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Reocor S - BIOTRONIK USA - News

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88 Conformity According to IEC 60601-1-2<br />

Manufacturer guidelines and declaration –<br />

resistance to electromagnetic interference <br />

(IEC 60601-1-2: Table 2)<br />

English<br />

Test of<br />

resistance to<br />

interference<br />

Electrostatic<br />

discharge (ESD)<br />

according to<br />

IEC 61000-4-2<br />

The device is intended for use in an electromagnetic<br />

environment as described below. The user of the<br />

device should make sure that it is used in such an<br />

environment.<br />

Test level<br />

according to<br />

IEC 60601<br />

±6 kV contact discharge<br />

±8 kV air discharge<br />

Fast transient Not applicable<br />

electric interference/bursts<br />

according to<br />

IEC 61000-4-4<br />

Surges voltages Not applicable<br />

(surges)<br />

according to<br />

IEC 61000-4-5<br />

Voltage drops, Not applicable<br />

brief interruptions<br />

and fluctuations<br />

in the<br />

supply voltage<br />

according to<br />

IEC 61000-4-11<br />

Magnetic field<br />

at the supply<br />

frequencies<br />

(50/60 Hz)<br />

according to<br />

IEC 61000-4-8<br />

Compliance<br />

level<br />

±6 kV contact<br />

discharge<br />

±15 kV air<br />

discharge<br />

Guidelines for the electro-<br />

magnetic environment<br />

Floors should be made of<br />

wood, cement or ceramic tiles.<br />

When the floor consists of a<br />

synthetic material, the relative<br />

humidity must be at least 30%.<br />

3 A/m 30 A/m The magnetic field strength<br />

should correspond to the<br />

typical value in business and<br />

hospital environments.

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