Intravascular Lithotripsy (IVL) Connector Cable
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6. Use only parts and accessories specified in the IVL Generator andConnector Cable Operator Manual. Using a connector cable not specified foruse may result in increased emissions and/or decreased immunity fromelectromagnetic or radio frequency interference (RFI) which could affect theperformance of this product or of equipment in close proximity.
7. Allow the IVL Connector Cable to adjust to room temperature and humidity
conditions for at least twenty four hours before use. Operating theequipment outside of these environmental conditions (10° – 35°C) may
cause equipment malfunction or damage.

Intravascular Lithotripsy (IVL) Connector Cable
Instructions for Use (IFU)
For use with Shockwave Medical IVL Generator and IVL Catheters
Contents: IVL Connector Cable (1)How Supplied
The Shockwave Medical IVL Connector Cable is provided non-sterile andreusable. The IVL Connector Cable is intended for use with a sterile sleeve(not supplied). Carefully inspect all packaging for damage or defects prior touse.

Caution: Refer to IVL Generator and Connector Cable Operator’s Manual forpreparation, operation, warnings and precautions, and maintenance of thisdevice.
Cleaning the IVL Connector Cable
Dirt and extraneous matter may be removed from the IVL Connector Cable
using a soft cotton cloth or a lint free wipe. If needed, use only isopropyl
alcohol sparingly as a cleaning agent.
Do not allow any fluids to penetrate the exterior surfaces of the device. Allowequipment to dry thoroughly before testing or use.
Clean connector areas carefully. Do not attempt to clean interior surfaces ofconnectors or connector contacts. In the event an IVL Connector Cable has
become contaminated or malfunctions, remove this cable from use and contact
Shockwave Medical for a replacement.
Shockwave Medical recommends replacement of IVL Connector Cables every
three years to reduce the possibility of failure during patient use. In the event
IVL Connector Cable connectors have become contaminated or the IVL
Connector Cable malfunctions, remove this cable from use and contact
Shockwave Medical for a replacement.

Intended Use
The IVL Connector Cable is intended for use with the Shockwave Medical IVL
Generator and IVL Catheters.
Device Description
The IVL Connector Cable is a remote actuator that connects the IVL Generator
to the IVL Catheter and is used to activate lithotripsy energy within the balloon.

Figure 1: IVL Connector Cable
Warnings
1. DO NOT sterilize the IVL Connector Cable as this can potentially result incompromised device performance.
2. Inspect product and packaging prior to use. Do not use the device if it or thepackaging has been damaged.
3. Always insert the IVL Connector Cable into a Sterile Sleeve before
connecting the sterile IVL Catheter.
4. Care should be taken to secure the IVL Connector Cable to prevent
unintentional movement during treatment. Failure to comply could result ininjury to the patient.
5. The IVL Generator delivers low energy, short duration, high voltage pulses
to the IVL Catheter through the IVL Connector Cable. The system isdesigned not to deliver pulses unless an IVL Catheter is mated with the IVLConnector Cable Catheter Connector. It is important not to allow thecontacts or internal surfaces of unmated connectors to be contaminated withfluids. Do not allow any connector to become contaminated by or immersed
in fluids. Failure to observe these precautions may damage the IVLConnector Cables or IVL Catheters.
6. The IVL Connector Cable contains ferromagnetic materials and should not
be used in the presence of the high magnetic field created by a Magnetic
Resonance Imaging (MRI) device.
7. Precaution should be taken when handling device after exposure to patient
blood. Used product is potentially biohazardous and should be cleaned anddisinfected as described below or in accordance with hospital protocol.
8. Inspect the IVL Connector Cable to confirm that there are no damaged, split
or cracked materials and electrical contacts are free of extraneous matter.

Return of Devices
If any portion of the Shockwave Medical IVL System fails prior to or during aprocedure, discontinue use and notify Shockwave Medical atcomplaints@shockwavemedical.com. The device should be placed in abiohazard container with a Returned Material Authorization (RMA) number
assigned by Shockwave Medical.
Patents: www.shockwavemedical.com/patents
Shockwave Medical, Inc.
5403 Betsy Ross Drive
Santa Clara, CA 95054, USA
www.shockwavemedical.com

ICON (LR) Limited
South County Business Park
Leopardstown
Dublin 18
D18 X5R3
IrelandPrecautions
1. For preparation, operation, warnings and precautions, and maintenance of
the IVL Connector Cable please refer to the IVL Generator Operator’sManual.
2. Do not immerse any portion of the IVL Connector Cable in water or otherfluids.
3. Do not clean with solvents or flammable agents as this might cause harm tothe equipment and/or the user.
4. If the IVL Connector Cable is damaged, remove and use a new IVL
Connector Cable.
5. Store the IVL Connector Cable in a dry place with temperature
between -20°C and 65°C. Storage of the device in extreme conditions may
affect device performance and lead to patient injury.
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Symbol

LBL 65311-A, 2021-09

SymbolDefinition
Caution, read instructions for use. Refer to this IFU andthe Operator’s Manual for the Shockwave MedicalGenerator for additional information

Definition
Contains 1 unit (Contents: 1)

Manufacturer

Non-sterile

Date of manufacture

Humidity Limitation

Waste from Electrical and Electronic Equipment Directive
The IVL Generator and IVL Connector Cable should not be
disposed of in the normal waste stream and should be sent
to separate collection facilities for recovery and recycling.

Temperature limitation

Keep dry

Caution: Federal (USA) Law restricts this device to sale byor on the order of a physician.

Authorized Representative in the European Community

Conformité Européenne

Protect from heat and radioactive sources

PATPatents. Refer to www.shockwavemedical.com/patents

Batch code

IVL

Intravascular Lithotripsy

Catalogue number

Indicates a carrier that contains Unique Device Identifier information.

Consult instructions for use

An indication that the device is a medical device.

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PN 65313 Rev A