Diagnocat IFU
Diagnocat IFU
Diagnocat IFU
DIAGNOCAT AI
User Manual
Version 3.2
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the contents of this document is strictly prohibited. All rights reserved
User Manual Information 4
Contact 4
Device information 4
Regulatory Requirements 4
Device Identification 4
Paper copy 5
Customer Notice 5
Key Features of Diagnocat 6
Intended Use 6
Contraindications 7
Warnings, precautions and limitations 8
Compatibility 12
System requirements 12
1. Start with Diagnocat 13
1.1 Sign up 13
1.2. Log in 14
1.3 Reset password 16
1.4 Plans & Pricing 17
1.5 All Patients 19
1.6 Create a new patient 20
1.7 Patient Card 21
1.8 Create a new study 21
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the contents of this document is strictly prohibited. All rights reserved
User Manual Information
This user manual is used solely for the purpose of explaining the use of Diagnocat.
This document cannot be printed or reproduced without the permission of the copyright
holder.
Users are recommended to read this manual carefully before starting using Diagnocat
In addition, this manual may be modified without notice. Also, the manual distributed
with the product may not contain the latest version of the product.
For inquiries related to the product and this manual, please contact the following contact
information.
Contact
Website: http://www.diagnocat.com
Device information
Name: Diagnocat AI
Regulatory Requirements
Diagnocat AI software complies with the following regulatory requirements:
● ISO 13485:2016
● Regulation (EU) 2017/745
Compliance - This medical product software complies with relevant international and
national standards and laws. Information on compliance will be supplied on request;
manufacturer contact details are written above.
Device Identification
The information contained in this document is the exclusive property of DGNCT LLC. All unauthorized use and/or reproduction of
the contents of this document is strictly prohibited. All rights reserved
DGNCT LLC
333 Southeast 2nd Avenue, 20th Floor#563,
Miami, Florida 33131, USA
Phone: + 1 519 619 4212
https://www.diagnocat.com/
Paper copy
To receive a paper copy of this manual, please send an email to
[email protected]. Our team will be happy to provide you with a paper copy of
the manual to you via the postal service.
Customer Notice
This Instructions for Use is intended to assist users in the safe and effective use of the
medical device software described herein. The “user” is considered to be not only the
body with authority over the medical device software but also those persons who use
the medical device software.
This Instructions for Use does not describe the use of the IT equipment on which the
medical device software is installed. Refer to the documentation of the IT equipment
concerned.
Before attempting to use this medical device software, you must read these Instructions
for Use thoroughly, paying particular attention to all WARNINGS, and Notes it contains.
You must pay special attention to all the information given, and procedures described,
in the SAFETY section. In addition, you must pay special attention to on-screen
Messages and On-line Help information containing WARNINGS and Notes that may be
related to the function being executed.
Directions which if not followed could cause fatal or serious injury to a user,
patient or other person, or could lead to clinical misdiagnosis, and/or loss/damage of
patient-related data.
Additional information:
The information contained in this document is the exclusive property of DGNCT LLC. All unauthorized use and/or reproduction of
the contents of this document is strictly prohibited. All rights reserved
1. Diagnocat may improve the function and performance of the product without notifying
the user.
2. Some features of the product may not be available in all countries, languages and
currencies.
3. It is illegal to reproduce and distribute the product without the consent of Diagnocat.
4. Users should read this manual thoroughly before using this product.
5. In order to use the full functions of Diagnocat, please follow the specifications
described in this manual.
6. Backup - Backup is the responsibility of the user and it should never be assumed that
any backup is taking place unless it is actively monitored by the user.
3. Viewing patient images (provides tools for image processing and viewing functions)
Intended Use
The Diagnocat AI automated information system is designed for cloud-based storage
and processing of digital dental images using artificial intelligence. Diagnocat AI has
been developed to automate the activities of dental organizations in radiological
examinations, including examination uploading, screening of diagnostic images, saving,
sharing, editing and drawing conclusions.
Diagnocat AI processes files of any area of the patient's maxillofacial region. Diagnocat
AI is designed for use by medical professionals (dentists, orthodontists, radiologists,
etc.) for education purposes and highlights anatomical areas, common conditions, and
previous treatments.
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the contents of this document is strictly prohibited. All rights reserved
Diagnocat AI automatically produces radiological reports for easier viewing and
documentation of investigation for a particular patient. Diagnocat AI can also be used by
managers and administrators of clinics to document patient treatment history and
maintain personal records.
This is a reusable, non-invasive device for image processing and documentation. The
Software cannot be used to make a decision about the diagnosis, presence or absence
of a disease on the basis of the online screening, without additional investigation.
The Software cannot be used for direct diagnosis and clinical decision making.
Contraindications
Although Diagnocat neural networks are trained on a large diverse dataset it is
necessary to remember that in order for the analysis to work correctly, it is necessary to
exclude studies of poor quality.
Applying the Software to poor quality dental pictures is forbidden. (This can lead to
incorrect data collection)
The Software cannot be used for direct diagnosis and clinical decision making.
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the contents of this document is strictly prohibited. All rights reserved
Warnings, precautions and limitations
It is forbidden to download or transmit any messages or content of any type that may
disregard or violate any of the rights of any party.
It is forbidden to use this Software for any purpose in violation of local, state, national
or international laws.
You may not use this application to publish or transmit any material that is illegal,
obscene, threatening, abusive, slanderous, hateful or embarrassing to any other
person or organization
Diagnocat does not give any guarantees regarding the time required for processing
any request; and if you are faced with an emergency you should not seek assistance
from this guide but instead should call emergency medical service immediately.
Clinicians should review Diagnocat reports concurrently with original images before
making a final determination on a case.
Diagnocat is an adjunct tool and does not replace the role of the clinician. Clinicians
must not use the CAD generated output as the primary interpretation.
Diagnocat is not designed to detect findings other than is listed in paragraph 2.2.
Clinicians should review original images for all suspected pathologies.
All radiographic images must have proper quality. Diagnocat performance may be
reduced on images with poor quality.
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the contents of this document is strictly prohibited. All rights reserved
Diagnocat should be used according to the manual.
In accordance with security and industry best practices, security strategies should
address:
• Physical security restricts unauthorized access to the servers where the Diagnocat AI
product is running.
• Security policies, for example, ensuring that client systems are in line with the
institution's IT security policies.
• Awareness Training.
• Contingency planning.
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• Backup
The practical implementation of technical security elements varies by the institution and
may employ a number of technologies, including firewalls, virus scanning software,
authentication technologies, etc. As with any computer-based system, firewalls and
other security products must be in place between the medical system and any externally
accessible systems or users.
Regulatory Controls
One of the most important assets to protect with security measures is the patient health
information (PHI). Many governments require maintaining the confidentiality of this
information. Therefore, strict security measures must be taken to guard this protected
information. (Users in the USA may find guidelines at http://www.hhs.gov/ocr/hipaa/).
The Diagnocat AI software does not store the patient's health information. However, the
information transferred to the product is not encrypted. Unencrypted patient health
information will be present in transferred DICOM data and algorithm analysis results.
Thus, particular care must be taken with this information to ensure the utmost security
and confidentiality in data transferring to and from the product.
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the contents of this document is strictly prohibited. All rights reserved
CAUTION: It is the whole responsibility of the user to guard removable
media, which contains sensitive private information, at all times.
Make sure the equipment is connected to a local network that uses appropriate
protection, such as a virus scanner.
When using removable media like USB storage products, CDs, DVDs, be aware that
inserting removable media can introduce a virus to the medical product.
Users and owners of this medical equipment must permit only Diagnocat authorized
changes to be made to this product, either by Diagnocat personnel or under Diagnocat
explicit published direction.
Regular users do not have direct access to Diagnocat AI software. Only authorized
specialists (like institution’s IT specialists/administrators, Diagnocat AI software
administrators) have access to the product. However, they have privileged access
which requires strict control.
● Allow access only to the personnel who is responsible for service and administration
of the product;
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the contents of this document is strictly prohibited. All rights reserved
● Ensure periodic change of passwords.
Product Environment
External circumstances can influence the availability of the product and its operation,
e.g. network failures, power failures, environmental disasters, etc.
Take appropriate controls to ensure the reliability of the environment in which the
product is used.
Advise the users of the product and analysis results to contact Diagnocat promptly and
report about occurred security events to allow Diagnocat to respond to the incident with
no delay.
Compatibility
The medical product software described in this Instructions for Use should not be used
in combination with other software, equipment or components unless such other
software, equipment or components are expressly recognized as compatible by
Diagnocat AI.
Changes and/or additions to the medical product software should only be carried out by
Diagnocat AI or by third parties expressly authorized by Diagnocat AI to do so. Such
changes and/or additions must comply with all applicable laws and regulations which
have the force of law within the jurisdiction concerned, and with best engineering
practice.
System requirements
Diagnocat software requirements:
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- DICOM
- JPEG
- TIFF
- PNG
configurations
Diagnocat AI can be configured in 2 options:
1. You can upload patients' studies manually using a web-browser that doesn't
require any specific configuration.Please contact your sales representative or
email [email protected] for more information.
2. Desktop integration. DC Desktop App is an application that can capture dental
images from imaging software and upload them to Diagnocat Web Application.
Please contact your sales representative or email [email protected] for
more information.
1. Sales team
*It’s also available to book a phone call with our Sales manager in order to speed
up the process.
- Our friendly Sales team will get in touch with you shortly afterwards. They will be
able to assist you with account creation and choosing the right subscription
option for your business.
2. Signup form
You will be prompted to the account creation screen where you need to provide account
details and click the “Create Account” button.
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the contents of this document is strictly prohibited. All rights reserved
NOTE: It’s important to note that specifying your country is critical. There are two main
reasons for that:
1. We don’t offer Diagnocat services in the countries where we don’t have an official
approval from medical authorities.
2. Each country has its own set of products and pricing policy.
1.2. Log in
Open Chrome browser and go to www.diagnocat.com.
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the contents of this document is strictly prohibited. All rights reserved
Click the “Login” button.
You will be able to log in to the Diagnocat application by providing your email and
password.
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the contents of this document is strictly prohibited. All rights reserved
1.3 Reset password
If you need to reset your password, click the Reset Password link and enter your email
address you used to register your Diagnocat account.
You will receive an email with instructions on how to reset your password.
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the contents of this document is strictly prohibited. All rights reserved
1.4 Plans & Pricing
To start using Diagnocat you need to buy a subscription plan that will give you access to
the main functionality.
Step 1: Go to your Account Setting and select the Plans & Pricing tab.
Step 3: For the first payment, you will be asked to provide your billing information and
phone number, so we can keep it on file.
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the contents of this document is strictly prohibited. All rights reserved
Step 4: After you provide your billing information, you will be prompted to Stripe where
you can complete your purchase.
Once you finish, you will see your purchase on the Billing History tab, where you can
also download your invoice and view your usage.
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the contents of this document is strictly prohibited. All rights reserved
NOTE: Without an active subscription or package (for corporate clients only) you will
only be able to view a Demo case. You won’t be able to create patients, upload new
studies or order reports.
#2: Using the “Search” field you can search for studies by patient name, treating doctor
or ID.
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the contents of this document is strictly prohibited. All rights reserved
1.7 Patient Card
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1. Select the study type you want to upload
Diagnocat supports the following file formats: *.dcm, *.jpg, *.png, *.tiff
With 3D reports, only the Radiological Report can be generated automatically during
CBCT file/s upload.
To order other reports go to the patient's card, choose the type of study and order the
report by clicking “Order report”.
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the contents of this document is strictly prohibited. All rights reserved
2.0 Radiological Report
You can open a radiological report by clicking the link.
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the contents of this document is strictly prohibited. All rights reserved
#1: Patient details
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2.1 Panorama tools
#2: Sharpness
#3: Zoom in
#5: Invert
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the contents of this document is strictly prohibited. All rights reserved
2.2 Tooth chart
Red lines (one, two or three) - periodontal screening (periodontal bone loss mild,
moderate or severe stage)
NOTE: by default, all the teeth are enabled and for each tooth there is a tooth card. You
can disable some teeth. Use the “Choose region of interest” option to select what teeth
you would like to have in the report.
If the tooth numbers are incorrect, use the “Edit teeth number” option.
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2.4 Orthodontic screening module
This module is for detection of dental and skeletal discrepancies.
To achieve the most accurate indicators, it is recommended to do a study with closed
teeth.
NOTE: Yellow attributes don't appear in the report. If you click the "Approve" button, the
yellow attributes become the red one. Then they will appear in the report.
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2.6 Tooth card
You can find detailed information about a specific tooth inside the tooth card.
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2.7 All Slices Mode
#1: Main panel that allows to view and edit detected pathologies and conditions. All
pathologies and conditions are grouped according to the anatomical and topographic
features in the form of tabs.
#2: A list of detected pathologies and conditions. You can also change a tooth by
clicking a tooth number.
#4: The “Panorama” button. This button will show a panorama and tooth chart on top of
existing slices.
#7: The “Approve” button. When clicked this button lets the system know that a user has
not changed anything and approves the detected pathologies and conditions. Or if the
user has made edits and confirms changes.
NOTE: Each pathology has %. This is the level of confidence Diagnocat platform has in
regards to the found pathology. If the likelihood of a pathology is less than 50% then the
system won’t show it in the report. The user can still see this pathology on the slices.
Click the “Change slices”, then click a slice you want to delete. If you want to remove all
slices then click the “Remove all” button.
If you want to add your image, use the “Additional slices” option.
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After you finish removing / adding slices, click the “Save slices” button.
2.9 3D Viewer
#1: You can edit information in this section. Changes will be available inside the tooth
card.
#3: Brightness/contrast
#5: Zoom
#8: Enable/disable axes. Disable axes if you want to end a slice to the tooth card.
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#9: Download slices as JPEG files
2.10 Conclusion
Add a conclusion to the report, attach a link or an image.
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Also to sign a report you need to approve all detections of all selected teeth. If any
detection is not approved, the system will give you a warning.
If all teeth are approved, click the “Sign” button and then the “Print” button.
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A note added to the bottom of every page of the report: “This report was generated with
Diagnocat using Artificial Intelligence. The conditions and pathologies in this report can
not be considered a medical diagnosis and must be interpreted by the attending
dentist.”
#1: Select clinic to add clinic’s information and branding to the report.
#2: Select a report type (Full or Motivation). In the Motivation version there will be only a
panoramic image and the tooth chart.
#4: Enable / disable the likelihood of pathologies and conditions in the report.
#5, #6, #7: Enable / disable the tooth chart and upper and lower jaws in the report.
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#10: Enable / disable referral recommendations in the report.
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#1: STL of teeth and maxillomandibular anatomy in one file
#2: STL of teeth and full anatomy (maxilla, mandibula, airways, cranial base) as
separate files
Once you click the“Order” button, the system will start generating a new report. It will
take a few minutes. Once it’s finished, you will see a new report in the list.
Inside the STL viewer, using the navigation panel on the left you will be able to:
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- change transparency of the model’s elements
4.0 Superimposition
Diagnocat allows you to create IOS-CBCT Superimposition. In study choose STL, click
“New” and upload the file or folder.
*Note: you need to upload one of the following file types: *STL, *OBJ, *PLY, *DRC.
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4.0 Panoramic Report
When you open a panoramic report for the first time, the system will ask to confirm the
teeth numbers.
After confirmation you will be able to start working with the report. The panoramic report
has the exact same tools and functionality that are used in the Radiological Report.
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#1: Tool panel
The intraoral report has the exact same tools and functionality that are used in the
Radiological Report.
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the contents of this document is strictly prohibited. All rights reserved
NOTE: In case there is a validation conflict. The system will ask you to check teeth
numbers. The red marked images have tooth-duplicates. The system won’t allow
complete validation until it’s fixed.
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the contents of this document is strictly prohibited. All rights reserved
Click the “Share” button. There are two ways to share a patient’s study:
Enter the recipient email address and click the “Send invite” button.
On the left side in the menu “Shared with” you will see a list of doctors a patient study
has been shared with.
A doctor who you share a patient study with will receive an email notification inviting
them to go to Diagnocat.
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the contents of this document is strictly prohibited. All rights reserved
If the doctor doesn’t have a Diagnocat account, they will be able to create a new one by
entering a secure password. Once finished they will be prompted to their account where
they can view reports of the shared patient.
NOTE: A new Diagnocat account a doctor creates is a full Diagnocat account that they
can use from other devices. This account will have limited functionality. They will be
able to view and edit only existing data and reports until they purchase their own license
#2: Organization. You can add, delete and edit clinics so you can use different
branding when printing reports.
#3: Staff. You can add, remove and edit employees, as well as resend an invite.
#4: Billing history. You can view your current plan, packages, consumption and
invoices. You can also pay and download your invoices. Additionally you can cancel
your current plan. What it does is cancel your recurring payment. You will still have an
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active plan but it will not renew when a new billing cycle starts.
#5: Plans & Pricing. You will be able to view available in your region plans and
packages you can purchase.
#6: When you click the “Go back to my patients” you will be prompted to your patient
list.
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In case you want to expand the amount of uploads, please follow these steps:
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manufacturer’s website for the updated contact info: https://www.diagnocat.com, if
necessary.
CH-REP
Freyr Life Sciences GmbH,
Bahnhofplatz,
CH-6300 Zug,
Switzerland
Tel: +41 225083729
email: [email protected]
Please report of any serious incident that has occurred in relation to the device injury or
adverse event to the local competent authority and to [email protected]
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the contents of this document is strictly prohibited. All rights reserved