Products

SurgiStim4^™

Indications

The High Volt Pulsed Current Stimulation and Neuromuscular Electrical Stimulation can be used in the following applications:

Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increases local blood circulation
Muscle re-education
Maintaining and increasing range of motion
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Relieves acute pain
Relieves chronic pain
Relaxation of muscle spasms
Maintaining and increasing range of motion
Increases local blood circulation
Reduction of edema (under negative electrode)
Relaxation of muscle spasm
Increasing local blood circulation
Retardation or prevention of disuse atrophy
Muscle re-education
Maintaining or increasing of range of motion

Contraindications

Stimulators should not be used on patients with cardiac demand pacemakers.

Warnings

The long-term effects of chronic electrical stimulation are unknown.
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 over the neck or mouth; severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing.
Electrodes should not be placed on the chest in such a configuration that would allow electrical current delivered by the device to flow through the chest because it might cause a cardiac arrhythmia.
Stimulation should not be applied transcerebrally.
Stimulation should not be applied over swollen, infected, or inflamed areas or skin eruptions, e.g. phlebitis, thrombophlebitis, varicose veins, etc.
Stimulation should not be applied over, or in proximity to, cancerous lesions.
Due to the potential for causing skin burns, this device should only be used with electrodes which limit the current density to 0.25W/cm2
Stimulation should not be applied transthorasically in that the introduction of electrical current may cause cardiac arrhythmias.

Precautions

Safety of stimulators for use during pregnancy has not been established.
Caution should be used for patients with suspected or diagnosed heart problems.
Caution should be used for patients with suspected or diagnosed epilepsy.
Caution should be used in the presence of the following:
- When there is a tendency to hemorrhage following acute trauma or fracture;
- Following recent surgical procedures when muscle contraction may disrupt the healing process;
- Over the menstruating or pregnant uterus; and
- Over areas of the skin which lack normal sensation
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 alternative conductive medium or alternate electrode placement.
Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner.
Keep out of reach of children.
Use only with the leads and electrodes recommended for use by the manufacturer.
Portable stimulators should not be used while driving, operating machinery, or during any activity in which involuntary muscle contractions may put the user at undue risk of injury.
When the amplitude in the IF mode exceeds 40mA, electrical noise from the device could interfere with other equipment operating in the nearby area.
Do not trim electrodes as cut edges can affect even distribution of stimulation.
Do not immerse electrodes in water.

Adverse Reactions

Skin irritation and burns beneath the electrodes have occasionally been reported with the use of electrical stimulators. If you experience any symptoms of skin irritation or any unusual reactions while using the SurgiStim4, discontinue use immediately and contact VQ OrthoCare’s Patient Care Department at 800.452.7993 or consult your physician.

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.

SurgiStim4