Integrated systems for testing and certifying the physical,...

Data processing: measuring – calibrating – or testing – Calibration or correction system – Fluid or fluid flow measurement

Reexamination Certificate

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Details

C702S045000, C702S050000, C702S114000

Reexamination Certificate

active

06757630

ABSTRACT:

FIELD OF THE INVENTION
The invention relates to systems and methods for testing the physical, functional, and electrical performance of pumps.
BACKGROUND OF THE INVENTION
There are many types and styles of pumps intended to administer liquids, medications, and solutions intravenously. Such pumps (commonly called “IV pumps”) operate in various ways; for example, by syringe, diaphragm, peristaltic, and fluid pressure action.
Because of their intended use, IV pumps must meet stringent requirements for accuracy and safety. IV pumps also require periodic certification of their physical, functional, and electrical performance characteristics.
Today, testing and certification of IV pumps are typically performed by facilities with trained technical staffs. The pump owner loses use of the pump during shipment of the pump to the test facility, and while the pump facility performs its services and ships the pump back.
There is a need for a system that a non-technical person can conveniently use to test and completely certify IV pump performance on site, without assistance of often distant test facilities.
SUMMARY OF THE INVENTION
One aspect of the invention provides a system that integrates in a straightforward and user-friendly manner the testing of different functional and performance characteristics of intravenous pumps.
In a preferred embodiment, the system includes a test station and a controller. The test station houses two functional components. The first component is adapted to be coupled in liquid flow communication with an external intravenous fluid pump. The second component is adapted to be coupled electrically to the pump. The controller operates the test station in two modes. In one mode, the first component is operated to test at least one specified liquid flow characteristic of the pump. In the other mode, the second component is operated to test at least one specified electrical safety characteristic of the pump. The controller generates a first test output regarding the specified liquid flow characteristic tested. The controller also generates a second test output regarding the specified electrical safety characteristic tests. In this way, the controller integrates not only the carrying out of the different tests, but the generation of the test results as well.
Another aspect of the invention provides a system for carrying out in a stepwise and orderly fashion one or more visual inspections of a functional element of an intravenous pump. This aspect of the invention provides a system having an output element for prompting an operator and an input element for receiving responses from the operator to prompting by the output element. The system also includes a controller coupled to the output element and the input element. The controller generates a prescribed test prompt that instructs the operator to visually inspect at least one specified functional element of the pump. The controller also governs the receipt of a test response from the operator to the test response. The controller generates a test output regarding the specified functional element based upon the test response.
The two just discussed aspects of the invention can be combined in an integrated multi-test system. In a preferred embodiment, a system includes a test station housing either a first component adapted to be coupled in liquid flow communication with an external intravenous fluid pump or a second component adapted to be coupled electrically to the pump, or both. The system also includes a controller coupled to the test station. The controller includes an output element for prompting an operator and an input element for receiving response from the operator to prompting of the output element. The controller operates the test station in one mode controlling the operation of the first component to test at least one specified liquid flow characteristic of the pump, or the second component to test at least one specified electrical safety characteristic of the pump, or both. The controller also operates the input and output elements in another mode to generate a test prompt instructing the operator to inspect at least one specified functional element of the pump and to receive a test response from the operator to the test prompt. The controller generates integrated test results. Test outputs concern the specified liquid flow and/or electrical characteristics tested by the test station. Another test output concerns the specified functional element based upon the visual test responses of the operator.
In preferred embodiments of these various aspects of the invention, the specified liquid flow characteristic includes liquid flow rate and liquid occlusion pressure.
In these preferred embodiments, the system also includes a reporting station coupled to the controller for communicating at least one of the test outputs on alpha or numeric or alpha-numeric format. The controller also preferably includes memory for storing at least one of the test outputs in a database and means for sorting the database according to specified criteria and generating a sorted output, which can be reported in alpha or numeric or alpha-numeric format.
Another aspect of the invention provides a system for testing and certifying an intravenous fluid pump. The system includes a test station adapted to be coupled to the pump and a processing station coupled to the test station. The processing station has memory for storing in a database a desired operating characteristic for the pump coupled to the test station. The processing station also includes a controller for operating the test station to obtain an actual operating characteristic measured by operating the pump while coupled to the test station. A comparator in the processing station compares the actual operating characteristic to the desired operating characteristic and generates a certification output based upon the comparison.
In a preferred embodiment, the system includes a reporting station for communicating the certification result in alpha or numeric or alpha-numeric format in a certification report. The reporting station also preferably communicates the actual operating characteristics in alpha or numeric or alpha-numeric format in a test results report.
The systems following the various aspects of the invention, alone or in combination, make it possible for non-technical people to perform testing and recertification of IV pumps on site at pump distribution centers and hospitals. The systems eliminate the need to send IV pumps to specialized bio-medical facilities for certification. In this way, the systems avoid lost time and expense due to shipping, staging time at the certification facility, and returning the certified pumps to inventory.
Other features and advantages of the inventions are set forth in the following specification and attached drawings.


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Brochure A Prior Art, medTester 1000B, (Ele

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