OL1000™ | 合法醫療器材資訊網
CMFOL1000BoneGrowthStimulatorsareportable,battery-poweredmedicaldevicesindicatedforuseinthenoninvasivetreatmentofanestablishednonunion ...
BRIEF PRESCRIBING INFORMATION
INDICATIONS: Noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
CONTRAINDICATIONS: Use of this device is contraindicated in individuals having a synovial pseudarthrosis. Demand-type pacemaker or implantable cardioverter defibrillator (ICD) operation may be adversely affected by exposure to magnetic fields. Physicians should not prescribe CMF 0L1000 for applications that may place the treatment transducers in close proximity to the pacemaker. Further screening by the attending cardiologist is recommended (such as with an electrocardiogram). CMF 0L1000 should not be used in the presence of external or internal fixation devices that are constructed from magnetic materials.
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