PROMETRA® II PROGRAMMABLE PUMP
Page 8 of 38
Magnetic Resonance Imaging (MRI)
Prometra
®
and Prometra
®
II Programmable Pumps Magnetic
Resonance Imaging (MRI) Instruction Guide
GENERAL
MR Conditional
WARNING: FAILURE TO EMPTY THE PUMP PRIOR TO EXPOSURE TO MRI ENVIRONMENT
COULD RESULT IN DRUG OVERDOSE THAT COULD LEAD TO SERIOUS PATIENT INJURY OR
DEATH.
Warning: Patients should not be exposed to MRI environments until the surgical site following
pump implantation is fully healed.
Warning: EMPTY ALL DRUG SOLUTION FROM BOTH PROMETRA AND PROMETRA II PUMPS PRIOR
TO ENTERING THE MRI ENVIRONMENT. If a patient with a Prometra II Pump requires an
emergent MRI, please see page 13 of these instructions for more details on the potential risks
involved.
Strong magnetic fields, such as those created in MRI scanners, may cause the Inlet and Outlet
Valves to open, resulting in the immediate discharge of the contents of the Drug Reservoir and
Catheter into the patient. This could result in drug overdose that could lead to serious patient
injury or death.
Prior to initiating the MRI procedure, the physician must determine if the patient can safely be deprived of
medication for the length of the MRI procedure. If medication is needed, then alternate means of drug
delivery (such as I.V. administration) should be employed for the duration of the MRI procedure.
Prior to scheduling an MRI scan and upon its completion, pump status should be confirmed by inquiring the
pump to verify pump operation and settings.
Note: Pre-MRI, Post-MRI, and Medical Emergency Use instructions are provided in this document.
SCANNING PARAMETERS
The Prometra
®
and Prometra
®
II Programmable Pumps can be safely exposed to an MRI system when ALL of
the following conditions are met:
1.
The MRI device has a static magnetic field of 1.5 Tesla.
2.
The MRI device has a maximum spatial gradient field of 2,000 Gauss/cm (20 T/m) at 1.5 Tesla.
Warning: Exceeding the 2,000 Gauss/cm (20T/m) at 1.5T limit could result in excessive force or
torque which could lead to patient injury.
