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Lunar DXA Imaging Procedure Manual

APPENDICES
SECTION X

TABLE OF CONTENTS
1 Appendix A: Scan Modes ................................................................................. X-2

2 Appendix B: New Database Setup ................................................................... X-4

3 Appendix C: Copying Subject Images to Electronic media ........................... X-5

4 Appendix D: Copying the IQC Database FILE to Electronic Media ............... X-7
4.1 Software versions prior to 15.10, that export phantom database files as .mdb) ... X-7
4.2 Software version 15.10 and any future software versions that generate the
phantom database files using SQL (not as an .mdb file). .................................... X-9
4.3 Software version 15.10 and any future software versions that generate the
phantom database files using SQL (not as an .mdb file) – Alternate option....... X-17
4.4 GE Lunar—Windows – (software versions 10.0 and above) Instructions for copying
QA block ........................................................................................................... X-19
4.5 GE Lunar—Windows – (software versions 10.0 and above) Instructions for copying
QA block – Alternate option .............................................................................. X-24

5 Appendix E: Disabling the Auto-Analysis Feature—GE Lunar ENCORE .... X-26


5.1 Avoiding Analysis after Acquisition of a New DXA Examination ........................ X-26
5.2 Verifying the Status of Analysis ......................................................................... X-27
5.3 Unanalyzing the Analyzed DXA Scan ............................................................... X-28

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1 APPENDIX A: SCAN MODES


Scan mode can have an effect on bone density data. For consistency, use the modes
listed below for the various scanner models. If the image quality appearing while
scanning a subject is not of good quality, stop the scan and check that the scan mode is
appropriate; if necessary, try a different scan mode.
• Use the same scan mode used at baseline at all follow-up visits; a change in scan
mode will require a follow-up scan to be repeated.
• If the machine defaults to a different scan mode, you can select the scan mode
used at baseline before moving the scan arm into position (see image below).

1.1 GE Lunar – Windows


DO NOT USE the “One Scan” feature or positioning method.

Do not check the OneScan


checkbox as seen below.
Do not position the patient
as illustrated to the left.

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Prodigy, Prodigy Advance, iDXA Series

Site Subject Thickness Scan Mode Current (mA)


> 25 cm Thick 3.000
Lumbar Spine 13 – 25 cm Standard 3.000
< 13 cm Thin 0.750
> 25 cm Thick 3.000
Femur 13 – 25 cm Standard 3.000
< 13 cm Thin 0.750
Forearm All Standard 0.150
> 25 cm Thick 0.150
Whole Body 13 – 25 cm Standard 0.150
< 13 cm Thin 0.150

DPX-NT Series
DO NOT USE the Precise and Quick View scan modes.

Site Subject Thickness Scan Mode Current (mA)


> 25 cm Thick 3.000
Lumbar Spine 15 – 25 cm Standard 3.000
< 15 cm Thin 0.750
> 25 cm Thick 3.000
Femur 15 – 25 cm Standard 3.000
< 15 cm Thin 0.750
Forearm All Standard 0.150
> 25 cm Thick 0.150
Whole Body 15 – 25 cm Standard 0.150
< 15 cm Thin 0.150

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2 APPENDIX B: NEW DATABASE SETUP


Below are step-by-step instructions for setting up a new phantom or study database
within specific GE Lunar DXA machine software.

2.1 GE Lunar—Windows
1. From the main menu, select “Directory”.
2. On the left side of the screen under “All Databases”, select New Database”, and
the New Database window will appear.
3. Give the new database a name that reflects the data that will be stored in this
database (example: Phantom or Protocol Number).
4. Check that the Working Folder is correctly indicating where the database will be
stored. Update if necessary.
5. Click OK; the new database has been created.
6. Remember to switch databases before and after phantom spine data is acquired.

Figure 15-1: GE Lunar—Windows New Database Setup Screen

3.

4.

2.

5.

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3 APPENDIX C: COPYING SUBJECT IMAGES TO ELECTRONIC


MEDIA
Below are step-by-step instructions for copying the electronic scan images to electronic
media or desktop location.

3.1 GE Lunar—Windows
1. Starting from the main screen, select Directory
2. Put the electronic media in the drive, or create a location on your desktop (for
writing scans to a CD or submitting data electronically through SMART Portal).

3. Find the subject and the images that will be sent; highlight more than one image by
holding down the Ctrl key.
- Please do not copy more scans per disk than can be clearly entered on
the Bioclinica-provided disk labels.

4. From the menu at the top of the screen select the following (cascading menu):
- Directory
- Send Exam File To
- Disk…

5. A new window will open with two check boxes. Both boxes must be unchecked!

Both
boxes
must be
unchecked

6. Press OK

7. In the next window that opens, select the electronic media drive or desktop location
and follow any remaining prompts.

8. Check the contents of the electronic media:

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a. Double-click on the “My Computer” icon.


b. Double-click on the drive that contains the electronic media on which the data
is saved.
c. If the image file(s) appear, the file copy was successful.

For CDs, use the CD writing software installed on the computer to write the file to a CD.
Ensure that you remove the files from your desktop location when complete, to
avoid sending the same files in future submissions

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4 APPENDIX D: COPYING THE IQC DATABASE FILE TO


ELECTRONIC MEDIA
4.1 GE Lunar— Windows (software versions prior to 15.10, that export
phantom database files as .mdb)

Note: For Lunar Prodigy V15.10 (and any future versions that generate the phantom
database files as SQL rather than .MDB) see Section 4.2
Below are step-by-step instructions for finding and copying the phantom database file
needed for IQC: the lunar.mdb** file.
**Note: Depending on the computer’s configuration of the Windows properties, the file
may appear only as lunar. When locating the lunar.mdb file, if the GE Lunar software
was minimized instead of closed after locating the phantom database, a file called
lunar.ldb may appear - this is the wrong file.

Locate the Phantom Database:


1. At the main menu, select Directory.
2. On the left hand side of the screen, under All Databases, select the location to scan
the phantom database.
3. Just above All Databases is Active Databases. Under Active Databases, is
Working Path: with a file path.

4. Write this file path down on a piece of paper, making sure to copy the name exactly
as it appears: Example: c:\data2\
5. Close the software.

Copy the Phantom Database


1. Insert the media into the drive.
2. From the Windows desktop, open “My Computer”.
3. Find and open the directory containing the phantom database (the location you
wrote down above).

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4. To a disk:
a. Find and select by single-clicking (do not double-click and open) the
lunar.mdb** database file.
b. Right click the lunar.mdb** database file and select the “Send To” cascading
menu from the drop down list.
c. Select the disk drive for the electronic media the file will be copied to.
5. To a CD:
a. Copy the lunar.mdb** file to the computer desktop.
b. Use the CD writing software installed on the computer to write the file to a CD.
c. Be sure to let the CD writing software finish fully and eject the CD.
d. To verify the file has been copied to the CD, put the CD back in the drive,
open the ‘View’ tab, select ‘Refresh’, the file should appear in the window, do
not open the file as this can corrupt the data.

Verify that the disk(s) or CD contain the files:


1. Double-click the “My Computer” icon.
2. Double-click on the drive that contains the media on which the data is saved.
3. Check that the file lunar.mdb** appears, indicating that the database copy routine
was successful.
Ensure that you remove the files from your desktop location when complete, to
avoid sending the same files in future submissions

Ship data to Bioclinica


1. Remove the electronic media and label it with the IQC electronic media label.
2. Send the disk(s) to the Bioclinica Portland, Oregon, USA office per the instructions
provided in study-specific materials.

OR

Submit data through SMART Portal*

*For technical support, please contact our HelpDesk team.


Contact information is located on the study specific Quick Reference Guide.

Note: Contact your Bioclinica Study Team to acquire your instructions and online
password to utilize the web based submission. It is not necessary to send any hardcopy
materials to Bioclinica when submitting data online. Patient data should be uploaded
under the study code and site number, while IQC data should be uploaded under the
DXA IQC Submission or IQCS-003 study, and scanner ID (unless alternate study
specific procedures have been provided)
Please notify the IQC department with any questions or concerns with copying IQC data
at IQC@bioclinica.com

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4.2 GE Lunar—Windows version 15.10 and any future software versions that
generate the phantom database files using SQL (not as an .mdb file).
The Export Database option lets you export results for all exams in the IQC database to
tab-delimited text files, which can be imported into a spreadsheet program such as
Microsoft Excel.

Follow the large BLUE ARROWS, for step-by-step instructions

1. Select the database you want to export from the Database sidebar.
2. Select Directory menu > Database Utilities > Export.

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3. Follow the steps on screen to customize the output.

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10

11

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4. In the Text File field, enter a path and filename. The path is the drive on
your computer where you will save the file that contains your phantom
database.

Note: Use your Scanner Number, as printed on your DXA Service


Record Form, for the filename.

Note: Write this path and filename down on a piece of paper to use when
preparing to send to Bioclinica--make sure to copy the name exactly as it
appears:
Example: c:\12345.txt

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This filename will be used as a prefix for the output files to be generated.

5. Click Finish and exams in the database are exported to tab-delimited text
files, saved at the path you specified

Copy the Phantom Database


a. Insert the media into the drive.
b. From the Windows desktop, open “My Computer”.
c. Find and open the directory containing the phantom database (the
location you wrote down above).
d. To a disk:
i. Find and select the text file that you created (e.g. c:\12345.txt--
where “12345” = the scanner number of your machine, that you
entered when saving the file).
ii. Right click the text file and select the “Send To” cascading menu
from the drop down list.
iii. Select the disk drive for the electronic media the file will be copied
to.
e. To a CD:
i. Copy the text file to the computer desktop.

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ii. Use the CD writing software installed on the computer to write the
file to a CD.
iii. Be sure to let the CD writing software finish fully and eject the CD.
iv. To verify the file has been copied to the CD, put the CD back in
the drive, open the ‘View’ tab, select ‘Refresh’, the file should
appear in the window, do not open the file as this can corrupt
the data.
Verify that the disk(s) or CD contain the files:
f. Double-click the “My Computer” icon.
g. Double-click on the drive that contains the media on which the data is saved.
h. Check that the text files appear, indicating that the database copy routine was
successful.
Ensure that you remove the files from your desktop location when
complete, to avoid sending the same files in future submissions

Ship data to Bioclinica


6. Remove the electronic media and label it with the IQC electronic media
label including scanner ID number and complete the IQC Transmittal Form.
7. Send the disk(s) with the IQC Transmittal Form to the Bioclinica Portland,
Oregon, USA office per the instructions provided in study-specific materials.
OR

Submit data through SMART Portal*

*For technical support, please contact our HelpDesk team.


Contact information is located in the study specific Quick Reference Guide.

Note: Contact your Bioclinica Study Team to acquire your instructions and online
password to utilize the web based submission. It is not necessary to send any
hardcopy materials to Bioclinica when submitting data online. Patient data should be
uploaded under the study code and site number, while IQC data should be uploaded
under the DXA IQC Submission or IQCS-003 study, and scanner ID (unless alternate
study specific procedures have been provided)
Please notify the IQC department with any questions or concerns with copying IQC
data at IQC@bioclinica.com

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4.3 GE Lunar—Windows version 15.10 and any future software versions that
generate the phantom database files using SQL (not as an .mdb file) –
Alternate option if unable to export .txt file.
This option lets you copy results for all exams in the IQC database in .mdf format directly
onto a CD or desired location for courier or electronic submission.

1. Open the GE-Healthcare (Lunar) software and identify the Database


where the Phantoms are saved. Typically this is “(local)\Phantom
Database Name”. If it is not (local), please contact your IT department.

2. From the Windows desktop, open “Computer”


3. Browse to the local disk drive C: and search for the Phantom_XXXXX.mdf
file, where Phantom_XXXXX is the name of your phantom database.

4. Right-click on the .mdf file and click Send to. Select your CD drive.
5. Use the CD writing software installed on the computer to write the file to a
CD.

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6. Verify the contents on the CD by opening “Computer” and selecting your


CD drive.
7. Remove the media and label it with the IQC electronic media label
including scanner ID number and complete the IQC Transmittal Form.
8. Send the disk(s) with the IQC Transmittal Form to the Bioclinica Portland,
Oregon, USA office per the instructions provided in study-specific
materials.

OR

Submit data through SMART Portal*

*For technical support, please contact our HelpDesk team.


Contact information is located in the study specific Quick Reference Guide.

Note: Contact your Bioclinica Study Team to acquire your instructions and online
password to utilize the web based submission. It is not necessary to send any
hardcopy materials to Bioclinica when submitting data online. Patient data should be
uploaded under the study code and site number, while IQC data should be uploaded
under the DXA IQC Submission or IQCS-003 study, and scanner ID (unless alternate
study specific procedures have been provided)
Please notify the IQC department with any questions or concerns with copying IQC
data at IQC@bioclinica.com

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4.4 GE Lunar—Windows – (software versions 10.0 and above) Instructions for


copying QA block
Note: QA Block can only be used for baseline and ongoing QC processes if your
scanner is capable of QA Block Repeats (second passing activated).
Below are instructions on how to copy the QA.mdb file to a CD.

1. Exit the GE-Healthcare (Lunar) software by clicking File on the menu bar.
Then click Exit.

If a Compress Database window appears like the one below choose Yes
or No depending on what the GE-Healthcare (Lunar) Representative has
recommended.

2. The Close window will appear. Choose exit enCore.

3. Click OK.
4. Insert the CD into the CD Drive. Format the CD if prompted.

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5. Click Start located at the bottom left corner of the monitor.


6. Click My Computer.
7. The My Computer window will appear. Double-click to open the local disk
drive. The local disk drive may be D applications or E applications or local
disk (C:). Always try the applications drive first.

8. Double click on a folder named Program Files.

9. Double click on a folder named Lunar.

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10. Double click on a folder named Prodigy or Encore or iDXA. Folder name
will be dependent on software version being used.

11. Double click on a folder named Config or conFigme. Folder name will be
dependent on software version being used.

12. Double click on a folder named QC.

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13. Locate the QA.mdb file. The QA.mdb file will most likely be at the very
bottom.

Note: If you only see a QA.ldb file, go back to Step 1 and exit the GE-
Healthcare (Lunar) software.
14. Right click on the QA.mdb file to activate the shortcut menu.
15. Click Send To.

16. Click on the CD drive. The QA.mdb file will begin to copy to the disk. Use
the CD writing software installed on the computer to write the file to a CD.
17. Once the copying process is finished, check to make sure the QA.mdb file
is on the CD by clicking Start located at the bottom lower corner of the
monitor.
18. Click My Computer.
19. The My Computer window will appear. Double click on the CD drive. The
QA.mdb file should now appear in the My Computer window.
20. Once you have verified that the QA.mdb file is on the media, take the media
out of the drive.
21. Label the media with the pre-printed scanner labels provided and complete
the IQC Transmittal Form.
22. Send the disk(s) with a completed IQC Transmittal Form to the Bioclinica
Portland, Oregon, USA office per the instructions provided in study-specific
materials.
OR
Submit data through SMART Portal*

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*For technical support, please contact our HelpDesk team.


Contact information is located in the study specific Quick Reference Guide.

Note: Contact your Bioclinica Study Team to acquire your instructions and online
password to utilize the web based submission. It is not necessary to send any
hardcopy materials to Bioclinica when submitting data online. Patient data should be
uploaded under the study code and site number, while IQC data should be uploaded
under the DXA IQC Submission or IQCS-003 study, and scanner ID (unless alternate
study specific procedures have been provided)
Please notify the IQC department with any questions or concerns with copying IQC
data at IQC@bioclinica.com

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4.5 GE Lunar—Windows – (software versions 10.0 and above) Instructions for


copying QA block – Alternate option

1. Insert the CD into the CD Drive. Format the CD if prompted


2. From the main GE Healthcare (Lunar) screen, select Tools > Send Configuration

3. Select QA Database and Send to Disk

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4. Select your disk drive or desktop location if submitting through SMART Portal.
5. Click OK.
6. Click on the CD drive. The QA.mdb file will begin to copy to the disk. Use the CD
writing software installed on the computer to write the file to a CD.
7. Once the copying process is finished, check to make sure the QA.mdb file is on the CD
by clicking Start located at the bottom lower corner of the monitor.
8. Click My Computer.
9. The My Computer window will appear. Double click on the CD drive. The QA.mdb file
should now appear in the My Computer window.
10. Once you have verified that the QA.mdb file is on the media, take the media out of the
drive.
11. Label the media with the pre-printed scanner labels provided and complete the IQC
Transmittal Form.
12. Send the disk(s) with a completed IQC Transmittal Form to the Bioclinica Portland,
Oregon, USA office per the instructions provided in study-specific materials.
OR
Submit data through SMART Portal*

*For technical support, please contact our HelpDesk team.


Contact information is located in the study specific Quick Reference Guide.

Note: Contact your Bioclinica Study Team to acquire your instructions and online
password to utilize the web based submission. It is not necessary to send any
hardcopy materials to Bioclinica when submitting data online. Patient data should be
uploaded under the study code and site number, while IQC data should be uploaded
under the DXA IQC Submission or IQCS-003 study, and scanner ID (unless alternate
study specific procedures have been provided)
13. Please notify the IQC department with any questions or concerns with copying IQC data
at IQC@bioclinica.com

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5 APPENDIX E: DISABLING THE AUTO-ANALYSIS FEATURE—GE


LUNAR ENCORE

It is not possible to permanently disable the Auto-Analysis feature for all analyses in the GE
Lunar enCORE software platform. Analysis just after DXA examination acquisition can be
disabled as described below.

5.1 Avoiding Analysis after Acquisition of a New DXA Examination


It is not possible, in this software, to view a DXA scan image after acquisition in the
unanalyzed state.

To avoid analysis immediately after acquisition while in the New Measurement Window, be
sure the “Analyze When Done” box is unchecked. This feature will remain disabled as
long as the DXA technologist does not recheck the box for subsequent acquisitions.

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5.2 Verifying the Status of Analysis


The status of analysis can be verified by selecting a patient and then observing the lack or
presence of analysis dates for each scan for that patient in the lower screen.

The example below demonstrates that the Right Forearm DXA scan was analyzed on 28-
Sep-2010 and that the Total Body, Left Femur and AP Spine DXA scans have no analysis
date.

If the scan is inadvertently or intentionally opened the software will perform an Auto-
Analysis. This analysis may or may not be valid as further review by properly trained staff is
needed to ensure the accuracy of an Auto-Analysis.

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5.3 Unanalyzing the Analyzed DXA Scan

A DXA scan can be unanalyzed by choosing the “Unanalyze” option from the “Analyze”
menu.

After selecting the “Unanalyze” option from the drop down menu the “Unanalyze” window
appears. Select the scan(s) to be unanalyzed and then click on the “OK” button.

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