EDAN F15 Series User Manual page 14

Traditional 510(k) of Fetal & Maternal Monitor
F15 Series Fetal & Maternal Monitor User Manual
32 Do not apply the monitor during electro-surgery or MRI; otherwise it might result in
harming the patient or the operator.
33 ECG cables may be damaged when connected to a patient during defibrillation. Check
cables for functionality before using them again.
34 Only 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.
35 After defibrillation, the screen display recovers within 10 seconds if the correct electrodes
are used and applied based on the manufacturers' instructions.
36 Any non-medical equipment (such as the external printer) is not allowed to be used within
the patient vicinity (1.5m/6ft.).
37 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.
38 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.
39 Never reuse disposable transducers, sensors, accessories, and so forth that are intended
for single use, or single patient use only. Reuse may compromise device functionality and
system performance, and cause a potential hazard.
40 Do not use a damaged transducer or one with exposed electrical contacts.
41 When connecting devices for acquiring measurements, always position cables and NIBP
tubing carefully to avoid entanglement or potential strangulation.
42 Do not service or maintain the monitor or any accessory which is in use with the patient.
43 Assembly of the monitor and modifications during actual service life shall be evaluated
based on the requirements of IEC60601-1.
44 The disposable ECG electrode cannot be reused and cannot be used in case of package
damage.
45 The instrument is precise; especially the touch screen is fragile. Therefore, for fear of
instrument damage, do not operate the instrument violently, and avoid falling and
impacting during usage.
For proper monitoring:
46 Alarms must be set up according to different situations of patients. Make sure that audio
sounds can be activated when an alarm occurs.
47 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.
48 Clinical decision making based on the output of the device is left to the discretion of the
provider.
49 Do not put the sensor on extremities with arterial catheter or venous syringe.
50 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.
51 The disposable accessories are intended to be used only once. Dispose of them properly
after use and do not reuse them.
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Safety Guidance
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