back to index | back to introduction
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 at brain4care (www.brain4.care).via technical support.
| Anchor | ||||
|---|---|---|---|---|
|
| Table of Contents | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
...
3.4.1 510k clearance
The B4C System is cleared under FDA 510k numbers K201989 | K240821.
...
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..
...
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 | |
|---|---|
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 |
...
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.
...