Contraindications - Masimo Radius T Mode D'emploi

Radius T°
Wearable Thermometer
Single patient use only
Prior to using this sensor, the user should read and understand the Operator's Manual for the Device or Application and
this Directions for Use.
INDICATIONS
Radius T°™ wearable thermometer is intended for single-use, continuous noninvasive measurement of body
temperature on the upper chest via wireless communication to a smart device application or compatible
patient monitor (i.e. Masimo Root
The Radius T° is indicated for single-use, continuous body temperature measurements of persons 5 years of
age or older in hospitals, hospital-type facilities, and home environments.

CONTRAINDICATIONS

Radius T° sensors are contraindicated for patients who exhibit allergic reactions to adhesive tape.
DESCRIPTION
Radius T° sensors are battery powered, disposable sensors that are designed to continuously provide body
temperatures that are approximations of oral temperatures. The sensors are adhered to the patient's skin to
continuously transmit temperature measurement data via Bluetooth communication to a compatible device
or application.
Note: Radius T° sensors are to only be used with compatible devices or applications. Verify compatibility before
use to ensure the sensor functions properly.
WARNINGS, CAUTIONS, AND NOTES
• Only use Masimo authorized applications with Radius T°. Using unauthorized applications or devices with
Radius T° may result in no or incorrect readings.
• The Radius T° Sensor should not be used as the sole basis for diagnosis or therapy decisions. It must be
used in conjunction with clinical signs and symptoms.
• The sensor should be free of visible defects, discoloration, and damage. If the sensor is discolored or
damaged, discontinue use. Never use a damaged sensor or one with exposed electrical circuitry.
• Do not use the sensor during MRI scanning or in a MRI environment as it may result in physical harm.
• Do not use Radius T° sensors in the presence of flammable anesthetics or other flammable substances in
combination with air, oxygen-enriched environments or nitrous oxide to avoid risk of exposure.
• Avoid contact with the sensor during defibrillation. Defibrillation may result in temporary loss of
temperature readings.
• Using during electrocautery may cause no or incorrect temperature readings.
• Avoid placing the sensor over compromised skin, excessive hair, implants, ports, subcutaneous or dermal
fillers or scar tissue, as this may result in incorrect readings.
• Do not apply over or near pacemakers to avoid any potential interference from the Bluetooth
communication.
• Radius T° should not be used near electrical equipment that may affect the sensor's ability from working
properly.
• Check the sensor site to ensure skin integrity and to avoid damage or irritation to the skin.
• Incorrect readings may be caused by sensors that are not placed on an appropriate application site.
• Radius T° may not reflect the actual body temperature when used on patients undergoing treatments that
may alter their normal temperature regulation (e.g. therapeutic hypothermia, antipyretics).
• Avoid direct heating or cooling of the Radius T° sensor. Localized temperature exposure of the sensor may
result in no or incorrect readings.
• Sensors that become partially dislodged may cause no or incorrect readings.
• Rapid or large changes in ambient temperature may cause no or incorrect readings.
• Periodically check the sensor site for proper adhesion to minimize the risk of incorrect or no readings.
• Change or modifications that are not expressly approved by the manufacturer could void the user's
authority to operate the equipment.
• Do not modify or alter the sensor in any way. Alteration or modification may affect performance and/or
accuracy.
• To prevent damage, do not soak or immerse the sensor in any liquid solution.
™
D I R E C T I O N S F O R U S E
Not made with natural rubber latex
LATEX
PCX-2108A
02/13
, Masimo Rad-97 ).
® ®
3
en
Non-sterile
10714E-eIFU-0122