Use Instructions

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10.3 Extend on Low CCM%
If the percentage of CCM therapy a patient receives during scheduled CCM therapy delivery
periods is lower than 90%, the OPTIMIZER Smart Mini IPG offers the option of extending this
CCM therapy delivery time period. When the Extend on Low CCM% feature is enabled, the
OPTIMIZER Smart Mini IPG extends the On Time period for CCM therapy delivery based on the
percentage of CCM therapy delivered during the original 1 hour On Time period. The amount in
which the On Time is extended is as follows:
• If the CCM% is 80% to 90%, the On Time is extended 11%
• If the CCM% is 70% to 79%, the On Time is extended 26%
• If the CCM% is 60% to 69%, the On Time is extended 46%
• If the CCM% is less than 60%, the On Time is extended 72%
In all cases, the Off Time is correspondingly reduced by the same amount.
10.4 Suspension of CCM Delivery
The OPTIMIZER Smart Mini IPG will suspend the delivery of CCM therapy if the following
conditions are present:
• CCM Magnet Mode: In this state, the OPTIMIZER Smart Mini IPG still senses and
classifies cardiac events. A health care provider (or patient) can force the OPTIMIZER
Smart Mini IPG into the CCM Magnet Mode state by placing a cardiac device magnet
(minimum field strength of 90 Gauss @ 1.5 in) over the implant site of the OPTIMIZER
Smart Mini IPG and by maintaining it in close proximity to the device for at least two
cardiac cycles (2-3 seconds). This CCM Magnet Mode state is maintained even after the
magnet is removed from the implant site. The CCM Magnet Mode has two setting
options:
o Off 1 day: At this setting, the OPTIMIZER Smart Mini IPG shall remain in a CCM
Off state for 24 hours. This 24 hour period starts the moment the magnet is
moved away from the implanted device. When this 24 hour period has been
completed, the device will resume delivering CCM therapy using the previously
programmed parameters.
Note: If at any time during this 24 hour period, a cardiac device magnet is
reapplied over the implant site of the OPTIMIZER Smart Mini IPG for at least two
cardiac cycles (2-3 seconds) and then removed again from the implant site, the
24-hour period is restarted.
o Off: At this setting, the OPTIMIZER Smart Mini IPG shall remain in a CCM
Permanent Off state until the Program command is sent to the device. This
status can only be changed by using the OPTIMIZER Smart Mini Programmer
application to reprogram the OPTIMIZER Smart Mini IPG under the direction
and/or supervision of a physician.
• DOWN Mode: In this state, the OPTIMIZER Smart Mini IPG may not sense cardiac
events. The reversal of this state can only be accomplished by resetting the OPTIMIZER
Smart Mini IPG with the OPTIMIZER Smart Mini Programmer application under the
direction and/or supervision of a physician. In the unlikely event of inconsistent operation
of the system’s logic circuits, the OPTIMIZER Smart Mini IPG will automatically assume
the “DOWN” state until it is reset.