Use Instructions

7
No Latex used
No PVC used
Temperature limitation
The Novii system is not to be taken into a Magnetic Resonance (MR) environment
FCC ID: YOM-
6961-MON
Federal Communication Commission identification number. Complies with United States
Radio communication requirements.
1.2 Standards
The Monica Novii Interface complies with the following safety standards
Standard
Description
IEC 60601-1:2005 +A1: 2012 incl.
USA deviations
Medical Electrical Equipment
Part 1: General requirements for basic safety and essential
performance
IEC 60601-1-2:2007
Medical Electrical Equipment Part 1-2
General Requirements for basic safety and essential performance –
Collateral standard: Electromagnetic compatibility – requirements and
tests
EN ISO14971: 2012
Medical Devices – Application of risk management to medical
devices (ISO 14971:2007, Corrected version 2007-10-01)
ANSI /AAMI EC12
Disposable ECG electrodes
EN 62133: 2nd Edition 2012
Secondary cells and batteries containing alkaline or other
non-acid electrolytes – Safety requirements for portable sealed
secondary cells, and for batteries made from them, for use in portable
applications
EN ISO 10993
Biological evaluation of medical devices
FCC CFR 47: Part 15.107 & 15.109
Title 47--Telecommunication
Chapter I – Federal Communications Commission 15 – Radio
Frequency devices
EN 60529:1992 +A2:2013
Specification for degrees of protection provided by enclosures
(IP code)
EN ISO 15223-1:2012
Graphical Symbols for use in the labelling of medical devices