XVIVO 11.01.201, Инструкция по эксплуатации

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11.01.601.7c EN Page 33 of 40
The Liver Assist is subject to the European directive 2012/19/EU on waste electrical and
electronic equipment (WEEE). Do not dispose the device yourself. If users in the European
Union wish to discard the device at the end of its useful life, contact XVIVO to arrange a
retrieval of your Liver Assist. XVIVO shall ensure that your discarded product undergoes the
necessary treatment, recovery and recycling procedures free of charge.
For disposal in countries outside of the European Union, local regulations must be followed
for the disposal of the Liver Assist.
Classification to 93/42/EEC Class IIa
Classification to IEC 60601-1 Class I
Classification to IEC 62304 Class A
Protection against electrical shock Type B
Directive(s):
Council Directive 93/42/EEC annex II
Standard(s):
•
Safety International Standard IEC 60601-1
•
EMC International Standard IEC 60601-1-2
•
Software International Standard IEC 62304
•
Usability International Standard IEC 62366
•
Risk Analysis International Standard ISO 14971
•
Quality International Standard ISO 13485
Notified body: BSI (NL)
Say Building
John M. Keynesplein 9
1066 EP Amsterdam
The Netherlands