Renamic - BIOTRONIK USA - News

4Indications and Contraindications for UseNote: Federal (USA) law restricts this device to sale by, or onthe order of, a physician.Indications for UseThe Renamic programmer is indicated for use with BIOTRONIKpacemakers and defibrillators. Therefore, the indications foruse for the specific implantable devices are applicable.Intended UseRenamic provides communication with the implantable pulsegenerator or ICD during the implantation procedure or followups.Renamic is intended to be used for the following tasks:• Conduct sensing, pacing threshold, and impedance tests• Interrogate data of the implanted device, such asprogram parameters, recorded statistical data, episodes,as well as real-time IEGMs• Display, printout, save and export data of the implanteddevice for analysis and reporting purposes• Transfer parameters to the implanted deviceThe Renamic programmer with PSA module is intended to beused for the following tasks:• Evaluation of the position and integrity of leads• Determination of appropriate pacing parameters for theimplanted deviceFor this intended purpose, the device provides the followingmeasurement/diagnostic functions:• For the sensing of intrinsic cardiac events:ооP/R wave amplitudes and slew rateооRates (PP, PR interval)ооIntrinsic AV delay (PR interval)ооConduction times (antegrade, retrograde)