Warnings, Precautions, And Notices; Warnings - Bayer HealthCare CERTEGRA MEDRAD Stellant FLEX Operation Manual

Operation Manual
3

Warnings, Precautions, and Notices

3.1 - Warnings

3.2 - Cautions
3.3 - Notices
3.1 Warnings
WARNINGS
Air Embolism Hazard - Serious patient injury or death may result.
Use only disposables or accessories supplied by Bayer. Refer to
Use catheters and connectors with pressure ratings compatible with this system. Refer to
Maximum Flow Rate Performance
Environmental Contamination Hazard - Serious patient or worker injury or death may result.
Visually inspect all components before use.
Do not use damaged components.
Electric Shock Hazard - Serious patient and/or worker injury or death may result.
The system should be opened and serviced by qualified service personnel only.
Only use the power cord supplied with the system.
Equipment must only be connected to a supply mains with protective earth.
Fire hazard - Serious patient and/or worker injury or death may result.
Use the correct fuse type replaced by Bayer or personnel trained by Bayer.
Applicable Restrictions - Serious patient injury or death may result.
Do not use this system to deliver any fluid other than intravenous contrast media and common
flushing solutions.
This device is not intended for drug infusions, chemotherapy, or any other use for which the device is
not indicated.
Handle and use contrast media and saline per the manufacturers' instructions.
Hazard
Do not service or perform maintenance on the injection system while in use with a patient.
Reuse of single-use fluid sources may result in biological contamination.
Refer to the fluid source manufacturers' Instructions for Use.
Mechanical Hazard – Serious patient injury could result from leaks or ruptures during an injection.
Use only disposables supplied by Bayer. Refer to
Use only syringes and connector tubing with a pressure rating greater than the maximum
programmable pressure limit of the injection system, which is 325 psi (2241 kPa).
Use catheters with pressure ratings compatible with this system. Refer to
Rate Performance
and 17.7.3 - Programmable Pressure System
and 17.7.3 - Programmable Pressure System
16.6 - Sterile Disposables.
16.6 - Sterile Disposables.
17.7.2 - Maximum Flow
Performance.
3 - 11
17.7.2 -
Performance.