User's Manual

Use the correct suture sleeve (when needed) for each lead, to immobilize the lead and protect
it against damage from ligatures.
The defibrillator can undergo a short-circuit if the anode and cathode are not adequately
separated.In this case, the shock is aborted and a warning will indicate that a short circuit
(shock impedance < 20 ohms) was detected during the last shock. The device may be
damaged compromising ability to provide shock therapy.
Do not kink leads. Kinking leads may cause additional stress on the leads, possibly resulting
in lead fracture.
Do not insert a lead connector pin into the connector block without first visually verifying that
the setscrews are sufficiently retracted. Do not tighten the setscrews unless a lead connector
pin is inserted because it could damage the connector block.
Lead electrodes in contact during a cardioversion or defibrillation therapy will cause current
to bypass the heart, possibly damaging the ICD and the leads. While the ICD is connected to
the leads, make sure that the metal portions of any electrodes do not touch each other.
If a pacing lead is abandoned rather than removed, it must be capped to ensure that it is not
a pathway for currents to or from the heart.
If a thoracotomy is required to place epicardial patches, it should be done during a separate
procedure to reduce the risk of morbidity and mortality.
Do not place the patch lead over nerve tissue as this may cause nerve damage.
Place the patch lead with the conducting coil side facing the heart to ensure delivery of energy
to the heart.
Place the sutures well outside the coil of the patch lead or in the area between the coils to
avoid possible coil fracture.
If countershock is unsuccessful using external paddles, adjust the external paddle position
(e.g., anterior-lateral to anterior-posterior) and be sure that the external paddle is not
positioned over the patch.
Do not fold, alter, or remove any portion of the patch as it may compromise electrode function
or longevity.
If a header port is unused on the generator, the port must be plugged to protect the generator.
GENERATOR EXPLANT AND DISPOSAL
Interrogate the device, and program shock therapy off prior to explanting, cleaning or shipping
the device to prevent unwanted shocks.
Return all explanted generators and leads to the manufacturer.
Never incinerate the device due to the potential for explosion. The device must be explanted
before cremation.
4.5.
4. WARNINGS AND PRECAUTIONS
SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 15