Hologic Genius, Руководство оператора

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Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 3/13
When any image is being reviewed, the CT or pathologist has the option to electronically mark
objects of interest and include the marks in the slide review. The reviewer always has the option
to move and zoom through a view of the whole slide image, which provides complete freedom to
move any portion of the cell spot into the field of view for examination.
LIMITATIONS
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Only personnel who have been appropriately trained should operate the Genius Digital
Imager or Review Station.
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The Genius Cervical AI algorithm is only indicated for use with the ThinPrep Pap test.
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The laboratory Technical Supervisor should establish individual workload limits for
personnel using the Genius Digital Diagnostics System.
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ThinPrep microscope slides appropriate for the sample type must be used.
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Slides must be stained using the ThinPrep Stain according to the applicable ThinPrep®
Imaging System slide staining protocol.
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Slides should be clean and free of debris before being placed on the system.
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The slide coverslip should be dry and located correctly.
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Slides that are broken or poorly coverslipped should not be used.
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Slides used with the Genius Digital Imager must contain properly formatted accession
number identification information as described in the operator’s manual.
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The performance of the Genius Digital Diagnostics System using slides prepared from
reprocessed sample vials has not been evaluated.
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The monitor and graphics card for the Review Station are those supplied by Hologic
specifically for the Genius Digital Diagnostics System. They are required for proper
performance of the system and cannot be substituted.
WARNINGS
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For In Vitro Diagnostic Use
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The Digital Imager generates, uses, and can radiate radio frequency energy and may
cause interference to radio communications.
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Glass. The Digital Imager uses microscope slides, which have sharp edges. In addition,
the slides may be broken in their storage packaging or on the instrument. Use caution
when handling glass slides and when cleaning the instrument.
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Service Installation Only. The system must be installed by trained Hologic personnel only.
PRECAUTIONS
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Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of the