CSO COBRA HD - Medical Device Classification

INSTRUCTIONS FOR USE
COBRA HD | IFUCOBRAHDEN00
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The accessories must be compliant to the norm IEC 60950-1
Information technology equipment - Safety -
Part 1: General
requirements.
If the accessories are installed in the patient area it is necessary to
install an isolation electrical supply compliant wi
th the directive IEC
60601-1:2005 + A1:2102 - "Medical electrical equipment -
Part 1:
General requirements for basic safety and essential performance".
Patient area: any volume in which intentional or unintentional
contact can occur between patient and
parts of the system or
between patient and other persons touching parts of the system.
Fig 5 - Patient area
2.4 MEDICAL DEVICES CLASSIFICATION
Technical data
Value
Classification in compliance with the
attached IX to the Directive
93/42/EEC and subsequent
modifications
Class IIa