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50 Radical Signal Extraction Pulse Oximeter Operator’s Manual
7
specifications
compliance
EMC Compliance: EN60601-1-2, Class B
Equipment Classification: IEC 60601-1-1 / UL 2601-1
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
Enclosed Degree of Ingress Protection from Solids/Liquids: IPX1
Mode of Operation: Continuous
1
The Masimo SET Radical Pulse Oximeter with LNOP Adt 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
2
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.
2
The Masimo SET Radical Pulse Oximeter with LNOP Adt 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
2
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.
3
The Masimo SET Radical Pulse Oximeter with LNOP Neo and Neo Pt sensors has been validated for neonatal motion accuracy in
human blood studies on neonates while moving the neonates foot at 2 to 4 Hz at an amplitude of 1 to 2 cm against a laboratory co-
oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Pulse or minus one standard deviation
encompasses 68% of the population.
4
The Masimo SET Radical Pulse Oximeter with SatShare has been validated for low perfusion accuracy in bench top testing against a
Biotek Index 2 simulator and Masimos 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
This represents approximate run time with no backlight and Power Save mode, using a new, fully charged battery.
6
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.
7
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.
8
Maximum sensitivity mode fixes perfusion limit to 0.02%.
serial interface specifications
The digital interface for serial communication is based on the standard RS-232 protocol.
The Radical Pulse Oximeter by default always outputs ASCII1 text data through the serial
port, unless the user selects a different output mode in the Output menu. To interface with
the Radical and receive serial text data, simply connect a serial interface cable to the
serial output connector located on the back of the Radical Docking Station.
NOTE: The Radical serial interface is only available when the Radical Handheld is properly attached to the Radical
Docking Station.
NOTE: The serial interface is not available in all versions of the docking station.
Once serial communication is established, packets of data are communicated at 1 second
intervals. The data packets contain: the date, time, SpO
2
, pulse rate, perfusion index and
alarm and exception values. (in ASCII format).
WARNING: ALL EXTERNAL DEVICE CONNECTIONS TO THE ANALOG OUTPUT/
NURSE CALL CONNECTOR MUST BE IEC-60950 COMPLIANT.
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