EDAN F15 Series User Manual page 13

Traditional 510(k) of Fetal & Maternal Monitor
F15 Series Fetal & Maternal Monitor User Manual
16 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.
17 Using accessories other than those specified by the manufacturer may result in increased
electromagnetic emissions or decreased electromagnetic immunity of the device.
18 The device should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, the device should be observed to verify normal
operation in the configuration in which it will be used.
19 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.
20 Do not exceed the maximum permitted load when using multiple portable socket-outlets to
supply the system.
21 SHOCK HAZARD – Do not connect non-medical electrical equipment, which has been
supplied as a part of the system, directly to the wall outlet when the non-medical equipment
is intended to be supplied by a multiple portable socket-outlet with an isolation transformer.
If multiple instruments are connected to a patient, the sum of the leakage currents may
exceed the limits given in the IEC/EN 60601-1 and may pose a safety hazard. Consult your
service personnel.
22 SHOCK HAZARD - Don't connect electrical equipment, which has not been supplied as a
part of the system, to the multiple portable socket-outlet supplying the system.
23 Do not connect any equipment or accessories that are not approved by the manufacturer
or that are not IEC 60601-1 approved to the monitor. The operation or use of non-approved
equipment or accessories with the monitor is not tested or supported, and monitor
operation and safety are not guaranteed.
24 Do not apply this monitor and other ultrasonic equipment simultaneously on a same
patient, in case of possible hazard caused by leakage current superposition. Do not apply
this monitor simultaneously with other PATIENT-connected equipment, such as, a cardiac
pacemaker or other electrical stimulators, on the same patient.
25 Do not place the TOCO transducer on the oedematous or fragile tissue; change the
measuring sites after half an hour.
26 The monitor can only be used on one patient at a time.
27 SHOCK HAZARD - Do not remove the top panel cover during operation or while power is
connected.
28 Equipment and devices that connect to the monitor should form an equipotential body to
ensure effective grounding.
29 No modification of this equipment is allowed without authorization of the manufacturer. If
this equipment is modified, appropriate inspection and testing must be conducted to
ensure continued safe operation.
30 Only connect accessories supplied or recommended by the manufacturer to the device.
31 The system should be operated by the doctor or under the doctor's instructions.
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Safety Guidance
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