StethoMe AI Manuel utilisateur

INSTRUCTION FOR USE

StethoMe AI

Artificial Intelligence Algorithms

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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.

●Prior to using the medical device, you should read this user manual carefully.

●This user manual should be kept in a safe place for the entire lifecycle of the medical device.

●This user manual should be provided to every subsequent owner or user of the medical device.

●This user manual should be updated on the basis of every supplement received from the device

manufacturer.

The aim of this instruction is to describe a medical device – the StethoMe AI artificial intelligence

algorithms – taking account of the following in particular:

●Description of the medical device

●Safety of use

●Troubleshooting

●Maintenance service

Before commencing the examination, it is necessary to thoroughly read the medical device’s

(stethoscope) IFU supplied with the product and the instructions for the StethoMe AI product available at

www.stethome.com.

1.2. Scope of Application

The instruction for use applies to the most recent version of StethoMe AI artificial intelligence algorithms

(version available in the application).

1.3. Symbols and Marks Used in the Instruction for Use

Warnings and safety measures that must be followed in order to avoid

personal injury!

Warnings and safety measures that must be followed in order to avoid

damage to property!

Tips/additional information.

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2. CHARACTERISTICS

2.1. Intended Use of the Medical Device

StethoMe AI is a medical device that detects abnormal additional respiratory system sounds (wheezes,

coarse crackles, fine crackles, and rhonchi) in recordings originating from supported certified electronic

stethoscopes. StethoMe AI determines the pulse rate, as well as respiratory rate, and the

inspiration/expiration ratio in recordings originating from supported certified electronic stethoscopes.

The device may be used for analysing wheezes and rhonchi, respiratory rate, pulse rate, and the

inspiration/expiration ratio in the course of asthma.

This medical device is intended for users with a medical education background, as well as those without.

Any other application of the medical device is considered to be inconsistent with the intended

use and must be exclude

2.2. Recommendations for Using StethoMe AI

StethoMe AI is intended for detecting auscultatory changes in lungs, including asthma patients, and

determining classes of pathological phenomena. The following classes of pathological phenomena are

detected: wheezes, fine crackles, coarse crackles, and rhonchi. 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).

Based on detected additional abnormal auscultatory sounds, it is possible to present reliable

demonstrative information about the algorithm's response for the entire visit and alert the StethoMe AI

user if any significant auscultatory changes in lungs are detected. In addition the system informs about

exceeding the standard values in case of respiratory rate and pulse rate measurement.

2.3. Contraindications

Although StethoMe AI is equipped with a module for analysing recording quality and content of

interference, it should be remembered that in order for the analysis to work correctly, it is necessary to

exclude recordings of poor quality that include interference such as crying, conversation, coughing,

ambient noise, etc.

Due to the high physiologic variability of measured parameters, results for children under 1

year may be unreliable and the device is not recommended for use in this age group.

2.4 Potential Adverse Effects and Safety of the Medical Device

This medical device is completely safe for humans, provided that it is used in accordance with the user

manual.

2.5 Precautions and Warnings

●The StethoMe AI medical device is not intended for diagnostics in emergency

conditions! Remember that if you suspect any hazard to your patient’s life or health

(e.g., acute breathing disorders, impaired consciousness, loss of consciousness, cardiac

arrest, suspicion of acute coronary syndrome, panic attack, or trauma) it is forbidden to

either recommend them to use the StethoMe AI medical device or wait for the results of

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analysis performed by the StethoMe AI medical device. In the said situation, the patient

should urgently consult a physician or report the problem to the emergency number;

●No analysis carried out by the medical device – including in particular the cases where

the result of the analysis performed by the medical device is the non-identification of

abnormal additional sounds in the respiratory system or non-detection of heart

murmurs or pulse rate – should delay or substitute seeking medical attention by the

patient or reporting the problem by calling to the emergency number;

●The use of StethoMe AI medical device should never substitute a consulting physician

and only constitutes a supplement to the care provided by a physician. The results

obtained should never delay or substitute seeking medical attention. The process of

diagnostics and treatment, including using the StethoMe AI medical device, should be

supervised by medical personnel;

●StethoMe AI is intended for users with a medical education background and also those

without, however, using it is not a substitute for consulting a physician;

●NEVER diagnose a patient on your own based exclusively on the results obtained with

the device;

●ONLY your physician may prescribe treatment and diagnose respiratory diseases;

●Consult your physician with the results obtained from the device;

●The established respiratory rate (RR) and pulse rate (BPM) values are compared with

the ranges indicated in medical literature. On this basis, the results of the examination

are checked to see whether they are within the norm. It should be kept in mind that the

limit values for these parameters for individuals may differ from the ranges specified in

the literature and may be considered, by a doctor, to be physiologically correct, even

though the device may indicate that the accepted normative range is exceeded;

●Each time you are in doubt with the result, repeat the test, remembering to clear your

airways, blow your nose, and keep the room quiet during the examination;

●Please remember that the medications used or the disease itself may accelerate the

patient’s pulse rate or alter breathing;

●You can find the symbols used in the examination result in the Quick Start guide

provided with the StethoMe product;

●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;

●StethoMe AI supports only the recordings coming from the StethoMe electronic

stethoscope;

●NOTE: Do not modify files in a manner that changes the acoustic properties of the

signal recorded (e.g., reduction in sampling frequency, decrease in resolution, addition

of other signals, filtration, etc.). It is not recommended to use files originating from

other devices – the analysis of such files may turn out unsuccessful.

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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

Please read the user manual carefully before using

the device

2274

The medical device was issued a CE certificate and

compliant with European market guidelines

CAUTION! NOTE!

Please read the manual

2.9. Compliance with Standards

The medical device meets the requirements of IEC 62304 International Standard.

3. MEDICAL DEVICE FUNCTIONING

3.1. Technical Parameters

●The medical device is constituted by software available via WebAPI with the use of REST

protocol, described in the technical documentation available to integrators or through

supported applications;

●The WebAPI address where the service is available is provided together with the

software license;

●StethoMe AI uses neural network architecture.

3.2 Sound Analysis Algorithms

The medical device enables analysis of sounds from supported certified electronic stethoscopes in two

cases:

●analysis of respiratory system sounds - wheezes, fine crackles, coarse crackles, and rhonchi;

●analysis of heart sounds – determination of the pulse rate (BPM)

The following sections describe the forms of presenting the results.

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3.3 Patient Auscultation Mode Using the Application Connected to the StethoMe

Medical Device

To commence examination, you require an active StethoMe licence in the application, which you

purchased with the device. If you have not yet activated the licence, find the message with instructions

for licence activation in your email inbox and proceed in accordance with the instructions.

Launch the application and follow the instructions in the application.

Available test modes:

●Asthma control

Quick examination performed in one location. You can use it to measure the respiratory rate,

inspiration/expiration ratio, pulse rate and the intensity of rhonchi and wheezes.

●Complete lung examination

The examination is performed on 6-8 locations on the chest (depending on the patient’s age). Detects

abnormal auscultation sounds: wheezes, rhonchi, fine and coarse crackles. The respiratory rate is also

measured.

1. Select the mode in which you want to start the examination in the application;

2. Performing the recording involves applying the stethoscope’s membrane (Fig.1) to the patient’s

body at the points indicated in the application/on the stethoscope screen and holding the

stethoscope at a point until a progress bar is filled. The recording starts and ends automatically;

IMPORTANT! After placing the stethoscope on the body, the stethoscope automatically

commences recording.

3. In the case of a complete lung examination, selection of the auscultation point may be also

performed in the application by selecting a point other than the proposed one, as well as by

vigorously moving the stethoscope to the right or left;

4. It is recommended to record all the points indicated in the application/on the stethoscope screen;

5. If the application indicates points which require correction, repeat the recording at these points;

6. After all points are correctly recorded or the examination is forced to end with a smaller number

of recorded points, the recorded auscultation sounds are automatically transmitted for analysis by

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;

7. Once the examination ends, a short survey appears concerning the patient’s condition. The

results of the survey will be attached to the test results and recorded in the patient’s history;

8. The survey and the test results along with the sounds can be made available to a doctor by

sending a link for examination.

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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;

●- a small number of abnormal auscultation sounds have been detected;

●- abnormal auscultation sounds detected;

●- test result cannot be determined.

●wheezes intensity scale from 0 to 100;

●rhonchi intensity scale from 0 to 100;

●respiratory rate value;

●pulse rate value;

●inspiration/expiration duration ratio.

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●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,

obstruction may be so strong that pathological sounds may not be present. First,

administer the interventional medication prescribed by the doctor and consult the

doctor. In this case, you should always follow the doctor's instructions, regardless of

the result indicated by the device;

●DO NOT use in the event of an acute asthma attack or respiratory failure;

●It should be remembered that medication used in the treatment of asthma may

cause an accelerated pulse rate;

●The established respiratory rate (RR) and pulse rate (BPM) values are compared to

ranges indicated in medical literature. On this basis, the results of the examination

are checked as to whether they are within the norm. Down arrow is displayed for a

lower value and an up arrow for a higher value.

Complete lung examination, examination status:

●- no abnormal auscultation sounds have been detected;

●- a small number of abnormal auscultation sounds have been detected;

●- abnormal auscultation sounds detected;

●- test result cannot be determined.

●parameter value too high (BPM, RR)

●parameter value above normal (BPM, RR)

●parameter value below normal (BPM, RR)

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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.

Sections 3.4 and 3.5 are dedicated to the professional user

3.4 Detailed Analysis Results for a Single Auscultation Point

The template with detailed results presents extended information on the analysis of a single recording

from a visit. The view includes, among others:

1. The heart rate (pulse) expressed in beats per minute (BPM) or a “-” mark when the recording

quality makes it impossible to determine the BPM;

2. Respiratory rate (RR);

3. Inspiration/expiration ratio (i/e);

4. A spectrogram of the recording analysed;

5. Possibility to play back the sound recorded;

6. A detailed description of the recording with indication of the following in time:

a. the recording fragment subjected to analysis or suitable for analysis,

b. occurrence of inspirations and expirations,

c. occurrence of pathological phenomena,

(the height of markers corresponds to the intensity of a given pathology in the whole fragment

analysed, using a two-level scale),

d. detected interference that may have an impact on the analysis of the results.

The information on the detected types of auscultation phenomena is presented using four ring fragments

surrounding the above mentioned circle.

Each of the fragments represents a different type of pathological phenomenon.

The thickness of a ring fragment is proportional to the intensity of a given phenomenon, presented in a

two-level scale. The absence of a given fragment means that a given phenomenon has not been

detected. The locations of individual phenomena are described in Figure 2.

Fig.2 Location of pathological phenomena around the analysis result icon.

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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

- Minor intensity of coarse crackles

- Major intensity of fine crackles

Note:

*With asthma control, only wheezes and rhonchi are detected.

Possible markings of site alarm:

No abnormal auscultation sounds have been detected,

A small number of abnormal auscultation sounds have been detected,

Abnormal auscultation sounds have been detected,

Analysis is impossible. No breathing detected or excessive background noise.

In addition to the presentation of the intensity level for every auscultatory phenomenon, a percentage

value (0–100) is presented, expressing the intensity of a given phenomenon in the recording, depending

on the duration of the additional abnormal sound detected during respiratory cycles. The intensity levels

provide an overview of intensity for a given abnormal sound in the recording. With the value, the

physician may precisely differentiate and track the changes in intensity of auscultatory phenomena in

time.

3.5. General Analysis Result for a Single Point with Details

The template for the general analysis results for a single point looks as follows:

●The heart rate (pulse) expressed in beats per minute (BPM) or a “-” mark when the recording

quality makes it impossible to determine the BPM;

●Respiratory rate expressed in breaths per minute (RR) or a “-” mark when the recording quality

makes it impossible to determine the RR.

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