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Description
INDICATIONS: These devices offer a noninvasive approach to treating well-established nonunion fractures caused by trauma, with the exclusion of vertebrae and all flat bones. An established nonunion is characterized by the absence of visible and ongoing signs of healing at the fracture site.
CONTRAINDICATIONS: The utilization of this device is not recommended for individuals with synovial pseudarthrosis. Exposure to magnetic fields may have adverse effects on the operation of demand-type pacemakers or implantable cardioverter defibrillators (ICDs). Physicians should exercise caution and avoid prescribing the CMF 0L1000 for treatments that could potentially place the treatment transducers in close proximity to the pacemaker. Additional evaluation by the attending cardiologist is advisable, which may include conducting an electrocardiogram. Furthermore, the CMF 0L1000 should not be employed when external or internal fixation devices are constructed from magnetic materials. It’s important to note, however, that most modern fracture fixation devices are typically made from nonmagnetic materials.
(NOTE: Almost all fracture fixation devices implanted today are made from nonmagnetic materials.)
WARNINGS: The safety and efficacy of employing this device on individuals who have not yet reached skeletal maturity have not been verified. Although animal studies conducted thus far have not indicated any significant long-term adverse effects resulting from the device’s use, its long-term impact on humans remains uncertain. Additionally, there have been no teratological studies conducted to assess the device’s potential effects on fetal development. Therefore, the safety of using this device during pregnancy or while nursing in humans has not been determined.
PRECAUTIONS: Weight-bearing activities are not recommended when there is excessive movement at the nonunion site. In cases of a misaligned nonunion, careful consideration should be given to the use of this device on an individual basis. It’s important to note that this device is not intended to correct or influence the degree of misalignment. The safety and effectiveness of using this device on individuals with nonunion fractures resulting from or in combination with a pathological condition have not been established. Furthermore, this device should not be used if there are mental or physical conditions that would hinder the patient’s ability to comply with the instructions provided by the physician and device. In situations where atrophy is present or when fractures have remained unhealed for extended periods, achieving successful results may be more challenging.
ADVERSE EFFECTS: No known significant adverse effects have resulted from the use of this device. Clinical studies, animal studies, and tissue culture experiments conducted with the OL1000, which has the same treatment signal as the OL1000 SC1, have not indicated any evidence of significant adverse effects.
CAUTION: Federal law (U.S.A. and Canada) restricts this device to sale, distribution or use by or on the order of a physician.
