Safety Information; Terms; Contraindications; Dangers - Shockwave Medical Lithoplasty 825D Manual Del Operador

automatically set pulse parameters unique to each catheter type such as catheter pulse life; refer to the
applicable Lithoplasty Catheter Instructions for Use for additional information.
1.4 Intended Use/Indication for Use
The Shockwave Medical Lithoplasty Generator and Connector Cable are intended for use with Shockwave
Medical Lithoplasty Catheters only.
NOTE: Refer to the individual Lithoplasty Catheter Instructions for Use for catheter compatibility with the
Shockwave Medical Lithoplasty Generator Model 825D. It is also important to carefully review the specific
indications, contraindications, warnings, precautions, and adverse events included with each Lithoplasty
Catheter prior to use of the Lithoplasty Catheter with the Generator and Connector Cable.
CAUTION: The Shockwave Medical Lithoplasty System is intended to be used by trained medical personnel in
a catheterization lab within the environmental ranges specified in Appendix C. This device should only be used
following an arteriogram (or CT or MRI) of the vascular system and confirmation of appropriate target lumen
size.

2.0 Safety Information

2.1 Terms

The following terms are used either in these operating instructions or on the Generator:
Danger: Immediate hazards that will result in serious personal injury or death.
Warning: Hazards or unsafe practices that may result in serious personal injury or death.
Caution: Hazards or unsafe practices that may result in minor personal injury, product damage, or
property damage.

2.2 Contraindications

There are no specific contraindications for use of the Generator and Connector Cable. However, users should
read and understand the specific indications, contraindications, warnings, and precautions included with any
Lithoplasty Catheter used in conjunction with the Generator and Connector Cable.
NOTE: The contraindications listed in the catheter Instructions For Use also apply to the use of the Lithoplasty
Generator and Connector Cable. Carefully review the specific indications, contraindications, warnings,
precautions, and adverse events included with each Lithoplasty Catheter, prior to use of the Lithoplasty
Catheter with the Generator and Connector Cable.

2.3 Dangers

DANGER
EXPLOSION HAZARD
This system generates small electrical sparks during normal operation. Do not use this product in the presence of
flammable gases or anesthetics.
FIRE HAZARD
The Generator contains a rechargeable lithium ion battery. Do not disassemble, puncture, crush, expose to high
temperatures, or incinerate the Generator or battery.
2.4 Warnings
WARNINGS

GENERAL WARNINGS

Do not operate the Shockwave Medical Lithoplasty System until you have read both the Operator's Manual and the
Instructions for Use provided with the Lithoplasty Catheter.
An understanding of the features, functions, indicators and connectors of Generator is a prerequisite for the
proper use of this equipment. Training is required before clinical use.
The Generator is only compatible with the Shockwave Medical Lithoplasty Catheters and related accessories.
LBL 60780 rev. B
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