Chapter 15: Specifications; Measurement Accuracy - Masimo Root Operator's Manual

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)
Temperature
Measurement Site/Mode
Oral
Rectal
Pediatric Axillary
Adult Axillary
*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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All patient populations
Number of Clinical
Subjects Bias (°C)
106 0.01
105 -0.12
117 -0.03
105 0.13
133
±0.2°F
(0.11°C)**
Limits of Clinical
Agreement Repeatability
0.63 0.14
0.59 0.29
0.56 0.14
0.43 0.14
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