Safety Precautions - EDAN F9 User Manual

F9, F9 Express Fetal & Maternal Monitor User Manual

1.5 Safety Precautions

WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the operation of the instrument.
For using safety:
1 The monitor or FTS-3 telemetry system (hereinafter called FTS-3) is provided for the
use of qualified physicians or personnel professionally trained.
2 The monitor is not intended for use in intensive care units (ICU), operating rooms or
for home use.
3 Do not switch on the monitor until all cables have been properly connected and
verified.
4 EXPLOSION HAZARD - Do not use the monitor or FTS-3 system in the presence of
flammable anesthetics or other materials.
5 SHOCK HAZARD - The power receptacle must be a three-wire grounded outlet.
Never try to adapt the three-prong plug to fit a two-slot outlet. A hospital grade outlet
is required. If the outlet has only two slots, make sure that it is replaced with a
three-slot grounded outlet before attempting to operate the monitor.
6 Multiple portable socket-outlets shall not be placed on the floor.
Additional multiple socket-outlet or extension cord can't be connected to the system.
7
8 The multiple portable socket-outlet provided with the system shall be only used for
supplying power to equipment which is intended to form part of the system. If the
electrical device that does not belong to the system plug in the socket, the total
power may exceed the maximum load of the separating transformer and cause high
temperature and fire. Enclosure leakage current within the system exceeds the
standard limit, which may lead an electric risk.
9 SHOCK HAZARD - Do not attempt to connect or disconnect a power cord with wet
hands. Make certain that your hands are clean and dry before touching a power
cord.
10 Do not touch accessible parts of non-medical electrical equipment and the patient
simultaneously. Do not touch the signal input or output connector and the patient
simultaneously.
11 Accessory equipment connected to the analog and digital interfaces must be
certified according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data
processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all
configurations shall comply with the valid version of the system standard IEC/EN
60601-1. Anybody who connects additional equipment to the signal input connector
or signal output connector to configure a medical system must ensure that the
system complies with the requirements of the valid version of the system standard
IEC/EN 60601-1. If in doubt, consult our technical service department or your local
distributor.
WARNING
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Safety Guidance