CONFIDENTIAL
VERSION
2.0
29 of 38
4.5.
Warranty
Nukute provides device 12month warranty for parts.
The warranty is void if:
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Collare is opened or modified
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Negligence of instruction for use
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Collare is used in environment that are not approved in this instruction for use
-
The device has been deliberately broken
4.6.
Compliance to Standards and classifications
Nukute holds an ISO 13485 certified Quality Management System which complies with the
requirements of the Medical Device Directive (MDD - Council Directive 93/42/EEC as
amended by Directive 2007/47/EC).
Nukute Collare is compliance with standard IEC 60601-1-2: Medical electrical equipment -
Part 1-2: General requirements for basic safety and essential performance - Collateral
Standard: Electromagnetic disturbances - Requirements and tests. Nukute Collare is
compliance also with Radio Equipment Directive 2014/53/EU.
Nukute Collare complies with RoHS Directive 2011/65/EU.
4.7.
Essential performance
When device appears to be working it must be able to store audio signals.
4.8.
Electromagnetic compatibility (EMC) information
Nukute Collare needs special precautions regarding Electromagnetic Compatibility (EMC),
and needs to be installed and put into service according to the EMC information detailed in
the section “Electromagnetic Compatibility (EMC) Information” of this manual.
Summary of Contents for Nukute Collare
Page 1: ...NUKUTE COLLARE MANUAL...