GE Healthcare X-ray Bone Densitometer with enCORE v17 Software User Manual

GE Healthcare

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

This manual supports the following products: Lunar iDXA Series, Lunar Prodigy Series, Lunar DPX Series

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

LU43616EN-2EN Revision 19 (September 2017)

© 2017 GE Healthcare

1	Safety ............................................................................................................	25
	Precautions for Standard Operating Procedures........................................	25
	Operator Safety.............................................................................................	26
	Personnel Monitors .....................................................................................	26
	X-Ray and Shutter Graphics .......................................................................	27
	X-Ray Shutter...............................................................................................	27
	X-Ray Power Supply ....................................................................................	27
	Patient Safety ................................................................................................	27
	Mechanical Safety.........................................................................................	29
	Symbols .........................................................................................................	29
	Sample Labels ...............................................................................................	30
	Failsafe Circuit...............................................................................................	35
	X-Ray Shielding Requirements .....................................................................	35
	Electrical Safety.............................................................................................	36
	Peripheral Configurations...........................................................................	36
	Scatter Radiation ..........................................................................................	37
2	Product Information ....................................................................................	39
	Intended Use .................................................................................................	39
	Indications for Use ........................................................................................	39
	Cautions for DXA Determinations ................................................................	41
	Device Descriptions ......................................................................................	42
	Scanner Table Assembly...............................................................................	47
	Training Information .....................................................................................	50
	Classifications................................................................................................	50
	Installation and Operation............................................................................	50
	Software Installation.....................................................................................	50
	Features.........................................................................................................	51
	Hardware Features .....................................................................................	51
	Software Features .......................................................................................	51
	Quality Assurance (QA) Features ................................................................	52
	User Information .........................................................................................	52
	Options.........................................................................................................	52
3	Daily Use .......................................................................................................	55

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

	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
	OneScan Measurement ..............................................................................	85
	AP Spine Measurement and Analysis ..........................................................	86

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

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
Pediatric Measurement and Analysis ........................................................	163
Pediatric Measurement.............................................................................	164

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

	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
7	Reporting ....................................................................................................	191
	Reports ........................................................................................................	191

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

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
Archive .........................................................................................................	217
Restore Backup ...........................................................................................	218

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

	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
	System Status............................................................................................	236
	Options ........................................................................................................	236

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

	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
	Leakage Current..........................................................................................	279
	Input Power .................................................................................................	279

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

	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................................................................	307
	IEC and UL/CSA Certification......................................................................	320
	Electromagnetic Interference ....................................................................	320
	Electromagnetic Compatibility (EMC) Performance ..................................	320
	EMC Environment and Guidance..............................................................	321
	Declarations of Immunity and Emissions ................................................	321
	Minimum PC Requirements ......................................................................	323
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
	Bone Mineral Density Reference Populations ...........................................	346
	Comparison to Young Adult......................................................................	347

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

	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
	NHANES 1999-2004 Reference Population ...............................................	414
G	AFF Phantom Study Results......................................................................	457

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

Introduction.................................................................................................	457
Accuracy of Beak Size.................................................................................	457
Reproducibility of Beak Size........................................................................	458
Beak Size Dependence on Positioning.......................................................	458

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

Contact Information

www.gehealthcare.com

	Headquarters/Legal	Germany
	Manufacturer	Beethoven Str. 239
	GE Medical Systems Ultrasound &
		GE Medical Systems SCS
	Primary Care Diagnostics, LLC.	D-42655 Solingen
		283 rue de la Minière
	Street address:	Germany
		78530 BUC, France
	3030 Ohmeda Dr.	Phone: [phone]
	Madison, WI 53718	Fax: [phone]
	USA
	Mailing address:
	P.O. Box 7550
	Madison, WI 53707-7550
	USA
	Phone: [phone]

China	France	Asia/Pacific
No. 19 Changjiang Road	24 Avenue de l'EuropeCS 20 529	4–7–127 Asahigaoka
Wuxi, Jiangsu, 214028	78 457 VELIZY	Hino-shi, Tokyo 191–8503
P.R.C.	Phone: [phone]	Japan
Phone: [phone]	Fax: [phone]	Phone: [phone]
Fax: [phone]		Fax: [phone]

	Physical Manufacturer Address	Turkey
	GE MEDICAL SYSTEMS MONTERREY,	GE Medical Systems Türkiye Ltd. Şti
	MEXICO S.A. DE C.V.	Esentepe Mah. Harman Sok. No: 8
	Calle España No300, Parque
		34394 Şişli İstanbul Türkiye
	Industrial Huinalá, Apocada
	Nuevo Leon CP 66645 MEXICO

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, a General Electric company, doing business as GE Healthcare/GE Santé au Québec.

13	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 Healthcare.

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 Healthcare.

GE Healthcare 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 Healthcare customers solely for the purpose of facilitating the use of GE Healthcare products. No information contained herein may be disclosed to any unauthorized person for any purpose whatsoever without prior written consent of GE Healthcare.

Copyright © 2007-2017

GE Healthcare, 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 Healthcare 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

iDXA Advance iDXA Pro iDXA Forma Lunar iDXA

Lunar Prodigy* Series

Prodigy Advance

Prodigy Advance Compact

Prodigy Primo

Prodigy Primo Compact

Prodigy Pro

Prodigy Pro Compact

Prodigy Forma

Primo

Primo Compact

Prodigy

Prodigy Compact

Lunar DPX* Series

DPX-NT

DPX-MD+

DPX Bravo

DPX Duo

DPX Pro MD+ Bravo Duo

* are trademarks of General Electric Company.

14	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.

15	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 Healthcare Software ("Software"). By installing or using the Software in Your GE Healthcare 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 Healthcare.

The Software has been provided to You for use on a specific GE Healthcare 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 Healthcare reserves any rights not expressly granted to You. This license is non-exclusive and a non-transferable license to use the GE Healthcare Software. Re-distribution of Software or any documentation provided to You by GE Healthcare 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 Healthcare may update or revise the Software, and in so doing incur no obligation to furnish such updates to You under this License. GE Healthcare has no obligation to improve, update or support the Software in the future.

(c)In the event the instrument or product designated for the Software is sold or otherwise transferred to a third party, that party is not authorized to use the Software unless they first pay to GE Healthcare the applicable license fee and agree to the terms and conditions of a Software License Agreement. Upon transfer of the Software or any copy thereof, the License granted hereunder shall terminate immediately.

3. TERM AND TERMINATION.

This License is effective until terminated. This License will terminate immediately without notice from GE Healthcare 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 Healthcare warrants that, to the best of our knowledge, the software provided with this License will perform as described in the product's operator's manual and the technical specification for this Software. This limited warranty is contingent upon proper use of the Software and does not cover any Software which has been modified, subjected to malicious logic, unusual physical or electrical stress, or used on computer equipment not specified by GE Healthcare.

GE Healthcare does not warrant that the functions contained in this Software will meet your requirements, or that the operation of the Software will be uninterrupted or errorfree. Statements made about this Software do not constitute warranties and shall not be relied upon by You in deciding whether to purchase the GE Healthcare product or use the Software. IN NO EVENT SHALL GE Healthcare BE LIABLE TO YOU FOR ANY DAMAGES ARISING OUT OF THE USE OR INABILITY TO USE SUCH SOFTWARE.

THE SOLE AND EXCLUSIVE REMEDY IN THE EVENT OF DEFECT IS EXPRESSLY LIMITED TO THE REPLACEMENT OF THE SOFTWARE PROVIDED. IF FAILURE OF THE SOFTWARE HAS RESULTED FROM ACCIDENT OR ABUSE, GE HEALTHCARE SHALL HAVE NO RESPONSIBILITY TO REPLACE THE SOFTWARE.

GE Healthcare will consider this warranty to be void if You fail to comply with the terms in the Software License Agreement.

16	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 Healthcare. 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.

17	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.

18	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 Healthcare for the disposal of your scanner, GE Healthcare will properly dispose of these materials. If you choose to dispose of your scanner yourself, both substances must be disposed of in accordance with local regulations. Contact your local GE representative for WEEE information.

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

FDA Certified Components

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	GE Medical Systems Ultrasound &	40782
assembly	Primary Care Diagnostics, LLC iDXA
	Series X-Ray Tube Head Assembly
X-ray controller	GE Medical Systems Ultrasound &	41718
	Primary Care Diagnostics, LLC iDXA
	Series X-ray Controller
Collimator	GE Medical Systems Ultrasound &	42129
	Primary Care Diagnostics, LLC iDXA
	Series Collimator Assembly

PRODIGY Advance 301000 and higher, PRODIGY 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 &	41170
	Primary Care Diagnostics, LLC single
	board controller
High voltage power	GE Medical Systems Ultrasound &	7681
supplies	Primary Care Diagnostics, LLC Model:	7681
	2907
	GE Medical Systems Ultrasound
	& Primary Care Diagnostics, LLC
	Model: SBD40PN280X2890 or
	SBD40PN280X4445
Tube head	GE Medical Systems Ultrasound &	8743 or 45645
assembly	Primary Care Diagnostics, LLC X-Ray
	Tube Head Assembly
Collimator	GE Medical Systems Ultrasound	8915
	& Primary Care Diagnostics, LLC
	PRODIGY Collimator Assembly

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

PRODIGY Advance 40000-141999, PRODIGY 13000-13999

Component	Description	GE Model
X-ray controller	GE Medical Systems Ultrasound &	7635
	Primary Care Diagnostics, LLC single
	board controller
High voltage power	GE Medical Systems Ultrasound &	7681
supplies	Primary Care Diagnostics, LLC Model	7681
	2907
	GE Medical Systems Ultrasound
	& Primary Care Diagnostics, LLC
	Model SBD40PN280X2890 or
	SBD40PN280X4445
Tube head	GE Medical Systems Ultrasound &	8743 or 45645
assembly	Primary Care Diagnostics, LLC X-Ray
	Tube Head Assembly
Collimator	GE Medical Systems Ultrasound &	8915
	Primary Care Diagnostics, LLC Prodigy
	Collimator Assembly

DPX-NT/PRO/MD+/72000 and higher/90000 and higher

The following give components certified to the FDA for use with DPX-NT/PRO/MD+ 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 &	7634
	Primary Care Diagnostics, LLC single
	board controller
High voltage power	GE Medical Systems Ultrasound &	7681
supplies	Primary Care Diagnostics, LLC Model	7681
	2907
	GE Medical Systems Ultrasound
	& Primary Care Diagnostics, LLC
	Model SBD40PN280X2890 or
	SBD40PN280X4445

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

Component	Description	GE Model
Tube head assembly	GE Medical Systems Ultrasound &	8548 or 45649
	Primary Care Diagnostics, LLC X-Ray
	Tube Head Assembly
Collimator	GE Medical Systems Ultrasound &	7767
	Primary Care Diagnostics, LLC DEXA
	Collimator Assembly

DPX Duo, DPX Bravo

Component	Description	GE Model
X-ray controller	GE Medical Systems Ultrasound & Primary	41500
	Care Diagnostics, LLC single board controller
High voltage power	GE Medical Systems Ultrasound &	7681
supplies	Primary Care Diagnostics, LLC Model
	SBD40PN280X2890 or SBD40PN280X4445
Tube head assembly	GE Medical Systems Ultrasound & Primary	8548 or 45649
	Care Diagnostics, LLC X-Ray Tube Head
	Assembly
Collimator	GE Medical Systems Ultrasound & Primary	7767
	Care Diagnostics, LLC DEXA Collimator
	Assembly

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

Operator Profile

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

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

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

1

Safety

Precautions for Standard Operating Procedures

Use of controls or adjustments or performance of the procedures other than those specified herein may result in hazardous (laser or x-ray) radiation exposure.

1.Do not attempt to operate the x-ray bone densitometer without first reading this manual.

2.Do not remove the assembly panels or attempt any repairs without prior instructions from authorized personnel.

3.Perform the Quality Assurance procedure each morning. If any test fails, check the position of the calibration block and rerun the QA procedure. If a test fails again, contact GE Support. Also, call GE Support if more than two failures occur in a one-week period. If the room temperature changes more than 5°C during the day, perform another daily QA.

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

5.Remain in visual contact with the patient while a scan is in progress. Ensure that the patient does not move during the measurement. Minimize the amount of time the patient lies flat on the scan table.

6.Restrict access to the room to authorized personnel.

7.Do not attempt to service any of the system's electrical components while the x-ray bone densitometer is turned ON. High voltage is used to produce x-rays.

8.Radiation safety information is located within this manual you received with your system. Review this information before operation.

9.To stop the x-ray bone densitometer in an emergency, press the emergency stop button on the scan arm. DO NOT use the emergency stop button to routinely abort a scan.

10.Immediately remove any fluids spilled on the pad or any surface of table.

11.All surfaces should be cleaned to meet site's guidelines for handling blood and body fluids. Pad material may be damaged by certain chemicals. Use appropriate hospital grade disinfectant (for example: Cidex®, HB Quat, Precise®, PDI) followed by mild detergent.

12.Do not generate x-rays through the use of remote applications.

13.Protect the computer against malicious logic and unauthorized network access. Only allow authorized user access. Prevent virus attacks by using

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

Safety

firewalls, anti-virus software and software patch updates. Contact your local GE representative for more information.

14.DPX Duo: Extend the step the full distance to provide maximum surface area for the patient to get on and off the table without risk of injury.

15.DPX Duo: Do not place an excessive load on foot rest stirrup (maximum load is 60 pounds), drawers (maximum load is 100 pounds), or leg extension table (maximum load is 300 pounds).

16.DPX Duo: Do not sit on leg extension table.

Operator Safety

Because the DXA has two control points (PC and front panel), the operator should visually ensure that no person is near moving parts, pinch points, or the x-ray beam before starting a scan. The operator must understand the use of the emergency stop button on the front panel. See Emergency Stop Button (57).

DPX NT/MD, DPX Duo/Bravo, and Prodigy scanners: To avoid scatter radiation, the operator should remain at least 3 feet (1 meter) away from the center of the scanner.

iDXA scanners: To avoid scatter radiation, the operator should remain at least 6 feet (2 meters) away from the center of the scanner.

Maximizing the distance from the patient will decrease the operator’s exposure to scatter radiation; however, the operator should maintain visual or voice contact with the patient at all times. Optional protective equipment will further reduce the operator’s exposure to scatter radiation.

Personnel Monitors

Personnel monitors are not necessary to operate the scanner.

It is not likely that you can receive more than 25% of the maximum permissible x-ray dose from the scanner. However, some facilities choose to use personnel monitors. Refer to your city, county or state Health Department or Radiation Safety Officer

for your facility's policy.

Film badges and thermal luminescent dosimeter (TLD) badges are obtained from a supplier accredited by the National Voluntary Laboratory Accreditation Program for personnel dosimetry processing.

The following is a sample situation for a clinic measuring an AP spine and Dual Femur on 5 subjects per day with an exposure rate of 0.18mR/hr at a distance of 2 meters estimated from the iDXA isodose curves.

Sample Calculation for Estimated Exposure per Year from Scatter with iDXA Densitometer

Scan Type	Mode	Average	Scan	Equivalent
		Scans/Day	Time/Day	2.5 mA Scan
			(sec/day)	Time/day
				(sec/day)
AP Spine	Standard	5	260	260
Dual Femur	Standard	5	535	535
2.5 mA Scan Time per Day (sec)				795
2.5 mA Scan Time per Day (hours)				0.221

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

Safety

Scan Type	Mode		Average	Scan	Equivalent
			Scans/Day	Time/Day	2.5 mA Scan
				(sec/day)	Time/day
					(sec/day)
2.5 mA Scan Time per Week (hours)					1.11
2.5 mA Scan Time per Year (hours)					57.5
2.5 mA Exposure from Isodose Plots (mR/hr)					0.18
Total Exposure for 1 Year (mR)					10.3
Total Absorbed Dose for 1 Year (mRad) 0.92 Rad/R					9.5

X-Ray and Shutter Graphics

During a measurement or Quality Assurance procedure, x-ray and shutter graphics are shown on the computer monitor. The graphics are green to indicate x-rays are off and the shutter is closed, and yellow to indicate x-rays are on and the shutter is open.

X-rays off and shutter closed (green)

X-rays on and shutter open (yellow)

X-Ray Shutter

When power to the scanner is interrupted during a measurement or Quality Assurance procedure, the shutter closes and the x-ray tube stops generating x-radiation.

X-Ray Power Supply

The x-ray tube assembly uses high voltage to generate x-rays. DO NOT touch internal components. DO NOT attempt to service internal components.

Patient Safety

Pinch Points

This label identifies the location of possible pinch points.

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

Safety

When the scanner arm is in motion, make sure possible pinch point areas are clear at all times. Patient limbs must remain inside the boundaries of the table top. A pinch point is possible between the scanner arm and table.

Laser Safety

DO NOT STARE INTO THE LASER BEAM during patient positioning and Quality Assurance procedures. This label is located under the scanner arm and shows the location of the laser aperture:

The laser aperture is located on the underside of the scanner arm, facing the patient. Keep the laser aperture away from the patient’s eyes during patient positioning.

Radiation Safety

X-ray exposure: The system makes radiation when electric voltage is supplied to, and current flows through, the x-ray tube. During a measurement, the shutter opens to let a beam of radiation pass through the scanner table and patient.

For iDXA systems, the nominal radiation field at the scanner table top is 18.4 mm x 3.3 mm.

For Prodigy systems, the nominal radiation field at the scanner table top is 19.5 mm x 3.4 mm.

For DPX systems, the nominal radiation field at the scanner table top is 2 mm.

Lead oxide shielding surrounds the x-ray tube insert inside the tube housing assembly and reduces radiation levels around the scanner table.

Leakage radiation: < 0.4 mR/hr at 1 meter.

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

Safety

Skin Entrance Dose

Refer to Current and Typical Dose Tables (307) for irradiation times and skin entrance doses. A Victoreen model 530 Precision Electrometer/Dosemeter with a Model 660-5 Ion Chamber was used to measure the X-ray entrance dose.

Mechanical Safety

The scanner arm moves down the entire length of the scanner table. Make sure the patient does not interfere with the movement of the scanner arm to prevent possible injury. In addition, make sure that there are no objects behind the scanner table that might obstruct movement of the scanner arm.

iDXA scanners: Weight applied to the scan table bed must not exceed 204 kg (450 lb).

DPX NT/MD+ scanners: Weight applied to the scan table bed must not exceed 136 kg (300 lb).

DPX Duo/Bravo and Prodigy scanners: Weight applied to the scan table bed or footstep (DPX Duo only) must not exceed 159 kg (350 lb).

Symbols

Symbol	Name	Description
	Electronic Instructions	Symbol indicating that the Instructions for Use
	for Use	are supplied in electronic form
	Emergency Stop	Shows the location of the emergency stop
		button
or
	Focal Point	Symbol from EN60417-1, 5327
	Functional Earth	Shows location of Functional Earth terminal
	Laser On	Shows the location of the Laser On indicator .
	Permanent Filtration	Symbol from EN60417-1, 5381

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Safety

Symbol	Name	Description
	Power Off	Shows the switch position for Power Off
	Power On	Shows the location of the Power On indicator
		and the switch position for Power On
	Protective Earth	Shows location of Protective Earth terminal
	Refer to Instruction	Alerts the user that the User Manual contains
	Manual	important safety information
	Shutter Open	Shows the location of the Shutter Open
		indicator
	Tube Insert	Symbol from EN60417-1, 5337
	Type B Equipment	Shows that the scanner has Type B protection
		against electrical shock
	Warning	Shows important safety warnings, such as the
		location of pinch points
	X-ray On	Shows the location of the X-ray On indicator
	X-ray Source	Symbol from EN60417-1, 5338

Sample Labels

Actual label appearance may vary from the samples displayed in this section.

For labels showing certification to 21 USCFR Subchapter J , the month in the Manufactured field is translated below.

English	Translation	English	Translation
	January		July
	February		August

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