1 General Notes
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8
201000401000 / Rev 04
The implemented quality management system covers all aspects of the ergoline GmbH operations
as per EN ISO 13485.
All the cleaning and disinfection procedures described in this manual need to be carried out.
The assembly of ME systems and modifications during their actual operating life require the verifi-
cation of compliance with the requirements for electrical safety and of the essential performance.
The manufacturer and the competent authority of the member state where this ECG system is
used must be notified of all serious incidents involving the system which directly or indirectly led
or may lead to death or serious deterioration in the health of a patient.
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