M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance
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CAUTION
1 Federal law (U.S.) restricts this device to sale by or on the order of a physician.
2 Electromagnetic Interference – Ensure the environment in which the monitor is
installed is not subject to any sources of strong electromagnetic interference, such as
radio transmitters, mobile telephones, microwaves, etc.
3 The monitor is designed for continuous operation and is “ordinary” (i.e. not drip or
splash-proof).
4 Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine,
dust area, high-temperature and humid environment.
5 The monitor is suitable for use in the presence of electrosurgery. When the monitor is
used with HF surgical equipment, user (doctor or nurse) should be cautious about
patient safety.
6 Do not immerse transducers in liquid. When using solutions, use sterile wipes to
avoid pouring fluids directly on the transducer.
7 The device and reusable accessories may be sent back to the manufacturer for
recycling or proper disposal after their useful lives. Alternatively, they can be returned
to the dealer or the manufacturer for recycling or proper disposal.
8 Avoid liquid splash and excessive temperature. The working temperature must be
kept between 0 C and +40 C, and it is recommended to be kept between +10 C
and +40 C when the monitor is equipped with TEMP module. The temperature
should be kept between -20 C and +55 C during transportation and storage, and it
is recommended to be kept between -20 C and +50 C when the monitor is
equipped with TH module.
9 If the monitor gets damp, put it in dry circumstance to dry it until it can work normally. If
liquid pours on the monitor, please contact the service personnel authorized by EDAN.
10 Remove a battery whose life cycle has expired from the monitor immediately.
11 Before using the device, the equipment, patient cable and electrodes etc. should be
checked. Replacement shall be taken if there is any evident defect or signs of aging
which may impair the safety or performance.
12 A potential hazard can exist if different alarm presets are used for the same or similar
equipment in any single area.
13 Assembly of the monitor and modifications during actual service life shall be evaluated
based on the requirements of IEC60601-1.
14 Disposable devices are intended for single use only. They should not be reused as
performance could degrade or contamination could occur.
15 A ventilated environment is required for monitor installation. Do not block up the
ventilation grille at the back of the device.
16 Poor connection might be caused by frequently plugging and unplugging the power
cord. Check the power cord regularly and replace it in time.
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