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510(k) Data Aggregation
K Number
K031199Device Name
ENTERALITE INFINITY ENTERAL FEEDING PUMP
Manufacturer
ZEVEX INTL., INC.
Date Cleared
2003-07-09
(86 days)
Product Code
LZH
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
ZEVEX INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EnteraLite® Infinity™ Enteral Feeding Pump is a rotary peristaltic pump designed to deliver programmed doses of enteral nutrition solutions at selectable rates.
Device Description
The EnteraLite® Infinity™ Enteral Feeding Pump as referred to as Infinity™ with disposable set is a small, lightweight pump used to dispense liquid nutrients at a user controlled rate to patients. The device may be used in the hospital or at home by bedridden or ambulatory patients. The device is also designed for use with pediatric patients.
The device is a software controlled, variable flow rate, peristaltic pump. It operates up to 24 hours (at a nominal flow rate of 125 ml/hr) from internal rechargeable batteries. The batteries are recharged by a wall mounted charger that plugs into a standard 100 to 240 volt alternating current wall socket. The charger is available in various input voltage and plug configurations to accommodate international requirements. The charger converts line voltage to a safe low voltage of 5 volts DC that is supplied from the charger to the pump. A "fuel gauge" type indicator on the pump's LCD display continuously shows the state of battery charge.
The pump motor runs at a single speed and is turned on and off at programmed intervals to obtain the desired flow rate. The motor drive circuit is controlled by a microcontroller that allows the motor to pause longer at lower flow rates with correspondingly shorter pauses at higher flow rates. The software embodied within the microcontroller is extensively validated and verified as part of the design process.
The pump includes several safety features. An air-in-line sensor rapidly detects whenever nutrient flow is interrupted and alerts the user with both a visual and audible alarm. Two pressure sensors detect occlusions both on the nutrient bag (distal) side and the patient (proximal) side of the pump. The user is alerted to proximal or distal occlusions by both visual and audible alarms.
The disposable tubing set consists of a bag, or spike for nutrient bag, DEHP free PVC connecting tubing, an integral cassette with a silicone pumping segment, and an enteral adapter. The set also contains a patented anti-free flow device within the cassette, a version of which is used in the stationary pumps manufactured by ZEVEX, which prevents free flow of fluids if the tubing set is inadvertently or purposely removed from the pump.
A backpack (convertible to a waistpack) is available for use under ambulatory conditions. The pump may be operated in any orientation.
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K Number
K954735Device Name
ENTERALITE
Manufacturer
ZEVEX INTL., INC.
Date Cleared
1996-04-15
(182 days)
Product Code
LZH
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
ZEVEX INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Enteral ite enteral feeding pump with disposable set is a small, lightweight pump used to dispense liquid nutrients at a user controlled rate to patients. The device may be used in the hospital or at home by bed-ridden or ambulatory patients.
Device Description
The Enteral ite enteral feeding pump with disposable set is a small, lightweight pump used to dispense liquid nutrients at a user controlled rate to patients. The device may be used in the hospital or at home by bed-ridden or ambulatory patients. The device is also designed for use with pediatric patients.
The device is a software controlled, variable flow rate, peristaltic pump. It operates up to 24 hours (at a nominal flow rate of 125 ml/hr) from internal rechargeable batteries. The batteries are recharged by a wall mounted charger that plugs into a standard 120 volt alternating current wall socket. The charger is available in various input voltage and plug configurations to accommodate international requirements. The charger converts line voltage to a safe low voltage of 12 volts DC that is supplied from the charger to the pump. A "fuel gauge" type indicator on the pump's LCD display continuously shows the state of battery charge.
The pump motor runs at a single speed and is turned on and off at programmed intervals to obtain the desired flow rate. The motor drive circuit is controlled by a microcontroller that allows the motor to pause longer at lower flow rates with correspondingly shorter pauses at higher flow rates. The software embodied within the microcontroller was extensively validated and verified as part of the design process.
The pump includes several safety features. An air-in-line sensor rapidly detects whenever nutrient flow is interrupted and alerts the user with both a visual and audible alarm. Two pressure sensors detect occlusions both on the nutrient bag (distal) side and the patient (proximal) side of the pump. The user is alerted to proximal or distal occlusions by both visual and audible alarms.
A backpack (convertible to a fannypack) is available for use under ambulatory conditions. The pump may be operated in any orientation.
The ZEVEX disposable nutrient administration set is comprised of nine components. All components of the set remain extracorporeal. The ZEVEX set interfaces with the in vivo apparatus via an industry standard non-I.V. compatible stepped adapter. The disposable set includes a short length of silicone tubing that is stretched around the three feeding purno rollers. As the rollers turn, they occlude the tubing forcing the nutrient solution through the silicone pump tube. The set also includes a unique fail safe device that precludes free-flow when the set is not correctly installed in the pump with the door closed. Pull tests were done to assure that the set would not be easy to inadvertently disconnect when in use.
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