NURSAL PL-029U Operating Manual
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Contents
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6 IEC 60601-1-11/ EN 60601-1-11 Medical electrical equipment – Part 1-11: General requirementsfor basic safety and essential performance – Collateral standard: Requirements for medicalelectrical equipment and medical electrical systems used in home healthcare environment IEC 62304/ EN 62304 Medical device software - Software life-cycle processes IEC 62366/ EN 62366 Medical devices – Application of usability engineering to medical devices ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a riskmanagement processElectromagnetic Compatibility and FCC Compliance Statement1) This product needs special precautions regarding electromagnetic compatibility (EMC) and needs tobe installed and put into service according to the EMC information provided, and this unit can beaffected by portable and mobile radio frequency (RF) communications equipment.2) Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This mayresult in incorrect operation of the unit.3) Caution: This unit has been thoroughly tested and inspected to assure proper performance andoperation!4) Caution: This machine should not be used adjacent to or stacked with other equipment and that ifadjacent or stacked use is necessary, this machine should be observed to verify normal operation in theconfiguration in which it will be usedGuidance and manufacture’s declaration – electromagnetic emissionThe device is intended for use in the electromagnetic environment specified below. The customer of the user of the device shouldassure that it is used in such an environment.Emission test Compliance Electromagnetic environment – guidanceRF emissionsCISPR 11Group 1The device use RF energy only for its internal function.Therefore, its RF emissions are very low and are not likely tocause any interference in nearby electronic equipment.RF emissionCISPR 11Class BThe device is suitable for use in all establishments, includingdomestic establishments and those directly connected to thepublic low-voltage power supply network that suppliesbuildings used for domestic purposes.Harmonic emissionsIEC 61000-3-2Not applicable(internal battery powered) |
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