Masimo RD SET Blue Instrucciones De Uso página 4

RD SET™ Blue®
SpO Disposable Sensor
2
Single Patient Use Only
Prior to using this sensor, the user should read and understand the Operator's Manual for the Device and this
Directions for Use.
INDICATIONS
The Masimo® RD SET™ Blue® sensor is indicated for single-patient use for the continuous noninvasive monitoring of arterial
oxygen saturation (SpO
2
in hospitals, hospital type facilities, mobile and home environments.
CONTRAINDICATIONS
The RD SET Blue Sensor is contraindicated for patients who exhibit allergic reactions to foam rubber products and/or
adhesive tape.
DESCRIPTION
The RD SET Blue sensor is for use only with devices containing Masimo SET® oximetry or licensed to use RD SET sensors.
Consult individual oximetry system manufacturers for compatibility of particular device and sensor models. Each device
manufacturer is responsible for determining whether their device is compatible with each sensor model.
The RD SET Blue Sensor was validated on Masimo SET Oximetery Technology on neonates, infants and pediatric patients with
congenital cyanotic cardiac lesions.
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.
• Circulation distal to the sensor site should be checked routinely.
• 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. 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.
• 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.
• Avoid placing the sensor on any extremity with an arterial catheter or blood pressure cuff.
• 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.
D I R E C T I O N S F O R U S E
PCX-2108A
02/13
) and pulse rate for neonates, infants and pediatric patients with congenital cyanotic cardiac lesions
LATEX
Not made with natural rubber latex
readings (e.g. tricuspid valve regurgitation, Trendelenburg position).
2
4
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
9521B-eIFU-1218