BIOFLEX Therapist - Classification

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Classification
The system is classified as a medical device. Furthermore, it is in
accordance to the Sub-clause 6 of IEC 60601-1 and Clause 6 of
IEC 60601-1:2005:
• CLASS I EQUIPMENT, according to the type of
protection against electric shock;
• TYPE B APPLIED PART, according to the degree of
protection against electric shock;
• NOT CLASSIFIED, according to the degree of
protection against harmful ingress of water;
• CONTINUOUS OPERATION, according to the mode
of operation;
• NONE OF THE PARTS OF THE SYSTEM ARE STERILIZED.
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