Contraindications; Warnings, Cautions, And Notes - Masimo RD SET TF-I Mode D'emploi

RD SET™ TF-I®
SpO Reusable Transflectance Forehead Sensor
2
Reusable
Prior to using this sensor, the user should read and understand the Operator's Manual for the monitor
and this Directions for Use.
INDICATIONS
The RD SET™ TF-I® Reusable Transflectance forehead sensor is indicated for the continuous noninvasive monitoring of arterial
oxygen saturation (SpO
2

CONTRAINDICATIONS

The RD SET TF-I is contraindicated for certain patient positions that affect the monitoring site - see the Warnings Section
below. The RD SET 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 RD SET single patient adhesive digit sensor is recommended.
DESCRIPTION
The RD SET TF-I sensor is applied to the sensor site using a headband.
The RD SET TF-I is for use only with devices containing Masimo SET® oximetry or licensed to use TF-I sensors. Consult individual
oximetry system manufacturers for compatibility of particular devices and sensor models. Each device manufacturer is
responsible for determining whether their devices are compatible with each sensor model.
The RD-SET TF-I series has been verified using Masimo SET® Oximetry Technology.
WARNING: Masimo® sensors and cables are designed for use with devices containing Masimo SET® oximetry or licensed to
use Masimo sensors.

WARNINGS, CAUTIONS, AND NOTES

• All sensors and cables are designed for use with specific monitors. Verify the compatibility of the monitor, cable and
sensor before use, otherwise degraded performance and/or patient injury can result.
• The sensor should be free of visible defects, discoloration and damage. If the sensor is discolored or damaged,
discontinue use immediately. Never use a damaged sensor or one with exposed electrical circuitry.
• The site must be observed and the sensor repositioned at least every two (2) hours to ensure proper skin integrity and
proper alignment.
• 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 (1) hour with poorly perfused patients and move the sensor if
there are signs of tissue ischemia.
• During low perfusion, the sensor site needs to be assessed frequently for signs of tissue ischemia, which can lead to
pressure necrosis.
• SpO readings may be affected under very low perfusion conditions at the monitored site.
2
• 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 incorrect measurements.
• Sensors applied too tightly may cause erroneously low readings. Applying the headband too tightly can lead to
inaccurate saturation measurements, or possibly lead to temporary pressure marks from the sensor.
• Carefully route cable and patient cable to reduce the possibility of patient entanglement or strangulation.
• Do not use this sensor under conditions where the patient is in the Trendelenburg position (head lower than the heart).
• Do not use the sensor during MRI scanning or in a MRI environment.
• Inaccurate readings may be caused by EMI radiation interference.
• If using pulse oximetry during full body irradiation, keep the sensor out of the radiation field. If sensor is exposed to the
radiation, the reading might be inaccurate or not provided for the duration of the active radiation.
• Venous pulsations may cause inaccurate readings (e.g. tricuspid valve regurgitation, Trendelenburg position).
Mechanical ventilation can cause increased intra-thoracic pressure and increase venous pooling in the head. This may
cause inaccurate readings.
• 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.
• 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 (e.g. Trendelenburg position).
D I R E C T I O N S F O R U S E
Not made with natural rubber latex
LATEX
PCX-2108A
02/13
) and pulse rate for adult and pediatric patients weighing > 30 kg.
3
en
+70 C
-40 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
Non-sterile
NON
STERILE
5%-95% RH
LATEX
95%
%
5%
Title: Graphics, Sensor/Cable symbols, 03/06
GR-14231
DRO-13914
9023D-eIFU-0618