IEEE 1708a-2019

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IEEE Standard for Wearable, Cuffless Blood Pressure Measuring Devices – Amendment 1

Published By	Publication Date	Number of Pages
IEEE	2019

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Category: IEEE

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Description

Amendment Standard – Active. Clarifying and furthering the subject selection of the sample size in the clinical study; looking into the results of the validation study with respect to the patient’s body position and activity level for their applicability to ambulatory patients; and addressing the issues of motion artifact is covered in the amendment.

PDF Catalog

PDF Pages	PDF Title
1	IEEE Std 1708a™-2019 Front cover
2	Title page
4	Important Notices and Disclaimers Concerning IEEE Standards Documents
7	Participants
8	Introduction
9	Contents
10	4. Performance evaluation 4.1 Summary
11	4.2 Observer training and measurement 4.2.2 Observer measurement
12	4.3 Subject selection 4.3.1 Subject selection requirements for normal adult population 4.3.2 Confounding factors
13	4.3.3 Special patient populations and confounding factors
14	4.4 Validation procedure 4.4.1 Introduction 4.4.2 Static test
15	4.5 Validation criteria 4.5.1 Introduction
16	4.5.3 Phase 2 4.5.3.2 Accuracy at different BP change levels
17	4.6 Data reporting 4.6.1 Subject information 4.6.2 Statistical report
20	4.6.3 Graphic representation 6. Device function and performance during ambulatory conditions and patient motion 6.1 Robustness to motion induced noise 6.2 Device design in relation to ambulatory conditions and motion
21	6.3 Performance during ambulatory and motion conditions
24	Annex C (informative) Posture of subject during validation test
25	Annex D (informative) Justification of sample size D.1 Introduction
26	D.2 Experimental findings of estimation errors in cuffless BP measuring devices
27	D.3 Sample size determination based on MAD
30	D.4 Effect of repeated measurements from subjects
31	D.5 Confounding factors and special patient conditions
33	Annex E (informative) Bibliography
35	Back cover