Abbott 3599 - Precautions; General Precautions

▪ Monitor the paent’s blood glucose levels in the perioperave period and instruct the paent to▪
connue to monitor glucose levels as they may uctuate as a response to surgery or to complicaons.
Implanng physicians or anesthesiologists should consult pracce guidelines for the intraoperave
management of paents with diabetes.
▪
Closely monitor paents for signs of infecon, delayed wound healing, or cerebrospinal uid (CSF)
▪
leakage as the severity of these complicaons may be greater in paents with diabetes.
Smulaon modes. The BurstDR™ smulaon mode has not been evaluated for eecveness in the
diabec peripheral neuropathy (DPN) populaon.
System components. The use of components not approved for use by Abbo Medical
with this system may
result in damage to the system and increased risk to the paent.
Power supply. Use only the CR2450 baeries supplied with the device. CR2450 baeries have a nominal
voltage of 3V and nominal capacity of at least 600 mAh.
Precauons
The following precauons apply to these components.
General Precauons
Clinician training. Clinicians should be experienced in implanng neurosmulaon devices and should have
undergone sucient surgical and device implantaon training.
Paent selecon. It is extremely important to select paents appropriately for neurosmulaon. Thorough
psychiatric screening should be performed. Paents should not be dependent on drugs and should be able
to operate the neurosmulaon system.
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