Edge Ultrasound System Wartungshandbuch

iService Manual

2 Chapter 1: Introduction Labeling symbolsThe following symbols are used on the products, packaging, and containers.Table 1: Labeling SymbolsSymbol D

Chapter 1: Introduction 3ManufacturerDirect Current (DC)Do not get wet.Do not stack over 2 high.Do not stack over 5 high.Do not stack over 10 high.

4 Chapter 1: Introduction Serial number type of control numberTemperature limitationAtmospheric pressure limitationHumidity limitationSubmersible. Pr

Chapter 2: Specifications 5Chapter 2: SpecificationsThis chapter contains information regarding system specifications and accessory compatibility.

6 Chapter 2: Specifications Battery specificationsThe battery is comprised of six lithium-ion cells plus electronics, a temperature sensor, and batte

Chapter 2: Specifications 7Black & white printer power cable— 3.3 ft/1 mBlack & white printer USB cable— 10.8 ft/3.3 mColor printer P13983

8 Chapter 2: Specifications

Chapter 3: Safety 9Chapter 3: SafetyThis chapter contains electrical and clinical safety information required by regulatory agencies. The informati

10 Chapter 3: Safety WARNING:To avoid the risk of electrical shock and fire hazard:• Inspect the power supply, AC power cords, cables, and plugs on a

Chapter 3: Safety 11Electrical safety classificationEquipment safetyTo protect your ultrasound system, transducers, and accessories, follow these p

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12 Chapter 3: Safety Battery safetyTo prevent the battery from bursting, igniting, or emitting fumes and causing personal injury or equipment damage,

Chapter 3: Safety 13Clinical safetyHazardous materialsWARNING:Non-medical (commercial) grade peripheral monitors have not been verified or validate

14 Chapter 3: Safety Electromagnetic compatibilityThe ultrasound system has been tested and found to comply with the electromagnetic compatibility (E

Chapter 3: Safety 15Separation distanceRecommended separation distances between portable and mobile RF communications equipment and the Edge ultras

16 Chapter 3: Safety Guidance and manufacturer’s declarationThe Edge ultrasound system contains an IEEE 802.11 transmitter that utilizes the ISM freq

Chapter 3: Safety 17SurgeIEC 61000-4-5±1KV line(s) to line(s)±2KV line(s) to earth±1KV line(s) to line(s)±2KV line(s) to earthMains power quality s

18 Chapter 3: Safety FCC Caution: Changes or modifications not expressly approved by the party responsible for compliance could void the user’s autho

Chapter 3: Safety 19Immunity testing requirementsThe Edge ultrasound system complies with the essential performance requirements specified in IEC 6

20 Chapter 3: Safety Biocompatibility standardsAAMI/ANSI/ISO 10993-1, Biological evaluation of medical devices—Part 1: Evaluation and testing (2009).

Chapter 4: System Overview 21Chapter 4: System OverviewAbout the SystemThe SonoSite Edge high-resolution ultrasound system is a portable, full feat

iiiSonoSite, Inc.21919 30th Drive SEBothell, WA 98021-3904USATelephone: 1-888-482-9449 or 1-425-951-1200Fax: 1-425-951-1201SonoSite LtdAlexander Ho

22 Chapter 4: System Overview Theory of OperationThe Edge ultrasound system has seven (7) major functional groups: •Transducer•Acquisition Subsystem•

Chapter 4: System Overview 23The Display Subsystem converts the detected ultrasound data into picture elements (pixels). The software user interfac

24 Chapter 4: System Overview Color Doppler (Color)In color Doppler, a real-time, two-dimensional cross-section of blood flow is displayed. The 2D cr

Chapter 4: System Overview 25Additional System Feature PerformancesPulsed Wave (PW) DopplerPW provides a real-time representation of blood flow and

26 Chapter 4: System Overview Front End OverviewThe Front End is designed to support various imaging modalities such as 2D, M-Mode, Spectral Doppler

Chapter 4: System Overview 27The number of elements driven is determined by element sensitivity off axis and depth of field considerations. The wav

28 Chapter 4: System Overview PW Doppler ProcessingDoppler processing includes both audio processing which presents Doppler signal in the form of ste

Chapter 4: System Overview 29CW Doppler ProcessingCW Doppler data will be presented to the signal processor as complex (I/Q) data from the analog f

30 Chapter 4: System Overview Back End OverviewThe Back End subsystem is responsible for the conversion of raw acquisition data into a raster image r

Chapter 4: System Overview 31Control SubsystemThe Edge Control Subsystem is shown in the figure below.Figure 4.6 Control Subsystem Block DiagramThe

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32 Chapter 4: System Overview Power Supply and ControlThe Edge Power Supply and Control System consists of an easily replaced rechargeable battery pa

Chapter 4: System Overview 33Battery Pack (VBAT)A rechargeable lithium-ion battery pack will be used to operate the unit in battery mode. The pack

34 Chapter 4: System Overview ECG ModuleThe ECG module allows a representation of the heart electrical activity to be displayed in real time with ult

Chapter 5: Troubleshooting 35Chapter 5: TroubleshootingThis chapter contains information to help you correct problems with system operation.System

36 Chapter 5: Troubleshooting Failure (Assert) CodesThe system displays an “assert screen” for hardware and software issues related to Main PCBA fail

Chapter 5: Troubleshooting 37DICOMTable 5.2: DICOM TroubleshootingError Message Tiller Error Code Cause TroubleshootingSocket communication failedT

38 Chapter 5: Troubleshooting

Chapter 6: Replacement Procedures 39Chapter 6: Replacement ProceduresCaution:Always use correct ESD procedures. ESD damage is cumulative and may no

40 Chapter 6: Replacement Procedures Figure 6.1 System Bottom3 AfterremovingtheEDGEBottomEnclosure, removethetwoscrewslocatedinFigure 6.2

Chapter 6: Replacement Procedures 41Figure 6.3 System Control Panel View5 Remove the 10 perimeter screws holding the Control Panel, carefully lift

vTable of ContentsIntroduction... 1Audience . . . . . . . . .

42 Chapter 6: Replacement Procedures Figure 6.5 Hinge CoverCaution:When lifting the front edge of the Control Panel away from the Main Frame, lift un

Chapter 6: Replacement Procedures 43Figure 6.7 Display ScrewsDisplay ReplacementDisplay Replacement1 Set the new Display Assembly in place.2 Instal

44 Chapter 6: Replacement Procedures Control Panel Subassembly ReplacementRequired PartsOne of the following: Required Tools• #1 Phillips screwdriver

Chapter 6: Replacement Procedures 45Control Panel ReplacementControl Panel Replacement 1 Place the new Control Panel onto the EDGE frame and line

46 Chapter 6: Replacement Procedures • Nest Frame Assembly, M-Turbo (Compatible with EDGE system):• P07750 Nest Frame Assembly• P00364 Connector, Int

Chapter 6: Replacement Procedures 47Speaker ReplacementRequired Part• P03872 Speaker AssemblyCaution:Use caution when removing the left speaker con

48 Chapter 6: Replacement Procedures Power Supply PCBA ReplacementRequired Part• P08850 Service Assembly, Power Supply, M-Turbo (Compatible with the

Chapter 6: Replacement Procedures 49SD Card Daughter-cardRequired Parts• P10168 SD Card, 2GB (4 required)• P07442 SD Card Daughter-cardSD Card Daug

50 Chapter 6: Replacement Procedures USB Extension PCB Assembly ReplacementRequired Part• P14727 USB Extension PCB AssemblyUSB Extension PCB Assembly

Chapter 6: Replacement Procedures 51Figure 6.15 Main PCBA Screws5 Turn the system over.6 Remove the 4 Socket Head Cap Screws as shown in Figure 6.1

vi Troubleshooting... 35System and Subsystem Diagnosis. . . . . . . . .

52 Chapter 6: Replacement Procedures Main PCBA ReplacementReplace the Main PCBA by following the reverse of the removal procedure. Do not tighten all

Chapter 7: Maintenance 53Chapter 7: MaintenanceThis chapter contains information to help you properly care for the system, transducers, and accesso

54 Chapter 7: Maintenance Cleaning and disinfecting the ultrasound systemThe exterior surface of the ultrasound system and the accessories can be cle

Chapter 7: Maintenance 55Cleaning and disinfecting transducersTo disinfect the transducer and its cable, use the immersion method or the wipe metho

56 Chapter 7: Maintenance To clean and disinfect a transducer (immersion method)1 Disconnect the transducer from the system.2 Remove any transducer s

Chapter 7: Maintenance 57Cleaning and disinfecting ECG cablesTo clean and disinfect the ECG cable (wipe method)1 Remove the cable from the system.2

58 Chapter 7: Maintenance

Chapter 8: Performance Testing 59Chapter 8: Performance TestingOverviewTo obtain 2D images, SonoSite recommends using the Gammex 403GS Soft Tissue

60 Chapter 8: Performance Testing Basic Operational Tests2D Performance Tests2D Performance / Image QualityBasic System Operation Tests1 Verify that

Chapter 8: Performance Testing 61Axial Measurement AccuracyNote: Measurements must be performed while the image is frozen.Lateral Measurement Accur

vii2D Performance Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

62 Chapter 8: Performance Testing PenetrationThe penetration measurement is an integral part of the quality assurance program. Penetration is defined

Chapter 8: Performance Testing 63Color Power Doppler (CPD)MMode ImagingTissue Harmonic ImagingTest CPD 1 Connect any transducer.2 Press the Color k

64 Chapter 8: Performance Testing Pulsed Wave (PW) Doppler ImagingContinuous Wave (CW) Doppler ImagingImage Quality Verification Test/Livescan• Produ

Chapter 8: Performance Testing 65PrinterThe printer test is an optional test that requires a video printer and minidock to be connected to the syst

66 Chapter 8: Performance Testing

Appendix A: Replacement Parts 67Appendix A: Replacement PartsThe following tables contain all the field-replaceable parts for the EDGE ultrasound s

68 Appendix A: Replacement Parts Control PanelTable A.2: Control PanelPart Number DescriptionP15630 Warranty Service Assembly Control Panel, English,

Appendix A: Replacement Parts 69Main PCBA14253Table A.3: Main PCBAItem Part Number Description1 P15615P15617V15615V15617Service Assembly Main PCBA,

70 Appendix A: Replacement Parts Miscellaneous PartsTable A.4: Miscellaneous PartsPart Number DescriptionCables (images are not to scale)P02308 FFC,

Appendix A: Replacement Parts 71Other Electrical PartsP02312 Fan AssemblyP03872 Speaker AssemblyP14727 USB Extension PCB Assy P14742 Compression Co

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72 Appendix A: Replacement Parts Mechanical/Cosmetic PartsSee Note Bottom EnclosureNote: Contact SonoSite Technical Support if it is necessary to rep

Appendix A: Replacement Parts 73P15305 Hinge CoverP16156 Service Assembly, EDGE Top EnclosureP15304 Enclosure, Middle, Machined, EDGEP07885 Thermal

74 Appendix A: Replacement Parts Transducer Nest Frame AssemblyFigure A.1 Nest Frame PartsOrdering Replacement PartsTo order parts, contact SonoSite

Appendix B: Service Event Reporting 75Appendix B: Service Event ReportingThe Service Event Report provides information about product failures to th

76 Appendix B: Service Event Reporting Service Event Report FormService Event Report Instructions on reverse Service Type (check one) Parts Stat

Appendix B: Service Event Reporting 77Service Event Report InstructionsInstructions for completing the Service Event Report Sections highlighted in

78 Appendix B: Service Event Reporting Returning Products to SonoSiteYou will be asked to provide the following information:• Contact name and phone

79INDEXNumerics2D performance testsaxial measurement accuracy 61image quality 61lateral measurement accuracy 61penetration 62AALARA 13assert code 3

80 Hhumidity limits 5Iimagequality verification test 64review 65LLCD screenclean 54Mmain PCBAfailures 36main system disassembly 45middle machined en

81storage specificationsequipment 5subassembly replacement 35systemclean and disinfect 54measurement accuracy 61overview 21Ttemperature limits 5the

Chapter 1: Introduction 1Chapter 1: IntroductionBefore servicing the Edge Ultrasound System, please read this manual. The ultrasound system has mul

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