Device Dossier

Renamic Neo - Cardiac pulse generator programmer

Device Dossier for Renamic Neo - Cardiac pulse generator programmer (Cardiac pulse generator programmer, Class III, sponsor Biotronik). ARTG record,…

Intended purpose

The programmer provides communication with BIOTRONIK implantable pacemakers, ICDs, or implantable cardiac monitors (ICMs) during the implantation procedure or patient follow-up. The programmer is intended to enable the intended use of the implantable products by supplying the user interface to the device functions. Therefore, the programmer is used: • to verify and optimize the therapy delivered by the devices. • to support diagnosis of the patient status through data delivered by the devices. The PSA (pacing system analyzer) of the programmer supports lead implantations during the implantation procedure. Therefore, the PSA is used: • to support lead implantations with intraoperative measurements of electrophysiological parameters.

Functional description

Renamic Neo is a portable programmer and monitoring device with an integrated pacing system analyser. Can be custom-equipped with a cellular stick/mobile internet adapter. It displays surface ECGs and intracardiac derivations (IEGMs), stores parameters; records ECG/ IEGM. Components are: Renamic Neo programmer incl. NEO (software), stylus, ECG Patient Cable with electrode clips and Power cord/brick. External printer can be connected to print current parameter settings/recorded statistical data.

TGA Public Summary