• Prior to inserting the IS-1-BI lead connectors, verify visually that none of the set screws
protrudes into any of the IPG header cavities. Back off any set screw found protruding
beyond the wall into the header cavity by turning it back in a counter-clockwise direction
with the Allen wrench. 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.
Clean the lead plugs with sterile distilled water (if using saline, wipe the plugs dry with a
surgical sponge afterwards) and fully insert the plug into the respective connector terminal of the
OPTIMIZER Smart IPG. Observe that the tips of the lead plugs are inserted beyond the
respective lead tip terminals. Tighten the set screws using the sterile #2 torque wrench included
in the OPTIMIZER Smart package. Turn the Allen wrench clockwise until you can clearly hear
and feel the clicking that limits excessive torque on the set screw. Carefully apply traction to the
strain relief of each lead to make sure that the leads are securely anchored in the terminal.
Finally, tighten the set screws securing the contact between the rings of the plugs and the
corresponding parts of the terminal block.
Make sure to visually verify that the lead insulation is intact when replacing an OPTIMIZER
Smart IPG. At this time, the impedances and sensing thresholds should also be assessed with a
PSA.
When the OPTIMIZER Smart IPG is being explanted and not replaced, the remaining implanted
leads need to be capped after they are disconnected from the IPG.
All explanted OPTIMIZER Smart IPGs should be returned to Impulse Dynamics for testing and
analysis, which can provide valuable information on how to further improve device quality and
reliability.
Warning: Never incinerate an OPTIMIZER Smart IPG. The IPG must be explanted before a
deceased patient is cremated.
Warning: Implantable parts are not to be reused if they have previously been implanted in
another patient.
9. OPTIMIZER SMART IPG: FUNCTIONS AND
PROGRAMMING OPTIONS
9.1 Operating Modes
The implantable OPTIMIZER Smart IPG features three operating modes:
• Standby (OOO): The device is in standby; no events are sensed and no CCM
signal trains are delivered.
• Active ODO-LS-CCM: The device senses atrial, ventricular, and local sense
events and is capable of CCM signal delivery.
• Active OVO-LS-CCM: The device senses ventricular and local sense events and
is capable of CCM signal delivery without the need for the detection of atrial
sense events.
To Next Page
Loading...