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Summary of Contents for StethoMe AI
- Page 1 INSTRUCTION FOR USE StethoMe AI Artificial Intelligence Algorithms ver.1_2021.10.05...
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Page 2: Scope Of Application
1. INTRODUCTION 1.1. About the Manual This instruction for use (IFU) is part of a medical device, i.e., the StethoMe AI artificial intelligence algorithms, hereinafter referred to as StethoMe AI. StethoMe Sp. z o.o. bears no liability and provides no guarantee with regard to damage (including indirect damage) arising due to lack of compliance with this user manual. -
Page 3: Precautions And Warnings
Severity of phenomena is presented on a scale from 0 to 100. StethoMe AI is also intended for determining the pulse rate (heart beats per minute, BPM), respiratory rate (breaths per minute, RR) and the inspiration/expiration ratio (i/e). - Page 4 The complete StethoMe manual is delivered with the StethoMe product. You can also ● find it at www.stethome.com. StethoMe AI should be used in accordance with the user manual. If you notice any ● abnormalities in the operation of StethoMe AI, please contact the manufacturer;...
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Page 5: Additional Information
2.6 Additional Information For more information visit www.stethome.com. 2.7. Medical Device Classification The StethoMe AI medical device has been classified according to Annex IX to Council Directive 93/42/EEC as class IIa, and is subject to rule 10. 2.8. Markings Manufacturer... - Page 6 StethoMe AI algorithms and then the results of this analysis are obtained (depending on transmission speed this will take just a few to several seconds). The results are recorded in the cloud, and can be accessed through a history of examinations in the application;...
- Page 7 Fig.1 After the analysis, the result is presented graphically using graphic templates. Symbols used in the results of the analysis of recorded auscultation sounds with StethoMe AI: Asthma control, examination status: - no abnormal auscultation sounds have been detected; ●...
- Page 8 The ‘Asthma control’ mode is particularly intended for patients diagnosed with ● bronchial asthma or with suspicion of asthma; The device detects symptoms such as abnormal auscultation sounds that occur in ● the course of asthma and other respiratory tract diseases; When the patient has symptoms of dyspnoea, shortness of breath, a strong cough, ●...
- Page 9 Dodatkowe parametry: respiratory rate value; ● pulse rate value; The recording and its detailed analysis are available in the application by clicking the ‘Detailed Test Result’ button. Instructions on how to read the result are available in the application by clicking the ‘Help’ button in the upper right corner of the screen.
- Page 10 Table 1. Example view of auscultation point analysis result templates* Minor intensity of all the abnormal auscultation sounds Major intensity of all the abnormal auscultation sounds - Major intensity of wheezes - Major intensity of rhonchi - Minor intensity of fine crackles - No coarse crackles - No wheezes - Major intensity of rhonchi...
- Page 11 4. ACTIVITIES DURING OPERATION OF STETHOME AI 4.1 Using StethoMe AI The description of how to use StethoMe AI is included in the user manual of the supported application or in the technical documentation provided with the software. In order to use StethoMe AI, a smartphone is required with an installed, authorized application, ●...
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