COROVENTIS^‡ COROFLOW^‡ CARDIOVASCULAR SYSTEM

Important Safety Information

  Coroventis^‡ CoroFlow^‡ Cardiovascular System

Indications: CoroFlow^‡ is indicated to provide hemodynamic information for use in the diagnosis of patients with cardiovascular diseases.

CoroFlow^‡ is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display various physiological parameters based on the output from one or more measuring devices.

Contraindications: The system has no patient alarm functions. Do not use for cardiac/vital signs monitoring.

Warnings:

• If CoroFlow^‡ is used together with 3rd party infusion catheters for assessment of Absolute Flow and Resistance, ensure that the maximum infusion rate per manufacturers instruction is not exceeded or vessel injury may occur.
• Do not use the CoroFlow^‡ measurement system if there is reason to believe the system's security has been compromised or if the system was unaccounted for a period of time (i.e. misappropriated, modified or tampered with).
• Do not leave the CoroFlow^‡ measurement system unattended when logged in as a PC Administrator
• To protect the privacy and security of sensitive information, including electronic protected health information (EPHI), and to protect the integrity of the system itself, the system should be located in a physically secure, access-controlled environment.
• To protect the privacy and security of sensitive information, including electronic protected health information (EPHI), the PC on to which CoroFlow^‡ is installed must be configured according to the Installation Instructions in this manual. Failure to configure the PC correctly may result in increased risk for unauthorized release of protected health information. Windows settings include:
  • Activation and configuration of restricted user Access
  • Activation of Windows Firewall and blocking of network connections
  • Activation of Windows Bitlocker drive encryption
  • Activation of Windows Secure Boot
  • Activation of Windows Anti-Virus scanning
  • Activation of Windows update
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• Use of accessories, transducers and cables other than those specified or provided by Coroventis^‡ could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of CoroFlow^‡, including cables specified by Coroventis^‡. Otherwise, degradation of the performance of this equipment could result.

Precautions:

• The PC and CoroHub^‡shall not be placed within the patient environment (1.5 m from patient).
• For operation of other devices used in conjunction with CoroFlow^‡ consult the IFU for each of these devices for details on indication, handling and safety information.
• It is recommended to ensure local routines for data backup of stored recordings. CoroFlow^‡ does not create backup of stored data.
• Always check minimum performance requirement on PC to ensure compatibility with CoroFlow^‡.
• It is recommended to install CoroFlow^‡ on a PC with backup battery to avoid interruption in case of power failure.
• Always manually review and confirm valid cursor positions and detected heart beats.
• Ensure that Pa and Pd pressure waveforms are aligned in phase and offset after equalization, or indices can be mis-calculated.
• Confirm that the correct Wi-Box is selected by manually matching the Wi-Box ID number with the Wi-Box in the lab.
• Changing parameter settings outside of default values may affect measurement performance, only for research purposes.
• Only to be used by healthcare professionals
• Using a network location to store data may cause previously unidentified risks if the network malfunctions
• The assembly of medical electrical systems and modifications during the actual service life require evaluation to the requirements according to IEC 60601-1 standard series.
• CoroHub^‡ does not have any serviceable parts and require no field maintenance. No modification or tampering with CoroHub^‡ is permitted.
• CoroHub^‡ shall not be immersed in liquid.
• CoroHub^‡ shall not be used if it has been subject to damage
• Direct connection to a non-secure network, like the internet, may interfere with correct operation and/or result in inappropriate access to patient information. Furthermore, it should be noted that reconfiguring a used network may lead to inability to import patient as well as export examination data, ultimately leading to a risk of loss of patient and examination data. To avoid this problem Coroventis^‡ recommends verifying network settings in the system setup after each change.