Datascope Passport - Mindray

Appendix Performance Specifications
Optionally, non-lethal or all arrhythmia alarms are capable of being disabled.
In 3 Lead and 5 Lead ECG modes: PVCs per minute are invalidated and the PVC counter
is reset to 0 during periods of Ventricular Rhythm, Ventricular Tachycardia, Ventricular
Fibrillation or Asystole.
In 12 Lead ECG mode: PVCs per minute are invalidated and the PVC counter is reset to 0
during periods of Ventricular Rhythm, Ventricular Tachycardia, and Ventricular Fibrillation.
During periods of Asystole, the PVC counter is reset to 0.
6.2.5.1 12-Lead ECG Interpretation
The Passport 2, equipped with optional 12-Lead ECG, has the ability to make
Interpretation, Rhythm and Condition statements in accordance with the Physician’s Guide to
Computerized ECG Analysis (Mindray DS P/N 0070-00-0524-01 English, 0070-00-0524-
50 all other languages).
Interpretive statements are disabled in neonatal and pediatric modes.
Interpretive statements are disabled in adult mode for ages less than 18 years old.
6.2.6 NIBP Sub-System Performance Characteristics
This function calculates the patient blood pressure non-invasively, using a blood pressure cuff.
There are three pressure readings available: systolic, diastolic, and mean pressures.
Systolic Pressure Measurements
Accuracy 1,2 : Mean error is less than ± 5 mmHg
Diastolic Pressure Measurements
Standard Deviation shall be less than ± 8
mmHg.
Range: 55 to 235 mmHg in Adult mode
55 to 160 mmHg in Pediatric mode.
45 to 120 mmHg in Neonatal mode.
Accuracy 1,2 : Mean error is less than ± 5 mmHg,
Standard deviation is less than ± 8 mmHg.
Range: 30 to 200 mmHg in Adult mode
30 to 150 mmHg in Pediatric mode.
20 to 100 mmHg in Neonatal mode.
1Adult and Pediatric - Blood pressure measurements determined with this device are
equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation
method, within the limits prescribed by the American National Standard, Electronic or
automated sphygmomanometers.
Passport 2®/Passport 2 LT Operating Instructions 0070-10-0649-01 6 - 11