Terapio+ KTR-2230 Manual Del Usuario página 19

And Medical Electrical Systems Used In The Home
Healthcare Environment.
3. IEC 60601-2-10: 2013 Medical electrical equipment
- Part 2-10: Particular requirements for the safety of
nerve and muscle stimulators.
4. IEC 60601-1-2:2014 Medical Electrical Equipment
- Part 1-2: General Requirements For Basic Safety
And Essential Performance - Collateral Standard:
Electromagnetic Disturbances - Requirements And
Tests.
Appendix EMC Declaration
The equipment is intended for use in the electromagnetic
environment specified below.
The customer or the user of the EQUIPMENT should
assure that it is used in such an environment.
The Transcutaneous Electrical Nerve and Muscle
Stimulators is suitable for use in a professional health
care environment, not including areas where there are
sensitive equipment or sources of intense electromagnetic
disturbances, such as the RF shielded room of an imaging
system magnetic resonance imaging, in operating rooms
near active AF surgical equipment, electrophysiology
laboratories, armored rooms or areas where short wave
therapy equipment is used.
• Do not use the system around strong electric filed,
electromagnetic filed (e.g. MRI scan room) and mobile
wireless communication devices. Using the device in
an improper environment may cause malfunction or
damage.
• The compliance with EMC and EMI regulation cannot be
guaranteed by the use of modified cables or those which
does not comply with the same standards under what
the equipment was validated.
• The system must not be used adjacent or supported by
other equipment. The recommendations of this manual
must be followed.
• Do not use accessories, transducers, internal parts
of components and other cables other than those
previously specified by the manufacturer. This may result
in increased emission or decreased electromagnetic
immunity and result in improper operation.
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