Operation and verification of a portable clinical analysis system

Abstract

The present invention covers the integration and utility of accelerometer features into a clinical analysis system. For example, measurement of dynamic acceleration and orientation of a blood-testing instrument with respect to Earth's gravitational field may be used to determine reliability of a test procedure and optionally to provide corrective elements thereof.

1 . A portable clinical system for in vitro analysis, the portable clinical system comprising:
 a cartridge configured to perform an in vitro analytical test; and   an analyzer comprising
 a port configured to receive the cartridge, 
 a measurement module interfacing with the cartridge inserted into the port, the measurement module configured to perform a test cycle on the cartridge to conduct the in vitro analytical test on a sample, thereby generating a vibration profile for the test cycle of the cartridge; and 
 a computing device configured to:
 compare the generated vibration profile for the test cycle of the cartridge with a pre-established vibration profile, 
 determine whether the generated vibration profile for the test cycle of the cartridge deviates from the pre-established vibration profile, and 
 based on the comparison of the test cycle of the cartridge with the pre-established vibration profile, indicate whether the analyzer is functioning properly. 
 
   
     
     
         2 . The portable clinical system of  claim 1 , wherein the pre-established vibration profile is a typical vibration profile for a similar cartridge. 
     
     
         3 . The portable clinical system of  claim 1 , wherein the vibration profile for the test cycle of the cartridge comprises vibration from movement of one of more plungers of the analyzer when the analyzer performs the test cycle on the cartridge. 
     
     
         4 . The portable clinical system of  claim 1 , wherein the vibration profile for the test cycle of the cartridge comprises acceptable variation from the pre-established vibration profile. 
     
     
         5 . The portable clinical system of  claim 1 , wherein the computing device is further configured, in an event when the vibration profile for the test cycle of the cartridge deviates from the pre-established vibration profile, to perform one or more of the following action: to indicate that preventive maintenance of the analyzer is required, to log the event, to send a notification to an operator of the analyzer, to perform maintenance of the portable clinical system, or to prevent reporting of result of the in vitro analytical test generated during the test cycle of the cartridge. 
     
     
         6 . The portable clinical system of  claim 1 , wherein the analyzer comprises an accelerometer detecting the vibration profile for the test cycle of the cartridge. 
     
     
         7 . The portable clinical system of  claim 6 , wherein the accelerometer is configured to collect acceleration data during the test cycle of the cartridge. 
     
     
         8 . The portable clinical system of  claim 7 , wherein the acceleration data comprises vibration characteristics of the measurement module. 
     
     
         9 . A portable clinical system for in vitro analysis, the portable clinical system comprising:
 a cartridge configured to perform an in vitro analytical test; and   an analyzer comprising
 a port configured to receive the cartridge, 
 a measurement module interfacing with the cartridge inserted into the port, the measurement module comprising a contact switch activated by the cartridge when the cartridge is inserted correctly in the port; and 
 a computing device configured to monitor status of the contact switch and to initiate a test cycle of the cartridge to conduct the in vitro analytical test on a sample when the contact switch is activated. 
   
     
     
         10 . The portable clinical system of  claim 9 , wherein the computing device is further configured to monitor the status of the contact switch to detect removal of the cartridge from the port. 
     
     
         11 . The portable clinical system of  claim 9 , wherein the cartridge comprises a latch engaged by the analyzer when the cartridge is fully inserted and generating a signature vibration profile detectable by the analyzer. 
     
     
         12 . The portable clinical system of  claim 11 , wherein the analyzer comprises an accelerometer detecting the signature vibration profile. 
     
     
         13 . The portable clinical system of  claim 11 , wherein the computing device is further configured to compare the signature vibration profile to a pre-established vibration profile and, based on the comparison, to determine whether the cartridge is fully engaged by the analyzer. 
     
     
         14 . The portable clinical system of  claim 13 , wherein the computing device is further configured, in an event when the signature vibration profile deviates from the pre-established vibration profile, to perform one or more of the following actions: to log the event, to send a notification to an operator of the analyzer, or to prevent reporting of result of the in vitro analytical test generated during the test cycle of the cartridge. 
     
     
         15 . A method comprising:
 inserting a cartridge configured to perform an in vitro analytical test on a sample into a port of an analyzer;   using a measurement module of the analyzer interfacing with the inserted cartridge and a computing device connected with the analyzer,
 determining whether the cartridge is inserted correctly in the port, wherein the measurement module comprises a contact switch activated by the cartridge when the cartridge is inserted correctly in the port, and wherein the computing device is configured to monitor status of the contact switch and to initiate a test cycle of the cartridge to conduct the in vitro analytical test on a sample when the contact switch is activated, and/or 
 performing a test cycle on the cartridge to conduct the in vitro analytical test on the sample, thereby generating a vibration profile for the test cycle of the cartridge, wherein the computing device is configured to compare the generated vibration profile for the test cycle of the cartridge with a pre-established vibration profile, to determine whether the generated vibration profile for the test cycle of the cartridge deviates from the pre-established vibration profile, and, based on the comparison of the test cycle of the cartridge with the pre-established vibration profile, to indicate whether the analyzer is functioning properly. 
   
     
     
         16 . The method of  claim 15 , wherein the cartridge comprises a latch engaged by the analyzer when the cartridge is fully inserted and generating a signature vibration profile detectable by the analyzer. 
     
     
         17 . The method of  claim 16 , wherein the computing device is further configured to compare the signature vibration profile to a pre-established vibration profile and, based on the comparison, to determine whether the cartridge is fully engaged by the analyzer. 
     
     
         18 . The method of  claim 17 , further comprising, in an event when the signature vibration profile deviates from the pre-established vibration profile, performing one or more of the following actions: logging the event, sending a notification to an operator of the analyzer, or preventing reporting of result of the in vitro analytical test generated during the test cycle of the cartridge. 
     
     
         19 . The method of  claim 15 , wherein the pre-established vibration profile is a typical vibration profile for a similar cartridge. 
     
     
         20 . The method of  claim 15 , further comprising, in an event when the vibration profile for the test cycle of the cartridge deviates from the pre-established vibration profile, performing one or more of the following actions: indicated that preventive maintenance of the analyzer is required, logging the event, sending a notification to an operator of the analyzer, performing maintenance of the analyzer, or preventing reporting of result of the in vitro analytical test generated during the test cycle of the cartridge.