Users Manual Part 1

21% of pump samples alarmed due to early
detection of reservoir depletion resulting from an
addressable manufacturing defect but did not
affect the overall reliability of the devices.
No action, other than acknowledgment of the
attention alarm/alarm, was required for the
remaining attention alarm/alarm. The pump
alarmed as expected during the course of the
study, and would have prompted the user to take
appropriate action (e.g., restart the pump, switch to
the spare pump). There were no safety concerns
related to use of the Remunity Infusion System
during the study.
Essential Performance
The following items are the Essential Performance of
theRemunity
™
Pump for Remodulin
®
(treprostinil)
Injection:
• Deliver Remodulin to the patient per
specification when operating normally.
• Stop delivery to the patient in the presence of a
Pump fault.
• Provide the user with audio alarms directly from
the Pump.
• Detection of occlusions in the fluid path during
Remodulin delivery.
• Limit bolus volumes resulting from the clearing
of an occlusion to the published levels in this
document.
• Provide the OPERATOR with the ability to stop a
therapy.
10 DKPI-09153-001-Rev. 1.4