Introduction; The Generator - How Supplied; Required Devices And Procedure Supplies For Use With The Generator; Device Description - Shockwave Medical 825D Manuel D'utilisation

1.0 Introduction

The Shockwave Medical Lithoplasty System is comprised of the Shockwave Medical Lithoplasty Generator
(Generator), Connector Cable and Shockwave Medical Lithoplasty Catheters (Lithoplasty Catheter(s)). The
Generator and Connector Cable are to be used exclusively with the Lithoplasty Catheters. The Lithoplasty
Catheter balloons incorporate unique energy emitting transducers unlike standard angioplasty catheters. This
technology has been designed to achieve clinically significant dilation at much lower balloon pressures.

1.1 The Generator - How Supplied

The Generator is provided non-sterile and is reusable.
The Generator is shipped with the following items:

IV Pole Mounts for Generator and Charger

Charger Module

1 ea* Connector Cable (See Section 3.4)

AC Mains Cable

Operator's Manual
* Additional Connector Cables can be ordered separately.
The product is shipped as an assembly including the Generator, IV Pole Mount and Charger Module for
mounting on an IV pole, as shown below:
Generator

1.2 Required Devices and Procedure Supplies for Use with the Generator


Lithoplasty Catheter

Sterile Sleeve for 1.52 m Connector Cable

One IV pole with five casters located in a circular pattern with a diameter of at least 23 inches (58 cm),
and a pole diameter of 3/4 to 1 inch (19 mm to 25 mm), such as the I.V. League Ventilator Stat-Stand™
model 1059 or equivalent is required. An IV pole that is securely affixed to the procedure bed may
also be used.

1.3 Device Description

The Generator and Connector Cable are used with an appropriate Lithoplasty Catheter to deliver localized,
lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The Generator, Connector Cable and
Lithoplasty Catheters are designed to exchange data during patient treatment. This feature is designed to
LBL 60780 rev. B
IV Pole Mounting
Bracket
Charger
Module
EN
IV
Pole
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