Masimo RD rainbow 4 Instrucciones De Uso página 4

RD rainbow 4λ
SpO 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™ 4λ disposable sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation
of arterial hemoglobin (SpO
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 4λ disposable sensors are contraindicated for patients who exhibit allergic reactions to adhesive tape.
DESCRIPTION
RD rainbow 4λ series sensors are for use with devices containing SET® oximetry or licensed to use RD rainbow 4λ 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 or 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.
• 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.
• 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 measurements.
• 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.
• Inaccurate readings may be caused by birthmark(s), tattoos, or skin discolorations in sensor path, moisture on the skin, deformed
fingers, misaligned sensor emitter and detector, EMC interference from other sensors attached to the patient, and objects
blocking the light path.
• Avoid placing the sensor on any extremity with an arterial catheter or blood pressure cuff.
• Carefully route cable and patient cable to reduce the possibility of patient entanglement or strangulation.
• 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).
• Inaccurate SpO readings may be caused by abnormal venous pulsation or venous congestion.
2
• 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.
• 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.
• High intensity extreme lights (such as pulsating strobe lights) directed on the sensor, may not allow the Pulse CO-Oximeter to
obtain vital sign readings.
• 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.
• 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.
All manuals and user guides at all-guides.com
D I R E C T I O N S F O R U S E
Not made with natural rubber latex
LATEX
PCX-2108A
02/13
) and pulse rate for use with adult, pediatric, infant, and neonatal patients during both no
2
4
en
Non-sterile
10571B-eIFU-0620