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7-2 Rad-57 Signal Extraction CO-Pulse Oximeter Operator’s Manual

Rad-57 Signal Extraction CO-Pulse Oximeter Operator’s Manual 7-3

specifications specifications

Masimo Rainbow SET technology with LNOP, LNOPv and LNCS sensors has been validated for no motion

accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70-100%

SpO

against a laboratory CO-Oximeter and ECG monitor. 1% was added to account for the properties of

fetal hemoglobin. This variation equals plus or minus one standard deviation which encompasses 68% of the

population.

Masimo Rainbow SET technology with LNOP, LNOPv and LNCS sensors has been validated for motion accuracy

in human blood studies on healthy adult volunteers 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 which encompasses 68% of the population.

Masimo Rainbow SET technology has been validated for low perfusion accuracy in bench top testing against a

Biotek Index 2 simulator and Masimo’s simulator with signal strengths of greater than 0.02% and a % transmission

of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard

deviation which encompasses 68% of the population.

This represents approximate run time at lowest indicator brightness, using a new, fully charged battery.

If alkaline batteries are to be stored for extended periods of time, it is recommended that they be stored between

-0°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.

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.

SpCO accuracy has been validated on healthy adult volunteers against a laboratory co-oximeter. This variation

equals plus or minus one standard deviation which encompasses 68% of the population. The SpCO accuracy has

not been validated under motion conditions.

ELECTRICAL

Batteries

Type: 4 “AA” Alkaline

Capacity: over 8 hours

Isolation: No external power or ground connection, internally powered only.

ENVIRONMENTAL

Operating Temperature: 41°F to 104°F (5°C to 40°C)

Storage Temperature: -40°F to 158s°F (-40°C to +70°C)

Operating Humidity: 5% to 95%, non-condensing

Operating Altitude: 500 mbar to 1060 mbar pressure,

-1000 ft to 18,000 ft (-304 m to 5,486 m)

PHYSICAL CHARACTERISTICS

Dimensions: 6.2” x 3.0” x 1.4” (15.8 cm x 7.6cm x 3.6 cm)

Weight: 13oz. (0.32 kg)

SpO

Modes

Averaging mode: 2, 4, 8,10, 12, 14 or 16 seconds

Sensitivity: Normal, Maximum and APOD

Alarms

Audible and visual alarms for high low saturation and pulse rate

(SpO

range 1-100%, pulse rate range 25-240 bpm and SpCO %5 - %50)

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

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

Display/Indicators

Data display: %SpO

, %SpCO, SpCO bar, pulse rate, alarm status, alarm silenced status,

Perfusion Index (PI) / pleth bar, Low Signal IQ, battery status and SpCO connected.

Type: LED

Display update rate 1 second

Compliance

EMC Compliance: EN60601-1-2, Class B

Equipment Classification: IEC 60601-1-1

Type of Protection: Internally powered (on battery power)

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

Mode of Operation: Continuous

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Masimo Radical Signal Extraction Manuale dell'Operatore Pagina 23

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