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Do not use a headband or other device to secure the sensor to the patient.
WARNING: To reduce the risks associated with incorrect system or sensor use:
•
Limit use of the sensor to 24 hours. Extended use may compromise skin, cause degradation of material
or performance.
•
Avoid exposing the temperature monitoring sensor, sensor cable, power supply, and control unit to surgical
skin surface preparation solutions or other fluids.
•
Use an additional independent thermometer to measure body temperature during intentional hyperthermia or
hypothermia therapy.
•
Confirm unanticipated temperature reading with an independent thermometer, if needed.
•
Do not reposition the sensor; repositioning may weaken the sensor adhesive, damage the sensor, or
compromise the device performance.
•
Avoid placing the sensor in the center of the forehead as this may affect sensor accuracy.
WARNING: To reduce the risks associated with exposure to biohazards:
•
Follow facilities policies and procedures for disposal of contaminated materials.
•
Always perform the decontamination procedure prior to returning the temperature monitoring system for
service and prior to disposal.
WARNING: To reduce the risks associated with entanglement:
•
Do not leave pediatric patients unattended while using the temperature monitoring system.
CAUTION: To reduce the risks associated with skin maceration:
•
Do not use the sensor on damaged or compromised skin.
CAUTION: To reduce the risks associated with cross-contamination:
•
Clean the sensor cable before connecting to a new sensor.
CAUTION: To reduce the risks associated with injury:
•
Mount the control unit at a height no higher than 84" (213 cm) above floor.
•
Use the provided hook-and-loop or foam adhesive to secure the control unit stand to any hard, flat, and clean
surface (use only the 3M provided/specified control unit mounting materials).
CAUTION: To reduce the risks associated with impact and facility medical device damage:
•
Do not use the control unit as a handle to transport or to move the device to which it is attached.
•
Do not initiate temperature monitoring unless the control unit is safely placed on a hard, flat surface and is
securely mounted.
CAUTION: To reduce the risks associated with environmental contamination:
•
Follow applicable regulations when disposing of this device or any of its electronic components.
CAUTION: To reduce the risks associated with electromagnetic compatibility:
•
Consult the troubleshooting guide found in Section 5 of this manual if performance of the system is degraded
due to the Electromagnetic Disturbances.
NOTICE
1.
The temperature monitoring system meets medical electronic interference requirements. If radio frequency
interference with other equipment should occur, connect the unit to a different power source.
2.
Protection against electrostatic discharge (ESD) is important when working with the temperature monitoring
system. Always be mindful of the immediate work area and any potentially hazardous ESD situations that
could impact temperature monitoring system performance.
3.
To avoid temperature monitoring system damage that may impact performance:
•
Do not store the control unit and system components in a wet or damp place.
•
Do not spray cleaning solutions onto the control unit or into the sensor cable connector.
•
Do not immerse the control unit or system components in any liquid, use a dripping wet cloth for
cleaning, or subject them to any sterilization process.
•
Do not use solvents, such as acetone or thinner to clean the control unit; avoid abrasive cleaners.
•
Cleaning should be performed in accordance with hospital practices for cleaning OR equipment. After
every use wipe the device surfaces, cords, and cables. Avoid getting liquid into electronic ports.
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