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Table of Contents
- 1 Device Description
- 2 Warnings and Precautions
- 3 Follow up Testing
- 4 Pulse Generator Explant and Disposal
- 5 Environmental and Medical Therapy Hazards
- 6 Hospital and Medical Environments
- 7 Cellular Phones
- 8 Potential Adverse Events
- 9 Physician Training
- 10 Device Storage
- 11 Directions for Use
- 12 Technical Support
- 13 Additional Information
- Download this manual
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Table of Contents
Related Manuals for St. Jude Medical Ellipse DR
Summarization of Contents
Warnings and Precautions
Resuscitation Availability
Ensure external defibrillator and CPR personnel are available for device testing.
Lead System Compatibility
Use only compatible lead systems to avoid sensing issues and therapy failure.
Handling Precautions
Disable therapies or turn them off during implant, explant, or post-mortem procedures.
Sterilization, Storage and Handling
Storage Conditions
Store device in a clean area away from magnets and EMI, between 10° and 45°C.
Device Shelf Life
Do not implant devices after the 'use before' date due to reduced battery longevity.
Implantation and Device Programming
Magnet Usage Guidelines
Do not position magnet over device unless programmed to ignore it.
Optimal Implant Depth
Implant pulse generator no deeper than 5 cm for reliable data transmission.
Pulse Generator Explant and Disposal
Explant Procedure
Interrogate device and turn off therapies before explanting.
Disposal Requirements
Never incinerate the device due to explosion risk; explant before cremation.
Environmental and Medical Therapy Hazards
Electromagnetic Interference (EMI)
Patients should avoid devices generating strong EMI to prevent malfunction.
Electrosurgical Cautery
Keep current path and groundplate away from generator during cautery.
Maintaining Device Effectiveness
Device Storage
Store device in sterile tray, avoid dropping, damage, or temperature limits.
Directions for Use
Verify operating characteristics at implantation and record in patient file.
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