Referências
References
Bibliografia, normas regulatórias aplicáveis, datasets públicos utilizados para calibração estatística e ferramentas de software de referência.
Bibliography, applicable regulatory standards, public datasets used for statistical calibration, and reference software tools.
Modelagem bioelétrica
Bioelectrical modeling
- Cole, K. S.; Cole, R. H. Dispersion and absorption in dielectrics I. Alternating current characteristics. J. Chem. Phys. 9, 341 (1941). → Modelo Cole-Cole; base dos módulos 01-02.
- Schwan, H. P. Electrical properties of tissue and cell suspensions. Adv. Biol. Med. Phys. 5, 147–209 (1957). → Dispersões α, β, γ; justificativa para fc no MHz.
- Kyle, U. G. et al. Bioelectrical impedance analysis – part I: review of principles and methods. Clin. Nutr. 23, 1226–1243 (2004). → Configuração tetrapolar; protocolo padrão.
- Bera, T. K. Bioelectrical impedance methods for noninvasive health monitoring: a review. J. Med. Eng. 2014, 381251 (2014). → Survey de configurações 4/8/12 eletrodos.
ICG e plethismografia
ICG and plethysmography
- Kubicek, W. G. et al. Development and evaluation of an impedance cardiac output system. Aerosp. Med. 37, 1208–1212 (1966). → Kubicek ICG; base do módulo 04.
- Sramek, B. B. Noninvasive technique for measurement of cardiac output by means of electrical impedance. Proc. 5th ICEBI, 39–42 (1981).
- Bernstein, D. P. Continuous noninvasive real-time monitoring of stroke volume and cardiac output by thoracic electrical bioimpedance. Crit. Care Med. 14, 898–901 (1986).
- Charlton, P. H. et al. Breathing rate estimation from the electrocardiogram and photoplethysmogram: a review. IEEE Rev. Biomed. Eng. 11, 2–20 (2018). → Algoritmos de extração de FR.
Gasto energético e fusão
Energy expenditure and fusion
- Keytel, L. R. et al. Prediction of energy expenditure from heart rate monitoring during submaximal exercise. J. Sports Sci. 23, 289–297 (2005). → Equação Keytel; módulo 03.
- Brage, S. et al. Branched equation modeling of simultaneous accelerometry and heart rate monitoring improves estimate of directly measured physical activity energy expenditure. J. Appl. Physiol. 96, 343–351 (2004).
- Plasqui, G.; Westerterp, K. R. Physical activity assessment with accelerometers: an evaluation against doubly labeled water. Obesity 15, 2371–2379 (2007).
- Schmidt, P. et al. Introducing WESAD, a multimodal dataset for wearable stress and affect detection. Proc. 20th ACM ICMI, 400–408 (2018). → Dataset WESAD; calibração do módulo 06.
Processamento digital de sinais
Digital signal processing
- Oppenheim, A. V.; Schafer, R. W. Discrete-Time Signal Processing. 3ª ed., Pearson (2009). → Filtros IIR; ponto-fixo.
- Pan, J.; Tompkins, W. J. A real-time QRS detection algorithm. IEEE Trans. Biomed. Eng. BME-32, 230–236 (1985). → Detector de picos; arquitetura do módulo 05.
- Smith, S. W. The Scientist and Engineer's Guide to Digital Signal Processing. California Technical Pub (1997). → Referência aberta · dspguide.com.
Normas regulatórias
Regulatory standards
- IEC 62304:2006/AMD1:2015 · Medical device software — Software life cycle processes. → Classe B aplicável.
- IEC 60601-1:2005/AMD2:2020 · Medical electrical equipment — Part 1: General requirements for basic safety and essential performance.
- IEC 60601-2-49:2011 · Particular requirements for multifunction patient monitoring equipment.
- ISO 14971:2019 · Medical devices — Application of risk management.
- ANVISA RDC 657/2022 · Registro e notificação de dispositivos médicos.
- FDA 21 CFR 870.2700 e 21 CFR 870.2840 · Oximeter; impedance plethysmograph. → Precedente 510(k).
- HL7 FHIR R5 · Fast Healthcare Interoperability Resources. → Integração SUS Digital.
Datasets públicos
Public datasets
- MIMIC-III Waveform Database · Goldberger, A. L. et al. PhysioBank, PhysioToolkit, and PhysioNet. Circulation 101, e215–e220 (2000). → physionet.org/content/mimic3wdb/
- WESAD · Wearable Stress and Affect Detection. → PPG + accel + respiração.
- PPG-DaLiA · Reiss, A. et al. Deep PPG: large-scale heart rate estimation with convolutional neural networks. Sensors 19, 3079 (2019).
- PAMAP2 · Reiss, A.; Stricker, D. Introducing a new benchmarked dataset for activity monitoring. 16th ISWC, 108–109 (2012).
Aviso de uso · Os datasets foram referenciados estatisticamente (médias, desvios, amplitudes de artefatos) para parametrizar os geradores sintéticos do módulo 06. Nenhum dado real foi embutido. Uso direto em TRL 4 requer credenciais PhysioNet (CITI training) e aceitação dos termos.
Usage notice · Datasets were referenced statistically (means, deviations, artifact amplitudes) to parameterize the module 06 synthetic generators. No real data was embedded. Direct use at TRL 4 requires PhysioNet credentials (CITI training) and acceptance of terms.
Ferramentas de referência
Reference tools
- NeuroKit2 · Makowski, D. et al. NeuroKit2: A Python toolbox for neurophysiological signal processing. Behavior Research Methods 53, 1689–1696 (2021).
- WFDB Python · github.com/MIT-LCP/wfdb-python. → Loader PhysioNet · TRL 4.
- SciPy Signal · Virtanen, P. et al. SciPy 1.0: fundamental algorithms for scientific computing in Python. Nat. Methods 17, 261–272 (2020).