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Designed and manufactured in accordance with IEC 60601-1 Ed. 3.0 (2005) + Amd. 1 (2012) + Amd. 2 (2020) e suas normas colaterais 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 e , and IEC 60601-1-11 Ed. 2.0 (2015) + Amd. 1 (2020).
Additional details can be requested at brain4care (www.brain4.care).via technical support.
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3.4.1 510k clearance
The B4C System is cleared under FDA 510k numbers K201989 | K240821.
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3.4.
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2 biocompatibility
The modules 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.
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3 classification
Equipment type BF. Continuous Type BF equipment designed for continuous operation. Internal Powered internally and external power externally through batteries only. Classified as Risk Class II , in accordance with CRF CFR Title 21. It accompanies Includes a Class II protection class II power adapter and charger.Table 3.4-1 -
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Equipment classification in accordance with applicable standards | |
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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.
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4 telecommunication
Equipment This equipment has been tested under specification the specifications of FCC 47 CFR Part 15 Subpart C, §15.209 Radiated emission limits Emission Limits, and General requirements Requirements RSS-GEN, Issue 4, Nov. 2014, section Section 8.9 Contains . 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 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 manualuser guide, 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 their own expense.