NanoMaxx Service Manual
Contents
1. A WARNING describes precautions necessary to prevent injury or loss of life A Caution describes precautions necessary to protect the products e Numbered steps must be performed in a specific order Bulleted lists present information in list format but do not imply a sequence Labeling symbols are in the user guide 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 the problem If the problem is not covered here contact SonoSite Technical Support as follows Technical Support USA Canada phone 1 877 657 8118 Technical Support fax 1 425 951 6700 Technical Support e mail service sonosite com SonoSite Web site www sonosite com gt Support 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 e mail service pesonosite com Chapter 1 Introduction 1 Chapter 1 Introduction Chapter 2 System Overview About the System The SonoSite NanoMaxx high resolution ultrasound system is a portable 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 Color Power Doppler C2. Image and Clip Storage The number of images and clips you can save varies with imaging mode and file format The internal storage can save approximately 40 patients with 50 images each Accessories Hardware Software and Documentation Battery Carry Case Kensington Security Cable Needle Guides L25n only Power supply SonoCalc IMT Software 4 1 V Universal Stand System User Guide CD Standard Hardcopy optional System AC PowerCcord 10 ft 3 1 m VESA Compliant Mounting Video and printer cables Cables See the NanoMaxx Ultrasound System User Guide or the V Universal Stand User Guide for information on cables Peripherals Peripherals include the following medical grade conforming to the requirements of EN60601 1 and non medical grade commercial products Manufacturer s instructions accompany each peripheral System setup instructions are in the NanoMaxx Ultrasound System User Guide Instructions for using peripherals with the system are in the applicable SonoSite accessory user guide Medical Grade Black and white printer Non Medical Grade 2GB USB Memory Stick Chapter 2 System Overview Temperature Pressure and Humidity Limits Note The temperature pressure and humidity limits apply only to the ultrasound system and transducers Operating Limits System battery and transducer e 10 40 C 50 104 F 15 9576 R H 700 to 1060hPa 0 7 to 1 05 ATM Shipping Storage Limits System and transducer e 35 65
3. C 31 149 F 15 95 R H e 500 to 1060hPa 0 5 to 1 05 ATM Shipping Storage Limits Battery e 20 60 C 4 140 F 0 95 R H For storage longer than 30 days store at or below room temperature 500 to 1060hPa 0 5 to 1 05 ATM Electrical Power Supply Input 100 240 VAC 50 60 Hz 2 0 A Max 100 VAC Power Supply Output 1 15 VDC 5 0A Max system Power Supply Output 2 12 VDC 2 3A Max battery Combined output not exceeding 75W Battery 6 cell 11 2 VDC 5 2 amp hours rechargeable lithium ion battery pack Run time is up to 2 hours depending on imaging mode and display brightness Electromechanical Safety Standards 8 EN 60601 1 1997 European Norm Medical Electrical Equipment Part 1 General Requirements for Safety EN 60601 1 1 2001 European Norm Medical Electrical Equipment Part 1 General Requirements for Safety Section 1 1 Collateral Standard Safety Requirements for Medical Electrical Systems EN 60601 1 2 2001 European Norm Medical Electrical Equipment Part 1 2 General Requirements for Safety Collateral Standard Electromagnetic compatibility Requirements and tests EN 60601 2 37 2001 Amendment A1 2005 European Norm Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment CAN CSA C22 2 No 601 1 M90 Canadian Standards Association Medical ElectricalEquipment Part 1 General Requirements for Safety including CSA 601 1 Supplement 1 1994 an
4. The Livescan test performed is at the discretion of the sonographer and will represent their acceptance of a successful service event Review all saved images and verify that the images are displayed properly Test Printer Operation Optional 1 2 3 Verify proper printer type is configured 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 Battery Charging Test Battery Charging Operation 1 2 3 Insert a battery into the system and remove the power cord from the NanoMaxx dock 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 extinguishes from right to left as the battery discharges Note The Power and Sleep delay settings in the Audio Battery setup page should be selected to Off to properly perform this test The battery may take 1 2 hours to discharge Attach the AC power cord to the power connector Press the power key to turn the system on Note that the battery indicator indicates that the battery is charging The sections of the battery indicator will light sequentially from left to right as the battery charges Video Output 28 Caution Use only the recommended video monitor or printer when verifying t
5. 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 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 Provider Reference a unique number used by the Provider to track Service Event Reports Any format is acceptable Company the name of the Distributor or authorized repair facility Address the address replacement parts will be shipped to Date Reported the date the failure was reported to SonoSite Phone Number the phone number to contact the service technician Fax Number the fax number to contact the service technician 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 de
6. System on Denen 29 Miscellaneous System Components rmasiinrocacanidcrniciscnaricscinnaiads nennen nenne 31 Ordering nc pon 31 Other System Components ii id ies 30 Replacement Procedures Back End PCB p 18 Backlight Inverter PER 21 Front End PCOB E 16 Ee REN 22 Power Supply PEB ic 17 Le iii 20 Return Material Authorization number ORMA EN 36 Retire OG UES tirita 36 S Service Event Rail 33 Shipping instructions a ee 36 Specifications ACES ee 7 Drac M 8 Display DIMENSIONS ege 6 Image and Clip m o EN a e a ae 7 Imaging Modes anne ee rue 7 System Dimensions Mm 6 Transduser an E 6 T Technical Pollen ee u 11 Temper lee een 8 PP A 25 Theory Of Operation ME 3 E 13 Transducers ati 6 38 Bi SonoS te P12706 01 ACA TAA A
7. rtt t testet ennt ctas tetti ideados Chapter 5 Performance Testing CV ORV IW see di Test Eg ipmei EE Set Up Performance Tests ese eo reet iori ie nennen Basic Operational Tests scccccseecessossesonessnsssovsvessnssssnovessnecaseceoseenssenensensnevonssensaseasasrossesosons 2D Performance Testi dai Additional Performance Tests Appendix A Replacement Parts List Major System Component EE 29 Other System Components sse nennen enne nnne nennen 30 Miscellaneous System Components sse nene 31 Ordering Replacement Parts eene nene 31 Appendix B Service Event Reporting Service Event Report Form te ie detienen Sra ere ideis cen EENEG 34 Service Event Report Instructions sse 35 Returning Products to SOMOS eric conocio insistente iii 36 Chapter 1 Introduction Before servicing the NanoMaxx 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 NanoMaxx Ultrasound System User Guide for additional information regarding safety system controls operation capabilities and specifications Audience The intended audience of this manual is properly trained field and in house service personnel Conventions These conventions are used in this service manual
8. strap Chapter 4 Replacement Procedures 13 Rear Cover Removal Removal of the Rear Cover is required to access all other system components 1 Remove the battery from the system 2 Remove the six screws from the Rear Cover as shown in Figure 4 1 Caution There are several cables connecting the top and bottom halves ofthe system Use caution when removing the rear cover to prevent cable or PCB damage Battery removed Screws 6x Figure 4 1 Rear Cover Removal 3 Disconnect the three cables connecting the upper and lower halves of the system as show in Figure 4 2 Disconnect ae 4 Figure 4 2 Disconnecting Cables Rear Cover Installation 1 Reconnect the three cables 2 Insert the top of the Rear Cover under the top cap and press down to mate with the Front Enclosure 3 Install the six screws removed from the Rear Cover and torque to 5 5 inch pounds 62 newton centimeters 4 Install the battery 14 Chapter 4 Replacement Procedures Major System Components Fan Battery Well Power Supply PCB shown with shield Front End PCB removed Back End PCB Nest Frame Assembly Figure 4 3 Major System Components Chapter 4 Replacement Procedures 15 Front End PCB Replacement Required Parts P12717 Service Assembly Front End PCB NanoMaxx Front End PCB Removal 1 Remove the Rear Cover as described in Rear Cover Removal on page 14 2 Remove the ten screws shown in Figure 4 4 BA s
9. 00000002 R6 0x40D3FE60 GROS R8 OxFFFFFFFF R9 0x00000001 Assert Code R10 0x007CEDBO R11 0x007CEDCC R12 0x4006370C SP 0x007CED74 LR 0x01010101 PC 0x40063738 PSR 0x40000010 Figure 3 1 Maintenance Screen with Assert Code 2 Press and release the Power button to power the system down It may be necessary to hold down the Power button as long as 10 seconds in some cases 3 Press the Power button again to power the system up If the system powers up normally it has recovered from the fault software assert and you may use the system e If the Assert Code remains corrective action must be taken usually replacement of the the Back End PCB 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 i e disconnect AC power and remove the battery 12 Chapter 3 Troubleshooting Chapter 4 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 Required Tools 1 and 2 Phillips screwdrivers 1 and 2 Flat Blade screwdrivers 3mm Allen Key 3 16 Nut Driver or equivalent wrench socket Kapton tape Torque screwdriver 2 0 10 0 inch pounds 23 110 newton centimeters Cotton swabs Q Tips Anti static mat amp wrist grounding
10. 0970 FR1589878 GB0875203 GB0881492 GB1175713 GB1180970 GB1180971 GB1589878 IT0815793 IT0881492 IT1175713 IT1589878 KR528102 KR532359 NO326202 NO326814 NZ542968 RCD000897368 0001 SP0815793 SP0881492 SP1589878 Patents pending P12706 01 04 2010 Copyright 2010 by SonoSite Inc All rights reserved Contents Chapter 1 Introduction Audience a Conventions EE Contact Informal decis Chapter 2 System Overview About the ys noi ia e iia Theory OF Operation sti irlandes dee derent ets tue System Specifications cserssssvsrcrssserssssessevessnerscnonsesevsecsensesesessessvendacesssesesessesseessesesasensoees Chapter 3 Troubleshooting Periodic Maintenance nina kununu Technical Bulletins EE System and Subsystem Diagnose Syst m E OPERAN Test Equipment ssl alitas Failure Assert Codes EE Chapter 4 Replacement Procedures Required KEE Rear Cover Removal EE Rear Cover Installation ccccccccccssecssseessecescesseseseecessecsseesecssesesaeceeecsssecsacessecssssesaeeeneess Major System Components Front End PCB Replacement retenti ettet rient trist ert nba eerte rotos Power Supply PCB Replacement sse eene nnn ener Back End PCB Replacement eterne ester ttes terti rerit od esaet Other Major System Components eene User Interface PCB Replacement ENEE Display Backlight Inverter BLI PCB Replacement sese LCD Replacement
11. 8 Service Assembly Back End M Turbo NanoMaxx Back End PCB Removal 1 Remove the Rear Cover as described in Rear Cover Removal on page 14 2 Remove the Front End PCB as described in Front End PCB Removal on page 16 3 Remove the Power Supply PCB as described in Power Supply PCB Removal on page 17 4 Disconnect the Fan cable from the Back End PCB as shown in Figure 4 6 5 Remove the eight screws as shown in Figure 4 6 6 Remove the SD Card from the holder for use with the replacement PCB Fan Cable Connector P09037 M3 5x6mm screws 8x Figure 4 6 Back End PCB Replacement Back End PCB Installation 1 Install the SD card removed from old PCB into the replacement Back End PCB 2 Install the replacement Back End PCB into the frame 3 Install the eight screws and torque the screws to 5 5 inch pounds 62 newton centimeters Caution Inspect the Power Supply Shield to ensure that none of the contacts are bent Improper contact between the shield and the Power Supply Frame can cause image noise problems 4 Reconnect the fan cable to the Back End PCB as shown in Figure 4 6 5 Reinstall the Front End PCB as described in Front End PCB Installation on page 16 6 Reinstall the Power Supply PCB as described in Power Supply PCB Installation on page 17 7 Reinstall the Rear Cover as described in Rear Cover Installation on page 14 18 Chapter 4 Replacement Procedures Other Major System Components
12. CB 4 P09199 BLI Power Harness Inverter Cable Assy 5 P09895 Backlight Inverter Cover Shown partially removed 6 P08398 Display Isolation Damper Shoulder Screw 4x 7 P07477 Display Isolation Damper 4x 8 P09177 Display Housing 9 P09977 FFC 6 Cable Assy 10 P12329 User Interface PCB 11 P12755 Service Assembly Front Enclosure Enclosure only does not contain any ofthe parts listed above Not shown P09732 8 4 LCD Assembly Installed under item 7 Display Housing 30 Appendix A Replacement Parts List Miscellaneous System Components Table 3 Miscellaneous System Components Item Number Part Number Description 1 P09187 Encoder Knob Not shown P12889 Battery Ordering Replacement Parts To order parts contact SonoSite Technical Support See Contact Information on page 1 Appendix A Replacement Parts List 31 32 Appendix A Replacement Parts List 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 Rep
13. NanoMaxx Ultrasound System 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 NanoMaxx SiteLink SonoSite and the SonoSite logo are registered trademarks or trademarks of SonoSite Inc DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information 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 D456509 D461895 D509900 D538432 D544962 D558351 D559390 D591423 D592750 D592760 and by the following counterpart foreign patents AU727381 AU730822 CA2372158 CA2373065 CN ZL 97113678 5 CN ZL 98106133 8 CN ZL 98108973 9 CN ZL 200830007 734 8 DE60021552 0 DE60029777 2 DE60034670 6 DE69730563 5 DE6980539 6 DE69831698 3 DE60 2004 23 816 3 08 FR0815793 FR0875203 FR0881492 FR1175713 FR118
14. PD and Color Doppler Color or in a combination of these modes The system provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes System features include cine review image zoom labeling needle guidance measurements calculations and image storage review printing recording capabilities The system transducer is capable of exceeding a TI 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 Theory of Operation The NanoMaxx ultrasound system has seven 7 major functional groups Transducer Acquisition Subsystem Processing Subsystem Display Subsystem Control Subsystem User Interface Subsystem Power Subsystem Figure 2 1 shows the relationship of the functional groups Chapter 2 System Overview 3 AC Adapter 15V Nest FrontEnd FRM rn 50 PIN FE Port Replicator 2UsB i 4 Connectors H FUSED 3 3 3 3 vewn Back End u BE bid PO E 263 Bis i pip Ra UI PCB H i
15. creen to move the CPD 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 Gently tap the face of the transducer and observe that the ROI box fills with color information Press the Freeze key and then save the image Press the Freeze key again to return to live imaging Color Power Doppler CPD Test CPD 1 2 3 Connect any transducer Press the Color key A ROI box appears on top of the grayscale image Press the Color key on the left side of the display to switch to CPD CPD should be annotated on the Color CPD key Adjust the Depth control for minimum depth in the image 5 Adjust the Gain control so that color speckles appear just inside the ROI box Gently tap the face of the transducer and observe that the ROI box fills with color information Chapter 5 Performance Testing 27 Image Quality Verification Test Livescan Printer Products with replaced subassemblies or products that have been otherwise disassembled should undergo an Image Quality Verification Test Livescan The Image Quality Verification Test Livescan should be performed after successfully completing all applicable performance tests listed above The test is completed before returning the system to operation It is recommended that a certified sonographer perform the image quality verification
16. cture 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 the signaling of an error to the Control Group The power subsystem includes the battery pack and battery charging electronics Chapter 2 System Overv
17. curity and Privacy Chapter 2 System Overview 10 Chapter 2 System Overview Chapter 3 Troubleshooting This chapter contains information to help you correct problems with system operation and provides instructions on the proper care of the system transducer and accessories Periodic Maintenance There is no recommended periodic or preventive maintenance required for the system transducers or accessories There are no internal adjustments or alignments required There are no functions that require periodic testing or calibration Performance tests are described in Chapter 5 Performance Testing of this manual Performing maintenance activities 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 Technical Bulletins Product Technical Bulletins describing known system issues are periodically placed on SonoSite com Select Support and then follow the links to NanoMaxx Support Documents 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 call SonoSite Technical Support Table 3 1 Troubleshooting Subassemblies and Diagnostic Figures Subassemblies Diagnostic Figures or Table Display TBA Battery TBA Cont
18. d CSA 601 1 Amendment 2 1998 CEI IEC 61157 1992 International Electrotechnical Commission Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment UL 60601 1 1st Edition Underwriters Laboratories Medical Electrical Equipment Part 1 General Requirements for Safety Chapter 2 System Overview EMC Standards Classification EN 60601 1 2 2001 European Norm Medical Electrical Equipment General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests CISPR11 2004 International Electrotechnical Commission International Special Committee on Radio Interference Industrial Scientific and Medical ISM Radio Frequency Equipment Electromagnetic Disturbance Characteristics Limits and Methods of Measurement The Classification for the SonoSite system V Universal Stand accessories and peripherals when configured together is Group 1 Class A Airborne Equipment Standards RTCA DO 160E 2004 Radio Technical Commission for Aeronautics Environmental Conditions and Test Procedures for Airborne Equipment Section 21 0 Emission of Radio Frequency Energy Category B DICOM Standard NEMA PS 3 15 2000 Digital Imaging and Communications in Medicine DICOM Part 15 Security Profiles HIPAA Standard The Health Insurance and Portability and Accountability Act Pub L No 104 191 1996 45 CFR 160 General Administrative Requirements 45 CFR 164 Se
19. g 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 Attn Technical Support RMA 21919 30th Drive SE Bothell Washington 98021 USA 36 Appendix B Service Event Reporting Index A A ee 7 Airborne Equipment Standards EE 9 O a P EEE E asadas pad 12 C Contact Information 0ccccssecceaccccsesecccceccocestuncecceteccnenteunceeccceesnsetcunccccnsscccteccas 1 Conventions Used iet eser eee ria 1 Lef EE 1 D IIIe e EN 9 E Electromechanical Safety Standards sss 8 EMC Standards Classificados ENEE 9 F SE 12 Failure Reporting unten ee A AA AA A asia 33 H lv E 9 lovin c o ae ei in an ne iiS 8 P Performance Tests 2D Performance Image Quality sessiossa anisses a aasia 26 Axial Measurement Accur sy 2 26 Basic Operational Tests ria 25 Battery CO Aa 28 A A A are 27 eu E S E E 27 Image Quality Verification rrt tit enter Dep 28 Lateral Measurement ACCUTACY nn ae 27 OVerVie Ww aree ER EIERN ere 25 Penetration aii NOESEN EN EENS 27 Bel e 28 Video e DT id 28 Periodic Maintenance ccocooooncocnnnnnnnnnnnononcnnnnnnnnnnnnnonnnnnnnnnnonnnnononnnnnnnnnnnnnioncnannnnnns 11 Peripherals M PY 7 EE ridad 8 Product Fals ehe 33 37 R Replacement Parts Major
20. he front enclosure Qu A W N Reinstall the Rear Cover as described in Rear Cover Installation on page 14 20 Chapter 4 Replacement Procedures Display Backlight Inverter BLI PCB Replacement Required Parts P09195 Display Backlight Inverter PCB P09199 Backlight Inverter Wire Harness optional Display Backlight Inverter PCB Removal 1 Remove the Rear Cover as described in Rear Cover Removal on page 14 2 Remove the two screws from the Backlight Shield Cover and set the shield aside 3 Disconnect the LCD wire harness connecting the Backlight Inverter PCB and the LCD as shown in Figure 4 9 4 Carefully remove the Backlight Inverter PCB from the enclosure 5 Disconnect the BLI Power Harness from the Backlight Inverter PCB and set aside LCD Wire Harness BLI Power Harness P09199 BLI Shield Cover P09855 BLI Power Harness routed through shield vent holes Figure 4 9 Backlight Inverter Replacment Display Backlight Inverter PCB Installation 1 Reconnect the BLI Power Harness to the replacement Backlight Inverter PCB 2 Reconnect the LCD wire harness to the replacement Backlight Inverter PCB 3 Insert the replacement Backlight Inverter PCB into the on the LCD Housing as shown in Figure 4 9 4 Route the BLI Power Harness through the enclosure vent holes as shown in Figure 4 9 5 Reinstall the Backlight Inverter Shield Cover and two mounting screws Torque the screws to 5 5 inch pounds 62
21. he video output at the video receptacle Test Video Output Optional 1 2 Attach an external video monitor to the video connector using the video cable 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 3 Troubleshooting for troubleshooting procedures Chapter 5 Performance Testing Appendix A Replacement Parts List The following tables contain all the field replaceable parts for the NanoMaxx ultrasound system Quantities are one unless otherwise noted Major System Components Table 1 Major System Components Item Number PartNumber Description 1 P12745 Power Supply PCB Service Assembly Shown without shields Not shown P09866 Shield Digital Bottom Bottom Power Supply Shield Not shown P09867 Shield Digital Top Top Power Supply Shield 2 P12718 Back End PCB Service Assembly 3 P12717 Front End PCB Service Assembly 4 P09196 Fan Cable 5 P13068 Service Assembly NanoMaxx Rear Enclosure Enclosure only does not contain any ofthe parts listed above Appendix A Replacement Parts List 29 Other System Components Table 2 Other System Components Item Number Part Number Description 1 P09200 Display Cable Assy 2 Part of LCD Assembly 3 P09195 Backlight Inverter P
22. i Backlight Invert LCD Touchscreen Cable Backlight Inverter PCB Shield nverter Display Cable User Interface PCB FFC 6 Cable Assy LCD Housing Figure 4 7 Other Major System Components Chapter 4 Replacement Procedures 19 User Interface PCB Replacement Required Parts e P12329 User Interface PCB NanoMaxx User Interface PCB Removal 1 Remove the Rear Cover as described in Rear Cover Removal on page 14 2 Remove the knob from the front of the system 3 Disconnect the LCD touchscreen ribbon cable from the User Interface PCB as shown in Figure 4 8 4 Remove the five screws shown in Figure 4 8 Caution The FFC ribbon cable connector is fragile and will require replacement of the User Interface PCB if damaged 5 Disconnect the FFC ribbon cable by gently lifting up on the connector latch as shown in Figure 4 8 ps LCD Touchscreen ribbon cable cable Figure 4 8 User Interface PCB Replaclement User Interface PCB Installation 1 Reinstall the FFC ribbon cable onto the replacement User Interface PCB as shown in Figure 4 8 Ensure the cable is fully seated into the connector and reengage the connector latch Install the replacement User Interface PCB onto the front enclosure as shown Figure 4 8 Reinstall the five screws and torque the screws to 5 5 inch pounds 62 newton centimeters Reconnect the LCD Touchscreen ribbon cable ensuring the cable is looped as shown in Figure 4 7 Reinstall the knob on t
23. iew Description of Operating Modes 2D Mode Color Doppler Color Color Power Doppler CPD 2D mode is a two dimensional image of the amplitude of the echo signals Itis 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 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 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 color gray scale echo information or a blended combination is based on the relati
24. ignals 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 Chapter 2 System Overview Additional System Feature Performances Broadband Imaging Needle Guidance Measurement and Calculation Capabilities This ultrasound acquisition system uses high resolution broadband technology in the transmit pulsers transducers 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 pulse 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 The system can display a pair of needle guidelines that re
25. ion measurements on a phantom apply the phantom reference value and tolerance to the measurement Some features and capabilities are optional and therefore may be unavailable to test Test Equipment SonoSite ultrasound system under test Transducer compatible with the system under test RMI413A Soft Tissue Phantom RMI 403 GS Multipurpose Phantom or equivalent A referenced 7db cm phantom is required for performing penetration measurements Video printer recommended Acoustic gel Set Up Performance Tests Set Up Performance Tests 1 Attach a compatible transducer to the system under test 2 Select Gen for optimization type 3 Couple the 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 Basic Operational Tests Basic System Operation Tests 1 Verify that the correct transducer name appears in the upper right corner of the system display 2 Verify proper date and time 3 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 4 Verify that all controls and buttons smoothly
26. n Figure 4 11C Be careful not to disengage the cable from the LCD connector as shown in Figure 4 11A 4 Insert the Display Housing with LCD into the front enclosure and loosely install the four mounting screws as shown in Figure 4 10 on page 22 u Check proper routing of cables to prevent damage 6 Observe the position of the LCD from the front of the enclosure and adjust the position as necessary to center the LCD in the opening 7 Tighten the four mounting screws to 5 5 inch pounds 62 newton centimeters Kapton tape B Cable Routing C Cable Routing Figure 4 11 LCD Installation 8 Reconnect the LCD Power Wire Harness and dress the cable as shown in Figure 4 10 on page 22 9 Reinstall the Rear Cover as described in Rear Cover Installation on page 14 Chapter 4 Replacement Procedures 23 24 Chapter 4 Replacement Procedures Chapter 5 Performance Testing Overview WARNING Critical Test Function A failure of the system functions tested in this section could adversely affect the safety or effectiveness of the system 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 RMI 413A Soft Tissue Phantom or the RMI 403 GS Multipurpose Phantom A 7db cm phantom is required for performing penetration measurements Any equivalent 7db cm Phantom is acceptable When making penetrat
27. newton centimeters 6 Reinstall the Rear Cover as described in Rear Cover Installation on page 14 Chapter 4 Replacement Procedures 21 LCD Replacement Required Parts e P09732 LCD 8 4 This part number is for the LCD monitor only Cables and mounting hardware are not included e P09200 Display Wire Harness optional LCD Removal 1 Remove the Rear Cover as described in Rear Cover Removal on page 14 2 Disconnect the LCD Power Wire Harness from the Display Backlight Inverter PCB as shown in Figure 4 10 3 Disconnect the Touchscreen cable from the User Interface PCB as shown in Figure 4 10 4 Remove the four LCD frame mounting screws shown in Figure 4 10 5 Remove the LCD mounting frame from the front enclosure 6 Remove the Display Cable connected to the LCD Disconnect LCD Power Wire Harness Disconnect LCD Touchscreen cable Display Cable P09200 LCD Mounting Screws 4x Figure 4 10 LCD Removal 22 Chapter 4 Replacement Procedures LCD Installation Caution Use extreme caution when installing the Display Cable to prevent irreparable damage to the LCD om Connect the Display Cable to the LCD as shown in Figure 4 11A Apply a piece of Kapton tape to the connector and LCD housing to aid in cable retention 2 Insert the replacement LCD into the Display Housing loosely routing the cables as shown in Figure 4 11B 3 Route the Display Cable under the display housing as shown i
28. od d d with ON OFF g 4 PO o d Swt to GRD Pps On Off i j i Battery t F YS A beer Po od od H i prO od Battery 5 LION ES Charge 74 H versi n H 1 i H Control i Pid i i I oe VPWR 18 433 5 0 33 HV HVBIAS B Pato H ToBEBoad Power Supply i BE 129V 9V BATTERY Figure 2 1 SonoSite High Resolution Ultrasound System NanoMaxx 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 depending on transducer selected 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 echoes 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 information The Display Subsystem converts the detected ultrasound data into pi
29. onosite d Remove P09037 M3 5x6mm screws 10x Figure 4 4 Front End PCB Replacement Front End PCB Installation 1 Reinstall the ten screws shown in Figure 4 4 and torque to 5 5 inch pounds 62 newton centimeters 2 Reinstall the Rear Cover as described in Rear Cover Installation on page 14 16 Chapter 4 Replacement Procedures Power Supply PCB Replacement Required Parts P12745 Service Assembly Power Supply M Turbo NanoMaxx Power Supply PCB Removal 1 Remove the Rear Cover as described in Rear Cover Removal on page 14 2 Remove the upper Power Supply Shield not shown by removing the 4 screws 3 Remove the hex standoffs x4 as shown in Figure 4 5 4 Remove the screw as shown in Figure 4 5 5 Remove the Power Supply PCB z P09037 M3 5x6mm screw P10273 Hex Standoff M3 5x10 4x Figure 4 5 Power Supply PCB Replacement Power Supply PCB Installation 1 Ensure the Lower Power Supply Shield is properly installed under the Power Supply mounting location 2 Place the replacement Power Supply PCB onto the Front End PCB 3 Reinstall the one screw and the four hex standoffs in the locations shown in Figure 4 5 and torque all fasteners to 5 5 inch pounds 62 newton centimeters 4 Reinstall the Upper Power Supply shield and torque the shield fasteners to 5 5 inch pounds 62 newton centimeters Chapter 4 Replacement Procedures 17 Back End PCB Replacement Required Parts P1271
30. orting 33 Service Event Report Form BASonoSite Service Event Report Carrying Ultrasound into the Future Instructions on reverse Parts Status check one g Ne parts necessary for this repair Service Event Report for your information py neea parts for this repair list the parts below and attach Purchase Order O Out of Box Failure For SonoSite Use Only Service Request Work Order O Warranty Service O Out of Warranty Service pj need parts to replenish my stock list the parts used below and attach Purchase Order a Will not replenish stock Please give me a RMA for the return of the faulty parts pj No parts necessary Please issue a RMA for repair at SonoSite Service Provider Name rider References bmpay T bes Y Prem Fees Emaar OOOO Device Description Serial Number Name O EAN 0 ARWSHOBVesen Eemer Problem Found LL Service Performed Pamesa pe 1 SSCS Parts Removed Part Number Serial Number Lot Number Replaced B Parts Installed Part Number Serial Number Lot Number Replaced B Tests Performed attach test data Performed By Performed By Result Pass Fail Result Pass Fail 7 Attach additional sheets as required Page of F00019 Rev E 34 Appendix B Service Event Reporting Service Event Report Instructions Instructions for completing the Service Event
31. over their full range and that the system responds properly 5 Verify that all of the softkeys are functional 6 Verify that as the Gain controls are increased and decreased there is a corresponding increase and decrease in echo intensity Chapter 5 Performance Testing 25 2D Performance Tests 2D Performance Image Quality Test 2D Performance and Image Quality 1 6 Adjust the position of the transducer on the phantom to acquire a good phantom image as described in the Set Up Performance Tests section 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 Axial Measurement Accuracy Note Measurements must be performed while the image is frozen 26 Set Up Axial Measurement Accuracy 1 2 3 Acquire a phantom image of the target pins as described above Press the Freeze key Press the Calipers key The caliper ap
32. pears See the NanoMaxx Ultrasound System User Guide if necessary for caliper operation Use the Knob and Up Down Left Right buttons to position the first end of the caliper Press the Select button to enable the other end of the caliper Use the Knob and Up Down Left Right buttons to position the second end of the caliper The results update as you move the caliper and the measurement is complete when you finish moving the calipers Test Axial Measurement Accuracy 1 2 Measure the distance center to center of any two pins that are 5 12 cm apart vertically Verify that the distance measured is within the tolerance listed in Table 1 on page 27 Chapter 5 Performance Testing Lateral Measurement Accuracy Set Up Lateral Measurement Accuracy Perform Set Up Axial Measurement Accuracy on page 26 Test Lateral Measurement Accuracy 1 2 3 Measure the distance center to center of any two pins that are 4 10 cm apart horizontally Verify that the distance measured is within the tolerance listed in Table 1 Press the Freeze key to return the system to live 2D mode Table 1 System Measurement Accuracy Measurements Tolerance Axial Distance 2 Lateral Distance 2 Penetration TBD Additional Performance Tests Color Doppler Color Test Color 1 2 on A Un A Connect any transducer Press the Color key A Region of Interest ROI box is displayed on top of the grayscale image Use the touchs
33. present the anticipated path of the needle The image of the anatomical target needle guidelines and a scan plane marker are displayed to assist in guiding the needle to the target For additional information see the needle 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 System Specifications This section contains system and accessory specifications and agency approvals The specifications for recommended peripherals can be found in the manufacturers instructions See the applicable SonoSite accessory user guide for information on the accessories System Dimensions Height 8 2in 20 8 cm Width 14 1 in 35 8 cm Depth 2 3in 5 8 cm Weight 6 lbs 2 72 kg Display Dimensions Length 8 4 in 21 34 cm Height 6 3 in 16 cm Diagonal 10 4 in 26 4 cm Transducers Note Each of the NanoMaxx system types S ICU S Nerve etc supports a unique combination of transducers C11n 8 5 MHz 11 mm curved array 6 ft 1 8 m C60n 5 2 MHz 60 mm curved array 5 5 ft 1 7 m L25n 13 6 MHz 25 mm linear array 7 5 ft 2 3 m L38n 10 5 MHz 38 mm linear array 5 5 ft 1 7 m P21n 5 1 MHz 21 mm phased array 6 ft 1 8 m 6 Chapter 2 System Overview Imaging Modes 2D 256 gray shades Color power Doppler CPD 256 colors Color Doppler Color 256 colors
34. rol Panel TBA System Repair The system is repairable through subassembly replacement or through replacement of parts as recommended by SonoSite in Chapter 4 Replacement Procedures 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 3 Troubleshooting 11 Failure Assert Codes Assert or Assert Code are software error codes that are generated by all Sonosite products when certain hardware or software fault conditions exist Providing the Assert Code to the Technical Support Group may assist in quicker and more accurate fault diagnosis Hardware Assert Codes typically cannot be reset and will usually require Main PCB replacement Many software Assert Codes can be reset and the system may recover and operate normally usually requiring a reboot Handling Assert Codes 1 Record the Assert Code The Assert Code is a four or five digit number shown on the C line of the Maintenance Screen A typical Maintenance Screen with an Assert Code is shown in Figure 3 1 O BSonoSite nanomaxx P EXCEPTION_ACCESS VIOLATION 14427 Cc D RO 0x40D40000 R1 0x40D3FFF8 R2 OxFFFFFFFF R3 0x00000000 R4 0x40D3FE78 R5 0x
35. ve 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 In CPD 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 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 s
36. vice identification label ARM 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 A description 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 if 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 35 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 Shippin
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