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Chapter 15: Specifications
This chapter contains specifications of Root.
For information on the specifications of Radical-7, Radius-7, MOC-9 modules, and standalone
devices, see Directions for Use or Operator's Manuals for these devices.
Measurement Accuracy
NIBP
Pressure Transducer
Between 0 mmHg and 300 mmHg ±3mmHg
Optional Integrated Temperature*
Temperature
Between 80°F and 110°F
(26.7°C and 43.3°C)
All patient populations ±0.2°F
(0.11°C)**
Temperature
Measurement Site/Mode
Number of
Subjects
Clinical
Bias (°C)
Limits of
Agreement
Clinical
Repeatability
Oral 106 0.01 0.63 0.14
Rectal 105 -0.12 0.59 0.29
Pediatric Axillary 117 -0.03 0.56 0.14
Adult Axillary 105 0.13 0.43 0.14
*Test Report #:2010036 Test Report of Clinical Investigation to demonstrate that the
SureTemp® Plus thermometer meets the essential performance of clinical thermometers for
body temperature measurement as described in ISO 80601-2-56:2009
**Applicable to Continuous Mode only. See Operation - Temperature on page 89.
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