Impulse Dymanics OPTIMIZER Smart System - Opening the Lead Sterile Package(S); Opening the OPTIMIZER Smart Sterile Package

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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.
Warning: In order to prevent vascular injury and hemorrhage, be extremely
cautious when introducing catheters and leads into arteries and veins.
7.2 Opening the Lead Sterile Package(s)
Visually inspect the lead packages before opening them for 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/PET molded
tray.
• Using the provided tab, peel back the TYVEK from the outer PET molded tray,
taking care not to touch the inner sterile package.
• Using strict sterile technique, open the inner sterile blister pack and make it
accessible to the scrub nurse. At the recess adjacent to the molded tab, the inner
TYVEK/PET 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.
7.3 Opening the OPTIMIZER Smart Sterile Package
The OPTIMIZER Smart IPG is supplied in a shelf box that contains a literature pack and
the sterile package sterilized with ethylene oxide gas. The sterile package comprises an
outer TYVEK/PET blister pack containing an inner TYVEK/PET blister. Visually
inspect the package before opening it for the implantation procedure. Please contact your
Impulse Dynamics representative if package or seal is damaged. The inner blister pack
contains:
• One (1) OPTIMIZER Smart IPG
• One (1) Allen #2 torque wrench (11 oz-in = 77.68 mNm)
• One (1) Port Plug
Open the shelf box outside the sterile field and remove the TYVEK/PET molded insert.
To open the sterile package, proceed as follows:
• Starting at the provided tab, peel back the TYVEK from the outer
PET molded
insert, taking care not to touch the sterile inner package.
• Maintaining strict sterile technique, make the inner sterile blister pack accessible
to the scrub nurse. The inner TYVEK/PET container can be removed from the
outer tray with a pair of forceps inserted at the recess next to the molded tab.
• Peel back the inner cover starting at the provided tab.
• Remove the OPTIMIZER Smart IPG and the accessories.