ACIST CVi User manual

User’s Guide
ACIST | CVi®
Contrast Delivery System
Bracco Group
901418-003,01 2019-08
English (USA)

2| English (USA) 2019-08 901418-003,01 ACIST | CVi® System User's Guide
Proprietary Information Notice
is 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.
e 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. ISOVUE is a registered trademark of Bracco
Diagnostics,Inc. DisCide ULTRA is a registered trademark of Palermo
Healthcare. LogiCal and Smiths are registered trademarks of Smiths
GroupPLC. Other trademarks are the property of their respective owners.
Contact Information
Website acist.com
USA ACIST Medical Systems, Inc.
7905 Fuller Road
Eden Prairie, MN 55344 USA
Technical Support
Tel: [phone] or 1 952.941.3507
Fax: [phone]
customer.sup[email protected]

ACIST | CVi® System User's Guide 901418-003,01 2019-08 English (USA) | 3
Contents
1 Introduction
Intended Use ..................................5
Contraindications ..............................5
Requirements for Use ..........................5
Aseptic Technique..............................6
About This User’s Guide ........................6
Manual Conventions ...........................7
2 Warnings, Cautions, and Symbol Denitions
Warnings ......................................9
Aseptic Technique ..........................9
Air Embolism ...............................9
Air in the Monitoring Line ...................9
Air Column Detect Mechanism ..............9
Disconnect Before Flushing Air .............10
Use of Patient Kits..........................10
Cables .....................................10
Catheters ..................................10
Cleaning...................................10
Closed Stopcock ...........................11
DEHP (Phthalate)...........................11
Electrical Isolation..........................11
Emergency Shutdown .....................11
Flammable Gases ..........................11
High Flow Rate Injections ..................11
Injection System Setting ...................11
Mounting System ..........................11
Residual Contrast ..........................11
Shock Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
System Messages ..........................12
Safe Use of Equipment .....................12
Cautions ......................................13
Accessories ................................13
Bed Rail Mount ............................13
Cleaning...................................13
Control Panel Touch Screen ................13
Electromagnetic/Electrostatic Guidance ....13
Excessive Injections . . . . . . . . . . . . . . . . . . . . . . . .14
Eye Protection .............................14
Injection System Temperature ..............14
Leakage Current ...........................14
Line Power.................................14
Lock Button................................14
Locking Wheels . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Mixing Hardware Components .............14
Mounted System...........................14
Pressure Transducer........................14
Preventive Maintenance....................15
Removing the Contrast Spike...............15
Rx Only ....................................15
Saline Pump ...............................15
Training ...................................15
X-Ray Cable................................15
Symbol Denitions ............................16
3 System Description
Introduction ..................................19
System Hardware .............................20
Power Supply ..............................21
Injector Head ..............................22
Mounting..................................22
Audible Indicators.............................24
Touchscreen Functions and
Sample Injection Images ......................24
Flow.......................................24
Volume ....................................24
Pressure ...................................24
Rise Time ..................................25
Select Injection ............................25
Patient Kits....................................28
Select Mode ...............................28
End Case...................................28
System Messages Area .....................28
BT2000 Manifold Kit........................29
AT P54 and AT P65 AngioTouch Kits.........29
A2000 Syringe Kit ..........................30
4 Setup
Setup Overview ...............................32
Power On .....................................32
Prepare the Contrast Container ................33
Load the Syringe Assembly ....................34
Load Contrast .................................34
Load Saline Tubing Assembly ..................37
Purge the Tubing..............................39
AngioTouch
Hand Controller Setup.........................40
Connect the Patient Catheter ..................41
Zero the Pressure Transducer ..................41
5 Perform an Injection
Adjust Parameters Based on
Physician Preference ..........................43
Arm the Injector...............................44
Inject Contrast ................................44
Large Injections............................44
Disarm the Injector.........................44
Automatic and Manual Rells...............44
Perform Contrast Purge .......................45
Perform Saline Flush using
0.9% Normal Saline............................45
X-Ray Sync (Optional) ......................45
Flush Saline Using the Hand Controller .....45
Standby ......................................46

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6 End a Case
End the Case ..................................47
End Case...................................47
If Beginning a New Case with
the Same Syringe .......................47
If Using a New Syringe .....................48
If Final Case................................49
Emergency Case ...........................49
7 Supplementary Procedures
General Cleaning Instructions .................51
Cleaning / Disinfection Procedure ..........52
Monthly Inspection ...........................54
Annual Preventive Maintenance ...............54
Storage of Cart-Mounted Systems .............54
Transfer the Injector Head
to/from a Pedestal Cart ........................55
Cabling .......................................56
Connect the Injector Head Cable ...........56
Connect the Control Panel Cable ...........56
Connect the X-Ray Interface Cable on
Standard Systems (Optional) ............57
Connect the X-Ray Interface Cable on
Siemens-Ready Systems (Optional) ......58
Plug In the Power Supply...................59
Mount the Power Supply on a Cart (Optional) ..60
Recalibrate Control Panel Screen...............61
Change the Display Language and
Pressure Units.................................61
Display Language..........................61
Calculate Parameters from Patient Weight......62
Resume an Interrupted Case...................62
Pressure Units..............................62
Change Color Scheme.........................63
System Info ...................................63
Keep Vessel Open (KVO) Injection (Optional) ...63
KVO Injection ..............................63
KVO Rate ..................................63
8 Troubleshooting
Frequently Asked Questions ...................65
Troubleshooting the CVi System ...............67
Air Column Detected.......................67
Contrast Empty/No Contrast ...............67
Hand Controller Calibration Failed ..........68
Pressure Limit Exceeded....................68
Standby!...................................68
Manifold Valve Open .......................68
Manifold valve failed to close ntimes
using current syringe.
Use new syringe? .......................69
Manifold Valve Open Conditions Requiring
Syringe Replacement ...................69
Syringe Valve Closed .......................69
Syringe Valve Open ........................70
Injection Does Not Start....................70
Power Failure ..............................70
Troubleshooting Hemodynamic Issues.........71
Zero Fluctuations ..........................71
Cannot Obtain Zero or Lose Zero Before
Procedure ..............................72
Waveform Dampened......................72
System Messages .............................73
9 Specications
Load Rate .....................................81
Saline Rate ....................................81
Contrast
Injection Parameters ..........................81
Cardiac procedure mode ...................81
Peripheral procedure mode ................81
Pedestal Cart Dimensions .....................82
Accuracy ..................................82
Weight........................................83
Environmental Limits..........................83
Transportation .............................83
Power Supply .................................84
Patient Kits....................................84
Standard ..................................84
Power cord ................................84
Electrical Leakage..........................84
Hemodynamic Transducer.....................85
Supported Imaging Systems...................85
UL Approval ..................................86
10 EMC Tables
EMC Requirements ............................87
11 Limited Warranty

1 Introduction
ACIST | CVi® System User's Guide 901418-003,01 2019-08 English (USA) | 5
e ACIST|CVi® Contrast Delivery System is indicated for controlled
administration of radiopaque contrast media and saline to human subjects
while undergoing angiographic procedures.
e ACIST|CVi® Contrast Delivery System is specically indicated for use in
angiographic procedures for the delivery of ISOVUE® (iopamidol injection)
contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum
of ten (10)hours. e Syringe Kit must be discarded aer six (6) patient
procedures. e Manifold Kit and AngioTouch® Hand Controller Kit must be
discarded aer each patient procedure.
e ACIST|CVi® Contrast Delivery System is to be used only by and under
quasi-continuous supervision of trained health care professionals in an
appropriate licensed health care facility, in a room designated for radiological
procedures that involve intravascular administration of a contrast agent.
e ACIST|CVi® Contrast Delivery System (CVi 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.
For safe use and optimal operation of the CVi system, observe the following
guidelines:
• Caution: Federal (USA) law restricts this device to sale by or on the order
of a physician.
• 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 and 0.9% normal saline 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.
• 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
Intended Use
Contraindications
Requirements for
Use
Introduction

Aseptic Technique
6| English (USA) 2019-08 901418-003,01 ACIST | CVi® System User's Guide
1 Introduction
monitored at all times, and specic operational and mechanical integrity
must be maintained to ensure patient safety.
• Support personnel must ensure that:
ӽ All system connections are in place, secure, and functional.
ӽ Proper grounding and isolation standards are maintained.
ӽ Operational and calibration checks are made prior to each use of the
system.
ӽ Proper support equipment (for example, a debrillation unit) is on site
for immediate response to patient distress.
Employ proper aseptic technique in the handling and use of all patient kits.
Sterile openings must be handled with care to ensure contact with only sterile
connections or a disinfecting cap. e use of gloves is preferred but not
required.
is User’s Guide provides instructions for setting up and using the CVi
system. It includes the following sections:
Section Purpose
1Introduction 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.
4Setup 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
8Troubleshooting 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.
11 Limited Warranty Describes the limited warranty for the
CVi system.
Aseptic
Technique
About This User’s
Guide

ACIST | CVi® System User's Guide 901418-003,01 2019-08 English (USA) | 7
Manual Conventions1 Introduction
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 can cause serious injury or
death.
Manual
Conventions

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1 Introduction
8| English (USA) 2019-08 901418-003,01 ACIST | CVi® System User's Guide

2 Warnings, Cautions, and Symbol Denitions
ACIST | CVi® System User's Guide 901418-003,01 2019-08 English (USA) | 9
Read this entire user guide prior to using the CVi system and patient kits to
ensure proper understanding and use. Operate the device only in accordance
with this user guide to ensure safe and eective use.
Upon arrival, inspect all packaging and the delivered items for signs of damage
that may have occurred during transportation. If any item appears damaged,
contact an ACIST service representative.
e following warnings refer to hazards that can cause serious injury or death.
Please read and understand all the following warnings before proceeding with
installation, setup, and operation of the CVi system.
Aseptic Technique
Contamination of patient kits or the contrast container septum presents a risk
of serious patient injury due to infection. Aseptic technique must be employed.
If suspected contamination has occurred, replace the aected item.
Air Embolism
An air embolism can cause patient injury or death. Operator vigilance and
care, along with a dened procedure, are essential to avoid injecting air and
causing an air embolism. Before injections, clear all air from the entire patient
kit and the angiographic catheter. Make sure that the exterior of the tubing is
dry before inserting it into the air column detect sensor. If any uid is present
on the tubing's exterior surface, the sensor may be unable to detect air.
Air in the Monitoring Line
Clear the monitoring line of all air to avoid producing an inaccurate blood
pressure reading.
Air Column Detect Mechanism
e CVi system is equipped with an air column detect sensor. e air column
detect sensor cannot detect air in the patient catheter, the stopcock, or the
patient tubing past the sensor. is sensor is designed to aid the user in the
detection of air columns in the injection tubing, but it is not designed to
replace the vigilance and care required of the operator in visually inspecting
for air and clearing air from the entire patient kit and angiographic catheter.
e air column detect mechanism is to be used in conjunction with and to
complement the user's other procedures for preventing air injections.
Warnings
Warnings, Cautions, and
Symbol Denitions

Warnings
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2 Warnings, Cautions, and Symbol Denitions
Disconnect Before Flushing Air
When ushing air, be sure the tubing is disconnected from the patient.
Use of Patient Kits
ACIST-provided patient kits are designed, manufactured, and tested for
connection to catheters used in angiographic procedures. Failure to observe the
following guidelines can result in patient injury or equipment damage:
• Do not add any components to the patient kits or in conjunction with the
catheter.
• No valves or other manifolds may be placed inline between the patient kit
and the catheter.
• Do not use the single use kits on more than one patient.
• Do not allow any patient kit loaded with ISOVUE (iopamidol injection)
contrast media to sit unused for more than 10 hours.
• Do not use a syringe kit for more than six cases.
• Dispose of all single use components, including the saline bag, Manifold Kit,
and AngioTouch Hand Controller Kit aer every case.
• Properly discard patient kits in accordance with all local, state, and federal
regulations, codes, and directives.
Cables
Be sure to plug each cable only into the connector designed for it. To avoid the
risk of electric shock, never touch the pins on the connector or cable. Do not
use the CVi system if any worn or damaged cords, cables, or connectors are
detected. For replacement information, contact an ACIST representative.
Catheters
Patient connections must be made using commercially available catheters that
have been approved for angiographic studies. e system pressure limit should
not be set higher than the rated pressure limit of the catheter. For information
on catheter pressure settings and limits, refer to the instructions provided by
the catheter manufacturer.
e CVi system was tested for use with 4Fr–7Fr catheter sizes. When using
catheters 5Fr or smaller with injection ow rates >12ml/s, the system may
reduce the ow rate to prevent Pressure Limit while providing selected volume,
or the system may Pressure Limit and stop the injection. To obtain the desired
imaging outcome in the event of Pressure Limit, the user must either reduce
the selected ow rate or use a larger size catheter to complete the injection.
Cleaning
• To avoid the risk of electric shock, and to prevent damage to the CVi
system, always disconnect it from line power before cleaning.
• Do not use excessive water when cleaning.
• A disinfecting cap must be properly placed onto the multi-use syringe
before cleaning.
• Do not immerse any components in water. Be sure that the CVi system is
completely dry before applying power.