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![Radical-7 Chapter 1: Technology Overview The Radical-7 uses a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated blood, blood with carbon monoxide, oxidized blood and blood plasma. The Radical-7 utilizes a sensor with various light-emitting diodes (LEDs) that pass light through the site to a diode (detector). Signal data is obtained by passing various visible and infrared lights (LEDs, 500 to 1400nm) through a capillary bed (for example, a fingertip, a hand, a foot) and measuring changes in light absorption during the blood pulsatile cycle. This information may be useful to clinicians. The maximum radiant power of the strongest light is rated at ≤ 25 mW. The detector receives the light, converts it into an electronic signal and sends it to the Radical-7 for calculation. 1. Light Emitting Diodes (LEDs) (7 + wavelengths) 2. Detector Once the Radical-7 receives the signal from the sensor, it utilizes proprietary algorithms to calculate the patient’s functional oxygen saturation (SpO2 [%]), blood levels of carboxyhemoglobin (SpCO [%]), methemoglobin (SpMet [%]), total hemoglobin concentration (SpHb [g/dL]) and pulse rate (PR). The SpCO, SpMet and SpHb measurements rely on a multi-wavelength calibration equation to quantify the percentage of carbon monoxide and methemoglobin and the concentration of total hemoglobin in arterial blood. In an ambient temperature of 35º C the maximum skin surface temperature has been measured at less than 106º F (41º C), verified by Masimo sensor skin temperature test procedure. www.masimo.com 26 Masimo DRAFT 9 25 13](https://usermanual.wiki/Masimo/RADICAL7/User-Guide-2390878-Page-28.png)
![Radical-7 Chapter 1: Technology Overview General Description for Total Arterial Oxygen Content (CaO2) Oxygen (O2) is carried in the blood in two forms, either dissolved in plasma or combined with hemoglobin. The amount of oxygen in the arterial blood is termed the oxygen content (CaO2) and is measured in units of ml O2/dL blood. One gram of hemoglobin (Hb) can carry 1.34 ml of oxygen, whereas 100 ml of blood plasma may carry approximately 0.3 ml of oxygen*. The oxygen content is determined mathematically as: CaO2 = 1.34 (ml O2/g Hb) x Hb (g/dL) x HbO2 + PaO2 (mm Hg) x (0.3 ml O2/100 mm Hg/dL) Where HbO2 is the fractional arterial oxygen saturation and PaO2 is the partial pressure of arterial oxygen. For typical PaO2 values, the second part of the above equation (PaO2 [mm Hg] x [0.3 ml O2/ 100 mm Hg/dL]) is approximately 0.3 ml/dL. Furthermore, for typical carboxyhemoglobin and methemoglobin levels, the functional saturation (SpO2) as measured by a pulse oximeter is given by: SpO2 = 1.02 x HbO2 *Martin, Laurence. All You Really Need to Know to Interpret Arterial Blood Gases, Second Edition. New York: Lippincott Williams & Wilkins, 1999. General Description for SpOC The above approximations result in the following reduced equation for oxygen content via the Pulse CO-Oximeter: SpOC (ml/dL*) = 1.31 (ml O2/g Hb) x SpHb (g/dL) x SpO2 + 0.3 ml/dL *When ml O2/g Hb is multiplied by g/dL of SpHb, the gram unit in the denominator of ml/g cancels the gram unit in the numerator of g/dL resulting in ml/dL (ml of oxygen in one dL of blood) as the unit of measure for SpOC. See Safety Information, Warnings, and Cautions on page 11. General Description for Carboxyhemoglobin (SpCO) Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of carboxyhemoglobin concentration (SpCO) in arterial blood. It relies on the same basic principles of pulse oximetry (spectrophotometry) to make its SpCO measurement. The measurement is obtained by placing a sensor on a patient, usually on the fingertip for adults and the hand or foot for infants. The sensor connects either directly to the Pulse CO-Oximetry instrument or through an instrument patient cable. The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data as percentage value for the SpCO, which reflect blood levels of carbon monoxide bound to hemoglobin. Successful Monitoring for SpCO A stable SpCO reading is associated with correct sensor placement, small physiological changes during the measurement and acceptable levels of arterial perfusion in the patient’s www.masimo.com 28 Masimo DRAFT 9 25 13](https://usermanual.wiki/Masimo/RADICAL7/User-Guide-2390878-Page-30.png)
![Radical-7 Chapter 1: Technology Overview fingertip (measurement site). Physiological changes at the measurement site are mainly caused by fluctuations in the oxygen saturation, blood concentration and perfusion. General Description for Methemoglobin (SpMet) Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of methemoglobin concentration (SpMet) in arterial blood. It relies on the same basic principles of pulse oximetry (spectrophotometry) to make its SpMet measurement. The measurement is obtained by placing a sensor on a patient, usually on the fingertip for adults and the hand or foot for infants. The sensor connects either directly to the Pulse CO-Oximetry instrument or through a patient cable. The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data as percentage value for the SpMet. Successful Monitoring for SpMet A stable SpMet reading is associated with correct sensor placement, small physiological changes during the measurement and acceptable levels of arterial perfusion in the patient’s fingertip (measurement site). Physiological changes at the measurement site are mainly caused by fluctuations in the oxygen saturation, blood concentration and perfusion. See Safety Information, Warnings, and Cautions on page 11. SpCO, SpMet, and SpHb Measurements During Patient Motion The Radical-7 displays measurements of SpCO, SpMet, and SpHb during patient motion. However, because of the changes in the physiological parameters such as blood volume, arterial-venous coupling, etc. that occur during patient motion, the accuracy of such measurements may not be reliable during excessive motion. In this case, the measurement value for SpCO, SpMet, or SpHb displays as dashes (---) and a message (Low SpCO SIQ, Low SpMet SIQ, or Low SpHb SIQ) displays to alert the clinician that the instrument does not have confidence in the value due to poor signal quality caused by excessive motion or other signal interference. rainbow Acoustic Monitoring (RAM) Technology rainbow Acoustic Monitoring (RAM) continuously measures a patient’s respiration rate based on airflow sounds generated in the upper airway. The Acoustic Sensor translates airflow sounds generated in the upper airway to an electrical signal that can be processed to produce a respiration rate, measured as breaths per minute. Respiratory sounds include sounds related to respiration such as breath sounds (during inspiration and expiration), adventitious sounds, cough sounds, snoring sounds, sneezing sounds, and sounds from the respiratory muscles [1]. These respiratory sounds often have different characteristics depending on the location of recording [2] and they originate in the large airways where air velocity and air turbulence induce vibration in the airway wall. These vibrations are transmitted, for example, through www.masimo.com 29 Masimo DRAFT 9 25 13](https://usermanual.wiki/Masimo/RADICAL7/User-Guide-2390878-Page-31.png)
![Radical-7 Chapter 1: Technology Overview the lung tissue, thoracic wall and trachea to the surface where they may be heard with the aid of a stethoscope, a microphone or more sophisticated devices. rainbow Acoustic Monitoring Architecture The following figure illustrates how a respiratory sound produced by a patient can be turned into a numerical measurement that corresponds to a respiratory parameter. Patient Sensor Acquisition System Respiratory airflow to sound Sound to electrical signal Electrical signal to digital signal Signal Processing Envelope Detection RRa Estimation Digital signal to respiratory measurement Patient The generation of respiratory sounds is primarily related to turbulent respiratory airflow in upper airways. Sound pressure waves within the airway gas and airway wall motion contribute to the vibrations that reach the body surface and are recorded as respiratory sounds. Although the spectral shape of respiratory sounds varies widely from person to person, it is often reproducible within the same person, likely reflecting the strong influence of individual airway anatomy [2-6]. Sensor The sensor captures respiratory sounds (and other biological sounds) much like a microphone does. When subjected to a mechanical strain, (e.g., surface vibrations generated during breathing), the sensor becomes electrically polarized. The degree of polarization is proportional to the applied strain. The output of the sensor is an electric signal that includes a sound signal that is modulated by inspiratory and expiratory phases of the respiratory cycle. Acquisition System The acquisition system converts the electric signal provided by the sensor into a digital signal. This format allows the signal to be processed by a computing device. www.masimo.com 30 Masimo DRAFT 9 25 13](https://usermanual.wiki/Masimo/RADICAL7/User-Guide-2390878-Page-32.png)
![Radical-7 Chapter 1: Technology Overview Signal Processing The digital signal produced by the acquisition system is converted into a measurement that corresponds to the respiratory parameter of interest. As shown in the previous figure, this can be performed by, for example, determining the digital signal envelope or outline which in turn may be utilized to determine the respiratory rate. In this way, a real-time, continuous breath rate parameter can be obtained and displayed on a monitor which, in many cases, may be real-time and continuous. The respiratory cycle envelope signal processing principle is similar to methods that sample airway gasses and subsequently determine a respiratory rate. [1] A.R.A. Sovijärvi, F. Dalmasso, J. Vanderschool, L.P. Malmberg, G. Righini, S.A.T. Stoneman. Definition of terms for applications of respiratory sounds. Eur Respir Rev 2000; 10:77, 597-610. [2] Z. Moussavi. Fundamentals of respiratory sounds analysis. Synthesis lectures on biomedical engineering #8. Morgan & Claypool Publishers, 2006. [3] Olsen, et al. Mechanisms of lung sound generation. Semin Respir Med 1985; 6: 171-179. [4] Pastercamp H, Kraman SS, Wodicka GR. Respiratory sounds – Advances beyond the stethoscope. Am J Respir Crit Care Med 1977; 156: 974-987. [5] Gavriely N, Cugell DW. Airflow effects on amplitude and spectral content of normal breath sounds. J Appl Physiol 1996; 80: 5-13. [6] Gavrieli N, Palti Y, Alroy G. Spectral characteristics of normal breath sounds. J Appl Physiol 1981; 50: 307-314. www.masimo.com 31 Masimo DRAFT 9 25 13](https://usermanual.wiki/Masimo/RADICAL7/User-Guide-2390878-Page-33.png)
![Chapter 8: Specifications The following chapter contains specifications for the Radical-7 Handheld, compatible Docking Stations, and the Standalone system. Performance Measurement Range SpO2 0% to 100% SpMet 0% to 99.9% SpCO 0% to 99% SpHb 0 g/dL to 25 g/dL SpOC 0 ml of O2/dL to 35 ml of O2/dL of blood Pulse Rate 25 bpm to 240 bpm Perfusion Index 0.02% to 20% Pleth Variability Index 0% to 100% Respiration Rate 4 breaths per minute to 69 breaths per minute Accuracy Oxygen Saturation Accuracy [1] No Motion 60% to 80% Adults, Infants, Pediatrics ±3% No Motion [2] 70% to 100% www.masimo.com 109 Masimo DRAFT 9 25 13](https://usermanual.wiki/Masimo/RADICAL7/User-Guide-2390878-Page-111.png)
![Radical-7 Chapter 8: Specifications Adults, Infants, Pediatrics ± 2% Neonates ± 3% Motion [3] 70% to 100% Adults, Infants, Pediatrics, Neonates ± 3% Low Perfusion [4] Adults, Infants, Pediatrics, Neonates ± 2% Pulse Rate Accuracy Pulse rate range 25 bpm to 240 bpm No Motion Adults, infants, pediatrics, neonates ± 3 bpm Motion [4] Adults, infants, pediatrics, neonates ± 5 bpm Low Perfusion Adults, infants, pediatrics, neonates ± 3 bpm Carboxyhemoglobin Saturation Accuracy [1] Adults, infants, pediatrics 1% to 40% ± 3% Methemoglobin Saturation Accuracy [1] Adults, infants, pediatrics, neonates 1% to 15% ± 1% Total Hemoglobin Accuracy [6] Adults, pediatrics 8 g/dL to 17 g/dL ±1 g/dL Respiratory Rate Accuracy (RRa) [11] Adults 4 breaths per minute to 69 breaths per minute, ±1 breath per minute www.masimo.com 110 Masimo DRAFT 9 25 13](https://usermanual.wiki/Masimo/RADICAL7/User-Guide-2390878-Page-112.png)
![Radical-7 Chapter 8: Specifications Resolution Parameter Step Size %SpO2 1% %SpCO 1% %SpMet 0.1% SpHb g/dL 0.1 g/dL Pulse Rate 1 beats per minute Respiration Rate 1 breath per minute Electrical Standalone AC Power requirements 100 to 240 VAC, 47 to 63 Hz Power consumption 55 VA Fuses 1 Amp, Fast Acting, Metric, (5x20mm), 250V Handheld Battery Type Lithium ion Capacity 4 hours [7] Time 3 hours Environmental Operating Temperature 41°F to 104°F (5°C to 40°C) Transport/Storage Temperature -40°F to 158°F (-40°C to 70°C) [8] www.masimo.com 111 Masimo DRAFT 9 25 13](https://usermanual.wiki/Masimo/RADICAL7/User-Guide-2390878-Page-113.png)
![Radical-7 Chapter 8: Specifications Operating Humidity 5% to 95%, non-condensing Operating Altitude 500 mbar to 1060 mbar -1000 ft to 18,000 ft (-304 m to 5,486 m) Physical Characteristics Dimensions Handheld 8.9” x 3.5” x 2.1” (22.6 cm x 8.9cm x 5.3 cm) Standalone 3.5” x 10.5” x 7.7” (8.9 cm x 26.7 cm x 19.6 cm) Weight Handheld 1.2 lbs. (0.54 kg) Docking Station (RDS-1, RDS-2, RDS-3) 2.5 lbs. (1.14 kg) Standalone (RDS-1, RDS-2, RDS-3) 3.8 lbs. (1.73 kg) Trending • 96 hours of trending at 2-second resolution • > 10 days of trending at 10-second resolution • Output to serial printer or other serial instruments Sensitivity NORM, MAX, and APOD [10] Alarms Parameter Alarm Range SpO2 1% to 99% SpCO 1% to 98% www.masimo.com 112 Masimo DRAFT 9 25 13](https://usermanual.wiki/Masimo/RADICAL7/User-Guide-2390878-Page-114.png)
![Radical-7 Chapter 8: Specifications Citations [1] SpO2, SpCO, and SpMet accuracy was determined by testing on healthy adult volunteers in the range 60% to 100% SpO2, 0% to 40% SpCO, and 0% to 15% SpMet against a laboratory CO-Oximeter. SpO2 and SpMet accuracy was determined on 16 neonatal NICU patients ranging in age from 7 days to 135 days old and weighting between 0.5 kgs and 4.25 kgs. Seventy-nine (79) data samples were collected over a range of 70% to 100% SaO2 and 0.5% to 2.5% HbMet with a resultant accuracy of 2.9% SpO2 and 0.9% SpMet. Contact Masimo for testing specifications. [2] The Masimo Rainbow SET technology with Masimo sensors has been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor. This variation equals plus or minus one standard deviation which encompasses 68% of the population weight. [3] The Masimo Rainbow SET technology with Masimo sensors has been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies while performing rubbing and touching motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population. [4] The Radical-7 has been validated for low perfusion accuracy in bench-top testing against a Biotek Index 2TM* simulator and Masimo's simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70-100%. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population. [5] Masimo Rainbow SET technology with Masimo sensors has been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the population. [6] SpHb accuracy has been validated on healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation in the range of 8 g/dL to 17 g/dL SpHb against a laboratory CO-Oximeter. The variation equals plus or minus one standard deviation which encompasses 68% of the population. The SpHb accuracy has not been validated with motion or low perfusion. [7] This represents approximate run time at the lowest indicator brightness and pulse tone turned off using a fully charged battery. [8] If the batteries are to be stored for extended periods of time, it is recommended that they be stored between -20°C to +30°C, and at a relative humidity less than 85%. If stored for a prolonged period at environmental conditions beyond these limits, overall battery capacity may be diminished, and lifetime of the batteries may be shortened. [9] With FastSat the averaging time is dependent on the input signal. For the 2 and 4 second settings the averaging time may range from 2-4 and 4-6 seconds, respectively. [10] Maximum sensitivity mode fixes perfusion limit to 0.02%. [11] Respiration rate accuracy for the Masimo Acoustic Respiration Sensor and Instrument has been validated for the range of 4 to 70 breaths per minute in bench top testing. Clinical validation for up to 30 breaths per minute was also performed with the Masimo Acoustic Respiration Sensor and Instrument. *Registered trademark of Fluke Biomedical Corporation, Everett, Washington. www.masimo.com 122 Masimo DRAFT 9 25 13](https://usermanual.wiki/Masimo/RADICAL7/User-Guide-2390878-Page-124.png)
