SYSTEMS, METHODS AND APPARATUS FOR ACQUIRING AND MANAGING PATIENT/SUBJECT DATA
First Claim
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1. An ECG acquisition device comprising:
- a central processing unit;
an input interface connected to the central processing unit for acquiring subject biometric data;
a memory module connected to the central processing unit for storing the subject biometric data; and
a user interface connected to the central processing unit for initiating acquisition of the subject biometric data.
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Abstract
An ECG acquisition device including a central processing unit, an input interface connected to the central processing unit for acquiring subject biometric data, a memory module connected to the central processing unit for storing the subject biometric data and ECG data, and a user interface connected to the central processing unit for initiating acquisition of the subject biometric and ECG data. The ECG acquisition device is connected to a site PC for downloading and managing the ECG and biometric data, which is transmitted to a Clinical Information System by the site PC.
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Citations
30 Claims
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1. An ECG acquisition device comprising:
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a central processing unit; an input interface connected to the central processing unit for acquiring subject biometric data; a memory module connected to the central processing unit for storing the subject biometric data; and a user interface connected to the central processing unit for initiating acquisition of the subject biometric data. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. An ECG acquisition device comprising:
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a central processing unit; a USB interface connected to the central processing unit; an input interface connected to the central processing unit for acquiring subject biometric data; a memory module connected to the central processing unit for storing the subject biometric data; a user interface connected to the central processing unit for initiating acquisition of the subject biometric data; an ECG acquisition module for acquiring subject ECG data; and wherein the central processing unit includes programmed instructions to prevent acquisition of subject ECG data until the subject biometric data has been acquired and stored in the ECG acquisition device, check the quality of the ECG subject data, and prevent storage of the ECG subject data until the quality meets acceptability standards.
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13. A system for acquiring and storing data, the system comprising:
a computer connectable to an ECG acquisition device, the ECG acquisition device including inputs for acquiring subject biometric data and acquiring subject ECG data, the computer including programmed instructions for receiving the subject biometric data and subject ECG data, verifying the subject biometric data and subject ECG data, storing the verified data and deleting the subject biometric data and the subject ECG data from the ECG acquisition device after storing the data. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20)
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21. A system for acquiring and storing data, the system comprising:
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a computer connectable to an ECG acquisition device, the ECG acquisition device including inputs for acquiring subject biometric data and acquiring subject ECG data, programmed instructions to perform a preliminary noise assessment to the subject ECG data to evaluate the quality of the connection between the subject and the acquisition device, a lead off detection check, a baseline wander check, a muscle artifact check to detect error in the subject ECG data, and transmit ECG acquisition device identification information with the subject ECG data to a data record, the computer including programmed instructions for receiving the paired subject biometric data and subject ECG data, verifying the paired subject biometric data and subject ECG data, storing the verified data, deleting the subject biometric data and the subject ECG data from the ECG acquisition device after storing the data, generating an audit trail of changes and edits made to an electronic record of stored subject ECG data, generate an audit trail of activities related to the system including a log of system logins and logouts, generating a report including a date and time of an ECG acquisition and an acquisition device unique identifier and a plurality of software modules programmed to perform analysis on the subject ECG data, the independent software modules include but are not limited to a rhythm diagnostics module programmed to generate a report that provides a summary table with the frequency of normal and abnormal heartbeats, an interval analysis module capable to execute on a predetermined-time interval ECG reading, a diagnostic analysis module capable to generate a diagnosis for the subject ECG data that has been extracted and parsed, and a morphology module configured to take the subject ECG extractions that were previously measured and average the subject ECG extractions out with a subject ECG data reading measured according to morphology standards; and means for communicating with a remote clinical information system (CIS) and programmed instructions for contacting the CIS, uploading the data to the CIS and deleting the data from the computer from the computer when transfer of the data to the CIS has been confirmed.
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22. A method of acquiring and managing data acquired from a subject using a data acquisition device connectable to a specially programmed computer, the method comprising:
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acquiring biometric data from a subject and storing the biometric data on the acquisition device; acquiring ECG data from the subject and storing the ECG data on the acquisition device in association with the biometric data; connecting the acquisition device to the specially programmed computer; transferring the data to the specially programmed computer; and deleting the data from the acquisition device. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29)
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30. A method of acquiring and managing data acquired from a subject using a data acquisition device connectable to a specially programmed computer, the method comprising:
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acquiring biometric data from a subject and storing the biometric data on the acquisition device; performing a preliminary noise assessment to the subject ECG data to evaluate the quality of the connection between the subject and the acquisition device; performing a lead off detection check, baseline wander check, and muscle artifact check to detect error in the subject ECG data; acquiring ECG data from the subject, and storing the ECG data on the acquisition device in association with the biometric data; connecting the acquisition device to the specially programmed computer; transferring the data to the specially programmed computer; verifying the transfer between the acquisition device and the specifically programmed computer; deleting the data from the acquisition device; generating an audit trail of changes and edits made to an electronic record of stored subject ECG data and generating an audit trail of activities related to the system such as a track and log of system logins and logouts; transmitting the ECG acquisition device identification information with the subject ECG data to a data record; transmitting the data to a clinical information system; verifying the transfer; deleting the data from the specially programmed computer only when the transfer has been verified; and wherein further analysis of the ECG data is performed by programming modules, including a rhythm diagnostics module generating a report that provides a summary table with the frequency of normal and abnormal heartbeats, an interval analysis module executing being executed on a predetermined-time interval ECG reading, a diagnostic analysis module generating a diagnosis for the subject ECG data that has been extracted and parsed; and
a morphology module taking the subject ECG extractions that were previously measured and averaging the subject ECG extractions out with a subject ECG data reading measured according to morphology standards.
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Specification