Environmental Specifications - Masimo RD SET TC-I Mode D'emploi

CLEANING
To surface clean the sensor
1. Remove the sensor from the patient and disconnect it from the patient cable.
2. Clean the RD SET TC-I sensor by wiping it with a 70% isopropyl alcohol pad or mild detergent.
3. Allow the sensor to dry prior to placement on a patient.
or
1. If low-level disinfection is required, wipe all surfaces of the RD SET TC-I sensor and cable with a cloth or gauze pad saturated
with a 1:10 bleach/water solution.
2. Saturate another cloth or gauze pad with sterile or distilled water and wipe all surfaces of the RD SET TC-I sensor and cable.
3. Dry the sensor and cable by wiping all surfaces with a clean cloth or dry gauze pad.
To clean or disinfect the sensor using a soaking method
1. Place the sensor in the cleaning solution (1:10 bleach/water solution), so that the sensor and desired length of cable are
completely immerse
WARNING: Do not immerse the connector end of the sensor cable as this may damage the sensor.
2. Dislodge air bubbles by gently shaking the sensor and cable.
3. Soak the sensor and the cable for at least 10 minutes and not greater than 24 hours. Do not immerse the connector.
4. Remove from cleaning solution.
5. Place the sensor and the cable in room temperature sterile or distilled water for 10 minutes. Do not immerse the connector.
6. Remove from the water.
7. Dry the sensor and cable with a clean cloth or dry gauze pad.
CAUTION:
• Do not use undiluted bleach (5%-5.25% sodium hypochlorite) or any cleaning solution other than those recommended
here because permanent damage to the sensor could occur.
• Do not immerse the connector on the RD SET TC-I cable in any liquid solution.
• Do not sterilize by irradiation, steam, autoclave, Gluteraldehyde (Cidex) or ethylene oxide.

ENVIRONMENTAL SPECIFICATIONS

Storage/Transport Temperature
Operating Temperature
Storage/Transport Humidity
Operating Humidity
SPECIFICATIONS
When used with Masimo SET pulse oximetry monitors, or with licensed Masimo SET pulse oximetry modules the RD SET TC-I
reusable sensor has the following specifications:
When used with compatible pulse oximeters the RD SET TC-I reusable sensor has the following specifications:
Sensor
Used with:
Body Weight
Application Site
SpO Accuracy, No Motion (70-100%
2
SpO Accuracy, Low Perfusion
2
Pulse Rate Accuracy, No Motion (25-240 bpm)
3
Pulse Rate Accuracy, Low Perfusion
NOTE: The A Accuracy is calculated based upon measurement values that are statistically distributed; approximately 68%
rms
of the measured values fell within ± the A
The Masimo SET Technology has been validated for no motion accuracy in human blood studies on healthy adult male
1
and female volunteers with light to dark pigmented skin in induced hypoxia studies in the range of 70-100% SpO
a laboratory 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%.
COMPATIBILITY
This sensor is intended for use only with devices containing Masimo SET oximetry or pulse oximetry monitors
licensed to use RD SET TC-I sensors and compatible pulse oximeters. Each sensor is designed to operate correctly
only on the pulse oximetry systems from the original device manufacturer. Use of this sensor with other devices
may result in no or improper performance.
For Compatibility Information Reference: www.Masimo.com
d.
1 )
2
value when compared to the reference device under a controlled study.
rms
-40°C to +70°C, ambient humidity
+5°C to +40°C, ambient humidity
10% to 95%, non-condensing
10% to 95%, non-condensing
RD SET TC-I
Masimo SET Technology
> 30 kg
Ear Lobe or Pinna
± 3.5%
± 3.5%
± 3 bpm
± 3 bpm
5
against
2
9004D-eIFU-0519