User's Manual

34 – US-ENGLISH
10. PHYSICIAN GUIDELINES
10.1. PHYSICIAN TRAINING
Physicians should be familiar with sterile pulse generator implant
procedure and familiar with follow-up evaluation and management of
patients with an implantable defibrillator (or referral to such a physician).
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 CRM, 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 CRM dedicated
programmer. Paper copies of Online Help can be obtained by
contacting your Sorin CRM 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.
 Its storage package has been pierced or altered, because this
could have rendered it non-sterile.
 It has been stored or transported outside the environmental
temperature limits: 32 °F (0 °C) to 122 °F (50 °C) as an electrical
reset condition may occur.