Operator's Manual

Operator Manual – Prodigy Sleep System
Revision: 04; CCRF-625
Effective Date: 30-Jan-19
Document Number: YST-UDoc-PR2-001-04
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make it suitable for use in all
establishments, including
domestic establishments and
those directly connected to the
public low-voltage power supply
network that supplies buildings
used for domestic purposes,
provided the EEG and ORP
outputs on the Prodigy Sleep
System are not used. RF
Emmissions CISPR 11
compliance class A, Harmonic
emissions and Voltage
Fluctuations/Flickers emissions
are not applicable for the
device.
Voltage Fluctuations/ Flicker
Emissions IEC 61000-3-3
N/A
Table 5 - Guidance and manufacturer's declaration - Electromagnetic immunity
The Prodigy Sleep System is intended for use in the electromagnetic environment specified below.
The customer or the user of the Prodigy Sleep System should assure that it is used in such an
environment.
When the Prodigy Sleep System is exposed to electromagnetic (EM) disturbances, the system may
show abnormal behaviour. For instance, the measured traces may become obscured, the software
may crash, or, in case of very high level transient voltage events (e.g. ESD), parts of the system may
even become defective.
Due to the device’s intended use of data collection, a deviation in testing was made to test to lower
compliance levels. It should be noted that in the event of higher ESD levels, there is no risk of harm to
patient or environment, and this does not present a chance of misdiagnosis.
Immunity Test
IEC 60601 Test Level
Compliance Level
Guidance
Electrostatic Discharge
(ESD)IEC 61000-4-2
±8 kV (contact)
±15 kV (air)
±4 kV (contact)
±8 kV (air)
Floors should be wood,
concrete or ceramic
tile. If floors are
covered with synthetic
material, the relative
humidity should be at
least 30%.
Electrical fast
transient/burst IEC
61000-4-4
±1 kV for input/output
lines
±2 kV for AC and DC
powerlines
N/A
Mains power quality
should be that of a
typical commercial or
hospital equipment.
Surge IEC 61000-4-5
±1 kV diferential mode
±2 kV common mode
N/A
Mains power quality
should be that of a
UNCONTROLLED COPY - SGS - 30-JAN-19