Masimo RD SET TFA-1 Manual De Instrucciones página 3

RD SET™ TFA-1®
SpO Disposable Transflectance Forehead Sensor
2
Single Patient Use Only
INDICATIONS
The Masimo Disposable Transflectance Forehead Sensors are indicated for continuous noninvasive monitoring of functional
oxygen saturation of arterial hemoglobin (SpO
intended for use with adult and pediatric patients, weighing greater than 10 kg, who are well or poorly perfused in healthcare
environments.
CONTRAINDICATIONS
The RD SET TFA-1 is contraindicated for certain patient positions that affect the monitoring site - see the Warnings Section
below.
DESCRIPTION
The RD SET TFA-1 sensors are intended for use only with devices containing SET® technology, Masimo® SET® MS-2000
(Version 4.8.1.1 or higher) technology or Masimo rainbow SET™ MX (Version 7.1 or higher) technology.
The RD SET TFA-1 sensors have been validated on the Masimo rainbow® SET MX technology which includes the Masimo SET
Oximetry technology. The Masimo rainbow SET MX technology is included in the Radical-7®, Rad-87®, and Rad-57® devices.
The RD SET TFA-1 sensors are applied to the sensor site using a headband. The sensor may be applied up to twelve (12)
hours with periodic checking for circulatory condition changes and skin integrity. Remove and assess skin conditions every
2 hours, if needed.
WARNING: Masimo sensors and cables are designed for use with devices containing Masimo SET oximetry or licensed to
use Masimo sensors.
WARNINGS
• 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 site must be checked frequently or per clinical protocol to ensure adequate adhesion, circulation, skin integrity and
correct optical 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 as frequently as 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.
• With very low perfusion at the monitored site, the reading may read lower than core arterial oxygen saturation.
• 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.
• Sensors applied too tightly or that become tight due to edema will cause inaccurate readings and can cause pressure
necrosis.
• Misapplied sensors or sensors that become partially dislodged may cause incorrect measurements.
• 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).
• 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.
• 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.
• Carefully route cable and patient cable to reduce the possibility of patient entanglement or strangulation.
• 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.
• 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.
• High levels of COHb or MetHb may occur with a seemingly normal SpO
suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed.
• Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO
D I R E C T I O N S F O R U S E
LATEX
Not made with natural rubber latex
) and pulse rate. The Masimo Disposable Transflectance Forehead Sensors are
2
PCX-2108A
02/13
readings (e.g. tricuspid valve regurgitation, Trendelenburg position).
2
3
. When elevated levels of COHb or MetHb are
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
9508D-eIFU-0319