PXS-710D Section 1
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1.6 COMPLIANCE NOTICE
The Source-Ray PXS-710D you have purchased has been designed,
manufactured, and calibrated to comply with the governing Federal Regulations
21 CFR Subchapter J. The maintenance schedules included are crucial to the
continued reliability of this equipment with respect to regulatory compliance.
CLASS I – INTERMITTENT MODE
PXS-710D SOURCE CONSISTING OF:
X-Ray Generator/ Tube Housing (PXS-710D-G)
Base Assembly
Remote Control Module (Optional)
INDICATION FOR USE:
The model PXS-710D Podiatry X-Ray source is intended for General Purpose
Radiographic exams utilizing film, computed radiography, or direct digital flat
panels. Not for mammographic use. Rx Only. Imaging Equipment is
Provided/Integrated by the end User.
SPECIFIED RANGE OF COMPLIANCE:
Tube Current: 10 mA
Tube Voltage: 40 - 70 kVp
Milliampere-second: 0.1 – 20 mAs
1.7
SAFETY STANDARDS
The Source-Ray PXS-710D you have purchased has been designed,
manufactured, and calibrated to meet the following safety standards;
Podiatry X-ray source with radiation protection in accordance with IEC 60601-
1-3:2008.
Podiatry X-ray source for radiography in accordance with IEC 60601-2-
54:2009.
X-ray tube assembly in accordance with IEC 60601-2-28:2010.
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