8
All instuctions concerning operations during which
X-rays are emitted will be preceded by this symbol
to remind the user of the precautions to be taken,
as recommended by local regulations.
General precautions for protection against X-rays.
• Operator control X-ray emission from a distance of
at least 6 feet from the focal spot of the X-ray.
• Reduce the radiation level to which patients and
operating personnel are exposed.
• During X-ray emissions, only the operating
personnel and the patient should be present.
• The veterinarian should wear a protective apron,
etc., when necessary.
A1.5 Compliance with current USA and International standards and
regulations
CDRH/FDA
The components of this device have been certified by the
manufacturer to be in compliance with FDA regulations as per 21
CFR SUBCHAPTER J as ammended, for veterinary applications.
This model is not for human use.
International X-ray Standards
CEI 62-5+A11+A12+A13+Amend.2
General safety regulations concerning electrical medical
equipment.
CEI 62-67
Safety standards for X-ray tubeheads.
CEI EN 60601-1-2
Additional safety regulations concerning electro-magnetic
compatibility: Recommendations and testing.
CEI EN 60601-1-3
General safety regulations.
General recommendations for protection against X-rays when the
equipment is used for diagnostic purposes.
CEI EN 60601-1-4
General safety regulations for SW logic programmable equipment.
CEI EN 60601-2-28
Specific safety regulations for X-ray equipment and tube assemblies
for medical diagnostics.
Summary of Contents for IMAGE-VET 70 ACP
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