Microsoft word - scheda tecnica d-sight-f 2.0 rev 1 en.doc

TECHNICAL DOCUMENTATION
D-Sight-F 2.0 SYSTEM
Hardware Devices

Processing Unit
CPU with Intel® Xeon®, 4GB RAM ECC; 4 Hard Disk 500Gb RAID 10 (1TB
overall storage capacity), DVD; Controller on-board of the motorized stage for
high scanning speed and perfect synchronization with the digital capture unit.
Display Unit
LCD Monitor 24 "1920x1200 pixel high-resolution wide-screen format, with
dynamic management of contrast and brightness of 450 cd/m2, a clear display
and provides detailed and high fidelity color reproduction, contrast and a
uniform perfect; brightness settings, gamma, contrast, color saturation and
color temperature.
Scanning Unit
Closed system for scanning, digitalization and analysis of slides in bright field.
Loading device with 5-tray slides. Microscope stands with integrated base
designed to enhance stability and eliminate any vibration. Fast acquisition in
low (4x) and high magnification (up to 60x on immersion). Integrated barcode
reading. Objectives supplied: 4x, 10x, 20x, 40x, 60x; possibility to introduce
two more objective.
Bright field
High quality scanning sensor for a high fidelity color and black and white image
re production Ability to set the objective for high magnification to 10x, 20x or
40x with fully automated operation.
Fluorescence
Possibility to use two scanning sensor . Monochromatic scanning sensor highly
sensitivity and low noise in image digitalization. High quality scanning sensor
for a complete accurate color image re production. Epifluorescence light
system with motorized filters for a totally automated analysis. Possibility to
load up to 6 filters easily exchangeable.
Megaslides acquisition (optional)
With D-Sight-F system is possible to acquire Megaslides.
To acquire Megaslide is enough to use the optional plate of the stage for
macro-slides and a predefined profile for Macro.
Software Functions

D-Sight-F is a system designed to produce a digital slide, both in bright field
and fluorescence. With D-Sight-F it is possible to view and to edit digital slides
with a user-friendly viewing software.
I. D-Sight Archive

Ia) User and Group Management
System allows to manage users and group of users. User access to each
environment is through a login panel, linked to specific permissions.
IIa) Archive structure
Archive is structured on two levels:
− Images: for each slide a number of unlimited images can be acquired. IIIa) Archive queries and consulting Archive access is performed on queries related to slide data (patient data, acquisition date, tissue…). Based on the configuration parameters, an SQL-type search is performed in the data registered in the database for consultation. The selected slides are displayed in a list. Each element of the list includes the preview image of the slide and a series of associated data (patient data, acquisition date, tissue .) that can be sorted for each specific field. IVa) Output and reporting The D-Sight-F software allows report generation with: headings (logo and laboratory data), patient data, results, diagnosis and images. It is possible to print report of all slides of the same patient summarizing results of each test. Va) Data and slides export User can export data of a slide in several modes: − whole case (complete patient data, scanning and analysis) − single acquisition. Scanning are saved into jp2 format following the jp2000 standard compression. They can be used in external application that support this compression standard − photos of a scanning image. Photos can be saved in the following D-Sight Virtual Microscope

D-Sight-F Virtual Microscope allows navigation of the slide, and is enjoyable in
various configurations: inside D-Sight-F system for navigation and scanning of
cases; from the free application D-Sight Viewer, downloadable on-line from the
web browser (Internet Explorer) to display the scans uploaded to the server.
The virtual microscope in this configuration provides the ability to navigate the
slide from any location with Internet connection.
Viewing window
− D-Sight-F allows the study and exploration of the slide using a digital virtual microscope with possibility of interactively changing of the magnification (1x to 160x). − It is active a zooming function, either by command in the screen than means function through mouse scrolling. − It is possible to display "full screen" slide with the active window always on the selection of different objectives. A lot of tools to perform studies on slide are available from navigation environment: Measurements: − Linear distance measures. − Free-hand or polygonal perimeter measures. − Free-hand or polygonal area measures. − Drawings measures (example: area and perimeter of circles, rectangles, − Collimator function: given a straight line, system is able to calculate the distance from a series of points set manually with the mouse (selected by user). − Customizable measures of color, thickness, font and size. − Reversible measures on original image (it is possible to cancel and draw − Measures overlapped on the original image to dedicated photo shoots. Note 1. Each of the measurements are saved and stored by the system on a dedicated electronic table, containing the following information: description of the measure, the measurement value, eventually comments on it. This D-Sight function is deputed to relocate on the original image in the interest points with all measures taken in order to facilitate the most of data management. Drawings: − Insert lines, arrows, figures, text, shapes, etc… − Free customization of color, dimension, character, etc. Design is also the function Note 1, except of course for the value Bookmarks: − The D-Sight-F system allows identification of particular points of interest on the image – selected by user – to refer to future relocations. While browsing the slide user marks special points of that which is considered interesting, without disrupting the overall analysis. As second step it will be possible to recall the bookmarks and the system will relocate the indicated image. Also in bookmarks is valid Note 1. Analysis: Access to analysis forms, available in the system. Edit visible: Made visible / invisible editing on the displayed image (measures and design overlay) Lens: Double magnification of a detail in the image displayed. Picture acquisition: − All images can be saved externally to the system with different file format (jpg, bmp) to be used for several applications (example: powerpoint, report, relations, etc…).
Videos:
Videos of activities performed by user (movements of image, zoom,
measures…)
All the operations (measures, analysis) performed into the digital microscope
are saved separately for each user.
Web
Each slide digitalized by D-Sight F system can be shown from the Web
Interface application. The browser of Internet Explorer can be used to view
images with a series of interactive tools. D-Sight F uses a highly efficient
image compression technique to reduce file size without losing image content.
The resulting phase expected during the file transfer from local to web server
is drastically reduced.
Web instruments:
− “Full screen” slide viewing like on local.
− saving the active screen as an image file.
− navigation of digital slides in “streaming” mode.
− navigation of synchronized digital slides into the same web browser.
− synchronized meeting of multiple users to view one or more digital slides.
− on-line training module.
III. Digital Microscope

The digital microscope is a tool that simulates the use of a microscope, via
software, providing a view similar to that seen with the eye. In particular, you
can:
- Set the hardware profile, as a way of: camera (color, monochrome), light
(bright field, fluorescence) and filter (only for fluorescence). - Run the preview to get a full picture of the slide. Within the same session may be done for all five positions of the plate. - Use the preview of the slide as a navigation tool with the ability to move the motorized table in any position of the slide using the mouse. - Set up to 7 different objectives. - Adjust the camera is in automatic and manual mode (exposure, gain .) - Change hardware profile within the same session. - Acquire images at any time for any purpose and in any profile. The scanned images are saved in a folder that can be set by the user.
IV. D-Sight-F scanning system

The scanning environment allows the authorized user to acquire one or more
slides and turn them into a digital image thanks to a simple and intuitive
wizard.
The first step is to load the data. The data associated to a glass slide are
related to:
• Scanning: select the light source to acquire bright field or fluorescence slide,
specimen and test type
•Patient: personal data
The user can change the data in the following ways:
• Manual: user suggests all settings (scanning and patient).
• Worklist: user selects the worklist (eg an XML file) that the system imports to
end its configuration.
• Barcode: system reads the barcode (1D and 2D) and adds automatically all
the settings.
The second phase is the pre-scan at low magnification the whole slide to scan
(preview).
The third step is the digitization of the slide and includes a series of steps:
• Manual selection of scanning areas
• Scanning of selected areas
The scanning speed depends if acquisition is performed in bright field or
fluorescence.
For bright field slides the focal plane during scanning is controlled using two
possible solutions, that user can select: Speed and precision. If user select
“Speed”, software automatically select some focus points and makes a
prediction of the focus value for each field; if you choose “Precision”, system
refines and optimize the focus evaluated for each field following a z-stack
procedure
In case of fluorescence slide various factors impact on acquisition time:
• the number of probes
• Number of planes for each probe
• Exposure time of the camera
After the scanning procedure the case is stored into the archive.
V. Analysis Modules (optionals)

The software of D-Sight-F system contains modules for image analysis that
provides support to the pathologist for his diagnosis.
For each one of the available tool it is possible:
− The customization of the analysis with the definition of new dedicated
− The selection of regions of interest of analysis at various magnifications and the possibility, within the same fields, include / exclude regions. − Processing of multiple regions within the same image automatically accumulating the partial results into one final result. Membrane analysis: The Membrane analysis software module running a quantification of positive/negative (0, 1+, 2+ and 3+) for IHC HER2 (Human Epidermal growth factor Receptor 2). For each processed image, the system provides an opinion based on the intensity and completeness of membrane staining for every tumor cell and the overall percentage obtained on the histological sample. The results are shown graphically highlighting the membranes with a different color depending on the degree of positivity. The system also provides a numerical representation of the results using the percentage of cells belonging to each class. Nuclei analysis: The Nuclei analysis software module is used to quantified the intensity of positive/negative (0, 1+, 2+ and 3+) a ICH ER (Estrogen Receptor), PR (Progesterone Receptor) e Ki-67. For each processed image, the system provides an assessment based on morphological and staining of the nuclei. The results are shown graphically highlighting the nuclei in a different color depending on the degree of positivity. The system also provides a numerical representation of the results using the percentage of households belonging to each class. TMA: The TMA Analysis software module allows digital analysis for Tissue Micro Array (TMA), in three steps: slide scanning, association between each spot with patient’s data and spot virtual browsing. In detail, during spot-patient association, the system automatically identify all the spots and loads, from external file (.xls), all the patient's information and it directly associated with the found spot. Using virtual spots's browsing is possible both: view spots inserted in the slide and all the data extract from the external Excel file, and make searches. For example is possible to search all the spots of the same patient insert in more than one slides. FISH-HER2: Fluorescence analysis (FISH) is a technique used to individuate the presence of specific chromosomes DNA sequences. The evaluation of Her-2 genes amplifications consists in evaluation the relationship between the Her-2 canal and CEP-17 probes for a representative set of tumor nuclei. HEr-2 module allows to do the following operations: 1. Slide fluorescence scanning and direct association with the brightfield slide After fluorescence low magnification slide acquisition with DAPI filter, the system makes a software association between the brightfield slide (with a positive membrane analysis identification) and the fluorescence one, in way to have the possibility to synchronize the slides acquisitions, and to overlap and view all the brightfield processing membrane areas on the fluorescence slide’s image. The analysis of the level’s amplification of Her-2 probes is done in fluorescence way using a 60x oil objective. The system can acquire more images for each canals (counter stain and the two probes) in different focus planes to effect an automatically merge and create an image without the auto-fluorescence effects of the probes. Automatically identification of neoplastic nuclei, with single probes spots extraction, allows to indentify the amplifications level for each nucleus and obtains mean amplifications values in a predefine nuclei’s numbers. Nuclei’s elaboration can be personalized using different analysis’s profiles and level of confidence to evaluate the amplifications. In a work session all the partials results of the used images are summed and a gallery allows to view again all the selected nuclei.
VI. FLUORESCENCE

Having a properly equipped elaboration unit, it is possible to put a fluorescence
scanning beside a bright field scanning. Scanning speed is directly related to
the previously set time exposure and by the way it is superior to what
indicated for the bright field. Properties and functions described for Preview
and High magnifying scanning are valid in that operative mode too, as it is
described on paragraphs dedicated to “Virtual Microscope D-Sight-F”, to the
“D-Sight-F archive” and to the “Digital microscope”.
D-Sight-F Specifications
Technical specifications:
Objective
Two available accommodation to introduce standard microscope objectives. It is related to: • number of probes • number of planes of each probe • exposure time of the camera For example, if are used a counter stain and two probes with 13 planes, the acquisition time of a single field is about 25 seconds. 1x1cm a 20x ≈ 80MB (not compressed ≈ 1GB) 1x1cm a 40x ≈ 140MB (not compressed ≈ 4GB). 1x1mm at 60x ≈ 50MB (not compressed ≈ 300MB) (fluorescence)

Enviromental Condition:
Working:
Temperature 0-40°

Transport / Stocking:
Temperature

Electrical specifications:
Input Voltage

Mechanical specifications:
Height:60 cm Width:60 cm Length:40 cm Weight:40 Kg Inches:24” Resolution:1920x1200 Height: 46 – 55 cm Width:25 cm Length:57 cm Weight:10 Kg Symbol for separate collection applicable in European countries
This symbol indicates that this product is to be collected separately.
The following apply only to users in European countries. • This product is designated for separate collection at an appropriate collection point. Do not dispose of as household waste. • For more information, contact the retailer or the local authorities in D-Sight F 2.0 follows the instructions of Directive 98/79 EC on In Vitro

Source: http://www.en.menarinidiagnostics.it/content/download/8913/47519/file/Scheda%20tecnica%20D-Sight-F%202.0%20rev%201%20EN.pdf