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510(k) Data Aggregation
K Number
K972740Device Name
HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01)
Manufacturer
HIMEX PRODUCTION CORP.
Date Cleared
1998-02-06
(199 days)
Product Code
KFM
Regulation Number
870.4360Why did this record match?
Applicant Name (Manufacturer) :
HIMEX PRODUCTION CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HIMEX Centriflow System is indicated for use in the maintenance of vital circulatory support as an extracorporeal circuit that is intended for use in cardiopulmonary bypass procedures less than six hours in duration.
Device Description
The HIMEX Centriflow ™ is a speed controlled motor device for operating a Nikkiso HMS-12 (FDA 510(k) # K920077) disposable centrifugal pump head. The motor turns a driver magnet at a speed that is set by the device operator. The Driver Magnet magnetically couples to a magnet inside the Nikkiso HMS-12 disposable pump module. Rotation of the Driver Magnet thereby causes the impeller inside the Nikkiso HMS-12 to turn. The device also provides monitoring of motor speed, fluid flow, temperature and pressure through the use of numeric displays, graphical displays, audible alarms and visible alarms.
The HIMEX Centriflow™ is a modular device consisting of a console and a Remote Driver Module. A dual microprocessor configuration is used to control and monitor the speed of a brushless DC motor. The primary microprocessor, located in the console, generates the primary motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The secondary microprocessor. located in the Remote Driver Module with the motor, generates the backup motor control signal, tracks motor usage, and displays motor speed. In the event of an error in the primary microprocessor control signal the secondary microprocessor will take control of the motor and lockout the primary microprocessor. Manual override is also provided to allow the operator to take direct control by overriding both microprocessors.
An array of hall sensors in the motor are used to determine motor speed. An ultrasonic flow meter is provided to monitor the pump output. A strain gauge air pressure transducer is provided to monitor outlet pressure. A connection is provided to accommodate a temperature probe to monitor temperature. The primary microprocessor acquires the sensor data for use in generating operator displays and alarms. Self illuminating numeric readouts are used to display monitored data. A liquid crystal graphics screen is used to display system options, menus. Operator setable alarms and parameters are accessible via the system menus. Two accessory digital timers are also provided.
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