Konica Minolta REGIUS SIGMA2, Operation Manual

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66
Intr od uction
Thank you for purchasing the Direct Digitizer REGIUS SIGMA2 (called “this device” hereinafter) .
This device reads exposed X-ray image data saved to a plate within a cassette, then outputs it as diag -
nosis image data to the connected console .
In order to operate this device, either the medical image processing workstation ImagePilot or the CS-7
(called “Image processing controller” hereinafter), each of which control reception, processing, and output
of the image data of this device, is necessary . Concerning operation of the Image processing controllers,
please refer to the “Operation Manual” of each Image processing controller .
General X-ray images are the intended diagnostic images of this device. Mammographic images are not
included .
This manual covers cautions to be observed during usage, device operation methods, and cassette/plate
handling methods . Make sure to obtain a thorough understanding of the content within this manual, and
the Image processing controller operation manual, before using this device . Even after reading through
this manual, keep it stored near the device for reference to ensure that the device is used at maximum
efficiency.
* If this manual becomes illegible due to wear and tear, replace it with a new one . (fee required)
Summary of usability specifications (for IEC/EN 60601-1-6, IEC/EN 62366)
1) Medical purposes
• Provision of images for diagnosis of disease and injury.
2) Patient groups
• No patients groups that operate or touch the device.
• No identification of patient groups of read X-ray images.
3) Parts of body or organizations to which the device is mounted or that contact with the device .
• No appropriate points.(Device does not come in contact with the patient.)
4) Operating principle
• Insert the REGIUS cassette (hereinafter called the cassette) with a REGIUS plate (hereinafter
called the plate) inside which latent images were formed by X-ray exposure.
• The plate is pulled out from the opened tray, and while conveying the plate, scan the excitation la -
ser to the plate .
• Photostimulated luminescence emitted from the plate by the excitation laser is focused and detect -
ed, and detected signals are digitized and output as image data .
• By applying erase light to the plate scanned by the excitation laser, remaining latent images will be
erased .
• The plate is reloaded, which had its latent images erased, into the cassette. Take the cassette out
from the insertion slot .
5) Significant physical characteristics
• Refer to “ Specification”(p. 72) in the Appendix.
6) Significant performance characteristics
• Refer to “ Specification”(p. 72) in the Appendix.
7) User of this device
• There is no need for special training for using this device. This device is intended for the following users:
Healthy technicians of sound body who fully understand the information contained in this manual
and have specialized knowledge and a license (e .g ., doctors or radiological technologists) .