sorin Platinum VR 1210

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Summary

General Description

Device Indications

Outlines patient conditions for which the device is indicated.

Device Contraindications

Lists patient conditions where implantation is not recommended.

Warnings and Precautions

Medical Environment Risks

Details risks from external electromagnetic interference and medical procedures.

Sterilization, Storage, Handling

Guidelines for device integrity, storage conditions, and handling.

Adverse Events

Defender Study Safety Data

Presents adverse event data from the Defender study applicable to PLATINIUM VR.

Clinical Studies

Study Population and Complication Rate

Summarizes study participant numbers and complication-free rate.

Patient Selection and Treatment

Individualization of Treatment

Discusses exercise stress testing, EP testing, and drug therapy considerations.

Specific Patient Populations

Addresses considerations for pregnancy, nursing mothers, pediatric, geriatric, and disabled patients.

Physician Guidelines

Physician Training and Use

Emphasizes physician training and correct device usage.

Device Description

Device Features and Connectors

Describes the device's capabilities, algorithms, and connector types.

Implant Procedure

Implant Equipment

Lists required and optional equipment for device implantation.

Pre-Implantation Steps

Covers package check, interrogation, and preparation before surgery.

Device Placement and Lead Connection

Details proper placement and connection of the device and leads.

Main Functions

Automatic Lead Measurements

Describes automatic lead impedance, coil impedance, and sensing measurements.

Tachyarrhythmia Management

Covers algorithms for discrimination and fast VT treatment.

Remote Monitoring Function

Explains RF wireless capabilities for remote patient data transmission.

Patient Follow-Up

Follow-Up Recommendations

Guidelines for patient discharge and subsequent follow-up visits.

Recommended Replacement Time (RRT)

Explains RRT, its implications, and remaining device function.

Electrical Characteristics

Shock Energy and Voltage

Table relating stored energy, voltage, and delivered energy at 50 ohm load.

Battery Specifications

Details manufacturer, type, model, and capacity of the battery.

Longevity Projections

Shows projected device longevity under various usage conditions.

Programmable Parameters

Antibradycardia Pacing Parameters

Lists programmable parameters for managing bradycardia.

Tachyarrhythmia Detection

Details detection criteria and zones for ventricular tachyarrhythmias.

Tachyarrhythmia Therapies

Describes programmable ATP and shock therapies for VT/VF.

Explanation of Symbols

Product Labeling Symbols

Defines symbols used on product labels and packaging.