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AAMI MP80601-2-49 pdf free download

AAMI MP80601-2-49 pdf free download.Medical electrical equipment—Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors.
201.7 M E EQUIPMENT identification, marking and documents Clause 7 of the general standard applies, except as follows: 201 .7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts Additional subclause: 201 .7.2.1 01 Connectors for APPLIED PARTS Connectors on a MULTIFUNCTION PATIENT MONITOR intended to connect APPLIED PARTS shall be marked to identify the APPLIED PARTS that can be connected. NOTE Examples of markings are MODEL OR TYPE REFERENCE of the APPLI ED PART , function of the APPLIED PART (e.g. ECG, ECG/respiration, SpO 2 , temperature, etc.) or color coding. 201 .7.9.2.2 Warning and safety notices Addition: The instructions for use shall include a warning that defibrillator protection requires use of MANUFACTURER specified APPLIED PARTS , PATIENT CABLES , LEAD WIRES , TRANSDU CERS and ACCESSORIES . 201 .7.9.2.9 Operating instructions Additional subclause: 201 .7.9.2.9.1 01 Additional instructions for use The instructions for use shall include the following: a) that the use of the MULTIFUN CTION PATIENT MON ITOR is restricted to one PATIENT at a time; b) precautions to take when using a defibrillator on a PATIENT , if APPLIED PARTS not being protected against the effects of defibrillation are being used; a description of how the discharge of a defibrillator affects the MULTIFUNCTION PATIENT MON ITOR ; c) information indicating whether the MULTIFUNCTION PATIENT MONITOR incorporates means to protect the PATIENT against burns when used with H IGH – FREQUEN CY ( HF ) SURGICAL EQUIPMENT and advice regarding the location of ELECTRODES , TRAN SDUCERS , etc. to reduce the HAZARDS of burns in the event of a defect in the NEUTRAL ELECTRODE connection of the HF SURGICAL EQUIPMENT .201.1 0 Protection against unwanted and excessive radiation HAZARDS Clause 1 0 of the general standard applies. 201.1 1 Protection against excessive temperatures and other HAZARDS Clause 1 1 of the general standard applies, except as follows: 201 .1 1 .6.5 * Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS Addition: T RANSPORTABLE MULTIFUNCTION PATIENT MON ITORS or TRANSPORTABLE parts of the MULTIFUNCTION PATIENT MONITORS separable while remaining functioning shall have an ingress protection of at least IPX1 so that, in the event of accidental wetting, no loss of BASIC SAFETY or ESSENTIAL PERFORMAN CE results from the ingress of liquids Compliance is checked by the following test: Expose the TRANSPORTABLE MULTIFU NCTION PATIENT MON ITOR to wetting according of IEC 60529:1989, IEC 60529:1989/AMD1:1999 and IEC 60529:1989/AMD2:2013. Immediately after exposure, remove any visible moisture on the ENCLOSURE and confirm that BASIC SAFETY and ESSENTIAL PERFORMANCE of this document are maintained.202.7.1 .1 01 * E MISSIONS test setup MULTIFUNCTION PATIENT MONITORS shall be tested configured with the maximum number of PHYSIOLOGICAL MONITORIN G UN ITS . All specified PHYSIOLOGICAL MONITORIN G UNITS shall be tested. Representative samples from each family of PATIENT CABLES , LEAD WIRES , sensors, probes and/or TRANSDUCERS with similar construction listed in the ACCOMPANYING DOCUMENTS shall be tested with the corresponding PHYSIOLOGICAL MONITORIN G UNITS specified by the MANUFACTURER . MULTIFUNCTION PATIENT MONITORS shall be tested with all PATIENT CABLES , LEAD WIRES , sensors, probes and TRANSDUCERS and with all SIP / SOP cables connected to the MULTIFUN CTION PATIEN T MONITOR (see Figure 202.1 01 ). The distances of SIP / SOP cables between the open end and floor (ground plane) shall be ≥ 40 cm.AAMI MP80601-2-49 pdf download.

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