Masimo Radical Signal Extraction Manual do Operador descarregar pdf (Página 42)

7-2 Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual Radical-7 Color Display Signal Extraction Pulse Oximeter Operator’s Manual 7-37-3

specifications

Display/Indicators

Data display: %SpO

, %SpCO, %SpMet, pulse rate, pleth waveform, alarm status, trends, status mes-

sages, Signal IQ, perfusion index, APOD and FastSat

Display update rate: 1 second

Display Color: Multi-color

Ty p e : Backlit 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, RadLink (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 The Radical-7 with LNOP Adt 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

Pulse 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 Radical-7 with LNOP Neo 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

Pulse CO-Oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard devia-

tion encompasses 68% of the population weight. 1% has been added to the saturation accuracy to account for the effects of fetal

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

The Radical-7 with LNOP Adt 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 Pulse 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.

4 The Radical-7 with SatShare 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. Plus or minus one standard deviation encompasses 68% of

the population.

5 SpCO and SpMet accuracy has been validated on healthy adult male and female volunteers with light to dark skin pigmentation in

the range of 0% - 40% SpCO and 0% - 15% SpMet against a laboratory Pulse CO-Oximeter. This variation equals plus or minus one

standard deviation, which encompasses 68% of the population. The SpCO accuracy and SpMet accuracy have not been validated

under motion conditions.

6 This represents approximate run time with the backlight at minimum and Power Save mode on, using a new, fully charged battery.

7 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.

8 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.

9 Maximum sensitivity mode fixes perfusion limit to 0.02%.

10 Masimo Rainbow SET technology with LNOP, LNOPv and LNCS sensors has 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.

Docking Station (RDS-1B):

Type: NiMH

Capacity: 10 hours

Charging time: 6 hours

ENVIRONMENTAL

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

Storage Temperature: -40°F to 158°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:

Handheld: 8.9” x 3.3” x 2.1” (22.6 cm x 8.4cm x 5.3 cm)

Standalone: 3.5” x 10.5” x 7.7” (8.9 cm x 26.7cm x 19.6cm)

Weight

Handheld: 1.3 lbs. (0.59 kg)

Docking Station (RDS-1, RDS-2, RDS-3): 2.5 lbs. (1.14 kg)

Docking Station (RDS-1B): 4.11 lbs (1.86 kg)

Standalone (RDS-1, RDS-2, RDS-3): 3.8 lbs. (1.73 kg)

Standalone (RDS-1B): 5.4 lbs. (2.45 kg)

Trending

72 hours of trending at 2 second resolution, up to 18 days of trending at 10 second resolution, output to

serial printer or other serial devices

Mode

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

Sensitivity: Normal and 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, SpCO 1%-99%, SpMet 1%-99.9%)

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)

specifications

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