Precautions

Contraindications

Contraindications for the use of sam® Sport include over an area of the body where a malignancy is known to be present, over the eyes, over or near growth centers until bone growth is complete, over the reproductive organs, over the pregnant uterus, over a healing bone fracture, on the thoracic area if the patient is using a cardiac pacemaker, over an active implanted medical device such as an implanted deep brain stimulation device, on the brain, spinal cord, or large subcutaneous peripheral nerves, ischemic tissues in individuals with vascular disease where the blood supply would be unable to follow the increase in metabolic demand and tissue necrosis might result.  

Warnings

  • If the treatment is reported as painful or too hot at any point during treatment, turn off device and remove the device from the skin.
  • Instruct the patient to inform the practitioner if the patient feels any pain or burning during treatment.
  • Instruct the patient how to turn off the sam® Sport device and remove the sam® Sport applicator if the patient feels any pain or burning during treatment.
  • If the Lock Switch is in the locked position it must be placed in the unlocked position to disable the power. Locking the treatment settings is optional and not required for treatment.
  • ALWAYS administer treatment using a new sam® Sport ultrasound coupling patch. Use one sam® Sport ultrasound coupling patch per applicator. Use of the sam® Sport ultrasound applicator without a new sam® Sport ultrasound coupling patch MAY RESULT IN BURN and/or REPEATED SHUTOFF of the sam® Sport applicator.
  • sam® Sport should be kept out of the reach of children.
  • DO NOT apply the sam® Sport applicator with alternative coupling media as a replacement for the sam® Sport ultrasound coupling patch. Use of alternative coupling media in lieu of the sam® Sport ultrasound coupling patches may reduce the effectiveness of treatment, lead to automatic shutoff of the applicator, or cause a burn.
  • DO NOT administer treatment if the applicator is not connected to a sam® Sport ultrasound coupling patch.
  • Applicators and sam® Sport ultrasound coupling patches are not sterile. DO NOT apply this device over an open wound or inflamed skin.
  • Do not use the sam® Sport ultrasound coupling patches if the sam® Sport ultrasound media is dried out. Indications of a dried out patch include: the cup is not full of gel, there is dry residue or film in the cup, or there is any cut, break, or opening in the bandage or seals.
  • DO NOT apply directly over a bone that is near the skin surface.
OK