The SaluSTIM® device can affect the operation of demand type cardiac pacemakers. In patients with known myocardial disease, arrhythmias or epilepsy, SaluSTIM® should be used only with consultation and evaluation by a physician. Do not use SaluSTIM® on children under the age of 12 unless under medical supervision.
Safety of SaluSTIM® devices for use during pregnancy or delivery has not been established. Electronic equipment such as EKG monitors and EKG alarms may not operate properly when SaluSTIM® is in use.
The SaluSTIM is for use on the LEFT tragus only.
Turn the unit off before applying or removing electrode. Do not pull lead wires to remove electrodes.
Long-term tVNS stimulation at the electrode site may cause skin irritation. If therapy is experienced unpleasant, discontinue use until re-evaluated by a therapist or physician.
Do not place the SaluSTIM® unit near excessive heat or in water. Keep the SaluSTIM® unit out of the reach of children. Use only Alkaline batteries to ensure a safe and constant current. Remove batteries if the unit is not to be used for a long period of time. Keep the SaluSTIM® unit away from sources of high magnetic fields for example TVs, microwave ovens and hi-fi speakers, as these may affect the LCD screen.
Transcutaneous Vagus Nerve Stimulation (tVNS)
The methodology of VNS used in epilepsy and depression is an invasive procedure. However, there exists an afferent sensory branch of the vagus nerve, which innervates the outer ear canal and parts of the auricle. This Auricular Branch of the Vagus Nerve (ABVN), projects centrally to the nucleus of the solitary tract in the brainstem. It was demonstrated by fMRI and EEG recordings that tVNS of ABVN activates the central vagal pathways similarly as implanted VNS). Therefore, the stimulation of ABVN is a noninvasive method for patients to obtain the beneficial effects of Vagal System Activation.
Safety When using tVNS and Sound Therapy Treatment