Shockwave IVL Operator's Manual
OPERATOR’S MANUAL
Intravascular Lithotripsy (IVL)
Generator and Connector Cable
LBL 61876 Rev E / Revision Date: March 2018
Contents
1.
Introduction ............................................................................................................................................................ 2
1.1 The IVL Generator - How Supplied .................................................................................................................................................................. 2
1.2 Required Devices and Procedure Supplies for Use with the IVL Generator .............................................................................................................. 2
1.3 Device Description ....................................................................................................................................................................................... 2
1.4 Intended Use/In dication for Use ..................................................................................................................................................................... 2
2. Safety Information .................................................................................................................................................. 2
2.1 Terms ........................................................................................................................................................................................................ 2
2.2 Contraindications ......................................................................................................................................................................................... 2
2.3 Dangers ..................................................................................................................................................................................................... 2
2.4 Warnings .................................................................................................................................................................................................... 2
2.5 Cautions ..................................................................................................................................................................................................... 3
3. Product Orientation ................................................................................................................................................. 3
3.1 IVL Generator - Front View ............................................................................................................................................................................ 3
3.2 Control and Indicator Functions ...................................................................................................................................................................... 4
3.3 Front Panel Connectors ................................................................................................................................................................................. 4
3.4 IVL Connector Cable ..................................................................................................................................................................................... 4
3.5 IVL Generator – Rear View ............................................................................................................................................................................ 4
4. Product Use and Therapy Delivery .......................................................................................................................... 5
4.1 Additional Usage Information ......................................................................................................................................................................... 6
5. Installation ............................................................................................................................................................. 7
5.1 IV Pole Mounting .......................................................................................................................................................................................... 7
5.2 Connecting to Line Power .............................................................................................................................................................................. 9
5.3 Charging th e Internal Battery ......................................................................................................................................................................... 9
5.4 Environment Conditioning.............................................................................................................................................................................. 9
5.5 Generator Inspection and Test ....................................................................................................................................................................... 9
6. Maintenance .......................................................................................................................................................... 10
6.1 Daily Maintenance .......................................................................................................................................................................................10
6.1.1 Charging and Testing the Internal Battery .............................................................................................................................................. 10
6.1.2 Testing the IVL Generator .................................................................................................................................................................... 11
6.1.3 Inspecting the IVL Generator ............................................................................................................................................................... 11
6.1.4 Cleaning the IVL Generator .................................................................................................................................................................. 11
6.2 Monthly Maintenance ...................................................................................................................................................................................11
6.3 Other Maintenance ......................................................................................................................................................................................12
6.4 Product Useful Life ......................................................................................................................................................................................12
7. Troubleshooting .................................................................................................................................................... 12
8. Appendix A: Electromagnetic Compatibility Guidance ........................................................................................... 13
9. Appendix B: Symbols ............................................................................................................................................. 14
10. Appendix C: Specifications .................................................................................................................................... 15
10.1 Appendix C1: General Specifications ..............................................................................................................................................................15
10.2 Appendix C2: Performance Specifications ........................................................................................................................................................15
NOTE: This Operator’s Manual provides inf o rm ation required for proper operation of the IVL Generator and IVL Connector Cable. Replacement IVL Connector Cables are
TEXT CONVENTIONS: Throughout these operating instructions, special text characters (for example, CAPITAL LETTERS such as ON, CATH, SYS) are used to indicate
LBL 61876 rev. E, March 2018 EN 1
available from Shockwave Medical, Inc. Refer to the applicable IVL Catheter Instructions for Use (IFU) for patient treatment information.
To Be Used Exclusively with the Shockwave Medical IVL System.
controls, connectors and lighted annunciators.
1. Introduction
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 ta rget lumen size.
DANGER
EXPLOSION HAZARD
WARNINGS
GENERAL WARNINGS
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
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 follo wing items:
The product is shipped as an assembly including the IVL Generator, IV Pole Mount and C harger Module for mounting on an IV pole, as shown below:
1.2 Required Devices and Procedure Supplies for Use with the IVL Generator
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 tre atment. This feature is designed to auto m atically set
pulse parameters unique to each catheter type such as catheter pulse life; refer to the applicable IVL Catheter Instru c tions for Use for addi tional informatio n.
1.4 Intended Use/Indication for Use
The Shockwave Medical IVL Generator and Connector Cable are intended for u se 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,
• 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.
IV Pole Mounting Bracket
Charger Module
IV Pole
• 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 (5 8 cm), and a pole diamet er of 3/4 to 1 inch (19 mm to 25 mm),
such as the I.V. League Ventilator Stat-Stand™ model 10 59 or equivalent is re quired. An IV pole that is securely affixed to the procedure bed may also be used.
warnings, prec autions, and adverse events included with each IVL Catheter prior to use of the IVL Catheter with the IVL Generator and Connector Cable.
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 res ult in serious personal i njury or death.
WARNING: Hazards or unsafe prac tices 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,
2.3 Dangers
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 disasse mble, puncture, crus h, expose to high temperatures, or incinerate the IVL Generator or bat tery.
2.4 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 prerequisi te for the proper use of this equi pment and before clinical use. The IVL Generator is only compatible with the Shockwave Medical
IVL Catheters and related access o ries.
SHOCK HAZARD
This product delivers pulses of up to 3000 volts of e le ctrical 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 ap pears 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
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.
LBL 61876 rev. E, March 2018 EN 2
CAUTIONS
GENERAL CAUTIONS
Power Status
POSSIBLE FIRE
Use care when operating this device close to oxygen source s (such as bag-valve-mask devices or ventilator tubing). Turn off gas source or move source aw ay from patient during therapy.
ELECTRICAL INTERFERENC E HAZARDS
Equipment operating in close proxi m ity may emit strong electromagnetic or radio frequency interference (RFI) which could affe ct 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, di ath e rmy
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 speci f ied 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 in st ructions.
POSSIBLE DEVICE SHUTDOWN
This device operates only from an in ternal battery source. Charge the IVL Generator battery when not in use. Available battery capacity is indicated on the IVL Generator front panel di splay
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 Generato r 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 I VL Catheters and IVL Co nnector Cables) contain ferromagnetic m aterials. 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 pers ons 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’ cable s, catheters, power adapters, or batteries may cause the device to perform improperly and may invalidate the safet y agency certifications. Use only the
accessories that are specified in these operating instructions.
2.5 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, c hipped 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 use r 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
not allow any con nector to become contaminated by or immersed in fluids. Failure to observe th ese precautions may damage the cables or catheter and then they should be replaced.
CATHETER DAMAGE
The IVL Catheters require inflat ion 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.
to allow the contacts or internal surfaces of unmated connectors to be contaminated with fluids. Do
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
LBL 61876 rev. E, March 2018 EN 3
Power On/Off
Remaining Pulse Count
Battery Capacity
Connector Door
Charger Connector (behind door)
Balloon Size
Therapy Status
Therapy On/Off
Therapy Connector
3.2 Control and Indicator Functions
CONTROL
DESCRIPTION
MORE INFO
POWER ON/OFF
Turns IVL Generator on or off.
Refer to 3.1 IVL Generator Front View
THERAPY ON/OFF
Press to activate the IVL Generator.
IVL Connector Cable and a valid IVL Catheter must be
INDICATOR
DESCRIPTION
MORE INFO
POWER STATUS Indicator
On green when IVL Generator is on.
Refer to 3.1 IVL Generator Front View
On yellow when user action is required regarding the IVL Catheter (CATH).
See Section 4 step 6.
On red when internal diagnostics have detected a problem (SYS).
See Section 7.
BATTERY CAPACITY
Display/ Charging Status
Indicates bat tery charge remaining.
See Section 4 step 2.
BATTERY CHARGING
Lightning bolt symbol appears when the Charger Module is connected and is charging
Charge IVL Generator before use. See Sections 5.2 and 5.3.
BALLOON SIZE Display
IVL Catheter Balloon Diameter and Length
When IVL Connector Cable and valid IVL Catheter
connected.
PULSE COUNT Display
Number of Pulses available.
Counts down from available Pulse Count Per Catheter during
Catheter IFU for the Max Pulse Count.
THERAPY STATUS
Indicator
On green when the device is ready to deliver therapy. Flashes to indicate therapy is
in process. On yellow when therapy is paused or deactivated.
See Section 4, Steps 5 – 9.
FEATURE
DESCRIPTION
MORE INFO
CONNECTOR DOOR
Slide right to connect charger.
Slide left to connect IVL Connector Cable.
See Section 4,
Step 4.
CHARGER CONNECTOR
Used to connect to charger module.
See Section 5.3
THERAPY CONNECTOR
Used to connect to IVL Connector Cable (the Connector Cable connects the IVL
Generator to the IVL Catheter).
See Section 4
Step 4.
Catheter Connector
connected to activate.
Indicator
the battery from mains power.
treatment as each pulse is delivered. Refer to applicable IVL
3.3 Front Panel Connectors
3.4 IVL Connector Cable
Pressing and holding the THERAPY CONTROL on the IVL Connector Cable initiates therapy delivery. The IVL Generator must first be activated (THERAPY STATUS indicators on
IVL Generator front panel and CATHETER CONNECTOR will be green). Refer to Section 4.0, Step 8 for more information.
Therapy Control
Therapy Status
3.5 IVL Generator – Rear View
There are no controls or indicators on the rear of the IVL Generator. Refer to Appendix B for more information regarding the symbols used.
LBL 61876 rev. E, March 2018 EN 4
Step
Picture or additional info if app lic ab le
Slide CONNECTOR DOOR to left to reveal the
4. Product Use and Therapy Delivery
Before use read all sections of this operator’s manual and familiarize yourself with all controls, display s and connector features. Charge the IVL Generator before use (see
Sections 5.2, 5.3). Also refer to the IFU provided with the IVL Catheter for additional information before use. Not all clinical procedures will fol low the sequence below. The
following steps serve as a guide for use of the IVL Generator in clinical applications.
Step 1 – Turn the Generator On
Momentarily depress the POWER ON/OFF button. All indicators on the IVL Generator will come on briefly as a test. The THERAPY STATUS
indicator will come on yellow and green during this test. The POWER STATUS indictor will continue to be on green.
Step 2 – Confirm Battery Capacity
With the Generator powered on, the BATTERY CAPACITY will be shown in the right side of the display. The battery symbol should be at least
partially fi lled as shown.
If the battery symbol is empty, additional charging of the battery is recommended before use because there may not be an adequate charge to
complete a patient treatment.
Step 3 – Check Diagnostics
Confirm that the display is as pictu red with no error messages displayed. If an error message is displayed, refer to Troubleshooting, Section
7.0.
Normal display with no errors shown to the right.
If a yellow light is displayed, refer to Troubleshooting, Section 7.0.
If any error messages come on during use, refer to Troub l esho oting, Section 7.0.
Error Condition – Catheter error sh own to the right.
Step 4 – Connect IVL Connector Cable
Disconnect the Charger Module from the CHARGER CONNECTOR if it is connected.
Slide the CONNECTOR DOOR fully to the left, revealing the THERAPY CONNECTOR as shown.
Connect the GENERATOR CONNECTOR end of the Connector Cable to the THERAPY CONNECTOR. Orient the connector and gently push in.
The connector is magnetic and will engage as the magnet gets close. Push gently to confirm connector is fully engaged.
Step 5 – Prepare IVL Catheter for Use
Prepare the catheter for use following the instructions in the IVL Catheter IFU. Use a sterile sleeve to cover the distal end of the IVL Connector
Cable. Protect the connector from contamination by fluids.
THERAPY CONNECTOR
THERAPY CONNECTOR:
N/A
Step 6 – Connect IVL Catheter
Take care not to c o ntaminate eithe r c onnector end with fluids or other forei gn matter during this procedure prior to mating.
Connect the IVL Catheter to the CATHETER CONNECTOR end of the IVL Connector Cable using the same method outlined in step 4.
NOTE: Ensure that the sterile sleeve also covers the CATHETER CONNECTOR.
The THERAPY STATUS indicator on the IVL Generator front panel and the CATHETER CONNECTOR will be yellow, indicating that the IVL
Generator is ready to activate.
The IVL Catheter balloon dimensions will appear in the BALLOON SIZE display. The total number of available pulses for the selected IVL
catheter will appear in the PULSE COUNT field.
Step 7 – Position the IVL Catheter
Following conventional angioplasty catheter technique, introduce and position the IVL Catheter as desired. Use caution to prevent unintentional
movement of the IVL Connector Cable and IVL Catheter during treatment.
Step 8 – Activate the IVL Generator
Inflate the IVL Catheter and verify pressure per the instructions indicated in the IVL Catheter IFU. Press the THERAPY ON/OFF button once.
The THERAPY STATUS indicator on the IVL Generator front panel and on the CATHETER CONNECTOR will now be green, indicating that the IVL
Generator is now ready to deliver therapy. To deactivate the IVL Generator at any time, simply press the IVL Generator THERAPY ON/OFF
button again and verify that the THERAPY STATUS indicator light is yellow.
LBL 61876 rev. E, March 2018 EN 5
(Refer to the IVL Catheter IFU)
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