Directions For Use - Masimo M-LNCS TC-I Mode D'emploi

M-LNCS™/LNCS®/LNOP® TC-I
Reusable Tip Clip Sensor
Reusable
Prior to using this sensor, the user should read and understand the Operator's Manual for the device and this Directions for Use.
INDICATIONS
PCX-2108A
02/13
When used with Masimo SET:
The M-LNCS™/LNCS®/LNOP® TC-I, Reusable Sensor is indicated for either "spotcheck" or continuous non-invasive monitoring
of functional oxygen saturation of arterial hemoglobin (SpO
and pediatric patients, (weighing > 30 kg), who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and
home environments.
When used with NELLCOR AND NELLCOR COMPATIBLE PULSE OXIMETERS:
The M-LNCS™/LNCS®/LNOP® TC-I reusable sensor is indicated for either "spot check" or continuous noninvasive monitoring of
functional oxygen saturation of arterial hemoglobin (SpO
and pediatric patients, (weighing > 30 kg), in hospitals, hospital-type facilities, mobile, and home environments.
CONTRAINDICATIONS
The TC-I reusable sensor is contraindicated for patients with pierced ears at the measuring site.
DESCRIPTION
The TC-I is for use only with devices containing Masimo SET® oximetry or licensed to use Masimo sensors and also with
Nellcor and Nellcor compatible pulse oximeters. Consult individual device manufacturer for compatibility of particular
device and sensor models. Each device manufacturer is responsible for determining whether its devices are compatible with
each sensor model.
The TC-I sensor has been verified using Masimo SET Oximetry Technology and on Nellcor's N-200 Pulse Oximeter.
If extended monitoring is required, use of a Masimo disposable sensor is recommended.
The TC-I reusable sensor must be removed and repositioned to a different monitoring site at least every four (4) hours.
Because individual skin conditions and perfusion levels affect the ability of the site to tolerate sensor placement, it may be
necessary to move the sensor more frequently.
WARNING: Masimo sensors and cables are designed for use with devices containing Masimo SET® oximetry or licensed to
use Masimo sensors.
WARNINGS
• The site must be changed at least every four (4) hours.
• Circulation distal to the sensor site should be checked routinely.
• Do not use the TC-I on any site other than the ear lobe or pinna. This may result in inaccurate readings due to tissue
thickness.
• Exercise extreme caution with poorly perfused patients; skin erosion and pressure necrosis can be caused when the
sensor is not frequently moved. Assess site at least every two (2) hours with poorly perfused patients.
• During low perfusion, the sensor site needs to be assessed frequently for signs of tissue ischemia, which can lead to
pressure necrosis.
• Do not use tape to secure the sensor to the site; this can restrict blood flow and cause inaccurate readings. Use of
additional tape can cause skin damage and/or pressure necrosis or damage the sensor.
• Misapplied sensors or sensors that become partially dislodged may cause either over or under reading of actual arterial
oxygen saturation.
• With very low perfusion at the monitored site, the reading may read lower than core arterial oxygen saturation.
• Failure to apply the sensor properly may cause incorrect measurements.
• Elevated levels of Carboxyhemoglobin (COHb) will lead to inaccurate SpO
• Elevated levels of Methehemoglobin (MetHb) will lead to inaccurate SpO
• Elevated levels of Total Bilirubin may lead to inaccurate SpO
• Intravascular dyes or externally applied coloring may lead to inaccurate SpO
• Sensors applied too tightly may cause erroneously low readings.

DIRECTIONS FOR USE

Not made with natural rubber latex
LATEX
) and pulse rate (measured by an SpO
2
) and pulse rate (measured by an SpO
2
measurements.
2
measurements.
2
measurements.
2
2
4
795 mmHg - 375 mmHg
Non-Sterile
NON
STERILE
LATEX
95%
%
5%
sensor) for use with adult
2
sensor) for use with adult
2
measurements.
en
+70 C
-40 C
+1060 hPa - +500 hPa
5%-95% RH
5357F-eIFU-0817