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Flex Focus Ultrasound Systems

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1. Figure 4 1 System with battery support in the backpack Power Supply Plugging in the System NOTE Always plug in 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 Display Power supply Push tab to release fuses Click new ones in place Figure 4 2 The back of the battery pack 42 Chapter 4 February 2014 Flex Focus 1202 User Guide BB1756 M Charging the Batteries Batteries automatically begin charging when the system is plugged into the power outlet Charger Batteries can also be charged in the battery charger station where it takes station approximately 2 hours and 45 minutes to recharge 4 batteries See Battery Charger Station UA1247 on page 47 The battery charger station is optional see Accessories in the Flex FocusProduct Data sheet Charging New batteries are typically at a 50 charge There is a built in battery check on new batteries batteries for the battery pack 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 Caution A minimum of 2 batteries is required to run the system on battery power The system can only run on either 2 batteries or 4 batterie
2. Fig 2 2 Connector cover 0 i U mm Unscrew here to remove __ connector cover Figure 2 2 Flex Focus connector cover Some connectors are used by the system Do not use connectors that are not labelled in Fig 2 3 For systems with a battery 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 Flex Focus 1202 User Guide BB1756 M Safety Information 15 with a power cord in the neck this is an auxiliary power source for an approved printer When there is no printer on the system the plug on the auxiliary power cord is stored in the empty space next to the 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 Systems without battery pack Systems with battery pack Auxiliary power outlet For systems without printer for approved printers auxiliary power cord plug Power supply only for approved printers only is cord goes here placed here for future use 12 from battery pack goes in to power the Y here Ground connector Push tab to release L L fuses Click new A ones in place i sy Figure 2 3 Connectors in the n
3. 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 A Caution You must perform a virus check on any external storage medium USB device or rea DVD to make sure that it is virus free before you connect it to the system ec external media Service and Repair JX WARNING SR 1 Authorized Service and repair of BK Medical electromedical equipment must be carried out only by personnel 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 reliability and performance of equipment serviced or repaired by other parties After service or repairs have been carried out a qualified electrician or hospital technician should verify the safety of all equipment Transducers WARNING T 1 Electrical The transducer sockets contain terminals with 5V Do not touch the patient while you are shock touching an uncovered socket J WARNING T 2 Type B When using Type B non isolated transducers carefully check all electrical equipment transducers Within the patient area Also consider using additional protective grounding A WARNING T 3 Electrical Do not leave transducers in contact with the patient when using HF electro
4. BB1756 M Specifications and Indications for Use 55 56 Chapter 7 February 2014 Flex Focus 1202 User Guide BB1756 M Index Numerics 3D measurements warning 30 warning about untracked freehand and measure ments 30 A accuracy 2D geometric measurements 36 3D distance 36 3D measurements 36 3D volume 36 clinical measurements explained 34 Doppler measurements 37 time difference measurements 36 acoustic output default 34 factors affecting 33 34 measurement 33 ALARA principle 32 34 auxiliary power outlet 23 B batteries and battery pack battery disposal 24 battery life 46 changing a battery 46 charge time for batteries 47 charging batteries 43 48 charging new batteries 43 checking the charge on a battery 46 recycle symbol 8 recycling 8 24 replacing a battery 46 troubleshooting 25 use of authorized UA1225 battery set 24 warnings 24 waste symbol 8 batteries and remote control battery level 49 replacing 50 battery charger station cleaning and disinfection 48 51 warnings 24 battery pack battery status 43 cleaning and disinfection 47 configuring and customizing See Advanced User Guide 41 connectors 47 internally powered 8 must use 2 or 4 batteries 43 power save mode 45 replacing fuses 42 biopsy See puncture brachytherapy warning about checking matrix 30 warning about user defined matrixes 30 warning to verify matrix type and coordinates 30 brightness adjusting monitor See Getting Started C
5. L leakage current 11 23 liquids do not spill on system 10 lithotriptor connecting system to 19 power connections 19 special considerations 19 using system with 19 warning 19 M magnetic shielding 12 manufacturer symbol 7 measurements Doppler warnings 28 medical equipment connecting to system 23 MI Mechanical Index and ALARA 32 formula 32 Mini Bluetooth Adapter 49 monitor brightness adjusting See Getting Started N network guidelines 15 isolator 20 printing protocols for 15 network security guidelines 15 responsibility for 15 noise electrical 12 EMC 13 non medical equipment connecting to system 23 not watertight symbol 8 0 on and off turning system See Getting Started ON Standby button symbol on 8 warning 23 overbalance and tipping warning 11 warning symbol 7 p pairing remote control 49 patient ID importance of entering 27 verifying 27 Peak Rarefactional Pressure 32 potential equalization symbol 8 terminal 14 power cord keep clean and dry 13 original 14 power plug 13 power strip do not use 11 power supply cord accidental disconnection 13 use original 13 prostate transperineal biopsy warning about checking matrix 30 warning about user defined matrixes 30 warning to verify matrix type and coordinates 30 prudent use 31 puncture warning about changing offset of programmable puncture guides or brachy matrixes 29 warning to verify puncture guide number 29 warning
6. Measurements Ranges and Accuracies 00 eee eeee 34 Geometric Measurements nunnana c cece e eens 36 Time Measurement a i503 ienas NR T ER R ER RC Ihe nam aceces eens 36 Doppler Measurements cians vee cael edt cee kk 37 References R e RE ARE RR T A A een ees a 37 Adjusting the System sss ss ss s e s s s s s e s e s e s e e e e ennenen 39 Calibrating the Touch Screen Alignment 2 eee cece eee 39 Adjusting the Touch Screen 39 Battery Support ssssessssesessssesessosesessoesossoseseseosesoseseeo 41 Before You stat TTT 4 Imaging with Battery Support 4 9h os See weed rererere 4 Battery Pack Loca x 00 R K cee tulle Cie wad RRR R E R K Ga 4 BOWER Supply chi Ra OOT uid aoe og R AAE the eh Ghd aden ea ie as 42 Plugging in the System cada dneeueveees Ga tagueeeaee ad 42 Charging the Batteries e060 es was eb bee eee Sets tea tee cea 43 ST e Te 43 Information Available on the Monitor 000 0 c eee eee 43 Information Available on Battery Pack 44 Power Save Modere re evel ovat ee RRR Svat ates Madiwwe ees 45 Changing or Replacing a Battery c 4 s0d ee ce haa ae eek vs 46 aeae an Ray cree rani Are ate hay EE Re cals AR AT 46 Battery Support Setup pA itd eee es eee teGaeees oie owe Ree ESS 47 Connectors 2 eee te a es Se Dae eek ieee i ART da Bite Metta a 47 Cleaning and DisinieChOns 3c enue bt2d newer ganed edad teow dameteed 47 Battery Charger Station UAI247 oc ccc nce soseee eee ss bee ne ees wee
7. after the critical low battery threshold is met and the system has shut down To set the level for the low battery message see Flex Focus Advanced User Guide Critical Low Battery The setting for critical low battery is set to 3 minutes by default When the battery 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 When the system is plugged in the display on the battery box is lit and the AC Power LED indicator light normally hidden by the door on the battery pack is lit See Fig 4 4 Power Save Mode Power save With power save mode you can conserve battery power and reduce energy mode consumption when the system is not in active use A message appears on the monitor to notify you when the system is about to go into power save mode The scanner is about to go into power save mode Figure 4 6 Power save message To exit power save mode and restore the system to normal power you can do one of the following e Press a key on the keyboard e Press the transducer button e Move the trackball To enable and configure power save mode see Flex Focus Advanced User Guide Flex Focus 1202 User Guide BB1756 M Battery Support 45 Changing or Replacing a Battery Whether you are changing a battery that is low on charge or replacing a dead battery you follow the same steps for removing and inserting batteries in the
8. battery pack A message on the monitor will alert you to the need to change batteries NOTE You must always replace 2 or 4 batteries at a time To change batteries 1 Plug in the power cord 2 Press the latch on the back side of the battery pack to open the cover 3 To disengage a battery pull its tab and slide it completely out of the frame 4 Slide charged batteries into the free slots 5 Unplug the power cord NOTE See the battery disposal warning BS 4 in Battery Support System on page 24 Battery Life Typical vs continuous 46 Chapter 4 use 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 e 25 charge 25 is lit e 50 charge 25 and 50 are lit e 75 charge 25 50 and 75 are lit e 100 25 50 75 and 100 are lit e No diodes are lit when the battery is flat Figure 4 7 The built in check button and diodes on the battery UA1225 With typical use which includes imaging and freezing a fully charged battery pack containing 4 batteries provides approximately 4 hours of operation With a fully charged battery pack you can scan continuously for approximately 3 hours February 2014 Flex Focus 1202 User Guide BB
9. specific network When you turn on the system an attempt is made to reconnect to the network that the system was connected to before it was turned off a ii Weak vs strong signal The bars in the Wi Fi logo represents the signal strength The more lit bars in the logo the stronger the signal G When the system is not connected to a wireless network the Wi Fi logo has a red X over it No wireless connection Flex Focus 1202 User Guide BB1756 M Safety Information 21 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 Additional characteristics Frequency band 2 412 2 4835 GHz Data throughput Max 150 Mbps Latency Depends on network setup Integrity Full integrity of archiving operations Security characteristics Support for WEP WPA and WPA2 encryption Enterprise encryption 802 1 requires assistance from an authorized BK Medical technician Spectrum management None required When you transmit data over a wireless network some special considerations apply In particular the network connections must be set up correctly See Warning GS 1 on page 9 NOTE The system only supports one network at a time If the system loses connection with the network
10. time displayed is an estimate based on typical use for continuous imaging the actual time available will be less than indicated on the display When the door to the battery pack is open 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 Batteries Door latch Pull tabs AC power Battery indicator light indicator light y Indl ig Figure 4 4 Front of a battery pack containing 4 batteries LED Indicator Light Battery Status Green light Charged Red light Battery level is below 33 Off No battery in slot or battery is flat Low Battery When battery capacity is very low e The system beeps e A message appears on the monitor e The on screen battery indicator turns red e The display on the battery box blinks regularly February 2014 Flex Focus 1202 User Guide BB1756 M Battery level is low After approximately 4 minutes 13 18 58 the scanner will shut down Figure 4 5 Low battery message The low battery message informs you that the battery level is low and that the system will shut down when the system monitor clock matches the time stamp in the message shown here as 13 18 58 The display on the battery box begins to blink regularly when the low battery threshold is met and it continues to blink even
11. total leakage current for all the connected equipment can exceed the limits specified in EN IEC 60601 1 2 Part 1 General requirements for safety e the impedance of the ground connection could exceed the limits specified in EN IEC 60601 1 WARNING ES 2 When the equipment is used with 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 300 pA If power is not supplied in the way specified the leakage current can be as high as 500 pA the limit specified in EN IEC 60601 1 2 Part 1 General requirements for safety WARNING ES 3 You risk electrical shock if you try to get inside the equipment other than opening a cover to access connectors or batteries described in the user guide Do not allow anyone but qualified service personnel to service the equipment Flex Focus 1202 User Guide BB1756 M Safety Information 11 ESD Training The ESD Symbol C Anyone using the equipment must be able to recognize the ESD symbol and understand how to take the necessary precautionary procedures as described in the caution below x eee Caution Do not touch pins in connectors that have the ESD symbol drs Do not connect anything to them
12. trouble activating the correct screen control when you tap it you may need to recalibrate the alignment This is simple to do To align the touch screen 1 Click the Keyboard tab 2 Click Alt then C 3 Follow the directions on the screen You will have to tap each cross that appears and then confirm the process at the end NOTE The tap is registered when you remove your finger from the screen so dont 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 Focus Hold the top of the monitor and the bottom of the monitor and push backward or forward for easy adjustment 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 M Adjusting the System 40 Chapter 3 February 2014 Flex Focus 1202 User Guide BB1756 M Chapter 4 Battery Support This chapter is only relevant if your system has battery support The battery pack enables you to operate the system while it is not connected to an external electrical supply Before You Start Plug imaging system into wall before inserting batteries Be sur
13. 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 protocol see the DICOM chapter in Flex Focus 1202 Advanced User Guide BB1949 T Caution 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 Caution A safe encrypted protocol for data transmission approved by the hospital must be used This is to prevent unauthorized people from getting access to the data 22 Chapter 2 February 2014 Flex Focus 1202 User Guide BB1756 M Medical Equipment WARNING ME 1 Power Follow the guidelines in EN 60601 1 1 7 Safety requirements for medical electrical source systems Equipment that complies with the requirements of EN IEC 60601 1 2 Part 1 General requirements for safety UL 60601 1 4 or CSA C22 2 No 601 1 M90 5 can be connected to the system but one of the following conditions must be fulfilled e Each piece of equipment is plugged directly into an independent wall power outlet or e 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 WARNING ME 2 Printers an
14. 1756 M Battery When a battery reaches the end of its lifespan the replace battery message appears lifespan on the monitor at start up informing you which of the 4 batteries must be replaced Note that the batteries are referred to by number in the message with 1 being the top battery and 4 being the bottom battery Replace When it is time to replace a battery a message appears on the monitor telling you battery which batteries should be replaced The battery numbers in the message refer to the message numbering used in Fig 4 4 One or more batteries are wearing out Consider replacing the following batteries 2 3 where 1 is the top battery Figure 4 8 Message when a battery reaches the end of its lifespan Battery On average a battery will need to be replaced after approximately 300 recharge and lifespan discharge cycles the battery lifespan For information about the disposal of depleted batteries see page 24 Battery Support Setup To customize the 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 14 Cleaning and Disinfection The cleaning and disinfection instructions for the system in Care Cleaning amp Safety apply to the battery pack Battery Charger Station U
15. 6 M Remote Control 51 52 Chapter 5 February 2014 Flex Focus 1202 User Guide BB1756 M Chapter 6 Getting Started Getting Started with Flex Focus forms part of this user guide Flex Focus 1202 User Guide BB1756 M Getting Started 53 54 Chapter 6 February 2014 Flex Focus 1202 User Guide BB1756 M Chapter 7 Specifications and Indications for Use Specifications for the system are included in the Product Data sheet for the system which forms part of this user guide See Table 1 1 on page 5 Indications for Use The system is intended for use by qualified physicians for ultrasound evaluation Specific clinical applications and exam types include e Abdominal e Cardiac not for direct use on the heart e Fetal e Intraoperative e Intraoperative Neurological e Musculoskeletal Conventional e Musculoskeletal Superficial e Neonatal Cephalic e Obstetrics e Pediatric e Peripheral Vascular e Small Organ e Transrectal e Transurethral e 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 1 Neonatal cephalic imaging on the Flex Focus 1202 has not been CE approved or licensed by Health Canada Flex Focus 1202 User Guide
16. A1247 Powering the battery charger station Charge time Flex Focus 1202 User Guide BB1756 M NOTE This section is only relevant if you have purchased the optional battery charger station UA1247 See the Flex Focus Product Data sheet for ordering information The battery charger station is a stand alone device with the sole purpose of recharging batteries used by the system battery support that uses UA1225 batteries The battery charger station is powered when plugged into the power outlet There is no power switch on the battery charger station for turning it on or off It takes approximately 2 hours and 45 minutes hours to recharge 4 batteries in the station Battery Support 47 Battery indicators The display on the back of the battery charger station shows of battery capacity see Fig 4 2 A display of indicates there are no batteries in the battery charger station When the door to the battery charger station is open you can see LED indicator lights showing the status of each individual battery see Fig 4 4 LED Indicator Light Battery Status Green light Charged Red light Battery level is below 33 Off No battery in slot or battery is flat Recharging a Battery in the Battery Charger Station To insert or remove batteries 1 Press 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 ch
17. NING EMC 1 Do not use this equipment adjacent to other equipment If you must place it next to or stacked with other equipment verify that it operates normally there and neither causes nor is affected by electromagnetic interference February 2014 Flex Focus 1202 User Guide BB1756 M EMC noise can reduce the usable image depth Therefore to avoid having to repeat an ultrasound examination you must make sure beforehand that the ultrasound system can be used for the examination Repeating an examination can be regarded as a potential risk that should be avoided especially if the examination involves transducers used intracorporeally or transducers used for puncture RF Radio Frequency Interference Portable and mobile RF radio frequency communication equipment can affect the system but the system will remain safe and meet essential performance requirements An ultrasound system intentionally receives RF electromagnetic energy for the purpose of its operation The transducers are very sensitive to frequencies within their signal frequency range 0 3 MHz 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 Caution Other equipment may interfere with the system even if that other equipment complies with CISPR International Special Committee on Rad
18. Push all batteries into place and close the battery pack door This procedure resets the safety feature and should resolve the issue If the problem persists for example the fan does not start contact your BK Medical 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 necessary on the image area of the touch screen because it is not touch sensitive AN WARNING TS 1 Touch screen To avoid misdiagnosis of an image make sure the touch screen is clean before use must be clean Remote Control If you use a wireless remote control UA1237 with the system be sure to read the remote control chapter of this user guide The remote control uses short wave radio waves to communicate with the system WARNING RC 1 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 Caution The remote control can be disrupted by other equipment operating at the same frequency of 2 5 GHz Flex Focus 1202 User Guide BB1756 M Safety Information 25 This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 This device must accept any interference received
19. T TESTING TO DETERMINE THAT THE SOFTWARE IS SUITABLE FOR USE s 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 and other governments For additional information on exporting Windows XP Embedded see http www imicrosoft com exporting e The Flex Focus 1202 Ultrasound System is closed Any modification of or installation of software to the system may compromise safety and function of the system 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 Trademarks DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information FireWire is a trademark of Apple Computer Inc HistoScanning is a trademark of Advanced Medical Diagnostics SA Microsoft and Windows are registered trademarks of Microsoft Corporation in the United States and other countries 2014 BK Medical Information in this document may be subject to change with
20. al If the original power cords are missing or damaged you must order new ones from powercords vour local BK Medical representative Additional Protective Ground and Potential Equalization t Anadditional protective ground can be connected to the L terminal underneath the control panel see Fig 2 1 The potential equalization terminal underneath the control panel is connected to the system chassis It can be connected to corresponding terminals on other equipment to eliminate potential differences Do NOT use it for additional protective grounding auu N eg JE Figure 2 1 The terminals for potential equalization and additional protective ground A 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 WARNING C 1 Connection Follow the guidelines in EN60601 1 1 7 Safety requirements for medical electrical systems guidelines when you connect the system to other equipment Network Connection BK Medical s range of ultrasound systems comply with the DICOM standard for handling storing printing and transmitting information in medical imaging DICOM includes a file format definition and a network communication protocol which facilitates the exchange of data between electronic medical systems For detailed information about e network requirements e network configuration e workflow between devices e t
21. arged 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 24 NOTE See the warning about using only authorized UA1225 batteries BS 2 in Battery Support System on page 24 Cleaning and Disinfection 48 Chapter 4 The cleaning and disinfection instructions for the system in Care Cleaning amp Safety apply to the battery charger station February 2014 Flex Focus 1202 User Guide BB1756 M Chapter 5 Remote Control A wireless remote control is available for use with some versions of the Flex Focus system It uses short wave radio waves to communicate with the system and control many of its functions The Remote Control and Its Functions S7 Blue diode Blinks to show Battery level Blinks to warn that R e remote control is awake batteries must be replaced soon Change exam type list Capture an image to the willappear on monitor EXAM cy system hard disk or print it User definable Select e Start Stop imaging Adjust value or size of zoom box etc Holding down the key repeats the action E ais a oo 2 T Adjust gain for one mode only PRET Coloris aos aP er Q B the first in this list that is active Doppler adjust Color PRF a a Doppler Color Power B mode Toggle imaging modes Start a default measurement X X B gt C gt D B gt Color gt Doppler gt B User definable User definab
22. asurements This inaccuracy may be further increased by refraction occurring at tissue boundaries e The user can introduce errors when using approximate formulas when positioning the system s calipers with respect to the ultrasound image and when outlining structures in the image e The ellipsoid volume approximation described in this user guide is only applicable when the cross section of the structure being studied approximates an ellipse the circle being a special ellipse and when the structure is roughly symmetrical about the selected axis of rotation NOTE The choice of the axis of rotation is important for the calculation of the volume A vertical axis gives a different volume than a horizontal axis The minimum requirement is that the cross section outlined by the user should be convex If the user draws a non convex outline an inaccuracy is introduced which is not taken into account in this section In this case the system calculates and displays the convex hull of the figure that is the smallest convex figure containing the non convex figure outlined by the user see Fig 2 7 The system bases the calculation of the ellipsoid volume on the convex hull 912927 Figure 2 7 The dotted line indicates the convex hull of the non convex figure Measuring volume using a stepping method produces an approximation caused by the finite number of steps in the measurement The user must always try to assess how large an inaccurac
23. ation including Warning BS 5 below is printed on one side of the battery UA1225 WARNING BS 5 Charge only with a SMBUS complaint level 2 or 3 charger Do not heat above 80 C Do not open battery dispose of in fire or short circuit may ignite explode leak or get hot causing personal injury Replace battery with same part number only Use of another battery may present a risk of fire or explosion Keep away from children lt 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 To re purchase contact your local BK Medical representative Can be found on www bkmed com February 2014 Flex Focus 1202 User Guide BB1756 M If the System Will Not Start The batteries supplied for use with the system are called smart batteries which means they have built in safety features to prevent overloading If for unknown reasons the batteries are overloaded and the safety feature is triggered you may not be able to start the system even if it is plugged in to a power source To reset the batteries 1 Unplug the system 2 Open the door on the battery pack 3 Pull out all 4 batteries approximately 1 cm so they are no longer connected inside the battery pack Wait approximately 1 minute Plug in the system Make sure that the fan is started N oO ue A
24. ative Flex Focus 1202 User Guide BB1756 M Safety Information 23 Battery Support System 24 Chapter 2 Battery disposal AN If you use a battery pack to supply power to the system be sure to read the battery support chapter of this user guide Also observe the following warnings for both the battery pack and the optional battery charger station UA1247 WARNING BS 1 To ensure proper ventilation and avoid overheating keep both ends of the battery pack or optional battery charger station UA1247 clear WARNING BS 2 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 3 The batteries in the battery pack or optional battery charger station UA1247 may present a risk of fire or chemical burn if mistreated Do not disassemble heat above the manufacturer s maximum temperature limit or incinerate Replace battery with the UA1225 battery set only Use of another battery may present a risk of fire or explosion When you dispose of the batteries you must follow national rules Within the EU you must send them to appropriate facilities for recovery and recycling WARNING BS 4 Dispose of used batteries properly Keep away from children Do not disassemble and do not dispose of in fire Information Printed on the Battery UA1225 The following inform
25. caution or warning symbol 7 Cautions about 7 20 CE marks 9 center frequency 32 connectors for other equipment accessing 15 location 15 47 picture 16 table 17 consult instructions for use symbol 7 Creutzfeldt Jakob warning 27 D DICOM conformance statement 15 connection if network is not isolated 20 network isolator 20 standard 14 disposing of the system 8 distorted image 12 Doppler measurements accuracies 37 warnings 28 Doppler mode fetal imaging 34 dust protection 9 E earth See ground electrical noise 12 electrical safety 13 electrical shock 11 electromagnetic compatibility See EMC electromagnetic interference 12 EMC attaching cables 19 data in BZ2100 5 noise checking for 13 precautions 12 equipment failure 9 ESD precautions 12 symbol 8 12 training 12 examination performing basic See Getting Started examination viewing See Getting Started explosion hazards 11 exposure level 31 57 extension cord do not use 13 F fetal imaging acoustic output settings for 34 fuses replacing 16 replacing battery pack 42 G ground earth additional protective adding 14 symbol 8 H height adjusting See Getting Started HF electrosurgical equipment warning 26 HistoScanning connector for 18 19 l image distortion 9 12 indications for use 55 installation 13 Internally Powered battery pack 8 isolation from line voltage 10 K keys basic overview See Getting Started
26. cking whether the automatic measurements are reasonable Curves drawn on very noisy spectra may lead to misplacement of measurement cursors Make sure that measurement cursors are positioned so that the results are reasonable If they are not you must adjust the position of the cursors manually Nuchal Translucency Caution You must be adequately trained before you attempt to make nuchal translucency measurements VFI Vector Flow Imaging AN Artifacts AN Arrow aliasing AN Diameter markers 28 Chapter 2 WARNING VFI 1 Before you turn on VFI check the B mode image to make sure there are no artifacts visible in the blood vessel If there are strong artifacts in the B mode image the arrows in VFI may be pulled to point in a more axial direction toward or away from the transducer especially in low flow situations with correspondingly low PRF These artifacts will not affect the color mode CFM image so it is important to check in B mode WARNING VFI 2 Check to make sure the VFI arrows are not aliasing before you activate the assisted Doppler gate placement Otherwise the Doppler gate will not be positioned correctly WARNING VFI 3 Check to make sure that the diameter markers correspond to the inner vessel wall and that the connecting line between the markers is perpendicular to the direction of the vessel Otherwise the real time volume flow measurement may not be precise February 2014 Flex Focus 1202 User G
27. d An approved printer specified in the Product Data sheet can be connected to the internal auxiliary auxiliary power outlet on the system Do not use the auxiliary power outlet on the Flex Focus power outlet 1202 for any other equipment The auxiliary power outlet is still live even when the ON Standby button on the system is ON Standby turned off To remove voltage from this outlet you must unplug the power supply cord button does from the power source not turn off outlet Non Medical Equipment E WARNING NME 1 Follow the guidelines in EN 60601 1 1 7 Safety requirements for medical electrical systems If you connect non medical equipment instruments that do not comply with safety requirements for medical equipment such as a video monitor video recorder endoscopic camera control unit or other documentation device this equipment must be placed outside the patient environment 1 5m from the bed for example The equipment must fulfill the relevant EN standard or other applicable national or international standard One of the following conditions must be fulfilled e The system and other equipment are plugged into an external common isolation transformer to control the leakage current during a ground connection fault or e The system is grounded with an additional safety ground connection see Additional Protective Ground and Potential Equalization on page 14 If in doubt contact your local BK Medical represent
28. e FDA or licensed by Health Canada 18 Chapter 2 February 2014 Flex Focus 1202 User Guide BB1756 M 9 Pull firmly to open i so you can attach F Wa the connecting cable H BI A cable AO1385 is supplied to use with this connector Figure 2 4 Connector for HistoScanning Using the System with a Lithotriptor Special considerations apply if you are using a lithotriptor with the system e The lithotriptor must comply with the guidelines in EN 60601 I 1 7 Safety requirements for medical electrical systems e You must have a license installed to use a lithotriptor with the system e You must always follow instructions in the manufacturer s user guide for the lithotriptor A WARNING LT 1 To avoid an inaccurate location of the crosshair cursor due to misalignment of recorded image and graphics ensure the coordinate systems are synchronized Power Connections Do NOT connect a lithotriptor to the auxiliary power outlet Plug the system and the lithotriptor directly into independent wall power outlets Connecting the System to the Lithotriptor Connect the lithotriptor to a USB connector on the system If necessary use a USB RS 232 adapter cable Follow the connection instructions in the manufacturer s user guide for the lithotriptor system The connections must follow the guidelines given in EN 60601 1 1 7 Safety requirements for m
29. e to read the battery support warnings warnings with BS numbers in Battery Support System on page 24 Also note the following NOTE To ensure that batteries charge properly you MUST connect the power supply cord to the line voltage BEFORE you insert any batteries in the battery pack Be sure to read the rest of this chapter before you use the battery support system To configure and customize the 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 Turn on the system 3 When the batteries run down you do not have to turn off the imaging system Either e plug it into the wall to recharge the batteries while you run on power from the normal power supply or e plug it into the wall change the batteries see Changing or Replacing a Battery on page 46 unplug from the wall and run on battery power again If you have an extra set of batteries that you charge with a battery charger station 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 M Battery Support 41 Battery pack
30. eania ate Lait ete aun wet Rd E RR Goes at 19 Isolation of DICOM Network 2 20 0 060s 20 Wireless Network WIFI 20 Medical Equipment ccAlii 8 0254 Ge araduS Sear das tetdeeee sik ks 23 Non Medical Equipment 5 rrene 23 Battery Support System e erroreren 24 If the System Will Not Sant 25 TouchScreen muren e ea a I r E a E Nat E ANa 25 Remote Control n n 2 ositiaaeete ots See raae eienees Saas 25 Computer SECU eange n ZEA a a A EEE RA h dane 26 Servicean d GDS x cs rarere TH T R RRR E Ra Nd e meus 26 Transducers TTT 26 During an PNamMinanOns 2 24 4 siys oop teat ei 5 a5 eek eee aeen eens 27 Checking the Date 21 Verifying the Transducer Type 21 IMBaSUREMICNIS s se aatedeautuibe AR 0 E K EEEE EEE tha 28 VFI Vector Flow Imaging se enisacnisuase ssetactens Vienne 28 Puncture and Brachytherapy dis haves ead essen die eee nukes 29 D ee ree Ge ETA EEE T E EET 30 Pic tike dn Picture 0 0 T E AAT RCE E EA RRR ee EEEN 31 Acoustic Output tek Se Oy eis ee BUN Ga gees iy mame AEG A Ee 31 RTC a sista kad has tle is a ge seh See es epee E aihs aa ined ae ged 31 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Monitor Displays iat catered ish pioeeeeedowed seas aneaeouews 32 Thermal and Mechanical Indices 32 Acoustic Output Measurements 4 2 05 5 nstei eee oeeases aoe Sey ces 33 Functions Affecting Acoustic Output 0 cece ee eee eee 33 Default Acoustic Output 0 cee eens 34 Clinical
31. echnical specifications e safety specifications 14 Chapter 2 February 2014 Flex Focus 1202 User Guide BB1756 M see BK Medical s DICOM conformance statement at http www bkmed com DICOM_en htm Network Security It is the responsibility of the on site personnel or technician to maintain the IT network and identify analyze evaluate and control new risks caused by 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 e Corrupt patient data due to network errors see Warning Exam 3 on page 27 e System is unable to use the network due to faulty or overloaded network see Warning GS 1 on page 9 e System overloads the network causing other equipment to fail Network NOTE 7f your system interacts with other equipment directly or indirectly you must guidelines ensure that your network is properly dimensioned and that critical equipment is placed ona separate network Otherwise you could risk overloading the network and your equipment failing Network Printing For printing on network printers BK Medical supports protocols PCL 5 PCL 6 and PS Post Script 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 To access them unscrew the screw on the bottom of the neck and remove the connector cover See
32. eck of the Flex Focus system 16 Chapter 2 February 2014 Flex Focus 1202 User Guide BB1756 M Symbol Connector Additional Information DVI I DVI I Connector for auxiliary DVI or VGA monitor KAIK 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 gt Cop Composite S video Out 7 pin S video connector see Table 2 3 for pin layout that can be adapted to a composite video output see Table 2 4 Audio In Audio Out Bis 4 USB 2 0 connectors A type 500mA current limit on each C FireWire Not currently supported For future use gee 10 100 1000 Ethernet LAN 10 100 1000 LAN connector RJ45 Table 2 2 Connectors in the neck of the Flex Focus system S Video Pin Name Description connector pin layout 1 Y GND Luminance Ground 4 pe 3 2 CGND Chrominance Ground AXK 3 Y Luminance 00 6 ieee 4 C Chrominance CVBS Composite Video CVBS GND Composite Video Ground 7 pin S video MINI DIN Female a NC EE Table 2 3 S video connector pin layout Video Output Although 4 different video output signal formats are available the image quality is not the same for all of them Dvigivesbest To get the best image quality possible connect your monitor or other video image quality equipment using the output signal that gives the highest quality image See the list below Output signal types in order of
33. ed assuming a tissue attenuation of 0 3 dB cm MHz when the estimated in situ derated value I is described by the following equation formula I I exp 0 069 fz where the variables are defined in the table below Variable Definition lw Intensity in water at the position where is maximum f transducer frequency in MHz Z distance in cm from the transducer face to the position where I is maximum It should be stressed that the in situ values given are only applicable when there is attenuating tissue between the transducer face and the focal point Possibility of Adverse Effects Although it is believed that diagnostic ultrasound causes no significant biological effects in mammalian tissue 3 10 the user should be aware of the hypothetical possibilities of adverse effects 11 13 14 Fetalimaging Current scientific and clinical concern over possible adverse effects is particularly focused on fetal ultrasound imaging It is due to the increased sensitivity of mammalian cells and organs at this phase of their development and the fact that such a risk could have profound implications on public health 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 Functions Affecting Acoustic Output The system has a control function that ensures that neither the Ispra nor MI
34. edical electrical systems EMC Requirements To fulfill EMC requirements cables attached to the system must be shielded and no longer than 5 m Flex Focus 1202 User Guide BB1756 M Safety Information 19 1 Wi Fi on flex Focus 1202 systems has not been licensed by Health Canada 20 Chapter 2 Connector name Cable type Type and length DVI I Dual link Shielded 5m S video composite In S video Shielded 5 m S video composite Out S video Shielded 5 m Audio In Stereo 3 5 mm jack Shielded 5 m Audio Out Stereo 3 5 mm jack Shielded 5 m USB 1 USB 2 0 Shielded 5 m USB 2 USB 2 0 Shielded 5 m USB 3 USB 2 0 Shielded 5 m USB 4 USB 2 0 Shielded 5 m FW400 FireWire Shielded 5 m 10 100 1000 Ethernet Network CAT6E Shielded 5 m HistoScanning Research MDR 26 Shielded 3m Interface Table 2 5 List of cables used in testing for EMC compliance Do not attach transducers and other accessories unless the user guide for the transducer or accessory states that it can be used with this system Attaching other equipment may cause an increase in electromagnetic emissions or may cause the system to be more sensitive to electromagnetic interference Isolation of DICOM Network The system must not be galvanically 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 DP 0925 Wireless Network Wi Fi The syste
35. er unit used to turn system on and off S Not watertight Plug may not be immersed unless it is covered with a special watertight plug cover s ESD electrostatic Do not touch pins in connectors with this symbol Ata discharge unless you follow ESD precautionary procedures Specified Radio On remote control UA1237 This equipment Gr 204WW111003 Equipment conforms to Japanese Radio Law regulations concerning frequency and power IZ WEEE Waste Within the EU when you discard the equipment you must send it to appropriate facilities for recovery and recycling mm Battery Waste On battery UA1225 Dispose of used batteries properly When you dispose of the batteries you must follow national rules Within the EU you must send LHON them to appropriate facilities for recovery and recycling China ROHS 25 Years Environmentally Friendly Use Period for ROHS is 25 Lifetime years es Battery recycle On battery UA1225 Recycle used batteries properly Internally Powered ily powered or internal 100V 60HzZ 100V 230V SOHZ 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 power source Table 2 1 Symbols and information on the equipment continued 8 Chapter 2 February 2014 Flex Focus 1202 User Guide BB1756 M CE Marks on Electrical Devices The European Union has introduced directives requiri
36. erify that it corresponds with the chosen matrix Then check the matrix alignment See Care Cleaning amp Safety for instructions Pay particular care to the following safety issues when operating the 3D system WARNING 3D 1 Measurements obtained with the 3D system and used in diagnosis must be carefully and thoughtfully performed to ensure accurate 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 Medical service representative to check and confirm the system s proper operation WARNING 3D 2 You cannot make accurate measurements on a 3D data set acquired using the untracked freehand method If you start to make a measurement on a 3D data set acquired using the untracked freehand method the following warning appears on the monitor Symbol Description Nx x Measurement will not be accurate February 2014 Flex Focus 1202 User Guide BB1756 M Picture in Picture Ax WARNING PIP 1 PiP must not When you use Picture in Picture do not cover critical information such as TI or MI on the cover monitor Make sure that all important information will appear if you print or save the important ultrasound image information Acoustic Output General Medical research has yet to prove whether or not ultrasound causes biol
37. ge is an indication of the expected needle path The needle tip echo should be monitored at all times so any deviation from the desired path can be corrected NOTE f the image depth is set very low to see tissue close to the transducer with high magnification the needle tip echo can be outside the displayed image area To see the needle tip in this case zoom out so the full needle path is visible or pan the image to the side to keep the high magnification WARNING P 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 Safety Information 29 AN Verify matrix type and coordinates AN Verify user defined matrix A Verify matrix alignment 3D A 3D measure ments A Untracked freehand Warning on monitor 30 Chapter 2 Brachytherapy and Prostate Transperineal Biopsy WARNING B 1 Verify that the matrix type and coordinates displayed on the monitor agree with the actual matrix template you are using WARNING B 2 If you create a user defined matrix it is your responsibility to verify that the matrix that appears on the monitor corresponds to the physical matrix you are using WARNING B 3 Before you use the matrix for seed implantation or biopsy check the matrix offset value to v
38. h part must be securely mounted to a stable support so that it does not tip fall or come loose and injure someone WARNING MS 3 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 February 2014 Flex Focus 1202 User Guide BB1756 M AN Don t push too hard WARNING MS 4 To avoid injury and equipment damage do not push the system too hard especially when you roll the system over an uneven surface Applying excessive force near the top could cause the system to overbalance and tilt Explosion Hazards AN Explosion hazards WARNING EH 1 The equipmentis not designed to be used in potentially explosive environments It should not be operated in the presence of flammable liquids or gases or in oxygen enriched atmospheres There is a possible explosion hazard if the equipment is used in the presence of flammable anesthetic 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 Medical service representative Electrical Safety AN Do not use a power strip A Leakage current A Electrical shock WARNING ES 1 Do not plug the equipment into an ordinary power strip If the ground connection fails this is dangerous because e the
39. io Interference emission Possible requirements interference sources Caution If you use accessories transducers or cables with the system other than those specified increased emission or decreased immunity of the system may result Use specified equipment only Installation WARNING 1 Installation To ensure safe performance a qualified electrician or hospital safety personnel must verify safety that the equipment is correctly installed and that it complies with the following safety requirement requirements e 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 change the plug on the power supply cord e Allequipment must only be connected to a grounded AC power supply or wall outlet that meets EN IEC NEC requirements or applicable local regulations The examination room s grounding system should be checked regularly by a qualified electrician or hospital safety personnel e Never use extension cords The increased length of the cord will increase the resistance of the protective ground conductor and may increase the equipment s leakage current beyond an acceptable level e Keep power cords sockets and plugs clean and dry at all times e Make sure that the power supply cord cannot be accidentally disconnected from the power source or the equipment Flex Focus 1202 User Guide BB1756 M Safety Information 13 Origin
40. ipment Part 1 1 General requirements for safety Collateral standard Safety requirements for medical electrical systems 8 Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Sys tems and Transducers FDA Center for Devices and Radiological Health September 2008 9 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment AIUM NEMA 2004 10 Standard for Real Time Display of Thermal and Mechanical 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 Medical 1993 13 Bioeffects considerations for the safety of diagnostic ultrasound Journal of Ultrasound in Medicine Vol 7 No 9 supplement September 1988 Flex Focus 1202 User Guide BB1756 M Safety Information 37 14 The safety of diagnostic ultrasound The British Institute of Radiology 1987 AIUM American Institute of Ultrasound in Medicine 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 38 Chapter 2 February 2014 Flex Focus 1202 User Guide BB1756 M Chapter 3 Adjusting the System Calibrating the Touch Screen Alignment If you have
41. is user guide The uncertainty level for each parameter is also listed For definitions of the parameters refer to the Food and Drug Flex Focus 1202 User Guide BB1756 M Safety Information 31 32 Chapter 2 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 Track 3 acoustic output will not be evaluated on an application specific basis but the maximum derated Spatial Peak Temporal Average Intensity Ispra must be lt 720mW cm the maximum Mechanical Index MI must be lt 1 9 and the maximum Thermal Index TI must be lt 6 All BK Medical 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 Thermal and Mechanical Indices The MI and TI indices are intended to allow users to implement the ALARA 11 12 As 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 3 and AIUM NEMA standard 10 but the formulas are given below MI Formula MI P 03 Zsp where the variables are defined in the
42. l D User Guide bk medical Type 1202 Flex Focus Ultrasound Systems English C 0543 BB1756 M February 2014 For Professional Users Only LEGAL MANUFACTURER BK MEDICAL Mileparken 34 2730 Herlev Denmark Tel 45 4452 8100 Fax 45 4452 8199 www bkmed com Email info bkmed dk The serial number of a BK Medical product contains information about the year of manufacture To obtain the date of manufacture of a product please contact your BK Medical representative or write to us at the email address above including the product s serial number SN number BK Medical Customer Satisfaction Input from our customers helps us improve our products and services As part of our customer satisfaction program we contact a sample of our customers a few months after they receive their orders If you receive an email message from us asking for your feedback we hope you will be willing to answer some questions about your experience buying and using our products Your opinions are important to us You are of course always welcome to contact us via your BK Medical representative or by contacting us directly If you have comments about the user documentation please write to us at the email address above We would like to hear from you Scanner Software e NOT FAULT TOLERANT THE SOFTWARE IS NOT FAULT TOLERANT BK Medical HAS INDEPENDENTLY DETERMINED HOW TO USE THE SOFTWARE IN THE DEVICE AND MS HAS RELIED UPON BK Medical TO CONDUCT SUFFICIEN
43. le User defined a AUTO Optimize image and Doppler settings L pa d Hold down P and AUTO for three seconds when pairing with the system zt BK Medical Figure 5 1 The remote control with the location of its various controls Pairing the Remote Control with the System 1 Plug the Mini Bluetooth Adapter into a USB connector on the system Use the adapter that came with the remote control Press any key on the remote control to wake it up 3 Hold down the P and AUTO keys on the remote control for three seconds The remote control emits two beeps 4 Release the keys after the second beep Flex Focus 1202 User Guide BB1756 M Remote Control 49 The blue diode starts blinking fast A dialog box appears on the monitor This may take up to two minutes 5 Click Accept to pair the system with the remote control indicated by its serial no The pairing process takes up to one minute When pairing is done the remote control emits a beep and the blue diode blinks to show the remote control is awake NOTE The pairing process may time out Try again if this happens NOTE f the cursor starts drifting on the monitor place the remote control in its holder and leave it for 30 seconds to recalibrate If you have more than one remote control be sure you know which system each is paired with the system and remote control remain paired even if the remote control is taken away to be disinfected Pairing lasts until you pair the rem
44. liasing occurs corresponding 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 A 13 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 performance 3 EN 60601 2 37 2001 A1 2005 A2 2005 Medical electrical equipment Part 2 37 Par ticular requirements for the safety of ultrasonic medical diagnostic and monitoring equip ment EN 60601 2 37 2008 Medical electrical equipment Part 2 37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and moni toring equipment 4 UL 60601 1 2003 Medical Electrical Equipment Part 1 General Requirements for Safety 5 CSA C22 2 No 601 1 M90 Medical Electrical Equipment Part 1 General Requirements for safety 6 EN 60601 1 2 2001 A1 2006 Medical electrical equipment Part 1 2 General require ments for safety 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 7 EN 60601 1 1 2001 Medical electrical equ
45. m 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 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 16 Caution Do not use a USB extension cable to connect a Wi Fi adapter to the system If you do the wireless network may become unstable due to electromagnetic interference For information on how to install a license on the system see Appendix C in the Flex Focus 1202 Advanced User Guide BB1946 February 2014 Flex Focus 1202 User Guide BB1756 M Connecting to a Wireless Network You must establish a secure wireless network at your hospital clinic or institution including a password for the network before you can use the system 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 Advanced Capture Image Measure and Mark Documentation 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 ip BK Guest_N T HP85E440 U w ALOGWIFILAN Figure 2 6 Wi Fi connection window You only have to type in a password the first time you connect to a
46. ment please make yourself familiar with the information in the accompanying user information documents Some documents are printed and you will find the remaining documents on the accompanying User Documentation CD BB1984 Make sure that you also read the transducer user guide and specifications for each transducer that you use Document Information System User Guide Introductory information safety information getting started Getting Started User interface basic operating instructions Note this book is part of the system user guide System Advanced User Guide Information about advanced functions glossary Product Data for system Specifications for the system including disinfection methods that can be used Indications for use for each transducer that can be used with the system Technical Data BZ2100 Acoustic output data clinical measurements ranges and accuracies factory default power levels and data about EMC electromagnetic compatibility for all transducers Pro Package calculation formulas Care Cleaning and Safety Cleaning disinfection sterilization checking storing and disposing of BK Medical equipment Includes environmental limits Transducer User Guide Specific instructions for the transducer and puncture attachments Product Data foreach transducer Specifications for the transducer including disinfection methods that can be used Table 1 1 User information documentation that accompanies
47. ng C marks on devices Non medical devices marked with C comply with relevant directives for example EEC Directive 2004 108 EC concerning Electromagnetic Compatibility BK Medical devices marked with CE or C comply with EEC Council Directive 93 42 EEC of 14 June 1993 concerning Medical Devices C applies to Class I medical devices C applies to Classes Im IIa IIb and III BK Medical defines classes assuming imaging duration for individual patients does not exceed 60 minutes General Safety Precautions The ultrasound system is designed and tested in accordance with EN IEC 60601 1 2 Part 1 General requirements for safety and EN 60601 2 37 3 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment The ultrasound system and the optional battery charger station UA1247 comply with requirements for Class 1 protective earth and for systems that include 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 Caution Federal law in North America restricts this device to sale to or on the order of a 7 physician Physicians only vA WARNING GS 1 Proper Before you attempt to use BK Medical equipment you should be trained in Training ultrasonography or be unde
48. nor TI 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 M Safety Information 33 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 e Sizing functions such as ROI region of interest in general smaller size results in higher acoustic intensity because the pulse repetition frequency PRF is higher or the ultrasound beam is more strongly focused e Focus in general strongly focusing the beam makes the acoustic intensity higher e Frame rate higher frame rate results in higher acoustic intensity e Range increasing the Doppler range increases the acoustic intensity by increasing the PRF e CFM Resolution higher resolution increases the acoustic output e Color box size narrowing the color box generally increases the acoustic output within it The user can set a Thermal Index limit This will provide an upper limit for acoustic output Default Acoustic Output After the system has been turned off the transducers will start in the default setup when the system is turned on again The default setup may be factory defined or defined by the user The factory defined default setup values of acoustic output for each tra
49. nsducer are listed in the Technical Data BZ2100 These setups have been optimized to give the best compromise between low acoustic output and enough power to obtain the image features as quickly as possible This is part of the ALARA principle The factory default setup for all transducers is B Mode to ensure the lowest acoustic output when you start imaging When you enter a new patient ID by default the transducer setup will be reset to the factory setup Fetal imaging When you use transducers intended for fetal imaging it is important to make sure that the default settings are appropriate and to reset to the default setting before imaging a new patient 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 34 Chapter 2 February 2014 Flex Focus 1202 User Guide BB1756 M The measurement accuracies are based on the assumption of ideal tissue that is a tissue characterized by a sound velocity of 1540 m s When making clinical measurements with ultrasound errors may arise which are not taken into account in this section For example e 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 me
50. ny way Symbol Name Description Caution or Warning Consult accompanying user guides when you encounter this sign on the instrument to avoid reducing its safety BA Consult instructions Consult user guide or other instructions for use 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 wd Manufacturer Legal manufacturer ye UL Classification for UL requirements are met for special conditions 0 Canada and US Table 2 1 Symbols and information on the equipment Flex Focus 1202 User Guide BB1756 M Safety Information Symbol Name Description UL Recognized UL recognizes this as part of a UL approved apparatus cA US Component for Canada and US Potential Terminal connected to the chassis Should be Equalization connected to corresponding terminals on other equipment to eliminate potential differences al Ground earth Additional protective ground earth Type BF BF Isolated from ground S Maximum patient leakage current under e Normal condition lt 100uA Single fault condition lt 500 uA a Type BF BF defibrillator proof Type B B Maximum patient leakage current under e Normal condition lt 100uA Single fault condition lt 500uA ip Sealing Dust and immersion protected according to EN 60529 1 ly Standby Symbol on ON Standby button on back of scann
51. oard dock remove the batteries from the battery pack Do this before you try to make any repairs to the system Caution Do not spill liquids on the equipment Caution Large variations in temperature or humidity may cause water to condense inside the system If this happens the system may fail to operate properly Always let the system come to room temperature before you plug it in e Wait at least 2 hours after the system has been subjected to major changes in temperature or humidity e lf there is visible evidence of condensation wait at least 8 hours Before you use the equipment make sure that all the safety requirements described in this chapter have been satisfied Mechanical Safety AN Mechanical injury A All parts must be stable A Don t drop the scanner unit 10 Chapter 2 Mechanical failure or unintended use of ultrasound equipment can result in physical injury to patients or operators WARNING MS 1 Be careful to avoid the following potential sources of injury e Parts of the body can be pinched by moveable parts of the equipment such as the control panel e Tilting the system can cause it to be unstable and injure someone Do not lean or sit on the control panel or any other part of the system The control panel or monitor can break if subjected to heavy weights or impact WARNING MS 2 When parts of the equipment can be mounted individually for example for use in an operating room eac
52. ogical effects Therefore prudent use considerations require you to follow certain guidelines see EN60601 2 37 3 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment Prudent Use i WARNING AO 1 Exposure Always keep the exposure level the acoustic output level and the exposure time as low as level possible e Image patients only when clinical reasons make it necessary e Keep exposure time as short as possible e Be careful to prepare the patient correctly so that you get the best possible image e Start imaging at a low acoustic output level see Thermal and Mechanical Indices on page 32 and increase the level only as much as necessary to obtain a satisfactory image e Ifyou switch from an application requiring high acoustic output levels see Functions Affecting Acoustic Output on page 33 to one that requires lower levels fetal imaging for example be sure to reset the levels before you image For example start in B mode e 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 in bone rather than in soft tissue because the ribs will be subjected to ultrasound WARNING AO 2 Appropriate Always use the transducer best suited to the examination transducer Acoustic output data for transducers used with the system are given in the Technical Data BZ2100 that accompanies th
53. ote control with another system or pair another remote control with the system 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 monitor To move the cursor tilt the remote control that is move the front end up down or side to side The mouse will not respond if you keep it level NOTE You do not need to point it at the monitor The cursor responds to changes in the position of the remote control not to the position itself To select an object on the monitor move the remote control so that the cursor is on the object then press Select Replacing Batteries 50 Chapter 5 1 Remove the battery cap 2 Insert 2 batteries LR6 size AA 1 5 volt 3 Screw the battery cap on tight until the arrow points to the area aie 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 February 2014 Flex Focus 1202 User Guide BB1756 M Cleaning and Disinfection For details of cleaning and disinfecting the remote control see Care Cleaning amp Safety Flex Focus 1202 User Guide BB175
54. out notice Contents Chapter 1 Chapter 2 English source version BB1756 L General Information fi ss ss e s e x e x e cess e e e e x e x e venue e eean 5 Safety Information s ss s s s s s e s e e e s e s e s e s e apiece asain 7 Safety Information sos yoda es ecu E r eae SARTRE dae RAE E RR 7 Safety Symbols and Information on the Equipment 0005 1 CE Marks on Electrical Devices 9 General Safety Precautions eeu yas eee eee eae tao fe eee ed noe 9 Mechanical Safety 10 Explosion Hazards scv iuhit ce th weetiaey unas eh aA a we Gane saeeee Ne Oo 11 Electrical Safety a K N renere RHH ETLE RT A 11 ESD NKC TTT 12 Interference ha Gy Sod Se od E AR EES EE CR Oe es HE PAP 12 Electrical Noise M a EE RR A TRN N RN KRA AAEE RE a go 12 Electromagnetic Interferences 4 Sas oes ete ee nme ayaa sees 12 RF Radio Frequency Interference 2 26 gsadagues eosG a taneeareeee ead 13 Installations Se chika rs na AER T EE dem alias 13 Connecting Other Equipment tac ceiaavaselivereder sik e ce 4 14 Network Connection 0 44 d iccdeced eaeosu eure ee eis 6s Seaeiweee eo 250 14 Ne twork Securty A aR 09T EE err e Bib os Sent Pag ae T 15 Network Printing ei tee eto ieee bs Weems Settee eae i eee ns 15 COTO CLAUS R RER RR eae tne T alee Se Aah ates coed desl eis ered Oa T 15 FASO SCANNING Cia 9 2290 REEE KARTAR haters Cecelagoaetabarioas 18 Using the System with a Lithotriptor 0 0 00 19 EMC REQUIRE MCIIS 0 i oc
55. quality with digital DVI highest 1 DVI digital output that gives the best image quality 2 VGA this analog output from the DVI connector gives slightly poorer image quality than the digital DVI output Flex Focus 1202 User Guide BB1756 M Safety Information 17 3 S video analog output 4 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 4 shows you which adapters can be used Cable Connectors Adapter Flex Focus Connector in order of preference DVI D Not needed DVI I 15 pin VGA DVI to VGA adapter 2 views gt N DVI I Q e rA Re 4 pins S video b Not needed e oN BNC Composite 7 pin S video to Composite S BNC female to Phone male Eper I 4 Phono RCA Composite 7 pin S video to Composite E 7A 2 connectors 7 pin S video to S video and composite S video Composite eo same view on both I amp connectors Table 2 4 Video connectors and adapters HistoScanning The scanner units to be used with HistoScanning systems from AMD have an extra connector on the back of the monitor in the upper left corner It is used to take raw data before it has been converted to an image on the monitor out of the system To use the Flex Focus for HistoScanning you must have a HistoScanning license installed 1 HistoScanning has not been market cleared by th
56. r a new patient ID before you image a new patient Otherwise the documentation will not contain the correct patient identification and you will not be able to capture images and clips We recommend that you enter the complete name of the patient WARNING Exam 3 Verify that the patient name and ID are correct Verifying the Transducer Type A Type number displayed must match number on transducer Flex Focus 1202 User Guide BB1756 M WARNING Exam 4 Before you start to image verify that the type number on the transducer matches the number displayed on the monitor In case of any inconsistency stop imaging turn off the system and contact your local BK Medical representative Safety Information 27 Measurements AN Polygon measuring tool A Using Doppler curves A Nuchal translucency Pay careful attention when you position cursors to make measurements on a scanned image or on a Doppler curve WARNING M 1 When you use the polygon measuring tool if the sides of the polygon intersect 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 WARNING M 2 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 che
57. r the supervision of someone who is trained in ultrasonography You should also be thoroughly familiar with the safe operation of your ultrasound system read all the user documentation that accompanies it In addition if your system interacts with other equipment directly or indirectly you need to be trained in making sure the interactions are both safe and secure No further training is required but BK Medical offers training in how to use the system Consult your BK Medical representative for information T WARNING GS 2 Equipment If at any time the system malfunctions or the image is severely distorted or degraded or failure you Suspect in any way that the system is not functioning correctly e Remove all transducers from contact with the patient e Turn off the system Unplug the system from the power source and for systems that include the mobile battery keyboard dock remove the batteries from the battery pack to make sure it cannot be used until the system has been checked e Donottry to repair the system yourself e Contact your BK Medical representative or hospital technician Flex Focus 1202 User Guide BB1756 M Safety Information AN Isolating the system A Spilled liquids A Condensation WARNING GS 3 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 keyb
58. rted User Documentation CD 5 V VFI Vector Flow Imaging warnings about 28 viewing an examination See Getting Started virus checking external storage media 26 from network 26 W Warnings about 7 waste disposal symbol 8 WEEE waste symbol 8 Wi Fi adapter 20 connecting to 21 correct setup and safe protocol required cautions 22 network characteristics 22 password 21 signal strength 21 using 20 wireless network See Wi Fi 59 60 wd BK Medical ApS Mileparken 34 2730 Herlev Denmark Tel 45 44528100 Fax 45 44528199 Email info bkmed dk Innovative Solutions for Life Analogic Corporation creates innovative technology to improve the health and enhance the safety of people around the world We are committed to providing ultrasound solutions under the L H BK Medical brand name that advance medicine and save lives q nN q og O Analogic Corporation Headquarters USA BK Medical Sales and Service USA BK Medical Europe and Rest of World 8 Centennial Drive Peabody MA 01960 8 Centennial Drive Peabody MA 01960 Mileparken 34 2730 Herlev Denmark T 978 326 4000 T 978 326 1300 T 45 4452 8100 analogic com bkmed com F 45 4452 8199 bkmed com The name Analogic is a registered trademark of Analogic Corporation The globe logo is a trademark of Analogic Corporation
59. s This is true at all times May need to Ifthe Batteries Appear Not to Charge to 100 discharge and recharge After repeated use the batteries may require a full discharge full charge and full fully 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 battery status is visible both on the monitor in the bottom right hand corner and on the display on the back of the battery pack see Fig 4 2 e When the system is plugged into a power outlet battery status is shown as percent of capacity remaining e When the system is running on the battery battery status is shown as time remaining in hours minutes Information Available on the Monitor The battery status indicator appears in the bottom right hand corner of the monitor t a 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 24 Flex Focus 1202 User Guide BB1756 M Battery Support 43 Information Available on Battery Pack Battery pack display Battery indicators 44 Chapter 4 The display on the back of the battery pack shows of battery capacity or time left A display of indicates there are no batteries in the battery pack NOTE The
60. s 47 Recharging a Battery in the Battery Charger Station 48 Cleaning and Disinfection s usunn wares RAR eed oon ee 28 48 Remote Control iis dacedesetacievceteneddnatersa coer ener ener ENNAN 49 The Remote Control and Its Functions 0 0 00 ce cece ee eens 49 Pairing the Remote Control with the System n a nnnaauaaaeeeaa 49 DICED o aane aE EIEE a e ae een MRR AOS ORs aS 50 MOUSE RGDA ZRA PAs rE ERa ote T ad eS 50 Replacing Batteries ks ada cues oeb Viele eka cie de peace ees wantin 50 Cleaning and Disinfection s csy sl pase aaa est ene ese eed vene es 51 Getting Started isis WeNs iiss ensais tntan dya E E 53 Specifications and Indications for Use sss sss ss ss s ss s s s es s eean 55 TnGiCarlons TOE Use teg Za at S hoi de eA iets oak a d e a fl Sane 55 Contraindications ee 4 2 o dccaarecax axe a whe eee Gale ek oho a So LE eee 55 ERT EE a ene hg elite anaes Ratan bine Ea oa ae ates 57 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 Intended use The system is a 2D and 3D ultrasound echo and flow imaging system for diagnosis data processing and transfer and guidance of puncture and biopsy NOTE Some of the functionality and options described in this guide may not be available with your version of the system Before using the equip
61. surgical burns equipment BK Medical transducers fulfill EMC requirements when they are outside as well as inside the patient s body 26 Chapter 2 February 2014 Flex Focus 1202 User Guide BB1756 M AN Surface temperature on array AN Creutzfeldt Jakob disease WARNING T 4 Do not turn the transducer on and allow it to scan into mid air without ultrasound gel applied to the surface of the array Doing so may cause the surface temperature on the array to heat up to 27 C above room temperature measured according to EN 60601 2 37 3 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment To avoid this freeze the image when the transducer is not used for imaging WARNING C J 1 Do not use a transducer for neurosurgical applications if the patient is suspected of having 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 be destroyed following approved procedures for your hospital During an Examination Checking the Date AN Date AN Patient ID required A Verify patient ID Before you start imaging verify that the date and time displayed on the monitor are correct WARNING Exam 1 An incorrect date or time will make documentation of the image incorrect and may also cause some calculated values to be incorrect WARNING Exam 2 You must ente
62. table below Variable Definition P 0 3Zsp Peak Rarefactional Pressure MPa derated by 0 3dB cm MHz measured at Zp the point on the beam axis where pulse intensity integral Pll 3 is maximum fe measured center frequency in MHz TI Formula W TI 2 de where the vanables are defined in the table below Variable Definition W time averaged acoustic power of the source or other power parameter W Wag estimated power necessary to raise the temperature of the target tissue one degree Celsius W C February 2014 Flex Focus 1202 User Guide BB1756 M Blood As arule of thumb the Thermal Index TI indicates the highest expected perfusionand temperature increase in degrees Celsius It is based on an average level of blood perfusion The displayed TI may underestimate the temperature rise in poorly perfused tissues you must take this into account when deciding on the maximum TI you will allow Conversely in areas with a rich perfusion of blood the temperature increase will be less than the displayed TI indicates Fever A temperature increase of one degree Celsius increase in a patient with fever may cause complications in certain circumstances it may be safer to delay the investigation Acoustic 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 deriv
63. the equipment Improperuse Failure to follow safety instructions or use for purposes other than those described in the user manuals constitutes improper use Flex Focus 1202 User Guide BB1756 M General Information 6 Chapter 1 February 2014 Flex Focus 1202 User Guide BB1756 M Chapter 2 Safety Information The system can be used for continuous operation but imaging duration for individual patients must not exceed 60 minutes We recommend however that you turn off the system at the end of each workday Safety Information This user guide contains cautions warnings and other information about what you must do to ensure the safe and proper performance of the ultrasound system and the optional battery charger station UA1247 You must also follow local government rules and guidelines at all times I WARNING Warnings contain information that is important for avoiding personal injury Caution Cautions contain information and instructions that must be followed to avoid damaging equipment data or software NOTE Notes contain information that you should be aware of Safety Symbols and Information on the Equipment 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 a
64. the object you are interested in fills the region of interest as much as possible Distance and The accuracy of a distance measurement on a 3D image will never be better than 6 area accuracy the accuracy of an area measurement on a 3D image will never be better than 6 In the table in the Technical Data BZ2100 the overall measurement accuracy for a full range measurement is given in the right hand column for each measurement The footnote below the table states the digital image resolution Time Measurements In M mode and spectral Doppler mode data is displayed along a time axis It is possible to measure time differences The accuracy for a time difference measurement is e Rounded to the nearest 0 01 s e Accuracy 0 01 xt where r is the full time scale of the image field 36 Chapter 2 February 2014 Flex Focus 1202 User Guide BB1756 M Doppler Measurements In measuring blood flow velocity it is assumed that the measured power spectral distribution of the Doppler signal equals the blood cell velocity distribution The measurement accuracy of blood flow velocity is heavily dependent on the angle 0 between the ultrasound beam and the velocity vector of the blood cells The velocity accuracies given in the Technical Data BZ2100 are valid for 0 55 To find the percentage accuracy for other angles multiply the stated accuracy by cos cos 0 18 x 100 0 5 cos If the blood velocity exceeds the selected velocity range a
65. to verify transducer type number 29 pushing prohibited symbol 7 R radio frequency interference See RF interference remote control keys and indicators 49 mouse function 50 pairing 49 replacing batteries 50 sleep and waking up 50 RF interference 13 S safety electrical 11 13 transducer 26 saving to USB See Getting Started screen controls basic overview See Getting Started 58 sealing symbol 8 security network See network security service and repair 26 Specified Radio Equipment symbol Japan 8 standby symbol 8 standby button See Getting Started system isolation from line voltage 10 malfunction 9 T Technical Data BZ2100 5 31 34 36 Thermal Index limit setting 34 Thermal Index limit setting 34 TI Thermal Index and ALARA 32 blood perfusion and 33 time measurements 36 tipping and overbalance warning 11 warning symbol 7 touch screen adjusting 39 training before using equipment 9 transducer sockets warning about covering 26 transducer electrical safety 26 transperineal biopsy warning about checking matrix 30 warning about user defined matrixes 30 warning to verify matrix type and coordinates 30 turning system off and on See Getting Started Type B non isolated transducers warning about 26 Type B symbol 8 Type BF symbol 8 Type BF defibrillator proof symbol 8 U UA1225 See battery UA1247 See battery charger station UL symbol 7 8 USB saving to See Getting Sta
66. uide BB1756 M A Doppler gate large enough A Doppler gate over only one vessel A Doppler spectrum aliasing WARNING VFI 4 Check to make sure that the Doppler gate covers the entire vessel Otherwise the real time volume flow measurement may not be precise WARNING VFI 5 Check to make sure that the Doppler gate only covers one vessel Otherwise the real time volume flow measurement may not be precise WARNING VFI 6 Check to make sure that the Doppler spectrum does not alias Otherwise the real time volume flow measurement may not be precise Puncture and Brachytherapy A Verify transducer type number A Verify puncture guide type number A Watch the needle tip A Offset changes Flex Focus 1202 User Guide BB1756 M WARNING P 1 Before you start to image verify that the type number of the transducer matches the number displayed on the monitor If they do not match the puncture line on the monitor may not correspond to the true puncture path in the tissue In case of any inconsistency stop imaging turn off the system and contact your local BK Medical representative WARNING P 2 Verify that the type number of the puncture guide displayed on the monitor corresponds to the puncture guide that you are actually using If the number is incorrect the puncture line on the monitor may not correspond to the true puncture path in the tissue WARNING P 4 The puncture line on the ima
67. unless you follow these ESD electrostatic discharge precautionary ESD procedures e Discharge your body to ground before you touch the pins with your hand or a tool For example touch an unpainted metal part of the system cover e You can use a wrist strap connected to the additional protective ground or potential equalization terminal on the system if that is more convenient 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 Electrical Noise AN Electrical noise WARNING EN 1 Electrical noise from nearby devices such as electrosurgical devices or from devices that can transmit electrical noise to the AC line may cause disturbances in ultrasound images This could increase the risk during diagnostic or interventional procedures Electromagnetic Interference A Other equipment nearby 12 Chapter 2 Medical electrical equipment requires special precautions regarding EMC electromagnetic compatibility 6 You must follow the instructions in this chapter when you install the system and put it into service If the image is distorted it may be necessary to position the system further from sources of electromagnetic interference or to install magnetic shielding WAR
68. y is introduced by the selected step size that is the distance between organ cross sections Flex Focus 1202 User Guide BB1756 M Safety Information 35 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 e Transducer geometry e Rounding of results e Resolution of digital image memory 3D Measurements The 3D volume is found by summing the marked area in the individual slices and multiplying by a factor that includes the distance between the 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 The volume accuracy in the table is given as a percentage of the captured 3D volume accuracy starting with the first slice and ending with the last slice that intersects the object of interest If the 2D ROI region of interest is set to be much larger than the object the accuracy as a percentage of the object volume can be much worse higher percent NOTE To ensure that the accuracy of your volume measurement is as high as possible make sure that

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