Medical equipment biocompatibility standards ISO 10993-10: 2010, EN ISO 10993-10: 2013 and ISO 10993-5: 2009.
Designed and manufactured in accordance with ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012 + Emend 1 (2016) and its side standards IEC 60601-1-2: 2014, ABNT NRB IEC 60601-1-6:2011 (identical to IEC 60601-1- 6: Ed.1.1b:2013), ABNT NRB IEC 60601-1-9:2014 (identical to IEC 60601-1-9 ED. 1.1 B:2013) and ABNT NBR IEC 60601-1-11:2012 (identical to IEC 60601-1-11:2010).
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.
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.
Table 3.4-1 - Equipment Classification
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 |