Thoratec HeartMate III, Инструкция по эксплуатации

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5 Surgical Procedures
5-32 HeartMate III Left Ventricular Assist System Instructions for Use
• Prior to implanting an implantable cardiac defibrillator or implantable pacemaker in a
HeartMate III patient, the device to be implanted should be placed in close proximity to the
Pump (approximately 10 cm) and the telemetry verified. If a patient receives a HeartMate III
and has a previously implanted device that is found to be susceptible to this programming
interference, Thoratec Corporation recommends replacing the implantable cardiac
defibrillator device with one that is not prone to programming interference.
• The HeartMate III pump may cause interference with implantable cardiac defibrillators
(ICD). If electromagnetic interference occurs, it may lead to inappropriate ICD therapy. The
occurrence of electromagnetic interference with ICD sensing may require adjustment of
device sensitivity and/or repositioning the lead.
• Initial weaning of cardiopulmonary bypass should ensure a minimum of two liters per
minute (lpm) of blood flow to the Left Ventricular Assist Device to prevent air embolism.
Prolonged de-airing may be due to inadequate blood supply to the Left Ventricular Assist
Device or a leak in the sealed Outflow Graft or Inflow Cannula.
• Patients with mitral or aortic mechanical valves may be at added risk of accumulating
thrombi on the valve when supported with left ventricular assist devices.
• A sealed HeartMate III Outflow Graft must be used. A sealed HeartMate II Outflow Graft is
not appropriate for use with the HeartMate III LVAS.
• Do not trim or cut the bend relief of the sealed Outflow Graft or a sharp edge may result.
This sharp edge could damage the underlying graft material and cause blood loss.
WARNING ! (Continued)