Use Instructions

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▪ When OPTIset has completed its proposal of CCM algorithm timing, click
the Accept & Continue button
▪ When the OPTIset window appears again, click the OPTIset: Propose
CCM Amplitude button
▪ When the OPTIset: CCM AMPLITUDE is shown, enable the CCM
Channels (one at a time)
▪ When OPTIset has completed its proposal of CCM algorithm amplitude,
set the CCM Amplitude to 5.0 V and then click the Accept & Continue
button
▪ When the OPTIset window appears again, click the Accept & Continue
button
▪ Click the blinking Program button on the Programming Buttons Pane
to load modified parameters into the OPTIMIZER Smart Mini IPG
o Measure lead impedances by performing the following steps:
▪ Click the Diagnostics button on the Mode Bar
▪ Select the Leads tab
▪ Click the Measure Leads Impedance button
▪ Verify that they are within expected values.
• Under local anesthesia, ask the patient if they feel any sensation while the OPTIMIZER
Smart Mini IPG is delivering CCM therapy. If the patient does not report having any
sensation, increase the CCM amplitude to 7.5 V and repeat sensation check.
• If the patient expresses feelings of discomfort or any other kind of sensation, identify the
lead causing it by disabling the CCM delivery to the RV channel. If this has no effect, re-
enable the RV channel and disable the LS channel. If possible, the lead causing
sensations should be relocated to allow cardiac contractility modulation therapy to be
delivered at the maximum amplitude.
• Once the leads are in place, secure each lead to its respective lead anchor sleeve. Clean
the lead body with sterile saline before securing the anchoring sleeve to the lead. Secure
the anchoring sleeve with two non-absorbable ligatures and tighten gently -- Do Not
Over-Tighten.
Note: Any significant lead impedance deviation at a subsequent check-up may be a sign of lead
displacement or indicative of another problem requiring further investigation.
8.7 Dissection of the IPG Pocket
Blunt dissection directly on top of the fascia is the preferred method for creating the pocket, which
should be just large enough to accommodate the OPTIMIZER Smart Mini IPG and any loops of
excess lead.
Note: When dissecting the pocket, please bear in mind that for charging to be possible, the
distance between charging wand and OPTIMIZER Smart Mini IPG must not exceed 1.5 in.
Inserting the OPTIMIZER Smart Mini IPG and Closing the Pocket
Insert the OPTIMIZER Smart Mini IPG into the subcutaneous pocket. Although the OPTIMIZER
Smart Mini IPG can theoretically be interrogated and charged in any position, the preferred
placement is such that the engraved side of the device is facing superior towards the skin, which
provides the best link between the charging coil inside the header and the Vesta Charger.
While the OPTIMIZER Smart Mini IPG may be implanted at a depth of up to 1.5 in, the maximum
recommended depth of implant for proper device interrogation and charging is 1 in.