per rotation. The pitch is only
relevant in helical scan mode.
o Body Part Examined
o : Anatomical part being scanned
o Description :
o User defined study description
o Start Position (mm):
o Start position of the scan
o End Position (mm) :
o End position of the scan
o Coverage (mm) :
o Total distance of the scan
o Contrast :
o Type of contrast given
o Contrast Volume :
o Amount of contrast given
o Delay :
o Start delay time given to the user once they press start scan
o Scan Time :
o Amount of time the scan will take to complete
At this point users may also add additional reconstructions to the protocol.
From the New Series window by pressing Add or Update (this can only be done
with Axial (step and shoot), Helical, and Dynamic scans). The New
Reconstruction window will open:
o Enter desired information and press Add.
o Window will close, and changes will be added to the New Series window.

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Figure 22: New Reconstruction Window (Close-up)


7. Press the Add button. New/Updated protocol will be added to the list.

8. Delete a Protocol
1. Select the anatomical region of the protocol type to be deleted.
2. Select the protocol from the list to be deleted.
System protocols cannot be deleted. If a system protocol has been selected
the Delete button will be disabled.
3. Press Delete.
4. Protocol is removed from the list.

9. Change Protocol Order


To
1.
2.
3.
4.
5.

modify the order in which the protocols appear in the system:


Select a protocol type.
Select a protocol.
Press Up arrow button to move the protocol up the list.
Press the Down arrow button to move the protocol down the list.
Press the Save button to save the list.

10.

Import Protocols

1. Open the Protocol Manager and press the Import button. The select file window
will be displayed.
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2. Users may select the files they wish to import.


3. Press the Import button on the Select File window.
4. Protocol list will reflect the changes.

11.

Export Protocols

1. Open the Protocol Manager and press the Export button. The Select Directory
window will be displayed.
2. Users may select where they wish to export the files. Press the Select button
on the select directory window.
3. A notification should appear alerting users that files were exported
successfully.

12.

Customize Menu Bar

Figure 23: System User Icon


Buttons
Clear information fields.
Close the System or User Configuration
window.
Delete selected item.

Delete all items displayed in the list.


Echo the selected server to test the
connection.
Create a new folder.
Reset information back to default, or clear
information field.

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Save updated information.


User may use the arrow buttons to move
the selected item up or down the list. Press
Save to save the order.
Administrators may unlock a user account.

Update information.

Move selected item up or down.

Move selected item up or down.

View information.

Figure 24: Menu Bar Buttons (Customization)


Note: Administrative privileges must be available to access this area.

13.

General Settings

Figure 25: General Setting Window

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The following information may be adjusted by the user using the General Settings
window:
System Station AE Title
Scanner IP Address
Options to
Scanner Control Software port
o Automatically Show
Reconstruction Software port
Store/Print Queue
Remote Support Setup
o
Auto Store/Print
Options for Advanced 2D
o Show Dose Report
Viewing Orientation
o Show Stored Query
Change Password Interval
Results
HIS/RIS and PACS Network
o
Auto Lock
Connection
Institution Information
To apply the information and selections entered, press the Save button before closing
the window.

14. User Accounts


This tab is used to update user accounts, add new users, and unlock a user.

Figure 26: User Account Window

15. Manage Users


This tab gives access to the users saved to the system.
To access the User Accounts tab:
1. The user must be logged into an administrative account to access User
Accounts.
2. Select the Customize menu, choose System.
3. The System Configuration window will be displayed. Select the User Accounts
tab from the seven options at the top of the window.

16. Save User


1.
2.
3.
4.

Enter User ID.


Enter User Level.
Enter Last Name.
Enter First Name.

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5.
6.
7.
8.

Enter Password.
Verify Password.
Press Save.
User is added to list.

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17. Update User


1. Select a user.
2. Modify user information.

3. Press Update button.


4. User should reflect changes made.

18. Delete User


1. Select a user.
2. Press Delete button. A confirmation window will be displayed, telling user that
the action was successful.
Note: Last administrative user cannot be deleted.

19. Modify User Order


1. Select user.
2. Press Up button to move user up
the list.

3. Press Down button to move user


down the list.
4. Press Save Order to save user list
order.

20. Unlock User


1. Select user.
2. Press Unlock button.

3. User should reflect changes


made.

21. DICOM Servers


1. Servers

Figure 27: Servers Window

BodyTom is a registered trademark of NeuroLogica Corporation

2. Picture Archiving and Communication System (PACS) List

Figure 28: PACS List Window


3. Options

Figure 29: Options Window

22. Manage Servers


The System Configuration window gives access to all the servers and printers saved to
system. To access this, select customize from the menu options, then select system.
Administrative privileges to access the System Configuration window must be
available.
When the window is open, select the DICOM Servers tab. This tab is broken into three
sections:
Existing Servers List servers based on type: Store, Worklist, and Film. This
also displays server details and options, along with controls for saving,
updating, deleting, and echoing servers.
PACs List Setup a list of PACS to send to by default (Store/Print only).
Options Controls for PACS Options and HIS/RIS Options.

23. Save a Server


1. Select a server type from the three radio buttons.
2. Enter a Server Name on the right side of the screen, listed under details.
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3.
4.
5.
6.
7.
8.

Enter a Server AE Title.


Enter Server IP Address.
Enter Server Port.
Enter Connection Timeout.
Enter Device AE Title.
User may choose to select the Use Static IP box, and then enter:
System IP Address
System Subnet
System Gateway
9. To make this the default server, check the Default Server checkbox.
10. Press the Save button.
11. Server should appear in list on the left.

24. Update a Server


1.
2.
3.
4.
5.

Select a server type.


Select a server from the list.
Modify parameters.
Press Update.
Server should acknowledge that the change was successful, and then reflect
changes made.

25. Delete a Server


1. Select a server type.
2. Select a server.
3. If Delete button is unavailable, verify the default server has not been selected,
as it cannot be deleted.
4. Press Delete.
5. Server will be removed from the list.

26. Echo Server


1.
2.
3.
4.

Select a server type.


Select a server.
Press Echo.
Status of server should appear.

27. Modify Server Order


1.
2.
3.
4.
5.

Select a server type.


Select a server.
Press the Up arrow button to move the server up in the list.
Press the Down arrow button to move the server down in the list.
Press the Save button to save the server order.

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28. DICOM Settings

Figure 30: DICOM Settings Window

Figure 31: DICOM Settings Tool Bar


User may choose to add or remove optional information to be displayed in the
HIS/RIS Query
MPPS
Patient Module
Study Module
Series Module
Image Module
Changes may be completed by pressing the Save button, or set back to the defaults by
pressing Reset.

29. Dose Configuration


1. Dose Check

Figure 32: Dose Check Window


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2. To set a dose limit, user may select:


dose check type
o notification is per scan
o alert is total accumulation),
a scan type
a CTDIvol (mGy) and/or DLP (mGy.cm) value
3. Press Save. A prompt will be displayed for saving success.
4. To remove a dose limit, select the dose check and scan type. If the system has
been configured with a particular setting it is displayed. User may clear the
CTDIvol (mGy) and DLP (mGy.cm) values and press Save. The user is prompted
of the save success and because the CTDIvol (mGy) and DLP (mGy.cm) are
empty, there is no longer a limit.
5. Dose Configuration

Figure 33: Dose Configuration Window


To set a maximum dose level for a particular protocol, user may choose a body region
using the colored dots, whether the protocol is adult or pediatric, and select a scan
type. The Saved Dose list is populated and the Save and Update buttons are then
available:
To save, enter a description, weight (for pediatric), height (for pediatric), a
kV setting, and a maximum mA setting for that kV. Then press Save. If the
level overlaps an existing level the user is prompted to make adjustments.
To update, select a dose level and adjust the displayed parameters. Then,
press the Update button. If the adjustments cause the level to overlap an
existing level the user is prompted to make adjustments.
To clear a particular setting to no longer have a restriction, select a saved dose from
the list and press Delete. To delete all settings, press the Delete All button which
returns all settings for that particular selection to the maximum scanner default.
Note: When this feature is enabled as noted above, the system will prevent
the patient from receiving any possible deterministic effects due to excess
dose by having the default limit of 1 Gy CTDI.

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30. Windowing Presets


Find or delete existing windowing presets, update an existing windowing preset, or
create and save a new windowing preset.

Figure 34: Dose Configuration Window

31. Update Account


User can modify the last and first name associated with the account, along with the
password for the account, which must be entered twice for verification. To update
the user account the user presses the Update button.

Figure 35: Update Account Window

32. Column Settings


1. HIS/RIS Query

Figure 36: Column Settings Window (View 1)


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2. Patient Browser

Figure 37: Update Account Window (View 2)


When any of the three main radio buttons is selected a table is created that lists the
columns, along with a checkbox to indicate whether it will be displayed within the
table. Columns that are required to be present cannot be unchecked and are colored
orange instead of the default green. A user with administrative privileges may press
the Make Default button to make the selected column display the default for all user
accounts that do not override the default with a unique setting. Press Save to keep
the settings in the system for future use.

33. Scan Dosage Report

Figure 38: Scan Dose Report Window


1. To view dosages taken during a particular day, select a date range and a scan
type. (The mA Range is defaulted to 20-30, and can be changed after the data
has been retrieved.) If date and protocol selections are blank, all doses for all
dates and protocols are retrieved.
2. User may then press the View button and a graph appears showing the dosages
performed by the scanner for that criteria and particular mA range. Adjusting
the mA range displays those ranges within the retrieved data.
3. Entered criteria can be cleared by pressing the Clear button.
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Chapter 4 - Scanning Basics


This chapter discusses the basics of performing a scan from the NL4000 BodyTom .
System setup and patient positioning are addressed in this chapter. Reading this
chapter from start to finish gives a general understanding of how to perform a scan.

1. Contraindication(s)
There are no contraindications associated with Computed Tomography X-ray scanning

2. Physical Setup, Patient, and Scanner Positioning


Note: After respective peripherals are properly plugged in, make sure that all
applicable power switches are in the ON position before being used.

Note : For any devices connected to an AC outlet, make sure the outlet itself
is providing the required power.

1. Drive scanner into room using the transportation system.

Figure 39: Patient Position Prep (BodyTom Front View)

If available, plug in scanner at the nearest outlet.

CAUTION: The BodyTom (NL4000) operating voltage ranges from 100 to 240 VAC, so
for domestic purposes, the scanner can be powered using use either 120 VAC or 240
VAC. If the scanner is using 120 VAC, then the facilitys plug (circuit) must be capable
of providing 20 Amps (Single Phase). If the scanner is using 240 VAC, then the
facilitys plug (circuit) must be capable of providing 30 Amps (Single Phase). If other
devices are connected to the same circuit, the facilitys circuit breaker may trip and
therefore cause the scanner to not be ready when needed.

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2. Bring workstation into room, and plug into nearest available outlet.

Figure 40: Workstation

Log into the workstation.

Figure 41: WorkStation Login Window


o If wireless, verify connectivity to scanner.
o If hardwired, plug the supplied Ethernet cable into the workstation cart.

Figure 42: Control Panel showing Ethernet Cable Connected

3. Patient Support/Bed
1. Ensure patient support is a radiolucent support (2mm equivalent Aluminum or
better) that is designed to be used with X-Ray Equipment.
2. If torso scanning is being done, then ensure the patient support is respectively
cantilevered (i.e. supported on one side).
Note: NeuroLogica Corp. recommends using Mizuho OSI INSITE or
equivalent as a patient support.

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WARNING: If a non-radiolucent patient support is used, then it may contain features


(e.g. sharp edges, metal screws, etc.) that have the potential to cause image artifacts,
which may interfere with diagnosis and/or cause a patient to be re-scanned.
3. Position the scanner at head of the patient support. Visually align the table
with the opening of the scanner to prevent a collision with the patient, patient
support and/or the life supporting devices prior to scanning.
Note: The scanner should translate without any interference.
4. Verify that the patient support is locked.
5. Lower the scanner onto centipedes.
6. Adjust the height of the patient support so that the patient is roughly centered within
the bore.

WARNING: Make sure to have the foot pedal brake engaged on the patient
support/bed to prevent said patient support/bed from moving during the scan.

Figure 43: Patient in bore (Height Positioning)

4. Pendant Control
WARNING: Pendants should be stored in the pendant holders when not in use by the
operator to prevent inadvertent contact by patient or operator.
1. Press the On button on the scanner.
2. Next, the Pendant Remote is used to translate the systems. See the next step
for all command buttons on the Pendant Remote.
3. For all Pendant Button commands see the following two figures:

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Figure 44: Pendant Remote


POWER: The power light will illuminate when power is supplies
to the pendant. If not on the pendant may not be attached to
the gantry correctly
LASER: The laser will turn on all position lasers for 30 seconds.
During that time the gantry will spin to so that the internal
laser can be seen within the gantry opening.
Go TO THE SCAN PLANE: Pressing the button will move the
gantry approximately 30 cm backwards. This is the distance
between the position lasers and the scan laser.
ZERO REFERENCE: Pressing this button will zero out the gantry
position.
GANTRY FORWARD SLOW: Holding the button down will
translate the gantry at 6 cm per second.
GANTRY BACKWARD SLOW: Holding the button down will
translate the gantry at 6 cm per second.
GANTRY FORWARD FAST: Holding the button down will
translate the gantry at 10 mm per second
GANTRY BACKWARD FAST: Holding the button down will
translate the gantry at 10 mm per second
SET MEMORY: Pressing this button will illuminate and activate
the storage mode.
Once this button is in the activated (illuminated) position, the
gantry can be moved using the arrow keys to the position
desired. Once at said position, save it to either the Scan
Position or Rest Position memory. The Set Memory button
MUST be pressed each time to save a new position.
SCAN POSITION: Pressing the button will translate the gantry a
programmed distance. See SET MEMORY
REST POSITION: Pressing the button will translate the gantry a
programmed distance. See SET MEMORY

Figure 45: Pendant Remote Buttons


4. Using the pendant, translate scanner over the patient table while carefully
monitoring that the bed does not hit bottom of the bore. Raise table if needed.
5. Continue to translate the scanner until the area of interest is reached.
6. Use positioning lasers on the pendant to center patient within the bore.

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Figure 46: Pendant use for positioning lasers upon patient

There are four lasers available to help with positioning vertical, centering,
and scan plane. All lasers are accurate to within 1 mm of the actual
position. The Scan plan laser points to the middle of the detector array.
To adjust vertical or horizontal positions, use table controls only.
To adjust the z-axis, crawl the scanner using pendant.

CAUTION: The use of shielding (e.g. lead vest/apron, etc.) is recommended when
performing equipment calibrations and patient scans to ensure maximum efficiency
and patient safety.

WARNING: Prior to scanning, the patient should be properly positioned to ensure that
extemeities, hair, life support equipment, etc. have sufficient clearance to prevent
patient injury with the scanner itself and/or when used with accessories/options.

WARNING: Care needs to be taken to ensure the patient support is properly


positioned (height and alignment) to prevent injury during scanning.

WARNING: Make sure to have the brake engaged on the patient support/bed to
prevent said patient support/bed from moving during the scan.

WARNING: Make sure to NEVER raise or lower (with the Up/Down rocker switch
located near the Control Panel) the scanner when a patient has been positioned into
the systems bore. ALWAYS slide the patient support away (by disengaging its brake)
from the system before raising or lowering the system itself.
1. Check to ensure that the patient is properly positioned and is comfortable.
2. Prior to scanning patients, check to ensure that there are no interferences with
the patients life support or other external medical devices

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5. Scanning
1. Be sure to complete all of the steps outlined above for patient and scanner
positioning before beginning the scan.
2. Register patient at the workstation (see chapter 5 for details).

Figure 47: Patient Registration Icon


3. Select a protocol.

Figure 48: Protocol Selection Window


4. Press Begin on the workstation. The scanner will prepare for the scan.

Figure 49: Begin Icon


5. The workstation will then display a window to perform a zero reference. Using
the pendant, make sure to press the zero reference button
as shown on the
next figure before either pressing Continue or Cancel.

Figure 50: Scanner Position Window Zero Reference


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Note: If the scanner does not get zero referenced then it will consider the
ending point of the last scan to be the origin/start point of the next scan.
This may misdirect the scanner when it begins the said next scan depending
on the parameters used. Therefore, always make sure to zero reference each
time.

6. After the zero reference is done, the scanner is ready when:


A notification appears on the workstation screen.

Figure 51: System Ready to Scan Window

Figure 52: Operator Control Panel


The START feature is enabled when it is lit green. Pressing the START button will
begin the countdown to x-ray exposure. When the countdown reaches 0 the exposure
will begin immediately. Once the button is pressed the button will transition and the
green light will turn off and a sequence of green halo lights will begin to rotate
around the button. This signifies that the operator has pressed the button with
enough force to initiate the sequence.
The CANCEL feature is enabled when it is lit blue. If the button is not lit blue then
CANCEL is disabled and pressing the button will not perform any function if
pressed. If pressed when lit then the system will cancel the current scanning
operation in an orderly fashion. If pressed during scanning the current scan rotation
will complete and then terminate.
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7. Press Start on the scanner..

WARNING: Do not stand in the either the forward or reverse translating paths of the
scanner during the scan.
Note: The scanners side panels provide a low radiation exposure rate of
<0.01mR/sec/100mAs when x-ray is emitted . Reference Scatter plot in chapter
11.
Note: A START button (from chapter 4) is used for this system to prevent
unintentional activation of X-ray tube.
Note: The following visual indication is provided to the operator a message
stating Scan has been terminated appears on both the scanner and
workstation.
Note: The scanner will terminate X-ray within 1 second or 1 rotation.

A 10 second countdown is displayed on the scanner.

Figure 53: Countdown Window


Note: The countdown time showing 7 Seconds in the above figure is for
example only.

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8. Images will be displayed on workstation screen as they are acquired.

Figure 54: Workstation Screen


9. If no more scans need to be taken, use the pendant remote (see figure in
Chapter 4) to translate the scanner away from the table. If more scans are
needed, return to step 3.
10. Once scanner is clear from the patient bed, press the Transport button on the
scanner. Lift the scanner.

CAUTION: Prior to transporting the Scanner verify that the Ethernet cable is
unplugged from workstation to avoid damage to the cable and outlet.

CAUTION: Prior to transporting the Scanner verify that the power cable is unplugged
from the wall to avoid damage to the cord and outlet.
11. Remove system from the room.

Figure 55: Scanner Removal Prep (BodyTom Front View)


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Chapter 5 - Workstation Scanning


This chapter is an overview on getting familiar with using the workstation to perform
a patient examination. Detailed instructions on using the Patient Registration
Worklist, Acquisition, and Post Reconstruction screens on the workstation are
provided.
Note: In clinical practice, the use of Radredux (only available in Head
protocols) may reduce CT patient dose depending on the clinical task, patient
size, anatomical location, and clinical practice. A consultation with a
radiologist and a physicist should be made to determine the appropriate dose
to obtain diagnostic image quality for the particular clinical task.

1. The Basics
The workstation is broken up into five major sections, each represented by a tab on
the main application screen.

Figure 56: Workstation Tabs


We will focus on the first three tabs. These sections are related to performing an
examination using the workstation:
1. Patient Registration Register a patient from the hospital/clinics HIS/RIS.
2. Acquisition Perform the examination.
3. Post Reconstruction Reconstruct the acquired protocols at different settings if
necessary.

2. Patient Registration

Figure 57: Patient Registration Window


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After login, the Patient Registration screen is displayed. This page is where the user
registers a patient for examination, and is set up with the Query Results list on top
and the Stored Results listed below (if enabled).
The following buttons are listed at the bottom center of the Patient Registration
page. Many of them are only enabled once the Query results have loaded, and a
patient has been selected / highlighted.
Buttons
Search the HIS/RIS server for scheduled patients. Depending on
the number of entries, this could take several minutes.
Cancel current query. Entries retrieved prior to cancellation will
be displayed in the query results.
Register selected patient, and proceed to the Acquisition screen.

View selected patient details.

Search queried patient entries for specific information.

Select patient(s) from the query results and move them into the
Stored Results table.
Delete patient(s) from the Stored Results table.

Manually enter a new patient and proceed to the Acquisition


screen.
Scroll through multiple pages of query results.

Figure 58: Patient Registration Buttons

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3. Perform Query Steps


1. After logging into the workstation, the user will be automatically directed to
the Patient Registration tab.
2. Select the Query button.
3. The Query Information window will be displayed
Select a HIS/RIS Server (The default will be displayed).
Enter appropriate information into the Value column of the table. Users
may enter as much, or as little information as needed. If no information is
available, values may be left blank.

Figure 59: Query Information Window (Patient Registration)


4. Press the Query button.
5. A list of patients matching the selected criteria will be populated in the Patient
Registration window.
6. Once the list is populated patients details can be viewed, registered for an
exam, and saved to a local stored list.

4. Create a Stored List


To create a stored list, select patient(s) from the query results. Press the Store
button, and the patients will be moved to the Stored Results list (if configured) at the
bottom of the Patient Registration screen. This convenience list is helpful when
multiple patients need to be scanned, and the connectivity to the HIS/RIS is
unavailable at the exam location.

5. Delete a Stored Procedure


1. Select one or more stored procedures from the Stored Procedure table.
2. Press the delete button (under the Stored Procedure table).
3. The selected procedures are removed from the Stored Procedure table.

6. Manually Register a Patient


Manually registering a patient for examination is normally used when the HIS/RIS
server is unavailable, or cannot be found. Press the Manual button located at the
bottom of the Patient Registration screen, enter all of the necessary patient and
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study information, and then press the Register button. The user will be automatically
directed to the Acquisition screen.

7. Acquisition
The Acquisition screen is where the examinations are performed.

Figure 60: Acquisition Screen

CAUTION: When conducting multiple or repeat scans, ensure that the total exposure
does not exceed the maximum limit defined as1 GY CTDI.
Buttons
Protocol Allows the user to select an existing protocol for the
current study.
Prompts the application to send the selected protocol to the
scanner and verify that the scanner has the tube/battery capacity
to perform the protocol.
Continue- Authorizes the scanner to proceed to the next protocol
(if applicable).
Start Recons Initiates any post-reconstructions that were defined
during protocol setup.

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Repeat The last protocol completed is performed again.


Extend - Adds onto the existing protocol x number of
millimeters.
Pause Scan Suspends current scan.

Cancel Scan Cancels the current scan within a protocol.

Pause Exam Suspends multi-step protocol.


Cancel Exam Cancels entire protocol.

Finalize Completes examination.


Figure 61: Acquisition Buttons
General patient identification information, used to verify correct patient has been
registered.

Figure 62: Patient Exam Details (Acquisition Screen ~ Close-up)

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Displays the power settings and patient dose information for the current scan.

Figure 63: Current Scan Details (Acquisition Screen ~ Close-up)


Patient position relative to gantry opening:
HFS
head first-supine
HFP
head first-prone
HFDL
head first-decubitus left
HFDR
head first-decubitus right
FFS
feet first-supine
FFP
feet first-prone
FFDL
feet first-decubitus left
FFDR
feet first-decubitus right

Figure 64: Patient Position Screen


Active Scan Region If the protocol contains one or more scouts, the application will
place the scan region for each series on the scout based on the start and end positions
entered for each series in the protocol. The Active Scan Region drop down will be
populated with the ID that corresponds to each region. The user can adjust a scan
region prior to continuing the exam.
Grid Displays a grid overlay over the image for alignment. To create grid, select
active region, define grid size in millimeters.

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Figure 65: Viewing Tools (Acquisition Screen ~ Close-up)


Tools
Clear Active Tool Resets tool to default pointer device.

Windowing Tool Adjust width and level of the selected image.

Zoom Tool Magnifies the image

Pan Tool Adjusts the image in the XY axis.

Show/Hide Scouts Removes scouts from acquisition screen.

Adjust Layout (1 x 1) or (2 x 2).


Finalize Exam Completes all protocols, builds Dose SR and
Images, and directs user to the Patient Browser screen.

Scan Region Re-Draw.

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Bolus Reference ROI Draws ROI on an artery or vein to track


contrast.
Figure 66: Viewing Tools Buttons
Adjust window width and center of the image.

Figure 67: Windowing (Acquisition Screen ~ Close-up)


Magnifies viewport by the defined value.

Figure 68: Zoom (Acquisition Screen ~ Close-up)

8. Perform Acquisition Steps


Note: Please be aware that depending on the systems configuration, the
ability to perform certain types of protocols may not be available.

1. From the Patient Registration page select a patient from Query Results or
Stored Results table and press the Register button. Users may also manually
register a patient by pressing the Manual button.
For instructions on how to register a patient from the Patient Browser
screen, please see Chapter 5.
Note: After performing Step 1, described above, verify that the correct
information for the patient registered is displayed on the scanner. This will
prevent images from being associated with the incorrect patient.
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2. User will be automatically redirected to the Acquisition screen.


3. Press the Protocol button and the Exam Planner window will be displayed.

Figure 69: Protocol Selection Window


From this screen, the user may choose either an adult or pediatric patient, and then
select the colored dot corresponding to desired anatomical region to see a list of
available protocols.
These protocols may be edited (if necessary) by selecting the Edit button,
opening the Edit Protocol window.
Enter the desired changes and press the Update button at the bottom of the
screen to save the information. Press Reset to set the altered information
back to the default setting.
User may also press the Validate button and the application will send the
selected protocol to the scanner to verify the scanner has the tube/battery
capacity to perform the protocol.

Figure 70: Protocol Information Screen

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4. Once changes are complete, highlight the desired protocol from the list on the
Exam Planner window.
5. Press Begin on the Exam Planner window and the popup will close, displaying
the Acquisition screen again. The Patient Position box will be automatically
adjusted according the selected protocol.
Note: Be aware that modifications to any protocol in the Exam Planner are for
that session only. If the protocol is multi-protocol, modifying the slice
thickness x spacing, and pitch (Helical protocols), regardless of the user
privilege will not be allowed.

6. The system will now be ready to scan.

Figure 71: System Ready to Scan Window


7. Press Start on the scanner device. There will be a ten second countdown
displayed.

Figure 72: System Ready to Scan Window

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Note: The countdown time showing 7 Seconds in the above figure is for
example only.

8. Once scanning has begun, the Continue, Repeat, Extend, Pause Scan, Pause
Exam, Cancel Scan, and Cancel Exam buttons will be enabled.
9. Continue scanning until all protocols are complete, and all images have been
captured.
10. Once exam is complete, Current Scan information will be filled in and the
Viewing Tools, Windowing, and Zoom boxes will be enabled and available for
use.
11. Press Finalize to complete the procedure and be directed to the Patient
Browser screen.
Note: Finalizing or registering another patient MUST be done PRIOR to sending
the active patients data to the hospitals PACS system. Otherwise, the latest
information will NOT be sent to the hospitals PACS system.
Note: If a patient is accidentally scanned under the wrong identification
please see Chapter 6 Patient Browser, for details on how to adjust series
to reflect correct information.

9. Perform a Reference Scan


A reference scan is used when the patient is in the correct position, and user would
like one shot to be taken to see where they are. This snapshot/preview verifies
correct scanner position. Users may choose this option when selecting/updating a
protocol.

10. Screen Setup


Each screen is broken into several sections. Although all of the screens are different,
there are a few parts that remain constant no matter which tab is being displayed:
1. User, Date and Time Information (Top, Center) Displays a greeting along with
the User Name, Current Date, and Current Time.
2. Main Menu options (Top, Left) please see Chapter 2 for details.
3. Scanner and Workstation Status Information (Top, Right) Displays status
information for both the scanner and workstation:

Figure 73: Workstation/Scanner Status Bar


X-ray Status: Icon will change from gray to yellow when X-ray is on.

System State: Each color orb represents a system state


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Dark Gray = Unknown

Light Gray = Power Up & Power


Down

Dark Purple = Pause Series &


Pause Exam

Purple = Air Calibration

Light Purple = Archiving

Blue = Idle

Green = Ready

Light Yellow = Planning

Dark Yellow = Preparing

Light Orange = Reconstruction

Dark Orange = Scanning

Pink = Not Ready

Red = Fault

System Position: The current position of the system relative to its zero reference
is displayed on the bottom right hand corner.

System Centipede Status: The arrow display on the bottom right hand corner will
indicate if the centipede system is engaged (arrow down) or disengaged (arrow
up).

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System Emergency Stop Status: The Emergency Stop (EMO) Icon will brighten
when the EMO swtich has been engaged.

System Air Freshness Status: Each colored bar represents a particular freshness
percentage red 100%-51%, yellow 50%-15%, green 14%-0%.

System Tube Capacity Status: Each colored orb represents a particular capacity
percentage red 100%-75%, orange 74%-50%, yellow 49%-25%, blue 24%-0%.

System Battery State of Charge Status: Each colored orb represents a particular
state of charge percentage green 100%-50%, yellow 49%-25%, red 24%-0%. A
Charge icon will appear on the top left hand corner when the system is plugged
into an outlet.
Workstation Free Disk Space Status: Each colored orb represents a particular
space percentagegreen 100%-50% free space, yellow 50%-20% free space, red
20%-0% free space.
Workstation Battery State of Charge (if purchased option): Each colored orb
represents a particular state of charge percentage green 100%-20%, yellow 20%10% (user will be prompted to plug the workstation into an outlet to charge. A
scan may not be able to complete with such low battery levels), red 10%-0% (once
the workstation reaches this state of charge range, system will gracefully
shutdown).
Figure 74: Workstation/Scanner Status Details by Icon

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11. Post Reconstruction


The system allows reconstruction of a series after the examination has ended. The
system stores multiple patients series to allow post reconstruction hours, possibly
even days after the patient examination has ended.

Figure 75: Post Reconstruction Screen


The screen is broken up into two sections:
1. Available Series Provides a list of the series currently stored on the system.
2. Reconstruction Parameters Allows the user to select the reconstruction
parameters.
Reconstruction Parameters

Figure 76: Reconstruction Parameters (Post Reconstruction Screen ~ Close-up)


Image Sharpness can be modified by the following kernels:
Low Noise QA
Bone
Soft Tissue
Sharp Lung
Pos. Fossa / Vessel
High Res QA
Sharp
Slice Thickness (mm) /Spacing (mm) can be adjusted to:
1.25 X 1.25
5.0 X 5.0
2.5 X 2.5
10.0 X 10.0
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Metal Artifact Removal Mitigates the effects of metal within the image.
Customize Bone Correction Adjusts the contrast between the bone-brain interface.
Image Range Reconstructs images defined within the range. If no range is selected,
all images will be reconstructed.
Noise Reduction Reconstruct the images to compensate for high noise levels. High
aggressive noise suppression, low = mild noise suppression.
Generate Axial / Coronal / Sagittal Generates Axial (step and shoot), Coronal, or
Sagittal images from the acquired data set.
Tools

Stop Cancels the current post reconstruction request. All images


generated up until stop is pressed are stored.
Field of View Adjusts the area of interest prior to the generation of
images.

Clear Active Tool Resets tool to default pointer device.

Windowing Tool Adjust width and level of the selected image.

Zoom Tool Magnifies the image.

Pan Tool Adjusts image on the XY axis.

Reset Resets display to the default viewer settings.

Figure 77: Post Reconstruction Buttons

BodyTom is a registered trademark of NeuroLogica Corporation

12. Perform Post Reconstruction Steps


1. Verify available studies to reconstruct.
2. Use mouse to select a study All available studies are displayed in the browser.
3. Select reconstruction parameters
Sharpness *Mandatory
Slice Thickness / Spacing *Mandatory
Image Range
Noise Reduction
4. Select any additional corrections using the checkbox supplied
Metal Artifact Removal
Customized Bone Correction
Generate Axial/Coronal/Sagittal
5. Press Start to generate new data set.
6. Images will be displayed in image viewport on right.
7. To terminate reconstruction prior to completion, Press Cancel.

13. Finalize Exam


There are two options for completing a patient examination:
1. Press the Finalize Exam button on Acquisition Screen.
2. Register a new patient.
When the exam is finalized, the Exam Details will be saved. Also, if auto print and/or
auto store options are configured, they will be performed at this time. If the Dose
Report setting is selected in the Configuration Manager, the dose report is generated,
and displayed at this time. Click the Save button to save the report.
Note: Finalizing or registering another patient MUST be done PRIOR to sending
the active patients data to the hospitals PACS system. Otherwise, the latest
information will NOT be sent to the hospitals PACS system.
Note: If a patient is accidentally scanned under the wrong identification
please see Chapter 6 Patient Browser & Viewing, for details on how to
adjust series to reflect correct information.

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Chapter 6 Patient Browser and Viewing


This chapter is an overview on getting familiar with using the NL4000 BodyTom
workstation to perform various tasks involving examinations that have already taken
place. Detailed instructions on using the Patient Browser and Viewing screens on the
workstation are provided.

1. The Basics
As discussed in a previous chapter the workstation is broken up into five major
sections, each represented by a tab on the main application screen.

Figure 78: Workstation Tabs


Here we will focus on the last two tabs. These sections are related to performing
various tasks on existing series:

Patient Browser Gives access to all of the series stored on the workstation.
Viewing Advanced Image Analysis Tool.

2. Patient Browser

Figure 79: Patient Browser


The Patient Browser provides the user with the means to perform particular tasks on
existing patients, such as archiving and printing.

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The screen is where the results from the query are displayed and particular tasks are
presented:

Locked Indicates that the series cannot be deleted.


Archived Indicates that the series has been sent to PACS.
Marked Indicates that the series is marked.

Buttons
Select archive destination for selected information.

Import exam information from PACS or Media.

Delete selected exam information from the patient browser.


Opens Create New Study window and moves selected patient to
the Acquisition screen.
Generates dose for a particular patient.

Combine two different series and review on the Viewing page.

Open selected exam images in the Viewing page.

View patient, study, series, or image information.


Figure 80: Patient Browser Buttons
Examination Table.

Figure 81: Examination Table (PT Browser ~ Close-up)


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Series Table.

Figure 82: Series Table (PT Browser ~ Close-up)


Series Protocol Table.

Figure 83: Series Protocol Table (PT Browser ~ Close-up)


Series Image Table.

Figure 84: Series Image Table (PT Browser ~ Close-up)


Image Preview.

Figure 85: Image Preview Screen (PT Browser ~ Close-up)

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Store/Print Queue

Figure 86: Store/Print Queue Screen


Buttons
Temporarily stops the series from being stored.

Continues storing paused series.


Select and delete either a series to be stored, or a series that
failed to store.
Try again to store a failed series.

Display explanation of why a series failed to store.

Close the Store/Print Queue window.


Figure 87: Store/Print Queue Buttons

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3. Archive to PACS
1. Press the Archive/Print button on the Patient Browser tab.
2. The Archive Destination window will appear.

Figure 88: Archive Destination Window


3. Three options are available:
PACS List
Media
Film
4. The option of selecting a range of images to archive for each series to then
send to PACS is available as needed.
5. Press the PACS button to open the Archive to Server window, and select
appropriate archive location and Image range.

Figure 89: Archive to server Window


6. Press Archive to send the archive job to the Store/Print Queue.
7. To watch the progress of the archive job open the Store/Print Queue: Select
the Tools menu followed by the Store/Print Queue menu item.

Figure 90: Tools Pull Down Menu

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8. The archive job will appear in the Current Store/Print Jobs table. The following
information is displayed:
Patient Name
Series Description
Protocol
Server Name
Status
o Pending archive job is in the queue waiting to be archived
o Storing archive job is currently being stored to PACS.
Number of Images Remaining
9. If the archive job fails, it will be sent to the Failed Store/Print Jobs table. If a
job fails, user may press the details button for explanation.
10. To delete a failed archive job, press the Delete button.
11. To suspend the queue, press the Pause button. Suspending the queue will cause
the queue to finish the current job and stop.
12. If the queue is suspended, it can be resumed by pressing the Resume button.
13. To close the queue, press the Close button.
14. If the job is sent successfully it will be removed from the queue.

4. Print
1. Press the Print button.
2. The Send to Printer popup appears.
3. Two options are available:
Configured default printer
Select a particular printer
4. The option of selecting a range of images to archive for each series to then
send to PACS is available.
5. Press the Preferences button to open the preferences popup.
6. To change any preferences, choose and press the Apply button.
Note: Be aware that these settings are for this print session only and will not
be saved.

7. Press the Print button when ready to print.


8. To watch the progress of the print job, open the Store/Print Queue (See above
Archive to PACS section for queue details).

5. Delete Series
1. Select one or more series to be deleted.
2. Press the Delete button.
3. Confirmation popup will appear. Press yes to continue, press no to cancel
deletion process.
4. Deletion Progress popup will appear, and status bar will fill rapidly as the
selected series are deleted.
5. Press the Cancel button at any time to stop the deletion process.
6. The deleted series are removed from the Query results table.

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6. Lock Series
1.
2.
3.
4.
5.
6.

Select one or more series to be locked.


Press the lock button.
The lock icon will become visible for the selected series.
Deleting the series while in a locked state cannot be done.
To unlock the series, repeat steps 1-2, the lock icon will dim when unlocked.
Users may also right click on a series, and select Lock or Unlock from the drop
down menu.

Note: All QA Series are locked to prevent deletion. They cannot be unlocked.

7. Mark Series
1.
2.
3.
4.
5.

Select one or more series to be marked.


Press the Mark button.
The marked icon will become visible for the selected series.
To unmark, repeat steps 1-2, the marked icon will dim when unmarked.
Users may also right-click on a series, and select Mark or Unmark from the drop
down menu.

8. Merge Series
1. From the Patient Browser tab, select two series to merge.
2. Press the Merge button on the right of the screen.
3. A window will be displayed informing user that the application is gathering the
images. (Note: Both images must have the same protocol, slice thickness, slice
spacing, kernel, and pixel spacing in order to successfully merge the two
series).
4. The Merge window will be displayed.

Figure 91: Merge Window

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5. First set of images will load on the left side of the Merge screen.
6. Second set of images will load on the right side of the Merge screen.
7. Several image tools are available for use:
Adjust Window Width and Level
Pan Image
Zoom Tool
Clear Active Tool
8. By right-clicking on either image set, user may Select All or Deselect All images.
9. Drag image(s) from either series into the center viewport and user may scroll
through them.
10. Drag images into the merge bar at the bottom of the page and set the desired
location.
11. The Merge button will become available.
12. Press the Merge button.
13. A pop-up window will be displayed alerting the user that the merge series has
been saved successfully. Press the Ok button, then select Close to close the
window and return to the Patient Browser screen.
14. An additional series is produced from the two selected series. The merged
series can be identified by the merged tag at the end of the protocol name.
15. To verify the merge, press the Review button (See Viewing section for details).

9. Register Patient
1. Begin by selecting a respective series to register a patient for an examination.
2. Press the Register button.
3. The Acquisition screen is then displayed. Please see Chapter 5 Workstation
Scanning for further details.

10. Load Series into Viewing


1.
2.
3.
4.

Select a series.
Press the Review button.
Loading progress will appear.
Once the images are loaded into viewing, the Viewing screen is then displayed.
Please see the Viewing section for further details.

11. View/Update Series


1. Select a patient from the Patient Browser list, and then choose a series to view.
2. Press the View/Update button.
3. View/Update Information popup appears, to begin modifying any editable fields.

Figure 92: View/Update Pop-up Window

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4. To update the Patient, Study and/or Series information, press the Update
button.
5. Press Close to exit the View/Update Information popup.

12. Modify Series Scanned Under Wrong Patient


If a patient has been accidentally scanned under the wrong identification the series
can be fixed by doing the following:
1. From the Patient Browser screen, select the series that was scanned with
incorrect patient identification.
2. Press View/Update button.

Figure 93: View/Update Button (View/Update Info Window)


3. The View/Update Information window will be displayed.

Figure 94: View/Update Pop-up Window


4. Press the Move button.

Figure 95: Move Button (View/Update Info Window)


5. A popup will be displayed denoting where to retrieve the patient information
from:

Figure 96: Move Series Window


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Registration if the patient information is stored within the hospitals


HIS/RIS Server, press this button to be taken to the Register Patient screen
to choose the patient/study information.
Browser if the patient information is stored within the systems browser,
press this button to be taken to the Patient Browser to select a series with
the correct patient information.
6. When brought to one of the above screens, the only option is to select a
patient and press the Move or Manual button.
Press the Manual button, and the Exam Information window will be
displayed. Enter the correct information, and press the Move button. User
will be prompted to review the changes made to the patient/series
information in order for the changes to take effect.
Select the correct patient from the list, and press the Move button. User
will be prompted to review the changes made to the patient/series
information in order for the changes to take effect.
7. If the information selected appears correctly, press Update. If the information
is still incorrect repeat steps 3 6.
8. Press Cancel to abort the process.

13. View/Update QA Series


1. Select QA series to view.
2. Press the View/Update button.
3. Now, use the QA Information tab.
4. This tab displays all the information regarding the QA Image.
5. To export this information, press the Export button.
6. The Export QA Results popup will appear.
7. Select a drive to export to. Press Refresh to update the drive list.
8. Enter a file name.
9. Press Export.
10. Press Close when finished.

14. Import Series


1. To import series data into the workstation, select the Import button on the
Patient Browser screen.

Figure 97: Import Button (PT Browser)


2. The Import Location window will be displayed, and the user may choose to
import from PACS or Media.

Figure 98: Import Location Window

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3. A Drives folder will appear in the list, expand its contents to view the available
drives.
4. Select a drive and expand its contents.
5. Continue expanding until the file or folder to be imported is found.
To select a file, begin by selecting a single DICOM image, or a DICOMDIR
file. Selecting a DICOMDIR file will import all images related to that
particular DICOMDIR.
6. Press the Import button.

Figure 99: Import Button (PT Browser)


7. To minimize the window, select the Minimize button, and only a small folder
icon will be displayed at the bottom center of the screen.

Figure 100: Minimize Button (PT Browser)


8. To cancel the import at any time, press the Cancel button.

Figure 101: Cancel Button (Import Location Window)


9. Once the import is complete press the Close button to exit.
10. The Query Results table will update with the imported series.

15. Viewing
1. 2D Review
2-D allows the images to be viewed in 2-Dimensional space.

Figure 102: 2D View Screen


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2. MPR Review
MPR review allows the user to view the dataset in 3-Dimensions using three orthogonal views.

Figure 103: MPR View Screen


3. 3D Review
3D Review allows the dataset to be viewed in 3-Dimensional space.

Figure 104: 3D View Screen


4. Tools

Figure 105: 3D Tools Screen (Left)


Figure 106: MPR Tools Screen (Center)
Figure 107: 2D Tools Screen (Right)

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Clear Active Tool - Resets tool to default pointer device.

Windowing Tool - Adjust width and level of the selected image.

Zoom Tool - Magnifies the image.

Pan Tool - Adjusts image on the XY axis.

Region of Interest (ROI) Defines a circular region of interest


and displays ROI information.

Linear measurement Draws a line on the image and displays


length information.
Arrow Draws an arrow on the screen, which can be
repositioned.

Angle draws an angle on the image and displays angle


information.

Text allows a user to type in text on the image.

Reset Reverts all images back to the original state.

Rotate Used in 3D review, this tool rotates the image.

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Redo Performs the most recent action again.

Undo Removes the most recent action performed on the image.

Capture Takes a screen shot of the active image viewport.

Capture All Takes a screen shot of all image viewports.


Figure 108: View Screens Tool Buttons
Adjust window and center of the image, press apply for values to take effect.

Figure 109: Windowing (View Screens Tools ~ Close-up)


Alters the number of images presented on the viewing screen.

Figure 110: Layout (View Screens Tools ~ Close-up)


Magnifies viewport by the defined value.

Figure 111: Zoom (View Screens Tools ~ Close-up)

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Rotates the image on the screen on the X plane.

Figure 112: Rotate (View Screens Tools ~ Close-up)

Figure 113: Positioning (View Screens Tools ~ Close-up)


Reverse Stack reverses the order in which the images
are displayed.

Flip images up or down.

Flip images right or left.

Cine forwards/backwards through the image set, and


stop.
Figure 114: Positioning Buttons (View Screens Tools ~ Close-up)

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Allows user to do a side-by-side comparison of two different scans, and allows the two
different images to be altered at once.

Figure 115: Compare (View Screens Tools ~ Close-up)


Color map used for the 3D rendering. Users may select

Figure 116: Positioning (3D View Screen Tools ~ Close-up)

CT Angio 1
CT Angio 2

Trachea
Circle of Willis

Rendering techniques. Users may choose

Figure 117: Rendering (3D View Screen Tools ~ Close-up)

Color

Grayscale

MIP

Alters the position in which the images are displayed. User may choose

Figure 118: Orientation (3D View Screen Tools ~ Close-up)

Inferior
Superior

Anterior
Posterior

Right
Left

16. Save Preset


1. Press the WL Preset button. A Window Width and Level Presets popup will
appear:
2. Enter a preset name in the drop down text field.

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3. Enter width and level values.


4. Press Save button.

17. Delete Preset


1. Select a preset.
2. Press the Delete button.

18. Change Layout


1. Press the change layout button. The layout will change to 2x2. Repeat process
to return to 1x1.

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Chapter 7 - Compliance Requirements


1. Group 1 Class A Medical Devices
This equipment generates, uses, and can radiate radio frequency energy. The
equipment may cause radio frequency interference to other medical and non-medical
devices and to radio communications. To provide reasonable protection against such
interference, this product complies with emission limits for Group 1 Class A Medical
Devices as stated in EN 60601-1-2
However, there is no guarantee that interference will not occur in a particular
installation. If this equipment is found to cause interference (which may be
determined by switching the equipment on and off), the user (or qualified service
personnel) should attempt to correct the problem using one or more of the following
measures:

Re-orient or relocate the affected device(s)


Increase the separating space between the equipment and the affected
device
Power the equipment from a source different from that of the affected
device
Consult the point of purchase or the service representative for further
suggestions

NeuroLogica Corporation is not responsible for any interference caused either by the
use of interconnect cables other than those recommended or by unauthorized changes
or modifications to this equipment. Unauthorized changes or modifications could void
the users authority to operate the equipment.
To comply with the regulations applicable to an electromagnetic interface for a Group
1 Class A Medical Device.

All interconnect cables to peripheral devices must be shielded and properly


grounded.
Use of cables not properly shielded and grounded may result in the
equipment causing radio frequency interference in violation of the
European Union Medical Device Directive and FCC regulations.

CAUTION: Do not use the following devices near this equipment. Use of these devices
near this equipment could cause this equipment to malfunction.

Devices which intrinsically transmit radio waves such as; cellular phone,
radio transceiver, mobile radio transmitter, radio-controlled toy, etc.
Keep power to these devices turned off when near this equipment.
Medical staff in charge of this equipment is required to instruct technicians,
patients and other people who may be around this equipment to fully
comply with the above regulation.

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2. Compliance Statement
Note: All editions and years of revisions for standards noted in this
chapter are static as of revision 00 of this user manual.
The NL4000 BodyTom systems comply with the regulatory requirements of the
following:
UL 60601-1 (2003) Medical Electrical Equipment, Part1: General
Requirements for Safety
CAN/CSA C22.2 No 601.1-M90 (1990), 2nd Edition, Medical Electrical
Equipment, Part 1: General Requirements for Safety
CENELEC EN 60601-1 2nd Edition, Medical Electrical Equipment - Part 1:
General Requirements for Safety. Includes Amendment A1:1993 and
A2:1995
IEC 60601-1-1 (2000) 2nd Edition: Medical Electrical Equipment, Part 1:
General Requirements for Safety - Collateral Standard: Safety Requirements
for Medical Electrical Systems
IEC 60601-1-2 (2005) Medical Electrical Equipment, Part 1-2: General
Requirements for Safety - Collateral Standard: Electromagnetic
Compatibility
IEC 60601-2-28 (1993) Medical Electrical Equipment, Part 2: Particular
Requirements for the Safety of X-ray Source Assemblies and X-ray Tube
Assemblies for Medical Diagnosis
IEC 60601-2-32 (1994) Part 2-32, Particular Requirements for Safety sections
2.32 Specification for Associated Equipment of X-ray Equipment
IEC 60601-2-44 (2009) Medical Electrical Equipment -Part 2-44: Particular
requirements for the safety of X-ray equipment for Computed Tomography
IEC 60601-1-3 (2008), Medical Electrical Equipment section 1-3: General
requirements for safety. Collateral standard: General requirements for
radiation protection in diagnostic X-ray equipment
IEC 60601-1-4 (2000), Edition 1.1 Consolidated edition, Medical Electrical
Equipment Part 1-4: General Requirements for Safety Collateral Standard:
Programmable Electrical Medical Systems
International Electrotechnical Commission (IEC) International standards
organization, when applicable
NeuroLogica Corporation is ISO 9001-2008 and ISO-13485-2003 certified

3. EMI/EMC Glossary Terms


Electromagnetic Interference (EMI)
The ability of an electronic system to not be a source of electronic emission pollution
to the environment in which it operates. Both radiated and conducted emissions
contribute directly to the interference-causing potential of an electronic system.
Electromagnetic Compatibility (EMC)
The ability of an electronic system to function properly in its intended environment
without the susceptibility of interference from external sources.
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Susceptibility
The capability of an electronic system to respond to unwanted electrical energy
EMI/EMC Compliance
This equipment complies with IEC60601-1-2 Edition 2 (2001) EMC standard for medical
devices.
The NL4000 BodyTom systems are suitable to be used in an electromagnetic
environment, as per the limits & recommendations described in the tables hereafter:
Emission compliance level & limits (Table 1)
Immunity compliance level & recommendations to maintain equipment
clinical utility (Tables 2, 3 and 4)
Note: This system complies with above mentioned EMC standard when used
with supplied cables. If different cable lengths are required, contact a
qualified service representative for advice.

WARNING: Medical Electrical Equipment needs special precautions regarding EMC and
needs to be installed and put into service according to the electromagnetic
compatibility [EMC] information provided in the accompanying documents.

WARNING: Portable and mobile RF communications equipment can affect medical


electrical equipment.

WARNING: The equipment or system should not be used adjacent to or stacked with
other equipment and if adjacent or stacked use is necessary, the equipment or system
should be observed to verify normal operation in the configuration in which it will be
used
Note: The EMC tables and other guidelines that are included in this Manual
provide information to the customer or user that is essential in determining
the suitability of the Equipment or System for the Electromagnetic
Environment of use, and in managing the Electromagnetic Environment of use;
to permit the Equipment or System to perform its intended use without
disturbing other Equipment and Systems or non-medical electrical equipment.

Table 3: Emission Declaration for NL4000 BodyTom systems


The BODYTOM systems are intended for use in the electromagnetic
environment specified below. The customer or the user of a NL4000
BodyTom system should assure that it is used in such an environment.
Electromagnetic
Emissions Test
Compliance
Environment Guide
RF emissions
Group 1
The NL4000 BodyTom

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The BODYTOM systems are intended for use in the electromagnetic


environment specified below. The customer or the user of a NL4000
BodyTom system should assure that it is used in such an environment.
Electromagnetic
Emissions Test
Compliance
Environment Guide
CISPR 11
systems use RF energy
only for internal
function. Therefore,
the RF emissions are
very low and are not
likely to cause any
interference in nearby
electronic equipment.
The NL4000 BodyTom
systems are
predominantly
intended for use in
RF emissions
non-domestic
CISPR 11
Class A
environments, and not
directly connected to
the
Public Mains Network.
Harmonic emissions,
The NL4000 BodyTom
IEC 61000-3-2
Class A
systems are
predominantly
intended for use (e.g.
in hospitals) with an
Voltage fluctuations/
appropriate
flicker emissions,
Complies
power supply (see
IEC 61000-3-3
operation manual) and
the recommended
shielding for portable
use.
Table 4: EMC Immunity Declaration For NL4000 BodyTom systems
The BODYTOM systems are intended for use in the electromagnetic
environment specified below. The customer or the user of an NL4000
BodyTom system should assure that it is used in such
Electromagnetic
IEC 60601-1-2
Compliance
Immunity Test
Environment
Test Level
Level
Guidance
Floors should be
wood, concrete, or
Electrostatic
6 KV
ceramic tile. If floors
discharge
6 KV contact
contact
are covered with
(ESD)
8 KV air
8 KV air
synthetic material,
IEC 61000-4-2
the relative humidity
should be at least
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The BODYTOM systems are intended for use in the electromagnetic


environment specified below. The customer or the user of an NL4000
BodyTom system should assure that it is used in such
Electromagnetic
IEC 60601-1-2
Compliance
Immunity Test
Environment
Test Level
Level
Guidance
30%.
2 KV for
Mains power quality
2 KV for power power supply
should be that
Electrical fast
supply lines
lines
of a typical
transient/burst
1KV for input/
1KV for
commercial or
IEC 61000-4-4
output lines
input/output
hospital
lines
environment
Mains power quality
1 KV lineshould be that
1 KV line-line
Surge
line
of a typical
2KV lineIEC 61000-4-5
2KV linecommercial or
ground
ground
hospital
environment
Mains power quality
should be that
of a typical
>95% dip for
>95% dip for 0.5
commercial or
0.5 cycle
cycle
hospital
Voltage dips,
environment. If the
short
60% dip for 5
60% dip for 5
user of an NL4000
interruptions
cycles
cycles
BodyTom systems
and voltage
requires continued
variations on
30% dip for
operation during
30% dip for 25
power supply
25 cycles
power
cycles
input lines IEC
interruptions, it is
61000-4-11
>95% dip for
>95% dip for 5
recommended that
5 seconds for
the NL4000
seconds
5 sec.
BodyTom system
be powered from its
internal batteries
Electromagnetic
IEC 60601-1-2
Compliance
Immunity Test
Environment
Test Level
Level
Guidance
Power frequency
magnetic fields
Power
should be at levels
frequency (50/
characteristic of
60Hz)
3 A/m
3 A/m
a typical location in
magnetic field
a typical
IEC 61000-4-8
commercial or
hospital
environment.
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4. Countermeasures against EMC related issues


Generally it is very difficult to grapple with issues related to EMC. It may take much
time and cost.
General Countermeasure Electromagnetic interference with other equipment(s):

Electromagnetic interference may be alleviated by positioning other


equipment(s) far from the system.
Electromagnetic interference may be mitigated by changing the relative
location (installation angle) between the system and other equipment(s)
Electromagnetic interference may be eased by changing wiring locations of
power / signal cables of other equipment(s).
Electromagnetic influence may be reduced by altering the path of power
supply for other equipment(s).
Electromagnetic environment specified below Table 5 and Table 6.

Table 5: EMC Immunity Declaration


The NL4000 BodyTom systems are intended for use in the
electromagnetic environment specified below. The customer or the
user of an NL4000 BodyTom system should assure that it is used in
such an environment.
IEC 60601Electromagnetic
Immunity
Compliance
1-2
Level
Environment Guidance
Test
Test Level
Portable and mobile RF
communications equipment
should be used no closer to
any part of an NL4000
Conducted
BodyTom system, including
3 Vrms
RF
cables, than the
150 kHz to
V1 = 3 Vrms
IEC 61000-4recommended separation
80 MHz
6
distance calculated from the
equation appropriate for the
frequency of the transmitter.
Recommended Separation
Distance: See Table 6

Radiated RF
IEC 610004-3
(alternative
method: IEC
61000-4-21)

3 Vrms
80 MHz to
2,5 GHz

E1 = 3 V/m

NeuroLogica Document # 1-NL4000-060, Rev. 02

Where P is the maximum


power rating in watts and D is
the recommended separation
distance in meters.
Page 86 of 148

The NL4000 BodyTom systems are intended for use in the


electromagnetic environment specified below. The customer or the
user of an NL4000 BodyTom system should assure that it is used in
such an environment.
IEC 60601Immunity
Compliance
Electromagnetic
1-2
Test
Level
Environment Guidance
Test Level
Field strengths from fixed
transmitters, as determined
by an electromagnetic site
survey, should be less that
the compliance levels (V1 and
E1).
Interference may occur in the
vicinity of equipment marked
with the following symbol:

Table 6: EMC Recommended Separation Distances


Recommended separation distances between portable and mobile RF
communications equipment and an NL4000 BodyTom system.
The NL4000 BodyTom systems are intended for use in an
electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of a NL4000 BodyTom system
can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications
equipment (transmitters) and the NL4000 BodyTom system as
recommended below, according to the maximum output power of the
communications equipment.
Rated
Maximum
Output Power
(P) if
Transmitter
Watts (W)

150 kHz to
80 MHz
Separation
Distance
metersa

80 MHz to
800 MHz
Separation
Distance metersa

800 MHz to
2,5 GHz
Separation
Distance
metersa

0.01
0.12
0.12
0.23
0.1
.38
.38
.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above,
the separation distance can be estimated using the equation in the
corresponding column, where P is the maximum output power rating
of the transmitters in watts (W) according to the transmitter
manufacturer.
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Note: At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects, and people.
a
Separation distance according to frequency of transmitter (m)

5. Use Recommendations
This product complies with IEC 60601-1-2 Edition 2 (2001) EMC standard for medical
devices and with radio frequency emission requirements per CISPR11 Group1 Class A
standard limits. The NL4000 BodyTom systems are predominantly intended for use in
hospitals.
Do not use devices which intentionally transmit RF Signals (Cellular Phones,
Transceivers, or Radio Controlled Products) in the vicinity of this equipment as it may
cause performance outside the published specifications. Keep the power to these
types of devices turned off when near this equipment.
Adhering to the distance separation recommended in table 4 between 150 kHz & 2.5
GHz, w reduce disturbances recorded at the image level but may not eliminate all
disturbances. However, when installed and operated as specified herein, the system
will maintain its essential performance by continuing to safely acquire controlled
radiological X-ray exposures in a mobile radiography environment.
For example, a 1W mobile phone (800 MHz to 2.5 GHz carrier frequency) shall be put
2.3 meters apart from an NL4000 BodyTom system (in order to avoid image
interference risks).
The use of accessories, transducers, and cables other than those specified may result
in degraded ELECTROMAGNETIC COMPATIBILITY of an NL4000 BodyTom system.
The medical staff in charge of this equipment is required to instruct technicians,
patients, and other people who may be around this equipment to comply fully with
the above equipment requirements.

6. Installation Recommendations
This system complies with above mentioned EMC standard when used with supplied
cables.
To minimize interference risks, the following requirements shall apply.
Cable Shielding & Grounding
All interconnect cables to peripheral devices must be shielded and properly grounded.
Use of cables not properly shielded and grounded may result in the equipment causing
radio frequency interference.
Adjacent Components & Equipment
NL4000 BodyTom systems should not be used adjacent to or stacked with other
equipment; if adjacent or stacked use is necessary, an NL4000 BodyTom system
should be tested and verified in order to ensure normal operation in the configuration
in which it will be used. Consult qualified personnel regarding device/system
configurations.
Static Magnetic Field Limits

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To avoid interference on a NL4000 BodyTom system, static magnetic field limits from
the surrounding environment are specified. Static magnetic field is specified less than
<1 Gauss around the unit.
Electrostatic Discharge Environment & Recommendations
o To reduce electrostatic discharge interference, install a charge
dissipative floor material to avoid electrostatic charge buildup.
o The relative humidity shall be at least 30 percent.
o The dissipative material shall be connected to the system ground
reference, if applicable.

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Chapter 8 - Core Safety Guidelines


This chapter provides a variety of safety topics. Please review this material before
using the system and observe basic, common sense rules of safety when operating this
scanner.

1. General Safety Considerations and Statements

Become familiar with the functional hardware, to help can recognize


serious problems
Do not use the scanner if it appears damaged or fails
Wait for qualified personnel to correct the problem

WARNING: Do not remove the covers from the equipment. The covers provide protection
from moving parts or electrical shock from the High Voltage components within the device.

WARNING: Do not remove the covers from the equipment. The covers provide
protection from radiation exposure given off from X-ray Tube.

WARNING: Observe safety requirements to prevent excessive dose exposure to the


patient and/or operator.

CAUTION: Always locate the unit in a well-ventilated area. Keep air pollution to a
minimum. Keep the floor clean at all times.

WARNING: Proper disposal of the batteries are required to ensure compliance to environmental
safety guidelines. Contact the authorized NeuroLogica representative for instructions.

CAUTION: All systems within the patient environment shall provide the same level of
safety as Medical Equipment complying with IEC 60601-1.

WARNING: All non-medical electrical equipment shall comply with relevant IEC and
ISO safety standards.

CAUTION: Do not to touch parts of non-medical electrical equipment in the PATIENT


ENVIRONMENT and the PATIENT simultaneously.

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WARNING: To protect against electric shock, check all external AC cables (device itself
and accompanying equipment) to verify there are no exposed wires/damaged insulation.

CAUTION: After installation, should a subsequent modification be made, it is the


users responsibility to make sure that the system is in compliance with applicable
safety standards.

WARNING: Equipment maintenance of non-medical electrical equipment should not


be performed in the PATIENT ENVIRONMENT.

CAUTION: Do not use the USB terminal located near the EMO switch for connecting
any other device to equipment.

CAUTION: For disposal of any material emanating for the system; follow the local regulations.

CAUTION: For proper disposal of material at the end of the useful life of the
equipment; contact NeuroLogica for proper disposal instructions

2. Cleaning the unit


When the system is between uses, it is recommended to keep it clean as described
below. This will help to remove body fluids to prevent a health risk and damage to
internal parts.
Note: NeuroLogica Corp. recommends a solution of 99% pure Isopropyl
Alcohol (IPA) to sufficiently clean the equipment.

WARNING: Do not spray cleaning agents or spill liquid cleaning agents directly onto
the machine to prevent short-circuiting or possible electrical shock.

WARNING: Always electrically isolate this equipment from the main electrical supply
before cleaning/disinfecting it to prevent short-circuiting or possible electrical shock.

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CAUTION: The unit surfaces may be cleaned with a soft cloth and the recommended
solution or a similar mild non-abrasive cleaning solution. General purpose liquid
disinfectant may also be used as necessary. Apply the cleaning solution to the cloth,
not directly to the unit.

WARNING: Do not use flammable or potentially explosive disinfecting sprays, since


resultant vapor could ignite, causing personal injury and/or damage to the equipment.

3. Maintenance and Service

WARNING: Maintenance checks and all service must be performed by trained


technicians by NeuroLogica Corporation. Please refer to chapter 1 of this document
for NeuroLogica Corp.s contact info. Service personnel utilize the Service Manual
(1-NL4000-062) to effectively perform needed service and preventive
maintenance/inspection on the system.
Note: USERS ARE NOT TO PERFORM SERVICE OR MAINTENANCE ON THE
SYSTEM AT ANY TIME. THIS INCLUDES BATTERY MAINTENANCE.
Note: NeuroLogica Corp recommends a semi-annual service contract.
Note: Service personnel must complete training at NeuroLogica Corp on
the system and its accessories prior to conducting any service activities.
Note: Instructions for replacing serviceable parts are identified in the
Service Manual (1-NL4000-062).
A six month preventive maintenance is recommended to be conducted by (as stated
above) NeuroLogicas service personnel/trained facility bio-engineer

4. Calibration

WARNING: The only needed calibration to be performed by the user on this system is
called a Daily Caibration and is described in detail in Chapter 2 of this document.
All other calibration needs that arise are to be performed by the trained technicians
at NeuroLogica Corporation. Please refer to chapter 1 of this document for
NeuroLogica Corp.s contact info.

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5. Battery Safety and Information

Warning: In case of battery leakage, do not handle the batteries themselves nor
continue to operate the system. Please contact NeuroLogica for service.
1. Battery Protection Mode
The systems battery protection mode causes the system to shut off power to all key
functions when the battery voltage reaches a very low state. This helps protect the
batteries from damage, but may not fully prevent damage from happening. Under
these conditions the unit will appear off. Instructions to recover the system are as
follows:
Plug the system into an operational wall outlet.
Turn on CB1 and the respective AC breaker CB2 or CB3 (depending on Vin).
Check the battery level display.
Wait several hours until the battery capacity has climbed above 25%.
If the steps noted above are have not resolved the issue, then it is likely that the
batteries are damaged. The scanner will require a service technician to replace
the batteries.

CAUTION: Following successful recovery from a battery protection mode event, the
scanner should be plugged in and charging for a minimum of 10 hours.
2. Battery Charging indication
The NL4000 BodyTom battery display reports the state of charge of the batteries.
3. Workstation
The acquisition screen shows an indication of battery capacity, which is identical to
the indicator on the scanner. The user should always check the indicator on the
scanner to verify the status of the batteries.

CAUTION: The workstation will not report the proper battery capacity and status if a
network connection is not made.
4. Battery Replacement/Disposal
The battery system is designed to be replaced by an authorized and trained
NeuroLogica service personnel.

WARNING: Replacement of the batteries shall be performed by authorized technicians


only to ensure proper disposal of hazardous material. For proper disposal of the
batteries contact the authorized NeuroLogica representative for instructions.
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Dispose of in accordance with Federal, State and Local Regulations.


Do not incinerate.
Contact the authorized NeuroLogica representative for instruction for
appropriate product disposal instructions.

6. Emergency Stop

CAUTION: Check all of the EMO switches once a month to ensure proper function.

CAUTION: Every operator should take a few minutes to locate the EMO switches on
the system before he/she scans the first patient.

WARNING: In case of emergencies, gantry movement can be stopped immediately by


pressing any of the EMO switches located on each side of the gantry near the control
panel.
1. Pressing the EMO switch will illuminate and do the following:
Stop the system.
Stop all system motion and X-ray generation.
Note: When Emergency Stop is activated, the moving gantry may overrun
by less than 10 mm. The systems angle is not applicable as it will
remain unchanged.
2. Restoring the System After EMO switch is activated:
Make sure the hazard is removed.
Reset the EMO Switch, by twisting the button itself clockwise until it
retracts.

7. Electrical Safety

WARNING: To prevent electrical shock, servicing is required by qualified service


personnel only.

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WARNING: To prevent electrical shock from the high voltage circuits for generating x
rays, only trained and qualified personnel should be permitted access to the internal
parts of this equipment.

WARNING: Do not to connect items which are not specified as part of the SYSTEM to
prevent electrical shock.

WARNING: Do not remove the covers from the equipment. Hazardous voltages are
present within this equipment. The covers protects from moving parts or electrical shock.

WARNING: The systems AC power cord should be checked to verify there are no
exposed wires or damaged insulation/prongs prior to use. Damaged prongs could
result in sparking and resultantly fire damage.

CAUTION: Periodically check the power cord for evidence of damage (cracks; chips
and dents). In case of such damage replace the power cord immediately with a
hospital/military grade power cord only or use internal power to operate the system.

WARNING: To minimize shock hazard, the system chassis must be connected to an


electrical ground. The system is grounded through the ground conductor of the
supplied, three conductor power cord. The power cord must be plugged into three
conductor electrical outlet receptacle. Do not alter the ground connection.

WARNING:
Avoid all contact with any electrical conductor
Allow only qualified personnel who know the proper procedures to install,
adjust, repair, or modify the equipment
Only use this equipment in rooms or areas that comply with all applicable
regulations concerning electrical safety for this type of equipment
Always electrically isolate this equipment from the main electrical supply
before cleaning/disinfecting it
The detachable cord is the disconnecting device. Mains power can be
removed by disconnecting the power plug from the wall socket

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WARNING: For Class l equipment (e.g. the Workstation Cart, AC Power Cord, etc.)
using an alternate internal source, a warning to use the alternate source if the
integrity of the protective earth conductor is in doubt

CAUTION: The system power cord shall be protected against mechanical damage.

CAUTION: Check to ensure the AC outlet is working properly before plugging in the
systems AC Power Cord.

CAUTION: To prevent damaging electrical outlet cords, check to ensure they have
been removed and properly stored before transporting the scanner.

WARNING: Do not to position the system so that it is difficult to access the AC Power
Cord.

CAUTION: To help prevent tripping hazards, make sure to use care in the
arrangement of any cords (e.g. AC Cord, Ethernet Cable, etc.) when connecting to the
system/workstation.

8. Radiation Safety

Use technique factors prescribed by the radiologist or diagnostician. Use a


dose value that produces the best diagnostic results with the least X-ray
exposure.

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Never perform calibration with patients in the scanner or while personnel


are present in the vicinity of the scanner to prevent exposure to unwanted
radiation.
Amber indicator lights (on the top of the gantry) illuminate during X-ray
exposure.

Note: X-rays can only be produced during the following conditions:


1) When the Scanner is in the Down position
2) The green Start button must be activated on the system itself
3) The Workstation MUST be connected

WARNING: Improperly used X-ray equipment may result in unwanted radiation


exposure. Read and understand the instructions in this document before attempting
to operate this equipment.

CAUTION: The use of this device requires its operators to receive proper training in
accordance with local and national laws.

WARNING: Everyone having anything to do with X-ray must take adequate steps to
ensure protection against injury.

CAUTION: All persons authorized to use the equipment must understand the dangers
posed by excessive X-ray exposure. NeuroLogica Corporation recommends the use of
protective materials when necessary.

9. Mechanical Safety

CAUTION: Prevent pinching or crushing of the patients extremities. Keep the


patients hands on the side of his/her body. Watch the patient and equipment
carefully at all times during gantry movement.

CAUTION: To prevent pinching or crushing of the operators foot/toes, be sure said


extremities are not positioned under the scanner when it is being lowered from
Transport mode to Scan mode.

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WARNING: in case of unwanted movement or motion, press one of the EMO switches
on the gantry to prevent potential patient injury.
Physically assist all patients on and off the scanning platform, and into
position on the scanning platform.
Adjust the scanning platform to the specified height for patient loading and
unloading (see patient set up).
When positioning the scanning platform, be careful when moving the
patient support, to avoid having it hit the gantry covers.
Position any lines (IVs, etc.) attached to the patient so they cannot catch on
the scanner gantry during gantry travel.

10.

Laser Safety

CAUTION: Class 1M Laser radiation when open. Do NOT view directly with optical
instruments.

CAUTION: Use of controls or adjustments or performance of procedures other than


those specified herein may result in hazardous radiation exposure.

WARNING: Viewing the laser output with certain optical instruments (for example eye
loupes, magnifiers and microscopes) within a distance of 100 mm may pose an eye
hazard.

CAUTION: Tell patients to close his/her eyes before switching ON the alignment lasers
to prevent patient discomfort from the Class 1M Laser until deactivating (OFF).
Closely monitor infants and infirm patients, and prevent them from
accidentally staring into the beam.
The following warning label is located on the front of the Gantry cover and
also on inside the Gantry to identify the presence of a laser:

There are 4 lasers used with the BodyTom System as indicated in the
following figure. Lasers B, C, and D are fixed. Laser A, is mounted
internally to the Disk Assembly, which spins (as prescribed and directed by
the Control Panel), within the systems bore. Therefore the lasers output
light will always be aimed at and rotating within the bore itself.

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Laser parameters:
o Lasers A, C, and D:
Wavelength = 650nm
Output Power = 2mW
o Laser B
Wavelength = 650nm
Output Power = 4mW

Figure 119: Laser Apertures Direction

CAUTION: The system should be plugged in at all times when not in transport or
scanning use. Failure to do so could result in permanent battery damage which will
require a service technician to repair.

CAUTION: The system may not complete a scan when below 25% battery capacity.

CAUTION: If the systems battery capacity is reported to be 0% then permanent


damage to the battery can occur.

CAUTION: The system can only be charged from a correctly rated wall outlet. A rating
plate is located on the side of the system, close to the power cord inlet.

CAUTION: Use only the supplied AC power cords when charging the system.

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11.

Gantry Mobility Safety

CAUTION: To prevent patient entrapment or entanglement with accompanying


equipment, slowly remove the scanner away from the patient by using the Control
Panel switches or Pendant controls while observing said patient.

WARNING: When transporting the system to different locations, a video maneuvering


camera is provided to help the operator in preventing collisions that could result in
personal injury or facility damages.

CAUTION: Do not station or operate the system on an uneven floor. The flatness
requirement is 0.12 (inches) over 10 (feet) or 3 mm over 305cm.
Floor level (Even)
For proper operation the system must be operated on an even level floor:
Carpeting
Do NOT use the system on carpeted or other types of soft or cushioned flooring. Poor
image quality could result due to unevenness of floor.

12.

Considerations when preparing the gantry for use

CAUTION: Check for obstructions before moving and system set up.

CAUTION: Monitor the scanner motion to prevent collision with surrounding


environment and foreign objects.

CAUTION: Press the EMO switch immediately in case of abnormal or unexpected motion.

WARNING: Please verify the scanner is on the centipedes (fully down position) prior
to inserting the patient into the bore.

WARNING: Make sure all extremities are not under the scanner while lowering/raising
the said scanner

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WARNING: In the case of a single Pendant failure, the additional Pendant is available
for applicable use to prevent loss of system functionality.

WARNING: Keep the patient in view at all times. Ensure that the patient can be seen
when near the control panel and the EMO switch. Never leave the patient unattended
while they are in the Gantry.

CAUTION: Check to ensure proper clearance is provided to allow removal of the


patient from the scanner in case of a power failure. This is accomplished by moving
the patients support (after unlocking the wheel-locks) away from the scanner.

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Chapter 9 - System Classification and


Symbols
In accordance with International Safety Standard IEC 60601-1, the NL4000
BodyTom family of CT scanners is classified as Type B Equipment; class I Equipment,
Internally Powered Equipment, and Continuous connection to the supply mains in
standby state and for specified loading.

1. IEC Classification
Type B Equipment provides an adequate degree of protection against shock, in
particular regarding:
Allowable leakage current,
Reliability of the protective earth connection
In accordance with the International Safety Standard IEC 60601-1, the manufacturer is
not responsible for any consequences caused by the unauthorized modification of this
equipment
Earth Leakage Current

WARNING:
EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANAESTHETIC
MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE

WARNING:
EQUIPMENT not suitable for use with Oxygen or Oxygen enriched atmospheres.
The NL4000 BodyTom Computer Tomography Systems comply with class I- Type B
Equipment as defined in IEC 60601-1 standard
Mode of operation: Continuous connection to the supply mains in standby state and
for specified loading conditions.
Table 7: Applicable IEC Symbols

Symbols

Description
Alternating Current

Protective Earth (Ground)

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Symbols

Description
Caution:
Attention, consult ACCOMPANYING
DOCUMENTS
Caution risk of electrical shock

Electrostatic sensitive devices

Type B Equipment

X-ray Source Assembly Emitting

Non-Ionizing radiation
Warning sign :
Radiation of Laser Apparatus
High temperature

Emergency Stop (EMO) switch

Crush Warning

System up

System Down
Temperature limits for packaging
Example: Maintain storage
temperature between -20C and
60C

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Symbols

Description
Keep away from rain
for packaging
Humidity limit for packaging
Foot/Toe Crushing Hazard when
lowing machine
Fuse Usage

Warning, battery charging

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Chapter 10 - Technical Specifications


1. Environmental Specifications

CAUTION: The specified environment must be constantly maintained, weekends,


holidays, and throughout the night.
Table 8: Specified Environment
Operating:
Ambient Temperature
Relative Humidity
Altitude
Storage:
Temperature
Relative Humidity
Transport:
Temperature
Relative Humidity
Floor:
Flatness

15 C to 35 C (59 F to 95 F)
20% to 80% (non-condensing)
0-3010 m (0-10,000 ft.)
-20 C to 60 C (-4 F to 140 F)
20% to 85% (non-condensing)
-20 C to 60 C (-4 F to 140 F)
20% to 85% (non-condensing)
<+/1 0.120 inch (3 mm) per ft.

Table 9: System Operating Parameters & Specifications


120 VAC
240 VAC
Phase
Voltage Range
Circuit Protection

Single
100-120 VAC10%

Single
208-240 VAC 10%

Nominal voltage for the U.S. 120,240

20 Amps
30 Amps
NEMA 5-20R
NEMA 6-30R
Outline of outlet:

Facility Outlet

Frequency
Battery Capacity
Typical Usage
Wiring

50 or 60 Hz
50 or 60Hz
Fully Charged, 12 Hours Typical
110-120 VAC 60 Hz
230-240VAC 50 Hz
125V, 2 Pole, 3 Wire 250V, 2 Pole, 3 Wire
Grounding
Grounding

Main Power Supplys


Apparent Resistance
Heat Dissipation
(When the system is NOT idle)

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0.25
55kW

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Table 10: Battery Operating Parameters


Operating Voltage
480 to 585 VDC
Output Current (Peak)
100 Amps
Table 11: Hazardous Substances Table
Substance/Material
Weight/System
Lead
7.69 kg (17.0 lbs.)
Cadmium
0.036 kg (0.079 lbs.)
Mercury
0 kg (0 lbs.)
Hexavalent Chromium
0 kg (0 lbs.)
Polybrominated biphenyls (PBB)
<0.46 kg (1 lbs.)
Polybrominated diphenyl ethers (PBDE)
<0.46 kg (1 lbs.)
Table 12: Filtration Table
Tube Voltage (kV)
100
120
140
Half Value Layer (Aluminum
6 mm
7 mm
8 mm
equivalent)
Filters consist of 0.0014 [0.036mm] of copper and 0.086 [2.18mm] of
aluminum, along with a variable thickness bowtie filter made out of Teflon.
The X-ray Tubes total filtration of the irremovable layers is 5.7 mm of
Aluminum.

2. Part Numbers and Marking Plates


Table 13: Core System Component Part Number Information
Component
Part Number
Marking Plate Locations
NL4000 Gantry
10-00345-001
Near the main input plug
NL4000 Workstation
40-00157-000
On the back of the Workstation
QA phantom
10-00268-001
In the back of the phantom
Note: The applicable components making up the NL4000 BodyTom CT scanners
are identified with the nameplate statement This product complies with
radiation performance standards, 21 CFR sub-chapter J.

Table 14: Core System Component Dimensions


Component / Mode
Size L x W x H
Weight
252.9cm x 103.1cm x 199.6cm
Scan
99.57 x 40.58 x 78.57
1592.11 kg/
NL4000
3510 lbs.
252.9cm x 103.1cm x 205.7cm
Transport
99.57 x 40.58 x 81.00

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Chapter 11 Quality Assurance & Imaging


1. Image Quality Basics
To assure consistent image quality over the system's lifetime, establish and maintain a
regular Quality Assurance (QA) program.
Scan a known material (usually a phantom) under a prescribed set of conditions.
Compare the results to previous or optimum values.
Repeat these tests on a regular basis to detect changes in image quality
values before the problem becomes visible.
Note: If degradation in image quality is observed, or a change in QA values,
schedule a site visit and let the service person or imaging physicist run more
detailed tests.

Early intervention could prevent a major breakdown.


NL4000 BodyTom Quality Assurance begins with baseline performance data acquired
during system installation, or after the repair or replacement of an X-ray Generator
assembly, collimator, detector, DAS, or Main power circuitry.
Compare subsequent QA results against the baseline.
The baseline images for a visual comparison with the QA checks can be saved, but
the measurement values provide a more objective way to monitor quality.
1. Filtration Accuracy
Values of attenuation equivalent, half-value layer, and quality equivalent filtration
are expressed as a thickness of aluminum at a minimum of 99.9% purity
Attenuation of the items in the X-ray beam should not be higher than 2mm of
equivalent Al

CAUTION: Do not put anything in the X-ray bean that exceeds 2mm of equivalent AL
as it may produce adverse effects to the image.

2. QA Phantom
The phantom measures the following parameters that completely characterize image
quality.
Uniformity
Slice width
Noise
Low contrast resolution
High contrast resolution
Sensitometry (contrast scale)

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1. Uniformity
An ROI is automatically selected in each of five locations in the phantom. One ROI is
at the center. Four outer ROIs are 60 to 70 mm from the center of the phantom and
spaced 90 degrees apart. A mean value is calculated in each ROI. The maximum
difference between the means is calculated. The maximum allowable difference is as
noted in the QA Results Table below.
2. Noise
Noise is measured as the standard deviation of pixel values in a 1 cm ROI at the
center of the phantom. The range is as noted in the QA Results Table below
3. High Contrast Resolution
The method to determine resolution in the axial plane is to measure the modulation
transfer function of the scanner. A planar section of the MTF wire provides a point,
called an impulse. The impulse is blurred by the imaging system, and the
measurement of the blur quantifies the resolution. The blur is quantified by the MTF
amplitude which provides a measure of gain for a given object size in line pairs per
centimeter (lp/cm).
The MTF is measured in two directions, called radial and tangential directions. The
radial direction is along the line that joins the wire to the scanner iso-center. The
tangential direction is perpendicular to the radial direction. The MTF along each
direction produces a curve. The points at which each curves amplitude is 50 % and
10 % of its amplitude at zero lp/cm are reported. The expected results are given
below.
Table 15: Modulation Transfer Function (MTF)
Direction
50 % 10 %
Radial
4.7
7.2
Tangential
4.7
7.2

Figure 120: Radial MTF

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Figure 121: Tangential MTF


4. Slice Width
The method to determine the slice width for axial mode QA is to take an image of the
inclined wire. The scanned section of the inclined wire is a line segment. The scanner
blurs a scanned object in the axial plane as well as in the direction perpendicular to
it. The image of the inclined wire includes both the axial plane blurring (MTF) of the
scanner as well as the blurring in the z-direction. The slice width is determined by
removing the component of in plane blurring, measuring the length of the wire
segment, and by using the known angle of wire inclination. The range is as noted in
the QA Results Table below
5. Low contrast
Low contrast resolution is measured as the difference between the mean CT values in
each half of the low contrast insert.
The low contrast is as noted in the QA Results Table below.
6. CT contrast scale
Contrast scale represents the attenuation scaling of the scanner. The mean CT
numbers of each of the sensitometry objects is calculated and reported. The CT
range is as noted in the QA Results Table below
Table 16: QA Results Table
Low
High Limit
Limit
Slice Width
9
11
Noise
2.1
3.1
Low Contrast Resolution
4
6
Uniformity
0
5
CT of Air
-1010
-970
CT of Teflon
960
1000
CT of Acrylic
95
135

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3. Quality Assurance Tool


1. Automatic QA Testing:
a. Performing a Test with the QA Phantom (Automatically)
Note: If automated QA testing is not available, please follow the
instruction in the manual testing procedure in section 3.2.
b. Please make sure a connection to the scanner is established and the
scanner is in idle.
c. Under the Tools menu, select the Quality Assurance option.

Figure 122: Tools Pull Down Menu


d.
e.
f.
g.
h.

The Quality Assurance window will be displayed on the screen.


Follow the instructions on the screen, and then press Prepare.
The system will begin to prepare the QA protocol.
Press Scan on the system once it is in ready state.
After the system is finished processing the QA image, it should appear in
the Acquired Images tab on the Acquisition screen.
i. The results for the QA Image are also shown.
j. Press the Close button when finished to view the results.
k. The results can be viewed at a later time by viewing them through the
Patient Browser.

2. Manual QA Testing:
The quality assurance tool is used to verify the system is at its optimum performance.
To ensure that the system is at its optimum level, the workstation provides QA tools
to verify the state of the system, using image quality verification
Note: Before beginning the QA protocol; please make sure the QA Phantom is

available. This phantom needs to be placed into the bore before starting this process.
a. Performing a Test with the QA Phantom (Manually).
b. First, run a full daily air calibration on the scanner as described in
Chapter 2.
Note: This can take over 10 minutes and should be accomplished in a place where it
is safe to shoot X-ray and the operator is at a safe distance or shielded.

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c. After the air calibration has successfully completed without issues, the
QA Phantom Test is ready to be performed.
d. Place the QA phantom in the scanner bore as centered as possible. The
phantom should be placed on a radiolucent bed or phantom holder to
accomplish this.

Figure 123: Phantom Holder


e. Position the phantom in the manner shown in the image below. The
drilled air hole should be in the upper left hand side when looking at
the phantom from the patient side (as shown).

Figure 124: Phantom Positioning


f. Turn the Scanner lasers on using the pendant. Align the phantom in the
depth of the bore so that the scan plane laser illuminating through the
red ring window intersects the center of the phantom.
g. Open the BodyTom Clinical application if not there already. Register a
manual entry patient, double click on the patient name field and enter
the text QA Phantom in the first name text field. Click 'Update' then
'Register' to be automatically to the Acquisition Screen.

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Figure 125: Exam Planner Window


h. Click the Protocol button and the Exam Planner window will be displayed
(as shown above).
i. From this screen, the adult patient radial button should be selected by
default, and then select the blue colored dot corresponding to the head
region to see a list of available protocols. Choose any one.
Note: If protocols are not available, select another colored dot region to find an

existing axial protocol or a new protocol may need to be created (refer to the user
manual section on creating protocols).
j. The selected protocol will need to be edited (if necessary) by selecting
the Edit button, opening the Edit Protocol window.

Figure 126: Edit Protocol Window


k. Remove any scout protocols by highlighting the scout series and clicking
remove. Then highlight the only remaining Axial protocol and choose
Edit. Enter the desired changes listed below and press the Update button
at the bottom of the screen to save the information.

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Set the parameters to:


kV = 120
mA = 200
Thickness x Spacing = 10 x 10
Start Position = -5
End Position = 5

Sharpness= Pos. Fossa/Vessel


Resolution = 1 seconds
Window width = 135
Window Center = 35

Figure 127: Edit Series Window


l. Click the Update button on the Edit Protocol window and then click
Begin on the Exam Planner window. Wait for the scanners mode orb to
turn green. Click the Start button on the scanner itself when prompted.
m. When the image appears, Enter a value of 10 (mm) in the grid field to
paste a grid on the image. The grid will project heavy center lines for
both horizontal and vertical centers. Ensure the phantom is centered
within 1 cm both horizontally and vertically. If not, adjust the phantom
and rescan using the previous process. Once the phantom is centered as
desired and the scan is complete, choose Finalize and go to the patient
browser. Select the patient ID and select the single image scan and then
choose Load. View the image and make sure it looks good.
n. Do post reconstructions to essentially zoom into the image making the
phantom fill the screen. Go to the Reconstruction Tab now.

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Figure 128: Reconstruction Window


o. Now select the appropriate QA Phantom scan and highlight the single
series down below. On the right side, choose the Load button. Next
select the FOV button and click the curser in the upper left side of the
phantom image and drag a FOV box to the lower left making sure to
encompass the entire phantom with very little extra space. The user can
later move the FOV box to center until satisfied. Ensure that the FOV is
a minimum of 250 mm square.
The under the Load button, fill in the following:
Sharpness = Pos Fossa/Vessle
Slice thickness/Spacing = 10.0 x 10.0
Window Width = 135
Window Level = 35
p. Choose the Start button and a new image set will be created with the
phantom filling the image.
q. Now go back to the patient browser and find the QA Phantom scans and
select the reconstructed FOV image and double click it to load.
r. Select the ROI tool in the Advanced Viewing tool bar.
s. Use the ROI tools and carefully draw regions of interest in each of the
following areas as indicated in Table below (on ROI Locations) and
associated images. The Rois should be at least 400 mm2 in area and
between 3 to 4 radii from the edge of the phantom.
t. Verify the results fall within the ranges noted in Table 15 above.

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Figure 129: Noise and Uniformity

Figure 130: CT Values and Low Contrast


ROI Properties
Noise &
Uniformity
Low Contrast
Resolution
CT of Air
CT of Teflon

Table 17: ROI Properties/Locations


Locations
Descriptions
North, South, East, West (all 1 ROI
diameter from the edge), and Center. Use
A
NSEW Stdev values for noise. Uniformity is
high value minus low value.
Small ROI in each half cylinder. Draw ROI
B
no greater than 1 mm from sample edge.
Subtract high value from low value.
Black spot on image. Draw ROI no greater
C
than 1 mm from sample edge. Use mean
number for value.
Whitest spot on image. Draw ROI no
D
greater than 1 mm from sample edge. Use
mean number for value.

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ROI Properties
CT of Acrylic

Locations
E

Descriptions
Final spot on image (not as bright white as
teflon). Draw ROI no greater than 1 mm
from sample edge.
Use mean number for value.

u. To do Slice Thickness, begin by drawing a region of interest around one


of the vertical wires (choose the left one; see illustrations). Next,
determine the average CT value using the Min CT value and the Max CT
Value. Place this average value into the Window/Width fields as the
center value and enter a value of 1 for the width.

Figure 131: Center Value Window


(e.g. 125 44
2 84)
v. Enter the respective values and review the new adjusted image.

Figure 132: Center Value Window (Adjusted Image)


w. Next, select the Measurement tool (looks like a mini ruler) and draw a
line from the bottom of each wire to the top by placing the rulers little
circle at the lower point, click once and drag the line up to the top of
the wire and click again. Obtain the average of the results from the
lower and tops points being added, and multiply said result by 0.43 to
yield the slice thickness.
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Figure 133: Center Value Window (Slice Thickness Result)


(e.g. (24.18 + 23.32 2) 0.43 = 10.2 mm for slice thickness

4. Dose
The dose is measured using the standard CTDI head and Body phantoms. The surface
and the center CTDIs were both measured. The weighted CTDI is computed using the
surface and the center CTDIs:
2
1


3
3
The measured values are normalized to the scan current, i.e., the CTDI values are in
mGy/100 mAs. For any given scan protocol the CTDIw can be estimated using the
following equation and the data from Tables 18 and 19:
,

, 100

100.0

The CTDIw can also be computed using the data from Tables 20 and 21 and the
following equation:
,

100.0

120

is the X-ray tube


Where W is the kV relative dose ratio with respect to 120 kV.
current in mA, and is the scanning time in seconds. If the scan kV matches the
measured scan voltage then W is equal to 1.0. For helical scans
is calculated
as:

CTDI
For axial scans

vol

CTDI w
Pitch

is calculated as:

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Examples:
For example, the CTDIw of 2 seconds, 100 kV axial head scan, with 200 mA can be
evaluated as follows using the data from Tables 18 and 19:
200.0
2
100 , 200 , 2
100 , 100
100.0
4
100 , 100

4 14.4 57.6

Using the data from Tables 20 and 21, the CTDIw can be computed as follows:
200.0
2
100 , 200 , 2
0.626
120 , 100
100.0
2.504
120 , 100

2.504 23.0 57.59

The CTDIvol is evaluated as follows:

57.6
1.0

57.6

In another example we will compute the CTDIw of 1 seconds, 120 kV helical abdomen
scan, with 200 mA and a pitch of 0.8. The dose can be evaluated as follows using the
data from Tables 18 and 19:
200.0
120 , 200 , 1
1
120 , 100
100.0
2
120 , 100

2 7.56 15.12

Using the data from Tables 20 and 21, the CTDIw can be computed as follows:
200.0
120 , 200 , 2
1.0
1
120 , 100
100.0
2.0
120 , 100

2.0 7.56 15.12

The CTDIvol is evaluated as follows:

15.12
0.8

18.9

1. Body CTDI phantom:


CTDIw using the CTDI Body Phantom is listed in the following table. The data was
measured using the 32rows collimation with the phantom placed on a phantom holder.
The dose measurements were taken using raw data acquisition in Service mode. It
should be noted that performing the scans in different acquisition modes can cause
slight variations in measured dose.
Table 18: Body CTDIw (mGy/100mAs)
140 kV
120 kV
100 kV
CTDI100 center (C)
6.81
4.54
2.65
CTDI100 surface (S)
14.1
9.84
6.49
CTDIw
11.7
8.07
5.21
NeuroLogica Document # 1-NL4000-060, Rev. 02

80 kV
1.20
3.48
2.72
Page 118 of 148

2. Head CTDI phantom:


The CTDIw using the CTDI Head Phantom is in the following table. The data was
measured using the 8 Rows collimation. The dose measurements were taken using raw
data acquisition in Service mode using the phantom holder.
Table 19: Head CTDIw (mGy/100mAs)
120 kV
100 kV
140 kV
CTDI100 center (C)
34.3
23.6
14.6
CTDI100 surface (S)
38.1
26.7
17.0
CTDIw
36.8
25.7
16.2

80 kV
7.55
9.33
8.74

The normalized CTDI tables are listed below. The CTDI is normalized with
respect to a typical 120kV scan protocol:
Table 20: The normalized CTDI of the body phantom.
CTDI100 center (C)
CTDI100 surface (S)
CTDIw

140 kV
1.50
1.43
1.45

120 kV
1.00
1.00
1.00

100 kV
0.584
0.660
0.646

80 kV
0.264
0.354
0.337

Table 21: The normalized head CTDI.


CTDI100 center (C)
CTDI100 surface (S)
CTDIw

140 kV
1.45
1.43
1.43

120 kV
1.00
1.00
1.00

100 kV
0.619
.637
0.630

80 kV
0.320
0.349
0.340

5. Dose in Air
The dose measurements were taken using raw data acquisition in Service mode.
Table 22: CTDIAIR (mGy/100mAs)
120 kV
100 kV
140 kV
32 Row
31.2
22.5
14.9
8 Row
47.3
33.4
21.9

80 kV
8.56
12.6

The dose is measured using a typical head protocol and a typical abdomen protocols.
The dose in air was also measured for repeatability over 10 scans. The average value
and the standard deviation are noted below:
Table 23: Mean and Standard Deviation of the CTDI air)
8 Rows
32 Rows
Mean
19.3596
13.18493
Standard Deviation
0.058716
0.017831

NeuroLogica Document # 1-NL4000-060, Rev. 02

Page 119 of 148

6. Measurement Accuracies
Note: Actual results on installed units can vary 20% due to machine and
test tolerances.
1. Tube Accuracy
kV
140
120
100
80

Table 24: Tube Accuracy


Tolerance
+/- 5%
+/- 5%
+/- 5%
+/- 5%

2. Noise
The variation in standard deviation may be 10% due to variations between systems.
3. Uniformity
The maximum difference between ROI means in an image is 4 HU. The maximum error
in the CT number of water is 3 HU.
4. High Contrast Resolution
The high contrast resolution phantom is a wire placed at the center of a uniform disk.
The wire provides an impulse function in the axial plane when it is placed parallel to
the scanner gantry axis of rotation. The High Contrast resolution is measured from
the Modulation Transfer Function.
5. Geometric Efficiency in the Z-axis direction:
This is the ratio of the integral of the dose profile integrated over the detector width
in Z divided by the total CTDI100. The geometric efficiency in the respective
collimations is 70%.
6. Allowable Variations
Dose: The maximum variation is 10 %.
The variation in values on the MTF curve may be 10%. These will occur mainly due to
phantom placement errors, measurement inaccuracies and system variations.

NeuroLogica Document # 1-NL4000-060, Rev. 02

Page 120 of 148

7. Scatter Radiation
Reference the following radiation scatter plots identifying proper distances to protect
from radiation exposure. The said scatter plots provide the scattered radiation dose
in Air Kerma per current time product in both Standard and SI units for the nominal
technique of 120kV (Rad/100mAs and Gy/100mAs respectively). This information is
given so the facility Physicist and/or Radiation Safety Officer (RSO) can use these
charts to calculate the exposure with the following formula:


100, 120


100


120

In addition, per IEC 60601-2-44, 3rd Edition, Particular requirements for the basic
safety and essential performance of X-ray equipment for computed tomography, a
scatter plot is provided as Figure 122 and 123 for the maximum techniques settings of
140kV and 300mA (standard and SI units respectively).
This information is specifically intended for the facility Physicist and/or an RSO to
perform a safety and shielding analysis such as described in NCRP 147, Structural
Shielding Design for Medical X-Ray Imaging Facilities.

WARNING: It should be known that exposure to radiation can be harmful, and the
usage of the BodyTom should only be done under the direct supervision of the
facilitys qualified Radiation Safety Officer (RSO) in compliance with site, local, state,
provincial, and national regulations. Only this RSO can perform the calculations
necessary to determine what additional safety precautions are necessary, such as
shielding, personal protections, etc.

NeuroLogica Document # 1-NL4000-060, Rev. 02

Page 121 of 148

Figure 134: Scatter Plot (120kV, 100mA in Rad)


Note: In compliance with IEC 60601-2-44:2009, section 203.11, the above
figure shows the scatter radiation measured at the edge of the gantry in
the tomographic plane is 20% of the scatter radiation measure at the
same distance along the axis of rotation in the horizontal plane.
Note: The black box (located at 0 on the x-axis and -2 on the yaxis) represents an approximate (24 x 24 x 79 in inches or 60 x 60 x 200
in cm) zone of occupancy. The system in scan mode stands at 78.5,
which meets the 79 (200cm) requirement.

NeuroLogica Document # 1-NL4000-060, Rev. 02

Page 122 of 148

Figure 135: Scatter Plot (120kV, 100mA in Gy)

Figure 136: Scatter Plot (140kV, 300mA in Rad)

NeuroLogica Document # 1-NL4000-060, Rev. 02

Page 123 of 148

Figure 137: Scatter Plot (140kV, 300mA in Gy)

NeuroLogica Document # 1-NL4000-060, Rev. 02

Page 124 of 148

Note: The anatomical body phantom was placed on a patient support


inside the gantry to take into account scatter through the patient. The
measurements were made using the following scan protocol: 140kV, 200
mA, 5 sec. The following figures show the measurement points in the
vertical, x-y and perpendicular, y-z planes. Followed by corresponding
tables detailing the resulting data.

A B

20

50

50

26

20

50

A
50

B
50

C
50

Iso
center

50

y
E

10

x
Figure 138: Scatter Measurements (x-y plane)

A
B
C
D
E

Table 25: Scatter Measurements (x-y plane) (Rad/100 mAs)


A
B
C
D
E
12.2
15.3
17.7
18.3
15.7
11.9
14.8
16.4
16.7
16.0
11.4
13.6
11.1
12.9
15.2
9.40
10.4
8.87
9.57
12.4
6.09
6.26
4.09
4.26
7.66

NeuroLogica Document # 1-NL4000-060, Rev. 02

F
12.7
12.6
12.5
10.4
7.66

Page 125 of 148

50

50

50

D
50

E
50

50

A
50

B
50

C
D
y

(D,A)

(D,B)

(E,A)

(E,B)

80

50

30

80

40

40

50

(E,C)

10

z
Figure 139: Scatter Measurements (y-z plane)

A
B
C
D
E

Table 26: Scatter Measurements (y-z plane) (Rad/100 mAs)


A
B
C
D
E
300
676
852
591
870
218
539
2320
2940
1090
137
328
931
1120
461
27.8
1080
2790
2240
765
8.96
844
441
85.3
538

NeuroLogica Document # 1-NL4000-060, Rev. 02

F
437
465
233
282
345

Page 126 of 148

8. Dose Profile
The dose profile was measured for 32 rows by taking a stationary scan with
radiochromic film centered on top of the detector array. The scan protocol was as
follows: 120 kV, 200 mA, 5 sec. After the scan was taken the radiochromic film was
scanned and the profile was extracted. The following figure shows the dose profile
and the detector array.
The geometric efficiency was calculated as the ratio of the detector array to the
FWHM of the dose profile using the following formula:

where
is the number of detector rows,
is the magnification factor, and
direction,
maximum of the profile.

is the width of the detector in the zis the full width at half

Figure 140: Dose Profile for 8 Rows

Figure 141: Dose Profile for 32 Rows

NeuroLogica Document # 1-NL4000-060, Rev. 02

Page 127 of 148

Chapter 12 System Storage, Powering On &


Transporting
CAUTION: When not in use the scanner and workstation should be plugged in at all
times to ensure maximum efficiency.
1. Storage
System should be stored in an area with limited access to prevent
inadvertent damage.
Power down the system and workstation computer when not in use to
prevent power from being drawn from the battery back-up systems.

2. Transport

LOCK
A key lock is
provided to
disable all
buttons. If
the key is in
the lock
position all
gantry
buttons are
disabled

OFF
Pressing off
will power
down the
entire gantry.
During the
shutdown
period the
light will blink
until the task
is complete.

TRANSPORT
Pressing
transport
activate the
transport
mechanism
(Drive bar
and lift
rocker
switch)

ON
Pressing on
will power
up the
computer
system.
During the
shutdown
period the
light will
blink until
the task is
complete.

BATTERY BARS
The battery bars
indicate the level
of charge of the
gantry batteries.
Each bar
represents 10% of
charge. If plugged
into an AC outlet
the last bar will
blink indicating
charging.

LIFT
Pressing the
button and
holding it will
allow the gantry
to be raised or
lowered. Lowering
the gantry to the
ground will allow
scanning. Raising
the gantry up will
allow transport

Figure 142: Control Panel Buttons and Details

CAUTION: To prevent healthcare injuries, the Scanner and Workstation should not be
moved by a single healthcare professional at the same time.

CAUTION: Prior to transporting the Scanner verify that the power cable is unplugged
from the wall to avoid damage to the cord and outlet.

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Page 128 of 148

CAUTION: Prior to transporting the Scanner verify that the Ethernet cable is
unplugged from workstation to avoid damage to the cable and outlet.

CAUTION: Two healthcare professionals are recommended to facilitate movement of


the scanner within the facility. One in front of the scanner to ensure there are no
obstacles and the other to drive.
1. To transport the gantry press the Transport button on the Control Panel.
2. Once the transport button transitions to a solid green light press and hold the
lift button until the gantry is completely raised on its transport wheels.
3. A light will illuminate on the lift button when the gantry is in the up position.
4. To transport, grip the transport bar using two hands.
Note: The transport bar is equipped with a switch commonly called a dead-man

switch. When holding the bar the user must press the dead-man switch at the same
time. The switch is a soft rubber material on the back of the transport bar. Grabbing
the bar and squeezing the switch will allow the system to be transported.
5. Moving the unit:
Pushing forward with both hands using equal pressure will allow the gantry
to move forward.
Pushing harder either with the right hand or left hand steer the gantry
either right or left.
Push with the right hand the gantry will move left and pushing with the left
hand the scanner will move right
To move in reverse pull back on the bar to move the gantry in reverse.
Note: It may be required to perform a three point driving technique when turning

into smaller corridors.

WARNING: If a loss of control is encountered when moving the system, release the
dead man switch to stop ALL movement.

WARNING: When transporting use the camera as a guide to avoid hitting objects.

CAUTION: The gantry is larger than most medical equipment, therefore proper
training and practice is recommended

NeuroLogica Document # 1-NL4000-060, Rev. 02

Page 129 of 148

3. Bumper System:
The gantry transport system is equipped with an active safety bumper system. Each
bumper is electronically controlled to terminate motion in the direction in which the
bumper is activated. If a bumper is pressed due to a collision, the drive system will be
disabled in that direction. All other directions will still be enabled to allow the
operator to reposition the gantry away from the impact area. The activation force
needed to trigger the bumper system is approximately 7 lbf.

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Page 130 of 148

Appendix A
1. Tool Quick Reference Guide
For user convenience, the following tables list the majority of the buttons and tools
used throughout the workstation. An understanding of what each one does will be
helpful in successful use of the workstation. These tables may be used to easily
reference the tools various uses in different areas of the workstation.
Buttons

Button Name

Button Description
Protocol Manager: Add a new protocol from the list.
Patient Browser: Select archive destination for selected
information.
Patient Browser: Generates dose for particular patient.
Patient Registration: Cancel current query. Entries
retrieved prior to cancellation will be displayed in the query
results.
Patient Browser : Cancel import series.
Acquisition: Cancels entire protocol.

Acquisition: Cancels the current scan within a protocol.

Customize: Clear information fields.


Protocol Manager: Close the pop-up window being
displayed.
Store/Print Queue: Close the Store/Print Queue window.
Customize: Close the System or User Configuration window.
Acquisition: Authorizes the scanner to proceed to the next
protocol (if applicable).
Patient Registration: Delete patient(s) from the Stores
Results table.
Patient Browser: Delete selected exam information from
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Page 131 of 148

Button Name

Button Description
the patient browser.
Store/Print Queue: Select and delete either a series to be
stores, or a series that failed to store.
Protocol Manager: Delete a saved protocol.
Customize: Clear a particular saved dose setting to no
longer have a restriction.
Customize: Returns all settings for that particular selection
to the maximum scanner default.
Store/Print Queue: Display explanation of why a series
failed to store.
Customize: Echo the selected server to test the connection.
Acquisition: Adds onto the existing protocol X number of
millimeters.
Protocol Manager: Export protocols to a media device.

Acquisition: Completes examination.


Patient Browser: Import exam information from either PACS
or Media.
Protocol Manager: Import Previously exported BodyTom
protocols into the workstation.
Patient Registration: Manually enter a new patient and
proceed to the Acquisition screen.
Patient Browser : Used to modify series scanned under
wrong patient.
Patient Browser: Combine two different series and review
on the Viewing page.
Patient Browser : Minimize import window.
Patient Browser: Used to modify series scanned under
wrong patient.
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Page 132 of 148

Button Name

Button Description
Customize: Create a new folder.
Store/Print Queue: Temporarily stops the series from being
stored.
Acquisition: Suspends multi-step protocol.

Acquisition: Suspends current scan.


Quality Assurance: Prepare workstation to run a quality
assurance test. (See Chapter 11)
Acquisition: Allows the user to select an existing protocol
for the current study.
Patient Registration: Search the HIS/RIS server for
scheduled patients. Depending on the number of entries,
this could take several minutes.
Patient Registration: Register selected patient, and proceed
to the Acquisition screen.
Patient Browser: Opens Create New Study window and
moves selected patient to Acquisition screen.
Acquisition: The last protocol completed is performed
again.
Viewing: Reverts all images back to the original state.
Customize: Resets information back to default, or clears
information fields.
Store/Print Queue: Continues storing paused series.

Store/Print Queue: Try again to store a failed series.

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Page 133 of 148

Button Name

Button Description
Patient Browser: Open selected exam images in the Viewing
page.
Customize: Save updated information.
Patient Registration: Search queried patient entries for
specific information.
Daily Calibration: Begin Daily Cal. (See Chapter 2)
Acquisition: Initiates any post-reconstructions that were
defined during protocol setup.
Patient Registration: Select patient(s) from the query
results and move them into the Stored Results table.
Customize: Administrations may unlock a user account.
Protocol Manager: Update information on an existing
protocol.
Customize: Update information.
Acquisition: Prompts the application to send the selected
protocol to the scanner and verify that the scanner has the
tube/battery capacity to perform the protocol.
Patient Registration: View selected patient details.
Customize: View information.
Patient Browser: View patient, study, series, or image
information, and used to modify series scanned under wrong
patient.
Protocol Manager: Select either an adult or pediatric
patient and the corresponding list of saved protocols will
become available.

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Page 134 of 148

Button Name

Button Description
Viewing: Cine forwards/backwards through the image set,
and stop.
Patient Registration: Scroll through multiple pages of query
results.
Customize: Use arrow buttons to move the selected item up
or down the list. Press Save to save the order.
Customize: Move selected item up or down the list.

Customize: Move selected item up or down the list.

Protocol Manager: Move a protocol up or down the ordered


list, and save order.

Figure 143: Common Workstation Buttons


Tools

Tool

Tool Description
Basics: System Lock to Prevent Unauthorized Use. (See
Chapter 2)

Scanner and Workstation Status Information: X-ray Status.


(See Chapter 3)

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Page 135 of 148

Tool

Tool Description
Scanner and Workstation Status Information: System State.
(See Chapter 3)

Scanner and Workstation Status Information: System


Position. (See Chapter 3)

Scanner and Workstation Status Information: System


Centipede Status. (See Chapter 3)

Scanner and Workstation Status Information: System


Emergency Stop Status. (See Chapter 3)

Scanner and Workstation Status Information: System Air


Freshness Status. (See Chapter 3)

Scanner and Workstation Status Information: System Tube


Capacity Status. (See Chapter 3)

Scanner and Workstation Status Information: System Battery


State of Charge Status. (See Chapter 3)

Scanner and Workstation Status Information: Workstation


Free Disk Space Status. (See Chapter 3)

Scanner and Workstation Status Information: Cart Battery


State of Charge (if purchased option). (See Chapter 3)

Acquisition, Post Reconstruction, Viewing: Clear Active Tool


Resets tool to default pointer device.

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Page 136 of 148

Tool

Tool Description
Acquisition, Post Reconstruction, Viewing: Windowing Tool
Adjusts width and level of the selected image.

Acquisition, Post Reconstruction, Viewing: Zoom Tool


Magnifies the image.

Acquisition, Post Reconstruction, Viewing: Pan Tool


Adjusts the image in the XY axis.

Acquisition: Show/Hide Scouts Removes scouts from the


Acquisition screen.

Acquisition: Adjust Layout (1X1) or (2X2).


Post Reconstruction: Reset Resets the display to default
view settings.
Acquisition: Finalize Exam - Completes all protocols, builds
Dose SR and Images, and directs user to the Patient Browser
screen.
Acquisition: Scan Region Re-Draw.

Acquisition: Bolus Reference ROI Draws ROI on an artery or


vein to track contrast.
Post Reconstruction: Cancels the current postreconstruction request. All images generated up until Stop
is pressed are stored.
Post Reconstruction: Field of View Adjusts the area of
interest prior to generation of images.

Viewing: Region of Interest (ROI) Defines a circular region


of interest and displays ROI information.

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Page 137 of 148

Tool

Tool Description
Viewing: Linear measurement Draws a line on the image
and displays length information.

Viewing: Arrow- Draws an arrow on the screen, which can


be repositioned.

Viewing: Angle Draws an angle on the image and displays


angle information.

Viewing: Text Allows a user to type in text on the image.

Viewing: Rotate Used in 3D Review, this tool rotates the


image.
Viewing: Performs the most recent action again. The button
will be disabled if the application cannot redo an
application.
Viewing: Removes the most recent action performed on the
image. The application remembers the last five adjustments
made, and the button will be disabled if the application
cannot redo an adjustment.
Viewing: Takes a screen shot of the active image viewport.

Viewing: Capture All- Takes a screen shot of all image


viewports.

Viewing: Reverse Stack Reverses the order in which the


images are displayed.

Viewing: Flip images up or down.

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Page 138 of 148

Tool

Tool Description
Viewing: Flip images right or left.
Figure 144: Common Workstation Tools

NeuroLogica Document # 1-NL4000-060, Rev. 02

Page 139 of 148

Appendix B Error Codes


Table 27: Error Codes
FAULT
_CODE

FAULT_DESCRIPTI
ON

ABORT_EXAM

CAN_DEVICE_DISCO
NNECT_CENT1

CAN_DEVICE_DISCO
NNECT_CENT2

CAN_DEVICE_DISCO
NNECT_ROTATE

CAN_DEVICE_DISCO
NNECT_BIB

CAN_DEVICE_DISCO
NNECT_OIB1

CAN_DEVICE_DISCO
NNECT_OIB2

CAN_DEVICE_DISCO
NNECT_POWER

CAN_DEVICE_DISCO
NNECT_TRANS

CAN_DEVICE_DISCO
NNECT_DCB

Pop-up Description &


Resolution
Exam has been aborted. Please
try again, if problem persists
contact customer service with
code
Error occurred, please power
cycle system, if problem
persists contact customer
service with code
Error occurred, please power
cycle system, if problem
persists contact customer
service with code
System cannot rotate. Please
power cycle system, if problem
persists contact customer
service with code
Error occurred, please power
cycle system, if problem
persists contact customer
service with code
Error occurred, please power
cycle system, if problem
persists contact customer
service with code
Error occurred, please power
cycle system, if problem
persists contact customer
service with code
Error occurred, please power
cycle system, if problem
persists contact customer
service with code
System unable to transport.
Please power cycle system, if
problem persists, in case of
emergency initiate manual
transport procedure, and
contact customer service with
code
Error occurred, please power
cycle system, if problem
persists contact customer
service with code

NeuroLogica Document # 1-NL4000-060, Rev. 02

Cause*
Terminate exam was called
due to operator error.
CAN cable disconnected, or
broken, or un-terminated.
Device not powered up, or
device damaged
CAN cable disconnected, or
broken, or un-terminated.
Device not powered up, or
device damaged
CAN cable disconnected, or
broken, or un-terminated.
Device not powered up, or
device damaged
CAN cable disconnected, or
broken, or un-terminated.
Device not powered up, or
device damaged
CAN cable disconnected, or
broken, or un-terminated.
Device not powered up, or
device damaged
CAN cable disconnected, or
broken, or un-terminated.
Device not powered up, or
device damaged
CAN cable disconnected, or
broken, or un-terminated.
Device not powered up, or
device damaged
CAN cable disconnected, or
broken, or un-terminated.
Device not powered up, or
device damaged
CAN cable disconnected, or
broken, or un-terminated.
Device not powered up, or
device damaged

Page 140 of 148

FAULT
_CODE

FAULT_DESCRIPTI
ON

Pop-up Description &


Resolution
Error occurred, please power
cycle system, if problem
persists contact customer
service with code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code

10

CAN_DEVICE_DISCO
NNECT_HVG

11

HVG_LATCH_ERRO
R_ENABLE

12

HVG_LATCH_ERRO
R_INTERLOCK

13

HVG_LATCH_ERRO
R_110_TIMER

14

HVG_LATCH_ERRO
R_XRT_THERM_SW

15

HVG_LATCH_ERRO
R_HE_FLOW_SW

16

HVG_LATCH_ERRO
R_WDT

17

HVG_LATCH_ERRO
R_ARC_FAULT

18

HVG_LATCH_ERRO
R_HVG_FAULT

19

HVG_LATCH_ERRO
R_STARTER

20

HVG_LATCH_ERRO
R_DAS_OVER_RANG
E

High voltage failure, retry


protocol, if problem persists
contact customer service with
code

DAS cabling or converter


card HW issue (perform a
raw offset scan and view
detector data to determine
faulty module)

21

HVG_ERROR_MA_R
EGULATION

High voltage failure, retry


protocol, if problem persists
contact customer service with
code

Internal generator error

NeuroLogica Document # 1-NL4000-060, Rev. 02

Cause*
CAN cable disconnected, or
broken, or un-terminated.
Device not powered up, or
device damaged
Internal generator error

Interlock from somewhere


else in the system
Software error, DCB FW
error
Tube hot - is anode
rotating? HE on?
HW error with heat
exchanger?

DCB HW issue

Tube degraded or not


warmed up
Communication to HVG is
down

Anode HW problem

Page 141 of 148

FAULT
_CODE

FAULT_DESCRIPTI
ON

22

HVG_ERROR_KV_RE
GULATION

23

HVG_ERROR_ANOD
E_STARTER

24

HVG_ERROR_INV_O
VER_TEMP

25

HVG_ERROR_UNCO
MMANDED_EXP

26

HVG_ERROR_ANOD
E_OVER_VOLTAGE

27

HVG_ERROR_CATH
ODE_OVER_VOLTA
GE

28

HVG_ERROR_ANOD
E_OVER_CURRENT

29

HVG_ERROR_CATH
ODE_OVER_CURREN
T

30

HVG_ERROR_FILAM
ENT_OVER_CURREN
T

31

HVG_ERROR_ARC_D
ETECTED

32

HVG_ERROR_CURR
ENT_RET_WIRE_DIS
CON

33

HVG_ERROR_MA_O
VER_PROG

Pop-up Description &


Resolution
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code

NeuroLogica Document # 1-NL4000-060, Rev. 02

Cause*
Internal generator error

Anode HW problem

Internal generator error

Internal generator error

Internal generator error

Internal generator error

Internal generator error

Internal generator error

Internal generator error

Tube degraded or not


warmed up

Internal generator error

Internal generator error

Page 142 of 148

FAULT
_CODE

FAULT_DESCRIPTI
ON

34

HVG_ERROR_KV_O
VER_PROG

35

HVG_ERROR_FILAM
ENT_REGULATION

50

RECON_DATA_COR
RUPTED

51

RECON_OFFSET_CA
L_FAILED

52

RECON_AIR_CAL_F
AILED

53

RECON_OFFSET_CA
L_TIMEOUT

54

RECON_OFFSET_PR
OTOCOL_TIMEOUT

55

RECON_PROTOCOL
_TIMEOUT

56

RECON_PROTOCOL
_REJECTED

57

RECON_POST_NO_S
CAN_INFO

Pop-up Description &


Resolution
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
High voltage failure, retry
protocol, if problem persists
contact customer service with
code
System has encountered an
unexpected error. Please
contact customer service with
code
System failed to properly
perform protocol calibration.
Please try again. If problem
persists, please contact
customer service with code
System failed to properly
calibration system. Please try
calibration again. If problem
persists, please contact
customer service with code
System failed to properly
perform protocol calibration.
Please try again. If problem
persists, please contact
customer service with code
System failed to properly
perform protocol calibration.
Please try again. If problem
persists, please contact
customer service with code
System is unable to perform
protocol. Please try again. If
problem persists, please
contact customer service with
code
System is unable to perform
protocol. Please try again. If
problem persists, please
contact customer service with
code
System is unable to perform
post reconstruction. Please try
again. If problem persists,
please contact customer service
with code

NeuroLogica Document # 1-NL4000-060, Rev. 02

Cause*
Internal generator error

Internal generator error


DMA data stream
interrupted (try again).
Fiber cable or
communication board issue
Bad detector data

Bad detector data or an


object in the bore

Not all views received (DCB,


fiber cable or
communication board issue)

SW error
Recon did not send end of
exam or WS did not send
ImageSeriesComplete. WS
disconnected from scanner;
or view data issue
Parameters out of range.
Recon config files
corrupted/incorrect
Recon app did not complete
the scan. Series directory
was deleted or renamed

Page 143 of 148

FAULT
_CODE

FAULT_DESCRIPTI
ON

58

RECON_POST_RECO
N_FAILED

60

PREPARE_FAILED

61

DISK_PREPARE_ERR
OR

62

CENTIPEDE_MOVE_
TIMEOUT

63

ANODE_STARTUP_T
IMEOUT

64

DISK_NOT_IN_TICK
_MODE

65

COLLIMATOR_POSIT
ION_TIMEOUT

Pop-up Description &


Resolution
System is unable to perform
post reconstruction. Please try
again. If problem persists,
please contact customer service
with code
System failed to properly
prepare protocol. Please try
again. If problem persists,
please contact customer service
with code
System has encountered an
unexpected error. Please try
again. If problem persist,
please contact customer service
with code
The scanner failed to move to
the correct location. Please
check for obstructions or debris
on the floor that could impede
the movement and try again.
Error occurred, please contact
customer service with code
System not rotating at correct
velocity, retry protocol. If
problem persists, contact
customer service with code
Failure to position x-ray beam,
retry protocol, if problem
persists contact customer
service with code
System has encountered an
unexpected error. Please try
again. If problem persist,
please contact customer service
with code
System has encountered an
unexpected error. Please try
again. If problem persist,
please contact customer service
with code

Cause*
Scanner is in scan or fault
state
Scanner control was unable
to perform all the functions
required during prepare.
Could be scanner state,
anode, offset, or rotation
failure
Parameters out of range, or
internal SW error

Centipedes not moving due


to HW issue; centipede jam

Anode/tube HW issue
Incorrect rotation speed
(possible rotate drive
failure)
Collimator HW issue
NOTE that new DCB FW (as
of Aug 2012), is NOT
compatible with pre-1.4
scanner software, and will
cause this error

66

DCB_READY_TIMEO
UT

67

HEAT_EXCHANGER_
ERROR

68

FILAMENT_ERROR

Cannot initiate x-ray, please


contact customer service with
code

Possible bad x-ray tube

SERIAL_LINK_NOT_
UP

System cannot perform protocol


at this time. Please try again. If
problem persists, please
contact customer service with
code

Unknown cause - possibly


slip ring noise (retry scan,
this is a fairly common
intermittent issue). Fiber
cable or comm. card

69

NeuroLogica Document # 1-NL4000-060, Rev. 02

Possible heat exchanger HW


issue

Page 144 of 148

FAULT
_CODE

FAULT_DESCRIPTI
ON

70

ROTATE_COMMAND
_FAILED

Pop-up Description &


Resolution
System failed to properly
rotate. Please retry protocol. If
problem persists, please power
cycle system. If neither step
resolves the problem, please
contact customer service with
code

71

TRANSLATE_COMM
AND_FAILED

System is unable to translate.


Please power cycle, if problem
persists please contact
customer service with code

72

COULD_NOT_START
_SSP

Software startup failure


occurred, please power cycle,
if problem persists contact
customer service with code

73

ROTATE_TO_ANGLE
_FAILED

74

COULD_NOT_CLEAR
_ROTATE_FAULT

75

ENCODER_CONSIST
ENCY_FAULT

80

DISK_SPACE_LOW

81

DISK_SPACE_QUERY
_FAILED

82

NOT_ALL_BASE_DE
VICES_PRESENT

System failed to properly


rotate. Please retry protocol. If
problem persists, please power
cycle system. If neither step
resolves the problem, please
contact customer service with
code
System cannot rotate. Please
power cycle system, if problem
persists contact customer
service with code
[Placeholder]
System disk space low, please
contact customer service with
code
System disk space low, please
contact customer service with
code
Please power cycle system, if
problem persists please contact
customer service with code

NeuroLogica Document # 1-NL4000-060, Rev. 02

Cause*

Rotate command is not


being received

A previous move operation


did not finish ("Trajectory
still in use" reported by CML
library). Bad centipede cal;
centipede config or HW
issue
Scanner control could not
load SSP dll (check to make
sure file
"neurologica.ssp.dll" exists
in scanner bin directory;
and check that it is the
proper date/revision)

Homing sensor not properly


aligned

Rotate device is in bad


state: Restart scanner
(power cycle)
N/A
Insufficient memory space
available
Insufficient memory space
available
CAN cable disconnected, or
broken, or un-terminated.
Device not powered up, or
device damaged

Page 145 of 148

FAULT
_CODE

FAULT_DESCRIPTI
ON

Pop-up Description &


Resolution

Cause*

83

NOT_ALL_DISK_DEV
ICES_PRESENT

Please power cycle system, if


problem persists please contact
customer service with code

CAN cable disconnected, or


broken, or un-terminated.
Device not powered up, or
device damaged

90

CCB_BATTERY_OPE
RATIONAL

System has encountered an


unexpected error. Please
contact customer service with
code

Battery system error


CCB_BATTERY_INTERLOCK is
the signal from the battery
trays of health status. If
that signal disappears,
something in the battery
trays or the interconnect
has gone wrong. Battery
management is most
certainly offline at this
point so service will need to
be called and further
scanning is not
recommended.
Breaker was turned off (turn
it on!)

91

CCB_BATTERY_INT
ERLOCK

System has encountered an


unexpected error. Please
contact customer service with
code

92

CCB_BATTERY_MAI
N_BREAKER

Circuit breaker has been


tripped, please reset and
contact customer service with
code

CCB_LOW_BATTER
Y_ALARM

Low battery condition, please


charge system as soon as
possible.

94

CCB_DEAD_BATTER
Y_ALARM

Dead battery condition, the


system is shutting down. Please
charge system and report
condition to customer service
with code

95

CCB_HIGH_BATTER
Y_ALARM

High battery condition has


occurred. Battery charging has
been disabled.

96

CCB_OVERCGARGE
D_BATTERY_ALARM

Please power down and unplug


system and contact customer
service immediately with code

93

NeuroLogica Document # 1-NL4000-060, Rev. 02

Charge the batteries or we


will eventually get to Dead
Battery condition and shut
down the scanner
Scanner not plugged in or
wall breaker is off. Starting
up scanner from a very low
capacity, this may happen a
few times before capacity is
high enough for a full
power-up.. Battery system
or connection failure.
This is normal and scanning
is possible (this error should
NEVER be displayed to the
user, only logged in the
scanner log)
Battery system error

Page 146 of 148

FAULT
_CODE

FAULT_DESCRIPTI
ON

97

CCB_BATTERY_HIG
H_TEMP_ALARM

98

CCB_BATTERY_OVE
R_TEMP_ALARM

99

CCB_BATTERY_MEA
SUREMENT_ERROR

Pop-up Description &


Resolution
High temperature battery
condition, contact customer
service if condition persists
with code
Over temperature battery
condition, please power down
and unplug system and contact
customer service immediately
with code
System has encountered an
unexpected error. Please
contact customer service with
code

Cause*
Battery system error

Battery system error

Battery system error

*There may be multiple causes that require a trained service technician to conduct an
analysis and repair

NeuroLogica Document # 1-NL4000-060, Rev. 02

Page 147 of 148

Revision History
Revision

ECO #

00

ECO001673

01

ECO001877

02

ECO002003

Table 28: Revision History Table


Author
Changes
Christofer
Krueger/Mike
New Release
Limoli/Ibrahim
Bechwati
Correct minor edits uncovered during
Christofer
translations review and pilot installations.
Krueger
Also needed to add 3rd edition and HC
requirements
Update to meet IEC 60601-1 3rd ed, 60825Christofer
1, and CFDA Requirements. Error codes,
Krueger
addl warnings, focal spot, CTDI100 results,
scatter values, product label location, etc.

NeuroLogica Document # 1-NL4000-060, Rev. 02

Page 148 of 148

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