CoolTone® Indications and Important Safety Information
Indications
The CoolTone® device is indicated in adults aged 22 years or older for:
- Strengthening, toning, and firming of the abdomen, buttocks, and thigh muscles
- Stimulation of healthy muscles to improve or facilitate muscle performance; CoolTone® induces muscle contractions to enhance muscle function and may, therefore, be considered a muscle-training technique
- Relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle reeducation, and maintaining or increasing the range of motion
- Use as adjunctive therapy for treating medical diseases and conditions under medical supervision
- Stimulation of neuromuscular tissue for bulk muscle excitation in the legs for rehabilitative purposes
Important Safety Information
CoolTone® treatment is contraindicated when placing the active applicator over metal, active, electrical, or electronic implants/devices in the treatment area like cardiac pacemakers; cochlear implants; intrathecal pumps; implanted defibrillators; implanted neurostimulators; drug pumps; or hearing aids.
CoolTone® is also contraindicated when placing the active applicator over a menstruating uterus; over areas of the skin that lack normal sensation, including areas with disturbance of temperature or pain perception; in patients with fever, malignant tumor, hemorrhagic conditions, infections, epilepsy, pulmonary insufficiency, or pregnancy; following a recent surgical procedure; and over muscles in acute phase of injury.
CoolTone® should be used with caution in patients with Graves disease; in women with an intrauterine device (IUD); and in patients with a hernia in or near the treatment site, active bleeding disorders, or seizure disorders.
Treatment over implantable devices, such as an IUD, in or near the treatment areas may cause migration, damage, or tissue injury. Women with an IUD should monitor for symptoms such as severe abdominal pain, cramping, spotting, or heavy bleeding that develops during or after treatment and seek medical advice if these occur. The CoolTone® system has not been studied in patients with a hernia in or near the treatment site. Use of CoolTone® at or near a recent surgical site may result in rupture.
Women who are close to menstruation may find that it comes sooner, or cramping is increased or intensified with CoolTone® treatments; therefore, it is recommended to not undergo treatment during this time of the month.
CoolTone® should not be used over the heart or head areas, over areas of growth plate, over the carotid sinus nerves, over the neck or mouth, or over areas with impaired arterial blood supply and decreased sensation. CoolTone® should not be applied over swollen, infected, inflamed areas or skin eruptions. Caution should be used for patients with suspected or diagnosed heart problems. Caution is advised when applying stimulation over a scarred area, as there is a risk of burns. If operation instructions are not followed, localized overheating of the tissue is possible.
Ensure that persons with pacemakers are not present in the vicinity of the device during treatment.
Common side effects may include, but may not be limited to, muscular pain, temporary muscle spasm, temporary joint or tendon pain, and local erythema or skin redness.
Consult the CoolTone® User Manual for a complete list of Contraindications, Warnings, Precautions, and potential side effects. Treatment applications that deviate from the guideline.
Before & After
