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300004969171/B 

 

Page 3 of 148 

 
 

Table of Contents 

PATENTS AND TRADEMARKS ................................................................................................................... 8

 

P

ATENTS

 ....................................................................................................................................................... 8

 

T

RADEMARKS

 ................................................................................................................................................. 8

 

WARNINGS AND PRECAUTIONS ............................................................................................................... 9

 

R

EAD AND 

R

EVIEW 

M

ANUAL BEFORE 

O

PERATION

 ................................................................................................. 9

 

F

OR 

U

SE ONLY BY 

T

RAINED 

M

EDICAL 

P

ERSONNEL

 ................................................................................................. 9

 

S

YSTEM 

U

SE 

C

AUTIONS AND 

W

ARNINGS

 ............................................................................................................. 9

 

PIM

 

U

SE 

C

AUTIONS AND 

W

ARNINGS

 ............................................................................................................... 12

 

C

ATHETER AND 

W

IRE 

U

SE 

C

AUTIONS AND 

W

ARNINGS

 ......................................................................................... 13

 

CHAPTER 1: OVERVIEW .......................................................................................................................... 14

 

I

NTRODUCTION

 ............................................................................................................................................. 14

 

I

NDICATIONS FOR 

U

SE

 .................................................................................................................................... 17

 

C

LINICAL 

A

PPLICATIONS

 .................................................................................................................................. 18

 

C

ONTRAINDICATIONS

 ..................................................................................................................................... 18

 

P

OSSIBLE 

A

DVERSE 

R

EACTIONS

 ........................................................................................................................ 18

 

CHAPTER 2: SYSTEM DESCRIPTION ......................................................................................................... 20

 

S

YSTEM 

O

VERVIEW

 ....................................................................................................................................... 20

 

M

ONITOR

 .................................................................................................................................................... 21

 

C

ONTROL 

C

ONSOLE

 ....................................................................................................................................... 22

 

J

OYSTICK 

C

ONTROLLER 

O

PTION

 ........................................................................................................................ 25

 

W

ORKSTATION 

(C

ENTRAL 

P

ROCESSING 

U

NIT

)..................................................................................................... 27

 

P

RINTER

 ...................................................................................................................................................... 27

 

C

ONNECTOR 

P

ANEL

 ....................................................................................................................................... 27

 

P

ATIENT 

I

NTERFACE 

M

ODULE

 .......................................................................................................................... 30

 

C

ATHETERS

 .................................................................................................................................................. 30

 

A

VAILABLE 

O

PTIONS

 ...................................................................................................................................... 31

 

CHAPTER 3: SYSTEM SETUP .................................................................................................................... 32

 

O

VERVIEW

 ................................................................................................................................................... 32

 

I

NSTALLATION

............................................................................................................................................... 32

 

T

URNING 

S

YSTEM 

ON .................................................................................................................................... 33

 

IVUS

 

S

OFTWARE 

S

ETTINGS

 ............................................................................................................................. 33

 

CHAPTER 4: PREPARING FOR A CASE ...................................................................................................... 44

 

O

VERVIEW

 ................................................................................................................................................... 44

 

E

NSURE 

S

YSTEM 

P

OWER IS 

O

N

 ........................................................................................................................ 44

 

C

ONNECT THE 

PIM ....................................................................................................................................... 45

 

E

NTER 

P

ATIENT 

I

NFORMATION

 ........................................................................................................................ 46

 

CHAPTER 5: ACQUIRING IVUS IMAGES ................................................................................................... 48

 

O

VERVIEW

 ................................................................................................................................................... 48

 

I

NSERT THE 

C

ATHETER

 .................................................................................................................................... 48

 

A

DJUST THE 

I

MAGE 

(

IF DESIRED

) ...................................................................................................................... 49

 

CHAPTER 6: RECORDING IVUS IMAGES .................................................................................................. 54

 

Содержание CORE Mobile

Страница 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 4 X 3 5 X...

Страница 2: ...ation 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...

Страница 3: ...OSSIBLE 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...

Страница 4: ...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...

Страница 5: ...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 OPERATIN...

Страница 6: ...R 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 CORRECTN...

Страница 7: ...s 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 al...

Страница 8: ...Page 8 of 148 300004969171 B Patents and Trademarks Patents See Patents www philips com patents Trademarks Trademarks are the property of Koninklijke Philips N V or their respective owners...

Страница 9: ...y 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 ade...

Страница 10: ...cted 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 achi...

Страница 11: ...t 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 medica...

Страница 12: ...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 du...

Страница 13: ...300004969171 B Page 13 of 148 Catheter and Wire Use Cautions and Warnings NOTE See the package insert for a complete description of product usage warnings and precautions...

Страница 14: ...rocedures 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...

Страница 15: ...des 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 im...

Страница 16: ...ely 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 o...

Страница 17: ...tic 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 ultrasoun...

Страница 18: ...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...

Страница 19: ...300004969171 B Page 19 of 148 This page is intentionally blank for pagination purposes...

Страница 20: ...ts of the Volcano system as well as the available options System Overview The Volcano system consists of the following main components Monitor Control Console set in Control Pocket Keyboard Workstatio...

Страница 21: ...54 Sharpness 8 Color Full Color Color Temp 7500 Table 1 Monitor Settings NOTE Default settings are manufacturer s suggested settings Manufacturing default settings can be restored by using the Menu b...

Страница 22: ...he monitor to allow function selection The trackball is also used for selecting annotation locations and making measurements Screen Selection Keys There are several screen selection keys on the Contro...

Страница 23: ...n the ChromaFlo feature on or off VH Turn VH Display when present on or off when VH data is available Record Record a video loop Stop Stop or end recording of a video loop pause while in live mode or...

Страница 24: ...ess Scroll once then move track ball up or down to navigate screen Press again to disable Select key Press to select tabs areas or measurement points It is similar to left clicking with a mouse Menu k...

Страница 25: ...ket Figure 7 Control Pocket Alphanumeric Keyboard A standard alphanumeric keyboard is located under the monitor and next to the control console and is used for data entry and image annotation Joystick...

Страница 26: ...roll and Measure Use the Select key to select options on the screen with the cursor It is similar to left clicking with a mouse Selecting the Scroll key allows you to enter scroll mode In this mode th...

Страница 27: ...nk cartridges can be ordered through Volcano or most major office supply stores The printer power switch located on the printer front panel see below is dedicated to ON OFF function of the printer onl...

Страница 28: ...Page 28 of 148 300004969171 B Figure 10 Connector Panel...

Страница 29: ...S SA PIM and SpinVision PIMr Twist lock CORE FM Push Pull Display Port Push Pull USB Push Pull Network connections for DICOM and Image Export Push and latch unlatch and pull ECG Aortic input connectio...

Страница 30: ...IM provides patient electrical isolation Figure 11 Patient Interface Module WARNING The PIM s cable may be damaged if equipment is rolled on it Do not pull on the cable place it where there is any tra...

Страница 31: ...nt interface module specific for Volcano s pressure wires Volcano CORE vid Scan converter offering composite and svideo outputs Joystick Controller Provides sterile field control for those who prefer...

Страница 32: ...to establish the desired settings Once set these settings will be maintained for each use You can change these settings at any time by following the instructions in this chapter Installation To ensure...

Страница 33: ...up messages before it is ready for use approximately two minutes Equipotentiality This symbol on the system rear electrical panel identifies the connector where the hospital room s potential equaliza...

Страница 34: ...M D Check Use 24 Hour Format to set the date using a 24 hour system Select the default boot up mode IVUS or FFR Choose to enable display all information boxes in which Do not display again was selecte...

Страница 35: ...ick Cancel to disregard selections Figure 13 Settings Image Defaults Acquisition Rate Tab The acquisition rate determines how many frames per second are recorded during a pullback and the duration of...

Страница 36: ...tions o Graticules Configure DICOM See Appendix C for more information Check Verify DVD box if you would like verification to be automatically performed for each archive Check the Auto Archived Case D...

Страница 37: ...plorer only applies to Eagle Eye catheter VH will display only if VH data is available Adjust the Default Opacity Levels for each tissue type This allows you to customize the relative prominence of ti...

Страница 38: ...Page 38 of 148 300004969171 B Figure 16 Settings VH IVUS Defaults...

Страница 39: ...tinue to move the cursor until the border is correct When BorderGuide is turned Off no preview border is generated as dots are placed Border Editing Mode Select whether border measurements are edited...

Страница 40: ...is advised to log off if the system is unattended or if switching users To Log off click the Select Mode button and then select Log Off To log on enter username and password Upon installation of v3 3...

Страница 41: ...istrator must select Disable Security and enter the username and password Add or delete a user o To add a user select Add User in the Account Management section Specify Account type as user or adminis...

Страница 42: ...2 of 148 300004969171 B o The administrator can also access a report that shows them information on the user and system activity o To access the report select View Report from the Account Management w...

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Страница 44: ...blem to expedite service Please contact Volcano technical support if an error is encountered NOTE 1 The printer controller and monitor will receive power once the power cord is connected to the approp...

Страница 45: ...terclockwise a quarter turn and then pull back CAUTION Use care when handling the PIM to avoid accidental dropping especially when a catheter is connected NOTE 1 Leave the power on during the case unl...

Страница 46: ...not start until the catheter is connected to the PIM Connect the ECG Input ECG input must be connected to the Volcano system in order to provide VH analysis for Eagle Eye catheter VH IVUS is only ava...

Страница 47: ...ings select the patient from the worklist Press the TAB key to move forward from one field to another To move backward press the SHIFT TAB keys simultaneously Clear Form will remove all information fr...

Страница 48: ...t using standard intra operative or percutaneous techniques by suitably trained physicians The frequency and duration of administration is subject to the discretion of the physician and depends upon t...

Страница 49: ...settings can be adjusted based on your preferences Once set specific values persist until changed To change the settings press the Adjust Image button The Adjust Image dialog appears at the bottom of...

Страница 50: ...for the system catheter is VH Display Off Activating ChromaFlo The ChromaFlo option uses patented technology to provide a visual depiction of blood flow through the vessel It accomplishes this by over...

Страница 51: ...ual in the Settings dialog box Press the Ringdown key on the control panel to start the ringdown reduction press the Ringdown key again to stop the manual ingdown reduction NOTE Whenever a new cathete...

Страница 52: ...e the up and down arrows to increase or decrease the Gain setting The ultrasound image will become brighter or darker according to the setting Catheter Type Gain Range Default Gain Eagle Eye Gold 1 68...

Страница 53: ...P 8 20 mm 2 Visions PV 018 10 24 mm 2 Visions PV 035 20 60 mm 5 To change the diameter 1 Open the Adjust Image dialog box Figure 23 Adjust Image Dialog Box Diameter 2 In the Diameter box use the up an...

Страница 54: ...adjusting the image settings Overview Images can be recorded by either saving a single frame Save Frame or recording a video loop of multiple frames Recording a Video Loop Prior to recording select th...

Страница 55: ...elected WARNING Incorrect measurements will be obtained if the Pullback Rate is incorrect 2 Position the catheter distal to the area to be imaged 3 Press the Record Loop button Collected data is displ...

Страница 56: ...real time image is stored and labeled starting with F1 The frame may be viewed in either grayscale or VH mode 2 Press Save Frame again to store another image as F2 and so on A maximum of 99 frames ca...

Страница 57: ...of all the video loops and saved frames for the open case Use this list to select the images that you would like to review The list displays when the cursor is positioned over the Case Explorer bar lo...

Страница 58: ...uch as gain pullback rate etc Pullback Rate view or edit the pullback rate for the currently displayed video loop Expand display sub menu items Collapse hide sub menu options Cancel exit from properti...

Страница 59: ...layback The Play key or green button resumes playback Rapid Review Feature The Rapid Review feature allows you to quickly view a select number of frames proximal and distal to a frame of interest This...

Страница 60: ...can be selected for review using the Case Explorer or by using the Bookmark up down arrows located at the bottom of the ILD Figure 29 Review Toolbar Navigate Bookmarks Full Pulback ILD Display Compres...

Страница 61: ...igure 31 ILD Features The navigation marker tabs are on the right side of the ILD display White the current frame marker The frame number displays in the marker Green the first frame of the segment of...

Страница 62: ...frames were captured the scroll bar would be quite small but if only 600 frames were captured the scroll bar would be larger than half the scroll box Creating a Segment of Interest A segment of intere...

Страница 63: ...pear in the center 2 Press the Select key to rotate the arrow in the counterclockwise direction alternately press the Menu key to rotate the arrow 10 degrees in the clockwise direction 3 Continue clic...

Страница 64: ...ion for printing an image as a report The ILD and navigation buttons are not displayed in this view All of the functions from the control console such as live record bookmark etc are available in this...

Страница 65: ...OTE 1 An approximate five second delay occurs between pressing the Print button and printer activation NOTE 2 Replacement paper and ink cartridge kits can be ordered through Volcano Corporation or at...

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Страница 67: ...a Dot or Draw Vessel Length within the ILD To Enter Measurement Mode 1 Navigate to Home screen 2 Locate the frame of interest for example Saved Frame Frame within a video loop loop must be stopped Fro...

Страница 68: ...left corner of the image 5 To change a line press Select on the end you wish to move and drag it to the new position Press Select again to anchor it 6 To delete a line click the red Delete button Mov...

Страница 69: ...place each dot and move the cursor to place another dot a preview border is drawn If the border is correct press select to lock the dot and border in place If the border is not correct continue to mo...

Страница 70: ...order becomes a dashed line 2 There are two ways to edit i In Draw edit mode the user can click on the area measurement line and begin to draw the border contour To finish click the Select button ii I...

Страница 71: ...Select NOTE There is no undo for deleting an area measurement Measuring Vessel Length NOTE Measure vessel length in the ILD only if a non manual pullback rate has been selected If the video loop was o...

Страница 72: ...length 1 Click the Diameter button 2 Using the trackball move the cursor into the ILD and press Select to anchor the first point 3 Move the cursor to the desired end point and press Select again to an...

Страница 73: ...ce it where you want the annotation 5 To edit an annotation move the cursor over the annotation and press Select Edit the annotation and press Select again 6 To reposition the annotation press Select...

Страница 74: ...mula is used to calculate percent difference Difference 1 Target Lumen Area Reference Lumen Area To calculate percent difference between frames Navigate to the first frame of interest and make an area...

Страница 75: ...ent then press Select once it is highlighted o Edit as needed o Click on the lock icon again to lock in the new measurement o The percent difference calculation will now be updated To delete a percent...

Страница 76: ...identify what type of plaque is present The VH IVUS software is capable of differentiating four tissue types from the radio frequency RF data All elements with the plaque boundaries as defined by the...

Страница 77: ...300004969171 B Page 77 of 148 Activating VH Display Select the VH button on the control console to enable or disable VH display feature The default setting is VH off Figure 42 Control Console...

Страница 78: ...tatistics on the screen Click the Visibility box to display the borders and or VH IVUS Click the frame or segment box to display the statistics of your choice Move the slider bar to increase or decrea...

Страница 79: ...on the border and begin to draw the border contour To finish click the Select button ii In Dot edit mode the user can move the border by clicking in a new location To end editing double click the Sele...

Страница 80: ...that in this mode the autoborders will be adjusted so that the inner border is fixed right around the transducer perimeter NOTE It is recommended to consult with your local Volcano representative pri...

Страница 81: ...Select the target assist button The yellow bar will select the smallest Minimum Lumen Area MLA 3 Click on the label to display statistics Move the MLA bar to any frame and the label will change to Tar...

Страница 82: ...to yellow color scale in the image area The ChromaFlo processor detects flow of particles red blood cells perpendicular to the imaging plane or along the long axis of the catheter This is unlike conv...

Страница 83: ...ing areas of blood flow Use the up and down arrows located in the Adjust Image screen to adjust the sensitivity value Setting the Region of Interest Setting the Region of Interest restricts the flow d...

Страница 84: ...he diameter by approximately 0 52 mm with a tolerance of 0 03 mm Deactivating the ChromaFlo Feature To deactivate the ChromaFlo feature press the Chroma key on the control console or open the Adjust I...

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Страница 86: ...case to the system s hard drive Alternatively you may choose to delete the case NOTE If power is shut off before ending a case restart the system When the system restarts the End Case screen displays...

Страница 87: ...ing to end a case when the limit of 20 cases is exceeded on the hard drive the opened case cannot be saved Select the Auto Archive Case Deletion in the settings menu to automatically delete the oldest...

Страница 88: ...not read legacy DVDs or CDs from Invision Only use HIGH QUALITY DVD Rs Minimum 8X NOTE FFR data may be stored on DVDs or CDs and used on this system What Data is Archived The data you entered in the...

Страница 89: ...uch data remains to be transferred NOTE The archived images are stored in DICOM format with Volcano system acting as a File Set Creator FSC following the guidelines in the 2004 DICOM 3 0 specification...

Страница 90: ...on a different system or computer the potential for data corruption exists Archiving Using DICOM DICOM stands for Digital Imaging and Communications in Medicine It is an image format for medical imag...

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Страница 92: ...efore switching modes Switching Modes You can switch from one modality to another by clicking on the Select Mode button shown below Once selected a menu of available modes is presented Click on the mo...

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Страница 94: ...previously been ended to review and or edit case data Cases can be retrieved from System Hard Drive DVD NOTE Cases cannot be retrieved from the DICOM Network In addition instructions are provided for...

Страница 95: ...it The case is highlighted 4 Press the Start Retrieve button to transfer the data from storage to the Volcano system A bar on the screen indicates the progress of the data retrieval NOTE You can retr...

Страница 96: ...Page 96 of 148 300004969171 B Removing Power from System 1 Turn off system power 2 Unplug the system at the appliance power inlet wall socket 3 Do not block accessibility to the appliance power inlet...

Страница 97: ...ap resides on the Siemens system Please reference instructions for use in the IVUSMap section of the Siemens manual When this feature is enabled on the Volcano system registered IVUS images are sent t...

Страница 98: ...rtis and Volcano system the right bottom corner of the Status Bar shows Image Export ON Figure 54 Patient Information Image Export ON b If Image Export is enabled but there is no active connection bet...

Страница 99: ...ondition for the catheter in use The message disappears approximately two seconds after the catheter has been unplugged from the PIM or when the high power condition is corrected Replace the catheter...

Страница 100: ...Wait for 1 minute before powering up again The Meridian could not restart the VH and IVUS boards back to Meridian Mode Failure to start either the VH or IVUS board after switching back from FFR to IVU...

Страница 101: ...rive There is a problem with the hard drive Contact Technical Support Error retrieving patient case There is a problem with the hard drive Contact Technical Support Retrieve from DVD failed There is a...

Страница 102: ...ile Reboot the system and try again If problem persists call Technical Support Internal Error NeroAPI DLL Not Found Missing Valid Nero Serial Number Bad Nero Serial Number Error obtaining Available Dr...

Страница 103: ...Segment Specified Target Assist does not work with VH video loops with only one frame Create another VH video loop with more than one frame Try Target Assist again If problem persists call Technical S...

Страница 104: ...hooting chapter of the Volcano system Revo Option Operator Manuals 807470 002 Potential Imaging Artifacts Adaptive Ringdown Reduction Adaptive NearVu Artifact Cause Resolution Image Artifacts appears...

Страница 105: ...e blanking and more importantly to prevent restricted blood supply it is very important to avoid situations where the transducer is barely moving and completely wedged for a prolonged period in a heav...

Страница 106: ...n flow below this velocity will appear as black Carefully identify and compare the lumenal boundary based on grayscale images with those obtained from ChromaFlo images as well as other modalities such...

Страница 107: ...readings near the transducer Move the catheter to another location Potential Imaging Artifacts Automatic Distance Measurement Artifact Cause Resolution Automatic Distance Measurement is not proper The...

Страница 108: ...nal irregularities are due to catheter motion or actual lumen variations Note that the vessel wall boundary or the media to adventitia interface changes slowly as the catheter is moved axially Cathete...

Страница 109: ...disposal when decommissioning the unit 1 Power down the workstation and unplug the unit 2 Open the workstation side panel to access the interior of the unit 3 Remove the coin battery from the motherb...

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Страница 111: ...nel or by Volcano certified technical representative Maintenance Frequency User Performed Maintenance Frequency Archive patient cases Daily as used Clean components in patient vicinity Daily as used C...

Страница 112: ...e the solution used is active against HIV virus and hepatitis B virus Do not use solvents to clean any portion of the system Avoid allowing liquids to enter the system openings especially the keyboard...

Страница 113: ...C Cooling Fan Filter Maintenance Check workstation PC fans and filter monthly and clean every 18 months to help ensure optimal cooling NOTE The system should be turned off and unplugged from wall outl...

Страница 114: ...front fans clean with a vacuum 6 Replace fan covers by aligning the cover holes with case pins and press covers onto case pins To clean the rear panel fan 1 Open the rear chassis door of the workstat...

Страница 115: ...nector and ensure cable is protected from accidental damage Inspect cable connections to ensure secure connections Volcano Certified Maintenance Volcano certified maintenance is performed by Volcano c...

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Страница 117: ...Platinum ST Short Tip 20 MHz 8 10 12 14 16 18 20 Visions PV 014P 20 MHz 8 10 12 14 16 18 20 Visions PV 018 20 MHz 10 12 14 16 18 20 22 24 Visions PV 035 10 MHz 20 25 30 35 40 45 50 55 60 Revolution 45...

Страница 118: ...Page 118 of 148 300004969171 B Image Live Still modes Variable frame rate 360 image Multiple depth scaling Image Sizes Image Mode Image Area in pixels Max IVUS 750 x 750 Normal Imaging Mode 500 x 500...

Страница 119: ...h in Depth in Weight lb CORE Mobile Cart 62 22 33 210 Height cm Width cm Depth cm Weight kg CORE Mobile Cart 157 48 55 88 83 82 95 25 Power Volcano Ratings and Fusing SystemInput Configurations Workst...

Страница 120: ...1000 4 4 EFT level3 EN61000 4 5 Surge level3 EN61000 3 2 Harmonics EN61000 3 3 Flicker EN61000 4 11 Voltage dips short interruptions EN55011 conducted an radiated emissions Fusing The Isolation Transf...

Страница 121: ...al Device Directive 93 42 EEC as amended by 2007 47 EC These limits are designed to provide reasonable protection against harmful interference in a typical medical installation This equipment generate...

Страница 122: ...console and workstation Environmental Conditions Temperature o F Temperature o C Relative Humidity non condensing Altitude ft Altitude m Operating 50 to 104 10 to 40 5 80 10 000 3 048 Storage 4 to 158...

Страница 123: ...olcano system is 1 0 3 C above ambient temperature in air and 38 0 3 C under physiologic conditions 37 C in fluids Operation of the catheters in air will degrade the life of the catheter and is not re...

Страница 124: ...r only when initiated by the operator Ultrasound output power settings are automatically maintained at preset and safe levels during imaging operations Electrical safety is maintained in all operation...

Страница 125: ...Inc Acoustic Output Parameter B Mode ChromaFlo ISPTA 3 mW cm2 1 2 683 20 800 ISPPA 3 W cm2 1 0 248 1 870 Pr 3 MPa 2 137 1x10 3 315 3x10 3 PD s 2 201 2x10 3 125 0x10 3 PRF Hz 53760 88320 Center Freq MH...

Страница 126: ...3x10 3 113 8x10 3 PRF Hz 43008 70656 Center Freq MHz 2 20 20 MI2 3 055x10 2 5 306x10 2 TI1 2 698x10 4 4 748x10 4 1 Uncertainty 33 9 30 5 2 Uncertainty 17 0 15 3 Visions PV 035F Acoustic Output Parame...

Страница 127: ...a W0 Total Power mW PD Pulse Duration s PRF Pulse Repetition Frequency Hz Measurement Accuracy Measurements obtained with the Volcano system are subject to the following measurement inaccuracies due t...

Страница 128: ...00004969261 CD Volcano CORE Mobile Operator s Manual N A 804390001 Large Size 144mm x 100mm A6 Paper for Sony UP 25MD 4 packs of 50 sheets N A 431 0100 01 Small Size 100mm x 90mm A6 Paper for Sony UP...

Страница 129: ...SI AAMI ES60601 1 2005 A2 R2012 A1 IEC 60601 2 37 2007 IEC 60601 2 34 2011 CAN CSA C22 2 No 60601 1 14 The Volcano system FFR Option does not comply with Clause 51 102 1 since the guide wire s pressur...

Страница 130: ...ore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class A Volcano System Family is suitable for use in all establishme...

Страница 131: ...fter immunity testing the system shall continue to function and accept the commands given by user It can temporarily lose communication but must return to normal operation without being disconnected I...

Страница 132: ...gnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Volcano System Family is used exceeds th...

Страница 133: ...ironment Surge IEC 61000 4 5 0 5 1 kV line s to line s 0 5 1 2 kV line s to earth 0 5 1 kV differential mode 0 5 1 2 kV common mode Mains power quality should be that of a typical commercial or hospit...

Страница 134: ...he Volcano System Family be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at lev...

Страница 135: ...2 EEC Power Off Power On Warning Attention Consult Accompanying Documents Power On Off Laser Warning Attention Consult Accompaying Documents Patient Interface Module PIM Connector Output Signal Equipo...

Страница 136: ...tention observe precautions for handling electrostatic discharge sensitive devices Recycle Humidity Limitation Atmospheric Pressure Limitation Temperature Limitation Follow Operating Instructions Foll...

Страница 137: ...image Measurements annotations and retrieving and clearing data are examples of post processing Ringdown Artifact Ringdown artifact is a result of multiple phenomena such as acoustic and RF signal cr...

Страница 138: ...of all four composition types Lumen dia min smallest minimum diameter within this frame Lumen dia max largest maximum diameter within this frame Lumen dia avg average diameter within this frame Vesse...

Страница 139: ...ent This measurement occurs at the frame number displayed Vessel dia max largest diameter measurement within the defined segment This measurement occurs at the frame number displayed Vessel dia avg av...

Страница 140: ...urs after excising the LAD vessel Each artery was dissected from the ostium to the apex including approximately 40 mm of surrounding fat and myocardial tissue Inclusion of surrounding tissue ensures t...

Страница 141: ...ROI and corresponding backscatter spectral properties that were determined from the IVUS data VH Algorithm Evaluation The algorithm developed above from the set of homogenous ROIs was used to create...

Страница 142: ...ification tree by tissue type Tissue Type Number of Evaluation Regions Predictive Accuracy Sensitivity Specificity Fibrous Tissue 471 93 5 95 7 90 9 Fibro Fatty 130 94 1 72 3 97 9 Necrotic Core 132 95...

Страница 143: ...ork Configuration dialog box displays as shown below Figure 58 DICOM Settings Local Host Dialog Box NOTE After changing the Local Host settings you need to power down the system for the new settings t...

Страница 144: ...itch to an active port Apply Select Apply button to apply any setting changes LocalHost DICOMSCUSettings Storage AE Title The Application Entity Title field is used to configure the AE title for the l...

Страница 145: ...Network operation New Server This field is used to enter the name of a new DICOM Server This is a user friendly alias used to identify a remote DICOM Storage Server Once the name is typed pressing eit...

Страница 146: ...the host name and IP Address are entered then the IP Address is used for the PING instead of Host Name resolution StorageServers DICOMSCPSettings AE Title This field is used to configure the Applicat...

Страница 147: ...s US Modality When checked images will be transferred to remote storage servers using the US Modality When unchecked images are transferred using the IVUS Modality Worklist Servers Configuration This...

Страница 148: ...the each defined Remote DICOM Storage SCP Server Host name Computer Host name of the remote device IP Address IP Address of the remote device Find Performs a network PING to determine in the configur...

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