Set-up Guide
Prepare the IVL Generator

1. Power On
Press Power button. The light willturn green.

2. Detach Cable
Detach Charger Cable from theIVL Generator and confirm charge.

3. Cover Cable with Sterile Sleeve
Make sure Connector Cable in encasedin a Sterile Sleeve. For more information,please reference Instructional Video on
Shockwavemedical.com.

4. Attach Connector Cable
Slide the Connector Door to the left
and insert the Proximal end of theConnector.

Prepare and Insert the IVL Catheter
Diameter (mm)

2.5

3.0

3.5

Length (mm)12Max Pulse Count

120GuidewireCompatibility (in)0.014”

Guide Catheter
Compatibility

5F

Working Length(cm)138

Max Crossing
Profile (in)

.044

.045

4.0
Distal Marker.045

Proximal Marker.047

1. Size Appropriately
Select catheter 1:1 with intended
stent size to ensure apposition &optimal energy transfer.

2. Remove Catheter
Remove catheter from sterile
packaging, tray, loop and protective
sheath.

3. Prepare Balloon
Use standard balloon prep with
50/50 saline contrast mixture. Pullvacuum at least three times toensure air is completely removed.

Deliver IVL Therapy

1. Inflate Balloon
Inflate to 4 atm and confirm no air isin the catheter.

4. Connect Catheter
Connect proximal end of IVL Catheter
to Connector Cable in Sterile CableSleeve.

5. Advance & Position
Advance the IVL Catheter over.014” guidewire and position using
standard technique.

Do not exceed 80 pulses within a 12 mm segment

2. Activate
Press “Therapy” button to enable
delivery of pulses - Light will turnfrom orange to green on generator
and connector cable; to disable,press “Therapy” button again.

3. Delivery Pulses
4. Expand to Nominal
Press and hold connector cable
Expand to RVD at 6 atm and deflate.
button to pulse; audible clicks andflashing LED confirm therapy delivery;
don’t exceed 80 pulses in 12 mmsegment.

5. Reposition Catheter
Deliver at least 20 pulses in each
12 mm segment; deliver pulses until
desired luminal gain is achieved
under angiography; Overlap by 2
mm when repositioning catheter totreat another segment.

IVL Troubleshooting
Generator Error 88(Most Commonly Associated with Air in Catheter)
1. Power off generator
2. Check catheter & connector cable connections
a. Ensure sterlie sleeve is not interferingb. Ensure generator connector door is notpreventing the cable from being fully inserted
3. Purge and re-prep the balloon
a. Use syringe to purge air from catheter withnegative pulls 2-3X
b. Use syringe with 50/50 saline-contrast mix to
top off catheter port
c. Remove air from indeflator through verticalexpression of air
d. Connect to hub and purge with multiple-backs

Generator Error 87(Most Commonly Associated with Data
Transmission Error)
1. Power off generator
2. Check catheter & connector cableconnections
a. Ensure sterlie sleeve is not interferingb. Ensure generator connector door is notpreventing the cable from being fully inserted
3. Power on generator
4. Press therapy button when ready
5. Resume pulse delivery
6. If error condition persists, replace the catheter

Benign, Intermittent Ventricular Capture
and/or Artifact May Be Observed on ECG
If patient heart rate is <60 bpm, IVL’s pressure waves may lead to pacing as
it will be the fastest pacer (for 10 seconds during delivery of pulses).
No electricity leaves the IVL catheter – the temporary capture is causedby the IVL catheter’s release of mechanical energy in close proximity tomyocardium.
41% of patients within Shockwave’s pivotal study experienced IVL-inducedcapture. IVL capture did not result in sustained ventricular arrhythmias andwas not associated with adverse events1.
If patient’s blood pressure drops simultaneously, cease delivery of pulses
and allow time for patient to tolerate therapy.

4. Power on generator
5. Press therapy button when ready
6. Resume pulse delivery
7. If the error condition persists, replace the catheter
1. Hill, J. M., Kereiakes, D. J., Shlofmitz, R. A., Klein, A. J., Riley, R. F., Price, M. J., . . . Stone, G. W. (2020). Intravascular lithotripsy for treatment ofseverely calcified coronary artery disease. Journal of the American College of Cardiology, 76(22), 2635-2646. doi:10.1016/j.jacc.2020.09.603

Please contact your local Shockwave representative for specific country availability and refer to theShockwave C2+ coronary catheter instructions for use containing important safety information.

© 2022 Shockwave Medical, Inc. All Rights Reserved. SPL-66118 Rev. B