GE Healthcare Lunar enCORE-based X-ray Bone Densitometer User Manual

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GE Healthcare

Lunar

enCORE-based X-ray Bone Densitometer User Manual

Revision 5 - Part number: LU43616EN Jan-2010

GE Medical Systems LUNAR Contact Numbers

Headquarters

GE Medical Systems Lunar

3030 Ohmeda Dr. Madison, WI 53718 USA +1 (800) 437-1171

China

No. 19 Changjiang Road Wuxi, Jiangsu, 214028 P.R.C. +86-510-85225888 +86-510-85226688 (fax)

www.gehealthcare.com

DPX Series YZB/USA 2099

Prodigy Series YZB/USA 0509

iDXA YZB/USA 1104-2007

Operator's Manual for DPX-NT, DPX-MD+, DPX Bravo, DPX Duo, Prodigy, Prodigy Advance, Prodigy Primo, and Lunar iDXA x-ray bone densitometers systems using enCORE with Windows XP Professional computers. GE Healthcare recommends viewing the instructions for navigating the Lunar enCORE™ based X-ray Bone Densitometer User Manual before proceeding through the online guide for the first time. Before operating scanner, read the Safety and Technical Specifications manual which is part of operator's instructions.

SFDA(I) 20023301115

SFDA(I) 20043301375

SFDA(I) 20073302084

GE Medical Systems IT GmbH Munzinger Strasse 3-5 D-79111 Freiburg, Germany +49 212 2802 652 +49 0761 45 43 233 (fax)

France

11 Avenue Morane Saulnier 78 457 VELIZY +33-1-34-49-5365 +33-1-34-49-5406 (fax)

DPX-Bravo SFDA Register Number:

Production License Number:

Product Standard Number:

Production & Registration Address:

Service Address:

Postal Code: Contact Phone:

Germany

Beethoven Str. 239 D-42655 Solingen Germany +49-212-2802-0 +49-212-2802-390 (fax)

Asia/Pacific

4-7-127 Asahigaoka Hino-shi, Tokyo 191-8503 Japan +81-42-585-5111 +81-42-585-3077 (fax)

JSFDA(I) 2009 No.2300674 YZB/苏0637-2009 苏食药监械生产许2001-0041号 No.19 Changjiang Road, Wuxi National Hi-Tech Development Zone, Jiangsu P.R.China GE Medical Systems Trade Development Corporation (Shanghai) Co.,Ltd 3 floor, CTP1 building, No1. Huatuo Road ZhangjiangGaoke, Shanghai 201203 8008108188

Table of Contents

Introduction ................................................................................................................. 7

Intended Use ....................................................................................................... 7

Device Descriptions ............................................................................................ 7

Installation and Operation ................................................................................. 11

1.0 Screens and Toolbars ....................................................................................... 14

1.1 Overview ..................................................................................................... 14

1.2 Main Screen ............................................................................................... 15

1.3 Analyze Screen .......................................................................................... 16

1.4 Directory Screen ........................................................................................ 18

1.5 New Measurement Screen ........................................................................ 20

1.6 Quality Assurance screen .......................................................................... 23

1.7 Options ....................................................................................................... 24

2.0 Quality Assurance .............................................................................................. 34

3.0 Measurement .................................................................................................... 37

3.1 Measurement Overview & Warnings .......................................................... 37

3.2 Measurement Procedures .......................................................................... 38

3.3 Pediatrics Option ....................................................................................... 53

3.4 OneScan .................................................................................................... 53

3.5 OneVision Feature ..................................................................................... 55 

3.6 Orthopedic Hip Option ............................................................................... 56

3.7 Quick View .................................................................................................. 58

3.8 Spine Phantom Procedure .......................................................................... 58

4.0 Analysis Procedures ........................................................................................... 60

4.1 Basic analysis procedures ......................................................................... 61

4.2 AP Spine Analysis ...................................................................................... 64

4.3 APVA Morphometry Analysis ..................................................................... 66

4.4 APVA Spine Geometry Analysis ................................................................ 66

4.5 Femur/ DualFemur Analysis ....................................................................... 68

4.6 Advanced Hip Analysis ............................................................................... 69 

4.7 Total Body Analysis.................................................................................... 73

4.8 Composition Analysis ................................................................................. 75

4.9 Lateral Spine Analysis ............................................................................... 85

4.10 LVA Morphometry Analysis ....................................................................... 86

4.11 LVA Spine Geometry Analysis .................................................................. 93

4.12 Forearm Analysis ..................................................................................... 94 

4.13 Hand Analysis .......................................................................................... 96 

4.14 Orthopedic Analysis .................................................................................. 97 

4.15 Pediatric Analysis ...................................................................................... 98

4.16 Small Animal Body Analysis ................................................................... 101

4.17 Custom Reference Population ................................................................ 103

4.18 ScanCheck™ ......................................................................................... 104

4.19 Practice Management Tools .................................................................. 106

4.20 Composer Reports ................................................................................. 110

4.21 DXA Results Report ................................................................................ 114

4.22 Precision Calculator ................................................................................ 118

4.23 Custom Analysis .................................................................................... 120

4.24 FRAX* 10-Year Fracture Risk ................................................................. 122

5.0 Database Maintenance .................................................................................... 124 

5.1 Maintenance Procedures .......................................................................... 125

5.2 Compress Database ............................................................................... 125 

5.3 Delete Database ..................................................................................... 126 

5.4 Edit Database ......................................................................................... 126

5.5 New Database ....................................................................................... 127

5.6 Archive .................................................................................................... 128

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5.7 Rebuild Database................................................................................... 128

5.8 Database Importing ................................................................................... 129

5.9 Move ....................................................................................................... 131

5.10 Copy exam file ...................................................................................... 132

5.11 Change Image Type ............................................................................. 133

5.12 Delete patient and Delete image ........................................................... 133

5.13 Edit Patient and Edit Image .................................................................. 134

5.14 External USB Hard Drive ........................................................................ 134

5.15 SQL Database Interface ......................................................................... 134

5.16 Task Scheduler ....................................................................................... 137

5.17 Batch Exam File Operations ................................................................... 137

Index ....................................................................................................................... 138



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Caution: United States Federal law restricts this device to sale by or on the order of a licensed physician. This is required per 21CFR801.109 (code of federal regulations). The information in this manual is subject to change without notice. You may use or copy the software described in this manual only in accordance with the terms of your software license, product warranty, or service contract agreements. No part of this publication may be reproduced for any purpose whatsoever, stored in a retrieval system, or transmitted in any form or by any means, mechanical, photocopying, recording or otherwise, without the express written permission of GE Medical Systems Lunar. GE Medical Systems Lunar makes no warranty of any kind with regard to this material, and shall not be held liable for errors contained herein or for incidental or consequential damages in connection with the furnishings or use of this manual. Read this manual thoroughly before using the system or attempting to service any components. Unauthorized service may void system warranties or service contracts. Consult GE Medical Systems Lunar Support before attempting any service: 800-437-1171. LUNAR is a registered trademark of GE Medical Systems Lunar. All other product and brand names are registered trademarks or trademarks of their respective companies. Copyright© 1999, 2000, 2001,2002, 2003,2004,2005, 2006, 2007, 2008, 2009, 2010 GE Medical Systems Lunar, Madison, Wisconsin. All rights reserved.

Software License Agreement and Limited Software Warranty

Please carefully read the following terms and conditions before installing or operating the GE Medical Systems Lunar Software ("Software"). By installing or using the Software in your GE Medical Systems Lunar product, You indicate your acceptance of these terms and conditions. If You do not agree with the terms and conditions, do not install or operate the Software and return it to GE Medical Systems Lunar. The Software has been provided to You for use on a specific GE Medical Systems Lunar product. The Software is provided under the terms of this Agreement and is licensed to You, not sold. Your rights to use the Software are subject to the terms and conditions contained within this License Agreement and GE Medical Systems Lunar reserves any rights not expressly granted to You. This License is non-exclusive and a non-transferable license to use the GE Medical Systems Lunar Software. Re-distribution of Software or any documentation provided to you by GE Medical Systems Lunar is strictly prohibited. This product includes some software components that are licensed under the GNU General Public License (GPL). Source code for GPL components is available upon request.

The terms and conditions of this License Agreement and Limited Software Warranty are as follows:

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 Medical Systems Lunar may update or revise the Software, and in so doing incur no obligation to furnish such updates to You under this License. GE Medical Systems Lunar 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 Medical Systems Lunar 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.

3. TERM AND TERMINATION.

This License is effective until terminated. This License will terminate immediately without notice from GE Medical Systems Lunar or judicial resolution if You fail to comply with any provision of the License. Upon any termination of this License, You agree to return or destroy the Software, all accompanying written materials and all copies thereof in any form. Section 5 will survive any termination.

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 Medical Systems Lunar 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 Medical Systems Lunar. GE Medical Systems Lunar 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 Medical Systems Lunar 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 MEDICAL

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SYSTEMS LUNAR SHALL HAVE NO RESPONSIBILITY TO REPLACE THE SOFTWARE. GE Medical Systems Lunar will consider this warranty to be void if You fail to comply with the terms in the Software License Agreement.

6. TITLE.

Title, ownership rights, and intellectual property rights in the Software shall remain with GE Medical Systems Lunar. This Software is protected by the copyright laws and treaties.

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. This product includes some software components that are licensed under the GNU General Public License (GPL). Source code for GPL components is available upon request.

General Product Information

The bone densitometer is designed to estimate the bone mineral density of patients when medically indicated by their physicians. The manuals provide instructions for operating the software and scan table, system information, and maintenance information. Variables Affecting Scan Results Scan results can be affected by operator technique and patient variability:

• Operator technique refers to patient positioning and scan analysis. To minimize technique variables, 1) establish consistent positioning and scan analysis routines by using anatomical landmarks when positioning patients, and 2) during analysis, manipulate raw scan data only when absolutely necessary.

• Patient variability refers to changes in the patient's medical history, metabolism, and diet. It also refers to diagnostic procedures that involve radionuclide uptake and medical treatment, and the presence of external radiation (particularly the use of other radiation-generating devices in the vicinity of the system). To minimize patient variability, 1) thoroughly familiarize yourself with the patient's history, and 2) install the scanner in an environment effectively shielded from other sources of external radiation.

United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician.

Operator Profile

The intended users of the DXA scanner are medical professionals with knowledge and experience required to work with x-ray equipment.

Training Information

GE Medical Systems Lunar or authorized GE Medical Systems Lunar distributors provide individual, hands-on training as part of the installation procedure for your system. (GE Medical Systems Lunar 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.

IMPORTANT: Only trained technologists should operate the system. New technologists should receive training prior to unsupervised operation of the system. Additional training sessions are available on request for a nominal fee. For more information, contact GE Medical Systems Lunar Support at 800-334-5831, or your local GE Medical Systems representative.

Cautions for DXA Determinations

You should be aware of the following factors which may affect the clinical accuracy of DXA spine estimates: marked distortions of skeletal architecture-e.g., osteophytes, degenerative disc disease, spinal arthritis, spondylolisthesis, kyphoscoliosis, and vertebral fractures-and significant calcium deposits in the aorta can falsely elevate spine bone mineral values. Regions that contain these dystrophic calcifications can be excluded from the scan analysis in some cases. The scanner can be used to monitor changes in bone mineral over time in patients with these disorders, but caution must be taken in interpretation. Use DXA estimates as an aid to other methods in the evaluation of patient bone mineral status in the clinical setting. In addition, spine estimates will be difficult to interpret for patients with orthopedic metal devices and previous surgical interventions, such as bone grafts. Radiographic contrast material and radiopharmaceuticals used for myelograms, barium enemas, and other diagnostic tests prevent accurate estimates. Barium clears the body within a few days, but the oil-based dyes used in myelograms several years ago may remain within the body for years. A three-day waiting period is sufficient time for barium and most radiopharmaceuticals to be completely discharged from the body. Femur estimates will be difficult to interpret for patients with orthopedic metal devices and previous surgical interventions. The most common complicating factors for femur estimates are prosthetic devices and surgical implants in the region of the bone scan. Results may be adversely affected if the patient has difficulty with the desired 25° inward rotation of the leg or with maintaining this position without movement. Total Body estimates require consistent patient positioning for accurate results and will be difficult to interpret for patients with orthopedic metal devices and previous surgical interventions. The operator should pay particular attention to the location of the patient's arms, keeping the positioning the same for each scan. Results may be affected if the patient moves during the scan.

Precautions for Standard Operating Procedures

• Do not attempt to operate the scanner without first reading this manual.

• Do not remove the assembly panels or attempt any repairs without prior instructions from authorized GE Medical Systems

Lunar personnel.

• Do not sit or lie on the scan table for purposes other than scanning.

• 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 Medical Systems Lunar Support. Also, call GE Medical Systems Lunar if more than two failures occur in a one-week period.

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• If the patient is or might be pregnant, always contact the patient's physician before performing a scan.

• Remain in the room with the patient while a scan is in progress.

• Restrict access to the room to authorized personnel.

• Do not attempt to service any of the system's electrical components while the scan table is turned ON. High voltage is used to

produce x-rays.

• Radiation safety information is located in the safety and technical specifications manual you received with your system.

• To stop the scanner in an emergency, press the emergency stop button on the scan arm. DO NOT use the emergency stop

button to routinely abort a scan.

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 the CD sleeve. Put the CD in the CD-ROM drive. When the Installation window appears, select the product software option. Follow the screen prompts to install the program. The software will attempt to install validated Microsoft Security updates on all U.S. computers before installing the product software. This may take up to 45 minutes. The Help disk (second disk) contains Help Topic documents in PDF format for printing. You will need Adobe Acrobat Reader to open PDF documents.

Note: If the CD does not automatically start, select the My Computer icon on the desktop, select the CD-ROM drive, and select the software installation icon.

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Introduction

Intended Use

The X-ray Bone Densitometer (DPX-Bravo, DPX-Duo, DPX-NT, Prodigy, iDXA) supports the following intended use:

Provides an estimate of bone mineral density at various anatomical sites (Spine, Femur, Total Body, and Forearm). These values can then be compared to an Adult reference population at the sole discretion of the physician.

Provides an assessment of relative fracture risk based on the patient's T-score value using the categories of fracture risk defined by the World Health Organization (WHO).

Provides an assessment of 10-year fracture risk using WHO FRAX model. 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 Hip Software estimates Periprosthetic BMD of an orthopedic hip implant Optional Pediatric software option expands the range of bone densitometry reference data to include ages 5

through 19 years of age. 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 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 health care 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.

Optional Advanced Hip Assessment 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 val ues used to evaluate the structural properties of the hip.

The DPX-Duo model has special mechanical features including stirrups, storage dra wers, 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.

Device Descriptions

Structure

The X-Ray Bone Densitometer is made up of a scan arm, X-ray source assembly, and exam table. Each model is described in more detail below. The scan arm control panels for each model are described in scan arm control panel section.

Product Model

DPX Bravo and Duo

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The DPX Bravo and Duo models use pencil beam technology with a single-crystal detector and have a compact table design to provide space efficiency (see images below). The DPX Duo and the DPX Bravo come equipped with a scan arm that swings to the side of the table when not in use when not in use as a densitometer and to facilitate patient loading. X-ray scanning is not possible until the scan arm is locked into the scan position. A handle releases the scan arm interlock and allows operator to move the scan arm for patient loading. Once the patient is loaded on the table, the operator moves the scan arm back to scanning position and the arm locks into scan position. If a scan is attempted without the scan arm locked into position, the following error will be displayed:

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).

Swing Scan Arm

Scan Arm Control Panel

Exam Paper Roll and Power Switch (head of scanner-not shown)

Table Pad

DPX-Bravo

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.

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Stirrups

Storage Drawers

Patient Step

Table Pad

Swing Scan Arm (in scanning position)

Scan Arm Control Panel

Procedure Drawer

Exam Paper Roll and Power Switch (head of table--not shown)

DPX-Duo

Product Model

DPX-Pro/NT/MD+ DPX-Pro/NT/MD+ models come in full and compact sizes and u se 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).

Scan Arm

Control Panel

Table Pad

Power Switch

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DPX-NT

Product Model

Prodigy Pro/Primo/Advance Prodigy models come in full and compact sizes and use fan beam technology with a 16-channel solid-state

detector. The power switch is located at the foot of the scanner. The table weight limit is 159 kg (350 lbs).

Scan Arm

Control Panel

Table Pad

Power Switch

Prodigy Series

Product Model

iDXA The Lunar iDXA uses fan beam technology with a 64-channel solid-state detector and 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.

Scan Arm Scan Arm Control Panel

Exam Paper Roll and Power Switch (head of scanner-

-not shown)

Table Pad

iDXA

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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 their 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.

Installation and Operation

Only individuals trained by GE Lunar should service or install the X-ray Bone Densitometer. Do not attempt to service the X-ray Bone Densitometer. Please call GE service or your GE distributor for support.

Before operating X-ray Bone Densitometer, please review the Safety and Technical Specification manual.

X-ray Bone Densitometer Table Assembly

Below “Scanner” is equal to “X-ray Bone Densitometer”

Scanner Table

The Scanner table is to support the patient during a measurement or general examination. In addition, the X ray source assembly and other electronics are contained inside the scanner table.

Scan 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. The scanner arm on the DPX Duo and Bravo models has a release and locking mechanism allowing the upper arm to swivel when the scanner is idle. The scanner arm must be in the locked position over the scanner table to perform a measurement.

Scan arm control panel Indicator Lights

Symbol Indicator Status (on)

Green (power) Power is supplied to the scanner table

Yellow (x-ray) X-ray tube assembly is supplying x-rays

Yellow (shutter) Shutter is open

Amber (laser) Laser is on

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Emergency stop button

Push the red emergency stop button to stop the scanner arm and immediately shut down x-rays in an emergency. Do not use the emergency stop button to routinely stop the scanner during normal operation.

Positioning switches

The positioning switches move the scanner arm and detector to the measurement start position (the lase r 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.

Swing arm position sensing switches (DPX Duo and Bravo models only)

The swing arm position sensing switches detect the locking status of the swing arm and the swing arm latch. The swing arm latch must be locked and the swing arm must be in the locked position over the scan table before a measurement can be performed. Release of the swing arm latch during a measurement will abort the scan and the measurement data will be lost.

Scanner Start button (iDXA model only)

Once the patient has been positioned, the scan may be initiated from the green Start Scan button instead of starting the scan from the enCORE software.

See scan arm control panel for each model below:

Indicator Lights Lever to lock/unlock Swing Arm

Positioning Switches

Emergency Stop Button

DPX Duo and Bravo

Indicator Lights

Emergency Stop Button

Positioning Switches

DPX-Pro/NT/MD+

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Indicator Lights

Emergency Stop Button Positioning Switches Start Scanner Button

iDXA Front Panel

The enCORE software is used to operate the X-ray Bone Densitometer, the following chapters describe how to use the enCORE software.

Note:

Daily Quality Assurance procedure

Complete quality assurance procedures daily. Make sure each QA procedure passes. Refer to Chapter 2 for detailed instructions. Make sure you save your printed results for future reference.

Archive image files

Archive your image files before you leave for the day. Refer to Chapter 5 for detailed instructions.

Shut down computer

At the end of the day, select Exit from the Main screen, and select Exit enCORE from the close window to close the program. Then shut down the computer. Note: Do not turn off the scanner at the end of the day for stationary systems.

Some of the functions of the enCORE are not available for all X-ray Bone Densitometer models.

Classifications

Protection against electric shock: Class I, Type B Protection against water: IPX0 Operation mode: continuous operation with intermittent loading The device can neither be used in flammable anesthetic mixture with air or non flammable anesthetic mixture with oxygen or nitrous oxide.

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1.0 Screens and Toolbars

1.1 Overview

1.2 Main Screen

1.3 Analyze Screen

1.4 Directory Screen

1.5 New Measurement Screen

1.6 Quality Assurance Screen

1.7 Options

1.1 Overview

This section describes the screens and toolbars that are shown throughout the program. Screens and toolbars give the options necessary to complete the procedures given in this online Operator's Manual.

1.1.1 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.

1.1.2 Using toolbars

The toolbars show icons that represent a "tool" which lets you complete a specific procedure. To view a short description of a tool, hold the cursor stationary over the tool's icon.

1.1.3 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.

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1.2 Main Screen

The Main screen is the first screen shown during the program. Select the options that follow to access different areas of the program:

Help (F1)– select to view additional reference information concerning the operation of the scanner.

Analyze (F3)–select to open a patient measurement for analysis.

Quality Assurance (F5)–select to access

the Quality Assurance (QA) screen.

Exit (F8)–select to exit the program from the Main screen.

Measure (F2)–select to start a patient measurement.

Directory (F4)–select to work with your patient files and complete database maintenance procedures.

Options (F6)–select to change the User Options and Connectivity Options default settings or to view the Error log.

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1.2.1 Common Toolbar

The Common Toolbar is shown on all screens.

Icon Program Description

Measure

(F2 or Ctrl+M)

Analyze

(F3 or Ctrl+A)

Directory

Analyze

Results Display

Trending

Reference Data

Image

ScanCheck™

Reports

This tab lists scanner System ID number and Feature code. User Interface Options, Exam File Options and ISCD settings.If the Automatic return to Directory option

is selected, you will return to the Directory screen instead of the main screen when you close windows. The Auxiliary Workstation option is shown if you purchased th

e Multi-User Database kit. Select this option to prevent the workstation from performing QA procedures or patient measurements. The Number of Open Exams option lets you choose how many exams can be opened for analysis at the same time.

Use this option to determine how information is sorted in the Patient and Exam/Image lists and to configure default ethnicity. You can also choose to expand exams by default. Enable/Disable analysis features for all scan types.

ation to use and the type of You can also choose the type of Small Animal calibr forearm calibration to use for BMD results. The Results Display tab lets you change the appearance of graphs; Standard, WHO

or JSBMR. You can select the information shown in the results tables, select the

composition results to show, and set the Morphometry SD cutoffs.

hs and in Use this option to select the type of information shown on trending grap trending tables, and configure the software to flag significant change. The integrated Precision Calculator Tool is also located within this option.

Use this option to select a reference population and show the reference sources on the screen and the results reports. Use of the reference population comparisons is fully at the discretion of the clinician. The program does NOT show the comparative values when shipped from GE Medical Systems LUNAR. Use this option to set the colors of ROIs, bone edges, and point typed areas of an image file during analysis, and enable optimal image magnification.

Use this option to select the ScanCheck™ checks that will be included on the ScanCheck™ tab for AP Spine, Femur, Forearm and Total Body analysis.

Select Patient ID types and Report background color. Under Dexa Report Configurations select to report on Selected Region Only, Trend Multiple Results, Invert Image, GE Healthcare Logo, Report Dialog, sBMD Footnote, Comments, Show Vertebral Height T-Scores, and Show Ethnicity. Change the Report Center Defaults- where the report will be sent, the types of reports that will be created, regions to be reported on, and the number of copies f or each page of the report. User Information Includes the site name, address, phone numbers, web site and email information.

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Morphometry Report Options are configured here.

Composer

Measure

2. Systems Tab The scanner's System ID is unique. The System ID is needed for support. The feature code is only compatible with your system ID. It enables the purchased options in your software. If you wish to try out a feature before buying it, contact your sales person for a trial feature code.

Icon Function Choices

Configure the file type to output from Composer. Use the Spelling Options to customize spell checker functions.

Use this option to change the default setting for printing QA reports. Select Automatic Printing: Daily QA to have the program print a QA report each time you complete a quality assurance procedure. Select Automatic Return to Trend Screen to automatically return to the trend screen once a QA has completed. Use this option to set the default settings used during a measurement. Save prompt at end of scan (select this option to show a message after every measurement that asks you if you want to save the measurement), Allow continue after SmartScan abort, Use Old Positioner for Lateral Measurements (Densitometry and Morphometry Only), Show Previous Scan, Allow Scanner Start Button to initiate a Measurement, LVA reverse (For LVA, scan patient facing foot of table), Default to seated patient for forearm and hand scans, Pause between Femur scans, OneScan™ (no Foam Leg Block positioner for AP Spine scans), or Pause between AP Spine and Femur Scans.

Additional Feature Codes

User Interface Options

Enter Trial and IRB feature codes. Expiration dates will display below each feature code.

Automatic return to Directory will return your display back to the Directory scan after an acquisition is complete. HIPAA Secure View hides patients in the directory view. Play Multimedia Sounds option. Auxiliary Workstation for use with MUDBA setups. The Auxiliary Workstation option is shown if you purchased the Multi-User Database kit. Select this option to prevent the workstation from performing QA procedures or patient measurements. The Number of Open Exams option lets you choose how many exams can be opened for analysis at the same time. HIPAA Secure Filename On: pat_z8gutml1w.dff HIPAA Secure Filename Off: SmithJf0m485s.dff

Compress Exam Files to conserve space for high resolution images such as iDXA scans.

Exam File Options

Encrypt Exam Files

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ISCD Official Position Acceptance

Select "Yes" to accept the settings recommended by ISCD. Review current ISCD Positions from the link in the enCORE software.

FRAX

Check box(s) for ‘Enable FRAX’ and/or 'Apply US NOF/ISCD FRAX recommendations' Review the NOF/ISCD FRAX Implementation Guide from the link in the enCORE software for details.

3. Directory Tab

Icon Function Choices

Patient Sort Options

Exam Sort Options

Patient List Columns

Directory Rules & Defaults

Sort by First name, Last name or Patient ID Ascending or Descending

Sort by Measurement, Date Measured, Date Analyzed, File Name, Archive, Import, or Status Ascending or Descending Choose Patient Third column contents: Patient ID, Facility ID, Department ID or Exam ID

When duplicate patients occur follow Duplicate Patient Match Rule. Select Default Gender, Default Ethnicity, Duplicate Patient Match Rule: Use Patient Last Name & Birthdate or Use Patient ID. Checkbox Option to Expand Exams view in the directory by Default.

Enable Exam Status/notes features. Also, set defaults, actions when sending a report, and status colors.

Directory Status

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4. Analyze Tab

Icon Function Choices to Appear in the Results

Femur Analysis Options

Total Body Analysis Options

Forearm

AHA: Hip Axis Length, Upper Neck region, Lower Neck region, Calculate Hip Strength results and Hip Geometry results

Calculate Left and Right results Calculate Total Body Less Head (TBLH) result (used for Pediatric)

Forearm Calibration: Lunar, SPA or Comac

Analysis Options

Orthopedic Analysis Options

Small

Standard Gruen zones or Extended Gruen zones

Calibration: Chemical/Ash or Lunar

Animal/Research Options

Morphometry Options

Finish Button Options

Estimated Total Body

Create ROIs on Request (Recommended) Automatically create Reference ROIs when needed Automatically create ROIs for T8-L4 when opening exam

Finish Button On/Off Operation to perform: Send Report(s) to destinations, Save Exam and Close Exam

Estimate % Body Fat from Spine/Femur scan On or Off

5. Results Display Tab

Icon Function Choices

Reference Graph Options

Densitometry Table Options

Young Adult (YA) Bars: Standard SD, WHO or JSBMR Show Y2-axis values Age-Matched (AM) Bars appearance and SD applied Young Adult (YA) in % or T-Score, Age-Matched (AM) in % or T-Score. Show BMC, Show Area, Show Diagnostic Category Icons and Show All DualFemur Regions

Composition Options

Morphometry Reference Options

BMI Options

Z-Score or Centile Results Metric or English measurement system

Reference in Z-Score or Percent Height Reduction Configuration for assigning deformity Mild, Moderate and Severe

BMI cut-off points assigned per WHO or Custom BMI On or Off

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6. Trending Tab

Icon Function Choices

Trend Graph Options

Trend Table Options

Precision Calculator

Select Line Pattern, Densitometry Trend Graph, Morphometry Trend Graph, or Composition Trend Graph settings.

Flag Significant Change On or Off. Configure how trending is to be displayed.

A complete Precision Tool to determine Least Significant Change (LSC) for scan types: AP Spine, Femur, DualFemur,

Choice of Measures to Trend On

Total Body, Forearm, Hand and Lateral Spine For Densitometry Pediatric, Densitometry Adult, Morphometry, Composition Y1 axis, Composition Y2 axis, Estimated Composition Trend, and Pediatric Growth Trend.

7. Reference Data Tab

Function Choices

Choice of Reference Population

Asia, Australia (Combined Geelong/Lunar), Australia (Geelong), Australia (Lunar), Brazil, China, Egypt, Finland, France, Germany, Indonesia, Italy, Japan, Korea, Mexico, Middle East, Philippine, Spain, Tunisia, Turkey, UK, USA (Combined BMDCS/Lunar), USA (Combined NHANES/BMDCS/Lunar), USA (Combined NHANES/Lunar), USA (Lunar)

Scan Site

AP Spine, Femur, LVA, Total Body, Forearm or Lateral Spine

Choice of Default Region for Each Scan Type

Choose the region that will be the default region for analysis for each scan type

8. Image Tab

Icon Function Choices

Image Options

On or Off for: Interpolation, Invert Image, Show bone edges, Show Artifacts, Size Image to Fit screen on Open. Display On or Off: Two Total Body images, Dual Femur Images top/bottom, Composition Image for Total Body.

Image Colors

Change image colors for ROIs, Zoom Region/Masks, Bone Edges, Point Typing, Markers and Artifacts

Image Export Options

Morphometry Wizard Options

JPG Quality set

LVA Wizard Zoom Margin set in millimeters

9. ScanCheck™ Tab

Select the ScanCheck™ items that you would like to show in the analysis screen.

ScanCheck™ On or Off

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Set ScanCheck™ view to appear first when analyzing Include ScanCheck™ indications on report.(bottom of screen)

Show AP Spine

Detect the following problems

Alert Measure Technique

Correct scan mode used?

Analysis Technique

AP Spine alignment reasonably straight? 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? Analysis region free of unusual high density bone?

Anatomy Issues

Free of unusual T-Score variation? Free of unusual curvature? AP Spine - Comments:

Show Femur Alert Detect the following problems

Measure Technique

Correct scan mode used?

Sufficient pelvis and shaft separation? Femur shaft reasonably straight? Proper femur rotation?

Analysis Technique

Optimal contrast and brightness set? ROIs properly defined?

Tissue region properly defined? Bone edges properly defined? Results consistent with previous scan?

Anatomy Issues

Analysis region free of unusual high density bone?

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Femur - Comments:

Show Total Body Alert Detect the following problems

Show Forearm Alert Detect the following problems

10. Report Tab

Icon

Measure Technique

Analysis

Correct scan mode used? Patient within scan field? Optimal contrast and brightness set?

Technique

ROIs properly defined? Patient Height Entered Correctly? Patient Weight Entered Correctly? Anatomy Issues

Analysis region free of unusual high density bone?

Total Body - Comments:

Measure Technique Analysis

Forearm alignment reasonably straight? Optimal contrast and brightness set?

Technique

ROIs properly defined?

Anatomy Issues

Tissue region properly defined? Bone edges properly defined? Analysis region free of unusual high density bone? Forearm - Comments:

Function Choices

Report Patient ID Types

Report Colors

Patient Name, Patient ID, Facility ID, Dept ID, Exam ID, Attendant, Referring Physician, Reading Physician or blank.

Change the background color of DXA Reports

DXA Report Configuration

Selected Region Only, Trend Multiple Results Only, Invert Image, Show GE Healthcare Logo, Show Report Dialog, sBMD Footnote on, Show Comments, Show Vertebral Height T-Score, Show Ethnicity

Report Center Defaults

Opens the Report Center Window for configuration. See Report Center Chapter for more information.

Report Regions

Select the regions desired for each scan type. "Selected Region" will report the region currently highlighted on screen

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Report Regions for Trending

User Information

Select the trend regions desired for each scan type.

User Information will be used as a header for all DXA reports

Morphometry Report Options

Morphometry Trend Regions: Deformities Only or All Regions Morphometry Trend Results: Average Height, Posterior Height, Middle Height, Anterior Height, P/A Ratio, M/P Ratio and A/P Ratio

11. Composer Tab

Icon Function Choices

Image Storage

JPG, PNG, or WMF

Format Chart Storage Format

JPG, PNG, or WMF

Object Storage

JPG, PNG, or WMF

Format Quality and

Resolution for JPG & PNG Spelling Options

PDF Export Security Settings

Automatic or manual configuration of Quality Automatic or manual configuration of Resolution

General options, Spelling Suggestions, Dictionary or Customized Dictionary, Advanced Settings and Performance & Accuracy settings Add password protection to PDF documents exported Set permissions for printing and editing.

Display ICD9 codes with Fractures,

ICD9 Codes On or Off

Indications and Treatments

12. QA Tab

Icon Function Choices

Default QA Copies Automatic Daily QA

Print Automatic return to

trend screen Graphical Interface

Enter number of copies On or Off

On or Off

Enable QA stability analysis

Compress Patient Database after QA

Allow QA Block scans outside of Daily QA

On or Off

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QA Means

Reset Means Activation

QA AutoMentor

Enable AutoMentor to automatically export QA report to email or Fax if QA fails

13. Measure Tab

Icon Function Choices

Save Prompt at the end of a scan Allow a continue option after SmartScan abort Show Previous Scan Allow Scanner Start Button to initiate a

Measurement Use Old Positioner for Lateral Measurements (Densitometry and Morphometry only) LVA Reverse scan arm direction. Patient head at foot of the table.

Default to seated patient for forearm and hand scans

Pause between Femur scans

OneScan (Foam Leg Block positioner not used for AP Spine scans)

Pause between AP Spine and Femur scans Adjust the speed of movement of the scan

arm: Transverse Joystick Speed &

Longitudinal Joystick Speed Download scanner firmware (service tool)

On or Off On or Off On or Off On or Off On or Off On or Off

On or Off

On or Off On or Off

Faster or Slower Initiate download

1.7.2 Connectivity Options

Connectivity options let you change report delivery, fax, email, DICOM, and HL7 default settings.

1. View Connectivity Options:

Select

(F6) from the Main

screen and select Connectivity

Options.

2. Select one of the Connectivity Options tabs that follow:

Connectivity

Description Options Report Delivery

Use this option to select the recipient of your e-mailed and faxed results reports.

Referring physician-The program sends reports to the physician listed in the

patient's Primary information.

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Select the Tools menu and select

Connectivity Options.

Fax

DICOM

HL7

Support

1.7.3 Error Log

In the event you encounter difficulties which prevent normal operation of the program, view the Error Log for a list of errors that may be causing the problem. Service will need the digital file of errors.

1. To view the Error log:

Select Options the Main screen and select Error log...

2. To export the error logs go to Tools / Send Configuration and check the options to export.

The Error log consists of two sections:

• Sessions–This section lists the dates and times that the program was being us ed and the number of errors that occurred during each session.

• Errors–This section gives a description of each error that occurred during the selected session.

Reading physician-The program sends all reports to the physician listed in this

field.

Use this option to change the default settings for the fax feature.

The Receive Incoming Faxes feature lets you receive faxes if you have a fax

modem attached to your system.

The Invert Image feature lets you invert the gray scale for images on your

faxes.

An analog phone line is required.

The Fax option is only available if you purchased the TeleDensitometry kit.

Use this option to change the default settings for the email feature. In Outlook

Express or Outlook, setup a "Personal Address Book" to interface with

enCORE.

The Add case information to Subject feature automatically includes the

patient's name, the scan type, and the name of the file you are emailing in the

Subject line of the email message. Make sure a check appears in the check

box if you want to use this feature.

The Invert Image feature allows you to invert the gray scale for images in your

emails.

The Image quality drop-down list allows you to choose the quality level for

images included in your emails. Quality affects the size of the image.

The Email option is only available if you purchased the TeleDensitometry kit.

Use this option to change the default settings for the DICOM feature. If you

change the store folder location, you will also have to change the Report Folder

Location setting in the LUNAR DICOM program.

The DICOM Worklist feature displays a list of patients who are scheduled for

DXA measurements. The list is supplied by the hospital information system.

Make sure a check appears in the Directory in Worklist Mode check box if you

want to use this feature. The DICOM option is only available if you purchased

the DICOM kit.

Use this option to change the default settings for the HL7 feature.

The Worklist Mode feature displays a list of patients who are scheduled for

DXA measurements. The list is supplied by the hospital information system.

The Reporting option can send Text and Images in HL7 format. DO NOT

change any of the HL7 default settings without authorization from your network

administrator. The HL7 option is only available if you purchased the HL7 kit.

This option lists the fax and email information for your service provider. The

program uses this information to email or fax QA reports to your service

provider if the QA procedure fails.

Select the Tools menu and select

(F6) from

Error Log.

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Troubleshoot button takes you to a help topic about the selected error. Find Errors takes you to similar

errors in the list. If you cannot correct the error condition, go to Tools / Send Configuration and check the Error log and

Configuration files options. Email the files into support. Or you can 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.

2.0 Quality Assurance

2.0.1 Daily Quality Assurance Procedure

Complete a Quality Assurance (QA) test each morning before you measure a patient. If the room temperature changes more the 5°C during the day, then perform another Daily QA. This procedure calibrates and verifies functionality, as well as, the accuracy and precision of the densitometer. The QA procedure should be performed a minimum of once a week if the scanner is not being used. Save all QA printouts.

Use the black calibration block to complete a QA test (the calibration block consists of tissue-equivalent material with three bone-simulating chambers of known bone mineral content). Leave the pad on the scanner table during the QA procedure.

1. toolbar.

3. Put the calibration block on the pad so that the laser light (1) rests in the center of the cross-hair label on the calibration block.

4. Select OK. Follow the screen prompts to complete the QA procedure.

5. If the QA test did not pass, reposition the calibration block and repeat the procedure. If the procedure fails a second time, call Lunar Support for assistance.

6. To print the QA results, select Report if the auto print option is not set. Save the QA printout.

Select Quality Assurance (F5) from the Main screen or select QA from the Common

Select Start. A message instructs the technician to position the calibration block.

Laser

Brass on bottom

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2.0.2 Quality Assurance Options

Go to Tools / User Options / QA tab.

Click here or go to the Options chapter.

2.0.3 Graphical Interface

Startup Test:

Mechanical Test:

X-ray / Detector:

Calibration: BMD values of High, Medium and Low block

Phantom: BMD, BMC, Area,

Database Validation Scanner Self-test QA Block Search Peaking

Beam Stop Transverse Distance Longitudinal Distance

Spectrum Spillover Reference Counts Detector Status

chambers Tissue values of Lean, Normal and Fat block values Trend analysis

Edge detection

Click on the Trend tool to exit out of the QA process screen.

2.0.4 QA Trend Reporting Options

Click on Settings. The settings screen provides many options for QA trend reporting components.

In the upper right panel are options for the QA Report Type.

• QA Phantom Report

• Ancillary page

• Legacy QA Report

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QA Phantom Report QA Ancillary page

Legacy QA Report

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3.0 Measurement

3.1 Measurement Overview and Warnings

3.2 Measurement Procedures

3.3 Pediatric Measurement

3.4 OneScan Feature

3.5 OneVision Feature

3.6 Orthopedic Hip Measurement

3.7 Quick View

3.8 Phantom Procedure

3.1 Measurement Overview & Warnings

Patient considerations:

Obey the patient considerations that follow before you start a patient measurement:

• Clothing restrictions: Make sure the patient removes items that can attenuate the x-ray beam, such as clothing with zippers, snaps, buckles, and buttons. Ask patients to wear a jogging suit to the exam or give them an examination gown when they arrive.

• Radionuclide and radiopaque agents: Make sure the patient has not ingested or been injected with radionuclides or radiopaque agents in the past 3–5 days. If the patient has taken tests that use such agents, postpone the measurement until all traces of the element have left the patient’s body. A 72-hour waiting period is usually long enough for most agents to leave the patient’s body. However, consult your radiation safety officer (RSO).

• Pregnancy restrictions: If it is necessary to measure a pregnant patient, the fetus could be exposed to small amounts of radiation. Postpone the measurement until the end of pregnancy if clinical management is not affected. The decision to subject a fetus to radiation exposure must be made by the referring physician, noti ng that 1) bone quality for most patients does not significantly change during pregnancy and 2) in the advanced stages of pregnancy, the fetus’ mineralized bone can interfere with measuremen ts of the mother’s spine and femur.

Measurement Warnings

WARNING: Each GE LUNAR scanner is equipped with a Class II Laser that is less than 1

milliwatt in strength. DO NOT STARE INTO THE BEAM.

WARNING: Remove Foam Leg block prior to positioning scan arm over the patient

and immediately after completing an AP Spine scan.

WARNING: Insure the patient's head, arms, knees or any body part are not in direct

path of a moving scan arm.

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3.2 Measurement Procedures

This section describes the basic steps necessary to complete a patient measurement. These steps mu st be completed in the order given. Review the steps before you start a patient measurement. Note the following, whenever you see the following symbol:

WARNING: Each GE LUNAR scanner is equipped with a Class II Laser that is

less than 1 milliwatt in strength. DO NOT STARE INTO THE BEAM.

WARNING: Remove Foam Leg block prior to positioning scan arm over

the patient and immediately after completing an AP Spine scan.

WARNING: Verify the patient's head, arms, knees or any body part are not

in direct path of a moving scan arm.

3.2.1 Step 1: Record or select patient

To complete a patient measurement, you must record information for a new patient or select a patient record from the database.

Record new patient information

1. Select

2. Record the nece ssary information in the three tabs that are shown on the 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/Directory Rules and Defaults.

• 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 as the WHO criteria will only be 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. In addition, you can also enter the patient’s insurance information. This information is not required to complete a measurement.

from the Main screen or from the Directory toolbar.

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3. Select OK when you have finished recording the patient information. The New Measurement screen is shown if you started from the Main screen; if you started from the Directory screen, highlight the patient's name and select Measure from the toolbar to go to the New Measurement screen.

Select existing patient record

Select a patient for a new measurement from either the Main screen or the Directory screen. Use the Search option to find the patient, if necessary. Main screen

a. Select Measure. The Patient Information dialog box is shown. b. Select Find. The Patient and Image lists are shown. c. Double-click on the patient in the Patient list. The Patient Information dialog box is shown. d. Make sure the patient information is correct, then select OK. The New Measurement screen is

shown. Directory screen Double-click on the patient in the Patient list, or highlight the patient and select Measure from the Common toolbar. The New Measurement screen is shown.

3.2.2 Step 2: Select measurement site

The New Measurement screen shows a skeletal image which give s the sites you can select to measure. Use the mouse to click on the site you want to measure. The site you select is highlighted in the Exam list.

Information about the measurement modes is located in the Safety Information and Technical Specifications manual you received with your system.

Now follow the measurement procedure for the site you selected.

3.2.3 AP Spine measurement

The positioning requirements for an AP Spine measurement depend on whether you have chosen to use the foam leg block positioner in the User Options Measure tab. The foam block must not be used if OneScan™ is checked for a specific measurement, but it must be used if OneScan™ is not checked for the measurement. For OneScan™ measurements, the T-Score calculation assumes the foam block is not used.

1. Foam Leg Block

• If you are using the foam leg block positioner: Help the patient onto the scanner table and position the patient as follows in the center of the scan table. 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.

• after the AP Spine scan.

Warning: Remove the foam leg block prior to positioning the scan arm and immediately

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• If you are using the foam leg block:

2. OneScan™

• OneScan™ Does not use the foam leg block positioner:

Select Position from the New Measurement toolbar. The scanner arm moves to the

approximate start

position. A graphic is shown that gives the correct patient position and

measurement start position. Use the support block to elevate the patient's legs. Make sure the patient's thighs form a 60°to 90°

angle with the table top. This step helps separate vertebrae and flatten the lower back.

Help the patient onto the scanner table and position the patient as follows in the center of the scan table. Use the centerline on the table as a reference to align the patient. The patient's arms should be crossed over the chest, away from the side of each hip.

Select Position from the New Measurementtoolbar. The scanner arm moves to the

approximate start

position. A graphic is shown that gives the correct patient position and

measurement start position. Use the centerline on the scanner table as a reference to make sure the foot brace is centered. Align

the centerline with the guide on the base of the foot brace. Internally rotate the patient's legs, and secure the patient's feet to the foot brace (GE-Lunar suggests not removing the shoes).

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3. Laser Position Use the graphic shown to 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.

Select Start from the New Measurement toolbar to start the measurement. Monitor the image to make

sure it is correct.

5. Make sure the spine is in the center of the

image, all of L4 (1) is shown, the top of L5 (2) is shown in the first 1-2 sweeps for Prodigy, 5-15 scan lines for DPX. (3) Approximately 1/2 of T12 is shown.

If the image is not correct, select Abort, reposition the laser light, and restart the measurement.

If you want to complete another measurement for the patient, select Set Up from the New Measurement toolbar. Refer to the topic New Measurement screen for additional screen functions.

If you have completed measurements for the patient, select Home to move the scanner arm to the Home position.

Select Close to exit the New Measurement screen. Refer to the topic New Measurement screen for

additional screen functions.

3.2.4 Femur/DualFemur measurement

1. Help the patient onto the scanner table and position the patient as follows: 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. The patient's arms are crossed over the chest, away from the side of each hip.

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Select Position from the New Measurement toolbar. The scanner arm moves to the approximate

position.

start

3. A graphic is shown that gives the correct patient position and measurement start position for the site you are

measuring. Use the centerline on the scanner table as a reference to make sure the foot brace is centered. Align the centerline with the guide on the base of the foot brace. Internally rotate the patient's legs, and secure the patient's feet to the foot brace (GE-Lunar suggests not removing the shoes).

4. Select the appropriate scan mode based on the thickness of the femur area. Note that the scan mode for

the femur may be different than the scan mode used for the AP Sine, based on the patient's weight distribution. Use the graphic shown to 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.

Select Start from the New Measurement toolbar. Monitor the image to make sure it is correct. The Femur image shows the greater trochanter (1), femoral neck (2), and ischium (3). A minimum of three centimeters of tissue should be shown above the greater trochanter and below the ischium.

Select Abort and reposition the laser light if the image is not correct.

DualFemur:

DualFemur lets you measure the patient's left and right femur in an automatic sequence. After the program has measured the left femur, the scan arm moves to the approximate start position for the right femur. Check the start position and, if necessary, adjust the measurement start position for the right femur.

Note: DPX-Duo and DPX-Bravo have a narrow scan region. Therefore, repositioning the patient for the contra-lateral femur may be necessary.

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Select Close to exit the New Measurement screen. Refer to the topic New Measurement screen

for additional screen functions.

3.2.5 Forearm measurement

1. Put the forearm positioner on top of the pad. The L UNAR logo should be located near the patient's fingers. The forearm positioner keeps the patient's forearm from moving during a measurement.

2. Seat the patient in a chair next to the scan table. Note: Use a chair without arms or wheels. Use the same chair for all forearm m easurements to get optimal precision.

Note: Lunar 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.

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3. The arm is place d on the positioning board with the palm down with the hand near the Lunar label (1). Tell the patient to make a loose fist.

The red line (2) shows the center of the measurement area. Center the patient's forearm along this line. 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. 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. Position the laser light at this line(4) when you start a measurement.

4. Attach the velcro straps over the fist and over the arm immediately below the elbow. The straps must be outside the measurement region.

Select Position from the New Measurement toolbar. The scanner arm moves to the approximate

start position. For forearm measurements, be careful that the scanner arm does not bump the patient's head.

6. Use the graphic shown on the New Measurement screen to adjust the position of the laser light. The Laser Light is positioned in the center of the wrist, adjacent to the ulna styloid. 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. The forearm bones should be centered and straight.

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7. Select Start from the New Measurement toolbar to start the measurement. Monitor the image to make sure it is correct.

Make sure the forearm is in the center of the image and the distal end of the ulna (1) is shown near the top of the image. If the image is not correct, select Abort, reposition the laser light, and restart the measurement.

Select Close to exit the New Measurement screen. Refer to the topic New

Measurement screen for additional screen functions.

3.2.6 Lateral Spine/LVA measurement Option

1. Put the lateral positioner o n the table.

Positioner A should unfold and set over the back rail of the table. Positioner B (1) should be placed on top of the spine strap (2) 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. Refer to the figure below to complete the steps that follow.

• Set a pillo w on the table for the patient's head.

• Position the patient's knees toward the chest until the lower back and both shoulders are flat against

the lateral positioner.

• Make sure th e patient's spine is parallel to the scanner table.

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3. Positioner A: Refer to the figure below to complete the steps that follow for Positioner A:

• Place a pillow under the pa t ient's head.

• Set a foam wedge below t he bottom knee and between the knees for comfort.

• Make sure th e patient's back and hips are flat against the positioner.

• Patient's arms should be 90-degrees from the chest.

4. Positioner B: Refer to the figure below to complete the steps that follow old 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 betwee n the patient' s thigh s 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.

Select Position from the New Measurement toolbar. The scanner arm moves to the approximate

position.

start

6. Adjust scan length or width as needed. LVA Morphometry scan length can be increased to 55.4 cm. LVA Spine Geometry scan length should be increased to 69.5 cm. For patients that a unable to re st 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. 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.

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Lateral Spine measurement

End in L1

All posterior

elements visible

2.5+ cm tissue Start in Sacrum so

that all of L5 is visible

Laser Light

LVA Morphometry measurement

2.5+ cm tissue

Laser Light

End near T4

All posterior

elements visible

Start at Sacrum so

all of L5 is visible

Note: An LVA measurement only produces BMD results when SmartScan is turned off. When SmartScan is on, the scan time is reduced.

LVA Spine Geometry measurement End near C1

All posterior elements visible

Start in Sacrum so all of L5 is visible

2.5+ cm tissue

Laser Light

Select Start from the New Measurement toolbar to start the measurement. Monitor the image to make

sure it is correct.

8. Make sure the image is correct.

• 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 verteb rae.

• The image ends in L1 for a Lateral Spine measurement, near T4 for an LVA Morphometry

measurement, or near C1 for a LVA Spine Geometry Measurement.

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• All of the posterior elements appear in the image.

• The edge of the positione r may appear in the image. This is not a problem.

If the image is not correct, select Abort, reposition the laser light, and restart the measurement.

If you have completed measurements for the patient, select Home to move the scanner arm to the

Home position.

10.

Select Close to exit the New Measurement screen. Refer to the topic New Measurement screen for

additional screen functions.

3.2.7 APVA Measurement Option

1. Follow the same scan procedure that is typically for AP Spine measurements.

Select Position from the New Measurement toolbar. The scanner arm moves to the approximate

start position. APVA Morphometry scan length can be increased to 55.4 cm. APVA Spine Geometry scan

length should be increased to 69.5 cm.

3. 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. End the scan in T4 for APVA Morphometry Measurement or near mandible for APVA Spine Geometry Measurement.

APVA Morphometry Measurement Center and Square

Patient

End at T4

Laser Light ~5 cm below navel

Start in L5

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APVA Spine Geometry Measurement

Center and Square

Patient

End at

Mandible

Laser Light ~5 cm below navel

Start in L5

4. Select Start from the New Measurement toolbar to start the measurement. Monitor the image to make sure it is correct.

5. Make sure the image is correct. If the image is not correct, select Abort, reposition the laser light, and restart the measurement.

If you have completed measurements for the patient, select Home to move the scanner arm to

the Home position or select next.

Select Close to exit the New Measurement screen. Refer to the topic New Measurementscreen

for additional screen functions.

3.2.8 Dual VA Measurement Option

Dual VA measurement includes both APVA and LVA measurements in one exam .

3.2.9 Total Body Measurement Option

1. Make sure all attenuating materials (belts, metal buttons, etc.) are removed from the measurement region. For Total Body scans, all materials that may cause significant attenuation must be removed.

2. Help the patient onto the scanner table and position the patient as follows: 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. Note: If a patient is wider than the scan area, the patient can be positioned for a half body scan. In addition to all of the left or right side of the body, the entire head and spine should be included in the scan window.

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B the patient’s hands are turned on sides with thumbs up, palms facing legs and arms are alongsi de the

patient’s body. If possible, hands should not touch legs. Verify that the patients arms are within the scan area lines on the table pad. C velcro strap

A B C

3. Select Position from the New Measurement tool bar. The scanner arm moves to the approximate start position.

4. A graphic is shown that gives the correct patient position and measurement start position for the site you are measuring. Remove the patient’s shoes. Make sure the patient’s head is approximately 3 cm below the horizontal line on the table pad. Use the velcro straps to secure the patient’s knees and feet to prevent movement during the measurement. Note: You are not required to adjust the scan arm position for Total Body measurements.

Select Start from the New Measurement toolbar to start the measurement.

6. 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 patient’s arms (3) are shown in the image.

If the image is not correct, select Abort and reposition the patient.

If you have completed measurements for the patient, select Home to move the scanner arm to

the Home position.

Select Close to exit the New Measurement screen. Refer to the topic New Measurement

screen for additional screen functions.

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3.2.10 Hand Measurement Option

1. Set the patient in a chair next to the scan table. 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. Note: Use a chair without arms or wheels. Use the same chair for all hand measurements to get optimal precision. Note: Lunar iDXA scanners also have an option to scan the patient in a non-seated position with the scan positioner under the hand (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 (iDXA

only)

Seated

Laser Light: In

center of wrist,

adjacent to ulna

styloid

Fingers and thumb flat and together

Select Position from the New Measurement toolbar. The scanner arm moves to the approximate

position. For hand measurements, be careful that the scanner arm does not bump the patient's head.

start

Position hand 2 cm from the line on the table pad, fingers and thumb flat and together

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3. Use the graphic shown on the New Measurement screen to adjust the position of the laser light. If necessary, move the positioner and the patient's arm so that the laser light shines in the center of the wrist, adjacent to the ulna styloid.

All of the Ulna Styloid is visible

Let scan proceed past all fingertips

Laser Light: In center of wrist, adjacent to ulna styloid

Select Start from the New Measurement toolbar to start the measurement.

5. Monitor the image to make sure it is correct. Make sure the scan proceeds past all fingertips, and make sure that all of the ulna styloid is visible. If the image is not correct, select Abort and reposition the patient.

If you have completed measurements for the subject, select Home to move the scanner arm to the

Home position.

Select Close to exit the New Measurement screen. Refer to the topic New Measurement screen for

additional screen functions.

3.2.10 Small Animal Body Measurement Option

CAUTION: This software is for investigational use on laboratory animals or for other tests that do not involve

human subjects.

WARNING: Proper cleaning and handling procedures must be followed to prevent the

possibility of cross-infections between subjects scanned on the same system. Clean and disinfect the system according to your local and country-specific hygienic

regulations. Protect table pad and table top from wetness and prevent the ingress of liquid into the scanner by protectively covering the scanner with a waterproof nonattenuating material. Some plastics and vinyls may have unique x-ray attenuation properties that could affect results.

1. Make sure all attenuating materials (metal, etc.) are removed from the measurement region.

2. Position the subject on the scanner table. Center specimen on center line, placing the head toward head end of the table, start a few centimeters above the head.

Select Position from the New Measurement toolbar. The scanner arm moves to the approximate

start position.

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4. Select Start from the New Measurement toolbar to start the measurement of few centimeters above the head.

5. Monitor the image to make sure it is corre ct. If the image is not correct, select Abort and reposition the subject.

3.2.11 Abort measurement

If you want to complete another measurement for the subject, select Set Up from the New

Measurement toolbar.

If you have completed measurements for the subject, select Home to move the scanner arm to the

Home position.

Select Close to exit the New Measurement screen. Refer to the topic New Measurement screen for

additional screen functions.

Select Abort (F5) from the New Measurement toolbar if the image is not correct or if you determine that a sufficient area of the measurement is obtained. When you select Abort, the measurement stops automatically when the detector reaches the edge of the scan window. A message shows the options that follow:

• "Resume Me asurement"–Select this option to continue the measurement that you chose to abort.

• "Save Measurement"–Select this option to save the current measurement.

• "Do not save measurement. Reposition this 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

• "Do not save measurement. Set up a new measurement."–Select this option to change the settings for the measurement.

3.3 Pediatrics Option

The Pediatric option provides BMC, BMD and Z-Score values for females and males who are 5-19 year s old.

Measurement procedures are the same as the procedures for adult patients.

Reference values are available for AP spine, Femur and Total body measurements. When a patients age is less than 20 years, additional pediatric patient information fields appear automatically.

Pediatric Skeletal Age and Pubertal Stage. This information is obtained by the physician through other means.

3.4 OneScan

OneScan™ performs a AP Spine and DualFemur exam without repositioning between scans. OneScan™ d oes not use the foam leg block positioner for spine positioning.

3.4.1 Configuring OneScan On/Off

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The OneScan option can be defaulted on or off through User Options/ Measure. A pause may be enabled to occur between femurs (DualFemur) or between AP Spine and Femur scans.

See OneScan Measurement below. The Position screen also includes a OneScan checkbox. If the patient has had a previous scan, the

software will auto-select the matching OneScan option for trending. (Determine if the OneScan feature was on or off through examination of the analysis screen under the

Information tab.)

3.4.2 Positioning the Patient

The positioning graphics are tied directly to the configurable OneScan checkbox. The graphics will change slightly, depending upon the configuration selected.

Graphics: OneScan ON

Graphics: OneScan OFF

Positioning the patient remains the same if you choose to not use the OneScan option. However, if you are using OneScan, the following positioning should be utilized:

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 to align the patient.

2) The patient's arms should be crossed over the chest, away from the side of each hip.

3) Align the centerline on the scanner table with the guide on the base of the foot brace.

4) Internally rotate the patient's legs, and secure the patient's feet to the foot brace (GE-Lunar suggests not removing shoes).

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3.4.3 OneScan™ Measurement

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 indicated below 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.

Note: OneScan is intended to be used without A Pause may be enabled between scans. This option is found in Tools/User Options / Measure tab.

Check the desired options.

the leg block.

3.5 OneVision Feature

The OneVision feature allows the user to set up multiple measurements within one exam. This eliminates keystrokes and improves throughput for customers that routinely perform multiple measurements on each patient. OneVision feature is required for DICOM or HL7 reporting interfaces. By default, the enCORE software includes the exam combinations of AP Spine + DualFemur or AP Spine + DualFemur + LVA. Exam combinations can be found at the top of the Exam list. The images included in the Exam are displayed in tab view above the skeletal image.

When scanning with a series of OneVision scan types, the exam or Repeat the current measurement. Refer to Measurement procedure for details on how to obtain an appropriate image measurement.

select Next to proceed to the next image site in

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3.5.1 Create Exam Protocols

The user may create their own exam protocols with the OneVision feature. Select Create Exams from the Measure menu on the Windows Tool bar.

Select the New button to create an exam protocol. The user may also delete, rename, or edit existing exam protocols from the Create Exam dialog.

Enter a protocol name in the box provided. It is recommended to enter a name that describes either the images included in the exam or a specific description of the exam. Then, select OK.

Once the protocol name is entered, you may define the measurement sites included in the exam and the sequence of the measurements in the exam. Select the image site from the available sites on the left and select Add to add the image site to the Exam. Use the Up or Down buttons to modify the sequence of image measurements in the exam. When you have finished, click OK.

3.6 Orthopedic Hip Option

The Orthopedic option lets you get BMD, BMC, and Area values for patients with femur implants. This option is available for research purposes and is only available if you purchased the orthopedic option.

To perform a patient measurement, first select or record the patient as described in Section 3.1. Then, select Left Ortho or Right Ortho in the Exam list on the New Measurement screen.

Information about the measurement modes is located in the Safety Information and Technical Specifications manual located in the Help topics.

3.6.1 Position Patient

Select Position from the New Measurement toolbar. The scanner arm moves to the approximate

start position. The patient should be centered and square on the table.

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Use the centerline on the scanner table as a reference. The patient's arms must be crossed over the chest, away from the side of each hip. Place the foam knee positioner under the knee of the leg to be scanned, with the tapered end toward the patient's thigh. The foot of the leg to be scanned should be strapped to the vertical side of the foot brace. The leg should be in a neutral position, NOT rotated as in the femur scan. You should also position the leg so the femoral shaft and implant are parallel with the centerline on the scan table.

Refer to the topic Measurement procedures for additional information.

3.6.2 Adjust Measurement Start Position

Use the graphic shown on the New Measurement screen (shown when you select Position from the New Measurement toolbar) to adjust the position of the laser light. Position the laser light mid-thigh, approximately 3-4 cm below implant tip.

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3.6.3 Start measurement

Select Start from the New Measurement toolbar to start the measurement. Monitor the image to make sure the (1) scan is initiated 3-4 cm below the implant tip, (2) femoral shaft and implant are perpendicular to the scan path, (3) scan continues 2-3 cm above the greater troc hanter.

3.7 Quick View

QuickView offers a fast, 10 second Spine or Femur scan that may be useful for quick review of a region. This

option provides a BMD and T-Score value for females and males who are

T > 20 years of age. Measurement

and procedures are the same as other scan mode procedures. Analysis Standard scan modes provide optimal precision and are recommended for follow-up scans to monitor changes in BMD. Determine precision with the scan mode used to monitor patients. The larger pixel width of QuickView results in reduced resolution.

For more details on the scan mode specifications, review the Safety and Specification help file.

3.8 Spine Phantom Procedure

While many instruments require a separate Quality Control to be run in addition to the Quality Assurance, the enCORE based scanner does not require this separate measurement. The daily QA procedure run on the scanner both calibrates the machine, and also has “bone” chambers that are used for Quality Control measurements. This removes the necessity of requiring a phantom to be measured by the user for separate control measures. The phantom is considered a service tool. Every system includes an aluminum spine phantom and water container. An encapsulated phantom is available for purchase.

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Water Container Encapsulated

A Spine Phantom baseline was performed with the installation of your scanner. This will be found within the patient database. For general use, use the same patient information that was established with that Spine Phantom scan. NOTE: The procedure below assumes you are familiar with AP Spine scan and Analysis procedures.

3.8.1 Measure the Spine Phantom.

Put 15 cm of water in the plastic container and position the aluminum phantom in the middle of the plastic container. Position the phantom so that L5 is toward the foot of the scanner.

1. From the Main Menu screen, select F2 (Measure).

2. Have you measured the phantom before?

• If yes, select the phantom from the patient list and continue to step 5.

• If no, continue to step 3 to record the information for the spi ne phantom.

3. Record the primary information in the dialog box.

• 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,

2006, type 09/28/1964. DO NOT change this date for future Spine Phantom measurements.

• Height: 67 inches

• Weight: 154 pounds or 70 kilograms

• Sex: Male

• Ethnic Group: White

4. Select the secondary tab and record the following information:

• Facility ID: Record the phantom numb er given on the L5 region of the spine phantom.

• Department ID: Record your System ID number. This number is located in the User Options-System

tab.

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

6. Position the laser cross-hair in the on the letter “R” in the word “LUNAR” on the L5 vertebral body of the phantom. Start the scan.

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T12 L1 L2

Once approximately half of T12 is imaged, select Abort from the toolbar.

Choose Save measurement from the Save Dialog Box and select OK if the measurement was performed correctly.

L4 L5

For spine phantom analysis it is necessary with 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.

In the Analysis screen, select ROI's tool to view this information.

4.0 Analysis Procedures

4.1 Basic Analysis Procedures

4.2 AP Spine Analysis

4.3 APVA - Morphometry Analysis

4.4 APVA - Spine Geometry Analysis

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4.5 Femur Analysis

4.6 Advanced Hip Assessment

4.7 Total Body Analysis

4.8 Composition Analysis

4.9 Lateral Spine Analysis

4.10 LVA - Morphometry Analysis

4.11 LVA - Spine Geometry Analysis

4.12 Forearm Analysis

4.13 Hand Analysis

4.14 Orthopedic Analysis

4.15 Pediatric Analysis

4.16 Small Animal Analysis

4.17 Custom Reference Population

4.18 ScanCheck™

4.19 Practice Management Tools

4.20 Composer Reports

4.21 DXA Results Report

4.22 Precision Calculator

4.23 Custom Analysis

4.24 FRAX 10-year fracture risk

AT ALL TIMES, let the program perform the analysis unless the scan image obviously must be corrected.

4.1 Basic analysis procedures

Note: The results tabs for AP Spine, Femur, Forearm and Total Body images include a ScanCheck™

(computer assisted densitometry) The list of Yes/No questions should be used to assist in analysis. There is a space for comments. You can print the checklist by selecting to print ScanCheck™ in the Report Center. Refer to ScanCheck™ Section for more information.

4.1.1 Select Image

1. From the Main screen, select Analyze. (From the Directory screen, select the patient from the Patient list. Use the Search option to locate a patient in a large database).

2. Select the image to analyze from the Image list,

3. Select OK (or the Analyze button from the directory screen).

4. enCORE typically performs the analysis automatically. Do not change ROIs or Point Typing unless the analysis shows an obvious need for corrections

4.1.2 Adjust Image

Select Imaging from the Analyze toolbar to adjust the image: the Image Tools window is shown.

Use this window to change the gray levels of the image and zoom the image.

Image Tools Window

The Image Tools window shows a bone profile and gives the options that follow:

• Brightness-To adju st the brightn ess for the image, click and drag the brightness scroll bar right or left. Select OK.

• Contrast-To adjust the contrast for the image, click and drag the contrast scroll bar right or left. Select OK.

• 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.

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• Zoom-To zoom the image, use the bar to scroll through the percentage values. Select OK. Use the

Pan tool if the image is larger than the window area on the Analyze screen.

Check Show Advanced Features to adjust Threshold, Range, Black/White Controls, or Image Type and to reset contrast.

• Threshold-To adjust the threshold, select the Threshold option and either move the vertical lines that are shown on the bone profile, enter values in the black/white fields, or adjust the Brightness/Contrast controls. Select OK.

• Range-To adjust the range, select the Range option and either move the vertical lines that are shown on the bone profile or enter values in the black/white fields. Select OK.

• Black/White-Enter a value in the Black and White fields. Select OK.

• Type-Click the drop down menu and choose between the following image types: Enhanced

Bone, Tissue, and Unfiltered Bone. Select OK.

• Reset Contrast-Select Reset Contrast to reset settings. Select OK.

Use the tools given in the following table to magnify an image during analysis. These tools are shown on the Analyze screen:

Icon Tool Description

Reset

Mode

Zoom

Image

Pan

Image

Select to deactivate the Zoom and Pan Image tools.

Move the cursor over the image and use the Zoom Image tool to activate mouse control to zoom in or out on the image.

If you zoom the image larger than the viewable area on the screen, use the Pan Image tool to view hidden areas of the image. Select the Pan Image tool, then drag the cursor to move the image.

Zoom

Image

Move the cursor over the image and use the Zoom Image bar to zoom in or out on the image.

4.1.3 Advanced: Adjust ROIs

ROIs do not need to be adjusted in most circumstances. The procedures for adjusting ROI position are specific to each measurement site. Caution: Some ROI adjustments will render the results unreliable. See the specific scan type recommendations for analysis.

4.1.4 Advanced: Adjust Point Typing

enCORE analysis automatically assigns point typing to a scan and usually requires no adjustment. Significant changes to Point Typing will affect both the results and reproducibility of a scan. The procedures that follow give instructions to examine and adjust point typing for an image (only Artifact point typing can be adjusted for Total Body analysis).

DO NOT adjust the point typing unless the program has made obvious errors. Change the point typing only if the area that needs to be changed is larger than the default cursor size. It is recommended that changes be limited to Bone and Neutral point typing.

A tool that lets you 1) view how the program classified the sample points, and 2) change the classification if

necessary. The point typing determines the placement of bone edges.

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Select Points from the Analyze toolbar: the Point Type window is shown. The program automatically determines if a sample is bone, tissue, neutral, air, or artifact:

• Bone- Verify that the bone is typed as Bone.

• Artifact- Foreign material to be excluded in analysis.

• Tissue–Tissue point typing is specific to each measurement site.

• Neutral–Select the Neutral brush type and verify that a thin border of neutral samples is shown

around the bone.

DO NOT adjust the point typing unless the program has made obvious errors. Change the point typing

only if the area that needs to be changed is larger than the default cursor size. Only change the Bone and Neutral point typing. To adjust point typing, select a brush type (Bone or Neutral) and a brush size. Click on the image to make your changes.

If necessary, select the Artifact brush to point type an artifact in the image.

Select Reset to return the image to its original state.

Select Undo to correct errors you make while adjusting the point typing.

Examples of correct bone point typing AP Spine correct bone point typing

Femur correct bone point typing

Forearm correct bone point typing

Lateral spine bone point typing

Refer to the specific scan type Analysis for further information.

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4.2 AP Spine Analysis

Note: The results include ScanCheck™ tab. Use ScanCheck™ to assist in the analysis of the image and to

help you make corrections where necessary. See the section on ScanCheck™ for more information.

4.2.1 AP Spine analysis procedure

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. Complete the steps below to complete an AP Spine analysis:

1. Select an image file for analysis. If necessary, select Imaging from the Analysis tool bar to adjust the image. If necessary, select ROIs from the Analyze toolbar to adjust the ROIs. 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). Select Results to view the analysis results.

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Use the tools given if it is necessary to adjust ROIs for an AP Spine image:

Icon Tool Description

Add ROI

This tool is shown when you select ROIs. Select the Add ROI tool 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 the Label ROIs tool to label the ROIs accordingly.

Delete ROI

Move ROI This tool is shown when you select ROIs. Select the Move ROI tool to move

Rotate ROI This tool is shown when you select ROIs. Select the Rotate ROI tool to rotate an

Label ROIs This tool is shown when you select ROIs. Select the Label ROIs tool to relabel

Exclude ROIs

This tool is shown when you select ROIs. Select the Delete ROI tool to remove an ROI during AP Spine analysis: use the left mouse button to click on the ROI, then select the Delete ROI tool. Select the Label ROIs tool to relabel the ROIs if necessary.

ROIs.

ROI.

ROIs after you have added or deleted an ROI from an image.

The Exclude ROI tool lets you remove ROIs from AP spine results. Select the Exclude ROI tool, 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™

Markers

This tool allows you to show/ hide ScanCheck™ markers that indicate a possible high density area, such as an artifact or osteophyte.

If necessary, select Points from the Analyze toolbar to adjust point typing. DO NOT adjust the point typing unless the program made obvious errors. If you adjust point typing,

2. Select Results to view the new analysis results based on your changes.

Bone Points

Neutral Points

Tissue Points

3. Select Save to save your changes, or select Close then No if you do not want to save your cha nges.

Refer to Basic Analysis Procedure for additional AP Spine Analysis information.

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4.3 APVA Morphometry Analysis

4.3.1 APVA Morphometry analysis procedure

Complete the steps below to complete an APVA analysis. Select an image file for analysis. If necessary, select Imaging from the Analysis tool bar to adjust the image.

Icon Tool Description

Morphometry

1. Click on the vertebra you want to analyze, and select a label for the vertebra. The Morphometry Wizard opens.

Wizard

Change Deformity

Indication

Delete ROI

Select this tool to start the Morphometry Wizard. The Morphometry Wizard helps you label, measure, and assign deformities to the vertebrae. Select Change Deformity Indication to change the deformity assessment for a vertebra.

Click on the Delete tool and then click the target ROI.

2. Select a deformation for the vertebra. 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.

3. Select Save to save your changes, or select Close then No if you do not want to save your changes. Refer to Basic Analysis Procedures for additional APVA Analysis information.

Note: If you chose Dual VA, the exam includes APVA and LVA measurements. Refer to LVA Analysis for more information.

Image contrast may be inverted. Go to Tools/ User Options / Images tab. Check the option to Invert

Images.

4.4 APVA Spine Geometry Analysis

APVA Spine Geometry features only appear in the enCORE software if you purchased the APVA Spine Geometry option for your bone densitometer.

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4.4.1 APVA Spine Geometry Analysis Tools

Icon Spine Geometry

Analysis Tool

Move / Size ROI Rotate ROI Delete ROI Add ROI Label ROI Angle Show/Hide ROIs

Description

Click on the Move / Size ROI tool. Click and drag ROI or edges as needed. Click on the Rotate ROI tool. Click and drag near the end of the ROI. Click on the Delete tool and then click the target ROI.

Click on Add ROI tool and then select desired ROI from menu. Select ROI to relabel, then click Label ROI tool. Choose desired label from menu. After at least two ROIs have been added, the Angle tool will activate. Click Angle tool to change angle configurations. Onscreen control to show or hide ROIs.

4.4.2 APVA Spine Geometry Analysis Procedure

The software will automatically place the ROIs in most cases. The vertebrae used for analysis are define d as the last vertebral bodies at extreme ends of the spinal curvature, where the end plates tilt to the side of curvature concavity. Use the APVA Spine Geometry Analysis tools to adjust ROIs. In patients with multiple spinal curves, each component can be measured. To add additional ROIs:

1. Click the Add ROI button or press the Insert key on keyboard. The Add ROI menu should appear.

2. Select the superior end vertebra from the menu and move the ROI line through and parallel to the superior end plate on the superior end vertebra using the Spine Geometry analysis tools, if necessary.

3. Click the Add ROI toolbar button or the Insert key on the keyboard again. The Add ROI menu should appear again.

4. Select the inferior end vertebra and move the ROI line through and parallel to the inferior end plate on the inferior end vertebra using the Spine Geometry analysis tools, if necessary.

The Cobb Angle (degrees) will show to the right of the scan image under the Geometry tab in the Geometry table:

5. Three reports are available for APVA Spine Geometry Reporting:

APVA Spine

displays the APVA scan image and any Cobb Angle analysis.

Geometry Dual VA Spine Geometry

displays the LVA and APVA scan images only. This report is only available if the exam contains both LVA and APVA scans.

Standard Dual VA Spine Geometry

displays the Cobb Angle analysis without images. This report is only available if the exam contains both LVA and APVA scans.

Ancillary

Refer to Basic Analysis Procedures for additional Analysis information.

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4.5 Femur/ DualFemur Analysis

Note: The results tabs for Femur images include a ScanCheck™ tab with a list of Yes/No questions. These

questions should be used to assist in the analysis of the image and to help you make corrections where necessary. The answers to the questions can be recorded on the tab. The tab also includes space for comments. To print the checklist, select Print ScanCheck™.

4.5.1 Femur Analysis Procedure

1. Select an image file for analysis. Note: When you open a DualFemur image for analysis, the left and right femur image s 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. DO NOT adjust the point typing unless the program made obvious errors. If you adjust point typing, select Results to view the analysis results based on your changes.

Bone Points

Neutral Points

Tissue Points

4. Typically 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.

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5. GE Healthcare LUNAR does not recommend adjusting the Neck ROI.

Select the Search tool to position the neck ROI correctly. Search locates the region of the

lowest BMD and most narrow area of the neck. If it is necessary to perform further adjustments, select the ROI tool from the Analysis toolbar to complete the procedures that follow:

• Move–Select the Move ROI tool. Use the cursor to select and move the Neck ROI and the Neck Axis.

• Rotate–Select the Rotate ROI tool. Use the cursor to select and rotate the Neck ROI and the Neck Axis.

• Lengthen ROI–Select the Size tool. Use the cursor to include tissue on either side of the neck if none is present. Never edit the Neck ROI width.

6. Select Results to view the analysis results.

7. Select Save to save your changes.

Refer to Basic Analysis Procedure for additional Femur Analysis information.

4.6 Advanced Hip Analysis

The values computed by this software option are used to estimate the structural properties of the hip. The values are not for clinical diagnosis of a disease.

4.6.1 Advanced Hip Analysis Options

Advanced Hip Assessment Results are available for Femur and DualFemur™ reports. Advanced Hip Assessment Results (AHA) includes upper neck regi on, lower neck region, hip axis length (HAL) and hip strength results. AHA is a purchased software feature.

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Go to Tools / User Options / Analyze tab to enable these options.

4.6.2 Advanced Hip Assessment

Advanced Hip Assessment (AHA) includes all the standard femoral regions of interest previously available. In addition, AHA provides a measurement of two new regions of interest-upper and lower femoral neck, automated determination of hip axis length, and hip strength values.

1. Lower Femoral Neck

2. Trochanter

3. Ward's

4. Shaft

5. Total Hip (defined as the density of the combined region of the femoral neck, trochanter, and shaft regions.

6. Upper Femoral Neck

7. Hip axis length (HAL)

4.6.3 Hip Axis Length

HAL can be found on the AHA tab under the Hip Axis Length Comparison chart. This DualFemur measurement example indicates a comparison mean of 108.7 mm. The patient's right hip axis length is

100.2 mm and the left hip axis length measured 100.2 mm.

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4.6.4 Upper Neck and Lower Neck Regions

Upper Neck ROI (indicated in red on this

image) includes the bone above 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 (indicated in red on this image) 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.

Upper Neck Reference Data

Comparison to Reference Data is available for the upper neck region. Femur upper neck reference data ia available for both males and females for the following reference populations: USA, Germany, Australia, UK, Brazil, and Finland. Both Young Adult and AgeMatched 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 the "Neck" in the region table.

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4.6.6 Hip Strength

Provides an index of hip strength by combining BMD, Femur Geometry, Age, Height and Weight. 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 Absorbtiometry.

Hip Strength Index = strength / stress where,

strength = 185 - 0.34(age - 45); Age >45 years stress = moment * y / CSMI + force / CSA

1/2

moment = d1 * 8.25 * weight * 9.8 (height / 170)

* cos(180° - θ)

force = 8.25 * weight * 9.8 * (height / 170)

1/2

* sin(180° - θ)

d1 = Distance along the neck axis from the center of the femoral head to the section of minimum CSMI. y = Distance from center of mass to the upper neck margin, along the section of minimum CSMI.

θ) = Angle of the intersection of the neck and shaft axes

theta (

The value is not for clinical diagnosis of disease.

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4.6.7 Hip Geometry

Definitions

CSA Cross-sectional area CSMI Cross-sectional moment of

inertia Alpha (α) Theta

Angle of shaft axis with

respect to vertical

Shaft-neck angle (θ) y Dista nce from the center

of mass to the superior

neck margin 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

4.7 Total Body Analysis

4.7.1 Total Body Analysis Procedure

Both the bone and soft tissue images are shown when you open a total body image for analysis. Changes you make to the cut positions on one image are also made on the other image. You can turn off the dual image option in the User Options Image tab. Refer to the topic Options for further information on configuring User Options.

Complete the steps below in the order given to complete a Total Body analysis: Select an image file for analysis. Select Imaging and adjust the image if necessary.

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4.7.2 Total Body Cuts

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 l

eg.

Adjust Cuts

Select the Select the

ROI tool from the Analysis toolbar.

Move Vertex tool. Adjust the cut itself or select a vertex to adjust the cut position.

Icon Tool

Move Vertex

This tool is shown when you select ROIs. Select the Move Vertex tool if it is necessary to position ROI vertices or cuts.

Select Results to view the analysis results. Select Save to save your changes or select Close then No if you do not want to save your changes.

4.7.3 Total Left / Total Right 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.

4.7.4 Half Body Scan to Estimate Total Body

For very wide patients that do not fit within the scan boundaries it is recommended that the analysis of half of the body be done.

Description

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In this example, only the entire right half of the body fit into the scan area.

Click on the tool to estimate one side of the body from the other.

4.8 Composition Analysis

Composition results are shown on the screen when you select the Composition tab in the Analyze window.

• Fat as a percentage total tissue and as a percentage of region tissue.

• Total mass in kilogram s or pounds.

• Grams or pou nds of soft tissue, fat tissue, and lean

tissue.

• BMC in gram s or pounds.

• Centile or Z-score

• BMI

Options for Centile or Z-score and Metric or English (US) results are found under Tools / User Options / Results Display / Composition Options

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 the 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.

Note: Estimated Total Body %Fat is only available with OneVision Exams comprised of AP Spine plus Femur.

Left Total / Right Total Regions

The option to generate total left and total right regions is located in Tools / User Options / Analyze / Total Body Analysis Options. Check the option box to enable "Calculate

Left/Right Total Body" results.

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4.8.1 Composition Measurement of Android and Gynoid Fat

Android and Gynoid Composition ROIs are available in analysis.

Basic ROI descriptions: Android ROI = Lower boundary at Pelvis cut. Upper

boundary above Pelvis cut by 20% of the distance between Pelvis and Neck cuts. Lateral boundaries are the Arm cuts. Gynoid ROI = Upper boundary below the Pelvis cut line by

1.5 times the height of the Android ROI. Gynoid ROI height equal to 2 times the height of the Android ROI. Lateral boundaries are the outer Leg cuts.

The A/G ratio is between the %Fat of the Android (central) and %Fat of the Gynoid (hip and thigh) regions. The Enhanced Composition report page will display the Android/Gynoid ratio.

4.8.2 Composition BMI ( Body Mass Index )

BMI reference graph is from the World Health Organization's classification. BMI has been added to the Composition display tab if the composition results option is selected. 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 4 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)

Body Composition BMI Graph is available in Composer Reports as an option. Note: 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.

4.8.3 Composition Trending Options

The options to change trending graphs is found on the Composition Trend tab in the Analysis Screen.

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1. Choose Region to trend from drop down menu

2. Choose a Display option

3. If Change vs. is selected for Display

option, choose a Trend On option for Y1 only. This will plot %Change vs Previous or Baseline for Y1.

4. If Absolute Value is selected for the Display option, two Trend On options will appear for Y1 and Y2. Y1 is represented in black and will appear on the left axis and Y2 is represented in magenta and will appear on the right axis.

Additional Trend On options A/G Ratio and Total Body (%Fat) are available.

Line Pattern and Change vs. Previous or Baseline options are set under Tools / User Options /

Trending / Trend Graph Options.

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Display, Y1, and Y2 options can also be changed under Tools / User Options / Trending.

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Composition trending tables will display the Composition Trend of the region selected and the Fat

Distribution.

4.8.4 Composition Report Options

Composition Ancillary Report

In addition to the main Composition report enCORE also features a composition ancillary report. The Ancillary report page includes fat mass ratios of Trunk/Total, Legs/Total, and

(Arms+Legs)/Trunk. Enhanced Composition Report

enCORE also features an Enhanced Composition option. This report provides the Composition Reference Graph, a Composition Trend Graph, a Fat Distribution Table and the WHO BMI reference chart.

4.8.5 Estimated Total Body %Fat and Android/Gynoid %Fat

Using the scan tissue data from standard spine and femur scans, it is possible to make an estimate of the total body %Fat and Android/Gynoid %Fat. The required scan types are as follows:

• An exam with AP Spine and a Femur.

• An exam with AP Spine and Dual Femur (avera ged value).

A Composition tab in the analysis screen for Spine/Femur exams, displays a reference graph, BMI graph, and table that includes Tissue (%Fat), Tissue (%Lean), and Centile.

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The Estimated Total Body exam report found in the Report Center for Spine/Femur exams includes a reference graph, trend graph (when applicable), BMI graph, and table that includes Tissue (%Fat), Tissue (%Lean), and Centile are displayed.

4.8.6 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 below for details).

Caucasian Range Limits for Valid Total Body %Fat Estimation Variables

Female

Male

Limits Age Height

(cm)

min 20 130 40 15 2 11 10 10 10

max 100 185 135 48 55 27 50 25 60

min 20 150 50 15 2 13 10 12 10

max 100 200 125 45 55 29 40 22 45

Weight (kg)

BMI Spine

%Fat

Spine Thickness (cm)

Femur % Fat

Femur Thickness (cm)

Predicted Total Body %Fat

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Caucasian Range Limits for Valid Android & Gynoid %Fat Estimation Variables

Limits Age Height

(cm)

Female min 20 130 40 15 2 11 10 10 10 22 0.3 2

max 100 185 135 45 55 27 50 23 60 62 1.25 61

Male min 20 150 55 18 2 15 10 12 10 20 0.75 18

max 100 200 125 42 53 28 40 22 45 49 1.6 53

Weight (kg)

BMI Spine

%Fat

Spine Thickness (cm)

Femur %Fat

Femur Thickness (cm)

Predicted Total Body %Fat

Gynoid

%Fat

A/G

Ratio

ndroid

%Fat

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 & 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

Limits Age Height

(cm)

Female min 20 140 34 14 5.85 10 9 9 5

max 90 180 90 35 4.79 21 45 17 50

Male min 20 150 35 14 4.79 11 10 9 5

max 90 180 92 31 46 22 40 17 43

Weight (kg)

BMI Spine %Fat

Spine Thickness (cm)

Femur %Fat

Femur Thickness (cm)

Predicted Total Body %Fat

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 & weight entered):

Asian Female spine thickness (cm): 7.861 + 0.06798*BMI

1.5

± 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

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4.8.7 Half Body Scan to Estimate Composition

For very wide patients that do not fit within the scan boundaries it is recommended that the analysis of half of the body be done.

In this example, only the entire right half of the body fit into the

scan area. Click on the to estimate one side of the body from the other.

tool then click on the tool

If the Total Body is derived from an estimate from half of the body, an "(e)" will appear next to the Region column in Densitometry and Composition results tables and next to the Measured Date column in Trend tables.

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4.8.8 iDXA Composition Color Mapping

iDXA enCORE software provides the option to color map the total body scan.

1. Click on the Color

2. Click on the Color Mapping Thresholds button

adjustments.

Mapping button the left of images in the

nalysis screen to display.

to make threshold

3. Default Tissue mapping colors are red, orange, and yellow where red represents an area of low level %Fat, orange represents an area of medium level %Fat, and yellow represents an area of high level %Fat. These colors are customized under Tools/User Options/Image/Image Colors.

4.8.9 Resting Metabolic Rate (RMR) and Relative Skeletal Muscle Index (RSMI)

Resting Metabolic Rate (RMR) and Relative Skeletal Muscle Index (RSMI) are Composer field codes.

RMR, which is synonymous with Resting Energy Expenditure (REE), is an estimate of how many

calories are burned at a resting state and represents the minimum amount of energy needed to maintain body temperature, heartbeat, and respiratory rate. RMR is calculated using Harris-Benedict equations [1]:

RMR (male) = 66.473 – (6.775 * age [yrs]) + (13.7516 * weight [kg]) + (5.0033 * height [cm])

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RMR (female) = 655.0955 – (4.6756 * age [yrs]) + (9.5634 * weight [kg]) + (1.8496 * height [cm]) RSMI represents the relative amount of muscle in the arms and legs and is calculated using the

Baumgartner equation [2]:

RSMI = (lean mass of arms [kg] + Lean mass of legs [kg]) / (height [m])

[1] Harris JA, Benedict FG. A biometric study of basal metabolism in man. Washington, DC: Carnegie Institute of Washington, 1919. (Carnegie Institute of Washington Publication 279).

[2] Baumgartner RN, Koehler KM, Gallagher D, Romero L, Heymsfield SB, Ross RR, Garry PJ, Lindeman RD (1998) Epidemiology of sarcopenia among the elderly in New Mexico. Am J Epidermiol 147(8):755-763.

4.9 Lateral Spine Analysis

Lateral Scans provide BMD values only.

4.9.1 Lateral Analysis

1. Do not make any changes to the locations of the ROIs unless the program made obvious errors.

2. Adjust the Body ROIs using either the arrow keys or the mouse. The Body ROI should be positioned with the top of the ROI just below the upper vertebral endplate and the bottom of the ROI just above the lower vertebral endplate.

• Each ROI should contain ONLY BO NE.

• Do not analyze B4 if the pelvis covers part of the vertebral bo dy.

• Do not analyze B2 if ribs cover part of the vertebral bo dy.

• Do not adjust the point typing unless the program made obvious errors. Select Points from the

Analyze toolbar to adjust point typing.

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Lateral Bone Points

Lateral Neutral Points

Lateral Tissue Points

3. Select Results to view the new analysis results based on your changes.

4. Select Save to save your changes or select Close then No if you do not want to save your changes. Refer to Basic Analysis Procedures for additional Lateral Spine Analysis information.

4.10 LVA Morphometry Analysis

LVA Morphometry features only appear in the enCORE software if you purchased the LVA Morphometry option for your bone densitometer.

4.10.1 LVA Morphometry Analysis Tools Icon Morphometry

Analysis Tool

Morphometry Density

Morphometry Wizard

Change Deformity Indication

Show/Hide ROIs

Delete ROI

Description

Select Morphometry to complete a Morphometry analysis of a LVA measurement. Select Density if a bone density analysis of a LVA is desired. This option is not during measurement. Select this tool to start the Morphometry Wizard. The Morphometry Wizard labels, measures, and assigns deformities to the vertebrae.

Select Change Deformity Indication and then click the target ROI to set or change the deformity assessment for a vertebra. Only use this tool to override automated morphometry analysis.

Onscreen control to show or hide ROIs. Morphometry reports do not show ROIs.

Click on the Delete tool and then click the target ROI.

available if you used SmartScan

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With the Morphometry Wizard enabled , the following tools become available after clicking a target ROI:

Icon Morphometry

Description

Wizard Tool

Move / Size ROI

Rotate ROI Adjust Vertices

Position Reference ROIs

Click on the Move / Size ROI tool. Click and drag ROI or edges as needed.

Click on the Rotate ROI tool. Click and drag near the corner, but inside the ROI to rotate the ROI. Click on the Adjust Vertices tool. Click and drag vertices as needed.

This tool is only available on LVA scans after reference vertebrae are identified. This will reposition the reference ROIs.

Label ROI

Click on drop down menu and select correct vertebra to label ROI.

ROI Suggestions

• Select the Move/Size ROI tool or the Rotate ROI tool to move or rotate an ROI.

• Select the Delete ROI tool to delete an ROI.

• Right-click an ROI and choose Relabel or click an ROI to enter the Morphometry Wizard and use the

Label ROI tool to re-label an individual ROI.

• Select Save to sav e changes or select Close then No if you do not want to save changes.

4.10.2 LVA Morphometry Configuration

The Morphometry analysis feature is available if you purchased the LVA option for your bone densitometer.

The enCORE software will provide the Morphometry results for the vertebrae of interest according to the parameters setup in Tools / User Options / Results Display / Morphometry Reference Options.

A. Z-Score Morphometry Mode uses Average Height, A/P and M/P ratios in the results and includes stature adjustment.

B. Percent Reduction (%) Morphometry Mode uses the ratio of posterior height to anterior height to check for Compression. Therefore, when Percent Reduction (%) mode is used, P/A ratios are provided. Checking stature adjustment while in Percentage Adjustment mode, provid es the additional output of Average height (%) values (Note: This requires the additional step of confirming the heights are set properly for L2-L4.).

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C. Cutoffs determine what deformity will be labeled as Mild, Moderate or Severe. Adjust if necessary.

4.10.3. LVA Imaging

Select the imaging tool to adjust the image. The ClearView bar enhances the bone edges of the

vertebrae. To invert the contrast of your images, go to Tools/ User Options / Images tab. Check the option to Invert Images.

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4.10.4 LVA Morphometry Analysis Steps

Select desired analysis type under Tools / User Options / Analyze tab and select the Morphometry options.

1. Enable Morphometry Wizard

then follow the steps for the analysis type selected.

I Create ROIs on Request (Recommended)

a) Click on a vertebra that appears deformed as close to the center of the vertebra as possible. b) The Morphometry Wizard window will open. 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. Re-do the auto-endplate finding by double-clicking in the exact center of the vertebra.

c) Click on Next. d) Click on L4 in the Morphometry Wizard window and click on Next. e) Verify the heights of L2, L3, and L4 and make changes as needed. These vertebrae will be

used as a reference. If any of the reference vertebrae are deformed, it will not be used in the stature adjustment. Click on Finish.

f) To analyze additional vertebrae, repeat steps a-b and click on Finish.

II Automatically create Reference ROIs when needed

a) Click on a vertebra that appears deformed as close to the center of the vertebra as possible. b) The Morphometry Wizard window will open. 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. Re-do the auto-endplate finding by double-clicking in the exact center of the vertebra.

c) Click on Finish. L2, L3, and L4 ROIs will automatically be created. d) Verify the heights of L2, L3, and L4. If changes are necessary, click on the vertebra to open

the Morphometry Wizard and make appropriate changes. e) To analyze additional vertebrae, repeat steps a-b and click on Finish.

III Automatically create ROIs for T8-L4 when opening exam

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a) T8-L4 ROIs will automatically be created upon opening scan for analysis. b) Verify ROI label and positioning. If changes are necessary, click on the vertebra to open the

Morphometry Wizard and make appropriate changes. c) To analyze additional vertebrae, click on a vertebra as close to the center as possible. The

Morphometry Wizard window will open. 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. Re-do the auto-endplate finding by double-clicking in the exact center of the vertebra. Click on Finish.

2. The software automatically assigns the Morphometry label, for all analysis types.

Symbol Label

Mild Wedge Moderate Wedge

Severe Wedge Mild Biconcavity

Moderate Biconcavity Severe Biconcavity Mild Compression Moderate Compression Severe Compression

3. To change a Morphometry deformity label, click on the "Change Deformity" icon

and then click on the vertebra of interest. A warning will appear, click OK. A list of deformities will be displayed. Select the desired deformity indication label. 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. Note: Only use this tool to override automated morphometry analysis.

4. Select Save to save your changes, or select Close then No if you do not want to save your cha nges.

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4.10.5 Trending Morphometry

1. Options to trend Morphometry on-screen are found under Tools/ User Options / Trending. Change Trend On option under Tools / User Options / Trending or on the Morphometry Trend tab in the analysis screen. Select A/P Ratio, Anterior Height, Average Height, M/P Ratio, Middle Height, P/A Ratio or Posterior Height.

2. Trend Graph Options are found under Tools / User Options / Trending / Trend Graph Options

3. Trend Table Options are found under Tools / User Options / Trending / Trend Table Options

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4. Options to trend Morphometry on DXA reports are found under Tools/ User Options / Reports /

Morphometry Report Options. Multiple trending selections can be made for a single report.

5. Composer Trending options are configured within the Compose r program. Refer to Basic Analysis Procedures for additional Analysis information.

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4.11 LVA Spine Geometry Analysis

LVA Spine Geometry features only appear in the enCORE software if you purchased the LVA Spine Geometry option for your bone densitometer.

11.1 LVA Spine Geometry Analysis Tools

4. Icon Spine Geometry Description

Analysis Tool

Move / Size ROI Rotate ROI Delete ROI

11.2 LVA Spine Geometry Analysis Steps

e software will automatically place the ROIs in mTh the last vertebral bodies at extreme ends of the spinal curvature, where the end plates tilt to the side of curvature concavity. Use the LVA Spine Geometry Analysis tools to adjust ROIs. To add additional ROIs

1. Click the Add ROI button or press the Insert key on keyboard. The Add ROI menu should appear. Select a vertebra and move the ROI line through the superior end plate of the chosen vertebra using

the Spine Geometry analysis tools, if necessary.

3. Click the ROI toolbar button or the Insert key on the keyboard again. The Add ROI menu appears

again.

Select another vertebra. Another ROI line is placed on the LVA scan. Move the ROI through the

inferior end plate of the chosen vertebra using the Spine Geometry analysis tools, if necessary.

e Cobb Angle (degrees) will show to the right of the scan image under the Geometry tab in the

Th Geometry table:

Add ROI Label ROI Angle Show/Hide ROIs

Move / Size ROI tool. Click and drag ROI or Click on the

edges as needed.

ROI tool. Click and drag near the end Click on the Rotate of the ROI. Click on the

Click on Add ROI tool and then select desired ROI from menu.

desired label from menu. activate. Click Angle tool to change angle configurations.

Onscreen control to show or hide ROIs.

Delete tool and then click the target ROI.

OI to relabel, then click Label ROI tool. Choose Select R

e been added, the Angle tool will After at least two ROIs hav

ost cases. The vertebrae used for analysis are defined as

5. e reports are available for LVA Spine Geometry Reporting:

Thre

A Spine

LV Geometry

displays the LVA scan image and any Cobb Angle analysis.

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Dual VA Spine Geometry Standa Dual VA Spine Geometry Ancilla

Refer to Basic Analysis Procedures for additional Analysis information.

displays the LVA and APVA scan images only. This report is available if the exam contains both LVA and APVA scans.

displays the Cobb Angle analysis without images. This report is only available if the exam contains both LVA and APVA scans.

only

4.12 Forearm Analysis

4.12.1 Forearm analysis procedure

1. Select an image file for analysis.

2. If necessary, select Imaging from

3. If necessary, select ROIs from the Analyze toolbar to adjust ROIs. 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 betwe

the Analyze toolbar to adjust the image.

en the radius and ulna.

Do not make any changes to the locations of the ROIs nless the program made obvious errors.

a. Select gth, and make sure the length of the patient’s forearm is co rrect.

Ico

n Tool Description

b. Select the Move Line to the correct location. All the ROIs move when you move the Reference Line.

Len

Length

This option is shown after you select ROIs during a Forearm analysis. Select Length to rearm length value. change the fo

/Size ROI tool or the Rotate ROI tool and move the Reference

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c. If the radial endplate is included within the UD ROI, move the UD ROI to just proximal the endplate.

DO NOT m

ove the 33% ROI after you correctly position the Reference Line. The program

positions the 33% ROI based on the location of the Reference Line.

4. If n g. DO NOT adjust the point

ecessary, select Points from the Analyze toolbar to adjust point typin

ping unless the program made obvious errors. If you adjust point typing, select Results to view the

ty new analysis results based on your changes.

Bone Points

Neutral Points Tissue Points

5. Select Save to save your changes or select Close then No if yo o not want to save your changes.

u d

Refer to Basic Analysis Procedure for additional Forearm Analysis information.

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4.13 Hand Analysis

4.13.1 Hand analysis procedure

1. Select Imaging from the Analyze toolbar to verify point typing.

2. Select ROI is from the Analyze toolbar to adjust ROIs. 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 should include the carpal bones, but not the ulna or radius.

3. Select the Move ROI tool or the Move Vertex tool to adjust the edges of the region of interest.

Icon Tool Description

Move ROI Move Vertex

Select to move the ROI edges. Do not move the lines unless they are obviously incorrect. Select to move the vertices of the ROI.

4. point typing unless the program made obvious errors. If you adjust point typing, select Results to view the new analysis results based on your changes.

5. 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 for additional Analysis information.

If necessary, select Points from the Analyze toolbar to adjust point typing. Do not adjust the

Bone Points

Neutral Points

Tissue Points

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4.14 Orthopedic Analysis

4.14.1 Basic Analysis Tools for Orthopedic

Orthopedic Analysis is done automatically. Select either Standard Gruen or Extended Gruen Zones. Set the default Gruen method in Tools/ User Options/ Analyze and select the Ortho Analysis Option.

Toggle between Standard and Extended Gruen zones from the ROIs screen.

Standard Extended

Verify that the ROIs and implant length are correctly identified. The following tools are available on the ROIs screen:

Click on the ROIs Tool to view the following options.

Icon Tool Description

Move / Size Gruen Ruler

Length

The Ruler icon allows the user to measure the implant length The Ruler provides a measurement value real time by clicking on the edge and moving to the user's choice of destination. Either edge of the ruler may be relocated for a measurement.

The Length icon provides the opportunity to modify the length of the implant. (The software automatically calculates a length based on the automated ruler measurement.) The Length feature also includes a Find button which prompts the software to search for the implant edges based upon the ruler position.

This option enables the selection and adjustment of a single Gruen zone. Edit the Top and Bottom points of the Implant

Edit the Length of the Implant

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It is recommended that the top of Gruen zones 1 and 7 align with the shoulder of the implant. Upon entering the ROI screen, the Gruen icon is selected and all ROIs are active. This allows the user to move all regions at the same time. However, the user has the option to move each zone individually, if desired.

4.15 Pediatric Analysis

Pediatric analysis is a purchased option. Reference data is available for U.S. and European populations. Reference data is limited to AP Spine, Femur and Total Body analysis. Z-scores and percentages are used to compare the pediatric patient to their peers. Pediatric patients have not yet reached their peak bone densities.

4.15.1 Pediatric Total Body Analysis

Pediatric Total Body will provide reference data for U.S. and European reference populations. The BMD of the head appears to dominate the Total Body BMD in children.

To enable the feature to omit the head ROI, select Tools / User Options / Analyze / Total Body

Analysis Options. Check the option box. Click OK.

Select Regions or Omit Region on DXA Report

To select regions or omit the head ROI on DXA reports, select Tools / User Options / Reports tab. Click on the Report Regions button.

Click on the Total Body tab.

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Highlight the desired region or TBLH (Total Body Less Head) option in the left

T Available window. (TBLH

indicates the head is omitted from the analysis.) Click on the Add button. The new selected region ROI will be added to the Selected list on the right.

Repeat the same steps to add the ROI region to the Composition Report.

Note the variable SD reference values for pediatrics are shown with tapered edges sin ce chil dren mature at different rates.

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4.15.2 Pediatric AP Spine and Femur Analysis

Pediatric AP Spine and Femur will provide reference data for U.S. and European reference populatio ns.

4.15.3 Pediatric Monitoring Tools

Pediatric Growth tools can be found under the Peds tab in the analysis screen. The software will provide information on Bone Size and Lean Body Mass Assessment.

Reporting the Growth Information In the Reports options, select the Ancillary check box to report the Growth Analysis data.

The Pediatric information must be entered in the Patient Information screen.

Bone Size Assessment

• Height for Age (Centile)

• BMC for Bone Area (Centile)

• Bone Area for Height (Cen tile)

Lean Mass Assessment

• LBM (lean body mass) for Height (Centile)

• BMC for LBM (Centile)

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GE Healthcare Lunar enCORE-based X-ray Bone Densitometer User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual