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St. Jude Medical CD3369-40QC User Manual

St. Jude Medical CD3369-40QC
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 CD3369-40QC Specifications

General IconGeneral
Device TypeCardiac Lead
Model NumberCD3369-40QC
ManufacturerSt. Jude Medical (now Abbott)
Length40 cm
Connector TypeIS-1
PolarityBipolar
Fixation MechanismActive
SterilizationEthylene Oxide

Summary

Indications and Usage

MR Conditional System

Contraindications

Warnings and Precautions

Resuscitation Availability

Ensure availability of external defibrillator and skilled personnel for testing.

Shock Handling Precautions

Disable therapies and exercise caution when handling leads to prevent shocks.

Magnetic Resonance Imaging (MRI)

MR Conditional Devices

Explains MRI conditional status and testing for MR conditional systems.

Sterilization, Storage and Handling

Resterilization Policy

Do not resterilize or re-implant explanted pulse generators.

Follow-up Testing

Implantation and Device Programming

Pulse Generator Explant and Disposal

Environmental and Medical Therapy Hazards

Hospital and Medical Environments

Electrosurgical Cautery

Risks associated with electrosurgical cautery and how to mitigate them.

External Device Hazards

Potential Adverse Events

Clinician Use Information

Physician Training

Maintaining Device Effectiveness

Device Storage

Guidelines for storing the device to maintain its integrity and function.

Technical Support

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