Masimo Radius T User Manual

Radius T°
™
Continuous Thermometer
U S E R ' S G U I D E
Download the Masimo Radius T° app before using this product.
For help, go to www.masimo.com/radius-t for additional tips and tutorials, a full list of supported
devices, warranty, troubleshooting, and customer support.

INDICATIONS

™
Radius T° is intended for the continuous noninvasive measurement of body temperature for
use on Adult and Pediatrics, 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 people 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 user's skin to continuously transmit temperature measurement data via
Bluetooth communication to the Masimo Radius T° 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.

SAFETY PRECAUTIONS

• Do not self-diagnose or self-medicate on the basis of the measurements. Always consult
your doctor.
• The Masimo sensor is to only be used with a Masimo authorized app. Connection to other
devices may not allow the sensor to work properly.
• Do not use the sensor if it has visible defects, discoloration, exposed wiring or appears
damaged. Otherwise the sensor may not work properly.
• Avoid placing the sensor over compromised skin, excessive hair, implants, ports, skin 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.
• Periodically check the sensor site for proper adhesion to minimize the risk of incorrect or
no readings.
• Avoid direct heating or cooling of the Radius T° sensor. Localized temperature exposure of
the sensor may result in no or incorrect readings.
• 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 people undergoing
treatments that may alter their normal temperature regulation (e.g. therapeutic
hypothermia, antipyretics).
• Rapid or large changes in ambient temperature may cause no or incorrect readings.
• 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 people. Reprocessing, reconditioning, or recycling
may damage the sensor.
• 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.
• Keep the Radius T° away from electrical equipment that emits radio frequencies to
minimize radio interference. Radio interference may result in no or inaccurate readings.
• Do not use the sensor during MRI scanning or in a MRI environment as it may result in
physical harm.

INSTRUCTIONS

1) Remove sensor from pouch and pull tab to activate battery. Refer to Fig. 1.
2) Pair the sensor to your phone
a. Download and open the Masimo Radius T° app.
b. Make sure your phone Bluetooth is turned on. Once battery tab is removed, your sensor is
available for Bluetooth pairing. Refer to Fig. 2.
c. A solid blue light indicates the sensor is connected. (See LIGHT INDICATOR GUIDE/
TROUBLESHOOTING)
d. Check your phone application to ensure the sensor is communicating correctly.
Note: Readings may take up to 15 minutes to appear on the phone application after first
applying the sensor.
e. Periodically check your sensor or phone application for a solid blue light to confirm that it
is connected.
3) Select a site for application
a. Choose a site on the upper chest below the left collar bone. Skin should be hair-free, clean
and dry before applying the sensor.
en 4) Remove release liner from the sensor
a. Remove plastic film from the back of the sensor. Refer to Fig. 3.
Note: Avoid contact with the exposed sensor adhesive.
5) Apply the sensor
a. Place the sensor on your selected application site. Refer to Fig. 4.
Note: Ensure that the skin is not stretched in any way and that there are no skin folds under
the sensor pad.
b. Press around the adhesive to ensure it is secure.
6) Reapply the sensor
Note: The sensor is designed to be removed and reapplied no more than one (1) time over
the life of the product.
a. Clean and dry the sensor application site.
b. Gently wipe the exposed sensor adhesive with an alcohol wipe and allow to dry to restore
the adhesive properties.
c. Follow Step 5 from above to re-apply the sensor.
7) Remove the sensor
a. Peel gently to remove the sensor from the skin.
Note: Disposal of Product: Comply with local laws in the disposal of the sensor, battery and
its accessories.

LIGHT INDICATOR GUIDE/TROUBLESHOOTING

Color Sensor
No light
--- • Sensor power is off.
• Sensor is on and waiting to pair with your
Green
flashing
mobile phone.
• Sensor is waiting for you to confirm that
flashing desired sensor was paired to your mobile
phone.
Blue
• Successful pairing of sensor and mobile
solid phone.
• Mobile phone successfully receiving data.
Orange
flashing • Low sensor battery
• Depleted sensor battery
Red
flashing
• Hardware or sensor failure, sensor
blinking board failure code
For additional help, contact Masimo Customer Support at (800) 916-1270. Local contact information can be found
at www.masimo.com/radius-t.

PRODUCT PERFORMANCE

The Radius T° sensors have the following specifications:
Temperature measurement accuracy
Application Site
Product Use/Battery Life
The laboratory accuracy of Radius T⁰ is ±0.1⁰C (0.18⁰F) for an input surface temperature range of 25⁰C to 43⁰C (77⁰F
to 109.4⁰F).
Radius T⁰ has been validated on 112 subjects, 5 years of age or older, against a reference clinical thermometer. Results
have shown a clinical bias of -0.17⁰C (-0.30⁰F) with limits of agreement ≤ 0.96⁰C (1.73⁰F).

ENVIRONMENTAL

Storage/Transport Temperature
Operating Temperature
Storage/Transport Humidity
Operating Humidity
Atmospheric Pressure
Radius T°™
Continuous Thermometer
Manufacturer:
Masimo Corporation
52 Discovery
Irvine, CA 92618
USA
www.masimo.com
© 2020 Masimo Corporation
Description
• Confirm battery pull tab has been
removed to activate the battery.
• Replace the sensor.
• Follow instructions to pair with your
mobile phone.
• Verify the sensor is properly attached
to the wearer's body so that mobile
phone can receive data.
• Consider replacing the sensor.
• Replace the sensor.
±0.1°C in the range of 25°C to 43°C
Upper Chest, below the left collarbone
Minimum of 8 days, (192 hours) of continuous run time
-20°C to 50°C @ ambient humidity
10°C to 40°C @ ambient humidity
10% RH to 95% RH (non-condensing) @ ambient temperature
10% RH to 95% RH (non-condensing) @ ambient temperature
700 to 1060 hPa @ ambient temperature and humidity
Next steps
301864/10890A-1020