Transcription of PROMETRA® II PROGRAMMABLE PUMP (REF 13827)
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PROMETRA II PROGRAMMABLE PUMP ( ref 13827 ). For use with Intrathecal Catheter MR Conditional Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. Table of Contents 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.
• The presence of infection is known or suspected. • The patient’s body size or anatomy is insufficient to accommodate the size of the implanted pump
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