User's Manual

Rad-87 Pulse CO-Oximeter Operator’s Manual
7-3
7
Specifications
Display/Indicators
Type: LED
Display Language English (default)
Data display: %SpO
2
, %SpCO, %SpMet, SpHb g/dl, SpOC ml/dl, pulse rate, pleth variability index (PVI), RRa,
alarm status, status messages, Signal I.Q. (SIQ), acoustic Signal I.Q. (SIQa), perfusion index
(PI),Respiration Indicator (RI), sensitivity modes, wireless radio connection, system status light.
Display update rate: 1 second
Output Interface
Serial RS-232
Wireless Radio (if installed) 802.11 a/b/g
Nurse Call
Philips VueLink, RadNet, Patient SafetyNet
Compliance
Safety Standard for Medical Equipment
IEC 60601-1 2nd Edition
IEC 60601-2-49 1st 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 EN 60601-1-2
Wireless Radio (if installed)
Compatibility Standard
802.11 a/b/g
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 SpO
2,
SpCO and SpMet accuracy was determined by testing on healthy adult volunteers in the range 60% - 100% SpO
2,
0% - 40% SpCO and
0% - 15% SpMet against a laboratory CO-Oximeter. SpO
2
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 Fluke Biotek Index 2 simulator and Masimo's simulator with
signal strengths of greater than 0.02% and transmission of greater than 5% for saturations
and pulse rates within the stated accuracy specifications.
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.
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. SpHb accuracy has been validated on healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation in the
range of 8 g/dL to 17 g/dL SpHb against a laboratory CO-Oximeter. The variation equals plus or minus one standard deviation which encompasses
68% of the population. The SpHb accuracy has not been validated with motion or low perfusion.
10. Respiration rate accuracy for the Masimo Acoustic Respiration Sensor and Instrument has been validated for the range of 4 to 70 breaths per minute in
bench top testing. Clinical validation for up to 30 breaths per minute was also performed with the Masimo Acoustic Respiration Sensor and Instrument.