electrical impedance computer mammograph meik ® 5.6
Contents
1. eeeeeseeess 37 High Risk Group Formation 38 Usage of Age Related Electrical Conductivity Scale 38 Usage of Divergence between Electrical Conductivity Distribution HON IN 40 ENN 40 1 Introduction MEIK 5 0 with software version 5 6 calculates relative electrical conductivity of tissues which is the assessment criterion for physiological and pathologic processes in the mammary gland such as cancer fibrocystic disease mastitis physiological involution lactation etc 1 1 Device unpacking MEIK 5 0 is supplied to the customer only after completion of all preparatory works tested and in fully equipped When the device arrives unpack it immediately and check for any damage that may have occurred during transportation Check the package contents with the enclosed Packing List If any defect fault or deficiency is found during the acceptance inspection notify your dealer sales representative of the details immediately 1 2 Safety Signs Refer to user manual booklet o General safety sign General prohibitory sign General warning sign Laser hazard Q A 1 3 Device features Mode selection function screening or diagnostics Seven scan planes within the range from 0 4 cm to 4 6 cm Visual evaluation of the image with the help of proper estimation procedure Quantitative evaluation mean electrical conductivity index and the histogram of2. Archive ARCHIVE button enables to change the current archive or database Press BROWSE to locate and load an archive then click OK button Pressing and holding Ctrl button enables to change the NORM database the title bar will change to Norm selection Selection of archive Measurement Click MEASUREMENT button to proceed to mammary gland scanning The following scanning conditions are to be set before the scanning patient s position and side of scanning right or left physiological period specifying either the day of the menstrual cycle or the length of the menopause both are counted automatically after entering the date of the last menses the duration of gestation or the day and month of lactation If necessary click in the right upper corner to select the segment of the gland to be scanned Measurements conditions Information INFORMATION button enables to obtain information about any series of measurements the file name of the given scanning series the code number the patient s name and age examination date and comments Information Measurement conditions File name Last menses i Phase 1 4 Cage Phase 2 30 days Name Zabelkina O Postmenopause Age gt Pregnancy Measurem date j Araton Births left laying 2 phase 30 days Position Side Segment Editing EDIT button enables to edit patient s personal data code number name and date o
3. images and measurement results for any pathology or norm Image copy feature to any storage medium Sending images via e mail feature Selected norm validation feature evaluation of the selected reference norm according to Statistical criteria to enhance diagnostics HER e e Fe e 6 F F E FEF When selecting a computer for use with MEIK please follow the requirements listed Q below in order to fully benefit from all the functions of the device and to get high operating characteristics e Intel Pentium IV or higher processor or compatible e Atleast 1 GB of system memory RAM e Atleast 500 MB available hard disk space e Atleast 1024x768 flat LCD full screen colour monitor e Available USB port e Video adapter with 3D hardware graphics acceleration with at least 128 MB memory e Supported operating systems Windows XP Service Pack 2 Windows Vista Windows 7 e Atleast 120 GB external hard disk drive for data backup is highly recommended To avoid mutual interference do not position MEIK close to high power devices e g power lines as this may adversely affect the quality of visualization 2 Device operation This chapter is focused on the essential information on the patient preparation for examination and the directions on how to conduct the examination procedure correctly C Please before operating the device carefully read this entire Manual 2 1 PRODUCT SETUP N Before ope
4. 317 Far mmj Mean 825 BLS 0 12 Min amp Man NE Esau 0 14 Di diser 3 66 Man Nel RHS 0 11 Min 4 01 Mar 0 10 Ext etm BIF ES kr muti Mean 4 77 BUMS DT 0 13 Min 6 05 Max NET Extrem 077 Dist discr amp 198 CETTE 0 31 RLS 0 11 Min 2 01 Man ET Ext emm am RUE P mm Mean 92 21 LR A 0 14 Min 6 06 Max ET Extremum 6 11 Dist discr 8 208 Mean 0 12 FHS 0 17 Min 2 Max Eo Erin 211 Hr jt uri j I FINT Data transfer field has four buttons and provides various ways of data transfer Report Click REPORT button to draw up an examination report and a medical conclusion The procedure can be performed in manual or in automated mode CANCEL Manual report Choosing MANUAL MODE will display the table of the last report on the screen It Shall be filled in by the user Organization Phase 1 Phase 7 Earthy repaaducthee period The most frequent diagnoses are specified in the LIST OF DIAGNOSES Highlight them and press ADD button to move them to the CONCLUSION line Age norm Focal conductivity changes typical for noncomplicated disease of mammary gland Focal conductivity changes typical for the complicated disease of mammary gland Focal conductivity changes typical for non malignant growth cysts Focal conductivity changes typica
5. 35 Extremum 0 24 Position Mi Max 0 57 R M S D 0 11 Phase Layer 4 Min 0 13 Mean 0 33 Extremum 0 00 Selection 18 Max 0 55 R M 5 D 0 11 Layer Min 0 13 Mean 0 31 Extremum 0 00 Max 0 55 R M 5 D 0 12 Layer 6 Min 0 14 Mean 0 30 Extremum 0 34 Max 0 57 R M 5 D 0 12 L ayer 7 Min 0 15 Mean 0 31 Extremum 0 00 Max 0 60 R M 5 D 0 12 The histogram of electric conductivity distribution for the NORM will be added to the patient s histogram Below the histograms there are statistical parameters of the patient s mammary gland electric conductivity and these for the NORM the index of mean electric conductivity the standard deviation STD electric conductivity index minimum and maximum and the extremum mode The last line contains the ratio in 96 of divergence between the patient s histogram of electric conductivity distribution and the histogram for the NORM the ratio being calculated by the Smirnov Kolmogorov criterion This action applies only to the histograms of current measurement um SL Gt imi AN mil 8 1 ell GF AMS 613 din 0 14 in EE im 0 15 im OF din 0 57 Bax Bn a a3 DAE ax 0 5 Haz 0 53 i viri 0 14 where 0 90 tiem 0 9 E pirra D re mum 0 00 blaan E um FA Win 1 06 ax 1 1 Letramum 0 00 Lxtremaum 0 00 riremum 0 3 L remum 0A Leinemum 0 60 Hae UELLE Har discret S65 har dior 6 61
6. default in the program FLOATING ONCO MARKER setting enables to search for and to highlight the areas of high electric conductivity typical of cancer on all the scan planes taking into account mean electric conductivity on each scan plane The mode selected is saved by default for further operations Fl Highlight the areal Contrast CONTRAST button enables to change the contrast ratio of the image There are several presets helping to diagnose a number of diseases cysts cancer and infiltration The INVERTING SCALE setting transforms positive images into negative which facilitates image analysis To change the image contrast ratio move the left or the right slider until the required value is reached and click OK button Press RESTORE button to restore the original values Set contrast value o Mdh Colour Scale COLOUR SCALE button enables to display the images in colour Blue colour corresponds to minimum values of electric conductivity while red colour indicates maximum values Press GREY SCALE button to restore the original values m i s 16 he L Date 16 03 7007 13 34 Comment right laging 7 phase W dapi E x E r P ir Parameters PARAMETERS button allows to display contrast ratio and the selected range values set up by the user as well as to show grey or colour scale of electric conductivity Conductivity Scale X 0 0 0 5 Contrast left value 0 00
7. electrical conductivity distribution Function of contrastive image analysis qualitative and quantitative evaluation of the obtained images Function of phase image analysis qualitative and quantitative evaluation of the obtained images during the different phases of the menstrual cycle 3 D three dimensional image creating and viewing of 3 D images of the mammary gland saving option image or video Cancer markers quantitative evaluation helping to diagnose early nonpalpable stages and qualitative criteria to diagnose palpable malignant tumors of the mammary gland Non cancer markers quantitative and qualitative criteria facilitating diagnostics of palpable benign tumors of the mammary gland Nonparametric diagnostic criteria quantitative evaluation enabling to diagnose nonneoplastic diseases of the mammary gland Multiwindow mode feature of simultaneous viewing and comparison of several images of a patient s mammary gland Making of the examination report in manual or automatic mode feature of automatic creation of the report with the help of embedded diagnostic algorithm Feature of automatic screening report creation with the use of preset criteria Feature of adding to the system images acquired with the help of other diagnostic methods ultrasound X ray etc adding and saving the images for further integrated assessment of the pathology Archive creation feature images measurement organizing a database containing
8. from LIST seven images of the mammary gland appear in the image field The images correspond to the scan planes set parallel to the electrodes plane the depth increasing from 4 to 46 mm The upper line contains the patient s code and the numbers of scan planes with the correspondent depth measured in mm Each line of the image field contains 7 images the number of lines is unlimited The line above the images has a caption with the information on the given measurement series date and time of examination comments on the conditions of examination The column to the left of the first scan plane images has a number of icons intended for various operations with the images listed from top downward 3D zoom contrast highlighting colour scale scale capacity and histograms The icons are active for the selected line of images only BE Turni BM mmi EJE mmi TNN NAN NE wr NL k du Tir Tr COMPOUND Moan Moan amp Mean Meron HISTOGRAM BAS 0 11 RLS 0 12 RLS 0 12 BBLS 0 11 3 1 5 T 0 11 RLS 0 11 RBLS 0 12 Min 4 07 Min 4 31 Min ib 1E Min oh i 8 17 Min i Min P Max 0 65 Max ET Max 6 41 Maz 6 41 f 2 47 Max A Max 5 3E Esmin 8 25 Exttamum 8 2 Eaim NL Er uu A Ext enum 6 08 Ears 1 Faren 0 00 3 D image The E icon allows for getting the visualization of electric conductivity volume distribution within the mammary gland tissues On default the image is 64 colour In 3D i
9. function of this icon is similar to that of HIGHLIGHT button in the qualitative analysis field MHighlight the areal Colour Scale Click Cp to display the images in colour Click a to restore the original image grey scale The function of this icon is similar to that of the COLOUR SCALE button in the qualitative analysis field F n mill k de Date 16 03 3007 13 34 Comment right legirg 7 phase 00 days ql 1 F P i cud 7 1h i 4 i Scale Capacity Click 16 Or to choose the scale with 16 32 or 64 colour gradations respectively for operations with the images Histograms Click icon to display the histogram of electric conductivity volume distribution within the mammary gland tissues fara 1605 F007 15 31 Koumsektaprt Nea fee 7 chee 30 A pr Y d h d Cpeguee 0 35 j Cpeniee 5 25 E fie DIT CK RA DRG bd CA 0123 CRD 06 12 Man 0 i Mun 8 4 dun O06 Man E i Mare 0 87 Mast 61h pee E Mare E Seppe 0 E OSEE See hppa 0 15 Seppo 0 13 Below the histograms there is statistical information on each scan plane the index of mean electric conductivity the standard deviation STD electric conductivity index minimum and maximum and the extremum mode Click BM to restore the original values is displayed after clicking COMPOUND HISTOGRAM in the quantitative analysis field It enables to compare the histograms of electrical conductivit
10. har dier ET LUoUUTELOT Har disor dt 957 Tomogram Comparison TOMOGRAM COMPARISON button enables to compare the histograms against each other The tomograms for comparison can be chosen by clicking the left button of the mouse The selection of the tomograms and histograms of electric conductivity distribution in the mammary glands intended for comparison will be displayed in a separate window Click PRINT button to print the images and histograms Date 16 00 J007 13 41 Commenciel laying 4 phais 50 days 1 4 mun Ari uu 3 18 mm AS mm E Sle mm FE 719 mm ETS mm T s Allocation of the hivognam 1 X 0 8 122 Y 0 0 12 2 12 2 12 2 am Allecation of the histogram 2 X 0 8 12 2 Y 0 0 12 2 122 12 7 am LMectuicnenrn I Hearn DAT Mean RT Mean 9 74 LM S50 p RHSD 0 14 RELS 60 93 Win 0 00 Min 6 Min p Wax 0 59 Marx 0 57 Mayr pEi Erramum 0 43 I uic RE Rh Esmin 0 37 Mat disp 5 27308 m No XL Da Ma TIN BG baal Haan 0AT Wtan E T Maan MR ALSO 611 RESE ois RSD 0 17 Win 0 14 Min 6 01 Min 04 Hax NAT Man En Man Enn Ertami 0 45 Exim G4 Extr snim 835 Date 16 03 J00T 134 Cammanerigiha Laying 7 phase 20 day ee mim Bit omen IE bb mim CT IET Data Transfer Field Mean 0 30 BULBS 0 17 Min 6 07 Max NI Emi 34 Dist diser 4 00 Mean 0 52 RHS 0 11 Min E H Man 4 51 Extr sririm 0
11. patient s arm nearest to the breast under examination shall be placed behind her neck The nipple shall be centred 2 2 3 Moistening The mammary gland shall be moistened with water water drops shall be avoided 2 2 4 Gel electrodes application Apply disposable hydrogel electrodes to the forearm of an opposite arm or put the cylindrical electrode to the opposite hand of the patient Mind that the arm should not be touching the patient s body eo ECG electrodes SKINTACT F 55 or MEDI TRACE or 1700 CLEARTRACE are recommended to be used as disposable gel electrodes A Do not reuse the electrodes Do not use dried electrodes or electrodes past their expiration date A Do not apply excessive force when disconnecting disposable electrodes from push button latches to avoid cable breaking Measurements Specify measurement conditions Measurements conditions aay Bc Tw l i r 1 ril ME E pam E 4 E 3 T P After pressing Start button on the device or in Measurement conditions dialog box the device switches into the standby mode that is indicated with flashing yellow LED Laser marker in the centre of electrodes array is activated In the image field there is displayed an oval with red dots corresponding to the number of electrodes of the electrode array Waiting Poor contacts 256 100 The device features a low power laser pointer with adva
12. right value 1 00 Highlighting not set Quantitative Analysis Block Quantitative analysis field has four buttons and provides numerical information Compound Histogram The COMPOUND HISTOGRAM button enables to preprocess the histogram converting a simple histogram into an enveloping one for its further use in the compound histogram e g to compare it with the norm or another histogram This action applies to the images of all series simultaneously r n ru ji Comment lef laying I UBL NOOO y titan 0 15 dean 0 35 HASJ 901 MLS ola Hin er Win 1 14 in 0 16 din 0 15 Win D ax 0 01 as 0 60 aa Oy Was 0 48 Max 0 535 Leiemum 0 Hean Na HES e Win 01 52 blar OFT B uiri 0 0 Lxiremaum 0 13 O14 H Y T pi Bim 0 14 Maw 0 6 Lixctremamm 0 13 Extremum 07 Mean i p am Han n 45 ban hag Extrema 0 10 Extreme QU Lxiremum 050 LEN K 014 Min 4 22 Mak E Ewireanum 015 Graph Type GRAPH TYPE button enables to modify the histogram envelop and display it as a smoothed representation of electric conductivity values GRAPH TYPE 1 as well as its unsmoothed values GRAPH TYPE 2 This action applies to the images of all series simultaneously D000008 1 14 kann 0 12 mi E Wegen GM ELE ii Y T E A ART ER AE TIT EF ti SJ O42 Wi 0 16 dan TT kar an Er Evire 0 13 Lxtremasm 0
13. 10 ILI AL mr Bla T m Fo Date 6 07 3007 12 31 Comment loll lapie I phase 0 days Becr wow ean 0 14 ran 0 12 Tm Y AAS bd hi SD 6 93 il S 0 0 12 piisi EF T i in 1 14 din 1 16 Him 0 14 T MLB UN tin 4 idan 0 60 aa QA Ma Bl Lxtremam 0 13 Lxiremaam 0 10 Extreme 2100 B uiri 0 0 7 em 0G DE Late F 15 Comparison with Norm The COMPARISON WITH NORM button enables to compare the patient s histogram of electric conductivity distribution with the NORM histogram thereof Conditions for creating the NORM histogram are to be selected before the comparison can be started The right hand column contains the patient s personal data In the left hand column conditions of the normal histogram shall be ticked The number of tomograms satisfying the conditions for histogram selection with characteristics of the NORM which are intended to be used for making up the compound histogram of electric conductivity distribution typical for the NORM is shown in the SELECT line The total number of tomograms available in the NORM database is shown above that line Click OK button to confirm the selection Conditions of norm creation Chosen norm statistics Patient Layer 1 Min 0 31 Mean 0 47 Extremum 0 39 Max 0 64 R M 5 D 0 09 Layer 2 Spring 29 years No Min 0 18 Mean 0 38 Extremum 0 26 Max 0 58 R M 5 D 0 10 Layer 3 Laying Min 0 15 Mean 0
14. 5 Diagnostics Mode 15 Control Buttons Field rore Erg a Yoon ERE e tSt ve Ever RR vs 15 Information BIOCK oor 16 HE 16 SE EEE ETE RANEREN RAT VEE RT DEUDA 16 NEW PN 17 Patient Sv 18 NVE 20 Men 20 E 21 FANNE 21 Qualitative Analysis Block srrrrnnrornnnnnrrnnnnnrrnnnnrrnnnnerrrnnnnrnnnnnernnnnerennn 22 One Window Mode urnen ipisteaeatousin 22 FAVS PAU csse 23 CONAS saws eT 23 COlOUF Scale NNN 24 PIT 24 Quantitative Analysis Block rrrrrnrornrnnrrrrnnnrrrnnnnrrnnnnernrnnnrrrrnnsernnnnenennn 24 Compound HISTOR N av 25 EN EEE 25 Comparison e mre ub aeu Head es Hs 26 Tomogram CompS scene n pra EN SERES USC xvn x RE E Es NU SES To es 27 Information Transmission Block 27 REDONE EEE 27 MEINE 28 Automatic 29 miguel 30 ENN 30 Adad TO NOM af 31 Close the SESSION se 31 ENC AEE 31 mares Fe M 31 SDI NE 32 FUNN er eno ea Ree ORR MEUM NI UD eee 33 CONAS E sas RE 33 Hehenin x ossia iuc dete no aho 33 COOUR SA ve 34 SC Ale CAD ea EE EE EE EE 34 se SN ET 34 MATT 35 Additional Window sees eene 35 Screening MOde 36 Special Features in Contrast to Diagnostics Mode 36 Examination RENT 36 DETIMITION OF Screening 37 Dig BOSC Criteria 37 Early Diagnostics of Breast Cancelr cccccsssecccsseeeeceeeceeeeeseeeees 37 Usage of Electrical Conductivity Index
15. 7 Mihailyuk VV 1254387049 tdb 137 Mihailyuk VV 1254387157 tdb Age scale 137 Mihailyuk VV 1254387902 tdb 137 Mihailyuk VV 1254388040 tdb 55 Belkova VV 1240387915 tdh 67 Zapilova VA 1241774522 tdh 67 Zapilova V A Destination folder selection The selected patients are listed in the right hand window Double click patient s surname to load any patient s mammogram in the image field Tate 16035007 12 31 Comment bef loging 7 phase 1 down ean 0 15 ean 0 35 tearm 01 17 dean 0 58 ean 0 61 ran Ft HLS 913 HEM SL H dE SC HMSO 407 nhl BMG HMSO 6 um ORO Hin 0 in 0 14 in 1 16 Win 0 15 m bin gt 0 87 Win 0 27 Wax 1 1 bla 060 Wax DAG Hax 0 51 Bas 0 45 Liiremum 9 21 Lxiremaum 0 13 Leiremum 0 10 Extremum 0 02 Leremum 0 00 Leiremum 0 00 The list of the selected patients can be copied to any storage medium or printed Usage of Divergence between Electrical Conductivity Distribution Histograms The indices showing the anomalous divergence in the histograms of the electrical conductivity distribution between the left and right breast are also used to form high risk groups The variance percent chosen with the help of the Kolmogorov Smirnov nonparametric test more than 40 is highly informative j gt 3 0 according to Kullback This function employed the program makes selection of the patients with the
16. ELECTRICAL IMPEDANCE COMPUTER MAMMOGRAPH MEIK 5 6 USER MANUAL CE 1023 PKF Modern Impedance Medical Equipment www impedance ru All rights reserved No part of this document may be copied reproduced or distributed in any form without express written permission from PKF SIM technika PERMITS AND REGULATORY DOCUMENTS PKF SIM technika Ltd possesses medical equipment manufacturing licence Registration Number 99 03 002246 December 9 2010 with appendices Electrical impedance computer mammograph MEIK 5 0 for mammary gland screening by means of electrical conductivity distribution pattern visualization with software version 5 6 hereinafter referred to as MEIK9 5 0 is granted with the registration certificate 29 050010303 5420 03 dated July 3 2003 and the Declaration of Conformity Ne POCC RU UMO02 100518 dated September 26 2012 The safety of MEIK 5 0 with software version 5 6 was certified according to Council Directive 93 42 EEC MDD by ITC Czech Republic MEIK was awarded with the European certificate CE 1023 with the right to affix the CE marking right at the production Quality Management System implemented by OOO PKF SIM technika is certified by DOS Germany and conforms to the requirements of ISO 9001 2008 EN ISO 13485 2003 AC 2009 MEIK9 software version 5 6 is officially registered in the Russian Federation with Registration Certificate 2009611472 Trademarks and logos of SIM Technika and MEIK offici
17. Measurement Duration Measurement duration is about 35 seconds Image Reconstruction Reconstruction Method Selection After the measurement is completed please select the method of image reconstruction When the message appears on the screen the mammograph may be removed from the breast Choose a way of reconstruction of the image Reconstruction Duration Reconstruction process duration is about 1 minute and depends on PC characteristics Image Reconstruction m 18 ABORT Adding Comments After the reconstruction is completed the comments window appears together with seven scan planes in the image field Ban 18 01 2007 1131 Comment bh laying 2 phase H day NN NE NE NE N og Fm FI s 3 MEIK SOFTWARE OPERATION VERSION 5 6 This chapter considers all program controls in diagnostics and screening mode The operating mode can be selected according to the purposes of the current examination 3 1 Diagnostics Mode This chapter introduces the controls of Diagnostic Mode The information on such features as image processing quantitative analysis database creation copying and sending examination results is provided Control Buttons Field Control buttons are arranged into several groups depending on functional features information field qualitative analysis field quantitative analysis field and data transfer field Information Block The information field consists of eig
18. ally registered in the Russian Federation and are the property of OOO PKF SIM technika Ltd MEIK 5 0 is manufactured according to TU 9442 001 18100676 2003 as amended MEIK 5 0 is protected by Eurasian patent for the invention 012 006 with the priority right from July 5 2007 i All references to trade names of other companies within this User Manual are provided for their identification solely without any infringement of their rights and shall not be considered as a commercial or an advertisement Table of Contents Introduction 5 Product Features 4 5 Product operation Pua O How to Prepare the Device for Operation 8 Gade 8 CONNECTION OPL ue adea mU eem wIdi c Sesso Masi a E 8 Patient sData NS 9 Patients rd Film 2 9 MeasirementS SN 10 P tient sPreparations arver 11 Patient SPONSE 11 Breast Pole 11 8 11 Remote Be re a hama Da rae odd Sr 11 Electrodes Panel FA NON arve 11 NOE t ES 12 Mammary Gland Examination ccccccsssecccesececeseeeeeseceseueceseeeeeees 13 Beginning MeaSureMe n cccccssccesccesccesccesccesecasessecesseeeeeees 13 Last IMegsubremefitesuies enue iier Sedo Cu Hune iis 13 Measurement DuEablorizcde ro 13 image ReconstrietloD uce ce 14 Reconstruction Method Selection 14 Reconstruction DU gtilOfi c 14 Adding COMM CIS eere eter mediae or Ere Tet be duo eb xeqn 14 Software Operation 1
19. anomalous divergence in electrical conductivity distribution histograms between left and right breast more than 40 from the current database base address can be found in the top line of the window All Selection 4 1010 Morozova VM 1155970166 tdb 1010 Morozova VM 1155970249 tdb 1010 Morozova VM 1155970331 tdb 1010 Morozova V M 1155970416 tdb 1010 Morozova V M 1155970516 tdb 1010 Morozova V M 1155970604 tdb 1010 Morozova V M 1155970695 tdb 1010 Morozova V M 1155970785 tdb 1010 Morozova V M 1155970901 tdb 1010 Morozova V M 1155970970 tdb 1010 Morozova V M 1155971041 tdb 223 1010 Morozova VM 1155971115 tdb Distrib discrep between left and EE 1010 Morozova V M ICIIATI IIEHATIb Destination folder selection Le ITI rane disi The selected patients are listed in the right hand window Double click patient s surname to load any patient s mammogram in the image field The list of the selected patients can be copied to any storage medium or printed Copying To copy the mammograms of a patient click COPY button To copy all the mammograms of the current database click BASE button On default files are copied to a new folder but any folder can be selected to store the files with the help of BROWSE button The data can be copied to any storage medium or can be sent via e mail Ending operation Before logging off from current session please e ensure that acquired data hav
20. e been saved e print out examination reports Then e close program e shut down the computer turn surge protector off e disinfect the device and its base in accordance with the recommendations see p 9 e close the package with gel electrodes firmly 4 CALIBRATION Primary calibration of the product is performed at the release of the device from the production line Recommended interval for periodic calibration is 24 months It is carried out at the request of the consumer at the production environment 5 TROUBLESHOOTING MEIK 5 0 is a high precision electronic instrument assembled using modern assembly equipment at the production area of OOO PKF SIM technika Ltd by highly qualified personnel Any failures caused during transportation operation or unforeseen circumstances should be repaired only by the manufacturer at the production area after comprehensive testing and subsequent acceptance tests Possible cause Possible solution The emergence of yellow 1 No contact between the spring 1 Return to OOO PKF SIM contact dots in fixed locations loaded electrodes and the technika Ltd for factory repair on the green contact field multiplexer board inside the device 2 Clean the electrodes and which do not disappear when 2 Contact electrodes and device device bottom with ethyl alcohol the device is reapplied to the bottom greasing or with the cleaning fluids mammary gland recommended by the manufacturer Du
21. ean conductivity index Distrib discrep between left and right Histogram shift Distrib discrep between the gland and norm Histogram shift Local changes of conductivity Size Print Press PRINT button to print selected images Click left mouse button on the image to select it The flashing caption will be displayed in the right upper corner of the screen showing the position of the image on the page e g Page 1 Figure 1 Page 1 Fig 1 Page 1 Fig 2 Page 2 Fig 1 Copying COPYING button enables to select necessary images and measurements to sort them in corresponding folders CANCEL The measurements are copied into the file compatible with Microsoft Excel Either a single current measurement or a series of measurements can be copied On default files can be copied to various folders but any folder containing diagnoses of interest can be selected to store the files with the help of BROWSE button The data can be copied to any storage medium or can be sent via e mail Image for copying Add to Norm ADD TO NORM button enables to renew NORM database Either a single measurement or a series of measurements can be copied can be added to NORM Measurement for addition to norm O Current All Close Session CLOSE SESSION button serves for clearing image field Exit Press EXIT to quit the current mode of operation Images Field Upon the scanning procedure or the selection of patients
22. ent scan plane Date 16 03 2007 13 31 Layer 1 12 0 0 Cursor X 0 0 sm Y 4 4 sm G 0 06 Hist X 2 0 9 5 Y 2 4 10 2 7 5 7 8 sm Mean 0 29 R M S D 0 13 Min 0 02 Max 0 77 Extremum 0 24 3 2 Screening Mode In this chapter all the controls used in the Screening Mode are observed Early diagnostics of breast cancer findings and high risk group formation data are provided Special Features in Contrast to Diagnostics Mode Software operation in Screening Mode is similar to that in Diagnostics Mode the only difference is in limited functionality and The main difference lies in limited functionality and in Examination Report feature Report Click REPORT button to see the window with two information fields The left information field represents diagnostic criteria unit and data copy unit The right field represents current database information Archive Patients Measurem All Selection Destination folder selection Imi Definition of Screening World Health Organization defines screening as the presumptive identification of unrecognized disease or defects by means of tests examinations or other procedures that can be applied rapidly and for the large population groups Screening examination enables to form the groups of people at risk for development of certain decease A high risk cancer group should be defined as the group of people in the community with symptoms of the so called pre existing d
23. f birth Patient s data He ru gr a P t T Code EE Recent code FINE l ar el ee 1 C ut urbi LEA d 7 J Zabelkina 0 Qualitative Analysis Block The qualitative analysis field has five buttons and is used to process the images of all examination series simultaneously Single window Mode Press SINGLE WINDOW MODE to display a series of measurements of the patient s mammary gland executed under certain conditions date physiological period etc Press SINGLE WINDOW MODE button again to go into MULTI WINDOW MODE which allows to add several windows with other measurements to the current measurement window to make comparison and subsequent calculations more convenient For instance the mammograms obtained during the first phase of the menstrual cycle can be complemented with the mammograms of the second phase In this case new measurements will be highlighted with colour 4 8 M il FI FI FI EF eo ocw AF A Fi E wv Xr r FI FI Cede 85 7 Date 15 00 7007 13 38 Comment right laying 7 phase 30 days f Highlighting HIGHLIGHTING button enables to highlight the areas with certain electric conductivity Dar Ti 007 12 91 Comment heh laying 7 phase 10 days OG Jr Ne NE NV d FI A Ar The minimal lower and the maximal upper range values are to be entered The selected range is saved by default for further operations The electric conductivity range typical of cancer is set by
24. ht buttons and contains information about the patients List Click LIST button to see the list of patients from current database in code ascending order A tooltip with information about the measurement appears when pointing any item of the list with the mouse cursor in all dialog boxes If the code of a patient under consideration is found in the list highlighted with blue colour the tomograms of the breast can be loaded in the image field by double clicking the mouse button on the selected code or by clicking ACCEPT button Patient selection Search Click SEARCH button to search for a patient in a current database or in any other database if you change the achieve by name patient code or date of examination Patient Search Patient El Al rn ive New Patient Press NEW button to register a new patient Enter the patient code name and date of birth The number of the last patient code in the current database will be displayed in the right screen corner Patient s data Medical Record Press MEDICAL RECORD button to see the medical record of a patient It includes personal data complaints and anamnesis recent breast diseases and information about previous examinations Personal data Personal data Complaints EEE Complaints Anamnesis Anamnesis DEVIATIONS Diseases of the Breast Diseases Examinations Fxaminations Palpation R It
25. isease which can be detected due to various reasons The pre existing disease concept is of special importance in connection with the given opportunity to actively conduct cancer prevention measures already on such an early stage Screening is a dynamic process And in this connection the usage of safe screening methods makes sense because it enables to conduct multiple repeated examinations Electrical impedance mammography is just the sort of method which can be repeatedly used to examine a patient Diagnostic Criteria Unit Diagnostic criteria unit consists of the following early diagnostics with the help of electrical conductivity index high risk group formation with the help of the age related electrical conductivity scale and anomalous divergence between electrical conductivity distribution histograms of left and right mammary gland Early Diagnostics of Breast Cancer Breast cancer can be diagnosed at an early stage owing to the usage of the electrical conductivity index Usage of Electrical Conductivity Index If the method of diagnostics under examination permits to acquire a numerical result the so called breaking point the value exceeding of which is considered as a sufficient cause for qualitative assessment should be determined In this case the estimation of diagnostic technique efficiency may be limited to sensitivity and specificity assessment Thus the accurate determination of the breaking point is extremely im
26. l for infiltrative mastitis Focal conductivity changes typical for intramammary abscess Conductivity changes typical for infiltrative edematous forms of mammary gland disease Conductivity changes typical for hormonal form of mastopathy Conductivity changes typical for fibrous form of mastopathy Conductivity changes typical for mixed form of mastopathy Fibrous hyperplasia Stromal hyperplasia Bilaterial sinusectasia Left side sinusectasia Right side sinusectasia Press ATTACH button to attach the data obtained with the help of other diagnostic methods ultrasonography X ray examination to the report The following data can be attached images videos in any format or images acquired from the scanner connected to the computer OQ Ultrasound Attached data are marked by a paper clip on the image field Press the corresponding hotkeys to save or print the final version of the report Automated Report When AUTOMATIC MODE of reporting is selected only the image and measurement analysis shall be done Diagnostics is based on the expert system Image visual evaluation Left gland Right gland 1 Deformation of Ono yes 10 yes mammary gland contour No palpable mass located After answering the questions of image and measurement assessment the conclusion is created by the software which can be saved and printed as in manual mode Measurements second plane Left gland Right gland M
27. mage mode the following icons in the vertical column located to the left of the images of the first scan plane are clickable contrast area selection colour scale gradation scale Image controls are in the bottom part of the screen The controls on the left enable to move the image as well as to zoom it in and out The image can be moved with the help of the left mouse button hold down your left mouse button and drag the image in the direction you wish it to move You can also zoom the image in and out The SHOW LAYER function enables to add or remove scan planes layers of interest The 3D image can be printed and or saved in any format The creation of the video movie is necessary to preserve the electrical conductivity of the object during its movement If saved data are available the 30 icon in the image field is green Click the icon to see the menu for saved data review or 3D image creation Enlargement Click E to zoom the image Poor contact areas discovered in the image are highlighted yellow Click to return the image to its normal size Contrast Click to change the contrast ratio of the image The function of this icon is similar to that of CONTRAST button in the qualitative analysis field The change of the contrast ratio is immediately reflected in the current line of images Set contrast value O Manually Highlighting Click to highlight the areas with certain values of electric conductivity The
28. nced Q Avoid looking into the laser beam Do not point it into the eyes of the patient and onto reflective surfaces Electrodes array positioning avoid hurting patient Note The electrodes array is placed against the breast in such a way that the laser marker is positioned on the nipple It is necessary to achieve the minimal number of poor contacts good contacts are displayed as green dots on the screen Waiting Poor contacts 0 0 A Do not apply excessive force when positioning electrodes array at the breast to If the mammary gland is not completely covered by the panel the examination must be carried out by segments clockwise upper external lower internal segment of the mammary gland In order to obtain correct position of the image in the screen from top to bottom corresponding the direction from head to legs please position the device in such a way that the side with the connectors was aimed at the feet of the patient Mammary Gland Examination Beginning Measurement Press START button on the screen or on the device to begin the measurement The yellow LED indicates that that the measurement is in progress during all the process of scanning The laser marker switches off automatically when the measurement begins ak Recent Measurements In the upper left corner of the image field there are displayed the last three images of the gland in the current session
29. orm the so called high risk group the age related electrical conductivity scale and anomalous divergence in electrical conductivity distribution histograms between left and right breast are used Usage of Age Related Electrical Conductivity Scale The age related electrical conductivity scale with distinguished percentile ranges based on the examination of more than 2000 healthy women serves to form the high risk group Patients with anomalously low age related electrical conductivity of the mammary gland less than 5th percentile belong to the high risk group Such a value of age related electrical conductivity of the mammary gland indicates that the density of the ductal component of the mammary gland is high When this function on the program makes selection of the patients with anomalously low age related electrical conductivity of the mammary gland less than 5th percentile from the current database base address can be found in the top line of the window 0 70 0 65 0 60 0 54 0 50 0 45 0 40 0 34 0 30 0 28 0 20 0 15 0 10 005 n on Conductivity index 15 16171819202122232425 2527 20203031323233435 3837 28 38 30411 42432145 48277 28 28 30 81 52 53545556 5755528 BO 861852835465 Age ETT ET Hamep 137 Mihailyuk V V 1254386327 tdb 137 Mihailyuk VV 1254386556 tdb 137 Mihailyuk VV 1254386647 tdb 137 Mihailyuk VV 1254386747 tdb 137 Mihailyuk VV 125438687 4 tdb 137 Mihailyuk VV 1254386983 tdb 13
30. portant Electrical conductivity index 0 95 is considered as the cut off value between healthy mammary gland tissue and a noncomplicated tumour In case the cut off value with electrical conductivity index gt 0 95 sensitivity is 84 93 and specificity 87 99 gt according to the data given by different authors When this function on the program makes selection of the patients with pathologically high focal electrical conductivity of the mammary gland a characteristic feature of the small sized tumours from the current database base address can be found in the top line of the window B Date Selection 8 33 116 Tihomirova V L 1249546701 tdb a 116 Tihomirova V L 1249546762 tdb dM HH 55 Belkova V N 1240388458 tdb g M 8 apila V A 1241773960 tdb 72 Kozyreva N S 1243846128 tdb Cancer Manually 72 Kozyreva N 5 1243846230 tdb 72 Kozyreva N 5 1243846891 tdb 74 Alekseeva R G 1244124671 tdb 74 Alekseeva R G 1244124862 tdb 74 Alekseeva R G 1244125125 tdb 74 Alekseeva R G 1244125217 tdb 93 Cheremuhina N K 1246362444 tdb 93 Cheremuhina HN K 1246362969 tdb o Destination folder selection The selected patients are listed in the right hand window Double click patient s surname to load any patient s mammogram in the image field The list of the selected patients can be copied to any storage medium or printed High Risk Group Formation To f
31. rating the device keep it in the working area for at least 4 hours Set up the device e Unpack the device e Remove ties from the USB cable and the patient s coupling cable e Place the device together with the base on a plane surface close to the computer e Process the device using the following disinfectants in Russia the alcohol pads that came with the device or CIDEX OPA CIDEX PLUS or Meliseptol Rapid in Europe Canada and the U S the following disinfectants CIDEX OPA CIDEX PLUS The procedure is the following e Wipe the device base with the disinfectant e Take MEIK 5 0 in the left hand the cable down and process the electrodes array and the bottom of device body Place the device on the base and process the remote electrode Note the listed above disinfectants are highly effective have no adverse effects on the skin and human mucous membranes do not require ventilation do not leave a film on the electrode surface and do not change its electrical properties A Disinfection of the electrodes array and the bottom of device body having contact with skin is required after each examination and upon completing of operation When disinfecting the device shall be disconnected from the computer When processing the device please follow the instructions of the disinfectant manufacturer Try not to exceed the expenditure rate of solution or spray Connect the cable of the remote electrode to MEIK 5 0 A The
32. red dot found on the high precision latching connector LEMO Switzerland shall face the red dot on the socket of the device in order to achieve proper connection When needed to disconnect the patient s coupling cable from the device install the device on the base pull the ribbed clutch and remove the plug from the socket How to Prepare the Device for Operation Software installation Install the program in your computer from the CD following the instruction Connection to PC Connect the device to the computer with a cable through a USB port Use a plug to connect the external electrode with the device The green light on the upper panel of the mammograph indicates that the power is on Patient s Data Input Run MEIK software on your PC Two fields will appear on the screen image and controls field Patient s data 7s B Im 4 F B a Code Recent code i 1 in vel Name NCF LVL A 5 In order to enter a new patient click NEW and enter the patient code name and date of birth Patient s Card Filling Then click PATIENT S CARD and fill in the medical card of a patient 2 2 PATIENT PREPARATION 2 2 1 Patient position The examination is carried out on the massage couch the patient in a supine position Patients with small mammary glands may be examined in sitting position 2 2 2 Breast position The mammary gland shall be levelled frontally For this reason the
33. ring the reconstruction or Poor moistening of the breast or a Return to OOO PKF SIM scanning process the matrix dry ECG electrode or wire breakage technika Ltd for factory repair is filled in with yellow dots of the patient s coupling cable as adjustment or strengthening Further operation is Exposure to strong electromagnetic of EMI protection may be impossible interference transformers power required plants discharges Substantially increased System requirements mismatch see If change of PC laptop won t scanning or image this Manual no free space available help return the device to 000 reconstruction time on HDD if backup on remote HDD is PKF SIM technika Ltd for not performed factory repair For all technical issues and questions please contact OOO PKF SIM technika Ltd by phone fax 4852 79 58 67 or e mail sim tech net76 ru Address Russia 150054 Yaroslavl region Yaroslavl 2 Chkalova St office 223 6 WARRANTY The manufacturer guarantees that the electrical impedance computer mammograph MEIK 5 0 with Software Version 5 6 complies with the technical regulations of TU 9442 001 018100676 2003 with amendments provided that the consumer observes operating handling and storing rules Warranty lifetime 24 months from the date of purchase In case the factory seal is broken the manufacturer declines all the responsibility for the warranty repair of the device Produc
34. t life cycle till discarding 5 years At the expiration of product lifetime by agreement with the customer the complete modernization of the product may be performed by the Manufacturer with the replacement of major components and software Product is labelled with a new serial number and the effective date of sale Effective date is used to establish the beginning of product warranty period and service life In the event of the refusal to undertake the abovementioned measures the manufacturer is not responsible for performance degradation due to ageing and as a consequence degradation of diagnostic possibilities and diagnostic difficulties Manufacturer EU Representant OOO PKF SIM technika Ltd ONKOCET s r o 2 Chkalova St office 223 Kutuzovova 4 Yaroslavl 150054 Pezinok 902 01 Russia Slovakia Tel 7 4852 795867 Tel 421 2 446 40977 Fax 7 4852 795867 Fax 421 2 446 40977 www impedance ru www onkocet eu E mail sim tech net76 ru E mail onkocet gmail com Last revision 28 September 2012
35. y distribution of a patient with the norm The function of this icon is similar to that of COMPARISON WITH NORM button in the qualitative analysis field Click to restore the original values Attachment Icon enables to view the data attached to the measurement images or movies The attachments can be viewed using Windows default tools You may attach the data when creating your REPORT Supplemental Window Double click any image with the left mouse button to open a new window with additional information cursor coordinates and electrical conductivity at a given point In addition you can measure the dimensions of the area of interest In order to do this press and hold left mouse button and select the area of interest in the image The dimensions of the selected area in centimetres will be displayed in the second line of the table within parentheses Date 16 03 2007 13 31 Layer 1 Date 16 03 2007 13 31 Layer 1 0 0 0 5 1 0 0 0 Cursor X 5 1 sm Y 10 5 sm G 0 34 Hist X 0 0 12 2 Y 0 0 12 2 12 2 12 2 sm 0 5 Cursor X 11 9 sm Y 2 4 sm G 0 54 Hist X 2 0 9 5 Y 2 4 10 2 7 5 7 8 sm Mean 0 25 R M S D 0 13 Mean 0 29 Min 0 02 Max 0 77 Min 0 02 Extremum 0 21 Extremum 0 24 R M S D 0 13 Max 0 77 There are icons on the left with the same functions as the icons in the image field but they apply to the current image only Icon E displays a three dimensional image of the curr
Download Pdf Manuals
Related Search