9.2 CCM Off Status
Under certain conditions, which are listed below, the OPTIMIZER Smart IPG is set to a
special “Off” status:
• Permanent Off: In this state, the OPTIMIZER Smart IPG does not deliver CCM
signals, although it senses and classifies cardiac events. This status can only be
changed by using the OMNI Smart Programmer software to reprogram the
OPTIMIZER Smart IPG under supervision of a physician. The patient or a
physician can force the OPTIMIZER Smart IPG into the Permanent Off state by
placing a magnet over the implant site of the OPTIMIZER Smart IPG and by
maintaining it in close proximity to the device for at least two cardiac cycles (2 - 3
seconds).
Note: This Permanent Off state is maintained even after the magnet is removed
from the implant site.
• DOWN: In this state, the OPTIMIZER Smart IPG does not deliver CCM signals,
and it may not sense cardiac events. Reversal of this state can only be
accomplished by resetting the OPTIMIZER Smart IPG with the OMNI Smart
Programmer software under physician supervision (see Section 21). In the
unlikely event of inconsistent operation of the system’s logic circuits, the
OPTIMIZER Smart IPG will automatically assume the “DOWN” state.
9.3 A/V Sensing
Through leads implanted in the heart, the OPTIMIZER Smart IPG can sense, detect, and
analyze activity in the form of electrical signals generated by the heart, for example,
electrical depolarization events which occur during the cardiac cycle. The controller and
signal generation circuitry of the OPTIMIZER Smart IPG are programmed to receive the
signals detected by electrodes and sensing circuitry and, based on the detected signal,
analyze their characteristics (including, for example, magnitude and timing), and to
determine whether or not to trigger the delivery of the CCM signal, as well as when to
deliver the CCM signal.
9.3.1 A/V Sensing Leads
Right heart events are detected through two sensing leads:
• A lead: lead positioned in the right atrium (A)
• V lead: lead positioned in the right ventricle (V)
9.3.2 A/V Sensing Parameters
A and V polarity and sensitivity are the parameters determining how right heart
events are sensed.
• Sensitivity: With the OMNI Smart Programmer software, the Atrium
sensitivity can be set to any one of 13 values between 0.1 mV and 5.0 mV,
and the Ventricle sensitivity to set to any one of 18 values between
0.1 mV and 10.0 mV.
Note: When the OPTIMIZER Smart IPG is in Active OVO-LS-CCM
mode, the minimum allowable setting for the Ventricle sensitivity is
1.0 mV.
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