Use Instructions

ELST026-AUM001-V0.6.2 Page 12 of 68
1.2.4 Electromagnetic compatibility
 Medical electrical equipment requires special precautions for Electro Magnetic Compatibility
(EMC). Follow the instructions for the installation of the equipment. See § 2
 Electromagnetic disturbances may cause instability in the output current causing it to
exceed the specified tolerances. See the EMC guidance in § 8.1.1 for detailed information.
 Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and
the other equipment should be observed to verify that they are operating normally. This
concerns in particular surgical R.F., shortwave, and microwave equipment.
 Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the
Acure device, including the cables. Otherwise, degradation of the performance of this
equipment could result.
 Use of accessories and cables other than those specified or provided by GymnaUniphy,
see § 7.6, could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
1.2.5 Therapy application

Simultaneous connection of a patient to a high frequency surgical equipment may result in
burns at the site of the stimulator electrodes and possible damage to the Acure device.
 Application of electrodes near the thorax may increase the risk of cardiac fibrillation.
 It is strictly recommended only to do needling on one body half in one treatment
 Needle puncture in hemiplegic patients on the affected side also is strictly advised against
 It is advised not to exceed the current density of 0.25 mA/cm
²
for galvanic currents.
Higher intensities may cause skin irritation or skin burns, specific under the anode
electrode.
 Use the large size rectangular silicone rubber electrode as anode (positive electrode)
with a well-moistened sponge making direct contact to the skin surface.
 Do not use a self-adhesive electrode as the positive electrode because skin burns are
highly likely to occur, independent of the electrode size.
 Use only disposable sterile acupuncture needles with the correct properties. See §7.3
 Immediately remove and dispose the acupuncture needle after use in a safe way. Place
the hand piece always in the holder when it is not used.
 Check the hand piece, electrode cables and the electrodes at least once a month.
Check whether the insulation is still intact.
 Replace the hand piece if the cable or the connector are damaged. See § 5
 Check the conductivity of the silicone rubber electrode at least once a week. See § 4.7.1