Users Manual Part 7

Technical Specifications
The Remunity
Pump for Remodulin
®
(treprostinil) Injection consists of two main components; a wearable
pump and a hand held remote. These two subsystems communicate via radio.
The remote provides a means of programming/controlling the pump and viewing data logs.
The pump is designed to deliver Remodulin subcutaneously based on a programmed delivery rate, and is to
be worn for up to three days at a time. The medication deliveries are made even when the pump is not in
communication with the hand held remote. When the pump is not in communication with the hand held
remote, fault detection and alarm generation is intact.
The pump is composed of a reusable portion and disposable portion. The reusable portion contains volume
measurement hardware, pump actuation hardware, and electronics. The pump is powered by a rechargeable
battery.
The disposable portion of the pump is the cassette, which includes an infusion set connector. The cassette
consists of chambers for storing, pumping and measuring fluid. In addition the cassette contains valves used
to control the flow of medication.
The combination of the pump and cassette chambers actively draw up to 2 µL aliquots of medication from the
storage chamber in the reservoir, measure the volume of each aliquot, then deliver these aliquots into the
patient. These individual measurements are used to accurately deliver medication and detect occlusions.
The pump infuses medication though a separately supplied infusion set and catheter.
Appendix A
212 DKPI-09153-001-Rev. 1.4