Professional Documents
Culture Documents
1-NL4000-060 REVISION 02
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
NeuroLogica Document # 1-NL4000-060, Rev. 02
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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
NeuroLogica Document # 1-NL4000-060, Rev. 02
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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
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1. Intended Use
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The NL4000 BodyTom Core system consists of the scanner and the Workstation.
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.
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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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.
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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.
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: 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: 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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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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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.
1.5m (4.92')
2.5m (8.20')
1.5m (4.92')
1.5m (4.92')
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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.
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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
3. Customize
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4. Help
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7. About
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2. Daily Calibration
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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.
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5. Protocol Manager
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.
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6. Select a protocol series. User may choose from the default list, or add/update
a protocol.
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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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.
10.
Import Protocols
1. Open the Protocol Manager and press the Import button. The select file window
will be displayed.
NeuroLogica Document # 1-NL4000-060, Rev. 02
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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.
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Update information.
View information.
13.
General Settings
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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.
5.
6.
7.
8.
Enter Password.
Verify Password.
Press Save.
User is added to list.
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3.
4.
5.
6.
7.
8.
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2. Patient Browser
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1. Contraindication(s)
There are no contraindications associated with Computed Tomography X-ray scanning
Note : For any devices connected to an AC outlet, make sure the outlet itself
is providing the required power.
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.
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: 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.
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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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: 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).
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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.
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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.
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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.
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1. The Basics
The workstation is broken up into five major sections, each represented by a tab on
the main application screen.
2. Patient Registration
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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.
Select patient(s) from the query results and move them into the
Stored Results table.
Delete patient(s) from the Stored Results table.
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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.
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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Displays the power settings and patient dose information for the current scan.
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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.
NeuroLogica Document # 1-NL4000-060, Rev. 02
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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.
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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.
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Blue = Idle
Green = 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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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
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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.
Patient Browser Gives access to all of the series stored on the workstation.
Viewing Advanced Image Analysis Tool.
2. Patient Browser
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The screen is where the results from the query are displayed and particular tasks are
presented:
Buttons
Select archive destination for selected information.
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Series Table.
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Store/Print Queue
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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.
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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.
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.
Note: All QA Series are locked to prevent deletion. They cannot be unlocked.
7. Mark Series
1.
2.
3.
4.
5.
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.
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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.
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.
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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.
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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.
15. Viewing
1. 2D Review
2-D allows the images to be viewed in 2-Dimensional space.
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2. MPR Review
MPR review allows the user to view the dataset in 3-Dimensions using three orthogonal views.
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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.
CT Angio 1
CT Angio 2
Trachea
Circle of Willis
Color
Grayscale
MIP
Alters the position in which the images are displayed. User may choose
Inferior
Superior
Anterior
Posterior
Right
Left
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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.
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
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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: 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.
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Radiated RF
IEC 610004-3
(alternative
method: IEC
61000-4-21)
3 Vrms
80 MHz to
2,5 GHz
E1 = 3 V/m
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.
NeuroLogica Document # 1-NL4000-060, Rev. 02
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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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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.
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.
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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: 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
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.
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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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.
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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.
7. Electrical Safety
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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:
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
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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
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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.
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
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: 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.
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.
CAUTION: Check for obstructions before moving and system set up.
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
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.
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
Symbols
Description
Caution:
Attention, consult ACCOMPANYING
DOCUMENTS
Caution risk of electrical shock
Type B Equipment
Non-Ionizing radiation
Warning sign :
Radiation of Laser Apparatus
High temperature
Crush Warning
System up
System Down
Temperature limits for packaging
Example: Maintain storage
temperature between -20C and
60C
Symbols
Description
Keep away from rain
for packaging
Humidity limit for packaging
Foot/Toe Crushing Hazard when
lowing machine
Fuse Usage
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.
Single
100-120 VAC10%
Single
208-240 VAC 10%
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
0.25
55kW
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)
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
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.
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.
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.
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.
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
CTDI
For axial scans
vol
CTDI w
Pitch
is calculated as:
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
80 kV
1.20
3.48
2.72
Page 118 of 148
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
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
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
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.
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.
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
F
12.7
12.6
12.5
10.4
7.66
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
F
437
465
233
282
345
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
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
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.
CAUTION: Prior to transporting the Scanner verify that the Ethernet cable is
unplugged from workstation to avoid damage to the cable and outlet.
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
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
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.
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.
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.
Button Name
Button Description
Customize: Create a new folder.
Store/Print Queue: Temporarily stops the series from being
stored.
Acquisition: Suspends multi-step protocol.
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.
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.
Tool
Tool Description
Basics: System Lock to Prevent Unauthorized Use. (See
Chapter 2)
Tool
Tool Description
Scanner and Workstation Status Information: System State.
(See Chapter 3)
Tool
Tool Description
Acquisition, Post Reconstruction, Viewing: Windowing Tool
Adjusts width and level of the selected image.
Tool
Tool Description
Viewing: Linear measurement Draws a line on the image
and displays length information.
Tool
Tool Description
Viewing: Flip images right or left.
Figure 144: Common Workstation Tools
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
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
FAULT
_CODE
FAULT_DESCRIPTI
ON
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
21
HVG_ERROR_MA_R
EGULATION
Cause*
CAN cable disconnected, or
broken, or un-terminated.
Device not powered up, or
device damaged
Internal generator error
DCB HW issue
Anode HW problem
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
Cause*
Internal generator error
Anode HW problem
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
Cause*
Internal generator error
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
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
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
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
SERIAL_LINK_NOT_
UP
69
FAULT
_CODE
FAULT_DESCRIPTI
ON
70
ROTATE_COMMAND
_FAILED
71
TRANSLATE_COMM
AND_FAILED
72
COULD_NOT_START
_SSP
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
Cause*
FAULT
_CODE
FAULT_DESCRIPTI
ON
Cause*
83
NOT_ALL_DISK_DEV
ICES_PRESENT
90
CCB_BATTERY_OPE
RATIONAL
91
CCB_BATTERY_INT
ERLOCK
92
CCB_BATTERY_MAI
N_BREAKER
CCB_LOW_BATTER
Y_ALARM
94
CCB_DEAD_BATTER
Y_ALARM
95
CCB_HIGH_BATTER
Y_ALARM
96
CCB_OVERCGARGE
D_BATTERY_ALARM
93
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
Cause*
Battery system error
*There may be multiple causes that require a trained service technician to conduct an
analysis and repair
Revision History
Revision
ECO #
00
ECO001673
01
ECO001877
02
ECO002003