Well Health WH-CP Manual Del Propietário página 132

3) Medical electrical equipment - Part 2-10: Particular requirements for the safety
of nerve and muscle stimulators (EN60601-2-10:2015)
4) Medical electrical equipment - Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic compatibility -Requirements and tests
(EN60601-1-2:2015)
XI. Appendix
The Transcutaneous Electrical Nerve Stimulator is intended for use in the
electromagnetic environment specified below. The buyer or user of the
Transcutaneous Electrical Nerve Stimulator should assure that it is used in
such an environment.
Emission test
RF emissions
CISPR 11
RF emission
CISPR 11
Harmonic
emissions
IEC 61000-3-2
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Guidance and manufacture's declaration
– electromagnetic emission
Compliance Electromagnetic environment – guidance
Group 1
The Transcutaneous Electrical Nerve Stimulator
use RF energy only for its internal function.
Therefore, its RF emissions are very low and
are not likely to cause any interference to nearby
electronic equipment.
Class B The Transcutaneous Electrical Nerve Stimulator
is suitable for use in all establishments, including
domestic establishments and those directly
N/A connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.
N/A