LBL 61876 rev. E, March 2018
EN
3
POSSIBLE FIRE
Use care when operating this device close to oxygen sources (such as bag-valve-mask devices or ventilator tubing). Turn off gas source or move source away from patient during therapy.
ELECTRICAL INTERFERENCE HAZARDS
Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference (RFI) which could affect the performance of this device. If use of equipment in close
proximity is necessary, observe the device to verify normal operation in the configuration in which the device will be used. Do not operate the IVL Generator near cauterizers, diathermy
equipment, or other portable and mobile RF communications equipment. Refer to Appendix A for recommended distances of equipment. Contact your Shockwave Medical representative if
assistance is required.
POSSIBLE ELECTRICAL INTERFERENCE
Using cables, emitters, or accessories not specified for use with this product may result in increased emissions and/or decreased immunity from electromagnetic or radio frequency
interference (RFI) which could affect the performance of this product or of equipment in close proximity. Use only parts and accessories specified in these operating instructions.
POSSIBLE DEVICE SHUTDOWN
This device operates only from an internal battery source. Charge the IVL Generator battery when not in use. Available battery capacity is indicated on the IVL Generator front panel display
as a battery symbol that is filled in solid proportionate to charge status. A lightning bolt symbol is displayed inside the battery symbol during charging. The IVL Generator may shut down
without warning if the IVL Generator is operated while the battery symbol is empty (no portion filled in). Remove the IVL Generator from use and contact your Shockwave Medical
representative in the event the displayed battery symbol is frequently empty or if the battery symbol is not full after twelve hours of charging.
SAFETY RISK AND POSSIBLE EQUIPMENT DAMAGE / POSSIBLE INJURY OR SKIN BURNS
The IVL Generator and its accessories (including IVL Catheters and IVL Connector Cables) contain ferromagnetic materials. As with all ferromagnetic equipment, these products must not be
used in the presence of the high magnetic field created by a Magnetic Resonance Imaging (MRI) device. The high magnetic field created by an MRI 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 IVL Connector Cables and IVL Catheters. Consult the MRI manufacturer for more information.
USE ENVIRONMENT
Allow the IVL Generator and its accessories (including IVL Catheters and IVL 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 IVL System is intended for use by a physician, or on the order of, a physician. Prior to using the IVL 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 IVL Generator. The IVL 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.
IVL POLE TIP HAZARD
Observe the recommendations noted herein for mounting the IVL 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 IVL Connector Cable and IVL Catheter during treatment. Failure to comply with this recommendation could result in an injury to
the patient.
EQUIPMENT DAMAGE
The IVL Generator delivers low-energy, short-duration, high-voltage pulses to the IVL Catheter through the IVL Connector Cable. The system is designed not to deliver pulses unless an
IVL Catheter Connector is mated with the IVL 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 catheter and then they should be replaced.
CATHETER DAMAGE
The IVL Catheters require inflation pressure using the correct mixture of 50% contrast and 50% saline to operate reliably. Deliver therapy pulses only when the balloon contains fluid.
Only inflate the balloon to the specified pressure ranges indicated in the IVL Catheter Instructions For Use. Failure to observe these precautions may damage the IVL Catheter balloon
and could possibly result in patient injury.
3.
Product Orientation
Refer to the Installation and Maintenance sections for information on how to prepare the IVL Generator for use. The figure in 3.1 (next page) shows the front view of the IVL
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.
3.1
IVL Generator - Front View
Power Status
Power On/Off
Remaining Pulse Count
Battery Capacity
Connector Door
Charger Connector (behind door)
Balloon Size
Therapy Status
Therapy On/Off
Therapy Connector
