User's Manual

28 – US-ENGLISH
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.
─ IEC 60601-1-2 (2007): Electromagnetic compatibility - Medical
electrical equipment. General requirements for basic safety and
essential performance - Collateral standard