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Shockwave IVL - User Manual

Shockwave IVL
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LBL 61876 rev. E, March 2018 EN 1
OPERATOR’S MANUAL
Intravascular Lithotripsy (IVL)
Generator and Connector Cable
LBL 61876 Rev E / Revision Date: March 2018
Contents
1.
Introduction ............................................................................................................................................................ 2
1.1 The IVL Generator - How Supplied .................................................................................................................................................................. 2
1.2 Required Devices and Procedure Supplies for Use with the IVL Generator .............................................................................................................. 2
1.3 Device Description ....................................................................................................................................................................................... 2
1.4 Intended Use/Indication for Use ..................................................................................................................................................................... 2
2. Safety Information .................................................................................................................................................. 2
2.1 Terms ........................................................................................................................................................................................................ 2
2.2 Contraindications ......................................................................................................................................................................................... 2
2.3 Dangers ..................................................................................................................................................................................................... 2
2.4 Warnings .................................................................................................................................................................................................... 2
2.5 Cautions ..................................................................................................................................................................................................... 3
3. Product Orientation ................................................................................................................................................. 3
3.1 IVL Generator - Front View ............................................................................................................................................................................ 3
3.2 Control and Indicator Functions ...................................................................................................................................................................... 4
3.3 Front Panel Connectors ................................................................................................................................................................................. 4
3.4 IVL Connector Cable ..................................................................................................................................................................................... 4
3.5 IVL Generator – Rear View ............................................................................................................................................................................ 4
4. Product Use and Therapy Delivery .......................................................................................................................... 5
4.1 Additional Usage Information ......................................................................................................................................................................... 6
5. Installation ............................................................................................................................................................. 7
5.1 IV Pole Mounting .......................................................................................................................................................................................... 7
5.2 Connecting to Line Power .............................................................................................................................................................................. 9
5.3 Charging the Internal Battery ......................................................................................................................................................................... 9
5.4 Environment Conditioning.............................................................................................................................................................................. 9
5.5 Generator Inspection and Test ....................................................................................................................................................................... 9
6. Maintenance .......................................................................................................................................................... 10
6.1 Daily Maintenance .......................................................................................................................................................................................10
6.1.1 Charging and Testing the Internal Battery .............................................................................................................................................. 10
6.1.2 Testing the IVL Generator .................................................................................................................................................................... 11
6.1.3 Inspecting the IVL Generator ............................................................................................................................................................... 11
6.1.4 Cleaning the IVL Generator .................................................................................................................................................................. 11
6.2 Monthly Maintenance ...................................................................................................................................................................................11
6.3 Other Maintenance ......................................................................................................................................................................................12
6.4 Product Useful Life ......................................................................................................................................................................................12
7. Troubleshooting .................................................................................................................................................... 12
8. Appendix A: Electromagnetic Compatibility Guidance ........................................................................................... 13
9. Appendix B: Symbols ............................................................................................................................................. 14
10. Appendix C: Specifications .................................................................................................................................... 15
10.1 Appendix C1: General Specifications ..............................................................................................................................................................15
10.2 Appendix C2: Performance Specifications ........................................................................................................................................................15
NOTE: This Operator’s Manual provides information required for proper operation of the IVL Generator and IVL Connector Cable. Replacement IVL Connector Cables are
available from Shockwave Medical, Inc. Refer to the applicable IVL Catheter Instructions for Use (IFU) for patient treatment information.
To Be Used Exclusively with the Shockwave Medical IVL System.
TEXT CONVENTIONS: Throughout these operating instructions, special text characters (for example, CAPITAL LETTERS such as ON, CATH, SYS) are used to indicate
controls, connectors and lighted annunciators.

Table of Contents

Questions and Answers

  • D
    dcooperAug 16, 2025
    What does it mean if THERAPY STATUS changed from green to yellow on Shockwave Medical Equipment?
    • K
      kevin33Aug 16, 2025
      If the THERAPY STATUS on your Shockwave Medical Equipment changes from green to yellow, the IVL System has automatically paused therapy. The THERAPY STATUS should return to green within the pause period specified in the IVL Catheter IFU.
  • B
    Benjamin WilkinsAug 19, 2025
    What to do if Shockwave IVL displays a system error?
    • B
      Briana JohnsonAug 19, 2025
      If your Shockwave Medical Equipment displays a system error and the power button has a red light, turn the IVL Generator off, wait one second, and then turn it on again. If the problem persists, remove the IVL Generator from service and contact your Shockwave Medical representative.
  • J
    Jeremy HintonAug 22, 2025
    What to do if Shockwave IVL Medical Equipment shows a catheter error?
    • J
      jtrevinoAug 22, 2025
      If your Shockwave Medical Equipment displays a catheter error, ensure the IVL Connector Cable is correctly connected to the IVL Generator and that a valid IVL Catheter is connected to the IVL Connector Cable. If the issue continues, the IVL Catheter or the IVL Connector Cable may have reached the end of its useful life or be defective, requiring replacement.
  • E
    Elizabeth MacdonaldAug 26, 2025
    How to fix Shockwave IVL Medical Equipment not turning on?
    • G
      Gregory HurstAug 26, 2025
      If your Shockwave Medical Equipment unit does not turn on, the battery may need charging. Connect the Charger Module to the IVL Generator and to AC Mains. Allow the IVL Generator to charge for at least twelve hours before use.
  • S
    stewartbrendaAug 28, 2025
    What to do if the THERAPY STATUS indicator on Shockwave IVL does not turn on?
    • C
      Crystal JonesAug 28, 2025
      If the THERAPY STATUS indicator on your Shockwave Medical Equipment does not turn on, ensure a valid IVL Catheter is connected. Verify the IVL Connector Cable is connected to the IVL Generator, and the IVL Catheter is connected to the IVL Connector Cable. If necessary, replace the IVL Catheter.
  • M
    Marcus GibsonAug 31, 2025
    Why Shockwave Medical Equipment battery is not charging?
    • A
      Amy SantiagoAug 31, 2025
      If the battery of your Shockwave Medical Equipment is not charging and the BATTERY CHARGING indicator is off, check the cable connections. Ensure the Charger Module is connected to both the IVL Generator and the AC Mains. Note that two cable connections are required.
  • S
    Stacey GutierrezSep 3, 2025
    What to do if Shockwave Medical Equipment IVL Generator will not activate (THERAPY STATUS is off)?
    • G
      gutierrezkristinSep 3, 2025
      If your Shockwave Medical Equipment IVL Generator will not activate and the THERAPY STATUS is off, refer to the THERAPY STATUS indicator troubleshooting steps.
  • C
    Christine WilcoxSep 6, 2025
    What to do if Shockwave Medical Equipment indicates low battery capacity?
    • M
      Melissa McdanielSep 6, 2025
      If your Shockwave Medical Equipment indicates low battery capacity with an empty battery symbol, the battery likely needs charging. Connect the Charger Module to the IVL Generator and to AC Mains. Allow the IVL Generator to charge for at least twelve hours before use.
  • R
    robertrussellSep 8, 2025
    Why Shockwave Medical Equipment IVL Generator will not activate when THERAPY STATUS is yellow?
    • J
      Jessica HarrisSep 9, 2025
      If your Shockwave Medical Equipment IVL Generator will not activate and the THERAPY STATUS indicator is yellow, it may be because the THERAPY ON/OFF button is pressed. Release the THERAPY ON/OFF button and try again.
  • K
    Kevin BarberSep 12, 2025
    What to do if the Shockwave Medical Equipment IVL Generator doesn't deliver pulses?
    • M
      martinezmelanieSep 12, 2025
      If the THERAPY ON/OFF button is pressed on the IVL Connector Cable, but the IVL Generator does not deliver pulses, consider the following possibilities: 1. If the THERAPY STATUS indicator is off, consult the troubleshooting guide for error messages. 2. If the THERAPY STATUS indicator is yellow, press the THERAPY ON/OFF button once to turn the THERAPY STATUS green. 3. If the THERAPY STATUS indicator is yellow, the IVL System may have automatically paused therapy. The THERAPY STATUS should return to green within the pause period specified in the IVL Catheter IFU. 4. If the THERAPY STATUS indicator is green, the IVL Catheter or IVL Connector Cable may be faulty and need replacement.

Summary

Safety Information

2.2 Contraindications

Outlines conditions under which the IVL system should not be used.

2.3 Dangers

Highlights immediate hazards that could result in serious injury or death.

2.4 Warnings

Details potential hazards that may cause serious personal injury or death.

2.5 Cautions

Identifies practices that could lead to minor injury or equipment damage.

Product Use and Therapy Delivery

Step 1 - Turn the Generator On

Instructions for powering on the IVL Generator and initial system check.

Step 2 - Confirm Battery Capacity

Procedure to verify adequate battery charge before use.

Step 3 - Check Diagnostics

Steps to ensure the generator's diagnostic systems are functioning correctly.

Step 4 - Connect IVL Connector Cable

Guide for connecting the IVL Connector Cable to the generator.

Step 5 - Prepare IVL Catheter for Use

Instructions for preparing the IVL Catheter according to its IFU.

Step 6 - Connect IVL Catheter

Steps for connecting the IVL Catheter to the Connector Cable.

Step 7 - Position the IVL Catheter

Guidance on properly positioning the IVL Catheter within the patient.

Step 8 - Activate the IVL Generator

Procedure to activate the generator and prepare for therapy delivery.

Step 9 - Deliver Therapy

Detailed steps for delivering lithotripsy therapy using the IVL system.

Step 10 - Pause Period; Resume Therapy

Information on how the system manages therapy pauses and resuming treatment.

Step 11 - IVL Catheter End of Life

How the system indicates and handles the end of the IVL Catheter's useful life.

Step 12 - IVL Catheter Replacement

Instructions for safely disconnecting and replacing an IVL Catheter.

Installation

5.5 Generator Inspection and Test

Procedures for inspecting and testing the generator before clinical use.

Step 1 Physical Condition Inspection

Step 2 - Confirm Battery Charging

Step 3 - Turn the IVL Generator On

Step 4 - Confirm Battery Capacity

Step 5 - Check Diagnostics

Step 6 - Initiate the Output Test

Step 7 - Confirm Output Test Result

Maintenance

6.1 Daily Maintenance

6.1.1 Charging and Testing the Internal Battery

6.1.2 Testing the IVL Generator

6.1.3 Inspecting the IVL Generator

6.1.4 Cleaning the IVL Generator

Troubleshooting

Appendix A: Electromagnetic Compatibility Guidance

Appendix C: Specifications

Shockwave IVL Specifications

General IconGeneral
Device TypeIntravascular Lithotripsy (IVL) System
ManufacturerShockwave Medical
Regulatory ApprovalsFDA approved, CE marked
Mechanism of ActionEmploys sonic pressure waves to fracture calcified plaque
Balloon MaterialSemi-compliant balloon
Sheath Compatibility6F
Energy DeliveryPulsatile sonic pressure waves
Power SourceExternal generator
CompatibilityCompatible with standard guidewires
TechnologyShockwave lithotripsy