IEEE Std 1708a pdf free download
IEEE Std 1708a pdf free download.Wearable, Cuffless Blood Pressure Measuring Devices.
4.3 Subject selection
Inxert ,,ew 4.3.1 heading before text in 4.3 and change text as folio H’s:
4.3.1 Subject selection requirements for normal adult population
The summarized requirements on subject selection are presented in Table 1. Forty five At least eighty-five (85) subjects. with at least 2 26 females and 22 4226 males, aged between -l-Xj years and Q years old shall be recruited if the device is intended for adult use. The study participants are to be introduced to the observers, who will explain to them the eligibility requirements and specific procedures. Initials, sex, date of birth, medical history and current medications arc to be recorded on the case report form. Pregnant, pediatric, or elderly people, or those with present arrhythmias, should not be included in the study. jj wearable, cuffless BP measuring device’s intended use is not limited to the pqpulation described by the subject selection requirements in 4.3.1. additional performance evaluation shall be conducted according to 4.3.3. The intended use population is determined by reviewing the instructions for use.
The subjects shall also have a specified range of BP. The endpoint of the BP classification is determined according to the iNC 7 report [1351. The BP used in the analysis should be the entry BP measured by a trained observer following the recommendation called out by BHS protocol 1321. Three measurements are required at the sitting position, and the averaged value is used as the entry BP to determine the subject’s BP classi tication.
If a wearable, cuffless 13P measuring device uses patient-specific parameters (height, weight, sex, age, etc.) in the calculation of BP. each patient-specific parameter used in the calculation should be recorded in the case rert form. The range of each parameter from the study participants should cover the expected pulation dung device use. The device accuracy for patient-specific parameters should be presented in Table 6 where a row should be included for each patient-specific parameter used in the BP calculation.
4.3.3 Special patient populations and confounding factors
If a wearable, cutTless 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 2110 50, and a separate study shall be conducted in patients 50 to 100, with at least 20Yo 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 be conducted with patients having arrhythmias consistent with the device’s intended use, and patient age between 21 and 50.IEEE Std 1708a pdf download.
