Warnings, Cautions, And Notes - Masimo RD SedLine Instrucciones De Uso

RD SedLine® EEG Sensor
Do not re-use
Prior to using this Sensor the user should read and understand the Operator's Manual for the Device or Monitor and
this Directions for Use.
INDICATIONS
PCX-2108A
02/13
The RD SedLine EEG Sensor electrodes are applied directly to the patient's skin to enable recording of electrophysiologic
signals )such as EEG(.
CONTRAINDICATIONS
The RD SedLine EEG Sensor is not intended for use in children less than 18 years of age.
DESCRIPTION
The RD SedLine EEG Sensor )1( is comprised of 6 gelled electrodes, 4 active channels )R1, R2, L1, L2(, one reference channel
)CT(, and one ground channel )CB(. The Sensor is a single-use, non-sterile product that does not contain natural rubber
latex.
Refer to the SedLine Operator's Manual for additional information including Warnings and Cautions.
WARNING: Masimo sensors and cables are designed for use with devices containing Masimo SET® oximetry or licensed to
use Masimo sensors.

WARNINGS, CAUTIONS, AND NOTES

• Warning: If skin irritation is noticed, discontinue use of the Sensor.
• Warning: To avoid cross contamination, only use Masimo single-use sensor on the same patient.
• Warning: Do not place electrodes between 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.
• Caution: Federal law restricts this device to sale by or on the order of a physician.
• Caution: For professional use. See instructions for use for full prescribing information, including indications,
contraindications, warnings, precautions and adverse events.
• Caution: Use the Sensor immediately after opening to prevent gel from drying out.
• Caution: Do not use the Sensor if pouch or product is defective.
• Caution: Do not allow electrode gel to come into contact with the SedLine Sensor connector as this may cause
impedance problems and inaccurate PSI readings.
• Caution: Each Sensor is approved for use up to 24 hours. If monitoring in excess of this period is desired, replace the
Sensor every 24 hours.
• Caution: SedLine is designed to operate with the sensor. Simultaneous use with other electrodes on the forehead is
not recommended.
• Caution: Do not use scissors to open pouch as this may cause damage to the Sensor.
• Caution: Do not cut the Sensor as this may result in improper operation.
• Caution: Applying excessive pressure to electrodes may lead to decreased signal quality, decreased PSI reliability, and
poor adhesion.
• Caution: The conductive parts of electrodes, sensors, or connectors should not contact other conductive parts
including earth ground.
• Do not attempt to reprocess, recondition or recycle any Masimo sensors or patient cables as these processes may
damage the electrical components, potentially leading to patient harm.
• Caution: Replace the sensor when a replace sensor message is displayed, or when a low SIQ message is consistently
displayed after completing the low SIQ troubleshooting steps identified in the monitoring device operator's manual.
• Note: The sensor is provided with X-Cal™ technology to minimize the risk of inaccurate readings and unanticipated
loss of patient monitoring. The sensor will provide up to 24 hours of patient monitoring. After single-patient use,
discard sensor.
D I R E C T I O N S FOR U S E
LATEX
Not made with natural rubber latex Non-sterile
3
en
Leave on for no more
24
than 24 hours
hr
9486E-eIFU-0617