Regulatory Compliance - Quantum QT-740 Operator's Manual

Chapter 1 Safety Notices

REGULATORY COMPLIANCE

This certified Quantum Medical Imaging, LLC medical device has been designed,
manufactured, and calibrated to comply with governing Federal Regulations 21 CFR
Subchapter J and the performance standards attendant thereto. Upon installation, all
certified products require the filing of Form FD-2579 "Report of Assembly of a Diag-
nostic X-ray System" by the assembler (i.e., the installer) with the appropriate agen-
cies; the "Installation Quality Assurance Checklist" must also be completed and
properly distributed upon installation. A copy of each form (pink copy) is provided to
the user. The installation report is completed by the installer and returned to Quan-
tum Medical Imaging, LLC.
Those responsible for the planning of x-ray equipment installations must be thor-
oughly familiar and comply completely with NCRP Report No. 49, "Structural Shielding
Design and Evaluation for Medical Use of X-Rays and Gamma Rays of Energies up to
10 MeV", as revised or replaced in the future. Those authorized to operate, test, par-
ticipate in or supervise the operation of the equipment must be thoroughly familiar
and comply completely with the currently established safe exposure factors and pro-
cedures described in publications such as Subchapter J of Title 21 of the Code of Fed-
eral Regulations, "Diagnostic X-Ray Systems and Their Major Components," and NCRP
Report No. 102, "Medical X-Ray, Electron Beam and Gamma Ray Protection for Ener-
gies Up to 50 MeV—Equipment Design and Use" as revised or replaced in the future.
Scheduled maintenance is essential to the assurance of continued integrity of this
equipment with respect to regulatory compliance. The continuance of certified perfor-
mance to the regulatory standard is incumbent upon the user's diligent conformance
to recommended maintenance instructions.
This product has been classified as Class I, Type B by Underwriters Laboratories, Inc.
Equipment not suitable for use in the presence of a flammable anesthetic mixture
with air or with oxygen or with nitrous oxide.
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Models QT-740 & QT-750 - Operator's Manual