PRESCRIBING INFORMATION
NOTES
DJO ® SPINALOGIC ® INDICATION: SpinaLogic ® is a portable, battery powered, microcontrolled, noninvasive bone growth stimulator indicated as an adjunct electromagnetic treatmentto primary lumbar spinal fusion surgery for one or two levels. CONTRAINDICATIONS: Use of this device is contraindicated in individuals having a synovial pseudarthrosis. Demand-type pacemaker or implantable cardiovertor defibrillator (ICD) operation may be adversely affected by exposure to magnetic fields. Physicians should not prescribe SpinaLogic 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). SpinaLogic 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 non- magnetic materials.) WARNINGS: Do not use the SpinaLogic near products that may have strong magnetic fields, such as audio speakers. The device may not work properly around these products. WARNING! This device is intended only for single patient use. Secondary use can cause serious injury, including infection. Care must be taken when operating this device adjacent to other equipment. Potential electromagnetic or other interference could occur with this or other equipment. Try to minimize this interference by increasing the separation between this device and nearby equipment, and by not using other equipment (i.e.cell phones, MRI, electro surgery, defibrillation, etc.) when you are using this device. The equipment should not be used adjacent to or stacked with other equipment and, if adjacent or stacked use is necessary,the equipment should be observed to verify normal operation in the configuration in which it will be used. Do not use the SpinaLogic while smoking or near heat, fire or flammable gases because the device may be damaged. Do not use the SpinaLogic if there are exposed wires or the device appears damaged. Do not modify or repair this device because you may damage it. Do not put the device or any of its parts in any liquid. Do not drop the device or bend the coils because this may damage it. Device is designed to comply with electromagnetic safety standards. However, there is no guarantee that interference will not occur in a particular installation. Harmful interference to other devices can be determined by turning this equipment on and off. Try to correct the interference using one or more of the following: reorient or relocate the receiving device, Increase the separation between the equipment, contact DJO ® Customer Care. Some people, with very sensitive skin, may experience redness. Generally, this redness is totally harmless and usually disappears after 10 to 20 minutes. However, never start another treatment on the same area if the redness is still visible. If the performance of the device varies in any way from the described operation, call Customer Care. The use of other cables and accessories may affect EMC performance. This device and its accessories must be kept out of the reach of children, Pets, and Pests. Do not use device in contact with open wounds. Contaminationby Patient could be sweat, expired gases, saliva, on the SpinaLogic. Clean the applied part of the coil once a week using soap and a damp cloth. Do not use device while in bath or shower.
CAUTIONS: DO NOT operate this unit in an environment where other devices are being used that intentionally radiates electromagnetic energy in an unshielded manner. Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
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 SpinaLogic, which has the same treatment signal as the OL1000 ™ and OL1000 SC1, have not indicated any evidence of significant adverse effects.
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