ANSI AAMI ISO 81060-2 pdf free download

ANSI AAMI ISO 81060-2 pdf free download.Non-invasive sphygmomanometers—Part 2: Clinical investigation of intermittent automated measurement type.
5.2.5 * Additional requirements for a SPHYGMOMANOMETER intended for use in exercise stress testing environments
a) For a SPHYGMOMANOMETER intended for use in exercise stress testing, an additional CLINICAL INVESTIGATION shall be performed.
1) During this CLINICAL INVESTIGATION, the subjects shall be stressed by dynamic (aerobic) exercise on a bicycle ergometer so as to increase their heart rate to at least 30 % above their resting heart rate.
2) The resting heart rate shall be recorded.
3) The heart rate for each DETERMINATION shall be recorded.
4) Any ami used for the REFERENCE reading and DETERMINATION shall be supported.
5) The CUFF shall be at the level of the left ventricle during the REFERENCE reading and DETERMINATION of BLOOD PRESSURE.
b) Any one of the CLINICAL INVESTIGATION methods descnbed in 5.2.4 may be used.
1) The CLINICAL INVESTIGATION shall consist of a minimum of 35 subjects.
2) A stress testing study shall be exempt from the requirements of 5.1.1, 5.1.3, 5.1.4 and 5.1.5.
3) At least 10 % of the subjects shall have a resting SYSTOLIC BLOOD PRESSURE 140 mmHg (18,66 kPa).
4) An exercise stress monitoring study need not be evaluated with acceptance criterion 2 of 5.2.4.1.2 or
5.2.4.2.2.
c) For the same arm sequential method of 5.2.4.1 replace the REFERENCE BLOOD PRESSURE variation exclusion criteria of 5.2.4.1.1 n)with the following:
1) Data from the subject shall be excluded, if any two sequential:
i) REFERENCE SYSTOLIC BLOOD PRESSURE readings differ by more than 8 mmHg (1,07 kPa); or
ii) any two sequential REFERENCE DIASTOLIC BLOOD PRESSURE readings differ by more than 6 mmHg (0,80 kPa).
2) The subject need not be excluded from the CLINICAL INVESTIGATION, but the series of REFERENCE readings and DETERMINATIONS may be continued.
3) The initial resting REFERENCE reading and DETERMINATION need not be repeated.
Check compliance by inspection of the CLINICAL INVESTIGATION REPORT.
5.2.6 * Additional requirements for a SPHYGMOMANOMETER intended for use in ambulatory monitoring
a) For a SPHYGMOMANOMETER intended for use in ambulatory monitoring, an additional CLINICAL INVESTIGATION shall be performed.
1) During this CLINICAL INVESTIGATION, the subjects shall be stressed by dynamic (aerobic) exercise on a bicycle ergometer so as to increase their heart rate to at least 15 % above their resting heart rate.
2) The resting heart rate shall be recorded.
3) The heart rate for each DETERMINATION shall be recorded.
4) During the REFERENCE reading and the SliT DETERMINATION any elbow and forearm shall be supported.
5) The CUFF shall be at the level of the left ventricle during the REFERENCE reading and DETERMINATION of BLOOD PRESSURE.
b) Any one of the CLINICAL INVESTIGATION methods described in 5.2.4 may be used.
1) The CLINICAL INVESTIGATION shall consist of a minimum of 35 subjects.
2) An ambulatory monitoring study shall be exempt from the requirements of 5.1 .1, 5.1.3, 5.1.4 and 5.1.5.
3) At least 30 % of the subjects shall have a resting SYSTOLIC BLOOD PRESSURE >140 mmHg (18,66 kPa).
4) An ambulatory monitoring study shall be exempt from the acceptance criterion 2 of 5.2.4.1.2 or 5.2.4.2.2.
C) For the same arm sequential method of 5.2.4.1, replace the REFERENCE BLOOD PRESSURE variation exclusion criteria of 5.2.4.2.1 with the following:
1) Data from the subject shall be excluded, if any two sequential:
i) REFERENCE SYSTOLIC BLOOD PRESSURE readings differ by more than 8 mmHg (1,07 kPa); or
ii) REFERENCE DIASTOLIC BLOOD PRESSURE readings differ by more than 6 mmHg (0,80 kPa).
2) The subject need not be excluded from the CLINICAL INVESTIGATION, but the series of REFERENCE readings and DETERMINATIONS may be continued.
3) The initial resting REFERENCE reading and DETERMINATION need not be repeated.
Check compliance by inspection of the CLINICAL INVESTIGATION REPORT.ANSI AAMI ISO 81060-2 pdf download.