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St. Jude Medical Unify Assura User Manual

St. Jude Medical Unify Assura
34 pages
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Ellipse™
Fortify Assura™
Tiered-therapy Cardioverter/Defibrillator
Quadra Assura™, Quadra Assura MP™
Unify Assura
Cardiac Resynchronization Device, Tiered-therapy Cardioverter/Defibrillator

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St. Jude Medical Unify Assura Specifications

General IconGeneral
Device TypeImplantable Cardioverter Defibrillator (ICD)
ManufacturerSt. Jude Medical (now Abbott)
ModelUnify Assura
TherapyAnti-tachycardia pacing (ATP), Defibrillation, Bradycardia pacing
Defibrillation EnergyUp to 40 Joules
Pacing ModesAAI, VVI, DDD, DDDR, VDD, VDDR
MRI CompatibilityMR Conditional (specific models and conditions apply)
Remote MonitoringMerlin.net Patient Care Network
Lead CompatibilitySt. Jude Medical/Abbott leads
Battery LongevityApproximately 5-7 years depending on usage

Summary

Device Description

Indications and Usage

MR Conditional System

Defines conditions for safe use of MR Conditional devices in MRI environments.

Contraindications

Warnings and Precautions

Resuscitation and Handling Safety

Ensures trained personnel for testing and advises on safe handling practices to prevent shocks.

System Compatibility and Interaction

Emphasizes using compatible leads and managing pacemaker interaction for optimal performance.

Magnetic Resonance Imaging (MRI)

Sterilization, Storage and Handling

Device Integrity and Storage Requirements

Covers checks for device integrity, storage conditions, and temperature equilibration before use.

Implantation and Device Programming

Pulse Generator Explant and Disposal

Details procedures for interrogating, disabling, and returning explanted pulse generators.

Environmental and Medical Therapy Hazards

Hospital Environment Hazards

Discusses risks from electrosurgical cautery and other medical equipment in hospital settings.

External Medical Procedures and Radiation Risks

Covers hazards from external defibrillation, radiation, lithotripsy, diathermy, and ultrasound therapy.

Home and Occupational Environments

Electromagnetic Interference Sources

Identifies sources of EMI like power lines, communication equipment, home, and industrial machinery.

Electronic Article Surveillance and Security Systems

Cellular Phones Compatibility

Potential Adverse Events

Clinician Use Information

Physician Training Requirements

Highlights the necessity for physicians to be trained in device implantation and patient follow-up.

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