i-CAT FLX V Series, Техническое руководство

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B-1
032-0328-EN Rev K
Appendix
B
Product Information
Essential Performance
The essential performance of the i-CAT imaging system is defined below:
•
The ability of the i-CAT system (including scanner controller, positioning system, and
imaging software) to capture 2D and 3D X-ray scans and reconstruct images suitable for
recognition of normal anatomical structures, dental pathologies, and abnormal
conditions, where inadequate images may result in misdiagnosis, subjecting the patient
to incorrect or unnecessary dental procedures that would present an unacceptable risk
to the patient.
•
The ability of i-CAT models to function reliably over the specified environmental and
input voltage requirements, provide electrical isolation of the patient from mains
voltages, have low leakage current, and control the motion system where inability to
meet these requirements can result in electrical shock resulting in injury or death, injury
due to collision caused by loss of motion control, or require an additional re-scan
because of equipment malfunction that will increase the risk of serious illness and
present an unacceptable risk to the patient.
•
The ability of i-CAT models to provide mechanical safety and stability to provide
optimum and consistent images, avoid any injury to the patient, and prevent the need for
a re-scan that would present an unacceptable risk to the patient.
•
The ability of i-CAT models to meet electromagnetic compatibility requirements for
emissions and susceptibility where inability to meet EMC performance requirements
could result in possible degraded performance, inaccurate or distorted images, or
interference with other medical equipment resulting in incorrect or unnecessary dental
procedures or malfunction of other electrical equipment that would present an
unacceptable risk to the patient.
•
The ability of i-CAT models to meet radiation performance and protection requirements
where inability to meet these requirements can result in increased dose to patient or
inadequate images that result in misdiagnosis, subjecting the patient to incorrect or
unnecessary dental procedures that would present an unacceptable risk to the patient.
User Proficiency
The i-CAT is designed to be operated by healthcare professionals who are educated and
competent in the techniques described in the accompanying documentation. Specific educational
requirements are determined by state and/or national regulatory agencies. Operators are strongly