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Comment: Renumbered to 3.3 because FDA requested Warnings be moved up earlier in document on 10/6

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Additional details can be requested at brain4care (www.brain4.care).

3.4.1 biocompatibility

The module BcSs-PICNIW-1000 is registered with Anvisa and has passed biocompatibility tests in accordance with NBR IEC 60601-1, ISO 10993-10, EN ISO 10993-10 and ISO 10993-5.

3.4.2 classification

Equipment, Type BF. Continuous operation. Internal and external power through batteries only. Risk Class I, in accordance with CRF Title 21. It accompanies a class II power adapter and charger.

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