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Radical-7R Pulse CO-Oximeter Operator’s Manual
7
of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of
70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus
o
r minus one standard deviation encompasses 68% of the population.
4 The Radical-7R has been validated for low perfusion accuracy in bench-top testing against a Fluke Biotek Index 2 simulator and
Masimo's simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations and pulse rates
within the stated accuracy specifications. This variation equals plus or minus one standard deviation. Plus or minus one standard
deviation encompasses 68% of the population.
5 Masimo sensors have been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index
2 simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
6 SpHb accuracy has been validated on healthy adult male and female volunteers and on surgical patients with light to dark skin
pigmentation in the range of 8 g/dL to 17 g/dL SpHb against a laboratory CO-Oximeter. The variation equals plus or minus one standard
deviation which encompasses 68% of the population. The SpHb accuracy has not been validated with motion or low perfusion.
7 Respiration rate accuracy for the Masimo Acoustic Respiration sensor and instrument has been validated for the range of 4 to 70
breaths per minute in bench top testing. Clinical validation for up to 30 breaths per minute was also performed with the Masimo Acoustic
Respiration sensor and instrument.
8 This represents approximate run time at the lowest indicator brightness and pulse tone turned off using a fully charged battery.
9 If the batteries are to be stored for extended periods of time, it is recommended that they be stored between -20°C to +30°C, and at a
relative humidity less than 85%. If stored for a prolonged period at environmental conditions beyond these limits, overall battery capacity
may be diminished, and lifetime of the batteries may be shortened.
10 With FastSat the averaging time is dependent on the input signal. For the 2 and 4 second settings the averaging time may range from
2-4 and 4-6 seconds, respectively.
11 Maximum sensitivity mode fixes perfusion limit to 0.02%.
Analog Output/Nurse Call Specifications
The Analog Out and Nurse Call features are accessible on a female high density DB-15 connector.
NOTE:
The Radical-7R Pulse CO-Oximeter analog output / nurse call interface is only available
when the Radical-7R Pulse CO-Oximeter Handheld is properly attached to the Radical-7R Pulse
CO-Oximeter Docking Station. Only use an analog / nurse call cable that has a ferrite bead installed.
NOTE:
The analog output / nurse call interface is not available in all versions of the Docking Station.
The following table shows the pinout of the analog output and nurse call.
PIN
SIGNAL NAME
1
Reserved
2
Ground
3
Ground
4
Ground
5
Ground
6
Nurse Call (Normally Open)
7
Nurse Call (Normally Closed)
8
Ground
9
Analog 1
10
Ground
11
Ground
12
Nurse Call – Common
13
Ground
14
Ground
15
Analog 2
S p e c i f i c a t i o n s
R a d i c a l - 7 R s p e c i f i c a t i o n s ( c o n t i n u e d )