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
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.
13 Executive Standards
Appendix EMC Declaration
Graphic symbol
Paraphrase
Product batch number tag
Product serial number tag
Manufacturer
This product only for indoor use
It means prohibition (the thing was not
permitted to do)
It means enforcement (the thing must be
observed)
Keep out of the sun
Contact its local authorities to determine the
proper method of disposal of potentially bio
hazardous parts and accessories.
Keep away from rain
IP22
CE label and noticed body code
This symbol is used to direct the user to refer to
documentation for additional information
regarding the system use or description.
The dustproofing and waterproofing grade, that
is, to prevent the solid object is greater than
12mm to invade, the inclination of 15 degrees
can prevent dripping invasion still not cause
harmful effects.
0413
Production date
Precautions
EU representative
Warning against danger
Applied part of type BF
Class II equipment
12
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