Masimo RADIUS T Patient Temperature sensor User Manual

Masimo RADIUS T Patient Temperature sensor

HOW TO 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 specific 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

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 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.

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.

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.

Removing the Sensor

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

—

|

•     Sensor power is off.

| •     Confirm battery pull tab has been removed to activate the battery.

•     Replace the sensor.

Green| flashing| •     Sensor is on and waiting to pair with host device.| •     Follow instructions to pair with the host device.

Blue

|

flashing

| •     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| flashing| •     Low sensor battery| •     Consider replacing the sensor..
Red|

flashing

| •     Depleted sensor battery

•     Hardware or sensor failure, sensor blinking board failure code

|

•     Replace the sensor..

SPECIFICATIONS

The Radius T° sensors have the following specifications:

ENVIRONMENTAL

temperature
Operating Humidity| 10% RH to 95% RH (non-condensing) @ ambient temperature

WIRELESS TECHNOLOGY INFORMATION

FCC Statment

FCC ID are as follows: FCC ID: VKF-RADIUST, IC ID: 7362A- RADIUS
CAUTION: In order to maintain Bluetooth connectivity with the host device ensure that Radius T° is within specified distance and line of sight of the host device.
RF Radiation Exposure Statement: This equipment has been exempted from FCC RF radiation exposure testing and IC RSS 102 RF radiation exposure limits set forth for an uncontrolled environment.

Note:
This device complies with part 15 of FCC Rules and Industry Canada’s license- exempt RSSs. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Note:
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Consult the dealer or an experienced radio/TV technician for help.

Note:
When using Radius T° consideration should be taken to local government frequency allocations and technical parameters to minimize the possibility of interference to/from other wireless devices.

RECOMMENDED SEPARATION DISTANCES

RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE AND MOBILE RF COMMUNICATION EQUIPMENT AND THE ME EQUIPMENT

The ME Equipment is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ME Equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ME Equipment as recommended below, according to the maximum output power of the communication equipment.

RATED MAXIMUM OUTPUT POWER OF TRANSMITTER (W)

| SEPARATION DISTANCE ACCORDING TO FREQUENC Y OF TRANSMITTER (M)
150 kHz to 80 MHz d = 1.17√P| 80 MHz to 800 MHz d = 1.17√P| 800 MHz a 2.5 GHz

d = 2.33*√P

0.01| 0.12| 0.12| 0.23
0.1| 0.37| 0.37| 0.74
1| 1.17| 1.17| 2.33
10| 3.7| 3.7| 7.37
100| 11.7| 11.7| 23.3
For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

GUIDANCE AND MANUFACTURER’S DECLARATION- ELECTROMAGNETIC EMISSIONS

The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the ME Equipment should assure that it is used in such an environment.
EMISSION TEST| COMPLIANCE| ELECTROMAGNETIC ENVIRONMENT – GUIDANCE

RF Emissions CISPR 11

| ****

Group 1

| ****

The ME Equipment must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

RF Emissions CISPR 11| ****

Class B

| ****

Suitable for use in all establishments, including domestic environments.

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

The ME Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the   ME Equipment should assure that it is used in such an environment.
IMMUNITY TEST| IEC 60601 TEST LEVEL| COMPLIANCE LEVEL| ELECTROMAGNETIC ENVIRONMENT – GUIDANCE

Electrostatic discharge (ESD)

IEC 61000-4-2

|

+8 kV contact

+15 kV air

|

+8 kV contact

+15 kV air

|

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Power frequency (50  /  60 Hz) magnetic field. IEC 61000-4-8

|

30 A/m

|

30 A/m

| Guidance –

Power frequency magnetic  fields  should  be at levels characteristic of typical location in a typical hospital environment.

Portable and mobile RF communications equipment should be used no closer to any part of the ME Equipment, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
IMMUNITY TEST| IEC 60601 TEST LEVEL| COMPLIANCE LEVEL| RECOMMENDED SEPARATION DISTANCE
---|---|---|---
Radiated RF IEC 61000-4-3| 10 V/m

80 MHz to 2.5 GHz

| ****

10 V/m

| ****

80 MHz to 800 MHz

800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ME Equipment is used exceeds the applicable RF compliance level above, the ME Equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ME Equipment.

b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.

TEST SPECIFICATIONS FOR ENCLOSURE PORT IMMUNITY TO RF WIRELESS COMMUNICATION EQUIPMENT

TEST

FREQUENC Y

| BAND (A) (MHZ)| ****

SERVICE (A)

| ****

MODULATION (B)

| MAXIMUM POWER (W)| DISTANCE (M)| IMMUNITY TEST LEVEL (V/M)

385

| ****

380-395

| ****

TETRA 400

| Pulse modulation (b) 18 Hz| ****

1,8

| ****

0,3

| ****

27

450

| ****

430-470

| ****

GMRS 460,

FRS 460

| FM (c) +/- 5 kHz deviation 1 kHz sine| ****

2

| ****

0,3

| ****

28

710| ****

704-787

| ****

LTE Band 13, 17

| ****

Pulse modulation (b) 217 Hz

| ****

0,2

| ****

0,3

| ****

9

745
780
810| ****

800-960

| GSM 800/900, TETRA 800,

iDEN 820,

CDMA 850, LTE

Band 5

| ****

Pulse modulation (b) 18 Hz

| ****

2

| ****

0,3

| ****

28

870
930
1 720| ****

1 700-1 990

| GSM 1800;

CDMA 1900;

GSM 1900; DECT; LTE

Band 1, 3. 4. 35:

UMTS

| ****

Pulse modulation (b) 217 Hz

| ****

2

| ****

0,3

| ****

28

1 845
1 970

2 450

| ****

2 400-2 570

| Bluetooth, WLAN, 802.11

b/g/n, RFID 2450, LTE

Band 7

| ****

Pulse modulation (b) 217 Hz

| ****

2

| ****

0,3

| ****

28

5 240| ****

5 100-5 800

| ****

WLAN 802.11

a/n

| ****

Pulse modulation (b) 217 Hz

| ****

0,2

| ****

0,3

| ****

9

5 500
5 785
Note: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
(a) For some services, only the uplink frequencies are included.

(b) The carrier shall be modulated use a 50% duty cycle square wave signal.

(c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.

COMPATIBILITY

This sensor is intended for use only with devices containing Masimo technology. Each sensor is designed to operate correctly only on the systems from the original device manufacturer. Use of this sensor with other devices may result in no or improper performance. For Compatibility Information Reference: www. Masimo.com

WARRANTY

Masimo warrants to the initial buyer only that these products, when used in accordance with the directions provided with the Products by Masimo, will be free of defects in materials and workmanship for a period of six (6) months. Single use products are warranted for single patient use only.
THE FOREGOING IS THE SOLE AND EXCLUSIVE WARRANTY APPLICABLE TO THE PRODUCTS SOLD BY MASIMO TO BUYER. MASIMO EXPRESSLY DISCLAIMS ALL OTHER ORAL, EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE. MASIMO’S SOLE OBLIGATION AND BUYER’S EXCLUSIVE REMEDY FOR BREACH OF ANY WARRANTY SHALL BE, AT MASIMO’S OPTION, TO REPAIR OR REPLACE THE PRODUCT.

WARRANTY EXCLUSIONS

This warranty does not extend to any product that has been used in violation of the operating instructions supplied with the product, or has been subject to misuse, neglect, accident or externally created damage. This warranty does not extend to any product that has been connected to any unintended instrument or system, has been modified, or has been disassembled or reassembled. This warranty does not extend to sensors or patient cables that have been reprocessed, reconditioned or recycled.
IN NO EVENT SHALL MASIMO BE LIABLE TO BUYER OR ANY OTHER PERSON FOR ANY INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES (INCLUDING WITHOUT LIMITATION LOST PROFITS), EVEN IF ADVISED OF THE POSSIBILITY THEREOF. IN NO EVENT SHALL MASIMO’S LIABILITY ARISING FROM ANY PRODUCTS SOLD TO BUYER (UNDER A CONTRACT, WARRANTY, TORT OR OTHER CLAIM) EXCEED THE AMOUNT PAID BY BUYER FOR THE LOT OF PRODUCT(S) INVOLVED IN SUCH CLAIM. IN NO EVENT SHALL MASIMO BE LIABLE FOR ANY DAMAGES ASSOCIATED A PRODUCT THAT HAS BEEN REPROCESSED, RECONDITIONED OR RECYCLED. THE LIMITATIONS IN THIS SECTION SHALL NOT BE DEEMED TO PRECLUDE ANY LIABILITY THAT, UNDER APPLICABLE PRODUCTS LIABILITY LAW, CANNOT LEGALLY BE PRECLUDED BY CONTRACT.

NO IMPLIED LICENSE

This single-patient sensor is licensed to you under the patents owned by Masimo for single-patient use only. By acceptance or use of this product, you acknowledge and agree that no license is granted for use of this product with more than a single patient. After single-patient use, discard sensor. Purchase or possession of this sensor confers no express or implied license to use the sensor with any device which is not separately authorized to use Masimo sensors.

CAUTION:
FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.
For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. If you encounter any serious incident with product, please notify the competent authority in your country and the manufacturer.

References

• Masimo - Home
• Masimo - Home
• Masimo - Patent Information

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