RUN EXCITE-2008: Service & Maintenance Manual - rev. 1.3
Page 2.5
2.5.
CONFORMITY TO REGULATIONS
Europe
Medical Europe
USA
Standards
EN60335-1
EN61000-6-1
EN55022 classe A
EN61000-3-2
EN61000-3-3
EN957-1
EN957-6 classe SB
EN60601-1
EN60601-1-2
EN957-1
EN957-6 classe SB
UL 2601-1
FCC15
Directives
73/23/CEE
89/336/CEE
98/37/CEE
93/42/CEE
Inoltre:
•
Risk category under 93/42/CEE :
Class IIA
;
•
Electrical isolation class under EN60601-1:
Class I;
•
Applied parts:
Type B
(not for European models)
;
•
Applied parts of the heart rate monitor transmitter:
Type BF
;
•
Protection rating:
IP20.
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