Fukuda Denshi DynaScope 7000 Series, Operation Manual

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NIBP (Non-Invasive Blood Pressure)
(IEC 60601-2-30: 1999 Medical electrical equipment- Part 2: Particular requirements for the
safety of automatic cycling indirect blood pressure monitoring equipment)
(EN 60601-2-30: 2000 Medical electrical equipment- Part 2: Particular requirements for the
safety of automatic cycling indirect blood pressure monitoring equipment)
(AAMI SP10: 2002+A1:2003+A2:2006 Manual, electronic or automated sphygmomanometers)
Method : Oscillometric Method
Measurement Range : Adult 10 to 280 mmHg/1.3 to 37.3kPa
Child 10 to 180mmHg/1.3 to 24.0kPa
Neonate 10 to 130mmHg/1.3 to 17.3kPa
Resolution : 1mmHg
Static Pressure Accuracy :
±
3 mmHg/0.4kPa
Accuracy
Maximum Standard Deviation : 8mmHg/1.0kPa
Maximum Average Error
:
±
5mmHg/0.6kPa
PR Measurement Range : 40 to 240bpm
±
2% or
±
2bpm (whichever greater)
Deflation Speed : 5 ± 1mmHg/sec (Quick Measurement OFF)
10
±
2mmHg/ sec (Quick Measurement ON)
Safety Mechanism : Adult 300mmHg or above
Child 210mmHg or above
Neonate 150mmHg or above
Gas Concentration (Multigas Unit: MGU-701/MGU-702, optional)
The performance is according to the Criticare Systems Inc. OEM HIGH IQ
TM
AGENT MODULE
specification.
Method : Sidestream; Non-dispersive infrared (NDIR)
Identified Gases : CO
2
, N
2
O, O
2
, Halothane, Enflurane, Isoflurane, Desflurane, and
Sevoflurane
Flow Rates : 100mL/min, 150mL/min, 200mL/min
Measurement Range : CO
2
0 to 12.5% (0 to 99mmHg, 0 to 12kPa)
N
2
O 0 to 99%
O
2
0 to 100%
Halothane: 0 to 10%
Enflurane: 0 to 10%
Isoflurane: 0 to 10%
Sevoflurane: 0 to 10%
Desflurane: 0 to 20%
RR 1 to 60 Bpm
Accuracy : CO
2
: ± 0.2% abs. or 4% of reading
N
2
O:
±
(1.5% abs. +4% of reading)
O
2
:
±
3 vol. % (0 to 90%)
± 4 vol. % (91 to 100%)
Agents:
±
(0.1% abs. +4% of reading)
RR:
±
2 Bpm or 2% of reading
Time to Detect Agent <15 second@200mL/min
Agent Detection
Resolution
: 0.1 Volume Percent
Detection Threshold : Halothane 0.2 vol. %
Enflurane 0.3 vol. %
Isoflurane 0.3 vol. %
Sevoflurane 0.3 vol. %
Desflurane 0.3 vol. %
Mixed Gas Threshold : 0.2 vol. % + 10 % of total concentration
Rise Time
: CO
2
: 350msec
N
2
O: 400msec
O
2
: 600msec
Agents: 450msec
Occlusion Clearing : Automatic
Auto Zeroing : Occurs 30 to 60 minutes
Duration: 3.0 to 7.0 seconds
Manual user calibration not required
Warm-up Time : 1 minute to first waveforms
<20 minutes to full accuracy