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Flowonix Prometra II User Manual

Flowonix Prometra II
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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.
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Flowonix Prometra II Specifications

General IconGeneral
BrandFlowonix
ModelPrometra II
CategoryMedical Equipment
LanguageEnglish

Summary

Specifications

Indications

Contraindications

Lists conditions under which device implantation is contraindicated.

Warnings

General

Provides crucial safety warnings regarding drug use, MRI, and handling.

Magnetic Resonance Imaging (MRI)

GENERAL

States the device is MR Conditional and provides initial warnings.

SCANNING PARAMETERS

Details the conditions for safe MRI scanning (Tesla, gradient, SAR).

SPECIFIC PRE-MRI INSTRUCTIONS

Pre-MRI Procedure

Outlines the steps to prepare the pump before an MRI scan.

SPECIFIC POST-MRI INSTRUCTIONS

Post-MRI Procedure

Details the steps to take after an MRI scan for pump status confirmation.

IN THE EVENT OF A MEDICAL EMERGENCY REQUIRING AN MRI SCAN

Prometra II Programmable Pump (REF 13827)

Guidelines for the Prometra II pump during an emergency MRI.

Emergency Procedure PRE-MRI Steps for Prometra II Pump

Pump Inquiry

Steps for inquiring the pump status before an MRI.

Pump Programming

Steps for programming the pump to 0.0 mg/day before MRI.

Emergency Procedure POST-MRI Steps for Prometra II Pump

Confirm Pump Operational Status

Verifying pump operation and settings after an MRI.

Precautions

General

General precautions for reading instructions and handling the device.

Implant

Precautions related to the implantation procedure and technique.

Potential Adverse Events

Possible Risks Associated with Programmable Implantable Pump

Lists potential risks related to the pump itself.

Possible Risks Associated with Intrathecal Catheter

Lists potential risks associated with the intrathecal catheter.

Pump Operation

Programming Medication Regimens

Explains how to program medication delivery rates and modes.

Pre-Programmed Pump Settings

Pump Alarms

Implantation Instructions

Pre-Implant Pump Programming Set Up

Guides on setting up the pump programmer before implantation.

Pump Priming

Standard Priming Technique

Step-by-step guide for the standard pump priming method.

Implantation of the Intrathecal Catheter

Implantation of the Prometra II Programmable Pump

Guides on sterile technique for implanting the pump.

Pump Explantation