Masimo RD SedLine EEG Mode D'emploi page 3

RD SedLine® EEG
Adult Sensor
Do not re-use
Prior to using this Sensor the user should read and understand the Operator's Manual for the Device,
Monitor and this Directions for Use.
INDICATIONS
PCX-2108A
02/13
The RD SedLine EEG Adult Sensor electrodes are applied directly to the patient's skin to enable recording of electrophysiologic
signals (such as EEG).
CONTRAINDICATIONS
The RD SedLine EEG Adult 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.
• Caution: 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, or equivalent message is displayed consistently. Consult monitoring
device operator's manual for more information.
• 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 time. After single-use, discard sensor.
INSTRUCTIONS
A) Connecting the Sensor
1. Prepare the forehead skin with alcohol and dry before applying the sensor.
2. Refer to Fig. 1. Peel the center of the sensor from the tray and discard.
3. Refer to Fig. 2. Apply central electrodes onto the forehead and center CT/CB electrodes above the nose.
4. Refer to Fig. 3. Press the central electrodes down firmly on to the forehead.
5. Refer to Fig. 4. Peel the outer electrodes R2/L2 from the individual trays and apply R2/L2 on to the hairless area
just above the temple.
6. Align the yellow indicator on the end of the patient cable to the yellow indicator on the sensor connector.
D IREC TIO N S FO R US E
LATEX
Not made with natural rubber latex Non-sterile
3
en
Leave on for no more
24
hr
than 24 hours
9850D-eIFU-0219