Masimo Rad-87, Руководство оператора

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Rad-87 Pulse CO-Oximeter Operator’s Manual 7-3 7-3
7
s p e c i f i c a t i o n s
Compliance
Safety Standard for Medical Equipment FCC ID: VKF-RAD87 IEC 60601-1 2nd Edition
UL 60601-1
CAN/CSA C22.2 No. 601-1
JIS 0601-1
Type of Protection Class 1 ( AC power) Internally powered ( battery power)
Degree of Protection (Pulse CO-Oximeter Cable): Type BF, Defib Proof (Applied-Part)
Mode of Operation: Continuous
EMC Standard 60601-1-2
Radio
USA FCC ID VKF-RAD87
FCC parts 15.247 and 15.407
Canada IC ID 7362A-RAD87
RSS-210
Europe EN 300328
EN 301893
EN 301489-17
1 SpO2, SpCO and SpMet accuracy was determined by testing on healthy adult volunteers in the range 60% - 100% SpO2, 0% - 40%
SpCO and 0% - 15% SpMet against a laboratory CO-Oximeter. SpO2 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% SaO2 and 0.5 - 2.5% HbMet with a resultant accuracy of 2.9% SpO
2
and 0.9% SpMet. Contact Masimo
for testing specifications.
2 The Masimo sensors have 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
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 sensors have 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
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.
4 The Rad-87 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 transmission of greater than 5% for saturations ranging from 70-100%. 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 This represents approximate run time at the lowest indicator brightness and pulse tone turned off using a fully charged battery without
radio power.
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.
*Registered trademark of Fluke Biomedical Corporation, Everett, Washington.
PHYSICAL CHARACTERISTICS (CONTINUED)