User Manual

4. WARNINGS AND PRECAUTIONS
In situations where an ICD and a pacemaker are implanted in the same patient, interaction
testing should be completed. If the interaction between the ICD and the pacemaker cannot
be resolved through repositioning of the leads or reprogramming of either the pacemaker or
the ICD, the pacemaker should not be implanted (or should be explanted if previously
implanted).
Failure to properly insert the torque screwdriver into the perforation at an angle
perpendicular to the connector receptacle may result in damage to the sealing system and
its self-sealing properties.
It is recommended that a security margin of at least 10 J be demonstrated between the
effective shock energy and maximum programmable energy. Carefully confirm that true
ventricular fibrillation has been induced because the DFT for ventricular tachycardia or flutter
may be lower.
The defibrillator should be implanted with the engraved side facing outwards in order to
facilitate telemetric communication with the programming head and to display the
radiographic identification correctly.
*: corresponds to ERI (Elective Replacement Indicator) previously used.
4.4. LEAD EVALUATION AND LEAD CONNECTION
INTENSIA VR 124 has one DF-4 connector port.
DF-4 refers to the international standard for defibrillation lead connectors (ISO 27186:2010).
Do not use the device with leads which have not been positively tested.
Do not tie a ligature directly to the lead body, tie it too tightly, or otherwise create excessive
strain at the insertion site as this may damage the lead. Use the lead stabilizer to secure the
lead lateral to the venous entry site.
Do not immerse the lead in mineral oil, silicone oil, or any other liquid.
Do not grip the lead with surgical instruments.
Do not use excessive force or surgical instruments to insert a stylet into a lead.
Use ventricular transvenous leads with caution in patients with either a mechanical or
bioprosthetic tricuspid valvular prosthesis.
Use the correct suture sleeve (when needed) , to immobilize the lead and protect it against
damage from ligatures.
Never implant the system with a lead system that has a measured shock impedance of less
than 30 ohms. A protection circuit in the defibrillator prevents shock delivery when
impedance is too low. If the shock impedance is less than 30 ohms, reposition the lead
system to allow a greater distance between the electrodes.
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 lead. While the ICD is connected
to the lead, 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.
SORIN – INTENSIA VR 124 – U153A
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