Regulatory Information - Cortrium C3+ Instructions For Use Manual

Single use / reusable
Recording standard
Recording format
Intended placement
Recording period

6.2 Regulatory information

The C3+ is a class IIa medical device according to 93/42/EEC. The C3+ complies with the following
product standards:
DS/EN 60601-1-1
DS/EN 60601-1-2
DS/EN 60601-1-6
DS/EN 60601-1-11
DS/EN 60601-2-47
DS/EN 62366-1
DS/EN ISO 10993-1
DS/EN ISO 15223-1
DS/EN 1041
DS/EN 62304
DS/EN ISO 14971
EN 301 489-17 V3.1.1
EN 300 328 V2.1.1
C3+ IFU - 0723 01140 (70048) UK
Safety Requirements for Medical Electrical Systems
Electromagnetic Disturbances
Medical Electrical Usability
Home Healthcare Environment
Particular requirements for the basic safety and essential
performance of ambulatory electrocardiographic systems
Application of usability engineering to medical devices
Biological evaluation of medical devices
Symbols to be used with medical device labels, labelling and
information supplied
Information supplied by the manufacturer of medical devices
Medical device software – software life cycle processes
Application of risk management to medical devices
Electromagnetic Compatibility (EMC) standard for radio
equipment and services; Part 17
Wideband transmission systems; Data transmission equipment
operating in the 2,4 GHz ISM band
Reusable/Rechargeable Monitor
Holter
Continuous
Midsternal line
Up to 7 days on a single charge
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