Philips EarlyVue VS30 - NBP Specifications

NBP Specifications
16-4 EarlyVue VS30 Instructions for Use
NBP Specifications
Oscillometric NBP Measurement
This monitor uses the oscillometric method for measuring NBP. In adult and pediatric
mode, the blood pressure measurements determined with this device comply with the
non-invasive sphygmomanometers part 2 clinical validation of automated measurement
type (ISO 81060-2:2013) in relation to mean error and standard deviation, when
compared to intra-arterial or auscultatory measurements (depending on the
configuration) in a representative patient population. For the auscultatory reference, the
fifth Korotkoff sound was used to determine the diastolic pressure.
In neonatal mode, the blood pressure measurements determined with this device comply
with the non-invasive sphygmomanometers part 2 clinical validation of automated
measurement type (ISO 81060-2:2013) in relation to mean error and standard deviation,
when compared to intra-arterial measurements in a representative patient population.
The NBP measurement is suitable for use in the presence of electrosurgery and during
the discharge of a cardiac defibrillator according to IEC 80601-2-30:2013/EN 80601-2-
30:2014.
The Philips NBP parameter module was evaluated against the auscultatory reference
method following the requirements of the ANSI/AAMI SP10:2002, IEC 81060-2:2013, and
EN1060-4:2004 standards. The NBP parameter was tested under clinical conditions on
pregnant women to ensure its accuracy in this patient population. For the auscultatory
reference, the fifth Korotkoff sound was used to determine the diastolic pressure.
Patients with pre-eclampsia were not explicitly addressed in this study nor were they
excluded.
Thermal
Operating
Temperature
Storage
Temperature
10° C to 40° C (50° F to 104° F) monitor
16°C to 40°C (60.8°F to 104°F) monitor with temporal
thermometer
–20° C to 50°C (–4° F to 122° F) monitor
–20° C to 40°C (–4° F to 104° F) monitor with accessories
Humidity, Operating
and Storage
Composite test range 10% to 90% RH (non-condensing) for
monitor
Composite test range 10% to 80% RH for monitor with print
recorder and paper
Altitude, Operating
and Storage
0 m to 3,000 m (0 ft to 9,842 ft) above sea level
1,013 mbar to 701 mbar (101 kPa to 70 kPa)
Electromagnetic
Compatibility
Meets the IEC 60601-1-2:2014/EN 60601-1-2:2015 standard
Parameter Specification