Section 1.0
MAN 06–0017H ZIEHM QUANTUM User’s Manual Page 14 of 220
1.4 EQUIPMENT OWNER RESPONSIBILITIES
The Equipment Owner is responsible for ensuring that the x-ray system complies with the
applicable sections of CFR 21, Subchapter J - Radiological Health. Compliance is periodically
verified by subjecting the system to various test procedures defined by the Center for Disease and
Radiological Health (CDRH).
The Equipment Owner is responsible for ensuring that only persons who are trained and qualified
are allowed to operate the x-ray system.
When required, System Users must obtain credentials from local, state, and federal authorities
before operations of the device.
If the system fails to operate correctly, or fails to respond to system controls as outlined in this
manual, notify the local, authorized Ziehm Imaging, Inc. dealer representative.
1.5 HOSPITAL ADMINISTRATION
Hospital Administration is responsible for verifying that the equipment continues to operate
within the correct calibration of mA, kV, time/mAs, and alignment of the useful beam.
Hospital Administration is responsible for ensuring that the system complies with applicable
local, federal, statutory, and regulatory requirements. Hospital administration is responsible for
consulting with local, state, and federal agencies regarding requirements and regulations
applicable to the system’s use.
Ziehm Imaging, Inc. assumes no responsibility or liability for after-sale operating and safety
practices and is not responsible for personal injury or damage resulting from the misuse of its
systems.
If you have any safety-related questions, contact your authorized Ziehm Imaging, Inc. dealer
representative.
1.6 MANUFACTURER
The manufacturer is responsible for the safety, reliability and efficiency of the equipment only
when:
• Installation, alterations or repairs are carried out by persons authorized by the manufacturer.
• The electrical installation in the room in which the ZIEHM QUANTUM is used
corresponds to the power requirements listed in Appendix A.
• The equipment is used in accordance with this manual and the operator follows said manual.
1.7 EXCLUSION OF LIABILITY
The manufacturer accepts responsibility for the safety, reliability and performance of the system
only if;
• Any installation, modification or repair work is carried out exclusively by persons
authorized by the manufacturer;
• The electrical installation of the room where the system is operated complies with the
requirements of VDE 0107, or the corresponding national regulations of the respective
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