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EDGE Service Manual

1. CW Asic PCB DSP Amplifier Other Channel with same Delay Freq y LOI LO Gen Delay LOQ Master Clk A Q Q Q Q Wall Filter De Complex To Doppler LV A D Filter p dbi Processing A D ilter Sample Clock Amplifier Other Channel with same Delay Freq e LOI LO Gen Delay i LOQ Master Clk A Figure 4 4 CW Doppler Processing Function Block Diagram Chapter 4 System Overview 29 Back End Overview 30 The Back End subsystem is responsible for the conversion of raw acquisition data into a raster image ready for display The Back End subsystem also contains the video data path that supports generation of video comprising of the ultrasound image as well as graphics annotation Video generation of both standard composite interlaced video and progressive scan video is supported Most functionality is within the ASIC but the memory resources for acquisition memory and display memory are found in external memory components The conversion from PC type video to TV type video is also performed externally Control is received initially from the CPU to setup each functional block and afterward the hardware is completely data driven This control takes the form of programming setup registers inside the blocks and setting up scan conversion tables Each block provides temporary storage as required to buffer data and keep their respective processing pipelin
2. printer Acquisition Gr Bus Processing AO Bus Display subsystem subsystem pp subsystem Video gt User interface IrDA Li Control Control Bus subsystem Serial Bus Power subsystem Battery pack Display power e assembly Transducer od eo sa ED Pulser voltage Power adapter External power Figure 4 1 SonoSite Edge High Resolution Ultrasound System Block Diagram The Transducer elements convert the pulser voltage to acoustic energy during the transmit portion of the ultrasound acquisition cycle The elements convert the acoustic echo to voltage in the receive portion of the acquisition The voltage developed on the transducer elements is sensed by the acquisition subsystem The system transducers have 64 to 192 elements The Acquisition Subsystem consists of the beamformer and interface to the transducer The beamformer controls the timing of the transmit pulses to focus the acoustic beam The beamformer amplifies the low level received echos and controls the receive focusing The system beamformer transmits on up to 128 elements and receives on 64 elements The Processing Subsystem includes capabilities for interfacing with the beamformer and performing high speed processing The processing subsystem demodulates filters detects and compresses the signal supplied by the beamformer into display in
3. I Service Manual Bi SonoSite SonoSite Inc 21919 30th Drive SE Bothell WA 98021 3904 USA Telephone 1 888 482 9449 or 1 425 951 1200 Fax 1 425 951 1201 SonoSite Ltd Alexander House 40A Wilbury Way Hitchin Herts SG4 OAP UK T 44 1462 444800 F 44 1462 444801 Caution Federal United States law restricts this device to sale by or on the order of a physician Edge SiteLink SonoCalc SonoHD2 SonoMB SonoMBe SonoSite and the SonoSite logo are registered in some jurisdictions and unregistered trademarks owned by SonosSite Inc DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information Non SonoSite product names may be trademarks or registered trademarks of their respective owners The SonoSite ultrasound system s referenced in this document may be covered by one or more of the following U S patents 5722412 5817024 5893363 6135961 6203498 6364839 6371918 6383139 6416475 6447451 6471651 6569101 6648826 6575908 6604630 6817982 6835177 6962566 7169108 7449640 7534211 7549961 7588541 7591786 7604596 7643040 7686766 7694814 7727153 7740586 7804970 7809400 7819807 7841575 7849250 7867168 7883276 D456509 D461895 D509900 D538432 D544962 D558351 D559390 D591423 D592750 D592760 D625014 D625015 and by the following counterpart foreign patent
4. 37 Maintenance Periodic Maintenance 39 Cleaning and disinfecting is cee ee ee eee een I 39 Cleaning and disinfecting the ultrasound system 40 Cleaning and disinfecting transducers sells 41 Cleaning and disinfecting the battery 42 Cleaning tlie TOOTS WIC eos ss tee xm EM SUO GE E DR e dU rs desde dede eu ose 42 Cleaning and disinfecting ECG cables iss ss ccc ccc ss ss ss ss se Re e 43 Performance Testing ul 45 Recommend Test Equipment 45 Setting Up Pelforteance Tests isdie eed EE Eua end ee one EV Y ERU ERU SERE dor 45 Basic Operational Tests issie seed Ed dee SR Pe Teteres ER DERS ED ERG bebe enda des 46 2D Performance esto iis e EE rU TRU Ee deine DUE aa 46 2D Performance Image Quality llle 46 Axial Measurement Accuracy LL 47 Lateral Measurement Accuracy LL 47 unu me 48 Additional Performance Tests e crea see DEE GE EER ERG OOG EED DES DE SE E Ede ew 48 Color Doppler Gol BEEN 48 color Power Doppler EED sain SEE riadas 49 MEMOGA AA edna bens Tu EE ii concent 49 Tissue Harmonic Maging ss erts Re SES SE ER ERE EES EE OE PR Ph ee 49 Pulsed Wave PW Doppler Imaging 50 Continuous Wave CW Doppler Imaging III 50 Image Quality Verification Test Livescan sss 50 xia T CEDERE 5 Battery CF alli pita N N nied eo OE tia 51 te leed RETO 51 Replacement Parts B EA EE
5. Chapter 4 System Overview 23 Color In color Doppler a real time two dimensional cross section of blood flow is displayed The Doppler 2D cross section may be presented as a rectangle parallelogram trapezoid sector or a full Color circle depending on the particular transducer used The 2D cross section is presented as a full color display with various colors being used to represent the velocity both positive and negative of the blood flow echoes Often to provide spatial orientation the full color blood flow cross section is overlaid on top of the gray scale cross section of soft tissue structure 2D echo For each pixel in the overlay the decision of whether to display VCD gray scale echo information or a blended combination is based on the relative strength of echoes from the soft tissue structures and from the red blood cells A high pass filter wall filter is used to remove the signals from stationary or slowly moving structures Tissue motion is discriminated from blood flow by assuming that blood is moving faster than the surrounding tissue although additional parameters may also be used to enhance the discrimination The remaining signal after wall filtering may be averaged over time persistence to present a steady state image of blood flow distribution Variance information may also be displayed to provide information when large variance is observed in the velocity information Color Power In CPD a real time two
6. PW Doppler mode provides the clinician with the ability to obtain blood flow velocities about a spatial sample volume A burst of ultrasound with a known spectrum is transmitted by the system on the receive side the transducer receive echoes are amplified and range gated at the appropriate depth The signal is analyzed by a quadrature phase detector that establishes two receive channels to allow detection of flow direction These two channels are then analyzed by a fast complex Fourier transform FFT circuit to establish the spectrum of frequencies present in the echoes The data are displayed as spectrum frequencies with respect to time PW can be used alone but is normally used in conjunction with a 2D image for spatial reference The 2D image has a graphical line D line superimposed on the 2D image indicating where the M mode beam is located The sample volume position depth and size are also indicated on the D Line Additional System Feature Performances Broadband Imaging Tissue Specific Imaging Biopsy Guidance Measurement and Calculation Capabilities This ultrasound acquisition system uses high resolution broadband technology in the transmit pulsers transducer and receivers The receive path can capture and process signals over a wide spectrum from below 2 0 MHz to beyond 10 MHz For each application the transmit pulse is designed to produce an appropriate bandwidth For example in 2D grayscale imaging a wide band p
7. b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m FCC Caution Changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment This device complies with part 15 of the FCC Rules Operation is subject to the following two conditions This device may not cause harmful interference This device must accept any interference received including interference that may cause undesired operation 18 Chapter 3 Safety SonoSite Immunity testing reduirements The Edge ultrasound system complies with the essential performance requirements specified in IEC 6060 1 1 2 and IEC 6060 1 2 37 Results of immunity testing show that the Edge ultrasound system meets these requirements and is free from the following e Noise on a waveform or artifacts or distortion in an image or error of a displayed numerical value that cannot be attributed to a physiological effect and that may alter the diagnosis Display of incorrect numerical values associated with the diagnosis to be performed e Display of incorrect safety related indications e Production of unintended or excessive ultrasound output Production of unintended or excessive transducer assembly surface temperature e Production of unintended or uncontrolled motion of transducer assemblies intended for intra corporeal use Standards Electrical safety standards AAMI ANSI ES 6060
8. 1 m cable Black amp white printer USB 10 8 ft 3 3 m cable Color printer P13983 Color printer power cable 3 3 fU 1m Color printer video cable 6 0 ft 1 8 m ECG lead wires P14202 24 in 0 6 m ECG module P08501 5 8 ft 1 8 m Edge Dock P15078 Edge Stand P15800 Footswitch P14689 9 8 ft 3 0 m Petite mouse P14451 6 ft 1 8 m Power cord system POO848 USA 10 ft 3 m Power Supply Battery PO9823 6 8 ft 2 m Charger PowerPark P12822 Triple Transducer Connect P15922 USB wireless adapter P12046 Chapter 2 Specifications Chapter 2 Specifications SonoSite Chapter 3 Safety This chapter contains electrical and clinical safety information reduired by regulatory agencies The information applies to the ultrasound system transducers accessories and peripherals Electrical safety This system meets EN6060 1 1 Class l internally powered equipment requirements and Type BF and Type CF isolated patient applied parts safety requirements This system complies with the applicable medical equipment requirements published in the Canadian Standards Association CSA European Norm Harmonized Standards and Underwriters Laboratories UL safety standards See Standards on page 19 For maximum safety observe the following warnings and cautions WARNING To avoid the risk of injury do not operate the system in the presence of flammable gasses or anesthetics Explosion can result WARNING To a
9. 4804 Hoe aaa A EE SE RE 11 Service Event Report 63 Shipping Instructions nero RR OES EE WER ikier kintan iranis 66 shipping specifications 5 storage specifications seit len coe oc cae ne EE nee EO ET EE EER ON E 5 subassembly replacement 37 system clean and ASIME CE 2 2545 RO N OE EE LS TAS EE 42 measurement accuracy 49 A eae aa EE N OT EE OE ge 23 T temperature limits LL 5 TMEOL OTODEIANON erica silla EA BAD ES EA SEER DR ies ae 24 transducer clean and disinfect ee hrs a OR RR ESE EA Gie Re aaa 43 ole 4 43 U user guide conventions use 1 V fe see Biel d AAR AA i ie E EE ORE TE EE ru Ed 53 W warnings definition 1 67 68 Bi SonoSite P15644 01 LAMP
10. Assembly Control Panel French Edge P15632 Warranty Service Assembly Control Panel German Edge P15633 Warranty Service Assembly Control Panel Italian Edge P15634 Warranty Service Assembly Control Panel Spanish Edge P15635 Warranty Service Assembly Control Panel Russian Edge P15636 Warranty Service Assembly Control Panel Portuguese Edge P15618 Service Assembly Control Panel English Edge P15621 Service Assembly Control Panel French Edge P15622 Service Assembly Control Panel German Edge P15623 Service Assembly Control Panel Italian Edge P15624 Service Assembly Control Panel Spanish Edge P15625 Service Assembly Control Panel Russian Edge P15626 Service Assembly Control Panel Portuguese Edge Appendix A Replacement Parts E SonoSite Main PCBA Table A 3 Main PCBA Item 1 4 5 Not shown Part Number P15615 P15617 V15615 V15617 P08850 P09541 P10168 P07442 P09542 Description Service Assembly Main PCBA Edge Warranty Service Assembly Main PCBA Edge Vet Service Assembly Main PCBA Edge Vet Warranty Service Assembly Main PCBA Edge Note This part does not include the transducer nest frame assembly Those parts must be ordered separately if needed to complete the replacement of the Main PCBA Service Assembly Power Supply M Turbo compatible with Edge system Power Supply Shield 2GB SD Card 4 required SD Card Daughter card Power Supply Shield Cover Attaches to Item 3 P
11. EE EE EE N EE EE 53 COME Ol Parel ere eo AE OE RS GN SE AR SE DE DE OE AE N 54 MAIN PGB ER aed 55 Miscellaneous Parts sis oie ates CRUCES ER RARUS SS AU PERS ES 56 Transducer Nest Frame Assembly 60 Ordering Replacement Parts 60 Service Event Reporting Service Event Report Form 62 Service Event Report Instructions iss ss sesse cc ence tenet ehh 63 Returning Products to SonoSite iss ss ss eee eee eee EE EE EE EE Ee Ee ee 64 Shipping INSEFUCLONS eri teli ESSO AEREA 64 Bi Sonosite Chapter 1 Introduction Before servicing the Edge Ultrasound System please read this manual The ultrasound system has multiple configurations and feature sets All are described in this service manual but not every option may apply to your system System features depend on your system configuration transducer and exam type Refer to the Edge Ultrasound System User Guide for additional information regarding safety system controls operation capabilities and specifications This chapter also defines labeling symbols specifications and standards Audience The intended audience of this manual is properly trained field and in house service personnel Contact Information Questions and comments are encouraged SonoSite is interested in your feedback regarding the service manual If you encounter difficulty with the system use the information in this manual to help correct th
12. Electrical fast 2KV for power supply lines 1KV for input output lines Transient burst IEC 61000 4 4 Chapter 3 Safety Compliance Level 6 0KV contact 8 0KV air 2KV for power supply lines 1KV for input output lines Electromagnetic Environment Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Bi Sonosite Guidance and Manufacturer s Declaration Electromagnetic Immunity Continued The Edge ultrasound system is intended for use in the electromagnetic environment specified below The customer or the user of the Edge ultrasound system should assure that it is used in such an environment Immunity Test Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power Frequency Magnetic Field IEC 61000 4 8 Conducted RF IEC 61000 4 6 IEC 60601 Test Level 1KV line s to line s 2KV line s to earth gt 5 Ur 295 dip in Uy for 0 5 cycle 4096 Ur 6096 dip in Uy for 5 Cycles 7096 Ur 30 dip in Uy for 25 cycles gt 5 Ur 295 dip in Uy for 5S 3 A m 3 Vrms 150 kHz to 80 MHz Compliance Level 1KV line s to line s 2KV line s to earth gt 5 Ur 295 dip in Ur for 0 5 cycle 4096 Ur 60 dip in Ur
13. Phase Shift Keying DBPSK at 16 dB e IEEE 802 11g with Orthogonal Frequency Division Multiplexing OFDM at 13 dBm Guidance and Manufacturer s Declaration Electromagnetic Emissions The Edge ultrasound system is intended for use in the electromagnetic environment specified below The customer or the user of the Edge ultrasound system should assure that it is used in such an environment Emissions Test Compliance RF emissions CISPR 11 Group 1 RF emissions Class A CISPR 11 Harmonic emissions Class A IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Electromagnetic Environment The Edge ultrasound system uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The Edge ultrasound system Is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network which supplies buildings used for domestic purposes Guidance and Manufacturer s Declaration Electromagnetic Immunity The Edge ultrasound system is intended for use in the electromagnetic environment specified below The customer or the user of the Edge ultrasound system should assure that it is used in such an environment IEC 60601 Test Immunity Test y Level 6 0KV contact 8 0KV air Electrostatic Discharge ESD IEC 6 1000 4 2
14. WARNING The battery has a safety device Do not disassemble or alter the battery WARNING Charge the batteries only when the ambient temperature is between 0 and 40 C 32 and 104 F WARNING Do not short circuit the battery by directly connecting the positive and negative terminals with metal objects WARNING Do not touch battery contacts WARNING Do not heat the battery or discard it in a fire WARNING Do not expose the battery to temperatures over 60 C 140 F Keep it away from fire and other heat sources WARNING Do not charge the battery near a heat source such as a fire or heater WARNING Do not leave the battery in direct sunlight WARNING Do not pierce the battery with a sharp object hit it or step on it WARNING Do not use a damaged battery WARNING Do nct solder a battery WARNING The polarity of the battery terminals are fixed and cannot be switched or reversed Do not force the battery into the system WARNING Do not connect the battery to an electrical power outlet WARNING Do not continue recharging the battery if it does not recharge after two successive six hour charging cycles WARNING Do not ship a damaged battery without instructions from SonoSite Technical Support See Technical Support USA Canada on page 1 WARNING If the battery leaks or emits an odor remove it from all possible flammable sources WARNING Periodically check to make sure that th
15. ultrasound system as recommended below according to the maximum output power of the communications eduipment Separation distance according to freguency of transmitter Rated maximum m output power of Mp 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz atts d 1 2 JP d 1 2 P d 2 3 JP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 12 12 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note At 80 MHz and 800 MHz the separation distance for the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Chapter 3 Safety 15 16 Guidance and manufacturer s declaration WARNING Other equipment even equipment that complies with CISPR emission requirements can interfere with the Edge ultrasound system The Edge ultrasound system contains an IEEE 802 11 transmitter that utilizes the ISM frequency band from 2 412 to 2 4835 GHz and implements two methods of transmission e IEEE 802 11b with Complementary Code Keying CCK Differential Quaternary Phase Shift Keying DQPSK and Differential Binary
16. user guide Follow instructions for use Device complies with relevant Australian regulations for electronic devices Batch code date code or lot code type of control number Biological risk Device complies with relevant Brazilian regulations for electro medical devices Canadian Standards Association The C and US indicators next to this mark signify that the product has been evaluated to the applicable CSA and ANSI UL Standards for use in Canada and the US respectively Catalog number Collect separately from other household waste see European Commission Directive 93 86 EEC Refer to local regulations for disposal Corrugated recycle Dangerous voltage Date of manufacture Zi SonoSite Table 1 Labeling Symbols Continued Symbol C EL STERILEIR Se A ci Definition Manufacturer Direct Current DC Do not get wet Do not stack over 2 high Do not stack over 5 high Do not stack over 10 high Electrostatic sensitive devices Device complies with relevant FCC regulations for electronic devices Fragile Gel Sterilized using irradiation Sterilized using ethylene oxide Hot Device emits a static DC magnetic field Non ionizing radiation Paper recycle Chapter 1 Introduction Table 1 Labeling Symbols Continued Symbol IP X 7 IPX WARNING Connect Only Accessories and Peripherals Recommended by SonoSite Chapter 1 Introduc
17. 1 1 2005 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance CAN CSA C22 2 No 60601 1 Canadian Standards Association Medical Electrical Equipment Part 1 General Requirements for Safety CAN CSA C22 2 No 6060 1 1 08 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance IEC 60601 1 1988 International Electrotechnical Commission Medical Electrical Equipment Part 1 General Requirements for Safety IEC 60601 1 2005 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance IEC 60601 1 1 2000 Medical Electrical Equipment Part 1 1 General Requirements for Safety Section 1 1 Collateral Standard Safety Requirements for Medical Electrical Systems IEC 6060 1 2 37 200 1 International Electrotechnical Commission Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment IEC 60601 2 37 2007 Medical Electrical Equipment Part 2 37 Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment IEC 61157 International Electrotechnical Commission Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment EMC standards classification CISPR 11 International Electrotechnical Commission International Special Committee on Radio Interfere
18. A engine and a floating point unit Support for the ultrasound sub system consists of a scanhead interface scanhead mux control Communication interfaces consists of an Ethernet interface USB port two general purpose serial bus interfaces and the IIC bus The EDGE control architecture is an open architecture It supports functionality extension through the incorporation of the PCI bridge to the PCI bus Functionality may be added by adding to the PCI Bus Chapter 4 System Overview 31 Power Supply and Control The Edge Power Supply and Control System consists of an easily replaced rechargeable battery pack an On Off Key a standby power regulator digital analog display and transducer power supplies a power monitor and a power control system Operating current is drawn from the battery or an external AC DC Adapter which also contains circuitry for charging the battery A fan and provision for a temperature sensor are also included VEXT StandbyPower VSTBY Regulator Digital Power supplies Analog Power Supplies Powel Monitor and Control Display Power Supplies SH 5V SH 33V SH VPP Transducer Power Supplies Figure 4 7 Power Supply and Control Subsystem Block Diagram Chapter 4 System Overview Bi SonoSite Battery Pack VBAT A rechargeable lithium ion battery pack will be used to operate the unit in battery mode The pack will include a capacity monitoring circuit and any required pack protectio
19. Chapter 4 System Overview SonoSite Chapter 5 Troubleshooting This chapter contains information to help you correct problems with system operation System and Subsystem Diagnosis This section covers basic diagnostic and troubleshooting procedures you may follow if the system does not operate properly To diagnose system failures consult the referenced diagnostic figures that follow or SonoSite Technical Support Table 5 1 Troubleshooting Subassemblies and Diagnostic Figures Subassemblies Diagnostic Figures or Table DICOM Table 5 2 Display TBA Battery TBA Control Panel TBA System Repair The system is repairable through subassembly replacement or through replacement of parts as recommended by SonoSite Component level repair of Printed Circuit Board Assemblies is performed only at the SonoSite repair facility Replacement of board level components by unauthorized service facilities voids the SonoSite warranty Test Equipment Test equipment is not required for this troubleshooting section Troubleshooting test aids include an external monitor and a spare battery Chapter 5 Troubleshooting 35 Failure Assert Codes The system displays an assert screen for hardware and software issues related to Main PCBA failures Main PCBA failures typically result in assert codes that are output to the display If an assert screen appears note the assert information and contact SonoSite Technical Support to clarify the failure Fig
20. Connection of accessories and peripherals not recommended by SonoSite to the ultrasound system may result in malfunction of the ultrasound system or other medical electrical devices in the area Contact SonoSite or your local representative for a list of accessories and peripherals available from or recommended by SonoSite See the SonoSite accessories user guide Electrostatic discharge Caution 14 Chapter 3 Safety Electrostatic discharge ESD or static shock is a naturally occurring phenomenon ESD is common in conditions of low humidity which can be caused by heating or air conditioning ESD is a discharge of the electrical energy from a charged body to a lesser or non charged body The degree of discharge can be significant enough to cause damage to a transducer or an ultrasound system The following precautions can help reduce ESD anti static spray on carpets anti static spray on linoleum and anti static mats Bi SonoSite Separation distance Recommended separation distances between portable and mobile RF communications eduipment and the Edge ultrasound system The Edge ultrasound system is intended for use in an electromagnetic environment in which radiated radio frequency RF disturbances are controlled The customer or the user of the Edge ultrasound system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications eduipment transmitters and the Edge
21. Doppler From the Front End s perspective all modes can be grouped into a few basic types Single mode simultaneous modes and triggered modes All these modes are built from similar basic transmit and receive sequences controlled within the Front End A generic top level block diagram of a typical Front End is in the figure below Transducer Receive Section TGC mplifier Weight Lo Waveform Beamformed TGC Amplifier Weight te Waveform Control Transmit Section Figure 4 2 Front End Block Diagram The transmit section consists of a waveform generator delay block and high power high voltage driver to excite the transducer element Multiple elements are driven with delays determined by the time of flight in the medium from the elements to the point in space where the beam is to be focused The longer the time of flight is to the focal point the smaller the delay is for a given transmit element to allow all to arrive at the focal point at the same time Chapter 4 System Overview SonoSite The number of elements driven is determined by element sensitivity off axis and depth of field considerations The waveform is selected to drive the transducer at a certain center frequency bandwidth and power and is optimized for the given mode The receive section consists of a transmit receive s
22. E ee Ee ee 13 Electromagnetic compatibility ee Re Re mh 14 Electrostatic el en E lee susci x ei ESE ea EG DIE ER URS DANN GN TER 14 Separa ton distdltB ER ES EE P M ETT Se DE oe e Ne EUN EE NM Ed re ED 15 Guidance and manufacturer s declaration 16 Cer S 19 Electrical safety standards 19 EMC standards classification 20 Acoustic standardsS asian ropa card CU MN TII 20 BIOCOMPAalIDINITY E ne Ee EE 20 Airborne equipment standards 20 prae staridard NETTE SS ED Re TT TOIT DTE 20 HIPAA standaid as eni bee Ee E ES EO EP GE AD PEKIN QST UE RR PY 20 System Overview About the VEE or uei ME RE DAE ED ED ESE ER RED GE ENE nee GE GE Ee ee Ee dn oe da 21 oo occa menor o ER OE EE DE OE E EE Tre 22 Description of Operating Mode 23 Additional System Feature Performances 25 Front End OVET EW sd esse ESE diia ede de eo E ge dati ti d 26 PW Doppler Processing su PS ED EED DE OE dor dabo rr a GO EE 28 CW Doppler Proc ssind EE 29 A eee othe ote ee ae ee 30 COMO US Manada 31 Power Supply and Control 32 zecrun c2 O 34 DICOM 34 Vi Troubleshooting System and Subsystem Diagnosis 35 System Repair since ESRA ouod dene DE EA tee DASSE ATTI tt 35 TeSt E OUDEN TET T T T n ope 35 Failure Assert Code 36 Verifying a System Assert Code 36 DICOM
23. Environmental limits Note The temperature pressure and humidity limits apply only to the ultrasound system transducers and battery Operating system battery and transducer 10 40 C 50 104 F 15 9596 R H 700 to 1060hPa 0 7 to 1 05 ATM Mode of Operation Continuous 35 C or below Non Continuous above 35 C 30 minutes on 30 minutes off Shipping and storage system and transducer 35 65 C 31 149 F 15 95 R H 500 to 1060hPa 0 5 to 1 05 ATM Shipping and storage battery 20 60 C 4 140 F 15 9596 R H For storage longer than 30 days store at or below room temperature 500 to 1060hPa 0 5 to 1 05 ATM Electrical specifications Power Supply Input 100 240 VAC 50 60 Hz 2 0 A Max 100 VAC Power Supply Output 1 15 VDC 5 0 A Max Power Supply Output Z2 12 VDC 2 3 A Max Combined output not exceeding 75 watts Chapter 2 Specifications 5 Battery specifications The battery is comprised of six lithium ion cells plus electronics a temperature sensor and battery contacts Run time is up to two hours depending on imaging mode and display brightness This chapter contains electrical and clinical safety information required by regulatory agencies The information applies to the ultrasound system transducer accessories and peripherals Compatible accessories and peripherals SonoSite has tested the Edge ultrasound system with the following accessories and peripherals and has demonstrated co
24. Message Tiller Error Code Socket TSOCKET CONNECT FAILURE communication failed Archiver TDICARCH OPEN FAILURE transaction failed Printer TDICPRNT OPEN FAILURE transaction failed DICOM network TDNETWORK OPEN FAILURE communication failed Internal failure TDNETWORK READ FAILURE detected Cause Invalid network configuration Wrong port number Application is not running Printer is offline Wrong Capture Type selected Wrong Image settings Device does not recognize Edge rejects association Invalid DICOM Attribute Troubleshooting Using Ping verify that the Printer Archiver is connected If Ping fails checkthe devices IP address Edge IP address Subnet mask and Gateway IP address If Ping is OK use Verify to check if device is available If Verify fails a Check the Printer Archiver s Port configuration on the Edge b Ensure that the Printer is online and the Archiver s application is running Verify that the Archiver supports the selected Capture Type setting e g US Image SC Image or US Ret Image Verify that the printer supports the selected Image settings E g Color RGB or Grayscale Monochrome Verify that Edge AE Title or IP address is correctly configured on the Printer Archiver Note Some devices require that the Imaging modality Edge be recognized in order to accept images This requires configuration on the device Check Edge Printer DICOM setting
25. SHDB Version the software level of the failed device Typically found on the system information screen Configuration for configurable devices the optional features enabled Event Description e Adescription of the problem in the words of the user Typically what the user reports to the repair facility Diagnosis e A description of what the repair technician found Include a list of the suspect parts Service Performed e A description of the work performed to repair the system Typically only completed if it is repaired from stock repair parts Parts Removed e Part Name the name of the failed suspect part to be replaced Part Number the part number of the failed suspect part Serial Number the serial number from the failed suspect part Lot Number the lot number if applicable Rev the revision of the failed suspect part 1f available Replaced By the person replacing the part Parts Installed e The same information as the Parts Removed except from the parts installed if work has already been performed If you are waiting for parts to be ordered leave this section blank Tests Performed e The results of any testing performed if testing has already been performed Appendix B Service Event Reporting 63 Returning Products to SonoSite You will be asked to provide the following information e Contact name and phone number Product name Serial number Description of the problem Shipping Instructions Please contact Sono
26. Site to get a return material authorization number RMA Contact SonoSite before returning any product The shipping address for all returned products is SonoSite Inc Attn Technical Support RMA 21919 30th Drive SE Bothell Washington 98021 USA 64 Appendix B Service Event Reporting INDEX Numerics 2D performance tests axial measurement accuracy 0 00 49 Mage QUAY ENE N OE OE ear 49 lateral measurement accuracy 6 e 49 esi EE 50 A ALARA RO OE ET EO N OE da N N 13 ASSCIECO0E AAS E EE N EE TRE 38 assistance customer eee ehh l B battery A 44 cL AE AE EE ARE ER ab as 12 SDECHICAUONG ua send da ESE DEAL E SE RS des an etd dnd dnm od 6 battery charging test ise sb eb rhe he ea y ea ded Ed dd i wed wes 53 biological safety 13 C cables clean and disinfect ECG 45 CANONS delo AA eR ou tire SE TAE IPS Ra OE EE OE resp 1 clean A 44 E A 45 fere ire AAR ORR Sedans ae ge EE OE EE EE OE OE OE REEN 44 BABES AE ENE EE N EE EE EE EE N AO oe 42 cp n d 42 raris QU Pe RE een 43 cleaners recommended SS SS eee eee nee ee ee ee 4 D disinfect DAS RA ASA dhe EEEE 44 ECOICADI acaparado does aa yes 45 I ARIE SEE ENE O 42 HONSAUCENSssroncossa sfilata reni la lei 43 disinfectants recommended 0 0 0 cece eee nnn eens 4 E electrical SUIC A 9 SDCCIICAUONS AO SO OE Uhr OE OE OE EE OO EE 5 electrom
27. agnetic compatibility esl 14 equipment safety 11 error message navarros EE a da ES ONE 10 65 66 F Failure REDOING ee c 03 ERAS REK KUR DER WEES ER OER ASE ae ees 63 H Nr ebe MIS 42 oa pee eee OE ET N OE OE EE EN GE EE ED 5 image quality Verification test c iseer ok Ese se eed RE nO x eb Ex OE NIRE RR 52 gl 52 L LCD screen CICORIA 42 M main PCBA EI RA E ia ER OE oe 38 P performance tests yp EE NG NE EE AE OT EE FEE VA 48 cuc OASE RE EE EE ET EE ET NS OE EET OE EO EO 53 CPD ES ETER OE OE EER EO OER eee nas ON Ee 51 CW AT r 52 li dq Cc 51 a RE OE ES EE re EE ech 47 UE oaa one TE 53 PARTIRE 52 e EE EE 51 VOY COOP AA NE EE TE Had ero ER EN EE ead 50 WMOSO OUIDUE ARE AE AO N N EE E pe OE dra 53 periodic maintenance o 4 pressure limits EO pacer Y asd od dde EE dox b PEE cue 5 printer TOS p O K 53 PLOOUCE dI GS seine REED SRO SER RS Sy BOA DRR GR ia 63 R replacement parts I RE ET ET m 55 0 1 ele ege EE N E OR EE N ee ee EN 62 Return Material Authorization number IRMA 66 Returning Bd tee CEET 66 Bi SonoSite S safety CE AE DE ae Rea ah ess os N OR aoe NG EE RE E 12 alie ole es MORE EE NE ER OE EN ET EE EE 13 e AA EE NE OE EE OE EE IE 9 electromagnetic compatibility SS ee Se ee ee ee 14 equipment sessie Dei 404
28. aning methods listed are recommended by SonoSite for compatibility with product materials not for biological effectiveness Refer to the disinfectant label instructions for guidance on disinfection efficacy and appropriate clinical uses WARNING The level of disinfection required for a device is dictated by the type of tissue it contacts during use To avoid infection ensure that the disinfectant type and the solution strength and duration are appropriate for the equipment For information see the disinfectant label instructions and the recommendations of the Association for Professionals in Infection Control and Epidemiology APIC and the FDA WARNING To prevent contamination the use of sterile transducer sheaths and sterile coupling gel is recommended for clinical applications of an invasive or surgical nature Do not apply the transducer sheath and gel until you are ready to perform the procedure Caution Some transducer sheaths contain natural rubber latex and talc which can cause allergic reactions in some individuals Refer to 21 CFR 801 437 User labeling for devices that contain natural rubber Chapter 6 Maintenance 39 40 Cleaning and disinfecting the ultrasound system The exterior surface of the ultrasound system and the accessories can be cleaned and disinfected using a recommended cleaner or disinfectant WARNING WARNING WARNING Caution Caution Caution Caution Caution To avo
29. asurements must be performed while the image is frozen Set Up Axial 1 Acquire the image Measurement 2 Press the Freeze key Accuracy 3 Pressthe Caliper key The caliper appears on the image display See the Edge Ultrasound System User Guide if necessary for caliper operation Use the touchpad to position one of the calipers Press the Select key to fix the caliper and enable the other caliper Use the touchpad to move the other caliper The results update as you move the caliper and the measurement is complete when you finish moving the calipers Press the Select key to alternate the active caliper and adjust the measurement with the touchpad OU 4 Test Axial 1 Measure the distance center to center of any two pins that are 5 12 cm apart vertically Measurement 2 Verify that the distance measured is within the tolerance listed in Table 7 1 Accuracy Lateral Measurement Accuracy Set Up Lateral Perform Set Up Axial Measurement Accuracy on page 47 Measurement Accuracy Test Lateral 1 Measure the distance center to center of any two pins that are 4 10 cm apart horizontally Measurement 2 Verify that the distance measured is within the tolerance listed in Table 7 1 Accuracy 3 Pressthe Freeze key to return the system to live 2D mode Table 7 1 System Measurement Accuracy Measurements Tolerance Axial Distance 2 Lateral Distance 2 Chapter 7 Performance Testing 47 Penetration The penetration measure
30. digital bus In addition inter laced video is supplied in both composite and S video formats The progressive video path includes buffers priority logic and LUTs External video in signals are input and multiplexed onto the external video out path to allow for external sources to display information on connected displays VCRs or printers Chapter 4 System Overview SonoSite Control Subsystem The Edge Control Subsystem is shown in the figure below SYSPWR INFRASTRUCTURE SYSCLKS MASS SYSRST EXPANSION STORAGE A A ETHERNET 4 SYSTEM SYSTEM Y v FLASH RAM PCI BUS A A d 2 PCI BRIDGE DUAL UART d USB v Y SYSTEM BUS SH MUX SYSTEM IIC CONTROL FLOATING SH e TIMERS DMA POINT CONTROLLER CONTROL Y cache A o 5 ea INTERRUPTS gt D PROCESSOR Y ULTRASOUND nie a 8 GPIO SCANHEAD DATA PATH Y IIC BUS Figure 4 6 Control Subsystem Block Diagram FAST ETHERNET U I DEBUG USB DATA ADDRESS CONTROL VIDEO AUDIO ECG DATA CONTROL The core control subsystem contains the processor the system bus the system memory resources of FLASH and RAM the interrupt logic system timers a DM
31. dimensional cross section of blood flow is displayed The 2D Doppler cross section may be presented as a rectangle parallelogram trapezoid sector or a full CPD circle depending on the particular transducer used The 2D cross section is presented as a full color display with various colors being used to represent the power in blood flow echoes Often to provide spatial orientation the full color blood flow cross section is overlaid on top of the gray scale cross section of soft tissue structure 2D echo For each pixel in the overlay the decision of whether to display CPD gray scale echo information or a blended combination is based on the relative strength of echoes from the soft tissue structures and from the red blood cells A high pass filter wall filter is used to remove the signals from stationary or slowly moving structures Tissue motion is discriminated from blood flow by assuming that blood is moving faster than the surrounding tissue although additional parameters may also be used to enhance the discrimination The power in the remaining signal after wall filtering may be averaged over time persistence to present a steady state image of blood flow distribution Continuous CW provides a real time representation of blood flow and is displayed as a Wave CW velocity versus time sweeping output Velocity or frequency is presented as the vertical Doppler axis with time along the horizontal axis The magnitude of the detected s
32. dures For additional information see the biopsy user guides The system offers a variety of measurements and calculations specific to exam type and transducer A list of them and author references are in the system user guide Measurement accuracy is also discussed Chapter 4 System Overview 25 Continuous Wave The system provides for audio output of the CW velocity information This can be Doppler Audio presented as stereo information with flow moving towards the transducer on one Output channel and flow away on the other or as a mono output with the single audio output representing the summation of the flow directions Pulsed Wave Doppler The system provides for audio output of the PW velocity information This can be Audio Output presented as stereo information with flow moving towards the transducer on one channel and flow away on the other or as a mono output with the single audio output representing the summation of the flow directions Electrocardiograph ECG is provided to measure the electrical signal generated by the heart A three lead ECG Display interface Right Arm RA Left Arm LA and Left Leg LL is provided on the system The ECG signal is displayed as an amplitude versus time sweeping output Amplitude is presented on the vertical axis with time along the horizontal axis Front End Overview 26 The Front End is designed to support various imaging modalities such as 2D M Mode Spectral Doppler and Color
33. e battery charges fully If the battery fails to charge fully replace it Caution To avoid the battery becoming damaged and causing equipment damage observe Chapter 3 Safety the following precautions Do not immerse the battery in water or allow it to get wet Do not put the battery into a microwave oven or pressurized container If the battery emits an odor or heat is deformed or discolored or in any way appears abnormal during use recharging or storage immediately remove it and stop using it If you have any questions about the battery consult SonoSite or your local representative Store the battery between 20 C 4 F and 60 C 140 F Use only SonoSite batteries Do not use or charge the battery with non SonoSite equipment Only charge the battery with the system Bi SonoSite Clinical safety WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING Non medical commercial grade peripheral monitors have not been verified or validated by SonoSite as being suitable for diagnosis To avoid the risk of a burn hazard do not use the transducer with high frequency surgical eduipment Such a hazard may occur in the event of a defect in the high frequency surgical neutral electrode connection Do not use the system if it exhibits erratic or inconsistent behavior Discontinuities in the scanning sequence are indicative of a hardware failure that must be corrected befo
34. e cloth rather than the surface 4 Mix the disinfectant solution compatible with the system following disinfectant label instructions for solution strengths and disinfectant contact duration 5 Wipe surfaces with the disinfectant solution 6 Air dry or towel dry with a clean cloth Chapter 6 Maintenance SonoSite Cleaning and disinfecting transducers To disinfect the transducer and its cable use the immersion method or the wipe method WARNING To avoid electrical shock before cleaning disconnect the transducer from the system WARNING To avoid injury always use protective eyewear and gloves when performing cleaning and disinfecting procedures WARNING To avoid infection ensure that the solution expiration date has not passed Caution Transducers must be cleaned after every use Cleaning transducers is necessary prior to effective disinfection Ensure that you follow the manufacturer s instructions when using disinfectants Caution Do not use a surgeon s brush when cleaning transducers Even the use of soft brushes can damage a transducer Use a soft cloth Caution Using a non recommended cleaning or disinfection solution incorrect solution strength or Immersing a transducer deeper or for a longer period of time than recommended can damage or discolor the transducer and void the transducer warranty Caution Do not allow cleaning solution or disinfectant into the transducer connector Caution Do not all
35. e full and operating Also note that the block diagrams show only the data path but each block is responsible for generating any necessary memory addresses for their respective input data stream The Edge Back End subsystem is shown in the figure below FLASH ELIBPRE SEHH Ehel FAQEESSING is sk ELDERS ay PS VIDEO vib Bo PATH ita i co HANC BUTERA DE A e E RT r A CYES OUT H Ka Ex tannini LL CuBE IN Kl e d G tt falla a EES 7m T j s anea FLAM COVER EHO T Ba DUT hoed S VIDEO CONTROLLER acaip TO T vibo DDNTEDLLER AE ALT HI Dis PLAT MIL nud i228 Mk SDRAM Figure 4 5 Back End Subsystem Block Diagram The Back End Subsystem performs processing encompassing three main data domains acquisition data raster data and video data Support for acquisition data includes the input buffer flash suppression frame average and external ACO memory Cine buffer management is performed by the acquisition controller Conversion from acquisition data to raster data is performed by the graphics overlay scan conversion engine sweeping engine and 3D engine Raster data is stored in an external DISPLAY memory Also supporting raster operations is the graphics support block that provides acceleration hardware for pixel operations from the CPU and graphics over lay engine Video data is processed as progressive scan and supplied externally on a
36. e problem If the problem is not covered here contact SonoSite Technical Support as follows Technical Support USA Canada 1 877 657 8118 Technical Support fax 1 425 951 6700 Technical Support e mail service sonosite com SonoSite website www sonosite com Select Resources gt Support amp Service International Technical Support Contact your local representative or call USA 425 951 1330 European Service Center 44 0 1462 444 800 e mail uk service sonosite com Japan Service Center 81 3 5304 5337 Conventions symbols and terms The user guide follows these conventions A WARNING describes precautions necessary to prevent injury or loss of life A Caution describes precautions necessary to protect the products e Numbered steps in procedures must be performed in order e tems in bulleted lists do not require performance in sequence Chapter 1 Introduction 1 Labeling symbols The following symbols are used on the products packaging and containers Table 1 Labeling Symbols Symbol OO Chapter 1 Introduction Definition Alternating Current AC Class 1 device indicating manufacturer s declaration of conformance with Annex VII of 93 42 EEC Class 1 device requiring verification by the Notified Body of sterilization or measurement features or to a Class lla Ilb or Ill device requiring verification or auditing by the Notified Body to applicable Annex es of 93 42 EEC Attention see the
37. emove any particulate matter or body fluids Apply the solution to the cloth rather than the surface 4 Rinse with water or wipe with water dampened cloth and then wipe with a dry cloth 5 Mix the disinfectant solution compatible with the transducer following disinfectant label instructions for solution strengths and disinfectant contact duration 6 Immerse the transducer into the disinfection solution not more than 12 18 inches 31 46 cm from the point where the cable enters the connector Follow the instructions on the disinfectant label for the duration of the transducer immersion 7 Using the instructions on the disinfectant label rinse to the point of the previous immersion and then air dry or towel dry with a clean cloth 8 Examine the transducer and cable for damage such as cracks splitting or fluid leaks If damage is evident discontinue use of the transducer and contact SonoSite or your local representative Cleaning and disinfecting the battery Caution To avoid damaging the battery do not allow cleaning solution or disinfectant to come in contact with the battery terminals To clean and disinfect a battery wipe method 1 Remove the battery from the system 2 Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning solution Apply the solution to the cloth rather than the surface 3 Wipe the surfaces with the disinfection solution Sani Cloth HB Sani Cloth Wipes or 70 isoprop
38. erated from wall filtered data by phase shifting the in phase component PW Doppler Processing Function Block Diagram Peak amp Mean d Back Temporal Baseline Display End Averaging wompress shift Interpolate W OBP Peg Fo Resample Window Gain RF Audio Output indicates IQ pairs e Hilbert Audio MEM Phase Shifter Gan 2x16 bits PRF rate Audio Gain oO Q Figure 4 3 PW Doppler Processing Function Block Diagram 28 Chapter 4 System Overview Bi SonoSite CW Doppler Processing ieee pen CW Doppler data will be presented to the signal processor as complex I Q data from the analog front end of the external DSP The 16 bit data will be presented as consecutive samples at a data rate varying from 1 5 kHz to 64 kHz for the complex pair Most of CW processing is similar to that of PW except for the OBP function In place of OBP will be a low pass decimating filter that operates on incoming VO data The Doppler Processing block must allow storage of 128 undetected O pairs in to allow the system to measure and correct for phase mismatch Measuring and correcting will need to be accomplished in system software
39. erforms gain filter DC Offset and trigger functions The resultant data is output at either the 200Hz sample rate or decimates the data by 2 or 4 and outputs the data into acquisition memory The data is assumed to be signed The ECG trigger function is implemented by a simple edge sensitive trigger along with SW monitoring the ECG data and triggering the FE after a user defined delay from the detected R wave An interrupt is provided that will interrupt the processor after a set delay from the detected level and slope A simple block diagram of the HW is shown below D ata enmt Figure 4 9 ECG Block Diagram DICOM IMT 34 The system features Digital Imaging and Communications DICOM capability to provide the acceptance transfer display storage and digital processing of single ultrasound images as well as loops of ultrasound images The system includes the ability to measure the intima media thickness IMT of the carotid artery using digital ultrasound images The intima is that region of the arterial wall from and including the endothelial surface at the lumen to the luminal margin of the media The media layer extends from the intima to the adventitia of the vessel wall The adventitia is normally quite echogenic on ultrasound images when compared to the media The IMT measurement of the carotid artery may be used adjunctively with other medical data obtained by a physician to help assess the cardiovascular health of a patient
40. for 5 cycles 7096 Ur 3096 dip in U 7 for 25 cycles gt 5 Ur 295 dip in Uy for 5s 3 A m 3 Vrms Electromagnetic Environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the Edge ultrasound system requires continued operation during power mains interruptions it is recommended that the Edge ultrasound system be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Portable and mobile RF communications equipment should be used no closer to any part of the Edge ultrasound system including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance d 12JP Chapter 3 Safety 17 Guidance and Manufacturer s Declaration Electromagnetic Immunity Continued The Edge ultrasound system is intended for use in the electromagnetic environment specified below The customer or the user of the Edge ultrasound system should assure that it is used in such an environment i IEC 60601 Test Compliance Electromagnetic Immunity Test Level Level Environment Radiated RF 3 Vim 3 V m d 12JP d 2 3 JP 800 MHz to 2 5 GHz Where P is t
41. formation Chapter 4 System Overview SonoSite The Display Subsystem converts the detected ultrasound data into picture elements pixels The software user interface graphics are combined with the ultrasound information and converted to a video stream The external video port supports NTSC and PAL format The Control Subsystem consists of the central processing unit program and video memory permanent image storage and retrieval memory external communication interface ports and connection to the user interface keys The control software includes the acoustic power and intensity software subsystem power group monitors and a beamformer monitor This software guarantees a level of patient safety by ensuring the system is operating within acoustic power and intensity limits The User Interface Subsystem represents the software interface and form factor The software interface is the interaction between the user and the screen layout components The form factor is the type of physical buttons location and grouping of the buttons and the device size shape and weight Dedicated controls are for high usage activities and grouped according to the user workflow The Power Subsystem provides the system power and protects the hardware from destructive and or unsafe conditions by detecting failures in the system through hardware and software monitors Detection of a fault results in disabling of the pulser supply and signaling of an error to the Contro
42. he Gammex 403GS Soft Tissue Phantom or the Gammex 413A Multipurpose Phantom A 7db cm phantom is recommend but not required Some features and capabilities are optional and therefore may be unavailable to test Recommend Test Equipment SonoSite ultrasound system under test e C60x 5 2 MHz transducer e P21x 5 1 MHz transducer Gammex 403 GS Multipurpose Phantom 413A Soft Tissue Phantom or equivalent e Acoustic gel Setting Up Performance Tests Set up 1 Attach the C60x 5 2 MHz transducer to the system Performance 2 select Gen for optimization and OB for exam type Tests 3 Couplethe transducer to the phantom adjusting gain settings and transducer for a proper phantom image e g pins are high level echoes positioned in straight lines cysts are sonolucent edges are sharp and graphite particles of the phantom are mid grays Chapter 7 Performance Testing 45 Basic Operational Tests Basic System 1 Operation Tests Verify that the correct transducer name appears in the upper right corner of the system display Verify proper date and time Verify that the scan plane orientation mark in the image located near the skinline corresponds to element 1 on the transducer To test put your finger on the probe and run it across the transducer face Your finger touching the transducer face should appear at the orientation mark on the display image format Verify that all of the keyboard keys are functional Verify that all controls ope
43. he maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Radiated RF Field strengths from fixed RF IEC 61000 4 3 transmitters as determined by an electromagnetic Site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol continued Note Ur is the AC mains voltage prior to application of the test level At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the SonoSite ultrasound system is used exceeds the applicable RF compliance level above the SonoSite ultrasound system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the SonoSite ultrasound system
44. ical electronic implants The needle guide bracket for the P10x P17x and P21x transducers contains a magnet that is used to ensure the bracket is correctly oriented on the transducer The magnetic field in direct proximity to the pacemaker or medical electronic implant may have an adverse effect Hazardous materials WARNING WARNING Products and accessories may contain hazardous materials Ensure that products and accessories are disposed of in an environmentally responsible manner and meet federal and local regulations for disposing hazardous materials The liquid crystal display LCD contains mercury Dispose of the LCD properly in accordance with local regulations Chapter 3 Safety 13 Electromagnetic compatibility The ultrasound system has been tested and found to comply with the electromagnetic compatibility EMC limits for medical devices to IEC 6060 1 1 2 2001 These limits are designed to provide reasonable protection against harmful interference in a typical medical installation WARNING Caution Caution The Edge ultrasound system should not be used adjacent to or stacked with other equipment If such use occurs verify that the Edge ultrasound system operates normally in that configuration Medical electrical equipment requires special precautions regarding EMC and must be installed and operated according to these instructions Portable and mobile RF communications equipment can affect the ultrasound s
45. id electrical shock before cleaning disconnect the system from the power supply or remove from the mini dock or docking system To avoid infection always use protective eyewear and gloves when performing cleaning and disinfecting procedures To avoid infection ensure that the solution expiration date has not passed Do not spray cleaners or disinfectant directly on the system surfaces Doing so may cause solution to leak into the system damaging the system and voiding the warranty Do not use strong solvents such as thinner or benzene or abrasive cleansers since these will damage the exterior surfaces Use only recommended cleaners or disinfectants on system surfaces Immersion type disinfectants are not approved for use on system surfaces When you clean the system ensure that the solution does not get inside the system controls or the battery compartment Do not scratch the LCD screen To clean the LCD screen Dampen a clean non abrasive cotton cloth with an ethanolic based cleaner and wipe the screen clean Apply the cleaner to the cloth rather than the surface of the screen To clean and disinfect system surfaces 1 Turn off the system 2 Disconnect the system from the power supply or remove it from the mini dock or docking system 3 Clean the exterior surfaces using a soft cloth lightly dampened in a mild soap or detergent cleaning solution to remove any particulate matter or body fluids Apply the solution to th
46. ignal is represented as different gray scale values CW Doppler mode provides the clinician with the ability to obtain blood flow velocities focused about a user specified focal region A continuous transmit waveform of ultrasound energy with a known frequency is transmitted and focused by the system on the receive side the transducer receive echoes are continuously amplified focused about the focal region and converted to a base band quadrature signal The signal is analyzed by a quadrature phase detector that establishes two receive channels to allow detection of flow direction These two channels are then analyzed by a fast complex Fourier transform FFT circuit to establish the spectrum of frequencies present in the echoes The data are displayed as spectrum frequencies with respect to time CW can be used alone but is normally used in conjunction with a 2D image for spatial reference The 2D image has a graphical line D line superimposed on the 2D image indicating where the M mode beam is located 24 Chapter 4 System Overview SonoSite Pulsed Wave PW provides a real time representation of blood flow and is displayed as a PW Doppler velocity versus time sweeping output Velocity or frequency is presented as the vertical axis with time along the horizontal axis The magnitude of the detected signal is represented as different gray scale values The ultrasound data is derived from a single area the sample volume on a stationary beam
47. inspect the transducer face housing and cable Do not use the transducer if the transducer or cable is damaged Always disconnect the power supply from the system before cleaning the system Do not use any transducer that has been immersed beyond the specified cleaning or disinfection level See Chapter 6 Maintenance Use only accessories and peripherals recommended by SonoSite including the power supply Connection of accessories and peripherals not recommended by SonoSite could result in electrical shock Contact SonoSite or your local representative for a list of accessories and peripherals available from or recommended by SonoSite Chapter 3 Safety 9 WARNING To avoid the risk of electrical shock and fire hazard Inspect the power supply AC power cords cables and plugs on a regular basis Ensure that they are not damaged The power cord set that connects the power supply of the ultrasound system or the stand to mains power must only be used with the power supply or docking system and cannot be used to connect other devices to mains power WARNING To prevent injury to the operator bystander the transducer must be removed from patient contact before the application of a high voltage defibrillation pulse WARNING To avoid possible electrical shock or electromagnetic interference verify proper operation and compliance with relevant safety standards for all equipment before clinical use Connecting additional equi
48. ities The system includes the optional ability to measure the intima media thickness IMT of the carotid artery using digital ultrasound images The IMT measurement of the carotid artery may be used adjunctively with other medical data obtained by a physician to help assess the cardiovascular health of a patient The system includes optional Digital Imaging and Communications DICOM capabilities as well as general computer communication capabilities to provide the acceptance transfer display storage and digital processing of ultrasound images and loops Security support is also provided to facilitate HIPAA compliance The system transducer is capable of exceeding a Tl or an MI of 1 0 in certain operating modes or mode combinations The system displays the current output level in terms of one of two bioeffects indices Mechanical Index MI and Thermal Index TI in accordance with the AIUM NEMA Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Chapter 4 System Overview 21 Theory of Operation 22 The Edge ultrasound system has seven 7 major functional groups e Transducer e Acquisition Subsystem e Processing Subsystem e Display Subsystem e Control Subsystem e User Interface Subsystem Power Subsystem is a system block diagram that shows the relationship of the functional groups we External video to monitor
49. l Group The power subsystem includes the battery pack and battery charging electronics Description of Operating Modes 2D Mode 2D mode is a two dimensional image of the amplitude of the echo signal It is used for location and measurement of anatomical structures and for spatial orientation during operation of other modes In 2D a two dimensional cross section of a 3 dimensional soft tissue structure such as the heart is displayed in real time Ultrasound echoes of different intensities are mapped to different gray scale or color values in the display The outline of the 2D cross section may be a rectangle parallelogram trapezoid sector or a full circle depending on the particular transducer used 2D mode can be used in combination with any other modes M Mode M Mode is also known as T M mode or time motion mode It is used primarily for cardiac measurements such as valve timing and septal wall thickness when accurate timing information is required Ultrasound echoes of different intensities are mapped to different gray scale values in a scrolling display M Mode displays time motion information of the ultrasound data derived from a stationary beam Depth is arranged along the vertical axis with time along the horizontal axis M Mode can be used alone but is normally used in conjunction with a 2D image for spatial reference The 2D image has a graphical line M line superimposed on the 2D image indicating where the M Mode beam is located
50. ment is an integral part of the quality assurance program Penetration is defined as the deepest depth at which an ultrasound system can provide adequate image quality of small anatomical structures Penetration measurements should be performed and the results retained for comparison to future measurements Penetration measurements should remain fairly consistent over time assuming use of the same system settings and scanhead Degradation of the penetration measurement in excess of 1cm may indicate a transducer or system electronics issue Loss of measured penetration may also be caused by degradation dessication of the ultrasound phantom Ultrasound phantoms used for penetration measurements must also be part of a quality assurance program to maintain their integrity Follow all of the phantom manufacturer recommendations for use storage and maintenance of the phantom Test Penetration Use the same scanhead and system settings as previous measurements if possible Adjust the system controls to obtain a clear image that shows the limits of echo penetration Press the Freeze key and then save the image Measure from the center of the skinline to the deepest vertical position where the scatter echoes start to break up and tissue definition is lost 5 Record and retain the results for future reference Scanhead type and system settings exam type depth resolution mode etc should also be recorded to ensure proper comparison with future
51. mpliance to the requirements of IEC60601 1 2 2007 You may use these SonoSite accessories and third party peripherals with the Edge ultrasound system WARNING WARNING Accessories and peripherals compatible with Edge ultrasound system Description C8 transducer C11x transducer C60x transducer D2x transducer HFL 38x transducer HFL50x transducer ICTx transducer L25x transducer L38xi transducer L52x transducer Vet P10x transducer P21x Transducer SLAx transducer TEEx Transducer Bar code scanner Battery for PowerPack Battery Pack PowerPack Black amp white printer 6 Chapter 2 Specifications Part Number P08010 P07678 P07680 P05165 PO7682 PO7693 P07690 P07691 P12742 V00033 P07696 P07698 P07699 P05183 P14166 P13123 P15051 P13122 P13745 Use of accessories other than those specified may result in increased emissions or decreased immunity of the ultrasound system Maximum Cable Length 6 0 ft 1 8 m 6 5 ft 2 0 m 6 0 ft 1 8 m 6 0 ft 1 8 m 6 0 ft 1 8 m 6 0 ft 1 8 m 6 0 ft 1 8 m 8 0 ft 2 4 m 6 0 ft 1 8 m 7 9 ft 2 4 m 6 5 ft 2 0 m 6 5 ft 2 0 m 8 0 ft 2 4 m 7 5 ft 2 3 m 4 8 ft 1 5 m Use of the accessories with medical systems other than the Edge ultrasound system may result in increased emissions or decreased immunity of the medical system Bi SonoSite Accessories and peripherals compatible with Edge ultrasound system Continued Black amp white printer power 3 3 ft
52. n circuitry A one wire bidirectional serial interface BDATA will be used to read and write the pack data Battery Charger The charge circuitry is in the external AC DC Adapter as shown in the following block diagram POWER SUPPLY BATTERY CHARGER Output Cable Voltage Source ommon Mode Choke Line 3 turns on Fair Rite Neutral PN 263162510 Ground 2 RATE SYNC Control S20K Voltage SSES kt VSENSE Geer PWR RETURN Cable Shield Figure 4 8 Battery Charging Subsystem Block Diagram Chapter 4 System Overview 33 ECG Module The ECG module allows a representation of the heart electrical activity to be displayed in real time with ultrasound images acquired and displayed on the system video display The ECG module interfaces to the patient through three 3 ECG leads Right Arm ECG lead RA Left Arm ECG lead LA and Left Leg ECG lead LL The ECG received signal from the ECG electrodes are isolated amplified and filtered by the ECG module before it is sent to the system for further processing and display The ECG module and cable are an integrated assembly The module receives power from the system Patient isolation is provided by the ECG module allowing the connection and signals to the system to be system ground referenced The isolation between the patient and the system meets the requirements of IEC 601 1 for Type CF equipment The ECG function accepts input from an external serial A D and p
53. nce Industrial Scientific and Medical ISM Equipment Radio Frequency Disturbance Characteristics Limits and Methods of Measurement Classification for the ultrasound system docking system accessories and peripherals when configured together Group 1 Class A IEC 60601 1 2 2007 Medical Electrical Equipment Part 1 2 General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests Acoustic standards NEMA UD 2 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment NEMA UD 3 2004 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment American Institute of Ultrasound in Medicine Chapter 3 Safety 19 20 Biocompatibility standards AAMI ANSI ISO 10993 1 Biological evaluation of medical devices Part 1 Evaluation and testing 2009 AAMI ANSI ISO 10993 5 Biological evaluation of medical devices Part 5 Tests for In Vitro cytotoxicity 2009 AAMI ANSI ISO 10993 10 Biological evaluation of medical devices Part 10 Tests for irritation and delayed type hypersensitivity 2002 AAMI ANSI ISO 10993 1 1 Biological evaluation of medical devices Part 11 Tests for systemic toxicity 2006 AAMI ANSI ISO 10993 12 Biological evaluation of medical devices Part 12 Sample preparation and reference materials 2007 Airborne equipment standards RTCA DO 160E Radio Technical Commis
54. of a successful service event Review all saved images and verify that the images are displayed properly 50 Chapter 7 Performance Testing Sonosite Printer The printer test is an optional test that requires a video printer and minidock to be connected to the system under test Skip this test if a printer and minidock are not available Test Printer Operation Battery Charging Test Battery Charging Operation Video Output Connect the minidock to the system under test Connect the video output of the minidock to the printer Verify proper printer type is configured in the system Setups page Press the print button and verify that the printer begins to print an image After the image begins to emerge from the printer press the print button again The printer should ignore the second print command Verify the proper content of the printed image Remove the system from the docking system and insert a battery into the system Press the Power key to turn the system on Allow the battery to discharge The battery indicator icon on the display below the Transducer Type indicator will extinguish from left to right as the battery discharges Note The Power and Sleep delays in the Setup page should be selected to Off to properly perform this test The battery may take 1 2 hours to discharge Reattach the system to the Docking System and attach the AC power cord to the power connector Note that the battery indicator indicate
55. ow disinfectant to contact metal surfaces Use a soft cloth lightly dampened in a mild soap or compatible cleaning solution to remove any disinfectant that remains on metal surfaces Caution Attempting to disinfect a transducer or transducer cable using a method other than the one included here can damage the transducer and void the warranty To clean and disinfect a transducer wipe method 1 2 3 Disconnect the transducer from the system Remove any transducer sheath Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning solution to remove any particulate matter or body fluids Apply the solution to the cloth rather than the surface Rinse with water or wipe with water dampened cloth then wipe with a dry cloth Mix the disinfectant solution compatible with the transducer following disinfectant label instructions for solution strengths and disinfectant contact duration Wipe surfaces with the disinfectant solution Air dry Examine the transducer and cable for damage such as cracks splitting or fluid leaks If damage is evident discontinue use of the transducer and contact SonoSite or your local representative Chapter 6 Maintenance 41 42 To clean and disinfect a transducer immersion method 1 Disconnect the transducer from the system 2 Remove any transducer sheath 3 Clean the surface using a soft cloth lightly dampened in a mild soap or compatible cleaning solution to r
56. ower Supply Shield Appendix A Replacement Parts 55 Miscellaneous Parts Table A 4 Miscellaneous Parts Part Number Description Cables images are not to scale PO2308 FFC 12 Position Jumper 0 5 Pitch 3 Length 37 Flat Flex Cable This cable is used in two locations on the Control Panel PCB P14729 Cable Assy Main to Control Panel PCB Video P14747 Cable Main To Control Panel PCB Backlight P15410 FFC 12 Position 0 5MM Pitch Opposite Side 8 Flat Flex Cable 56 Appendix A Replacement Parts SonoSite Table A 4 Miscellaneous Parts Part Number Description Other Electrical Parts PO2312 Fan Assembly P03872 Speaker Assembly P14727 USB Extension PCB Assy P14742 Compression Connector Insulator EDGE Used with P15723 P15273 Connector Compression 166 Wires Inch 33 350 Used with P14742 Appendix A Replacement Parts 57 Table A 4 Miscellaneous Parts Part Number Description Mechanical Cosmetic Parts Bottom Enclosure Contact SonoSite Technical Support if it is necessary to replace the bottom enclosure Ordering the bottom enclosure requires special handling due to the serial number label P09542 Power Supply Shield 58 Appendix A Replacement Parts SonoSite Table A 4 Miscellaneous Parts Part Number Description P14750 Foot 4x P15305 Hinge Cover P16156 Service Assembly EDGE Top Enclosure Appendix A Replacement Parts 59 Tran
57. pment to the ultrasound system constitutes configuring a medical system SonoSite recommends verifying that the system all combinations of equipment and accessories connected to the ultrasound system comply with JACHO installation requirements and or safety standards such as AAMI ES 1 NFPA 99 OR IEC Standard 60601 1 1 and electromagnetic compatibility standard IEC 6060 1 1 2 Electromagnetic compatibility and are certified according to IEC Standard 60950 Information Technology Equipment ITE Caution Do not use the system if an error message appears on the image display note the error code call SonoSite or your local representative turn off the system by pressing and holding the power key until the system powers down Caution To avoid increasing the system and transducer connector temperature do not block the airflow to the ventilation holes on the side of the system 10 Chapter 3 Safety SonoSite Electrical safety classification Class eduipment Internally powered equipment Type BF applied parts Type CF applied parts IPX 7 watertight equipment IPX 8 watertight equipment Non AP APG Equipment safety The ultrasound system is classified as Class equipment when powered from the external power supply or mounted on the stand because the external power supply is a Class 1 protectively earthed power supply The stand has no protective earth Ground bond testing is not applicable to the ultrasound sys
58. rate smoothly over their full range and that the system responds properly Verify that as the Gain controls are increased and decreased there is a corresponding increase and decrease in echo intensity Capture a Cineloop buffer Exercise the Cineloop controls and verify proper operation Close the lid and verify the unit goes into sleep mode Open the lid and verify the unit returns to normal operation Verify the airflow from the vent on the left side of the system is blowing out 2D Performance Tests 2D Performance Image Quality 46 Test 2D 1 Performance 2 and Image 3 Quality 4 5 6 7 Use a C60x 5 2 MHz transducer in 2D mode Adjust the position of the C60x 5 2 MHz transducer on the phantom With the array pointing down and the orientation mark to the operator s left element 1 corresponds with the left side of the array Use the 2D system controls to obtain a clear image that shows both the horizontal and vertical rows of pins Verify that the ultrasound image appears uniform in both the axial and lateral direction with no dropouts or intensity variations Verify that the cystic structure at the focal zone is clearly differentiated from the surrounding tissue and is echo free while solid tissue with numerous echo sources appears solid Press the Freeze key and then save the image Press the Freeze key again to return to live imaging Chapter 7 Performance Testing SonoSite Axial Measurement Accuracy Note Me
59. re use Some transducer sheaths contain natural rubber latex and talc which can cause allergic reactions in some individuals Refer to 21 CFR 801 437 User labeling for devices that contain natural rubber Perform ultrasound procedures prudently Use the ALARA as low as reasonably achievable principle and follow the prudent use information concerning MI and TI SonoSite does not currently recommend a specific brand of acoustic standoff If an acoustic standoff is used it must have a minimum attentuation of 3dB cm MHz Some SonoSite transducers are approved for intraoperative applications if a market cleared sheath is used To avoid injury or reduce the risk of infection to the patient observe the following Follow Universal Precautions when inserting and maintaining a medical device for interventional and intraoperative procedures Appropriate training in interventional and intraoperative procedures as dictated by current relevant medical practices as well as in proper operation of the ultrasound system and transducer is required During vascular access the potential exists for serious complications including without limitation the following pneumothorax arterial puncture guidewire misplacement and risks normally associated with local or general anesthesia surgery and post operative recovery To avoid device damage or patient injury do not use the P10x P17x or P21x needle guide bracket on patients with pacemakers or med
60. s AU727381 AU730822 CA2372152 CA2372158 CA2373065 CN ZL 97113678 5 CN ZL 98106133 8 CN ZL 98108973 9 CN ZL 200830007734 8 DE60021552 0 DE60029777 2 DE60034670 6 DE69730563 5 DE6980539 6 DE69831698 3 DE60 2004 23 816 3 08 FR0815793 FR0875203 FR088 1492 FR1175713 FR 1180970 FR1589878 GB0875203 GB0881492 GB1175713 GB1180970 GB1180971 GB1589878 IT0815793 ITO88 1492 IT1175713 IT1589878 KR528102 KR532359 NO326202 NO3268 14 NZ542968 RCD000897368 0001 SP0815793 SP088 1492 SP 1589878 Patents pending P15644 01 12 2011 Copyright 2011 by SonoSite Inc All rights reserved Bi SonoSite Table of Contents Introduction el le sas TE EE EE 1 Contact InISr at OR coser E EE AE EE De cence ate ene 1 Conventions symbols and terms 1 Eee UN SUDHIDOIS ass o DE OE Ee GE vidit dieti ge pad 2 Specifications olie jle len ORR ETT ETE RE TIT 5 DIMENSION TE N EE wee i ae wee ee EE NE N IE 5 Environmental ES EE 5 Se Eeer Tee EE 5 Battery SDeCIICAWONS aires oie HEES RD N EG RIS RS 6 Compatible accessories and peripherals cesses 6 Safety lei slet ee ROES ELS EO SR DE ERSTE SEC E ie E 9 Electrical safety classification sesse ccc ccc ccc ene nee GE Ee ee ee GE ER ee ee ee 11 EIDE Sal eb usc esr vett d ED UPPER Mole VERAS FII ER EG MO S BUE E 11 Ee 12 le e E ee soe RE EE EE tame ae e o SG aes OE RE EE AE CS SE 13 Hazardous materials ss ss ss ss ss EE EE eee EE se Ee EE se EE EE EE EE EE E
61. s for correctness e g film size format Chapter 5 Troubleshooting 37 38 Chapter 5 Troubleshooting SonoSite Chapter 6 Maintenance This chapter contains information to help you properly care for the system transducers and accessories Periodic Maintenance No periodic or preventive maintenance is required for the system transducers or accessories other than cleaning and disinfecting the transducer after every use See Cleaning and disinfecting transducers on page 41 There are no internal adjustments or alignments required and there are no internal components that require periodic testing calibration adjustment or alignment Performance tests are described in Chapter 7 Performance Testing ofthis manual Performing maintenance procedures not described in this manual may void the product warranty Local regulations may require electrical safety testing Contact SonoSite Technical Support for any maintenance questions See Technical Support USA Canada on page 1 Cleaning and disinfecting Use the recommendations in this section when cleaning or disinfecting the ultrasound system transducer and accessories Use the cleaning recommendations in the peripheral manufacturer s instructions when cleaning or disinfecting peripherals For recommended cleaners and disinfectants see the disinfectant list available on the CD included with the ultrasound system and on www sonosite com WARNING Disinfectants and cle
62. s that the battery is charging The sections of the battery indicator will light sequentially from left to right as the battery charges The video output test is an optional test that requires a minidock and external video monitor to be connected to the system under test Skip this test if a minidock and external monitor are not available Test Video Output Connect the minidock to the system under test Connect the video output of the minidock to an external video monitor Turn on the system power and verify that the video on the external monitor matches the video on the system display If the video does not appear similar or there is no display on the external monitor see Chapter 5 Troubleshooting for troubleshooting procedures Chapter 7 Performance Testing 5 52 Chapter 7 Performance Testing Sonosite Appendix A Replacement Parts The following tables contain all the field replaceable parts for the EDGE ultrasound system Quantities are one unless otherwise noted Display Sonosite Table A 1 Display Part Number P15637 P15638 V15637 V15638 Description Service Assembly Display Edge Warranty Service Assembly Display Edge Vet Service Assembly Display Edge Vet Warranty Service Assembly Display Edge Appendix A Replacement Parts 53 Control Panel Table A 2 Control Panel Part Number Description P15630 Warranty Service Assembly Control Panel English Edge P15631 Warranty Service
63. sducer Nest Frame Assembly m1 2 6 5 3 4 Figure A 1 Nest Frame Parts Table A 5 Nest Frame Assembly Find Number Part Number Description 1 P07750 Nest Frame Assembly 2 POO364 Connector Interposer 8x 3 P03833 Shield Perimeter Short 2x 4 P03834 Shield Perimeter Long 2x 5 POO924 Screw Shoulder Thrust Plate 4x 6 P00353 Wear Plate not shown P00646 Spring Thrust Plate 047 wire 4x 7 PO8200 Socket Head Cap Screw M2 5 45x10mm 4x Ordering Replacement Parts To order parts contact SonoSite Technical Support as indicated in Contact Information on page 1 60 Appendix A Replacement Parts SonoSite Appendix B Service Event Reporting The Service Event Report provides information about product failures to the manufacturer and to authorized service facilities which provide approved warranty services for SonoSite products For all repairs completed complete the form and email a copy of it to service sonosite com or mail to the following address SonoSite Inc Technical Support 21919 30th Drive SE Bothell Washington 98021 USA To contact SonoSite Technical Support see Contact Information on page 1 Appendix B Service Event Reporting 61 Service Event Report Form gt Sono rasound into Choose a Service Type service Event Report Choose a Part Status Instructions on reverse Service Type check one Parts Status check one For SonoSite Use C No parts nece
64. sion for Aeronautics Environmental Conditions and Test Procedures for Airborne Equipment Section 21 0 Emission of Radio Frequency Energy Category B 118 DICOM standard NEMA PS 3 15 Digital Imaging and Communications in Medicine DICOM Part 15 Security and System Management Profiles HIPAA standard Health Insurance and Portability and Accountability Act Pub L No 104 191 45 CFR 160 General Administrative Requirements 45 CFR 164 Security and Privacy Chapter 3 Safety SonoSite Chapter 4 System Overview About the System The SonoSite Edge high resolution ultrasound system is a portable full featured general purpose software controlled diagnostic ultrasound system using all digital architecture The system is used to acquire and display high resolution real time ultrasound data in 2D M Mode Pulsed Wave PW Doppler Continuous Wave CW Doppler Color Power Doppler CPD and color Doppler Color or in a combination of these modes The system has an electrocardiography ECG display feature and supports a 3 lead ECG cable assembly to collect data for M Mode and Doppler measurements The system provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes The system has a PW and CW Doppler audio output feature cine review image zoom labeling biopsy measurements and calculations image storage and review printing and recording capabil
65. ssary for this repair Service O Out of Box Failure Ll Event Repor for your information Service Request need parts for this repair list the parts below O Warranty Service EL ndi suse Order Order Number need parts to replenish my stock list the RMA Number L1 Out of Warranty Service O parts used below and attach Purchase Order RMA Number Will not replenish stock Please give me a O RMA for the return of the faulty parts Work Order Enter complete e No parts necessary Please issue a RMA for contact information O repair at SonoSite Service Provider Name Provider Reference Date Reported Enter product information for the system being repaired Device Description Ref Number ARM SHDB Version Problem Found Service Performed Performed By Parts Removed Enter DETAILED problem description here Serial Number Lot Number Configuration Put the system configuration here You can find this on the System Information Page Part Name Part Number Serial Number Lot Number Replace Enter details for parts being removed from the system Parts Installed Part Name Tests Performed attach test data Enter details for parts being installed into the system Replace 62 Appendix B Service Event Reporting Service Event Report Instructions Instructions for completing the Service Event Report Sections highlighted in yellow mus
66. t be completed for SonoSite to accept the Service Event Report If additional information is required for certain circumstances you will be advised Forward the completed form to Email service sonosite com Fax 1 425 951 6700 Service Type e Out of Box Failure the item has arrived from SonoSite with failures e Warranty Service the item has failed after arrival and is covered by either the included warranty or a valid extended warranty e Out of Warranty Service the item has failed and it is no longer covered by a warranty Parts Status e Check One Service Provider e Name the name of the technician performing the work e Provider Reference a unique number used by the Provider to track Service Event Reports Any format is acceptable e Company the name of the Distributor or authorized repair facility e Address the address replacement parts will be shipped to e Date Reported the date the failure was reported to SonoSite e Phone Number the phone number to contact the service technician e Fax Number the fax number to contact the service technician e Email Address the email address to contact the service technician Device Description e Name the description of the failed product Ref Number the reference number from the part number label of the failed product Serial Number the serial number from the part number label of the failed product Lot Number if applicable the Lot Number from the device identification label ARM
67. tem or the stand Note AC powered peripherals that may be used with the system are Class land are individually protectively earthed Ground bond testing may be conducted on each AC powered peripheral Ultrasound system not connected to the power supply battery only Ultrasound transducers ECG module ECG leads Ultrasound transducers Footswitch Ultrasound system power supply docking system and peripherals Equipment is not suitable for use in the presence of flammable anaesthetics To protect your ultrasound system transducers and accessories follow these precautions Caution Excessive bending or twisting of cables can cause a failure or intermittent operation Caution Improper cleaning or disinfecting of any part of the system can cause permanent damage For cleaning and disinfecting instructions see Chapter 6 Maintenance Caution Do not submerge the transducer connector in solution The cable is not liquid tight beyond the transducer connector cable interface Caution Do not use solvents such as thinner or benzene or abrasive cleaners on any part of the system Caution Remove the battery from the system if the system is not likely to be used for some time Caution Do not spill liquid on the system Chapter 3 Safety 11 Battery safety To prevent the battery from bursting igniting or emitting fumes and causing personal injury or equipment damage observe the following precautions
68. tests DS U N 6 Press the Freeze key again to return to live imaging Additional Performance Tests Color Doppler Color 48 Test Color Connect any transducer 2 Press the Color key Color should be annotated in the top left corner of the display 3 A Region of Interest ROI box is displayed on top of the grayscale image Use the touchpad to move the Color ROI Verify that the ROI moves to the new position on the display Adjust the Depth control for minimum depth in the image Adjust the Gain control so that color speckles just appear inside the ROI box 6 Gently tap the face of the transducer and observe that the ROI box fills with color information U A 7 Press the Freeze key and then save the image Press the Freeze key again to return to live imaging Chapter 7 Performance Testing SonoSite Color Power Doppler CPD Test CPD 1 Connect any transducer 2 Press the Color key A Region of Interest ROI box is displayed on top of the grayscale image 3 Press the Color softkey to switch to CPD CPD should be annotated in the top left corner of the display Adjust the Depth control for minimum depth in the image Adjust the Gain control so that color speckles just appear inside the ROI box 6 Gently tap the face of the transducer and observe that the ROI box fills with color information U A M Mode Imaging Test M Mode Attach a C60x transducer and acquire an image Imaging Press the M Mode ke
69. the sound from the speakers 6 Pressthe Freeze key and then save the image Press the Freeze key again to return to live imaging 7 Press the 2D key to return to 2D imaging U bh U N Continuous Wave CW Doppler Imaging Test CW 1 Attach the P21x transducer Doppler 2 Press the Patient key Imaging 3 Selectthe Cardiac exam type 4 Pressthe Done softkey 5 Press the Doppler key for the Doppler sample gate 6 Press the PW softkey to switch to CW Mode 7 Press the Doppler key again for the Doppler spectral trace 8 Place a large drop of ultrasound gel on the transducer lens 9 Adjust the Gain control as necessary and then gently tap the top of the gel and observe a reflection on the spectral trace and the sound from the speakers 10 Press the Freeze key and then save the image Press the Freeze key again to return to live imaging 11 Press the 2D key to return to 2D imaging Image Quality Verification Test Livescan Products with replaced subassemblies or products that have been otherwise disassembled must undergo an Image Quality Verification Test Livescan e The Image Quality Verification Test Livescan should be performed after successfully completing all applicable performance tests listed prior in this chapter The test is completed before returning the system to service A certified sonographer must perform the test e The Livescan test performed is at the discretion of the Sonographer and will represent their acceptance
70. tion Definition Serial number type of control number Temperature limitation Atmospheric pressure limitation Humidity limitation Submersible Protected against the effects of temporary immersion Water Tight Equipment Protected against the effects of extended immersion Handle transducer with care Follow manufacturer s instructions for disinfecting time Disinfect transducer Type BF patient applied part B body F floating applied part Defibrillator proof type CF patient applied part Underwriter s Laboratories labeling Pollution Control Logo Applies to all parts products listed in the China RoHS disclosure table May not appear on the exterior of some parts products because of space limitations China Compulsory Certificate mark CCC Mark A compulsory safety mark for compliance to Chinese national standards for many products sold in the People s Republic of China WARNING Connect Only Accessories and Peripherals Recommended by SonoSite Zi SonoSite Chapter 2 Specifications This chapter contains information regarding system specifications and accessory compatibility The information applies to the ultrasound system transducers accessories and peripherals Specifications Dimensions System e Length 13 in 33 cm e Width 12 4 in 31 5 cm e Height 2 5 in 6 3 cm Display e Length 9 7 in 24 6 cm Height 7 3 in 18 5 cm Diagonal 12 1 in 30 7 cm
71. ulse is used to support good axial resolution For Doppler modes a narrower band pulse is used which improves the spectral resolution of the detected Doppler signal In addition to transmit pulse control programmable digital signal processing is used in the receive path to further refine the bandwidth used to produce the final image Digital filters are applied to the digitized received signal to limit and shape the spectral bandwidth used to generate the displayed output In this feature parameters for signal and image processing are optimized to maximize the image quality or to obtain the best compromise of resolution and penetration for different specific clinical applications These parameters include the order of received filters the bandwidth the dynamic range the compression curve the gain setting and parameters for compounding frequency band etc For example different system parameter setups are used for abdominal or peritoneal scanning This feature is for ease of use for the operator by automatically setting up system control parameters rather than manually adjusting settings for best performance The system can display a pair of biopsy guidelines that represent the anticipated path of the biopsy needle The image of an anatomical target biopsy guidelines a scan plane marker and a biopsy needle are displayed to assist in guiding the biopsy needle to the target The system also provides needle guidance for vascular access proce
72. ure 5 1 shows an assert screen The assert information required is the information listed on the C line and the D line N EE Data access abort exception Oxdf 223 0x0 0 0x1 R 8 0x7e9a64 Ox7eb570 Ox7eb2dc 0x4 R11 0x0 R12 Oxceb1d8 0x0 R13 Oxfc776c 0x0 R14 Oxfffffff8 0x0 R15 Oxfffffff8 Oxfe77d4 Figure 5 1 Assert Screen Verifying a System Assert Code Record all information on the C line and D line and contact Technical Support System asserts are caused by hardware and or software faults Hardware asserts typically require main PCBA replacement Software asserts can be reset and the system may recover A simple method to identify the cause of the assert is identified here Assert Cause 1 Record the assert code 2 Press and release the Power button to power the system down 3 Pressthe Power button again to power on the system If the system powers on normally it has recovered from the fault software assert and you may use the system If the assert condition remains corrective action must be taken usually replacement of the main PCBA is required Contact SonoSite Technical Support for assistance and to obtain repair parts If the Power button is not functional all sources of power must be removed to allow the system to power down l e disconnect AC power and remove the battery 36 Chapter 5 Troubleshooting Bi SonoSite DICOM Table 5 2 DICOM Troubleshooting Error
73. void the risk of electrical shock or injury do not open the system enclosures All internal adjustments and replacements except battery replacement must be made by a qualified technician WARNING To avoid the risk of electrical shock This equipment must be connected only to a supply mains with protective earth Use only properly grounded equipment Shock hazards exist if the power supply is not properly grounded Grounding reliability can be achieved only when equipment is connected to a receptacle marked Hospital Only or Hospital Grade or equivalent The grounding wire must not be removed or defeated When using the system in an environment where the integrity of the protective earth conductor arrangement is in doubt operate the system on battery power only and disconnect the power supply Do not let the bar code scanner or external mouse touch the patient Do not touch any of the following The power supply and the patient at the same time The ungrounded signal input output connectors on the back of the ultrasound system The system battery contacts inside the battery compartment he system transducer connector when the transducer or Triple Transducer Connect TTC is disconnected The system transducer connector on the TTC if no transducers are connected Do not connect the system power supply or docking system to a multiple portable socket outlet MPSO or extension cord Before using the transducer
74. witch to protect the receiver from the transmit voltage a vari able gain receiver to amplify and condition the return echoes an A D to digitize the data a delay block to focus the return signals and a weight block to scale the return echoes for each channel All the signals are then summed together to generate the beam formed receive data The analog gain varies with depth to compensate for signal attenuation through the medium The delays and weights are independent for each channel The delay and weight for the receive channel can typically be changed dynamically to keep the receive beam in continuous focus The delay is simply set by the time of flight in the medium from the point of interest to the element which starts at skin line and proceeds to the deepest depth of interest The control section drives the data to the various data path elements on a line by line basis controls the timing of the transmit and receive sections and controls the tagged information and timing of the data to the rest of the system Chapter 4 System Overview 27 PW Doppler Processing Doppler processing includes both audio processing which presents Doppler signal in the form of stereo audio and spectral processing which generates data for display of Doppler spectrum in the form of a scrolling spectrogram Doppler power spectrum is estimated performing Discrete Fourier Transforms on short overlapped segments of wall filtered Doppler signal Doppler audio data is gen
75. y for the M Mode sample line Press the M Mode key again to turn on M Mode Select the desired sweep speed from the on screen menu slow med or fast The on screen menu will show the selected sweep speed 6 Press the Freeze key to freeze the image Save the image Press the Freeze key again to return to live imaging 1 2 3 Position the M Mode sample line over the image using the touchpad 4 5 7 Pressthe 2D key to return to 2D imaging Tissue Harmonic Imaging Test THI 1 Attach the C60x transducer and acquire an image Imaging 2 Setthe depth to maximum and note the depth at which echo information is lost 3 Pressthe THI key on the control panel so it displays THI on the display Tissue Harmonic Imaging in now active 4 Observe a decrease in dot size and a significant loss in penetration due to the higher frequency Image resolution increases 5 Press the Freeze key and then save the image Press the Freeze key again to return to live imaging 6 Press the THI key again to turn off Tissue Harmonic Imaging Chapter 7 Performance Testing 49 Pulsed Wave PW Doppler Imaging Test PW Attach the P21x transducer Doppler Press the Doppler key for the Doppler sample gate Imaging Press the Doppler key again for the Doppler spectral trace Place a large drop of ultrasound gel on the transducer lens Adjust the Gain control as necessary and then gently tap the top of the gel and observe a reflection on the spectral trace and
76. yl alcohol Is recommended 4 Air dry Cleaning the footswitch Caution To avoid damaging the footswitch do not sterilize It is not intended for use in a sterile environment To clean the footswitch 1 Dampen a non abrasive cloth with one of the following products e sopropyl alcohol e Soap and water e Cidex e Sodium Hypochlorite 5 25 Bleach diluted 10 1 2 Wring out cloth until slightly wet and then gently rub soiled area until clean Chapter 6 Maintenance SonoSite Cleaning and disinfecting ECG cables Caution To avoid damaging the ECG cable do not sterilize To clean and disinfect the ECG cable wipe method 1 Remove the cable from the system 2 Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning solution Apply the solution to the cloth rather than the surface 3 Wipe the surfaces with any of the following products e Bleach sodium hypochlorite e Cidex disinfectants Green soap 4 Air dry or towel dry with a clean cloth Chapter 6 Maintenance 43 A4 Chapter 6 Maintenance SonoSite Chapter 7 Performance Testing Overview WARNING Critical Test Function A failure of the system functions tested in this section could affect safety or effectiveness of the system adversely While performing the steps in this section verify that the images on the system display and on the external monitor are acceptable To obtain 2D images SonoSite recommends using t
77. ystem Electromagnetic interference EMI from other equipment or interference sources could result in performance disruption of the ultrasound system Evidence of disruption may include image degradation or distortion erratic readings equipment ceasing to operate or other incorrect functioning If this occurs survey the site to determine the source of disruption and take the following actions to eliminate the source s e Turn equipment in the vicinity off and on to isolate disruptive equipment e Relocate or re orient interfering equipment e Increase distance between interfering equipment and your ultrasound system e Manage use of frequencies close to ultrasound system frequencies e Remove devices that are highly susceptible to EMI Lower power from internal sources within facility control such as paging systems Label devices susceptible to EMI e Educate clinical staff to recognize potential EMI related problems e Eliminate or reduce EMI with technical solutions such as shielding e Restrict use of personal communicators cell phones computers in areas with devices susceptible to EMI e Share relevant EMI information with others particularly when evaluating new equipment purchases which may generate EMI e Purchase medical devices that comply with IEC 60601 1 2 EMC Standards To avoid the risk of increased electromagnetic emissions or decreased immunity use only accessories and peripherals recommended by SonoSite

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