Shenzhen Creative Industry Co. Oxy-One Plus Mode D'emploi page 49

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Part 2-61: Particular requirements for basic safety and
essential performance of pulse Oximeter equipment.
And it also follows the provisions of the council
directive MDD 93/42/EEC.
Caution: U.S. federal law restricts this device to sale or use
by or on the order of a physician.
VII

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