EDAN elite V5 User Manual page 19

Patient Monitor User Manual
29 Without use of data store function, all data measured (including trend data, review
data, alarm events and so on) are cleared either when the monitor is turned off or
when the monitor is powered down in the process of monitoring.
30 The appliance coupler or mains plug is used as isolation means from supply mains.
Position the monitor in a location where the operator can easily access the
disconnection device.
31 Assembly of the monitor and modifications during actual service life shall be
evaluated based on the requirements of IEC60601-1.
32 If leakage or foul odor is detected, ensure that there's no fire around.
33 Additional multiple socket-outlets or extension cords can't be connected to the
system.
34 Only items that have been specified as part of the system or specified as being
compatible with the system can be connected to the system.
35 Connecting any accessory (such as external printer) or other device (such as the
computer) to this monitor makes a medical system. In that case, additional safety
measures should be taken during installation of the system, and the system shall
provide:
a) Within the patient environment, a level of safety comparable to that provided by
medical electrical equipment complying with IEC/EN 60601-1, and
b) Outside the patient environment, the level of safety appropriate for non-medical
electrical equipment complying with other IEC or ISO safety standards.
36 All the accessories connected to system must be installed outside the patient vicinity,
if they do not meet the requirement of IEC/EN 60601-1.
37 The medical electrical equipment needs to be installed and put into service according
to the EMC Information provided in this user manual.
38 Portable and mobile RF communications equipment can affect medical electrical
equipment; refer to the recommended separation distances provided in this user
manual.
39 Using accessories other than those specified may result in increased electromagnetic
emission or decreased electromagnetic immunity of the monitoring equipment.
40 The monitor should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, you must check that normal operation is
possible in the necessary configuration before you start monitoring patients.
41 Do not touch accessible parts of medical or non-medical electrical equipment in the
patient environment and the patient simultaneously, such as USB connector, VGA
connector or other signal input/output connectors.
WARNING
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Intended Use and Safety Guidance