Products

Biotens™

Indications

Symptomatic relief of chronic intractable pain
Management of post-traumatic and postsurgical pain

Contraindications

Should not be used on patients with cardiac demand pacemakers.
Stimulation should not be applied over the carotid sinus nerves, particularly in patients with a known sensitivity to the carotid sinus reflex.
Stimulation should not be applied transcerebrally.
TENS unit should not be used on undiagnosed pain syndromes until etiology is established.

Warnings

TENS devices should be used only under the continued supervision of a physician.
Safety for use during pregnancy or birth has not been established.
TENS is not effective for pain of central origin (this includes headache).
TENS devices have no curative value.
TENS is a symptomatic treatment and as such suppresses the sensation of pain which would otherwise serve as a protective mechanism.
Keep out of reach of children.
Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when TENS stimulation is in use.

Precautions

Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium. The irritation can usually be reduced by using an alternate conductive medium or alternate electrode placement.
Effectiveness is highly dependent upon patient selection by a person qualified in the management of pain patients.

Adverse Reactions

Skin irritation and burns beneath the electrodes have occasionally been reported with the use of stimulators.

CAUTION: Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices to use or order the use of the device.

Stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

Biotens