User Manual for Vital Signs Monitor
38
Additional declarations to conform the particular standard of IEC 60601-2-27 “Medical
electrical equipment – Part 2-27: Particular requirements for the safety, including essential
performance, of electrocardiographic monitoring equipment”
Direct current for
respiration, leads-off
sensing, and active noise
suppression
Applied current less than 0.1 microamperes.
Response to irregular
rhythm
A1 Ventricular bigeminy-80BPM
A2 Slow alternating ventricular bigeminy-60BPM
A3 Rapid alternating ventricular bigeminy-120BPM
A4 Bidirectional systoles-90BPM
Time to ALARM for
tachycardia
Waveform B1, Amplitude
0.5 mV
1 mV
2mV
Average Time to Alarm
<8 sec
<8 sec
<8 sec
Waveform B2, Amplitude
1mV
2mV
4mV
Average Time to Alarm
<8 sec
<8 sec
<8 sec
6.2 TEMP Monitoring
1. TEMP measuring range: 21.0
℃
~50.0
℃
2. TEMP measuring accuracy: not greater than 0.2
o
C for TEMP measuring range from 25.0
o
C~45.0
o
C
3. TEMP responding time:
≤
150s
6.3 NIBP Monitoring
1. Measuring method: Oscillometric Technique
2. Pneumatic pressure measuring range: 0 mmHg~300mmHg
3. Accuracy of pressure measurement: ±3 mmHg
4. Cuff inflation time: <10 seconds (typical adult cuff)
5. Measurement time on the average: < 90 seconds
6. Air release time while the measurement is canceled:
≤
2 seconds (typical adult cuff)
7. Initial cuff inflation pressure
Adult: 175 mmHg
Infant: 135 mmHg
Neonate: 65 mmHg
8. Overpressure protection limit
Adult:
≤
300 mmHg
Infant:
≤
240mmHg
Neonate:
≤
150 mm
9. NIBP measurement range:
press
(
unit
)
Adult
Infant
Neonate
SYS
mmHg
40~255
40~200
40~135
MAP
mmHg
20~215
20~165
20~110
DIA
mmHg
10~195
10~150
10~95
10. NIBP accuracy:
Maximal mean difference: ±5 mmHg
Maximal standard deviation: 8 mmHg
Measurement mode: Manual, Auto, STAT