CORONARY IVL PROCEDURAL TRAINING - STEP-BY-STEP CASE GUIDE - Shockwave ...
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CORONARY IVL PROCEDURAL TRAINING STEP-BY-STEP CASE GUIDE
SHOCKWAVE MEDICAL
USER GUIDE
(( STEP 1 - Prepare Generator1 ))
Coronary IVL System Set-up
1. Start 2. Confirm 3. Detach 4. Slide 5. Attach
• Press Power Button to • Confirm Battery capacity • Detach the Charger • Slide the Connector • Insert the proximal end
turn Generator ON via battery symbol Cable from the Door to the left of the Connector Cable
Generator to the Generator
• The ON indicator will turn • If the battery symbol
green is empty, additional
Note: If Power Button light turns yellow, please
charging of the battery is
refer to the Generator Manual recommended before
use
1
Refer to the Generator Manual for full details and Warnings and Precautions.
2 SPL 64426 Rev B – Coronary IVL Step-by-Step Setup. Shockwave Medical, Inc. 2021.
SHOCKWAVE MEDICAL
USER GUIDE
(( STEP 2 - Prepare and Insert Catheter1 ))
Coronary IVL System Set-up
Size: Select catheter using 1:1 (catheter to intended stent size) sizing protocol
Diameter Length Pulses Guidewire Guide Cath Length Tip Profile Crossing Profile
2.5-3.0- 3.5-4.0mm 12mm 80 0.014in 6F 138cm 0.023in 0.044-0.047in
Lithotripsy delivery 4 atm
Nominal pressure 6 atm
Rated Burst Pressure 10 atm
1
Refer to the Catheter IFU for full details and Warnings and Precautions.
3 SPL 64426 Rev B – Coronary IVL Step-by-Step Setup. Shockwave Medical, Inc. 2021.
SHOCKWAVE MEDICAL
USER GUIDE
(( STEP 2 - Prepare and Insert Catheter1 ))
Coronary IVL System Set-up
vv v
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1. Remove 2. Prepare 3. Connect
• Remove Catheter from sterile packaging • Prepare Balloon using standard technique • Feed Connector Cable through sterile sleeve
• Remove Catheter from tray and loop • Utilize 1:1 saline/contrast mixture during (Note: image not shown)
preparation and use
• Warning: Do not use the device if the • Connect proximal end of Catheter to distal
protective sheath or shipping mandrel are • Ensure vacuum is pulled at least three times end of Connector Cable
difficult to remove or cannot be removed.
• Remove protective sheath from tip
1
Refer to the Catheter IFU for full details and Warnings and Precautions.
4 SPL 64426 Rev B – Coronary IVL Step-by-Step Setup. Shockwave Medical, Inc. 2021.
SHOCKWAVE MEDICAL
USER GUIDE
(( STEP 2 - Prepare and Insert Catheter1 ))
Coronary IVL System Set-up
Advance and Position:
Advance the Catheter over .014” Guidewire to the
treatment site and position the Catheter using standard
technique
Distal Marker
Proximal Marker
1
Refer to the Catheter IFU for full details and Warnings and Precautions.
5 SPL 64426 Rev B – Coronary IVL Step-by-Step Setup. Shockwave Medical, Inc. 2021.
SHOCKWAVE MEDICAL
USER GUIDE
Coronary IVL System Set-up (( STEP 3 - Administer Treatment1,2 ))
1. Inflate 2. Activate 3. Deliver
• Inflate to 4 atm • Press “Activate” button to arm the • Press and hold the button on Connector Cable for
Caution: Care must be taken to avoid applying Generator; light will turn from orange to 10 seconds to deliver energy
lithotripsy therapy, i.e. pressing the therapy green to indicate “active state” to deliver
button of the IVL Connector Cable while
lithotripsy balloon is dry and/or un-inflated, as treatment • Audible clicks and flashing LED will confirm therapy
this may damage the balloon. is being delivered
• To deactivate the Generator at any time,
press this button again • Do not exceed 80 pulses in a single segment
Note: Lithotripsy should not be delivered if the balloon is inflated to >4 atm as there is no
Note: If the Therapy Button light turns yellow, please refer to the
increase in sonic output and higher pressure during treatment can increase the risk that
Generator Manual the balloon loses pressure.
Note: Monitor catheter pressure and modulate to maintain at 4 atm as needed
1Refer to the Generator Manual for full details and Warnings and Precautions.
2Refer to the Catheter IFU for full details and Warnings and Precautions.
6 SPL 64426 Rev B – Coronary IVL Step-by-Step Setup. Shockwave Medical, Inc. 2021.
SHOCKWAVE MEDICAL
USER GUIDE
Coronary IVL System Set-up (( STEP 3 - Administer Treatment1,2 ))
4. Expand 5. Deflate
• Expand to reference vessel diameter and • Following first cycle, deflate balloon
maintain per standard practice Note: The IVL Generator is programmed to force a minimum pause time of 10 seconds following every 10 pulses
delivered.
• Repeat treatment until desired luminal gain is achieved
Note: When repositioning the catheter to treat another segment of the same lesion overlap by at least 2mm
1Refer
Caution: IVL Catheter once pulled out of the body should not be reinserted for additional inflation or lithotripsy
to the Generator Manual for full details and Warnings and Precautions. treatments. Balloon can be damaged in the process.
2Refer to the Catheter IFU for full details and Warnings and Precautions.
7 SPL 64426 Rev B – Coronary IVL Step-by-Step Setup. Shockwave Medical, Inc. 2021.
SHOCKWAVE MEDICAL
USER GUIDE
Coronary IVL System Setup (( STEP 3 - Administer Treatment1,2 ))
Balloon working length of 12 mm
from inner edge of marker bands
12 mm
Working Lengths
2 mm 6mm between emitters and
4 mm 6mm
4mm/2mm between emitters and
marker bands
Acoustic pressure declines ~3mm
away from the emitter*
Energy Profile 12 mm
Smooth energy profile over center
12mm of balloon
2 mm
Optimized Overlap
2 mm overlap optimizes energy profile
1Refer to the Generator Manual for full details and Warnings and Precautions.
2Refer to the Catheter IFU for full details and Warnings and Precautions.
*Data on file.
8 SPL 64426 Rev B – Coronary IVL Step-by-Step Setup. Shockwave Medical, Inc. 2021.
Generator Lights Cheat Sheet
Normal Normal Normal Catheter System Passed Self
Power On Ready/Standby Ready Error Error Test
9 SPL 64426 Rev B – Coronary IVL Step-by-Step Setup. Shockwave Medical, Inc. 2021.
Generator Troubleshooting: Catheter Errors
Catheter Errors
Power button illuminates amber and an error message is displayed on the screen
What it means Recommended Actions
Error 80 The generator was unable to mark the catheter for beginning of life. • Turn the generator power OFF
Possible causes are
Catheter beginning • Loose connection between the generator and catheter. • Check catheter and connector cable connection
of life unsuccessful. • Defective Connector cable • Make certain that the sterile sleeve is not
• Defective Catheter
interfering with the catheter and cable
Generator was unable to identify the catheter type. connection.
Error 81
Catheter Possible causes are • Make certain that the connection to the
• Loose connection between the generator and catheter.
identification • Defective Connector cable
generator is secure and that the generator
unsuccessful • Defective Catheter connector door is not interfering with the
cable connector.
Error 88 The generator was unable to measure pulse energy delivery to the • Purge and re-prep the balloon
catheter within allowed time limit.
Pulse delivery Possible causes are • Turn the generator power ON
timeout. • Gas bubbles in the balloon • Press the generator front panel therapy button
• Loose connection between the generator and catheter.
• Defective Connector cable when ready
• Defective Catheter • Resume pulse delivery.
• If the error condition persists, replace the catheter.
Error 89 All pulses have been used
• This catheter was previously used more than 6 hours previous
Catheter end of life • This catheter was previously connected to another generator
has been reached • Bad connection at generator or catheter ends of the connector cable.
(EOL).
10 SPL 64426 Rev B – Coronary IVL Step-by-Step Setup. Shockwave Medical, Inc. 2021.Generator Troubleshooting: System Errors
System Errors
Power button illuminates red and an error message is displayed on the screen
What it means Recommended Actions
Error 90 and 93 The generator has detected an error. • Internal generator errors are generally not recoverable.
Internal Generator Possible causes are: To attempt recovery:
Error • Voltage out of range • Turn off for a few seconds, then turn on and run self-
test mode.
Self Test Mode:
• Self-Test Mode
• Plug the charger into the generator and an AC outlet.
• Make certain that the battery symbol indicates charging (lightning bolt).
• Turn the generator power ON (momentarily press the power button)
• Once the generator finishes the power on sequence, press and hold the
THERAPY button until the THERAPY button logo lights GREEN
(approximately 3 seconds), then release the THERAPY button.
• The self-test will complete in approximately 20 seconds.
• PASS is indicated by four audible beeps and GREEN POWER button logo.
• FAIL is indicated by three audible beeps and RED POWER button logo.
11 SPL 64426 Rev B – Coronary IVL Step-by-Step Setup. Shockwave Medical, Inc. 2021.Important Safety Information
Rx only
Indications for Use— The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation
of severely calcified, stenotic de novo coronary arteries prior to stenting.
Contraindications—The Shockwave C2 Coronary IVL System is contraindicated for the following: This device is not intended for stent delivery. This device is not intended for use in carotid or
cerebrovascular arteries.
Warnings—Use the IVL Generator in accordance with recommended settings as stated in the Operator’s Manual. The risk of a dissection or perforation is increased in severely calcified
lesions undergoing percutaneous treatment, including IVL. Appropriate provisional interventions should be readily available. Balloon loss of pressure was associated with a numerical increase in
dissection which was not statistically significant and was not associated with MACE. Analysis indicates calcium length is a predictor of dissection and balloon loss of pressure. IVL generates
mechanical pulses which may cause atrial or ventricular capture in bradycardic patients. In patients with implantable pacemakers and defibrillators, the asynchronous capture may interact with
the sensing capabilities. Monitoring of the electrocardiographic rhythm and continuous arterial pressure during IVL treatment is required. In the event of clinically significant hemodynamic
effects, temporarily cease delivery of IVL therapy.
Precautions— Only to be used by physicians trained in angiography and intravascular coronary procedures. Use only the recommended balloon inflation medium. Hydrophilic coating to be wet
only with normal saline or water and care must be taken with sharp objects to avoid damage to the hydrophilic coating. Appropriate anticoagulant therapy should be administered by the
physician. Precaution should be taken when treating patients with previous stenting within 5mm of target lesion.
Potential adverse effects consistent with standard based cardiac interventions include– Abrupt vessel closure - Allergic reaction to contrast medium, anticoagulant and/or antithrombotic
therapy-Aneurysm-Arrhythmia-Arteriovenous fistula-Bleeding complications-Cardiac tamponade or pericardial effusion-Cardiopulmonary arrest-Cerebrovascular accident (CVA)-Coronary
artery/vessel occlusion, perforation, rupture or dissection-Coronary artery spasm-Death-Emboli (air, tissue, thrombus or atherosclerotic emboli)-Emergency or non-emergency coronary artery
bypass surgery-Emergency or non-emergency percutaneous coronary intervention-Entry site complications-Fracture of the guide wire or failure/malfunction of any component of the device that
may or may not lead to device embolism, dissection, serious injury or surgical intervention-Hematoma at the vascular access site(s)-Hemorrhage-Hypertension/Hypotension-
Infection/sepsis/fever-Myocardial Infarction-Myocardial Ischemia or unstable angina-Pain-Peripheral Ischemia-Pseudoaneurysm-Renal failure/insufficiency-Restenosis of the treated coronary
artery leading to revascularization-Shock/pulmonary edema-Slow flow, no reflow, or abrupt closure of coronary artery-Stroke-Thrombus-Vessel closure, abrupt-Vessel injury requiring surgical
repair-Vessel dissection, perforation, rupture, or spasm
Risks identified as related to the device and its use: Allergic/immunologic reaction to the catheter material(s) or coating-Device malfunction, failure, or balloon loss of pressure leading to
device embolism, dissection, serious injury or surgical intervention-Atrial or ventricular extrasystole-Atrial or ventricular capture
Prior to use, please reference the Instructions for Use for more information on warnings, precautions and adverse events. www.shockwavemedical.com/IFU
12 SPL 64426 Rev B – Coronary IVL Step-by-Step Setup. Shockwave Medical, Inc. 2021.You can also read
