F15 Series Fetal & Maternal Monitor User Manual Safety Guidance
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CAUTION
11 Electromagnetic Interference - Ensure that the environment in which the monitor is
installed is not subject to any source of strong electromagnetic interference, such as CT,
radio transmitters, mobile phone base stations, etc. Even though other devices are in
accordance with national standard radiation requirements, the monitor may be interfered.
12 Electromagnetic Interference - Do not use mobile phones nearby in the process of
monitoring.
13 Electromagnetic Interference - Fetal parameters, especially ultrasound and ECG, are
sensitive measurements involving small signals, and the monitoring equipment contains
very sensitive high gain front-end amplifiers. Immunity levels for radiated RF
electromagnetic fields and conducted disturbances induced by RF fields are subject to
technological limitations. To ensure that external electromagnetic fields do not cause
erroneous measurements, it is recommended to avoid the use of electrically radiating
equipment in close proximity to these measurements.
14 Electromagnetic Interference - The monitor should not be used adjacent to or stacked with
other equipment, refer to section A7.4 Recommended Separation Distances.
15 Electromagnetic interference is not unique to this system but is characteristic of fetal
patient monitoring equipment in use today. This performance is due to very sensitive high
gain front-end amplifiers required to process the small physiological signals from the
patient. Among the various monitoring systems already in clinical use, interference from
electromagnetic sources is rarely a problem.
16 The medical electrical equipment needs to be installed and put into service according to
Appendix 7 EMC Information.
17 Portable and mobile RF communications equipment can affect medical electrical
equipment, refer to section A7.4 Recommended Separation Distances.
18 Sterility cannot be guaranteed if package of the fetal spiral electrode is broken or opened.
19 The fetal spiral electrode has been sterilized by gamma radiation. Do not re-sterilize.
20 The device and reusable accessories could be sent back to the manufacturer for recycling
or proper disposal after their useful lives.
21 The recommended battery charging temperature ranges from 0°C (32 ºF ) to 35°C (95 ºF ).
22 If the terminals of the battery become dirty, wipe with a dry cloth before using the battery.
23 The device and accessories are to be disposed of according to local regulations after their
useful lives. Alternatively, they can be returned to the dealer or the manufacturer for
recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose them
together with house-hold garbage. At the end of their life hand the batteries over to the
applicable collection points for the recycling of waste batteries. For more detailed
information about recycling of this product or battery, please contact your local Civic
Office, or the shop where you purchased the product.
Traditional 510(k) of Fetal & Maternal Monitor
014_14.1_F15_Series_User_Manual
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