PROMETRA® II PROGRAMMABLE PUMP
Page 2 of 38
Table of Contents
Introduction ................................................................................................................ 3
Contents ..................................................................................................................... 3
Description ................................................................................................................. 3
Indications .................................................................................................................. 6
Drug Information ........................................................................................................ 6
Contraindications ........................................................................................................ 6
Warnings .................................................................................................................... 7
General .......................................................................................................................... 7
Magnetic Resonance Imaging (MRI) ............................................................................. 8
Precautions ............................................................................................................... 19
General ........................................................................................................................ 19
Implant ........................................................................................................................ 19
Device Compatibility ................................................................................................... 19
Potential Adverse Events .......................................................................................... 20
Clinical Studies .......................................................................................................... 22
Results ......................................................................................................................... 22
Equipment ................................................................................................................ 23
Pump Operation ....................................................................................................... 23
Programmable Features ............................................................................................. 23
Programming Medication Regimens .......................................................................... 24
Pre-Programmed Pump Settings ................................................................................. 26
Pump Alarms ............................................................................................................... 27
Implantation Instructions .......................................................................................... 28
Pre-Implant Pump Programming Set Up .................................................................... 28
Pump Priming Preparation .......................................................................................... 28
Pump Priming .............................................................................................................. 30
Implantation of the Intrathecal Catheter ................................................................... 31
Implantation of the Prometra II Programmable Pump ............................................... 31
Patient Implant Card and Registration ....................................................................... 33
Pump Explantation .................................................................................................... 33
Calculations .............................................................................................................. 34
Patient-Related Variables and Flow Rate Accuracy .................................................... 34
Geographical Elevation ............................................................................................... 34
Temperature Variation ............................................................................................... 35
Flow Rate Accuracy ..................................................................................................... 36
Device Longevity ......................................................................................................... 37
Drug Stability............................................................................................................... 37
