Datascope Passport - Mindray

Appendix Performance Specifications
6.2.6.5 Maximum Leakage
6.2.6.6 Vent Rate
The maximum allowed pressure drop with the bleed valves closed is 10 mmHg in 10 seconds
as measured with a 500 cc volume at differential pressures of 250 mmHg, 150 mmHg and
50 mmHg (reference ANSI/AAMI SP10-1992, EN1060-3, 1997).
A volume of 500 cc, when vented, is reduced from a pressure of 260 mmHg to a pressure of
15 mmHg in a maximum of 10 seconds. For Neonate, from a pressure of 150 mmHg to a
pressure of 5 mmHg in less then 5 seconds (reference: EN1060-3, 1997).
6.2.7 NIBP Sub-System Functional Requirements
6.2.7.1 Initial Conditions
The NIBP System performs a zero calibration adjustment at power-up.
6.2.7.2 NIBP Starting Pressure Settings and Ranges
Range of Adjustment: Adult Patients, 100-280 mmHg
6.2.7.3 NIBP Measurement Cycle
Pediatric Patients, 60-180 mmHg
Neonatal Patients, 40-120 mmHg
Default Start Pressure: Adult Patients, 180 mmHg.
Pediatric Patients, 140 mmHg.
Neonatal Patients, 100 mmHg.
Pressure Increment: 5 mmHg, regardless of patient size.
There are two different modes of measurement operation: manual and interval modes. The
manual mode requires the operator to initiate the measurement cycle. The interval mode
follows a configured plan of automatically initiated measurement cycles.
The Maximum Measurement Cycle Duration shall be 180 sec for Adult and Pediatric patients
(reference EN601-2-30, 1995).
The Maximum Measurement Cycle Duration shall be 90 sec for Neonatal patients (reference
EN601-2-30, 1995).
During a measurement, if the initial cuff inflation pressure is found to be inadequate, the unit
shall retry with a higher inflation pressure (+50 ±10 mmHg in Adult and Pediatric modes and
+40 ±10 mmHg in Neonatal mode).
In interval mode only, the unit shall adjust the inflation pressure according to the previous
systolic pressure. After the first successful measurement is made, the subsequent inflation
pressure becomes +50 ±10 mmHg in the Adult and Pediatric modes and +40 ±10 mmHg in
Neonatal mode.
Passport 2®/Passport 2 LT Operating Instructions 0070-10-0649-01 6 - 13