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enCORE PDF
enCORE PDF
enCORE PDF
© 2017 GE Healthcare
1 Safety ............................................................................................................25
Precautions for Standard Operating Procedures........................................ 25
Operator Safety............................................................................................. 26
Personnel Monitors ..................................................................................... 26
X-Ray and Shutter Graphics ....................................................................... 27
X-Ray Shutter............................................................................................... 27
X-Ray Power Supply .................................................................................... 27
Patient Safety ................................................................................................ 27
Mechanical Safety......................................................................................... 29
Symbols ......................................................................................................... 29
Sample Labels ............................................................................................... 30
Failsafe Circuit ............................................................................................... 35
X-Ray Shielding Requirements ..................................................................... 35
Electrical Safety............................................................................................. 36
Peripheral Configurations ........................................................................... 36
Scatter Radiation .......................................................................................... 37
2 Product Information ....................................................................................39
Intended Use ................................................................................................. 39
Indications for Use ........................................................................................ 39
Cautions for DXA Determinations ................................................................ 41
Device Descriptions ...................................................................................... 42
Scanner Table Assembly............................................................................... 47
Training Information ..................................................................................... 50
Classifications................................................................................................ 50
Installation and Operation............................................................................ 50
Software Installation..................................................................................... 50
Features......................................................................................................... 51
Hardware Features ..................................................................................... 51
Software Features ....................................................................................... 51
Quality Assurance (QA) Features ................................................................ 52
User Information ......................................................................................... 52
Options......................................................................................................... 52
3 Daily Use .......................................................................................................55
Headquarters/Legal Germany
Manufacturer
Beethoven Str. 239
GE Medical Systems Ultrasound & GE Medical Systems SCS
Primary Care Diagnostics, LLC. D-42655 Solingen
283 rue de la Minière
Street address: Germany
78530 BUC, France
3030 Ohmeda Dr. Phone: +49–212–2802–0
USA
Mailing address:
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, a General Electric company, doing business as GE Healthcare/GE
Santé au Québec.
1. LICENSE.
This License allows You to:
(a) use the Software on a product in accordance with the accompanying documentation. To "use" the Software means that the Software
is either loaded in the temporary memory of a computer or installed on any permanent memory or media of a computer (e.g., hard
disk, CD-ROM, optical disk, zip disk, and the like);
(b) make one (1) copy, in machine-readable form, of the Software as provided to You solely for the purposes of backup; provided that such
copy includes the reproduction of any copyright notice or other proprietary notice appearing in or on such Software.
2. LICENSE RESTRICTIONS.
(a) YOU MAY NOT, EXCEPT AS EXPRESSLY PROVIDED FOR IN THIS LICENSE: (i) DECOMPILE, DISASSEMBLE, OR REVERSE ENGINEER THE
SOFTWARE (except to the extent applicable laws specifically prohibit such restriction); (ii) COPY, MODIFY, ADAPT, TRANSFER, TRANSLATE, RENT,
LEASE, GRANT A SECURITY INTEREST IN, OR LOAN THE SOFTWARE OR ANY PORTION THEREOF; (iii) CREATE DERIVATIVE WORKS BASED UPON
THE SOFTWARE OR ANY PORTION THEREOF; OR (iv) REMOVE ANY COPYRIGHT OR PROPRIETARY NOTICES OR LABELS IN OR ON THE SOFTWARE.
(b) You understand that GE Healthcare may update or revise the Software, and in so doing incur no obligation to furnish such updates to You
under this License. GE Healthcare has no obligation to improve, update or support the Software in the future.
(c) In the event the instrument or product designated for the Software is sold or otherwise transferred to a third party, that party is not
authorized to use the Software unless they first pay to GE Healthcare the applicable license fee and agree to the terms and conditions of a
Software License Agreement. Upon transfer of the Software or any copy thereof, the License granted hereunder shall terminate immediately.
4. EXPORT LAW.
You agree that neither the Software nor any direct product thereof is being or will be shipped, transferred or re-exported, directly or indirectly
into any country prohibited under United States law or regulations promulgated thereunder.
5. WARRANTY.
GE Healthcare warrants that, to the best of our knowledge, the software provided with this License will perform as described in the
product's operator's manual and the technical specification for this Software. This limited warranty is contingent upon proper use of the
Software and does not cover any Software which has been modified, subjected to malicious logic, unusual physical or electrical stress, or
used on computer equipment not specified by GE Healthcare.
GE Healthcare does not warrant that the functions contained in this Software will meet your requirements, or that the operation of the
Software will be uninterrupted or error- free. Statements made about this Software do not constitute warranties and shall not be relied upon
by You in deciding whether to purchase the GE Healthcare product or use the Software. IN NO EVENT SHALL GE Healthcare BE LIABLE TO
YOU FOR ANY DAMAGES ARISING OUT OF THE USE OR INABILITY TO USE SUCH SOFTWARE.
THE SOLE AND EXCLUSIVE REMEDY IN THE EVENT OF DEFECT IS EXPRESSLY LIMITED TO THE REPLACEMENT OF THE SOFTWARE PROVIDED. IF
FAILURE OF THE SOFTWARE HAS RESULTED FROM ACCIDENT OR ABUSE, GE HEALTHCARE SHALL HAVE NO RESPONSIBILITY TO REPLACE
THE SOFTWARE.
GE Healthcare will consider this warranty to be void if You fail to comply with the terms in the Software License Agreement.
7. MISCELLANEOUS.
This Agreement represents the complete agreement concerning this License and may be amended only by a writing executed by both
parties. The License is governed by the laws of the State of Wisconsin, U.S.A. without regard to its conflict of laws principles. If any provision
of this Agreement is held by a court of competent jurisdiction to be unenforceable, that provision shall be enforced to the maximum extent
permissible and/or reformed only to the extent necessary to make it enforceable, and the remaining provisions of this Agreement will not
be affected or impaired in any way. If any legal action or proceeding is brought for the enforcement of this Agreement, or because of
any alleged dispute, breach, default or misrepresentation in connection with any of the provisions of this Agreement, the successful or
prevailing party shall be entitled to recover reasonable attorneys' fees and other costs incurred in such action or proceeding, in addition to
any other relief to which such party may be entitled.
WEEE Label
This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be
collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of
your equipment.
If you contract with GE Healthcare for the disposal of your scanner, GE Healthcare will properly dispose of these materials. If you choose
to dispose of your scanner yourself, both substances must be disposed of in accordance with local regulations. Contact your local GE
representative for WEEE information.
Tube head assembly GE Medical Systems Ultrasound & Primary 8548 or 45649
Care Diagnostics, LLC X-Ray Tube Head
Assembly
1. Do not attempt to operate the x-ray bone densitometer without first reading
this manual.
2. Do not remove the assembly panels or attempt any repairs without prior
instructions from authorized personnel.
3. Perform the Quality Assurance procedure each morning. If any test fails, check
the position of the calibration block and rerun the QA procedure. If a test fails
again, contact GE Support. Also, call GE Support if more than two failures occur in
a one-week period. If the room temperature changes more than 5°C during the
day, perform another daily QA.
4. If the patient is or might be pregnant, always contact the patient's physician
before performing a scan.
5. Remain in visual contact with the patient while a scan is in progress. Ensure that
the patient does not move during the measurement. Minimize the amount of time
the patient lies flat on the scan table.
6. Restrict access to the room to authorized personnel.
7. Do not attempt to service any of the system's electrical components while the
x-ray bone densitometer is turned ON. High voltage is used to produce x-rays.
8. Radiation safety information is located within this manual you received with your
system. Review this information before operation.
9. To stop the x-ray bone densitometer in an emergency, press the emergency
stop button on the scan arm. DO NOT use the emergency stop button to routinely
abort a scan.
10. Immediately remove any fluids spilled on the pad or any surface of table.
11. All surfaces should be cleaned to meet site's guidelines for handling blood and
body fluids. Pad material may be damaged by certain chemicals. Use appropriate
hospital grade disinfectant (for example: Cidex®, HB Quat, Precise®, PDI) followed
by mild detergent.
12. Do not generate x-rays through the use of remote applications.
13. Protect the computer against malicious logic and unauthorized network
access. Only allow authorized user access. Prevent virus attacks by using
firewalls, anti-virus software and software patch updates. Contact your local GE
representative for more information.
14. DPX Duo: Extend the step the full distance to provide maximum surface area for
the patient to get on and off the table without risk of injury.
15. DPX Duo: Do not place an excessive load on foot rest stirrup (maximum load
is 60 pounds), drawers (maximum load is 100 pounds), or leg extension table
(maximum load is 300 pounds).
16. DPX Duo: Do not sit on leg extension table.
Operator Safety
Because the DXA has two control points (PC and front panel), the operator should
visually ensure that no person is near moving parts, pinch points, or the x-ray beam
before starting a scan. The operator must understand the use of the emergency stop
button on the front panel. See Emergency Stop Button (57).
DPX NT/MD, DPX Duo/Bravo, and Prodigy scanners: To avoid scatter radiation, the
operator should remain at least 3 feet (1 meter) away from the center of the scanner.
iDXA scanners: To avoid scatter radiation, the operator should remain at least 6 feet (2
meters) away from the center of the scanner.
Maximizing the distance from the patient will decrease the operator’s exposure
to scatter radiation; however, the operator should maintain visual or voice contact
with the patient at all times. Optional protective equipment will further reduce the
operator’s exposure to scatter radiation.
Personnel Monitors
Personnel monitors are not necessary to operate the scanner.
It is not likely that you can receive more than 25% of the maximum permissible x-ray
dose from the scanner. However, some facilities choose to use personnel monitors.
Refer to your city, county or state Health Department or Radiation Safety Officer
for your facility's policy.
Film badges and thermal luminescent dosimeter (TLD) badges are obtained from a
supplier accredited by the National Voluntary Laboratory Accreditation Program for
personnel dosimetry processing.
The following is a sample situation for a clinic measuring an AP spine and Dual Femur
on 5 subjects per day with an exposure rate of 0.18mR/hr at a distance of 2 meters
estimated from the iDXA isodose curves.
Sample Calculation for Estimated Exposure per Year from Scatter with iDXA
Densitometer
Scan Type Mode Average Scan Equivalent
Scans/Day Time/Day 2.5 mA Scan
(sec/day) Time/day
(sec/day)
AP Spine Standard 5 260 260
Dual Femur Standard 5 535 535
2.5 mA Scan Time per Day (sec) 795
2.5 mA Scan Time per Day (hours) 0.221
X-Ray Shutter
When power to the scanner is interrupted during a measurement or Quality Assurance
procedure, the shutter closes and the x-ray tube stops generating x-radiation.
Patient Safety
Pinch Points
This label identifies the location of possible pinch points.
When the scanner arm is in motion, make sure possible pinch point areas are clear at
all times. Patient limbs must remain inside the boundaries of the table top. A pinch
point is possible between the scanner arm and table.
Laser Safety
DO NOT STARE INTO THE LASER BEAM during patient positioning and Quality
Assurance procedures. This label is located under the scanner arm and shows the
location of the laser aperture:
The laser aperture is located on the underside of the scanner arm, facing the patient.
Keep the laser aperture away from the patient’s eyes during patient positioning.
Radiation Safety
X-ray exposure: The system makes radiation when electric voltage is supplied to, and
current flows through, the x-ray tube. During a measurement, the shutter opens to let
a beam of radiation pass through the scanner table and patient.
For iDXA systems, the nominal radiation field at the scanner table top is 18.4 mm x
3.3 mm.
For Prodigy systems, the nominal radiation field at the scanner table top is 19.5 mm x
3.4 mm.
For DPX systems, the nominal radiation field at the scanner table top is 2 mm.
Lead oxide shielding surrounds the x-ray tube insert inside the tube housing assembly
and reduces radiation levels around the scanner table.
Mechanical Safety
The scanner arm moves down the entire length of the scanner table. Make sure the
patient does not interfere with the movement of the scanner arm to prevent possible
injury. In addition, make sure that there are no objects behind the scanner table that
might obstruct movement of the scanner arm.
iDXA scanners: Weight applied to the scan table bed must not exceed 204 kg (450 lb).
DPX NT/MD+ scanners: Weight applied to the scan table bed must not exceed 136
kg (300 lb).
DPX Duo/Bravo and Prodigy scanners: Weight applied to the scan table bed or
footstep (DPX Duo only) must not exceed 159 kg (350 lb).
Symbols
Symbol Name Description
Electronic Instructions Symbol indicating that the Instructions for Use
for Use are supplied in electronic form
or
Refer to Instruction Alerts the user that the User Manual contains
Manual important safety information
Sample Labels
Actual label appearance may vary from the samples displayed
in this section.
February August
April October
May November
June December
This label shows that the scanner uses a Class II laser and produces ionizing radiation
(x-rays).
Laser Radiation. Do not stare into beam. Class 2 Laser Product. Laser wavelength is
655 nm.
This label gives tube assembly and x-ray source characteristics information. It is
located on the tube head assembly (inside the scanner) and on the foot panel of the
scanner.
System Label
This label gives system input power requirements and compliance information. It is
located on the foot panel of scanners.
This label gives high voltage power supply (x-ray generator) information. It is located
on the high voltage power supply (inside the scanner) and on the foot panel of the
scanner.
This label shows x-ray controller compliance. It is located near the x-ray controller
(inside the scanner) and on the foot panel of the scanner.
Collimator Assembly
This label gives collimator assembly information. It is located on the collimator (inside
the scanner) and on the foot panel of the scanner.
Warning and Radiation Symbol Label
This label shows that the system uses ionizing radiation. It is found only on systems
delivered in the United States. Always obey instructions for safe operation.
This label states that grounding reliability can be maintained only when using a
"Hospital Grade" or "Hospital Only" receptacle. It is found on all power cords of
systems delivered in the United States.
Unique Device Identification Label
Every medical device has a unique marking for identification. The UDI marking
appears on the device labeling.
This is only an example of a UDI marking.
Failsafe Circuit
During operation, the scanner is constantly monitored for diagnostic failures. If a
diagnostic failure occurs, the failsafe circuit stops power to the scanner motors and
disables the x-ray system. A message is shown on the computer that describes the
failure. Call GE Support or your GE distributor and provide the failure description.
Electrical Safety
Insulate patient from any metal associated with the DPX Duo by using a
non-conductive material during cauterization or similar treatments to avoid
shock or burns.
Do not plug additional outlet strips or extension cords into power source
connected to scanner.
Peripheral Configurations
The correct connection of the computer and all peripherals is necessary to
maintain electrical safety. The signal cable of the scanner is intended only for
connection to an approved computer. Call GE Support or your GE distributor
before adding peripherals.
Failure to use outlet strips properly can cause medical electrical system
leakage currents in excess of 100 microamperes. For more information on
medical electrical systems, refer to IEC 60601-1.
Scatter Radiation
Refer to Scatter Radiation Diagrams (298) to see isodose diagrams of scanner scatter
radiation.
Provides a standardized bone density report using data from the densitometer and
physician-generated assessments based on the patient's demographics, which can
assist the physician in communicating scan results to the patient and the patient's
referring physician.
Optional Hand BMD software estimates the BMD at the hand.
Optional Dual-Energy Vertebral Assessment software provides an x-ray image of the
spine for qualitative visual assessment in order to identify vertebral deformations and
estimate vertebral heights (morphometry).
Optional Orthopedic software estimates periprosthetic BMD of an orthopedic hip
or knee implant (pre- and post-surgery).
DPX only: Optional Pediatric software option expands the range of bone densitometry
reference data to include ages 5 through 19 years. The software provides a
comparison of measure variables obtained by dual energy x-ray absorptiometry to
a database of reference values. These data can be used for comparative purposes
at the sole discretion of the physician.
Optional Complete Pediatric software option measures bone mineral content (BMC),
bone mineral density (BMD) and body composition (lean body mass and fat mass)
in patients from birth to 20 years of age. The software provides a comparison of
measured variables obtained by dual energy x-ray absorptiometry to a database
of reference values for patients 5-19 years of age. These data can be used for
comparative purposes at the sole discretion of the physician. The software does
not provide a reference population for comparative purposes for patients younger
than 5 years of age.
Optional Body Composition software measures the regional and whole body bone
mineral density (BMD), lean and fat tissue mass, and calculates other derivative values
which can be displayed in user-defined statistical formats and trends, and compared
to reference populations at the sole discretion of the healthcare professional. Some of
the diseases/conditions for which body composition values are useful include chronic
renal failure, anorexia nervosa, obesity, AIDS/HIV, and cystic fibrosis.
The MirrorImage function used on the GE Lunar DXA bone densitometers can be
used to estimate the total body composition and bone mineral density (BMD) when
regions of the body are outside of the scan window by using scanned data from the
corresponding region(s) on the opposite half of the body.
Optional CoreScan* software estimates the Visceral Adipose Tissue (VAT) content
within the android region in a male or female population between the ages of 18
and 90 with a BMI between 18.5 and 40, excluding pregnant women. The content
that is estimated is the VAT Mass and VAT Volume. The values can be displayed in
user-defined statistical formats and trends. Some of the diseases/conditions for which
VAT estimation can be useful include hypertension, impaired fasting glucose, impaired
glucose tolerance, diabetes mellitus, dyslipidemia and metabolic syndrome.
Optional total body composition software estimates the Resting Metabolic Rate (RMR)
in the male or female population age 18 and older. The data can be displayed in
user-defined statistical formats and trends.
Optional total body composition software estimates the Relative Skeletal Muscle Index
(RSMI) in the male or female population age 18 and older. The data can be displayed in
user-defined statistical formats and trends.
Optional Advanced Hip Assessment (AHA) software provides a measurement of hip
axis length (HAL) and a mean value of HAL for Caucasian and Asian females on
femur images. It also calculates hip geometry values used to evaluate the structural
properties of the hip.
The DPX-Duo has special mechanical features including stirrups, storage drawers, and
patient step to allow use as an exam table when bone densitometry is disabled and
the scan arm is rotated and locked parallel to the table.
Optional Atypical Femur Fracture (AFF) software uses femur images to visualize focal
reaction or thickening along the lateral cortex of the femoral shaft which may be
accompanied by a transverse radiolucent line. This software provides measurements
of the lateral and medial cortex width and quantifies focal thickening of the lateral
cortex along the femoral shaft. The beaking index can be displayed and trended
across serial scans.
Optional sarcopenia software calculates values based on published definitions and
thresholds using measured appendicular lean mass in combination with patient
demographics and entered values of muscle strength and physical performance.
These values may be useful to health care professionals in their management of
sarcopenia.
Device Descriptions
Structure
The device includes the following basic components:
1. An x-ray source with appropriate filtration to form a well-defined dual-energy
beam,
2. An x-ray detector capable of measuring the attenuated beam at two energy levels,
3. A support for holding the subject between the source and detector,
4. A mechanical means to move the source and detector in a rectilinear scan of a
selected area of the subject’s body, and
5. Software and electronic controls for the previously mentioned components.
6. Where applicable, phantoms and positioning blocks are used with the system.
Depending upon the enabled features, these components may vary or may not
be required.
7. Optional system components include the small room kit, which is used when
the PC is close to the table; encapsulated phantom, which is an encapsulated
aluminum spine in an acrylic block; and an uninterruptible power source (UPS).
The bone densitometer is divided into a scanner and a computer. The scanner
comprises the x-ray source and detector, the patient table, the mechanical drive
system, and the lowest level portions of the control system. The scanner is in
communication with the computer, which is a standard PC. The computer runs the
enCORE software, and thus controls the scanner, acquires scan data from the scanner,
stores and analyzes the data, and interacts with the human operator.
Error Description:
Swing arm not locked in scanning position. Please lock before continuing.
Corrective Action:
Please try again. If the problem persists, contact GE Lunar Support for assistance.
To retract the scan arm once the scan is completed, home the scan arm.
Pull the lever on the front of the scan arm towards you and push the scan arm to the
left until it rests along the back of the scanning table. The patient can then sit up and
the table is free of obstruction.
The power switch is located at the head of the table. There is also a roll at the head of
the table to store up to 21” x 3” (53.34 cm x 7.62 cm) exam paper. The table weight
limit is 159 kg (350 pounds).
DPX-Bravo
Item Description
1 Table pad
2 Swing scan arm
3 Scan arm control panel
4 Exam paper roll and power switch (head of scanner–not shown)
The DPX-Duo model also has mechanical features including stirrups, procedure
drawer, storage drawers, and patient step to allow use as an exam table when bone
densitometry is disabled and the scan arm is rotated and locked parallel to the table.
DPX-Duo
Item Description
1 Patient step
2 Storage drawers
3 Stirrups
4 Table pad
5 Swing scan arm (in scanning position)
6 Scan arm control panel
7 Exam paper roll and power switch (head of table–not shown)
8 Procedure drawer
DPX-NT/Pro/MD+
The DPX-NT, DPX-Pro, and DPX-MD+ models come in full and compact sizes and use
pencil beam technology with a single-crystal channel NaI detector. The power switch
is located on the lower front panel. The table weight limit is 136 kg (300 lbs).
DPX-NT
Item Description
1 Power switch
2 Table pad
3 Scan arm
4 Scan arm control panel
Item Description
1 Power switch
2 Table pad
Item Description
3 Scan arm
4 Scan arm control panel
iDXA/iDXA Forma
The Lunar iDXA uses fan beam technology with a 64-channel detector, is a scanner
designed for optimal image quality, and supports patient's weights to 204 kg (450 lbs).
The power switch and exam paper roll is located at the head of the scanner.
Lunar iDXA Series
Item Description
1 Exam paper roll
2 Table pad
3 Scan arm
4 Scan arm control panel
5 Power switch (head of scanner–not shown)
The Warning label identifies the location of possible pinch points. When the scanner
arm is in motion, make sure possible pinch point areas are clear at all times. The
technologist must keep both feet away from the moving carriage. Patient limbs must
remain inside the boundaries of the table top to avoid a pinch between the scanner
arm and table.
Scanner Table
No modification of the Scanner Table assembly is allowed. For service, please
call GE Support or your GE distributor.
The scanner table is used to support the patient during a measurement or general
examination (DPX Duo only). In addition, the x-ray source assembly and other
electronics are contained inside the scanner table.
Scanner Arm
The laser light, emitted from an aperture on the scanner arm, helps you locate the
measurement start position. Positioning switches let you move the scanner arm until
the laser light is located at the correct start position. The start position is different for
each measurement type.
On DPX Duo/Bravo scanners, the scan arm has a release and locking mechanism
allowing the upper arm to swivel when the scanner is idle. The scan arm must be in
the locked position over the scanner table to perform a measurement.
3 Positioning switches
3 Positioning switches
4 Start scan button
The following table describes the indicators located on the scan arm control panel.
The x-ray, shutter, and laser indicators are considered low priority alarm conditions as
defined in IEC 60601-1-8. The power indicator is not considered an alarm condition.
Symbol Indicator Status (on)
Green (power) Power is supplied to the scanner table
Positioning Switches
The positioning switches move the scanner arm and detector to the measurement
start position (the laser light indicates the position of the detector). The Back/Front
switch moves the detector across the width of the scanner table. The Left/Right switch
moves the scanner arm down the length of the scanner table.
Training Information
GE Healthcare or its authorized distributors provide individual, hands-on training as
part of the installation procedure for your system. (GE distributors provide training
for systems installed outside the United States.) An Applications Specialist provides
information on software and hardware operations, and reviews the warnings and
cautions in the manuals.
Classifications
Protection against electric shock: Class I, Type B
Protection against water: IPX0
Operation mode: Continuous operation
The device can neither be used in flammable anesthetic mixture with air nor
non-flammable anesthetic mixture with oxygen or nitrous oxide.
Software Installation
If loading software, you will be asked for your system number and feature code during
the installation procedure. These numbers are printed on a sheet included with the
software.
1. Put the DVD in the DVD drive.
2. When the Installation window appears, select the product software option.
If the installation does not automatically start, select
My Computer, select the DVD drive, and double-click the
software installation icon.
Features
Depending on the country, scanner model, and number of options you purchased, not
all of the features listed below may be included with your scanner:
Hardware Features
● DPX systems: Pencil beam technology.
● Prodigy and iDXA systems: Narrow-angle fan beam technology with Multi-View
image reconstruction.
● DPX systems: Single-element NaI detector.
● Prodigy and iDXA systems: Multi-element detector. Imaging performance meets or
exceeds 1.5 mm hole pairs and is limited by the Prodigy detector pitch of 3.2 mm.
● iDXA and DPX-Duo/Bravo systems: Paper roll dispenser.
● DPX-Duo/Bravo systems: Swing arm.
● DPX-Duo systems: Foot rests, patient step, two storage drawers, procedure tray.
Software Features
Not all features are available on all models.
● QuickView measurement application
● Total body measurement and analysis
● Pediatric spine measurement and analysis
● Pediatric total body measurement and analysis
● Pediatric femur measurement and analysis
● Pediatric assessments of growth and development including height for age, BMC
for bone area, bone area for height, lean body mass for height, and BMC for lean
body mass
● Lateral spine measurement and analysis
● Dual-energy vertebral assessment (lateral and AP)
● Spine geometry
● Hand measurement and analysis
● Small animal total body measurement and analysis
● ClearView filter for enhancing images by reducing soft tissue noise and improving
bone edges (user adjustable)
● Total body %fat and android/gynoid %fat estimation
● Resting Metabolic Rate (RMR) estimation
● Relative Skeletal Muscle Index (RSMI) estimation
● Sarcopenia calculator
● CoreScan – Visceral Adipose Tissue (VAT) estimation
● Body composition color coding and mapping
● AP spine measurement and analysis
● OneScan measurement application
● Femur measurement and analysis
● Atypical femur fracture measurement and analysis
User Information
● User Manual
Options
● Uninterruptible power supply (UPS)
3. Select OK.
The program archives the exam files from the computer hard drive to the archive
disk or external hard drive. The archive number for the file is shown in the Label
column of the Image list.
4. If an archive storage source needs to be initiated, the program prompts you to
insert a labeled archive disk in the appropriate disk drive. Insert a disk as directed.
The emergency stop button is the round, red button located on the scanner control
panel.
Do not use the emergency stop button to routinely stop the scanner during normal
operation.
1. Push the Emergency Stop button to stop a measurement in an emergency.
Power to the scanner table motors, x-ray tube head, shutter, and laser is turned off.
2. Select OK in the message window on the computer screen.
If there is a hardware problem, DO NOT try to measure a
patient. Call GE Support or your GE distributor.
Annual Maintenance
GE Healthcare recommends that you schedule annual preventive maintenance by
a GE-authorized service engineer after your warranty period expires. Contact GE
Support or your GE distributor.
1 Laser
2 Brass on bottom
4. Select OK, and follow the screen prompts to complete the QA procedure.
If the QA test did not pass, reposition the calibration block and repeat the
procedure.
If the procedure fails a second time, call GE Support for assistance.
5. To print the QA results (if the auto print option is not set) select Report. Keep
the QA printout for one year.
6. To trend the QA results, select Settings, choose Table or Graph, and select the
result that you would like to trend. Select OK.
Failures are represented by red dots on the graph.
Precision for other sites will range 1-3%. Precision may be affected by operator
technique and other variables associated with patient anatomy. See Cautions for DXA
Determinations (41) and Precision Calculator (181) for additional details.
AP Spine Thickness Dependence
The precision of BMD measurements over a soft tissue thickness range from 15 cm to
25 cm is less than or equal to 2% (%CV).
AP Spine Dependence on Height above Tabletop
The precision of BMD measurements over a 5 cm change in object plane is less than
or equal to 2% (%CV).
The printed DXA reports display a footnote indicating the precision error associated
with a measurement:
1 – Statistically 68% of repeat scans fall within 1SD (±0.010 g/cm2 for AP Spine L1-L4)
Accuracy
Accuracy indicates how close a measured value is to the actual value.
The Daily QA feature measures a standard black block which is supplied with
each scanner. The block consists of three chambers simulating BMD values of
approximately 0.500 g/cm2, 1.000 g/cm2, and 1.500 g/cm2. During Daily QA, the
BMD for each chamber is measured and checked that it is within 0.030 g/cm2 of
its expected value which ensures the linear correlation for BMD (R ≥ 0.99). At the
end of QA, the entire block is scanned to simulate an AP spine measurement and
the accuracy is checked again.
Navigate to QA > QA Trend Graphs to monitor QA trends for key values.
QA Controls
For more information about the QA GUI, refer to Quality Assurance Screen (235) and
Quality Assurance Toolbar (236).
For information about customizing the QA options, refer to QA Tab (249) in the Options
section.
Icon Item Description
Startup Test ● Database Validation
● Scanner Self-test
● QA Block Search
● Peaking
Mechanical Test ● Beam Stop
● Transverse Distance
● Longitudinal Distance
● Legacy QA Report
QA Phantom Report
QA Ancillary page
Legacy QA Report
A spine phantom baseline was performed with the installation of your scanner. This is
found in the patient database. For general use, use the same patient information that
was established with the spine phantom baseline scan.
For details on performing the scan, refer to AP Spine Measurement and Analysis (86).
1. Put 15 cm of water in the plastic container and position the aluminum phantom
in the middle of the plastic container.
2. Position the phantom so that L5 is toward the foot of the scanner.
3. From the Main screen, select Measure (F2).
4. Have you measured the phantom before?
a. If yes, select the phantom from the patient list and continue to step 7.
b. If no, continue to step 5 and 6 to record the information for the spine phantom.
5. Record the primary information in the dialog box:
Field Entry
First name Spine
Middle initial None
Last Name Phantom
Birth Date Record the current date minus 40 years.
For example, if today's date is September
28, 2011, type 09/28/1971. Do not
change this date for future spine phantom
measurements.
Height 67 inches or 170 centimeters
Weight 154 pounds or 70 kilograms
Sex Male
Ethnic Group White
Field Entry
Comments Record the phantom number given on
the L5 region of the spine phantom. Also
record your System ID number. This
number is located in Tools > User Options
> System tab.
10. When approximately half of T12 is imaged, select Abort from the toolbar.
11. Choose Save measurement from the Save dialog box and select OK if the
measurement was performed correctly.
12. For spine phantom analysis, it is necessary to verify and adjust accordingly for
the following vertebral heights:
L2: 3.00 cm +/- .02 cm
L3: 3.50 cm +/- .02 cm
L4: 4.00 cm +/- .02 cm
L2-L4 region height should be 10.5 cm
13. On the Analysis screen, select the ROI tool to view this information.
Measurement Warnings
Each scanner is equipped with a Class II Laser that is less than 1 milliwatt in
strength. DO NOT STARE INTO THE BEAM.
Remove foam leg block prior to positioning scan arm over the patient and
immediately after completing an AP Spine scan.
Verify that the patient's head, arms, knees, and any other body parts are not
in direct path of a moving scan arm.
Measurement Modes
Patient thickness determines the appropriate measurement mode. The program
defaults to the appropriate mode based on the patient's height and weight. Default
scan parameters are recommendations to be applied directly to allow optimized
operation. The operator makes the final decision based on patient thickness before
starting the exam. The selection of measurement modes influences the patient
radiation exposure. For more information about radiation exposure and measurement
modes, refer to the section Current and Typical Dose Tables (307).
iDXA: Patient Thickness Limits for enCORE Measurement Modes
iDXA iDXA Forma
Site Mode Patient Patient thickness
thickness or or weight
weight
Standard 15-25 cm
Thin <15 cm
Detail >15 cm
Standard 15-25 cm
Thin <15 cm
Standard 15-25 cm
Thin <15 cm
Lateral Standard NA
1. In the Patient list, highlight the patient and select Measure from the Common
toolbar.
The New Measurement screen is shown.
From the Main screen
1. Select Measure.
2. In the Patient Information dialog box, select Find.
3. Double-click the patient in the Patient list.
4. In the Patient Information dialog box, verify that the patient information is correct,
and then select OK.
The New Measurement screen is shown.
2. Record the necessary information in the three tabs in the Patient Information
dialog box.
Patient Information dialog box
● Primary tab: You must record the patient’s name, birth date, height, and
weight to complete a patient measurement. Change the default gender or
ethnicity in the Tools > User Options > Directory tab > Directory Rules and
Defaults button.
● Secondary tab: The Secondary tab lets you record comments and
administrative information that is not required to complete a patient
measurement. If the ISCD guidelines are turned on under Tools > User Options
> Systems, it is important to enter a menopause age for postmenopausal
women because the WHO criteria are only applied to postmenopausal women
and men age 50 and older.
● Additional tab: The Additional tab lets you record fracture, indication, and
treatment information for the patient. The tab also allows you to assign ICD-9
or ICD-10 codes to each fracture, indication, and treatment applied to all
patients. In addition, you can enter the patient’s insurance information. This
information is not required to complete a measurement.
1. On the New Measurement screen, click the site you want to measure.
The site you select is highlighted in the Exam list.
2. Follow the measurement procedure for the site you selected.
Refer to Measurement Modes (68) for more information.
Abort Measurement
If the image is not correct, or if you determine that a sufficient area of the
measurement has been obtained, select Abort (F5) from the New Measurement
toolbar.
When you select Abort, the measurement stops automatically when the detector
reaches the edge of the scan window. A message shows these options:
● Resume Measurement Select this option to continue the measurement.
● Save Measurement Select this option to save the current measurement.
● Reposition this measurement and do not save the aborted measurement Select
this option to start the measurement again using the same settings. The box that
is shown around the image shows the measurement area. Use the arrow keys
to move the box and reposition the measurement. Select Start from the New
Measurement toolbar to restart the measurement.
● "Set up a new measurement and do not save the aborted measurement Select
this option to change the settings for the measurement.
OneVision
The OneVision feature allows you to set up multiple measurements in one exam. This
eliminates keystrokes and improves throughput for customers that routinely perform
multiple measurements on each patient. OneVision is required for DICOM or HL7
reporting interfaces. By default, the enCORE software includes the exam combinations
of AP Spine + DualFemur, AP Spine + DualFemur + LVA, and Dual VA (LVA + APVA). Exam
combinations are found at the top of the Exam list on the New Measurement screen.
The images included in the exam are displayed in a tab view.
When scanning with a series of OneVision scan types, select Next to proceed to the
next image site in the exam, or Repeat the current measurement. Refer to Basic
Measurement Procedures (72) for information about obtaining appropriate image
measurements.
Create Exam Protocols
You can create your own exam protocols with the OneVision feature.
1. Select Measure > Create Exams.
QuickView
QuickView offers a fast, 10 second spine or femur scan. Measurement and analysis
procedures are the same as other scan modes.
The larger pixel width of QuickView results in reduced image resolution.
Standard scan modes provide optimal precision and are recommended for follow-up
scans to monitor changes in BMD.
For more details on the scan mode specifications, refer to Measurement Modes (68).
Select Image
These basic steps apply to all images. For specific instructions about site analysis,
refer to the topic for the specific site (for example, AP Spine Analysis (89) or Femur/Dual
Femur Analysis (96)).
1. From the Main screen, click Analyze, select the image to analyze, and click OK.
Or, from the Directory screen, select the patient from the Patient list, select the
image to analyze, and click Analyze.
You can use the Search option to locate a patient in a large database.
Adjust Image
After selecting an image (77), you can adjust it as needed.
1. Select Imaging from the Analyze toolbar to adjust the image:
The Image Tools window is shown.
2. Use this window to change the gray levels of the image and zoom the image.
The Image Tools window shows a bone profile and gives these options:
● Brightness: To adjust the brightness for the image, click and drag the
brightness scroll bar right or left.
● Contrast: To adjust the contrast for the image, click and drag the contrast
scroll bar right or left.
● ClearView: For LVA and iDXA AP Spine, Femur, and Forearm images, you can
adjust the sharpness. To increase or decrease the sharpness of the image,
move the arrow up or down the ClearView scale.
● Zoom: To zoom the image, use the bar to scroll through the percentage values.
Use the Pan tool if the image is larger than the window area on the Analyze
screen.
3. Click the Dialog Size icon in the lower left and select Advanced to adjust
Threshold, Range, Low/High Controls, or Image Type and to reset contrast.
4. Use these tools (shown on the Analyze screen (231)) to magnify an image during
analysis:
Icon Tool Description
Forearm correct bone point typing Lateral spine correct bone point typing
Examine Results
The Results tabs on the Analyze screen let you review BMD, reference, trend, and
composition results.
To change default settings for graphs, reference data, and results tables, refer to
Options (243).
Reference Graph
The reference graph provides a visual representation of the exam results compared
to a reference population. A patient's BMD, expressed in grams per centimeter
squared, is plotted against his or her age. The square with a black dot represents the
patient. Each colored bar below the dark green section represents one standard
deviation below the Young Adult value. The thin line separating the dark green from
the light green indicates a T-Score of –1. Following across, the patient’s T-Score can
be determined.
The T-Score indicates how many standard deviations a patient's BMD is from the
mean BMD value of the healthy Young Adult reference population. A negative T-Score
indicates the patient's BMD is below the Young Adult value. A positive T-Score
indicates the patient's BMD is above the Young Adult value.
T-Score
The blue bar displays the Age Matched Reference and demonstrates the change
in bone density associated with aging. The centerline of the blue bar is called a
regression line. The regression line shows the expected BMD at different ages for a
particular measurement site. The blue bar represents the expected Age-Matched BMD
± 1 standard deviation for a given patient.
Age-Matched Reference
● Reference results table: The results table shown below the Reference graph
gives the results for each region analyzed. To view the results for a region on the
Reference graph, highlight the region.
BMD values should be considered together with other risk factors (low body
weight, fracture history, corticosteroid use, use of long-acting tranquilizers, history
of falling) in the patient evaluation. In particular, patients with a prior history of
osteoporotic fracture should be considered to have double the risk of future
fracture at any density level.
Patient Trending
enCORE provides a monitoring tool to view changes in a patient's BMD over time. To
view trending results, 1) all of the trended measurements must be from the same site,
and 2) each trended measurement must be analyzed.
Scans with mixed positioning and/or analysis may not be trended together on all
graphs.
Trending Graphs
Select the Trend Results tab to view patient trending information.
Each measurement is shown as a separate square on the graph. A dot is shown
in the square that represents the current image. Trend graphs can be configured
as percent change or reference.
To change the graph display, go to Tools > User Options > Trending tab. Refer to
Options (236) for information about configuring User Options.
Scans with mixed positioning and/or analysis may not be trended together on all
graphs. Reference Only Trend Graphs (enabled in Tools > User Options > Results
Display tab > Reference Graph Options button > Graph section) allow mixed analysis
or positioner exams on the same trend graph (no BMD dependency).
Percent Change Trend Graph
OneScan
OneScan performs an AP Spine and DualFemur exam without repositioning between
scans. OneScan does not use the foam leg block positioner for spine positioning.
OneScan Measurement
The positioning graphics are tied directly to the configuration of the OneScan check
box.
OneScan is intended to be used without the leg block.
The screen changes slightly, depending upon whether the OneScan box is checked.
OneScan on OneScan off
4. Internally rotate the patient's legs, and secure the patient's feet to the foot brace.
It is suggested that you do not remove the patient’s shoes.
During a combined AP Spine and DualFemur (or single femur) measurement, the
software immediately proceeds to the femur setup. With the OneScan feature
enabled, the software proceeds directly to the positioning screen for adjustment
of the laser light position. The OneScan feature eliminates this pause, as the
patient is already positioned with their feet in the DualFemur brace for femur
measurements.
A pause may be enabled between scans. This option is found in Tools > User
Options > Measure tab. Check the desired options.
AP Spine Measurement
The positioning requirements for an AP Spine measurement depend on whether you
have chosen OneScan in Tools > User Options > Measure tab.
● If OneScan is checked for a specific measurement, do not use the foam block
positioner.
● If OneScan is not checked for a specific measurement, be sure to use the foam
block positioner.
For OneScan measurements, the T-Score calculation assumes the foam block is not
used.
1. Position the patient.
If you are using the foam leg block positioner:
a. Help the patient onto the scanner table and position the patient in the center
of the scan table.
b. Use the centerline on the table as a reference to align the patient.
The patient's arms should be on the scanner table, alongside the patient's
body.
Remove the foam leg block prior to positioning the scan arm and
immediately after the AP Spine scan.
2. Select the appropriate scan mode based on the thickness of the AP Spine area.
The scan mode for the AP Spine may be different than the scan mode used for
the femur, based on the patient's weight distribution.
3. Adjust the position of the laser light. Position the laser light approximately 5 cm
below the patient's navel and in the same longitudinal plane as the patient's
midline.
4. To start the measurement, select Start from the New Measurement toolbar
5. Monitor the image to make sure it is correct. Make sure that:
● The spine is in the center of the image
● (1) All of L4 (1) is shown
● (2) The top of L5 (2) is shown in the first 1-2 sweeps for iDXA and Prodigy
scanners
● (2) The top of L5 (2) is shown in the first 5-15 scan lines for DPX scanners
● (3) Approximately 1/2 of T12 is shown
6. If the image is not correct, select Abort, reposition the laser light, and restart
the measurement.
7. To complete another measurement for the patient, select Set Up from the New
Measurement toolbar.
8. If you have completed measurements for the patient, select Home to move the
scanner arm to the Home position
9. Select Analyze to proceed to Analysis, or Close to exit the Measurement screen.
AP Spine Analysis
1. If an image is not already open, select an image file for analysis.
The results may include a ScanCheck tab. Use ScanCheck
(183) to assist in the analysis of the image and to help you
make corrections where necessary.
2. If necessary, select Imaging from the Analysis tool bar to adjust the image.
3. If necessary, select ROIs from the Analyze toolbar to adjust the ROIs.
enCORE software will place the ROIs correctly most of the time. Do not make
adjustments to the analysis unless there is an obvious adjustment needed.
Make sure vertebrae are correctly identified and intervertebral (IV) markers are
between the vertebral bodies (1) and located at the lowest point of bone density
as indicated on the bone profile (2).
Analysis results
4. If you need to adjust ROIs for an AP Spine image, use these tools:
Icon Tool Description
Add ROI Select Add ROI to add an ROI during AP Spine
analysis. When you add a new ROI, it is inserted
below the ROI that is selected on the image.
Select Label ROI to label the ROIs accordingly.
Delete ROI Select Delete ROI to remove an ROI during
AP Spine analysis. Click the ROI, then select
Delete ROI. Select Label ROI to label the ROIs if
necessary.
Label ROIs Select Label ROIs to relabel ROIs after you have
added or deleted an ROI from an image.
Exclude ROIs This tool lets you remove ROIs from AP spine
results.
Select Exclude ROI, and then select the ROIs
you want to exclude from analysis. Parentheses
appear around the ROI labels of excluded ROIs.
Results for individual ROIs are shown even if the
ROIs are excluded from analysis. Excluded ROIs
are not included in the results for combinations
of vertebrae.
Show/Hide ScanCheck This tool lets you show/hide ScanCheck markers
Markers that indicate a possible high density area, such
as an artifact or osteophyte.
ScanCheck Markers is available only if ScanCheck
is enabled.
8. Select Save to save your changes, or select Close then No if you do not want
to save your changes.
Refer to Custom Analysis Procedures (180) and Estimated Total Body Fat and
Android/Gynoid Fat (129) for additional analysis information.
Femur/DualFemur Measurement
1. Help the patient onto the scanner table and position the patient in the center of
the scan table. Use the centerline on the table as a reference.
The patient's arms should be crossed over the chest, away from the side of
each hip.
4. Select the appropriate scan mode based on the thickness of the femur area.
The scan mode for the femur may be different than the scan mode used for the
AP Spine, based on the patient's weight distribution.
5. Adjust the position of the laser light. Position the laser light approximately 7-8 cm
below the greater trochanter where the transverse (Pubic Symphysis) and midline
of the femur intersect.
If you are performing a DualFemur measurement, position the laser light for
the left femur first.
6. To start the measurement, select Start from the New Measurement toolbar
7. Monitor the image to make sure it is correct. Make sure that:
● The Femur image shows the greater trochanter (1), femoral neck (2), and
ischium (3).
4. Select the appropriate scan mode based on the thickness of the femur area.
The scan mode for the femur may be different than the scan mode used for the
AP Spine, based on the patient's weight distribution.
5. Adjust the position of the laser light. The laser light position for a femur
measurement depends on whether you have chosen to perform distal and
proximal scans for AFF.
For AFF measurements of both the distal and proximal femur, position the laser
light so it is centered on the patella.
If you are performing a DualFemur measurement, position the laser light for the
left femur first.
6. To start the measurement, select Start from the New Measurement toolbar
7. Monitor the image to make sure it is correct. Make sure that:
● The Femur image shows the greater trochanter (1), femoral neck (2), and
ischium (3).
13. Select Analyze to proceed to Analysis, or Close to exit the Measurement screen.
Femur/DualFemur Analysis
1. If an image is not already open, select an image file for analysis.
When you open a DualFemur image for analysis, the left and right femur images
are both shown. The active femur has a blue box around its image window. Click
inside an image window to make that femur image the active image. The results
include BMD values for each region of each femur and averages and differences
between femurs. Reference data and trending are available.
2. If necessary, select Imaging from the Analyze toolbar to adjust the image.
3. If necessary, select Points from the Analyze toolbar to adjust point typing.
Bone points Neutral points Tissue points
Do not adjust the point typing unless the program made obvious errors.
4. If you adjust point typing, select Results to view the analysis results based on
your changes.
5. Generally, no adjustments are necessary to ROI placement.
Do not adjust (move, rotate, or size) the Neck ROI unless it is obviously incorrect.
The Neck ROI should be positioned as follows:
● The Neck ROI includes no part of the greater trochanter
● The Neck ROI includes soft tissue on either side of the neck
● The Neck ROI is perpendicular to the femoral neck
● The Neck ROI contains little or no ischium (if the ischium is included in the Neck
ROI, the program automatically assigns the bone within the ischium as Neutral)
is computed using the FRAX model endorsed by the World Health Organization (WHO).
T-scores are based on the NHANES reference values for women aged 20-29 years.
The physician should review local clinical guidelines, and then determine the optimal
FRAX configuration.
FRAX is a trademark of the University of Sheffield Medical School, Centre for Metabolic
Bone Diseases, A World Health Organization (WHO) Collaborating Centre.
Enabling and Configuring FRAX
To enable FRAX, select Tools> User Options > System tab and click FRAX.
FRAX dialog
3. DualFemur measurements automatically select the region (Left or Right) with the
lowest femoral Neck BMD (lowest). You can change this selection by clicking on
the region of choice (Left, Right, or Mean).
4. Select the appropriate FRAX Population from the drop down menu. If the patient's
country is not represented, select the country for which the epidemiology of
osteoporosis most closely approximates the patient's country.
Based on the FRAX model, examples of high risk countries are Denmark and
Sweden. Low risk countries include Lebanon and China.
5. Click the Calculate button.
The 10-year probability of hip fracture and 10-year probability of a major
osteoporotic fracture are displayed.
FRAX 10-Year Fracture Risk Reports
The following FRAX 10-Year Fracture Risk reports are available:
Composer FRAX
DXA reports DualFemur FRAX, Left Femur FRAX, and Right Femur FRAX
(availability based on open exam).
Refer to Creating a Report (193) and DXA Results Reports (191) for more information
on generating reports.
Atypical Femur Fracture Analysis
Atypical Femur Fractures (AFFs) are stress fractures that occur in the femur shaft and
may be accompanied by a focal or diffuse periosteal reaction of the lateral cortex
surrounding the region where the fracture initiated. An area of cortical thickening is
called a “beak”, and the process of the thickening is called “beaking”.
Atypical Femur Fracture (AFF) Analysis displays an image of the entire femur to allow
the user to visualize focal reaction or thickening of the lateral cortex. In addition, the
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software displays quantitative measurements of the cortical width along the femur
shaft, providing the user tools for measuring the size of the cortical width and beak.
These results are available for full length femur images by default. To enable AFF
results for proximal only images, go to Tools > User Options > Analyze tab > Femur
Analysis Options.
When the AFF tab is selected, the lateral and medial cortical bone edges are
highlighted on the image. The cortical width is measured and lateral cortex is analyzed
to locate an area of focal thickening. If a thick area is found, the beak is measured in
millimeters and an arrow points to its location.
Tools are provided to allow the user to inspect cortical widths along femur shaft.
The size of a beak is dependent on its orientation in a two-dimensional DXA
image. The user must use the foot brace to control leg position and can verify
rotation by looking at the prominence of the lesser trochanter on the DXA
scan image. The standard deviation of a beak size measurement is expected
to be 0.5 mm with consistent patient positioning. Clinical measurement
error may vary.
AFF results
The following AFF results are available on the AFF results tab:
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Beaking Index Magnitude of the increase in the cortical width at the location
of localized periosteal reaction in mm
Beaking Index is measured as the distance from inner cortical wall (A) to outer edge of
beak (B) minus the width of cortical wall in areas adjacent to beak (C) in mm.
The first time any exam with Femur AFF is analyzed, the user will be prompted to enter
a threshold to display an arrow where maximum beaking index is located. The arrow
will only appear on the image if the beaking index is greater than this threshold. The
threshold can be adjusted at any time in User Options > Analyze > Femur Analysis
Options.
AFF graphs
The following AFF parameters can be graphed on the AFF results tab:
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Beaking Profile Profile along the femoral shaft of the beaking index in mm
Lateral Cortical Width Profile along the femoral shaft of the lateral cortical width
in mm
Medial Cortical Width Profile along the femoral shaft of the medial cortical width
in mm
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AFF results are found on the AFF Report and Composer field codes are available. See
Create a Report (193) and DXA Reports (191) for more information on generating
reports.
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AHA tab
Upper Neck reference data: Comparison to reference data is available for the
Upper Neck region. Femur upper neck reference data is available for both males
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and females for the following reference populations: USA, Germany, Australia, UK,
Brazil, and Finland. Both young adult and age-matched results are displayed for
Upper Neck. Age-matched adjustments are provided for weight and ethnicity for all
supported populations. The Upper Neck region can be found immediately below
Neck in the region table.
Upper Neck reference data
Lower Neck ROI (indicated in red on the image below) includes the bone below the
neck axis line. This region is automatically determined by the software based upon the
Neck ROI position and the calculated neck axis position.
Lower Neck ROI
Hip Strength
Hip Strength provides an index of hip strength by combining BMD, femur geometry,
age, height, and weight.
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The Hip Strength Index is derived from published information from the Journal of
Bone Mineral Research 1994 article entitled Geometric Structure of the Femoral
Neck Measured Using Dual-Energy X-ray Absorbitometry. The value is not for clinical
diagnosis of disease.
Hip Strength definitions
Strength Strength / stress, where
Index strength = 185 - 0.34(age - 45); Age > 45 years
stress = moment * y / CSMI + force / CSA
moment = d1 * 8.25 * weight * 9.8 (height / 170)1/2 * cos(180° - θ)
force = 8.25 * weight * 9.8 * (height / 170)1/2 * sin(180° - θ)
Buckling y/Cortical Width Neck
Ratio
Section CSMI/y
Modulus
(mm3)
CSMI Cross-sectional moment of inertia
CSA Cross-sectional area
d1 Distance from head center to section of minimum CSMI along neck
axis
d2 Distance along the neck axis from the center of the femoral head to
the neck/shaft axis intersection
d3 Average diameter of the femoral neck
y Distance from the center of mass to the superior neck margin
Alpha (α) Angle of shaft axis with respect to vertical
Theta (θ) Angle of the intersection of the neck and shaft axes
Hip Geometry
Hip Geometry provides information about the structural geometry of the femur.
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Forearm Measurement
1. Put the forearm positioner on top of the pad.
The LUNAR logo should be located near the patient's fingers. The forearm
positioner keeps the patient's forearm from moving during a measurement.
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Use a chair without arms or wheels. Use the same chair for all forearm
measurements to get optimal precision.
iDXA and Prodigy scanners have an option to scan the patient in a non-seated
position with the scan positioner under the forearm (Tools > User Options >
Measure tab). Continue to use the same method of positioning. If previous scans
were done in a seated position, continue to use the same scanning method to
trend data.
3. Place the arm on the positioning board with the palm down with the hand near
the Lunar label (1), and tell the patient to make a loose fist.
4. The red line (2) shows the center of the measurement area. Center the patient's
forearm along this line.
5. The black lines (3) show the boundary of the measurement area. Position the
patient's forearm so that both the radius and the ulna are between these lines.
6. The blue line (4) shows the starting point of the measurement. Position the
patient's forearm so the distal end of the ulna is at this line. This is where you will
position the laser light when you start a measurement.
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7. Attach the Velcro straps over the fist and over the arm immediately below the
elbow.
The straps must be outside the measurement region.
If necessary, move the positioner and the patient's arm so that the laser light
shines in the center of the patient's arm and is aligned with the blue line on the
forearm positioner.
Make sure the patient's elbow makes a 90-degree angle, and make sure the
forearm positioner is straight on the table top. All of the ulna styloid should be
visible.
10. To start the measurement, select Start from the New Measurement toolbar
11. Monitor the image to make sure it is correct. Make sure that:
● The forearm bones are centered and straight
● The forearm is in the center of the image
● The distal end of the ulna (1) is shown near the top of the image
12. If the image is not correct, select Abort, reposition the laser light, and restart
the measurement.
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13. To complete another measurement for the patient, select Set Up from the New
Measurement toolbar.
14. If you have completed measurements for the patient, select Home to move the
scanner arm to the Home position
15. Select Analyze to proceed to analysis or Close to exit the Measurement screen.
Forearm Analysis
1. If an image is not already open, select an image file for analysis.
The results may include a ScanCheck tab. Use ScanCheck
(183) to assist in the analysis of the image and to help you
make corrections where necessary.
2. If necessary, select Imaging from the Analyze toolbar to adjust the image.
3. If necessary, select ROIs from the Analyze toolbar to adjust ROIs.
4. Make sure the forearm ROIs are positioned correctly as follows:
● (1) The Reference line is located at the distal tip of the ulna styloid process
● (2) The UD ROI does not contain the radial endplate
● (3) The vertical lines in the center of the UD and 33% ROIs are located between
the radius and ulna
Forearm ROI positioning
Do not make any changes to the locations of the ROIs unless the program made
obvious errors.
5. Select Length, and make sure the length of the patient’s forearm is correct.
6. Select the Move/Size ROI tool or the Rotate ROI tool and move the Reference Line
to the correct location. All the ROIs move when you move the Reference Line.
7. If the radial endplate is included within the UD ROI, move the UD ROI to just
proximal to the endplate.
8. If you adjust ROIs, select Results to view the analysis results based on your
changes.
9. If necessary, select Points from the Analyze toolbar to adjust point typing.
Do not adjust the point typing unless the program made obvious errors.
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10. If you adjust point typing, select Results to view the new analysis results based
on your changes.
Bone points Neutral points Tissue points
11. Select Save to save changes, or select Close then No if you do not want to save
changes.
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A) The patient’s body is in the center of the scanner table. Use the centerline on
the table as a reference to align the patient.
If a patient is wider than the scan area, the patient can
be positioned for a half body scan (also known as a
MirrorImage scan). In addition to all of the right side of
the body, the entire head and spine should be included
in the scan window.
B) The patient’s hands are turned on sides with thumbs up, palms facing legs and
arms are alongside the patient’s body. If possible, hands should not touch legs.
CoreScan results require that hands do not touch legs and there is a small air gap
(~1 cm) between the arms and torso. Verify that the patient’s arms are within the
scan area lines on the table pad. This hand position will yield optimal results,
especially on heavier patients. Use of this hand position every time the patient
undergoes a Total Body measurement will lead to more consistent results when
trending the patient’s Total Body measurement data over time.
C) Velcro strap.
4. Make sure the patient’s head is approximately 3 cm below the horizontal line
on the table pad.
5. Use the Velcro straps to secure the patient’s knees and feet to prevent movement
during the measurement.
You are not required to adjust the scan arm position for
Total Body measurements.
6. To start the measurement, select Start from the New Measurement toolbar
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8. If the image is not correct, select Abort and reposition the patient.
9. To complete another measurement for the patient, select Set Up from the New
Measurement toolbar.
10. If you have completed measurements for the patient, select Home to move the
scanner arm to the Home position.
11. Select Analyze to proceed to Analysis, or Close to exit the Measurement screen.
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Click the Estimate tool to estimate one side of the body from the other.
Total Body Densitometry Reference Graphs
If NHANES 1999-2004 is selected for the Total Body reference population on the
Reference Data Tab (244) in User Options, the NHANES Total Body Densitometry
reference graph is displayed as shown below.
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The NHANES Densitometry Reference Graph Options dialog lets you change the
NHANES Densitometry reference graph breakpoints and colors. Access these options
in Tools > User Options > Results Display > Reference Graph Options > NHANES
Total Body.
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Results can be set to Z-Score or Centile. There are two sets of editable graph
breakpoints and colors, one for each result type. Select Z-Score or Centile to see a
color control dialog where you can adjust the settings for that result.
The Breakpoints color control has three options:
1. Add/Shift: Add a breakpoint by moving the mouse to an open area between
existing breakpoints. When the pointer changes to a plus sign, click to add a
new breakpoint.
In Centile mode, the range of breakpoints that can be added is 1 to 99, in whole
number increments. In Z-Score mode, the range is -4.0 to +4.0, in 0.1 increments.
Shift (move) an existing breakpoint by moving the pointer to an existing
breakpoint. When the pointer changes to an arrow, drag the selected breakpoint
to the desired level.
When moving breakpoints, you cannot move it past a neighboring breakpoint.
2. Delete: Delete a breakpoint by moving the pointer to an existing breakpoint.
When the pointer changes to an X, click to delete the selected breakpoint.
You must have at least one breakpoint; you cannot delete all breakpoints.
3. Edit Color: To change the colors between breakpoints, move the pointer over a
color area between breakpoints. When the cursor changes to a pen, click to open
a color selection dialog.
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Answering Yes causes the scan to be reanalyzed in the current mode, and answering
No leaves the analysis as it is.
The default scan type (Basic or Enhanced) is set in Tools > User Options > Analyze tab
> Total Body Analysis Options button (see Analyze Tab (242)).
Total Body scans acquired with Small mode only support Enhanced analysis.
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body composition values are useful include chronic renal failure, anorexia nervosa,
obesity, AIDS/HIV, and cystic fibrosis.
A) The patient’s body is in the center of the scanner table. Use the centerline on
the table as a reference to align the patient.
If a patient is wider than the scan area, the patient can
be positioned for a half body scan (also known as a
MirrorImage scan). In addition to all of the right side of
the body, the entire head and spine should be included
in the scan window.
B) The patient’s hands are turned on sides with thumbs up, palms facing legs and
arms are alongside the patient’s body. If possible, hands should not touch legs.
CoreScan results require that hands do not touch legs and there is a small air gap
(~1 cm) between the arms and torso. Verify that the patient’s arms are within
the scan area lines on the table pad.
C) Velcro strap.
2. Select Position from the New Measurement toolbar.
The scanner arm moves to the approximate start position, and a graphic is shown
that gives the correct patient position and measurement start position.
3. Remove the patient’s shoes.
4. Make sure the patient’s head is approximately 3 cm below the horizontal line
on the table pad.
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5. Use the Velcro straps to secure the patient’s knees and feet to prevent movement
during the measurement.
You are not required to adjust the scan arm position for
Total Body measurements.
6. To start the measurement, select Start from the New Measurement toolbar
7. Monitor the image to make sure it is correct.
A correct Total Body image shows the patient's entire body. Make sure the head
(1), feet (2), and arms (3) are shown in the image.
Correct total body image
8. If the image is not correct, select Abort and reposition the patient.
9. To complete another measurement for the patient, select Set Up from the New
Measurement toolbar.
10. If you have completed measurements for the patient, select Home to move the
scanner arm to the Home position.
11. Select Analyze to proceed to Analysis, or Close to exit the Measurement screen.
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3. To print a report, select the Composition report option in the Reports dialog box.
Left Total/Right Total Regions
The option to generate total left and total right regions is located in Tools > User
Options > Analysis tab. Check the option box to enable Left/Right Total Body results.
Half Body/MirrorImage Scan to Estimate Composition
For very wide patients that do not fit within the scan boundaries, it is recommended
that you perform analysis of half of the body, then use the Estimate tool to estimate
one side of the body from the other.
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In this example, only the entire right half of the body fits into the scan area.
Half body (MirrorImage) scan image
Click ROIs, and then click Estimate to estimate one side of the body from the other.
If the Total Body is derived from an estimate from half of the body, (e) appears next to
the Region column in Densitometry and Composition results tables, and next to the
Measured Date column in Trend tables.
Densitometry table with estimated results
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The Android/Gynoid (A/G) ratio is the ratio between the %Fat of the Android (central)
and %Fat of the Gynoid (hip and thigh) regions. The Enhanced Composition report
page displays the Android/Gynoid ratio.
Composition BMI (Body Mass Index)
BMI reference graph is from the World Health Organization's classification. BMI is
shown on the Composition results tab if the BMI user option is enabled. The graph is
intended for adult men and nonpregnant women that are 20 years of age or older.
The BMI is a simple but objective anthropometric indicator of the nutritional status
of the adult population.
The configurable reference graph divisions are:
● Underweight (<18.5 BMI)
● Normal (18.5-24.9 BMI)
● Overweight (25.0-29.9 BMI)
● Obese (30.0 and above)
BMI = Weight in kilograms / (Height in meters)2
Body Composition BMI Graph is available in Composer Reports as an option.
BMI does not distinguish between fat and lean. Therefore, BMI
is not a good indicator of ideal body weight for athletes and
body builders with above average lean muscle mass. In other
words, an athlete with a large muscle mass may have a BMI
in the overweight range, but not be overweight for his/her
body size.
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Results have been validated in a male and female sample population between the
ages of 18 and 90 years with a BMI between 18.5 and 40 excluding pregnant women.
The values are displayed on the CoreScan tab on the Analysis screen.
CoreScan results are found on the Total Body Composition Ancillary Report, and
Composer field codes are available. See Creating a Report (193) and DXA Results
Reports (191) for more information on generating reports.
References:
● Kaul S, Rothney MP, Peters DM, Wacker WK, Davis CE, Shapiro MD and Ergun DL:
Dual-energy x-ray absorptiometry for quantification of visceral fat. Obesity (Silver
Spring) 20:1313-8, 2012
Composition Trending Options
Composition trending tables display the Composition Trend of the region selected
and the Fat Distribution.
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1. The options to change trending graphs are found on the Composition Trend tab
on the Analysis screen:
Composition trending options
● From the Region drop down menu (1), choose the region to trend.
● From the Display menu (2), choose a display option. Options include Absolute
Value, Change vs., Mass (Total, Fat, Lean), Mass (Total, Fat, Lean, TBW), and
Reference.
● If you select Change vs. for the Display option, a single Trend On menu
appears (3). Choose a value from the Trend On menu for Y1 only. This plots
%Change vs Previous or Baseline for Y1.
If you select Absolute Value for the Display option, two Trend On menus
appear (3 and 4). Choose a value from the Trend On menus for both Y1 and Y2.
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In the Report Center for Spine/Femur exams, the Estimated Total Body Exam report
includes a reference graph, trend graph (when applicable), BMI graph, and table that
includes Tissue (%Fat), Tissue (%Lean), and Centile.
Estimated Total Body Composition Limitations
68% of estimated total body %Fat values will be within approximately 3% of the
measured value for males and females. The estimated Total Body %Fat estimates are
only valid for Caucasian and Asian patients. The estimated Android and Gynoid %Fat
estimates are only valid for Caucasian patients. Patient’s age, weight, height, BMI,
and spine and femur measurement values fall must fall within limited ranges (see
tables below for details).
Caucasian Range Limits for Valid Total Body %Fat Estimation Variables
Female Male
Age (yrs) Min 20 20
Max 100 100
Height (cm) Min 130 150
Max 185 200
Weight (kg) Min 40 55
Max 135 125
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Female Male
BMI (kg/ m²) Min 15 18
Max 45 42
Spine %Fat Min 2 2
Max 55 55
Spine Thickness (cm) Min 11 13
Max 27 29
Femur %Fat Min 10 10
Max 50 40
Femur Thickness (cm) Min 10 12
Max 25 22
Predicted Total Body %Fat Min 10 10
Max 60 45
Caucasian Range Limits for Valid Android & Gynoid %Fat Estimation Variables
Female Male
Age (yrs) Min 20 20
Max 100 100
Height (cm) Min 130 150
Max 185 200
Weight (kg) Min 40 55
Max 135 125
BMI (kg/ m²) Min 15 18
Max 45 42
Spine %Fat Min 2 2
Max 55 53
Spine Thickness (cm) Min 11 15
Max 27 28
Femur %Fat Min 10 10
Max 50 40
Femur Thickness (cm) Min 10 12
Max 23 22
Predicted Total Body %Fat Min 10 10
Max 60 45
Gynoid %Fat Min 22 20
Max 62 49
A/G Ratio Min 0.3 0.75
Max 1.25 1.6
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In addition to the above fixed ranges for Total Body, Android, and Gynoid %Fat, the
spine thickness values should fall within limits which vary with BMI which are given in
the equations below (BMI is calculated from the entered height and weight):
● Caucasian Female spine tissue thickness (cm) = -9.014 + 5.214√(BMI) ± 3.8 cm
● Caucasian Male spine tissue thickness (cm) = -6.726 + 5.199√(BMI) ± 3.0 cm
Android and Gynoid %Fat has an additional limitation:
● Spine Thickness / Femur Thickness = 1.46
Asian Range Limits for Valid Total Body %Fat Estimation Variables
Female Male
Age (yrs) Min 20 20
Max 90 90
Height (cm) Min 140 150
Max 180 180
Weight (kg) Min 34 35
Max 90 92
BMI (kg/ m²) Min 14 14
Max 35 31
Spine %Fat Min 5.85 4.79
Max 55 46
Spine Thickness (cm) Min 10 11
Max 21 22
Femur %Fat Min 9 5.85
Max 45 34
Femur Thickness (cm) Min 9 9
Max 17 17
Predicted Total Body %Fat Min 5 5
Max 50 43
In addition to the above fixed ranges, the spine and femur thickness values should
fall within limits which vary with BMI which are given in the equations below (BMI is
calculated from the height and weight entered):
● Asian Female spine thickness (cm): 7.861 + 0.06798*BMI1.5 ± 5.54
● Asian Female femur thickness (cm): 0.07868 + 2.669*√(BMI) ± 3.39
● Asian Male spine thickness (cm): -8.958 + 5.313√(BMI) ± 6.63
● Asian Male femur thickness (cm): -2.633 + 3.277√(BMI) ± 4.10
Composition Color Mapping
iDXA Total Body images can be color mapped.
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1. Click the Color Mapping button to the left of images in the Analysis screen
to display color mapping.
Color mapped image
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Default tissue mapping colors are red, yellow, and green, where:
● Green represents an area of low level %Fat
● Yellow represents an area of medium level %Fat
● Red represents an area of high level %Fat
These colors can be customized under Tools > User Options > Image > Image
Colors.
Composition Color Coding
Color Coding is available on total body scans with iDXA, or Prodigy enhanced or basic
analysis.
1. Click the Color Coding button to the left of images in the Analysis screen
to display color coding.
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These colors can be customized under Tools > User Options > Image > Image
Colors (see Image Tab (246)).
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Measurement System can be set to Metric or English. This setting affects the
Composition results (not Densitometry).
Results can be set to Z-Score or Centile. There are two sets of editable graph
breakpoints and colors, one for each result type. Select Z-Score or Centile to see a
color control dialog where you can adjust the settings for that result.
The Breakpoints color control has three options:
1. Add/Shift: Add a breakpoint by moving the mouse to an open area between
existing breakpoints. When the pointer changes to a plus sign, click to add a
new breakpoint.
In Centile mode, the range of breakpoints that can be added is 1 to 99, in whole
number increments. In Z-Score mode, the range is -4.0 to +4.0, in 0.1 increments.
Shift (move) an existing breakpoint by moving the pointer to an existing
breakpoint. When the pointer changes to an arrow, drag the selected breakpoint
to the desired level.
When moving breakpoints, you cannot move it past a neighboring breakpoint.
2. Delete: Delete a breakpoint by moving the pointer to an existing breakpoint.
When the pointer changes to an X, click to delete the selected breakpoint.
You must have at least one breakpoint; you cannot delete all breakpoints.
3. Edit Color: To change the colors between breakpoints, move the pointer over a
color area between breakpoints. When the cursor changes to a pen, click to open
a color selection dialog.
Click the Restore Defaults button to restore all default breakpoints and colors (Centile
and Z-Score).
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Metabolic Information
The following are Composer field codes and are on the Total Body Composition
Ancillary DXA Report:
● Resting Metabolic Rate (RMR)
● Relative Skeletal Muscle Index (RSMI)
● Total Body Water (TBW)
● Intracellular Water (ICW)
● Extracellular Water (ECW)
The above metabolic information is displayed on the Metabolic tab on the Analysis
screen for total body exams. You can configure the display of this information in Tools
> User Options > Results Display > Metabolic Options.
RMR and RSMI are available for patients age 18 and over.
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Studenski SA, Peters KW, Alley DE et al (2014) The FNIH sarcopenia project: rationale,
study description, conference recommendations, and final estimates.
J Gerontol A Biol Sci Med Sci 69(5):547–558
Advanced Mode
Check Advanced to display the following options:
Abbreviation and Name: Enter an abbreviated and long name for the new sarcopenia
definition.
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Test button: Display the Sarcopenia Test dialog to allow data input for testing the
classification formula.
After completing the sarcopenia definition, use the Sarcopenia Test dialog to test
data inputs. Enter values and select Calculate to ensure your sarcopenia definitions
perform as expected.
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Sarcopenia Calculator
The Sarcopenia Calculator is available for total body analysis when the patient meets
the minimum sarcopenia definition age.
Sarcopenia Calculator
software and are not editable. The calculator button can be used to calculate
Gait Speed in m/s.
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Sarcopenia Reports
Report (DXA) Sarcopenia is available on the Reports Center dialog to show either
current exam results (non-trending) or trend results based on the Report Center Trend
checkbox.
Positioner B should be placed on top of the spine strap (1) and against the back
rail of the table (2).
The lateral positioner and the instructions below are intended to position the
lumbar spine straight and parallel to the scanner table.
2. Set a pillow on the table for the patient's head.
3. Position the patient's knees toward the chest until the lower back and both
shoulders are flat against the lateral positioner.
4. Make sure the patient's spine is parallel to the scanner table.
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Positioner B:
● Pull the compressor strap over the patient's torso and secure it to the back of
the positioner. Make sure the strap does not hang over the back edge of the
scanner.
● Set a foam wedge between the patient's thighs and the bottom of the
positioner. Set a second wedge between the patient's knees, and set a third
wedge below the bottom knee. Make sure the patient's back is flat against the
positioner and adjust the strap so the patient does not roll forward during
the measurement.
● Adjust the foam wedge between the back of the patient's thighs and the
positioner to hold the knees in place during the measurement.
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9. Use the graphic shown on the New Measurement screen to adjust the position of
the laser light. Position the Laser Light at the top of the patient's iliac crest.
Lateral Spine measurement
Adjust as follows:
● End in L1
● All posterior elements visible
● 2.5+ cm tissue
● Start in sacrum so that all of L5 is visible
10. To start the measurement, select Start from the New Measurement toolbar
11. Monitor the image to make sure it is correct. Make sure that:
● The image starts in the sacrum so that all of L5 is visible (1)
● At least 2.5 cm of soft tissue is shown on the anterior side of the vertebrae (2)
● The image ends in L1 (3)
● All of the posterior elements appear in the image (4)
● The edge of the positioner may appear in the image; this is not a problem (5)
Correct Lateral Spine image
12. If the image is not correct, select Abort, reposition the laser light, and restart
the measurement.
13. To complete another measurement for the patient, select Set Up from the New
Measurement toolbar.
14. If you have completed measurements for the patient, select Home to move the
scanner arm to the Home position
15. Select Analyze to proceed to Analysis, or Close to exit the Measurement screen.
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4. To invert the contrast of the images, go to Tools > User Options > Images tab,
and check the option to Invert Images.
5. Select Points from the Analyze toolbar to adjust point typing.
Do not adjust the point typing unless the program made obvious errors.
Lateral bone points Lateral neutral points Lateral tissue points
6. Select Results to view the new analysis results based on your changes.
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7. Select Save to save changes, or select Close then No if you do not want to save
changes.
Positioner B should be placed on top of the spine strap (1) and against the back
rail of the table (2).
The lateral positioner and the instructions below are intended to position the
lumbar spine straight and parallel to the scanner table.
2. Set a pillow on the table for the patient's head.
3. Position the patient's knees toward the chest until the lower back and both
shoulders are flat against the lateral positioner.
4. Make sure the patient's spine is parallel to the scanner table.
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Positioner B:
● Pull the compressor strap over the patient's torso and secure it to the back of
the positioner. Make sure the strap does not hang over the back edge of the
scanner.
● Set a foam wedge between the patient's thighs and the bottom of the
positioner. Set a second wedge between the patient's knees, and set a third
wedge below the bottom knee. Make sure the patient's back is flat against the
positioner and adjust the strap so the patient does not roll forward during
the measurement.
● Adjust the foam wedge between the back of the patient's thighs and the
positioner to hold the knees in place during the measurement.
The scanner arm moves to the approximate start position, and a graphic is shown
that gives the correct patient position and measurement start position.
7. Adjust scan length or width as needed. LVA Morphometry scan length can be
increased to 55.4 cm.
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8. For patients that are unable to rest on their left side for LVA scanning, select the
Reverse box to allow the patient to rest on their right side and reverse the scan
arm direction.
9. Use the graphic shown on the New Measurement screen to adjust the position of
the laser light. Position the Laser Light at the top of the patient's iliac crest.
LVA Morphometry measurement
Adjust as follows:
● End near T4
● All posterior elements visible
● 2.5+ cm tissue
● Start in sacrum so that all of L5 is visible
10. To start the measurement, select Start from the New Measurement toolbar
11. Monitor the image to make sure it is correct. Make sure that:
● The image starts in the Sacrum so that all of L5 is visible
● At least 2.5 cm of soft tissue is shown on the anterior side of the vertebrae
● The image ends near T4
● All of the posterior elements appear in the image
The edge of the positioner may appear in the image. This is not a problem.
12. If the image is not correct, select Abort, reposition the laser light, and restart
the measurement.
13. To complete another measurement for the patient, select Set Up from the New
Measurement toolbar.
14. If you have completed measurements for the patient, select Home to move the
scanner arm to the Home position
15. Select Analyze to proceed to Analysis, or Close to exit the Measurement screen.
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3. To invert the contrast of images, navigate to Tools > User Options > Images and
check the Invert Image option.
LVA image Inverted LVA image
4. Select the desired analysis type under Tools > User Options > Analyze tab and
select the Morphometry options.
Morphometry Options dialog
5. Enable the Morphometry Wizard, then follow the steps for the analysis type
selected.
● Create ROIs on Request (151)
● Automatically create Reference ROIs when needed (152)
● Automatically create ROIs for T8-L4 when opening exam (152)
6. The software automatically assigns the Morphometry deformity label for all
analysis types.
7. To change a Morphometry deformity label, click the Deformity icon and then
click on the vertebra of interest.
Only use this tool to override automated morphometry
analysis.
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9. From the list of deformities, select the desired deformity indication label.
Icon Deformity label
Mild Wedge
Moderate Wedge
Severe Wedge
Mild Biconcavity
Moderate Biconcavity
Severe Biconcavity
Mild Compression
Moderate Compression
Severe Compression
When you assign a deformation to a vertebra, the symbol for the deformation
appears next to the ROI label in the results table in the Analysis window.
10. Select Save to save changes, or select Close then No if you do not want to save
changes.
Create ROIs on Request (Recommended)
1. Click on a vertebra that appears deformed. Click as close to the center of the
vertebra as possible.
The Morphometry Wizard window opens.
2. Verify the ROI label and positioning and make appropriate changes if necessary.
Make sure each vertex of the ROI is centered in the vertebral endplate. Redo the
auto-endplate finding by double-clicking in the exact center of the vertebra.
3. Click Next.
4. Click L4 in the Morphometry Wizard window and click Next.
5. Verify the heights of L2, L3, and L4 and make changes as needed.
These vertebrae are used as a reference data stature adjustment. If any of these
vertebrae are deformed, it is not used in the stature adjustment.
6. Click Finish.
7. To analyze additional vertebrae, repeat the steps above and click Finish.
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With the Morphometry Wizard enabled, the following tools become available after
clicking a target ROI:
Icon Tool Description
Move/Size ROI Click the Move / Size ROI tool, and then
click and drag ROI or edges as needed.
Rotate ROI Click the Rotate ROI tool, and then click
and drag near the corner of (but inside)
the ROI to rotate it.
Adjust Vertices Click the Adjust Vertices tool, and then
click and drag vertices as needed.
Position Reference ROIs This tool is available on LVA scans after
reference vertebrae are identified, and
is used to reposition the reference ROIs.
Label ROI From the drop-down menu, select the
correct vertebra to label the ROI.
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Z-Scores mode
● Percent Reduction (%) mode uses P/A ratio to determine compression, A/P ratio to
determine wedge, and M/P ratio to determine biconcavity deformities.
Percent Reduction mode
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Trend Graph Options are set in Tools > User Options > Trending > Trend Graph
Options.
Trend Table Options are set in Tools > User Options > Trending > Trend Table Options.
Options to trend Morphometry on DXA reports are set in Tools > User Options >
Reports > Morphometry Report Options. You can select multiple trend results for a
single report.
Composer Trending options are configured in Composer.
The lateral positioner and the instructions below are intended to position the
lumbar spine straight and parallel to the scanner table.
2. Set a pillow on the table for the patient's head.
3. Position the patient's knees toward the chest until the lower back and both
shoulders are flat against the lateral positioner.
4. Make sure the patient's spine is parallel to the scanner table.
5. Complete patient positioning:
● Place a pillow under the patient's head.
● Set a foam wedge below the bottom knee and between the knees for comfort.
● Make sure the patient's back and hips are flat against the positioner.
● Patient's arms should be 90 degrees from the chest.
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The scanner arm moves to the approximate start position, and a graphic is shown
that gives the correct patient position and measurement start position.
7. Select the Include Cervical Spine box.
8. Adjust scan length or width as needed. LVA Spine Geometry scan length should be
increased to 69.5 cm.
9. For patients that are unable to rest on their left side for LVA scanning, select the
Reverse box to allow the patient to rest on their right side and reverse the scan
arm direction.
10. Use the graphic shown on the New Measurement screen to adjust the position of
the laser light. Position the Laser Light at the top of the patient's iliac crest.
LVA Spine Geometry measurement
Adjust as follows:
● End near C1
● All posterior elements visible
● 2.5+ cm tissue
● Start in sacrum so that all of L5 is visible
11. To start the measurement, select Start from the New Measurement toolbar
12. Monitor the image to make sure it is correct. Make sure that:
● The image starts in the sacrum so that all of L5 is visible
● At least 2.5 cm of soft tissue is shown on the anterior side of the vertebrae
● The image ends near C1
● All of the posterior elements appear in the image
The edge of the positioner may appear in the image. This is not a problem.
13. If the image is not correct, select Abort, reposition the laser light, and restart
the measurement.
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14. To complete another measurement for the patient, select Set Up from the New
Measurement toolbar.
15. If you have completed measurements for the patient, select Home to move the
scanner arm to the Home position
16. Select Analyze to proceed to Analysis, or Close to exit the Measurement screen.
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4. Use the graphic shown on the New Measurement screen to adjust the position
of the laser light. Position the laser light approximately 5 cm below the patient's
navel.
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3. Click the vertebra you want to analyze, and select a label for the vertebra.
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5. To start the measurement, select Start from the New Measurement toolbar
6. Monitor the image to make sure it is correct.
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7. If the image is not correct, select Abort, reposition the laser light, and restart
the measurement.
8. To complete another measurement for the patient, select Set Up from the New
Measurement toolbar.
9. If you have completed measurements for the patient, select Home to move the
scanner arm to the Home position
10. Select Analyze to proceed to Analysis, or Close to exit the Measurement screen.
Rotate ROI Click Rotate ROI, and then click and drag near
the end of the ROI.
Delete ROI Click Delete, and then click the target ROI.
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Label ROI Select the ROI to relabel, then click Label ROI.
Choose the desired label from the menu.
Angle After at least two ROIs have been added, the
Angle tool is activated. Click Angle to change
angle configurations.
Show/Hide ROIs Click to show or hide ROIs.
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Pediatric Measurement
Measurement procedures are the same as the procedures for adult patients. Refer to
the appropriate topic, based on the type of pediatric measurement you are performing:
● For AP spine, refer to AP Spine Measurement (86).
● For femur, refer to Femur/Dual Femur Measurement (91).
● For total body, refer to Total Body Measurement (114).
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Results may be affected if the patient moves during the scan. When scanning infants,
it may be helpful to swaddle the child in a blanket to avoid excessive motion during
the scan. Be sure the blanket is thin and made of cotton, because other materials may
appear in the scan image and lead to incorrect results.
Pediatric Analysis
1. If an image is not already open, select an image for analysis.
Pediatric analysis procedures are the same as the procedures for adult patients.
Based on the type of pediatric analysis you are performing, refer to the appropriate
topic as well as the information in the sections below:
● For total body, refer to Total Body Analysis (116)
● For AP spine, refer to AP Spine Analysis (89)
● For femur, refer to Femur/Dual Femur Analysis (96)
Pediatric Total Body Analysis
Pediatric Total Body provides reference data for US (Lunar), US (BMDCS), US (NHANES
1999–2004), China, Asia, and European populations.
The BMD of the head dominates the Total Body BMD in children. To omit the head
from Total Body results, select Tools > User Options > Analyze > Total Body Analysis
Options. Check the Total Body Less Head (TBLH) option and click OK
Select or Omit Head Region on DXA Reports
To select regions or omit the head ROI on DXA reports, follow these steps.
1. Select Tools > User Options > Reports tab.
2. Click the Report Regions button.
3. On the Total Body tab, select TBLH from the Available list on the left.
4. Click Add.
The selected ROI is added to the Selected list on the right.
5. Select the Composition tab and repeat the same steps to add TBLH ROI to the
Composition Report.
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Skeletal Age and Pubertal Stage information is entered in the Patient Information
screen.
Bone Size Assessment:
● Height for Age (Centile)
● BMC for Bone Area (Centile)
● Bone Area for Height (Centile)
Lean Mass Assessment:
● LBM (lean body mass) for Height (Centile)
● BMC for LBM (Centile)
Pediatric Growth Indices are included on the Total Body Ancillary report page.
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Hand Measurement
1. Place the patient in a chair next to the scan table.
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2. Have the patient place the hand flat on the table, 2 cm from the line on the table
pad, with the thumb and fingers together.
Use a chair without arms or wheels. Use the same chair for all hand
measurements to get optimal precision.
Seated hand scan
iDXA and Prodigy scanners have an option to scan the patient in a non-seated
position (Tools > User Options > Measure tab). Continue to use the same method
of positioning. If previous scans were done in a seated position, continue to use
the same scanning method to trend data.
Non-seated hand scan
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4. Use the graphic shown on the New Measurement screen to adjust the position of
the laser light. Position the laser light in the center of the wrist, adjacent to the
ulna styloid. Be sure all of the ulna styloid is visible.
5. To start the measurement, select Start from the New Measurement toolbar.
6. Monitor the image to make sure it is correct. Make sure that:
● The scan proceeds past all fingertips
● All of the ulna styloid is visible
7. If the image is not correct, select Abort and reposition the patient.
8. To complete another measurement for the patient, select Set Up from the New
Measurement toolbar.
9. If you have completed measurements for the patient, select Home to move the
scanner arm to the Home position.
10. Select Analyze to proceed to Analysis, or Close to exit the Measurement screen.
Hand Analysis
1. If an image is not already open, select an image for analysis.
2. Select Imaging from the Analyze toolbar to adjust the image.
3. Select ROI is from the Analyze toolbar to adjust ROIs.
4. Make sure the hand ROIs are positioned correctly as follows:
● The enclosed area includes the entire hand to the tips of the fingertips and
ends at the ulna styloid process
● The ROI includes the carpal bones, but not the ulna or radius
5. Select the Move ROI tool or the Move Vertex tool to adjust the edges of the
region of interest.
● Select Move ROI to move the ROI edges. Do not move the lines unless they
are obviously incorrect.
● Select Move Vertex to move the vertices of the ROI.
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6. If necessary, select Points from the Analyze toolbar to adjust point typing.
Hand bone points Hand neutral points Hand tissue points
not adjust the point typing unless the program made obvious errors.
7. If you adjust point typing, select Results to view the new analysis results based
on your changes.
8. Select Save to save changes, or select Close then No if you do not want to save
changes.
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4. The patient's arms must be crossed over the chest, away from the side of each hip.
5. Place the foam knee positioner under the knee of the leg to be scanned, with the
tapered end toward the patient's thigh.
6. Strap the foot of the leg to be scanned to the vertical side of the foot brace.
The leg should be in a neutral position, NOT rotated as in the femur scan.
7. Position the leg so the femoral shaft and implant are parallel with the centerline
on the scan table.
8. Use the graphic on the New Measurement screen to adjust the position of the
laser light.
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9. Position the laser light mid-thigh, approximately 3-4 cm below the implant tip.
10. Select Start from the New Measurement toolbar to start the measurement.
11. Monitor the image to make sure:
a. (1) The scan is initiated 3-4 cm below the implant tip
b. (2) The femoral shaft and implant are perpendicular to the scan path
c. (3) The scan continues 2-3 cm above the greater trochanter
Correct orthopedic hip image
12. If the image is not correct, select Abort, reposition the laser light, and restart
the measurement.
13. To complete another measurement for the patient, select Set Up from the New
Measurement toolbar.
14. If you have completed measurements for the patient, select Home to move the
scanner arm to the Home position.
15. Select Analyze to proceed to Analysis, or Close to exit the Measurement screen.
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4. You can toggle between Standard Gruen and Extended Gruen zones on the
ROIs screen.
By default, the Gruen icon is selected and all ROIs are active. This allows you to
move all regions at the same time. However, you can move each zone individually,
if desired.
Standard Gruen zones Extended Gruen zones
5. Verify that the ROIs and implant length are correctly identified.
The tools shown below are available on the ROIs screen: Click the ROIs tool
to view these options:
● Move/Size: This option lets you select and adjust a single Gruen zone.
● Ruler: This option lets you measure the implant length. Click an endpoint of
the ruler ROI and move it to the desired location. The ruler should extend from
the implant tip to the shoulder of the implant. The Gruen Zones are positioned
vertically based on the implant length.
● Length: The Length tool lets you modify the length of the implant. The software
automatically calculates a length based on the automated ruler measurement.
The Length tool also includes a Find button which searches for the implant
edges based on the ruler position.
It is recommended that the top of Gruen zones 1 and 7 align with the shoulder of
the implant.
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5. The patient's arms must be crossed over the chest, away from the side of each hip.
6. Place the foam knee positioner under the knee of the leg to be scanned, with the
tapered end toward the patient's thigh.
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7. Strap the foot of the leg to be scanned to the vertical side of the foot brace.
The leg should be in a neutral position, NOT rotated as in the femur scan.
8. Position the leg so the kneecap is straight up and the leg is parallel with the
centerline on the scan table.
9. Use the graphic on the New Measurement screen to adjust the position of the
laser light.
10. Position the laser light mid-shin, approximately 10 cm below the patella.
11. Select Start from the New Measurement toolbar to start the measurement.
12. Monitor the image to make sure:
a. (1) The scan is initiated 10 cm below the patella
b. (2) The tibia and femur are perpendicular to the scan path
c. (3) The scan continues 10 cm above the patella
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13. If the image is not correct, select Abort, reposition the laser light, and restart
the measurement.
14. To complete another measurement for the patient, select Set Up from the New
Measurement toolbar.
15. If you have completed measurements for the patient, select Home to move the
scanner arm to the Home position.
16. Select Analyze to proceed to Analysis, or Close to exit the Measurement screen.
Do not adjust the point typing unless the program made obvious errors.
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7. If you adjust point typing, select Results to view the new analysis results based
on your changes.
8. Select Save to save your changes, or select Close then No if you do not want
to save your changes.
The expected precision for knee BMD is 4-5% %CV depending on the size of the
ROI. Inspect each knee image and adjust points manually for optimal typing of
implant, bone, and soft tissue areas to obtain accurate BMD results.
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● (1) Head: The Head cut is located immediately below the chin.
● (2) Left and right arm: Both arm cuts pass through the arm sockets and are
as close to the body as possible. Ensure the cuts separate the hands and
arms from the body.
● (3) Left and right forearm: Both forearm cuts are as close to the body as
possible and separate the elbows and forearms from the body.
● (4) Left and right spine: Both spine cuts are as close to the spine as possible
without including the rib cage.
● (5) Left and right pelvis: Both pelvis cuts pass through the femoral necks and
do not touch the pelvis.
● (6) Pelvis top: The Pelvis Top cut is immediately above the top of the pelvis.
● (7) Left and right leg: Both leg cuts separate the hands and forearms from
the legs.
● (8) Center leg: The Center Leg cut separates the right and left leg.
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4. If necessary, select ROIs and the Move Vertex tool (shown when you select ROIs).
Adjust the cut itself or select a vertex to adjust the cut position.
● Select the Move Vertex tool to position ROI vertices. Adjust the cut itself or
select a vertex to adjust the cut position.
● Vertex: Click on a vertex, then drag the cursor.
● Cut: Click on a cut (not a vertex), then drag the cursor.
5. Select Results to view the analysis results.
6. If necessary, select Points to examine point typing.
Do not adjust the point typing unless the program made obvious errors.
7. Use the Adjust Threshold tool if necessary to adjust the threshold of the tissue
and bone point typing.
8. If you adjust point typing, select Results to view the analysis results based on
your changes.
9. Select Save to save your changes, or select Close and then No if you do not want
to save your changes.
Small Animal Body Composition
Body Composition is part of the Small Animal Body analysis if you purchased the Body
Composition option. The program reports lean and fat tissue quantities.
Composition results are shown on the screen when you select the Composition tab
in the Analyze window. The program prints a Composition report if you select the
Composition report option in the Reports dialog box.
Use the cut positions to define the tissue regions. Adjust cuts as necessary to include
all of the tissue in the appropriate regions. Be very careful to separate the arm regions
from the tissue in the hips and thighs.
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Custom Analysis
Using custom analysis, you can create custom ROIs for image files. Custom Analysis
results are given in BMD, BMC, Area only. Reference data is not available.
Custom Analysis results are to be used for investigation purposes only.
1. Select an image file for analysis.
2. Select Imaging from the Analyze toolbar.
3. Adjust the image as necessary.
4. Select Custom from the Analyze pull-down menu.
5. Select ROIs from the Analyze toolbar.
6. Use the Custom Analysis tools (180) to create and adjust ROIs.
7. Select Results to view analysis results for each ROI created.
8. Select Save to save your changes, or select Close then No if you do not want
to save your changes.
Copy Selected ROI Click to copy the selected ROI onto the
current image.
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Custom ROIs
Use the tools given below to perform special operations with custom ROIs.
To copy an ROI from one image to another, select the ROI(s) on the source image
and select the Save Custom ROI Template button. Give the ROI template a name
and select OK. Then select the destination image and select the Open Custom ROI
Template button. Select the template with the name you chose and press OK.
The tools are shown in the Analyze toolbar at the top of the Analyze window after
you select ROIs.
Icon Tool Description
Set ROI Size Click to set the selected ROI's size to
specific dimensions.
Precision Calculator
This section contains recommendations to assist in calculating the facility's DXA
precision error.
If you need to acquire scans for your precision study, be aware that local regulatory
policies often apply to such studies. Please consult the appropriate regulatory body
for more information.
The International Society for Clinical Densitometry (www.iscd.org) is a good resource
for information on precision and bone densitometry.
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Precision Wizard
A Precision Wizard tool is available to assist the technologist in generating results from
the completed Precision Calculation study without additional spreadsheet tools.
1. Select Tools > User Options > Trending > Precision Calculator.
2. Select the Confidence Interval (95% is recommended).
3. Click the Wizard button.
4. Check one option:
● Use two scans per patient (30 patient minimum).
● Use three scans per patient (15 patients minimum).
5. Select the scan Sites and select the Regions to be evaluated.
You can select multiple items by holding the Ctrl key while clicking items.
6. Select the patients to include and click Next.
7. Select Next.
● If the selection does not meet the minimum number of patients, a warning
appears.
● If the selection meets the minimal requirements, a progress bar appears.
The Results tab is displayed, where each numbered tab represents a data set. If
two scans of 30 patients were done, only two numbered tabs are shown.
Results:
● BMD= Average BMD
● SD = Standard Deviation. This is the Precision Error in g/cm2.
● CV = Coefficient of Variation = SD / Mean in percent
● LSC = Least Significant Change at 95% Confidence Interval
8. At the bottom of the window, choose an output option:
● Select Export to save the results as a TXT file.
● Select Report to open the default printer window.
● Select Apply to apply the adjustment to the current database.
If Apply is selected, the SD of the precision study is included in the precision
footnote on the DXA report and used to calculate significant change for trend
results.
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ScanCheck
ScanCheck (formerly known as CAD or Computer-Assisted Densitometry) assists the
user in detecting Spine, Femur, Forearm and Total Body abnormalities. ScanCheck
provides guidelines to minimize operator error through identification of potential
measurement and/or analysis errors. When potential anomalies are identified, helpful
instructions are displayed as well as multimedia help.
Apply your own knowledge and judgment to determine if there are any potential
problems with the image measurement or analysis.
When the ScanCheck tab is active, the identification of artifacts, incorrect analysis,
etc., is displayed to the right of the analyzed image. The ScanCheck tab gives the
technologist a checklist of items to confirm and/or correct during the analysis. The tab
includes a series of Yes/No questions with space for comments. Any ScanCheck item
can be disabled in Tools > User Options > ScanCheck tab.
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ScanCheck Checklist
The ScanCheck checklist organizes ScanCheck items into three categories - Measure,
Analyze, Anatomy. Use these categories to analyze the image and make corrections
where necessary.
Click a ScanCheck warning to display a dialog with further instruction for correcting
the specific ScanCheck warning.
For AP Spine-Measure, the following items are verified:
● Scan mode is correct for patient thickness
● Spine is aligned with the centerline of the image
Example: ScanCheck is indicating a potential problem.
The wrong scan mode may have been selected for this patient's thickness.
Recommendation:
Consider rescanning the patient using the proper scan mode based on patient
thickness.
Hyperlinks are available for all ScanCheck indications with the yellow exclamation
point.
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Adjustable Thresholds
AP Spine
AP Spine Adjustment
ScanCheck
Heading
AP Spine Measure Spine does not appear to be aligned properly.
Angle threshold (degrees): 0-90
AP Spine Analysis Scan was started too low.
Scan Start Threshold (mm): 5.0-200.0
Scan was stopped too late.
Scan End Threshold (mm): 5.0-200.0
Bone area is substantially different from previous scan.
Bone area threshold (%): 0-100
AP Spine Anatomy Unusual high density areas detected.
Detection Sensitivity: 1.0-10.0
T-Score for an individual vertebra shows an unusual variation from
the L1-L4 T-Score.
Average T-Score variation threshold: 0.0-5.0
T-Score for at least one vertebra shows an unusual variation from the
T-Score of an adjacent vertebra.
Adjacent T-Score variation threshold: 0.0-5.0
T-Score for at least one vertebra shows an unusual variation from the
T-Score of another vertebra. T-Score variation threshold: 0.0-5.0
Unusual spine curvature was detected.
Angle (Cobb) threshold (degree): 0-90
Femur
Femur ScanCheck Adjustment
Heading
Femur Measure Femur shaft does not appear to be aligned properly.
Angle threshold (degree): 0-90
Forearm
Forearm ScanCheck Adjustment
Heading
Forearm Measure Forearm does not appear to be aligned properly.
Angle threshold (degrees): 0-90
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6
Move Scans
The Move option lets you move image files/exams from one patient record to another.
1. Select the image file you want to move.
Select more than one file by holding down the Ctrl key as you select files.
2. Select Move from the Directory toolbar.
3. Select the patient record to which you want to move the file.
If the patient record is located in a different database, select Change Database.
4. Select Next.
5. Select whether to replace the patient's information in the image file(s) you are
moving with the patient information you are moving the image file(s) to.
6. Select Finish.
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3. Click OK.
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7
Reports
There are two types of reports:
● DXA Reports
● Composer Reports
DXA Reports
DXA reports contain data used by the physician for diagnosis. Each DXA report
uniquely identifies the patient and includes important information about the patient,
the DXA exam, and your product’s configuration. DXA reports can be modified, but
most of the information on the report is required for safe and effective use of product.
Modifications to the data or patient demographics in these
reports may change the patient diagnosis. Contact your local
GE representative if you have questions before modifying
reports or using advanced reporting features.
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Composer Reports
Composer reports contain physician-generated assessments and recommendations
based on data from the densitometer and the patient’s demographics, which can
assist the physician in communicating scan results to the patient and the patient’s
referring physician. Composer reports can be modified to facilitate communication.
Modifications to the data or patient demographics in these
reports may change the assessments and recommendations.
Contact your local GE representative if you have questions
before modifying reports or using advanced reporting
features.
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Report Center
From the Report Center, you can create and send reports to one or more selected
destinations, such as a printer or an e-mail account.
To access the Report Center, open an exam and click the Reports button on the
Analysis toolbar.
Create a Report
1. Open an analyzed exam.
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3. Under Select New Reports, select the check box next to each report you want to
create. If a report is not listed, you can use the Manage Reports window to add
more reports. For more information, refer to the Select Additional Reports (195)
section.
4. Change the report settings as necessary:
● Select Trending to enable trending on multiple exams.
● Click Open/Edit to preview or edit the selected report.
5. Configure the Destination and the number of Copies to print or send. You can
select more than one destination if desired.
Available destination options are Printer, Print-a-FAX, FAX, DICOM, HL7 and
Email. To send reports to these destinations, your organization must have the
appropriate equipment installed and have purchased the appropriate features
with enCORE.
If you send reports to the selected destinations often, click Set as Default. The
next time you open the Report Center, the destinations will be pre-selected for you.
6. Select Advanced to access additional options. HIPAA Secure Report, when
enabled, hides patient identifying information (name, ID, etc.) on any exam report.
7. Select Print/Send to print or send the selected reports. To cancel without printing
or sending, click Close.
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4. Select the report you want to be available. If the report is not listed, click Browse
and navigate to the appropriate style sheet folder. Delete will move highlighted
reports to the recycle bin. Restore System Reports will restore default system
reports. Custom reports will not be restored.
5. Choose Show only selected reports matching current exam content to only
show reports that will give results for the open exam (e.g., femur reports for
femur exams) or choose Show all selected reports to show all reports in the
Report Center.
6. Click Close to return to the Report Center. Verify that the report appears in the
Select New Report list as expected.
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4. Select the sites and assessment category types to be included on the report. The
site, type of assessment, and value for the site (region) are used to determine the
text for the assessment, recommendation, and follow-up.
You can configure enCORE to automatically select assessment sites, and you can
manually override the auto-selected sites:
a. Click Auto-Select.
In the Assessment Auto-Select window, configure how enCORE uses the
T-Score (Young Adult) and Z-Score (Age-Matched) values to automatically
select the assessment sites.
b. Click OK to return to the Assessments window.
Check marks appear for the assessment sites that enCORE automatically
selected.
c. If desired, you can manually override the auto-selected sites by clearing or
selecting the check boxes as needed.
5. Click OK to finish and return to the Report Center.
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4. Click New. Define the conditions under which certain reports should be selected.
5. Define as many rules as needed. Click Move Up and Move Down to organize the
list of rules in the order that the system should evaluate them.
6. If ISCD Official Positions are turned ON in Tools > User Options > Systems, the
Apply ISCD Rules check box is present. Selecting this box will select a specific
report for post-menopausal women and men over 50 years and a different report
for pre-menopausal women and men under 50 years. Click the Select ISCD
Reports button to configure ISCD reports.
7. Click OK to return to the Report Center.
8. Click Close to finish.
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Style Sheets
enCORE software includes a style sheet designer that lets you create a personalized
physician report. You can create a new style sheet or edit one of the style sheets
provided.
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The style sheet editor works in a similar manner to any word processor with options
such as cut, copy, paste, and header/footer.
You can modify the sequence of assessments, comments, etc., and insert images and
tables in the report for easy editing and viewing.
You can open a default style sheet included with the software, make the necessary
modifications specific to your facility, and save the style sheet under a different name.
Open Document
Print (Ctrl+Shift+P)
Edit/Insert Field
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Icon Item
Close Report
Undo
Redo
Paste Text
Subreports
You can create style sheet subreports that can be inserted into multiple style sheets.
Subreports allow you to share common report sections across many style sheets, such
as a header, footer, or sections that may be enabled under certain conditions.
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Assessment Editor
1. Select Composer menu > Assessment Editor.
The Assessment Editor window is shown. The assessment categories are shown
on the left side of the window and the assessment graph is shown on the right.
The assessment graph is divided into sections called assessment boxes. The
program uses these boxes to assign an assessment to the patient's results. The
assessments that are appropriate for the patient's results are included.
2. Select the Category tab.
Select New to create a site-specific, type-specific, or gender-specific category.
Select Edit to change a category or Delete to remove one.
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4. Select the box for which you want to edit an assessment, recommendation, or
follow-up.
The current assessment, recommendation, and follow-up for that box is shown
on the left side of the window.
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7. Edit the Recall Date as desired. Select the Recall option in either year(s) or
month(s).
The Composer Report can automatically add the Recall Date indicating the
recommended return appointment based on the measurement date and what
has been set up in the Assessment Editor screen.
8. Select the Breaks tab.
The Breaks tab in the Assessment Editor window lets you change the assessment
cutoffs by adding or removing the lines that define the boxes.
a. Add or remove break lines:
● To add a break line, select the location of the new break from the drop-down
lists on the left side of the window, and then select Set/Remove.
● To remove a break line, use the drop-down lists to select the location of the
line you want to remove, and then select Set/Remove.
You can also add and remove break lines directly on the assessment graph
by moving the mouse cursor over the assessment graph and clicking once to
add or remove a break line.
b. Select the Text tab to record assessments, recommendations, or follow-ups
for the new boxes.
Composer Database
You can create more than one Composer database. For example, if two doctors use
the same scanner, but they use different assessments, then the doctors should have
separate Composer databases.
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Reporting
Available Reports
1. Select Composer menu > Practice Management Tools.
The Practice Management Tools (Select Report) window appears where you can
add, edit, and delete reports, as well as set BMD Site/Region filters (211) and view
the History Catalog (212).
The conditions defined here are used to produce the patient list when generating
a report.
2. Add (209), edit (211), or delete (211) a report query.
3. Click Next to advance to Available Report Types.
4. Select the Output format:
● Patient List (206)
● HCFA Form (208)
● Mail Merge (208)
● Chart (208)
Patient List Output
The Patient List option generates a list of all patients meeting the query criteria. Click
the Customize button to tailor the patient list output. Select one of three output types:
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Add a Query
1. Select Composer menu > Practice Management Tools.
The Practice Management Tools (Select Report) window appears, where you can
add, edit, and delete reports, as well as set BMD Site/Region filters (211) and view
the History Catalog (212).
The conditions defined here are used to produce the patient list when generating
a report.
2. Select Add.
3. Enter a name for the query and a description for the report criteria.
The conditions defined here are used to produce the patient list when generating
a report.
Use a naming method for the reports that makes them easily identifiable. For
example, if you are creating a report that will include all patients over 50 that
have a T-Score of less than 2.0, the report could be named “Over 50 and T-Score
less than 2.0.”
4. In the Practice Management Tools Add Query window, select Add.
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5. In the Add Condition dialog box, select from the drop down menus for the
condition.
Only the conditions displayed are available (you cannot enter facility-specific
conditions).
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Edit a Query
1. Select Composer menu > Practice Management Tools.
The Practice Management Tools (Select Report) window appears, where you can
add, edit, and delete reports, as well as set BMD Site/Region filters (211) and view
the History Catalog (212).
The conditions defined here are used to produce the patient list when generating
a report.
2. Select Edit from the Practice Management dialog to make modifications to the
name, description, or conditions associated with the report.
3. If desired, change the name of the report or the description associated with the
report.
Use a naming method for the reports that makes them easily identifiable. For
example, if you are creating a report that will include all patients over 50 that
have a T-Score of less than 2.0, the report could be named “Over 50 and T-Score
less than 2.0.”
4. Next, modify conditions associated with the report as desired, including the
criteria for each condition and how each of the conditions are handled. You can
add, edit, and delete conditions.
5. After all modifications are made, select OK.
The main Practice Management Tools dialog appears, highlighting the recently
edited report.
6. Click Next to advance to Available Report Types.
Delete a Query
1. Select Composer menu > Practice Management Tools.
The Practice Management Tools (Select Report) window appears, where you can
add, edit, and delete reports, as well as set BMD Site/Region filters (211) and view
the History Catalog (212).
The conditions defined here are used to produce the patient list when generating
a report.
2. Select the report to be deleted, and click Delete.
3. At the prompt, click OK to permanently delete the business report.
4. Click Next to advance to Available Report Types.
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2. Select Setup > BMD Site/Region filters for T/Z-score Queries to choose the sites
and regions for the T- and Z-score reports.
Expand the sites to display the available regions. Select sites and regions as
needed.
Click the Copy from Physician Reports button to use the Sites and Regions from
Composer.
History Catalog
1. Select Composer menu > Composer/Practice Management Tools.
2. Click the History Catalog button to view the History Chart.
In order to view a History Chart, multiple pie charts (208) must be saved under
one condition or query heading.
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Database Maintenance
8
Database Maintenance
Database maintenance procedures are performed on the Directory screen (select
Directory from the Main screen or from the Common toolbar.
Options to complete database maintenance procedures are given in the Database
sidebar (see Screens and Toolbars (227)).
The Database sidebar includes the following database maintenance tools:
● Edit Database (214)
● New Database (216)
● Rebuild Database (218)
● Compress Database (213)
The database maintenance tools are not displayed by default.
Select the More>> button if you are unable to view the
database maintenance tools.
Compress Database
The Compress Database option lets you remove excess records that are left in the
database when you delete patient records. For performance reasons, these records
are left temporarily in the database.
The Compress Database option also performs a repair function on the database.
Large databases may take a long time to compress. In networked environments, run
the Compress utility from the closest proximity to where the database resides.
1. Select Compress Database from the Database sidebar.
The database maintenance tools are not displayed by
default. Select the More>> button if you are unable to
view the database maintenance tools.
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Delete Database
1. Select the database you want to delete from the Database sidebar.
The database maintenance tools are not displayed by
default. Select the More>> button if you are unable to
view the database maintenance tools.
Edit Database
Select the Edit Database option to perform the following tasks for the active patient
database:
● Change the name of the database.
● Modify which authentication method is used when the application connects to
the database.
● Refresh the current working folder where Exam files are stored.
● Modify the database’s archive or backup settings for the current workstation.
● Update the description of the database.
1. Select Edit Database from the Database sidebar.
The Edit Database window appears.
2. In the Name field, change the name of the active patient database. This name
appears in the list of databases shown in the Database sidebar.
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The User ID for the authentication method you select must also be set up in SQL
Server’s configuration. By default, SQL Server is installed with an account that has
UserID “sa” and password “lunar” This can be modified by installing Microsoft’s
SQL Server Management Studio and setting whatever authentication preferences
you choose.
4. The Folder field displays the name of the folder in which the Exam files are stored.
You cannot modify this location.
5. If you initially set up the active patient database with a working folder on a
non-shared drive and then later decided to share the drive and connect to the
same database from a different enCore workstation, you can refresh the working
folder by clicking the Refresh Working Folder for Mulit-User Database button on
the original workstation. Once the folder is refreshed on the original workstation,
you can return to the new workstation and connect to the database.
6. Click Archive / Backup Settings to open the Archive / Backup Database Settings
window and edit the following options:
Option Description
Allow Archive from this Change the archive permission for this workstation.
workstation A check in this box means archive is allowed on this
workstation. This setting is important if your files are
stored in a database that is used by several workstations.
Only one workstation should be used to archive all of the
files in the database. Do not allow files to be archived
from more than one workstation.
Allow Backup from this Change the backup permission for this workstation.
workstation A check in this box means backup is allowed on this
workstation. Every workstation should have its own
backup.
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Export Database
The Export Database option lets you export results for all patients and exams in
the database to tab-delimited text files, which can be imported into a spreadsheet
program such as Microsoft Excel.
1. Select the database you want to export from the Database sidebar.
2. Select Directory menu > Database Utilities > Export.
3. Follow the steps on screen to customize the output.
4. In the Text File field, enter a path and filename.
This filename will be used as a prefix for the output files to be generated.
5. Click OK.
Results of all the patients and exams in the database are exported to tab-delimited
text files, saved at the path you specified.
New Database
1. Select New Database from the Database sidebar.
The New Database window appears.
2. In the Name field, enter the name of the new patient database to be used to
store patient records. This name appears in the list of databases shown in the
Database sidebar.
3. Specify information about the associated SQL server and SQL database:
a. In the Server Name field, update the name of the SQL server that hosts the
database. Or, if the current workstation hosts the database, select Local PC.
If databases are hosted on a shared drive, an
additional level of security can be provided by
installing Microsoft SQL Server Management Studio
and using that software to configure the server to
accept encrypted connections.
b. In the Database Name field, enter the name of the SQL database. Or, to use
the same name as specified in the Name field, select Use Same Name.
4. Configure the authentication method.
Select enCORE Default Authentication to use enCORE as originally installed and
without using security settings configured in SQL Server.
If you would like greater security on your database, first configure security settings
for the database in SQL Server and then specify in the New Database window the
authentication method that corresponds to those settings. To configure your SQL
Server database security settings, install the Microsoft SQL Server Management
Studio and use it to grant rights to specific Windows login accounts (Windows
Authentication) or to specific User ID and Password combinations (SQL Server
Authentication).
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5. Click Archive / Backup Settings to open the Archive / Backup Database Settings
window and configure the following options:
Option Description
Allow Archive from this Change the archive permission for this workstation.
workstation A check in this box means archive is allowed on this
workstation. This setting is important if your files are
stored in a database that is used by several workstations.
Only one workstation should be used to archive all of the
files in the database. Do not allow files to be archived
from more than one workstation.
Allow Backup from this Change the backup permission for this workstation.
workstation A check in this box means backup is allowed on this
workstation. Every workstation should have its own
backup.
Perform Exclusive When you install a new enCORE software upgrade,
Lock and Backup you may need to upgrade your database the first time
when upgrading you connect to it. By default, this database upgrade
(recommended) process will lock the database and create a backup of the
database before proceeding with the upgrade. Clearing
this check box means that when an upgrade occurs,
enCORE will not do either of these steps. Clearing this
check box is not recommended unless your site has
special rules about client software performing backups.
Backup Folder Change the location of the folder that is used to back up
the software configuration and database files during an
upgrade. The specified folder must be on a drive local to
the server.
Use Database Folder Change whether the application stores the backup files in
(recommended) the same folder as the database files.
6. In the Description field, enter a brief description of the database. This description
appears in the Database sidebar for the active database.
7. Select OK. At the prompt, specify the working folder for the database. This is the
location of the exam files referenced by the database.
If working folders are maintained on a shared drive, an
additional level of security can be provided by setting
Windows permissions on those folders.
Archive
1. Select Archive to copy image files from your computer hard drive to an archive
location.
2. Select the archive method:
● Archive all exams for all patients
● Archive all exams for all patients in the current search results
● Archive all exams for selected patient
● Archive selected exam
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Restore Backup
Restoring from backup also restores enCORE software settings and Composer style
sheets.
1. Select Directory > Database Utilities > Restore Backup.
2. Browse to the backup.zip file location.
3. Click OK.
If the file is kept on remote media, the software prompts for the appropriate
archive disk.
Rebuild Database
Import first, then rebuild.
The Rebuild Database option lets you rebuild (recreate) a database that has been
lost due to a computer hardware malfunction. You can also use this option to add
external files to the database.
You can rebuild the database from files that you have copied into the working
directory, or from files stored on an archive disk.
1. Select Rebuild Database from the Database sidebar.
The database maintenance tools are not displayed by
default. Select the More>> button if you are unable to
view the database maintenance tools.
2. To rebuild the database from an archive disk, select Archive as the Source
Directory Option. Otherwise, leave the Source Directory set to Working.
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3. In the Filter By dialog box, select how you want the image files to be filtered.
4. Select the files you want to use to rebuild the database, or click Select All to use
all of the files.
Use the Ctrl key to select multiple images.
5. Select OK to rebuild the database.
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Dual Femur NA X NA
Forearm NA X NA
Total Body X X NA
Lateral/LVA Spine BMD NA X NA
Orthopedic Hip NA X NA
Hand NA X NA
Orthopedic Knee NA X NA
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Image Support
The corresponding image files may be added to the database for viewing:
● DPX-IQ - AP Spine, DualFemur, Femur, Forearm, Total Body, and Orthopedic Hip
● EXPERT - AP Spine, DualFemur, Femur, Forearm, Total Body, Orthopedic Hip, and
Hand
When an image has been added, the directory provides the original file name.
Task Scheduler
When you select Tools > Task Scheduler, the Task Scheduler window appears. Use
these tools to add, edit, or delete a task.
Icon Tool Description
Add Click Add to add a new task.
A Task window appears after you click Add or Edit. Complete the fields as described
below, and then click OK.
Field Description
Task Type the task name in the Task field, or click Choose from List
to select from a list of common task names.
Time Use the Time field to set the time for the task to be performed.
Every Use the Every field to set the task frequency. Choose Day(s),
Week(s), or Month(s).
When it's time for Click the When it's time for this task drop down menu to
this task choose the task action. Choose Prompt Me, Perform Archive
All, or Perform Backup.
Check Ask me before proceeding to receive a message
containing the Reminder Text before the task begins. Edit the
Reminder Text as desired.
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● The installed edition of Microsoft SQL Server must be 2008, 2012, 2014, or
Microsoft SQL Server Express 2008 R2. Some enCORE features are not compatible
with earlier releases.
● Unless the site is using Microsoft SQL Server Express 2008 R2, the site should
be familiar with how to install and configure SQL Server. GE Healthcare does not
support installation and configuration of the full version of SQL Server.
● The site also needs an account set up on SQL Server that has the authority to
create and modify databases (typically an administrator account), because enCORE
requires such operations for things like New Database, Backup/Restore, and so on.
Typical day-to-day operations can be done with an account that has much more
limited authority.
Network Speed
Expected network speeds for a database of 10,000 patients is approximately:
Network Requirements
● Cat5-enhanced rated cables to handle Base100
● No external programs write/update the shared database
● No external programs read enCORE database while the enCORE program is
running on any system
● All systems sharing the database must be upgraded simultaneously.
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Troubleshooting
9
Troubleshooting
Point Typing Is Wrong
For example, bone edge lines do not follow bone.
Possible causes and remedies:
● If the point typing is wrong on less than 25% of the total image, see Advanced:
Adjust Point Typing (79). If more than 25% of the point typing is incorrect, the
quality of the results may be compromised.
● Patient has had a radiographic contrast study recently. Wait 72 hours after
contrast study before scanning.
● Wrong scan mode. Compare the Mode and Average Tissue Thickness from the
Analysis screen > Information tab with the Patient Thickness and Weight Limits
values for enCORE Measurement Modes (68).
No Trending
Possible causes and remedies:
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● Trending (244) is not enabled. Check the Trending box under File > Print.
● Region not available on previous scan. Select a region available on the previous
scan.
For example:
■ DualFemur trending Total Mean, but previous exam only has one femur
■ AP Spine trending L1-L4, but previous exam has a vertebra excluded
QA Fails
Possible causes and remedies:
Perform another QA. If it fails again, contact GE Support or your GE distributor.
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Screens and Toolbars
10
Screens and Toolbars
This section describes the screens and toolbars that are shown throughout the
program. Screens and toolbars provide the options to complete the procedures given
in this manual.
Using Screens
The screens provide information that lets you set up and complete measurements,
analysis, and quality assurance procedures. At the bottom of each screen, short
descriptions of procedures and alternative keystrokes are given to help you complete
a procedure.
Using Toolbars
The toolbars show icons representing tools, each of which let you complete a specific
procedure. To view a short description of a tool, hover the mouse pointer on the icon.
Patient Block
The Patient block is shown at the bottom of the Analyze, Directory, and New
Measurement screens. The Patient block gives information about the patient that is
being analyzed, measured, or is currently selected at the Directory screen. This is the
same information you record in the Patient Information dialog box or select from the
Patient list before starting a new measurement.
Help Text
Help text is located in the lower left corner of every screen in enCORE software.
The help text provides keystroke functionality, current operation of the system, and
instructions for the software user.
Main Screen
The main screen is the first screen shown when starting the enCORE software.
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Common Toolbar
The Common toolbar is shown on all screens.
Icon Tool Description
Measure (F2 or Ctrl+M) Click Measure, then enter patient
information or select a patient from the
database to start a new measurement.
Analyze (F3 or Ctrl+A) Click Analyze, then choose an image file
for analysis.
Directory (F4 or Ctrl+D) Select Directory to work with patient files
and complete database maintenance
procedures.
QA (F5 or Ctrl+Q) Select QA to start a Quality Assurance test.
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If the scan arm has been set to Home at the foot end of
the table, and the foam leg block is used for AP Spine
measurement, a warning will appear. Please remove patient
positioner.
Park Scanner
Select Park Scanner (Ctrl+K) from the Measure menu to move the scan arm to the foot
of the table (DPX-NT Mobile) or to the head of the table (Prodigy Mobile) for lockdown.
Analyze Screen
The Analyze screen is used to analyze image files. This screen is shown when you
select Analyze from the Common toolbar or the main screen, or when you select an
image file for analysis from the Directory screen.
In addition, this screen is shown immediately after a patient measurement if the
Analyze When Done option is selected on the New Measurement screen.
Analyze Toolbar
Select tools from the Analyze toolbar to complete analysis procedures (77). Refer to
specific scan types for detailed analysis recommendations for each measurement site.
General Analysis Tools
Icon Tool Description
Imaging (Ctrl+I) Adjust contrast and zoom the image file.
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ROI Tools
Icon Tool Description
Delete ROI Delete an ROI.
Results Tabs
The Results tabs on the Analyze screen let you review BMD, reference, trend, and
composition results. To change default settings for graphs, reference data, and results
tables, refer to Options (243).
The following Results tabs are available:
● ScanCheck tab: Provides a checklist of potential measurement and/or analysis
errors.
● Densitometry tab: Provides BMD, BMC, Area, and reference results.
● Trend tab: Provides results trending over time.
● Information tab: Gives information related to the scan parameters.
● Composition tab: Provides Total Body composition or Spine/Femur estimated
composition results.
● AFF tab (Atypical Femur Fracture): Provides measurements of the lateral cortex
along the femoral shaft such as cortical width and beaking index, which can be
trended across serial scans.
● AHA tab (Femur Advanced Hip Assessment): Provides information about hip axis
length, hip strength, and hip geometry results.
● Morphometry tab: Provides vertebral heights and ratios.
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Directory Screen
The Directory screen is shown when you select Directory from the Main screen or
from the Common toolbar. This screen lists the patient files and exams that are stored
in the active database.
The Directory screen is divided into four areas:
1. Search option
2. Patient list
3. Exam list
4. Database sidebar
Search
Use the Search option to quickly locate a patient record and exam file in a large
database. The Search option is located near the top of the Directory screen.
1. Select the database field to use in the search.
2. Enter the patient information to use in the search.
3. Select Search.
The patient record and associated exam files are shown in the Patient and Exam
lists.
Use the All Patients button to clear the search criteria and list all patients in the
database.
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Directory Toolbar
Icon Tool Description
Edit (Ctrl+E) Edit Primary, Secondary, and Additional patient
data. Opens the patient record if a patient
is currently highlighted in the Patient List, or
opens an exam record if an exam is currently
highlighted in the Exam list.
Editing the patient record does not save the
updated information to exams that have
already been acquired for that patient.
New (Ctrl+N) Enter a new patient that is not in the patient
database.
Patient List
Use the Patient list to select a patient to measure. Double-click a highlighted patient
record to start a new measurement.
The Patient list shows patient records in the database according to the patient’s last
name, first name, ID, and birth date. The patient information for the selected patient is
also shown in the Patient block at the bottom of the Directory, New Measurement,
and Analyze screens.
Exam List
Use the Exam list to select an exam to analyze. Double-click a highlighted exam to
analyze the exam. The Exam list shows the patient measurements in the database
according to measurement type, date measured, date analyzed, file name, and
archive label. The Exam list may include exams made up of multiple images.
Assign a status or notes to an exam by right-clicking the exam in the directory and
selecting Change Status or Notes. Choose from a list of five status types:
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Icon Status
No icon Not Reviewed
Pending Review
Rejected
Approved
Closed
Enable Exam Status/notes features and set defaults, actions when sending a report,
and status colors under Tools > User Options > Directory tab > Directory Status
button.
Database Sidebar
The Database sidebar shows the database that is currently being used (active
database) and the working path of that directory. If you do not see this information,
select More >>.
The Active Database panel indicates the location of the database and the drive used
for archiving patient studies. Most systems use a hard drive location for the working
path and a removable media drive for the archive drive. This information is always
available on the Directory screen.
All databases are listed on the database sidebar. Creating more than one database
is especially useful for customers performing research studies. The currently active
database is highlighted in the available databases list. To change databases, highlight
the desired database in the list.
The lower portion of the Database sidebar shows all available databases, and
database maintenance options.
Database maintenance tools provide the ability to edit, create, rebuild or compress the
database. Refer to Edit Database (214), Compress Database (213), Rebuild Database
(218), or New Database (216).
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System Status
The Quality Assurance screen indicates the current operating status of the system.
To ensure accurate results, the System Status should indicate System is ready to
measure patients before performing patient measurements.
System status
Options
Select Tools from the Main menu to access User Options (236), Connectivity Options
(250), or the Error Log (252). These options are also available from the Options button
on the Main screen.
User Options
User Options let you set and change the program’s default settings.
1. Select Options (F6) from the Main screen and select User Options.
OR
Select Tools menu > User Options.
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3. Select OK to save changes. If you do not want to save changes, select Cancel.
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Systems Tab
The scanner's System ID is unique. The System ID is needed for support.
Feature codes are only compatible with a specific system ID, and enable purchased
options in the software. To try a feature before buying it, contact your sales person
for a trial feature code.
Icon Item Description
Additional Feature Enter Trial and IRB feature codes.
Codes Expiration dates are displayed below each
feature code.
User Interface ● Automatic Return to Directory returns the
Options display to the Directory screen (rather than the
main screen) after a measurement, analysis,
or QA is completed
● HIPAA Secure View hides patient information
on the Directory screen.
● Play Multimedia Sounds enables sound for
multimedia content.
● Auxiliary Workstation is for use with MUDB
(Multi-User Database) setups. Select this
option to prevent the workstation from
performing QA procedures or patient
measurements. The Auxiliary Workstation
option is shown if you purchased the MUDB
feature. The Number of Open Exams option
lets you choose how many exams can be
opened for analysis at the same time.
Exam File Options ● HIPAA Secure Filename removes patient
name information from the scan file name.
● HIPAA Secure Filename Off:
SmithJf0m485s.dff
● Compress Exam Files compresses exams to
conserve space for high resolution images
such as iDXA scans.
● Encrypt Exam Files encrypts files so the file
information cannot be viewed with other
applications.
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Directory Tab
Icon Item Description
Patient Sort Sort by First name, Last name or Patient ID.
Options Sort Ascending or Descending.
Exam Sort Options Sort by Measurement, Date Measured, Date
Analyzed, File Name, Archive, Import, or Status.
Sort Ascending or Descending.
Patient List Choose Patient Third column contents: Patient ID,
Columns Facility ID, Department ID or Exam ID.
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Analyze Tab
Femur Analysis AHA: Hip Axis Length, Upper Neck region, Lower
Options Neck region.
Calculate Hip Strength results and Hip Geometry
results.
AFF:
Enable display of AFF results for proximal only
femur images.
Change the threshold used to display an arrow
where the maximum beaking index is located on
AFF tab of femur images.
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Trending Tab
Icon Item Description
Trend Graph Select Line Pattern, Densitometry Trend Graph
Options (Percent Change or Reference), Morphometry
Trend Graph (Percent Change or Absolute Value),
or Composition Trend Graph settings.
Trend Table Flag Significant Change On or Off. Configure
Options how trending is to be displayed.
Item Description
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Item Description
BMDCS/Lunar), USA (Combined NHANES/BMDCS/Lunar),
USA (Combined NHANES/Lunar), USA (Lunar), and USA
(NHANES 1999–2004).
Use Same Reference Enable to select the displayed reference population for
Population for All Sites all sites.
Disable to select different reference populations for each
site.
When this option is enabled, if a Reference Population
has been assigned to a site that it does not support, then
(Not Supported) appears for that site. When this option
is not enabled, the Available Reference Populations list
shows only the Reference Populations that support the
currently selected site.
Default Region Choose the region to be the default region for analysis
for each scan type.
Set All Click Set All to enable all of the reference settings.
Item Description
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Image Tab
Icon Item Description
N/A Image Options Turn on or off: Interpolate, Invert Image, Show bone
edges, Show Artifacts, Size Image to Fit Screen
on Open, Display two Total Body images, Display
DualFemur Images top/bottom, Display Composition
Image for Total Body.
Image Colors Change image colors for ROIs, Zoom Region/Masks,
Bone Edges, Point Typing, Markers, Artifacts, Bone
Color Mapping, Tissue Color Mapping (iDXA only).
Air Color Screen:
● Standard: Makes air/unscanned pixels black if
Inverse is set to Off, or white if Inverse is set to On.
● Transparent: Makes air/unscanned pixels the
same color as the Windows background.
● Color: Makes air/unscanned pixels a user-selected
color. Click in the color rectangle, and choose the
desired color from the color selection dialog.
Air Color Print:
● Standard: Makes air/unscanned pixels black if
Inverse is set to Off, or white if Inverse is set to On.
(Printing has Inverse set to On by default.)
● Transparent: Makes air/unscanned pixels white
on the printout.
● Color: Makes air/unscanned pixels a user-selected
color. Click in the color rectangle, and choose the
desired color from the color selection dialog.
Color Coding Spectrum defines the colors displayed
on Total Body images when the Color Coding option
is selected.
Total Body color options:
● Default Tissue Colors defines which of the three
color options is displayed when initially opening
a new Total Body image: Black and White, Color
Coding, or Color Mapping (iDXA only).
● Color Coding Defaults are the %Fat values where
the Image contrast bars will be placed. These
settings map to the Color Coding Spectrum,
effectively identifying which colors apply to which
%Fat values. These are only the defaults, and
may be modified on the Image Tools dialog for
each image.
Image Export JPG Quality from 10 to 100, where 10 is the lowest
Options quality and 100 is the highest.
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ScanCheck Tab
At the top of the screen, select whether to enable ScanCheck, and whether to default
to ScanCheck tab (show ScanCheck tab first when analyzing).
At the bottom of the screen, select whether to include ScanCheck indications on
reports.
In the sections labeled AP Spine, Femur, etc., use the checkboxes to select which
ScanCheck items to show on the analysis screen.
AP Spine
AP Spine Detect the following problems:
AP Spine–Measure Correct scan mode used?
AP Spine alignment reasonably straight?
AP Spine–Analyze Optimal contrast and brightness set?
ROIs properly defined?
L1-L4 labeled correctly?
Tissue region properly defined?
Bone edges properly defined?
Results consistent with previous scan?
AP Spine–Anatomy Analysis region free of unusual high density bone?
Free of unusual T-score variation?
Free of unusual curvature?
AP Spine–Comments Comments
Femur
Femur Detect the following problems
Femur–Measure Correct scan mode used?
Sufficient pelvis and shaft separation?
Femur shaft reasonably straight?
Proper femur rotation?
Femur–Analyze Optimal contrast and brightness set?
ROIs properly defined?
Tissue region properly defined?
Bone edges properly defined?
Results consistent with previous scan?
Femur–Anatomy Analysis region free of unusual high density bone?
Femur–Comments Comments
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Total Body
Total Body Detect the following problems
Total Body–Measure Correct scan mode used?
Patient within scan field?
Total Body–Analyze Optimal contrast and brightness set?
ROIs properly defined?
Patient Height Entered Correctly?
Patient Weight Entered Correctly?
Total Body–Anatomy Analysis region free of unusual high density bone?
Total Body–Comments Comments
Forearm
Forearm Detect the following problems
Forearm–Measure Forearm alignment reasonably straight?
Forearm–Analyze Optimal contrast and brightness set?
ROIs properly defined?
Tissue region properly defined?
Bone edges properly defined?
Forearm–Anatomy Analysis region free of unusual high density bone?
Forearm–Comments Comments
Reports Tab
Icon Item Description
Report Trend Multiple Results Only, Invert Image, Show
Configuration Comments, Show Ethnicity.
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QA Tab
Icon Item Description
N/A Default QA Copies Number of QA Report copies.
N/A Automatic Daily QA Automatically print QA report after QA
Print procedure is completed.
N/A Automatic return to Automatically return to QA trend screen
trend screen after QA procedure is completed.
N/A Graphical Interface Display QA test graphics.
N/A Enable QA stability Enable relative mean and rolling
analysis standard deviation checks of QA test
values.
Measure Tab
Icon Item Description
N/A Save Prompt at end of scan Display a message after every measurement
that asks whether to save the measurement.
N/A Allow continue after Allows resuming aborted measurement.
SmartScan abort
N/A Show Previous Scan Show previous patient scan during new
measurement.
N/A Allow Scanner Start Button Allows starting a scan using the Start button
to initiate a Measurement on the scan arm (iDXA only).
N/A Use Old Positioner for Select appropriate Lateral positioner for the
Lateral Measurements site.
(Densitometry and
Morphometry only)
N/A LVA Reverse (for LVA, scan Measure patients lying on right side rather
patient facing foot of table) than left side.
N/A Default to Femur Detail (Prodigy and DPX only) Enable to use Detail
mode mode for femur measurements.
Disable to use Standard mode for femur
measurements.
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N/A OneScan (don't use Foam Perform AP spine and DualFemur exam
Leg Block positioner for AP without repositioning between scans.
Spine scans)
Connectivity Options
Connectivity options let you change report delivery, fax, email, DICOM, and HL7 default
settings.
To view the connectivity options:
1. On the Main screen, press F6 and select Connectivity Options.
OR
Select Tools menu > Connectivity Options.
2. Select one of the Connectivity Options tabs:
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Error Log
If you encounter difficulties that prevent normal operation of the program, view the
Error Log for a list of errors that may be causing the problem.
To view the Error log, select Options (F6) from the Main screen and then select Error
Log, or select Tools menu > Error Log.
To export the Error Log, select Tools > Send Configuration and select Error Log.
The error log consists of two sections:
● Sessions: Lists the dates and times that the program was being used and the
number of errors that occurred during each session.
● Errors: Gives a description of each error that occurred during the selected session.
Click Troubleshoot to see a help topic about the selected error. Click Find Errors
to see similar errors in the list.
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Reporting Errors to GE
If you cannot correct the error condition, go to Tools > Send Configuration and check
the Error log and Configuration files options. Email the files to GE Support or your
GE Distributor.
You can also print the error log by selecting Print Errors. Call your GE representative
and provide them with the error description as shown in the Errors section.
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Security
11
Introduction
This section describes the security features, functionality and administrative
requirements of GE Healthcare enCORE software. It is provided to assist you in using
the system in a manner that protects patient privacy and security in your setting, and
to work in accordance with local and federal regulatory requirements.
This section also addresses expectations for the environment where the enCORE
software will be used, and contains information regarding security upgrade
procedures.
The healthcare provider is encouraged to use risk management procedures to assess
and prioritize security and privacy risks. Based on a risk assessment, the capabilities
of enCORE software can best be applied. The risk assessment should carefully balance
regulatory compliance, patient safety, as well as security. In cases where security
mitigation conflicts with patient safety, patient safety should be considered a higher
priority.
Security Features
The enCORE software incorporates a broad assortment of security features designed
to allow a complete and flexible approach to safe and secure implementation,
focusing on the principles of confidentiality, integrity, and availability. Information on
the capability and use of these features are detailed throughout this document.
Access Controls
Access control is the overall mechanism used to determine and enforce:
● Who has access
● How individuals gain access
● When access is permitted
● What information may be accessed
Access controls can have both physical and electronic aspects, and include
authentication and authorization process.
With Windows, you can set up security policies to control access to your enCORE
software workstation and patient files. A Windows user account defines the actions a
user can perform in Windows, such as:
● Who accesses your computer
● What resources users are authorized to use on your computer
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You can also set up Windows auditing so that a user’s or a group’s actions are
recorded in the Windows event log. Please see the Audit Controls (259) section for
more information on how to enable local security auditing.
Once configured, when a user logs in to the Windows operating system and starts the
enCORE software, the functionality within the enCORE software is limited based on
the user’s assigned role
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5. With a group selected in the Configure Limited Functionality window, click Edit
Group Settings. This opens the Change Security Settings window for the selected
group.
6. Select the application functionality to which the selected group will have access.
For example, for the enCOREPhysicians group, choose Create Composer Reports.
Select one or more of the following options:
● Modify Configuration. Allows system configuration changes.
● Modify Style Sheets. Allows style sheet editing.
● Measure. Allows patient measurement.
● Analyze. Allows exam analysis adjustments.
● Create Composer Reports. Allows creation of Composer reports.
● Digitally Sign Reports. Automatically applies the user’s name to reports.
This option requires the user’s name to be specified in the Full name property
of his or her Windows User account.
7. Click OK and return to the Security Options window.
8. Click OK to close the Security Options window and finish.
Authentication
Authentication is the process of proving individual identity and is a key element in an
access control system.
User accounts with passwords can be set up to restrict access to patient health
information to only authorized users. The Windows operating system supports
advanced password controls. Passwords can be controlled based on age, pattern,
length, history, and dictionary.
A greater level of system security can be obtained by modifying the accounts and
passwords from their factory settings.
Password Management
Password use has some risks, as passwords may be forgotten, lost, guessed, or
“cracked” with various methods such as dictionary and brute-force attacks. To make
passwords safer, several rules can be applied to password creation.
Password Common Settings Comments
Attribute
Minimum 4 – 16 characters Shorter passwords are easy to remember, but
Length also easier to compromise. Longer passwords
are more secure, but more likely to be
forgotten or written down. Longer passwords
are more resistant to brute force attacks
Expiration 30 – 360 days, or Off Expiration dates force users to change
passwords on a regular basis. A rule of
thumb is to balance expiration with length,
so that passwords expire before they could
be cracked.
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Authorization
Authorization is the process of granting and revoking an individual’s rights to access
information, functionality, or services, and is another key element in an access
control system. Although primarily an administrative process that is driven by an
organization’s policies and procedures, enCORE software contains features that help
implement and enforce an organization’s method.
enCORE software can be run with a restricted user account. Restricted users are
unable to install programs or change operating system settings.
Audit Controls
The ability to record and examine system activity is crucial to a successful information
security program, as well as compliance with regulatory requirements in many
environments. This section covers security audit logs only. Clinical, diagnostic, and
service logs are covered elsewhere.
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Audit system events Determines whether to audit when a user restarts or shuts
down the computer or when an event occurs that affects
either the system security or the security log.
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Customer Responsibilities
Customers are responsible for staying informed about vulnerability information and its
impact on GE Healthcare systems by visiting the GEHC Product Security website. Refer
to Using the GEHC Product Security Database (268). Customers are also responsible
for the installation of validated Microsoft security software patches.
1. Owners of enCORE-based systems are to apply the validated Microsoft security
patches appropriate for their version of the Windows operating system:
2. The patches are available for download from Microsoft’s website at
http://www.microsoft.com/technet/security/default.mspx
3. Select the Security Bulletins tab.
4. On the next page, select the link for the appropriate bulletin.
5. On the next page, choose the download link for the operating system that the
product uses.
6. On the next page, select the appropriate language option, and then click the
Download button.
7. When prompted for file download, save the patch file to your computer’s Desktop.
8. After the file download has completed, and run the patch to install it.
Product Features
Product features that contribute to malware defense include:
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unnecessary operating system services and protocols are turned off by default.
This helps to restrict unauthorized access.
● Security updates and patching processes: At the time of product release, any
critical operating system security patches are installed on the system. Additionally,
any new security patches are automatically loaded with every software update.
GE Healthcare releases security patch validation information through the GEHC
Product Security Website http://prodsecdb.gehealthcare.com and Technical
Support in a timely manner.
Anti-virus programs should be installed and active on the enCORE computer operating
the bone densitometer. However, virus scanners have significant drawbacks including
the following:
● Do not initiate an anti-virus scan when operating the bone densitometer. Certain
files may be marked read-only.
● Anti-virus software may act inappropriately on false positives. Double check
quarantine status before taking any permanent action. Medical image files can
be damaged because the virus scanner attempts to fix what it falsely identified
as a virus.
● enCORE software may not operate properly if the virus scanner consumes too
much memory or system resources.
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Workstation Security
You can set up a screen saver with password protection to lock access to the system
after a select period of inactivity.
To protect against over-the-shoulder access while the system is unattended, it is
recommended that secure session locks be established on the system.
You can also set up user accounts to lock out the account after a predetermined
number of successive failed login attempts.
Data Protection
Data protection and privacy is often driven by administrative policies and procedures
of the customer. enCORE software contains functionality that may help implement
data protection initiatives.
Device-to-device authentication by AE Title and IP address is supported for DICOM
and HL7 services.
128-bit data encryption is supported over the Internet.
When GE personnel require exam files for the purpose of servicing a system, the
files are obtained using the HIPAA Secure Copy process described below. In addition,
GE follows a well-defined Data Retention Policy with respect to these exam files,
and when systems are retired due to replacement. Contact GE to obtain a copy of
this Data Retention Policy.
HIPAA Secure settings of enCORE
HIPAA Secure Filename, when enabled, ensures generation filenames of patient
exams without patient information. Encrypt Exam Files, when enabled, saves the
patient exam data in encrypted format.
1. Select Tools menu > User Options.
2. On the Systems tab, select Exam File Options.
3. HIPAA Secure Filename and Encrypt Exam Files settings are shown. They are
both enabled by default.
4. Click Cancel to exit.
HIPAA Secure View, when enabled, hides all patient information on all screens.
1. Select Tools menu > User Options.
2. On the Systems tab, select User Interface Options.
3. HIPAA Secure View settings are shown. It is disabled by default.
4. Click Cancel to exit.
HIPAA Secure Copy, when enabled, allows bulk patient de-identification. All patient
identifying information (including name, ID, address, telephone number, and insurance
information) can be removed before exchanging patient databases or scan files.
When data is transferred to external media without using HIPAA Secure Copy, after the
media is no longer needed it should be disposed of securely and safely. Disposal of
sensitive items should be logged where necessary in order to maintain an audit trail.
1. Select Directory menu > Send Exam to (disk or email).
2. HIPAA Secure Copy (purge patient data) settings are shown. It is enabled by
default.
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Security Operations
This section focuses on security operations, and contains information to guide in the
preparation of a secure environment for enCORE software.
Security operations are best implemented as part of an overall “defense in depth”
information assurance strategy used throughout an Information Technology system
that addresses personnel, physical security and technology. The layered approach
of defense in depth limits the risk that the failure of a single security safeguard will
allow compromise of the system.
Network Security
GE strongly recommends that medical devices be operated in a secure network
environment that is separate from an organization’s general purpose computing
network. There are many effective techniques for isolating medical devices on a
secure sub-network, including implementing firewall protection, demilitarized zones
(DMZs), Virtual Local Area Networks (VLANs), and network enclaves.
GE recommends verifying the following system configuration:
1. Disable TCP test services
2. Disable file and print sharing
3. Disable NetBIOS over TCP/IP (when available)
Business Continuity
Patient data archive and backup is supported to protect against hardware failures
and other disasters. Refer to Archive (217) and Restore Backup (218).
GE recommends the use of uninterruptible power supplies to reduce the risk of data
loss due to unexpected power outages to the enCORE system.
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Remote Service
Often the most efficient and cost effective manner for GE to provide service is to
remotely connect to the enCORE system. Every effort is made to ensure that this
connection is as secure as possible.
The enCORE software supports InSite remote connectivity. There is no remote
activation of the scanner at any time.
No connection to a customer’s system is possible unless the customer is at their
system and enables the InSite session to occur.
Security programs provided by the customer’s Internet service provider (ISP) or local
IT person may be used as long as a security scan is not activated when the enCORE
program is running. Close the enCORE software before running a security utility.
The enabling of remote access services poses unique security risks. Remote access
services, such as Microsoft Windows Remote Desktop, are not required for and are
not enabled by enCORE software operation. Remote access services are disabled
by default. Note that, although remote access is available through the use of the
InSite ExC Service Tool, these operations are performed outside of Microsoft Windows
Remote Desktop, through a secure connection. See the InSite ExC Service Tool
documentation for details.
InSite 2 Components
● Service Agent: The customer’s InSite 2 program interface is referred to as the
Service Agent. The customer’s computer acts as a local server and controls the
connection functions. The Service Agent’s role is to establish secure communication
to the GE Enterprise Server via an https connection on the Internet.
● Lunar System Service Tool: The Lunar System Service Tool, or Virtual Assistant,
controls the service connection.
● RCOC directory: The RCOC enables the remote desktop tunnel to share the
customer’s computer screen.
● File Transfer folders: These folders are located on the root drive of the customer’s
computer.
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Required Characteristics
The network must meet the specific requirements above for all traffic flows associated
with the subset of features, use cases and workflows required by the responsible
organization’s users.
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Refer to the PSD Getting Started or Help option for instructions in:
● Setting up your profile
● Retrieving the Product Vulnerability Table
● Retrieving a current Manufacturer Disclosure statement for Medical Device Security
(MDS2)
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Specifications
A
Systems Specifications
Lunar iDXA Series
Focal spot to detector distance (cm) 71.5
Focal spot to pad surface distance (cm) 24.5
Focal spot to AP Spine plane distance (cm) 34.0
Focal spot to table top distance (cm) 22
Focal spot to source collimator distance (cm) 19
Prodigy Series
Focal spot to detector distance (cm) 67
Focal spot to pad surface distance (cm) 24.8
Focal spot to AP Spine plane distance (cm) 34.3
Focal spot to table top distance (cm) 22.3
Focal spot to source collimator distance (cm) 19
DPX NT/Pro/MD+
Focal spot to detector distance (cm) 58
Focal spot to pad surface distance (cm) 15
Focal spot to AP Spine plane distance (cm) 24.4
Focal spot to table top distance (cm) 12.4
Focal spot to source collimator distance (cm) 7.25
DPX Duo/Bravo
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Specifications
Physical Specifications
Lunar iDXA Series
Component Version Specifications
iDXA Scanner Full Size Table Dimensions: 287 cm x 131 cm x 125 cm (L x
table W x H)
Weight: approximately 360 kg
Maximum patient weight supported: 204
kg (450 lb)
Prodigy Series
Component Version Specifications
Prodigy Advance, Full Size Table Dimensions: 262.3 cm x 109.3 cm x 128.3 cm
Prodigy Primo, (L x W x H)
Prodigy Forma Weight: approximately 272.16 kg
Scanner table*
Maximum patient weight supported: 159 kg
(350 lb)
Compact Table Dimensions: 201 cm x 109.3 cm x 128.3 cm (L
x W x H)
Weight: approximately 254 kg
Maximum patient weight supported: 159 kg
(350 lb)
Prodigy Primo, Full Size Table Dimensions: 262.3 cm x 109.3 cm x 128.3 cm
Prodigy, Prodigy (L x W x H)
Pro Scanner table* Weight: approximately 272.16 kg
Maximum patient weight supported: 159 kg
(350 lb)
Compact Table Dimensions: 201 cm x 109.3 cm x 128.3 cm (L
x W x H)
Weight: approximately 254 kg
Maximum patient weight supported: 159 kg
(350 lb)
*Depth is measured from the front edge of the scanner table to the back edge of the
scanner arm. Height is measured from the top of the scanner arm to the bottom of
the scanner arm.
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Specifications
DPX-NT/Pro/MD+
Component Version Specifications
DPX NT/Pro/MD+ Full Size Table Dimensions: 242 cm x 103 cm x 128 cm (L x W
Scanner table* x H)
Weight: approximately 272 kg
Maximum patient weight supported: 136 kg
(300 lb)
Compact Table Dimensions: 181 cm x 103 cm x 128 cm (L x W
x H)
Weight: approximately 254 kg
Maximum patient weight supported: 136 kg
(300 lb)
*Depth is measured from the front edge of the scanner table to the back edge of the
scanner arm. Height is measured from the top of the scanner arm to the bottom of
the scanner arm.
DPX-Duo
Component Version Specifications
DPX Duo Dimensions: 186 cm x 86 cm x 147 cm (L x
W x H)
Weight: approximately 275 kg
Maximum patient weight supported: 159 kg
(350 lb):
DPX-Bravo
Component Version Specifications
DPX Bravo Dimensions: 186 cm x 86 cm x 130 cm (L x
W x H)
Weight: approximately 202 kg
Maximum patient weight supported: 159 kg
(350 lb)
Console table 78.5 cm x 63.3 cm x 48.1 cm
(optional)
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Humidity
Make sure the humidity for the scanner area is 20%-80%, non-condensing.
Power Consumption
For all scanner types, a dedicated 20A 100-127 VAC ±10% or 10A 200-240 VAC
±10% circuit (single duplex outlet) with isolated ground (THD<5%) is recommended.
The outlet should be located behind the host PC. See Declarations of Immunity and
Emissions table (321) for power quality guidance.
● The iDXA scanner draws approximately 40 watts when idle and approximately 525
watts during a patient scan (100kV / 2.5mA).
● The Prodigy and Prodigy Advance scanners draw approximately 40 watts when
idle and approximately 450 watts during a patient scan (76kV / 3mA).
● The Lunar DPX NT/Pro/MD+ scanners draw approximately 25 watts when idle and
approximately 250 watts during a patient scan (76 kV / 1.5mA).
● The Lunar DPX Duo and DPX Bravo scanners draw approximately 25 watts when
idle and approximately 250 watts during a patient scan (76kV / 1.5mA).
● The host PC (typical PC with a 17" monitor) draws approximately 110 watts when
powered on.
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Distortion
Sinusoidal waveform, less than 5% THD.
Heat Output
● The iDXA scanner outputs approximately 150 BTU per hour when idle and 1800
BTU per hour when actively scanning.
● The Prodigy and Prodigy Advance scanners output 150 BTU per hour when idle
and 1500 BTU per hour when actively scanning.
● The DPX NT/Pro/MD+/Duo/Bravo scanners output 90 BTU per hour when idle and
approximately 900 BTU per hour when actively scanning.
● The host PC (typical PC with 17" monitor) outputs approximately 400 BTU per hour
when powered on.
Static Electricity
Install and operate the system in a static-free area. Adhere to minimum humidity
requirements to prevent malfunctions caused by static electricity.
Temperature
Make sure the temperature during system operation is 65°F-81°F (18°C-27°C).
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Elevation
Lunar scanners are not for use above 3000 m.
Humidity
0% to 95% non-condensing.
Atmospheric pressure
500 to 1060 hPa.
Temperature
-30° to 65° C.
Space Requirements
For safety reasons, the computer and all peripherals must be in the same room
with the scanner. Consult local regulations on radiation safety. Scanners should be
separated from MR equipment so the field is <1 Gauss.
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Small room configuration: Room dimensions must be at least 3.2 m x 3.35 m (10.5
ft x 11 ft) if the computer and peripherals are powered by an isolation transformer.
Equipment powered by an isolation transformer can be located anywhere in the
room with the scanner.
iDXA full size table, small room configuration
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DPX Duo
Standard room configuration: The computer and all peripherals must be located
more than 1.5 m or 1.83 m (U.S.A and Canada) from the scanner. Recommended room
dimensions are 2.3 meters x 3.7 meters (7.5 feet x 12 feet).
Small room configuration: Room dimensions must be at least 2.4 m x 2.8 m (8 feet
x 9 feet) if the computer and peripherals are powered by an isolation transformer.
Equipment powered by an isolation transformer can be located anywhere in the
room with the scanner.
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Leakage Current
Computer and peripherals with isolation transformer: <100 microamperes.
Scanner table alone: <500 microamperes.
Input Power
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Voltage and frequency shall be appropriate for country of installation. UPS must be
redundantly grounded to the wall outlet.
If the UPS is provided by GE Healthcare, it will meet all of the requirements above.
Fuse Capability
DPX Series: 3.15 A.
Prodigy Series: 3.15 A.
Lunar iDXA Series: No serviceable fuse.
Collimator Specifications
Lunar iDXA Series
Operation Voltage Power (W) Input Power
(VDC)
10 2.8 Model: GEBEL2374276
Input Voltage: 100-127 VAC; 200-240 VAC,
50/60 Hz; 750VA
Output Voltage: 10VDC @ 0.28A
Prodigy Series
Operation Voltage Power (W) Input Power
(VDC)
12 4 Model: GLM75P
Input Voltage: 100-240VAC; 50/60 Hz; 3.1 A
Output Voltage:24vDC @4A; 12VDC @ 2.5A,
-12VDC@1A; 5V@8A
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DPX Series
Operation Voltage Power (W) Input Power
(VDC)
12 3.5 Model: GLM75P
Input Voltage: 100-240VAC; 50/60 Hz; 3.1 A
Output Voltage:24vDC @4A; 12VDC @ 2.5A,
-12VDC@1A; 5V@8A
Mains frequency 45 - 66 Hz
Model 40782
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Prodigy Series
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DPX Series
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Anode heating and cooling curves Refer to Prodigy Series, DPX NT/Pro/MD+/
Bravo/Duo Anode heating/cooling curves
(293)
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X-ray tube assembly heating and cooling Refer to Prodigy Series, DPX NT/Pro/MD+/
curves Bravo/Duo X-Ray Tube Assembly Heating
and Cooling Curves (296)
Maximum continuous heat dissipation 243 Watts (3mA x 76kV + 15W filament)
Maximum symmetrical radiation field 3.4 mm/19.5 mm at a distance from the focal
spot of 223 mm
Weight 8.6 kg
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X-ray tube assembly heating and cooling Refer to Prodigy Series, DPX NT/Pro/MD+/
curves Bravo/Duo X-Ray Tube Assembly Heating
and Cooling Curves (296)
Maximum continuous heat dissipation 129 Watts (1.5mA x 76kV + 15W filament)
Weight 8.6 kg
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Prodigy Series
● AP Spine measurements: 42 cm x 22 cm
● Femur measurements: 20.2 cm x 20 cm (53.8 x 20 cm with AFF feature)
● Orthopedic Hip measurements: 45.4 cm x 20 cm
● Total Body measurements (full-size tables only): 197.7 cm x 60 cm measurement
field
● Forearm measurements: 42 cm x 10 cm
● Lateral Spine measurements: 58.8 cm x 22 cm
DPX NT/Pro/MD+
● AP Spine measurements: 43 cm x 22 cm
● Femur measurements: 21 cm x 20 cm
● Orthopedic Hip measurements: 46 cm x 20 cm
● Total Body measurements (full-size tables only): 195 cm x 60 cm measurement field
● Forearm measurements: 43 cm x 10 cm
● Lateral Spine measurements: 59 cm x 22 cm
DPX Duo/Bravo
● AP Spine measurements: 43 cm x 22 cm
● Femur measurements: 21 cm x 20 cm
● Orthopedic Hip measurements: 46 cm x 20 cm
● Forearm measurements: 43 cm x 10 cm
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Typical
Measurement Estimated Skin
Current Area (L cm x Irradiation Entrance Dose
Site ModeA (mA)B W cm)D,E Time (sec)C,D,E (μGy)F,G
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Typical
Measurement Estimated Skin
Current Area (L cm x Irradiation Entrance Dose
Site ModeA (mA)B W cm)D,E Time (sec)C,D,E (μGy)F,G
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Typical
Measurement Estimated Skin
Current Area (L cm x Irradiation Entrance Dose
Site ModeA (mA)B W cm)D,E Time (sec)C,D,E (μGy)F,G
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Typical
Measurement Estimated Skin
Current Area (L cm x Irradiation Entrance Dose
Site ModeA (mA)B W cm)D,E Time (sec)C,D,E (μGy)F,G
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Prodigy series
Prodigy, Prodigy Advance, Prodigy Pro current and typical dose
Typical
Measurement Estimated
Current Area (L cm x Irradiation Skin Entrance
Site Mode1 (mA)2 W cm)4,5 Time (sec)3,4,5 Dose (μGy)6,7
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Typical
Measurement Estimated
Current Area (L cm x Irradiation Skin Entrance
Site Mode1 (mA)2 W cm)4,5 Time (sec)3,4,5 Dose (μGy)6,7
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Typical
Measurement Estimated
Current Area (L cm x Irradiation Skin Entrance
Site Mode1 (mA)2 W cm)4,5 Time (sec)3,4,5 Dose (μGy)6,7
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Typical
Measurement Estimated
Current Area (L cm x Irradiation Skin Entrance
Site Mode1 (mA)2 W cm)4,5 Time (sec)3,4,5 Dose (μGy)6,7
Typical Mea-
surement Irradiation Estimated
Current Area (L cm times Skin Entrance
Site Mode1 (mA)2 x W cm)4,5 (sec)3,4,5 Dose (μGy)6,7
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Typical Mea-
surement Irradiation Estimated
Current Area (L cm times Skin Entrance
Site Mode1 (mA)2 x W cm)4,5 (sec)3,4,5 Dose (μGy)6,7
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Typical Mea-
surement Irradiation Estimated
Current Area (L cm times Skin Entrance
Site Mode1 (mA)2 x W cm)4,5 (sec)3,4,5 Dose (μGy)6,7
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DPX Series
DPX NT/Pro/Duo/Bravo current and typical dose
Typical Mea-
surement Estimated
Current Area (L cm Irradiation Skin Entrance
Site Mode1 (mA)2 x W cm)4,5 times (sec)3,4,5 Dose (μGy)6,7
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Typical Mea-
surement Estimated
Current Area (L cm Irradiation Skin Entrance
Site Mode1 (mA)2 x W cm)4,5 times (sec)3,4,5 Dose (μGy)6,7
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Typical Mea-
surement Estimated
Current Area (L cm Irradiation Skin Entrance
Site Mode1 (mA)2 x W cm)4,5 times (sec)3,4,5 Dose (μGy)6,7
Typical Mea-
surement Estimated
Current Area (L cm Irradiation Skin Entrance
Site Mode1 (mA)2 x W cm)4,5 Times (sec)3,4,5 Dose (μGy)6,7
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5Measurement lengths and times are dependent on patient height and product
version.
6 Dose measurements are constrained by Daily QA limits. For example, the maximum
spine (standard mode) range is 8 to 28 μGy for DPX series bone densitometers. To
simulate an average patient, 10 cm of acrylic is used for back-scatter material.
7 Irradiation times and dose values do not consider a “sweep retry” feature, which can
double the dose for a single transverse sweep within an entire scan. If a retry occurs,
a slight increase in irradiation time and skin entrance dose would be expected. On
DPX series scanners running version 8 software and newer, a sweep may be retried
one time during acquisition. A maximum of two sweeps can be retried per scan. The
retry feature reduces the need to rescan the entire patient.
Electromagnetic Interference
Although the scanner meets safety standards regarding electromagnetic interference
(EN60601-1-2), you may still experience a loss of performance under extreme
electromagnetic conditions. Maximize the distance between the scanner and other
equipment. Use a dedicated power line to avoid interference to and from the scanner.
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RF emissions
CISPR 11 Class A The bone densitometer is suitable
for use in all establishments,
Harmonic emissions Class A other than domestic, and those
IEC 61000-3-2 directly connected to the public
low-voltage power supply network
Voltage fluctuations / flicker Complies that supplies buildings used for
emissions domestic purposes.
IEC 61000-3-3 Caution: This equipment is not
intended for use in residential
envrionments and may not provide
adequate protection to radio
reception in such environments.
The EMISSIONS characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for
which CISPR 11 class B is normally required) this equipment might not offer adequate
protection to radio-frequency communication services. The user might need to take
mitigation measures, such as relocating or re-orienting the equipment.
Immunity test IEC 60601 test Compliance level Electromagnetic environment guidance
level
Electrostatic DPX Series: DPX Series: Floors should be wood, concrete or ceramic
discharge (ESD) ±6 kV contact ±6 kV contact tile. If floors are covered with synthetic
IEC 61000-4-2 material, the relative humidity should be at
±8 kV air ±8 kV air least 30 %.
iDXA, Prodigy iDXA, Prodigy
Series: Series:
±8 kV contact ±8 kV contact
±15 kV air ±15 kV air
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be that of a
transient/burst supply lines supply lines typical commercial or hospital environment.
IEC 61000-4-4 ±1 kV for ±1 kV for
input/output lines input/output lines
Surge ±1 kV line to line ±1 kV line to line Mains power quality should be that of a
IEC 61000-4-5 ±2 kV line to earth ±2 kV line to earth typical commercial or hospital environment.
Voltage dips, short <5 % UT (>95 % dip <5 % UT (>95 % dip If the user of the bone densitometer requires
interruptions and in UT) for 1 cycle in UT) for 1 cycle continued operation during power mains
voltage variations 70 % UT (30 % dip 70 % UT (30 % dip interruptions, it is recommended that the
on power supply in UT) for 25 cycles in UT) for 25 cycles bone densitometer be powered from an
input lines uninterruptible power supply.
<5 % UT (>95 % dip <5 % UT (>95 % dip
IEC 61000-4-11 in UT) for 5 s in UT) for 5 s
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Note 1: UT is the A.C. mains voltage prior to application of the test level.
Note 2: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
This equipment is suitable for use in industrial areas and hospitals (except for
near active HF surgical equipment and the RF shielded room of an MRI, where
electromagnetic disturbances are high). Loss of performance (inaccurate bone density
results) due to electromagnetic disturbances may be indicated by artifacts within
scan images or failure of quality assurance tests. If such indicators are encountered,
increase the distance between RF generating equipment and the bone densitometer.
WARNING
Use of the bone densitometer adjacent to or stacked with other equipment should be
avoided. Use of accessories and cables other than those provided by GE Healthcare
could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment. Portable RF communications equipment (including
peripherals such as antenna cables and external antennas) should be used no closer
than 30 cm (12 inches) to any part (including cables) of the bone densitometer. Failure
to do so could result in improper operation.
Minimum PC Requirements
The enCORE computer must meet the requirements listed in this section.
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Keyboard/Mouse USB
RAM 2 GB
Audio Optional
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Item Requirement
Keyboard/Mouse USB
RAM 2 GB
Audio Optional
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Item Requirement
Keyboard/Mouse USB
RAM 2 GB
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Item Requirement
Audio Optional
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Reference Data
B
enCORE Reference Data
enCORE reference data are based on healthy, ambulatory subjects from the general
population who were free from chronic diseases affecting bone, and not taking
bone-altering medications. The first section describes how reference data are
displayed during analysis. The principles described in this section apply in general to
all skeletal regions. The second section describes the reference data in detail. Use of
reference data is entirely at the discretion of the clinician. Unless otherwise noted, all
values used as examples apply to female USA (Lunar) reference data.
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female femur (neck, troch, total) and male femur (total) reference data from the
NHANES III study. Other regions and scan sites use USA Lunar reference data.
● USA (NHANES 1999-2004). Contains adult and pediatric total body reference data
from the NHANES study conducted from 1999 to 2004 based on a representative
sample of the U.S. population.
Other available reference populations are: Asia, Australia (Combined Geelong/Lunar),
Australia (Geelong), Australia (Lunar), Brazil, China, Egypt, Finland, France, Germany,
Indonesia, Italy, Japan (JSBMR 2011), Japan (Lunar), Korea, Mexico, Middle East,
Philippine, Spain, Tunisia, Turkey, and UK.
2. The measurement sites are listed in the Sites section of the dialog box. Choose a
site by clicking the site name.
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3. Select the reference population you want to use from the list of Available
Reference Populations.
The Available Reference Populations list lets you choose the reference population
to which your patient data will be compared. A different reference population can
be selected independently for each measurement site, or the Use same Reference
Population for all sites option lets you use the same population for all sites.
Enable this option to use the currently selected reference population for all sites.
4. The Default Region list lets you choose the default region for analysis for each site.
5. Choose the reference population options you want to use by checking the boxes
in the Reference Settings section.
The available options are site-specific:
● Young Adult (T-score) allows comparison to the reference population mean
value for a healthy young adult of the same sex as the patient. When this
option is selected, you can access the %Young Adult and T-score data during
analysis.
● Age Matched (Z-score) allows comparison to the reference population subjects
of the same age and sex as the patient. When this option is selected, you can
access the %Age-Matched and Z-score data and the Age Matched regression
bar during analysis.
● Ethnic Adjustment factors ethnic origin (Black, White, Asian, or Hispanic) into
the age-matched comparison. This option is not available for Lateral Vertebral
Assessment (LVA). You can only use this option if the Age Matched (Z-score)
option is selected.
● Height Adjustment is only available for the LVA site. When this option is
selected, the subject’s vertebral heights are normalized by the ratio of the
reference population’s average L2-L4 height to the subject’s average L2-L4
height and then compared with the reference heights at each level. This option
is selected whenever the Age Matched (Z-score) option is selected and cannot
be disabled.
● Weight Adjustment adjusts the age-matched comparison for the patient’s
weight. This option is not available for the LVA site. Weight adjustment is only
possible if the Age Matched (Z-score) option is selected.
6. Click OK to save the changes.
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The following paragraphs describe the features in the dialog box. When a feature is
selected, that feature appears on the graph.
● Standard Deviation Bars lets you turn the standard deviation bars on and off.
These bars are the colored bars that appear on the graph.
● Show Secondary Y-Axis lets you turn the y-axis on the right side of the reference
graph on and off. The secondary y-axis shows the YA T-score or AM Z-score when
applicable.
● Center Line determines if a centerline appears in the Age-Matched regression bar.
The centerline marks the average BMD value.
● 1st Bar and 2nd Bar let you choose how many Age-Matched regression bars to
display (±1 SD or ±2 SD). Check one box to display one regression bar (e.g., ±1 SD or
±2 SD) or both boxes to display two (e.g., ±1 SD and ±2 SD).
● The Solid check box next to each bar option determines the color of the regression
bar. If selected, the bar is blue. Otherwise, the bar is clear.
● The SD text boxes let you set the standard deviation for each bar. A 1.00 SD means
the bar extends 1 SD above and 1 SD below the centerline. To change an SD value,
click inside the appropriate text box, delete the old value, and enter the new value.
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Femur Densitometry X X X1 X X X
Forearm Densitometry X X X X X
Pediatric Growth X X X
AP Spine Densitometry X1 X X X X
Femur Densitometry X1 X X X X
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Forearm Densitometry X1 X X X
Pediatric Growth X X
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Forearm Densitometry X X X X
Pediatric Growth X
AP Spine Densitometry X1 X X1 X X
Femur Densitometry X1 X X1 X X
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Forearm Densitometry X1 X X
Pediatric Growth X X
AP Spine Densitometry X X X X
Femur Densitometry X X X X
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Forearm Densitometry X X X X
1 Females only
2 Asians only
3 The data supports comparisons to both BMD and BMC (BMC for Basic Analysis only)
4 Whites only
6 No TBLH support
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Adult Reference Data
C
Bone Mineral Density (BMD)
The bone mineral density (BMD) value gives the area density in g/cm2 for a selected
region. enCORE software plots a patient’s BMD versus age on the Reference graph.
The figure below shows a 70-year old female patient with a spine BMD value of 0.990
g/cm2. Numerical divisions on the right and left sides of the graph correspond to
intervals of one standard deviation (SD).
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Female reference graph with Age-Matched regression bar for 70- year old patient
%Young Adult
The %Young Adult (%YA) value compares a patient’s BMD with the expected Young
Adult (YA) BMD for a subject 20-39 years old of the same sex and nationality. Young
adult reference values are set at age 30 for all but Australia/Geelong and NHANES
reference data, which are set at age 25 years. The green bars at the top of the
graph show the normal range of spine L1-L4 BMD values for young adults. For USA
white females, the YA Spine BMD value is 1.18 g/cm2. Each change in BMD shown
at the left of the graph represents one standard deviation (SD) from the YA BMD.
These values correspond to the SD changes noted on the right axis of the graph.
The standard deviation for an adult white female AP (anteroposterior) spine L1-L4 is
0.12 g/cm2. Notice that the BMD value below 1.18 at the left of the graph is 1.06,
representing 1 SD below the YA value. This agrees with the –1 noted on the right axis.
The table accompanying the graph shows that this patient’s BMD is 84% of the YA
BMD (0.990/1.18 = 84%).
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The program also calculates the patient’s Young Adult T-score. The T-score is the
number of SDs the patient’s BMD is above or below the Young Adult mean value. The
patient plotted in Bone Mineral Density (BMD) (339) has a T-score of –1.6, indicating
the patient’s BMD value is 1.6 SDs below the Young Adult mean value ((0.990 –
1.18)/0.12 = -1.6).
%Age-Matched
The %Age-Matched value compares the subject’s BMD with the average BMD of a
reference group of the same age and sex, and, optionally, with the same weight and
ethnicity. This Age-Matched comparison is displayed as the regression bar on the
Reference graph. The regression bar refers to the area that begins as light green,
with upper and lower limits of 1.3 and 1.06 BMD in Bone Mineral Density (BMD) (339).
The Age-Matched comparison is used to determine if the patient deviates from the
reference pattern for the patient’s age, sex, and, optionally, weight and/or ethnicity.
The line in the middle of the bar marks the expected BMD value at each age. The
areas above and below the centerline indicate one SD above and below the mean
BMD for any age.
The graph shows there is little change in lumbar spine BMD until age 45, when a
decrease begins. This age-related decline must be factored into the final analysis of
the patient’s results. A BMD value that falls below the Age-Matched bar suggests that
factors other than aging may be affecting the patient’s BMD value. The program also
calculates the patient’s Age-Matched Z-score. The Z-score is the number of SDs the
patient’s BMD is above or below the Age-Matched mean value. The subject’s BMD
plotted in Bone Mineral Density (BMD) (339) has a Z-score of 0.1, because the BMD
value of 0.990 is 0.1 SDs above the Age-Matched mean value of 0.978 g/cm2 for a
70-year old woman ((0.990-0.978)/0.12 = 0.10). This value means that this subject’s
BMD is near average for her age.
The figure below shows a 45–year-old subject who has the same BMD (0.990g/cm2)
as the 70-year-old female shown in Bone Mineral Density (BMD) (339). Unlike the
70-year-old patient who is within the Age-Matched regression bar and, thus, has
normal BMD for her age, the 45-year-old patient is well below the bar, indicating that
factors other than aging may be causing her bone loss. Secondary causes of bone
loss include a variety of endocrine disorders, eating disorders, gastrointestinal and
liver disorders, cancer, kidney disease, bone marrow-related disorders and adverse
effects of drug therapy.110, 111
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The figure below shows a patient with the same BMD results as before, but the patient
now weighs 85 kg rather than 65 kg. Notice the Age-Matched regression bar has
shifted up to adjust for this additional weight. The peak Age-Matched BMD for age
20-45 that previously was 1.18 g/cm2 is now 1.26 g/cm2 (1.18 + (85-65) x 0.004 = 1.26).
AP spine and femur adjustments are applied for weights between 25 and 100 kg.
Data suggest an additional weight adjustment for subjects over 100 kg or less than
25 kg is not necessary.
Female reference graph with Age-Matched regression for weight set at 85 kg
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The Ethnicity adjustment within a reference population should not be confused with
specific, nationality-based reference data (e.g., China, USA).
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normal limits of nutrition and physical activity have not been demonstrated to have a
significant influence on reference values, but body weight does have some influence.1,
8-12 Race also can have an influence on BMD. For example, BMD in black subjects is
about 8-12% more dense than in white subjects.13-22 Hispanics have a somewhat
higher BMD (2-4%) than whites.20, 23 People of Asian descent have somewhat lower
BMD than black or Caucasian subjects, a finding that is at least partly associated
with smaller body size.24-26
Comparison to Age-Matched
Bone mass and density decrease with aging in males and females. The exact
magnitude of the effect cannot be assessed from studies of cross-sectional data in
groups because of inter-individual variation. Longitudinal studies of individual females
usually show a consistent progression of losses following menopause.27-48 Data from
the USA (Lunar) reference population are plotted in the figures below and listed in the
tables in Age Adjustment (350).
Male and female USA (Lunar) reference values for spine L1-L4
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Male and female USA (Lunar) reference values for femur neck and total BMD
USA (Combined NHANES/Lunar) reference values for femur neck and total femur reference values
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Male and female USA (Lunar) reference values for Total Body BMD
Male and female USA (Lunar) reference values for Radius 33% Shaft and Radius Total BMD
Male and female USA (Lunar) age-related reference for lateral L2-L3 body
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Age Adjustment
Age-Matched comparisons use age regressions to calculate an expected BMD. The
subject’s BMD is compared with the expected BMD for a person of the same age and
gender in the reference population. Age-Matched BMD reference values are shown in
the tables below, broken out by decade.
Reference Values for Spine
Female reference values for Spine L1-L4
Female YA BMD, SD, and reference values at 10-year intervals for AP Spine (L1-L4).
YA SD 25 yr 35 yr 45 yr 55 yr 65 yr 75 yr 85 yr
Asia 1.112 0.12 1.112 1.112 1.112 0.992 0.872 0.807 0.797
Australia/ 1.207 0.1324 1.207 1.207 1.207 1.135 1.063 0.994 0.925
Geelong
USA/N. Europe 1.180 0.12 1.180 1.180 1.180 1.085 0.990 0.970 0.950
China 1.114 0.12 1.114 1.114 1.114 0.991 0.868 0.792 0.762
Egypt 1.150 0.12 1.150 1.150 1.150 1.050 0.950 0.940 0.930
Finland 1.170 0.12 1.170 1.170 1.170 1.045 0.920 0.900 0.880
France 1.160 0.12 1.160 1.160 1.105 0.995 0.885 0.855 0.825
Indonesia 1.110 0.12 1.110 1.110 1.110 1.025 0.940 0.878 0.816
Italy 1.180 0.12 1.180 1.180 1.130 1.030 0.930 0.900 0.870
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YA SD 25 yr 35 yr 45 yr 55 yr 65 yr 75 yr 85 yr
Japan (JSBMR 1.152 0.139 1.152 1.152 1.152 0.999 0.887 0.817 0.747
2012)
Japan (Lunar) 1.110 0.12 1.110 1.110 1.110 0.990 0.870 0.840 0.810
Korea 1.149 0.12 1.149 1.149 1.149 1.051 0.953 0.843 0.733
Mexico 1.170 0.12 1.170 1.170 1.120 1.020 0.920 0.895 0.870
Middle East 1.101 0.12 1.101 1.101 1.101 1.021 0.941 0.931 0.921
Philippines 1.110 0.12 1.110 1.110 1.110 0.988 0.866 0.835 0.804
Spain 1.180 0.12 1.180 1.180 1.130 1.030 0.930 0.900 0.870
Tunisia 1.148 0.12 1.148 1.148 1.148 1.018 0.888 0.858 0.828
Turkey 1.136 0.12 1.136 1.136 1.136 1.056 0.976 0.906 0.836
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YA SD 25 yr 35 yr 45 yr 55 yr 65 yr 75 yr 85 yr
Japan 1.138 0.162 1.138 1.138 1.138 1.110 1.082 0.983 0.884
(JSBMR 2012)
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YA SD 25 yr 35 yr 45 yr 55 yr 65 yr 75 yr 85 yr
France 1.000 0.12 1.005 0.995 0.951 0.872 0.793 0.731 0.669
Indonesia 0.943 0.12 0.943 0.943 0.943 0.871 0.799 0.723 0.647
Italy 1.000 0.12 1.005 0.995 0.985 0.921 0.857 0.802 0.747
Japan (JSBMR 0.961 0.130 0.961 0.948 0.921 0.868 0.787 0.707 0.627
2012)
Japan (Lunar) 0.934 0.12 0.940 0.929 0.918 0.823 0.728 0.676 0.624
Korea 0.974 0.12 0.974 0.974 0.974 0.937 0.862 0.752 0.642
Mexico 1.010 0.12 1.025 0.995 0.965 0.918 0.871 0.824 0.777
Middle East 0.940 0.12 0.945 0.935 0.925 0.891 0.857 0.814 0.771
NHANES 1.0077 0.126 1.008 0.990 0.972 0.927 0.858 0.790 0.722
Philippines 0.913 0.12 0.913 0.913 0.913 0.863 0.813 0.768 0.723
Spain 1.000 0.12 1.005 0.995 0.985 0.921 0.857 0.802 0.747
Tunisia 1.0414 0.13 1.041 1.041 1.041 0.986 0.876 0.791 0.731
Turkey 0.97725 0.12 0.982 0.972 0.962 0.952 0.882 0.787 0.692
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YA SD 25 yr 35 yr 45 yr 55 yr 65 yr 75 yr 85 yr
Finland 1.090 0.13 1.105 1.075 1.045 1.020 0.995 0.965 0.935
France 1.035 0.13 1.055 1.016 0.977 0.945 0.913 0.874 0.835
Indonesia 1.003 0.13 1.013 0.993 0.973 0.955 0.937 0.875 0.813
Italy 1.090 0.13 1.110 1.071 1.032 1.000 0.968 0.929 0.890
Japan (JSBMR 1.046 0.135 1.046 1.027 0.990 0.952 0.914 0.839 0.763
2012)
Japan (Lunar) 0.941 0.13 0.961 0.922 0.883 0.851 0.819 0.780 0.741
Korea 0.941 0.13 0.961 0.922 0.883 0.851 0.819 0.780 0.741
Mexico 1.090 0.13 1.125 1.055 0.985 0.970 0.955 0.935 0.915
Middle East 1.034 0.13 1.054 1.015 0.976 0.951 0.926 0.859 0.792
NHANES 1.101 0.144025 1.101 1.082 1.062 1.043 1.024 0.975 0.905
Spain 1.090 0.13 1.110 1.071 1.032 1.000 0.968 0.929 0.890
Turkey 1.034 0.13 1.054 1.015 0.976 0.951 0.926 0.859 0.792
USA/N. Europe 1.125 0.08 1.125 1.125 1.125 1.075 1.025 1.005 0.985
China 1.120 0.10 1.120 1.120 1.098 1.054 1.004 0.948 0.892
Finland 1.125 0.08 1.125 1.125 1.125 1.075 1.025 1.005 0.985
France 1.077 0.08 1.077 1.077 1.077 1.037 0.997 0.979 0.961
Italy 1.110 0.08 1.110 1.110 1.110 1.070 1.030 1.012 0.994
Japan (Lunar) 1.100 0.08 1.100 1.100 1.100 1.015 0.930 0.895 0.860
Korea 1.100 0.08 1.100 1.100 1.100 1.015 0.930 0.895 0.860
Spain 1.110 0.08 1.110 1.110 1.110 1.070 1.030 1.012 0.994
Turkey 1.132 0.08 1.132 1.132 1.132 1.107 1.057 0.980 0.903
Female reference values for Total Body BMD — Enhanced Analysis (Prodigy, iDXA)
YA SD 25 yr 35 yr 45 yr 55 yr 65 yr 75 yr 85 yr
Asia 1.062 0.11 1.062 1.062 1.062 0.971 0.880 0.826 0.771
USA/N. Europe 1.080 0.10 1.080 1.080 1.080 1.017 0.954 0.929 0.904
China 1.074 0.13 1.074 1.074 1.046 0.991 0.928 0.857 0.787
Finland 1.080 0.10 1.080 1.080 1.080 1.017 0.954 0.929 0.904
France 1.020 0.10 1.020 1.020 1.020 0.969 0.919 0.896 0.874
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YA SD 25 yr 35 yr 45 yr 55 yr 65 yr 75 yr 85 yr
Italy 1.062 0.10 1.062 1.062 1.062 1.011 0.961 0.938 0.915
Japan (Lunar) 1.049 0.10 1.049 1.049 1.049 0.942 0.835 0.790 0.746
Korea 1.049 0.10 1.049 1.049 1.049 0.942 0.835 0.790 0.746
Spain 1.062 0.10 1.062 1.062 1.062 1.011 0.961 0.938 0.915
Turkey 1.089 0.10 1.089 1.089 1.089 1.058 0.995 0.898 0.800
Male reference values for Total Body BMD – Basic Analysis (Prodigy, DPX-NT)
YA SD 25 yr 35 yr 45 yr 55 yr 65 yr 75 yr 85 yr
Asia 1.154 0.09 1.158 1.150 1.135 1.112 1.089 1.066 1.043
USA/N. Europe 1.220 0.08 1.220 1.220 1.220 1.220 1.195 1.170 1.145
China 1.128 0.10 1.132 1.124 1.116 1.113 1.110 1.107 1.104
Finland 1.220 0.08 1.220 1.220 1.220 1.220 1.195 1.170 1.145
Japan (Lunar) 1.180 0.08 1.180 1.180 1.158 1.113 1.068 1.023 0.978
Korea 1.180 0.08 1.180 1.180 1.158 1.113 1.068 1.023 0.978
Turkey 1.220 0.08 1.220 1.220 1.220 1.220 1.195 1.170 1.145
Male reference values for Total Body BMD – Enhanced Analysis (Prodigy, iDXA)
YA SD 25 yr 35 yr 45 yr 55 yr 65 yr 75 yr 85 yr
Asia 1.117 0.11 1.122 1.112 1.093 1.064 1.035 1.006 0.977
USA/N. Europe 1.200 0.10 1.200 1.200 1.200 1.200 1.169 1.137 1.106
China 1.084 0.13 1.089 1.079 1.069 1.065 1.062 1.058 1.054
Finland 1.200 0.10 1.200 1.200 1.200 1.200 1.169 1.137 1.106
Japan (Lunar) 1.150 0.10 1.150 1.150 1.122 1.065 1.009 0.952 0.895
Korea 1.150 0.10 1.150 1.150 1.122 1.065 1.009 0.952 0.895
Turkey 1.200 0.10 1.200 1.200 1.200 1.200 1.169 1.137 1.106
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YA SD 25 yr 35 yr 45 yr 55 yr 65 yr 75 yr 85 yr
Middle East 0.8209 0.08875 0.821 0.821 0.821 0.790 0.728 0.665 0.603
Philippines 0.8110 0.08875 0.816 0.807 0.798 0.736 0.674 0.629 0.584
Spain 0.88747 0.08875 0.887 0.887 0.887 0.847 0.767 0.687 0.607
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YA SD 25 yr 35 yr 45 yr 55 yr 65 yr 75 yr 85 yr
Finland 1.002 0.10025 1.002 1.002 1.002 0.982 0.942 0.902 0.862
France 1.002 0.10025 1.002 1.002 1.002 0.982 0.942 0.902 0.862
Italy 1.002 0.10025 1.002 1.002 1.002 0.982 0.942 0.902 0.862
Japan (Lunar) 0.960 0.10025 0.960 0.960 0.937 0.892 0.847 0.802 0.757
Korea 0.960 0.10025 0.960 0.960 0.937 0.892 0.847 0.802 0.757
Middle East 0.945 0.10025 0.945 0.945 0.945 0.933 0.908 0.871 0.833
Spain 1.002 0.10025 1.002 1.002 1.002 0.982 0.942 0.902 0.862
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Weight Adjustment
Age-Matched comparisons can be adjusted for body weight by selecting the Weight
Adjustment default in the software. Increased weight is associated with higher BMD
values. Conversely, decreased weight is associated with lower BMD values. A weight
adjustment is applied for subjects who weigh between 25 and 100 kg and weigh
more or less than the mean weight. The mean weights are 65 kg for women and 78
kg for men in the USA (Lunar) database.
● AP Spine BMD weight adjustment per kilogram is 0.004g/cm2 (see table below).
● Femur BMD (Neck, Trochanter and Total) weight adjustment per kilogram is 0.003
g/cm2.
● The weight adjustment per kilogram for the Total Body BMD is 0.0035g/cm2.
BMD weight regression for reference females
Site Regression r SEE (g/cm2)
AP Spine BMD = 0.845 + 0.004 x Weight) 0.14 0.184
Femur Neck BMD = 0.670 + (0.003 x Weight) 0.28 0.134
Femur Trochanter BMD = 0.460 + (0.003 x Weight) 0.40 0.111
Total Body BMD = 0.886 + (0.0035 x Weight) 0.47 0.083
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This figure shows the Table of Z-scores with an AP Ratio Z-score of –4.8 for T11, well
beyond the Z-score threshold of –3 that the program highlights as a deformity or
fracture.
Morphometry table showing severe wedge at T11
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models showed that fracture risk increased 60% for each standard deviation (6 mm)
increase in HAL, consistent with previous results109 Likewise, significant increases in
fracture risk were related to decreased BMD at all femoral measurement sites.
Dual femur image showing HAL and femoral measurement sites
Scans of the proximal femur of 5435 women age 20-96 years (mean age 64.5; SD
11.4 yrs) were analyzed with Lunar Prodigy. The mean (SD) of HAL was 104.4 (5.86)
mm. The measured value for a patient was compared to mean HAL adjusted for
the patient’s height and weight.
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reference values for Indonesian men and women. J Bone Miner Res 21(Suppl
1):S142.
88. Cheng XG, Yang DZ, Zhou Q, Zhuo TJ, Zhang HC, Xiang J, Wang HF, Ou PZ, Liu
JL, Xu L, Huang GY, Huang QR, Barden HS, Weynand LS, Faulkner KG, Meng XW
(2001) DXA bone mineral density reference data for the Chinese population. J Clin
Densitometry8(2):235.
89. Deleze M, Cons-Molina F, Villa AR et al., (2001) Geographic differences in bone
mineral data of Mexican women. Osteoporos Int 11:562-569.
90. Zakraoui L, Laatar A, Kassab S, Nasrooui R, Kerkeni Sm Ben Hamida B, Ben Aissa
R, Zouari B, Gueddana N (2005) Preliminary results of bone mineral density values
in a healthy female population from Tunisia. Presented at the Fifth European
Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis,
March 16-19, Rome, Italy.
91. Torralba TP, Tan-Ong M, Navarra SV, Dy SH, Saavedra SCT, Bermudex CC,
Mercado-Asis L, Llamado LQ, Yu YL (2001) Determination of normative bone
mineral density values in Filipino women. Phil J Intern Med 39:31-37.
92. Xu H, Chen J-X, Gong J, Zhang T-M, Yuan Z-M, Wang J-P (2007) Normal reference
for bone density in healthy Chinese children. J Clin Densitometry 10(3):26-275.
93. Fattah IA, Nadim A, Rashed A (2000) The bone mineral density of the Egyptian
Reference women population. Unpublished manuscript.
94. Runge H, Fengler F, Franke J, Koall W (1980) Ermittlung des peripheren
Knochenmineralgehaltes bei Normalpersonen und Patienten mit verschiedenen
Knochenerkrankungen, bestimmt mit Hilfe der Photonenabsorptionstechnik am
Radius. Radiologe 20:505-514.
95. Minne HW, Leidig G, Wuster C, Siromachkostov L, Baldauf G, Bickel R, Sauer
P, Logen M, Ziegler R (1988) A newly developed spine deformity index (SDI)
to quantitate vertebral crush fractures in patients with osteoporosis. Bone
Miner3:335-349.
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96. Gallagher JC, Hedlund LR, Stoner S, Meeger C (1988) Vertebral morphometry
normative data. Bone Miner4:189-196.
97. Black DM, Cummings SR, Stone K, Hudes E, Palermo L, Steiger P (1991) A new
approach to defining normal vertebral dimensions. J Bone Miner Res 6(8):883-891.
98. Parsons TJ, Prentice A, Smith EA, Cole TJ, Compston JE (1996) Bone mineral mass
consolidation in young British adults. J Bone Miner Res 11:264-274.
99. Davies KM, Recker RR, Heaney RP (1989) Normal vertebral dimensions and normal
variation in serial measurements of vertebrae. J Bone Miner Res 4:341-349.
100.Evans SF, Nicholson PHF, Haddaway MJ, Davie MWJ (1993) Vertebral morphometry
in women aged 50-81 years. Bone Miner 21:29-40.
101.Hermann AP, Brixen K, Andresen J, Mosekilde L (1993) Reference values for
vertebral heights in Scandinavian females and males. Acta Radiol 34:48-52.
102.McCloskey EV, Spector TD, Eyres KS, Fern ED, O’Rourke N, Vasikaran S, Kanis JA
(1993) The assessment of vertebral deformity: a method for use in population
studies and clinical trials. Osteoporos Int 3:138-147.
103.Smith-Bindman R, Cummings SR, Steiger P, Genant HK (1991) A comparison of
morphometric definitions of vertebral fracture. J Bone Miner Res 6:25-34.
104.Young JT, Carter KA, Marion MS, Greendale GA (2000) A simple method of
computing hip axis length using fan-beam densitometry and anthropometric
measurements. J Clin Densitometry3:335-341.
105.Barden HS, Settergren D, McClintock C, Turner CH (2001) Measurement of femur
geometry (HAL) with Prodigy is accurate and unaffected by magnification. J Bone
Miner Res16(Suppl 1):S345.
106.Faulkner KG, Cummings SR, Black D, Palermo L, Gluer CC, Genant HK (1993)
Simple measurement of femoral geometry predicts hip fracture: the Study of
Osteoporotic Fractures. J Bone Miner Res 8:1211-1217.
107.Faulkner KG (2003) Improving femoral bone density measurements. J Clin
Densitometry 6(4):353-358.
108.Faulkner KG, Barden HS, Bui H, Weynand LS, Burke PK (2002) Fan-beam hip axis
length measurements predict hip fracture. J Bone Miner Res17:S152.
109.Faulkner KG, Wacker WK, Barden HS, Simonelli C, Burke PK, Ragi S, Del Rio L (2006).
Femur strength index predicts hip fracture independent of bone density or hip
axis length. Osteoporos Int 17:593-599.
110.Fitzpatrick LA (2002) Secondary causes of osteoporosis. Mayo Clin Proc
77(5):453-458.
111.Painter SE, Kleerekoper M, Camacho PM (2006) Secondary osteoporosis: a review
of recent evidence. Endocr Pract 12(4):436-445.
112.Orimo H, Suigioka Y, Fukunaga M, Muto Y, Hotokebuchi T, Gorai I, Nakamura
T, Kushida K, Tanaka H, Ikai T, Oh-Hashi Y. Diagnostic criteriea of primary
osteoporosis. J Bone Miner Metab 1998; 16:139-150.
113.Osteoporosis Japan 1996; 14(4):65-75.
114.Osteoporosis Japan 2013; vol 21. No 1.
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D
Bone Mineral Density (BMD)
The bone mineral density (BMD) value gives the area density in g/cm2 for a selected
region. enCORE software plots a patient’s BMD versus age on the Reference graph.
The figure below shows an 8.5-year-old female patient with a spine BMD value of
0.667 g/cm2. Numerical divisions on the right side of the graph correspond to intervals
of one standard deviation (SD) above and below the age-matched regression line that
spans the width of the graph from age 5 to age 20 years.
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Female reference graph with Age-Matched regression bar for 8.5-year-old subject
%Age-Matched
The %Age-Matched value compares the subject’s BMD with the average BMD of a
reference group of the same age and sex, and, optionally, ethnicity. This Age-Matched
comparison is displayed as the regression bar (the light green area) on the Reference
graph shown in Bone Mineral Density (BMD) (371). The Age-Matched comparison is
used to determine if the patient deviates from the reference pattern for the patient’s
age, sex, and, optionally, ethnicity. The line in the middle of the bar marks the expected
BMD value at each age. The areas above and below the centerline indicate one SD
above and below the mean BMD for any age.
The graph shows regression bars that indicate an expected gradual increase in
lumbar spine BMD until age 9, followed by a more rapid gain in BMD until age 16,
with no gain thereafter. The program also calculates the patient’s Age-Matched
Z-score. The Z-score is the number of SDs the patient’s BMD is above or below the
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Age-Matched mean value. The subject’s BMD plotted in Bone Mineral Density (BMD)
(371) has a Z-score of –0.3, because the BMD value of 0.667 g/cm2 is 0.3 SDs below
the Age-Matched mean value.
The figure below shows a 12-year-old subject who has the same BMD (0.667) as the
8.5-year-old female shown in Bone Mineral Density (BMD) (371). Unlike the 8.5-year-old
patient who is within the Age-Matched regression bar, and thus has normal BMD for
her age, the 12.5-year-old subject is 2.4 SDs (Z-score or –2.4) below her age-matched
value.
Female Reference Graph with Age-Matched regression (12-year-old subject)
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the regression bar up if the reference population values are greater than those for
white populations, and down if less than white populations. The Ethnicity adjustment
within a reference population should not be confused with specific, nationality-based
reference data (e.g., China, USA).
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BMD. For example, BMD in black subjects is about 5-12% more dense than in white
subjects. People of Asian descent have somewhat lower BMD than black or Caucasian
subjects, a finding that is at least partly associated with smaller body size.
Comparison to Age-Matched
Bone mass and density increase with age in males and female children. Data from
the USA (Lunar) and Bone Mineral Density in Childhood Study (BMDCS) reference
populations are plotted in the figures below and listed in the tables in Age Adjustment
(380)1-8. USA (Lunar) total body reference values include BMD for subjects with (Total
Body) and without the head (Total Body Less Head). Total Body Less Head reference
data are preferred by some researchers because the head makes up such a large
proportion of the total body BMD in children [Xu 2007].
Male and female USA (Lunar) reference values for spine L1-L4
Male and female USA (Lunar) reference values for femur neck and femur total BMD
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Male and female USA (Lunar) reference values for total body and total body less head BMD
White and black male and female USA (BMDCS) spine L1-L4 reference values
White and black male and female USA (BMDCS) femur neck reference values
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White and black male and female USA (BMDCS) total femur reference values
White and black male and female USA (BMDCS) total body reference values
White and black male and female USA (BMDCS) total body BMC reference values
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Age Adjustment
Age-Matched comparisons use age regressions to calculate an expected BMD. The
subject’s BMD is compared with the expected BMD for a person of the same age
and gender in the reference population.
The tables below list female and male BMD or BMC and SD reference values at 1-year
intervals for AP Spine (L1-L4), Femur Neck, Total Femur, Total Body BMD, Total Body
BMD Less Head, and Total Body BMC.
Female reference values for Spine L1-L4 BMD and SD
USA/N. BMDCS BMDCS
Europe White Black
5 yr 0.624
0.064
6 yr 0.644
0.072
7 yr 0.664 0.629 0.669
0.080 0.072 0.076
8 yr 0.684 0.657 0.705
0.087 0.074 0.076
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Female reference values for Total Body BMD and SD– Basic Analysis (Prodigy, DPX-NT)
USA/N. Europe BMDCS White BMDCS Black China/Asia
5 yr 0.793 0.760
0.022 0.037
6 yr 0.806 0.772
0.036 0.037
7 yr 0.819 0.772 0.822 0.784
0.049 0.048 0.044 0.039
8 yr 0.832 0.805 0.854 0.796
0.059 0.048 0.045 0.043
9 yr 0.845 0.838 0.886 0.808
0.068 0.051 0.048 0.048
10 yr 0.885 0.871 0.918 0.820
0.075 0.055 0.053 0.054
11 yr 0.925 0.904 0.967 0.860
0.081 0.060 0.059 0.061
12 yr 0.965 0.960 1.016 0.900
0.084 0.065 0.066 0.068
13 yr 1.005 1.016 1.065 0.940
0.086 0.069 0.073 0.075
14 yr 1.045 1.072 1.114 0.980
0.086 0.071 0.079 0.080
15 yr 1.085 1.096 1.134 1.020
0.084 0.072 0.086 0.085
16 yr 1.125 1.120 1.154 1.060
0.081 0.069 0.091 0.087
17 yr 1.125 1.060
0.076 0.087
18 yr 1.125 1.060
0.070 0.084
19 yr 1.125 1.060
0.063 0.079
Female reference values for Total Body BMD and SD– Enhanced Analysis (Prodigy, iDXA)
USA/N. Europe BMDCS White BMDCS Black China/Asia
5 yr 0.662 0.620
0.028 0.047
6 yr 0.678 0.635
0.045 0.047
7 yr 0.695 0.635 0.698 0.650
0.062 0.061 0.055 0.049
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Female reference values for Total Body Less Head BMD and SD – Basic Analysis (Prodigy, DPX-NT)
USA/N. Europe China/ Asia
5 yr 0.622 0.538
0.044 0.037
6 yr 0.648 0.570
0.052 0.037
7 yr 0.674 0.602
0.059 0.040
8 yr 0.700 0.634
0.066 0.045
9 yr 0.726 0.666
0.072 0.050
10 yr 0.767 0.698
0.077 0.057
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Female reference values for Total Body Less Head BMD and SD – Enhanced
Analysis (Prodigy, iDXA)
USA/N.
Europe
5 yr 0.498
0.048
6 yr 0.546
0.052
7 yr 0.595
0.058
8 yr 0.643
0.064
9 yr 0.692
0.071
10 yr 0.740
0.079
11 yr 0.789
0.088
12 yr 0.837
0.098
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USA/N.
Europe
13 yr 0.886
0.109
14 yr 0.934
0.120
15 yr 0.953
0.106
16 yr 0.958
0.095
17 yr 0.963
0.090
18 yr 0.968
0.089
19 yr 0.973
0.088
Female reference values for Total Body BMC and SD – Basic Analysis (Prodigy, DPX-NT)
BMDCS White BMDCS Black
5 yr
6 yr
7 yr 811 880
126 119
8 yr 913 1020
125 133
9 yr 1015 1160
148 157
10 yr 1117 1300
188 189
11 yr 1376 1560
236 225
12 yr 1635 1820
284 264
13 yr 1894 2080
324 302
14 yr 2153 2340
347 337
15 yr 2273 2439
345 366
16 yr 2393 2538
310 385
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Male reference values for Total Body BMD and SD – Basic Analysis (Prodigy, DPX-NT)
USA/N. Europe BMDCS White BMDCS China/ Asia
Black
5 yr 0.780 0.761
0.042 0.046
6 yr 0.800 0.775
0.043 0.045
7 yr 0.820 0.797 0.853 0.789
0.046 0.047 0.051 0.046
8 yr 0.840 0.827 0.884 0.803
0.050 0.047 0.048 0.049
9 yr 0.860 0.857 0.915 0.817
0.055 0.048 0.048 0.053
10 yr 0.880 0.887 0.946 0.832
0.061 0.049 0.052 0.058
11 yr 0.900 0.917 0.977 0.846
0.067 0.051 0.057 0.064
12 yr 0.920 0.947 1.008 0.860
0.073 0.054 0.065 0.069
13 yr 0.970 0.977 1.039 0.906
0.079 0.058 0.073 0.075
14 yr 1.020 1.029 1.091 0.952
0.084 0.063 0.080 0.079
15 yr 1.070 1.081 1.143 0.998
0.089 0.070 0.087 0.083
16 yr 1.120 1.133 1.195 1.044
0.093 0.079 0.091 0.086
17 yr 1.170 1.185 1.231 1.090
0.096 0.089 0.092 0.086
18 yr 1.220 1.136
0.097 0.085
19 yr 1.220 1.136
0.097 0.082
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Male reference values for Total Body BMD and SD – Enhanced Analysis (Prodigy, iDXA)
USA/N. Europe BMDCS White BMDCS Black China/ Asia
5 yr 0.645 0.621
0.053 0.058
6 yr 0.671 0.639
0.054 0.057
7 yr 0.696 0.667 0.737 0.657
0.058 0.059 0.064 0.058
8 yr 0.721 0.705 0.776 0.674
0.063 0.059 0.061 0.062
9 yr 0.746 0.742 0.816 0.692
0.069 0.061 0.061 0.067
10 yr 0.771 0.780 0.855 0.711
0.077 0.062 0.066 0.073
11 yr 0.797 0.818 0.894 0.729
0.085 0.064 0.072 0.081
12 yr 0.822 0.856 0.933 0.746
0.092 0.068 0.082 0.087
13 yr 0.885 0.894 0.972 0.804
0.100 0.073 0.092 0.095
14 yr 0.948 0.959 1.038 0.862
0.106 0.079 0.101 0.100
15 yr 1.011 1.025 1.103 0.920
0.112 0.088 0.110 0.105
16 yr 1.074 1.091 1.169 0.978
0.117 0.100 0.115 0.108
17 yr 1.137 1.156 1.214 1.036
0.121 0.112 0.116 0.108
18 yr 1.200 1.094
0.122 0.107
19 yr 1.200 1.094
0.122 0.103
Male reference values for Total Body Less Head BMD and SD – Basic Analysis (Prodigy, DPX-NT)
USA/N. Europe China/ Asia
5 yr 0.600 0.547
0.043 0.037
6 yr 0.631 0.580
0.045 0.035
7 yr 0.662 0.613
0.048 0.036
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Male reference values for Total Body Less Head BMD and SD – Enhanced Analysis (Prodigy, iDXA)
USA/N. Europe
5 yr 0.482
0.046
6 yr 0.530
0.054
7 yr 0.578
0.068
8 yr 0.626
0.071
9 yr 0.674
0.079
10 yr 0.722
0.088
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USA/N. Europe
11 yr 0.769
0.096
12 yr 0.817
0.104
13 yr 0.865
0.113
14 yr 0.913
0.121
15 yr 0.961
0.130
16 yr 1.009
0.138
17 yr 1.038
0.143
18 yr 1.038
0.143
19 yr 1.038
0.143
Male reference values for Total Body BMC and SD – Basic Analysis (Prodigy, DPX-NT)
BMDCS White BMDCS Black
5 yr
6 yr
7 yr 849 929
136 126
8 yr 974 1083
125 118
9 yr 1099 1237
131 138
10 yr 1224 1391
152 178
11 yr 1349 1545
184 233
12 yr 1474 1699
225 295
13 yr 1793 2035
273 358
14 yr 2112 2371
325 414
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Growth Indices
Pediatric growth reference values are available for the following relationships:
● height for age
● bone area for height
● BMC for bone area
● BMC for lean mass
● lean mass for height
The height for age reference values come from regression fits to the LMS
parameters used to create the Center for Disease Control’s year 2000 growth charts
[http://www.gov/growthcharts], which were mostly constructed using National Health
and Nutrition Examination Survey (NHANES) data. The specifications described in this
section apply to the following Reference Population selections: USA (Lunar), Australia
(Lunar), Germany, Brazil, England, Australia (Combined Geelong/Lunar), Finland, Italy,
Spain and USA (Combined NHANES/Lunar).
Reference values for bone area for height, BMC for bone area, BMC for lean mass, and
lean mass for height are based on DXA total body measurements from over 1000
female and over 600 male pediatric subjects ages 5 through 19 made at 8 locations in
the USA, Europe, and Australia. These indices have been shown previously to be useful
in pediatric bone assessment.10 -12 Data were fit to LMS models which describe the
population distribution at each value of the independent variable in terms of three
parameters: L (the Box-Cox power parameter λ) which specifies the skew, M which
specifies the median (= mean of the transformed distribution), and S which specifies
the standard deviation. Initial parameter fits used the penalized likelihood method
of Cole and Green13. The L parameter was then used to transform the data and
equations describing both M and (using Altman’s method13) S were iteratively fit by
regression. Limits were set so that reference values would not be applied to patients
who fall outside of the range of the subjects measured. Tables of selected centiles
of the reference values follow.
Basic Analysis
Basic Analysis is available on Prodigy and DPX-NT.
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Female Pediatric Total Body Bone Area for Height Centiles – Basic Analysis
Bone Area (cm²) for Centile
Height 1 5 20 50 80 95 99
(cm)
90 427.1 452.9 485.3 521.8 561.0 601.1 637.4
95 476.2 505.0 541.1 581.7 625.5 670.2 710.7
100 529.4 561.4 601.6 646.8 695.4 745.1 790.2
105 587.1 622.5 667.1 717.2 771.1 826.3 876.2
110 649.4 688.6 737.9 793.4 853.0 914.0 969.2
115 716.7 760.0 814.4 875.6 941.4 1008.8 1069.7
120 789.3 837.0 896.9 964.3 1036.8 1111.0 1178.1
125 867.6 920.0 985.9 1059.9 1139.6 1221.1 1294.9
130 951.8 1009.3 1081.6 1162.9 1250.2 1339.7 1420.6
135 1042.4 1105.4 1184.5 1273.5 1369.2 1467.2 1555.8
140 1139.7 1208.6 1295.1 1392.4 1497.0 1604.1 1701.0
145 1244.1 1319.3 1413.7 1519.9 1634.1 1751.1 1856.8
150 1356.0 1438.0 1540.9 1656.7 1781.1 1908.6 2023.9
155 1475.9 1565.1 1677.1 1803.1 1938.6 2077.4 2202.9
160 1604.3 1701.2 1823.0 1959.9 2107.1 2258.0 2394.4
165 1741.5 1846.7 1978.9 2127.6 2287.4 2451.1 2599.2
170 1888.1 2002.2 2145.5 2306.7 2480.0 2657.5 2818.1
175 2044.7 2168.2 2323.4 2498.0 2685.6 2877.9 3051.7
Male Pediatric Total Body Bone Area for Height Centiles – Basic Analysis
Bone Area (cm²) for Centile
Height 1 5 20 50 80 95 99
(cm)
80 334.3 352.5 375.1 400.5 427.5 455.0 479.7
85 380.5 401.2 427.0 455.8 486.6 517.9 546.1
90 430.4 453.8 483.0 515.6 550.4 585.8 617.7
95 484.1 510.4 543.2 579.9 619.1 658.9 694.7
100 541.7 571.1 607.9 648.9 692.8 737.3 777.4
105 603.4 636.2 677.1 722.8 771.6 821.3 865.9
110 669.2 705.6 751.0 801.7 855.8 910.9 960.4
115 739.4 779.6 829.8 885.8 945.6 1006.4 1061.1
120 814.1 858.3 913.6 975.2 1041.1 1108.1 1168.3
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Female Pediatric Total Body BMC for Bone Area Centiles – Basic Analysis
BMC (g) for Centile
Bone Area 1 5 20 50 80 95 99
(cm²)
500 327.6 338.3 351.2 365.0 379.1 392.9 404.8
650 433.3 448.0 465.8 484.9 504.5 523.6 540.1
800 548.9 568.4 591.9 617.2 643.0 668.3 690.3
950 674.5 699.4 729.5 761.8 794.9 827.4 855.5
1100 809.9 840.9 878.4 918.8 960.3 1000.8 1036.1
1250 954.9 992.9 1038.8 1088.3 1139.2 1189.0 1232.3
1400 1109.6 1155.4 1210.7 1270.4 1331.7 1392.0 1444.3
1550 1273.8 1328.2 1394.0 1465.0 1538.1 1609.9 1672.4
1700 1447.4 1511.3 1588.7 1672.3 1758.4 1843.1 1916.8
1850 1630.4 1704.7 1794.8 1892.2 1992.8 2091.7 2177.8
2000 1822.5 1908.2 2012.3 2125.0 2241.3 2355.8 2455.7
2150 2023.8 2122.0 2241.3 2370.5 2504.1 2635.7 2750.6
2300 2234.2 2345.9 2481.7 2629.0 2781.4 2931.6 3062.9
2450 2453.5 2579.8 2733.5 2900.4 3073.2 3243.7 3392.8
2600 2681.8 2823.8 2996.8 3184.8 3379.7 3572.2 3740.6
2750 2918.8 3077.7 3271.6 3482.3 3701.0 3917.3 4106.6
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Male Pediatric Total Body BMC for Bone Area Centiles – Basic Analysis
BMC (g) for Centile
Bone Area 1 5 20 50 80 95 99
(cm²)
500 329.7 341.3 355.3 370.2 385.6 400.6 413.6
650 433.4 449.0 467.9 488.1 508.9 529.2 546.8
800 546.5 566.7 591.1 617.3 644.2 670.5 693.4
950 669.1 694.4 725.0 757.9 791.7 824.8 853.5
1100 801.0 832.1 869.6 910.0 951.6 992.3 1027.6
1250 941.9 979.5 1024.8 1073.7 1123.9 1173.1 1215.9
1400 1091.5 1136.3 1190.5 1248.9 1309.0 1367.9 1419.2
1550 1248.9 1302.0 1366.3 1435.7 1507.1 1577.3 1638.3
1700 1413.5 1476.2 1552.1 1634.1 1718.7 1801.8 1874.2
1850 1584.9 1658.4 1747.7 1844.3 1944.0 2042.1 2127.6
2000 1762.7 1848.6 1953.1 2066.2 2183.2 2298.4 2399.0
2150 1947.3 2046.9 2168.2 2299.9 2436.2 2570.7 2688.3
2300 2138.8 2253.5 2393.4 2545.4 2703.1 2858.9 2995.3
2450 2337.4 2468.5 2628.6 2802.9 2983.9 3163.0 3320.0
2600 2543.3 2692.1 2874.0 3072.3 3278.6 3483.1 3662.4
2750 2756.2 2924.0 3129.4 3353.7 3587.4 3819.3 4022.9
2900 2976.2 3164.3 3395.0 3647.2 3910.4 4171.9 4401.7
3000 3126.6 3329.1 3577.6 3849.6 4133.7 4416.2 4664.7
Female Pediatric Total Body Lean Tissue Mass for Height Centiles – Basic Analysis
Lean Tissue Mass (g) for Centile
Height (cm) 1 5 20 50 80 95 99
80 6830 7264 7826 8483 9220 10009 10755
90 8166 8685 9357 10143 11024 11968 12860
100 9737 10356 11157 12094 13144 14270 15333
110 11593 12329 13284 14399 15650 16990 18256
120 13798 14674 15810 17138 18626 20221 21728
130 16433 17477 18830 20410 22183 24082 25877
140 19602 20847 22461 24347 26461 28727 30868
150 23441 24930 26860 29114 31643 34352 36913
160 28127 29913 32229 34934 37968 41219 44291
170 33896 36048 38839 42099 45755 49673 53376
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Male Pediatric Total Body Lean Tissue Mass for Height Centiles – Basic Analysis
Lean Tissue Mass (g) for Centile
Height 1 5 20 50 80 95 99
(cm)
80 7064 7540 8162 8892 9717 10608 11457
90 8462 9033 9777 10652 11640 12708 13724
100 10110 10791 11680 12725 13906 15182 16396
110 12062 12875 13936 15183 16592 18113 19562
120 14388 15358 16623 18111 19791 21606 23334
130 17177 18335 19845 21621 23628 25795 27858
140 20544 21929 23735 25859 28259 30850 33317
150 24637 26298 28464 31011 33889 36997 39956
160 29654 31653 34260 37326 40790 44531 48092
170 35860 38277 41430 45137 49326 53850 58157
180 43614 46554 50388 54897 59992 65494 70732
190 53413 57014 61709 67231 73471 80209 86623
Female Pediatric Total Body BMC for Lean Tissue Mass Centiles – Basic Analysis
BMC (g) for Centile
Lean Mass 1 5 20 50 80 95 99
(g)
6500 149.1 162.4 179.6 199.6 221.9 245.4 267.3
8200 209.9 228.6 252.8 281.0 312.3 345.4 376.2
10000 279.5 304.4 336.7 374.2 415.8 459.9 500.9
20000 732.2 797.5 882.1 980.2 1089.4 1204.8 1312.3
30000 1254.8 1366.7 1511.5 1679.8 1866.8 2064.6 2248.8
40000 1820.1 1982.5 2192.6 2436.7 2707.9 2994.9 3262.1
50000 2415.5 2631.0 2909.8 3233.7 3593.7 3974.5 4329.1
Male Pediatric Total Body BMC for Lean Tissue Mass Centiles – Basic Analysis
BMC (g) for Centile
Lean Mass 1 5 20 50 80 95 99
(g)
8200 207.4 223.1 243.0 265.8 290.7 316.6 340.5
10000 278.9 299.9 326.7 357.3 390.8 425.7 457.8
20000 714.5 768.3 836.9 915.4 1001.2 1090.7 1172.8
30000 1168.3 1256.2 1368.4 1496.7 1637.1 1783.3 1917.5
40000 1618.6 1740.4 1895.8 2073.6 2268.1 2470.6 2656.6
50000 2059.5 2214.6 2412.4 2638.6 2886.0 3143.7 3380.4
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Enhanced Analysis
Enhanced Analysis is available on iDXA and Prodigy.
Female Pediatric Total Body Bone Area for Height Centiles – Enhanced Analysis
Bone Area (cm²) for Centile
Height (cm) 1 5 20 50 80 95 99
100 768.0 793.8 824.9 858.0 891.8 924.6 953.0
105 841.7 870.0 904.0 940.3 977.4 1013.4 1044.4
110 916.9 947.8 984.8 1024.4 1064.7 1104.0 1137.8
115 993.6 1027.0 1067.1 1110.0 1153.7 1196.2 1232.9
120 1071.6 1107.6 1150.9 1197.1 1244.3 1290.1 1329.7
150 1563.2 1615.8 1679.0 1746.4 1815.2 1882.1 1939.8
190 2267.9 2344.2 2435.8 2533.7 2633.5 2730.5 2814.2
Male Pediatric Total Body Bone Area for Height Centiles – Enhanced Analysis
Bone Area (cm²) for Centile
Height 1 5 20 50 80 95 99
(cm)
100 759.5 784.0 815.1 850.5 889.0 929.2 966.3
105 831.3 858.3 892.3 931.0 973.2 1017.2 1057.8
110 905.7 935.0 972.1 1014.2 1060.2 1108.1 1152.3
115 982.3 1014.1 1054.3 1100.0 1149.9 1201.9 1249.8
120 1061.1 1095.5 1138.9 1188.3 1242.2 1298.3 1350.1
150 1572.5 1623.4 1687.8 1760.9 1840.8 1924.0 2000.7
190 2322.4 2397.5 2492.6 2600.7 2718.6 2841.5 2954.9
Female Pediatric Total Body BMC for Bone Area Centiles – Enhanced Analysis
BMC (g) for Centile
Bone Area 1 5 20 50 80 95 99
(cm²)
850 492.4 508.3 527.7 548.8 570.8 592.6 611.7
860 497.8 514.0 533.9 555.5 578.1 600.4 620.0
880 508.8 525.8 546.6 569.2 592.9 616.3 636.9
900 520.0 537.8 559.5 583.3 608.0 632.6 654.3
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Male Pediatric Total Body BMC for Bone Area Centiles – Enhanced Analysis
BMC (g) for Centile
Bone Area 1 5 20 50 80 95 99
(cm²)
850 508.4 526.8 549.3 573.9 599.6 625.2 647.8
860 513.6 532.3 555.2 580.3 606.5 632.6 655.6
880 524.1 543.5 567.2 593.3 620.5 647.6 671.6
900 534.8 554.9 579.5 606.5 634.8 663.0 687.9
1000 591.6 615.5 645.0 677.4 711.4 745.4 775.6
1500 979.8 1033.8 1101.3 1176.8 1257.4 1339.5 1413.4
2200 1851.0 1994.3 2177.6 2387.7 2618.0 2858.6 3079.9
Female Pediatric Total Body Lean Tissue Mass for Height Centiles – Enhanced
Analysis
Lean Tissue Mass (g) for Centile
Height (cm) 1 5 20 50 80 95 99
100 8766 9101 9522 9995 10504 11027 11502
105 9648 10052 10562 11139 11764 12412 13004
110 10602 11084 11695 12392 13152 13946 14676
115 11633 12203 12930 13764 14682 15646 16541
120 12749 13418 14278 15270 16369 17533 18620
150 21797 23392 25507 28046 30984 34240 37423
190 45233 49727 55939 63785 73406 84771 96620
Male Pediatric Total Body Lean Tissue Mass for Height Centiles – Enhanced Analysis
Lean Tissue Mass (g) for Centile
Height 1 5 20 50 80 95 99
(cm)
100 9198 9630 10180 10807 11494 12214 12878
105 10132 10635 11277 12014 12826 13681 14474
110 11139 11722 12469 13331 14285 15295 16239
115 12228 12899 13764 14768 15885 17073 18190
120 13405 14176 15174 16337 17639 19032 20348
150 22877 24548 26762 29421 32496 35904 39234
190 46735 51076 57018 64428 73383 83792 94463
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BMC (g) for Centile
Lean 1 5 20 50 80 95 99
Mass(g)
9000 392.9 417.1 447.6 482.0 519.0 556.9 591.3
10000 439.6 466.7 500.8 539.3 580.7 623.1 661.6
15000 677.3 719.1 771.6 830.8 894.6 960.0 1019.2
20000 920.3 977.1 1048.6 1129.0 1215.7 1304.6 1385.0
25000 1167.5 1239.5 1330.2 1432.2 1542.1 1654.9 1757.0
35000 1714.9 1816.0 1942.8 2085.2 2238.0 2394.3 2535.4
45000 1996.1 2113.7 2261.3 2427.1 2605.0 2786.9 2951.1
Male Pediatric Total Body BMC for Lean Tissue Mass Centiles – Enhanced Analysis
BMC (g) for Centile
Lean Mass 1 5 20 50 80 95 99
(g)
9000 376.2 398.0 425.4 456.2 489.2 522.9 553.3
10000 419.8 444.2 474.8 509.2 546.0 583.6 617.5
15000 640.7 677.9 724.6 777.0 833.1 890.5 942.3
20000 864.7 915.0 978.0 1048.7 1124.5 1201.9 1271.8
25000 1091.2 1154.6 1234.1 1323.3 1419.0 1516.7 1604.9
35000 1528.0 1616.8 1728.1 1853.0 1987.0 2123.8 2247.3
45000 1930.2 2042.5 2183.1 2340.9 2510.1 2683.0 2839.0
References
1. Lu PW, Briody JN, Ogle GD, Morley K, Humphries IRG, Allen J, Howman-Giles R,
Sillence D, Cowell CT (1994) Bone mineral density of total body, spine, and femoral
neck in children and young adults: A cross-sectional and longitudinal study. J
Bone Miner Res 9:1451-1458.
2. Del Rio L, Carrascosa A, Pons F, Businve M, Yeste D, Monenech FM (1994) Bone
mineral density of the lumbar spine in white Mediterranean Spanish children and
adolescents. Changes related to age, sex, and puberty. Ped Res 35:362-366.
3. Kroger H, Kotaniemi A, Vainio P, Alhava E (1992) Bone densitometry of the spine
and femur in children by dual-energy x-ray absorptiometry. Bone Miner 17:75085.
4. Matkovic V, Jelic T, Wardlaw GM, Ilich JZ, Goel PK, Wright JK, Andon MB, Smith
KT, Heaney RP (1994) Timing of peak bone mass in Caucasian females and its
implication for the prevention of osteoporosis. J Clin Invest 93:799-808.
5. Maynard LM, Guo SS, Chumlea WC, Roche AF, Wisemandle WA, Zeller CM, Towne
B, Siervogel RM (1998) Total-body and regional bone mineral content and areal
bone mineral density in children aged 8-18 y: the Fels Longitudinal Study. Am J
Clin Nutr 68:1111-1117.
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6. Ponder SW, McCormick DP, Fawcett HD, Palmer JL, McKernan MG, Brouhard BH
(1990) Spinal bone mineral density in children aged 5.00 through 11.99 years.
ADJC 144:1346-1348.
7. Van der Sluis IM, de Ridder MAJ, Boot AM, Krenning EP, de Muinck Keizer-Schramer
SMP (2002) Reference data for bone density and body composition measured
with dual energy x-ray absorptiometry in white children and young adults. Arch
Dis Child 87:341-347.
8. Kalkwarf HJ, Zemel BS, Gilsanz V, Lappe JM, Horlick M, Oberfield S, Mahboubi S,
Fan B, Frecerick MM, Winer K, Shepherd JA (2007) The Bone Mineral Density in
Childhood Study: bone mineral content and density according to age, sex, and
race. J Clin Endocrinol Metabol 92(6):2087-2099.
9. Xu H, Chen J-X, Zhong T-M, Wu Q-L, Yuan Z-M, Wang J-F (2007) Normal
reference data for bone density in healthy Chinese children. J Clin Densitometry
10(3):266-275.
10. Molgaard C, Thomsen B-L, Prentice A, Cole TJ, Michaelsen KF (1997) Whole body
bone mineral content in healthy children and adolescents. Arch Dis Child 76:9-15.
11. Crabtree NJ, Kibirige MS, Fordham JN, Banks LM, Muntoni F, Chinn D, Boivin CM,
Shaw NJ (2004) The relationship between lean body mass and bone mineral
content in paediatric health and disease. Bone 35:965-972.
12. Hogler W, Briody J, Woodhead HJ, Cowell CT (2003) Importance of lean mass in
the interpretation of total body densitometry in childhood and adolescents. J
Pediatr 143:81-88.
13. Cole; TJ, Green M (1992) Smoothing reference centile curves: The LMS method and
penalized likelihood. Statistics in Medicine 11:1305-1319.
14. Altman DG (1993) Construction of age-related reference centiles using absolute
residuals. Statistics in Medicine 12:917-924. John Wiley & Sons, Ltd.
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E
Introduction
Body composition measurement with dual energy X-ray absorptiometry (DXA) is used
increasingly for a variety of clinical and research applications. Nutrition, exercise, and
aging have profound effects on fat and lean tissue. Body composition measurements
in general are used for a variety of health and human performance applications.
Body composition measurements provide important information for management of
patients with many conditions, including anorexia nervosa [1-8], and diseases that
cause muscle wasting, such as HIV infection (AIDS) [9-11]. Total body scans with DXA
rely on assumptions that the human body consists of bone mineral content, fat mass
and bone free lean mass. Measurements with DXA are:
● Fast, less than 10 minutes;
● Simple and non-invasive, ensuring patient cooperation;
● Low dose, equivalent to several hours of background radiation, and;
● They provide both total body and regional (trunk, arms, legs) results.
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Japan/Korea
Data were obtained from literature (1006 subjects total). [29]
Average results by decade from age 20-79 years were fitted to a third order
polynomial.
Results:
The equation for age-matched mean %Fat:
% Fat = 37.78829 +(-1.0185 x Age) + (0.02728 x Age2) + (-0.000202 x Age3)
The standard deviation of the reference population was set at 7%.
This data supports Asian patients only.
China/Asia
Data were obtained from several sources (1010 subjects total):
● 268 subjects (Beijing)
● 742 subjects (Guangzhou)
Data were pooled and average results by decade from age 20-75 years were fitted
to a function of log age.
Results:
The equation for age-matched mean %Fat:
%Fat = 11.22 + 6.124*ln(age).
The standard deviation of the reference population was set at 5.3%.
This data supports Asian patients only.
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China/Asia
Data were obtained from several sources (138 subjects total):
● 138 subjects (Guangzhou)
Data were pooled and average results by decade from age 20-83 years were fitted
to a function of log age.
Results:
The equation for age-matched mean %Fat:
%Fat = -7.708 + 7.756*ln(age).
The standard deviation of the reference population was set at 4.6%.
This data supports Asian patients only.
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Age-Matched mean %Fat vs. Age for males and females – USA/N. Europe
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References
1. Kooh SW, Noriega E, Leslie K, Muller C, Harrision JE (1996) Bone mass and soft tissue
composition in adolescents with anorexia nervosa. Bone 19:181-188.
2. Polito A, Cuzzolaro M, Raguzzini A, Censi L, Ferro-Luzzi A (1998) Body composition
changes in anorexia nervosa. Eur J Clin Nutr 52:655-662.
3. Joyce JM, Warren DL, Humphries LL, Smith AJ, Coon JS (1990) Osteoporosis in
women with eating disorders: comparison of physical parameters, exercise, and
menstrual status with SPA and DPA evaluation. J Nucl Med 31:325-331.
4. Carmichael KA, Carmichael DH (1995) Bone metabolism and osteopenia in eating
disorders. Medicine 74:254-267.
5. Grinspoon S, Miller K, Coyle C, Krempin J, Armstrong C, Pitts S, Herzog D, Klibanski A
(1999) Severity of osteopenia in estrogen-deficient women with anorexia nervosa and
hypothalamic amenorrhea. J Clin Endocrinol Metab 84:2049-2055.
6. Lucas AR, Melton III LJ, Crowson CS, O’Fallon WM (1999) Long-term fracture risk
among women with anorexia nervosa: a population-based cohort. Mayo Clin Proc
74:972-977.
7. Soyka LA, Grinspoon S, Levitsky LL, Hergog DB, Klibanski A (1999) The effects of
anorexia nervosa on bone metabolism in female adolescents. J Clin Endocrinol
Metab84: 4489-4496.
8. Haymond MW, Sundhag AL, Ellis KJ (1999) Body composition as a clinical endpoint
in the treatment of growth hormone deficiency. Horm Res 51(Suppl 3):132-144.
9. Shih R, Wang Z, Heo M, Wang W, Heymsfield SB (2000) Lower limb skeletal muscle
mass: development of dual-energy X-ray absorptiometry prediction model. J Appl
Physiol 89:1380-1386.
10. Suttmann U, Ockenga J, Selberg O, Hoogestraat L, Deicher H, Muller MJ
(1995) Incidence and prognostic value of malnutrition and wasting in human
immunodeficiency virus-infected outpatients. J Acquir Immune Defic Syndr Hum
Retrovirol 8:239-246.
11. Grinspoon S, Corcoran C, Miller K, Biller BMK, Askari H, Wang E, Jubbard J,
Anderson EJ, Basgoz N, Heller HM, Klibanski A (1997) Body composition and endocrine
function in women with acquired immunodeficiency syndrome wasting. J Clin
Endocrinol Metab 82:1332-1337.
12. Monarch Foundation, Cincinnati, Ohio. Personal communication.
13. Grinspoon S, Corcoran C, Askair H, Schoenfeld D, Wolf L, Burrows B, Walsh M,
Hayden D, Pearlman K, Anderson E, Bagoz N, Klibanski A (1998) Effects of androgen
administration in men with the AIDS wasting syndrome. Ann Intern Med 129:18-26.
14. Baumgartner RN, Stauber PM, McHugh D, Koehler KM, Garry PJ (1995)
Cross-sectional age differences in body composition in persons 60+ years of age. J
Gerontol 50A:M307-M316.
15. Karlsson MK, Gardsell P, Johnell O, Nilsson BE, Akesson K, Obrant KJ (1993) Bone
mineral normative data in Malmo, Sweden. Acta Orthop Scand 64:168-172.
16. Mautalen C, Bagur A, Vega E, Gonzalez D (1996) Body composition in normal and
osteoporotic women. Medicina 56:29-34.
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F
Reference Data
Introduction
enCORE reference data includes an option based on the National Health and Nutrition
Examination Survey (NHANES) which supports adult and pediatric comparisons for
total body bone and body composition results.
Since 1999, the National Center for Health Statistics of the Centers for Disease
Control and Prevention conducts an annual survey in the United States called
The National Health and Nutrition Examination Survey (NHANES). The NHANES
survey data is released on public use data files in two-year increments (e.g.,
NHANES 1999-2000, NHANES 2001-2002, NHANES 2003-2004, etc.). It consists of a
cross-sectional interview, examination, and laboratory data collected from a complex
multistage, stratified, clustered probability sample representative of the civilian,
non-institutionalized population with oversampling of persons over 60 years and
older, African American, and Hispanics. In 2008, six years of survey data (from 1999
through 2004) consisting of total body DXA body composition measurements results
was released (NHANES 1999-2004) (http://www.cdc.gov/nchs/nhanes/dxx/dxa.htm).
In total, the NHANES 1999-2004 survey data included total body DXA scans on a
sample of 22,000 Americans from 8 to over 85 years of age. This survey data was
collected on Hologic bone densitometers.
To provide NHANES reference data in units useful to users of GE Healthcare systems,
Hologic/GE (Lunar) cross-calibration equations were developed by the University of
California San Francisco (UCSF) for the following parameters: Total Body BMD, Total
Body BMC, Total Body Area, Total Body %Fat, Total Body Lean Mass (Soft Tissue), Total
Body Fat Mass, Appendicular Lean Mass (Soft Tissue), Trunk %Fat, Legs %Fat, Trunk
Fat Mass, Legs Fat Mass, Subtotal Body (Less Head) BMD, Subtotal (Less Head) BMC.
Z-scores and centiles can be used to compare a measurement to a reference value.
The Z-score is the number of standard deviations away from the average value of the
reference population. The centile is the percent of people in the reference population
who have a lower value. A person who is average has a Z-score of zero and is at
the 50th centile
The LMS statistical method was used to construct reference curves for dependent
variables versus independent variables [Cole and Green]. Sex and ethnicity specific
curves were constructed for each measurement dependent variables. The LMS
technique estimates three parameters: median (M), coefficient of variation (S), and
power in the Box-Cox transformation (L). These three parameters vary as a function of
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independent variables. Once these parameters were estimated, then centile curves
were constructed using the formulas:
Formula 1a: centile = M (1 + L·S·Z)^(1/L) (L≠0)
Formula 1b: centile = M·exp (1 + S·Z) (L=0)
where Z is the Z-score that corresponds to a given percentile. The LMS parameters
calculated from the independent variable are entered into the equation to calculate
the dependent value for that percentile. A Z-score for an individual DXA measurement
is calculated using the L, M and S parameters. The formula used to obtain the Z-score
for an individual is:
Formula 2a: Z = [(X/M)^L) – 1] / L·S (L≠0)
Formula 2b: Z = ln(X/M) / S (L=0)
where X is the physical measurement (e.g. whole body BMD).
The LMS values were fit using lmsChartMaker Version 2.52, Worm plots were used to
assess goodness of fit [Pan and Cole. 2004].
Generation of equations to describe the LMS tables was performed using TableCurve
2D version 5.01.01 software (Systat Software, Inc., Chicago, IL). Regression equations
fitting the table L, M and S parameters were selected from a list of approximating
functions. The selected functions maximized the coefficient of determination subject
to constraints. The enCORE software uses the equations for interpolation and limited
extrapolation of the LMS parameters over defined ranges of the covariates.
For users of GE Healthcare DXA densitometers, Lunar/NHANES reference tables
were generated for the following relationships (sex=male, female; ethnicities=white,
black, Mexican American), and age groups (Children=8 to 19 years old, Adults=20 to
85 years old).
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Notes:
1. Because of upper limits on weight and height of subjects being scanned,
NHANES imputed the subjects’ DXA results for those subjects over the weight
and height limit of the Hologic scanner. To accurately generate the centiles for
the DXA measures, subjects over 136 kg (300 lbs) were excluded from the final
Lunar/NHANES reference data.
2. Reference values are generated for region %Fat (not tissue %Fat).
3. If Hispanic ethnicity is selected, reference values will be based on
Mexican-American NHANES study subjects.
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4. The NHANES total body adult reference data, collected from a representative
sample of the American population from 1999 through 2004, is different from
the USA (Lunar) reference data which included U.S. and Northern European
populations collected using stricter exclusion criteria. The NHANES total body
pediatric BMD reference data, collected from a representative sample of American
children from 1999 through 2004, is different from the USA (Lunar) and BMDCS
pediatric reference data, collected using stricter exclusion criteria.
5. For Adult total body BMD measurements, there are no T-scores generated when
using NHANES 1999-2004. An age-matched comparison is the preferred method
when using NHANES 1999-2004 reference population given its broad inclusion
criteria.
References:
1. UCSF FINAL STUDY REPORT: Standardization of Total Body Bone Density and Body
Composition between Hologic and GE Lunar, Investigators: J. A. Shepherd, Ph.D.,
Bo Fan, MD, X.P.Wu, MD, M.A.Levine, MD
2. Cole, T. J. and P. J. Green (1992). "Smoothing reference centile curves: the LMS
method and penalized likelihood." Stat Med11(10): 1305-19.
3. Pan, H. and T. J. Cole (2004). "A comparison of goodness of fit tests for age-related
reference ranges." Stat Med 23(11): 1749-65.
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USA (NHANES 1999-2004) Total Body Reference Data
430 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
431 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
432 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
433 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
434 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
435 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
436 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
437 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
438 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
439 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
440 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
441 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
442 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
443 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
444 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
445 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
446 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
447 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
448 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
449 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
450 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
451 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
452 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
453 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
454 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
455 X-ray Bone Densitometer with enCORE v17 software - User Manual
USA (NHANES 1999-2004) Total Body Reference Data
456 X-ray Bone Densitometer with enCORE v17 software - User Manual
AFF Phantom Study Results
G
Introduction
AFF bench testing was performed using a set of 5 anthropomorphic femur phantoms
with simulated beaks of different sizes. Simulated beaks were composed of a calcium
carbonate-based compound that mimics the expected size and density of AFF beaks
in vivo. The projected beaks on all 5 phantoms were measured on Prodigy and iDXA
and the beaking index at each beak compared to expected values measured with
digital calipers.
457 X-ray Bone Densitometer with enCORE v17 software - User Manual
AFF Phantom Study Results
The diagram below shows the femur rotation direction using the patient’s right foot.
Skewing of femur angle relative to the DXA table long axis from -5° to +5° produced
beak size variation of ±0.2mm.
458 X-ray Bone Densitometer with enCORE v17 software - User Manual
AFF Phantom Study Results
Abduction Adduction
459 X-ray Bone Densitometer with enCORE v17 software - User Manual
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