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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ACIST RXi System User’s Guide | 5901700-001,01 2019-09 English
Read this First!
2
Before using the ACIST RXi® System, please read and fully understand this
entire section. Failure to do so may result in serious injury to the patient or the
user, or damage to the ACIST RXi System or other equipment. If you have any
questions aer reading this section, please contact ACIST Medical Systems,
Inc. Technical Services.
e following warnings refer to hazards that can cause serious injury or death.
Read this section carefully.
• To avoid the risk of electric shock, this equipment must only be
connected to a supply mains power outlet with protective earth.
• No modication of this equipment is allowed.
• In order to avoid the potential for electric shock to the patient, do not
simultaneously touch the patient and either the system console screen,
USB, Ethernet or hemodynamic connectors located behind the sterile
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.
• e Navvus MicroCatheter is supplied sterile in a protective carton
containing a sterile barrier tray. Sterility is indicated by a chemical
process ‘dot’ label, which during successful sterilization turns green.
Verify package integrity before use. If the sterile barrier package is
damaged or the seal is not intact, or if the dot is not green, DO NOT
use the product. Contact an ACIST representative to return damaged
product. Do not use this product beyond the ‘Use by’ date indicated, as
product integrity and sterility cannot be guaranteed.
• Any serious incidents related to the product or its use must be reported
to ACIST Medical Systems, Inc., as well as the competent authority
of the Member State or country in which the user and/or patient is
established.
Read this First!
Warnings
Warnings, Cautions, and Symbol
Denitions

Warnings
6| ACIST RXi System User’s Guide 901700-001,01 2019-09 English
Warnings, Cautions, and Symbol Denitions
• Improper technique may damage a the Navvus MicroCatheter.
Exercise care in handling the microcatheter during a procedure to
reduce the possibility of accidental breakage or kinking.
• Do not disturb pressure sensing system elements during equalization
or FFR recording.
• If a broken ber optic is detected within the Navvus MicroCatheter,
a visual and auditory technical alarm condition is triggered. e
defective microcatheter, along with the guide catheter, must be
immediately removed 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
aer you zero the hemodynamic monitoring system or an incorrect
FFR or resting Pd/Pa value may result.
• To prevent electric shock, always turn o power to the system and
disconnect the power cord from the main power source before
performing any cleaning or service procedure.
• Never touch any pins on connectors or cables that have become
disconnected from a system while power is on.
• Never immerse any system component in water or in a cleaning
solution.
• is equipment is not suitable for use in the presence of ammable
anesthetic agents.
• e RXi system should not be used in rooms containing magnetic
resonance imaging (MRI) equipment.

Warnings, Cautions, and Symbol Denitions
ACIST RXi System User’s Guide | 7901700-001,01 2019-09 English
Cautions
e following cautions refer to hazards that could result in minor injury or
damage to the system or other equipment. Read this section carefully.
• is system is not intended for use as a blood pressure monitoring
system.
• Use only the supplied medical grade power converter (Model
MENB1030A1249F02) to ensure safe operation of the ACIST RXi
System.
• To prevent equipment damage, accessory equipment connected to the
analog or digital interfaces on the RXi System must be certied to the
respective IEC standard UL/IEC 60601-1 for medical equipment. Any
person who connects equipment to the input or output signal port is
conguring a medical system. erefore, this person is responsible for
ensuring that the system complies with the requirements of the system
standard UL/IEC 60601-1. If in doubt, consult ACIST Medical Systems
Technical Services or your local ACIST representative for assistance.
• 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.
• Connect only to certied 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 qualied medical professionals may use the ACIST RXi System.
User vigilance is required at all times when using the system.
• To avoid inaccurate arterial pressure measurements, the use of guide
catheters larger than 8F or guide catheters with side holes are not
recommended. Avoid blocking blood ow to the selected artery. Do not
wedge the guide catheter in the selected artery.
• Carefully place the Navvus MicroCatheter on the guidewire to avoid
damage to the tip. Avoid contact between the guidewire and the small
pressure sensor that is just proximal to the microcatheter tip.
• Tighten the Tuohy Borst adapter on the guide catheter aer placing the
Navvus MicroCatheter distal sha inside the guide catheter, or false
low aortic pressure readings may result.
• Open the hemostasis valve fully to avoid damage to the Navvus
MicroCatheter tip.
• Do not perform high pressure (greater than 600 psi) uid injections
while the Navvus MicroCatheter tip is inside a guide catheter.
• Observe all Navvus MicroCatheter movement in the vessel. When
the microcatheter is in the body, it should be manipulated only under
uoroscopy. Do not attempt to move the microcatheter without
observing the resultant tip response.
Cautions

Cautions
8| ACIST RXi System User’s Guide 901700-001,01 2019-09 English
Warnings, Cautions, and Symbol Denitions
• Always advance or withdraw a Navvus MicroCatheter slowly and
carefully.
• Verication of aortic and distal pressures is very important for the
upcoming pressure recordings. If the baselines are not equal at
this point, a systematic error will be created throughout the FFR
calculations.
• Always wear protective gloves and eye protection when cleaning or
decontaminating the system.
• 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 directives.
• Inaccurate measurements from the hemodynamic pressure transducer
may result if the transducer is not prepared and connected correctly.
• With 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
hemodynamic signal dri is suspected, re-zero the transducer.
• Prior to recording physiological blood pressures with the
hemodynamic pressure transducer, re-zero the transducer at the
patient midaxillary position to establish a clear baseline. (Changes in
bed height, atmospheric pressure, catheter hub position, uid density,
and so on, may aect the baseline pressure.)
• e blood pressure waveform may be dampened signicantly when
using very small diameter catheters lled with contrast. Perform
a saline ush 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.
• Whenever the hemo system is “zeroed”, ensure the stopcock is open
and actively zero RXi using the Zero Pa button.

Warnings, Cautions, and Symbol Denitions
ACIST RXi System User’s Guide | 9901700-001,01 2019-09 English
Symbol Denitions
Symbol Denition
Caution
Type CF applied part
Debrillation-proof type CF applied part
Manufacturer, Date of manufacture
Date of manufacture
Serial number
Catalog number
Collect separately
With respect to electrical shock, re, mechanical, and
other specied 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
Specications.
Direct Current (5031)
Class II equipment
Keep dry
Consult instructions for use or consult electronic
instructions for use
Symbol
Denitions

Symbol Denitions
10 | ACIST RXi System User’s Guide 901700-001,01 2019-09 English
Warnings, Cautions, and Symbol Denitions
Symbol Denition
On power
OFF power
Temperature limitation
Humidity limitation
Pressure limitation
Refer to instruction manual/booklet
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
Single sterile barrier system inside protective packaging

ACIST RXi System User’s Guide | 11901700-001,01 2019-09 English
System Hardware
3System Overview
e ACIST RXi® System includes three main hardware components:
• system console
displays blood pressure and computes 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 Hardware

System Hardware
12 | ACIST RXi System User’s Guide 901700-001,01 2019-09 English
System Overview
Pivoting Mount System that attaches to the ACIST CVi Injector
e system hardware also includes the following:
• power and communication cables
• hemodynamic monitor cables

System Overview
ACIST RXi System User’s Guide | 13901700-001,01 2019-09 English
System Hardware
System Console
e system console provides the main user interface for the ACIST RXi
System, and includes the following features:
• color touchscreen display, which provides pop-up message notications
and button touch feedback
• Navvus® MicroCatheter port
• speaker, which provides audible alerts
• USB port used for installing soware updates and exporting
screenshots of FFR results
• hemodynamic cable ports
• power cable
System Power Supply
e 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 Touchscreen
Display
Navvus MicroCatheter
Port Navvus MicroCatheter
Status Indicator LED
System Status
Indicator LED
Power
Cable
Connector
USB Port
Aortic Pressure
(Pa) Cable Port
Distal Pressure
(Pd) Cable Port
(service use only)
NOTE: This panel is
on the underside of
the console.

Touchscreen User Interface
14 | ACIST RXi System User’s Guide 901700-001,01 2019-09 English
System Overview
Purpose of the Touchscreen
e console touchscreen is the main user interface for the ACIST RXi System
and provides the following functionality:
• guides the user in system operation
• zeros the 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
• identies 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
e following example of the console touchscreen shows the user interface
upon initial startup.
Touchscreen User
Interface