3.3 regulatory compliance

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Designed and manufactured in accordance with IEC 60601-1 Ed. 3.0 (2005) + Amd. 1 (2012) + Amd. 2 (2020) and its collateral standards 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, and IEC 60601-1-11 Ed. 2.0 (2015) + Amd. 1 (2020).

Additional details can be requested via technical support.

1 3.4.1 510k clearance
2 3.4.2 biocompatibility
3 3.4.3 classification
4 3.4.4 telecommunication

3.4.1 510k clearance

The B4C System is cleared under FDA 510k numbers K201989 | K240821.

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3.4.2 biocompatibility

Sensors 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..

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3.4.3 classification

Type BF equipment designed for continuous operation. Powered internally and externally through batteries only. Classified as Risk Class II in accordance with CFR Title 21. Includes a Class II protection power adapter and charger.

Equipment classification in accordance with applicable standards

Equipment classification in accordance with applicable standards
Protection against electric shock	Internally powered equipment
Degree of protection against electric shock	Applied Part – Type BF
Degree of protection against harmful water penetration	IPX0 (no protection against harmful water penetration)
Sterilization or disinfection methods	Sterilization not applicable. Disinfection with 70% alcohol or 2% chlorhexidine
Degree of application safety in the presence of FLAMMABLE ANESTHETIC MIX	Not suitable for use in the presence of FLAMMABLE ANESTHETIC MIXTURE with air, oxygen or nitrous oxide
Operation mode	Continuous Operation Equipment

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3.4.4 telecommunication

This equipment has been tested under the specifications of FCC 47 CFR Part 15 Subpart C, §15.209 Radiated Emission Limits, and General Requirements RSS-GEN, Issue 4, Nov. 2014, Section 8.9. It 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 user guide, may cause harmful interference to radio communications. Operation in a residential area is likely to cause harmful interference, in which case the user will be required to correct the interference at their own expense.

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