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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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