APPENDIX III
Communications/Telemetry
Between the OPTIMIZER Smart IPG and the OMNI Smart Programmer:
• OPTIMIZER Smart IPG to OMNI Smart Programmer:
o PPM: “0” = 180 µs, “1” = 270 µs
o 14.5 kHz LC excited by pulse
o 1 cycle per pulse until dampened to 10%
o Energy invested per pulse 0.36 µJ → 5.14 mW
peak
per pulse; 1.8 mW
average
• OMNI Smart Programmer to OPTIMIZER Smart IPG:
o AM: “0” = no carrier, “1” = carrier for 305 µs
o 23 kHz carrier frequency
o Power: 0.56 W
peak
; 0.27 W
average
APPENDIX IV
Testing procedure for device/device interaction:
Patients with a concomitant device (e.g. ICD, pacemaker) require additional testing at the
end of the implant procedure to ensure appropriate function of both the OPTIMIZER
Smart IPG and the concomitant device. The steps of the required testing procedure are as
follows:
1. Program the ICD so that it does not deliver antitachycardic therapy during this test.
2. Program the sensing windows of the OPTIMIZER Smart IPG and verify that it can be
programmed to consistently delivery CCM therapy in the presence of the concomitant
device.
3. Activate CCM therapy and analyze the real-time intracardiac electrograms and
marker channels to ensure that the CCM therapy does not cause inappropriate
oversensing during normal sinus rhythm which cannot be resolved by reprogramming
or lead repositioning.
4. Activate CCM therapy and analyze the real-time intracardiac electrograms and
marker channels to ensure that the CCM therapy does not cause inappropriate
undersensing during normal sinus rhythm which cannot be resolved by
reprogramming or lead repositioning.
5. Activate CCM therapy in patients requiring antibradycardic pacing and analyze the
intracardiac electrograms and marker channels to ensure that the CCM therapy does
not cause inappropriate inhibition of antibradycardic pacing which cannot be resolved
by reprogramming or lead repositioning.
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