Reference to standards

• EN ISO 80601-2-56:2017 — Clinical thermometers: basic safety and essential performance.
• EN 60601-1:2006+A1:2013 — Medical electrical equipment: general requirements.
• EN 60601-1-2:2015 — Electromagnetic disturbances: requirements and tests.
• EN 60601-1-11:2015/A1:2021 — Home healthcare environment requirements.

Regulatory compliance

• European Regulation on medical devices EU MDR 2017/745.
• European RED Directive 2014/53/EU (radio equipment).

Electromagnetic compatibility

The device complies with the applicable EMC requirements. It is designed for use in the home healthcare environment. Electromagnetic disturbances may still occur in some environments — see Electromagnetic Interference and Defibrillation for the recommended separation distances and precautions.

Manufacturer

Baby FM, Veljka Dugosevica 54, 11000 Beograd, Serbia. Device type BFM-01. Expected service life 5 years.