Summary of Contents for Vitrolife Octax LaserShot M
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Octax LaserShot M ® Octax NaviLase User Manual Recommended use of Laser Systems January 2021, Version 7 User Manual Laser Systems version 7...
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NaviLase. Sections referring to dynamic laser system NaviLase are explicitly intended for users of this system. You may copy this for internal use only, not for publishing. The Vitrolife logotype is a trademark of Vitrolife Sweden AB, registered in Europe, the U.S. and other countries. Vitrolife Sweden AB Box 9080 SE-400 92 Göteborg...
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Biopsy of polar bodies from human oocytes or of selected cells from embryos by use of the Octax LaserShot M or NaviLase system for the purpose of subsequent genetic analysis can be helpful in patients in case of suspected or proven genetic disorder and/in case of suspected aneuploidy of their oocyte(s).
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Intended user group Healthcare professionals, typically medical technical assistants (MTA) or clinical embryologists. The user has to have at least basic experience in working in an IVF laboratory, especially with one or all of the procedures in which the use of a laser system is potentially indicated, e.g. ICSI, Assisted Hatching, Biopsy, Vitrification. Intended patient target groups Female and Male patients in the age group below a maternal age of 60 that have failed to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse and / or patients with a specific...
Contents Definitions Structure of EyeWare Video Page with Laser Targeting Warnings Feature Calibration of the Hole Size Predictor Precautions The Full Screen Mode: LaserShot M and dynamic operation of NaviLase Electromagnetic Compatibility (EMC) Quick File Page for Rapid and Electromagnetic Immunity Temporary Storage of Images The Quick File Toolbar Symbol Glossary...
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Contents Part III: Additional Information Advanced Image Handling Functions Open Image and Save Image Dialog Program Settings Camera Settings Generating Support Request Data Maintenance Cleaning and Disinfection Troubleshooting Guide Decommissioning of LaserShot M / NaviLase Customer Service Part IV: Quick Guide Laser Aiming Verification Procedure Hole Size Predictor Adjustment NaviLase Reset...
ABOUT THIS MANUAL The procedures described in this manual concern a particular device installed by Vitrolife GmbH authorized personnel at a designated location. The LaserShot M or NaviLase devices must be operated by trained personnel according to the instructions contained in this user manual.
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INTEGRITY OF THE ELECTRO-OPTICAL SYSTEM Maintenance of microscope components, wrong handling of the microscope or strong displacement of the electro-optical system, e. g. by mechanical shock can result in an incorrect position of the beam splitter system, the magnifier lens, the camera, and the turret, respectlively.
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INSTALLATION AND MAINTENANCE Installation and repair of the LaserShot M or NaviLase shall only be carried out by a person certified by Vitrolife. The LaserShot M must remain on the microscope and at the location where it was installed. If a LaserShot M or NaviLase is disconnected and/or moved without...
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Vitrolife, and connection must only be made using certified cables. LIMITED WARRANTY Vitrolife warrants the LaserShot M or NaviLase to be free from defects in materials and workmanship for a period of two (2) year from the day of shipping.
The user of the laser system should report any serious incident that has occurred in relation to the device to Vitrolife and the competent authority of the Member State in which the user is established.
Electromagnetic Compatibility (EMC) The below table contains the applicable information required for CISPR11 systems: Guidance and manufacturer’s declaration – Electromagnetic emissions LaserShot M and NaviLase laser systems is intended for use in the electromagnetic environment specified below. The customer or the user of LaserShot M and NaviLase laser systems should assure that it is used in such an environment Emissions test Compliance...
Electromagnetic Immunity Guidance and manufacturer’s declaration – Electromagnetic immunity LaserShot M and NaviLase laser systems is intended for use in the electromagnetic environment specified below. The customer or the user of LaserShot M and NaviLase laser systems should assure that the used in such an environment Immunity test Compliance Electromagnetic...
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The below two tables contain the applicable information required for a system other than those specified for use only in a shielded location and for systems that are not life supporting. Guidance and manufacturer’s declaration – Electromagnetic immunity LaserShot M and NaviLase laser systems is intended for use in the electromagnetic environment specified below. The costumer or the user of LaserShot M and NaviLase laser systems should assure that it is used in such an environment Immunity test Electromagnetic...
Part I: Introduction This chapter provides an outline of the key features and applications of the LaserShot M/NaviLase system Introduction The laser systems for microsurgery utilized in the field of assisted reproductive technology (ART). The laser systems can be used to manipulate the zona pellucida of oocytes or embryos in order to assist hatching and to extract polar bodies or cells for subsequent genetic analysis.
an external database allows importing and exporting of datasets. A predefined report with any set of examination results can be printed after only a few mouse clicks. Datasets may be exported to PDF-files for e-mail forwarding and to RTF-files or to CSV-files for further text or spreadsheet program processing, respectively.
Manipulation of the Zona Pellucida using LaserShot M / NaviLase The laser beam generated by the LaserShot M / NaviLase causes a tangential thinning or opening of the zona pellucida of oocytes and embryos by a highly localized photo thermal process which lyses the glycoprotein matrix.
Application notes for LaserShot M and NaviLase Assisted hatching (AH) The aim of AH is to locally weaken the zona pellucida by creating a trench along the optical axis of the laser beam (see. Fig. 1, p.17) which appears as a hole when seen through an inverted microscope.
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Blastomere biopsy (cleavage stage) The aim of cleavage stage biopsy is to retrieve 1 or 2 blastomeres from a day three embryo for genetic analysis. A pulse time should be selected to create an opening of about 20 μm. The embryo should be rotated and blastomere(s) selected for biopsy should be positioned using a holding capillary.
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If cells are to be biopsied from cryopreserved blastocysts, laser application should be performed after thawing, as soon as the ICM can be located and before the blastocyst has fully re-expanded. A hole of 15-20 μm should be created opposite from the ICM. Thawed blastocysts will have TE cells herniating out of the zona pellucida after 2 to 3 hours of re-expansion.
The recipient end user of the device should not install the device upon receipt. Unpacking, installation, setup and end-user training of LaserShot M / NaviLase systems must be carried out by appropriately qualified technical staff authorized by Vitrolife GmbH. EYE SAFETY OF THE OPERATOR...
System Components Figure 2 shows the LaserShot M / NaviLase system mounted to an inverted "Olympus" microscope, consisting of: • the NaviLase Motion Module (NaviLase only) • the Laser Module • the Mirror block • the Laser Lens • the Eye USB 2.0 camera Fig.
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Inverted microscopes have to have a CE declaration according to IVD 98/79/EC as a minimum requirement. The following inverted microscopes are approved to be used with laser systems (this list raises no claim for completeness): Manufacturer Model Type Olympus Corporation IX 51 S8F-3 IX 53...
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(i.e. EN 60601-1 - Part 1 for medical electrical equipment) and essential performance, this equipment must only be connected to computer equipment certified by Vitrolife, and connection must only be made using certified cables. One EyeWare license running on a dedicated PC is intended to control one laser system.
However, do not disassemble or uninstall the LaserShot M / NaviLase system. Any installation / deinstallation of hard - and software, respectively, is strictly reserved to trained and certified service personnel authorized by Vitrolife GmbH. User Manual Laser Systems version 7...
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On the laser module two status indicator LEDs and an USB connector are located, as shown in Figure 4. The status indicator LEDs provide information about the status of the device in addition to any messages/warnings displayed by EyeWare when controlling the LaserShot M / NaviLase system.
Part II: Working with LaserShot M / NaviLase This chapter provides basic information about operation and control of the LaserShot M and NaviLase device in conjunction with the EyeWare software. Control of the Laser by EyeWare Software The EyeWare software provides the user interface for targeting, controlling and activating laser pulses in LaserShot M and NaviLase system in combination with an Eye USB2 high-resolution camera.
Installation Requirements For proper operation of the EyeWare software, a computer system complying with the following minimum specifications is required: • INTEL i5 or i7 CPU • Intel Chipset (this is a must) • 4 GB RAM minimum • 500 GB hard disk minimum •...
Unpacking, installation, setup and end-user training of LaserShot M / NaviLase systems must be carried out by appropriately qualified technical staff authorised by Vitrolife GmbH. Calibration setup Calibration of objectives and the intermediate magnification is done during the setup of the laser system.
Specify manufacturer of the lens and its magnification for each individual nose head position. For any nose head position not hosting any lens uncheck the box "in use". After definition of all 6 positions is done, confirm the settings and restart EyeWare in order to apply the new settings.
Structure of EyeWare The EyeWare software consists of several program sections each appearing as separate pages at the EyeWare main window. See Figure 11 for the different elements of the main window (menu bar, main toolbar, pages and status bar). Menu bar Main Toolbar Pages...
Main Toolbar The main toolbar contains the most important commands, such as image file management, video snapshot and the standard clipboard buttons. Pages The software is organized into six pages, representing areas of the program. By changing between pages, certain actions are triggered. 1.
Appearance of the Crosshair The video image can be overlaid by a Crosshair which indicates the target area of the laser beam. A combination of up to two crosshairs and three circles can be selected. The circles represent diameters of 10 μm to 40 μm of the microscopic image shown on the monitor. In order to activate or change the appearance of the Crosshair, select Video –...
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The cell should be positioned at the bottom of the dish. 3. Locate the cell through the laser lens and focus on the zona pellucida. 4. Unlock the laser, using the corresponding software button. 5. Select “Hole” as working mode from the menu if using NaviLase. 6.
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INFLUENCE OF Z-POSITION OF THE OOCYTE/EMBRYO ON DRILL OPENING SIZE Inappropriate Z-positioning will result in smaller drill holes and in reduced laser beam quality. It is recommended to keep the cell near the bottom of the culture dish during laser treatment. Alignment of the Crosshair In order to match the position of the Crosshair with the center of drilled hole,...
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The Video Toolbar The Video toolbar provides the elements of the user interface for controlling the laser Pressing the Key button turns the laser into active mode. Clicking the Laser release button triggers a laser pulse. Alternatively the laser can be triggered by pressing the laser release button of the computer mouse or optionally by an external foot switch.
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Triggering the Laser After switching the laser into active mode and selecting the irradiation time, LaserShot M / NaviLase can be triggered by clicking , by pressing the laser release button of the computer mouse or optionally with an external foot switch. Taking Snapshots A snapshot of the live video image can be taken by clicking the camera button at the main toolbar, in the Video menu or by pressing the <F9>...
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Calibration side bar For quick recalling a pre-defined calibration set due to changing the objective or intermediate magnification, select the corresponding button within the left sidebar of the EyeWare window (Fig. 17). Calibration settings for objectives Calibration settings for intermediate magnification Camera Mode Fig.
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The recipient end user of the LaserShot M /NaviLase systems should not unpack and install it upon receipt. Unpacking, installation, setup and end-user training of LaserShot M systems must be carried out by appropriately qualified technical staff authorised by Vitrolife GmbH. User Manual Laser Systems version 7...
Image gallery sidebar Any image being taken by using the quick snapshot function by pressing the <F10> key will be displayed in the right sidebar on the Video image page (Fig. 19). The image gallery sidebar provides instant display and easy navigation between acquired images which have been stored to Quick File.
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Taking Snapshots Snapshot images acquired by either clicking the "Snapshot" button or by pressing the <F10> key are displayed within the image gallery. Individual Snapshot images within the gallery can be enlarged by moving the mouse cursor across the image of interest (Fig. 21). Fig.
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Hole (NaviLase dynamic operation) After selecting "Hole" as the designated operation mode, the electronic laser target gets activated. It indicates the current position of the laser impact and the expected hole size, depending of the selected pulse time. By using the drag & drop function of the mouse the electronic target can be moved to the intended position within the working field (Fig.
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Hatching (NaviLase dynamic operation) The "Hatching" mode offers the possibility to apply a defined number of laser pulses along a straight line. It is ideal for drilling small openings, either for assisted hatching or for biopsies After selecting "Hatching" as the designated operation mode, the electronic laser target gets activated.
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Fig. 25: NaviLase operational mode for drilling holes along a predefined curved line The degree of overlapping between adjacent circles and hence the shape of the line produced by the laser can be determined by adjusting the number of pulses whilst keeping the pulse time (the hole size) at a defined value (Fig.
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TE mode (NaviLase dynamic operation) The "TE" (trophectoderm) mode offers the possibility to apply a preselected number of one to three laser pulses along a straight, vertical line. It is used to support a trained operator during trophectoderm biopsy for the step of releasing intracellular bonds between mechanically streched trophectoderm cells.
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For operation in full screen mode, the electronic target line can be moved to the intended position within the working field by dragging & dropping the red starting spot of the line (Fig. 28). Adjustment of the laser impact can be done by modifying the "Pulse time" either by moving the respective slider, clicking to the arrows or turning the mouse wheel.
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After selecting "Trophectoderm mode" as the designated operation mode, the display of laser pulse length changes from green to red color. This is to indicate that TE mode is active and the last pulse length used in TE mode has been saved and is displayed. The Hole Size Predictor (circle) is inactivated automatically.
Quick File Page for Rapid and Temporary Storage of Images The Quick File provides a clipboard-like storage of images without associated measurements. It can be useful for quickly saving an image without following the complete procedure of the Storage Wizard. For recalling an image from Quick File and displaying it at the Image page, e.g.
The Quick File Toolbar The Quick File toolbar mainly includes the functions similar to the functions of the Database toolbar. For information regarding a specific button move the mouse cursor over any button to get a short description of its function or consult the chapter Database Page. Additional functions are: Delete Function For deleting selected items of the Quick File click on the trash can icon.
Measurement Toolbar For information regarding a specific button move the mouse cursor over any button to get a short description of its function. Measurement Function By using the measurement function new measurements can be applied. In order to determine the size of an object, click to the position where the line should start and hold the mouse button down until the end point is reached.
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Type of Measure Line The type of measure line can be modified in the Measure menu. Either a predefined label (cell diameter, cell total diameter, hole diameter, zona pellucida thickness) can be selected (Fig. 32) or a new type of measure can be created using the measure customization dialog.
Measure Line For the individual appearance of the measure lines their color, arrow color, arrow fill color, shadows and text font can be configured (Fig. 34). Fig. 34: Measure customisation dialog, measure line properties Storage Wizard for Associating Images with Patients For simplifying the process of storing a new image to the database of EyeWare, the Storage Wizard guides through the steps necessary to save an image.
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2. Adding a new patient When adding a new patient file, the database allows entering a limited amount of information about the patient. • Last Name • First Name • Birthday • Code For the field ‘Code’ either the ID number of the main patient tracking database or any other unique identifier can be chosen.
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4. Adding a new examination An examination is mainly determined by the date at which it is carried out. In addition, the name of the examiner and the examining lab can be added in order to keep track of all relevant examination data.
The Database Page for Managing Data Sets The Database page allows recalling and managing data sets, based on patient data and examination records. Navigation through patient data sets and examination data sets can be accomplished by using the respective navigation bar for each of the sections. (Fig. 39). The database of EyeWare is structured for routine medical use.
The DatabaseToolbar For information regarding a specific button move the mouse cursor over any button to get a short description of its function: Data Navigation Clicking the arrows allows scrolling through the highlighted category or directly getting to the first or last object. Insert / Delete Function The active object may be inserted or deleted.
Report Page for Printing Examination Results EyeWare allows to quickly printing out any set of examination results. The available report layouts are predefined. On the Report page, a preview of the examination report selected in the Database page is displayed below. This report will be printed as shown in the preview when the print command is issued after confirming the Print Dialog.
The Report Page Toolbar For information regarding a specific button move the mouse cursor over any button to get a short description of its function. Navigation Function In case of a multipage report, navigation is possible by use of the arrow buttons. Zoom Function Zooms the preview to display the whole page, to 100% or to maximal width respectively.
Getting Started Prior to the first use of the LaserShot M or NaviLase system or • each time the whole microscope setup has been moved • if the LaserShot M / NaviLase system was not used for a period of time •...
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In order to match the position of the crosshair with the center of drilled hole, select Video - Overlay – Customize from the menu and correct the position of the crosshair in XY-orientation by scrolling the sliders. After checking / aligning the crosshair in NaviLase home position, verify target position also in NaviLase dynamic mode as follows: position the spare cell in a corner of the NaviLase working area, move the laser target to the zona and trigger a single laser pulse.
Relationship between irradiation time and opening size According to the drilling strategy, a single laser pulse must generate a hole of appropriate size. The relationship between laser irradiation time and opening size is influenced by various factors such as the type of microscope, the kind of heated microscope stage (glass or metal), the type of heating system, the temperature, the culture dish, the culture medium, and finally the thickness, type and hardness of the zona pellucida.
8. Release the laser by clicking the button or by pressing the footswitch while avoiding any vibrations of the microscope. 9. Verify that the diameter of the newly created hole is identical with the diameter of the circle indicating the position and diameter of the laser holes. In case you observe a difference of the two diameters, re-check if all the following settings applied: temperature of the dish and microscope stage was 37°C / 98.6°...
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Vertical (Z)-Positioning Using a holding pipette to ensure the positioning of the embryo during laser treatment can be an advantage, but also introduces an additional parameter that needs the user’s attention. For optimal results, the vertical (Z)-position of the holding pipette should always be as such, that the cell remains near the bottom of the culture dish during laser drilling.
Variation of the Laser Drilling Position and Strength After strong displacement of the whole electro-optical system, e.g. a mechanical shock, the quality of the drilled hole has to be checked when using the parameters which had been adjusted previously (irradiation time and aiming of the laser). The laser drilled holes and openings will be of good quality if the laser impact is located near the center of the live video image on the monitor.
Part III: Additional Information Advanced Functions of EyeWare, Advanced Database Functions, Program Settings and Camera Settings are listed in this chapter. Furthermore information about Maintenance, Troubleshooting and Customer Service is provided. Advanced Image Handling Functions Open Image and Save Image Dialog EyeWare allows import of images and saving images to file.
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Save Image Click and highlight an image at the Database or Quick File page and select Save Image. Save with Measurements Images to which measurements have been added can be stored together with the measure lines from the Image page. Fig.
Send Image as e-mail Attachment EyeWare automatically launches the e-mail program, composes a new mail and attaches the selected image file (the computer running EyeWare needs to support Microsoft Outlook®). Fig. 46: Sending an image as an e-mail attachment ...
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Mouse This dialog allows configuring the properties of the computer mouse. While mouse pointer is located at the Test Area any click of one of the mouse buttons will reveal which mouse button corresponds to which button number. Tick the checkbox to select the mouse button that triggers the laser pulse.
Camera Settings The NaviLase system comes with an Eye USB2.0 camera. Exemplary, Fig. 50A, B show the camera properties of an Eye USB2.0 camera (1280x1024, 15 Hz). Usually, exposure, gamma and white balance should be set to automatic, whereas brightness and contrast can be adjusted manually.
• Save to file: Select where to save the System Data and wait until data are copied. Attach the file to an e-mail or send a disk with the System Data to Vitrolife GmbH. For contact details please refer to the technical service section.
A preventative maintenance of the laser is recommended every 12-18 months to ensure optimal performance of the laser. System updates will be provided within short response times by technical staff of Vitrolife GmbH, Germany. For contact details please refer to Customer Service.
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1. Cleaning and disinfection of metal and plastic surfaces of LaserShot M and NaviLase components. Moisten a lint-free cleaning tissue with a non-volatile, quaternary ammonium based disinfectant, ready to use for cell culture environment. The tissue should be slightly dampened, not wet. Wipe the surfaces of the laser components and let the disinfectant dry. 2.
Troubleshooting Guide In case some technical problems occur during operation of LaserShot M/ NaviLase please check possible causes of defects according to the list below before contacting the technical support. Problem Possible Cause Recommendation Misalignment • whole setup has been moved Misalignment in "home"...
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unexpectedly small drilling glass stage yes/no laser irradiation time has to be sizes culture media in use adjusted as described in the drilled opening is suddenly section Laser irradiation time smaller as intended determination for appropriately sized openings excessive z-position for optimal results, the vertical (Z)-position of the holding pipette should always be such...
Decommissioning of LaserShot M / NaviLase For decommissioning of the LaserShot M / NaviLase system please send back to Vitrolife. For contact details please refer to the section Customer Service below. Customer Service TECHNICAL SUPPORT If you need assistance at any time, please contact Vitrolife Technical Services.
Part IV: Quick Guide The Quick Guide outlines in a tight and concise manner important and frequent operations. Laser Aiming Verification Procedure Start the EyeWare by double clicking icon on your desktop, read and confirm the message and select Video page. •...
If required: correct the position of the crosshair in XY-orientation. Therefore select Video - Overlay – Customize from the menu (Fig. 53A) and scroll the sliders. Alternatively, click and highlight one slider and move the crosshair with the cursors of the keyboard into position. This allows more precise control (Fig.
NaviLase Reset Every time the EyeWare is started, an automatic initial positioning of the NaviLase motors is performed. A forced repositioning can be performed by using the NaviLase Reset function. It may be used after longer time of pausing the laser while EyeWare was running. Click on Device ->...
Working Principle LaserShot M - NaviLase Insert the laser lense LaserShot M / NaviLase NaviLase Static mode Dynamic mode Open the Video page Open full screen view <F11> Focus to zona pellucida at equator level Focus to zona pellucida at equator level and position oocyte or embryo and position oocyte or embryo Activate laser...
Taking snapshots Taking snapshots Using the <F9> key Using the <F10> key automatically opens does not interrupt the the Image page, live video display. The from where images snapshot is stored to the can be saved to the Quick File from where it can be saved to the database.
Part IV: Appendix The Appendix contains further documentation Target Pointer The Target Pointer is an optional device for LaserShot M and NaviLase which can be used to localize the laser target by the position of a red LED dot when looking through the eyepieces of the inverted microscope.
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b. When releasing a laser pulse, simultaneously the central LED is switched off and the square pattern of four LED dots is turned on for a 2 seconds interval. This optical pattern indicates the instant of laser impact and enables for unhindered view at the targeting area of the laser.
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Adjustment procedure First check if dioptre is set to ZERO for both of the eyepieces (Fig. 56). Indicators are seen on each eye piece lens. Fig. 56: Diopter adjustment (example: Olympus inverted microscopes) Then verify ase shot position matching with the cross hair on screen. If not, adjust laser cross hair position.
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If red light beam is seen very weak or widely spread (Fig. 59) correct the focus of the beam. Use 1.5 mm wrench key (Fig. 61) and turn clockwise and check how the spot changes its appearance. If spot is getting smaller continue turning the focus screw until red dot is set sharp pointed.
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If red dot is still not visible (Fig. 62) check the X and Y alignment. Focus at any specimen located at the bottom of the dish. Watch the spot trough eyepiece and turn the screws for LEFT/RIGHT and UP/DOWN slowly but steady several revolutions until red light gets back into the field of view.
Laser Module Specifications / Labeling Laser Radiation, do not view directly into light path using optical instruments Laser: 1.48 μm Infrared Diode Laser, Class 1M. Definition of a class 1M laser according to DIN EN 60825-1:2014: Class 1M lasers emit in the wavelength range from 302,5 nm to 4000 nm. Power in focus: 100 - 250 mW (depending on microscope, optics, heated stage &...
Related Products SALES For sales information please contact your local Vitrolife distributor or Vitrolife GmbH Dr.-Pauling-Str. 9 84079 Bruckberg/ Germany phone: +49 (0)8765-939900 fax: +49 (0)8765-9399070 email: support.de@vitrolife.com The following Accessories are optional parts of the MDD 93/42/EWG versions of laser...
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Vitrolife Sweden AB Box 9080 SE-400 92 Göteborg Sweden Tel: +46-31-721 80 00 Vitrolife GmbH Dr.-Pauling-Str. 9 D-84079 Bruckberg Germany Tel: +49 8765 939 900 Fax: +49 8765 939 9070 E-mail support.de@vitrolife.com Internet http://www.vitrolife.com User Manual Laser Systems version 7...
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