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Technical Specifications

ACIST RXi System User’s Guide |

901700-001,01 2019-09 English

Clinical Guidance for Use of Pd/Pa to FFR Measurements

As stated previously, the ACIST RXi System is designed to provide

hemodynamic information for the diagnosis and treatment of coronary and

peripheral artery disease. The system is intended for use in catheterization and

related cardiovascular specialty laboratories to compute and display fractional

flow reserve (FFR) and resting Pd/Pa.
The expected FFR value in a normal vessel without a stenotic lesion or

obstruction to blood flow is a value of 1.0. Based on clinical evidence, a

threshold or cutpoint value of ≤ 0.80 is commonly considered for treatment

with a therapeutic intervention, while a value > 0.80 is commonly considered

for deferment. An established, clinically evident Pd/Pa threshold or cutpoint

such as this is indeterminate, but guidance for use of Pd/Pa for clinical

decision making may be considered by referring to the existing, supportive

clinical evidence from multiple diagnostic accuracy studies performed on

resting Pd/Pa.
A recent meta-analysis was reported by Maini et al., based on published

resting Pd/Pa diagnostic accuracy studies

which examined the overall

diagnostic accuracy of Pd/Pa compared to FFR. The meta-analysis reported on

14 studies with an optimal cutpoint ranging from 0.875 to 0.96 and resulted in

cutpoints from 0.91 to 0.93 in 12 of the 14 studies in the meta-analysis.
The ACIST-FFR Pd/Pa Post-hoc Sub-Group Analysis

identified an optimal

cutpoint of 0.91. The cutpoint was derived from a post-hoc receiver operating

characteristic (ROC) curve analysis using an FFR cutoff value of ≤0.80

measured with the ACIST Navvus® MicroCatheter to define stenosis. The 0.91

cutpoint is within the range of 0.91 to 0.93 as was reported in 12 of the 14

studies in the Maini et al., meta-analysis.
Clinical Guidance for use of FFR and Pd/Pa physiologic measurements

by the physician may be considered as the resting Pd/Pa value, along with

patient history, medical expertise and clinical judgement to determine if an

additional measurement of FFR during hyperemia or therapeutic intervention

is indicated.

1. Maini R, Moscona J, Sidhu G, Katigbak P, Fernandez C, Irimpen A, Mogabgab O, Ward

C, Samson R, LeJemtel T.

Pooled diagnostic accuracy of resting distal to aortic coronary

pressure referenced to fractional flow reserve: The importance of resting coronary

physiology.

J Interv Cardiol.

2018 Oct; 31(5): 588-598.

2. Thackery, Lisa.; Rorke, Becky; Larson, Janet A. Post-hoc analysis of data from the

ACIST-

FFR clinical study which assessed catheter based interrogation and standard techniques

for Fractional Flow Reserve Measurement.

Original data set analysis published in:

Circ

Cardiovasc Interv.

2017 Dec; 10 (12). e005905.

Clinical Guidance

for Use of Pd/Pa

to FFR

Measurements

Содержание RXI

Страница 1: ...User s Guide ACIST RXi Rapid Exchange FFR System Bracco Group 901700 001 01 2019 09 English ...

Страница 2: ... Inc 2019 ACIST Medical Systems Inc All rights reserved The written and graphic product descriptions in this manual were effective at the time of printing ACIST Medical Systems Inc reserves the right to change specifications and designs without prior notification ACIST ACIST RXi and NAVVUS are registered trademarks of ACIST Medical Systems Inc Contact Information Web site worldwide acist com USA A...

Страница 3: ...emOverview 11 System Hardware 11 System Console 13 System Power Supply 13 Touchscreen User Interface 14 Purpose of the Touchscreen 14 Navvus MicroCatheter 16 4 Installation 17 Unpacking 17 Preliminary Inspection 17 Package Contents 17 Installation Precautions 18 Installation Procedures 19 Mount the ACIST RXi System on a Bed Rail 19 Mounting the ACIST RXi System to the ACIST CVi Injector with the P...

Страница 4: ...s and Enter Venous Pressure 37 Equalize Signals and Adjust Pv 37 Detection of Broken Navvus MicroCatheter 40 Record the FFR for the First Vessel 41 Record 41 Record the FFR for Another Vessel 44 Review the Case Summary and Export Data 44 New Vessel 44 Case Summary 44 Shutting Down the ACIST RXi System 45 Power Off 45 6 SystemInformationandSettings 47 About the ACIST Menu 47 System Information 49 S...

Страница 5: ...onal Settings 67 Define a Vessel ID using the New Vessel Button 67 Review the Case Summary 70 Review the FFR Recording FFR Review 71 Zero the Aortic Pressure 72 Adjust the Venous Pressure 73 7 Maintenance 75 Cleaning and Maintenance 75 Prevent Equipment Damage 75 DecontaminationProcedure 76 Daily Cleaning 77 Optional Fiber Optic Cleaning Process 78 Monthly Inspection and Maintenance 80 8 Troublesh...

Страница 6: ...R Measurements 99 EMC Tables 100 Guidance and Manufacturer s Declaration Electromagnetic Emissions 100 Guidance and Manufacturer s Declaration Electromagnetic Immunity 101 Criteria Definitions 103 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the ACIST RXi System 103 11 LimitedWarranty 105 12 Appendix AoInterfaceBox 107 Package Contents 107 Device Des...

Страница 7: ...nt s anatomy and health status The ACIST RXi System is designed to provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve FFR and resting Pd Pa FFR and resting Pd Pa supplements the visual data provided...

Страница 8: ...ibes the system components and functions 4 Installation Instructions Explains how to install the system 5 Basic Operating Procedures Provides instructions for preparing and using the RXi System for obtaining FFR recordings during angiographic procedures 6 System Information and Settings Provides instructions for reviewing system information and changing system settings 7 Maintenance Provides instr...

Страница 9: ...llowing conventions Note Notes are used to highlight important information from the rest of the text CAUTION Cautions alert the user to a possible hazard that may result in equipment damage or personal injury WARNING Warnings alert the user to a possible hazard that may cause serious injury or death Manual Conventions ...

Страница 10: ...4 ACIST RXi System User s Guide 901700 001 01 2019 09 English Introduction This page intentionally left blank ...

Страница 11: ...terile drape Prior to use and whenever possible during the procedure carefully inspect the Navvus MicroCatheter for kinks or any other damage Do not use a kinked or damaged microcatheter as vessel damage and or the inability to advance or withdraw the microcatheter may occur The Navvus MicroCatheter is supplied sterile in a protective carton containing a sterile barrier tray Sterility is indicated...

Страница 12: ...emoved and replaced If the system is set to Stationary mode and you move the system from one lab to another you must manually zero the RXi aortic pressure after you zero the hemodynamic monitoring system or an incorrect FFR or resting Pd Pa value may result To prevent electric shock always turn off power to the system and disconnect the power cord from the main power source before performing any c...

Страница 13: ...p be used to power the system Connect only to certified hemodynamic systems that have no more than 36 VDC output voltage Ensure aortic pressure is correctly set to zero on the ACIST RXi System Always verify that the Pa value is zero Only qualified medical professionals may use the ACIST RXi System User vigilance is required at all times when using the system To avoid inaccurate arterial pressure m...

Страница 14: ...th the stopcock at the midaxillary position zero the hemodynamic transducer at the start of each patient case by using atmospheric pressure as a zero pressure reference Zeroing the transducer ensures that the pressure values measured are only from within a blood vessel or from within the heart Periodically re zeroing the transducer ensures the continued accuracy of blood pressure readings If hemod...

Страница 15: ... separately With respect to electrical shock fire mechanical and other specified hazards only in accordance with IEC 60601 1 second and third editions Do not use if package is damaged and consult instructions for use Do not re use Do not re sterilize Quantity Use by date Sterilized using ethylene oxide IPX0 IEC 60529 European ECC Water Protection Specifications Direct Current 5031 Class II equipme...

Страница 16: ...ooklet Caution Federal law USA restricts this device to sale by or on the order of a physician Non pyrogenic LATEX Not made with natural rubber latex Fragile handle with care Connector 1 for the BNC connector on the RXi Ao input cable Connector 2 for the cath lab invasive blood pressure transducer cable Connector 3 for hemo system cable MR unsafe MD Medical device Single sterile barrier system Sin...

Страница 17: ...mputes the FFR value power supply attaches to the mounting post and provides power to the system console one of two mounting systems that supports the system console Stationary Mount System that attaches to the bed rail Pivoting Mount System that attaches to the ACIST CVi Injector Stationary Mount System that attaches to the bed rail System Console Adjustable Mounting Post Power Supply System Hard...

Страница 18: ...ystem User s Guide 901700 001 01 2019 09 English System Overview Pivoting Mount System that attaches to the ACIST CVi Injector The system hardware also includes the following power and communication cables hemodynamic monitor cables ...

Страница 19: ...ults hemodynamic cable ports power cable System Power Supply The power supply which provides power to the ACIST RXi System is the only connection to mains power A green system status indicator light illuminates when power to the system is on and ready for use CAUTION Use only the supplied medical grade power converter Model MENB1030A1249F02 to ensure safe operation of the RXi System Color Touchscr...

Страница 20: ... aortic pressure signal equalizes the RXi pressure sensor and aortic pressure signals adjusts the Pv value displays the mean Pa Pd Pd Pa and FFR values identifies the vessel shows the last three FFR recorded values enables access to system settings via a main menu enables viewing the case information calibrates the RXi Pa signal to the hospital s hemodynamic system signal The following example of ...

Страница 21: ...ero aortic pressure Press Equalize to equalize the pressure sensor to aortic pressure Press Pv to enter the Pv value The default is zero Press Case Summary to display the case summary This area displays the minimum value of the last three FFR recordings The Vessel ID field is used to select and display a vessel name from a pop up list with 18 pre defined vessel names or to enter a custom vessel ID...

Страница 22: ...e with 0 014 in guidewires in the arterial vasculature The pressure sensor utilizes optical sensing technology A single connection between the Navvus MicroCatheter and the ACIST RXi System incorporates the optical connection An electrical interface provides sensor specific calibration information The sensor pressure signals are processed by the ACIST RXi System console which displays Pd Pa FFR Pa ...

Страница 23: ... Contents The ACIST RXi System is shipped in one box The individual packages within that box contain the following items Package 1 contains the system console power supply and cable and a literature reference card Package 2 contains the mount and hardware and a hook and loop fastener strap Package 3 contains accessories hemo system input and output cables Note This user s guide is supplied using a...

Страница 24: ...for assistance CAUTION Mains power quality should be that of a typical commercial or hospital environment To ensure that the RXi System remains operational during power mains interruptions ACIST recommends that an uninterruptible power supply or battery backup be used to power the system Before beginning installation perform the following steps Review possible mounting locations to ensure that the...

Страница 25: ...b ID optional How to perform Pa Scaling adjusting the aortic pressure value to match the value on the hemodynamic system Mount the ACIST RXi System on a Bed Rail To mount the ACIST RXi System on a bed rail 1 Attach the power supply to the bed rail mounting post Use the hook and loop fastener strap to secure the power supply as shown below 2 Ensure that the system console is securely attached to th...

Страница 26: ...rn the lower knob clockwise to tighten the brackets on the bed rail as shown in Figure B Figure B Figure A 4 Ensure that the mounting post is securely fastened on the bed rail 5 Use the vertical and horizontal adjustment knobs to customize the orientation of the system unit on the bed rail 6 Connect the power supply cable to the system console 7 Connect the power cord to an AC mains power source T...

Страница 27: ...CIST RXi System onto the ACIST CVi Injector with or without the optional extension arm as shown below To mount the ACIST RXi console on an ACIST CVi Injector 1 Connect the pivot bracket to the ACIST RXi console with four Phillips head screws Ensure that the pivot bracket is securely fastened to the console 2 If using the optional extension arm insert it into the pivot bracket and turn the knob on ...

Страница 28: ... adapter pin in the display arm socket on the Injector ensuring that the notch in the pin is properly aligned and the adapter pin is fully seated in the socket 4 Attach the pivot bracket or the optional extension arm to the adapter pin 5 Turn the knob on the pivot bracket or the extension arm clockwise to tighten ...

Страница 29: ...e switch on the right side of the unit to turn on the ACIST RXi System Confirm that the front right green LED is illuminated 3 Connect the RXi aortic pressure cable to the analog output port on the hemodynamic system as shown below The hospital s system may be different than the one shown here Note Ensure that you have the correct aortic pressure cable for the hospital s hemodynamic system CAUTION...

Страница 30: ... each new patient case 5 Optional You may connect the RXi pressure output cable to an available pressure input on the hemodynamic system Note This connection is not required but it allows you to view and record the pressure waves on the hemodynamic system The hospital s system may be different than the one shown here Note Ensure that you have the correct pressure output cable for the hospital s he...

Страница 31: ...ary position open the stopcock to expose the hemodynamic sensor to atmospheric pressure at the patient midaxillary position Zero the hemodynamic monitor Zero the aortic pressure on the ACIST RXi System 1 When the following status message appears on the touchscreen press Zero Aortic Zero Aortic Pressure Press Zero Aortic at the system prompt 2 Verify that the aortic signal Pa is showing zero 0 in t...

Страница 32: ...in the case summary and in the exported case summary You may enter or change the Facility Name and Lab ID information at any time but ACIST Medical Systems recommends that you do this during system installation Instructions for using these options are provided in Section 6 System Information and Settings Refer to page 54 for instructions on entering or changing a Facility Name Refer to page 56 for...

Страница 33: ...values are equal or within 1 mm Hg it is not necessary to perform this procedure Note The signal from the hemodynamic system must be something other than zero before this procedure can be performed If the transducer has a backplate that creates a steady test pressure use this to artificially apply a steady test pressure of 100 mm Hg This is preferable to using a live pressure However if unable to ...

Страница 34: ...01 01 2019 09 English Installation Note If the Pa value on the RXi system no longer equals the value on the hemodynamic system this procedure must be repeated Note If the RXi System is connected to a different hemodynamic system this procedure may need to be repeated ...

Страница 35: ...scussed in Section 7 Maintenance As an option use the system settings to adjust the system to specific parameters Refer to Section 6 System Information and Settings for more information If used in a sterile field ensure that the ACIST RXi System console is draped with a sterile barrier CAUTION Ensure aortic pressure is correctly set to zero on the RXi System Always verify the Pa value is zero on t...

Страница 36: ...curely attached on the bed rail or an ACIST CVi Injector 2 Turn on the system Facing the RXi console use the switch on the right side of the unit to turn on the ACIST RXi System ON power Off power The green system status indicator LED located on the console s front right side shows that power is on Power ON OFF Switch System Status Indicator LED 3 Wait approximately 30 seconds for the system to st...

Страница 37: ...rtic pressure signal before each case With the hemodynamic monitor still reading zero re zero the RXi aortic pressure if necessary If using the Mobile setting for the Lab ID as described on page 55 Press the Zero Aortic button If zeroing was previously performed the system confirms the action by displaying the following message Do you want to zero the aortic pressure Press OK Note If the Ao Interf...

Страница 38: ... associate a Patient ID with the case provide a Patient ID using the ACIST menu For detailed instructions refer to Enter a Patient ID on page 64 Vessel ID Provide a Vessel ID to identify the vessel being examined For detailed instructions refer to Define a Vessel ID using the New Vessel Button on page 67 Identify the Patient ID and the Vessel ID for the Case ...

Страница 39: ...the dispenser coil and catheter sterile saline solution CAUTION To avoid inaccurate aortic pressure measurements the use of guide catheters larger than 8F or guide catheters with side holes are not recommended Avoid blocking blood flow to the selected artery Do not wedge the guide catheter in the selected artery WARNING Prior to use and whenever possible during the procedure carefully inspect the ...

Страница 40: ...with your fingers b Hold the tray securely with your left hand and use your right hand to peel thecover back and off the tray c Present the opened tray to the scrubbed and sterile physician Continue to hold the opened tray for the scrubbed and sterile physician until the product is removed from the tray as described below M P S Physician Technician d Grasp the purple handle assembly e Using the sa...

Страница 41: ... Navvus MicroCatheter pressure sensor is automatically zeroed when the handle assembly is inserted into the ACIST RXi System console Therefore the tip should be outside the patient when this handle assembly is inserted into the system console Once inserted do not remove the Navvus MicroCatheter from the system throughout the procedure The Navvus MicroCatheter status indicator LED illuminates GREEN...

Страница 42: ...que attach a new sterile hand syringe filled with sterile saline solution to the flushing Luer entry port of the dispenser coil Thoroughly flush the Navvus MicroCatheter 10 Using sterile technique remove the Navvus MicroCatheter from the dispenser coil and inspect it for any damage or kinks If damage or kinks exist discard the microcatheter and use another ...

Страница 43: ...ter on the guide catheter after placing the Navvus MicroCatheter distal shaft inside the guide catheter or false low aortic pressure readings may result Open the hemostasis valve fully to avoid damage to the Navvus Catheter tip Do not perform high pressure greater than 600 psi fluid injections while the Navvus MicroCatheter tip is inside the guide catheter Observe all Navvus MicroCatheter movement...

Страница 44: ...G Do not disturb pressure sensing system elements during equalization or FFR recording 6 Equalization must take place with the Navvus MicroCatheter distal tip just distal to the guide catheter tip Pressure is measured less than 3 mm proximal from the marker band that is visible under fluoroscopy Flush the guide catheter with saline solution Verify that the Pa displayed on the ACIST RXi System matc...

Страница 45: ...al flow reserve Pd is the mean arterial pressure distal to the stenosis as measured by the Navvus MicroCatheter Pv is the systemic venous pressure Pa is the mean aortic pressure at the ostium High venous pressure above 8 mmHg will have a significant impact on FFR and resting Pd Pa values A high Pv value results in lower FFR and resting Pd Pa values To change the venous pressure value perform these...

Страница 46: ...laced The Catheter Malfunction alarm distinguishable from all other system information signals sounds immediately and consists of a series of repeated tones at a maximum volume of 80 dB 5 Other auditory signals are a single short pulse at low volume Simultaneously the following flashing message is displayed Warning Catheter malfunction detected Stop procedure immediately and replace catheter with ...

Страница 47: ...ected 3 With the Navvus MicroCatheter tip still present just outside the guide catheter tip ensure the Pa and Pd values are equal Pd Pa 1 00 4 To properly position the pressure sensor carefully advance the Navvus MicroCatheter until the marker band at the distal tip is 1 2 cm distal to the lesion being evaluated Note When performing a resting Pd Pa assessment the live resting Pd Pa value is availa...

Страница 48: ...played on the FFR Review screen Refer to page 71 for details regarding this screen The system has pre selected the minimum FFR value present in the recording Use the scrolling arrows on either side of the screen to shift the position utilized for the minimum FFR value Use the Revert button to return to the system selected value 8 Press either Discard or Save If you press Discard the system permane...

Страница 49: ...nging the vessel You can save recordings for a maximum of 10 vessels per case The oldest saved recording will be overwritten if additional vessels are selected You can save up to 10 cases on the system The oldest case is overwritten if additional cases are started Overwriting takes place when the next FFR recording is initiated after 10 recordings have been saved Note The system saves 10 seconds o...

Страница 50: ...fer to page 41 for detailed instructions Case Summary Assuming that you saved a recordings for at least one vessel for one patient case you may review the case summary Press the Case Summary button Refer to page 70 for detailed instructions on using the Case Summary window to review a case and export case summary data Note If a USB memory device is connected when an FFR recording is saved the FFR ...

Страница 51: ...User s Guide 45 901700 001 01 2019 09 English Shutting Down the ACIST RXi System Power Off Shut down the ACIST RXi System by using the switch on the right side of the unit Power ON OFF Switch ON power OFF power Shutting Down the ACIST RXi System ...

Страница 52: ...46 ACIST RXi System User s Guide 901700 001 01 2019 09 English Basic Operating Procedures This page intentionally left blank ...

Страница 53: ... tasks View the software version of the system View the current date and time View or adjust system settings These settings include language for the user interface date time facility name lab ID monitor output sensitivity audio volume touchscreen calibration View or adjust waveform settings These settings include mean pressure calculation sweep speed graph scale maximum Pa scaling restore default ...

Страница 54: ...CIST RXi System User s Guide 901700 001 01 2019 09 English System Information and Settings When you press the ACIST logo on the main screen the ACIST menu is displayed Press the ACIST logo to view the ACIST menu The ACIST menu ...

Страница 55: ...mation System Software Version Date and Time To view the system software version and the system date and time press ACIST System Information The System Information pop up window appears as shown below Note that the Software Version displayed on your system will not match the one shown here System Information ...

Страница 56: ...19 09 English System Information and Settings The ACIST Main Menu provides the System Settings submenu Note These settings cannot be adjusted while the system is recording the FFR All saved system settings are automatically restored at system startup System Settings ...

Страница 57: ...ange the language of the software user interface Note The language selection also sets the decimal delimiter to a dot or a comma whichever is correct for the selected language English EU uses the comma delimiter instead of the dot To change the language use the arrows to scroll to the desired language and press the desired language the radio button next to the language you selected activates then ...

Страница 58: ...t the Date Setting The current date is displayed in the Date Time field of the System Information pop up window To adjust the date press ACIST System Settings Date Use the plus and minus buttons to adjust the Month Day and or Year settings then press OK to accept the new date or Cancel to exit without making changes ...

Страница 59: ...in the Date Time field of the System Information pop up window The time is based on a 24 hour clock 00 00 to 23 59 with 00 00 representing 12 a m Note The RXi System time is not adjusted automatically for daylight savings time Use the plus and minus buttons to adjust the Hour and Minute settings then press OK to save the new time or Cancel to exit without making changes ...

Страница 60: ...with each button the Delete button to delete a character the Shift button to enter a capital letter the Space button to enter a blank space the Caps Lock button to enter characters in all caps the Mode button to select alternate keyboard characters When you have finished entering the Facility name press Enter to close the Facility Name pop up keyboard To close without making any changes press the ...

Страница 61: ...e mode the ACIST RXi System is designated as a mobile device In this mode the system prompts you to zero the aortic pressure on the ACIST RXi System for every patient case In Stationary mode the ACIST RXi System is designated as a stationary device and is intended to remain installed in one room In this mode zeroing the aortic signal input on the ACIST RXi System is only required at installation W...

Страница 62: ...s as shown below Use the keyboard to enter the Lab ID Use the buttons listed below to perform the task associated with each button the Delete button to delete a character the Shift button to enter a capital letter the Space button to enter a blank space the Caps Lock button to enter characters in all caps the Mode button to select alternate keyboard characters When you have finished entering the L...

Страница 63: ...buttons as needed to scroll through the study dates as well as the list of studies Monitor Output Sensitivity Setting Contact your ACIST Service Representative for assistance in adjusting the Monitor Output Sensitivity setting This setting is adjusted at installation to match the system output voltage to the hospital s hemodynamic monitor and should not be changed It should be modified only if nec...

Страница 64: ...ise accompanies pressing any of the touchscreen buttons Press the corresponding radio button to set button tones to On or to Off Touchscreen Calibration To recalibrate the console panel touchscreen press ACIST System Settings Touchscreen Calibration and perform the following steps 1 Touch the calibration target on the screen to start the four point calibration 2 Touch the target as it moves around...

Страница 65: ...ngs ACIST RXi System User s Guide 59 901700 001 01 2019 09 English Adjust the Waveform Settings The Waveform Settings option on the ACIST Main Menu provides a submenu of waveform configuration options Adjust the Waveform Settings ...

Страница 66: ...ing is 3 heartbeats In the case of intracoronary administration of the vasodilator the default setting of 3 heartbeats is recommended Note This setting can affect the resting Pd Pa or FFR value For FFR this is dependent on the amount of time maximum hyperemia is maintained in an individual patient To change the number of heartbeats setting press the radio button next to the preferred number of hea...

Страница 67: ...T Waveform Settings Sweep Speed to view the Sweep Speed pop up window enabling you to adjust the sweep speed in the waveform display area of the screen Sweep speed options include 5 10 15 or 20 mm s The default is 10 mm s To change the sweep speed setting press the radio button next to the preferred sweep speed then press OK The system displays the pressure waveform based on the adjusted setting P...

Страница 68: ...button next to the preferred setting then press OK The system displays the pressure waveform based on the adjusted setting Press Cancel to exit without making changes Pa Scaling Press ACIST Waveform Settings Pa Scaling to view the Pa Scaling pop up window This window enables you to perform Pa Scaling if required If the Pa value displayed is equal to or within 1 mm Hg of the Pa value on the hemodyn...

Страница 69: ...ore the System Defaults for the Waveform Display Press ACIST Waveform Settings Restore Defaults to view the Restore Defaults pop up window This window enables you to restore all the waveform display parameters mean pressure calculation sweep speed and graph scale maximum as well as venous pressure to the factory default settings ...

Страница 70: ...e Delete button to delete a character the Shift button to enter a capital letter the Space button to enter a blank space the Caps Lock button to enter characters in all caps the Mode button to access an alternate character set When you have finished entering the Patient ID press Enter to close the Patient ID pop up keyboard To close the keyboard without making any changes press the X in the upper ...

Страница 71: ...pressure sensor on the Navvus MicroCatheter is connected to the ACIST RXi System and the microcatheter is extracted from the patient s body Press ACIST Zero Pressure Sensor and the following confirmation message appears Note The Navvus MicroCatheter pressure sensor is automatically zeroed when the purple handle is inserted into the ACIST RXi System Zero the Pressure Sensor ...

Страница 72: ...me To change the audio volume setting and decide if a sound should accompany button presses on the touchscreen System Settings Touchscreen Calibration To calibrate the touchscreen System Settings Install Software To install software upgrades from a USB memory device that has valid software Waveform Settings Mean Pressure Calculation To change the current heartbeat count used for the mean pressure ...

Страница 73: ...essel Button At the beginning of a new patient case the Vessel ID field is blank as shown below In this example the Vessel ID field is blank Press the New Vessel button to define a new Vessel ID The system displays Vessel1 as the default Vessel ID as shown in the example below In this example the Vessel ID field displays Vessel1 Additional Settings ...

Страница 74: ... Vessel ID field The Vessel ID pop up window displays 18 pre defined vessel names It also provides a pop up keyboard to enter custom vessel IDs as shown below Keyboard Icon Press a Vessel ID from the displayed list to select a Vessel ID and close the pop up window Or press the keyboard icon and create a Vessel ID name as described in the next section ...

Страница 75: ...d below to perform the task associated with each button the Delete button to delete a character the Shift button to enter a capital letter the Space button to enter a blank space the Caps Lock button to enter characters in all caps the Mode button to use an alternate character set When you have finished creating the Vessel name press Enter to close the keyboard or press the X in the upper right co...

Страница 76: ...s shown below Use these scroll buttons to review all the saved case summaries Use the left right scroll buttons to review up to 10 FFR recordings for a Vessel ID Use the up down scroll buttons to review the recorded FFR values for up to 10 Vessel IDs Select the OK button to close the Case Summary window Select any FFR value from the Case Summary screen to view the snapshot of the FFR recording Sel...

Страница 77: ... will also display at the top of the screen To add a patient ID to the FFR Review screen press the keyboard icon in the upper right corner of the FFR Review screen The FFR minimum location is indicated by a white vertical line Ten seconds of the recorded waveform if available before and after the FFR minimum location is displayed as shown in the example below Press the arrow keys on either side of...

Страница 78: ...Press the Zero Aortic button on the main screen to zero the aortic signal When you press Zero Aortic a confirmation pop up window instructs you to open the stopcock and press OK to zero the aortic pressure Press OK to zero the aortic pressure or press Cancel to return to the ACIST RXi System s main screen You may be prompted to re equalize ...

Страница 79: ...e a correction for the venous pressure Pv setting High venous pressure which is a setting above 8 mmHg will have a significant impact on FFR or resting Pd Pa values A high Pv value results in lower FFR or resting Pd Pa FFR Pd Pv Pa Pv Note Resting Pd Pa uses the same governing equation as FFR under a non hyperemic state Press OK to use for the current case only or press Save as default to use the ...

Страница 80: ...74 ACIST RXi System User s Guide 901700 001 01 2019 09 English System Information and Settings This page intentionally left blank ...

Страница 81: ...e the Navvus MicroCatheter connection port without the proper cleaning tools Refer to Optional Fiber Optic Cleaning Process on page 78 Use only a soft cloth dampened with water to clean the system Do not use detergents cleaning solutions isopropyl alcohol or steam to clean the system Never spray or pour any liquid directly onto the power supply or the system console Never allow oil or materials co...

Страница 82: ...nating the system CAUTION Never allow oil or materials containing oil to come in contact with any part of the system console Never spray or pour any liquid directly onto the power supply system console or control panel Do not use any sharp objects or apply excessive pressure to any component Discard all cleaning materials in accordance with all local state and federal regulations codes and directi...

Страница 83: ...tive gloves and eye protection when cleaning or decontaminating the system CAUTION Never allow oil or materials containing oil to come in contact with any part of the system console Never spray or pour any liquid directly onto the power supply system console or control panel Do not use any sharp objects or apply excessive pressure to any component Discard all cleaning materials in accordance with ...

Страница 84: ...is shown but any equivalent off the shelf dry cleaning tool for use with fiber optic LC MU and APC connections can be used Perform the following steps to clean the Patient Interface Module PIM 1 Turn off power to the system 2 Insert the PIM Door Opener completely into the PIM assembly 3 Remove the white adapter cap on the Senko Smart Cleaner to expose the cleaning filament 4 Insert the exposed fil...

Страница 85: ...he cleaner to ensure the cleaning filament works properly 6 Remove the fiber optic cleaner from the PIM assembly 7 Clean and disinfect the filament and any portion of the cleaner that potentially came in contact with the PIM assembly 8 Replace the white adapter cap on the cleaner 9 Remove the PIM door opener from the PIM assembly ...

Страница 86: ... containing oil to come in contact with any part of the system console Never spray or pour any liquid directly onto the power supply or system console or control panel Do not use any sharp objects or apply excessive pressure to any component Discard all cleaning materials in accordance with all local state and federal regulations codes and directives Perform these inspection and maintenance items ...

Страница 87: ...ssage windows display messages to inform or warn you to follow the instructions in the window Use information in the table on page 88 to help determine the probable cause and the corrective action for the messages displayed in the pop up message windows General Troubleshooting Procedures Before contacting ACIST Medical Systems about a problem perform the following steps 1 Follow instructions in th...

Страница 88: ...RXi System User s Guide 901700 001 01 2019 09 English Troubleshooting and Support 8 Resume operation If you are unable to resolve a problem or if you have any problems or concerns contact an ACIST Medical Systems service representative ...

Страница 89: ... Indicator LED LED State Condition Off The Navvus MicroCatheter is not connected to the RXi System On Blue The Navvus MicroCatheter is connected to the RXi System and the system is checking the functionality of the sensor On Green The Navvus MicroCatheter is connected to the RXi System and is functioning properly On Red The Navvus MicroCatheter is connected to the RXi System and software detects a...

Страница 90: ...ly when using very small diameter catheters filled with contrast Perform a saline flush before recording physiological waveforms with the transducer system When using an ACIST or a third party hemodynamic transducer clear all tubing of air to avoid producing an inaccurate reading Pressure Waveform Accuracy To ensure accurate waveforms zero the hemodynamic transducer with both the transducer and th...

Страница 91: ...defective microcatheter with a broken fiber optic cable remains connected to the system the system resumes alarming Following a power interruption no matter how brief if the ACIST RXi System has been set up as a mobile device aortic pressure must be zeroed Refer to page 72 for instructions on performing this procedure If it has been set up as a stationary device it does not need to be zeroed For a...

Страница 92: ...nd Support Status messages appear at the top of the main screen The Status Message area of the window provides user instructions and system status information The following table provides a summary of the status messages the purpose of each message and the recommended user response Interpreting Status Messages ...

Страница 93: ...case Prior to each case open the stopcock at the midaxillary position zero the hemodynamic system and press the zero aortic button Connect Pressure Sensor Instructs you to connect the Navvus MicroCatheter to the RXi System Insert the handle assembly of the catheter in the Navvus MicroCatheter connection port of the RXi System Console Equalizing Informs that the RXi System is equalizing the aortic ...

Страница 94: ...ooting and Support The following table describes messages displayed in response to system conditions All messages in the ACIST RXi System are color coded as follows according to their severity Red warning or error Yellow information user input required Blue information only Color coded Pop up Messages and Problem Conditions ...

Страница 95: ...e catheter with a new one Immediately remove and replace the Navvus MicroCatheter Yellow Software installation files have been detected Press OK to start the software installation Press OK to confirm and close the message The system starts the software installation process Yellow Are you sure you want to discard this record Press OK to discard this Record Press OK to confirm and close the message ...

Страница 96: ...roblem with the pressure sensor Press OK to confirm and close the message This is a notification that the FFR data has been interrupted because there is a problem with the pressure sensor located within the Navvus MicroCatheter Inspect the microcatheter unplug and plug in if needed or replace the microcatheter Note If you unplug the microcatheter it ends the case Blue The FFR recording has been di...

Страница 97: ...w This window also allows you to turn the button tone either On or Off Case Summary Button The Case Summary button is used to view currently saved FFR data Any FFR value can be selected to view the snapshot of the FFR recording Also included in the Case Summary are the date and start time lab ID and facility name facility name is only displayed in exports If a patient ID was entered it is only sto...

Страница 98: ...ximum Pop up window allows adjustment of the maximum pressure value displayed on the waveform graph The allowable values are 100 mmHg 150 mmHg 200 mmHg and 250 mmHg with default being 200 mmHg To provide the most legible curve the smallest value suitable for the patient should be used Install Software Allows installation of software upgrades via a USB memory device that has valid software installe...

Страница 99: ... to start the FFR recording Stationary Mode In the Stationary mode the RXi System is set up as a stationary device which means it will remain installed in one room The aortic signal input only needs to be zeroed at installation or if it is connected to a different hemodynamic system Stop Button When recording is started the Record button changes to a Stop button which stops recording at any time w...

Страница 100: ...ressure at patient midaxillary height Pressing this button zeroes the Aortic Pressure on the RXi System Zero Pressure Sensor Option Select this option on the ACIST Menu when the Navvus MicroCatheter pressure sensor is connected to the RXi System This option should only be used when the microcatheter pressure sensor is reading atmospheric pressure Your are prompted to remove the microcatheter from ...

Страница 101: ... Frequency 47 to 63 Hz includes 5 tolerance RXi System voltage 12 VDC for the specified external switching power supply RXi System DC amps 0 9 A DC maximum Note The power supply must be positioned to provide easy access to either or both ends of the line power cable for disconnection from mains power Electrical Leakage Current Amount Patient leakage current Less than 10 µA Enclosure leakage curren...

Страница 102: ...on proof type CF applied part Degree of protection against ingress of water IPX0 Methods of sterilization or disinfecting None Mode of operation Continuous WARNING This equipment is not suitable for use in the presence of flammable anesthetic agents For UL labeled product C UL Classified Mark Medical Electrical equipment Classified by Underwriters Laboratories Inc with respect to electric shock fi...

Страница 103: ...106 kPa 11 to 15 psi 77 to 106 kPa Operating Environment Requirements Requirement Range System Range Catheter Ambient Temperature 64 to 86 F 18 to 30 C 64 to 86 F 18 to 30 C Relative Humidity 10 to 95 Non condensing 10 to 95 Non condensing Atmospheric Pressure 11 to 15 psi 77 to 106 kPa 11 to 15 psi 77 to 106 kPa Weight Component Weight System console with power supply and cables 20 lb 9 1 kg Dime...

Страница 104: ...re thoughout 580 to 800 mmHg absolute atmospheric pressure Pressure accuracy 3 of reading or 3 mmHg of reading over pressure range whichever is greater including the combined effects of sensitivity repeatability non linearity and hysteresis Pressure drift 7 mmHg over 1 hour Frequency response Response at 10 Hz within 3 dBA of the response at 1 Hz Input sensitivity Compatible with 20 mmHg V or 100 ...

Страница 105: ...s with an optimal cutpoint ranging from 0 875 to 0 96 and resulted in cutpoints from 0 91 to 0 93 in 12 of the 14 studies in the meta analysis The ACIST FFR Pd Pa Post hoc Sub Group Analysis2 identified an optimal cutpoint of 0 91 The cutpoint was derived from a post hoc receiver operating characteristic ROC curve analysis using an FFR cutoff value of 0 80 measured with the ACIST Navvus MicroCathe...

Страница 106: ...e Electromagnetic Environment Guidance RF emissions EN 55011 2009 A1 2010 CISPR 11 2009 A1 2010 Group 1 Class B The RXi System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Harmonic emissions IEC 61000 3 2 2006 A1 2009 A2 2009 Class B Voltage fluctuations flicker emissions IEC 61000 ...

Страница 107: ...EN 60601 1 2 2015 4th Edition 1 KV differential mode 2 KV common mode Criterion A Criterion A Mains power quality should be that of a typical commercial or hospital environment Power frequency 50 60 Hz magnetic field EN IEC 61000 4 8 per IEC 60601 1 2 2014 and EN 60601 1 2 2015 4th Edition 3 A m Criterion A Power frequency magnetic fields should be at levels characteristic of a typical location in...

Страница 108: ... m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is a...

Страница 109: ...re controlled The customer or user of the system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the RXi System as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of tr...

Страница 110: ...d during EMC EMI testing to validate broken fiber detected during testing Electrical Fast Transient Burst 4th Edition Criterion B Surge 4th Edition Criterion A Voltage dips short interruptions and voltage variations on power supply input lines 4th Edition Criterion A 4th Edition 250 300 cycle dip Criterion C 4th Edition additional Phase angles Criterion A Power Frequency 50 60 Hz Magnetic Field 4t...

Страница 111: ...ys of the apparent malfunction This warranty is void if the product has been a repaired by someone other than ACIST or its authorized agent b modified or altered in any way as to in the judgment of ACIST affect its function c misused or d damaged by negligence accident or intent This warranty does not cover routine wear and tear on the product THE FOREGOING WARRANTIES ARE EXCLUSIVE AND IN LIEU OF ...

Страница 112: ...OR THE FAILURE OF THE PRODUCT S TO PERFORM AS SPECIFIED EVEN IF ACIST SHALL HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES IT IS REQUIRED THAT THE ACIST PRODUCT BE OPERATED BY OR UNDER THE IMMEDIATE DIRECT SUPERVISION OF A LICENSED DOCTOR OR OTHER LICENSED HEALTH CARE PROFESSIONAL QUALIFIED TO USE THE PRODUCT AND PERFORM THE PROCEDURE ACIST DISCLAIMS LIABILITY FOR ALL INJURIES DEATHS OR PROP...

Страница 113: ...is a signal splitter that allows the ACIST RXi system to receive Ao aortic input from transducers that would otherwise be connected to the hemodynamic system Note With the Ao Interface Box attached the RXi System is in compliance with Class A RF emissions Indications for Use Intended Use The RXi Ao Interface Box is indicated for use with the RXi System in order to receive aortic pressure input fro...

Страница 114: ...uide 901700 001 01 2019 09 English Appendix Ao Interface Box Hemodynamic systems where the output channels are dedicated to other cath lab equipment The Ao interface box is intended to connect to the transducer RXi and the hemodynamic system ...

Страница 115: ...t Position the mounting holes on the Ao Box assembly bracket over the holes in the RXi mount flange and reattach the screws Note If using the remote mounting option refer to the section Ao Interface Box Installed with Remote Mounting Bracket Cable Connections to Ao Interface Box The following illustration shows the cable connections to the Ao Interface Box when installed on the console 1 2 3 1 2 3...

Страница 116: ...d of the cable connector with the gray arrow on the male connector on the box Push the connector in until it clicks to make the attachment secure Pull gently on the cable to ensure it is fastened securely 5 Connect the other end of the cable to the cath lab invasive blood pressure IBP transducer that would normally connect to the hemo system After making the connection tug slightly on the connecto...

Страница 117: ...cket A from the Ao Interface Box that is connecting the Ao Interface Box to the RXi console by removing the two screws as illustrated below Bracket A Reuse the same screws to attach the remote mounting bracket Bracket B to the Ao Interface box Slots for hook and loop fastener Straps Bracket B This assembly can now be used with the supplied hook and loop fastener straps to attach the Interface Box ...

Страница 118: ...o System To Transducer 1 Connect the male end of the long cable with the BNC to BNC connectors 4 to connector 1 on the Ao Interface Box which has been installed remotely 2 Connect the female end of this cable to the BNC connector 1 on the short cable PN 301764 Connect the other end of the short cable to the RXi Ao input connector as shown in the above illustration Connect remaining cables as descr...

Страница 119: ...If a Medex Back Plate is present press and hold down the 100 mmHg button Connect a calibrated variable pressure gauge and manually supply a value of 100 mmHg to an attached internal blood pressure transducer Attach a syringe to a stopcock connected to the pressure transducer and depress plunger to apply a non zero pressure value Close the stopcock to hold pressure during calibration 6 Confirm that...

Страница 120: ...sh Appendix Ao Interface Box 9 If the RXi system is not reading 100 mmHg while 100 mmHg is supplied to the transducer use the Pa Scaling function on the RXi software to adjust the signal gain up or down to match 100 mmHg Refer to Perform Pa Scaling in Section 4 Installation ...

Страница 121: ... Close the stopcock 4 Continue the case as described in Section 5 Basic Operating Procedures CAUTION Whenever the hemo system is zeroed ensure the stopcock is open and actively zero RXi using the Zero Aortic button Cleaning and Maintenance Routine inspection is required to keep the Ao interface box in optimal working condition Inspect cables for cuts nicks and openings in the cable insulation Chec...

Страница 122: ...116 ACIST RXi System User s Guide 901700 001 01 2019 09 English Appendix Ao Interface Box This page intentionally left blank ...

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Страница 124: ...901700 001 01 2019 09 English ACIST Medical Systems Inc 7905 Fuller Road Eden Prairie MN 55344 USA ...

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