Masimo LNCS TF-I Mode D'emploi page 5

CLEANING
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 may occur.
• To prevent damage, do not soak or immerse the connector in any liquid solution.
• Do not sterilize by irradiation, steam, autoclave, Gluteraldehyde (Cidex) or ethylene oxide.
To surface clean the sensor
1. Remove the sensor from the patient and disconnect it from the patient cable.
2. Remove Adhesive pad by pulling on white tab and discard. Any residue left by adhesive can easily be removed and
cleaned by wiping with 70% isopropyl alcohol.
3. Clean the LNCS TF-I sensor by wiping with a 70% isopropyl alcohol pad. If low-level disinfection is required, wipe with
a cloth or gauze pad saturated with a 1:10 bleach / water solution.
4. Saturate another cloth or gauze pad with sterile or distilled water and wipe all surfaces of the sensor and cable.
5. Dry the sensor and cable 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), such that the sensor pads and desired length
of cable are completely immersed.
WARNING: To prevent damage, do not soak or immerse the connector in any liquid solution.
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.
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 by wiping all surfaces with a clean cloth or dry gauze pad.
SPECIFICATIONS
When used with Masimo SET pulse oximetry monitors, or with licensed Masimo SET pulse oximetry modules and patient
cables, the LNCS TF-I sensors have the following specifications:
Sensor:
Body Weight
Application Site
1
SpO Accuracy, No Motion
2
Pulse Rate Accuracy, No Motion
NOTE: A accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-
rms
thirds of the device measurements fell within ± A
The Masimo SET Technology has been validated for no motion SpO
1
with light to dark pigmented skin in induced hypoxia studies in the range of 70–100% SpO
The Masimo SET Technology has been validated for pulse rate accuracy in bench top testing against a Biotek Index 2 simulator over a range of
2
25–240 bpm.
COMPATIBILITY
This sensor is intended for use only with devices containing Masimo SET oximetry or pulse oximetry monitors
licensed to use LNCS sensors. 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
WARRANTY
Masimo warrants to the initial buyer only that this product, when used in accordance with the directions provided with the
Products by Masimo, will be free of defects in materials and workmanship for a period of six (6) months. Single use products
are warranted for single patient use only.
THE FOREGOING IS THE SOLE AND EXCLUSIVE WARRANTY APPLICABLE TO THE PRODUCTS SOLD BY MASIMO TO BUYER.
MASIMO EXPRESSLY DISCLAIMS ALL OTHER ORAL, EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION
ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE. MASIMO'S SOLE OBLIGATION AND
BUYER'S EXCLUSIVE REMEDY FOR BREACH OF ANY WARRANTY SHALL BE, AT MASIMO'S OPTION, TO REPAIR OR REPLACE
THE PRODUCT.
2
of the reference measurements in a controlled study.
rms
LNCS TF-I
> 30 kg
Forehead
2 %
3 bpm
accuracy in human blood studies on healthy adult male and female volunteers
2
against a laboratory co-oximeter.
2
5
4165F-eIFU-0618