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Prescribing Information

WARNING: FEDERAL LAW RESTRICTS THE SALE OF THIS DEVICE ON THE ORDER OF A LICENSED DOCTOR OR PHYSICIAN, UNDER THE LAWS OF THE STATE WHERE LICENSED TO PRACTICE.

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RS-4i Plus

Indications For Use
Interferential Stimulation (all Pain Relief modes)
■ Relieve acute pain
■ Relieve and manage chronic pain

Muscle Stimulation (all Muscle Therapy modes)
■ Relax muscle spasm
■ Prevention or retardation of disuse atrophy
■ Maintain or increase range of motion
■ Increase local blood circulation
■ Re-educate muscle
■ Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Contraindications
These are the conditions under which this electrical stimulator should not be used:
■ Do not use this device on patients who have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device because this may cause electric shock, burns, electrical interference, or death.
■ Do not use this device whenever pain syndromes are undiagnosed, until etiology (cause) is established.

Warnings
■ Do not apply stimulation over the neck because this type of application could cause severe muscle spasms resulting in closure of the airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure.
■ Do not apply stimulation across the chest, because the introduction of electrical current into the chest may cause rhythm disturbances to the heart, which could be lethal.
■ Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins.) Apply stimulation only to normal, intact, clean, healthy skin.
■ Do not apply stimulation over, or in proximity to, cancerous lesions.
■ Do not apply stimulation in the presence of electronic monitoring equipment (such as ECG monitors and ECG alarms) which may not operate properly when stimulation is in use.
■ Do not apply stimulation when in the bath or shower.
■ Do not apply stimulation while sleeping.
■ Do not apply stimulation while driving, operating machinery, or during any activity in which electrical stimulation can put you at risk of injury.
■ Consult your physician before using this device because the device may cause lethal rhythm disturbances to the heart in susceptible individuals.
■ Electrical nerve stimulation is a symptomatic treatment intended to suppress or lessen the sensation of pain, which would otherwise serve as a protective mechanism.
■ Operation of the device may be affected by shortwave or diathermy therapy, high-frequency surgical equipment, x-rays from computed tomography (CT) scanning, magnetic resonance imaging (MRI), and other ionizing radiation sources.
■ Do not use the device in an environment where flammable gases may be present.
■ Simultaneous connection of a patient to a high frequency surgical device may result in burns at the site of the electrode pads and possible damage to the device.
■ Keep the stimulator and all other items in a cool, dry place, away from liquids, chemicals, cosmetics, direct heat, freezing conditions, and bright sunlight.
■ Do not submerge the device in liquids or expose it to large amounts of water; do not use in the bath or shower.
■ The size, shape, type and electrical performance characteristics of the electrode pads may affect the safety and effectiveness of electrical stimulation.
■ Using electrodes pads that are too small, incorrectly applied or partially adhering to the skin could result in discomfort or skin burns. Electrodes shall be no smaller than 2 inches round or have a surface area 3.14 square inches or smaller.
■ You should contact RS Medical if you do not know if the electrode pads can be used with the stimulation device.
■ Patients should not share electrode pads with other persons because of the risks of adverse skin reactions and disease transmission.
■ Do not modify this equipment without authorization of the manufacturer. Unauthorized modification of any part may result in injury.

Precautions
■ CAUTION: Device can get hot during use. Do not place stimulator directly on skin during treatment.
■ The long-term effects of electrical stimulation are unknown.
■ Since the effects of stimulation of the brain are unknown, stimulation should not be applied across the head, and electrodes should not be placed on opposite sides of the head.
■ The safety of electrical stimulation during pregnancy or birth has not been established.
■ Some patients may experience skin irritation or hyper-sensitivity due to the electrical stimulation or electrical conductive medium.
■ Patients with suspected or diagnosed heart disease should follow precautions recommended by their physician.
■ Patients with suspected or diagnosed epilepsy should follow precautions recommended by their physician.
■ Use caution when there is a tendency to bleed internally, such as following injury or fracture.
■ Use caution following recent surgical procedures when stimulation may disrupt the healing process.
■ Use caution when applying electrical stimulation over a menstruating or pregnant uterus.
■ Use caution if stimulation is applied over areas of skin that lack normal sensation.
■ Keep this device out of the reach of children.
■ Use this device only with the cables, battery, electrode pads, and accessories recommended by RS Medical. Do not substitute or use any other components other than those supplied with the device. Components include: electrode pads, connecting cables, lithium-ion battery, AC adapter, and battery charging dock.
■ Use this device only under the continued supervision of a licensed practitioner.
■ Treatment outcome will be influenced by the patient's psychological state and use of drugs.
■ Stimulation near or over metallic structures or implants may cause discomfort.
■ Interferential stimulation (all Pain Relief modes) has no curative value.
■ Interferential stimulation (all Pain Relief modes) is not effective for pain of central origin (including headache).
■ Do not remove or reposition the electrode pads when the stimulator is on. Touching the conductive gel of the electrodes during treatment may cause an unpleasant transfer of all stimulation directly to your fingertip.
■ Isolated cases of skin irritation may occur at the site of electrode pad placement following long-term application (beyond the prescribed treatment time).
■ Effectiveness is highly dependent upon patient selection by a practitioner qualified in the management of pain patients.
■ Electrode pad placement and stimulation settings should be based on the guidance of the prescribing physician. The device should be used only under the continued supervision of your physician. Contact your prescribing physician if there is any change in an existing condition or if any new condition develops.
■ Do not use if the device appears to be damaged from shipping or the carrying case is opened or damaged; if this occurs, call RS Medical Customer Service at 800-935-7763.

Adverse Effects
■ Patients may experience skin irritation and burns beneath the electrode pads applied to the skin.
■ Patients may experience headache and other painful sensations during or following the application of electrical stimulation near the eyes and to the head and face.
■ Patients should stop using the device and should consult with their physician if they experience adverse reactions from the device.

RS-4m Plus

Indications For Use
Muscle Stimulation (all Muscle Therapy modes)
■ Relax muscle spasm
■ Prevention or retardation of disuse atrophy
■ Maintain or increase range of motion
■ Increase local blood circulation
■ Re-educate muscle
■ Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Contraindications
These are the conditions under which this electrical stimulator should not be used:
■ Do not use this device on patients who have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device because this may cause electric shock, burns, electrical interference, or death.
■ Do not use this device whenever pain syndromes are undiagnosed, until etiology (cause) is established.

Warnings
■ Do not apply stimulation over the neck because this type of application could cause severe muscle spasms resulting in closure of the airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure.
■ Do not apply stimulation across the chest, because the introduction of electrical current into the chest may cause rhythm disturbances to the heart, which could be lethal.
■ Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins.) Apply stimulation only to normal, intact, clean, healthy skin.
■ Do not apply stimulation over, or in proximity to, cancerous lesions.
■ Do not apply stimulation in the presence of electronic monitoring equipment (such as ECG monitors and ECG alarms) which may not operate properly when stimulation is in use.
■ Do not apply stimulation when in the bath or shower.
■ Do not apply stimulation while sleeping.
■ Do not apply stimulation while driving, operating machinery, or during any activity in which electrical stimulation can put you at risk of injury.
■ Consult your physician before using this device because the device may cause lethal rhythm disturbances to the heart in susceptible individuals.
■ Electrical nerve stimulation is a symptomatic treatment intended to suppress or lessen the sensation of pain, which would otherwise serve as a protective mechanism.
■ Operation of the device may be affected by shortwave or diathermy therapy, high frequency surgical equipment, x-rays from computed tomography (CT) scanning, magnetic resonance imaging (MRI), and other ionizing radiation sources.
■ Do not use the device in an environment where flammable gases may be present.
■ Simultaneous connection of a patient to a high frequency surgical device may result in burns at the site of the electrode pads and possible damage to the device.
■ Keep the stimulator and all other items in a cool, dry place, away from liquids, chemicals, cosmetics, direct heat, freezing conditions, and bright sunlight.
■ Do not submerge the device in liquids or expose it to large amounts of water; do not use in the bath or shower.
■ The size, shape, type and electrical performance characteristics of the electrode pads may affect the safety and effectiveness of electrical stimulation.
■ Using electrodes pads that are too small, incorrectly applied or partially adhering to the skin could result in discomfort or skin burns. Electrodes shall be no smaller than 2 inches round or have a surface area 3.14 square inches or smaller.
■ You should contact RS Medical if you do not know if the electrode pads can be used with the stimulation device.
■ Patients should not share electrode pads with other persons because of the risks of adverse skin reactions and disease transmission.
■ Do not modify this equipment without authorization of the manufacturer. Unauthorized modification of any part may result in injury.

Precautions
■ CAUTION: Device can get hot during use. Do not place stimulator directly on skin during treatment.
■ The long-term effects of electrical stimulation are unknown.
■ Since the effects of stimulation of the brain are unknown, stimulation should not be applied across the head, and electrodes should not be placed on opposite sides of the head.
■ The safety of electrical stimulation during pregnancy or birth has not been established.
■ Some patients may experience skin irritation or hyper-sensitivity due to the electrical stimulation or electrical conductive medium.
■ Patients with suspected or diagnosed heart disease should follow precautions recommended by their physician.
■ Patients with suspected or diagnosed epilepsy should follow precautions recommended by their physician.
■ Use caution when there is a tendency to bleed internally, such as following injury or fracture.
■ Use caution following recent surgical procedures when stimulation may disrupt the healing process.
■ Use caution when applying electrical stimulation over a menstruating or pregnant uterus.
■ Use caution if stimulation is applied over areas of skin that lack normal sensation.
■ Keep this device out of the reach of children.
■ Use this device only with the cables, battery, electrode pads, and accessories recommended by RS Medical. Do not substitute or use any other components other than those supplied with the device. Components include: electrode pads, connecting cables, lithium-ion battery, AC adapter, and battery charging dock.
■ Use this device only under the continued supervision of a licensed practitioner.
■ Treatment outcome will be influenced by the patient's psychological state and use of drugs.
■ Stimulation near or over metallic structures or implants may cause discomfort.
■ Do not remove or reposition the electrode pads when the stimulator is on. Touching the conductive gel of the electrodes during treatment may cause an unpleasant transfer of all stimulation directly to your fingertip.
■ Isolated cases of skin irritation may occur at the site of electrode pad placement following long-term application (beyond the prescribed treatment time).
■ Effectiveness is highly dependent upon patient selection by a practitioner qualified in the management of pain patients.
■ Electrode pad placement and stimulation settings should be based on the guidance of the prescribing physician. The device should be used only under the continued supervision of your physician. Contact your prescribing physician if there is any change in an existing condition or if any new condition develops.
■ Do not use if the device appears to be damaged from shipping or the carrying case is opened or damaged; if this occurs, call RS Medical Customer Service at 800 935 7763.

Adverse Effects
■ Patients may experience skin irritation and burns beneath the electrode pads applied to the skin.
■ Patients may experience headache and other painful sensations during or following the application of electrical stimulation near the eyes and to the head and face.
■ Patients should stop using the device and should consult with their physician if they experience adverse reactions from the device.

RS-TENS Plus

Indications
■ Symptomatic relief and management of chronic (long-term) intractable pain.
■ Adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.

Contraindications
■ Do not use the stimulator if you have a demand-type cardiac pacemaker.
■ Do not use the stimulator if you have undiagnosed pain symptoms, until etiology (cause) is established.
■ Do not apply the stimulator over the carotid sinus (neck) region.
■ Do not apply the stimulator in a manner that causes stimulation to flow transcerebrally (through the head).

Warnings
■ The safety of TENS devices during pregnancy or birth has not been established.
■ The safety of TENS devices for patients with cancer is unknown.
■ TENS devices are not effective for pain of central origin (including headache).
■ The stimulator should be used only under the continued supervision of a physician.
■ TENS is a treatment intended to suppress or lessen the sensation of pain, which would otherwise serve as a protective mechanism.
■ Keep the stimulator out of the reach of children.
■ Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when TENS stimulation is in use.
■ Stimulation must not flow through the chest because it may cause a cardiac arrhythmia.

Precautions
■ Isolated cases of skin irritation may occur at the site of pad placement following long-term application.
■ The stimulator may not work for everyone. The effectiveness depends on personal conditions and medical situation.
■ Contact your physician if there is any change in an existing condition or if any new condition develops.
■ Do not use rechargeable batteries if they have been exposed to or immersed in water or liquid as this can damage the RS-TENS Plus.
■ Remove the battery from the RS-TENS Plus during long-term storage to prevent battery leakage. Failure to do so may damage the RS-TENS Plus.
■ The long term effects of electrical stimulation are not known. TENS devices have no curative value.
■ Check battery for signs of corrosion or leaking before use. Replacement batteries can be ordered from RS Medical.
■ Do not attempt to recharge standard alkaline 9-volt batteries in the battery charger. An explosion may result.
■ Dispose of batteries according to current federal, state and local regulations.
■ Store batteries side-by-side so that the metal terminals do not touch. If the terminals touch, the battery could be damaged.

Adverse Effects
■ Possible adverse effects include: skin irritation, allergic reaction, rash, skin damage, localized discomfort, electrical shock and burns under the electrode pads.

Caution
Federal law restricts sale or use of this device on the order of a licensed doctor or physician, under the laws of the state where licensed to practice.

Garments

The RS-LB Low Back Conductive Garment and associated accessories are indicated for use with RS Medical Stimulators to facilitate electrode placement and maintenance of electrode positioning for stimulation treatments of the lower back. Cautiions: Do not connect stimulator cables to the garment without pads in correct place. Each pad must completely cover its metal snap. Do not allow pads to touch each other during stimulation. Do not place or operate this device on the carotid artery region or head. Do not apply to broken skin; if a rash appears, discontinue use and consult your medical professional. Do not use while driving a vehicle or operating machinery. For single patient use only. Keep out of reach of children. Please review the operations manual provided with your stimulator.

Orthosis

Approved for HCPCS Code L0631 – Lumbar-sacral orthosis, sagittal control, with rigid anterior and posterior panels, posterior extends from sacrococcygeal junction to T-9 vertebra, produces intracavitary pressure to reduce load on the intervertebral discs, includes straps, closures, may include padding, shoulder straps, pendulous abdomen design, prefabricated, includes fitting and adjustment. Precaution: not recommended for patients using a pacemaker, patients with a sensitive abdominal condition, such as a distended abdomen due to aortic aneurism, or pregnant women. Keep out of reach of children.