User's Manual

Program device parameters such as sensitivity threshold and VT and VF detection intervals
as specified in the device manuals.
Lead System:
Do not use a lead system other than those with demonstrated compatibility because
undersensing cardiac activity and failure to deliver necessary therapy may result.
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.
In the event of a warning on a low shock impedance, and after lead replacement or
reconnection: it is recommended to check the system integrity (sensing and pacing thresholds
and the impedance of the shock electrodes)
It is recommended that a safety 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.
LEAD EVALUATION AND LEAD CONNECTION
PLATINIUM 4LV SonR CRT-D 1844 has one DF4, one IS4, and one SonR connector ports.
The SonR connector port has been specifically designed by Sorin to accept three connections
(tripolar). The two distal connections respect the same dimensions as the IS-1 standard, and
an additional proximal connection allows to collect the SonR signal.
The SonR port accepts either a conventional atrial lead (without SonR capability) or a SonR
atrial lead (bipolar pacing/sensing and SonR capability).
IS-1 refers to the international standard whereby leads and generators from different
manufacturers are assured a basic fit (ISO 5841-3:2013).
DF4 and IS4 refer to the international standard for Four-pole connector systems for
implantable cardiac rhythm management devices (ISO 27186:2010).
Use only DF4-LLHH or DF4-LLHO standard lead connector types according to ISO
27186:2010.
Use only IS4-LLLL standard lead connector type according to ISO 27186:2010.
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 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.
4.4.
4. WARNINGS AND PRECAUTIONS
14 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A