Use Instructions

16
CSL
CSL Warnings
• The Carotid Sinus Lead is a single-use-only
device. Do not re-sterilize or reuse. Reuse of
this product may result in malfunction or
adverse events such as infection or death.
• Do not implant product if expiration “Use By”
date has been reached.
• Do not implant the Carotid Sinus Lead if the
storage package has been damaged, compromising the product sterility.
• This system carries associated risks of lead placement-related trauma to the
carotid sinus and surrounding periarterial tissues, including the regional nerves
and the jugular and hypoglossal veins.
• Persons allergic to silicone, platinum, iridium, or stainless steel may suffer an
allergic reaction to lead placement.
• Only physicians who have appropriate experience in carotid artery surgery and
device-specific training should perform implant of the Carotid Sinus Lead.
• Patients who manipulate the Carotid Sinus Lead through the skin may damage
or disconnect the lead from the IPG resulting in loss of therapy.
• Lead malfunction could cause painful stimulation and/or stimulation of
adjacent tissue.
CSL Precautions
• Do not store the Carotid Sinus Lead outside the temperature range of -4° F (-
20°C) to 122° F (50C).
• Sterile package seal integrity can be damaged by moisture. Do not expose to
liquids.
• Electrocautery at a low but effective power can be used to minimize the
potential of damaging the lead during dissection. Electrocautery at high power
settings may damage the Carotid Sinus Lead.
• Scalpels may damage the Carotid Sinus Lead. Avoid scalpel blade contact with
the lead when using scalpels.
• Do not implant the Carotid Sinus Lead if the device has been dropped.
• Exercise extreme caution in utilizing line-powered equipment in conjunction
with the Carotid Sinus Lead because leakage current could injure the patient.
• Do not use any other lead beside the Carotid Sinus Lead with this system
because such use may damage the IPG or injure the patient.
• An additional Carotid Sinus Lead should be available in the event of
compromised sterility or if damage is induced during surgery.