Designed and manufactured in accordance with IEC 60601-1 Ed. 3.0 (2005) + Amd. 1 (2012) + Amd. 2 (2020) e suas normas colaterais IEC 60601-1-2 Ed. 4.0 (2014) + Amd. 1 (2020), ABNT NBR IEC 60601-1-6:2020, ABNT NBR IEC 60601-1-9:2014 e IEC 60601-1-11 Ed. 2.0 (2015) + Amd. 1 (2020).

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

3.4.1 biocompatibility

The modules BcSs-PICNIW-1000 and BcSs-PICNIW-2000 have passed biocompatibility tests in accordance with standards NBR IEC 60601-1, ISO 10993-10:2010, EN ISO 10993-10:2013 e ISO 10993-5:2009..

3.4.2 classification

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

Table 3.4-1 - Equipment Classification

3.4.3 telecommunication

Equipment tested under specification FCC 47 CFR Part 15 Subpart C, §15.209 Radiated emission limits and General requirements RSS-GEN, Issue 4, Nov.2014, section 8.9 Contains FCC ID: 2AA9B04

Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.