Contraindications - Masimo LNCS TF-I Mode D'emploi

LNCS® TF-I®
Adult SpO Reusable Transflectance Sensor
2
Reusable
Prior to using this Sensor the user should read and understand the Operator's Manual for the Device or Monitor and
this Directions for Use.
INDICATIONS
The LNCS® TF-I® Reusable Transflectance sensor is indicated for the continuous non-invasive monitoring of arterial oxygen
saturation (SpO ) and pulse rate for adult and pediatric patients weighing > 30 kg.
2

CONTRAINDICATIONS

The LNCS TF-I is contraindicated for certain patient positions that affect the monitoring site – see the Warnings Section below.
The LNCS TF-I must be removed and repositioned to a different monitoring site at least every two (2) hours. If extended
monitoring is required, use of an LNCS single patient adhesive digit sensor is recommended.
DESCRIPTION
The LNCS TF-I sensor has been verified using Masimo SET technology.
The LNCS TF-I sensor is applied to the sensor site using a headband.
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 observed and the sensor repositioned at least every two (2) hours to ensure proper skin integrity and
proper alignment.
• Venous pulsations may cause erroneous low readings (e.g. tricuspid valve regurgitation). Mechanical ventilation can
cause increased intra-thoracic pressure and increase venous pooling in the head. This may cause erroneously low
readings.
• 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 hour with poorly perfused patients.
• During low perfusion, the sensor site needs to be assessed frequently for signs of tissue ischemia, which can lead
pressure necrosis.
• With very low perfusion at the monitored site, the readings may read lower than core arterial oxygen saturation.
• Sensors applied too tightly may cause erroneously low readings.
• Misapplied sensors or sensors that become partially dislodged may cause either over or under reading of actual arterial
oxygen saturation.
• If the sensor is damaged in any way, discontinue use immediately.
• Do not attempt to sterilize the sensor.
• Carefully route cable and patient cable to reduce the possibility of patient entanglement or strangulation.
• Intravascular dyes – may lead to inaccurate SpO
• Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO
• Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO
• Failure to apply the LNCS TF-I properly may cause incorrect measurements.
• Do not use the LNCS TF-I during MRI scanning.
• The pulsations from intra-aortic balloon support can be additive to the pulse rate on the oximeter pulse rate display.
Verify patient's pulse rate against the ECG heart rate or by manual palpation of the pulse rate.
• Venous congestion may cause under reading of actual arterial oxygen saturation. Therefore, assure proper venous
outflow from monitored site. Sensor should not be below heart level.
• Do not use this sensor under conditions where the patient is in the Trendelenburg's position (head lower than the heart).
• Do not modify or alter the sensor in any way. Alterations or modification may affect performance and/or accuracy.
• Caution: Replace the sensor when a replace sensor message is displayed, or when a low SIQ message is consistently
displayed after completing the low SIQ troubleshooting steps identified in the monitoring device operator's manual.
• Note: The sensor is provided with X-Cal™ technology to minimize the risk of inaccurate readings and unanticipated loss
of patient monitoring. The sensor will provide up to 8,760 hours of patient monitoring time. Replace the sensor when
the patient monitoring time is exhausted.
D I R E C T I O N S F O R U S E
LATEX
Not made with natural rubber latex
PCX-2108A
02/13
measurements.
2
3
measurements.
2
measurements.
2
en
+70 C
-40 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
NON Non-sterile
STERILE
5%-95% RH
LATEX
95%
%
5%
Title: Graphics, Sensor/Cable symbols, 03/06
GR-14231
DRO-13914
4165D-eIFU-1117