User's Manual

32 – US-ENGLISH
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 CRT-D system includes the model 9770 ICD
device and programming system. The programming system includes
the Sorin CRM Dedicated programmer with the SMARTVIEW
programming software connected to a CPR3 programming head. The
programming system is configured and furnished by Sorin CRM.
The PARADYM RF SonR CRT-D 9770 can serves as a defibrillation
electrode (active housing) with a total surface area of 76 cm².