Europe - Eu Declaration Of Conformity - ACE Solution Einthoven CR1000 User Manual

Health sensation system
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❑ This Product Complies with the following Requirements in Administrative
Regulations on Low Power Radio Waves Radiated Devices in Taiwan
◎ Art.12: Without permission granted by the NCC, any company, enterprise, or
user is not allowed to change frequency, enhance transmitting power or alter
original characteristic as well as performance to a approved low power radio-
frequency devices.
◎ Art. 14: The low power radio-frequency devices shall not influence aircraft
security and interfere legal communications; If found, the user shall cease
operating immediately until no interference is achieved.
The said legal communications means radio communications is operated in
compliance with the Telecommunications Act.
The low power radio-frequency devices must be susceptible with the
interference from legal communications or ISM radio wave radiated devices.
❑ Europe – EU Declaration of Conformity
This device complies with the essential requirements of the Radio Equipment
directive: 2014/53/EU. The following test methods have been applied in order
to prove presumption of conformity with the essential requirements of the
Radio Equipment directive:
➢ 2014/53/EU
➢ IEC 60601-1
➢ IEC 60601-1-2
➢ IEC 60601-1-11
➢ IEC 60601-2-47
The minimum distance between the user and/or any bystander and the
radiating structure of the transmitter is 20 cm.
➢ EN 300 328
➢ EN 301 489-17
➢ FCC 47 CFR Part 15B
➢ FCC 47 CFR Part 15C
➢ LP0002
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