
3 - 10
MEDRAD® MRXperion
3.2 Cautions
Patient and/or worker injury or equipment damage may result.
Q
The workstation (control room unit) is MR unsafe and is not for use in the scan room. The workstation is a known threat or poses
a hazard in all MR environments as defined by the ASTM International Standards for MRI Device Marketing.
Q
The Injector (scan room unit) and power supply are MR conditional. The scan room unit and power supply have been
demonstrated to pose no known hazards in a specific MR environment with specified conditions of use as defined by the ASTM
International Standards for MRI Device Marketing.
Q
Do not make any unauthorized modifications to the injector or any of its parts.
Mechanical Hazard - Serious patient injury could result from fluid leaks or tubing ruptures during an injection.
Q
Use only disposables or accessories supplied by Bayer. Refer to
"Chapter 19 - Options and Accessories"
for more information.
Q
Use only syringes and tubing with a pressure rating greater than the maximum programmable pressure limit of the injection
system, which is 325 psi (2241 kPa).
Q
Ensure that the fluid path is open and do not use syringes and tubing rated below 350psi (2410 kPa). An occlusion in the fluid
path and/or use of syringes or tubing rated below 350 psi (2410 kPa) may result in leaks or ruptures.
Q
Use catheters with pressure ratings compatible with this system. Refer to
"Section 18.9.2 - Maximum Flow Rate Performance"
"Section 18.5 - System Capabilities"
for programmable pressure limit options.
Q
Patient injury and/or catheter damage may result from using tubing set that is too short. Operator must consider tubing length
and stretch limitations when moving the injector or the patient.
CAUTIONS
Mechanical Hazard - Minor or moderate patient and/or worker injury may result.
Q
Only use the system as defined in this manual. Follow the instructions given in system communication or fault messages.
Q
Do not use the system in the presence of flammable (such as anesthetics) or combustible gases or other agents.
Q
Use only non-magnetic tools to install any scanner/magnet room components.
Q
Dispose of system components and accessories according to local regulations or contact Bayer.
Q
When moving the system, hold the pedestal no higher than 45inches (114.3 cm) above the floor.
Electric Shock Hazard - Minor or moderate patient and/or worker injury may result.
Q
Only plug the system into a direct mains access point.
Q
Make sure the direct mains access point is accessible during operation of the system.
Q
Do not plug the system power cords into an extension cord or multi-outlet power strip.
Q
Verify that the voltage and frequency as labeled matches the voltage and frequency of the electrical outlet.
Q
Use only Bayer-approved accessories.
Do not adjust or transport the system with fluid containers attached. Minor or moderate patient and/or worker
injury may result.
Q
The fluid containers and/or holder may fall, causing patient injury and/or property damage.
Q
Attach containers only after the system is in a stationary position.
WARNINGS
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