Important Safeguards Important Safeguards

Contraindications

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

 

Warnings & Cautions

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 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

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