Reocor S - BIOTRONIK USA - News

83 Technical Safety
Technical Safety
WARNING!
The external pacemaker Reocor S 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 international 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 requirements for defibrillation protection
stipulated in the international standards.
• The closed protective cover protects the pacemaker
against dripping water.
The temporary leads that are connected to Reocor S
represent 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 accordance with established guidelines.
The pacemaker must not be used in areas at risk for
explosion.
All additional maintenance work and repairs should
only be performed by BIOTRONIK.
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