Abbott Endurity Core - MRI Safety Information; Data Security

MRI Safety Informaon
MR Condional pulse generators and CRT‑Ps are condionally safe for use in the MRI environment when used
in a complete MR Condional system and according to the instrucons in the MRI‑Ready Systems manual.
Scanning under dierent condions may result in severe paent injury, death, or device malfuncon.
Summary of Safety and Clinical Performance
A summary of the safety and clinical performance for this device is available at
hps://ec.europa.eu/tools/eudamed. Search for the device using the Global Trade Item Number (GTIN; also
known as UDI) provided on the Informaon screen of the clinician programmer applicaon. This is the SSCP
locaon aer the launch of the European Database on
Medical Devices/Eudamed.
Contraindicaons
Implanted Cardioverter‑Debrillator (ICD). Single‑chamber pulse generators, dual‑chamber pulse generators,
and CRT‑Ps are contraindicated in paents with an implanted cardioverter‑debrillator.
Single‑Chamber Ventricular Demand Pacing is relavely contraindicated in paents who have demonstrated
pulse generator syndrome, have retrograde VA conducon, or suer a drop in arterial blood pressure with the
onset of ventricular pacing.
Data Security
Abbo Medical
takes a broad and deep approach to ensuring the safety, security, and privacy of the paent
informaon and data on our devices and systems connecng paents to healthcare providers and clinics.
Paents, clinical sta, and hospital IT sta do not require any special training, and do not need to congure
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