Notice

Sonio Diagnostics  is a trademark of Sonio.

All other trademarks and registered trademarks are the property of their respective holders.

All rights reserved. U.S. Federal law restricts this device to sale by or on the order of a dentist or physician.

The screenshots in this publication may deviate from the software installed on your PC. All patient data are fictitious.

No part of this guide may be reproduced without the express permission of Sonio.

Manual Name: Sonio Diagnostics

Revision: 01

Date: 2022-01

This document is originally written in English.

Manual presentation

Safety warning types

Warning: Warns you to avoid injury to the patient by following the safety instructions precisely.

Note : Emphazises important information

How to access the User Manual on the software

Access to the User Manual can be done from the left menu navigation panel and clicking at the bottom left of the panel then „User Manual“.

Revision History

Safety and regulatory instructions

Intended purpose/Indications for use     

Sonio Diagnostics is a clinical decision support tool intended as an aid for qualified healthcare professionals to analyse and diagnose ultrasound-visible fetal anomalies/diseases and related pathological syndromes during performance of prenatal sonography, in combination with other relevant clinical information and reference guidelines. 

Patient management decisions should not be made solely on the basis of analysis by Sonio Diagnostics.

Contra-indications:

There are no contra-indications to the use of Sonio Diagnostics clinical decision support software.     

Intended Users: 

Sonio Diagnostics intended to be used by qualified healthcare professional personnel in a professional prenatal ultrasound (US) imaging environment.

Intended use environment: 

Sonio Diagnostics is intended to be used in a healthcare environment during ultrasound examination.     

Target population: 

Intended patients are pregnant women from 11 weeks of amenorrhea with a first screening ultrasound presenting isolated, combinated and/or syndromic anomalies.

Thesaurus

The final Sonio Diagnostics’ V2.0 thesaurus comprised 423 syndromes and disorders with a prevalence of between 1/400 (Down syndrome) and very rare (i.e. for which the prevalence is unknown but for which only case reports exist). Each of these disorders was linked to a total 774 possible ultrasound anomalies.

Regulatory:

Sonio Diagnostics V2.0 is not yet CE marked

For U.S. only: Federal law (USA) restricts this device to use by or on the order of a physician.

Reporting of serious incident:

Any serious incident that has occurred in relation to the device should be reported to the Sonio and the competent authority of the Member State in which you are established.

A Serious incident is any incident that has resulted directly or indirectly, may have resulted in or likely to result in:  

(a) the death of a patient, user, or other person, 

(b) a serious temporary or permanent deterioration in the health of a patient, user or other

person, 

(c) a serious threat to public health. 

Warning and Notice

Warning: Patient management decisions should not be made solely on the basis of analysis  

                  by Sonio Diagnostics. You are ultimately responsible for the final diagnosis.

Note : The list of diagnosis suggested by Sonio Diagnostics is based on the information you

             entered and those information need to be accurate and complete.

Data protection and security

All data are compliant with RGPD regulation. Data transmission are also compliant with applicable regulations (RGPD, HDS)

All data within the Sonio Cloud is encrypted in transit and at rest.

Network Requirements

The device on which the Sonio application is used must be connected to the internet

and be able to access https://dx.sonio.app. There is no requirement to be on any

specific network since Sonio does not and need not communicated with any other

devices or information systems.

1. Login to the application

1.1 Is this my first time logging in?

• You should have received an invitation to create your account
• Click on the link, fill in all the fields, then click on „Register“.
  • Note that your password must be strong enough to ensure the security of your account.
  • To have a strong password, make it as long as possible and with various types of characters (a-z, A-Z), symbols (/,;!#@=+.), and numbers (1-9).
• If the link does not work or you encounter difficulties setting up your account please contact us at [email protected] so that we can send you a new invitation link.

1.2 How to connect to Sonio?

• Access the Sonio application from any web browser by entering the following address: dx.sonio.app
• Enter your email address (the same as the one you used to create your account)
• Enter your password
• Click on Login

1.3 How to recover your password?

• Go to dx.sonio.app
• Click on „Forgotten Password?“.
• Enter the email address you used to create your account
  • If you have forgotten your email, write to us at [email protected]
• Validate and you will receive a link in your mailbox
• Access to your mailbox and click on the link
• Set a new password

2. Diagnostic examination

2.1 How to start an examination?

2.1.1. Through the burger menu

To quick-start a Diagnostic examination from any page :

• First, click on the „burger menu“ (panel icon) on the top left
• Then, click on the trimester of the diagnostic examination you want to start

2.1.2. From an unusual exam item

• When an exam item is indicated as unusual, you can enter a Diagnostics exam directly from this entry point clicking on „Detail the unusual… on Diagnostics“

2.1.3. From the search bar available at the top of the screen within an exam

• When on any exam, you can access a search bar at the top of the screen
• By adding an anomaly or medical history risk factor you trigger a Diag exam and access it’s workflow

2.2 What are the different parts of the screen?

2.2.1 Burger menu

The burger menu gives you access to :

• Sections outside Sonio Diagnostics (Dashboard, Patient folders, Options & user preferences, …)
• Access regarding your current examination
  • Medical history of the patient : Once the examination has started, you can easily access and complete / modify the information given in the medical history at any time.
  • General Examination (non-diagnostic)
  • Diagnostic exam
  • A button to end the examination and access its report
• Shortcuts to start in 1 click a new diagnostic examination for the first, second or third trimester
• Privacy policy, User manual, Terms Of Use with UDI & Label of the app

2.2.2 The search bar

The search bar allows you to search different items present in Sonio database :

• Signs
• Anomalies
• Risk factors
• Drugs (teratogen or not)
• Diseases / Diagnostics available within Sonio’s database to be ‚pinned‘ (once pinned a diagnostic can be reviewed in details in the summary)

2.2.3 Patient information

By clicking on the name of the patient, you can access and edit patient information

2.2.4 The fetus and the validation button of the fetus region

The fetus representation indicates the region being analyzed, in white (in this example the cephalic pole).

This part also allows you to navigate between the different regions of the fetus by simply clicking on the desired region.

The validation button allows you to indicate that nothing unusual have been detected in the currently analyzed region.

The horizontal bar below indicate in white the currently selected region and in solid blue the regions that have been fully validated. It helps you identify quickly if there are remaining regions to check/validate.

• When anomalies will be suggested by the algorithm as ‚important‘ to check in a given region, the given region will be edited to show a pulsating white dot
• When anomalies have been added to a given region, this region will be marked with a small (purposely not alarming in case patients may look at the screen) yellow dot on the region of the fetus

2.2.5 Anomalies to check

The list contains anomalies Sonio suggests you to check within the currently analyzed fetus region.

• By clicking on the anomaly, it will be added to the phenotype of the fetus
• By expanding the anomaly, you can view a list of potentially linked syndromes in which this anomaly is present and you can declare it as
  • Absent
  • Maybe present
  • Present

2.2.6 Summary

At any time during the examination, you can access the summary by clicking the bottom left button.

The summary allows you to consult the diagnostics suggested by Sonio on the basis of the information entered (phenotype and risk factors).

The reliability of the diagnosis is represented by a gauge in the circular arc on the button itself.

With „p“ being Sonio’s Proximity Score of the top result if :

• p < 0.8  ⟶ diagnostic reliability is 1
• 0.85 > p >= 0.8  ⟶ diagnostic reliability is 2
• 0.9 > p >= 0.85  ⟶ diagnostic reliability is 3
• p >= 0.9  ⟶ diagnostic reliability is 4

(See section 3 for more information about the contents of the summary)

2.2.7 Phenotype and medical history items

• The phenotype section contains anomalies/signs declared as present, maybe present or absent in the phenotype
• The medical history section items identified in the patient’s medical history (accessible through the burger menu at any time during the examination) or through the contextual questions that may be asked during the examination.

• The notification sticker on the bell indicate the number of risk factors AND anomalies identified during the examination.

• If no risk factors and anomalies/signs have been entered the notification sticker does not appear.

2.3 What is the purpose of medical history ?

Medical history items allow Sonio to be more efficient when identified as risk factors by Sonio.

The information provided as risk factors will guide the diagnostic path and allow the best diagnostic to be made more quickly.

Note that it is not necessary to complete the entire initial medical history in order to begin the examination since only risk factor will be accounted for. Questions relating to the patient’s history may be triggered automatically at a later stage to enable a better diagnosis.

2.4 How to add items to the medical history ?

You have different ways to add items to the patient’s medical history.

2.4.1. Medical history

• Click on the burger menu
• Then click on the Medical history button

You can now add Medical history items from the different sections. A bell will appear on the section to notify you whether or not the item added will be taken into account by Sonio to better inform the diagnostic.

2.4.2 Search bar

Thanks to the search bar you can add the followings items in the medical history :

• A risk factor
• A drug, teratogen or not

2.4.3 Live contextual questions

Questions related to the medical history of the patient may appear during the examination to help Sonio make the most accurate diagnostic possible. They are not mandatory and can be skipped.

2.5 How to know if the medical history item have been taken into consideration ?

When you add a medical history item, it will appear in the medical history section of the examination page.

If the medical history item added is a risk factor and will be taken into consideration to better inform diagnostics, a notification sticker will appear or will be incremented on the bell.

2.6 How to add items to the phenotype ?

2.6.1 Click on a anomaly

By clicking on an anomaly in the list proposed by Sonio, this anomaly will be directly added to the phenotype and will be displayed in the phenotype section.

An anomaly will be displayed in yellow if declared as present in the phenotype.

2.6.2 Through the search in the bar

You can manually add an anomaly through the search bar by typing at least 3 characters contained in the name of the anomaly or one of its synonym. By clicking on it, it will be added to the phenotype.

(see 2.12 : How to add an anomaly manually ?)

2.6.3 Through the ‚V‘ symbol

On the list of anomalies to check in the current zone, anomalies are displayed with a V-symbol to the right.

The ‚v‘ symbols to the right of the anomalies allow you to indicate ‚yes‘, ’no‘ or ‚maybe‘ as to whether the anomaly is present.

By declaring an anomaly as absent it will appear in the phenotype in the „Absent signs“ section and will be taken into account to inform the list of potential diagnostics.

By declaring an anomaly as maybe present, it will appear in blue in the phenotype.

2.6.4 Through the summary

You can also edit phenotype through the summary page by adding or removing some items.

See section 3 to get more details about the summary.

2.7 How to remove items from the phenotype ?

Anytime during the examination, you can remove items from the phenotype by clicking on the cross next to an anomaly in the phenotype section.

Note you can also indicate the anomaly as „MAYBE“ present by clicking the label of the anomaly itself (in this ex: „Flat face“). The anomaly then changes color to the light blue to show it’s now ‚maybe‘ present.

2.8 What happens when I validate the presence of an anomaly?

(1) Sonio will propose you a list of potential anomalies related to the previously selected item, to be checked to advance the diagnostic. For each anomaly, Sonio specifies on the right hand side to which syndrome/disease the anomaly may be related. By clicking on the ‚v‘ symbol to the right of the anomaly, you will be able to see all the diseases / syndromes that are considered in the context of this anomaly by Sonio. The ‚v‘ symbol at the bottom of the list allows you to scroll through the list of suggested anomalies.

• Note: it is always possible to add an anomaly manually through the search bar at the top of the screen.

(2) The yellow circle means there is an anomaly declared as present and linked to this region.

(3) The white circles indicate areas where anomalies may occur in relation to those already selected. Sonio recommends that these areas are checked as a priority after the current area.

2.9 What does the yellow dot on the fetus indicate?

The yellow circle means that an anomaly detected as present is visible in this region.

2.10 What does the white dot on the fetus indicate?

The white circle indicates an area where anomalies may occur in relation to those already selected. Sonio recommends that this area be checked first, after the current area.

2.11 How do you indicate that an entire region is free of anomalies?

Click on „Nothing else, go to …“ to:

• Indicate that none of the „to be checked“ anomalies are visible
• Validate the current region
• Move on to the next most important region to check (white dot if available otherwise next available region)

2.12 Why am I asked questions during the exam?

Questions related to medical history / questionnaire may appear in the medical examination section to help Sonio make the most accurate diagnosis possible. They are not mandatory.

2.13 How to add an anomaly manually?

The search bar at the top of the screen allows you to manually add an anomaly detected during the examination (3.2)

After clicking on the search bar, you can add anomalies manually

The results are filtered by each letter you enter in the search bar. You can forget accents and capital letters, the results of your search will remain the same.

Note that you may come across a synonym. Synonyms appear in brackets in the search results and choosing a canonical name does not affect the results.

2.14 How is semiology integrated into the examination?

When you indicate the presence of an anomaly, Sonio gives you the choice of characterizing the anomaly as an isolated anomaly or clicking on a more complex anomaly that includes the anomaly you initially indicated (when available).

Here, after entering a bilateral ventriculomegaly vl 10 to 15mm, Sonio gives you the choice between :

• Characterizing this ventriculomegaly as an isolated anomaly by clicking on „Ventriculomegaly – a priori isolated“.
• Click on a more complex anomaly described in part by this ventriculomegaly

2.15 How to finish the exam?

You can finish the examination even if there are still elements to be verified, or if the reliability score of the diagnosis is not maximal

2.15.1 Through the summary

• Click on the „Summary“ button at the bottom left of your screen
• Click on „Go to the report“ button at the bottom right of your screen

2.15.2 Through the burger menu

• Open the burger menu at the top left of the screen
• Click on „End the examination“ button

2.16 How to pin a syndrome ?

To pin a syndrome to the list of diagnostics will allow you to consult its details regardless of the item you added to the phenotype or the medical history.

2.16.1 Through the search bar

To pin a syndrome, you can search it through the search bar and click on the Pin this syndrome button.

2.16.2 Through the summary

By clicking on a diagnostic in the list displayed in the summary, you can pin a diagnostic thanks to the pin button at the top right of the screen.

2.17 How to discard a syndrome ?

You can discard from the list of diagnostics to remove it from the list of diagnostics proposed by Sonio if you consider it as not relevant for the current examination.

To do so, you need to access details of a syndrome by clicking on it, then click on the discard button at the top right of the screen.

You can revert you action by finding the discarded syndrome at the bottom of the Summary screen and clicking on the discard icon.

3. Summary

3.1 How to analyze the summary made by Sonio?

(1) On the top of the screen, Sonio informs you whether if the most probable diagnostic is a syndrome, an isolated anomaly or an association of anomalies. This sentence takes into account the Proximity Score computed by Sonio on these top results and will sometimes show no clear result has been found by Sonio.

(2) At the bottom of the screen, Sonio informs you about the reliability of the diagnostics proposed.

The reliability of a diagnostic can be low. Some information you could enter may be missing, check if all areas have properly been checked.

Areas checked are represented in blue in the gauge so that you can easily check if some regions have not been fully validated yet.

(3) The phenotype section shows the list of anomalies identified during the examination as present, absent or maybe present. This list can be edited.

(4) The „medical examination“ section shows items from the patient’s medical history that are either risk factors, live questions or CGH (important filter for the diagnostic that will always show here)

(5) The list of diagnostics (isolated anomalies, incidental anomaly combinations or possible diseases/syndromes) is available on the right-hand side of the screen.

• These diagnostics are ordered by probability, based on the information provided during the examination (phenotype + medical history items)
• The details of a diagnosis are available by clicking on it
• For each diagnostic you can see characteristic anomalies of the syndrome, which you have not yet dealt with during the examination. You can answer them directly from this screen or you can return to the examination to make the necessary checks.

(6) Clicking on „Return to examination“ allows you to go back to the examination and do some modifications.

(7) Clicking on „Go to report“ ends the diagnostic analysis of Sonio. Please note that this action is not reversible. If you wish to continue the examination, click on „Back to the examination“.

3.2 How to interpret the details of a diagnosis given by Sonio?

By clicking on a diagnostic, you can access details about it.

(1) Phenotype matching tab which contains :

• The matching score over 10 representing the probability of occurrence of the syndrome based on the information provided during the examination
• The prevalence in the population for this diagnostic
• The list of typical signs for the diagnostic. For each sign/anomaly you can see if you declared it as present (in yellow), absent or unknown. Anomalies marked ‚absent‘, are anomalies that are normally visible in the context of this syndrome, but that you have indicated as absent during the examination (explicitly or implicitly by indicating that you do not see them in the area by clicking on „nothing else…“)
• The list of discrepancies contains any anomaly you declared which is discordant with the list of typical sign for this diagnostic and not typical of the syndrome in question.

You can easily see which anomalies of the phenotype are concordant or not with Sonio’s list of typical sign for the diagnostic

(2) Risk factors of the diagnostic. Risk factors you added to the patient’s medical history and which are concordant with the risk factors of the diagnostic are displayed in yellow.

(3) Publications related to the diagnostic

(4) Next steps or ways/tests to confirm the diagnostic and potential future anomalies linked to the diagnostic.

(5) You can pin a diagnostic to make sure it will be present in the list of diagnostic and to be able to consult its details even if changes in the phenotype are made

(6) You can discard a diagnostic to move it from the list of diagnostics proposed by Sonio

4. Finish the exam

4.1 How to finish the exam?

You can finish the examination even if there are still elements to be verified, or if the reliability score of the diagnosis is not maximal.

4.1.1 Through the summary

• Click on the „Summary“ button at the bottom left of your screen
• Click on „Go to the report“ button at the bottom right of your screen

4.1.2 Through the burger menu

• Open the burger menu at the top left of the screen
• Click on „End the examination“ button

4.2 What are the different information and features I can access after completing the exam?

On report page, you can consult all the information of the exam which are accessible by clicking on the tab of your choice on the left of the screen OR by scrolling down with the mouse.

4.2.1 Diagnostic – Dashboard tab

The Dashboard section allows you to download the report in PDF or easily send the report to your own secured health messaging system.

4.2.2 Diagnostic – Overview

The Overview tab includes :

• Informations about the examination and the patient
• A summary of zones checked and unusual because you identified an anomaly in this zone
• Risk factors & tests
• Anomalies raised during the exam
• A reminder of the top 3 diagnostics, their proximity score and the reliability of the overall results. By clicking on the details button of a diagnostic, you will be directly redirected to the result tab on this specific diagnostic.

4.2.3 The results tab

The results tab contains details about the diagnostics proposed by Sonio :

• Matching score and prevalence
• Phenotype (showing matching anomalies and discordants when relevant)
• Risk factors (if available)
• Publications (if available)
• Next steps (if available)

4.3 Can I still modify an exam after I have completed it?

4.3.1 You can modify an exam by accessing it from the left panel Menu

Click on the burger menu then click on the Diagnostic button.

5.4 How to get the report in PDF format?

Click on „Download (.pdf)“ to get the report directly in PDF format, or send it to your secure health messaging system by clicking on „Send me the report“.

6. Contact information

It is thanks to your feedback that we are building an application that is more useful for and relevant to your daily practice.

Do not hesitate to contact us at [email protected].

Manufacturer’s address