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For safety reasons, the following precautions must be observed:
DANGER
Please observe all warning information present on the device and in the Instruction Manual.
There is a danger to life if warnings are not obeyed. Severe personal injury or damage to property
may occur.
Observe the safety requirements of EN 60601-1 (IEC 60601-1)
To prevent injury to patients and users, connect the electrical system in accordance with the safety
requirements of EN 60601-1 (IEC 60601-1) for "Safety requirements for medical electrical systems".
Connecting the protective earth conductor
If the device is connected to line power, the device must be connected to a protective conductor.
This is the only way to ensure that the touch leakage current in a first fault event does not exceed
500 µA.
The interruption of the device's protective conductor is considered a first fault event in accordance
with EN 60601-1.
Use the following measures to ensure that the leakage currents remain below the specified limits:
•
Separators for signal input or signal output unit
•
Use of a safety isolating transformer
•
Use of the additional protective conductor terminal
Mounting of the monitor: The monitor's suspension arm must have its own protective conductor. This
protective conductor, together with the protective conductor of the monitor, ensures that the housing
leakage current always remains less than 500 µA, even in the event of a first fault event.
No unauthorized opening of the device / no unauthorized service or maintenance work
The device may only be opened by qualified personnel. Likewise, service or maintenance work may
only be carried out by qualified personnel. There is a risk of electric shock.
No liability is accepted for death and injury to persons or damage to property resulting from work car-
ried out by non-qualified personnel.
Do not touch components in the device
If the device is connected to line power, components in the device are subject to high voltages.
Touching the components may be fatal.
No contact between device and patients
The device is not suitable for direct contact with patients. Device and patient must never be touched
simultaneously. Otherwise there is a danger to life and limb.
RadiForce LS580W
Instruction for Use, 02/2014
Safety instructions
2.1 General safety notes
7
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