Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Biotronik Australia Pty Ltd
AIMD
Biotronik SE & Co KG Woermannkehre 1, Berlin, D-12359 Germany
47270 - Biventricular pacemaker/defibrillator
A triple chamber rate adaptive ICD, with IS4 port connecting a quadripolar LV lead, Home Monitoring functions, max. shock of 40J and DF4/IS4/IS-1 connector. Biocompatible titanium housing is hermetically sealed and serves as a potential antipole during shock delivery or in the case of unipolar lead configuration. Ellipsoid shape facilitates implanting in the pectoral muscle area. Connections for bipolar pacing, sensing, unipolar connections and shock delivery are in the header. MR conditional. Rivacor 7 HF-T QP belongs to a family of implantable cardioverter-defibrillators (ICDs). The primary objective of the therapy is to prevent sudden cardiac death. Furthermore, the device is capable of treating bradycardia arrhythmias and cardiac resynchronization therapy with multisite ventricular pacing. The implantation of an ICD is a symptomatic therapy with the following objectives: ?Termination of spontaneous ventricular fibrillation (VF) through shock delivery ?Termination of spontaneous ventricular tachycardia (VT
A
2019-03-18
Rivacor ProMRI Family of ICDs and CRT-Ds Technical Manual ® © 2019 BIOTRONIK, Inc., All rights reserved. CAUTION Federal (U.S.A.) law restricts this device to sale by, or on the order of, a physician. Rivacor ProMRI ® Family of ICDs and CRT-Ds Technical Manual Contents Chapter 1: General 1 1.1 System Description 1 1.2 Indications for Use 3 1.3 Contraindications 3 1.4 Warnings and Precautions 3 1.4.1 Sterilization, Storage, and Handling 4 1.4.2 Device Implantation and Programming 5 1.4.3 Lead Evaluation and Connection 6 1.4.4 Follow‑up Testing 7 1.4.5 Pulse Generator Explant and Disposal 7 1.4.6 Hospital and Medical Hazards 7 1.4.7 Home and Occupational Hazards 8 1.4.8 Cellular Phones 8 1.4.9 Electronic Article Surveillance (EAS) 9 1.4.10 Home Appliances 9 1.4.11 Home Monitoring 9 1.5 Potential/Observed Effects of the Device on Health 10 1.5.1 Potential Adverse Events 10 1.6 Patient Selection and Treatment 11 1.6.1 Individualization of Treatment 11 1.6.2 Specific Patient Populations 12 1.7 Patient Counseling Information 12 1.8 Evaluating Prospective CRT‑D/ICD Patients 12 Chapter 2: Programmer 15 2.1 Device Programming 16 2.2 Master Switch Behavior 16 2.2.1 Enabled 16 2.2.2 Disabled 17 2.2.3 Temporarily Active 17 2.2.4 Temporarily Inactive 17 2.2.5 Pending 18 Rivacor ProMRI ® Family of ICDs and CRT-Ds Technical Manual 2.3 RF Telemetry 18 2.3.1 Establishing RF Telemetry Contact 19 2.3.2 Economy Mode 20 2.3.3 Ending a Follow‑up Session 20 2.3.4 Switch between RF and Wand 21 2.3.5 Power Consumption Consideration 21 2.4 Programmer Functions 22 2.4.1 Far‑Field IEGM for Threshold Testing (Leadless ECG) 22 2.4.2 Real‑time IEGM Transmission 22 2.4.3 Additional Programmer Functions 25 2.4.3.1 Speed 26 2.4.3.2 ECG 26 2.4.3.3 Color scheme 26 2.4.3.4 AC Frequency 26 2.4.3.5 Gain 26 2.4.3.6 Overwrite / Continuous 26 2.4.3.7 Standard 26 2.4.3.8 Stores 26 2.4.4 Preferences 26 2.4.4.1 Follow‑up Preferences 26 2.4.4.2 Test Preferences 27 2.4.4.3 Print Preferences 28 2.4.4.4 System Preferences 30 2.4.4.5 Connectivity read_full_document