Directions For Use - Masimo RD SET Manual Del Usuario

RD SET™ Specialty Sensor Series
Adult, Pediatric, Infant, and Neonatal 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™ Specialty Sensor Series are indicated for the continuous noninvasive monitoring of functional oxygen
saturation of arterial hemoglobin (SpO
infant, 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
RD SET Speciality sensors are contraindicated for patients who exhibit allergic reactions to foam rubber products and/
or adhesive tape.
CAUTION: WITH SPECIALTY SENSORS, THE SENSOR OFF DETECTION PERFORMANCE MAY BE COMPROMISED.
DESCRIPTION
RD SET Specialty sensors enable the algorithms to give new data higher priority than old data regardless of the
averaging, sensitivity, or FastSat® setting. This results in a faster and more sensitive response to physiological changes.
The RD SET Specialty 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 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 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.
All manuals and user guides at all-guides.com

DIRECTIONS FOR USE

LATEX
PCX-2108A
02/13
) and pulse rate (measured by an SpO
2
Disposable Sensors
2
Not made with natural rubber latex
readings (e.g. tricuspid value regurgitation).
2
4
Non-sterile
sensor) for use with adult, pediatric,
2
en
9416B-eIFU-0916