EmbryoScope™ Embryo Monitoring System
Contents
1. are chosen the possible minimum cycle interval will increase Likewise a large number of focal planes will result in longer cycle intervals Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Software version 2 3 2 0 Images Settings Number of Image Focal planes Increment um 7 n 15 NOTE a high number of focal planes increases the minimum cycle interval Cycle interval min 20 Camera Exposure Memory use full slide 6048 Images d Approx 151 MB d Time t xt Cycl 3 It is possible to change all of the above parameters during a run However it is highly recommended that adjustment is only carried out between runs Error Conditions If an error condition is detected the corresponding button will turn red and an audible alarm will be activated Paused au ER mn No O gt viewer setting When the conditions have returned to normal the button will turn yellow to indicate that an error condition has occurred More information about the error can be obtained by touching the button Image Processing mage Frocessing 37 0 No O2 Viewer Settings Slide 6 Well 10 l l Reset the alarm by touching the yellow button to go to the corresponding screen and touch the Reset Alarm button 39 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 22. 3 Cleaning Check 5 1 14 16 00 14 17 00 14 18 00 14 19 00 14 20 00 14 21 00 14 22 00 14 23 00 14 24 00 14 25 00 14 26 00 14 27 00 Check gas concentrations by opening the top lid 44 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 2 Temperature check Open load door The temperature is validated with a calibrated temperature sensor inserted into slide holder according to the training procedure Any certified temperature sensor with proper sensor dimensions may be used according to the manufacturer s guidelines However a special hole in the EmbryoSlide holder is designed for use with a minisensor YSI 4611 probe for the YSI 4610 precision thermometer A procedure for the temperature check which is used as part of the routine service checks by Unisense FertiliTech A S personnel exists as WI 7 7 68 EmbryoScope Temperature Test Temperature Incubator Check 1 Gas Check J Temperature 3 Cleaning Check 14 16 00 14 17 00 14 18 00 14 19 00 14 20 00 14 21 00 14 22 00 14 23 00 14 24 00 14 25 00 14 26 00 14 27 00 Check the temperature by measuring the temperature in the slide holder 45 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 3 Cleaning check Open load door The slide holder and embryo chamber are inspected to ensure that no particles or liquid residuals are visible The slide ho
3. Embryo Monitoring System Version D User Manual 2010 version 2 10 Information Slides can now be removed c Start will start a new time lapse imaging run with up to six slides Everything is now ready to start a slide with time lapse imaging Press Start the display shows the main screen All six slide positions are dimmed as no slides have been added For more information about the main screen and adding slides see the section Start time lapse imaging on page 22 Slide 1 Slide 2 Slide 3 Slide 4 Slide 5 Slide 6 Empty Empty Empty Empty Empty Empty No Slides 37 0 No CO2 No O2 Viewer Settings 20 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Preparation of EmbryoSlides EmbryoSlides FT S ES D FT L ES D Unique EmbryoSlides have been developed for the cultivation of embryos while in the EmbryoScope References e FT S ES D EmbryoSlide for cultivation of embryos e FT L ES D Lid for EmbryoSlide Description of EmbryoSlides An EmbryoSlide contains a large oil reservoir with 12 wells for single incubation of 12 individual embryos Each well has a volume of 25 ul Inside each well there is a central depression where the embryo resides 1 e the micro well with a diameter of approx 250 um Well Reservoir Micro well Individual well numbers are indicated beside the bottom of each well Th
4. 10 Reset Alarm All error conditions are written to all active slides data files Pausing a Slide In case a slide needs to be temporarily removed e g for media change or inspection in a microscope use the following procedure 1 Select the slide tab you want to pause for inspection Slide 4 test 2 LFN Slide 5 test Patient Description v Fertilization 11 nov 2009 12 00 Run 6 Home 37 0 COJI No O Viewer Settings 2 To remove the slide from the EmbryoScope and subsequently re insert it for further measurement simply touch Pause 40 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 3 Touch OK to move the slide to the loading area where it can be removed Confirm Remove slide 1 for miroscopy Prog ram paused Wating for slide 3 to be re inserted Patient ID test Patient Name test End Slide Re Insert UNISENSE FERTILITECH To re insert the slide and press Re Insert the device will then re focus on each well 4 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 1 Touch End Slide to permanently remove a slide You are asked to confirm Warning End slide 1 Touch OK the slide is moved to the loading area where it can be removed Information Slide 1 can now be removed 2 Insert a USB
5. Even though the EmbryoSlides did not contain any bubbles before the onset of equilibration bubbles might have formed during the equilibration period It is important that EmbryoSlides are inspected for bubbles microscopically before embryos are loaded All bubbles in both wells and micro wells that might have formed during equilibration must be removed This is crucial as bubbles will prevent image acquisition Bubbles in the larger part of the wells can be removed by gently pushing it to the surface using a pipette tip When bubbles have reached the surface they should be removed by gentle suction Loading of Embryos e Place an embryo in each well We recommend using Stripper tips MXL3 275 from MidAtlantic Diagnostics Inc for safe loading of embryos into the EmbryoSlides Due to the special geometry of EmbryoSlide the embryo will naturally migrate to the narrowest point of the well the micro well Take care not to add too much medium when loading the embryo Use an inverted microscope to verify that the embryos are correctly positioned at the bottom of the micro well e Slides can be placed directly into the EmbryoScope and image acquisition can be started immediately after embryos have been loaded into the EmbryoSlides 23 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Start Time Lapse Imaging The EmbryoSlides have to be prepared in advance as described
6. add more slides Question Add more Slides If you answer Yes the software will repeat steps 3 11 If you answer No the program will take images of each well and find appropriate focal planes Finding Wells and Focal Planes for Image Acquisition The program will automatically try to find the wells in each slide and the most informative focal planes to acquire images of each well It will take approx 3 minutes to find the optimal focal planes for all of the wells in a fully loaded slide 27 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Autofocusing Slide 6 Well 2 Increase Search Check Slide Autofocusing Slide 6 Well 2 Increase Search Check Slide 28 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Once all wells and focal planes have been found the home screen is presented again with large buttons slide tab representing each slide Slide 1 Fertilization 10 nov 2009 12 00 Run 143 Time Since Fertilization 1d 23h 37m Fertilization 10 nov 2009 12 00 Run 142 Time Since Fertilization 1d 23h 42m Slide 3 Fertilization 10 nov 2009 12 00 Run 141 Time Since Fertilization 1d 23h 21m Slide 4 Description Fertilization 09 nov 2009 12 00 Run 141 Time Since Fertilization 2d 23h 24m Slide 5 Fer
7. device is working correctly The device should never be moved or disconnected by unqualified personnel Installation requirements e Clean room with stable temperatures between 20 and 30 C e Sturdy table with approximately 1 0 x 0 6 m bench space e Uninterrupted power supply 110 230 V max 120 W with proper grounding e Specification of attachment plug for connection to the alternate voltage NEMA 5 15 Hospital grade related current and voltage 15 A 125 V AC e CO gas supply with pressure regulator capable of providing stable input of CO at 1 atm above ambient e N gas supply with pressure regulator capable of providing stable input of N2 at 1 atm above ambient NOT required when incubating at ambient O2 concentration e Medical Electrical Equipment requires special precautions regarding EMC and has to be installed and put into service according to the EMC information provided IMPORTANT NOTE In case of room temperatures above specified limits the embryo chamber has no cooling function and will reach at least ambient temperature Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Device Parts Service lid Pull out Keyboard Unpacking and Setup of EmbryoScope The recipient end user of the device should NOT unpack and install the device upon receipt The EmbryoScope MUST be installed and tested on site by certified Unisense FertiliTech A S personnel T
8. o2 r regulation of O2 concentration on off adjustable hu C current humidity in current adjustable Co2 F current CO gt flow rate in L h current fixed n2 F current N gt flow rate in L h current fixed 1232 RS232 interface on do NOT change tunE Re calibrate internal temperature sensor adjustable int t base value for PID controller do NOT change ti St setting internal time of the incubator do NOT change St St Start Set device startup ttme do NOT change hEAt start incubator at startup time off do NOT change A St automatic start every weekday off do NOT change hour show time on display off do NOT change ul Constant UV lamp in airflow on adjustable u2 Second UV lamp not installed rESt Reset all parameters to factory values do NOT reset vEr Incubator software version current After changing one of the adjustable values press the up arrow multiple times to return to the current temperature Exit the menu by pressing the up and down arrows simultaneously for 3 seconds 14 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Lock Incubator Panel In order to lock the incubator panel to avoid unwanted changes or shutdown of the incubator ei Press alarm touch pad GS and up arrow tap simultaneously to enter the Lock mode G Ga To exit Lock mode pr
9. 10 Live Inspection of and Refocusing on Embryos It is possible to inspect any embryo during a run by pausing the automatic image acquisition to obtain a live view of the embryo with full control of the focus motor positioning and image acquisition shutter speed etc When refocusing it is possible to manually re position the embryos so that the acquired images are centered on each embryo The user can also select the focal plane which will provide the most informative images about the embryo development Procedure for refocusing and live inspection 1 First select the slide you want to inspect on the Home screen by touching the slide button and select the well to inspect by touching the respective image Slide 5 test Patient Description v Fertilization 11 nov 2009 12 00 Run 6 Home Image Processing 37 0 CO3 5 1 No O2 Viewer Settings Slide 2 Well 6 2 Click on the Live button The device moves to the selected slide and well and focuses on the midpoint of the image stack 32 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Video Live Slide 5 Well 5 tect Fertilization 11 nov 2009 12 00 Patient Description Embryo Description New Focus Increment um EN e Q I I 00S 0001 EU Focus 1030 h If the embryo is out of focus touch the up or down arrow resp
10. EmbryoScope Embryo Monitoring System Version D User Manual Version 2 10 Caution Federal law restricts this device to the sale by or on the order of a physician or a practitioner trained in its use ETL CLASSIFIED LE 0543 ISTE 3184651 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Indications for Use EmbryoScope To provide an environment with controlled temperature CO and other gases for the development of embryos This model has an integrated inverted microscope and imaging system for embryo viewing Device use is limited to three days 72 hr covering the time from post fertilization to day 3 of development EmbryoSlide Preparing storing and transferring human embryos To be used only with the EmbryoScope device The procedures described in this manual concern a particular Medical Device installed by Unisense FertiliTech A S personnel at a designated location The EmbryoScope Version D in the following called EmbryoScope D MUST be operated by trained personnel according to instructions contained in this user manual This product fulfills the requirements of the UL 60601 1 and IEC 60601 1 standards class I type B equivalent The device is suitable for continuous operation Medical Device Directive The EmbryoScope D and related accessories conform to the requirements of the EU Council directive 93 42 EEC concerning med
11. Scope into the Embryo Viewer workstation the experimental data can be uploaded to the Unisense FTP server for validation The patient name is NOT uploaded Only the patient ID Remove EmbryoSlides after Crash 1 Turn on EmbryoScope main switch green switch rear side upper right corner 2 When everything has been initialized and the welcome screen appears choose Remove Slides Emergency Removal of Slides The safest way to terminate a running experiment is described in the section End a Running Slide on page 44 of this manual However in case of an emergency a running experiment can be terminated IMMEDIATELY by performing the actions described in the Emergency Removal of Slides procedure The Emergency procedure can be found in a pouch attached to the underside of the Service Lid 1 Remove Service Lid Large lid above the Touch Screen Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 2 Emergency procedure can be found in the pouch below The label on the pouch show a list of the operators at the installation site that have been instructed in the emergency procedures The names and mobile phone numbers of these operators are listed on the labe attached to the pouch 3 The Pouch also contain an Allen key that may be used to retrieve the Slideholder if it is in an unfavorable position when the power was turned off See Emergency man
12. Therefore it is necessary that the operator of the device is properly trained by Unisense FertiliTech A S employees The standard procedure for installation is e Day 1 EmbryoScope D setup complete check of all device functions overnight run with empty EmbryoSlides prepare EmbryoSlides for day 2 full day approx 8 hours e Day 2 Instructions restart EmbryoScope D load slides with mouse embryos start experiment and discuss feedback during run prepare slides for day 3 full day approx 8 hrs e Day 3 Trial experiment by trainee evaluate overnight run shut down EmbryoScope D restart start experiment with surplus discarded embryos from IVF clinic full day approx 4 hrs e Day 6 Evaluation and data transfer discuss the two runs pitfalls artifacts and possible solutions post processing of data half day approx 4 hours A second visit by Unisense FertiliTech A S employees should follow no later than three months after installation to re calibrate the device and verify that it is operating properly The second visit will usually last two full days Subsequent visits are covered by the service plan which usually involves at least a full day visit every six months Device Installation The EmbryoScope D is installed and tested on site by certified Unisense FertiliTech A S personnel During installation extensive tests and calibration of the device are performed to ensure that the
13. U EINE eer 30 ee 30 Live Inspection of and Refocusing On EMDIyOS ccccccccccssssseseeececececaeeeeseeecceeeessaaaesseeeeeees 32 Memperature CO7 Oxanda EELER Eege AEE EE 35 Enor C ondi oN E 39 NEIE 40 Periodic Validation Check Dy End User ssssscccccssssssscccsssssssccccccsssssccccccesscsccccssssssscoees 43 Sne V alt aniOn Check Seeron eres antes ete nd gee auee ean aneaa eased anaes 43 EE e 47 Emkrees eegene 49 Close Proerain Of COMpUter E 49 B Fe sl Upload E 50 L adins Data into the NEE ee 50 Remove EmbryoSlides after Cras Wisssssissciesvassisssascniontasanusascdscessavasssccsdvcstausssannsasl cesesescateass 50 Emergency Removal OL SHGES vicssds cesccesssescasdesdecsescdescdscesebecedeses vedesteasssseesddadsssbeussoussiveteatecssssees 50 Ei ASC Oo ENEE sissa NE E E 52 IRC ne E 52 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 General Overview The EmbryoScope D is a tri gas embryo incubator which acquires a series of unattended measurements on individual embryos during their development The measurements include time lapse microscopy at multiple focal planes and logging of incubation conditions Separate processing units control the incubation environment and the data acquisition to ensure safe and reliable operation Features e High resolution time lapse image series at multiple focal planes e Automated detection and focusing of
14. aces of the device 2 Following cleaning leave the load door of the unit open to allow sufficient time to ensure that all alcohol fumes have dissipated 3 Finally purified or sterile water is used to wipe the device surfaces Disinfection of the device Wearing gloves and good handling techniques are important to successful cleaning In case of contamination and or spillage the slide holder is removed To remove the EmbryoSlide holder first terminate all running measurements by ending each slide individually Check on the Home screen that all slides have been removed Proceed with the following steps as shown during the on site training program as part of the installation procedure l Close computer by touching End on Home screen 2 Power off EmbryoScope on rear panel 3 Open load door 4 Remove glass plate covering the inaccessible positions on the slide holder Lower the load door slightly now carefully lift the glass cover up and gently pull it towards you 47 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 10 11 12 Remove slide holder by unscrewing the two bolts holding the slide holder in place Pull gently towards you to remove the slide holder Clean internal surfaces and the slide holder outside the device with FertiSafe spray Follow up with FertiSafe wipes Wipe all internal surfaces and the slide holder with at least three wip
15. be reached through the load door The slide should be inserted with wells 1 5 and 9 and the handling tail towards the front 5 Touch OK 6 Enter patient ID patient name and the date and time of fertilization for the treatment A description of the particular treatment cycle or etiology can be entered in the Description box Well Camera Embryo ID Description Slide 1 oh oll b Patient ID H 111111 1111 v gt H 4 4 Patient Name 7 a 5 5 Petra Hansen v f Ra H Second cyde o G 10 No empty 11 No empty 12 No empty Date of fertilization Time of fertilization 12nov2009 08 30 7 Itis important to enter the correct fertilization time as all subsequent events such as cell divisions will be related to the time of fertilization e g the first cell division occurred at 23 5 hrs after fertilization 8 The table on the right side contains information about the individual embryos The blue camera button indicates that time lapse is acquired OK A white color indicates that time lapse is not acquired e g empty blank wells 9 Itis recommended to include a detailed description of the embryos in each well This information is saved with the experimental data in the data files and simultaneous access to this description blastomere activity greatly facilitates and accelerates data interpretation Furthermore keeping the information together like
16. e images but will not pose a immediate threat to the embryos incubated in the EmbryoScope as the temperature and gas concentration is controlled by an independent incubator CPU The computer alarm will sound in case of e EmbryoScope software failure or failure of the operating system of the built in PC e Load door open to long time gt 30 seconds e EmbryoScope software is not running properly e g in case of problems with the PC operating system or if the Scope software has accidentally been turned off e Errors in datacommunication between EmbryoScope software and the separate unit controlling the incubation environment Temperature and Gas The computer alarm can NOT be reset but require that the alarm condition is resolved e g by closing the load door properly or rebooting the computer system see section on emergency procedures 12 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Change and Inspect Incubation Values and Parameters Embryo incubation conditions are controlled by a range of parameters These parameters can be changed and their current values displayed by activating the settings mode of the incubator control panel on the front left side GOI JI Press up and down arrows simultaneously CaS to enter settings mode The display shows u Some of the parameters can be adjusted to different values by the user e g desired CO2 concentration O
17. ectively to change focal plane 4 Increment focal step size can be adjusted in the Increment field 5 When the optimal position and focal plane is visible touch the New Focus button This view is used as the new central focal plane for the following image acquisitions 6 The image may be saved in full resolution by touching the Save Image button You will be asked to specify where the image should be saved 7 If the image is too bright or too dark change the exposure time by touching Adjust Camera 33 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Slide 5 Well 5 Histogram i EU 0 50 100 150 200 250 Exposure 1 80 ms F 4 35 0 b Apply Exposure 0001 I 00S Focus 1030 Increment um Previous Well Next Well 8 The new camera settings are universally applied to all wells and slides 9 When all wells are centered in the field of view and all pictures are in focus touch Back to return to the overview 34 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D Temperature CO O and Settings User Manual 2010 version 2 10 Data on temperature and gas from the device are collected continuously These data can be displayed by touching the three lower buttons see sections below The environmental data are saved to the data files of all active slides If
18. embryos in EmbryoSlides e Incubation of up to 72 individual embryos in six sterile disposable polymer slides each with 12 embryos e g up to six patients with 12 embryos each e Built in tri gas incubator which controls temperature carbon dioxide and oxygen levels The device uses Nz and CO to maintain desired oxygen partial pressure and pH in a bicarbonate buffer system e Independent control units for data acquisition and control of incubation conditions e Air purified by HEPA and active carbon filters e Large load door facilitates cleaning and removal of EmbryoSlides in case of power failure Blastomere Activity Image series are analyzed automatically in real time with proprietary software Blastomere activity is a numerical parameter that reflects the amount of movement that has occurred between two consecutive frames in the time lapse image series The blastomere activity has NO DIAGNOSTIC USE but can be used to aid users identify areas in the time series where events of interest may be occurring No operator input is required and the output is available at any time during incubation Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Technical Specifications Incubator Capacity 6 EmbryoSlide trays holding 12 embryos each e 72 embryos in total Temperature range ambient temperature 7 C to 45 C Temperature accuracy during incubation 0 1 C betwee
19. erature 37 8 37 8 37 7 37 7 37 6 37 6 37 5 37 5 37 4 37 4 37 3 37 3 D 37 2 37 2 o 37 0 37 0 36 9 35 9 k 36 8 36 8 36 7 36 7 36 6 36 6 36 5 36 5 36 4 36 4 36 3 36 3 36 2 36 2 36 1 36 1 Set Point 37 0 36 0 36 0 06 11 07 11 07 11 08 11 08 11 09 11 09 11 10 11 10 11 11 11 11 11 12 11 12 11 Date Time Warning Paused S 37 0 CO3 5 1 No O2 Viewer Settings Again the black crosses indicate time points where the load door has been opened e g when inserting or removing slides The More button gives access to additional information about the device The top graph shows the temperature of seven different temperature sensors placed in the device The lower noisy graphs show the current consumption by various components of the EmbryoScope device and the Fan speed These tabs are primarily of interest to Unisense FertiliTech A S personnel for troubleshooting purposes 36 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Temperature Current Fan Speed Temperature M Backboard IW Power Supply M Outside W Left Top M Left Bottom W Right Top IW Right Bottom ZS 8 Temperature C 06 11 O7 11 O7 11 08 11 08 11 05 11 05 11 10 11 10 11 11 11 11 11 12 11 Date Warning 12 nov 2009 Door opened 12 nov 2009 Door closed 12 nov 2009 Door opened Back Temperature Backboard e Temperature Power Supp
20. ered in case of a system crash 1 The Slide tab above shows the latest images acquired in each well 2 The orange red graphs show the measured blastomere activity over time for each well 3 Touch the image corresponding to a given well to open the video window and obtain more detailed information about the measurements in the well 30 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Slide 5 Well 5 Fertilization 11 nov 2009 12 00 Patient Description Embryo Description Previous Well Next Well 4 The video display can play an embryo movie by pressing play 5 The position of the image in the timeline is shown by the vertical black line in the static lower left graph of blastomere activity for the well 6 When performing a playback of the movie the time lapse imaging is temporarily paused Playback of the movie is otherwise interrupted by higher priority tasks such as image acquisition or slide movement 7 Movie playback can be paused as well as stepped forwards and backwards by touching the appropriate arrows on the screen If images of multiple focal planes were recorded the current focal plane can be changed by touching the up or down arrows To go back to the overview of all wells close the window by touching the Back button 31 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2
21. es Repeat until the wipes are not discolored Change gloves and after 10 minutes contact time spray sterile water and wipe with a sterile polyester wipe Alternatively wipe with polyester wipe dampened with sterile water Repeat 6 and 7 three times Gently replace slide holder and mount it with the two bolts Tighten the bolts remember to alternate between the bolts during the tightening Turn on the EmbryoScope rear panel When the EmbryoScope has started choose Reset to proceed Follow instructions to reset device realign camera focal planes and well bottom coordinates 48 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 End a Running Slide 1 Go to the Home screen 2 To end a slide touch the slide tab at the top of the screen 3 Choose End on the selected slide tab The device will give a warning Warning End slide 1 4 Choose OK to accept you will receive the following information Information Slide 1 can now be removed Close Program or Computer Proceed until all slides have been ended separately You may now close the program by choosing End on Home screen Confirm Exit Program 49 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Data Upload Loading Data into the Viewer In connection with export of data from the Embryo
22. ese numbers are readable by stereomicroscope during embryo handling The numbering scheme used for the 12 wells are EmbryoSlides are delivered in sterile pouches with separate pouches containing lids for the EmbryoSlides The pouches should only be opened in a sterile laminar flow hood and the EmbryoSlide must immediately be covered with a corresponding sterile lid 21 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Filling EmbryoSlides with media General Each EmbryoSlide contains 12 separate wells for the single incubation of 12 embryos Each embryo is incubated in a small 25 uL aliquot of medium under a common oil cover EmbryoSlides should be filled with medium and equilibrated at least 20 hours before the embryos are loaded Following the loading of medium and oil EmbryoSlides should be transferred to an incubator with the appropriate temperature and gas conditions for equilibration It is essential that all bubbles are removed from the slides before equilibration is initiated We recommend using the procedure below Procedure for loading medium into EmbryoSlides 1 Load 1 4 ml of flushing medium in the reservoir of the EmbryoSlide We have found that the flushing medium should NOT contain human serum albumin HSA We routinely use Global Medium LGGG 020 from IVF online as the flushing medium Flushing medium should have room temperatu
23. ess alarm touch pad and up arrow simultaneously If an audible alarm is activated in Lock mode press the Reset Alarm touch pad GS to inactivate the alarm Measurement Setup An internal industry grade PC running Microsoft Windows Vista is built into the EmbryoScope Incubator D The PC controls all data acquisition motors camera etc through the program EmbryoSoft Scope D The device is started by 1 Turn on EmbryoScope D on main switch green switch rear side upper right corner 2 Make sure incubation settings of temperature gas mixture etc are as desired using the incubator control panel on the left see preceding sections 3 Wait for Windows Vista to boot the computer and the EmbryoSoft Scope D software to start automatically 4 When everything has been initialized and checked you are presented with the welcome screen 15 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Welcome Initialising Electronics Initialising Camera Initialising Incubator Initialising Motors System Initialised UNISENSE FERTILITECH Remove Under normal operating conditions you will choose the default button Start The two lower buttons on the left side are in the event that the device was not terminated correctly at a previous run The functions of the buttons are as follows a Reset calibrates the motors in the device If the program was not
24. he shipping conditions are temperature 10 C 50 C humidity 30 85 as indicated on the box label The exterior of all shipping boxes should be inspected for signs of damage during transport Should this be the case contact Unisense FertiliTech A S immediately for further instruction Unisense FertiliTech A S Tel 45 8944 9500 Fax 45 8944 9549 E mail sales fertilitech com If the boxes appear damaged do NOT open them Leave the EmbryoScope in the shipping boxes in a dry safe storage area until setup can be initiated by a Unisense FertiliTech A S service technician Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Connecting the EmbryoScope ALL connectors and sockets on the back side of the instrument are ONLY for use by Unisense FertiliTech A S in the installation procedure as described in the Service manual Operators and end users should NEVER use or attach any tubing wiring to the backside of the instrument Rear view of the instrument e y H UNISE NSE Frpmfrcu Ain Tueager 3 Du 6200 Aarhus N Danmark u i i 7 3 H k D d ih thernet Attaching and securing CO and Nz supply through the appropriate and labeled inlets must be performed by Unisense FertiliTech A S personnel Connecting the EmbryoScope and the EmbryoViewer through an EtherNet cable require a special setup and must be made by Unisense FertiliTech A S personne
25. ical devices classified as class Ia Conforms to ANSI UL Std 60601 1 Certified to CAN CSA Std C22 2 No 601 1 Unisense FertiliTech A S employees will undertake device setup and training of personnel involved in the routine operation of the device Unisense FertiliTech A S will perform scheduled maintenance and recalibration checks according to a service plan to ensure continued safe and efficient operation The end user is strongly encouraged to follow the service plan carefully to ensure error free operation of the equipment Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 IMPORTANT Safety Instructions The following safety instructions shall ensure safe and correct use of the EmbryoScope D and prevent injury to the operator and other personnel as well as damage to property You must agree to read and understand this user manual and observe the safety instructions to be allowed to operate the EmbryoScope The EmbryoScope D may only be used by qualified personnel trained by Unisense FertiliTech A S employees The EmbryoScope D may only be used with sterile disposable EmbryoSlides produced and sold by Unisense FertiliTech A S The EmbryoSlides may not be reused EmbryoSlides and EmbryoSlide Lids are sterile All handling of EmbryoSlides and EmbryoSlide Lids should take place in a sterile workbench preferably a laminar flow hood with HEPA filtered sterile ai
26. in the sections above 1 Press Start on the welcome screen to start time lapse imaging Slide 1 Slide 2 Slide 3 Slide 4 Slide 5 Slide 6 Empty Empty Empty Empty Empty Empty Add Slide The above screen the Home screen indicates that the device is ready 24 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Add Slide 2 To insert a slide for measurements Touch Add Slide Information Please insert slide 1 3 When the above dialogue is presented the LED in the load door cover will change from red to green to indicate the load door is now unlocked and may be opened Red LED indicate locked load door Green LED indicate open load door NOTE The first EmbryoScopes did not have the built in LED s in the load door cover to indicate if the load door is open or locked Applies to all EmbryoScopes with serial numbers below 100 4 Open the load door and place the slide containing the embryos in the empty position of the slide holder EmbryoScope D Place EmbryoSlide here The first slide is placed in position 1 subsequent slides will be placed in the next available slots The program keeps track of unoccupied positions and will automatically move the 25 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 EmbryoSlide arm to the next available position which can
27. itoring System Version D User Manual 2010 version 2 10 Press and down arrow simultaneously to toggle oxygen regulation on off The display should read ott when GC is pressed Press up arrow seven times to return the display to the default setting showing current temperature Change Temperature Setting of Incubator To change temperature settings of the incubator use the control panel on the front left side GIG JI 1 Press to see the current temperature setting The display will toggle between the value and the unit e g 310 and HL 2 Press SP and up and down arrows aD simultaneously to change the temperature setting to the desired level Change Gas Mixture Setting of Incubator To change gas mixture settings of the incubator use the control panel on the front left side GOI It 1 Press up and down arrows simultaneously GED to enter settings mode The display shows wm E 2 To turn on oxygen regulation a b Press down arrow six times until display shows ocr Oxygen regulation Press SP and down arrow simultaneously to toggle oxygen regulation on off The display should read DI when is pressed Press up arrow twice until display shows oc SP Oxygen SetPoint Press and up and down arrows Gap simultaneously to change the oxygen concentration setting to the desired level Press up arrow five times to return display to the default setting showing current temperature 3 To change the CO co
28. l The instrument can and may NOT be connected directly to an internet gateway ISP Connections to a resident CTS alarm system must likewise be performed by qualified Unisense FertiliTech technicians using a standard 4 wire Lemo socket labeled Alarm to connect to the CTS system The connection MUST be thoroughly tested together with qualified laboratory personnel with knowledge of the resident CTS system to ensure that ALL alarm signals are registered properly by the CTS system The Service socket is a direct socket to a Lemosa 4 wire socket on the slide holder It is ONLY used by Unisense FertiliTech A S personnel for testing and calibration purposes The External 5 wire LEMO socket on the back has been modified so it does NOT accept a standard LEMO plug The Socket can and may only be used by Unisense FertiliTech A S employees Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Device Startup The EmbryoScope D should be turned on at least three hours before use This allows temperature equilibration throughout the device Make sure that the device is grounded through the power connector gas connections are not leaking and the gas reservoir is full Check residual pressure of gas cylinders periodically Replace CO or nitrogen cylinders if the pressure drops below 40 bar The back pressure in the connecting tubes should not exceed 1 bar or drop below 0 6 bar The device ha
29. l until it 1s in the middle of the picture adjust the focal plane until the bottom of the well is visible press In Focus Calibration of camera position 1 X Y calibration d Slide 1 Well 1 OOST 2 Focus calibration Slide 1 Weil 1 0001 4 X Y Calibration Slide 6 Well I 00S 5 Focus Calibration Slide 6 Well i In Focus Focus and center the well bottom Press In Focus to proceed 18 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 a 5 Follow the software instructions and proceed with X Y Calibration and Focus Calibration of slide 6 well 1 Calibration of camera position 1 X Y calibration wf Slide 1 Well i 2 Focus calibration f Slide 1 Well I 3 Focus Calibration f Slide I Well 4 5 Focus Calibration Slide amp Well I Click on the well a 6 Follow the software instructions and finish the reset procedure Click Yes to save the new parameters Confirm eters h s been changed save before Ce oCeeclino b Remove is used to rapidly remove slides from the EmbryoScope D Press Remove to take out all six slides after removal of the glass cover This action cannot be cancelled In case of an emergency turn off the power to the device and wait 5 seconds turn the device on again and press Remove to rescue the slides 19 Unisense FertiliTech A S EmbryoScope
30. lder may be removed and cleaned outside the device if necessary Once the slide holder is removed it is easier to clean the embryo chamber A barrier will prevent any fluid from running into the inner and inaccessible part of the EmbryoScope Incubator Check Check that the slide holder has no visible dust or oil residues 1 Gas Check Ti To remove slide holder for cleaning End all running slides Close computer by pressing End on Home screen Power off EmbryoScope on rear panel Remove slide holder see manual Clean slide holder and re insert Start EmbryoScope When Scope has started press Reset 2 Temperature Check f SOO P GA FA EA 46 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Cleaning The periodic cleaning procedure is recommended for routine processing and maintenance The periodic cleaning procedure combined with the disinfection procedure is recommended for event related concerns such as media spills visual accumulation of soil and other evidence of contamination Also it is recommended to clean and disinfect the EmbryoScope immediately after any media spills Periodic cleaning of the device with no embryos in Wearing gloves and good handling techniques are important to successful cleaning 1 It is recommended that the unit is cleaned with aqueous 70 isopropyl alcohol Moisten a cloth and wipe all internal and external surf
31. ly g5 37 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D 80 06 11 07 11 07 11 03 11 Fan Speed User Manual 2010 version 2 10 Current 09 11 09 11 10 11 10 11 11 11 12 11 M Incubator M Motor M Electronics M Heat Foil Warning Door opened 12 nov 2009 09 27 Door closed 12 nov 2009 09 21 Door opened 12 new 2008 DO 231 Danar claced Temperature Backboard GN Temperature Power Supply a Fan Speed Fan Speed 1 700 1 700 Vv Fan Speed 1 680 1 680 1 660 1 660 1 640 1 640 1 620 1 620 1 600 1 600 1 580 1 580 1 560 1 560 1 540 1 540 P 1 520 1 520 amp 1 500 1 500 S 1 480 1 480 u 1 460 1 460 1 440 1 440 1 420 1 420 1 400 1 400 1 380 1 380 1 360 1 360 1 340 1 340 1 320 1 320 1 300 1 300 1 280 1 280 06 11 07 441 07 11 08 11 09 11 09 11 10 11 10 11 11 11 12 11 Warning E 12 nov 2009 i 09 28 Door opened 12 nov 2009 09 27 Door closed 12 nov 2009 09 21 Door opened 2000 DO 23 Dane claced x Settings tab Temperature Backboard Temperature Power Supply The Settings tab on the Home screen is used to change the settings for the current time lapse microscopy It is possible to change the current cycle interval the number of focal planes and focal increment The possible values for cycle interval and number of focal planes are dependant If a large number of Image Focal Planes
32. memory stick to save the data only when the EmbryoScope 1s not connected to an EmbryoViewer Station Confirm Please insert a USB stick if you want to transfer data 42 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Periodic Validation Check by End User It is strongly recommended that the end user performs scheduled validation checks at least every two 2 weeks to validate temperature gas mixture and cleanliness of the EmbryoSlide holder Starting Validation Checks Touch Check on the Home screen to be guided through the validation procedure The procedure contains the following three 3 steps 1 Gas check CO and O concentrations are validated with calibrated external sensors according to the training procedure The service lid is opened and the valve on the right side is opened to withdraw a sample from the gas sample port for analysis according to the specifications of the manufacturer of the External CO2 O Sensor Gas sample port 43 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 A procedure for the Galaxy CO2 O2 analyzer which is used as part of the routine service checks by Unisense FertiliTech A S personnel exists as WI 7 7 69 EmbryoScope CO2 measurement CO and O3 Incubator Check es 5 6 2 Temperature Check on gt CH os UOHEguUaIUOD ZO
33. n wells 0 1 C CO range 2 10 CO accuracy 0 2 Oxygen range 3 20 Oxygen accuracy 0 3 Recovery time for CO and temperature after insert of EmbryoSlide lt 5 min Alarms Temperature CO concentration CO pressure O concentration N gt pressure Load door open more than 30 sec Air flow e Recirculation gt 60 L h full purification of gas volume every 20 min e HEPA filter retains 99 97 particles gt 0 3 um e Whatman Active Cap active carbon filter Embryo images e 1280 x 1024 pixels monochrome CCD camera e Leica custom made high quality 20x 0 40 LWD Hoffman Modulation contrast objective providing a resolution of 3 pixels per um e Illumination single red LED 635 nm duration lt 0 1 sec per image e Total light exposure time lt 50 sec per day per embryo Other Power supply 110 240 VAC Frequency 50 60 Hz Maximum power consumption 250 VA Gas requirements CO and N2 CO consumption 5 CO lt 1 L h N2 consumption 5 O lt 10 L h Dimensions W x D x H 60 x 56 x 44 cm Weight 60 kg Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Device Setup Instructions and Training of Personnel The EmbryoScope D should only be operated by skilled and trained personnel To obtain meaningful and reliable data from the EmbryoScope D it is essential that the operator knows how to load EmbryoSlides properly
34. ncentration f Press down arrow once display shows Leah CO SetPoint 11 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 g Press er and up and down arrows uy aad simultaneously to change the CO concentration setting to the desired level h Press up arrow twice to return display to the default setting showing current temperature Incubator Alarm Conditions The following incubator alarm conditions will activate an audible alarm in the device The alarm conditions are recorded in the data files of all slides currently measured and the alarm will appear on the warning tab in the running window ei To inactivate an audible alarm Press the Reset Alarm touch pad CG The red LED will remain lit until the error has been eliminated even after the audible alarm is turned off The following error conditions will activate an audible alarm e Temperature deviates from set value by more than 0 5 C If CO regulation is on e CQO concentration deviates by more than 0 5 from set value e CQO inlet pressure is too low lt 0 5 atm If O2 regulation is on e OU concentration deviates by more than 0 5 from set value e N gt inlet pressure is too low lt 0 5 atm Computer Alarm Conditions The following malfunctions of the built in PC and failure to close the load door correctly will activate another audible alarm A computer failure may result in a loss of time laps
35. re when loaded in to the EmbryoSlides 2 Remove bubbles When initially filling the EmbryoSlide with medium a bubble will remain in each micro well See illustrations below These bubbles must be removed carefully with a Stripper tip MidAtlantic Diagnostics Inc or a sterile 20 ul Eppendorf gelloader tip Use a microscope to confirm that micro wells have been filled with medium and do not contain any bubbles Well with bubble Well with bubble Well without bubble 3 Remove flushing medium from the large reservoir and from the wells except for the tiny amount of medium that remains in the central micro well of each well Discard the flushing medium after removal 4 Fill each well with 25 ul of cultivation medium containing HSA at room temperature e g EmbryoAssist from Medicult Origio The EmbryoSlides should be refilled with media and covered by oil as soon as possible to avoid evaporation 5 Load 1 2 ml of LiteOill into the reservoir Make sure the all wells are covered with a common confluent oil layer to eliminate evaporation EmbryoSlides with lids on are transferred to an incubator to equilibrate at the desired cultivation conditions e g 37 C and 5 CO2 22 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 The EmbryoSlides with lids must equilibrate for a minimum of 20 hours before use Loading embryos into EmbryoSlide wells General
36. rstream The EmbryoSlides MUST be covered with sterile lids before insertion into the EmbryoScope D The device must always be connected to an un interrupted power supply UPS to ensure stable operating conditions in case of power failure 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 result of operating the EmbryoScope D Should an accident occur while using the EmbryoScope stop using the device until it has been checked by an authorized service agent The device may only be operated by trained personnel The device includes moving parts with safety stops Do not try to block safety sensors to insert a finger or a hand into the device while it is turned on This is dangerous and may cause injury Do not touch any moving parts when power is ON or during operation This may cause injury Mishandling or misuse of the EmbryoScope may result in serious injury to the user Installation and Maintenance Installation inspection adjustment and wiring of the EmbryoScope D can only be carried out by a certified Unisense FertiliTech A S employee The EmbryoScope 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 Unisense FertiliTech A S EmbryoScope Embryo Monitoring Sys
37. s a built in internal industry grade PC running Microsoft Windows Vista The PC controls all data acquisition motors camera etc However the incubation conditions temperature CO and O levels are controlled by an independent control unit Optimal incubation conditions are thus unaffected by software failure or failure in the operating system of the PC Regardless an audible alarm will notify the user in case of software failure or failure of the PC operating system see Computer alarm conditions below Turn on the Device 1 Turn on the EmbryoScope D on the main switch green switch rear side upper right corner 2 The incubator control panel left side on front controls the incubation environment It contains the following touch pads 4 Ee Alarm Heating Display SetPoint Down Up 3 If the back pressure of the CO and N gas lines connected to the device is not correct 0 6 to 1 0 bars an audible pressure alarm will activate and the red diode m the alarm touch pad will turn on 4 If the device is to run at ambient OU concentration 1 e without any nitrogen supply the O2 regulation should be switched off a Press the Reset Alarm touch pad GS b Press up and down arrows simultaneously aD to enter settings mode The display shows LA Gta c Press down arrow six times until display shows ocr Oxygen regulation 10 Unisense FertiliTech A S EmbryoScope Embryo Mon
38. tem Version D User Manual 2010 version 2 10 Contents KI et ER LE 1 MNGICATIONS TOR Eege 2 erer 2 IMPORTANT Safety Instructions sceeccccscecccccsccccccssccccccssceccocosceccocssccccosssccccosssseccesccsescessssceee 3 General OVET view een 5 EUR 5 EE EEN assai E R NA ESN 5 Techical SpecCiiCaulOns EE 6 DG VICE SCD ocrni ne aE a EEA ee Ea E Ee EEES 7 Instructions and Training of Personnel cccccccccssssssseececeeeceaeeseseeececeeeeaaeeseeeceeeeesssaaenseseeeess 7 1B Les Avorn e EE 7 Unpacking and Setip of Fret ee gg Ee ee E Bae 8 Comecon ENTREE 9 IG VICE Sar Peann E ee E ES 10 Change Temperatire Setting Of INCUD ALOR recesie i ERARA 11 Chanse Gas Mixture Seting Of Incubator ee 11 Incubator Alarmi Condit ons EE 12 Computer Alarm Condit lOi S seresa e E a aa 12 Change and Inspect Incubation Values and Parameters ccccccccccccceceesseeeeeceeeeeeeaaeesseseeeees 13 Lock ere Noy 1100 oa EE 15 Measurement SCUD oesscccucstissdevescdcaceessccsevessecauchiasedescdzccsceussascssesacsuebdaadesuisececenssecacsveanceecetasadess 15 Preparation of EmDryOSlid eege 21 Filling El ee e Eege E E 22 Loadinge embryos into Embryoslide wells enee eege eesti deena 23 Start Tee reene 24 Add SAN Sates catle i oasis cessing sos educa tcc sds nal cabs eae se asisred cede p ds calvin aip cme saa lmcn deena tects 25 Finding Wells and Focal Planes for Image Acquisition cceeeeccccceccceeeeeeeeeeceeceeeeaaeesseeeeeees 21 IS
39. terminated correctly after the previous run the motors may have lost their calibration A Reset must also be performed when the slide holder has been re mounted after cleaning or inspection a l Choose the Standard adjustment method and follow the software instructions a 2 When the well picture of slide 1 well 1 is displayed press in the middle of the well 16 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D Calibration of camera position 1 X Y calibration Slide 1 Well 7 2 Focus calibration Slide 1 Well 1 3 Focus Calibration Slide I Well 4 4 X Y Calibration Slide 6 Well i 5 Focus Calibration Slide e Well I User Manual 2010 version 2 10 a 3 Adjust the well until it is in the middle of the picture adjust the focal plane until the bottom of the well is visible press In Focus Calibration of camera position 1 X Y calibration of lide 1 Well 1 iy 2 Focus calibration Slide 1 Well 1 3 Focus Calibration 4 X Y Calibration Slide amp Well 1 5 Focus Calibration r lide 6 Well i iy Focus and center the well bottom Press In Focus to proceed Increment um FEH Recvevcvenseeneuanavensed Focus 623 0002 A 0001 00S 0 17 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 a 4 The picture of slide 1 well 4 is displayed Adjust the wel
40. ther parameters contain the current values of conditions in the device e g current CO flow rate On the next page is a short listing of all parameters indicating whether they are adjustable or reflect the current status Current Some of the current values may be adjusted e g the current reading of the internal oxygen sensor as part of a calibration procedure where the current reading is replaced by a reading from a certified calibration device Press the up and down arrows to adjust values These parameters are marked Current adjustable in the list Some parameters are internal control variables that can be used to turn the incubator on or off at given time points These timers should NOT be used when operating the device Other parameters are internal control variables that govern the way the temperature and gas control operate e g PID base value These parameters should NEVER be changed under normal operation setup 13 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D um CoSP Led User Manual 2010 version 2 10 temperature measurement unit C or F adjustable Co SP desired CO concentration SetPoint adjustable Co2 C current CO concentration current adjustable Co2 r regulation of CO concentration on off adjustable 02 SP desired O concentration SetPoint adjustable 02 C current O2 concentration current adjustable
41. there are no active slides the environmental data are not saved to the disk CO and O gt tabs The figure below shows the content of the CO tab which is similar to the Oz tab This tab shows the measured CO concentration blue line in the embryo chamber during the experiment The graphs also show flow rates green line and back pressure purple line on the CO gas inlet em b LA on 9 1 La CH 0 0 I h 0 6 bar Concentration and Flow n N N d CH erh N Set Point 5 0 e 06 11 07 11 07 11 08 11 03 11 09 11 Date wem Time Warning 09 11 CO 12 11 10 11 10 11 11 11 11 11 Reset Alarm Home Cv Ath Image Processing CO 5 1 9 5 Slide 2 Well 4 No O Eventual CO warnings are shown in the table below the graphs The small black crosses indicate time points where the load door has been opened e g when inserting or removing slides Temperature tab When touching the temperature button the recorded temperatures of the EmbryoSlide holder are displayed The measurement readings have been calibrated to reflect the actual temperature of an embryo in an EmbryoSlide well placed firmly in the EmbryoSlide holder Viewer Settings 35 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D Temperature User Manual 2010 version 2 10 38 0 38 0 37 9 37 9 Temp
42. this ensures data integrity and reduces the risk of erroneously ascribing measurements to the wrong embryo 10 Touch Done 26 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 11 All measurement data from a slide including images temperature and gas measurements device performance log file entries and warnings are saved in a file named DYEAR MM DD_SMMMM _INNN pdb e g D2009 03 19_S0045_I004 pdb where YEAR MM DD 1s the year month and date when the measurements were started e g 2009 03 19 March 19 2009 The file is saved in a folder on the desktop called Scope data MMMM is the number of the slide measured in the device assigned automatically as a unique consecutive number for this particular device e g number 0045 NNN is the device number e g number 004 Computer Local Disk C Users Embryo Documents Scope Data Bi Organize T Faune Lini Mame Date modified Type Size E Documents 1 D2009 11 12_50044_1019 pdb 12 11 2009 14 23 PDB File 27 289 KB sf _ D2009 11 12 50043 1019 pdb jou 12 11 2009 14 26 PDB JOURNAL File 0 KB E Pictures D2009 11 12 0043 1019 pdb 12 11 200914 23 PDB File 27 598 KB WW Music 2009 11 10 50042 1019 pdb 12 11 200909 21 PDB File 289 335 KB More 1 D2009 11 10 S0041_1019 pdb 12 11 200909 28 PDB File 328 128 KB 12 If there are free slide positions the system will ask you whether you want to
43. tilization 11 nov 2009 12 00 Run 6 Time Since Fertilization Od 23h 27m Slide 6 Description Fertilization 11 nov 2009 12 00 Run 7 Time Since Fertilization Od 23h 29m ek SCH Image Processing J 2 2 pS i j 37 0 ODS 1 No O2 Viewer Settings Slide 2 Well 6 The program will automatically start with the first measuring cycle and begin to retrieve images of each well in different focal planes 29 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Runtime Feedback Below are some of the data that can be obtained from the display while the device is running The basic panels for each of the slides slides I to 6 the running conditions temperature gas viewer and settings and warnings and errors that have occurred warnings are accessed by touching the respective tabs An active tab is white the others are blue gray Slide Tabs To obtain more information and see the last images from a slide touch the slide tab at the top of the screen Patient Description v Fertilization 11 nov 2009 12 00 Run 6 Image Processing z i 37 0 COJA No O Viewer Settings Slide 2 Well 6 i 2 The slide tabs contain general information intended for the operator of the device so s he can follow the embryo development All data are saved continuously to the computer hard disk so the data can be recov
44. ual 5I Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 In Case of Emergency ALWAYS Call Unisense FertiliTech A S service telephone 45 70230500 The Service phone is always open to receive calls 24 7 Our address and fax number can be found on our website at Http www fertilitech com Disposal of Waste Identification of risks associated with the disposal of the EmbryoScope D 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 This include PCBs lead free HASL switches PC batteries printed circuit boards and external electrical cables All components are in accordance with the RoHS Directive which states that new electrical and electronic components do not contain lead mercury cadmium hexavalent chromium polybrominated biphenyls PBB or polybrominated diphenyl ethers 52 Unisense FertiliTech A S EmbryoScope Embryo Monitoring System Version D User Manual 2010 version 2 10 Unisense FertiliTech A S Tueager 1 8200 Aarhus N Denmark UNISENSE UNISENSE FERTILITECH DENMARK www unisense com info fertilitech com 53
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