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Virhe. Määritä Aloitus-välilehdessä Heading 1;Pääotsikko, jota haluat käyttää tähän kirjoitettavaan tekstiin.
8. Regulatory information
8.1 Classification EU
In accordance with MDD 93/42/EEC:
Class IIa product
EN60601-1:
Internally powered equipment
8.1.1 Declaration of Conformity
We herewith declare under our sole responsibility that the product listed below is in conformity with
the provisions of the Council Directive 93/42/EEC of 14 June 1993 (and the Finnish national laws
1505/94 and 1506/94) concerning medical devices. When used with external evaluation software
this declaration of conformity is valid for the Faros hardware.
Trade Name:
Faros Product Family
Model(s):
eMotion Faros 90
eMotion Faros 180
eMotion Faros 360
MDD Classification:
Class IIa
Following standards were used to meet requirements:
EN60601-1 3
rd
edition (IEC601-1 3
rd
ed.) Medical electrical equipment. Part 1: General requirements for safety
EN60601-1-2 3
rd
edition (IEC601-1-2 3
rd
ed) Medical electrical equipment. General requirements for safety. 2. Collateral
Standard. Electromagnetic compatibility - Requirements and safety
ECG functions are evaluated using relevant parts of the EN60601-2-25 (IEC601-2-25) standard taking into account the
intended use of the device.
According to the manufacturer of the Bluetooth modules: The Bluetooth modules meet the requirements of the EMC Directive
89/336/EEC as amended by Directives 92/31/EEC and 93/68/EEC within CE marking requirement.
8.1.2 Intended Use
The eMotion Faros ECG Sensor is a wearable, portable, externally applied, electrocardiograph
recorder and transmitter for the purpose of health monitoring, biofeedback and scientific research.
The eMotion Faros is intended for use in clinical and non-clinical settings to collect and transmit
health parameters to healthcare professionals, scientists and researchers for monitoring and
evaluation.
The eMotion Faros does not provide any automatic analysis or diagnosis.
