The OPTIMIZER Integra CCM-D IPG, part of the OPTIMIZER Integra CCM-D System is
intended for use in an electromagnetic environment as specified below. The patient
implanted with the OPTIMIZER Integra CCM-D IPG must ensure that it is used within the
specified environment.
The Optimizer Integra CCM-D IPG is a life-support device. Essential Performance of the
OPTIMIZER Integra CCM-D IPG:
• The IPG shall be able to detect and discriminate ventricular tachyarrhythmias.
• The IPG shall be able to deliver anti-tachycardia therapy, including ATP and
defibrillation shocks.
• No changes in the settings of tachycardia arrhythmia detection or discrimination
shall occur unless programmed.
• No changes in the settings of anti-tachycardia therapies shall occur unless
programmed.
• ATP and/or shocks shall not be inappropriately delivered.
• The IPG shall be able to detect profound ventricular bradycardia (< 40 bpm) and
post-shock bradycardia (< 60 bpm).
• The IPG shall be able to deliver anti-bradycardia pacing therapy
• No changes in the settings of anti-bradycardia therapies shall occur unless
programmed.
• Pacing shall not be inappropriately delivered.
CCM therapy is not life-support. CCM shall be delivered with safe settings. It is allowable
that these settings disable CCM stimulation.
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Note: In case of emergency, placing a pacemaker magnet over the implant site of the
OPTIMIZER Integra CCM-D IPG and maintaining it in close proximity to the device, sets
the OPTIMIZER Integra CCM-D IPG into Magnet Mode, suspending CCM therapy and
inhibiting the delivery of antiarrhythmic therapies.
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