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Pro Focus Ultrasound System

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1. Depth k Table 3 5 Function of the B mode Adjustment keys on the control panel Pro Focus 2202 User Guide BB1247 V The User Interface 57 Power and Color Mode Keys The Power and Color Mode keys are placed to the left above the trackball For detailed information about using them see the Pro Focus 2202 Extended User Guide BB1279 Power and Color Mode keys Figure 3 7 The Power and Color Mode keys on the control panel Powerand Key Name Key Type Action Color mode keys Table 3 6 Function of the Power and Color mode keys on the control panel Doppler and M Mode Keys The Doppler and M Mode keys are placed to the left of the trackball For detailed information about using them see the Pro Focus 2202 Extended User Guide BB1279 58 Chapter 3 February 2014 Pro Focus 2202 User Guide BB1247 V Doppler and M mode keys Figure 3 8 The Doppler and M mode keys on the control panel Dopplerand Key Name Key Type Action M mode keys Table 3 7 Function of the Doppler and M mode keys on the control panel Doppler Adjustment Keys The Doppler Adjustment keys are grouped on the left side of the control panel For detailed information about using them see the Pro Focus 2202 Extended User Guide BB1279 Pro Focus 2202 User Guide BB1247 V The User Interface 59 Doppler Adjustment keys Figure 3 9 The Doppler Adjustment keys on the control panel Doppler Key Name Key Type Action Adjustmen
2. User Guide ok medical Type 2202 Pro FOCUS Ultrasound System English C 0543 BB1247 V 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 If you have comments about the user documentation please write to us at the email address above We would like to hear from you 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 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 SUFFICIENT TESTING TO DETERMINE THAT THE SOFTWARE IS SUITABLE FOR USE e 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 Admi
3. 3 Click Save Selecting or Changing the Imaging Mode The system is set up to start imaging in B mode unless something else is specified in the Pro Package you are using To add modes to B mode press the key for the mode you want to add Performing a Biopsy or Puncture Procedure including Brachytherapy Brachy matrix or transperineal matrix A Check puncture guide type number A Watch the needle tip A Verify matrix type and coordinates A Verify matrix alignment Pro Focus 2202 User Guide BB1247 V When you use a puncture guide to perform a biopsy or puncture procedure a puncture line is superimposed on the image When you use a transducer for brachytherapy or prostate transperineal biopsy a needle guide matrix 1s superimposed on the image WARNING Always check the type number of the puncture guide displayed on the monitor to make sure that it 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 The puncture line on the image 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 in order to see tissue close to the transducer with high magnification depending on your Settings the needle tip echo can be outside the di
4. click something on the monitor point at it and press e The o key can be used to select items from lists or menus on the monitor of it clicking pressing Y selects the control so that the trackball can move it Click again to deselect the control or selection Usually this means that the trackball can move the pointer again e Ifthe pointer points at a Poh sel control such as the color box or one corner e Ifthe pointer points at an On Off type on screen control such as B Color pressing s toggles the control off and on Click long Some operations require you to point at something on the monitor and then press long o See Press long on page 53 This is indicated in this user guide as click long Key key When the pointer points at a control on the monitor pressing changes settings such as values or sizes A single press increases or decreases values stepwise A continuous press causes the value to keep changing Pressing the right side of the key increases a value pressing the left side decreases it If the key is pressed for more than Y second the action starts repeating 54 Chapter 3 February 2014 Pro Focus 2202 User Guide BB1247 V When the cursor points at Pressing the key a softkey whose value can be changed a graphical control such as the color box an item on alist Table 3 2 Effects of pressing the key For more details about using the
5. A Caution or Warning BA Consult instructions for use Manufacturer sal as S Fie UL Classification for Mus 3D56 Canada and US Potential Equalization J Ground earth Type BF A Type BF Type B R IP Sealing ly Standby gt Non ionizing radiation STERILE STERILE S Not watertight ESD electrostatic s VR discharge WEEE waste E Pro Focus 2202 User Guide BB1247 V Description Consult accompanying user guide BB1279 when you encounter this sign on the instrument to avoid reducing its safety Consult user guide or other instructions Legal manufacturer UL approval of medical equipment with respect to electrical shock fire and mechanical hazards Terminal connected to the chassis Should be connected to corresponding terminals on other equipment to eliminate potential differences Additional protective ground earth BF Isolated from ground Maximum patient leakage current under e Normal condition lt 100 uA e Single fault condition lt 500 uA BF defibrillator proof B Maximum patient leakage current under e Normal condition lt 100uA e Single fault condition lt 500uA Dust and immersion protected according to EN 60529 1 Standby switch on front of system used to turn system on and off Ultrasound system emits acoustic radiation Device is in a sterile condition Plug may not be immersed unless it is covered with a special watertight plug cover Do not tou
6. AN 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 the Setting Up and Customizing Your System chapter in the Pro Focus 2202 Advanced User Guide BB1946 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 W1 F1 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 in the lower middle part of the screen of the main screen View Exam View Archive To connect to a wireless network click the Wi Fi logo choose the appropriate network and type in the password 1 Wi Fi on Pro Focus 2202 UltraView systems has not been licensed by Health Canada 22 Chapter 1 February 2014 Pro Focus 2202 User Guide BB1247 V Mot Connected Connections are a Cp RIC_NET up ALOGWIFILAN 9 HP85E4 40 up BK Guest_N You only have to type in a password the first time you connect to a 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 The bars in the Wi F1 logo represents the signal strength The more lit bars in the Wea
7. The connections must follow the guidelines given in EN 60601 1 1 1 References 1 EN 60601 1 1 2001 Medical electrical equipment Part 1 1 General requirements for safety Collateral standard Safety requirements for medical electrical systems 2 EN TEC 60601 1 1990 A1 1993 A2 1995 A13 1996 Medical electrical equipment Part 1 General requirements for safety EN IEC 60601 1 2006 3rd Ed Medical electrical equipment Part 1 General requirements for basic safety and essential performance 82 Chapter 4 February 2014 Pro Focus 2202 User Guide BB1247 V Appendix 1 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 Indications for Use The system is intended for use by qualified physicians for ultrasound evaluation Specific clinical applications and exam types include the following types of imaging e Abdominal e Adult cephalic 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 Contra
8. To remove the monitor base 1 Make sure that the system wheels are locked 2 Move the monitor base to the top position 80 Chapter 4 February 2014 Pro Focus 2202 User Guide BB1247 V 3 Disconnect 2 monitor connections on the rear panel of the system the VGA1 connector and the power cord see Fig 4 2 4 Disconnect 2 monitor base connections internal connection and USB for DVD writer at the top right of the rear panel see Fig 4 2 5 Remove the 2 sliding covers from the system see Fig 4 5 6 Usea TORX 30 screwdriver or an NV4 Allen key to remove the 2 screws on the hook bars see Fig 4 7 that are attached to the back of the monitor base 7 Loosen the 2 black screws on the hook bars Do not remove them 8 Hold the monitor base under the DVD drive and lift the hook bars carefully out of the grooves To replace the monitor base 1 Make sure that the system wheels are locked and that the sliding covers are removed 2 Slide the hook bars of the monitor base into the grooves see Fig 4 7 Make sure that the hooks are in place at the top of each groove so that the monitor base 1s supported correctly 3 UseaTORX 30 screwdriver or an NV4 Allen key to screw the 2 screws into the hook bars hook hook bar uia grooves a TORX screw black screw Figure 4 7 Hooks and grooves for holding monitor base 4 Tighten the black screws on the hook bars 5 Replace the sliding covers 6 Onthe rear of the system reconnect t
9. WARNING 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 WARNING Check to make sure that the Doppler gate covers the entire vessel Otherwise the real time volume flow measurement may not be precise WARNING Check to make sure that the Doppler gate only covers one vessel Otherwise the real time volume flow measurement may not be precise WARNING 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 WARNING Ifyou create a user defined brachy matrix it is your responsibility to verify that the matrix that appears on the monitor corresponds to the physical brachy matrix you are using WARNING Changes you make to the offset of a programmable puncture guide or brachy matrix will affect ALL programmable puncture guides and brachy matrices This could lead to incorrect puncture lines or matrix positions for a different guide than the one you wanted to change 3D Safety Considerations Pay particular care to the following safety issues when operating the 3D system For more detailed 3D operating instructions see the Extended User Guide WARNING You cannot make accurate measurements on a 3D data set acquired using the untracked free
10. 2001 A1 2005 A42 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 February 2014 Pro Focus 2202 User Guide BB1247 V 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 equipment Part 1 1 General requirements for safety Collateral standard Safety requirements for medical electrical systems S 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 T
11. Doppler mode for information about flow direction and velocity Power mode power Doppler mode for higher sensitivity to flow information includes directional Power Doppler Doppler mode spectral Doppler mode for information about the spectrum of flow velocities as a function of time CW Doppler mode continuous wave Doppler for information about high velocity flow M mode for information about tissue motion as a function of time NOTE Not all imaging modes may be available with your version of the system Pro Packages Pro Packages contain default presets and calculation formulas that make it quick and convenient to use the system for specific applications Pro Focus 2202 User Guide BB1247 V General and Safety Information Safety Symbols on the System Important safety information is indicated in the user guide and on the system itself by means of special symbols and formatting Table 1 3 contains brief explanations of the symbols used to label the system Some labels in the table may appear on the transducer rather than the system itself NOTE especially the following Z When you encounter this sign on the system consult the user guide for important safety information BK Medical disclaims all responsibility for the operating safety reliability and performance of the equipment 1f these symbols and warnings are disregarded in any way 10 Chapter 1 February 2014 Pro Focus 2202 User Guide BB1247 V Symbol Name
12. Out gt RGBS Only one piece of external equipment can be connected to the RGBS connector Video camera RGBS In RGBS Video camera Composite In de Video camera S VHS In Table 4 3 Overview of video documentation connections Pro Focus 2202 User Guide BB1247 V Technical Guide 75 Documentation Trigger Connectors In order to use the foot switch or key to print the image on the monitor connect 711 or Yel 2 to the trigger input of a video printer USB Devices USB Images can be saved to a USB storage device through the USB connector on the left connector side of the DVD drive under monitor External hard The power available from the USB connector on the left side of the DVD drive is drive limited If you are using an external hard drive attach only a data transfer cable to this connector Do not use it for supplying power to the hard drive AN Caution Do not attach 2 USB storage devices for example a memory stick and an external hard drive to the system at the same time Consult your BK Medical service representative if you have questions about connecting an external hard drive The DVD writer built into the monitor base is connected to the de connector at the top right of the rear panel de connector A on the back of the system 1s reserved for use with USB printers black and white or color de connector B on the back of the system is reserved for use with the optional 3 pedal foot switch NOTE
13. Zhe USB ports on the system are USB 2 0 ports However in order to get high speed performance the equipment you connect to them must be labeled certified Hi Speed USB Foot Switch Connector There are two connectors for the optional foot switches see page 66 one for a 2 pedal and one for a 3 pedal foot switch see Fig 4 2 on page 73 Electrical Connections Power Supply Cord The system comes with a power supply cord that 1s specific to your region The connector see Fig 4 3 is on the lower left side of the rear panel 76 Chapter 4 February 2014 Pro Focus 2202 User Guide BB1247 V 100V 230V o 50 60Hz S00VA 100V 230V 2x TIA i Figure 4 3 The connector for the power supply cord AN WARNING Use only the power supply cord that comes with the system Never use extension cords The increased length of the cord will increase the resistance of the Use only protective ground conductor and may increase the equipment s leakage current beyond original an acceptable level power supply cord The power supply cord for the USA has a hospital grade 3 prong grounded power plug Contact your local BK Medical representative 1f you need a different plug or 1f the cord is missing or damaged JX WARNING Never try to remove or change the plug on the power supply cord Don t change power plug Cord Retaining Kit UA2204 The optional cord retaining kit UA2204 1s attached to the power supply socket to en
14. as inside the patient s body WARNING 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 EN60601 2 37 3 To avoid this freeze the image when the transducer is not used for imaging WARNING C J 1 Creutzfeldt Do not use a transducer for neurosurgical applications if the patient is suspected of having Jakob Creutzfeldt Jakob disease If a neurosurgical transducer has been used on a patient disease suspected of or diagnosed as being Creutzfeldt Jakob positive the transducer must be destroyed following approved procedures for your hospital Care Please refer to the Care Cleaning amp Safety manual for information about caring for transducers Remote Control A Active ata distance A 16 Chapter 1 If you use a wireless remote control UA 1237 with the system be sure to read about how to use it in Chapter 3 The User Interface The remote control uses short wave radio waves to communicate with the system WARNING 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 This device complies with Part 15 of the FCC Rules Operation is subject to the fol
15. content of the report will vary depending on the Pro Package and the measurements you have made F1 o F10 Displays an arrow on the image and allows you to add text to the image Table 3 12 Default function of the F8 and F10 keys Pro Focus 2202 User Guide BB1247 V The User Interface 63 Controls on the Monitor Image area Identification area Data area Image Documenta tion area Image and Measurement 64 Chapter 3 area Image area Data area Image and measurement area Browser area Same function as E Same function as on the control panel on the control panel Figure 3 14 The parts of the display on the monitor The layout shown here may be different from the one on your monitor e The Ultrasound Image area is in the center This area displays the current Imaging and or frozen views Graphical on screen controls such as the zoom box color box and focus indicator are located in this area e The Identification area is at the top This contains identifying information about the hospital and patient the date and time the transducer type and imaging frequency and imaging plane for a biplane transducer and the name of the Pro Package and preset e The Data area is on the left side It displays data that must be documented with the image Information displayed in this area is automatically updated The Data area has a data section at the top that contains the relevant settings for image
16. only applicable when there 1s 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 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 in order to comply with requirements Some of the system functions can affect the acoustic output as listed here Instructions for using these functions are given in the relevant sections of this user guide e Sizing functions such as ROI region of interest in general smaller size results in higher aco
17. to another location To dock the LCD flat screen 1 Standing in front of the system maneuver the flat screen on the arm so that the front of the monitor is over the front of the system body 2 Holding the monitor handle guide the monitor back 3 Still holding the handle press so that the monitor clicks into place AN Caution Avoid using excessive force when docking the flat screen monitor 34 Chapter 2 February 2014 Pro Focus 2202 User Guide BB1247 V AN Caution We recommend that you dock the flat screen monitor before you wheel it around the hospital AN Caution Do not put any weight on the arm nor use it as a lever The arm is only designed to support the weight of the flat screen monitor Turning the System On and Off To turn the system on and off use the green standby switch on the front of the system To turn the system on e Press the standby switch ONCE A startup screen with progress bar is displayed Wait until the startup screen disappears and the display on the monitor 1s stable indicating that the system is ready to use Do not try to use the system until it 1s fully ready To turn the system off e Make sure the system is completely up and running Then press the standby switch ONCE AN Caution Whenever you turn the system on or off you must give the operating system of the system PC enough time to save and recover open files and unsaved data Otherwise a Wait after serious system failure may
18. 1s reset to the default for the transducer If for some reason you want to keep the current settings when you start imaging the new patient you can prevent the settings from being changed back to the default ones However this does not work if you change transducer or Pro Package To keep transducer settings e Check Keep image settings in the Patient window The system uses the image settings from the previous patient Pro Focus 2202 User Guide BB1247 V Getting Started 41 Keeping Patient Related Data When you enter a new patient ID the patient related data are reset to the default values Patient related data include the following e preset Bodymark e Measurements e Labels You can start a new examination with the patient related information from the current patient To keep patient related data 1 Atthe bottom of the Patient window click Edit 2 Anew checkbox Keep patient related data appears Make sure that it contains a checkmark The system uses the patient related data from the previous patient You can edit the information including changing the patient name NOTE You must check both Keep image settings and Keep patient related data if you want to return to the previous frozen image when you Close the Patient window If you do not check both boxes the system starts imaging when you close the window and measurements you have made are lost Pausing and Later Continuing an Examination It is possible to pause a
19. 4 Then press p to increase or press X 4 to decrease brightness Subsequent presses either increase or decrease the brightness Factory Defaults If the monitor image appears skew or too large or the brightness and contrast settings appear incorrect you can restore the factory default settings OnLCD To restore the factory default settings on the LCD flat screen monitor monitor 1 Click View Archive at the bottom left of the monitor 2 Point at USB Eject do NOT click so the frame around the monitor control becomes visible 3 Press AUTO twice Menu Window on LCD Flat Screen Advanced On the flat screen monitor advanced options which enable you to finely tune the options appearance of images on the monitor are available via the Menu window For most users it is not necessary to adjust these settings because the default settings provide the optimal ultrasound image in most cases Contact the hospital technician or a BK Medical service representative to adjust the gamma settings or the aspect ratio controls Adjusting the Reading Lights After you have turned on the system you can adjust the brightness of the 3 reading lights under the DVD drive See Fig 2 1 To adjust the reading light brightness e Click Light under Image on the right side of the monitor and drag the slider or point at Light and press Setting up a New Patient Before you image a new patient you must open the Patient window a
20. Brachy Ruler with Sagittal Plane Imaging You can set up the system so that a brachy ruler is displayed when you image in the sagittal plane with the 8848 transducer in situations where a brachy matrix appears in the transverse imaging view EZ BR Medical 2a 1 200 E6585 Pro Urology ZY John Smithson 181144 21 53 58 6 5 MHz Setup Prostate 6 5 ss a 6 9 cm gt Tm B E Medical m Prog 1 7f 4 G amm MIT 1 00 lt 1 50 TIS 1 02 0 S 4 4 4 F Res Hz 2 25 Hz a AS eae ain RE a a 4 4 4 F el A 1 ee E Rc E i A B A A R 5 i 0 4 cre 1 E 1 1 I 1 1 1 1 I 1 1 1 I 1 gt o 1 2 Plog LAAG 5mm an a I0 10 04200 30 40 em E 1 I 1 nn Ti AA T 1 1 ooo LISB Eject EEE AH View Delete Copy ED Archive CD DICOM Print Capture Image Capture Clip Join a View Exam View Archive eo Figure 2 12 A split screen view with transverse brachy matrix above and sagittal brachy ruler below Ruler has vertical line to mark 0 The sagittal brachy ruler is sometimes displayed with a 2 dimensional grid to make it easier for you to see the horizontal position of the needle no matter where it is in the vertical direction To move the ruler to the left or right 1 Click the zero position on the horizontal bottom axis 2 Drag the vertical line that replaces the ruler markers Pro Focus 2202 User Guide BB1247 V Getting Started 3 Click when the l
21. EN IEC 60601 1 2 It also complies with UL 60601 1 4 and CSA C22 2 No 601 1 M90 5 It fulfills 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 physician WARNING If at any time the system malfunctions or the image is severely distorted or degraded or 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 wall and make sure it cannot be used until it has been checked e Donottry to repair the system yourself e Contact your BK Medical representative or hospital technician WARNING The power supply cord connects the system to the line voltage To isolate the system you must unplug the power supply cord from the wall outlet Do this before you try to make any repairs to the system February 2014 Pro Focus 2202 User Guide BB1247 V A Conden sation 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 Wait at least 2 hours after the system has been subjected to major changes in temperature or humidity e If there is visible evidence of condensation wait at least 8 hours Before you use the s
22. MOMMAUON dis 8 Typographical Conventions 0 AA AE 8 ui AAA Se cae ae EE atti aad a 8 ADOULIME SYSLEM et ey Go Cae ee ee 9 Mae thie WOU SS gga ether deca ae A eae EE EA ee ee 9 Pro Packa nEs srar cums she hap ean auth he ea prada 9 Safety Symbols on the SYSlCM west ecw eau ewst oda bee dee Kees 10 CE M rks n Electrical DEVICES 4 i ia A 248 e eek reese 12 General Safety Precautions cata dus cag verses see ade 12 Explosion Hazards cuca 13 Elccmical Sate AA A Oh eae eae A 13 ESTAMOS sn 14 e AA iui meee eine Had doe ape hare enh an yaaa hod 14 TAStAHAHOM prada be hua et RAN 15 PP O aA ae ee 15 Remote CORO n E aos 16 Other Salety ConsiderationS esogeni nne es 17 Service and REPAMAR Elida 19 Connecting Other Equipment irnos E cd 20 Network CONMMECUON dsicojidia ri bed ria da 20 NG A O noe Rs ee 21 NE PINON dadas 21 Si a cesena eea e r Bid S TE T 21 Wireless NOIWOIKS das id 22 ACOUSIIC OMPI AVE a See oe 24 A speserei eee ea ener rab hear a a A 24 Montor DEPA paa Taa a a aaa a teS 25 Thermal and Mechanical Indices o oooooooooooooomooooo 26 Acoustic Output Measurement 0 00 c ccc ee mom 26 Functions Affecting Acoustic Output 0 0 0 0 0 ccc eee 21 Default Acoustic QUIPUE asentar athe wade ss 28 Clinical Measurements Ranges and CCULacIes o ooooooooooooooo 28 Geometric Measurements tia a ri Wels 29 Time Measurement enn ao aria 30 Doppler Measurement aid Ea 30 GIChONCCS e a ue hee tama neo se ween
23. User Guide BB1247 V The User Interface 67 When pairing 1s 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 1f the remote control is taken away to be disinfected Pairing lasts until you pair the remote control with another system or pair another remote control with the system Therefore it 1s 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 th
24. at supplies buildings used for domestic purposes Electrical Noise WARNING 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 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 WARNING 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 EMC noise can reduce the usable image depth Therefore in order 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 February 2014 Pro Focus 2202 User Guide BB1247 V A RF Radio Frequency Interference Po
25. ate Accession Nu Reg Last First Mid Smith John Pro General Patient ID Setup Abd Res 1 2009041 a Reg Proc Code Mean Reg Proc Code al Sch Prot Code Mean Sch Prot Code al Pac NA ON We Ne PEI C Keep image settings Edit Discontinue Examination OK Cancel Figure 2 6 The Patient window with worklist Depending on how your DICOM system is set up the worklist may appear as soon as you open the Patient window If the worklist is blank you can retrieve the information To retrieve a worklist 1 Use the drop down window in the upper right corner to select the dates or the patients you want the list to include If you choose the Patient option in the drop down window you can filter the information so that only certain patients are displayed by entering patient name patient ID accession number and procedure ID in the appropriate fields NOTE The Accession Number and Req Procedure ID fields do not appear by default You must activate the fields in the Patient Setup window click Customize under Image on the right side of the monitor Then click the Patient tab 2 Click Update The worklist appears in the window If there are more patients than can fit in the window you can scroll down to see the rest of the list To sort the worklist by name or any other column in the worklist click the column heading To select a patient from the worklist 1 2 Click the row that con
26. ated power necessary to raise the temperature of the target tissue one degree Celsius W C As a rule of thumb the Thermal Index TI indicates the highest expected 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 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 and AIUM NEMA display standards 3 9 10 For the some of the acoustic parameters an estimated in situ derated value is given This is derived assuming a tissue attenuation of 0 3 dB cm MHz when the estimated in situ derated value I is described by the following equation February 2014 Pro Focus 2202 User Guide BB1247 V Iformula I I exp 0 069fz 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 is maximum It should be stressed that the in situ values given are
27. ch pins in connectors with this symbol unless you follow ESD precautionary procedures Within the EU when you discard the equipment you must send it to appropriate facilities for recovery and recycling General and Safety Information 11 Symbol Name Description China ROHS 25 Years Environmentally Friendly Use Period for ROHS is 25 Lifetime years Specified Radio On remote control UA1237 This equipment Equipment conforms to Japanese Radio Law regulations Aa EA SMT oNN Sey concerning frequency and power Table 1 3 Symbols on the system CE Marks on Electrical Devices The European Union has introduced directives requiring C marks on devices Non medical devices marked with C comply with relevant directives for example EEC Council Directive 89 336 EEC of 3 May 1989 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 Ia IIb and HI BK Medical defines classes assuming imaging duration for individual patients does not exceed 60 minutes General Safety Precautions A A Equipment failure A Isolating the 12 Chapter 1 system The ultrasound system is designed and tested in accordance with EN IEC 60601 1 2 and EN 60601 2 37 3 It complies with requirements for Class 1 protective earth devices of
28. d at the end of the chapter Terminology Instructions You control the system by using the graphical user interface on the monitor pressing keys on the control panel or typing on the keyboard Instructions in this user guide tell you what sort of action to take 8 Chapter 1 February 2014 Pro Focus 2202 User Guide BB1247 V When the instructions say It means Click Power Use the trackball to point at the Power on the monitor and then press i Select on the control panel Press Power Press the Power key on the control panel Press Sound A Press the Sound key on the control panel Type Power Type the word Power on the keyboard Table 1 2 Click Press and Type About the System 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 The Pro Focus 2202 Ultrasound System 1s easy to use You can perform most system operations using just the trackball and the trackball keys to interact with controls on the monitor Dedicated keys on the control panel make other operations quick and easy Imaging Modes The Pro Focus lets you use various imaging modes B mode brightness mode for real time imaging of soft tissues includes harmonic imaging and IQPAC with Enhanced Tissue Definition ETD and Angular Compound Imaging ACI Color mode CFM color flow mapping color
29. e Thermal and Mechanical Indices on page 26 Quality of Printed Images Caution The quality of a printed ultrasound Image may vary depending on the printer Service and Repair A Authorized personnel Pro Focus 2202 User Guide BB1247 V WARNING Service and repair of BK Medical electromedical equipment must be carried out only by the manufacturer or its authorized representatives BK Medical reserves the right to disclaim all responsibility including but not limited to responsibility for the operating safety reliability and performance of equipment serviced or repaired by other parties After service or repairs have been carried out a qualified electrical engineer or hospital technician should verify the safety of all equipment General and Safety Information 19 Connecting Other Equipment WARNING Consult this user guide before connecting other equipment to terminals marked with To fulfill EMC requirements do not attach cables to the system unless they are the same type as listed in Table 4 2 on page 74 and do not exceed the maximum length given in the table 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 The system must not be galvanically connected to a compute
30. e sagittal transverse or endfire The current imaging plane T S or E is displayed on the at the top of the monitor after the transducer type number To select the imaging plane e Press the appropriate button on the transducer For details see the user guide for the transducer or e Click T S or E whichever is displayed on the monitor and select the value you want or point at T S or E and press The imaging plane in the selected view is updated to the one you select Pro Packages and Presets Each Pro Package contains all the measurement and calculation tools you need for a particular application area It also contains appropriate presets for the various transducers that can be used with the Pro Package Each transducer may have more than one preset but one setup will be the default one The following Pro Packages are available on the system e Abdomen e Pediatric e Brachy e Pelvic Floor e Cardiac e Regional Anesthesia UGRA Anes e Colorectal e Small Parts e MSK e Surgery e Neuro e Urology e OB Gyn e Vascular These Pro Packages are available on the Pro Focus 2202 UltraView 800 system only A preset contains information about the imaging modes that are being used and all the imaging information for those modes Pro Focus 2202 User Guide BB1247 V Getting Started 45 Selecting a Pro Package or Preset The system starts imaging with the default preset for the transducer and Pro Package you are
31. e cursor is on the object then press Select Replacing Batteries To replace the batteries in the remote control 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 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 Cleaning and Disinfection For details of cleaning and disinfecting the remote control see Care Cleaning amp Safety 68 Chapter 3 February 2014 Pro Focus 2202 User Guide BB1247 V Transducers Control Some transducers have a control button that you can press to Start or Stop imaging button freeze frame Long press You can set up your system so that a long press more than one second starts one of the user defined documentation functions such as capturing an image See the Pro Focus 2202 Extended User Guide BB1279 for information about setting up user defined keys If the transducer has more than one control button you can set up a user defined long press function for each control button Each time the control button is pressed a beep is emitted Pro Focus 2202 User Guide BB1247 V The User Interface 69 70 Chapter 3 February 2014 Pro Focus 2202 User Guide BB1247 V Chapter 4 Technical Guide This chapter contains information about the electrical requirements and operating conditions for the system as
32. e to faulty or overloaded network see training requirements warning on page 25 e System overloads the network causing other equipment to fail Network NOTE f 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 on a separate network Otherwise you could risk overloading the network and your equipment failing Network Printing For printing on network printers BK Medical support protocols PCL 5 PCL 6 and PS Post Script Computer Security A Check external media When the Pro Focus 1s connected to a hospital network BK Medical does not take any responsibility for computer viruses from the network that may infect the Pro Focus We recommend that the system 1s protected by a network firewall Caution You must perform a virus check on any external storage medium USB device or CD to make sure that it is virus free before you connect it to the system Pro Focus 2202 User Guide BB1247 V General and Safety Information 21 Wireless Networks The system can be connected to a wireless network for printing and archiving data This requires the optional wireless license for the system and a Wi Fi adapter that is supplied by BK Medical when you buy this option The Wi Fi adapter is inserted into one of the USB connectors located on the rear of the system see Fig 4 2 in Chapter 4 Technical Guide on page 71
33. ee 30 Getting Started cirri ennaa ian avasavanaaaanererhwawkwawuerewasaes 33 General OMA OR A ea A SETIT ERSE 33 Adjusting the Keyboard Panel and Monitor ooo ooooooooooooooo 34 Docking the Flat Screen on Arm oooo oooooomoommomono 34 Turning the System On and Off AA A 35 SY Sich DUS 5 25 a Aid 35 Chapter 3 CHECKING ING Dates idiota 35 SENES On the MONTO iria ed 36 BAN S Seaan eae eines a a e eae emp oe E E eae Oe 36 Factory Der eeren aea O E nai 37 Menu Window on LCD Flat Sereen oo ooooooooonoomomm o 37 Adjusting the Reading Lights 1000 bse hee see Ree ewe tae at 37 Setting up a New Patient 0 eect n eens 31 Opening the Patient WNIdO Wear 38 Changing Pro Package or Preset in the Patient Window 38 New Patient Information from a DICOM Worklist 39 EntermelDales errada aa eee SEE 41 Keepine Image SeUiIn GS 2er e oan eee we ie 4 Keeping Patient Related Datars 44 42 32 beeen heane ee shea es okt ees 42 Pausing and Later Continuing an Examination 0006 42 Discontinue Examination with MPPS Server Configured 43 Ending an EXAMINE he eee eae a eS 43 Connecting and Selecting Transducers 0 0 0 ccc ccc eee nee 43 Connecting a A ransducer ss iast oe nas ias eii 43 DeleCuiG aM hansducen sii ia dt es Bee ae aS 44 Selecting the maso Plane rr Shh eR Se keh bas 45 Pro Packages and Presets atadas irte 45 Selecting a Pro Package or Pre
34. ements 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 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 Pro Focus 2202 User Guide BB1247 V General and Safety Information 29 Distance and area accuracy 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 Zo ensure that the accuracy of your volume measurement is as high as possible make sure that the object you are interested in fills the region of interest as much as possible The accuracy of a distance measurement on a 3D image will never be better than 6 the accuracy of an area measurement on a 3D image will never be better than 6 In the table in Technical Data BZ2100 the overall measurement accuracy for a full range measurement 1s given in the right hand column for each measure
35. fulfills the requirements specified in UL60601 1 4 limit of 300 uA If power is not supplied in the way specified the leakage current can be as high as 500A the limit specified in EN IEC 60601 1 2 WARNING Never remove the cover to get access to the inside of the scanner You risk electrical shock if you do so Do not allow anyone but qualified service personnel to service the scanner Pro Focus 2202 User Guide BB1247 V General and Safety Information 13 ESD Training ESD The ESD Symbol 2 Anyone using the equipment must be able to recognize the ESD symbol des and understand how to take the necessary precautionary procedures as described in the caution below ie s Caution Do not touch pins in connectors that have the ESD symbol 4ra Do not connect anything to them unless you follow these ESD electrostatic discharge precautionary 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 scanner if that is more convenient Interference A Electrical noise A Other equipment 14 Chapter 1 nearby The Pro Focus 2202 Ultrasound System is suitable for use in all establishments other than domestic establishments and those directly connected to the public low voltage power supply network th
36. ging 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 User Documentation Before using the system 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 System Extended User Guide Information about advanced functions glossary Product Data for system Specifications forthe 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 punc
37. given in the table Pro Focus 2202 User Guide BB1247 V Technical Guide 73 Symbol Connector Partmumber TypeandMaximum Length Color Composite Out Shielded 3 m Color Composite In Shielded 3 m C BW Composite Out Shielded 3 m eee S VHS In Shielded 2 m S VHS Out Shielded 2 m Audio In Shielded 2 m G Audio Out Shielded 2 m gt VGA 2 Out AO 1382 Shielded 2 m C RGBS Out AO 1382 Shielded 2m RGBSIn AO 1382 Shielded 2m zl Documentation Trigger 1 EL4020 Shielded 1m zl Documentation Trigger 2 EL4020 Shielded 1m al DICOM Included in DP0925 Shielded 3 m dJe USBA Shielded 3 m Jo USBB Shielded 3 m gt RS232 Shielded 3 m ECG wire on front panel AO0366 Shielded 3 5 m Table 4 2 List of cables used in testing for EMC compliance The system monitor is connected to the VGA1 connector The power to the monitor comes from one of the auxiliary power outlets See page 78 You can use the lt gt VGA2 connector for an external VGA monitor itout An audio Doppler signal is available from the gt L and R connectors L WA A A lA ve Fe A amp q G ANC iS Y EM ll ww The speakers are connected to an internal amplifier built into the monitor base and connected to the gt connector at the top right of the rear panel via a multi cable To record an audio signal connect the gt connectors to a video recorder To play a recorded signal back through the system speake
38. hand method February 2014 Pro Focus 2202 User Guide BB1247 V Warning on monitor A 3D measure ments A Do not cover patient ID or other important information A High acoustic output during Bubble Burst A Print quality 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 to remind you that the measurement will not be accurate Aya po WARNING 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 systems 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 Picture in Picture WARNING When you use Picture in Picture do not cover critical information such as TI or MI on the monitor Make sure that all important information will appear if you print or save the ultrasound image Contrast Imaging Caution When you turn on Bubble Burst the acoustic output limits are increased to 1 9 MI This change overrides any limits you have set During Bubble Burst the acoustic output will exceed normal contrast imaging values and may approach the higher Bubble Burst limits Se
39. he 2 connections to the monitor VGA1 and auxiliary power outlet and the 2 connections to the monitor base internal connector and top USB connector See Fig 4 2 HistoScanning The scanner units to be used with HistoScanning systems from AMD have an extra connector on the back of the system on the lower left side It 1s used to take raw data before it has been converted to an image on the monitor out of the system To use the Pro Focus for HistoScanning you must have a HistoScanning license installed 1 HistoScanning is not market cleared by the FDA for sale in the USA and not licensed by Health Canada Pro Focus 2202 User Guide BB1247 V Technical Guide 81 HistoScanning connector Figure 4 8 Connector for HistoScanning Using the System with a Lithotriptor You must have a license installed in order to use a lithotriptor with the system You must always follow instructions in the manufacturer s user guide for the lithotriptor Power Connections If you are using the system with a lithotriptor make sure that the lithotriptor complies with the guidelines in EN IEC 60601 1 2 Connect both the system and the lithotriptor directly to independent wall outlets Connecting the System to the Lithotriptor You can use the RS 232 connector on the back of the system see Fig 4 2 to connect a lithotriptor You must follow the connection instructions in the manufacturer s user guide for the lithotriptor system
40. he front of the system Replace the keyboard panel Pro Focus 2202 User Guide BB1247 V Technical Guide 79 Monitor Removing and Replacing an LCD Flat Screen Monitor To remove the LCD flat screen monitor from the base 1 Make sure that the system wheels are locked 2 Unplug the power cord and VGA connector from the back of the monitor 3 Loosen the 2 thumb screws on the bracket to expose approximately 5 mm of thread If metal screws have replaced the thumb screws in order to secure the flat screen monitor from theft use an Allan key to loosen these screws Figure 4 6 Loosen the thumb screws to remove the monitor from the base 4 Slide the monitor off the base To replace the LCD flat screen monitor 1 Make sure that the system wheels are locked and that the sliding covers are removed 2 Make sure that the two thumb screws on the bracket are loosened exposing approximately 5 mm of thread 3 Slide the monitor onto the base making sure that it is securely and completely on the base and is not crooked 4 Tighten the thumb screws until the flat screen is secured or tighten the metal screws using an Allan key WARNING Ifthe thumb screws are not tightened correctly so that they secure the l monitor the monitor can fall off and injure you or others when you move the system Monitor can fall 5 Plug the power cord and VGA connector into the back of the monitor Monitor Base Removing and Replacing the Monitor Base
41. holders release hordi handle hooks for cables standby switch Figure 2 1 The front of the system Pro Focus 2202 User Guide BB1247 V Getting Started 33 Adjusting the Keyboard Panel and Monitor You can easily adjust the position of the keyboard panel and monitor to make imaging comfortable for the operator Instructions vary depending on the type of monitor and keyboard you have Upanddown To adjust the height of the keyboard panel and monitor 1 Grab the panel on both sides and pull up on the two release handles see Fig 2 1 Move the panel up or down 2 Release the handles Angle To change the viewing angle of the monitor e Use the handle on the front of the monitor to swivel it from side to side and tilt the monitor up or down Adjusting resistance of the flat screen Figure 2 2 Thumb screw for adjusting resistance on the back of the LCD flat screen monitor To adjust the force required to change the viewing angle of the flat screen monitor e Usethe thumb screw on the back of the LCD flat screen to increase or decrease the monitor s sensitivity to angle adjustments Hand Rest The removable hand rest UA 0967 can be used to make working with the keyboard panel more comfortable See Care Cleaning amp Safety Docking the Flat Screen on Arm The flat screen monitor on the articulating arm can be docked This prevents it from moving around which is particularly important when the system is being moved
42. ial 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 February 2014 Pro Focus 2202 User Guide BB1247 V 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 1s not taken into account in this section In this case the system calculates and displays the convex hull of the figure that 1s the smallest convex figure containing the non convex figure outlined by the user see Fig 1 1 The system bases the calculation of the ellipsoid volume on the convex hull Figure 1 1 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 inaccuracy is introduced by the selected step size that is the distance between organ cross sections 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 Measur
43. ig 2 6 When you start to type the patient s name or ID the system searches the patient database for patient names that match the entered data A list of possible matches appears and you can select the one you want and click it or use the arrow keys on the keyboard to select it and press Enter To select the patient from the patient archiving system e Click next to the Patient ID field The Archive window opens Changing Pro Package or Preset in the Patient Window When the Patient window opens a default Pro Package and a default preset are displayed in the window February 2014 Pro Focus 2202 User Guide BB1247 V Click to save patient data and go to Pro Package menu window TAB to move between fields ENTER closes window Re opening Patient window To change Pro Package or preset in the Patient window 1 Point at the name of the Pro Package or preset 2 Press to toggle through the available choices If you click one of the default setups instead of toggling through the choices the data in the Patient window are saved and the Pro Package menu window appears You can select a different Pro Package and preset from the menu See Selecting a Pro Package or Preset on page 46 After you select something from the menu the Pro Package menu window closes If you have selected a new preset imaging begins If you have selected a new Pro Package the image 1s frozen when the Patient window closes Us
44. ime Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment AIUM NEMA 2004 11 Medical Ultrasound Safety AIUM 2009 12 ALARA Training Program Ultrasound III Training B K Medical 1993 13 Bioeffects considerations for the safety of diagnostic ultrasound Journal of Ultrasound in Medicine Vol 7 No 9 supplement September 1988 14 The safety of diagnostic ultrasound The British 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 Pro Focus 2202 User Guide BB1247 V General and Safety Information 31 32 Chapter 1 February 2014 Pro Focus 2202 User Guide BB1247 V Chapter 2 Getting Started General Information The system and the monitor menus shown in this user guide may look different from yours Before you turn on the system make sure that the installation has been approved by a qualified electrical engineer or hospital safety personnel See Installation on page 15 The controls you need to operate the system are located on the front y 7 gt A 1 handle on monitor 4 DVD CD RW USB gt ne connector reading lights gel holder transducer
45. indications The Pro Focus 2202 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 Pro Focus 2202 UltraView has not been CE approved or licensed by Health Canada Pro Focus 2202 User Guide BB1247 V 83 84 Appendix 1 February 2014 Pro Focus 2202 User Guide BB1247 V sal 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 i BK Medical brand name that advance medicine and save lives a NM a og 5 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
46. ine is positioned where you want the new zero position of the ruler The vertical line disappears and the ruler markers appear in their new positions NOTE You can set up the system so that a vertical 0 line is always visible along with the markers as shown in Fig 2 12 User Definable Matrix and Ruler You can also define your own matrix and ruler Remote Control For a description of the controls on the wireless remote control UA1237 and how to pair it with the system see Chapter 3 The User Interface The remote control uses short wave radio waves to communicate with the system Before you use it be sure to read the warning and other safety information in the section Remote Control on page 16 Cleaning and Disinfection For details of cleaning and disinfecting the remote control see Care Cleaning amp Safety 50 Chapter 2 February 2014 Pro Focus 2202 User Guide BB1247 V Chapter 3 The User Interface The Pro Focus system has 4 types of controls in addition to buttons on the transducers e keyboard panel controls keys e controls on the monitor e foot switch optional e keys on the optional wireless remote control This chapter gives an overview of the various controls and how they are used in general Detailed information about using individual controls is contained in the Pro Focus 2202 Extended User Guide BB1279 The monitor menus shown in this user guide may look different from the version o
47. ing a key normally and pressing it for a longer time at least one second have different effects The longer presses are indicated in this user guide by press long A long press usually turns off a function The Trackball and Trackball Keys The trackball together with the s Select keys and the key can be used to operate the on screen controls key trackball Select keys Figure 3 2 The trackball and trackball keys Trackball with Select Keys Likeamouse The trackball and o Select keys are used together like a PC mouse e Rolling the trackball moves the cursor and other objects on the monitor e Pressing one of the o keys 1s like clicking a left mouse button Pro Focus 2202 User Guide BB1247 V The User Interface 53 There 1s no difference between the o keys use the one that 1s most convenient for you Adjusting the Trackball The trackball should move smoothly If it 1s too tight or too loose use the trackball adjustment tool QA 0228 to adjust it trackball adjustment tool Figure 3 3 Using the trackball adjustment tool The tool is stored in the keyboard base below the keyboard panel To adjust the trackball movement place both ends of the tool into the small holes in the black ring of the trackball housing Turn clockwise to tighten and counterclockwise to loosen the trackball The ball can be removed completely for cleaning Select Keys Click When this user guide tells you to
48. ing the Patient Window After you have entered information in a field press Tab to move from field to field You can also move the cursor to a field by clicking the field Do not press Enter Return unless you want to close the window Enter on the keyboard 1s the same as OK in the window If you decide to enter more patient data after you have started the examination or if you have closed the Patient window by mistake before you have finished entering data you can re open the window To re open the Patient window click the patient name at the top of the monitor When the blank Patient window opens click Edit to restore the previously entered patient data to the fields NOTE Any information you enter after you re open the Patient window will not be transferred to the patient archiving system New Patient Information from a DICOM Worklist Pro Focus 2202 User Guide BB1247 V DICOM is not installed as a default on the system If DICOM is installed the system may be set up so that you can retrieve a worklist of patients and then select a patient from the worklist Caution Changing the DICOM setup can cause your system not to work properly For example you may be unable to print to a DICOM printer All changes to the DICOM setup should be made by qualified service personnel only Do not try to change the DICOM setup yourself Getting Started 39 40 Chapter 2 Sorting Worklist Update f 3 Days Birth D
49. ipment 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 electronics engineer or hospital safety personnel e Never use extension cords The increased length of the cord will increase the resistance of the protective ground conductor beyond an acceptable level e Keep power cords sockets and plugs clean and dry at all times Original Ifthe original power cords are missing or damaged you must order new ones from powercords your local BK Medical representative WARNING Make sure that the power supply cord cannot be accidentally disconnected from the wall or the system Secure the power supply cord Transducers A Electrical shock WARNING The transducer sockets contain terminals with 5V Do not touch the patient while you are touching an uncovered socket Pro Focus 2202 User Guide BB1247 V General and Safety Information 15 A Type B transducers A Electrical burns A Surface temperature on array A WARNING When using Type B non isolated transducers carefully check all electrical equipment within the patient area Also consider using additional protective grounding WARNING Do not leave transducers in contact with the patient when using HF electrosurgical equipment BK Medical transducers fulfill EMC requirements when they are outside as well
50. isual T see Fig 4 2 connectors in see Fig 4 2 Bl 9 E auxiliary power outlets see Fig 4 4 power supply socket see Fig 4 3 Figure 4 1 The system 5 rear panel 72 Chapter 4 February 2014 Pro Focus 2202 User Guide BB1247 V CD writer in monitor base audio out system monitor color video o internal use printer recorder es monitor base out composite color video color video rinter or printer recorder ea out S VHS video voa not available B W video rinter out c documentation trigger connectors LAN DICOM video camera video recorder in Composite USB printer RGBS source B W or color e g camera video camera foot switch video recorder in 3 pedals S VHS audio in not in use not in use foot switch 2 pedals Figure 4 2 The peripheral connectors on the rear of the system Bold arrows indicate connections installed at the factory Do not change these connections Cables Types and Lengths Table 4 2 specifies the cables that were used to test the electromagnetic compatibility EMC of the system EMC data for all transducers used with this system are in the Technical Data BZ2100 section on the CD that accompanies this user guide The CD also contains a list of accessories used in testing for EMC compliance To fulfill EMC requirements do not attach cables to the system unless they are the same type as listed in the table and do not exceed the maximum length
51. j 11 1 DD 1 Video PIP Mi 1 00 lt 1 50 E ae ne Tae a Soe P A ae E pa TIS 1 0 lt 2 0 J l l _ LR UD Res Hz 2 25 Hz Click here to select a different Customize Save matrix or puncture guide Autofocus Gain 50 sil A O E ES _ Light O Timer Dyn Range 79 dB A A E A O ae B Color Harmonic Off Angle Baraat 6 4 Edge 2 Line Density 2 a Multibeam 1 j A Noise Reject D Height Width eS Length Ellipse Planimetry Freehand ak es A B E D E E G el PSAD i 0 4 cm Burn CD USB Eject p gt View Exam View Archive es Figure 2 10 A matrix on the image area To select a different puncture guide or matrix 1 Click the Type number or matrix name displayed at the top of the image area The Puncture Guide menu appears It contains the puncture guides and matrices that are available for the selected transducer Brachy 10mm Brachy Smm Prog 1 13 4 6 10mm Prog 1 13 4 Smm Prog 1 2 4 6 10mm Prog 1 7 4 6 5mm 1181232 5mm Figure 2 11 The Puncture Guide menu 2 Click the puncture guide or matrix you want February 2014 Pro Focus 2202 User Guide BB1247 V The menu disappears and the markings on the image area are updated To remove the puncture line or matrix from the monitor e Press Bl Programmable Puncture Guide If you are using a programmable puncture guide you can change the setup to move it to the left or right or in or out
52. k vs logo the stronger the signal strong signal When the system is not connected to a wireless network the Wi Fi logo has a red x over it No wireless connection 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 Pro Focus 2202 User Guide BB1247 V General and Safety Information 23 Additional Characteristics Security characteristics Support for WEP WPA and WPA2 encryption Enterprise encryption 802 1x 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 training requirements warning on page 25 NOTE The system only supports one network at a time If the system loses connection with the network while transmitting for example because it is moved out of range of the network during a transmission the pending data is stored temporarily and re transmitted when the connection 1s re established For info
53. learance by the FDA are well defined Track 3 is for diagnostic ultrasound systems that follow the Output Display Standard 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 Pro Focus 2202 Ultrasound System are Track 3 Monitor Display The Mechanical Index MI and Thermal Index TI can be viewed in all imaging modes Pro Focus 2202 User Guide BB1247 V General and Safety Information 25 Thermal and Mechanical Indices Blood perfusion and 26 Chapter 1 Tl Fever 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 3 and 10 but the formulas are given below MI Formula Pal df where the variables are defined in the table below MI Variable Definition the point on the beam axis where pulse intensity integral Pllp 3 is maximum fe measured center frequency in MHz TI Formula W Tiet deg where the variables are defined in the table below Variable Definition W time averaged acoustic power of the source or other power parameter W Wieg estim
54. lowing two conditions 1 This device may not cause harmful interference and February 2014 Pro Focus 2202 User Guide BB1247 V 2 This device must accept any interference received including interference that may cause undesired operation Other Safety Considerations A Mechanical injury A Polygon measuring tool A Using Doppler curves A Nuchal translucency A Artifacts Pro Focus 2202 User Guide BB1247 V Mechanical failure or unintended use of ultrasound equipment can result in physical Injury to patients or operators WARNING Be careful to avoid the following potential sources of injury e Parts of the body can be pinched by moveable parts of the system such as the keyboard panel and the monitor e Tilting the system can cause it to be unstable and injure someone e Donotlean or sit on the keyboard or any other part of the system The keyboard panel or monitor can break if subjected to heavy weights or impact Measurements Pay careful attention when you position cursors to make measurements on an image or on a Doppler curve WARNING 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 Drawings of Doppler curves manual and automatic are meant as tools f
55. m s isolated auxiliary power outlets see below if it does not comply with EN IEC 60601 1 2 In particular if you connect an IEC 60950 apparatus such as a PC it must be outside the patient area and get its power from the system Auxiliary Power Outlets To minimize leakage currents plug all other equipment into the isolated auxiliary power outlets on the bottom right of the rear panel There are 4 auxiliary outlets as shown in Fig 4 4 Caution The 4 auxiliary power outlets are still live even when the standby switch on the front is turned off In order to remove voltage from these outlets you must unplug the power supply cord from the wall outlet AUX as mains potential Total max 350VA protective equalization Four Isolated AUX ground terminal terminal Figure 4 4 Auxiliary power outlets The voltage and frequency of these outlets is the same as from the power supply cord The thermal fuses limit the power that can be drawn from the outlets to a safe level but the available total output from the auxiliary outlets must not exceed 80 VA 1f the black and white printer EQ4071 is attached to the system Actually the total output is limited to 350 VA but the system monitor using 150 VA is permanently plugged into one of the outlets and the USB black and white printer uses 120 VA This leaves 80 VA for other accessories Additional Protective Ground An additional protective ground can be connected to the L ter
56. ment 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 01s e accuracy 0 01 xt where is the full time scale of the image field Doppler Measurements References 30 Chapter 1 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 O between the ultrasound beam and the velocity vector of the blood cells The velocity accuracies given in Technical Data BZ2100 are valid for 0 55 To find the percentage accuracy for other angles multiply the stated accuracy by soso cos 0 1 8 x 100 0 5 cos If the blood velocity exceeds the selected velocity range aliasing occurs corresponding to an overload condition of the measurement system 1 EN 60529 1991 A1 2000 Specification for degrees of protection provided by enclosures IP code 2 EN TEC 60601 1 1990 A1 1993 A2 1995 A13 1996 Medical electrical equipment Part 1 General requirements for safety EN IEC 60601 1 2006 3rd Ed Medical electrical equipment Part 1 General requirements for basic safety and essential performance 3 EN 60601 2 37
57. minal below the auxiliary power outlets see Fig 4 4 1 HistoScanning is not market cleared by the FDA for sale in the USA and not licensed by Health Canada February 2014 Pro Focus 2202 User Guide BB1247 V Potential Equalization by The potential equalization terminal b below the auxiliary power outlets see Fig 4 4 is connected to the system chassis It can be connected to corresponding terminals on other equipment to eliminate potential differences Dismantling the System for Transportation The keyboard panel keyboard base monitor and monitor base can be removed to make it easier to transport the system release handles screws ei a Figure 4 5 Removing the keyboard base en monitor base sliding covers n keyboard panel keyboard base Keyboard Base and Panel To remove the keyboard base and panel N AQ uu Bf WN Move the keyboard base to the top position Unplug the keyboard panel from the front of the system Lift and remove the keyboard panel see Fig 4 5 Remove the 2 sliding covers from the system Loosen the black screws under each side of the keyboard base Press the black release handles and lift the keyboard base out of the groove Replace the sliding covers To replace the keyboard base and panel 1 UN bb W N Remove the 2 sliding covers from the system Slide the keyboard base back into the grooves Tighten the black screws Reconnect the keyboard panel to t
58. n Table 3 11 Function of the Miscellaneous Control keys 62 Chapter 3 February 2014 Pro Focus 2202 User Guide BB1247 V TGC Sliders The 8 TGC sliders to the upper right of the keyboard are used to adjust the Time Gain Control at various depths in the image TGC sliders PAANAN OAA n ed de la o e a Es a mp Se O tl e _ Figure 3 13 The T GC sliders on the keyboard nal Each slider controls 1 8th of the depth of the displayed imaged area The top slider affects the top of the image and the bottom slider the bottom With 360 transducers the top slider adjusts the part of the image that is most central that 1s closest to the transducer The bottom slider adjusts the part of the image farthest from the transducer Move the sliders to the right to increase gain Move the sliders to the left to decrease gain Each slider is related to a part of the monitor rather than a part of the tissue being imaged Therefore if you move resize or invert the image area you may have to use the sliders to readjust the TGC in order to get the best image Keyboard In addition to the control keys the keyboard panel contains an alphanumeric keyboard for entering information into the system The F1 to F1 o keys are user definable keys The Fs and F1 o keys have default functions assigned F8andF10 Key Name Default Function F8 F8 Displays a report A report is defined for each Pro Package The
59. n exam and then resume it later To pause an exam 1 Start an exam Capture some images This is not essential 2 Inthe Archive window click Pause Continue Examination To resume a paused exam 1 Inthe Archive window select a paused examination from the list 2 Click Pause Continue Examination To pause an exam and simultaneously resume one that was previously paused Start an exam Capture some images This is not essential In the Archive window select the paused examination you wish to resume Click Pause Continue Examination A WN The current exam is paused and the selected one is resumed 42 Chapter 2 February 2014 Pro Focus 2202 User Guide BB1247 V Discontinue Examination with MPPS Server Configured If an MPPS server is configured you can discontinue the current examination Click Discontinue Examination to end the examination the system will send a DISCONTINUE message back to the MPPS server You will be prompted to confirm that the examination must be discontinued Discontinuing the examination clears the current patient data and closes the Patient Window Discontinued examinations can be retrieved from the Patient List for later completion see the Documentation chapter in the Extended User Guide for more details The 2202 Service Manual B12201 contains instructions for service personnel to use when configuring a MPPS server If you try to start or resume examinations on patients with discontinued exami
60. n your system Keyboard Panel Controls The Pro Focus keyboard panel contains e an alphanumeric keyboard e acontrol panel with special system control keys Pro Focus 2202 User Guide BB1247 V The User Interface Keyboard k k k k h kh k UJ Control panel Figure 3 1 The keyboard panel The Control Panel Each control key has a backlighted label that is visible when the functionality of the key is available Keys turn green to indicate an active function There are several types of control keys categorized according to how you use them 52 Chapter 3 February 2014 Pro Focus 2202 User Guide BB1247 V Key types Key Type Example Action Trackball Rolling the trackball moves a cursor on the monitor Pressing the key adjusts a value or moves a cursor Stepwise up or down pressing the side increases the value pressing the side decreases it A long press repeats the action Pressing the key activates a function or turns something on or off Sometimes a long press at least one second is required to turn it off Press Dial Turning adjusts the gain Turn clockwise to increase the gain turn counterclockwise to decrease the gain Same as for the key the side being closest to the trackball the side furthest away from the trackball Rocker Slider Moving the slider adjusts a value continuously Table 3 1 Control key types Press long In some situations press
61. nMenl 1246 a44icws edad de 71 The Rear OL Ne System dre LA bbs 71 Cables Types and Lon its aia ao 73 MONIO ura rra dar loa dad 74 Audio Input and Output o ooooooocoorooooromorrrmooo o 74 Documentation Accessories oooooooocooooomoronrromno oso 75 Foot Switch Connector o 76 Electrical CONNSCUONS 4 5 0 o4 5 2ues4 ad nasa dara 76 POWErSUDDIY CON oan cdi eee ee oad vole oes ee es 76 Connecting Other Equipment 0 00 eee nes T Dismantling the System for Transportation 0 0 00sec eee eee eee 79 Keyboard Base and Paneles o aia 79 MOI a e Be ae ae 80 Noto Base 46 25 6 4 eae criar nd dad 80 ESO SCANNING DAA bee eae Bale Eee het 81 Using the System with a Lithotriptor oooooooooooooomoooo o 82 iS E NC C5 eE N A 82 Appendix 1 Specifications and Indications for Use cscsccececccccececececececsceess 83 Indications tor Us ea 5 5 eaters as ho Eb ede outlet Ae he Ee Rae a ets 83 CONTAMOS sts ot and ead So HS Pe eR a 83 English source version BB1247 V Chapter 1 General and Safety Information This guide is an abridged version of the Extended User Guide It contains basic information about the Pro Focus 2202 Ultrasound System in the following referred to as the Pro Focus from BK Medical e safety information e turning on the system and getting started e the user interface e technical guide what to connect where Intendeduse The system is a 2D and 3D ultrasound echo and flow ima
62. nations you will be prompted to choose between these options e Continue the existing examination e Delete existing examination and start a new e Cancel Ending an Examination An examination is automatically ended 1f you start a new one To end an examination without starting a new one e Press long 2 ID Connecting and Selecting Transducers Connecting a Transducer On the front of the system body are 3 sockets for connecting array transducers There can be a socket for connecting mechanical transducers Keep cables Under the keyboard panel are a number of hooks that can help keep transducer cables tidy tidy and out of the way See Fig 2 1 Pro Focus 2202 User Guide BB1247 V Getting Started socket for SOT mechanical M E P transducer o p optional 3D mover socket optional sockets for array ECG optional Figure 2 7 The transducer sockets To connect a transducer 1 Insert the transducer plug into the socket 2 Turn the locking lever on the transducer plug clockwise To disconnect a transducer 1 Turn the locking lever on the plug counterclockwise 2 Remove the plug from the socket Transducer Holders The 4 transducer holders beside the keyboard panel keep the transducers you need safe and ready for use Transducer holder inserts DZ9756 are available to hold the smaller transducers in the BK Medical range See the 2202 Product Data sheet for a list of accessories that can be orde
63. nd enter some information about the patient including the patient ID The fields in the Patient window contain information about the patient and the examination AN WARNING You must enter a new patient ID before you scan 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 Patient ID required A N WARNING Verify that the patient name and ID are correct Verify patient ID Pro Focus 2202 User Guide BB1247 V Getting Started 37 Opening the Patient Window Opening the Patient window Change the Pro Package 38 Chapter 2 first Auto complete There are 3 ways to open the Patient window To open the Patient window e Press cn ID or e Click Enter Patient or the name of the previous patient in the identification area on the monitor or e Click New Examination in the Archive window The Patient window opens Last Setup Prostate 8 1 Patient ID _ Keep image settings Figure 2 5 The Patient window Some fields in the Patient window are different depending on which Pro Package is selected Therefore if you want to change the Pro Package make sure you do it before you enter information about the patient See the next section for how to do this If DICOM is installed on your system the Patient window may contain a worklist as in F
64. nistration 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 microsoft com exporting e The Pro Focus 2202 Ultrasound Scanner 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 from B K 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 Pro Focus 2202 system Trademarks DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information Microsoft and Windows are registered trademarks of Microsoft Corporation in the United States and other countries SonoVue is a registered trademark of Bracco S p A DEFINITY 1s a registered trademark of Bristol Myers Squibb Medical Imaging FireWire is a trademark of Apple Computer Inc CIV Flex is a trademark of CIVCO Medical Instruments Co Inc 2014 BK Medical Information in this document may be subject to change without notice Contents Chapter 1 Chapter 2 General and Safety Information ooooooomommomocosorsssssssssososo 7 Wiser Documentation o AA 7 Date I
65. o move a cursor or graphical control When an on screen It is You can control has the color White Available Point at it or select it Orange Pointed at Adjust it with Select it Blue Selected Move it with the trackball Adjust it with the pointer or Gray Unavailable No action possible Table 3 13 Color coding of controls on the monitor For some actions you do not need to click You can just point and press the key see the following section Moving To move a graphical control on the monitor 1 Click the control to select it 2 Drag the selected control to the position you want 3 Click to release the trackball for other uses Changing To resize a graphical control on the monitor size e Select or point at the control and press or 1 Click a boundary of the control such as a corner of a box or a boundary of the focus indicator to select it Drag the selected control part until the control is the size you want 3 Click to release the trackball for other uses Pro Focus 2202 User Guide BB1247 V The User Interface 65 Softkeys The monitor contains many softkeys for functions whose value can be adjusted or changed These softkeys appear as words or abbreviations on the monitor Softkeys with To select a value for a softkey values 4 Click the softkey A list of possible values appears 2 Click the value you want You can also use to scroll up and down in the list and then p
66. occur that requires technical support you press standby Never unplug the system from the wall without turning off the standby switch and waiting switch for its light to go out Waitto If you turn off the system without following the recommended procedure for example if unplug you unplug it while it is running the next time you turn the system on it may take a longer time to start and the system may be permanently damaged System Busy When the system 1s busy that is performing an operation that takes some time a spinning disk appears above the Freeze control on the monitor AN Caution Wait until the spinning disk disappears before you press any keys on the system or buttons on the transducer Checking the Date Check that the date and time displayed on the monitor are correct before you start imaging a new patient or at least at the beginning of each day AN WARNING An incorrect date or time will make documentation of the image incorrect and may also cause some calculated values to be incorrect Pro Focus 2202 User Guide BB1247 V Getting Started 35 One cause of an incorrect date is battery failure The battery fails very rarely If it does fail the system will usually not operate at all so you will know to call a technician However under certain unusual circumstances the system will operate but the date will be incorrectly set to a default date Settings on the Monitor Instructions for the monitor vary depending
67. on screen controls see Controls on the Monitor on page 64 Basic Keys The Basic keys are arranged around the o keys for easy access These keys work in different imaging modes For detailed information about using them see the Pro Focus 2202 Extended User Guide BB 1279 Basic keys Figure 3 4 The Basic keys on the control panel Basickeys Key Name KeyType Action Please note that some of the documentation functions are only available after a patient ID has been entered Table 3 3 Function of the Basic keys on the control panel Pro Focus 2202 User Guide BB1247 V The User Interface 55 B Mode Keys The B mode keys are centered above the trackball For detailed information about using them see the Pro Focus 2202 Extended User Guide BB1279 B mode keys Figure 3 5 The B mode keys on the control panel B mode keys Key Name Key Type Action Gain 8 Ed 8 Table 3 4 Function of the B mode keys on the control panel B Mode Adjustment Keys The B Mode Adjustment keys are grouped on the right side of the control panel For detailed information about using them see the Pro Focus 2202 Extended User Guide BB1279 56 Chapter 3 February 2014 Pro Focus 2202 User Guide BB1247 V B mode Adjustment keys Figure 3 6 The B mode Adjustment keys on the control panel B mode Key Name Key Type Action Adjustment T i Dyn Range Resolution Width D Frequency
68. on whether your system 1s fitted with an LCD flat screen monitor or an LCD flat screen monitor mounted on the articulating arm Brightness On 19 LCD monitor On 17 LCD 36 Chapter 2 monitor Your system may be used with different levels of room lighting Whenever the lighting changes significantly you should adjust the monitor brightness NOTE Do not press the button on the 19 LCD flat screen monitor or the Q p button on the 17 LCD flat screen monitor These activate the contrast menu The contrast settings should only be adjusted by the hospital technician or by your BK Medical service representative Do not press this AUTO MENU POWER On Off Figure 2 3 19 flat screen monitor buttons To adjust the monitor brightness on the 19 LCD flat screen monitor 1 Freeze the image 2 Press Alt Shift G on the keyboard A series of gray bars appears on a black background 3 Press once to enable brightness Then press to increase or press to decrease brightness Subsequent presses either increase or decrease the brightness Do not press this On Off Figure 2 4 17 flat screen monitor buttons To adjust the monitor brightness on the 17 LCD flat screen monitor 1 Freeze the image 2 Press Alt Shift G on the keyboard A series of gray bars appears on a black background 3 Press 44 once to enable brightness February 2014 Pro Focus 2202 User Guide BB1247 V
69. or positioning cursors so that measurements based on the curves can be calculated automatically The system has no facilities for checking whether the automatic measurements are reasonable Curves drawn on very noisy spectra may lead to misplacement of measurement cursors 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 Caution You must be adequately trained before you attempt to make nuchal translucency measurements Vector Flow Imaging WARNING 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 1 VFI is not licensed by Health Canada General and Safety Information 17 A Arrow aliasing A Diameter markers ZN Doppler gate large enough A Doppler gate over only one vessel A Doppler spectrum aliasing A A Untracked freehand 18 Chapter 1 WARNING 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
70. parameters It has a measurement section at the bottom The measurement section displays the results of current measurements you have made e The Image area the Identification area and the Data area make up the Image Documentation area and will appear in documentation except for the Pro Package and preset names e The Image and Measurement area is to the right You may need to click Image to see the image tools or click Measurements to see the measurement tools This area will not appear in documentation February 2014 Pro Focus 2202 User Guide BB1247 V Browserarea e The Browser area is at the bottom Small pictures thumbnails of the clips and Images stored in the system are displayed across the bottom of the monitor This area will not appear in documentation Point and Click Using the trackball and trackball keys to interact with the controls on the monitor 1s Intuitive and easy In this user guide certain terms are used consistently to tell you what to do Terminology Pointat Use the trackball to move the pointer to a control When a control is pointed at you can adjust it with the key but you cannot move it To move a graphical control you must select it Click select Point at an on screen control and press When a control is selected moving the trackball resizes or moves it Pressing again cancels the selection making it possible to use the trackball to move the pointer Drag Use the trackball t
71. r network DICOM that has not been isolated If the network is not isolated the system must be connected via a network isolator DP0925 see Accessories in Product Data sheet AN WARNING Equipment that complies with the requirements of EN IEC 60601 1 2 UL 60601 1 4 or CSA C22 2 No 601 1 M90 5 can be connected to the system but the power for the equipment must come from the auxiliary power output on the system or from an independent wall power outlet You can use the isolated auxiliary power outlets on the system to connect equipment such as a monitor or video printer requiring a total of 350VA or less Otherwise you can plug the system and other equipment into an external common isolation transformer in order to control the leakage current during a ground connection fault Follow the guidelines in EN60601 1 1 7 If in doubt contact your local BK Medical representative Medical equipment YN WARNING If you connect non medical equipment instruments that do not comply with safety requirements for medical equipment this equipment must be placed outside the Non medical patient environment 1 5m from the bed for example The equipment must fulfill the ios relevant EN standard or other applicable national or international standard ocation standards The power for the equipment must come from the auxiliary power output on the system and power You can use the isolated auxiliary power outlets on the system to connect equipment such s
72. r on monitor EXAM 3 system hard disk or print it User definable Select T H Start Stop imaging Adjust value or size of zoom box etc Holding down the key repeats the action al J i Adjust gain for one mode only PRF If Color On but not Q the first in this list that is active Doppler adjust Color PRF Doppler Color Power B mode Toggle imaging modes Start a default measurement B gt Color gt Doppler gt B xx B gt C gt D User definable User definable User defined gh AUTO Optimize image and Doppler settings Hold down P and AUTO for three seconds when pairing with the system BK Medical Figure 3 15 The remote control with the location of its various controls The remote control uses short wave radio waves to communicate with the system Pairing the Remote Control with the System 1 Plug the Mini Bluetooth Adapter into a USB connector on the system Use the one that came with the remote control 2 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 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 Pro Focus 2202
73. red to use with the system Gel Holders The two gel holders behind the transducer holders hold gel containers ready for use Selecting a Transducer You can choose to image with any of the transducers that are connected to the system The type number of the transducer currently selected is displayed together with the imaging frequency in the Identification area at the top of the monitor See page 64 YN WARNING Before you start to image make sure that the type number of the transducer you have selected matches the number displayed on the monitor If they do not match Type the puncture line on the monitor may not correspond to the true puncture path in the number tissue In case of any inconsistency stop imaging turn off the system and contact your displayed local BK Medical representative must match number on transducer 44 Chapter 2 February 2014 Pro Focus 2202 User Guide BB1247 V To select a different transducer that can be used with the same Pro Package e Point at the transducer type number on the monitor and press to select the transducer you want or e Press the button on the transducer itself if it has a button To change Pro Package as well as transducer or to see all connected transducers and the Pro Packages that support them see Selecting a Pro Package or Preset on page 46 Selecting the Imaging Plane If you are using a transducer with more than one plane you can select the imaging plan
74. ress NOTE Not all softkeys may be visible Click the expand menu symbol E to see all items in a menu To change the setup for how menus appear see Pro Focus 2202 Extended User Guide BB1279 Slider Some softkeys have a slider that you move with the trackball softkeys On Off Some softkeys have only two values On and Off softkeys To change the setting of an On Off softkey e Click it or e Point at it and press to toggle the value Small green A small green light next to the key indicates that it is set to On light Foot Switch The optional foot switch has 2 or 3 pedals You can assign a function to each pedal and the same pedal can have different functions for different Pro Packages For information about assigning functions to the pedals see Pro Focus 2202 Extended User Guide BB1279 To use the foot switch e Press the appropriate pedal NOTE Releasing the pedal does not operate or reverse the function Remote Control The wireless remote control UA1237 is an option available for the Pro Focus UltraView It uses short wave radio waves to communicate with the system and control many of its functions 66 Chapter 3 February 2014 Pro Focus 2202 User Guide BB1247 V The Remote Control and Its Functions Blue diode Blinks to show _E o o Battery level Blinks to warn that remote control is awake batteries must be replaced soon Change exam type list Capture an image to the will appea
75. rmation on saving and printing using the DICOM protocol see the Documentation chapter in Pro Focus 2202 Extended User Guide BB1279 AN 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 AN 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 Acoustic Output General Medical research has yet to prove whether or not ultrasound causes biological effects Therefore prudent use considerations require you to follow certain guidelines 3 Prudent Use JN WARNING Always keep the exposure level the acoustic output level and the exposure time as low as possible Exposure level 24 Chapter 1 February 2014 Pro Focus 2202 User Guide BB1247 V 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 26 and increase the level only as much as necessary to obtain a satisfactory image e If you switch from an application requiring high acoustic output levels see Functions Affecting Acoustic Output on page 27 to one that requires lower levels fetal imaging for example be sure to rese
76. rs connect the video recorder output to the connectors 74 Chapter 4 February 2014 Pro Focus 2202 User Guide BB1247 V Documentation Accessories The optional digital B W printer EQ 4100 which should be connected to the de port A If you install other documentation accessories always follow the installation and verification instructions in the user guide that accompanies them See Connecting Other Equipment on page 20 Always use the cables specified in the 2202 Product Data sheet PAL NTSC The format for the video output that is sent to a video printer or video recorder can be either PAL or NTSC To set the format for video output from the system 1 Make sure that the PAL NTSC switch on the rear of the printer is set to the appropriate format 2 Open the General Setup window 3 Select the video output setting you want and close the window Video Documentation Equipment Table 4 3 gives an overview of video documentation connections See also Table 4 2 Equipment Signal type Connector Comments Video printer B W Composite Out Video printer Color RGBS Out gt RGBS The R G and B signal levels are 0 7Vpp 75Q The S Sync signal level is TTL Video printer Color Composite Out te Video recorder Composite Out te Video recorder Composite In E en For playback Video recorder S VHS Out Video recorder S VHS In For playback Video monitor B W Composite Out C Video monitor Color RGBS
77. rtable 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 50 MHz 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 Radio Interference emission requirements 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 Installation A WARNING To ensure safe performance a qualified electrical engineer or hospital safety personnel must verify thatthe ultrasound system is correctly installed and that it complies psss with the safety requirements described below ea E e Use only the original power supply cord This must be fitted with a hospital approved MENT three prong grounded power plug See Power Supply Cord on page 76 e Use only the original monitor power cord to connect the monitor to the system e The equ
78. set o oooooooooomo ooo 46 Savine a A arceriouaua dk Say Aad d aa ee oe nee 46 Selecting or Changing the Imaging Mode 0 0 eee 47 Performing a Biopsy or Puncture Procedure including Brachytherapy 47 REMOS CONTO tas ara aa 50 Cleaning and Disinfection tas rs 58 OL Ean e 50 Ine User INTENT aCe init 51 Keyboard Panel Control sais ds 5I Phe Cont Ol Panel peeraa bebida aa hbo 52 The Trackball and Trackball KeyS oooooooooooo o 53 A ING OAc ia tisk ea A nee a Ae ee 55 Pe EOC LA A eee aA 56 B Mode Adjustment Keys voii irracional 56 Power and Color Mode Keys irc Awning 544388448 2 CRA WEES 58 Doppler and M Mode KEYS cir A a tie kes 58 Doppler ustinent Keys cres idad adds 59 User DEE UIT aaa A a EE E 60 mass Anota HOR KO Sa Ed EAS 61 Miscellaneous Key escaner e sean hehe eag Meee ee 62 TGC SHOCKS ad iaa 63 A 5 64 Ach eo See os he ees ae CARE a eee 63 Controls On the Montoto sida das cog at a es 64 RA AAA Ree eee a as 65 POOL A ard oer Se aie Cis ae eek a Be SA Rete aeweieaten 44 66 Remote Controla os Ed AE wee eae GA 66 The Remote Control and Its Functi0DS o o ooooooooooooooo 67 Pairing the Remote Control with the SysteM o o oooooooo 67 IESO sad dra 68 MOUSE FUNCION di A eee 68 Replacing Bates cai y taa 68 Cleanine and Dismiecuo asada ii 68 SANS CUCCIS A A oe ee ee cde oh 69 Chapter 4 Technical GUIAS tii dada dada ia 71 Operatino PaVirO
79. setup You can prevent this from happening see Keeping Image Settings on page 41 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 28 Chapter 1 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 Technical Data BZ2100 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 measurements 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 spec
80. splayed image area In order 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 For brachytherapy and prostate transperineal biopsy make sure that the matrix type and coordinates indicated on the monitor agree with the actual matrix template you are using WARNING Before you use the matrix for seed implantation or transperineal biopsy check the matrix offset value to verify that it corresponds with the chosen matrix Then check the matrix alignment See Care Cleaning amp Safety Getting Started 47 Activate guide or matrix Set default 48 Chapter 2 To superimpose a puncture line or matrix on an ultrasound image e Press Bl The default puncture guide or matrix appears To set a different puncture line or matrix to be the default e After you have selected the puncture line or matrix you want and made any other setup changes you want save your settings as a new preset see page 46 Specify that you want the new setup to be your default To highlight the dot on a matrix where you expect to see the needle e Click one of the dots on the matrix A blue square appears in its place e To highlight a different dot click it The previously highlighted dot returns to normal and the new one 1s highlighted ray B K Medical 18 01 2007 8658T Pro Urology A Enter Patient A ar Setup Prostate 6 5 EHAA poa w e e eame ros Seon
81. sure that the power supply cord cannot be accidentally disconnected from the system The kit consists of two mounting screws and two brackets each fitting a different type of power plug To use the cord retainer lift the bracket up when you plug in the power supply cord Then push it down over the plug so it holds the cord Connecting Other Equipment For important information about connecting other equipment safely see Connecting Other Equipment on page 20 Lithotriptor Special considerations apply if you are using a lithotriptor with the system See Using the System with a Lithotriptor on page 82 AN WARNING When you connect other equipment that uses the line voltage such as a video l printer video recorder endoscopic camera control unit or other documentation device to Equipment thesystem the connections must follow the guidelines given in EN 60601 1 1 1 If in that Ba doubt contact your local BK Medical representative voltage Pro Focus 2202 User Guide BB1247 V Technical Guide 77 A Power isolation requirement S A Standby switch does not turn off 78 Chapter 4 outlets Using the RS 232 and LAN Connectors You can connect other equipment to the RS232 and LAN connectors on the back of the system see Fig 4 2 You can connect a HistoScanning workstation to the LAN connector WARNING Electrical equipment that is connected to the RS232 and LAN connectors must get its power from the syste
82. t keys Scale 1 Rocker Baseline Rocker Filter O Rocker Sound a Rocker Steer S Rocker Angle Rocker 4 On Press Inverse Press Table 3 8 Function of the Doppler Adjustment keys on the control panel User Defined Keys The user defined keys are placed on the right side of the trackball By default the P1 key is set up to open the Calculations menu and the P2 key is set up to open the Measurements menu 60 Chapter 3 February 2014 Pro Focus 2202 User Guide BB1247 V User defined keys Figure 3 10 The user defined keys on the control panel User defined Key Name Key Type Action keys Table 3 9 Function of the user defined keys on the control panel Image Annotation Keys The Image Annotation keys are grouped on the top right side of the control panel For detailed information about using them see the Pro Focus 2202 Extended User Guide BB1279 Image Annotation keys Figure 3 11 The Image Annotation keys on the control panel Pro Focus 2202 User Guide BB1247 V The User Interface 61 Image Key Name Key Type Action Annotation keys 5 00 E 5 Table 3 10 Function of the Image Annotation keys on the control panel Miscellaneous Keys The keys on the top left side of the control panel have varied functions Miscellaneous keys Figure 3 12 The Miscellaneous keys on the control panel Miscella neous keys Key Name Key Type Actio
83. t 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 YN WARNING Before you attempt to use BK Medical equipment you should be trained in hes ultrasonography or be under the supervision of someone who is trained in Training ultrasonography You should also be thoroughly familiar with the safe operation of your require ultrasound system read all the user documentation that accompanies it Always use the ments transducer best suited to the examination 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 Acoustic output data for transducers used with the system are given in Technical Data BZ2100 The uncertainty level for each parameter 1s also listed For definitions of the parameters refer to the Food and Drug Administration FDA Guide 8 as well as EN 60601 2 37 3 and AIUM NEMA standards 9 10 In North America the FDA requires all ultrasound equipment to be cleared before it is marketed in the United States The routes or tracks available for c
84. tains the patient Now that patient is shown in the fields below the worklist If required enter additional information in the fields in the window 3 Press OK to start the examination February 2014 Pro Focus 2202 User Guide BB1247 V Entering Dates The Patient window contains one or more date fields Dates in these fields can be displayed in various formats Format Example dd MM yyyy 18 11 1944 dd MMM yyyy 18 Nov 1944 MM dd yyyy 11 18 1944 MMM dd yyyy Nov 18 1944 Table 2 1 Possible date formats The date format 1s set up in the General Setup window but you probably will not need to change it Use number Use the number keys on the keyboard to enter dates keys NOTE You cannot type letters in a date field even when the month is displayed in letters In the example in Table 2 1 you must type 11 for the month even if it is displayed as Nov To enter dates in date fields 1 Put the cursor at the beginning of the date field 2 Type the date or number of the month 1f your system 1s set to display month first 3 Type a separator or press gt to move to the next part of the date You can use any of the following separators period comma hyphen and slash The separator you use when you enter a date does not affect the way the date is displayed in the field Type the appropriate number 5 Repeat steps 3 and 4 Keeping Image Settings When you enter a new patient ID the transducer setup
85. ture attachments Product Data for each transducer Specifications for the transducer including disinfection methods that can be used Table 1 1 User information documentation that accompanies the equipment Pro Focus 2202 User Guide BB1247 V General and Safety Information Improperuse Failure to follow safety instructions or use for purposes other than those described in the user guides constitutes improper use 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 You must also follow local government rules and guidelines at all times Important safety information is indicated in the user guide by means of special formatting YN WARNING Warnings contain information that is important for avoiding personal injury AN Caution Cautions contain information and instructions that must be followed to avoid damaging equipment data or software NOTE Votes contain information that you should be aware of Typographical Conventions The following typographical conventions are used in this manual FREEZE a function something you can do by using the keyboard panel or the graphical user interface on the monitor Freq text that can be selected or clicked on the monitor Power a key on the keyboard panel Book Titles names of books and scientific journals 1 References Literature references are foun
86. upply asa monitor or video printer requiring a total of 350VA or less Otherwise you can plug the system and other equipment into an external common isolation transformer in order to control the leakage current during a ground connection fault Follow the guidelines in EN60601 1 1 7 If in doubt contact your local BK Medical representative 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 20 Chapter 1 February 2014 Pro Focus 2202 User Guide BB1247 V For detailed information about e network requirements e network configuration e workflow between devices e technical specifications e safety specifications see BK Medical 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 patient ID warning on page 37 e System is unable to use the network du
87. using The Pro Package and preset currently selected are displayed in the Identification area of the monitor See page 64 To select a Pro Package or preset 1 Press 5 or click the Pro Package or preset displayed in the identification area of the monitor The Pro Package Menu window appears It contains a column for each connected transducer The column lists the Pro Packages and presets that you can use with that transducer Full Table Pro Package Only 5805 8801 Fr 8 0 12 0 MHz _ 2 9 5 0 MHz Breast Abd pen Musculoskeletal Abd persist Periph rtery Abd res Periph Yein Bladder Y Small Part Kidney General SonoYue a F urology M Testis E ar Fetal Heart Gynecology OB Gn OB contrast OB pen OB res Close Figure 2 8 The Pro Package Menu window 2 Select the Pro Package and preset you want 3 Click Close Saving a Preset When you have changed the setup you can save it as a new preset To save a preset 1 Click Save under Image on the right side of the monitor The Save Preset window appears Save Preset 44 y Make Default Figure 2 9 The Save Preset window 46 Chapter 2 February 2014 Pro Focus 2202 User Guide BB1247 V 2 Enter a name for the preset and select the options you want for example whether you want the setup to be the default for the transducer with the current Pro Package Puncture guide or brachy matrix settings will be saved as part of the setup
88. ustic 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 Pro Focus 2202 User Guide BB1247 V General and Safety Information 27 The user can set a Thermal Index limit This will provide an upper limit for acoustic output Default Acoustic Output Fetal imaging 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 transducer are listed in 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 1s part of the ALARA principle The factory default setup for all transducers 1s B Mode to ensure the lowest acoustic output when you start imaging When you enter a new patient ID the transducer setup will be reset to the default
89. well as important information about attaching other equipment and so on Before you turn on the system make sure that the installation has been approved by a qualified service technician or by hospital safety personnel See Safety Precautions in Chapter 1 General and Safety Information Operating Environment A A The Pro Focus can be operated safely within the following operating condition limits Condition Limits Ambient operating temperature 10 C to 40 C 50 F to 104 F Humidity max 85 RH non condensing Atmospheric pressure between 700 hPa and 1060 hPa Table 4 1 Operating condition limits WARNING Follow the guidelines in EN60601 1 1 1 when you connect the system to other equipment See General Safety Precautions on page 12 WARNING During use the system must be at least 25 cm 10in from the patient to minimize the risk of igniting explosive gases Explosion hazard The system is not intended for use in potentially explosive environments and should be kept well away from flammable gases and liquids It should not be used in oxygen enriched atmospheres Avoid excessive heat dust and direct sunlight The Rear of the System The rear of the system body see Fig 4 1 and Fig 4 2 contains a large number of connectors for connecting different equipment Pro Focus 2202 User Guide BB1247 V Technical Guide 71 audiovisual connectors out pl see Fig 4 2 ai F UY EE auxiliary connectors audiov
90. ystem make sure that all the safety requirements described in this chapter have been satisfied Explosion Hazards A WARNING The ultrasound system is not designed to be used in potentially explosive environments It should not be operated in the presence of flammable liquids or gases or Explosion in oxygen enriched atmospheres hazards There is a possible explosion hazard if the system 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 A Do not use a power strip A Leakage current A Electrical shock WARNING Do not plug the system into an ordinary power strip If the ground connection fails this is dangerous because e the total leakage current for all the connected equipment can exceed the limits specified in EN IEC 60601 1 2 e theimpedance of the ground connection will probably also exceed the limits specified in EN IEC 60601 1 WARNING 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

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