Users Manual Part 7

Appendix A
The pump can be worn in several ways: It can be placed in a pocket or attached to a belt by the included belt
clip accessory. There is no restriction on orientation or position of the pump relative to the infusion site.
Occlusion Detection Time:
• Rate: 16 µL/h Detection Time: 8 h
• Rate: 42 µL/h Detection Time: 8 h
The unintended Bolus volume following the release of an Occlusion is ≤40 µL (Typically <15 µL) for all delivery
rates.
Under single fault conditions no more than the following medication is delivered:
• 10 µL or, if greater,
• 50% error for deliveries ≤ 8 h
• 25% error for deliveries > 8 h
The system has not been evaluated for use in Oxygen Rich Environments and should not be used in an area
where oxygen is in use.
All parts of the Remunity
™
Pump for Remodulin
®
(treprostinil) Injection are rated for continuous operation.
• The Remunity
™
Pump for Remodulin
®
(treprostinil) Injection is INTERNALLY POWERED ME
EQUIPMENT.
• When the Remunity
™
Pump for Remodulin
®
(treprostinil) Injection remote interface is being charged it is
CLASS II and INTERNALLY POWERED at all other times.
DKPI-09153-001-Rev. 1.4 213