Masimo O3 Instrucciones De Uso página 2

O3® Sensor
Adult and Pediatric rSO
Single Patient Use Only
INDICATIONS
The non-invasive Masimo O3® Regional Oximeter System and accessories are indicated for use as an adjunct monitor of regional hemoglobin
saturation of blood (rSO ) in the tissue under the sensors in patients in healthcare environments. The O3 Regional Oximeter is only to be used with
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Masimo O3 sensors. The use of any other sensor is not supported or recommended by Masimo and could give erroneous results.
When used with the O3 Adult Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen
saturation of blood (rSO ) in adults ≥ 40 kg.
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When used with the O3 Pediatric Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen
saturation of blood (rSO ) in pediatrics ≥ 5 kg and < 40 kg.
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CONTRAINDICATIONS
The O3 Sensors are contraindicated for patients who exhibit allergic reactions to adhesive tapes.
DESCRIPTION
The rSO sensor is a part of the Masimo O3 Regional Oximeter System. The sensor is intended for non-invasive rSO
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patient use.
WARNINGS, CAUTIONS, AND NOTES
• Periodically check skin integrity according to your institutions patient care protocol or at least every 24 hours.
• The O3 Sensor is intended only as an adjunct in patient assessment. It should not be used as the sole basis for diagnosis or therapy decisions.
It must be used in conjunction with clinical signs and symptoms.
• Always use the O3 Module and O3 Sensor in conjunction with Root. Do not use parts from other systems. Injury to personnel or equipment
damage could occur.
• The O3 Sensor should be free of visible defects, discoloration and damage. If the Sensor appears or is suspected to be discolored or damaged,
discontinue use. Never use a damaged sensor or one with exposed electrical circuitry.
• Do not modify or alter the O3 Sensor in any way. Alteration or modification may affect performance and/or electrical safety.
• Do not use sensors that are wet.
• Do not use the O3 Sensor during magnetic resonance imaging (MRI) or in an MRI environment.
• Do not use the O3 Module and O3 Sensor in the presence of flammable anesthetics or other flammable substance in combination with
air, oxygen-enriched environments, or nitrous oxide to avoid risk of explosion. Refer to the O3 Module Operator's Manual for additional
information.
• Do not place electrodes between the surgical site and the electro-surgical return electrode. Doing so increases the risk of burns in case of a
defect in the electro-surgical return electrode.
• As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.
• Avoid placing the sensor on any extremity with an arterial catheter or blood pressure cuff.
• 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.
• The site must be checked frequently or per clinical protocol to minimize the risk of skin irritation and to ensure adequate 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 one (1) hour with poorly perfused patients and move the sensor if there are signs of tissue ischemia.
• For patients experiencing complete bilateral External Carotid Artery (ECA) occlusion, rSO
WARNING: Optical measurements (rSO
• Improper sensor application or use of incorrect sensor.
• Intravascular dyes such as indocyanine green or methylene blue or externally applied coloring (such as indelible ink).
• Venous congestion and pooled blood under the skin.
• Moisture, birthmarks, skin discoloration or foreign objects (e.g. metal plate) in the light path.
• Elevated level of total bilirubin.
• A physiological condition that may affect vasomotor tone or changes in vasomotor tone.
• Excessive ambient light, high intensity light, or direct sunlight.
• Adjacent placement of optical sensors that are not connected to the same O3 Module.
• Abnormal venous pulsations (e.g. tricuspid value regurgitation, Trendelenburg position).
WARNING: Inaccurate rSO
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• Anemia or low hemoglobin concentrations
• Hemoglobinopathies (qualitative defects including sickle cell) and Hemoglobin synthesis disorders (Quantitative defects such as
Thalassemias).
• Elevated levels of COHb and/or MetHb levels.
• Non-normocapnic conditions or other conditions that affect blood volume.
• Hypotension, severe vasoconstriction, or hypothermia.
• Induction of extracranial hypoxia-ischemia.
• Cardiac arrest.
• Electrosurgical interference.
• Excessive induced motion.
CAUTIONS
• Do not use the O3 Sensor past its expiry date.
• Avoid contact with the sensor during defibrillation.
• Avoid sensor contact with liquids as it may cause damage to the sensor.
• Do not submerge the O3 Sensor in any cleaning solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any
other method. This will seriously damage the O3 Sensor.
Adhesive Sensor
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D I R E C T I O N S F O R U S E
PCX-2108A
02/13
) can be affected by the following:
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readings or no rSO reading may be caused by:
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LATEX
Not made with natural rubber latex
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measurements and for single
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measurements may be lower than expected.
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en
Non-sterile
9437E-eIFU-0221