10
Classification and Compliance with Standards Model ECHO-FT manufactured by
Jawon medical is classified as;
-
ECHO-FT is specified as Class 2 type BF unit under the standard of
IEC60601-1 (Safety of Medical Electrical Equipment).
-
Internally powered equipment (Battery : 4 × LR6-AA)
-
Ordinary equipment without protection against ingress of water
-
Equipment not suitable for use in presence of a flammable anesthetic
mixture by standard of IEC60601-1 (Safety of Medical Electrical Equipment)
-
Equipment that complies with Class B for Noise-Emission, Level B for
Noise-immunity
by
standard
of
IEC60601-1-2
(Electromagnetic
Compatibility Requirements)
-
This blood pressure meter complies with the EN1060-1 : 1995 Non-invasive
Sphygmomanometers general requirements as well as EN1060-3 : 1997
supplementary requirements for electro-mechanical blood pressure
measuring system.
CLASSIFICATION & COMPLIANCE WITH STANDARD
NOTE
1.Jawon's accessory equipment connected to the analog and digital interfaces
are certified according to the respective IEC standards.
(e.g. IEC 950 for data processing equipment, ICE 601-1 for medical
equipment and system standard EN 60601-1-1:1993)
2. When recycling and proper diapose after their useful lives, the device shall
be disposal in accordance with national laws.