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Safety Precautions
USFDA’s definition of the TENS class does not distinguish between the higher and the lower levels of current, voltage, and frequencies (such as muscle-contracting devices). Therefore, the user should be aware that the information listed below is not representative of the products covered but they might apply.
Intended Use:
Avazzia BESTTM devices are USFDA-cleared as Transcutaneous Electrical Stimulation (TENS) for the medical intended use.
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 conditions.
The device is not a replacement for professional health care.
Danger
The device can generate output pulses of 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 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 aetiology is established.
Warnings
- For external use only on normal, intact, clean, healthy skin.
- Keep out of reach of children.
- Do not use over the carotid sinus or carotid sinus nerves, or on the front of the neck or over the thyroid.
- Do not apply stimulation through your chest (transthoracically) or through the head (transcerebrally).
Precautions
Consult with your healthcare provider before using the device if you have heart disease or epilepsy.
Follow your doctor’s instructions when using after an injury or surgical procedure.
Caution should be used in the presence of the following:
- When there is a tendency to haemorrhage 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
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 Manufacturer-approved accessories to avoid injury.
Use caution if you have a tendency to bleed internally, such as following an injury or fracture.
Keep dry. Do not use in or near water.
Warnings
- Safety of electro-stimulation devices for use during pregnancy, birth, or while nursing has not been established.
- 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.
- 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.
- 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.
- 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 a 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.
- 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 Clinician.
- Caution should be used for persons with suspected or diagnosed epilepsy. If you have suspected or diagnosed epilepsy, you should follow the precautions recommended by your Clinician.
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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
- 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 Manufacturer-approved accessories to avoid injury.
- Some persons may experience skin irritation or hypersensitivity from electrical stimulation or electrically conductive medium. The irritation can usually be reduced by using an alternative conductive medium or 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.
- 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 waterproof or water-resistant. Avoid exposure to water or liquid which can result in a possible change in performance.
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.
- Stop using the device and consult with your Clinician if you experience adverse reactions from the device.
- 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.
- Use caution when using on people with low blood pressure, particularly in neck and lower abdomen treatments to avoid light-headedness, dizziness, fainting, and/or falling.