Cautions; Product Orientation - Shockwave Medical 825D Manuel D'utilisation

device will attract the equipment with a force sufficient to cause death or serious personal injury to persons
between the equipment and the MRI device. This magnetic attraction may also damage and affect the
performance of the equipment. Burns may also occur due to heating of electrically conductive materials such as
Connector Cables and catheters. Consult the MRI manufacturer for more information.
USE ENVIRONMENT
Allow the Generator and its accessories (including Lithoplasty Catheters and Connector Cables) to adjust to room
temperature and humidity conditions for at least twenty four hours before use. See Appendix C for specified
operating conditions. Operating the equipment outside of these environmental conditions may cause equipment
malfunction or damage.
IMPROPER DEVICE PERFORMANCE HAZARDS
Using other manufacturers' cables, catheters, power adapters, or batteries may cause the device to perform
improperly and may invalidate the safety agency certifications. Use only the accessories that are specified in these
operating instructions.

2.5 CAUTIONS

CAUTIONS
GENERAL CAUTIONS
The Shockwave Medical Lithoplasty System is intended for use by a physician, or on the order of, a physician.
Prior to using the Generator, the user should be familiar with the controls and functions of the system described in
this manual.
Do not press more than one button at a time on the Generator. The Generator may not respond to either user
input.
If the shipping container has been damaged in transit or if any part of this product appears damaged, cracked,
chipped or missing, remove from use and contact your Shockwave Medical representative for repair or
replacement.
IV POLE TIP HAZARD
Observe the recommendations noted herein for mounting the Generator to an IV pole. Failure to comply with
recommendations could result in an injury to the user or patient.
CATHETER MOVEMENT HAZARD
Use caution to prevent unintentional movement of the Connector Cable and Catheter during treatment. Failure to
comply with this recommendation could result in an injury to the patient.
EQUIPMENT DAMAGE
The Generator delivers low-energy, short-duration, high-voltage pulses to the Lithoplasty Catheter through the
Connector Cable. The system is designed not to deliver pulses unless a Lithoplasty Catheter Connector is mated
with the Connector Cable. It is important not to allow the contacts or internal surfaces of unmated connectors to
be contaminated with fluids. Do not allow any connector to become contaminated by or immersed in fluids.
Failure to observe these precautions may damage the cables or catheters.
CATHETER DAMAGE
The Lithoplasty Catheters require inflation pressure using the correct mixture of contrast and saline to operate
reliably. Deliver therapy pulses only when inflated to specified pressure ranges indicated in the Lithoplasty
Catheter Instructions For Use. Failure to observe these precautions may damage the catheter balloon and could
possibly result in patient injury.

3.0 Product Orientation

Refer to the Installation and Maintenance sections for information on how to prepare the Generator for use.
The figure in 3.1 (next page) shows the front view of the Generator. All indicators are shown activated in this
view for illustration purposes only.
The table of 3.2 (next page) lists the controls and provides a brief description.
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