Use Instructions

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Open the shelf box outside the sterile field and remove the TYVEK/PETG molded insert.
Establish a link between the IPG and the Programmer by performing the following steps:
1. Place the Intelio Programming Wand over the OPTIMIZER Smart Mini IPG
2. Open the Optimizer SM application on the Intelio Programmer
3. Click on the Start OPTIlink button shown on the OPTIlink Session Pane
4. If the link is successful, the OPTIlink Session Pane will display the device model and
serial number along with a button Close OPTIlink. In addition, the CCM Status Pane will
display the current CCM therapy status.
Once the programmer is linked to the IPG, proceed to opening the sterile OPTIMIZER Smart Mini
IPG package.
To open the sterile package, proceed as follows:
1. Starting at the provided tab, peel back the TYVEK from the outer PETG molded insert,
taking care not to touch the sterile inner package.
2. Maintaining strict sterile technique, make the inner sterile blister pack accessible to the
scrub nurse. The inner TYVEK/PETG container can be removed from the outer tray with
a pair of forceps inserted at the recess next to the molded tab.
3. Peel back the inner cover starting at the provided peel tab.
4. Remove the OPTIMIZER Smart Mini IPG and the accessories from the inner pack and
place them on a sterile and lint-free surface.
8.4 Connecting the Implanted Leads to the OPTIMIZER Smart Mini IPG
Prior to connecting the implanted leads to the OPTIMIZER Smart Mini IPG, it is recommended
that each ventricular lead be tested with a Pacing System Analyzer (PSA).
Using a PSA, measure the impedance and sensing amplitude for each implanted ventricular lead.
It is also recommended that the pacing capture threshold, which is a traditional indicator of proper
electrode anchoring into the myocardium, be measured for each ventricular lead. Lastly, test each
ventricular lead for stimulation and discomfort.
Acceptable values for ventricular lead assessment are as follows:
• Lead impedance: between 250 Ω and 1500 Ω with no more than 20% fluctuation in
readings
• Sensing amplitude: ≥ 5 mV
• Pacing Capture Threshold: ≤ 1 V at 0.5 ms pulse width
• No palpable diaphragmatic stimulation or chest discomfort with the delivery of an 8 V
pacing pulse at 1.0 ms pulse width
Important points to consider when connecting the implanted leads to the OPTIMIZER Smart Mini
IPG include:
• When tightening or loosening the set screws, always insert the tip of the torque wrench
fully and in line with the set screw. Do not insert the wrench into the set screw at an
angle.
• Prior to inserting the IS-1 lead connectors, visually verify that none of the set screws
protrude into any of the IPG header cavities (please refer to the diagram on the IPG).
Back off any set screw found protruding beyond the wall into the header cavity by turning
it back with the Allen wrench in a counter-clockwise direction. Turn the set screw just
enough so that its tip is no longer inside the header cavity. Do not back the set screw
completely out of the terminal block.
• Under no circumstances should items other than the implantable lead connectors (or Port
Plug) be introduced into the port of the IPG connector terminal.