AS 80601.2.30:2018 pdf free
AS 80601.2.30:2018 pdf free.Medical electrical equipment
Two samples of the AUTOMATED SPHYGMOMANOMETER of the same MODEL OR TYPE REFERENCE are needed to perform this test PROCEDURE.
NOTE At the beginning of this compliance test, neither sample has been subjected to the mechanical stress tests of the general standard and the collateral standards. Step h) subjects AUTOMATED SPHYGMOMANOMETER A to the stress tests, and the laboratory limits of the change in error of the BLOOD PRESSURE DETERMINATION are compared before and after these mechanical stresses.
a) Label one sample of the AUTOMATED SPHYGMOMANOMETER as A and the other sample as B.
b) Prior to performing the other tests of this document, adjust the PATIENT SIMULATOR to generate signals in such a way that the AUTOMATED SPHYGMOMANOMETER displays approximately a DIASTOLIC BLOOD PRESSURE value of 40 mmHg (5,3 kPa) and a SYSTOLIC BLOOD PRESSURE value of 70 mmHg (9,33 kPa) at a pulse rate of 140 beats/min in NEONATAL MODE and a DIASTOLIC BLOOD PRESSURE value of 80 mmHg (10,67 kPa) and a SYSTOLIC BLOOD PRESSURE value of 120 mmHg (16,0 kPa) at a pulse rate of 80 beats/min otherwise. Either sample of the AUTOMATED SPHYGMOMANOMETER may be used for this step.
If an AUTOMATED SPHYGMOMANOMETER has an ALARM SYSTEM that includes PHYSIOLOGICAL ALARM CONDITIONS,it shall be equipped with an ALARM SYSTEM that detects an ALARM CONDITION to indicate both a PHYSIOLOGICAL ALARM CONDITION for low BLOOD PRESSURE and a PHYSIOLOGICAL ALARM CONDITION for high BLOOD PRESSURE. These ALARM CONDITIONS shall be at least MEDIUM PRIORITY, unless an INTELLIGENT ALARM SYSTEM is utilized that uses additional physiological information to determine that these ALARM CONDITIONS are not true. These ALARM CONDITIONS may be for SYSTOLIC BLOOD PRESSURE， DIASTOLIC BLOOD PRESSURE,or MEAN ARTERIAL PRESSURE .
In NORMAL CONDITION in any automatic cycling mode of operation,a pressure relief PROTECTION DEVICE shall ensure that the CUFF shall not inflate above the values in Table 201.103 for more than 180 s, or in NEONATAL MODE 90 s. See Figure 201.103.
In SINGLE FAULT CONDITION, in any automatic cycling mode of operation, a pressure relief PROTECTION DEVICE, functioning independently of the NORMAL CONDITION PROTECTION DEVICE,shall ensure that the CUFF does not inflate above the values in Table 201.103 for more than 180 s, or in NEONATAL MODE 90 S. See Figure 201. 103.AS 80601.2.30 pdf free download.
