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- Frank`s Hospital Workshop

1. OPERATOR ee PATIENT INFORMATION EXAM N eeeee FOLDER N TAPE NAME ee ADDRESS ee PHONE HEIGHT Sog em WEIGHT kg BSA m2 BIRTHDATE SEX ESSE HR b mn OB GYN STUDIES LMP NWA wk EBD Note the LMP NWA and EBD information are always displayed on start page e The 2 icon is used to reset the whole study For more details on report menu see Appendix B Report Menu on page 7 5 C 1 1 1 Laboratory Information LAB Laboratory PHYSICIAN Physician name OPERATOR Operator name C 1 1 2 Patient Information EXAM N Exam Number FOLDERN Folder Number 15 10 01 APPENDICES 7 7 Tape NAME Patient Name ADDRESS Patient Address PHONE Phone Number HEIGHT Height in cm WEIGHT Weight in kg BSA Body Surface Area in m2 BIRTHDATE Patient birth date SEX Patient sex HR Patient Heart Rate in beats per minute This field is unused in computations it is only an information
2. OPERE ee o sra ea P ea 06 Pe P P eo o oer e P e 01876 NAME HEPIILCITP EXAM Nieeees W kg AGE y BSA m2 HR b mn CARDIOLOGY STUDIES MITRAL VALVE MV ANNULUS 2D MITRAL VALVE SP MITRAL VALVE EOA MVD cm VTI cm CONTINUITY EQUATION MVA cm2 PkV m s SAD cm M AM PkG mmHg SAA cm2 MnG mmHg VTIsa cm MITRAL VALVE TM PkVE m s em EFsl cm s PkVA m s 2 EOA cm2 ESd cm IVRT s gt PHT HEART RATE SV ml HR b mn gt SI ml m2 a F gt CO 1 mn pcm CI 1 mn m2 Ie e Lo MVD Mitral Valve Diameter in cm MVA Mitral Valve Area in cm2 ii D 2 2 2D measurements a TM measurements EFsI Slope between E and F waves in cm s ESd Distance from E wave to septum in cm b SP measurements VTI Velocity Time Integral in cm PkV VTI Peak Velocity in m s PkG VTI Peak Gradient in mmHg 7 18 SIGMA 110 SIGMA 330 15 10 01 MnG PkVE PkVA IVRT gt gt SV gt 5 gt CO gt Cl Mean Gradient in mmHg Peak Velocity for the E wave in m s Peak Velocity for the A wave in m s IsoVolumetric Relaxation Time in second Ratio Peak V
3. 7 95 K 2 Cardiology Measurements 2 7 95 Vascular measurements 7 102 K 4 Obstetric and Gynaecology 22 020 4 444 4 7 104 K5 s uoi ei E RR Last lU ERAI MINIM 7 108 K 6 Multiple associations ue a Mond tin el 7 109 Appendix E Body Markers ces 7 111 b TSU dob n te wu ec s hb an oae etre cim tte nct 7 111 EZ Radiology Ed s eU 7 111 es Obstetrics Gynaecolagy iik taie od PEU ota EDS EAE RECO 7 112 54 E I 7 112 Appendix M Acoustic Output Tables 7 113 M 1 Track3 Summary Tables 7 113 M 2CDennitiorn aor Terms d dati e tau tard de teat alec 7 114 M 3 Acoustic Output Tables deiepeicdecc oo ora En Eo rte een 7 116 xiv SIGMA 110 SIGMA 330 10 12 01 H 4 KONTRON MEDICAL Intended Clinical Use and Safety Information This system complies with the Medical Device Directive MDD 93 42 EEC according to which KONTRON MEDICAL has classified this device as a Class 1 Type B device Note for U S Customers U S Federal Law restricts this device to sale distribution and use by or on the order of a physician 1 Clinical Use The SIGMA 110 330 is
4. 5 21 5 5 18 Error 17 Internal communication Fatal 5 21 6 OPTIONS AND 5 5 8 222 6 1 lt Diei sende ruo des Lad ede EE 6 3 5 2 EISUOLPTODOS 6 4 6 3 PCC OS 6 5 f APPENDICES A ae 7 1 Appendix A Overview 7 3 Entering the BIOImelly iunii ce t noti e n Ex d b d e Ra ds 7 3 2 Exiting Biometry 7 3 Make Measurement from 7 3 A 4 Importing Measurements in 22 0000000 00 7 4 Appendix B Report 7 5 Appendix C Patient Information 7 7 el First Page eH 7 7 2 56 Page de ed 7 9 SIGMA 110 SIGMA 330 10 12 01 H 4 KONTRON HAN MEDICAL Appendix D Cardiology 7 11 D 1 Left Ventricle Study cst i cick tad Scatter std oa pre 7 12 0 2 Mitral Valve Study uo sk tele kale t equi aa 7 18 9 3 Teile ello M M HM 7 22 D 4 Right Ventri
5. 5 18 5 5 1 Error 0 Internal unexpected 2 5 18 5 5 2 Error 1 not restore backed up configuration 5 18 5 5 3 Error 2 Tracking problem Fatal 5 19 5 5 4 Error 3 Memory allocation error Fatal 5 19 5 5 5 Error 4 Divide by O0 Fatal error 5 19 5 5 6 Error 5 Communication GION ce sce heel ttc olen dak eile alte cael 5 19 5 5 7 Error 6 Flash card read error uin Ir UR e OSEE 5 19 5 5 8 Error 7 Flash card write 44444 1 5 19 5 5 9 Error 8 Invalid flash Card 1 P t tate qe tee tene 5 20 5 5 10 Error 9 Ob Gyn restore 2 nennen 5 20 5 5 11 Error 10 Flashcard not correctly 5 20 5 5 12 Error 11 Internal Communication Fatal 5 20 5 5 13 Error 12 Cannot program 5 20 5 5 14 Error 13 CFM Frame Filler LUT Error eiii 5 21 5 5 15 Error 14 CFM Function LUT ETEOE ido iro rti treno te ges 5 21 5 5 16 Error 15 CFM LUT programming time out 5 21 5 5 17 Error 16 Flashcard removed while
6. EMEN 4 8 4 3 2 Manufacturer 4 9 44 Product Recycling and Disposal ice tat dea capui e mendes 4 10 5 TROUBLESHOOT UN Gite calc stated hh uta t actore 5 1 5 1 Handle Error and Warning Messages cceccceeceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeaaaaaeeaeeees 5 3 5 2 INUOCUGCTON and RU IGS su sac re EIE donee ae oe aaron aad 5 4 52l PIBIBS estas awit detains 5 4 5 28 2 autre eu analis 5 4 5 023 HACINGIKS ieee 5 4 5 3 Status 55 ca 5 5 10 12 01 TABLE OF CONTENTS xi H 4 KONTRON HIXMEDICAL cc 5 5 5 3 2 Measurement and 5 7 5 3 3 Transmit Voltage ae enl vices eeu teer 5 8 aot 5 9 54 1 Startup CIS KS axeeteo Tn M a bn 5 9 5 4 2 System Configuration 2 200 40 5 10 543 Flash card and SPAM cote cited ir ep ea dne bep n e oreet 5 11 5 4 4 Miscellaneous checks cese metet EL Fa ERR 5 13 5 5 General Failures and Errors 2 5 otia
7. ali ee e er 0 CRL from Jeanty t EBD week week EBD week 3 CRL cm G 8 3 1 Source Chervenak F A Jeanty P_ Hobbisn J C Current Status of Fetal Age and Growth Assessment 15 10 01 APPENDICES 7 73 AVA KONTRON MEDICAL G 8 4 CRL from Hansmann CRL cm EBD week se p up 8e EBD week EBD week f amp EBD week CRL cm G 8 4 1 Source Dr HAnsmann Ultraschalldiagnostik in Geburtshilfe und Gyn kologie pages 419 to 421 Springer Verlag ISBN 3 540 11428 9 7 74 SIGMA 110 SIGMA 330 15 10 01 8 5 CRL from Rempen 3 a EIER a een 94 08 WERE UE DIES JR 45 04 99 lcu pM ENSE AI NN y 98 from Rempen 1 EBD week EBD week EBD week 4 CRL cm 15 10 01 APPENDICES 7 75 H 4 KONTRON BAY MEDICAL G 9 Gestational Sac GES G 9 1 GES from Ramzin GES cm EBD week oy s 12 6 9 1 1 Source Dr Ramzin Basel Sound Velocity 1540m s Uncertainty two standard deviation G 9 2 5 from Hellmann GES EBD EBD week G 9 2 1 Source Provided by the marketing Adapted from Hellmann Am J Obstet Gyne col 103 7
8. 3 110 3 20 3 Entering PC remote control 3 111 3 20 4 PC remote control features description 2 4 3 111 3 20 5 Leaving PC remote control 3 111 3 20 5 Keyboard inm PC Moder siis teste settle bese hace 3 111 3 20 7 Errors War niNGSvc Gouna Ra ERAN D 3 114 3 20 9 PCCDOWOE ION 3 114 3 20 9 VPG DOWD 3 114 3 20 10 3D VascularView and 3D FetalView 3 115 cm WPAGCS 3 115 3 20 12 Connection to a Network cereo kn aite aquis austenite 3 115 3 20 13 Installation of peripherals 3 D ER IRE EORR ERI 3 115 4 JMAINTENANGE eto dieu c ib xcu tur es 4 1 4p tasto is f 4 3 SUE MEM io UL T E 4 3 252 7 ape vere t ER 4 3 41 3 EYE Q 300M MOFPIUDE a 4 3 4 1 4 4 3 1585 Instrumenti DES 4 4 DISN e t N m 4 5 4 3 Repairs 4 8 4 3 1 User
9. Figure 1 15 Function Keys A specific menu exists for each mode The current menu is automatically displayed when enter ing mode For example pressing 2D key enters 2D mode and displays 2D menu MK key is used to display or hide menu keys are used to access previous next menu page when more than one is available There are two types of displayed menu single or double a Single Menu is displayed on 1 line and consists of 5 Menu Items M1 to M5 lll F2 F3 F4 F5 FPO F2 F3 F4 FS Figure 1 16 Single Menu Display For Single Menu the Fi and Fi keys have the same action Press indifferently F1 or F1 to select M1 menu item a Double Menu is displayed on 2 lines and consists of 10 Menu Items M1 to M10 1 36 SIGMA 110 SIGMA 330 15 10 01 1 De fe bw be M6 M7 M8 9 10 1 2 5 6 F7 F8 F9 F10 Figure 1 17 Double Menu Display 1 5 2 2 PopUp Menu Used for Labels and Body markers When activating label or body marker menu a list is displayed in place of the technical and measurement data More details on labels and body marker management are available in Appendix L Body Markers on page 7 111 15 10 01 INSTRUMENT DESCRIPTION 1 37 1 5 3 Technical Data Area This chapter describes technical data of SIGMA 110 330 in the diffe
10. 7277442 7424 272 22222427 047 APP PPP 222222 47 27272242 222 2 2 2 44742 422 2222222724272272 222 4242 4 n 2 7 2 222 222 7 2 22222 222222222242224774 2477 7 7 7 7742247 27227 2 22 777772422744 7 7 4 47 4 N 95955553 77727777 27 27 Figure 3 3 Quad 2D Selection 10 12 01 OPERATING INSTRUCTIONS 3 27 AVA TRON MEDICAL 3 7 1 2 2D Live Menu This menu is displayed in active 2D mode 3 28 Angle Dual zoom Freqy Biopsy page 1 2D Inv Right Tilt vis 1 ed smoot Reject 2 This function allows the user to modify the angle of the image sector for Annular Sector and Convex probes Use the MP potentiometer to select the desired angle For available angles see table ii Probe Features on page xviii Single Dual Quad This function displays single double and quad multi format Select Dual to display double 2D images then select Quad to display quad 2D images and select Single to return to sin gle 2D image In dual mode press 2D to return to single 2D Zoom Panoramic Zoom for Annular Sector probes Press Zoom to magnify an area of the ultrasound imag
11. L Information concerning Mother GRAVIDITAS Number of pregnancies Term Number of birthes having reached time Prema Number of premature birthes Abortion Number of abortion Living Number of alive infant at birth Information concerning Foetus FOETAL HEART RATE FOETAL MOUVEMENT FOETAL BREATHING GENDER most likely sex made on 2D images PRESENTATION 15 10 01 APPENDICES 7 43 H 4 KONTRON MEDICAL F 4 Setup Sheet F 4 1 Description The calculations collected in the obstetric gynaecology package are designed to estimate the age of a foetus according to the size of a specific body element e g femur length thoracic diameter The age is subsequently determined using a reference table where a linear inter polation is made for each measurement which lies between two tabulated points For each measurement the user can use his personal table see Appendix 5 User Table Sheet on page 7 47 or a reference table To select the curves he wants to work with the user must enter the user setup sheet by selecting the 4 softkey The following screen is then displayed P d First Page 14 02 01 08 30 31 OB GYN SETUP ChD CRL Rempen BOD Robinson User Jeanty Hohler User Chev Jean BPD Hansmann Bessis OFD Rempen Merz Merz User Hadlock User Campbell GES Chev Hobb HC Ramzin Hohl Sabb Hadlock Hellman Hansmann Merz Hansmann Lai Yeo Lai Ye
12. a E NAMES DRE EXAM Nieeeee W kg AGE BSA m2 HR b mn CARDIOLOGY STUDIES RIGHT VENTRICLE PULMONIC VALVE 2D TRICUSPID VALVE TM CONTINUITY EQUATION DEsl cm s Diaml cm AREA1 cm2 PULMONIC VALVE SP TRICUSPID VALVE SP VTI1 cm VTI cm TRV m s VTI2 cm PkV m s gt RVRAGr mmHg Area2 cm2 PkG mmHg VEL1 m s MnG mmHg VEL2 m s RVPEP s HEART RATE AREA2 cm2 SV m1 HR b mn SI ml1 m2 CO l1 mn CI l1 mn m2 Ie e la i D 4 2 Pulmonic Valve a 2D measurements PAD Pulmonary Artery Diameter in cm b SP measurements VTI Velocity Time Integral in cm PkV VTI Peak Velocity in m s PkG VTI Peak Gradient in mmHg MnG VTI Mean Gradient in mmHg PHT Pressure Half Time in millisecond RVPEP Right Ventricle Pre Ejection Period in second gt SV Stroke Volume in millilitres gt 5 Stroke Volume Index in millilitres per square meters gt CO Cardiac Output in litres per minute gt Cardiac Output Index in litres minute per square meters 0 4 2 1 Tricuspid Valve a TM measurements DEsl Slope between D and E wave in cm s 7 26 SIGMA 110 SIGMA 330 15 10 01 b SP measurements TRV Tricuspid Regurgitation Velocity in m s gt RVRA
13. BPD from Lai Yeo 6 8 BPD cm e EBD week 11 EBD week k EBD week G 1 8 1 Source FM Lai G S H Yeo Reference Charts of foetal biometry in Asian Singapore Med J 1995 Vol 36 628 636 7 56 SIGMA 110 SIGMA 330 15 10 01 G 2 Chorion Diameter ChD from Rempen 15 10 01 ChD cm EBD week 1 5 71 1 4 25 74 a2 se 14 1073 ra ChD from Rempen EBD week week EBD week 4 ChD cm APPENDICES 7 57 H 4 KONTRON BAY MEDICAL G 3 Femur Length FML G 3 1 from Bessis Sm I 95 7 ME a FML from Bessis EBD week lt week 14 EBD week 4 FML cm G 3 1 1 Source The data are those provided by Dr Bessis to M Le Bel Same as SIGMA 20 see memo from Ch Gahwiller dated June 23 1983 7 58 SIGMA 110 SIGMA 330 15 10 01 G 3 2 from Hadlock FML from Hadlock 1 EBD week week EBD week 4 FML cm G 3 2 1 Source publication Title Fetal Femur Length as a Predictor of Menstrual Age Sonographically Measured Authors F P Hadlock R B Harrist R L Deter S K Park Reference Americal Journal Roentgenology Vol 138 May 1982 15 10 01 APPENDICES 7 59 AVA KONTRON MEDICAL G 3 3 FML from O Brien FML cm EBD week ee
14. 0 application Vasc velocity range kHz 250 steering angle degrees 0 Notes a This index is not required for this operating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is not reported for the reason listed 7 122 SIGMA 110 SIGMA 330 15 10 01 4 MEDICAL Transducer Model 7 5 MHz LVS Operating Mode Color Flow Doppler TIS TIB TIC non scan Index Label MI non scan Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value a 1 8 b Pr3 MPa 2 Wo4 mW 49 1 min of W_3 21 lr 3 z1 mW 21 aM S gt E Zsp cm 9 deq Zsp cm B fc MHz 6 13 2 x cm 0 77 Im O 2 0 65 2 m PD msec 1 40 6 Hz m Pr Pllmax MPa deq QPllmay cm Se ere FLy cm 2 30 Len E FL om 28071775 IpA 3Mlmay W cm depth cm 3 Doppler frequency MHz 6 1 color depth min _ color angle min g resolution med 5
15. Ik co ID n Archiving Ok Cancel The functions are the same as for the PRINT2 configuration Config Key The Config Key is used to enter the keywords that enable the EasyPrint options These keywords are provided by the factory 3 20 SIGMA 110 SIGMA 330 10 12 01 Renting Key Press this key for entering new time renting credit to the system These keywords are pro vided by the factory KIPRISM With the KIPRISM key the user can select a black background or a white background when storing images on memory card Store images on flashcard with 1 Black background as on screen 2 White background recommended when printing on ink jet printer Ok Press alphanumeric key 1 to select a black background Press alphanumeric key 2 to select a white background This option is recommended when printing on ink jet printer Q Depth encoder Depth encoder preference allows the user to select the sense of the DEPTH encoder Increase depth when turning DEPTH encoder 1 Clockwise 2 Counterclockwise Cancel Press alphanumeric key 1 to select Clockwise turning the Depth encoder clockwise increases depth Press alphanumeric key 2 to select Counterclockwise Q Printer Setup Press this key to display the screen for setting the printer parameters s
16. 2 Physician Operator ROW3 secoecoooooooo 44 44 Page number FOOTER Q EFT ENT R RIGHT e Sone OT a ana E a SiS ei os e a y Re a Fagen O ROW3 SSystem 2 4 4 44 4 HH pageNumber Header mm Default amp Footer efau Three lines are reserved for the header three others are for the footer On each line three places are available right aligned centred or left aligned A popup menu is displayed on the right side of the screen It contains the name of some prede fined system variables date and time operator The user may select one of these system variables to place it in any field Note that the KONTRON MEDICAL copyright and the system type are printed left aligned on the third line of the footer Cf Copyright and System values on page 2 30 This field cannot be neither moved nor deleted Definition of the header and footer 10 12 01 INSTALLATION 2 29 AVA KONTRON MEDICAL The definition of the footer and header is equivalent Using the trackball the user selects a location The selected field is displayed in inverse video Now if the user presses the backspace key the selected field is deleted Else if he presses the Enter key or the up left trackball key the edition mode is turne
17. 1 60 1582152 Measurements 1 60 1 9 145 hu 1 61 I tia edet tetur eva hb et ru Ra Messe irae 1 62 1 8 16 Regulation etl 1 62 1000 4 DIMACMSIONS soe retia erit p teo dete vio eb enims cibi iot bcp halten Vinos e 1 62 2 INSTALLATION zie eda us ru P ciue qi ecc 2 1 2 1 nstallaton Hequlremiel Md t teda i i ed edi duda 2 3 Zoo UNnpa ettam a ott 2 3 enn 2 3 2 2 2 2 3 2 3 Checking the Instruments Identification 2 3 24 Checking the Delivery a ei eek eee een 2 4 2 5 MEETS 2 6 2 6 Installation of SIGMA 330 Expert SIGMA 330 Excellence 2 7 2 6 1 Installation of the integrated Cart iiie hdi ao eee erated leat 2 7 2 6 2 Installation of the flat panel monitor 2 8 2 6 3 Installation of the integrated compact PC SIGMA 330 Excellence only 2 8 2 7 POWER Source sn seti
18. application Vasc velocity range Hz 250 steering angle degrees 0 Notes a This index is not required for this operating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is not reported for the reason listed 15 10 01 APPENDICES 7 121 4 KONTRON MEDICAL Transducer Model 7 5 MHz LV Operating Mode Color Flow Doppler TIS TIB TIC non scan Index Label MI non Sea Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value a 1 6 E b Pr 3 MPa 2 Wo4 mW 43 6 min of W 3 z1 3 21 mW G7 cm A 2 2 zm E Zsp cm s 9 deq Zsp cm g fc MHz 6 13 lize 0 88 Dim of Aaprt lt 0 45 PD msec 1 40 6 PRF Hz S Pr PIlmax MPa deq QPllmay cm FLy cm 2 07 Len 3 FLy 207 IpA 3Mlmax W cm depth cm 4 Doppler frequency MHz 6 1 color depth min _ color angle min g resolution med 5 wall filter off
19. 9 Notes a This index is not required for this operating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is not reported for the reason listed 7 134 SIGMA 110 SIGMA 330 15 10 01 H 4 KONTRON BAY MEDICAL Transducer Model 6 5 MC Operating Mode PW mode TIS TIB TIC Index Label MI TOTAM sean Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value a 25 40 Pr3 MPa g Wo mW z z 1274 E min of W 3 z4 lr 3 z4 mW 92 8 Gi cm 1 12 5 1 12 n cm 2 55 eq Zsp cm 0 37 i fc MHz 4 10 4 10 2 x cm 0 67 0 67 lt ow 0 65 0 65 PD msec 10 08 10 08 6 Hz Pr Pllmax MPa deq QPllmay cm 0 35 Focal Length ion ied Q Fly cm 3 07 3 W cm application Vasc Vasc 5 Doppler frequency MHz 4 4 gate size mm 8 8 8 velocity range kHz 3 2 3 2 energy dB 0 0 Notes a This index is not required for this operating mode see
20. page 2 Ratio Undo 3 14 4 CFM Measurement page 1 This is only available if CFM mode is installed on the SIGMA system Refer to table 1 3 System configuration and options on page 1 6 for SIGMA systems with CFM CFM measurement menuA psa Area Angle eem Freq 4 Ratio Undo The CFM measurement menu contains all the 2D measurements and some specific CFM meas urements a CFM velocity mode the velocity and the frequency measurement both are measured at the calliper posi tion the velocity profile measurement the velocity is measured and displayed along a line a CFM power mode velocity and frequency measurement not available power profile measurement the power is measured and displayed along a line The blood flow measurement is available only in CFM SP mode When entering in the CFM measurement menu the distance measurement is set by default 3 14 4 1 Distance See 2D Measurement Chapter 3 14 3 1 Measuring a Distance on page 3 69 3 14 4 2 Area See 2D Measurement Chapter 3 14 3 2 Measuring an Area on page 3 70 3 14 4 3 Ellipse See 2D Measurement Chapter 3 14 3 3 Measuring an Ellipse on page 3 70 10 12 01 OPERATING INSTRUCTIONS 3 75 AVA KONTRON MEDICAL 3 14 4 4 Angle See 2D Measurement Chapter 3 14 3 4 Measuring an Angle on page 3 71 3 14 4 5 Velocity Technical Data
21. pisce Area Ellipse Angle Veloci Freq Prot Ratio Undo The CFM velocity measurement is made by setting one point on the image The CFM velocity at this point is computed according to the current image format velocity range and is displayed in cm s or m s on the right side of the screen 3 14 4 6 Frequency Technical Data oistance Area Ellipse Angle eei Freq 1 Prot Ratio Undo The CFM frequency measurement is made by setting one point on the image The CFM fre quency at this point is computed according to the current image format velocity range and is displayed in kilo Hertz on the right side of the screen 3 76 SIGMA 110 SIGMA 330 10 12 01 3 14 4 7 Velocity Power Profile Technical Data Legend Positive Velocity Negative Velocity l pistance Ellipse Angle eoe Freq Vel zl Ratio Undo The CFM Velocity Profile measurement is made by setting two points on the image When the second point is set a graphical display of the CFM velocity or power from each point of this line will be made No results are displayed on the right side of the screen 3 14 4 8 Ratio See 2D Measurement Chapter 3 14 3 6 Ratio on page 3 73 3 14 5 TM Measurement If you press on MEASURE key in TM mode SIGMA 110 330 displays the following menu Distance Slope Heart Rate
22. 6 3 3 1 Source Jeanty P Rodesh F Delbeke D Dumont J Estimation of Gestational Age from Measurements of Fetal Long Bones J Ultrasound Med 3 75 1984 G 3 4 FML from Jeanty 1 004 5 1 a 5 899 a Ce cn FML from Jeanty EBD week EBD week 4 amp EBD week 4 FML cm G 3 4 1 Source Jeanty P Rodesh Delbeke D Dumont J Estimation of Gestational Age from Measurements of Fetal Long Bones J Ultrasound Med 3 75 1984 7 60 SIGMA 110 SIGMA 330 15 10 01 G 3 5 FML from Hohler 1 FML cm EBD week E gt mc FML from Hohler FML cm G 3 5 1 Source Hohler C W Quetel T A Fetal femur length Equations for computer calculation of gestational age from ultrasound meas urements Am J Obstet Gynecol 143 479 481 1982 15 10 01 APPENDICES 7 61 AVA KONTRON MEDICAL G 3 6 FML from Hansmann ee a 4 8 3x 3 88 3 33 FML from Hansmann EBD week week EBD week FML cm G 3 6 1 Source Prof Dr Hansmann Prof Dr Hackel er und Prim Prof Dr Staudach Ultras challdiagnostik in Geburtshilfe und Gyn kologie p 413 418 ISBN Nr 3 540 11428 9 Springer Verlag 7 62 SIGMA 110 SIGMA 330 15 10 01 G 3 7 from Merz
23. Velocity at Diastole Veld Venddiast_AUT r Ob Fet 1 Ratio Velocity Systole Diastole Umbilical Artery Vels Veld S D_AUT r Ob Fet 1 Description SIGMA Sono Win Chapter Pulsatility Index PI PI AUM Ob Fet 1 Mean Velocity TAMX m s VTAMX AUM cm s Ob Fet 1 Velocity at Systole Vels m s Vsyst AUM cm s Ob Fet 1 Velocity at Diastole Veld m s Venddiast AUM cm s Ob Fet 1 e Ratio Velocity Systole Diastole Vels Veld S D AUM Ob Fet 1 Resistance Index RI RI AUM Ob Fet 1 Velocity at Systole Vels m s Vsyst AUM cm s Ob Fet 1 Velocity at Diastole Veld m s Venddiast AUM cm s Ob Fet 1 e Ratio Velocity Systole Diastole Vels Veld S D AUM Ob Fet 1 Cerebral Artery Description SIGMA Sono Win Chapter Pulsatility Index PI PI ACM Ob Fet 1 Mean Velocity TAMX VTAMX ACM Ob Fet 1 Velocity at Systole Vels Vsyst ACM Ob Fet 1 Velocity at Diastole Veld Venddiast Ob Fet 1 Ratio Velocity Systole Diastole Vels Veld S D ACM Ob Fet 1 Resistance Index RI RI ACM Ob Fet 1 Velocity at Systole Vels Vsyst ACM Ob Fet 1 Velocity at Diastole Veld Venddiast Ob Fet 1 Ratio Velocity Systole Diastole 15 10 01 Vels Veld S D ACM APPENDICES Ob Fet 1 7 107 4 KONTRON MEDICAL
24. Burst Bursts are short transient pulses on the mains power line They may cause white or black dots in 2D or TM mode coloured dots in CFM and can be heard or seen as dots in Doppler mode The effects created by bursts are not correlated with the ultrasound information There fore they may be well distinguishable from the true ultrasound echo Immunity restriction Electromagnetic fields in the environment of the ultrasound system may cause white or black patterns in 2D or TM mode coloured patterns in CFM and can be seen as horizontal lines in Doppler mode Especially in the Doppler modes CW and PW some lack of immunity may be observed in a narrow frequency band of 20 kHz at the used frequency and its multiples Typically the transducer acts like the reception antenna and the effects are stronger when it is applied to patient In any case the effects are not correlated with the ultrasound information therefore they may be well distinguishable from the true ultrasound echo Electro Surgical Units ESUs Electro surgical units or other devices that introduce radio frequency electromagnetic fields or currents into the patient may interfere with the ultrasound image An electro surgical device in use during ultrasound imaging will greatly distort the 2D image and render Doppler modalities useless Information about Reusing Recycling In this system the packing materials are reusable and recyclable the unit casings plastic and
25. Load SETUP replaces working parameters of current probe by parameters saved in the SETUP Save SETUP Save working parameters of current probe as preset values Preferences Date amp Time Doppler Scale m s or kHz Printer Selection Patient ID Tech nical Data Cine Mode and Refresh setup 1 4 2 Live Investigation Keys 1 4 2 1 FREEZE Key The FREEZE key is a toggle key starting and stopping image scanning This key is always ena bled Action on freeze key displays menu of current mode on the screen When the report is dis played action on freeze key exits report and displays live ultrasound image This key includes a relief mark for easy tactile recognition 1 4 22 PRINT 1 and PRINT2 Keys The PRINT1 and PRINT2 key control video printers The PRINT1 key is always enabled and attached to a B amp W video printer The PRINT2 key can be configured for colour video printer or for digital archiving KIPRISM The configuration can be done with the SETUP menu Just before start printing the live image is frozen and any menu removed from the screen Just after printing previous system state is automatically restored 1 4 2 3 2D Key The 2D key sets the system in 2D mode not all probes are 2D compatible 1 4 24 TM Key The TM key sets the system in TM mode not all probes are 2D compatible 1 4 2 5 Key key sets the system CFM mode only if linear probes are attached to the system mecha
26. Quad 2D Modes In these modes the technical data window contains the information concerning the active image See Chapter 1 5 3 2 2D and 2D TM Technical Data on page 1 39 1 Only one of the thermal or the mechanical index will be displayed at a time 15 10 01 INSTRUMENT DESCRIPTION 1 39 TRON AVA ICAL KON MED 1 5 3 6 2D SP 2DV SP Technical Data These technical data contains the 2D data and also the PW ones Probe Probe Appl name Application Depth xx cm BGainxx 2D Gain Quality Freqt Smooth x Smooth Enhance Enh x Rej x Reject Gamma Gamma x Rainb x Rainbow Zoom Factor ag x x TI xx x Frame Rate PW CW PW DGainxx Doppler Gain SPFreq x x MHz Vectxx Vector SPWall Filter WxxxxHz En xxdB SP Energy GateSize Gatexxmm TI xx x TIx MIC a Zoom mode only b PW mode only c only displayed when image is active and live 1 5 3 7 and Technical Data The most relevant CFM information are displayed here Probe Probe Appl name Application Sub Application Subappl name Depth cm CGainxx CFM Gain Resolution Res Low Pers x Persistence CFMFreq x x MHz xx fps Frame Rate Color Map ColMapx En xxdB CFM Energy 2D Gain BGain xx Zoom Factor Mag Tix only if Mag or Zoom is on b in live mode only When Color Off is pressed the 2D technical data are displayed See Chapt
27. 1 14 lt ow 1 14 PD msec 10 1 6 Hz m Pr Pllmax MPa deq QPllmay cm 0 21 fs Focal Length iod c i i Fly cm may W cm application Vasc 5 Doppler frequency MHz 4 gate size mm 8 6 velocity range kHz 3 2 energy dB 0 Notes a This index is not required for this operating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is not reported for the reason listed 15 10 01 APPENDICES 7 117 4 KONTRON MEDICAL Transducer Model 7 5 MHz LV Operating Mode PW mode TIS TIB TIC non scan Index Label MI non Sean Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value a 1 9 1 4 b Pr3 MPa 2 Wo mW 38 3 min of W 3 4 3 21 mW 21 0 Giu cm 1 07 A 26 cm 1 07 Zsp cm 1 96 9 deq Zsp cm 0 31 d fc MHz 8 19 8 19 Slice 0 88 0 88 Dim of Aaprt lt 0 45 0 45 PD msec 10 5 10 5 6 PRF Hz p Pllmax MPa 5 deq Pllmax 0 30 e
28. 3 51 3 11 1 Image Storage and Freeze 00 3 51 3 11 2 Archive Display of Stored 244444044422 3 52 3 11 3 Using the Memory on PC sess ieee 3 54 3 11 4 Patient Report and Patient ID with KIPRISM 3 55 3 12 AMMOLATIONS I 3 59 3 12 1 Entering Annotation 811111 3 59 3 12 2 Exiting the Annotation 04 444444 3 59 3 12 3 Manual dextADotellQFi ecc aro 3 60 312 4 Labels NECEM 3 60 3125 tad i da on a RE RR clan ein CREAR EUR BARRE EA 3 64 usate oet iaai 3 65 3 13 1 Displaying Body Mar Kel vs ER DuC 3 65 3 13 2 Moving Body Markers o ea DRds 3 66 3 13 3 Deleting Body markers tte rini loi on cob e la sea 3 66 3 19 d INN el pee uite 3 66 3 13 5 Deleting All Annotations euntibus ince tpi eb bata d abad ee nls 3 66 3 14 Measurements onto stor a ite eae 3 67 3 14 1 Generalities REL 3 67 3 14 2 Starting a Me
29. Selects a medical application 3 13 5 Deleting All Annotations Select ClearAll to clear the screen of all annotations 3 66 SIGMA 110 SIGMA 330 10 12 01 3 14 Measurements Measurement can be made on any image Callipers are available from 2D Mode TM Mode Doppler spectrum and CFM to measure distances areas angles times slopes velocities etc The results are automatically displayed on the screen Up to ten results of the most recent meas urements can be displayed on the right side of the screen 3 14 1 Generalities 3 14 1 1 Entering the Measurement Mode To enter the measurement mode press the MEASURE key The MEASURE Menu is displayed on the screen and ultrasound image is frozen 3 14 1 2 Quitting the Measurement Mode Press FREEZE key to quit the MEASUREMENT mode and return to live image of the current imaging mode Press MEASURE key to quit the MEASUREMENT mode and return to frozen image of the cur rent imaging mode 3 14 1 3 Validation Keys Generally the trackball is used to move something on the screen The trackball is joined with two validation keys upper trackball keys one or the other have the same function These keys are named SET in the following description The trackball and attached keys are used to perform measurements 3 14 1 4 Other Useful Keys a Undo Soft Key With the Undo key the user can delete one by one the different measurements he has made last i
30. key selects 3 Leeete the next image found 6 4 Icons the list The menu is automatically updated If only one image is stored this key is disabled a The 4 key selects the previous image found in the list The menu is automatically updated If only one image is stored this key is disabled The Delete key deletes the image A dialogue box appears for a confirmation If the user chooses Ok the image is deleted and the program returns automatically to the thumbnails mode After this action the UNDO key is enabled a The Icons key returns to the image panel mode 3 11 2 5 Exit Archive mode a The keys allowing to quit this mode are ESCAPE FREEZE and PROBE a The POWER_OFF key is always enabled When the user exits this mode all deleted items are definitely erased and lost 3 11 3 Using the Memory Card on PC The memory card can be used on a standard Personal Computer equipped with a PCMCIA card reader See Chapter 2 9 3 Archiving on Personal Computer on page 2 17 for recommended PCMCIA card adapter With KIPRISM image files PCX and report files TXT can be saved on a SRAM via the SIGMA PCMCIA drive These files can be read directly on a PC via its PCMCIA drive using an image editor for image files and a text editor for reports File name consists of 8 characters for the actual name plus 3 characters for the file name exten sion The name 8 characters is split into two
31. 8 8 velocity range kHz 3 2 3 2 energy dB 0 0 Notes a This index is not required for this operating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is not reported for the reason listed 7 120 SIGMA 110 SIGMA 330 15 10 01 4 MEDICAL Transducer Model 3 5 MHz CV Operating Mode Color Flow Doppler TIS TIB TIC non scan Index Label MI non scan Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value a 1 1 Pr3 MPa 2 Wo4 mW 63 8 min of W 21 3 21 1 mW 21 A 2 E Zsp cm 9 deq Zsp cm fe MHz 3 1 2 x cm 1 28 Im o 2 cm 1207 z PD msec 3 90 6 Hz m Pr Pllmax MPa deq QPllmay cm Se ere cm 6 40 Len s FL om 640 IpA 3Mlmay W cm depth cm 15 Doppler frequency MHz 3 10 color depth min _ color angle min g resolution med 5 wall filter off 0
32. A Double Menu consists of two Menu ltem rows that contain one character line each see figure 1 17 Double Menu Display on page 1 37 3 4 4 Menu Display Note that the menu corresponding to the active mode is automatically displayed when the user enter the mode The user can also press the PRE VIOUS lt or NEXT gt keys to access in a circular fashion the previous or next menu page if more than one menu page exists in the current menu Note the gt symbol in the lower right corner of menu field M5 M10 20 is only displayed if more than one menu page exists 10 12 01 OPERATING INSTRUCTIONS 3 7 To hide and disable a menu press the MENU key The menu is hidden during the print phase and displayed again when printing is finished 3 4 5 Menu Items There are two types of menu items selectable and incremental a Choosing a selectable menu item causes the action to be carried out immediately when the associated key is pressed Choosing an incremental menu item dedicates the incremental potentiometer to the current action when the associated key is pressed The Symbol is used to identify an incremen tal menu item e g for Angle or Vector adjustment The related Function keys F1 to F10 are used to select Menu Items see figure 1 16 Single Menu Display on page 1 36 and figure 1 17 Double Menu Display on page 1 37 3 4 5 1 Selectable Menu Items Selectable Menu Items The user on
33. Patient identification field including patient name clinic name operator name time and date 1 SIGMA 330 Excellence only 1 54 SIGMA 110 SIGMA 330 15 10 01 Technical data field showing all pertinent imaging parameters Measurement field displaying the last ten measurement results Menu field activated by the corresponding function key Freeze mode indicator Cine loop memory index Annotation arrows and user defined annotations with trackball controlled positioning Image orientation indicator Over 51 body markers with scan plane indication Indication of CFM ROI position and size Dot lines for TM CW PW beam orientation Real time ECG trace display Biopsy channel indication with automatic calibration of depth probe type left right guides and angle up down orientation CFM window SETTINGS Default settings related to the medical application and transducer for image quality opti mization User settings memorized in the system as well as on a flash card 1 8 2 2D B Mode SCANNING SECTOR Angle 40 45 60 75 90 110 and 140 for Annular Sector Probe dependent Angle 30 45 60 75 90 and 110 for Convex Array Probe dependent Depth 2 cm to 24 cm up to 10 depths Probe dependent Nominal frequency range 2 to 14 MHz Probe dependent FRAME RATE Upto 218 fps Depending on depth angle and medical application SIGNAL PROCESSING Large bandwidth 1 5 18 MHz Overall Gain 32 steps Time Gain Compensa
34. Table 7 2 Track 3 Summary Table Possible Operating Modes Linear and Convex Probes Transducer Model 7 5 LVS 6 5VMC 3 5 MC Operating modes B Mode M Mode PW Doppler CW Doppler Color Doppler Combined Other 15 10 01 APPENDICES 7 113 Table 7 3 Track 3 Summary Table Possible Operating Modes Doppler Probes Transducer Model Operating modes M Mode PW Doppler CW Doppler Color Doppler Combined Other M 2 Definition of Terms For each transducer mode combination checked with a in table 7 1 on page 7 113 table 7 2 on page 7 113 and table 7 3 on page 7 114 an output reporting table is given in Chapter M 3 Acoustic Output Tables on page 7 116 The symbols used in the acoustic output tables are explained below MI TlSnon scan TIB Aaprt pr3 Wo 2 3 21 7 114 mechanical index soft tissue thermal index in auto scanning mode soft tissue thermal index in non autoscanning mode bone thermal index cranial thermal index area of active aperture derated rarefactional pressure ultrasonic power in scanned modes ultrasonic power passing through a one centimeter window derated ultrasonic power at axial distance z derated spatial peak temporal average intensity at axial distance z axial distance corresponding to the location of max min W 2 1 2 minimu
35. Probe Main Menu with One Linear Probe on page 3 12 2 8 3 Probe Connection To connect or change a LINEAR CURVE PROBE insert the probe connector cable side down into the probe socket Rotate the connector lock handle 1 4 turn clockwise to lock the connector in place Figure 2 7 Connecting a Linear Curve Probe 10 12 01 INSTALLATION 2 13 disconnect probe rotate the lock handle 1 4 turn counter clockwise and pull the probe con nector away from the socket FAM V ccm Figure 2 8 Disconnecting a Linear Curve Probe To connect a SECTOR PENCIL PROBE align the red point side up and push the probe connec tor in the socket Figure 2 9 Connecting a Mechanical Probe UN Never connect or disconnect probe in live mode When system operates in live mode press the FREEZE key before connecting or disconnecting probe 2 14 SIGMA 110 SIGMA 330 10 12 01 2 9 Connection of Peripherals 2 9 1 Electrical safety with peripherals The peripherals should be marked with CE identification mark and be in compliance with IEC 950 or IEC 601 1 Standards 2 9 1 1 SIGMA 330 Excellence a All equipments printers video recorders external TV monitors and other peripherals should be connected to the three isolated outputs provided by the system or powered through a medical grade isolating transformer when the system includes more than three peripherals or their total consumption exceeds 340 VA AN Never co
36. 4 KONTRON M DICAL 1 3 5 Rear Panel 1 3 5 1 gr m L nllo gt SIGMA 330 Expert Rear Panel Fuses Electronic cabinet top part Switch ON OFF Electronic cabinet top part Mains plug Electronic cabinet top part Equalization potential terminal Chassis Ground Probe holder Guide for probe cable Handle Connectors for Linear Curved Probes Fuses SIGMA 110 330 cart bottom part Switch ON OFF SIGMA 110 330 cart bottom part Mains plug SIGMA 110 330 cart bottom part Equalization potential terminal Chassis Ground Equalization potential terminal Chassis Ground Connector panel Connector for Doppler Pencil Probes Receptacle for bottle of gel Connectors for Annular Sector Probes Air filter grid Identification labels at the top CE mark model reference serial number revision number at the bottom model reference serial number Output power 3 outlets for peripherals see Chapter 2 7 2 Output Power Source on page 2 11 1 22 SIGMA 110 SIGMA 330 15 10 01 it x Figure 1 10 SIGMA 330 Expert rear panel 15 10 01 INSTRUMENT DESCRIPTION M 4 KONTRON M DICAL 1 3 5 2 SIGMA 330 Excellence Rear Panel So E Se re er Cs Ce 4 ON OAR WN H OO Fuses Electronic cabinet top part Switch ON OFF
37. Dim of Aaprt lt 0 90 PD msec 1 99 6 PRF Hz S Pr PIlmax MPa deq QPllmay cm Len E IpA 3Mlmax W cm depth cm 3 Doppler frequency MHz 4 9 color depth min color angle min resolution med wall filter max energy dB 0 application 2 velocity range Hz 250 steering angle degrees 0 Notes a This index is not required for this operating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is not reported for the reason listed 7 132 SIGMA 110 SIGMA 330 15 10 01 not reported for the reason listed 15 10 01 APPENDICES MEDICAL Transducer Model 6 5 MC Operating Mode B mode TIS TIB TIC Index Label MI MEM Il saa eee Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value 1 5 a Pr3 3 0 g Wo mW min of W 3 z4 3 21 1 mW 21 cm A 25 cm 2 Zp cm 2 00 deq Zsp cm gt fe MHz
38. Overall gain is controlled by rotating the uppermost knob on the right side of the keyboard 32 positions are available Slope is controlled by using 5 rectilinear potentiometers on the top right of the keyboard 10 12 01 OPERATING INSTRUCTIONS 3 33 4 KONTRON M DICAL 3 7 3 PW Doppler SIGMA 110 and SIGMA 330 can perform Pulse Wave Doppler PW if Doppler option is installed Press PW key to select PW mode 3 34 1 The first time that you press the PW key you enter PW mode 2D PW is displayed The marker and the gate are displayed on the 2D image The trackball allows the user to move the marker on the image and to slide the gate on the marker to reach the required area If CFM option is installed SIGMA 330 in CFM PW mode the PW gate never exits the CFM window region of interest So moving the PW gate moves also the CFM window Set the PW line to the desired position When releasing the trackball the 2D image is automatically frozen and the PW mode becomes active If the PW line is repositioned using the trackball the 2D image will get unfrozen again The 2D image is refreshed at the end of each PW sweep The Refresh option can be enabled or disabled in the Preferences Menu SET UP gt Prefs gt Display gt Refr ON OFF If the user want to get the 2D image active without changing again to PW press the SELECT key To restart the automatically changing between 2D and PW press the SELECT key again Press
39. Turbulence on off Colour invert Chroma maps for optimum rendering of 2D echo structures Up to 64 frames cine memory ACOUSTIC OUTPUT Fulfils acoustic output display standard Complies with FDA acoustic output limits Automatic power output adjustment versus medical application for optimal Doppler formance ALARA e User selectable Doppler transmit power attenuation 8 positions between 0 dB and 21 dB 1 8 6 3D Imaging 2 highly intuitive user interface packages a 3D Fetal View 2D reconstruction a 3D Vascular View 2D and reconstruction Quick and easy 3D acquisition 1 SIGMA 330 Excellence only 1 58 SIGMA 110 SIGMA 330 15 10 01 Instantaneous multiplanar 3D reconstruction MPR 3D application specific rendering algorithms 3D segmentation tools advanced filter operations Image export to standard PC file format bmp and avi Digital archiving 1 8 7 Digital Archiving KIPRISM Digital archiving on Memory Card up to 32 images on 4 megabytes memory card up to 64 images on 8 megabytes memory card Transfer on Personal Computer via memory card PCMCIA standard DOS format Images in PCX format report in TXT format Up to 15000 color images per archiving media 640 MB DICOM 3 0 compatible with PACS option 1 88 ECG Module option FORMATS for all single or dual screen formats INPUT solated input type CF Defibrillator proof IEC 60
40. 1 Press ID key to display the Patient information sheet 2 Select New Patient to erase all patient information 3 Enter information concerning the new patient with the alphanumeric keyboard To enter text Move the cursor on the area to be filled in with the trackball the selected zone is high lighted Enter the characters End with ENTER key 3 15 3 Biometry Patient Study The Biometry patient study is made of measurements and calculations according to medical applications The different biometry pages have the following arrangement a At the top of the page the patient and laboratory information is displayed and can be mod ified directly The patient identification page will be automatically updated according to this modification When some modifications are made from the Patient Identification page the information displayed on the biometry page is updated a The second part of this page contains the different biometry calculation medical applica tion dependent a The third part contains the different tools icons Remark an inverted video icon means that it is selected The cursor can be moved with the trackball When the cursor is over a valid measurement field the selected field is displayed in inverted video To select the current measurement the user press on the SET key or ENTER key By selecting the REPORT icon the user displays the printable report of his measurement The TRASH icon is used t
41. 1 SIGMA 330 Excellence only 15 10 01 INSTRUMENT DESCRIPTION 1 53 CW display modes Quasi Duplex 2D CW 2D 50 screen CW 50 screen 2Di icon CW PW display modes Quasi Duplex 2D PW 2D 50 screen PW 50 screen 2Di icon PW CFM display modes Single CFM Quasi Duplex CFM PW CFM 50 screen PW 50 screen CFMi icon PW Colorised 2D TM PW amp CW mode display MONITOR e Colour monitor 10 diagonal 640 x 480 pixels resolution PAL NTSC compatible Direct management of brightness and contrast includes loudspeakers and control knob for volume LCD flat panel colour monitor e 15 diagonal 800 x 600 pixels resolution KE YBOARD Six languages English French German Italian Spanish and Russian Cyrillic Backlightening of all keys and knobs Ten software controlled function keys for menu selection Full alphanumeric capabilities B W and colour video printer remote control Trackball for TM CW PW line steering PW gate positioning CFM colour window resiz ing and positioning focus point setting annotation positioning measurements and cine mode review Layout removable for cleaning operation Trackball removable for cleaning operation INFRARED REMOTE CONTROL Ensure system control in any inadequate examination condition Allow the remote control for scanning parameters freeze and image printing Dedicated place on keyboard SCREEN LAYOUT
42. 1 cm TIZ em EAREA2 cm2 RES IND PUL IND PT TAMX m s VELs m s VELd m s EVELs VELd RI VELs m s 5 S VEI V V Velocity before or after the stenosis m s 7 31 Vascular Volume cm3 E 2 2 Volume Flow MVI Mean Velocity Integral in cm Time Average Velocity in m s Diam Diameter of the vessel in cm Blood Flow I mn 2 3 Spectral Broadening Index VTI Velocity Time Integral cm Time Average Maximum Velocity m s Mean Velocity PkV Peak Velocity in m s MVI Mean Velocity Integral in cm Time Average Velocity in m s SBI Spectral Broadening Index E 2 4 Cardiac Output Velocity Time Integral in cm Diam Diameter of the vessel in cm ASV Stroke Volume millilitres ASI Stroke Volume Index in millilitres per square meters Cardiac Output litres per minute Cardiac Output Index in litres minute per square meters E 2 5 Frequency Freq Doppler frequency shift in kHz E 2 6 Heart Rate SP or TM measurement HR Measured Heart rate in beats per minutes This field is used for the computation of the aortic valve study sheet E 2 7 Continuity Equations Diam1 Diameter 1 in cm AREA1 Area 1 cm2 Vel1 Velocity 1 in m s Vel2 Velocity 2 in m s AEAREA2 Area 2 with the Velocity in cm2 VTI1 Vel
43. 15 10 01 TROUBLESHOOTING 5 19 AVA KONTRON MEDICAL If the problem persists the user should inform the service team 5 5 9 Error 8 Invalid flash card type The current plugged flashcard is not recognised by the system The user should use a recom mended flashcard see Chapter 6 3 Accessories on page 6 5 5 5 10 Error 9 Ob Gyn restore error When restoring users preferences from flashcard the compliance of the restored data is checked In case of incompatibility inconsistent values restored the following message is dis played Error 9 Some Ob Gyn user s preferences are no more valid Restoring default values ox 5 5 11 Error 10 Flashcard not correctly formatted The SRAM format failed or there is a problem with the current SRAM archive Re format SRAM If problem persists SRAM is broken and should be changed Error 10 Flashcard is not correctly formatted 9 5 5 12 Error 11 Internal Communication Fatal error Internal communication error happens when the host does not receive message acknowledge ment from one of the DSPs After a time out the internal communication error message is dis played To acknowledge this message the user presses on any key and a message informs the user that the system will be powered off This error can happen when one of the DSPs has been reset due to software or hardware prob lems If this problem persists the user should call the service team
44. K 4 3 Foetal information Description SIGMA SonoWin Chapter Number of pregnancies GRAVIDITAS GRAV Patient data Number of birthes having reached time Term TERM Patient data Number of premature birthes Prema PREM Patient data Number of abortion Abortion ABORT Patient data Number of alive infant at birth Living LIV Patient data 2 ns CARDIAC Foetal Cardiac Activity ACTIVITY card Act Ob Fet 1 FOETAL MOVE Foetal Movement MENT MOVE Ob Fet 1 4 FOETAL Foetal Breathing BREATHING BREATH Ob Fet 1 Foetal Gender GENDER SEX Ob Fet 1 Foetal Presentation Hacc PRES Ob Fet 1 K 5 Radiology Study K 5 1 Description Volumes In Abdo 2D Studies Sono Win Chapter Distance 1 Tumor1 L Tumor2 L Tumor1 L Tumor2 L Abdomen Abdomen Small Parts Mamma Small Parts Mamma Distance 2 1 2 1 H 2 Abdomen Abdomen Small Parts Mamma Small Parts Mamma Distance 3 Tumor1 W Tumor2 W Tumor1 W Tumor2 W Abdomen Abdomen Small Parts Mamma Small Parts Mamma Volume K 5 2 Cardiac Outputs Description Tumor1 V Tumor2 V Tumor1 V Tumor1 V Sono Win Abdomen Abdomen Small Parts Mamma Small Parts Mamma Chapter Diameter of the vessel Card D Mitral Valve K 5 3 Continuity Equation 7 108 Description Sono Win
45. Sound velocity M When the user selects the USER item in the setup sheet this page is displayed The user can here enter his own curve The default sound velocity is set to 1540 m s reference value The user can enter a different value In this case the system automatically performs a ratio between the reference value and the user velocity before computing the interpolation If he presses the icon his curve is drawn on screen Note the week and uncertainty values must be entered in week as a floating value 3 weeks and 2 days 3 3 weeks 15 10 01 APPENDICES 7 47 H 4 KONTRON MEDICAL F6 Curve View When the user presses on the icon from one of the previous screens while meas urement field BPD FML or a gestational curve Bessis BPD group is highlighted the corresponding curve is drawn on the screen Others informations are also displayed as the measured length the NWA the age 14 01 98 08 30 31 BPD from Hadlock Length cm 26 8 Age 7 wk5d 2d NWA 7 5 wk 2 4 6 8 10 le L L L LL point is displayed on the curve graph This point matches the estimated information Age length if the NWA is lower than 15 weeks When NWA is equal or greater than 15 weeks the displayed point matches the NWA length information 7 48 SIGMA 110 SIGMA 330 15 10 01 4 KONTRO MEDICAL Appendix G Reference Tables for Ob Gyn G 1 Biparietal Diameter BPD G
46. The SIGMA 110 330 does not permit composite modes two modes produced at the same time However two modes can be made sequentially and then displayed next to each other on the same screen If two modes are displayed together this is called a double pad mode If only one is displayed it is called a single pad mode 15 10 01 GENERAL INFORMATION XV KONTRON AVA HAN MEDICAL These all real time displays However image be frozen at a particular point in time to produce a static display so that it may be studied in more detail later Imaging modes are explained in more detail in Chapter 3 7 Major Modes on page 3 25 The following table lists the SIGMA 110 330 probes and their intended clinical use Nominal Frequency PROBE MHz APPLICATIONS PROBE TYPE Convex Linear Probes 3 5 MHz CV 3 5 Abdominal Ob Gyn 2D TM PW CFM Cardiology Transcranial 2D TM PW CFM 3 5 MHz MC 3 5 Abdominal Vascular Angiology Pediatrics Cardiology 2D TM PW CFM Vascular Angiology 6 5 MHz MC Probes Abdominal Obstetrics 2D TM PW CFM Pediatrics Perivascular Pediatrics Perivascular 2D TM PW CFM Small Parts Pediatrics Perivascular 2D TM PW CFM Small Parts 5 0 MHz LV 7 5 MHz LV 7 5 MHz LVS Endocavitarian Probes 6 5 MHz EV 6 5 Ob Gyn Urology 2D TM PW Endorectal multiplane for 2D TM PW Urology 6 5 MHz VMC 6 5 Ob Gyn Urology 2D TM PW CFM Annular
47. XX ON Power OFF Power AC line input Protective earth ground Equalization potential terminal Type CF isolated E C G input defibrillator proof IEC 601 1 Type B equipment IEC 601 1 This symbol generally means Attention Please consult the equip ment documentation carefully before using any function labelled with this symbol gt gt 2 0 SIGMA 110 SIGMA 330 15 10 01 11 2 2 Environmental Safety Electro Magnetic Compatbility This system complies with the EN60601 1 2 Electro Magnetic Compatibility It is a Class B device Ultrasound units are designed to receive radio frequency RF energy and are therefore sus ceptible to other RF sources As an example other medical devices information technology products or TV Radio transmitters may all cause interference with the ultrasound system In the presence of RF interference the physician must evaluate the image degradation and its diagnostic impact Electrostatic discharge ESD An electrostatic discharge is a short transient current flow It may happen if electrostatically charged people touches a part of ultrasound system ESD may causes white or black dots in 2D or TM mode coloured dots in CFM and can be heard or seen as dots in Doppler mode The effects created by ESD are not at all correlated with the ultrasound information There fore they may be well differentiated from the true ultrasound echo
48. measurement be inserted the PI fields RI value is updated A RI measurement can be inserted in the RI field only 1 2 2 3 Speed and Frequency A speed measurement can be inserted in a frequency field and conversely A speed ratio measurement can be inserted in a speed or in a frequency field L2 2 4 Heart Rate and Time A time measurement can be inserted in a heart rate field and conversely A time ratio measurement can be inserted in a time or in a heart rate field 12 2 5 Area Measurement Both area and ellipse measurement can be inserted in the relevant report fields An Area ratio measurement can be inserted in both area and ellipse fields 12 2 6 Left Ventricle Study Both abbreviate and full version of the left ventricle TM measurement can be inserted in the rele vant report fields Only the available data will be displayed for the abbreviate measurement 1227 Automatic Integral Both manual and automatic integral can be inserted in the relevant report fields 1 2 2 8 Hip Angle This measurement cannot be imported because it is not available in the measurement menu 7 92 SIGMA 110 SIGMA 330 15 10 01 Appendix J Print Preview J 1 Edit the Printable Report To edit the printable report the user must press on the icon The print preview is displayed according to the following template 14 02 01 08 30 31 Measurement Results Page 2 3 L
49. wall filter off 0 dB application Vasc velocity range kHz 250 steering angle degrees 0 Notes a This index is not required for this operating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is not reported for the reason listed 15 10 01 APPENDICES 7 123 4 KONTRON MEDICAL Transducer Model 6 5 MHz VMC Operating Mode Color Flow Doppler TIS TIB TIC non scan Index Label MI non Sean Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value a 15 b Pr3 MPa 2 Wo4 mW 43 6 min of W 3 z1 3 21 1 mW G7 cm aM 25 em 2 Zsp cm 9 deq Zsp cm 2 fc MHz 6 13 lize 0 67 Dim of Aaprt lt 0 65 PD msec 1 40 6 PRF Hz S Pr Pllmax MPa deq QPllmay cm BOE FL cm 4 06 Len 8 FL om 406 IpA 3Mlmax W cm depth cm 6 Doppler frequency MHz 6 1 color depth min _ color angle min g resolution me
50. Cardiac Output in litres per minute gt Cardiac Output Index in litres minute per square meter gt H R Ratio Left Ventricular Wall diastole on Left Ventricle Radius diastole D 1 1 2 Ventricle Study Simpson 1 Short Axis Area 1 at Diastole cm2 SAA2d Short Axis Area 2 at Diastole in cm2 LALd Long Axis Length at Diastole in cm 5 15 Short Axis Area 1 at Systole cm2 SAA2s Short Axis Area 2 at Systole in cm2 LALs Long Axis Length at Systole in cm gt VOLd Diastolic Volume in cm3 gt VOLs Systolic Volume cm3 gt EF Ejection Fraction in percent gt CO Cardiac Output in litres per minute gt Cl Cardiac Index in litres per minute per square meters gt SV Stroke Volume in millilitres gt 5 Stroke Index in millilitres D 1 1 3 Heart Rate TM and SP Measurement HR Heart rate in beats per minutes measured on Left Ventricle This field is used for the computation of the left ventricle study sheet D 1 2 Equations D 1 2 1 General Information Body Surface Area in m2 BSA from Dubois and DuboisW weight in kg BSA D 71 84 10 25 9725 rz weight in kg height in cm 15 10 01 APPENDICES 7 13 AVA KONTRON MEDICAL D 1 2 2 Left Ventricle Study a 2D study e End Diastolic Volume in cm3 VOLd VOLd D BLAA LAAd LALd LAAd Long Axis Area at diastole in cm2 LALd Long Axis Length at diastole in cm End Systolic Volume i
51. Description 14 01 98 08 30 31 LAB 4 4 4 NAME ee EXAM Nieeeee SEX H 000cm W 000 0kg AGE Oy BSA Om2 HR 000b mn VASCULAR STUDIES STENOSIS PERCENTAGE Vell m s Vel2 m s ESS 5 STENOSIS INDEX cm TAMX m s PkV m s RESTI VOLUME 1 2 cm cm EV cm3 VOLUME FLOW cm TAV m s Diam cm 1 mn _ SPEC INDEX cm CARDIAC OUTPUT cm Diam cm ESV ml ESI ml m2 ECO 1 mn ECI 1 mn m2 HEART RATE HR b mn FREQUENCY Freq kHz E 2 Stenosis Percentage Vel1 Vel2 AS Velocity on the stenosis in m s Stenosis in percentage a Stenosis Index Time Average Maximum Velocity in m s VTI Velocity Time Integral cm TAMX PkV Peak Velocity in m s ASTI Stenosis Index E 2 1 Volume 1 Distance 1 cm d2 Distance 2 in cm d3 Distance 3 in cm 15 10 01 APPENDICES CONTINUITY EQUATION Diaml1 cm 1 cm2 Vell m s 12 Vel2 m s 2 cm2
52. H Czempiel Sonographie und Szintigraphie der Schilddr se HIP angles e Alpha angle The Alpha Angle is the angle formed by the Baseline and the Alphaline Type 6 if Alpha gt 5 7 if Alpha gt 98 Alpha lt 60 Type Alpha lt 438 HH Type of the Alpha angle Beta angle The Beta Angle is the angle formed by the Baseline and the Betaline Type 6 if Beta lt lt lt 7 if Beta2 55 and Beta lt 77 Type gli Beta 77 Hi Type t strype of the Beta Angle 15 10 01 APPENDICES 7 87 7 88 This page is intentionally left blank SIGMA 110 SIGMA 330 15 10 01 4 HA MEDICAL Appendix Measurement Interface A report sheet is a collection of fields ordered by function Mitral Valve Pulmonary Artery see screens description above The user can fill the report in two ways the report being displayed the user activates a measurement by clicking on a field e after having done a measurement the user can insert it in the report I 1 Doing a Measurement from Report Press the REPORT key to display a report sheet on screen 1 1 1 Operating Mode To make a measurement the user selects a main field by pointing it with the report cursor If the measurement is possible to do the pointed field highlights To start the related measurement the user clicks on the CURSOR SET keyboard key Then the ultrasound screen appears and the user starts the measuremen
53. Option Option Option Option Option 2 E lt a 2 9 2 Time Renting Option Option Option Option Option EasyPrint Black amp White Option EasyPrint Color Option Option v USB Link Option Option Option v Integrated compact PC and Flat 15 LCD Monitor for PC 3D Fetal View M option 3D Vascular View option PACS SonoWinlite option PACS Sono Winbasic option KIPRISM Cardiology features9 Table 1 3 System configuration and options op data etc Requires Cine option is available Label displayed in the start up or system information screens Iris features include colour gamma curves Rainbow and colorised screen layout measurement technical Spectral Doppler option includes PW CW Cine review Angio package and VMean VMax traces Picture Archiving and Communication Systems Please contact your local dealer for more information The complete features of Digital Archiving are obtained with Cine option Without Cine only the Store feature g Cardiology includes cardiology formats and setups biometry and measurements display that requires ECG module 1 6 SIGMA 110 SIGMA 330 15 10 01 1 3 Physical Description The basic SIGMA 110 330 is a transportable Ultrasound unit which includes the following sub assemblies Electronic cabinet con
54. Press Load SETUP F1 function key to select a dedicated setup of the current probe The System displays only the setups dedicated to the current probe including the Factory Set ups The Factory setups are always displayed after the user setups User setups are displayed in upper case and factory setups in lower case At most 20 user setups can be defined for all probes If more than 5 setups exist for the current probe a second page is added to the menu each setup page is accessed by using PREVIOUS lt or NEXT gt key page 1 USER USER USER USER Radio SETUP 1 SETUP 2 SETUP JSETUP 4 gt 3 6 3 Saving a Setup The user can save more than one setup for each probe and up to 20 setups for all probes To save a Setup 1 Press SETUP key to enter SETUP menu 10 12 01 OPERATING INSTRUCTIONS 3 13 2 Press Save Setup F2 3 Press New Setup F1 USER USER USER na SETUP 1 SETUP 2 SETUP SS 4 Enter the new setup name using the alphanumeric keyboard 5 Validate with RETURN key The sequence can be aborted at any time using the ESC key A new user setup has been created and stored in the system It appears in the setup menu Press ESC key to return to previous menu For renaming a setup the user must select the setup and save it again on itself For saving a new name is always requested 3 6 4 Deleting a Setup To delete a User Setup 1 Press Delete Setup F3 The Delete Setup Menu displays all user setups st
55. Software performs checking of measurements for proper range before displaying results Out of range measurement result The out of range result is displayed with question marks or sharp marks 1D BDP 11 5 mm EFA ar pistance BPD HC a THD Hul In this case the user restarts the current measurement to valid result denominator equal to 0 or too high measurement result Out of range Ob Gyn biometry result The current measurement result is out of range for the foetal age computation Value is out of limits Limits from 4 2 to 77 8 mm In this case the user restarts the current measurement to have valid result Invalid biometry result An invalid result negative computed mass invalid date is displayed as or according to the result type 5 3 2 2 Other Cases When restoring users preferences from flash card the compliance of the restored data is checked In case of incompatibility inconsistent values restored the following message is dis played 15 10 01 TROUBLESHOOTING 5 7 Some Ob Gyn user s preferences are no more valid Restoring default values 5 3 3 Transmit Voltage Indicator This symbol message TVI warns the user that the Transmit High Voltage for probes is out of range If the message persists contact your local service representative In live mode the s
56. This index is not required for this operating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is 7 125 4 KONTRON MEDICAL Transducer Model 3 5 MC Operating Mode M mode TIS TIB TIC Index Label MI PAPER Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value a lt 1 0 1 7 b Pr 3 MPa 2 Wo mW 39 4 min of W 3 4 3 21 mW 21 cm A bp Zsp cm 3 62 8 deq Zsp cm 0 33 4106 MHz 2 40 lize 1 09 Dim of Aaprt lt 1 20 PD msec 0 84 6 PRF Hz p Pllmax MPa 5 deq Pllmax 0 33 s F L th FL cm ocal Len E FL IpA 30MImax W cm depth cm 24 frequency f f f focus cm 3 Notes a This index is not required for this operating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate f
57. W cm application Vasc Vasc Doppler frequency MHz 8 8 gate size mm 8 8 velocity range kHz 3 2 3 2 energy dB 0 0 Notes a This index is not required for this operating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is not reported for the reason listed 15 10 01 APPENDICES 7 119 4 KONTRON MEDICAL Transducer Model 2 MHz TCD Operating Mode PW mode TIS TIB TIC non scan Index Label MI non Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value a lt 1 0 2 6 2 8 Pr 3 MPa 2 Wo mW 69 0 69 0 E min of W 3 4 Ira 3 z4 mW 21 cm A em 7 Zsp cm 3 85 8 deq Zsp cm 0 35 fc MHz 2 04 2 04 lize 1 5 1 5 Dim of Aaprt lt 1 5 1 5 PD msec 10 0 10 0 6 PRF Hz P Pllmax MPa 5 deq Pllmax 0 34 BOE FLy cm 4 20 ocal Len E d FL em 4 20 Ipa 3 Mlimax W cm application Vasc Vasc amp Doppler frequency MHz 2 2 gate size mm
58. and intensity level moreover for each mode a number of parameters will indirectly affect the transmitted field The SIGMA 110 330 allows the user to set the transmit focal point which will affect the indices by varying the beam profile Generally higher will occur with farer focal points If more than one transmit focal point is activated MI values will correspond to the zone with the largest value In TM mode the transmitted field is only affected by the transmit focal point and the frequency If M Mode is displayed with a 2D and the 2D is updated the system may shows always the index for the active mode MI for 2D TI for TM mode CFM The TI may be increased by any control which increases the system frame rate reducing the CFM window size increasing the CFM PRF Another variable factor is the CFM frequency the outcome in terms of transmitted field is mar ginal and largely unpredictable Pulsed Wave Doppler In PW the transmit energy is adjusted automatically when changing gatesize or PRF to be con stant Therefore the TI is constant for all settings of gatesize and PRF The only variable factor is the Doppler frequency the outcome in terms of transmitted field is marginal and largely unpre dictable Continuous Wave Doppler In CW the only variable factor is the Doppler frequency Most probes provide Doppler at more than one frequency the outcome in terms of transmitted field is marginal and largely
59. centre Use the arrows for moving in the four directions and press the button for validating the operation The keys PRINT TM 2D SELECT CFM PW CW and FREEZE access directly to the corre sponding functions described in Chapter 1 4 system Controlsblon page 1 28 The Remote Control Unit is powered by two 1 5 V batteries see Chapter 6 3 Accessories on page 6 5 for ordering 1 33 TV Monitor 1 3 31 General SIGMA 110 units are equipped with a high quality 10 Black amp White monitor to display images and information SIGMA 330 units are equipped with a high quality 10 colour monitor to display images and infor mation The monitor is integrated into the instrument housing 1 3 3 2 Controls If the image is not satisfactory check whether all controls are in the correct position for an opti mum adjustment The location of the controls is described in figure 1 6 SIGMA 110 Light SIGMA 110 Master and SIGMA 330 Master front view on page 1 17 15 10 01 INSTRUMENT DESCRIPTION 1 15 1 16 This page is intentionally left blank SIGMA 110 SIGMA 330 15 10 01 1 3 4 Front Panel 1 3 41 SIGMA 110 Light Master and SIGMA 330 Master Front View The following items are shown in figure 1 6 SIGMA 110 Light SIGMA 110 Master and SIGMA 330 Master front view on page 1 17 7 8 9 B GL c Audio volume adjustment Brightness adjustment for video screen Contrast adjustment for video screen Loudspea
60. for SIGMA 330 Master 484 164 Memory card label DOC31001EN Operator Manual English according to system language 462 489 Medical Ultrasound Safety Guide for US only DOC31001FR Operator Manual French according to system language o DOC31001GE Operator Manual German according to system language DOC31001IT Operator Manual Italian according to system language o DOC31001SP Operator Manual Spanish according to system language or or or o DOC31001CY Operator Manual Russian Cyrillic according to system language 483 184 Remote control Unit English according to system language 483 176 Remote control Unit French according to system language o o 483 168 Remote control Unit German according to system language 483 141 Remote control Unit Italian according to system language 483 133 Remote control Unit Spanish according to system language o 483 125 Remote control Unit Cyrillic according to system language 524 204 Fuse 5x 20mm T2A 717 150 Fuse 5 x 20 mm T 4 A according to line voltage 487 090 Notice for NTSC fuses 481 033 Remote control cable for Video printer 862 169 Coaxial cable 75 BNC BNC L 2 m 487 163 USB cable A BM M 15 Pts L 1 8 471 059 Air filter 426 016 Quality Control form Table 2 1 Supplying list for SIGM
61. neck testicles scrotal sac and breast Cardiology Application The probe applies ultrasound energy through the chest wall to obtain an image of the heart for purpose of assessing cardiac abnormalities In Doppler modes the probe applies energy through the chest wall to determine the velocity and direction of blood in the heart and in the vessels Obstetrics Fetal Application The probe applies ultrasound energy through a pregnant woman s abdomen to obtain an image of the fetus to detect structural abnormalities or to visualize and measure anatomical and physio logical parameters of the fetus for the purpose of assessing fetal growth In Doppler modes the probe applies energy through the patient abdomen to detect placental or fetal flow abnormalities Note The user should always follow the ALARA As Low As Reasonably Achievable principle but especially in Obstetrics Fetal applications Use the lowest amount of acoustic output power for the shortest duration of time to obtain the necessary clinical diagnostic informa tion Neonatology Application The probe applies ultrasound energy through the neonatal head fontanelles to visualize brain structures imaging or flow Doppler to detect structural or functional abnormalities WARNING This system is not to be used for transorbital or any other ophtalmic applica tions Transcranial Doppler The probe applies ultrasound energy through the adult patient skull to visualize f
62. not reported for the reason listed 15 10 01 APPENDICES 7 127 4 KONTRON MEDICAL Transducer Model 3 5 MC Operating Mode Color Flow Doppler TIS TIB TIC non scan Index Label MI non Sean Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value a 1 5 Pr3 MPa 2 Wo4 mW 100 3 min of W 3 z1 3 21 1 mW 21 z A 2 2 zm E Zsp cm 5 9 deq Zsp cm 2 Gg fe MHz 3 05 P lize x cm 1 09 Dim of Aaprt lt cm 1 20 PD msec 2 95 6 PRF Hz S Pr PIlmax MPa deq QPllmay cm Len 8 3 FLy 508 IpA 3Mlmax W cm depth cm 5 Doppler frequency MHz 3 1 color depth min _ color angle min g resolution hi 5 wall filter max 0 application Vasc velocity range Hz 250 steering angle degrees 0 Notes a This index is not required for this operating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is not reported for
63. use the trackball If the user unselects the image labelled 2 the thumbnail page is updated as shown below 19 11 00 10 53 35 SIMPSON Left Ventricle p Delete Cancel Undo Image Print gt a To print the selected images press on PRINT2 Note that the image title is always printed when available Be careful do not remove the memory card during this process otherwise the print process will be cancelled 10 12 01 OPERATING INSTRUCTIONS 3 97 AVA KONTRON MEDICAL 3 17 1 2 Print Deletion The Delete All Images menu item is changed into Cancel Print during the print process When this key is selected a confirmation dialogue box is displayed first The print is cancelled if the user validates it Do you want to cancel the printing process Yes Moreover if the flashcard is removed while the print is in progress the print is automatically can celled and an error message is displayed See Chapter 5 5 17 Error 16 Flashcard removed while printing on page 5 21 3 17 2 Printing of Report Printing of Patient Report is available from the Report menu 3 98 SIGMA 110 SIGMA 330 10 12 01 3 18 USB LinkHA Option 3 18 1 Overview The USB Link option allows the connection of the ultrasound scanner to a computer and so extends the KIPRISM capabilities With USB Link the SRAM memory card is recognized by the computer as if it was a removable hard disk All the images
64. you enter CW mode 2D CW is displayed The CW line marker is displayed on the 2D image The trackball allows the user to move the marker on the image to reach the required area 2 Set the CW line to the desired position When releasing the trackball the 2D image is automatically frozen and the CW mode becomes active If the CW line is repositioned by the trackball the 2D image will get unfrozen again The 2D image is refreshed at the end of each CW sweep The Refresh function can be enabled or disabled in the Prefer ences Menu SET UP gt Prefs gt Display gt Refr ON OFF 3 If the user want to get the 2D image active without changing again to CW press the SELECT key To restart the automatically changing between 2D and CW press the SELECT key again 4 Press a second time the CW key to display a 2D icon CW format 10 12 01 OPERATING INSTRUCTIONS 3 39 H 4 KONTRON ME DICAL 3 74 1 CW Mode Selection NNNNNNANS 7774747 7472227 277777 4474477 722224 77742727 77777 2 77774 444 attt 99555555 NNNNNNNS 550905 777 oer 72 2774 JD 22242444444 Figure 3 6 CW Mode Selection 3 40 SIGMA 110 SIGMA 330 10 12 01 3 7 42 CW Live Menu If CW mode is active the following SP menu is displayed on the screen The 2D image is frozen or refreshed at the end of each SP sweep sweep venant gt Inv Freq o anote Ener
65. 1 focus zone Q Trigger This function enables ECG trigger s when ECG Option is installed See Chapter 3 16 ECG Option on page 3 95 a Gamma Eight compression curves 1 to 8 are selectable by using MP softpot The first six ones vary gradually from dark and soft image Number 1 to light and contrasted image Number 6 the numbers 7 and 8 are inverted Default Gamma setting is probe dependent a Smooth Four different to 3 settings of image filtering are selectable to improve image smooth ness and reduce noise level Smooth 0 without Smooth filtering Enhance This function offers the possibility to improve the image sharpening enhancement of ves sel wall and organ contour Enhancement increases from number 3 to 3 a Reject This function controls the dynamic range of the ultrasound echoes and allows a better dif ferentiation of tissues 10 12 01 OPERATING INSTRUCTIONS 3 29 H 4 TRON MEDICAL e Reject 0 maximum dynamic range soft image e Reject 3 maximum rejection more contrasted image Rainbow SIGMA 330 only This function controls the colorisation of the ultrasound image The MP softpot allows the selection of 8 sets of colour Rainb 0 to Rainb 7 The one selected is shown in the Techni cal Data Window Rainb 0 corresponds to black and white image display Rainb 1 to 7 cor respond to colorised image TIMI This feature displays hides the Thermal or Mechanical Indexes 3 7 1 3
66. 2 9 5 Connection of Colour Video Printer The colour video printer must be connected to the colour video output of the SIGMA 330 sys tems This configuration is recommended for the MITSUBISHI CP700E colour video printer Colour VIDEO PRINTER Figure 2 11 Colour Video Printer Connection 1 Reference 481 033 Remote control cable for Colour Video Printer 2 Reference 479 764 Signal cable for Colour Video Printer 10 12 01 INSTALLATION 2 19 AVA KONTRON MEDICAL 2 9 6 Video Recorder VCR SIGMA 110 and SIGMA 330 systems include a Super VHS interface which allows the user to perform high quality record with S VHS system Any PAL or NTSC compatible VCR s can be con nected to SIGMA 110 and SIGMA 330 The VCR output can be configured at the factory to either S VHS or VHS standard 2 9 6 1 S VHS VCR The system features one VCR socket for S VHS video input and output with sound gun a TTA CHR lt s 5 5 VCR Figure 2 12 Connection of S VHS VCR 1 Reference 481 076 integrated signal cable for S VHS VCR The recommended S VHS VCR is PANASONIC AG MD830E This recorder includes a S VHS AUTO OFF selector on its front panel Set this selector AUTO for S VHS operation To obtain the best performances use Super VHS Video Cassettes The switch MODE LOCK have to be set to OFF The switch Hi Fi NORM must be set to Hi Fi 2 20 SIGMA 110 SIGMA 330 10 12 01 2 9 6
67. 2 VHS VCR The system features one VCR socket for VHS video input and output with sound VHS VCR Figure 2 13 Connection of VHS VCR 1 Reference 487 252 integrated signal cable for VHS VCR 2 9 6 3 Black amp White VHS VCR A Black amp White VHS VCR can be connected to S VHS VCR output using an adapter Black amp White VHS to S VHS VCR ADAPTER Figure 2 14 Connection of VHS VCR on S VHS output 1 Reference 481 076 integrated signal cable for SVHS VCR 2 Reference 468 434 VHS to S VHS adapter 10 12 01 INSTALLATION 2 21 AVA KONTRON MEDICAL 2 9 7 ECG Module The optional ECG Module can be coupled to SIGMA 110 and SIGMA 330 systems via the COM1 port located on the rear connector panel The ECG Module includes an ECG signal amplifier for displaying the trace on the video screen and a QRS detector for synchronizing the 2D image The ECG Module is not intended for electrocardiography or monitoring use Nevertheless its isolated input is protected against the effects of a defibrillator and classified as Type CF Black Right Leg Yellow Left A ECG Module ee 483 281 Red Right Arm Figure 2 15 Connection of ECG Module The figure 2 15 shows the connection of the ECG Module to SIGMA 110 330 The patient cable must be connected to the patients right arm Red left arm Yellow and right leg Black by means of the included ECG electrode clamps or by clipping it to disposable ECG
68. 200 240 V T2A T6 3A 5x 20mm Table 2 5 Power Frequency rating for SIGMA 330 Expert Excellence RATED INPUT POWER RATED FREQUENCY 680 VA 110 127 V 50 amp 60 Hz 680 200 240 50 amp 60 Hz Table 2 6 Power Frequency rating for SIGMA 330 Expert Excellence 2 10 SIGMA 110 SIGMA 330 10 12 01 4 KONTRO MEDICAL The fuses located at the top part of the instrument are dedicated to electronic cabinet The bottom fuses located at the bottom are dedicated to the complete SIGMA 330 Expert and SIGMA 330 Excellence power supply including electronic cabinet and power output for peripher als See figure 1 10 SIGMA 330 Expert rear panel on page 1 23 to locate fuses 2 7 2 Output Power Source SIGMA 330 Expert and SIGMA 330 Excellence include three auxiliary mains outlets to supply some peripheral units such as VCR Printers and other peripherals plus another one to supply the Electronic Cabinet See Chapter III 2 1 Electrical Safety on page xix Power voltage supplied by the auxiliary mains is the same as local power line Before connecting a peripheral to the SIGMA 330 power output be sure that its voltage range corresponds to the local power line voltage and its consumption fits with the output rating for peripherals MAX CONTINUOUS OUTPUT RATING for PERIPHERALS 100 127 200 240 V 340 VA MAINS VOLTAGE Table 2 7 Ou
69. 4 CET 59 4 Wes 588 gt 0 6 Freq ps 1 Time Heart PI amp RI m Lew Ratio undo The Systolic velocity is displayed in cm s or m s The Diastolic velocity is displayed in cm s or m s 3 14 6 9 Pressure Half Time Measurement The Pressure Half Time is measured by setting two points like for the acceleration measure ment on the Doppler spectrum 1 Press F8 PHT to select pressure half time measurement 2 Use the trackball to move the first marker to the desired position 10 12 01 OPERATING INSTRUCTIONS 3 87 3 Press upper left SET key to fix the marker the second end marker is now available 4 Use the trackball to move the second marker to the desired position Press upper left SET key to fix the second marker The result is automatically displayed on the screen e 1 0 A 0 8 FC 0 6 0 4 6 0 2 E a oe i AA ky espa 6m 744 4 06 5 4 0 8 10 m s Freq VTl PI amp RI Ratio Undo Pressure Half Time is displayed in ms Peak Velocity is displayed in m s Acceleration is displayed m s 3 14 6 10 Ratio Measurement a On Speed measurement and on frequency measurement 1 0 0 8 TN 0 6 5 8 N 04 1 7 9 iN 02 i 0 Ts m 55584 5 22 GUN GSH Op 25 Tim 5 lt 4 PO Syd v Op
70. 485 012 485 195 485 365 485 543 485 713 SIGMA 330 Master 482 080 485 209 485 373 485 551 485 721 485 918 SIGMA 330 Expert 482 420 483 818 483 982 484 156 484 334 484 504 SIGMA 330 Excellence without frame grabber board 483680EN 483680FR 483680GE 483680IT 4836805 483680CY SIGMA 330 Excellence with frame grabber board 483400EN 483400FR 483400GE 483400IT 4834005 483400CY Table 1 2 Reference numbers of SIGMA 110 SIGMA 330 15 10 01 INSTRUMENT DESCRIPTION 1 5 4 KONTRON MEDICAL The following table summarizes the configurations of the SIGMA 110 SIGMA 330 models SIGMA 110 SIGMA 330 PRODUCT Light Master Expert Excellence w o FG with FG Start up label SIGMA 8 110 Light 110 330 330 Integrated Cart Bolero Cart Option Option Probes holder set Y v Handle Option Option Colour monitor Iris features Linear Convex probes Spectral Doppler Option Power Spectral Doppler Option Cine Option v ECG Option Option Remote Control Option v Footswitch Option Option Switchbox Option external Option external Repetition Monitor Option Option Option PCMCIA Memory Card Flash SRAM 4MB SRAM 4MB SRAM 4MB SRAM 4MB VHS option
71. 78373 PLAISIR CEDEX FRANCE Internet www kontronmedical com Apple Macintosh iMac MacOS FireWire are registered trademarks of Apple Computer Inc Intel Pentium and Pentium are registered trademarks of Intel Corporation Linux is a registered trademark of Linus Torvalds Matrox is a registered trademark of Matrox Electronic Systems Ltd Microsoft and Windows are registered trademarks of Microsoft Corporation USB is a registered trademark of USB Implementers Forum Inc SonoWin Sono and Sono Winbasic are registered trademarks of Meso 15 10 01 GENERAL INFORMATION iii H 4 KONTRON MEDICAL Il Quality Reliability and Safety This equipment has been designed with high standards of quality reliability and safety KON TRON MEDICAL SAS can however only accept the corresponding manufacturer s responsibility providing the following conditions are met Electrical installations of the room or building in which the equipment is to be used must comply with the relevant national regulations The equipment is used in accordance with the instructions for use provided by KONTRON MEDICAL SAS Opera tor manual All modifications and repairs to the equipment are carried out by authorized KON TRON MEDICAL personnel or their agents The equipment must comply with regulations specified in the Safety Informations section Your local KONTRON MEDICAL company or agent is To be filled by local KONTRON MEDICAL
72. Allow the remote control for scanning parameters freeze and image printing Dedicated place on keyboard SCREEN LAYOUT Patient identification field including patient name clinic name operator name time and date Technical data field showing all pertinent imaging parameters Measurement field displaying the last ten measurement results Menu field activated by the corresponding function key Freeze mode indicator Cine loop memory index option Annotation arrows and user defined annotations with trackball controlled positioning Image orientation indicator Over 51 body markers with scan plane indication Dot lines for TM CW PW beam orientation Real time ECG trace display Biopsy channel indication with automatic calibration of depth probe type left right guides and angle up down orientation SETTINGS Default settings related to the medical application and transducer for image quality opti mization User settings memorized in the system as well as on a flash card 15 10 01 INSTRUMENT DESCRIPTION 1 45 AVA KONTRON MEDICAL 1 7 2 2D B Mode SCANNING SECTOR e Angle 40 45 60 75 90 110 and 140 for Annular Sector Probe dependent e Angle 30 45 60 75 90 and 110 for Convex Array Probe dependent e Depth 2 cm to 24 cm up to 10 depths Probe dependent e Nominal frequency range 2 to 14 MHz Probe dependent FRAME RATE e Up to 200 fps probe and medical application dependent e D
73. CO Cardiac Output in litres per minute gt Cardiac Output Index litres minute per square meters D 3 2 2 Descending Aorta SP Measurement VTIs Velocity Time Integral at Systole in cm VTId Velocity Time Integral at Diastole in cm VTId VTIs Ratio Diastole VTI Systole D 3 2 3 Heart Rate TM or SP Measurement HR Heart Rate in beat per minute on aortic valve This field is used for the computation of the aortic valve study sheet 15 10 01 APPENDICES 7 23 AVA KONTRON MEDICAL D 3 3 Equations a SP study e Velocity Time Integral VTI in cm VEY Vj At D C v D 2 fo COSA Vi Velocity in m s during each Dt in s of measured spectral area Df Doppler frequency in Herz C Sound velocity 1540 m s fO Ultrasound frequency in Herz a Angle between the ultrasound beam and blood velocity e Pressure Time Integral in seconds per mmHg PTI PTI P Dav Pi Pressure in mmHg during each Dt in s of the velocity spectrum Computed from simplified Bernouilli equation V Velocity in m s Mean Gradient in mmHg MnG MnG D ET Time PTI Pressure Time Integral Time Duration flow in seconds Pressure Half Time in millisecond PHT PHT D PV a M PV Peak Velocity in metres per millisecond 5 Slope metres per square seconds Cardiac Output in litres per minute CO co DSV HR SV HR 1000 SV Stroke Volume in millilitres HR Heart Rate in bea
74. Duration flow in seconds Blood Flow using VMean BF TAV 60 E p BFD 1000 BF Blood Flow in l min TAV Time Average Velocity in cm s D Diameter of the vessel in cm E 3 8 Continuity Equation e Area in cm2 computed from 2D diameter AREA Di 2 AREAI pie Diam Diameter in cm e Area cm2 computed from velocities AREA2 AREA2 DAREAI Vell Vel2 Vel1 Velocity 1 in m s Vel2 Velocity 2 in m s 15 10 01 APPENDICES 7 35 AVA KONTRON MEDICAL e Area in cm2 computed from velocities time integral AREA2 VTI2 VTI Velocity Time Integral 1 in cm VTI2 Velocity Time Integral 2 in cm E 3 9 Resistance Index Pulsatility Index Time Average Maximum Velocity in metres per second TAMX TAMX D VT Time VTI Velocity Time Integral Time Duration flow in seconds Resistance Index from Pourcelot RI Vels Veld RHD ccv Vels Vels Velocity at systole m s Veld Velocity at diastole in m s Pulsatility Index Vels Veld p TAMX Vels Velocity at systole m s Veld Velocity at diastole in m s TAMX Time Average Maximum Velocity in m s 7 36 SIGMA 110 SIGMA 330 15 10 01 Appendix Ob Gyn Studies F 1 2D Sheet F 1 1 Description 14 03 01 08 30 31 1 66666 __ OB GYN STUDIE LM Meas cm CRL GES EHC AC ChD EFML AC BPD EFML BPD BOD OFD WEIGHT 9 HC g TAD AUA APD AEBD AC TH
75. Electronic cabinet top part Mains plug Electronic cabinet top part Equalization potential terminal Chassis Ground Probe holder Guide for probe cable Handle Connectors for Linear Curved Probes Fuses SIGMA 110 330 cart bottom part Switch ON OFF SIGMA 110 330 cart bottom part Mains plug SIGMA 110 330 cart bottom part Equalization potential terminal Chassis Ground Equalization potential terminal Chassis Ground Connector panel Connector for Doppler Pencil Probes Receptacle for bottle of gel Connectors for Annular Sector Probes Air filter grid Identification labels at the top CE mark model reference serial number revision number at the bottom model reference serial number Output power 3 outlets for peripherals see Chapter 2 7 2 Output Power Source on page 2 11 1 24 SIGMA 110 SIGMA 330 15 10 01 Figure 1 11 SIGMA 330 Excellence rear panel 15 10 01 INSTRUMENT DESCRIPTION 1 25 AVA KONTRON M DICAL 1 3 5 3 SIGMA 110 Light Master and SIGMA 330 Master Rear Panel por NERO act 10 11 12 Fuses see Chapter 2 7 1 Input Power Source on page 2 10 Switch ON OFF Mains plug Probe holder Bottle of gel receptacle Equalization potential terminal Chassis Ground Identification label CE mark model reference serial number revision number Connector for Linear Curved Probes Master Air filter grid Connectors for
76. Expert and SIGMA 330 Excellence The upper part Monitor is packed in a cardboard box Remove it carefully For SIGMA 330 Excellence the flat screen and micro computer are packed in a separate card board box Remove them carefully The instrument body Cart is packed into a wood crate Remove the top and side boards Remove the foam protecting the instrument Remove the instrument from the pallet 2 3 Checking the Instruments Identification The identification label with designation reference number and serial number is affixed to the rear panel see figure 1 10 SIGMA 330 Expert rear panel on page 1 23 figure 1 11 SIGMA 330 Excellence rear panel on page 1 25 and figure 1 12 SIGMA 110 Light Master and SIGMA 330 Master rear panel on page 1 26 10 12 01 INSTALLATION 2 3 AVA KONTRON HIN MEDICAL 2 4 Checking the Delivery Check the contents of the consignment with the delivery note that is supplied with each system If parts are missing or damaged inform your local KONTRON MEDICAL representative Following standard parts are supplied with the instrument For ordering optional accessories refer to Chapter 6 3 Accessories on page 6 5 Ref Designation 100 250 250 ml bottle of ultrasound gel 411 353 Power cable EURO D CEE 22 487 848 Power cable North American Hospital Grade for US 485 055 Memory card 4 MB PCMCIA for SIGMA 110 Light and Master 477 729 Memory card 4 MB SRAM PCMCIA
77. Parameters Images per page This parameter selects the number of images to be displayed on a page The size and the posi tion are optimized in order to maximize the image size Available values 1 2 3 4 5 and 6 images per page Default value 2 images per page 10 12 01 INSTALLATION 2 27 AVA KONTRON HIN MEDICAL The following page layouts are defined Mr Samuel JONES Andrews Hospital Mr Samuel JONES Andrews Hospital Mr Samuel JONES Andrews Hospital Image Title Image Title e Title Image Title TR Kontron Medical layout Kontron Medical layout2 Kontron Medical layout3 page 1 Mr Samuel JONES Andrews Hospital Mr Samuel JONES Andrews Hospital Mr Samuel JONES Andrews Hospital OON s Image Title Image Title h Image Title Image Title G gt p Image Title i Image Title Image Title 4 PN p N Image Title Image Title id E 4 Image Title Image Title Image Title Image Title Kontron Medical layout4 page 1 Kontron Medical layout5 page 1 Kontron Medical layout6 page 1 Figure 2 21 Predefined page layouts These layouts are available with both A4 and US letter formats A Image size 16 8 cm x 12 7 cm B Image size 11 2 cm x 8 5 cm C Image size 8 4 cm x 6 4
78. Ratio Und Ab LVSt Fu LVSt ndo Jase rows Delta Distance default selection i Time i SLOPE HeartRate Heart Rate Ab LVSt Abbreviated Left Ventricle Study Fu LVSt Full Left Ventricle Study Ratio Delta Delta 1 d1 d2 for distance Ratio A B for other meas i Undo 10 12 01 OPERATING INSTRUCTIONS 3 77 AVA KONTRON MEDICAL 3 14 5 1 Distance Technical Data 6K 7555 Distance Time Slope Rate ros pete Undo The TM distance measurement is made by setting two points on the image The two cursors used for this measurement can only be moved in the vertical way The distance between these points is computed according to the current image format depth and is displayed in millimetres on the right side of the screen 3 14 5 2 Time Technical Data S P pistance Time Slope Heart oe Ratio Undo The TM Time measurement is made by setting two lines on the image start and end line The time between these two lines is computed according to the current scrolling speed and is dis played in seconds on the right side of the screen 3 78 SIGMA 110 SIGMA 330 10 12 01 3 14 5 3 Slope Technical Data psance Slope ll Heart Rate Fws Undo The TM Slope measurement is made by setting two points on the image The slope betwee
79. T lt 555 1 0 8M 7 5 Freq VTI BORO PI amp RI RI Ratio Undo For the ratio on a Speed or Frequency measurement the result of the speed or fre quency and of their ratio is displayed a On Doppler Time measurement Refer to Chapter 3 14 5 6 TM Ratio or Delta Ratio on page 3 81 3 14 6 11 Acceleration Measurement The Acceleration is measured by setting two points on the Doppler spectrum The acceleration between these points is computed according to the current image format velocity and scrolling speed and is displayed in meter per square second on the right side of the screen 3 88 SIGMA 110 SIGMA 330 10 12 01 Gc obe 4 KONTRO MEDICAL Press F1 on menu page 2 Acceler to select acceleration measurement Use the trackball to move the first marker to the desired position Press upper left SET key to fix the marker the second end marker is now available Use the trackball to move the second marker to the desired position Press upper left SET key to fix the second marker The result is automatically displayed on the screen 1 0 0 8 0 6 0 4 0 2 N 0 0 2 gi 78 v47 04 gt 0 6 P EN EN LL L Lol Acceleration is displayed m s 3 14 6 12Mitral Valve Measurement The Mitral Valve Area is measured by setting two po
80. VMax or VMean will be drawn automat ically by moving the trackball to the right follows the blue points in a VMean integral measurement and the orange points in a VMax integral measurement 2 To finish the integral measurement the user will press on the Upper Left Set Key 3 By pressing on the VTI MVI key the following menu will be displayed when MVI is pressed the Auto Manual button is disabled EL E Lue For VTI the drawing mode defined in the preference menu is activated default VMax auto So in the preference menu an entry permits to choose between the automatic or manual VTI computation 4 fthe user agrees the default drawing mode he starts his measurement by setting the first integral point at the desired position by pressing the Upper Left Set Key If he wants to use another drawing mode he just presses on the Manual Auto key Remarks a During automatic VTI computation the user can switch to the manual mode by pressing on the Manual Auto key and return to the previous automatic mode by pressing on the same key auto manual toggle key on F1 a During automatic VTI MVI computation the user can erase a part of the current measure ment by pressing on the Backspace key on the right of the alphanumeric keyboard or on the F4 key same function as backspace or on the F5 key equivalent to 5 backspace or move the trackball from the right to the left a Manual integral measurement VTI only By choosing this mod
81. When working in non polluted environments the air filter must be replaced twice a year When working in very polluted environments it must be replaced every month It is mandatory to replace the air filter when the Warning 18 is displayed Note that a worn and cleaned filter will never be as efficient as a new one It is recommended to replace the filter by the KONTRON MEDICAL genuine part PN 471059 The air filter is located on the backside of the instrument To replace it Figure 4 5 Air filter replacement Pull on the air filter grid as shown on the figure 4 5 to remove it Remove the used filter Place the new one 4 8 SIGMA 110 SIGMA 330 10 12 01 Position back the air filter grid 4 3 1 2 Remote Control Unit The Remote Control Unit is powered by two LRO3 AAA MN 2400 batteries Replace batteries only with batteries of the same type 4 3 2 Manufacturer Maintenance A yearly maintenance visit is advisable It should be carried out by personnel authorized by the Manufacturer 10 12 01 MAINTENANCE 4 9 AVA KONTRON MEDICAL 4 4 Product Recycling and Disposal The SIGMA 110 and SIGMA 330 contains electronic boards batteries and tubes Before you dispose the system these boards batteries and tubes must be removed and dis carded according to local regulations or recycled where facilities exist Contact your local KON TRON MEDICAL company or agent for further informations For battery disposal contact
82. amp W for SIGMA 110 systems this option requires CINE Option a EasyPrint Color for SIGMA 330 systems The EasyPrint Options allow the user to print Patient Reports and ultrasound images The images must be previously saved on a memory card before printing The printing process is done while the system can continue to perform other tasks This allows the user to work during the images are printed 3 17 1 Printing of images 3 17 1 1 Selection of images for printing a Store the images to be printed on a memory card SRAM see Chapter 3 11 1 Image Storage and Freeze Menu on page 3 51 View the Panel of 16 images thumbnails see Chapter 3 11 2 Archive Display of Stored Images on page 3 52 MO MO M 10 53 35 SIMPSON Left Ventriclellil a Delete Del All Undo Image Images gt a Select each image to print with the trackball and by pressing the SELECT key the number of selected images is displayed over the thumbnail it defines also the position of the image on the printed page a You can also press directly on the PRINT2 key all the images from the current patient will be selected and printed 3 96 SIGMA 110 SIGMA 330 10 12 01 19 11 00 10 53 35 COL Y EXE SIMPSON Left Ventricle lil Delete Del All Undo Image Images gt a An image can be removed from the list at any time just press on the SELECT key again when it is highlighted
83. automatically modified Q PRF Auto Adjustment As above mentioned the CFM window position and size is limited by the PRF When the user wants to exceed this limit an auto adjustment will be performed the is set to the next available lower value The original value is restored as soon as the CFM window is moved to a suitable position 3 7 5 6 Trackball Assignment In CFM mode the trackball is assigned to different actions in live mode resizing of the CFM window positioning of the CFM window moving Cursor pointer 10 12 01 OPERATING INSTRUCTIONS 3 45 moving zoomed window zoomed CFM moving TM line CFM TM moving PW gate CFM PW in freeze mode moving Cine loop moving Cursor pointer moving magnified area 3 7 6 3D imaging This function uses the internal compact PC see Chapter 3 20 Integrated PC SIGMA 330 Excellence on page 3 110 a 3D FetalView IM for using this software module please consult its proper user manual 3D VascularView for using this software module please consult its proper user man ual 3 46 SIGMA 110 SIGMA 330 10 12 01 3 8 Print This function controls the Video Printer The user can select between 2 print keys a Press PRINT 1 function key to print a screen copy on the B amp W Video Printer Press PRINT 2 function key to print a screen copy on the Colour Printer or to store the image in the digital archive equivalent t
84. cm Font Available values Courier Times Univers Default value Times Print Borders This parameter displays a black border around each image Available values yes and no Default value yes Print Head Foot This parameter displays a header and a footer on each page Available values yes and no Default value yes Paper color 2 28 SIGMA 110 SIGMA 330 10 12 01 4 KONTRO MEDICAL This parameter selects the way the background has to be displayed The background can be dis played in white or as is i e as saved on the flash card Available values white and as is Default value white e Paper Size Available values A4 and US letter Default values A4 for PAL video systems and US letter for NTSC video systems Paper Available values plain glossy and transparency Default value plain Background process This parameter manages the print task If the user selects yes he can use the SIGMA normally but print process will take more time else the SIGMA is no more available during the printing Available values yes and no Default value yes Header amp Footer When Header amp Footer is pressed F2 key the following screen is displayed 14 09 00 08 30 31 HEADER HHEENTER IB GET 0 m Date and time ROW1 SLaboratory SOperator HbDateAndTime Laboratory ROW2 SPatientName 72
85. company or agent iv SIGMA 110 SIGMA 330 15 10 01 TABLE OF CONTENTS 10 12 01 SIGMA 110 SIGMA 330 10 12 01 l Copyright Il Quality Reliability and Safety Ill Intended Clinical Use and Safety Information IV Compliance with Standards 1 INSTRUMENT DESCRIPTION 1 1 1 2 1 3 14 1 5 1 6 1 7 10 12 01 Introduction SIGMA 110 330 Equipments Physical Description Electronic Cabinet Control Pariel TV 55 rd Front Pa el Rear Pariel 2 icd b ra bcd System Controls Alphanumeric Keys 1 3 1 1 3 2 1 3 3 1 3 4 1 3 5 1 4 1 1 4 2 1 4 8 Keys for Frozen Image Study WaACKDAl eH Screen Layout 1 4 4 1 5 1 Ultrasound Screen Layout eese Ed 1 5 3 Technical Data Display oii detiene ice een 1 5 T 2D Mod s oie outta 1 6 2 JMUIMOGOGS s iiie iet tate ies 1 6 3 CW and PW 1 6 44 SIGMA 110 Technical Specifications hx 1 7 2 2D 1 7 3 TM 1 7 4 Spectral Doppler Mode 1 7 5 Digital Archiving
86. field The three following fields are useful for obstetrician LMP Last Menstrual Period NWA Number of Weeks of Amenorrhea EBD Estimated Birth Date C 1 2 Equation Body Surface Area in m2 BSA from Dubois and Dubois BSA D 71 84 10 95 9725 W weight in kg H height in cm 7 8 SIGMA 110 SIGMA 330 15 10 01 2 Second Page If the user presses on the 5 icon of first patient information page the following sheet is displayed If the user presses the same icon from the second patient information page the first page is displayed again For more details on report menu see Appendix B Report Menu on page 7 5 14 02 01 08 30 31 PATIENT INFORMATION Page 2 REF PHYS REF PHYS Referring physician EXAMINATION REASONS TREATMENT COMMENTS 15 10 01 APPENDICES 7 9 7 10 This page is intentionally left blank SIGMA 110 SIGMA 330 15 10 01 Appendix D Cardiology Study The cardiology report sheets are ordered according to the studied function left ventricle mitral valve aortic valve right ventricle The following drawing locates the main studied functions AORTA PULMONIC J PULMONARY ARTERY AORTIC VALVE MITRAL VALVE TRICUSPID VALVE LEFT VENTRICLE Hereunder the functions and measurements available in the cardio study sheet are described 15 10 01 APPENDICES 7 11 H 4 KONTRON MEDICAL D 1 Left Ventri
87. for importing DICOM images a DICOM ext for exporting DICOM images Please contact your local KONTRON MEDICAL representative for more information 3 19 2 Start a Study The correct assignment of individual data to a particular patient is based on a patient ID This unique identification is entered in the host ultrasound device under the FOLDER field of the patient ID page The simplest way to set up a new patient is to always create a patient record in Sono Win first Then before starting a new study on the ultrasound device it is essential to press the New patient icon E this will reset all the biometry and patient fields and store the generated patient ID in the FOLDER N field The other patient data such as name date of birth etc are then automatically and correctly assigned in Sono Win and do not have to be entered again in the ultrasound device 3 104 SIGMA 110 SIGMA 330 10 12 01 3 19 3 Save images reports and patient information During an examination the operator can store patient data report and images on a formatted PCMCIA SRAM Images are stored when the Store key is pressed in any freeze menu Col T cci Gol me OFT Reports and patient information stored from any biometry page or from the patient ID page when the Store key is pressed 10 12 01 OPERATING INSTRUCTIONS 3 105 4 HA MEDICAL 3 1
88. gestational table and press F3 CURVE VIEW the corresponding curve is displayed 10 12 01 OPERATING INSTRUCTIONS 3 93 14 01 00 08 30 31 BPD from Hadlock cm 50 45 F 40 35 30 35 Length cm 26 8 ZO 20 Age 7 wk 5d fell P 2d iL a NWA 7 5 wk 5 EJ 0 0 2 4 6 8 10 The point displayed is obtained with the NWA according to the LMP and the value measured Its position compared to the reference curve gives an immediate indication of the fetus growth See OB GYN study sheet SETUP sheet USER SETUP table measurements and equations in Appendix F Ob Gyn Studies on page 7 37 3 15 8 Vascular Study The Vascular study sheet is displayed in Vasc Medical Application A vascular study sheet is available in Radio Medical application when PW or CW mode is selected See Vascular study sheet measurements and equations in Appendix E Vascular Study on page 7 31 3 15 9 Cardiology Study The Cardiology study includes four study sheets Left Ventricle Study Mitral Valve Study Aortic Valve Study a Right Ventricle Study See Cardiology study sheets measurements and equations in Appendix D Cardiology Study on page 7 11 3 94 SIGMA 110 SIGMA 330 10 12 01 3 16 ECG Option The optional ECG Module can be coupled to SIGMA 110 and SIGMA 330 systems via COM1 input located on the rear connector panel The ECG Module inc
89. hardware problem If this message is displayed the user must inform the service team 5 5 17 Error 16 Flashcard removed while printing The following error is displayed if the flashcard is removed while the SIGMA is printing images on a printer Error 16 Flashcard removed while printing The flashcard has been removed while printing Print process cancelled 5 5 18 Error 17 Internal communication Fatal error This internal communication error is similar to the Error 11 but it happens when the host does not receive message acknowledgement from the processor located on the SUBSI board In this case the internal communication error message is displayed To acknowledge this message the user presses on any key and a message informs the user that the system will be powered off This error can happen when the SUBSI processor has been reset due to software or hardware problems If this problem persists the user should call the service team To help the service team to find the cause of this problem the user must press on the lt H gt key when dialogue is displayed and printout the current displayed screen This screen contains information concerning the last sent messages 15 10 01 TROUBLESHOOTING 5 21 5 22 This page is intentionally left blank SIGMA 110 SIGMA 330 15 10 01 10 12 01 OPTIONS AND ACCESSORIES 6 OPTIONS AND ACCESSORIES 6 2 SIGMA 110 SIGMA 330 10 12 01 6 1 Options SIGMA 110
90. in 2D Doppler ACOUSTIC POWER OUTPUT Fulfils acoustic output display standard Complies with FDA acoustic output limits e Automatic power output adjustment versus medical application for optimal Doppler per formance ALARA User selectable Doppler transmit power attenuation 8 positions between 0 and 21 dB 15 10 01 INSTRUMENT DESCRIPTION 1 57 AVA KONTRON MEDICAL 1 8 5 Colour Doppler Modes MODES e Steerable Color Flow Mapping CFM on electronic array probes e Velocity Variance and Power mode e Automatic 2D CFM image update when adjusting Doppler cursor position SIGNAL PROCESSING Multi frequency CFM mode 2 5 3 5 and 6 MHz Probe dependent and user selectable High pass wall filter 6 cut off frequencies adjustable between 44 to 4400 Hz depend ant on velocity range Colour gain control 32 positions between 0 and 20 dB 4 positions colour persistence Velocity Ranges from 125 Hz to 7 5 kHz Doppler shift PRF 2 or 1 6 cm s to 2 8 m s full scale depending on probe frequency and medical application CFM WINDOW e From 10 to full length of 2D sector trackball controlled resize From 10 to full width of 2D sector trackball controlled resize Trackball control of window position within 2D sector DISPLAY Up to 128 colour shades 8 levels of turbulence 8 user selectable colour maps for optimum rendering of either low velocities high veloc ities and turbulence 9 positions of baseline shift
91. intended for visualization by ultrasound of internal organs for medical diagnostic purposes only It must be operated by qualified and trained Physician or Sonogra pher The particular organs visualized and the methods of visualization depend on the particular transducer used and the imaging mode employed Modes are used two senses in this manual Imaging Modes refer to the method of depicting the organs visualized and are explained below It is also used to indicate various operational modes such as freeze zoom cine etc In general it is obvious when a non imaging mode is referred to In the manual they are explained when they are first used The principal imaging modes of the SIGMA 110 330 and their abbreviations which are used throughout this manual are as follows 2D Two dimensional representation of a slice in the body often called B mode TM Often called just M Mode the ultrasound beam is stationary giving an A scan but the time axis moves with the result that moving organs can be easily visualized PW Pulse Wave Doppler which permits determining the velocity of blood or another organ in the interior of the body CW Continuous Wave Doppler which determines the velocity of flow or movement of all ele ments within the range of the probe CFM Colour flow mapping which superimposes a map of the velocity of moving organs or blood on top of a 2D scan B scan of the organs
92. is displayed when the user tries to restore a configuration from an empty flashcard Warning 8 No data to restore ES 5 4 3 5 Warning 9 Invalid flashcard for archive A formatted flashcard is plugged instead of a SRAM and the user wants to archive images A SRAM must be plugged Warning 9 This is nota SRAM Archive is not possible with this flashcard 5 12 SIGMA 110 SIGMA 330 15 10 01 5 4 4 Miscellaneous checks 5 4 41 Warning 10 Invalid VLCUS serial number This warning message is displayed at start up if the serial number of the VLCUS board is not correct Warning 10 Invalid VLCUS serial number VLCUS serial number not defined ox If the message persists the user must inform the service team 5 4 4 2 Warning 11 Printer not responding This message is displayed when the printer is not responding The user must check the printer broken printer printer Off the printer cable If the problem persists the user must inform the service team 5 4 4 3 Warning 12 Invalid configuration key This message is displayed when the user enters an invalid configuration key from the preference menu Warning 12 Invalid configuration key Configuration key is invalid no option will be activated ox 5 4 44 Warning 13 Name for a label list already exists This message is displayed when the user enters a label list name that already exists Warning 13 A list with the name you specified already ex
93. module has a Class CF degree of protection WARNINGS The system must be properly grounded to prevent shock hazards Protection is provided by grounding the chassis with a three wire cable and plug the system must also be powered through a properly grounded receptacle Electrical shock hazard Do not remove any panel Refer servicing and internal adjustments to qualified KONTRON personnel only For continued protection against risk of fire replace fuses only with fuses of the same type and rating see Chapter 2 7 Power Source Connection on page 2 10 The equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air oxygen or nitrous oxide Do not use the system in the presence of flammable anaesthet ics Explosion is a hazard under such conditions The system not watertight and provides a class 0 degree of protection to liquids do not expose the system to rain or moisture Avoid placing liquid containers on the system Remove probes and electrocardiography leads from patient contact before applying a high voltage defibrillation pulse Like any other ultrasound equipment the SIGMA 110 330 uses high frequency signals which could interfere with pacemakers You should be aware of this small potential hazard and immediately turn off the unit if interference in the pacemaker operation is noted or suspected If you drop or strike a probe do not use it until a measurement of the electrical l
94. moving the trackball up or down and validates it by pressing on the upper left trackball key A rectangle is displayed on the ultrasound image the user moves it to the desired place By pressing on the upper left trackball key the user fixes the label at the current position Left Rig fo Right Lot e Isthmus es Thyroid t Thyroid Longitudinar Longitudinal 3 12 4 7 Erasing Labels Q Clear label By pressing on the Clear key the user will erase the last displayed label Q Clear all labels By pressing on the Clear all key the user will erase all the displayed annotation labels texts arrows and body marker Remark Labels are identical to text annotation so in the preference menu you can choose between keeping text and labels when unfreezing or not See Chapter 3 6 5 2 Display on page 3 15 issue Annotation for details 10 12 01 OPERATING INSTRUCTIONS 3 63 AVA KONTRON MEDICAL 3 12 5 Arrows Selecting Arrows in the ANNOTATION Menu displays an arrow on the left side of the screen Use the trackball to move the arrow anywhere on the screen and the softpot to change its orien tation 8 positions are available It is possible to display up to 20 arrows anywhere on the screen gt oS COOH Arro
95. on a memory card 1 Insert the memory card in the dedicated slot on the right side of system Put the card in the slide guide respecting the connection direction label side up and push it gently up to the connector stop 2 Press FREEZE key 3 Press Store key If the PRINT 2 key is associated with storing pictures on memory cards you can directly press the PRINT 2 key to freeze the screen and store the picture on memory card 3 11 2 Archive Display of Stored Images 3 11 2 1 Panels of 16 Images Pressing Archive displays the archive menu and a screen layout divided in 16 locations dedi cated to insert the images stored on the memory card The image selected by 02 04 01 10 53 35 default is the last one stored The border of the selected image is high lighted in yellow for SIGMA 330 For selecting an image use the trackball Each image can be named by the user The title of the selected image is automatically dis played between the menu and the bottom of the panel SIMPSON Left Ventricle ll Delete Del All Undo A set of 16 images can be x 20 imag displayed this consists of an images panel When more than 16 images are stored more than one panel exists Press one of the upper SET key of the trackball to invoke the full screen display mode the selected image is displayed 3 11 2 2 Menus The labels of the menu are automatically updated when the user changes the track
96. page 7 50 BPD Hadlock 1540 2 10 12 2 42 0 8 3 6 page 7 51 BPD Hansmann 1600 1 6 9 8 11 39 1 2 5 page 7 52 BPD Hobbins 1540 1 6 8 9 1 26 4 2 7 2 7 7 54 BPD Hohler 1540 2 10 11 8 42 1 0 0 page 7 55 BPD Merz 1540 2 5 9 8 12 5 41 5 1 2 5 5 7 53 15 10 01 APPENDICES 7 45 7 46 BPD Lai Yeo Hohler Jeanty 1540 2 5 9 6 0 2 7 3 1 3 16 0 0 6 7 8 14 41 4 86 14 14 8 22 0 8 3 3 0 8 1 5 2 5 page 7 56 page 7 57 page 7 74 page 7 72 1540 0 6 5 4 page 7 73 Rempen 1540 0 2 7 8 page 7 75 Robinson Bessis 1540 0 42 7 78 1 04 7 34 13 41 page 7 71 page 7 58 Hadlock 1 7 9 12 8 40 4 page 7 59 Hansmann 1 4 7 5 15 40 page 7 62 Hohler 1 8 12 40 8 page 7 61 Jeanty 1 8 12 6 40 page 7 60 O Brien 1 4 6 12 23 5 page 7 60 Merz 0 9 7 7 12 5 41 5 page 7 63 Lai Yeo Hansmann 1 3 7 3 1540 0 7 3 4 14 41 page 7 64 page 7 77 Hellman 1540 0 4 4 7 page 7 76 Ramzin FML GES GES GES 1540 1540 0 8 6 7 12 5 41 5 0 7 4 5 7 65 Hadlock 1540 0 77 5 71 8 36 9 2 35 8 6 33 1540 1 9 6 1 3 11 5 2 11 3 1 10 8 SIGMA 110 SIGMA 330 13 4 41 6 12 5 41 5 14 41 16 41 12 5 41 5 12 5 41 5 15 5 41 1 3 3 4 1 5 8 0 8 4 1 4 1 6 5 1 3 5 1 9 4 1 page 7 76 15 10 01 F 5 User Table Sheet 14 01 98 08 30 31 OB GYN SETUP
97. parts 3 54 SIGMA 110 SIGMA 330 10 12 01 AVA KONTRO MEDICAL a the six first characters are based on the patient name or the image title as shown below Patient name Image Tite File name of image files File name of report files Not defined Not defined Default name Default name b b Defined Not defined Patient name Patient name Not defined or Defined a IMAGE or REPORT b 6 first characters of the patient name completed if necessary by characters 6 first characters of the title completed if necessary by characters Defined Title a the two last characters are reserved for the number of the image or report e g 01 02 03 99 3 11 4 Patent Report and Patient ID with KIPRISM The icon is used to store the current state of the report For details on the different icons see Appendix B Report Menu on page 7 5 3 11 4 1 Ob Gyn Medical Application Report Menu This menu is available on the Report when the medical application Ob Gyn is chosen EI L jeu ES TER The STORE key doesn t save the current medical application or the current page displayed but saves all valid measurement in all medical applications O Ly 3 11 4 2 Vasc Cardio Radio Medical Application Report Menus This menu is av
98. port on the SIGMA there is a defect ECG To correct this problem the user should verify the ECG connection if the problem persists he should call the service team 15 10 01 TROUBLESHOOTING 5 5 AVA KONTRON MEDICAL 5 3 1 3 LEAD OFF Message t t Lead Off Angle Dual Zoom Freq Biopsy 2D Inv Right LEAD OFF is displayed when ECG mode is active and clamps are defective clamps not correctly set on the patient Red clamp on right arm Yellow clamp on left arm Black clamp on right leg To correct this problem verify the clamps position on the patient or verify the clamps or call the service team if the problem persists 5 3 1 4 BAD ELECTRODE Message t 1 Bad Elect Angle Dual Zoom Freq Biopsy 2D Inv Right mm BAD ELECTRODE is displayed when ECG mode is active and clamps are defective clamps are not connected To correct this problem connect the clamps to the patient or verify the clamps or call the service team if the problem persists 5 3 1 5 ECG ERROR Message Q t t ECG Error Angle Dual Zoom Freq Biopsy 2D Inv Right Triggem ECG ERROR is displayed when ECG mode active and a failure in the ECG software module happens 5 6 SIGMA 110 SIGMA 330 15 10 01 4 HA MEDICAL To correct this problem freeze and unfreeze the system Call the service team if the problem persists 5 3 2 Measurement and Biometry 5 3 2 1 Invalid Results
99. section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is not reported for the reason listed 15 10 01 APPENDICES 7 135 4 KONTRON MEDICAL Transducer Model 6 5 MC Operating Mode Color Flow Doppler TIS TIB TIC non scan Index Label MI non Scan Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value a 2 5 E b Pr 3 MPa 2 Wo4 mW 87 1 min of W 3 z1 3 21 1 mW 21 cm 2 aM 2 2 zm E Zsp cm s 9 deq Zsp cm z EET MHz 6 1 P lize x cm 0 67 Dim of Aaprt lt cm 0 65 PD msec 1 43 6 PRF Hz S Pr PIlmax MPa deg cm FL 3 64 Len 8 3 FLy 364 IpA 3Mlmay W cm depth cm 2 Doppler frequency MHz 6 1 color depth min _ color angle min g resolution med 5 wall filter max 0 application Carotid velocity range Hz 250 steering angle degrees 0 Notes a This index is not required for this oper
100. step in the defined limits using the selected step a select the start and the end images of the cine replay Start image End image To select the start and the end images of the cine loop sequence the user selects them using the trackball the cine loop is in manual mode and validates his choice by selecting the suitable key a reset the start and end image selection using the Reset key The complete cine loop sequence can then be played define the number of frames per second fps displayed during the cine replay using the fps key This key is an incremental key and the frame rate replay is changed using the incremental pot The frame rate of the cine replay is always lower or equal to the acquisi tion frame rate and has to be chosen among the following values 1 2 4 6 8 12 16 25 fps The default value is 12 fps when this value is possible else 1 fps is selected a store the selected image a SRAM flashcard using the Store key a review the images stored on a SRAM using the Archive key 10 12 01 OPERATING INSTRUCTIONS 3 49 KONTRON ERZ HAN MEDICAL 3 10 Magnifier in 2D and CFM Mode Press MAGNIFY key to magnify the image displayed on the screen Use the trackball to move and select the portion of the image to be displayed In 2D CFM mode use the upper left select key of the trackball to switch between moving magni fied image and moving CFM window if magnifying is active Press MAGNI
101. system 3 20 10 1 Menu keys Refer to Menu keys on page 3 113 3 20 10 2 Foot switch The foot switch allows the user to send some commands to the SIGMA In PC mode the two but tons are affected according to the following acquisition mode left button gt nothing right button press event start scan and stop scan review mode when acquisition is stopped short step 1 second on the right button gt open save dialogue long step gt 1 second on the right button gt open delete dialogue e step on the right button gt OK step on the left button gt CANCEL 3 20 11 PACS option For more information about the PACS software refer to the User Manual of the PACS software delivered with the system 3 20 12 Connection to a Network The SIGMA 330 Excellence provides a RJ 45 10 100 Mbps Ethernet connector Please contact your local KONTRON MEDICAL representative to change the parameters of the Network con nection Never connect Network J 45 directly to the system use a medical grade network isolator which must comply with IEC 601 1 specifications Wrong connections may compromise the electrical safety of the system KONTRON MEDICAL provides a medical grade isolator on request see Chapter 6 3 KAccessoriesS on page 6 5 for ordering 3 20 13 Installation of peripherals Please contact your local KONTRON MEDICAL representative to install peripherals on the sys tem AN Never connect additio
102. the reason listed 7 128 SIGMA 110 SIGMA 330 15 10 01 not reported for the reason listed 15 10 01 APPENDICES MEDICAL Transducer Model 5 0 LV Operating Mode B mode TIS TIB TIC Index Label MI MEM Il saa eee Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value 1 5 a Pr3 2 9 g Wo mW min of W 3 z4 3 21 1 mW 21 cm A 25 cm 2 Zp 3 11 deq Zsp cm gt fc MHz 3 88 Dim of Aaprt x cm z m 2 PD msec 0 54 6 PRF Hz 1000 Pr Pllmax MPa 42 deq Pllmax cm 2 Focal Length FLy cm 9 Fly cm IPA 3 M max W cm 342 4 depth cm 15 5 frequency f f f 5 angle 75 focus cm 3 Notes a This index is not required for this operating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is 7 129 4 KONTRON MEDICAL Transducer Model 5 0 LV Operating Mode M mode TIS TIB TIC Ind
103. tool 3 20 2 SAFETY PRECAUTIONS Please review the information in this section before using the Integrated PC Please also review the information in the user manuals of the 3D and or PACS software gt Maintenance service changes of the device installation upgrades setups may only be performed by KONTRON MEDICAL trained and authorized personal Warranty might be void Technical documentation is worthless without adequate training Please contact KON TRON MEDICAL for further information DO NOT INSTALL ANY OTHER SOFTWARE Contact your local KONTRON MEDICAL representative if you want to install software Do only use accessories and replacements which are recommended by KONTRON MEDICAL Do not remove disks from the disk drive optional during disk read and write operations when the disk drive light is on Removing a disk during read and write operations can cause incomplete storage of data files resulting in data loss KONTRON MEDICAL is not responsible for problems attributable to unauthorized changes additions or deletions to KONTRON MEDICAL software or hardware or unau thorized installation of third party software KONTRON MEDICAL is not responsible for loss of data KONTRON MEDICAL recom mends that you back up regularly your data SIGMA 110 SIGMA 330 10 12 01 3 20 3 Entering PC remote control mode In standard mode SIGMA keyboard and trackball control the ultrasound system A specific key sequence has to b
104. ue dete 2 10 2 7 1 Input Power SOBICO speret teneo ter qp votis hti ere a 2 10 2 7 2 Output Power SOUCO ici recer tai p reds e LE RR VR a ER D IR d 2 11 2 8 Connecting a PIODO eus D rtv neto 2 12 2 8 1 SIGMA 330 Expert and SIGMA 330 Excellence Probe Assignment 2 12 2 8 2 SIGMA 110 Light Master and SIGMA 330 Master Probe Assignment 2 13 2 8 3 JProbe Gonecliors uses e oe en cette aay vi Ceu a Hexe ier ane ne eui 2 13 297 Connection oPPeripherals iug ant o DRE ERE ru pU RM REDE 2 15 2 9 1 Electrical safety with 2 15 2 9 2 Recommended 2 17 2 9 3 Archiving on Personal 2 17 2 9 4 Connection of B amp W Video 20 2 00000 2 18 2 9 5 Connection of Colour Video 2 4 44040 2 19 viii SIGMA 110 SIGMA 330 10 12 01 H 4 KONTRON HINXMEDICAL 2 9 6 Video Recorder 2 20 29 VEGG MDOUIE oci idea oai ce rece rer 6 2 22 2 90 67 Colour MOMMOIS roar teers Serene gee ora ia 2 23 2 9 9 Black amp While Monitor des 2 25 2 910 PHDIGE i tos dence aeo aal db E tec C c 2 26 2 9 11 Connection wit
105. unpredicta ble The user can vary the spectral velocity range this does NOT however change the system s PRF Implementing ALARA with the SIGMA 110 330 Prudent use implies that during an exam the user should use for the shortest time the least amount of acoustic output to obtain the necessary clinical information for diagnostic purposes In other words your goal is to keep the TI and the MI indices as low as possible for the shortest time while obtaining the necessary clinical information This section does not cover the patient and technique factors which may influence the indices such as the patient body size the tissue perfusion characteristics the presence or the absence of fluid etc select the appropriate application when you select the probe 15 10 01 GENERAL INFORMATION xxvii depending on the patient characteristics and the type of exam see Intended Use Section select the appropriate probe and frequency use the system capabilities to preset the SIGMA 110 330 to default each mode according to your needs or specific applications this will reduce the need for real time interactions and help you obtain useful images quickly thus reducing ultrasound exposure start scanning with a low output level and optimize the focusing the gains and all other sys tem adjustments if this is not adequate for diagnostic purposes then increase the output level use the Output Display feature to guide your settings remember t
106. xxii SIGMA 110 SIGMA 330 15 10 01 4 KONTRO MEDICAL The ALARA As Low As Reasonably Achievable principle is the guideline for prudent use dur ing an exam the user should use for the shortest duration the least amount of acoustic output to obtain the necessary clinical information for diagnostic purposes Ultrasound Bioeffects Although diagnostic ultrasound has an excellent history of safety it has been known for a long time that ultrasound at certain levels can alter biological systems The AIUM Bioeffects Committee describes two fundamental mechanisms by which ultrasound may induce biological effects non thermal or mechanical mechanisms and thermal effects Non thermal bioeffects also referred to as mechanical bioeffects seem to be caused by the alternate expansion and contraction of tissue induced when ultrasound pressure waves pass through or near gas The majority of these non thermal interactions also known as cavitation deal with the generation growth vibration and possible collapse of micro bubbles within the tis sue The occurrence of cavitation depends on a number of factors such as the ultrasonic pres sure and frequency the ultrasonic field focused or unfocused pulsed or continuous the nature and state of the tissue and boundaries Mechanical bioeffects are a threshold phenomenon occurring only when a certain level of output is exceeded However the threshold level varies depending on the tissue The po
107. your local waste disposal facility 4 10 SIGMA 110 SIGMA 330 10 12 01 15 10 01 5 TROUBLESHOOTING TROUBLESHOOTING 5 2 SIGMA 110 SIGMA 330 15 10 01 5 1 Handle Error and Warning Messages This troubleshooting procedure lists the checks for remedying simple defects Extensive trouble shooting is explained in the technical service manual and is only performed by the local service engineer Points to check by the user to avoid Error and Warning Messages Check control settings Incorrect control settings may suggest a fault that does not exist If there is any question about the correct function of any control consult Sections 2 and 3 of this manual Check connections and fuses Check cables for proper interconnection Disconnect the unit from the power source and check the fuses in the power source recepta cle if the receptacle is fused Check monitor operation 15 10 01 TROUBLESHOOTING 5 3 AVA KONTRON MEDICAL 5 2 Introduction and Rules This chapter contains a description of the different warnings and errors managed by SIGMA 110 330 5 2 4 Rules Warnings and Errors messages are written e in dialogue box Warning 5 Flashcard not present Please plug a SRAM flashcard directly on the screen red on colour monitors example NO ECG is written on the bottom right side of the screen 5 2 2 Definition Different terms to qualify the displayed messages are us
108. 0 HuL cm EBD weeks EBD weeks 11 EBD weeks G 4 2 1 Source Lai G S H Yeo Reference Charts of foetal biometry in Asian Singapore Med J 1995 Vol 36 628 636 7 66 SIGMA 110 SIGMA 330 15 10 01 AVA KONTRO MEDICAL G 5 Transabdominal Diameter TAD from Merz 32 12 18 35 5 2 9 TAD from Merz Lr EBD week EBD week f amp EBD week TAD cm G 5 0 1 Source Eberhard Merz Ultrasound in Gynecology and Obstetrics Textbook and Atlas 1991 Georg Thieme Verlag 15 10 01 APPENDICES 7 67 G 6 Thoracic Diameter THD from Hansmann 5 19 25 ii THD from Hansmann 1 EBD week W EBD week EBD week THD cm G 6 0 1 Source Hansmann Ellison Roynon Kontron Medical Sound Velocity 1540 m s Values are scaled from a sound velocity of 1600 m s as in the publica tion 1540 m s for the table Uncertainty two standard deviation 7 68 SIGMA 110 SIGMA 330 15 10 01 G 7 Anterior Posterior Diameter APD G 7 1 APD from Ramzin G 7 1 1 Source Dr Ramzin Basel Sound Velocity 1540 m s Uncertainty two standard deviation G 7 2 APD from Bessis APD from Bessis EBD week EBD week 4 EBD week G 7 2 1 Source The values have been picked on the graphic provided by Dr Gortchakoff Author Dr Bessis 15 10 01 A
109. 0 SIGMA 330 10 12 01 2 9 9 Black amp White Monitor SIGMA 110 and SIGMA 330 feature output port dedicated for an additional video monitor Use only 75 Ohm not 50 Ohm coaxial cables to connect the external monitor If the monitor includes UNDERSCAN OVERSCAN option choose OVERSCAN for PAL standard and UNDERSCAN for NTSC Black amp White VIDEO PRINTER Black amp White MONITOR Figure 2 18 Connection of B amp W monitor with Video Printer 1 Reference 862 169 Signal cable for Monitor and Video Printer BNC BNC 75 Ohm 2 Reference 481 033 Remote control cable for Video Printer ECG uomo Fs AVR Black amp White MONITOR Figure 2 19 Connection of B amp W monitor 1 Reference 862 169 Signal cable for Monitor BNC BNC 75Ohm 10 12 01 INSTALLATION AVA KONTRON MEDICAL 2 9 10 Printer An optional Parallel Printer can be coupled to SIGMA 110 and SIGMA 330 systems via PRINTER output located on the rear connector panel It is recommended to use a standard cable length should not exceed 2 meters The printer must comply with Hewlett Packards PCL level 3 printer language t T SGT EZ D m nam 1 ems amp Figure 2 20 Connection of Line Printer The recommended printers are HEWLETT PACKARD Deskjet 930C Deskjet 950C Deskjet 990Cxi and 9xx series For these printers a parameter set can be saved by the system 2 9 10 1 Printer
110. 1 1 through serial port 240 x 8 bit second QRS trigger available ECG Gain 1000 1V 1 mV Heart rate up to 180 bpm Recovery time after defibrillaror shock gt 5 sec B MODE TRIGGER in single and dual B mode available trigger moment may be set by user For dual pad modes two independent triggers can be set DISPL AY and CINE REVIEW Display trace on video screen e Indication of time relationship between 2D mode image and ECG trace by marker on ECG trace Cine review on trace modes is also available 1 89 EasyPrint Direct output to inkjet printer e Compatible with HP PCL level III 1 8 10 USB Link Digital transfer of images and report text files to Personal Computer through USB cable Compatibility refer to Chapter 3 18 2 Compatibility on page 3 99 15 10 01 INSTRUMENT DESCRIPTION 1 59 AVA KONTRON MEDICAL 1 8 11 Peripherals Optional All the following peripherals can be connected to the system VCR VHS and S VHS B W video printer Color video printer Parallel DeskJet printer PC compatible for images EasyPrin B W monitor Color monitor report printout 1 8 12 Inputs Outputs S VHS VHS including audio input output for VCR connection PAL NTSC compatible video playback automatically fed to the monitor Black amp White video composite output for B W video printer connection Double footswitch Freeze Print Select image Memory card c
111. 1 1 BPD from Bessis sa BPD from Bessis EBD week W week 4 amp EBD week BPD cm 6 1 1 1 Source The data are those provided by Dr Bessis to M Le Bel Same as SIGMA 20 see memo from Ch G hwiller dated June 23 1983 15 10 01 APPENDICES 7 49 AVA KONTRON MEDICAL G 1 2 BPD from Campbell e ipic 98 BPD from Campbell EBD week W EBD week EBD week BPD cm G 1 2 1 Source S Campbell G B Newman Growth of the fetal biparietal diameter during nor mal pregnancy The Journal of Obstetrics and Gynaecology of the British Commonwealth 78 513 June 1971 7 50 SIGMA 110 SIGMA 330 15 10 01 G 1 3 BPD from Hadlock G 1 3 1 Source Hadlock Deter R L Harist B Park S K Fetal Biparietal Diameter A Critical Re evaluation of the Relation to Menstrual Age by Means of Real time Ultrasound a a a ae a ae BPD from Hadlock 1 EBD week EBD week EBD week 4 BPD cm J Ultrasound Med 1 97 April 1982 15 10 01 APPENDICES 7 51 AVA KONTRON MEDICAL G 1 4 BPD from Hansmann BPD from Hansmann 1 EBD week week EBD week 6 BPD cm G 1 4 1 Source The values p
112. 2 ra from Merz O EBD week EBD week EBD week FML cm G 3 7 1 Source Eberhard Merz Ultrasound in Gynecology and Obstetrics Textbook and Atlas 1991 Georg Thieme Verlag 15 10 01 APPENDICES 7 63 AVA KONTRON M DICAL G 3 8 FML from Lai Yeo FML cm EBD week 1 6 14 8 0 8 2 5 18 0 0 9 3 0 20 0 1 0 4 1 24 0 1 1 4 6 26 0 1 2 5 3 29 0 1 4 5 7 31 0 1 6 6 3 34 0 1 8 6 8 37 0 2 3 6 9 38 3 2 7 FML from Lai Yeo 4 1 46 53 57 63 6 8 FML cm 6 9 EBD weeks A EBD weeks 1 EBD weeks G 3 8 1 Source Lai G S H Yeo Reference Charts of foetal biometry in Asian Singapore Med J 1995 Vol 36 628 636 7 64 SIGMA 110 SIGMA 330 15 10 01 G 4 Humerus Length G 4 1 Humerus Length from Merz HuL from Merz EBD week EBD week amp EBD week HuL cm G 4 1 1 Source Eberhard Merz Ultrasound in Gynecology and Obstetrics Textbook and Atlas 1991 Georg Thieme Verlag 15 10 01 APPENDICES 7 65 AVA KONTRON MEDICAL G 4 2 HuL from Lai Yeo HuL cm EBD week 2 2 17 0 1 0 2 4 18 0 1 0 3 3 22 0 1 2 3 9 25 0 1 5 4 5 28 0 1 7 4 8 30 0 1 9 5 1 32 0 2 3 5 4 34 0 2 8 5 7 36 0 3 3 5 8 37 0 4 0 Hul from Lai Yeo 4
113. 23 label2 Ellipse 0 523 label3 Thyroid 0 479 label4 Thyroid 0 479 15 10 01 APPENDICES 7 85 AVA KONTRON MEDICAL b Cardiac Output Diam Diameter of the vessel in cm c Continuity Equations Diam1 Diameter 1 in cm d Hip Angles Alpha Alpha angle in degrees Type Type of the Alpha angle Beta Beta Angle in degrees Type Type of the Beta angle This measurement is made in 3 steps e The Baseline is a line drawn from the ilium to the epiphysis e The Alphaline is a line drawn from the triradiate cartilage to the lateral aspect of the bony acetabulum e The Betaline is a line drawn from the lateral aspect of the labrum to the bony margin of the acetabulum H 2 Equations Volumes in cm3 Coeff D1 D2 D3 V v D Coeff D1 D2 D3 User modifiable coefficient Distance 1 in centimetres Distance 2 in centimetres Distance 3 in centimetres Volume in cm Ellipsoid Volumes in cm3 by default D1 D2 D3 7 86 Vau a 202203 Distance 1 in centimetres Distance 2 in centimetres Distance 3 in centimetres Volume in cm SIGMA 110 SIGMA 330 15 10 01 Thyroid volumes cm3 by default v D0 479 D1 D2 D3 D1 Distance 1 in centimetres D2 Distance 2 in centimetres D3 Distance 3 in centimetres V Volume cm Reference W Wiedermann K Wurster
114. 2D Frozen Menu This menu is displayed by pressing the FREEZE button p a Store if KIPRISM is available To store the actual frozen image in memory this button has to be pressed a Archive if KIPRISM is available Enters the KIPRISM archive if a minimum of one image is stored on the formatted Flash Card a Cine Displays the menu dedicated to cine replay management For details of Store Archive function see Chapter 3 11 Digital Archiving KIPRISM on page 3 51 3 7 1 4 2 Gain Overall gain is controlled by rotating the uppermost knob on the right side of the keyboard 32 positions are available a TGC is controlled by sliding the five rectilinear potentiometers on the top right of the key board These five compensation gain controls are independently acting on the correspond ing exploration areas Normal setting is all five TGC potentiometers centered 3 30 SIGMA 110 SIGMA 330 10 12 01 3 7 2 Time Motion Press TM key to select TM mode see figure 1 4 Keyboard on page 1 13 to locate the key The TM marker is positioned over the 2D image The echoes corresponding to the selected beam are displayed on a scrolling trace 1 10 12 01 The first time that you press key you enter double image 2D TM display The TM line marker is superimposed on 2D live Image The 2D TM Menu is displayed on the screen Use the trackball to move the line over the 2D image so as to pla
115. 3 3 Measuring an Ellipse Technical Data L LOL bebe 1 Press F3 Ellipse to select ellipse measurement 2 Usethe trackball to move the first marker to the desired position 3 Press upper left SET key to fix the first marker the second marker is now available 3 70 SIGMA 110 SIGMA 330 10 12 01 4 KONTRO MEDICAL 4 Use the trackball to move the marker and define the length of the first axis 5 Press upper left SET key to fix the first ellipse axis an ellipse is now displayed 6 Use the trackball to modify the ellipse shape superpose the ellipse and the element to be measured 7 Press upper left SET key to finish the measurement The result is immediately dis played on the screen For this measurement two results are displayed the area in square centimetres and the circum ference in centimetres 3 14 3 4 Measuring an Angle Technical Data L LOL bebe 1 Press F4 Angle to select angle measurement 2 Use the trackball to move the first marker angle vertex to the desired position 3 Press upper left SET key to fix the marker the second end marker of the first angle side is now available 4 Use the trackball to move the second marker to the desired position 5 Press upper left SET key to fix the first angle side the second end marker of the sec ond angle side is now available 6 Use the trackball to move this marker to the desired position 7
116. 4 07 9 Dim of Aaprt x cm z m 2 PD msec 0 54 6 PRF Hz 1000 Pr Pllmax MPa 4 0 deq Pllmax cm 5 Focal Length FLy cm 9 Fly cm IPA 3 M max W cm 312 6 depth cm 10 5 frequency f f f 5 angle 75 ui focus cm 3 Notes a This index is not required for this operating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is 7 133 4 KONTRON MEDICAL Transducer Model 6 5 MC Operating Mode M mode TIS TIB TIC Index Label MI PAPER Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value a lt 1 0 lt 1 0 b Pr3 MPa 2 Wo mW min of W 3 z1 lrA 3 21 mW 21 cm a bp E Zsp cm 8 deq Zsp cm 4106 2 2 Sie GEA X cm Im O 2 PD msec 6 PRF Hz S Pr Pllmax MPa 5 deq Pllmax cm L th FL cm ocal Len E d FL em m m IpA 3Mlmax W cm depth frequency focus
117. 5 100 VelRange This function changes the Velocity Range Velocity range depends on Doppler frequency It can be displayed in kHz or m s When selecting m s it is displayed in cm s for velocities lower than 1 m s and in m s for velocities greater than 1m s Q PRF PRFx2 PRFx3 This function changes the Pulse Repetition Frequency PRFx2 and PRFx3 are extended ranges where is multiplied by 2 and 3 respectively WallFilt This function is used to select the wall filter cut off frequency The selected frequency value is displayed on the screen in the technical data area on the right side of the screen The fol lowing wall filter frequencies are available 50 75 100 150 200 300 400 500 750 1000 Hz Sp Inv This function reverses the up down orientation of the spectrum displayed on the screen D D a Freq This function is used to select the different Doppler frequencies 2 3 4 8 MHz Doppler fre quencies are available and can be selected by using MP potentiometer An optimized Dop pler frequency is automatically selected according to the operating probe However the operator can select another frequency except for pencil probes Note The available Doppler frequencies are dependent of the selected probe For instance Pencil Probes are used at only one frequency 3 36 SIGMA 110 SIGMA 330 10 12 01 D Angle This function is used to adjust angle correction Use the MP potentiometer to rotate the flo
118. 5 055 Memory card Flash 4 M for backing up 481 068 FREEZE PRINT Footswitch 503 126 Fuse 5 X 20mm 528 129 Fuse 5 X 20 mm T6 3A 717 150 Fuse 5 X 20 mm T4A 524 204 Fuse 5 X 20mm 2 411 353 Power cable EURO D CEE 22 487 848 Power cable North American Hospital Grade 412 139 Power cable CEE22M CEE22F for integrated peripherals 488 364 Power cable CEE22M French female for peripherals 481 033 Remote control cable for Video Printer 862 169 Coaxial cable 75 Ohm BNC BNC L 2m 486 434 VCR adapter for SVHS 481 076 Cable for S VHS VCR 487 252 Cable for VHS VCR 485 659 Single S VHS cable for color printer 479 764 Cable for Sony colour monitor or colour video printer 479 772 Mitsubishi colour monitor cable 485 861 CABEL colour monitor cable 479 802 Patient cable for ECG 430 706 Cable for equalization potential 487 163 USB Cable 485 519 Matrox Orion Video Cable 487 155 VGA Video Cable 487 309 Keyboard Sticker CTRL ALT ALTGR 487 368 Keyboard Sticker CAPS DEL 490 199 Cable D Sub 25 M F L 1 5 m 489 859 Printer port isolator 488 542 S Video isolator 490 024 S Video distributor 488 550 BNC Video Isolation Amplifier 489 689 Adaptor S VHS F F mini DIN 487 732 Medical Grade isolating
119. 5 10 01 APPENDICES 7 97 AVA M KONTRON ICAL K 2 2 5 Mitral Valve Effective Opening Area Description Sono Win Chapter Sub Aortic Diameter Area computed from DiamAOV DIAM SAA Card D Mitral Valve Card D Mitral Valve Sub Aortic Velocity Time Integral Velocity Time Integral at Mitral VTlaov Card D Mitral Valve VTImv cm VTI12 m Card D Mitral Valve Valve valve FOA computed from EOA cm2 MVA2 mm2 Card D Mitral Valve VTlaov and VTImiv Pressure Half Time PHT msec PHT ms Card D Mitral Valve Peak Velocity for E wave m s Vpeak1 m s Card D Mitral Valve Valve Area computed from Pres EOA cm2 MVA cm2 Card D Mitral Valve sure Half Time K 2 3 Aortic Valve K 2 3 1 2D study Description SIGMA Sono Win Chapter Aortic Valve Diameter AVD cm DIAM mm Card D Mitral Valve Aortic Valve Area AVA cm2 MVA cm2 Card D Mitral Valve K 2 3 2 SP study Description Sono Win Chapter Velocity Time Integral VTI Card D Aortic Valve VTI Peak Velocity Vpeak_calc Card D Aortic Valve VTI Peak Gradient peakPG_calc Card D Aortic Valve VTI Mean Gradient meanPC_calc Card D Aortic Valve Pressure Half Time PHT ms Card D Aortic Valve Left Ventricle Pre Ejection Period PEP ms Card M MV and Aorta Stroke Volume ml SV ml Card D Aortic Valve S
120. 6 628 636 15 10 01 APPENDICES 7 83 H 4 KONTRON HN MEDICAL G 12 Binocular Distance BOD from Jeanty BOD cm EBD week G 12 0 1 Source Jeanty Cantraine F Cousaert E Romero R Hobbins J C The Binocu lar Distance A New Way to Estimate Fetal Age J Ultrasound Med 3 241 243 1984 G 13 Occipital Frontal Diameter OFD from Merz Lo EBD EBD week p Hr OFD from Merz EBD week EBD week EBD week OFD cm G 13 0 1 Source Ultrasound in Gynaecology and Obstetrics Textbook and Atlas Thieme Medi cal Publishers Inc New York 1991 7 84 SIGMA 110 SIGMA 330 15 10 01 H 4 KONTRON HINMEDICAL Appendix H Radiology Study H 1 Description 14 03 01 08 30 31 ABDO 2D STUDIE VOLUMES labell label2 CARDIAC OUTPUT Coeff coeffl coeff2 di cm Diam cm d2 cm d3 cm CONTINUITY EQUATION EV cm3 Diaml cm VOLUMES label3 label4 Coeff coeff3 coeff4 dl d2 cm d3 cm EV cm3 _ PAEDIATRICS STUDIES HIP ANGLES Alpha dg Beta dg a Volumes Volume label user defined 11 label2 label3 label4 Coeff user defined coeff1 coeff2 coeff3 coeff4 d1 Distance 1 in cm d2 Distance 2 in cm d3 Distance 3 in cm Volume cm3 Volume label and related coefficient can be defined by user By default the system uses the following values Default Name Default Coeff label1 Ellipse 0 5
121. 7 V and 200 240 V Mains frequency 50 60 Hz Consumption 340 ELECTROMAGNETIC FIELD Maximum field strength without degradation of performance 1 V m 1 7 14 Regulalion and Safety CE MDD mark e German regulation EC 601 1 Class 1 Type B Electrical Safety EC 1157 Acoustic power reporting FDA 510 k 15 10 01 INSTRUMENT DESCRIPTION 1 51 4 KONTRON MEDICAL 1 7 15 Dimensions e Height 380 mm e Width 470 mm Depth 526 mm Weight 29 kg 1 52 SIGMA 110 SIGMA 330 15 10 01 1 8 SIGMA 330 Technical Specifications 1 8 1 General The SIGMA 330 is a 2D TM Spectral Doppler and Color Flow Mapping ultrasound scanner for general purpose applications Abdominal Breast Cardiology Emergency Endocrinology Gastro enterology Gynaecology Musculoskeletal Neonatology Obstetrics Paediatrics Small parts Urology Vascular SCANNING TECHNIQUES Electronic linear scanning Electronic convex scanning e Annular array sector scanning Doppler Pencil Probes DISPLAY MODES Real time 2D B Mode display modes Single 2D format Double 2D format Quad 2D format 2D panoramic zoom for AS probes only 2D scroll zoom for LINEAR CONVEX probes only 2D magnification 3p 3D Fetal View 3D Vascular View TM M Mode display modes Quasi Duplex 2D TM 2D 50 screen TM 50 screen Full screen
122. 82 Zsp cm 3 54 8 deq Zsp cm 0 38 fe MHz 4 10 4 10 2 x cm 1 28 1 28 Im O 2 090 0 90 PD msec 10 22 10 22 6 Hz p Pllmax 5 deq Plimax 0 37 FL cm 3 95 Len E 2 FL om 95 IpA 3Mlmax W cm application Vasc Vasc 5 Doppler frequency MHz 4 4 gate size mm 8 8 velocity range kHz 3 2 3 2 energy dB 0 0 Notes a This index is not required for this operating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is not reported for the reason listed 15 10 01 APPENDICES 7 131 4 KONTRON MEDICAL Transducer Model 5 0 LV Operating Mode Color Flow Doppler TIS TIB TIC non scan Index Label MI non Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value a 2 0 Pr 3 MPa 2 Wo1 mW 87 5 E min of W 3 21 21 mW 21 cm z A 2 2 zm E Zsp cm 5 9 deq Zsp cm 2 fc MHz 4 88 lize 1 28
123. 89 1969 based on the average sac diameter in three dimensions 7 76 SIGMA 110 SIGMA 330 15 10 01 G 9 3 GES from Hansmann GES from Hansmann EBD week EBD week 4 EBD week 1 5 2 GES 6 9 3 1 Source Dr Hansmann Ultraschalldiagnostik in Geburtshilfe und Gyn kologie page 39 Springer Verlag ISBN 3 540 11428 9 15 10 01 APPENDICES 7 77 H 4 KONTRON MEDICAL G 10 Abdominal Circumference AC G 10 1 AC from Hadlock AC from Hadlock EBD week W EBD week d4 amp EBD week AC cm G 10 1 1 Source Hadlock R L Deter R B Harrist S K Park Fetal Abdominal Circumfer ence as a Predictor of Menstrual Age Am J Roentgenology 139 367 1982 7 78 SIGMA 110 SIGMA 330 15 10 01 G 10 2 AC from Merz AC from Merz EBD week W EBD week EBD week AC cm G 10 2 1 Source Ultrasound in Gynaecology and Obstetrics Textbook and Atlas Thieme Medi cal Publishers Inc New York 1991 15 10 01 APPENDICES 7 79 AVA KONTRON MEDICAL G 10 3 AC from Lai Yeo AC cm EBD week 9 6 15 8 0 8 14 5 20 0 1 0 19 9 25 0 1 2 22 0 27 0 1 4 23 0 28 0 1 5 23 9 29 0 1 4 25 9 31 0 1 7 28 6 34 0 2 0 30 3 36 0 2 1 32 3 38 5 2 5 AC from Lai Yeo 10 0 15 0 20 0 25 0 30 0 AC cm EBD
124. 9 4 Transfer data to Sono Win Once relevant data have been stored on the PCMCIA SRAM the transfer can be done As previ ously mentioned Sono Win supports two modes of operation data transfer via PCMCIA SRAM card or via USB cable connection 3 19 4 1 Transfer via a PCMCIA SRAM When this operating mode is used the SRAM must be inserted in the PCMCIA drive located on the computer When Sono Win is running the system reads the relevant data on the card and the KIPRISM data are automatically stored in the correct Sono Win records When the PCMCIA SRAM is inserted again in the SIGMA the memory card content is automatically erased Note that if certain measurements cannot be assigned automatically to Sono Win measurement records e g in case of user defined measurements the assignment can be performed manu ally Please refer to SonoWin 2000 User s Manual 3 19 4 2 Transfer via a USB connection This operating mode is based on a USB cable connection between the ultrasound device and the computer Unlike the operating mode described above the SRAM card remains in its drive on the ultrasound device all the time There are several ways to start a transfer from the SIGMA to Sono Win press on the Transfer key in any freeze menu The data currently stored on the memory card are transferred to Sono Win 3 106 SIGMA 110 SIGMA 330 10 12 01 AVA HA MEDICAL a start a new patient study press on the new p
125. A 110 Light Master and SIGMA 330 Master a only for SIGMA 330 Master b when USB Link option is installed o MS EIS lt gt gt j i m lP Pm5imnmi L m 2 4 SIGMA 110 SIGMA 330 10 12 01 Ref Designation 100 250 250 ml bottle of ultrasound gel 411 353 Power cable EURO D CEE 22 487 848 Power cable North American Hospital Grade for US 477 729 Memory card 4 MB SRAM PCMCIA 484 164 Memory card label DOC31001EN Operator Manual English according to system language 462 489 Medical Ultrasound Safety Guide for US only DOC31001FR Operator Manual French according to system language DOC31001GE Operator Manual German according to system language DOC31001IT Operator Manual Italian according to system language DOC31001SP Operator Manual Spanish according to system language DOC31001CY Operator Manual Russian Cyrillic according to system language 483 184 Remote control Unit English according to system language 483 176 Remote control Unit French according to system language 483 168 Remote control Unit German according to system language 483 141 Remote control Unit Italian according to system language 483 133 Remote control Unit Spanish according to system language 483 125 Re
126. A 330 15 10 01 Appendix Report Menu The meaning of the icons present in the different report menus are explained hereunder Select a new medical application Go to next page Go to previous page PPh Reset the selected field to zero View the selected ObGyn curve View printable report preview Start a new study erase all the biometry fields Display setup screen for ObGyn Validate the user s choice on the displayed 5 Exit current sheet Return to the previously displayed sheet Print the report on the printer Save the report on the flashcard By pressing the icon the user changes the medical application This modification concerns only the biometry study the medical application of the probe does not change After this operation a new biometry page according to the current medical application is proposed The 2 1 icon is only displayed when the current medical application study has more than one page Pressing on this key displays the next page of the study Note the report sheets are organized as a circular list first page L last page 15 10 01 APPENDICES 7 5 last page first page The lt A icon is used in the print preview menu Pressing on this key displays the previ ous page of the study When the first page or the last page is displayed the following rule is applied first page lt last page last page L fi
127. APD sss 7 69 G 8 Crown Rump Length CRL ta e te 7 71 G 9 Gestational Sac GES Me ect ect teste pln RR 7 76 G 10 Abdominal Circumference 7 78 9 11 Head Circumference 7 81 G 12 Binocular Distance BOD from Jeanty 7 84 G 13 Occipital Frontal Diameter from Merz 7 84 Appendix Radiology 7 85 Hs Description 7 85 abate ot Y cn DOR SES RD ins aaa eel 7 86 Appendix Measurement Interface 7 89 1 Doing a Measurement from Report 44 4 42 7 89 12 Importing Measurements in Report 4 4 221111 222 7 91 Appendix J Print 1 7 93 J 1 Editthe Printable Report saos eM om cta ne 7 93 TABLE OF CONTENTS xiii 10 12 01 H 4 KONTRON HAW MEDICAL 4 22 Print the Report an External Printer 200 1 7 94 J 3 Save the Report on a Flashcard 7 94 Appendix K KIPRISM SonoWin Basic Conversion Tables 7 95 niti
128. Annular Sector Probes Connector for Doppler Pencil Probes Connector panel 1 26 Figure 1 12 SIGMA 110 Light Master and SIGMA 330 Master rear panel SIGMA 110 SIGMA 330 15 10 01 1 3 5 4 Connector Panel CO 2 3 4 5 6 CO 8 9 9 19 2 Figure 1 13 Connector panel Before connecting any equipment to these connectors read carefully Chapter Ill 1 Intended Clinical Use on page xv and Chapter 2 Safety Information page xviii Service connector Video printer 2 remote control Video printer 1 remote control Remote Power Switch Line Printer parallel Port Serial Interface COM1 ECG Keyboard USB Port 9 Monitor 10 Video printer 11 SVHS VCR amp Audio Input Output 12 Foot switch o OY ao 15 10 01 INSTRUMENT DESCRIPTION 1 27 AVA KONTRON MEDICAL 1 4 System Controls Definition of the control keys shown in figure 1 4 Keyboard on page 1 13 1 4 1 Alphanumeric Keys Alphanumeric keys access to all upper case characters Useful graphic characters are accessed with using of the SHIFT key 1 4 1 1 ESC Key The ESCape key is a generic key that leaves any menu and return to the previous one aborts any string entry and restore the previous one if possible is available as often as possible to give user possibility to correct its manipulation errors aborts current measurement returns to previous study sheet or exits report when firs
129. CO l mn LV SIMPSON 2D RVDd cm gt CI 1 mn m2 SAAld cm2 IVSd cm gt SAA2d cm2 LVDd cm AALd cm PLVWd cm LEFT VENTRICLE 2D SAA1s cm2 IVSs ocm ALd cm SAA2s cm2 LVDs cm LAAd cm2 AALS cm PLVWs cm ALs cm VOLd cm3 LVET s LAAs cm2 VOLs cm3 VOLd cm3 VOLd cm3 EF VOLs cm3 VOLs cm3 SV m1 SF EF SI ml m2 LVM g SV ml CO l1 mn LVMI g m2 SI ml m2 CI l1 mn m2 VCF circ s CO 1 mn gt 5 CI l1 mn m2 HEART RATE SV m1 HR b mn SI ml m2 15 10 01 H 4 KONTRON HIN MEDICAL LVDd Left Ventricle Diameter at diastole in cm PLVWd Posterior Left Ventricular Wall at diastole in cm 1 55 Inter Ventricular Septal Thickness at systole cm LVDs Left Ventricle Diameter at systole in cm PLVWs Posterior Left Ventricular Wall at systole in cm LVET Left Ventricle Ejection Time in second gt VOLd Diastolic Volume Teichholz formula in cm3 gt VOLs Systolic Volume Teichholz formula in cm3 gt SF Shortening Fraction in percent gt LVM Left Ventricle Mass in grams gt LVMI Left Ventricle Mass Index in grams per square meters gt VCF Velocity of Circumferential Fibre Shortening in circumference per second gt EF Ejection Fraction in percent gt SV Stroke Volume in millilitres gt 51 Stroke Volume Index in millilitres per square meters gt CO
130. C_SD Uncertainty on foetal age estimated from HC HC WEK OG2DCHC WEK Foetal age estimated from computed HC OG2DHC_WEK Foetal age estimated from HC eas LVTMIVd_IVS Inter ventricular septum thickness at diastole LVTMIVs_IVS Inter ventricular septum thickness at systole AV2DMVA Mitral valve area mn MVPHT_Area Mitral valve area computed from PHT PEP AVSPPEP Aortic valve pre ejection period SP meas AVTMLPP Aortic valve pre ejection period TM meas OGSPPIC_VelS VelD Ratio syst diast velocity medial cerebral artery computed on 15 10 01 OGSPRIC VelS VelD Ratio syst diast velocity medial cerebral artery computed on RI APPENDICES 7 109 SonoWin Item SIGMA value Description OGSPPIU VelS VelD Ratio syst diast velocity umbilical artery computed on PI S D AUM 3 OGSPRIU VelS VelD Ratio syst diast velocity umbilical artery computed on RI S D OGSPPIL_VelS VelD Ratio syst diast velocity uterine artery left computed on OGSPRIL VelS VelD Ratio syst diast velocity uterine artery left computed on PI S D AUT OGSPPIR VelS VelD Ratio syst diast velocity uterine artery right computed on PI r a OGSPRIR VelS VelD Ratio syst diast velocity uterine artery right computed on RI s AVOTSV SI Stroke volume index computed on left ventricle output trunk AVSPSV SI S
131. Card D Aortic Valve Description SIGMA Sono Win Chapter Pulmonary Artery Diameter SP measures Description PAD cm PAD mm Sono Win Card D Pulmonic Valve Chapter Velocity Time Integral VTI Card D Pulmonic Valve Peak Velocity Vpeak calc Card D Pulmonic Valve Peak Gradient peakPG calc Card D Pulmonic Valve Mean Gradient meanPG calc Card D Pulmonic Valve Right Ventricle Pre Ejection Period PEP ms Card D Pulmonic Valve Stroke Volume ml SV ml Card D Pulmonic Valve Stroke Volume Index ml m2 SI ml m2 Card D Pulmonic Valve Cardiac Output l min CO l min Card D Pulmonic Valve Cardiac Output Index K 2 4 2 Tricuspid Valve TM measures 2 2 D Pulmonic Valve Description SIGMA Sono Win Chapter Slope between D and E wave SP measures Description DEsl cm s SIGMA RV_DESLP Sono Win mm s Card M MV and Aorta Chapter Tricuspid Regurgitation Velocity TRV m s Reg_V m s Card D Pulmonic Valve Right Ventricular Right Atrial Gradient RVRAGr mmHg peakPG K 2 4 3 Continuity equation Free measurement 2D measures Description Sono Win mmHg Card D Pulmonic Valve Chapter Diameter DIAM mm Card D Pulm
132. Chapter Diameter 1 Diam mm Angio Doppler Auto Trace Area 1 AREA1 SIGMA 110 SIGMA 330 Angio Doppler Auto Trace 15 10 01 5 4 Hip Angles Description SIGMA SonoWin Chapter Alpha angle Alpha angle degrees Alpha degrees Pediatrics Type of the Alpha angle UH the Alpha TypeForAlpha Pediatrics Beta Angle Beta Angle degrees Beta degrees Pediatrics Type of the Beta angle ae TypeForBeta Pediatrics K 6 Multiple associations Sometimes several SIGMA data are assigned to the same SonoWin data It is the user s responsibility to choose which one will be used Sono Win Item SIGMA value Description OG2DAC Abdominal circumference dd OG2DCAC Computed abdominal circumference AG Sp OG2DAC SD Uncertainty on foetal age estimated from AC B OG2DCAC SD Uncertainty on foetal age estimated from computed AC AGANEK OG2DAC_WEK Foetal age estimated from AC i OG2DCAC WEK Foetal age estimated from computed AC Ci AVOTCO COI Cardiac index AVSPCO COI Cardiac index AVOTCO CO Cardiac output s AVSPCO CO Cardiac output ANCEQ D Diameter for Continuity Equation ANDIA Diameter for Continuity Equation AV2DMVD Diameter DIAM MVCE D Diameter MVD Diameter OG2DCHC Head circumference e OG2DHC Head circumference uc Sp OG2DCHC SD Uncertainty on foetal age estimated from computed HC OG2DH
133. D FML HuL AC HC ki le Lu Second function keys page LMP Last Menstrual Period EBD Estimated Birth Date NWA Number of Weeks of Amenorrhea CRL Crow Rump Length in cm GES Gestational Sac in cm ChD Chorion Diameter in cm BPD Biparietal Diameter in cm BOD Binocular Distance in cm OFD Occipital Frontal Diameter in cm 15 10 01 APPENDICES 7 37 H 4 KONTRON HAN MEDICAL HC Head Circumference in cm TAD Transabdominal Diameter in cm APD Anterior Posterior Diameter in cm AC Abdominal Circumference in cm THD Thoracic Diameter cm FML Femur Length in cm HuL Humerus Length in cm Abdominal Circumference Calculated cm HC Head Circumference Calculated in cm Cephalic Index BPD OFD percentage AEHC AC Head Circumference Abdominal Circumference AEFML AC Femur Length Abdominal Circumference amp FML BPD Femur Length Biparietal Diameter WEIGHT Foetal Weight in kg Uncertainty in kg AUA Average Ultrasound Age in week AEBD Average Estimated Birth Date F 1 2 Equations Estimated Foetal Age Age and uncertainty For each kind of measurement BPD FML the foetal age and its uncertainty are esti mated according to Ob Gyn curves For more details on Ob Gyn curves see Appendix 4 Setup Sheet on page 7 44 Estimated birth date EBD EBD D LMP 0280 days LMP Last Menstrual Period Numbers of Weeks of Amen
134. FERENCES Archive mode press MENU NEXT the screen is changed as shown below a popup menu is displayed on the right showing all reports present on the flashcard and the key information stored in the selected report text file is displayed on screen Patient name SMITH Delete Del All Undo Report Reports gt 3 56 SIGMA 110 SIGMA 330 10 12 01 H 4 KONTRON HAINMEDICAL a The third menu key is used to delete a report When the user presses it a dialogue box for confirmation is then displayed and the report text file is deleted if the user selects Yes Do you really want to delete SMITH TXT file Yes No a The fourth key is used to delete all reports stored on the flashcard When user presses it a confirmation dialogue is displayed Do you really want to delete all reports Yes No a The fifth key is used to Undo the deletion of reports It restores all deleted reports This key is disabled if no items have been deleted Remark the Undo action is impossible after Archive mode exit 3 11 4 6 Patient As above mentioned Chap ter 3 11 2 1 Panels of 16 27104100 10 53 35 PATIENT INFORMATION Images on page 3 52 the Laboratory SAINTE ANNE 2 mode entered when press P un Undefined POSS Operator oe 1 5 GR PATIENT REFERENCES ao 2 u i Undefined Thumbnails mode and the potent na
135. FY key once more or 2D to return to the normal format The graphic symbol below shows that the image is magnified Q The magnification function works equally well on live images and frozen ones NOTE Magnify can use a zoom factor up to 6 dependent on the different probes 3 50 SIGMA 110 SIGMA 330 10 12 01 3 11 Digital Archiving KIPRISM The SIGMA 110 and SIGMA 330 systems include the KIPRISM features which allows the user to store ultrasound images report and patient information on Memory Cards SRAM flash cards The KIPRISM logo is displayed on the bottom left of the SIGMA Start up screen KIPRISM allows displaying and storing images in thumbnail format as well as full screen format on a memory card The memory card can be read by any PC equipped with a recommended PCMCIA driver refer to Chapter 2 9 3 Archiv KIPRISM ing on Personal Computer on page 2 17 All selections can be done with the trackball and the three associated SET keys KIPRISM features a a a a 3 11 1 report printout user interface for images multi patient environment multi images Thumbnails presenta tion with calibration information image storage and restore from memory cards user interface for report store report and patient information Display report preview and report sheets from the memory card DICOM compatibility used for EasyPrint printing images with connected inkjet printer Image Storage and Freeze M
136. GP 5 0GP 7 5GP 14PV PEN2 PEN4 PEN8 TCD2 n n GP PV Figure 4 2 Immersion limit of Annular Sector and Pencil probes 1 Cidex is a Trademark of Johnson amp Johnson 10 12 01 MAINTENANCE 4 5 4 6 SAVATG ZL Figure 4 3 Immersion limit of Linear Convex probes SIGMA 110 SIGMA 330 10 12 01 6 5MR 6 5VMC 6 5EV E gt gt EH Figure 4 4 Immersion limit of endocavitary probes 10 12 01 MAINTENANCE 4 7 4 HA MEDICAL 4 3 Repairs and Maintenance The SIGMA 110 330 system is designed to be maintained by factory trained Customer Service Representatives The manufacturer assembler installer or importer considers himself responsible for the effects on safety reliability and performance of this product only if e Assembly operations extensions readjustments modifications or repairs are carried out by personnel authorized by the Manufacturer e The electrical installation of the facility where the product is used complies with the IEC requirements or Electrical Codes of the country e The product is used in accordance with the instructions of use 4 3 1 User Maintenance The user of SIGMA 110 330 units can do some maintenance by himself 4 3 1 1 Air filter replacement Depending on the system configuration and on the environmental conditions it is necessary to replace the air filter more or less regularly
137. Gr Right Ventricular Right Atrial Gradient mmHg 0 4 2 2 Continuity Equation Free Measurement a 2D measurements Diam Diameter in cm gt 1 Area 1 in cm2 computed from Diam1 b SP measurements VTI1 Velocity Time Integral 1 in cm VTI2 Velocity Time Integral 2 in cm gt AREA2 Area 2 cm2 computed from VTI1 and 2 Vel1 Velocity 1 in meters per second Vel2 Velocity 2 in meters per second gt AREA2 Area 2 in cm2 computed from VEL1 and VEL2 D 4 2 3 Heart Rate SP or TM Measurement HR Heart rate in beats per minutes on right ventricle This field is used for the computation of the right ventricle study sheet D 4 3 Equations 0 4 3 1 Pulmonic Valve Velocity Time Integral VTI in cm VIC Vj At v D 2 fo COSA Vi Velocity in m s during each Dt in s of measured spectral area Df Doppler frequency in Herz C Sound velocity 1540 m s 10 Ultrasound frequency Herz a Angle between the ultrasound beam and blood velocity e Pressure Time Integral in seconds per mmHg PTI PTI P At P Dav Pi Pressure in mmHg during each Dt in s of the velocity spectrum 15 10 01 APPENDICES 7 27 Computed from simplified Bernouilli equation V Velocity in m s Mean Gradient in mmHg MnG MnG D EU Time PTI Pressure Time Integral Time Duration flow in seconds Pressure Half Time in millisecond PHT PHT D PV a 0 707 PV Peak Velo
138. Gyn extensive measurements capabilities including BPD FML CRL BOD ABD THD AC GES HC OFD APD TAD Foetal Weight Estimated Birth Date e Cardio left ventricular volumetry using Simpson area length single and bi plane formu las systolic and diastolic volume using Teichholz rule shortening fraction myocardial mass and mass index left ventricular circumference ejection fraction cardiac output and index stroke volume and index mean velocity pressure and mean pressure gradi ent pressure half time and valve area time to peak velocity in systole right and left ven tricular ejection time and pre ejection period right ventricular systolic pressure continuity equation QP QS All applications body surface area BSA ME ASUREMENT ACCURACY Parameters Typical accuracy e Distance lt 3 1 mm when 3 of the measured value is less than 1 mm e Angle lt 2 5 e Distance e lt 1 0 5 mm when 1 of the meas ured value is less than 0 5 mm 1 lt 2 Speed lt 5 of max displayed velocity Frequency 5 of max displayed frequency e Gradient lt 10 e Time lt 1 Acceleration lt 10 e Velocity 10 of the velocity range Frequency 10 of the frequency range Heart rate computed by ECG 1 bpm Table 1 6 Measurement Accuracy 1 8 14 Acoustic Power The acoustic power depends on M
139. H 4 KONTRON IMAGING SIGMA 110 SIGMA 330 Operator Manual Software Version V 5 XX O Copyright by KONTRON MEDICAL 2001 Ref DOC31001EN Issue date 10 12 01 Issue 4 15 10 01 GENERAL INFORMATION GENERAL INFORMATION SIGMA 110 SIGMA 330 15 10 01 l Copyright 2001 by KONTRON MEDICAL SAS ALL RIGHTS RESERVED PRINTED IN FRANCE The information contained in this publication may not be used for any purpose other than that for which it was originally supplied The publication may not be reproduced in part or in whole with out written consent of KONTRON MEDICAL SAS In order to maintain and improve standards of manufacturing methods of functioning and reliability KONTRON MEDICAL SAS equipments are periodically reviewed For this reason the content of this publication is subject to change without any notice This product contains KONTRON MEDICAL proprietary software in machine readable form KONTRON MEDICAL SAS retains all its rights title and interest in the software Purchase of this product includes a license to use the software contained in it The purchaser shall not copy trace disassemble or modify the software nor cause or allow this software to be copied traced disas sembled or modified Transfer of this product by the purchaser will constitute a transfer of this license which will not be transferable otherwise The equipment described is manufactured by KONTRON MEDICAL S A S Boite Postale 97
140. HEART Ob Fet 1 K 4 2 2 Velocity and Frequency measurement Description Sono Win Velocity Velocity Frequency lt normal gt lt super q y Frequency kHz script gt a lt normal gt a This SIGMA measure is not assigned to a variable in SonoWin The user has to assign it manually to SonoWin parameter K 4 2 3 Resistance and Pulsatility Index e Uterine Left Artery Description SIGMA Sono Win Chapter Pulsatility Index PI PI AUT I Ob Fet 1 Mean Velocity TAMX VTAMX AUT I Ob Fet 1 Velocity at Systole Vels Vsyst_AUT Ob Fet 1 Velocity at Diastole Veld Venddiast AUT I Ob Fet 1 Ratio Velocity Systole Diastole Vels Veld S D AUT Ob Fet 1 Resistance Index RI RI AUT I Ob Fet 1 Velocity at Systole Vels Vsyst AUT Ob Fet 1 Velocity at Diastole Veld Venddiast AUT I Ob Fet 1 Ratio Velocity Systole Diastole Vels Veld S D AUT Ob Fet 1 7 106 SIGMA 110 SIGMA 330 15 10 01 Uterine Right Artery Description SIGMA Sono Win Pulsatility Index PI PI AUT r Ob Fet 1 Mean Velocity TAMX VTAMX AUT r Ob Fet 1 Velocity at Systole Vels Vsyst_AUT r Ob Fet 1 Velocity at Diastole Veld Venddiast_AUT r Ob Fet 1 Ratio Velocity Systole Diastole Vels Veld S D_AUT r Ob Fet 1 Resistance Index RI AUT r Ob Fet 1 Velocity at Systole Vels Vsyst_AUT r Ob Fet 1
141. KIPRISM 1 7 6 ECG Module option 1 7 7 EasyPuntIM rre 1 7 8 USB LINKTM i inb eia eheu 1 7 9 Peripherals Optional 1 7 10 506 1 7 11 1 7 12 Acoustic 1 7 13 EAVIFONMEN cove 1 7 14 Regulation and Safety Live Investigation Keys TABLE OF CONTENTS vii H 4 KONTRON HAW MEDICAL Treo aioe E NEA ees tuna N EAA NEES SEA E 1 52 1 8 SIGMA 330 Technical Specifications 1 53 Tid OBS ecd Echo tn ice fede E A fede feat eunt 1 53 1 8 2 2DBSMOGG tn atta rr eire baa tuuc ku 1 55 1833 TM MENOS nene taxa OR Ran Fata basa a 1 56 1 8 4 Spectral Doppler Mode bai n es ep ico so Eco lub oH 1 56 1 8 5 Colour Doppler Modes iere Fu Epi PUR get ies 1 58 18 67 SD Imatirig pter cela bed ride 1 58 1 8 7 Digital Archiving n vec a tai lues 1 59 1 8 8 ECG Module option cod baa Race Cae Ru 1 59 To dern sss ad o c uia pee Leg 1 59 DESDE sp TTE 1 59 1 8 11 Peripherals Optional nied ent do pt odes 1 60 MPLS OUTIL Eq
142. KONTRON HAN MEDICAL IVSDd Inter Ventricular Septal Thickness at diastole PLVWd Posterior Left Ventricular Wall at diastole LVDd Left Ventricle Diameter at diastole D 1 2 3 Left Ventricle Study Simpson e End Diastolic Volume cm3 VOL d VOLd D sAA140 EAM 58 3 2 SAA1d Short Axis Area 1 at diastole in cm2 SAA2d Short Axis Area 2 at diastole in cm2 LALd Long Axis Length at diastole in cm e End Systolic Volume in cm3 VOLs VOLs D SAAis 0 E83 2 5 15 Short Axis Area 1 at systole cm2 SAA2s Short Axis Area 2 at systole in cm2 LALs Long Axis Length at systole in cm Ejection Fraction in percent EF Er pVOLd VOLS 10 VOLd 9 VOLd End diastolic Volume in cm3 VOLs End systolic Volume in cm3 e Cardiac Output in litres per minute CO SV HR 1000 SV Stroke Volume in millilitres HR Heart Rate in beats per minute Cardiac Output Index in litres per minute per square meters CEDE BSA CO Cardiac Output in litres per minute BSA Body Surface Area in m2 Stroke Volume in millilitres SV SvDvoLd VOLs VOLd End diastolic Volume in cm3 VOLs End systolic Volume in cm3 15 10 01 APPENDICES 7 17 Stroke Volume Index in millilitres per square meters 51 D SV 2 BSA SV Stroke Volume in millilitres BSA Body Surface Area in m2 D 2 Mitral Valve Study D 2 1 Description 14 01 98 08 30 31 LAB a
143. L D 3 Aortic Valve Study D 3 1 Description 14 01 98 08 30 31 Izd ute es e yere e io Veivenene love yu u e Te tence m crc NAME 95 OCDE EXAM Nieeeee SEX H cm W kg AGE y BSA m2 HR b mn CARDIOLOGY STUDIES AORTIC VALVE AORTIC VALVE 2D AORTIC VALVE TM LVOT SP AVD cm AoD cm cm AVA cm2 LAD cm PkV m s AORTIC VALVE SP AVO cm PkG mmHg cm LVET s MnG mmHg PkV m s LVPEP s SV m1 PkG mmHg LAD AoD SI ml m2 MnG mmHg LVPEP LVET CO 1 mn PHT ms CI l1 mn m2 LVPEP s HEART RATE AORTIC VALVE EOA SV ml HR b mn LVOTD cm SI ml m2 LVOTA cm2 CO l1 mn LVOT 2D VTIlvot cm gt CI 1 mn m2 LVOTD cm VTIao em DESCENDING AORTA SP LVOTA cm2 gt cm2 VTIs Vivot m s VTId cm Vao m s gt gt 2 oml m D 3 2 Aortic Valve a 2D study AVA Aortic Valve Area in cm2 AVD Aortic Valve Diameter in cm b SP study VTI Velocity Time Integral cm PkV VTI Peak Velocity in m s PkG VTI Peak Gradient in mmHg MnG VTI Mean Gradient in mmHg PHT Pressure Half Time in millisecond LVPEP Left Ventricle Pre Ejection Period in second gt SV Stroke Volume in millilitres gt 5 Stroke Vo
144. Link In this case data stored on the flashcard are imported and processed by the PACS For more information about the PACS software refer to the User Manual of the PACS software delivered with the sys tem Please contact your local KONTRON MEDICAL representative for information about supported PACS 3 18 7 Limitations Only read accesses are allowed In consequence the following are forbidden from the computer no flashcard format no file can be modified or deleted no file can be created or copied no file can be renamed no directory can be created The flashcard organization must be solely managed by the SIGMA If one of the above listed actions are done anyway then the SIGMA will not recognize these data and the PACS may not import them Therefore the flashcard must be formatted from the SIGMA saved data are then lost The user will be responsible to preserve the flashcard content no changes must be done from the computer only read and copy operations are allowed All the files the SIGMA writes on the flashcard are read only But if the user intends to modify or delete a file the Operating System just warns him that the file is write protected but the user can delete or modify it anyway 3 102 SIGMA 110 SIGMA 330 10 12 01 AVA MEDICAL 3 19 Sono Win Lite and Sono Win Basic PACS 3 19 1 Overview 3 19 1 1 SonoWir Lite SonoWin Lite PACS software offers the following features
145. MA 110 SIGMA 330 15 10 01 1 31 Electronic Cabinet The electronic cabinet includes the required circuitry to perform complete functions Power Supply a Processor which controls the main system functions and the user interface a Transmitter receiver modules for both linear convex and sector transducers a Scan Converter a Digital processing and filtering a Spectral Doppler a Colour Flow Mapping 1 3 2 Control Panel The Control Panel is connected to the main electronic board through a serial line Its ergonomics allows the user to communicate easily with the system The keyboard includes a backlight that allows the system to be used in semi darkness The Control Panel includes 23 function keys 10 menu function keys Their current functions are displayed on the corresponding MENU on the screen 1 incremental potentiometer softpot Its current function is displayed in the correspond ing MENU on the screen 1 potentiometer for 2D or TM gain adjustment 1 potentiometer for spectral gain adjustment in CFM PW and CW e 1 potentiometer for depth selection 5 sliders rectilinear potentiometers for gain equalization 1 alphanumerical keyboard with standard upper case characters and useful graphic characters 1 trackball with corresponding function keys e 1 Power ON OFF button 1 Remote control 15 10 01 INSTRUMENT DESCRIPTION 1 11 AVA KONTRON MEDICAL 1 3 2 1 Keyboard The controls locat
146. MA 330 10 12 01 3 4 Menus Menus are used to access functions or parameters There is a specific menu for each mode for setups and for processing features settings see mode selection chapters in Chapter 3 7 Major Modes on page 3 25 The menus are displayed in gray The inside text is displayed in black if the menu button is selected and in white if not 3 4 4 Notes The following syntax is used in this document to describe the formats XX YY describes a dual format with pad XX being active 3 4 2 Menu Key Conventions As a general convention the menu keys are always displayed in the same place independent of the modes A menu key can be enabled disabled or not available If a menu key is disabled it is drawn ghosted If it is not available it is not drawn at all The following rules are used to distinguish between disabled and not available menu keys a If the functionality represented by the key is enabled in one mode but doesn t work in an other mode the key is disabled in the other mode a If the functionality is never enabled any mode it is not available and so not displayed a Exceptions which will improve the user interface are introduced 3 4 8 Menu Types Two different types of menus can be displayed according to whether the current application is single or double A Single Menu consists of one Menu Item row that can contain two character lines see figure 1 16 Single Menu Display on page 1 36
147. Modes Depth change Power ON OFF Baseline shift in PW CW and CFM mode Freq in 2D frequencies in PW CW and CFM Velocity in PW CW and CFM modes CW mode switch Equivalent to PRINT1 on the keyboard Mode switch 2D gain in 2D SP gain in Doppler CFM gain in CFM The 3 keys SCROLL SP BASELINE and VELOCITY access directly to the corresponding Dop pler parameters described in Chapter 3 7 3 2 PW Live Menu on page 3 36 For changing the selected parameter use and keys 1 14 SIGMA 110 SIGMA 330 15 10 01 For example to modify the scroll speed 1 Press SCROLL SP key to select the parameter 2 Press key to decrease the scroll speed or press key to increase it The DEPTH key accesses directly to the corresponding 2D parameter described in Chapter 3 7 1 2 2D Live Menu on page 3 28 For changing the parameter proceed as described above MAGN and FREQ are toggle keys described in Chapter 3 7 1 2 2D Live Menu on page 3 28 In PW CW mode FREQ corresponds directly to the frequency item displayed in the Doppler Menu on screen described in Chapter 3 7 3 2 PW Live Menu on page 3 36 and Chapter 3 7 4 2 CW Live Menu on page 3 41 The GAIN key modifies the overall gain according to the active mode Press the left side of the key to decrease the gain or press the right side to increase it The trackball function of the control panel is replaced by 4 arrows and a button located in the
148. NS 3 9 M Dual Zoom Freq Biopsy 1 Le on oM Right Tilt Trigg 1 3 10 SIGMA 110 SIGMA 330 10 12 01 3 5 Probes 3 5 1 Probe Selection Press the PROBE key to display the Probe Menu This menu shows the names of the probes that are connected to the system Up to 5 probes can be simultaneously connected to SIGMA 330 Expert including Doppler function and SIGMA 330 Excellence 4 probes for SIGMA 110 Mas ter and SIGMA 330 Master models including Doppler option and 3 probes for the SIGMA 110 Light including Doppler option a Two Linear Probes or Convex Linear Probes one Doppler Probe Pencil Probe and two AS probes for SIGMA 330 Expert and SIGMA 330 Excellence One Linear Probe or Convex Linear Probe one Doppler Probe Pencil Probe and two AS probes for SIGMA 110 Master and SIGMA 330 Master Two Annular Sector probes and one Doppler probe pencil probe for SIGMA 110 Light The following drawing shows the probe menu with 4 probes connected The probe which is selected by default when switching the instrument on can be determined by the user via the Setup menu Pressing F2 softkey selects the probe connected to connector P 3 e g 5 0 GP P 2 P 3 4 P 1 3 5 GP 5 0 GP PEN 2 7 5 LV CA When selecting Probe the system looks for a setup for this probe First priority search is user setup second priority search is factory setup 3 5 2 Menu Display
149. Options 450 847 Cine Mode Option 483 281 ECG Option including set of clamp electrodes 483 311 Spectral Doppler Option 472 204 Bolero Cart Option 483 184 IR Remote Control Unit Option ENG 483 176 IR Remote Control Unit Option FRE 483 168 IR Remote Control Unit Option GER 483 141 IR Remote Control Unit Option ITA 483 133 IR Remote Control Unit Option SPA 483 125 IR Remote Control Unit Option CYR 481 068 Footswitch 482 765 Ext Switch box for Master 485 926 Ext Switch box for Bolero Cart 486 523B EasyPrint Black amp White 488 852 USB Link option 487 260 VHS option 486531EN 486531GE 486531FR 486531SP SonoWin Lite English German French Spanish version 488798EN 488798GE 488798FR 488798SP SonoWin Basic English German French Spanish version 486 345 Table 6 1 SIGMA 330 Options Flat LCD 15 screen repetition monitor Holder Kit SIGMA 110 Options 480 908 Colour Flow Mapping Option 483 281 ECG Option including set of clamp electrodes 481 068 Footswitch 482 765 Ext Switch box for Master 485 926 Ext Switch box for Bolero Cart 486 523 EasyPrint Color 488 852 USB Link option 487 260 VHS option 486728EN 486728GE 486728FR 486728IT 3D FetalView English German French Italian vers
150. PPENDICES 7 69 AVA KONTRON MEDICAL G 7 3 APD from Merz APD from Merz EBD week W EBD week dk EBD week 6 APD cm 6 7 3 1 Source Ultrasound in Gynaecology and Obstetrics Textbook and Atlas Thieme Medi cal Publishers Inc New York 1991 7 70 SIGMA 110 SIGMA 330 15 10 01 G 8 Crown Rump Length G 8 1 from Robinson CRE ey EBD week 5 U 7 9 RD NM REEL RON 10 77 97 54 07 08 from Robinson EBD week EBD week 4 amp EBD week 4 CRL cm G 8 1 1 Source The data are those reported by Robinson and Flemming Brit J Obst Gyn V82 1975 p 702 710 Same as SIGMA 20 see memo Ch Gahwiler Author Robinson Sound Velocity 1540 m s Values are scaled from a sound velocity of 1530 m s as in the publica tion to 1540 m s for the table Uncertainty two standard deviation 15 10 01 APPENDICES 7 71 AVA KONTRON MEDICAL G 8 2 CRL from Hohler 8 mm from Hohler EBD week EBD week f amp EBD week CRL cm G 8 2 1 Source Charles W Hohler MD University of Miami School of Medicine Adapted from Robinson amp Flemming BJ Obs amp Gyn 82 702 1975 7 72 SIGMA 110 SIGMA 330 15 10 01 8 3 CRL from Jeanty
151. Press upper left SET key to fix the second angle side The result is automatically dis played on the screen Angle is always displayed in degrees 10 12 01 OPERATING INSTRUCTIONS 3 71 AVA KONTRON MEDICAL 3 14 3 5 Volume The volume measurement is composed of three distance measurements height and width dis tance measurements on the first 2D pad and depth distance measurement on the second one or vice versa 3 6 2 F 6K8 3 6 3lvg a Ellipse Thyroid Undo 0 523 0 479 The coefficient used for the volume computation is also displayed in the measurement result Measurement results C Coefficient D1 Distance D2 Distance D3 Distance V Volume pad When the Volume key is pressed the following sub menu is displayed Ellipse 0 523 Undo A maximum of four volume measurements are available The labels displayed in the measure ment key give information about the kind of volume the measurement apply to the coefficient used in the computation The volumes are computed according to the fol lowing formula v Da D1 D2 D3 coefficient D1 Distance 1 in millimetres D2 Distance 2 in millimetres D3 Distance 3 in millimetres V Volume in cm The labels and coefficients are defined by the user in the Radiology Study Sheet see Chapter H HRadiology Studybl on page 7 85 If the relevant data are not defined in the Radiology Study She
152. RINT icon in the Biometry Study Menu 3 15 5 Starting a Study To start a study on a new patient the following operations are required 1 Editing a patient identification sheet 2 Editing a biometry study sheet 3 15 5 1 Editing a Patient Identification Sheet To edit a patient identification sheet 1 Press ID key The complete patient identification data sheet appears on the screen Note The New Patient icon deletes all data except those related to Laboratory identification This function is recommended to restart a study at the beginning or to start a study on a new patient 2 Type on alphanumeric keyboard to fill out the desired areas Please refer to Chapter 3 12 3 Manual Text Annotation on page 3 60 3 Press REPORT key to display the biometry study sheet which corresponds to current mode and medical application 10 12 01 OPERATING INSTRUCTIONS 3 91 H 4 TRON MEDICAL press ID key to return to a frozen image or press FREEZE key to return to a live image 3 15 5 2 Editing a Biometry Study Sheet To edit a biometry sheet 1 Acquiring the required ultrasound image 2 Press REPORT key The specific biometry study sheet appears on the screen 3 Click on the desired area corresponding to measurement to be performed The ultrasound image appears on the screen Perform the required measurement See Chapter 3 14 Measurements on page 3 67 After completing the measurement the screen
153. Ratio Velocity Systole Diastole Vels Veld S D1 Angio Doppler Auto Trace Resistance Index RI RI1 Angio Doppler Auto Trace Velocity at Systole Vels VpeakS2 Angio Doppler Auto Trace Velocity at Diastole Veld VED2 Angio Doppler Auto Trace Ratio Velocity Systole Diastole 15 10 01 Vels Veld S D2 APPENDICES Angio Doppler Auto Trace 7 103 H 4 KONTRON MEDICAL K 4 Obstetric and Gynaecology K 4 1 2D measures In the following table Sono Win defines Description SIGMA Sono Win Chapter Last Menstrual Period LMP Date LMP Date Patient data Estimated Birth Date EBD Date EDD Date Patient data weeks Number of Weeks of Amenorrhea NWA weeks DGA Patient data days CRL Crow Rump Length CRL see CRL_WEK see P Ob Fet 1 CRL_SD see see lt nor lt nor mal gt lt SAC Gestational GES super SAC_WEK uper Ob Fet 1 script SAC_SD script gt b gt lt TOF rmal gt mal gt see see lt nor lt nor mal gt lt CHD mal gt lt Chorion Diameter ChD super CHD_WEK super Ob Fet 1 script CHD_SD script gt a lt no gt b lt no rmal gt rmal gt see see lt nor lt nor mal gt lt BPD mal gt lt Biparietal Diameter BPD super BPD_WEK super Ob Fet 1 script BPD_SD script gt a lt no gt b lt no rmal gt rmal gt see see lt nor lt nor mal gt lt ORB mal gt lt Binocular Distanc
154. S Electronic linear scanning Electronic convex scanning e Annular array sector scanning e Doppler Pencil probes DISPLAY MODES e Real time 2D B Mode display modes Single 2D format e Double 2D format e Quad 2D format e 2D panoramic zoom for mechanical probes only e 2D scroll zoom for LINEAR CONVEX probes only e 2D magnification e TM M Mode display modes Quasi Duplex 2D TM 2D 50 screen TM 50 screen e Full screen TM CW display modes Quasi Duplex 2D CW 2D 50 screen CW 50 screen 2Di icon CW PW display modes 1 44 SIGMA 110 SIGMA 330 15 10 01 Quasi Duplex 2D PW 2D 50 screen PW 50 screen 2Di icon PW MONITOR Black amp White monitor 10 diagonal 640 x 480 pixels resolution Direct management of brightness and contrast includes loudspeakers and control knob for volume KEYBOARD e Six languages English French German Italian Spanish and Russian Cyrillic Backlightening of all keys and knobs Ten software controlled function keys for menu selection e Full alphanumeric capabilities B W video printer remote control Trackball for focus point setting TM CW PW line steering annotations positioning measurements cine mode review and arrow pointing Layout removable for cleaning operation Trackball removable for cleaning operation INFRARED REMOTE CONTROL option Ensure system control in any inadequate examination condition
155. SN SAS SSNS ASSN SS 10 12 01 3 7 2 2 TM Live Menu This menu is displayed when TM mode is selected 2 camme This function allows the user to select different time bases approximately from 1 to 4 sec onds in 2D TM and 2 to 8 sec in full screen TM Turning the softpot clockwise increases scrolling speed and consequently decreases time base Freq T Freq Jj This function allows the user to choose Freq T for a standard patient or Freq 4 for a less echogenic patient a TM Inv This function reverses the up down orientation of the 2D image displayed on the screen a Gamma 8 compression GAMMA curves are selectable by using the MP potentiometer a Enhance increasing contour enhancement to improve the image sharpening 7 positions are available between 3 and 3 Reject This function controls the dynamic range of the echoes that are displayed on the screen a Rainbow SIGMA 330 only This function controls the colorisation of ultrasound image The MP softpot allows the selection of 8 sets of colour Rainbow 0 to Rainbow 7 The one selected is shown in the Technical Data Window Rainbow 0 corresponds to black and white image display Rainbow 1 to 7 corresponds to colorised image a TIMI Display Hide Thermal or Mechanical Indexes 3 7 2 3 TM frozen Menu See 2D frozen menu in Chapter 3 7 1 3 2D Frozen Menu on page 3 30 3 7 24 TM Gain
156. Sector Probes Cardiology Abdominal 2D TM PW CW Ob Gyn Abdominal Ob Gyn 2D TM PW CW Cardiology Pediatrics Vascular Small parts 2D TM PW CW Neonatology Perivascular Small Parts 2D TM PW Breast Muskuloskeletal 6 5 MHz MR 6 5 3 5 MHz GP 5 0 MHz GP 7 5 MHz GP 14 MHz PV Pencil Probes PEN 2 MHz Cardiovascular PEN 4 MHz Vascular PEN 8 MHz Vascular TCD 2 MHZ Transcranial Doppler Table i Probe applications Details on the various applications are below xvi SIGMA 110 SIGMA 330 15 10 01 Abdominal Gynaecology Urology Application The probe applies ultrasound energy through the patient abdomen to obtain an image of the abdominal organs to detect abnormalities imaging and assess the blood velocity flow and pat ency of abdominal vessels through the Doppler modalities Perivascular Application The probe applies ultrasound energy through the neck or extremities of a patient to obtain an image of the carotid artery or other peripheral vessels that can be used to detect abnormalities or obstructions in the vessel In Doppler modes the probe applies ultrasound energy through the neck or extremities of a patient to assess the blood velocity flow or lack of flow and patency of peripheral vessels Small Parts Application The probe applies ultrasound energy through the skin to obtain an image or a Doppler flow visu alization of small organs such as the thyroid
157. Systems intended for scanning in multi application They both support 2D TM and spectral Doppler ultrasound modes SIGMA 330 additionally supports Colour Flow Mapping CFM SIGMA 110 330 can be used in following applications Abdominal Breast Cardiology Emergency Endocrinology Gastro enterology Gynaecology Musculoskeletal Neonatology Obstetrics Paediatrics Small parts Urology Vascular SIGMA 330 features some unique characteristics in its category 15 10 01 Dual Optimization Technique D O T Auto adaptive Frequency Adjustment A F A Advanced Tissue Echo Cancellation A T E C EasyPrint Option USB Link Option PW CW spectral Doppler Option CFM Option Multi frequency and Multi technology Transducers M M T Up to 5 transducers simultaneously connected Super High Frequency Transducer 5 Iris colour system for optimal rendering of echo structures 256 levels grey scale Up to 282 images cine loop KIPRISM digital storage Ergonomic design for optimal user comfort Remote Control INSTRUMENT DESCRIPTION 1 3 SIGMA 110 Family features some unique characteristics its category Dual Optimization Technique D O T Auto Adaptive Frequency Adjustment A F A Advanced Tissue Echo Cancellation A T E C EasyPrint Option USB Link Option Multi frequency and Multi technology Transducers M M T Up to 5 transducers simultaneously connected Super High Frequenc
158. The key corresponding to the current probe used is displayed pressed If a probe is not recognized by the system bad ID Invalid Probe is displayed instead of the probe name and the key is disabled If a probe is recognized by the system but can t be used e g Pencil probe with no doppler board the probe name is displayed but the key is disabled 10 12 01 OPERATING INSTRUCTIONS 3 11 AVA KONTRON MEDICAL 3 5 2 1 Probe Main Menu with One Linear Probe P 2 P 3 P 4 P 1 AS 1 AS 2 PEN Linear 1 3 5 2 2 Probe Main Menu with Two Linear Probes SIGMA with Switch Box P 2 P 3 P 4 P 5 P 6 AS 1 AS 2 PEN Linear 1 Linear 2 The recommended probes according to Medical Applications are listed in the table i on page xvi The main features of the probes are shown in the table ii on page xviii 3 12 SIGMA 110 SIGMA 330 10 12 01 3 6 Setup This function allows the user to select factory or user setup parameters Factory Setups are pre set by the Manufacturer and cannot be modified by user User Setups are created by users and can be modified renamed and deleted Each Setup is assigned to one probe and stores all the user accessible parameters for all the scanning modes 2D TM 2D TM depending on the dedicated application 3 6 1 Setup Menu Load Save Delete PCMCIA page 1 Prefs SETUP SETUP SETUP Card gt System page 2 Info Press SETUP on the user interface to display the setup menu 3 6 2 Loading a Setup
159. To help the service team to find the cause of this problem the user must press on the lt H gt key when dialogue is displayed and printout the current displayed screen This screen contains information concerning the last sent messages 5 5 13 Error 12 Cannot program TMPAVG The TMPAVG temporal average is programmed at system start up If an error is detected bro ken flash PROM contact problems on it etc this error message can be displayed e when a new software is downloaded when the system is re configured with a new configuration key If this message is displayed the user must inform the service team its system may have a hard ware problem 5 20 SIGMA 110 SIGMA 330 15 10 01 5 5 14 Error 13 CFM Frame Filter LUT Error At start up the frame filter LUT content is checked and updated if needed This error is displayed when the LUT can not be reprogrammed this is usually due to a hardware problem If this message is displayed the user must inform the service team 5 5 15 Error 14 CFM Function LUT Error At start up the function LUT content is checked and updated if needed This error is displayed when the LUT can not be reprogrammed this is usually due to a hardware problem If this message is displayed the user must inform the service team 5 5 16 Error 15 LUT programming lime out error This error is displayed when one of the LUT located on COL DOP board can not be repro grammed usually due to a
160. Transfer of patient information data and images between the SIGMA 110 330 and the PACS Transfer of images in digital format no loss of quality contrary to a frame grabber Powerful database for fast patient sorting regardless the number of patients and images Intuitive user interface and research criteria Export and import of most commonly used image formats bmp pcx jpg etc Fast access to images by a double click on images Selectable backup frequency Very reliable backup impervious to dust magnets moisture and shock thanks to the Magneto Optical Disk drive and disk delivered with the software D CO O CO DO DO D ja Rr Pure Bend vate atti xi twee p um oat E Bia UD BS Semone rice a mai ox 1 Picture Archiving and Communication System 10 12 01 OPERATING INSTRUCTIONS 3 103 4 HA MEDICAL 3 19 1 2 SonoWin Basic In addition to Sono Win Lite featu res Sono Win Basic PACS software offers a Transfer of calibration data and measurement between the SIGMA 110 330 and the PACS a Flexible configurable report templates for reduced working time a Simple drag and drop to include images into a report 3 19 1 3 Advanced features Additionally following options are available a Post Measurement Module for doing measurements on archived images a DICON int
161. Warning 22 Not enough place on SRAM Cannot store the image ox 5 4 4 14 Warning 23 Undefined Patient Name This warning can be displayed only when the KIPRISM option is on It is displayed the first time an image is saved with an undefined patient name Warning 23 Patient Name is not defined 5 4 4 15 Warning 24 Transmit Voltage is not under control This warning is displayed the first time the probe high voltage check fails see Chapter 5 3 3 Transmit Voltage Indicator on page 5 8 Warning 24 Transmit voltage is not under control A 5 16 SIGMA 110 SIGMA 330 15 10 01 5 4 4 16 Warning 25 No PC connected to USB port When the user intends to enter the PC mode and when no PC has been detected on the USB port the following warning message is displayed Warning 25 No PC connected on USB port 15 10 01 TROUBLESHOOTING 5 17 5 5 General Failures and Errors A system general failure can be caused by hardware software or transducer failure All the errors described below are the most important errors which could happen during the system use For some of them a restart of the system is involved Remark the user should press on any key to acknowledge the message 5 5 1 Error 0 Internal unexpected interrupt Internal and unexpected CPU errors are displayed with a generic Fatal Error dialogue box This error is displayed when an unexpected interrupt raise or when an internal protect
162. When this arrow is over a valid object the selected field is displayed in inverted video To enter the selection the user presses on the lt gt or lt SET gt key When the selected field is a main field the sigma switches to the frozen ultrasound 15 10 01 APPENDICES 7 3 AVA KONTRON MEDICAL image and the measurement associated with the selection is automatically started The user has now the possibility to e finish the measurement the sigma switches then to the report screen and automatically updates the selected field and if needed updates results fields and computed fields abort the measurement and return to the report screen the user aborts the measure ment by pressing on the lt ESCAPE gt key e abort the measurement and exit the biometry the user presses on the lt FREEZE gt key The sigma returns then to the live mode A 4 Importing Measurements in Report After having done a measurement the user wants to insert it in the report he selects the suitable report sheet and moves the trackball cursor on the fields of interest When a relevant field is pointed it highlights to indicate the insertion is possible The user then presses on the CURSOR SET key to insert the last measurement All the related results and computed fields are automat ically updated if all data are available Note to activate the import mode the measurement menu must be displayed before entering the report 7 4 SIGMA 110 SIGM
163. X Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 9 2 1997 2 30 PM 29 object s 3 18 4 Read data from a computer 3 30 MB My Com Once the flashcard has been recognized as a removable hard disk any PCX or TXT file can be read from the computer a from the file explorer double click on a file to open it a from a standard image viewer Imaging or a text editor Notepad open a file with the File gt menu 3 18 5 Copy data to the computer To copy images and text files from the flashcard to the computer just drag and drop the files to copy from the file Explorer to the destination directory 10 12 01 OPERATING INSTRUCTIONS 3 101 AVA KONTRON MEDICAL 3 18 6 Interface with PACS PACS can be interfaced with SIGMA 110 or SIGMA 330 when using USB
164. a second time the PW key to display a 2D icon PW format SIGMA 110 SIGMA 330 10 12 01 3 7 3 1 PW Mode Selection 9995555 ZALILA 772 227 272227722227 222222222222 222222222222 222222222222 22222722222 22222222222 27 112 244 PW 222 2 22222722222 4 7 r 7 a 722422277 uet ttt ERRERA 2277 2 4424444 PW 2272744 NNNNNNNNSNS NSNNNSNSASNS 9555555555 95595555555 955555555 69555555555 55555555 55555555 955555556 955555555 99555556 NNNNSNNNNSNS 955555555 2722422 Figure 3 5 PW Mode Selection 10 12 01 OPERATING INSTRUCTIONS 3 35 AVA KONTRON MEDICAL 3 7 3 2 PW Live Menu If PW is active the following SP menu is displayed on the screen 2D PW display sweep poesia PRFx2 page 1 gt Inv Freq lo Angle gt wanrit page 2 This function allows the user to select different sweep speeds approximately from 1 to 4 seconds in 2D SP and 2 to 8 sec in full screen SP Turning MP potentiometer clockwise increases scrolling speed and consequently decreases time base a Gatesize This function adjusts gate size The user can select a sample volume size of 1 2 4 6 8 10 12 and 15 mm Baseline The soft pot shifts the spectrum baseline 9 positions are selectable 100 75 50 25 0 25 50 7
165. able to Monitor 7 Ethernet Network cable if necessary FireWire IEEE 1394 cable to FireWire magneto optical disk drive 9 Reference 488364 AC power cable to FireWire magneto optical disk drive Figure 2 3 Integrated PC rear panel 10 12 01 Figure 2 4 Integrated PC front view mounted in the cart INSTALLATION 2 9 AVA KONTRON MEDICAL 2 7 Power Source Connection 2 7 1 Input Power Source The SIGMA 110 and SIGMA 330 instruments are designed to operate on single phase line sup ply The unit is automatically grounded via the power cable provided a 3 pin wall socket with a grounded third pin is used 2 7 1 1 MAINS VOLTAGE SIGMA 110 Light Master and SIGMA 330 Master Type 100 127 V 5 x 20 mm 200 240 V 5x 20mm Table 2 3 Line voltage Fuses rating for SIGMA 110 Light Master and SIGMA 330 Master RATED INPUT POWER RATED FREQUENCY 340 VA 100 127 V 50 amp 60 Hz 340 VA 200 240 V 50 amp 60 Hz Table 2 4 Power Frequency rating for SIGMA 110 Light Master and SIGMA 330 Master Check that the selected voltage range corresponds to local power line voltage See figure 1 12 SIGMA 110 Light Master and SIGMA 330 Master rear panel on page 1 26 to locate fuses 2 7 1 2 SIGMA 330 Expert and SIGMA 330 Excellence FUSES MAINS VOLTAGE Rating Top Type Bottom 100 127 V T4A T8A 5 x 20 mm
166. ailable on the Report when the medical applications Vasc Cardio or Radio are chosen STORE key does not save the current medical application but save all valid measurement in all medical applications 10 12 01 OPERATING INSTRUCTIONS 3 55 3 11 4 3 Report Print Preview menu This menu is available on the Report in Print Preview mode e po Le Le 3 11 4 4 Patient and Study Information This menu is available when the user enters Patient ID LL leo be Li The STORE key will create a new patient file on the memory card if the user has pressed the new patient key else it will modify the last patient saved Each time the STORE key is pressed a dia logue box appears for a confirmation To avoid confusion a unique identifier is created internally for each patient 3 11 4 5 Reports As above mentioned Chap ter 3 11 2 1 Panels of 16 27 04 00 10 53 35 FILE SMITH TXT E CREATED 19 11 97 10 01 54 Images on page 3 52 the CREATED 1 mode entered when press PAGES 13 REPORTO3 TXT ing on the Archive key of PATIENT INFORMATION the Freeze menu is the Laboratory SAINTE ANNE Thumbnails mode and the Physician a perator MH corresponding menu is dis 42 played To select the Report PATIENT RE
167. amaged and open files will not be saved Shift keys Using shift key combination allows access to country specific codes Lower upper case Usually we use the shift key combination to select an upper case character Here on the SIGMA keyboard the user must press CAPS LOCK key to select upper case mode and then press it again to go back on lower case mode Print 2 key This key is affected in PC mode to send a print command to the active application 3 20 6 4 Stickers for Keyboard Keys as CTRL and ALT are frequently used in a PC user interface so they have to be found easily on the keyboard Their affectation is indicated on the keyboard by using stickers as shown below 9 Caps BODYMARK SETUP Cul Tab ANNOT PROBE Alt Ins REPORT MAGNIFY Alt Gr Del 10 12 01 OPERATING INSTRUCTIONS 3 113 3 20 7 Errors and warnings When the user intends to enter the PC mode and when no PC has been detected on the USB port a warning message is displayed For more information refer to Chapter 5 4 4 16 Warning 25 No PC connected to USB port on page 5 17 3 20 8 PC power on The integrated PC starts automatically when the system is powered on When the following win dow is shown the user has to Be CTRL ALT DEL and enter his user name and password in Windows 7 Buit on NT Tedhnatoce ET Pra Chi aom Dalsta to begin CHEAUE Dod laesi parer p
168. ar ceo 2 Press Def Lst Define List key Medica User1 User2 User3 User4 Clear crearan 4 Enter the list name ex Cardio 1 max 8 char then press ENTER Creating a new list Enter the list name The new list name appears in the list menu and a window is displayed on the top right of the screen 5 Enter the labels in the window using the keyboard 14 char max label then press ENTER 6 Press Def Lstto end the new list 10 12 01 OPERATING INSTRUCTIONS 3 61 AVA KONTRON MEDICAL 3 12 4 2 Delete a Label List 1 Press Del List User1 User2 gt List Medica User3 User4 Del List Clear ClearAll 2 Select the list to be deleted EELO 3 Confirm in the dialogue box Yes or No Deleting the list xxx Do you want to continue 3 12 4 8 Renaming a User Label List 1 To rename a user label list the user should press on the key Def list in the Anno tation menu New list User list f User list 1 2 2 To rename one of the list the user presses on the corresponding function key and enters the new name Renaming the list xxx Enter the new name On the label menu the current name is automatically updated Remark The number of user label list is limited to 4 for each medical application 3 12 4 4 Label List The size of the labels shoul
169. are not used for the PC keyboard and trackball but for the SIGMA as usual D DO O B cmm S ccm 1 2 3 4 5 6 7 8 9 0 as q w e r t y u i p 5 f g h j k x m m E E es e CTRL ALT P e Bae SE Alt GR 3 112 SIGMA 110 SIGMA 330 10 12 01 Menu keys The menu keys allow to access the keys which are not accessible directly from the SIGMA key board or are not intuitive enough They allow also to hide such application specific key combina tions They are presented on 2 menu pages Start End Show Hid End Back to Scan CFM win now SIGMA gt Je L Pe L Ls 2 Application specific menu key can help the user by allowing direct access to complex key sequences or specific controls These specific keys are a Start stop scan Used by 3D software a Show hide CFM window Hide or show CFM window and wall filter marker a End now Ends the shut down process without waiting for the PC shut down only valid in a shut down sequence WARNING use this key with care Hard disk of the PC can be d
170. asurement ciere eta ea lasci pee once as Ai dna reus 3 68 3 14 3 2D Mas iran Osan bna HER End 3 68 c MICE 3 75 3 14 5 TIMOMGASUFGITIGTIL oed ses ces ova bool a eile 3 77 3 14 6 Doppler MeasUFerfirit s rude toe taret x E cea ee eve ee 3 82 3 15 Biometry and it Pc pecie ae repr E banks 3 90 315 1 Biomelry PICIOGEalfiS aui rr Deere tide et EFT En Qu rir De Pai eim HE Eel 3 90 3 15 2 Patient Information ai 3 90 3 15 3 Biometry Patient 0 3 90 i AEs WAC OOF dein duda E 3 91 3 15 5 Starting a B Eu 3 91 215 6 ba sun man Meee a chon 3 92 3 15 7 Obstetrics Gynaecology Study esie t eae 3 93 221562 Vascular Study i cien ice 3 94 3 15 9 Cardiology yah 3 94 910 EGG ODUDIE 3 95 37 EasyPrint iiaae bere red 3 96 3 TZ OL Images 22 enea aia a a a aM eem d ces 3 96 3 17 2 Prin
171. ata On Off Technical Data can be displayed on the screen Use TecD F3 function key to display or not the Technical Data Annotation Erase annotation on Unfreeze preference is now Keep Annot Erase Annot The annotations displayed on the screen are kept or erased when the display is unfrozen Choose between keep or remove annotations with the Annot key F4 Press on the char acter corresponding to the first letter of the strings in the buttons 10 12 01 OPERATING INSTRUCTIONS 3 15 a Screen Saver 3 16 Screen saver s settings 2 10 minutes 3 20 minutes 4 30 minutes Cancel With this dialogue box the user can select the time until a screen saver will be started if the machine is not used By touching any key or the trackball the screen saver will be stopped The default value is off Refresh On Off Refresh function in Doppler and TM modes can be enabled or disabled Use Refr F6 function key to enable or not this function When it is on 2D image is refreshed at the end of each SP or TM sweep Time Time display 1 24 hour clock 2 12 hour clock The user select Time display 24 hours 12 hours Default setting is 24 hours for PAL ex 14 50 36 Default setting is 12 hours for NTSC ex 2 50 36 PM AFA Enables or
172. atient icon from the patient ID page The data relevant to the previous patient are automatically transferred a power off the SIGMA if KIPRISM data are stored on the SRAM the operator is prompted to transfer data As soon as Sono Win has successfully read all the information stored on the card the input data will be automatically deleted from the SRAM card by the ultrasound device If individual measure ments cannot be assigned automatically the procedure for the manual assignment is the same in this operating mode as in the mode described above Note that the following error message may be displayed by Sono Win after having started N snos re SR cond d pected Loa aphon Pad andy prion 10 12 01 OPERATING INSTRUCTIONS 3 107 This means that SonoWin can not work because it has not accesses to the PCMCIA card The setup on PCMCIA card accesses must be modified in the preferences menu Setup Prefs 2 System PCMCIA card and the option Full accessed must be selected Selecting this option is absolutely essential otherwise option Read only accessed is selected the data transfer between the ultrasound device and the PC via a USB cable connection is not possible 3 108 SIGMA 110 SIGMA 330 10 12 01 3 19 5 Data Assignment This chapter is only valid for the Basic version of Son
173. ating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is not reported for the reason listed 7 136 SIGMA 110 SIGMA 330 15 10 01
174. ation of the scan plane marker except in cardiology application then press Upper SET a m The angle of the marker can vary from 75 to 75 by step of 15 N o is 4 Press ESCape to exit the BODY MARKER Menu gt 10 12 01 OPERATING INSTRUCTIONS 3 65 3 13 2 Moving Body Markers In Dual Quad and Archive mode the Body Markers can be moved anywhere on the selected image To move the body markers A 1 Press the key 2 Select the desired image using the SELECT key ls 3 3 Move the marker using the Trackball 4 Then press Upper SET key Ea 19 3 13 3 Deleting Body markers 4 To delete the body markers Selecting Clear Body Mrk erases the last Body Marker Selecting ClearAll clears the screen of all Body Markers and all annotations Different body markers are available in the different medical applications see Chapter 3 13 4 Medical on page 3 66 and Appendix L Body Markers on page 7 111 3 13 4 Medical Selecting Medical in the ANNOTATION Menu displays the Medical Application menu The user can select one of the Medical Applications Ob Gyn Radio Vasc and Cardio The cor responding set of Body Markers will be available The Medical Application menu can be accessed from Study sheet by selecting Medical Application icon Note that the setting parameters of the operating probe are not affected by this change d Radio Vasc
175. ation on the actual power of the system The following sections describe the rationale of this methodology KONTRON MEDICAL recom mends the use of the ALARA principle see below which is extensively covered in this manual Additionally to this operator manual you get the AIUM manual Medical Ultrasound Safety which covers the following topics more in detail Bioeffects and biophysics prudent use and implement ing ALARA Read it carefully before using the SIGMA 110 330 Clinical Safety In the USA in more than three decades of use there has been no report of injury to patients or operators from medical ultrasound equipment American Institute for Ultrasound in Medicine AIUM Statement on Clinical Safety October 1982 Revised March 1993 and October 1993 Diagnostic ultrasound has been in use for over 25 years Given its known benefits and rec ognized efficacy for medical diagnosis including use during human pregnancy the Ameri can Institute of Ultrasound in Medicine herein addresses the clinical safety of such use No confirmed biological effects on patients or instrument operators caused by exposure at intensifies typical of present diagnostic ultrasound instruments have been reported Although the possibility exists that such biological effects may be identified in the future current data indicate that the benefits to patients deriving from the prudent use of diagnostic ultrasound outweigh the risks if any that may be present
176. automatically toggles to the biometry sheet The value of the measurement is stored in the current field 4 Repeat the operations in item 3 as many time as required 5 Select REPORT pictogram to edit the corresponding report or select NEXT PAGE picto gram to display the next page of the Biometry study The user can exit the current Biometry Study using the following keys REPORT to return to the frozen image FREEZE to return to the live image MAGNIFY to magnify the frozen image MEASURE to enter Measurement Menu frozen image ANNOTATE to enter Annotate Menu frozen image ESC to exit Biometry Study when first sheet is displayed see also Chapter 1 4 System Controls on page 1 28 D CO O DO DO DO Note During some transfers Please wait message appears on the screen to show that the system is changing display format 3 15 6 Radiology Study The abdominal and pediatrics study is included on the radiology study sheet See Radiology study sheet measurements and equations in Appendix H Radiology Study on page 7 85 1 Click TRACKBALL CURSOR SET move the cursor to the desired area when the cursor is over a selectable area the corresponding field is highlighted and press SET 3 92 SIGMA 110 SIGMA 330 10 12 01 3 15 7 Obstetrics Gynaecology Study From Ob Gyn Medical Application 3 15 7 1 EBD according to LMP 1 2 Press REPORT key to display Ob Gyn Study Sheet Highlight LMP area with track
177. ball and enter the date of Last Menstrual Period with alphanumeric keyboard as Day Month Year for PAL version Example 26 02 2001 26 February 2001 Month Day Year for NTSC version Example 02 26 2001 February 26th 2001 When LMP date information is entered the system calculates EBD Estimated Birth Date and NWA Number of Weeks of Amenorrhea 3 15 7 2 Fetus Age according to Physical Measurement 1 2 3 Acquire an ultrasound image in 2D mode Press REPORT key to display Ob Gyn Study Sheet Select in the Meas column the field corresponding to the parameter to be measured when it is highlighted Press SET key the system switches to the ultrasound image display Perform the required measurement the according value and estimated foetus age appear on screen when the measurement is confirmed the study sheet is displayed again The measured value is stored and displayed in the study sheet For each measurement the system determines the Age of the fetus and EBD using a table When all measurements are performed the system calculates some parameters and ratios such as AUA HC AC 3 15 7 3 Growth Curves The CURVE VIEW icon is used to display the different growth curves from OB GYN STUDY sheet place the cursor on the measurement of interest when the field is highlighted press F3 CURVE VIEW the corresponding curve is displayed a from OB GYN SETUP sheet place the cursor on the name of desired
178. ball assign ment but the actions associated do not change a The first key 4 selects the previous panel of items patients or the thumbnails This key is disabled for the titles or if only one panel exists for the thumbnails a The second key selects the next panel of items patients or thumbnails This key is disabled for the titles or if only one panel exists for the thumbnails 3 52 SIGMA 110 SIGMA 330 10 12 01 KONTRON ERZ HAN MEDICAL The third key is used to delete the current selected item patients titles or thumbnails When the user presses it a dialogue box appears for a confirmation not for the title The fourth key is used to delete all items of the selection patients titles or thumbnails When the user presses it a dialogue box appears for a confirmation The fifth key is used to undo the deletion of items It restores all deleted items it is not an undo action This key is not available for the titles This key is disabled if no items have been deleted This menu is available when the selection is assigned to the thumbnails Delete Del All Undo A v Image Images This menu is available when the selection is assigned to the Titles Delete Del All Undo A v Title Titles 3 11 2 3 Principles of Selection and Validation The three SET keys change the assignment of the trackball The trackball be assigned to the image list or to the title to change the position of the c
179. body marker set according to the current medical appli cation 1 4 32 ANNOTATE The ANNOTATE key displays or hides the annotation menu on the screen and automatically freezes image Annotation menu enables annotation writing displays cursors or body markers on the screen 1 30 SIGMA 110 SIGMA 330 15 10 01 1 4 3 3 MEASURE The MEASURE key displays or hides the measurement menu on the screen and automatically freezes ultrasound image 1 4 34 REPORT The REPORT key enters or exits the report screen and automatically freezes image When exit ing report the system returns to frozen ultrasound image display 1 4 4 Trackball The trackball and the 3 trackball buttons are linked together These buttons have different func tions Upper left key Upper right key Lower key The actions associated to those keys are Upper left key is used to select the next available action in the action list a Upper right key is used to select the previous available action in the action list Lower key is used to select the position cursor Action lists are managed in a circular manner if the upper right upper left key is pressed and if the current selected action is the last one the first one then the next selected action will be the first last action of the actions list This convention is used for each mode except for Measurement Biometry e Annotation Pop up menus KIPRISM see Chapter 3 11 2 3 Pri
180. by pressing on the BACKSPACE lt key 10 5 0 8 0 6 0 4 0 2 Z 0 0 2 78510 0 4 0 6 0 8 Lp ms Freq VTI Hearne RI Ratio undo The result of the frequency measurement depends on the current SP scale and is displayed in kHertz on the right side of the screen Do 3 14 6 3 Velocity Time Integral and Mean Velocity Integral Measurement By adding VMean VMax automatic detection feature the integral measurement has been modi fied to be made automatically or manually on the two different integrals types a VMax integral a VMean integral On the ultrasound page these two integral measurement results are always called for Integral but on the biometry pages these two results are called differently to be easily distinguished If VTI or MVI measurement is selected by the user a sub menu is displayed to erase the last dis played points equivalent to the Backspace key or to be able to switch from automatic to manual integral computation for VTI only MVI is always automatic 3 84 SIGMA 110 SIGMA 330 10 12 01 Automatic VMax VMean measurement Biometry results for VMax Biometry results for VMean PkV XX XX cm s PkV XX XX cm s TAM XX XX cm s TAV XX XX cm s PkG XX XX mmHg PkG XX XX mmHg MnG XX XX mmHg MnG XX XX mmHg 1 When the first integral point is set the integral
181. ce it on the area which has to be studied Set the TM line to the desired position When releasing the trackball the 2D image is automatically frozen and the Time Motion becomes active If the TM line is repositioned using the trackball the 2D image will get unfrozen again The 2D image can be refreshed at the end of each TM sweep The Refresh option can be enabled or disabled in the Preferences Menu SET UP gt Prefs gt Display gt Refr ON OFF If the user want to get the 2D image active without changing again to TM press the SELECT key To restart the automatic changing between 2D and TM press the SELECT key again Press a second time the TM key to display a TM single format OPERATING INSTRUCTIONS 3 31 AVA HAN 3 7 2 1 3 32 KONTRON ME DICAL TM Mode Selection Carers 2 424 447 727 74 7 27 77 7 7 7 ae 2 7 7 2 7 7 72 7 oe E 24 2 AP PPP 7774 7 PL P 22 7 7 Loree 2 227 27 77 227 772 224444444 77727 PE PP rarer 444 7 2 74 7 N x s N 9955955555556 N SN NS NN REN N M 9556555555 9995555555 NN NS NAN SSN NSS SSNS NN 7 7 2 AANA Figure 3 4 TM Mode Selection SIGMA 110 SIGMA 330 NNNNNNANANANANANNANANNA RANA NSS
182. changing of the wall filter cut off frequency which can be manipu lated with the MP The selectable cut offs depend on the actual velocity range Col Invert Pressing this button toggles between inverted and non inverted colour map Persist Pressing this button activates the changing of the persistence of the colour pixels on screen Three different persistence modes are available with the MP 0 no persistence 1 and 2 Energy Pressing this button activates the increasing decreasing of the transmit energy The energy can be adjusted between 21dB and 0 dB in steps of 3dB with the MP 0 dB corresponds to maximum energy which is smaller or equal to the recommended level for the selected application see Chapter 1 7 12 Acoustic Power on page 1 51 TIMI Display Hide Thermal or Mechanical Index 3 7 5 4 Frozen Menu When pressing the FREEZE button in CFM live mode the following menu is displayed on screen le Map thresh I Store lo Off achive 3 44 Pressing this key activates the setting of the threshold level between CFM and 2D informa tion in order to select whether the CFM or the 2D information is displayed For low thresh SIGMA 110 SIGMA 330 10 12 01 4 KONTRO MEDICAL old the 2D information gets higher priority over the CFM information The Threshold level can be set by the MP See CFM live menu in Chapter From the previous menu Sub Applicati
183. ching ON SIGMA 110 and SIGMA 330 Master The power ON OFF sequence consists of 3 states Instrument OFF STAND BY ON To switch the instrument ON 1 Push the ON OFF power switch on the rear panel of SIGMA 110 see figure 1 12 SIGMA 110 Light Master and SIGMA 330 Master rear panel on page 1 26 The green power indicator lamp located in front of the control panel will blink This light shows that the system is in wait state 2 When the power indicator lamp blinks press the ON OFF key on the keyboard or on the remote control A beep sounds when the program enters the start up procedure The green power indicator lamp located in front of the control panel illuminates The initialization sequence starts see Chapter 3 2 4 Initialization of SIGMA on page 3 5 3 2 2 Switching ON SIGMA 330 Expert The power ON OFF sequence consists of 3 states Instrument OFF STAND BY ON To switch the instrument ON 1 Push both ON OFF power switches on the rear panel at the bottom and behind the mon itor of SIGMA 330 see figure 1 10 SIGMA 330 Expert rear panel on page 1 23 The green power indicator lamp located in front of the control panel will blink This light shows that the system is in wait state 2 When the power indicator lamp blinks press the ON OFF key on the keyboard or on the remote control A beep sounds when the program enters the start up procedure The green power indicator lamp located in front of the c
184. city in metres per millisecond S Slope in metres per square seconds Cardiac Output in litres per minute CO coD SV HR 1000 SV Stroke Volume in millilitres HR Heart Rate in beats per minute Cardiac Output Index in litres per minute CO ci D BSA CO Cardiac Output in litres per minute BSA Body Surface Area in square meters Stroke Volume in millimetres SV SVD area p VTI 2 m D p D 7 VTI Velocity Time Integral D Diameter of vessel in centimetres Stroke Index Volume in millilitres per square metres 51 SV 1 2 5 SV Stroke Volume in millilitres BSA Body Surface Area in square meters 7 28 SIGMA 110 SIGMA 330 15 10 01 H 4 KONTRON HAN MEDICAL D 4 3 2 Tricuspid Valve Right Ventricular Right Auricular Gradient in mmHg RVRAGr RVRAGR D4 TRV TRV Tricuspid Regurgitation Velocity in meters per second D 4 3 3 Continuity Equation e Area in cm2 computed from 2D diameter 1 Di 2 pias Diam Diameter in cm Area cm2 computed from velocities AREA2 AREA2 DAREAI Vell Vel2 Vel1 Velocity 1 in m s Vel2 Velocity 2 in m s Area in cm2 computed from velocities time integral AREA2 VTI2 VTI1 Velocity Time Integral 1 in cm VTI2 Velocity Time Integral 2 in cm 15 10 01 APPENDICES 7 29 7 30 This page is intentionally left blank SIGMA 110 SIGMA 330 15 10 01 Appendix Vascular Study E 1
185. cle Diameter systole in cm PWs Posterior Left Ventricular Wall systole in cm IS Inter Ventricular Septal Thickness ratio LD Left Ventricle Diameter ratio PW Posterior Left Ventricular Wall ratio EFr Ejection Fraction 3 80 SIGMA 110 SIGMA 330 10 12 01 Ab LVSt Abbreviate Left Ventricle Study a SK Distance Time Slope Heart Rate Ab LVSt Fu LVSt Ratio Undo Gm 7 lt 1 6skm gv sly 6sKl 83 lv 6SK 639 GM 8832 3 14 5 6 TM Ratio or Delta Ratio The TM ratio or delta ratio calculation is available for the TM Distance measurement delta ratio TM Time measurement ratio Delta ratio on TM distance measurement Distance Rate Delta Undo Technical Data 6K 1555 TK 655 5 555 For the delta ratio on a TM distance measurement the result of the distance measurement and of the distance delta ratio measurement is displayed 10 12 01 OPERATING INSTRUCTIONS AVA KONTRON MEDICAL Ratio TM lime measurement Technical Data Gt 6551 TJ 37 lt 1 TY 7 lt 55 Distance Slope Heart Rate E os ratio Undo For the ratio on a TM time measurement the result of the time measurement in seconds and of the time ratio measurement in percent is displayed 3 14 6 Doppler Measurement If y
186. cle Study heh et saa etie eei ccd 7 26 Appendix E Vascular nn neneee 7 31 ET IBesODDHDI erac de eine oa n oooh Vin Wars de tn mana ccs 7 31 E 2 Stenosis Percelllage oe tel cas tenes a Rouen up cages usse quu pn DER MR MEE 7 31 Beso zie ITE 7 33 Appendix Ob Gyn 7 37 EXE BE OU 7 37 R2 TMSESITSSL Gov nq a S UR 7 41 F 3 Foetal Information Shieet ocu cic t 7 43 E Setup Sheet 7 44 User Table Slleek eni A pb SE acai 7 47 0 RUIT n cR 7 48 Appendix G Reference Tables for 7 49 Gl Biparetal Diameter acted toca itl acte ardua Rt 7 49 G 2 Chorion Diameter ChD from Rempen 7 57 8 22 Femur EMO ossium Noa viae ei nbn dis 7 58 G4 Humerus Length Hb eiie nene nota pne dt seus 7 65 G 5 Transabdominal Diameter TAD from Merz 7 67 G 6 Thoracic Diameter THD from Hansmann 7 68 G 7 Anterior Posterior Diameter
187. cle Study D 1 1 This sheet owns three parts as described here under Description 14 01 98 08 30 31 D 1 1 1 Left le ii Ventricle Study a 2D measurements LALd Long Axis Length at diastole in cm LAAd Long Axis Area at diastole in cm2 LALs Long Axis Length at systole in cm LAAs Long Axis Area at systole in cm2 gt VOLd Diastolic Volume in cm3 gt VOLs Systolic Volume cm3 gt EF Ejection Fraction in percent gt SV Stroke Volume in millilitres gt 5 Stroke Index millilitres gt CO Cardiac Output in litres per minute gt Cardiac Index in litres per minute per square meters b TM measurements RVDd Right Ventricle Diameter at diastole in cm IVSd Inter Ventricular Septal Thickness at diastole in cm 7 12 SIGMA 110 SIGMA 330 LAB 1 OPER gt EXAM Nieeeee W kg AGE y BSA m2 HR b mn __ CARDIOLOGY STUDIES LEFT VENTRICLE LEFT VENTRICLE TM
188. d 5 wall filter off 0 application ObGyn velocity range kHz 250 steering angle degrees 0 Notes a This index is not required for this operating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is not reported for the reason listed 7 124 SIGMA 110 SIGMA 330 15 10 01 not reported for the reason listed 15 10 01 APPENDICES MEDICAL Transducer Model 3 5 MC Operating Mode B mode TIS TIB TIC Index Label MI MEM Il saa eee Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value 1 8 a 2 7 g Wo mW min of W 3 z4 3 21 1 mW 21 cm A bp cm 2 Zp 3 46 deq Zsp cm gt fc MHz 2 40 Dim of Aaprt x cm z m 2 PD msec 0 84 6 PRF Hz 1000 Pr Pllmax MPa 3 5 deq Pllmax cm 5 Focal Length FLy cm 9 Fly cm IPA 3 M max W cm 354 2 depth cm 24 5 frequency f f f 5 angle 75 focus cm 3 Notes a
189. d Volume Ellipsoid volume in cm3 V V D4 3 a 21 02 03 D1 Distance 1 D2 Distance 2 D3 Distance 3 E 3 5 Spectral Broadening Index Time Average Velocity in metres per second TAV TAVD MVI Mean Velocity Time Integral Time Duration flow in seconds Time Average Maximum Velocity in metres per second TAMX TAMX D WL Time VTI Velocity Time Integral Time Flow duration flow in seconds e Spectral broadening Index SBI SBI p D 100 Time Average Velocity m s TAMX Time Average Maximum Velocity in m s E 3 6 Cardiac Output Stroke Volume in millilitres SV SV Darea p VTI 2 area Velocity time integral D Diameter of vessel in centimetres Stroke Index Volume in millilitres per square metres 51 SV 1 gt gt h BSA SV Stroke Volume in millilitres BSA Body Surface Area in square meters 7 34 SIGMA 110 SIGMA 330 15 10 01 Cardiac Output in litres per minute coD SV HR 1000 SV Stroke Volume in millilitres HR Heart Rate in beats per minute Cardiac Index in litres per minute per square metres CO 10 gt BSA CO Cardiac Output in litres per minute BSA Body Surface Area in square meters E 3 7 Volume Flow Time Average Velocity Time Average Velocity cm s MVI Mean Velocity Integral in cm corrected according to the angle Time
190. d be less than or equal to 14 characters At the same time only 6 labels can be displayed in the list box If the label list is greater than 6 labels only the first 6 ones are displayed Arrows scrolling Up Down Arrow are displayed on the top and on the bottom to scroll the list page scrolling 3 62 SIGMA 110 SIGMA 330 10 12 01 Q Adding and deleting user labels To add user labels in the current label list the user selects the empty field at the end of the list by pressing on the upper left trackball key or any alphanumeric key enters its new label and validates this label by pressing on the ENTER key To delete a label select it and press on the lt BACKSPACE gt key the complete label will be removed Q Moving the label list Up Down By moving the trackball the user puts the focus rectangle on the scrolling Up or Down arrow When the focus rectangle is on the scrolling Up Down Arrow the list scrolls up down automatically by step of one page until the beginning end of the list is reached 0 4 scrolling Up Arrow Left Right Lobe alani lt Focus rectangle ongitudina D scrolling Down Arrow 3 12 4 5 Changing Current Displayed List By using the function keys F1 F2 F6 F7 another label list is selected On the right part of the screen the current displayed label list is replaced by the new one 3 12 4 6 Displaying a Label on the Ultrasound Image The user selects a label by
191. d on In edition mode the user can select predefined variables from the popup menu The Enter key or the up left trackball key validates then the definition of the field Note that the character is used as a leading character for predefined variables name These steps must be fulfilled for each field to print in the footer or in the header When all the relevant fields are defined the user saves its work by leaving the Printer Setup menu These fields are then stored in NOVRAM and retrieved each time the system is started If the user presses the Default key the default values are restored Default values are defined in the figure above Copyright and System values The System parameter describes the KONTRON MEDICAL mark the system type SIGMA 110 SIGMA 330 and is defined in the following way the text is SIGMA 330 KONTRON MEDICAL for a SIGMA 330 system SIGMA 110 KONTRON MEDICAL for a SIGMA 110 system the text must be discreet and so it will be displayed using a special font style italic Note The user cannot delete the system variable Variables deletion The user can delete a variable by pressing the SPACE key or the lt BACKSPACE gt key 2 30 SIGMA 110 SIGMA 330 10 12 01 When Gamma is pressed F3 key the following screen is displayed 14 09 00 08 30 31 Gamma Contrast sy pO 25 5 Brightness 0 75 5 05 Header General amp Foot
192. de Manual mode is only available with Vmax 1 1 2 6 Measurement Computing the Pulsatility Index updates also the Resistance Index But the Resistance Index can be computed separately L1 2 7 Area Measurements An area can be computed either with an ellipse or an area measurement according to user s preferences User preferences are defined in the preference menu 2 Importing Measurements in Report The user can do a measurement from the measurement menu and can insert the last measure ment in the report sheet 15 10 01 APPENDICES 7 91 AVA KONTRON MEDICAL 1 2 1 Operating Mode After having done a measurement from the measurement menu the user can insert it in the report The user selects the suitable report sheet and moves the trackball cursor on the main fields of interest When a relevant field is pointed it highlights to indicate the insertion is possi ble The user then presses on the CURSOR SET key to insert the last measurement All the related results and computed fields are automatically updated if all data are available Note to activate the import mode the measurement menu must be displayed before entering the report 1 22 2 Special Cases 1 2 2 1 Ratio Measurement All ratios measurement can be inserted in the corresponding fields e g a distance ratio can be inserted in a distance field a speed ratio can be inserted in a speed field 1222 RI Measurement
193. disables the display of Automatic Frequency Adjustment marker in 2D ECG On Off ECG function can be enabled or disabled When it is on ECG trace is displayed on the screen Press ECG function key F7 to toggle Rent On Off Time Renting option Enable or disable display of time renting informations SIGMA 110 SIGMA 330 10 12 01 3 6 5 3 Measurement Biometry Preferences Circumf Line VTI LV Cardio page 1 draw meas study setup page 2 gt a Circumference Circumference drawing preference is now Ellipse Ellipse Area In Obstetrics the circumference measurements Abdominal circumference and Head cir cumference are made from either Ellipse or Area drawing User can select either Ellipse or Area SETUP Preferences menu using Circumf 1 Preference for Ellipse circumference is computed from ellipse circumference Preference for Area circumference is computed from area contour Press the character corresponding to the first letter of the strings in the buttons to select your option a Line draw dashed line no line Line drawing on distance measurement preference is now Dash line gt line No line Distance measurement can be initialized with two different types of drawing User can select either Dash line or No line in SETUP Preferences menu using Line draw F2 Preference for Dash line a dashed line is drawn between
194. e Index values below 0 4 are displayed by this system as 0 4 Indices are displayed in 0 2 increments To optimize ALARA index values equal or higher than 0 4 are displayed even if the maxi mal index value does not exceed 1 0 The SIGMA 110 330 does not provide combination modes i e modes used simultaneously such as real time 2D and Doppler but can display a tracing Doppler or TM Mode with a reference 2D frozen or periodically updated The index for the active mode is indicated The SIGMA 110 330 Output Default Settings System default settings depend upon the probe the mode of operation and the application which is selected after selecting a probe The SIGMA 110 330 defaults the transmit power to obtain out put levels that are below the historic Ispta limits established by the FDA for the selected applica tion Methodology and Accuracy of Display The displayed indices values must be interpreted as relative information to help the user to achieve the ALARA principle Initial data are derived from laboratory measurements based on the AIUM standard Then the indices are calculated beginning from these measurements according to the AIUM NEMA Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diag nostic Ultrasound Equipment publication Many of the assumptions used for measurements and calculation are conservative in nature The measured water tank values are derated using the conservative att
195. e The trackball is used to select the area to be enlarged by moving a window on the image the magnified zone is displayed beside the entire image The softpot allows the image to be magnified by 1 14 to 2 73 The magnifying factor depends on image depth it is displayed in the technical data area on the right side of the screen Press Single or turn the softpot counter clockwise to exit Zoom Scrolling Zoom for Linear Convex probes Press Zoom to magnify an area of ultrasound image The trackball is used to move the enlarged area on the initial image in the image depth direction only the magnified zone is displayed A Zoom Range Indicator is displayed on the left of the 2D Zoom Menu to locate the current enlarged area For instance the drawing below shows a full scale of 24 cm cor responding to the explanation depth of entire image and the displayed area x 1 85 approximately from 5 5 to 18 5 cm t zoom t Freq 4 2 Inv Right The magnifying factor depends on the image depth and the operating probe according to depth 1 to 3 magnifying factors are available The softpot is used to select the desired magnifying factor 1 15 to 3 The magnifying factor is displayed in the technical data area on the right side of the screen Press Zoom Out to exit SIGMA 110 SIGMA 330 10 12 01 a Freq Freq This function allows the user to choose Freq higher frequency for a standard patient or Freq lower frequency f
196. e available only for VTI the user can draw the integral himself 10 12 01 OPERATING INSTRUCTIONS 3 85 AVA KONTRON MEDICAL 3 14 6 4 Time See TM Measurement Chapter 3 14 5 2 Time on page 3 78 for details 3 14 6 5 Heart Rate See TM Measurement Chapter 3 14 5 4 Heart Rate on page 3 79 for details 3 14 6 6 Blood Flow This measurement is only available 2D SP 2Di SP CFM SP or CFMi SP modes v A Me Ellipse arate BloodF Ratio Undo gt Measurement results mm gt Diameter of the vessel cm s gt Time Average Velocity x xx l mm Blood Flow The blood flow is measured in two steps and a message displayed for each step just above the menu first doing a distance measurement on the 2D image The message Distance measurement is displayed then doing a MVI measurement the SP pad to get the The message lt SET gt select the first point of the MVI integral is displayed Once the first point is selected the MVI sub menu is displayed see Chapter 3 14 6 3 BVelocity Time Integral and Mean Velocity Integral Measurementblon page 3 84 The blood flow is computed by using the formula TAV 60 2 D BF 2 1000 BF Blood Flow in l min TAV Time Average Velocity cm s D Diameter of the vessel in cm 3 86 SIGMA 110 SIGMA 330 10 12 01 4 KONTRO MEDICAL Note that the calliper moves are automat
197. e BOD super ORB_WEK super Ob Fet 1 script ORB_SD script gt a lt no gt b lt no rmal gt rmal gt see see lt nor lt nor mal gt lt OFD mal gt lt Occipital Frontal Diameter OFD super OFD_WEK super Ob Fet 1 script OFD_SD script gt a lt no gt b lt no rmal gt rmal gt see see lt nor lt nor mal gt lt HC mal gt lt Head Circumference HC super HC_WEK super Ob Fet 1 script HC_SD script gt a lt no gt b lt no rmal gt rmal gt 7 104 SIGMA 110 SIGMA 330 15 10 01 Description SIGMA SonoWin Chapter see see lt nor lt nor mal gt lt ATD mal gt lt Transabdominal Diameter TAD super ATD_WEK super Ob Fet 1 script ATD_SD script gt a lt no gt b lt no rmal gt rmal gt see see lt nor lt nor mal gt lt ALD mal gt lt Anterior Posterior Diameter APD super ALD_WEK super Ob Fet 1 script ALS_SD script gt a lt no gt b lt no rmal gt rmal gt see see lt nor lt nor mal gt lt AC mal gt lt Abdominal Circumference AC super AC_WEK super Ob Fet 1 script AC_SD script gt a lt no gt b lt no rmal gt rmal gt see see lt nor lt nor mal gt lt THD mal gt lt Thoracic Diameter THD super THD_WEK super Ob Fet 1 script THD_SD script gt a lt no gt b lt no rmal gt rmal gt see see lt nor lt nor mal gt lt FL mal gt lt Femur Length FML super FL_WEK super Ob Fet 1 script FL_SD script gt a lt no g
198. e changed This makes it possible for the user to get the best image possible while following the ALARA principle and thus to maximize the benefits risks ratio The SIGMA 110 330 incorporates a real time acoustic output display according to the AIUM NEMA Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment publication adopted in 1992 by both institutions This Output Display Standard is intended to provide on screen display of these two indices which are related to ultrasound thermal and cavitation mechanisms to assist the user in making informed risk i e patient exposure benefit diagnostically useful information decisions Considering the type of 15 10 01 GENERAL INFORMATION xxiii 4 KONTRON MEDICAL exam patient conditions and the case study level of difficulty the system operator decides how much acoustic output to apply for obtaining diagnostically useful information for the patient the thermal and mechanical indices real time display is intended to provide information to the system operator throughout the examination so that exposure of the patient to ultrasound can be reason ably minimized while maximizing diagnostic information For systems with an Output Display the FDA currently regulates only the maximum output The SIGMA 110 330 has been designed to automatically default to the proper range of intensity lev els for a particular application Howev
199. e entered on the keyboard of the SIGMA to remote control the PC SHIF T SELECT Once in PC remote control mode trackball actions and most of the keyboard actions are sent to the PC like a standard mouse keyboard When the user switches to PC mode keyboard a spe cific menu is displayed on the SIGMA screen 3 20 4 PC remote control features description The trackball emulates a three buttons mouse Mouse middle key Mouse left key Mouse right key Mouse move Mouse double left key action double click 3 20 5 Leaving PC remote control mode PC remote control can be left at any time by pressing SHIFT SELECT F5 Or FREEZE 3 20 6 Keyboard in PC mode 3 20 6 1 Introduction This section defines the use of the SIGMA keys in PC mode In PC mode the SIGMA keyboard becomes a PC one but some keys are still affected to SIGMA functions 3 20 6 2 SIGMA keys The following keys remain assigned to the SIGMA Sliders B gain D gain DEPTH PRINT 1 FREEZE MENU and POWER OFF D oO CO DO DO DO 3 20 6 3 PC keys Four set of keys can be distinguished 10 12 01 OPERATING INSTRUCTIONS 3 111 standard keys as letters digits control keys as CTRL ALT menu keys allowing access to function keys and some special characters trackball keys and events The following scheme shows a SIGMA keyboard with in white the keys used for the PC key board and trackball and their affectation The keys in grey
200. e or cancel your option 10 12 01 OPERATING INSTRUCTIONS 3 19 PRINT Select With the PRINT select key the user can assign the PRINT2 key of the keyboard and the PRINT key on the remote control to following functions Assign PRINT2 key to Nothing 1 2 Colour Video Printer 3 Archiving Cancel Nothing PRINT2 key has no function press alphanumeric key 1 Colour Video Printer If PRINT2 is assigned to the Colour Video Printer the key gener ates a remote signal for a colour video printer which can be attached only to SIGMA 330 systems press alphanumeric key 2 Archiving PRINT2 key acts as save key if KIPRISM is installed on the system and a for matted Flashcard is entered in the slot press alphanumeric key 3 The actual image is stored in memory by pressing the PRINT2 key If the KIPRISM option is enabled the default action is set to the image storage In this case The user can save images when the machine is in LIVE mode a beep is generated if there is no space left on the memory card or if the flash card system is not correctly formatted Press the character corresponding to the first letter of the strings in the buttons to validate or cancel your action Then the next dialogue box appears Assign Remote Controllers PRINT key to Nothing Black amp White video printer Colour video printer
201. e renting information SIGMA 110 SIGMA 330 10 12 01 3 7 Major Modes SIGMA 110 can include four major imaging modes 2D TM PW CW PW and CW are optional SIGMA 330 can include five or six major imaging modes 2D TM PW CW CFM and additionally 3D on SIGMA 330 Excellence CFM and 3D are optional 3 7 1 20 Mode Press 2D key to select 2D mode see figure 1 4 Keyboard on page 1 13 to locate the key Note This mode is automatically set when the instrument is switched ON if no personal setup has been previously defined and if the probe which is automatically selected by the system is able to do 2D 3 7 1 1 2D Mode Selection The legend used to identify the image state in the following pictures is shown below no ultrasound image shading filling for live image shading filling for frozen image shading filling for refreshed image this symbol shows the LEFT RIGHT scanning direction this symbol shows the selected image live image or latest frozen image this symbol shows that image is frozen trackball iv Figure 3 1 2D Mode Selection 10 12 01 OPERATING INSTRUCTIONS 3 25 3 26 2 2 77 2727 74 7 22222227 Qa 7 7 77 7 7 7 74 27227 2 7474 77274247 244444 7 ERRERA Figure 3 2 Double 2D Selection SIGMA 110 SIGMA 330 10 12 01 477 447 PPP
202. ead up Head face Head 7 111 AVA KONTRON DICAL M L 3 Obstetrics Gynaecology N 4 e 7 8 7 x Body female 8 3 2 Body pregnant 9 Body pregnant right 10 Body pregnant left 11 3 Foetus 1 4 Cardiology A set of 10 body markers is available in Cardiology No scan direction is needed for this type of body markers 7 112 Parasternal long axis 6 Q Mitral valve level 7 gt Papillary muscle level 8 High short axis 9 9j Apical four chamber view 10 ger SIGMA 110 SIGMA 330 Foetus Foetus Foetus Foetus back Foetus back Apical two chamber view Subcostal four chamber view Parasternal short axis Subparasternal application parallel Subparasternal application trans verse 15 10 01 Appendix Acoustic Output Tables M 1 Track3 Summary Tables In the following tables each transducer mode combination for which the global maximum dis played MI and or is greater than 1 0 is checked with a For these combinations details are given in the Acoustic Output Reporting Tables in section L 3 Shaded fields are combinations which are not supported by SIGMA 110 330 Table 7 1 Track 3 Summary Table Possible Operating Modes Mechanical Scanheads Transducer Model 7 5 GP 6 5 EV Operating modes B Mode M Mode PW Doppler CW Doppler Color Doppler Combined Other
203. eakage cur rent has demonstrated that a electrical safety has not been compromised It is also necessary to insure that the probe has not been cracked or damaged so that it produces erroneous scans Do not immerse the entire probe in liquids to clean it The probe is not watertight and immer sion may compromise the electrical safety features of the probe Carefully follow the cleaning instructions in this manual Take all appropriate precautions to avoid impact damage to the sensitive face of the probe The use of products not approved by KONTRON MEDICAL such as oil Methylene blue ether or some disinfectants could cause permanent damage to the sensitive part of the transducer Only the KONTRON MEDICAL supplied gel KONTRON supply part number 100 250 ultra sonic gel is recommended by KONTRON MEDICAL for coupling the transducer to the skin The use of an agent other than the approved gel may adversely affect the quality of the images and produce substandard results The cart available with the SIGMA 330 Expert and SIGMA 330 Excellence provides insulated plugs and connectors to manage optional hard copy devices VCR printers Follow the instructions in this manual to install such a device Wrong connections may compromise the electrical safety of the system Never connect additional peripherals directly to wall outlets use a medical grade isolating transformer which must comply with IEC 601 1 specifications Wrong connections may com prom
204. ed at their delivery Peripherals must be placed in their original package provided at their delivery a Before carrying the SIGMA 330 Expert or SIGMA 330 Excellence unit follow these instruc tions 1 Disassemble the upper part Monitor which is attached on the top of the cart 2 Remove the flat screen attached on the side of SIGMA 330 Excellence 3 Remove the integrated computer from SIGMA 330 Excellence 2 6 SIGMA 110 SIGMA 330 10 12 01 4 KONTRO MEDICAL 2 6 Installation of SIGMA 330 Expert and SIGMA 330 Excel lence 2 6 1 Installation of the integrated cart After unpacking to assemble the SIGMA 330 Expert or SIGMA 330 Excellence unit a place the upper part on the cart a connect the following cables 1 Reference 412 139 power cable labelling ECHOGRAPHE 2 Reference 411 353 mains cable 3 Reference 481 068 Footswitch For connecting the other cables see Chapter 2 9 Connection of Peripherals on page 2 15 a fasten the two milled screws 7 inside the cabinet dedicated to VCR Front view see fig ure 2 1 Installation of SIGMA 330 Expert or SIGMA 330 Excellence on page 2 7 Figure 2 1 Installation of SIGMA 330 Expert or SIGMA 330 Excellence 10 12 01 INSTALLATION 2 7 AVA KONTRON MEDICAL 2 6 2 Installation of the flat panel monitor After unpacking to assemble the monitor on the unit a place the monitor on its holder and tighten the screw make firm the cables with b
205. ed in this document Status messages have no effect on the system but inform the user of a bad manipula tion Warnings signify to the user that the system is in an incorrect state or that the user has performed a non authorized action Errors inform the user of a system failure due to hardware problems broken board or software failure 5 2 3 Remarks The different messages warnings and errors are displayed in English Doppler board is either SP DOP or COL DOP board 5 4 SIGMA 110 SIGMA 330 15 10 01 5 3 Status Messages 5 3 1 ECG When ECG mode is active different error cases can be detected the different ECG warning messages are always displayed on the bottom right side of the screen in red Date amp Time General information and Patient name Technical data Grey scale Meas result L gt o4 od d d A n alio lil pne d ll l ll EGG message f f I I j Zoom indicator it Mon 5 3 1 1 ECG Activation There are two ways to activate the ECG mode the user should load the cardio setup for the current probe switch the ECG ON via the PREF menu 5 3 1 2 ECG Message Q zoomt rea 19 808 NO EGG is displayed when ECG mode is active and e ECG is not connected or not correctly connected there is a defect serial
206. ed mode violation is detected CPU registers and interrupt number are displayed in the dialogue box If this message is displayed the user must send this information video printout to the service team This will help the development team to correct the problem Error 0 Fatal Error CS EIPOOCXXXXXXXX ESP XXXXXXXX EFL XXXXXXXX EAX XXXXXXXX EBX XXXXXXXXX EDX XXXXXXXX EDI XXXXXXXX EBP XXXXXXXX b 5 5 2 Error 1 Can notrestore backed up configuration Error 1 Can not restore backed up configuration The flashcard content is not compatible with the current software version ES This message is displayed when the user tries to restore from a flashcard a backed up configura tion that is not compatible with the current software version The configuration must be set manually by the user and saved again on the flashcard 5 18 SIGMA 110 SIGMA 330 15 10 01 5 5 3 Error 2 Tracking problem Fatal error In case of a fatal error due to a transducer or a hardware problem the following message is dis played and the system will be shut down after the user acknowledge the message Error 2 Fatal error Your transducer does not track the intended position Please signal this error to your service team System will be shut down ES Different causes can produce this error e Endocavity probe temperature exceed 41 C cool the transducer and restart the
207. ed on the keyboard are listed below and shown in figure 1 4 Keyboard on page 1 13 Remote control unit location Power ON OFF key Potentiometer joined to function menus Alphanumerical keys MENU key Menu function keys joined to menus displayed on screen MENU PREVIOUS NEXT keys Time Gain Compensation TGC Function keys 2D TM gain CFM PW CW gain Depth FREEZE key Validation SET keys joined to the trackball 3 independent keys Trackball GU CM SOE Odo pU cx ln ln o O A 0 1 12 SIGMA 110 SIGMA 330 15 10 01 Figure 1 4 Keyboard 15 10 01 INSTRUMENT DESCRIPTION 1 13 H 4 TRON MED ICAL 1 3 2 2 Remote Control Unit It allows the remote control for main scanning parameters freeze and image printing The main advantages of the remote control are System control in any inadequate examination condition Usage in operating room because it can be easily disinfected Operation in difficult environment Group demonstration or lesson D e A IR ww TT n Figure 1 5 Remote Control Unit The different keys available on the remote controller are the following poem Ot 10 11 12 13 MAGNIFY SCROLL SP 4 DEPTH ON OFF BASELINE FREQ VELOCITY CW PRINT 2D CFM PW TM FREEZE key GAIN Trackball keys Magnify the ultrasound image by a factor 2 Scrolling in Trace
208. edical Application e Isppa lt 190 W cm2 Medical Application independent e Im lt 310 W cm2 Medical Application independent 15 10 01 INSTRUMENT DESCRIPTION 1 61 e Ispra In situ in mW cm is shown in the table below 2 CARDIO VASC RADIO OB GYN Ispra In situ in mW cm lt 430 lt 720 lt 94 Table 1 7 Acoustic Intensity Accuracy of MI display 30 Accuracy of TI display 50 1 8 15 Environment TEMPERATURE Operating temperature 10 C to 40 C 50 F to 104 F Storage temperature 20 C to 40 C 4 F to 104 F HUMIDITY Operating humidity 30 to 80 non condensing Storage humidity 30 to 95 non condensing ATMOSPHERIC PRESSURE Operating pressure 700 mbar to 1060 mbar Storage pressure 500 mbar to 1060 mbar ELECTRICAL SPECIFICATIONS Input voltage 100 127 and 200 240 V Mains frequency 50 60 Hz Consumption 340VA main unit only 680 VA with integrated cart and peripherals ELECTROMAGNETIC FIELD Maximum field strength without degradation of performance 1 V m 1 8 16 Regulation and Safety CE MDD mark German regulation EC 601 1 Class 1 Type B Electrical Safety EC 1157 Acoustic power reporting FDA 510 k 1 8 17 Dimensions SIGMA 330 Master Height 380 mm e Width 470 mm Depth 526mm Weight 29 kg 1 62 SIGMA 110 SIGMA 330 15 10 01 SIGMA 330 Expert Height Width Depth Wei
209. ee Chi For ewe fen uds the LOGIN window The default user name is sigma with the sigma password Biton NT Pape T Cogon ume pain conection ime men geome Please contact your local KONTRON MEDICAL representative to change the user name and or the password or to log on the system as Administrator 3 20 9 PC power off During the shut down process requested by the user commands are sent throughout the USB interface SIGMA sends a CTRL ALT DEL key sequence to the PC and then waits for the PC shut down completion At this moment the user is responsible of closing and saving his documents He can use the SIGMA keyboard and trackball which are automatically affected to PC mode Select Shutdown in the different dialogues displayed EL de joo ever Hrs c poe Po ded ping prd oss dados so Par wo cari ed When the has finished its shutdown process the SIGMA system is automatically powered off 3 114 SIGMA 110 SIGMA 330 10 12 01 3 20 10 3D and 3D FetalViewHl The settings have been specially adapted to easily control the 3D software directly from the SIGMA using menu keys or the footswitch This chapter describes only these shortcuts For more information about the 3D software refer to the User Manual of the 3D software deliv ered with the
210. ee Chapter 2 9 10 1 Printer settings on page 2 26 10 12 01 OPERATING INSTRUCTIONS 3 21 Foot Pedal Foot Pedal allows the user to select the action associated to the left pedal of the footswitch The right pedal is always assigned to FREEZE UNFREEZE Action associated to left footswitch pedal 1 Print 2 Image select Cancel Q PCMCIA Card PCMCIA allows the user to select the option Read only or Full access for the PCMCIA memory card Data stored on PCMCIA Card are 1 Read only accessed 2 Full accessed required for PACS Cancel 3 6 5 5 Time The system displays the current time Using the Time menu the user can modify the current time of the system The Time menu includes Hour Minute Second Validate and Abort keys Hour Abort Press Time F5 Press Hour F1 Rotate the softpot to get the right hour 4 Then press Validate F4 Proceed similarly for changing minute and second To modify the hour e g N gt 3 22 SIGMA 110 SIGMA 330 10 12 01 3 6 6 PCMCIA CARD Backup Restore List Format Battery Config Config Content Check The system offers the possibility of saving and restoring user configurations using a PCMCIA memory card This is very useful in case of multi application and multi user each physician using the system can get a personal memory card to store hi
211. electrodes 2 22 SIGMA 110 SIGMA 330 10 12 01 2 9 8 Colour Monitors 2 9 81 Connection of Colour Monitors SIGMA 330 features an output port dedicated for an additional video monitor The following configurations are shown in figure for recommended colour monitors Additional Colour Monitor Flat Panel Colour Monitor EYE Q 300M Figure 2 16 Connection of additional Colour Monitor 1 DC power Input 12 V for EYE Q 300M 2 Reference 485 659 signal cable for EYE Q 300M 3 Reference 485 861 signal cable for CABEL Reference 479 764 signal cable for SONY PVM 14M2MD or equivalent 10 12 01 INSTALLATION 2 23 4 HA MEDICAL 2 9 8 2 Settings for Flat Panel Monitor EYE Q 300M For optimizing the image quality the following settings are recommended and set in factory EYE Q 300M VGA S VHS Settings Contrast 68 Luminosity Back Light 7 Brightness 95 Size Mode variable Red 51 Colour Coordinates Green 56 Blue 57 OSD Settings Colour Resolution INTL Video Mode VTR IN3 Saturation Colour Control Hue Table 2 8 Settings for Flat Panel Monitor EYE Q 300M The Luminosity setting Contrast Back Light and Brightness should be set by the user in accordance with environmental conditions In the Setting Mode OSD On Screen Display the settings can be made using the operating keys 7 Figure 2 17 Colour Monitor EYE Q300M 2 24 SIGMA 11
212. elocity E wave on Peak Velocity A wave Stroke Volume in millilitres Stroke Volume Index in millilitres per square meters Cardiac Output in litres per minute Cardiac Output Index in litres per minute per square meters c Heart rate TM or SP measurement HR Patient heart rate in beats per minutes on mitral valve This field is used for the computation of the mitral valve study sheet d Mitral Valve Effective Opening Area Continuity Equation SAD gt SAA VTlaov VTImv gt EOA Sub Aortic Diameter in cm Area in cm2 computed from DiamAOV Sub Aortic Velocity Time Integral in cm Velocity Time Integral at Mitral Valve in cm Mitral Valve EOA in cm2 computed from VTlaov and VTImiv Pressure Half Time PHT PkVE gt EOA Pressure Half Time in millisecond Peak Velocity for E wave in m s Valve Area in cm2 computed from Pressure Half Time D 2 3 Equations a SP study e Velocity Time Integral VTI in cm Vi Df f 15 10 01 VII Vj At 2 fo cosa vD Velocity in m s during each Dt in s of measured spectral area Doppler frequency in Herz Sound velocity 1540 m s Ultrasound frequency in Herz Angle between the ultrasound beam and blood velocity APPENDICES 7 19 AVA KONTRON MEDICAL e Pressure Time Integral in seconds per mmHg PTI PIE Py At P Dav Pi Pressure in mmHg during each Dt in s of the velocity spectrum Comp
213. enu STORE and ARCHIVE functions are available from every freeze menu in all modes Press FREEZE key to display the following menu a a a XXXX XXXX Store XXXX XXXX active The STORE key stores the current image displayed on the SIGMA screen in the memory card This key is automatically disabled if there is no space left on the memory card or if the memory card does not use the KIPRISM format The ARCHIVE key enters the archive mode This key is automatically disabled if no data are stored in the memory card if the memory card does not use the KIPRISM format or no card is inserted The PRINT 2 key of the user interface can be configured to store images on memory cards In the setups the user can select the action of this key print on a colour video printer or save on the memory card If the KIPRISM option is enabled the default action is set to the image storage on memory card If the PRINT 2 key is associated to the memory card e The user can save images when the machine is in LIVE mode A beep will be generated if there is no space left on the memory card if the memory card does not use the KIPRISM format or no card is inserted If the memory card format is not valid a dialogue box offers the possibility to format it For format ting a memory card refer to Chapter 3 6 6 PCMCIA CARD on page 3 23 10 12 01 OPERATING INSTRUCTIONS 3 51 To store an image
214. enuation coefficient established by the FDA 0 3 dB cm MHz Over estimation of actual In Situ exposures is thus part of the calculation process A number of factors influence the estimation of the accuracy of the displayed indices the most significant ones being the variability between probes and the laboratory measurements accuracy 15 10 01 GENERAL INFORMATION XXV H 4 KONTRON MEDICAL hydro phone operator algorithms etc itself while variability of the system pulser and effi ciency is a minor contributor The accuracy of the measurement of the centre frequency is estimated to be 2 of the acous tic pressure to be 16 of the acoustic power to be 10 and of the acoustic intensity to be 3296 The accuracy estimate based on the variability range of probes and systems and on the inher ent modelling and the above mentioned measurements errors ranges from 30 for the MI index to 50 for the TI index The SIGMA 110 330 Maximum Acoustic Output As per the AIUM standard the tables in Appendix M Acoustic Output Tables list the maximum TI Thermal Index and MI Mechanical Index values for each probe and mode of operation The system screens display the recently adopted MI which is now considered a better relative indicator of non thermal bioeffect mechanisms The SIGMA 110 330 maximal MI is 1 9 which FDA has recognized as equivalent to pre amendments Isppa limits The SIGMA 110 330 maximum output for Ispta is limited
215. epending on depth angle and medical application SIGNAL PROCESSING e Large bandwidth 1 5 18 MHz Overall Gain 32 steps Time Gain Compensation 5 sliders Dynamic focusing on reception Up to four focus zones on transmission Automatic adjustment of reception bandwidth for each depth Contour enhancement 7 positions application dedicated Dynamic range control reject 4 positions to increase the contrast and reduce weak echoes Frame filter 4 non linear smoothing filters OFF position Automatic Frequency Adjustment A F A for standard and less echogenic patient Freq Freq Grey scale optimization thanks to 8 Gamma curves probe dependent IMAGE PRESENTATION Single Double and Quad image representation Freeze mode e Left right Up Down Video inversion RESOLUTION e 512 x 512 pixels on screen for 2D image display 256 grey levels IMAGE MEMORY option Cine Mode up to 282 images probe and medical application dependent 1 7 3 TM M Mode SIGNAL PROCESSING Same as 2D mode IMAGING PARAMETERS Scrolling speed 1 46 SIGMA 110 SIGMA 330 15 10 01 2 3 5 8 sec screen screen e 1 1 5 2 5 4 sec screen 2D TM M LINE STEERING Trackball controlled over complete 2D sector DISPLAY 2D 50 screen TM 50 screen Full screen TM IMAGE MEMORY Cine Mode up to 16 trace screens in full TM up to 5 trace screens in 2D TM 1 7 4 Spectral Dopp
216. er within the SIGMA 110 330 limits the user may override the application specific limits if clinically required The user is responsible for being aware of the output level that is being used The SIGMA 110 330 real time output display provides the user with relative information about the intensity level The Mechanical Index The Mechanical Index MI is defined as the Peak Rarefactional Pressure in MPa derated by a tissue attenuation coefficient of 0 3 dB cm MHz divided by the square root of the probe central frequency in MHZ With the MI the user can keep the potential for mechanical bioeffects as low as reasonably achievable while obtaining diagnostically adequate images The higher the index the larger the potential However there is no level that indicates when Bioeffects is actually occurring The Index is not intended to give an alarm but are an aid in implementing the ALARA principle The Thermal Index The purpose of the Thermal Index is to keep the user aware of conditions that may lead to a temperature rise under certain defined assumptions It is the ratio between the total acoustic power to the power required to raise tissue temperature by 1 C estimated on Thermal Models There are currently three Thermal Indices each based on a specific Thermal Model used to estimate temperature rise whether at the surface within the tissues or at the point where the ultrasound is focusing on bone 1 The Soft Tissue The
217. er 1 5 3 2 2D and 2D TM Technical Data on page 1 39 1 5 38 CFM TM Technical Data See Chapter 1 5 3 3 2D TM Technical Data on page 1 39 1 40 SIGMA 110 SIGMA 330 15 10 01 1 5 3 9 Technical Data The CFM information is inserted in the 2D SP techdata 2D SP 2Di SP Technical Data on page 1 40 Probe Sub Application Depth Resolution CFMFreq Color Map 2D Gain PW CW SPFreq SPWall Filter GateSize Probe Subappl Low Mhz ColMapx BGainxx PW MHz WxxxxHz Gatexxmm TI xx x name Appl name CGainxx Pers x xx fps En xxdB DGainxx Vectxx En xxdB Application CFM Gain Persistence Frame Rate CFM Energy Doppler Gain Vector SP Energy a PW mode only b in live mode only When the Color Off key is pressed the 2D SP technical data are displayed Chapter 1 5 3 6 1 5 3 10 CFM SP Technical Data Chapter 1 5 3 6 2D SP 2Di SP Technical Data on page 1 40 15 10 01 INSTRUMENT DESCRIPTION 1 41 1 6 Display Modes 1 6 1 2D Modes 2D single 2D 2D 2D dual Quad 2D zoomed zoomed area image area L p M L _ ON f KK magnified 2 5 1 i Mechanical zoom Magnified 2D Linear zoom only
218. er Gamma Default From here the user tune the printers gamma and correct the output image The user change both contrast and brightness He saves its setup by leaving the Printer Setup menu 10 12 01 INSTALLATION 2 31 H 4 KONTRON MEDICAL 2 9 11 Connection with medical grade isolators When required KONTRON MEDICAL can provide medical grade isolators on request In case of doubt for more details to connect additional peripherals contact your local distributor See also Chapter 2 1 Electrical Safety on page xix and Chapter 2 9 1 Electrical safety with peripherals on page 2 15 Printer Port Isolator 489859 PC Printer 110 220 VAC 110 220 VAC Figure 2 22 Connection with isolating accessories 1 Reference 490 199 Cable DSUB 25 M F L 1 5 m 2 Reference 870 072 Cable PC Printer L 1 8 2 32 SIGMA 110 SIGMA 330 10 12 01 2 9 12 Connection with S Video Distributor When required KONTRON MEDICAL can provide medical grade isolators on request In case of doubt for more details to connect additional peripherals contact your local distributor See also Chapter 2 1 Electrical Safety on page xix and Chapter 2 9 1 Electrical safety with peripherals on page 2 15 1 2 Adaptor S VIDEO 489689 Distributor 490024 LCD Flat Panel Repetition Monitor 110 220 VAC 110 220 VAC Figure 2 23 Connection with isolating accessori
219. er cursor position SIGNAL PROCESSING 1 56 SIGMA 110 SIGMA 330 15 10 01 Doppler frequencies 2 3 4 and 8 MHz probe dependent Velocity range PW 1 kHz to 10 kHz CW 1 kHz to 20 kHz Doppler shift PRF 2 10 cm sec to 3 5 m s PW 7 2 m sec CW full scale depending on probe and operating frequency High pass wall filter 10 cut off frequencies adjustable between 50 to 1000 Hz Grey scale optimization with 8 post processing curves probe dependent Spectrum gain control 11 selections between 0 and 30 dB 120 dB dynamic range for best sensitivity 256 point FFT computing time of 0 2 ms Doppler transmit power control 8 selections between 0 dB and 21 dB Doppler angle correction from 80 to 80 Scrolling speed 2 3 5 8 sec screen full screen 1 1 5 2 5 4 sec screen 2D SP e Adjustable audio volume e ris colour system PW GATE PW gate adjustable for sample volumes between 1 and 15 mm 8 selections PW gate adjustable with the trackball between 0 and maxi depth of the image format DISPLAY 2D 50 screen Doppler 50 screen 2D icon Doppler Base line shift 9 positions for optimal signal display avoiding spectrum aliasing e Vuean real time trace display e and Vmax real time trace display Quasi duplex automatic refresh 4 levels according to scrolling speed IMAGE MEMORY Cine Mode up to 16 trace screens in full Doppler up to 5 trace screens
220. es Reference 481 076 signal cable for S VHS VCR Reference 441 562 S VHS signal cable for EYE Q 300M 10 12 01 INSTALLATION 2 33 2 34 This page is intentionally left blank SIGMA 110 SIGMA 330 10 12 01 10 12 01 3 OPERATING INSTRUCTIONS OPERATING INSTRUCTIONS 3 2 SIGMA 110 SIGMA 330 10 12 01 3 1 Operating Precautions If the SIGMA 110 330 is being plugged in for the first time refer to Chapter 2 7 Power Source Connection on page 2 10 Connect the mains inlet connector to a suitable supply source Make sure that the power line supply complies with the voltage selected on SIGMA 110 330 Be certain that the power source receptacle is a 3 pin socket with the third pin grounded Note The unit can be connected to the patient s bed by using the equalization potential terminal Chas sis Ground see figure 1 10 SIGMA 330 Expert rear panel on page 1 23 Check the connections of transducers auxiliary and optional equipment such as recorders VCR printers and other peripherals Make sure that connections are properly and securely made and that cables and connectors are in good condition Cables free of unnecessary stress or friction for the length of the cable Cables covering and insulation undamaged Connectors secured at the cable end and matching securely at connection 10 12 01 OPERATING INSTRUCTIONS 3 3 AVA KONTRON MEDICAL 3 2 Switching the Instrument ON 3 2 1 Swit
221. et the default measurements are the following ellipsoid volume using a coefficient of 0 523 V D 5 p1 D2 D3 coefficient 0 523 D1 Distance 1 in millimetres D2 Distance 2 in millimetres 3 72 SIGMA 110 SIGMA 330 10 12 01 D3 Distance 3 in millimetres V Volume in cm thyroid volume using a coefficient of 0 479 V 479 1 2 3 coefficient 0 479 D1 Distance 1 in millimetres D2 Distance 2 in millimetres D3 Distance 3 in millimetres V Volume in cm 3 14 3 6 Ratio The ratio computation is a special measurement related to the last measurement e g if the user has made a distance measurement by using the Ratio key the user will make a second distance measurement and the ratio between the first distance measurement and the second one will be automatically computed The 2D ratio calculation is available for the Distance measurement Area measurement Ratio on 2D distance measurement Technical Data For the ratio on a 2D distance measurement the result of the distance measurement and of the distance ratio measurement is displayed Ratio on 2D area measurement Technical Data NV L Lob 10 12 01 OPERATING INSTRUCTIONS 3 73 For the ratio a 2D area measurement the values of the area result and of the area ratio meas urement is displayed 3 14 3 7 Specific 2D Ob Gyn Measurement The specif
222. eter in cm Weight foetal weight in grams 1 Shepard M J et al An Evaluation of Two Equations for Predicting Fetal Weight by Ultrasound Ameri can Journal of Obstetrics and Gynaecology 1982 Volume 142 Page 47 15 10 01 APPENDICES 7 39 Campbell method dependency on Abdominal Circumference measurement The foetal weight is accessed from the reference table shown below AC cm Weight g 21 900 130 25 1510 210 31 2690 370 36 3640 490 38 3920 540 40 4100 580 AC Abdominal circumference in cm Woo method dependency on Abdominal Circumference and Biparietal Diameter measurements log Weight D 1 13 00 18 BPD 00 05 AC 3 35 1000 Abdominal circumference BPD Biparietal Diameter in cm Weight foetal weight in gramms Hsieh method dependency on Abdominal Circumference and Biparietal Diameter measurements D 5 6541 AC BPD 1 5515 AC BPD 1 9782 AC 0 52594 BPD 1000 10000 log Weight OBS oen 100000 100 0 02 13153 Abdominal circumference BPD Biparietal Diameter in cm Weight foetal weight in gramms 1 Campbell D Wilkin Ultrasonic Measurement of Fetal Abdomen circumference in the estimation of fetal weight British Journal of Obstetrics and Gynaecology Sept 1975 Volume 82 No 9 pages 689 to 697 2 Clinical Validation of Two Equations in Antenatal Prediction of Chinese Fetal Weight by Ultrason
223. ex Label MI PAPER Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value a lt 1 0 lt 1 0 b Pr3 MPa 2 Wo mW min of W 3 z1 lrA 3 21 mW 21 cm a bp E Zsp cm 8 deq Zsp cm 5 fe MHz 2 Sie GEA X cm Im O 2 PD msec 6 PRF Hz S Pr PIlmax MPa 5 deq Pllmax cm L th FL cm ocal Len E FL 3 Ip 3 MImax W cm depth frequency focus 9 Notes a This index is not required for this operating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is not reported for the reason listed 7 130 SIGMA 110 SIGMA 330 15 10 01 H 4 KONTRON HINMEDICAL Transducer Model 5 0 LV Operating Mode PW mode TIS TIB TIC non scan Index Label MI non sgar Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value a 1 7 3 2 b Pr3 MPa 2 Wo 142 1 min of W 3 z1 IrA 3 z4 mW 85 0 Gi cm 1 82 A bp 1
224. external printer To do this he must press the J 3 Save the Report on Flashcard The user can store the report in a text file on the flashcard To do this the KIPRISM option must be enabled and he must press the icon 7 94 SIGMA 110 SIGMA 330 15 10 01 H 4 KONTRON MEDICAL Appendix K KIPRISM SonoWin Basic Conversion Tables K 1 Overview This section describes the correspondance between the SIGMA measurement values and the SonoWin Basic ones These correspondances are shown in tables sorted by medical applica tion and have to be read as shown below Description SIGMA Sono Win Chapter Long Axis Length at diastole LALd cm LVLD mm Card 2D LV Single Plane Description as found in SIGMA SonoWin The package where Appendix D to H sections measurement measurement the measurement is name and unit name and unit stored in Sono Win database K 2 Cardiology Measurements K 2 1 Left Ventricle study K 2 1 1 2D measures Single Plane Description Sono Win Chapter Long Axis Length at diastole LVLD Card 2D LV Single Plane Long Axis Area at diastole LVALD Card 2D LV Single Plane Long Axis Length at systole LVLS Card 2D LV Single Plane Long Axis Area at systole LVALS Card 2D LV Single Plane Diastolic Volume EDV Card 2D LV Simpson s Rule Systolic Volume ESV Card 2D LV Simpson s Rule Ejection Fraction EF Card 2D LV Simpson s Rule Stroke Volume
225. eys M1 M10 Mag Mark Icon Figure 1 14 Screen Layout 1 5 1 1 General information and Date amp Time In this area following information are displayed the laboratory references the operator name the patient name the current date and time Laboratory Operator Date Time v Patient Name A information fields According to the user preferences set in the setup menu the content of the general information fields can be displayed or not These fields are set in the Patient ID form The content of the laboratory and the operator fields are saved in the Non Volatile RAM and dis played at each start up 15 10 01 INSTRUMENT DESCRIPTION 1 33 AVA KONTRON MEDICAL 1 5 1 2 Colour Grey Scale According to the current mode 2D or CFM mode the colour and or the grey scales are dis played on the left part of the screen The display rules of both scales are the following scales are never displayed in full TM mode scales are displayed in all the other modes when no overlapping between the scales and the ultrasound image is possible scales have an height of 128 pixels in single 2D or CFM and 80 pixels in the other modes a The grey scale From the 128 CFM mode or 256 2D mode ultrasound possible grey levels only 16 are displayed in the grey scale Remark in CFM mode the displayed grey scale has the half of the width of the grey scale displayed in 2D a The colou
226. for cost and cabling reasons Never connect additional peripherals directly to wall outlets if no medical grade iso lating device provides a galvanic isolation between the peripheral and the ultra sound system Use a medical grade isolating transformer which must comply with IEC 601 1 specifications Wrong connections may compromise the electrical safety of the system See also Chapter 2 1 Electrical Safety on page xix It is recommended to turn the system OFF before connecting any peripheral 2 16 SIGMA 110 SIGMA 330 10 12 01 2 9 22 Recommended Peripherals The following peripherals are recommended for use in SIGMA 110 330 Systems Black amp white Video Printer MITSUBISHI P91E e SONY UP890MD SONY UP895MD Colour Video Printer MITSUBISHI CP700E SONY UP 2300 S VHS Video Cassette Recorders PANASONIC SVHS AG MD830E PAL 220 V PANASONIC SVHS AG MD830 NTSC 110 V SONY SVO 9500MDP a Parallel Printer Parallel printer compatible with PCL level Ill language HEWLETT PACKARD Deskjet 930C HEWLETT PACKARD Deskjet 970Cxi HEWLETT PACKARD Deskjet 990Cxi External colour Monitor Eye Q 300M flat 15 TFT colour monitor CABEL C34N48X15H90A SONY PVM 14M2MD or equivalent A standard B amp W VCR PAL or NTSC and an external standard B amp W monitor PAL or NTSC can be connected to the SIGMA 330 and SIGMA 110 systems For using any other peripherals than those above me
227. from SIGMA to the same SonoWin value is intended because mostly only one of these is used If in rare case there is a need for a customer to use two or more of these values simultaneously he can assign them to user defined measurements and proceed as described below a Open the measurement table click a Open Configuration in the system menu a Mark the chapter where an item has to be add or create a new chapter Add the item s Close this window Assign the transferred values to the newly defined measurements by clicking on Please refer to SonoWin 2000 User s Manual for more details 10 12 01 OPERATING INSTRUCTIONS 3 109 3 20 Integrated PC SIGMA 330 Excellence 3 20 1 Overview The SIGMA 330 Excellence includes a high end PC running Microsoft Windows 2000 Profes sional the keyboard and trackball of the SIGMA can be used as a standard PC keyboard and PC mouse the Universal Serial Bus USB interface is used to perform the communication link between the SIGMA system and the integrated PC The following drawings show the PACS configuration and 3D tool configuration O LCD monitor Keyboard trackball and SIGMA 110 330 images data USB interface PC with PACS Frame Grabber Video signal 7 LCD monitor SIGMA 110 330 Keyboard and trackball data USB interface with 3D
228. ght SIGMA 330 Excellence Height Width Depth Weight 15 10 01 1230 mm min 1305mm max 580 mm 684 mm 90 kg 1230 mm min 1305 mm max 580 mm 684 mm 103 kg INSTRUMENT DESCRIPTION 1 63 1 64 This page is intentionally left blank SIGMA 110 SIGMA 330 15 10 01 10 12 01 2 INSTALLATION INSTALLATION 2 2 SIGMA 110 SIGMA 330 10 12 01 2 1 Installaton Requirements Be sure that the site is sufficiently ventilated and do not install the instrument near any important heat source In order to prevent an overheating ensure that the ventilation openings are not covered and keep the rear panel away from a vertical wall Bring the package relief as close as possible to the required operating location It is recommended to provide two people for removing SIGMA 110 330 from its package 2 2 Unpacking 2 2 1 Warning Installation must be performed by authorized KONTRON MEDICAL SAS personnel Any attempt by unauthorized personnel to install the instrument may invalidate the KONTRON MEDICAL SAS warranty If the instrument is received in damaged conditions request an immediate inspection by the car rier and local KONTRON MEDICAL representative 2 2 2 Unpacking the Instrument SIGMA 110 and SIGMA 330 instruments are packed in non returnable packings 2221 SIGMA 110 Light Master and SIGMA 330 Master These models are packed in a cardboard box Remove it carefully 2 2 2 2 SIGMA 330
229. gy ce oe D dee CW menu is similar to the PW menu except Gate Size which is not significant in CW Doppler not be selected a Steering function is not available See section PW live menu in Chapter 3 7 3 2 PW Live Menu on page 3 36 for details of the dif ferent items page 1 3 7 4 3 CW frozen menu Gamma Store pios o angre arrive See section PW frozen menu in Chapter 3 7 3 3 PW Frozen Menu on page 3 37 for details of items See 2D frozen menu in Chapter 3 7 1 3 2D Frozen Menu on page 3 30 3 7 44 CW Doppler Audio Amplifier SIGMA 330 and SIGMA 110 include a stereo amplifier with associated loudspeakers to amplify Doppler audio signal Volume is adjustable by rotating the uppermost knob on the left side on the front of the monitor housing 10 12 01 OPERATING INSTRUCTIONS 3 41 AVA KONTRON MEDICAL 3 7 5 CFM Mode SIGMA 330 can perform Colour Flow Mapping CFM when CFM option is installed and CFM compatible probe is used See table i Probe applications on page xvi for the CFM compatible probes Press CFM key to select CFM mode see figure 1 4 Keyboard on page 1 13 to locate the key 3 7 5 1 Mode Selection Figure 3 7 CFM Mode Selection 3 7 5 2 Sub Application Menu When selecting the CFM mode by pressing the CFM key the sub application menu is displayed first The user can select between the diffe
230. h medical grade isolators 2 32 2 9 12 Connection with S Video 2 2 33 3 OPERATING INSTRUCTIONS cesses 3 1 3 1 Operating Preoaulloris aste hs ciat eun bf edet 3 3 3 2 Switching the Instrument ON ictor eben v te dte rec FER 3 4 3 2 1 Switching ON SIGMA 110 and SIGMA 330 3 4 3 2 2 Switching ON SIGMA 330 3 4 3 2 3 Switching SIGMA 330 Excellence 3 4 3 2 4 dritializauondor SIGMA uice rb tacite ta ta tae OU erie 3 5 3 3 Switching the Instrument 004 4 3 6 3 3 1 Switching OFF SIGMA 110 and SIGMA 0 3 6 3 3 2 Switching OFF SIGMA 330 Excellence 3 6 Gades Cete a 3 7 S41 INOS sero a i ova oan opp pat Ea ette Tt on du 3 7 3 4 2 Menu Key Conventions uite cito eniti edid iet Lee itudin 3 7 3 4 3 Ni rmn 3 7 9 4 4 Men Display 3 7 34 5 Ment aa aiaa 3 8 24522 PRODESs 3 11 3 5 1 Probe Seleollolo det a 3 11 35 2 Menu rec ane paca ree eens 3 11 POM CC 3 13 262 Set
231. haracter cursor or to the list of patients 9 _ a The UPPER SET keys 1 2 f the trackball is assigned to the thumbnails it opens the selected images full screen mode f the trackball is not assigned to the thumbnails it assigns the trackball to the thumb nails and validates the current selection i e the patient selected or the title selected The BOTTOM SET 3 f the trackball is assigned to the title it validates the new title and assigns the trackball to the thumbnails like the UPPER SET key f the trackball is not assigned to the title it assigns the trackball to the title The TRACKBALL To choose an image a patient or character in the title The ENTER key Can be used to validate the title instead of the UPPER SET key or the BOTTOM SET key 10 12 01 OPERATING INSTRUCTIONS 3 53 AVA KONTRON MEDICAL 3 11 2 4 Full Screen Display In this mode the image selected is displayed in its normal size The image stored is inde pendent from the video for mat PAL or NTSC but it depends on the original screen colours B W or Col Our The title of the image is dis played at the bottom of the image above the menu and can be modified as explained before a The Keys 1 to 6 select the SMITH 02 04 01 10 53 35 Technical data sponding image index Left Ventricle ll
232. hat the indices do not con sider TIME exposure the higher your indices the shorter should be the patient exposure Which index when In cardiology vascular and general purpose abdominal small parts exams MI is the primary concern in 2D mode while TIS is the principle index in CFM and Doppler In Ob Gyn the TIB should be considered when scanning a second or third trimester fetus while the TIS is more reliable for earlier exams The TIB is a better predictor during neonatal head studies while the TIC is more significant in adult transcranial studies 11 2 5 Measurement Accuracy on SIGMA 110 330 This is thoroughly discussed in Chapter 1 7 11 on page 1 49 and Chapter 1 8 13 on page 1 60 1 2 6 Glossary and definition of terms Kh Situflintensilies calculations When determining the possible effects of the ultrasound beam on tissue the intensity encoun tered at the tissue site must be calculated Because of attenuation of the beam within the body the intensity at the tissue site in situ may be 10 to 100 times less than if it was measured at the same location in water The amount of attenuation from experience by an ultrasound beam as it travels through the body tissue is determined by three factors 1 Type of tissue along the beam path 2 Frequency of the ultrasound energy 3 Distance covered by the beam In order to achieve a conservative approximation of attenuation due to these three factors the FDA requires the appl
233. he Cardiac Output Diameter field of the vascular study sheet When this field is modified the value displayed in the vascular page is automatically updated and conversely 1 1 2 2 Continuity Equation Diameter This field duplicates the Continuity Equation Diameter field of the vascular study sheet When this field is modified the value displayed in the vascular page is automatically updated and conversely 1 1 2 3 Hip Angle The hip angle is computed either from the Alpha or the Beta field Once a field is selected the sigma switches to the frozen ultrasound image and the angle meas urement starts This measurement is made in three steps step 1 the user places his baseline step 2 the user places his alpha line step 3 the user places his betaline The hip angle is then computed and the ultrasound image remains displayed Here the user can correct the computed alpha and or beta angles This correction is needful to balance careless mistakes In fact there are two values to define an angle between two lines In the above example a and b defines the same angle formed by L1 and L2 The computed angle depends on the way the lines L1 and L2 are drawn if drawing L1 from C to D and L2 from B to A gives the angle b then drawing L1 from C to D and L2 from A to B will gives the angle a Notice that the following relation is always right a p b b is the complement of a to p The following menu will be displayed while processing t
234. he calliper trackball cursor at desired position and enters text by using alphanumeric keys The number of text annotations is limited to 20 Text LOL 11 COCCOLA LLL qp l OWD a Annotation UMP EE To delete a part of annotation place the cursor on the area to be deleted using the trackball and press Backspace key lt This is an annotation Text LLL Ll l LLL This 5 an annotation This is an annotation LL L Ll Ll a LL 3 31 71 To delete the entire text select Clear Text To validate the text press ENTER line feed is performed or move the trackball for a new location or press Text or ANNOTATE to exit 3 12 4 Labels From the main ANNOTATION Menu the user can enter predefined text Labels 3 12 4 1 Create a Label List The user can create up to 4 labels lists for each Medical Application each label list can include up to 100 labels but the entire number of labels is limited to 100 3 60 SIGMA 110 SIGMA 330 10 12 01 AVA KONTRO MEDICAL 1 Press Annotate key and MENU NEXT to display the LABEL Menu Left Right Lobe mu ongitudina 9 Thyroid User1 User2 gt List Medical User3 User4 List Cle
235. he hip angle measurement Compl Compl Finish Alpha Beta Meas If the user remarks the Alpha angle is bad because points are set in reverse order then he presses on the softkey1 Complement Alpha and adjusts the Alpha angle 7 90 SIGMA 110 SIGMA 330 15 10 01 4 KONTRO MEDICAL If the user remarks the Beta angle is bad because points set in reverse order then presses on the softkey2 Complement Beta and adjusts the Beta angle When all the angles are correct he presses on the F5 Finish Meas or on the lt CURSOR_SET gt key to return to the biometry screen 1 1 2 4 Left Ventricle Study e When the TM measurement menu is displayed both full and abbreviate version of the left ventricle measurement are available When the user activates a TM measurement on the left ventricle from the cardio report sheet the measurement is done in either abbreviate or full version according to user preference User preferences are defined in the preference menu 1 1 2 5 Automatic Integral Velocity Integral can be made either in automatic or in manual mode The default mode is defined by user in a preference menu In automatic mode the Vmax or the Vmean profile will be chosen according to the current meas urement as described hereunder Velocity Integral Profile Type MVI VMean VMax VMax Table 7 1 While measurement is in progress the user can switch between manual or automatic mo
236. ic Ob Gyn CRL GES measurement can be classified in two groups a the specific measurements which use the distance measurement CRL FML a the specific measurements which use area or ellipse measurement AC HC All these specific measurements work like a distance or an area ellipse measurement So the distance or area ellipse results and the EFA Estimated Foetal Age results computed from the current measurement are displayed 1 BPD 2 00 mm Distance measurement 1 EFA 3 2 wk 2A 177 7 cm2 Area Ellipse measurement 2 AC 1927 cm 2 EFA 6 3 wk Remarks a the EFA is computed according to the current Ob Gyn tables selection made through the Ob Gyn report a the report is automatically updated according to the current measurement a If the user changes its working Ob Gyn tables the measurement pad will be automatically erased to keep coherence between displayed data and Ob Gyn setup report automati cally updated a For more information refer to Appendix F Ob Gyn Studies on page 7 37 2D Ob Gyn measurement menu NWA 15 weeks demon poe Le Lie Loe pee Ellipse Angle voume page 2 Ratio Undo pag 3 74 SIGMA 110 SIGMA 330 10 12 01 4 KONTRO MEDICAL 2D Ob Gyn generic measurement menu NWA gt 15 weeks or unknown LMP Joistance BPD APD THD HuL Undo Ellipse Angle
237. ically limited to the right pad 2D pad for distance meas urement and PW pad for MVI measurement 3 14 6 7 Pulsatility and Resistance Index Measurement Like for the VTI MVI measurement the PI RI measurement can be made in automatic or manual mode the same menu than the integral menu is displayed when pressing on the amp key This measurement is similar to the VMax Integral Chapter 3 14 6 3 Velocity Time Integral and Mean Velocity Integral Measurement on page 3 84 The PI and RI measurements are computed by drawing an integral on the Doppler spectrum and by setting the Diastole point the Systole point is automatically computed and is equal to the Peak Velocity All these results are displayed on the right side of the screen 3 14 6 8 Resistance Index Measurement The measurement is computed by setting two velocities on the Doppler spectrum and the result is displayed on the right side of the screen 1 Press F7 RI to select resistance index measurement 2 Use the trackball to move the first velocity marker to the desired position 3 Press upper left SET key to fix the marker the first velocity is set the second velocity marker is now available 4 Use the trackball to move the second marker to the desired position 5 Press upper left SET key to fix the second velocity marker The result is automatically displayed on the screen 10 LLL 0 8 0 6 04 6 D Do 4 TT GE 5
238. ication of the following formula la Iy exp 0 23 a f z l is the estimated In Situ intensity at the tissue site e I is the intensity measured in water at the distance z measured in cm ais the attenuation coefficient expressed in dB cm MHz f is equal to the acoustic frequency in MHz of the ultrasound beam xxviii SIGMA 110 SIGMA 330 15 10 01 Definition of terms The Acoustic Intensity generated by an ultrasound probe is usually described as follows Ispta The Spatial Peak Time Average Intensity is an ultrasound intensity averaged over time at the point in the acoustic field where the pulse average intensity is at maximum Isppa The Spatial Peak Pulse Average Intensity is an ultrasound intensity averaged over the pulse transmission time at a point in the acoustic field where the pulse average intensity is at maxi mum Imax The Maximum Intensity is an average intensity during the half cycle with the greatest amplitude during the pulse Mechanical Index MI The Mechanical Index is defined as the peak rarefactional pressure in MPa derated by a tissue attenuation coefficient of 0 3 dB cm MHz divided by the square root of the probe central fre quency in MHz Thermal Index TI The Thermal Index is the ratio between the acoustic power and the power required to raise tissue temperature by 1 C estimated on Thermal Models Peak rarefactional pressure The Peak rarefactional pressure p in MPa is temporal pea
239. ike for the measurement page the report page is divided in three parts At the top of the page the patient name is displayed The second part contains the results of the different calculations which has been done by the user These results are sorted by medical application first and by measurement group then For example when the user has made measurement in different medical application he will find first the results of the vascular study measurement then the abdominal study measurements The patient and laboratory information are always displayed at the end of the report preview 15 10 01 APPENDICES 7 93 The following figure give an example of a print preview screen DUBOIS 14 02 01 08 30 31 RADIOLOGY STUDY STENOSIS PERCENTAGE Velocity on the Stenosis 0 42 m s Velocity forward or backward the stenosis 0 62 m s Stenosis Percentage 48 92 STENOSIS INDEX Velocity Time Integral 71 75 Time Average Maximum Velocity 0 94 m s Peak Velocity 1 07 m s Stenosis Index 0 11 VASCULAR VOLUME Diameter 1 6 58 cm Diameter 2 3 28 Diameter 3 4 94 cm Vasc Volume 55 44 cm3 Page 1 3 The print preview will be modified according to printout improvements The third part contains the different tools icons See Appendix B Report Menu on page 7 5 for more information J 2 Print the Report on an External Printer The user can here print the whole study on an
240. in of W 3 24 3 21 1 mW 21 cm A D 6 25 eq 4sp cm 0 42 E A MHZ s 307 o m X cm 1 6 a Dim of Aaprt lt 1 6 PD msec 10 0 6 PRF Hz Pr Pllmax MPa 5 deq QPllmay cm 0 42 Focal Length i 2 FLy cm 3 Wicm application Vasc 5 Doppler frequency MHz 3 gate size mm 8 velocity range kHz 3 2 energy dB 0 Notes a This index is not required for this operating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is not reported for the reason listed 7 116 SIGMA 110 SIGMA 330 15 10 01 H 4 KONTRON BAY MEDICAL Transducer Model 5 0 MHz GP Operating Mode PW mode TIS TIB TIC Index Label MI aha sgar Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value a 10 16 6 Pr3 MPa g Wo mW 32 2 E min of W 3 21 ITa 3 Zz1 mW Gi cm A 20 em 3 29 eq Zsp cm 0 22 i fo MHz 4 10 2 x cm
241. ints like for the acceleration measurement on the Doppler spectrum E o Mitral Valve Area is displayed Press F2 on menu page 2 Mitral to select mitral measurement Use the trackball to move the first marker to the desired position Press upper left SET key to fix the marker the second end marker is now available Use the trackball to move the second marker to the desired position Press upper left SET key to fix the second marker The result is automatically displayed on the screen 1 0 0 8 0 6 0 4 Y 0 2 2 6H TRI v7 22 04 gt 0 6 0 8 CAA 2 Do Pressure Half Time is displayed in ms 10 12 01 OPERATING INSTRUCTIONS 3 89 AVA KONTRON MEDICAL 3 15 Biometry and Report See also Chapter 7 APPENDICES on page 7 1 3 15 1 Biometry Pictograms The pictograms which appear on all biometry report sheets are described in Appendix 7 APPENDICES on page 7 1 3 15 2 Patient Information The patient identification screen contains the information concerning patient and laboratory See Appendix C Patient Information on page 7 7 For each new patient the user must invoke this mode to clear all biometry measurement and results Some data which appears on this screen can be modified in the report data modified in the report are automatically changed on this page The best way to start a new patient study is
242. ion 486191EN 486191 GE 486191FR 4861911T 3D VascularView English German French ltalian version 486531EN 486531GE 486531FR 486531SP SonoWin Lite English German French Spanish version 488798EN 488798GE 488798FR 488798SP SonoWin Basic English German French Spanish version 486 345 Table 6 2 10 12 01 OPTIONS AND ACCESSORIES Flat LCD 15 screen repetition monitor Holder Kit SIGMA 330 Options 6 3 AVA KONTRON MEDICAL 6 2 List of Probes Reference No Probe Type Convex Linear Probes 471 933 3 5 MHz CV 484 385 3 5 MHz MC 485 497 6 5 MHz MC Linear Probes 484 474 5 0 MHz LV 474 460 7 5 MHz LV 483 656 7 5MHz LVS Endocavitarian Probes 469 017 6 5 MHz EV 469 025 6 5 MHz MR 479 101 6 5 MHz VMC Mechanical Sector Probes 469 041 3 5 MHz GP 469 068 5 0 MHz GP 469 076 7 5 MHz GP 469 033 14 MHz PV Doppler Pencil Probes 478 733 2 0 MHz PEN 468 517 4 0 MHz PEN 468525 8 0 MHz PEN 468 509 6 4 2 0 MHz TCD Table 6 3 List of Probes SIGMA 110 SIGMA 330 6 3 Accessories Reference No Designation 100 250 250 bottle of ultrasound gel 469 122 Alkaline Battery 1 5 V for Remote control 477 729 Memory card PCMCIA SRAM 4 M 480 266 Memory card PCMCIA SRAM 8 M 48
243. is frozen Use the function keys to select the desired measurement Use the trackball to move the cursor to the desired position Press SET key upper left trackball key The value is automatically displayed on the screen example velocity or the second cursor appears for the measurement which needs several cursors example distance area etc Press SET key upper left trackball key to perform one more measurement of same type or press a menu key to make another measurement Select Undo in the measurement menu to erase the most recent measure Press FREEZE key or MEASUREMENT key to quit Measurement Mode 3 14 3 2D Measurement If you press on MEASUREMENT key SIGMA 110 330 displays the following menu a in 2D mode D pO dele a In dual 2D and Quad 2D 3 68 Distance Area Ellipse Angle EX SIGMA 110 SIGMA 330 10 12 01 H 4 KONTRON MEDICAL a in 2D SP pence Area Ellipse Angle Ratio Undo Note Distance is automatically selected when entering Measurement mode 3 14 3 1 Measuring a Distance Technical Data BS L LOL bebe 1 Press F1 Distance to select distance measurement Distance is automatically selected when entering Measurement mode 2 Usethe trackball to move the first marker to the desired position 3 Press upper left SET key to fix the marker the second end marker is now available 4 Use the trackball to move the second marker to
244. is plugged in the SIGMA the fol lowing message is displayed LIEN Please insert a disk into drive G When a flashcard is plugged its content is displayed as shown below 3 100 SIGMA 110 SIGMA 330 10 12 01 3 Removable Disk File Edit View Favorites Tools Help Back L3 Folders History As UI X Address 2 Modified IMAGED2 PCX fa IMAGEO3 PCX s IMAGEO4 PCX s IMAGEOS PCX IMAGEO6 PCX s IMAGEO7 PCX 3 IMAGEOS PCX Es IMAGEO9 PCX s IMAGE10 PCX IMAGE11 PCX s IMAGE12 PCX IMAGE13 PCX s IMAGE14 PCX s IMAGE15 PCX 3 IMAGE16 PCX IMAGE17 PCX s IMAGE18 PCX IMAGE19 PCX s IMAGE20 PCX s IMAGE21 PCX s IMAGE22 PCX s IMAGE23 PCX 3 IMAGE24 PCX s 25 IMAGE26 PCX IMAGE27 PCX s IMAGE28 PCX s IMAGE29 PCX 75 KB 78 KB 115 KB 108 KB 79 KB 98 141 156 KB 144 KB 156 KB 139 KB 130 KB 104 KB 101 KB 123 KB 132 KB 109 KB 129 KB 130 KB 84 KB 87 KB 133 KB 124 KB 134 KB 149 KB 132 KB 110 KB 109 KB 94 KB PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PCX Image Document PC
245. ise the electrical safety of the system KONTRON MEDICAL provides a medical grade isolating transformer and isolating accesso ries on request see Chapter 6 3 Accessories on page 6 5 for ordering 15 10 01 GENERAL INFORMATION xix Never connect Network RJ 45 directly to the system use a medical grade network isolator which must comply with IEC 601 1 specifications Wrong connections may compromise the electrical safety of the system KONTRON MEDICAL provides a medical grade isolator on request see Chapter 6 3 Acces sories on page 6 5 for ordering CAUTIONS In order to prevent an overheating ensure that the ventilation openings are not covered and keep the SIGMA 110 330 rear panel away from a vertical wall To prevent further damage to your system and the accessories power off the unit if it does not start up correctly Never expose the probes to gas heat or unauthorized liquid sterilization procedures see probe cleaning instructions These methods can permanently damage the probe Do not connect or disconnect an active probe during live scanning the system must be in freeze mode or turned off to connect or disconnect a probe Carefully follow the Operator s Manual instructions to clean or disinfect a probe Safety Symbols The International Electrotechnical Commission IEC has defined a set of graphic symbols for use on medical electronic equipment The following symbols are used on KONTRON MEDICAL systems
246. isplayed Warning 18 Internal temperature too high Change air filters as soon as possible ox It is displayed each 5 minutes until the internal temperature returns to a acceptable temperature below 65 C This message is also displayed at system power up if the internal temperature is too high 65 C or more 5 4 4 10 Warning 19 Time renting usage has expired The following message is displayed when the usage duration has expired the system is locked until the user contacts the sales service to buy new hours Warning 19 There is no more time left in your time renting contract Please contact your sales service ox 5 4 4 11 Warning 20 Internal temperature too low for mechanical transducers To prevent damages on mechanical transducer this warning is displayed if internal temperature is too low below 16 C Warning 20 Internal temperature too low Mechanical transducers can be damaged if used at low temperature Note the system temperature is displayed the System Info gt Boards window 15 10 01 TROUBLESHOOTING 5 15 5 4 4 12 Warning 21 File is too long This warning is displayed when the image file to save on the flashcard is too long greater than 192 kB Warning 21 File is too long Cannot store the image ox 5 4 4 13 Warning 22 Not enough place on SRAM This warning is displayed when there is no more room on the flashcard to save a file image report save
247. ists Enter a new name lox 15 10 01 TROUBLESHOOTING 5 13 AVA KONTRON MEDICAL 5 4 45 Warning 14 EasyPrint option is no more available This message is displayed when the EasyPrint option has been temporary set with a service dongle and is no more available This message is displayed after the start up Warning 14 EasyPrint option This option is no more available The date of validity has expired 5 4 4 6 Warning 15 This message is displayed when anyone tries to change the date of any not for sale version checksum to test software data integrity has been implemented to prevent hazardous modifica tions Warning 15 The date of the version is not valid 5 4 4 7 Warning 16 Invalid time renting key This message is displayed when an invalid time renting key is entered Warning 16 Invalid time renting key Time renting key is invalid no new time will be activated ox 5 4 4 8 Warning 17 Invalid time or date At start up the system check the date and the time If one of both is invalid then this message is displayed to indicate that the date and time must be updated 5 14 SIGMA 110 SIGMA 330 15 10 01 Warning 17 Invalid Time or Date Time or Date must be updated 5 4 4 9 Warning 18 Internal temperature too high Periodically the system checks for its internal temperature If a too high temperature is measured for a long period the following message will be d
248. k rarefactional pressure amplitude at a specified point Pulse Intensity Integral The Pulse Intensity Integral PII is time integral of instantaneous velocity for any specific point and for any specific pulse integrated over the time in which the envelope of acoustic pressure or the envelope of hydrophone signal for the specific pulse is non zero It is equal to the energy flu ence per pulse 15 10 01 GENERAL INFORMATION Xxix H 4 KONTRON MEDICAL IV Compliance with Standards SIGMA 110 and SIGMA 330 systems manufactured by KONTRON MEDICAL entirely comply with the Council Directive 93 42 EEC of 14 June 1993 concerning medical devices and bear the CE Mark They are in compliance with CE MDD mark German regulation EC 601 1 Class 1 Type B Electrical Safety EC 1157 Acoustic power reporting FDA 510 k Consequently all OEM equipment video recorders external TV monitors and other peripherals should be connected to the three isolated outputs provided by SIGMA 330 Expert or Excellence cart or to wall outlets using the proper isolator see Chapter 6 3 Accessories on page 6 5 for ordering marked with CE identification mark and be in compliance with IEC 950 or IEC 601 1 Stand ards XXX SIGMA 110 SIGMA 330 15 10 01 15 10 01 1 INSTRUMENT DESCRIPTION INSTRUMENT DESCRIPTION SIGMA 110 SIGMA 330 15 10 01 1 1 Introduction SIGMA 110 and SIGMA 330 are Ultrasound Diagnostic
249. kers Remote control receiver Location dedicated to Remote Control Unit Remote Control Unit is optional with SIGMA 110 Video screen Receptacle for bottle of gel Probe holder 10 Keyboard 9 X Gr C Figure 1 6 SIGMA 110 Light SIGMA 110 Master and SIGMA 330 Master front view 15 10 01 INSTRUMENT DESCRIPTION 1 17 AVA KONTRON MEDICAL 1 3 4 2 SIGMA 330 Expert Front View The following items are shown in figure 1 8 SIGMA 330 Expert front view on page 1 19 Audio volume adjustment Brightness adjustment for video screen Contrast adjustment for video screen Loudspeakers Remote control receiver Remote Control Unit Keyboard Cabinet for optional Video Printer Cabinet for optional Video Cassette Recorder 10 Cabinet for accessories 11 Control pedal for carrying up down the column 12 Video screen colour monitor ON spe O o Figure 1 7 SIGMA 330 Expert front view closed 1 18 SIGMA 110 SIGMA 330 15 10 01 Figure 1 8 SIGMA 330 Expert front view 15 10 01 INSTRUMENT DESCRIPTION 1 19 AVA KONTRON MEDICAL 1 3 43 SIGMA 330 Excellence Front View The following items are shown in figure 1 9 SIGMA 330 Excellence front view on page 1 21 1 Additional high resolution flat screen 2 Compact personal computer integrated in the lower cabinet 1 20 SIGMA 110 SIGMA 330 15 10 01 15 10 01 Figure 1 9 SIGMA 330 Excellence front view INSTRUMENT DESCRIPTION 1 21
250. key and using the trackball to select the images In dual image formats such as 2D TM 2D PW use the SELECT key to switch between the two cine modes 3 9 1 Storing Pictures The system is continuously recording ultrasound images in memory Press FREEZE key to stop the recording The last images are stored in the SIGMA 110 330 memory The latest is displayed on the video screen The displayed image number is shown at the bottom right of the video screen Note By pressing the FREEZE key again the previous stored images are overwritten A new recording is started 3 48 SIGMA 110 SIGMA 330 10 12 01 3 9 2 Displaying Pictures The user can analyse the images previously recorded The trackball is used to perform either for ward or backward review The displayed image number is shown at the bottom right of the video screen 3 9 3 Cine Auto Replay For each 2D and CFM frozen menu Cine key is displayed Pressing the Cine key displays the Cine Menu that allows the user to easily manage the cine replay De pe pep opes LL EL Ee a gt play in the defined limits using the selected frame rate stop the current cine sequence Note that when the cine is played the cine frame counter is hidden The corresponding menu key is a two states key the default action is play Note that the icon representing the next action is always displayed So when the cine is played the stop icon is displayed and vice versa a py play the cine step by
251. layed xxx study bc study zzz study mE 0 00 0 00 0 00 000 0 Freeze 090 aersudy yyx study 0 0 00 000 Report pe 0 27 000 anes 0 00 MS study fgt study D 0 49 Report n ES E mu M A 2 Exiting the Biometry There are several means to exit the biometry e using the REPORT key the user returns to the frozen image molde mm 2000 00 port A N N 0 00 x study fgt study NE 0 00 00 0 U E FROZEN using the lt ESCAPE gt key is the same as using the lt REPORT gt key using the lt FREEZE gt key the user returns to a live image using the MEASUREMENTS key the user returns to a frozen image with the measure ment menu active using the lt ANNOTATION gt key the user returns to a frozen image with the annotation menu active using the PROBE key the user returns to a frozen image with the probe menu active using the MAGNIFY key the user returns to a frozen magnified image when the cur rent mode is the single 2D A 3 Make a Measurement from Report The represents the cursor used to select an object measurement field or information field This arrow can be moved with the trackball
252. le K 2 2 Mitral Valve page K 2 2 1 2D measures Description Sono Win Card 2D LV Simpson s Rule Chapter Mitral Valve Diameter DIAM mm Card D Mitral Value Mitral Valve Area VA1 Card D Mitral Value K 2 2 2 TM measures Description Sono Win Chapter Slope between E and F waves EFSLP mm s Card M MV and Aorta Distance from E wave to septum K 2 2 3 SP measures EIVS d mm Card M MV and Aorta Description Sono Win Chapter Velocity Time Integral VTI Card D Mitral Valve VTI Peak Velocity Vpeak calc Card D Mitral Valve VTI Peak Gradient PkG mmHg peakPG mmHg Card D Mitral Valve VTI Mean Gradient MnG mmHg meanPG mmHg Card D Mitral Valve Peak Velocity for the E wave PkVE m s E VEL m s Card D Mitral Valve Peak Velocity for the A wave PkVA m s A VEL m s Card D Mitral Valve IsoVolumetric Relaxation Time IVRT IRT ms Card D Mitral Valve 5 Peak Card D Mitral Valve Stroke Volume SV ml SV ml Card D Mitral Valve Stroke Volume Index Sl m2 Sl ml m2 Card D Mitral Valve Cardiac Output l min CO l min Card D Mitral Valve Cardiac Output Index CI l min m2 CI l min m2 Card D Mitral Valve K 2 2 4 Heart rate TM or SP measurement Description Sono Win Chapter Patient heart rate in beats per Card D Mitral Valve minutes on mitral valve 1
253. ler Mode AVAILABLE MODES Steerable PW Steerable CW SIGNAL PROCESSING Multi frequency Doppler mode 2 3 4 and 8 MHz probe dependent Velocity range PW 1 kHz to 10 kHz CW 1 kHz to 20 kHz 10 cm sec to 3 5 m s PW 7 2 m sec CW full scale depending on probe and operating frequency High pass wall filter 10 cut off frequencies adjustable between 50 to 1000 Hz Grey scale optimization with 8 post processing curves probe dependent Spectrum gain control 11 selections between 0 and 30 dB 120 dB dynamic range for best sensitivity 256 point FFT computing time of 0 2 ms Doppler transmit power control 8 selections between 0 dB and 21 dB Doppler angle correction from 80 to 80 Scrolling speed 2 3 5 8 sec screen full screen e 1 1 5 2 5 4 sec screen 2D SP Adjustable audio volume PW GATE PW gate adjustable for sample volumes between 1 and 15 mm 8 selections PW gate adjustable with the trackball between 0 and maxi depth of the image format DISPLAY 2D 50 screen Doppler 50 screen 2D icon Doppler 15 10 01 INSTRUMENT DESCRIPTION 1 47 Base line shift 9 positions for optimal signal display avoiding spectrum aliasing e Vuean real time trace display e VMAx and Vmax real time trace display Quasi duplex automatic refresh 4 levels according to scrolling speed IMAGE MEMORY Cine Mode up to 16 trace screens in full Doppler up to 5
254. level III 1 7 8 USB Link Digital transfer of images and report text files to Personal Computer through USB cable Compatibility refer to Chapter 3 18 2 Compatibility on page 3 99 1 7 9 Peripherals Optional The following peripherals can be connected to the system VCR VHS and S VHS B W video printer Parallel DeskJet printer PC compatible for images EasyPrint M and report printout e B W monitor 1 7 10 Inputs Outputs e S VHS VHS including audio input output for VCR connection PAL NTSC compatible video playback automatically fed to the monitor Black amp White video composite output for B W video printer connection Double footswitch Freeze Print Select image Memory card connector PCMCIA dedicated to software upgrade user setup storage and digital archiving KIPRISM RGB video output for external monitor and color video printer Parallel port for images and report printout Serial port for peripheral devices USB port for data transfer to PC 1 7 11 Measurement CALIPERS Trackball controls the multiple callipers Complete measurement capabilities on frozen images 2D distance surface and circumference of area surface and circumference of ellipse angle distance and area ratio TM distance time slope heart rate distance and time ratio LV studies PW CW speed gradient frequency time acceleration integral amp RI heart rate speed gradien
255. low Pulsed Wave Doppler to detect functional abnormalities 15 10 01 GENERAL INFORMATION xvii 4 KONTRON MEDICAL WARNING This system is not to be used for transorbital or any other ophtalmic applica tions The main features of the probes are shown in the table below Scanning i Resolution Ceramics Angle Width i Lx W degree mm mm Convex 3 5 MHz CV 45 60 70 1 86 4 x 12 3 5 MHz MC 30 90 70 i 38 2 x 11 6 5 MHz MC 30 90 45 33 4 x 6 5 5 0 MHz LV 63 50 86 4 x 11 7 5 MHz LV 50 20 59 4 x 4 5 7 5 MHz LVS 38 25 38 4 x 6 5 Endocavitarian 6 5 MHz EV 25 6 5 MHz 25 8 6 5 2 45 33 4 x 6 5 Annular Sector 3 5 MHz GP 2 5 70 5 0 MHz GP 3 7 40 7 5 MHz GP 5 1 20 14 MHz PV 15 TCD 2 MHZ 45 PEN 2 MHz 45 PEN 4 MHz 30 PEN 8 MHz 20 Table ii Probe Features Ill 2 Safety Information In this manual a WARNING pertains to possible injury to a patient and or the sonographer A CAUTION describes the precaution which are necessary to protect the equipment Be sure that you understand and observe each of cautions and warnings xviii SIGMA 110 SIGMA 330 15 10 01 1 2 1 Electrical Safety As defined in EN60601 1 IEC Standard 601 1 safety of Medical Electrical Equipment this equipment is classified as Class I type probes while the ECG
256. ludes an ECG signal amplifier for displaying the trace on the video screen and a QRS detector for synchronizing the 2D image ECG is activated for Cardio Setups enabling is probe setup dependent It is disabled by default for other applications To enable ECG Press SETUP key on the keyboard Press Prefs in the Setup Menu Press Display in the Preferences Menu 4 Press ECG ON in the Display Menu Heart Rate HR in b min is automatically calculated by the system average on 5 QRS periods when the QRS waveform appears on the screen and displayed at the bottom right of the screen The ECG Module can provide four error messages NO ECG LEAD OFF ECG ERROR and BAD ELECTRODE These messages are displayed in red in the place of Heart Rate when they occur N gt NO ECG ECG not connected or connected wrongly LEAD OFF clamps are defective or not correctly placed on the patient BAD ELECTRODE clamps are defective or not connected ECG ERROR when a failure happens in the ECG software module Freeze then unfreeze the system to work out the problem The Trigger mode allows the synchronization of 2D image The softkey Trigger Off 1 1 2 is used to disable enable one or two triggers The ECG On Off preference can be selected for each probe and saved in each probe setup 10 12 01 OPERATING INSTRUCTIONS 3 95 H 4 KONTRON MEDICAL 3 17 Options These options are a EasyPrint B
257. lume Index in millilitres per square meters gt CO Cardiac Output in litres per minute gt Cardiac Output Index in litres minute per square meters 7 22 SIGMA 110 SIGMA 330 15 10 01 H 4 KONTRON HINXMEDICAL c TM study AoD End diastolic Aortic Root diameter in cm LAD Left Atrial end systolic diameter in cm AVO Aortic Valve Opening in cm LVET Left Ventricle Ejection Time in second LVPEP Left Ventricle Pre Ejection Period in second LAD AoD Ratio Left Atrial Aortic Root Diameter gt LVPEP LVET Ratio Pre Ejection Period Ejection Time d Effective Opening Area Aortic Valve LVOTD Left Ventricle Output Trunk Diameter in cm Area 2 computed from Divot Vivot Velocity at Left Ventricle Output Trunk in meters per second Vao Velocity at Aortic Valve in meters per second VTIIvot Velocity Time Integral at Left Ventricle Output Trunk in cm VTI Velocity Time Integral at Aortic Valve in cm gt EOA Effective Opening Area of the Aortic Valve in cm2 This area can be com puted from VTIIvot and VTlao or from Vao and Vlvot D 3 2 1 Ventricle Output Trunk a 2D study LVOTD LVOT Diameter in cm LVOTA LVOT Area in cm2 b SP study VTI Velocity Time Integral in cm PkV Peak Velocity in m s PkG Peak Gradient in mmHg MnG Mean Gradient in mmHg gt SV Stroke Volume in millilitres gt 5 Stroke Volume Index in millilitres per square meters gt
258. ly needs to press the associated function key to activate the action Selectable menu items with toggle action Toggle menu items have a different behaviour the menu item string changes dynamically and describes the next action to be performed when the button is pressed and not the state of the system For instance Up Down image inversion in 2D mode is controlled by the 2D Inv menu item as fol lows 3 8 SIGMA 110 SIGMA 330 10 12 01 Angle Dual Zoom Freq Biopsy N 20 Inv Right Tilt 5 CN 5 Ange Dual Zoom Freq Biopsy AN 20 Inv Right Tilt moo 5 Convention Throughout this document toggle menu items contain the symbol such as Left Right but note that only Up or Down will be displayed at a given time 3 4 5 2 Incremental Menu Items Incremental menu items are associated with the adjustment of a parameter The user presses the associated function key to select the item and eventually adjusts increments or decrements the parameter using the incremental potentiometer Turn the button clockwise to increase the parameter value and counter clockwise to decrease it when the minimum or maximum value is reached a beep warns the user For example to change the angle of 2D sector 1 Select the Angle F1 function key 2 Turn MP left or right to decrease increase the scanning angle 10 12 01 OPERATING INSTRUCTIO
259. ly on Doppler spectrum Note The automatic integral or PI RI calculations are based on Vmax trace They can be selected even though Vmax trace is not displayed MVI is based on Vmean trace a Rainbow SIGMA 330 only This function controls the colorisation of spectrum image The MP softpot allows the selec tion of 8 sets of colour Rainbow 0 to Rainb 7 The selected one is shown in the technical data area on the right side of the screen Rainbow 0 corresponds to black and white image display Rainbow 1 to 7 corresponds to colorised spectrum a TIMI Display Hide Thermal or Mechanical Indexes 3 7 3 3 PW Frozen Menu ese Store Angle 10 12 01 OPERATING INSTRUCTIONS 3 37 H 4 KONTRON MEDICAL See section PW live menu above for details of items See 2D frozen menu in Chapter 3 7 1 3 2D Frozen Menu on page 3 30 3 7 3 4 PW Doppler Audio Amplifier SIGMA 330 and SIGMA 110 include a stereo amplifier with associated loudspeakers to amplify Doppler audio signal Volume is adjustable by rotating the uppermost knob on the left side on the front of the monitor housing 3 38 SIGMA 110 SIGMA 330 10 12 01 3 7 4 CW Doppler SIGMA 110 and SIGMA 330 perform Continuous Wave Doppler CW when Doppler option is installed Not all of the transducers are CW compatible See table i Probe applications on page xvi for the CW compatible probes 1 The first time that you press the CW key
260. m axial distance for measurements break point depth 1 69 sqrt Agort for MI axial distance of maximum lt for axial distance of maximum 6 2 3 equivalent beam diameter at axial distance Z 4 4 2 4 Wo 1 2 where 2 is the temporal average intensity as a function of z center frequency 105 SIGMA 110 SIGMA 330 15 10 01 Dim of Agort PD PRF p PI max deq Pllmax FL Ip 3 MI max 15 10 01 4 MEDICAL active aperture dimensions for the azimuthal x and elevational planes pulse duration pulse repetition frequency peak rarefactional pressure where the spatial peak pulse intensity integral is maximum equivalent beam diameter at the point where the spatial peak pulse intensity integral is maximum focal length derated pulse average intensity at the point of maximum MI APPENDICES 7 115 H 4 KONTRON HAN MEDICAL M 3 Acoustic Output Tables The following tables show the detailed measurement results for transducer mode combinations which have a maximum thermal and or mechanical index exceeding a value of 1 0 Transducer Model 3 5MHz GP Operating Mode PW mode TIS TIB TIC Index Label scan Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value a 10 23 Pr3 MPa E Wo mW 5 96 7 m
261. m s Veld Velocity at Diastole in m s Mean Velocity m s Resistance Index Pulsatility Index Vels Veld Ratio Velocity Systole Diastole The resistance index can be either deduced from the PI calculation or computed separately Since it can be computed separately some parameters are duplicated F2 3 Equation Time Average Maximum Velocity in metres per second TAMX D Time VTI Velocity Time Integral Time Duration flow in seconds Resistance Index from Pourcelot RI Vels Veld RED 22 Vels Vels Velocity at systole m s Veld Velocity at diastole in m s Pulsatility Index PID Vels Veld TAMX Vels Velocity at systole m s Veld Velocity at diastole in m s TAMX Time Average Maximum Velocity in m s 7 42 SIGMA 110 SIGMA 330 15 10 01 H 4 KONTRON HINMEDICAL F 3 Foetal Information Sheet To access this page the user must select the L icon from one of the previous screens If the user selects the 2 icon from the fetal information sheet the 2D or SP TM sheet will be displayed again according to the current mode 2D 14 02 01 08 30 31 GRAVIDITAS PARA Term Prema Abortion Living FETAL DESCRIPTION GENDER seers FETAL MOVEMENT FETAL BREATHING 4 CARDIAC ACTIVITY
262. me SMITE ndeine corresponding menu 5 dis Phone number D played select the FILES 5 SMITHOS PCX 19 11 97 10 02 06 SMITHO06 PCX 19 11 97 10 02 54 STENOSO7 PCX 19 11 97 10 04 41 SMITHO8 PCX 19 11 97 10 05 35 Patient Archive mode press on MENU PREVI OUS the screen is changed SMITHO3 TXT 19 11 97 10 01 12 as shown below a popup list containing all the patients present the flashcard is displayed on the Delete Del All right and the information for Patient gt the selected patient is dis played on the left a The third menu key is used to delete a Patient ALL information relative to a patient When the user presses it a dialogue box for confirmation is then displayed Do you really want to delete all data for patient SMITH Deletion cannot be undone Yes No a The 4th menu key is used to delete all data for all patients stored on the flashcard When the user presses it a dialogue box appears for a confirmation Do you really want to delete all data for all patients Deletion cannot be undone Yes No With Yes the SRAM is for matted 10 12 01 OPERATING INSTRUCTIONS 3 57 AVA KONTRON MEDICAL 3 11 4 7 Battery State When the user plugs a SRAM with a low state battery a warning message is displayed to inform the user If this message appears the user should change the battery The operation is described by the SRAM man
263. ml SV Card 2D LV Single Plane Stroke Index ml Sl ml m2 Card 2D LV Single Plane Cardiac Output l min CO l min Card 2D LV Single Plane Cardiac Index l min m2 CI l min m2 Card 2D LV Single Plane 15 10 01 APPENDICES 7 95 M 4 KONTRON ICAL K 2 1 2 2D measures Simpson K 2 1 3 TM measures Teichholtz Description Sono Win Chapter Short Axis Area 1 at Diastole Short Axis Area 2 at Diastole cm2 LVAMD Card 2D Biplane Card 2D LV Simpson s Rule Long Axis Length at Diastole Short Axis Area 1 at Systole cm cm2 Card 2D LV Simpson s Rule Card 2D LV Biplane Short Axis Area 2 at Systole Long Axis Length at Systole cm2 cm Card 2D LV Simpson s Rule Card 2D LV Simpson s Rule Diastolic Volume Systolic Volume cm3 cm3 Card 2D Biplane Card 2D LV Biplane Ejection Fraction Cardiac Output l min l min Card 2D LV Biplane Card 2D LV Simpson s Rule Cardiac Index Stroke Volume SV 2 SV 2 ml Card 2D LV Simpson s Rule Card 2D LV Biplane Stroke Index Sl ml m2 SI ml m2 Card 2D LV Biplane 7 96 Description SIGMA Sono Win Chapter Right Ventricle Diameter at diastole RVDd cm RVDD mm Card M LV Teichholtz Inter Ventricular Septal IVSTS
264. ml m2 CI2 ml m2 Angio Flow Volume VTI Cardiac Output l min CO1 l min Cardiac Output Index K 3 7 Frequency Description 2 CI1 l min m2 Sono Win Angio Flow Volume VTI Angio Flow Volume VTI Chapter Doppler frequency shift K 3 8 Heart rate SP or TM measurement Description Sono Win Angio Flow Volume VTI Chapter Measured Heart rate K 3 9 Continuity Equations Description Sono Win Angio Flow Volume VTI Chapter Diameter 1 Diam Angio Doppler Auto Trace Area 1 AREA1 Angio Doppler Auto Trace Velocity 1 VpeakS1 Angio Doppler Auto Trace Velocity 2 VpeakS2 Angio Doppler Auto Trace Area 2 with the Velocity AREA1 Angio Flow Volume Velocity Time Integral 1 VTI1 Angio Flow Volume VTI Velocity Time Integral 2 VTI2 Angio Flow Volume VTI Area 2 with the Velocity Time Integral K 3 10 Resistance Index Pulsatility Index Description SIGMA AREA2 Sono Win Angio Flow Volume VTI Chapter Pulsatility Index PI Doppler Auto Trace Mean Velocity TAMX Vmean P1 m s Angio Doppler Auto Trace Velocity at Systole Vels VpeakS1 Angio Doppler Auto Trace Velocity at Diastole Veld VED1 Angio Doppler Auto Trace
265. mm Card M LV Teichholtz diastole Left Ventricle Diameter at diastole LVDd cm LVIDD mm Card M LV Teichholtz DM Len ventriculaf LVPWD mm Card M LV Teichholtz Inter Ventricular Septal Thickness at IVSs ni IVSTS a Card M LV Teichholtz systole Left Ventricle Diameter at systole LVDs cm LVIDS mm Card M LV Teichholtz Posterior Left Ventricular Wall at systole PLVWs cm LVPWS mm Card M LV Teichholtz Left Ventricle Ejection Time LVET sec ET ms Card M LV Teichholtz Diastolic Volume Teichholz formula VOLd cm3 EDV ml Card M LV Teichholtz Systolic Volume Teichholz formula VOLs cm3 ESV ml Card M LV Teichholtz Shortening Fraction SF 96 FS Card M LV Teichholtz Left Ventricle Mass LVM gr LV mass g Card M LV Teichholtz Left Ventricle Mass Index LVMI gr m2 LV massi g m2 Card M LV Teichholtz Eod of Gireumierential Fibre Short VCF circ sec MVCF circ s Card Teichholtz Ejection Fraction EF EF Card M LV Teichholtz Stroke Volume SV ml SV ml Card M LV Teichholtz Stroke Volume Index Sl ml m2 Sl ml m2 Card M LV Teichholtz Cardiac Output CO l min CO l min Card M LV Teichholtz Cardiac Output Index CI l min m2 CI l min m2 Card M LV Teichholtz Ratio Left Ventricular Wall diastole on LVPWD Left Ventricle Radius diastole Hun LVIDD RISE SIGMA 110 SIGMA 330 15 10 01 K 2 1 4 Heart rate SP measurement Description Sono Win Chapter Heart rate measured on Left Ventric
266. most of the cart components plastic are also recyclable The SIGMA 110 and SIGMA 330 contains electronic boards batteries and tubes Before you dis pose the system these boards batteries and tubes must be removed and discarded according to local regulations or recycled where facilities exist Contact your local KONTRON MEDICAL company or agent for further informations For battery disposal contact your local waste disposal facility 15 10 01 GENERAL INFORMATION xxi AVA KONTRON MEDICAL 11 2 3 Biocompatbility and Infection Control Items in contact with patient The probe and electrode materials that are in contact with patients comply with the European applicable requirements EN10993 No negative reactions to these materials have been reported Note KONTRON probes and electrodes do NOT contain Latex Infection Control Since probes and electrodes are intended to be used on intact skin the use of this system has a very limited probability of being able to propagate infections basic procedures as described later in this manual are sufficient for infection control 11 2 4 Ultrasound Safety Introduction KONTRON MEDICAL has adopted the more recent requirements and recommendations estab lished by the USA Food and Drug Administration and by the American Institute for Ultrasound in Medicine The SIGMA 110 330 therefore equipped with the Acoustic Output Display feature to provide the user with real time on line inform
267. mote control Unit Cyrillic according to system language 524 204 Fuse 5x 20mm T2A 717 150 Fuse 5 x 20 mm T 4 A according to line voltage 528 129 Fuse 5 x 20 mm T 6 3 503 126 Fuse 5 x 20 mm T 8 A according to line voltage 481 033 Remote control cable for Video printer 862 169 Coaxial cable 75 BNC BNC L 2 m 481 076 VCR cable 481 068 Footswitch 487 082 Integrated PC without frame grabber board 487 0820E Integrated PC with frame grabber board 487 341 External PC Monitor 487 163 USB cable A BM M 15 Pts L 1 8 485 519 SIGMA ORION VIDEO Cable 487 376 PC Keyboard QWERTY 86 Keys 487 309 Keyboard Label CTRL ALT ALTGR b C 487 368 Keyboard Label CAPS DEL b6 487 724 Allen key 6 P 410 713 CEE22 socket male 2x10A 471 059 Air filter 426 016 Quality Control form Table 2 2 Supplying list for SIGMA330 Expert and SIGMA 330 Excellence when CFM option is installed on SIGMA 330 systems for SIGMA 330 Excellence without frame grabber board for SIGMA 330 Excellence with frame grabber board when USB Link option is installed PNI Ol O DI D sss ss ot 10 12 01 INSTALLATION 2 5 2 5 Transport For transport SIGMA 110 and SIGMA 330 equipments must be placed in their original package provid
268. n Angio Flow Volume VTI Chapter Distance 1 Tumor4 L mm Small Parts Mamma Distance 2 Tumor4 mm Small Parts Mamma Distance 3 Tumor4 W Small Parts Mamma Angio Volume K 3 4 Volume flow Tumor4 V Small Parts Mamma Description SIGMA Sono Win Chapter Mean Velocity Integral MVI cm VTI2 m Angio Flow Volume VTI Time Average Velocity TAV m s Vmean1 m s Angio Flow Volume VTI Diameter of the vessel Diam cm Diam mm Angio Flow Volume VTI Blood Flow BF mn FVOL1 l min Angio Doppler Auto Trace K 3 5 Description Spectral Broadening Index Sono Win Chapter Velocity Time Integral VTI2 m Angio Flow Volume VTI Time Average Maximum Velocity Mean Velocity MV2 Angio Doppler Auto Trace Peak Velocity MV1 Angio Doppler Auto Trace Mean Velocity Integral VTI1 Angio Flow Volume VTI Time Average Velocity Vmean2 Angio Flow Volume VTI Spectral Broadening Index 7 102 SBI SIGMA 110 SIGMA 330 Angio Flow Volume VTI 15 10 01 K 3 6 Cardiac Output Description Sono Win Chapter Velocity Time Integral cm VTI1 m Angio Flow Volume VTI Diameter of the vessel cm Diam mm Angio Doppler Auto Trace Stroke Volume ml SV2 ml Angio Flow Volume VTI Stroke Volume Index
269. n first out a Escape Key The ESCape key ESC can be used to abort the current measurement When using this key the system returns to the measurement menu a Backspace Key The Backspace key lt in the alphanumeric keypad be used to erase the last point for example when tracing an area contour 3 14 1 5 Result Display Measurement results are displayed on the right side of the screen just under the technical data Ten result lines could be displayed at the same time The results are displayed from the top to the bottom Each displayed result contains the order number of the result the type the value and the unit 10 12 01 OPERATING INSTRUCTIONS 3 67 AVA KONTRON M DICAL 3 14 1 6 Including Measurement in Biometry Study When a measurement has been made in the measurement mode the result can be integrated in the biometry study For this press REPORT key the current biometry page is displayed then select the desired field by moving the cursor with the trackball and valid with SET key Note The report must be entered from measurement mode to allow inclusion 3 14 1 7 Formulas of the Displayed Measurements For details about the formulas which stand behind the displayed measurement see Chapter 7 APPENDICES on page 7 1 3 14 2 Starting a Measurement Ti e 6 7 Press MEASUREMENT key to enter Measurement Mode measurement menu is displayed on the screen and the ultrasound image
270. n these two points is computed according to the current image format depth for the distance and scrolling speed for the time and is displayed in cm s on the right side of the screen 3 14 5 4 Heart Rate Technical Data Distanco Time Slope Heart Rate pos Ratio Undo The TM Heart Rate measurement is made by setting two lines on the image start and end line The heart rate and the time between these two lines is computed according to the current scroll ing speed and is displayed in seconds for the time and in beats per minute for the heart rate on the right side of the screen 10 12 01 OPERATING INSTRUCTIONS 3 79 AVA KONTRON MEDICAL 3 14 5 5 Left Ventricular Study The Left Ventricle Study can be computed as a full measurement or as an abbreviated measure ment So two different entries are implemented in the TM measurement menu Fu LVSt Full Left Ventricle Study EN T 2x ub PA 75 lt 1 1 en 8141 v 6wm slv So SR GA 6 51 6SKl 8 6W 6871 E P 6W 177 lt 883 pistance Time Slope near V abivst Ratio Undo e 54 Inter Ventricular Septal Thickness diastole cm LDd Left Ventricle Diameter diastole cm PWd Posterior Left Ventricular Wall diastole cm 55 Inter Ventricular Septal Thickness systole cm 105 Left Ventri
271. n cm3 VOLs 8 LAAs VOL lt LALS LAAs Long Axis Area at systole in cm2 LALs Long Axis Length at systole in cm Ejection Fraction in percent EF EF D VOLd VOLs VOLd MM VOLd End diastolic Volume in cm3 VOLs End systolic Volume in cm3 Stroke Volume in millilitres SV Sv DvoLd VOLs VOLd End diastolic Volume in cm3 VOLs End systolic Volume in cm3 e Stroke Volume Index in square meters SI SV 1 22 SV Stroke Volume in millilitres BSA Body Surface Area in m2 Cardiac Output in litres per minute CO co DSV HR SV HR 1000 SV Stroke Volume in millilitres HR Heart Rate in beats per minute 7 14 SIGMA 110 SIGMA 330 15 10 01 H 4 KONTRON HINXMEDICAL Cardiac Output Index in litres per minute per square meters CO CO Cardiac Output in litres per minute BSA Body Surface Area in m2 b TM study e End Diastolic Volume cm3 with Teichholz VOL d D 7 LVDd Dee 2 40 LVDd LVDd Left Ventricle Diameter diastole in cm e End Systolic Volume in cm3 with Teichholz VOLs D 7 LVDs Vols D 2 005 _ AES LVDs Left Ventricle Diameter systole in cm Shortening fraction in percentage SF SF p LVDs LVDd i LVDd Left Ventricle Diameter diastole in cm LVDs Left Ventricle Diameter systole in cm Left Ventricle Mass in grams LVM LVM D 1 04 VSdQLVDdQ PLY 13 6 IVSd Inter Ventricular Se
272. n layer of the keyboard and the trackball can be easily removed for cleaning they are washable To remove the grid press it as shown in figure 4 1 Keyboard Cleaning on page 4 3 and pull it forward Then the silicon layer and the trackball are accessible Figure 4 1 Keyboard Cleaning 10 12 01 MAINTENANCE 4 3 AVA KONTRON MEDICAL 4 1 5 instrument Clean the surface of the SIGMA 110 330 with a dry cloth If more extensive cleaning is required switch off the instrument and disconnect the power cord Use a slightly dampened soft cloth and very mild detergent solution to clean exterior surfaces Never use strong solvents slosh water on the instrument or immerse any part of the instrument in any liquid Never remove the protective covers of the SIGMA 110 330 Hazardous voltage levels exist If more extensive cleaning is required contact your Customer Service Representative 4 4 SIGMA 110 SIGMA 330 10 12 01 4 2 Disinfection It is recommended that all probes be cleaned adequately disinfected between patients All probes may be disinfected with Cidex 1 The recommended duration for disinfection is 10 minutes For detailed information on disinfection of probes and duration of disinfection refer to the probes manufacturer s recommendations For special applications and specific transducers refer to their proper Operating Manual The following figure shows the immersible part for the different probe types 3 5
273. nal peripherals directly to wall outlets use the outlet availa ble in the cart or a medical grade isolating transformer which must comply with IEC 601 1 specifications Wrong connections may compromise the electrical safety of the system KONTRON MEDICAL provides a medical grade isolating transformer on request see Chapter 6 3 KAccessoriesS on page 6 5 for ordering 10 12 01 OPERATING INSTRUCTIONS 3 115 3 116 This page is intentionally left blank SIGMA 110 SIGMA 330 10 12 01 10 12 01 4 MAINTENANCE 4 2 SIGMA 110 SIGMA 330 10 12 01 41 Cleaning 4 1 1 Probes It is recommended that all probes be cleaned adequately disinfected between patients Gently clean the probe with a very mild detergent solution and a slightly dampened cloth Do not apply pressure Never immerse the probe any liquid except for disinfection see Chapter 4 2 Disinfection on page 4 5 41 2 TV Monitor Caution TV Monitor screen includes an anti reflecting coating For cleaning spray anti static screen cleaner e g cleaning products for computer wiping with soft wiper 4 1 3 EYE Q 300M Monitor For cleaning monitor cover it is recommended to use Johnson Glass Clue it is possible to use Alkaline cleaner or IPA Isopropylalcool For cleaning monitor panel it is recommended to use Sanwa CD 41NT For cleaning monitor air filter any IPA can be used 4 1 4 Keyboard The top grid and the silico
274. nciples of Selection and Validation on page 3 53 PC Mode see Chapter 3 20 4 PC remote control features description on page 3 111 Some functions are linked to the trackball Magnify and Zoom moves zoomed or magnified area Annotation add text set position of cursor Annotation Arrow mark set arrow position on image Measures 15 10 01 INSTRUMENT DESCRIPTION 1 31 Patient menu Report The trackball is not attached to several functions simultaneously except in PW live mode The trackball is attached to the last selected function When the current function ends the track ball attachment returns to the previous one 1 4 41 Positioning of the Cursor In any imaging mode live and freeze the user can move a Position Cursor on the screen to point to a region of interest Press the lower key to display the cursor and move it using the trackball Press the lower key again to erase the cursor and return to previous function 1 32 SIGMA 110 SIGMA 330 15 10 01 1 5 Screen Layout 1 5 1 Ultrasound Screen Layout General information date amp time 8 Technical data 5 o 5 5 S 5 Meas result 7410 5 z t S rin Ed Con 4 d LAT OT ECG message j Pid Tilt Body icon Menu k
275. ndling advise Unplugging a transducer in live mode may generate some damages on the transducer or on the board so when the user unplugs the current transducer in live mode the following message is displayed and the system is frozen Warning 2 Transducer handling advise Please do not unplug transducers in live mode Thank you lox Remark this message can be displayed when the transducer cable is broken can not read the transducer code 5 4 2 System Configuration Check 5 4 2 1 Warning 3 Hardware board version During system start up a check of the different available boards revision software version dependant is made If one of the board VLCUS LA COL_DOP SP_DOP is not in the list of the current available board revision a warning message is displayed just after system start up to inform the user that one or more of the board should not be used with this software version Warning 3 invalid hardware detected Invalid LA board version 01 5 10 SIGMA 110 SIGMA 330 15 10 01 By pressing any key the dialogue box disappears This message is displayed at each system start up until the invalid board is modified or replaced by the service team 5 4 22 Warning 4 Invalid system configuration For each type of system a list of the available boards is defined At system start up the different boards are checked according to the current type if some boards are found that are normally not included in this
276. nical probes can not be used for CFM This key exists only on SIGMA 330 systems option CFM 15 10 01 INSTRUMENT DESCRIPTION 1 29 AVA KONTRON MEDICAL 1 4 2 6 PW Key The PW key sets the system in PW mode 1 4 2 7 CW Key The CW key sets the system in CW mode not all probes are CW compatible see table i Probe applications on page xvi 1 4 2 8 MAGNIFY Key The MAGNIFY key is used to display an ultrasound image area magnified by a factor 2 in live or freeze mode in 2D CFM mode 1 4 2 9 SELECT Key The SELECT key acts when 2 or more images are displayed on the screen It freezes current image pad if needed and sets in live mode the next one 1 4 2 10 GAIN Pots The GAIN pots change the gain of the current image 2D TM CFM PW or CW It has no action in freeze mode Out of the gain range limits the system emits a sound beep to warn the user The gain pot which is currently active is backlighted 1 4 2 11 TGC Pots The TGC Time Gain Control is achieved by 5 sliders rectilinear potentiometers Five zones are vertically defined on the image Each slider corresponds to one of the 5 zones and adjusts the gain in this one TGC acts only in 2D and TM 1 4 2 12 DEPTH Pot The DEPTH pot changes depth of current image 2D or TM It has no action in freeze mode Out of the depth range limits a beep sounds to warn the user 1 4 3 Keys for Frozen Image Study 1 4 3 1 BODYMHK The BODYMRK key displays the current
277. nnect additional peripherals directly to wall outlets use the outlet availa ble in the cart or a medical grade isolating transformer which must comply with IEC 601 1 specifications Wrong connections may compromise the electrical safety of the system KONTRON MEDICAL provides a medical grade isolating transformer on request see Chapter 6 3 KAccessories amp on page 6 5 for ordering a RJ 45 Network Isolator must be used for connecting the system to network Never connect Network RJ 45 directly to the system use a medical grade network isolator which must comply with IEC 601 1 specifications Wrong connections may compromise the electrical safety of the system KONTRON MEDICAL provides a medical grade isolator on request see Chapter 6 3 KAccessoriesS on page 6 5 for ordering 2 9 1 2 SIGMA 330 Expert a All equipments printers video recorders external TV monitors and other peripherals should be connected to the three isolated outputs provided by the system or powered through a medical grade isolating transformer when the system includes more than three peripherals or their total consumption exceeds 340 VA UN Never connect additional peripherals directly to wall outlets use the outlet availa ble in the cart or a medical grade isolating transformer which must comply with IEC 601 1 specifications Wrong connections may compromise the electrical safety of the system KONTRON MEDICAL provides a medical grade isolating transformer on
278. ntioned please contact your local service To get more information for using these peripherals consult their proper user s manual 2 9 3 Archiving on Personal Computer Archiving of digitized ultrasound images can be performed from SIGMA 110 SIGMA 330 systems to Personal Computer via PCMCIA Memory Cards a PCMCIA reader The recommended PCMCIA reader for PC is SCM MICROSYSTEMS SWAPBOX SBI D2P 10 12 01 INSTALLATION 2 17 AVA KONTRON MEDICAL 2 9 4 Connection of B amp W Video Printer The black amp white video printer must be connected to B W output of the SIGMA 110 SIGMA 330 This configuration is recommended for the MITSUBISHI P91 Black amp White video printer Black amp White VIDEO PRINTER Figure 2 10 B amp W Video Printer Connection 1 Reference 481 033 Remote control cable for Video Printer 2 Reference 862 169 Signal cable for Video Printer For optimizing the printout image quality set the DIP SWITCH and the control panel configura tion on P91 video printer DIP SWITCH CONTROL PANEL IMP 75 Ohms BRT 0 HIGH when ext monitor CONT 5 OFF Gamma 1 P TRAP OFF Print size 5 8 IMAGE POSI AFC OFF DIR REV MEMORY FRAME SCAN UNDER NTSC OVER PAL SAVING OFF PAPER HDS a SC setting is the largest print format b REV is for printing the first image on top of a paper stream For best print results use only K65HM paper 2 18 SIGMA 110 SIGMA 330 10 12 01
279. o User User User Wa L user selects curve using the trackball and validates his choice with the lt CURSOR_SET gt key A tick is displayed in front of the selected curve If the user wants to work with his own curves he selects the USER item A specific screen is displayed see Appendix F 5 User Table Sheet on page 7 47 The user can also display an ob gyn curve once the curve label is video inverted he presses the icon 7 44 SIGMA 110 SIGMA 330 15 10 01 Second page __OB GYN SE 14 02 01 08 30 31 THD Merz Hansmann User User APD FML Ramzin Bessis Bessis Hadlock erz Obri Camp User Jeanty Hohler AC erz Hadlock Hansmann erz Lai Yeo Lai Yeo User User Hu Merz L Lai Yeo User WEIGHT Shepard Campbell Hsieh Woo F 4 2 Short Description of Reference Tables The following table summarizes the reference tables For more information see the related page in appendix 7 ie Sound ve J Meas range Age range Errorrange Author locity m s wk wk Hadlock 1540 15 6 40 8 page 7 78 Merz 1540 12 5 41 5 page 7 79 Lai Yeo 1540 15 41 page 7 80 Bessis 1540 14 37 2 page 7 69 Merz 1540 12 5 41 5 page 7 70 Ramzin 1540 22 40 page 7 69 15 65 104 401 0 72 BPD Bessis 1540 1 9 9 7 11 6 39 9 0 8 4 5 page 7 49 BPD Campbell 1540 2 3 9 8 13 1 40 0 2 2 2
280. o Win Important note any Sono Win user with administrator privileges can change any data assign ment and so this document may not be up to date compared to modified settings Here only the default settings are described 3 19 5 1 Assignment of KIPRISM data to existing SonoWin parameters KIPRISM data are assigned to Sono Win parameters using a conversion table To check which values are assigned and which ones are ignored during this process click on the KIPRISM icon 4 in the Sono Win main window or select the menu item Window Kiprism This opens a window displaying the results of the assignment process Please refer to SonoWin 2000 User s Manual for more details 3 19 5 2 Assignment of KIPRISM data to user defined SonoWin parameters Some KIPRISM data are not assigned to Sono Win parameters The user can assign them to an existing parameter in an existing chapter see Section 3 19 5 1 on page 109 or create a specific chapter and or a specific parameter To do so select the menu item Window Measured Val ues or click on the corresponding icon in the SonoWin main window and then select Configuration in the system menu Please refer to SonoWin 2000 User s Manual for more details 3 19 5 3 Multiple Assignment of KIPRISM data to SonoWin parameters One SonoWin parameter may be mapped to more than one KIPRISM data see Appendix K for a detailed list The assignment of some measurements
281. o delete a result To delete a result 3 90 SIGMA 110 SIGMA 330 10 12 01 4 KONTRO MEDICAL 1 Select the field to be cleared a selected field is displayed in inverted video 2 Select the TRASH icon the selected field will be reset to zero By pressing F1 MEDICAL APPLICATION the user can change the medical application The CURVE VIEW icon is used to display the different curves from OB GYN STUDY sheet place the cursor on the measurement of interest when the field is highlighted press F3 CURVE VIEW the corresponding curve is displayed a from OB GYN SETUP sheet place the cursor on the name of the desired gestational table and press F3 CURVE VIEW the corresponding curve is displayed The Curve View sheet displays the selected curve the related measurement values and the Number of Weeks of Amenorrhea NWA Note that a point is displayed on the curve this point is the measurement of interest when NWA is less than 15 weeks else the displayed point matches with NWA See the different Biometry sheets in Chapter 7 APPENDICES on page 7 1 3 15 4 Report This function produces a document with all the measurement values calculation results and patient data reasonably arranged in patient report All information is shown in an explicit form The report can be displayed on the screen by pressing REPORT icon in the Biometry Study Menu The report can be printed on parallel printer by pressing P
282. o the Store menu key in FREEZE mode See Chapter 3 6 5 4 System on page 3 19 for PRINT2 configuration setting See Chapter 2 9 2 Recommended Peripherals on page 2 17 for recommended Video Printer 10 12 01 OPERATING INSTRUCTIONS 3 47 3 9 Cine Mode The Cine mode is a specific function used to analyse a biological movement This function allows the user to store in real time up to 282 images in the SIGMA 110 330 Memory with Cine Mode Option installed for SIGMA 110 The tables summarize the number of images or trace screens stored depending on format medical application and probe FORMAT 2D IMAGES TRACE SCREENS Linear probes Annular Sector AS probes Convex probes probes Radio Vasc Doppler Cardio Ob Gyn min max min max min max 2D 44 282 66 130 45 92 NA NA 2D TM 2Di Doppler 37 230 56 109 38 77 5 5 2Di Doppler 30 194 45 89 31 63 5 5 TM Doppler NA NA NA 16 16 Table 3 9 Cine Mode Memory in 2D FORMAT CFM CFM TM CFMi SP Table 3 10 Cine Mode Memory in CFM In CFM mode the number of images stored depends mainly on the angle of the 2D sector the number of trace screens stored is the same as in 2D These images can be displayed and analysed image by image on the SIGMA 110 330 screen This function is always activated for all modes and formats so the user can easily use it by pressing the FREEZE
283. ocity Time Integral 1 in cm VTI2 Velocity Time Integral 2 in cm 2 Area 2 with the Velocity Time Integral cm2 E 2 8 Resistance Index Pulsatility Index RI Resistance Index Pulsatility Index Vels Velocity at Systole in m s Veld Velocity at Diastole in m s Mean Velocity m s 7 32 SIGMA 110 SIGMA 330 15 10 01 Vels Veld Ratio Velocity Systole Diastole The resistance index can be either deduced from the PI calculation or computed separately Since it can be computed separately some parameters are duplicated E 3 Equations E 3 1 Velocity Time Integral Velocity Time Integral VTI in cm Vile Vj At D C v D 2 fo COS Vi Velocity in m s during each Dt in s of measured spectral area Df Doppler frequency in Herz Sound velocity 1540 m s fO Ultrasound frequency in Herz a Angle between the ultrasound beam and blood velocity E 3 2 Stenosis Percentage Stenosis percentage S s D 1 ver 100 Vell Vel Velocity on the stenosis in m s Vel2 Velocity before or after the stenosis in m s E 3 3 Stenosis Index Time Average Maximum Velocity in metres per second TAMX D VT Time VTI Velocity Time Integral Time Duration flow in seconds Stenosis Index STI STI p i 0 9 PkV TAMX Time Average Maximum Velocity in m s PkV Peak Velocity at systole in m s 15 10 01 APPENDICES 7 33 E 3 4 Ellipsoi
284. odules 1 38 SIGMA 110 SIGMA 330 15 10 01 Colour e CFM Energy Thermal Index ColMapx En xxdB TISx x or TIBx x or MI x x when the probe is a pencil probe or TIC x x when the probe is a TCD2 probe Mechanical Index MI xx x 1 5 32 2 2DJ TM Technical Data The techdata for the 2D and 2D TM modes are organized as described below Probe Probe Appl name Application Depth xx cm BGainxx 2D Gain Quality Freqt Smooth x Smooth Enhance Enh x Rej x Reject Gamma Gamma x Rainb x Rainbow Zoom Factor ag xx fps Frame Rate The Zoom Factor field is optional it contains the zoom or the magnify factor and will only be dis played if Mag or Zoom is on 1 5 3 3 2D TM Technical Data These ones contains the 2D data except the Zoom Factor and the TM data Probe Probe Appl name Application Depth xx cm BGainxx 2D Gain Quality Smooth x Smooth Enhance Enh x Rej x Reject Gamma Gamma x Rainb x Rainbow xx fps Frame Rate 1 5 34 TM Technical Data In this mode only the information relevant to the TM single pad are displayed Probe Probe Appl name Application Depth xx cm BGainxx 2D Gain Quality Freqt Enhance Enh x Rej x Reject Gamma Gamma x Rainb x Rainbow 1 5 3 5 Double 2D
285. ography FM Chang HC Ko BL Yao CH Wu J Formosan Med Assoc 1991 90 1086 92 3 Clinical Validation of Two Equations in Antenatal Prediction of Chinese Fetal Weight by Ultrasonography FM Chang HC Ko BL Yao CH Wu J Formosan Med Assoc 1991 90 1086 92 7 40 SIGMA 110 SIGMA 330 15 10 01 F2 TM SP Sheet F 2 1 Description 14 01 98 08 30 31 ER do EXAM N __ STUDIES HEART RATE _ b mn Velocity m s Frequency kHz ARTERIES Uterine L Uterine R Umbilical Cerebral PI TAMX m s VELs m s VELd m s EVELs VELd RI VELs m s VELd m s EVELs VELd EIL LL F 2 2 Second function keys page F 2 2 1 TM and SP Measurement Heart Rate Foetal Heart Rate in b mn F 2 2 2 SP Measurement a Velocity and Frequency measurement Velocity Velocity in m s Frequency Frequency in kHz When one of these fields is measured the others is automatically computed b Resistance and Pulsatility Index Four groups of measurement are available Uterine Left Uterine Right Umbilical and Cerebral For each group the following measurements are available 15 10 01 APPENDICES 7 41 MEDICAL Vels Velocity at Systole in
286. on press ESC to display the CFM live menu on page 3 43 for function details of the other buttons For Store and Archive function see Chapter 3 11 Digital Archiving KIPRISM on page 3 51 The following menu is displayed if colour is off camma store on cin achive See CFM live menu in Chapter From the previous menu Sub Application press ESC to display the CFM live menu on page 3 43 for function details of the buttons 3 7 5 5 Window Overview The colour flow mapping is related to the CFM Window The CFM Window is the region of interest where the user wants to display colour information The wider the CFM window is the slower the frame rate with an unchanged velocity range is Sizing and moving the CFM window is a simple mean for the user to define the first and the last CFM beam Q Moving and sizing CFM window CFM window size and position are changed using the trackball By pressing on one of the upper two trackball keys the user toggle the trackball assignment between these two oper ations The distinction is made by drawing a sign inside the displaced corner when the CFM window is sized Q Position limitation The position of the CFM window is limited in the angular and radial direction x and y direc tion for flat probes the CFM window cannot start at depth 0 e the selected PRF limits the scanned CFM depth When the user wants to exceed this limit the PRF is
287. on RI OGSPPIL Vels Systolic velocity uterine artery left computed on PI Vsyst AUTI OGSPRIL Vels Systolic velocity uterine artery left computed on RI OGSPPIR Vels Systolic velocity uterine artery right computed on PI Vsyst_AUT r OGSPRIR Vels Systolic velocity uterine artery right computed on RI ANCEQ_VTI1 VTI1 from vascular continuity equation ANSBI_MVI MVI from vascular spectral broadening index ANSI_VTI VTI from vascular stenosis index ANVTI VTI from vascular cardiac output ANBF_MVI MVI from vascular blood flow VTI2 ANCEQ VTI2 VTI2 from vascular continuity equation ANSBI VTI VTI from vascular spectral broadening index SIGMA 110 SIGMA 330 15 10 01 Appendix L Body Markers L 1 Vascular 1 YX Neck chin up 2 Neck left head up 3 lt gt Neck right head up 4 Body female 5 y Body male 6 x Body right 7 Body left 8 Leg back Leg front L 2 Radiology 10 12 13 14 15 16 17 18 cee 2 5 Le a f 7 Arm right Arm left Back Head face Head left Head right Neck Eye right Eye left Two sets of body markers are gathered under the radio application Abdominal body marker set 1 E Body female 2 v Body male 3 1 n Back B 4 x Body right 5 y Body left Paediatry body marker set 11 s Body 15 10 01 APPENDICES 2 9 Breast Neck with chin up Neck left head up Neck right h
288. onic Valve Area 1 computed from Diam1 7 100 AreaD SIGMA 110 SIGMA 330 Card D Pulmonic Valve 15 10 01 SP measures Description Sono Win Velocity Time Integral 1 VTl1 m Card D Pulmonic Valve Velocity Time Integral 2 VTI2 m Card D Pulmonic Valve Area 2 computed from VTI1 and VTI2 A1 Card D Pulmonic Valve Velocity 1 V1 Card D Pulmonic Valve Velocity 2 V2 Card D Pulmonic Valve Area 2 in cm2 computed from VEL1 and VEL2 K 2 4 4 Heart rate SP or TM measurement Description A2 Sono Win Card D Pulmonic Valve Chapter Heart rate on right ventricle Card D Pulmonic Valve 15 10 01 APPENDICES 7 101 H 4 KONTRON MEDICAL K 3 Vascular measurements K 3 1 Description Stenosis Percentage Sono Win Chapter Velocity on the stenosis VMT2 m s Angio Flow Volume Vmean Velocity before or after the stenosis VMB2 m s Angio Flow Volume Vmean Stenosis K 3 2 Stenosis Index Description D1 S Sono Win Angio Stenosis Chapter Velocity Time Integral VTI1 m Angio Flow Volume VTI Time Average Maximum Velocity VMB1 m s Angio Flow Volume VTI Peak Velocity VMT1 m s Angio Flow Volume VTI Stenosis Index K 3 3 Volume Description STI Sono Wi
289. onnector PCMCIA dedicated to software upgrade user setup storage and digital archiving KIPRISM RGB video output for external monitor and color video printer Parallel port for images and report printout Serial port for peripheral devices e USB port for data transfer to PC 1 8 13 Measurement CALIPERS Trackball controls the multiple callipers Complete measurement capabilities on frozen images 2D distance surface and circumference of area surface and circumference of ellipse angle volume distance and area ratio TM distance time slope heart rate distance and time ratio LV studies PW CW speed gradient frequency time acceleration integral amp RI RI heart rate speed gradient and time ratio CFM velocity velocity profile and frequency Specific measurements for OB GYN Up to 10 result lines on screen ANNOTATIONS Annotation lists user defined Text arrows body markers PATIENT REPORT Automatic selection of relevant measurement from patient report Comprehensive report for each medical application Radio Vasc Ob Gyn Pediatry Cardio 1 60 SIGMA 110 SIGMA 330 15 10 01 4 9 HA MEDICAL Peripheral vascular stenosis percentage continuity equation resistance index steno sis index pulsatility index spectral broadening index flow volume frequency Abdominal volume 1 to 4 user defined cardiac output diameter continuity equation Pediatric hip angles e Ob
290. ontrol panel illuminates The initialization sequence starts see Chapter 3 2 4 Initialization of SIGMA on page 3 5 3 2 3 Switching SIGMA 330 Excellence ON The power ON OFF sequence consists of 3 states Instrument OFF STAND BY ON To switch the instrument ON 1 Push both ON OFF power switches on the rear panel at the bottom and behind the mon itor of SIGMA 330 see figure 1 10 SIGMA 330 Expert rear panel on page 1 23 The green power indicator lamp located in front of the control panel will blink This light shows that the system is in wait state 2 When the power indicator lamp blinks press the ON OFF key on the keyboard or on the remote control A beep sounds when the program enters the start up procedure The green power indicator lamp located in front of the control panel illuminates The initialization sequence starts see Chapter 3 2 4 Initialization of SIGMA on page 3 5 The compact internal PC is automatically started the Flat Panel Monitor is lighted if not press the Power ON button and Starting up for Windows 2000 Pro appears on the PC screen 3 4 SIGMA 110 SIGMA 330 10 12 01 AVA BAY MEDICAL For operating SIGMA 330 Excellence or PC applications such as 3D Imaging see Chapter 3 7 6 SD imaging on page 3 46 and Chapter 3 20 Integrated PC SIGMA 330 Excellence on page 3 110 3 2 4 Initialization of SIGMA After a short delay the system displays the welcome
291. or a less echogenic patient Pressing Freq 4 decreases transmit ting frequency and displays Freq in the technical data area Pressing Freq T increases transmitting frequency and displays Freq in the technical data area on the right side of the screen Biopsy 1 2 Biopsy 1 displays the biopsy guide lines the screen in single 2D format According to the operating probe none one or two guide lines are available A biopsy kit including two needle guide inclinations can be fitted on the 6 5 MR multiplane tran srectal probe for this probe Biopsy 2 displays the second biopsy guide lines corresponding to the second inclination of needle guide Biopsy OFF is used to clear the screen of the lines 2D Inv This function reverses the up down orientation of the 2D image displayed on the screen a Left Right This function changes the left right orientation of the 2D image The KONTRON MEDICAL Logo at the top right left of the 2D image sector indicates the image orientation Tilt This function is used to tilt 2D angle It is useful with the transvaginal probe 6 5 EV only for ovarian exploration MP softpot shifts the image sector A graphic symbol shows the shooting angle direction AddFocus For Linear Convex probes it is possible to set up to four focus areas Select AddFocus to add a focal point Use the trackball to move it When 4 focus zones are selected pressing the AddFocus key sets the image back to
292. ored in the system for every probe and every application 2 Select the setup to be erased with the corresponding function key The confirmation menu is displayed 3 Answer Y Yes to confirm or C to cancel the erasing sequence 3 6 5 Preferences Press Prefs F4 function key of SETUP menu to display the preferences menu Date Display E Meee System Time The system displays the date According to the version PAL or NTSC the date is automatically displayed in a specific order DD MM Y YYY for the PAL version DD day MM month YYYY year MM DD Y YYY for the NTSC version DD day MM month YYYY year 3 6 5 1 Date Using the Date menu the user can modify the current date of the system The Date menu includes Day Month Year Validate and Abort keys 3 14 SIGMA 110 SIGMA 330 10 12 01 Day ver Year Abort To modify the day e g N gt 4 Press Date 1 Press Day F1 Rotate the softpot to get the right day Then press Validate F4 Proceed similarly for changing month and year 3 6 5 2 Display kHz eo Off Off Annot sernsave On Off Time Off Rent On Doppler scale m s or kHz Doppler information can be shown in m s or kHz Use m s Hz F1 function key to select the desired scale Patient Identification On Off Patient Identification can be displayed on the screen Use Pat ID F2 function key to dis play or not the Patient Identification Technical D
293. ormulation in this mode No data are reported for this operating condition since the global maximum index value is not reported for the reason listed 7 126 SIGMA 110 SIGMA 330 15 10 01 H 4 KONTRON BAY MEDICAL Transducer Model 3 5 MC Operating Mode PW mode TIS TIB TIC Index Label MI aha sgar Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value lt 401 32 b Pr3 MPa g Wo mW 93 5 min of W 21 3 24 mW Gi cm A 20 em 3 82 eq Zsp cm 0 40 i fc MHz 2 05 2 x cm 1 09 lt ow 1 2 msec 10 08 6 Hz p Pllmax 0 40 Focal Length ie c i i D FLy cm 3 W cm application Vasc 5 Doppler frequency MHz 2 gate size mm 8 6 velocity range kHz 3 2 energy dB 0 Notes a This index is not required for this operating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is
294. orrhea NWA D CurrentDate LMP LMP Last Menstrual Period Ratios BPD AT 25 lt lt ED 100 valid if 14 lt 40 weeks valid if 13 lt AUA lt 42 weeks FML 100 valid if 21 lt AUA lt 42 weeks AC FML AE pua lt lt BPD 100 valid if 23 lt AUA lt 40 weeks Cl Cephalic Index BPD Biparietal Diameter in cm OFD Occipital Frontal Diameter in cm HC Head Circumference in cm AC Abdominal Circumference in cm 7 38 SIGMA 110 SIGMA 330 15 10 01 Calculated abdominal circumference in cm iG Anterior Posterior Diameter cm TAD Transabdominal Diameter in cm Calculated head circumference in cm HC HC D X BPDQ OFD 2 BPD Biparietal Diameter in cm OFD Occipital frontal Diameter in cm Average ultrasound age in weeks and days AUA Average of non zero ultrasound age values calculated on BPD FML CRL AC HC values n UA AUA piDi Average Estimated birth date AEBD AEBD D CurrentDate 280 AUA AUA Average Ultrasound Age in days Foetal weight Weight Four methods are proposed the Shepard and Campbell methods are useful for western popula tion while Hsieh and Woo methods are for asian people Shepard method dependency on Abdominal Circumference and Biparietal Diameter measurements 2 646 AC BPD log o Weight D 1 2508 0 0 166 BPD Q 0 046 AC 00g AC Abdominal circumference in cm BPD Biparietal Diam
295. oth cable fasteners 2 connect the following cables 1 Reference 487155 VGA monitor cable for SIGMA 330 Excellence 3 Reference 485659 signal monitor cable for SIGMA 330 Expert 2 DC power cable Figure 2 2 Installation of the flat panel monitor 2 6 3 Installation of the integrated compact PC SIGMA 330 Excellence only After unpacking to assemble the PC into the cart a Mount both supports on the right and left side of the PC use the M5x6 screws mounted on the PC a Remove the lower panel from the lower compartment of the cart with screwdriver Pozidriv N 6 Place the PC in the lower compartment and connect the following cables see figure 2 3 Integrated PC rear panel on page 2 9 1 Reference 487163 USB cable between PC and USB connector of SIGMA 330 Excel lence 2 Reference 487163 USB cable between PC and your USB Hub or your USB periph eral if any 3 Reference 485519 Matrox Orion Video cable between PC and COLOR PR MONI TOR connector of SIGMA 330 Excellence only necessary for the 4870820E PC 3 4 Reference 487155 VGA Monitor Cable between and Flat 15 Monitor for the 487082E PC and 6 for the 4870820E PC 5 AC power cable to PC 6 2 8 SIGMA 110 SIGMA 330 10 12 01 m Nm 9 a Connect the small PS 2 PC keyboard to the PC 1 a Push the PC at the bottom of the compartment see figure 2 4 Wind up the panel again see figure 2 4 Reference 487775 DC power c
296. ou press on MEASURE key in SP mode SIGMA 110 330 displays the following menu depending on Medical Application a Cardio application Freq VTI eem page 1 PI amp RI Mitral Ratio o Acco er MVI 2 a Ob Gyn application Freq VTI page 1 ren be rato Juno ltt Le a other applications 3 82 SIGMA 110 SIGMA 330 10 12 01 Freq VTI Hearn page 1 rar rato unao e Le E Note that the Doppler vector angle must be carefully adjusted before the blood flow meas is started A message is displayed just above the menu when the measurement is entered Please check the position of the Doppler vector angle before the measure starts 3 14 6 1 Speed Gradient Measurement For the Speed Gradient measurement and the frequency measurement the start point is linked to the baseline and it can only be moved horizontally When the user turns the trackball in the vertical direction he moves the second point which gives the velocity this point can be moved in the positive and the negative areas 1 Press F1 SpeedGr to select speed gradient measurement 2 Usethe trackball to move the marker to the desired position 3 Press upper left SET key to fix the marker The result is automatically displayed on the screen The doted line sta
297. ptal thickness diastole in cm LVDd Left Ventricle Diameter diastole in cm PLVWd Left Ventricular posterior wall diastole in cm Left Ventricle Mass Index in grams per square meters LVMI LVM LVMI D BEA LVM Myocardial Mass in grams BSA Body Surface Area in m2 15 10 01 APPENDICES 7 15 AVA KONTRON MEDICAL e Left Ventricle circumferential in circumference per second VCF VCF p VPd LVDs LVDd LVET LVDd Left Ventricle Diameter diastole in cm LVDs Left Ventricle Diameter systole in cm LVET Left Ventricle Ejection Time in second Ejection Fraction in percent EF FD VOLd VOLs oa VOLd End diastolic Volume in cm3 Teichholz VOLs End systolic Volume in cm3 Teichholz Stroke Volume in millilitres SV Sv DVOLDs VOLSs VOLd End diastolic Volume cm3 Teichholz VOLs End systolic Volume in cm3 Teichholz Stroke Volume Index in millilitres per square meters 51 SI D SV BSA SV Stroke Volume in millilitres BSA Body Surface Area in m2 Cardiac Output in litres per minute CO 1000 SV Stroke Volume in cm2 HR Heart Rate in beats per minute Cardiac Output Index in litres per minute per square meters 5 Cardiac Output in litres per minute BSA Body Surface Area in m2 Ratio Left Ventricular Wall at diastole on Left Ventricle Radius at diastole H R IVSDdQ PLVWd H R D 7 16 SIGMA 110 SIGMA 330 15 10 01 H 4
298. r Vel key between power or velocity mode Zoom By pressing this button you can enter the Zoom mode a Col Off This button is used to hide the colour flow data The mode is changed from CFM to 2D All of the CFM menu keys are no longer selectable The 2D menu is displayed including the Col On key to switch back to CFM mode Tilt and Ad Focus items are not available when colour is off See Chapter 3 7 1 2 2D Live Menu on page 3 28 for details Angie Zoom Freq Biopsy page 1 2D Inv Right lt 1 1 smooth Reject 2 10 12 01 OPERATING INSTRUCTIONS 3 43 VelRange Pressing this button selects the velocity range which can be changed with the MP accord ing to the Doppler frequency Steer With this button the user can switch between three steering angles left straight and right The angle depends on the selected probe and the selected CFM transmit frequency Col Map Pressing this button selects the colour map which be changed with the MP 8 different colour maps are available Turb On Off Display or hide the turbulence colour information Resolu This key activates the changing of the colour flow resolution with the MP Three different resolutions are available Low Medium and High Freq This key activates the changing of the Doppler frequency according to the selected probe with the MP WallFilt This key activates the
299. r scale The colour scale is only displayed in CFM modes single or multi pad modes and is always associated to the grey scale when colour scale is displayed grey scale also displayed In this mode two different types of colour scales can be displayed the 128 colour levels are displayed in Power and Velocity mode if imaging of turbulence is activated in Velocity mode 32 colour levels and 96 turbulence levels distributed into 128 colours are displayed The colour baseline shift has no influence on the number of displayed colours which is always equal to 128 levels Colour amp Grey scale design 31 Baseline 4 Wall filter Velocity marker Range Colour Threshold 31 cm s Grey scale Unit Colour scale 1 5 1 3 Technical Data See Chapter 1 5 3 Technical Data Area on page 1 38 1 5 1 4 Measurement Results See Chapter 3 14 Measurements on page 3 67 1 34 SIGMA 110 SIGMA 330 15 10 01 B MEDICAL 1 5 1 5 Icons Four types of icons can be displayed on the SIGMA screen the freeze symbol icon 4 displayed when the system is frozen the magnify icon displayed when the 2D or CFM image is magnified the tilt icon displayed with tiltable probes 6 5 EV This symbol indicates the current scanned part the print icon temporary displayed when the user press on one of the two print keys 1 5 1 6 Zoom Indicator On the left side of the menu the range scale is drawn This scale loca
300. rd D Aortic Valve Effective Opening Area of the Aortic Valve EOA AREA V12 Card D Aortic Valve K 2 3 5 Ventricle Output Trunk 2D study Description Sono Win Chapter LVOT Diameter OT D mm Card D Aortic Valve LVOT Area OT AREA cm2 Card D Aortic Valve SP study Description Sono Win Chapter Velocity Time Integral cm VTI m Card D Aortic Valve Peak Velocity m s Vmax m s Card D Aortic Valve Peak Gradient mmHg peakPG mmHg Card D Aortic Valve Mean Gradient mmHg meanPG mmHg Card D Aortic Valve Stroke Volume ml SV ml Card D Aortic Valve Stroke Volume Index ml m2 Sl ml m2 Card D Aortic Valve Cardiac Output l min CO l min Card D Aortic Valve Cardiac Output Index l min m2 CI l min m2 Card D Aortic Valve K 2 3 6 Descending Aorta SP measurement Description SIGMA Sono Win Chapter Velocity Time Integral at VTIs AOdesc VTI s Card D Aortic Valve Systole Velocity Time Integral at Diastole VTId AOdesc VTI d Card D Aortic Valve Ratio VTI Diastole VTI Sys tole VTId VTIs VTI s Card D Aortic Valve 15 10 01 APPENDICES 7 99 AVA KONTRON HIN MEDICAL K 2 3 7 Heart Rate TM or SP measurement Description SIGMA Sono Win Chapter Heart Rate on aortic valve K 2 4 Right Ventricle study K 2 4 1 Pulmonic Valve 2D measures HR bpm HR bpm
301. rent modes In multi pad mode the common parameters i e Gamma Smooth are the ones of the active pad 1 5 3 1 Technical Data Formats Most of parameter values are preceded by a character label so that the user can easily identify their meaning In the following sections the different value formats are described xx means that 2 characters are displayed a Non labelled data Probe probe name including its working frequency Application the probe medical application Sub Application CFM mode name of the selected CFM Sub Application Liver amp Vein Kidney Abdom Artery Periph Artery Periph Vein and Fetal Heart or the scan ning method Scan Fast or Scan Normal in Cardio Depth xx cm Quality Freq or Freq Doppler frequency SPFreq x MHz Doppler mode CW or PW e CFM frequency CFMFreq x xMHz Frame rate in 2D and mode xx fps a Labelled data 2D Gain BGainxx Gamma Gamma x Rainbow Rainb x Enhance Enh x Reject Rej x Smooth Smoothx e Zoom Factor Mag x x Gate size Gatexxmm Spectral Wall filter WxxxxHz Vector Doppler Gain DGainxx Spectral Energy En xxdB CFM Gain CGainxx Resolution Res Low Res Med or Res Hi Persistence Pers x 1 The parameter Sub application is different from the biometry Medical Application The later is only relevant to annotation body marker measurement and biometry m
302. rent sub applications for his actual examination By selecting an appropriate sub application the optimum parameter set for the application is loaded Liver amp A Periph Fetal Periph Vein Kidney Artery Heart Vein The displayed sub application menu is dependent on the linear probe which is selected The sub application menu does not exist for Cardio application and the CFM live menu is dis played when pressing the CFM key 3 42 SIGMA 110 SIGMA 330 10 12 01 3 7 5 3 live menu From the previous menu Sub Application press ESC to display the CFM live menu mm zoom 1 Col Inv steers le t t page 2 persia 1 5 SubAppl This button displays the sub application menu described Chapter 3 7 5 2 Sub Applica tion Menu on page 3 42 to change between the different sub applications a Fast Normal In Cardiology Fast Normal replaces the SubAppl button This function modifies the frame rate Select Normal for a higher sensitivity and Fast for a higher Frame rate Baseline Pressing this button selects the CFM baseline shift which can be changed with the MP The actual baseline position is displayed at the left side of the colour scale see Chapter 1 5 1 2 Colour Grey Scale on page 1 34 The baseline position can be changed in 25 steps between 100 and 100 Pwr VelMode The user can select with the Powe
303. report and patient information saved on it can be read from the computer Note that no more PCMCIA card reader is required to archive the SRAM memory card content on a personal computer 3 18 2 Compatibility The USB Link option is compliant with a MacOS 9 or upper a Microsoft Windows 2000 with Service Pack 3 installed Please contact your local KONTRON MEDICAL representative for more information about sys tem requirements 3 18 3 Usage example with WindowsP 2000 3 18 3 1 Device identification When the SIGMA and the computer are not connected together typically you may have the fol lowing view from your file Explorer 545 File Edit Favorites Tools Help Ei Back fey search C Histoy GS X A Ea 314 Floppy Local Disk C Local Disk D E disk F A Control Panel 5 Computer 10 12 01 OPERATING INSTRUCTIONS 3 99 4 HA MEDICAL When the computer and the SIGMA are connected together the SIGMA is recognized as a removable device 215 File Edit View Favorites Tools Help Back A Search Us Folders E hHistory AS Ul Address KE my computer Go 314 Floppy Local Disk C Local Disk D disk F Removable Disk G Control Panel 5 Computer 3 18 3 2 List flashcard content If clicking on the removable disk device whereas no flashcard
304. request see Chapter 6 3 on page 6 5 for ordering 10 12 01 INSTALLATION 2 15 4 BAY MEDICAL 2 9 1 3 SIGMA 110 Light Master and SIGMA 330 Master a All equipments printers video recorders external TV monitors and other peripherals should be powered through a medical grade isolating transformer or connected via appro priate isolating accessories KONTRON MEDICAL provides the following isolating devices on request Peripheral Option Dedicated isolator Isolating transformer B amp W video Printer BNC Video Isolation Amplifier ref 488550 Colour Video Printer Isolation Transformer VCR S Video Isolator ref 488542 Parallel printer EasyPrint Printer Port Isolator ref 489859 Colour repetition monitor Isolation Transformer Colour flat panel repetition monitor S Video Isolator ref 488542 USB Link Isolation Transformer a When no dedicated isolating accessory is available the Isolation Transformer must be used KONTRON MEDICAL provides a medical grade isolating transformer and isolating acces sories on request see Chapter 6 3 Accessories on page 6 5 for ordering Maximum power of Isolation Transformer is 750 VA Sum of power of the different peripherals connected to the Isolation Transformer must be less than 475 VA ultrasound system requires less than 275 VA Isolation Transformer is recommended when two or more isolators are required
305. ress alphanumeric key 2 Aortic Valve Study Press alphanumeric key 3 e Right Ventricle Study Press alphanumeric key 4 Press the character corresponding to the first letter of the strings in the buttons to validate or cancel your action 3 18 SIGMA 110 SIGMA 330 10 12 01 Volumes The standard Radiology Study REPORT page is displayed The user can define the calcu lation type for the volume measurement 1 PRINT Config Renting KIPRISM Select Select Key Key Y Depth Printer Foot PCMCIA pag Encoder Setup Pedal Card Probe Select Probe selection at switching The Dialogue box allows the user to determine which probe is selected when the system starts At switching on the system searches probes that are connected and starts with the one that is selected in the dialogue box for probe preference configuration with one Linear Convex Probe 3 6 5 4 System Start looking for a probe on connector 1 P 1 Linear 2 P 2 1 3 P 3 Mech2 4 P 4 Pencil Cancel configuration with two Linear Convex Probes Start looking for a probe on connector 1 P 2 Mech1 2 P 3 Mech2 3 P 4 Pencil 4 P 5 Linear1 5 P 6 Linear2 Press on the character corresponding to the first letter of the strings the buttons to validat
306. rmal Index TIS provides information on temperature increase within soft homogeneous tissue 2 The Cranial Bone Thermal Index TIC indicates temperature increase of bone at or near the surface as may occur during a cranial exam 3 The Bone Thermal Index TIB provides information on temperature increase of bone at or near the focus after the beam has passed through soft tissue As with the Mechanical Index the Thermal Indices are relative indicator of temperature rise a higher value represents a higher temperature rise they indicate that the possibility for an increase in temperature exists and they provide a relative magnitude that can be used to imple ment ALARA The SIGMA 110 330 Acoustic Output Display SIGMA 110 SIGMA 330 15 10 01 H 4 KONTRON MEDICAL The SIGMA 110 330 displays the Acoustic Output Indices during live scanning to the right of the screen together with the transmit power setting and other technical data The following abbrevi ations are used Index Abbrevialion Mechanical Index MI Soft Tissue Thermal Index TIS Cranial Bone Thermal Index TIC Bone Thermal Index TIB The Output Display is organized to provide meaningful information to implement ALARA without distracting the user with unnecessary data Each time a user selects a new probe a choice of applications is provided Radio Vasc Ob Gyn Cardio depending on the selection the system will default the appropriate indices Not
307. rovide from A De Lavernette Kontron France Author Dr Hansmann 7 52 SIGMA 110 SIGMA 330 15 10 01 G 1 5 BPD from Merz 38 385 4 55 BPD from Merz EBD week week 4 amp EBD week BPD cm 6 1 5 1 Source Eberhard Merz Ultrasound in Gynecology and Obstetrics Textbook and Atlas 1991 Georg Thieme Verlag 15 10 01 APPENDICES 7 53 4 KONTRON MEDICAL G 1 6 BPD from Hobbins BPD EBD week LEB week d er BPD from Hobbins f EBD week HM EBD week 4 EBD week G 1 6 1 Source Chervenak F A Growth Assessment 7 54 3 4 BPD cm SIGMA 110 SIGMA 330 Jeanty P Hobbins J C Current Status of Fetal Age and 15 10 01 G 1 7 BPD from Hohler oen TT UN es EEE BPD from Hohler 4 6 BPD cm G 1 7 1 The table values have been adapted from Sabbagha by Hohler Sabbagha R E Hughey F amp M Standardization of Sonar Cephalometry and Gestational Age Obstet Gynecol 52 402 406 1978 15 10 01 APPENDICES 7 55 AVA KONTRON M DICAL G 1 8 BPD from Lai Yeo BPD cm EBD week 2 85 14 8 0 8 4 38 19 0 0 9 5 39 22 0 1 0 6 33 25 0 1 2 7 18 28 0 1 4 7 93 31 0 1 7 8 37 33 0 1 9 8 76 35 0 2 4 9 09 37 0 3 0 9 19 37 7 3 3
308. rst page FE The i icon is used to delete a field Pressing this key will delete the selected field video inverted field By selecting the icon the user displays the printable report of his measurement The icon is used to print the report on an external printer Pp The icon display the currently selected ob gyn curve i e the curve corresponding to the selected field in the master ob gyn page or the selected curve from the Ob gyn setup page Ln 0 The icon is used to change the working set of ob gyn growth curves Before starting a new study with new patient the user must press the T icon Doing so all the fields will be reset to zero is used to validate user s choice in setup user setup pages Doing so all the user s changes are recorded in NoVRAM If the user doesn t need to save his changes exists the displayed sheet using the ESCAPE key on keyboard The is used to exit the print preview and return to the previous screen 7 6 SIGMA 110 SIGMA 330 15 10 01 Appendix Patient Information C 1 First Page C 1 1 Description The user enters this page when he presses on the lt PATID gt key while an ultrasound image is displayed 14 02 01 08 30 31 LABORATORY INFORMATION Page 1 LAB ee PHYSICIAN
309. s Typical accuracy e Distance lt 3 1 mm when 3 of the measured value is less than 1 mm Angle lt 2 59 Distance lt 1 0 5 mm when 1 of the meas ured value is less than 0 5 mm lt 196 lt 2 Speed lt 5 of max displayed velocity Frequency lt 5 of max displayed frequency Gradient lt 10 Time lt 1 Acceleration lt 10 Heart rate computed by ECG Table 1 4 Measurement Accuracy SIGMA 110 SIGMA 330 15 10 01 1 7 12 Acoustic Power SIGMA 110 complies with the FDA Standards Acoustic power depends on Medical Application e Isppa lt 190 W cm2 Medical Application independent e im lt 310 W cm2 Medical Application independent e Ispra in situ in mW cm MEDICAL AEP CARDIO RADIO OB GYN situ in mW cm 430 94 Table 1 5 Acoustic Intensity Accuracy of MI display 30 96 Accuracy of TI display 50 96 1 7 13 Environment TEMPERATURE Operating temperature 10 C to 40 C 50 F to 104 F Storage temperature 20 C to 40 C 4 F to 104 F HUMIDITY Operating humidity 30 to 80 non condensing Storage humidity 30 to 95 non condensing ATMOSPHERIC PRESSURE Operating pressure 700 mbar to 1060 mbar Storage pressure 500 mbar to 1060 mbar ELECTRICAL SPECIFICATIONS Input voltage 100 12
310. s configuration Q 3 6 7 Backup Configuration The function key Backup Config F1 backs up the user configuration laboratory operator and physician names Ob Gyn setup and user reference tables user probe setup and pref erences on the memory card This operation must be done periodically and before any software update Restore Configuration The function key Restore Config F2 restores the user configuration saved on the mem ory card and replaces the current settings with the restored ones List Content The function key List Content F3 lists a summary of the memory card content the labo ratory operator and physician names and the probe setup names Format The function key Format F4 formats the memory card for digital archiving of ultrasound images Battery Check The function key Battery Check F5 checks the battery charge level of the memory card The following messages are returned BATTERY STATE Full 100 normal operating conditions LOW BATTERY exchange the battery as soon as possible EMPTY BATTERY replace the battery immediately System Info Boards Software Software Power on Key page 1 version ext ver stats historic 2 Time page Renting The System Information Menu allows the user to display 10 12 01 installed boards and their version software version OPERATING INSTRUCTIONS 3 23 3 24 extended software versions power on statistics key historic tim
311. screen Printer Version 5 Doppler icon VLCUS PRESENT 05 COL_DOP PRESENT 04 LINEAR PRESENT 05 icon SWITCH BOX PRESENT CINE PRESENT Iris SUBSI PRESENT 01 icon ECG PRESENT VIDEO TYPE PAL Cardio css KEYBOARD 2 10 Storage Le a S l icon a SIGMA xxx displays the SIGMA type 110 Light 110 or 330 a The software version and the installed hardware are displayed a SIGMA configuration icons Description Description P features and colour monitor Print option is available Displayed when Easy Iris icon means that the Iris Ir are available Cardio features are available Doppler icon means that iha Cardio icon means that the available CFM icon means that the KIPRISM icon means the Colour Doppler features Col quf Digital Storage features our Flow Mapping are avail able KIPRISM available Displayed when USB Link option is available A progress bar indicates the machine is initialising Then the 2D image area and PROBE Menu are displayed except when a user setup shows another mode Note After turning the system off always wait five to ten seconds before turning the power on again 10 12 01 OPERATING INSTRUCTIONS 3 5 AVA KONTRON MEDICAL 3 3 Switching the Instrument OFF 3 3 1 Switching OFF SIGMA 110 and SIGMA 330 To switch the ins
312. settings The user preferences for the printer are available from the second page of the Preference Sys tem Menu SETUP gt Prefs gt System DEPTH Printer Foot page 2 Encoder Setup Pedal E 2 26 SIGMA 110 SIGMA 330 10 12 01 4 HA MEDICAL When Printer Setup key is pressed F2 key the following screen is displayed 14 02 01 08 30 31 GENERAL Images per page 1 742 Background color 3 4 5 5 6 Paper size VA4 Font type Courier US Letter YTimes Univers Paper type VPlain Glossy Print borders Yves No Transparency Print head foot Yves No Background printing WYes No General opu Gamma Default The button General 1 key is automatically selected and general printer parameters dis played The selection of a parameter is easy the cursor is placed on a field of interest the corre sponding text is display in inverse video This field is selected using the up left trackball key a tick mark is displayed in front of it Note that only one parameter can be selected in a group paper size paper type The different groups are explained below Once all the desired parameters are chosen the user selection is validated by leaving the Printer Setup menu with ESC The NoVRAM is then updated The Default key restores the default values and stores them in the NoVRAM The default values are given in the following sections General
313. stem transducer no more or not currently available bad transducer code is read due to probe or transducer cable defect the connector on the system is broken or has contact problems LA DSP sends bad transducers codes If one of the both message persists the user must inform the service team 5 4 1 2 Warning 0 NOVRAM reset After a software upgrade the non volatile NOVRAM is reset to guarantee its content So before upgrading the software the current configuration will be saved on the delivered flash card SRAM menu SETUP PCMCIA CARD BACKUP CONFIG and restored after software upgrade menu SETUP PCMCIA CARD RESTORE CONFIG gt Note the restore operation can not be done for a version below V5 00 i e V2 50 to a V 5 XX version Chapter 5 5 2 LError 1 Can not restore backed up configurationblon page 5 18 Warning 0 NOVRAM reset The software has been upgraded The NOVRAM has been reset The user setups are lost ES 15 10 01 TROUBLESHOOTING 5 9 AVA KONTRON MEDICAL 5 4 1 3 Warning 1 Backed up RAM reset Two different cases can involve a backed up RAM reset e the backed up RAM content is corrupted checked at system start up e failure in the backed up RAM battery Warning 1 Backed up RAM reset The backed up RAM has been reset The user setups have been lost Please signal this problem to your service team 9 5 4 1 4 Warning 2 Transducer ha
314. system e Mechanical transducer broken or locked e g transducer motor problems Call service to signal probe problem Problem on probe cable Problem on VLCUS board 5 5 4 Error 3 Memory allocation error Fatal error The memory allocation error message do not cause a lock of the system but the current action e g add new annotation can not be performed If the user wants to use this function he should restart the system If the problem persists the user should inform the service team 5 5 5 Error 4 Divide by 0 Fatal error The divide by 0 error message is displayed when a divide by 0 happens in the software e g cor rupted stack corrupted data by stack overflow When its happens the system is locked and the user should restart it by using the switch ON OFF button If the problem persists the user should inform the service team 5 5 6 Error 5 Communication error An error has occurred on the COM1 serial port If the problem persists the user should inform the service team 5 5 7 Error 6 Flash card read error The content of the flashcard can not been read it may be broken The user should change the flashcard If the problem persists the user should inform the service team 5 5 8 Error 7 Flash card write error The system can not write on the current plugged flashcard the flashcard is write protected the user should remove the write protection the flashcard is broken the user should change the flashcard
315. system type a warning is displayed e g system type SIGMA 110 Light on which no COL DOP board should be connected Warning 4 Invalid configuration gt SIGMA 110 Light COL board PRESENT ox This message is displayed at each system start up until the non authorized hardware is removed by the service team 5 4 3 Flash card and SRAM 5 4 8 1 Warning 5 Flash card not present Displayed when trying to store images without a flashcard plugged A SRAM should be plugged Warning 5 Flashcard not present Please plug a SRAM flashcard 5 4 3 2 Warning 6 Flash card is write protected The current plugged flash card is write protected the user should change the flash card or remove the write protection Warning 6 Flashcard is write protected 15 10 01 TROUBLESHOOTING 5 11 AVA KONTRON MEDICAL 5 4 33 Warning 7 SRAM battery status The SRAM battery state is checked when the user plugs a SRAM If the SRAM battery is low or empty one of the following message is displayed and the user should replace the battery Warning 7 SRAM status battery Warning 7 SRAM status battery is low Can maintain data integrity is empty Can not maintain data integrity Change battery ASAP Change battery now When the second message is displayed empty battery the saved data could be lost The battery state can also be checked via the PCMCIA menu 5 4 8 4 Warning 8 No data to restore This warning
316. t Now the user can move the trackball and finish the measurement the report sheet is displayed again and all the related fields are updated main field results fields and computed fields if all data are availa ble abort the measurement and return to the report screen he presses on the ESCAPE keyboard key no field is modified abort the measurement exit the report and return to a live image he presses on the FREEZE key no field is modified When is a measurement possible to do Each measurement is associated to a specific mode For example 2D for area TM for time SP for velocity integral A measurement is possible to do if its related mode was displayed at screen just before the user entered the report The table below summarizes all the possible states System mode Auhorized Comments measurements 2D or CFM 2D measurements Double 2D 2D measurements Quad 2D 2D measurements Zoom 2D measurements 2D TM or 2D measurements if TM is active switch on 2D pad CFM TM TM measurements if 2D is active switch on TM pad TM TM measurements 2D measurements if SP is active switch on 2D pad 2D SP SP measurements if 2D is active switch on SP pad 2Di SP or 2D measurements if SP is active switch on 2D pad CFMi SP SP measurements if 2D is active switch SP pad 15 10 01 APPENDICES 7 89 1 1 2 Special Cases 1 1 2 1 Cardiac Output Diameter This field duplicates t
317. t and time ratio Specific measurements for OB GYN Up to 10 result lines on screen 15 10 01 INSTRUMENT DESCRIPTION 1 49 AVA KONTRON M DICAL ANNOTATIONS Annotation collection Text arrows body markers PATIENT REPORT Automatic selection of relevant measurement from patient report Comprehensive report for each medical application Radio Vasc Ob Gyn Pediatry Cardio Peripheral vascular stenosis percentage continuity equation resistance index steno sis index pulsatility index spectral broadening index flow volume frequency Abdominal volume 1 to 4 user defined cardiac output diameter continuity equation Pediatric hip angles Ob Gyn extensive measurements capabilities including BPD FML CRL BOD ABD THD AC GES HC OFD APD TAD Foetal Weight Estimated Birth Date Cardio left ventricular volumetry using Simpson area length single and bi plane formu las systolic and diastolic volume using Teichholz rule shortening fraction myocardial mass and mass index left ventricular circumference ejection fraction cardiac output and index stroke volume and index mean velocity pressure and mean pressure gradi ent pressure half time and valve area time to peak velocity in systole right and left ven tricular ejection time and pre ejection period right ventricular systolic pressure continuity equation QP QS All applications body surface area BSA ME ASUREMENT ACCURACY Parameter
318. t b lt no rmal gt rmal gt see see lt nor lt nor mal gt lt HUM mal gt lt Humerus Length HuL super HUM_WEK super Ob Fet 1 script HUM_SD script gt a lt no gt b lt no rmal gt rmal gt see see lt nor lt nor mal gt lt AC mal gt lt Computed Abdominal Circumference AC super AC_WEK super Ob Fet 1 script AC_SD script gt a lt no gt b lt no rmal gt rmal gt see see lt nor lt nor mal gt lt HC mal gt lt Computed Head Circumference HC super HC_WEK super Ob Fet 1 script HC_SD script gt a lt no gt b lt no rmal gt rmal gt Cephalic Index BPD OFD Cl Cl Ob Fet 1 15 10 01 APPENDICES 7 105 Description Sono Win Chapter Head Circumference Abdominal Circum ference Femur Length Abdominal Circumference FL AC Ob Fet 1 Femur Length Biparietal Diameter FML BPD Ob Fet 1 Foetal Weight in gramms WEIGHT Ob Fet 1 Uncertainty in gramms Ob Fet 1 HC AC Ob Fet 1 Average Ultrasound Age Patient data Average Estimated Birth Date Patient data a This measure is defined on the SIGMA by a distance in cm an estimated fetal age in weeks and days and an uncertainty in weeks and days on the fetal age b This measure is defined on SonoWin by a distance in mm an estimated fetal age in weeks and days and an uncertainty in weeks and days on the fetal age K 4 2 SP measures K 4 2 1 Heart Rate Description Sono Win Chapter Heart rate
319. t sheet is displayed 1 4 1 2 POWER ON OFF Key The POWER key switches ON or OFF system power For Power OFF a confirmation menu is dis played with a key for action aborting This is to prevent a user manipulation error 1 4 1 3 MENU Key The MENU key is a toggle key displaying and hiding the menu of current functions This menu is depending on the current state and mode The lt PREVIOUS and gt NEXT keys located close right of the function keys are used to access the next previous menu page if other menu pages are available Oo F1 F2 F3 F4 F5 5 F6 F7 F8 F9 F10 1 4 1 4 F1 to F10 Keys Select functions displayed in menu on the screen If it is an action function the action is immedi ately performed If itis an adjustment function this can be recognized by the symbol on screen the user has to make an adjustment using the potentiometer on the left of the function keys 1 4 1 5 ID Key The ID key calls the starting page and menu for entering new patient information laboratory and operator identification 1 28 SIGMA 110 SIGMA 330 15 10 01 1 4 1 6 PROBE The PROBE key displays the probe MENU showing the names of the connected probes User can select the operating probe On probe selection the corresponding probe setups are loaded and live image starts 1 4 1 7 SETUP Key The SETUP key displays a menu giving an user action choice on setups and preferences
320. ta FL 2 06 Len 8 3 FLy 7 206 IpA 3Mlmax W cm application Vasc Vasc amp Doppler frequency MHz 8 8 gate size mm 8 8 velocity range kHz 3 2 3 2 energy dB 0 0 Notes a This index is not required for this operating mode see section 4 1 3 1 of the Output Display Standard NEMA UD 3 b This probe is not intended for transcranial or neonatal cephalic uses c This formulation for TIS is less than that for an alternate formulation in this mode No data are reported for this operating condition since the global maximum index value is not reported for the reason listed 7 118 SIGMA 110 SIGMA 330 15 10 01 H 4 KONTRON HIN MEDICAL Transducer Model 7 5 MHz LVS Operating Mode PW mode TIS TIB TIC non scan Index Label MI non sgar Aaprt Aaprt scan lt 1 gt 1 Global Maximum Index value a 1 7 1 0 b Pr3 MPa 2 Wo mW 33 7 min of W 3 z1 IrA 3 z4 mW 17 0 Gi cm 1 20 A bp 1 20 Zsp cm 2 23 8 deq Zsp cm 0 30 fe MHz 819 8 19 2 0 77 0 77 Im O 2 0 65 0 65 PD msec 10 5 10 5 6 Hz 5 deq Plimax 0 29 Se ere FLy cm 2 34 Len E i FL om es ek
321. taining all electronic modules Keyboard panel Black and White or colour video monitor Stereo audio system for Doppler Video Cassette Recorder output Black amp White and colour Printer output The SIGMA 110 Light SIGMA 110 Master and the SIGMA 330 Master consist of the basic SIGMA 110 330 and a transducer holder kit for two transducers and for a bottle of ultrasonic gel A front view of these versions and the front panel opened showing the keyboard and screen are shown in figure 1 1 SIGMA 110 Light Master and SIGMA 330 Master on page 1 8 The SIGMA 330 Expert consists of the basic SIGMA 110 330 system combined with an inte grated cart which provides Room for optional Video Cassette Recorder Room for optional Printers Room for accessories Elevating column for user adaptative height The pedal on the base of the instrument is used to control the desired position press the pedal to lift up while keeping the pedal depressed push down the column top part to get it down In addition to the SIGMA 330 Expert features the SIGMA 330 Excellence includes a flat screen associated with an integrated personal computer for 3D imaging and patient data management 15 10 01 INSTRUMENT DESCRIPTION 1 7 Figure 1 1 SIGMA 110 Light Master and SIGMA 330 Master SIGMA 110 SIGMA 330 15 10 01 15 10 01 Figure 1 2 SIGMA 330 Expert INSTRUMENT DESCRIPTION 1 10 Figure 1 3 SIGMA 330 Excellence SIG
322. tential for mechanical effects is thought to increase as peak rar efactional pressure increases but decrease as the ultrasound frequency increases Although there have been no adverse mechanical bioeffects in humans from diagnostic ultra sound exposure it is not possible to specify thresholds at which cavitation will occur in mammals Thermal Bioeffects are the rise in temperature of tissue when exposed to acoustic energy The acoustic energy is absorbed by body tissue absorption is the conversion of this energy into heat If the rate of energy deposition in a particular region exceeds the ability to dissipate the heat the local temperature will rise The rise in temperature will depend on the amount of energy the vol ume of exposure and the thermal characteristics of the tissue On Screen Real Time Acoustic Output Display Until recently application specific output limits established by the USA Food and Drug Adminis tration FDA and the user s knowledge of equipment controls and patient body characteristics have been the means of minimizing exposure Now more information is available through a new feature named the Acoustic Output Display The Output Display provides users with information that can be specifically applied to ALARA It eliminates some of the guess work and provides both an indication of what may actually be happening within the patient i e the potential for bio effects and what occurs when system control settings ar
323. tes the zoomed part of the 2D image By moving the trackball up or down the current displayed area will be moved and the zoom range indicator will be modified Zoom range indicator 1 5 1 7 ECG Menu and ECG pads are always displayed one above the other The menu is always displayed The colour of the ECG trace is CYAN with a colour monitor and WHITE with a B W monitor 1 5 1 8 Auto Frequency Adjustment AFA The Auto Frequency Adjustment marker A F A shows the current ultrasound working frequency bandwidth of the transducer in 2D This working frequency bandwidth depends on actual selected scan depth and on the Freq Freq setting For each transducer depth and frequency setting A F A selects the optimal fre quency bandwidth of the transducer A F A is available in single 2D mode and Freeze mode AFA display is selectable in the Preferences Menu MHz MHz 15 10 01 INSTRUMENT DESCRIPTION AVA KONTRON MEDICAL 1 5 2 Menu 1 5 2 1 Function Key Menu Function Keys on the keyboard are named F1 to F10 and Menu Items on the screen M1 to M10 to get understanding of the following description easier MP as Menu Potentiometer is for the incremental potentiometer MK is for the MENU key is for the PREVIOUS key gt is for the NEXT key Function Keys F1 to F10 are respectively attached to the corresponding Menu Items M1 to M10 e g pressing F1 acts on M1
324. the desired position A doted line appears to show the position of the distance measurement 5 Press upper left SET key The result is automatically displayed on the screen The doted line stays if the preference doted line has been selected in the set up preference menu The doted line disappears if the preference no doted line has been selected in the set up preference menu During the measurement the user can delete a part of the current measurement by pressing on the BACKSPACE lt key Distance results are always in millimetres 10 12 01 OPERATING INSTRUCTIONS 3 69 AVA KONTRON MEDICAL 3 14 3 2 Measuring an Area Technical Data OL be Press F2 Area to select area measurement Use the trackball to move the first marker to the desired position Press upper left SET key to fix the marker the second marker is now available Use the trackball to move the marker and draw the area there are two ways of finishing the measurement Press upper left SET key The result is automatically displayed on the screen e Return on the start point of the area measurement when the two markers are super posed the area measurement is ended OTE I During the measurement the user can delete a part of the current curve by pressing on the BACKSPACE lt key For this measurement two results are displayed the area in square centimetres and the circum ference perimeter in centimetres 3 14
325. the two end points of the dis tance to be measured Preference for No line there is no line between the two points Press on the character corresponding to the first letter of the strings in the buttons to select your option 10 12 01 OPERATING INSTRUCTIONS 3 17 LV Study default mode for LV Study LV Study setup for REPORT preference is now Full Full Abbr LV Study can be initialized in two different modes User can select either Full LV study or Abbreviated LV study with LV Study F4 function key Press on the character corresponding to the first letter of the strings in the buttons to select your option VTI default mode for measurement VTI measurement mode preference is now Auto Auto VTI measurement be initialized either in Automatic or in Manual mode with Meas function key F3 Press on the character corresponding to the first letter of the strings in the buttons to select your option a Cardio setup Cardio new study start up page Left ventricle study Mitral valve study Aortic valve study IB lo N lA Right ventricle study Ok With this dialogue box the user can select the page which is to be displayed each time new Cardio Study is displayed Left Ventricle Study Press alphanumeric key 1 Mitral Valve Study P
326. the zoomed area is displayed Figure 1 18 2D Display Modes 1 6 22 Modes 2D or CFM TM Figure 1 19 Display Modes 1 42 SIGMA 110 SIGMA 330 15 10 01 H 4 KONTRON HIN MEDICAL 1 63 CW and PW Modes 2D CW 2Di CW 2D or CFM PW 2Di CFMi PW Figure 1 20 CW and PW Display Modes Remark the CFM CW modes are not available because the CFM is only possible with linear probes and the CW mode only with mechanical or pencil probes 1 6 4 CFM Formats CFM Linear zoom oe Magnified CFM only the zoomed areas are displayed magnified zone Figure 1 21 CFM Display These formats are only available for linear transducers It is composed of 2 images displayed one over the other the 2D image on the back and the Colour Flow Mapping image on the front 15 10 01 INSTRUMENT DESCRIPTION 1 43 AVA KONTRON MEDICAL 1 7 SIGMA 110 Technical Specifications 1 7 1 General The SIGMA 110 is a 2D TM and spectral Doppler transportable ultrasound scanner for general purpose applications Abdominal Breast Cardiology Emergency Endocrinology Gastro enterology Gynaecology Obstetrics Paediatrics Small parts Musculoskeletal Neonatology Urology Vascular SCANNING TECHNIQUE
327. ting of OR RN M ABEL 3 98 3 18 USB Link M in la dm ri uocis ac 3 99 MEG Eu aan 3 99 ro pa ho fromm 3 99 3 18 3 Usage example with Windows 2000 3 99 3 18 4 Read data from a computer tttttrrrnnennnnnn nn 3 101 SIGMA 110 SIGMA 330 10 12 01 H 4 KONTRON HIN MEDICAL 3 18 5 Copy data to the 3 101 18 6 udnitertace With PAS oil te ea earned desine 3 102 3 187 eo rre 3 102 3 19 SonoWin Lite and SonoWin Basic PACS 3 103 SMS MISI p 3 103 3419 2 cou Ce RH ceases 3 104 3 19 3 Save images reports and patient information 3 105 3 19 4 Transfer data to SonoWIr G9 ioco co rie 3 106 3 19 5 ASSIGDPOHL ssi cra dr iow ee oles cee ma ems 3 109 3 20 Integrated PC SIGMA 330 3 110 3 201 OVErV EW fis ed uta ea uh od to o dd dde Se E ET 3 110 3 20 2 SAFETY PRECAUTIONS iiie
328. tion 5 sliders Dynamic focusing on reception Up to four focus zones on transmission Automatic adjustment of reception bandwidth for each depth Contour enhancement 7 positions application dedicated Dynamic range control reject 4 positions to increase the contrast and reduce weak echoes Frame filter 4 non linear smoothing filters OFF position 15 10 01 INSTRUMENT DESCRIPTION 1 55 Automatic Frequency Adjustment A F A for standard and less echogenic patient Freq Freq Grey scale optimization thanks to 8 Gamma curves probe dependent e ris colour system IMAGE PRESENTATION Single Double and Quad image representation Freeze mode e Left right Up Down Video inversion RESOLUTION e 512 x 512 pixels on screen for 2D image display 256 grey levels IMAGE MEMORY Cine Mode up to 282 images probe and medical application dependent 1 8 3 TM M Mode SIGNAL PROCESSING Same as 2D mode IMAGING PARAMETERS Scrolling speed 2 3 5 8 sec screen full screen e 1 1 5 2 5 4 sec screen 2D TM M LINE STEERING Trackball controlled over complete 2D sector DISPLAY 2D 50 screen TM 50 screen Full screen TM IMAGE MEMORY Cine Mode upto 16 trace screens in full TM upto 5 trace screens in 2D TM 1 8 4 Spectral Doppler Mode AVAILABLE MODES Steerable PW and CW e Multi frequency Doppler modes Spectral colorization e Automatic 2D image update when adjusting Doppl
329. to the preamendments FDA limit for peripheral vascular applications which is 720 mW cm The maximum output for a given probe can be less than the system limit since the maximum depends on a variety of elements crystal efficiency mode of operation etc It is normally reached with the Vasc setup at minimum depth or maximum PRF and in CFM with the smallest CFM window size All terms are defined in Section 1II 2 6 Glossary and definition of terms on page xxviii The SIGMA 110 330 Acoustic Output Controls Control features may be divided into three categories 1 controls which directly affect the intensity direct controls 2 controls which indirectly affect the intensity indirect controls 3 controls which do not affect the intensity such as the gains and the processing curves Controls which directly affect the intensity the Application selection which establishes the appropriate range of intensities see Maxi mum Output Section the Energy control for Doppler modes which allows to increase or decrease the output inten sity within the range of the selected application Controls which indirectly affect the intensity This category includes controls which change several aspects of the transmitted ultrasonic field rather than the intensity Intensity is affected because of the field variations Each mode has its xxvi SIGMA 110 SIGMA 330 15 10 01 4 KONTRO MEDICAL own pulse repetition frequency PRF
330. tput Voltage Power rating CAUTION When the SIGMA 330 System includes more than three peripherals or must provide more than 340 VA the additional peripherals must be supplied through a medical grade isolat ing transformer Never connect them directly to wall outlets See Chapter 1 2 1 Safetyfl on page xix 10 12 01 INSTALLATION 2 11 2 8 Connecting a Probe 2 8 1 SIGMA 330 Expert and SIGMA 330 Excellence Probe Assignment c EAR Figure 2 5 SIGMA 330 Expert Excellence probe assignment Both P 2 and P 3 ports dedicated to Annular Sectorial probes AS the P 4 port to Doppler pencil probes and the P 5 and P 6 ports to Linear Convex probes are assigned in the probe menu as shown in figure 2 5 SIGMA 330 Expert Excellence probe assignment on page 2 12 and in Chapter 3 5 2 2 Probe Main Menu with Two Linear Probes on page 3 12 2 12 SIGMA 110 SIGMA 330 10 12 01 AVA MEDICAL 2 8 22 SIGMA 110 Light Master SIGMA 330 Master Probe Assignment e At Ey Figure 2 6 SIGMA 110 Light Master and SIGMA 330 Master probe assignment The P 1 port dedicated to Linear Convex probes both P 2 and P 3 ports to Annular Secto rial probes AS and the P 4 port to Doppler pencil probes are assigned in the probe menu as shown in figure 2 6 SIGMA 110 Light Master and SIGMA 330 Master probe assignment on page 2 13 and in Chapter 3 5 2 1
331. trace screens in 2D Doppler ACOUSTIC POWER OUTPUT Fulfils acoustic output display standards Complies with FDA acoustic output limits Automatic power output adjustment versus medical application for optimal Doppler per formance ALARA User selectable Doppler transmit power attenuation 8 positions between 0 dB and 21 dB 1 7 5 Digital Archiving KIPRISM Digital archiving on Memory Card the number of ultrasound images which can be stored is depending on memory card capacity up to 32 images on 4 megabytes memory card up to 64 images on 8 megabytes memory card eic Transfer on Personal Computer via memory card PCMCIA standard DOS format 1 7 6 ECG Module option FORMATS for all single or dual pad formats INPUT solated input type CF Defibrillator proof IEC 601 1 through serial port 240 x 8 bit second QRS trigger available ECG Gain 1000 1V 1 mV Heart rate up to 180 bpm Recovery time after defibrillator shock gt 5 sec B MODE TRIGGER in single and dual B mode available trigger moment may be set by user For dual pad modes two independent triggers can be set DISPLAY and CINE REVIEW Display trace on video screen Indication of time relationship between 2D mode image and ECG trace by marker on ECG trace Cine review on trace modes is also available 1 48 SIGMA 110 SIGMA 330 15 10 01 1 7 7 EasyPrint Direct output to inkjet printer Compatible with HP PCL
332. transformer max 750 VA DOC31001EN Operator Manual SIGMA 110 330 English DOC31002EN Service Manual SIGMA 110 330 English DOC31004EN 10 12 01 Operator Manual 3D Vascular Fetal View English Table 6 4 Accessories OPTIONS AND ACCESSORIES 6 5 Reference Designation 462 489 Medical Ultrasound Safety Guide 870072 Printer cable Par Bi direct Subd 25M Centronic 36M L 1 8 488 216 RJ 45 Network isolator 482 951 Handle for SIGMA 110 and SIGMA 330 Master 462 519 Wall shelf 489 336 External FireWire 1 3 GB Magneto Optical Disk Drive 489 506 Re writable 1 3 GB Magneto Optical Disk 488 763 Kit of 10 air filters NA HEWLETT PACKARD Deskjet 990Cxi local purchasing NA amp W Video Printer MITSUBISHI P91E local purchasing NA B amp W Video Printer SONY UP890MD local purchasing NA Colour Video Printer MITSUBISHI CP700E local purchasing NA B amp W VHS VCR local purchasing NA Additional B amp W Monitor local purchasing Table 6 4 Accessories 6 6 SIGMA 110 SIGMA 330 10 12 01 15 10 01 7 APPENDICES APPENDICES 7 2 SIGMA 110 SIGMA 330 15 10 01 Appendix Overview A 1 Entering the Biometry To enter the Biometry press lt REPORT gt key The image is automatically frozen if needed and according to the current medical application Radio ObGyn and current mode 2D TM a specific biometry screen is disp
333. troke Volume Index m m2 Sl ml m2 Card D Aortic Valve Cardiac Output l min Card D Aortic Valve Cardiac Output Index K 2 3 3 TM study in m2 l min m2 Card D Aortic Valve Description SIGMA Sono Win Chapter End diastolic Aortic Root diameter AoD cm AOD mm Card M MV and Aorta Left Atrial end systolic diameter LAD cm LAD mm Card M MV and Aorta Aortic Valve Opening AVO AVD mm Card M MV and Aorta Left Ventricle Ejection Time LVET sec ET ms Card M MV and Aorta Left Ventricle Pre Ejection Period LVPEP sec PEP ms Card M MV and Aorta Ratio Left Atrial Aortic Root Diameter LAD AoD LA AO Card M MV and Aorta 7 98 SIGMA 110 SIGMA 330 15 10 01 Description Sono Win Chapter Ratio Pre Ejection Period Ejection Time Ae PEP ET Card M MV and Aorta K 2 3 4 Effective Opening Area Description SIGMA Sono Win Chapter Left Ventricle Output Trunk Diameter LVOTD LVOT Card D Aortic Valve Area computed from Dlvot LVOTA LVOT AREA Card D Aortic Valve Velocity Time Integral at Left Ventricle Out put Trunk VTIlvot VTIH Card D Aortic Valve Velocity Time Integral at Aortic Valve VTlao VTI2 Card D Aortic Valve Effective Opening Area of the Aortic Valve EOA AREA VTI12 Card D Aortic Valve Velocity at Aortic Valve Vao V1 Card D Aortic Valve Velocity at Left Ventricle Output Trunk Vlvot V2 Ca
334. troke volume index computed on aortic valve sv AVOTSV_SV Stroke volume computed on left ventricle output trunk AVSPSV_SV Stroke volume computed on aortic valve OGSPPIC Enddiastolic velocity cerebral medial artery computed Venddiast_ACM OGSPRIC_VelD Enddiastolic velocity cerebral medial artery computed on RI OGSPPIU VelD Enddiastolic velocity umbilical artery computed on Venddiast AUM OGSPRIU VelD Enddiastolic velocity umbilical artery computed on RI OGSPPIL VelD Enddiastolic velocity uterine artery left computed on PI Venddiast OGSPRIL Enddiastolic velocity uterine artery left computed on RI OGSPPIR VelD Enddiastolic velocity uterine artery right computed on PI Venddiast AUT r OGSPRIR VelD Enddiastolic velocity uterine artery right computed on RI MVCE_Vel1 Velocity from mitral valve continuity equation ea MVPHT PKV Max velocity from mitral valve PHT ANCEQ Vel1 Velocity 1 from vascular continuity equation VpeakS1 ANPI_Vels Max Velocity from vascular ANCEQ_Vel2 Velocity 2 from vascular continuity equation VpeakS2 ANRI_Vels Max Velocity from vascular RI OGSPPIC_Vels Systolic velocity cerebri media artery computed on sys ia OGSPRIC Vels Systolic velocity cerebri media artery computed on RI OGSPPIU Vels Systolic velocity umbilical artery computed on PI Vsyst AUM OGSPRIU Vels Systolic velocity umbilical artery computed
335. trument OFF press the power ON OFF key on the keyboard The Power OFF Menu is displayed Power Cancel Off e Press POWER OFF F1 to confirm the current switching OFF sequence e Press CANCEL to abort the current switching OFF sequence This switching OFF sequence is designed to avoid switching OFF by mistake After the POWER OFF confirmation the power indicator blinks and the instrument is in stand by mode With the remote control the machine can be powered off immediately if the user presses the POWER OFF button Press the power switch on the rear to completely switch the machine OFF Note When the instrument is not used for 10 minutes the image automatically goes into frozen state Then most function keys become inactive A beep warns the user Press FREEZE key to return to previous mode 3 3 2 Switching OFF SIGMA 330 Excellence To switch the instrument OFF press the power ON OFF key on the keyboard The Power OFF Menu is displayed Power Cancel Off e Press POWER OFF F1 to confirm the current switching OFF sequence e Press CANCEL to abort the current switching OFF sequence This switching OFF sequence is designed to avoid switching OFF by mistake e Select Shut Down on the PC dialog e The system is automatically powered off After the POWER OFF confirmation the power indicator blinks and the instrument is in stand by mode Press the power switch on the rear to completely switch the machine OFF 3 6 SIGMA 110 SIG
336. ts per minute 7 24 SIGMA 110 SIGMA 330 15 10 01 Cardiac Output Index in litres per minute Cl CO ID 5 Cardiac Output in litres per minute BSA Body Surface Area in square meters Stroke Volume in millimetres SV SVD area p VTI 2 m D area p D 1 VTI Velocity Time Integral D Diameter of vessel in centimetres Stroke Index Volume in millilitres per square metres 51 SID SV BSA SV Stroke Volume in millilitres BSA Body Surface Area in square meters b Continuity equation Area in cm2 computed from LVOTD LVOTA 2 LvorA D LVOTD _ 4 LVOTD Left Ventricle Output Trunk Diameter in cm Effective Opening Area at Aortic Valve in cm2 computed from velocities EOA EOA D LVOTA Vlvot Vao Velocity at Left Ventricle Output Trunk in m s Vlvot Velocity at Aortic Valve in m s Vao EOA at Aortic Valve in cm2 computed from velocities time integral EOA D VTIlvot EOA VTlao Velocity Time Integral at Left Ventricle Output Trunk in cm VTIIvot Velocity Time Integral at Aortic Valve in cm VTlao 15 10 01 APPENDICES 7 25 H 4 KONTRON MEDICAL D 4 Right Ventricle Study D 4 1 Description 14 01 98 08 30 31 LAB ODE Ri RTI
337. ufacturer After this operation the user must verify the format of its SRAM on the PC and on the SIGMA If the SRAM is no more formatted the user must format it again on the SIGMA 3 58 SIGMA 110 SIGMA 330 10 12 01 3 12 Annotations The ANNOTATE key displays the ANNOTATION Menu This menu is used to write annotation labels or arrows on the screen 2 Clear cee carat User1 User2 29 List Medical page 2 User3 User4 Del List Clear carat Note Menu items links to F1 F2 F6 and F7 keys contains the reference to lists defined by the user In this document these 4 lists are called User1 User2 User3 and User4 These four fields are empty when they contains no reference to a list e g first use of the sigma 3 12 1 Entering Annotation Mode i Annotation Menu According to the last selected page of this menu the first or the second page is displayed 3 12 2 Exiting the Annotation Mode E Loro x X Freeze 10 12 01 OPERATING INSTRUCTIONS 3 59 3 12 3 Manual Text Annotation When the user enters the annotation menu the manual text entry mode is selected by default if the page which contains this menu item is displayed To activate it after an arrow annotation for instance press on the Text key To write text on screen the user puts t
338. up MO neta Gulia lan uia ses 3 13 26 2 Loading a Setup o las 3 13 3 6 3 Saving a Setup Sa ie t ir M cee 3 13 3 004 Deleting Selilp un copie coe eR eS 3 14 GRE 4 1 1 141651 APPLET DEN 3 14 3 6 6 PCMCIA CARD iiie ee tatit i Et E 3 23 Ii nora 3 23 9 77 Major etra tb asa ope b n opaca i rio rit Vias ior 3 25 Sut SAD MOG Gara teo tie MM pitt uiu 3 25 38 7 2 TM Time Motion uendere eed 3 31 37 3 S Bossi ert E 3 34 374 OW DODDIBE PERRO 3 39 3 5 ous 266 ev Ee t 3 42 Mtn t E RE 3 46 OB PEIUS sb Mad Rob dI UAM CUN Da MA OU Ud 3 47 2 9 ING MOUG Be 3 48 8 9 1 Storing PIClUfes s oce b edt eden obe tdt ui Lis tton 3 48 10 12 01 TABLE OF CONTENTS ix MEDICAL 3 9 2 jDisplayinig PICIUFGS eee eee oir atten da 3 49 2 9053 Gine Auto Replay sisisi t e D ee renee arene REN ROR 3 49 3 10 Magnifier in 2D 2 tob ese ER Ea tO 3 50 3 11 Digital Archiving pub obe
339. uted from simplified Bernouilli equation V Velocity in m s Mean Gradient in mmHg MnG MnG D ut Time PTI Pressure Time Integral Time Duration flow in seconds Pressure Half Time in millisecond PHT PHT DPV Q 42 S PV Peak Velocity in metres per millisecond S Slope in metres per square seconds Mitral Valve Area in cm2 EOA computed from PHT 220 EOA D Pressure Half Time in milliseconds Cardiac Output in litres per minute CO D SV HR 1000 SV Stroke Volume in millilitres HR Heart Rate in beats per minute Cardiac Output Index in litres per minute per square meters CO ID S BSA CO Cardiac Output in litres per minute BSA Body Surface Area in square meters 7 20 SIGMA 110 SIGMA 330 15 10 01 e Stroke Volume in millilitres SV SV DMVA VTI 2 MVD 4 Velocity Time Integral MVD Mitral Valve Diameter in cm e Stroke Index Volume in millilitres per square metres SI SV I D gt gt 2 BSA SV Stroke Volume in millilitres BSA Body Surface Area in square meters b Continuity equation Area cm2 computed from SAD SAA SAA p SAD 4 SAD Sub Aortic Diameter in cm Mitral Valve EOA cm2 computed from velocities time integral EAO FAO D SAA VTIsa VTImv VTIsa Sub Aortic Velocity Time Integral in cm VTImv Mitral Valve Velocity Time Integral in cm 15 10 01 APPENDICES 7 21 H 4 KONTRON MEDICA
340. w direction cursor on the line marker The angle is adjustable from 70 to 70 degrees The velocity scale is automatically changed according to the angle Energy This parameter depends on operating probe and its dedicated applications It is stored in the Factory Setup When selecting Energy the associated MP potentiometer allows the user to reduce the transmit energy 0 3 6 9 12 15 18 21 dB attenuation 0 dB cor responds to maximum energy which is smaller or equal to the recommended level for the selected application see Chapter 1 7 12 Acoustic Power on page 1 51 Steer This function is available when Linear Probe is selected It allows the user to choose the steering angle of the Doppler beam no steering left steering right steering The steering angle depends on the selected probe and the emitted frequency Gamma When selecting Gamma the associated MP potentiometer selects different compression curves which perform a compression of spectrum gray levels on the screen Q Max Mean Max Mean SIGMA 110 and SIGMA 330 can calculate mean and max velocities and display the corre sponding curves on Doppler spectrum This button functions in a circular manner Off no trace display Max display of Vmax and Vmax curves in orange on Doppler spectrum Mean display of Vmean curve blue on Doppler spectrum Max Mean display of Vmax and Vmax curves in orange Vmean curve in blue simultaneous
341. weeks 1 EBD weeks A EBD weeks G 10 3 1 Source Lai G S H Yeo Reference Charts of foetal biometry in Asian Singapore Med J 1995 Vol 36 628 636 7 80 SIGMA 110 SIGMA 330 15 10 01 G 11 Head Circumference G 11 1 HC from Hadlock 2 3 from Hadlock EBD week week EBD week HC cm G 11 1 1 Source Hadlock R L Deter Harrist S K Park Fetal Head Circumference Relation to Menstrual Age Am J Roentgenology 138 649 1982 15 10 01 APPENDICES 7 81 AVA KONTRON MEDICAL G 11 2 HC from Merz HC from Merz EBD week week 4 EBD week 20 HC cm G 11 2 1 Source Ultrasound in Gynaecology and Obstetrics Textbook and Atlas Thieme Medi cal Publishers Inc New York 1991 7 82 SIGMA 110 SIGMA 330 15 10 01 G 11 3 HC from Lai Yeo HC cm EBD week 9 7 14 8 0 8 16 7 20 0 0 9 20 3 23 0 1 1 22 5 25 0 1 1 25 5 28 0 1 3 27 3 30 0 1 6 28 1 31 0 1 7 30 2 34 0 2 2 30 8 35 0 2 5 31 8 37 0 4 0 HC from Lai Yeo EBD weeks 1 EBD weeks EBD weeks 5 0 4 0 0 T T T T T T 1 0 0 5 0 10 0 15 0 20 0 25 0 30 0 35 0 HC cm G 11 3 1 Source F M Lai G S H Yeo Reference Charts of foetal biometry in Asian Singapore Med J 1995 Vol 3
342. ws cool 1 LLL Ll l 3AE JEZIEZJE To delete an arrow select Clear Arrow 3 64 SIGMA 110 SIGMA 330 10 12 01 3 13 Body Markers A set of body markers is available for each medical application The body markers are used to annotate the ultrasound image They show the examined part of the body The orientation marker shows the scan plane For Cardiology there is no orientation marker the body marker shows the plane itself The body markers are accessible from the main ANNOTATION Menu and FREEZE Menu 3 13 1 Displaying Body markers To display the body markers 1 Press the Body Marker key to display the Body Marker Menu essen Mecica e 2 Select the desired BODY MARKER in the scrolling list using the trackball then press Da Upper SET key The Body Marker is displayed the bottom right corner of the selected image To scroll the body marker list the user puts the focus rectangle on the scrolling Up or Down arrow When the focus rectangle is on the scrolling Up Down Arrow the list is automati cally scrolling up down in order to select other available body markers scrolling Up Arrow Focus rectangle e S a HEL 4 scrolling Down Arrow 3 Use the Trackball to move the scan direction marker and or Use MP potentiometer to modify the orient
343. y Transducer S H F T 256 levels grey scale Ergonomic design for optimal user comfort E D O PW CW spectral Doppler Option Up to 282 images cine loop Option KIPRISM digital storage Remote Control Option SIGMA 110 SIGMA 330 15 10 01 1 2 SIGMA 110 330 Equipments The table below shows the composition of the SIGMA 110 SIGMA 330 family Name Relationship SIGMA 110 Light SIGMA 110 accepting Annular Sector probes only SIGMA 110 Master SIGMA 110 accepting Annular Sector probes and Linear Convex probes SIGMA 330 Master SIGMA 330 including colour monitor and Iris features SIGMA 330 Expert SIGMA 330 Master with integrated cart and dual port for Linear Con vex probes SIGMA 330 Excellence without Frame Grabber SIGMA 330 Expert with Colour Doppler CFM and extended capabili ties Picture Archiving and Communication System etc SIGMA 330 Excellence with Frame Grabber SIGMA 330 Expert with Colour Doppler CFM and extended capabili ties 3D Picture Archiving and Communication System etc Table 1 1 SIGMA 110 330 family The SIGMA 110 330 systems are available in different language versions The following table lists the ordering reference numbers of the SIGMA 110 SIGMA 330 models References Models English French German Italian Spanish Cyrillic SIGMA 110 Light 480 770 483 788 483 966 484 121 484 318 484 482 SIGMA 110 Master 482 110
344. ys if the preference doted line has been selected in the set up preference menu The doted line disappears if the preference no doted line has been selected in the set up preference menu During the measurement the user can delete a part of the current measurement by pressing on the BACKSPACE key 1 0 0 8 0 6 0 4 02 e sxs 4 02 e 04 GN 655 v Op 06 0 8 10 Freq VTl Time HeartRt PI amp RI RI PHT Ratio undo The result of the Speed Gradient measurement depends on the current SP scale and is dis played in centimetres per seconds if the maximal scale velocity is in centimetres per seconds or in meters per second on the right side of the screen 10 12 01 OPERATING INSTRUCTIONS 3 83 AVA KONTRON MEDICAL 3 14 6 2 Frequency Measurement The frequency measurement is made like the Speed Gradient measurement but the result is displayed in kHz 1 Press F2 Freq to select frequency measurement 2 Use the trackball to move the marker to the desired position 3 Press upper left SET key to fix the marker The result is automatically displayed on the screen The doted line stays if the preference doted line has been selected in the set up preference menu The doted line disappears if the preference no doted line has been selected in the set up preference menu During the measurement the user can delete a part of the current measurement
345. ystem continuously checks the probe high voltage in all modes except in CFM while the probe voltage continuously changes from the 2D voltage to the Doppler voltage When the Probe high voltage is outside the limits the high voltage warning icon is displayed on screen 5 7 E Date amp Time General information and Patient name Technical data Grey scale Meas result Zoom indicator ECG message a Mag Mark icon The first time the problem occurs the BWarning 24 Transmit Voltage is not under controlbis dis played see page 5 16 5 8 SIGMA 110 SIGMA 330 15 10 01 5 Warnings 5 41 Startup checks 5 4 1 1 Transducer Check At system start up or for each transducer change the current plugged transducers codes are checked according to the current recognised transducers list P 2 P 3 Invalid Invalid P 6 3 5GP 7 5GP Probe Probe 3 5CV If one of the plugged transducer is not included in this list on the probe menu Invalid Probe is displayed instead of the current probe name or the transducer name is displayed in grey Transducer name is displayed in grey when the user wants to use a pencil probe without a Doppler board e a PEN 2 MHz transducer is plugged without the Cardio option Invalid Probe can be displayed if the current probe is not recognised by the sy

- Frank`s Hospital Workshop

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