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 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
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 Electronic Nerve Stimulator 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. The Paraphrase of Graphic Symbol
14. Executive Standards
15. Appendix EMC Declaration
Symbol
Explanation
Production Batch
Product catalogue reference code
Manufacturer
(Directive 93/42/EEC amended by Directive 2007/47/EC)
DATE OF MANUFACTURE. This symbol shall be
accompanied by a date to indicate the date of manufacture
Caution
Symbol for CE Mark. This symbol certifies that a product has met
European Union consumer safety, health, or environmental
requirements.
IP22
CE marking with the Registration Number of the Notified Body.
This denotes compliance with European Directive 93/42/EEC
concerning medical devices.
Refer to instruction manual/ booklet
Level of protection against the insertion of solid bodies of size
/diameter ≥ 12 mm and liquids in the presence of dripping water
when tilted at 15° compared with product.
0413
Applied parts: BF type
European Authorized Representative
REF
17
16