1. Confidential – Training Information Slide 1 C-Pulse® Implantable Counterpulsation Pump Advanced Programmer Operation LBL 02759-E Advanced Programmer Operation Investigational Device. Limited by federal law to investigational use only. For Clinical Trial Use Only Investigational Device To Be Used by Qualified Investigators Only Instrument de recherché Réservé uniquement à lusage de chercher compétent

2. Confidential – Training Information Slide 2 Programmer Operating Screen Real- time data area Immediate adjustments area Menus Current Pt ID Current rhythm stability classification Current parameter set Changes to these parameters take effect immediately – similar to IABP.

3. Confidential – Training Information Slide 3 Immediate adjustments area Infrared Connection Status Augmentation Mode Change Inflation Volume adjustment Deflation timing adjustment (each click changes time by 2 msec, grey indicates at limit) Connect/disconnect from driver (connection also requires push and hold of the Confirm button on Driver) Enable/Disable Counterpulsation Inflation timing adjustment (each click changes time by 5 msec, grey indicates at limit) Changes to these parameters take effect immediately – similar to IABP.

4. Confidential – Training Information Slide 4 Immediate adjustments area Current Inflation Hold Pressure Current Heart Rate Capture a screen shot of a transduced aortic pressure wave form by partially inflating the cuff for one cardiac cycle; this can then be used for measuring or adjusting timing Start/Stop real time data

5. Confidential – Training Information Slide 5 File menu Save Waveform saves an image of the current real- time data waveforms to a file Open Waveform displays a previously saved waveform file Save Driver Data saves all current driver data (including current parameters, status, and event logs) to file Open Driver Data displays a summary of a previously saved driver data file Patient Information sets the Patient ID written into the driver and used to tag all driver reports. Start Recording/Stop Recording begins/ends background recording to a file of all displayed real- time data. Recording continues indefinitely, but is paused if the display is paused. Shutdown Programmer exits from the programmer application – if driver operating on temporary parameters, it reverts to its permanent parameters

6. Confidential – Training Information Slide 6 Control menu Clear Event Log clears the event log after saving a copy of the current event log to file Set Driver Time adjusts the date and time stored in the driver for inclusion in event logs

7. Confidential – Training Information Slide 7 Parameters menu Allows programming of a range of detailed driver parameters – changes take effect when the Update button is pressed on the selected parameter screen Revert to Saved – if the Driver is currently operating from temporary parameters this will cause it to immediately discard the temporary parameters and revert to its permanently programmed parameters

8. Confidential – Training Information Slide 8 Display menu Zoom selects time base for real- time data between a screen width of 20 sec and a screen width of 1.25 sec Display Waveform selects which waveforms are displayed Event Log shows the current contents of the event log Driver Battery Information displays details about the battery pack currently in the driver such as state of charge Options sets the various options including the default selections for Zoom and Display Waveforms.

9. Confidential – Training Information Slide 9 Display/Event Log Shows any alarms that have occurred

10. Confidential – Training Information Slide 10 Display/Event Log Filter allows selection of type of events to be displayed

11. Confidential – Training Information Slide 11 Tools menu Provides capability for performing measurements on real-time data waveforms.

12. Confidential – Training Information Slide 12 Tools/Measure Measure ECG Amplitude (mV) Measure Time (sec) Measure Gas Pressure (mmHg) Menu allows selection of 3 measurement tools

13. Confidential – Training Information Slide 13 Help menu About shows information about the current driver and programmer including software and hardware version information

14. Confidential – Training Information Slide 14 Programming Operating Parameters Parameters can be changed using: The Immediate Adjustments area on the main screen Individual screens under the parameters menu, followed by pressing Update on the parameter screen All parameter changes are initially only temporary and will be discarded if: The driver is turned off The programmer is turned off The programmer/driver link is broken for more than about 15 seconds Revert To Saved is selected from the Parameters menu Parameters changes can be made permanent by pressing the Confirm button on the driver Confirm Button

15. Confidential – Training Information Slide 15 Optimizing Inflation Volume Increase Target Inflation Volume while monitoring Inflation Hold Pressure (IHP) – aim for IHP 0-20 mmHg above mean arterial pressure Monitor Inflation Hold Pressure relative to blood pressure – IHP will jump when beyond sweet-spot – reduce TIV by 1-2 cc. Volume changes may start a volume calibration cycle – wait until end of cycle before assessing IHP.

16. Confidential – Training Information Slide 16 Adjusting Inflation Timing Transduced aortic pressure waveform; with systolic period visible Use Partial Hold at 1:1 (with zoom at 5 sec or more) to see inflation and deflation timing at current settings Adjust timing using arrows at right (1 click = 5 msec); screen will show previous timing (grey line) and new inflation timing (green line) Repeat Partial Hold and adjustment as required Confirm timing using arterial line, carotid doppler, plethysmography, etc Deflation timing at time of Partial Hold (red line) Inflation timing at time of Partial Hold (grey line) Current (adjusted) inflation timing (green line)

17. Confidential – Training Information Slide 17 Adjusting Inflation Timing Regular vs Irregular Rhythms If rhythm is regular: Driver uses regular timing params Time from dichotic notch to start of inflation should be approx 60 msec (subject to optimization) If rhythm is irregular: Driver uses later irregular timing Repeat measurement several times Time from dichotic notch to start of inflation should be minimum approx 60 msec and average approx 100 msec (subject to optimization) Minimum is likely to be following a long interval (longer fill time is followed by higher ejection volume and ejection time) Time from DN to start of inflation (here 64 msec)

18. Confidential – Training Information Slide 18 Fine Tuning Inflation Timing Use Arterial line, Carotid Doppler, Plethysmography, etc, or Partial Hold to observe timing Measure R-wave to end-of- systole interval time at two heart rates Enter 2 points on Inflation graph into Inflation parameter settings – or drag points on Inflation Timing graph Go to basic screen and re- adjust timing with C-Pulse in 1:1 mode Use Arterial line, Carotid Doppler, Plethysmography, etc, to observe diastolic augmentation Adjust Slew Rate so that augmentation peak is similar to systolic peak

19. Confidential – Training Information Slide 19 Confirming Deflation Timing Latency at Implant With delay set to ZERO, latency should be at least 120 msec to ensure ability to adequately unload LV Use partial hold at 1:1 (with zoom setting at 5 sec or more) to check latency between ECG and start of systole (tools/measure time) At implant: Notes: 1. Latency greater than 220 msec may result if leads on RV and LBBB present and may lead to problems with inflation timing 2. Intermittent V-paced R waves may introduce variability of time from R-wave to beginning of systole – preferentially placing leads on LV reduces this risk

20. Confidential – Training Information Slide 20 Optimizing Deflation Timing During implant, and when arterial line is available, set counterpulsation to 1:2 and use arrows on right side of programmer screen (1 click = 2 msec) to adjust deflation timing for optimal unloading effect If arterial line not available (eg at follow-up), set counterpulsation to 1:1, observe duration of deflation on solenoid trace, use partial hold to determine time to start of systole, and adjust deflation delay accordingly. Very late deflation may be represented by a ski-jump effect at the end of the Cuff inflation hold pressure wave-form. Confirm timing (particularly deflation not late) using carotid doppler, plethysmography, etc. Late deflation may present as little or no unloading, or even reverse unloading. If required, deflation timing can be fine tuned using graph method similar to inflation timing Warning: Care is required if adjusting timing parameters while the patient has an irregular rhythm – deflation timing will be later when the patient reverts to a regular rhythm

21. Confidential – Training Information Slide 21 Adjusting ECG detection parameters Variable R-wave detection thresholdSensitivity setting changes this proportion (high sensitivity = low proportion) Minimum Threshold sets this lower limit The ECG detection algorithm automatically adjusts for ECG amplitude – default parameters are usually OK. If problems are encountered the following parameters can be adjusted:

22. Confidential – Training Information Slide 22 Adjusting ECG detection parameters Sensitivity controls how fast the threshold can change between beats. A higher setting means that detection is more sensitive to a low amplitude R- wave which follows a high amplitude one. However it also makes it more sensitive to T-waves and noise. Minimum Threshold controls the minimum threshold level. This should be set higher than all unwanted signals (eg noise) but well below the R-wave amplitude. Slope adjusts the sensitivity to slow moving signals – changing to Low makes it more sensitive to slow R-waves (eg wide QRS) but needs care as it is also more sensitive to T-waves. Post-Pace Refractory Period is the period after a pace detect during which following artifacts are ignored. Try increasing if problems are encountered with interference from high amplitude pacing pulses, but ensure R-waves are not missed.

23. Confidential – Training Information Slide 23 Adjusting ECG detection parameters Clinical Scenarios Ectopics significantly different in R-wave amplitude to intrinsic beats: Driver may intermittently miss lower amplitude R-waves Increase Sensitivity, but ensure not sensing T-waves or noise Paced beats significantly different in R-wave amplitude to intrinsic beats: Driver may intermittently miss lower amplitude R-waves Increase Sensitivity, but ensure not sensing T-waves or noise R-wave amplitude decreases significantly after implant: If amplitude of R-waves drops below minimum threshold, sensing may become intermittent or lost Reduce Minimum Threshold, but ensure not sensing T-waves or noise

24. Confidential – Training Information Slide 24 Setting Heart Rate Monitoring Parameters Minimum Rate and Maximum Rate set heart rate limits for counterpulsation. Sustained heart rates outside this range will cause the driver to alarm. R-R Interval Count controls the number of beats used for heart rate averaging. R-R Stability Threshold sets the heart rate variability which causes the driver to change to its (more conservative) irregular rhythm timing.

25. Confidential – Training Information Slide 25 Setting Other Parameters Cuff Size should match the actual cuff size implanted and limits the maximum inflation volume that can be selected. Small – 20cc max Medium – 25cc max Large – 30 cc max Partial Hold Volume controls the inflation volume used for a partial hold. MAP Threshold – inflation hold pressure change of more than this will trigger a new volume calibration cycle to keep the inflation volume constant.

26. Confidential – Training Information Slide 26 Transferring Driver Data to a Memory Stick Shortcut opens Reports folder Shortcut opens memory stick Reports folder contains one subfolder for each Patient ID Drag patient folder to memory stick

27. Confidential – Training Information Slide 27 Viewing Reports from a Memory Stick 1.Open Patient folder from memory stick 2.Select file (name includes date & time) 3.Open HTML file in browser