User Manual

10. PHYSICIAN GUIDELINES
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, 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.
─ 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.
─ "Use Before" date has expired, because this can adversely affect pulse generator
longevity or sterility.
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SORIN – INTENSIA VR 124 – U153A