FujiFilm SonoSite sII Service Manual
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FujiFilm SonoSite sII Service Manual

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  • Page 2 FUJIFILM is a registered and unregistered trademark of FUJIFILM Corporation in various jurisdictions. The FUJIFILM SonoSite ultrasound system(s) referenced in this document may be covered by one or more of the following U.S. patents: US 8,861,822; US 8,858,436; US 8,834,372; US 8,805,047; US 8,439,840; US 8,398,408; US 8,355,554; US 8,216,146; US 8,213,467; US 8,147,408;...

  • Page 3: Table Of Contents

    Introduction ..................1 Audience ....................1 Contact Information ................1 Conventions ..................2 Labeling symbols..................2 Specifications ..................7 System Specifications ................7 System Dimensions................7 Display Dimensions................7 Environmental limits ................7 Operating (system, battery, and transducer)........7 Shipping and storage (system and transducer)........7 Shipping and storage (battery) .............7 Electrical specifications ................7 Battery specifications ................8 Imaging Modes..................8 Image and Clip Storage................8...
  • Page 4 Battery Charger..................31 DICOM ....................31 Troubleshooting................. 33 System and Subsystem Diagnosis............33 System Repair..................34 Test Equipment ..................34 Failure (Assert) Codes ................. 34 Verifying a System Assert Code ............34 DICOM ....................35 User Interface..................36 Battery....................36 Replacement Procedures ..............
  • Page 5 User Interface Components ..............65 Parts Unique to STC Systems..............66 Enclosure Parts ..................67 Transducer Nest Frame Assembly............68 Ordering Replacement Parts..............68 Service Event Reporting..............69 Service Event Report Form ..............70 Service Event Report Instructions ............71 Returning Products to FUJIFILM SonoSite ..........72 Shipping Instructions ................72...

  • Page 7: Introduction

    Questions and comments are encouraged. FUJIFILM 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 the problem. If the problem is not covered here, contact FUJIFILM SonoSite Technical Support as follows: Technical Support (USA, Canada)

  • Page 8: Conventions

    Conventions These conventions are used in this service manual: • A WARNING describes precautions necessary to prevent injury or loss of life. • A Caution describes precautions necessary to protect the products. • Numbered steps must be performed in a specific order. •...
  • Page 9 Table 1: Labeling Symbols (Continued) Symbol Definition 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 Manufacturer Direct Current (DC) Do not get wet. Do not stack over 2 high. Do not stack over 5 high.
  • Page 10 Handle transducer with care. To avoid tipping, do not move the system using the handle on the front of the SonoSite SII ultrasound system. When moving the system, push the stand using the tray assembly. Type BF patient applied part...
  • Page 11 Chinese national standards for many products sold in the People’s Republic of China. Maximum weight load WARNING: Connect Only WARNING: Connect Only Accessories and Peripherals Accessories and Recommended by FUJIFILM SonoSite Peripherals Recommended by FUJIFILM SonoSite Chapter 1: Introduction...
  • Page 12 Chapter 1: Introduction...

  • Page 13: Specifications

    Chapter 2: Specifications System Specifications This chapter contains information regarding system specifications and accessory compatibility. The information applies to the ultrasound system, transducers, accessories, and peripherals. System Dimensions Height: 17.6 in. (44.7 cm) Max height with stand: 59.5 in. (151 cm) Min height with stand: 49 in.

  • Page 14: Battery Specifications

    The number of images and clips you can save varies with imaging mode and file format. Compatible accessories and peripherals FUJIFILM SonoSite has tested the SonoSite SII ultrasound system with the following accessories and peripherals and has demonstrated compliance to the requirements of IEC60601-1-2:2007.
  • Page 15 Accessories and peripherals compatible with SonoSite SII ultrasound system (Continued) L52x transducer (Vet) V00033 7.9 ft/2.4 m P10x transducer P07696 6.0 ft/ 1.8m P11x transducer P16665 6.5 ft/2.0 m Bar code scanner P14166 4.8 ft/1.5 m PowerPack P13122 — Battery for PowerPack P13123 —...
  • Page 16 Chapter 2: Specifications...

  • Page 17: Safety

    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.
  • Page 18 Connection of accessories and peripherals not recommended by FUJIFILM SonoSite could result in electrical shock. Contact FUJIFILM SonoSite or your local representative for a list of accessories and peripherals available from or recommended by FUJIFILM SonoSite.

  • Page 19: Electrical Safety Classification

    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.

  • Page 20: Battery Safety

    FUJIFILM SonoSite or your local representative. • Store the battery between -20°C (-4°F) and 60°C (140°F). • Use only FUJIFILM SonoSite batteries. • Do not use or charge the battery with non-FUJIFILM SonoSite equipment. Only charge the battery with the system. Chapter 3: Safety...

  • Page 21: Clinical Safety

    MI and TI. WARNING: FUJIFILM SonoSite does not currently recommend a specific brand of acoustic standoff. If an acoustic standoff is used, it must have a minimum attenuation of .3dB/cm/MHz.

  • Page 22: Electromagnetic Compatibility

    WARNING: The Sonosite SII ultrasound system should not be used adjacent to or stacked with other equipment. If such use occurs, verify that the SonoSite SII ultrasound system operates normally in that configuration.

  • Page 23: Separation Distance

    Recommended separation distances between portable and mobile RF communications equipment and the SonoSite SII ultrasound system The SonoSite SII ultrasound system is intended for use in an electromagnetic environment in which radiated radio frequency (RF) disturbances are controlled. The customer or the...

  • Page 24: Guidance And Manufacturer's Declaration

    Other equipment, even equipment that complies with CISPR emission requirements, can interfere with the SonoSite SII ultrasound system. The SonoSite SII wireless adapter 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: •...
  • Page 25 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Continued) The SonoSite SII ultrasound system is intended for use in the electromagnetic environment specified below. The customer or the user of the SonoSite SII ultrasound system should assure that it is used in such an environment.
  • Page 26 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 FUJIFILM SonoSite ultrasound system is used exceeds the applicable RF compliance level above, the FUJIFILM SonoSite ultrasound system should be observed to verify normal operation.

  • Page 27: Immunity Testing Requirements

    Immunity testing requirements The SonoSite SII ultrasound system complies with the essential performance requirements specified in IEC 60601-1-2 and IEC 60601-2-37. Results of immunity testing show that the SonoSite SII ultrasound system meets these requirements and is free from the following: •...

  • Page 28: Airborne Equipment Standards

    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 (2014). AAMI/ANSI/ISO 10993-11, Biological evaluation of medical devices—Part 11: Tests for systemic toxicity (2006).

  • Page 29: System Overview

    Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. The SonoSite SII utilizes AES-256 encryption with the internal SD card for the purpose of encrypting Protected Health Information (PHI). The system specific encryption key is programmed at the factory and cannot be changed.
  • Page 30 External power Figure 4.1 SonoSite SII 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.

  • Page 31: Description Of Operating Modes

    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 Control Group. The power subsystem includes the battery pack and battery charging electronics.

  • Page 32: Additional System Feature Performances

    For details, please see the SonoSite SII User Guide. Measurement and The system offers a variety of measurements and calculations, specific to Calculation exam type and transducer.

  • Page 33: Front End Overview

    Front End Overview The Front End is designed to support various imaging modalities such as 2D and Color 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.

  • Page 34: Back End Overview

    The SonoSite SII Back End subsystem is shown in the figure below. Figure 4.3 Back End Subsystem Block Diagram The Back End Subsystem performs processing encompassing three main data domains, acquisition data, raster data, and video data.

  • Page 35: Control Subsystem

    Communication interfaces consists of an Ethernet interface, USB port, two general purpose serial bus interfaces, and the IIC bus. The SonoSite SII control architecture is an open architecture. It supports func- tionality extension through the incorporation of the PCI bridge to the PCI bus. Functionality may be added by adding to the PCI Bus.

  • Page 36: Power Supply And Control

    Power Supply and Control The SonoSite SII 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.

  • Page 37: Battery Charger

    Battery Charger The charge circuitry is in the external AC/DC Adapter as shown in the following block diagram. Output Cable SYSTEM POWER SUPPLY / BATTERY CHARGER +15VDC Voltage Source VCHG VBAT+ Current Limited Current Universal Voltage Source Sense Input Ferrite / Line Common Mode Choke...
  • Page 38 Chapter 4: System Overview...

  • Page 39: Troubleshooting

    Note: If the system requires repair, certain steps must be taken to remove patient data from the system prior to return to FUJIFILM SonoSite. To accomplish this, a Power-0 Reset must be performed whenever possible (certain conditions may prevent this, such as a system that fails to power on).

  • Page 40: System Repair

    FUJIFILM SonoSite. Component level repair of Printed Circuit Board Assemblies is performed only at the FUJIFILM SonoSite repair facility. Replacement of board level components by unauthorized service facilities voids the FUJIFILM SonoSite warranty and will prevent receipt of credit on a returned assembly.

  • Page 41: Dicom

    Image settings. failed E.g,. Color (RGB) or Grayscale (Monochrome) DICOM TDNETWORK_OPEN_FAILURE Device does not Verify that SonoSite SII AE Title network recognize or IP address is correctly communication SonoSite SII, configured on the failed rejects Printer/Archiver.

  • Page 42: User Interface

    User Interface Table 5.3: User Interface Troubleshooting Problem Cause Troubleshooting No Display Faulty Display Feed video from back of system to external monitor or Main PCBA • If the video is not present on the external display, the Main PCBA is likely at fault. •...

  • Page 43: Replacement Procedures

    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 torqued to 5.5-inch pounds except where noted. Required Tools •...
  • Page 44 2 Use X-Acto knife or equivalent to remove screw caps from the Top Cap Assembly and Bottom Cap as shown in Figure 6.1. Figure 6.1 Screw Cap Removal 3 Remove five screws each from Top Cap Assembly and Bottom Cap. Remove additional two screws from back of Top Cap Assembly also shown in Figure 6.1 4 Remove Top Cap Assembly and Bottom Cap.
  • Page 45 Figure 6.3 Handle Removal 8 Remove eight screws securing the Base Assembly to the User Interface as shown in Figure 6.4 Figure 6.4 Base Assembly Screw Removal 9 Carefully turn the system over so the User Interface is facing up and rotate the system so the bottom (dual fan) is pointing toward you.

  • Page 46: User Interface Parts Transfer

    Disconnect Figure 6.5 User Interface Removal Note: If the User Interface is removed for replacement, several parts need to be removed and installed on the new User Interface. Item Part Number Description Number P20814 Speaker Cable Assembly (x2) P21440 TGC PCBA P20492 Light Pipe P21082...
  • Page 47 Remove eight screws Remove three screws Remove screw enlarged view Figure 6.6 User Interface speaker, TGC and light pipe removal 3 Remove three screws from TGC and lift from midframe per Figure 6.6. 4 Remove screw from light pipe and remove from midframe. 5 With a 1/8 in screwdriver, remove ten Slide Lock Plates from sides of UI per Figure 6.7.

  • Page 48: Install User Interface

    6 Screwdriver is used to lift locking tab, allowing removal by sliding plate in direction of arrows. Figure 6.7 shows the proper orientation of the Slide Lock Springs. Make note of proper orientation before removal. UI Parts Installation 1 Reverse steps above starting with step 7. 2 Place Slide Lock Springs on Slide Plates before installation 3 Tighten the light pipe screw to 5.5 in-lbs 4 Tighten the TGC screws to 5.5 in-lbs.

  • Page 49: Base Assembly Disassembly For Repair And/Or Replacement

    Base Assembly Disassembly for Repair and/or Replacement All of the components shown in Figure 6.8, including the frame they are mounted on, are called the Base Assembly. The Base Assembly cannot be ordered but is referenced throughout these instructions. Removal of the User Interface as described in “User Interface Removal”...

  • Page 50: Required Tools

    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. Required Tools • #1 Phillips screwdriver • 1/4 inch flat blade screwdriver •...

  • Page 51: Back Enclosure Replacement

    Back Enclosure Replacement Contact SonoSite Technical Support if it is necessary to replace the Back Enclosure. Note: Ordering the Back Enclosure requires special handling due to the serial number label.. Back Enclosure Removal 1 Remove nine screws plus three securing the Mini-Dock as shown in Figure 6.10.

  • Page 52: Internal Mini-Dock Replacement

    2 For systems with STC, the STC cover needs to be placed in the blank port from the rear of the Back Enclosure. 3 Torque the four STC cover screws to 5.5 in-lbs. 4 Torque the nine screws securing the Mid-Frame Assembly plus three screws securing the Internal Mini-Dock to 5.5 in-lbs.

  • Page 53: Internal Mini-Dock Replacement

    Internal Mini-Dock Replacement 1 Perform steps for “Internal Mini-Dock Removal” on page 46 in reverse order. 2 Ensure one end of backlight cable is connected to the Internal Mini-Dock and the other to the Main PCBA. 3 Install Internal Mini-Dock on Main PCBA and connect 3 cables in Figure 6.11 DTC/STC Replacement Note: For simplification, only the procedure for DTC removal will be shown.

  • Page 54: Dtc Replacement

    2 Lift Mid-Frame Assembly and move nest frame assemblies out of the way. Be careful when moving nest frame assemblies as turning them over will cause the interposers to fall out. 3 Turn Mid-Frame Assembly over and orient per Figure 6.13 4 Remove five screws per Figure 6.13 5 Lift latch lever and rotate 90 degrees clockwise to disengage.

  • Page 55: Dual Fan Cable Assembly Replacement

    6 Hold Nest Frame in the palm of your hand and put into place on the underside of the Mid-Frame Assembly using care to key it properly per Figure 6.14. 7 Install four screws as shown in Figure 6.12 and torque to 5.5 in-lbs. 8 Repeat steps 6 and 7 for other nest frame assembly.

  • Page 56: Power Supply Pcba Removal

    Power Supply PCBA Removal Required Parts • P19909-XX Service Assembly, Power Supply PCBA • V19909-XX Vet Service Assembly, Power Supply PCBA Power Supply PCBA Removal 1 Remove Seven long screws and two short screws securing the digital shield lid. Please note the location of the 2 short screws as seen in Figure 6.16 .

  • Page 57: Sd Card Replacement

    Power Supply connector underneath mates Power Supply PCBA to the Main PCBA. Power Supply PCBA Figure 6.17 Power Supply PCBA SD Card Replacement Note: The SD card is not field replaceable as the encryption can only be set at the factory. Each Main PCBA is matched to their SD card and for this reason cards are also not interchangeable between systems.

  • Page 58: Main Pcba Replacement

    8 Remove eight screws as shown in Figure 6.18. 9 Lift Main PCBA from Mid-Frame Main PCBA Replacement 1 Place Main PCBA on Mid-Frame and install seven screws as shown in Figure 6.18. Do not tighten the screws. 2 Tip Mid-Frame onto the side and Install Nest Frame Assembly with four screws as shown in Figure 6.19.

  • Page 59: Mid-Frame Replacement

    Remove screws (4x) Figure 6.19 Nest Frame Removal Mid-Frame Replacement Required Parts • P20501 Mid-Frame, SII • P07885 Thermal Pad, 1.00 x 1.00 x 0.100” (4 Required) • P07886 Thermal Pad, .035 x .035 x 0.100: (14 Required) Mid-Frame Replacement 1 Follow all the above procedures to remove all PCB assemblies and hardware fastened to the original Mid-Frame.
  • Page 60 Chapter 6: Replacement Procedures...

  • Page 61: Maintenance

    No periodic or preventive maintenance is required for the system, transducers, or accessories other than cleaning and disinfecting the transducer after every use. For cleaning and disinfecting, please reference the SonoSite SII User Guide. For a complete list of approved cleaners and disinfectants, please visit www.sonosite.com.
  • Page 62 Chapter 7: Maintenance...

  • Page 63: Performance Testing

    To obtain 2D images, FUJIFILM SonoSite recommends using the Gammex 403GS Soft Tissue Phantom or the Gammex 413A Multipurpose Phantom. A .7db/cm phantom is recommended but not required.

  • Page 64: Basic Operational Tests

    Basic Operational Tests Basic System Verify that the correct transducer name appears in the upper right corner of the system Operation display. Tests 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.

  • Page 65: Axial Measurement Accuracy

    Measurement tap the Freeze button. Accuracy tap Calipers. The calipers appear on the image display. (See the SonoSite SII Ultrasound System User Guide, if necessary, for caliper operation.) Use the touchpad or touchscreen to position the active caliper. Select the other caliper in either of the following two methods.

  • Page 66: Penetration

    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.

  • Page 67: Color Power Doppler (Cpd)

    Color Power Doppler (CPD) Test CPD Connect any transducer. tap the Color button. A Region of Interest (ROI) box is displayed on top of the grayscale image. tap the Color button to switch to CPD. “CPD” should be annotated in the top left corner of the display.

  • Page 68: Printer

    Printer The printer test is an optional test that requires a video printer to be connected to the system under test. Skip this test if a printer is not available. Test Printer Connect a video output and print control cable from the rear of the system to the Operation printer.

  • Page 69: Replacement Parts List

    Appendix A: Replacement Parts List The following tables contain all the field-replaceable parts for the S II ultrasound system. Quantities are one unless otherwise noted. Base Assembly Components Table 1: Base Assembly Components Item Part Number Description Number P22444-XX Service Assembly, Internal Mini-Dock, SII V22444-XX Vet Service Assembly, Internal Mini-Dock, SII P21168-XX...

  • Page 70: Additional Base Assembly Components

    Additional Base Assembly Components Table 2: Additional Base Assembly Components Item Part Number Description Number P20816 Cable, Main PCBA to Gain P21844 Dual Fan Cable Assembly P20501 Mid-Frame P21193 Cable Assembly, Speaker Extension (2x) P20818 Cable, LCD Video P20819 Cable, Control Board to I/O P20817 Cable Main PCBA to I/O P20820...

  • Page 71: User Interface Components

    User Interface Components Table 3: User interface Components Note: If the User Interface is replaced, items 2‐8 below must be transferred from the old to the new. Item Part Number Description Number P20475-XX Service Assembly, User Interface, SII (supports all languages) V20475-XX Vet Service Assembly, User Interface, SII (supports all languages) P20814 Speaker Cable Assembly (x2) P21440 TGC PCBA P20492 Light Pipe...

  • Page 72: Parts Unique To Stc Systems

    Parts Unique to STC Systems Table 4: Parts Unique to STC Systems Item Part Number Description Number P20662-XX Service Assembly, Single Transducer connect (STC) Note: Similar to DTC except only has parts and components for one port. The note above concerning nest frame assemblies applies to STC. P20472 STC Cover Appendix A: Replacement Parts List...

  • Page 73: Enclosure Parts

    Enclosure Parts Table 5: Enclosure Parts Item Part Number Description Number P20470 Bottom Right Extrusion 2 (other side, P20471 Bottom Left Extrusion not shown) P20465 Back Enclosure P20473 Handle P20468 Top Extrusion (x2) P20467 Bottom Cap P21624 Top Cap Assembly (contains power button) P21155 Screw Cover for Top/Bottom Cap (x10) Appendix A: Replacement Parts List...

  • Page 74: Transducer Nest Frame Assembly

    Transducer Nest Frame Assembly Table 6: Nest Frame Assembly Item Part Number Description Number P15551 Screw, PNHD, Phillips, M3-.5X8MM P00353 Wear Plate P00924 Screw, Shoulder, Thrust Plate (4x) P00646 Spring, Thrust Plate, .047 wire (4x) P03834 Shield, Perimeter, Long (2x) P03833 Shield, Perimeter, Short (2x) P00364...

  • Page 75: 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 FUJIFILM 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: Fujifilm SonoSite, Inc.

  • Page 76: Service Event Report Form

    Service Event Report Form Service Event Report Instructions on reverse Service Type Parts Status For FUJIFILM SonoSite Use Only (check one) (check one) No parts necessary for this repair. Service † † Out of Box Failure Service Request Event Report for your information.

  • Page 77: Service Event Report Instructions

    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 Sections highlighted in yellow must be completed for SonoSite to accept the Service Event Report. required for certain circumstances you will be advised.

  • Page 78: Returning Products To Fujifilm Sonosite

    • Serial number • Description of the problem Shipping Instructions Please contact FUJIFILM SonoSite to get a return material authorization number (RMA). Contact FUJIFILM SonoSite before returning any product. The shipping address for all returned products is: FUJIFILM SonoSite, Inc.
  • Page 79 Index 2D performance tests axial measurement accuracy lateral measurement accuracy penetration accessories and peripherals ALARA Assert Code battery specifications battery charging test battery safety battery troubleshooting clinical safety conventions used DICOM troubleshooting electrical safety electromagnetic compatibility Electrostatic Discharge (ESD) Environmental limits equipment safety error message Failure Reporting...
  • Page 80 Power-0 Reset Preventive Maintenance Product Failures replacement parts list ordering replacement procedures Back Enclosure Dual Fan Cable Assembly Internal Mini-Dock Main PCBA Mid-Frame Power Button PCA Power Supply PCBA SD card User Interface Return Material Authorization number (RMA) Returning Products safety electromagnetic compatibility Service Event Report...
  • Page 82 P22358-01 *P22358-01*...

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