EDAN F9 User Manual page 20

F9, F9 Express Fetal & Maternal Monitor User Manual
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 Electromagnetic Interference - Ensure that the environment in which the monitor
or FTS-3 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 or FTS-3 may be interfered.
11 Electromagnetic Interference - Do not use mobile phones nearby in the process of
monitoring
12 Operation of the equipment below the minimum amplitude may cause inaccurate
results.
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 or FTS-3 system 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.
CAUTION
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Safety Guidance