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Contraindications

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Electrodes should NEVER be placed on or near the stellate ganglion and/or the heart itself. Thoracic applications are contraindicated.

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  • ·         Thrombosis: It is possible the current could produce chemical changes in the blood leading to alteration in the clotting time. At present there is no hard evidence to support this. However, any individual taking anticoagulants should consult with their primary care physician before using VT-200 treatments.

  • ·         Pacemaker/Defibrillator: 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.

  • ·         Undiagnosed Conditions:  Do not use this device on patients whose pain syndromes are undiagnosed.

  • ·         Cardiac Conditions: If someone has known or potential cardiac problems, they should consult with their primary caregiver or cardiologist before using the VT-200

  • ·         Bacterial Infections: The effect on bacteria is uncertain, so if your skin has a bacterial infection, avoid running the treatment on or near the area of infection.

  • ·         Malignancy: The use of electrotherapy treatments is contraindicated in individuals with clinically diagnosed cancer and should never be run directly over the site of a known malignancy. 

Warnings

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VT-200 treatments should NEVER cause discomfort or pain. Should the user experience discomfort during treatment; use a lower intensity setting for the treatment. If the user continues to experience discomfort, discontinue the treatments and notify your physician or Alan Neurmedical Technologies

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  • ·       Epilepsy: Patients with suspected or diagnosed epilepsy should follow precautions recommended by their physicians.

  • ·       Neck and Mouth Placement: Do not apply stimulation over the patient’s neck because this could cause severe muscle spasm resulting in closure of the airway, difficulty in breathing or adverse effects on heart rhythm or blood pressure.

  • ·       Consult a Physician:Consult with the patient’s physician before using this device, because the device may cause lethal rhythm disturbances to the heart in susceptible individuals.

  • ·       Skin: Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed area or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins).

  • ·       Electronic Monitoring Equipment:Do not apply stimulation in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly when the electrical stimulation device is in use.

  • ·       Chest Placement:Do not apply stimulation across the patient’s chest, because the introduction of electrical current into the chest may cause rhythm disturbances to the patient’s heart, which could be lethal.

  • ·       Electrode Placement:Never apply electrodes near the heart, head, neck or eye.

  • ·       Children: This device should be kept out of the reach of children

  • ·       Long Term Effects:The long-term effects of electrical stimulation are unknown.

  • ·       Battery Replacement:The internal battery will most likely not need to be changed. The internal battery should not be changed by the operator. If there are questions, contact Alan Neuromedical Technologies.

  • ·       Surgical Equipment Warning: Burns at the site of the electrodes and possible device damage may result from simultaneous connection of a patient to high frequency surgical equipment and the VT-200 at the same time.

  • ·       Specific Conditions:This device should not be used in the following conditions:

    • Pregnancy

    •  Acute and sub-acute thrombophlebitis

    •  Over or near potentially malignant lesions

    •  Implants of any electrical nature. Patients with implanted nerve stimulators should only be treated after full evaluation by their physician

    •  Over a carotid sinus

    •  In the presence of a disturbance in cardiac rhythm unless cleared by cardiologist

  • ·       Stimulation Use:Do not apply stimulation during the following conditions:

    • When the patient/user is in the bath or shower

    • When the patient/user is sleeping

    • While the patient is driving, operating machinery, or during any activity in which electrical stimulation can put the patient at risk of injury

Precautions

  • ·       Post Surgery: Precautions should be observed following recent surgical procedures when muscle contractions may disrupt the healing process.

  • ·       Use caution when there is a tendency to hemorrhage following acute trauma or fracture, or over the pregnant or menstruating uterus. However, there are no protocols that direct a patient to put electrodes on the abdomen.

  • ·       Application of Heat: NEVER apply any source of heat (such as a heating pad) to an area being treated. Skin irritation and burns beneath the electrodes have been reported with the use of electrical stimulation and TENS devices.

  • ·       Sensitive Skin and Nerve Damage: Use extreme caution when administering a treatment where sensory nerve damage is present or in any case where there is a loss of normal skin sensation, including areas desensitized by medication.

  • ·       Skin Irritation: Some patients may experience skin irritation or hypersensitivity from the electrodes. Apply stimulation only to normal, intact, clean, healthy skin.

  • ·       Adverse Reactions: Some 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.

  • ·       Heart Disease: Patients with suspected or diagnosed heart disease should follow precautions recommended by their physicians.

  • ·       Advisory:Use of TENS devices, such as the VT-200

    • Is not effective for pain of central origin, including headache;

    • Is not a substitute for pain medications and other pain management therapies;

    • Is only recommended while under the continued supervision of a licensed practitioner;

    • Use only with the leads, electrodes and accessories recommended by the manufacturer;

    • Have no curative value

    • Is a symptomatic treatment and, as such, suppresses the sensation of pain that would otherwise serve as a protective mechanism;

    • Effectiveness is highly depending upon patient selection by a practitioner qualified in the management of pain patients:

    • 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 has not been established.

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NOTE: The law of the United States and other countries restricts the sale of this device to physicians, physical therapists, chiropractors, dentists or other practitioners licensed by the law of the state in which said person practices, or to individuals who have received a legal prescription from their medical practitioner for the use of this device. 

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 The VECTTOR Therapy System is indicated in the United States for the treatment of chronic, intractable pain and for the treatment of post-surgical trauma pain.    Any other use of the VECTTOR Therapy System would be considered off-label use.

DrRhodes@VECTTOR.com

Caution: There are contraindications, warnings, precautions, and guidelines that should be reviewed with your physician prior to using the VECTTOR Therapy System. MKT-003 Rev E ECN 23-004

 

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