Related Manuals for bk ultrasound Flex Focus 1202
Summary of Contents for bk ultrasound Flex Focus 1202
- Page 1 User Guide Type 1202 Flex Focus Ultrasound Systems English BB1756-Q December 2015 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.
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Page 3: Table Of Contents
Contents Chapter 1 General Information ............7 Essential Performance . - Page 4 Puncture and Brachytherapy........34 3D .
- Page 5 Chapter 6 Getting Started ............59 Index .
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Page 7: General Information
Chapter 1 General Information This user guide is for all versions of the Flex Focus 1202 Ultrasound System (scanner unit and dock) and the optional battery charger station (UA1247) 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 8: Intended Use
OB/GYN • Emergency Medicine • Surgery • Anesthesia • Modes of Operation B-Mode (including Tissue Harmonic imaging) • M-Mode • PWD Mode • CFM Mode • Power Doppler • 8 Chapter 1 December 2015 Flex Focus 1202 User Guide (BB1756-Q) -
Page 9: 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-Q) - Page 10 10 Chapter 1 December 2015 Flex Focus 1202 User Guide (BB1756-Q)
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Page 11: 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 Ultrasound disclaims all responsibility for the operating safety, reliability and performance of the equipment if these symbols and warnings are disregarded in any way. - Page 12 China ROHS 25 Years Environmentally Friendly Use Period for ROHS is 25 Lifetime years. Battery recycle (On battery UA1225.) Recycle used batteries properly. Table 2-1. Symbols and information on the equipment. (continued) 12 Chapter 2 December 2015 Flex Focus 1202 User Guide (BB1756-Q)
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Page 13: Ce Marks On Electrical Devices
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 Ultrasound offers training in how to use the system. Consult your BK representative for information. -
Page 14: Mechanical Safety
Do not try to repair the system yourself. • Contact your BK Ultrasound representative or hospital technician. • WARNING GS-w3a The power supply cord connects the equipment to the line voltage. To isolate the... -
Page 15: Explosion Hazards
The system should be placed at least 25cm (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 Ultrasound service representative. -
Page 16: Electrical Safety
Interference The Flex Focus 1202 Ultrasound System and the optional battery charger station (UA1247) are suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. -
Page 17: Electrical Noise
Caution Inter-c2 Use specified If you use accessories, transducers or cables with the system, other than those specified, equipment increased emission or decreased immunity of the system may result. only Flex Focus 1202 User Guide (BB1756-Q) Safety Information... -
Page 18: 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 18 Chapter 2 December 2015 Flex Focus 1202 User Guide (BB1756-Q) -
Page 19: 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-Q) Safety Information... -
Page 20: 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 2-5. 20 Chapter 2 December 2015 Flex Focus 1202 User Guide (BB1756-Q) - Page 21 Ground connector Push tab to release fuses. Click new ones in place Figure 2-3. Connectors in the neck of the Flex Focus system. Flex Focus 1202 User Guide (BB1756-Q) Safety Information...
- Page 22 DVI - digital output that gives the best image quality. VGA – this analog output from the DVI connector gives slightly poorer image quality than the digital DVI output. 22 Chapter 2 December 2015 Flex Focus 1202 User Guide (BB1756-Q)
- Page 23 BNC (female) to Phone (male) Phono RCA (Composite) 7-pin S-video to Composite 2 connectors 7-pin S-video to (S-video and composite) S-video/Composite (same view on both connectors) Table 2-4. Video connectors and adapters. Flex Focus 1202 User Guide (BB1756-Q) Safety Information...
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Page 24: 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. 24 Chapter 2 December 2015 Flex Focus 1202 User Guide (BB1756-Q) -
Page 25: Emc Requirements
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 21). Flex Focus 1202 User Guide (BB1756-Q) Safety Information... - Page 26 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. 26 Chapter 2 December 2015 Flex Focus 1202 User Guide (BB1756-Q)
- Page 27 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.
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Page 28: 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 Ultrasound representative. WARNING ME-w2 An approved printer, specified in the Product Data sheet, can be connected to the internal Printers and auxiliary power outlet on the system. -
Page 29: Battery Support System
BK Medical equipment for charging. Must be recycled or disposed of properly. Recycle facilities may not be available in all areas. Charge before use. To re-purchase contact your local BK representative. Can be found on www.bkultrasound.com Flex Focus 1202 User Guide (BB1756-Q) Safety Information... -
Page 30: If The System Will Not Start
The remote control uses short wave radio waves to communicate with the system. WARNING RC-w2 The remote control is active at a distance of at least 10 meters from the system, even if the system is in a different room. 30 Chapter 2 December 2015 Flex Focus 1202 User Guide (BB1756-Q) -
Page 31: Computer Security
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 Ultrasound does not take any responsibility for computer viruses from the network that may infect the Flex Focus. -
Page 32: During An Examination
Do not leave transducers in contact with the patient when using HF electrosurgical Electrical equipment. burns BK Ultrasound 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 33: Verifying The Transducer Type
Before you start to image, verify that the type number on the transducer matches the Type number displayed on the monitor. In case of any inconsistency, stop imaging, turn off the number system, and contact your local BK Ultrasound representative. displayed must match number on... -
Page 34: Puncture And Brachytherapy
If the number is incorrect, the puncture puncture line on the monitor may not correspond to the true puncture path in the tissue. guide type number 34 Chapter 2 December 2015 Flex Focus 1202 User Guide (BB1756-Q) - Page 35 WARNING B-w4 To avoid harming the patient, check the needle alignment (and recalibrate if necessary) before each use. Pay particular care to the following safety issues when operating the 3D system. Flex Focus 1202 User Guide (BB1756-Q) Safety Information...
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Page 36: Picture In Picture
Prudent Use WARNING AO-w1 To avoid tissue damage, always keep the exposure level (the acoustic output level and the Exposure exposure time) as low as possible. level 36 Chapter 2 December 2015 Flex Focus 1202 User Guide (BB1756-Q) -
Page 37: Monitor Display
SPTA 720mW/cm , the maximum Mechanical Index (MI) must be 1.9, and the maximum Thermal Index (TI) must be 6. All BK Ultrasound transducers for use with the Flex Focus 1202 Ultrasound System are Track 3. Monitor Display The Mechanical Index (MI) and Thermal Index (TI) can be viewed in all imaging modes. -
Page 38: Acoustic Output Measurement
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 38 Chapter 2 December 2015 Flex Focus 1202 User Guide (BB1756-Q) -
Page 39: Functions Affecting Acoustic Output
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). Flex Focus 1202 User Guide (BB1756-Q) Safety Information... -
Page 40: Clinical Measurements: Ranges And Accuracies
Clinical Measurements: Ranges and Accuracies This section states the accuracies for measurements made using the BK Ultrasound 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 41: Geometric Measurements
Geometric Measurements 2D Measurements The geometric measurements performed by BK Ultrasound ultrasound systems are distance, perimeter, area and ellipsoid volume. The accuracy of these measurements is influenced by the following factors: Transducer geometry •... -
Page 42: Time Measurements
Collateral standard: Electromagnetic Compatibility-Requirements and tests. EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance. Collateral standard: Electromagnetic Compatibil- ity-Requirements and tests. 42 Chapter 2 December 2015 Flex Focus 1202 User Guide (BB1756-Q) - Page 43 Diagnostic Ultrasound Equipment. AIUM/NEMA. 2004. [11] Medical Ultrasound Safety. Second edition. AIUM. 2009. [12] ALARA Training Program. Ultrasound III Training. BK Ultrasound. 1993. [13] Bioeffects considerations for the safety of diagnostic ultrasound. Journal of Ultrasound in Medicine, Vol. 7, No. 9 (supplement). September 1988.
- Page 44 44 Chapter 2 December 2015 Flex Focus 1202 User Guide (BB1756-Q)
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Page 45: 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-Q) Adjusting the System... - Page 46 46 Chapter 3 December 2015 Flex Focus 1202 User Guide (BB1756-Q)
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Page 47: Battery Support
(UA1247), you can always have charged batteries ready to insert when needed. 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-Q) Battery Support... -
Page 48: Power Supply
Display Power supply Push tab to release fuses. Click new ones in place. Figure 4-2. The back of the battery pack. 48 Chapter 4 December 2015 Flex Focus 1202 User Guide (BB1756-Q) -
Page 49: Charging The Batteries
Figure 4-3. Battery level shown as % or as time available. A message appears on the monitor (Fig 4-8) when a battery reaches the end of its lifespan and needs replacing. For information about the disposal of depleted batteries, see page 29. Flex Focus 1202 User Guide (BB1756-Q) Battery Support... -
Page 50: 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 • 50 Chapter 4 December 2015 Flex Focus 1202 User Guide (BB1756-Q) -
Page 51: 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-Q) Battery Support... -
Page 52: 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. 52 Chapter 4 December 2015 Flex Focus 1202 User Guide (BB1756-Q) -
Page 53: Battery Support Setup
It takes approximately 2 hours and 45 minutes hours to recharge 4 batteries in the Charge time station. Flex Focus 1202 User Guide (BB1756-Q) Battery Support... -
Page 54: Recharging A Battery In The Battery Charger Station
NOTE: “Battery Support System” on page 29. Cleaning and Disinfection The cleaning and disinfection instructions for the system in Care, Cleaning & Safety apply to the battery charger station. 54 Chapter 4 December 2015 Flex Focus 1202 User Guide (BB1756-Q) -
Page 55: 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-Q) Remote Control... -
Page 56: 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. 56 Chapter 5 December 2015 Flex Focus 1202 User Guide (BB1756-Q) -
Page 57: 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-Q) Remote Control... - Page 58 58 Chapter 5 December 2015 Flex Focus 1202 User Guide (BB1756-Q)
- Page 59 Chapter 6 Getting Started Getting Started with Flex Focus forms part of this user guide. Flex Focus 1202 User Guide (BB1756-Q) Getting Started...
- Page 60 60 Chapter 6 December 2015 Flex Focus 1202 User Guide (BB1756-Q)
- Page 61 Index brachytherapy Numerics warning about checking matrix 35 warning about user-defined matrixes 35 measurements warning 36 warning to verify matrix type and coordinates 35 warning about untracked freehand and measure- brightness, adjusting monitor. See Getting Started. ments 36 caution or warning, symbol 11 accuracy Cautions 2D geometric measurements 41...
- Page 62 exposure level 36 responsibility for 19 extension cord, do not use 18 noise electrical 17 EMC 17 fetal imaging, acoustic output settings for 40 non-medical equipment, connecting to system 28 fuses not watertight (symbol) 12 replacing 21 replacing (battery pack) 48 on and off, turning system.
- Page 63 screen controls, basic, overview. See Getting Started. Type B (symbol) 12 sealing (symbol) 12 Type BF (symbol) 12 security, network. See network security. Type BF, defibrillator-proof (symbol) 12 service and repair 31 Specified Radio Equipment, symbol (Japan) 12 standby (symbol) 12 UA1225.
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