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MOCACuff essential performance per IEC 80601-2-30 additional
essential performance requirements:
• 201.12.1.102 Limits of the error of the manometer from
environmental conditions
Over the temperature range of 5 °C to 40 °C (41 °F ~ 104
°F) and the relative humidity range of 15 % to 93 %
(non-condensing), the maximum error for the
measurement of the CUFF pressure at any point of the
NOMINAL measurement range shall be less than or
equal to ± 3 mmHg (± 0.4 kPa) or 2 % of the reading,
whichever is greater.
• 201.12.1.107 Limits of the change in error of the blood
pressure determination
The laboratory limits of the change in error of the
BLOOD PRESSURE DETERMINATION of the
AUTOMATED SPHYGMOMANOMETER shall be less
than 3 mmHg (0.4 kPa).
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