Compliance To En/Iec 60601-1-2: 2007 - Bayer HealthCare Medrad MRXperion Operating Manual

Operation Manual
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Compliance to EN/IEC 60601-1-2: 2007

Special precautions regarding Electromagnetic Compatibility (EMC), are required for installation and use of this system.
The system complies with the requirements of:
EN 60601-1-2:2007 Medical Electrical Equipment-Part 1: General Requirements for Safety, Amendment No. 2.
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Collateral Standard: Electromagnetic Compatibility Requirements and Tests.
EN 55011:2009/A1:2010 Limits and methods of measurement of radio disturbance, characteristics of industrial,
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scientific and medical radio frequency equipment.
EN 61000-3-2:2006/A2:2009 edition - Electromagnetic Compatibility - Part 3: Testing and measurement
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techniques - Section 2: Harmonic current emissions test.
EN 61000-3-3:2008 edition - Electromagnetic Compatibility - Part 3: Testing and measurement techniques- Section
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3: Voltage fluctuation and flickers test.
EN 61000-4-2:2009 edition - Electromagnetic Compatibility - Part 4: Testing and measurement techniques- Section
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2: Electrostatic discharge immunity test.
EN 61000-4-3 /A2:2010 edition - Electromagnetic Compatibility - Part 4: Testing and measurement techniques-
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Section 3: Radiated, radio-frequency, electromagnetic field immunity test.
EN 61000-4-4:2004/A1:2010 edition - Electromagnetic Compatibility - Part 4: Testing and measurement
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techniques- Section 4: Electrical fast transient / Burst immunity test.
EN 61000-4-5:2006 edition - Electromagnetic Compatibility - Part 4: Testing and measurement techniques- Section
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5: Surge immunity test.
EN 61000-4-6:2009 edition - Electromagnetic Compatibility - Part 4: Testing and measurement techniques- Section
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6: Conducted immunity test.
EN 61000-4-8:2010 edition - Electromagnetic Compatibility - Part 4: Testing and measurement techniques- Section
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8: Power frequency magnetic field immunity test.
EN 61000-4-11:2004 edition - Electromagnetic Compatibility - Part 4: Testing and measurement techniques-
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Section 11: Voltage dips and interruptions immunity test.
NOTICE
Electro-Mechanical Hazard - Equipment Damage may result or system may fail to operate.
Do not expose to high magnetic fields. Portable and mobile RF communications equipment can affect the system.
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Use only accessories and options from Bayer that are designed specifically for the system. Other non-Bayer accessories or options
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may cause equipment damage or may result in increased emissions or decreased immunity of the system. System accessories
listed in this manual comply with the requirements of electromagnetic emissions and immunity standards EN/IEC 60601-1-
2:2007 (Edition 3).
If adjacent or stacked use is necessary, the system should be observed to verify normal operation in the configuration in which it
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will be used.
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