Home

USER MANUAL Version 2.02

1. 53 14 3 2 Sel ction M 53 RE ER EE 53 14 3 4 Rename Contextual menu 54 EEE EXBOFL adottata D tte RE end eie eset uice f i 54 14 3 6 Delete Contextudl menu ere rt deste Rare o Ee EROS EE SERE t etes EA EAR 54 15 MEASURES KEY NUMBER 19 ccsssssssssscessccsscssssssscessccascessssaccesacesscessssascesssesscnssstaccusaceascussssascossseascussusace 55 15 1 MEASURES IN B CFM AND ANATOMIC M MODES nnnnnnesnneeeseeeresereesreensesereseneseresenesereeeneseneseneseresenesenerereerneenne 55 15 1 1 Distance Contextual men rsen Reese Ete ERE TE PEE a bu REN Geo Ee CASU FEE NU te dot gites 55 15 1 2 aI Teler cce T lt T T iii iii 55 15 1 3 Trace Contextual E 55 15 1 4 Measures in B Dual Mode eei VEER tec s te Eee a boda ae pe dead uade Lato a e d eoe E aaaeei RE 56 15 1 4 1 Volume Contextual menu 56 15 1 5 Arrow Contextual menu 56 15 1 6 Annotation Contextual menu 56 15 1 7 Select Contextual menu sisi einen tetes EC D sues e open ave it ele at 57 KDE UJ SL 57 15 1 9 Delete Contextual menu 57 15 1 10 Delete all Contextual menu 57 15 2 MEASURES IN OE Gele ee serere eR n re neant SEENEN ENEE deen SEC E ER VR SURE PE Re dE 57 15 2 1 Rate Cont xtual Men cei tcrtio eese decre aera eise e ERE Ee tetes te 57 15 2 2 Distance and time interval Contextual menu 57 15 2 3 Arrow Contextual MO
2. Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 101 sur 173 BECM Noveko Probe model E610R Mode B TIS TIB Index label MI Non scan e TIC can 2 2 on scan Aaprt lt icm Aaprt 1cm Maximum Index Value 0 87 0 34 a Pra MPa 2 19 P mW 12 a Min Palz lea mlzs Zs cm Zbp cm Associated acoustic 2b em parameters zau max loi cm 3 deql2p cm fawf MHz 6 29 6 29 a Dim apr 0 92 a Y 0 58 a ty us 0 27 prr Hz 64 Other information Dr at max lpi 4 20 deq at max lpi cm loa at max MI W cm 228 Probe model EG10R Mode CFM TIS TIB Index label MI Non scan TIC can 2 2 on scan Aaprt lt icm Aaprt 1cm Maximum Index Value 0 87 0 38 a Pra MPa 2 20 P mW 12 8 a Min Palz lea mlzs Zs cm Zpp cm Associated acoustic cm parameters z at max loi cm 3 degl2p cm fawf MHz 6 29 6 16 6 29 a Dim prt N 0 92 a Y 0 58 a ty us 0 27 prr Hz 18 9 Other information Dr at max loi 4 20 deq at max lpi cm La g 8t max MI W cm 230 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 102 sur 173 BECM Noveko Probe model E610R Mode PW TIS TIB Index label MI Non scan TIC can 2 2 on scan Aaprt
3. een 74 19 4 2 2 Without entering the TE 74 19 4 2 3 Obstetric Report mode GA is ber Eu selon ERU auo ioc e tentent tva M YER NESS 74 19 4 2 4 Multiple pregnancies Number of fetuses sise 74 19 4 3 Examination in Cordiolog sisi 75 19 5 ADDING ELEMENTS TO THE REPORT eres etes rete ere heo Ene ean en REN eee Ee PERENNE EUR RAP UMANE CREE FEE ERE PRAES EE Ee ERR RAN RT vR E ege 75 19 6 STOP AN EXAMINATION ee SEN Race ea EEN EEN Sede RE deus 75 20 REPORT KEY NUMBER 32 sesscssssscscocsssssctsssssssessteavescensasssesveacusscbsasessiveccvsssnsacesesvsosessacsasesnassesscsoesocenaaee 76 20 1 DISPLAY OF REPORT 5 551 eS ERIS RE RT cas ERR TEUER FER ERE TRA ERU EXER ERES SERERE RENE PE MERE ERE SEES ERR ES FERRE ER ERES E PERRO R ERE PER ORE cele 20 1 1 List display of Report 20 1 1 1 List display of a report in Obstetrics sisi 76 20 1 2 Text display of Report EE 76 20 1 2 1 Text display of a report in Obstetrics eee 76 20 13 te e 77 20 14 Graph 77 2071 5 Print scettr iva otii RT AT A A E rien rien A RE AR 77 GEET E 77 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 7 sur 173 BECM Noveko 21 CONNECTION OF PERIPHERALS ccccsssssssssssssscssscsscesccescesstesscssscsssccecsensscnsscnsecesecssesssesseesseessens 78 21 1 MANAGEMENT OF OUT PUTS VIDEO OUT USB DV see 78 21 2 PRINTING OF REPORTS ON USB CONNECTED THERMAL PRINTERS ccce he
4. LZ L JOUE E gj 636 6JEJEJ C J SS 38 36363 3 0363 3 63 amp JAN E JEJEJEJEJ JE ool 383 3 3G3 ES Ongo See the explanation of each key below Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 25 26 Page 22 sur 173 BECM Noveko 5 1 1 Keyboard explanation Number Key Description Chapter 1 Track ball Selection adjustment and moving of objects on the screen Selection of objects on the screen and validation of system controls 2 Select When right and left Select button have different functions the right button selects and blocks or goes from one marker to another and the left button validates 3 Freeze Freezing and de freezing of the image 13 4 B Activation of the B Mode by pressing Adjustment of the general B gain by 6 turning Display of the contextual B menu 5 CFM Activation and deactivation of the CFM mode by pressing Adjustment of the 8 CFM gain by turning Display of the contextual CFM menu Adjustment of opacity in 4D mode by turning 12 6 PW Activation and deactivation of the Pulsed Wave mode by pressing Adjustment 9 of the PW gain by turning Display of the contextual PW menu Activation of Continuous Wave mode when ticked on the Settings page 11 Adjustment of CW gain by turning Display of the contextual CW menu Adjustm
5. 594 5 H BE 384 8 LE 59 BE 388 8s T BE 79 59 T Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 138 sur 173 BECM Noveko THD Hansmann Identical Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 139 sur 173 BECM Noveko Fetal Ao RI Schaffer FG Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 140 sur 173 BECM Noveko Fetal Ao PI Schaffer FG z 34 1 35 37 1 38 1 39 e AB 1 42 A m 1 45 A2 1 48 1 52 1 53 1 57 1 61 D u Ln in 1 1 1 a o X G w 165 1 70 1 72 MCA RI Mai FG ololo o SININ M GG ui a o o o olola Ni cof 0 o o o a MCA RI Schaffer FG Version 3 du 16 07 2012 o oo R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 141 sur 173 BECM Noveko MCA PI Mai FG m w p N 1 3 n io o o ec Kai ai Kal Ui Ui u l mlm um Ka w Sol ot o Ui bi Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 142 sur 173 BECM Noveko Umb A RI Schaffer FG Umb A PI Mai FG Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 143 sur 173 BECM Noveko Umb A PI Schaffer FG Left Uterin RI Schaffer FG Version 3 du 16 07 2012 R f CD MA
6. Imagyne written on the right of the image indicates that the image is frozen When the image is frozen the Cineloop window appears in the right bottom corner of the screen The number of images and the length in seconds of the frozen sequence are indicated in the window The length of the sequence depends on the imaging mode and the frame rate A yellow triangle in the Cineloop window indicates the start of the sequence and a green triangle indicates the end of the sequence These triangles can be moved with the trackball in order to reduce the length of the sequence for storing See chapter 14 2 on this issue By default the curser is trapped by the play indicator in the Cineloop window It can be moved by the trackball to the left to go backwards in the sequence and to the right to forward it The curser is unleashed from the Cineloop window by clicking Select To put the curser back in the Cineloop window click on the play indicator in the window The cineloop can be activated and paused with the key Cineloop Key number 23 The sequence is played forwards The cineloop sequence can be played backwards image by image by the key lt and forwards image by image by the key gt The controls Store image Key number 22 and Store clip Key number 21 are active in freeze mode and enable to store the wanted content on the hard disk of the device See chapter 14 for details about storing In Freeze mode all post processing functions a
7. Left Humeral Artery Left Humeral Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Right Humeral Artery Right Humeral Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Left Brachial Artery Version 3 du 16 07 2012 Left Brachial Artery R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Page 168 sur 173 BECM Noveko APPLICATION VASCULAR Mode PW Abbreviation Organ Measure tool Manual Acceleration Acceleration Right Brachial Artery Right Brachial Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Left Ulnar Artery Right Ulnar Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Right Ulnar Artery Right Ulnar Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Left Radial Artery Left
8. Manual Acceleration Acceleration Pulmonary valve Doppler Auto Doppler manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Mitral valve Doppler Auto Doppler manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Tricuspid valve Doppler Auto Doppler manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Doppler Auto RI PI Speed Systole Speed Diastole S D Doppler Manual RI Speed Systole Speed Diastole S D Doppler Manual Trace Systole Diastole RI PI S D Heart Rate Rate Time Time Speed Speed Flow Flow VAVG Diameter Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 154 sur 173 BECM Noveko Surface Manual acceleration Acceleration time Acceleration Acceleration Acceleration Time Acceleration APPLICATION CARDIOLOGY Mode CW Organ Measure tool Result Body Surface Area Area Time Time Speed Speed Manual acceleration Acceleration time Acceleration Aortic valve Time Speed Manual Acceleration Acceleration time Acceleration Pulmonary valve Time Spe
9. Warning When adjusting the height of the keyboard take care of avoiding pinching your fingers between the screen arm and the upper part of the equipment Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 19 sur 173 BECM Noveko 4 Getting started 4 1 Connection and disconnection of probes To connect a probe put the probe connector in the opening provided for this purpose on the front of the device with the cable pointing downwards Turn the locker situated in the middle of the connector with a slight pressure in order to engage the locking mechanism When the locking mechanism is engaged make a quarter turn clockwards so that the probe is connected After connecting a probe always place the probe in one of the probe holders placed on the device in order to avoid any damage of the probe due to a shock or falling down The probes can be changed duirng the examinaton without restarting the device To disconnect a probe make a quarter turn counter clockwards in order to unlock the connector Take the connector out of the device and store the probe in an appropriate place protected from shocks Warning Before disconnecting the active probe make sure to freeze the image When starting the device always make sure to have a probe connected on the first connector Probe 1 The connected probes are indicated in the right bottom of the screen The currently active probe is highlighted The volumet
10. Left DP Artery Left Dorsalis Pedis Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Right DP Artery Right Dorsalis Pedis Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Left SFA Artery Left Superficial Femoral Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Right SFA Artery Right Superficial Femoral Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Left AT Artery Left Anterior Tibial Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Right AT Artery Right Anterior Tibial Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 171 sur 173 BECM Noveko APPLICATION VASCULAR Mode PW Abbreviation Organ Measure tool Manual Acceleration Acceleration Left PT Artery Left Pos
11. Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 76 sur 173 BECM Noveko To return to the text visualization click on the same window now named Text 20 1 3 Images Click on Images in the middle left of the screen to display the images stored during an examination in Multiview Tick the corresponding box for each image which should be printed in the report After selection only the selected images are displayed when in Text display of the Report Exit of Multiview of images by clicking on the cross in the lower right corner 20 1 4 Graphs Click on Graphs in the middle left of the screen to display the graphs stored during an examination in Multiview Tick the corresponding box for each graph which should be printed in the report After selection only the selected graphs are displayed when in Text display of the Report Exit of Multiview of graphs by clicking on the cross in the lower right corner 20 1 5 Print Click Print Preview to see how the report will be printed If you want to print the report on a video out connected thermal printer press Print on the printer itself when in Print Preview Repeat this for each displayed page of the report Click Print for printing the report on a USB connected thermal printer or on a PC printer See chapter 5 4 about printer installation and chapter 21 2 about printing of reports on USB connected thermal printers 20 1 6 Delete A measurement can be deleted by cli
12. Warning Do not bend or twist the transducer cable If the transducer housing becomes cracked or broken or if there are cuts or openings in the cable the electrical safety features of the transducer might be compromised gt Warning Do not immerse the transducer connector in any liquid Immersing it can destroy its electrical safety features 2 8 4 Ultrasound coupling gel Some ultrasound coupling gels and lotions can damage the probes Agents containing the following chemicals are known to damage transducers Acetone Methanol Denatured ethyl alcohol Mineral oil N lodine Any lotion or gel that contains perfume Warning Check the gel contents with your gel supplier Warning To avoid any problems regarding the use of ultrasound coupling gel please respect the following rules e Always check the expiry date on the gel bottle prior to use on a patient Always throw expired bottles away e Choose 250ml conditioning rather than 5 liters Never use a 5 liters bottle to fill smaller bottles each day e Throw away all started bottles at the end of the day e Before the probe disinfection procedure between each examination wipe off all gel residues on probe head housing and cable Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 17 sur 173 BECM Noveko Warning Neither the ultrasound coupling gel nor the external probes are intended for use on a damaged skin 2 8 5 Surface temperat
13. according to each application Exit of the menu by pressing again 19 Measure Freezing of the image and possibility to make measurements on the frozen 15 image or sequence of images Display of the contextual measure menu Return to the frozen sequence of images by pressing once again 20 Review Management of stored images and sequences of images review export 14 rename delete Display of the contextual Review menu Exit of Review by pressing once again 21 Store clip Storage of a sequence of frozen images 14 22 Store image Storage of a frozen image 14 23 Cineloop Activation and pausing of the reading of the last saved sequence of images 13 lt Playing the sequence backwards image by image gt Playing the sequence forwards image by image Rocker 6 4 24 g Adjustment of the TGC gain switches 25 Contextual Selection activation and deactivation of contextual menus according to each keys imaging mode and function 26 Alphanumeric Entering of text and numbers 27 Probe 1 2 3 Changing of probes 4 1 28 4D Activation of the 4D imaging mode by pressing 12 29 Harmonic Activation and deactivation of the Pulse Inverse Harmonic function 6 21 30 M Activation and deactivation of the M mode 7 31 Patient Access to Patient files Exit of Patient menu 19 32 Report Access to the on going examination report when a patient file is open 20 Access to the list of applications and presets Display of the contextual Preset 17 33 Preset menu E
14. 136 3 149 3 16 174 4 186 5 N N Age Stil o eo LR NEC HN 8 aa e 1 o o o 98 Lu met ep rj KEE cl E LR Run a o es EI ONENN o e 299 7 7 299 a L E RG EN xm xj RSC RE e vj E ae I n E po 8 a LR 390 es pao RE o mem po pe a o SE E m D 9 wm v EE 4 9 580 ee z al Lee es Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 133 sur 173 BECM Noveko HC Chitty Pltd FG eo ee ee cj ocu E Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 134 sur 173 BECM Noveko HC Hadlock FG HC Hansmann Identical weeksidays mm Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 135 sur 173 BECM Noveko OFD Chitty FG Sim n S E388 3 8s s9 me 8 H Ln E398 594 LE 39 H Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 136 sur 173 BECM Noveko OFD Hansmann Identical weiss Sn m ss n 9 EC ERR ECH R ES S Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 137 sur 173 BECM Noveko TAD CFEF FG Me xem Et T Se RER 198 8 H BE 5 8 9 H BE 582 9 dE n BE
15. 6 14 3 Grain Ima Clean contextual submenu Adjustment of the granularity of the image by the keys Grain and Grain 6 14 4 Line Ima Clean contextual submenu Adjustment of the enhancement of continuous line structures 6 14 5 Reset Ima Clean contextual submenu Return to the initial Ima Clean adjustments saved in the current preset 6 15 Anatomic M Contextual menu Activation of the mode Anatomic M by pressing the key Anatomic M in the contextual B menu A curser is displayed on the B picture Drag it with the trackball to the selected position press Left Select to validate the position of the first curser Drag the trackball to the selected position of the second curser displayed with an arrow Click Right Select to switch from one curser to another for adjusting Click Left Select to validate the positions After validating the anatomic M is displayed in the lower part of the B image 6 16 Ima Level Contextual menu Noise rejection on the whole B image by the keys Ima Level When the function is active the key is highlighted in red Adjustment of the Ima Level 5 steps with the arrow keys on the alphanumeric keyboard 6 17 Gamma Contextual menu Adjustment of the gamma curve by the keys Gamma and Gamma in the contextual B menu The updated Gamma scale is displayed on the right of the screen 6 18 Extra B tools Contextual menu Access to the sub menu of extra B tools by the key Extra B tools in the contextual B menu Exit of t
16. Activation and adjustment of the trapezoidal image by the keys Trapezoidal and Trapezoidal in the Display Size contextual sub menu The updated trapezoidal angle is displayed on the right of the screen Maximum angle 50 The trapezoidal function is only available on the linear probe 6 20 ECG Contextual menu Access to the ECG sub menu by the key Menu ECG in the contextual B menu Exit of the sub menu by pressing the key Exit 6 20 1 ECG ECG sub menu Connect the ECG cables before activating the ECG function Activation of the ECG curve by pressing the key ECG When this function is active the key is highlighted in red The ECG curve is displayed on the bottom of the image The ECG function is active in the following modes B CFM PW and CW To deactivate the ECG press the ECG key again 6 20 2 ECG time ECG sub menu Adjustment of the ECG time scale with the keys ECG Time and ECG Time in the contextual ECG sub menu 6 20 3 ECG Smoothing ECG sub menu Smoothening of the ECG curve with keys ECG Smooting and ECG Smoothing in the contextual ECG sub menu To deactivate the ECG press the ECG key again Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 35 sur 173 BECM Noveko 6 21 Harmonic Key number 29 Press the key Harmonic Key number 29 to activate the function Pulse Inversion Harmonic PIH This function consists in emitting the ultrasounds at one frequency fundamental frequency
17. Doppler Manual RI Speed Systole Speed Diastole S D Doppler Manual Trace Systole Diastole RI PI S D Heart Rate Rate Acceleration Acceleration Time Acceleration APPLICATION GENERAL Mode M Measure tool Measurement Result Stenosis Distance ID Ratio Distance ED Distance y Ratio Distance A A B Distance B Time and Distance Time and Distance Distance Time D T Heart Rate Rate Rate Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 149 sur 173 BECM Noveko APPLICATION ABDOMINAL Mode B CFM Organ Measurement Spleen Dist A Dist B Left Kidney Width Height Right Kidney Width Height Pancreas Head Body Tail Duct Gall Bladder Width Height Wall T Liver Width Height Prostate Width Height Depth Thyroid Width Height Depth Aorta Diameter Diameter Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 150 sur 173 BECM Noveko APPLICATION ABDOMINAL Mode PW Organ Measure tool Left Renal Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Acceleration Right Renal Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Acceleration Hepatic Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Acceleration
18. ED 2 chambers EDV ES 2 chambers ESV ED 4 chambers Stroke volume ES 4 chambers Cardiac output Ejection fraction Cardiac area length Diastole Volume EDV Systole Volume ESV Stroke volume Cardiac output Ejection fraction Teichholz Cross Section Diastole EDV Systole ESV RV Diameter Stroke volume Cardiac output Ejection fraction Cube Cross section Diastole EDV Systole ESV RV Diameter Stroke volume Cardiac output Ejection fraction Gibson Cross Section Systole EDV Diastole ESV RV Diameter Stroke volume Cardiac output Ejection fraction Bullet Method Diastole LVL EDV Systole LVL ESV Diastole LVAM Stroke volume Systole LVAM Cardiac output Ejection fraction Biplane Method Diastole LVAL EDV Systole LVAL ESV Diastole LVAM ID Stroke volume Systole LVAM ID Cardiac output Ejection fraction Body Surface Area Area Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 153 sur 173 BECM Noveko APPLICATION CARDIOLOGY Mode PW Organ Measure tool Result Heart Rate Rate Body Surface Area Area Time Time Speed Speed Manual acceleration Acceleration time Acceleration Aortic valve Doppler Auto Doppler manual Doppler Manual Trace Heart Rate Time Speed Flow
19. Left Uterin PI Left Uterin RI Right Uterin PI mn H Schaffer IPDS 1998 11th Congress of the International Perinatal Doppler Society mn haffer JOU FUR FERTILTAT UND REPRODUKTION July 2 4 1998 M M Sc H Schaffer IPDS 1998 11th Congress of the International Perinatal Doppler Society Schaffer JOU FUR FERTILTAT UND REPRODUKTION July 2 4 1998 H Schaffer IPDS 1998 11th Congress of the International Perinatal Doppler Society Schaffer JOU FUR FERTILTAT UND REPRODUKTION July 2 4 1998 C Sc M ai ai H Schaffer IPDS 1998 11th Congress of the International Perinatal Doppler Society Schaffer JOU FUR FERTILTAT UND REPRODUKTION July 2 4 1998 H Schaffer IPDS 1998 11th Congress of the International Perinatal Doppler Society haffer JOURNAL FUR FERTILTAT UND REPRODUKTION July 2 4 1998 R Mai P Kristen A Rempen Farb Dopplersonographisme Normalwerte in der Schwangershaft Z ai Geburish u Perinat P 221 222 ai Right Uterin RI mn e H Schaffer IPDS 1998 11th Congress of the International Perinatal Doppler Society Schaffer JOURNAL F R FERTILTAT UND REPRODUKTION July 2 4 1998 R Mai P Kristen A Rempen Farb Dopplersonographisme Normalwerte in der Schwangershaft Z M Geburish u Perinat P 221 222 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 112 sur 173 e n BECM Noveko H
20. Portal Vein Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Acceleration Aorta Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Acceleration Doppler Auto RI PI Speed Systole Speed Diastole S D Doppler Manual Trace RI PI Speed Systole Speed Diastole S D Doppler Manual RI Speed Systole Speed Diastole S D Heart Rate Rate Acceleration Acceleration Time Acceleration APPLICATION ABDOMINAL Mode M Organ Measurement Left Renal Artery Heart Rate Right Renal Artery Heart Rate Hepatic Artery Heart Rate Portal Vein Heart Rate Aorta Heart Rate Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 151 sur 173 BECM Noveko APPLICATION ANESTHESIA Mode B CFM Measure tool Measurement Result Distance Distance Distance Ellipse Ellipse Circumference Surface Trace Circumference Surface Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 152 sur 173 BECM Noveko APPLICATION CARDIOLOGY Mode B CFM Measure tool Measurement Result Simpson Diastole Volume EDV Systole Volume ESV Stroke volume Cardiac output Ejection fraction Simpson 2 amp 4 chambers
21. Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 109 sur 173 BECM Noveko 27 Annex IV Tables references and calculations 27 1 List and bibliographic references of obstetrical tables e entm Abdominal Circumference Chitty L S Altman D G Charts of Fetal Size 3 Abdominal Measurements ter Bibliographic reference e Chitty drvd British Journal of Obstetrics amp Gynaecology jan 1994 vol 101 P 125 131 Chitty L S Altman D G Charts of Fetal Size 3 Abdominal Measurements Chitty Pltd British Journal of Obstetrics amp Gynaecology jan 1994 vol 101 P 125 131 Biometry 2000 Fetal growth charts by the Coll ge Francais d Echographie Foetale CFEF the French College of Fetal Ultrasonography and INSERM U 155 CFEF Gynecol Obstet Fertil 2000 Jun 28 6 435 45 Hadlock FP Deter RL Harrist RB Park SK Estimating fetal age Computer assisted analysis of multiple fetal growth parameters Hadlock Radiology 1984 152 497 502 Hansmann M Hackel er B Staudach A Ultrasound Diagnosis in Obstetrics and Gynecology Springer Verlag 1990 Jeanty ISBN 0 387 15348 9 Springer Verlag New York P 179 Norio Shinozuka Haruo Masuda Hideroni Kagawa Yuji Taketani Standard Values of Ultrasonographic Fetal Biometry Tokyo Jpn Med Ultrasonics Vol 23 No 12 1996 P 877 888 Merz E Ultrasound in Gynecology and Obstetrics Merz Stuttgart New York Thieme Medical Pub
22. Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 3 sur 173 BECM Noveko 9 7 ANGLE KEYNUMBER L2 surrer seese eree a eege genee d en 42 9 7 1 Automatic Angle correction EE 42 9 8 BASELINE KEY NUMBER 14 6 rir enter oer eost e o err eese reote buc eege sk eode de 42 9 9 INVERT CONTEXTUAL MENU eee e 42 9 If AUDIO KEY NUMBER 15 EE 42 9 11 IMA PULSE AUTOMATIC OPTIMIZATION OF PW SPECTRUM CONTEXTUAL MENU es eee ee nnne 42 9 12 HIGH PRF CONTEXTUAL MENU 42 9 13 SIMPLEX DUPLEX CONTEXTUAL MENU 43 9 14 NOISE REJECT CONTEXTUAL MENU 43 9 15 WALL FILTER CONTEXTUAL MENU c 4 c2525 c0 ccssecanvesssabcevacecnaeeeesaverdocssaaventocdsvaesoseauedaccderdessgsbvengeaarieencestecssauvels 43 9 16 TIME SCALE CONTEXTUAL MENU 43 9 17 COLOR GONTEXTUALIMENU is coss cerae ore rere tirer Peer er t pete a i oa aE A EE o er EE n ES 43 9 18 B MODE aein legc 43 10 B CFM PW MOBDE 44 10 1 PW MODE CONTROLS im Remigio ve eo a awe eo dit ner ter d e e AE 44 10 1 1 Invert Contextual ET ME 44 10 1 2 Steering Key n mbeF E EE 44 10 2 CEMEMIODE CONTROLS 53 5 na Paese eoe eite eet oie certet e et ts bue Obr e obe nones Pope eege eege Es 44 bn T esse Lee 44 10 4 SIMPLEX TRIPLEX CONTEXTUAL MENU 44 jiEod e Fiubtellcm 45 11 1 POSITIONING O
23. and Y The default angle is 10 Press the key Ima Cross to deactivate the function and return to standard B imaging NB This function is only available on the linear probe 6 10 Ima View Automatic image optimisation Contextual menu Automatic optimisation of the B picture by the key Ima View in the contextual B menu To return to the previous image adjustment press the key Clear Ima View in the contextual B menu 6 11 Biopsy Contextual menu Display of the 2 guide lines between which the biopsy needle passes gt Warning This biopsy needle guide is only valid if the operator uses the biopsy guide recommended by ECM and listed for each probe See chapter 2 8 gt Warning The user must check the right fastening of the biopsy guide on the probe to ensure secure guidance of the needle gt Warning On probes C360V and C360A check that the biopsy needle is situated at the same side as the orientation marker of the probe gt Warning On probe E610A check and confirm by clicking OK that the system will display a biopsy guideline dedicated to medical application 6 12 Dual Contextual menu Activation and deactivation of the B Dual mode one live image and one frozen image on the screen at the same time by the key Dual in the contextual B menu Changing from a live image on the left to a live image on the right by the key Dual Select in the contextual B menu The two displayed images in dual mode are using the
24. central frequency 3 5 MHz This external probe is used for the following applications General abdominal gynecology obstetrics vascular L738P Linear probe central frequency 7 5 MHz This external probe is used for the following applications General vascular pediatrics small parts breast testis etc C614P Micro convex probe central frequency 6 MHz This external probe is used for the following applications General vascular small parts pediatrics P320R Phased Array probe central frequency 2 5 MHz This external probe is used for the following applications General cardiology E610A Endo cavity probe central frequency 6 5MHz This probe is used through the rectum or through the vagina for the following applications General gynecology obstetrics urology Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 15 sur 173 BECM Noveko E610R Endo cavity probe central frequency 6 5MHz This probe is used through the rectum or through the vagina for the following applications General gynecology obstetrics urology 4DC540V Volumetric convex 4D probe central frequency 4 5 MHz This external probe is used for the following applications General abdominal gynecology obstetrics vascular The indicated applications can be examined in B M PW or CFM modes or in combined modes The cardiology application can be examined also in CW mode Warning Do not use the probe for any other ap
25. 13 Adjustment of the PRF Pulse Repetition Frequency scale in CW by the PW PRF rocker switch situated next to the PW knob Upwards activation increases the PRF downwards activation decreases the PRF The updated PRF value in Hz is displayed at the right of the screen and the PRF scale on the spectral illustration is updated 11 4 Baseline Key number 14 Raising and lowering of the base line of the CW PRF scale by the Baseline rocker switch Upwards activation raises the line downwards activation lowers the line The PRF scale is updated to the right of the CW frame 11 5 Audio Key number 15 Adjustment of the acoustic volume of the CW by the Audio rocker switch 11 6 Noise Reject Contextual menu Increase and decrease of the noise filter by the keys Noise Reject and Noise reject in the contextual CW menu The noise reject indicator is displayed at the right of the screen Min noise reject 1 Max noise reject 10 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 45 sur 173 BECM Noveko 11 7 Wall Filter Contextual menu Increase and decrease of the Wall filter filtering of low frequencies by the keys Wall Filter and Wall Filter in the contextual CW menu The velocities nearest to the baseline are filtered The filter indicator is updated on the right of the CW frame Min filter 1 Max filter 4 11 8 Time scale Contextual menu Increase and decrease of the CW spectrum s time
26. 3 TGC See chapter 6 4 Dynamic See chapter 6 7 Gamma See chapter 6 17 Extra B tools B Average Color See chapter 6 18 Ima Level See chapter 6 16 16 5 B CFM PW Mode In B CFM PW Triplex mode the following controls are available for post processing 16 5 1 PW controls Gain See chapter 9 3 Angle See chapter 9 7 Invert See chapter 10 1 1 Baseline See chapter 9 8 Noise Reject See chapter 9 14 Wall Filter See chapter 9 15 Color See chapter 9 17 16 5 2 CFM controls Gain See chapter 8 4 Reject See chapter 8 7 16 5 3 B controls Gain See chapter 6 3 TGC See chapter 6 4 Dynamic See chapter 6 7 Gamma See chapter 6 17 Extra B tools B Average Color See chapter 6 18 Ima Level See chapter 6 16 16 6 CW Mode In CW mode the following controls are available for post processing 16 6 1 CW controls Gain See chapter 11 2 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 63 sur 173 BECM Noveko Baseline See chapter 11 4 Noise Reject See chapter 11 6 Wall Filter See chapter 11 7 Color See chapter 11 10 Invert See chapter 11 9 16 6 2B controls Gain See chapter 6 3 TGC See chapter 6 4 Dynamic See chapter 6 7 Gamma See chapter 6 17 Extra B tools B Average Color See chapter 6 18 Ima Level See chapter 6 16 16 7 4D Mode In 4D mode the following controls are available for post processing 16 7 1 4D controls Rotate See chapter 12 2 9
27. 5 298 7 328 9 35 0 277 308 1 339 1 36 0 285 4 317 3 349 2 37 0 293 6 326 3 359 1 38 0 301 6 335 2 368 8 39 0 309 4 343 9 378 4 40 0 317 352 4 387 7 41 0 324 5 360 7 396 9 42 0 331 7 368 8 405 8 G Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 116 sur 173 BECM Noveko AC Hadlock FG me om 50 mm SD mm z CL 5 S ES S EE ae fs S AC Tokyo FG 95 mm 125 m Un o m Eme Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 117 sur 173 BECM Noveko APAD Merz FG Re 5 ou 50 l mm 95 mm 4 0 AXT Tokyo FG 5 cm 50 cm 9596 cm BE SE ERR EC Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 118 sur 173 BECM Noveko BPD Tokyo FG ee 5 mm 50 mm 95 mm 2 0 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 119 sur 173 BECM Noveko BPD CFEF FG Le CL esL T mem Sim E26 544 E 4 LE 59 x 98 83 L9 wu 8 e ME BE 98 59 LE 39 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 120 sur 173 BECM Noveko BPD Chitty O O FG Le ces Ee Sim E399 H RER E299 B LE 399 89 3 Lm Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3
28. 8 3 Handling of probes iii sien ettet nnns sies sn ee tern sn sense eerte rena nnne nns 17 2 8 4 Ultrasound coupling gel 17 2 8 5 Surface temperatures sese eee e eee 18 2 9 END OF PRODUCT LIFEOF THE DEVICE Eben e ERE ede RE UE EEO E E E gv dace o e EE 18 3 INSTALLATION OF THE EQUIPMENT scssccssssscsssssssscsscssssscssscacssscsnsescsecsncsaceacsscsassscseasencsasensessees 19 4 GETTING STARTED e 20 4 1 CONNECTION AND DISCONNECTION OF PROBES cesses e 20 4 2 ADJUSTMENT OF KEYBOARD HEIGHT 20 4 3 STARTING OF THE DEVICE EE 20 5 PRESENTATION OF THE DEVICE wisicccsssiscssssssscassossecssosasctensssecaseasovesscssecbasscoassenssveseasecsbstanossestessevasendeus 22 5I KEYBOARD ILLUSTRATION M 22 5 1 1 Keyboard explanation cccccccssssssssccccecsessnsaccececsessnsecesececeesessnaesececsesessnaeaeeececsesseaesececsceesscsnaesecees 23 2 SCREEN EE 25 5 3 CONTEXTUAL MENUS cases eege Egeter gees dee 25 5A SETTINGS KEY NUMBER 34 iiie ri cr soars EES 27 6 B MODE IMAGING KEY NUMBER 4 ee eeeeee ee eene teen eene ento ene tn ennenen ennenen ennenen ennenen 31 6 1 DEPTH KEY NUMBER 16 31 6 2 FREQUENCY KEY NUMBER 17 isses inner nensi EN E EE EEI RIKER asia rase nennen 31 6 3 GAIN KEY NUMBER AL 31 6 4 TGC TIME GAIN CONTROL KEYS NUMBER 24 31 G15 FOCUS KEY NUMBER 7 rii t
29. Aaprt 1cm Maximum Index Value 0 87 0 34 a Pra MPa 2 19 P mW 12 a Min Palz lea mlzs Ze cm Zbp cm Associated acoustic Zp em parameters zau max cm 3 dealZb cm laut MHz 6 29 6 29 a Dim A X 0 92 a Y 0 58 a ty us 0 27 prr Hz 64 Other information pr at max 4 20 deq at max cm loa at max MI W cm 228 Probe model E610A Mode CFM TIS TIB Index label MI Non scan N TIC can on scan Aaprt lt 1cm Aaprt 1cm Maximum Index Value 0 87 0 38 a Pra MPa 2 20 P mW 12 8 a Min Pg z lta n z A cm Zpp cm Associated acoustic Se cm parameters zat max cm 3 deql p cm fawf MHz 6 29 6 16 6 29 a Dim A X 0 92 a Y 0 58 a ty HS 0 27 prr Hz 18 9 Other information prat max 4 20 deq at max cm La g 8t max MI W cm 230 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 100 sur 173 BECM Noveko Probe model E610A Mode PW TIS TIB Index label MI Non scan TIC can 2 2 on scan Aaprt lt icm Aaprt 1cm Maximum Index Value 0 46 0 64 1 20 a Pra MPa 1 15 P mW 22 22 a Min Palz lea mlzs Zs cm Zbp cm Associated acoustic 2b em 25 parameters zat max loi cm 3 deq 2p cm T wf MHz 6 16 6 16 6 16 a Dim apr x 0 92 0 92 a Y 0 58 0 58 a ty us 1 84 prr Hz 5120 Other information Dr at max lpi 2 18 deq at max lpi cm loa at max MI W cm 40
30. CFM Chitty British Journal of Obstetrics amp Gynaecology jan 1994 vol 101 P 132 135 Biometry 2000 Fetal growth charts by the Coll ge Francais d Echographie Foetale CFEF the French College of Fetal Ultrasonography and INSERM U 155 B CFM CFEF Gynecol Obstet Fertil 2000 Jun 28 6 435 45 Hadlock FP Deter RL Harrist RB Park SK Estimating fetal age Computer assisted analysis of multiple fetal growth parameters G B CFM Hadlock Radiology 1984 152 497 502 Hansmann M Hackel er B Staudach A n e Femur Length e mn Ultrasound Diagnosis in Obstetrics and Gynecology Springer Verlag 1990 Hansmann ISBN 0 387 15348 9 Springer Verlag New York P 431 Mineo Aoki Motohiro Yamada e Evaluation of fetal growth Obstetrics and gynecological treatment Vol 47 NO 5 1983 11 e Norio Shinozuka Haruo Masuda Hideroni Kagawa Yuji Taketani Standard Values of Ultrasonographic Fetal Biometry Jpn Med Ultrasonics Vol 23 No 12 1996 P 877 888 Mineo Aoki Motohiro Yamada Evaluation of fetal growth Obstetrics and gynecological treatment Vol 47 NO 5 1983 11 Rempen A Biometris in der fruehgravitaet I trimenon der Frauernarzt 32 1991 425 430 Hansmann M Hackel er B Staudach A Fetal trunk cross sectional area Gestational sac Head Circumference Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 111 sur 173 Ultrasound Diagnosis in Obstetrics and
31. CFM mode a User defined distance is available Click in the list of protocol measurements on User defined distance It is now possible to rename the distance Click Enter and the curser for making the user defined Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 67 sur 173 BECM Noveko distance with the specific name is available on the screen The measurement is made like described in chapter 18 1 If a patient file is open see chapter 19 the user defined distance will be stored in the report with the specific name The renamed user defined distance stays available at the end of the protocol measurement list until the device is shut down If you wish to store a user defined distance also after turning off you should use the function User defined protocol item see chapter 18 2 3 18 2 User protocols The user can decide individually which measures and tables should be used by entering a user protocol Activation of the user protocols in the Setting menu see chapter 5 4 Click Select left in the window User Protocols and Annotations A new screen window is displayed The list of available applications is displayed in the first column in the left window Click Select on the wanted application In the second column in the left window the list of names of the available protocols in the selected application is displayed When clicking Select on one of the protocols the content of the protocol with
32. Click on the key Rename in the contextual Preset menu A window appears in the preset column with the curser ready for entering the new name of the Preset with the alphanumeric keyboard After entering the new name of the preset validation of the name modification by clicking Enter on the alphanumeric keyboard or by clicking Select The new name of the preset is stored in the device The device does not automatically load the renamed preset See chapter 17 2 1 on how to load a preset Only user presets can be renamed Factory presets made by ECM cannot be renamed Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 65 sur 173 BECM Noveko 17 2 4 Delete a preset Activation of the list of applications and presets by clicking the key Preset Key number 33 The available applications are displayed on the upper left of the screen Pass the curser on the list of applications and Press Select right or left button on the wanted application in which the preset should be deleted Afterwards press Select with the right button on the preset that should be deleted Click on the key Delete in the contextual Preset menu The device is deleting the selected preset If the preset selected for delete is loaded and in use the device refuses to delete it and an error messages occurs Load another preset See chapter 17 2 1 and follow the procedure for deleting a preset once again Only user presets can be deleted Factory preset
33. Contextual menu 38 8 2 POSITIONING AND SIZE OF THE CFM po 38 8 3 FREQUENCY KEY NUMBER 17 geesde e o eO da a EUROS Ge deed ie aro Ee Ee pe EVEN 39 8 4 GAIN KEY NUMBER DL 39 8 5 PRF KEY NUMBER J e e deeegeieceer eege Eiegeeeg gege rente same terne ner EEEE IERES NERS ASEE EEEE eg 39 816 STEERING KEY NUMBER 11 2 03 dsecceesiccanes czeccesd cadedsaeakesdectceaneedvaievdocdadleantecdevsesusnueesaccdeddesdasivaetediasdesa TERETERE 39 8 7 REJECT KEY NUMBER 10 RM 39 8 8 ECHO FILTER CONTEXTUAL MENU 39 8 9 WALL FILTER CONTEXTUAL MENU s cs secesesicdee coven cesasesssavesseucesascesceessasoseieesosdesedeesvaseseedcesaieoveesedasivetedevncesureonye 39 8 10 EMISSION POWER CONTEXTUAL MENU 30 8 11 CFM AVERAGE CONTEXTUAL MENU s ee ee 39 8 12 CFM FIRINGS CONTEXTUAL MENU 40 8 13 B MODE CONTROLS esee terea rede dee ae EERSTEN EE ac deplace nets PER Red e e Eee Re Fe D a 40 9 PW MODE IMAGING KEY NUMBER 6 eere ernst e eere en etre eost ro tone to ste en neee enoe 41 9 1 POSITIONING AND SIZE OF THE PW GATE EN 41 9 2 FREQUENCY KEY NUMBER B 1 nier sneennnensneeenneesneensnensneesneesnnenss 41 9 3 GAIN KEV NUMBER 6 see men in nl eese et tete vede eee eese aie dette eere etes ehe idee erobert e geegent Dese 41 9 4 EMISSION POWER CONTEXTUAL MENU 41 9 5 PRF IKEY NUMBER KT te ere eiie eroe sae Er tee eee e e pe EUER E EE e pe EORR 41 9 6 STEERING KEY NUMBER a oT 41
34. Distance Stenosis Surface Left Ext Carotid Artery Left External Carotid Artery Distance Surface Stenosis Distance Stenosis Surface Right Ext Carotid Artery Right External Carotid Artery Distance Surface Stenosis Distance Stenosis Surface Left Int Carotid Artery Left Internal Carotid Artery Distance Surface Stenosis Distance Stenosis Surface Right Int Carotid Artery Right Internal Carotid Artery Distance Surface Stenosis Distance Stenosis Surface Left Vertebral Artery Left Vertebral Artery Distance Surface Stenosis Distance Stenosis Surface Right Vertebral Artery Right Vertebral Artery Distance Surface Stenosis Distance Stenosis Surface Left Subclavian Artery Left Subclavian Artery Distance Surface Stenosis Distance Stenosis Surface Right Subclavian Artery Right Subclavian Artery Distance Surface Stenosis Distance Stenosis Surface Innominate Artery Innominate Artery Distance Surface Stenosis Distance Stenosis Surface Left Humeral Artery Right Humeral Artery Left Brachial Artery Right Brachial Artery Version 3 du 16 07 2012 Left Humeral Artery Right Humeral Artery Left Brachial Artery Right Brachial Arte
35. If the measured field strength in the location in which the Imagyne equipment is used exceeds the applicable RF compliance level above the Imagyne equipment should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Imagyne equipment b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 90 sur 173 BECM Noveko TABLE 6 Recommended separation distances between portable and mobile RF communications equipment and the Imagyne equipment The Imagyne equipment is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the Imagyne equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Imagyne equipment as recommended below according to the maximum output power of the communication equipment Separation distance according to frequency of transmitter m Rated maximum output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Ww d 124VP d 1 24 P d 2 3VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 T 12 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output p
36. Max Reject 10 8 8 EchoFilter Contextual menu Activation and adjustment of the Echo Filter with the keys Echo Filter and Echo Filter in the contextual CFM menu The Echo Filter is filtering the strong amplitude echos The Echo Filter level is displayed on the right of the screen Min Filter 0 Max Filter 250 8 9 Wall Filter Contextual menu Activation and adjustment of the Wall Filter with the keys Wall Filter and Wall Filter in the contextual CFM menu The Wall Filter level is displayed on the right of the screen Min Wall Filter 0 Max Filter 7 8 10 Emission Power Contextual menu Increase and decrease of the CFM emission power by the keys Power and Power in the contextual CFM menu The updated emission power scale is displayed on the right of the screen 8 11 CFM Average Contextual menu Activation and adjustment of the time average between the CFM images by the keys CFM Average and CFM Average in the contextual CFM menu Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 39 sur 173 BECM Noveko The updated Average level is displayed on the right of the screen The CFM average scale goes from 0 to 200 with a last level named A 8 12 CFM Firings Contextual menu Adjustment of the number of CFM firings by the keys CFM Firings and CFM Firings in the contextual CFM menu When the number of firings is increased the sensibility of the CFM is also increased but the frame rate is decr
37. TIB Index label MI Non scan Non TIC can 2 2 Aaprt lt icm Aaprt 1cm scan Maximum Index Value 1 06 1 19 a Pra MPa 3 0 P mW 31 a Min Palz lea mlzs Ze cm Zbp cm Associated acoustic Zb cm parameters z at max loi cm 3 deq 2p cm Pat MHz 7 96 7 97 8 06 a Dim prt X 0 9 a Y 43 a ty HS 0 16 prr Hz T1 Other information Dr at max loi 68 deq at max lpi cm La at max MI W cm 371 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 98 sur 173 BECM Noveko Probe model L738P Mode PW TIS TIB Index label MI e Non scan Non TIC can 2 2 Aaprt lt icm Aaprt 1cm scan Maximum Index Value 0 73 2 29 3 51 a Pra MPa 1 82 P mW 78 78 a Min Palz lea mlzs Ze cm Zbp cm Associated acoustic Zb cm 1 parameters z at max lpi cm 3 degl2p cm Laut MHz 6 16 6 16 6 16 a Dim As prt X 0 9 0 9 a X 43 43 a ty us 1 84 prr Hz 5120 Other information Dr at max lei 3 44 deq at max lpi cm La at max MI W cm 110 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 99 sur 173 BECM Noveko Probe model E610A Mode B TIS TIB Index label MI Non scan TIC can 2 2 on scan Aaprt S1cm
38. The operator name is entered in the Setting menu see chapter 5 4 Entering of comments in the window Comments by the alphanumeric keyboard Validation by clicking Comments OK Entering of a conclusion in the window Conclusion by the alphanumeric keyboard Validation by clicking Conclusion OK All elements which have been added to the report during the examination with an open patient file are stored in the report and visible when clicking on each element The measures from the protocols are listed in the report If the same measurement was made twice or more the average result is calculated in the report 20 1 Display of Report The report can be visualized in two ways either as a list or as a text When the report is displayed as a list click in the right bottom corner on the window Text to change to the display as a text To return to the list visualization click on the same window now named List 20 1 1 List display of Report All information is displayed in the list in a compressed way The stored images are listed at the end of the report by their names Click on the name of the image to see the icon displayed in the top of the screen If you want to delete a measurement in the report place the curser on the wanted measurement and click Select The measure is highlighted in the list Click in the box Delete on the left of the screen to erase the measurement 20 1 1 1 List display of a report in Obstetrics When a measure is used i
39. Volume See chapter 12 3 2 Multicut See chapter 12 3 3 Slanting cut See chapter 12 3 5 Cube See chapter 12 3 4 Explorer 3D See chapter 12 3 6 Smoothening See chapter 12 2 15 Opacity See chapter 12 2 6 Luminosity See chapter 12 2 7 Zoom See chapter 12 2 8 Reject see chapter 12 2 10 Contrast See chapter 12 2 11 Color See chapter 12 2 12 16 7 2 B controls Gain See chapter 6 3 Dynamic See chapter 6 7 Gamma See chapter 6 17 16 8 Measures Measures can be made in post processing on previously stored images and sequences Load the selected image or sequence see chapter 14 3 and follow the above described procedures for making a measure see chapter 15 All measures on stored images and sequences can be corrected and remade in post processing Load the image or sequence with the measure see chapter 14 3 The procedure for correction of measures is the same as for new measures see chapter 15 After correction and or remake of the measure the image or sequence can be stored again with the new measure by clicking Store Image or Store sequence see chapter 14 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 64 sur 173 BECM Noveko 17 Applications and Presets Key number 33 17 1 Applications Activation of the list of applications and presets by clicking the key Preset Key number 33 The available applications are displayed on the upper left of the screen Click Select left or ri
40. W cm 188 Probe model P320R Mode CFM TIS TIB Index label MI Non scan Non TIC can 2 2 Aaprt lt icm Aaprt 1cm scan Maximum Index Value 1 70 1 42 Pra MPa 2 49 P mW 122 Min Palz lea mlzs Ze cm Zpp cm Associated acoustic n cm parameters z at max loi cm 6 degl2p cm Tat MHz 2 14 2 14 2 5 Dim Aaprt X 1 63 Y 1 64 ty us 0 474 prr Hz 16 Other information Dr at max lei 3 87 deq at max lpi cm La at max MI W cm 188 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 106 sur 173 BECM Noveko Probe model P320R Mode PW TIS TIB Index label MI s Non scan Non TIC can Aaprt lt 1cm Aaprt 1cm scan Maximum Index Value 0 55 0 63 2 22 Pra MPa 0 79 P mW 98 Mira nf 64 Z cm 3 Zpp cm 2 8 Associated acoustic m em S E parameters z at max loi cm 6 degl2p cm Lat MHz 2 07 2 07 2 07 Dim Anr X 1 63 1 63 Y 1 64 1 64 ty Hs 2 67 prr Hz 5120 Other information p at max li 122 deq at max lpi cm La at max MI W cm 21 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 107 sur 173 BECM Noveko Probe model 4DC540V Mode B TIS TIB Index label MI Non scan me TIC Aaprt lt 1cm Aaprt 1c
41. a This probe is not appropriate for trans cranial or cephalic application on a new born baby Probe model C360V Mode CFM TIS TIB Index label MI E Non scan Non TIC can Aaprt lt 1cm Aaprt 1cm scan Maximum Index Value 0 99 0 30 a Pra MPa 1 56 P mW 25 a Min Pg z lta mls Zg cm Zpp cm Associated acoustic m em parameters z at max loi cm 6 degl2p cm fawr MHz 2 49 2 49 3 05 a Dim Aaprt x 21 a y 13 a ty Hs 1 02 prr Hz 119 Other information Dr at max lei 2 63 deq at max lpi cm Ina at max MI W cm 76 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 92 sur 173 BECM Noveko Probe model C360V Mode PW TIS TIB Index label MI Gn Non scan Non TIC Aaprt lt 1cm Aaprt 1cm scan Maximum Index Value 0 71 0 65 2 14 a Pra MPa 1 13 P mW 88 a Min Palz lea 5 1 54 pA cm 2 8 Zbp cm 2 8 o r e z at max lpi cm 6 deql b cm Lat MHz 2 54 2 54 2 54 a Dim Aart X 21 21 a Y 13 13 a ty Hs 2 18 prr Hz 5120 Other information Dr at max lpi 1 91 deq at max lpi cm loa at max MI W cm 33 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 93 sur 173 BECM Noveko Probe m
42. alphanumeric keyboard or press Select If the renamed image or sequence is from the current application and thus displayed as a thumbnail above the contextual menu the new name will also appear on the thumbnail 14 3 5 Export To select an image or a sequence to export pass the cursor with the trackball on the list in the second column The names will now be highlighted successively in blue A thumbnail of the selected image is displayed below the list Press Select with the right button The selected image or sequence can now be exported to an external device To export insert a CD or a USB device Click on the key Export CD or Export USB in the contextual Review menu The selected image or sequence is copied to the external media but not deleted from the hard disk storage If no external media is available for exporting an error message will occur 14 3 6 Delete Contextual menu To select an image or a sequence to delete pass the cursor with the trackball on the list in the second column The names will now be highlighted in blue A thumbnail of the selected image is displayed below the list Press Select with the right button The selected image or sequence can now be deleted by pressing the key Delete in the contextual review menu Exit of the Review mode by clicking Review once again and return to the previously used imaging mode Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 54 sur 173 BECM N
43. domestic Harmonic emissions Class A and can be used in domestic establishments and those directly connected to the public CEI 61000 3 2 low voltage power supply network under the condition of the following warning Warning This equipment system is intended to be used by health professionals This Voltage fluctuations equipment system can cause radioelectric perturbations or it can affect the behaviour Flicker emissions Complies of a nearby electronic equipment It may be necessary to take attenuation measures like re orienting or relocating the Imagyne equipment or shielding the location immunity of the Imagyne equipment NOTE 1 The use of cables or accessories different from those specified by ECM may have as a consequence an increase of emission or a decrease of Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 88 sur 173 BECM Noveko TABLE 2 Guidance and manufacturer s declaration electromagnetic immunity assure that it used in such an environment The Imagyne equipment is intended for use in the electromagnetic environment specified below The customer or the user of the Imagyne equipment should Immunity test IEC 60601 test level Compliance level Electromagnetic environnement guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are cover
44. from an opened group to the list of protocol calculations click Select in the top of the protocol window at the name of the group The list of protocol calculations and groups is now displayed Follow the procedure described above to select a new protocol group and calculation See the list of the content of the vascular protocol in chapter 29 Exit of the Protocol menu by pressing the key Protocol Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 72 sur 173 BECM Noveko 19 Patient file Key number 31 Activation and deactivation of the patient menu and patient files by clicking the key Patient Key number 31 The Patient menu is composed of 4 different parts In the left upper window the list of existing patients is displayed The patients are listed by their names and or ID The first name if it has been entered is also displayed Only the left Select button is available for use in the patient menu To list the patients alphabetically click on the column Name When clicking again the list is alphabetically from the end of the alphabet Click on the column ID for listing according to ID Click Select on the patient to open the patient file Exit of the patient menu by clicking the key Patient again When selecting an existing patient file the previously made reports are listed beneath the list of patients When clicking on one of the reports the content of the report is displayed on the scree
45. gain by turning the B knob The updated gain level is displayed on the right of the screen 12 2 2 Acquisition Speed contextual menu See chapter 12 1 5 12 2 3 Resolution contextual menu Adjustment of the 4D resolution by the keys Resolution and Resolution contextual 4D menu The resolution influences the frame rate The selected Resolution is displayed at the screen Low Medium or High Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 47 sur 173 BECM Noveko 12 2 4 Sweeping contextual menu See chapter 12 1 1 12 2 5 4D Field of View contextual menu See chapter 12 1 2 12 2 6 Opacity Key number 5 Adjustment of the opacity by turning the CFM knob key number 5 The updated opacity level is displayed on the right of the screen Min opacity 0 Max opacity 30 12 2 7 Luminosity Key number 6 Adjustment of the luminosity by turning the PW knob key number 6 The updated luminosity level is displayed on the right of the screen Min luminosity 0 Max luminosity 23 12 2 8 Zoom Key number 8 Zooming on the volume image by turning the Zoom knob key number 8 In 4D mode the full screen zoom is always available no matter which zoom mode is selected see chapter 6 6 12 2 9 Rotate Key number 8 Activation of the rotating function by pressing the Zoom knob key number 8 A white circle around the volume image indicates that the rotating is active Turn the Zoom knob to rot
46. its different measurements and tables is shown in the right part of the window The list of available authors for each table is displayed under the list of sub calculations Some protocols do not contain any authors 18 2 1 Create a new user protocol Activation of the user protocols in the Setting menu see chapter 5 4 by clicking Select left in the window User Protocols A new screen window is displayed with the list of available applications in the first column in the left window Click Select on the wanted application in which you want to create a new protocol In the screen window User protocols click Select in the window Create a protocol in selected application The new protocol appears in the second column in the list and is ready to be defined in the right of the window To rename the new protocol enter the text with the alphanumeric keyboard in the title box called Protocol Edition above the list of calculations Select the content of the new user protocol by ticking the box corresponding to each measure and calculation The authors available for each table are displayed in the lower part of the screen Select the wanted author s by ticking the corresponding box for each table If no author is selected by the user the system automatically selects the first author in the list When the selection of the content of the user protocol is determined press Save selected protocol at the bottom of the screen The new user protocol is no
47. length Reevaluation of relation to menstrual age 5 18 weeks with high resolution real time US Crown rump Length CRL Hadlock Radiology 1992 182 501 505 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 110 sur 173 mn n e e e Anteroposterior Abdominal Diameter Em e Anteroposterior trunk Diameter by Transverse Trunk Diameter APTD TTD e Biparietal Diameter em e e B zm e m m m mn BECM Noveko Hansmann M Hackel er B Staudach A Ultrasound Diagnosis in Obstetrics and Gynecology Springer Verlag 1990 B CFM Hansmann ISBN 0 387 15348 9 Springer Verlag New York P 438 Mineo Aoki Motohiro Yamada Evaluation of fetal growth B CFM Osaka Obstetrics and gynecological treatment Vol 47 NO 5 1983 11 Rempen A Biometris in der fruehgravitaet I trimenon E ES der Frauernarzt 32 1991 425 430 H P Robinson Honory Senior Registrar A critical evaluation of sonar crown rump length measurements British Journal of Obstetrics and Gyneacology September B CFM Robinson 1975 82 702 710 Takashi Okai Department of Obstetrics and Gynecology Faculty of Medicine University of Tokyo Studies on Fetal Growth and Functional Developments Official Journal of the Japan Society of Obstetrics and Gynecology B CFM Tokyo ACTA OBST GYNEC JPN Vol 38 No 8 pp 1209 1217 1986 Chitty LS Altman DG Charts of Fetal Size 4 Femur Length B
48. lt icm Aaprt 1cm Maximum Index Value 0 46 0 64 1 20 a Pra MPa 1 15 P mW 22 22 a Min Palz lea mlzs Zs cm Zbp cm Associated acoustic 2b em 25 parameters zat max loi cm 3 deq 2p cm T wf MHz 6 16 6 16 6 16 a Dim apr x 0 92 0 92 a Y 0 58 0 58 a ty us 1 84 prr Hz 5120 Other information Dr at max lpi 2 18 deq at max lpi cm loa at max MI W cm 40 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 103 sur 173 BECM Noveko Probe model C614P Mode B mode 2D TIS TIB Index label MI Non scan Non TIC can Aaprt lt 1cm Aaprt 1cm scan Maximum Index Value 0 52 0 20 a Pra MPa 1 28 P mW 7 a Min Pg z lta mls Z cm Zpp cm Associated acoustic m em parameters z at max loi cm 3 degl2p cm fawf MHz 6 12 6 13 a Dim Aaprt X 1 06 a Y 0 55 a ty Hs 0 200 prr Hz 64 Other information p at max lpi 2 42 deq at max lpi cm La at max MI W cm 56 Probe model C614P Mode CFM TIS TIB Index label MI E Non scan Non TIC can Aaprt lt 1cm Aaprt 1cm scan Maximum Index Value 0 52 0 45 a Pra MPa 1 28 P mW 16 a Min Palz lea 5 1 Ze cm Zbp cm Associated acoustic m cm parameters zat max lei cm 3 deq 2p cm Lat MHz 6 13 6 10 6 13 a Dim apr x 1 06 a Y 0 55 a ty Hs 0 200 prr Hz 1
49. on the PW mode Deactivation of the angle correction by pressing the key Angle in the contextual PW menu 9 8 Baseline Key number 14 Raising and lowering of the base line of the PW PRF scale by the Baseline rocker switch Upwards activation raises the line downwards activation lowers the line The PRF scale is updated to the right of the PW frame 9 9 Invert Contextual menu Inversion of the PRF scale in PW by the key Invert in the contextual PW menu The peaks underneath the baseline will be above and conversely When the Invert function is activated the key is highlighted in red and Invert is displayed on the top of the PW spectrum 9 10 Audio Key number 15 Adjustment of the acoustic volume of the PW by the Audio rocker switch 9 11 Ima Pulse Automatic optimization of PW spectrum Contextual menu Automatic optimization of the PW spectrum by the key Ima Pulse in the contextual PW menu The Imagyne device automatically optimizes the whole PW spectrum When the automatic optimization is activated the key Ima Pulse is highlighted on red To deactivate the function press the key Ima Pulse again 9 12 High PRF Contextual menu Activation and deactivation of the High PRF function by the key High PRF in the contextual PW menu The high PRF enables to measure high velocities The Simplex mode is activated by default with only the PW in live The PRF scale is updated When the High PRF function is activated the key is highlig
50. on the probe itself Click Select Right to return to the repositioning Click Select Left to validate Image format Choice of image format when saving jpeg jpeg bitmap bmp and or Dicom dic by ticking the boxes The format imagenv raw data is always saved simultaneously Clip format Choice of clip format when saving a sequence avi and or Dicom by ticking the boxes The format clipenv raw data is always saved simultaneously Zoom Choice of zoom mode Full screen or Picture in Picture See the paragraph 6 6 for a complete description of the two zoom modes Autofreeze Choice of the time of non use before passing automatically into freeze mode 5 10 or 15 minutes Stenosis tools Choice of ellipse or Trace used for measuring stenosis Annotations When ticking the box the arrow is placed before the text box when adding an annotation Otherwise the textbox is placed before the arrow See chapter 15 1 6 about annotations Distances Choice of automatic appearance of 4 successive distances in measure mode Otherwise one automatic distance appears and further measure selections are made in the contextual menu See chapter 15 about measures B Measures values on US image If the box is ticked the values of the B measures are displayed on the image near to the measurement itself If the box is not ticked the values are displayed in the lower left part of the screen See chapter 15 PW automatic control Choice of automatic ad
51. scale by the keys Time Scale and Time Scale in the contextual CW menu The scale in seconds is updated The time scale goes from 1 to 10 seconds 11 9 Invert Contextual menu Inversion of the PRF scale in CW by the key Invert in the contextual CW menu The peaks underneath the baseline will be above and conversely When the Invert function is activated the key is highlighted in red 11 10 Color Contextual menu Coloration of the CW spectrum by the keys Color and Color in the contextual CW menu The coloration is active on the factory presets Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 46 sur 173 BECM Noveko 12 4D Imaging Key number 28 Connect the volumetric 4D probe on the probe connector 1 the first connector to the right The 4D probe is active for 2D imaging functioning like a standard convex probe 12 1 Pre 4D Press the key 4D key number 28 to activate the 4D imaging mode The 4D box appears on the screen in the middle of the B image Display of the pre 4D contextual menu To adjust the position of the box click inside the box and drag it with the trackball Click Select once again to validate the new position The height of the 4D box Clipping can be adjusted by clicking on the upper or the lower line The line gets blue and can be dragged with the trackball Click Select right to switch between the upper and the lower line Click Select left to validate the new si
52. scanner must be used according to the ALARA principle meaning that the operator must maintain the transmit power level and the length of the exposure at the lowest possible level As Low As Reasonably Achievable Consequently the operator must use the ultrasound in a safe way in order to ensure the maximum protection of the patient This means that the operator must assume that there might be unidentified risks during the use of ultrasounds and therefore reduce the exposure time of the patient as well as the transmit power This can be done by following the ALARA principle As Low As Reasonably Achievable which associates some simple rules for obtaining a diagnosis while using the least amount of acoustic energy How to perform a safe examination When starting an examination always adjust the transmit power at the lowest possible level Increase the power during examination if necessary in order to obtain a satisfactory image or Doppler signal while keeping the review of MI and or TI indexes Do not hold the probe in a fixed position longer than necessary As soon as the image has been frozen take the probe away from the patient s skin Do not continue the examination longer than necessary It is important to reduce the time of patient exposure to ultrasounds as much as possible 2 1 3 Interpretation of MI and TI parameters It is the operator s responsibility to foresee the risks linked to the output energy of the device and to ac
53. the thermal printer are correct like described above Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 80 sur 173 BECM Noveko 22 Cleaning and disinfection instructions The protection of patients and staff from risks of infections is essential for all health care institutions A treatment level corresponds to each risk level in order to obtain the needed level of microbiological quality 22 1 Cleaning and disinfection of the device The device has a low infection risk This risk level corresponds to the use of so called non critical medical devices which means devices which are not in direct contact with the patient The needed treatment for this type of medical device is a low level disinfection especially bactericidal The following disinfection solutions have been tested and their compatibility with the components of the device has been proved Cidex Cidex plus Cidex OPA It is strongly recommended to use one of these solutions in order to avoid any deterioration during the cleaning and disinfection procedure N WARNING The use of any other disinfecting solution than the ones indicated above is dangerous as it may damage the components of the device Check the list of specified agents carefully In order to ensure proper cleaning and disinfection please follow the following procedure 1 After every patient examination or as often as necessary wipe the keyboard and the external sur
54. to the GA Ref The system also enables to estimate the GA based on the measurement result by pressing GA Estimation in the contextual OB protocol menu If this is judged more correct by the user than the initial GA the user can validate the new LMP by pressing LMP Validation in the contextual OB protocol menu The new validated LMP date now becomes the GA reference NB The date format is selected in the Settings menu see Chapter 5 4 19 4 2 2 Without entering the LMP However it is also possible to start an examination without entering the LMP information In this case no GA Ref is displayed The contextual obstetrical protocol menu then enables to estimate the Gestational age according to the measures by pressing GA Estimation in the contextual OB protocol menu If the user judges this date to be correct the LMP can be validated by pressing LMP Validation in the contextual OB protocol menu The validated LMP date now becomes the GA reference 19 4 2 3 Obstetric Report mode GA Access to this mode in the Setting menu chapter 5 4 when ticking the box Obstetric Report mode GA In this mode all available protocol measures are used for calculating the GA You can still press GA estimation in the contextual OB protocol menu to see the new calculated LMP and EDD if necessary 19 4 2 4 Multiple pregnancies Number of fetuses When a patient file is open in the application Obstetrics a choice can be made between Single Twin or Triplet births C
55. utilisateur Imagyne 2 02 EN v3 Page 69 sur 173 BECM Noveko See the list of the content of the general protocol in chapter 29 18 4 Protocols in Abdominal application Same procedure as for the above listed protocols For measurements composed of three parts used for a volume calculation for instance Prostate Start by making the first two distance measurements Width Height as described above Defreeze Freeze again when the wanted cut is found Load the last measurement Depth by clicking left Select and make the third distance measurement The volume calculation is made automatically by the device See the list of the content of the abdominal protocol in chapter 29 18 5 Protocols in Anesthesia Same procedure as for the above listed protocols See the list of the content of the anesthesia protocol in chapter 29 18 6 Protocols in Cardiology application In the Preset menu select the application Cardiology Select the imaging mode B M CFM PW CW Press Protocols The available protocol calculations are displayed in a list in the window on the left of the screen All protocol calculations marked with indicate a group See chapter 18 1 1 about how to use the grouped protocols To return from an opened group to the list of protocol calculations click Select in the top of the protocol window at the name of the group The list of protocol calculations and groups is now displayed Follow the procedure described above to select a n
56. 2 4 Other information p at max lpi 2 42 deq at max lpi cm loa at max MI W cm 56 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 104 sur 173 BECM Noveko Probe model C614P Mode PW TIS TIB Index label MI Non scan Non TIC can Aaprt lt 1cm Aaprt 1cm scan Maximum Index Value 0 32 0 79 0 93 a Pra MPa 0 79 P mW 27 27 a Min Palz lea 5 1 Ze cm Zbp cm Associated acoustic 2b cm 3 parameters z at max loi cm 3 deql p cm fawf MHz 6 16 6 16 6 16 a Dim As prt X 1 06 1 06 a Y 0 55 0 55 a ty us 1 85 prr Hz 5120 Other information Dr at max loi 1 49 deq at max lpi cm La at max MI W cm 17 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 105 sur 173 BECM Noveko Probe model P320R Mode B mode 2D TIS TIB Index label MI Non scan Non TIC can z 2 Aaprt S1cm Aaprt 1cm scan Maximum Index Value 1 70 0 42 Pra MPa 2 49 P mW 41 Min Palz lea 5 1 Z cm Zbp cm Associated acoustic 2b cm parameters z at max loi al cm 6 deql b cm Lat MHz 2 14 2 14 Dim Aaprt X 1 63 Y 1 64 ty us 0 474 prr Hz 32 Other information p at max lpi 3 87 deq at max lpi cm loa at max MI
57. B CFM Organ Measurement Result Bladder Width W xH x D x Pi 6 Height Volume Depth Prostate Width WxHxD x 0 52 Height Volume Depth Testes Width W xH x D x Pi 6 Height Volume Depth Left kidney Width Height Right kidney Width Height APPLICATION URO LOGY Mode PW Organ Measure tool Left Renal Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Acceleration Right Renal Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Acceleration Doppler Auto RI PI Speed Systole Speed Diastole S D Doppler Manual Trace RI PI Speed Systole Speed Diastole S D Doppler Manual RI Speed Systole Speed Diastole S D Acceleration Acceleration Time Acceleration APPLICATION URO Mode M LOGY Organ Measurement Left Renal Artery Heart Rate Right Renal Artery Heart Rate Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 163 sur 173 BECM Noveko APPLICATION VASCULAR B CFM Abbreviation Organ Measure tool Intima Media Thickness Left Com Carotid Artery Left Common Carotid Artery Distance Surface Stenosis Distance Stenosis Surface Right Com Carotid Artery Right Common Carotid Artery Distance Surface Stenosis
58. BECM Noveko IMACSYNE USER MANUAL Version 2 02 LE CE certificate for the ultrasound scanner Imagyne obtained in 2008 Imagyne reference 90 1933 Indice A User Manual reference 70 2180 Warning This manual must be read before using the equipment Manufacturer s address Distributor s address ECM ein 126 bd de la R publique F 16000 Angoul me ee T l 33 5 45 92 0357 b eexsuees Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 1 sur 173 BECM Noveko SUMMARY 1 INTRODUC TION umcC 9 2 SAFETY INSTRUCTIONS c 10 2 1 SAFETY INSTRUCTIONS FOR ULTRASOUND EQUIPMENT sese eee eee e 10 T User profiles 10 2 1 2 Acoustic 0101 10 2 1 3 Interpretation of MI and TI parameters iii 10 2 1 4 Accuracy of MI and TI parameters display ss 11 REA Em 11 2 3 ENVIRONMENTAL CONDITIONS OF USE ss ee ee ee ee 12 2 4 ELTECTRICAESAFETY eni ecelesie iet ve emule eun bert 12 2 5 PATIENT ENVIRONMENT eee eee 14 2 6 ELECTROMAGNETIC COMPATIBILITY eee eee e sssssesssseessesessreeseeenseee see ennnee see ensnee encens snneeneeeseneeneeesneens 14 2 7 PROBE AND EQUIPMENT COMPATIBILITY eee eee 15 SE EBEN EG 15 2 8 1 Probe types and corresponding applications 15 2 8 2 EE B 16 2
59. Click on the crosses to see all elements Select the wanted report The report is displayed on the screen Images and graphs can be selected for printing Click Print for printing the report with selected images and graphs The control Refresh updates the external media Exit of Import Export Archive Consult reports and return to Setting by pressing the key Clear Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 29 sur 173 BECM Noveko User Short Keys Possibility to enter up 10 user short keys Select the wanted short key for instance Key 1 in the left part of the box Then select in the right part the function you want to allocate to the short key The available functions for short keys are listed for each of the following modes B CFM and PW Click on Clear Short Key to delete the selection Exit of User Short Keys by pressing Clear or Setting To use the user short key when in imaging mode click Ctrl and the allocated number for instance 1 The function is carried on Exit of the Setting menu by pressing the key Setting or by pressing the key Clear Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 30 sur 173 BECM Noveko 6 B Mode imaging Key number 4 When turning the system on the B mode is displayed as the system s defaulting imaging mode The B mode is the basis also for other available modes M CFM PW CW When using one of the combined modes yo
60. E 64 16 7 AD IMODE cpc M 64 16 7 1 AD controls 64 16 7 2 BiCOMENOIS vs 64 HEAD cp 64 17 APPLICATIONS AND PRESETS KEY NUMBER 33 65 TZ L APPLICATIONS 25 nn tete 65 17 2 PRESETS c Et 65 17 21 LOO 4 preset ege EE 65 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 6 sur 173 BECM Noveko 17 2 2 Create a new Dreset eee 65 17 2 3 Rename a preset 17 2 Del te d preset 2 nn Ee Ee vere eui e egeo deele 18 PROTOCOLS KEY NUMBER 108 eese sees eenn eneon eenn enen 67 18 1 HOW TO MAKE A PROTOCOL MEASUREMENT 18 1 1 Protocol measurements with groups 18 1 2 Protocols in Duo 18 1 3 User defined distance Hie iecitt pte iive ie eio Ce Ee easet dE T y tesi ue ded Eee ERU uie pe deed sbavbestes 18 2 USER PROTOCOLS E MCI 18 2 1 Create a new user protocol sse 18 2 2 Delete a user protocol s cnie snene a a a A E S E 18 2 3 User defined RE E 18 2 4 Exit Of user tee 18 2 5 Activation of user Drotocols iii cesser 18 3 PROTOCOLSIN GENERAL APPLICATION 55 etes ENEE caseebeecesustescesenceucosebeey coda ese Ala edo a ch desee e peo Eae 18 3 1 Measurement of Intima Media Thickness IMT 18 3 2 Measurement of 3D Volume sese eee e eee 18 4 PROTOCOLS IN ABDOMINAL APPLICATION 18 5 PROTOCOLS IN ETS 18 6
61. F THE CW UNE d Ibn cans Pe ERE TR RT RUNE NEP ERE SERERE RE einen iii ge PER EE TERREA cannes SE TREE EE SES EP RE TERRE 45 11 2 GAIN KEY NUMBER EL 45 deua a ad qIUiiwi O 45 11 4 BASELINE KEY NUMBER 14 i eere Pr ete ee Ee CREE ERE REESE sasceosenes cage ed een ee NEE 45 hR Eos AUDIO KEY Js 45 11 6 NOISE REJECT CONTEXTUAL MENU 45 11 7 WALL FILTER CONTEXTUAL MENU 46 11 8 TIME SCALE CONTEXTUAL MENU 5 36 3 che eco tarder ee EHE PE e Eee e Eb lere te Ee bee bee Fert ree EORR 46 11 9 INVERT CONTEXTUAL MENU 46 11 10 COLOR CONTEXTUAL MENU 46 12 4D IMAGING KEY NUMBER 28 ssccscssssscsscsescsccssssccssssncsccecssccsscsessasencsscensesccasssessacsncsacensessenses 47 HI 47 12 1 1 Sweeping contextual menu 47 12 1 2 4D Field of View contextual menu 47 12 1 3 Dynamic contextual menu 47 K RETTEN 47 12 1 5 Acquisition Speed contextual menu 47 12 243 Dis oct Ede E Ede EE I 47 12 2 1 Gain Key n mber EE 47 12 2 2 Acquisition Speed contextual menu 47 12 2 3 Resolution contextual menu 47 12 2 4 Sweeping contextual menu 46 12 2 5 4D Field of View contextual menu 46 12 2 6 Opacity Key number SI 46 12 2 7 Luminosity Key number el 46 12 2 8 Zoom Key n mber B i c ti Eege eege 46 12 2 9 Rotate Key number 8 46 12 2 10 Reject Contextual
62. FORMULAS 2 5 nt edes eusd eco oer edes eue eon Pede ou eue d Lee e emen S eue neon eo eges S eue REDE UR TUER een d c PE RENE EUR 147 28 MAINTENANCE OF THE DEVIGCE 4 aeree eese eene enne tn nennen nenen tassa sena ena ens ens ense nenen 148 29 FACTORY PROTOCOLS FOR EACH APPLICATION scccsscssssssssssssssssseseesscesscssecscsssesessenees 149 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 8 sur 173 BECM Noveko 1 Introduction This manual includes all necessary information for installing and using the Imagyne ultrasound equipment Imagyne is an ultrasound device for diagnostic imaging Entirely digital PC based and using FPGA technology Imagyne provides imaging in B M and CFM modes as well as Doppler spectrums and CW Real Triplex is also provided B CFM PW Imagyne provides post processing meaning adjustment of imaging controls on frozen and stored images for a secure and facilitated diagnostic Imagyne is developed for the following applications General Abdominal Cardiology Gynecology Obstetrics Pediatrics Small parts Urology Vascular Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 9 sur 173 BECM Noveko 2 Safety instructions 2 1 Safety instructions for ultrasound equipment 2 1 1 User profile Warning This equipment must be used only by a user trained to the ultrasound imaging technique This training allows
63. Gynecology Springer Verlag 1990 Hansmann ISBN 0 387 15348 9 Springer Verlag New York P 36 Takashi Okai Department of Obstetrics and Gynecology Faculty of Medicine University of Tokyo Studies on Fetal Growth and Functional Developments Official Journal of the Japan Society of Obstetrics and Gynecology ACTA OBST GYNEC JPN Vol 38 No 8 pp 1209 1217 1986 Chitty L S Altman D G Charts of Fetal Size 2 Head Measurements British Journal of Obstetrics amp Gynaecology jan 1994 vol 101 P 35 43 Chitty L S Altman D G Charts of Fetal Size 2 Head Measurements Chitty drvd British Journal of Obstetrics amp Gynaecology jan 1994 vol 101 P 35 43 Chitty L S Altman D G Charts of Fetal Size 2 Head Measurements Chitty Pltd British Journal of Obstetrics amp Gynaecology jan 1994 vol 101 P 35 43 e mn mn e Biometry 2000 Fetal growth charts by the Coll ge Fran ais d Echographie Foetale CFEF the French College of Fetal Ultrasonography and INSERM U 155 Gynecol Obstet Fertil 2000 Jun 28 6 435 45 e m m BECM Noveko Hadlock FP Deter RL Harrist RB Park SK Estimating fetal age Computer assisted analysis of multiple fetal growth parameters HC FG B CFM Hadlock Radiology 1984 152 497 502 Hansmann M Hackel er B Staudach A Ultrasound Diagnosis in Obstetrics and Gynecology Springer Verlag 1990 B CFM Hansmann ISBN 0 387 15348 9 Sprin
64. Imagyne 2 02 EN v3 Page 147 sur 173 BECM Noveko 28 Maintenance of the device Repairing of the device None of the parts of the device can be repaired by any person who has not been authorized by the manufacturer Only a technician who has been trained and qualified by ECM can intervene for reparation of the device In case of breakdown or fault in the functioning of the device contact your distributor You will find the address of your distributor on the first page of this manual Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 148 sur 173 BECM Noveko 29 Factory protocols for each application APPLICATION GENERAL Mode B CFM Measure tool Measurement Result Anatomic M Distance Distance Distance Ellipse Ellipse Circumference Surface Trace Circumference Surface Stenosis Distance ID Ratio of 2 distances ED Stenosis Surface IS Ratio of 2 surfaces ES Ellipsoidal volume Volume Volume 4 3 pi xaxa x b a is the smallest axis 3D Volume Volume Volume 4 3 pi x W 2 x H 2 x D 2 Distance Ratio Distance A A B Distance B Surface Ratio Surface A A B Surface B Angle Angle Angle Intima Media Thickness Thickness APPLICATION GENERAL Mode PW Measure tool Measurement Doppler Auto RI PI Speed Systole Speed Diastole S D
65. Manual Trace RI PI Heart Rate Rate Acceleration Acceleration Time Acceleration APPLICATION OBSTETRICAL Mode M Abbreviation Organ Measure tool FHR Fetal Heart Rate GA Average Fetal Aorta Heart Rate Left Uterine Heart Rate Right Uterine Heart Rate MCA Middle Cerebral Artery Heart Rate UA Umbilical Artery Heart Rate Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 160 sur 173 BECM Noveko APPLICATION PEDIATRICS Mode B CFM Organ Measurement Result Left Hip Joint Angles Alpha Beta Right Hip Joint Angles Alpha Beta Spleen Dist A Dist B Left Kidney Width Height Right Kidney Width Height Pancreas Head Body Tail Duct Gall bladder Width Height Wall T Liver Width Height Bladder Width W xH x D x Pi 6 Height Volume Depth APPLICATION PEDICATRICS Mode PW Organ Measure tool Left Renal Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Acceleration Right Renal Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Acceleration Doppler Auto RI PI Speed Systole Speed Diastole S D Doppler Manual Trace RI PI Speed Systole Speed Diastole S D Dopple
66. Manuel utilisateur Imagyne 2 02 EN v3 Page 144 sur 173 BECM Noveko Left Uterin PI Schaffer Right Uterin RI Schaffer FG Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 145 sur 173 BECM Noveko Right Uterin RI Schaffer FG Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 146 sur 173 BECM Noveko 27 3 Formulas D Estimated Fetal Weight EFW author Hadlock Hadlock AC FL Log10 EFW 1 304 0 05281 AC 0 1938 Fl 0 004 FL Hadlock BPD AC FL Log10 EFW 1 335 0 0034 AC FL 0 0316 BPD 0 0457 AC 0 1623 FL Hadlock HC AC FL Log10 EFW 1 326 0 00326 AC FL 0 0107 HC 0 0438 AC 0 158 FL Hadlock BPD HC AC FL Log10 EFW 1 3596 0 00386 AC FL 0 0064 HC 0 00061 BPD AC 0 0424 AC 0 174 FL EFW in grammes g HC FL AC et BPD in centim tres cm Hadlock FP Harris RB Matinex Poyer J In utero analysis of fetal growth A sonographic weight standard Radiology 181 129 133 1991 e HC according to BPD and OFD HC BPD OFD 2 3 1416 D Conception Due Date and GA by LMP Conception LMP cycle 28 luteal 14 Due Date Conception 266 days GA by LMP 14 266 Due Date today formulas in days D Cephalic Index CI Cl BPD OFD 100 D FL HC ratio FL HC D FL AC ratio FL AC HC AC ratio HC AC FL BPD ratio FL BPD Version 3 du 16 07 2012 R f CD MA Manuel utilisateur
67. NE wccisscscceassssecccessoveassssveceasoutssensvedscsossnndesssnbbacgeuaesescnueed VETE AS EYE aee eere ERR Un 57 15 2 4 Annotation Contextual menu 57 15 2 5 Select Contextual menu eda ee rte tee sombres dea eet eese ER A dep aeta v EREA esa ssepe Epod eg 58 VEDAdIJgm 58 15 2 7 Delete Context al menu eret itsse tie eti v ee uta ub vede i ee eH uhr vessel thease terete at 58 15 2 8 Delete all Contextual menu 58 15 3 MEASURES IN PW AND B CFM PW e 58 15 3 1 Automatic measure Contextual menu 58 15 3 2 Semi automatic measure Contextual men 58 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 5 sur 173 BECM Noveko 15 3 3 Manual Trace measure Contextual menu 58 15 3 4 Rate Contextual menu 59 15 3 5 Flow Contextual menu 59 15 3 6 Arrow Contextual menu 59 15 3 7 Annotation Contextual menu 59 15 3 8 Select Contextual men 59 153 9 Hbc ect ORO UERSUM PEE IE EE 59 15 3 10 Delete Contextual menu 59 15 4 MEASURES INTERESSE EERSTEN Ve ERRARE EN 60 15 4 1 Time Contextual menu ertet tecto tee ERE eR Eno SU EU EENS Lee gea eoe e se o Pa ERRAT 60 15 4 2 Speed Contextual menu 60 15 4 3 Acceleration Contextual menu 60 15 4 4 Arrow Contextual menu 60 15 4 5 Annotation Contextual menu 60 15 4 6 Select Contextual men 60 b MAL gq U 60 15 4 8 Delete Context al men 2 e e este
68. PROTOCOLS IN CARDIOLOGY APPLICATION eene eene e nenne tennis sess ener tene ne sr sr inerte nnn nier eterne nennen 18 6 1 Body Surface Area ccccccccccccscssssscecececseseussecececeesssassecececeeseausaesececeeseaaaseesceesenssaeseeececeesecsseeeeeeeeesgs 18 6 2 Protocols in cardiology application in B mode sss sees eee eee 18 6 3 Protocols in cardiology application in Anatomic M mode 70 18 7 PROIOCOLSTNIGYNECOLOQGY EE 70 18 8 PROTOCOLS IN OBSTETRICS cesseccecsecececssececeesaecececeecesaececsesaececsuceececsaeeeceesaeesceeeecessaeeecseaaecesseeeecesseseenesaeess 71 18 9 PROTOCOLS IN PEDIATRICS iesen ER te cot eter e iere de ane ten eh ede robe Abas Sees Weed heel c dee en Eee 71 18 10 PROTOCOLS IN SMALL PARTS APPUCATION eene nennen eren nennen eren en tenenr sies enne tenens sese eterne nenne rennen nenne 71 18 11 PROTOCOLS IN UROLOGY 18 12 PROTOCOLS IN VASCULAR 19 PATIENT FILE KEY NUMBER 31 ssscssssssssscssssssssesssessessssssscnsesvessssssessessesessssssessesesesessessseasers 73 19 1 CREATE A NEW PATIENT ene enne nennen nennen sese se ERFIR EEEIEE se sese sese ERTER sese ese se sese sese sese se sese sese sens 19 2 MODIFY A PATIENT 19 3 SEARCH A PATIENT 19 4 START AN EXAMINATION 19 4 1 Examination without report 74 19 4 2 Examination in Obstetrics sess He estie tec ste ete eve eco cues beaded bea Fee a ae sus ve Ee d o eoo Ue ve lee e eo RUE FG 74 19 4 2 Ent ring the cis
69. Page 121 sur 173 BECM Noveko BPD Hadlock FG e ume Ed cime Pe EE EE H EN NINE RENI O ERN NENNEN NENNEN NENNEN e E UELLE S Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 122 sur 173 BECM Noveko BPD Osaka Identical ae O eer E2899 H O H O H S Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 123 sur 173 BECM Noveko BPD Hansmann FG es 5 mm 50 L mm 95 mm 240 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 124 sur 173 BECM Noveko Clavicle Yarkoni FG ow 39 mm Et Sim E CRL Hadlock FG Me mm CT ECT PM DE A A z MEN Cu pm COM NN Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 125 sur 173 BECM Noveko CRL Hansmann FG EC Lm E399 1 392 LE LE 9 E389 1 58 H B CRL Osaka Identical Me 7m o SSC il 7 CRL Rempen FG Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 126 sur 173 BECM Noveko CRL Tokyo FG e Et mem Srel FL CFEF FG S imm E3549 51 LB 2 E3864 54 LE S E2186 351 E E E59 84 8 LE 89 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 127 sur 173 BECM Noveko FL Ch
70. RU EES ects ERREUR EXER ERE ERE VER EE Ee 31 6 5 1 Focus Gap contextual menu 32 6 6 ZOOM KEY NUMBER 8 RM 32 6 6 1 Full screen mode 32 6 6 2 Picture in Picture mode iiic erret tee bein resi esse Sued redu ee tite en tasse Ev Nod tue 32 6 7 DYNAMIC CONTEXTUAL MENU 32 6 8 NOISE REJECT CONTEXTUAL MENU 32 6 9 IMA CROSS Leet a TUE 33 6 10 IMA VIEW AUTOMATIC IMAGE OPTIMISATION CONTEXTUAL MENU 33 6 11 BIOPSY CONTEXTUAL MENU 33 6 12 DUAL CONTEXTUAL MENU 33 6 13 EMISSION POWER CONTEXTUAL MENU 33 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 2 sur 173 BECM Noveko 6 14 IMA CLEAN CONTEXTUAL MENU 34 6 14 1 Edge Ima Clean contextual submen sise 34 6 14 2 Speckle Reduction Ima Clean contextual submenu ss 34 6 14 3 Grain Ima Clean contextual submenu iii 34 6 14 4 Line Ima Clean contextual submenu iii 34 6 14 5 Reset Ima Clean contextual submenu issus 34 6 15 ANATOMIC M CONTEXTUAL MENU 34 6 16 IMA LEVEL CONTEXTUAL MENU 34 6 17 GAMMA CONTEXTUAL MENU 34 6 18 EXTRA B TOOLS CONTEXTUAL MENU 34 6 18 1 B Average Extra B tools contextual sub menul ss 34 6 18 2 Color Extra B tools contextual sub menul ss 34 6 18 3 TEQ Tissue Equalisation Extra B tools contextual sub menu 34 6 18 4 High Resolution Extra B tools contextual SUB MENU eee ee 35 6 19 DisPLAY SIZE CONTEXT
71. Radial Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Right Radial Artery Right Radial Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Left Ext lliac Artery Left Exterior Iliac Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Right Ext lliac Artery Version 3 du 16 07 2012 Right Exterior Iliac Artery R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Page 169 sur 173 BECM Noveko APPLICATION VASCULAR Mode PW Abbreviation Organ Measure tool Manual Acceleration Acceleration Left Com Femoral Artery Left Common Femoral Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Right Com Femoral Artery Right Common Femoral Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Left Profonda Arte
72. Review menu appears on the screen Exit of the Review mode by clicking Review once again and return to the previously used imaging mode 14 3 1 Multiview Display of all stored images as miniatures on the screen when pressing Multiview Possibility to select one or several images for printing or viewing by ticking the corresponding boxes Selection of all images by pressing Select all To de select press Disable all Print by 6 Printing of 6 images per page Print by 8 Printing of 8 images per page View Display of selected images Press Clear or click on the cross to exit the View Click on the arrow to go from one page to the next Press Clear to exit the Multiview 14 3 2 Selection To select an image or a sequence pass the cursor with the trackball on the names in the list in the second column The names will now be highlighted successively in blue A thumbnail of the selected image or sequence is displayed below the list Press Select with the left button on the name in the list to load the image or the sequence immediately Press Select with the right button on the name in the list to select the image or the sequence without loading it in order to use the functions in the contextual Review menu 14 3 3 Load To select an image or a sequence pass the cursor with the trackball on the names in the list in the second column The names will now be highlighted successively in blue and a thumbnail of the selected image or sequence is disp
73. Schaffer IPDS 1998 11th Congress of the International Perinatal Doppler Society Umbilical artery RI Schaffer JOURNAL F R FERTILTAT UND REPRODUKTION July 2 4 1998 R Mai P Kristen A Rempen Farb Dopplersonographisme Normalwerte in der Schwangershaft Z Mai Geburish u Perinat P 221 222 R Mai P Kristen A Rempen Farb Dopplersonographisme Normalwerte in der Schwangershaft Z Schaffer Geburish u Perinat P 221 222 R Mai P Kristen A Rempen Farb Dopplersonographisme Normalwerte in der Schwangershaft Z Mai Geburish u Perinat P 221 222 NB The obstetrical tables Chitty drvd are made to be used with a circumference calculated from two measured diameters The obstetrical tables Chitty Pltd are made to be used with a circumference measured as an ellipse It is thus recommended in case of using the Chitty tables to choose the Pltd version FG PW ical artery RI ical artery PI ical artery PI Precisions on GA dating The values used by the software might present minor differences compared to the values published by the authors because of procedures used for representing the digital data These differences generate minimal margins of error cf below which are added to the margins of error indicated by the authors For all the tables Margin of error GA 1 day Table BPD Hansmann Margin of error GA 2 days Table Tokyo Okai Mai Schaffer Margin of error has not been pr cised the use of these table
74. See chapter 6 1 Frequency See chapter 6 2 Gain See chapter 6 3 TGC See chapter 6 4 Focus and Focus Gap See chapter 6 5 Power See chapter 6 13 Dynamic See chapter 6 7 Ima Level See chapter 6 16 Gamma See chapter 6 17 Extra B tools See chapter 6 18 Display Size See chapter 6 19 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 37 sur 173 BECM Noveko 8 CFM Mode imaging Key number 5 Activation of the CFM mode Color Flow Mapping by pressing the CFM knob The CFM image is added to the B image B CFM Display of the contextual CFM menu Display of the CFM box The curser is trapped in the CFM box for adjustment of size and position The mode CFM velocity is activated by default The following CFM parameters are always displayed on the screen in the middle right part Mode Gain Frequency Power PRF The other parameters are displayed when they are changed In order not to encumber the screen these other parameters swap place on a First in First Out basis During the change of each parameter the changed value is displayed in yellow Deactivation of the CFM mode by pressing the CFM knob or the B knob 8 1 CFM Modes Two CFM modes are available Velocity and Power The mode CFM velocity is activated by default The active CFM mode is displayed on the screen To change from one CFM mode to another click on the key CFM Mode in the contextual CFM menu 8 1 1 Velocity Contex
75. Selection empties the column with selected elements and enables to make a new choice After exporting the patient files reports images sequences and graphs can be opened and reviewed on external computers or other Imagyne devices The control Refresh updates the connected external media Delete Follow the above described procedure Instead of inserting an external media and clicking Export click Delete A confirmation message occurs for security reasons in order not to delete by mistake Click OK to confirm and delete Import Possibility to import patient files as well as images and sequences in raw data format imagenv clipenv The upper part of the screen contains three columns The one to the left named Drive contains the list of connected external media and their file content To see all elements click on the successive crosses The column named File lists the elements of each highlighted file Select the wanted element in the first or the second column Click on the grey button in the middle marked with gt gt The selected elements are now listed in the third column Selection to Import Click Import If the data is not suited for import bad format an error message occurs Otherwise the selected element is copied from the external media to the scanner s hard disk and can be reviewed The control Clear Selection empties the column with selected elements and enables to make a new choice The control Refresh
76. Sys Systole speed VDias Diastole speed VAVG Average speed 15 3 4 Rate Contextual menu Click on the key Rate in the contextual measure menu to activate the measure of the rate The device is automatically selecting the maximum number of complete cycles available in the PW specter indicated by a white horizontal line To adjust the number of cycles place the trackball on either the left or the right marker in the PW specter and click Select left or right button After adjustment of one marker click Select with the right button to pass form one marker to the other The active marker is white Validation of the new position by the left Select button The result of the rate measurement is displayed at the bottom left corner of the screen 15 3 5 Flow Contextual menu Click on the key Flow in the contextual measure menu to activate the measure of the Flow If the baseline is not centered an error message will occur Center the baseline see chapter 9 8 in order to make the measurement The result of the flow measurement is displayed at the bottom left corner of the screen 15 3 6 Arrow Contextual menu See chapter 15 1 5 NB In PW and B CFM PW Modes arrows can only be positioned on the PW specter Maximum 5 arrows 15 3 7 Annotation Contextual menu See chapter 15 1 6 NB In PW and B CFM PW Modes annotations can only be positioned on the PW specter 10 annotations can be placed on one image 15 3 8 Select Conte
77. The thumbnail stays on the screen during the current application The image can be loaded by clicking on the thumbnail with the trackball and Select If several images and sequences of the same application are stored these are all displayed by thumbnails above the contextual menu By clicking on the arrows at the left and or the right all thumbnails of stored images and sequences during the current application can be viewed If a previously stored image is reloaded and modified it can be stored again If the image was previously linked to a patient file at the moment of the new storing the device will ask if the image should be stored in the same directory When you click Yes the modified image will be stored in the same directory If you click No the image will be stored as a non attached file 14 2 Store clip Key number 21 A frozen sequence can be stored on the hard disk by clicking the key Store clip Key number 21 While storing the following message is displayed on the screen Sequence recording A small clock appears in the Cineloop window with the message Cine saving Don t press any key before these messages disappear Store clip is active in Freeze mode See chapter 13 The choice of the sequence format avi and or Dicom is made in the Setting menu See chapter 5 4 By default the raw data format is always stored env The length of the sequence for storing can be reduced in order to store only the most important par
78. UAL MENU 35 6 19 1 Orientation of image Display Size contextual sub menu 35 6 19 2 FOV Field of View Display Size contextual sub menu see e e 35 6 19 3 Trapezoidal image Display Size contextual sub oenul 35 6 20 ECG LCE Riu ER 6 20 1 aace EE ME 35 6 20 2 ECG time ECG submenul csenneeeesseenes 35 6 20 3 ECG Smoothing ECG sub menu ss eee 35 6 21 HARMONIC KEY NUMBER 29 ccessccssecessceessecessseessecsssecsssecesssecssecsesessnsecssesensecsusessnsecessesenseceaseeeaseceasesenseses 36 7 M MODE IMAGING KEY NUMBER 320 cscssscssssscssssscssssscssscssssessscsscsesenssscsncssccasseecsasencsasensessees 37 7L POSITIONING OF THE M OI 37 7 2 TIME SCALE CONTEXTUAL MENU eegne doe rete ei o EHE P ae Ere EE eee E Re ORC EROR a ee E ee iod 37 7 3 COLOR EXTRA BM TOOLS SUB MENU enne eene nennen erre enter rns n nens er rn se tenerse enne r nn senes nnn 37 7A B MODE CONTROUS weiss M 37 8 CFM MODE IMAGING KEY NUMBER B csccsscssssssssssscsssencssscosssscssseccsasensssceacsscsasesecsasencsasensessees 38 8 LORM IM ODES ers EE 38 8 1 1 Velocity Contextual MENU gt secccsicsnsicsscsecsessecnscesenseoseveiesssosaatnevesdobesvevesssstenedsecdesdeined e So ege ERO Es PEE aay 38 8 1 1 1 Invert Contextualmentu i tic tt tte rt acest E nie C eset Ee esee YE Cen E ERR CERE ER eee PA E EAS 38 8 1 2 CFM Power Contextual menu 38 8 1 2 1 Power scale
79. al commercial or hospital environment of the Imagyne equipment NOTE 1 UT is the a c mains voltage prior to application of the test level hypoechogenic and hyperechogenic targets that should stay visible without any possible confusion NOTE 2 The use of cables or accessories different from those specified by ECM may have as a consequence an increase of emission or a decrease of immunity NOTE 3 The essential performance of the equipment considered for the compliance to the standard is defined as the correct visualization on the screen of an area of interest centered at 5 cm s depth with the C360 probe using default settings on a ATS model 539 phantom The ultrasound image includes both Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 89 sur 173 BECM Noveko TABLE 4 Guidance and manufacturer s declaration electromagnetic immunity The Imagyne equipment is intended for use in the electromagnetic environment specified below The customer or the user of the Imagyne equipment should assure that it used in such an environment Compliance Immunity test IEC 60601 test level aval Electromagnetic environnement guidance eve Portable and mobile RF communications equipment should be used no closer to any part of the Imagyne equipment including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitte
80. al menu See chapter 15 1 2 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 60 sur 173 BECM Noveko 15 5 3 Trace Contextual menu See chapter 15 1 3 15 5 4 Arrow Contextual menu See chapter 15 1 5 15 5 5 Annotation Contextual menu See chapter 15 1 6 15 5 6 Select Contextual menu See chapter 15 1 7 15 5 7 Print Contextual menu See chapter 15 1 8 15 5 8 Delete Contextual menu See chapter 15 1 9 15 5 9 Delete all Contextual menu See chapter 15 1 10 Exit of the Measure mode and return to Freeze mode by pressing the key Measure Exit of the Measure mode and return to live imaging by pressing the key Freeze Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 61 sur 173 BECM Noveko 16 Post processing Post processing controls are available on cine loop images and sequences see chapter 13 about the Freeze and Cineloop mode as well as on stored and loaded images and sequences see chapter 14 16 1 B Mode In B mode the following controls are available for post processing 16 1 1 B controls Gain See chapter 6 3 TGC See chapter 6 4 Zoom See chapter 6 6 Dynamic See chapter 6 7 Noise Reject See chapter 6 8 Ima View See chapter 6 10 Gamma See chapter 6 17 ImaClean See chapter 6 14 Ima Level See chapter 6 16 Color See chapter 6 18 2 Anatomic M This function can both be activated and adjusted in post pr
81. all Validation of the position by the Select button left or right Draw the form of the trace with the trackball and join the first spot Click on the right Select button to pass from one spot to another or drag the trackball in order to adjust the form of the trace The active spot is white Click the left Select button to validate To reposition the whole trace click in the middle of the trace and drag it with the trackball Validation of the new position by the left Select button The result of the trace measurement Circumference and Surface is displayed at the bottom left corner of the screen One trace measurement is available on one image 15 1 4 Measures in B Dual Mode 15 1 4 1 Volume Contextual menu Click on the key Volume in the contextual B Dual Measure menu with the Select button to activate a volume measurement composed of an ellipse and a distance measurement An ellipse will appear on one of the images a distance on the other The ellipse is composed of three markers and several small spots Click on one of the markers and place it at the wanted place with the trackball Validation of the position by the Select button left or right Draw the size of the ellipse with the trackball Click on the right Select button to pass from one marker to another in order to adjust the form and the size of the ellipse The active marker is white Click the left Select button to validate To reposition the whole ellipse click on one of the small s
82. and receiving at the double frequency harmonic frequency The Pulse Inversion Harmonic is active on all probes 5 frequency steps are available on each probe in Harmonic imaging When the function is active Harmonic On is displayed on the screen in the upper right corner Deactivation of the Harmonic function by pressing the key Harmonic Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 36 sur 173 BECM Noveko 7 M Mode imaging Key number 30 Selection of the M mode by clicking the M key The M mode is added to the B image Display of the contextual M menu 2 levels Deactivation of the M mode by clicking the M key or the B knob 7 1 Positioning of the M line When turning the M mode on the M line is positioned in the middle of the B image If the line is not at the wanted place place the curser at the wanted place with the trackball and click Select to validate the new position 7 2 Time scale Contextual menu Increase and decrease of the time scale by the keys TimeScale and TimeScale in the contextual M menu The time scale goes from 4 to 26 seconds The scale in seconds is updated 7 3 Color Extra BM Tools sub menu Pseudo coloration of the M representation and the B image by pressing the keys Color and Color in the Extra BM tools contextual sub menu 5 color steps are available 7 4 B Mode controls The following adjustments of the B image stay active also in the M Mode Depth
83. ansducer If you find any damage do not use the probe until it has been inspected and either repaired or replaced by an authorized ECM customer service engineer Warning Any crack or damage to the probe head can lead to electrical shock Never use a probe that is damaged that has been dropped or has been suffering a severe collision until it has been inspected by an ECM customer service engineer In case of failure or replacement of a probe the damaged probe must be recycled Take care of bringing the probe to a certified recycling center or return it to the distributor The distributor s address is found on the first page of this manual Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 16 sur 173 BECM Noveko 2 8 3 Handling of probes Warning The probe is fragile and requires proper handling care and cleaning Transducer care includes daily inspections cleaning and disinfections between each patient Please refer to chapter 22 2 about how to perform proper care to the probe gt Warning Always place the probe in the probe holder placed on the keyboard or in another secured place when not used in order to avoid it from falling either on the patient or on the floor Any crack or damage to the probe head can lead to electrical shock Never use a probe that is damaged that has been dropped or has been suffering a severe collision until it has been inspected by an ECM customer service engineer gt
84. arker Place it at the wanted place on the CW specter with the trackball and validate by the Select button left or right Place the second marker with the trackball at the wanted place Click on the right Select button to pass from one marker to another in order to adjust the acceleration measurement The active marker is white Click on the left Select button to validate The result of the acceleration measurement is displayed at the bottom left corner of the screen 15 4 4 Arrow Contextual menu See chapter 15 1 5 NB In CW mode arrows can only be positioned on the CW specter Maximum 5 arrows 15 4 5 Annotation Contextual menu See chapter 15 1 6 NB CW mode annotations can only be positioned on the CW specter 10 annotations can be placed on one image 15 4 6 Select Contextual menu See chapter 15 1 7 15 4 7 Print See chapter 15 1 8 15 4 8 Delete Contextual menu See chapter 15 1 9 15 4 9 Delete all Contextual menu See chapter 15 1 10 Exit of the Measure mode and return to Freeze mode by pressing the key Measure Exit of the Measure mode and return to live imaging by pressing the key Freeze 15 5 Measures in 4D Measurements can be made on 4D images in the multi cut display see chapter 12 3 4 15 5 1 Distance Contextual menu When turning on the measure mode the curser appears automatically in the middle of the image ready for measuring the first distance See chapter 15 1 1 15 5 2 Ellipse Contextu
85. ate the GA when ticking the box The calculation of GA replaces the display of percentiles Import Export Archive Export Possibility to export patient files reports images clips sequences and graphs to an external media The upper part of the screen contains three columns The one to the left named Directory contains the list of images and clips sequences which are not attached to a patient file as well as the list of patients To see the full list of patients click on the cross to open the list A patient file can include one or several reports as well as images and sequences The reports can include images sequences and graphs Click on the successive crosses to see all elements The column named File displays the list of images sequences and graphs In this list each image and sequence appears both in the raw data format env and in the computer format which was chosen for storing Select the wanted element in the first or the second column Click on the grey button in the middle marked with gt gt The selected elements are now listed in the third column To export or delete One or more elements can be selected simultaneously by using the alphanumeric keys Shift and Ctrl To export insert a CD or a USB device Click Export to USB or Export to CD The exported files are copied to the external media but not deleted If no external media is available an error message occurs in the bottom of the screen The control Clear
86. ate the volume 12 2 10 Reject Contextual menu Adjustment of the Reject level by the keys Reject and Reject in the contextual 4D menu The updated rejct level is displayed on the right of the screen Min reject 1 Max reject 4 12 2 11 Contrast Contextual menu Adjustment of the contrast level by the keys Contrat and Contrast in the contextual 4D menu The updated contrast level is displayed on the right of the screen Min contrast 0 Max contrast 4 12 2 12 Color contextual menu Adjustment of the color level of the 4D image by pressing Color and Color 3 steps 12 2 13 Dynamic contextual menu See chapter 12 1 3 12 2 14 Gamma contextual menu See chapter 12 1 4 12 2 15 Smoothening contextual menu Smoothening of the 4D volume by the keys Smoothening and Smooothening 5 levels of smoothening 12 3 4D Freeze Press the key Freeze Key number 3 to freeze the 4D imaging Display of the 4D Volume by default Display of the 4D freeze contextual menu Display of the Cine loop window with the number of images and the length of the frozen sequence The curser is trapped by the play indicator by default To unleash the curser from the Cine loop window click Select See the chapter 13 for details on the cine loop In the upper left of the screen a B image is displayed with indication of the position of the 4D box The height of the 4D box clipping can be adjusted by clicking on the upper or the lower line o
87. cking Select on the measure It is now highlighted in blue Click Delete in the left bottom corner to delete the measurement from the report An on going examination can be stopped by clicking Stop examination in the right bottom corner This will close the report and close the patient file Exit of the Report by pressing the key Report or by pressing Clear After visualizing a previously made report it is necessary to click Unselect in the patient page in order to close the patient file Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 77 sur 173 BECM Noveko International Inc 21 Connection of peripherals The Imagyne equipment can be connected to several peripherals like composite video printers USB peripherals flash disk hard disk printer etc another PC through an Ethernet link a specific ECG cable provided by ECM Video output Footswitch ECM exclusively recommends the use of the following cables specific ECG cable provided by ECM ref 31 1994 shielded USB cable version USB 2 0 with 2 ferrites ZCAT2235 1030A shielded Ethernet cable category 6 with 2 ferrites ZCAT2235 1030A shielded video cable equipped with RCA connectors and 2 ferrites ZCAT2235 1030A For using a footswitch consult ECM To ensure the electrical safety of the equipment N WARNING All peripherals requiring a power input printers monitors etc must also use a medical isolation
88. cle is displayed and indicates that the turning is activated Turn around the volume by moving the trackball Click Select to unleash the curser Exploration in depth by turning the Focus know key number 7 Clockwise turning moves up anti clockwise turning moves down 12 3 7 Print contextual menu Printing of the 4D display on the screen by pressing the key Print Multicut by default Cube or Volume 12 3 8 Smoothening contextual menu See chapter 12 2 15 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 49 sur 173 BECM Noveko 12 3 9 Opacity Key number 5 See chapter 12 2 6 12 3 10 Luminosity Key number 6 See chapter 12 2 7 12 3 11 Reject Contextual menu See chapter 12 2 10 12 3 12 Contrast Contextual menu See chapter 12 2 11 12 3 13 Color contextual menu See chapter 12 2 12 12 3 14 Dynamic contextual menu See chapter 12 1 3 12 3 15 Gamma contextual menu See chapter 12 1 4 Defreeze and return to live imaging by pressing the key Freeze Key number 3 Exit of 4D imaging and return to 2D imaging by pressing the B knob Key number 4 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 50 sur 173 BECM Noveko 13 Freeze mode Cineloop Freeze and defreeze of the image by the Freeze key Key number 3 The last sequence of images is stored in the cineloop The freeze mode is available in all modes B M CFM PW Triplex
89. cm 154 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 96 sur 173 BECM Noveko Probe model C360R Mode PW TIS TIB Index label MI Non scan TIC Scan Non scan Aaprt lt 1 cm Aaprt gt 1 cm Maximum Index Value 0 45 0 61 1 14 a pra MPa 0 80 P mW 73 a Min PB zs Ita 2 zs 41 zs cm 2 6 zbp cm 2 6 Associated acoustic zb cm 6 5 6 5 parameters z at max lpi cm 8 deq zb cm fawf MHz 3 11 3 11 3 11 a Dim Aaprt X 21 21 a Y 11 11 a td us 1 77 prr Hz 5120 Other information pr at max Ipi 1 89 deq at max Ipi cm Ipa Bl at max MI W cm 20 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 97 sur 173 BECM Noveko Probe model L738P Mode B mode 2D TIS TIB Index label MI Non scan Non TIC can 2 2 Aaprt lt icm Aaprt 1cm scan Maximum Index Value 1 06 0 51 a Pra MPa 3 0 P mW 13 a Minis a ple D cm Zbp cm Associated acoustic Zb cm parameters z at max loi cm 3 deql b cm fawf MHz 7 96 7 96 a Dim Aprt X 0 9 a Y 43 a ty us 0 16 prr Hz 64 Other information Dr at max lei 6 83 deq at max lpi cm La at max MI W cm 371 Probe model L738P Mode CFM TIS
90. cuts The lines on the images can be dragged with the trackball from one side to another in order to see the whole capture of all three sides These adjustments also affect the Cube display 12 3 4 Cube contextual menu Display of the 4D image break down as a three dimensional cube The colors on the cube are the same as in the Multicut display Red illustrates the 2D image cut in the line of the probe A Yellow illustrates the image cut vertically perpendicular to the probe Blue illustrates the image cut horizontally perpendicular to the probe The axes of the cube can be moved with the trackball in order to see the whole capture of all three sides These adjustments also affect the Multicut display 12 3 5 Slanting cut contextual menu Possibility to extract a selected cut in any spatial orientation by clicking Select and dragging each of the four handles yellow red blue and green To validate the position of a handle click Select The colors of the handles are the same as in the Multicut and Cube displays Red illustrates the 2D image cut in the line of the probe A Yellow illustrates the image cut vertically perpendicular to the probe Blue illustrates the image cut horizontally perpendicular to the probe The green handle enables to turn the image in any direction and seek the wanted cut 12 3 6 Explorer 3D Contextual menu Possibility to turn around the acquired volume Press Select in the cube on the right A pink cir
91. e Surface Stenosis Distance Stenosis Surface Distance Surface Stenosis Distance Stenosis Surface Distance Surface Stenosis Distance Stenosis Surface Distance Surface Stenosis Distance Stenosis Surface Distance Surface Stenosis Distance Stenosis Surface Distance Surface Stenosis Distance Stenosis Surface Distance Surface Stenosis Distance Stenosis Surface Distance Surface Stenosis Distance Stenosis Surface Distance Surface Stenosis Distance Stenosis Surface Distance Surface Stenosis Distance Stenosis Surface Distance Surface R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 165 sur 173 BECM Noveko APPLICATION VASCULAR B CFM Abbreviation Organ Measure tool Stenosis Distance Stenosis Surface Right DP Artery Right Dorsalis Pedis Artery Distance Surface Stenosis Distance Stenosis Surface Left SFA Artery Left Superficial Femoral Artery Distance Surface Stenosis Distance Stenosis Surface Right SFA Artery Right Superficial Femoral Artery Distance Surface Stenosis Distance Stenosis Surface Left AT Artery Left Anterior Tibial Artery Distance Surface Stenosis Distance Stenosis Surface Right AT Artery Right Anterior Tibial Artery Distance Surface Stenosis Distance Stenosis Surface Left PT Artery Left Posterior Tibial Artery Distance Surface Stenos
92. e chapter 15 1 5 NB In M Mode arrows can only be positioned on the M specter Maximum 5 arrows 15 2 4 Annotation Contextual menu See chapter 15 1 6 NB In M Mode annotations can only be positioned on the M specter 10 annotations can be placed on one image Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 57 sur 173 BECM Noveko 15 2 5 Select Contextual menu See chapter 15 1 7 15 2 6 Print See chapter 15 1 8 15 2 7 Delete Contextual menu See chapter 15 1 9 15 2 8 Delete all Contextual menu See chapter 15 1 10 Exit of the Measure mode and return to Freeze mode by pressing the key Measure Exit of the Measure mode and return to live imaging by pressing the key Freeze 15 3 Measures in PW and B CFM PW 15 3 1 Automatic measure Contextual menu When turning on the measure mode in PW B CFM PW Triplex mode the automatic measurement appears directly on the PW specter with the results of the following calculations displayed at the bottom left corner of the screen Rate RI Resistance Index S D Systole Diastole PI Pulsatility Index If the angle correction see chapter 9 7 is added either during the examination on live images or during post processing see chapter 16 3 2 the results of the following calculations appear below the others at the bottom left corner of the screen VSys Systole speed V Dias Diastole speed VAVG Average speed The de
93. e of the screen in the part concerning the printers click on Settings The Sony UP D897 printer should be the Default printer Click on Properties In the thumbnail Layout Select Enlarge to paper with Scale 100 96 NB These parameters should only be adjusted in the thumbnail Layout The parameter Enlarge to paper in the thumbnail Settings should not be selected Printing parameters for reports Continued mode or manually This adjustment is made in the Setting menu of Imagyne Press the key Setting on Imagyne In the box named Report Printing on thermal printer tick the box USB and select the wanted page delay From 0 to 5 seconds between each page Manually In this case a message occurs after each printed page in order for the operator to cut each page This parameter enables to print correctly on a thermal SONY UP D897 printer Tick the corresponding box if you want to draw a frame border around each page NB The result of printing on other thermal printers than SONY UP D897 cannot be guaranteed Adjustment of the brightness on the printer itself can improve the readability especially for the graphs in grey shades Adjustment of the sharpness on the printer itself can also improve the printing result If 2 USB connected printers thermal and PC are installed on the same Imagyne device Each time when shifting from one printer to another it is recommended to check that the printing parameter adjustments of
94. e overall image is adjusted by turning the B knob Turn the B knob clockwise to increase the Gain Turn the B knob anticlockwise to decrease the Gain The updated gain level is displayed on the right of the screen Min gain 0 Max gain 255 6 4 TGC Time gain control Keys number 24 The gain can be adjusted in selected depth zones by the 6 TGC rocker switches Each zone is displayed by a blue dot on the TGC curve on the left of the screen The zones are available depending on the depth Switch to the right to increase the TGC Switch to the left to decrease the TGC You can also adjust the TGC by placing the curser at the wanted place at the TGC curve Press Select to validate the new TGC Click on the Reset TGC key in the contextual B menu to return to the predefined TGC curve 6 5 Focus Key number 7 The Imagyne device is handling from 1 to 4 emission focuses Increase and decrease of the number of focuses by clicking the Focus knob Every click increases the number of active focuses until 4 by the following click only one focus is active Place the focus es on the depth scale of the image by turning the Focus knob Turn the Focus knob anticlockwise to place the focus es lower at the image Turn the focus knob clockwise to place the focus es higher at the image The distribution of focuses along the depth of the image is predefined The updated focuses are shown on the right of the screen where one or more triangular markers ind
95. e s screen contextual menu or report menu Selection of the delay between each printed page of the report when printing on thermal printer Options from 0 to 5 seconds or Manual When the box is ticked a border is drawn at the separation of each page See chapter 21 2 for details about printing reports on USB connected thermal printers Upgrade Possibility to upgrade the software with a support provided by ECM Insert the ECM upgrade CD in the CD drive press Upgrade The device asks you to restart Imagyne Click OK The system shuts down automatically Wait 20 seconds before restarting the device The system is now upgraded and the new software number is displayed Printer Add Printer Adding of a printer PC printer or USB connected thermal printer with the use of the printer driver launching of the installation assistant Several printers can be installed It is recommended to switch off the device and restart it between each printer installation Default Printer Selection of default printer when several printers are installed Select Printer at print image When several printers are installed selection of printer at each print when ticking the box Otherwise use of default printer at each print DICOM settings Access to DICOM settings for printing Storage and Worklist Exit by pressing Clear User protocols and annotations User protocols The upper half of the window allows each user to make an individual choice of tables measure
96. e ultrasound scanner is designed to be used in an environment as defined on the figure below 2 5 m 1 5m i 2 6 Electromagnetic compatibility The Imagyne ultrasound scanner is compliant with the standard EN 60601 1 2 concerning electromagnetic compatibility EMC Warning The Imagyne ultrasound scanner is a medical electrical device which needs special care regarding the EMC The equipment should be installed and started by a trained person according to the detailed information in this manual refer to annex II Warning Portable communication equipments can affect the normal function of the Imagyne equipment refer to table 6 of annex II Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 14 sur 173 ECM Noveko gt Warning The use of cables or accessories others than those specified by ECM may result in an increase of emission or a reduction of immunity of the Imagyne device refer to paragraph 20 peripherals gt Warning The equipment should not be used close to other equipments and if it is not possible to do differently the functioning of the Imagyne device should be monitored in order to check that it is working normally 2 7 Probe and equipment compatibility The probes supplied with the Imagyne equipment are intended to be used only with this system gt Warning Never try to connect the supplied probes to any other ultrasound system This can lead to irreversible da
97. e was frozen during the selection of application and preset it is necessary to unfreeze the device by clicking Freeze before having access to the new loaded application and preset with a live B image After unfreezing same procedure as described above 17 2 2 Create a new preset To create a preset the parameters and controls should be adjusted as a start See the chapters according to each mode and available controls for details When the adjustments are satisfying press Preset Key number 33 Choose the wanted application in the displayed list and click Select Click on the key New in the contextual Preset menu A window appears in the preset column with the curser ready for entering the name of the new Preset with the alphanumeric keyboard After entering the name of the new preset validation of the name by clicking Enter on the alphanumeric keyboard or by clicking Select The new preset is stored in the device The device returns to the imaging mode with the new preset loaded Each user can create as many presets he wants 17 2 3 Rename a preset Activation of the list of applications and presets by clicking the key Preset Key number 33 The available applications are displayed on the upper left of the screen Pass the curser on the list of applications and Press Select right or left button on the wanted application in which the preset should be renamed Afterwards press Select with the right button on the preset that should be renamed
98. eased 8 13 B Mode controls The following adjustments of the B image stay active in the B CFM Mode Gain TGC Depth Please refer to the chapter 6 for further details of the B Mode controls Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 40 sur 173 BECM Noveko 9 PW Mode imaging Key number 6 Activation of the PW Pulsed Wave mode by pressing the PW knob The PW image is added to the B image B PW Display of the contextual PW menu 2 levels Display of the PW fire line and gate on the B image and of the graphicillustration of the PW spectrum on a timescale The curser is trapped on the gate for adjustment of size and position The following PW parameters are always displayed on the screen in the lower right part Gain Frequency Power PRF The other parameters are displayed when they are changed In order not to encumber the screen these other parameters swap place on a First in First Out basis During the change of each parameter the changed value is displayed in yellow Deactivation of the PW mode by pressing the PW knob or the B knob 9 1 Positioning and size of the PW gate The PW gate line can be moved with the trackball to the wanted place immediately after turning on the PW mode The gate line is white when the repositioning is activated To adjust the gate size click Select with the right button The PW gate line is a white dotted line when the adjustment of the gate size i
99. ed Manual Acceleration Acceleration time Acceleration Mitral valve Time Speed Manual Acceleration Acceleration time Acceleration Tricuspid valve Time Speed Manual Acceleration Acceleration time Acceleration Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 155 sur 173 BECM Noveko APPLICATION CARDIOLOGY Mode Anatomic M Measure tool Measurement Result Heart Rate Rate Teichholz Diastole EDV Systole ESV Stroke volume Cardiac output Ejection fraction Teichholz Cross Section Diastole EDV Systole ESV RV Diameter Stroke volume Cardiac output Ejection fraction Cube Cross section Diastole EDV Systole ESV RV Diameter Stroke volume Cardiac output Ejection fraction Gibson Cross Section Systole EDV Diastole ESV RV Diameter Stroke volume Cardiac output Ejection fraction APPLICATION CARDIOLOGY Mode M Organ Measure tool Measurement Result Heart Rate Rate Teichholz Diastole EDV Systole ESV Stroke volume Cardiac output Ejection fraction Body Surface Area Area Time Time Aortic valve Heart rate Rate Time Time Pulmonary valve Heart rate Rate Time Time Mitral valve Heart rate Rate Time Time Tricuspid valve Heart rate Rate Time Time Version 3 d
100. ed and remade See chapter 16 7 about post processing 18 1 How to make a protocol measurement In the Preset menu select the wanted application and preset Select the imaging mode B M CFM PW CW Press Protocol The available protocol calculations are displayed in a list in the window on the left of the screen When passing the curser on the list the protocol calculations are highlighted successively To load a protocol calculation click Select The measurement tool is ready on the image The curser is trapped by the first marker of the measurement Place the first marker at the wanted place with the trackball Validation of the position by the Select button left or right Place the second marker with the trackball at the wanted place Click on the right Select button to pass from one marker to another in order to adjust the measurement The active marker is white Click the left Select button to validate To reposition the whole measurement click on one of the small spots and drag the measurement with the trackball Validation of the new position by the left Select button The result of the measure is displayed on the screen The image with the measurement and the abbreviation of the protocol calculation can be stored or printed 18 1 1 Protocol measurements with groups In some modes in all applications for instance PW and CW the protocols are grouped for instance by organs In the Preset menu select the wanted application and pr
101. ed information provided by the equipment is only indicative The equipment is performing an accurate measurement of the Doppler frequency shift but speed indication is obtained by a computation based on the angle correction information which is manually entered by the user As an indication only the speed information would be accurate at 596 of the full scale speed in the hypothetical case where there would be absolutely no uncertainty on the angle correction estimation Note 2 The IMT measurement is only indicative The measure accuracy shown in the table above is not applicable Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 87 sur 173 BECM Noveko 25 Annex Il Electromagnetical compatibility TABLE 1 Guidance and manufacturer s declaration electromagnetic emissions The Imagyne equipment is intended for use in the electromagnetic environment specified below The customer or the user of the Imagyne equipment should assure that it used in such an environment CEI 61000 3 3 Emission tests Compliance Electromagnetic environment guidance REE MIS The Imagyne equipment uses RF energy only for its internal function Therefore its RF missions EE Group 1 emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions Class A CISPR 11 The Imagyne equipment is suitable for use in all establishments other than
102. ed with synthetic material the relative humidity should be at least 3096 Electrical fast transient burst 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment IEC 61000 4 4 Surge 1 kV differential mode 1 kV differential mode Mains power quality should be that of a IEC 61000 4 5 2 kV common mode 2 kV common mode typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 96 UT gt 95 dip de UT for 0 5 cycle 40 UT 60 6 dip de UT for 5 cycles 7096 UT 30 96 dip de UT for 25 cycles 5 96 UT gt 95 dip de UT for 5 s 596 UT gt 95 dip de UT for 0 5 cycle 40 UT 60 dip de UT for 5 cycles 70 UT 30 dip de UT for 25 cycles 596 UT gt 95 dip de UT for5s Mains power quality should be that of a typical commercial or hospital environment If the user of the Imagyne equipment requires continued operation during power mains interruptions it is recommended for the Imagyne equipment to be powered from an uninterruptible power supply Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typic
103. eering Upwards activation steers to the left downwards activation steers to the right NB Steering is only possible when using the linear probe 10 2 CFM mode controls The following adjustments of the CFM image stay active in the B CFM PW mode Gain Reject Please refer to chapter 8 for details 10 3 B mode controls The following adjustments of the B image stay active in the B CFM PW Mode Gain TGC Please refer to the chapter 6 for further details of the B Mode controls 10 4 Simplex Triplex Contextual menu Activation of the Simplex mode where only the PW is live by the key Simplex in the contextual B CFM PW menu The B CFM image is frozen and the PW Doppler quality is improved The key Triplex appears in the contextual B CFM PW menu and enables to deactivate the Simplex mode and return to Triplex mode Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 44 sur 173 BECM Noveko 11 CW mode imaging Activation of the pre CW Continuous Wave mode in two ways Directly by pressing the PW knob if the box PW starts CW is ticked in the Setting page see chapter 5 4 Or by pressing the key CW in the contextual B menu Display of the CW line on the B image The CW image is added to the B image The curser is trapped on the line for adjustment of position After adjusting the position press the Left Select button for activating the CW mode Display of the graphic illustration of the CW spec
104. en Min dynamic 20 dB Max dynamic 90 dB 2 dB step 6 8 Noise Reject Contextual menu Activation of the function Noise Reject by pressing the key Noise Reject in the contextual B menu The key is highlighted in red when this function is active The Noise Reject box appears on the image and can be positioned on the wanted place by dragging the trackball To validate the position and unleash the cursor click Select To reactivate the positioning of the Noise Reject box click Select inside the box To adjust the size of the Noise Reject box click on one of the sides of the box with the Left Select button and move the trackball Click Right Select to move from one side to another for adjusting the size Click Left Select to validate the size The adjustment of the Noise Reject is made by turning the Zoom button Key number 8 Turn it clockwise to increase the noise reject and turn it anti clockwise to reduce the noise reject Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 32 sur 173 BECM Noveko Click on the key Noise Reject to deactivate this function and remove the Noise reject box 6 9 Ima Cross Contextual menu Activation of the imaging mode Ima Cross by the key Ima Cross in the contextual B mode When the function is active the key is highlighted in red The device is firing with several crossed beams The angle of the beams is displayed on the screen and can be adjusted by the alphanumeric keys
105. ent of luminosity in 4D mode by turning 12 7 Focus Increase and decrease of the number of focuses in B mode by pressing 6 5 Positioning of focuses by turning Depth exploration by turning in 4D mode Explorer 3D 12 8 Zoom Activation and deactivation by pressing of one of the two zoom modes chosen 6 6 in the Setting menu Increase and decrease of the zoom scale by turning Increase and decrease of the Noise Reject in B mode by turning 6 8 Activation of Rotate function in 4D by pressing rotating by turning 12 9 PRF CFM Increase and decrease of PRF in CFM mode 8 5 10 Reject Increase and decrease of the reject of slow flows noise in CFM mode 8 7 g Activation and adjustment of the steering of the CFM box and the PW gate 8 6 11 Steering line 9 6 12 Angle Activation and adjustment of the angle correction in PW mode 9 7 13 PRF PW Increase and decrease of the PRF in PW mode 9 5 14 Baseline Adjustment of the baseline in PW and CW modes 9 8 11 4 15 Audio Adjustment of the sound level PW and CW sound and acoustic indicators 9 10 16 Depth Increase and decrease of the exploration depth 6 1 6 2 83 17 Frequency Increase and decrease of the frequency in each imaging mode 29 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 23 sur 173 BECM Noveko Access to the selection menu of measurements tables and calculations 18 18 Protocol m e
106. eset Select the wanted imaging mode Press Protocol The available protocol groups marked with are displayed in the list in the window on the left of the screen When passing the curser on the list the protocol groups are highlighted successively To open a group click Select The list of protocol calculations for the opened group is displayed in PW for instance Doppler automatic Doppler Manual and Heart Rate When passing the curser on the list the protocol calculations are highlighted successively To load a protocol calculation click Select The measurement tool is ready on the image See chapter 15 about measures and their use To return from an opened group to the list of available protocol groups click Select in the top of the protocol window at the name of the group The list of protocol groups is now displayed Follow the procedure described above to select a new protocol group and calculation 18 1 2 Protocols in Dual In Dual mode see chapter 6 12 it is possible to make several protocol measurements simultaneously at the same screen display In the Preset menu select the wanted application and preset Activate the Dual mode contextual B menu press Protocol Make the wanted protocol measurement on the first image see chapter 18 1 Repeat the procedure for the wanted protocol measurement on the second image Both images can now be stored and or printed simultaneously 18 1 3 User defined distance In all protocols in B and
107. ew protocol group and calculation 18 6 1 Body Surface Area To obtain the calculation of Body Surface Area and cardiac output a patient file must be opened in cardiology application and Height and Weight of the patient should be added See chapter 19 about patient files 18 6 2 Protocols in cardiology application in B mode Several calculations like Simpson need several measurements Click Left Select to load the first measurement tool for instance diastole volume Draw the contour with the trackball Click Select Left to validate Search the image corresponding to the systole in the cineloop or defreeze and scan before freezing again Click Select Left in the middle left of the screen on the following measurement for instance systole volume to load the measure tool Draw the contour and click Left Select to validate The results and calculations are displayed in the lower left part of the screen 18 6 3 Protocols in cardiology application in Anatomic M mode See chapter 6 15 about how to activate and use the Anatomic M mode This mode can also be activated on a frozen B image directly from the contextual Protocol menu The following measurements are only available on the Anatomic M specter Heart rate Teichholz See chapter 15 3 about how to make measurements in PW mode and chapter 15 4 about measurements in CW mode See the list of the content of the cardiology protocol in chapter 29 18 7 Protocols in Gynecology Same procedure as fo
108. eze Right in the contextual Dual Freeze menu Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 51 sur 173 BECM Noveko 14 Store images and clips Review Images and sequences can be stored on the hard disk and afterwards be loaded reviewed and post processed See the chapter 16 about Post processing for details 14 1 Store image Key number 22 An image live or frozen can be stored on the hard disk by clicking the key Store image Key number 22 While storing the following message is displayed on the screen Image recording Don t press any key before this message disappears Store image is active in both live and Freeze modes See chapter 13 The choice of the image format bmp jpeg and or Dicom for storing is made in the Setting menu See chapter 5 4 By default the raw data format is always stored env If an image is stored while a patient file is open the image will be stored in this file If an examination has been started meaning that a report is open the image is stored in the report see chapter 20 If there is no open patient file the image will be stored as a non attached file When the image has been stored a thumbnail with the temporary name of the image appears above the contextual menu example 1090624 1134 2 for image 09 for the year 06 is the month 24 the date 11 the hour of storing 34 the minute of storing and 2 for the number of images stored at the same time
109. f the box The line gets blue and can be dragged with Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 48 sur 173 BECM Noveko the trackball Click Select right to switch between the upper and the lower line Click Select left to validate the new size 4D images and 4D sequences can be stored on the device s hard disk Afterwards they can be loaded reviewed and post processed See chapter 14 and 16 for further details Defreeze and return to live imaging by pressing the key Freeze Key number 3 12 3 1 Rotate Key number 8 Activation of the rotating function by pressing the Zoom knob key number 8 A white circle around the volume image indicates that the rotating is active Turn the Zoom knob to rotate the volume 12 3 2 Volume contextual menu Display of the reconstituted 4D volume image 12 3 3 Multicut contextual menu Display of the 4D image break down 3 cuts and the reconstituted 4D volume image are displayed simultaneously The 3 cuts are the following A2D image cut in the same line as the probe illustrated by the red face of the mini cube and the red lines on the images Animage vertically perpendicular to the probe illustrated by the yellow face of the mini cube and the yellow line on the images A horizontal image horizontally perpendicular to the probe illustrated by the blue face of the mini cube and the blue line on the images The 3 images enable to analyze the different
110. f the device and compromise proper operation of the system 2 4 Electrical safety This equipment is compliant with IEC standard 60601 1 Safety for Medical Electrical Equipment According to the standard the equipment is classified as a According to the type of protection against electrical shock Class equipment b According to the degree of protection against electrical shock Type BF c According to the degree of protection against harmful water ingress IPXO device without protection against water ingress d According to the degree of safety of application in presence of flammable anaesthetic mixture with air oxygen or nitrous oxide Device not suitable for use in the presence of a flammable anaesthetic mixture with air oxygen or nitrous oxide e According to the mode of operation Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 12 sur 173 BECM Noveko Continuous operation In order to ensure patient safety please observe these warnings E Warning The equipment must be maintained in the exact same configuration as it was delivered by ECM It is forbidden to bring any change to the equipment without permission of ECM gt Warning The equipment must be supplied by using the provided power cord including a connection to ground gt Warning All connected peripherals requiring power printer monitor USB peripherals or others must use an insulation transformer or
111. faces and casings of the device off to remove any traces of coupling gel 2 Switch off and disconnect the device together with all connected peripherals 3 Wipe the keyboard and the external surfaces and casings of the device with a clean soft cloth damped in a solution of mild soap and water 4 Follow carefully instructions for low level disinfection indicated by the disinfectant manufacturer Remove any cleaning solution residue with a clean soft cloth damped in sterile water 6 Airdry or dry with a soft clean and dry cloth Mi N WARNING Before proceeding to any cleaning of the equipment check that the system is switched off and all electrical connections and peripherals are unplugged N WARNING Do not use alcohol or other strong chemicals agents that may damage the casings of the equipment Do not poor or spray liquids directly on the equipment 22 2 Cleaning and disinfection of probes 22 2 1 External probes External probes have a low infection risk This risk level corresponds to the use of so called non critical medical devices which means devices which are not in direct contact with the patient or which are in contact with intact skin The needed treatment for this type of medical device is a low level disinfection especially bactericidal Low level disinfection procedure The probes supplied with the Imagyne device must be used only on intact skin The following disinfection solutions have been tested and their compatibil
112. ger Verlag New York P 431 Chitty L S Altman D G Charts of Fetal Size 2 Head Measurements B CFM Chitty British Journal of Obstetrics amp Gynaecology jan 1994 vol 101 P 35 43 Hansmann M Hackel er B Staudach A Ultrasound Diagnosis in Obstetrics and Gynecology Springer Verlag 1990 B CFM Hansmann ISBN 0 387 15348 9 Springer Verlag New York P 431 Biometry 2000 Fetal growth charts by the Coll ge Fran ais d Echographie Foetale CFEF the French College of Fetal Ultrasonography and INSERM U 155 B CFM CFEF Gynecol Obstet Fertil 2000 Jun 28 6 435 45 Hansmann M Hackel er B Staudach A Ultrasound Diagnosis in Obstetrics and Gynecology Springer Verlag 1990 B CFM Hansmann ISBN 0 387 15348 9 Springer Verlag New York P 431 H Schaffer IPDS 1998 11th Congress of the International Perinatal Doppler Society Schaffer JOURNAL F R FERTILTAT UND REPRODUKTION July 2 4 1998 R Mai P Kristen A Rempen Farb Dopplersonographisme Normalwerte in der Schwangershaft Z Geburish u Perinat P 221 222 R Mai P Kristen A Rempen Farb Dopplersonographisme Normalwerte in der Schwangershaft Z Schaffer Geburish u Perinat P 221 222 R Mai P Kristen A Rempen Farb Dopplersonographisme Normalwerte in der Schwangers in Geburish u Perinat P 221 222 e e Occipitofrontal Diameter e Transverse Abdominal Diameter e Thoracic diameter e Fetal Aorta PI Fetal Aorta RI
113. ght button to choose an application It is impossible to change application when a patient file with a report is open Exit of the list of applications and presets by clicking the key Preset 17 2 Presets For each application one or several predefined presets are stored in the device together with the presets created by the user s see chapter 17 2 2 The number of factory presets depends on the application When an application is selected see chapter 17 1 the list of available presets is displayed at the middle left of the screen When passing the curser on the list each preset is highlighted successively A preset includes all adjustable parameters and controls in all modes 17 2 1 Load a preset Pass the curser on the list and click Select with the left button on the wanted preset to load the application with the selected preset When the application and preset have been loaded the device returns to the imaging mode and the list of applications and presets disappear The current preset and application are displayed in the upper right of the screen If the imaging mode was live during the selection of application and preset the device returns to a live B image no matter which mode was used before changing the application and the preset Selection of another imaging mode can now be made see chapter 7 on M Mode chapter 8 for CFM Mode chapter 9 for PW Mode chapter 10 for B CFM PW mode chapter 11 for CW Mode If the imaging mod
114. he factory presets 9 18 B Mode controls The following adjustments of the B image stay active in the B PW Mode Gain TGC Depth Please refer to the chapter 6 for further details of the B Mode controls Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 43 sur 173 BECM Noveko 10 B CFM PW Mode The system makes triplex imaging adding an active CFM image and an active PW image to the B image Activation of the CFM image by pressing the CFM knob Key number 5 Please see chapter 8 for details of the CFM controls Activation of the PW image by pressing the PW knob Key number 6 Please see chapter 9 for details of the PW controls Display of the contextual B CFM PW menu When all 3 modes are active the cursor is trapped in the PW gate for adjustment of position and size To unleash the cursor click Select with the left button 10 1 PW mode controls All PW controls are available Please see chapter 9 for details 10 1 1 Invert Contextual menu Inversion of the PRF scale in PW and inversion of the CFM Velocity colors attributed to the two directions of the flow by the key Invert in the contextual PW menu The peaks underneath the baseline will be above and conversely When the Invert function is activated the key is highlighted in red and Invert is displayed on the top of the PW spectrum 10 1 2 Steering Key number 11 The PW gate line and the CFM box can be steered by the rocker switch St
115. he sub menu by pressing the key Exit 6 18 1 B Average Extra B tools contextual sub menu Adjustment of the time average between the B images by the keys B Average and B Average in the Extra B tools contextual sub menu The updated B Average level is displayed on the right of the screen Min average 50 Max average 200 4 steps 6 18 2 Color Extra B tools contextual sub menu Pseudo coloration of the B image by pressing the keys Color and Color in the Extra B tools contextual sub menu 5 color steps are available 6 18 3 TEQ Tissue Equalisation Extra B tools contextual sub menu Activation of the function Tissue Equalisation by the key TEQ in the Extra B tools contextual sub menu When the function is active the key is highlighted in red The Equalizer box appears on the image and can be positioned on the wanted place by Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 34 sur 173 BECM Noveko dragging the trackball To validate the position and unleash the cursor click Select To reactivate the positioning of the Equalizer box click Select inside the box Click on the key TEQ to deactivate this function and remove the Equalizer box 6 18 4 High Resolution Extra B tools contextual sub menu Activation and deactivation of the high resolution function by the key High Res in the Extra B tools contextual sub menu High resolution takes advantage of the use of wide band probes and improves the axia
116. he wanted place immediately after turning on the CFM mode The contour of the CFM box is a white line when the repositioning is activated To adjust the size click Select with the right button The contour of the CFM box is a white dotted line when the adjustment of the size of the box is activated Move the trackball horizontally left right to adjust the width Move the trackball vertically up down to adjust the height Click Select with the right button to change between adjustment of size and position Click Select with the left button to validate the new position and or size and to unleash the cursor The contour of the CFM box is a yellow line when position and size are validated To re activate the adjustment of position or size of the box place the cursor in the box and click Select left or right button Follow the description above Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 38 sur 173 BECM Noveko Repositioning of the box is also possible by clicking the key Position in the contextual CFM menu Click Select with the left button or click the key Position once again to validate the new position and unleash the cursor Adjustment of the size of the box is also possible by clicking the key Size in the contextual CFM menu After adjustment of the size click Select with the left button or click the key Size once again to validate the new size and unleash the cursor 8 3 Frequency Key n
117. ht part of the screen In order to get access to the reports it is necessary to open a patient file and start an examination see chapter 19 It is possible to change the probe when a patient file is open It is also possible to change preset when a patient file is open To change application the patient file must be closed and re opened after changing the application see chapter 17 19 4 1 Examination without report If a patient is only selected without the user pressing start the following message is displayed in the imaging mode Exam without report In this case the measurements etc are not stored in the patient s report If images and sequences are stored with a selected patient they will be attached to the patient file in the Review menu To exit this mode and open a report click Start in the Patient page To exit this mode and quit the patient click Unselect in the left part of the Patient page 19 4 2 Examination in Obstetrics 19 4 2 1 Entering the LMP When starting an examination in the application Obstetrics the device automatically enables the user to enter the last menstrual period in the field LMP The last menstrual period is used for several calculations in the obstetrical protocol Enter the LMP either with the alphanumeric keyboard before starting the examination When the LMP is entered the GA according to this date is displayed on the screen in the imaging modes GA Ref The percentiles are calculated according
118. hted in red Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 42 sur 173 BECM Noveko 9 13 Simplex Duplex Contextual menu Activation of the Simplex mode where only the PW is live by the key Simplex in the contextual PW menu The B image is frozen and the PW Doppler quality is improved The key Duplex appears in the contextual PW menu and enables to deactivate the Simplex mode and return to Duplex mode where both the B and the PW imaging modes are active 9 14 Noise Reject Contextual menu Increase and decrease of the noise filter by the keys Noise Reject and Noise reject in the contextual PW menu The noise reject indicator is displayed at the right of the screen Min noise reject 1 Max noise reject 10 9 15 Wall Filter Contextual menu Increase and decrease of the Wall filter filtering of low frequencies by the keys Wall Filter and Wall Filter in the contextual PW menu The velocities nearest to the baseline are filtered The filter indicator is updated on the right of the PW frame Min filter 1 Max filter 4 9 16 Time scale Contextual menu Increase and decrease of the PW spectrum s time scale by the keys Time Scale and Time Scale in the contextual PW menu The scale in seconds is updated The time scale goes from 1 to 10 seconds 9 17 Color Contextual menu Coloration of the PW spectrum by the keys Color and Color in the contextual PW menu The coloration is active on t
119. icate the positioning of the focus es on the depth scale NB The device automatically deletes the focuses when these are exceeding the depth Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 31 sur 173 BECM Noveko 6 5 1 Focus Gap contextual menu Possibility to enlarge the space between each focus point by pressing the key Focus Gap in the contextual B menu second level When the Gap function is active the button is highlighted in red This function enables to widen the focalized part of the image To return to the focus points without extra gap press the button Focus Gap once again 6 6 Zoom Key number 8 Choice of zoom mode in the Setting menu see paragraph 3 4 Full screen or Picture in Picture Activation and deactivation of the chosen mode by clicking the Zoom knob 6 6 1 Full screen mode The activation makes a pointer appear on the image If the pointer is not at the wanted place it can be repositioned by moving it with the trackball The new position is validated by pressing Select or by turning the zoom knob In full screen zoom mode the image is circled in yellow Increase of the zoom scale positive zoom by turning the Zoom knob clockwise up to 35 positive zoom levels depending on probe and depth Decrease of the zoom scale negative zoom by turning the Zoom knob anticlockwise up to 35 negative zoom levels depending on probe and depth The updated zoom scale is displayed at the r
120. ight of the screen The following modes can be activated on the full screen zoomed image M CFM PW CFM PW CW In 4D mode the volume can be zoomed and de zoomed in live and freeze mode see chapter 12 2 8 6 6 2 Picture in Picture mode The activation makes a blue square appear on the image and the zoomed part is showed on the right of the screen If the zoomed zone is not at the wanted place it can be repositioned by moving it with the trackball and the new position is validated by pressing Select Increase and decrease of the zoom scale by turning the Zoom knob up to 3 zoom levels The updated zoom scale is displayed at the right of the screen In 4D mode the full screen zoom is always available no matter which zoom mode is selected see chapter 12 2 8 NB In both zoom modes the following functions are still available Focus Gain TGC Depth only in PIP mode Frequency Freeze If you want to use M CFM PW or CW imaging modes on a zoomed image the zooming should be made in B before activating the other modes The zoom function is available on live images on Cineloop frozen images and sequences see chapter 13 and on stored loaded images and sequences see chapter 14 Deactivation of the Zoom mode by pressing the Zoom knob 6 7 Dynamic Contextual menu Increase and decrease of the dynamic scale by the keys Dynamic and Dynamic in the contextual B menu The updated Dynamic scale is displayed on the right of the scre
121. image itself 15 1 1 Distance Contextual menu When turning on the measure mode the curser appears automatically in the middle of the image ready for measuring the first distance Place the marker at the wanted place with the trackball Validation of the position by the left Select button Place the second marker with the trackball at the wanted place Click on the right Select button to pass from one marker to another in order to adjust the distance The active marker is white Click the left Select button to validate To reposition the whole distance click on one of the small spots and drag the distance with the trackball Validation of the new position by the left Select button The result of the distance measurement is displayed at the bottom left corner of the screen 4 distance measurements are available on one image Click on the key Distance in the contextual Measure menu with the Select button to activate a new distance When the box Distances in Sequence in ticked in the Settings menu see chapter 5 4 4 distances will automatically appear successively The active distance measure is highlighted in a different color If the box Distances in Sequence is not ticked only the first distance is automatic and further distance measurements can be selected in the contextual measurement menu 15 1 2 Ellipse Contextual menu Click on the key Ellipse in the contextual Measure menu with the Select button to activate an ellipse measureme
122. is Distance Stenosis Surface Right PT Artery Right Posterior Tibial Artery Distance Surface Stenosis Distance Stenosis Surface Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 166 sur 173 BECM Noveko APPLICATION VASCULAR Mode PW Abbreviation Organ Measure tool Version 3 du 16 07 2012 ICA CCA ICA CCA Ratio Left Com Carotid Artery Left Common Carotid Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Right Com Carotid Artery Right Common Carotid Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Left Ext Carotid Artery Left External Carotid Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Right Ext Carotid Artery Right External Carotid Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Left Int Carotid Artery Left Internal Carotid Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Accelera
123. itty FG Le LL Ses mem Se 440 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 128 sur 173 BECM Noveko FL Hadlock FG FL Hansmann Identical Ae 39mm S S S Po ET 22 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 129 sur 173 BECM Noveko FL Osaka Identical 2SD FL Tokyo FG E RER H O H S ER RE E399 EE E99 EE Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 130 sur 173 BECM Noveko FTA Osaka Identical a E RE a a a GS Hansmann EE 6 2 6 5 7 3 8 2 9 0 GS Tokyo FG CECR 9 7 CL 9 ILLUM H E399 1 59 E88 E 9 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 131 sur 173 BECM Noveko GS Rempen FG Cell HA Chitty FG 3 cm 50 cm 97 cm SEBES LL 39 8 7 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 132 sur 173 BECM Noveko HC CFEF FG 50 mm 68 1 82 1 97 mm 80 7 95 2 109 5 123 6 137 4 151 1 164 5 177 6 190 5 203 1 198 4 215 4 209 9 227 4 221 1 239 23 250 3 242 5 261 2 252 6 271 8 262 4 282 271 7 291 8 280 6 301 1 289 1 310 297 2 318 5 304 8 326 6 311 9 334 1 318 5 341 2 324 6 347 8 330 3 353 8 335 3 359 3 339 9 364 3 343 9 368 7 347 3 372 6 350 1 375 8 109 6 123 1
124. ity with the components of the probes has been proved Cidex Cidex plus Cidex OPA It is strongly recommended to use one of these solutions in order to avoid any deterioration during the cleaning and disinfection procedure Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 81 sur 173 BECM Noveko N WARNING The use of any other disinfecting solution than the ones indicated above is dangerous as it may damage the probe components Check the list of specified agents carefully In order to ensure proper cleaning and disinfection please follow the following procedure After every patient examination wipe the ultrasound transmission gel off the probe Unplug the probe connector from the system Wipe the probe and cable with a clean soft cloth that has been damped in a solution of mild soap and water Follow carefully the low level disinfection instructions indicated by the disinfectant manufacturer Remove any cleaning solution residue with a soft clean cloth damped in sterile water Air dry or dry with a soft clean and dry cloth Ov urge Wo 22 2 2 Endo cavity probes Endo cavity probes have a medium infection risk This risk level corresponds to the use of so called semi critical medical devices which means devices which are in contact with mucus membranes or superficially injured skin The needed treatment for this type of medical device is a medium level disinfection Low level disinfecti
125. justment in PW of the angle and or the steering by ticking the circle Options None Angle or Angle and Steering See chapter 9 7 PW angle on start If the box is ticked the automatic angle correction will be active when turning on the PW mode See chapter 9 7 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 27 sur 173 BECM Noveko Background color Choice of background color Black Dark grey Grey Light grey US image Selection of reduced image size by ticking the box Auto Focus If the box is ticked the frequency and focuses will be automatically adapted according to the change of depth If several focuses are used on the image the automatic focus will be the upper one the other focuses will be placed deeper PW starts CW When ticking the box pressing PW will always activate CW when using the phased array probe in cardiology application Activation of PW in the contextual B menu When the box is not ticked activation of CW in the contextual B menu See chapter 11 Report printing on thermic printer Selection between USB and video out connection for the thermal printer See chapter 21 1 for a summarizing table of out puts See chapter 20 about reports Video out connected thermal printer Printing by pushing the button on the printer Display the patient report in Print Preview and print each displayed page one after the other USB connected thermal printer Printing by pressing Print on Imagyn
126. l calculations are displayed in a list in the window on the left of the screen When passing the curser on the list the protocol calculations are highlighted successively To load a protocol calculation click Select The measurement tool is ready on the image The curser is trapped by the first marker of the measurement Place the first marker at the wanted place with the trackball Validation of the position by the Select button left or right Place the second marker with the trackball at the wanted place Click on the right Select button to pass from one marker to another in order to adjust the measurement The active marker is white Click the left Select button to validate To reposition the whole measurement click on one of the small spots and drag the measurement with the trackball Validation of the new position by the left Select button The result of the measure is displayed in the middle of the window If the measure is interpreted by a table or is used for a calculation the result is displayed in the bottom of the window 18 3 1 Measurement of Intima Media Thickness IMT The measurement of Intima Media Thickness IMT is available in B Mode in the following applications General and Vascular Load the wanted application see chapter 17 Press Protocol The measure should be made on a longitudinal cut of a vessel Select Intima Media in the Protocol in the left of the screen The curser is trapped by a marker Place the marker on the
127. l resolution of the image When this function is activated the key is circled in red 6 19 Display size Contextual menu Access to the sub menu of Display Size tools by the key Display Size in the contextual B menu Exit of the sub menu by pressing the key Exit 6 19 1 Orientation of image Display Size contextual sub menu Turn the image up or down by the key U D in the Display Size contextual sub menu Turn the image left or right by the key L R in the Display Size contextual sub menu Rotation of the image by 90 by the key Rotation 0 in the Display Size contextual sub menu 90 180 270 Reset the orientation by the key Reset Rotation in the Display Size contextual sub menu 6 19 2 FOV Field of View Display Size contextual sub menu Activation and adjustment of the field of view of the image by the keys FOV and FOV in the Display Size contextual sub menu The frame rate is updated according to the adjustment of the Field of view This function is not available on the phased array probe Warning The reduction of the field of view FOV might lead to an important increase of the TI index of acoustic power displayed at the upper right of the screen The use of a reduced field of view enables to increase the frame rate but this function should be used with precaution according to the warnings concerning the acoustic power described in the chapter 2 1 in this manual 6 19 3 Trapezoidal image Display Size contextual sub menu
128. l to represent the temperature rise in all conditions and for all type of tissues A TI index of 2 represents a higher temperature rise than a TI index of 1 but cannot be considered as a temperature rise of 2 C The TI index is intended to advise the user of a possible temperature rise in a specific area 2 1 4 Accuracy of MI and TI parameters display The mechanical and thermal indexes are displayed permanently and explicitly on the screen in the upper right corner See chapter 5 2 During the use of the device the operator must survey the effect of the controls which are influencing the acoustic power and if necessary write down the values of the indexes As indicated above the operator must permanently try to maintain the indexes at their lowest possible level and to reduce the exposure length The preciseness of the display of the mechanical and thermal indexes MI and TI is at O 1 2 2 Safety symbols Please note the meaning of the following safety symbols Symbol Signification Type BF patient applied part B body F floating e applied part 4 The probe complies with the class BF Medical Electric equipment compliant with the standard L al IEC 60601 1 Warning Read the user manual before using the device bearing this symbol Warning do not sit on the equipment Warning do not push the equipment if the castor wheels are locked On off switch General power switch O I 9 Versio
129. layed below the list Press Select with the left button on the name in the list to load the image or the sequence immediately An image or sequence can also be loaded after selection with the right Select button by pressing the key Load in the contextual Review menu The following message is displayed on the screen during loading Image loading or Sequence loading Don t press any key before this message disappears The loaded image or sequence appears on the screen with a white contour and the name of the sequence or the image in the upper left corner Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 53 sur 173 BECM Noveko It is now possible to make post processing See chapter 16 or measures See chapter 15 on the loaded image or sequence After modifications the image or sequence can be stored in its new version See chapter 14 1 and 14 2 for the storing procedure 14 3 4 Rename Contextual menu To select an image or a sequence to rename pass the cursor with the trackball on the list in the second column The names will now be highlighted successively in blue A thumbnail of the selected image is displayed below the list Press Select with the right button The selected image or sequence can now be renamed by pressing the key Rename in the contextual review menu The text can be changed by entering the new text with the alphanumeric keyboard To validate the new name press the key Enter on the
130. layed in the upper left window ready for modifying starting an examination or consulting an existing examination report Click Unselect in the box below the list of patients to deselect the patient file Click on the key Patient to exit the patient menu and return to imaging mode Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 73 sur 173 BECM Noveko 19 4 Start an examination Before choosing the patient choose the application and preset in which the examination should be operated see chapter 17 The examination including available protocols see chapter 18 is determined by the selected application Activation of the patient menu by clicking the key Patient Select an existing patient by clicking Select in the patient list or create a new patient see chapter 19 1 According to the applications one or several protocols are available in the middle of the window If the user has created any individual user protocols these are also available for selection see chapter 18 2 Select the wanted protocol in the menu by clicking Select Depending on the applications different information which is necessary for the examination can be entered After entering this information click Start The device returns to the imaging mode To start the examination click Start in the middle left part of the window When an examination with a selected patient is started the name of the patient is displayed in the upper rig
131. lick in the middle of the box in the Patient menu in front of Number of fetuses Nb fetuses to get access to the list If Twin 2 or Triplet 3 is selected the boxes T1 and T2 on the bottom of the screen indicate twins and Tr1 Tr2 and Tr3 triplets The boxes are displayed when the image is frozen The boxes can be activated by clicking Select on the box in order to allocate Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 74 sur 173 BECM Noveko an image a measurement or a calculation to s specific fetus The selected indication for instance T2 for Twin 2 is displayed just underneath the image If the image is printed this fetus indication is also printed All measures and calculations are made separately for each fetus In the report see chapter 20 the results are listed separately for each fetus 19 4 3 Examination in Cardiology When starting an examination in the application Cardiology the device automatically enables the user to enter the height in m and the weight in kg of the patient This information is used for the calculation of the Body Surface Area and Cardiac output see chapter 18 6 1 19 5 Adding elements to the report When a patient file is open the measures and calculations available in the chosen protocol are automatically added to the report when the measure is validated A number in parenthesis indicates how many times this measure was made Images can be stored in the repor
132. lick on the key Patient to exit the patient menu and return to imaging mode 19 2 Modify a patient Activation of the patient menu by clicking the key Patient Select the patient to modify in the list of existing patients In the upper right window click Modify with the left Select button The patient information fields get accessible After modifying the patient data click Save to validate The modified data of the patient are stored If you do not want to store the changes click Cancel with the left Select button instead of Modify The modifications will not be stored and the patient data stay the same Click Unselect in the box below the list of patients to deselect the patient file Click on the key Patient to exit the patient menu and return to imaging mode 19 3 Search a patient Activation of the patient menu by clicking the key Patient Click Select in the empty white field situated just below the list of existing patients and enter the text for searching Choose if you want to search by Patient Name or ID by ticking the corresponding box Click Search to start searching for the entered text The result of the research is highlighted If several patients correspond to the research they are displayed in the top of the patient list Select the wanted patient or make a more precise research by following the procedure described above If only one patient corresponds to the research the patient is highlighted and the patient data are disp
133. lishers Inc 1991 P 312 Norio Shinozuka Haruo Masuda Hidenori Kagawa Yuji Taketani Standard Values of Ultrasonographic Fetal Biometry Tokyo Jpn Med Ultrasonics Vol 23 NO 12 1996 P 877 888 Chitty L S Altman D G Charts of Fetal Size 2 Head Measurements B CFM Chitty 0 0 British Journal of Obstetrics amp Gynaecology jan 1994 vol 101 P 35 43 Biometry 2000 Fetal growth charts by the Coll ge Fran ais d Echographie Foetale CFEF the French College of Fetal Ultrasonography and INSERM U 155 B CFM CFEF Gynecol Obstet Fertil 2000 Jun 28 6 435 45 Hadlock FP Deter RL Harrist RB Park SK Estimating fetal age Computer assisted analysis of multiple fetal growth parameters B CFM Hadlock Radiology 1984 152 497 502 Hansmann M Hackel er B Staudach A Ultrasound Diagnosis in Obstetrics and Gynecology Springer Verlag 1990 Hansmann ISBN 0 387 15348 9 Springer Verlag New York P 440 441 Mineo Aoki Motohiro Yamada Evaluation of fetal growth Osaka Obstetrics and gynecological treatment Vol 47 NO 5 1983 11 Norio Shinozuka Haruo Masuda Hideroni Kagawa Yuji Taketani Standard Values of Ultrasonographic Fetal Biometry PD Tokyo Jpn Med Ultrasonics Vol 23 No 12 1996 P 877 888 Yarkoni S Schmidt W Jeanty P et al Clavicular measurement A new biometric parameter for fetal evaluation Clavicle Length Clavicle Yarkoni J Ultrasound Med 4 467 470 1985 Hadlock FP Shash YP Kanon DJ Lindsey JV Fetal Crown rump
134. m Maximum Index Value 1 08 0 28 a Pra MPa 2 24 P mW 13 7 a MinPalzslta al s Z cm Zbp cm ccc ul z au max loi a cm 5 degl2p cm fawf MHz 4 27 4 275 a Dim Ant 16 a Y 12 a ty Hs 0 31 prr Hz 32 Other information p au max de loi 4 68 deq au max lpi cm Ina au max MI W cm 317 a This probe is not appropriate for trans cranial or cephalic application on a new born baby Probe model 4DC540V Mode CFM TIS TIB Index label MI eg Non scan Non TIC Aaprt lt 1cm Aaprt 1cm scan Maximum Index Value 1 09 0 53 a Pra MPa 2 25 P mW 31 a Min Polsha as Ze cm Zbp cm e zau max loi T cm 5 deq 2p cm Lat MHz 3 51 3 51 a Dim Asprt x 16 a Y 12 a ty Hs 0 73 prr Hz 165 Other information p au max de lo 3 28 deq au max li cm loa a au max MI W cm 135 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 108 sur 173 BECM Noveko Probe model 4DC540V Mode PW TIS TIB Index label MI Non scan Non TIC Aaprt lt 1cm A n 1cm scan Maximum Index Value 0 53 1 91 1 21 a Pra MPa 0 94 P mW 33 70 a MinPalzslta al s 20 Zs cm 2 3 Zbp cm 2 3 S i s z au max loi a cm 5 degl2p cm fawf MHz 3 19 3 19 3 19 a Dim Aaprt X 16 16 a Y 12 12 a ty Hs 1 79 prr Hz 5120 Other information p au max de loi 1 63 deq au max lpi cm La a 8u max MI W cm 29
135. mage on the probe connector and to the possibility of much higher acoustic output than required This can also lead to patient burn due to overheating of the probe The Imagyne device is designed to be used exclusively with probes supplied by ECM together with the device gt Warning Never try to connect a probe to the Imagyne device which is not supplied by ECM and described to fit the Imagyne equipment This can lead to irreversible damage on the Imagyne probe connector and to the possibility of much higher acoustic output than required This can also lead to patient burn due to overheating of the probe gt Warning Check the cleanliness of the probes before starting an examination Also check the probe in order to detect any shock crack or damage on the casing and the acoustic lens Never use a damaged probe for an examination gt Warning For safety and maintenance reasons never disconnect a probe from the device without freezing the system first 2 8 Probe information 2 8 1 Probe types and corresponding applications The probes provided with the Imagyne device are the following C360V Convex probe central frequency 3 5 MHz This external probe is used for the following applications General abdominal gynecology obstetrics vascular C360A Convex probe central frequency 3 5 MHz This external probe is used for the following applications General abdominal gynecology obstetrics vascular C360R Convex probe
136. magyne equipment starts in B mode with the probe connected on the first probe connector If no probe is connected to the first right hand side probe connector the system will display a message No probe or unknown probe In this case connect a probe to the first right hand side connector and click on Retry To stop the equipment click on the cross situated in the upper right corner of the screen A shutdown procedure will be performed until the complete stop of the equipment A forced stopping of the device that should only be used in case of malfunctioning of the device can be made by pressing for a short while the On off switch with the following symbol D When you are no longer using the device and have shut it down it is recommended to switch off also the general power switch situated on the lower rear part of the device in order to turn the electricity supply of the device completely off Warning After turning off the equipment it may be necessary to wait for about one minute before restarting the equipment to avoid having the electronical device not ready to start and the display of an error message In this case shut down the equipment and wait for a minute before restarting it Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 21 sur 173 BECM Noveko International Inc 5 Presentation of the device 5 1 Keyboard illustration T
137. max lpi cm 8 deq zb cm fawf MHz 3 11 3 11 3 11 a Dim Aaprt X 21 21 a Y 11 11 a td us 1 77 prr Hz 5120 Other information pr at max Ipi 1 89 deq at max Ipi cm Ipa Bl at max MI W cm 20 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 95 sur 173 BECM Noveko Probe model C360R Mode B TIS TIB Index label MI Non scan TIC Scan Non scan Aaprt lt 1 cm Aaprt gt 1 cm Maximum Index Value 0 95 0 22 a pra MPa 1 80 P mW 13 a Min PBI zs Ita Pl zs zs cm g zbp cm Associated acoustic parameters zi m z at max Ipi cm 8 deq zb cm fawf MHz 3 54 3 54 a Dim Aaprt X 21 a Y 11 a td us 0 38 prr Hz 32 Other information pr at max Ipi 4 78 deq at max Ipi cm Ipa Bl at max MI W cm 106 a This probe is not appropriate for trans cranial or cephalic application on a newborn baby Probe model C360R Mode CFM TIS TIB Index label MI Non scan TIC Scan Non scan Aaprt lt 1 cm Aaprt 1 cm Maximum Index Value 1 15 0 40 a pra MPa 2 16 P mW 24 a Min PBP zs Ita 2 zs zs cm zbp cm Associated acoustic parameters m z at max lpi cm 8 deq zb cm fawf MHz 3 54 3 41 3 54 a Dim Aaprt X 21 a Y 11 a td us 0 38 prr Hz 8 Other information pr at max Ipi 5 73 deq at max Ipi cm Ipa Bl at max MI W
138. ment can now be deleted 15 1 8 Print Print Printing of the currently displayed image with measures if any by pressing the key Print in the contextual Measure menu If several printers are available and if the box Select Printer at Print is ticked see chapter 5 4 the device proposes a selection of printers Otherwise printing is made on the default printer 15 1 9 Delete Contextual menu Click on the key Delete in the contextual measure menu to delete the last measure item made measure arrow annotation or the selected measure item See chapter 15 1 7 15 1 10 Delete all Contextual menu Click on the key Delete All in the contextual measure menu to delete all measure items made measure arrow annotation Exit of the Measure mode and return to Freeze mode by pressing the key Measure Exit of the Measure mode and return to live imaging by pressing the key Freeze 15 2 Measures in M Mode 15 2 1 Rate Contextual menu When turning on the measure mode in M Mode the curser appears automatically in the middle of the M specter ready for measuring the rate Click Select left or right button to make the distance markers appear on the M specter Place the curser on the wanted place of the first distance marker click Select and place the second distance marker with the trackball Click on the right Select button to pass from one marker to another in order to adjust the positions The active marker is white Click the left Select but
139. ments composed of three parts used for a volume calculation for instance Thyroid Start by making the first two distance measurements Width Height as described above Defreeze Freeze again when the wanted cut is found Load the last measurement Depth by clicking left Select and make the third distance measurement The volume calculation is made automatically by the device See the list of the content of the small parts protocol in chapter 29 18 11 Protocols in Urology Same procedure as for the above listed protocols For measurements composed of three parts used for a volume calculation for instance Bladder Start by making the first two distance measurements Width Height as described above Defreeze Freeze again when the wanted cut is found Load the last measurement Depth by clicking left Select and make the third distance measurement The volume calculation is made automatically by the device See the list of the content of the urology protocol in chapter 29 18 12 Protocols in Vascular In the Preset menu select the application Vascular Select the imaging mode B M CFM PW Press Protocols The available protocol calculations are displayed in a list in the window on the left of the screen All protocol calculations marked with indicate a group See chapter 18 1 1 about how to use the grouped protocols Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 71 sur 173 BECM Noveko To return
140. menu 46 12 2 11 Contrast Contextual menu 46 12 2 12 Color contextual menu 48 12 2 13 Dynamic contextual menu 46 12 2 14 Gamma contextual menu 46 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 4 sur 173 BECM Noveko 12 2 15 Smoothening contextual menu 46 12 3 AD EE 48 12 3 1 Rotate Key number 8 49 12 3 2 Volume contextual menu 49 12 3 3 Multicut contextual menu 49 12 3 4 Cube contextual menu 49 12 3 5 Slanting cut contextual menu 49 12 3 6 Explorer 3D Contextual menu 49 12 3 7 Print contextual ME 49 12 3 8 Smoothening contextual menu 49 12 3 9 Opacity Key number E 50 12 3 10 Luminosity Key number 6 eene enne nenne enne nennen nenne EEA tenens en 50 12 3 11 Reject Contextual men ciet CERE EER ERN OR Te bU VERTES VERTUS EUR Ub vex ved PARE PEG 50 12 3 12 Contrast Context al ET E 50 12 3 13 Color contextual menu 50 12 3 14 Dynamic contextual menu 50 12 3 15 Gamma contextual menu 50 13 FREEZE MODE CINELQOOD ioi see et eto deed 51 14 STORE IMAGES AND CLIPS REVIEW eene ee eere enero eo oeeo eneon onen oeeo 52 14 1 STORE IMAGE KEY NUMBER 22 52 14 2 STORE CUP KEY NUMBER 21 erret tete e e RE ER Er e elec EC e FW eee te Pe Pre fer one 52 14 3 REVIEW KEY NUMBER 20 sccssccessseessecssssessecesssecssecssceecsaecsssessascsssseseascssssessascsuaseceascsssessaseeeasecaseseasesss 53 14 3 1 MUITIVIGW E
141. must comply themselves with the standard EN 60601 1 1 Otherwise the global configuration can no longer be considered patient safe gt Warning A risk of electrical shock may exist if the system is not properly grounded The system must be connected to the electrical power network by a three hole outlet with a connection to ground gt Warning Removing the power cord from the equipment may be used a s a safety action Always place the equipement in a situation where the operator can easily access to the power cord to remove it quickly and safely if needed gt Warning Always inspect the probe head housing cable and power cord before use see section 2 8 probe information Any crack or damage to the probe head can lead to electrical shock Never use a probe that is damaged that has been dropped or has been suffering a severe shock until it has been inspected by an ECM customer service engineer gt Warning Do not soak the transducer connector in any liquid Soaking it can destroy its electrical safety features gt Warning Always disconnect the system prior to cleaning gt Warning Only the ECG kit cable and suction cups provided by ECM can be used on the ECG output on the device ECM references for the ECG kit ECG cable 31 1994 ECG suction cups 31 1995 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 13 sur 173 BECM Noveko 2 5 Patient environment The Imagyn
142. n Click Unselect in the box below the list of patients to deselect the patient file Click on the key Patient to exit the patient menu and return to imaging mode 19 1 Create a new patient Activation of the patient menu by clicking the key Patient In the upper right window click New with the left Select button The patient information fields get accessible and the curser is ready in the field Name Fill in the new patient file with the following information by entering the text with the alphanumeric keyboard Name ID First name and Address Only name and or ID are necessary for listing and searching one patient amongst others Other patient data can be filled in if wanted Enter the sex of the patient by choosing between male female in the menu proposed by the device Enter the birthday of the patient composed by the date the month and the year with the alphanumeric keyboard The device automatically passes from the date to the month and to the year The device automatically calculates the patient s age It is also possible to enter the patient s age in years Enter the comments in the field provided for this and the referent doctor if any Validation by clicking Save The patient s data are stored and the patient is added to the list of existing patients displayed in the upper left part of the screen Click Cancel in order not to store the patient file Click Unselect in the box below the list of patients to deselect the patient file C
143. n 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 11 sur 173 BECM Noveko waste Collect separately from other waste see European Commission Directive for electronic C CE Mark 2 3 Environmental conditions of use The device shall be operated in a clean atmosphere without dust and smoke The device is designed and tested to be operated within this range of temperature 20 C to 60 C during transportation and storing 10 C to 40 C during operation The device is designed to be operated with a relative humidity range from 10 to 95 including condensation The device is designed for the following atmospheric pressures 700hPa to 1060 hPa while in operation 500hPa to 1060 hPa during transportation and storing Warning Never use the device if these environmental conditions are not respected Stop operation of the device if one of these conditions is no more respected The device can be used in any room or place respecting these environmental conditions In order to ensure proper cooling of the device do not block the ventilation fans or obstruct the air exhaust at the rear of the device Do not place the equipment against a wall or in a confined area this will result in a bad cooling of the equipment A minimal distance between walls and the device must be respected typically 30 cm Warning Never block the fans or obstruct air exhaust this will lead to overheating o
144. n a table the author of the table is displayed next to the measure with the corresponding percentile The graphical representation of the percentile is displayed in the top of the screen when clicking on the measure If several authors are available for the same table in the selected protocol the author can be changed by clicking on the name of the active author The list of available authors is displayed Select the wanted author Graphs percentiles etc are recalculated according to the used author The LMP can also be changed in the report by clicking on the date The following information is also displayed in the report GA Conception date Due date Click in the left bottom corner on the window Text to change to the display as a text To return to the list visualization click on the same window now named List 20 1 2 Text display of Report All information is displayed as a text with the layout that will be used for printing Images and graphical representations are showed at the end of the text report 20 1 2 1 Text display of a report in Obstetrics When a measure is used in a table the author of the table is displayed next to the measure with the corresponding percentile The graphical representation of the percentile is displayed at the end of the report The following information is also displayed in the report GA Conception date Due date Click in the left bottom corner on the window List to change to the display as a list
145. n to an inferior level in the contextual menu press the key Previous Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 26 sur 173 BECM Noveko 5 4 Settings Key number 34 Access to the menu of general settings of the device by pressing the key Setting Place the trackball on the wanted function press Select with the left Select button to validate Hospital Name Possibility to enter the hospital or clinic name with the alphanumeric keyboard Maximum 20 characters User Name Possibility to enter the user name with the alphanumeric keyboard Maximum 20 characters System date Adjustment of date Date format Choice of date display DD MM YY YYYY MM DD MM DD YYYY The selected date format is used for all other dates Patient birthday LMP date etc System time Adjustment of time Time format Choice of time display 12h AM PM or 24H Language Choice of language for the interface menus at the screen English French Spanish etc Body marks Possibility to show the body marks The activation by ticking the box makes a body mark appear on the image Click on the body mark to see the whole list according to the active application and preset Click Select on the wanted body mark The whole list disappears automatically Click on the yellow probe indicator on the body mark to reposition the probe indicator Click Select Right to turn the probe indicator The round spot corresponds to the orientation marker
146. nn hn enhn en en enne enhn eere eere nnn 80 22 CLEANING AND DISINFECTION INSTRUCTIONS eere eese eee eene esso neta aetas sena ens ense ta sno 81 22 1 CLEANING AND DISINFECTION OF THE DEVICE sse ee ee e eee 81 22 2 CLEANING AND DISINFECTION OF PROBES ee ee ee 81 22 2 1 External probes eire rr i en it sites et Pi here ton es ee E t ves SI 22 2 2 Endo cavity DroD6S secuta E REY REREN IEEE FEET IR TEE E VERS UE EYE FEE REESE RR E RENE GS SERE ten 62 22 3 SUBMERGING LIMITS sense se senenn cesse seeenn en escenenennnes es cc nennnn es eececennnnnes esse nenennescececenenneseeseeenennsneee 83 23 LABELING OF THE DEVICE as erroe eo ioo rone oo ee ao ora an epa eese are naar oE sa puo ona tea Pon ee ions ERE tue Uo o ER eda tac an 86 24 ANNEX 1 MEASURE ACCURACY cccccsscsssssssssscssscssccssccsccssccesccescsssosescssssesssensconscenecsnscsnccssceesenesees 87 25 ANNEX Il ELECTROMAGNETICAL COMPATIBILITY eene esee eene en ntn atta aetas tn ano 88 26 ANNEX Ill ACOUSTIC POWER sccssscsssssssessssscsssscscesccesscescessteecesscsssccecsencsencsensecnsesssesssesseesseessens 92 27 ANNEX IV TABLES REFERENCES AND CALCULATIONS eese essen essen ennenen 110 27 1 LIST AND BIBLIOGRAPHIC REFERENCES OF OBSTETRICAL TABLES see eee 110 27 2 DETAILED OBSTETRICAL TABLES ccce eene eh nennen nenne ener ene n ene ene e nene nene nene eene nene nene nene nene eene eene 114 27 3
147. nnominate Artery Innominate Artery Heart Rate Time Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 172 sur 173 Version 3 du 16 07 2012 BECM Left Humeral Artery Right Humeral Artery Left Brachial Artery Right Brachial Artery Left Ulnar Artery Right Ulnar Artery Left Radial Artery Right Radial Artery Left Ext lliac Artery Right Ext lliac Artery Left Com Femoral Artery Right Com Femoral Artery Left Profonda Artery Right Profonda Artery Left Tibioperoneal T Right Tibioperoneal T Left Peroneal Artery Right Peroneal Artery Left DP Artery Right DP Artery Left SFA Artery Right SFA Artery Left AT Artery Right AT Artery Left PT Artery Right PT Artery Left Humeral Artery Right Humeral Artery Left Brachial Artery Right Brachial Artery Left Ulnar Artery Right Ulnar Artery Left Radial Artery Right Radial Artery Left Exterior Iliac Artery Right Exterior Iliac Artery Left Common Femoral Artery Right Common Femoral Artery Left Profonda Artery Right Profonda Artery Left Tibioperoneal Trunk Right Tibioperoneal Trunk Left Peroneal Artery Right Peroneal Artery Left Dorsalis Pedis Artery Right Dorsalis Pedis Artery Left Superficial Femoral Artery Right Superficial Femoral Artery Left Anterior Tibial Artery Right Anterior Tibial Artery Left Posterior Tibial Artery Right Posterior Tibial Artery Heart Rate Time Heart Ra
148. nt Circumference and Surface The Ellipse measurement is composed of three markers and several small spots The curser is trapped by the first marker Place the first marker at the wanted place with the trackball Validation of the position by the Select button left or right Draw the size of the ellipse with the trackball Click on the right Select button to pass from one marker to another in order to adjust the form and the size of the ellipse The active marker is white Click the left Select button to validate To reposition the whole ellipse click on one of the small spots and drag the ellipse with the trackball Validation of the new position by the left Select button The result of the ellipse measurement Circumference and Surface is displayed at the bottom left of the screen 2 ellipse measurements are available on one image Click on the key Ellipse in the contextual Measure menu with the Select button to activate a new ellipse The active ellipse measurement is highlighted in a different color 15 1 3 Trace Contextual menu Click on the key Trace in the contextual Measure menu with the Select button to activate a trace measurement Circumference and Surface Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 55 sur 173 BECM Noveko The trace measurement is composed of one marker and several small spots The curser is trapped by the marker Place the marker at the wanted place with the trackb
149. ocessing See chapter 6 15 on how to use this function Extra B Tools B Average Color TEQ see chapter 6 18 Display Size Orientation See chapter 6 19 16 2 M Mode In M mode the following controls are available for post processing 16 2 1 B controls Gain See chapter 6 3 TGC See chapter 6 4 Dynamic See chapter 6 7 Gamma See chapter 6 17 Ima Level See chapter 6 16 Extra BM Tools B Average Color BM See chapter 6 18 and 7 3 16 3 CFM Mode In CFM mode the following controls are available for post processing 16 3 1 CFM controls Gain See chapter 8 4 Invert See chapter 8 1 1 1 This control is only available in CFM Velocity mode Reject See chapter 8 7 Echo Filter See chapter 8 8 CFM Average See chapter 8 11 Wall Filter See chapter 8 9 16 3 2 B controls Gain See chapter 6 3 TGC See chapter 6 4 Dynamic See chapter 6 7 Gamma See chapter 6 17 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 62 sur 173 BECM Noveko Ima Level See chapter 6 16 Extra B tools B Average Color See chapter 6 18 Display Orientation See chapter 6 19 16 4 PW Mode In PW mode the following controls are available for post processing 16 4 1 PW controls Gain See chapter 9 3 Angle See chapter 9 7 Invert See chapter 9 9 Baseline See chapter 9 8 Noise Reject See chapter 9 14 Wall Filter See chapter 9 15 Color See chapter 9 17 16 4 2B controls Gain See chapter 6
150. odel C360A Mode B TIS TIB Index label MI Non scan TIC Scan Non scan Aaprt lt 1 cm Aaprt gt 1 cm Maximum Index Value 0 95 0 22 a pra MPa 1 80 P mW 13 a Min PBI zs Ita Pl zs zs cm g zbp cm Associated acoustic parameters zi m z at max Ipi cm 8 deq zb cm fawf MHz 3 54 3 54 a Dim Aaprt X 21 a Y 11 a td us 0 38 prr Hz 32 Other information pr at max Ipi 4 78 deq at max Ipi cm Ipa Bl at max MI W cm 106 a This probe is not appropriate for trans cranial or cephalic application on a newborn baby Probe model C360A Mode CFM TIS TIB Index label MI Non scan TIC Scan Non scan Aaprt lt 1 cm Aaprt 1 cm Maximum Index Value 1 15 0 40 a pra MPa 2 16 P mW 24 a Min PBP zs Ita 2 zs zs cm zbp cm Associated acoustic parameters m z at max lpi cm 8 deq zb cm fawf MHz 3 54 3 41 3 54 a Dim Aaprt X 21 a Y 11 a td us 0 38 prr Hz 8 Other information pr at max Ipi 5 73 deq at max Ipi cm Ipa Bl at max MI W cm 154 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 94 sur 173 BECM Noveko Probe model C360A Mode PW TIS TIB Index label MI Non scan TIC Scan Non scan Aaprt lt 1 cm Aaprt gt 1 cm Maximum Index Value 0 45 0 61 1 14 a pra MPa 0 80 P mW 73 a Min PB zs Ita 2 zs 41 zs cm 2 6 zbp cm 2 6 Associated acoustic zb cm 6 5 6 5 parameters z at
151. omponents but not for their efficiency in producing the required level of disinfection For information about the efficiency of each solution please consult the respective disinfectant manufacturer N WARNING Do not soak the probe in a solution any longer than the disinfection agent manufacturer s recommendation Follow the disinfection agent manufacturer s recommendations for disinfection N WARNING Do not rub the probe with an abrasive sponge Use a soft cloth or towel WARNING The following procedures are known to damage transducers They can damage both the electrical safety features and the acoustic performance of the probes Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 82 sur 173 BECM Noveko Do not use the following procedures e Gas sterilization e Ultraviolet sterilization e Dry heat sterilization e Autoclaving e Soakinga transducer in a chlorine bleach solution 22 3 Submerging limits N WARNING During cleaning and disinfection of probes take care of never exceeding the submerging limits indicated on the following figures Probe C360V C360A C360R ut Submerging limit in a fluid Probe L738P IT HH Submerging limit in a fluid Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 83 sur 173 BECM Noveko International Inc Probe C614P Submerging limit in a fluid Probe P320R Submerging limit in a fluid Version 3 d
152. on procedure N WARNING The endo cavity probe supplied with the Imagyne device must be used with a sterile cover over the probe casing which will be in contact with the mucus membranes This cover is for single use only The following disinfection solutions have been tested and their compatibility with the components of the probes has been proved Cidex Cidex plus Cidex OPA It is strongly recommended to use one of these solutions in order to avoid any deterioration during the cleaning and disinfection procedure N WARNING The use of any other disinfecting solution than the ones indicated above is dangerous as it may damage the probe components Check the list of specified agents carefully In order to ensure proper cleaning and disinfection for endo cavity probes please follow the following procedure 1 After every patient examination remove the single use sterile cover and throw it away Wipe the ultrasound transmission gel off the probe Unplug the probe connector from the system Wipe the probe and cable with a soft clean cloth that has been damped in a solution of mild soap and water Follow carefully the medium level disinfection instructions indicated by the disinfectant manufacturer Remove any cleaning solution residue with a soft clean cloth damped in sterile water Air dry or dry with a soft clean and dry cloth MoOouBRUNM N WARNING The specified disinfectants have been tested for compatibility with the probe c
153. one marker to another from tip to end in order to adjust the arrow s length or its angle The active marker is white Click the left Select button to validate To reposition the whole arrow click on the line and drag the arrow with the trackball Validation of the new position by the left Select button 5 arrows are available on one image 15 1 6 Annotation Contextual menu Click on the key Annotation in the contextual measure menu to position an arrow and a text on the image Entering of a free text in the text box with the alphanumeric keyboard Display of the list of pre entered available user annotations by clicking Select with the Right button Click Select on the wanted annotation The annotation is positioned at the place of the curser Click on the annotation with the left Select button to replace it Validation of the new position by clicking Select with the left button See chapter 5 4 on how to add new annotations in each application In the Setting menu the choice between adding the textbox before the arrow or in the reverse order can be made see chapter 5 4 10 annotations can be placed on one image Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 56 sur 173 BECM Noveko 15 1 7 Select Contextual menu Click on the key Select in the contextual measure menu to pass successively from one measurement item on the screen to another The selected measurement is highlighted The selected measure
154. oveko 15 Measures Key number 19 Measurements can be made on live images on cine loop images and sequences see chapter 13 about Freeze and Cineloop mode as well as on stored and loaded images and sequences see chapter 14 Activation and deactivation of Measure controls by pressing the key Measure Key number 19 When in live mode this will automatically freeze the image When playing a Cineloop sequence measures can be made without freezing the sequence The available measures depend on the imaging mode Display of the contextual Measure menu according to the imaging mode The contextual measurement menu contains the general measures For application specific measures use the Protocol function see chapter 18 The device is ready for making the first measurement immediately If a stored image with one or more measures is loaded these measures can be corrected and or remade before the image is being stored again The procedure for correction of measures is the same as for new measures The image with the corrected and or remade measurement can be stored again See chapter 14 1 and 14 2 for the storing procedures Exit of the measure menu by clicking the key Measure 15 1 Measures in B CFM and Anatomic M Modes The results of the measurements are displayed in the lower left corner of the screen If the box B measures Values on US image is ticked on the Setting page see chapter 5 4 the results will be displayed on the ultrasound
155. ower not listed above the recommended separation d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTE 3 The use of cables or accessories different from those specified by ECM may have as a consequence an increase of emission or a decrease of immunity of the Imagyne equipment Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 91 sur 173 BECM Noveko 26 Annex Ill Acoustic power Probe model C360V Mode B mode 2D TIS TIB Index label MI Non scan Non TIC can z 2 Aaprt lt 1 cm Aaprt 1cm scan Maximum Index Value 0 90 0 12 a Pra MPa 1 58 P mW 8 6 a Min Palz lea 5 1 Ze cm l Zbp cm Associated acoustic 2 cm parameters z at max loi al cm 6 deql b cm fawf MHz 3 05 3 05 a Dim Aner Xx 21 a Y 13 a ty Hs 0 38 prr Hz 32 Other information Dr at max lpi 2 97 deq at max lpi cm loa at max MI W cm 117
156. plication than the one specified since the probe type and frequency are related to the clinical application This can lead to bad diagnostic resulting from a non adapted image quality It can also lead to useless irradiation of the patient which is contrary to the ultrasound imaging safety guidelines All probes provided with the Imagyne device are compliant with the standard ISO 10993 1 concerning biocompatibility of components used for probe manufacturing References for Biopsy needle guides Provider CIVCO www civco com Linear L738P Bracket reference Civco 612 085 to be used with needle guide 610 608 compatible with the needles 8 5FR and gauge 14 to 23 except gauge 19 This bracket reference is a re usable bracket Endo cavity E610A Reference bracket and needle guide Civco 610 604 or 610 605 compatible with needles gauge 16 to 18 Endo cavity E610R Reference bracket and needle guide Civco 610 987 or 610 988 compatible with needles gauge 16 to 18 Provider PROTEK www protekmedical com Convex C360V and C360A Bracket reference Protek 7138 to be used with needle guide ref 4222 22 Ga ref 4218 18 Ga ref 4216 16 Ga This bracket reference is a re usable bracket needle guides are disposable See chapter 6 11 on Biopsy needle guide in B imaging 2 8 2 Inspection of probes Warning Before each use inspect the transducer lens case and cable Check for cracks or other damages that may allow liquids to enter the tr
157. pots and drag the ellipse with the trackball Validation of the new position by the left Select button The distance is composed of two markers and several small spots Click on one of the markers and place it at the wanted place with the trackball Validation of the position by the Select button left or right Place the second marker with the trackball at the wanted place Click on the right Select button to pass from one marker to another in order to adjust the distance The active marker is white Click the left Select button to validate To reposition the whole distance click on one of the small spots and drag the distance with the trackball Validation of the new position by the left Select button The result of the volume measurement is displayed at the bottom left corner of the screen One volume measurement is available on one double image See chapter 6 12 for further information on the B Dual Mode 15 1 5 Arrow Contextual menu Click on the key Arrow in the contextual measure menu to position an arrow on the image The arrow is composed of two markers the tip and the end and a line connecting them The curser is trapped by the first marker Place the first marker at the wanted place with the trackball Validation of the position by the Select button left or right Place the second marker with the trackball at the wanted distance The arrow can turn at 360 around the tip or around the end Click on the right Select button to pass from
158. r Recommended separation distance d L24P 150 kHz to 80 MHz Conducted RF 3 Vrms 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz d 1 2V P 80 MHz to 800 MHz Radiated RF 3 V m 3 V m IEC 61000 4 3 d 2 34 P 800 MHz to 2 5 GHz 80 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol K NOTE 1 t 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTE 3 The use of cables or accessories different from those specified by ECM may have as a consequence an increase of emission or a decrease of immunity of the Imagyne equipment a Field strengths from fixed transmitters such as base station for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered
159. r Manual RI Speed Systole Speed Diastole S D Acceleration Acceleration Time Acceleration APPLICATION PEDIATRICS Mode M Organ Measurement Left Renal Artery Heart Rate Right Renal Artery Heart Rate Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 161 sur 173 BECM Noveko APPLICATION SMALL PARTS Mode B CFM Organ Measurement Result Testes Width W xH x D x Pi 6 Height Volume Depth Thyroid Width W x H x D x 0 479 Height Volume Depth Breast Width W xH x D x Pi 6 Height Volume Depth APPLICATION SMALL PARTS Mode PW Organ Measure tool Breast Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Acceleration Doppler Auto RI PI Speed Systole Speed Diastole S D Doppler Manual Trace RI PI Speed Systole Speed Diastole S D Doppler Manual RI Speed Systole Speed Diastole S D Acceleration Acceleration Time Acceleration APPLICATION SMALL PARTS Mode M Organ Measurement Breast Heart Rate Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 162 sur 173 BECM Noveko APPLICATION UROLOGY Mode
160. r the above listed protocols For measurements composed of three parts for instance Left and Right Ovary Start by making the first two distance measurements Width Height as described above Defreeze and scan Freeze again when the wanted cut is found Load the last measurement Depth by clicking left Select and make the third distance measurement See the list of the content of the gynecology protocol in chapter 29 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 70 sur 173 BECM Noveko 18 8 Protocols in obstetrics In the Preset menu select the application Obstetrics Select the imaging mode B M CFM PW Press Protocols The available protocol calculations are displayed in a list in the window on the left of the screen When passing the curser on the list the protocol calculations are highlighted successively To load a protocol calculation click Select The measurement tool is ready on the image The curser is trapped by the first marker of the measurement Place the first marker at the wanted place with the trackball Validation of the position by the Select button left or right Place the second marker with the trackball at the wanted place Click on the right Select button to pass from one marker to another in order to adjust the measurement The active marker is white Click the left Select button to validate To reposition the whole measurement click on one of the small spots and drag the mea
161. re active See chapter 16 about Post processing for details When the image is frozen the contextual Freeze menu is displayed This menu is depending on the used imaging mode Print Printing of the currently displayed image by pressing the key Print in the contextual Freeze menu If several printers are available and if the box Select Printer at Print Image is ticked see chapter 5 4 the device proposes a selection of printers Otherwise printing is made on the default printer It is possible to do measures on frozen images and sequences See chapter 15 for details Annotations can be added in Freeze mode See chapter 5 4 on how to enter new annotations in each application Display of the list of available annotations by clicking the Right Select button Pass the curser on the list and click Select right or left button on the wanted annotation to add it on the image The annotation is positioned at the place of the curser If needed click on the annotation with the left Select button and drag it to a new position Validation of the new position by clicking Select with the left button 10 annotations can be placed on one image A frozen image or sequence can be zoomed See chapter 6 6 for details Defreeze of the image and return to live mode by clicking freeze Key number 3 Dual When in Dual See chapter 6 12 it is possible to defreeze one of the two images displayed simultaneously on the screen by using the keys Unfreeze Left or Unfre
162. ric convex 4D probe 4DC540V should always be connected on the first connector port Probe 1 Other probes can be connected on all connector ports 4 2 Adjustment of keyboard height To adjust the vertical position of the keyboard unlock the keyboard by lifting the handle located on the left hand side of the keybaord between the probe holders After adjusting the keyboard position by lifting or pushing down the keyboard release the handle to lock the keyboard in the desired position 4 3 Starting of the device Warning Before starting the equipment check the voltage selection situated at the back of the equipment To change the voltage selection 115 or 230 VAC take out the fuse drawer and turn it upside down before putting it back After re inserting the fuse drawer the selected voltage is displayed in the window provided for this purpose Warning Only the power cord supplied by ECM with a ground connection must be used to power the device Never use a power cord without proper ground connection To start the equipment turn on the general power switch with the following symbol O I situated on the lower rear part of the device Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 20 sur 173 BECM Noveko Then press the On off switch with the following symbol D situated on the middle rear part of the device Then wait until the system starts and displays the user interface on the screen The I
163. ry Distance Surface Stenosis Distance Stenosis Surface Distance Surface Stenosis Distance Stenosis Surface Distance Surface Stenosis Distance Stenosis Surface Distance Surface R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 164 sur 173 BECM Noveko APPLICATION VASCULAR B CFM Abbreviation Organ Measure tool Left Ulnar Artery Right Ulnar Artery Left Radial Artery Right Radial Artery Left Ext lliac Artery Right Ext Iliac Artery Left Com Femoral Artery Right Com Femoral Artery Left Profonda Artery Right Profonda Artery Left Tibioperoneal T Right Tibioperoneal T Left Peroneal Artery Right Peroneal Artery Left DP Artery Version 3 du 16 07 2012 Left Ulnar Artery Right Ulnar Artery Left Radial Artery Right Radial Artery Left Exterior Iliac Artery Right Exterior Iliac Artery Left Common Femoral Artery Right Common Femoral Artery Left Profonda Artery Right Profonda Artery Left Tibioperoneal Trunk Right Tibioperoneal Trunk Left Peroneal Artery Right Peroneal Artery Left Dorsalis Pedis Artery Stenosis Distance Stenosis Surface Distance Surface Stenosis Distance Stenosis Surface Distance Surface Stenosis Distance Stenosis Surface Distance Surface Stenosis Distance Stenosis Surface Distance Surface Stenosis Distance Stenosis Surface Distanc
164. ry Left Profonda Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Right Profonda Artery Right Profonda Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Left Tibioperoneal T Left Tibioperoneal Trunk Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Right Tibioperoneal T Right Tibioperoneal Trunk Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Left Peroneal Artery Left Peroneal Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 170 sur 173 BECM Noveko APPLICATION VASCULAR Mode PW Abbreviation Organ Measure tool Version 3 du 16 07 2012 Manual Acceleration Acceleration Right Peroneal Artery Right Peroneal Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration
165. s activated Move the trackball to adjust the size The gate size in mm is displayed on the right of the screen Click Select with the right button to change between adjustment of size and position Click Select with the left button to validate the new position and or size of the gate line and to unleash the cursor The PW gate line is yellow when position and size are validated To reactivate the adjustment of position or size of the gate place the cursor on the line and click Select left or right button Follow the description above It is also possible to adjust the size of the gate by clicking the keys Gate Size and Gate Size in the contextual PW menu The size of the gate in mm is displayed on the right of the screen 9 2 Frequency Key number 17 The PW frequency is adjusted with the rocker switch Frequency Upwards activation of the Frequency rocker switch increases the frequency Downwards activation of the Frequency rocker switch decreases the frequency The updated frequency is displayed at the right of the screen Each probe has 5 preset frequency steps within the bandwidth in PW Mode 9 3 Gain Key number 6 The PW Gain is adjusted by turning the PW knob Turn the PW knob clockwise to increase the Gain Turn the PW knob anticlockwise to decrease the Gain The updated gain level is displayed on the right of the screen Min gain 0 Max gain 100 9 4 Emission Power Contextual menu Increase and decrease of the PW emission po
166. s and authors according to each application The activation of existing User Protocols is made on the patient page See the paragraphs 18 Protocols and 19 Patient File for details Annotations The lower left half of the window allows the user to enter annotations in each Application Select the wanted application in the upper half window in the list In the lower half window enter the text in the empty field with the alphanumeric keyboard Add the annotation by clicking Add The annotation is added to the list Click Beginning Before After or End to change the order of annotations Click Delete to erase the selected annotation The annotations are available in Freeze mode Measure mode and Protocols Activations of the annotations by clicking the Right Select button The list is displayed Click Select on the wanted annotation The annotation is positioned at the place of the curser Click on the annotation with the left Select button to reposition it Validation of the new position by clicking Select with the left button 46 annotations can be added in each application 10 annotations can be placed on one image See also chapter 13 and 15 1 6 Exit of the user protocols and annotations page and return to Settings by pressing the key Clear Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 28 sur 173 BECM Noveko Obstetric Report mode GA In OB application possibility to use all available measures to calcul
167. s ee mulet Aaaa e bee EE 60 15 4 9 Delete all Contextual menu 60 15 5 ESI SD O O r este deu 60 15 5 1 Distance Contextual menu ee tette tinet Ya TRES doen a Le ERE ENS UEER E D pues alat vias 60 15 5 2 Ellipse Contextual menu 60 15 5 3 Trace Contextual menu 61 15 5 4 Arrow Context al EE 61 15 5 5 Annotation Contextual menu 61 15 5 6 Select Contextual EE 61 15 5 7 Print Contextual menu 61 15 5 8 Delete Contextual menu orinn aaae Ta enZ RTE aea tat eo v Ee DU ER oue eH EENS 61 15 5 9 Delete all Contextual menu 61 16 POST PROCESSING se 62 16 B MODE EE 62 16 1 1 Ee LCE 62 IPAE nc 62 16 2 T neo cH T 62 e Een 62 16 351 CEM seco c E X X 62 16 3 2 B COMENOIS EE EU 62 ua Eoo RES 63 EID ME Umm RE R E R 63 16 4 2 B CONOIS m E 63 aate GRM PW AIM ODE EAE EAE E EA TA A ti roter E E EA E AE te nn n ul 63 16 5 1 A 01 1 1 0 CE PE PR 63 ErraduNsu M 63 16 5 3 B COMENOIS p ERS 63 16 6 CW MODE n 63 S La Mure 63 16 6 2 B C ODLEOIS ebe e LEM E M
168. s is to be avoided Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 113 sur 173 BECM Noveko 27 2 Detailed obstetrical tables AC Jeanty FG 5 mm 50 mm 95 mm 2 SE EE RN E 3 100 110 5096 mm 9796 mm 95 0 108 8 121 6 134 0 146 6 158 8 171 0 183 0 194 7 206 3 218 0 229 3 240 6 251 6 262 6 273 3 283 7 294 4 304 6 314 8 324 8 334 5 344 3 353 8 363 0 3722 380 0 118 0 29 2 140 4 51 4 162 3 173 0 83 6 194 0 204 4 214 5 224 5 234 4 244 0 253 6 263 0 272 2 281 2 290 2 298 8 307 4 316 0 324 7 332 4 339 0 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 114 sur 173 BECM Noveko AC Chitty drvd FG Age 12w0d 25w0d 26w0d 27w0d 28w0d 29w0d 30wOd 31w0d 32w0d 34w0d 35w0d 36w0d 37w0d 38w0d 39w0d 40w0d 41w0d 42w0d Sm Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 115 sur 173 BECM Noveko AC Chitty Pltd FG Sim 1640 91 4 06 1 120 8 17 0 102 2 117 7 133 3 18 0 12 9 29 3 145 7 19 0 123 5 140 7 158 20 0 33 9 52 1 170 2 21 0 144 3 163 3 182 3 22 0 54 6 74 5 194 4 23 0 64 8 85 5 206 3 24 0 174 9 196 5 218 1 25 0 84 9 207 3 229 7 26 0 194 7 218 241 3 27 0 204 4 228 6 252 7 28 0 214 239 264 1 29 0 223 5 249 3 275 2 30 0 232 8 259 5 286 2 31 0 241 9 269 5 297 1 32 0 251 279 4 307 9 33 0 259 8 289 1 318 4 34 0 268
169. s made by ECM cannot be deleted Exit of the Preset and Application menu by pressing the key Preset Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 66 sur 173 BECM Noveko 18 Protocols Key number 18 Activation and deactivation of the list of protocols by the key Protocols Key number 18 Protocols mean application specific measures and tables The available protocols depend on the selected Application and Preset see chapter 17 and on the selected mode The protocol Factory contains all standard tables and measures according to each application The user can decide individually which of these tables and measures should be used by entering a user protocol See chapter 18 2 1 After activation of the protocols the available protocols are displayed in a window on the left of the screen The contextual Protocol menu is displayed on the screen Protocols can be used either with an open patient file or without an open patient file See chapter 19 about patient files When a patient file is open with a report the results of each measurement and table are automatically added to the report of the patient See chapter 20 about reports Each time a measure from the protocol is made the image can be stored see chapter 14 The image with the measure from the protocol can be printed directly by the key Print in the contextual protocols menu Protocol measurements on stored and reloaded images can be correct
170. same adjustments frequency depth etc Certain changes in these adjustments delete the frozen image The live image is updated Return to the dual display by the key Dual Select and the frozen image is updated To defreeze in Dual mode after having frozen the active image by pressing Freeze use the keys Unfreeze Left or Unfreeze Right in the contextual Dual Freeze menu Exit of Dual mode and return to the standard B image by pressing the B knob 6 13 Emission power Contextual menu Increase and decrease of the B emission power by the keys Power and Power in the contextual B menu The updated emission power scale is displayed on the right of the screen Min power 10 dB Max power 0 dB 1 dB step Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 33 sur 173 BECM Noveko 6 14 Ima Clean Contextual menu Activation of the function Ima Clean Speckle Reduction by the key Ima Clean in the contextual B menu in the contextual B menu When the Ima Clean is active the key is highlighted in red Access to the Ima Clean sub menu by the key Ima Clean Tools in the contextual B menu Exit of the sub menu by pressing the key Exit 6 14 1 Edge Ima Clean contextual submenu Adjustment of the enhancement of edges and boundaries by the keys Edge and Edge 6 14 2 Speckle Reduction Ima Clean contextual submenu Adjustment of the reduction of the speckle by the keys Speckle Reduction and Speckle Reduction
171. selected place on the image A rectangle appears on the screen The rectangle can be repositioned immediately with the trackball Validation of the position by the left Select button The system automatically detects the intima displayed with a purple line inside the box The size of the rectangle should be adjusted so that it includes both the upper and lower artery walls Click on the side of the rectangle to adjust the size with the trackball Using a too small rectangle would lead to irrelevant measurement The results of the following measurements and calculations are displayed in the lower left part of the screen ntima Media Thickness Standard deviation Width of the vessel The measure is made on the lower intima wall In order to measure the upper intima wall make an image rotation see chapter 6 19 This will put the image upside down while the measuring rectangle stays the same Follow the above described procedure This measurement is only indicative and is highly user dependent 18 3 2 Measurement of 3D Volume This measurement is composed of three parts and used for a volume calculation Start by making the first two distance measurements Width Height as described above Defreeze Freeze again when the wanted cut is found Load the last measurement Depth by clicking left Select and make the third distance measurement The volume calculation is made automatically by the device Version 3 du 16 07 2012 R f CD MA Manuel
172. stored images and sequences during the current application can be viewed If a previously stored sequence is reloaded and modified it can be stored again If the sequence was previously linked to a patient file at the moment of the new storing the device will ask if the sequence should be stored in the same directory When you click Yes the modified sequence will be stored in the same directory If you click No the sequence will be stored as a non attached file 14 3 Review Key number 20 All images and sequences stored in the PC memory can be reviewed and post processed Press the key Review to make the Review window composed of two columns appear on the screen The first column contains the list of patients see chapter 19 A patient file can include one or several reports as well as images and sequences Click on the successive crosses to see all elements The available images and sequences are listed in the second column Possibility to search a specific patient by entering a text with the alphanumeric keyboard in the black box under the title Search and pressing OK or Enter If the text corresponds to a patient file this one is highlighted in the list Otherwise an error message occurs Enter another text to continue the search Beneath the list of patients is a list of files which are not attached to a patient file Click on each file to see the list of non attached stored images and sequences in the second column The contextual
173. sults of the following calculations appear below the others at the bottom left corner of the screen V Sys Systole speed V Dias Diastole speed 15 3 3 Manual Trace measure Contextual menu Click on the key Manual Trace in the contextual measure menu to activate the manual trace calculation The system automatically detects the number of available complete cardiac cycles Place the curser on the wanted place on the PW Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 58 sur 173 BECM Noveko specter and click Select Trace the PW envelope manually The system automatically detects when a complete cycle is traced Click on the right Select button to pass from one marker to another in order to adjust the positions The active marker is highlighted in red Click on the left Select button to validate To adjust the trace place the curser on the wanted place on the envelope trace and click Select in order to adjust the trace Click Select with the left button to validate The results of the following calculations are displayed at the bottom left corner of the screen Rate RI Resistance Index S D Systole Diastole PI Pulsatility Index If the angle correction see chapter 9 7 is activated either during the examination on live images or during post processing see chapter 16 3 2 the results of the following calculations appear below the others at the bottom left corner of the screen V
174. surement with the trackball Validation of the new position by the left Select button The result of the measure is displayed in the middle of the window The author of the table is displayed in the middle of the window beneath the result of the measurement If several authors are available for a table click on the line Authors The selection of Authors is displayed Click Select on the wanted author If the measure is interpreted by a table the result of the table is displayed in the bottom of the window for instance the gestational age When no patient file is open the system calculates automatically the LMP and EDD displayed below the result of the measurement according to the selected author The obstetrical tables are generally limited to a certain number of gestational weeks most often 42 weeks The calculations of longer pregnancies or measurements exceeding the standard tables are possible but the results are then displayed with a specific indicator The following character is used on the screen display in examination reports and on print outs In the graphs the extrapolated zones are indicated in red See the list of the content of the obstetrics protocol in chapter 29 18 9 Protocols in Pediatrics Same procedure as for the above listed protocols See the list of the content of the pediatrics protocol in chapter 29 18 10 Protocols in Small parts application Same procedure as for the above listed protocols For measure
175. t appropriately in order to obtain the necessary diagnostic information with a minimum risk for the patient In order to do this the operator has two indexes displayed on the screen MI and TI respectively Mechanical Index and Thermal Index enabling him to continuously have an indication of the acoustic transmit power level Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 10 sur 173 BECM Noveko The relationship between different parameters of acoustic power and biological evaluation criteria is not well known today Two fundamental phenomena have been identified mechanical and thermal through which ultrasounds might have biological effects The MI and TI indexes have been developed to take these phenomena into account and to give the user immediate information on the potential mechanical or thermal biological effects Please notice that these indexes do not take accrued effects into account The MI index mechanical index is related to the spatial peak of the maximum rarefaction pressure providing an indication according to the cavitation effect There is a strong agreement that biological effects can possibly occur with an increase of the maximum rarefaction pressure The TI index thermal index is related to the tissue temperature rise and corresponds to the ratio between the total acoustic power and the acoustic power required to raise the tissue temperature by one degree Celsius There is no simple mode
176. t by pressing Store Image Sequences can be stored by pressing Store Clip When a calculation or ratio based on the measures which have been made is available this is indicated by a triangle in the protocol list Click on the calculation or the ratio to validate it and add it to the report 19 6 Stop an examination Activation of the patient menu by clicking the key Patient Click Stop in the middle of the patient window The patient file is closed and all fields get empty Exit of the Patient menu by pressing the key Patient or by pressing the key Clear The device returns to the imaging mode with no patient name displayed in the upper right part of the screen Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 75 sur 173 BECM Noveko 20 Report Key number 32 Activation of the function Report by pressing the key Report Key number 32 The report is always linked to a patient It is thus necessary to open a patient file and start an examination in order to get access to the report see chapter 19 4 Return to the imaging mode for measures etc by clicking Report once again or Clear The report stays active until the patient file is closed The report contains the following information from the patient file Name First name Age Birthday Referent doctor This information can be changed in the Patient menu See chapter 19 The report also contains the date of the examination and the operator name
177. t of the sequence A yellow triangle in the Cineloop window indicates the start of the sequence and a green triangle indicates the end of the sequence To reduce the length of the sequence place the yellow triangles with the trackball at the wanted start and the green triangle at the wanted end Press Store clip Only the part of the sequence between the two triangles will be stored If a sequence is stored while a patient file is open the sequence will be stored in this file If an examination has been started meaning that a report is open the sequence is stored in the report see chapter 20 If there is no open patient file the sequence will be stored as a non attached file When the sequence has been stored a thumbnail with the temporary name of the sequence appears above the contextual menu example C090624 1134 3 C for clip 09 for the year 06 is the month 24 the date 11 the hour of storing 34 is the minute of storing and 3 for the number of sequences stored at the same time The thumbnail stays on the screen during the current application The sequence can be loaded by clicking on the thumbnail with the trackball and Select Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 52 sur 173 BECM Noveko If several images and sequences of the same application are stored these are all displayed by thumbnails above the contextual menu By clicking on the arrows at the left and or the right all thumbnails of
178. te Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time Heart Rate Time R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 173 sur 173
179. terior Tibial Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Right PT Artery Right Posterior Tibial Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Doppler Auto RI PI Speed Systole Speed Diastole S D Doppler Manual RI Speed Systole Speed Diastole S D ICA CCA Ratios APPLICATION VASCULAR Mode M Abbreviation L ICA CCA D L ICA CCA S R ICA CCA D R ICA CCA S Measurement Left Com Carotid Artery Left Common Carotid Artery Heart Rate Time Right Com Carotid Artery Right Common Carotid Artery Heart Rate Time Left Ext Carotid Artery Left External Carotid Artery Heart Rate Time Right Ext Carotid Artery Right External Carotid Artery Heart Rate Time Left Int Carotid Artery Left Internal Carotid Artery Heart Rate Right Int Carotid Artery Right Internal Carotid Artery Heart Rate Time Left Vertebral Artery Left Vertebral Artery Heart Rate Time Right Vertebral Artery Right Vertebral Artery Heart Rate Time Left Subclavian Artery Left Subclavian Artery Heart Rate Time Right Subclavian Artery Right Subclavian Artery Heart Rate Time I
180. the understanding of displayed ultrasound images the understanding of how to perform measurements on images or on Doppler spectrums The user must have read the complete user s manual in order to know the instructions needed to operate the equipment He must refer to the user s manual at any time in case of doubt about the use of the device Warning It is mandatory to read the user s manual before starting an examination People which are not trained to ultrasound diagnostic imaging technique must not use the Imagyne equipment 2 1 2 Acoustic power The AIUM American institute of Ultrasound in Medicine has stated on the use of ultrasound for medical diagnostic that no confirmed biological effects on patients or instrument operators caused by exposure at intensities typical of present diagnostic ultrasound equipments have ever been reported Although the possibility exists that such biological effects may be identified in the future current data indicate that the benefit to patients of the safe use of diagnostic ultrasound outweigh the risks if any that may be present The institute indicates that the benefits of a safe use of diagnostic ultrasound outweigh the risks if any which may be present References Bioeffects considerations for the safety of Diagnostic Ultrasound Journal of Ultrasound in medicine Vol 7 Number 9 American Institute of Ultrasound in Medicine Bioeffects Committee Warning Safe use means that the ultrasound
181. timated Fetal Weight Hadlock EFW hc ac fl bpd Estimated Fetal Weight Hadlock EFW bpd ac Estimated Fetal Weight Shepard EFW bpd thd Estimated Fetal Weight Hansmann EFW ac Estimated Fetal Weight Cambell EFW bpd fta fl Estimated Fetal Weight Osaka EFW bpd aptd ttd fl Estimated Fetal Weight Tokyo FL HC Ratio HC AC Ratio FL AC Ratio FL BPD Ratio Amniotic Fluid Index HC from BPD amp OFD CI Cephalic Index GA Average Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 159 sur 173 BECM Noveko APPLICATION OBSTETRICAL Mode PW Abbreviation Organ Measure tool Author Fetal Heart Rate GA Average Fetal Aorta Doppler Auto Schaffer Mai Doppler Manual Schaffer Mai Doppler Manual Trace Schaffer Heart Rate Mai Acceleration Left Uterine Doppler Auto Schaffer Doppler Manual Schaffer Doppler Manual Trace Schaffer Mai Heart Rate Acceleration Right Uterine Doppler Auto Schaffer Doppler Manual Schaffer Doppler Manual Trace Schaffer Mai Heart Rate Acceleration MCA Middle Cerebral Artery Doppler Auto Mai Schaffer Doppler Manual Mai Schaffer Doppler Manual Trace Schaffer Mai Acceleration UA Umbilical Artery Doppler Auto Mai Schaffer Doppler Manual Mai Schaffer Doppler Manual Trace Schaffer Mai Heart Rate Acceleration Doppler Auto RI Pl Doppler Manual RI Doppler
182. tion Acceleration Right Int Carotid Artery Right Internal Carotid Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Left Vertebral Artery Left Vertebral Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 167 sur 173 BECM Noveko APPLICATION VASCULAR Mode PW Abbreviation Organ Measure tool Manual Acceleration Acceleration Right Vertebral Artery Right Vertebral Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Left Subclavian Artery Left Subclavian Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Right Subclavian Artery Right Subclavian Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration Innominate Artery Innominate Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Time Speed Flow Manual Acceleration Acceleration
183. ton to validate To reposition the markers place the curser on one of them and click Select to activate it Follow the procedure above for the validation of the new position The result of the rate measurement in bpm is displayed at the bottom left corner of the screen One rate measurement is available on an M image 15 2 2 Distance and time interval Contextual menu Click on the key Distance in the contextual M menu to activate the measurement of distance and time interval The distance measurement is composed of two markers and several small spots The curser is trapped by the first marker Place the first marker at the wanted place with the trackball Validation of the position by the Select button left or right Place the second marker with the trackball at the wanted place Click on the right Select button to pass from one marker to another in order to adjust the distance The active marker is white Click the left Select button to validate To reposition the whole distance click on one of the small spots and drag the distance with the trackball Validation of the new position by the left Select button The result of the distance measurement is displayed at the bottom left corner of the screen The time interval is calculated automatically depending on the distance and the result is displayed at the bottom left corner of the screen One distance time interval measurement is available on an M image 15 2 3 Arrow Contextual menu Se
184. transformer or comply themselves with the electrical safety standard EN 60601 1 Otherwise the patient electrical safety is no longer ensured N WARNING To ensure the electrical safety of the device never touch any parts of an electrical non medical device situated in the patient s environment at the same time as the patient To ensure the electromagnetic compatibility of the equipment N WARNING The exclusive use of cables specified by ECM in this manual is mandatory to ensure the compliance of the Imagyne equipment with the electromagnetic compatibility standard EN 60601 1 2 21 1 Management of out puts Video out USB DVI See the summarizing table below Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 78 sur 173 BECM Noveko International Inc Summarizing table Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 79 sur 173 BECM Noveko 21 2 Printing of reports on USB connected thermal printers By USB cable for SONY UP D897 printers Adjustment of printing parameters Install the USB connected thermal printer Press the key Setting on Imagyne and click on Add printer Follow the instructions If needed insert the printer driver in the CD DVD drive Press the key Setting on Imagyne In the lower middl
185. trum on a timescale The B image is frozen simplex mode Display of the contextual CW menu The following CW parameters are always displayed on the screen in the lower right part Gain Frequency Power PRF The other parameters are displayed when they are changed in order not to encumber the screen these other parameters swap place on a First in First Out basis During the change of each parameter the changed value is displayed in yellow Deactivation of the CW mode by pressing the B knob NB CW is only available on the phased array probe using the cardiology application 11 1 Positioning of the CW line The CW line can be moved with the trackball to the wanted place immediately after turning on the CW mode The line is white when the repositioning is activated Click Select with the left button to switch between pre CW with the B image active and CW Click Select with the right button to validate the new position and to unleash the cursor The CW line is yellow when the position is validated To reactivate the adjustment of position of the line place the cursor on the line and click Select with the right button Follow the description above 11 2 Gain Key number 6 The CW Gain is adjusted by turning the PW knob Turn the PW knob clockwise to increase the Gain Turn the PW knob anticlockwise to decrease the Gain The updated CW gain level is displayed on the right of the screen Min gain 0 Max gain 100 11 3 PRF Key number
186. tual menu The mode CFM velocity is activated by default when turning on the CFM mode The color scale which is also the PRF scale see chapter 8 6 is graduated in two parts in order to distinguish the two directions of the flows towards and away from the transducer Slow flows are depicted in dark red or dark blue high speeds are passing from blue to white or from red to yellow depending on the direction When in CFM Power return to CFM Velocity by clicking on the key CFM Mode in the contextual CFM menu 8 1 1 1 Invert Contextual menu Inversion of the colors attributed to the two directions of flows red and blue nuances by the key CFM Invert in the contextual CFM menu NB This function is only active in CFM velocity 8 1 2 CFM Power Contextual menu When in CFM Velocity the CFM Power mode is activated by the clicking on the key CFM Mode in the contextual CFM menu In CFM Power Mode the color scale is graduated from red to yellow Slow flows are depicted in dark red high speed in yellow independently of directions 8 1 2 1 Power scale Contextual menu Increase and decrease of the color scale nuances by the keys Power scale and Power scale in the contextual CFM menu The value of the color scale is updated on the color scale itself Min color power scale 1 Max color power scale 100 NB This function is only active in CFM power 8 2 Positioning and size of the CFM box The CFM box can be moved with the trackball to t
187. u 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 84 sur 173 BECM Noveko International Inc Probe E610A E610R Submerging limit in a fluid Probe 4DC540V Submerging limit in a fluid Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 85 sur 173 BECM Noveko 23 Labeling of the device Reference label for Imagyne with indication of serial number IMAGYNE A E ECM 126 bd de la R publique C 0459 F 16000 Angoul me Label for power supply and fuse cutout 115 230 V 50 60 Hz 400 VA Fuses 5 A fast blow type DO NOT OPEN Only authorized personal should repair the device Probe label with reference and serial number ECM 126 bd de la R publique F 16000 Angoul me C 0459 Protection packaging label with temperature and humidity precautions for transport and stocking ll DO NOT STACK FRAGILE 60 C Humidity 10 to 85 Storage Temperature 10 C to 60 C BECM Bi Noveko Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 86 sur 173 BECM Noveko 24 Annex 1 Measure accuracy Distance and ellipse perimeter Up to 30 cm lt 5 ou lt 1mm below 2 cm See note 2 Trace perimeter Up to 100 cm lt 596 ou lt 1mm below 2 cm Surface Up to 1000 cm lt 1096 ou lt 40 mm below 4 cm Note 1 The PW Pulsed Wave Doppler spe
188. u 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 156 sur 173 BECM Noveko APPLICATION GYNECOLOGY Mode B CFM Organ Measurement Left ovary Width Height Depth Right Ovary Width Height Depth Uterus Width Height Depth Ovarian follicle Distance 1 Distance 2 Distance 3 Endometrium thickness Thickness APPLICATION GYNECOLOGY Mode PW Organ Measure tool Left Uterine Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Acceleration Right Uterine Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Acceleration Left Ovary Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Acceleration Right Ovary Artery Doppler Auto Doppler Manual Doppler Manual Trace Heart Rate Acceleration Doppler Auto RI PI Speed Systole Speed Diastole S D Doppler Manual Trace RI PI Speed Systole Speed Diastole S D Doppler Manual RI Speed Systole Speed Diastole S D Heart Rate Rate Acceleration Acceleration Time Acceleration Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 157 sur 173 BECM No
189. u can return to the B Mode by pressing the B knob The contextual B menu with 3 sub levels is displayed when using the B Mode The following B parameters are always displayed on the screen in the upper right part Gain Frequency Power Dynamic The other parameters are displayed when they are changed In order not to encumber the screen these other parameters swap place on a First in First Out basis During the change of each parameter the changed value is displayed in yellow 6 1 Depth Key number 16 Increase and decrease of the examination depth by the Depth rocker switch Upwards activation increases the depth downwards activation decreases the depth The updated image depth is displayed at the bottom of the screen to the right The vertical depth scale is graduated by increments of 1 cm The maximum depth depends on the used probe When the Auto Focus function is ticked on the Setting page the frequency and focuses are automatically adapted to the changed depth However manual adjustments are still possible 6 2 Frequency Key number 17 The B frequency is adjusted with the rocker switch Frequency Upwards activation of the Frequency rocker switch increases the frequency Downwards activation of the Frequency rocker switch decreases the frequency The updated frequency is displayed at the right of the screen Each probe has 5 preset frequency steps within the bandwidth in B Mode 6 3 Gain Key number 4 The B Gain applied to th
190. umber 17 The CFM frequency is adjusted with the rocker switch Frequency Upwards activation of the Frequency rocker switch increases the frequency Downwards activation of the Frequency rocker switch decreases the frequency The updated frequency is displayed at the right of the screen Each probe has 5 preset frequency steps within the bandwidth in CFM Mode 8 4 Gain Key number 5 The CFM Gain is adjusted by turning the CFM knob Turn the CFM knob clockwise to increase the Gain Turn the CFM knob anticlockwise to decrease the Gain The updated gain level is displayed on the right of the screen Min gain 1 Max gain 100 8 5 PRF Key number 9 Adjustment of the PRF Pulse Repetition Frequency scale in CFM by the CFM PRF rocker switch situated next to the CFM knob Upwards activation increases the PRF downwards activation decreases the PRF The updated PRF value in KHz is displayed at the right of the screen When in CFM Velocity see chapter 8 1 the PRF color scale in cm s is updated on the left of the screen 8 6 Steering Key number 11 The CFM box can be steered by the rocker switch Steering Upwards activation steers to the left downwards activation steers to the right NB Steering is only possible when using the linear probe 8 7 Reject Key number 10 Adjustment of the rejection of low velocities by the Reject rocker switch The reject indicator is displayed on the right of the screen as Min Vel Min reject 1
191. updates the connected external media Archive Store Possibility to archive and store patient files patient reports images and clips The selection can be made by Date by entering the start and end date or by Patient by entering the start patient and the end patient Select the external device USB or DVD Press Archive In this case the patient files are copied and archived and the reports together with linked images are archived and deleted from the Imagyne device s hard disk The patient files stay on Imagyne s hard disk If you tick the box Delete patient after archive before archiving both reports with images and patient files are archived and then deleted from Imagyne hard disk When ticking the box Archive Clip before archiving the reports together with both linked images and linked clips are archived on the external device and then deleted from Imagyne s hard disk If an import of patient files is made after archiving two patient files for the same patient could then be present The device will automatically ask if one file should replace the other if a new patient file should be created for the imported file or if the two patient files should be merged Store all patients Possibility to make a back up of all patients reports images and clips on Imagyne s hard disk Consult Reports Possibility to consult archived examination reports made on Imagyne on external media The column named Drive contains the list of external media
192. ures The probes provided with the device are compliant with the security standards concerning surface temperatures The probes have been designed in order to never let the surface temperature exceed 41 C Warning The Imagyne device has not been designed to be used together with a high frequency surgical device A risk of patient burn might exist in case of failure in connection of the neutral electrode of the surgical high frequency device 2 9 End of product life of the device At the end of life of the device due to a reject or a definitive end of use the device must be recycled Take care of bringing the device to a certified recycling center or return it to the distributor The distributor s address is found on the first page of this manual Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 18 sur 173 BECM Noveko 3 Installation of the equipment The Imagyne device must be installed on site by a person authorized by ECM Warning Never try to open the equipment Only an ECM qualified customer service engineer is authorized to open the system and service it gt Warning After installation check that the mechanical components LCD screen screen arm are properly attached and that there is no risk for them to fall or move in unexpected ways gt Warning When moving the device take care of avoiding any mechanical shock or collision due to the important inertia of the equipment gt
193. user protocols menu Deactivation of the user protocols by clicking Setting or Clear The device returns to the Setting menu Click Setting or Clear once again to return to the imaging mode Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 68 sur 173 BECM Noveko NB After creation of a new user protocol this protocol will not be activated automatically See the chapter 18 2 4 on how to activate the user protocol 18 2 5 Activation of user protocols The user protocols are activated in the Patient menu see chapter 19 It is possible to activate a user protocol without opening a patient file Start by selecting the application in which the user protocol is made see chapter 17 1 about applications and presets Press the key Patient The Patient screen window is displayed To activate a user protocol click on the arrow in the protocol window in the middle of the screen on the right Select the name of the wanted user protocol in the list Press the key Patient to exit the Patient page and return to the imaging mode When activating the protocol menu by clicking Protocol the content of the selected user protocol is displayed See chapter 19 on how to activate a user protocol with an open patient file 18 3 Protocols in general application In the Preset menu select the application General and the wanted preset see chapter 17 Select the imaging mode B M CFM PW CW Press Protocols The available protoco
194. veko APPLICATION GYNECOLOGY Mode M Organ Measurement Left Uterine Artery Heart Rate Right Uterine Artery Heart Rate Left Ovary Artery Heart Rate Right Ovary Artery Heart Rate Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2_02 EN v3 Page 158 sur 173 BECM Noveko APPLICATION OBSTETRICAL Mode B CFM Abbreviation Organ Author CRL Crown Rump Lenght Hadlock Hansmann Osaka Rempen Robinson Tokyo BPD Biparietal Diameter Chitty O O CFEF Hadlock Hansmann Osaka Tokyo GS Gestational Sac Rempen Hansmann Tokyo AC Abdominal Circumference Chitty drvd Chitty pltd CFEF Hadlock Jeanty Tokyo FL Femur lenght Chitty CFEF Hadlock Hansmann Osaka Tokyo HC Head circumference Chitty drvd Chitty pltd CFEF Hadlock Hansmann Head Area Head Area Chitty TAD Transverse Abdominal Diameter CFEF ThD Thoracic Diameter Hansmann FTA Fetal Trunk cross sect Area Osaka APAD Ant Post Abdominal Diam Merz Trans amp Ant Trunk Diam Tokyo Clavicle Clavicle Yarkoni NT Nuchal Tranlucency OFD Occipito Frontal Diameter Chitty Hansman Facial angle Facial angle EFW ac fl Estimated Fetal Weight Hadlock EFW bpd ac fl Estimated Fetal Weight Hadlock EFW hc ac fl Es
195. vice is automatically selecting the maximum number of complete cycles available in the PW specter indicated by a white horizontal line To adjust the number of cycles place the trackball on either the left or the right marker in the PW specter and click Select left or right button After adjustment of one marker click Select with the right button to pass form one marker to the other The active marker is white Validation of the new position by the left Select button 15 3 2 Semi automatic measure Contextual menu Click on the key Semi automatic in the contextual measure menu to activate the semi automatic calculation The curser is trapped by the first marker in the PW specter Place the marker on the wanted place and click Select left or right button to validate Place the second marker at the wanted place with the trackball Click on the right Select button to pass from one marker to another in order to adjust the positions The active marker is white Click the left Select button to validate To reposition the markers place the curser on one of them and click Select to activate it Follow the procedure above for the validation of the new position The results of the following calculations are displayed at the bottom left corner of the screen RI Resistance Index S D Systole Diastole If the angle correction see chapter 9 7 is added either during the examination on live images or during post processing see chapter 16 3 2 the re
196. w stored in the device If a selected calculation necessitates one or more measures that were not yet included in the protocol an error message occurs when saving the protocol Dependent calculations are missing Do you want to add them Click OK and the device will automatically include them 18 2 2 Delete a user protocol Select the wanted user protocol in the list in the second column Click Select in the window Delete the selected protocol It is impossible to delete the protocol Factory entered by ECM 18 2 3 User defined items Possibility to add user defined distances elliptic surfaces and elliptic volumes to both factory protocols and user protocols Select the application in the upper left list where the user defined item should be added Click on the window User Defined Items Click New Enter the name of the item and select the wanted measurement by using the scroll bar distance elliptic surface or elliptic volume Click Apply Click Cancel to cancel the operation Click OK to exit the user defined protocol items The new item now appears in the list of protocol measurements in the selected application It can be used in the factory protocol where it will be at the end of the list or selected and used in a user protocol For deleting a user defined item click on the window User Defined Items Select the user defined item that should be deleted in the list and click Delete Click OK to exit the user defined items 18 2 4 Exit of
197. wer by the keys Power and Power in the contextual PW menu The updated emission power scale is displayed on the right of the screen 9 5 PRF Key number 13 Adjustment of the PRF Pulse Repetition Frequency scale in PW by the PW PRF rocker switch situated next to the PW knob Upwards activation increases the PRF downwards activation decreases the PRF The updated PRF value in KHz is displayed at the right of the screen and the PRF scale on the spectral illustration is updated 9 6 Steering Key number 11 The PW gate line can be steered by the rocker switch Steering Upwards activation steers to the left downwards activation steers to the right Automatic steering is available together with automatic angle correction see chapter 9 7 1 Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 41 sur 173 BECM Noveko NB Steering is only possible when using the linear probe 9 7 Angle Key number 12 Activation and adjustment of the angle correction in the PW gate by the Angle rocker switch The system converts the Doppler frequency shift in velocity Always place the Angle in the same direction as the flow Upwards activation tips the angle to the right downwards activation tips the angle to the left The speed scale in cm s or in m s is updated to the right of the PW spectrum The angle value is displayed at the right of the screen When the angle correction is activated the key Angle in the conte
198. xit of the Presets 34 Setting Access to the menu of general settings of the device Exit of the menu 5 4 Exit of Settings Patient Report User protocols and Annotations 35 Clear Export Import Archive Consult reports User short key Multiview Exit from a loaded image or sequence Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 24 sur 173 BECM Noveko 5 2 Screen Shut down of the device Orientation indicator Date time Power parameters Probe Preset Application Parameters of theimaging modes lt 4 Foc Increments Be of 1 cm 4 Depth Probe indicators Highlighted probe is active menu Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 25 sur 173 BECM Noveko 5 3 Contextual menus Each of the following modes and functions activate a contextual menu according to the used mode B M CFM PW CW B CFM PW 4D Freeze Review Measures Protocol Preset The contextual menu is displayed on the bottom of the screen It is composed of 5x2 keys The contextual menu is controlled with the contextual keys Keys number 25 or by placing the curser on the menu and clicking Select with the Select key The contextual menus can have from one to several levels according to the used mode To go from one level to the next press the key Next either with the contextual keys or with the trackball and Select To retur
199. xtual PW menu is highlighted in red The angle is displayed as a line in the PW gate If the automatic angle correction see chapter 9 7 1 is active the angle will be displayed as a line and two small spots on each side of the line Deactivation of the angle correction by pressing the key Angle in the contextual PW menu 9 7 1 Automatic Angle correction The angle correction can also be activated by the key Angle in the contextual PW menu When the angle correction is activated the key Angle in the contextual PW menu is highlighted in red If the circle None in the Setting page see chapter 5 4 is ticked the angle correction in the contextual menu is manual and identical to the Angle Rocker Switch If the circle Angle in the Setting page see chapter 5 4 is ticked the angle correction in the contextual menu is automatic but independent of the steering of the PW line The device will optimize the angle correction according to the flow If the circle Angle and Steering in the Setting page see chapter 5 4 is ticked the angle correction in the contextual menu and the steering of the PW are automatic The device will optimize both according to the flow If the automatic angle correction is active the angle will be displayed as a line and two small spots on each side of the line in the PW gate Otherwise the angle is displayed just as a line If the box PW angle on start is ticked the automatic angle correction will be active when turning
200. xtual menu See chapter 15 1 7 15 3 9 Print See chapter 15 1 8 15 3 10 Delete Contextual menu See chapter 15 1 9 Exit of the Measure mode and return to Freeze mode by pressing the key Measure Exit of the Measure mode and return to live imaging by pressing the key Freeze Version 3 du 16 07 2012 R f CD MA Manuel utilisateur Imagyne 2 02 EN v3 Page 59 sur 173 BECM Noveko 15 4 Measures in CW 15 4 1 Time Contextual menu Click on the key Time to measure the time on the CW specter The curser is trapped by the first marker Place the first marker at the wanted place with the trackball Validation of the position by the Select button left or right Place the second marker with the trackball at the wanted place Click on the right Select button to pass from one marker to another in order to adjust the time measurement The active marker is white Click on the left Select button to validate The result of the time measurement is displayed in seconds at the bottom left corner of the screen 15 4 2 Speed Contextual menu Click on the key Speed in the contextual menu The curser is trapped by the marker Place the marker on the CW specter at the wanted place and click Select left or right The result of the speed measurement is displayed in cm per seconds at the bottom left corner of the screen 15 4 3 Acceleration Contextual menu Click on the key Acceleration to activate the measurement The curser is trapped by the first m
201. ze Click on the B Knob to exit the 4D pre menu and return to B imaging 12 1 1 Sweeping contextual menu Adjustment of the angle of the probe s movements Increase of the angle by pressing Sweeping decrease of the angle by pressing Sweeping 3 angle steps 12 1 2 4D Field of View contextual menu Adjustment of the acquisition volume Increase of the size by pressing 4D FOV decrease of the size by pressing 4D FOV 12 1 3 Dynamic contextual menu See chapter 6 7 in the user manual on adjustment of the dynamic scale 12 1 4 Gamma contextual menu See chapter 6 17 in the user manual on adjustment of the gamma curve 12 1 5 Acquisition Speed contextual menu Selection of the acquisition speed Fast or Slow The active speed is highlighted in red 12 2 4D After adjustment of the above listed parameters press the key 4D key number 28 once again The probe starts to move The 4D volume image is displayed in the middle of the screen In the upper left of the screen a randomly refreshed B image is displayed with indication of the position of the 4D box The height of the 4D box clipping can be adjusted by clicking on the upper or the lower line of the box The line gets blue and can be dragged with the trackball Click Select right to switch between the upper and the lower line Click Select left to validate the new size Display of the 4D live contextual menu 3 levels 12 2 1 Gain Key number 4 Adjustment of the B and 4D

USER MANUAL Version 2.02

Contents

Download Pdf Manuals

Related Search

Related Contents