Indications for Use & Safety Information

Please read all following instructions, precautions, and warnings carefully before use.

Indications for Use

The Cardiovascular Suite is a software program that is intended to aid trained healthcare practitioners in the quantitative analysis of vascular ultrasound images in adults, particularly for the measurement of the diameter and its changes on the brachial artery, the diameter and its changes on the carotid artery, the Carotid Intima-Media Thickness, and for carotid plaque analysis.

Contraindications

The Cardiovascular Suite device is not intended for use as a test that provides a direct diagnosis of any cardiovascular disease. It is intended to supplement, not substitute, the physician’s decision-making process for diagnosis and treatment. It should be used in conjunction with knowledge of the patient’s history and other clinical findings.

Precautions and Warnings

Below are a list of Precautions and Warnings for the Cardiovascular Suite. All of the following items are found in their appropriate sections throughout this document as well.

Precautions

• CAUTION: the computer must be a Medical Grade Computer in compliance with EN 60601-1 standard for electrical isolation and safety or a common CE marked personal computer (89/366/EEC) connected to power supply via Medical Grade Isolation Transformer that meets IEC 60601-1 standard for electrical leakage.

• CAUTION: The operating system of the machine where the software is used requires controlled access with user name and password. In addition, a time-out of 15 minutes is recommended in the user session of the operating system where the software runs.

• CAUTION: The operating system where the software runs must be updated.

• CAUTION: An updated antivirus/antimalware software protection should be present in the computer where the software runs.

• CAUTION: If the computer is connected to the network, a firewall should be used to prevent cyber-attacks.

• CAUTION : The Quipu License Key contains your license. Store it in a safe place in order to avoid loss and / or theft.

• Please, note that an Internet connection is needed to obtain and use the Evaluation License

• CAUTION: The B-mode window in the image must have a minimal resolution of 6 pixels/mm. If present, the size of the PWD window in the image must be at least 200x100 pixels.

• CAUTION: The ultrasound device must be suitable for vascular imaging and it must be equipped with a vascular linear probe with frequency greater than 5MHz.

• CAUTION: The ultrasound scanner must be in accordance with the European Regulation (EU) 2017/745 or cleared / registered / licensed by the appropriate regulatory authority.

• CAUTION: If the video converter is used with an AC/DC power adapter, it must be a medical grade power adapter according to IEC 60601-1, current edition.

• CAUTION: The video converter must be connected directly to a USB port on your computer. Do not use hubs or the USB socket on the external keyboard. Use USB 3.0 to maximize performances.

• CAUTION: verify that the video output type and resolution of the ultrasound scanner are compatible with this video converter.

• CAUTION: the AV.io HD must be updated with the last firmware from Epiphan System Inc.

• CAUTION: the video converter must be connected directly to a USB port on your computer. Do not use hubs or the USB socket on the external keyboard. Use USB 3.0 to maximize performances.

• CAUTION: Exclude any noise reduction filter (especially temporal filters).

• CAUTION: pay attention that nothing but the ultrasound image is into the ROI. Please note that the processing can be affected by annotations or any other graphical object that is superimposed to the image. In particular, pay attention that the cursor of the doppler sample volume is not into the ROI.

• CAUTION: the processing can be affected by annotations or any other graphical object that is superimposed to the image into the Doppler Flow ROI.

• CAUTION: the data produced by Cardiovascular Suite are not deleted during the software uninstall procedure. They should be removed manually by deleting the archive folder.

• CAUTION: the backup of the archive folder is recommended before uninstalling/installing the software.

Warnings

• CAUTION: Failure / incomplete / incorrect installation makes it not possible to use the software.

• CAUTION: It is recommended to perform regular backups of the system. The non-operation of the backup could result in permanent data loss.

• CAUTION: if a virus/malware is detected in the computer where the software runs the user should adopt the suitable countermeasures that can include removing our software and re-installing it.

• CAUTION : The Quipu License Key will work only on the computer where it is used for the first time.

• CAUTION: the lack of calibration can generate a software malfunction.

• CAUTION: the processing can be affected by annotations or any other graphical object that is superimposed to the image into the Doppler Flow ROI.

Lifetime

The product lifetime is 2 years from the software build date. In this period, Quipu will provide security updates.

Labeling

The product labeling for the Cardiovascular Suite is comprised of the Manual and Instructions for Use, the login screen of the software as well as in the product license key, and product package leaflets.

Below is a table of all labeling symbols for the Cardiovascular Suite.

Labeling Symbols Table