EDAN F9 User Manual page 16

F9, F9 Express Fetal & Maternal Monitor User Manual
12 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.
13 Using accessories other than those specified by the manufacturer may result in
increased electromagnetic emissions or decreased electromagnetic immunity of the
device.
14 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.
15 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.
16 Do not exceed the maximum permitted load when using multiple portable
socket-outlets to supply the system.
17 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.
18 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.
19 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.
20 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.
21 The monitor can only be used on one patient at a time.
22 SHOCK HAZARD - Do not remove the top panel cover during operation or while
power is connected.
23 Equipment and devices that connect to the monitor should form an equipotential
body to ensure effective grounding.
WARNING
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Safety Guidance