RETINALYZE System

[EN] Retinal investigation medical software

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IFU Master RetinaLyze System Version 1

INSTRUCTIONS FOR USE

The Instructions for Use serves as a manual to use the device safely and effectively.

Thereby we kindly ask you to read the following instructions carefully.

If you need a paper based Instructions for Use, please contact us on: support@retinalyze.com

SUPPORT INFORMATION

All issues regarding malfunctions, lost passwords or a potential security breach are reported through support@retinalyze.com or by calling the company on +45 71 990 321.

DEVICE DESCRIPTION

RetinaLyze System is a cloud based retinal investigation medical software, which functions as a Clinical Decision Support Tool for Eye Care Professionals to investigate the pathological changes in the retina and optic nerve head.

The device is a web application allowing operators to interact with the different sub-systems like RetinaLyze DR, RetinaLyze AMD, RetinaLyze Glaucoma and Eye Specialist Backup (ESB) Module.

The device analyses fundus images and the results are displayed as an annotated overlay photos together with a colorized descriptive text.

RetinaLyze DR and AMD create an overlay photo that marks the position of the changes, found by the algorithm whereas RetinaLyze Glaucoma creates an overlay photo on the optic nerve head (ONH) showing the measured level of hemoglobin.

The Eye Specialist Backup module (ESB) sends a fundus photo of an eye to an ophthalmologist who examines the photo and send a response directly in RetinaLyze System.              

INTENDED PURPOSE

RetinaLyze System is a medical software intended for investigation and identification of pathological changes in the retina and optic nerve head.

MEDICAL INDICATIONS

The device is indicated for investigation of potential pathological changes in the eyes in the management of:

• Minor black lesions on the retina

• Minor white lesions on the retina

• Colour variations in the optic nerve head

The identified potential pathological changes could indicate an early signs of eye diseases like Diabetic Retinopathy (DR), Age-related Macular Degeneration (AMD), Glaucoma.

INTENDED USER

The device is intended to be used by Eye Care Professionals, the ophthalmic nurses, endocrine nurses and optical sales assistants.

USE ENVIRONMENTS

The device is intended to be used in retail and clinical settings, such as at Local Optometrists Primary Eye Care services, Hospitals or Specialist Clinics.

PATIENT POPULATION

The intended patient population consists of general population.

This population include patients having a complete assessment of their vision and general eye health at Hospitals, Specialist clinics or at Local Optometrists Primary Eye Care services.

WARNINGS

Do not use the software for the investigation of the retinal images with bad image quality, as  the patient can be given a false negative or false positive results.

CAUTIONS

The information provided by RetinaLyze System device do not replace a consultation with an Eye Care Professional to determine the further diagnosis options and therapies based on the patient history, and patient characteristics as a part of complete assessment of patients vision and general eye health in both retail and clinical settings.

The interpretation of assigned lesions on fundus images for people up to 40 years of age should be carefully assessed due to reflection in the membrana limitans posterior as they might be falsely interpretated as white lesions or blood vessels as dark lesions.

The interpretation of fundus images for patients who have been diagnosed with or treated for retinal eye-diseases should be carefully assessed, as the patient can be given a false negative or false positive result.

CLINICAL BENEFIT

Investigation and identification of minor white and black lesions and presence of hemoglobin in the Optic Nerve Head.

The device performs consistent retinal investigation and delivers a uniform result based on the retinal fundus image of the eye.

GETTING STARTED

Try form on http://retinalyze.com/try should be filled in and the user will receive a trial contract. After the completion of the trial contract a set of credentials will be sent to the customer.

The user guide on how to get started can be accessed at the following link:

RetinaLyze Webapp

Requirements for using the RetinaLyze System Webapp and for fundus camera and browser compatibility with RetinaLyze System can be seen below in this IFU.

HOW TO USE

The user guide on how to use the device can be accessed at the following link:

RetinaLyze Webapp

INTERPRETATION OF THE RESULTS AND FOLLOW-UP TREATMENT

The results of the automated RetinaLyze System analyses are displayed as an annotated overlay photos together with a colorized descriptive text.

DR ALGORITHM

The DR overlay can be applied and interpreted. A guide on how to understand the output of the analysis and follow-up options can be accessed at the following link:

AMD ALGORITHM

The AMD overlay can be applied and interpreted. A guide on how to understand the output of the analysis and follow-up options can be accessed at the following link:

GLAUCOMA ALGORITHM

The Glaucoma overlay can be applied and interpreted. A guide on how to understand the output of the analysis and follow-up options can be accessed at the following link:

GENERAL SYSTEM REQUIREMENTS

Requirements for using the RetinaLyze System Webapp can be accessed at the following link:

Requirements for the acceptable image quality can be accessed at the following link:

HARDWARE COMPATIBILITY

FUNDUS CAMERA

List of requirements for fundus camera and its compatibility with RetinaLyze System can be accessed at the following links:

BROWSER COMPATIBILITY

List of requirements for browser compatibility with RetinaLyze System can be accessed at the following links:

Reporting of incidents

If, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer through support@retinalyze.com or by calling the company on +45 71 990 321 and to the competent authority of the Member State in which the user and/or patient is established.

Data Security

RetinaLyze system have implemented technical and organizational measures to ensure an appropriate level of security, taking into account the nature, scope, context, and purpose of the processing, and the risks to protect against unauthorized or unlawful processing of Personal Data and against accidental loss or destruction of, or damage to, Personal Data, appropriate to the harm that might result from the unauthorized or unlawful processing or accidental loss, destruction or damage and the nature of the data to be protected, having regard to the state of technological development and the cost of implementing any measures.

Those measures will include, where appropriate, pseudonymizing and encrypting Personal Data, ensuring confidentiality, integrity, availability and resilience of its systems and services, ensuring that availability of and access to Personal Data can be restored in a timely manner after an incident, and regularly assessing and evaluating the effectiveness of the technical and organizational measures adopted by it.

Security measures

The servers for the online application, databases, and data protection (backup) are run and maintained by third parties in professional data centers. Subcontractors are selected carefully and with respect to their security awareness and their expertise based on verified audits and certificates. Some of the relevant safeguards of the following checklist are not shown separately because it is the responsibility of subcontractors or are not published in detail for the sake of maintaining the security of confidentiality.

Access control (Physical)

The access control to the server infrastructure occurs by the spatial structure of the data centre and there through the operator ensured control system. Physical access to the servers is maintained and controlled by subcontractor.

Access control (Logical)

RetinaLyze System has implemented suitable measures to prevent its data processing systems from being used by unauthorized persons.

This is accomplished by:

• Automatic lock out of the user ID when several erroneous passwords are entered. Events are logged and logs are reviewed on a regular basis.

• Automatic time-out of user terminal if left idle, identification and password required to reopen.

• Continuously monitoring infrastructure security.

• Regularly examining security risks by internal employees.

• Role-based access control implemented in a manner consistent with principle of least privilege.

• Remote access to infrastructure is encrypted and secured using two-factor authentication tokens.

• Access to host servers, applications, databases, routers, switches, etc., is logged.

• Passwords must adhere to the RetinaLyze System password policy, which includes minimum length requirements and enforcing complexity.

Transmission control

RetinaLyze System has implemented suitable measures to prevent Personal Data from being read, copied, altered or deleted by unauthorized parties during the transmission thereof or during the transport of the data media.

This is accomplished by:

• Use of adequate firewall and encryption technologies to protect the gateways and pipelines through which the data travels.

• Sensitive Personal Data is encrypted during transmission using up to date versions of TLS or other security protocols using industry standard encryption algorithms and keys.

• Customer sensitive Personal Data and other confidential customer data are encrypted at rest within the system.

• Protecting web-based access to account management interfaces by employees through encrypted TLS.

• End-to-end encryption of screen sharing for remote access, support, or real-time
  communication.

• Use of integrity checks to monitor the completeness and correctness of the transfer of data.

Input control

RetinaLyze System has implemented suitable measures to ensure that it is possible to check and establish whether and by whom Personal Data have been input into data processing systems or removed.

This is accomplished by:

• Authentication of the authorized personnel

• Segregation and protection of all stored Personal Data via database schemas, logical access controls, and encryption

• Utilization of user identification credentials

• Physical security of data processing facilities

• Session time outs

Order control

There are contracts for data processing as far as personal data being processed on behalf of the customer. The processing of personal data on behalf of orders given by the Contractor shall be ensured only by written agreement between the Contractor and the Customer or the datacenter. If serious changes occur in the process, the Customer shall be informed.

The Customer shall be informed about the operational status of the system.
The security of remote maintenance is not applicable as there is no remote control by the Customer.

Availability Control

RetinaLyze System has implemented suitable measures to ensure that Personal Data is protected from accidental destruction or loss.

This is accomplished by:

• Redundant data storage.

• Software exclusion: Breakdown of the servers for independent and autonomous fulfilment of the tasks (shared nothing architecture).

• Multiple incremental data backup.

• Data backups with a timetable which appropriately reflects data changes.

Separation rule according to the principle of earmarking

RetinaLyze System has implemented suitable measures to ensure that Personal Data collected for different purposes can be processed separately.

This is accomplished by:

• The database principle, separation by access control.

• Separation of test and production data.

• Separation of development and production environment.

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