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Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual 7-3

Specifications

Sensor condition, system failure and low battery alarms

High Priority:

571 Hz tone, 5 pulse burst, pulse spacing: 0.250s,

0.250s, 0.500s, 0.250s, repeat time:10s

Medium Priority:

550 Hz tone, 3 pulse burst, pulse spacing: 0.375s,

0.375s, repeat time: 7s

Low Priority: 500 Hz tone, 1 pulse burst, repeat time: 5s

Alarm Muted reminder:

500Hz tone, 2 pulse burst, pulse spacing 0.375s,

repeat time: 3min.

Alarm Volume:

High Priority: 70 dB (min),

Medium Priority: 70 dB (min),

Low Priority: 45 dB (min)

Display/Indicators

Data display: %SpO

, %SpCO, %SpMet, SpHb g/dl, SpOC

ml/dl, PVI, pulse rate, plethysmographic

waveform, alarm status, trends, status messages, Signal IQ, perfusion index, APOD and

FastSat

Display update rate: 1 second

Response Time: < 20 second delay

Type: Backlit Active Matrix TFT LCD

Pixels: 480 x 272 dots

Dot Pitch: 0.25 mm

Output Interface

SatShare (RDS-1, RDS-1B)

Serial RS-232 (RDS-1, RDS-1B, RDS-3)

Nurse Call/Analog Output (RDS-1, RDS-1B, RDS-3)

Philips Vuelink, Spacelabs Universal Flexport, RadNet, Patient SafetyNet (RDS-1, RDS-1B, RDS-3)

Compliance

EMC Compliance: EN60601-1-2, Class B

Equipment Classification: IEC 60601-1 / UL 60601-1

Type of Protection Class 1 (on AC power), Internally powered (on battery power)

Degree of Protection-Patient Cable: Type BF-Applied Part

Degree of Protection-SatShare Cable: Type CF-Applied Part

Mode of Operation: Continuous

1 SpO

SpCO and SpMet accuracy was determined by testing on healthy adult volunteers in the range 60% - 100% SpO

0% - 40%

SpCO and 0% - 15% SpMet against a laboratory CO-Oximeter. SpO

and SpMet accuracy was determined on 16 neonatal NICU

patients ranging in age from 7 to 135 days old and weighting between 0.5 and 4.25 kgs. Seventy-nine (79) data samples were collected

over a range of 70 - 100% SaO

and 0.5 - 2.5% HbMet with a resultant accuracy of 2.9% SpO

and 0.9% SpMet. Contact Masimo

for testing speciations.

2 The Masimo Rainbow SET technology with Masimo sensors has been validated for no motion accuracy in human blood studies on

healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of 70-100% SpO

against a laboratory CO-Oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one

standard deviation encompasses 68% of the population weight.

The Masimo Rainbow SET technology with Masimo sensors has been validated for motion accuracy in human blood studies on

healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies while performing rubbing and

tapping motions, at 2 to 4 Hz at an amplitude 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% SpO

against a laboratory CO-Oximeter and ECG monitor. This variation equals

plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.

Radical-7 Specifications (continued)

1 2 ... 88 89 90 91 92 93 94 95 96 97 98 ... 115 116

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