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DOC. ID: DXQC2022

REVISION: H
MANUFACTURING PROCEDURES
DATE: 5/10/04
GE Medical Systems WRITTEN BY: Vikram Ray
LUNAR APPROVED ON CO: L11026
TITLE: enCORE Aluminum Spine Phantom Scanning Procedure

PURPOSE
This procedure details the process for scanning aluminum spine phantoms on PRODIGY/
PRODIGY ADVANCE or DPX-NT / MD+, DPX Bravo/ DPX Duo scanners at the time of
system installation and or system service.

APPLICATION
This policy applies to all PRODIGY/ PRODIGY ADVANCE, DPX-NT / MD+, DPX Bravo/
DPX Duo scanners installed or repaired in the field.

SAFETY PRECAUTIONS
The x-ray generator produces a beam of ionizing radiation. The technician should take
precautions to avoid exposing any part of their body to the x-ray beam.
The patient localizer light is a laser diode. The technician should not look directly into
the laser.

ASSOCIATED MATERIALS
DXAP2000 PRODIGY/ PRODIGY ADVANCEInstallation Work Instructions
DXAP2003 PRODIGY/ PRODIGY ADVANCEInstallation Test Procedures
DXAP2004 PRODIGY/ PRODIGY ADVANCEInstallation Report Form
DXAP3000 DPX-NT / MD+ Installation Work Instructions
DXAP3002 DPX-NT / MD+ Installation Test Procedures
DXAP3004 DPX-NT / MD+ Installation Report Form
DXAP4000 DPX Bravo/ DPX Duo Installation Work Instructions
DXAP4002 DPX Bravo/ DPX Duo Installation Test Procedures
DXAP4003 DPX Bravo/ DPX Duo Installation Report Form

DEFINITIONS
None.

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GE Medical DOC ID: DXQC2022 REV: H DATE: 5/10/04 CO: L11026
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THEORY / OVERVIEW
As part of the installation / service quality assurance tests, scan the aluminum spine
phantom to monitor the accuracy and precision of the scanner before and after a repair or
installation is performed. The spine phantom is encased in a low attenuating material
(lucite) or is in a water bath. If the phantom is a water bath phantom, the container must be
filled with room temperature water, up to the water line mark on the bath.

The phantom represents the typical density range and size of a normal human spine.
The spine phantom (Figure 1) consists of vertebrae L1 through L4. Parts of vertebrae
T12 and L5 are landmarks used by the program during analysis.

Figure 1 Spine phantom

The phantom includes an ESTABLISHED BMD VALUE, encapsulated phantoms

have the value printed on them, water bath phantoms have an information sheet
shipped with them.

As part of the enCORE based system installation, the installer calculates an average
BMD value for the spine phantom. This calculated value is then used to compare to the
value measured on the system before it left the LUNAR factory. Complete the
procedure that follows to determine and record the values.

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It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use.
This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed,
used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.
GE Medical DOC ID: DXQC2022 REV: H DATE: 5/10/04 CO: L11026
Systems

PROCEDURE

I. Acquiring an Aluminum Spine Phantom Scan

A. Verify that three (3) calibrations have been run on the scanner. These shall
have been run within the previous week. If a calibration has not been run
within the last two days run a calibration. If all of the calibrations
are more than a week old, rerun all three.

B. Scanning the Spine Phantom

1. Enter patient information for Spine Phantom (if it has already been
entered, go to step E).

2. Enter the Directory by selecting the Directory F4 button from the

main screen. Open the New Patient dialog by clicking the New
button on the Directory toolbar.

System Number

Today’s date –
40 years

Figure 2: New Patient Dialogue Box with Spine Phantom Patient information
entered in the appropriate fields.

3. Enter the demographics in Figure 2 into the New Patient dialog, where
First name field can also contain the scanner number.

4. Select Secondary Information tab. Record the information that follows:

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This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed,
used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.
GE Medical DOC ID: DXQC2022 REV: H DATE: 5/10/04 CO: L11026
Systems

• Record the phantom serial number given on the L5 region of the

spine phantom.
• Record the expected value for the phantom.

5. Click OK to close the dialog box and save the new patient information.

6. Double-click the Phantom patient in the Patient List to enter the New
Measurement screen.

7. The New Scan Screen shows a skeletal image which gives the scan sites
available for measuring. Use the mouse to click on the image’s AP spine.

8. The site you selected (AP Spine) is highlighted in the Site(s) list. In
addition, the applicable scan mode for the site is highlighted in the
Mode(s) list.

9. If the software version permits (versions 3.50 and greater only – also
system must be in service mode) and you wish to acquire multiple scans
enter the number of scans in the scan count box. If you are using this
option, also check the Analyze when done box.

10. The following information should also appear:

• Length (cm): (dependant on height entered – will be correct if the

demographics were entered correctly)

• Width (cm): 18.0

• Voltage: 76.0 kv

Current: 3.00 mA (PRODIGY) 1.50 mA (DPX-NT) 0.750 mA

(MD+), 1.5 mA for DPX Bravo/ DPX Duo

11. Position the spine phantom (figure 3) in the center of the scan table pad
(➊) across from the center of the longitudinal axis (➋). Make sure the
straps on the spine phantom holder are not in the scan region
(encapsulated phantom only). If the phantom is a water bath phantom,
make sure that the cover is off of the water bath.

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This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed,
used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.
GE Medical DOC ID: DXQC2022 REV: H DATE: 5/10/04 CO: L11026
Systems

Figure 3: Spine Phantom position

12. Position the phantom so T12 is toward the head of the scan table (see
Figure 4).

FOOT HEAD

Figure 4. Spine phantom detail on the tabletop

13. Select Position from tool bar. A graphic is shown which illustrates correct
patient and laser position for the scan type.

14. The scan arm and detector also move to the approximate start position
and the program turns on the laser light.

15. Position the laser crosshair in the on the letter “R” in the word “LUNAR” on
the L5 vertebral body of the phantom.

16. Monitor the first few lines or sweeps to make sure the detector position is
correct. The scan starts in region L5 and moves across the phantom.
THE DETECTOR MUST NOT SCAN AIR DURING THE ACQUISITION.
Abort the measurement by clicking on the abort button on the tool bar
when ½ of T12 is visible on screen.

17. Follow the on screen prompts to save the scan – if you are acquiring
multiple scans with version 3.50 or greater and have entered a value
greater than 1 in the scan count box, allow the scanner to acquire all
scans. There is a 30 second delay between scans, scans will start
automatically and will end at the same point as the initial scan. When all
scans have been completed under this option, the scanner will move to
the analysis mode automatically.
QUALITY SYSTEM DOCUMENT Page 5 of 8
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This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed,
used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.
GE Medical DOC ID: DXQC2022 REV: H DATE: 5/10/04 CO: L11026
Systems

18. After the scan, remove the spine phantom from the scan table.

B. Analyze the Spine Phantom

NOTE: The procedure below assumes you are familiar with AP Spine
scan analysis. Refer to the enCORE Operator’s Manual for more
information.

1. Click on the Analyze button on the tool bar – highlight Phantom and then
select analyze (not necessary if the analyze when done box was
checked).

2. Spine phantom image appears on screen. Patient information is located

in the lower right corner for verification.

3. Select ROI’s from tool bar for analysis. Verify intervertebral (IV) markers
are between the vertebral bodies.

4. It is necessary with spine phantom analysis to verify and adjust

accordingly for the following vertebral heights:
L2: 3.00 cm +/- .04 cm
L3: 3.50 cm +/- .04 cm
L4: 4.00 cm +/- .04 cm
L2-L4 region height should be 10.5 cm.

5. Verify markers are correctly identified. Label ROI’s, from standard

analysis tool bar, if necessary.

6. If the scans were acquired with version 3.50 or greater, the scans may all be
analyzed together and statistics are calculated automatically.
a. Right click on the image and Select Copy
ROI Special from the popup menu.

b. A mini-Directory will appear. Select all the

images you wish to be included (including
the open file) and click OK.

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It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use.
This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed,
used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.
GE Medical DOC ID: DXQC2022 REV: H DATE: 5/10/04 CO: L11026
Systems

c. The program will analyze and save all the scans (copying the ROIs
from your open file), then display a statistics summary showing: Scan
Mode, region BMD, BMC, Area, %fat, and filenames, along with Mean,
SD and %CV statistics.

d. This summary can be printed or exported to a txt file.

7. Select Results once analysis is complete.

8. Select Save to save analyzed results – you will be prompted to save each
image acquired if multiple images were acquired under version 3.50.

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It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use.
This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed,
used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.
GE Medical DOC ID: DXQC2022 REV: H DATE: 5/10/04 CO: L11026
Systems

9. Select Report to designate output options in the report dialog box. Select OK
to when finished.

10. The L2-L4 value must be within 3% (encapsulated) 3% (water bath) of the
average BMD value. (Established BMD is located on the phantom for
encapsulated phantoms or on the paper work shipped with the phantom for
water bath based phantoms.) If the average BMD values repeatedly vary by
more than 3%, call the LUNAR Customer Support Department

11. For system installations or System moves, record the BMD value of region
L2-L4 on the PRODIGY/ PRODIGY ADVANCEInstallation Report Form
(DXAP2004) or the DPX-NT / MD+ Installation Report Form (DXAP3004),
calculate the average (mean) and % variance. Include the original copies of
the scans (3 required) with the Installation Report (sent back to LUNAR). For
service visits, enclose the original phantom scans with the Service Report
(sent back to LUNAR).

GENERATED RECORDS
None

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This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed,
used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.