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The ClearStar pump can be used for adult and pediatric patients provided the patients can tolerate a feeding range within the pump operational specifications. Those specifications are: - * The flow rate range is 1-300 ml/hr in I mL/hr increments - * The flow rate accuracy is ± 10% or ± 0.5 mL/hr, whichever is greater - * The occlusion pressure limit is 26-30 psi. If these specifications are not appropriate for a given patient, the ClearStar pump should not be used.

The ClearStar pump raises no new questions of safety or effectiveness above those currently associated with enteral feeding pumps. The operator's manual for the ClearStar pump provides warnings regarding volume sensitive patients similar to those found in the operating manuals of the Companion and Quantum enteral feeding pumps. The pump's automatic clog clearing function has been designed to ensure that the nominal pressure exerted on a clog is in the 26 to 30 psi range. Additionally, to ensure that the patient is not underfed, the pump, if unsuccessful in clearing a clog before ten (10) minutes have elapsed, will alarm occlusion. Finally, the pump can only be in the clog clearing mode a maximum of twenty (20) minutes or ten times in any consecutive four (4) hour period. If twenty (20) minutes or ten times are exceeded, the pump will alarm occlusion.