Masimo RD SET Serie Manual página 5

RD SET® Series
Adt, Pdt, Inf, Neo, NeoPt, and NeoPt-500 SpO
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 - When Used With Masimo SET® and Masimo® compatible Pulse Oximeters:
The RD SET® Series disposable sensors are indicated for the continuous noninvasive monitoring of functional oxygen
saturation of arterial hemoglobin (SpO
and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in
hospitals, hospital-type facilities, mobile, and home environments.
CONTRAINDICATIONS
The RD SET sensors are contraindicated for patients who exhibit allergic reactions to foam rubber products and/or adhesive
tape.
DESCRIPTION
The RD SET Series sensors are for use with devices containing Masimo SET oximetry or licensed to use RD SET Series sensors.
Consult individual device manufacturer for compatibility of particular device and sensor models. Each device manufacturer is
responsible for determining whether its devices are compatible with each sensor model.
WARNING: Masimo sensors and cables are designed for use with devices containing 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. 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 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.
• Misapplications due to wrong sensor types can cause inaccurate or no readings.
• 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).
• Venous pulsations may cause erroneous low SpO
• The pulsations from intra-aortic balloon support can affect the pulse rate displayed on the oximeter. Verify patient's pulse
rate against the ECG heart rate.
• 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 not provided 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.
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
) and pulse rate (measured by an SpO
2
readings (e.g. tricuspid value regurgitation).
2
5
Disposable Sensors
2
sensor) for use with adult, pediatric, infant,
2
en
Non-sterile
10497A-eIFU-1220