Bayer HealthCare CERTEGRA MEDRAD Stellant FLEX Operation Manual page 3

Operation Manual i
MEDRAD® Stellant FLEX CT Injection
System with Certegra® Workstation
Operation Manual
The MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation has an expected service life* of 7 years
from the date of product installation when operated according to the instructions provided with this device. These 7
years include suggested or mandatory actions of preventative maintenance and repair activities, as well as required
calibration(s) that are needed. Required reading includes the instructions for use and other materials provided with
the device. This also includes any hardware and software updates that may be required.
*Expected Service Life: The length of time that an individual unit, lot, or batch of devices is expected to remain
functional after it is placed into use.
Report any serious incident that has occurred in relation to this device to Bayer (radiology.bayer.com/contact) and to
your local European competent authority (or, where applicable, to the appropriate regulatory authority of the
country in which the incident has occurred).
A glossary of the symbols used on the MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation can
be found in Section 2 of this manual.