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39

Index

Numerics

3D

warning about untracked freehand and measure-

ments 29

A

accuracy

2D geometric measurements 34
3D distance 34
3D measurements 34
3D volume 34
clinical measurements explained 33
Doppler measurements 35
time difference measurements 35

acoustic output

default 32
factors affecting 32
measurement 31

–

32

ALARA principle 30

,

33

auxiliary power outlet 24

B

biopsy. See puncture.
brachytherapy

warning about checking matrix 28
warning about user-defined matrixes 28
warning to verify matrix type and coordinates 28

brightness, adjusting monitor. See Getting Started.

C

caution or warning, symbol 9
Cautions

about 9
displayed on the system 43

center frequency 31
connectors for other equipment

accessing 16
location 16

picture 18

consult instructions for use (symbol) 9
contraindications 7

D

DICOM

conformance statement 16
connection if network is not isolated 21
network isolator 21
standard 16

disposing of the system 10
distorted image 14
Doppler measurements

accuracies 35
warnings 26

Doppler mode

fetal imaging 33

E

earth. See ground.
electrical noise 13
electrical safety 15
electrical shock 13
electromagnetic compatibility. See EMC.
electromagnetic interference 14
EMC

attaching cables 20
data in BZ2100 5
noise, checking for 14

precautions 14

equipment failure 11
ESD

precautions 13

symbol 10

,

13

training 13

essential performance 5
examination, performing basic. See Getting Started.
examination, viewing. See Getting Started.
explosion hazards 12
exposure level 29
extension cord, do not use 15

F

fetal imaging, acoustic output settings for 33

G

ground (earth), additional protective

adding 15
symbol 10

H

height, adjusting. See Getting Started.
HF electrosurgical equipment, warning 25

I

image distortion 11

,

14

indications for use 7
installation 15
intended use 6
isolation from line voltage 11

K

keys (basic), overview. See Getting Started.

L

leakage current 13

,

23

,

24

liquids, do not spill on system 11

M

magnetic shielding 14
manufacturer (symbol) 10
measurements, Doppler warnings 26
medical equipment

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Содержание bk3000

Страница 1: ...16 01249 EN 01 16 01249 EN 01 January 2015 January 2015 For Professional Users Only For Professional Users Only bk3000 Ultrasound System bk3000 Ultrasound System ...

Страница 2: ...SUITABLE FOR USE EXPORT RESTRICTIONS EXPORT RESTRICTIONS You acknowledge that Windows 8 Embedded is You acknowledge that Windows 8 Embedded is of US origin You agree to comply of US origin You agree to comply with all applicable international and with all applicable international and national laws that apply to Windows 8 Embedded including the U S Export national laws that apply to Windows 8 Embed...

Страница 3: ...SUITABLE FOR USE EXPORT RESTRICTIONS EXPORT RESTRICTIONS You acknowledge that Windows 8 Embedded is You acknowledge that Windows 8 Embedded is of US origin You agree to comply of US origin You agree to comply with all applicable international and with all applicable international and national laws that apply to Windows 8 Embedded including the U S Export national laws that apply to Windows 8 Embed...

Страница 4: ...llation Installation 15 15 Connectin Connecting Other Equ g Other Equipment ipment 15 15 Network Network Connectio Connection n 16 16 Network Network Security Security 16 16 Network Network Printing Printing 16 16 Connectors 16 Connectors 16 EMC Requir EMC Requirements ements 20 20 Isolation of DICO Isolation of DICOM Network M Network 21 21 Wireless Networks 21 Wireless Networks 21 Medical Equipm...

Страница 5: ...s Ranges and Accuracies d Accuracies 33 33 Geometric Measurements 34 Geometric Measurements 34 Time Measu Time Measurements rements 35 35 Doppler Measurements 35 Doppler Measurements 35 Chapter Chapter 3 3 Getting GettingStarted Started 37 37 Index Index 39 39 Appendix Appendix A A Warnings Warnings and and Cautions Cautions Displayed Displayed on on the the System System 43 43 English source vers...

Страница 6: ...siological effect and which may alter the value which can be attributed to a physiological effect and which may alter the diagnosis diagnosis D Do oc cu um me en nt t I In nf fo or rm ma at ti io on n S Sy ys st te em m U Us se er G r Gu ui id de e I In nt tr ro od du uc ct to or ry y i in nf fo or rm ma at ti io on n s sa af fe et ty y i in nf fo or rm ma at ti io on n g ge et tt ti in ng s g st ...

Страница 7: ...ended for diagnostic ultrasound imaging or fluid flow analysis of the human body data processing and guidance of puncture and biopsy The system performs simple geometric measurements and calculations in the following areas Urology Vascular Cardiology OB GYN Modes of Operation B Mode including Tissue Harmonic imaging M Mode PWD Mode CFM Mode Power Doppler Contrast Imaging1 CW Doppler2 Elastography3...

Страница 8: ... Transrectal Transvaginal Transurethral Musculoskeletal Conventional and Superficial Cardiac Adult Peripheral Vessel also known as Peripheral Vascular Indicated uses are different for different transducers The Product Data sheet for the system contains a table listing the indicated uses for each transducer that can be used with the system Contraindications The bk3000 ultrasound system is not inten...

Страница 9: ...8 Chapter1 January 2015 bk3000 User Guide 16 01249 EN 01 ...

Страница 10: ...ent Some labels in the table may appear on the transducer BK Medical disclaims all responsibility for the operating safety reliability and performance of the equipment if these symbols and warnings are disregarded in any way WARNING Warnings contain information that is important for avoiding personal injury Caution Cautions contain information and instructions that must be followed to avoid damagi...

Страница 11: ...o corresponding terminals on other equipment to eliminate potential differences Ground earth Additionalprotective ground earth Type BF BF Isolated from ground Maximum patient leakage current under Normal condition 100 A Single fault condition 500 A Type BF BF defibrillator proof Type B B Maximum patient leakage current under Normal condition 100 A Single fault condition 500 A Sealing Dust and imme...

Страница 12: ...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 Remove all transducers from contact with the patient Turn off the system Unplug the system from the power source Do not try to repair the system yourself Contact your BK Medical representative or hospital technician Isolating the system WARNING GS w3 Th...

Страница 13: ...d to a stable support so that it does not tip fall or come loose and injure someone Don t drop the scanner unit WARNING MS w3 To avoid personal injury or damage to the system if you handle the scanner unit by itself make sure you have a firm grip so that you do not drop it Note that it may be hot Don t push too hard WARNING MS w4 Toavoid injury and equipment damage do not push the system too hard ...

Страница 14: ...xceed the limits specified in EN IEC 60601 1 Electrical shock WARNING ES w3 You risk electrical shock if you try to get inside the equipment other than opening a cover to access connectors or batteries described in the user guide Do not allow anyone but qualified service personnel to service the equipment ESD Caution ESD c1 Do not touch pins in connectors that have the ESD symbol Do not connect an...

Страница 15: ...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 3MHz to 80MHz Therefore RF equipment operating in this frequency range can affect the ultrasound image However if disturbances occur they will appear as ...

Страница 16: ...stallation safety requirement WARNING I w1 To ensure safe performance a qualified electrician or hospital safety personnel must verify that the equipment is correctly installed and that it complies with the following safety requirements Use only the original power supply cord In the USA this is fitted with a hospital grade three prong grounded power plug Never try to remove or change the plug on t...

Страница 17: ...oes not meet the required characteristics of the IT network the following hazardous situations may occur Corrupt patient data due to network errors see Warning Exam w3 on page 26 System is unable to use the network due to faulty or overloaded network see Warning GS w1 on page 11 System overloads the network causing other equipment to fail Network guidelines NOTE If your system interacts with other...

Страница 18: ...stem Do not use connectors that are not labelled in Fig 2 3 More information about the connectors is in Table 2 2 Information about the cables to use is in Table 2 4 The bk3000 ultrasound system has four transducer sockets on the side of the system See Fig 2 2 Figure2 2 Transducer sockets ...

Страница 19: ...18 Chapter2 January 2015 bk3000 User Guide 16 01249 EN 01 Figure2 3 System connectors Power supply cord goes here ...

Страница 20: ...lity 2 VGA this analog output from the DVI connector gives slightly poorer image quality than the digital DVI output 3 S video analog output 4 Composite signal with the most loss of information If you must use a cable that does not have a DVI connector you may need to use an adapter Table 2 3 shows you which adapters can be used Symbol Connector Additional Information DVI I Connector for auxiliary...

Страница 21: ...and no longer than 5 m Cable Connectors in order of preference Adapter 2300 Connector HDMI Adapter needed DVI I DVI D Not needed DVI I 15 pin VGA DVI to VGA adapter 2 views DVI I BNC Composite 7 pin S video to Composite BNC female to Phone male Phono RCA Composite 7 pin S video to Composite 2 connectors S video and composite same view on both connectors 7 pin S video to S video Composite ...

Страница 22: ...archiving data A Wi Fi dongle and a 30 cm USB 3 0 extender cable are supplied with the system Connect the dongle to the extender cable and insert into one of the USB 3 0 connectors see Fig 2 3 on page 18 Connecting to a Wireless Network You must establish a secure wireless network at your hospital clinic or institution including a password for the network before you can use the system s Wi Fi for ...

Страница 23: ...e network that the system was connected to before it was turned off Weak vs strongsignal The bars in the Wi Fi logo represents the signal strength The more lit bars in the logo the stronger the signal No wireless connection When the system is not connected to a wireless network the Wi Fi logo has a red X over it An advanced Wi Fi setting option is available on the system using Windows configuratio...

Страница 24: ...on Enterpriseencryption 802 1x requires assistance from an authorized BK Medical technician Spectrum management None required Caution Wifi c1 Thenetworkmustbesetupcorrectlysothatdataissent tothecorrectlocation Otherwise data can be lost or accessed by unauthorized people Caution Wifi c2 A safe encrypted protocol for data transmission approved by the hospital must be used This is to prevent unautho...

Страница 25: ...uirementsformedicalelectricalsystems If you connect non medical equipment instruments that do not comply with safety requirements for medical equipment such as a video monitor video recorder endoscopic camera control unit or other documentation device this equipment must be placed outside the patient environment 1 5m from the bed for example The equipment must fulfill the relevant EN standard or o...

Страница 26: ...WARNING T w1 The transducer sockets contain terminals with 3 3V Do not touch the patient while you are touching an uncovered socket Type B transducers WARNING T w2 When using Type B non isolated transducers carefully check all electrical equipment within the patient area Also consider using additional protective grounding Electrical burns WARNING T w3 Do not leave transducers in contact with the p...

Страница 27: ...tact your local BK Medical representative Polygon measuring tool WARNING M w1 To prevent wrongful diagnosis you must be aware that 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 sm...

Страница 28: ...ne between the markers is perpendicular to the direction of the vessel Otherwise the real time volume flow measurement may not be precise Dopplergate large enough WARNING VFI w4 Check to make sure that the Doppler gate covers the entire vessel Otherwise the real time volume flow measurement may not be precise Dopplergate over only one vessel WARNING VFI w5 Check to make sure that the Doppler gate ...

Страница 29: ...ndication 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 Offset changes WARNING P w3 Changes you make to the offset of a programmable puncture guide or brachy matrix will affect ALL programmable puncture guides and brachy matrixes This could lead to incorrect puncture lines or matrix positions for a different...

Страница 30: ...uirements for the safety of ultrasonic medical diagnostic and monitoring equipment Prudent Use Untracked freehand WARNING 3D w2 You cannot make accurate measurements on a 3D data set acquired using the untracked freehand method Symbol Description Measurement will not be accurate PiP must not cover important information WARNING PIP 1 When you use Picture in Picture do not cover critical information...

Страница 31: ...listed For definitions of the parameters refer to the Food and Drug Administration FDA Guide as well as EN 60601 2 37 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment and AIUM NEMA standards The routes or tracks available for clearance by the FDA are well defined Track 3 is for diagnostic ultrasound systems that follow the Output Display Standard Und...

Страница 32: ...utput Measurement All values are measured in water according to the EN 60601 2 37 and AIUM NEMA display standards For some of the acoustic parameters an estimated in situ derated value is given This is derived assuming a tissue attenuation of 0 3 dB cm MHz when the estimated in situ derated value I is described by the following equation I formula where the variables are defined in the table below ...

Страница 33: ...essary the system will reduce the output voltage and or PRF pulse repetition frequency to the transducer to comply with requirements Some of the system functions can affect the acoustic output as listed here Instructions for using these functions are given in the relevant sections of this user guide Sizing functions such as ROI region of interest in general smaller size results in higher acoustic ...

Страница 34: ...nto account in this section For example The sound velocity may vary from approximately 1450 m s in fatty tissue to 1585 m s in muscle This can in simple cases give rise to errors of up to 6 for linear measurements This inaccuracy may be further increased by refraction occurring at tissue boundaries The user can introduce errors when using approximate formulas when positioning the system s calipers...

Страница 35: ...e slices and their relative orientation Toobtain the accuracies listed in the table in the Technical Data BZ2100 you must ensure that the calculation is based on contributions from at least 10 slices for very regular shapes and more for irregular shapes It must also be possible to discriminate the boundary of the object from the surrounding tissue Volume accuracy The volume accuracy in the table i...

Страница 36: ...x t where t is the full time scale of the image field Doppler Measurements In measuring blood flow velocity it is assumed that the measured power spectral distribution of the Doppler signal equals the blood cell velocity distribution The measurement accuracy of blood flow velocity is heavily dependent on the angle between the ultrasound beam and the velocity vector of the blood cells The velocity ...

Страница 37: ...36 Chapter2 January 2015 bk3000 User Guide 16 01249 EN 01 ...

Страница 38: ...bk3000 User Guide 16 01249 EN 01 GettingStarted 37 Chapter 3 Getting Started Getting Started with bk3000 forms part of this user guide ...

Страница 39: ...38 Chapter3 January 2015 bk3000 User Guide 16 01249 EN 01 ...

Страница 40: ...d 16 disposing of the system 10 distorted image 14 Doppler measurements accuracies 35 warnings 26 Doppler mode fetal imaging 33 E earth See ground electrical noise 13 electrical safety 15 electrical shock 13 electromagnetic compatibility See EMC electromagnetic interference 14 EMC attaching cables 20 data in BZ2100 5 noise checking for 14 precautions 14 equipment failure 11 ESD precautions 13 symb...

Страница 41: ...ol 9 R radio frequency interference See RF interference RF interference 14 S safety electrical 13 15 transducer 25 saving to USB See Getting Started screen controls basic overview See Getting Started sealing symbol 10 security network See network security service and repair 25 standby symbol 10 standby button See Getting Started system isolation from line voltage 11 malfunction 11 T Technical Data...

Страница 42: ...41 Wi Fi connecting to 21 correct setup and safe protocol required cautions 23 network characteristics 23 password 22 signal strength 22 using 21 wireless network See Wi Fi ...

Страница 43: ...42 ...

Страница 44: ...rent date and time s are before the scanner was last run s Check your system clock Default LCD backlight has not been adjusted Adjust default LCD backlight Failed to read general settings from database Try again Failed to save bodymark catalog Try again Failed to save label catalog Try again Frame rate has been reduced Import after upgrade has already been performed once LCD Display Colorhas not b...

Страница 45: ...cannot be used with this scanner A hardware upgrade may solve the problem Connect a compatible transducer See ProductDataSheet for more details Transducer motor overload detected on connector s Make sure the transducer can rotate freely and then start scanning again Transducer not recognized because there is an illegal CRC in block i n Contactservicetechnician Transducer not recognized because the...

Страница 46: ...ent contains an undefined measurement tool s Use a defined measurement tool A measurement cannot depend on itself An error occurred while the patient archiving database was being copied Try again Click Yes to clear the patient archive All patients in the patient archive will be lost nlick No to cancel Could not create output file n s Try again Could not create temporary subdirectory for outgoing m...

Страница 47: ...ain Failed to read catalog from database Try again Failed to read deleted Presets Try again Failed to read key action definitions from database Try again Failed to read key assignments from database Try again Failedto read key definitions from database Tryagain Failed to read measurement list from database Try again Failed to restore factory default catalogs in database Try again Failed to restore...

Страница 48: ...cters n s Fill out the required fields according to the on screen instructions License already in use Login error Please try again Name and description are required Do not leave the fields empty Fill in name and description Name and formula are required Do not leave the fields empty Fill in name and formula No catalogs available n nAssign catalogs in setup window No default propackage available fo...

Страница 49: ...h its PROM Please remove the transducer and contact a service technician The curve definition is not compatible with this software version Upgrade software The curve definition must contain x and y values The document cannot be displayed because document data is corrupted Contactservicetechnician The document cannot be displayed Try again The document cannot be displayed Currently there is no view...

Страница 50: ...eady to enter service mode nThe next time it starts the PC will start in Windows mode nPlease press the standby switch to turn off the scanner The scanner is unable to communicate with other equipment through a COM port s Use appropriate communication port s See SystemUserGuidesor contact service technician The scanner s hardware does not support s The selected curve is invalid Use valid curve The...

Страница 51: ...P To address configured nTechnical service must configure this service before it can be used There is no USB Device connected to the scanner There was a problem saving the Diagnostic Setup s Try again This scanner does not support CW Doppler This may be because of the power supply version Try again or contact service technician To view the document please insert the archive disc labeled s Unable t...

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