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OL1000® / OL1000 SC®

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 visible progressive signs of healing.

Contraindications

• Use of these devices is contraindicated in individuals having a synovial pseudarthrosis.
• Demand-type pacemaker operations may be adversely affected by exposure to magnetic fields. Physicians should not prescribe the OL1000 or OL1000 SC for applications that may place the treatment transducers in close proximity to the pacemaker. Further screening by the attending cardiologist is recommended (such as an electrocardiogram).
• The OL1000 or OL1000 SC should not be used in the presence of external or internal fixation devices that are constructed from magnetic materials. (NOTE: Almost all fracture fixation devices implanted today are made from nonmagnetic materials).

Warnings

• The safety and effectiveness of these devices on individuals lacking skeletal maturity has not been established.
• Animal studies conducted to date do not suggest any long-term significant adverse effects from use of these devices. However, long-term effects in humans are unknown.
• Teratological studies have not been performed with these devices. The safety of use of these devices during pregnancy or nursing in humans has not been established.

Precautions

• Weight bearing is not advised in the presence of extreme motion at the nonunion site.
• In the presence of a malaligned nonunion, careful consideration of the use of these devices must be undertaken on an individual basis, as treatment with this device is not intended to alter or affect the degree of malalignment.
• The safety and effectiveness of the use of these devices on individuals with nonunion secondary to, or in conjunction with, a pathological condition has not been established.
• These devices should not be used if there are mental or physical conditions which preclude patient compliance with the physician and device instructions.
• When conditions of atrophy are present or when fractures have remained unhealed for long periods of time, results may be less successful results.

Precautions

• No known significant adverse effects have resulted from the use of these devices.

 

OL1000 and OL1000 SC are registered marks of dj Orthopedics, LLC

CAUTION: Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices to use or order the use of the device.

 

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