Safety Precautions

INTENDED USE:

Avazzia BEST devices are FDA-cleared as TENS for

  • Prescription use for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment in the management of post-surgical and post-traumatic pain.
  • Over-the-counter use for the temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

 

Read all instructions, warnings and precautions as well as the Owner’s Manual before using the device. It should be used only for the purpose for which it is intended. Devices are not intended for diagnosis or treatment of disease condition.

The device is not a replacement for professional health care.

DANGER

The device can generate output pulses up to 650 Volts. To avoid skin irritations such as burns, do not use device for prolonged periods of time in a single location, while sleeping or other unattended use.

Misuse could result in fire hazard.

Contra-indications

Do not use on persons with a demand-type cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death.

Do not use if pregnant or nursing. Use caution if stimulation is applied over the menstruating or pregnant uterus.

Do not use device for undiagnosed pain syndromes until etiology is established.

Warnings

  • If you are in the care of a physician, consult with your physician before using this device. If you have had medical or physical treatment for your pain, consult with your physician before using this device. If your pain does not improve, becomes more than mild, or continues for more than five days, stop using the device and consult with your physician. Device should only be used under the continued supervision of a physician or under the supervision of a qualified medical practitioner to whom the patient is referred by a physician.
  • Safety of electro-stimulation devices for use during pregnancy, birth or while nursing has not been established.
  • TENS device is not effective for pain of central origin such as headaches.
  • Stimulation should not be applied over the carotid sinus nerves, particularly in patients with a known sensitivity to the carotid sinus reflex.
  • Stimulus delivered by this device may be sufficient to cause electrocution. Electrical current of this magnitude must not flow through the thorax because it may cause cardiac arrhythmia. Do not use near the thorax to avoid the risk of cardiac fibrillation.
  • Do not apply stimulation across your chest because the introduction of electrical current into the chest may cause rhythm disturbances to your heart, which could be lethal.
  • Consult with your physician before using this device, because the device may cause lethal rhythm disturbances to the heart in susceptible individuals.
  • Stimulation should not be applied over the front of 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.
  • Do not apply stimulation over your thyroid or the carotid sinus because this could cause severe muscle spasms resulting in closure of your airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure.
  • Do not allow any electrode placement that applies current flow transcerebrally (through the head). Since the effects of stimulation of the brain are unknown, stimulation should not be applied across your head, and electrodes should not be placed on opposite sides of your head.
  • Stimulation should not be applied over open wounds or rashes, swollen, red, infected, or inflamed areas or skin eruptions such as phlebitis, thrombophlebitis, varicose veins, etc. Stimulation should not be applied over, or in proximity to, cancerous lesions.
  • Device is a symptomatic treatment and as such may suppress the sensation of pain which would otherwise serve as a protective mechanism.
  • Keep device out of reach of children. It is not a toy. It should not be used as a weapon. Do not use the device on children, if it has not been evaluated for pediatric use. Strangulation may result from baby or child becoming entangle in monitoring cables or lead wires. Choking may occur from swallowing or attempting to swallow batteries.
  • Electronic monitoring equipment, such as ECG monitors and ECG alarms, may not operate properly when device stimulation is in use. Electro-pulses may interfere with pacemakers and/or other electronic and radiological equipment.
  • Do not apply stimulation while sleeping.
  • Do not use in or near water. Do not apply stimulation when in the bath or shower.
  • Apply stimulation only to normal, intact, clean, healthy skin.

Precautions

  • Device is not a substitute for pain medications and other pain management therapies. Patient should consult clinician if there is any change in existing condition or if any new condition develops. Devices have no curative value. Device is for symptomatic therapy only. Device should not be given to other individuals. Stimulator should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. Use only as directed.
  • Effectiveness is highly dependent upon subject selection by a qualified healthcare professional.
  • Do not use the device on persons who may be under the influence of alcohol or other drugs. Do not use on the eyeball.
  • Caution should be used for persons with suspected or diagnosed heart problems. If you have suspected or diagnosed heart disease, you should follow precautions recommended by your physician.
  • Caution should be used for persons with suspected or diagnosed epilepsy. If you have suspected or diagnosed epilepsy, you should follow precautions recommended by your physician.
  • 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
    • Over areas of the skin which lack normal sensation
    • Skin irritation
  • Use caution if you have a tendency to bleed internally, such as following an injury or fracture.
  • Do not use while operating machinery or vehicles or during any activity in which electrical stimulation can put you at risk of injury.
  • Use device only with treatment plates (built-in electrodes) or with accessories recommended for use by the manufacturer to avoid injury.
  • Some persons may experience skin irritation or hypersensitivity from electrical stimulation or electrical conductive medium. The irritation can usually be reduced by using an alternate conductive medium, or alternative electrode placement.
  • Simultaneous connection of patient to high frequency surgical equipment may result in burns at the site of the stimulator electrodes and possible damage to the stimulator.
  • Results of use may be influenced by a person’s psychological state and use of drugs.
  • NOTICE – DO NOT USE FOR RESUSITATION
  • Device is not a life-saving device.
  • Long-term effects of chronic electrical stimulation are unknown.
  • WARNING: No modification of this equipment is allowed. Modification voids warranty. Do not modify the device or accessories to avoid breaking the device or changing its performance. Do not operate if unit has been dropped. Do not operate if case is damaged. Do not operate if unit does not function properly. It can be unsafe to modify equipment or to use modified equipment.
  • Do not place near heat from a fireplace or radiant heater to avoid melting device and damage to the case or nameplate and control keys. Keep away from moisture from a nebulizer or steam kettle to avoid moisture from getting inside the device which may result in electrical shorts or corrosion.
  • Keep dry. Do not use in or near water. The device is not water proof or water resistant. Avoid exposure to water or liquid which can result in possible change in performance.
  • Operation in close proximity (e.g. 1m) to shortwave or microwave therapy equipment may produce instability in the stimulator output.
  • Current density for any electrode exceeding 2 mA r.m.s./cm² may require a special attention of the operator.

Stimulation should not be applied directly over or in proximity to metallic implants in the spine without first consulting with your physician

Adverse Reactions

  • Skin irritation and electrode burns beneath the electrodes have been reported with TENS use. Patients may experience skin irritation and burns beneath the stimulation electrodes applied to the skin. To reduce risk of skin burns, keep treatment plates (built-in electrodes) directly against skin during application. Improper use may result in electrode burns.
  • Headache and other painful sensations during or following the application of electrical stimulation near eyes and to head and face; have been reported with TENS use.
  • Stop using the device and consult with your physician if you experience adverse reactions from the device.
  • Use caution when using on people with low blood pressure, particularly in neck and lower abdomen treatments to avoid lightheadedness, dizziness, fainting, and/or falling.

MKT-180401-46 A

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