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510(k) Data Aggregation
K Number
K011587Device Name
SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP
Manufacturer
ENTRACON CORP.
Date Cleared
2001-06-01
(9 days)
Product Code
LZH
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
ENTRACON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The enteral feeding pump accurately controls the flow of liquid feeding solution to patients who are unable or unwilling to consume adequate nutrients. Liquid feedings may consist of commercially prepared formulas or blenderized foods and are most often delivered by means of nasogastric, nasoduodenal of nasojenjunal feeding tubes. In some cases a surgically placed esophagostomy, gastrostomy or enterostomy tube may be used. The pump is not intended for use with blood or blood products. The pump is not for intravenous delivery.
Device Description
The SENTINEL / LH2001 is a peristaltic pump intended for controlled delivery of liquid nutrients. The pump requires cleared disposable delivery tube sets approved by ENTRACON CORPORATION. The pump is used to feed hospital or long term care patients. The microprocessor controlled pump operates while normally connected to a 120 VAC outlet. In the event of AC power loss, or when moving patients, the pump operates on an internal backup battery. The battery is always being charged by during AC power use. With a fully charged battery, the pump can operate for 12 hours at a set delivery rate of 125 ml/hr. The pumping mechanism is a rotor, driven by a stepper motor. The stepper motor runs at a constant speed with delivery rate dependent on on/off timing. The pump includes an integral pole clamp for securing it, typically to an IV pole. Visual and auditory alarms warn of flow-related problem conditions; either occluded flow or excessive flow. Flow detection is accomplished by optically sensing falling drops of nutrient in the pump-mounted drip chamber. Additionally, other warning actions occur when liguid nutrient container is empty, when the pump has completed delivery of a preprogrammed dose, when the pump has been idle for more than 2½ minutes, or when, during battery operation, the battery requires recharging.
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