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510(k) Data Aggregation

    K Number
    K011868
    Device Name
    ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS
    Manufacturer
    Date Cleared
    2001-09-04

    (82 days)

    Product Code
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEBIOTECH S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Enteral Expres enteral fluid delivery system is intended to provide delivery of standard enteral nutrition fluids to patients in the hospital and in alternate site care.
    Device Description
    The Enteral Expres enteral feeding pump system is intended for the programmed delivery of enteral nutrition fluids to the patient. It may be used in hospitals, outpatient, or home healthcare sites on immobilized or ambulatory patients. The "Enteral Exprés" system offers the following capabilities: CONTINUOUS, PROGRESSIVE, and PROGRESSIVE INTERMITTENT delivery modes to meet different patient needs; Wide range of programmable delivery rates: from 1 to 999 mL/hr; One way, snap-in cassette simplifies giving set loading; Safety features that help prevent tampering with the pump include keypad lock and program lock; Keypad and display are simple and easy to use, and display provides English or Spanish information; Battery or AC-powered operation. Battery life monitored by internal battery gauge; Small, quiet, and lightweight to enhance patient comfort. The Enteral Expres pumping mechanism is comprised of a cassette assembly and the pump. The majority of the pumping mechanism is incorporated into the cassette assembly, with the motor and it's controlling electronics and shaft being incorporated in the pump. The cassette incorporates three rollers and a length of silicone tubing housed in a closed cassette assembly. Loading the cassette onto the motor shaft causes the rollers to expand outward, crushing the tubing against the inside walls of the cassette body and occluding ourity flow through the system. As the motor shaft rotates, the rollers rotate and the crushed portion of the tubing translates across the inner circumference of the cassette body. This portion of the tuones attiblements action. The accuracy of the system is largely determined fesults in a rotal y persuative pulliging assist of the inner diameter of the tubing is the primary factor in determining the volumetric output per rotation. Within the pump the motor is directly coupled to the drive shaft through a sprag clutch to writting the punp the motor is controlled by the microprocessor and redundant province is used to verify the proper rotation of the shaft. The accuracy of the motor's rotation entently is as a long onchronizing the signal from the motor's encoder with a signal generated by a programmable frequency divider. The accuracy of the frequency divider is monitored by an independent microprocessor clock circuit. Microprocessor integrity is, in turn, monitored with self-check routines and watchdog circuitry.
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