MASIMO RD SedLine EEG Adult Sensor User Guide

: June 7, 2024
: MASiMO

Table of Contents

DIRECTIONS FOR USE
INDICATIONS
CONTRAINDICATIONS
DESCRIPTION
WARNINGS, CAUTIONS AND NOTES
INSTRUCTIONS
WARRANTY
Documents / Resources

MASIMO RD SedLine EEG Adult Sensor

DIRECTIONS FOR USE

Do not re-use
Not made with natural rubber latex
Non-sterile
Leave on for no more than 24 hours

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

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

Prepare the forehead skin with alcohol and dry before applying the sensor.
Refer to Fig. 1. Remove the sensor from the pouch and detach the end of the white tray holding the peripheral leads (R2 and L2), so that they are now independent of the center tray.
Refer to Fig. 2. Peel the center of the sensor from the tray and discard.
Refer to Fig. 3. Apply central electrodes onto the forehead and center CT/CB electrodes above the nose.
Refer to Fig. 4. Press the central electrodes down firmly on to the forehead.
Refer to Fig. 5. Peel the outer electrodes R2/L2 from the individual trays and apply R2/L2 on to the hairless area just above the temple.
Align the yellow indicator on the end of the patient cable to the yellow indicator on the sensor connector.
Refer to Fig. 6. Push together until the sensor connector fits into the patient cable.
Ensure the SedLine Module is connected to the SedLine patient cable and the Root monitor.
If any of the electrodes are displayed as red, yellow, or blue, press firmly on the electrodes.
For additional details, see the SedLine Operators Manual.

B) Disconnecting the Sensor
To disconnect the Sensor, gently pull the Sensor connector out of the Patient Cable connector.

C) 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.
D) Applying with the O3® Adult Sensor when using O3 Regional Oximetry
Refer to Fig. 7. Following the application of the RD SedLine EEG Sensor, align the rounded section of each O3 sensor with the curves of the O3 sensor marked on the t-section of the RD SedLine EEG Sensor and refer to Fig. 8. position above L1/R1 and L2/R2.

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.
THE FOREGOING IS THE SOLE AND EXCLUSIVE WARRANTY APPLICABLE TO THE PRODUCTS SOLD BY MASIMO TO BUYER. MASIMO EXPRESSLY DISCLAIMS ALL OTHER ORAL, EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE. MASIMO’S SOLE OBLIGATION AND BUYER’S EXCLUSIVE REMEDY FOR BREACH OF ANY WARRANTY SHALL BE, AT MASIMO’S OPTION, TO REPAIR OR REPLACE THE PRODUCT.

WARRANTY EXCLUSIONS
This warranty does not extend to any product that has been used in violation of the operating instructions supplied with the product, or has been subject to misuse, neglect, accident or externally created damage. This warranty does not extend to any product that has been connected to any unintended instrument or system, has been modified, or has been disassembled or reassembled. This warranty does not extend to sensors or patient cables that have been reprocessed, reconditioned or recycled.
IN NO EVENT SHALL MASIMO BE LIABLE TO BUYER OR ANY OTHER PERSON FOR ANY INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES (INCLUDING WITHOUT LIMITATION LOST PROFITS), EVEN IF ADVISED OF THE POSSIBILITY THEREOF. IN NO EVENT SHALL MASIMO’S LIABILITY ARISING FROM ANY PRODUCTS SOLD TO BUYER (UNDER A CONTRACT, WARRANTY, TORT OR OTHER CLAIM) EXCEED THE AMOUNT PAID BY BUYER FOR THE LOT OF PRODUCT(S) INVOLVED IN SUCH CLAIM. IN NO EVENT SHALL MASIMO BE LIABLE FOR ANY DAMAGES ASSOCIATED A PRODUCT THAT HAS BEEN REPROCESSED, RECONDITIONED OR RECYCLED. THE LIMITATIONS IN THIS SECTION SHALL NOT BE DEEMED TO PRECLUDE ANY LIABILITY THAT, UNDER APPLICABLE PRODUCTS LIABILITY LAW, CANNOT LEGALLY BE PRECLUDED BY CONTRACT.

NO IMPLIED LICENSE
This single-patient use sensor is licensed to you under the patents owned by Masimo for single-patient use only. By acceptance or use of this product, you acknowledge and agree that no license is granted for use of this product with more than a single patient.

CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.
For professional use. See instructions for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.
The following symbols may appear on the product or product labeling:

SYMBOL

DEFINITION

---|---|---|---|---|---
| Follow instructions for use| | Separate collection for electrical and electronic equipment (WEEE).| **| Caution: Federal law (USA) restricts this device to sale by or on the order of a physician
**| Consult instructions for use| | Lot code| | Mark of conformity to European Medical Device Directive 93/42/EEC
| Manufacturer| | Catalogue number (model number)| | Authorized representative in the European community
| Date of manufacture YYYY-MM-DD| | Masimo reference number| | Body weight
| Use -by YYYY-MM-DD| | Serial number| | Storage temperature range
| Do not re-use/ Single patient use only| | Leave on for no more than 24 hours| | Keep dry
| Non-Sterile| | Greater than| | Do not use if package is damaged
| Not made with natural rubber latex| | Less than| | Atmospheric pressure limitation
| Fragile, handle with care| | Caution| | Storage humidity limitation
**| Instructions/Directions for Use/Manuals are available in electronic format @http://www.Masimo.com/TechDocs
Note: eIFU is not available in all countries.**