IEEE Std 1708a-2019 pdf download

IEEE Std 1708a-2019 pdf download.IEEE Standard for Wearable, Cuffless Blood Pressure Measuring Devices Amendment 1.
The manufacturer’s product documentation shall include a description of the device characteristics, measurement principle, technology, and intended use with a rationale identifying confounding factors or, if none were identified, a rationale of why no confounding factors were identified. Any confounding factors shall be stated in the instructions for use.
4.3.3 Special patient populations and confounding factors
If a wearable, cuffless BP measuring device’s intended use is not limited to the population described by the subject selection requirements in 4.3.1 or if additional confounding factors have been identified as in 4.3.2, performance evaluation (4.1, 4.2, 4.4, 4.5, and 4.6) shall be performed for that population with at least 85 subjects, see D.5.
Instructions for use shall state whether the device is intended or not intended for use in the presence of each confounding factor identified in 4.3.2. If the populations in item a) through item c) arc within the device’s intended use as determined by reviewing the instructions for use, then the corresponding testing for each population shall be carried out.
a) For devices intended for patients over 50 years of age: in addition to the study for patients 50 years and younger, with at least 20% of patients representing the upper age decade for which the device is intended (e.g., for devices intended for adults up to 100 years, a study shall be conducted in patients 21 to 50, and a separate study shall be conducted in patients 50 to 100, with at least 20% of the patients between 90 and 100 years of age).
b) For devices intended for any of the pediatric patient classes [pediatric-neonates (birth-28 days), pediatric-infants (29 days to 2 years), pediatric-children (2 to 12 years), pediatric-adolescents (12 to 20 years)]: All subjects should be aged between the class limits.
c) For devices intended for use in patients with arrhythmias, a separate study (phase I and 2) shall he conducted with patients having arrhythmias consistent with the device’s intended use, and patient age between 21 and 50.
d) For devices intended for use in patients undergoing vasoactive drug therapy, a separate study (phase 1 and 2) shall be conducted with patients using vasoactive drugs consistent with the device’s intended use, and patient age between 21 and 50. If vasoactive drug therapy within the intended use includes both vasodilator and vasoconstrictor drugs, at least 40% of patients should undergo vasoconstrictive drugs, and at least 40% should undergo vasodilator drugs.
c) For devices also intended for use in pregnant (including pre-eclamptic) patients, a separate study (phase 1 and 2) shall be conducted with female pregnant patients 21 years or older, after week 20 of pregnancy; 30% ± I of patients shall be ‘pre-ec1amptic” (i.e., with proteinuria > 300 mg in 24 h and diastolic blood pressure 90 mmHg).
Instructions for use shall state whether the device is intended or not intended for use in the presence of each confounding factor identified in 4.3.2. If confounding factors are within the device’s intended use as determined by reviewing the instructions for use, then a separate study (phase I and 2) shall be conducted for each additional confounding factor not included in list items a) to c).
The performance for each confounding factor and special patient population tested shall be listed in the instructions for use. Compliance is checked by reviewing the instructions for use, product documentation, and performance validation report.
Two test devices should be randomly chosen from the device pool. Those two devices should be used through the whole validation procedure with each device completing validation on at least 2 subjects.
Concerning the special feature of the cuffless BP measuring devices, where the calibration efficacy would greatly influence the device accuracy, the validation procedures are considerably different from that of the cuff-based devices. For each subject, the procedure is broken down into three levels: static test, test with BP change from the calibration point, and test after a certain period of time from calibration. Practitioners should properly design their validation protocol to cover the validation from each of the three levels.
4.4.2 Static test
Insert new text and figure after the last paragraph as follows (and renumber the rein aimider of the figures accordingly.):
During the static test, a subject shall maintain a proper posture. Shown in Figure 2 is the proper posture for the static test where the subject should sit on a chair comfortably, with their back straight and supported (a wristband form factor is used in this figure for illustration purposes only while various form factors exist for the cuffless blood pressure monitor). Feet shall be flat on the floor and legs shall not be crossed. Both arms shall be supported on a flat surface with the upper arms at the heart level.