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AS IEC 60601.1.8:2017 pdf free

AS IEC 60601.1.8:2017 pdf free.Medical electrical equipment
If an INTELLIGENT ALARM SYSTEM is provided, the instructions for use shall include, as applicable, an overview of how the ALARM SYSTEM:
a) determines an ALARM CONDITION on the basis of time, weightings, multiple variables, or other advanced processing (including, but not limited to,algorithms, neural networks,fuzzy logic, etc.);
b) generates ALARM SIGNALS for two or more ALARM CONDITIONS of equal priority (including, but not limited to, internal ranking, effect on generation of ALARM SIGNALS);
c) changes the previously-assigned priority or relative prioritization of a particular ALARM CONDITION (e.g., ESCALATION or DE-ESCALATION);
d) changes the ALARM SIGNAL GENERATION DELAY or ALARM CONDITION DELAY; and
e) changes the characteristics of the generated ALARM SIGNALS (for example, volume, pitch,tempo, urgency).
At least one visual ALARM SIGNAL that identifies the specific ALARM CONDITION and its priority shall be provided. This signal shall be perceived correctly (be legible) at a distance of 1 m from the equipment or part of the equipment or from the OPERATOR’S POSITION. This visual indication may be text placed beside an indicator light or text on a display. The presence of an ALARM CONDITION may be visually indicated (marked) with symbol IEC 60417-5307 (2002-10) (see Symbol 1 of Table C.1). The priority may be indicated by adding one, two or three optional elements, (e.g.! for LOW PRIORITY, !! for MEDIUM PRIORITY, and !!! for HIGH PRIORITY).
NOTE 1 Factors affecting the legibility of a visual indication include the nature and characteristics of the visual indication itself, ambient lighting in the intended environment of use, and viewing angle and distance.
NOTE 2 The use of text that flashes on and off is discouraged because it is often difficult to read. Flashing text that alternates between normal and reverse video or another colour is acceptable.
NOTE 3 Multiple-purpose computer-generated graphic displays should be designed in accordance with modern human interface design principles. Attention is drawn to IEG 60601-1-6 IEC 62366.
NOTE 4 The identification of the ALARM CONDITION is intended to convey information necessary for PATIENT safety and safe use of the equipment.AS IEC 60601.1.8 pdf free download.

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