User Manual

4. WARNINGS AND PRECAUTIONS
protection shield. ATP and shock therapies should be disabled during exposure and proper
device function should be checked regularly afterwards. Resulting damage may not be
immediately detectable. If irradiation of tissues close to the implantation site is necessary, it
is recommended that the cardiac defibrillator be moved. As a safety measure, an external
defibrillator should be immediately available.
Lithotripsy:
Lithotripsy may permanently damage the device if it is at the focal point of the lithotripsy
beam. If lithotripsy must be used, keep the defibrillator at least 2.5 to 5 cm (1-2 inches) away
from the focal point of the lithotripsy beam.
Diagnostic ultrasound (echography):
The defibrillator is not affected by ultrasound imaging devices.
Scales with body fat monitors and electronic muscle stimulators:
A patient with an implanted INTENSIA SonR CRT-D 184 should not use these devices.
4.2. STERILIZATION, STORAGE AND HANDLING
Resterilization:
Do not resterilize and re-implant explanted ICDs.
"Use Before" Date:
A "Use Before" date is printed on the outer storage package and on the sterile package. Do
not implant the device after this date because the battery may have reduced longevity and
sterility may be affected. It should be returned to Sorin.
If Package is damaged:
Do not use the device or accessories if the packaging is wet, punctured, opened or
damaged because the integrity of the sterile packaging may be compromised. Return the
device to the manufacturer.
Device Storage:
Store the device in a clean area, away from magnets, kits containing magnets, and sources
of electromagnetic interference to avoid device damage. Store the device between 0 - 50 °C
(32 - 122 °F). Temperatures outside the specified range may damage the device.
Equilibration:
Allow the device to reach room temperature before programming or implanting the device
because rapid temperature changes may affect initial device function.
4.3. IMPLANTATION AND DEVICE PROGRAMMING
Use only a Sorin programmer to communicate with the device.
Do not inadvertently position any magnet over the ICD; this suspends tachyarrhythmia
detection and treatment.
Replace the device when the RRT (Recommended Replacement Time*) point (defined by a
battery voltage of 2.66 ± 0.01 V or a magnet rate lower than or equal to 80 bpm) is reached.
Program device parameters such as sensitivity threshold and VT and VF detection intervals
as specified in the device manuals.
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SORIN – INTENSIA SonR CRT-D 184 – U150A