Siemens MAMMOMAT NovationDR, Installation Instructions Manual, Page: 13 / 95

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February 5, 2004
FFDM-S Service Manual
Detector Safety and Compliance Information
Environment
The operating environment is 20° to 35°C (68° to 95°F), 10 to 80% Relative
Humidity (non condensing). Make sure the ventilation openings at the rear of the
detector are not obstructed. For storage and transportation, the temperature range
must stay within 10° to 40°C (50° to 104°F) or permanent damage may occur. Such
damage could be considered misuse and may not be covered under warranty.
Do not autoclave this equipment.
Certification
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 FFDM-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
FFDM-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 FFDM-S is intended
to be installed as part of x-ray equipment and serviced only by persons trained and
approved to work on that specific equipment, using the appropriate tools.
Classification
With reference to subclause 5 of IEC 60601-1:
•
Protection against electric shock (5.1, 5.2) Class I.
•
Applied Parts: Type B Applied Parts.
•
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.