User's Manual

F Series Fetal & Maternal Monitor User Manual Safety Guide
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WARNING
11 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.
12 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.
13 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.
14 The monitor can only be used on one patient at a time.
15 SHOCK HAZARD - Do not remove the top panel cover during operation or while
power is connected. Only authorized service personnel could remove the unit cover.
16 Equipment and devices that connect to the monitor should form an equipotential
body to ensure effective grounding.
17 Only connect accessories supplied or recommended by the manufacturer to the
device.
18 The system should be operated by the doctor or under the doctors instructions.
19 Do not apply the monitor during electro-surgery or MRI; otherwise it might result in
harming the patient or the operator.
20 Only MECG, SpO2, NIBP and TEMP applied parts of the monitor are
defibrillation-proof. When a defibrillator is applied, keep other accessories away from
the patient. Otherwise it may result in damaging the monitor or harming the patient.
21 ECG cables may be damaged when connected to a patient during defibrillation.
Check cables for functionality before using them again.
22 After defibrillation, the screen display recovers within 10 seconds if the correct
electrodes are used and applied based on the manufacturers’ instructions.
23 Any non-medical equipment (such as the external printer) is not allowed to be used
within the patient vicinity (1.5m/6ft.).