nl 4000 user manual

BodyTom is a registered trademark of NeuroLogica Corporation

NL4000 BODYTOM USER MANUAL 1-NL4000-060 REVISION 02

NeuroLogica Document # 1-NL4000-060, Rev. 02 Page 2 of 148

Table of Contents Contents Table of Contents .................................................................................. 2

Contents .......................................................................................... 2Figures ............................................................................................. 5Tables ............................................................................................. 8

Contact Information ............................................................................... 9DAMAGE IN TRANSPORTATION .................................................................... 9Chapter 1 - Getting Started ..................................................................... 10

1. Intended Use ............................................................................. 102. Personnel Privileges & Terminology: ................................................. 103. NL4000 BodyTom Typical Configuration ............................................ 114. Use of Manual ............................................................................ 115. Safety Classification Symbols and System Help .................................... 116. System Equipment Safety Warning Designations ................................... 127. Cautionary Information ................................................................. 128. NeuroLogica Contact Help ............................................................. 14

Chapter 2 - The Workstation Getting Started ................................................ 151. Location of the Workstation ........................................................... 152. Logging In and Out of the Workstation .............................................. 163. Shutting Down the Workstation ....................................................... 164. Main Menu ................................................................................ 175. About The Workstation ................................................................. 196. General Scanner Operation Information ............................................. 19

Chapter 3 - Workstation Configuration and Setup ........................................... 211. The Basics ................................................................................ 212. Focal Spot ................................................................................ 213. Source to Detector Distance (SID) .................................................... 214. Anode Input Power ...................................................................... 215. Protocol Manager ........................................................................ 226. Load Factors ............................................................................. 227. Add New / Update Protocol ........................................................... 238. Delete a Protocol ........................................................................ 289. Change Protocol Order ................................................................. 2810. Import Protocols ......................................................................... 2811. Export Protocols ......................................................................... 2912. Customize Menu Bar .................................................................... 2913. General Settings ......................................................................... 3014. User Accounts ............................................................................ 3115. Manage Users ............................................................................ 3116. Save User ................................................................................. 3117. Update User .............................................................................. 3218. Delete User ............................................................................... 3219. Modify User Order ....................................................................... 3220. Unlock User .............................................................................. 3221. DICOM Servers ........................................................................... 32


22. Manage Servers .......................................................................... 3323. Save a Server ............................................................................. 3324. Update a Server ......................................................................... 3425. Delete a Server .......................................................................... 3426. Echo Server ............................................................................... 3427. Modify Server Order ..................................................................... 3428. DICOM Settings ........................................................................... 3529. Dose Configuration ...................................................................... 3530. Windowing Presets ...................................................................... 3731. Update Account ......................................................................... 3732. Column Settings ......................................................................... 3733. Scan Dosage Report ..................................................................... 38

Chapter 4 - Scanning Basics ..................................................................... 391. Contraindication(s) ..................................................................... 392. Physical Setup, Patient, and Scanner Positioning .................................. 393. Patient Support/Bed .................................................................... 404. Pendant Control ......................................................................... 415. Scanning .................................................................................. 44

Chapter 5 - Workstation Scanning .............................................................. 481. The Basics ................................................................................ 482. Patient Registration ..................................................................... 483. Perform Query Steps .................................................................... 504. Create a Stored List ..................................................................... 505. Delete a Stored Procedure ............................................................. 506. Manually Register a Patient ........................................................... 507. Acquisition ................................................................................ 518. Perform Acquisition Steps ............................................................. 559. Perform a Reference Scan ............................................................. 5810. Screen Setup ............................................................................. 5811. Post Reconstruction ..................................................................... 6112. Perform Post Reconstruction Steps ................................................... 6313. Finalize Exam ............................................................................ 63

Chapter 6 Patient Browser and Viewing ..................................................... 641. The Basics ................................................................................ 642. Patient Browser ......................................................................... 643. Archive to PACS .......................................................................... 684. Print ....................................................................................... 695. Delete Series ............................................................................. 696. Lock Series ............................................................................... 707. Mark Series ............................................................................... 708. Merge Series .............................................................................. 709. Register Patient ......................................................................... 7110. Load Series into Viewing ............................................................... 7111. View/Update Series ..................................................................... 7112. Modify Series Scanned Under Wrong Patient ....................................... 7213. View/Update QA Series ................................................................ 7314. Import Series ............................................................................. 7315. Viewing ................................................................................... 74


16. Save Preset ............................................................................... 7917. Delete Preset ............................................................................ 8018. Change Layout ........................................................................... 80

Chapter 7 - Compliance Requirements ........................................................ 811. Group 1 Class A Medical Devices ...................................................... 812. Compliance Statement ................................................................. 823. EMI/EMC Glossary Terms ............................................................... 824. Countermeasures against EMC related issues ....................................... 865. Use Recommendations ................................................................. 886. Installation Recommendations ........................................................ 88

Chapter 8 - Core Safety Guidelines ............................................................. 901. General Safety Considerations and Statements .................................... 902. Cleaning the unit ........................................................................ 913. Maintenance and Service ............................................................... 924. Calibration ............................................................................... 925. Battery Safety and Information ....................................................... 936. Emergency Stop ......................................................................... 947. Electrical Safety ......................................................................... 948. Radiation Safety ......................................................................... 969. Mechanical Safety ....................................................................... 9710. Laser Safety .............................................................................. 9811. Gantry Mobility Safety ................................................................ 10012. Considerations when preparing the gantry for use .............................. 100

Chapter 9 - System Classification and Symbols ............................................. 1021. IEC Classification ...................................................................... 102

Chapter 10 - Technical Specifications ....................................................... 1051. Environmental Specifications ....................................................... 1052. Part Numbers and Marking Plates .................................................. 106

Chapter 11 Quality Assurance & Imaging ................................................... 1071. Image Quality Basics .................................................................. 1072. QA Phantom ............................................................................ 1073. Quality Assurance Tool ............................................................... 1104. Dose ..................................................................................... 1175. Dose in Air .............................................................................. 1196. Measurement Accuracies ............................................................. 1207. Scatter Radiation ...................................................................... 1218. Dose Profile ............................................................................ 127

Chapter 12 System Storage, Powering On & Transporting .............................. 1281. Storage .................................................................................. 1282. Transport ............................................................................... 1283. Bumper System: ....................................................................... 130

Appendix A ....................................................................................... 1311. Tool Quick Reference Guide ......................................................... 131

Appendix B Error Codes....................................................................... 140Revision History .................................................................................. 148


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


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


Figure 96: Move Series Window ................................................................. 72Figure 97: Import Button (PT Browser) ........................................................ 73Figure 98: Import Location Window ............................................................ 73Figure 99: Import Button (PT Browser) ........................................................ 74Figure 100: Minimize Button (PT Browser) .................................................... 74Figure 101: Cancel Button (Import Location Window) ...................................... 74Figure 102: 2D View Screen ...................................................................... 74Figure 103: MPR View Screen .................................................................... 75Figure 104: 3D View Screen ...................................................................... 75Figure 105: 3D Tools Screen (Left) ............................................................. 75Figure 106: MPR Tools Screen (Center) ........................................................ 75Figure 107: 2D Tools Screen (Right) ............................................................ 75Figure 108: View Screens Tool Buttons ........................................................ 77Figure 109: Windowing (View Screens Tools ~ Close-up) ................................... 77Figure 110: Layout (View Screens Tools ~ Close-up) ........................................ 77Figure 111: Zoom (View Screens Tools ~ Close-up) .......................................... 77Figure 112: Rotate (View Screens Tools ~ Close-up) ........................................ 78Figure 113: Positioning (View Screens Tools ~ Close-up) ................................... 78Figure 114: Positioning Buttons (View Screens Tools ~ Close-up) ......................... 78Figure 115: Compare (View Screens Tools ~ Close-up) ...................................... 79Figure 116: Positioning (3D View Screen Tools ~ Close-up) ................................ 79Figure 117: Rendering (3D View Screen Tools ~ Close-up) ................................. 79Figure 118: Orientation (3D View Screen Tools ~ Close-up) ................................ 79Figure 119: Laser Apertures Direction ........................................................ 99Figure 120: Radial MTF ......................................................................... 108Figure 121: Tangential MTF .................................................................... 109Figure 122: Tools Pull Down Menu ......................................................... 110Figure 123: Phantom Holder ................................................................... 111Figure 124: Phantom Positioning ............................................................. 111Figure 125: Exam Planner Window ........................................................... 112Figure 126: Edit Protocol Window ............................................................ 112Figure 127: Edit Series Window ............................................................... 113Figure 128: Reconstruction Window .......................................................... 114Figure 129: Noise and Uniformity ............................................................. 115Figure 130: CT Values and Low Contrast .................................................... 115Figure 131: Center Value Window ............................................................ 116Figure 132: Center Value Window (Adjusted Image) ...................................... 116Figure 133: Center Value Window (Slice Thickness Result) .............................. 117Figure 134: Scatter Plot (120kV, 100mA in Rad) .......................................... 122Figure 135: Scatter Plot (120kV, 100mA in Gy) ........................................... 123Figure 136: Scatter Plot (140kV, 300mA in Rad) .......................................... 123Figure 137: Scatter Plot (140kV, 300mA in Gy) ........................................... 124Figure 138: Scatter Measurements (x-y plane) ............................................. 125Figure 139: Scatter Measurements (y-z plane) ............................................. 126Figure 140: Dose Profile for 8 Rows .......................................................... 127Figure 141: Dose Profile for 32 Rows ......................................................... 127Figure 142: Control Panel Buttons and Details ............................................. 128Figure 143: Common Workstation Buttons .................................................. 135


Figure 144: Common Workstation Tools ..................................................... 139

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


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.

EU Rep Winckels Medical Devices Expertise Europe Bergerweg 18 6085 AT Horn Holland +31 (0)475 582285 Tel +31 (0)475 582278 Fax +31 (0)6 532 530 76 Mobile http://www.wmdegroup.com

Australian Sponsor LifeHealthCare 15 Talavera Road North Ryde NSW 2113 Australia Attn: Daren McKennay +61 (0) 2 8114 1503 [email protected]


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


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.


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 facil ity.


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).


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 NeuroLogica Corporation Company Department Customer Service

Address 14 Electronics Avenue Danvers, MA 01923 USA

Technical Support US & Canada 1-888-564-8561 International 1-978-564-8561

E-mail Address [email protected]


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')

1.5m (4.92') 1.5m (4.92')

2.5m (8.20')

Figure 2: WorkStation Safe Distance Location (2 views)


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 re-

enter 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.


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.


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)


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.


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 stil l be transported in this mode, but extra caution must be observed during transport.


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)


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 kV mA

Time (seconds)

Axial 80-140 50-300 1 Helical 80-140 50-300 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.


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

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.

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.


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


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


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:


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.


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 modify the order in which the protocols appear in the system: 1. Select a protocol type. 2. Select a protocol. 3. Press Up arrow button to move the protocol up the list. 4. Press the Down arrow button to move the protocol down the list. 5. 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.


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.


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


The following information may be adjusted by the user using the General Settings window:

Scanner IP Address Scanner Control Software port Reconstruction Software port Remote Support Setup Options for Advanced 2D

Viewing Orientation Change Password Interval HIS/RIS and PACS Network

Connection Institution Information

System Station AE Title Options to

o Automatically Show Store/Print Queue

o Auto Store/Print o Show Dose Report o Show Stored Query

Results o Auto Lock

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. Enter User ID. 2. Enter User Level. 3. Enter Last Name. 4. Enter First Name.

5. Enter Password. 6. Verify Password. 7. Press Save. 8. User is added to list.

BodyTom is a registered trademark of NeuroLogica Corporation

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


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.


3. Enter a Server AE Title. 4. Enter Server IP Address. 5. Enter Server Port. 6. Enter Connection Timeout. 7. Enter Device AE Title. 8. 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. Select a server type. 2. Select a server from the list. 3. Modify parameters. 4. Press Update. 5. 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. Select a server type. 2. Select a server. 3. Press Echo. 4. Status of server should appear.

27. Modify Server Order 1. Select a server type. 2. Select a server. 3. Press the Up arrow button to move the server up in the list. 4. Press the Down arrow button to move the server down in the list. 5. Press the Save button to save the server order.


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


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 l imit of 1 Gy CTDI.


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)


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.


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.


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.


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:


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.


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


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


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.


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


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)


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


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


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


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.


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)


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.


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.


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.

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


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

nl 4000 user manual

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