Confidential – Training Information Slide 1 C-Pulse® Implantable Counterpulsation Pump Advanced...

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Confidential – Training Information Slide 1 C-Pulse® Implantable Counterpulsation Pump Advanced Programmer Operation BL 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 l’usage de chercher compétent

Transcript of Confidential – Training Information Slide 1 C-Pulse® Implantable Counterpulsation Pump Advanced...

Page 1: Confidential – Training Information Slide 1 C-Pulse® Implantable Counterpulsation Pump Advanced Programmer Operation LBL 02759-E Advanced Programmer Operation.

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 OnlyInstrument de recherché Réservé uniquement à l’usage de chercher compétent

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Programmer Operating Screen

Real-time data

area

Immediate adjustments area

Menus

Current Pt IDCurrent rhythm

stability classification

Current parameter set

Changes to these parameters take effect immediately – similar to IABP.

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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.

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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

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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

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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

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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

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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.

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Display/Event Log Shows any alarms that have occurred

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Display/Event LogFilter allows selection of type of events to be displayed

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Tools menu

• Provides capability for performing measurements on real-time data waveforms.

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Tools/Measure

Measure ECG Amplitude (mV)

Measure Time (sec)

Measure Gas Pressure (mmHg)

Menu allows selection of 3 measurement tools

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Help menu

• About shows information about the current driver and programmer including software and hardware version information

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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

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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.

Tammy Davis
I would move this to the section when you are explaing the TIV/IHP optimizing
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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)

Tammy Davis
Does this go away after "confirming the parameters" on the driver?
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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)

Tammy Davis
You should repeat this tye of slide for each of the parameters that they measure. Also, the order should be the same as in the Tip Cards [see Intra-Op and Follow-Up] The order of all of these slides should be consistent.
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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

Tammy Davis
This can go at the end when they are optimizing. I would like for the Quick basic required timing measurement/actions to be together and all of the more advance optimizing slides to follow after the required slides
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Confirming Deflation Timing Latency at Implant

• With delay set to ZERO, latency should be at least 120 msec to ensureability 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 timing2. 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

Tammy Davis
We should always show an slide with real measurements not what they will never see in real life.
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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

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Adjusting ECG detection parameters

Variable R-wave detection threshold Sensitivity 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:

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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.

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Adjusting ECG detection parametersClinical 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

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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.

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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.

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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

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Viewing Reports from a Memory Stick

1. Open Patient folder from memory stick2. Select file (name includes date & time)3. Open HTML file in browser