LBL 61876 rev. E, March 2018
EN
2
1.
Introduction
The Shockwave Medical Intravascular Lithotripsy (IVL) System is comprised of the IVL Generator, IVL Connector Cable and IVL Catheters. The IVL Generator and Connector
Cable are to be used exclusively with the IVL Catheters. The IVL Catheter incorporates unique energy emitting transducers inside the distal balloon. This technology uses
lithotripsy to achieve clinically significant dilation at low balloon pressures.
1.1
The IVL Generator - How Supplied
The IVL Generator is provided non-sterile and is reusable. The IVL Generator is shipped with the following items:
•
IV Pole Mounts for IVL Generator and Charger
•
Charger Module
•
1 ea* IVL Connector Cable (See Section 3.4)
•
AC Mains Cable
•
Operator’s Manual
* Additional IVL Connector Cables can be ordered separately.
The product is shipped as an assembly including the IVL Generator, IV Pole Mount and Charger Module for mounting on an IV pole, as shown below:
1.2
Required Devices and Procedure Supplies for Use with the IVL Generator
•
Shockwave Medical IVL Catheter
•
Sterile Sleeve, 1.52 m long for IVL 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 IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic
arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment. This feature is designed to automatically set
pulse parameters unique to each catheter type such as catheter pulse life; refer to the applicable IVL Catheter Instructions for Use for additional information.
1.4
Intended Use/Indication for Use
The Shockwave Medical IVL Generator and Connector Cable are intended for use with Shockwave Medical IVL Catheters only.
NOTE:
Refer to the individual Shockwave Medical IVL Catheter Instructions for Use. It is important to carefully review the specific indications, contraindications,
warnings, precautions, and adverse events included with each IVL Catheter prior to use of the IVL Catheter with the IVL Generator and Connector Cable.
CAUTION
The IVL System is intended to be used by experienced 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.
Safety Information
2.1
Terms
The following terms are used either in these operating instructions or on the IVL 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 IVL Generator and Connector Cable. However, users should read and understand the specific indications,
contraindications, warnings, and precautions included with the applicable Shockwave Medical IVL Catheter Instructions For Use (IFU).
NOTE:
The contraindications listed in the IVL Catheter IFU also apply to the use of the IVL Generator and Connector Cable. Carefully review the specific indications,
contraindications, warnings, precautions, and adverse events included with each IVL Catheter, prior to use of the IVL Catheter with the IVL 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 IVL Generator contains a rechargeable lithium ion battery. Do not disassemble, puncture, crush, expose to high temperatures, or incinerate the IVL Generator or battery.
2.4
Warnings
WARNINGS
GENERAL WARNINGS
Do not operate the IVL System until you have read both the Operator’s Manual and the Instructions for Use provided with the IVL Catheter. An understanding of the features, functions,
indicators and connectors of IVL Generator is a prerequisite for the proper use of this equipment and before clinical use. The IVL Generator is only compatible with the Shockwave Medical
IVL Catheters and related accessories.
SHOCK HAZARD
This product delivers pulses of up to 3000 volts of electrical energy. Unless properly used as described in these operating instructions, this electrical energy may cause serious injury. To
avoid the risk of electrical shock, this equipment must only be connected to a grounded electrical outlet (electrical supply mains with protective earth.) Use with a hospital grade receptacle.
Grounding reliability can only be achieved when connected to an equivalent receptacle marked “hospital use” or “hospital grade”. Only use the Charger Module provided with the IVL
Generator to avoid shock.
SHOCK HAZARD
Do not attempt to service the system. It contains no operator serviceable components and dangerous high voltages may be present. No user modification or servicing of this equipment is
allowed. If any part of this product appears damaged, remove from use and contact your Shockwave Medical representative for repair or replacement.
SHOCK OR FIRE HAZARD
Do not immerse any portion of the IVL Generator in water or other fluids. Do not immerse IVL Connector Cables in water or other fluids. Avoid spilling any fluids on the IVL Generator.
Spilled liquids may cause the IVL Generator to perform inaccurately or malfunction. Do not clean with solvents or flammable agents as this may cause damage to the IVL Generator and
possibly cause harm to the user. Do not autoclave or sterilize the IVL Generator or IVL Connector Cables as this may cause the IVL Generator or IVL Connector Cable to malfunction.
IVL Generator
IV Pole Mounting Bracket
Charger Module
IV Pole
