EDAN PA Series User Manual page 9

PA Series Biofeedback and Stimulation System User Manual
28 Please do not plug a random USB flash disk into the device, please use a
specialized USB flash disk without virus.
29 Do not apply the device simultaneously with other PATIENT-connected
equipment, such as, a cardiac pacemaker or other electrical stimulators, on the
same patient.
30 Operation in close proximity (e.g.1m) to a shortwave or microwave may
produce instability in the stimulation output.
31 Simultaneous connection of a patient to a high frequency surgical equipment
may result in burns at the site of the stimulator electrodes and cause possible
damage to the stimulator.
32 Application of electrodes near the thorax/heart may increase the risk of cardiac
fibrillation.
33 A patient with an implanted electronic device (for example a cardiac pacemaker)
should not be subjected to stimulation.
34 A hazard could exist if excessive current densities are present.
35 This device is capable of generating current densities exceeding 2mA
r.m.s./cm² that may require special attention of the operator.
36 Use of any equipment in a biofeedback or stimulation context should be
immediately terminated upon any sign of treatment-related distress or
discomfort.
37 The electrodes should not be placed crossing over the heart.
38 The operator is responsible for ensuring the safety of any device controlled or
triggered by the device or software. The software must be configured or device
be connected in such a way to acquire reliable data. Processing or control
functions can trigger patient feedback, but the stimulus shouldn't be too much.
39 Stimulations should not be applied across or through the head, directly on the
eyes, covering the mouth, on the front of the neck, (especially the carotid
sinus).
40 The device should not be applied around swollen, infected inflammation or
tetter, phlebophlogosis, thrombophlebitis.
41 The device should not be applied during pregnancy.
42 Caution should be used for patients with suspected or diagnosed heart
problems.
43 Caution should be used for patients with suspected or diagnosed epilepsy.
44 Some patients may have skin allergy due to electrical stimulation, please
reduce the current intensity or change the location of electrodes.
WARNING
6
Safety Guidance