7
•
Chronic repositioning.
Optimum threshold performance might not be
achieved if the lead is chronically repositioned because the steroid can be
depleted.
•
Protect from surface contamination.
The lead uses silicone rubber
which can attract particulate matter, and therefore, must always be
protected from surface contamination.
•
No mineral oil on lead tip.
Mineral oil should never come in contact with
the lead tip electrode. Mineral oil on the tip may inhibit tissue ingrowth and
conduction.
•
Ensure suture sleeve position.
Ensure the suture sleeve remains
proximal to the venous entry site and near the terminal boot molding
throughout the procedure until it is time to secure the lead.
Implantation
•
Evaluate patient for surgery.
There may be additional factors regarding
the patient's overall health and medical condition that, while not related to
device function or purpose, could render the patient a poor candidate for
implantation of this system. Cardiac health advocacy groups may have
published guidelines that may be helpful in conducting this evaluation.
•
Lead compatibility.
Prior to implantation, confirm the lead-to-pulse
generator compatibility. Using incompatible leads and pulse generators
can damage the connector and/or result in potential adverse
consequences, such as undersensing of cardiac activity or failure to
deliver necessary therapy.
•
Line-powered equipment.
Exercise extreme caution if testing leads using
line-powered equipment because leakage current exceeding 10 µA can
induce ventricular fibrillation. Ensure that any line-powered equipment is
within specifications.
•
Do not bend the lead near the lead-header interface.
Insert the lead
terminal straight into the lead port. Do not bend the lead near the lead-
header interface. Improper insertion can cause insulation or connector
damage.
•
Vein pick.
The vein pick is not intended either for puncturing the vein or for
dissecting tissue during a cutdown procedure. Be sure that the vein pick
does not puncture the insulation of the lead. This could prevent proper
lead function.
•
Do not bend lead with stylet in place.
Do not bend the lead with a stylet
in place. Bending the lead could damage the conductor and insulation
material.
•
Tools applied to distal end.
Do not apply tools to the distal end of the
lead because lead damage could occur. Avoid holding or handling the
distal tip of the lead.
•
Curving the stylet.
Do not use a sharp object to curve the distal end of a
stylet. Do not curve a stylet while it is in the lead. If a curved stylet is
preferred, gently curve a straight stylet before inserting it into the lead to
avoid damage to the stylet and lead.
