Masimo RD SET Manual Del Usuario página 6

NEONATES (< 3 kg)
1. Refer to Fig. 3a. For fragile skin, the stickiness of the medical grade adhesive can be diminished or eliminated by
daubing the adhesive areas with a cotton ball or gauze.
2. Refer to Fig. 3b. Direct the sensor cable toward the ankle (or wrist). Apply the sensor around the lateral aspect of the
foot (or hand), aligned with the fourth toe (or finger). Complete coverage of the detector window is needed to ensure
accurate data.
3. Refer to Fig. 3c. Wrap the foam wrap around the lateral aspect of the foot (or hand) and ensure that the emitter
window ( ) aligns directly opposite of the detector. Be careful to maintain proper alignment of the detector and
emitter windows while attaching foam wrap to secure the sensor.
4. Refer to Fig. 3d. Check the sensor to verify correct positioning and reposition if necessary.
C) Attaching the Sensor to the Patient Cable
1. Refer to Fig. 4a. Orient the sensor's connector tab so that the side with the "shiny" contacts is facing up. Orient the
patient cable with the color bar and finger grips facing up.
2. Refer to Fig. 4b. Insert the sensor tab into the patient cable until there is a tactile or audible click of connection. Gently
tug on the connectors to ensure a positive contact. Tape may be used to secure the cable to the patient for ease of
movement.
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.
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. 5. 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 SET pulse oximetry monitors, or with licensed Masimo SET pulse oximetry modules the RD SET
Specialty Sensors have the following specifications:
RD SET Specialty Sensor
Body Weight
Application Site
SpO Accuracy, No Motion
2
SpO Accuracy, Motion
2
2
SpO Accuracy, Low Perfusion
2
Pulse Rate Accuracy, No Motion
Pulse Rate Accuracy, Motion
Pulse Rate Accuracy, Low Perfusion
NOTE: The Arms Accuracy is calculated based upon measurement values that are statistically distributed; approximately 68% of
the measured values fell within +/- the Arms value when compared to the reference device in a controlled study.
The Masimo SET Technology has been validated for no motion accuracy in human blood studies on healthy adult male and female
1
volunteers with light to dark pigmented skin in induced hypoxia studies in the range of 70%-100% SpO
co-oximeter.
The Masimo SET Technology has been validated for motion accuracy in human blood studies on healthy adult male and female
2
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
The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator
3
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%.
The Masimo SET Technology has been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against
4
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%.
The saturation accuracy of the Neonate sensors were validated on adult volunteers and 1% was added to account for the properties
5
of fetal hemoglobin.
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Trauma (Adult)
> 30 kg
Finger or Toe
2%
1
3%
2%
3
3 bpm
4
5 bpm
4
3 bpm
3
against a laboratory co-oximeter.
2
Pediatric Infant
10 - 30 kg 3 - 10 kg
Thumb or Great
Finger or Toe
Toe
2% 2%
3% 3%
2% 2%
3 bpm 3 bpm
5 bpm 5 bpm
3 bpm 3 bpm
6
Neonate
< 3 kg
Hand or Foot
3%
5
3%
3%
3 bpm
5 bpm
3 bpm
against a laboratory
2
9416B-eIFU-0916