F15 Series Fetal & Maternal Monitor User Manual Safety Guidance
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For using safety:
1 The monitor 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 No modification of this monitor is allowed.
4 Do not switch on the monitor until all cables have been properly connected and verified.
5 EXPLOSION HAZARD - Do not use the monitor in the presence of flammable anesthetics
or other materials.
6 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.
7 The protective earth conductor is required for EMC purposes. It has no protective function
against electric shock. Double and/or reinforced insulation protects this device against
electric shock.
8 Multiple portable socket-outlets shall not be placed on the floor.
9 Additional multiple socket-outlet or extension cord can’t be connected to the system.
10 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.
11 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.
12 SHOCK HAZARD-To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
13 Do not touch accessible parts of non-medical electrical equipment and the patient
simultaneously.
14 Do not touch the signal input or output connector and the patient simultaneously.
15 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.
Traditional 510(k) of Fetal & Maternal Monitor
014_14.1_F15_Series_User_Manual
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