ACIST CVi - Introduction to the ACIST CVi System

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