Operator's Manual

en
Radius T°™
Patient Temperature Sensor
DIRECTIONS FOR USE
Single patient use only
LATEX
PCX-2108A
02/13
Not made with natural rubber latex Non-sterile
Prior to using this sensor, the user should read and understand the Operator’s Manual for the Device and
this Directions for Use.
INDICATIONS
Radius T°™ disposable sensors are intended for spot-check or continuous noninvasive monitoring
of body temperature for use on Adult and Pediatric patients, 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
measure body temperature. The sensors are capable of adhering to patient’s skin and
continuously transmitting temperature measurement data via Bluetooth communication
protocol to a host device.
Note: Radius T° sensors are designed to be compatible with specic Masimo devices. See
Compatibility section.
WARNINGS, CAUTIONS, AND NOTES
• Radius T° sensors are used with specific monitors. Verify compatibility before use to ensure
the sensors function properly.
• Always ensure settings including alarms are appropriate for each patient and facility’s
protocols prior to use.
• 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.
• Avoid contact with the sensor during defibrillation.
• Do not use tape to secure the sensor to the site. Use of additional tape can cause skin
damage, and/or pressure necrosis or damage the sensor.
• Sensors that become partially dislodged may cause incorrect readings.
• Rapid or large changes in ambient temperature may affect the measurement.
• Inaccurate readings may be caused by misaligned sensor and/or EMI interference.
• Check the sensor site to ensure skin integrity and to avoid damage or irritation to the skin.
• The site must be checked frequently or per clinical protocol to ensure adequate circulation,
skin integrity and correct alignment.
• Exercise caution with poorly perfused patients. Assess site frequently and move the sensor
if there are signs of tissue ischemia.
• Periodically check the sensor site for proper adhesion to minimize the risk of inaccurate or
no 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 use the sensor during surgical procedures.
• 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.
• 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.
• Replace the sensor when a replace sensor or equivalent message is displayed consistently.
Consult monitoring device operator’s manual for more information.
• Do not place the Radius T° near electrical equipment that may affect the device, preventing
it from working properly.
• Only use Masimo authorized devices with Radius T°. Using unauthorized devices with
Radius T° may result in damage to the device and/or patient injury.
• 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.
• The frequency bands of this device (2.4 GHz) are only for indoor use, in accordance with
international telecommunication requirements.
• Change or modifications that are not expressly approved by the manufacturer could void
the user’s authority to operate the equipment.
INSTRUCTIONS
A) Site Selection
1. Refer to Fig. 1. The preferred site is on the left side of the patients chest, below the collarbone.
• Chose a site on the left side of the chest where the skin is clean of debris and dry prior
Radius T°™
Patient Temperature Sensor
Masimo Corporation
52 Discovery
Irvine, CA 92618
USA
www.masimo.com
Manufacturer:
© 2020 Masimo Corporation
301349/10714A-0720
EU Authorized Representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
to sensor placement.
• The site should be hair-free, cleaned of debris and dry prior to sensor placement. Use
an alcohol swab to clean the application site, if needed.
• Ensure orientation and location of the sensor on the patient matches the sensor site
location in the Masimo device settings.
B) Applying the sensor
1. Open the package and remove the sensor.
Note: Do not remove the release liner at this point.
2. Refer to Fig. 2. Pull to remove the plastic battery tab and dispose of the tab properly.
3. Refer to Fig. 3. Move the sensor close to the host device, to enable Bluetooth pairing.
Note: Refer to the host device Operator’s Manual for complete instructions.
4. Clean and dry the sensor application site.
5. Refer to Fig. 4. Pull off the release liner from the sensor and dispose of the liner properly.
6. Apply the sensor on the patient to the selected application site.
7. Apply pressure all around the perimeter of the sensor to ensure the adhesive is secure to the
patient’s skin. Avoid contact with the exposed sensor adhesive.
8. Ensure that the skin of the patient is relaxed and not stretched in any way and that there are
no skin folds under the sensor pad.
C) Sensor Reapplication
Note: Radius T° sensors are designed for removal and reapplication no more than one (1)
time over the life of the product.
1. Clean and dry the sensor application site.
2. Gently wipe the exposed sensor adhesive with an alcohol swab and allow to dry to
restore
the adhesive properties.
3. Follow steps 6 through 8 from above to re-apply the sensor.
D) Removing the Sensor
1. Peel gently to remove the sensor from the patient.
Note: Disposal of Product: Comply with local laws in the disposal of the sensor, battery and
its accessories.
LIGHT INDICATOR GUIDE
Color Sensor Description Next steps
No light
--- • Sensor power is off.
• Confirm battery pull tab has been removed to
activate the battery.
• Replace the sensor.
Green
ashing • Sensor is on and waiting to pair with host device.
• Follow instructions to pair with the host
device.
Blue
ashing
• Sensor is waiting for user confirmation that
desired sensor was paired to the host device.
• Verify sensor attachment so that host device
can receive data.
solid
• Successful pairing of sensor and host device.
• Host device successfully receiving data.
Orange
ashing • Low sensor battery • Consider replacing the sensor..
Red
ashing
• Depleted sensor battery
• Hardware or sensor failure, sensor blinking board
failure code
• Replace the sensor..
SPECIFICATIONS
The Radius T° sensors have the following specications:
Temperature measurement accuracy ±0.3°C in the range of 34°C to 40°C.
Application Site Upper Chest, below the left collarbone
Product Use Life Minimum of 8 days, continuous use
Battery Life Minimum of 8 days (192 hours) of continuous run time