Masimo Rad-G YI Manual De Instrucciones página 4

Rad-G
®
SpO Multisite Reusable Sensor and Single Patient Use Attachment Wraps
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Reusable (sensor)
Prior to using this sensor, the user should read and understand the Operator's Manual for the Device and this Directions
for Use.
INDICATIONS
The Rad-G YI Reusable Sensor is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial
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hemoglobin (SpO ) and pulse rate (measured by an SpO
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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 Rad-G YI Multisite Reusable Sensor is contraindicated for patients who exhibit allergic reactions to foam urethane products and/
or adhesive tape.
DESCRIPTION
The Rad-G YI sensor is applied to the sensor site using Masimo
only. The Rad-G YI is for use only with devices containing Masimo SET
Attachment Wraps are for use only with the Rad-G YI Reusable Multisite Sensors. Consult individual instrument manufacturer for
compatibility of particular instrument and sensor models. Each instrument manufacturer is responsible for determining whether
its instruments are compatible with each sensor model. The YI series has been verified using Masimo SET Oximetry Technology.
The sensor must be removed and the site inspected at least every four (4) hours or sooner, and, if indicated by circulatory condition
or skin integrity, reapplied to a different monitoring site.
WARNING: Masimo sensors and cables are designed for use with devices containing Masimo SET
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 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 (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.
• Carefully route cable and patient cable to reduce the possibility of patient entanglement or strangulation.
• Misapplied sensors or sensors that become partially dislodged may cause incorrect measurements.
• Misapplications due to wrong sensor types can cause inaccurate or no readings.
• Sensors applied too tightly or that become tight due to edema will cause inaccurate readings and can cause pressure necrosis.
• Inaccurate SpO readings may be caused by abnormal venous pulsation or venous congestion.
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• 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).
• Venous pulsations may cause erroneous low SpO
• The pulsations from intra-aortic balloon support can be additive to the pulse rate on the oximeter pulse rate display.
Verify patient's pulse rate against the ECG heart rate.
• 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 the unit might read zero 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.
• 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.
• Inaccurate readings may be caused by EMI radiation interference.
• Abnormal fingers, 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 SpO
• High levels of COHb or MetHb may occur with a seemingly normal SpO
suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed.
• Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO
• Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO
• Elevated Total Bilirubin levels may lead to inaccurate SpO
• Inaccurate SpO readings may be caused by severe anemia, low arterial perfusion or motion artifact.
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• Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle cell, etc. may cause inaccurate SpO
readings.
• Inaccurate SpO readings may be caused by vasospastic disease such as Raynaud's, and peripheral vascular disease.
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YI
D I R E C T I O N S F O R U S E
LATEX
PCX-2108A
02/13
Not made with natural rubber latex
sensor) for use with adult, pediatric, infant, and neonatal patients during
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attachment wraps. The attachment wraps are for single-patient use
®
oximetry or licensed to use Rad-G YI sensors. The Masimo
®
readings (e.g. tricuspid valve regurgitation, Trendelenburg position).
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measurements.
2
measurements.
2
measurements.
2
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oximetry or licensed to use
®
. When elevated levels of COHb or MetHb are
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measurements.
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en
Non-sterile
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9987E-eIFU-1221