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Chapter 3:

 Safety

25

IEC 60601-2-37:2015 Medical Electrical Equipment - Part 2-37: Particular requirements for the basic safety 
and essential performance of ultrasonic medical diagnostic and monitoring equipment (Edition 2.1)

IEC 60601-1-6:2013 Medical Electrical Equipment Part 1-6: General requirements for basic safety and 
essential performance - Collateral Standard: Usability (Edition 3.1)

EMC standards classification

IEC 60601-1-2:2014, Medical Electrical Equipment, General Requirements for Basic Safety and Essential 
Performance-Collateral Standard. Electromagnetic Compatibility. Requirements and Tests.

CISPR 11:2009, Industrial, Scientific, and Medical (ISM) Radio-Frequency Equipment Electromagnetic 
Disturbance Characteristics—Limits and Methods of Measurement.

The Classification for the ultrasound system, docking system, accessories, and peripherals when 
configured together: Group 1, Class A.

DICOM standard

Digital Imaging and Communications in Medicine (DICOM), Version 3.1, 2007 (NEMA).
The system conforms to the DICOM standard as specified in the Sonosite PX DICOM Conformance
Statement, available at 

www.sonosite.com

. This statement provides information about the purpose, 

characteristics, configuration, and specifications of the network connections supported by the system.

Security and privacy standards

The system includes security settings that help you to meet the applicable security requirements listed in
the HIPAA standard. Users are ultimately responsible for ensuring the security and protection of all 
electronic protected health information collected, stored, reviewed, and transmitted on the system.

HIPAA:1996, 45 CFR Parts 160 and 164; Subparts A, C, and E, Health Insurance Portability
and Accountability Act (HIPAA) Privacy and Security Rules

NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and
Organizations

Security and privacy

• The port for DICOM communication (specified by the user in the system settings; typically port 104, 

2762,or 11112) is used for outgoing communication to the network.

• Anti-virus software is not installed on this device.
• This device has a single configurable listening port for the purposes of DICOM Echo and Storage 

Commitment.

• The security and privacy-related configurable controls in Sonosite PX are:

• User roles and responsibilities
• Automatic user log off
• User authorization and authentication
• Data backup and recovery
• Data encryption (at rest and in transit)

• System and department administrators should follow the suggested technical and physical safeguards 

listed below, as well as the detailed HIPAA guidelines to ensure HIPAA compliance:

•

Room Access Control: 

Local procedures must be put in place to limit physical access to medical 

equipment, to prevent accidental, casual, or deliberate contact by unauthorized individuals.

•

System Access Controls: 

Access the system only through unique user accounts. Login 

credentials must not be disclosed.

Содержание Sonosite PX System

Страница 1: ...i Sonosite PX Ultrasound System Service Manual ...

Страница 2: ...ii ...

Страница 3: ...poration DICOM is the registered trademark of the National Electrical Manufacturers Association All other trademarks are the property of their respective owners Patents US 9 895 133 US 9 848 851 US 9 671 491 US 9 420 998 US 9 151 832 US 8 876 719 US 8 861 822 US 8 568 319 US 8 500 647 US 8 398 408 US 8 213 467 US 8 088 071 US 8 066 642 US D625 015 US D625 014 US 7 740 586 US 7 591 786 US 6 962 566...

Страница 4: ...iv ...

Страница 5: ...tatic discharge 20 Separation distance 20 Manufacturer s declaration 20 Essential performance requirements 24 Standards 24 Electrical safety standards 24 EMC standards classification 25 DICOM standard 25 Security and privacy standards 25 Security and privacy 25 Managing users on the system 26 Configuring a connection to a directory server 26 To configure the connection to a directory server 26 Sys...

Страница 6: ...ver 48 User Interface Replacement 48 Required Parts 48 Remove User Interface 48 Install User Interface 51 Clinical Display Replacement 51 Required Parts 51 Remove Clinical Display 51 Install Clinical Display 54 Main System Disassembly for Repair and or Replacement 55 Required Tools 55 System Disassembly 55 Speaker Replacement 55 Required Parts 55 Remove Speaker 55 Install Speaker 57 USB Aux Board ...

Страница 7: ...placement 67 Required Part 67 Remove Interposer Assembly 67 Install Interposer Assembly 67 Fan Replacement 67 Required Parts 67 Other Parts As Required 67 Remove Fan 67 Install Fan 67 Stand Head Replacement 68 Remove Stand Head 68 Install Stand Head 68 Optional Equipment Stand System 69 Sony UP X898MD Printer 69 Required Part 69 Required Tools 69 Remove Printer 69 Install Printer 70 Maintenance 73...

Страница 8: ...eplacement Parts 83 Clinical Monitor 84 User Interface 85 Persistent Controls 86 Main PCBA 87 ComE 88 Power Supply PCBA 89 Power In Aux Board PCBA 90 Power Button With ECG PCBA 90 USB Aux Board PCBA 91 SHIF PCBA 91 System Dock PCBA 92 Optional Equipment 92 Sony UP X898MD B W Printer 92 Ordering Replacement Parts 93 Service Event Reporting 95 Service Event Report Form 96 Service Event Report Instru...

Страница 9: ...all Fujifilm Sonosite at 888 482 9449 in the U S Outside the U S call the nearest Fujifilm Sonosite representative For technical support please contact Fujifilm Sonosite as follows Fujifilm Sonosite Technical Support Phone U S or Canada 877 657 8118 Phone Outside U S and Canada 425 951 1330 Or call your local representative Fax 425 951 6700 E mail ffss service fujifilm com Web site www sonosite co...

Страница 10: ...42 EEC Class 1 device requiring verification by the Notified Body of sterilization or measurement features or to a Class IIa IIb or III device requiring verification or auditing by the Notified Body to applicable Annex es of 93 42 EEC Attention see the user guide Refer to instruction manual for use Consult instructions for use Medical Device Device complies with relevant Australian and New Zealand...

Страница 11: ...006 66 EC for Batteries WEEE Corrugated recycle Dangerous voltage Date of manufacture Manufacturer Direct Current DC Do not get wet Do not stack over n high where n represents the number on the label Electrostatic sensitive devices Device complies with relevant FCC regulations for electronic devices Fragile GEL Gel Sterilized using irradiation Sterilized using ethylene oxide Table 1 Labeling Symbo...

Страница 12: ... against solid foreign objects Handle transducer with care Follow manufacturer s instructions for disinfecting time Disinfect transducer Type BF patient applied part B body F floating applied part Defibrillator proof type CF patient applied part Potential equalization terminal Pollution Control Logo Applies to all parts products listed in the China RoHS disclosure table May not appear on the exter...

Страница 13: ...eople s Republic of China European community authorized representative Maximum weight load Indicates total weight of the equipment including the safe working load WARNING Connect Only Accessories and Peripherals Recommended by Sonosite WARNING Connect Only Accessories and Peripherals Recommended by Fujifilm Sonosite Table 1 Labeling Symbols Continued Symbol Definition ...

Страница 14: ...6 Chapter 1 Introduction ...

Страница 15: ...55 9 cm Width 20 25 in 51 4 cm Height 45 in 114 3 cm maximum 33 in 83 8 cm minimum Height range 9 84 in 25 cm Weight 40 0 lbs 18 1 kg Storage bin capacity 11 lbs 5 kg Total stand weight with system and peripherals 101 lbs 46 kg maximum Touch Panel Projected Capacitive PCAP Display Type Diagonal 11 6 in 29 46 cm Multi touch Gestures for System Controls Display Diagonal 15 6 in 39 62 cm Length 13 55...

Страница 16: ...ge System and Transducer 35 65 C 31 149 F 15 95 R H 500 to 1060hPa 0 5 to 1 05 ATM Battery Operating 0 40 C 32 104 F 15 95 R H 700 to 1060hPa 0 7 to 1 05 ATM Shipping and Storage 20 60 C 4 140 F For storage longer than 30 days store at or below room temperature 15 95 R H 500hPa to 1060hPa 0 5 to 1 05 ATM Battery specifications The Sonosite PX system uses two lithium ion batteries that are charged ...

Страница 17: ...art Number Maximum Cable Length C5 1 transducer P08010 5 5 ft 1 7 m IC10 3 transducer P07678 5 7 ft 1 7 m L12 3 transducer P21070 5 5 ft 1 7 m L15 4 transducer P21636 7 5 ft 2 3 m L19 5 transducer P21015 7 5 ft 2 3 m P5 1 transducer armored P21556 6 0 ft 1 8 m Batteries 2 P27852 Ethernet cable NA 49 2 ft 15 m Black white printer P20006 Stand P25002 Stand Head P25001 Stand AC power cord P00848 10 f...

Страница 18: ...10 Chapter 2 Specifications ...

Страница 19: ...void the risk of electrical shock or injury do not open the system enclosures All internal adjustments and replacements including battery replacement must be made by a qualified technician WARNING 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 be achieved only when equipment is co...

Страница 20: ...by Fujifilm Sonosite WARNING To prevent injury to the operator bystander the transducer must be removed from patient contact before the application of a high voltage defibrillation pulse WARNING Because the only method of completely removing AC power from the stand is to disconnect the AC input power cord from the stand base ensure that you place the stand in a location in which you can easily rem...

Страница 21: ...ipment when powered from internal battery packs not connected to AC power Type BF applied parts Ultrasound transducers Ingress Protection IPX0 Ultrasound system on the stand Ingress protection IP22 Ultrasound system off the stand IPX 7 watertight equipment Ultrasound transducers Non AP APG Ultrasound system including power supply stand elements and connected peripherals is not suitable for use in ...

Страница 22: ...es over 60 C 140 F Keep it away from fire and other heat sources WARNING Do not charge the battery near a heat source such as a fire or heater WARNING Do not leave the battery in direct sunlight WARNING Do not pierce the battery with a sharp object hit it or step on it WARNING Do not use a damaged battery WARNING Do not solder a battery WARNING The polarity of the battery terminals is fixed and ca...

Страница 23: ...it and stop using it If you have any questions about the battery consult Fujifilm Sonosite or your local representative Periodically check to make sure that the battery charges fully If the battery fails to charge fully replace it Use only Fujifilm Sonosite batteries Do not use or charge the battery with non Sonosite equipment Only charge the battery with the system ...

Страница 24: ...eing prepared to treat allergic reactions promptly WARNING Perform ultrasound procedures prudently Use the ALARA as low as reasonably achievable principle and follow the prudent use information concerning MI and TI WARNING Fujifilm Sonosite does not currently recommend a specific brand of acoustic standoff If an acoustic standoff is used it must have a minimum attenuation of 3dB cm MHz WARNING Use...

Страница 25: ...rgical equipment or in a RF shielded room where magnetic resonance imaging is performed because both produce high electromagnetic disturbances which could result in performance disruption of the ultrasound system These limits are designed to provide reasonable protection against harmful interference in a typical medical installation WARNING Products and accessories may contain hazardous materials ...

Страница 26: ... s Turn equipment in the vicinity off and on to isolate disruptive equipment Relocate or re orient interfering equipment Increase distance between interfering equipment and your ultrasound system Connect the ultrasound equipment and the interfering equipment or equipment being interfered with to different power outlet circuits Manage use of frequencies close to ultrasound system frequencies Remove...

Страница 27: ... at 17 dBm 2 dBm MCS 0 IEEE 802 11b with Direct Sequence Spread Spectrum DSSS at 15 dBm 2 dBm 11 Mbps IEEE 802 11g with Orthogonal Frequency Division Multiplexing OFDM at 14 dBm 2 dBm 54 Mbps IEEE 802 11n with Orthogonal Frequency Division Multiplexing OFDM at 18 dBm 2 dBm MCS 0 Note This device is in compliance with the essential requirements and other relevant provisions of Directive 1999 5 EC t...

Страница 28: ...pment could result The Sonosite PX ultrasound system is intended for use in an electromagnetic environment in which radiated radio frequency RF disturbances are controlled The customer or the user of the Sonosite PX ultrasound system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Sonosite ...

Страница 29: ...monic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Guidance and Manufacturer s Declaration Electromagnetic Immunity per IEC 60601 1 1 2 2014 The Sonosite PX ultrasound system is intended for use in the electromagnetic environment specified below Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Electrostatic Discharge E...

Страница 30: ...tion the Fujfilm Sonosite ultrasound system further from sources of power frequency magnetic fields or to install magnetic shielding The power frequency magnetic field should be measured in the Intended installation location to assure that it is sufficiently low Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 6Vrms in ISM bands 3 Vrms 6 Vrms in ISM bands Portable and mobile RF communications e...

Страница 31: ...ed with the following symbol IEC 60417 No 417 IEC 5140 Source of non ionizing radiation Proximity fields from wireless communicatio ns equipment IEC 61000 4 3 Per 60601 1 2 2014 Table 9 Per 60601 1 2 2014 Table 9 UT is the AC mains voltage prior to application of the test level At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic...

Страница 32: ...ion If this equipment does cause harmful interference to other medical or electronic equipment take suitable precautions as detailed on page 12 Standards Electrical safety standards ANSI AAMI ES60601 1 2005 R 2012 and A 1 2012 Medical electrical equipment Part 1 General requirements for basic safety and essential performance Edition 3 1 CAN CSA C22 2 No 60601 1 2014 Medical electrical equipment Pa...

Страница 33: ...you to meet the applicable security requirements listed in the HIPAA standard Users are ultimately responsible for ensuring the security and protection of all electronic protected health information collected stored reviewed and transmitted on the system HIPAA 1996 45 CFR Parts 160 and 164 Subparts A C and E Health Insurance Portability and Accountability Act HIPAA Privacy and Security Rules NIST ...

Страница 34: ... device Managing users on the system Only administrators can manage user accounts including importing user accounts from another system creating or editing a user account or deleting user accounts from the system To manage users by synchronizing with a directory server and using server based user accounts see Configuring a connection to a directory server below Requiredfieldsare indicated by an as...

Страница 35: ...the Search root field type the path to the root directory 8 In the User DN field type the user domain name 9 In the Manager name field type the username of an account that has LDAP access 10 In the Manager password field type the password for the account that has LDAP access 11 When you ve finished configuring your connection tap Test Connection Note Iftheconnectionfails makesurethatyouhaveentered...

Страница 36: ...28 Chapter 3 Safety ...

Страница 37: ...d review printing and recording capabilities The system includes optional Digital Imaging and Communications DICOM capabilities as well as general computer communication capabilities to provide the acceptance transfer display storage and digital processing of ultrasound images and loops Security support is also provided to facilitate HIPAA compliance The system displays the current output level in...

Страница 38: ...ween 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 ...

Страница 39: ...ood 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 battery A high pass filter wall filter is used to remove the signals fro...

Страница 40: ...ned to produce an appropriate bandwidth For example in 2D grayscale imaging a wide band pulse is used to support good axial resolution For Doppler modes a narrower band pulse is used which improves the spectral resolution of the detected Doppler signal In addition to transmit pulse control programmable digital signal processing is used in the receive path to further refine the bandwidth used to pr...

Страница 41: ...ations The waveform is selected to drive the transducer at a certain center frequency bandwidth and power and is optimized for the given mode The receive section consists of a transmit receive switch to protect the receiver from the transmit voltage a variable gain receiver to amplify and condition the return echoes an A Dconverter to digitize the data a delay block to focus the return signals and...

Страница 42: ...shows the high level architecture of the system with the portable system highlighted in blue Please refer to Figure 4 3 on page 34 Optional components are shown with dashed lines The AC DC Power Supply may be connected in one of two places directly to the Portable System when not docked in the Stand Head or through the Stand Head via an AC DC Power Supply located in the stand base Figure 4 3 Sonos...

Страница 43: ...witches Analog Front End AFE chips TGC DAC CW components and analog power conditioning The Scanhead Interface SHIF connector resides on a separate PCB with a high density connector connecting the Main PCBA to the SHIF board All 128 element signals from the SHIF connector are connected to sixteen transmitters containing eight three level transmit channels each The transmitters also contain eight T ...

Страница 44: ...ill control adjust and monitor the power supply rails required for the system low voltage power supplies are fed to the Main PCBAs analog and digital sections The high voltage power supplies are for the Main PCBA analog section to drive the transmit receive circuits as well as a connected transducer or TTC through the SHIF connector Dock Interface PCBA The Dock Interface PCBA has connections to th...

Страница 45: ...r input Persistent Controls The customizable touch UI is augmented with a series of persistent controls for high use functions e g power freeze gain with the goal of providing users with controls they can find and activate without visualizing the control surface These controls consist of discrete buttons a touchpad and a touch activated rotational control Power Supply and Control The Sonosite PX u...

Страница 46: ...38 Chapter 4 System Overview ...

Страница 47: ...istrative settings page 2 Tap Admin Settings 3 Tap Delete all patient data for the ePHI reset or the Factory Reset button for Full Factory Reset 4 Make sure the system is connected to AC power and tap Yes to continue The process will take approximately 35 minutes Note If you are not connected to AC power and the batteries die you will need to restart the process 5 When the wipe is complete tap OK ...

Страница 48: ... board level components by unauthorized entities voids the Fujifilm Sonosite warranty Test Equipment Test equipment is not required for this troubleshooting section Assert Failure Codes The Sonosite PX system is capable of displaying an assert screen call for help instructing the user to contact Sonosite Technical Support for hardware and software issues related to failures PCB failures typically ...

Страница 49: ...fied here C xxxxx D x Record the following information and report these values to Fujifilm Sonosite Technical Support User Interface Clinical Display Assert Cause 1 Record the assert code 2 Press and release the Power button on the User Interface to power the system down 3 Press the Power button to power on the system If the system powers on normally it has likely recovered from the fault software...

Страница 50: ...ng Socket communication failed TSOCKET_CONNECT_FAIL URE Invalid network configuration Wrong port number Application is not running Printer is offline Using Ping verify that the Printer Archiver is connected If Ping fails check the device s IP address Sonosite PX IP address Subnet mask and Gateway IP address If Ping is OK use Verify to check if device is available If Verify fails a Check the Printe...

Страница 51: ...Attribute Check Sonosite PX Printer DICOM settings for correctness e g film size format Table 5 3 DICOM Troubleshooting Continued Error Message Tiller Error Code Possible Cause Troubleshooting Problem Cause Troubleshooting No Display Faulty display or Main PCBA Feed video to an external monitor from the HDMI port on the Stand Head If the video is not present on the external display the Main PCBA i...

Страница 52: ...d to AC batteries up to 50 one long flash followed by 2 short flashes same Connected to AC batteries up to 75 one long flash followed by 3 short flashes same No AC operation on battery power OFF same Problem Cause Troubleshooting Will not power on Battery Issue Remove batteries Inspect batteries and battery compartment contacts for damage corrosion Install batteries and try again Remove batteries ...

Страница 53: ... If one or more buttons fail to operate or if the touchpad does not function replace the Persistent Controls Problem Troubleshooting No Power Check for the green AC led on the base of the Stand If it is on AC is present and the External Power Supply is providing power Check for the green led on the Stand Head where the DC power enters If it is lit power is present If issue still exists and a Deskt...

Страница 54: ...46 Chapter 5 Troubleshooting ...

Страница 55: ...ould be fully tested in accordance with Chapter 8 Required Tools Torx bits T6 T8 T10 T20 and T30 Torque screwdriver 1 0 10 0 inch pounds 0 23 1 1 Newton meter Torque screwdriver 10 0 25 0 inch pounds 1 1 2 8 Newton meter Small flat head screwdriver 2 Phillips screwdriver Anti Static mat Wrist grounding strap Remove Batteries Remove the batteries and disconnect DC power before servicing the Sonosit...

Страница 56: ...ormed Patient Data Drive Removal 1 Remove the Left Enclosure Pocket cover from the left front side of the system as shown in Figure 6 2 on page 48 2 Use a T10 bit to remove two screws from the Encrypted Memory Enclosure cover and remove 3 Remove the Patient Data Drive with tweezers or small needle nose pliers Install Patient Data Drive Cover 1 Place the Encrypted Memory Enclosure over the opening ...

Страница 57: ...49 Figure 6 3 System Bottom View Figure 6 4 System Top View 4 Remove the Front Panel Enclosure by lifting slightly on the front edge of the user interface The Front Panel Enclosure will come out easily Refer to Figure 6 5 on page 50 H ...

Страница 58: ...k the tabs on the UI Begin by lifting straight up until the tabs clear the enclosure 6 Once the tabs are clear the rear of the UI may be placed on the Bottom Enclosure and the front lifted up to access the interconnection cables 7 Remove the UI to Main PCBA Cable and Persistent Control to Main Flex Cable from the Main PCBA 8 Remove the UI from the system Figure 6 6 User Interface Removal UI Pin Up...

Страница 59: ...stall the batteries per Figure on page 48 Clinical Display Replacement Required Parts P24504 XX Service Assembly Clinical Display Sonosite PX Remove Clinical Display 1 Remove the User Interface as shown above 2 Place the system upright with the back facing toward you Remove the WiFi Dongle by pressing on the right side to release Refer to Figure 6 7 on page 51 3 Disconnect the USB cable from the W...

Страница 60: ...Clinical Display Cable from the Main PCBA per Figure 6 10 on page 53 10 Move the Clinical Display to the lowered or closed position 11 Use a T20 bit to remove the 2 screws in each hinge per Figure 6 10 on page 53 12 Carefully lift the Clinical Display and feed the Clinical Display Cable through the Bottom Enclosure to complete the removal Caution The following steps remove the Hinge Tubes The disp...

Страница 61: ...6 Replacement Procedures 53 Figure 6 9 Rear EMI Shields Figure 6 10 Clinical Display Removal Display Cable and EMI shield Wifi Dongle cable and EMI Shield Clinical Display Cable Remove 2 screws from each hinge ...

Страница 62: ...screws in each hinge with a T20 bit and tighten to 5 5 inch pounds 6 Connect the Clinical Display Cable to the Main PCBA J3002 per Figure 6 10 on page 53 7 Put Display Cable EMI Shield in place and secure the two screws with a T6 bit Tighten to 2 0 inch pounds 8 Feed the Wireless Dongle USB Cable through the Rear Enclosure and snap Rear Enclosure in place per Figure 6 8 on page 52 9 Remove tape ho...

Страница 63: ...stem Disassembly 1 Remove the User Interface 2 Remove the Clinical Display 3 The Base Assembly replaceable parts are now exposed per Figure 6 12 on page 56 Speaker Replacement Required Parts P26357 Speaker P26388 Speaker Gasket Note A small amount of RTV664 will be needed to secure the speaker to the speaker housing Remove Speaker 1 Disconnect the speaker wire from the Main PCBA shown in Figure 6 ...

Страница 64: ...Aux Board SHIF PCBA wire bundle Rear Large fan bank Front Small fan bank Patient data drive location Main PCBA Not shown Power Supply PCBA Dock Interface PCBA and Scanhead Interface SHIF PCBA ComE PCBA Left Speaker Wire Right Speaker Wire Insert screwdriver through speaker wire hole in Bottom Enclosure and press against speaker to dislodge ...

Страница 65: ... Figure 6 14 Speaker Installation USB Aux Board Replacement Required Part P24915 XX Service Assembly USB AUX Board PCBA Sonosite PX Remove USB Aux Board 1 Disconnect USB Aux Board from Main PCBA per Figure 6 15 on page 58 2 Use a T10 bit to remove the two screws securing the USB Aux Board 3 Remove the USB Aux Board from the system Install USB AUX Board 1 Place USB Aux Board in the system 2 Use a T...

Страница 66: ...ower Button with ECG PCBA 1 Remove screw from the ECG Flex Interconnect Cable using a T8 bit per Figure 6 16 on page 58 2 Disconnect the ECG Flex Interconnect Cable from the Main PCBA and Power Button with ECG PCBA and remove 3 Remove two screws from the Power Button with ECG PCBA and remove Figure 6 16 Power Button with ECG PCBA Remove screws Disconnect from Main PCBA Screw T8 Screws T8 ...

Страница 67: ... Aux Board PCBA Sonosite PX Remove Power In Aux Board PCBA 1 Remove the ECG Flex Interconnect Cable from the system as shown in previous section per Figure 6 16 on page 58 This will ensure the easiest access to the item being removed 2 Use the Power In Tool to remove the plastic cap on the Power In connector per Figure 6 17 on page 59 3 Use the Power In Tool to remove the Power In nut from the Pow...

Страница 68: ...Power Supply PCBA Their removal will be a part of this process For the following steps reference Figure 6 19 on page 61 1 Disconnect Left and Right Speaker connections 2 Disconnect 10 Fan connections 3 Remove the ECG Flex Interconnect Cable 4 Disconnect the USB Aux Cable 5 Disconnect the WiFi Dongle USB cable if present 6 Disconnect the AB cable 7 Disconnect the 5 SHIF Assembly Cables 8 Remove the...

Страница 69: ...then follow the steps for the specific item only Power Supply PCBA Replacement Required Part P24174 XX Service Assembly Power Supply PCBA Remove Power Supply PCBA 1 Use a T10 bit to Remove the 7 screws securing the Power Supply PCBA to the Main PCBA per Figure 6 20 on page 62 2 Gently lift the Power Supply PCBA using a slight rocking motion to release the connections Dockto Main Board Cable Left S...

Страница 70: ...Place Power Supply PCBA onto Main PCBA Make sure connectors are aligned and press into place per Figure 6 21 on page 62 2 Use a T10 bit to install 7 screws and tighten to 5 5 inch pounds Figure 6 21 Power Supply PCBA Install ComE PCBA Replacement Remove 7 Screws Ensure connectors align properly ...

Страница 71: ...ntly lift the ComE PCBA using a slight rocking motion to release the connections Figure 6 22 ComE PCBA removal Install ComE PCBA 1 Place ComE PCBA onto Main PCBA Make sure connectors are aligned and press into place per Figure 6 23 on page 63 2 Use a T8 bit to install 4 screws and tighten to 5 5 inch pounds Figure 6 23 Install ComE PCBA Remove 4 screws Ensure connectors align properly ...

Страница 72: ...t screw does not include the spring clip 3 Install the SHIF to Main Board Power Cable Reference Figure 6 19 on page 61 for this and following connections 4 Install the Docking to Main Board Cable 5 Install the 5 SHIF Assembly Cables The numbers on the cables will match to the Numbers on the Main PCBA 6 Connect the AB cable ensuring each cable matches the lettering on the Main PCBA Caution If the c...

Страница 73: ...tact and is flush with Dock PCBA If necessary wiggle the screws or board until they are flush Caution Do not force Alignment Pins in place Failure to align them correctly will lead to a damaged board 3 Use a T8 bit to install the 7 screws and tighten to 5 5 inch pounds 4 Use a T30 bit to tighten the Alignment Pins to 20 inch pounds 5 Install the Main PCBA 6 Install the Clinical Display 7 Install t...

Страница 74: ...SHIF PCBA 1 Position the system with the bottom facing up as shown 2 Feed SHIF PCBA cables through the Bottom Enclosure as shown and seat the SHIF PCBA in place 3 Install the Interposer Assembly with the cut outs facing as shown and align guide pins into holes 4 Use a T8 bit to install 4 screws and tighten to 5 5 inch pounds 5 Turn the system over with the top facing up 6 Use a T8 bit to install 2...

Страница 75: ...et 1 each 2 per fan Other Parts As Required P24959 Fan Gasket for 2 P24945 Fans 3 sets P24958 Fan Gasket for 4 P24944 Fans inner group P25688 Fan Gasket for 1 P24944 Fan outer group P27225 Fan Baffle Plate 1 each only required for 1 small fan mounted on the left front of the system Remove Fan 1 Cut the button on the outside end of the Fan Mount Rivet and pull the rivet through from the inside of t...

Страница 76: ...he column cover and remove It will still be connected to the power cable 4 Disconnect the USB cable in the column from the port inside the base of the Stand Head 5 Use a 4mm hex bit to loosen the two screws securing the Stand Head 6 Lift on the Stand Head to remove from the column Install Stand Head 1 Install the Stand Head by following the prior removal steps 1 5 in reverse order Cut leaving 3 se...

Страница 77: ...X898MD has to be replaced Required Part P20006 Sony UP X898MD B W Printer Required Tools 1 Phillips screwdriver 5mm hex bit with driver Remove Printer 1 Remove the rear cover on the printer exposing the USB and power cables per Figure 6 29 on page 70 2 Disconnect the USB and power cables from the rear of the printer 3 Use a 5mm hex bit to loosen the two screws under the printer 4 Lift the printer ...

Страница 78: ...70 Chapter 6 Replacement Procedures Install Printer 1 Install the Printer by following the prior removal steps 1 5 in reverse order Figure 6 29 Printer Replacement 1 2 3 4 5 ...

Страница 79: ...Chapter 6 Replacement Procedures 71 ...

Страница 80: ...72 Chapter 6 Replacement Procedures ...

Страница 81: ...hat require periodic testing calibration adjustment or alignment Performance tests are described in Chapter 8 Performance Testing of this manual Performing maintenance procedures not described in this manual may void the product warranty Local regulations may require electrical safety testing Contact Fujifilm Sonosite Technical Support for any maintenance questions See Contact Information on page ...

Страница 82: ...74 Chapter 7 Maintenance ...

Страница 83: ...equivalent Acoustic gel Setting Up Performance Tests 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 Set up Performance Tests 1 Attach the C5 1 transducer to the system...

Страница 84: ...ed there is a corresponding increase and decrease in echo intensity 6 Capture a Cineloop buffer Exercise the Cineloop controls and verify proper operation 7 Verify the airflow from the fan vents on the rear of the system flow outward Test 2D Performance and Image Quality 1 Use a C5 1 transducer in 2D mode 2 Adjust the position of the C5 1 transducer on the phantom 3 With the array pointing down an...

Страница 85: ...ement is complete when you finish moving the calipers Press the Select button to alternate the active caliper and adjust the measurement with the touchpad Test Axial Measurement Accuracy 1 Measure the distance center to center of any two pins that are 5 12 cm apart vertically 2 Verify that the distance measured is within the tolerance listed in Table 8 1 Set Up Lateral Measurement Accuracy Perform...

Страница 86: ... system settings as previous measurements if possible 2 Adjust the system controls to obtain a clear image that shows the limits of echo penetration 3 Press the Freeze button and then save the image 4 Measure from the center of the skinline to the deepest vertical position where the scatter echoes start to break up and tissue definition is lost 5 Record and retain the results for future reference ...

Страница 87: ...ver the image using the Touch Pad 4 Press the M Mode button 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 Save the image Slide the Freeze Unlock to return to live imaging 7 Press the 2D key to return to 2D imaging Test THI Imaging 1 Attach the C5 1 transduc...

Страница 88: ...utton again for the Doppler spectral trace 4 Place a large drop of ultrasound gel on the transducer lens 5 Adjust the Gain control as necessary and then gently tap the top of the gel and observe a reflection on the spectral trace and the sound from the speakers 6 Press the Freeze button and then save the image Press the Freeze button to return to live imaging 7 Press the 2D key to return to 2D ima...

Страница 89: ...res the Sony UP X898MD USB Black White Printer P20006 to be connected to the system under test Skip this test if a printer is not available Test Printer Operation 1 Press the print button and verify that the printer begins to print an image 2 Verify the proper content of the printed image ...

Страница 90: ...82 Chapter 8 Performance Testing ...

Страница 91: ...following tables contain all the field replaceable parts for the Sonosite PX ultrasound system Quantities are one unless otherwise noted Please refer to Figure A 1 on page 83 to identify the major components of the Sonosite PX Figure A 1 Sonosite PX Major Components ...

Страница 92: ...2 Clinical Monitor Display Table A 1 Clinical Monitor Display Part Number Description P24504 XX Service Assembly Display Sonosite PX Table A 2 Clinical Monitor Display Associated Hardware Part Number Quantity Description P16667 4 SCREW FLAT 6 LOBE M4 0 7X10MM ...

Страница 93: ...User Interface Part Number Description P24503 XX Service Assembly User Interface Sonosite PX P29064 XX Service Assembly User Interface Sonosite PX International Table A 4 User Interface Associated Hardware Part Number Quantity Description P24931 1 Main to Persistent Control Flex Cable ...

Страница 94: ... Controls Part Number Description P23160 XX Service Assembly Persistent Controls Assembly Sonosite PX P27041 XX Service Assembly Persistent Controls Assembly Sonosite PX International Table A 6 Persistent Controls Associated Hardware Part Number Quantity Description P25992 12 SCREW FLAT 6 LOBE M3 0 5X6MM ...

Страница 95: ...A Table A 8 Main PCBA Associated Hardware Table A 7 Main PCBA Part Number Description P26956 XX Service Assembly Main PCBA Sonosite PX Part Number Quantity Description P26599 4 Screw 6 Lobe M2 5 0 45x5MM P24968 4 Spring Clip P24967 4 Flat Washer P25716 4 Grommet ...

Страница 96: ...ComE Figure A 6 ComE Table A 10 ComE Associated Hardware Table A 9 ComE Part Number Description P27411 XX Service Assembly ComE I5 With Heat Spreader Sonosite PX Part Number Quantity Description P24945 4 SCREW PAN 6 LOBE M2 5 0 45X5MM ...

Страница 97: ...gure A 7 Power Supply PCBA Table A 11 Power Supply PCBA Table A 12 Power Supply PCBA Associated Hardware Part Number Description P24174 XX Service Assembly Power Supply Sonosite PX Part Number Quantity Description P25951 4 SCREW TRUSS 6 LOBE M3 0 5X18MM ...

Страница 98: ...r Button With ECG PCBA Table A 15 Power Button With ECG PCBA Table A 16 Power Button With ECG PCBA Associated Hardware Part Number Description P24915 XX Service Assembly Power in Aux Board PCBA Sonosite PX Part Number Quantity Description P27078 1 Power In plug gasket P27116 1 Power In Cap P25922 2 SCREW FLAT 6 LOBE M3 0 5X6MM Part Number Description P27479 XX Service Assembly Power Button With EC...

Страница 99: ...B Aux Board PCBA Associated Hardware SHIF PCBA Figure A 11 SHIF PCBA Part Number Quantity Description P25945 2 SCREW PAN 6 LOBE M2 5 0 45X5MM P25806 1 Flex Interconnect PCBA Part Number Description P24939 XX Service Assembly USB Aux Board PCBA Sonosite PX Part Number Quantity Description P25992 2 SCREW FLAT 6 LOBE M3 0 5X6MM ...

Страница 100: ...A 21 System Dock PCBA Associated Hardware Optional Equipment Sony UP X898MD B W Printer Figure A 13 Sony UP X898MD B W Printer Part Number Description P25394 XX SHIF PCBA Sonosite PX Part Number Description P25394 XX Service Assembly System Dock PCBA Sonosite PX Part Number Quantity Description P25945 7 SCREW PAN 6 LOBE M2 5 0 45X5MM ...

Страница 101: ...ujifilm Sonosite Technical Support as indicated in Contact Information on page 1 Table A 22 Sony UP X898MD B W Printer Hardware Part Number Description P20006 Sony UP X898MD B W Hybrid Graphic Printer P27276 Screw Hex M6 1 0X12MM Steel x4 P27577 Cable USB A to B P27599 Cable AC Power ...

Страница 102: ...94 Appendix A Replacement Parts ...

Страница 103: ...ice facilities which provide approved warranty services for Fujifilm Sonosite products For all repairs completed complete the form and email a copy of it to ffss service fujifilm com or mail to the following address Fujifilm Sonosite Inc Technical Support 21919 30th Drive SE Bothell Washington 98021 USA To contact Fujifilm Sonosite Technical Support see Contact Information on page 1 ...

Страница 104: ... a RMA for repair at SonoSite Service Provider Name Provider Reference Company Date Reported Address Phone Number Fax Number E mail address Device Description Ref Number Serial Number Name Lot Number ARM SHDB Version Configuration Problem Found Service Performed Performed By Date Parts Removed Part Name Part Number Serial Number Lot Number Rev Replace Parts Installed Part Name Part Number Serial N...

Страница 105: ...e Description x Name the description of the failed product x Ref Number the reference number from the part number label of the failed product x Serial Number the serial number from the part number label of the failed product x Lot Number if applicable the Lot Number from the device identification label x ARM SHDB Version the software level of the failed device Typically found on the system informa...

Страница 106: ...name Serial number Description of the problem Shipping Instructions Please contact Fujifilm Sonosite to get a return material authorization number RMA Contact Fujifilm Sonosite before returning any product The shipping address for all returned products is Fujifilm Sonosite Inc Attn Technical Support RMA ___________________ 21919 30th Drive SE Bothell Washington 98021 USA ...

Страница 107: ...eshooting 44 C cautions definition 2 Clinical safety 16 Contact Information 1 Create user account 26 D DICOM Troubleshooting 42 E electrical safety 11 specifications 7 Electrical Specifications 7 electromagnetic compatibility 17 equipment safety 13 error message 12 ESD 20 F Failure Reporting 95 Fan replacement 67 H humidity limits 8 I image quality verification test 80 review 81 L Labeling symbols...

Страница 108: ...orization number RMA 98 Returning Products 98 S safety electrical 11 electromagnetic compatibility 17 equipment 13 Security and privacy 25 Service Event Report 95 Shipping Instructions 98 shipping specifications 8 speakers 55 Stand Head replacement 68 storage specifications equipment 8 system measurement accuracy 77 overview 29 System and Subsystem Diagnosis 40 System Specifications 7 T temperatur...

Страница 109: ...101 ...

Страница 110: ...102 P25393 01 P25393 01 ...

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