Specifications
A-10
www.zoll.com
9650-000820-01 Rev. K
Environmental:
Operating Temperature: 0
º
to 50
º
C (32
º
to 122
º
F)
Storage Temperature: -40
º
to 70
º
C (-40
º
to 158
º
F)
Electromagnetic Immunity (SpO
2
Option Only):
AAMI DF-80; EN61000-4-3:2002 to 10 V/m
Notes
:
•
SpO
2
, SpCO and SpMet accuracy was determined by testing on healthy adult volunteers in
the range of 60-100% Sp0
2
, 0-40% SpCO, and 0-15% SpMet against a laboratory CO-
Oximeter. Sp0
2
and SpMet accuracy was determined on 16 neonatal NICU patients ranging
in age from 7-135 days old and weighing between 0.5-4.25 kg. Seventy-nine (79) data
samples were collected over a range of 70-100% Sa0
2
and 0.5-2.5% MetHb with a resultant
accuracy of 2.9% SpO
2
and 0.9% SpMet.
•
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.
•
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 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 which encompasses
68% of the population.
•
The Masimo 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 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.
•
The 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.
•
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 8-17 g/dl SpHb against
a laboratory CO-oximeter. This 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.
•
The following substances may interfere with pulse CO-Oximetry measurements:
•
Elevated levels of Methemoglobin (MetHb) may lead to inaccurate SpO
2
and SpCO
measurements
•
Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO
2
measurements.
•
Very low arterial Oxygen Saturation (SpO
2
) levels may cause inaccurate SpCO and
SpMet measurements.
•
Severe anemia may cause erroneous SpO
2
readings.
•
Dyes, or any substance containing dyes, that change usual blood pigmentation may cause
erroneous readings.
•
Elevated levels of total bilirubin may lead to inaccurate SpO
2
, SpMet, SpCO and SpHb
readings.