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ulrichINJECT CT motion is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in computed tomography (CT) applications.

ulrichINJECT CT motion is specifically indicated for use in CT procedures for the delivery of the following contrast media:

• Iohexol Injection in single-dose (SD) container or Imaging Bulk Package (IBP)
• Iodixanol Injection in SD container
• Iopamidol Injection in IBP

Pump tubing – flex can be used with a maximum of 36 bottles of contrast media or a maximum time of twenty-four (24) hours, whichever comes first.

Use time expiration per SD container is a maximum of four (4) hours from initial puncture, unless otherwise stated by the contrast media labeling.

Use time expiration per IBP is limited to a maximum time stated by the specific contrast media labeling.

Use time expiration per saline container is a maximum of twenty four (24) hours from initial puncture.

Spike for CT disposable is for single-bottle use only and must be discarded with the media container. The maximum time usage for the Spike for CT is twenty four (24) hours, or the maximum use time for the contrast media container indicated for use with ulrichINJECT CT motion, whichever comes first.

The Patient tubing must be discarded after each patient procedure.

SYNCopen is indicated for the specific purpose of allowing an injector to interface with a CT scanner.

RIS/PACS is indicated for the specific purpose of allowing an injector to interface with a Radiological Information System (RIS) and a Picture Archiving and Communications System (PACS).

ulrichINJECT CT motion is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast media.

ulrichINJECT CT motion is a syringeless contrast media management system that is designed for the controlled, automatic administration, on the venous side, of contrast media and saline, to human subjects undergoing diagnostic examinations in computed tomography (CT) applications.

The ulrichINJECT CT motion system consists of a terminal, injector, and tubing system. The tubing system is the only component that comes in contact with the patient and has indirect contact with the blood path of a patient for a limited duration (<24 hours). The tubing system consists of the following three (3) components:

• Spike for CT (CM/NaCl);
• Pump tubing – flex; and
• Patient Tubing.

ulrichINJECT CT motion uses a peristaltic pump as part of the injector which is designed to transport the media fluid through the tubing system (spikes, pump tubing – flex, and patient tubing). ulrichINJECT CT motion is intended to be used with the following components that are not supplied with the system:

• Saline containers,
• Single-dose contrast media containers,
• Imaging Bulk Package (IBP) contrast media containers, and
• Cannula.

ulrichINJECT CT motion is equipped with multiple hardware and software controls that work together for the safe operation of the intended use of the system. Controls include air detectors to detect the presence of air in the tubing system without direct contact with the medium, pressure controls to manage and regulate pressure inside the tubing system, and check valves to prevent backflow of media and avoid retrograde contamination.

The ulrichINJECT CT motion is provided in two versions:

• Mobile pedestal version
• Ceiling version

The mobile pedestal version consists of the injector head and the injector base with rechargeable battery. The ceiling version consists of the injector head, a fixed-height arm, and a movable arm.

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