EDAN F9 User Manual page 17

F9, F9 Express Fetal & Maternal Monitor User Manual
24 Only connect accessories supplied or recommended by the manufacturer to the
device.
25 The system should be operated by the doctor or under the doctor's instructions.
26 Do not apply the monitor during electro-surgery or MRI; otherwise it might result in
harming the patient or the operator.
27 ECG cables may be damaged when connected to a patient during defibrillation.
Check cables for functionality before using them again.
28 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.
29 After defibrillation, the screen display recovers within 10 seconds if the correct
electrodes are used and applied based on the manufacturers' instructions.
30 Any non-medical equipment (such as the external printer) is not allowed to be used
within the patient vicinity (1.5m/6ft.).
31 Make sure that the power is turned off and the power cord is disconnected from the
AC socket before connecting or disconnecting equipment. Otherwise, the patient or
operator may receive electrical shock or other injury.
32 Parts and accessories used must meet the requirements of the applicable IEC 601
series safety standards, and/or the system configuration must meet the
requirements of the IEC 60601-1 medical electrical systems standard.
33 Do not service or maintain the monitor or any accessory which is in use with the
patient.
34 Assembly of the monitor and modifications during actual service life shall be
evaluated based on the requirements of IEC60601-1.
For proper monitoring:
35 Alarms must be set up according to different situations of patients. Make sure that
audio sounds can be activated when an alarm occurs.
36 Do not perform NIBP measurements on patients with sickle-cell disease or under
any condition where the skin is damaged or expected to be damaged.
37 Clinical decision making based on the output of the device is left to the discretion of
the provider.
38 Do not put the sensor on extremities with arterial catheter or venous syringe.
39 Do not apply the cuff to a limb that has an intravenous infusion or catheter in place.
This could cause tissue damage around the catheter when infusion is slowed or
blocked during cuff inflation.
40 The disposable accessories are intended to be used only once. Dispose of them
properly after use and do not reuse them.
41 The spiral electrode and IUP catheter are disposable and should not be reused.
WARNING
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Safety Guidance