Directions For Use - Masimo RD SedLine Mode D'emploi

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RD SedLine® Patient Cable

Reusable

DESCRIPTION

The RD SedLine Patient Cable transfers analog EEG signals collected from the Sensor to the Module for processing. The Patient

Cable is a reusable cable and may be used from patient to patient.

Always refer to the operator's manual for complete instructions or additional instructions.

The RD SedLine Patient Cable is compatible with the RD SedLine EEG Sensor.

INSTRUCTIONS

A) Connecting

To connect the Patient Cable to the Module

1. Align the ridged Patient Cable connector end with the available Module connector end.

2. Push to insert.

To connect the Patient Cable to the Sensor

1. Align the yellow indicator connector on the end of the RD SedLine Patient Cable with the yellow indicator on the Sensor

Connector.

2. Refer to Fig. 1. Push together until the connections fit securely.

B) Disconnecting the Sensor

To disconnect the Patient Cable from the Module

•

Gently pull the Patient Cable out of the Module by grasping the patient cable connector end.

To disconnect the Patient Cable from the Sensor

•

Gently pull the Sensor out of the Patient Cable connector from the Sensor's connector end.

CLEANING

1. Remove the sensor from the patient and disconnect it from the patient cable.

2. Clean the surface of the cable by wiping it with a 70% isopropyl alcohol pad, quaternary ammonium chloride solution, or

a 10% (1:10) chlorine bleach to water solution.

3. Wipe all surfaces of the cable.

4. Saturate another cloth or gauze pad with sterile or distilled water and wipe all surfaces of the cable.

5. Dry the cable by wiping all surfaces with a clean cloth or dry gauze pad.

The surface of the cable has been tested to be chemically resistant to the following solutions: Quaternary Ammonium

Chloride solution wipe, Accelerated Hydrogen Peroxide, Chlorhexidine, Cidex, 70% and 90% Isopropyl Alcohol, and 10%

(1:10) chlorine bleach to water solution.

CAUTION

• Do not immerse the connector on the cable in any liquid solution.

• Do not sterilize by irradiation, steam, autoclave, or ethylene oxide.

• Do not clean with chemicals not approved above.

SPECIFICATIONS

Cable length

Patient module connector

Sensor connector

ENVIRONMENTAL

Storage/Transport Temperature

Operating Temperature

Storage/Transport Humidity

Operating Humidity

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.