Covidien OxyAlert NIRSensor IS Guia De Inicio Rapido

For use with INVOS® 5100C System ONLY. OxyAlert NIRSensor disposable sensor Model IS has a small adhesive pad and a gentle hydrocolloid adhesive
for use with pediatric, infant and neonatal patients. Suitable for patients weighing < 40 kilograms. For additional information regarding setup and use of the
INVOS System, consult the Operations Manual.
INDICATIONS FOR USE: The noninvasive INVOS System is intended for use as an adjunct
monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue
beneath the sensor. It is intended for use in individuals greater than 2.5 kg at risk for
reduced-flow or no-flow ischemic states. It is also intended for use as an adjunct trend
monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue
beneath the sensor in any individual.
CONTRAINDICATIONS: None
WARNINGS:
• The sensor is designed for single patient use only and may not be used on multiple
patients due to an increased risk of cross-contamination among patients. Do not
autoclave or gas sterilize the sensors.
• The sensor is designed for external use only as described in the instructions. Do not
use the sensors internally for any reason.
• Do not immerse the INVOS System or sensor in any liquids as they may cause electric
shock hazard or damage the device.
• Do not use the INVOS System in the presence of flammable anesthetics or in other
flammable environments.
• The prospective clinical value of data from the INVOS System has not been
demonstrated in disease states. The INVOS System should not be used as the sole
basis for diagnosis or therapy.
PRECAUTIONS:
• INVOS readings represent a small volume of tissue beneath the sensor and may not
reflect oxygenation disturbances that occur elsewhere.
• Make sure all connectors are fully engaged and free from moisture. Moisture intrusion
may cause inaccurate readings, erratic readings or no readings at all.
• Different INVOS System sensors (adult, pediatric and infant/neonatal) cannot be used
simultaneously on the same monitor.
• Use only Covidien recommended or provided accessories. Use of the INVOS System
with any other sensor will compromise accuracy.
• Use care when placing or removing sensor. Do not place on broken or undeveloped
skin.
• If present, the following may cause inaccurate readings:
o "Cardiogreen," "Indigo Carmine," "Methylene Blue" or other intravascular dyes
o Carboxyhemoglobin or other dyshemoglobins
o Hemoglobinopathies
o Conjugated hyperbilirubinemia (direct)
o Myoglobin (Mb) in muscle tissues
• Do not place the sensor on regions with severe tissue edema to reduce the possibility
of skin lesions.
• Use of an electrosurgical/electrocautery instrument in the vicinity of the INVOS
System may interfere with the signal and result in no readings.
• Environments with excessive ambient light such as bright sunlight or strong
operating room lighting may require loosely covering the area of the sensor with an
opaque drape.
• To avoid pressure sores do not apply pressure (e.g. headbands, wraps, tape) to sensor.
• Sensors do not need to be removed for X-ray or CT Scan. However, sensors will appear
on image. Sensors must be removed for MRI.
INSTRUCTIONS FOR USE
Pre-use Check: Remove the sensor from the package and examine for visual signs of
damage. If any signs of damage are observed, select another sensor.
Cerebral Site Selection: Select sensor site on the right or left side of forehead. Placement
of the sensor in other cerebral locations, or over hair, may cause inaccurate readings, erratic
readings, or no readings at all. Do not place the sensor over nevi, sinus cavities, the superior
sagittal sinus, subdural or epidural hematomas or other anomalies such as arteriovenous
malformations, as this may cause readings that are not reflective of brain tissue or no
readings at all.
Somatic Site Selection: Select sensor site over tissue area of interest (site selection will
determine which body region is monitored). Avoid placing the sensor over fatty deposits,
hair or bony protuberances. Do not place the sensor over nevi, hematomas or broken skin,
as this may cause readings that are not reflective of tissue or no readings at all. Sensor
© 2011 Covidien. Somanetics, INVOS, SomaSensor, "OxyAlert, " "OxyAlert NIRSensor, " "Reflecting the color of life, " "Window to the Brain, " "Enlightening Medicine, " Vital Sync, "iCuro, " "Area Under the Curve, " "AUC, " "SCR" and "Somanetics Alliance" are trademarks of a Covidien company. Trademarks,
all product packaging and logos are protected by trademark rights, copyrights and other rights owned by a Covidien company. Other trademarks belong to their respective owners.
OxyAlert™ NIRSensor
Infant/Neonatal Sensor • Model IS
location is at the clinician's discretion, provided it adheres to the criteria noted on this
Instruction For Use. Placements may include:
o Posterior flank (T10-L2, right or left of midline)
o Abdomen
o Forearm
o Calf
o Upper arm
o Chest
o Upper leg
Patient Prep: To achieve optimum adhesion, the patient's skin must be clean and dry. Dry
skin with a gauze pad. Warm the sensor in your hands or an incubator to ease placement.
Sensor Placement: Holding the cable, peel back the two halves of the white liner from
the clear adhesive layer beginning at the center of the sensor pad. Apply to the skin.
Continue applying the sensor by smoothing it to the skin from the center outward. Ensure
edges of the sensor are sealed.
Figure 1
Sensor Placement
Monitoring: Plug the sensor cable into the preamplifier connector. When two somatic site
sensors are placed, they must be connected into the same preamplifier. Secure the sensor
cable to a fixed object to avoid strain on the sensor-to-skin interface using strain-relief
clips. Ensure the cable is properly inserted into the preamplifier. Calibration is automatic
and monitoring will begin in seconds.
Status messages on the INVOS System display will appear if monitoring conditions are
compromised. Periodically check skin integrity according to your institution's patient care
protocol or at least every 24 hours. If sensors are removed or peeled back to do so, be sure
sensor is properly re-sealed to skin to avoid light entering.
For extended monitoring, if the adhesive is inadequate to seal the sensor to the
skin, apply a new sensor.
Covidien llc
15 Hampshire Street, Mansfield, MA 02048 USA
Ph: 800.635.5267
www.covidien.com
PN 314000 Rev. D