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bk ultrasound bk3500 User Manual

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User Guide
bk3500 Ultrasound System
16-01410-EN-04
April 2017
For Professional Users Only

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  • Page 1 User Guide bk3500 Ultrasound System 16-01410-EN-04 April 2017 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 bk3500 Ultrasound System.

  • Page 3: Table Of Contents

    The bk3500 System ........
  • Page 4 Wireless Networks ..........38 Medical Equipment.

  • Page 5: Chapter 1 Introduction

    Chapter 1 Introduction This user guide is for the bk3500 ultrasound system. Before using the equipment, please make yourself familiar with the information in the accompanying user information documents. Some documents are printed. Make sure that you also read the transducer user guide and specifications for each transducer that you use.

  • Page 6: Intended Use

    • • Vascular • Cardiology • OB/GYN • Modes of Operation B-Mode (including Tissue Harmonic imaging) • M-Mode • PWD Mode • CFM Mode • Power Doppler • CW Doppler • 6 Chapter 1 April 2017 bk3500 User Guide (16-01410-EN-04)

  • Page 7: Indications For Use

    Contraindications The bk3500 ultrasound system is not intended for ophthalmic use or any use • causing the acoustic beam to pass through the eye.
  • Page 8 Upper gastrointestinal bleeding significant dysphagia and odynphagia are also • relative contraindications. NOTE: These contraindications are typical examples of what the examining physician must consider before the examination. The list is not all-inclusive. 8 Chapter 1 April 2017 bk3500 User Guide (16-01410-EN-04)

  • Page 9: Chapter 2 Getting Started

    Getting Started The bk3500 System Monitor Endotransducer holder Touch screen Control panel Transducer holders Front handle with release handles Transducer sockets Scan engine Baskets for accessories Lockable wheels Battery display Battery cover Battery compartment bk3500 User Guide (16-01410-EN-04) Getting Started...

  • Page 10: Before You Start

    Make sure system is running. Press the power button once. Caution BS-c2 Never shut down a system with a battery module simply by unplugging it from the wall. To preserve battery power, shut down the system properly. 10 Chapter 2 April 2017 bk3500 User Guide (16-01410-EN-04)

  • Page 11: Connecting Transducers

    Figure 2-3. Message if the active transducer is disconnected. Barcode Reader To enter Patient Information with the barcode reader: Tap the touch screen Patient button. With the cursor in the Patient ID field, scan the relevant patient barcode with the barcode reader. bk3500 User Guide (16-01410-EN-04) Getting Started...

  • Page 12: Control Panel

    Opens the quick exam start-up workflow. When the exam has started, the Q button works as an Auto QUICK ACCESS button which will automatically optimize the image button settings. 12 Chapter 2 April 2017 bk3500 User Guide (16-01410-EN-04)

  • Page 13: Quick Access

    Quick Exam Start-Up Once the button is selected, users can navigate through the Quick Exam Start- up using the touch screen: Enter Patient Information. Select Transducer. Select Application (Exam type). Select Imaging Preset. Begin the exam. bk3500 User Guide (16-01410-EN-04) Getting Started...
  • Page 14 ID or use a barcode reader. See “Barcode Reader” on page 11. Figure 2-5. Patient window. Swipe the screen from right to left to enter additional patient information. Figure 2-6. Second screen in Patient window. 14 Chapter 2 April 2017 bk3500 User Guide (16-01410-EN-04)
  • Page 15 Tap the Exam Info button to add specific information relevant for the exam, and tap Next. Figure 2-7. Exam Info window. Select Transducer (in this case 6C2 is selected). Figure 2-8. List of available transducers (those that are plugged in). bk3500 User Guide (16-01410-EN-04) Getting Started...
  • Page 16 (in this case 6C2). Figure 2-9. List of available applications. Select imaging Preset: The imaging presets available are dependent on the transducer and the application (exam type) selected. Figure 2-10. Available presets. 16 Chapter 2 April 2017 bk3500 User Guide (16-01410-EN-04)
  • Page 17 If, after beginning an exam without entering any Patient information, you want to save an image, you must verify that the system auto-created a properly configured Patient ID before exiting the exam. Whenever possible, BK recommends that you also enter a complete Patient Name. bk3500 User Guide (16-01410-EN-04) Getting Started...

  • Page 18: Starting An Exam Using The Touch Screen Buttons

    Exam Info button. See steps 3 and 4 above. • To use the transducer, application and preset already selected on the system, tap Start Exam. Otherwise, continue your selection by tapping the relevant main button (see Fig 2-18). 18 Chapter 2 April 2017 bk3500 User Guide (16-01410-EN-04)
  • Page 19 • To use the application and preset already selected on the system, continue the exam. Otherwise, continue your selection. • To select Application, tap the application you want. Figure 2-14. Application window when using the touch screen buttons. bk3500 User Guide (16-01410-EN-04) Getting Started...
  • Page 20 Figure 2-15. The preset window when using the touch screen buttons. Figure 2-16. The touch screen in Basic layout during an exam. The exam ends when you tap End Exam. • 20 Chapter 2 April 2017 bk3500 User Guide (16-01410-EN-04)

  • Page 21: Monitor And Touch Screen Display

    Monitor and Touch Screen Display Hospital Patient Exam type Trans- ducer Operator Biopsy line Image data including battery status Measure- ment data Review tab with browser Figure 2-17. Monitor (clinical display). bk3500 User Guide (16-01410-EN-04) Getting Started...
  • Page 22 Figure 2-18. Touch screen Advanced layout. Exam Management Mode function Image parameter Touch screen buttons buttons buttons dials Function buttons, including the Mode buttons Home button. Figure 2-19. Touch screen Basic layout. 22 Chapter 2 April 2017 bk3500 User Guide (16-01410-EN-04)

  • Page 23: Battery

    Function buttons to return to default settings for the current exam type. The functions are described further in the bk3500 Advanced User Guide. You select or deselect a button by tapping it. • The buttons and window elements in the exam management and function button •...

  • Page 24: Battery Status

    Caution BS-c1 If the battery reaches the auto-shutdown level, plug in the system and keep it plugged in until the battery recharges to at least 10 %. 24 Chapter 2 April 2017 bk3500 User Guide (16-01410-EN-04)

  • Page 25: Battery Life

    On average, a battery will need to be replaced after approximately 300 recharge and discharge cycles – the battery lifespan. Contact your BK service representative for replacement of batteries. For information about the disposal of depleted batteries, see page 40. bk3500 User Guide (16-01410-EN-04) Getting Started...
  • Page 26 26 Chapter 2 April 2017 bk3500 User Guide (16-01410-EN-04)

  • Page 27: Chapter 3 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 3-1. Symbols and information on the equipment. bk3500 User Guide (16-01410-EN-04) Safety Information...
  • Page 28 Battery recycle Recycle used batteries properly. China ROHS 25 Years Environmentally Friendly Use Period for ROHS is 25 Lifetime years. Table 3-1. Symbols and information on the equipment. (continued) 28 Chapter 3 April 2017 bk3500 User Guide (16-01410-EN-04)

  • Page 29: General Safety Precautions

    Caution S-c2b The ultrasound system control panel is not watertight. Be careful not to spill any liquids, Spilled gel or moist substances on either the buttons or the touch screen. liquids bk3500 User Guide (16-01410-EN-04) Safety Information...

  • Page 30: Mechanical Safety

    To avoid injury and equipment damage, do not push the system too hard, especially when Don’t push you roll the system over an uneven surface. Applying excessive force near the top could too hard cause the system to overbalance and tilt. 30 Chapter 3 April 2017 bk3500 User Guide (16-01410-EN-04)

  • Page 31: Explosion Hazards

    You can use a wrist strap connected to the additional protective ground or potential • equalization terminal on the system if that is more convenient. bk3500 User Guide (16-01410-EN-04) Safety Information...

  • Page 32: Interference

    Interference The bk3500 Ultrasound System is suitable for use in most healthcare establishments, other than domestic establishments and those directly connected to the public low- voltage power supply network that supplies buildings used for domestic purposes. Electrical Noise WARNING EN-w1 Electrical noise from nearby devices such as electrosurgical devices –...

  • Page 33: Installation

    Do NOT use it for additional protective grounding. Figure 3-1. The terminals for additional protective ground and potential equalization are on each side of the stand underneath the control panel. bk3500 User Guide (16-01410-EN-04) Safety Information...

  • Page 34: Connecting Other Equipment

    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). 34 Chapter 3 April 2017 bk3500 User Guide (16-01410-EN-04)

  • Page 35: Connectors

    Connectors As seen in Fig 3-2, the bk3500 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 36 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 3-3 shows you which adapters can be used. 36 Chapter 3 April 2017 bk3500 User Guide (16-01410-EN-04)

  • Page 37: Emc Requirements

    BNC (female) to Phono (male) Phono RCA (Composite) Not needed Table 3-3. Video connectors and adapters. EMC Requirements To fulfill EMC requirements, cables attached to the system must be shielded and no longer than 5 m. bk3500 User Guide (16-01410-EN-04) Safety Information...

  • Page 38: Isolation Of Dicom Network

    Wi-Fi for printing and archiving. For setting up a wireless network, see the bk3500 Advanced User Guide. Caution Wifi-c1 The network must be set up correctly so that data is sent to the correct location. Otherwise data can be lost or accessed by unauthorized people.

  • Page 39: Medical Equipment

    The system is grounded with an additional safety ground connection (see “Additional • Protective Ground and Potential Equalization” on page 33). If in doubt, contact your BK service representative. bk3500 User Guide (16-01410-EN-04) Safety Information...

  • Page 40: Battery Support System

    Caution CS-c2 We recommend that you perform regular backups to protect patient data. See Exporting Data in the bk3500 Advanced User Guide. Printer Caution Print-c1 The quality of a printed ultrasound image may vary, depending on the printer.

  • Page 41: Service And Repair

    To avoid this, freeze the image when the transducer is not used for imaging. During an Examination Checking the Date Before you start imaging, verify that the date and time displayed on the monitor are correct. bk3500 User Guide (16-01410-EN-04) Safety Information...

  • Page 42: Verifying The Transducer Type

    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 42 Chapter 3 April 2017 bk3500 User Guide (16-01410-EN-04)

  • Page 43: Vfi - Vector Flow Imaging

    In case of any inconsistency, stop imaging, turn off the system, and contact your BK service representative. bk3500 User Guide (16-01410-EN-04) Safety Information...

  • Page 44: Acoustic Output

    Take into account all the types of tissue that may be affected. For example, when • imaging a breast, it may be appropriate to monitor the TI (Thermal Index)in bone rather than in soft tissue because the ribs will be subjected to ultrasound. 44 Chapter 3 April 2017 bk3500 User Guide (16-01410-EN-04)

  • Page 45: Monitor Display

    , the maximum Mechanical Index (MI) must be  1.9, and the maximum Thermal Index (TI) must be  6. All BK transducers for use with the bk3500 Ultrasound System are Track 3. Monitor Display The Mechanical Index (MI) and Thermal Index (TI) can be viewed in all imaging modes.
  • Page 46 (in MHz) TI Formula ------------ - where the variables are defined in the table below. Variable Definition time-averaged acoustic power of the source or other power parameter (W) 46 Chapter 3 April 2017 bk3500 User Guide (16-01410-EN-04)

  • Page 47: Acoustic Output Measurement

    If you use high acoustic output levels for some reason (see “Functions Affecting Acoustic Output”, below), be sure to return to B-mode alone and turn down the power level before you do any fetal imaging. bk3500 User Guide (16-01410-EN-04) Safety Information...

  • Page 48: Functions Affecting Acoustic Output

    This section states the accuracies for measurements made using the BK range of ultrasound systems. A table containing accuracies for specific transducers can be found in the Technical Data (BZ2100) that accompanies this user guide. 48 Chapter 3 April 2017 bk3500 User Guide (16-01410-EN-04)
  • Page 49 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. bk3500 User Guide (16-01410-EN-04) Safety Information...

  • Page 50: Geometric Measurements

    Geometric Measurements 2D Measurements The geometric measurements performed by BK 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 51: Index

    Index electrical shock 31 electromagnetic compatibility. See EMC. accuracy electromagnetic interference 32 2D geometric measurements 50 clinical measurements explained 48 attaching cables 37 Doppler measurements 50 data in BZ2100 5 time difference measurements 50 noise, checking for 32 acoustic output precautions 32 default 48 equipment failure 29...
  • Page 52 guidelines 34 security, network. See network security. responsibility for 34 service and repair 41 noise standby (symbol) 28 electrical 32 system EMC 32 isolation from line voltage 29 non-medical equipment, connecting to system 39 malfunction 29 overbalance and tipping Technical Data (BZ2100) 5 warning 30 Thermal Index limit warning symbol 27...

  • Page 53: Warnings And Cautions Displayed On The System

    BK service technician if you encounter a persistent problem that can not be solved by the suggested action(s) below. 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 54 Could not create temporary subdirectory for Try again. outgoing mail data. 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. April 2017 bk3500 User Guide (16-01410-EN-04)
  • Page 55 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. bk3500 User Guide (16-01410-EN-04) Warnings and Cautions Displayed on the System...
  • Page 56 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 April 2017 bk3500 User Guide (16-01410-EN-04)
  • Page 57 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. bk3500 User Guide (16-01410-EN-04) Warnings and Cautions Displayed on the System...
  • Page 58 The document cannot be displayed. Currently Install a viewer. there is no viewer available. The entered license key has expired: %s. The entered license key is invalid. Type in valid license key. The field must not be empty. April 2017 bk3500 User Guide (16-01410-EN-04)
  • Page 59 Use valid measurement type. The media was not burned: %s The name ""%s"" is already used. The name is invalid. The port number is invalid The procedure "%s" takes %d parameters. bk3500 User Guide (16-01410-EN-04) Warnings and Cautions Displayed on the System...
  • Page 60 "%s". The value "%s" (%s) is outside the legal range Keep value (s) within legal range. (%.2f - %.2f). The volume name is already used in the patient archiving system. Please enter another name. April 2017 bk3500 User Guide (16-01410-EN-04)
  • Page 61 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. bk3500 User Guide (16-01410-EN-04) Warnings and Cautions Displayed on the System...
  • Page 62 April 2017 bk3500 User Guide (16-01410-EN-04)

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