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M
anatec
B
iomedical
21, Rue du stade, Petit Ebersviller
▪
57730 Folschviller
▪
France
Tél : +33 (0)3 72 82 50 00
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Fax : +33 (0)1 30 74 46 48
Service Manual PhysioFlow Lab1
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Version of Monday, 10 July 2017
Appendix A: Legislation
Computer must comply with regulations concerning medical devices (Desktop computer, or laptop with
leakage current under 0.1 mA). Please refer to the manufacturer information.
Please connect PhysioFlow® to a CE marked device, compliant with medical norms.
LEGISLATION
:
CE marking in accordance with EC directive 93/42/CEE concerning medical devices (class II A).
Device approved by the Japanese Ministry of Health.