using the revolutiontm rotating imaging catheter
Contents
1. VOLCANO Volcano Revo Option For use with the Volcano s5 s5i Series Systems Operator s Manual Software Version Level 3 3 X C 0086 Complies with the Council Directive 93 42 EEC A TUVRheinland Volcano systems meet TUV s safety requirements A SPECIFIC STANDARDS TUVRheinland 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 Please refer to www volcanocorp com for instructions on disposal Ia 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 2012 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 November 2012 Page 2 of 22 505 0100 14 002 Table of Contents MERTEN 4 PATENTS AND TRADEMARKG cccsscsssssscssecssssesssnecsesssnssessecssnssessecsscssossscssesssses2. entire range of measurement achievable with the Revolution 45MHz Rotational IVUS Imaging Catheter These are worst case measurement uncertainties and represent situations where the ultrasound signals are entirely within tissue such as muscle which has a very different speed of sound than blood For measurement of luminal boundaries where the ultrasound only traverses through blood the inaccuracy is Distance Measurement 1 of the measurement 0 10mm Area Measurement 5 of the measurement 0 10mm7 NOTE A slight difference in total pullback length displayed on SpinVision PIMr and ILD may exist due to the latent response in initiation termination of the pullback relative to recording This discrepancy only exists in the most proximal and distal 1mm of the video loop In Line Digital measurement accuracy e Two distance measurements on the longitudinal display ILD e Maximum Loop Distance Z axis length 0 5 mm sec pull back amp 30fps limited by memory of 5400 frames 90 mm e Maximum Loop Distance Z axis length 1 0 mm sec pull back limited by device dimension 150 mm e Accuracy including software and SpinVision PIMr accuracy 4 of the measurement NOTE In rare situations the actual pullback speed may differ from the expected value This could result in erroneous length information derived from the ILD This can be caused by restricted motion of the PIMr or simultaneous activation of the speed controls on t
3. hand corner of the Home screen image Perform 1 2 ing an Automatic Pullback Using the 014 guide wire advance the catheter to the most distal portion of the target lesion according to standard intervention procedures Select the pullback speed by pressing the AUTO button on SpinVision PIMr which toggles between 0 5 mm and 1 0 mm per second To zero the distance counter press RESET Select Image on SpinVision PIMr or the Image On Live button on the system screen to begin imaging The SpinVision PIMr motor will begin spinning and the Revolution image will appear on the system screen The absolute movement of the transducer will be displayed on the digital readout on SpinVision PIMr The Image Off Freeze Save Frame Record Pullback and Adjust Image buttons become visible on the system screen To stop imaging at any time simply select the IMAGE button on SpinVision PIMr or the Image Off Freeze button on the system The image currently displayed on the screen remains there Note Starting or stopping imaging also starts or stops the rotation of the catheter NOTE If an image artifact is observed it may be necessary to flush the imaging core with a 3 cc syr inge of heparinized saline attached to the Revolution catheter port SpinVision PIMr 5 Press PULLBACK on SpinVision PIMr or Record Pullback on the system Pullback begins at the selected speed and the Volcano system begins to record the
4. kind expressed or implied including any warranty of merchantability suitability or fitness for a particular purpose respecting the misuse of the system software or catheter VOLCANO Corporation assumes no responsibility or liability for incidental or consequential damages which may result from re use or misuse of the system software or catheter WARNING Always ensure that SpinVision PIMr is placed in a stable location and is clear from items that may interfere or prevent smooth movement during use The SpinVision weight will transfer as the device performs a pullback WARNING SpinVision s PIMr cable may be damaged if equipment is rolled on it Do not pull on the cable place the cable in a high traffic area or use excessive force as the strain relief ends may be damaged Do not use the system if the outer case or wires appear damaged WARNING Do NOT advance SpinVision PIMr while the catheter is imaging NOTE SpinVision PIMr complies with the fluid ingress requirements of IEC 60529 IPX4 when configured for normal use SpinVision PIMr should be located under a sterile drape when configured for normal use Page 6 of 22 505 0100 14 002 NOTE Please refer to the Volcano system operator s manuals for detailed information about the operation of the Volcano system Pay careful attention to all Cautions and Warnings CAUTION Do not use a damaged catheter Do not re sterilize the catheter Cath
5. video loop NOTE SpinVision PIMr can accommodate a maximum pullback distance of 15 cm after which it stops the pullback Page 16 of 22 505 0100 14 002 NOTE The pullback distance may be limited to 9 cm if the acquisition rate is set at 30 frames sec and a pullback rate of 0 5 mm sec is used Adjust the acquisition rate to 15 f s or pullback rate to 1 0 mm sec to obtain the entire 15 cm 6 Once the desired pullback distance is reached you may stop the pullback by pressing the PULLBACK button on SpinVision PIMr or by pressing the Stop button on the system or software Performing a Manual Pullback 1 Select MANUAL on SpinVision PIMr SpinVision PIMr unlocks from the sled so that you can move it by hand 2 Select IMAGE on SpinVision PIMr or the Image On Live button on the Home screen 3 Select PULLBACK on SpinVision PIMr or Record Pullback on the Home screen 4 Gently pull SpinVision PIMr back at the desired speed Utilize the rubber grips on the side of SpinVision PIMr to enhance control 5 Press STOP on the Home screen to stop recording the video loop NOTE 1 The digital display can be reset at any time to give the absolute position NOTE 2 If the SpinVision PIMr motor drive is left stationary for more than 30 seconds while in Manual mode the system will switch to Auto mode and lock the sled into place WARNING Do NOT advance SpinVision PIMr while the catheter i
6. ACTIR cece crceceeesecnaecaeeescsaesaeseeessecaeeseseaesaseatenee 19 CHAPTER 5 TECHNICAL SPECIFICATIONG csccssssssssssssssssecsssssssecssesseseesessssssessoes 21 SPINVISION PIMR DIMENSIONS AND WEIGHTS 000 ccceeeecseeee caste ceeaeteeeaeeee 21 CATHE TER SPECIBICA TIONS vise sccsisesssectentovsesetessseupensogetesnoccountenssoaggssbscetus ovtedutssapuueed AS 21 MEASUREMENT ACCURACY aroni oa a a A beer 22 PACKAGING EE 22 505 0100 14 002 Page 3 of 22 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 PIMr SpinVision 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 PR
7. ICE 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 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 Field Service for instructions and issuance of a Return Material Authorization if claims under this warra
8. ce Try another catheter If these do not resolve the problem call Volcano Technical Support The unit has failed Call Volcano Technical Support The unit has failed Call Volcano Technical Support The unit has failed Call Volcano Technical Support Catheter rotation has stalled Ensure the catheter has been prepared and flushed per the catheter IFU If this does not correct the problem call Volcano Technical Support Ensure the pullback has not come to the end of its travel Check the cable for binding and the catheter for excessive drag in the body If these do not correct the problem call Volcano Technical Support The unit has failed Call Volcano Technical Support sheath Non Uniform Rotational Distortion NURD catheter Artifact Cause Resolution Degraded image due to Air surrounding the IVUS Flush with heparinized saline per shadowing transducer within the catheter IFU Excessive tightening of the hemostasis valve Excessive bending of the Loosen the hemostasis valve Make sure catheter is not bent between SpinVision PIMr and hemostasis valve Flushing with heparinized saline may also help Ring artifact in image sheath Air surrounding the IVUS transducer within the catheter IFU Flush with heparinized saline per 505 0100 14 002 Page 19 of 22 This page is intentionally blank for pagination purposes Page 20 of 22 505 0100 14 002 Chapter 5 Technical Specif
9. de LIVE Gummi OFF Ring Down OFF WH OFF Catheter Revolution Figure 4 Time Gain Compensation Dialog Box To set the TGC 1 2 3 Page 14 of 22 Select the TGC button in the Adjust Image screen Note that you must be imaging with a Revolution catheter for the TGC feature to be enabled Select from one of the preset profiles using the drop down box or arrow keys Move the sliders or use the arrows to set the gain for each desired region as indicated by the number of mm shown to the left of each slider Click Close to save your settings and close the dialog box If you do not want to save any changed settings click Reset The settings will be restored to the default settings 505 0100 14 002 Using Hi Q Feature The Hi Q feature allows selection from multiple Revolution imaging options to provide an option that best allows the user to differentiate between blood speckle and tissue along lumen border It must be enabled in the Adjust Image screen before recording images BETTOL TINS storsice stories e ereo oro V 06 04 2012 11 31 04 Time Gain Compensation Radius mm E e men nd ET a l mme sl _ E E TI N FOON Display Mode LIVE ChromaFio OFF Ring Down OFF Hit OFF Catheter Revolution Figure 5 Hi Q Settings Hi Q has three Revolution imaging mode settings e Off Imaging equivalent to systems with software versions prior to 3 3 X e Level 1 Imaging with a darker and fi
10. ecsesssnsesse 5 PATENTS sees dee Ee 5 TRADEMARKS eegener eene eege eege EE Eet dees vena EEE E E soeiseas 5 WARNINGS AND PRECAUTIONS cscsssssssssssssesscssssesssssnessesssnssessecsscssesssscsessssssecsesssnseesee 6 FOR USE ONLY BY TRAINED MEDICAL PERSONNEL A 6 READ AND REVIEW MANUAL BEFORE OPER ATION A 6 CONTACT INFORMATION csccssssssssssssssscsssssssscssessecsscsssssscssesssssnecsesssnsscssocsscsssssnecsesssssoeees 7 ENTENTE 9 DEVICE DESCRIPTION ss Eet totaa ahea A ta aaae aa test aA a ARa ted eg EE ae Eas eet EEeEE EE 9 INTENDED USE EE 10 INSTALLATION TE 10 CATHETERS E 10 CHAPTER 2 PREPARING FOR A CASE eeseseesosseseecesoeseseeeosoeseeoceossesecocsosseseeeesoeseeoceoseeseesesoe 11 CONNECTING SPINVISION PIMR TO THE SYSTEM 11 PREPARING SPINVISION PIMR FOR USB teste resis reegen SOARES 11 CHAPTER 3 ELE LE 13 SETTING PULCEBACK SPEED psccsssiaieesioveseas ating an a a a A EES 14 USING TIME GAIN COMPENSATION TGC scisssicdsccisasasssaseccdnsansondnipancduavsonrassuesuadavsoevensves 14 USING HOM FEATURE nire r AON A AEA cat alee a catenin ca 15 PERFORMING AN AUTOMATIC PULLBACK sesssesssssssssssssseserstssrsreresrssententsesseseenesersenee 16 PERFORMING A MANUAL PULLBACK 17 POST IMAGING PROCEDURE si ccccctcssccsssssesseistcsessasssnssbegdessosevsdensebevastoseossesbeavapentesebiees 17 CHAPTER 4 TROUBLESHOOTING cscsssssssssssssscessesessecsscssessecssesssssnecsesssseseesesssrssessees 19 POTENTIAL IMAGING ARTI
11. eters are shipped sterile for single use In the event of damage contact Volcano Corporation personnel CAUTION The top surface of SpinVision PIMr Models 808884001 and 808884001 R can become hot to the touch during prolonged periods of use 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 14 002 Page 7 of 22 This page is intentionally blank for pagination purposes Page 8 of 22 505 0100 14 002 Chapter 1 Overview This manual is intended to provide information specific to the Volcano Revo option for use on the Volcano system Please refer to the Volcano system operator s manuals for information regarding the system and its functionality Device Description The Volcano Revo option kit is a required accessory to the Volcano system when using the Revolution 45MHz Rotational Imaging Catheter for intravascular ultrasound imaging This option consists of a Patient Interface Module PIM called SpinVision PIMr which can be simply connected to the existing Volcano system PIM cable Figure 1 Volcano Revo Option Patient Interface Module SpinVision PIMr The ability to perform an automatic or manual pu
12. he PIMr and system Packaging Catheters are shipped sterile for single use In the event of damage contact Volcano Corporation personnel CAUTION Do not use a damaged catheter Do not re sterilize the catheter Page 22 of 22 505 0100 14 002
13. ications NOTE Refer to Volcano system operator s manuals for system specifications SpinVision PIMr Dimensions and Weights a Height Width Depth Weight 3 9 in 4 0 in 14 4 in 3 2 Ib 3 9 in 4 0 in 14 4 in 2 9 Ib Catheter Specifications Imaging catheter Revolution 45MHz Rotational IVUS Imaging Catheter Transducer type Piezoelectric Frequency Revolution 45MHz Rotational IVUS Imaging Catheter 360 view single element rotating transducer Lumen characteristics coaxial guide wire lumen Catheter Crossing Profile at Maximum guide Transducer wire Revolution 3 2F 1 07 mm 0 014 0 36 mm Catheter Minimum ID guiding Length cm catheter clearance Revolution 6F 1 63 mm 2 064 135 NOTE Refer to Instructions for Use IFU that accompanies each catheter or go to www volcanocorp com to view detail catheter use specifications and acoustic output 505 0100 14 002 Page 21 of 22 Measurement Accuracy Measurements obtained with the Revolution 45MHz Rotational IVUS Imaging Catheter are subject to the following measurement inaccuracies due to variations in tissue speed of sound and display limitations The measurement precision is limited in both relative and absolute ranges Distance Measurement 4 5 7 0 of measured value 0 10mm Area Measurement 9 14 of measured value 0 10mm7 These uncertainties apply to the
14. llback is integrated into the SpinVision PIMr pullback device The controls available on SpinVision PIMr include the following buttons e Reset Resets the LED distance display to zero e Image Press once to begin imaging Press a second time to stop imaging The Revolution catheter will rotate while in imaging mode e Pullback Press to begin an automatic pullback Press again to stop the pullback e Auto Offers two automatic pullback rates 1 0 and 0 5 mm sec e Manual Offers manual control of pullbacks 505 0100 14 002 Page 9 of 22 Intended Use The Volcano Revo option is used for qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature It is used as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures The pullback feature of the PIMr withdraws the Revolution catheter s imaging core within the protective sheath for a maximum of 15cm Installation To ensure proper operation and warranty coverage the Volcano system must be installed and tested by following the Device Installation and Operational Qualification that accompanies each device Catheters Revolution 45MHz Rotational Imaging Catheter 89000 Note The Revolution catheter is intended for the intravascular ultrasound examination of coronary arteries Intravascular ultrasound imaging is indicated in patients who are candidates for tra
15. m screen 505 0100 14 002 Page 11 of 22 WARNING Always ensure that SpinVision PIMr is placed in a stable location and is clear from items that may interfere or prevent smooth movement during use The SpinVision PIMr weight will transfer as the device performs a pullback CAUTION The IVUS PIM SpinVision PIMr and the FFR Pimmette are strongly attracted to the magnetic field of Stereotaxis units The user should observe caution in handling these devices when less than 110cm from the center of these fields in order to prevent damage to the device or personal injury should these devices become free inside these very strong magnetic fields For reliable operation SpinVision PIMr must be further than 110cm from the center of the magnetic field of a Stereotaxis unit Inside of this limit the image may become frozen on the monitor until the unit is moved to outside this limit Placement of the SpinVision PIMr inside this limit may damage the SpinVision PIMr Page 12 of 22 505 0100 14 002 Chapter 3 Imaging Once the Revolution 45MHz catheter and SpinVision PIMr device are connected the system will display the following on the Home screen i VOLCANO TNE EES IMAGING OFF 09 29 2011 13 55 48 SS Save Frame Record Pullback Adjust Image Patient Home VA EndCase Archive Retrieve Press Image to Begin Imaging Display Mode DISABLED Chramaflo OFF Ring Down OFF WH OFF Cathe
16. ner blood speckle appearance than in Off mode default setting e Level 2 Imaging with a darker and finer blood speckle appearance than in Level 1 Mode To enable Hi Q select Level 1 or Level 2 from the Hi Q drop down menu NOTE 1 The selection of Hi Q settings should occur before recording video loops NOTE 2 In Level 1 or Level 2 mode diameter choices are limited to 8mm and 10mm The Off mode allows the user to use the full range of catheter Diameters 8mm 10mm 12mm and 14mm Diameter controls the depth of field view in which ultrasound data is displayed Selecting Level 1 and Level 2 using unsupported diameters results in the message displays shown below For example if Level 1 or Level 2 is selected and then Diameter is set to12mm or 14mm the following message displays 505 0100 14 002 Page 15 of 22 Hi Q does not support the 12mm or 14mm diameters Select OK to change the diameter and set Hi Q Off Cancel Figure 6 Disable Hi Q Message Conversely if Diameter is set to 12mm or 14mm and then Level 1 or Level 2 is selected the followi ng message displays Hi Q does not support the 12mm or 14mm diameters Select OK to set the Diameter to 10mm and enable Hi Q Figure 7 Enable Hi Q Message Disable Hi Q by selecting Off from the Hi Q drop down menu When the Hi Q feature is set to Off a visual indicator Hi Q Off appears under the L VE text located on the upper left
17. ng SpinVision PIMr for Use 1 2 3 Remove the sterile equipment drape from the Revolution box While maintaining sterility remove the sterile drape from its protective packaging This step requires two people The sterile person opens the sterile drape on the side with the green arrows placing his or her hands in the back of the fold s to keep it open The second person places SpinVision PIMr into the sterile drape as far as it will go in the direction of the green arrow on the drape Unfold and pull the drape all the way out This will cover SpinVision s PIMr cable far enough to extend out of the sterile field Once the catheter has been prepped per the Instructions for Use IFU insert the sterile drape catheter port into the SpinVision PIMr catheter port Remove the sterile barrier sticker from the drape so you can insert the catheter Insert the catheter into the SpinVision PIMr port with the black marks on the catheter and SpinVision PIMr port aligned then lock it in place by rotating it 30 clockwise A message on the Volcano system screen reads Catheter detected The system is ready for imaging once the Press Image to Begin Imaging message displays With the catheter telescope in the most distal position clip the telescoping hub into the SpinVision s PIMr catheter arm Press the Image button on SpinVision PIMr or the Image On Live button on the system Home screen The image appears on the syste
18. nsluminal interventional procedures Page 10 of 22 505 0100 14 002 Chapter 2 Preparing for a Case Refer to the Volcano system operator s manuals for the general instructions on preparing for an IVUS case Connecting SpinVision PIMr to the System SpinVision PIMr excites the catheter s transducer element to transmit ultrasonic energy to the surrounding tissue It then amplifies and processes the resulting echo signals from the transducer and sends them to the system through the connection on the system s rear panel 1 Connect the PIM cable to the rear of SpinVision PIMr Orient the marker on the cable connector to align with the marker on the PIM connector then slide the connector in If you need to remove the cable from SpinVision PIMr rotate the collar on the SpinVision PIMr cable connector counterclockwise a quarter turn and then pull back SpinVision PIMr performs a diagnostic self test and displays any errors on the system screen The SpinVision PIMr connection will be confirmed in the lower right hand section of the screen A green light with the words Rotational will display once SpinVision PIMr is connected WARNING SpinVision s PIMr cable may be damaged if equipment is rolled on it Do not pull on the cable place the cable in a high traffic area or use excessive force as the strain relief ends may be damaged Do not use the system if the outer case or wires appear damaged Prepari
19. nty 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 System parts or components repaired or replaced under warranty bear the same warranty expiration date as the original equipment 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 Page 4 of 22 505 0100 14 002 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 7074188 8104479 JP 2005537052 7215802 8105237 JP 2007105450 7359554 EP 1534137 JP 2007518488 7463759 EP 1534139 JP 2007526083 7627156 EP 1536727 JP 2008526387 7789834 EP 1703842 JP 2008543511 7874990 EP 1732461 JP 2009530068 7899224 EP 1903944 JP 2011036680 7927275 EP 1933711 JP 2011245326 7930014 EP 1996080 JP 2011521730 7940969 EP2291121 JP4700622 7978916 JP 2005536265 JP4773092 7988633 JP 2005536289 JP4481824 Other U S and international patents are pending Trademarks The f
20. ollowing are trademarks of Volcano Corporation Volcano and the Volcano logo are trademarks of Volcano Corporation and are registered in the United States and other countries Revolution is a registered trademark of Volcano Corporation Hi Q is a trademark of Volcano Corporation s5 is a trademark of Volcano Corporation S5i is a registered trademark of Volcano Corporation SpinVision is registered in the United States and is a trademark in the European Community and Japan In Line Digital is a trademark of Volcano Corporation and is registered in the European Community 505 0100 14 002 Page 5 of 22 Warnings and Precautions WARNINGS are used to indicate the possibility of severe personal injury Follow the instruction or procedure correctly to avoid injury to the operator patient or other personnel The warnings are identified by the exclamation symbol Ab 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 CAUTION FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR PROPERLY LICENSED PRACTITIONER Read and review manual before operation Carefully read and review the entire Volcano system operator s manual Refer to the section Warnings and Precautions VOLCANO Corporation makes no warranty representation or condition of any
21. s imaging Post Imaging Procedure 1 Remove the Revolution catheter using standard interventional procedures 2 Detach the catheter from SpinVision PIMr by rotating the port counterclockwise 30 to unlock it and removing the telescoping hub from the SpinVision PIMr arm 3 Dispose of the Revolution catheter 4 Remove SpinVision PIMr from the sterile drape ensuring that no blood or fluid comes into contact with it 5 Dispose of the sterile drape NOTE After the SpinVision PIMr is removed the screen area will continue to display the appropriate information for the last type of PIM used 505 0100 14 002 Page 17 of 22 This page is intentionally blank for pagination purposes Page 18 of 22 505 0100 14 002 Chapter 4 Troubleshooting These error messages are displayed on the right hand side of the SpinVision PIMr message display Use the following table to read the description and recommended action Meaning SpinVision PIMr passed self test Unable to read RFID TGC memory failure Analog high voltage failure One of the pulse width control pins is stuck low Catheter motor failure Pullback motor driver failed EEPROM data error Potential Imaging Artifacts Suggested User Manual Text This code displays briefly after the unit is powered on and indicates that the unit is ready The catheter may be faulty or may not be fully rotated into place Ensure the catheter is fully rotated into pla
22. ter Revolution Figure 2 Main System Screen Image Off Select Image On Live button on the system screen or the IMAGE button on SpinVision PIMr to begin imaging The SpinVision PIMr motor will begin spinning and the Revolution image will appear on the system screen VOLCANO i ME Geen frames ee A mm LIVE 0410212012 08 12 46 Pullback Rate 0 5 mm sec amp 1 0 mm sec Manual Adjust Image Patient End Case a Archive F Retrieve Press Save Frame or Record Display Mode LIVE Ring Down OFF WH OFF Catheter Revolution Image Export ON Figure 3 Image On 505 0100 14 002 Page 13 of 22 Setting Pullback Speed The current pullback speed is indicated in the bottom of the ILD section You can change the pullback speed by selecting the radio button at the bottom of the ILD section on the system or by selecting the SpinVision PIMr button for the desired speed 0 5mm sec 1 0mm sec or Manual Using Time Gain Compensation TGC After selecting the Adjust Image button in the Home screen shown above the Time Gain Compensation TGC feature shown below increases or decreases the gain of the input signal with respect to distance from the transducer This feature is only available with the Revolution catheter Six TGC profiles are available Each can be adjusted to a user s need VOLCANO ESE cc tone como Y 06 04 2012 11 33 55 Time Gain Compensation Radius mm Display Mo
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