Lunar Series with enCORE v17 sw User Manual Rev 6 Jan 2020

Contents 1

Safety ... 25 Precautions for Standard Operating Procedures ... 25 Operator Safety ... 26 Personnel Monitors ... 26 X-Ray and Shutter Graphics ... 27 X-Ray Shutter ... 27 X-Ray Power Supply ... 27 Patient Safety ... 27 Mechanical Safety ... 29 Symbols ... 29 Sample Labels ... 30 Failsafe Circuit ... 35 X-Ray Shielding Requirements ... 35 Electrical Safety ... 36 Peripheral Configurations ... 36 Scatter Radiation ... 37

2

Product Information ... 39 Intended Use ... 39 Indications for Use ... 39 Cautions for DXA Determinations ... 41 Device Descriptions ... 42 Scanner Table Assembly ... 47 Training Information ... 50 Classifications ... 50 Installation and Operation ... 50 Software Installation ... 50 Features ... 51 Hardware Features ... 51 Software Features ... 51 Quality Assurance (QA) Features ... 52 User Information ... 52

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X-ray Bone Densitometer with enCORE v17 software - User Manual

Options ... 52 3

Daily Use ... 55 Daily Use ... 55 Archive Exam Files ... 55 Safe Use Guidelines ... 56 Emergency Stop Button ... 57 Test Emergency Stop Button ... 57 Clean Scanner Table Environment ... 57 Annual Maintenance ... 57 X-Ray Tube and Laser Assembly Maintenance ... 58

4

Quality Assurance (QA) ... 59 Daily Quality Assurance Procedure ... 59 Precision and Accuracy ... 60 QA Controls ... 61 QA Trend Reporting Options ... 61 Measure the Spine Phantom ... 63

5

Measurement and Analysis ... 67 Measurement: Overview and Warnings ... 67 Measurement Modes ... 68 Measurement Procedures: Overview ... 72 Select Existing Patient Record ... 72 Record New Patient Information ... 73 Select Measurement Site ... 75 Abort Measurement ... 75 OneVision ... 76 QuickView ... 77 Analysis Procedures: Overview ... 77 Select Image ... 77 Adjust Image ... 78 Advanced: Adjust ROIs ... 79 Advanced: Adjust Point Typing ... 79 Examine Results ... 80 OneScan ... 85 Turning OneScan On and Off ... 85

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X-ray Bone Densitometer with enCORE v17 software - User Manual

OneScan Measurement ... 85 AP Spine Measurement and Analysis ... 86 AP Spine Measurement ... 86 AP Spine Analysis ... 89 Femur/DualFemur Measurement and Analysis ... 91 Femur/DualFemur Measurement ... 91 Atypical Femur Fracture Measurement ... 93 Femur/DualFemur Analysis ... 96 Forearm Measurement and Analysis ... 110 Forearm Measurement ... 110 Forearm Analysis ... 113 Total Body Measurement and Analysis ... 114 Total Body Measurement ... 114 Total Body Analysis ... 116 Body Composition Measurement and Analysis ... 121 Body Composition Measurement ... 122 Body Composition Analysis ... 124 Sarcopenia (Muscle Loss with Aging) ... 139 Lateral Spine Measurement and Analysis ... 143 Lateral Spine Measurement ... 143 Lateral Spine Analysis ... 146 LVA Morphometry Measurement and Analysis ... 147 LVA Morphometry Measurement ... 147 LVA Morphometry Analysis ... 149 LVA Spine Geometry Measurement and Analysis ... 155 LVA Spine Geometry Measurement ... 155 LVA Spine Geometry Analysis ... 157 APVA Morphometry Measurement and Analysis ... 158 APVA Morphometry Measurement ... 158 APVA Morphometry Analysis ... 160 APVA Spine Geometry Measurement and Analysis ... 160 APVA Spine Geometry Measurement ... 160 APVA Spine Geometry Analysis ... 162 Dual VA Measurement and Analysis ... 163

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X-ray Bone Densitometer with enCORE v17 software - User Manual

Pediatric Measurement and Analysis ... 163 Pediatric Measurement ... 164 Pediatric Analysis ... 165 Hand Measurement and Analysis ... 167 Hand Measurement ... 167 Hand Analysis ... 169 Orthopedic Hip Measurement and Analysis ... 170 Orthopedic Hip Measurement ... 170 Orthopedic Hip Analysis ... 172 Orthopedic Knee Measurement and Analysis ... 174 Orthopedic Knee Measurement ... 174 Orthopedic Knee Analysis ... 176 Small Animal Measurement and Analysis ... 177 Small Animal Measurement ... 177 Small Animal Analysis ... 178 Custom Analysis ... 180 Custom Analysis Toolbar ... 180 Precision Calculator ... 181 Precision Wizard ... 182 Custom Reference Population ... 182 Create a New Reference Population ... 183 Edit a Custom Reference Population ... 183 Delete a Custom Reference Population ... 183 ScanCheck ... 183 ScanCheck Checklist ... 184 Adjusting ScanCheck Thresholds ... 184 6

Directory Management ... 187 Move Scans ... 187 Copy Exam Files ... 187 Email Image Files ... 187 Edit Patients or Exams ... 188 Delete Patients, Exams, or Images ... 188 Change Image Type ... 189 Batch Exam File Operations ... 189

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X-ray Bone Densitometer with enCORE v17 software - User Manual

7

Reporting ... 191 Reports ... 191 DXA Reports ... 191 Composer Reports ... 192 Report Center ... 193 Create a Report ... 193 Select Additional Reports ... 195 Change an Assessment for a Report ... 196 Configure Rules to Automatically Select Reports ... 197 Optimizing the Report Center ... 198 Style Sheets ... 199 Create a New Style Sheet ... 200 Subreports ... 201 Create a New Subreport ... 201 Add a Subreport to a Style Sheet ... 201 Configure a Subreport to Appear Only Under Certain Conditions ... 202 Assessment Editor ... 202 Composer Database ... 205 Create a New Database ... 205 Change the Active Database ... 206 Practice Management Tools ... 206 Available Reports ... 206 Add a Query ... 209 Edit a Query ... 211 Delete a Query ... 211 BMD Site/Region Filters ... 211 History Catalog ... 212

8

Database Maintenance ... 213 Database Maintenance ... 213 Compress Database ... 213 Delete Database ... 214 Edit Database ... 214 Export Database ... 216 New Database ... 216

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X-ray Bone Densitometer with enCORE v17 software - User Manual

Archive ... 217 Restore Backup ... 218 Rebuild Database ... 218 Import Entire Databases ... 219 Import Database Manually ... 220 Supported Import Options ... 220 Task Scheduler ... 221 SQL Server Database Interface ... 221 External USB Hard Drive ... 222 9

Troubleshooting ... 225 Troubleshooting ... 225

10 Screens and Toolbars ... 227 Screens and Toolbars ... 227 Using Screens ... 227 Using Toolbars ... 227 Patient Block ... 227 Help Text ... 227 Main Screen ... 227 Common Toolbar ... 229 New Measurement Screen ... 229 New Measurement Toolbar ... 230 Analyze When Done Option ... 230 Home Scanner Arm ... 230 Park Scanner ... 231 Analyze Screen ... 231 Analyze Toolbar ... 231 Results Tabs ... 232 Directory Screen ... 233 Search ... 233 Directory Toolbar ... 234 Patient List and Exam List ... 234 Database Sidebar ... 235 Quality Assurance Screen ... 235 Quality Assurance Toolbar ... 236

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X-ray Bone Densitometer with enCORE v17 software - User Manual

System Status ... 236 Options ... 236 User Options ... 236 Connectivity Options ... 250 Error Log ... 252 11 Security ... 255 Introduction ... 255 Security Features ... 255 Access Controls ... 255 Windows User Account Requirements ... 256 Application Security Settings ... 256 Create Windows User Groups ... 256 Add Users to Windows Groups ... 257 Configure User Accounts for Electronic Signatures ... 257 Configure Application Functions Available to Groups ... 257 Authentication ... 258 Authorization ... 259 Audit Controls ... 259 Malicious Software Protection ... 261 Workstation Security ... 263 Data Protection ... 263 Security Operations ... 264 Network Security ... 264 Business Continuity ... 264 Media Access Control Points ... 264 Remote Service ... 265 Network Interface Specifications and Risk Management ... 266 Using the GEHC Product Security Database ... 268 A

Specifications ... 271 Systems Specifications ... 271 Physical Specifications ... 272 Operational Environment Specifications ... 273 Storage and Transport Environment Specifications ... 276 Space Requirements ... 276

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X-ray Bone Densitometer with enCORE v17 software - User Manual

Leakage Current ... 279 Input Power ... 279 Fuse Capability ... 280 Collimator Specifications ... 280 X-Ray Generator Technical Specifications ... 281 X-Ray Tube Head Assembly ... 289 X-Ray Tube Technical Information ... 290 Anode Heating/Cooling Curves ... 293 Filament Emission Characteristics ... 295 X-Ray Tube Assembly Heating/Cooling Curves ... 296 Maximum Scan Area (Long X Transverse) ... 297 Scatter Radiation Diagrams ... 298 Current and Typical Dose Tables ... 308 IEC and UL/CSA Certification ... 321 Electromagnetic Interference ... 321 Electromagnetic Compatibility (EMC) Performance ... 321 Minimum PC Requirements ... 324 B

Reference Data ... 329 enCORE Reference Data ... 329 Using the Reference Population Comparison ... 329 Choosing Reference Population Options ... 330 Configuring the Comparison to Reference Graph ... 331 Reference Data Populations ... 332

C

Adult Reference Data ... 339 Bone Mineral Density (BMD) ... 339 %Young Adult ... 340 %Age-Matched ... 341 %Age-Matched: Weight Adjustment ... 342 %Age-Matched Ethnicity Adjustment ... 343 %Age-Matched Nationality Reference Database ... 344 Reference Graph: Female and Male ... 344 Reference Graphs: Other Sites ... 345

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X-ray Bone Densitometer with enCORE v17 software - User Manual

Bone Mineral Density Reference Populations ... 346 Comparison to Young Adult ... 347 Comparison to Age-Matched ... 347 Effect of Postmenopausal Years ... 350 Reference Population Database ... 350 Age Adjustment ... 350 Weight Adjustment ... 358 Lateral Spine Morphometry Reference Values ... 359 Hip Axis Length ... 362 References ... 363 D

Pediatric Reference Data ... 371 Bone Mineral Density (BMD) ... 371 %Age-Matched ... 372 %Age-Matched Ethnicity Adjustment ... 373 %Age-Matched Nationality Reference Database ... 374 Reference Graph: Female and Male ... 374 Reference Graphs: Other Sites ... 375 Bone Mineral Density Reference Populations ... 376 Comparison to Age-Matched ... 377 Reference Population Database ... 380 Age Adjustment ... 380 Growth Indices ... 394 References ... 401

E

Body Composition Reference Data ... 403 Introduction ... 403 Android and Gynoid Regions of Interest ... 403 Reference Populations that Support Total Body Composition Reference Data ... 404 Body Composition Reference Values for Female Percent Fat ... 404 Body Composition Reference Data for Male Percent Fat ... 406 Body Composition Percent Fat Reference Data ... 406 References ... 409

F

USA (NHANES 1999-2004) Total Body Reference Data ... 411 Introduction ... 411

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X-ray Bone Densitometer with enCORE v17 software - User Manual

NHANES 1999-2004 Reference Population ... 414 G

AFF Phantom Study Results ... 457 Introduction ... 457 Accuracy of Beak Size ... 457 Reproducibility of Beak Size ... 458 Beak Size Dependence on Positioning ... 458

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X-ray Bone Densitometer with enCORE v17 software - User Manual

Contact Information www.gehealthcare.com

Headquarters/Legal Manufacturer

Germany

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC 通用电气医疗系统超声及基础医 疗诊断有限公司

GE Medical Systems SCS 283 rue de la Minière 78530 BUC, France

Street address:

Beethoven Str. 239 D-42655 Solingen Germany Phone: +49–212–2802–0 Fax: +49–212–2802–390

3030 Ohmeda Dr. Madison, WI 53718 USA Mailing address:

P.O. Box 7550 Madison, WI 53707-7550 USA Phone: +1 (800) 437–1171 China

France

Asia/Pacific

No. 19 Changjiang Road

24 Avenue de l'Europe- CS 20 529

4–7–127 Asahigaoka

Wuxi, Jiangsu, 214028

78 457 VELIZY

Hino-shi, Tokyo 191–8503

P.R.C.

Phone: +33–1–34–49–5365

Japan

Phone: +86–510–85225888

Fax: +33–1–34–49–5406

Phone: +81–42–585–5111

Fax: +86–510–85226688

Fax: +81–42–585–3077

Physical Manufacturer Address

Turkey

GE MEDICAL SYSTEMS MONTERREY, MEXICO S.A. DE C.V.

GE Medical Systems Türkiye Ltd. Şti

Calle España No. 300, Parque Industrial Huinalá, Apodaca,

Esentepe Mah. Harman Sok. No: 8 34394 Şişli İstanbul Türkiye

Nuevo Leon, Mexico C.P. 66645

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC, 通用电气医疗系统超声及基础医疗诊断有限公司 a General Electric company, doing business as GE Healthcare/GE Santé au Québec.

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X-ray Bone Densitometer with enCORE v17 software - User Manual

Preface

This manual provides instructions for operating the software and scan table, safety and maintenance information, and technical specifications for your bone densitometer. 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 Ultrasound & Primary Care Diagnostics LLC. Any reproduction, photocopying and recording in whole or part is prohibited. Any information contained herein shall not be disclosed to any company viewed as a competitor to GE Medical Systems Ultrasound & Primary Care Diagnostics LLC. GE Medical Systems Ultrasound & Primary Care Diagnostics LLC 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. The information contained in the manual is confidential and proprietary to General Electric. This information is provided only to authorized representatives of GE Medical Systems Ultrasound & Primary Care Diagnostics LLC customers solely for the purpose of facilitating the use of GE Medical Systems Ultrasound & Primary Care Diagnostics LLC products. No information contained herein may be disclosed to any unauthorized person for any purpose whatsoever without prior written consent of GE Medical Systems Ultrasound & Primary Care Diagnostics LLC. Copyright © 1999-2020 GE Medical Systems Ultrasound & Primary Care Diagnostics LLC, Madison, Wisconsin. All rights reserved. First year of CE Mark: 2007 Read this manual thoroughly before using the system or attempting to service any components. Unauthorized service may void system warranties or service contracts. Consult the GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Customer Service Department before attempting any service: 800-437-1171 (U.S.A). 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). Lunar iDXA, Prodigy, DPX, and CoreScan are trademarks or registered trademarks of General Electric Company. All other product and brand names are registered trademarks or trademarks of their respective companies. The devices for which this manual is used may also be marketed under the following names: Lunar iDXA* Series iDXA Lunar iDXA

Lunar Prodigy* Series Prodigy Advance Prodigy Primo Prodigy Primo Compact Prodigy Pro Prodigy Pro Compact

Lunar DPX* Series DPX-NT * are trademarks of General Electric Company.

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X-ray Bone Densitometer with enCORE v17 software - User Manual

Throughout this manual the term “image” is used to indicate a Dual-energy X-ray Absorptiometry (DXA) image, which is constructed from low-energy and high-energy signals. Depending on the intended use, when a DXA image is displayed for a quantitative application such as Spine or Femur BMD, the image is labeled “Image Not for Diagnosis.” For applications such as Lateral Vertebral Assessment (LVA) running on Prodigy or iDXA, the image is labeled “Image for Spine Morphometry Assessment Only.” For applications such as Atypical Femur Fracture (AFF) running on Prodigy or iDXA, the image is labeled “Image for atypical femur fracture assessment only”. The simple term “image” is used throughout the manual for readability.

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X-ray Bone Densitometer with enCORE v17 software - User Manual

License and Warranty Information

Please carefully read the following terms and conditions before installing or operating the GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Software ("Software"). By installing or using the Software in Your GE Medical Systems Ultrasound & Primary Care Diagnostics LLC 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 Ultrasound & Primary Care Diagnostics LLC. The Software has been provided to You for use on a specific GE Medical Systems Ultrasound & Primary Care Diagnostics LLC 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 Ultrasound & Primary Care Diagnostics LLC reserves any rights not expressly granted to You. This license is non-exclusive and a non-transferable license to use the GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Software. Re-distribution of Software or any documentation provided to You by GE Medical Systems Ultrasound & Primary Care Diagnostics LLC 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 Ultrasound & Primary Care Diagnostics LLC 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 Ultrasound & Primary Care Diagnostics LLC 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 Ultrasound & Primary Care Diagnostics LLC 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 Ultrasound & Primary Care Diagnostics LLC 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 Ultrasound & Primary Care Diagnostics LLC 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 Ultrasound & Primary Care Diagnostics LLC. GE Medical Systems Ultrasound & Primary Care Diagnostics LLC 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 Ultrasound & Primary Care Diagnostics LLC product or use the Software. IN NO EVENT SHALL GE Medical Systems Ultrasound & Primary Care Diagnostics LLC 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 SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC SHALL HAVE NO RESPONSIBILITY TO REPLACE

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X-ray Bone Densitometer with enCORE v17 software - User Manual

THE SOFTWARE. GE Medical Systems Ultrasound & Primary Care Diagnostics LLC will consider this warranty to be void if You fail to comply with the terms in the Software License Agreement.

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X-ray Bone Densitometer with enCORE v17 software - User Manual

6. TITLE. Title, ownership rights, and intellectual property rights in the Software shall remain with GE Medical Systems Ultrasound & Primary Care Diagnostics LLC. 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.

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X-ray Bone Densitometer with enCORE v17 software - User Manual

Registration

Government health departments can require medical facilities to register diagnostic x-ray equipment. Many municipal and state health agencies require medical health facilities to employ certified radiologic technologists to operate diagnostic x-ray devices. Contact your local regulatory authorities or GE representative for registration guidelines and regulation compliance.

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X-ray Bone Densitometer with enCORE v17 software - User Manual

Disposal of Materials

The scanner contains lead (for x-ray shielding) and one of the following: sodium iodide, cadmium telluride, Lutetium Yttrium Silicon Dioxide (LYSO), or cadmium zinc telluride (used for x-ray detection).

WEEE Label

This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment. If you contract with GE Medical Systems Ultrasound & Primary Care Diagnostics LLC for the disposal of your scanner, GE Medical Systems Ultrasound & Primary Care Diagnostics LLC will properly dispose of these materials. If you choose to dispose of your scanner yourself, both substances must be disposed of in accordance with local regulations. Contact your local GE representative for WEEE information.

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X-ray Bone Densitometer with enCORE v17 software - User Manual

FDA Certified Components (USA Only) Lunar iDXA Series The following table gives components certified to the FDA for use with Lunar iDXA series scanners. The tables are updated periodically. Contact GE Healthcare for a current listing of compatible components.

Component

Description

GE Model

Tube head assembly

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC iDXA Series X-Ray Tube Head Assembly

40782

X-ray controller

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC iDXA Series X-ray Controller

41718

Collimator

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC iDXA Series Collimator Assembly

42129

PRODIGY Series 301000 and higher The following tables give components certified to the FDA for use with Prodigy series scanners. The tables are updated periodically. Contact GE Healthcare for a current listing of compatible components.

Component

Description

GE Model

X-ray controller

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC single board controller

41170

High voltage power supplies

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Model: 2907

7681 7681

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Model: SBD40PN280X2890 or SBD40PN280X4445

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Tube head assembly

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC X-Ray Tube Head Assembly

45645

Collimator

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC PRODIGY Collimator Assembly

8915

X-ray Bone Densitometer with enCORE v17 software - User Manual