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Section 6: Transform Treatment
Information
6.1 Indications for Use
The EvolveX System with the Transform Applicator units employs RF
technology and EMS-TENS technology for the treatment of selected medical
conditions.
The Transform Applicator in RF mode is intended for the temporary relief of
minor muscle aches and pain, temporary relief of muscle spasm, and
temporary improvement of local blood circulation.
The Transform Applicator in EMS mode is intended for:
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous
thrombosis
The Transform Applicator in TENS mode is intended for:
• Symptomatic relief and management of chronic, intractable pain
• Post-surgical acute pain
• Post-trauma acute pain.
6.2 Contraindications
Contraindications in the use of the EvolveX System in RF mode include:
▪ Pacemaker or internal defibrillator, or any other active electrical
implant anywhere in the body.