Service Manual i
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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 SonoSite, Inc.
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Table of Contents Introduction ...................................................................................... 1 Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Contact Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Conventions, symbols, and terms . . . . . . . . . . . . . . . . . . . . . .
Troubleshooting............................................................................... 35 System and Subsystem Diagnosis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 System Repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Test Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2D Performance Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 2D Performance / Image Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Axial Measurement Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Lateral Measurement Accuracy . . . . . . . . . . . . . . . . . . . . . . . . .
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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.
Labeling symbols The following symbols are used on the products, packaging, and containers.
Table 1: Labeling Symbols (Continued) Symbol 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 STERILE R STERILE EO Gel Sterilized using irradiation Sterilized using ethylene oxide Hot Device emits a static (DC) magnetic field.
Table 1: Labeling Symbols (Continued) Symbol Definition SN 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.
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 • Length: 13 in. (33 cm) • Width: 12.4 in. (31.5 cm) • Height: 2.5 in. (6.3 cm) Display • Length: 9.7 in. (24.6 cm) • Height: 7.3 in. (18.5 cm) • Diagonal: 12.1 in. (30.
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.
Accessories and peripherals compatible with Edge ultrasound system (Continued) Black & white printer power cable — 3.3 ft/1 m Black & white printer USB cable — 10.8 ft/3.3 m Color printer P13983 — Color printer power cable — 3.3 ft/1 m 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 Chapter 2: Specifications
Chapter 3: Safety This chapter contains electrical and clinical safety information required by regulatory agencies. The information applies to the ultrasound system, transducers, accessories, and peripherals. Electrical safety This system meets EN60601-1, Class I/internally-powered equipment requirements and Type BF and Type CF isolated patient-applied parts safety requirements.
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.
Electrical safety classification Class I equipment The ultrasound system is classified as Class I 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 system or the stand. Note: AC powered peripherals that may be used with the system are Class I and are individually protectively earthed.
Battery safety To prevent the battery from bursting, igniting, or emitting fumes and causing personal injury or equipment damage, observe the following precautions. 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.
Clinical safety WARNING: Non-medical (commercial) grade peripheral monitors have not been verified or validated by SonoSite as being suitable for diagnosis. WARNING: To avoid the risk of a burn hazard, do not use the transducer with high frequency surgical equipment. Such a hazard may occur in the event of a defect in the high frequency surgical neutral electrode connection. WARNING: Do not use the system if it exhibits erratic or inconsistent behavior.
Electromagnetic compatibility The ultrasound system has been tested and found to comply with the electromagnetic compatibility (EMC) limits for medical devices to IEC 60601-1-2:2001. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. WARNING: Caution: The Edge ultrasound system should not be used adjacent to or stacked with other equipment.
Separation distance Recommended separation distances between portable and mobile RF communications equipment 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.
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: • IEEE 802.
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.
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 IEC 60601 Test Level Compliance Level Radiated RF IEC 61000-4-3 3 Vim 80 MHz to 2.5 GHz 3 V/m Electromagnetic Environment d = 1.2 P 80 MHz to 800 MHz d = 2.
Immunity testing requirements The Edge ultrasound system complies with the essential performance requirements specified in IEC 60601-1-2 and IEC 60601-2-37.
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 10993-11, Biological evaluation of medical devices—Part 11: Tests for systemic toxicity (2006).
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.
Theory of Operation The Edge ultrasound system has seven (7) major functional groups: • • • • • • • Transducer Acquisition Subsystem Processing Subsystem Display Subsystem Control Subsystem User Interface Subsystem Power Subsystem is a system block diagram that shows the relationship of the functional groups.
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.
Color Doppler (Color) In color Doppler, a real-time, two-dimensional cross-section of blood flow is displayed. The 2D cross-section may be presented as a rectangle, parallelogram, trapezoid, sector, or a full 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.
Pulsed Wave (PW) Doppler PW provides a real-time representation of blood flow and is displayed as a 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.
Continuous Wave Doppler Audio Output The system provides for audio output of the CW velocity information. This can be 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. Pulsed Wave Doppler Audio Output The system provides for audio output of the PW velocity information.
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.
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 generated from wall filtered data by phase shifting the in-phase component.
CW Doppler Processing 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 QBP function. In place of QBP will be a low pass decimating filter that operates on incoming I/Q data.
Back End Overview 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.
Control Subsystem The Edge Control Subsystem is shown in the figure below. INFRASTRUCTURE SYSPWR, SYSCLKS, SYSRST MASS STORAGE EXPANSION FAST ETHERNET ETHERNET SYSTEM FLASH SYSTEM RAM PCI BUS 2 DUAL UART, USB PCI BRIDGE U/I, DEBUG USB DATA ADDRESS CONTROL SYSTEM BUS SYSTEM TIMERS DMA FLOATING POINT IIC CONTROLLER SH CONTROL SH MUX CONTROL SH BUS cache INTERRUPTS PROCESSOR JTAG 8 GPIO SCANHEAD ULTRASOUND DATA PATH VIDEO AUDIO ECG IIC BUS DATA CONTROL Figure 4.
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. Figure 4.
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 protection 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.
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.
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.
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. Figure 5.1 shows an assert screen. The assert information required is the information listed on the “C:” line and the “D:” line.
DICOM Table 5.2: DICOM Troubleshooting Error Message Tiller Error Code Cause Troubleshooting Socket communication failed TSOCKET_CONNECT_FAILURE Invalid network configuration. Wrong port number. Application is not running. Printer is offline. Using Ping, verify that the Printer/Archiver is connected. • If Ping fails, check the devices IP address, Edge IP address, Subnet mask, and Gateway IP address. • If Ping is OK, use Verify to check if device is available.
38 Chapter 5: Troubleshooting
Chapter 6: Replacement Procedures Caution: Always use correct ESD procedures. ESD damage is cumulative and may not be noticeable at first. Initial ESD symptoms may be slightly degraded performance or image quality. Caution: All fasteners should be torque to 5.5-inch pounds except where noted such as the Control Panel Subassembly which is should be torque to 3.0-inch pounds.
Screws (8x) Figure 6.1 System Bottom 3 After removing the EDGE Bottom Enclosure, remove the two screws located in Figure 6.2. Don’t forget these two screws to release the top enclosure. (Refer to both arrow lines in the figure to the left). Figure 6.2 Main Frame Bottom Caution: Use caution when removing the Top Enclosure area under the Display. This area is retained with an adhesive strip and using too much force will break the Top Enclosure requiring replacement.
Caution: Adhesive backing under this area. Lift front area first. Figure 6.3 System Control Panel View 5 Remove the 10 perimeter screws holding the Control Panel, carefully lift from under the Control Panel and slide forward. Refer to Figure 6.4. Screws (10x) Front Edge Figure 6.4 Control Panel Removal 6 Remove the 2 screws holding the Hinge Cover and remove per Figure 6.5.
Hinge Cover screws (2x) Figure 6.5 Hinge Cover Caution: When lifting the front edge of the Control Panel away from the Main Frame, lift under the Control Panel board. Do not lift by the rubber membrane. This can easily become detached from the Control Panel board and cannot be refastened! 7 8 9 Expose the underside of the Control Panel by lifting from under the front edge and hinge via the top edge toward the LCD display.
Screws (4x) Figure 6.7 Display Screws Display Replacement Display Replacement 1 Set the new Display Assembly in place. 2 Install the four hinge screws that hold the Display Assembly in place. Torque the screws to 5.5-inch pounds. 3 Place the Control Panel onto the EDGE frame. 4 Connect both Display Assembly cables (J6 “LCD OUT” & J8 “BL OUT”) to the Control Panel and (J5 “LCD IN” & J7 “BL IN”) from the Main PCBA to the Control Panel. 5 Connect both ribbon cables (J4 “SPI” & J9 “GAIN”).
Control Panel Subassembly Replacement Required Parts One of the following: Service Assembly Control Panel Warranty Service Assembly Control Panel P15618-01 Control Panel, EDGE, English P15630-01 Control Panel, EDGE, English P15621-01 Control Panel, EDGE, French P15631-01 Control Panel, EDGE, French P15622-01 Control Panel, EDGE, German P15632-01 Control Panel, EDGE, German P15623-01 Control Panel, EDGE, Italian P15633-01 Control Panel, EDGE, Italian P15624-01 Control Panel, EDGE, Spanish P15634-0
Control Panel Replacement Control Panel Replacement 1 Place the new Control Panel onto the EDGE frame and line-up the holes as per Figure 6.8. Line up these holes with the holes in the core before tightening the screws otherwise top enclosure is difficult to fit. Figure 6.8 Control Panel Alignment 2 3 4 5 6 7 8 9 Expose the underside of the Control Panel by lifting from the front edge and hinge via the top edge toward the LCD display.
• Nest Frame Assembly, M-Turbo (Compatible with EDGE system): • P07750 Nest Frame Assembly • P00364 Connector, Interposer (8x) • P03833 Shield, Perimeter, Short (2x) • P03834 Shield, Perimeter, Long (2x) • P00924 Screw, Shoulder, Thrust Plate (4x) • P00353 Wear Plate • P00646 Spring, Thrust Plate, .047 wire (4x) • P08200 Socket Head Cap Screw, M2.5-.45x10mm (4x) Required Tools • • • • • • #1 Phillips screwdriver #2 Phillips screwdriver Torque screwdriver, 2.0-10.0 inch pounds (0.23-1.
Speaker Replacement Required Part • P03872 Speaker Assembly Caution: Use caution when removing the left speaker connector to prevent damage to the Main PCB A components around the connector. Speaker Replacement 1 Press on the connector release and pull the connector out of the receptacle. 2 Gently pry off the retaining clip with a flat bladed pry tool. See Figure 6.10. 3 Replace the speakers by reversing steps 1-2. Connector Speaker Retaining Clip Figure 6.
Power Supply PCBA Replacement Required Part • P08850 Service Assembly, Power Supply, M-Turbo (Compatible with the EDGE system) Power Supply Removal 1 Remove the 7 long screws and 2 short screws holding the Power Supply Shield. Please note the location of the 2 short screws. See Figure 6.11. Power Supply shield Long Screws (7x) Short Screws (2x) Figure 6.11 Power Supply Shield 2 3 Gently lift the Power Supply PCBA away from the Main PCBA as shown in Figure 6.12.
SD Card Daughter-card Required Parts • P10168 SD Card, 2GB (4 required) • P07442 SD Card Daughter-card SD Card Daughter-card Removal 1 Remove the 1 long screw holding from the SD Card Daughter-card. See Figure 6.13. USB Extension PCB SD Card Daughter-card alignment pins Long Screw (1x) Note: Kapton tape is used to retain SD Card in place. Figure 6.13 SD Card Daughter-card 2 Gently lift the SD Card Daughter-card straight up away from the Main PCBA.
USB Extension PCB Assembly Replacement Required Part • P14727 USB Extension PCB Assembly USB Extension PCB Assembly Removal Note: Please proceed to the Main PCBA Replacement section as all the steps detailed to replace the Main PCBA will require the removal of the USB Extension PCB Assembly. Main PCBA Replacement Main PCBA Removal 1 Remove the Power Supply PCBA and SD Card Daughter-card as described in the previous steps.
Screws (5x) Screws (2x) Figure 6.15 Main PCBA Screws 5 6 7 Turn the system over. Remove the 4 Socket Head Cap Screws as shown in Figure 6.16. This releases the Nest Frame and will allow the Main PCBA to be removed. As you remove the nest frame assembly from the PCBA, tilt the PCBA and enclosure to almost vertical to avoid spilling the Interposer Connectors from the assembly. Note: The Nest Frame is keyed onto the Main PCBA via two smaller and two larger hole sizes.
Main PCBA Replacement Replace the Main PCBA by following the reverse of the removal procedure. Do not tighten all the screws until everything is in place. 1 Connect the USB Extension PCB Assembly to the Main PCBA. 2 Replace the Main PCBA. 3 Reinstall the Fan Assembly. 4 Reinstall the Nest Frame Assembly. The Nest Frame Socket Head Cap Screws should be torque to 4.5-inch pounds. Caution: The Nest Frame is keyed onto the Main PCBA via two smaller and two larger hole sizes.
Chapter 7: 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 55.
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: To avoid electrical shock, before cleaning, disconnect the system from the power supply or remove from the mini-dock or docking system. WARNING: To avoid infection always use protective eyewear and gloves when performing cleaning and disinfecting procedures.
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.
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 remove 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.
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.
58 Chapter 7: Maintenance
Chapter 8: 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 the Gammex 403GS Soft Tissue Phantom or the Gammex 413A Multipurpose Phantom. A .7db/cm phantom is recommend but not required.
Basic Operational Tests Basic System Operation Tests 1 2 3 4 5 6 7 8 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.
Axial Measurement Accuracy Note: Measurements must be performed while the image is frozen. Set Up Axial Measurement Accuracy 1 2 3 4 5 6 Test Axial Measurement Accuracy 1 2 Acquire the image. Press the Freeze key. Press the 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.
Penetration The penetration measurement 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.
Color Power Doppler (CPD) Test CPD 1 2 3 4 5 6 Connect any transducer. Press the Color key. A Region of Interest (ROI) box is displayed on top of the grayscale image. 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. Gently tap the face of the transducer and observe that the ROI box fills with color information.
Pulsed Wave (PW) Doppler Imaging Test PW Doppler Imaging 1 2 3 4 5 6 7 Attach the P21x transducer. Press the Doppler key for the Doppler sample gate. 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 the sound from the speakers. Press the Freeze key and then save the image.
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 1 2 3 4 5 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.
66 Chapter 8: Performance Testing
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 Table A.
Control Panel Table A.
Main PCBA 1 5 4 3 2 Table A.3: Main PCBA Item Part Number Description 1 P15615 P15617 V15615 V15617 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.
Miscellaneous Parts Table A.4: Miscellaneous Parts Part Number Description Cables (images are not to scale) P02308 FFC, 12 Position Jumper, 0.5 Pitch, 3” Length (3” Flat Flex Cable) Note: This cable is used in two locations on the Control Panel PCB. 70 P14729 Cable Assy, Main to Control Panel PCB, Video P14747 Cable, Main To Control Panel PCB, Backlight P15410 FFC, 12 Position, 0.
Table A.4: Miscellaneous Parts Part Number Description Other Electrical Parts P02312 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.
Table A.4: Miscellaneous Parts Part Number Description Mechanical/Cosmetic Parts See Note Bottom Enclosure Note: 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.
Table A.4: Miscellaneous Parts Part Number Description P15305 Hinge Cover P16156 Service Assembly, EDGE Top Enclosure P15304 Enclosure, Middle, Machined, EDGE P07885 Thermal Pad, 1.00 x 1.00 x 0.100” (Used with P15304 & P15615 - requires 4) P07886 Thermal Pad, 0.35 x 0.35 x 0.
Transducer Nest Frame Assembly 7 1 6 2 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 P00364 Connector, Interposer (8x) 3 P03833 Shield, Perimeter, Short (2x) 4 P03834 Shield, Perimeter, Long (2x) 5 P00924 Screw, Shoulder, Thrust Plate (4x) 6 P00353 Wear Plate not shown P00646 Spring, Thrust Plate, .047 wire (4x) 7 P08200 Socket Head Cap Screw, M2.5-.
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.
Service Event Report Form Service Event Report Choose a Service Type Choose a Part Status Instructions on reverse Service Type (check one) Out of Box Failure Warranty Service Out of Warranty Service Enter complete contact information For SonoSite Use O Parts Status (check one) No parts necessary for this repair. Service Event Report for your information.
Service Event Report Instructions Instructions for completing the Service Event Report Sections highlighted in yellow must 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 x Out of Box Failure: the item has arrived from SonoSite with failures.
Returning Products to SonoSite You will be asked to provide the following information: • Contact name and phone number • Product name • Serial number • Description of the problem Shipping Instructions Please contact SonoSite to get a return material authorization number (RMA). Contact SonoSite before returning any product. The shipping address for all returned products is: SonoSite, Inc.
INDEX Numerics 2D performance tests axial measurement accuracy 61 image quality 61 lateral measurement accuracy 61 penetration 62 A ALARA 13 assert code 36 assistance, customer 1 B battery clean 56 safety 12 specifications 6 battery charging test 65 biological safety 13 bottom enclosure replacement 52 C cables clean and disinfect ECG 57 cautions, definition 1 clean battery 56 ECG cable 57 footswitch 56 LCD screen 54 system 54 transducers 55 cleaners, recommended 53 control panel subassembly replacement 4
H humidity limits 5 I image quality verification test 64 review 65 L LCD screen clean 54 M main PCBA failures 36 main system disassembly 45 middle machined enclosure 52 P performance tests 2D 60 battery 65 CPD 63 CW 64 M-Mode 63 overview 59 printer 65 PW 64 THI 63 Velocity Color 62 video output 65 periodic maintenance 53 power supply PCBA replacement 48 pressure limits 5 printer test 65 product failures 75 R replacement parts list 67 ordering 74 return material authorization number (RMA) 78 returning p
storage specifications equipment 5 subassembly replacement 35 system clean and disinfect 54 measurement accuracy 61 overview 21 T temperature limits 5 theory of operation 22 transducer clean and disinfect 55 disinfect 55 U USB extension PCB replacement 50 user guide, conventions used 1 V video output tests 65 W warnings, definition 1 81
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P15644-02 *P15644-02*
