The main variables that may have an impact on CCM events leading to atrial
activation are the location of lead placement on the right ventricular septum,
CCM amplitude, and CCM delay. To prevent the occurrence of atrial arrhythmias
due to CCM signal delivery, it is recommended that basal lead implant locations
be avoided. The potential for direct atrial activation by CCM signals can be tested
during the implant by delivering the strongest possible CCM signal 20 to 30 ms
longer than the LS-CCM delay with which the IPG will be ultimately
programmed, as long as this delay places the CCM signal, including its 40 ms
balancing phase, completely within the ventricular absolute refractory period, and
monitoring for atrial activations. In such a case, the delay should be programmed
to a longer value and lack of atrial activation confirmed. Besides proper lead
location and CCM parameter programming, the “Atrial Tachycardia Rate” must
be programmed to a sufficiently low value as a protective measure against atrial
arrhythmias that could be induced by CCM signal delivery.
4.3 Handling
Do not implant the OPTIMIZER Smart IPG if the package is damaged or if the device
has been dropped onto a hard surface from a height of 30 cm (12 in) or more while still in
the shipping box. Do not implant the device if it has been dropped onto a hard surface
after unpacking. Damaged packages or dropped devices need to be returned to Impulse
Dynamics.
4.4 Storage and Handling
The recommended storage temperature range for the OPTIMIZER Smart IPG is 32°F to
104°F. Atmospheric pressure and relative humidity have no impact on the OPTIMIZER
Smart IPG.
4.5 Packaging Information
The OPTIMIZER Smart IPG is supplied in a shelf box containing a literature pack and
the sterile package. The sterile pack has been sterilized with ethylene oxide gas and
comprises an outer TYVEK/PET blister pack containing an inner TYVEK/PET blister.
The following items are included in the shelf box:
• OPTIMIZER Smart System Physician’s Manual
• OPTIMIZER Smart System Patient’s Manual
• Peel-off labels for use with implantation documents
• Sterile pack
The inner blister pack contains:
• One (1) OPTIMIZER Smart IPG
• One (1) Allen #2 torque wrench (11 oz-in = 77.68 mNm)
• One (1) Port Plug
Before opening the sterile package, check for any signs of damage suggesting that the
sterility of the package or its contents might have been compromised. Damaged packages
need to be returned to Impulse Dynamics. Do not attempt resterilize the contents of the
sterile package that has been damaged or in any way compromised.
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