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

4| ACIST | CVi Contrast Delivery System User's Guide 901479-002,01 2019-08
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

10 | ACIST | CVi Contrast Delivery System User's Guide 901479-002,01 2019-08
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ACIST | CVi Contrast Delivery System User's Guide | 11901479-002,01 2019-08
2
e following warnings refer to hazards that can cause serious injury or death.
Please read and understand all the following warnings and cautions before
proceeding with installation, setup, and operation of the CVi System.
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 injecting, 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
When using a blood pressure monitor, be sure to clear the monitoring line of
all air to avoid producing an inaccurate blood pressure reading.
Air Column Detect Sensor
e ACIST 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 high-pressure tubing past the sensor. is sensor is designed to aid the
user in the detection of air columns in the injection line, 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.
Disconnect Before Flushing Air
When ushing air, be sure the tubing is disconnected from the patient.
Warnings
Warnings, Cautions, and Symbol
Denitions

Warnings, Cautions, and Symbol Denitions
12 | ACIST | CVi Contrast Delivery System User's Guide 901479-002,01 2019-08
Use of Patient Kits
Failure to observe the following guidelines can result in patient injury or
equipment damage:
• Do not use a patient kit on more than one patient.
• Do not allow any consumable to sit unused for more than the
maximum time recommended by the contrast manufacturer.
• Do not allow a syringe kit that is loaded with contrast to sit longer than
the maximum time recommended by the contrast manufacturer.
• Do not use a multi-procedural syringe kit for more than ve cases.
• Dispose of all single-use components aer every case.
• Properly discard consumables 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 ACIST 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. 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. Do not immerse any components in water. Be sure that
the CVi System is completely dry before applying power.
Closed Stopcock
Never inject with the stopcock closed.
Warnings
(continued)

Warnings, Cautions, and Symbol Denitions
ACIST | CVi Contrast Delivery System User's Guide | 13901479-002,01 2019-08
Electrical Isolation
Connections to the patient are physically isolated from all CVi System power
sources. Follow facility procedures to ensure that there is no degradation of
CVi System electrical performance.
Emergency Shutdown
In the case of power blackouts, power brownouts, or voltage surges resulting
in abnormal system operation of any kind, immediately turn o the power
switch and detach from the patient.
Flammable Gases
Do not use the CVi System in the presence of ammable gases.
High Flow Rate Injections
Use extreme care when setting the ow rate. High ow rate injections can
cause patient injury or death. When a high ow rate injection is required,
select a pressure setting that does not exceed the patient catheter's pressure
rating.
Injection System Setting
Check the ACIST System settings before injection, and verify the
appropriateness of all injection parameters before injecting.
Mounting System
e use of non-approved mounting equipment can cause injury. Mount the
CVi System using only mounting assemblies approved by ACIST Medical
Systems.
Shock Hazard
Hazardous voltage exists within the CVi System. To avoid the risk of electric
shock, only trained, qualied personnel should service the CVi System.
Disconnect the system from the power source before service. Do not touch
the pins on the connectors or the cables.
System Messages
Respond appropriately to all system messages. If the message cannot be
cleared, contact an ACIST representative.
Safe Use of Equipment
• No modication of equipment is allowed.
• e ACIST|CVi Contrast Delivery System may only be interfaced with
X-ray equipment that is certied to be in compliance with IEC 60601-
1, second or third edition.
Warnings
(continued)

Warnings, Cautions, and Symbol Denitions
14 | ACIST | CVi Contrast Delivery System User's Guide 901479-002,01 2019-08
• To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth ground.
• To avoid the potential for electric shock to the patient, X-ray
equipment used in conjunction with the ACIST|CVi Contrast
Delivery System must provide two means of patient protection.
• To avoid the potential for electric shock to the patient, do not touch
the patient while making connections to the injector head or to the
power supply.
• To avoid the potential for electric shock, do not touch the patient and
the X-ray interface connector pins simultaneously.
• To meet the debrillator protection specied, the CVi System must be
used only with accessories (including transducers and adapter cables)
that are specied by ACIST Medical Systems.
e following precautions refer to hazards that could result in injury to the
patient or user or damage to the CVi System or other equipment. Read this
section carefully.
Accessories
For proper operation and to ensure equipment compatibility, use only
accessories and options provided or specied by ACIST Medical Systems for
use with the CVi System.
Bed Rail Mount
Failure to securely clamp the CVi System components to the bed rail may
result in serious injury or equipment damage. Mount equipment according to
the bed manufacturer’s recommendations. Before mounting the CVi System
on a bed rail, consult the bed manufacturer's specications to make sure that
the rail can support the system's weight.
Contrast Viscosity
To ensure proper operation of the syringe, viscosity limits must be observed.
Refer to the IFU that was shipped with the syringe kit for viscosity limits.
Control Panel Touch Screen
Touch the control panel screen in only one place at a time to avoid
inadvertently activating buttons.
Electromagnetic/Electrostatic Interference
e CVi System may fail to operate correctly if exposed to certain
electromagnetic elds (for example, radio transmitters, cell phones), or if
exposed to high levels of electrostatic discharge.
Cautions

Warnings, Cautions, and Symbol Denitions
ACIST | CVi Contrast Delivery System User's Guide | 15901479-002,01 2019-08
Excessive Injections
When performing a large number of either high-pressure, high-volume
injections or low-pressure, low-volume injections, the manifold valve may
begin to stick when resetting or opening. If this occurs, replace the patient kit.
Eye Protection
Always wear eye protection when using the CVi System.
Injection System Temperature
When the CVi System is brought in from extreme outside temperatures (hot
or cold), allow it to stabilize at room temperature for approximately one hour
before use.
Leakage Current
If the chassis leakage current is above 100 µA, do not use the CVi System.
Line Power
Before connecting the CVi System to an electrical outlet, check the power
source for proper voltage and frequency.
Lock Button
e CVi System is locked to its mount when the locking knob is tightened
fully clockwise. e system should remain locked to its mount except during
transfer between mounts (for example, transferring between a bed rail and a
wheeled cart).
Locking Wheels
To prevent unintentional movement of a CVi System that is mounted on a
wheeled cart, lock the wheels.
Mixing Hardware Components
Never mix and match hardware components from dierent injector system
models. Each model's components are designed to work together as a set.
Mounted System
Do not lean, grab, or place objects on the CVi System.
When transporting the CVi System on the pedestal cart, follow these
guidelines:
• Make sure that the safety latch knob is tightened fully clockwise, and
that the unit is secure on the cart.
• Make sure that the power supply is secured to the mounting bracket
during transport.
Cautions
(continued)

Warnings, Cautions, and Symbol Denitions
16 | ACIST | CVi Contrast Delivery System User's Guide 901479-002,01 2019-08
• Guide the system using the cart handrail only. Do not push the CVi
System.
• For power supplies that are o the patient table (bed) mount, be sure
that the power supply is in the cart tray during transportation.
Pressure Transducer
To avoid bursting the dome membrane on the pressure transducer backplate
and introducing air into the system, attach the disposable pressure transducer
to the backplate before applying positive pressure to the system.
Preventive Maintenance
For optimal performance of the CVi System, annual preventive maintenance
should be performed by an authorized ACIST Medical Systems representative.
Removing the Contrast Spike
When removing consumables, make sure the contrast spike is removed from
the contrast container prior to opening the syringe chamber.
Saline Pump
e tubing must be properly installed in the injector head and the rear tubing
guide must be lowered onto the tubing for proper operation of the saline
pump and the system.
Training
All qualied personnel who will be operating the CVi System should be
trained by a certied representative of ACIST Medical Systems.
X-ray Input Cable
To avoid damaging X-ray imaging equipment, make sure the connector on
the X-ray imaging device is properly congured before the input cable is
connected to the CVi System.
Cautions
(continued)

Warnings, Cautions, and Symbol Denitions
ACIST | CVi Contrast Delivery System User's Guide | 17901479-002,01 2019-08
e following symbols are used on the CVi System components and
throughout this manual:
Symbol Denition
Patient applied part, degree of protection against
electrical shock, type CF debrillation proof
Alternating current
Equipotentiality
Pushing prohibited
Consult instructions for use
Consult the instructions for use for important
cautionary information
Do not reuse
Keep dry
Humidity limitation
Pressure limitation
Temperature limitation
Fragile, handle with care
Non-pyrogenic
Manufacturer,
Date of manufacture
Date of manufacture
Symbol Denitions

Warnings, Cautions, and Symbol Denitions
18 | ACIST | CVi Contrast Delivery System User's Guide 901479-002,01 2019-08
Symbol Denition
Serial number
Catalog number
Lot number
Packaging Unit
Dangerous voltage
Explosion hazard
Do not tip
European representative
Contact for service
This product should be recycled and not disposed
of as general waste (subject to WEEE annex IV resp.
EN 50419).
In accordance with European Union WEEE Directive
2002/96/EC, ACIST Europe B.V. will be fully
responsible for the coordination, logistics, and costs
of the WEEE process.
With respect to electrical shock, re, mechanical,
and other specied hazards, only in accordance
with IEC 60601-1, second and third editions.
Complies with European Directive 93/42/EEC,
Medical Device Directive.
Do not use if packaging is damaged
Sterilized using ethylene oxide
Sterilized using irradiation
Symbol Denitions
(continued)

Warnings, Cautions, and Symbol Denitions
ACIST | CVi Contrast Delivery System User's Guide | 19901479-002,01 2019-08
Symbol Denition
PHT
DEHP
Contains DEHP
Environmental enclosure rating, protected against
objects greater than 12 mm and protected against
dripping water, injector head
General warning
Symbol Denitions
(continued)

20 | ACIST | CVi Contrast Delivery System User's Guide 901479-002,01 2019-08
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