Can I use Revitive?

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

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 with your doctor before using this device if:

  • You have an existing medical condition
  • 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 body 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
  • Do not apply foot-pads or electrode pads directly on these areas:
    • 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
    • on opposing thighs and refer to pad placement diagrams in this User’s Manual for correct placement 
  • When using TENS do not apply to areas of skin that lack sensation.
  • 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

When applying foot-pads or electrode body pads:

  • 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 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

EMS only

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.

 

TENS only

When using TENS do not apply to areas of skin that lack sensation

When applying stimulation:

  • 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

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 Revitive and seek advice from your doctor
  • TENS is not effective in treating the original source or cause of pain

Additional Cautions:

  • 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
  • The long term effects of electrical stimulation are unknown
  • Electrical stimulation may not work for every user, please seek advice from your doctor
  • 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 the paused feature is enabled or device has powered off
  • Use Revitive only with the accessories supplied by, or purchased from, the manufacturer 
  • Check electrode pads, cords and 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
  • 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
  • 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
  • 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.

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

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

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
  • 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 (blood vessel) 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 eg 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 irradiated tissue (within 6 months)
  • Used on heart, eye, testes, near brain, cervical ganglia, spine, laminectomy sites (can cause spinal cord bleeding)
  • Used by individuals who do not comprehend the instructions for application

If you have any doubts about the suitability of Revitive Ultrasound, please consult your healthcare professional before using this product

  • Clean the Treatment Head completely after use as this will prevent any possible cross-infection to other users.
  • People with local circulatory insufficiency or bleeding disorder (eg haemophilia) should consult their health care professional before use.
  • Do not use on de-sensitised (numb, hypoaesthesia) areas of the skin (eg diabetic neuropathy).
  • Use caution when treating pain of undiagnosed origin with a history of cancer (within 5 years).
  • Use a low intensity setting only over areas containing plastic/ cement implants.
  • If you have a metallic implant, you may experience pain or discomfort near the implant when applying ultrasound stimulation. If this should occur discontinue use and seek advice from your doctor
  • The ultrasound 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 power to a comfortable level
  • Discontinue use if any signs of inflammation increase (redness, heat, pain, swelling).
  • Discontinue use if ‘pins and needles’ are experienced during treatment and consult your health care professional.
  • The socket outlet should be installed near the equipment and should be easily accessible.
  • Use only the accessories supplied by, or purchased from, the manufacturer.
  • Do not modify this equipment without authorisation of the manufacturer.
  • Do not service and maintain the device while it is in use.
  • The patient may be the intended operator.
  • The device must only be serviced, repaired and opened by service staff (authorised dealers).

     

  • Do not use the device if it is damaged. The continuous use of a damaged device may cause injury, improper results, or serious danger.
  • Do not store the device at an extreme temperature (below -10°C or over 50°C) or humidity extremes (below 20%RH or over 93%RH). Doing so may affect the performance of the device.
  • Store the device in the dry, clean place. Keep the device away from pets and pests.
  • Do not expose the product to any chemical solvent, water, lint, dust, direct sun or high temperature.
  • Keep power cords and cables out of the reach of children to prevent risk of strangulation.
  • Keep the device out of the reach of children to avoid inhalation or swallowing of small parts.
  • Do not operate the device when connected to any other medical device.
  • 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.
  • 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.
  • 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 device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • When the operating environment is relatively dry, strong electromagnetic interference usually occurs. At this time, the device may be affected as follows:
    •  the device stops output;
    • the device turns off;
    • the device restarts;
  • The above phenomenon does not affect the basic safety and essential performance of the device, and the user can use it according to the instructions. If you want to avoid the above phenomenon, please use it according to the environment specified in the manual.
  • Ultrasound should be routinely checked before each use to determine that all controls function normally, especially that the intensity control properly adjusts the intensity of the ultrasound power output in stable manner. Also, determine that the treatment time control does actually terminate ultrasound power output when the timer reaches zero.
  • Before each use, inspect the Treatment Head for cracks, which may allow the ingress of conductive fluid.
  • You may experience skin irritation due to the gel. Discontinue use if any signs of allergy occur.
  • Use the Treatment Head with care. Inappropriate handling of the Treatment Head may adversely affect its characteristics.
  • 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 gastrointestinal 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 (Current Pulmonary embolism)
  • Have enlarged veins in the oesophagus (Oesophageal varices)
  • Had recent dental, head, neck, ear, nose & 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.
  • It is not advised to use this device in the case of users with neurological disorders, respiratory disease in end-stage (incl. COPD and Cystic Fibrosis) unless under medical supervision.
  • Use of this device does not replace the requirement for any prescribed medication. Do not stop taking your medication or change the dosage without first consulting your doctor
  • For hygiene reasons, this product is intended for a single user only. Do NOT share the Valve Head or mouthpiece with any other users.
  • If you feel light headed, dizzy or pain whilst using Revitive Aerosure, stop using it immediately and rest. If these symptoms persist, consult your doctor.
  • In the Mucus Relief mode the mucus is dislodged from the airways and lungs - you must then clear this mucus through effective coughing. In the presence of an ineffective cough, additional assisted coughing devices or techniques may be required and advice sought from a qualified medical practitioner.
  • Use this product only for its intended use as described in this manual.
  • Swallowing air should be avoided as this may lead to an increased likelihood of vomiting and aspiration If you experience a sore or dry throat, stop using the device until these symptoms go away or try drinking some water. If symptoms persist, consult your doctor.
  • Do not use attachments which are not recommended by the manufacturer.
  • This product is not intended for use by children or persons with reduced physical, sensory or mental capabilities, unless they are supervised by a person responsible for their safety.
  • Keep the product out of the reach of children.
  • Clean the Valve Head and mouthpiece prior to first use
  • Always unplug before cleaning.
  • Do not submerge the handle or charger in water or other liquid.
  • Do not place or store the charger where it can fall or be pulled into water or other liquids.
  • Do not reach for a charger that has fallen into water or other liquids. Unplug immediately.
  • Do not touch the power plug with wet hands. This can cause an electric shock.
  • Do not use if the adaptor or cord is damaged. If the cord is damaged, contact your local distributor. The power cord is not intended for repair by service personnel. If damaged the whole charger unit will require replacement.
  • Do not modify, repair or disassemble any part of the product. This may cause fire, electric shock or fatal injury. Consult your dealer or contact your local distributor for information and assistance.
  • Do not insert any object into the Valve Head or into any opening of the device or charger.
  • Ensure no particles or objects are lodged in the valve head and obstructing airflow.

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