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PROMETRA® II PROGRAMMABLE PUMP
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Introduction
The Prometra II Programmable Pump is designed to provide controlled delivery of Infumorph
®
to the
intrathecal space via the separately supplied Intrathecal Catheter. The Prometra II Pump incorporates
a patented flow activated safety valve (FAV™) that will shut off drug flow to the patient in the event
that a high flow rate is encountered. The Prometra Programmer is a separately supplied handheld,
menu-driven device that enables remote programming of the Prometra II Pump.
Note: The use of the terms “medication” and “drug” throughout this document refer to the use of
Infumorph.
Contents
The following components are sterile and non-pyrogenic:
1 – Prometra II Programmable Pump
1 – Needle, Non-Coring, 0.7 mm (22G) x 38 mm (1.5 in.)
1 – Needle, Catheter Access, 0.9 mm (20G) x 45 mm (1.75 in.)
Non-sterile components:
1 – Patient and Physician Information Packet:
1 – Instructions for Use
1 – Calculations Guide
1 – Patient Guide
2 – Temporary Patient Implant Cards
1 – Sheet of Device ID Stickers
1 – Patient Device Tracking Form
1 – Warranty Card
Description
The Prometra II Pump is a battery-powered, teardrop-shaped pump with a rigid titanium housing and a
triple redundancy flow controller system. To help increase safety, the Prometra II Pump incorporates
a safety valve (flow-activated valve or FAV) that will shut off drug flow to the patient in the event a
high flow rate occurs.