Home

EmbryoViewer EmbryoViewer ryoViewer™

1. Slides J Slide and embryo details 2nd treatment gt Treatment ID if a patient has several treatments these are shown ist treatment Slide ID if several slides belong to the same patient these are shown v Shows time lapse films of embryos from the specific slide Shows embryos from the specific slide in a timeline view Y V Detailed view of embryos for annotation of e g cleavage times Running conditions for the specific slide e g incubation temperature and gas concentration Exports video sequences and single images vv v Generates report sheets laboratory data instrument data patient information Database Database of all acquired data View All Slides gt Lists all slides including data on e g fertilization time primary outcome data and instrument QC status Instrument gt Lists all slides and primary running conditions for each slide Settings gt Backup and upload of data Settings gt Backup of data and upload of data to Unisense FertiliTech A S Page 7 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 2 2 Association between different ID s Several ID s are used in EmbryoScope and EmbryoViewer data Below is a description of the different ID levels and a figure showing an overview of the association between the patient ID treatment ID slide ID
2. Oocytes Aspirated 12 X Total FSH Dose IU Sibling Embryos in Standard Incubator LH Supplement No X Comment Slide ID D2010 01 12_S0143 I006 Fertilization Slide Treatment ID Fertilization Date Treatment 01 2009 05 11 Slide Description Fertilization Time hh mm Pre equilibrated 18 h 11 15 ES Fertilization Method ICSI 2 Embryos Transferred Second Medium Brand Unknown Media Change oe s Comment Fetal Heart Beat 2 Live Born Babies EE o oou 4u0NWN Container 1 5 7 straw 1 Container 1 5 6 straw 2 Container 1 5 6 straw 2 This page shows three boxes the top box where patient information can be specified or is loaded via connection to the EmbryoScope the middle box where treatment information and outcome data can be specified and the bottom box where slide information is shown 5 2 2 Patient details Information in the patient details box is e Patient ID and name e Birth year and month Page 19 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 e Body mass index BMI e Basal serum FSH e Patient diagnosis e Comments related to the patient All treatments associated with the patient are listed in the panel on the right side of the Patient Details box The highlighted treatment is the treatment shown in the middle box Clicking on different treatments in the All Treatme
3. Dynan Score Z25cwe Merpholegcsi Grade Teme Stage Vale astorer Sie P Cramer Vultrudeabon 1 D cels out of 4 cels 9 Even Page 10 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 2 4 4 Embryo development at specific time points Click the button to display the embryos within the specific slide at specified time points The morphological grade can be typed in at the top of each embryo timeline view The morphological grade is also shown in the Annotate page 3 B Wel 5 Morphological Grade m viet 4 Mar phoig ai Gr ard z Y S3 5 a Q w N PEPPE eae BEPE DADER Q929 Q PEPPE JCOEOEES 2 4 5 Grading embryos The time lapse inspection and annotation tools assist the embryologist in selecting the best embryos for transfer and freeze The embryo grade or score can be saved using the boxes shown below For explanation of the Dynamic Score Z Score and Morphological Grade see section 6 3 4 D ynamic Score Z Score Morph Grade Page 11 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 3 Introduction 3 1 EmbryoViewer introduction The purpose of the EmbryoViewer workstation is to assist the embryologist in selecting the best embryos The EmbryoViewer does not perform any diagnostics but only shows data from the EmbryoScope and dat
4. These logs are primarily used for trouble shooting if any problems occur with the EmbryoScope Summary Warnings Log Other Date Time Log 05 05 2010 05 51 21 Slide 0 Well 5 x pos 133 y pos 3 05 05 2010 05 51 32 Slide 0 Well 6 x pos 128 y pos 2 05 05 2010 06 05 27 Slide 0 Well 0 x pos 140 y pos 6 05 05 2010 06 05 38 Slide 0 Well 1 x pos 136 y pos 7 05 05 2010 06 05 49 Slide 0 Well 2 x pos 138 y pos 2 05 05 2010 06 06 00 Slide 0 Well 3 x pos 148 y pos 7 05 05 2010 06 06 11 Slide 0 Well 4 x pos 138 y pos 8 05 05 2010 06 06 21 Slide 0 Well 5 x pos 135 y pos 2 05 05 2010 06 06 32 Slide 0 Well 6 x pos 124 y pos 4 FanAAAAAAAAAAAAAAAAAAAAAAAAARAAAAAAARAAAAAAAAAAAAAAAAAAAAARAAAAAAAAAASAAAAAARARAAAAAAAAAASARAARAAAAAAAAAAAASARAAAAAAAAAAARAAAAAAAAAA n5 n5 2n1n n amp 6 20n 2R Slide n Well N v nns 141 v nns 6 Logging parameter Default x Page 41 Unisense FertiliTech A S EmbryoViewer 3 0 6 4 7 The Other sheet User manual v3 0 The sheet named other lists a table of average min max and standard deviations of several running conditions such as temperature within the EmbryoScope and current use of different parts of the EmbryoScope The parameters are also shown graphically The parameters can be checked unchecked in the graph legend The zoom function also functions in this graph Summary Warnings Log Other Measurement Average Min Max Std Dev Backboard Temp
5. 253 New files 3 Modified files 2010 07 31 02 00 Total backup files 253 New files 3 Modified files 2010 07 29 02 00 Total backup files 253 New files 3 Modified files 2010 07 28 02 00 Total backup files 253 New files 3 Modified files 2010 07 27 02 00 Total backup files 253 New files 8 Modified files 2010 07 22 02 47 Total backup files 248 New files 248 Modified files 0 2010 07 21 10 36 Total backup files 248 New files 248 Modified files 0 2010 07 21 02 42 Total backup files 248 New files 223 Modified files 0 2010 07 20 02 00 Total backup files 29 New files 4 Modified files 0 2010 07 19 02 00 Total backup files 28 New files 3 Modified files 0 2010 07 18 02 00 Total backup files 28 New files 3 Modified files 0 2010 07 17 02 00 Total backup files 28 New files 3 Modified files 0 2010 07 16 02 00 Total backup files 28 New files 4 Modified files 0 2010 07 15 02 00 Total backup files 27 New files 3 Modified files 0 Force FTP Connection to Unisense Fertili Tech carece pe Eg 2010 08 06 15 00 Annotation SCW CK92602T4PD 20100806 1500 pdb V Upload Well Annotations to Unisense FertiliTech 2010 08 06 14 59 Annotation SCW CK92602T4PD 20100806 1459 pdb 2010 08 06 14 58 Annotation SCW CK92602T4PD 20100806 1458 pdb 2010 08 06 14 57 Annotation SCW CK92602T4PD 20100806 1457 pdb E A 2010 08 06 14 57 D2010 08 06_50091_1102 pdb Upload of Patient Information to Unisense FertiiiTech 2010 08
6. 06 14 57 D2010 08 06_S0089_1102 pdb 2010 08 06 14 57 D2010 08 06 S0088 1102 pdb NO Upload 2010 08 06 14 57 D2010 08 06 50087 1102 pdb 2010 08 06 14 57 D2010 08 06 S0086 1102 pdb AT 2010 08 06 14 57 D2010 08 06 50085 1102 pdb Patient Information WITHOUT Patient ID 2010 08 06 14 57 D2010 08 06_S0084_1102 pdb f 2010 08 06 14 57 D2010 08 06_50083_1102 pdb Patient Information WITH Patient ID 2010 08 06 14 57 D2010 08 05_50082_1102 pdb 2010 08 06 14 57 D2010 08 05_50081_1102 pdb 2010 08 06 14 57 Annotation SCW CK92602T4PD 20100806 1457 pdb 2010 08 05 20 16 04 Annotation SCW CK92602T4PD 20100805 2016 pdb 2010 08 05 20 05 32 Annotation SCW CK92602T4PD 20100805 2005 pdb 2010 08 05 20 04 51 Annotation SCW CK92602T4PD 20100805 2004 pdb 2010 08 05 20 02 49 Annotation SCW CK92602T4PD 20100805 2002 pdb 2010 08 05 19 54 29 Annotation SCW CK92602T4PD 20100805 1954 pdb 2010 08 05 18 55 Annotation SCW CK92602T4PD 20100805 1855 pdb 2010 08 05 18 54 Annotation SCW CK92602T4PD 20100805 1854 pdb 2010 08 05 18 52 Annotation SCW CK92602T4PD 20100805 1852 pdb 2010 08 05 18 49 Annotation SCW CK92602T4PD 20100805 1849 pdb 2010 08 05 18 48 D2010 08 05 50078 1102 pdb 2010 08 05 18 48 D2010 08 05 50077 1102 pdb 2010 08 05 18 48 D2010 08 05 50076 1102 pdb Force Program version 3 0 0 2 F Show Slide for Data NOTE Patient Names will NEVER be Uploaded Page 54 Unisense FertiliTech A S EmbryoViewe
7. 1227 2 pnmum 0 10 10 20 D 20 50 50 100 39 7 3 40 2 4 540 5 Multinudeation 0 cell s out of 2 cells 545 6 557 7 Naked Irregular Division 57 5 8 E Ovoid Fragmentation Blastomere Size 337 2 0 10 Granular 9 Even Uneven Zona pelucida defect Comment Contrast Well 4 Previous Next WHR Soe HE Ga Page 34 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 Well 2 ID 2 Well 6 j o 50 52 7h os aud NM li Cells Visible nudei a o a o Visible nudei Dynamic Score Z Score Morphological Grade Dynamic Score Z Score Morphological Grade Time Stage Value a Time Stage Value pl normal ie 5N ENS O Pronudei ascia ids PN Q 2N 3N 4N 297 2 IN N ON PN Blastomer Size 25 3 wrest agmentation Fragmentation Fragmentation iee t unen 0 10 10 20 20 50 50 100 mo 8 0 10 10 20 20 50 50 100 0 10 10 20 t 47 7 4 Even 56 7 5 Division Multinudeation 1 cel s out of 4 cells 58 2 6 Multinudeation 0 cel s out of 4cells Multinudeation 0 150 5 2 60 5 7 V Naked V Irregular Division i Naked Irregular Division Naked 443 0 3 65 7 iles aa s Ovoid Blastomere Si ze Ovoid Blastomere Size Ovoid e sso 5 V Granular Ee
8. 3 0 User manual v3 0 6 4 4 Summary sheet Running conditions for incubation temperature and gas conditions average min max and standard deviation Summary Warnings Log Other Variable unit__ Average Min Max StdDev Temperature C 37 05 37 04 37 07 0 01 CO2 Concentration 96 6 03 5 74 6 06 0 02 CO2 Flow Wh 1 47 0 76 6 15 0 40 CO2 Pressure bar 0 57 0 52 0 59 0 01 O2 Concentration 96 5 00 4 99 5 51 0 03 N2 Flow Wh 8 82 3 43 36 28 3 30 N2 Pressure bar 0 44 0 35 0 47 0 02 6 4 5 Warnings sheet The warning sheet lists for example incubator warnings alarms lost connection between the EmbryoScope and the EmbryoViewer door openings Summary Warnings Log Other Date Time Warning 05 05 2010 07 43 24 Door closed 05 05 2010 07 43 27 Door opened 6 4 6 The log sheet The log sheet lists a number of detailed parameters of instrument functions There are a number of parameters that are logged during the incubation The parameters are categorized in the following groups which are available in a drop down menu 1 Default Information about timing of slide loading position of each image etc 2 Description Information about embryo description slide start end program version etc 3 Camera Information about where the best focal plane was found 4 Incubator settings O2 CO2 and temperature settings 5 Instrument parameters Information about all instrument specific parameters calibrated during reset
9. 5 310 0 077 Approved D2010 05 25 50130 1007 7 130 2456 2010 05 25 14 06 37 019 5 351 0 145 4 573 2 373 Approved D2010 05 25 501311007 7 131 5673 8954 2010 05 25 14 07 37 136 3 963 3 870 8 665 24 561 Approved D2010 05 25 01321007 7 132 4562 8654 2010 05 25 14 08 37 136 3 963 3 870 8 665 24 561 Approved D2010 05 25 50133 1007 7 133 2457 8754 2010 05 25 14 25 37 155 3 731 4 508 8 665 24 561 Approved D2010 05 25 0134 1007 7 134 4631 9535 2010 05 25 14 26 37 155 3 731 4 508 8 665 24 561 Approved D2010 05 25 50135 1007 p e 135 4710 9271 2010 05 25 14 27 37 156 3 639 4 808 8 665 24 561 Approved Average 37 05 7 98 20 86 4 75 1 84 T Page 52 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 7 2 2 Average incubation conditions for all slides The average incubation temperature gas concentration and flow for all several or a specific instrument is calculated at the bottom of the table The average incubation conditions for a specific instrument are calculated by selecting the instrument in the top row instrument All other parameters can be sorted in ascending or descending order by clicking on the top row D2010 08 06_S50083_1102 102 83 P0014 2010 08 06 10 28 37 047 4 243 5 050 6 458 14 162 D2010 08 06 50084 1102 102 84 P0015 2010 08 06 10 29 37 047 4 243 5 050 6 458 14 162 D2010 08 06 50085 1102 102 85 P0016 2010 08 06 10 35 37 049 1 000 1 000 6 732 16 011 D2010 08 06 50086 1102 102 86 P0016
10. scroll wheel on the mouse or using the up and down arrows on the keyboard 6 2 5 Magnification of images in Timeline An image can be magnified by double clicking on the image The image shown in the magnifying frame can be changed to any other image by double clicking on the other image In the magnified view the scroll wheel and the up and down arrows can be used to change the focal planes Monday 31 May 2010 21 37 E 40 M T sshown 10 v Update Don t show discarded Save a Page 33 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 6 2 6 Morphological grade A morphological grade can be given in the box in the header and will also be displayed in the sheet Annotate Well 1 Morphological Grade 6 2 7 Shortcut Double clicking on one of the headers of the embryo timelines opens the Annotation sheet with the chosen embryo 6 3 Annotate The button becomes active when one two or three embryos have been selected on either the View Slide or Timeline page Detailed annotations of the embryos can be done on the Annotate page Monday 31 May 2010 21 45 f3 Well 10 ID 8 Time Stage Value Dynamic Score Z Score Morphological Grade 18 8 1 true 2 Blastomer Size Pronudei 33 2 Even 1PN 2PN 3PN 4PN Division L
11. the green bar Viewing time lapse right and left arrows on the keyboard Tapping the right arrow steps the time lapse forwards left arrow steps the time lapse backwards Focal plane Images are taken in different focal planes To the right of the image a bar with tick marks indicates this stack of images The blue dot indicates the focal plane of the shown image By moving the blue dot up and down the relevant image will be displayed Just clicking above or below the dot displays the image plane just above or below the presently shown If the cursor is placed over the image arrow up or down moves the focal plane up or down respectively The scroll wheel on the mouse can also be used to scroll up or down through the images from different planes Page 25 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 6 1 3 Cell divisions When a cell division is observed it can be annotated by clicking the plus or minus signs above and below the white space in the upper left corner of the box until the relevant number of cells are displayed A black vertical line appears in the division chart to indicate the cell division Number of cells Alternatively the annotation can be done by clicking on the white space which opens a drop down menu with the following options 1 2 3 4 5 6 7 8 9 for the number of cells M morula B blastocyst EB expanded blastocyst HB hatching blastocyst for further developme
12. with patient ID and patient name can be printed for the slide s When the slide s associated to the patient is created on the EmbryoScope the EmbryoScope shows a list in a drop down menu of patient name s and patient ID s that have previously been created in either the EmbryoScope or the EmbryoViewer For coupling of treatment ID with slide ID see section 5 2 11 NOTE It is essential that the correct patient ID is chosen on the EmbryoScope if a new slide is added to an existing patient Page 18 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 5 2 Patient details Patient Details This part of the EmbryoViewer provides the user with patient information treatment and slide information 5 2 1 Detailed patient and treatment information Friday 13 August 2010 12 34 Patient Details Patient ID Patient Comments All Treatments 11234 _5678 E Treatment 02 Patient Name Ann J Donaldson Birth Year Birth Month 1972 X 6 BMI Basal Serum FSH IU I 4 s 25 0 H a Diagnosis Print Label foo Treatment Treatment 01 Medication Oocyte Culture Outcome Medication Protocol Oocyte Source Media Type HCG Test Abortion Slide s in this treatment Short ist X Aut us Y Positive x D2010 04 07 50170 I006 con plago No z Medication Brand Oocyte History First Medium Brand Gestational Sacs Abortion Comment Unknown X Fresh X Unknown 2 X Triggering HCG
13. 1 Human Clinical Select Slide Data CO m gt Computer BOOTCAMP C Users Embryo Desktop ES D database newfiles Organize v New folder z Xt Favori n Name Date modified avorites RE Desktop d Downloads Recent Places D2009 12 21 50134 I011 pdb 17 03 2010 13 32 D2009 12 23 50139 I011 pdb 17 03 2010 13 39 D2010 01 11 50153 I011 pdb 17 03 2010 13 34 Libraries View only clinical slides Anne Donaldson d B Videos 1M Computer amp BOOTCAMP C P10203270 cs Macintosh HD E Ell CD Drive F 3Co cx 128GB SSD USB 34 umm micron aX database mic 2 unisenseS mic Wt beh A mirraro File name D2010 01 11 50153 I011 pdb D2009 12 21 50134 I011 pdb D2009 12 23 50139 I011 pdb Import Delete Export A pop up box appears while slide data is imported Importing D2009 12 21 S0134 I011 pdb After import the file with the slide data is saved in the database folder and a dialog box asks if the slide data should be deleted from the folder from where it was imported If the slide is already present in the database a pop up box appears asking for overwriting the existing slide data or not importing the slide Page 51 Unisense FertiliTech A S EmbryoViewer 3 0 Question A Delete slide data Data were succesfully imported Delete original file 7 1 5 Deleting a slide C
14. 1 we 0 0 Human Clinical D2009 12 15 50130 1011 P10203110 Linda Brown 1001010 2009 12 15 14 00 0 78 69 76 11 130 3 Annotated 2 W2W6 1 1 Human Clinical D2009 12 15 1040 1004 P10203120 Barbara White 1001011 2009 12 1414 00 19 90 11708 4 1040 157 Annotated 2 W6 W9 0 0 Human Clinical D2009 12 16 51044 1004 10203130 Jennifer Redford 1001013 2009 12 18 14 00 21 97 93 08 4 1044 205 Annotated 2 W6 W7 0 0 Human Clinical D2009 12 23 0139 1011 P10203150 Pamela Peterson 1001015 2009 12 23 16 00 0 15 65 35 11 139 259 Annotated 1 we 0 0 Human Clinical D2009 12 28 S0145 1011 P10203160 Marie Spingfield 1001016 2009 12 28 14 00 0 62 139 57 11 145 551 Annotated 1 w2 1 1 Human Clinical D2010 01 11_ 0152_1011 10203270 Anne Donaldson 1001020 2010 01 11 12 00 440 72 17 11 152 268 Annotated 2 W2W10 1 1 Human Clinical View only clinical slides d P10203270 Anne Donaldson D2010 01 11 S0152 I011 qus Instrument 11 Selections Slide average min max Transferred 2 Temperature 37 00c 37 01 37 05 Freeze 3 C05 5 5 96 5 03 5 66 Discarded 3 aT Temperature 37 0 C C05 5 5 96 f f nn Total instrument average import Delete Export 7 1 2 Overview of data for selected slide The box below the list of slides gives an overview of 7 1 3 Patient data Embryo images last image of each well is shown and the numbers of embryos selected for transfer freeze and discarding are displaye
15. 10 23 12 EE Video of well 6 10 Anne Donaldson P 22007788 Video Images Header Playback Nw Hahtofhesde bouid MA g Start Time h 4 Playback speed this L0 E Label on video z Anne Donaldson P 22007788 Load Logo End Time h 72 Generate 6 5 1 Generate video of embryo s Use the Video sheet to specify a range of parameters for the video The video is generated after pressing the button A header can be placed on the video showing text and the clinic s logo Header Visible Height of header pixels Label on video Load Logo Anne Donaldson P 22007788 The start and end time as well as the playback speed can be specified in the Playback box Page 43 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 Playback Start Time h Playback speed h s 6 5 2 Generate embryo images Video Images Generate Generate Use the Images sheet to export the embryo images in jpeg format after clicking the seem button 6 6 Report This function generates three reports based on information from the EmbryoScope and information from the EmbryoViewer 6 6 1 Laboratory data The laboratory data sheet is used in the laboratory to obtain an overview of the selected embryos chosen for transfer and freezing After use in the laboratory the report can be enclosed in the patient journal All spaces are filled out automatically except the embryo selection spaces the
16. 2010 08 06 10 35 37 049 1 000 1 000 6 732 16 011 Average 37 07 5 35 0 84 5 35 10 18 Page 53 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 8 Settings Settings gt Backup and upload of data Backup of data and upload of data to Unisense FertiliTech A S 8 1 Backup and upload of data to Unisense FertiliTech A S Clicking opens a page with two frames one related to backup of data in the database and one related to upload of data to Unisense FertiliTech A S Data Backup Backup Location Backup Start 0 24h E Backup ViewerlBackup Viewer 2010 07 22 2 2010 08 13 02 00 Total backup files 307 New files 3 Modified files 0 2010 08 12 02 00 Total backup files 307 New files 4 Modified files 0 2010 08 11 02 00 Total backup files 306 New files 4 Modified files 0 2010 08 10 02 00 Total backup files 305 New files 3 Modified files 0 2010 08 09 02 00 Total backup files 305 New files 3 Modified files 0 2010 08 07 02 00 Total backup files 305 New files 32 Modified files 1 2010 08 06 02 00 Total backup files 276 New files 24 Modified files 1 2010 08 05 02 00 16 Total backup files 255 New files 3 Modified files 2010 08 04 02 00 Total backup files 255 New files 5 Modified files 2010 08 03 02 00 Total backup files 253 New files 3 Modified files 2010 08 02 02 00 Total backup files 253 New files 3 Modified files 2010 08 01 02 00 Total backup files
17. 33 06 26 Morphological SAGE eroi i ttd d eee a Rud Sly Un TURON MRNA RUD S IPM dived an N S Prae Ioa Den U QU IQ EN QUE 34 Dd ONORE asne idera ianuiptdue nete unico tUa dvi be neue a Ia amu odresu seno dese uar es cO Ue e ooo lut 34 6 3 ANNOTATE ielea M 34 6 3 1 USING the ANMOLALION TADS ceo eost tta ica a6 Fxsiabti iata GE me eeaeinnee Foto ca eed S e oS Buses te bfc to um pee tais 35 pc MEE Ee Ie e cen oe nn ne ee 36 o gt mG KILO 298 a ez tt e ds 36 6 3 4 Dynamic score Z score and morphological grade sees 36 6 3 5 PEODUCIBISs cc eer mer nee er ats ee i a EUM ene ae ne NEM pM NI E MIN LE 36 6 3 6 ging auiem c E 36 6 3 7 MIGIEMTU CICA To eer EP 37 6 3 0 Bl stomere size and other properties b eet eec uec eee te e e e reo e ave d a EOM edu OUR 37 6 3 9 Selumiat fete e EE 37 6 3 10 Adjusting contrast in the ING SC seo E EEAS E A IE es E E TA EN e usto AE eu e oeque 37 6 3 11 Navigate to previous or riext well i rH rs EHE XV afi e PR RM EHI axe AU IEUER IN AUS 38 6 3 12 Embryo selectiopdm ANN OEALC rrinin aan r in ebeia Ar nara aE atus in EUa Ei 38 6 3 13 Time lapse embryo development in Annotate aessaet nnne 38 6 3 14 Measuting blastome re size ia ree ots ed eet eua r C ES eu eta Y eds Le eva tua sven Dx PA VR n xa v eR Ee 38 6 3 15 SNE CHANCES sciunt lotes petat dedu annon Se tedus e ya duis Deb ats Pesto teda upra dunes se duti coy eaten o e ga
18. 4 5678 Mette Konradsen 19 1990 July 30 0 Male factor 2467 9637 Jubette Weather 21 1989 April 25 0 Male factor 4710 3271 Caroline Rugfeld 41 1969 April 30 0 Endometriosis 5673 8954 Mille Thomsen 31 1979 January 36 0 Azoospermia 4562 3654 Lise Jakobsen 41 1968 December 24 Anovulation 125648 875367 Louise Hansen 30 1980 March 28 0 PCO 0637 9748 Helle Berntsen 23 1987 May 30 0 PCO 3629 8106 Petra Hansen 36 1973 November 20 0 Tubal factor 547689 543275 Tina Thomsen 4 1970 May 23 Unexplained Infertility 1234 5678 Kate Conner 36 1974 May 23 0 Unexplained Infertility A i Sf Pn T P Pc pelete m The data can be sorted by clicking on the header row for each column Double clicking on a patient Patient Details row activates the page 5 1 1 Searching a patient name or ID Below the patient table there is a search space where it is possible to search for a name or number or alternatively part of it Clicking Finda or Q redereves moves the blue highlight bar in the table to the next or previous row containing the name or number Clicking B righisnt J highlights the searched name or number in the table in blue 5 1 2 Create or delete a patient Click mj deletes all the data related to the highlighted patient Click as creates a new patient which can be linked to a slide or treatment ID A new patient can be created on this page before loading slides in the EmbryoScope and then slide labels
19. 46 1 45 9 46 3 0 1 Power Supply Temp 30 0 29 8 30 4 0 1 Outside Temp 22 8 22 6 23 1 0 1 Left Top Temp 28 2 28 1 28 6 0 1 2 Left Bottom Temp 35 1 35 1 35 1 0 0 8 Right Top Temp 30 8 30 5 31 0 0 1 E Right Bottom Temp 31 2 31 1 31 4 0 1 3 Incubator Current 859 802 926 18 8 Motor Current 620 581 659 19 9 Electronics Current 562 a 572 27 Heat Foil Current 691 625 733 11 8 7 7 7 18 Jun 18 Jun 19 Jun 19 Jun 16 Jun 17 Jun 17 Jun 17 Jun 17 Jun 18 Jun 18 Jun 6 4 8 Save QC status and comments QC Mame JBE QC Status Approved 20 05 2010 Comment Backboard Temp Power Supply Temp v Outside Temp v Left Top Temp Left Bottom Temp v Right Top Temp v Right Bottom Temp Incubator Current Motor Current Electronics Current Heat Foil Current When quality check of running conditions are performed it is possible to save the name of the person who has performed the QC the status approved disapproved not checked and a comment to the QC can be added Click NEN to save this information The QC status and comments added are also shown on the instrument view page accessed by clicking Page 42 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 6 5 Video Video The Video button becomes active when 1 12 embryos have been selected on either the View Slide or Timeline page Thursday 20 May 20
20. 73 8954 Time since fertilization 104 0 Ge 3 Lise Jakobsen 4562 8654 Time since fertilization 98 6 Ge 4 Maria Baker 2457 8754 Time since fertilization 78 6 Rep 5 Anne Holm 4631 9535 Time since fertilization 54 6 EC 6 Caroline Rugfeld 4710 9271 Time since fertilization 5 6 Temperature 37 0 OC CO 5 5 0 5 896 Status Microscopy Slide 2 Last Reading 14 37 Page 14 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 This page shows all running slides from all EmbryoScopes connected to the EmbryoViewer e Shows up to 4 connected EmbryoScopes e Shows up to 6 running slides from each of the connected EmbryoScopes e For each slide patient name patient ID and time since fertilization are shown e For each connected EmbryoScope the current incubation condition are shown incubation temperature and gas concentrations e Status of the EmbryoScope e Time for last reading of data from the EmbryoScope 4 1 1 Running slides Click on one of the running slides and the corresponding slide overview is shown Note that running slides are not shown in the database overview pages View All Slides and Instrument as these slides are not completed When a slide is ended in the EmbryoScope all the data related to this slide will appear in the database overview 4 1 2 Alarm status If an alarm occurs in the EmbryoScope the title bar will be colo
21. Data report page section 6 6 1 5 2 14 Save patient details Click EN and save all updated patient information in the patient details and the treatment box Page 22 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 6 Slides Slides Slide and embryo details Treatment ID 2nd treatment PE rss 1st treatment b Treatment ID if a patient has several treatments these are shown D2010 05 12 S0083 I023 D2010 05 12 50082 1023 D2010 05 12_50081_1023 z AMAA AC C o TAD J gt Slide ID if several slides belong to the same patient these are shown Shows time lapse films of embryos from the specific slide gt Shows embryos from the specific slide in a timeline view Detailed view of embryos for annotation of e g cleavage times Running conditions for the specific slide e g incubation temperature and gas concentration Exports video sequences and single images Generates report sheets laboratory data instrument data patient information This part of the EmbryoViewer provides the user with an overview of the embryo time lapse information 6 1 View slide When clicking the button images of all embryos in the active slide are shown on the screen The positions of the images on the screen are equivalent to the positions of the embryos in the EmbryoSlide The last
22. Database 49 Deleting a slide 52 Detailed running information 40 Disposal of Waste 60 Dynamic score 27 Dynamic score Z score and morphological grade 36 Embryo selection buttons 27 Embryo selection in Annotate 38 Embryo selection in Timeline 32 EmbryoViewer introduction 12 Exporting data from the database 52 Filters and sorting of data 50 Fragmentation 36 FTP connection to Unisense FertiliTech 56 Generate embryo images 44 Generate video of embryo s 43 Grading embryos 11 Importing a slide 51 Incubation 39 Index 61 Inspection of running conditions 39 Instruction and installation 13 Instrument 52 Instrument data 46 Introduction 12 Laboratory data 44 Linking slide and treatment 22 List of slides 49 Magnification of images on Timeline 33 Measuring blastomere size 38 Morphological grade 34 User manual v3 0 Multinucleation 37 Navigate to previous or next well 38 Number of timepoints shown and zoom level 31 Overview of data for selected slide 50 Overview of functions in the navigation panel 7 Patient details 19 Patient information 47 Patients 17 Print reports 48 Printing barcode 20 Pronuclei 36 Quick guide 7 Report 44 Running 14 Saving changes 29 39 Saving QC status 42 Searching a patient name or ID 18 Selecting embryos for annotation 29 Settings 54 Shortcut 29 34 Slide type 28 Slides 23 Timeline 29 Upload of patient inf
23. EmbryoViewer User manual UNISENSE FERTILITECH Caution Federal law restricts this device to the sale on the order of a physician EmbryoViewer 3 0 User manual v3 0 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 1 IMPORTANT restrictions and warnings The following restrictions and warnings shall ensure safe and correct use of the EmbryoViewer by qualified personnel in a Fertility Clinic The EmbryoViewer is used together with the EmbryoScope to select viable embryos for transfer in a fertility treatment Proper evaluation and selection of embryos for transfer is essential to provide a successful treatment to patients All personnel using the EmbryoViewer must therefore agree to read and understand this user manual must observe the restrictions on use and heed the warnings below to be allowed to operate the EmbryoViewer Restrictions on use The EmbryoViewer may only be used by qualified personnel trained by Unisense FertiliTech A S employees Users should contact Unisense FertiliTech A S immediately to report any incident and or injury to a patient operator or maintenance employee that occurred as a direct or indirect result of operating the EmbryoViewer Access to the EmbryoViewer must be controlled so that only qualified trained personnel have access to the EmbryoViewer Untrained personnel could inadvertently change the annotation or selection of embryos so it is essential t
24. I x On Dion bwin ee 2 Embryos Transferred Confirmed 9 9 Freeze Container 1 5 6 straw 2 Comment 5 2 11 Linking slide and treatment In the slide box a slide can be linked to an existing treatment using the Slide Treatment ID drop down menu Slide Treatment ID NOTE It is essential that the correct patient ID is chosen on the EmbryoScope if a new slide is added to an existing patient or treatment 5 2 12 Changing fertilization time Fertilization date and time can be manually changed after the slide is ended on the EmbryoScope Fertilization Fertilization Date 2009 05 11 Fertilization Time hh mm 11 15 NOTE changing fertilization date and time and clicking Save overwrites the original fertilization date and time from the EmbryoScope The original fertilization date and time can only be restored by importing the raw data from the EmbryoScope again 5 2 13 Embryo specific information Information related to specific embryos embryo ID and description can be written when adding a slide on the EmbryoScope and this information is listed in the panel Selecting embryos for transfer freezing or discard will appear on this list The Well Description space is editable so additional information on specific embryos can be inserted here after a slide is ended For example information on location of freezing can be written here and will appear on the Laboratory
25. N a n 25 b COMIN ISTO Sie uis bites tepistlioo fea e nde ene tue ptetqnt i mesi bbted uu ve ao ep quiu assu tbc dde dO 26 6 4 jBlastomere aCtVIbV usos etes dba teda eiim este uia dte istam du beissubsh cmt cu Mises EE Uto deben d xta M t bis 27 6 1 5 DYNAMIC SCO Cy acac PI I S LIE 27 CLO Embryo selection DUTEONS oscura idu n eR E OE ib tape d ceca emu mena eee aaa 27 6 17 Annotations regarding trie slc estet opta p p tette ien Ip a Ri Entee tactu ta iom RU erp Ms enit tuni ae 28 c E SNS BY a A E A E A 28 6L9 Savingchallges ueser r rE E E DDR aM M EEO 29 6 1 10 Selecting emDpryos Tor annotat ON sadscctvyceraciessandiescadncreu dex ads eov vivan dere t osa n vad AA IRE Des 29 6 1 11 MOC Rae ees e TEETH ER 29 6 2 MAIMCUING snn E eese dece vea uestes cavensedaaseapeaeesseneseres 29 6 2 1 Choosing displayed time points ccccccssssccccsscccceeececaeecccseauececseusceseaeseeseaeeeseuecesaueeeesaaeeesseaseeessaeeeesaes 30 6 2 2 Number of time points shown and zoom leVEl ccccccssssscccccesseccccceeeseccccceeeecceeeuaesceesueaeceessuaeceesaaanseess 31 62 35 Embryo selectiondh TIMENE ssec ostia e CUR RU QUiae aav s aco Cubo neu avorum aeo o pu Rove edP etaed Ont di pta e pO Seda EOS 32 6 2 4 Viewing different focal planes st ousisdco tattoo e ab ao b OE po re ise uep esa tuos eobt ent vac ve vis dei Mo aas pa s eo Oo D Pe Mid ee Reus 33 62 5 Maenificationordqmases n TESTIS ssscecsvu eit xd rena atr E P et EE SPI E I ER ERE
26. OD GSC ERE 49 7 1 Wi GW EIEnilqe D 49 PN MEME E donec NR A A A AO 49 Z2 ONEIVIEW OF data ftorselected slide oes evtiaa oett une ober eet ou eerte ub ueni eva eam utetur Soa os pat do E 50 7 1 3 Filters and Sorting OF data oder n ORIS YEA SEE Fo E xvi e re VeR EAR OK OPES NE 50 JAA MDOE Eco EU DEDE 51 7 1 5 Delete aSa cR EE D E LU mE 52 ALO xporting data Tromeudthe Catalase sudden dede duis eie Sepa edo ati ddetiesdue dence Supe tee o a ceeti ace 52 7 2 MSME der 52 7 2 1 List of running conditions for all slides eee eeecccesseccceeeeccceeeececeeececeueececencesseeceesueceseuecetseneceetenseseeees 52 7 2 2 Average incubation conditions for all slides ue emet ei e ete Eve pere tuba ee oa edi edes uk ed P Yer edis a vuv eas Cos 53 Setting S ossi sede aD pd SIEIP diva det voa Odo Udo eT oI d Tepic et iiu Diu Lo IU d eiauke 54 8 1 Backup and upload of data to Unisense FertiliTech A S ecce eee eee 54 8 1 1 EmbryoViewWer sortWake Vel SIOTI s aee i e E UTERE i aset iei texte E to iint meri ne Oe 55 8 12 Slides Tor data agreement sso saevevin Fe vex iu itedveien vat vesisn nevera vais sedie Te va sE wn CR eva d adtnaodyadevinceasansencusee Md 55 8 2 Data D ie de PERIIT UIT TI MD ES 56 8 3 FTP connection to Unisense FertiliTech A S ccccsccsccccsccscccceccsccecccceccscccceccsccececceccsceccecens 56 5 5 1 Data upl
27. This data is also stored in the database and can be exported with annotations to an Excel file The EmbryoViewer software does not control any hardware components in the EmbryoScope and thus has no influence on the incubation of embryos If the EmbryoViewer fails or is shut down by e g a power failure the EmbryoScope continues to run and data is saved on the EmbryoScope Page 12 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 3 2 Instruction and installation Unisense FertiliTech A S employees will undertake device setup installation of software and training of personnel involved in the routine workflow using the device Unisense FertiliTech A S will perform maintenance and software update to ensure efficient use of the EmbryoViewer workstation Training and instruction of personnel will be performed by Unisense FertiliTech A S employees coincident with installation of EmbryoScope and or EmbryoViewer Page 13 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 4 Running Running instruments View all running slides from all connected EmbryoScopes In this part of the EmbryoViewer it is possible to inspect running slides in EmbryoScopes connected to the EmbryoViewer workstation 4 1 View running View Running tirsdag 25 maj 2010 14 38 93 Instrument 7 EC 1 Gertrud Jansen 2456 Time since fertilization 103 0 EC 2 Mille Thomsen 56
28. Viewer 3 0 User manual v3 0 Monday 31 May 2010 21 34 ggg Z oom 55 X V Don t show discarded Save 2 Timepoints shown Jee ope 6 2 3 Embryo selection in Timeline The four embryo selection buttons for transfer freeze discarding and further observation described in section 6 1 6 are also available on the Timeline page d a s 8 Embryos that should be discarded can be marked with the xj button giving the embryos a red background color If the Don t show discarded checkbox is checked the discarded embryos will no longer be shown on the page By removing the discarded embryos from the page more space is available to enlarge the remaining embryos 4 Don t show discarded Save If some embryos have been selected for discarding on the View Slide page and the Don t show discarded checkbox is already checked when opening the Timeline the discarded embryos are not shown when the slide is initially opened in Timeline Page 32 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 The embryo selections are saved by pressing the mr button If an attempt is made to update or leave the page before saving a dialog box will appear asking whether or not the user wants to save the changes before proceeding 6 2 4 Viewing different focal planes The different focal planes of the image can be viewed by placing the curser over an image no clicking and scrolling with the
29. a to Unisense FertiliTech A S the clinic will grant Unisense FertiliTech A S the permission to use information derived from the data to improve future products free of charge royalties to the entities that have uploaded the data Page 56 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 It is possible to automatically upload new data to a Unisense FertiliTech A S FTP server every night V Enabled Connection Type FIP by selecting the type of connection is specified d When there is new data to upload the data is uploaded to Unisense FertiliTech A S If the internet connection has been lost a forced upload of data can be performed by clicking Dew Uploaded files are listed with date and filename 20 05 2010 03 53 13 D2010 05 18 50098 I023 pdb 20 05 2010 03 52 54 Annotation 2 1 0 257 20100520 0352 pdb 19 05 2010 22 52 46 Annotation 2 1 0 257 20100519 2252 pdb 19 05 2010 17 52 37 Annotation 2 1 0 257 20100519 1752 pdb 19 05 2010 14 47 Annotation 2 1 0 257 20100519 1447 pdb 19 05 2010 11 57 Annotation 2 1 0 257 20100519 1157 pdb 19 05 2010 07 22 D2010 05 18 50098 I023 pdb 19 05 2010 07 22 Annotation 2 1 0 257 20100519 0722 pdb RESTRICTIONS ON USE The clinic shall be solely responsible for ensuring that all local rules and regulations are observed in connection with the upload of data to Unisense FertiliTech A S and that patients are informed about such upload of data RESTRICTIONS ON USE Uploa
30. a typed in by the user The EmbryoViewer assists the user in selecting the best embryos by allowing for inspection of high resolution time lapse images of embryo development detailed annotation tools and inspection of EmbryoScope running conditions The EmbryoViewer workstation provides e High resolution time lapse images of single embryos e Embryo annotation tools assisting in selecting embryos e Inspection of incubation details e g temperature and gas conditions e Export of data for statistical analysis The EmbryoViewer workstation is an accessory to the EmbryoScope The EmbryoScope provides a safe controlled culture environment while allowing continuous monitoring and observation of up to 72 embryos at a time Data from the EmbryoScope can be viewed in the EmbryoViewer This includes embryo images incubation details alarms log files and other instrument parameters The EmbryoViewer workstation can be used to review and compare synchronized time lapse movies of different embryos In addition the EmbryoViewer contains a simple database which enables the user to annotate time lapse images for e g cleavage times fragmentation multinucleation pronuclei and other characteristics used for selecting the best embryo Annotations are saved in the database and can be exported to an Excel file for statistical analysis The EmbryoViewer also enables input of patient details treatment data and outcome data
31. and embryo ID For detailed information on how to link patient ID to treatment and slide ID see section 5 2 11 Patient name and ID Patient name and ID number can be written into the patient file both on the EmbryoScope and on the EmbryoViewer Adding a slide on the EmbryoScope creates a new patient with the patient information written on the EmbryoScope A new patient can also be created on the EmbryoViewer and adding a slide in the EmbryoScope with the same patient information links the patient information from the EmbryoViewer to the slide started on the EmbryoScope Treatment ID Each patient has one to several treatments The treatment is always named Unknown when a slide is started The treatment can be renamed so it is possible to distinguish between succeeding treatments Slide ID Each slide has a unique number consisting of date slide and instrument number Slides can be reallocated to treatments using the Patient Details page Embryo ID Each embryo has an ID number which is created when a slide is added on the EmbryoScope The embryo ID is shown on the Annotate page in the blue header bar on the Patient Details page and on the Laboratory Report page Patient name and patient ID TreatmentID Treatment ID Treatment ID Slide ID Embryo ID Page 8 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 2 3 Colour guide Patient Details Available but not selected active but
32. can be written in the white spaces to the left of the embryo images When Update clicking on the uiae button at the bottom of the page images of the embryos are displayed at the selected time points Time points do not need to be written chronologically as the update function will order them chronologically Well 1 Morphological Grade Time h Page 30 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 6 2 2 Number of time points shown and zoom level The number of time points shown can be changed in the Time points shown drop down menu at the bottom of the page Up to 10 time points can be chosen and will be displayed after clicking the update button Timepoints shown Zoom 96 4 v Update 30 v The more time points chosen the smaller the displayed images since the space on the screen is limited Pe Pe rannin 3 a i SS SEN AIP 1 vj e x 2 EEPPPPEPPEEPEPE EE BI ES P EP DS ES BEBEBEESEBEBEBBEBI IPIS IP IP ID D DII E EEEPSESEESEEBSEE Save v 3 X 2 The zoom level can be changed manually on the Zoom drop down box The larger the zoom number the larger the images displayed When more time points and or embryos are chosen than can be displayed on the page a scroll bar appears to the right of the images Page 31 Unisense FertiliTech A S Embryo
33. ce are shown in the list of annotations Page 38 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 Monday 31 May 2010 22 01 EE ID 5 Cels Visible nude 2 0 Dynamic Score Z Score Morphological Grade 457 4 Pronudet PN PN 3PN PN Elipse Fragmentaton 9 0 10 10 20 20 50 5 100 j 5 2 85um Multinudeason 0 gt cels out of 2 cels Naked Irregular Division Ovod Blastomere Sze Granular Even Uneven Zona pelucda defect Comment Contrast well Previous Next l J a ed Dj iir um iem Le JL Le 6 3 15 Saving changes Save Click the EN button to save all annotations If an attempt is made to update or leave the page before saving a dialog box will appear asking whether or not the user wants to save the changes before proceeding 6 4 Incubation 6 4 1 Inspection of running conditions During a run on the Embryoscope and or as a final quality check QC it is possible to inspect the running conditions for each EmbryoScope instrument Incubation details can be inspected by m batio clicking or finding the slide in the instrument overview table accessed by Page 39 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 Running conditions for CO and O are only shown if CO and O regulation is chosen on the EmbryoScope Running conditions for temperature and gas are shown on graphs Door openings are indicated by a bla
34. ce of the EmbryoScope instrument cannot replace an actual monitoring of the EmbryoScope instrument The performance of the EmbryoScope Embryo Monitoring System must therefore be checked on a regular basis through control of the EmbryoScope itself e The device may only be operated by trained personnel Only trained personnel may annotate and select embryos as personnel that are not properly trained could inadvertently or deliberately change the embryos that are selected for transfer It is essential that the identity of embryos selected for transfer is rigorously checked before transfer from the EmbryoSlide to the transfer catheter The appearance of the embryo in the microscope used for loading the embryo in the catheter MUST match the appearance of the embryo on the last acquired image as printed out on the laboratory data report The patient ID and patient name on the laboratory data Report MUST match the label on the EmbryoSlide AND the label on the catheter Backup of image and patient data MUST be performed at regular intervals Automated nightly backups to a safe external hard disc can be implemented through a selection in the settings tab e The clinic shall be solely responsible for ensuring that all local rules and regulations are observed in connection with the upload of data to Unisense FertiliTech A S and that patients are informed about such upload of data Installation and maintenance e Installation inspecti
35. ck cross on the graph Temperature v CO2 Conc v CO2 Flow V CO2 Pres v 02 Conc M N2 Flow v N2 Pres o o on w D un o o o N w gt aeq aunssadd ZN CO2 Concentration and Flow I N e N ow m S th o Ww N e e N aeq aunssaig ZO2 a en e O2 Concentration and F low Ih o e wn 04 maj 04 maj 04 maj 04 maj 04 maj 04 maj 04 maj 04 maj 04 maj 04 maj 04 maj 04 maj 04 maj 04 maj 04 maj 04 maj 05 maj 05 maj 05 maj 05 maj 05 maj 05 maj 05 maj 05 maj e Top graph Incubation temperature blue e Middle graph CO concentration blue flow green and pressure pink e Bottom graph O concentration blue flow green and pressure pink For all graphs it is possible to include or exclude the parameters shown on the graph by clicking in the checkbox W Temperature W CO Conc lf CO Flow W CO2 Pres W OF Conc N2 Flow I HN Pres The axis on the graph rescales automatically in accordance with the parameters chosen 6 4 2 Zoom of graphs To zoom on a specific part of one of the graphs drag the cursor from left to right to zoom out drag the cursor in the opposite direction from right to left 6 4 3 Detailed running information Below the graphs detailed information on running conditions for the selected slide are shown in different sheets Page 40 Unisense FertiliTech A S EmbryoViewer
36. d Instrument data average temperature and gas concentration data for the selected slide and overall for the instrument Filters and sorting of data For each of the columns a menu will be opened if the header is clicked The data can be sorted in ascending or descending order and for some of the parameters the menu includes filters to include or exclude some of the data Filters can also be reset in the menu If the checkbox View only clinical slides below the list of all slides is checked only human clinical Slides are displayed in the list of slides Page 50 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 7 1 4 Importing a slide If the EmbryoScope is connected to the EmbryoViewer the finished slides are automatically imported to the database in the EmbryoViewer M If there is no connection the button can be used to manually import the finished slides from the EmbryoScope after the datafiles have been moved to the EmbryoViewer using for instance a USB stick Clicking the imported button opens a dialog box from which one or multiple slides can be Monday 31 May 2010 22 09 2 Slide ID Patient ID Patient Nam Treatment Fertilization Start End Instrument Slide Runs Annotations Transferred Wells Gestational Sacs Fetal Heart Beat Slide Type Instrument QC Comments D2009 10 20_ 0080_1011 10203040 Linda Crown 1001001 2009 10 20 13 00 2 92 71 20 11 80 203 Annotated 1 w
37. d by the fertility clinic If the patient ID is a social security number of any other traceable personal ID number it may NOT be uploaded to Unisense FertiliTech A S Page 58 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 9 Acknowledgements All identification numbers names and treatment data presented in this manual is purely fictive We acknowledge IVI Valencia Spain and Marcos Meseguer for providing the embryo images Page 59 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 10 Disposal of waste Identification of risks associated with the disposal of the EmbryoViewer and its accessories In order to minimize the waste of electrical and electronic equipment waste is disposed according to the Directive 2002 96 EC Waste Electrical amp Electronic Equipment WEEE Page 60 Unisense FertiliTech A S EmbryoViewer 3 0 11 Index Acknowledgements 59 Adjusting contrast in the image 37 Alarm status 15 Annotate 34 Annotations regarding the slide 28 Association between different ID s 8 Average incubation conditions for all slides 53 Backup and upload of data to Unisense Fertilitech A S 54 Blastomere activity 27 Blastomere size and other properties 37 Cell divisions 26 36 Choosing displayed timepoints 30 Colour guide 9 Comments 37 Contact Information 62 Create or delete a patient 18 Data backup 56 Data uploaded to Unisense FertiliTech A S 57
38. d of data may only be initiated IF THIS IS PERMISSIBLE BY LAW AND REGULATIONS in the country where the EmbryoViewer resides 8 3 1 Data uploaded to Unisense FertiliTech A S Data can be uploaded with different levels of information NOTE Information from the variable Patient Name will never be uploaded V Upload well annotations to Unisense Fertilitech Upload of patient information to Unisense Fertilitech NO upload Patient information without Patient ID NOTE Patient names will NEVER be transferred e Upload well annotations to Unisense Fertiitech Upload only slide data this includes embryo images embryo annotation e g cleavage patterns an auto generated slide ID number running conditions Page 57 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 8 3 2 Patient information uploaded to Unisense FertiliTech A S NO upload No patient information is uploaded Patient information without Patient1D Upload slide data see above and patient treatment and outcome data without uploading data from the Patient ID variable Patient information with Patient I Upload slide data see above and patient treatments and outcome data including data from the patient ID variable information from the variable Patient Name is never uploaded RESTICTIONS ON USE Only anonymous data may be uploaded to Unisense FertiliTech A S Patient ID may only be uploaded if the ID number is an internal number use
39. eecceeeaeseceecseeseccesseeeceessuaaecessseeaeeeeseanees 11 245 Gradihg NOI OS sia tagactecte nance yesh asatntee cate gasti dede cedu D o coSed ons uot ecce oM xU suce aU dee ce acie 11 diidgore ljo g o RbNUMER C E 12 3 1 EmbryoViewer introductiofi cose pese a eo Bex e xaO REN an ea PRESBOU S EVRPE S DOSU RU RUNE E VRE P Uso u Kun eu ERE AUS 12 3 2 Instrucuon and Installation ito end VeE Ro eple PR I PREND SPI EREC OE es ence RES END I A QUI RE OA LUPIS REI UUE 13 RUNNING ES TETTE T NTm sn 14 4 1 VICW TURINE wusctancaunsctesetett Gocutiewieteis vi oEE dua a Do bue sula MUS FvaNi UR aD v To bU Oan EDD VERE o PRM OU E dU RUE 14 4 1 1 RODAIN SILC rene E E E NU LLL IURE TENTER EO RS 15 ALZ Alarm Staltllsssedentiteu m Ut d pi ume endo t titaum m psi dunt O unu ibas 15 d ij nip M 17 5 1 View all ep RTT 17 5 1 1 Searchilig a pauent Name Or ID sss rteneteoredo tat urt es auto ie Rep toe eben oo eed ceu upto nic ep ples us 18 5 1 2 Create or delete a patiente sen a 18 5 2 Patient details anise 19 5 2 1 Detailed patient and treatment INFOrPMAtION cccccccssssecccccssseccecccaesecceesausseceeseueceessueaecesssuaaeeeesaaaaseess 19 5 2 2 Patierittetallsso cn eu oue Mu e EINE ERE LM IM M LM CDM M AM ene I eM eer E 19 5 2 3 PIVEN SIS Ty Ol siete essere ES 20 5 245 dJreatmentinfoEtt
40. elected for transfer Selected images get a green background e The ka button marks embryos selected for freezing Selected images get a blue background x e The x button marks embryos for discarding Selected images get a red background D e The 2 button marks embryos where decision making is not possible at the time of marking Selected images get a yellow background When for example the x button is clicked the icon V is shown to the right of the cursor indicating that the transfer tool is active One or more embryos for transfer can now be marked by clicking on the images whereby the images get a green background Return to normal cursor use is done by clicking on the Transfer tool button again The other three tools work in the same manner 6 1 7 Annotations regarding the slide Description Annotation comment Initials Status Slide type zl Not Checked d Not Checked Ls ki a Spaces and drop down menus for slide description initials of annotating personnel status of annotation Slide type and an annotation comment are provided at the bottom of the screen 6 1 8 Slide type Slide type Human Clinical The drop down menu for slide type has the following options e Human clinical e Human test e Animal test e Other test e Not checked Page 28 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 6 1 9 Saving changes Save Click the EN button to save all updated information o
41. eport patient name patient ID treatment ID and date of report printed are shown This sheet can be handed out to the patient Laboratory Data Patient Name Ann J Donaldson Patient ID 1234 5725 Treatment ID Treatment gi Embryo Summary Embryos transferred Embryos frozen Page 47 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 6 6 4 Print reports Choose all or only some of the reports to be printed in the print checkbox Reports to print V Laboratory data Instrument data Patient information Print Page 48 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 Database Database C gt Database of all acquired data View All Slides Lists all slides including e g fertilization time outcome data and instrument QC status Instrument Lists all slides and running conditions for each slide 7 1 View all slides uu View All Slides l E When clicking the button all slides are listed with information on e g fertilization time primary outcome data and instrument quality control status When clicking on a line it is coloured blue and throughout the EmbryoViewer the patient treatment and slide belonging to the line are now active 7 1 1 List of slides For each slide the following parameters from the database are displayed e Identifiers slide ID patient ID patient name treatment ID e Fertilization time e Start and end time of incubation i
42. es 16 Modified files 101 19 05 2010 02 02 Total backup files 314 New files 17 Modified files 101 18 05 2010 02 05 Total backup files 305 Mew files 17 Modified files 97 17 05 2010 02 01 Total backup files 238 New files 10 Modified files 0 16 05 2010 02 01 Total backup files 238 New files 10 Modified files 0 Clicking Wr performs a forced data backup A forced data backup creates an extra backup file and does not affect the daily data backup WARNING Backup of image and patient data MUST be performed at regular intervals Automated nightly backups to a safe external hard disc can be implemented through a selection in the settings tab 8 3 FTP connection to Unisense FertiliTech A S It is possible for users to upload anonymous treatment data images temperature and gas readings procedure outcome etc to a secure FTP server at Unisense FertiliTech A S to facilitate quality control and off site quality control Users have expressed an interest in a built in feature to do this automatically every night Unisense FertiliTech A S will keep the data on a secure server and will not distribute the data The sole use of the data will be to evaluate if the instrument is operating properly and to report back to the clinic if any advance sign of irregularities are observed Unisense FertiliTech A S intends to do a technical review of the uploaded data on a regular basis but will not be obliged to do so By uploading the dat
43. gh patient and treatment details The navigation panel shows patient name and patient ID of highlighted slide in the patient overview NOTE Patient information e The clinic shall be solely responsible for ensuring that all local rules and regulations are observed in connection with upload of patient information to Unisense FertiliTech A S and that patients are informed about such upload of data Only anonymous patient information may be uploaded to Unisense FertiliTech A S PATIENT ID MAY ONLY BE UPLOADED IF THE ID NUMBER IS AN INTERNAL NUMBER USED BY THE FERTILITY CLINIC If the patient ID is a social security number or any other traceable personal ID number it may NOT be uploaded to Unisense FertiliTech A S 5 1 View all patients View All Patients This page lists all patients in the database The information listed is e Patient ID and name e Age e Birth year and month e Body mass index BMI e Diagnosis e Comments regarding the patient Page 17 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 Patient ID Patient Name Age BirthYear Birth Month BMI Diagnosis 1234 5678 Kate Conner 36 1974 May 28 0 Unexplained Infertiity 547689 543275 Tina Thomsen 40 1970 May 23 Unexplained Infertility 3629 8106 Petra Hansen 36 1973 November 20 0 Tubal factor 0637 9748 Helle Berntsen 23 1987 May 30 0 PCO 125648 875367 Louise Hansen 30 1980 March 28 0 PCO Patient ID Patient Name 35 1975 January 25 0 None 123
44. hat the EmbryoViewer is installed in a secure place not accessible by patients or the public While the EmbryoScope facilitates safe handling and access to information about the embryos in a particular treatment it can only supplement and NEVER replace proper security measures to ensure that embryos selected and transferred belong to the proper patients All standard procedures for labeling and validation of identity for EVERY transfer of gametes and embryos between vessels MUST be maintained Upload of data to Unisense FertiliTech A S is a service to fertility clinics to facilitate quality control and off site quality check of instrument performance It may only be initiated IF THIS IS PERMISSIBLE BY LAW AND REGULATIONS in the country where the EmbryoViewer resides The clinic shall be solely responsible for ensuring that all local rules and regulations are observed in connection with the upload of data to Unisense FertiliTech A S and that patients are informed about such upload of data Only anonymous data may be uploaded to Unisense FertiliTech A S PATIENT ID MAY ONLY BE UPLOADED IF THE ID NUMBER IS AN INTERNAL NUMBER USED BY THE FERTILITY CLINIC If the patient ID is a social security number or any other traceable personal ID number it may NOT be uploaded to Unisense FertiliTech A S The data received by the EmbryoViewer workstation about the Page 2 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 performan
45. i 1 1 Human Clinical D2005 11 05 50052 I018 P10203050 Jessica Geithner 1001002 2009 11 05 11 00 1 44 96 73 18 52 528 Annotated 2 W5 W6 1 1 Human Clinical Annotation cq D2009 11 17_S0109_1011 P10203060 Ursula Hansen 1001003 2009 11 17 12 00 4 84 71 72 11 109 198 Annotated i w6 0 0 Human Clinical D2009 12 01 50119 I011 P10203070 Birgitte Nielsen 1001004 2009 12 01 12 00 3 48 70 91 11 119 201 Annotated 2 wiw2 0 0 Human Clinical D2009 12 06 51013 I004 P10203080 Mary Jones 1001005 2009 12 06 14 00 2 52 114 90 4 1013 325 Annotated 2 W3 W6 2 2 Human Clinical D2009 12 11 51030 1004 P10203090 Elizabeth Thompson 1001009 2009 12 10 13 00 20 29 117 96 4 1030 290 Annotated 1 w6 0 0 Human Clinical D2005 12 15 50130 I011 P10203110 Linda Brown 1001010 2009 12 15 14 00 0 78 69 76 11 i30 3 Annotated 2 W2W6 1 1 Human Clinical p2009 12 15_ 1040_1004 P10203120 Barbara White 1001011 2009 12 14 14 00 19 90 117 08 4 1040 157 Annotated 2 W6 W9 0 0 Human Clinical D2009 12 16 S1044 I004 P10203130 Jennifer Redford 1001013 2009 12 15 14 00 21 97 93 08 4 1044 205 Annotated 2 W6 W7 0 0 Human Clinical D2009 12 23 50139 I011 P10203150 Pamela Peterson 1001015 2009 12 23 16 00 0 15 65 35 11 139 259 Annotated 1 w6 0 0 Human Clinical D2009 12 28 50145 I011 P10203160 Marie Spingfield 1001016 2009 12 28 14 00 0 62 139 57 11 145 551 Annotated 1 w2 1 1 Human Clinical D2010 01 11 S0152 I011 P10203270 Anne Donaldson 1001020 2010 01 1112 00 4 40 72 17 11 152 268 Annotated 2 W2W10 1
46. ication Protocol Oocyte Source Media Type HCG Test Abortion Unknown X Unknown X Unknown v Unknown v Unknown m Medication Brand Oocyte History First Medium Brand Gestational Sacs Abortion Comment Unknown X Unknown v Unknown v Unknown x Triggering Oocytes Aspirated Second Medium Brand Fetal Heart Beat Unknown T Unknown 7 7 Unknown X Unknown X Total FSH Dose 1U Sibling Embryos in Standard Incubator Media Change Live Born Babies LH Supplement Unknown X Unknown v Unknown X Comment Comment Slide ID D2010 04 07_S0171_I006 Patient Details Patient ID Fertilization 1234 5678 Slide Treatment ID Fertilization Date PET URE rear Treatment 02 2010 04 06 Patient Name Slide Description Fertilization Time hh mm Ann J Donaldson 12 00 Birth Year Birth Month Fertilization Method 1972 E 6 ad Unknown x BMI Basal Serum FSH IU I 0 Embryos Transferred 25 0 Un confirmed Comment Diagnosis PCO M Page 55 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 8 2 Data backup Data backup includes backup of the slide database and backup of the main and patient database It is possible to specify both a backup location and a backup time Backup Location Backup start 0 24h C Backup E 2 Data backup are performed daily on the specified time Backup files are listed with date and time 20 05 2010 02 02 34 Total backup files 320 New fil
47. id Blastomere Size Even Granular z i Uneven Zona Pellucida Defect The spatial symmetry of the blastomeres can be annotated at for instance the 2 4 and 8 blastomere stadium Various other properties can be annotated by checking the check boxes The annotations will be shown in the list of annotations and a small red dot is shown at the bottom of the division chart to indicate an annotation 6 3 9 Comments Comment Up to 10 comments can be added to the list of annotations 6 3 10 Adjusting contrast in the image Contrast Image contrast can be adjusted by sliding the bar Note this will not change the original images but only they way the images are currently displayed Page 37 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 6 3 11 Navigate to previous or next well Well Previous 6 3 12 Embryo selection in Annotate iJ bd e The four embryo selection buttons described in section 6 1 6 are also available in Annotate 6 3 13 Time lapse embryo development in Annotate Film speed E n gt Normal All options for playing the embryo time lapse film described in section 6 1 1 are available in Annotate 6 3 14 Measuring blastomere size The ellipse tool can be used for estimating the area of a blastomere and or fragment The distance tool did can be used for estimating the diameter of a blastomere and or fragment Area and distan
48. igtlOD ease test Etui tole San atem E A a 20 5 2 5 Du srelfezidro M cT 20 5 2 0 OOCyte JJHTOFmatiOD sese eri ovv teko i EE Tr pela evi a NEEE TE V ER RR eR S ocu Eua oae ru Duvet E MY RES Ded 21 5 2 SUM conditioDisssimaeenieieeteo ai odebra E ae sedie yin eso tsduu E ups trus S 21 5 2 8 CUT COI uec ETE 21 5 2 9 Wiultiple slides ith treatmelit doeet eter divenne et NIE n Eo hi tt dede P aede detto duc eo uat peto eem etu 21 5 2 10 Slide InTorimatlolisuedieasecotn Lose vadis E td Dna a tator tub essa tatis kon eepe 21 5 2 11 Hinke slige dnadteat lleno estie db IR rbd eb i teti ta toton Ep tee si ob tate dn inita ieu pda UO EUR ED MEE 22 5 2 12 CHANING Terlization tITIQus ivi S bonlbie v hate eio en tro m en im saab lim av been amid iei bane 22 5 2 13 Embryo SPECIFIC INTOPMALION si se steve rv a Sut Eva vedd s Den quU pa RU s eva UR Rex Duo SV VE a P SQUE E UE 22 5 2 14 Save Patient detalls naak a tute ved ese tiun denne nd ecesaeiel edes seh Biete dee su casein endo dana Medus pode 22 eTe lc 23 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 6 1 VI GW SING PC 23 o LlI Timelapse embryo developITiBliE sis ceori sv E au eese Sa ead ex S ru ue vu PRG Ea EUR Das Pate ivre alatus imet es 24 6 L2 Different TOCA plali6suieioe ei prt US e Ea uve Vete oM NEEE RUE vu T ugue oC bN Mu Ud usa uut HN AU va Ua Hoa R
49. image of each embryo taken during the incubation is shown Film speed Le l Ld Led Ej Led Leeds Page 23 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 6 1 1 Time lapse of embryo development Viewing time lapse scroll wheel The embryo development can be viewed by turning the scroll wheel the PowerMate with the blue light Turning the scroll wheel clockwise displays the images of the embryo forwards in time turning the scroll wheel counter clockwise displays the images backwards in time Division chart The black triangle shows which position the presently shown image has in the entire film of the embryo development illustrated by the green division chart Viewing time lapse buttons Alternatively the time lapse images can be viewed by using the buttons in the panel at the bottom of the page B Film speed ej Le Pn 44 e Clicking displays the previous images in the time lapse gt e Clicking gt plays the time lapse film for all embryos on the slide When pressed again T n appears and the film pauses er e Clicking gt displays the next images in the time lapse series Film speed e Preferred film speed can be chosen in the drop down menu Page 24 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 Viewing time lapse mouse The displayed image can also be changed using the mouse to click on the new desired position in
50. licking the Delete 7 1 6 Exporting data from the database button deletes highlighted slides User manual v3 0 Export Clicking the Ea button exports patient data and well annotation data for highlighted slides to a Microsoft Office Excel 97 2003 worksheet 7 2 Instrument 7 2 1 List of running conditions for all slides To get an overview of all instruments main running parameters and quality check status click The table lists average incubation details for all slides in the database e Average incubation temperature gas concentration and flow e QC status and comments to the QC Slide ID Instrument Slide Patient ID Start Temperature C02 Conc C02 Flow 02 Conc N2 Flow QC Comment D2010 05 25 50130 1007 7 130 2456 2010 05 25 14 06 37 019 5 351 0 145 4 573 2 373 Approved D2010 05 25 501311007 7 131 5673 8954 2010 05 25 14 07 37 136 3 963 3 870 8 665 24 561 Approved D2010 05 25 501321007 7 132 4562 8654 2010 05 25 14 08 37 136 3 963 3 870 8 665 24 561 Approved D2010 05 25 50133 1007 7 133 2457 8754 2010 05 25 14 25 37 155 3 731 4 508 8 665 24 561 Approved D2010 05 25 50134 1007 7 134 4631 9535 2010 05 25 14 26 37 155 3 731 4 508 8 665 24 561 Approved D2010 05 25 50135 1007 7 135 4710 9271 2010 05 25 14 27 37 156 3 639 4 808 8 665 24 561 Approved D2010 05 25 50128 1007 7 128 547689 543275 2010 05 25 13 20 37 012 5 302 0 078 Approved D2010 05 25 50129 1007 7 129 125648 875367 2010 05 25 13 29 37 014
51. n EmbryoScope relative to fertilization time e Instrument and slide number e Runs Number of times images have been taken of the embryos e Annotations Information embryo annotation status e Number of embryos selected for transfer from the slide and list of the wells e Pregnancy outcome data e Slide type e Annotation comment and QC status Page 49 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 Slide ID Monday 31 May 2010 22 08 Patient 1D Patient Name Treatment Fertilization Start End Instrument Slide Runs Annotations Transferred Wells Gestational Sacs Fetal Heart Beat Slide Type Instrument QC Comments D2009 10 20 S0080 1011 10203040 Linda Crown 1001001 2009 10 20 13 00 2 92 71 20 11 80 203 Annotated 1 wi 1 1 Human Clinical D2009 11 05_S0052_1018 10203050 Jessica Geithner 1001002 2009 11 05 1 00 1 44 96 73 18 52 528 Annotated 2 WSW6 1 1 Human Clinical Annotation cd D2009 11 17 50109 1011 P10203060 Ursula Hansen 1001003 2009 11 1712 00 484 7172 11 109 198 Annotated 1 we 0 0 Human Clinical D2009 12 01 50119 1011 P10203070 Birgitte Nielsen 1001004 2009 12 01 12 00 3 48 70 91 11 119 201 Annotated 2 w1w2 lo 0 Human Clinical D2009 12 06 51013 1004 10203080 Mary Jones 1001005 2009 12 06 14 00 2 52 114 90 4 1013 325 Annotated 2 w3 we 2 2 Human Clinical D2009 12 11 1030 1004 10203090 Elizabeth Thompson 1001009 2009 12 10 13 00 20 29 117 96 4 1030 290 Annotated
52. n Granular pen Granular leo lE 1 Bl a a sR CU en V Zona pelucida defect Zona pelucida defect Zona pelucida defect comment Ff emet EE c Comment annotation list 6 3 1 Using the annotation table When a specific annotation is done the time and value are written in the list of annotations The various annotations are described below Cell division L ITUENENINEMNNG Division chart Number of cells Blastomere activity Cells Visible nuclei es T Visible nuclei 1 ux 0 Time Stage Value Ss l l 3 IN Dynamic Score Z Score Morphological Grade e Scores gra d es 4 normal 5 18 8 1 true Blastomer Size Pronudei Pronuclei 1PN 2PN 3PN 4PN 433 7 2 Even Division E4277 l lt _ Fragmentation 0 10 10 20 20 50 50 100 139 3 List of Haz sao 5 Multinudleation 0 cell s out of 1 cells lt Multinucleation annotations L s4s 6 55 7 7 Naked Irregular Division 57 5 8 i L 7 Ovoi Dynamic Score E Blastomere size 365 2 E Granular Even G Fragmentation j D Uneven L 1337 2 0 10 Morphological Grade 136 5 2 5 Comment L 5 Page 35 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 6 3 2 Cell divisions Cells 2 zz The tool for annotating cell divisio
53. n the View Slide page If an attempt is made to update or leave the page before saving a dialog box will appear asking whether or not the user wants to save the changes before proceeding 6 1 10 Selecting embryos for annotation An embryo can be selected by clicking on the image on the slide The dark blue bar to the left will be highlighted in a light blue colour One two or three images can be selected and subsequently displayed on the Annotation page 6 1 11 Shortcut Double clicking on one of the embryo images opens the Annotation sheet with the chosen embryo 6 2 Timeline When clicking the button the embryos within the specific slide are shown at pre specified time points The page gives a fast overview of the embryos in the slide Embryos that should be discarded can be selected and not be shown on the page leaving more space for the prevailing embryos that can be selected for transfer freeze or further observation In addition it is possible to magnify the small images in the Timeline Page 29 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 9 5 z z 3 AAAA PEE EIE EIEIEIEIE DADAR P mamae Timepoints shown Z v x 4 Update 30 Don t show discarded 6 2 1 Choosing displayed time points Preferred time points
54. ns on the division chart works in the same way as the tool on the View Slide page section 6 1 3 6 3 3 Visible nuclei Visible nuclei EM o Em The number of visible nuclei can be annotated by clicking the plus or minus sign until the number in the box matches the number of visible nuclei on the embryo image Synchrony or asynchrony in the appearance and disappearance of nuclei can be annotated using this tool 6 3 4 Dynamic score Z score and morphological grade Dynamic Score zZ Score Morph Grade e Dynamic score can be used as an overall score where the time lapse information has been used in determining the grade e Z score can be used for grading the pattern of the pronuclei and the pattern of the nuclear precursor bodies in the pronuclei e Morphological grade can be used as a grade based on the timeline images the morphological grade can also be assigned on the Timeline 6 3 5 Pronuclei Pronuclei 1PM IPN 3PM FPN Number of pronuclei before first cell division can be annotated 6 3 6 Fragmentation Fragmentation 0 10 10 20 20 50 30 1005 The relative degree of fragmentation of the embryo can be annotated Page 36 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 6 3 7 Multinucleation zh Multinucleation 1 cellis out of 2 cells The number of cells in which multinucleation is observed can be annotated 6 3 8 Blastomere size and other properties Maked Irregular Division Ovo
55. nt and Dead for atretic embryos The color code on the division chart is Green 1 2 4 8 cells Yellow 3 5 6 7 cells Blue M B EB HB Red Dead A division pattern can look like this Page 26 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 6 1 4 Blastomere activity 10 Dynamic Score EF 1 Ws Blastomere activity Image series are analyzed automatically in real time with the EmbryoScope software Blastomere activity is a numerical parameter that reflects the amount of movement that has occurred between two consecutive images in the time lapse image series The blastomere activity has NO DIAGNOSTIC USE but can be used to assist the user in identifying periods in the time series where events of interest may be occurring Peaks in the blastomere activity often occur when cell divisions take place since the cell divisions lead to movement in the image An example is given in the image above There can be other causes for peaks in the blastomere activity than cell divisions 6 1 5 Dynamic score The Dynamic Score abbreviated Dyn Score can be annotated in the Annotate sheet and if annotated it is displayed to the left of the image 6 1 6 Embryo selection buttons Page 27 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 Buttons for marking selected embryos are listed in the panel below the images J l bg 2 e The x button marks embryos s
56. nts panel switches the middle box between the different treatments Click ses creates a new treatment which can be linked to a slide using the bottom slide box see section 5 2 11 5 2 3 Printing slide label Click prints a slide label with a barcode and patient name and patient ID In order to print the slide label before the slide is started on the EmbryoScope the patient needs to be created on the View All Patients page see section 5 1 2 If the patient ID is too long for the barcode a warning message is shown instead of a barcode 5 2 4 Treatment information In the treatment box middle box detailed information about the treatment can be specified The blue header bar shows the treatment name All new treatments are named Unknown until renamed by user The grey drop down boxes has predefined values whereas the white drop down boxes is editable and the user can write in information Values previously written in the white drop down boxes are shown to make input faster Treatment Treatment 01 Medication Oocyte Culture Outcome Medication Protocol Oocyte Source Media Type HCG Test Abortion Slide s in this treatment Short Agonist Autologous Universal Positive y No D2010 04 07 50170 I006 j 2010 01 12 50143 1006 D20 Medication Brand Oocyte History First Medium Brand Gestational Sacs Abortion Comment Unknown Fresh Unknown X 2 Triggering Ooc
57. oaded to nisense Fertlli Tech A S 5 5 Isi iie dtt A Siete etl d cb aule oce evt oen o use en e ee DRE 57 8 3 2 Patient information uploaded to Unisense FertiliTech A S eeeeeeeeeeeenn nne 58 AcknowWwleagemellts sd oie pr esa dam valves Fo aros VeL DI PEL E SPUR re ERU VEA CMM cee ese 59 Disposal Of Waste sais exit adn e a Cui Uu E VE EN YR RR AR YE KO C XE ETE A Lv c d E 60 rop e A Q M M 61 Contact InfOFrmoallOn suas ova aae eua rev d ETN DONE QNA Usu Qua tac ORI dIrdUE TER REOR EEVUM QU ME EU pS 62 Page 6 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 2 Quick guide The main navigation tool in the EmbryoViewer is the navigation panel left part of the screen The navigation panel is fixed on all pages allowing for easy navigation between different functions and views The manual is structured according to the functions buttons in the navigation panel 2 1 Overview of functions in the navigation panel Running w Running instruments View Running 2 View all running slides from all connected EmbryoScopes Patients 3 Patient information Patent Name Kate Conner u gt Patient Name Patent ID 1234 5678 gt Patient ID View all Patents ES eo Lists all patients including patient details gt Shows detailed patient information including e g diagnosis medication and outcome data
58. on adjustment and wiring of the EmbryoViewer can only be carried out by a certified Unisense FertiliTech A S employee e The EmbryoViewer shall remain at the location where it was installed by a Unisense FertiliTech A S employee and may only be moved by Unisense FertiliTech A S personnel or upon explicit authorization in writing Page 3 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 Table of contents 1 2 IMPORTANT restrictions and WAPNINGS cccceccccccsceccccecsceccccececececcececececcececscescececscescscecececens 2 aIVITa Golrilo M M 7 2 1 Overview of functions in the navigation panel s ssssssssessessossscsessosoeosessosoeosessosososessosssoseseo 7 2 2 Association between different ID S seeds k ono Pub eR OR oA RON NE EAR PRRRR RM AgU E RT PE RU eR REEL EAS PENNE AR Une das 8 2 3 COIOUT ullos EO ES 9 2 4 View time lapse and score embryos ccscscscsccscsceccccscsceccccscsceccccecscssecsccscscessecscsceceececscesess 9 241 nme lapseofal smbtyOS stie to ER ET I D Eth do MERE ei enti t tetie b vetita ier m NIE Iud V 9 2 4 2 Time lapse image series of a single embryo ccccssssecccccesseccccceseeceeceeeeeecessaeececseaseceeseuaseceessueaeceeseseees 10 24 3 hmesapse ofseveralselected eblVOSuseosuuedeesuev ois es a Eve eu bh au ode aet Peto dee tbi eau iv deme pdt 10 2 4 4 Embryo development at specific time points ceeccccccssssscccccess
59. ormation to Unisense FertiliTech A S 58 Using the annotation chart 35 Video 43 View a single embryo time lapse video 10 View all patients 17 View all slides 49 View all videos simultaneously 9 View embryo development at specific time points 11 View running 14 View slide 23 View time lapse and score embryos 9 View time lapse of several selected embryos 10 Viewing 24 Viewing different focal planes 25 33 Viewing patient details 19 Viewing patient treatment information 20 Viewing running slide 15 Viewing time lapse buttons 24 Viewing time lapse mouse 25 Viewing time lapse right and left arrows on the keybord 25 Viewing time lapse scrool wheel 24 Viewing time lapse embryo development in Annotate 38 Visible nuclei 36 Zoom of graphs 40 Page 61 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 12 Contact information Unisense FertiliTech A S Tueager 1 DK 8200 Aarhus N Denmark Telephone 45 8944 9500 Homepage www fertilitech com Support available 24 hours all days In case of emergency call our free service hotline for support 45 7023 0500 UNISENSE FERTILITECH Page 62
60. r 3 0 User manual v3 0 8 1 1 EmbryoViewer software version Below the backup and data upload boxes the version number of the EmbryoViewer software is shown 8 1 2 Slides for data agreement If the Fertility Clinic has signed a Slides for Data Agreement a check box can be clicked Show Slide for Data This enables an easy overview on the View All Slides and Patient Details pages of the number of slides where the conditions for slide cost reimbursement are fulfilled View All Slides and of the amount of data necessary to upload to fulfill the Slides for Data Agreement Patient Details On the View All Slides page all slides where the Slides for Data Agreement conditions are fulfilled are colored green Slide ID Patient ID Patient Name Treatment ID Fertilization Start h End h D2010 04 07 50170 I006 1254_5676 Ann J Donaldson Treatment 01 2010 04 06 12 00 25 73 25 90 D2010 04 07 50171 1006 1234 5678 Ann J Donaldson Treatment 02 2010 04 06 12 00 26 14 25 51 On the Patient Details page all information that are necessary to provide by the Fertility Clinic to fulfill the Slides for Data Agreement are colored red and when the information is inserted the text is colored green see examples below Treatment Treatment 02 Medication Oocyte Culture Outcome Med
61. se are empty and can be used for subsequently writing in initial name of the person who performed the embryo selection transfer and freeze Slide Description Pre equilibrated 18 h Selection by Date Time Transfer by Date Time Freeze by Date Time Page 44 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 The report shows the last image of the selected and frozen embryos and a diagram of the slide indicating the position of the selected and frozen embryos At the top of the report patient name patient ID treatment ID slide ID fertilization method and date of report printed are shown Instrument Data Patient Information Patient Name Ann J Donaldson Report Written 2010 08 13 Patent ID 1234 5725 Treatment ID Treatment 01 Slide ID ID20 10 07 07 50225 I016 Fertilization Method icsi j Well Embryo ID Embryo Description Morph Grade Dyn 5core Selection 1 1 Container 1 5 7 straw 1 Freeze z l2 Container 1 5 7 straw 1 Freeze 3 3 Discard 4 l4 Unknown 5 5 Discard 6 6 Container 1 5 7 straw 2 Freeze 7 z Discard 8 8 Unknown 9 E Transfer 10 10 Unknown 11 11 Discard 12 12 Transfer Freeze Slide Description oocytes after icsi from day 0 to day 5 6 Selection by Date Time Transfer by Date Time Freeze by Date Time Page 45 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 6 6 2 Instrumen
62. t data The instrument data sheet shows a table of average min max and standard deviations of temperature and gas conditions Temperature and gas conditions are also shown graphically Quality check status and initials of the QC person are also shown on the report This report can be enclosed in the patient journal At the top of the report patient name patient ID treatment ID slide ID and date of report printed are shown Laboratory data Instrument Data Patient Information Patient Name Julie Jansen Report Written 26 05 2010 Patient ID 1234 9876 Treatment ID 1 treatment Slide ID D2005 09 08 50048 I011 Treatment Micromanipulation Mormal IVF Medication protocol Media type Lniversa a 37 4 M Temperature gar V CO2 Conc m 37 0 ve CO2 Flow c 368 IM CO2 Pres CO2 Concentration 95 and F low I 180 eunzsadg ZH amp sep G sep S sep S sep sep S sep 10 sep 1 sep Incubation averages Variable Unit Average Min Max StdDev E E Temperature 37 04 37 02 37 05 0 00 e CO2 Concentration E 3 48 2 16 3 93 0 02 CO2 Flow L h 0 29 0 16 3 68 0 24 COZ Pressure bar 0 44 0 42 0 45 0 00 QC Name QC Status Not Checked Page 46 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 6 6 3 Patient information The patient information sheet includes several images of transferred embryos and a single image of the frozen embryos At the top of the r
63. tion and a comment space related to abortion e g the type of abortion can be written in the comment space 5 2 9 Multiple slides with a treatment All slides associated to this treatment are listed in a panel in the right side of the treatment box Slide s in this treatment D2010 04 07_ 0170_1006 The blue highlighted slide is the slide shown in the bottom box Clicking on different slides in the Slide s with this treatment panel switches between the slides shown in the bottom box NOTE It is essential that the correct patient ID is chosen on the EmbryoScope if a new slide is added to an existing patient 5 2 10 Slide information In the bottom slide box information related to the specific slide are shown and it is possible to associate or move slides between different treatments Information from the EmbryoScope on fertilization date and time are shown Fertilization method and a comment can be added In the right side of the slide box a panel listing embryo specific information Embryo ID selection and description from the EmbryoScope is shown Page 21 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 Slide ID D2010 01 12_S0143_1006 Fertilization gt Well EmbryoID Selection Well Description Slide Treatment ID Fertilization Date Treatment 01 X 2009 05 11 Slide Description Fertilization Time hh mm Pre equilibrated 18 h 11 15 Fertilization Method ICS
64. ton or frame View All Patients Selected active button or frame Report Disabled button appears dark blue when the function can be used 2 4 View time lapse and score embryos A quick guide on how to view time lapse videos and score embryos is presented below For a more detailed description and explanations of all functions see section 6 2 4 1 Time lapse of all embryos View Slide Click and images of all embryos in the active slide are shown Friday 28 May 2010 17 39 EE Running Fimspeed Normal ix e bx Le id ai uu 4 b gt gt Play the time lapse images using x gt gt or the scroll wheel Select embryos for transfer freeze discarding or later decision using x f marking the embryos green blue red or yellow Page 9 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 2 4 2 Time lapse image series of a single embryo To view a single enlarged embryo time lapse film select the embryo by double clicking on the embryo frame Detailed annotation tools appear for more information on the annotation tools see section 6 3 Jed iiis ws LeeL 2 4 38 Time lapse of several selected embryos Select 2 or 3 embryos in the dark blue frame turns light blue when the embryo is selected and click Ame ef All selected embryos are shown including the annotation tools 2 m 1a ae Cels sbie nude 4 0
65. ured red View Running To check the alarm type click ELTON Below the slide boxes a red bar indicates whether it is a temperature CO O alarm or an alarm indicating that the connection between the EmbryoScope and the EmbryoViewer is lost time for last reading alarm Temperature 13 5 Paused Last Reading Page 15 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 For detailed information on how to handle the alarm on the EmbryoScope consult the EmbryoScope user manual When the alarm in the EmbryoScope stops because the parameter causing the alarm is back within accepted range the red alarm bar both on the title bar and on the specific parameter changes to yellow to indicate that an alarm has occurred Temperature 37 1 C No slides Last Reading 15 12 When the alarm has been reset on the EmbryoScope the colour on the title bar and on the specific parameter changes from yellow to grey Page 16 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 5 Patients Patients 9a gt Patient information Patient Name Kate Conner q gt Patient Name Patient ID epe 4 Patient ID Lists all patients including patient details Shows detailed patient information including e g diagnosis medication and outcome data This part of the EmbryoViewer allows the user to navigate throu
66. ytes Aspirated Second Medium Brand Fetal Heart Beat HCG 12 Unknown 2 m Total FSH Dose IU Sibling Embryos in Standard Incubator Media Change Live Born Babies LH Supplement No 7 None 2 Comment Comment 5 2 5 Medication In this box information related to the medication used in the patient treatment are typed in i e medication protocol medication brand type of triggering total FSH dose checkbox for indicating LH supplement and a comment space related to medication Page 20 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 5 2 6 Oocyte information In this box information related to the oocyte are typed in i e oocyte source autologous donor other oocyte history fresh thawed other and number of oocytes aspirated If there are embryos from the same treatment that is incubated in a standard incubator the information should be specified in the sibling embryos in standard incubator box 5 2 7 Culture conditions In this box information on the embryos culture conditions are typed in i e media type brand of the first and second media whether a media change are performed and a comment space related to culture conditions 5 2 8 Outcome In this box the outcome data is typed in result of the HCG test number of gestational sacs number of fetal heart beats observed number of live born babies information of abor
67. zes be fu ee 39 6 4 IncubatiOl o ote o eve Un a ivi Eie o a uia di be OM P eU 39 6 4 1 INSPECTION OF MUNMINE Conditions istis aevi tre Mesi taii tdsui es bees uut tout Ic i PuuuS Menlo ei estuvo dui estt au E oen 39 DUL2 ZO ORIOL CUD INS once opi parce n OUR ed d iacet iic tu farce ege ea does Vates ie br fax uu Cas om tence tis va vet D teo esee qe c cR MEE 40 6 4 3 Detailed runmims Inreristiofixssteteeus dtes en onte avene dl dave eol Las eM ccu E p LU CC cuis 40 OAA SUMMALY SICCE scdecsaveces olul vance redeo eode dt eue ved M vad corse aeui eoe Eod isa testet bod edere M madonna 41 GAS Warnes SNe Eea p pv vett MEME gs esta ee 41 ero S NS NOS SIC ase TT M 41 64 7 The Other shet us necessa IoISTO FU AEE E a Pepe ecu std dad udtot se Hes pu S odes uv Ru Uva Ua oa soreness 42 648 Save OC status and COMMEN sssescchi ine osa epa PE RR CAREER a a 42 6 5 Mero RR 43 6 5 T Generate video oFembPyols sousbieitentteiut at bat idu iaa tala bebkdsEdve tos bsk itn oi Gabe ubi Mese tad ubi to mud eos sab iioi ime be tudu E tees 43 6 5 2 Generate embryo IMAC es cucumber it e M mara mter Rc pe laeiiqus 44 6 6 REDO RT TD TI ETUR 44 6 6 1 Laboratory dala NEM OO OL Um 44 6 6 2 Instrument oq RH 46 Unisense FertiliTech A S EmbryoViewer 3 0 User manual v3 0 7 8 10 11 12 6 6 3 PE He AN MUL AIA 816 F Ae id RTT ER 47 6 6 4 PIU CD OGUS e Mec 48 DOU

EmbryoViewer EmbryoViewer ryoViewer™

Contents

Download Pdf Manuals

Related Search

Related Contents

EmbryoViewer EmbryoViewer ryoViewer&trade;

Contents

Download Pdf Manuals

Related Search

Related Contents

EmbryoViewer EmbryoViewer ryoViewer™