Can I use Revitive?

Do not use if:

• 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

Leg symptoms, especially where combined with certain underlying medical conditions, such as high blood pressure, high cholesterol, smoking or diabetes may be an indicator of poor circulation associated with peripheral arterial disease. Consult your doctor as soon as possible if you show any signs of DVT, or have leg symptoms combined with any of the risk factors.

Consult your doctor before using the device if:

• you are under medical treatment
• you have had or are having heart problems
• you are suspected or have been diagnosed with epilepsy
• you are not sure whether Revitive is right for you
• you are not sure where your symptoms come from
• you have an existing medical condition
• you have had medical or physical treatment for your pain
• you have suspected or diagnosed heart disease
• 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 body pads:

• Do not use the electrode pads on the head, face, neck or chest area.
• Do not attach the foot pads and electrode pads directly:
• 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 (such as phlebitis, thrombophlebitis, varicose veins, cellulitis). Check under your feet and toes before using the device
  • on, or close to, malignant tumours
  • on areas treated with radiotherapy (within the past 6 months)
  • on reproductive organs
  • on opposing thighs
• When using TENS do not apply to areas of skin that lack sensation
• Electrode pads are for single person use only. Do not share Body 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 electrodes or hypersensitivity due to the electrical stimulation
• Ensure that any moisturiser/gel/balm is evenly applied and thoroughly absorbed into the skin before applying stimulation. There is a chance that uneven application of a moisturiser/gel/balm 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

When applying foot-pads or electrode body 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/oruse 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

When using TENS:

• It is possible Revitive may reduce the sensation of pain that would normally act as a warning of an underlying problem
• If your pain does not improve, gets worse or continues for more than 5 days, stop using the device and seek advice from your doctor
• TENS is not effective in treating the original source or cause of pain

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
• 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

Revitive Circulation Booster should not be used by some people

Consult with your healthcare professional before use.

Do not use if:
Fitted with an electronic implanted device such as a heart pacemaker or Automatic Implantable Cardioverter Defibrillator (AICD)

• Being treated for, or have symptoms of Deep Vein Thrombosis (DVT): such as pain, swelling and tenderness, heavy ache, warm or red skin in the leg
• You are pregnant
•  

Warnings and cautions

Consult with your doctor before using this device if:

• You have an existing medical condition
• You have a history of heart problems
• 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, 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

If your Osteoarthritis symptoms worsen, or you have had knee surgery (within the last six months), consult with your doctor before reusing Revitive

Do not use the Body Pads on your head, face, neck or chest

Do not apply foot-pads or Body Pads directly

• on open wounds or rashes, swollen, red, infected, or inflamed areas or skin eruptions (such as phlebitis, thrombophlebitis, varicose veins, cellulitis)
• on or close to, malignant tumours
• on areas treated with radiotherapy (within the past 6 months)
• on reproductive organs

Do not apply foot-pads or Thigh (Electrode) Pads directly:

• on open wounds or rashes, swollen, red, infected, or inflamed areas or skin eruptions (such as phlebitis, thrombophlebitis, varicose veins, cellulitis)
• on or close to, malignant tumors
• on areas treated with radiotherapy (within the past 6 months)
• on reproductive organs

Thigh (Electrode) Pads are for single person use only. Do not share Thigh Pads with others

Do not use Thigh (Electrode) Pads in conjunction with a brace or cast without first consulting with your doctor.
Do not use Thigh (Electrode) Pads after their use by date
There is a chance you may experience skin irritation or burns beneath the Thigh (Electrode) Pads or hypersensitivity due to the electrical stimulation
Ensure that balm/gel/moisturiser is evenly applied and thoroughly absorbed into the skin before applying stimulation. There is a chance that the uneven application of a balm/gel/moisturiser 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 yet 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

Cautions

Be careful when applying stimulation:

• over areas of skin that lack normal sensation (eg following injections around the knee). 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
• overstimulation. Check for signs of skin irritation (redness), bruising or pain. If in doubt consult your doctor
• over the abdomen during menstruation
• after recent surgical procedures (within the last six 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 overstimulation or muscle fatigue. Look for signs of skin irritation (redness), bruising or pain. If in doubt, consult your doctor
• The long-term effects of electrical stimulation are unknown
• 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

Safety Precautions

• Do not stand on the machine. Use only when sitting down
• Use the device only for its intended purpose
• Do not expose the device to extreme heat
• Do not spill liquid on the device or its accessories
• Do not overload the electrical socket
• Keep out of the reach of children
• Revitive may be used by multiple persons. Ensure the device is cleaned after each use
• Use Revitive only with the accessories supplied by, or purchased from, the manufacturer
• Check Body Pads, cords and cables periodically for damage
• Do not openRevitive Circulation Booster or repair it yourself. This will invalidate your warranty and may cause serious harm
• In the unlikely event yourRevitive Circulation Booster malfunctions, disconnect it from the power source and contact your nearest authorised agent
• With the increased number of electronic devices such as personal computers and mobile (cellular) telephones, medical devices may be susceptible to electromagnetic interference from other devices. While the REVITIVE Circulation Booster 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 Circulation Booster if used during treatment. If this should occur, simply adjust the time or intensity settings on Revitive back to where you want them to be 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 Circulation Booster and consult with your doctor

Revitive Ultrasound Should Not Be...

• Used for the treatment of malignancy (application over a suspected or confirmed tumour)
• Used on the skin over electronic implants, including pacemakers or defibrillators
• Used on an infected or bleeding area including tuberculosis
• Used on the skin over vascular abnormalities (such as haemangioma, capillary, lymphatic, arterial or arterio-venous malformations)
• Used directly on the abdomen or lower back of pregnant women
• Applied directly over active epiphysis regions (growth plates) in the presence of myositis ossificans (bone formed within the muscle) or over the eyes, skull or reproductive organs
• Used over open wounds or fragile or damaged skin e.g. eczema
• Used on the front of the neck over the carotid sinus
• Used over spinal abnormalities e.g. spina bifida, following laminectomy
• Used over active deep vein thrombosis or thrombophlebitis
• Used on recently radiated tissue (within 6 months)
• Used by individuals who do not comprehend the instructions for application

Revitive Ultrasound Is A Registered Medical Device

Always read the label. Use only as directed. If you are uncertain about the cause of your symptoms or your symptoms persist, please consult your Doctor.

Revitive Aerosure may not be suitable for use by some people

Do not use Revitive Aerosure if you:

• Are pregnant
• Have epilepsy
• Are coughing up blood (active haemoptysis)
• Have acute sinusitis or an active nosebleed
• Have a broken rib until this is completely healed
• Have recently had thoracic (chest) or upper gastro-intestinal tract (duodenum, stomach, oesophagus) surgery or trauma until completely healed
• Currently have or previously had a collapsed lung (Pneumothorax)
• Have abnormally high or low blood pressure, very slow or very fast heart rate (haemodynamic instability) including severe right-sided heart failure with hypotension
• Currently have a blood clot in the blood vessels in the lungs (Pulmonary Embolism)
• Have enlarged veins in the walls of the oesophagus (oesophageal varices)
• Had recent dental, head, neck, ear, nose and throat surgery or trauma until completely healed
• Have abnormally high pressure in the skull and brain (raised intracranial pressure)
• Are experiencing a sudden worsening of breathlessness. For example (but not limited to) exacerbations of asthma

If you are under the care of a health care professional, speak to your health care professional before using Revitive Aerosure.