F15 Series Fetal & Maternal Monitor User Manual Safety Guidance
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WARNING
72 When the device is running on lithium battery power, do not replace the lithium battery
during operation of the device.
73 High internal temperature may also cause the lithium battery unable to be charged. Keep
the device at room temperature and move it away from heat sources or out of direct
sunlight. The lithium battery will resume charging when the temperature is within range
again.
74 Lithium batteries should be charged, used and stored in places far away from static
electricity.
75 Only rechargeable button cell supplied or recommended by EDAN can be used. The
rechargeable button should be replaced by serviceman authorized by EDAN if needed.
76 Do not replace the lithium battery in the transducer by yourself. If you need to replace the
lithium battery, please contact EDAN or qualified service professionals authorized by EDAN
for replacement.
77 If any serious incident that has occurred in relation to the device, user and/or patient
should report to the manufacturer and the competent authority of the Member State in
which the user and/or patient is established.
CAUTION
1 The device is designed for continuous operation. Avoid liquid splashing on the device.
2 Refer servicing to qualified personnel.
3 Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine, dust
area, high-temperature and humid environment.
4 When installing the unit into a cabinet, allow for adequate ventilation, accessibility for
servicing, and room for adequate visualization and operation.
5 Do not operate the unit if it is damp or wet because of condensation or spills. Avoid using
the equipment immediately after moving it from a cold environment to a warm, humid
location.
6 The appliance coupler or mains plug is used as isolation means from supply mains.
Position the monitor in a location where the operator can easily access the disconnection
device.
7 Do not sterilize the monitor or any accessory with autoclave or gas.
8 Switch off the system power before cleaning. Cleaning consists of removing all dust from
the exterior surface of the equipment with a soft brush or cloth.
9 Only the sensor and cable of US/TOCO transducers are watertight. Pay attention not let
any liquid enter the transducer plug.
10 The materials with which the patient or any other person can come into contact conform to
the standard of EN ISO 10993-1.
Traditional 510(k) of Fetal & Maternal Monitor
014_14.1_F15_Series_User_Manual
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