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FDE SO-CONNECT PID - Compliance and Classification

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Partie I Description of pump and accessories
12
Compliance and classification
This manual has been prepared in accordance with the requirements of standard IEC 60601-2-24 relating to medical electrical equipment
Part 2-24: Particular requirements for the safety of infusion pumps and controllers. The data stated in part VI - Technical specifications - are
based on the specific test conditions defined in that standard. Actual performance data may differ from the stated data depending on other
external factors, particularly variations in counter-pressure, temperature, use of the infusion kit, viscosity of the solution or a combination of
these factors.
The SO
CONNECT PID pump is classified as follows:
class IIb medical device,
type BF applied part,
classified for continuous operation.
The SO
CONNECT PID pump has a protection rating of IPX2:
no protection against solid objects,
protected from dripping water when tilted at 15° maximum.

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