Masimo SedLine Sensor Instrucciones De Uso página 3

SedLine® Sensor
Single Patient Use Only
DESCRIPTION
The SedLine 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.
PCX-2108A
02/13
INDICATIONS
The Sensor electrodes are applied directly to the patient's skin to enable recording of electrophysiologic signals (such as EEG).
CONTRAINDICATIONS
This device is not intended for use in children less than 18 years of age.
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.
INSTRUCTIONS
Connecting the Sensor
To connect the Sensor
1. Prep skin with alcohol and dry before applying Sensor.
2. Peel the release liner from the center foam and discard.
3. Center CB/CT electrodes on forehead above nose (2). Press the white lining around the electrodes firmly onto the forehead with
palm of hand to secure the Sensor (3). Do not press directly on the electrode, otherwise the gel may leak out.
4. Apply R2/L2 in hairless area just above temple (4).
5. Apply R1/L1 to either side of CB.
6. Align the white end of the Patient Cable with the arrow on the Sensor connector (5).
7. Push together until the Sensor stiffener latch clicks into place.
8. Ensure the monitor is connected and powered up.
9. If any of the electrodes are displayed as red, yellow, or blue, push and wiggle the white lining around the electrodes. Do not
press directly on the electrode, otherwise the gel may leak out.
10. For additional details, see the SedLine Operator's Manual.
Disconnecting the Sensor
To disconnect the Sensor, gently pull the Sensor connector out of the Patient Cable connector.
Sensor Removal
To remove the sensor from the patient's forehead, pull each electrode tab gently away from the skin.
If the sensor is difficult to remove, use alcohol to assist in removal.
Note: The Sensor is not reusable. Dispose of the sensor according to local laws.
WARRANTY
Masimo warrants to the initial buyer only that this product, when used in accordance with the directions provided with the Products
by Masimo, will be free of defects in materials and workmanship for a period of six (6) months. Single use products are warranted for
single patient use only.
D IREC TIO N S FO R US E
LATEX
Not made with natural rubber latex Non-sterile
3
Leave on for no more than 24 hours
8473D-eIFU-0420
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