Use Instructions

ELST026-AUM001-V0.6.2 Page 14 of 68
1.3.3 Conformity with directives
The Acure device series complies with the requirements of the following directives:
 93/42/EEC on medical devices (MDD)
 2006/66/EC on batteries and accumulators (BAD)
 2011/65/EU on the restriction of the use of certain hazardous substances in electrical
and electronic equipment (RoHS2)
 2012/19/EU on waste electrical and electronic equipment (WEEE)
 2014/53/EU on radio equipment (RED)
The device contains no human or animal tissue, no medicinal substances, no blood or blood
products from human or animal origin, no latex, no DHEP, and no radioactive substances.
It is not intended to administer or transport body fluids.
1.3.4 Liability
The manufacturer cannot be held liable for injury to the therapist, the patient or third par-
ties, or for damage to or by the equipment used, if for example:
 an incorrect diagnosis is made
 the user instructions are wrongly interpreted or ignored
 the equipment or the accessories are used incorrectly
 accessories are used other than specified in the instructions for use
 if an external power supply is used other than specified in the instructions for use
 the equipment is badly maintained
 maintenance or repairs are performed by people or organizations that are not author-
ized by GymnaUniphy.
Neither the manufacturer nor the local GymnaUniphy dealer can be held liable, in any way
whatsoever, for the transfer of infections via the needles or any other accessories.