Abbott 3599 - Page 9

Lead movement. Paents should avoid bending, twisng, stretching, or liing objects over 2 kg (5 lb) for six
to eight weeks posmplantaon. Extension of the upper torso or neck may cause lead movement and alter
the smulaon eld, resulng in oversmulaon or ineecve smulaon.
Operaon of machines, equipment, and vehicles. Paents using therapy that generates paresthesia should
turn o smulaon before operang motorized vehicles, such as automobiles, or potenally dangerous
machinery and equipment because sudden smulaon changes may distract them from properly operang
it. However, current data shows that most paents using BurstDR™ smulaon therapy do not experience
paresthesia. For paents who do not feel paresthesia, sudden smulaon changes are less likely to occur
and distract them while operang motorized vehicles, machinery, or equipment.
Postural changes. Changes in posture or abrupt movements can change the level of smulaon and
potenally cause unpleasant sensaons. Paents should turn smulaon o or lower the amplitude before
stretching, liing their arms over their head, or exercising. If unpleasant sensaons occur, turn o
smulaon.
Pediatric use. Safety and eecveness of neurosmulaon for pediatric use have not been established.
Pregnancy and nursing. Safety and eecveness of neurosmulaon for use during pregnancy and nursing
have not been established.
Use in paents with diabetes. Surgical complicaons and adverse eects may be more frequent and severe
in paents with diabetes. The following addional consideraons should be made for paents with
diabetes:
▪ A pre-operave risk assessment should be performed for paents with diabetes who are at high risk for▪
ischemic heart disease, those with autonomic neuropathy or renal failure, and paents with a
Hemoglobin A1C (HbA1c)
≥
8
%
(64 mmol/mol).
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