Contraindications - Masimo Radius T Handbuch

Radius T°™
Patient Temperature Sensor
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°™ disposable sensors are intended for continuous noninvasive measurements of body temperature for use on Adult
and Pediatric patients, 5 years of age or older, in hospitals, hospital-type facilities, and home environments.
Note: Radius T° is not FDA approved or cleared.

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.
• Do not attempt to sterilize by irradiation, steam, autoclave or ethylene oxide as it will damage the sensor.
• Do not attempt to reuse on multiple patients, reprocess, recondition or recycle Masimo sensors or patient cables as
these processes may damage the electrical components, potentially leading to patient harm.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should
be used no closer than 30 cm (12 inches) to any part of the Radius T°, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
D I R E C T I O N S F O R U S E
LATEX
Not made with natural rubber latex
PCX-2108A
02/13
3
en
Non-sterile
10714C-eIFU-0920