Volcano CORE Mobile User manual

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 3.4.X/3.5.X

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Legal Manufacturer:
Volcano Corporation
2870 Kilgore Road
Rancho Cordova, CA 95670 USA
Phone: [phone] (USA and Canada)
IGTD.remotesuppor[email protected]
International:
[phone]
IGTDCustomerService-I[email protected]
European Authorized Representative:
Volcano Europe SA/NV
Excelsiorlaan 41
B-1930 Zaventem, Belgium
Phone: [phone]
Fax: [phone]
© 2020 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: September 2020
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.
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.

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Table of Contents
PATENTS AND TRADEMARKS ................................................................................................................... 8
PATENTS ....................................................................................................................................................... 8
TRADEMARKS ................................................................................................................................................. 8
WARNINGS AND PRECAUTIONS ............................................................................................................... 9
READ AND REVIEW MANUAL BEFORE OPERATION ................................................................................................. 9
FOR USE ONLY BY TRAINED MEDICAL PERSONNEL ................................................................................................. 9
SYSTEM USE CAUTIONS AND WARNINGS ............................................................................................................. 9
PIM USE CAUTIONS AND WARNINGS ............................................................................................................... 12
CATHETER AND WIRE USE CAUTIONS AND WARNINGS ......................................................................................... 13
CHAPTER 1: OVERVIEW .......................................................................................................................... 14
INTRODUCTION............................................................................................................................................. 14
INDICATIONS FOR USE.................................................................................................................................... 17
CLINICAL APPLICATIONS.................................................................................................................................. 18
CONTRAINDICATIONS ..................................................................................................................................... 18
POSSIBLE ADVERSE REACTIONS ........................................................................................................................ 18
CHAPTER 2: SYSTEM DESCRIPTION......................................................................................................... 20
SYSTEM OVERVIEW ....................................................................................................................................... 20
MONITOR.................................................................................................................................................... 21
CONTROL CONSOLE ....................................................................................................................................... 22
JOYSTICK CONTROLLER OPTION........................................................................................................................ 25
WORKSTATION (CENTRAL PROCESSING UNIT)..................................................................................................... 27
PRINTER ...................................................................................................................................................... 27
CONNECTOR PANEL ....................................................................................................................................... 27
PATIENT INTERFACE MODULE.......................................................................................................................... 30
CATHETERS .................................................................................................................................................. 30
AVAILABLE OPTIONS ...................................................................................................................................... 31
CHAPTER 3: SYSTEM SETUP.................................................................................................................... 32
OVERVIEW................................................................................................................................................... 32
INSTALLATION............................................................................................................................................... 32
TURNING SYSTEM ON.................................................................................................................................... 33
IVUS SOFTWARE SETTINGS............................................................................................................................. 33
CHAPTER 4: PREPARING FOR A CASE...................................................................................................... 44
OVERVIEW................................................................................................................................................... 44
ENSURE SYSTEM POWER IS ON........................................................................................................................ 44
CONNECT THE PIM ....................................................................................................................................... 45
ENTER PATIENT INFORMATION ........................................................................................................................ 46
CHAPTER 5: ACQUIRING IVUS IMAGES ................................................................................................... 48
OVERVIEW................................................................................................................................................... 48
INSERT THE CATHETER.................................................................................................................................... 48
ADJUST THE IMAGE (IF DESIRED) ...................................................................................................................... 49
CHAPTER 6: RECORDING IVUS IMAGES .................................................................................................. 54

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OVERVIEW................................................................................................................................................... 54
RECORDING A VIDEO LOOP ............................................................................................................................. 54
SAVING A FRAME .......................................................................................................................................... 56
CHAPTER 7: REVIEWING IVUS IMAGES ................................................................................................... 57
OVERVIEW................................................................................................................................................... 57
REVIEWING SAVED FRAMES ............................................................................................................................ 58
REVIEWING VIDEO LOOPS............................................................................................................................... 58
DISPLAY MODE............................................................................................................................................. 64
PRINTING .................................................................................................................................................... 64
CHAPTER 8: MAKING MEASUREMENTS AND ANNOTATIONS ................................................................. 67
MAKING MEASUREMENTS .............................................................................................................................. 67
CHAPTER 9: USING VH IVUS ................................................................................................................... 76
OVERVIEW................................................................................................................................................... 76
ACTIVATING VH DISPLAY ................................................................................................................................ 77
USING THE VH SCREEN .................................................................................................................................. 78
USING TARGET ASSIST.................................................................................................................................... 81
CHAPTER 10: USING THE CHROMAFLO FEATURE.................................................................................... 82
OVERVIEW................................................................................................................................................... 82
ACTIVATING THE CHROMAFLO FEATURE ............................................................................................................ 82
CONTROLLING THE SENSITIVITY ........................................................................................................................ 83
SETTING THE REGION OF INTEREST.................................................................................................................... 83
DEACTIVATING THE CHROMAFLO FEATURE ........................................................................................................ 84
CHAPTER 11: ENDING AN IVUS CASE...................................................................................................... 86
OVERVIEW................................................................................................................................................... 86
ENDING A CASE ............................................................................................................................................ 86
DELETING A CASE.......................................................................................................................................... 87
CHAPTER 12: ARCHIVING AN IVUS CASE ................................................................................................ 88
OVERVIEW................................................................................................................................................... 88
ARCHIVING OPTIONS ..................................................................................................................................... 88
ARCHIVING USING DICOM ............................................................................................................................ 90
PRINTING IMAGES ......................................................................................................................................... 90
CHAPTER 13: SWITCHING MODES .......................................................................................................... 92
OVERVIEW................................................................................................................................................... 92
ENTERING PATIENT INFORMATION.................................................................................................................... 92
SWITCHING MODES....................................................................................................................................... 92
CHAPTER 14: RETRIEVING AND DELETING AN IVUS CASE ....................................................................... 94
OVERVIEW................................................................................................................................................... 94
RETRIEVING A CASE ....................................................................................................................................... 94
DELETING A CASE.......................................................................................................................................... 95
REMOVING POWER FROM SYSTEM ................................................................................................................... 96

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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....................................................................................................................................................... 117
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 ............................................................................................................................................. 135
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.............................................................................................................. 147

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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 NON-
INFRINGEMENT. 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:
1The System is operated in other than a manner prescribed by Volcano Corporation in
the Operator’s Manual, and/or supplements.
2The 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.
3The System is not maintained in accordance with procedures in the Operator’s
Manual, and/or supplements.
4The 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.

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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.

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Patents and Trademarks
Patents
See Patents (www.philips.com/patents).
Trademarks
Trademarks are the property of Koninklijke Philips N.V. or their respective owners.

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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.

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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 un-
grounded 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