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PXCM Safety and Compliance Information
Environment
Certification
Classification
Warnings and Cautions
Introduction
The operating environment is 10
Humidity (non condensing).
UL Recognized Component certified to be in compliance with applicable
requirements of:
•
UL 2601-1, Second Edition including Amendments 1 and 2
•
CAN/CSA C222 No. 601.1-M909
Use of the PXCM-S with equipment not complying with equivalent safety
requirements may lead to a reduced level of safety in the resulting system. There
must be evidence that added equipment has been certified for safety in accordance
with the appropriate IEC 601-1 and/or IEC 601-1-1 harmonized national standard.
Otherwise use within the defined Patient Vicinity is not approved. Testing of the
PXCM-S in combination with the end use equipment shall include leakage current
test, ground continuity tests, temperature tests and other tests as required by the
appropriate standards. The maximum operating temperatures of certain safety
components, as defined in the applicable safety standards, must not be exceeded in
the end use installation to maintain the intended safety. The PXCM-S is intended
to be installed within X-ray equipment and serviced only by persons trained and
approved to work on that specific equipment, using the appropriate tools.
With reference to subclause 5 of IEC 60601-1:
•
Protection against electric shock (5.1, 5.2) Class I.
•
Protection against harmful ingress of water (5.3) Ordinary.
•
Degree of safety in the presence of flammable anesthetics or oxygen (5.5). Not
suitable for use in the presence of flammable anesthetics or oxygen.
•
Mode of Operation (5.6): Continuous.
WARNING Dangerous Voltages are present on some components, printed wiring traces,
and heatsinks. A blown fuse is an indication of a catastrophic failure of circuit
components. Unauthorized replacement may result in a risk of fire.
CAUTION This unit includes a lithium battery. Do not attempt to disassemble or
recharge it. Do not dispose of the battery in fire.
to 50
C (50
to 122
F), 10 to 80% Relative
°
°
°
°
February 5, 2004
1-7
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