User Manual

10. PHYSICIAN GUIDELINES
10. PHYSICIAN GUIDELINES
10.1. PHYSICIAN TRAINING
Physicians should be familiar with sterile pulse generator and left ventricular pacing lead
implant procedures. They must apply these procedures according to professional medical
training and experience.
Physicians should be familiar with follow-up evaluation and management of patients with an
implantable defibrillator (or referral to such a physician).
This training guideline for implantation and follow-up of ICD and CRT-D devices comes from
the Heart Rhythm Society to provide standards for hospital credentialing bodies to help
ensure appropriate patient care and lead to improved patient outcomes. The following is a
summary of requirements for an alternate training pathway for ICD and CRT-D
implantations
(1)
:
─ Documentation of current experience: 35 pacemaker implantations per year and 100
implantations over the prior 3 years
─ Proctored ICD implantation experience: 10 Implantations, 5 Revisions
─ Proctored CRT-D implantation experience: 5 implantations
─ Completion of didactic course and/or IBHRE® ExAM
─ Monitoring of patient outcomes and complication rates
─ Established patient follow-up
─ Maintenance of competence: 10 ICD and CRT-D procedures per year, 20 patients per
year in follow-up
(1)
Please consult full text of both publications for details. 2004 Heart Rhythm Society Clinical
Competency Statement and the 2005 Addendum on Training Pathways for Implantation of
Cardioverter Defibrillators and Cardiac Resynchronization Devices. Heart Rhythm (2004) 3,
371-375; Heart Rhythm.
10.2. DIRECTIONS FOR USE
ICD operating characteristics should be verified at the time of implantation and recorded in
the patient file. Complete the Patient Registration Form and return it to Sorin, as it provides
necessary information for warranty purposes and patient tracking.
Additional programming instructions can be found by accessing Online Help (click the “?” on
the screen) on the Sorin dedicated programmer. Paper copies of Online Help can be
obtained by contacting your Sorin representative.
10.3. MAINTAINING DEVICE QUALITY
This device is FOR SINGLE USE ONLY. Do not resterilize and reimplant explanted ICDs.
Do not implant the device when:
─ It has been dropped on a hard surface because this could have damaged pulse
generator components.
─ Its sterility indicator within the inner package is not green, because it might not have
been sterilized.
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SORIN – INTENSIA SonR CRT-D 184 – U150A