Masimo RD SET E1 Instrucciones De Uso página 5

C) Attaching the Sensor to the Patient Cable
1. Refer to Fig. 4. 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. 5. 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.
Note: When changing application sites, or reattaching sensor, first attach the sensor to the application site, then connect the patient
cable to the sensor.
D) Stress and Exercise Testing
1. Attach the E1 Ear Sensor to the patient following the steps in B (Attaching the Sensor to the Patient).
To minimize unnecessary sensor motion during excessive patient movement, use a headband (not shown). Loop the ear sensor cable under
the chin, and secure the cable under the headband on the side of the head opposite the ear sensor.
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.
From the Patient:
1. Pull gently on the anchor pad and remove from the patient's shoulder.
2. To remove the E1 Ear Sensor from the patient's ear, gently pull apart the emitter and detector and remove.
CAUTION: To avoid discomfort to the patient or damage to the sensor, do not remove the sensor from the patient's ear by pulling on the
cable.
CAUTION: Avoid positioning the patient so that external pressure is applied to the sensor at the measuring site.
CAUTION: To prevent damage, do not soak or immerse the sensor in any liquid solution. Do not sterilize by irradiation, steam, autoclave or
ethylene oxide.
SPECIFICATIONS
When used with Masimo RD SET pulse oximetry monitors, Masimo RD rainbow SET pulse CO-Oximetry monitors, or with
licensed Masimo SET pulse oximetry or Masimo rainbow SET pulse CO-Oximetry modules, and patient cables, during no
motion, the RD E1 Ear sensor has the following specifications:
Sensor
Body Weight
Application Site
SpO Accuracy, No Motion
2
SpO Accuracy, Low Perfusion
2
Pulse Rate Accuracy, No Motion
Pulse Rate Accuracy, Low Perfusion
NOTE: The A
accuracy is a statistical calculation of the difference between device measurements and reference
RMS
measurements. Approximately two-thirds of the device measurements fell within +/- A
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 low perfusion accuracy in bench top testing against a Biotek Index 2 simulator
2
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 a
3
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%.
1
2
3
3
RD SET E1 Ear Sensor
> 30 kg
Ear
2.5%
2.5%
3 bpm
3 bpm
5
of the reference measurements
RMS
against a laboratory
2
9025B-eIFU-0119