| Four tests, using healthy volunteers at Masimo Corporation’s testing facility, were conducted to compare the latest generation pulse oximetry technologies. Three of these tests show false desaturations and false pulse rate indications with the Nellcor N-595 and N-395 pulse oximeters during motion. The last test demonstrates the response time of Masimo SET Radical with LNOP Ear Sensor as compared to the Nellcor N-595 with Max-Fast Reflectance Sensor through a desaturation. Both a Nellcor N-395 and Masimo SET oximeter were used as references throughout the testing. In all cases, it is apparent that Masimo SET outperformed the newer generation Nellcor N-595 as well as the N-395. It is also apparent that the Nellcor N-595 did not perform as well as their last generation N-395. |
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| From these tests, it is demonstrated that: |
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1. |
Masimo SET performs significantly better than either the N-595 or N-395 devices. |
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2. |
The newer generation N-595 does not perform as well as the older generation N-395. |
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3. |
The N-595 claims of being ‘faster’ with forehead reflectance sensors is not substantiated, as shown in test 4. |
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| Test 1: Masimo SET vs. Nellcor N-595 and N-395 - Random Motion with Desaturation (Click here to
see the video.) |
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| A Masimo SET Radical and a Nellcor N-395 are used on the left
hand as a reference. A Masimo SET Radical, Nellcor N-595 and a Nellcor N-395 are
on the test (right) hand and the subject moves her hand in random motion. Within
one minute the Nellcor N-595 on the test hand displays a false desaturation of
88% as compared to the reference at 100%, going down to 67% approaching two
minutes. After a total of three minutes, the Nellcor N-395 on the test hand
displays a false desaturation of 84% as compared to the reference at 100%.
During the entire test, the Masimo SET on the test hand tracks closely the
reference pulse oximeters on non-motion hand. Click here to
see the plot. |
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| Test 2: Masimo SET vs. Nellcor N-595 and N-395 - Random Scratching, Room Air (Click here to see
the video.) |
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| In the same test setup, the subject moves her hand and scratches in random
frequency. The Nellcor N-395 on the test hand displays an initial false
desaturation. After a total of one minute, the Nellcor N-595 on the test
hand displays a false high pulse rate of over 130 BPM as compared to the
reference of 60 BPM. The Nellcor N-395, during the same time period, displays
a false desaturation. After an additional few seconds, the Nellcor N-595
on the test hand displays a false desaturation of 83% as compared to the
reference at 100%. The Masimo SET on the test hand tracks closely with
the reference hand during the entire test. Click here to see the plot. |
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| Test 3: Masimo SET vs. Nellcor N-595 and N-395 - t=0 Sensor Connected during Random Tapping and Desaturation (Click here to see the video.) |
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| The sensors on the test hand are connected to the various pulse
oximeters. To simulate what happens if pulse oximeters are connected to a
patient while the patient is agitated or moving, the subject is asked to move
and then the pulse oximeters are turned on. The Nellcor N-595 and Nellcor N-395
on the test hand fail to establish a SpO2 or pulse reading, while Masimo SET
provides measurement that correspond with the reference hand. Within the first
minute, the Nellcor N-595 panel displays a message that the sensor is off. After
a total of 3 minutes and 5 seconds, random tapping is stopped. Within 10
seconds, the Nellcor N-595 and Nellcor N-395 on the test hand display values.
Within 20 seconds, the Nellcor N-395 on the test hand displays numbers
approximating the reference hand. Within 30 seconds, the Nellcor N-595 on the
test hand displays numbers approximating the reference hand. The Masimo SET on
the test hand tracks the reference hand during the entire test after the initial
acquisition. Click here to see the plot. |
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| Test 4: Response Time: Masimo SET Radical with LNOP Ear Sensor Vs. Nellcor N-595
with Max-Fast Reflectance Sensor and Desaturation (Click here to see the
video.) |
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| The test subject who has low perfusion experiences a
desaturation and within 30 seconds, Masimo SET with the LNOP Ear Sensor starts
to display that desaturation. Approximately ten seconds later, the Nellcor N-595
with the Max-Fast Reflectance Sensor starts to display a desaturation. After a
total of one minute and fifteen seconds, the desaturation is concluded. Within
eleven seconds of the conclusion, Masimo SET responds to that event, while the
Nellcor N-595 took approximately 16 seconds to respond to the event. The digit
sensors lagged both the LNOP Ear Sensor and the Max-Fast reflectance sensor by
over a minute due to physiology of low perfusion. Click here to see the plot. |
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| Click here to see white papers. |