Boston Scientific LATITUDE Series Patient Manual page 83

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resolved.
• This equipment has been tested and found to
comply with applicable safety portions of the EN
60601-1:2006 standard.
• This equipment has been tested and found
to comply with the following electromagnetic
compatibility (EMC) standard: EN 60601-1-
2:2007.
• Radio and Telecommunications Terminal
Equipment (RTTE). Boston Scientific hereby
declares that this device is in compliance with
the essential requirements and other relevant
provisions of Directive 1999/5/EC. To obtain
a full text Declaration of Conformity, contact
Boston Scientific using the information on the
back cover.
• Accessory equipment connected to the analog
and digital interfaces (signal inputs and signal
outputs) must be certified according to the
respective EN standards. Anyone who connects
additional equipment to the signal input parts
or signal output parts may configure a medical
system, and is therefore responsible that the
system complies with the requirements of
clause 16 of EN 60601-1:2006. If in doubt,
consult the technical service department or your
local representative.
LATITUDE
Communicator Patient Manual
79

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