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General| Device Type | Implantable Cardioverter Defibrillator (ICD) |
|---|---|
| Manufacturer | BIOTRONIK |
| Model | Enitra 6 DR-T |
| Programmability | Yes |
| Therapy Options | Anti-tachycardia pacing (ATP), Cardioversion, Defibrillation, Bradycardia pacing |
| Battery Longevity | Up to 10 years |
| MRI Compatibility | MR conditional |
| Communication | Telemetry |
| Lead Compatibility | BIOTRONIK Linox and other compatible leads |
| Battery Type | Lithium silver vanadium oxide |
Details the intended use of the Enitra pacemaker family for bradycardia arrhythmia indications and symptomatic therapy.
Explains BIOTRONIK's standardized lead connections (IS-1, IS-1/IS4) and compatibility notes.
Explains telemetric communication and programmer functions for device interaction.
Describes the therapy management system, data transmission, evaluation, and physician notification.
Covers auto-initialization, data storage, impedance measurements, and IEGM display with markers.
Explains sensing (P/R wave amplitudes, sensitivity adaptation) and pacing thresholds (capture control).
Details functions for resynchronizing ventricles, Capture Control, and pacing polarities for HF QP devices.
Details automatic data transmission to transmitter and initiated test messages for medical information.
Warns that cardiac electrotherapy requires special operating conditions and precautionary measures.
Lists possible technical failures: lead dislodgement, fracture, insulation defects, component failures, battery depletion.
Discusses device sensitivity to EMI, BIOTRONIK's design minimizing it, and potential effects like inhibition or triggering.
Lists procedures to avoid that may harm the patient or damage the device, like ultrasound or nerve stimulation.
Discusses risks from external electrical currents, diathermic procedures, and lithotripsy, requiring precautions.
Warns against radiation therapy due to device damage and impaired safety, requiring risk/benefit analysis and specific measures.
Warns against MRI due to high frequency fields and magnetic flux density, detailing potential damage and patient warming.
Lists required parts for implantation according to EC Directive 90/385/EEC.
Covers required parts, defibrillator readiness, device unpacking, and initial inspection.
Explains connecting leads, programming head use, telemetry, and auto-initialization.
Lists programming precautions, telemetry interruption warnings, and parameter setting guidelines.
Discusses power consumption, service time, Home Monitoring impact, and magnet response.
Outlines follow-up intervals, programmer use, and Home Monitoring support.
Defines ERI and EOS statuses, activation, display, rate changes, and deactivated functions.
Details pulse amplitude, pulse width, and sensitivity parameters for A/RV/LV.
Lists modes valid for ProMRI devices: MRI program (ON/OFF/AUTO), expiration date, and MRI mode (OFF/D00/A00 etc.).
