Use Instructions

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Clean each lead connector with sterile distilled water (if using saline, wipe each connector dry
with a surgical sponge afterwards) and fully insert each lead connector into its respective
connector terminal in the header of the OPTIMIZER Smart Mini IPG.
Note: Before tightening the set screws, verify that the tip of each lead connector is fully inserted
into its respective lead tip terminal.
Tighten the tip set screw for each lead using the sterile #2 Allen torque wrench included in the
IPG package. Turn the torque wrench clockwise until you can clearly hear and feel clicking. This
feature limits the amount of torque placed on the set screw and prevents it from being over-
tightened. Carefully apply traction on the strain relief of each lead to make sure that each lead is
securely anchored in their respective terminal.
Tighten the ring set screw for each lead using the torque wrench. Turn the torque wrench
clockwise until you can clearly hear and feel clicking.
9.3 Using a Port Plug with the OPTIMIZER Smart Mini IPG
If an atrial lead is not going to be used with the OPTIMIZER Smart Mini IPG, insert the Port Plug
provided with the OPTIMIZER Smart Mini IPG package into the top port, labeled “A”, of the IPG.
Note: Alternately, any commercially available bipolar IS-1 port plug may be used to plug the atrial
port of the OPTIMIZER Smart Mini IPG.
Tighten the tip set screw. The protruding length of the Port Plug may be shortened, but it is
recommended to leave at least 3/8 in length protruding from the IPG to enable future removal of
the Port Plug if it becomes necessary to connect an atrial sensing lead.
9.4 Disposition of Explanted OPTIMIZER Smart Mini IPGs
All explanted OPTIMIZER Smart Mini 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: An OPTIMIZER Smart Mini IPG or Port Plug that has been explanted for any reason
must not be reused in another patient.
10.0 OPTIMIZER SMART MINI IPG: FUNCTIONS AND PROGRAMMING
OPTIONS
10.1 Device Modes
The implantable OPTIMIZER Smart Mini IPG features three device modes:
• OOO: The device is in standby; no events are sensed and no CCM therapy is delivered.
• ODO-LS-CCM: The device senses atrial, ventricular (RV), and local sense (LS) events
and is capable of CCM therapy delivery.
• OVO-LS-CCM: The device senses RV and LS events while ignoring any atrial events
and is capable of CCM therapy delivery without the need for the detection of atrial sense
events.
10.2 CCM Therapy Mode
The OPTIMIZER Smart Mini IPG features two CCM therapy modes:
• OFF – Turns OFF the delivery of CCM therapy
• ON – Enables the OPTIMIZER Smart Mini IPG to deliver CCM therapy a set number of
hours per day within the timeframe set by the Start Time and End Time parameters. The
delivery of CCM therapy occurs in one hour intervals with pauses in between each
interval for a calculated amount of time based on the hours per day, Start Time, and End
Time parameter settings.
Note: The default setting in the U.S. is for 5 hours of programmed CCM therapy per 24 hours
(repeated intervals of 1 hour ON Time followed by 3:48 hours OFF Time).