PXS-710D Section 1
11
1.5.1 CONTINUED:
[ESSENTIAL PERFORMANCE]
The ME Equipment, PXS-710D, shall be able to perform its Essential
Performance and remain safe. The following degradation associated with
Essential Performance shall not be allowed:
Expose Loading Parameters KV, mA, Time and mAs set on the
operator control panel (OCP) shall not be different than actual output
of X-Ray generator KV, mA and mAs, Time. (Within tolerance of each
loading parameter)
Reproducibility and Linearity of radiation output shall meet IEC
60601-2-54 requirement.
The X-ray Generator shall protect the X-Ray tube exceeding its safety
limits required by tube manufacture.
With customer supplied Digital Imaging Panels: Performance of the
PXS-710D shall provide image quality acceptable for medical
diagnostic. The PXS-710D is designed to power one Digital Imaging
Panel at a time.
“WARNING: Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in improper
operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating
normally.”
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