BK Medical Flex Focus 1202 User Manual
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BK Medical Flex Focus 1202 User Manual

Ultrasound system. for professional users only
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See also: Advanced User's Manual
Flex Focus
Ultrasound Systems
English
BB1756-S
October 2018
User Guide
Type 1202
For Professional Users Only

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Summary of Contents for BK Medical Flex Focus 1202

  • Page 1 User Guide Type 1202 Flex Focus Ultrasound Systems English BB1756-S October 2018 For Professional Users Only...
  • Page 2 Any modification of or installation of software without written permission fromBK 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 Flex Focus 1202 Ultrasound System.

  • Page 3: Table Of Contents

    Contents Chapter 1 General Information ............5 Essential Performance .
  • Page 4 Puncture and Brachytherapy........33 3D .

  • Page 5: Chapter 1 General Information

    Chapter 1 General Information This user guide is for all versions of the Flex Focus 1202 Ultrasound System (scanner unit and dock) from BK Medical. The system is a 2D and 3D ultrasound echo and flow imaging system for diagnosis, Intended use data processing and transfer and guidance of puncture and biopsy.

  • Page 6: Intended Use

    Emergency Medicine • Surgery • Anesthesia • Environment Flex Focus 1202 Ultrasound System is 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 Flex Focus 1202 ultrasound system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye. Flex Focus 1202 User Guide (BB1756-S)
  • Page 8 8 Chapter 1 October 2018 Flex Focus 1202 User Guide (BB1756-S)

  • 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 China ROHS 25 Years Environmentally Friendly Use Period for ROHS is 25 Lifetime years. Table 2-1. Symbols and information on the equipment. (continued) 10 Chapter 2 October 2018 Flex Focus 1202 User Guide (BB1756-S)

  • Page 11: General Safety Precautions

    In addition, if your system interacts with other equipment directly or indirectly, you need to make sure the interactions are both safe and secure. No further training is required, but BK offers training in how to use the system. Consult your BK representative for information. Flex Focus 1202 User Guide (BB1756-S) Safety Information...

  • Page 12: Mechanical Safety

    Before you use the equipment, make sure that all the safety requirements described in this chapter have been satisfied. Mechanical Safety Mechanical failure or unintended use of ultrasound equipment can result in physical injury to patients or operators. 12 Chapter 2 October 2018 Flex Focus 1202 User Guide (BB1756-S)

  • Page 13: Explosion Hazards

    • specified in EN/IEC 60601-1 (Part 1: General requirements for safety). the impedance of the ground connection could exceed the limits specified in EN/IEC • 60601-1. Flex Focus 1202 User Guide (BB1756-S) Safety Information...

  • Page 14: Esd Training

    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. 14 Chapter 2 October 2018 Flex Focus 1202 User Guide (BB1756-S)

  • Page 15: Electromagnetic Interference

    Possible cables and external antennas) should be used no closer than 30 cm (12 inches) to any interference part of the ultrasound system, including cables specified by BK Medical. Otherwise, sources degradation of the performance of this equipment could result.

  • 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 16 Chapter 2 October 2018...

  • Page 17: Network Connection

    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). Flex Focus 1202 User Guide (BB1756-S) Safety Information...

  • Page 18: Connectors

    12 V outlet in the neck. More information about the connectors is in Table 2-2. Information about the cables to use is in Table 2-4. 18 Chapter 2 October 2018 Flex Focus 1202 User Guide (BB1756-S)
  • Page 19 Click new ones in place Figure 2-3. Connectors in the neck of the Flex Focus system. The socket comes with a fuse cassette, located just above it. The cassette contains two fuses. Flex Focus 1202 User Guide (BB1756-S) Safety Information...
  • Page 20 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. 20 Chapter 2 October 2018 Flex Focus 1202 User Guide (BB1756-S)
  • Page 21 DVI to VGA adapter (2 views) DVI-I BNC (Composite) 7-pin S-video to Composite + BNC (female) to Phone (male) Phono RCA (Composite) 7-pin S-video to Composite Table 2-3. Video connectors and adapters. Flex Focus 1202 User Guide (BB1756-S) Safety Information...

  • Page 22: Histoscanning

    Connect the lithotriptor to a USB connector on the system. If necessary, use a USB RS-232 adapter cable. 1. HistoScanning has not been market cleared by the FDA or licensed by Health Canada. 22 Chapter 2 October 2018 Flex Focus 1202 User Guide (BB1756-S)

  • Page 23: Emc Requirements

    This requires the optional wireless license for the system, and a Wi-Fi adapter that is supplied by BK Medical when you buy this option. The Wi-Fi adapter is inserted into one of the USB connectors located in the neck of the system (see Fig 2-3 on page 19).
  • Page 24 Figure 2-5. Position of the Wi-Fi symbol on the screen. To connect to a wireless network, click the Wi-Fi logo, choose the appropriate network, and type in the password. Figure 2-6. Wi-Fi connection window. 24 Chapter 2 October 2018 Flex Focus 1202 User Guide (BB1756-S)
  • Page 25 For information on saving and printing using the DICOM protocol, see the DICOM chapter in Flex Focus 1202 Advanced User Guide (BB1949). 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 26: Medical Equipment

    The auxiliary power outlet is still live even when the ON/Standby button on the system is turned off. To remove voltage from this outlet, you must unplug the power supply cord ON/Standby from the power source. button does not turn off outlet 26 Chapter 2 October 2018 Flex Focus 1202 User Guide (BB1756-S)

  • Page 27: Non-Medical Equipment

    When you dispose of the batteries, you must follow national rules. Within the EU, Battery disposal you must send them to appropriate facilities for recovery and recycling. Flex Focus 1202 User Guide (BB1756-S) Safety Information...

  • Page 28: If The System Will Not Start

    Keep away from children. <100Wh Lithium ion rechargeable battery. 0% Hg, 0% Cd, 0%Pb. For optimal performance use BK Medical equipment for charging. Must be recycled or disposed of properly. Recycle facilities may not be available in all areas. Charge before use.

  • Page 29: Remote Control

    This device must accept any interference received, including interference that may cause undesired operation. Computer Security When the Flex Focus is connected to a hospital network, BK Medical does not take any responsibility for computer viruses from the network that may infect the Flex Focus.

  • Page 30: Service And Repair

    Service and Repair WARNING SR-w1 Service and repair of BK Medical electromedical equipment must be carried out only by Authorized the manufacturer or its authorized representatives. BK Medical reserves the right to personnel disclaim all responsibility, including but not limited to responsibility for the operating safety, reliability and performance of equipment serviced or repaired by other parties.

  • Page 31: During An Examination

    (as in forming a curve like a figure eight, for example), the area calculation is incorrect. In this case, the calculated area of the polygon is the area of the bigger loop minus the area of the smaller loop. Flex Focus 1202 User Guide (BB1756-S) Safety Information...

  • Page 32: Vfi - Vector Flow Imaging

    WARNING VFI-w5 Check to make sure that the Doppler gate only covers one vessel. Otherwise, the real-time Doppler gate volume flow measurement may not be precise. over only one vessel 32 Chapter 2 October 2018 Flex Focus 1202 User Guide (BB1756-S)

  • Page 33: Puncture And Brachytherapy

    Brachytherapy and Prostate Transperineal Biopsy WARNING B-w1 Verify that the matrix type and coordinates displayed on the monitor agree with the actual Verify matrix matrix template you are using. type and coordinates Flex Focus 1202 User Guide (BB1756-S) Safety Information...

  • Page 34: Picture In Picture

    When you use Picture in Picture, do not cover critical information (such as TI or MI) on the PiP must not monitor. Make sure that all important information will appear if you print or save the cover ultrasound image. important information 34 Chapter 2 October 2018 Flex Focus 1202 User Guide (BB1756-S)

  • Page 35: Acoustic Output

    720mW/cm , the maximum Mechanical Index (MI) must be  1.9, and the maximum Thermal Index (TI) must be  6. All BK Medical transducers for use with the Flex Focus 1202 Ultrasound System are Track 3. Flex Focus 1202 User Guide (BB1756-S)

  • Page 36: Monitor Display

    TI indicates. A temperature increase of one degree Celsius increase in a patient with fever may Fever cause complications in certain circumstances; it may be safer to delay the investigation. 36 Chapter 2 October 2018 Flex Focus 1202 User Guide (BB1756-S)

  • Page 37: 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. Flex Focus 1202 User Guide (BB1756-S) Safety Information...

  • Page 38: 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 39 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. Flex Focus 1202 User Guide (BB1756-S) Safety Information...

  • Page 40: 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 41: Doppler Measurements

    Diagnostic Ultrasound Equipment. AIUM/NEMA. 2004. [11] Medical Ultrasound Safety. Second edition. AIUM. 2009. [12] ALARA Training Program. Ultrasound III Training. BK Medical. 1993. [13] Bioeffects considerations for the safety of diagnostic ultrasound. Journal of Ultrasound in Medicine, Vol. 7, No. 9 (supplement). September 1988.
  • Page 42 CSA: Canadian Standards Association EN: European Standards FDA: Food and Drug Administration (USA) IEC: International Electrotechnical Commission NEC: National Electrical Code NEMA: National Electrical Manufacturers Association UL: Underwriters Laboratories Inc., USA 42 Chapter 2 October 2018 Flex Focus 1202 User Guide (BB1756-S)

  • Page 43: Adjusting The System

    The range for tilting the monitor is approximately 15°. If you adjust the angle of the screen, you should check the calibration of the touch screen to ensure accuracy. Flex Focus 1202 User Guide (BB1756-S) Adjusting the System...
  • Page 44 44 Chapter 3 October 2018 Flex Focus 1202 User Guide (BB1756-S)

  • Page 45: Battery Support

    50), unplug from the wall and run on battery power again. Battery Pack Location The battery pack is located in the bottom drawer of the backpack on the mobile battery keyboard dock. Flex Focus 1202 User Guide (BB1756-S) Battery Support...

  • Page 46: Power Supply

    Display Power supply Push tab to release fuses. Click new ones in place. Figure 4-2. The back of the battery pack. 46 Chapter 4 October 2018 Flex Focus 1202 User Guide (BB1756-S)

  • Page 47: Charging The Batteries

    Always check before using for the first time. When using new batteries in the system, BK Medical recommends that you plug in the system for approximately 1.5 hours to charge the batteries fully.

  • Page 48: Information Available On Battery Pack

    When battery capacity is very low, The system beeps • A message appears on the monitor • The on-screen battery indicator turns red • The display on the battery box blinks regularly • 48 Chapter 4 October 2018 Flex Focus 1202 User Guide (BB1756-S)

  • Page 49: Power Save Mode

    To exit power save mode and restore the system to normal power, you can do one of the following: Press a key on the keyboard • Press the transducer button • Move the trackball • To enable and configure power save mode, see Flex Focus Advanced User Guide. Flex Focus 1202 User Guide (BB1756-S) Battery Support...

  • Page 50: Changing Or Replacing A Battery

    With typical use (which includes imaging and freezing), a fully charged battery pack Typical vs. continuous containing 4 batteries provides approximately 4 hours of operation. With a fully charged battery pack, you can scan continuously for approximately 3 hours. 50 Chapter 4 October 2018 Flex Focus 1202 User Guide (BB1756-S)

  • Page 51: Battery Support Setup

    “Connecting Other Equipment” on page 16. Cleaning and Disinfection The cleaning and disinfection instructions for the system in Care and Cleaning apply to the battery pack. Flex Focus 1202 User Guide (BB1756-S) Battery Support...
  • Page 52 52 Chapter 4 October 2018 Flex Focus 1202 User Guide (BB1756-S)

  • Page 53: Remote Control

    Press any key on the remote control to wake it up. Hold down the keys on the remote control for three seconds. AUTO The remote control emits two beeps. Release the keys after the second beep. Flex Focus 1202 User Guide (BB1756-S) Remote Control...

  • Page 54: Sleep

    Screw the battery cap on tight until the arrow points to the area of the battery cap with a large gap between the ridges. When the battery cap is screwed on tight, the remote control is watertight and can be immersed. 54 Chapter 5 October 2018 Flex Focus 1202 User Guide (BB1756-S)

  • Page 55: Cleaning And Disinfection

    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. Flex Focus 1202 User Guide (BB1756-S) Remote Control...
  • Page 56 56 Chapter 5 October 2018 Flex Focus 1202 User Guide (BB1756-S)

  • Page 57: Getting Started

    Chapter 6 Getting Started Getting Started with Flex Focus forms part of this user guide. Flex Focus 1202 User Guide (BB1756-S) Getting Started...
  • Page 58 58 Chapter 6 October 2018 Flex Focus 1202 User Guide (BB1756-S)

  • Page 59: Index

    Index Numerics caution or warning, symbol 9 measurements warning 34 Cautions warning about untracked freehand and measure- about 9 ments 34 center frequency 36 connectors for other equipment accessing 18 accuracy location 18 2D geometric measurements 40 picture 19 3D distance 40 table 20 3D measurements 40 consult instructions for use (symbol) 9...
  • Page 60 ground (earth), additional protective on and off, turning system. See Getting Started. adding 16 ON/Standby button symbol 10 symbol on 10 warning 26 overbalance and tipping height, adjusting. See Getting Started. warning 13 HF electrosurgical equipment, warning 30 warning symbol 9 HistoScanning, connector for 22 pairing remote control 53 image distortion 11...
  • Page 61 standby (symbol) 10 Type BF, defibrillator-proof (symbol) 10 standby button. See Getting Started. system isolation from line voltage 12 UA1225. See battery. malfunction 11 UL (symbol) 10 USB, saving to. See Getting Started. User Documentation CD 5 Technical Data (BZ2100) 5 Thermal Index limit setting 38 VFI (Vector Flow Imaging), warnings about 32...

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