8
9357F-eIFU-1117
D) Reattachment
• The sensor may be reapplied to the same patient if the emitter and detector windows are clear and the adhesive still
adheres to the skin.
• If the adhesive no longer adheres to the skin, use a new sensor.
NOTE:
When changing application sites, or reattaching sensor, first disconnect the sensor from the patient cable.
E) Disconnecting the Sensor from the Patient Cable
1. Refer to
Fig. 6
. Pull firmly on the sensor connector to remove it from the patient cable.
NOTE:
To avoid damage, pull on the sensor connector, not the cable.
SPECIFICATIONS
When used with Masimo rainbow SET technology monitors or with licensed Masimo rainbow SET technology modules using
RD rainbow SET Series patient cables, the sensors are intended for the following performance specifications:
RD rainbow SET-2 Sensor:
Adt
Pdt
Inf
Neo
Weight Range
> 30 kg
10 - 50 kg
3 - 10 kg
10 - 30 kg
< 3 kg
7
> 30 kg
Application Site
Finger
Finger
Thumb or
Great Toe
Finger
or Toe
Hand
or Foot
Finger
SpO
2
Accuracy, No Motion
1
,
(70 - 100%)
2%
2%
2%
2%
2%
2%
SpO
2
Accuracy, No Motion
1
,
(60 - 80%)
3%
3%
3%
3%
---
3%
SpO
2
Accuracy, Motion
2
3%
3%
3%
3%
3%
3%
SpO
2
Accuracy, Low Perfusion
3
2%
2%
2%
2%
2%
2%
Pulse Rate Accuracy, No Motion
4
3 bpm
3 bpm
3 bpm
3 bpm
3 bpm
3 bpm
Pulse Rate Accuracy, Motion
4
5 bpm
5 bpm
5 bpm
5 bpm
5 bpm
5 bpm
Pulse Rate Accuracy, Low Perfusion
4
3 bpm
3 bpm
3 bpm
3 bpm
3 bpm
3 bpm
SpMet Accuracy, No Motion
5
1%
1%
1%
1%
1%
1%
SpHb Accuracy, No Motion
6
1 g/dL
1 g/dL
1 g/dL
1 g/dL
---
1 g/dL
NOTE:
The table indicates Arms Accuracy which is calculated based upon measurement values that are statistically
distributed; approximately 68% of the measured values fell /- the Arms value when compared to the reference device
under a controlled study.
1
The Masimo SET technology has been validated for no motion accuracy in human blood studies on healthy adult male and female
volunteers with light to dark pigmented skin in induced hypoxia studies in the range of 60%-100% SpO
2
against a laboratory
co-oximeter.
2
The Masimo SET technology has been validated for motion accuracy in human blood studies on healthy adult male and female
volunteers with light to dark pigmented skin 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.
3
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%.
4
The Masimo SET technology has been validated for pulse rate accuracy for the range of 25-240 bpm 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%.
5
SpMet accuracy was determined by testing on healthy adult volunteers with light to dark skin pigmentation in the range of
0% - 15% MetHb against a laboratory CO-Oximeter.
6
SpHb accuracy, against that of a Coulter Counter, was determined by testing healthy adult volunteers with light to dark skin
pigmentation in the range 8 to 17 g/dL.
7
SpO
2
and SpMet accuracy for neonates was determined on 16 neonatal NICU patients ranging in age from 7 to 135 days old and
weighing between 0.5 and 4.25 kgs. Seventy-nine (79) convenience data samples were collected over a range of 70-100% SaO
2
and
0.5 - 2.5% MetHb with a resultant neonatal accuracy of 2.9% SpO
2
(1 Std. Dev.) and 0.9% SpMet (1 Std. Dev.) against a laboratory
CO-Oximeter.
