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9. Technical Specifications
IMPORTANT
This device complies with Part 15 of the FCC Rules. Operation is
subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including
interference that may cause undesired operation.
Declaration of Conformity
Conformance to Standards
– non-clinical testing demonstrated
conformance to voluntary Safety standard IEC 60601-1:1998
(with Amendments 1 & 2)
and to EMC standard IEC 60601-1-2:2001 Class B
Card Guard’s Quality System conforms to ISO-9001:2008,
ISO 13485:2003, and complies with CE MDD requirements
Tested for compliance with FCC 47 CFR Part 15,
subpart B and subpart C
