the pulse generator or install any supporng elements, such as a rewall, to safeguard paent informaon
and device data. The following safeguards are provided:
▪ To prevent unauthorized data access, the pulse generator encrypts the paent name and other sensive▪
informaon.
▪
To prevent unauthorized data changes, the pulse generator (when updated with the latest soware) limits
▪
programmed therapy changes to authorized devices.
▪ To prevent unauthorized device access that could lead to premature baery depleon, the pulse▪
generator (when updated with the latest soware) disables wireless communicaon aer excessive
usage. The programmer displays an alert aer this occurs and automacally re‑enables wireless
communicaon.
Abbo Medical pulse generators are shipped with the latest soware updates installed. If a pulse generator
soware update is available, the programmer will automacally oer to install it on exisng pulse generators.
You should upgrade the pulse generator when soware updates are available to ensure you have the most
current safeguards available.
All safeguards for the devices will be provided throughout the stated warranty period or unl a replacement
product is available. In the rare event that the cybersecurity is compromised on the pulse generator, therapy
will connue to be available to the paent, and the device will operate in the hardware backup mode. For
details on this mode refer to the Bradycardia and Tachycardia Devices Help Manual. The cybersecurity bill of
materials (CBOM) is available upon request.
Warnings
To prevent permanent damage to the device and ssue damage at the electrode/ssue interface, avoid
exposure to the following:
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