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St. Jude Medical CD1357-40C User Manual

St. Jude Medical CD1357-40C
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 CD1357-40C Specifications

General IconGeneral
ModelCD1357-40C
ManufacturerSt. Jude Medical
CategoryMedical Equipment
TypeImplantable Cardioverter Defibrillator (ICD)
Battery TypeLithium Silver Vanadium Oxide
MRI ConditionalYes
TherapyCardioversion, Defibrillation
ProgrammabilityYes

Summary

Indications and Usage

MR Conditional System

An MR Conditional device is conditionally safe for use in the MRI environment when used in a complete system.

Contraindications and Warnings

Contraindications

Contraindications for use of the pulse generator system include ventricular tachyarrhythmias from transient or correctable factors.

Key Warnings and Precautions

Covers resuscitation availability, lead systems, shock hazards, and pacemaker use.

Magnetic Resonance Imaging (MRI) Considerations

MR Conditional and Untested Devices

Discusses MR Conditional system safety and the status of MR Untested devices.

Sterilization, Storage, and Handling

Prohibitions and Storage Guidelines

Covers resterilization prohibition, implant date, package integrity, and storage conditions.

Temperature, Testing, and Implantation

Temperature Equilibration and Testing

Allow temperature equilibration and ensure testing personnel are present.

Explant, Disposal, and Environmental Hazards

Explant Procedures and Disposal Warnings

Covers pre-explant steps, return policy, and disposal methods.

External Defibrillation and Therapy Risks

External Defibrillation and Radiation Safety

Precautions for external defibrillation, high radiation, lithotripsy, and diathermy.

TENS, RF Ablation, and RF Frequencies

Airport Security, Cellular Phones, and Adverse Events

Potential Adverse Events Overview

Lists common adverse events associated with the system.

Adverse Events: System Complications

Adverse Events: Respiratory and Psychological

Electromagnetic Compatibility and Physician Training

Device Effectiveness: Storage and Sterilization

Sterilization Instructions

Do not resterilize using autoclave, gamma-irradiation, organic agents, or ultrasonic cleaners.

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