Use Instructions

13
8.0 DEVICE IMPLANTATION
8.1 General Considerations
Generally, the OPTIMIZER Smart Mini IPG is implanted in the right pectoral region of the chest.
Two right ventricular leads are placed for CCM therapy delivery, one of these preferably in an
anterior septal and the other in a posterior septal location, approximately half way between base
and apex. Placing both leads in an anterior or posterior septal location is an acceptable
alternative, provided the leads are separated by at least 3/4 in. In patients who have an
implantable ICD, ensure that there is adequate separation between implanted CCM leads and
ICD leads.
An optional atrial lead may be positioned in the right atrial appendage (RAA).
Note: The implantation of an optional atrial sensing lead is recommended if the expansion of
some CCM timing and delivery parameter ranges is required in order to ensure sufficient CCM
therapy delivery. The atrial lead option gives the physician the opportunity to treat patients with
weak ventricular IEGM signals or an intrinsically high sinus rate.
Please follow all indications listed in the lead manufacturer’s literature.
Warning: Avoid Subclavian crush by proper lead access and placement. Patients need to be
monitored closely after the implantation procedure.
Warning: Exercise care while placing the leads to avoid swelling of the steroid plug or formation
of a blood clot, which could prevent extension and/or retraction of the helix.
Warning: It is important to avoid prolonged manipulation of the leads and catheters in the venous
system, which could lead to venous thrombosis.
Warning: During implantation, leads and catheters need to be manipulated with extra caution in
order to avoid perforation of the right ventricular wall. Obtain X-rays, perform
echocardiography, and device interrogation after implantation to detect perforations
even in the absence of corresponding symptoms. Throughout the course of the
procedure and in post-operative care, cardiac hemodynamic and respiratory status
should be continuously monitored by subjective assessment, pulse oximetry, and
blood pressure monitoring via automatic cuff or intra-arterial cannula.
Warning: In order to prevent vascular injury and hemorrhage, be extremely cautious when
introducing catheters and leads into arteries and veins
8.2 Opening the Lead Sterile Package(s)
Visually inspect the lead packages before opening them for implantation. To prepare the lead for
vascular implantation, follow the instructions provided by the lead manufacturer. Unless otherwise
indicated by the lead manufacturer, proceed as follows with each sterile package:
• Open the shelf box outside the sterile field and remove the TYVEK/PETG molded tray.
• Using the provided tab, peel back the TYVEK from the outer PETG molded tray, taking
strict care not to touch the inner sterile package.
• Maintaining strict sterile technique, make the inner sterile package accessible to the
scrub nurse. At the recess adjacent to the molded tab, the inner TYVEK/PETG container
can be removed from the outer tray with a pair of forceps.
• Peel back the inner cover starting at the provided peel tab.
• Remove the lead from the inner package and place it on a sterile and lint-free surface.
8.3 Opening the OPTIMIZER Smart Mini Sterile Package
Caution: Visually inspect the package before opening it for the implantation procedure. Check
the package for any signs of damage suggesting that the sterility of the package or its contents
has been compromised. Damaged packages should be returned to Impulse Dynamics for
evaluation. Do not attempt to resterilize any of the contents of the sterile inner blister pack that
has been damaged or compromised.