M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance
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WARNING
42 The medical electrical equipment needs to be installed and put into service according
to the EMC Information provided in this user manual.
43 Portable and mobile RF communications equipment can affect medical electrical
equipment; refer to the recommended separation distances provided in Appendix A2
EMC Information.
44 Operation of the equipment exceeding specified physiological signal or the
operational specification may cause inaccurate results.
45 The use of patient cable and other accessories not supplied by the manufacturer may
result in increased emissions or decreased immunity of the equipment.
46 The monitor should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, you must check that normal operation is
possible in the necessary configuration before you start monitoring patients.
47 When the monitor is used with HF surgical equipment, the transducer and the cables
must be avoided from conductive connection to the HF equipment. This is to protect
against burns to the patient.
48 To protect the monitor from damage during defibrillation, for accurate measurement
information and to protect against noise and other interference, use only accessories
specified by EDAN.
49 No modification of this equipment is allowed without authorization of the
manufacturer. If this equipment is modified, appropriate inspection and testing must
be conducted to ensure continued safe operation.
50 Only recommended batteries can be used for the monitor.
51 If several items of medical equipment are interconnected, pay attention to the sum of
the leakage currents, otherwise it may cause shock hazard. Consult your service
personnel.
52 The device must be connected to the ground to avoid signal interference.
53 Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the monitor, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
54 Route all cables carefully to avoid possible entanglement, apnea, or electrical
interference. For the device mounted over the patient, sufficient precautionary
measures should be taken to prevent it from falling on the patient.
55 Make sure networking function is used in a secure network environment.
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