19 800 0002 12.2020
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Technical Specifications and Conformity
8.2 Type plates
8.3 Conformity with directives
8.4 Conformity with standards
This device complies with the applicable standards EN/IEC 60601-1, CAN/CSA-C22.2
No.601.1, UL Std. No 60601-1.
The requirements from the device safety ("essential performance") standard in accor-
dance with IEC 60601-1, 3
rd
edition:
– The device MASTERPULS
®
ONE is free of excessive pressure wave energy.
have been fulfilled.
Essential performance for basic safety cannot be impaired by electromagnetic interfer-
ence.
Fig. 8-1 230 V type plate
Fig. 8-2 115 V type plate Fig. 8-3 100 V type plate
This medical product bears the CE mark in accordance with the Medi-
cal Device Directive (MDD) 93/42/EEC.
Acc. to EN/IEC 60601-1
– Type of protection against electric shocks
Protection class 2
with functional
earth
– Applied part of type BF
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