User's Manual

US-ENGLISH – 25
8. PATIENT COUNSELLING INFORMATION
The physician should consider the following points in counselling the
patient about this device:
 Persons administering CPR may experience tingling on the
patient’s body surface when the patient’s ICD system delivers a
shock.
 Advise patients to carry Sorin CRM ID cards and/or ID bracelets
documenting their ICD system.
9. CONFORMANCE TO STANDARDS
This device was developed in conformance with all or parts of the
following standards:
 EN 45502-1: 1998 – Active implantable medical devices.
General requirements for safety, marking and information to be
provided by the manufacturer.
 EN 45502-2-1: 2003 - Active implantable medical devices.
Part 2-1: Particular requirements for active implantable medical
devices intended to treat bradyarrhythmia (cardiac pacemakers).
 EN 45502-2-2: 2008 – Active implantable medical devices.
Part 2-2: Particular requirements for active implantable medical
devices intended to treat tachyarrhythmia (includes implantable
defibrillators).
 ISO 5841-3: 2000 Low profile connectors (IS1) for implantable
pacemakers.
 ISO 11318 (DF-1): Cardiac defibrillator: connector assembly for
implantable defibrillators - Dimensional and test requirements,
August 2002.
 ANSI/AAMI PC69:2007 Active implantable Medical Devices -
Electromagnetic compatibility - EMC test protocols for implantable
cardiac pacemakers and implantable Cardioverter Defibrillators.