BIOTRONIK SE and KG TACH70 implantable cardioverter defibrillator User Manual

BIOTRONIK SE & Co. KG implantable cardioverter defibrillator

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15_[TACH70] UserMan

1Inventra 7Iperia 5/7 Itrevia 5/7 VR-T, VR-T DX DR-T HF-T, HF-T QPICD-Families Tachyarrhythmia Therapy Cardiac Resynchronization Therapy Technical Manual Draft Subject to completion and modification1 Product DescriptionIntended Medical UseIntended useInventra/Iperia/Itrevia are parts of a familiy of implantable cardioverter-defibrillators (ICDs). Primary objective of the therapy is to prevent sudden cardiac death. Further-more, the device is capable of treating bradycardia arrhythmias and cardiac resynchro-nization 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) through antitachycardia pacing (ATP); in case of ineffective ATP or hemodynamically not tolerated VT, with shock delivery •Cardiac resynchronization through multisite ventricular pacing (triple-chamber devices)•Compensation of bradycardia through ventricular (single-chamber devices) or AV sequential pacing (DX, dual and triple-chamber devices)Diagnosis and therapy formsThe device monitors the heart rhythm and automatically detects and terminates cardiac arrest resulting from ventricular tachyarrhythmia. All major therapeutic approaches from the field of cardiology and electrophysiology are included. BIOTRONIK Home Monitoring® enables physicians to perform therapy management at any time.Required expertiseIn addition to having basic medical knowledge, the user must be thoroughly familiar with the operation and the operation conditions of a device system.•Only qualified medical specialists having this special knowledge required are permitted to use implantable devices.•If users do not possess this knowledge, they must be trained accordingly.
2IndicationsInventra/Iperia/Itrevia can treat life-threatening ventricular arrhythmias with anti-tachycardia pacing and defibrillation.Generally approved differential diagnostics methods, indications, and recommenda-tions for ICD therapy apply to BIOTRONIK devices. See the guidelines of cardiology associations for guidance. We recommend observing the indications published by the German Cardiac Society (Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung) and the ESC (European Society of Cardiology). This also applies to the guidelines published by the Heart Rhythm Society (HRS), the American College of Cardiology (ACC), the American Heart Association (AHA), and other national cardiology associations.Single-chamber and dual-chamberSingle-chamber and dual-chamber ICDs are indicated for patients with the following risk:•Sudden cardiac death caused by ventricular arrhythmiasTriple-chamberTriple-chamber ICDs are indicated for patients with the following risks:•Sudden cardiac death caused by ventricular arrhythmias•Congestive heart failure with ventricular asynchronyContraindicationsKnown contraindications:•Tachyarrhythmia caused by temporary or reversible irritation, e.g. poisoning, elec-trolyte imbalance, hypoxia, sepsis or acute myocardial infarction•Such frequent VT or VF that the therapies would cause an unacceptably rapid depletion of the device batteries•VT with few or without clinically relevant symptoms•VT or VF treatable by surgery•Concomitant diseases that would substantially limit a positive prognosis•Accelerated idioventricular rhythmSystem OverviewDevice familyThis device families consist of several device types with different lead connections: DF-1/IS-1, DF4/IS-1 or DF4/IS4/IS-1:single-chamber: VR-T and VR-T DX (only devices with a DF-1/IS-1 connection)dual-chamber: DR-Ttriple-chamber: HF-T and HF-T QP (only devices with a DF4 connection)All devices include BIOTRONIK Home Monitoring. Not all device types are available in every country.DeviceThe device's housing is made of biocompatible titanium, welded from outside and thus hermetically sealed. The ellipsoid shape facilitates implantation in the pectoral muscle area. The connections for bipolar pacing and sensing (and unipolar connections for the triple-chamber device) as well as for shock delivery are found in the device header. The housing serves as a potential antipole during shock delivery or in the case of unipolar lead configuration.DF-1/IS-1 or DF4/IS-1 or DF4/IS4BIOTRONIK provides ICDs with headers for different standardized lead connections: DF-1/IS-1, DF4/IS-1 and DF4/IS4.DF-1/IS-1 lead connectionThe device labeling provides information pertaining to possible lead connections depending on the device type and pertaining to connection assignment: Note: The device type DX can only be connected using a DF-1/IS-1 connector.The device type HF QP can only be connected using a DF4/IS-1 or DF4/IS4 connector.VR DX DR HFDF-1 RVDF-1SVCIS-1RVDF-1 RVDF-1SVCIS-1RAIS-1RVDF-1 RVDF-1SVCIS-1RAIS-1RVDF-1 RVDF-1SVC IS-1RAIS-1RVIS-1LV
3DF4/IS-1 lead connectionThe device labeling provides information pertaining to possible lead connections depending on the device type and pertaining to connection assignment: DF4/IS4/IS-1 lead connectionThe device labeling provides information pertaining to possible lead connections depending on the device type and pertaining to connection assignment: LeadsBIOTRONIK leads are sheathed with biocompatible silicone. They can be flexibly maneuvered, are stable long-term, and are equipped for active or passive fixation. They are implanted using a lead introducer set. Some leads are coated with polyurethane which is known to increase the sliding properties for the lead. Leads with steroids reduce inflammatory processes. The fractal design of the electrodes provides for low pacing thresholds. BIOTRONIK provides adapters to connect already implanted leads to new devices.TelemetryTelemetric communication between the device and the programmer can be carried out following initialization either by applying the programming head (PGH) to the device or by using radio frequency (RF) telemetry in the programmer. BIOTRONIK calls this func-tion SafeSync®.Connector port Lead connectorConfiguration Implantation site Device typeRV DF-1 Shock coil Right ventricle VR, DX, DR, HFSVC DF-1 Shock coil Superior vena cavaVR, DX, DR, HFRA IS-1 Bipolar Atrium DX, DR, HF(R)V IS-1 Bipolar (Right) ventricle VR, DX, DR, HFLV IS-1 Unipolar, bipolar Left ventricle HFVR DR HFConnector port Lead connectorConfiguration Implantation site Device typeRA IS-1 Bipolar Atrium DR, HFLV IS-1 Unipolar, bipolar Left ventricle HFRV, SVC DF4 Bipolar and shock Right ventricle VR, DR, HFNote: The device's DF4 connector port may only be used for connecting leads with a DF4 connector that conform to ISO 27186.DF4-LLHH RV DF4-LLHH RVIS-1RADF4-LLHH RVIS-1RAIS-1LVHF QPConnector port Lead connectorConfiguration Implantation site Device typeRA IS-1 Bipolar Atrium HF QPLV IS4 Unipolar, bipolar Left ventricle HF QPRV, SVC DF4 Bipolar and shock Right ventricle HF QPNote: The device's DF4/IS4 connector port may only be used for connecting leads with a DF4/IS4 connector that conform to ISO 27186.DF4-LLHH RVIS4-LLLLRAIS-1LV
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Document ID2250181
Application IDKOpdIPWOj5+petoCs3PWmg==
Document Description15_[TACH70] UserMan
Short Term ConfidentialNo
Permanent ConfidentialNo
SupercedeNo
Document TypeUser Manual
Display FormatAdobe Acrobat PDF - pdf
Filesize33.58kB (419785 bits)
Date Submitted2014-04-24 00:00:00
Date Available2014-10-21 00:00:00
Creation Date2013-07-26 14:26:13
Producing SoftwareAcrobat Distiller 9.0.0 (Windows)
Document Lastmod2014-04-08 13:49:26
Document Titleuntitled
Document CreatorFrameMaker 8.0
FCC ID Filing: QRITACH70

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