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General| Brand | St. Jude Medical |
|---|---|
| Model | Ellipse |
| Category | Medical Equipment |
| Language | English |
Ensure external defibrillator and skilled medical personnel are present for device testing.
Use only compatible lead systems to avoid undersensing or therapy failure.
Disable therapy during procedures when touching terminals to avoid shocks.
If using another pacemaker, ensure bipolar pacing reset and programming.
Conditionally safe for MRI use per specific instructions and system components.
'Untested' means device use in MRI environment is undetermined.
Do not resterilize explanted pulse generators.
Do not implant after 'use before' date due to battery longevity.
Do not use if packaging is compromised; return to St. Jude Medical.
Store in clean area away from EMI sources, between 10° and 45°C.
Allow device to reach room temp after cold storage before use.
TENS may interfere; place electrodes away from device/lead system.
Minimize RF ablation risks by turning off therapies, avoiding contact.
High-voltage lines may generate EMI interfering with generator operation.
Microwave/amateur transmitters may generate EMI interfering with operation.
Some appliances or tools can cause disturbances; avoid direct contact.
Welders, furnaces, motors, engines can produce EMI affecting operation.
Details critical storage conditions and handling requirements for device integrity.
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