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Idiomas disponibles
14.Executive Standards
The product conforms to the following standards and laws:
IEC 60601-1:2005+A1：2012 Medical electrical equipment-Part 1:
General requirements for basic safety and essential performance
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
IEC 60601-2-10：2013 Medical electrical equipment - Part 2-10:
Particular requirements for the safety of nerve and muscle stimulators
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
speci ed 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 led, electromagnetic led
(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 modi ed 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 speci ed by the manufacturer. This
may result in increased emission or decreased electromagnetic immunity
and result in improper operation.
Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should by used no closer than 30cm
to any part of the ultrasound system, including cables speci ed by the
manufacturer. Otherwise, degradation of the performance of this equipment
could result.
To maintain basic safety in relation to electromagnetic disturbances during
the expected service life, always use the system in the speci ed
electromagnetic environment and follow the maintenance recommendation
described in this manual.
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