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HemoFAXS 2.0 - User Manual

1. 62 5 8 4 2 telo Gro neas aiU Rm t 64 5 8 4 3 Approving slides for being tranSMitted ec ecccccccceeeeceeeceeeeseeeeseeeeaeeeeeeeeseeeeseeeeseeesaeeeseeeesaees 65 5 8 4 4 Transmission of the result into the hospital NEtWOFK c cece seccceeeeceeeeseeeeaeeesaeeeseeeeseeeeaeeeeaes 66 Page 2 of 84 www tissuegnostics com 5 8 5 LOJO TAD ne nett re nee ee 68 6 Microscope Maintenance and Operation ccccccccceeccceecceeeeeeeeeeeeeeseeeeseeeeseeesseeeseeeeseueeseeeesaeesseeeseueeseeeeseeetaes 70 Ols Cleaning the ellc NE ea en eC ne eee ee 70 6 1 1 cleaning the VOX ODI CCUY c a 70 6 1 2 Cleaning the 100x ODJOCUVE c 70 Oe COMOL ORO A omm m m 71 oe ME Se ren Miele NN EU tmm 71 6 4 Kohler Illumination only for HAL Systems ssesssssesessseeeeenneennm nennen nnne nennen nnn nnns 72 om Omer 5350196 al goog to gt aa aig Qoo m mtt 15 SAC mmm Nor RAO i gt EE eee en ee a ee eee 76 le Tones OOI ennai oe ne nei eran AE ee eee ee ee eee TT fAs oo gt 0018 gy AV Co doS ane ci MU mmm 77 7 2 HemoFAXS does not find cells in the 10x phase ce ecccccseececceeeeeeceescecceeseeeceeeeecseaseeeseaseeessegeeessaaes 77 7 3 HemoFAXS does not fi
2. DK Save As Ca d 20101005 0002 v s sercho o Organize New folder yr Favorites a5 Name Date modified Type EE Desktop images 9 1 2011 11 38 AM File folde Recent Places k 153 Libraries ES Documents al Music i Pictures BE Videos Ll Computer amp Windows C roa Filename WUER ines Save as type PNG Files png Figure 65 Export Dialog In the Export Dialog you can choose 1 Where to store the exported image on your hard disk 2 The name of the exported image Page 46 of 84 www tissuegnostics com 3 The format of the exported files bmp jpeg png tiff After selecting the path and the files format press Save button to effectively export the chosen image s Press Cancel to quit export Add Comment For any image you can add a comment that is defined by a tag Choose Add Comment option type the desired tag it will be memorized in the Tag dropdown list and then write your comment in the Comment field Press OK button to save the comment or Cancel to quit Comment Content Figure 66 Tag Comment dialog If an image has a comment a little yellow T letter will appear on it like shown in the image below Figure 67 Tag marking on the image Comment Tag History You can see the comments tags added to an image by accessing the context menu and pointing with the mouse over Comment Tag History The History displays the following information date an
3. Input Patient Data panel 5 8 1 2 Settings Entering slide count Lad Using the arrow controls adjust the number of slides to be analyzed Number of slides l2 Figure 43 Changing the count of slides Actual Sample ID The actual sample ID can be set by entering the number into the corresponding field highlighted in the figure below SampeNr 8 31 2011 H Mame BrthDate 8 31 2011 Ward Diagnosis Figure 44 Setting sample ID Patient specific data In this section essential data concerning the patient will be registered e Sample arrival date e Patients name e Patient s birth date Page 34 of 84 www tissuegnostics com e Hospital ward where the patient is located e Patient s diagnosis Sample Mr Name BirthDate Ward Diagnosis 11 8 2011 Wr 101443004 patient s name 11 8 2011 v ward where patient is treated patient s diagnosis Figure 45 Patient related data Maximum number of cells per slide here you can set the desired number of cells per slide by using the i arrow buttons But in order to do this you must have a project created first 4 The number of cells cannot be changed during acquisition This setting applies to all sf Note future slides 5 8 1 3 Camera Within the Acquisition tab you can find the Camera control panel rote You can automatically perform the focus by pressing the middle button on the mouse Ly You can
4. Page 17 of 84 www tissuegnostics com 5 1 3 Morphology L i iiaa E gm M nm ee re E Figure 11 Morphology Tab The Morphology tab contains the following sections see image above e Current project control 1 e Current slide control 2 e Zoom control 3 e Morphology viewing window 4 e hrombocyte morphology controls 5 e Erythrocyte morphology controls 6 e Leukocyte morphology controls 7 e Scroll Bar 8 Page 18 of 84 www tissuegnostics com 5 1 4 Results ae ee A FEET PSs high ot b d i Site Name Sample Summary Semple De a 13 10 2011 Same Wr DOOOODOOOD Palit Ham Patient Birthdate 11 10 2011 ward Cage Classification Result y Figure 12 Results Tab The Results tab contains the following sections see image above Current project control 1 Current slide control 2 Zoom control 3 Comment box 4 Report viewing window 5 Add Comment button 6 Approve Slide button 7 Transmit slides button 8 Page 19 of 84 www tissuegnostics com 9 1 5 Logger M MM Mb CIC Gabe a E eee a DE IB Figure 13 Logger Tab The Logger tab contains the following sections see image above e Slide section 1 e Status section 2 e Date section 3 e Severity section 4 e Message section 5 9 2 New project 5 2 1 Create a new project To create a new project press New button in the left corner of the main to
5. then move them into the respective class You can perform the manual classification in two ways First method Page 42 of 84 www tissuegnostics com 1 Selection e To select one cell left click on the image of the desired cell e To select nonconsecutive leukocyte images press and hold Ctrl key then left click each item e To select a range of cells consecutive images press and hold Shift key pressed left click on the first image of the desired cell range then click on the last image Select one cell with a left click select nonconsecutive Select consecutive cells cells using Ctrl key using Shift key Figure 59 How to select leukocyte images After manually re classifying an image a little green M letter will appear on it like shown in the image below i r kg j Figure 60 Manual classification marking on the image 2 Move to the desired class e Finally drag and drop the selection in the desired class Page 43 of 84 www tissuegnostics com Monocytes J Basophils Figure 61 Assign a leukocyte to a subclass Second method 1 Selection e To select one cell left click on the image of the desired cell e To select nonconsecutive leukocyte images press and hold Ctrl key then left click each item e To select a range of cells consecutive images press and hold Shift key pressed left click on the first image of the desired cell range then click on the last image Page
6. 44 of 84 www tissuegnostics com 2 Move to the desired class e Press the corresponding button from Cell Class Type section Eosinophils H Basophis Do Cel I Clar pe Viewed Count Percent mm D B o ses Eosinophils _ Figure 62 Assign a leukocyte to a subclass second method 5 8 2 2 Measurement feature This feature helps you determine the dimensions of a cell e From your keyboard keep pressed F9 key or any other key this feature is configurable and use the mouse to draw a line over the desired object from the image The length of the line will be automatically displayed expressed in um e Release F9 key to exit Measurement Figure 63 Measurement feature 5 8 2 3 Context menu for a leukocyte Each cell image has a context menu which you can access by right clicking on any image Page 45 of 84 www tissuegnostics com Export Image Add Comment Comment Tag History Classification History Post Processing Reclassified 0 00 Add to Report Remove from Report Figure 64 Context menu The context menu is composed of Go To Cell If choosing Go to Cell the microscope will go to the respective cell In order to go to a certain cell the slide from where the cell was taken must still be on v4 e stage in the same position and the system should not be recalibrated in the meantime Export Image By choosing the Export Image option the following dialog will appear
7. 84 www tissuegnostics com Go to Cell Export Image Add Comment Comment Tag History Classification History d Fost Processing Reclassified 0 00 Add to Report Remove from Report Figure 82 Adding image to Report In the Results tab the image added to Report will look like this ue EraLan cree Qu IE Cami bes Syme Lpr yH remm LES Fermeri u Era m race LEN n Er E E d Mrsiocetm FL Figure 83 Results tab Evaluation Images The application allows you to make a multiple selection of the cells to be added to report Simply by pressing CTRL LEFT CLICK on the mouse you can select the cells you want to add to report When making a multiple selection of cells to add to report if you reach the maximum s ff Note number of images that can be added to report a warning message will appear Page 57 of 84 www tissuegnostics com i You have exceeded the maximum number of images in the Report 0 gt currently in the report 8 gt to be added in the report 3 gt MAXIMUM allowed Please make sure you don t exceed this limit Figure 84 Add to Report message box To remove an image from the Report there are two options In the Evaluation tab select desired image then press Remove from Report option from the contextual image see image below Go to Cell Export Image Add Comment Comment Tag History Classification History Post Processing Rec
8. Slide 5 W Slide 6 W Slide 7 W Slide 8 ml a uu G 2 623 2 Co Ld Figure 51 Acquisition scanning slides In order to start the acquisition press OK Page 39 of 84 www tissuegnostics com Acquisition Skip current slide ee ee Stop Finish scanning Project 1 Scan all slides from Project 1 Select slides to scan Figure 52 Acquisition controls If you press the arrow on the Scan button a dropdown menu will appear It includes the following options Finish scanning if choosing this option HemoFAXS will scan only unacquired slides Scan all slides from will scan all existing slides Select slides to scan see Chapter 5 8 1 9 5 8 1 5 Stop the acquisition To stop the acquisition you have to press the Stop button The Acquisition Analysis will stop as soon as possible Figure 53 Stop button in the Acquisition section Also during the acquisition the Stop button is present on every tab of the application in the upper right corner so you can stop the process without the need to return to the Acquisition tab Also a process bar with details is available on each tab Acquiring Slide 2 from Project 1 Monolayer a Figure 54 Stop button and process bar on every tab 5 8 1 6 Skip a slide Sometimes it can happen that a slide is no more needed or the next slide is needed first HemoFAXS comes with the right solution the Skip current
9. and Role of the Administrator ote Change password To change the password press Change password dialog In the Change User s Password that appears write the new password And then re type the new password and press OK to save the changes Mew password Re type new password Figure 39 Change password dialog Delete user To delete a user first select the user to be deleted in the list from User Management dialog then press the Delete user button A message box will appear where you have to confirm the deletion of the user hr m All the users can be deleted excepting the Administrator P Note Page 32 of 84 www tissuegnostics com Administrator Administ ator Administ Demo User Demo User Test Figure 40 Delete user 5 7 2 If logged in as Standard User If you are logged in to HemoFAXS as a Standard User the only available operation will be Change Password Figure 41 Available options for Standard User 5 8 Sample Analysis 5 8 1 Acquisition Tab 5 8 1 1 Input Patient Information Input Patient Data panel gives the opportunity to manage up to eight patients in a single analysis and it helps organizing the information concerning each patient Page 33 of 84 www tissuegnostics com Number of slides i Slide 3 Sample Nr 11 8 2011 E 101443604 Name patient s name BirthDate 11 8 2011 Ward ward where patient is treated Diagnosis patient s diagnosis Figure 42
10. e Sample Number e Patient Name e Ward e Comment e Diagnosis e All Search Options e Match Case enables case sensitive search e Find whole words only will only search whole words After checking the desired criteria press Search button The generated results will be listed in the Search results section For each entry the following data is shown e Sample Number e Patient Name if available e Ward if available e Diagnosis if available e File Path Page 29 of 84 www tissuegnostics com There are two ways to see a certain sample listed in the Search results section you can select the desired sample and then press Go to Slide button or you can double click on the slide in the list HemoFAXS will automatically go to selected project 5 7 Manage Users 5 7 1 If logged as Administrator If you are logged into HemoFAXS as Administrator you will be able to manage the users in HemoFAXS Just press Manage users button in the upper right corner of the application Manageusers J low Figure 35 Manage users button The User Management dialog will open On its left side the users are listed along with some related data such as Real Name Login name and Department On the right side you can find a set of controls Add new user Modify user Change password Delete user and Close Real Name Department Administrator Administrator Administr Service Service Service Figure 36 User Man
11. large sources of vibrations e g centrifuges many images could be blurred oeveral different anti blurring algorithms are integrated into the system nevertheless some vibrations could cause blurred images If there are no sources of vibrations near the system please read the points below sometimes HemoFAXS focuses onto dirt therefore it finds the focus plane only partially Please check if there is any dirt on the slide and if HemoFAXS is focusing on it Please activate the camera during the focusing of the system If you find dirt or bubbles see Chapter 6 1 f f Images are black If the images are darker than usual or if they are completely black please check the functionality of the lamp see Chapter 6 2 Please ensure that the condenser is correctly centered see Chapter 6 3 Please check the illumination and the staining through the phototube If there is no image at all even if the light is illuminated correctly and the condenser is centered well please call your HemoFAXS technician as soon as possible Page 79 of 84 www tissuegnostics com 7 8 Colors are not correct e Please ensure that the lamp is activated and fully functional see Chapter 6 2 e Check the illumination and the staining using the camera If the staining is seen correctly through the tubes but not on the computer please call your HemoFAXS technician as soon as possible Page 80 of 84
12. perform the focus manually by using the scroll wheel to move the Z drive Use the ALT key CTRL key or ALT CTRL key combination to increase the speed of the Z drive movement Page 35 of 84 www tissuegnostics com Figure 46 Camera control panel with Live Image enabled 1 Camera Viewer displays the live image from the camera NO Magnification Settings e Low magnification moves the objective to 10x and loads the specific settings TL Lamp and camera settings e High magnification moves the objective to 100x and loads the specific settings TL Lamp and camera settings If nothing can be seen when pressing Settings buttons check the system camera sf Note connection light path light intensity If everything is on but still nothing can be seen call the Support team 3 Camera Live Image e Check Live Image checkbox to activate camera live image e Uncheck Live Image checkbox to deactivate camera live image Video settings it is not recommended to change the Video Settings as this may severely disrupt sf Note HemoFAXS function if done improperly Press Settings button to access PixeLINK Camera Settings dialog Page 36 of 84 PixeLINK Control Panel Exposure Time ms B D 10 Saturation 95 0 00 White Balance www tissuegnostics com Gain dB B 0 00 Gamma 1 00 Color Temp K Red Cy oe 3200 00 3200 00 Auto 6500 00 Blue Flip Binning E Hori
13. problem Please close HemoFAXS and turn off your computer and the microscope Please wait 10 seconds before starting the microscope and the computer again Please check if the condenser s lens is correctly centered If the condenser is not well centered it should be centered again manually see Chapter 6 3 Please check if the lamp is activated and that it is working properly see Chapter 6 2 If the lamp does not work properly please check if it is activated If it is activated but does not emit light please adjust the intensity to 2 3 of the maximum If there is still no light you might need to change the lamp Activate the camera and see if the image is blurred Stop the acquisition and view through the phototube if the objective is dirty or oily If this is true please clean the objective see Chapter 6 1 7 3 HemoFAXS does not find cells in the 100x phase Please see if the slide has air bubbles in the immersion oil Activate the camera and check the live preview for the existence of bubbles in the oil If there are any bubbles please stop the acquisition and clean the objective see Chapter 6 1 If the problem persists please check if the staining procedure changed in any way This can be verified by reacquiring an already acquired slide If the slide is acquired again the staining procedure could have changed If it fails again please go on to the next step 7 4 HemoFAXS does not find a focus plane 100x Please che
14. the computer e Please ensure that there is no other process which uses CPU performance in the background If a process takes nearly 100 of the CPU there is no more processing power left for He moFAXS Please ask your system administrator to solve this problem CPU Memory Private Working Set Description og 120K Windows Command Pr 00 196K Console Window Host 00 9 180 K 00 600K DAEMON Tools Lite i 02 29 876K Desktop Window Mane 01 13 056K Windows Explorer firefox exe 00 373 016 K Firefox HemoFAXS exe 00 48 532K HemoFAXS exe net exe 00 152K Net Command OUTLOOK EXE Oz 10 676 K Microsoft Office Outloi plugin container exe 00 7 956K Plugin Container for Fi plugin container exe 00 6 224K Plugin Container for Fi RtHDVCpl exe g0 660K Realtek HD Audio Man 00 3 960K SJphone 1 65 Processes 65 CPU Usage 40 Physical Memory 6 Figure 114 CPU Usage except HemoFAXS and System Idle Process no process should have more than 50 e Please deactivate all applications and programs which could have any impact on the performance of HemoFAXS e g antivirus disk defragmenter scandisk 7 2 HemoFAXS does not find cells in the 10x phase e Please ensure that the stage can be moved along the z Axis by using the manual wheels like in the image below Page 77 of 84 www tissuegnostics com Figure 115 Z Axis of the stage If the stage does not move along the z Axis it means that the microscope experienced a
15. the selected files failed to be opened In both cases you will receive a warning message The following projects failed to open ub 201110110032 hfproj Figure 25 Opening project message box 434 When the maximum number of project files to be opened is reached you will receive sf Note a message box In order to continue you will have to select the maximum number of projects that the application allows you to open then press OK Page 25 of 84 www tissuegnostics com Select maximum 8 projects F HemoFAXS Projects 20120202 20120202000 1120120202000 1 hfproj F HemoFAXS Projects 20 120202 201202020002 201202020002 hfproj F HemoFAXS Projects 20120202 201202020003 201202020003 hfproj F HemoFAXS Projects 20 12020220 1202020004 20 1202020004 hfproj F HemoFAXS Projects 20120202 201202020005 201202020005 hfproj F HemoFAXS Projects 20120202 201202020006 201202020006 hfproj JF HemoFAXS Prajects 2012020212012020200071201202020007 hfpraj JF HemoFAXS Prajects 2012020212012020200081201202020008 hfpraj JF HemoFAXS Prajects 2012020212012020200091201202020003 hfproj JF HemoFAXS Prajects 2012020212012020200101201202020010 hfpraj JF HemoFAXS Prajects 2012020212012020200111201202020011 hfpraj JF HemoFAXS Prajects 2012020212012020200121201202020012 hfpraj ME WemnF ays Prnriectelan120202V30n1 20202001 3V30n1 20203001 3 hfnrni Figure 26 Opening projects message box All the projects y
16. to Cell e Export Image e Add Comment e Comment Tag History e Post Processing e Add to Report e Remove from Report For a detailed description of these options please see Chapter 5 8 2 5 8 4 Result Tab The last step of HemoFAXS analysis is called Result In this tab you can visualize the final results obtained through the previous steps Page 61 of 84 www tissuegnostics com Site Logo Site Name Sample Summary Senge Cate a ILIGI Bare Hr 1201445104 Poieni Garthetate DA 11 2011 u gjeje dasma 9 Figure 90 Result tab 5 8 4 1 The Report The main section of the Result tab consists of a report with information about the results of the analysis Page 62 of 84 Sample Summary Sample Date 12 12 2011 Sample Nr 0000000000 Patient Name Patient Birthdate 12 12 2011 Ward Diagnosis Classification Result 2 Relative Eosinophils Basophils Lymphocytes Monocytes Atypical Lymphocytes Plasmocytes Metamyelocytes Myelocytes Promyelocytes Blasts Thombo Reaktive Lymphozyten Kernschatten Debris Leukocytes overall Normoblasts Not classified oOooorroooooscr www tissuegnostics com Morphology 3 e No morphological problems Comment 4 Eosinophils Monocytes Figure 91 Results tab Report Info resumes the information about the patient Date of the sample Number of sample Name of the patient Birth date of th
17. 020 Vienna Austria 3 Mfg date Serial number W WEEE symbol separate disposal of electrical and electronic equipment C CE mark Date of Manufacture esl Manufacturer Notice regarding anti virus applications e All the TissueGnostics products are shipped with the Kaspersky Anti Virus in order to ensure optimal functionality e Therefore TissueGnostics only guarantees for Kaspersky Anti Virus to work with its products e The user may decide to use other anti virus software only upon own responsibility e Any problem that arises due to other anti virus software installed will void TissueGnostics warranty and every support or service action required by the client in order to restore any of TissueGnostics damaged instruments will be billed to the customer Notice regarding immersion oil e All the TissueGnostics products are shipped with TissueGnostics immersion oil order no TGHe3 416 TGHe3 416a TGHe3 416b in order to ensure optimal functionality e Therefore TissueGnostics only guarantees for TissueGnostics immersion oil order no TGHe3 416 TGHe3 416a TGHe3 416b to work with its products e The user may decide to use other immersion oil only upon own responsibility e Any problem that arises due to other immersion oil will void TissueGnostics warranty and every support or service action required by the client in order to restore any of TissueGnostics damaged instruments will be billed to the customer Pag
18. M PM 20 0 2 2 SOT IMG storage e eri o xicscsicrcedcnecesctsvensacdecearacuavzerxedsdeccesseeninaicdsesecteyeutieedseeesecususeiaededsosecusebineedadeeuedsees 21 s MEE O11 gt Hy 0 E nn een a ee ee re a een eee ee ee eee eer 22 5 4 SAVE GNC close a projeCi eres cectisesenecdevecwustneinadeddacedved senzccusdeesavesdsvbadeedadeqvasaeysarsadeeecussdsehovaedsescsueusveesiueveevieeicees 26 Sae FPA eA ON i tcc cee 2 36 Vinos Toce NP eee 28 Ch Manage SS ance ss whet naira 30 5 7 1 if logged as AGING AION MN OE 30 5 7 2 If logged in as Standard User ccccccccsecccssccceeeccseeceececaueesaeeceseeseueesaueesaueesaeeeeseeseueesseeesseesneeeseeeess 33 90 ne 228 I enk eie i o aa ee eee een E een eee kee 33 5 8 1 pee iem HEL 33 5 8 1 1 ITEC FAUST NIMAU sash mmm 33 5 8 1 2 SALLA S states e 34 5 8 1 3 RAMU M ET 35 5 8 1 4 A WV eA eU cir e CNN Roms 39 5 8 1 5 SO ll a MN SIO e 40 5 8 1 6 qjos E 6 cee A E A ere ee ee eee ee E eee eee ee eee 40 5 8 1 7 Fe TMI Wigs ANN siete c Y 40 5 8 1 8 Ses EES SIN ON tects pec ae suscep st wis ise acted coe E ae sorts sm 41 5 8 1 9 OIC SIO S O SOON usce soe artisq T a D O
19. O ESon E MGIS iS eq IUD OI EUN EPI M UIN US IM MM DIESE 41 5 8 2 EV QIMAMONN Mell c M 42 5 8 2 1 Assign a Leukocyte tO a SUDCIAS Sis i paises ten inae iUt bonu pups S as Dos ON IURI MN Ta R c Diu MESE Deo ON OUR EIUS MEUS MA 42 5 8 2 2 Measurement 1S iL BTE RR P M 45 5 8 2 3 CONTEXT menu Tor Bio iem mE TT 45 5 8 2 4 ISOlloVerdmiage edllilb ess ues save sade oxi a UM I eden TE Ea 49 5 8 2 5 Classes Of CU OC VIO accendseiesieus ime luteo usce a cen ibl ae ta mretu itp PR Hep du Ep PR pM crema eun 50 5 8 2 6 OMG Soe T 52 5 8 2 7 S161 e Bo EE E ene E en eee E A A ee ee ee eee ee E 53 5 8 2 8 column i Pay rere E E E eee S 55 5 8 2 9 Adding images to Report scccceseeccceasacetiveictesetorenceencamedonsscueabvosetesstneeancbnedieiucaseeeGineceeccdaceuteaiee need 56 5 8 3 BNC TAD seeren gian steeper lp tes pit lt EENE E E 58 5 8 3 1 Select a morphology feature cceccceecccseeceseeceeeeceueecaeeceacecsueecsueesseeesueeceaeessusessueeseeessaeessaeess 60 5 8 3 2 Select a morphology grade of a feature sesssssssssssssssssssseee nennen nennen nennen nns 60 5 8 3 3 Contextual menu for morphology IMAGES ccceccceeccceeeeee cece eeseeeeseeeeseeeeseeeeeeeeseeeeseeesaeeesaeeess 61 5 8 4 RicNMI om 61 0 8 4 1 TFG APSO OI M c
20. Plasrmocytes i Segmented 53 58 83 75 Banded 0 00 4 Metamyelocytes 2 00 A Myelocytes 1 1 30 Pr rmyelecytes 1 1 30 Binst 0 00 s Hormoblasts Thambe Reaklive Lymphoryten Kernschatten Debris Leukocytes overall 77 100 00 9 o Morphology No morphological problems See comment in the Report Comment Demo comment Figure 92 Results Comment You can print the report by pressing Print button from the main toolbar of the application Please see Chapter 5 5 Page 64 of 84 www tissuegnostics com 5 8 4 3 Approving slides for being transmitted transmit them To approve a slide press the Approve Slide button tab After approving a slide you will receive a confirmation message box Figure 93 Approve Slide message box Evaluation tab If not the Approve Slide button it will appear disabled see image Ar z In order to be able to approve slides you have to visualize first all cell classes in the o below Acmguisitian Evaluaten C use Sample Summary sample Date 08 12 2011 Sample Nr i 1 014d4104 Patent Name Patent Birthdate aB 11 2011 Ward Diagnosis Classification Result Morphology No morphological problems Site Name Eosinophils Basophils Lymphocytes Momiecytes Atypical Lymphocytes Plasmocytes Segmented Banded Metamyelocytes Myelezyteg Promyelocytes Blasts Figure 94 Results tab Approv
21. Press Open button to load the project or Cancel to quit the browser Page 22 of 84 www tissuegnostics com Look in 1202080181 er Ee m Name Date modified Type 6 10 2010 9 07 AM File folder 12 2 2009 4 31 PM HQPROJF VE Recent Flaces Desktop di images 1202080181 hqproj n t 1202080181 hane HemoQuest Project Files hapraj Cancel File name Files of type Figure 19 Browse for project dialog Select Open multiple projects option to open more projects at one time The Open dialog will appear where you can browse for the desired projects Select desired projects by using Shift Ctrl keyboard combination Press Open button to load the projects or Cancel to quit the browser E Am i Computer Data 2 F Organize Mew folder WT Favorites _ Libranes IE Computer Vli Network amans Hermie d 21202020001 js m1m d 201202020003 b 201202020004 Je 201202020005 js 201202020006 201202020007 4e 201202020008 je 201202020010 Je 201202020011 Je 201202020012 Je 201202020013 Je 201202020014 je 201202020015 de 201202020016 Dst rmndsisd 2 2 2012 1449 PM 2 2 2017 1443 PM 2 2 2012 1 48 PM 2 2 2012 1 49 PM 2 2 2032 1 49 PM 2 2 2012 1 49 PM 2 2 2012 1 40 PM 2 2 0012 148 9M 2 2 2002 1 49 PM 2 2 2012 1 48 PM 2 2 2017 1 49 PM 2 2 2002 1 48 PM iii LAG PM 2 2 2002 1 48 PM 2 2 2012 1 48 PM 2 2 2017 1348 PM Type File
22. Rescan option is not available as you can not repeat the operation V To perform a rescan operation you have to stop the analysis first If there is no project ote until you have at least scanned an item once The analysis will not continue from where it was stopped and the previously gathered data will be discarded Page 41 of 84 www tissuegnostics com To effectively use this feature press Select slides to scan option from the Scan button The following dialog will appear Figure 57 Rescan dialog In the Select Slides dialog you can find the following items The list of available slides you can also mark the checkboxes for the ones you want to rescan 1 A short description for each slide 2 Select All button 3 will select all available slides Select None button 3 will clear the selected slides Cancel button 4 will exit the Rescan process OK button 4 will effectively start the rescan process 5 8 2 Evaluation Tab In HemoFAXS the classification of the acquired leukocyte images is fully automatic However sometimes the user must intervene and manually reclassify the leukocytes or assign non classified cells After automatic classification of an image a little red A letter will appear on it like shown in the image below Figure 58 Automatic classification marking on the image 5 8 2 1 Assign a Leukocyte to a subclass To attribute images to a specific class select the desired images
23. ab or a lint free cotton cloth soaked with EtOH you can clean the lens of the objective with slight pressure and circling movement For better results you should demount the objective before cleaning An x TissueGnostics only guarantees for the use of EtOH Ethanol o Figure 101 Cleaning the objective 6 1 2 Cleaning the 100x objective The 100x objective should also be cleaned regularly because the oil getting collected on the front of the lens will generate bubbles after some days These bubbles are a problem for the auto focus The objective should be cleaned daily with a cotton swab or a lint free cotton cloth and weekly by using 70 EtOH Ethanol TissueGnostics only guarantees for the use of EtOH Ethanol Page 70 of 84 www tissuegnostics com 6 2 Control of the lamp The lamp of HemoFAXS is a component having a specific lifetime Therefore the lamp should be checked at least once a year for full functionality After starting the microscope set the intensity to the level shown in the image below Figure 102 Lamp at 2 3 of its maximum intensity Check the light from the condenser If the condenser is not brightly lit as shown in the image below the lamp should be changed Figure 103 The lamp works properly 6 3 The Condenser position The condenser is used for achieving the proper focusing of the light onto the focus plane If the condenser is not centered the leukocyte image may
24. agement dialog Add new user To access Add New User dialog press Add new user button To add a new user some information must be provided in the given fields e Username the desired username e Real name the real name of the user e Department the department to which the new user belongs e Role there are two possibilities Administrator or Standard user e Description enter a short description of the new user optional e Password enter desired password e Re type password re type chosen password e Press OK to create the new user Page 30 of 84 www tissuegnostics com User name Real name Department Role Standard user 1 Description Password Re type password 7 Figure 37 Add New User dialog Modify user You can modify user related data at anytime Just press Modify user button and modify desired information in the corresponding fields e Username the desired username e Real name the real name of the user e Department the department to which the user belongs e Role there are two possibilities Administrator or Standard user e Description enter a short description optional e Press OK to save the changes Page 31 of 84 www tissuegnostics com User name Demo user Real name Demo user Department Test Role Standard user Description Figure 38 Modify User dialog i You cannot change the Department
25. asing the image contrast in the area immediately around the edge This has the effect of creating subtle bright and dark highlights on either side of any edges in the image Gamma adjusts the contrast of the image You can use this to highlight the differences between the light and dark areas or in order to minimize these differences Hue the property of colors by which they can be perceived as ranging from red through yellow green and blue as determined by the dominant Saturation represents the purity or strength of a color due to absence of black white or gray Adjusting color saturation will affect how intense the tones of the color are in your image Use this in order to enhance colors on tissues with faded colors Value adjusts the brightness of the image separately from the saturation After modifying the above parameters press Apply button to apply the new settings to all currently opened projects Also the future projects will inherit the new settings Default button provides three options Load Default will restore the original settings Reload slide settings will restore the slide settings Disable Post Processing will clear all post processing modifications Load Default Reload slide settings Disable Post Processing Figure 71 Load Default dropdown box Cancel button will exit Postprocessing Dialog Reclassified cells percentage The reclassified cells percentage shows the percent of r
26. asswords of current Administrator and User Can add other Administrators or Users Can modify existing accounts Can delete other Administrators and Users except his account The User can change his password Page 14 of 84 www tissuegnostics com 5 User Interface 5 1 Utility Bar HemoFAXS comes with an intuitive user friendly interface as seen in the image below Sri I im la 10 11 2011 Be 10 11 2011 Figure 8 HemoFAXS main window The main window contains 5 tabs which represent the steps to be performed for each analysis e Acquisition see Chapter 5 8 1 e Evaluation see Chapter 5 8 2 e Morphology see Chapter 5 8 3 e Results see Chapter 5 8 4 e Logger see Chapter 5 8 5 The main window also contains the buttons corresponding to the essential actions to be performed in the application some buttons might be disabled if no project is opened e New with this button you can create a new project for analysis see Chapter 5 2 e Open this button opens an already finished analysis from your storage media see Chapter 5 3 e Close this button will close currently opened project Page 15 of 84 www tissuegnostics com Manage users manages the users of HemoFAXS see Chapter 5 4 Language you can select here the language to be used for HemoFAXS graphical user interface Save this but
27. ation Figure 3 HemoFAXS Login Dialog Press Cancel to quit application fn If the dongle is not inserted HemoFAXS will return an error message ote If your license expires HemoFAXS system cannot be used anymore In order to renew you license please contact your HemoFAXS service engineer You should request a new license in 30 days before the old license expires in order to have continuity in using the application Page 12 of 84 www tissuegnostics com amp Failed to validate your license Please check your dongle or contact the support team Protection violation CRYPTO BOX not found or contains no valid data Figure 5 HemoFAXS Login message box A splash screen will be displayed while the application is being initialized Initializing microscope device Figure 6 HemoFAXS splash screen HemoFAXS application automatically locks if not used for a while Enter the user name and the password in the Unlock dialog to unlock the application then press Unlock button Page 13 of 84 www tissuegnostics com Enter your user name and password to unlock HemoFAXS User name Administrator Password BPhbrbbR RX PRRPERERPET Figure 7 HemoFAXS Unlock Dialog For optimal management of the application HemoFAXS is provided with a hierarchy of users as it follows e Administrator eUser The Administrator has control over the current Administrator and User Can change p
28. be compromised Page 71 of 84 www tissuegnostics com Centering The condenser has to be centered for each image acquisition _ Figure 104 Condenser is correctly centered If it is not properly centered the user has to center it manually Figure 105 Condenser is not centered To accomplish this operation switch back the lever at the side of the condenser The Kohler illumination is a setting of the condenser and it is needed to focus the light onto the same plane as the cells are For this operation you have to close the luminous field diaphragm Page 72 of 84 www tissuegnostics com Figure 106 Opening and closing luminous field diaphragm Then focus onto the cells of an image Figure 107 Blurred light path grey Finally move the condenser to the position where the light is focused Figure 108 Light path focused Page 73 of 84 www tissuegnostics com Figure 109 Wheel to adjust the focus position on the light path Now open the luminous field diaphragm again until the view reaches the border Figure 110 Light path slightly opened Try to center the bright circle with the two screws on the condenser Page 74 of 84 www tissuegnostics com Figure 111 Screws to adjust the position of the light path Finally open up the luminous field diaphragm completely Kohler illumination should be checked at least once a year or when the user detects any malfunction The ins
29. cells at the calculated positions Validation of the acquired cell images to prove that the acquired object is the cell of interest 5 Classification of the cells with a Support Vector Machine SVM this classification will be done by using more than 89 parameters 6 Presentation of the cell images to the user at high resolution and in a pre classified form 7 Validation of the classification results by a qualified and trained expert 8 Transmission of the results into the hospital IT network of the customer optional 9 Exporting the report and or printing it optional Page 11 of 84 www tissuegnostics com 4 Login In order to start HemoFAXS application double click on the HemoFAXS icon on your desktop HemaF AXS After starting the application a Login panel will appear In order to login to HemoFAXS you must enter a username into the User Name field and type the proper password into the Password field Press Ok to authenticate Enter your user name and password to login to HemoFAXS User name Administrator Version M F TEILIUEPERM Password sssasesesesne 20120127 01 Copyright 2005 2012 TissueGnostics GmbH All rights reserved Figure 2 HemoFAXS Login Dialog If the username and password are correct the HemoFAXS Login dialog will close and you can start using the application Otherwise the application will prompt again for a valid username and password combin
30. ck that the stage can move along the z Axis After the startup of HemoFAXS during calibration the stage should move down to the lowest position possibly and afterwards back up again If this does not happen please restart the microscope and the HemoFAXS see Chapter 7 1 If the stage is moving but the images are still blurred please activate the camera HemoFAXS probably focuses on a position where no cells are present or dirt is the best object to focus on If no cells are present please stop the acquisition insert the slide with the label placed in the opposite side see figure below and repeat the scan Page 78 of 84 www tissuegnostics com Figure 116 Lock slide in opposite direction If the focus is performed on some dirt try to clean the slide as much as possible To clean the slide use chemical wipes only Never use fluids in order to clean the slides There is also possible that the light conditions are not proper Please refer to Chapter 6 2 7 5 HemoFAXS does not classify automatically Please restart HemoFAXS and wait one minute before starting the acquisition Please ensure that the staining method has not changed By using the manual phototube ensure that the staining and the illumination are correct If there are big differences between the manual image from the microscope and the image acquired by the computer please inform your HemoFAXS technician 7 6 Images are blurred If HemoFAXS is installed close to
31. ctor e 1 Serial Connector 9 Pin D Sub e Screen Resolution of at least 1600x1200 Pixels Recommended system requirements e Intel Core i7 gt 2 5 GHz e 4096 MB Main memory e Hard disk RAID 1 e Screen Resolution of at least 1920x1200 Pixels 5 Depending on the performance of the processor installed the overall performance of sf Note the system can be improved during execution of HemoFAXS Notice regarding virtual machines TissueGnostics software is not meant to work on virtual machines Also TissueGnostics does not offer support for these configurations as the software directly uses advanced CPU features and therefore any third layer between the software and the CPU will affect performance and might affect the results of the analysis in an unpredictable Way Page 9 of 84 www tissuegnostics com 3 Overview The idea behind HemoFAXS was to offer a system which everyone can make use of while involving only a minimum amount of personnel and temporal resources Most settings are performed during installation by a qualified technician These settings are not changeable by the customer and guarantee a standardized work This offers the possibility to compare results over different systems During the acquisition the inhouse developed focus algorithm will deliver excellent images regardless of the used magnification This algorithm is afterwards internally validated during runtime Additionally in order to avoid possible disturbanc
32. d time user tag name comment Go To Cell Export Image Add Comment Comment Tag History d Classification History Post Processing a E Figure 68 Comment Tag History Page 47 of 84 www tissuegnostics com Classification History For any image you can see the Classification History if available by accessing the context menu and pointing with the mouse over Classification History i30 To Cell x Export Image e Add Comment Comment Tag History d Classification History b 04 ImageQ00003 Automatic Monocytes Post Processing 12 2 2009 2 41 41 PM HemoQuest gt Atypical Lymphocytes Figure 69 Classification History Post Processing Post Processing section contains a set of adjustable parameters for enhancing the quality of acquired images 200 ial Contrast Loo L Sharpness Unsharp mask 3x3 Gamma f o 2 20 Visual Gamma es Saturation 100 00 Value Figure 70 Postprocessing Dialog e Brightness adjusts the luminosity of the image e Contrast the contrast is the difference in visual properties that makes an object or its representation in an image distinguishable from other objects and the background Page 48 of 84 www tissuegnostics com Sharpness the filter works by identifying sharp edge boundaries in the image such as the edge between a subject and a background of a contrasting color and incre
33. e 5 of 84 www tissuegnostics com Notice regarding moving and or relocating of the system microscope e All TissueGnostics products are configured and calibrated in order to ensure optimal functionality e Therefore TissueGnostics only guarantees for optimal functionality if the system microscope is not moved relocated after the installation e he user may decide to move and or relocate the system microscope exclusively on his own responsibility e Any moving and or relocating of the system microscope not done by TissueGnostics will void TissueGnostics warranty and every support or service action required by the client in order to restore any of TissueGnostics damaged instruments will be billed to the customer Please contact TissueGnostics to have your system moved and or relocated to maintain warranty Please be advised that such a move and or relocation after primary installation is liable to cost Notice regarding installation of software e All TissueGnostics products come pre installed with the necessary software in order to ensure optimal functionality e Therefore TissueGnostics only guarantees for pre installed software or software which was tested by TissueGnostics to be compatible to work with its products e The user may decide to install other software only on his own responsibility e Any installation of untested third party software will void TissueGnostics warranty and every Support or service action required by
34. e Slide button Page 65 of 84 www tissuegnostics com Already approved slides cannot be scanned anymore If you try to scan them the sf Note application will return a dialog box see image bellow If you need to rescan an approved slide you have to create a new project and add the slide ID again Slide 8 patient s name 100 cells Cannot acquire approved slides Figure 95 Results tab already approved slides dialog box 5 8 4 4 Transmission of the result into the hospital network To bring as much comfort as possible into the hospital routine HemoFAXS supports the direct transfer of analysis data into the hospital IT network To initiate the transmission press Transmit button from the Results tab kgia Evaluation Morphology Quis gt Logger Lemani Dimo Sore Sample Summary Classification Result Figure 96 Transmission button Transmission Dialog Page 66 of 84 www tissuegnostics com After pressing the Transmit button the Transmission dialog will appear 7 If you want to transmit slides you have to approve them first If slides were not sf Note approved the transmission cannot be done You will receive a warning message i Select Al Select None Slide 6 100 cells nm Select None Figure 98 Transmission dialog On the left side of the window you have the checkboxes to mark slides for transmission You can select only one or several of them On
35. e patient Page 63 of 84 www tissuegnostics com e Hospital ward the patient belongs to e Diagnosis 2 Classification results this section includes the statistic results of the classification e Absolute effective number of leukocytes for each class e Relative the percentage of leukocytes for each class e Leukocytes overall total number of detected leukocytes e Normoblasts absolute number of detected NRBCs Normoblasts e Not classified absolute number of unclassified leukocytes 3 Morphology 4 Comment the comment entered by the user see Chapter 5 8 4 2 5 Morphology Images see Chapter 5 8 2 9 6 Evaluation Images see Chapter 5 8 2 9 5 8 4 2 Add Comments In the Result section you can add your own comments that will appear on the final report e Goto Comment section and write the desired comment e Press Add Comment button e The comment will appear in the report Acquisition T Evaluston Morph ology lt lt Logger Comment Write comment Classification Result o Class Absolute Relative l Fress button Eosinophi s 1 1 30 Basaphils 1 1 30 EE Lymphocytes 15 19 48 IT Site Name Sample Summary Sample Date a 1i 2011 Sample Mr i0 4441 04 Patient Marne patent s nanny Patient Birthdate g3 11 2011 Ward ward who makes the diagnosis P 3 rl i i Disgnosss patent s diagnosis Monocytes Atypical Lymphocytes C e E men bb de i Ck x
36. eclassified images per slide Add to report The Add to Report option sends the selected cell in the Results Tab to report at the Evaluation Images section 5 8 2 4 Rollover image feature If you want to visualize an enlarged image of a cell keep pressed F3 key and then you will be able to see enlarged images of the cells when hovering with the mouse over the desired images To quit this feature release F3 key Page 49 of 84 www tissuegnostics com Segmented an 1A Figure 72 Rollover image feature 5 8 2 5 Classes of Leukocytes On the right side of the Evaluation tab there is a table with information about the classes of leukocytes These classes are subject to site configuration so a different list could appear for each sf Note configuration It includes the following sections Cell Class Type here are listed all leukocyte classes the buttons can be used for manual classification see Chapter 5 8 2 1 Page 50 of 84 www tissuegnostics com Gel affolle enoe thos Oral JECA Figure 73 Classes of leukocytes e Eosinophils e Banded e Basophils e Metamyelocytes e Lymphocytes e Myelocytes e Monocytes e Promyelocytes e Atypical Lymphocytes e Blasts e Plasmocyte
37. emarks of their respective owners 4 In order to use HemoFAXS application it is essential for the users to have sufficient knowledge of PC and Microsoft Windows operating system usage 5 The information from this document is subject to changes without notice 6 The information contained in this document is the proprietary and exclusive property of TissueGnostics GmbH except as otherwise indicated No part of this document in whole or in part may be reproduced stored transmitted or used for design purposes without the prior written permission of TissueGnostics GmbH 7 The information in this document is provided for informational purposes only 8 TissueGnostics GmbH specifically disclaims all warranties express or limited including but not limited to the implied warranties of merchantability and fitness for a particular purpose except as provided for in a separate software license agreement 9 Copyright 2006 2012 TissueGnostics GmbH All rights reserved 10 Release date of this document 29 February 2012 11 Document version 1 0 Page 4 of 84 www tissuegnostics com Notice regarding symbols and labels on product The following symbols appear on the labels of the product H E M J Q FAXS In vitro diagnostic medical device C MEMATOLOOY ANALYSIS SYSTEM HemoFAXS is a trademark of SN AA103097 TissueGnostics GmbH TissueGnostics GmbH AA Taborstrasse 10 2 8 nssurs GNOSTICS t 04 03 2010 A 1
38. ert is the frame which will be fed with slides and will be inserted into the stage for analysis It will be inserted Figure 112 Insert It will then lock into its position and the user should perform a second check to see if it is really locked The condenser should be checked twice because this task may move the condenser out of center Page 75 of 84 www tissuegnostics com 6 6 Locking the Slide The slide will be locked into its position in the insert by using the insert lock The lock will be opened by pulling back the button below the desired slide position At this point the slide will be moved into its position and the button will be released Please confirm the slide is tightly fixed in its position and if it is lying in a perfect plane If the slide does not lie in a correct plane the acquisition could fail The important contact points are shown in the figure below Figure 113 Important contact points Page 76 of 84 www tissuegnostics com f Troubleshooting 7 1 HemoFAXS does not start The loading process for HemoFAXS could take some time but no longer than one minute If it takes longer please process the following points e Please ensure that the microscope is correctly turned on and attached to the computer If it is not connected to the computer please turn off the computer and the microscope Attach the microscope to the computer Now turn on the microscope and wait until the microscope is ready Now start
39. es originating in the environment every image will be refocused separately The needed cell count for each slide can be adjusted by the user The system will hence try to achieve the targeted number but it is possible to get a different number of cells than expected e g in pathological smears The storage format of the images can be chosen by the customer preferably during installation but we suggest using the JPEG format which gives the best compression while not losing image information Figure 1 HemoFAXS system HemoFAXS consists of four modules 1 Fully automated microscope e 10x Air and 100x Oil Objective e LED Lamp e Condenser Page 10 of 84 www tissuegnostics com Light path filter Phototube Fully automated Z Drive N Fully automated stage For up to 8 slides G9 High resolution color camera Max resolution 2048x1536 gt 15 frames second Automatic white balance 1 2 sensor 4 HemoFAXS Software 3 1 Workflow HemoFAXS is using a color separation method for identification of leukocytes and or other cells The principle workflow is as follows 1 Acquisition of the smear at a low magnification 10x automatic identification of the good working area and collecting the positions of all potential cells 2 Calculating the positions found in the low resolution to positions in the higher resolution this option can be chosen during the installation Acquisition of images of the
40. folder File tolder File Talde File folde File folder File uides File tolde File lolde File tobde File tolder File folder File Talde Fila Talde File folder File folder File folder Folder 201202020008 7201202020001 201202070003 201202020006 7201202020007 Figure 20 Open button Open multiple projects Browsing for desired projects Canceling browsing for projects will return a message box see image bellow Page 23 of 84 www tissuegnostics com Figure 21 Canceling opening projects message box Select Open recent projects option to open previous projects A dropdown list will appear where you can choose the desired project see image bellow Open Open multiple proyects Open recent pregects L Today F FAHemaoFAXS Projects 201 202105 201 202 100001 200 2021090001 pra Yesterday F HemoFAXS Projects 201 20200 201 202 0002 200 202100002 hfnrnj Lert week F HemoFAXS Projects n 3023 05 207 202100003701 202100003 proj Diei d FAHemaFAXS Projects 201 20200201 202100004 701 202100004 hfpra FAFlemoFAXS Projects 20 2021605 201 202100005201 202100065 hfpruj FAHemaFAXS Projects td 202105201 202 00006201 2028000006 fro F AHemeFAXS Projects 201 20 7 106 201 20219000 7 200 202100007 prej FAHemaFAXS Projects 201 20210 201 202 1000068 201 202100008 Foro FAHemoFAXS Projects 201 20 71 05 203 20 21 a 2021000609 hEp raj F HemoFAXS Projects 20 202100 201 20210008 05 201 20210001 0 hf
41. fter selecting a location HemoFAXS will remember it in the dropdown list but you can always choose a new location by using Select location option If you press directly the Capture button HemoFAXS will automatically save your capture at the last remember location and in the last remembered format Capture to C Users Select location Figure 49 Capture feature b Page 38 of 84 www tissuegnostics com 4 Image Acquisition see below Before starting the acquisition please ensure that the Objective turret is not caution between definitive objective positions a definitive objective position is reached when there is an audible and tangible click effect in the objective turret mechanism i Before starting the acquisition please ensure that the condenser is swung and caution adjusted i If the condenser is not located at the right side of the stage please move the stage caution with the joystick to the left side 5 8 1 4 Start the acquisition When it comes to image acquisition this is more than easy in HemoFAXS To start the analysis just press Scan button in the Acquisition section Acquisition Skip current slide Figure 50 Acquisition Scan button After the Scan button is pressed the application will prompt a dialog box All slides that have not been acquired yet will appear in this dialog see image below v Slide 1 v Slide 2 v Slide 3 Slide 4 W
42. hemogram is one of the most important instruments to accurately identify many kinds of diseases in early stages The correct identification and statistical distribution of the leukocyte subclasses in the peripheral blood give information about possible infections morphological changes or in the worst case about different kinds of leukemia 1 1 Intended Use The purpose of this document is to help the user understand how HemoFAXS works It describes HemoFAXS software capabilities and also guides the user through the steps required to easily take advantage of the application in order to obtain best results The document covers the installation of the application system requirements and main features 1 2 Definitions Acronyms and Abbreviations This subsection provides the definitions of all terms acronyms and abbreviations required to properly interpret this document 1 2 1 Definitions Condenser Combination of mirrors and lenses used for the purpose of gathering visible light and directing it onto some object or through a projection lens Insert The insert is the frame into which slides will be set and will be loaded into the stage of the microscope for analysis Koehler A method of illumination used in transmitted or reflected light Illumination microscopy An automatic blood cell count for each slide x axis x is a horizontal axis it moves the stage horizontally from left to right and back y axis y is a horizontal axis
43. it moves the stage horizontally from front to back z axis Z is a vertical axis it moves the stage up and down relative to the objective 1 2 2 Acronyms Objective The optical element that gathers light from the object being observed and focuses the light rays to produce a real image 1 2 3 Abbreviations Page 7 of 84 www tissuegnostics com PC Personal Computer eo 1 3 Conventions In this section you can find listed and explained the conventions used throughout this manual wf Note Note s describes important features or instructions Y TIP Y Tip s highlights features or hints that can help you save time or avoid difficulties 1 CAUTION Caution s warns readers about possible damage to equipment or to data or about potential problems in the outcome of what is intended Italic is used in order to highlight a title and also new or unfamiliar terms usually at their first appearance in the text Bold is used in order to highlight important terms or to mark the names of the features GUI elements throughout the text of this manual the arrow indicates a menu choice For example choose File Save means you have to choose Save from the File menu Page 8 of 84 www tissuegnostics com 2 System requirements 2 1 PC Requirements Minimum requirements e Intel Core 2 Quad 2 66 GHz e 2048 MB Main memory e 100 GB Hard disk e 1 PCle 1x Slot e 1 Firewire 800 Connector e 1USB Conne
44. k performance and the tasks running in the background 5 8 5 Logger Tab Logger tab shows the history available for each project Page 68 of 84 i a 2011 12 12 07 09 19 0202 2011 12 12 07 09 19 0267 2011 12 12 07 09 24 0674 2011 12 12 07 09 24 0951 2011 12 12 07 09 25 0663 2011 12 12 07 09 27 0419 2011 12 12 07 09 28 0871 2011 12 12 07 09 29 0470 2011 12 12 07 09 30 0583 2011 12 12 07 09 32 0382 2011 12 12 07 09 32 0669 2011 12 12 07 09 33 0270 2011 12 12 07 09 33 0774 2011 12 12 07 09 34 0045 2011 12 12 07 09 34 0370 2011 12 12 07 09 34 0653 2011 12 12 07 09 36 0280 2011 12 12 07 09 36 0844 2011 12 12 07 09 37 0507 2011 12 12 07 09 48 0839 2011 12 12 07 09 54 0204 2011 12 12 07 09 55 0381 2011 12 12 07 09 56 0510 2011 12 12 07 09 57 0690 4 Slide acquisition finished Slide acquisition finished Finished Monolayer search monolayer found Locater started Current number of detected leukocytes 7 120 Current number of detected leukocytes 11 120 Current number of detected leukocytes 24 120 Current number of detected leukocytes 41 120 Current number of detected leukocytes 51 120 Current number of detected leukocytes 61 120 Current number of detected leukocytes 80 120 Current number of detected leukocytes 82 120 Current number of detected leukocytes 92 120 Current number of detected leukocytes 94 120 Current number of detected leukocytes 105 120 Current number of detected leukocytes 108 120 Cur
45. lassified 0 00 Add to Report Remove from Report Figure 85 Context menu Remove from report option In the Results tab press the little red x xh from the upper right corner of the desired image y Add to Report Remove from Report options are also available for the images from Note JS the Morphology tab 5 8 3 Morphology Tab The absolute and relative values of leukocytes distribution within the smear are not the only relevant features during the analysis as morphological abnormal features should also be considered Page 58 of 84 www tissuegnostics com Parasite Infestaton Figure 86 Morphology Tab In the Morphology tab a predefined number of images are available for inspection Depending on the setup of your system the number can vary from none to several dozen of images The available morphological features are placed into three different groups available on the Morphology tab one for platelets one for erythrocytes and one for leukocytes Groups and features may vary according to the form of installation you choose To see an image enlarged just keep pressed F3 control from your keyboard and hover over the respective image Page 59 of 84 www tissuegnostics com Figure 87 See enlarged image 5 8 3 1 Select a morphology feature To select an observed morphologic abnormality click on the appropriate platelet erythrocyte or leukocyte button The selected button remains in the dow
46. mer Flip this parameter is used to flip the captured image You can use this parameter to correct the orientation of the image if the left right or top down of the camera are different that those of the stage This parameter is generally adjusted when the system is installed The FOV calibration feature is able to automatically set this parameter to its correct value Size this is the resolution in pixels of the captured images Pixel Format the format used when transferring images from the camera only experts in imaging should change the settings Rotation this parameter is used to rotate the captured image Use this when the camera is placed in a 90 180 270 degrees position in relation to the stage Resolution this parameter is used to adjust the amount of detail in an image Save settings for further use The Save button will save the current settings in a local folder Use the Load button to load a previously saved set of settings After modifying any settings from PixeLINK Camera Settings dialog click Apply button to accept the settings or Cancel button to reject them Capture To capture an image you have to press Select location option from the dropdown list then in the Save as browser that appears choose e alocation for the file to be saved e aname for the file e the format of the file bmp jpg jpeg png tif tiff Capture to no path selected Select location Figure 48 Capture feature a A
47. n position which indicates that the abnormality has been selected All selected features will be included in the report and saved with the project file 5 8 3 2 Select a morphology grade of a feature To select a morphology grade of a feature right click and hold pressed on the appropriate platelet erythrocyte or leukocyte button A dropdown box will appear from where you can select a morphology grade Trombocytes Figure 88 Selecting a morphology grade of a feature After selecting a grade the feature will turn in the appropriate color of that grade Page 60 of 84 www tissuegnostics com 5 8 3 3 Contextual menu for morphology images If you right click on any image in the Morphology tab a menu like in the images below will appear ue e9 ee Se e 96 9 3e 299 61 i i 4 s 4 T i 7 1 r Ra 7 ia i amp d E TL mr 4 J VW pO ar tA p iP 4 i P a dd a CENE E x T k 3 LT a4 i mt LA b i E oe i k j r E Jj x j n pr 1 ia i ec owa SEI EE Gotolmage Td 1 Go to Cell L E a rapes bti gt Mn u Export Image jJ Export Image is ara n a P EH a eg sie m S Add Comment Add Comment i Comment Tag History d Comment Tag History b Post Processing Post Processing Add to Report Add to Report Remove from Report Remove from Report Figure 89 Morphology Contextual menu The following options are available e Goto Image Go
48. nd cells in the 100x phase seesseeeeeeeenneeemm 78 7 4 HemoFAXS does not find a focus plane 100x cece cceeccceeeeeeeeeeeeeeeeeeeaeeeseeeeeseeeesseueeeaeeeseeeeessaeessaaees 78 7 5 HemoFAXS does not classify automatically 2 0 0 0 ccccccccceccceeeeceeeeceeeeseeeese esse eeseueeseeeeseeeseeeesaeeesueeaeeeeaes 79 7O Mages are I0 o PT ER 79 ld Images are 9 6 Cierra eee eee 79 lO Colors are nol CONGO eserinin EE AAEE ee er ee a i 80 O RETO O e e ee E E E E E R 82 w BDO mn S O PERROS 83 10 Document Quality PASSUNNC Coscia cars cites mncrartadseanaienndedensc vars duinanidch 84 Page 3 of 84 www tissuegnostics com Disclaimers 1 HemoFAXS does not give final diagnostics results and it is mandatory that the clinical expert re evaluates all images There is the possibility that the individual samples do not contain enough cells for a clear diagnosis The results of the analysis are purely statistical values Users must reevaluate images and likelihood of the Statistical data Pure interpretation of statistical data is a high risk 2 The product should be used only after training performed by TissueGnostics or authorized distributors of TissueGnostics A list of authorized distributors is available here http www tissuegnostics com index php load xml en home company distributors xml amp lang en 3 The names of actual companies and products mentioned herein may be the trad
49. olbar of HemoFAXS Page 20 of 84 www tissuegnostics com Figure 14 New Project button 5 2 2 Set the storage location In the New Project dialog that appears set the directory where HemoFAXS will store the finished analysis Browse for the desired location by using the Browse button ea then press OK button Select the storage folder F Projects HemoFAXxS Figure 15 Storing New Project When creating a New Project inside the chosen directory a folder with current data is s f Note created that contains saved slides each in its own folder Before creating a New Project ensure that you have enough free space on the drive in s f Note order to save the project If the free space on the drive you have chosen to save the projects is too low you will receive the following warning dialogs Figure 16 Storing New Project Page 21 of 84 www tissuegnostics com A Available hard disk space is low Figure 17 Storing New Project FE If during the acquisition process HemoFAXS runs out of free space the projects will not sf Note be saved properly 5 9 Open a project To open a project use Open button located on the main toolbar of the application Open multiple projects Open recent projects Figure 18 Open project button HemoFAXS provides three types of opening Select Open option to open a single project The Open dialog will appear where you can browse for the desired project
50. ou will open during a HemoFAXS session remain listed in the Project dropdown list so you can easily access them by a single click on the project s name from the list After closing and reopening the application the Project dropdown list will clear and you will have to use the Open button in order to load your projects In HemoFAXS for each slide a new project will be added Project 3 Figure Figure 27 Projects dropdown list 5 4 Save and close a project HemoFAXS automatically saves after each slide and before closing as well as before the creation of a new project To save a project press Save button in the main toolbar of the application Figure 28 Save button The Close feature has two options Page 26 of 84 www tissuegnostics com Close Close All projects Figure 29 Close options Close will close currently used project Close all projects will close all loaded projects Do you really want to close this project o Do you really want to close all projects s Figure 30 Close HemoFAXS message boxes 9 9 Print a report Even in days of complete automation and electronically reporting there is still a need for reports printed on paper Therefore HemoFAXS also offers the ability to print a report To print a report go to the main toolbar of the application and press Print button Figure 31 Print button The Print dialog will appear Select the printer set the printing p
51. proj FAHemaFAXS Projects 201 202000200 20219001 1 201 202 10001 1 Af pray FAHemoFAXS Projects 201 202105 20120210001 2 201 20210001 2 hFproj FAHemoFAXS Projects 201 2022 05 200 202001 25204 202 0600 3 fpa FAHanmaFAXS Projects 3071 05 201 20210001 4 201 20210001 4 hif pro FAHemaoFAXS Projects 201 202105 201202 10001 5 200 207109001 5 hfpraj HemoFAXS Projects 202300 200 2021 0008 8 201 200210061 8 HrEnrnj F HemoPAXS Projecte AM 302 00 200 20210061 6 20210001 7 fifproj FAHemoFAXS Projects 20 202100 201 202100018201 proj FAFHemoFAXS Projects 201 202105201 20210001 55 201 20210001 B hFprnj FAHemoFAXS Projects 201202108201 202100020 201 202100020 hfproj FAHemaeFAXS Projects 2021 05 201 202190071201 202100071 prej FAHemaoFAXS Projects 201 2021605 201 202 1000 22201 202130027 proj FAHemaoFAXS Projects 201 2071 05 200 20 21000237200 202100073 HEprni Figure 22 Open button Open recent projects When opening multiple projects a progress bar will appear This means that opening e the project will take several seconds When opening multiple projects selecting only one folder will open all existing sf Note projects in that folder Page 24 of 84 www tissuegnostics com Opening Project Setting slide to results page Figure 23 Progress bar for opening projects rr When opening a single project but also when opening multiple projects two sf Note situations can occur the selected files are already opened
52. references and press Print button Page 27 of 84 www tissuegnostics com Select Printer aa Samsung ML 2250 Series 4 Status E Print to file Location Comment Page Range All Number of copies 1 E Selection Current Page C Pages 1 4 Collate Enter either a single page number or a single page range For example 5 12 Figure 32 Print report dialog An x The Print button will only print the final Report of the analysis ote 9 6 Find Slide option Find Slide is a HemoFAXS feature that helps the user manage the information from various slides and easily find a certain detail within large amount of data CERTE pui o jmenwewe om D o5 SSO Hee Ws Gee amp Gmel Figure 33 Find button Press Find button from the main toolbar in order to open Find Slide dialog Page 28 of 84 Www tissuegnostics com f HemoFAXS Find Sli Find where Search Options Sample Nr E Match case Patient Name E Find whole words only Ward v All Search results Sample Nr Patient Name Ward Diagnosis File Path 0000000100 PF Projects HemoF AXS HeF 2 0 V21 201112120001 20111212000 1 hfproj 0004565450 F Projects HemoFAXS HeF 2 0 V21 201112120003 201112120003 hfproj 0000121000 F Projects HemoFAXS HeF 2 0 V21 201112120002 201112120002 hfproj Figure 34 Find Slide dialog To be able to perform the search operation use the available filters Find Where
53. rent number of detected leukocytes 110 120 Current number of detected leukocytes 115 120 Current number of detected leukocytes 116 120 Current number of detected leukocytes 123 120 Oil spreading started Aquire started Acquired leukocyte 0 100 Acquired leukocyte 0 100 Acquired leukocyte 0 100 Acquired leukocyte 0 100 Figure 100 Logger tab The upper section of the tab shows a list with all available projects For each project the following information is available Slide number Status acquired not acquired etc www tissuegnostics com The lower section of the tab gives a history for the project selected above The following information is listed Date and hour for each history item Severity Message the history item is described e g Oil spreading started Acquired leukocyte 1 100 etc Page 69 of 84 www tissuegnostics com 6 Microscope Maintenance and Operation 6 1 Cleaning the objectives To keep HemoFAXS fully functional both objectives have to be maintained and cleaned after each use especially if using oil 6 1 1 Cleaning the 10x objective The 10x objective can be easily contaminated if it comes in contact with the oil poured on the slide causing difficulties in finding cells or detecting the monolayer To overcome this the objective should be cleaned daily with a cotton swab or a lint free cotton cloth and weekly by using 70 EtOH Ethanol Using a cotton sw
54. s e Segmented e Normoblasts e Not classified Viewed if the checkbox is marked the respective class has been visualized Count the number of leukocytes included in the respective class If all cells from a certain class were visualized the values in the Count section will Y A ote appear with a green color If not the values in the Count section will appear with a red color Percent the percent of leukocytes included in the respective class Page 51 of 84 www tissuegnostics com Leukocytes overall the total number and total percentage of leukocytes 5 8 2 6 Profiles In HemoFAXS you can use profiles in order to save the number of columns and their values The profile in use is displayed in the Active profile field If pressing the arrow a dropdown list including all the available profiles will be shown Figure 74 Profiles To add a new profile press Add profile button and in the dialog that opens write desired name then press OK in order to effectively save the new profile Name of the profile Demo Figure 75 Adding new profiles In order to add a new profile all columns in the Evaluation Tab must be selected Otherwise a message box will appear Figure 76 Add new profile message box To delete existing profile press Delete profile button If you want to delete more profiles press Delete profile button until all desired profiles are erased Page 52 of 84 www tissuegno
55. slide button During the analysis you can press this button to skip the current slide and advance to the next slide 5 8 1 7 Finish scanning If this option is selected a dialog box will appear The user will be able to scan only unacquired slides that appear as checked in the dialog box prompted by the application Page 40 of 84 www tissuegnostics com v Slide v slide v Slide 7 fa Ca Lal fj v Slide 4 W Slide 5 0 v Slide 6 at Ct e E Figure 55 Acquisition controls Finish scanning dialog box 5 8 1 8 Scan all slides from This option will allow you to scan all existing slides from the current project To select this feature press Scan all slides from option from the Scan button A dialog box will be prompted where all slides to be acquired appear as checked see image below PETI Hu r n qe ener FPE 694 am s ides from Projec Project 1 v Slide v Slide v Slide Lal pP je v Slide 4 g Slide 5 R Slide 6 W Slide 7 w Slide 8 LA Da 2 G 23 G 623 623 63 4 Figure 56 Acquisition controls Scan all slides from option 5 8 1 9 Select slides to scan Repeating the analysis for one or several slides may sometimes be necessary e After stopping the analysis e After a break you can acquire the remaining slides e Ifthe analysis of one slide is not trustable or if the images are blurred you can easily repeat the analysis scanned yet the
56. stics com Figure 77 Deleting previously created profile 5 8 2 7 Scroll bar In the lower left corner of the application you can find a checkbox called One scrollbar for all columns e fthe checkbox is not checked each column will have its own scroll bar Page 53 of 84 www tissuegnostics com Figure 78 Separate scroll bars e If the checkbox is not checked each column will have its own scroll bar Page 54 of 84 www tissuegnostics com Figure 79 One scroll bar for all columns e fthe checkbox is ticked all columns will have a single common scroll bar 5 8 2 8 Columns display In the lower part of the application you can find a column display instrument CoM Figure 80 Columns display You can choose to have displayed up to ten columns just press the corresponding rectangle like in the image below Page 55 of 84 www tissuegnostics com Figure 81 Columns display examples If no cell is selected by pressing the corresponding class name that class will be displayed in one column 5 8 2 9 Adding images to Report You can add any image from the evaluation to the final Report by selecting desired image then choosing from the dropdown menu Add to Report option All the images added to the Report will be marked with a little R inside a square Rh Page 56 of
57. the client in order to restore any of TissueGnostics damaged instruments will be billed to the customer e Please contact TissueGnostics about any third party software you want to install on your system We will advise you free of cost whether the software can be installed according to our knowledge If testing will prove necessary TissueGnostics will declare so and if you wish to have such testing done you will be billed for the cost Notice regarding relocating cells with the Go to Cell function e The relocation of cells works only if the tray was not removed from the stage and the system was not recalibrated in the meantime Notice regarding scanning preparations e Before starting the acquisition please ensure that the Objective turret is not between definitive objective positions a definitive objective position is reached when there is an audible and tangible click effect in the objective turret mechanism e Before starting the acquisition please ensure that the condenser is swung and adjusted e Position the stage in such a way that the Condenser is located at its right end if this no so please move the stage with the joystick to the left side Page 6 of 84 www tissuegnostics com 1 Introduction HemoFAXS is an automated cell locating device which automatically locates leukocytes within peripheral blood smears and spins and presents images of the human blood at high resolution The differential blood analysis
58. the right side you have the Select All and Select None buttons Those are responsible for selecting all available slides or unselecting them respectively On the lower right you have the Cancel and the Transmit buttons They are used for canceling the transmission or execute it respectively Between the checkboxes on the left and the buttons on the right you have a small information list which shows you how many of the leukocytes were found on which slide as well as their id numbers to identify them correctly Additionally you have a project selection drop down box on the top of the window Here you can specify from which actually loaded project you want to transmit results Page 67 of 84 www tissuegnostics com Select slides To select a slide for transmission you have to tick the checkbox besides the wanted slide Repeat the process for all wanted slides if you decide that one of the slides should not be transmitted you can easily deselect it be clicking on the checkbox again z slide 1 0 cells Slide 2 Q 0 cells Slide 3 0 cells Select None Slide 4 0 cells Slide 5 0 cells Slide 6 0 cells Slide 7 0 0 cells Slide 8 0 cells Figure 99 Transmission dialog selection of slides Transmission Please check all selected slides before submitting it into the hospital IT network Next press the Transmit button and wait The transmission can take up to several seconds depending on the networ
59. ton saves a project to your storage media including all results and comments see Chapter 0 Print this button prints the result of the actual selected smear on a printer see Chapter 5 5 Find this feature helps you manage the slides see Chapter 5 6 Lock press this button to lock the application Exit it closes HemoFAXS and ends every running analysis 5 1 1 Acquisition Figure 9 Acquisition Tab The Acquisition tab contains the following sections see image above Section for project information 1 Number of slides dropdown list to change the number of smears to analyze 2 Maximum number of cells per slide spinner list for the number of cells to count per smear 3 Main window for the live preview 4 Camera controls 5 Image acquisition section 6 Magnification settings 7 Page 16 of 84 www tissuegnostics com 5 1 2 Evaluation O jojoji le ojo z g o Li A alele Figure 10 Evaluation Tab The Evaluation tab contains the following sections see image above e Current project control 1 e Current slide control 2 e Zoom control 3 e Leukocyte overview window with leukocyte subclass columns 4 e Leukocyte manual classification buttons 5 e Leukocyte counts 6 e Profile management 7 e Columns number control 8
60. www tissuegnostics com HemoFAXS 2 0 User Manual Page 1 of 84 www tissuegnostics com Table of Contents Ms WO CIC OU RR 7 ie 1 21g 19 DR E ree en no renee ee 7 1 2 Definitions Acronyms and Abbreviations lssessssssesssssssessseeeeennnee nennen nnne nnn nenas nna nna sn sa nsa esas 7 1 2 1 Bio MR ie T 1 2 2 ACTON eaa E E M NaDUM NI RU NMUUE 7 1 2 3 gere een en ee eet er ee E ae ee 7 Woe Go iuo nee nage ne ce ede eto cee ee ee eee eee 8 2 VS LORM OCI OTN CM MR 9 75 MEE POREO RC REOR en eee eee eee 9 MEE UU N a ee ee ee ee ee eee eee eee eee 10 C PEE Ted NER 11 4 Bero a rP P A E E E E 12 9 E Sa E AC E E E E PT E E Gian ave E A E E A E E E E EE 15 s UUD i ee e E EE E E E E E E E 15 5 1 1 ACUI O sere deie E EEE I AEE E EEEE EAEE EE E E 16 5 1 2 BAN AO oiea e de E EE A EE E E EEE E E conte 17 5 1 3 KAE e AEE S h E E E A A E ET A E E A EE E EE EE E AE m 18 5 1 4 ROSU tee E ER EE EEE EEEE E E A E E AE E E 19 5 1 5 LOOG e E O ER ne taste EEE EEE EEEN E S E EN E E A E EE EES 20 Fer NEW DOO arrr steiner lc acct EE EE E EEEE EEE N E TEENE E E E EEE E EE 20 5 2 1 Create a new Meie em
61. zontal E vertical Pixel Format Resolution BAYER 16 GREG 1600 x 1200 Load Settings Save settings Quickly Figure 47 PixeLINK Camera Settings dialog Parameters This PixeLINK Camera Settings dialog includes a set of parameters that help refine the image Exposure Time The amount of time available to the sensor for collecting light to form an image Increase this parameter when the light intensity is low Saturation represents the purity or strength of a color due to absence of black white or gray Adjusting color saturation will affect how intense the tones of the color are in your image Use this in order to enhance colors on tissues with faded colors Gamma adjusts the contrast of the image You can use this to highlight the differences between the light and dark areas or in order to minimize these differences White Balance this parameter adjusts the intensity of the Red Green and Blue colors in order to render a neutral color correctly white is usually used as a reference You can press Auto to autobalance the colors When the Page 37 of 84 www tissuegnostics com transmitted light is not white you can use this parameter in order to correct the hue of the light in order to obtain the reference white light Gain artificially adjusts the intensity of pixels by software multiplication of pixel values Color Temperature this parameter is similar to white balance making the picture look colder or war

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