F15 Series Fetal & Maternal Monitor User Manual Safety Guidance
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52 The spiral electrode and IUP catheter are disposable and should not be reused.
53 The IUPC is neither intended nor approved for measuring intrauterine pressure
extraovularly; attempting to do so may lead to maternal discomfort or injury.
54 FTS-3 transducers have priority over F15 series US Transducers, DECG Fetal & Maternal
Module, TOCO transducer and FECG Fetal&Maternal Module. When FTS-3 transducers get
on line, F15 series US Transducers, DECG Fetal & Maternal Module, TOCO transducer and
FECG Fetal&Maternal Module will be disabled.
For using the Battery:
55 Before using the rechargeable lithium-ion battery (hereinafter called lithium battery), be
sure to read the user manual and safety precautions thoroughly.
56 The lithium battery can only be used for this device.
57 The lithium battery can only be charged in this device.
58 Do not reverse the lithium battery polarity.
59 Do not connect the positive (+) and negative (-) terminals with metal objects such as lead
wire, which can result in short circuits.
60 The cycle life of the lithium battery is 300 times. The service life of the lithium battery may
shorten if it is used inappropriately. It is recommended to replace the lithium battery after
300 charge-discharge cycles, or it may cause safety risks such as heat and liquid leakage,
and risks such as failure or decline of performance.
61 Do not heat or throw the lithium battery into a fire.
62 Do not immerse, throw or wet the lithium battery in water, beverages or other liquids.
63 Do not use or leave lithium battery at high temperature (charging>35℃, discharging>60℃,
such as in direct sunlight or in a very hot car), otherwise it may cause overheat, fire,
malfunction to the lithium battery, shorten the service life of the lithium battery, or damage
the lithium battery.
64 Do not place the lithium battery near microwave equipment or other cooking devices. If the
lithium battery is heated or subjected to strong electromagnetic radiation, liquid leakage,
heat, smoke, fire, etc. may occur.
65 Do not hit with a hammer, step on or throw or drop to cause strong shock.
66 Do not weld the lithium battery directly.
67 Do not use a lithium battery of other specifications.
68 Do not use a lithium battery with serious scratch or deformation.
69 Keep lithium batteries out of the reach of children.
70 Power off the device, remove and stop using the lithium battery if abnormal heat, odor,
discoloration, deformation or abnormal condition is detected during use, charge, or
storage, or it may cause safety accidents such as heat, smoke, and fire.
71 Do not touch a leaking lithium battery. If the liquid leaked from the lithium battery gets into
eyes, do not rub the eyes. Wash them well with clean water and see a doctor immediately.
Traditional 510(k) of Fetal & Maternal Monitor
014_14.1_F15_Series_User_Manual
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