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MAGNAMED TECNOLOGIA MÉDICA S/A
15
Biocompatibility Declaration
We declare, under our sole responsibility, that all materials used in parts (as defined in standard NBR
IEC 60601-
1) of the Fleximag’s family have been widely used in the medical field over time, thus ensuring their
biocompatibility.
According to ISO-10993-1 Standard Biological evaluation of medical devices
— Part 1: Evaluation and
testing
– clause 5 – the ventilator, its parts and accessories are classified as a device without direct or indirect
contact with the patient’s body. Therefore, the ventilator, its parts, and accessories are not included in this
standard’s scope.
•
The common accessories acquired from third parties MUST comply with local legislation.
Содержание Fleximag
Страница 1: ...Operation Manual Mechanical Ventilator Fleximag display 15...
Страница 24: ...23 MAGNAMED TECNOLOGIA M DICA S A OK Item Assembly Sequence Image 8 Connect the power cord to the equipment...
Страница 84: ...83 MAGNAMED TECNOLOGIA M DICA S A DualPAP Dual Continuous Positive Airway Pressure...