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Revitive should not be used by some people.
Do not use if (contraindications)
- You are fitted with an electronic implanted device such as a heart pacemaker or Automatic Implantable Cardioverter Defibrillator (AICD)
- You are pregnant
- You are being treated for, or have the symptoms of, an existing Deep Vein Thrombosis (“DVT”)
Long periods of inactivity can put you at greater risk of developing Deep Vein Thrombosis (DVT). DVT is a blood clot and usually occurs in a deep leg vein. If part of the DVT breaks off it may lead to potentially life- threatening complications such as pulmonary embolism.
If you have been inactive for prolonged periods and suspect you may have a DVT, consult your doctor immediately. To prevent dislodging the clot do not use Revitive.
In some cases of DVT there may be no symptoms. However it is important to be aware of the symptoms that may include:
- Pain, swelling and tenderness in one of your legs (usually your calf)
- A heavy ache in the affected area
- Warm skin in the area of the clot
- Redness of your skin, particularly at the back of your leg, below the knee
Consult your doctor as soon as possible if you show any signs of the above symptoms.
Warnings
Consult with your doctor before using this device if:
- You are in the care of a doctor
- You have a history of heart problems
- You have had medical or physical treatment for your pain
- You have suspected or diagnosed heart disease
- You have suspected or diagnosed epilepsy
- You are unsure about the suitability of Revitive for you
- You are unsure about the cause of your symptoms
If you have a metallic implant:
- If you have a metallic implant, you may experience pain or discomfort near the implant when applying electrical stimulation. If this should occur discontinue use and seek advice from your doctor
- The electrical stimulation may feel more intense close to a metallic implant. It is safe to continue use provided no pain is experienced. You may need to adjust the intensity to a comfortable level
When applying foot-pads or electrode pads:
- Do not use the electrode pads on your head, face, neck or chest
- Application of the electrodes near the thorax (chest) may increase the risk of cardiac fibrillation
- Only apply to areas with intact/unbroken skin
- Do not apply foot-pads or electrode pads directly or adjacent to these areas:
- on cut or broken skin; open wounds or rashes; swollen, red, infected or inflamed areas; or skin eruptions (eg phlebitis, thrombophlebitis, varicose veins, cellulitis). Check under your feet and toes before using the device
- over, or in proximity to (close to), cancerous lesions/malignant tumours•on areas treated with radiotherapy (within the past 6 months)
- on reproductive organs
- over the carotid sinus nerves (front of the neck), particularly in patients with a known sensitivity to the carotid sinus reflex
- on opposing thighs and refer to pad placement diagrams in this User’s Manual for correct placement
- Electrode pads are for single person use only. Do not share electrode pads with others
- Do not use electrode pads after their use-by date
- There is a chance you may experience skin irritation or burns beneath the electrode pads or hypersensitivity due to the electrical stimulation
- Ensure that any water based moisturiser is evenly applied and thoroughly absorbed into the skin before applying stimulation. There is a chance that uneven application could increase the risk of skin irritation or burn, when using the electrical stimulation
- Symptoms may worsen during the initial treatment phase before getting better. This may occur if the body has not fully adjusted to increased muscular activity and blood circulation. If this occurs, reduce the intensity and the duration of treatment which will reduce the initial symptoms. If symptoms persist consult with your doctor
When not to use Revitive:
- There are times you should not use Revitive. Do not use Revitive:
- In the presence of electronic monitoring equipment
- Together with a life-supporting medical electronic device
- When you are in the bath or shower
- While you are sleeping
- In conjunction with a brace or cast without first consulting with your doctor.
- Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally
Additional Warnings:
- Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation
- Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Revitive System, including cables specified by the manufacturer
Cautions
When applying stimulation:
When applying foot-pads or electrode pads:
- Be careful when applying stimulation over areas of skin that lack normal sensation. It may cause skin irritation due to the inability to feel stimulation until the intensity is too high. Use a low intensity to achieve a gentle muscle contraction, and/or use for a shorter time, to avoid over-stimulation. Check for signs of skin irritation (redness), bruising or pain. If in doubt consult your doctor
- This product is not intended for use by persons with reduced physical, sensory or mental capabilities, unless they are supervised by a person responsible for their safety
When using EMS:
- Be careful when applying stimulation:
- Over the abdomen during menstruation
- After recent surgical procedures (within the past 6 months) as stimulation may disrupt your healing process
- If your tissues are likely to bleed following an injury such as a muscle tear - it is recommended not to stimulate the immediate area within the first 12 hours after sustaining the injury. Use a low intensity and/or shorter time to avoid over-stimulation
- After a long period of immobility or inactivity – use a low intensity and shorter time to avoid over- stimulation or muscle fatigue
Additional Cautions:
- The long term effects of electrical stimulation are unknown
- Electrical stimulation may not work for every user, please seek advice from your doctor
Safety Precautions
- Do not stand on the machine. Use only when seated
- Do not position Revitive so that it is difficult to disconnect or turn off
- Use Revitive only for its intended purpose
- Do not expose Revitive to extreme heat
- Do not spill liquid on Revitive or its accessories
- Do not overload the electrical socket
- Keep device out of the reach of children
- Keep power cords and cables out of the reach of children to prevent risk of strangulation
- Revitive foot-pads may be used by multiple persons. Ensure device is cleaned after each use
- During use, do not touch foot-pads with your hands until Revitive has powered off
- Use Revitive only with the accessories supplied by, or purchased from, the manufacturer
- Check electrode cables periodically for damage
- Do not open Revitive or repair it yourself. This will invalidate your warranty and may cause serious harm
- In the unlikely event your Revitive malfunctions, disconnect it from the power source and contact your nearest authorised agent
- Revitive has passed the required tests for Electromagnetic Interference (EMI); it may still be affected by excessive emissions and/or may interfere with more sensitive equipment
- It has been reported that some universal remote control devices (e.g. for TV etc.) can change the settings on Revitive if used during a treatment. If this should occur, simply adjust the time or intensity settings on Revitive back to where you want them using the Revitive Remote Control, or using the device Control Panel
- After any exposure to hot or cold temperatures outside the specified operating range of 10 – 40°C allow the product to re-adjust to the recommended operating temperatures to ensure continued product performance
Adverse Reactions
If you experience adverse reactions, stop using Revitive and consult with your doctor immediately