Radius PPG™ Wireless SpO2 Sensors

Product Overview

The Masimo Radius PPG™ is a wireless sensor system designed for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It consists of three main parts: the Radius PPG wireless receiver, the Radius PPG reusable chip, and the Radius PPG adhesive sensor. This system is intended for use with devices containing Masimo technology, specifically MX Version 7.14.8.x or higher.

Indications for Use

Masimo Radius PPG™ is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (SpO2) and pulse rate (PR). It is designed for use with adult, pediatric, and neonatal patients in both no-motion and motion conditions, and for patients who are well or poorly perfused. The device can be used in hospital, hospital-type facilities, and home environments.

Contraindications

The Radius PPG is contraindicated for patients who exhibit allergic reactions to foam rubber products and/or adhesive tape.

Warnings, Cautions, and Notes

• Verify compatibility of the monitor, cable, and sensor before use to prevent degraded performance or patient injury.
• Discontinue use if the sensor shows visible defects, discoloration, or damage. Never use a damaged sensor or one with exposed electrical circuitry.
• Keep sensor components away from children as small items may pose a choking hazard.
• Frequently check the sensor site (or per clinical protocol) to ensure adequate adhesion, circulation, skin integrity, and correct optical alignment.
• Exercise caution with poorly perfused patients; skin erosion and pressure necrosis can occur if the sensor is not moved frequently. Assess sites hourly for such patients.
• Routinely check circulation distal to the sensor site.
• Ensure the sensor attachment strap site is checked frequently for securement, circulation, and skin integrity.
• Inaccurate readings may occur with very low perfusion; readings may be lower than core arterial oxygen saturation.
• Do not use tape to secure the sensor, as this can restrict blood flow, cause inaccurate readings, skin damage, pressure necrosis, or damage the sensor.
• Sensors applied too tightly or that become tight due to edema can cause inaccurate readings and pressure necrosis.
• Misapplied sensors or partially dislodged sensors may cause incorrect measurements.
• Incorrect sensor types can lead to inaccurate or no readings.
• Ensure proper venous outflow from the monitored site to avoid under-reading arterial oxygen saturation due to venous congestion. Do not place the sensor below heart level.
• Venous pulsations or pulsations from intra-aortic balloon support can affect pulse rate readings. Verify patient's pulse rate against ECG heart rate.
• Route cables carefully to prevent patient entanglement or strangulation.
• Avoid placing the sensor on extremities with an arterial catheter or blood pressure cuff.
• During full body irradiation, keep the sensor out of the radiation field to avoid inaccurate readings.
• Do not use the sensor during MRI scanning or in an MRI environment.
• High ambient light sources (e.g., surgical lights, bilirubin lamps, fluorescent lights, infrared heating lamps, direct sunlight) can interfere with sensor performance. Cover the sensor site with opaque material if necessary.
• Elevated levels of Carboxyhemoglobin (COHb), Methemoglobin (MetHb), or Total Bilirubin can lead to inaccurate SpO2 measurements. Laboratory analysis is recommended if suspected.
• Abnormal fingers, intravascular dyes (e.g., indocyanine green, methylene blue), or external coloring (e.g., nail polish, acrylic nails) may cause inaccurate SpO2 readings.
• Severe anemia, low arterial perfusion, motion artifact, hypocapnic or hypercapnic conditions, and EMI radiation interference can also cause inaccurate readings.
• Routinely verify the wireless connection for continued monitoring.
• Repeat pairing before monitoring when using multiple Radius PPG sensors to ensure proper connection.
• Do not soak or immerse the sensor in any liquid solution to prevent damage.
• Do not modify or alter the sensor, as this may affect performance and accuracy.
• Do not attempt to reuse, reprocess, or recycle Masimo sensors or patient cables on multiple patients, as this may damage electrical components and potentially harm patients.
• High oxygen concentrations may predispose premature infants to retinopathy; carefully select upper alarm limits for oxygen saturation.
• Keep the Radius PPG within the recommended range from the host device to maintain connection.
• Relocate devices away from sources of radio frequency interference (RFI) such as electrocautery, diathermy, cellular telephones, wireless PCs/tablets, pagers, RFID devices, MRI, and electromagnetic security systems.
• Replace the sensor when a 'replace sensor' message is displayed or a low SIQ message persists after troubleshooting.
• The sensor is provided with X-Cal® technology to minimize inaccurate readings and loss of monitoring. Discard the sensor after single-patient use.

Instructions for Use

a) Verification of components

Gather all required components for monitoring. Refer to Figure 1.

Figure 1 Description: Figure 1 displays the Radius PPG system components: A. Radius PPG adhesive sensor, B. Radius PPG wireless Bluetooth receiver, C. Radius PPG reusable chip, and D. Radius PPG reusable chip holder for the device.

b) Initial setup

1. Turn on the patient monitor.
2. Plug the wireless receiver cable into the patient monitor. The light on the wireless receiver will be white. Refer to Figure 2.
3. Attach the wireless receiver to the side of the patient monitor using the provided adhesive. Refer to Figure 3.
4. Ensure the attachment does not cover speakers or mounting holes. Refer to Figure 4.
5. Attach the chip holder near the receiver on the patient monitor. Refer to Figure 5.
6. Verify that the wireless receiver is attached and plugged in, and that the chip holder is attached to the patient monitor. Refer to Figure 6.

Figure 2 Description: Figure 2 shows the wireless receiver cable being plugged into the patient monitor, with the receiver's indicator light shown as white.

Figure 3 Description: Figure 3 illustrates the process of attaching the wireless receiver to the side of the patient monitor using adhesive.

Figure 4 Description: Figure 4 provides guidance on placement, advising to avoid obstructing speakers or mounting holes when attaching the module.

Figure 5 Description: Figure 5 shows the chip holder being attached near the receiver on the patient monitor.

Figure 6 Description: Figure 6 confirms the correct setup, showing the wireless receiver attached and connected, and the chip holder in place on the patient monitor.

c) Sensor site selection

• Radius PPG ADT (Adult Sensor > 30 kg): Preferred site is the middle or ring finger of the non-dominant hand.
• Radius PPG PDT (Pediatric Sensor 10–50 kg): Preferred site is the middle or ring finger of the non-dominant hand.
• Radius PPG INF (Infant Sensor 3–10 kg): Preferred site is the great toe. Alternatively, the toe next to the great toe or the thumb can be used.
• Radius PPG NEO (Neonatal/Adult Sensor < 3 kg): Preferred site is the foot. Alternatively, the sensor can be applied across the palm and back of the hand.
• Radius PPG NEO (Neonatal/Adult Sensor > 40 kg) / INF (Infant Sensor 10–20 kg): Preferred site is the middle or ring finger of the non-dominant hand.

d) Attaching the strap to the patient

1. Open the pouch and remove the single-patient-use sensor.
2. Peel off the plastic tab to activate the battery, and discard the tab. Refer to Figure 7.
3. Thread the attachment strap through the plastic loop hole. Wrap the strap around the patient's wrist or limb (based on selected sensor site) and attach using the hook-and-loop closure. Refer to Figures 8a and 8b.
4. Remove the backing from the sensor, if present.

Figure 7 Description: Figure 7 shows the plastic tab being peeled off to activate the sensor's battery.

Figure 8a Description: Figure 8a illustrates threading the attachment strap through its plastic loop hole.

Figure 8b Description: Figure 8b shows the attachment strap wrapped around a patient's limb and secured with hook-and-loop closure.

e) Attaching the sensor to the patient

ADT sensor for ADULTS (> 30 kg) and PDT sensor for PEDIATRICS (10–50 kg)

1. Orient the sensor so the detector is placed first. Place the fingertip on the dashed line, ensuring the fleshy part covers the finger outline and detector window. Refer to Figure 9a.
2. Press the adhesive wings onto the finger, one at a time. Fold the sensor over the finger, positioning the emitter window over the fingernail. Secure the wings around the finger. Complete coverage of the detector window is essential for accurate data. Refer to Figure 9b.
3. Ensure the emitter and detector are vertically aligned (indicated by black lines). Reposition if necessary. Refer to Figure 9c.

Figure 9a Description: Figure 9a shows the correct placement of an adult/pediatric sensor on a finger, aligning the detector window with the fleshy part of the fingertip.

Figure 9b Description: Figure 9b illustrates pressing the adhesive wings onto the finger and folding the sensor over, positioning the emitter window over the fingernail.

Figure 9c Description: Figure 9c demonstrates the proper vertical alignment of the emitter and detector windows on the finger, marked by black lines.

Inf sensor for INFANTS (3–10 kg)

1. Direct the sensor cable along the top of the foot. Position the detector on the fleshy pad of the great toe. Alternatively, the toe next to the great toe or the thumb can be used. Refer to Figure 10a.
2. Wrap the adhesive wrap around the toe, positioning the emitter on the nail bed of the great toe. Complete coverage of the detector window is essential for accurate data. Refer to Figure 10b.
3. Ensure the emitter window aligns directly opposite the detector on the toe. Verify correct positioning and reposition if necessary. Refer to Figure 10c.

Figure 10a Description: Figure 10a shows the infant sensor placement on a great toe, with the detector on the fleshy pad and the cable directed along the top of the foot.

Figure 10b Description: Figure 10b illustrates wrapping the adhesive wrap around the toe to position the emitter on the nail bed.

Figure 10c Description: Figure 10c shows the alignment of the emitter window opposite the detector window on the infant's toe.

Neo sensor for NEONATES (< 3 kg)

1. For fragile skin, the adhesive's stickiness can be reduced by dabbing the adhesive areas with a cotton ball or gauze. Refer to Figure 11a.
2. Direct the sensor cable toward the ankle (or wrist). Apply the sensor around the lateral aspect of the foot (or hand), aligned with the fourth toe (or finger). Complete coverage of the detector window is essential for accurate data. Refer to Figure 11b.
3. Wrap the adhesive/foam wrap around the lateral aspect of the foot (or hand), ensuring the emitter window aligns directly opposite the detector. Maintain proper alignment while securing the sensor. Verify correct positioning and reposition if necessary. Refer to Figure 11c.

Figure 11a Description: Figure 11a provides a tip for fragile skin, suggesting reducing adhesive stickiness for the neonatal sensor.

Figure 11b Description: Figure 11b shows the neonatal sensor applied to the lateral aspect of the foot, aligned with the fourth toe.

Figure 11c Description: Figure 11c illustrates securing the neonatal sensor on the foot with an adhesive/foam wrap, ensuring emitter and detector alignment.

Neo sensor for ADULTS (> 40 kg) / Inf sensor for INFANTS (10–20 kg)

1. Direct the sensor cable along the top of the hand. Position the detector on the fleshy part of the finger. Refer to Figure 12a.
2. Alternatively, the sensor may be applied to the toe (not shown).
3. Wrap the adhesive wrap around the finger, aligning the emitter window on the top of the finger directly opposite the detector. Complete coverage of the detector window is essential for accurate data. Refer to Figure 12b.
4. Check the sensor for correct positioning and reposition if necessary. Refer to Figure 12c.

Figure 12a Description: Figure 12a shows the sensor placement on a finger for adult/infant use, positioning the detector on the fleshy part.

Figure 12b Description: Figure 12b illustrates wrapping the adhesive wrap around the finger to align the emitter window opposite the detector.

Figure 12c Description: Figure 12c shows the final check for correct sensor positioning on the finger.

f) Adjusting the sensor cable

With the sensor attached, adjust the thin flexible sensor cable. Refer to Figures 13a and 13b.

Figure 13a Description: Figure 13a shows the adjustment of the flexible sensor cable.

Figure 13b Description: Figure 13b provides another view of the sensor cable adjustment.

g) Pairing the reusable transmitter chip with the wireless receiver

1. Ensure the device is powered on. Refer to Figure 14.
2. Hold the reusable chip to the indent on the wireless receiver until the Bluetooth symbol turns green. Refer to Figure 15.
3. Insert the reusable chip into the sensor attachment strap until a tactile or audible click confirms connection. Refer to Figure 16.
4. Verify the light on the wireless receiver turns blue.

Figure 14 Description: Figure 14 shows the device powered on, ready for the pairing process.

Figure 15 Description: Figure 15 illustrates holding the reusable chip to the wireless receiver's indent until the Bluetooth symbol turns green.

Figure 16 Description: Figure 16 shows the reusable chip being inserted into the sensor attachment strap until it clicks into place.

h) Reattachment

The sensor may be reapplied to the same patient if the emitter and detector windows are clear and the adhesive still adheres to the skin.

i) Applying replacement tape (for Neo sensor only)

1. Remove and discard the existing tape. Refer to Figure 17.
2. Remove the replacement tape from its release liner. Refer to Figure 18.
3. Position the replacement tape over the sensor, aligning the emitter component with the sensor cable. Refer to Figure 19.

Figure 17 Description: Figure 17 shows the removal of existing tape from the neonatal sensor.

Figure 18 Description: Figure 18 shows the new replacement tape being removed from its liner.

Figure 19 Description: Figure 19 illustrates placing the replacement tape over the sensor, aligning it with the sensor cable.

j) Disconnecting

1. Push down on the tab to release the reusable chip from the sensor. Refer to Figure 20.
2. After cleaning, store the reusable chip in the chip holder attached to the patient monitor.
3. Discard the adhesive sensor and strap.

Figure 20 Description: Figure 20 shows the process of releasing the reusable chip from the sensor by pushing a tab.

Cleaning

To surface clean the reusable chip and wireless receiver:

• Wipe all surfaces with one of the following: 70% Isopropyl alcohol, 10% (1:10) chlorine bleach to water solution, or Quaternary ammonium chloride solution.
• Inspect for visible debris and repeat cleaning as needed.
• Dry cleaned parts before use.

Cautions: Do not use undiluted bleach or other unrecommended solutions. Do not immerse the components in liquid. Do not sterilize by irradiation, steam, autoclave, or ethylene oxide.

Light Indicator Guide

Specifications

Environmental Specifications

• Storage/Transport Temperature: 0°C to 50°C @ ambient humidity
• Sensor Storage/Transport Temperature: -40°C to +70°C @ ambient humidity
• Chip and Receiver Operating Temperature: 0°C to 40°C @ ambient humidity
• Storage/Transport Humidity: 5% to 95% non-condensing
• Operating Humidity: 5% to 95% non-condensing
• Atmospheric Pressure: 540 to 1060 mBar @ ambient temperature and humidity

Battery Life

• Battery Life: 96 hours in typical continuous usage

Wireless Technology Information

• Modulation Type: GFSK
• Max. Output Power: +8 dBm
• Frequency Range: 2402 MHz - 2480 MHz
• Antenna Peak Gain: 0 dBi
• Recommended Range: 100 ft (~30 meters) line-of-sight
• Quality of Service (QoS): Delay <30 seconds
• Security: Proprietary binary protocol

Compatibility

This sensor is intended for use only with devices containing Masimo SET oximetry or pulse oximetry monitors licensed to use Masimo sensors. Radius PPG sensors are compatible with Masimo technology boards and software versions MX version 7.14.8.x and higher. Use with other devices may result in no or improper performance. For compatibility information, refer to www.Masimo.com.

Warranty

Masimo warrants to the initial buyer that these products will be free of defects in materials and workmanship for six (6) months when used according to directions. Single use products are warranted for single patient use only. Masimo disclaims all other warranties, including those of merchantability or fitness for a particular purpose. Masimo's sole obligation is to repair or replace the product at its option. This warranty does not cover products used in violation of instructions, misused, neglected, or damaged. It also does not cover products connected to unintended devices, modified, or disassembled. Reprocessed, reconditioned, or recycled sensors/cables are not covered. Masimo shall not be liable for incidental, indirect, special, or consequential damages, or for damages exceeding the amount paid by the buyer for the product.

Performance Specifications

When used with Masimo SET pulse oximetry monitors or licensed modules, the Radius PPG sensors have the following specifications:

* See Bland and Altman. Agreement between methods of measurement with multiple observations per individual Journal of Biopharmaceutical Statistics (2007) vol. 17 pp. 571-582.

¹ Masimo SET Technology validated for no motion accuracy in human blood studies on healthy volunteers across 70%-100% SpO2 against a laboratory co-oximeter.

² Masimo SET Technology validated for motion accuracy in human blood studies on healthy volunteers during rubbing and tapping motions (2-4 Hz, 1-2 cm amplitude) and non-repetitive motion (1-5 Hz, 2-3 cm amplitude) across 70%-100% SpO2 against a laboratory co-oximeter.

³ Masimo SET Technology validated for low perfusion accuracy in benchtop testing against simulators with signal strengths > 0.02% and transmission > 5% for saturations 70%-100%.

⁴ Masimo SET Technology validated for pulse rate accuracy (25-240 bpm) in benchtop testing against simulators with signal strengths > 0.02% and transmission > 5% for saturations 70%-100%.

⁵ Neonate and Preterm sensor accuracy validated on adult volunteers; 1% added for fetal hemoglobin properties.

The emitted wavelengths range from 600 to 1000 nm, with peak optical power less than 15 mW.

Symbols and Definitions

The following symbols may appear on the product or labeling:

• Follow instructions for use [i]
• Consult instructions for use [i]
• NON STERILE
• Temperature Range: -40°C to +70°C
• Atmospheric Pressure Range: +500 hPa to +1060 hPa (375 mmHg to 795 mmHg)
• Humidity Range: 5%-95% RH
• LATEX: Not made with natural rubber latex
• Manufacturer: Masimo Corporation
• Date of manufacture: YYYY-MM-DD
• Use-by: YYYY-MM-DD
• Do not discard: [recycle symbol]
• Caution: [exclamation mark in triangle]
• Do not re-use / Single patient use only
• Separate collection for electrical and electronic equipment (WEEE): [WEEE symbol]
• Lot code: [lot code symbol]
• Catalogue number (model number): [tag symbol]
• Masimo reference number: [document symbol]
• Light Emitting Diode (LED): LED emits light when current flows through
• Greater than: >
• Less than: <
• Storage humidity limitation: 5%-95% RH
• Bluetooth: [Bluetooth logo]
• Federal Communications Commission (FCC) Licensing: [FCC logo]
• Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
• Mark of conformity to European Medical Device Directive 93/42/EEC: [CE mark]
• Authorized representative in the European community: [EC REP symbol]
• Body weight: [scale symbol]
• Storage temperature range: [thermometer symbol]
• Keep dry: [umbrella symbol]
• Do not use if package is damaged: [broken package symbol]
• Atmospheric pressure limitation: [barometer symbol]
• Fragile, handle with care: [broken glass symbol]
• Identifies unit has been registered as a radio device
• IP22: Protected against solid foreign objects ≥ 12.5 mm and vertically falling water drops when tilted 15 degrees.
• IPX4: Protected against solid foreign objects ≥ 1.0 mm and effects of temporary immersion in water.

Instructions/Directions for Use/Manuals are available in electronic format @ www.Masimo.com/TechDocs. Note: eIFU is not available in all countries.

Patents: www.masimo.com/patents.htm

Electromagnetic Compatibility (EMC) and RF Information

Recommended Separation Distances

The ME Equipment is intended for use in a controlled electromagnetic environment. To prevent electromagnetic interference, maintain a minimum distance between portable and mobile RF communication equipment (transmitters) and the ME Equipment as recommended below, according to the maximum output power of the communication equipment.

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.

Performance Specifications (ARMS Values)

The table below shows ARMS (Accuracy Root Mean Square) values measured using the Radius PPG sensors under no motion conditions with Masimo Technology in a clinical study.

* See Bland and Altman. Agreement between methods of measurement with multiple observations per individual Journal of Biopharmaceutical Statistics (2007) vol. 17 pp. 571-582.

Bland Altman Plot Description: The plot shows SpO2 (SaO2) vs. (SpO2+SaO2)/2 for Radius PPG No Motion, with lines indicating the mean difference, upper 95% limit of agreement (1.98%), and lower 95% limit of agreement (-2.91%).

Manufacturer Information

Manufacturer: Masimo Corporation
52 Discovery Irvine, CA 92618 USA
Website: www.masimo.com