IEEE 11073-10429-2022

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IEEE Standard for Health Informatics — Device Interoperability — Part 10429: Personal Health Device Communication — Device Specialization – Spirometry (Approved Draft)

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IEEE	2022	134

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Description

New IEEE Standard – Active. Within the context of the ISO/IEEE 11073 family of standards for device communication, in this standard, a normative definition of the communication between personal telehealth spirometry devices and managers (e.g., cell phones, personal computers, personal health appliances, set-top boxes) is established in a manner that enables plug-and-play interoperability. Appropriate portions of existing standards are leveraged, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors are specified in telehealth environments restricting optionality in base frameworks in favor of interoperability. A common core of communication functionality for personal telehealth spirometry is defined in this standard.

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PDF Pages	PDF Title
2	IEEE Std 11073‐10429™‐2022 Front cover
4	Important Notices and Disclaimers Concerning IEEE Standards Documents
8	Participants
11	Introduction
12	Contents
14	1. Overview 1.1 Scope 1.2 Purpose 1.3 Word usage
15	1.4 Context 2. Normative references
16	3. Definitions, acronyms, and abbreviations 3.1 Definitions
17	3.2 Acronyms and abbreviations
18	4. Introduction to ISO/IEEE 11073 personal health devices 4.1 General 4.2 Introduction to IEEE 11073-20601 modeling constructs 4.2.1 General 4.2.2 Domain information model
19	4.2.3 Service model 4.2.4 Communication model 4.2.5 Implementing the models 4.3 Compliance with other standards
20	5. Spirometry device concepts and modalities 5.1 General
21	5.2 Spirometry tests 5.3 Home spirometry measures
22	5.3.1 Forced expiratory volume in 1 s (FEV1) 5.3.2 Peak expiratory flow (PEF)
23	5.4 Common spirometry measures 5.4.1 Forced vital capacity
24	5.4.2 Slow vital capacity (SVC) 5.4.3 Forced expiratory volume in six seconds (FEV6) 5.5 Spirometry measures used for children 5.5.1 Forced expiratory volume in 0.5 s (FEV0.5) 5.5.2 Forced expiratory volume in 0.75 s (FEV0.75). 5.6 Spirometry measures normalized to FVC, SVC, and FEV6 5.6.1 Ratio of forced expiratory volume in 1 s/FVC (FEV1/FVC) 5.6.2 Ratio of forced expiratory volume in 1 s/SVC (FEV1/SVC)
25	5.6.3 Ratio of Forced Expiratory Volumes in 1 s and 6 s (FEV1/FEV6) 5.6.4 Ratio of forced expiratory volume in 0.5 s/FVC (FEV0.5/FVC) 5.6.5 Ratio of forced expiratory volume in 0.75 s/FVC (FEV0.75/FVC) 5.7 Spirometry measures related to forced expiratory flow 5.7.1 Forced expiratory flow at 25 % of FVC (FEF25) 5.7.2 Forced expiratory flow at 50 % of FVC (FEF50) 5.7.3 Forced expiratory flow at 75 % of FVC (FEF75) 5.7.4 Forced expiratory flow between 25 % and 75 % of FVC (FEF25–75)
26	5.8 Spirometry measures related to forced inspiration 5.8.1 Forced inspiratory vital capacity (FIVC) 5.8.2 Forced inspiratory volume in 1 s (FIV1) 5.8.3 Forced inspiratory flow at 25 % of FIVC (FIF25) 5.8.4 Forced inspiratory flow at 50 % of FIVC (FIF50) 5.8.5 Forced inspiratory flow at 75 % of FIVC (FIF75) 5.8.6 Peak inspiratory flow (PIF) 5.9 Spirometry measures related to volume during unforced breathing 5.9.1 Tidal volume (TV)
27	5.9.2 Inspiratory capacity measured from tidal volume (IC) 5.9.3 Expiratory reserve volume (ERV) 5.9.4 Inspiratory reserve volume (IRV) 5.9.5 Inspiratory vital capacity measured from maximal exhalation (IVC) 5.10 Spirometry measures related to BTPS correction, calibration verification/check, and technical factors 5.10.1 Body temperature-pressure-saturated (BTPS) correction factor 5.10.2 Ambient air pressure 5.10.3 Ambient room temperature 5.10.4 Patient-immediate ambient relative humidity
28	5.10.5 Date/Time of last calibration verification/check session 5.10.6 Last calibration verification/check session, number of calibration verifications 5.10.7 Last calibration verification/check session, volumes measured 5.10.8 Last calibration verification/check session, number of failed calibration verifications 5.10.9 History of calibration verification/check sessions 5.10.10 Testing position 5.10.11 Nose clips 5.10.12 Bronchodilator 5.11 Spirometry measures related to test quality assessment 5.11.1 Forced expiratory time (FET) 5.11.2 Back-extrapolated volume (BEV, EVOL, Vext)
29	5.11.3 Achievement of end of forced expiration (EOFE) 5.11.4 FIVC-FVC 5.11.5 Point at which expiratory flow ceases 5.11.6 Individual FVC maneuver acceptability 5.11.7 Number of acceptable FVC maneuvers 5.11.8 Between-maneuver FVC reproducibility 5.11.9 Between-maneuver FEV1 reproducibility
30	5.11.10 FVC quality grade 5.11.11 FEV1 quality grade 5.12 Spirometry waveform measures 5.12.1 Volume-time waveform (VT)
31	5.12.2 Flow-time waveform (FT) 5.13 Interpretive spirometry measures 5.13.1 Reference equations 5.13.1.1 Assigned sex at birth 5.13.1.2 Gender Identity 5.13.1.3 Age 5.13.1.4 Height 5.13.1.5 Weight 5.13.1.6 Body mass index
32	5.13.1.7 GLI-2012 racial/ethnic group 5.13.1.8 NHANES-III racial/ethnic group 5.13.2 LLN FEV1 5.13.3 LLN FVC 5.13.4 LLN FEV6 5.13.5 LLN SVC 5.13.6 LLN FEV0.5 5.13.7 LLN FEV0.75 5.13.8 LLN FEV1/FVC 5.13.9 LLN FEV1/FEV6
33	5.13.10 LLN FEV1/SVC 5.13.11 Z-score FEV1 5.13.12 Z-score FVC 5.13.13 Z-score FEV6 5.13.14 Z-score SVC 5.13.15 Z-score FEV0.5 5.13.16 Z-score FEV0.75 5.13.17 Z-score FEV1/FVC
34	5.13.18 Z-score FEV1/FEV6 5.13.19 Z-Score FEV1/SVC 5.13.20 Percent predicted FEV1 5.13.21 Percent predicted FVC 5.13.22 Percent predicted FEV6 5.13.23 Percent predicted SVC 5.13.24 Percent predicted FEV0.5 5.13.25 Percent predicted FEV0.75
35	5.14 Graphical representation of some spirometry measures 5.14.1 Spirometry volumes 5.14.2 Spirometry volume-time curve
36	5.14.3 Prediction equations and Z-score 5.14.4 Back extrapolated volume (BEV)
37	6. Spirometer domain information model 6.1 Overview 6.2 Class extensions 6.3 Object instance hierarchy
39	6.4 Types of configuration 6.4.1 General 6.4.2 Standard configuration 6.4.3 Extended configuration
40	6.4.4 Spirometry sessions
41	6.4.4.1 Observation-Id and Observation-Ref-List attributes 6.4.4.2 Measurement references
43	6.4.4.3 Measurement time stamping 6.4.4.4 Measurement quality analyses
44	6.4.4.5 Spirometry agent workflows and measurement delivery 6.4.4.6 Spirometry measurements 6.4.4.7 Behavior on incomplete sessions
78	7. Spirometer service model 7.1 General 7.2 Object access services
80	7.3 Object access event report services 8. Spirometer communication model 8.1 Overview 8.2 Communications characteristics 8.3 Association procedure 8.3.1 General 8.3.2 Agent procedure—association request
82	9. Operating procedure 9.1 General 9.2 GET Spirometer MDS attributes 9.3 Measurement data transmission 9.4 Time synchronization
83	10. Test associations 11. Conformance 11.1 Applicability 11.2 Conformance specification 11.3 Levels of conformance 11.3.1 General 11.3.2 Conformance level 1: Base conformance
84	11.3.3 Conformance level 2: Extended nomenclature (ASN.1 and/or ISO/IEEE Std 11073-10101) 11.4 Implementation conformance statements 11.4.1 General format 11.4.2 General implementation conformance statement
86	11.4.3 DIM MOC implementation conformance statement 11.4.4 MOC attribute ICS
87	11.4.5 MOC notification implementation conformance statement 11.4.6 MOC nomenclature conformance statement
88	Annex A (informative) Bibliography
90	Annex B (normative) Any additional ASN.1 definitions B.1 Observation-Id data type B.2 Observation-Ref-List data type
91	Annex C (normative) Systematic names for nomenclature C.1 Nomenclature, data dictionary, and codes for spirometry C.1.1 Introduction C.1.2 Base concepts C.1.3 First set of differentiating criteria C.1.3.1 Semantic link “type:” C.1.3.2 Semantic link “has direction:” C.1.3.3 Semantic link “of form”
92	C.1.4 Second set of differentiating criteria C.1.4.1 Semantic link “concerns:” C.1.5 Third set of differentiating criteria C.1.5.1 Semantic link “procedure used:” C.1.6 Code table
101	Annex D (normative) Allocation of identifiers
106	Annex E (informative) Message sequence examples
108	Annex F (informative) Protocol data unit examples F.1 General
109	F.2 Association information exchange F.2.1 General F.2.2 Extended configuration F.2.2.1 General F.2.2.2 Association request
110	F.2.2.3 Association response F.2.3 Previously known extended configuration F.2.3.1 General F.2.3.2 Association request
111	F.2.3.3 Association response F.3 Configuration information exchange F.3.1 General F.3.2 Extended configuration F.3.2.1 General F.3.2.2 Remote operation invoke event report configuration
120	F.3.2.3 Remote operation response event report configuration
121	F.3.3 Known configuration F.4 GET MDS attributes service F.4.1.1 General F.4.1.2 Get all medical device system attributes request F.4.1.3 Get response with all MDS attributes
123	F.5 Data reporting
124	F.5.1 Session Start
125	F.5.2 Response to confirmed measurement data transmission F.5.3 Settings
127	F.5.4 Examining the Time Stamps F.5.5 Maneuver Subsession Start
128	F.5.6 The RTSA Transmissions F.5.7 Maneuver Summary Measurements
130	F.5.8 Maneuver Subsession Stop
131	F.5.9 Second Maneuver Subsession F.5.10 Session Summary Measurements and Session Stop Indicator
133	F.6 Disassociation F.6.1 Association release request F.6.2 Association release response

Additional information

Standard Title	IEEE Standard for Health Informatics — Device Interoperability — Part 10429: Personal Health Device Communication — Device Specialization – Spirometry (Approved Draft)
Published Code	IEEE
Publication Date	2022
Pages Count	134

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