ACIST RXI User manual

User’s Guide
ACIST RXi® Rapid
Exchange FFR System
Bracco Group
901700-001,01 2019-09 English

ii | ACIST RXi System User’s Guide 901700-001,01 2019-09 English
Proprietary Information Notice
This document contains information proprietary to ACIST Medical Systems, Inc. All rights reserved.
Patents: acist.com/patents
No part of this document may be reproduced, transmitted, processed, or recorded by any means or
form, electronic, mechanical, photographic or otherwise, nor be released to any third party without the
written consent of ACIST Medical Systems, Inc.
© 2019 ACIST Medical Systems, Inc. All rights reserved.
The written and graphic product descriptions in this manual were eective at the time of printing.
ACIST Medical Systems, Inc. reserves the right to change specications and designs without prior
notication.
ACIST, ACIST RXi and NAVVUS are registered trademarks of ACIST Medical Systems, Inc.
Contact Information
Web site (worldwide) acist.com
USA ACIST Medical Systems, Inc.
7905 Fuller Road
Eden Prairie, MN 55344 USA
Technical Support: 1-888-670-7701 or 952-941-3507
Fax: [phone]
Email: [e-mail]
In other areas of the world, contact your local distributor or representative.

ACIST RXi System User’s Guide | iii901700-001,01 2019-09 English
Contents
Proprietary Information Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
1 Introduction 1
Indications for Use/Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Patient Population. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Device Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
About this User’s Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Manual Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2 Warnings, Cautions, and Symbol Denitions 5
Read this First! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Symbol Denitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3 System Overview 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 Pivoting Mount
System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Connect the ACIST RXi® System to the Hospital’s Hemodynamic System . . . . . . . . . .23
Zero the Aortic Pressure on the ACIST RXi® System. . . . . . . . . . . . . . . . . . . .25
Enter the Facility Name and Lab ID (Optional). . . . . . . . . . . . . . . . . . . . . .26

iv | ACIST RXi System User’s Guide 901700-001,01 2019-09 English
Perform Pa Scaling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
5 Basic Operating Procedures 29
Before Using the ACIST RXi® System . . . . . . . . . . . . . . . . . . . . . . . . . . .29
Start the ACIST RXi® System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
Verify that the Aortic Pressure is Zero. . . . . . . . . . . . . . . . . . . . . . . . . . .31
Zero Aortic Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Identify the Patient ID and the Vessel ID for the Case . . . . . . . . . . . . . . . . . . . . 32
Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Vessel ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Unpack and Prepare the Navvus® MicroCatheter . . . . . . . . . . . . . . . . . . . . . . 33
Preparation Needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Deliver the Navvus® MicroCatheter, Equalize Signals, 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 O . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
6 System Information and Settings 47
About the ACIST Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
System Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
System Software Version, Date, and Time . . . . . . . . . . . . . . . . . . . . . . .49
System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
Change the Language Displayed in the System Software. . . . . . . . . . . . . . . . .51
Adjust the Date Setting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52
Adjust the Time Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53
Enter or Modify the Facility Name . . . . . . . . . . . . . . . . . . . . . . . . . . .54
Lab ID, Mobile or Stationary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55
Enter or Modify a Lab ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56

ACIST RXi System User’s Guide | v901700-001,01 2019-09 English
Monitor Output Sensitivity Setting . . . . . . . . . . . . . . . . . . . . . . . . . .57
Adjust the Audio Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58
Touchscreen Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58
Adjust the Waveform Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
Adjust the Number of Heartbeats Used for Mean Pressure Calculation . . . . . . . . . . .60
Adjust the Screen Sweep Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . .61
Adjust the Graph Scale Maximum . . . . . . . . . . . . . . . . . . . . . . . . . . .62
Pa Scaling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62
Restore the System Defaults for the Waveform Display . . . . . . . . . . . . . . . . .63
Create a Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
Zero the Pressure Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Summary of ACIST Menu Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . .66
Additional Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
Dene 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
Decontamination Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Daily Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77
Optional Fiber Optic Cleaning Process . . . . . . . . . . . . . . . . . . . . . . . . .78
Monthly Inspection and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . .80
8 Troubleshooting and Support 81
General Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81
Interpreting LED Indicator Lights. . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
Navvus® MicroCatheter Status Indicator LED . . . . . . . . . . . . . . . . . . . . . .83
ACIST RXi® System Status Indicator LED . . . . . . . . . . . . . . . . . . . . . . . .83
Hemodynamic Pressure Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . .84
Pressure Waveform Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84
Dampened Pressure Tracing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84
Power Interruption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85