Intended Use/ Essential Performance/ Application Specification; Intended Use; Essential Performance; Application Specification - Konica Minolta SKR 4000 User Manual

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Sync-shot exposure trigger
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CsI scintillation screen.
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Easy to change the cable and update firmware.
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Battery recycling

2.4. Intended use/ essential performance/ application specification

2.4.1. Intended use

SKR 4000 Wireless Digital Flat Panel Detector is indicated for digital imaging solution
designed for providing general radiographic diagnosis of human anatomy. It is intended to
replace radiographic film/screen systems in all general-purpose diagnostic procedures. This
panel provides digital X ray imaging for diagnosis of disease, injury, or any applicable health
problem. The image is obtained as the result of X ray passing through the human body and
detected by detector.
KINOCA would provide hardware and software support for integration of system.
This panel is not intended for mammography and extra-oral X-ray applications which are
covered by IEC60601-2-63.

2.5. Essential performance

According to the SKR 4000 series intended use and the result of risk management, getting
imaging and function of data transmission is defined as essential performance.
Getting qualified dark image proves that essential performance does not influence intended
use. Method for getting dark image in detail refers to section "install" and "operation".
2.5.1.

Application specification

PATIENT population:
Age: except for children
Weight: not relevant
Health: not relevant
Nationality: multiple
Patient state: patient is not user
Gender: except for pregnant women
Intended OPERATOR:
All of use, maintenance and operation steps should be carried out by the operator who has
accepted the professional training offered by the company's customer service staff.
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General Description
KONICA MINOLTA,
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