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

vi | ACIST RXi System User’s Guide 901700-001,01 2019-09 English
Interpreting Status Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86
Color-coded Pop-up Messages and Problem Conditions . . . . . . . . . . . . . . . . . .88
9 Glossary 91
10 Technical Specications 95
Electrical Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95
Power Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95
Electrical Leakage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95
UL Classication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96
Other Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97
Operating Environment Requirements . . . . . . . . . . . . . . . . . . . . . . . . .97
Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97
Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97
Cable Lengths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98
Pressure Signal Input. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98
Pressure Signal Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98
Clinical Guidance for Use of Pd/Pa to FFR Measurements . . . . . . . . . . . . . . . . . .99
EMC Tables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions . . . . . . . . . 100
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity . . . . . . . . . 101
Criteria Denitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Recommended Separation Distances Between Portable and Mobile RF Communications
Equipment and the ACIST RXi® System . . . . . . . . . . . . . . . . . . . . . . . . 103
11 Limited Warranty 105
12 Appendix: Ao Interface Box 107
Package Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Device Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Indications for Use/Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Option 1: Installation of Ao Box on the RXi Console . . . . . . . . . . . . . . . . . . 109
Cable Connections to Ao Interface Box . . . . . . . . . . . . . . . . . . . . . . . . 109
Option 2: Ao Interface Box Installed with Remote Mounting Bracket . . . . . . . . . . 111
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Performing a Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Cleaning and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

ACIST RXi System User’s Guide | 1901700-001,01 2019-09 English
Indications for Use/Intended Use
1Introduction
e ACIST RXi® System is indicated for obtaining intravascular pressure
measurements for use in the diagnosis and treatment of coronary and
peripheral artery disease. e ACIST Navvus® MicroCatheter is intended for
use with the ACIST RXi System.
Note
The RXi System is for use only on the order of a physician by medical professionals with
adequate training and experience in the operation of the RXi System and angiographic
procedures and techniques. Additionally, individuals using this device must be alert and
attentive to the operation of the system while it is connected to the patient catheter.
Diligence on the part of the user is an essential requirement of overall device safety.
is product is designed for use in adult patients identied by a physician
as suitable candidates for vascular pressure measurement, taking into
consideration the patient's anatomy and health status.
e ACIST RXi System is designed to provide hemodynamic information
for the diagnosis and treatment of coronary and peripheral artery disease.
e system is intended for use in catheterization and related cardiovascular
specialty laboratories to compute and display fractional ow reserve (FFR) and
resting Pd/Pa.
FFR and resting Pd/Pa supplements the visual data provided by angiography
and provides an assessment of the lesion severity.
Measurement of FFR and resting Pd/Pa requires simultaneously monitoring
the blood pressures proximal and distal to a lesion. e ACIST RXi System
includes a single-use microcatheter with a pressure sensor for acquisition of
the distal pressure. e proximal pressure is acquired via the guide catheter
which is monitored by the ACIST RXi System via an interface to the hospital’s
hemodynamic monitor.
Pd/Pa is the ratio of distal coronary arterial pressure to aortic pressure,
measured at resting conditions. e physician may then use the resting Pd/
Pa value, along with knowledge of patient history, medical expertise and
Indications for
Use/Intended
Use
Intended Patient
Population
Device
Description

About this User’s Guide
2| ACIST RXi System User’s Guide 901700-001,01 2019-09 English
Introduction
clinical judgment to determine if an additional measurement of FFR during
hyperemia or therapeutic intervention is indicated.
is user’s guide provides instructions for setting up and using the ACIST RXi
System. It includes the following sections:
Section Purpose
1Introduction Denes the indications for use and provides a
description of the RXi System. Provides an overview
of the purpose and structure of this user’s guide.
2Warnings, Cautions,
and Symbol
Denitions
Users must read and understand this section
thoroughly before using the RXi System.
3 System Overview Describes the system components and functions.
4Installation
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.
7Maintenance Provides instructions for care and cleaning.
8Troubleshooting and
Support
Provides suggested corrective actions in response
to system messages and conditions.
9Glossary Provides denitions of terms and acronyms.
10 Technical
Specications
Provides technical specications and reference
information.
11 Limited Warranty Provides warranty information.
Appendix: Ao
Interface Box
Provides instructions for installation, operation, and
maintenance of the Ao Interface Box.
About this User’s
Guide

Introduction
ACIST RXi System User’s Guide | 3901700-001,01 2019-09 English
Manual Conventions
is manual uses the following 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

4| ACIST RXi System User’s Guide 901700-001,01 2019-09 English
Introduction
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