7Wearable Life Science GmbH6. CONTRAINDICATIONSPowered muscle stimulators should not be used on patients with cardiacdemand pacemakers.1. The long-term effects of chronic electrical stimulation are unknown.2. Stimulation should not be applied over the neck or mouth. Severespasm of the laryngeal and pharyngeal muscles may occur and thecontractions may be strong enough to close the airway or cause dif-ficulty in breathing.3. Stimulation should not be applied across the chest in that the in-troduction of electrical current into the heart may cause cardiac ar-rhythmias.4. Stimulation should not be applied to the head.5. Stimulation should not be applied over swollen, infected, or in-flamed areas or on skin eruptions.6. Stimulation should not be applied over, or in proximity to, cancer-ous lesions.PRECAUTIONS:1. Safety of powered muscle stimulators for use during pregnancy hasnot been established.2. Caution should be used for users with suspected or diagnosed heartproblems.3. Caution should be used for users with suspected or diagnosed epi-lepsy.4. Caution should be used in the presence of the following:a. When there is a tendency to bleed because of injury;b. Following recent surgical procedures when muscle contrac-tion may disrupt the healing process;c. Over the menstruating or pregnant uterus; andd. Over areas of the skin which lack normal sensation.5. Some patients may experience skin irritation or hypersensitivity dueto the electrical stimulation or the electrodes.6. Electrode placement and stimulation settings should be followed inaccordance with this manual.7. Powered muscle stimulators should be kept out of the reach of chil-dren.8. Powered muscle stimulators should be used only with the leads andelectrodes recommended for use by the manufacturer.9. Powered muscle stimulators should not be used while driving, oper-ating machinery, or during any activity in which involuntary musclecontractions may put the user at undue risk of injury.ADVERSE REACTIONSSkin irritation and burns beneath the electrodes have been reported withthe use of powered muscle stimulators.The following points may indicate serious damage to the muscle tissue(rhabdomyolysis). If you find yourself displaying one of these symptomsplease contact a physician:• Brown urine• Myalgia (severe muscular pain)• Extreme swelling of the muscle