Operators Manual
147 Pages
Preview
Page 1
Volcano CORE Mobile ™
Precision Guided Therapy System
Operator’s Manual For use with: Volcano CORE Mobile, Precision Guided Therapy System 400-0100.01 400-0100.07 400-0100.08 Software Version 3.3.X
Complies with the Council Directive 93/42/EEC
Volcano CORE™ system product meets TUV’s safety requirements Attention: Read Operator’s Manual and Instructions For Use prior to using this device. Please contact your local Volcano representative for translated versions. This device contains mercury, dispose according to state/local laws. Do not dispose of this device or its components. Improper disposal may be harmful to the environment and human health. Dispose device per local electronic waste regulations. Manufactured by: Volcano Corporation 2870 Kilgore Road Rancho Cordova, CA 95670 USA Phone: 916.638.8008 Phone: 800.228.4728 (USA and Canada) Fax: 916.638.8112 www.volcanocorp.com Authorized European Representative: Volcano Corporation Europe BVBA/SPRL Excelsiorlaan 41 B-1930 Zaventem, Belgium Phone: +32.2.679.1076 Fax: +32.2.679.1079 © 2013 Volcano Corporation. All rights reserved. No part of this manual may be reproduced in any form without the written permission of Volcano Corporation. Revision Date: June 2013
Page 2 of 147
505-0100.16/002
Table of Contents WARRANTY ... 6 PATENTS AND TRADEMARKS ... 8 PATENTS... 8 TRADEMARKS ... 10 WARNINGS AND PRECAUTIONS ... 11 READ AND REVIEW MANUAL BEFORE OPERATION ... 11 FOR USE ONLY BY TRAINED MEDICAL PERSONNEL ... 11 SYSTEM USE CAUTIONS AND WARNINGS ... 11 PIM USE CAUTIONS AND WARNINGS ... 14 CATHETER AND WIRE USE CAUTIONS AND WARNINGS ... 14 CONTACT INFORMATION ... 15 CHAPTER 1: OVERVIEW... 17 INTRODUCTION ... 17 INDICATIONS FOR USE ... 20 CLINICAL APPLICATIONS ... 20 CONTRAINDICATIONS ... 20 POSSIBLE ADVERSE REACTIONS ... 20 CHAPTER 2: SYSTEM DESCRIPTION ... 23 SYSTEM OVERVIEW ... 23 MONITOR ... 24 CONTROL CONSOLE ... 25 JOYSTICK CONTROLLER OPTION ... 29 WORKSTATION (CENTRAL PROCESSING UNIT) ... 30 PRINTER ... 30 CONNECTOR PANEL ... 30 PATIENT INTERFACE MODULE ... 32 CATHETERS ... 33 AVAILABLE OPTIONS ... 33 CHAPTER 3: SYSTEM SETUP ... 35 OVERVIEW ... 35 INSTALLATION ... 35 TURNING SYSTEM ON... 36 IVUS SOFTWARE SETTINGS... 36 CHAPTER 4: PREPARING FOR A CASE ... 47 OVERVIEW ... 47 ENSURE SYSTEM POWER IS ON ... 47 CONNECT THE PIM ... 48 ENTER PATIENT INFORMATION ... 49 CHAPTER 5: ACQUIRING IVUS IMAGES ... 51
505-0100.16/002
Page 3 of 147
OVERVIEW ... 51 INSERT THE CATHETER ... 51 ADJUST THE IMAGE (IF DESIRED) ... 52 CHAPTER 6: RECORDING IVUS IMAGES ... 57 OVERVIEW ... 57 RECORDING A VIDEO LOOP ... 57 SAVING A FRAME ... 59 CHAPTER 7: REVIEWING IVUS IMAGES ... 61 OVERVIEW ... 61 REVIEWING SAVED FRAMES ... 62 REVIEWING VIDEO LOOPS ... 62 DISPLAY MODE ... 68 PRINTING ... 68 CHAPTER 8: MAKING MEASUREMENTS AND ANNOTATIONS ... 71 MAKING MEASUREMENTS ... 71 CHAPTER 9: USING VH IVUS (AVAILABLE ON EAGLE EYE AND VIBE CATHETERS ONLY) ... 79 OVERVIEW ... 79 ACTIVATING VH DISPLAY ... 80 USING THE VH SCREEN ... 81 USING TARGET ASSIST ... 84 CHAPTER 10: USING THE CHROMAFLO FEATURE ... 85 OVERVIEW ... 85 ACTIVATING THE CHROMAFLO FEATURE ... 85 CONTROLLING THE SENSITIVITY ... 86 SETTING THE REGION OF INTEREST ... 86 DEACTIVATING THE CHROMAFLO FEATURE ... 86 CHAPTER 11: ENDING AN IVUS CASE ... 87 OVERVIEW ... 87 ENDING A CASE... 87 DELETING A CASE ... 88 CHAPTER 12: ARCHIVING AN IVUS CASE... 89 OVERVIEW ... 89 ARCHIVING OPTIONS ... 89 ARCHIVING USING DICOM ... 91 PRINTING IMAGES ... 91 CHAPTER 13: SWITCHING MODES... 93 OVERVIEW ... 93 ENTERING PATIENT INFORMATION ... 93 SWITCHING MODES ... 93 CHAPTER 14: RETRIEVING AND DELETING AN IVUS CASE ... 95 OVERVIEW ... 95 Page 4 of 147
505-0100.16/002
RETRIEVING A CASE ... 95 DELETING A CASE ... 96 REMOVING POWER FROM SYSTEM ... 96 CHAPTER 15: IMAGE EXPORT OPTION ... 97 CHAPTER 16: TROUBLESHOOTING ... 99 MESSAGE ALERTS ... 99 POTENTIAL IMAGING ARTIFACTS ... 104 EU BATTERY DIRECTIVE, 2006/66/EC REQUIREMENTS... 109 CHAPTER 17: MAINTENANCE... 111 SERVICE ... 111 MAINTENANCE FREQUENCY ... 111 USER-PERFORMED MAINTENANCE ... 112 VOLCANO-CERTIFIED MAINTENANCE ... 115 CHAPTER 18: TECHNICAL SPECIFICATIONS ... 117 IMAGING CATHETERS ... 117 VIDEO... 118 CORE MOBILE DIMENSIONS AND WEIGHTS ... 119 POWER ... 119 RECORDING DEVICES ... 121 CLASSIFICATIONS... 121 EMC STATEMENT ... 121 ELECTRICAL SAFETY ... 122 ENVIRONMENTAL CONDITIONS ... 122 DICOM IMAGE STORAGE ... 122 ESSENTIAL PERFORMANCE, CATHETER OPERATING TEMPERATURES ... 123 ESSENTIAL PERFORMANCE, SYSTEM ... 123 CATHETER ACOUSTIC OUTPUTS ... 124 MEASUREMENT ACCURACY ... 127 ACCESSORIES AND REPLACEMENT PARTS ... 128 STANDARDS AND REGULATIONS ... 129 SYMBOLS ... 136 GLOSSARY ... 137 APPENDIX A: VH MEASUREMENTS ... 138 FRAME RESULTS ... 138 SEGMENT RESULTS ... 138 APPENDIX B: TECHNOLOGY SUMMARY ... 140 METHODS ... 140 ACCURACY ANALYSIS ... 141 RESULTS ... 142 APPENDIX C: CONFIGURING DICOM ... 143 WORKLIST SERVERS CONFIGURATION ... 146
505-0100.16/002
Page 5 of 147
Warranty NOTICE: Manufacturer’s Specifications and Policies Subject to Change. Volcano Corporation reserves the right to make changes in the products described in this manual in order to improve design or performance. Reproduction or distribution of any portion of this manual without the prior written consent of Volcano Corporation is prohibited.
LIMITED WARRANTY Subject to the conditions and limitations on liability stated herein, Volcano Corporation (“VOLCANO”) warrants that the Volcano Precision Guided Therapy System (the “System”) as so delivered, shall materially conform to Volcano’s then current specifications for the System, for a period of one year from the date of delivery. ANY LIABILITY OF VOLCANO WITH RESPECT TO THE SYSTEM OR THE PERFORMANCE THEREOF UNDER ANY WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER THEORY WILL BE LIMITED EXCLUSIVELY TO SYSTEM REPAIR, REPLACEMENT OR, IF REPLACEMENT IS INADEQUATE AS A REMEDY OR, IN THE OPINION OF VOLCANO, IMPRACTICAL, TO REFUND OF THE PRICE PAID FOR THE SYSTEM. EXCEPT FOR THE FOREGOING, THE SYSTEM IS PROVIDED “AS IS” WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF FITNESS, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NONINFRINGEMENT. FURTHER, VOLCANO DOES NOT WARRANT, GUARANTEE, OR MAKE ANY REPRESENTATIONS REGARDING THE USE, OR THE RESULTS OF THE USE, OF THE SYSTEM OR WRITTEN MATERIALS IN TERMS OF CORRECTNESS, ACCURACY, RELIABILITY, OR OTHERWISE. Buyer understands that Volcano is not responsible for and will have no liability for any items or any services provided by any persons other than Volcano. Volcano shall have no liability for delays or failures beyond its reasonable control. Additionally, this warranty does not apply if: 1 The System is operated in other than a manner prescribed by Volcano Corporation in the Operator’s Manual, and/or supplements. 2 The System is operated in a manner that is not in conformance with purchase specifications and specifications contained in the Operator’s Manual, and/or supplements. 3 The System is not maintained in accordance with procedures in the Operator’s Manual, and/or supplements. 4 The System is repaired, altered, or modified in any way by other than Volcano Corporation authorized personnel, or without Volcano Corporation authorization. Contact Volcano Corporation, Technical Support for instructions and issuance of a Return Material Authorization if claims under this warranty become necessary and if the System or components of the System are to be returned. The System or components will not be accepted for warranty purposes unless the return has been authorized by Volcano Corporation.
Page 6 of 147
505-0100.16/002
System parts or components repaired or replaced under warranty bear the same warranty expiration date as the original equipment, or 90 days, whichever is longer. Consumable parts (data disks, batteries, among others) are warranted only against defects in materials and workmanship. System parts purchased outside the original warranty period are warranted for a period of 90 days, subject to all of the restrictions contained in this Limited Warranty. Use of unauthorized replacement parts may void the warranty. In all cases, Volcano Corporation will be the sole judge as to what constitutes warrantable damage.
505-0100.16/002
Page 7 of 147
Patents and Trademarks Patents This product, and the use thereof, may be covered by one or more of the following U.S. and international patents: Rotational IVUS Catheters 5257629, 5453575, 5601082, 5921931, 6036650, 6165128, 6200268, 6213950, 6381350, EP 0611291, EP 0707453, EP 0871043, GB 2246632, JP 3188470, JP 3194582 Digital IVUS Catheters 5257629, 5368037, 5453575, 5590659, 5601082, 5603327, 5779644, 5857974, 5876344, 5921931, 5935072, 5938615, 5993393, 6036650, 6049958, 6080109, 6110314, 6123673, 6165128, 6200268, 6213950, 6238347, 6254542, 6283920, 6283921, 6381350, 6618916, 6685646, 6776763, 6899682, 6962567, 7226417, AU 776527, DE 69213463.8, DE 69430490.5, DE 69432448.5, DE 69516444.9, EP 0596974, EP 0611291, EP 0637937, EP 0671221, EP 0707453, EP 0750883, EP 0871043, EP 1030600, EP 1198200, GB 2246632, GB 2287375, GB 2301892, JP 3188470, JP 3194582, JP 3344422, JP 3629141, JP 3732854, JP 3831743 VH and IVUS Consoles 5271404, 5368037, 5453575, 5590659, 5601082, 5603327, 5779644, 5857974, 5921931, 5935072, 5938615, 5993393, 6036650, 6049958, 6080109, 6110314, 6123673, 6165128, 6200268, 6213950, 6238347, 6254542, 6283920, 6283921, 6381350, 6618916, 6673015, 6776763, 6899682, 6962567, 7215802, 7226417, 7359554, AU 776527, DE 60038382.2, DE 69213463.8, DE P69516444.9, EP 0596974, EP 0611291, EP 0637937, EP 0671221, EP 0707453, EP 0750883, EP 0828164, EP 0871043, GB 2246632, GB 2287375, GB 2301892, JP 3188470, JP 3194582, JP 3344422, JP 3619845, JP 3732854, JP 3831743, RE40608 SpinVision 5257629, 5368037, 5453575, 5590659, 5601082, 5603327, 5715827, 5779644, 5857974, 5921931, 5935072, 5938615, 5993393, 6036650, 6049958, 6080109, 6106476, 6110314, 6123673, 6165128, 6200268, 6213950, 6238347, 6254542, 6283920, 6283921, 6381350, 6618916, 6776763, 6899682, 6962567, 6976965, 7097620, AU 776527, DE 69213463.8, DE P69516444.9, EP 0596974, EP 0611291, EP 0637937, EP 0671221, EP 0707453, EP 0750883, EP 0871043, GB 2246632, GB 2287375, GB 2301892, JP 3188470, JP 3194582, JP 3344422, JP 3619845 Page 8 of 147
505-0100.16/002
FFR Option 5257629, 5271404, 5368037, 5453575, 5590659, 5601082, 5603327, 5715827, 5779644, 5857974, 5921931, 5935072, 5938615, 5993393, 6036650, 6041662, 6049958, 6080109, 6106476, 6110314, 6123673, 6165128, 6200268, 6213950, 6238347, 6254542, 6283920, 6283921, 6381350, 6618916, 6663570, 6776763, 6899682, 6962567, 6976965, 7097620, 7134994, 7215802, 7226417, 7359554, RE 40608, AU 776527, DE 60038382.2, DE 69213463.8, DE P69516444.9, EP 0596974, EP 0611291, EP 0637937, EP 0671221, EP 0707453, EP 0750883, EP 0828164, EP 0871043, GB 2246632, GB 2287375, GB 2301892, JP 3188470, JP 3194582, JP 3344422, JP 3619845, JP 3732054, JP 3831743 SmartWire/BrightWire 5163445, 5271404, 5348481, 5358409, 5413508, 5551301, 5668320, 5715827, 5797856, 6041662, 6106476, 6265792, 6585660, 6663570, 6767327, 6976965, 7097620, 7274956, DE 69033354.4, DE 6927169.7, DE P69027169.7, DE P69114064.2, DE P69418888.3, EP 0419277, EP 0466424, EP 0709109, EP 0722623, EP 0828164, JP 3190667, JP 3235839, JP 3313723, JP 3425444, JP 3619845, JP 3624200 PrimeWire 5358409, 5413508, 5715827, 5797856, 6106476, 6210339, 6265792, 6767327, 6779257, 6976965, 7097620, 7676910, 7967762, AU7482294, AU3212895, AU4103396, CA2170036, CA2198909, CA2362933, CA2384160, DE69534748, EP0716775, EP0801536, EP1658808, EP0778746, EP1175175, EP1221170, JP9502049, JP10505269, JP3619845, JP10511586, JP3616569, JP3425444 Other U.S. and international patents are pending.
505-0100.16/002
Page 9 of 147
Trademarks The following are trademarks of Volcano Corporation: Volcano, the Volcano logo, VH, ChromaFlo, Visions, Avanar, Eagle Eye, VIBE, Revolution, PrimeWire and SmartWire are trademarks of Volcano Corporation and are registered in the United States and other countries. Precision Guided Therapy and CORE are trademarks of Volcano Corporation. PrimeWire PRESTIGE is a trademark of Volcano Corporation and is registered in the United States. In-Line Digital is a trademark of Volcano Corporation and is registered in the European Community. Pioneer and Pioneer Plus are trademarks of Medtronic, Inc.and are registered in the United States and other countries. Microsoft and PowerPoint are registered trademarks of Microsoft Corporation in the United States and other countries. DICOM is a registered trademark of National Electrical Manufacturers Association.
Page 10 of 147
505-0100.16/002
Warnings and Precautions Read and Review Manual before Operation Carefully read and review the entire Volcano CORE System Operator’s Manual before attempting to operate the system. Volcano Corporation makes no warranty, representation or condition of any kind, expressed or implied (including any warranty of merchantability, suitability or fitness for a particular purpose) respecting the misuse of the system or the reuse of the catheter. Volcano Corporation assumes no responsibility or liability for incidental or consequential damages which may result from reuse or misuse of the catheter.
WARNINGS are used to indicate the possibility of severe personal injury. Follow the instruction or procedure correctly to avoid injury to yourself, the patient, or other personnel. The warnings are identified by the exclamation symbol. CAUTIONS are used to indicate the possibility of damage to the equipment. Follow the instruction or procedure correctly to avoid damage to the equipment.
For Use only by Trained Medical Personnel Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. Only physicians or other persons with adequate medical training in catheter insertion procedures should use the Volcano system. Only those personnel who are familiar with its operation and who have been trained to perform the procedures for which this device is intended should use the system.
System Use Cautions and Warnings
CAUTION: For the Volcano CORE system, you can easily roll it by holding the hand grips on either side of the Control Console. Do not exceed a slow walking pace when moving the system to reduce risk of causing the unit to topple which may cause significant damage and/or operator injury.
CAUTION: A tipping hazard may occur if the unit is pushed while wheels are immobilized.
The Volcano system supplies diagnostic information when used in conjunction with the Volcano imaging catheters during ultrasonic imaging of peripheral and coronary vasculature. It is intended to be used as an adjunct to conventional angiographic procedures or interventional therapies such as balloon angioplasty.
505-0100.16/002
Page 11 of 147
CAUTION: Although the components are spill-resistant, avoid spilling or dropping any foreign material onto components. It is important to be especially careful with the keyboard, controller, CPU and the monitor.
The bedside-mounted Volcano system equipment complies with the fluid ingress requirements of IEC60529 (IPX4 for Control Console II and all other bedside peripherals) when configured for normal use. The bedside-mounted Volcano equipment should be located under a sterile drape when configured for normal use.
WARNING: The Volcano system must be properly grounded to avoid electrical shock. To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
WARNING: To prevent compromising patient isolation, the Volcano system console operator must not simultaneously touch the patient and/or any implanted catheter or guide wire and any part of the Volcano system mobile cart or computer chassis or connector interface.
NOTE: Within the U.S.A., a hospital-grade receptacle must be used.
WARNING: Hand crush/pinch potential when positioning device parts.
CAUTION: The Volcano system must have the original cord, or installed electrical power in an Volcano integrated system must be used at all times. The Volcano systems are protected against the voltages of defibrillation; still, we recommend that you disconnect the catheter from the patient interface module prior to defibrillation.
CAUTION: Grounding reliability can only be achieved when equipment is connected to an equivalent receptacle marked “hospital only” or “hospital grade.”
CAUTION: Do not obstruct access to the main power cord when plugged into wall socket.
CAUTION: Do not connect Volcano equipment to non-medical grade or ungrounded power strip, especially when shared with non-medical grade equipment.
For cardiac catheterization applications, the Volcano system must be connected to the potential equalization system of the hospital room.
CAUTION: The Volcano system is a high-gain wide-band patient connected intravascular ultrasound (IVUS) system intended for use during diagnostic or interventional percutaneous coronary or peripheral procedures. As such, the system is susceptible to in-band (5-60MHz) reciprocal interfering signals. Reciprocal interference is non-synchronous to the IVUS system and typically transient in nature. When local intensities are sufficiently high, non-synchronous in-band transient interference will be visible on the IVUS display as random “speckle” like noise, or faint, intermittent radial spokes or rings. This type of electromagnetic interference is an annoyance to the operator but typically does not render the device unusable. Non-transient (modulated continuous wave transmitters) with in-band center frequency carriers can, under high local intensity levels, “white out” the IVUS image. Under this extreme condition the IVUS system is rendered in-operable. Whenever electromagnetic interference renders the IVUS system inoperable, the appropriate action is to identify the
Page 12 of 147
505-0100.16/002
source of the interfering signal and reduce the in-band local intensity levels sufficient to operate the IVUS system.
CAUTION: This device is not intended for use in the presence of flammable substances which could cause combustion.
CAUTION: The Volcano system should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary, the system should be observed to verify normal operation in the configuration in which it will be used.
WARNING: Portable and mobile RF communications equipment can affect
MEDICAL ELECTRICAL EQUIPMENT. See Chapter 18, Technical Specifications
for the recommended separation distances between portable and mobile RF communications equipment and the Volcano Model equipment.
WARNING: The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of the system as replacement parts for internal components, may result in increased emissions or decreased immunity of the system.
WARNING: Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (i.e. IEC 60950 for data processing equipment and IEC 60601-1:2005 for medical equipment). Furthermore all configurations shall comply with the system standard IEC 60601-1, Clause 16. Anyone who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible that the system complies with the requirements of IEC 60601-1-1:2000. If in doubt, consult the technical services department or your local representative. In specific, AC Mains powered devices are not recommended unless approved and installed by Volcano Corporation.
CAUTION: Non-Medical equipment supplied as part of the Volcano Imaging System is intended to be connected to a multiple socket-outlet isolation transformer. If any Volcano or customer-supplied equipment is connected directly to a wall outlet or a multi-socket outlet, this may result in excessive leakage current per IEC 60601-1 and presents a risk of electric shock to the operator and/or patient. The user must verify that the leakage current remains below the IEC 60601-1 limits.
WARNING: Do not connect a multiple socket-outlet or extension cord to the system. This may exceed the safety limits of the system and void the warranty.
WARNING: The Volcano system contains no user-serviceable components. To avoid electric shock, do not remove any panels or covers. In the event of malfunction or system damage, turn the system off, unplug the system from the power receptacle, and contact a qualified service person and Volcano Customer Service.
WARNING: No modification of this equipment is allowed.
WARNING: This instrument is NOT explosion proof. This instrument has been designed and manufactured to minimize the hazard, but the risk, although low, has not been completely eliminated. An explosion risk can exist in sufficiently high atmospheric concentrations of such anesthetics or agents, mixed with air, or with oxygen or with nitrous oxide. The probability of occurrence of the ignition of such anesthetic mixtures depends upon their concentration, the appropriate minimum ignition energy, the presence of high surface temperatures, and the energy of sparking. Sparks can be caused where
505-0100.16/002
Page 13 of 147
electrical circuits are opened or closed by the operation of switches, connectors, fuses, or over-current releases and the like. Operator action: The operator shall observe care when using this instrument in areas in which flammable anesthetics or flammable agents for disinfection or cleaning are applied. In the event, the atmospheric concentrations of the flammable agents are elevated, the unit should not be powered OFF if running, or should not be powered ON if it is OFF.
PIM Use Cautions and Warnings
CAUTION: All bedside mounted peripherals should be securely placed to avoid injury to the user or patient.
CAUTION: The patient interface module’s magnetic strip, which allows it to be attached to various surfaces during use, can damage audiotapes, computer tapes, computer disks, and other magnetically sensitive components. Do not place the PIM near these items.
CAUTION: Do not damage the PIM’s cable by rolling equipment on it or using excessive force when disconnecting it.
CAUTION: If you drop the PIM, you may cause permanent damage to the external packaging and internal electronics. Do not use the system if the outer case of the module appears damaged.
CAUTION: The PIM should not be placed below the IV pole where liquids may drip into the catheter connector and cause damage.
CAUTION: The PIM cable is susceptible to damage if not stored properly. Never let the PIM cable lay on the floor. Store the PIM cable in a manner where the connector end cannot be damaged by personnel, gurneys or table movements. There must be sufficient slack in the cable when stored on the table to avoid binding during table movements.
CAUTION: If the PIM, SpinVision® (PIMr), and/or Pimmette are moved while being used with a patient and causes the catheter to be displaced in the body, there is significant risk to the patients’ safety. Please ensure that the PIM, SpinVision (PIMr), and/or Pimmette are securely placed at all times.
Catheter and Wire Use Cautions and Warnings NOTE: See the package insert for a complete description of product usage, warnings, and precautions.
Page 14 of 147
505-0100.16/002
Contact Information United States: Volcano Corporation 2870 Kilgore Road Rancho Cordova, CA 95670 USA Phone: 916.638.8008 Phone: 800.228.4728 (USA and Canada) Fax: 916.638.8112 www.volcanocorp.com Authorized European Representative: Volcano Corporation Europe BVBA/SPRL Excelsiorlaan 41 B-1930 Zaventem, Belgium Phone: +32.2.679.1076 Fax: +32.2.679.1079
505-0100.16/002
Page 15 of 147
This page is intentionally blank for pagination purposes.
Page 16 of 147
505-0100.16/002
Chapter 1: Overview Introduction The Volcano Precision Guided Therapy System provides qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. Intravascular ultrasound (IVUS) utilizes the acoustic impedance of vascular structures to provide cross sectional images from inside the vessel. The IVUS catheter uses a transducer near the distal tip to emit and receive high frequency sound waves.
Figure 1: IVUS catheter within vessel The system is then able to analyze the signal that is received by the transducer to differentiate between vessel structures to produce a 360º cross sectional image.
505-0100.16/002
Page 17 of 147
IVUS Transducer
Vessel Border
Lumen Border
Figure 2: Grayscale IVUS image These grayscale images can then be enhanced using VH IVUS. VH analysis provides automatic border detection for the vessel and lumen borders, as well as plaque composition. Plaque is automatically classified into four categories in order to simplify interpretation of the IVUS image:
Page 18 of 147
FI Fibrous (green) FF Fibro-Fatty (light green) NC Necrotic Core (red) DC Dense Calcium (white)
505-0100.16/002
Figure 3: VH display with automatic borders and tissue classification Alternatively, the ChromaFlo feature can be used to identify the blood flow. The ChromaFlo feature uses patented technology to provide a visual depiction of blood flow through the vessel. This is accomplished by overlaying a two-dimensional color mapping of relative blood flow velocity onto the grayscale ultrasound image.
Figure 4: False Lumen in the right iliac identified using ChromaFlo feature
505-0100.16/002
Page 19 of 147
Indications for Use The Volcano Precision Guided Therapy System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion. VH IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS system is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations. The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures. Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the SpinVision (PIMr) withdraws the imaging core within the protective sheath for a maximum of 15 cm.
Clinical Applications The system is used to evaluate vascular morphology and measure blood pressure in the coronary arteries and vessels of the peripheral vasculature.
Contraindications Use of the Volcano system is contraindicated wherever tissue or organ damage is a reasonable probability. The catheter is not for fetal use.
Possible Adverse Reactions The use of the Volcano IVUS imaging catheter-or any percutaneous intravascular catheter-could result in adverse reactions, including, but not limited to:
Bleeding at the entry puncture site
Injury to vascular wall
Thrombosis of the vessel
Page 20 of 147
505-0100.16/002