Masimo RD rainbow SET-2 SpO2 Mode D'emploi page 5

RD rainbow SET™-2
SpO , SpMet®, and SpHb® Disposable Sensors
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
RD rainbow SET™-2 disposable sensors are indicated for the continuous noninvasive monitoring of functional oxygen
saturation of arterial hemoglobin (SpO2), pulse rate, methemoglobin saturation (SpMet®), and/or total hemoglobin (SpHb®).
The rainbow Series disposable sensors are indicated for use with adult, pediatric, 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 rainbow SET disposable sensors are contraindicated for patients who exhibit allergic reactions to adhesive tape.
DESCRIPTION
RD rainbow SET-2 disposable sensors have been verified using Masimo rainbow SET™ technology. RD rainbow SET disposable
sensors are for use with devices containing Masimo rainbow SET technology (Version 7.4 or higher) or licensed to use
rainbow® compatible sensors. Consult individual oximetry system manufacturers for compatibility of particular devices and
sensor models. Each device manufacturer is responsible for determining whether their devices are compatible with each
sensor model.
WARNING: Masimo sensors and cables are designed for use with devices containing Masimo rainbow SET oximetry or
licensed to use Masimo sensors.
NOTE: Though this sensor is capable of reading all parameters, it is limited by the parameters on the device.
WARNINGS
• Laboratory diagnostic tests using blood samples should be conducted prior to clinical decision making to completely
understand the patient's condition.
• Comparisons between SpHb measurements and laboratory diagnostic hemoglobin measurements may be affected by
sample type, collection technique, physiological, and other factors.
• 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.
• Do not use the sensor during MRI scanning or in a MRI environment as it may result in physical harm.
• 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.
• Sensors applied too tightly or that become tight due to edema will cause inaccurate readings and can cause pressure
necrosis.
• 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.
• 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.
• High oxygen concentrations may predispose a premature infant to retinopathy. Therefore, the upper alarm limit for the
oxygen saturation must be carefully selected in accordance with accepted clinical standards.
• Misapplied sensors or sensors that become partially dislodged may cause incorrect readings.
• Misapplications due to wrong sensor types can cause inaccurate or no readings.
• Inaccurate readings may be caused when values are provided with a low signal confidence indicator.
• Intravascular dyes such as indocyanine green or methylene blue or externally applied coloring and texture such as nail
polish, acrylic nails, glitter, etc. may lead to inaccurate or no readings.
D IREC TIO N S FO R US E
Not made with natural rubber latex
LATEX
PCX-2108A
02/13
5
en
Non-sterile
9357F-eIFU-1117