GE Healthc Healthcare are
Lunar enCORE Safety Sa fety and and Sp Spec ecifica ificatio tion n Ma Manu nual al Rev 3 - Part number: number: LU43618EN 5/2009 GE Medical Medical Systems LUNAR LU NAR Contact Numbers Numbers
Headquarters GE Medical Systems Lunar 3030 Ohmeda Ohmeda Dr. Madison, Madison, WI 53718 USA +1 (800) 437-1171
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www.gehealthcare.com
DPX Series Series Prodigy Prodigy Series iDXA
YZB/US YZB/USA A 2099 SFDA(I)200 SFDA(I)200 23301115 YZB/US YZB/USA A 0509 SFDA(I)200 SFDA(I)200 43301375 YZB/US YZB/USA A 1104-2007 SFDA(I)200 SFDA(I)200 73302084
GE Medical Medical Systems Systems LUNAR LUNAR recommends recommends viewing viewing theinstructions theinstructions for navigating theLunar iDXA,PRODIGY™, PRODIGY™ Advance, Advance, PRODIGY™ Primo,PRODIGY™ Pro, DPX™ NT/Pro/MD+/Duo/Bravo™ NT/Pro/MD+/Duo/Bravo™ Safety Safety Information Information and Technical Technical Specif Specificat ications ions before before proceedi ceeding ng through through theonline theonline guidefor thefirsttime thefirsttime..
Tab able le of Co Cont nten ents ts I ntr oduction Sear ch Licens e and War r a nty I nfo r ma tion Gener al Pr odu ct I n for mation Training Training Information Information Cautions for DEXAD DEXADe eter minatio ns Pr ecautions fo r Standa r d Oper ating Pr oced ur es Pa tents Standard Standard Operating Operating Procedu Procedures Scanner Table Ass emb ly System Safety Operator Safety Safety Pa tient Sa fety Mechanical Safety Safety External External Symbols Symbols I nter n al Symbols Labels Emergency Stop Stop Buttonand Buttonand Failsaf Failsaf e Circuit Regis tr atio n Facilities Electrical Electrical Safety Safety Scatter Radiation System System Maintenance Maintenance ArchiveImage Files Test Emer gency Sto p Butto n PreventiveMaintenance PreventiveMa intenance DisposeofMaterials DisposeofMa terials Space Req uir ements ComponentSpecifications ComponentSpecifications Functional Functional Speci Specif f ications ications Envir onmenta l Specifications Power Specificatio Specification ns X- Ray Gener ator Specifications GE MEDI CAL SYSTEMS X-Ra y Tube Head Ass emb ly Co mp atib le Co mpo nen ts FDA Cer tified Components I ndex
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Tab able le of Co Cont nten ents ts I ntr oduction Sear ch Licens e and War r a nty I nfo r ma tion Gener al Pr odu ct I n for mation Training Training Information Information Cautions for DEXAD DEXADe eter minatio ns Pr ecautions fo r Standa r d Oper ating Pr oced ur es Pa tents Standard Standard Operating Operating Procedu Procedures Scanner Table Ass emb ly System Safety Operator Safety Safety Pa tient Sa fety Mechanical Safety Safety External External Symbols Symbols I nter n al Symbols Labels Emergency Stop Stop Buttonand Buttonand Failsaf Failsaf e Circuit Regis tr atio n Facilities Electrical Electrical Safety Safety Scatter Radiation System System Maintenance Maintenance ArchiveImage Files Test Emer gency Sto p Butto n PreventiveMaintenance PreventiveMa intenance DisposeofMaterials DisposeofMa terials Space Req uir ements ComponentSpecifications ComponentSpecifications Functional Functional Speci Specif f ications ications Envir onmenta l Specifications Power Specificatio Specification ns X- Ray Gener ator Specifications GE MEDI CAL SYSTEMS X-Ra y Tube Head Ass emb ly Co mp atib le Co mpo nen ts FDA Cer tified Components I ndex
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Introduction This manual contains contains safety safety and maintenanceinformati maintenanceinformation, on, and technic technical al specific specifications,for ations,for your bone densitomet densitometer. er. This This manualshould be used used with with theLunar enCO enCORE RETM OnlineHelp you receive received d with with your system. system. Theinformat Theinformation ion in this this manual is subjectto subjectto changewithoutnotic changewithoutnotice.You e.You mayuse or copy the the softwaredescri softwaredescribe bed d in this this manual only in accordance accordance with with theterms of your software software license license,, product warranty, or service service contract contract agreement agreements. s. No part of this this publicat publication ion maybe reproduce reproduced d for any purposewhatsoev purposewhatsoever,store er,stored d in a retrie retrievalsyste valsystem, m, or transmitt transmitted ed in any form or by any means, mechanical mechanical,, photocopying, photocopying, recording or otherwise,without otherwise,without theexpress written written permission permission of GE Medical Medical Systems Lunar. Anyreproducti Anyreproduction, on, photoco photocopyi pying ng and recordin recording g in whole whole or partis prohibit prohibited ed.. Any informat information ion containe contained d herein herein shallnot be disclosed closed to anycompany viewed viewed as a competit competitor or to GEMedical GEMedical Systems Systems Lunar. Lunar. GE Medic Medical al Syste Systems ms Lunar makes makes no warranty warranty of any kind kind with with regard regard to this this materi material,and al,and shallnot be held held liablefor liablefor errors contained tained herein herein or for incident incidental al or consequent consequential ial damages in connecti connection on with with thefurnishings or useof this manual. The information information contained contained in themanual is confident confidential ial and proprietary proprietary to GE MedicalSystem MedicalSystemss Lunar. This information information is provided only to authorized representat representative ivess ofGE Medical Medical Systems Systems Lunar's customers customers solely solely for the the purpose of facilit facilitating ating theuse of GE MedMedical ical Syste Systems ms Lunar's Lunar's products.No products.No informat information ion containe contained d herein herein maybe disclose disclosed d to any unauthorize unauthorized d person person for any purpose whatsoever whatsoever withoutpr withoutpr ior written written consentof GE MedicalSystem MedicalSystemss Lunar. Read theUser and theSafety theSafety and Specif Specificat ication ion manuals thoroughly before before using thesystem or attempt attempting ing to service service any components. ponents. Unauthorized Unauthorized service service may void system system warranties warranties or service service contracts. contracts. Consultthe GE MedicalSyste MedicalSystems ms Lunar Lunar Customer Customer ServiceDepartme ServiceDepartment nt beforeattempti beforeattempting ng any service: service: 800-437-1171 (U.S.A (U.S.A).). Lunar is a registere registered d trademark trademark of GE MedicalSyste MedicalSystems ms Lunar. Allother product and brand names are registere registered d trademarks trademarks or trademarks of their respectivecompan ies. Copy Copyrig right ht© © 1999,2000,2001,2002,2003,2004,2005,2006,2007,2008,2009 1999,2000,2001,2002,2003,2004,2005,2006,2007,2008,2009 GE Medical Medical Systems Systems Lunar, Madison, Wisconsin. Wisconsin. All rights reserve reserved. d.
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License and Warranty Information Pleasecarefully Pleasecarefully read thefollowing terms terms and conditions conditions before before installing installing or operating operating theGE MedicalSystem MedicalSystemss Lunar Soft Software ware ("Sof ("Software tware") ").. By installing installing or using theSoftwarein your GEMedical GEMedical Systems Systems Lunar product, product, You indicateyour indicateyour acceptanceof acceptanceof these these terms terms and condit conditions.If ions.If Youdo notagreewith theterms theterms and condit conditions,do ions,do not installor installor operatetheSoft operatetheSoftwareand wareand return return itto GE Medical Systems Systems Lunar . The Software Software has been been provided to You for use on a specificGE specificGE MedicalSyste MedicalSystems ms Lunar product.The Software Software is provided under theterms of this Agreementand Agreementand is llice icensed nsed to You, not sold. Your rights to use theSoftware theSoftware are subject subject to theterms and conditions conditions contained contained within within this License License Agreementand Agreementand GE MedicalSyste MedicalSystems ms Lunar reserve reservess any rights not expressly expressly granted to You. This Licenseis Licenseis non-exclusiveand non-exclusiveand a non-transferable non-transferable licenseto licenseto use theGE MedicalSyste MedicalSystems ms Lunar Lunar Software Software.. Re-distribut Re-distribution ion of Software Software or any documentat documentation ion provided to you you by GE MedicalSyste MedicalSystems ms Lunar is is strictlypr strictlypr ohibited. ohibited. This product includes includes some software software components components thatar e license licensed d under theGNU General General Public License(GPL). License(GPL). Sourcecode for GPL components components is is available available upon request. request. The terms terms and conditions conditions ofthis LicenseAgreeme LicenseAgreement nt and Limite Limited d SoftwareWarranty SoftwareWarranty are as follows: follows: 1. LICENSE. LICENSE. This License allows You to:
(a) use theSoftw theSoftware are on a product product in accordanc accordance e with with theaccompan theaccompanyin ying g docume document ntati ation. on. To "use" "use" theSoftw theSoftware are means means that that the the Softw Software are is either either loaded loaded in the the temporarymemoryof temporarymemoryof a comput computer er or install installed ed on any permane permanentmemoryor ntmemoryor media media of a comput computer er (e.g. (e.g.,, hard disk, disk, CD-ROM CD-ROM,, optic optical al disk, disk, zip disk, disk, and thelike) thelike);; (b) makeone (1)copy, (1)copy, in machine machine-rea -readableform,of dableform,of theSoftw theSoftware are as provided provided to You You solely solely for thepurposes thepurposes of backup; backup; provided provided that that such copyinclude copyincludess thereproduct thereproduction ion of any copyrightnoti copyrightnoticeor ceor other other proprietary proprietary notic notice e appearing appearing in or on suchSoftware suchSoftware.. 2. LICENSE RESTRICTIONS. (a) YOU MAYNOT, EXC EXCEPT EPT AS EXPRESS EXPRESSLY LY PROVIDED FOR IN THIS LICENSE LICENSE:: (i)DECOMPILE, (i)DECOMPILE, DISASSE DISASSEMBL MBLE, E, OR REVERSEENGINE REVERSEENGINEER ER THE SOFTW SOFTWARE(exce ARE(except pt to theextent theextent applicable applicable laws specific specifically ally prohibits uch restrict restriction);(ii) ion);(ii) COPY, COPY, MODIFY, MODIFY, ADAPT, ADAPT, TRANSF TRANSFER,TRANSER,TRANSLATE, LATE, RENT, RENT, LEASE LEASE,, GRANTA SECURITYI SECURITYI NTERES NTERESTT IN, OR LOANTHE SOFTW SOFTWAREOR AREOR ANYPORTION THEREO THEREOF; F; (iii) (iii) CREATEDERIVATIVE CREATEDERIVATIVE WORKSBASED WORKSBASED UPON THESOFTWAREOR THESOFTWAREOR ANYPORTION THEREOF THEREOF;; OR (iv) (iv) REMOVE REMOVE ANYCOPYRIGHTOR PROPRIETARYNOTICESOR PROPRIETARYNOTICESOR LABELS LABELS IN OR ON THESOFTWARE THESOFTWARE.. (b) Youunderstand Youunderstand that that GEMedicalSyst GEMedicalSystem emss Lunar may update update or revise revise the the Softw Software,and are,and in so doing incur incur no obligat obligation ion to furnish such updates updates to You under this this License License.. GE Medical Medical Systems Systems Lunar has no obligati obligation on to improve, improve, updateor suppo rt theSoftwarein thefuture. thefuture. (c) (c) In the the eventtheinstru eventtheinstrume ment nt or productdesignate productdesignated d for theSoftw theSoftware are is sold or otherwisetransf otherwisetransferre erred d to a third third party,that party,that party party is not authorized to use theSoftwareunless they they firstpay to GE MedicalSyste MedicalSystems ms Lunar theapplicablelicensefee and agree to the terms terms and conditions conditions of a SoftwareLicenseAgreeme SoftwareLicenseAgreement. nt. Upon transfer transfer of theSoftware theSoftware or any copy thereof,the thereof,the Licensegr Licensegr anted anted hereunder shall terminateimmediately. 3. TERM AND TERMINATION.
This License License is effect effectiveuntil iveuntil terminate terminated. d. This License License willterminate willterminate immediate immediately ly without without notice notice from GE Medical Medical Systems Systems Lunar or judicial resolution if You fail to comply with any provision of the License. Upon any termination of this License, License, You agree to return or destroy destroy theSoftware, theSoftware, all accompanying accompanying written written materials materials and all copies copies thereof thereof in any form. Sect Section ion 5 willsur viveany tertermination. 4. EXPORT LAW.
You agree thatneither thatneither theSoftware theSoftware nor any direct direct product thereof thereof is being being or willbe shipped, transferred transferred or re-exporte re-exported, d, directly directly or indirectly indirectly into any country prohibited prohibited under United United State Statess law or regulations regulations promulgated thereunder. thereunder. 5. WARRANTY.
GE MedicalSyste MedicalSystems ms Lunar warrants that, that, to thebest of our knowle knowledge, dge, theso ftware ftware provided with with this Licensewill Licensewill perform as described described in thepr oduct's operator's operator's manual and thetechnical thetechnical specific specification ation for this this Software Software.. This limit limited ed warranty is contingent contingent upon proper use of theSoftwareand does not cover cover any Software Software which has been been modified, modified, subjecte subjected d to malicious malicious logic, logic, unusual physicalor elect electrical rical stress, or used used on computer computer equipmentnot equipmentnot specifie specified d by GE MedicalSystem MedicalSystemss Lunar. GE MedicalSyste MedicalSystems ms Lunar does does not warrant thatthe functions functions contained contained in this Softwarewill Softwarewill meet meet your requireme requirements, nts, or thatthe operation operation of theSoftwarewill be uninterrupted uninterrupted or errorerror- free. free. State Statement mentss made made about this this Soft Software ware do notconstitutewarr notconstitutewarr anties anties
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and shallnot be relie relied d upon by Youin decidi deciding ng whethe whetherr to purchase purchase theGE Medic Medical al Syste Systems ms Lunar product product or use theSoftw theSoftware.IN are.IN NO EVEN EVENTT SHALLGE SHALLGE MEDICA MEDICALL SYST SYSTEM EMS S LUNAR LUNAR BELIABLE BELIABLE TO YOU YOU FORANYDAMAGE FORANYDAMAGES S ARISING ARISING OUTOF THEUSEOR INABILIT INABILITYY TO USE USE SUCH SOFTWARE. SOFTWARE. THESOLE AND EXC EXCLUSIVEREME LUSIVEREMEDY DY IN THEEVENTOF DEFEC DEFECTT IS EXPRESS EXPRESSLY LY LIMITEDTO THEREPLACEME THEREPLACEMENT NT OF THESOFTWAREP THESOFTWAREP ROVIDED. IF FAILUREOF THESOFTWAREHAS THESOFTWAREHAS RESULTE RESULTED D FROMACCIDENT FROMACCIDENT OR ABUSE, ABUSE, GE MEDICAL MEDICAL SYSTE SYSTEMSLUNAR MSLUNAR SHALL SHALL HAVENO RESPONS RESPONSIBILITY IBILITY TO REPLACETHE REPLACETHE SOFTW SOFTWARE ARE.. GE Medical Medical Systems Systems Lunar will will consider consider this this warranty to be void if You failto comply comply with with theterms in theSoftwareLicenseAgreement. 6. TITLE.
Title,ownership Title,ownership rights,a nd intelle intellect ctual ual propertyr ights ights in theSoftwareshall remain with with GE MedicalSystem MedicalSystemss Lunar. This Softwareis Softwareis protecte protected d by thecopyright laws and treatie treaties. s. 7. MISCELLANEOUS MISCELLANEOUS.. This Agreementrepresent Agreementrepresentss thecomplete thecomplete agreementconcerning agreementconcerning this License License and may be amended amended only by a writing writing execut executed ed by both parties. parties. The License License is governed governed by thelaws of theStateof Wisconsin, Wisconsin, U.S.A.without U.S.A.without regard to its conflictof conflictof laws principles. principles. If any provision provision of this this Agreem Agreementis entis held held by a courtof compet competentjuris entjurisdic dicti tion on to be unenforc unenforceab eable le,, that that provision provision shallbe enforce enforced d to themaximum extentpermissibleand/or extentpermissibleand/or reformed reformed only to theextent theextent necessary necessary to makeit enforceabl enforceable, e, and ther emaining emaining provisions visions of this this Agreem Agreementwil entwilll notbe affec affecte ted d or impaired impaired in any way.If any legal legal action action or proceedingis proceedingis broughtfor the enforce enforce-mentof this Agreement Agreement,, or because because of any alleged alleged dispute, dispute, breach,default or misrepresent misrepresentation ation in connecti connection on with with any of the provisions ofthis Agreeme Agreement, nt, thesuccessful or prevailing prevailing party shall be entitl entitled ed to recover recover reasonableattorneys' reasonableattorneys' fees fees and other other costs costs incurredin incurredin such action action or proceedi proceeding, ng, in addition addition to any other other reliefto reliefto which suchparty may beentitl beentitled. ed.
General Product Information Thebone densit densitome omete terr is designe designed d to estima estimatethebone tethebone min mineraldensi eraldensityand tyand body composit composition ion (leanand (leanand fattissue fattissue mass)of patients patients when medicall medicallyy indicate indicated d by their their physicians. physicians. The manuals provide provide instructions instructions for operating operating thesoftware and scan table, table, system system information, information, and maintenanceinformati maintenanceinformation. on. Variables Affecting Affecting Scan Results
Scan Scan results results can can be affect affected ed by operator techniqueand techniqueand patient patient variability variability:: 1. Operator Operator techniquerefers techniquerefers to patient patient positioning positioning and scan analysis.To minim minimize ize techniquevariables, techniquevariables, 1) establish establish consistentposit sistentpositioni ioning ng and scananalysis scananalysis routine routiness by usinganatomicallandmark usinganatomicallandmarkss when when positioni positioning ng patie patients,and nts,and 2) during during analysis,manipul analysis,manipulateraw ateraw scan data data onlywhen absolute absolutely ly necessa necessary. ry. 2. Patient Patient variabilityr variabilityr efers efers to changes in thepatient's thepatient's medic medical al history,metabolism, history,metabolism, and diet. diet. It also refers refers to to diagnosticpr diagnosticpr ocedures cedures thatinvolve radionuclide radionuclide uptakeand medical medical treatment treatment,, and thepr esenceof esenceof external external radiation radiation (particularlythe (particularlythe use of other other radiation-generat radiation-generating ing devices devices in thevicinity thevicinity of thesystem). thesystem). To minim minimize ize patient patient variability variability,, 1) thoroughly familfamiliarize yourselfwith thepatient's thepatient's history,and 2) install install thescanner in an environmenteffe environmenteffect ctive ively ly shielded shielded from other other sources of external external radiation. radiation. CAUTION: United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician (USA only).
Training Information GE Medical Medical Systems Systems Lunar or authorized authorized GE MedicalSyste MedicalSystems ms Lunar distributors distributors provide provide individual, individual, hands-on training training as part of theinstallation theinstallation procedurefor your system. system. (GEMedical (GEMedical Systems Systems Lunar distributors distributors provide training training for systems systems installed installed outside theUnited State States.) s.) An Appli Applicati cations ons Special Specialist ist provides information information on softwareand hardware operations, operations, and reviews reviews thewarnings and cautions cautions in the the manuals. 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 the GE Medical Systems Lunar Customer Service Department at 800-334-5831, or your local GE representative.
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Cautions for DEXA Determinations Youshould be awareof thefollowing factors which mayaffecttheclinicalaccuracy of DEXA spineestimates: marked distortions of skeletal architecture-e.g.,os teophytes, degenerativedisc disease, spinal arthritis, spondylolisthesis, kyphoscoliosis, and vertebral fractures-and significantcalcium deposits in theaor ta can falsely elevate spine bone mineral values. Regions thatcontain these dystrophiccalcifications can be excluded from thescan analysis in some cases.The scanner can be used to monitor changes in bonemineral over timein patients with these disorders,but caution mustbe taken in interpretation.Use DEXA estimates as an aid to other methods in theevaluation of patient bone mineral status in theclinicalsetting. In addition, spine estimates will be difficult to interpretfor patients with orthopedic metal devices and previous surgical interventions, such as bone grafts.Radiographic contrastmaterialand radiopharmaceuticals used for myelograms, barium enemas, and other diagnostictests prevent accurate estimates. Barium clears the body within a few days,but theoil-based dyes used in myelograms several years ago may remain within thebody for years. A three-day waiting period is sufficient time for barium and most radiopharmaceuticals to becompletelydischarged from thebody. 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 arepr osthetic devices and surgical implants in theregion of thebone scan.Results maybe adversely affected ifthe patient has difficultywiththe desired 25° inward rotation of theleg or with maintaining this position without movement. TotalBody estimates requireconsistentpatient positioning for accurateresults and willbe difficult to interpretfor patients with orthopedic metal devices and previous surgical interventions.The operator should pay particular attention to thelocation of the patient's arms, keeping thepos itioning thesame for each scan. Results may be affected if thepatientmoves during thescan.
Precautions for Standard Operating Procedures 1. Do not attemptto operatethe scanner without firstr eading this manual. 2. Do not removethe assemblypanels or attemptany repairs without prior instructions from authorized GE MedicalSystems Lunar personnel. 3. Perform the Quality Assuranceprocedure each morning. If any test fails,check theposition of thecalibration block and rerunthe QA procedure. If a test fails again, contactGE Medical Systems Lunar Support. Also, call GEMedicalSystems Lunar ifmore than two failures occur in a one-weekperiod.If theroom temperature changes more the5°C during the day,then performanother Daily QA. 4. If thepatient is or mightbe pregnant, always contactthepatient's physician before performing a scan. 5. Remain in theroom with thepatientwhile a scan is in progress. Assurethepatientdoes notmove during the measurement. Minimizethe amountof timethe patient lies flat on thescan table. 6. Restrictaccess to theroo m to authorized personnel. 7. Do not attemptto serviceany of thesystem's electrical components whilethescan tableis turned ON. High voltage is used to producex-rays. 8. Radiation safety information is located within this manual you received with your system. Review this information before operation. 9. To stop the scanner in an emergency, press the emergencystop buttonon thescan arm.DO NOT use theemergency stop button to routinely aborta scan. 10. Remove any fluids which are spilled on pad or any surface of tableimmediately. 11. All surfaces should be cleaned to meetsite's guidelines for handling blood and body fluids.Pad material maybe damaged by certain chemicals Use appropriate hospitalgr ade disinfectantfollowed by mild detergent. 12. Do notgeneratex-rays through theuse of remoteapplications.
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13. Protect thecomputer against malicious logicand unauthorized network access. Only allow authorized user access. Preventvirus attacks through theuse of firewalls,an ti-virus software and software patch updates. Contact your localGE representative for more information. 14. DPX Duo: Extendthe step thefull distanceto provide maximumsurfacearea for thepatientto geton and offthetable withoutrisk of injury. 15. DPX Duo: Do notplacean excessive loadon footrest(stirrup), drawers, or leg extension. 16. DPX Duo: Do notsit on leg extension table.
Patents This productis covered by theclaims of oneor moreof thefollowing patents: U.S.patents #5,040,546, #5,306,306, #5,480,439, #5,533,084, #6,038,281, #6,081,582, #U520050249331A1, #U520050247882A1, #U520050247880A1
Standard Operating Procedures 1. Quality Assurance: Every morning, before you start patient measurements, completethe daily Quality Assurance procedure. Refer to chapter 2 ofthe enCOREOperator's Manual.Make sure you save your printed results for future reference. 2. Measure Patients: If time allows,enter thePrimary, Secondary, and Additional data for thepatients you expect to measure during theday. Refer to chapter 3 ofthe enCORE Operator's Manualto measure a patient. 3. Analyze Results: Analyzeand print results immediatelyafter each patient measurementif time allows.Otherwise, analyze all of thepatientfiles after the last patient has been measured. Refer to chapter 4 ofthe enCORE Operator's Manual to analyze results. 4. Archive image files: Archive your imagefiles before you leavefor theday. In theunlikelyevent of a computer malfunction, it is very importantthat you have archived files of all of your patient measurements to rebuild your database. Refer to Archive imagefiles on page 30 for archiveprocedures. 5. Shut down computer: Attheend of the day,selectExit fromthe Main screen,selectShutDown fromthe Close window, and click OK to close theprogram. Note: Do notturn offthescanner at the endof theday for stationary systems.
Scanner Table Assembly Note: Do not attemptto servicethe scanner tableassembly. Please callGE MEDICAL SYSTEMSLunar Support or your GEMEDICAL
SYSTEMSLunar distributor.
Scanner table Thescanner tableis used to supportthe patient duringa measurement or general examination (DPX Duo). In addition,thex-ray source assemblyand other electronics arecontained insidethe scanner table.
Scanner arm The laser light, emitted from an apertureon thescanner arm, helps you locate themeasurement start position. Positioning switches letyou movethe scanner arm untilthe laser lightis located at thecorrect start position. The start position is different for each measurementtype. TheDPX Duo and DPX Bravo scanner arm has a releaseand locking mechanism allowing theupper arm to swivel when the scanner is idle. The scanner arm must be in thelocked position over thescanner tableto perform a measurement.
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Display panel The following describes theindicators located on thescanner arm display panel: Indicator
Status (on)
Green (power) Yellow(x-ray) Yellow(shutter) Amber (laser)
Power is supplied to thescanner table. X-ray tubeassemblyis supplyingx-rays. Shutter is open. Laser is on.
Emergency stop button Push thered emergencystop buttonto stop the scanner arm and immediately shutdown x-rays in an emergency. Do notuse the emergencys top button to routinely stop thescanner during normal operation.
Positioning switches The positioning switches move thescanner arm and detector to themeasurement start position (the laser light indicates theposition of thedetector). The Back/Front switch moves the detector across thewidth of thescanner table.The Left/Right switch moves thescanner arm down the length of thescanner table.
Swing arm position sensing switches (DPX Duo, DPX Bravo) Theswing arm position sensing switches detectthelocking status of theswing arm and theswing arm latch. Theswing arm latch mustbe locked and theswing arm mustbe in thelocked position over thescan tablebeforea measurement can be performed. Release of the swing arm latch duringa measurementwill abortthe scanand the measurementdata will be lost.
iDXA Start Scan button The start scan button initiates thepatientmeasurement. The start scan button is located on thedisplay panel near thepositioning switches.
System Safety Obeythese safety guidelines at all times: q q q
q q q
q
Read themanualbeforeyou operatethescanner. Thetechnologistoperating thescanner mustremain in theroom with thepatientduring the measurement. Do notattempt to service thescanner. Please callGE MEDICAL SYSTEMSLunar Support or your GEMEDICAL SYSTEMS Lunar Distributor. When thescanner is not in use, makesure theShutter Open,X-ray, and Laser lights are off. Do not putexcessive pressure on the scanner arm. Usethe scanner table for patient measurements and examinations (DPX Duo)only:do notsit, stand or lie on thetable for other purposes. Do not letliquids touch thecomputer or scanner tablemechanics and electronics.
Operator Safety Personnel monitors Personnelmonitors are not necessary to operatethe scanner. It is notlikely that you can receivemore than 25% of the maximumpermissible x-raydose fromthe scanner.However, somefacilities chooseto use personnelmonitors. Refer to your city,county or stateHealth Departmentor Radiation Safety Officer for your facility's policy. Film badges and thermal luminescentdosimeter (TLD) badges are obtained from a supplier accredited by theNational Voluntary Laboratory Accreditation Program for personneldosimetry processing. Thefollowing is a sample situation for a clinic measuringan AP spine and DualFemur on 5 subjects per daywith an exposurerate of 0.18mR/hr ata distanceof 2 meters estimated fromthe iDXAisodosecurves.
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Sample Calculation for Estimated Exposureper Year from Scatter with iDXA Densitometer
Scan Type
Mode
AP Spine Standard Dual Femur Standard 2.5 mA Scan Time per Day (sec) 2.5 mA Scan Time per Day (hours) 2.5 mA Scan Time per Week (hours) 2.5 mA Scan Time per Year (hours) 2.5 mA Exposure from Isodose Plots (mR/hr) Total Exposure for 1 Year (mR) Total Absorbed Dose for 1 Year (mRad) 0.92 Rad/R
Average Scans/Day
Scan Time/Day (sec/day)
5 5
260 535
Equivalent 2.5 mA Scan Time/day (sec/day) 260 535 795 0.221 1.11 57.5 0.18 10.3 9.5
X-ray and shutter graphics During a measurement or Quality Assuranceprocedure, x-rayand shutter graphics are shown on thecomputer monitor.The graphics are green to indicatex-rays are off and theshutter is closed, and yellow to indicatex-rays are on and theshutter is open. X-rays off and shutter closed ( green ):
X-rays on a nd shutter open yellow ( ):
X-ray shutter When power to thescanner is interrupted during a measurementor Quality Assurance procedure, theshutter closes and thexray tubestops generating x-radiation.
X-ray power supply Thex-ray tube assembly uses highvoltage to generate x-rays. DO NOT touch internal components. DO NOT attempt to service internal components.
Patient Safety Pinch points The Warning labelidentifies thelocation of possible pinch points.
When thescanner arm is in motion,makesure possiblepinch point areas are clear at alltimes. Patientlimbs mustremain inside theboundaries of thetable top. A pinch pointis possible between thescanner arm and table.
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Not Available
APVA
Thin
Orthopedic Femur Orthopedic Femur Orthopedic Femur
Thick Standard Thin
1.500 1.500 0.375
Small A nima l
Standar d
Not Available
20.1 x 15.0 20.1 x 15.0 20.1 x 15.0
385 223 385
41 20 5
Current and typical dose information for DPX-MD+ modes. Note, Standard mode is replaced with Standard-MD mode.
Mode 1
Site
AP Spine Femur Orthopedic Femur
Standard-MD Standard-MD Standard-MD
Current (mA) 2
Typical Measurement Area L x W cm x cm 4,5
Irradiation times (sec)3,4,5
Estimated Skin Entrance Dose 6 (μGy)
0.750 0.750 0.750
15.0 x 12.0 15.0 x 12.0 15.0 x 12.0
212 236 336
20 20 20
1 All modes are 76kV, ±1kV. 2 Tubecurrent is ±1% at themaximum current. 3 Imaging time measured from shutter open to shutter close, 90% to 100% of indicated value. 4 Sizes of measurementareas and irradiation times willbe less than thoselisted above if you use theSmartScan feature. 5 Measurement lengths and times are dependenton patient height and product version. 6 Dose measurements are constrained by DailyQA limits. For example,the maximum spine (standard mode)rang e is 30 to 85μGy for Prodigy densitometers and 8 to 28μGy for DPX series densitometers. 7 Irradiation times and dosevalues do notconsider a “sweep retry” featurewhich can double thedose for a single transverse sweep within an entirescan. If a retry occurs aslightincrease in irradiation timeand skin entrancedose would be expected. On Lunar Prodigy scanners DF+12000 and above, allProdigy Advance, and DPX+NT scanners running version 8 softwareand newer,a sweep may be retried onetimeduring acquisition. A maximum of two sweeps can be retried per scan. Theretryfeature reduces need to rescan entire patient.
Mechanical Safety The scanner arm moves down theentirelength of thescanner table. Makesure thepatientdoes not interferewith themovement of the scanner arm to preventpossible injury. In addition,makesure that there are no objects behind thescanner tablethatmight obstructmovement of thescanner arm. Weight applied to theLunar iDXAmust not exceed 204kg (450 pounds). Weight applied to theLunar DPX-Pro/NT/MD+ scan table bed mustnot exceed 136kg (300 pounds). Weightapplied to theLunar PRODIGY,PRODIGY Advance, PRODIGY Primo, DPXDuo/Bravo scan tablebed or footstep (DPX Duo)must notexceed 159kg (350 pounds).
External Symbols
Attention: shows theOperator's Manual contains importantsafetyinformation such as thelocation of pinch points.
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Emergency Stop Button: shows thelocation of theemergency stop button.
Laser On: shows thelocation of theLaser On indicator.
Shutter Open: shows the location of theShutter Open indicator.
X-ray On: shows the location of the X-ray On indicator.
Type B Equipment: shows that thes canner has Type B protection against electrical shock.
Power On: shows thelocation of thePower On indicator and theswitch position for Power On.
Power Off: shows theswitch position for Power Off.
Internal Symbols
Protective Earth: shows thelocation of a Protective Earth terminal.
Functional Earth: shows thelocation of a FunctionalEarth terminal.
Labels Laser Caution and Ionizing Radiation Label :
Shows that thescanner uses a Class II laser. The label includes the required symbols and precaution (Laser Radiation: Do not stare into beam. Class II Laser Product).
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Tube Head Assembly "Lunar iDXA" Label:
This label gives tube head assembly and xray source characteristics information. It is located on thetube head assembly and the footpanelofthe scanner. Thelabel appearance mayvary fromthe onedisplayed here. The Lunar iDXA series label covers appr opriateTubeHead Assembly for Lunar iDXA scanners.
Tube Head Assembly “DPX Series” Label: This
labelgives tubehead assembly and x-ray sour ce characteristics information. It is located on thetubehead assembly and thefoot panel of the scanner. Tube Head Assembly labelcovers DPX-NT, DPX-MD+, DPX Bravo, andDPX Duo.
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Tube Head Assembly “Prodigy Series” Label:
This label gives tube head assembly and xray sourcecharacteristics information. It is located on the tube head assembly and the footpanelof the scanner. Thelabel appearance may vary fromthe onedisplayed here. TheProdigy series labelcovers appropriate TubeHeadAssembly for Prodigy and Prodigy Advancescanners.
Inherent Filtration: Sym-
bol fromEN60417-1, 5381 Tube Insert: Symbol
fromEN60417-1,5337 X-ray Source: Symbol fromEN60417-1,5338 Focal Point: Symbol
fromEN60417-1,5327 System Label: This label gives s ystem input power requirements and complianceinformation. It is located on the foot panel of scanners.The Attention symbol indicates need to read accompanying documents. Person symbol refers to Type B applied part for degreeof electric shock protection per EN60601-1. TheFan symbol denotes ionizing radiation is g enerated. TheCEmarkshows compliancewith theMedical DeviceDir ective 93/42/EEC. TheETL mark shows compliance to UL 60601-1 and CAN/CSA C22.2 No. 601 The Waste Receptaclemark indicates thatthe waste of electrical and electronicequipmentmust notbe disposed as
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unsorted municipal waste andmustbe collected separately. Please contact an authorized representativeof the manufacturer for information concerning the decommissioning of your equipment. High Voltage Power Supply: This label gives high voltage power supply (x-ray generator) information. It is located on thehigh voltage power supplyand foot panel of the scanner. Prodigy/DPX series High Voltage Power Supply labelcovers allthe latest Lunar products since theyuse thesameHVPS partnumber.
X-ray Controller: This
label shows x-ray controller compliance. It is located near the x-ray controller and on the footpanelofthe scanner. TheLunar iDXA X-ray Controller Assembly labelcovers all theLunar iDXA products. Prodigy/DPX series Xray Controller Assembly labelcovers allthe latest Lunar products. Labels show model/serial number for that specific product. Collimator Assembly: This label gives collimator ass embly information. It is located on thecollimator and foot panel of the scanner. TheLunar iDXA Collimator Assembly label covers all Lunar iDXA products.P rodigy/DPX series Collimator Assembly labelcovers latestLunar products. Labels s how model/se-
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rial number for that specific product. Warning Label and Radiation Symbol: The Warning label shows thatthe system uses ionizing radiation.It is found onlyon systems delivered in theUnited States. Always obey instructions for safe operation. Grounding Reliability Label: This label states thatgr ounding reliability can onlybe maintained when usinga "Hospital Grade"or "HospitalOnly" receptacle.I t is found on allpower cords ofsystems delivered in the United States.
Emergency Stop Button and Failsafe Circuit If thehar dware malfunctions, thescanner has two safety features for operator and patient safety: an Emergency Stop button and a Failsafe Circuit.
CAUTION:
Beprepared to abortthescan in theunlikely eventarm motion stops with thex-rays on.
Emergency stop button Theemergencystop button is theround, red buttonlocated on thescanner display panel. NOTE: When theEmergency Stop Buttonis pushed, data is not saved to thedatabase. Youmust measurethe patient
again. 1. Push theEmergencyStop buttonto stop a measurement in an emergency. Power to the scanner tablemotors,x-ray tube head, shutter, and laser is turned off. NOTE: Do notuse theemergencystop buttonto routinely stopthe scanner during normaloperation.
2. Select OK in the messagewindow on thecomputer screen. NOTE: If there is a hardwareproblem,DO NOT try to measurea patient. CallGE MedicalSystems Lunar Support or your
GE MedicalSystems Lunar distributor.
Failsafe circuit During a diagnostic failure, theFailsafeCircuitstops power to thescanner motors and closes thex-ray shutter. A messageis shown on thecomputer thatdescribes thefailure. Call GE MedicalSystems Lunar Support or your GEMedical Systems Lunar distributor and provide thefailure description.
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Registration Government health departments can requiremedicalfacilities to register diagnosticx-ray equipment. Many municipal and state health agencies require medical health facilities to employ certified radiologictechnologists to operate diagnostic x-ray devices. Contactyour localr egulatory authorities or GE representativefor registration guidelines and regulation compliance.
Facilities Installa "Caution X-Radiation" sign in the areaor room where the systemis operated.Becauseof low leakagelevels of radiation fromthe x-raytubeassembly, additionalshielding in thewalls, floor, or ceiling is notnecessary.However,callyour stateor local health and radiation safety departments for shielding requirements.
Electrical Safety WARNING:
Insulate patient fromany metal associatedwith the DPX Duo by usinga nonconductivematerialdu ring cauterization or similar treatments to avoid shock or burns. Do not plug additional outletstrips or extension cords into power connected to scanner.
IEC and UL/CSA certification To maintain electrical safety, all computer equipmentand accessories connected to thescanner must meet all requirements for safety. U.S.A.and Canada requireUL/CSA and FCCcertification. European countries requireCE mark certification. Other countries should follow their local requirements for computer equipment and accessories certification. Declarations of conformity to the required standards should meet or exceed therequirements of EN 60950, "Safety of Information Technology Equipment" and EN 55024 "Information Technology Equipment- Immunity Characteristics".
Electromagnetic interference Although thescanner meets safety standards regarding electromagnetic interference (EN60601-1-2), you may still experience a loss of performance under extremeelectromagneticconditions.Maximizethe distance between thescanner and other equipment. Use a dedicated power lineto avoid interference to and from thescanner.
Electromagnetic Compatibility (EMC) Performance Alltypes of electronic equipmentmay characteristically cause electromagnetic interference with other equipment, either transmitted through air or connecting cables. The term EMC (Electromagnetic Compatibility) indicates thecapability of equipmentto curb electromagnetic influencefrom other equipment and at thesa me time not affectother equipment with similar electromagnetic radiation from itself. Proper installation following theservicemanual is required in order to achievethe full EMC performance of thepr oduct. In case of issues related to EMC, pleasecall your service personnel.
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EMC Environment and Guidance
-Floors should be wood, concrete, or ceramic tile. If floors are covered with syntheticmaterial, ther elative humidity should beat least30%. -A UPS (uninterruptable power supply) is required to pass 61000-4-11 test at the100V levelfor iDXA. -Mains power quality should be thatof a typical commercial and/or hospitalenvironment. If theuser requires continued operation during power mains interruptions, itis recommended thatthe system be powered through a UPS. -Separation distance to radio communication equipmentmust be maintained according to themethod in thefollowing table. -NOTE: Theseguidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. -The Lunar densitometer is suitable for use in all establishments, including domestic establishments and those directly connected to the publiclow-voltagepower supply network thatsupp lies buildings used for domesticpurposes.
Recommended Separation Distance between portable and mobile RF communications equipment and the Lunar densitometer TheLunar iDXAis intendedfor use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or theuser of theLunar iDXA can help prevent electromagnetic interferenceb y maintaining a minimum distance between portableand mobileRF communications equipment(transmitters) and theLunar densitometer as recommended below, according to themaximum outputpower of thecommunications equipment. Rated maximum Separation distance according to frequencyof transmitter in meters outputpower of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz W 0.01 0.1 0.1 0.2 0.1 0.4 0.4 0.8 1.0 1.2 1.2 2.4 10 3.7 3.7 7.4 100 11.7 11.7 23.3 NOTE1: At 80 MHz and 800 MHz, theseparation distance for thehigher frequency range applies. NOTE2: These guidelines may not apply in all situations. Electromagneticpropaga tion is affected by absorption and reflection from structures, objects and people.
Peripheral configurations WARNING:
The correctconnection of thecomputer and all peripherals is necessary to maintain electrical safety. The signal cableof thescanner is intended only for connection to an approved computer. CallGE MedicalSystems Lunar Support or your GE MedicalSystems Lunar distributor before adding peripherals. Operator shall not touch patient and computer or peripherals simultaneously.
Standard room configuration Thecomputer,peripherals, and allother equipment mustbe located morethan 1.5 m or 1.83 m (U.S .A and Canada)from the scanner. Usean outlet strip to power thecomputer and allperipherals.The outlet strip mustbe mountedoff thefloor so that it does not touch other equipment. If your outletstrip was provided by GEMedicalSystems Lunar, ithas a maximum outputof 15A, 120VAC.Only system-related equipmentshould be powered by the outlet strip.
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A modem and/or network connection can be madeat any timeif you are usingthe standard room configuration.
Small room configuration Youmust power the computer,peripherals, and allother equipmentwith an isolating transformer if the room is too small to maintain at least1.5 m or 1.83 m (U.S .A and Canada)of separation between thescanner and allother equipment. The isolation transformer supplied by GE MedicalSystems Lunar has a maximum outputof 400/500VA. Only system-related equipmentshould be powered by the isolation transformer.Failure to use an isolation transformer can cause leakagecurrents in excess of 100 microamperes. A modem and/or network connection can onlybe madein thesmallroom configuration ifall exposed metalsurfaces of thecomputer and peripherals are out of thepatientenvironment.
Lunar PRODIGY system no. DF+11999 and lower Scanner power output configuration: GE MedicalSystems Lunar recommends thatyou use scanner power outputto provideiso-
lated power to thecomputer and allperipherals. Thepower strip mustbe mounted offthefloor such that itdoes not touch other equipment. Thecomputer and ALLperipherals must bepowered by thescanner. Allother equipmentmustnot be powered by the scanner andmust be located morethan 1.5 mor 1.83 m (U.S.Aand Canada)from the scanner. Failure to usescanner power output can cause leakage currents in excess of 100 microamperes. If a network and/or modem connection is needed, refer to the wall outlet configuration. Wall outlet configuration: As an option to scanner power output, a walloutletcan be usedto power thecomputer and periph-
erals. Isolated power fromthe scanner mustnot be used to power any equipmentif a wall outlet is used. Allexposed metalsurfaces of the computer,peripherals, and other equipment mustbe located morethan 1.5 m or 1.83 m (U.S .A and Canada) fromthe scanner. A network and/or modem connection can be madeto thecomputer if power is supplied froma wall outlet as describedabove.
Scatter Radiation The following display isodose diagrams of theLunar iDXA fullsize scanner scatter radiation. The measurements conformed to the IEC60601-1-3:1994 standard and were takenwith a Victoreen 6000-532 400cc Ion Chamber PaddleProbe. Thebeam was attenuated according to Clause 29.208.6 section a) which specifies a water targetwith dimensions 25x25x15 cm with container walls equivalentto less than 1 cm of polymethyl-methacrylate (PMMA), otherwise known as Lucite. Each measurementconsisted of a staticexposureat themaximum X-ray tube current and voltage of 2.5mA and 100kV.
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Isodose diagram - Lunar iDXA Full Size Table
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Thefollowing display isodose diagrams of theLunar PRODIGYand PRODIGY Advancefullsize and compactscanner scatter radiation.The measurements weretaken with a Victoreen 470A. The beam was attenuated through a 20.32 cm water phantom.
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Isodose diagram - Lunar PRODIGY, PRODIGY Advance, PRODIGY Primo, PRODIGY Pro Full Size Table
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Isodose diagram - Lunar PRODIGY, PRODIGY Advance, PRODIGY Primo, PRODIGY Pro Compact Table
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The following display isodose diagrams of scatter radiation for thefull-size and compactLunar DPX-NT/Pro and MD+ scanners, theDPX Duo and DPX Bravo scanners.The measurements were taken with a Victoreen 470A.The beam was attenuated through a 20.32 cm water phantom.
Isodose diagram - Lunar DPX-Pro/NT/MD+ Full Size Table
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Isodose diagram - Lunar DPX-Pro/NT/MD+ Compact Size Table, DPX Duo and DPX Bravo
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System Maintenance Clean Scanner Table Environment Vacuum and dustthe systemsiteweekly. Dustthe surface of the systemregularly and usenonabrasivecleaners to removedirt. Do not let liquids insidethe scanner table. NOTE: DO NOT connect a vacuum cleaner to thesa me electrical outlet as thescanner.
WARNING:
CAUTION: (Small AnimalOption)
Proper cleaning and handling procedures mustbe followed to prevent theposs ibilityof cross-infections between subjects scanned on thesamesystem. Cleanand disinfectthesystem according to your locala nd countrys pecifichygienicr egulations.Protecttable pad and tabletop fromwetness and preventthe ingress ofliquid into thescanner by protectively covering thescanner with a waterproof material. Device softwarefor investigationaluse on laboratory animal or for other tests that do not involve human subjects.
Unauthorized network access Today, thedelivery of healthcare to patients increasingly relies on modern information technology (IT)to electronically collect, process, distribute, display,and store patient data. Any computer connected to a network is vulnerableto network virus and/or other malicious attacks. Owners and operators of any medical devicethat is connected to a network are responsiblefor protecting their computers from these malicious attacks.
Virus protection software with enCORE You can protect your computers by following standard computer practices used for allinformation technology.Virus checker programs are an appropriate measureto assure electronic media and files are virus freebefore being introduced to your computer or network. The latest operating system updates should also be installed. Contactyour localGE representativefor more information. However, contact your service representativebefore performing any operating system updateto assure fullcompatibility. Activevirus checker programs should be installed and active on theenCOREcomputer operating thebone densitometer. However, virus scanners have significantdrawbacks including thefollowing: q Do not initiatean anti-virus scan when operating thebone densitometer. Certain files willbe marked read-only. q Anti-virus software may act inappropriately on falsepositives. Double check quarantinestatus beforetaking any permanentaction.Medicalimage files can be damaged becausethe virus scanner attempts to fix what it falsely identified as a virus. q enCORE software may not operateproperly if thevirus scanner consumes too much memory or system resources.
Archive Image Files Each day,archive newimagefiles fromyour computer hard drive to an archivedisk.This procedure creates freespace on your hard drive. Theprogram identifies archived files by labeling themwith thedrivelocation and the number of thearchivedisk: theprogram begins with number 1. For example:the third archivedisk located in drive A is labeled "A:A3."Labels for archivedisks are shown in theLabel column of theImagefileliston the Directory screen. It is importantthatyou label (write) thearchivenumber on each archivedisk. If itis necessary to restore archived files to thehard drive or rebuild your database, theprogram requires that you use theappropriatearchivedisk(s) accordingto its label. 1. Select Directory fromthe Main screen or theCommon tool bar. 2. Completeone of theprocedures that follow:
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q
Archive all images for all patients-1) select Archive fromthe Directory tool bar and 2) select "Archiveall images for
allpatients" in themessagebox that is shown. q
Archive all exams for all patients in the current search results-1) select a search field fromthe dropdownmenu,
2) enter search criteria in thefield provided, 3) click the search button, 4) select Archive fromthe Directory tool bar, and 5) select "Archiveall exams for allpatients in thecurrent search results"in themessagebox that is shown. q
Archive all images for selected patient-1) select a patient fromthe PatientList,2) select Archive fromthe Directory
tool bar, and 3) select "Archiveall images for selected patient" in themessagebox that is shown. q
Archive selected exam-1) select a patient fromthe Patient List, 2) select the patient imagefileyou wantto archive, 3)
select Archive fromthe Directory tool bar, and 4) select "Archiveselected image" in themessagebox that is shown. 3. Select OK. Theprogram archives the image files fromthe computer hard drive to thearchivedisk or external hard drive. Thearchive number for thefile is located in theLabel column of theImagelist. 4. If an archivestoragesourceneeds to be initiated, the program prompts you to insert a labeled archivedisk in theappropriate diskdrive. Inserta newor labeled diskas indicated. NOTE: Refer to theenCOREOperator's Manual on changing thedr ivelocation used to archivefiles.
Test Emergency Stop Button Test theemergency stop buttononce a month. Refer to theprocedurethat follows: 1. Starta standard total body measurement.Do nothave a patient on thetable. 2. Push theemergencystop button. Make surethe X-ray and Shutter lights are offand that a messageon the computer monitor indicates theemergency stop button is activated. 3. Push theemergencystop buttonagain to reset thesystem(Prodigy Series, DPX-Pro/NT/MD+/Bravo/Duo only). 4. Do notsave thepatient measurement. NOTE: If theemergency stop proceduredoes not work, callGE MedicalSystems Lunar Support or your GE MedicalSys-
tems Lunar distributor.
Preventive Maintenance X-ray tube and laser assemblies Thereare NO USER-SERVICEABLE COMPONENTS inside thex-ray tube head and laser assemblies.DO NOT attempton-site servicing. CallGE MedicalSystems Lunar Support or your GE MedicalSystems Lunar distributor immediately if thesystem malfunctions. DO NOT attemptto maintain or repair the components and scanner table. Doing so voids all currentwarr anty and service con-
tracts.
Daily Quality Assurance procedure CompleteQuality Assurance procedures daily. Makesure each QA procedurepass es. Refer to theenCOREOnline Help for detailed instructions. If your systemdoes notpass a test,check theposition of thecalibration block and completetheQualityAssuranceprocedure again. If thepr ocedure fails a second time,call GE MedicalSystems Lunar Supportor your GEMedicalSystems Lunar distributor.
Annual maintenance GE Medical Systems Lunar recommends thatyou schedule annual preventive maintenance from an authorized GE MedicalSystems Lunar serviceengineer after your war ranty period expires. ContactGE MedicalSystems Lunar or your GE MedicalSystems
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Lunar distributor.
Dispose of Materials The scanner contains lead (for x-ray shielding) and either sodium iodideor cadmium zinc telluride(used for x-ray detection). WEEE Label: This symbol indicates that thewaste of electrical and elec-
tronic equipmentmustnot be disposedas unsorted municipal waste and must be collected separately. Pleasecontactan authorized representativeof themanufacturer for information concerning the decommissioning of your equipment. If you contractwith GE Medical Systems Lunar for the disposal of your scanner, GE Medical Systems Lunar will properly dispose of these materials.If you choose to dispose of your scanner yourself, both substances mustbe disposed of in accordance with local regulations. Contactyour localGE representativefor more information.
Space Requirements For safety reasons, thecomputer and allperipherals mustbe in the sameroom with thescanner.
Lunar iDXA Full size Table Standard room configuration: Thecomputer and peripherals mustbe located morethan 1.5 m or 1.83 m (U.S .A and Canada)
from thescanner. Recommended room dimensions are: 4.0 meters x 3.35 meters (13.2 feetx 11 feet) Small room configuration: Roomdimensions must be atleast3.2 m x 3.35 m if the computer andperipherals arepowered by
an isolation transformer.Equipment powered by an isolation transformer can be located anywherein the room with thescanner. The isolation transformer and scanner must be plugged into thesame dedicated lineoutlet.
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Lunar PRODIGY, PRODIGY Primo, PRODIGY Advance, PRODIGY Pro, DPX-Pro, DPXNT, DPX-MD+ Full size Table Standard room configuration: Thecomputer and peripherals mustbe located morethan 1.5 m or 1.83 m (U.S .A and Canada)
from thescanner. Recommended room dimensions are: 3.7 meters x 3.7 meters (12 feetx 12 feet) Small room configuration: Roomdimensions mustbe at least 3.0 m x 2.4 m ifthe computer and peripherals are powered by an
isolation transformer.Equipment powered by an isolation transformer can be located anywhere in the room with thescanner. The isolation transformer and scanner must be plugged into thesame dedicated lineoutlet.
Lunar PRODIGY system no. DF+11999 and lower Scanner power output configuration: It is recommended that thecomputer and allperipherals be powered by thescanner
(scanner power output). I f scanner power outputis used, thecomputer and peripherals can be placed anywherein theroom. Room dimensions mustbe at least 3.0 m x 2.4 m.
Lunar PRODIGY, PRODIGY Primo, PRODIGY Advance, PRODIGY Pro, DPX-Pro, DPXNT, DPX-MD+, Compact Table and DPX Bravo Tables Standard room configuration: Thecomputer and allperipherals must be located morethan 1.5 m or 1.83 m (U.S .A and Canada)
from thescanner. Recommended room dimensions are 2.3 meters x 3.7 meters (7.5 feet x 12 feet). Small room configuration: Roomdimensions must be at least 2.3 m x 2.4 m (7.5 feet x 8 feet) ifthe computer and peripherals are
powered by an isolation transformer.Equipment powered by an isolation transformer can belocated anywherein theroom with thescanner. The isolation transformer and scanner must be plugged into thesame dedicated lineoutlet.
Lunar DPX Duo Table Standard room configuration: Thecomputer and allperipherals must be located morethan 1.5 m or 1.83 m (U.S .A and Canada)
from thescanner. Recommended room dimensions are 2.3 meters x 3.7 meters (7.5 feetx 12 feet). Small room configuration: Roomdimensions must be at least 2.4 m x 2.8 m (8 feet x 9 feet) ifthe computer and peripherals are
powered by an isolation transformer.Equipment powered by an isolation transformer can belocated anywherein theroom with thescanner. The isolation transformer and scanner must be plugged into thesame dedicated lineoutlet.
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Component Specifications Specifications for standard components shipped with thesystem. Component
Specifications
Lunar iDXA Scanner table Full Size Table Lunar PRODIGY Advance, PRODIGY Primo, Scanner table *
Full Size Table Compact Table Lunar P RODIGY, PRODIGY Pro Scanner table*
Dimensions:287 cmx 131 cmx 125 cm(L x Wx H) Weight:appro ximately 360 kg Maximum patient weight supported:20 4 kg (450 pounds)
Dimensions:262.3 cmx 109.3 cmx 128.3 cm(L x Wx H) Weight:appro ximately 272.16 kg Maximum patient weight supported:15 9 kg (350 pounds): Dimensions:201 cm x 109.3 cm x 128.3 cm (Lx Wx H) Weight:appro ximately 254 kg Maximum patient weight supported:15 9 kg (350 pounds):
Full Size Table
Dimensions:262.3 cmx 109.3 cmx 128.3 cm(L x Wx H) Weight:appro ximately 272.16 kg Maximum patient weight supported:15 9 kg (350 pounds):
Compact Table
Dimensions:201 cm x 109.3 cm x 128.3 cm (Lx Wx H) Weight:appro ximately 254 kg Maximum patient weight supported:15 9 kg (350 pounds):
Lunar DPXPro/NT/MD+ Scanner table *
Full-size table
Dimensions:242 cmx 103 cmx 128 cm(L x Wx H) Weight:appro ximately 272 kg Maximum patient weight supported:13 6 kg (300 pounds)
Compacttable
Dimensions:181 cmx 103 cmx 128 cm(L x Wx H) Weight:appro ximately 254 kg Maximum patient weight supported:13 6 kg (300 pounds)
DPX Duo
Dimensions:186 cmx 86 cmx 147 cm(L x Wx H) Weight: appr oximately 275 kg Maximum patient weight supported:15 9 kg (350 pounds):
Dimensions:186 cmx 86 cmx 130 cm(L x Wx H) Weight: appr oximately 202 kg DPX Bravo Maximum patient weight supported:15 9 kg (350 pounds) Cons ole table 7 8.5 cm x 63.3 cm x 48.1 cm *Depthis measured fromthe frontedgeof thescanner table to the backedgeof thescanner arm. Heightis measured fromthe top of the scanner arm to the bottomof thescanner arm.
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Functional Specifications General specifications
iDXA: PRODIGY, PRODIGY Advance, PRODIGY Primo, PRODIGY Pro: DPX-Pro/NT/MD+: DPX-Duo/Bravo:
Focal spot to detector distance (cm)
Focal spot to pad surface distance (cm)
Focal spot to table top distance (cm)
Focal spot to source collimator distance (cm)
71.5
24.5
22
19
67.2
24.8
22.3
19
57.1 57.1
14.9 16.2
12.4 13.7
7.25 7.25
Lunar iDXA Maximum scan area (long x transverse) q q q q q
AP Spine Measurements: 39.5 cm x 22 cm Femur Measurements: 20.5 cmx 18 cm TotalBody Measurements: 197.5 cm x 66 cm measurementfield Forearm Measurements: 39 cm x 15 cm Lateral SpineMeasurements: 55.3 cm x 22 cm
Lunar PRODIGY, PRODIGY Advance, PRODIGY Primo, PRODIGY Pro Maximum scan area (long x transverse) q q q q q
AP Spine Measurements: 40.9 cm x 22 cm Femur Measurements: 20.9 cmx 18 cm TotalBody Measurements*: 197.5 cm x 60 cm measurementfield Forearm Measurements: 40.9 cm x 10 cm Lateral SpineMeasurements**: 40.9 cm x 22 cm
Lunar DPX-Pro/NT/MD+/Duo/Bravo Maximum scan area (long x transverse) q q q q q
AP Spine Measurements: 40.9 cm x 22 cm Femur Measurements: 20.9 cm x 17.9 cm TotalBody Measurements*: 195 cm x 60 cm measurementfield Forearm Measurements: 40.9 cm x 10 cm Lateral SpineMeasurements**: 40.9 cm x 22 cm
* Prodigy, DPX-Pro/NT/MD+ Fulls ize tables only ** Prodigy, DPX-Pro/NT/MD+ tables only
Software Features Depending on thescanner modeland number of options you purchased, notall of the softwarefeatures listed below may be included with your software: q q q q q q q q q q q q q q q q
AP spine measurementand analysis Pediatric spine measurementand analysis OneScan measurementapplication QuickView measurement application Femur measurement and analysis DualFemur measurement and analysis Total body measurementand analysis. Total body and regionaltissuequantitation Pediatric total body measurementand analysis Pediatric Femur measurementand analysis Forearm measurementand analysis Lateral spine measurementand analysis Dual-energy Vertebral Assessment: (Lateral and AP) Spine Geometry Orthopedic femur measurementand analysis (with extended Gruen Analysis) Hand measurement and analysis
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q q q q q q q q q q
Smallanimaltotalbody measurement and analysis ScanCheck™ (formerly known as Computer Aided Densitometry) Composer Reporting Tools PracticeManagementTools DICOMa nd HL7 interface capability SQL Server application TeleDensitometry Multi-user database capability OneVision capability AHA- HipStrength Analysis
Environmental Specifications Operational Environment Adhereto the specifications that follow during scanner operation: q
Ambient Space (Interior Subcomponents) - For scanner operation and servicing,do not block thearea around the
scanner table. Make sure thereis a minimum clearanceof 30.5 cm (24 cm for iDXA)at thehead and footends ofthe scanner table, at least15.2 cm for thearm side, and 45.7 cmfor theoperator side. q
Ambient Space (Ventilation) - Do not block thecooling vents on thecomputer and scanner table. Make sure thereis
15.2 cm from theconsole tableto thewall for cableclearanceand computer plugs. q
Dust, Fumes and Debris - Install the systemin a clean, ventilated area. Dustand other airborne debris can cause the
diskette drive heads and other sensitivemechanical components to malfunction. GE MEDICAL SYSTEMSr ecommends that you do not smokein thescanner room. q
Humidity - Make surethe humidity for thescanner areais 20%-80%,non-condensing.
q
Power Consumption - TheiDXA scanner requires a dedicated 20A 100-127 VAC+10%, 10A 200-240 VAC +10% circuit,
(singleduplex outlet)with isolated ground,THD<5%750VA. Theoutletshould be located behind theHostPC. TheLunar iDXAscanner willdraw 40VAwhen idle and less than 750VAduring a patient scan(100kV / 2.5mA). See Declarations of Immunity and Emissions table for power quality guidance. The Prodigy Series, DPX-Pro/NT/MD+/Duo/Bravo scanners requirea dedicated 100-240 VAC - 20A 100-120 VAC,10A 220-240 VACcircuit, (singleduplex outlet)with isolated ground,THD<5% 600VA. Theoutlet should belocated behind the HostPC. TheLunar PRODIGYand PRODIGY Advancescanner willdraw 40 watts when idle and approximately 450 watts during a patient scan (76kV / 3mA). The Lunar DPX-Pro/NT/MD+ scanner willdr aw approximately25 watts when idleand 250 watts during a patient scan (76 Kv / 1.5mA). TheLunar DPX Duo or DPX Bravo scanner willdraw 40 watts when idle and approximately 450 watts during a patient scan (76kV / 1.5mA). TheHost PC (typicalPC with a 17"monitor) will draw approximately110 watts when powered on. q
Distortion - Sinusoidal waveform, less than 5% THD
q
Heat Output - TheLunar iDXAscanner will outputapproximately150 BTU per hour when idle and 1500 BTU per hour
when actively scanning. TheLunar PRODIGYand PRODIGY Advancescanner willoutput150 BTU per hour when idle and 1500 BTU per hour when actively scanning. The Lunar DPX-Pro/NT/MD+/Duo/Bravo scanner willoutput 90 BTU per hour when idle and approximately 900 BTUper hour when actively scanning.The HostPC (PCwith 17"monitor) will outputapproximately400 BTUper hour when powered on. q
Static Electricity - Install and operatethesystem in a static-free area. Adhere to minimum humidity requirements to pre-
ventmalfunctions caused by static electricity. q
Shock and Vibration - Make sure the scanner table does notreceiveshockgreater than 1G for more than 1 millisecond.
Makesur e thescanner table does not receivevibrations greater than 0.25 G at 1-100 Hz.
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q
Temperature - Make sure thetemperature duringsystem operation is 65°F-81°F(18°C-27°C). NOTE: When thescanner is turned offfor more than an hour, or there is a power failure,you mustturn the systemon and
let itwarm for one hour.After onehour, completea Quality Assuranceprocedure.
Storage and transport environment Adhereto thes pecifications thatfollow for scanner storage and transportation: q
Humidity,0% to 95% non-condensing.
q
Atmosphericp ressure, 500 to 1060 hPa.
q
Temperature,-30° to 65° C.
Power Specifications Leakage current Computer and peripherals with Isolation Transformer:<1 00 microamperes. Scanner Table alone:<500 microamperes.
Scanner input power iDXA Thescanner has rated inputof 100-127 or 200-240 VAC, 50-60 Hz, 750VA. Voltagemay fluctuate ±10% fromthe rated input without a loss of scanner performance.The input power must meet IEEE519-1992 for power quality and total harmonic distortion (THD< 5%).
Lunar PRODIGY Primo, PRODIGY Advance, PRODIGY systems no. DF+12000 and higher, DPXPro/NT/MD+ systems no. 72000 and higher or 90000 and higher, DPX Duo, DPX Bravo Thescanner has a rated inputof 100-240 VAC (100-120 for US, Canada). Voltagemay fluctuate ±10% fromthe rated input without a loss of scanner performance.The input power must meet IEEE519-1992 for power quality and total harmonic distortion (THD< 5%).
Lunar PRODIGY systems no. DF+11999 and lower, DPX-Pro/NT/MD+ systems number 70000-71999 Thescanner has 4 different nominal inputs:100, 115, 230,and 240 VAC.During installation, thescanner is configured for thenominalinputwhich bestmatches the voltage on site. Voltagemay fluctuate ±10% fromthe nominal value withouta loss of scanner performance.The nominal input(rangeof inputs)can befound on thesystemlabel. Theinputpower must meetIEEE 519-1992 for power quality and total harmonicdistortion (THD <5%).
Scanner output power Lunar PRODIGY systems no. DF+11999 and lower, DPX-Pro/NT/MD+ systems number 70000-71999 Thescanner has 3 different nominal outputs: 100, 120,240 VAC. Thenominal voltage outputof the scanner is shownon thesystem label. The computer and all peripherals which use thescanner output power must be rated for this voltage. The maximum power outputis 400 VA.
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GE MEDICAL SYSTEMS X-Ray Tube Head Assembly Reference Axis and Target Angles for Tube Head Assembly - iDXA
iDXA Insert Specifications Manufacturer Model Nominal x-ray tube voltage
Lohmann X-ray GmbH 110/3 EFK 110 kV
Nominal anode input power
330 W
Maximum anode heat content
50 kJ
Anode target material
(W) Tungsten
Target angle
10°
Nominal focal s pot values
0.4 I EC 60336
Actual focals pot dimensional limits. Length parallel to LongitudinalAxis of X-RayTube Head Assembly
Width 0.25 mm to 0.42 mm Length 0.60 mm to 0.85 mm 0.55 mm of Aluminum equivalent
Inherent filtration
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EN606 01-2-28 6.8.3 aa) EN 60601-2-28 6.8.3 aa) EN 60601-2-28 6.8.3 aa) 6) EN 60601-2-28 6.8.2 aa) 1) EN 60601-2-28 6.8.2 aa) 2) EN 60601-2-28 6.8.3 aa) 1) EN 60601-2-28 6.8.3 aa) 3) EN 6 0601-2-28 6.8.3 aa) 4)
EN606 01-2-28 6.8.3 aa) 5)
Reference Axis and Target Angles for Tube Head Assembly - Prodigy Series, DPXPro/NT/MD+/Bravo/Duo
GE Medical Systems 8022 X-ray tube techn ical information Nominal anode input power Maximum anode heat content Anodeheating and cooling curves
Anode target material Reference axis Target angle 78° Nominal focal spot values Maximum useful voltage Maximum filament current
361 Watts 18300 Joules Refer to ProdigySeries, DPXPro/NT/MD+/Bravo/Duo Anode heating/cooling curves Tungsten Refer to reference axis figure (reference to normal) 0.5 95 kVp 2.2
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IEC 613/1989 IEC 613/1989 IEC613/1989
IEC 601-2-28 IEC601-2-28 IEC 601-2-28 IEC 336/1982 Not Applicable Amperes Not Applicable
Anode heating/cooling curves iDXA
Prodigy Series, DPX-Pro/NT/MD+/Bravo/Duo
Filament emission characteristics - Prodigy Series, DPX-Pro/NT/MD+/Bravo/Duo
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Filament emission characteristics - iDXA
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X-ray tube assembly heating/cooling curves iDXA12
1. Total energy inputwith cooling - actual heat contentis lower 2. Energy contentvalues shown are taken fromheating curve and represent actual stored energy contentwhich is lower.
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Prodigy Series, DPX-Pro/NT/MD+/Bravo/Duo
Compatible Components For customers located internationally, makes ure thecomputer is certified to localr equirements. v. 13 is compatiblewith existing Windows XP OS, however, for new DXA units,the computer must meet theminimum requirements thatfollow:
Prodigy Series, DPX-NT/Pro/MD+/Duo/Bravo Bone Densitometer configuration - Windows XP q q q q q q q q q
q q
Greater than 1 GHz processor 1 GBRAM Greater than 80 GB Hard Disk CD-RW/DVD-R 17"SVGA monitor with at least1024x768x32-bit color Audio capablewith speakers or monitor (with speakers) ServicePack 3 Internet Explorer version 7.0 Full heightPCI slotfor fastSerial I/O board (GEMedical Systems part number 7151) - Prodigys only with systemnumbers less than 300101 HP 2280, 2300,5650, KD5400, 8000 or equivalentprinter Media for archive and backup
Prodigy Series, DPX-NT/Pro/MD+/Duo/Bravo Bone Densitometer configuration - Windows Vista q q q q q q q q q
Greater than 1 GHz processor 2 GBRAM Greater than 80 GB Hard Drive (40 GBdrivefor OS partition and 15 GB free to install) CD-RW/DVD-R 17"SVGA monitor with at least1024x768x32-bit color Audio capablewith speakers or monitor (with speakers) ServicePack 1 Internet Explorer version 7.0 Full heightPCI slotfor fastSerial I/O board (GEMedical Systems part number 7151) - Prodigys only with systemnumbers less than 300101
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q q
HP 5650, KD5400, 8000 or equivalent printer Media for archiveand backup
iDXA Bone Densitometer configuration - Windows XP q q q q q q q q q q q
Greater than 2.8 GHz processor 2 GBRAM Greater than 80 GB Hard Disk CD-RW/DVD-R 17"SVGA monitor with at least 1024x768x32-bitcolor Audio capablewith speakers or monitor (with speakers) ServicePack 3 Internet Explorer version 7.0 2 100 Mbit ethernet connectivity HP 2280, 2300, 5650, KD5400, 8000 or equivalentprinter Media for archiveand backup
iDXA Bone Densitometer configuration - Windows Vista q q q q q q q q q q q
Greater than 2.8 GHz processor 2 GBRAM Greater than 80 GB Hard Drive (40 GBdrivefor OS partition and 15 GB free to install) CD-RW/DVD-R 17"SVGA monitor with at least 1024x768x32-bitcolor Audio capablewith speakers or monitor (with speakers) ServicePack 1 Internet Explorer version 7.0 2 100 Mbit ethernet connectivity HP 5650, KD5400, 8000 or equivalent printer Media for archiveand backup
FDA Certified Components The following givecomponents certified to theFDA for use with Lunar iDXA scanners. The tables areupdated periodically. Contact GE MedicalSystems Lunar for a currentlisting of compatiblecomponents.
Lunar iDXA Component
Description
GE Medical Systems Lunar Model #
Tube Head Assembly
GEMedical Systems Lunar iDXAX-RayTubeHead Assembly GE MedicalSystems Lu nar iDXAX-rayCon troller GE MedicalSystems Lu nar iDXACollimator Assembly
LU40782
X-raycon troller Collimator
LU41718 LU42129
The following givecomponents certified to theFDA for use with Lunar PRODIGY,PRODIGY Advanceand PRODIGY Primo scanners. The tables are updated periodically. ContactGE Medical Systems Lunar for a currentlisting of compatiblecomponents.
Lunar PRODIGY Advance PA+/- 301000 and higher, PRODIGY DF+/- 301000 and higher, PRODIGY Primo Component
Description
GE Medical Systems Lunar Model #
X-rayCon troller High Voltage Power Supplies TubeHead Assembly Collimator
GE MedicalSystems Lu nar sin gleboard controller Bertan 1 Model: 290 7 Spellman2 Model: SBD40PN280X2890
41170 7681 7681
GEMedical Systems Lunar X-Ray TubeHeadAssembly GEMedicalSystems Lunar PRODIGYCollimator Assembly 1BertanHigh Voltage Corp., 121 New South Road,Hicksville, NY 2Spellman High Voltage Electronics Corp., 475 Wireless Boulevard, Hauppauge, NY
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8743 8915
Lunar PRODIGY Advance PA+/- 40000-141999, PRODIGY Pro, PRODIGY DF+/- 12000-130999 Component
Description
GE Medical Systems Lunar Model #
X-rayCon troller High Voltage Power Supplies TubeHeadAssembly Collimator
GE MedicalSystems Lu nar sin gleboard controller Bertan1 Model: 2907 Spellman2 Model: SBD40PN280X2890
7635 7681 7681
GEMedical Systems Lunar X-Ray TubeHead Assembly GEMedicalSystems Lunar PRODIGYCollimator Assembly 1BertanHigh VoltageCorp.,121 New South Road,Hicksville,NY 2Spellman High Voltage Electronics Corp., 475 Wireless Boulevard, Hauppauge,NY
8743 8915
Lunar PRODIGY DF+/- 11999 and lower Component
Description
GE Medical Systems Lunar Model #
X-ray Controller
GE Medical Systems Lunar PRODIGY singleboar d controller High VoltagePower Su pplies Spellman1 Models: PTV40N200X2113 PTV40P200X2112 Bertan2 Models: 2411 N 2411 P Tub e Head A ssembly GE Med ical Systems Lunar X -Ray T ub e Head Assembly Collimator GE Medical Systems Lunar PRODIGY Collimator Assembly 1Spellman High Voltage Electronics Corporation Hauppauge,NY 2BertanHigh VoltageCorp.,121 New South Road,Hicksville,NY
5447
0311 0312 0311 0312 6838 6893
The following givecomponents certified to theFDA for usewith Lunar DPX-NT/PRO/MD+ scanners. The tables are updated periodically. Contact GE MedicalSystems Lunar for a currentlisting of compatiblecomponents.
Lunar DPX-NT/PRO/MD+/- 72000 and higher/90000 and higher Component
Description
GE Medical Systems Lunar Model #
X-rayController High Voltage Power Supplies TubeHeadAssembly
GEMedicalSystems Lunar singleboardcontroller Bertan1 Model: 2907 Spellman2 Model: SBD40PN280X2890
7634 7681 7681
GE Medical Systems Lunar X-RayTube Head 8548 Assembly Collimator GEMedicalSystems Lunar DEXACollimator 7767 Assembly 1BertanHigh VoltageCorp.,121 New South Road,Hicksville,NY 2Spellman High Voltage Electronics Corp., 475 Wireless Boulevard, Hauppauge,NY
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Lunar DPX-NT 70000-71999 Component
Description
GE Medical Systems Lunar Model #
X-ray Controller
GE Medical Systems Lunar DPX-NT singleboar d controller HighVoltagePower Supplies Bertan1 Models: 2411 N 2411 P Tu beHeadAssembly GE MedicalSystems Lu nar X-Ray Tube Head Assembly Collimator GE Medical Systems Lunar DEXA Collimator Assembly 1Bertan Associates, 121 New South Road, Hicksville,NY
7844
0311 or 8531 0312 or 8532 8297 2898
Lunar DPX Duo, DPX Bravo Component
Description
GE Medical Systems Lunar Model #
X-rayController High Voltage Power Supplies TubeHead Assembly
GEMedical Systems Lunar singleboardcontroller Spellman1 Model: SBD40PN280X2890
41500 7681
GEMedicalSystems Lunar X-RayTube Head 8548 Assembly Collimator GEMedicalSystems Lunar DEXACollimator 7767 Assembly 1Spellman High Voltage Electronics Corp., 475 Wireless Boulevard, Hauppauge, NY
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Index A
Ambient Space AP Spine Measurements Archive Image Files
36 35 30
C
Cautions Clean Scatter Table Environment Compatible Components Component Specifications
6 30 51 34
D
Dispose Materials
32 32
E
Electrical Safety Electromagnetic Emergency Stop Button Environmental Specifications External Symbols
20 20 6, 8, 15, 19, 31 36 14
F
Facilities Failsafe Circuit FDA Certified Components Functional Specifications
8, 20 19 52 35
H
Heat Output Humidity
36 36
I
Image list Interior Subcomponents Internal Symbols Isodose
31 36 15 23
L
Label Laser Lateral Spine Measurements License Agreement Limited Software Warranty
30 7-8, 15, 19, 31 35 4 4
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M
Measure Patients Mechanical Safety
7 9
O
Operator Safety Osteophytes
8 6
P
Patents Patient Safety Position Power Off Power On Power Consumption Power Specifications Precautions Standard Operating Procedures Preventive Maintenance Push Emergency Emergency Stop button
7 9, 19 5-7, 15, 31 15 15 36 37 6 6 31 8, 19, 31 19 19
Q
QA
6, 31
R
Radiation Safety Officer
8
S
Safety Information Scanner Table Assembly Scatter Radiation Shut Down Shutter Open Software License Agreement Space Requirements Standard Operating Procedures Precautions Static Electricity System Safety
6, 14 7 23 7-8 8-9, 15, 19, 31 8-9, 15 4 32 6-7 6 36 8
T
Technical Specifications Test Emergency Stop Button Total Body Measurements
4 31 31, 35
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