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bk ultrasound bk3000 User Manual

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bk3000 Ultrasound System
bk3000 Ultrasound System
16-01249-EN-01
16-01249-EN-01
January 2015
January 2015
 
 
For Professional Users Only
For Professional Users Only

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  • Page 1     bk3000 Ultrasound System bk3000 Ultrasound System 16-01249-EN-01 16-01249-EN-01 January 2015 January 2015 For Professional Users Only For Professional Users Only...
  • Page 2 Ultrasound void any service contract and result in charges to the customer for restoration of the original bk3000 Ultrasound System.
  • Page 3 Ultrasound void any service contract and result in charges to the customer for restoration of the original bk3000 Ultrasound System.

  • Page 4: Table Of Contents

    Contents Contents Chapter Chapter General General Information . . Information ..5 . . 5 Essential Pe Essential Performance rformance ........
  • Page 5 Acoustic Ou Acoustic Output Meas tput Measurement urement ..............

  • Page 6: Chapter 1 General Information

    User Guide bk3000 User Guide ( ( 1 1 6 6 - - 0 0 1 1 2 2 4 4 9 9 - - E E N N - - 0 0 1 1 ) ) G G e e n n e e r r a a l l I I n n f f o o r r m m a a t t i i o o n n...

  • Page 7: Intended Use

    1. In the USA, contrast-enhanced ultrasound has not been market cleared by the FDA, with the exception of select cardiac imaging applications. 2. CW Doppler on the bk3000 has not been market cleared by the FDA or licensed by Health Canada.

  • Page 8: Indications For Use Indicatio Ns For Use

    Contraindications • The bk3000 ultrasound system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye. • The Cardiac Adult application is not intended for direct use on the heart.
  • Page 9 8 Chapter 1 January 2015 bk3000 User Guide (16-01249-EN-01)

  • Page 10: Chapter 2 Safety Information

    Pushing prohibited Do not use excessive force to push the system. Excessive force when pushing over uneven surfaces can cause the system to overbalance and tip. Table 2-1. Symbols and information on the equipment. bk3000 User Guide (16-01249-EN-01) Safety Information...

  • Page 11: General Safety Precautions

    (2006) (Part 1: General requirements for basic safety and essential performance) and EN 60601–2–37 (2007) (Particular requirements for the basic safety and essential  performance of ultrasonic medical diagnostic and monitoring equipment). 10 Chapter 2 January 2015 bk3000 User Guide (16-01249-EN-01)
  • Page 12 Wait at least 2 hours after the system has been subjected to major changes in • temperature or humidity. If there is visible evidence of condensation, wait at least 8 hours. • bk3000 User Guide (16-01249-EN-01) Safety Information...

  • Page 13: Explosion Hazards

    The system should be placed at least 25 cm (10 inches) from the patient. The ultrasound system contains a lithium battery. Never remove or replace this battery. The lithium battery must not be removed except by a BK Medical service representative. 12 Chapter 2 January 2015 bk3000 User Guide (16-01249-EN-01)

  • Page 14: Electrical Safety

    Electrical noise from nearby devices such as electrosurgical devices – or from devices that Electrical can transmit electrical noise to the AC line – may cause disturbances in ultrasound images. noise This could increase the risk during diagnostic or interventional procedures. bk3000 User Guide (16-01249-EN-01) Safety Information...

  • Page 15: Electromagnetic Interference

    Caution Inter-c2 Use specified Caution: If you use accessories, transducers or cables with the system, other than those equipment specified, increased emission or decreased immunity of the system may result. only 14 Chapter 2 January 2015 bk3000 User Guide (16-01249-EN-01)

  • Page 16: Installation

     Figure 2-1. The terminals for potential equalization and additional protective ground are underneath the control panel. Connecting Other Equipment For connection to other equipment, BK Medical systems have a communication  protocol on top of TCP/IP bk3000 User Guide (16-01249-EN-01) Safety Information...

  • Page 17: Network Network Connectio Connection

    PS (Post Script). Connectors PC connectors for connecting the system to other equipment such as approved  printers and video equipment are located on the rear of the system. See Fig 2-3. 16 Chapter 2 January 2015 bk3000 User Guide (16-01249-EN-01)
  • Page 18 More information about the connectors is in Table 2-2. Information about the cables to use is in Table 2-4. The bk3000 ultrasound system has four transducer sockets on the side of the system. See Fig 2-2.  Figure 2-2. Transducer sockets.
  • Page 19 Power supply cord goes here  Figure 2-3. System connectors. 18 Chapter 2 January 2015 bk3000 User Guide (16-01249-EN-01)
  • Page 20 Composite – signal with the most loss of information If you must use a cable that does not have a DVI connector, you may need to use an adapter. Table 2-3 shows you which adapters can be used. bk3000 User Guide (16-01249-EN-01) Safety Information...

  • Page 21: Emc Requirements Emc Requir Ements

    (same view on both connectors) 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. 20 Chapter 2 January 2015 bk3000 User Guide (16-01249-EN-01)

  • Page 22: Wireless Networks

    Wi-Fi for  printing and archiving. 1. Wi-Fi on the bk3000 has not been market cleared by the FDA or licensed by Health Canada. bk3000 User Guide (16-01249-EN-01) Safety Information...
  • Page 23 An advanced Wi-Fi setting option is available on the system using Windows configurations. Always follow the security procedures that have been established for your hospital, clinic or institution, as well as national guidelines. Contact your BK Medical service representative for more information. 22 Chapter 2 January 2015 bk3000 User Guide (16-01249-EN-01)

  • Page 24: Medical Equipment

    • The system and other equipment are plugged into an external common isolation • transformer to control the leakage current during a ground connection fault. If in doubt, contact your local BK Medical representative. bk3000 User Guide (16-01249-EN-01) Safety Information...

  • Page 25: Non-Med Non-Medical Equip Ical Equipment Ment

    An approved printer, specified in the Product Data sheet, can be connected to the internal Printers and auxiliary power outlet on the system. Do not use the auxiliary power outlet on the bk3000 auxiliary ultrasound system for any other equipment.

  • Page 26: Service And Repair

    Before you start imaging, verify that the date and time displayed on the monitor are correct. WARNING Exam-w1 An incorrect date or time will make documentation of the image incorrect and may also Date cause some calculated values to be incorrect. bk3000 User Guide (16-01249-EN-01) Safety Information...

  • Page 27: Measurements

    If they are not, you must adjust the position of the cursors manually. Nuchal Translucency Caution NT-c1 You must be adequately trained before you attempt to make nuchal translucency Nuchal measurements. translucency 26 Chapter 2 January 2015 bk3000 User Guide (16-01249-EN-01)

  • Page 28: Vfi - Vector Flow Imaging

    In case of any inconsistency, stop imaging, turn off the system, and contact your local BK Medical representative. 1. Vector Flow Imaging on the bk3000 has not been market cleared by the FDA or licensed by Health Canada. bk3000 User Guide (16-01249-EN-01)
  • Page 29 Then check the matrix alignment. See alignment Care, Cleaning & Safety    for instructions. Pay particular care to the following safety issues when operating the 3D system. 28 Chapter 2 January 2015 bk3000 User Guide (16-01249-EN-01)

  • Page 30: Picture In Pi Picture In Picture Cture

    EN60601-2-37 (Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment). Prudent Use WARNING AO-w1  Always keep the exposure level (the acoustic output level and the exposure time) as low as Exposure  possible. level bk3000 User Guide (16-01249-EN-01) Safety Information...

  • Page 31: Monitor Display

    Low As Reasonably Achievable) principle using an indicator related to a potential  bioeffect. The full details of the indices are given in references EN60601-2-37 and AIUM/NEMA standard, but the formulas are given below. 30 Chapter 2 January 2015 bk3000 User Guide (16-01249-EN-01)
  • Page 32 Variable Definition Intensity in water at the position where I is maximum transducer frequency (in MHz) distance (in cm) from the transducer face to the position where I is maximum bk3000 User Guide (16-01249-EN-01) Safety Information...
  • Page 33 The default setup may be factory-defined or defined by the user. The factory-defined default setup values of acoustic output for each transducer are listed in the Technical Data (BZ2100). 32 Chapter 2 January 2015 bk3000 User Guide (16-01249-EN-01)
  • Page 34 (see Fig 2-6). The system bases the calculation of the ellipsoid volume on the convex hull. bk3000 User Guide (16-01249-EN-01) Safety Information...
  • Page 35 The accuracy of a distance measurement on a 3D image will never be bette r than 6%; area accuracy the accuracy of an area measurement on a 3D image will never be better than 6%. 34 Chapter 2 January 2015 bk3000 User Guide (16-01249-EN-01)
  • Page 36         –   ------------- --------------- ---------------- ----      If the blood velocity exceeds the selected velocity range, aliasing occurs, corresponding to an overload condition of the measurement system. bk3000 User Guide (16-01249-EN-01) Safety Information...
  • Page 37 36 Chapter 2 January 2015 bk3000 User Guide (16-01249-EN-01)
  • Page 38 Chapter 3 Getting Started Getting Started with bk3000 forms part of this user guide. bk3000 User Guide (16-01249-EN-01) Getting Started...
  • Page 39 38 Chapter 3 January 2015 bk3000 User Guide (16-01249-EN-01)
  • Page 40 Index Numerics earth. See ground. warning about untracked freehand and measure- electrical noise 13 ments 29 electrical safety 15 electrical shock 13 electromagnetic compatibility. See EMC. accuracy electromagnetic interference 14 2D geometric measurements 34 3D distance 34 attaching cables 20 3D measurements 34 data in BZ2100 5 3D volume 34 noise, checking for 14...
  • Page 41 connecting to system 23 RF interference 14 MI (Mechanical Index) and ALARA 30 formula 31 safety modes of operation 6 electrical 13 monitor brightness, adjusting. See Getting Started. transducer 25 saving to USB. See Getting Started. screen controls, basic, overview. See Getting Started. network ...
  • Page 42 Wi-Fi  password 22 connecting to 21 signal strength 22 correct setup and safe protocol required (cautions) using 21 wireless network. See Wi-Fi. network characteristics 23...
  • Page 44 Use valid height setting. The guide's horizontal holes/cm is invalid. Use valid horizontal holes/cm setting The guide's horizontal offset is invalid. Use valid horizontal offset setting. The guide's name is invalid. Use valid guide name. bk3000 User Guide (16-01249-EN-01) January 2015...
  • Page 45 Warning: MTF Raw volume. Measurements may be inaccurate. \nDo you wish to continue? Continue or discontinue. Warning: Untracked volume. Measurements may be inaccurate! Warning: Untracked volume. Measurements may be inaccurate. \nDo you wish to continue? 44 Appendix A January 2015 bk3000 User Guide (16-01249-EN-01)
  • Page 46 Include user-defined puncture guide. puncture guide. Failed to acquire 3D volume.\n\n%s Try again. Failed to calculate expression "%s": %s. Try again. Failed to calculate measurement. \nSyntax Check formula. error in formula. Failed to configure the server. Try again. bk3000 User Guide (16-01249-EN-01)
  • Page 47 Failed to save measurement in database. Try again. Failed to send SMTP message (%s). Try again. Failed to store catalog in database. Try again. Failed to store clip in file. Try again. 46 Appendix A January 2015 bk3000 User Guide (16-01249-EN-01)
  • Page 48 Please enter a number Please enter an SMTP Server Address.\nIt must be entered as a name or an IP address. Please insert the archive disc labeled "%s" and try again. bk3000 User Guide (16-01249-EN-01)
  • Page 49 The file does not contain a valid Use valid measurement. measurement. The formula exceeds the maximum length of Reduce length. %d characters. The measurement cannot be edited. The Contact service technician. template contains errors. 48 Appendix A January 2015 bk3000 User Guide (16-01249-EN-01)
  • Page 50 The tool attribute %s is invalid. Use valid tool attribute. The two passwords you have typed are not identical. The USB Device cannot be safely removed. Try again. The user already exists. Enter a different username. bk3000 User Guide (16-01249-EN-01)
  • Page 51 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. 50 Appendix A January 2015 bk3000 User Guide (16-01249-EN-01)

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