BK Medical bk5000 User Manual
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BK Medical bk5000 User Manual

Ultrasound systems
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User Guide
bk3000 & bk5000 Ultrasound Systems
16-01249-EN-08
March 2019
For Professional Users Only

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  • Page 1 User Guide bk3000 & bk5000 Ultrasound Systems 16-01249-EN-08 March 2019 For Professional Users Only...
  • Page 2 Any modification of or installation of software without written permission from BK Medical will immediately void any warranty supplied by BK Medical. Such changes will also void any service contract and result in charges to the customer for restoration of the original 2300 Ultrasound System.

  • Page 3: Table Of Contents

    Contents Chapter 1 General Information ............5 Essential Performance .
  • Page 4 3D ............32 Picture in Picture .

  • Page 5: Chapter 1 General Information

    Chapter 1 General Information This user guide is for all versions of the bk3000 and bk5000 ultrasound systems. Some of the functionality and options described in this guide may not be NOTE: available with your version of the system. Before using the equipment, please make yourself familiar with the information in the accompanying user information documents.

  • Page 6: Intended Use

    Emergency Medicine • Surgery • Anesthesia • Environment The bk3000 and bk5000 Ultrasound systems are suitable for use in the professional healthcare facility environment (e.g. hospitals, physician offices). Modes of Operation B-Mode (including Tissue Harmonic imaging) • M-Mode • PWD Mode •...

  • Page 7: Indications For Use

    Contraindications The bk3000 and bk5000 ultrasound systems are not intended for ophthalmic use • or any use causing the acoustic beam to pass through the eye.
  • Page 8 8 Chapter 1 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

  • Page 9: Chapter 2 Safety Information

    Table 2-1 contains brief explanations of the symbols and information used to label the equipment. (Some labels in the table may appear on the transducer.) BK Medical disclaims all responsibility for the operating safety, reliability and performance of the equipment if these symbols and warnings are disregarded in any way.
  • Page 10 When you dispose of the batteries you must follow national rules. Within the EU, you must send them to appropriate facilities for recovery and recycling. LI-ION Table 2-1. Symbols and information on the equipment. (continued) 10 Chapter 2 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

  • Page 11: General Safety Precautions

    United States Federal law restricts this device to sale to, or on the order of, a physician. Physicians only WARNING GS-w1 To ensure safe and proper use of the equipment, before you attempt to use BK Medical Proper equipment, you should be trained in ultrasonography or be under the supervision of Training someone who is trained in ultrasonography.

  • Page 12: Mechanical Safety

    All parts operating room) each part must be securely mounted to a stable support so that it does must be not tip, fall or come loose and injure someone. stable 12 Chapter 2 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

  • Page 13: Explosion Hazards

    Do not allow anyone but qualified shock service personnel to service the equipment. Caution F-c1 With Fusion sensor mounted, the transducer only complies with type B requirements of IEC 60601-1 bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information...

  • Page 14: Esd Training

    Repeating an examination can be regarded as a potential risk that should be avoided, especially if the examination involves transducers used intracorporeally or transducers used for puncture. 14 Chapter 2 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

  • Page 15: Rf (Radio Frequency) Interference

    30 cm (12 inches) to any interference sources part of the ultrasound system, including cables specified by BK Medical. Otherwise, degradation of the performance of this equipment could result. Caution Inter-c2...

  • Page 16: Connecting Other Equipment

    For detailed information about: network requirements • network configuration • workflow between devices • technical specifications • safety specifications • see the DICOM conformance statement at www.bkultrasound.com/support/bk/resources/DICOM 16 Chapter 2 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

  • Page 17: Network Security

    Otherwise you could risk overloading the network and your equipment failing. Network Printing For printing on network printers, BK supports protocols PCL 5, PCL 6 and PS (Post Script). bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information...

  • Page 18: Connectors

    Connectors As seen in Fig 2-2, the bk3000/bk5000 ultrasound system has four transducer sockets on the side of the system. PC connectors for connecting the system to equipment such as approved printers and video equipment are located on the rear of the system. Do not use connectors that are not labeled.
  • Page 19 Do Not Use on non-battery Connector models. USB 2.0 Micro Sub-D Connectors Do Not Use (3 - 6) S-video Out Microphone Audio Out Audio In Wi-Fi Dongle Figure 2-3. Connectors on the back of the system. bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information...
  • Page 20 VGA – this analog output from the DVI connector gives slightly poorer image quality than the digital DVI output. S-video – analog output Composite – signal with the most loss of information 20 Chapter 2 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

  • Page 21: Emc Requirements

    BNC (female) to Phono (male) Phono RCA (Composite) Not needed Table 2-3. Video connectors and adapters. EMC Requirements To fulfill EMC requirements, cables attached to the system must be shielded and no longer than 5 m. bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information...

  • Page 22: Isolation Of Dicom Network

    You must establish a secure wireless network at your hospital, clinic or institution, including a password for the network, before you can use the system’s Wi-Fi for printing and archiving. 22 Chapter 2 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)
  • Page 23 An advanced Wi-Fi setting option is available on the system using Windows connection configurations. Always follow the security procedures that have been established for your hospital, clinic or institution, as well as national guidelines. Contact your BK service representative for more information. bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information...

  • Page 24: Medical Equipment

    If any other electrical equipment/accessory is connected to the system, the system including this equipment and/or accessory will become a medical system. Medical systems must comply with EN/EIC 60601-1, ANSI/AAMI ES60601-1 or CAN/CSA C22.2 No. 60601-1. 24 Chapter 2 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

  • Page 25: Non-Medical Equipment

    The remote control can be disrupted by other equipment operating at the same frequency of 2.5 GHz. This device may not cause harmful interference This device must accept any interference received, including interference that may cause undesired operation bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information...

  • Page 26: Battery Support System

    Computer Security When BK systems are connected to a hospital network, BK Medical does not take any responsibility for computer viruses from the network that may infect the system.

  • Page 27: During An Examination

    Do not leave transducers in contact with the patient when using HF electrosurgical Electrical equipment. burns BK Medical transducers fulfill EMC requirements when they are outside as well as inside the patient’s body. WARNING T-w4 Do not turn the transducer on and allow it to scan into mid-air without ultrasound gel Surface applied to the surface of the array.

  • Page 28: Verifying The Transducer Type

    When you turn on Bubble Burst, the acoustic output limits are increased to 1.9 (MI). This change overrides any limits you have set. During Bubble Burst, the acoustic output will exceed normal contrast imaging values and may approach the higher (Bubble Burst) limits. 28 Chapter 2 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

  • Page 29: Vfi - Vector Flow Imaging

    WARNING VFI-w6 Check to make sure that the Doppler spectrum does not alias. Otherwise, the real-time Doppler volume flow measurement may not be precise. spectrum aliasing bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information...

  • Page 30: Puncture And Brachytherapy

    If you create a user-defined matrix, it is your responsibility to verify that the matrix that Verify user- appears on the monitor corresponds to the physical matrix you are using. defined matrix 30 Chapter 2 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

  • Page 31: Bkfusion

    The articulated arm can be adjusted with little force. Turn the central clamp in a clockwise direction to tighten the arm and anti-clockwise to loosen the arm. bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information...
  • Page 32 If you start to make a measurement on a 3D data set acquired using the untracked freehand method, the following warning appears on the monitor: Warning on Symbol Description monitor Measurement will not be accurate. 32 Chapter 2 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

  • Page 33: Picture In Picture

    Acoustic output data for transducers used with the system are given in the Technical Data (BZ2100) that accompanies this user guide. The uncertainty level for each parameter is also listed. For definitions of the parameters, refer to the Food and Drug bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information...

  • Page 34: Monitor Display

    SPTA , the maximum Mechanical Index (MI) must be  1.9, and the 720mW/cm maximum Thermal Index (TI) must be  6. All BK Medical transducers for use with bk3000 and bk5000 are Track 3. Monitor Display The Mechanical Index (MI) and Thermal Index (TI) can be viewed in all imaging modes.

  • Page 35: Acoustic Output Measurement

    MI nor TI SPTA value exceeds the maximum allowable value. When necessary, the system will reduce the output voltage and/or PRF (pulse repetition frequency) to the transducer to comply with requirements. bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information...

  • Page 36: Default Acoustic Output

    Clinical Measurements: Ranges and Accuracies This section states the accuracies for measurements made using the BK Medical range of ultrasound systems. A table containing accuracies for specific transducers can be found in the Technical Data (BZ2100) that accompanies this user guide.
  • Page 37 The user must always try to assess how large an inaccuracy is introduced by the selected step size, that is, the distance between organ cross sections. bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information...

  • Page 38: Geometric Measurements

    Geometric Measurements 2D Measurements The geometric measurements performed by BK Medical ultrasound systems are distance, perimeter, area and ellipsoid volume. The accuracy of these measurements is influenced by the following factors: Transducer geometry • Rounding of results • Resolution of digital image memory •...

  • Page 39: Doppler Measurements

     –       ------------------------------------------------    If the blood velocity exceeds the selected velocity range, aliasing occurs, corresponding to an overload condition of the measurement system. bk3000 & bk5000 User Guide (16-01249-EN-08) Safety Information...
  • Page 40 40 Chapter 2 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

  • Page 41: Battery Support

    Battery Location The battery is located in the battery compartment on the wheel base of the system. Battery compartment Figure 3-1. Battery in the wheel base. bk3000 & bk5000 User Guide (16-01249-EN-08) Battery Support...

  • Page 42: Power Supply

    When battery capacity is very low, A message appears on the monitor • The on-screen battery indicator turns red • The display on the battery compartment blinks regularly • 42 Chapter 3 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

  • Page 43: Power Save Mode

    Power save mode consumption when the system is not in active use. A message appears on the monitor to notify you when the system is about to go into power save mode. bk3000 & bk5000 User Guide (16-01249-EN-08) Battery Support...

  • Page 44: Battery Life

    To customize the operation of the battery, see the Battery Support Setup section in the Advanced User Guide relevant for your system. Cleaning and Disinfection The cleaning and disinfection instructions for the system in Care and Cleaning apply to the battery compartment. 44 Chapter 3 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

  • Page 45: Remote Control

    Chapter 4 Remote Control A wireless remote control is available for use with the bk5000 system. It uses Bluetooth to communicate with the system and control many of its functions. The Remote Control and Its Functions Battery cap Blue diode. Blinks to show Battery level.

  • Page 46: Calibrating The Remote Control

    To select an object on the monitor, move the remote control so that the cursor is on the object, then press Select 46 Chapter 4 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

  • Page 47: Replacing Batteries

    The remote control requires surface disinfection or sterilization as a minimum. The inside Remote battery compartment cannot be classified as disinfected or sterile. Follow procedures Control established for your hospital, clinic or institution to avoid cross-contamination when inserting or removing batteries. bk3000 & bk5000 User Guide (16-01249-EN-08) Remote Control...
  • Page 48 48 Chapter 4 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

  • Page 49: Getting Started

    Chapter 5 Getting Started Getting Started with bk3000 & bk5000 forms part of this user guide. bk3000 & bk5000 User Guide (16-01249-EN-08) Getting Started...
  • Page 50 50 Chapter 5 March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

  • Page 51: Index

    Index Numerics Creutzfeldt-Jakob warning 27 measurements warning 32 DICOM warning about untracked freehand and measure- conformance statement 16 ments 32 connection if network is not isolated 22 network isolator 22 standard 16 accuracy disposing of the system 10 2D geometric measurements 38 distorted image 14 3D distance 38 Doppler measurements...
  • Page 52 warning about changing offset of programmable puncture guides or brachy matrixes 30 leakage current 13 warning to verify puncture guide number 30 liquids, do not spill on system 12 pushing prohibited, symbol 9 magnetic shielding 14 radio frequency interference. See RF interference. manufacturer (symbol) 10 remote control measurements, Doppler warnings 28...
  • Page 53 USB, saving to. See Getting Started. displayed on the system 55 waste disposal symbol 10 WEEE waste (symbol) 10 VFI (Vector Flow Imaging), warnings about 29 Wi-Fi viewing an examination. See Getting Started. connecting to 22 virus correct setup and safe protocol required (cautions) checking external storage media 26 from network 26 network characteristics 23...

  • Page 55: Appendix A Warnings And Cautions Displayed On The System

    This list covers all warnings and cautions on systems bk3000, bk3500 and bk5000, so it may include warnings that are not relevant to your specific system.
  • Page 56 Curve name, x-axis and y-axis are required. Do Fill out required fields. not leave the fields empty. Default LCD backlight has not been adjusted. Adjust default LCD backlight. 56 Appendix A March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)
  • Page 57 Failed to open file "%s". \n%s Try again. Failed to process 3D volume. Failed to read catalog from database. Try again. Failed to read deleted Presets. Try again. Failed to read key action definitions from Try again. database. bk3000 & bk5000 User Guide (16-01249-EN-08)
  • Page 58 Hard disk space on %s is getting low. Free up hard disk space. Import of license keys from "%s" completed. Try again. The following license keys could not be imported: %s 58 Appendix A March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)
  • Page 59 IP address. Please insert the archive disc labeled "%s" and try again. Pro Package %s could not be deleted because it would leave some transducers without a Pro Package. bk3000 & bk5000 User Guide (16-01249-EN-08)
  • Page 60 The file does not contain a valid curve. Use valid curve. The file does not contain a valid Use valid measurement. measurement. The file size is too large to display on scanner 60 Appendix A March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)
  • Page 61 The procedure "%s" takes %d parameters. The report cannot be saved before a patient ID is entered. The report file cannot be generated: "%s" Try again. The same CD cannot contain both archived and non-archived documents. bk3000 & bk5000 User Guide (16-01249-EN-08)
  • Page 62 The volume name is not valid. It contains only illegal character(s). Please enter the new volume name. The volume name is too long. The name must be no longer than %d characters. 62 Appendix A March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)
  • Page 63 You must end the on-going exam before you can clear the patient archive. You must restart the scanner after you enable or disable the OEM interface. Your old password is not valid. Create new password. bk3000 & bk5000 User Guide (16-01249-EN-08)
  • Page 64 64 Appendix A March 2019 bk3000 & bk5000 User Guide (16-01249-EN-08)

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