Directions For Use; Contraindications - Masimo RD SET TC-I Mode D'emploi

RD SET™ 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 or Monitor and this

Directions for Use.

INDICATIONS
The RD SET™ TC-I reusable sensor is indicated for either "spotcheck" or continuous noninvasive monitoring of functional
oxygen saturation of arterial hemoglobin (SpO
patients, who are well or poorly perfused in hospitals, hospital- type facilities, mobile, and home environments.

CONTRAINDICATIONS

The RD SET TC-I reusable sensor is contraindicated for patients with pierced ears at the measuring site.
The RD SET 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.
DESCRIPTION
The RD SET TC-I reusable sensor is for use only with devices containing Masimo® SET® oximetry or licensed to use RD SET TC-I
sensors and compatible pulse oximeters. Consult individual device manufacturer for compatibility of particular device and sen-
sor models. Each device manufacturer is responsible for determining whether its device is compatible with each sensor model.
The RD TC-I sensors have been verified using Masimo SET Oximetry Technology.
WARNING: Masimo sensors and cables are designed for use with instruments containing Masimo SET® oximetry or licensed
to use Masimo sensors.
WARNINGS
• Do not use the RD SET TC-I on any site other than the ear lobe or pinna. This may result in inaccurate readings due to
tissue thickness.
• 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. Never use a damaged sensor or one with exposed electrical circuitry.
• The site must be checked frequently or per clinical protocol to ensure adequate adhesion, circulation, skin integrity and
correct optical alignment.
• Exercise extreme caution; skin erosion, tissue ischemia, and/or pressure necrosis can be caused when the sensor is not
frequently moved, applied too tightly, or becomes too tight due to edema. Assess site as frequently as every (1) hour and
move the sensor if there are signs of loss of skin integrity and/or loss of circulation or perfusion.
• 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.
• Carefully route sensor and patient cable to reduce the possibility of patient entanglement or strangulation.
• Misapplied sensors or sensors that become partially dislodged may cause incorrect measurements.
• Misapplications due to wrong sensor types can cause inaccurate or no readings.
• Inaccurate SpO readings may be caused by abnormal venous pulsation or venous congestion.
2
• 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. sensor on hand of a patient in a bed with arm
dangling to the floor, Trendelenburg position).
• Venous pulsations may cause erroneous low SpO
• 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.
• 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.
• 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 the unit might read zero for the duration of the active radiation period.
• Do not use the sensor during MRI scanning or in a MRI environment as it may result in physical harm.
• High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps,
fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of the sensor.
• To prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with
opaque material, if required. Failure to take this precaution in high ambient light conditions may result in inaccurate
measurements.
DIRECTIONS FOR USE
Not made with natural rubber latex
LATEX
PCX-2108A
02/13
) and pulse rate (measured by an SpO
2
2
readings (e.g. tricuspid valve regurgitation, Trendelenburg position).
3
sensor) for use with adult and pediatric
2
en
Non-Sterile
9004D-eIFU-0519