Medivon KTR-2610 Manual Del Usuario página 28

13. Executive Standards
The product conforms to the following standards and laws:
1. IEC 60601-1:2005+A1: 2012 Medical electrical equipment - Part 1:
General requirements for basic safety and essential performance
2. IEC 60601-1-11: 2015 Medical Electrical Equipment - Part 1-11:
General Requirements For Basic Safety And Essential
Performance - Collateral Standard: Requirements For Medical
Electrical Equipment 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 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.