Use Instructions

ELST026-AUM001-V0.6.2 Page 11 of 68
1.2 Safety instructions
1.2.1 General
 Only qualified people who are trained in the application of the therapy may use the device.
 For optimum treatment, an anamnesis must first be performed. Based on the find-
ings, a treatment plan with objectives will be formulated. Follow the treatment plan
during the therapy. This will limit possible risks, related to the treatment, to a mini-
mum.
 Only treat patients with electrical implants (pacemaker) after obtaining medical advice.
 Only a technician authorized by GymnaUniphy N.V. may open the equipment or the
accessories.
 Always keep these user instructions with the equipment.
 Follow the instructions and directions in these user instructions.
 Only make use of standard and optional accessories listed in these instructions for use.
 When the mains adapter is used then do not place the Acure or other equipment in such a
way the adapter cannot be easily removed from the mains outlet socket.
 Place the equipment on a horizontal and stable surface.
 Keep the ventilation openings at the bottom and rear of the equipment free.
 Do not place the equipment in the sun or above a heat source.
 Do not place any objects on the equipment.
 Do not use the equipment in a damp area.
 Do not let any liquid flow into the equipment.
 Do not sterilize the equipment or accessories.
 For cleaning and disinfecting the equipment and accessories: see § 5.2
 The Medical Devices Directive 93/42/EEG from the European Commission requires devices
to be safe during their service life. Therefore, it is strongly recommended to perform at
least each two years a technical safety inspection. See § 5.1.1
1.2.2 Electrical safety
 Only use the equipment in an area with facilities that meet the applicable legal regulations.
 It is strictly forbidden using any external power supply or battery pack that is not specified
in this user manual. See § 7.6
 Connect the medical grade power supply to an outlet that meets the locally applicable
requirements for medical areas. The device is Class II.
 The output connectors are exclusively for use with the supplied cable of the hand piece and
the 1-pole patient cable.
1.2.3 Prevention of explosion
 Do not use the equipment in an area where combustible gases or vapours are present.
 Switch of the device before disinfecting or decontaminating the room where it is placed.
 Switch off the equipment when it is not used.