M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance
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WARNING
36 The medical electrical equipment needs to be installed and put into service according
to the EMC Information provided in this user manual.
37 If device conflict occurs when monitor is connected to gateway, please modify the IP
address of the conflicted monitor.
38 Do not touch accessible parts of medical or non-medical electrical equipment in the
patient environment and the patient simultaneously, such as USB connector, VGA
connector or other signal input/output connectors.
39 Please disinfect timely to prevent cross infection between patients.
40 Connecting any accessory (such as external printer) or other device (such as the
computer) to this monitor makes a medical system. In that case, additional safety
measures should be taken during installation of the system, and the system shall provide:
a) Within the patient environment, a level of safety comparable to that provided by
medical electrical equipment complying with IEC/EN 60601-1, and
b) Outside the patient environment, the level of safety appropriate for non-medical
electrical equipment complying with other IEC or ISO safety standards.
41 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.
42 Portable and mobile radio frequency (RF) communications equipment can affect
medical electrical equipment, please refer to the recommended separation distances
provided in Appendix A2 EMC Information.
43 Setting alarm limits to extreme values may cause the alarm system to become
ineffective. It is recommended to use the default settings.
44 The monitors are intended for use by trained healthcare professionals in hospital
environments.
45 Operation of the equipment exceeding specified physiological signal or the
operational specification may cause inaccurate results.
46 SHOCK HAZARD-To avoid the RISK of electric shock, this equipment must only be
connected to a SUPPLY MAINS with protective earth.
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.
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