Use Instructions

When placing the IPG into the subcutaneous pocket, take special care to allow a smooth

curvature of redundant lead segments within the pocket and place them around the IPG or in the

pocket inferior to the device. Secure the IPG to the fascia with a non-absorbable suture and close

the pocket.

Radiographs should be obtained after device implantation to verify device and lead placement as

well as rule out pneumothorax, even if there are no symptoms. Thereafter, patients should

receive standard post-operative care for a minimum of 24 hours prior to discharge.

Prior to discharge, check the lead sensitivity threshold for each implanted lead, measure the lead

impedance, and then compare these results to the values obtained during implant. Any significant

changes may indicate lead dislodgement.

Note: As the depth of the implant increases, the efficiency by which the charger is able to charge

the implanted device decreases. This may impact the time it takes to charge the implanted device

Note: If the patient is also implanted with an ICD, concomitant device interaction testing should

be performed (see Appendix III).

9.0 DEVICE EXPLANTATION / REPLACEMENT

9.1 Device Removal

Important points to consider when explanting the OPTIMIZER Smart Mini IPG include:

• Special care should be exercised when opening the IPG pocket so as to not damage the

leads implanted with the OPTIMIZER Smart Mini IPG.

• When loosening a set screw, always insert the tip of the torque wrench fully into and in

line with the set screw. Do not insert the torque wrench into the set screw at an angle.

• If the OPTIMIZER Smart Mini IPG is being explanted and not replaced, abandoned leads

need to be capped after they are disconnected from the IPG.

Carefully open the IPG pocket and gently remove the IPG from the pocket. Once the IPG is out of

the pocket, loosen the set screws with a sterile #2 Allen wrench. When all the set screws have

been loosened, grasp the connector of a lead between the thumb and forefinger of one hand

while holding the IPG in the other hand, and pull the lead connector from the terminal by cautious

application of constant traction.

Note: Grasping the lead connector with a sterile pad can help improve traction.

Caution: Never apply traction to the actual lead body; it could damage the lead and result in lead

failure.

9.2 Device Replacement

Important points to consider when replacing the OPTIMIZER Smart Mini IPG include:

• When tightening a set screw, always insert the tip of the torque wrench fully into and in

line with the set screw. Do not insert the torque wrench into the set screw at an angle.

• Make sure to visually verify that the lead insulation is intact when replacing an

OPTIMIZER Smart Mini IPG. Prior to connecting the leads to the replacement IPG, the

impedances and sensing thresholds should be assessed with a Pacer System Analyzer

(PSA).

• Prior to inserting the IS-1-BI 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.