natus UltraPro S100, User Manual, Page: 11 / 88

13 September, 2018
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Preface
Safety
Any interruption of the protective earth conductor inside or out-
side of the device or disconnection of the protective/functional earth connector is
likely to make the device dangerous. Intentional interruption is prohibited. The
protective earth / ground conductor should be checked regularly.
Adhere to the following recommendations for safe operation of the device:
•
When connecting medical equipment being supplied from an outlet located in
a non-medically used room, or when connecting non-medical electrical
equipment to this device, pay attention to the requirements of IEC 60601-1
(IEC 60601-1-1), Safety Requirements for medical electrical systems, cf. the
text on IEC 60601-1 (IEC 60601-1-1), further below in this section.
• When the device is connected to its mains supply, connectors may be live, and
any opening of covers or removal of parts possible only with the aid of a tool
is likely to expose live parts.
•
The device must be disconnected from all voltage sources before being opened
for any adjustment, replacement, maintenance or repair.
• Service must be referred to Natus Neurology Incorporated authorized service
personnel, except for such works described in this manual as being performed
by the operator.
•
Make sure that only fuses with the required rated current and of the specified
type are used for replacement. The use of makeshift fuses and the short-
circuiting of fuse holders are prohibited.
• Where more than one piece of equipment is connected to the patient, attention
must be paid to the summation of patient leakage currents.
•
Whenever it is likely that the protection has been impaired, the device shall be
made inoperative and be secured against any unintended operation.
Call qualified service personnel to conduct at least a functional test and a safety
check that should include the following:
• Insulation test.
•
Ground continuity test.
• Leakage current test, according to IEC 60601-1.
The protection is likely to be impaired if, for example, the device:
•
Shows visible damage.
• Fails to perform the intended function(s).
•
Has been subject to severe transport stresses.