Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
Abbott Medical Australia Pty Ltd
AIMD
St Jude Medical Cardiac Rhythm Management Division 15900 Valley View Court, Sylmar, California, 91342 United States Of America
35852 - Defibrillator, implantable, automatic
The Unify Assura CD3361-40C is a cardiac resynchronisation therapy device with RF telemetry and it monitors and regulates the patient?s heart rate by providing ventricular tachyarrhythmia therapy and Single Site Pacing. It features an IS-1/DF-1 device header and Parylene coating. The Unify Assura CD3361-40C is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Cardiac Resynchronization Therapy devices (CRT-Ds) are also intended to resynchronize the right and left ventricles in patients with congestive heart failure. Also AT/AF detection algorithm is indicated for detecting atrial tachyarrhythmias which have been found to be associated with an increased risk of stroke in elderly, hypertensive, pacemaker patients without prior history of AF.
A
2013-03-19
Merlin@home TM Transmitter Compatible Unify Assura ™ Cardiac Resynchronisation Therapy Defibrillator (CRT-D) Cardiac Resynchronisation Therapy (CRT) Devices Product Highlights ■ ■ Parylene coating for improved abrasion resistance ■ ■ DynamicTx ™ Over-Current Detection Algorithm automatically changes shock configurations to ensure delivery of high voltage therapy when high current is detected ■ ■ Cold Can programmability provides an additional RV-SVC Shock Configuration to decouple the can from the shocking vector parameters in cases of lead problems ■ ■ ShockGuard ™ technology with DecisionTx ™ programming designed to reduce inappropriate therapy and minimise the need for programming adjustments at implant ■ ■ SecureSense ™ RV lead noise discrimination detects sustained and short bursts of lead noise that would otherwise go unnoticed or potentially lead to one or more inappropriate shocks ■ ■ Far Field MD ™ morphology discrimination and Chamber Onset discrimination improve SVT and VT discrimination for reduced inappropriate therapies ■ ■ Antitachycardia pacing (ATP) while charging and prior to charging in the VF zone further extends the programming options for terminating tachyarrhythmias without a high-voltage shock ■ ■ Low Frequency Attenuation filter designed to enhance sensing performance and may reduce the possibility of oversensing T-waves ■ ■ Sense_Ability_ ™ feature provides flexibility to fine-tune programming around T-wave oversensing without decreasing sensitivity ■ ■ DF4 connector designed to streamline defibrillation connections into a single terminal pin and reduce the number of set screws ■ ■ Unique 40 J delivered energy safety shock option can provide a greater DFT safety margin ■ ■ DeFT Response ™ technology offers the most noninvasive options for managing high DFTs ■ ■ QHR ™ * chemistry battery provides greater capacity for enhanced longevity and improved charge time performance compared to previous SVO batteries ■ ■ Vibra Perskaitykite visą dokumentą
Ellipse™ Tiered-therapy Cardioverter/Defibrillator Fortify Assura™ Tiered-therapy Cardioverter/Defibrillator Quadra Assura™, Quadra Assura MP™ Cardiac Resynchronization Device, Tiered-therapy Cardioverter/Defibrillator Unify Assura™ Cardiac Resynchronization Device, Tiered-therapy Cardioverter/Defibrillator Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies. © 2015 St. Jude Medical, Inc. All Rights Reserved. 1 Device Description This manual describes the following St. Jude Medical™ pulse generators 1 : Table 1. Single-chamber pulse generator descriptions Name Model Number Description Connector Type Delivered Energy (approx.) MRI Status Fortify Assura VR CD1257-40 Single-chamber ICD with RF telemetry DF-1/IS-1 40 J Untested Fortify Assura VR CD1257-40Q Single-chamber ICD with RF telemetry DF4-LLHH 40 J Untested Fortify Assura VR CD1259-40 Single-chamber ICD with RF telemetry DF-1/IS-1 40 J Untested Fortify Assura VR CD1259-40Q Single-chamber ICD with RF telemetry DF4-LLHH 40 J Untested Fortify Assura VR CD1261-40 Single-chamber ICD with RF telemetry DF-1/IS-1 40 J Untested Fortify Assura VR CD1261-40Q Single-chamber ICD with RF telemetry DF4-LLHH 40 J Untested Ellipse VR CD1275-36 Single-chamber ICD with RF telemetry DF-1/IS-1 36 J Untested Ellipse VR CD1275-36Q Single-chamber ICD with RF telemetry DF4-LLHH 2 36 J Untested Ellipse VR CD1277-36 Single-chamber ICD with RF telemetry DF-1/IS-1 36 J Untested Ellipse VR CD1277-36Q Single-chamber ICD with RF telemetry DF4-LLHH 36 J Untested Ellipse VR CD1279-36 Single-chamber ICD with RF telemetry DF-1/IS-1 36 J Untested Ellipse VR CD1279-36Q Single-chamber ICD with RF telemetry DF4-LLHH 36 J Untested Ellipse VR CD1311-36Q Single-chamber ICD with RF telemetry DF4-LLHH 36 J Untested Ellipse VR CD1311-36 Single-chamber ICD with RF telemetry DF-1/IS-1 36 Perskaitykite visą dokumentą