St. Jude Medical Quadra Assura User Manual

Ellipse™
Fortify Assura™
Tiered-therapy Cardioverter/Defibrillator
Quadra Assura™, Quadra Assura MP™
Unify Assura™
Cardiac Resynchronization Device, Tiered-therapy Cardioverter/Defibrillator

St. Jude Medical Quadra Assura Specifications

General

Brand	St. Jude Medical
Model	Quadra Assura
Category	Medical Equipment
Language	English

Summary

Device Description

Indications and Usage

MR Conditional System

Describes the conditional safety of MR Conditional devices for use in MRI environments according to specific instructions.

Contraindications

Warnings and Precautions

Magnetic Resonance Imaging (MRI)

Sterilization, Storage and Handling

Follow-up Testing

Implantation and Device Programming

Pulse Generator Explant and Disposal

Environmental and Medical Therapy Hazards

Hospital and Medical Environments

Specific hazards in hospital and medical settings, including electrosurgical cautery and its effects.

Home and Occupational Environments

Electronic Article Surveillance, Security and Logistical Systems, and Metal Detectors

Cellular Phones

Potential Adverse Events

Clinician Use Information

Physician Training

Maintaining Device Effectiveness

Device Storage

Detailed instructions and conditions for storing the pulse generator, including temperature limits and handling precautions.

Sterilization Instructions

Directions for Use

Radiopaque Identification