User's Manual

US-ENGLISH – 35
 "Use Before" date has expired, because this can adversely affect
pulse generator longevity or sterility.
11. PATIENT INFORMATION
Information for the patient is available in the patient booklet,
contained in the outer storage package. Additional copies can be
obtained by contacting your Sorin CRM representative or on the
Sorin CRM's web site: http://www.sorin.com.
This information should be given to each patient with their first ICD
and offered to the patient on each return visit or as deemed
appropriate.
12. HOW SUPPLIED
12.1. STERILITY
The PARADYM RF defibrillators are supplied one per package in a
sterile package.
12.2. WARRANTY AND REPLACEMENT POLICY
Sorin CRM warrants its defibrillators. Refer to the section "Warranty"
for additional information. Please see the following labelling sections
for information concerning the performance of this device:
Indications, Contraindications, Warnings and Precautions, and
Adverse Events.
13. DEVICE DESCRIPTION
The PARADYM RF DR system includes the model 9550 ICD device
and programming system. The programming system includes the
Sorin CRM Orchestra Plus programmer with SMARTVIEW
programming software connected to a CPR3 programming head. The
programming system is configured and furnished by Sorin CRM.