ACIST CVi Contrast Delivery System User manual

User’s Guide
ACIST | CVi®
Contrast Delivery System
Bracco Group
901479-002,01 2019-08 English, OUS

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.
Copyright ©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 | CVi, and AngioTouch are registered trademarks of ACIST Medical Systems, Inc. LogiCal and Smiths
are registered trademarks of Smiths Group PLC.
Contact Information
Web site (worldwide) acist.com
USA and Latin America 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]
Europe ACIST Europe B.V.
Argonstraat 3
6422PH Heerlen
The Netherlands
Email: [e-mail]
Technical Support: [phone]
Fax: [phone]
Asia Bracco Imaging MedicalTechnologies (Shanghai) Co., Ltd.
Room 1008, No. 688 West Nanjing Road
Henderson 688
Shanghai, China 200041
Australia Regional Health Care Group Pty Ltd.
PO Box 151
Rosebery NSW 1445
Australia
Tel: [phone]
In other areas of the world, contact your local distributor or representative.

ACIST | CVi Contrast Delivery System User's Guide | 3901479-002,01 2019-08
Contents
Proprietary Information Notice. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1 Introduction 7
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Requirements for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
AboutThis User’s Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Manual Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2 Warnings, Cautions, and Symbol Denitions 11
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Symbol Denitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
3 System Description 21
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
System Hardware. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Injector Head . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Control Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Touchscreen Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
Consumable Patient Kits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
AngioTouch Hand Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
4 Setup 31
Setup Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Load the Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Load Contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Load Saline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
Purge Contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Flush Saline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Connect and Calibrate the AngioTouch® Hand Controller . . . . . . . . . . . . . . . . . .40

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Connect the Patient Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
Repurge Contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
Zero the PressureTransducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
5 Perform an Injection 43
Adjust Parameters Based on Physician Preference . . . . . . . . . . . . . . . . . . . . .43
Arm the Injector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Inject Contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Purge Air from Contrast Components . . . . . . . . . . . . . . . . . . . . . . . . . . .45
Flush Saline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
Standby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
6 End a Case 47
End the Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Remove Single-Use Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Start a New Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Shut Down the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
7 Supplementary Procedures 49
Decontamination. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Daily Cleaning and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Monthly Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
Annual Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
Storage of Cart-Mounted Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
Transfer the Injector Head to/from a Pedestal Cart . . . . . . . . . . . . . . . . . . . . .52
Cabling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53
Mount the Power Supply on a Cart (Optional) . . . . . . . . . . . . . . . . . . . . . . .56
Change the Display Language and Pressure Units . . . . . . . . . . . . . . . . . . . . .57
Resume an Interrupted Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58
Calculate Parameters from PatientWeight. . . . . . . . . . . . . . . . . . . . . . . . .58
Recalibrate Control Panel Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58
Change Color Scheme . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
System Info . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
KeepVessel Open (KVO) Injection (Optional). . . . . . . . . . . . . . . . . . . . . . . .59

ACIST | CVi Contrast Delivery System User's Guide | 5901479-002,01 2019-08
8 Troubleshooting 61
Frequently Asked Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61
Troubleshooting CVi System Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Troubleshooting Hemodynamic Issues . . . . . . . . . . . . . . . . . . . . . . . . . .65
System Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
9 Specications 75
Load Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75
Saline Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75
Viscosity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75
Injection Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75
Pedestal Cart Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
Environmental Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77
Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77
Patient Kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77
HemodynamicTransducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .78
Supported Imaging Systems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .78
UL Approval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
Collect Separately . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
10 EMC Tables 81
11 Limited Warranty 85

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ACIST | CVi Contrast Delivery System User's Guide | 7901479-002,01 2019-08
1Introduction
e ACIST|CVi® Contrast Delivery System is intended to be used for
the controlled infusion of radiopaque contrast media for angiographic
procedures.
e ACIST|CVi Contrast Delivery System is not intended for use as a long-
term infusion pump. e system is not intended to be used to inject any
agents other than contrast media. e system should not be used to inject
substances into nonvascular body cavities.
Any applications of the system, other than those described in this manual, are
inappropriate and should not be attempted.
Do not add any components to the consumable kits or in conjunction with
the catheter. No valves or other manifolds may be placed in-line between
the ACIST-provided consumable kit and the catheter. ACIST-provided
consumable kits are designed, manufactured, and tested for connection to
catheters used in angiographic procedures.
Do not use the system in the presence of ammable gases.
For safe use and optimal operation of the ACIST|CVi Contrast Delivery
System (CVi System), observe the following guidelines:
• Use only accessories and options provided by ACIST Medical Systems,
which are designed specically for the CVi System. is ensures
compatibility with the injector. Do not use an accessory or option
designed for another system on the CVi System.
• e CVi System is designed to aid the physician in the injection of
contrast media during angiography. e system should be used with
adequate radiographic imaging, and where both blood pressure
monitoring equipment and an electrocardiogram are available.
Standard equipment for cardiopulmonary resuscitation and drugs for
the treatment of contrast media-induced drug reactions should be
present.
Intended Use
Contraindications
Requirements for
Use

Introduction
8| ACIST | CVi Contrast Delivery System User's Guide 901479-002,01 2019-08
• It is necessary that the CVi System be operated by, or be under the
immediate and direct supervision of a physician who is specically
trained in angiography and in the operation of this unit. System
operation must be monitored at all times, and specic operational and
mechanical integrity must be maintained to ensure patient safety.
• Support personnel must ensure that:
– All system connections are in place, secure, and functional.
– Proper grounding and isolation standards are maintained.
– Operational and calibration checks are made prior to each use of
the system.
– Proper support equipment (for example, a debrillation unit) is
on site for immediate response to patient distress.
is User’s Guide provides instructions for setting up and using the
ACIST|CVi Contrast Delivery System. It includes the following sections:
Section Purpose
1: Introduction Identies the purpose and structure of
this guide.
2: Warnings, Cautions, and
Symbol Denitions
Users must read and understand this
section thoroughly before using the
CVi System.
3: System Description Provides an overview of the system,
its components, and the touchscreen
interface.
4: Setup Describes the steps necessary to set
up a new case.
5: Perform an Injection Describes the steps for performing a
contrast injection with the CVi System.
6: End a Case Describes the steps for ending a case
and, if desired, starting a new case or
shutting down the system.
7: Supplementary Procedures Provides instructions for cleaning,
maintenance, and infrequently used
options.
8: Troubleshooting Provides answers to frequently-asked
questions, as well as a list of system
messages.
9: Specications Provides technical specications for
the CVi System.
10: EMC Tables Provides EMC tables.
About This User’s
Guide
Requirements for
Use (continued)

Introduction
ACIST | CVi Contrast Delivery System User's Guide | 9901479-002,01 2019-08
Section Purpose
11: Limited Warranty Describes the limited warranty for the
CVi System.
is manual uses the following conventions:
Note
Notes are used to highlight important information from the rest of the text.
Tip
Tips are useful information that may make tasks easier to accomplish.
Important
Information marked as important is vital to the proper operation of the system.
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 cause serious injury or death.
Manual Conventions

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