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MicroMaxx Ultrasound System Service Manual

1. Control Panel sasirik tikia Replacement Parts System sscssssssecssecssscsssecssecsssceseeeseeseeesees Transducer Nest Frame Assembly Ordering Replacement Parts sss Appendix B Service Event Report vi E Sono ite Chapter 1 Introduction Before servicing the MicroMaxx ultrasound system please read the information in this manual This text applies only to the SonoSite MicroMaxx ultrasound system product manufactured after June 1 2005 Please find service information about products manufactured before June 1 2005 in C1 51 Ultrasound System Service Manual PO0715 C1 75 Ultrasound System Service Manual P01118 C1 9 PLUS Ultrasound System Service Manual P02287 C1 99 PLUS and ELITE Ultrasound System Service Manual P02913 and TITAN Ultrasound System Service Manual P03309 Audience The intended audience of this manual is properly trained field and in house service personnel Conventions Used in This Service Manual These conventions are used in this service manual AWARNING describes precautions necessary to prevent injury or loss of life A Caution describes precautions necessary to protect the products When the steps in the operating instructions must be performed in a specific order the steps are numbered Bulleted lists present information in list format but they do not imply a sequence The system handle is on the front of the system and the battery comp
2. Delete OB Custom Tables 1 Pressthe Setup key 2 Select OB Custom Meas or OB Calculations 3 Select Tables from the on screen menu 4 Selectthe desired custom OB table 5 Select Delete from the on screen menu to remove the custom table from the system Presets Presets Doppler Scale cm s Duplex 1 3 2D 2 3 Trace Live Trace Peak Thermal index TS A Save Key image Only Dynamic Range 0 MT Figure 18 Setup Screen Presets Doppler Scale Press the Setup key Select Presets In the Doppler Scale list select cm s or kHz UJ N Duplex Press the Setup key 2 Select Presets 3 Inthe Duplex list select desired image display Full 2D Full Trace 1 3 2D 2 3 Trace 1 22D 1 2 Trace Live Trace Press the Setup key Select Presets In the Live Trace list select Peak or Mean w N gt e Thermal Index Press the Setup key 2 Select Presets 3 Inthe Thermal Index list select TIS TIB or TIC 36 Chapter 4 Setup and Operation SonoSite Save Key 1 Press the Setup key 2 Select Presets 3 Inthe Save key list select Image Only or Image Calcs to designate the function of the Save key Selecting Image Only allows the Save key to save the image to the CompactFlash card Selecting Image Calcs allows the Save Key to save the image to the CompactFlash card and to save the current calculation to the report Dynamic Range 1 Selectthe desired ex
3. Press the THI key on the control panel so it displays THI on the display Tissue Harmonic Imaging in now active Observe a decrease in dot size and a significant loss in penetration due to the higher frequency Image resolution increases Press the THI key again to turn off Tissue Harmonic Imaging 72 Chapter 8 Performance Testing SonoSite Pulsed Wave PW Doppler Imaging Test PW Doppler Imaging U A UN Attach the C15 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 Gently tap the top of the gel and observe a reflection on the spectral trace and the sound from the speakers Press the 2D key to return to 2D imaging Image Quality Verification Test Livescan Products with replaced subassemblies or products that have been otherwise disassembled must undergo an Image Quality Verification Test Livescan The Image Quality Verification Test Livescan should be performed after successfully completing Setting Up Performance Tests on page 69 and CPD on page 72 Thetest is completed before returning the system to service Acertified sonographer must perform the test The Livescan test performed is at the discretion of the Sonographer and will represent their acceptance of a successful service event Image Review Review all saved images and verify that the images are displa
4. Transducer 2 Pull the transducer connector away from the system Turning System On Off Caution Do not use the system if an error message appears on the display Note the error code and turn off the system Call SonoSite or your local representative Turn System 1 Locate the Power key on the top left side of the system See Figure 4 1 on page 21 On Off 2 Pressthe Power key once to turn on and once to turn off Wake Up To conserve battery life the system is configured to go into sleep mode The system goes into System sleep mode when the lid is closed or if the system has not been touched for a preset amount of time Press any key touch the touchpad or open the lid to wake up the system To adjustthe time for sleep delay see Sleep Delay on page 28 Chapter 4 Setup and Operation 41 Upgrading the System and Transducer Software 42 As described in About the System Software on page 3 software upgrades are provided on CompactFlash cards which are installed in the back CompactFlash slot on the right hand side of the system Upgrades provided may be required or optional Whenever you install a CompactFlash card containing a newer version of software into the system the system will determine the level of software prepare the system for the upgrade and then install the new software onto the system When a CompactFlash card contains new transducer software and the transducer that requires a software upgrade is connected t
5. LED Burned Out Key Not Working No Gain Control Touchpad Not Responding Replace Control Panel Replace Compression Connector Main PCBA to Control Panel Corrected Yes Corrected Perform Verification Tests for Control Panel Yes Perform Verification Tests for Control Panel Figure 6 3 Control Panel Flow Diagram Replace Main PCBA Corrected No Contact Yes SonoSite Technical Support Perform Verification Tests for Control Panel Chapter 6 Troubleshooting 55 System MicroMAXX System Has A Power On Failure No Indication Of Power Listen For A Single When You Press The ON Beep Look For A Button Video Display Remove the System from the Docking System and Power On the System with the Battery Install the System in the Docking System with AC Adapter Attached and Power On Again Yes Charge or Repl Replace Pe Battery Adapter Install the System in the Docking System with AC Adapter Attached and Power On Again Yes Yes No Replace Replace Main PCB Main PCB Perform Image Quality Tests In Corrected Yes Ch 8 And Verify AC Power Operation Corrected Contact SonoSite No Technical Support Figure 6 4 System Flow Diagram 56 Chapter 6 Troubleshooting Perform Verification Tests in Chapter 8 Perform Verification Tests in Chapter 8 Perform Image Quality Tests In Ch 8 And
6. Quality with no dropouts or intensity variations 2 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 Axial Measurement Accuracy Note Measurements must be performed while the image is frozen Set up Axial 1 Acquire the image Accuracy 2 Press the Freeze key 3 Press the Caliper key The caliper appears on the image display The screen menu indicates Cal 1 Cal 2 and Ellipse If the caliper line setup is on then a dotted line connects the two calipers See the MicroMaxx Ultrasound System User Guide if necessary The Cal 1 caliper is active by default 4 Use the touchpad to position one of the calipers 5 Press the Select key to fix the caliper and enable the other caliper 6 Usethe touchpad to move the other caliper The results update as you move the caliper and the measurement is complete when you finish moving the calipers Press the Select key to alternate the active caliper and adjust the measurement with the touchpad 7 To perform another distance measurement on the image select the other distance icon and repeat the preceding steps Test Axial 1 M Measure the distance center to center of any two pins that are 5 12 cm apart vertically Accuracy 2 Verify that the distance measured is within the tolerance listed in Table 8 1 70 Chapter 8 Performance Testing SonoSite Lateral
7. touchpad or arrows are selected This icon indicates that system maintenance may be required Record the number in parentheses on the C line and contact SonoSite or your SonoSite representative A maintenance icon displays on the system screen 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 8 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 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 the SonoSite Technical Support department Table 6 2 Troubleshooting Subassemblies and Diagnostic Figures Subassemblies Diagnostic Figures or Table Display Figure 6 2 Control Panel Figure 6 3 System Figure 6 4 Battery Figure 6 5 DICOM Table 6 3 System Repair 52 The system is repairable through subassembly replacement or through replacement of parts as recommended by SonoSite in Chapter
8. 6104126 6113547 6117085 6142946 6203498 B1 6371918 6135961 6364839 6383139 6416475 6447451 6471651 6569101 6575908 6604630 6648826 6835177 D0280762 D0285484 D0286325 D0300241 D0306343 D0328095 D0369307 D0379231 D456509 D461895 10 682699 10 407682 Other patents pending P05324 01 09 2005 Copyright 2005 by SonoSite Inc All rights reserved i BA SonoSite Contents Chapter 1 Introduction Uo T Ta e RE EET 1 Conventions Used in This Service Manual cccsssssessesssessesssessesssesssessesseeseesseess 1 Product Upgrades and Updates e eeeeenteeentttnnnttnnnns 1 Customer COrnmelits sssssisscssssssorosscsssssassenscssisesecosstneessanscecobenssosenssieansansensedesnesoseasauonsees 1 ADOUE TMS SY Ars 2 About the System Software ou ssssssssssecssssccsssecsssesccsseecssesessseccsseecsuseccsseescusesessseesasees 3 Software Licensing oeesssessssssscsssscssssccsssscssusccsssscssusccsssecssusccssuccssuscssssecssuccesaseessuscessueesssses 3 Chapter 2 Safety Electrical Safety Equipment Safety Battery Safety m Biol gical SATE LY o MH 8 Labeling SYMDOlS eee 8 Chapter 3 System Overview rS 9 Theory of Opetation sisiscsiscsscscsssscsssiossseiesettuucssssscecnsssaseccunaasaesstesseesbehecensisbontascnnasnsasss 10 Description of Operating Modes sl Velocity Color Dopp
9. Continued Number System Control Description 7 Near Adjusts the gain applied to the near field of the image Far Adjusts the gain applied to the far field of the image Gain Adjusts the overall gain applied to the entire image 8 AC power A steady green light indicates AC power is connected A flashing green light indicator indicates the system is in sleep mode 9 Caliper Calcs Caliper activates a measurement caliper on the screen Calcs turns the calculation menu on and off 10 Touchpad Use to select adjust and move objects on the screen 11 Select Use to switch between frozen images in duplex and dual screens color and Doppler menus calipers for measurement calipers pictograph marker position angle picto arrow position orientation arrow 12 Print Prints the active image to the printer 13 Save Saves an image to the CompactFlash card Saves an image to the CompactFlash card and saves measurements calculation to the report when configured in system setup 14 Remappable Controls features on the context menu which are adjusted based on the system controls state 15 Forms Setup Access to the system settings Report Access to the patient report Review Access to the patient list and saved patient images and archive functions Patient Access to patient information 16 A Delta key Use as a shortcut to existing functionality in the system 17 Save clip Saves a clip to the CompactFlash card Record Turns DVD VCR record on
10. External monitor does not work Check all power connections Perform the following sequence remove DC input connector and battery wait 10 seconds connect DC input or install battery press the power key Ensure the battery is charged Adjust the LCD screen to improve viewing angle Adjust the brightness as necessary to improve image quality Adjust the gain Adjust the gain Adjust the gain or the scale Select the OB exam type Set the correct printer in system setup Check the printer connections Check the printer to ensure that it is turned on and set up properly See the printer manufacturer s instructions if necessary Check the DVD VCR connections Check the DVD VCR to ensure that it is turned on and set up properly See applicable SonoSite accessory user guide and the manufacturers instructions if necessary Check the monitor connections Check the monitor to ensure that it is turned on and set up properly See the monitor manufacturers instructions if necessary Chapter 6 Troubleshooting 51 Table 6 1 Troubleshooting Continued Symptom Solution Unexpected labels using the Ensure labels have been assigned to the function keys function keys Inaccurate fetal age calculation Ensure that the patient information date and time are set accurately System does not recognize the Disconnect and reconnect the transducer transducer Text cursor does not move when Text cursor is constrained to one line
11. FTA FL 5 additional custom Growth Analysis Table Measurements WARNING measurement labels BPD HC AC FL EFW Prior to use verify custom table data entries are correct The system does not confirm the accuracy of the custom table data entered by the user View OB Tables A0 Press the Setup key Select OB Custom Meas or OB Calculations Select Tables from the on screen menu Select the desired table Age or Growth and measurement author Create New OB Custom Tables Oo O NOAUA UN Press the Setup key Select OB Custom Meas or OB Calculations Select Tables from the on screen menu Select the desired table Age or Growth In the measurement list select the desired measurement for the custom table Select New from the on screen menu In the Author field enter a unique name Enter the data Select Save from the on screen menu Two custom tables may be created for each OB measurement Note To display the measurement for the custom table in the calculation menu see OB Calculations Authors on page 33 and select More Note Growth analysis tables cannot be created for custom OB measurements Chapter 4 Setup and Operation 35 Edit OB Custom Tables 1 Press the Setup key 2 Select OB Custom Meas or OB Calculations 3 Select Tables from the on screen menu 4 Select the desired custom OB table 5 Select Edit and enter data and then select Save from the on screen menu
12. Name of the person installing the upgrade Name of the person installing the upgrade Serial number located on the bottom of your system Serial number ARM version REF number PCBA serial number SH database version Installing a License Key When you have obtained a license key for your software you must enter it into the system Once a valid license key has been entered the system remains licensed until the next time the system software is upgraded Install 1 Turnon the system License Key If the software is not yet licensed the license update screen displays The license update screen displays the following information how to contact SonoSite the required information to obtain the license key and the grace period time remaining on your system s a OO5MayO3 10 12 Please enter a new license key or cancel System Please enter a new license key or cancel Transducer this operation this operation To obtain a license key To obtain a license key 1 Contact SonoSite at 1 877 667 8118 1 Contact SonoSite at 1 877 657 8118 WWw sonosite com www sonosite com service sonosite com service sonosite com 2 Supply the following a Your name 2 Supply the following a Your name b System serial b Transducer part ARM version Transducer bundle version 30 40 300 019 20 80 200 001 E d PCBA serial d Transducer serial 000000 033K59 e Previous license update 161428413005 3 Enter license key Bri cs 3 Enter license key rm E
13. OK Cancel Figure 8 User Login and Change Password Note User Login is displayed when system access is turned on User Login In User Login enter Name and Password and click OK Guest Login In User Login select Guest In Guest mode the user is able to scan but is restricted from accessing system setup and patient information Change 1 In User Login select Password Password 2 Enter your old password new password confirm the new password and then click OK To ensure passwords are secure it is recommended that passwords contain characters from the following categories Upper case characters A Z Lower case characters a z Numbers 0 9 Note The password is case sensitive Chapter 4 Setup and Operation 27 Audio and Battery Audio Key click On Beep alert On d Battery and Power Steep delay min 10 Power delay min Off ENNE 3 3 NEM Figure 9 Setup Screen Audio Battery Key Click 1 Press the Setup key 2 Select Audio Battery 3 Inthe Key click list select On or Off Beep Alert 1 Press the Setup key 2 Select Audio Battery 3 Inthe Beep alert list select On or Off Sleep Delay 1 Press the Setup key 2 Select Audio Battery 3 In the Sleep delay list select Off 5 or 10 minutes Power Delay 1 Press the Setup key 2 Select Audio Battery 3 In the Power delay list select Off 15 or 30 minutes Reset Select Reset from the on screen menu to re
14. Wall filter Resampler Hilbert phase shifter stereo separator Audio output Fast Fourier transformer FFT Magnitude estimation Temporal averaging Compression Wall Filter Resampler Hilbert Phase Shifter and Audio Output Fast Fourier Transformer The wall filter is a high pass filter used to remove the clutter velocity information or wall motion signal Time domain Doppler samples are transformed into spectral lines using a fast Fourier transform FFT technique The resampler module does the selection of a sample set used for computing windowed FFTs It thus interfaces the processing thread operating at the PRF rate with the one that computes FFT on segments of data separated at the FFT rate The gain adjusted IQ stream from the wall filter is processed by a Hilbert Transformer to shift an in phase component by 90 degrees to present the Doppler signal as stereo audio The 90 degree phase shift in the in phase component is accomplished by convolving it with the Hilbert Transform impulse response The quadrature component data stream does not undergo any filtering other than a delay that matches the group delay of the in phase channel This is followed by a stage that computes the sum and difference of in phase and quadrature components to produce stereo audio data This module applies a window function to the IO sample set selected for spectral estimation followed by the FFT Radix 2 decimation in time FFT is performed usin
15. housing and cable Do not use the transducer if the transducer or cable is damaged To avoid the risk of electrical shock always disconnect the power supply from the system before cleaning the system To avoid the risk of electrical shock do not use any transducer that has been immersed beyond the specified cleaning or disinfection level See the MicroMaxx Ultrasound System User Guide To avoid the risk of electrical shock and fire hazard inspect the power supply AC power cord and plug on a regular basis Ensure they are not damaged To avoid the risk of electrical shock use only accessories and peripherals recommended by SonoSite including the power supply Connection of accessories and peripherals not recommended by SonoSite could result in electrical shock Contact SonoSite or your local representative for a list of accessories and peripherals available from or recommend by SonoSite To avoid the risk of electrical shock use commercial grade peripherals recommended by SonoSite on battery power only Do not connect these products to AC mains power when using the system to scan or diagnose a patient subject Contact SonoSite or your local representative for a list of the commercial grade peripherals available from or recommended by SonoSite Chapter 2 Safety 5 WARNING Caution To avoid the risk of electrical shock inspect cables and power cords used within the system on a regular basis for damage To avoid the risk of
16. M PW THI CW Color DICOM P S MWL DPLX EOBC IMT Figure 4 15 System Information Screen To Display the License Update Screen DisplayLicense 1 Press the Setup key Update Screen 2 Select System Information from the on screen menu 3 On the lower section of system information screen select the button under License The license update screen displays 4 Perform the steps in Installing a License Key on page 47 Please enter a new license key or cancel System this operation To obtain a license key 1 Contact SonoSite at 1 877 657 8118 www sonosite com service sonosite com 2 Supply the following a Your name b System serial c ARM version 30 40 300 019 E d PCBA serial 900000 e Previous license update 161428413005 3 Enter license key Figure 4 16 Setup Screen License Key 48 Chapter 4 Setup and Operation SonoSite Chapter 5 Cleaning and Disinfecting Universal Precautions SonoSite recommends that personnel who have regular exposure to medical devices returned for service practice universal precautions Universal precautions are an approach to infection control Those servicing this product should follow the prescribed standards for their area Receipt of Suspected Contaminated Materials SonoSite recommends that personnel who have regular exposure to medical devices returned for service practice universal precautions Universal precautions are an approach to infection control Those servicing
17. Mode list select DICOM or SiteLink After changing connectivity a dialog box is displayed to restart the system Note The settings for SiteLink Image Manager and system configurations must correspond See the SiteLink Image Manger 3 0 User Guide Ethernet Connectivity 1 Press the Setup key 2 3 Select Connectivity In the Transfer Mode list select SiteLink After changing connectivity a dialog box is displayed to restart the system Chapter 4 Setup and Operation 29 Ethernet Setup AUN 5 6 Press the Setup key Select Connectivity Select Ethernet Setup Enter information in the following fields see DICOM chapter for definition of terms HostName IP Address Subnet Mask Default Gateway Alternate Gateway In the Network Speed list select from the list Select Save Reset Select Reset from the on screen menu to return settings for this setup page to factory default Date and Time 4 2005Apr22 13 48 Setup Pages Date and Time Date 2005 1 04 1 22 YYYY MM DD Time 13 hr 48 min Figure 11 Setup Screen Date and Time WARNING An accurate date and time are critical for accurate obstetrics calculations Verify that the date and time are accurate before each use of the system The system does not automatically adjust for daylight savings time changes Date 1 Press the Setup key 2 Select Date and Time 3 In the Date field enter the current date year month and day T
18. SonoSite products can be found in the user guide for each product 8 Chapter 2 Safety SonoSite Chapter 3 System Overview System Overview The SonoSite High Resolution Ultrasound System MicroMaxx is a full featured general purpose software controlled diagnostic ultrasound system 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 and Velocity Color Doppler or in a combination of these modes The System has an electrocardiography ECG display feature and supports a 3 lead ECG cable assembly to collect data for M mode and Doppler measurements The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes The System has a PW and CW Doppler audio output feature and cine review image zoom labeling biopsy measurements and calculations image storage and review printing and recording capabilities The system includes the ability to measure the intima media thickness IMT of the carotid artery using digital ultrasound images The IMT measurement of the carotid artery may be used adjunctively with other medical data obtained by a physician to help assess the cardiovascular health of a patient The system includes Digital Imaging and Communications DICOM capabilities as well as general computer communication capabilities to provide the accepta
19. Support when ordering this part to have the label printed and placed on the part 5 P05472 Service Assembly Main PCBA MicroMaxx 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 6 P00361 Foot 78 Appendix A Parts List SonoSite LJ LL il i E t 3 Ha A S o mm hs p poppe Figure A 1 Power Supply P05471 Figure A 2 Speaker Assembly P03872 Appendix A Parts List 79 80 Figure A 3 TGC Assembly P05470 Table A 4 TGC Assembly Find Number Part Number 1 P02317 2 P04994 3 P02308 Appendix A Parts List Description Assembly PCB TGC Knob TGC FFC 12 Position Jumper BSonoSite Figure A 4 Upper Enclosure P05474 top view Figure A 5 Upper Enclosure Assembly P05474 bottom view Appendix A Parts List 81 Figure A 6 Lower Enclosure P03874 bottom view Figure A 7 Lower Enclosure P03874 top view 82 Appendix A Parts List SonoSite Figure A 8 Main PCB Assembly P05472 Appendix A Parts List 83 Transducer Nest Frame Assembly 1 x8 8 x4 2 x4 4 x4 6 x2 Figure A 9 Nest Frame Parts Table A 5 Nest Frame Assembly Find Number Part Number Description 1 P00364 Connector Interposer 2 P00524 Screw Shoulder Thrust Plate 3 P00353 Wear Plate 4 P00646 Spring Thrust Plate 047 wire 5 P02860 Nest Plate Interpos
20. and Control Panel Removal on page 62 2 Remove the additional 4 screws from the bottom of the system per Figure 7 6 Chapter 7 Replacement Procedures 63 am rose De Oey LLLI own Went Screws 4 Figure 7 6 Bottom Screws 3 Turnthe system over and remove the top enclosure from the main PCBA This exposes all of the replaceable parts for the main system per Figure 7 7 Main PCBA Nest frame assembly Power supply TGC assembly Speaker Speaker Figure 7 7 System Components 64 Chapter 7 Replacement Procedures SonoSite Speaker Replacement Speaker 1 Press on the connector release and pull the connector out of the receptacle Replacement Gently pry off the retaining clip with a flat bladed pry tool See Figure 7 8 Connector Retaining clip Figure 7 8 Speaker Replacement Power Supply Power Supply 1 Gently pry the shield from the power supply and set it aside This part will be used in reassembly Note that the shield fits only one way See Figure 7 9 Power supply shield Figure 7 9 Power Supply Shield 2 Remove the 7 screws that hold down the power supply PCB per Figure 7 10 3 Gently lift the power supply and shield assembly away from the Main PCBA Chapter 7 Replacement Procedures 65 Screws 7 Figure 7 10 Power Supply Screws 66 Chapter 7 Replacement Procedures SonoSite TGC PCBA TGC PCBA 1 Remove the TGC knobs identified in Figure 7 11 TGC kn
21. and off 18 Freeze Stops the live imaging and displays a frozen image Cine Review images stored in the cine buffer back forward through last in first out back forward sequence All mode images can be stored and reviewed in the cine buffer 19 Update Toggles between dual and duplex screens and image modes in M Mode and Doppler e g between 2D Doppler sample line and Doppler spectral trace 22 Chapter 4 Setup and Operation SonoSite Table 4 1 System Controls Continued Number System Control Description 20 Modes M Mode Doppler Color 2D System Components Turns M Mode on and toggles between M Mode sample line and the M Mode trace Turns Doppler on and toggles between Doppler sample line and the Doppler trace Turns CPD Color on and off Turns 2D on The SonoSite system components are identified in About the System on page 2 Setup System setup is used to customize the system Press the Setup key to access and set up the following system functions Administration Audio Battery Connectivity Date and Time Delta Key F Keys Display Information IMT calculations OB Calculations OB Custom Measurements Presets System Information Configure system to protect patient data by requiring users to log on and enter passwords Configure for type of Audio alert Sleep delay and Power delay Configure Printer Video mode Serial Port and Transfer Mode DICOM or SiteLink DICOM a
22. on the receive side the transducer receive echoes are continuously amplified focused about the focal region and converted to a base band quadrature signal The signal is analyzed by a quadrature phase detector that establishes two receive channels to allow detection of flow direction These two channels are then analyzed by a fast complex Fourier transform FFT circuit to establish the spectrum of frequencies present in the echoes The data are displayed as spectrum frequencies with respect to time CW can be used alone but is normally used in conjunction with a 2D image for spatial reference The 2D image has a graphical line D line superimposed on the 2D image indicating where the M mode beam is located 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 PW Doppler mode provides the clinician with the ability to obtain blood flow velocities about a spatial sample volume A burst of ultrasound with a known spectrum is transmitted by the System on the receive side the transducer receive echoes are amplified and range gated at the appropriate depth The signal is analyzed by a quadrature phase detector that establishes
23. quality verification test 73 review 73 import user account 26 L license key install 47 obtain 46 license update screen display 48 live trace 36 login 24 27 M main PCBA failures 53 replacement procedure 63 modes 23 monitor 17 moving image 72 Index 89 90 O OB table set up 35 P password 24 25 27 PC setup 29 performance tests 2D 70 battery 73 CPD 72 M mode 72 overview 69 printer 73 PW 73 THI 72 video output 74 peripherals 19 phantoms RMI 1425A Doppler 69 RMI 403 GS Multipurpose 69 RMI 413A Soft Tissue 69 RMI 425 Doppler 69 power 21 battery charge indicators 40 power supply replacement procedure 65 print image 22 printer problem 51 test 73 printer setup 29 product failures reporting 85 products returning 74 R recording problem 51 remappable controls 22 replacement parts list 75 ordering 84 return material authorization number RMA 74 S safety electrical 5 equipment 6 save image 22 security setup 24 select 22 serial port 29 service event report 85 shipping instructions 74 SiteLink connectivity 29 software license 3 46 upgrade 42 SonoSite technical support contact 74 speaker replacement 65 Index subassembly replacement 52 system charging requirements 40 dimensions 17 information screen 48 measurement accuracy 71 overview 9 software 3 specifications 17 19 troubleshooting diagram 56 turn on off 41 upgrade software 42 wake up 41 system control A
24. system to a PC using a USB Ethernet connection or CompactFlash card Images and clips on the CompactFlash card cannot be viewed directly from a CompactFlash reader Install 1 Verify the ejector pin is fully pushed in CompactFlash 2 Insert the CompactFlash card into the front slot on the ultrasound system See Figure 1 1 on Card page 2 The front slot is used to store images e The back slot is used to update systems transducers and to import export DICOM configuration information and OB Tables The CompactFlash card is ready to use when the save icon and the image and clip counters are displayed on the screen Caution If the CompactFlash icon and image and clip counters are not displayed in the system status the CompactFlash card may be defective Turn the system off and replace the CompactFlash card The CompactFlash card may be restored if it is formatted on a PC Formatting the card will erase all data If the card is physically damaged formatting will not restore it WARNING To prevent loss of data e g images clips or damage to the CompactFlash card always turn the ultrasound system off before removing the CompactFlash card Remove 1 Turn off the ultrasound system before removing the card CompactFlash 2 Press the ejector pin in the front card slot to position it to the outside of the system See Card Figure 1 1 on page 2 3 Press in the ejector pin to eject the CompactFlash card 4 Remove the card 5 Pushin
25. the ejector pin to avoid damaging the ejector pin Chapter 4 Setup and Operation 39 Using AC Power Charging Battery The battery charges when the system is connected to the AC power supply If the system is off or in the sleep state display off a completely discharged battery will fully charge in 2 5 to 3 5 hours If the system is on and in the freeze state a completely discharged battery will fully charge in 5 to 6 hours If the system is in the imaging state the battery is trickle charged at a very low rate and would take several days to fully charge Note To minimize recharging time turn the system off The system can run on AC power and charge the battery in three ways Connected directly to the system Connected to the mini dock See the Mini Dock User Guide Connected to the MDS See the MDS User Guide or MDS Lite User Guide WARNING The equipment shall be connected to a center tapped single phase supply circuit when users in the United States connect the equipment to a 240V supply system Caution Verify the hospital supply voltage corresponds to the power supply voltage range See Electrical on page 19 Operate 1 Connect the DC power cable from the power supply to the connector on the system See System Using Figure 1 2 on page 2 AC power 2 Connect the AC power cord to the power supply and connect to a hospital grade electrical outlet Battery Charge Indicators The Battery Charge Indicator a battery icon located o
26. 04 13 57 User User3 deleted 2008 06 04 13 57 User Usert modified Only the most recent 200 entries are shown above Older entries are automatically deleted a HESSEN DENEN Figure 7 Event Log Event Log 1 Press the Setup key Select Administration 3 Select Log from the on screen menu The Event Log is displayed 4 Select Back to return to the previous menu 26 Chapter 4 Setup and Operation SonoSite Export Event Log Note The Event log and the DICOM network log have the same filename log txt When you export either one to the same CompactFlash card it will overwrite the existing log txt file 1 Insert the CompactFlash card in the back slot of the system 2 Select Log and then Export from the on screen menu 3 View the files on a CompactFlash reader The log is a text file that can be opened by a text file application e g Microsoft Word or Notepad The log file is named log txt Clear Event Log 1 Select Clear from the on screen menu 2 Select Yes to delete or No to cancel Login to System as User Change Password Please enter your old password new password User L confirm the new password and then click OK ogin Passwords must be 6 12 characters and are Please enter your user name and password case sensitive then click OK Clicking Guest allows you to scan but will block access to patient information Name Usero Name Useri Password 1 Oid Password NewPasswrd OK Guest Password kr
27. 4 in 21 34 cm Height 6 3 in 16 cm Diagonal 10 4 in 26 4 cm Transducers C60e 5 2 MHz 60 mm curved array 5 ft 1 5 m HFL38 13 6 MHz 25 mm linear array 5 5 ft 1 7 m ICT 8 5 MHz 11 mm intracavitary array 5 ft 1 5 m L38e 10 5 MHz 38 mm linear array 5 5 ft 1 7 m P17 5 1 MHz 17 mm phased array 6 ft 1 8 m TEE 8 3 MHz phased array 11 15 ft 3 4 m Chapter 3 System Overview 17 Imaging Modes 2D 256 gray shades Color power Doppler CPD 256 colors Color Doppler Color 256 colors M Mode Pulsed wave PW Doppler Continuous Wave CW Doppler Tissue Harmonic Imaging Image Storage The number of images saved to the CompactFlash card vary depending on the card storage capacity Cine buffer Accessories Hardware Software and Documentation AIUM Ultrasound Medical Safety Guidance Document Battery Biopsy Guide Carry case External display Guidance on the interpretation of Tl and MI to be used to inform the operator Annex HH BS EN 60601 2 37 Mobile Docking System Lite MDS Lite Mobile Docking System MDS Mini Dock Power supply Quick Reference Guide SiteLink Image Manager 3 0 SonoCalc IMT System User Guide Triple Transducer Connect Ultrasound gel Cables See the MicroMaxx Ultrasound System User Guide MDS User Guide and the MDS Lite User Guide for information on cables 18 Chapter 3 System Overview SonoSite Peripherals See the manufacturer s specifications for the follow
28. 7 Replacement Procedures of this manual 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 Chapter 6 Troubleshooting SonoSite Test Equipment Test equipment is not required for this troubleshooting section Troubleshooting test aids include an external monitor and a spare battery 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 should display note the assert code and contact SonoSite technical support to clarify the failure Figure 6 1 shows an assert screen as displayed on the system display The assert code is the bracketed number on the line labeled C Follow the System Flow Diagram Figure 6 4 to evaluate the cause of failure ess abort exception Assert code R 8 0x7e9a64 0x7eb570 R 9 0x0 Ox7eb2dc R10 0x0 0x4 R11 0x0 Oxfc77d4 R12 Oxcebid8 0x0 R13 Oxfc776c 0x0 R14 Oxfffffff8 0x0 R15 Oxfffffff8 Figure 6 1 Assert Screen Verifying a System Assert Code System asserts are caused by hardware and or software faults Hardware asserts typically require main PCBA replacement Software asserts can be reset and the system may recover A simple method to identify the cause of the ass
29. C power indicator 22 alphanumeric 21 annotation 21 caliper calcs 22 depth 21 forms 22 freeze 22 gain 22 modes 23 power 21 print 22 remappable controls 22 save 22 select 22 THI 21 touchpad 22 update 22 video recording 22 zoom 21 system setup beep alert 28 date 30 delta key 31 description 23 Doppler scale 36 duplex images 36 export OB tables 33 F keys 31 gestational age 33 growth analysis 33 import OB tables 33 key click 28 live trace 36 mode data 31 OB custom measurement 34 patient header 31 power delay 28 printer 29 save key 37 security 24 serial port 29 sleep delay 28 system information 37 system status 32 thermal index 36 time 30 transfer mode 29 video mode 29 E Sono ite 7 technical support contact 74 text entry problems 52 THI description 21 time 30 touchpad 22 transducer connect 41 problems 52 remove 41 specifications 17 19 storage and shipping 19 upgrade software 42 U update 22 upgrade system software 42 upgrade transducer software 42 user account 26 user login 25 V VCR problem 51 VCR setup 29 video output tests 74 video recording 22 WwW warnings 5 Z zoom description 21 Index 91 92 Index E Sono ite P05324 01
30. Measurement Accuracy Setup Lateral Perform steps 1 through 7 in Axial Measurement Accuracy on page 70 Measurement Accuracy Test Lateral 1 Measure the distance center to center of any two pins that are 4 10 cm apart horizontally Measurement 2 Verify that the distance measured is within the tolerance listed in Table 8 1 Accuracy 3 Pressthe Freeze key to return the system to live 2D mode Table 8 1 System Measurement Accuracy Measurements Tolerance Axial Distance 296 Lateral Distance t 296 Penetration Test 1 Adjust the system controls to obtain a clear image that shows the limits of echo penetration Penetration as shown in Table 8 2 2 Measure from the center of the skinline to the deepest vertical position where the scatter echoes start to break up and tissue definition is lost Table 8 2 Imaging Performance Imaging C60e ICTe P17 L38e HFL38 TEE Performance 2D Penetration 11 5 cm 5 0 cm 19 0 cm 6 0 cm 5 0 cm 18 0 cm Chapter 8 Performance Testing 71 Additional Performance Tests CPD Test CPD Note Use the RMI 425 Doppler Phantom or the RMI 1425A Doppler Phantom 1 Connect any transducer and set up the system for CPD mode 2 Acquire the image 3 Pressand release the Color key for CPD mode Select CPD from the on screen menu A Region of Interest ROI box is displayed on top of the grayscale image Press the 2D key to return to 2D imaging Move CPD Usethe touchpad to move th
31. MicroMaxx Ultrasound System Service Manual E SonoSsite 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 MicroMaxx TITAN and SonoSite TITAN are trademarks of SonoSite Inc Non SonoSite product names may be trademarks or registered trademarks of their respective owners SonoSite products may be covered by one or more of the following U S patents 4454884 4462408 4469106 4474184 4475376 4515017 4534357 4542653 4543960 4552607 4561807 4566035 4567895 4581636 4591355 4603702 4607642 4644795 4670339 4773140 4817618 4883059 4887306 5016641 5050610 5095910 5099847 5123415 5158088 5197477 5207225 5215094 5226420 5226422 5233994 5255682 5275167 5287753 5305756 5353354 5365929 5381795 5386830 5390674 5402793 5 423 220 5438994 5450851 5456257 5471989 5471990 5474073 5476097 5479930 5482045 5482047 5485842 5492134 5517994 5529070 5546946 5555887 5603323 5606972 5617863 5634465 5634466 5636631 5645066 5648942 5669385 5706819 5715823 5718229 5720291 5722412 5752517 5762067 5782769 5800356 5817024 5833613 5846200 5860924 5893363 5916168 5951478 6036643 6102863
32. NNH 71 7 7I NEM MZ NM Figure 4 14 System and Transducer License Screens 2 Enter your license key in the license number field 3 Select Done from the on screen menu to install the license key and license your software Note If you have entered a valid license key and you cannot complete the licensing procedure verify that the license key has been entered correctly The license key should be exactly 12 digits for example 123348990552 with no other characters or punctuation Note If after confirming correct entry of the license key you are still unable to license your system call SonoSite technical support USA Canada customers call 1 877 657 8118 International customers call your local representative or 1 425 951 1330 Chapter 4 Setup and Operation 47 To Display the System Information Screen Display System 1 Press the Setup key Information 2 Select System Information from the on screen menu Screen The system information screen displays the following information Product Modes Previous License Update Boot Version ARM Version DSP Version PCBA Serial Number PLD CPLD Version SH Database Version and SH Serial Number Note The software versions on your system may vary based on your upgrade and configuration 2 2005Apr22 13 57 Boot version 30 40 300 017 ARM version 30 40 300 017 DSP version 30 40 300 09 SH CPLD version 3 1 SH database version 30 40 300 203 SH serial number 033K59 Modes CPD DCPD ECG
33. Name field enter a unique name 5 Inthe Type list select the desired measurement type 6 Select Save The new measurement is displayed in the calculations menu and the OB report Up to five custom measurements may be saved Delete OB Custom 1 Press the Setup key Measurement 2 Select OB Custom Meas 3 Inthe Custom Measurements list highlight the last measurement 4 Select Delete Last Note If associated tables and report data exist for the measurement they will be removed from the system Tables Select Tables from the on screen menu to create Gestational Age tables for a custom OB measurement See OB Custom Tables 34 Chapter 4 Setup and Operation SonoSite OB Custom Tables 2 2005Apr22 13 64 Table G Gestational Age Measurement CRL 116 C Growth Analysis Author Hadiock Range D cm Age Range ddddddadd Addddddads Ro T m Ga FPRECEEEE dididrtd d 2005Apr22 13 55 Table Gestational Age Measurement BPO 1 4 Growth Analysis Author Chitty Figure 17 Setup Screen OB Custom Table Age Table Measurements The system provides gestational age measurements by selected authors for the age table measurements listed in Table 4 2 Growth Analysis Table Measurements The system provides growth graphs or curves for the growth table measurements listed in Table 4 2 Table 4 2 OB Custom Table Measurements Age Table Measurements GS CRL BPD OFD HC TTD AC
34. Setup and Operation 43 Please enter a new license key or cancel System this operation To obtain a license key 1 Contact SonoSite at 1 877 657 8118 www sonosite com service sonosite com 2 Supply the following a Your name b System serial c ARM version 30 40 300 019 R d PCBA serial 000000 e Previous license update 161428413006 3 Enter license key ig Figure 4 8 System Software License Key At this point the software upgrade process is complete but the software is not yet licensed See Obtaining a License Key on page 46 Note If you are upgrading a system and one or more transducers it is recommended to upgrade all items before calling SonoSite Technical Support for your license keys To postpone obtaining a license key press Cancel from the on screen menu Upgrade 1 Transducer 92 Software 3 4 Turn the system off and remove the CompactFlash card from the back slot Connect the transducer for the upgrade Turn the system on Wait approximately 10 seconds and then insert the upgrade CompactFlash card Note XXX identifies the current software version incompatible transducer To use the active transducer please insert the upgrade CF card lt 20 80 201 Xxx gt into the back slot Figure 4 9 Incompatible Transducer Update This screen is not displayed for compatible transducers 44 Chapter 4 Setup and Operation SonoSite Figure 4 10 Upgrade Transducer Software 5 Select Upgrad
35. The Classification for the SonoSite system SiteStand accessories and peripherals when configured together is Group 1 Class A Airborne Equipment Standards RTCA DO160D 1997 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 20 The Health Insurance and Portability and Accountability Act Pub L No 104 191 1996 45 CFR 160 General Administrative Requirements 45 CFR 164 Security and Privacy Chapter 3 System Overview SonoSite Chapter 4 Setup and Operation System Controls Figure 4 1 System Controls Table 4 1 System Controls Number System Control Description 1 2 Power Alphanumeric Annotation Text Picto Arrow THI Depth Depth Up Depth Down Zoom Turns system on and off Use to enter text and numbers Turns the keyboard on and off for text entry Turns the pictographs pictograph marker on and off Displays an arrow that can be moved and rotated within the image area Turns Tissue Harmonic Imaging on and off Adjusts the imaging depth for 2D Decreases imaging depth Increases imaging depth Magnifies image 2x Chapter 4 Setup and Operation 21 Table 4 1 System Controls
36. Verify AC Power Operation BSonoSite Battery No Power When the On Button is Pressed No Indication of Power When You Press the ON Button Did You Hear A Beep When You Pressed the Power Button Is There A Video Display Perform Verification Tests in Ch 8 First Remove o Battery And Then Connect Yes Battery and AC Power Try Again No Go To Titan System Diagram Perform Verification Tests in Ch 8 Charge or Replace Battery Perform Yes Verification Tests in Ch 8 No Go To MicroMAXX System Diagram Figure 6 5 Battery Flow Diagram Chapter 6 Troubleshooting 57 DICOM Table 6 3 DICOM Troubleshooting Error Message Tiller Error Code Cause Troubleshooting Socket communication failed Archiver transaction failed Printer transaction failed DICOM network communication failed Internal failure detected TSOCKET CONNECT FAILURE TDICARCH OPEN FAILURE TDICPRNT OPEN FAILURE TDNETWORK OPEN FAILURE TDNETWORK READ FAILURE 58 Chapter 6 Troubleshooting Invalid network configuration Wrong port number Application is not running Printer is offline Wrong Capture Type Selected Wrong Image Setting Device does not recognize MicroMaxx rejects association Invalid DICOM Attribute 1 Using Ping verify that the Printer Archiver is connected If Ping fails a Check the devices IP address b Check the MicroMaxx IP address S
37. am type 2 Press the Setup key 3 Select Presets 4 Select the desired dynamic range setting 3 2 1 0 1 2 3 Note Negative numbers show higher contrast images and positive numbers show lower contrast images Reset Select Reset from the on screen menu to return settings for this setup page to factory default System Information d 2005Apr22 13 57 Main FPGA version 2 24 SH CPLD version 3 1 SH database version 30 40 300 203 SH serial number 033K59 Modes CPD DCPD ECG M PW THI CW Color DICOM P S MWL DPLX EOBC IMT Figure 19 Setup Screen System Information Press the Setup key Select System Information from the on screen menu Note To install a license key see Install License Key on page 47 System Information 1 2 Change to Default 1 Settings 2 3 Turn the system off Connect the system to AC power See Operate System Using AC power on page 40 Simultaneously press and release 1 and the Power key The system beeps several times and then the image display appears with all default settings Note Default settings cannot be changed by the user Default settings are set at the factory Chapter 4 Setup and Operation 37 Touchpad The touchpad is used to select adjust and move objects on the screen For example it controls the caliper position CPD Color box position floating cursor and more Note The arrow keys control much of the same functionality as the touchpad Accessories F
38. artment is on the back of the system Product Upgrades and Updates SonoSite may offer software upgrades and new features that may improve system performance Service manual updates explaining the effects of upgrades and new features on system performance will accompany the upgrades Customer Comments Questions and comments are encouraged SonoSite is interested in your feedback regarding the service manual Please call SonoSite at 1 877 657 8118 If you are outside the USA call the nearest SonoSite representative You can also send electronic mail e mail to SonoSite at the following address service sonosite com Chapter 1 Introduction 1 About the System 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 are dependent on your system configuration transducer and exam type Figure 1 1 MicroMaxx System Front View Table 1 1 MicroMaxx System Front Features Number Feature 1 Control panel 2 Handle 3 Display 4 CompactFlash slots front for image storage back for system and transducers updates import export OB tables user names passwords and DICOM configurations Figure 1 2 MicroMaxx System Rear View Table 1 2 MicroMaxx System Rear Connectors Number Feature 1 DC input connector 2 I O connector 3 Battery 4 ECG connector 2 Chapter 1 Introduction SonoSite The system is a portabl
39. as the heart is displayed in real time Ultrasound echoes of different intensities are mapped to different gray scale or color values in the display The outline of the 2D cross section may be a rectangle parallelogram trapezoid sector or a full circle depending on the particular transducer used 2D mode can be used in combination with any other modes M Mode M Mode is also known as T M mode or time motion mode It is used primarily for cardiac measurements such as valve timing and septal wall thickness when accurate timing information is required Ultrasound echoes of different intensities are mapped to different gray scale values in a scrolling display M Mode displays time motion information of the ultrasound data derived from a stationary beam Depth is arranged along the vertical axis with time along the horizontal axis M Mode can be used alone but is normally used in conjunction with a 2D image for spatial reference The 2D image has a graphical line M line superimposed on the 2D image indicating where the M Mode beam is located Color Power In CPD a real time two dimensional cross section of blood flow is displayed The 2D Doppler cross section may be presented as a rectangle parallelogram trapezoid sector or a full CPD circle depending on the particular transducer used The 2D cross section is presented as a full color display with various colors being used to represent the power in blood flow echoes Often to provide s
40. cale 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 In this feature parameters for signal and image processing are optimized to maximize the image quality or to obtain the best compromise of resolution and penetration for different specific clinical applications These parameters include the order of received filters the bandwidth the dynamic range the compression curve the gain setting and parameters for compounding frequency band etc For example different system parameter setups are used for abdominal or peritoneal scanning This feature is for ease of use for the operator by automatically setting up system control parameters rather than manually adjusting settings for best performance The System is capable of displaying a pair of biopsy guidelines that represent the anticipated path of the biopsy needle The image of an anatomical target biopsy guidelines a scan plane marker and a biopsy needle are displayed on the monitor to assist in guiding the biopsy needle to the target The system als
41. e 2D echo For each pixel in the overlay the decision of whether to display VCD gray scale echo information or a blended combination is based on the relative strength of echoes from the soft tissue structures and from the red blood cells A high pass filter wall filter is used to remove the signals from stationary or slowly moving structures Tissue motion is discriminated from blood flow by assuming that blood is moving faster than the surrounding tissue although additional parameters may also be used to enhance the discrimination The remaining signal after wall filtering may be averaged over time persistence to present a steady state image of blood flow distribution Variance information may also be displayed to provide information when large variance is observed in the velocity information Chapter 3 System Overview SonoSite Broadband Imaging Tissue Specific Imaging Biopsy Guidance Measurement and Calculation Capabilities Continuous Wave Doppler Audio Output Pulsed Wave Doppler Audio Output Electrocardiograph ECG Display Additional System Feature Performances This ultrasound acquisition system uses high resolution uses broadband technology in the transmit pulsers transducer and receivers The receive path can capture and process signals over a wide spectrum from below 2 0 MHz to beyond 10 MHz For each application the transmit pulse is designed to produce an appropriate bandwidth For example in 2D grays
42. e software controlled ultrasound system using all digital architecture The system is used to acquire and display high resolution real time ultrasound images 2D color power Doppler CPD Color Doppler Color Tissue Harmonic Imaging THI M Mode pulsed wave PW Doppler and continuous wave CW Doppler The system has a cine buffer pan zoom labeling biopsy measurements calculations a connection for image transfer image and clip storage image review printing recording the ability to archive Doppler with audio output to a videotape and DICOM connectivity Currently the system supports the following broadband transducers C60e 5 2 MHz 60 mm curved array HFL38 13 6 MHz 25 mm linear array ICT 8 5 MHz 11 mm intracavitary array L38e 10 5 MHz 38 mm linear array P17 5 1 MHz 17 mm phased array TEE 8 3 MHz phased array System accessories include the following mobile docking system MDS MDS Lite mini dock Triple Transducer Connect a power supply a battery ECG cable video and printer cables and SiteLink Image Manager 3 0 software See the applicable SonoSite accessory user guide for information on the accessories System peripherals include medical grade conforming to the requirements of EN60601 1 and non medical commercial grade products System medical grade peripherals include a printer VCR and DVD System non medical grade peripherals include a CompactFlash card and a Kensington Security Cable System setup instructions
43. e CPD ROI While you are moving the CPD ROI you will see an Image outline of the new position moving on the display When you stop moving the new position will display the CPD ROI The size of the CPD ROl is fixed There is no control to change it Adjust CPD Turn gain clockwise to increase the amount of CPD gain While in CPD imaging near and far Gain affect only the 2D image they do not affect the CPD image Turn gain counterclockwise to decrease the amount of CPD gain 1 Image the vessel using a Doppler phantom Verify that as the gain controls increase and decrease Doppler echo intensity increases and decreases to correspond Verify that no flow exists outside the vessel 2 SaveaCPD image by pressing the Freeze key and then the Save key M Mode Imaging Test M Mode 1 Attach a C60e transducer and acquire an image Imaging 2 Press the M Mode key for the M Mode sample line 3 Position the M Mode sample line over the image using the touchpad 4 Press the M Mode key again to turn on M Mode 5 Select the desired sweep speed from the on screen menu slow med or fast The on screen menu will show the selected sweep speed 6 Press the Freeze key to freeze the image Press it again to return to live imaging 7 Pressthe 2D key to return to 2D imaging Tissue Harmonic Imaging Test THI 1 Imaging 2 3 4 5 Attach the C60e transducer and acquire an image Set the depth to maximum and note the depth at which echo information is lost
44. e 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 88 Appendix B Service Event Report SonoSite Index Numerics 2D performance tests axial measurement accuracy 70 image quality 70 lateral measurement accuracy 71 penetration 71 A AC power indicator 22 accessories 17 add new user 25 administrator login 24 alphanumeric 21 annotation description 21 assert code 53 assistance customer 1 battery install 38 installation 38 remove 38 safety 7 specifications 19 storage and shipping 19 troubleshooting diagram 57 battery charging test 73 C cable specifications 18 caliper calcs 22 cautions 5 CompactFlash install 39 remove 39 control panel assembly replacement procedure 62 troubleshooting diagram 55 conventions used 1 D date 30 default settings change to 37 delta key 31 depth description 21 DICOM connectivity 29 display assembly replacement procedure 59 troubleshooting diagram 54 duplex images 36 DVD setup 29 E electrical safety 5 equipment safety 6 error message 6 Ethernet 29 30 event log 26 export user account 26 F F keys 31 fetal age inaccurate calculation 52 forms 22 freeze description 22 G gain description 22 grace period 3 l image problem 51
45. e to accept or Cancel to cancel the upgrade When you accept the transducer software upgrade the system loads the new software and displays the following message Please wait transducer upgrade in progress Figure 4 11 Transducer Software Loading When the upgrade is completed the system displays the following message Figure 4 12 Transducer Software Installation 6 Select Restart When the transducer software has been replaced the system presents you with the license update screen so that you may license the software for your transducer Upgrade all transducers before obtaining license keys Repeat all steps in Upgrade Transducer Software Chapter 4 Setup and Operation 45 9 2005May03 10 12 Please enter a new license key or cancel Transducer this operation To obtain a license key 1 Contact SonoSite at 1 877 657 8118 www sonosite com service sonosite com 2 Supply the following a Your name b Transducer part c Transducer bundle version 20 80 200 001 R d Transducer serial 033K59 3 Enter license key Figure 4 13 Transducer License Screen At this point the software upgrade process is complete but the software is not yet licensed The following section Obtaining a License Key explains how to license your system and transducer software Note If you are upgrading additional transducers it is recommended to upgrade all items before calling SonoSite Technical Support for your license keys To post
46. electrical shock to the patient subject do not touch the system battery contacts while simultaneously touching a patient subject To prevent injury to the operator bystander the transducer must be removed from patient contact before the application of a high voltage defibrillation pulse To avoid possible electrical shock or electromagnetic interference verify proper operation and compliance with relevant safety standards for all equipment before clinical use Connecting additional equipment to the ultrasound system constitutes configuring a medical system SonoSite recommends verifying that the system all combinations of equipment and accessories connected to the ultrasound system comply with JACHO installation requirements and or safety standards such as AAMI ES1 NFPA 99 OR IEC Standard 60601 1 1 and electromagnetic compatibility standard IEC 60601 1 2 Electromagnetic compatibility and are certified according to IEC Standard 60950 Information Technology Equipment ITE Do not use the system if an error message appears on the image display note the error code call SonoSite or your local representative turn off the system by pressing and holding the power key until the system powers down To avoid increasing the system and transducer connector temperature do not block the airflow to the ventilation holes on the side of the system Equipment Safety WARNING To avoid the risk of a burn hazard do not use the transducer with high
47. elle dee 69 Setting Up Performance Tests ssccsssscsssescssssssssssssssscssssccsscsssssccssccssscesssecessscsssses 69 Scan Reference Orientation sssssccssesscscsssscccssescscsnsecessseseccsssesessnseeccesnseeeeeee 69 Testing 2D Performance qu ssssssssssccssssccsesccssssecsssccssseccssecesssessseecsssecsseessseessesessseees 70 2D Image Quality eet Scenccstessonsusedssussbesntbea scesndoutsvesstucetvessconsiusbbsiess 70 Axial Measurement ACCUraCy eessssesssssescsseescssesesseesssseecnseessnsecesnsseensesennsssenees 70 Lateral Measurement Accuracy 71 Penetration sss 71 Additional Performance Tests 72 CPD mcr 72 MMode Imagihg tirare thesi boire tet rerba reb tasaisia 72 Tissue Harmonic Imaging eerte tenete nttnnttnntnnntnnnes 72 Pulsed Wave PW Doppler Imaging eee 73 Image Quality Verification Test Livescan seen 73 linage Revier pte teste ite eter cepi tete celeste booa 73 Printer 73 Battery Charging 73 Video Output 74 Returning Products to SonoSite 74 Contacting SonoSite Technical Support 74 Shipping Instructions seessesssssecseecssccsssecssccssccessccsscesscsssccessccsuccsseceseecsscessees 74 Appendix A Parts List Replacement Parts List scssssssssecssecsecsssecssecsscssssesssecssccsescesseeseesssceeseeescesacesaserseees Bl Ee
48. em Disassembly for Repair and or Replacement Required Parts Parts for the Main System Repair could include any of the following P05472 Service Assembly Main PCBA MicroMaxx P05471 Service Assembly Power Supply MicroMaxx P05470 Service Assembly TGC MicroMaxx P05473 Service Assembly Speaker MicroMaxx P05474 Service Assembly Upper Enclosure MicroMaxx P05475 Service Assembly Lower Enclosure MicroMaxx Note Replacing the enclosure bottom requires printing a new label for the product This must be printed prior to shipping the enclosure bottom You will be required to provide the information to print this label Nest Frame Assembly MicroMaxx order these parts individually P00364 Connector Interposer P00524 Screw Shoulder Thrust Plate P00353 Wear Plate P00646 Spring Thrust Plate P02860 Nest Plate Interposer e P03834 Shield Perimeter Long P03833 Shield Perimeter Short e P02861 Post Mounting Required Tools 1 Phillips screwdriver Torque screwdriver 2 0 10 0 inch pounds 0 23 1 1 newton meter 8mmnut driver e An anti static mat e A wrist grounding strap 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 Main PCBA Removal Main PCBA 1 Remove the display and the control panel from the system following the removal Removal procedures in Display Removal on page 59
49. enu More More displays the list of user defined custom measurements and allows you to associate a custom table for the custom measurement This is only available when a user defined custom table has been created for the custom measurement Export 1 Inserta blank CompactFlash card in the back slot of the system 2 Press the Setup key 3 Select OB Calculations 4 Select Export from the on screen menu All user defined tables and measurements are copied to the CompactFlash card Import 1 Insert the CompactFlash card in the back slot of the system 2 Press the Setup key 3 Select OB Calculations 4 Select Import from the on screen menu 5 Afterall user defined tables and measurements are imported the system restarts Note All user defined tables and measurements currently on the system are replaced with imported data 6 Select Done from the on screen menu to return to live imaging Tables Tables displays system OB tables or is used to create custom OB tables See OB Custom Tables on page 35 Reset Select Reset from the on screen menu to return settings for this setup page to factory default Chapter 4 Setup and Operation 33 OB Custom Measurements Name Type Exam New J Delete Last J Name j 4 character max Type oma s Save J Cancel Figure 16 Setup Screen OB Custom Measurements OB Custom 1 Press the Setup key Measurements 2 Select OB Custom Meas 3 Select New 4 Inthe
50. er 6 P03834 Shield Perimeter Long 7 P03833 Shield Perimeter Short 8 P02861 Post Mounting Ordering Replacement Parts To order parts contact SonoSite Technical Support as indicated in Returning Products to SonoSite on page 74 84 Appendix A Parts List Bi Sono ite Appendix B Service Event Report 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 return a copy of it to the following address SonoSite Inc Technical Support 21919 30th Drive SE Bothell Washington 98021 USA Technical Support USA Canada 1 877 657 8118 Technical Support fax 1 425 951 6700 Technical Support e mail service sonosite com SonoSite website www sonosite com and select 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 jp sonosite com Appendix B Service Event Report 85 86 Appendix B Service Event Report SonoSite Bi Sonosite Service Event Report Carrying Ultrasound into the Future Instructions on reverse Service Request For SonoSite Use Only Order Number RMA Number Service Provider Name Provider Reference Com
51. eration scssssccssssssecseccssscsssecssecssecssscesscesesecseecssess 38 Installing and Removing the Battery sees 38 Installing and Removing the CompactFlash Card 39 Using AC Power Charging Battery eene Connecting and Removing the Transducer Turning System On Off eseccssssscccssessecsssseccessssccessseeccesseeecessseesssnseesssnseeessnseess Upgrading the System and Transducer Software sss 42 Upgrading Triple Transducer Connect TTC sss 46 Obtaining a License Key essssssscsssesssecssecssecsscccssecsscsssseeseesscesssesseessseesseeese Installing a License Key To Display the System Information Screen E To Display the License Update Screen ees Chapter 5 Cleaning and Disinfecting Universal PrecautiOns eere tette tete tnntn tette tette tette teste tn tn 49 Receipt of Suspected Contaminated Materials sss 49 Recommended Disinfectants eet tte tttnttnntenntn tiens 49 Chapter 6 Troubleshooting Basic Troubleshooting csscssssescrissssrusccnssssessssstassonnassonssoonsussatasecnssssenssesassssdnsvenatsstesssenes 51 Periodic Maintenance cescssssccsssescstsscsseecessccsssecssesecssscessssccsuseessesessnsesessecssesessseees 52 System and Subsystem Diagnosis sescssesccssesscssescssssecssesessecesssese
52. ert is identified here Assert Cause 1 2 3 Record the assert code Press the Power button and release it to power the system down Press the Power button again to power on the system Ifthe system powers on normally it has recovered from the fault software assert and you may use the system e Ifthe assert condition remains corrective action must be taken usually replacement of the main PCBA is required Contact SonoSite Technical Support for assistance and to obtain repair parts If the Power button is not functional all sources of power must be removed to allow the system to power down i e disconnect AC power and remove the battery Chapter 6 Troubleshooting 53 Troubleshooting Flow Diagrams Display No Image On MicroMAXX System Display Install MicroMAXX System Into Mobile Docking System Or To MiniDock Attach A Working External Monitor To A Video Connector On The Rear Of The Docking System Used Power The System On xtema Monitor No mor ua OK Yes Replace Internal Display Corrected Perform Image Quality Tests Figure 6 2 Display Flow Diagram 54 Chapter 6 Troubleshooting Replace MiniDock xtema Monitor OK Yes Internal Monitor OK Yes Replace Internal Display Verify all Connections and Return to Beginning of Troubleshooting Diagram BSonoSite Control Panel MicroMAXX Control Panel Has A Failure
53. fer of recalled from storage for review on the system Images or data displayed on the screen Images and Data may be captured on an external video printer or video recorder or be transferred to a personal computer DICOM IMT The system features Digital Imaging and Communications DICOM capability to provide the acceptance transfer display storage and digital processing of single ultrasound images as well as loops of Ultrasound images The system includes the ability to measure the intima media thickness IMT of the carotid artery using digital ultrasound images The intima is that region of the arterial wall from and including the endothelial surface at the lumen to the luminal margin of the media The media layer extends from the intima to the adventitia of the vessel wall The adventitia is normally quite echogenic on ultrasound images when compared to the media The IMT measurement of the carotid artery may be used adjunctively with other medical data obtained by a physician to help assess the cardiovascular health of a patient System Specifications This section contains system and accessory specifications and agency approvals The specifications for recommended peripherals can be found in the manufacturers instructions System Dimensions Length 11 8 in 29 97 cm Width 10 8 in 27 43 cm Height 3 1 in 7 87 cm Weight 8 5 Ibs 3 9 kg with the C60e transducer and battery installed Display Dimensions Length 8
54. for the use of peripherals are covered in the MicroMaxx Ultrasound System User Guide Manufacturer s instructions accompany each peripheral Instructions for the use of peripherals with the system are covered in the applicable SonoSite accessory user guide About the System Software The ultrasound system contains software that controls its operation A software upgrade may be required for new feature releases Should an upgrade be required SonoSite will provide you with a CompactFlash card containing the software A single CompactFlash card can be used to update one or more systems Software upgrades use the back CompactFlash slot on the right hand side of the system CompactFlash cards installed in the front CompactFlash slot do not upgrade the system Software Licensing SonoSite software is controlled by a license key which is obtained from SonoSite or from its authorized representatives You must obtain one key for each system or transducer that will use the new software See Obtaining a License Key on page 46 The software may be installed and will operate for a short period of time without requiring a valid license key We refer to this period of time as the grace period The grace period is variable When you first install your software your SonoSite system prompts you for a license key If you have not yet obtained a valid license key you can elect to use the software as long as the grace period time has not been fully consumed Whe
55. formance Tests Setup 1 Attach the C60e 5 2 MHz transducer to the system Performance 2 Select general for optimization and OB for exam type Tests 3 Couplethe transducer to the phantom adjusting gain settings and transducer for a proper phantom image e g pins are high level echoes positioned in straight lines cysts are sonolucent edges are sharp and graphite particles of the phantom are mid grays Scan Reference Orientation Set up Scan 1 Verify that the correct transducer name appears in the upper right corner of the system Reference display Orientation 2 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 3 With the array pointing down and the orientation mark to the operator s left element 1 corresponds with the left side of the array Chapter 8 Performance Testing 69 Testing 2D Performance Test 2D 1 Use a C60e 5 2 MHz transducer in 2D mode Performance 2 Adjustthe position of the C60e 5 2 MHz transducer on the phantom 3 Usethe 2D system controls to obtain a clear image that shows both the horizontal and vertical rows of pins 2D Image Quality Test 2D Image 1 Verify that the ultrasound image appears uniform in both the axial and lateral direction
56. frequency surgical equipment Such a hazard may occur in the event of a defect in the high frequency surgical neutral electrode connection To protect your ultrasound system transducer and accessories follow these precautions Caution Excessive bending or twisting of cables can cause a failure or intermittent operation Improper cleaning or disinfecting of any part of the system can cause permanent damage For cleaning and disinfecting instructions see the MicroMaxx Ultrasound System User Guide Do not submerge the transducer connector in solution The cable is not liquid tight beyond the transducer connector cable interface Do not use solvents such as thinner or benzene or abrasive cleaners on any part of the system Remove the battery from the system if the system is not likely to be used for some time Do not spill liquid on the system Accessible metal of the mini dock is not protectively earthed Do not perform high current grounding impedance test involving this part Chapter 2 Safety Sono Site Battery Safety To prevent the battery from bursting igniting or emitting fumes and causing personal injury or equipment damage observe the following precautions WARNING Caution The battery has a safety device Do not disassemble or alter the battery Charge the batteries only when the ambient temperature is between 0 and 40 C 32 and 104 F Do not short circuit the battery by directly connecting the
57. g block floating scaling to retain maximum precision The resulting output is later normalized during magnitude computation Chapter 3 System Overview 13 Magnitude This module combines real and imaginary components to estimate magnitude spectrum Estimation The magnitude of Doppler spectrum is calculated using cordic approximation which is done by estimating the complex magnitude by successive approximation The vectors are reflected into the first quadrant by taking the absolute value then rotating them sequentially by halved degrees Temporal Spectral lines are produced by the FFT module at a constant rate This module averages the Averaging appropriate number of spectral lines to produce output lines at the desired display scroll rate Compression The compression module maps the input spectral magnitude values to display output values Velocity Color Doppler VCD 14 In Velocity 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 structur
58. ge storage and retrieval memory external communication interface ports and connection to the user interface keys The control software includes the acoustic power and intensity software subsystem power group monitors and a beamformer monitor This software guarantees a level of patient safety by ensuring the system is operating within acoustic power and intensity limits The User Interface Subsystem represents the software interface and form factor The software interface is the interaction between the user and the screen layout components The form factor is the type of physical buttons location and grouping of the buttons and the device size shape and weight Dedicated controls are for high usage activities and grouped according to the user workflow The Power Subsystem provides the system power and protects the hardware from destructive and or unsafe conditions by detecting failures in the system through hardware and software monitors Detection of a fault results in disabling of the pulser supply and signaling of an error to the Control Group The power subsystem includes the battery pack and battery charging electronics Description of Operating Modes 2D Mode 2D mode is a two dimensional image of the amplitude of the echo signal It is used for location and measurement of anatomical structures and for spatial orientation during operation of other modes In 2D a two dimensional cross section of a 3 dimensional soft tissue structure such
59. he speaker wires Replace the power supply assembly Replace the TGC assembly Reinstall the shield to the Power Supply Tighten all screws to their specified torque of 5 5 inch pounds NOW BPWN 68 Chapter 7 Replacement Procedures SonoSite 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 Verify that all controls operate smoothly over their full range and that the system responds properly Toobtain 2D images SonoSite recommends using the RMI 413A Soft Tissue Phantom or the RMI 403 GS Multipurpose Phantom Any equivalent Phantom is acceptable Toobtain Power Doppler images SonoSite recommends using the RMI 425 Doppler Phantom or the RMI 1425A Doppler Phantom Any equivalent Phantom is acceptable When making penetration measurements on a phantom apply the phantom reference value and tolerance to the measurement Test Equipment SonoSite ultrasound system under test e C60e 5 2 MHz transducer P17 5 1 MHz transducer RMI 413A Soft Tissue Phantom RMI 403 GS Multipurpose Phantom or the equivalent RMI 425 Doppler Phantom RMI 1425A Doppler Phantom or the equivalent e Video Printer External Monitor e Acoustic gel Setting Up Per
60. he system prompts the user that the transducer requires the upgrade Upgrade 1 Remove any transducer or Triple Transducer Connect from the system System 2 Connect the system directly to the power supply or through the MDS mini dock See the Software SonoSite accessories user guide 3 Insert the CompactFlash card into the back slot The system displays the following message Figure 4 3 Upgrade System Software 4 Select Yes to accept or No to cancel the upgrade When you accept the system software upgrade the system begins to load the new software and prepare for the upgrade and displays the following message Figure 4 4 System Software Loading When the software upgrade has prepared the system for upgrade the system displays the following message Chapter 4 Setup and Operation SonoSite 2003Jun17 23 04 Figure 4 5 System Software Step 1 Restart 5 Select Restart After restart there is a short delay before the system goes into the upgrade process Do not turn the system off The system displays the following message Figure 4 6 System Software Installation When the upgrade is completed the system displays the following message Figure 4 7 System Software Step 2 Restart 6 Select Restart When the operating software has been replaced the system presents you with the license update screen so that you may license the software If upgrading a transducer press Cancel from the on screen menu Chapter 4
61. ify the display operates correctly Control Panel Subassembly Replacement Required Parts P05462 Service Assembly Control Panel MicroMaxx English or P05464 Service Assembly Control Panel MicroMaxx English International or P05465 Service Assembly Control Panel MicroMaxx French or P05466 Service Assembly Control Panel MicroMaxx German or P05467 Service Assembly Control Panel MicroMaxx Italian or P05468 Service Assembly Control Panel MicroMaxx Spanish or P05469 Service Assembly Control Panel MicroMaxx Portuguese Required Tools 1 Phillips screwdriver Torque screwdriver 2 0 10 0 inch pounds 0 23 1 1 newton meter 8mmnut driver Ananti static mat Awrist grounding strap 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 Control Panel Removal Control Panel 1 Remove the two screws from the rear of the system per Figure 7 1 Removal 2 Remove the two screws from the bottom of the system per Figure 7 2 3 Turn the system over fully open the display and lift off the Control Panel per Figure 7 3 Control Panel Replacement Control Panel 1 Place the new control panel in place Replacement 2 Install the four screws removed in Control Panel Removal on page 62 Torque the screws to 5 5 inch pounds 62 Chapter 7 Replacement Procedures SonoSite Main Syst
62. ime 1 Press the Setup key 2 Select Date and Time 3 Inthe Time field enter the current time in 24 hour format hours and minutes Reset Select Reset from the on screen menu to return settings for this setup page to factory default 30 Chapter 4 Setup and Operation SonoSite Delta Key and F Keys d 2005Apr22 13 48 Delta Key Clips menu Figure 12 Setup Screen Delta Key F Keys Delta Key 1 Press the Setup key 2 Select Delta Key F Keys 3 Select desired functionality for the Delta key The Delta key will now control this function F Keys 1 Press the Setup key 2 Select Delta Key F Keys 3 Type desired text Use the Backspace key or Delete key to correct mistakes Reset Select Reset from the on screen menu to return settings for this setup page to factory default Display Information 2 2005May05 10 57 Institution Date and Time Doppler F M Mode F VCR record F Delta Key Figure 13 Setup Screen Display Information Patient Header 1 Press the Setup key 2 Select Display Information 3 Selectthe desired check boxes to display desired information in the patient header Mode Data 1 Press the Setup key 2 Select Display Information 3 Select the desired check boxes to display imaging information on the screen Chapter 4 Setup and Operation 31 System Status 1 Press the Setup key 2 Select Display Information 3 Select the desired check boxes to display the system status on the scree
63. ing Off allows access to the system and does not require the user to enter a user name and password After making changes in the Administration setup reboot the system to log off as administrator Wo 2005Apr22 13 37 7 Delete r Administration Access Save J Cancel EE eet pote Figure 6 Setup Screen User List Information Add New User Select New In User Information enter information in Name Password and Confirm fields To ensure passwords are secure it is recommended that passwords contain characters from the following categories Upper case characters A Z Lower case characters a z Numbers 0 9 Note The name and password are case sensitive In Sonographer enter the user s initials to display the information in the patient header and the sonographer field in the Patient Information form Optional In Administration Access click the check box to allow users access to all administration privileges or leave unchecked to restrict access Optional Select Save Modify User Information In the User List select desired user name Enter the new name Enter the new password and confirm Select Save Any change to the user name replaces the old name Delete User 1 In the User List select the desired user name Select Delete A dialog is displayed Select Yes to delete or No to cancel Change User Password 1 In the User List select the desired user name 2 Enter the new passwo
64. ing peripherals Medical Grade Black and white printer Recommended sources for printer paper Contact Sony at 1 800 686 7669 or www sony com professional to order supplies or to obtain the name and number of the local distributor Color printer Video cassette recorder Non Medical Grade Kensington Security Cable Temperature Pressure and Humidity Limits Note The temperature pressure and humidity limits apply only to the ultrasound system and transducers Operating Limits System e 10 40 C 50 104 F 15 95 R H e 700 to 1060hPa 0 7 to 1 05 ATM Shipping Storage Limits System without Battery e 35 65 C 31 149 F 15 95 R H 500 to 1060hPa 0 5 to 1 05 ATM Operating Limits Battery e 10 40 C 50 104 F 15 95 R H Shipping Storage Limits Battery e 20 60 C 4 140 F 0 95 R H 500 to 1060hPa 0 5 to 1 05 ATM For storage longer than 30 days store at or below room temperature Operating Limits Transducer 10 40 C 50 104 F 15 95 R H Shipping Storage Limits Transducer e 35 65 C 31 149 F 15 95 R H Electrical Power Supply Input 100 240 VAC 50 60 Hz 1 2 A Max 100 VAC Power Supply Output system on 1 15 VDC 2 7A Max system 2 12 6 VDC 0 8A Max battery charging Power Supply Output system off 1 15 VDC 2 0A Max system 2 12 6 VDC 1 8A Max battery charging Combined output not exceeding 52W Battery 6 cell 11 25 VDC 4 4 amp hours rechargeable lithiu
65. ler VCD Additional System Feature Performances 15 EGCG MOGUIE t M 16 pao M 17 M acetic 17 System Specifications System Dimensions milf Displ y DIMENSIONS MR 17 TWAS COTS E ETNE TE EATE E E EAE 17 ontto ilare Rio To ELE eA ASE EAE 18 TonzTe ESIS E 1 EEE A E E EE E E E 18 Accessories Peripherals Temperature Pressure and Humidity Limits sss 19 A e eoe AE PE EE TE 19 arg 19 Electromechanical Safety Standards 20 EMC Standards Classification 20 Airborne Equipment Standards we 20 DICOM Europ 20 HIPAA Standard ucro nettes pre ri rer kiere repe dteh 20 Chapter 4 Setup and Operation yrs COMEOIS c System Eelsjeelr sp cap R ruo Setup Security Settings ee Audio and Battery se ssccsisacsccssseshosenssssosdasooosessnsstasesessivesscansuestsnssiocestevoncessinosdbeads eefulntsieua c Date and ME ea e Delta Key and F Keys csssssssssssssssssecssessscsssssessscssccssseessccssscsssecsscsssecesscesscesseesase Display Information m eI NS nnna iiaii OB Calculations Authors OB Custom Measurements s ierat PRES EUS Mee 9 System Information isisisi iniiis innii Touchpad iiaeo naa aa EEEE SE Accessories Preparing the System for Op
66. m ion battery pack Run time is 2 hours or more depending on imaging mode and display brightness Chapter 3 System Overview 19 Electromechanical Safety Standards 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 2 37 2001 European Norm Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment CAN CSA C22 2 No 601 1 M90 1990 Canadian Standards Association Medical Electrical Equipment Part 1 General Requirements for Safety CEI IEC 61157 1992 International Electrotechnical Commission Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment UL 60601 1 2003 Underwriters Laboratories Medical Electrical Equipment Part 1 General Requirements for Safety 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
67. n Reset Select Reset from the on screen menu to return settings for this setup page to factory default IMT Calculations Setup Pages IMT Calculations fA N Anterior near Ant F Anterior fer CiN atersi near x Lat F ateraia sj Post N Posterior near Post F Posterior far MT 1 IMT2 Region width mm 10 1 20 ENN 10 1 NM Figure 14 Setup Screen IMT Calculations IMT Calculations 1 Press the Setup key Select IMT Calculations 3 Inthe IMT calculations list select the desired labels Selecting a label places the measurement on the Calculation menu and within the report Selecting None removes a label Reset Select Reset from the on screen menu to return settings for this setup page to factory default 32 Chapter 4 Setup and Operation SonoSite OB Calculations Authors Gestational Age GS Nyberg APTO None CRL Hadiock AC Hadlock BPD Hadiock FTA None OFD None FL Hadlock EFW Hadlock BPD Hadiock EFW Hadlock HC Hadiock HC AC Campbell AC Hadiock FL Hadiock Figure 15 Setup Screen OB Calculations Gestational Age Growth Analysis Press the Setup key Select OB Calculations 3 In Gestational Age or Growth Analysis lists select the desired OB authors Selecting an author places the measurement on the calculation menu and selecting None removes the measurement from the calculation m
68. n a system is running in the grace period all system functions are available As you use the system the grace period is slowly consumed When the grace period has expired the system will not be usable until a valid license key has been entered Grace period time is not consumed while the system is powered off or when it is in sleep mode Whenever a system is running in the grace period the grace period time remaining is available on the license update screen Caution When the grace period expires all system functions except for licensing are unavailable until a valid license key is entered into the system Chapter 1 Introduction 3 4 Chapter 1 Introduction E Sono ite Chapter 2 Safety Read this information before using the ultrasound system The information in this manual applies to the ultrasound system transducer accessories and peripherals This chapter contains safety information A WARNING describes precautions necessary to prevent injury or loss of life A Caution describes precautions necessary to protect the products Electrical Safety This system meets EN60601 1 Class l internally powered equipment requirements and Type BF isolated patient applied parts safety requirements This system complies with the applicable medical equipment requirements published in the Canadian Standards Association CSA European Norm Harmonized Standards and Underwriters Laboratories UL safety standards See the MicroMaxx Ultras
69. n the upper right hand section of the display indicates the current battery level All Battery Indicator segments lit mean the system battery is fully charged Some Battery Indicator segments lit mean the system battery is partially charged When the battery is charging the Battery Indicator segments light sequentially Table 4 3 contains the charging specifications for the system Table 4 3 System Charging Specification System Charging Parameter Specification Charge time to 8096 capacity with System power off 3 hours 25 C Charge time to 8096 capacity with System power on 6 hours 25 C 40 Chapter 4 Setup and Operation SonoSite Connecting and Removing the Transducer WARNING To avoid injury to the patient do not place the connector on the patient Operate the ultrasound system in the MDS or on a flat hard surface to allow air flow past the connector Caution To avoid damaging the transducer connector do not allow foreign material in the connector Figure 4 2 Connect the Transducer Connect 1 Turn the system upside down if not in MDS Transducerto 2 Pullthe transducer latch up and rotate it clockwise System 3 Align the transducer connector with the connector on the bottom of the system 4 Insert the transducer connector into the system connector 5 Turn the latch counterclockwise 6 Pressthe latch down securing the transducer connector to the system Remove 1 Pull the latch up and rotate it clockwise
70. nal This block also provides a high pass function to eliminate any large direct current DC offsets to allow a moderately high gain to be set before isolation allowing the front end to set the input equivalent noise of the electrical ECG signal path Isolation The isolation block provides voltage isolation for the analog signal The voltage isolation between the patient and the system meets the requirement of the ANSI AAMI EC13 specification High Pass Filter The high pass filter block removes the low frequency components and biases the opt coupler output for the received ECG signal Variable The variable amplifier blocks provide additional gain for the received ECG signal The Amplifier blocks are used to boost the signal There are three gain settings for the variable amplifier controlled by the system through the control bus 16 Chapter 3 System Overview SonoSite Low Pass Filter The low pass filter block removes the high frequency component from the received ECG signal It is used to limit the signal to the frequency range of interest and provide rejection of 50 60 Hz signal content Power Supplies The power supply block receives voltage from the system power supply It also generates isolation power supplies for the pre amplifier and isolation blocks It can be disabled to reduce power consumption while the module is not in use Digital Storage The System stores images and data internally for review Data and images may be and Trans
71. nal power Figure 3 1 SonoSite High Resolution Ultrasound System MicroMaxx 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 128 elements The Acquisition Subsystem consists of the beamformer and interface to the transducer The beamformer times the transmit pulses to focus the acoustic beam The beamformer amplifies the low level echo signal and times the receive information to focus the receive information The system beamformers up to 64 transmit elements and 64 receive 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 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 Chapter 3 System Overview SonoSite The Control Subsystem consists of the central processing unit program and video memory permanent ima
72. nce transfer display storage and digital processing of ultrasound images and loops Security support is also provided to facilitate HIPAA compliance The System Transducer is capable of exceeding a Tl or an MI of 1 0 in certain operating modes or mode combinations The System monitor displays the current output level in terms of one of two bioeffects indices Mechanical Index MI and Thermal Index TI in accordance with the AJUM NEMA Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Chapter 3 System Overview 9 Theory of Operation 10 The SonoSite High Resolution Ultrasound System MicroMaxx has seven 7 major functional groups Transducer e Acquisition Subsystem Processing Subsystem e Display Subsystem Control Subsystem User Interface Subsystem Power Subsystem Figure 3 1 is a system block diagram that shows the relationship of the functional groups L External video to monitor VCR printer Acquisition RF Bus Processing AQ Bus Display subsystem subsystem subsystem Video gt User interface IrDA 4 Control Control Bus subsystem Serial Bus pm Power subsystem Battery pack m Display power gt assembly Transducer TUN w ICP Pulser voltage lt a t Power adapter Exter
73. nd SiteLink are optional features Configure Date and Time functions Configure existing system functionality as a shortcut and create predefined labels for images Configure information displayed on image patient information mode data and system status data Configure the IMT calculation menu and presets Select OB calculation authors Configure system for user defined measurements OB Custom Measurements are an optional feature Configure Preset functions Doppler Scale Duplex Live Trace Thermal Index Save Key and Dynamic Range Displays system hardware and software versions Chapter 4 Setup and Operation 23 Setup Security Settings Security Setup WARNING Health care providers who maintain or transmit health information are required by the Health Insurance Portability and Accountability Act HIPAA of 1996 and the European Union Data Protection Directive 95 46 EC to implement appropriate procedures to ensure the integrity and confidentiality of information to protect against any reasonably anticipated threats or hazards to the security or integrity of the information or unauthorized uses or disclosures of the information SonoSite provides a comprehensive set of tools on the system that allows its customers to meet the applicable security requirements listed in the HIPAA standard SonoSite s customers are ultimately responsible for ensuring the security and protection of all electronic protected health informa
74. o provides needle guidance for vascular access procedures Additional information regarding this feature can be found in the biopsy user guides The System offers a variety of measurements and calculations specific to exam type and transducer A listing of the volume cardiac Doppler and obstetrical calculations and measurements that may be made is provided in the User Guide in the chapter Measurements and Calculations and author reference in provided the chapter References Measurement accuracy is discussed the Reference chapter of the User Guide 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 monaural output with the single audio output representing the summation of the flow directions The System provides for audio output of the PW 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 ECG is provided to measure the electrical signal generated by the heart A three lead interface Right Arm RA Left Arm LA and Left Leg LL is provided on the System The ECG signal is displayed as an amplitude versus time sweeping output Amplitude is presented on the vertical axis with time along the ho
75. obs 3 Figure 7 11 TGC Knobs 2 Remove the flex cable from the TGC PCB by lifting on the flex release tab See Figure 7 12 3 Remove the flex cable from the Main PCBA by lifting gently on the flex release tab 4 Remove the two screws holding the TGC PCBA in place Release tabs Screws 2 Figure 7 12 TGC Removal Chapter 7 Replacement Procedures 67 Main PCBA Main PCBA 1 Remove the 3 screws holding the Main PCBA in place per Figure 7 13 2 Remove the 4 shoulder bolts holding the transducer nest frame assembly in place 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 3 Remove the 2 screws located on the CompactFlash assemblies Disconnect the speaker wires from the Main PCBA 5 Remove the TGC PCBA following the procedure in TGC PCBA on page 67 Screws 3 Screws 2 CompactFlash release buttons Shoulder bolts 4 Figure 7 13 Main PCBA Screws 6 Lift on the edge of the Main PCBA closest to the system handle Note As the Main PCBA is removed press in on the CompactFlash release buttons so they clear the opening in the bottom enclosure Main PCBA Replacement Main PCBA Replace the Main PCBA by following the reverse of the removal procedure Do not tighten all the Replacement screws until everything is in place Replace the Main PCBA Replace the Nest Frame Assembly Reconnect t
76. om the system See Installing and Removing the Battery on page 38 Removal for battery removal 2 Remove the two screws from the back of the system per Figure 7 1 Screws 2 Figure 7 1 System Rear 3 Lay the system on the top and remove the two screws from the bottom of the system per Figure 7 2 Chapter 7 Replacement Procedures 59 Screws 2 MicroMaxx Ultrasound sen m REF P05294 02 Figure 7 2 System Bottom 4 Turn the system over fully open the display and lift off the Control Panel per Figure 7 3 Figure 7 3 Control Panel Removal 5 Disconnect the two connectors from the display to the Main PCBA per Figure 7 4 60 Chapter 7 Replacement Procedures SonoSite Connectors 2 Figure 7 4 Display Connectors 6 Remove the four screws from the Display Hinges per Figure 7 5 Screws 4 Figure 7 5 Display Screws Display Replacement Display 1 Set the new display in place Replacement 2 Install the four screws that hold the Display in place Torque the screws to 5 5 inch pounds 3 Connect the two connectors that connect the Display to the Main PCBA 4 Placethe Control Panel in place 5 Reinstall the four screws that hold the Control Panel in place Torque the screws to 5 5 inch pounds Chapter 7 Replacement Procedures 61 Test the Display Test Display 1 Replace the battery attach an external power supply or attach a mini dock 2 Pressthe Power key to apply power to the system 3 Ver
77. or information about accessories and other SonoSite products refer to the user guide for each product Preparing the System for Operation Installing and Removing the Battery Caution Use only the specified SonoSite battery pack For battery safety notes see Battery Safety on page 7 The battery comprises six lithium ion cells plus electronics a temperature sensor and battery contacts If the battery is being installed for the first time it will need to be charged WARNING To avoid injury to the operator and to prevent damage to the ultrasound system inspect the battery for leaks prior to installing Locking levers Figure 4 1 Insert Battery into System Install Battery 1 Disconnect the power supply from the ultrasound system Turn the system upside down Place the battery into the battery compartment at a slight angle See Figure 4 1 Slide the battery forward until it locks into place Push down on the two locking levers to secure battery Ui BW MN Remove Battery Push up on the two locking levers Slide the battery back 3 Lift the battery from the compartment N 38 Chapter 4 Setup and Operation SonoSite Installing and Removing the CompactFlash Card Images and clips are saved to a CompactFlash card and are organized in a patient list The images and clips in the patient list are organized alphabetically by the patient name and ID Images and clips are archived from the ultrasound
78. oubleshooting for troubleshooting procedures Returning Products to SonoSite Contacting SonoSite Technical Support Technical Support USA Canada 1 877 657 8118 Technical Support fax 1 425 951 6700 Technical Support e mail service sonosite com SonoSite website www sonosite com and select 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 jpesonosite com 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 Attn Technical Support RMA 21919 30th Drive SE Bothell Washington 98021 USA 74 Chapter 8 Performance Testing SonoSite Appendix A Parts List This section contains a list of field replaceable parts Replacement Parts List The following tables contain all the replaceable parts for the MicroMaxx Ultrasound System All quantities are one unless otherwise noted Display Table A 1 Display Find Number Part Number Description P05463 Service Assembly Display MicroMaxx 1 P02619 Hinge 2 P02172 Wire harne
79. ound System User Guide Specifications chapter For maximum safety observe the following warnings and cautions WARNING To avoid discomfort or minor risk of patient injury keep hot surfaces away from the patient Under certain circumstances the transducer connector and back of the display enclosure can reach temperatures that exceed EN60601 1 limits for patient contact therefore only the operator shall handle the system This does not include the transducer face To avoid discomfort or minor risk of operator injury when handling the transducer connector the system should not be operated for more than 60 minutes continuously in a live scan mode as opposed to freeze or sleep modes To avoid the risk of electrical shock or injury do not open the system enclosures All internal adjustments and replacements except battery replacement must be made by a qualified technician To avoid the risk of injury do not operate the system in the presence of flammable gasses or anesthetics Explosion can result To avoid the risk of electrical shock use only properly grounded equipment Shock hazards exist if the power supply is not properly grounded Grounding reliability can only be achieved when equipment is connected to a receptacle marked Hospital Only or Hospital Grade or the equivalent The grounding wire must not be removed or defeated To avoid the risk of electrical shock before using the transducer inspect the transducer face
80. pany Date Reported Address Phone Number Fax Number E mail address Device Description Name Ref Number ARM SHDB Version Event Description Diagnosis Service Performed Performed By Date Parts Removed Part Number Serial Number Lot Number Rev Replaced By Parts Installed Part Number Serial Number Lot Number Rev Replaced By Tests Performed attach test data Test Test Performed By Performed By Result Pass Fail Result Pass Fail 7 Attach additional sheets as required Page of F00019 Rev D Appendix B Service Event Report 87 Instructions for completing the Service Event Report The sections highlighted in yellow are the minimum that must be completed for us to accept a Service Event Report If we need additional information we will let you know Forward completed form to Email service sonosite com Fax 1 425 951 6700 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 Can be in any format Company the name of the Dealer Company or authorized repair site 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 N
81. patial orientation the full color blood flow cross section is overlaid on top of the gray scale cross section of soft tissue structure 2D echo For each pixel in the overlay the decision of whether to display CPD gray scale echo information or a blended combination is based on the relative strength of echoes from the soft tissue structures and from the red blood cells A high pass filter wall filter is used to remove the signals from stationary or slowly moving structures Tissue motion is discriminated from blood flow by assuming that blood is moving faster than the surrounding tissue although additional parameters may also be used to enhance the discrimination The power in the remaining signal after wall filtering may be averaged over time persistence to present a steady state image of blood flow distribution Chapter 3 System Overview 11 12 Continuous Wave CW Doppler Pulsed Wave PW Doppler CW 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 CW Doppler mode provides the clinician with the ability to obtain blood flow velocities focused about a user specified focal region A continuous transmit waveform of ultrasound energy with a known frequency is transmitted and focused by the System
82. pone obtaining a license key press Cancel from the on screen menu Upgrading Triple Transducer Connect TTC Upgrade TTC Ifthe TTC requires an upgrade for the MicroMaxx system the following message is displayed Do you want to upgrade the Triple Transducer Connect now If this message is displayed perform the upgrade Select Yes to accept and No to cancel the upgrade Ifyou select Yes the system presents you with the license update screen so that you may license the software See Obtaining a License Key on page 46 to license your software If you select No the system restarts Obtaining a License Key A license key is required to update your system It may be obtained by contacting SonoSite Inc Technical Support Department Technical Support USA Canada 1 877 657 8118 Technical Support fax 1 425 951 6700 Technical Support e mail service sonosite com SonoSite website www sonosite com and select 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 jpesonosite com 46 Chapter 4 Setup and Operation SonoSite To receive your license key you will need to provide the following information which is displayed on the system information screen of your system Table 4 4 Software License Key Information System Software Transducer Software
83. positive and negative terminals with metal objects Do not heat the battery or discard it in a fire Do not expose the battery to temperatures over 60 C 140 F Keep it away from fire and other heat sources Do not charge the battery near a heat source such as a fire or heater Do not leave the battery in direct sunlight Do not pierce the battery with a sharp object hit it or step on it Do not use a damaged battery Do not solder a battery The polarity of the battery terminals are fixed and cannot be switched or reversed Do not force the battery into the system Do not connect the battery to an electrical power outlet Do not continue recharging the battery if it does not recharge after two successive six hour charging cycles If the battery leaks or emits an odor remove it from all possible flammable sources To avoid the battery bursting igniting or emitting fumes from the battery and causing equipment damage observe the following precautions Do not immerse the battery in water or allow it to get wet Do not put the battery into a microwave oven or pressurized container If the battery emits an odor or heat is deformed or discolored or in any way appears abnormal during use recharging or storage immediately remove it and stop using it If you have any questions about the battery consult SonoSite or your local representative Store the battery between 20 C 4 F and 60 C 140 F Use only SonoSite bat
84. rd and confirm 3 Select Save Done Select Done from the on screen menu to return to live imaging Chapter 4 Setup and Operation 25 Export or Import User Accounts Note Export and import are used to configure multiple systems and to back up user account information Export User Account 1 Insert the CompactFlash card in the back slot of the system See Installing and Removing the CompactFlash Card on page 39 2 Pressthe Setup key 3 Select Administration 4 Select Export from the on screen menu All user names and passwords are copied to the CompactFlash card 5 Remove the CompactFlash card Import User Account 1 Insert the CompactFlash card in the back slot of the system See Installing and Removing the CompactFlash Card on page 39 2 Press the Setup key 3 Select Administration 4 Select Import from the on screen menu A dialog box is displayed 5 After all user names and passwords are imported the system restarts Note All user names and passwords currently on the system are replaced with the imported data Reset Select Reset from the on screen menu to return settings for this setup page to factory default Export and Clear Event Log The Event Log collects errors and events and can be exported to a CompactFlash card and read by a CompactFlash reader 2005MayO4 13 68 Event Log 2008 06 04 13 56 User Useri added 2005 06 04 13 56 User User2 added 2005 06 04 13 57 User User3 added 2005 06
85. rizontal axis Chapter 3 System Overview 15 ECG Module The ECG module allows a representation of the heart electrical activity to be displayed in real time with ultrasound images acquired and displayed on the System video display The ECG module interfaces to the patient through three 3 ECG leads Right Arm ECG lead RA Left Arm ECG lead LA and Left Leg ECG lead LL The ECG received signal from the ECG electrodes are isolated amplified and filtered by the ECG module before it is sent to the System for further processing and display The ECG module and cable are an integrated assembly The module receives power from the System Patient isolation is provided by the ECG module allowing the connection and signals to the System to be System ground referenced The isolation between the patient and the System meets the requirements of IEC 601 1 for Type BF equipment The top level functional block diagram is shown in Figure 3 3 Analog out ECG leads To patient ECG Module To system 3 Sense VPWR I2C BUS FLTR CLK PWR CLK From system Figure 3 3 ECG Module Block Diagram The ECG module can be partitioned into six 6 different blocks Pre amplifier block Isolation block High pass filter block e Variable amplifier block Low pass filter block Power supplies block Pre Amplifier The pre amplifier block provides the interface to the ECG leads It provides high levels of common mode rejection and the initial gain for the ECG sig
86. sentative For information about a specific product call the product manufacturer Recommended Disinfectants For a list of disinfectants recommended for use on the system and transducers see the MicroMaxx Ultrasound System User Guide Chapter 5 Cleaning and Disinfecting 49 50 Chapter 5 Cleaning and Disinfecting SonoSite Basic Troubleshooting Chapter 6 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 If you encounter difficulty with the system use the information in this chapter to help correct the problem If the problem is not covered here contact SonoSite technical support at the following numbers or addresses Technical Support USA Canada Technical Support fax Technical Support e mail SonoSite website International Technical Support European Service Center Japan Service Center Table 6 1 Troubleshooting Symptom 1 877 657 8118 1 425 951 6700 service sonosite com www sonosite com and select Support Contact your local representative or call USA 425 951 1330 44 0 1462 444 800 e mail uk service sonosite com 81 3 5304 5337 e mail service jp sonosite com Solution System will not power on System image quality is poor No CPD image No Color image No OB measurement selections Print does not work DVD VCR does not record
87. ss inverter 3 P02173 Wire harness display 4 P05410 Cover screw 5 P04529 Label bezel 6 P04163 Display bezel 7 P04156 Display LCD Appendix A Parts List 75 76 Table A 1 Display Continued Find Number Part Number Description Not shown P02489 P04098 P04345 P04499 P04501 P05381 Appendix A Parts List Clip display harness Enclosure back Display label 3D Gasket display Gasket display front Assembly backlight inverter E Sono ite Control Panel E e Far e Gain e C Table A 2 Control Panel Part Number Description P05462 Service Assembly Control Panel MicroMaxx English P05465 Service Assembly Control Panel MicroMaxx French P05466 Service Assembly Control Panel MicroMaxx German P05467 Service Assembly Control Panel MicroMaxx Italian P05468 Service Assembly Control Panel MicroMaxx Spanish P05469 Service Assembly Control Panel MicroMaxx Portuguese Appendix A Parts List 77 Replacement Parts System Table A 3 System Find Number Part Number Description 1 P05471 Service Assembly Power Supply MicroMaxx 2 P03872 Service Assembly Speaker MicroMaxx 3 P05470 Service Assembly TGC MicroMaxx 4 P05474 Service Assembly Upper Enclosure MicroMaxx Figure A 6 on P03874 Service Assembly Lower Enclosure MicroMaxx page 82 Note This part requires printing a replacement label for the product Contact SonoSite Technical
88. sseeecssseessseeenee 52 System Repair sss 22 Test Equipment 293 Failure Assert Codes 453 Verifying a System Assert Code eterne 53 Troubleshooting Flow Diagrams eese teennttennnttnnnntennntnn 54 Display eitis Control Panel System F ord pao m M Chapter 7 Replacement Procedures Display Replacement ssssiesssssssassssossassssacioncssssbuvsssodscssessssassssdanssssabiasdsecdeassstavanasssatevenes 59 R uiredi Parts sicscsscesssteccidisenstucscsussidcacssssavesstsissvazactesecebuseatardtscasceiussedtaaennatieasiioey 59 Required Tools iteration etit etis aiana iii 59 Display Removal 459 Display Replacement 61 Test the Display sss 62 Control Panel Subassembly Replacement ee 62 REQUIFEG PANS mere I 62 Required Tools 62 Control Panel Removal 62 Control Panel Replacement essere 62 Main System Disassembly for Repair and or Replacement 63 ize UEC In 63 Reg ired fero 63 Main PCBA Removal sssscsssssccssssssssscrsseecssscssseessssscnsseesssssensssessneecesnsensuseeese 63 BSonoSite Chapter 8 Performance Testing lu 69 E d
89. teries Do not use or charge the battery with non SonoSite equipment Only charge the battery with the system Chapter 2 Safety 7 Biological Safety Observe the following precautions related to biological safety WARNING Non medical commercial grade peripheral monitors have not been verified or validated by SonoSite as being suitable for diagnosis Do not use the system if it exhibits erratic or inconsistent behavior Discontinuities in the scanning sequence are indicative of a hardware failure that must be corrected before use Do not use the system if it exhibits artifacts on the LCD screen either within the clinical image or in the area outside of the clinical image Artifacts are indicative of hardware and or software errors that must be corrected before use Some transducer sheaths contain natural rubber latex and talc which can cause allergic reactions in some individuals Refer to 21 CFR 801 437 User labeling for devices that contain natural rubber Perform ultrasound procedures prudently Use the ALARA as low as reasonably achievable principle and follow the prudent use information concerning MI and TI SonoSite does not currently recommend a specific brand of acoustic standoff If an acoustic standoff is used it must have a minimum attentuation of 3dB cm MHz Some SonoSite transducers are approved for intraoperative applications if a market cleared sheath is used Labeling Symbols Labeling symbols for
90. this product should follow the prescribed standards for their area If visual inspection suggests possible contamination when opening a product returned for service take proper steps to contain the contamination Wear necessary Personal Protective Equipment PPE gloves masks and gowns when opening or examining a suspect package Before transfer to a service area label the suspect package contaminated and seal it to prevent exposure Discard any packing materials removed from a package suspected of contamination in a biohazard container Discard any contaminated materials received with the product in an appropriate biohazard container Contaminated materials may include biohazardous waste and sharps Maintain a disinfecting agent in case any work surface is contaminated The recommended agent is 0 596 sodium hypochlorite bleach solution To prepare the agent mix one part household bleach 5 2596 696 sodium hypochlorite to nine parts water Spray or wipe the solution onto the work surface and allow to air dry Please use these recommendations when cleaning or disinfecting your ultrasound system transducers and accessories This chapter assists in effective cleaning and disinfection but it is also intended to protect the system and transducers against damage during cleaning or disinfection For more information about cleaning or disinfecting solutions or ultrasound gels for the transducer call SonoSite technical support or your local repre
91. tion collected stored reviewed and transmitted on the system Administrator Login User Login On To access administrative settings enter your administrator user name and password and then click Login Nw R Delete Name Administrator User Information Login J Password R Confirm To reset your password contact SonoSite at 1 877 657 8118 F Password changes Save Cancel Figure 5 Setup Screens Administration and Administrator Information Administrator Login Press the Setup key Select Administration In Administrator Login type Administrator in the Name field Call SonoSite for the password 1 877 657 8118 Select Login Un AUN Change Administrator In User Information enter your new password in the Password field Password 2 Enterthe password again in the Confirm field To ensure passwords are secure it is recommended that passwords contain characters from the following categories Uppercase characters A Z Lower case characters a z Numbers 0 9 Note The password is case sensitive 3 In Password changes click on the check box to allow users access to change their password or leave unchecked to restrict access Optional 4 Select Save Chapter 4 Setup and Operation SonoSite User Login Setting 1 User Setup In the User Login list select On or Off Selecting On restricts access to the system and requires the user to enter a user name and password Select
92. turn settings for this setup page to factory default 28 Chapter 4 Setup and Operation SonoSite Connectivity IMT Calculations OB Calculations OB Custom Meas Connectivity MicroMAXX Ethernet Location Printer None E Host Name MicroMAXH Video mode NTSC maddes J Subnet Mask 255 255 0 0 Serial Port None oO 1 31 1 Transfer Mode SteLink E Aternate Gateway Ethernet Setup j Network Speed 10Mb Half Duple Save Cancel J Figure 10 Setup Screens Connectivity and Ethernet Printer 1 Press the Setup key 2 Select Connectivity 3 Inthe Printer list select the desired printer from the list of recommended printers Video Mode 1 Press the Setup key 2 Select Connectivity 3 Inthe Video mode list select NTSC or PAL for the desired mini dock video output Serial Port 1 Press the Setup key 2 Select Connectivity 3 Inthe Serial Port list select VCR DVD or Computer PC 4 Restart the system to activate VCR or DVD connectivity 5 Attach a serial cable RS 232 to the serial port from the mini dock MDS to the VCR DVD or PC Note If PC is selected the system allows report data to be sent as ASCII text from the system to a PC Special third party software must be on the PC to acquire view or format the data into a report Check the compatibility of your software with SonoSite technical support Transfer Mode 1 Press the Setup key 2 Select Connectivity 3 Inthe Transfer
93. two receive channels to allow detection of flow direction These two channels are then analyzed by a fast complex Fourier transform FFT circuit to establish the spectrum of frequencies present in the echoes The data are displayed as spectrum frequencies with respect to time PW can be used alone but is normally used in conjunction with a 2D image for spatial reference The 2D image has a graphical line D line superimposed on the 2D image indicating where the M mode beam is located The sample volume position depth and size are also indicated on the D Line The Doppler functional processing platform is in Figure 3 2 Chapter 3 System Overview SonoSite DIS Peak amp T mean gt ae e d Back End Temporal Baseline Display Averaging c Compress shift gt interpolate wA 128 samples 128 192 256 384 50 100 200 Hz L samples per line QBP WAF RES FFT MAG ap ERE fee LL tam PREI Resampe gt Window e Fer Lee RF PW or Quadrature 128 tap FIR 5 IQ pairs 5 ras basband input CW Audio Output Hilbert phase Audio shifter gain ea T gt Indicates IQ pairs B 2x16 bits PRF rate a Audio 5 Delay gt dan Figure 3 2 Doppler Processing Block Diagram The Doppler processing platform can be partitioned into eight 8 blocks
94. ubnet mask and Gateway IP address If Ping is OK 2 Using Verify check to see if device is available If Verify fails a Check the Printer Archiver s Port configuration on the MicroMaxx b Ensure that the Printer is online and the Archiver s application is running Verify that the Archiver supports the selected Capture Type setting E g US Image SC Image or US Ret Image Verify that the Printer supports the selected Image settings E g Color RGB or Grayscale Monochrome Verify that MicroMaxx AE Title or IP address has been correctly configured on the Printer Archiver Note Some devices require that the Imaging modality MicroMaxx be recognized in order to accept images This requires configuration on the device Check MicroMaxx Printer DICOM settings for correctness e g film size format etc E Sono ite Chapter 7 Replacement Procedures Display Replacement Note Consult Chapter 6 Troubleshooting before making any repairs Required Parts Service Assembly Display MicroMaxx P05463 Required Tools 1 Phillips screwdriver Torque screwdriver 2 0 10 0 inch pounds 0 23 1 1 newton meter 8 mm nut driver An anti static mat A wrist grounding strap 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 Display Removal Display 1 Remove the battery fr
95. umber 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 system Ref Number the reference number from the part number label of the failed system Serial Number the serial number from the part number label of the failed system Lot Number if applicable the Lot Number from the device 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 Typically found on the system information screen as MODES Event Description e A description of the problem from the viewpoint 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 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 part suspect part to be replaced Part Number the part number from the failed part suspect part itself Serial Number the serial number from the failed part suspect part itself Lot Number the lot number if available Rev the revision from the failed part suspect part itself if available Replaced By the person replacing the part Parts Installed e Th
96. yed properly Printer Test Printer Print two images in rapid succession and verify proper operation Operation 2 Verify that the print control on the system functions correctly Battery Charging Test Battery 1 Remove the system from the Docking System and insert a battery into the system Charging 2 Pressthe Power key to turn the system on Allow the battery to discharge The battery Operation indicator icon on the display below the Transducer Type indicator will extinguish from left to right as the battery discharges Note The battery may take 1 2 hours to discharge 3 Reattach the system to the Docking System and attach the AC power cord to the power connector 4 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 5 If charging is not evident see Chapter 6 Troubleshooting for troubleshooting procedures Chapter 8 Performance Testing 73 Video Output Caution Use only the recommended video monitor printer or VCR when verifying the video output at the video receptacle Test Video 1 Attach an external video monitor to the video connector using the video cable Output 2 Turnon 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 6 Tr

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