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Monitor the patient’s blood glucose levels in the perioperative period and instruct the patient to
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continue to monitor glucose levels as they may fluctuate as a response to surgery or to complications.
Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative
management of patients with diabetes.
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Closely monitor patients for signs of infection, delayed wound healing, or cerebrospinal fluid (CSF)
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leakage as the severity of these complications may be greater in patients with diabetes.
Stimulation modes.
The BurstDR™ stimulation mode has not been evaluated for effectiveness in the
diabetic peripheral neuropathy (DPN) population.
System components.
The use of components not approved for use by Abbott Medical with this system may
result in damage to the system and increased risk to the patient.
Power supply.
Use only the CR2450 batteries supplied with the device. CR2450 batteries have a nominal
voltage of 3V and nominal capacity of at least 600 mAh.
Precautions
The following precautions apply to these components.
General Precautions
Clinician training.
Clinicians should be experienced in implanting neurostimulation devices and should have
undergone sufficient surgical and device implantation training.
Patient selection.
It is extremely important to select patients appropriately for neurostimulation. Thorough
psychiatric screening should be performed. Patients should not be dependent on drugs and should be able
to operate the neurostimulation system.
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