Accutorr 7 Operator’s Manual
A - 11
A.7.4
Temp
Statistical Results of Clinical Investigation Data
A.8
CO
2
Standards
Meets standards of ASTM E1112, ASTM E1104, ISO 80601-2-
56
Technique
Thermal resistance (use thermistor to measure
temperature)
Measurement range
Monitor mode:25 to 44°C (77 to 111.2 °F)
Predictive mode: 35 to 43°C (95 to 109.4 °F)
Accuracy (Monitor mode)
25°C to 32°C (not include 32°C): ± 0.2°C
32°C to 44 °C (include 32°C): ±0.1°C
or
77°F to 89.6°F (not include 89.6°F): ± 0.4°F
89.6°F to 111.2°F (include 89.6°F): ± 0.2°F
Resolution
±0.1°C
Minimum measurement
time for accurate readings
Monitor mode: <60 s
Predictive mode: <20 s (typical test: < 12s )
Alarm limit
Range
Step
Temp High
(low limit +1) °C to 44°C
(low limit +1.8) °C to 111.2°F
0.1°C
0.2°F
Temp Low
25°C to (high limit -1) °C
77°F to (high limit -1.8) °F
Clinical BIAS (Δ cb)
Limits of Agreement
(LA)
Clinical
Repeatability (σr)
Oral
0.02
0.33
0.1
Axilla
0.06
0.38
0.13
Rectum
-0.05
0.48
0.14
Standard
Meets standard of ISO 80601-2-55
Technique
Infrared absorption
[
No CO2 Changes
Detected
] delay time
10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s
Measurement range
0 to 20% (0 to 150 mmHg)
Summary of Contents for Accutorr 7
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