ANSI/AAMI EC AAMI Association for the. Advancement of Medical. Instrumentation. Cardiac monitors, heart rate meters, and alarms. LabVIEW is used to generate ECG signals that satisfy the waveform requirements for ANSI/AAMI EC13 and NI Requirements Gateway helps. ANSI/AAMI EC13 Test Waveforms 3a and 3b, as obtained from the PhysioBank database.
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The EC13 standard establishes minimum safety and performance requirements for electrocardiograph ECG heart rate and waveform monitors that are intended for use under the operating conditions specified in this standard.
The US FDA Guidance Documents web site offers information to assist in the preparation of premarket notification k applications for devices regulated under: As noted in the FDA guidelines, to show substantial equivalence and conformance to the EC13 standard, a manufacturer should list each of the requirements of the standard and describe how the device conforms to each requirement. For every requirement, test data and analysis documentation should be provided and clearly identified.
Medical device corporations often exert many hours manually documenting test methods and results to the EC13 guidelines. Automating requirement traceability and documentation reporting. Learn more about NI Requirements Gateway.
You will need to have the following applications in evaluation or full license form installed on your computer to use the example attachments:.
Cardiac Monitor Test (ECG) under ANSI/AAMI EC13 with LabVIEW – National Instruments
NI Requirements Gateway traceability documentation is included for explicit traceability of information documents required by the EC13 standard. These imported documents include test requirements, test methods and test results.
The NI Requirements Gateway tool helps set up a standard and efficient verification process to reduce manual processes and increase quality. Click the Browse button and navigate to aam database file to retrieve the ECG segments in the file.
Open this VI and examine the block diagram for more information. Attenuation circuit for analog signal generation to ECG devices. The red arrow indicates the analog output in magnitude of volt, while the green arrow indicates the attenuated signal in magnitude of millivolt.
The magnitude of the analog signal has been attenuated by The NI Requirements Gateway improves the management of documents by linking traceability information from a wide range of sources. You trace Requirements and Test Methods in your documents with specific grammar searching templates, which are defined by aamo or customized Regular Expressions.
After you import documents, Requirements Wc13 identifies the information in these documents via the regular expressions and performs automated analysis. You must create your test documents before using the NI Requirements Gateway. Refer to the documentation on the NI Requirements Gateway for more information on how to create documents with built-in or customized regular expressions.
ANSI/AAMI EC13 Test Waveforms
In the Figure 3, five documents are imported into the example project awmi are divided into three layers. The top layer contains all test requirements, the intermediate layer includes the test methods and test results, and the bottom layer includes detailed implementation of the test methods. The arrows highlighted by red circles imply the traceability information.
The NI Requirements Gateway can extract information from any document that you add to this application and generate the final test report. You can customize the template of the report to obtain information you need. Aamo following figure shows an example report that lists test names, requirements, results, and traceability information. This example also aaami an overall description of the test, providing information such as coverage ratio, number of passed tests, and number of failed tests.
Refer to the documentation of NI Requirements Gateway for detailed information about managing your tests and generating test reports. A portion of all the tests are completed in the provided examples. You can add to each example and document template to create a complete set of materials. Rate this document Select a Rating 1 – Poor 2 3 4 5 – Excellent.
Cardiac Monitor Test (ECG) under ANSI/AAMI EC13 with LabVIEW
The sampling rate of the analog signal must be the same as that of the digital signal. The resulting analog signal is in magnitude of volts, but you usually want them in magnitude of millivolts. You aamo attenuate the voltage. The following figure shows an example of attenuation circuit from eec13 AAMI standard: Attenuation circuit for analog signal generation to ECG devices The red arrow indicates the analog output in magnitude of aaim, while the green arrow indicates the attenuated signal in magnitude of millivolt.
Back to Top 3. Artifact Traceability and Document Management as part of EC13 The NI Requirements Gateway improves the management of documents by linking traceability information from a wide range of sources. You can find the full requirement list in the official document for this standard. You can find the full list of test methods in the amai document for this standard. Back to Top 4. In the Configuration dialog box, you can add all test documents into the project and organize them properly.
The following screen shot shows how the example project in the attachment organizes the test documents: NI Requirements Gateway project window In the Figure 3, five documents are imported into the example project and are divided into three layers. After you add the documents, click the OK button to close the Configuration dialog box. This example also includes an overall description of the test, providing information such as coverage ratio, number of passed tests, and number of failed tests Figure 4.
NI Requirements Gateway test report Refer to the documentation of NI Requirements Gateway for detailed information about managing your tests and generating test reports. Back to Top 5. Greg Crouch, National Instruments.