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Flex Focus 1202 User Guide

(BB1756-Q)

General Information

Indications for Use

The system is intended for use by qualified physicians for ultrasound evaluation.
Specific clinical applications and exam types include:

•

Abdominal

•

Cardiac (not for direct use on the heart)

•

Fetal

•

Intraoperative

•

Intraoperative Neurological

•

Musculoskeletal Conventional

•

Musculoskeletal Superficial

•

Neonatal Cephalic

•

Obstetrics

•

Pediatric

•

Peripheral Vascular

•

Small Organ

•

Transrectal

•

Transurethral

•

Transvaginal

Indicated uses are different for different transducers. The Product Data sheet for the
system contains a table listing the indicated uses for each transducer that can be used
with the system.

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.

Summary of Contents for Flex Focus 1202

Page 1: ...English BB1756 Q December 2015 For Professional Users Only User Guide Type 1202 Flex Focus Ultrasound Systems ...

Page 2: ...cal TO CONDUCT SUFFICIENT TESTING TO DETERMINE THAT THE SOFTWARE IS SUITABLE FOR USE EXPORT RESTRICTIONS You acknowledge that Windows XP Embedded is of US origin You agree to comply with all applicable international and national laws that apply to Windows XP Embedded including the U S Export Administration Regulations as well as end user end use and country destination restrictions issued by U S a...

Page 3: ...rference 17 RF Radio Frequency Interference 17 Installation 18 Connecting Other Equipment 18 Network Connection 19 Network Security 19 Network Printing 19 Connectors 20 HistoScanning 24 Using the System with a Lithotriptor 24 EMC Requirements 25 Isolation of DICOM Network 25 Wireless Network Wi Fi 25 Medical Equipment 28 Non Medical Equipment 28 Battery Support System 29 If the System Will Not Sta...

Page 4: ...port 47 Before You Start 47 Imaging with Battery Support 47 Battery Pack Location 47 Power Supply 48 Plugging in the System 48 Charging the Batteries 49 Battery Status 49 Information Available on the Monitor 49 Information Available on Battery Pack 50 Power Save Mode 51 Changing or Replacing a Battery 52 Battery Life 52 Battery Support Setup 53 Connectors 53 Cleaning and Disinfection 53 Battery Ch...

Page 5: ...5 Chapter 6 Getting Started 59 Index 61 ...

Page 6: ...6 ...

Page 7: ...cribed in the user manuals constitutes improper use Essential Performance The system can provide 2D and 3D ultrasound echo and flow imaging systems as an aid in diagnosis data processing and transfer and guidance of puncture and biopsy Document Information System User Guide Introductory information safety information getting started Getting Started User interface basic operating instructions Note ...

Page 8: ... related indications MI TIS TIB etc are displayed as worst case values The system does not generate unintended or excessive ultrasound output or transducer surface temperature There is no unintended or uncontrolled motion of transducer assemblies intended for intra corporeal use Intended Use The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body data proc...

Page 9: ...l Musculoskeletal Conventional Musculoskeletal Superficial Neonatal Cephalic Obstetrics Pediatric Peripheral Vascular Small Organ Transrectal Transurethral Transvaginal Indicated uses are different for different transducers The Product Data sheet for the system contains a table listing the indicated uses for each transducer that can be used with the system Contraindications The Flex Focus 1202 ult...

Page 10: ...10 Chapter 1 December 2015 Flex Focus 1202 User Guide BB1756 Q ...

Page 11: ... 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 WARNING Warnings contain information that is important for avoiding personal injury Caution Cautions contain information and instru...

Page 12: ...ck of scanner unit used to turn system on and off Not watertight Plug may not be immersed unless it is covered with a special watertight plug cover ESD electrostatic discharge Do not touch pins in connectors with this symbol unless you follow ESD precautionary procedures Specified Radio Equipment On remote control UA1237 This equipment conforms to Japanese Radio Law regulations concerning frequenc...

Page 13: ...de the mobile battery keyboard dock internally powered devices of EN IEC 60601 1 They also comply with UL 60601 1 4 and CSA C22 2 No 601 1 M90 5 They fulfill the requirements for dust protection IP20 for ordinary equipment specified in EN 60529 1 Internally Powered On the battery pack The text Internally powered or 100V 60Hz 100V 230V 50 Hz indicates that the system can also use batteries as a pow...

Page 14: ...WARNING GS w3a The power supply cord connects the equipment to the line voltage To isolate the equipment you must unplug the power supply cord from the power source and for systems that include the mobile battery keyboard dock remove the batteries from the battery pack Do this before you try to make any repairs to the system Spilled liquids Caution S c2 The keyboard panel of the ultrasound system ...

Page 15: ...it WARNING MS w3 To avoid personal injury or damage to the system if you handle the scanner unit by itself make sure you have a firm grip so that you do not drop it Note that it may be hot Don t push too hard WARNING MS w4 Toavoidinjuryandequipmentdamage donotpushthesystemtoohard especiallywhen you roll the system over an uneven surface Applying excessive force near the top could cause the system ...

Page 16: ... 230V and you believe the leakage current would be within the UL limit if you were using 120V power to the equipment must come from an installation or supply unit with a center tapped 240V single phase circuit This will make sure that chassis leakage current during single fault condition fulfills the requirements specified in UL60601 1 4 limit of 300μA If power is not supplied in the way specified...

Page 17: ...for the purpose of its operation The transducers are very sensitive to frequencies within their signal frequency range 0 3MHz to 80MHz Therefore RF equipment operating in this frequency range can affect the ultrasound image However if disturbances occur they will appear as white lines in the ultrasound picture and cannot be confused with physiological signals Electrical noise WARNING EN w1 Electri...

Page 18: ...n protocol on top of TCP IP Installation safety requirement WARNING I w1 Toensuresafeperformance aqualifiedelectricianorhospitalsafetypersonnelmustverify that the equipment is correctly installed and that it complies with the following safety requirements Use only the original power supply cord In the USA this is fitted with a hospital grade three prong grounded power plug Never try to remove or c...

Page 19: ...y a change in the network configuration If the applicable network connection does not meet the required characteristics of the IT network the following hazardous situations may occur Corrupt patient data due to network errors see Warning Exam w3 on page 32 System is unable to use the network due to faulty or overloaded network see Warning GS w1 on page 13 System overloads the network causing other...

Page 20: ... pack the external power is plugged directly into the battery pack on the system stand The system is then connected to the power source through a connection from the battery pack to the 12 V plug in the neck see Systems with battery pack in Fig 2 3 Systems with a battery pack are delivered with a power cord in the neck this is an auxiliary power source for an approved printer When there is no prin...

Page 21: ...t for approved printers only Systems without battery pack Systems with battery pack 12 V from battery pack goes in to power the system here For systems without printer auxiliary power cord plug for approved printers only is placed here for future use Power supply cord goes here Push tab to release fuses Click new ones in place Ground connector ...

Page 22: ...utput from the DVI connector gives slightly poorer image quality than the digital DVI output Symbol Connector Additional Information DVI I DVI I Connector for auxiliary DVI or VGA monitor Composite S video In 7 pin S video connector see Table 2 3 for pin layout that can be adapted to a composite video input see Table 2 4 Composite S video Out 7 pin S video connector see Table 2 3 for pin layout th...

Page 23: ...ou which adapters can be used Table 2 4 Video connectors and adapters Cable Connectors in order of preference Adapter Flex Focus Connector DVI D Not needed DVI I 15 pin VGA DVI to VGA adapter 2 views DVI I 4 pins S video Not needed BNC Composite 7 pin S video to Composite BNC female to Phone male Phono RCA Composite 7 pin S video to Composite 2 connectors S video and composite same view on both co...

Page 24: ...guidelines in EN 60601 1 1 7 Safety requirements for medical electrical systems You must have a license installed to use a lithotriptor with the system You must always follow instructions in the manufacturer s user guide for the lithotriptor Power Connections Do NOT connect a lithotriptor to the auxiliary power outlet Plug the system and the lithotriptor directly into independent wall power outlet...

Page 25: ...lvanically connected to a computer network DICOM that has not been isolated If the network is not isolated the system must be connected via a network isolator DP0925 Wireless Network Wi Fi The system can be connected to a wireless network for printing and archiving data This requires the optional wireless license for the system and a Wi Fi adapter that is supplied by BK Medical when you buy this o...

Page 26: ...em s Wi Fi for printing and archiving To use Wi Fi on the system you need to install a license When you have installed the license a Wi Fi logo is visible on the lower right of the main screen 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 Caution ...

Page 27: ...up correctly See Warning GS w1 on page 13 NOTE The system only supports one network at a time If the system loses connection with the network while transmitting for example because it is moved out of range of the network during a transmission the pending data is stored temporarily and re transmitted when the connection is re established For information on saving and printing using the DICOM protoc...

Page 28: ...iliary power outlet on this BK Ultrasound system for any other 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 from the power source WARNING NME w1 Follow the guidelines in EN 60601 1 1 7 Safety requirements for medical electrical systems If you connect non medica...

Page 29: ...sure proper ventilation and avoid overheating keep both ends of the battery pack or optional battery charger station UA1247 clear WARNING BS w2 To prevent damage to the equipment use only the UA1225 battery set check the number on the battery set before you insert it into the battery pack or recharge in the optional battery charger station UA1247 WARNING BS w3 The batteries in the battery pack or ...

Page 30: ...ure resets the safety feature and should resolve the issue If the problem persists for example the fan does not start contact your BK representative Touch Screen NOTE This information applies to the Flex Focus 700 order no 1202 3 with touch screen When using sterile covers available in some hospitals and clinics make sure only the area with keyboard and screen controls are covered No cover is nece...

Page 31: ...ium USB device or DVD to make sure that it is virus free before you connect it to the system Authorized personnel WARNING SR w1 Service and repair of BK Medical electromedical equipment must be carried out only by the manufacturer or its authorized representatives BK Medical reserves the right to disclaim all responsibility including but not limited to responsibility for the operating safety relia...

Page 32: ...medicaldiagnosticandmonitoring equipment To avoid this freeze the image when the transducer is not used for imaging Creutzfeldt Jakob disease WARNING C J w1 Donotuseatransducerforneurosurgicalapplicationsifthepatientissuspectedofhaving Creutzfeldt Jakob disease If a neurosurgical transducer has been used on a patient suspected of or diagnosed as being Creutzfeldt Jakob positive the transducer must...

Page 33: ...e area of the smaller loop Using Doppler curves WARNING M w2 Drawings of Doppler curves manual and automatic are meant as tools for positioning cursors so that measurements based on the curves can be calculated automatically The system has no facilities for checking whether the automatic measurements are reasonable Curves drawn on very noisy spectra may lead to misplacement of measurement cursors ...

Page 34: ...asurement may not be precise Doppler spectrum aliasing WARNING VFI w6 Check to make sure that the Doppler spectrum does not alias Otherwise the real time volume flow measurement may not be precise Verify transducer type number WARNING P w1 Before you start imaging verify that the type number or name of the transducer and the type number or description of the puncture attachment you are using match...

Page 35: ...3 Changes you make to the offset of a programmable puncture guide or brachy matrix will affect ALL programmable puncture guides and brachy matrixes This could lead to incorrect puncture lines or matrix positions for a different guide than the one you wanted to change Verify matrix type and coordinates WARNING B w1 Verifythatthematrixtypeandcoordinatesdisplayedonthemonitoragreewiththeactual matrix ...

Page 36: ...ate quantitative assessment Before you perform a calculation make sure that all necessary calibrations and measurements are made If you suspect that the 3D system s calibration is inaccurate that is the measurements are not as expected contact your local BK service representative to check and confirm the system s proper operation Untracked freehand WARNING 3D w2 You cannot make accurate measuremen...

Page 37: ...ons of the parameters refer to the Food and Drug Administration FDA Guide 8 as well as EN 60601 2 37 3 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment and AIUM NEMA standards 9 10 The routes or tracks available for clearance by the FDA are well defined Track 3 is for diagnostic ultrasound systems that follow the Output Display Standard 10 Under Trac...

Page 38: ...Output Measurement All values are measured in water according to the EN 60601 2 37 3 and AIUM NEMA display standards 9 10 For some of the acoustic parameters an estimated in situ derated value is given This is derived assuming a tissue attenuation of 0 3 dB cm MHz when the estimated in situ derated value I is described by the following equation I formula where the variables are defined in the tabl...

Page 39: ...When necessary the system will reduce the output voltage and or PRF pulse repetition frequency to the transducer to comply with requirements Some of the system functions can affect the acoustic output as listed here Instructions for using these functions are given in the relevant sections of this user guide Sizing functions such as ROI region of interest in general smaller size results in higher a...

Page 40: ...taken into account in this section For example The sound velocity may vary from approximately 1450 m s in fatty tissue to 1585 m s in muscle This can in simple cases give rise to errors of up to 6 for linear measurements This inaccuracy may be further increased by refraction occurring at tissue boundaries The user can introduce errors when using approximate formulas when positioning the system s c...

Page 41: ...he slices and their relative orientation To obtain the accuracies listed in the table in the Technical Data BZ2100 you must ensure that the calculation is based on contributions from at least 10 slices for very regular shapes and more for irregular shapes It must also be possible to discriminate the boundary of the object from the surrounding tissue Volume accuracy The volume accuracy in the table...

Page 42: ...ponding to an overload condition of the measurement system References 1 EN 60529 1991 A1 2000 Specification for degrees of protection provided by enclosures IP code 2 EN IEC 60601 1 1990 A1 1993 A2 1995 A13 1996 Medical electrical equipment Part 1 General requirements for safety EN IEC 60601 1 2006 3rd Ed Medical electrical equipment Part 1 General requirements for basic safety and essential perfo...

Page 43: ...echanical Acoustic Output Indices on 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 14 The safety of diagnostic ultrasound The British In...

Page 44: ...44 Chapter 2 December 2015 Flex Focus 1202 User Guide BB1756 Q ...

Page 45: ...is registered when you remove your finger from the screen so don t hold your finger down and try to press hard if you think nothing is happening The touch screen is recalibrated Adjusting the Touch Screen Viewing the image and other information on the monitor can be affected by lighting in the room To avoid glare you can tilt the monitor from its upright position see Getting Started with Flex Focu...

Page 46: ...46 Chapter 3 December 2015 Flex Focus 1202 User Guide BB1756 Q ...

Page 47: ...he battery pack s operation see Flex Focus Advanced User Guide Imaging with Battery Support This is an overview of the steps for using the battery support system to power the imaging system 1 Make sure the batteries are charged If not plug in the imaging system to use it or to change the batteries 2 Turn on the system 3 When the batteries run down you do not have to turn off the imaging system Eit...

Page 48: ... the system before inserting any batteries On systems with a battery pack the power supply cord plugs into the battery pack instead of the neck of the system The auxiliary power outlet to be used only for approved printers is in the neck of the system Figure 4 2 The back of the battery pack Battery pack Power supply Display Push tab to release fuses Click new ones in place ...

Page 49: ...tteries or 4 batteries This is true at all times May need to discharge and recharge fully If the Batteries Appear Not to Charge to 100 After repeated use the batteries may require a full discharge full charge and full discharge in order to recalibrate the electronic fuel gauge so that the indication of how much charge is left in the battery is accurate Battery Status While the system is operating ...

Page 50: ...n you can see LED indicator lights showing the status of each individual battery see Fig 4 4 The battery numbers refer to the position of the battery in the pack and are relevant for system messages about battery status Figure 4 4 Front of a battery pack containing 4 batteries Low Battery When battery capacity is very low The system beeps A message appears on the monitor The on screen battery indi...

Page 51: ...ttery reaches the critical level the system shuts down immediately To set the level for the critical low battery message see Flex Focus Advanced User Guide AC power LED When the system is plugged in the display on the battery box is lit and the AC Power indicator light normally hidden by the door on the battery pack is lit See Fig 4 4 Power Save Mode Power save mode With power save mode you can co...

Page 52: ...attery disposal warning BS 4 in Battery Support System on page 29 Battery Life The battery UA1225 has a built in check to indicate how much charge is available in the battery Light diodes mark when there is 25 50 75 or 100 charge on the battery To check the charge on a battery UA1225 1 Press the round circle next to the word Push on the battery 2 The light diodes indicate the charge level 25 charg...

Page 53: ... operation of the battery pack see Flex Focus Advanced User Guide Connectors PC connectors for connecting the system to other equipment such as approved printers and video equipment are located in the neck of the system For information about the connectors to use see Connecting Other Equipment on page 18 Cleaning and Disinfection The cleaning and disinfection instructions for the system in Care Cl...

Page 54: ...s the latch on the back side of the battery charger station to open the cover 2 Slide drained or new batteries into the empty slots 3 When a battery is fully charged pull its tab and slide it completely out of the frame NOTE See the battery disposal warning BS 4 in Battery Support System on page 29 NOTE See the warning about using only authorized UA1225 batteries BS 2 in Battery Support System on ...

Page 55: ...ol for three seconds The remote control emits two beeps 4 Release the keys after the second beep Blue diode Blinks to show remote control is awake Toggle imaging modes B Color Doppler B User definable Adjust gain for one mode only the first in this list that is active Doppler Color Power B mode Start Stop imaging Capture an image to the system hard disk or print it User definable Battery level Bli...

Page 56: ...ystem Therefore it is important to keep track of which remote control is paired with which system Before each use verify that the remote control is working correctly Sleep If the remote control is not used or moved for 5 minutes it goes to sleep to save battery power To wake it up press any key Mouse Function You can use the remote control as an air tracking mouse to operate controls on the system...

Page 57: ...ee Care and Cleaning Remote Control WARNING RC w1 The remote control requires surface disinfection or sterilization as a minimum The inside battery compartment cannot be classified as disinfected or sterile Follow procedures established for your hospital clinic or institution to avoid cross contamination when inserting or removing batteries ...

Page 58: ...58 Chapter 5 December 2015 Flex Focus 1202 User Guide BB1756 Q ...

Page 59: ...Flex Focus 1202 User Guide BB1756 Q GettingStarted 59 Chapter 6 Getting Started Getting Started with Flex Focus forms part of this user guide ...

Page 60: ...60 Chapter 6 December 2015 Flex Focus 1202 User Guide BB1756 Q ...

Page 61: ...nectors 53 internally powered 13 must use 2 or 4 batteries 49 power save mode 51 replacing fuses 48 biopsy See puncture brachytherapy warning about checking matrix 35 warning about user defined matrixes 35 warning to verify matrix type and coordinates 35 brightness adjusting monitor See Getting Started C caution or warning symbol 11 Cautions about 11 CE marks 13 center frequency 38 connectors for ...

Page 62: ...19 network security guidelines 19 responsibility for 19 noise electrical 17 EMC 17 non medical equipment connecting to system 28 not watertight symbol 12 O on and off turning system See Getting Started ON Standby button symbol on 12 warning 28 overbalance and tipping warning 15 warning symbol 11 P pairing remote control 55 patient ID importance of entering 32 verifying 32 Peak Rarefactional Pressu...

Page 63: ...safety 31 transperineal biopsy warning about checking matrix 35 warning about user defined matrixes 35 warning to verify matrix type and coordinates 35 turning system off and on See Getting Started Type B non isolated transducers warning about 31 Type B symbol 12 Type BF symbol 12 Type BF defibrillator proof symbol 12 U UA1225 See battery UA1247 See battery charger station UL symbol 12 USB saving ...

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