Prescribing Information

Caution: Federal law USA) restricts this device to sale by or on the order of a physician. Keep out of the reach of children.

Indications: Transcutaneous Electronic Nerve Stimulation (TENS) Devices are used for the symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.

Contraindictions: TENS devices can affect the operation of demand type cardiac pacemakers. In patients with known myocardial disease or arrhythmias, TENS should be used only with consultation and evaluation by a physi- cian. Do not use TENS on the eyelids. Do not place electrodes directly over the carotid sinus nerves or arteries, and laryngeal or pharyngeal muscles. Do not apply TENS for undiagnosed pain syndromes until etiology is established. Any electrode placement that causes current to flow transcerebrally (through the head) is not allowed.

Warnings: This device should be used only under the continued supervision of a physician. TENS is ineffective for pain of central origin. TENS is of no curative value; it is a symptomatic treatment which suppresses pain sensation which would otherwise serve as a protective mechanism on the outcome of the clinical process. Safety of TENS devices for use during pregnancy or delivery has not been established. For external use only. Electronic equipment such as EKG monitors and EKG alarms may not operate properly when TENS is in use.

Precautions: Avoid adjusting controls while operating machinery or vehicles. Turn the stimulator off before ap- plying or removing electrodes. Long term stimulation at the same electrode site may cause skin irritation. If TENS therapy becomes ineffective or unpleasant, stimulation should be discontinued until its use is reevaluated by the physician or therapist. Use only for the specific pain problem prescribed by a physician.

Effectiveness is dependent upon patient selection.

Adverse Reactions: Possible allergic reaction to tape or gel. Possible skin irritation or electrode burn under elec- trode. If skin irritation persists, discontinue use and consult a physician.