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IEEE 1708a-2019 pdf free download
IEEE 1708a-2019 pdf free download.IEEE Standard for Wearable Cuffless Blood Pressure Measuring Devices Amendment 1.
6. Device function and performance during ambulatory conditions and patient motion
Patient motion can induce noise and artifacts into the recorded signals that may impact measurement accuracy of wearable, cuftiess blood pressure measurement devices. These devices may be intended to be used only when the patient is static and under non-motion conditions, or they may be intended to be used during ambulatory conditions and, more generally, in the presence of various types of patient activities. The manufacturer may design motion detection or signal quality assessment algorithms that automatically identify when the recorded signals have noise and artifacis to prevent degradation of accuracy during these conditions.
6.1 Robustness to motion induced noise
Tolerance of BP measurement performance in the presence of motion induced noise shall be evaluated. This may be performed by simulated testing that adds representative noise signals to device sensor signals or clinical testing. The performance shall be evaluated across a range of signal-noise ratios that includes normal- and worst-case recording conditions and signal quality. The description of the methods used shall include objective evidence to support that the noise signals and conditions tested are representative of the expected motion induced noise and a rationale for the worst-case conditions tested. The description of the methods and results shall be included in the instructions for use.
6.2 Device design in relation to ambulatory conditions and motion
The manufacturer shall specify the category of their wearable cuffless device according to Table 8 and include this information in the instructions for use. This considers whether the wearable cumess device is intended to provide measurements during ambulatory conditions and/or patient motion activities and whether the device includes any motion detection or signal quality assessment algorithms.
6.3 Performance during ambulatory and motion conditions
The manufacturer shall follow the appropriate list item a) through item d) depending on the category of
their device from Table 8:
a) The device is intended only to provide measurements when the patient is in a static position under non-motion conditions and does not include motion detection. It is the responsibility of the user to ensure the patient is under non-motion conditions during measurement periods.
— The instructions for use shall specify that the patient should remain still during measurement periods and that measurements made during ambulatory conditions and patient motion may be unreliable and the accuracy during these conditions has not been evaluated.
b) The device is intended to provide measurements during specified ambulatory conditions and/or patient motion activities. It is the responsibility of the user to ensure the patient activities during measurement periods arc not expected to induce signal noise or artifacts at levels greater than those specified.
1) The instructions for use shall specify the types of ambulatory conditions and patient motion activities under which the device has been tested for measurement performance. Conditions that may need to be specified depend on the intended use of the device, sensors used, and the anatomical placement of the sensors used as part of the wearable, cufTiess blood pressure measurement device. Example conditions that may require testing include the following:
i) Ambulatory conditions: walking, running. bike-riding, automobile transport, helicopter transport. etc.
ii) Patient motion activities: typing, hand rotations, arm waving, kicking. etc.
2) Testing shall demonstrate that the accuracy of blood pressure measurements during the specified ambulatory conditions and patient motion activities is acceptable.
3) The instructions for use shall disclose the HP measurement accuracy specification during the specified ambulatory conditions and patient motion activities and a summary of the test methods.IEEE 1708a-2019 pdf free download.
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