Quantum QT-730 Series Installation And Operation Manual page 8

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
Diagnostic X-Ray System" by the Assembler (i.e., the installer) with the appropriate
agencies; 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 also completed by the installer and returned
to Quantum 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 Shield-
ing 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, participate in or supervise the operation of the equipment must be thoroughly
familiar and comply completely with the currently established safe exposure factors
and procedures described in publications such as Subchapter J of Title 21 of the
Code of Federal Regulations, "Diagnostic X-Ray Systems and Their Major Compo-
nents," and NCRP Report No. 102, "Medical X-Ray, Electron Beam and Gamma Ray
Protection for Energies 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 per-
formance to the regulatory standard is incumbent upon the user's diligent confor-
mance 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 mix-
ture with air or with oxygen or with nitrous oxide.
The following symbols may be used for marking on this equipment or equipment
documentation:
Earth (ground)
Protective Earth (ground)
vi
MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE,
MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH CAN/CSA C22.2 NO. 601.1
98YA
MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE,
MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH UL 2601-1
98YA
Type B equipment
Attention, consult accompanying documents
Model QT-730 Radiographic Table
NOTE
Form FD-2579
is required for
U.S. installa-
tions; please
observe the
applicable
regulations of
your particular
local and/or
national agen-
cies.