Idiomas disponibles
Idiomas disponibles
29
Technical Safety
The external pacemaker Reocor D meets the international
standards for the safety of electro-medical devices according
to IEC 60601-1 and IEC 60601-1-2, as well as the interna-
tional standard IEC 60601-2-31 for temporary, external
pacemakers.
The following special features offer safety for the patient:
•
No metal parts that can be touched, according to the
definition of the IEC.
•
The design meets the standard for the device class CF
(cardiac floating) and is approved for direct treatment of
the heart. The pacemaker complies with the require-
ments for defibrillation protection stipulated in the inter-
national standards.
•
The closed protective cover protects the pacemaker
against dripping water.
WARNING!
The temporary leads that are connected to Reocor D repre-
sent a low-impedance conductor to the myocardium for
electric current. Therefore line-powered devices that are
operated in the patient's vicinity must be grounded in accor-
dance with established guidelines.
The pacemaker must not be used in areas at risk for explo-
sion.
All additional maintenance work and repairs should only be
performed by BIOTRONIK.
