MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER
Device Facts
| Record ID | K080238 |
|---|---|
| Device Name | MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER |
| Applicant | Masimo Corporation |
| Product Code | DQA · Cardiovascular |
| Decision Date | May 12, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. In addition, the Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous noninvasive monitoring data obtained from the Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) to multi-parameter devices for the display of those devices. The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. The Masimo Rainbow SET® Rad-57 t Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masimo Rainbow SET® Rad-57 t Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
Device Story
Masimo Rainbow SET Radical 7, Rad 87, and Rad 57t are pulse CO-oximeters using multi-wavelength sensors (620-1270 nm) to measure arterial blood constituents. Sensors collect optical signals from capillary beds (fingertip, hand, foot); photodetectors convert light absorption changes into electronic signals. Masimo Signal Extraction Technology (SET) processes these signals to calculate SpO2, SpCO, SpMet, SpHb, and pulse rate. Devices are used in hospitals, mobile, and home environments by clinicians to assess patient status and guide interventions. Output includes real-time numerical values, pleth waveforms, and trends displayed on the device; Radical 7 and Rad 87 also provide analog/serial outputs for multi-parameter monitors. Benefits include continuous, noninvasive monitoring of hemoglobin species and perfusion status, aiding in early detection of hypoxemia, carbon monoxide poisoning, or methemoglobinemia.
Clinical Evidence
Clinical validation performed on healthy adult volunteers (n=unspecified) and neonatal NICU patients (n=16, age 7-135 days). Accuracy validated against laboratory CO-oximeters for SpO2, SpCO, SpMet, and SpHb. SpO2 accuracy: ±2% (no motion), ±3% (motion). SpHb accuracy: ±1 g/dL (7-17 g/dL range). Pulse rate accuracy: ±3 bpm (no motion), ±5 bpm (motion). Bench testing used for low perfusion and pulse rate validation.
Technological Characteristics
Multi-wavelength LED sensors (620-1270 nm); photodetector sensing; microprocessor-controlled signal processing; Polycarbonate/ABS construction; AC/battery power; RS-232/analog/SatShare connectivity; IPX1 ingress protection; continuous operation mode.
Indications for Use
Indicated for continuous noninvasive monitoring of SpO2, pulse rate, SpCO, SpMet, and SpHb in adult, pediatric, and neonatal patients. Applicable for patients with motion or no-motion, and well or poorly perfused states in hospital, mobile, and home settings.
Regulatory Classification
Identification
An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.
Predicate Devices
- Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and Accessories (K061204)
- Masimo Rainbow SET® Rad 57cm/m Pulse CO-Oximeters and Accessories (K053477)
- Radiometer America, Inc. OSM3 Hemoximeter (K853990)
Submission Summary (Full Text)
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K080238
MAY 12 2008
| Submitted by: | Masimo Corporation<br>40 Parker<br>Irvine, CA 92618<br>(714) 297-7000<br>FAX (714) 297-7001 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondence: | James J. Cronin, Vice President, Regulatory Affairs |
| Contact for this Submission: | Marguerite Thomlinson, Manager, Regulatory Affairs |
| Date Summary Prepared: | January 28, 2008 |
| Trade Name | Masimo Rainbow SET® Radical 7 CO-Oximeter |
| Common Name | Pulse Oximeter and Sensor |
| Classification Name | Oximeter (74DQA)<br>Transducer and Electrode Cable (including connector) (74DSA)<br>Carbon monoxide test system (JKS)(862.3220) |
| Substantially Equivalent Devices | Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and Accessories<br>510(k) Number - K061204<br>Masimo Rainbow SET® Rad 57cm/m Pulse CO-Oximeters and Accessories<br>510(k) Number - K053477<br>Radiometer America, Inc. OSM3 Hemoximeter<br>510(k) Number - K853990 |
### Description of the Device
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The Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories (Radical 7), the Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories (Rad 87), and the Masino Rainbow SET® Rad 57t Pulse CO-Oximeter and accessories (Rad 57t) have the noninvasive monitoring Masimo Rainbow SET technology.
The Radical 7 provides nonitoring of arterial oxygen saturation (%SpO2), pulse rate, carboxyhemoglobin saturation (%SpCO), methemoglobin saturation (%SpMet), and/or total hemoglobin concentration (g/dl SpHb). Other information displayed by the Radical 7 include: Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), Total Arterial Oxygen Content (CaO2), alarm status, alarm silence, battery life, sensor status, trends, and pleth waveform. The Radical 7 has output interfaces include: SatShare connection to multi-parameter monitors, Nurse Call analog output, and RS-232 serial output.
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The Rad 87 provides noninvasive monitoring of arterial oxygen saturation (%SpO2), pulse rate, carboxyhemoglobin saturation (%SpCO), methemoglobin saturation (%SpMet), and/or total hemoglobin concentration (g/dl SpHb). Other information displayed by the Rad 87 include: Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), Total Arterial Oxygen Content (CaO2), alarm status, alarm silence, battery life, sensor status, and trends. The Rad 87 has output interfaces include: Nurse Call analog output, and RS-232 serial output.
The Rad 57t provides noninvasive monitoring of arterial oxygen saturation (%SpO2), pulse rate, cand/or total hemoglobin concentration (g/dl SpHb). Other information displayed by the Rad 87 include: Low Signal IQ (Low SIQ), Perfusion Index (PI), Total Arterial Oxygen Content (CaO2), alarm status, alarm silence, battery life, sensor status, and trends.
The Radical 7, Rad 87, and Rad 57t are intended to be used with Masimo LNOP series of oximety sensors and patient cables, Masimo LNCS series of oximetry sensors and patient cables, Masimo Rainbow (SpCO/SpMet) sensors and patient cables, and Masimo Rainbow (SpCO/SpMet/SpHb) sensors and patient cables.
### Intended Use/Indications for Use
The Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. In addition, the Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous noninvasive monitoring data obtained from the Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) to multi-parameter devices for the display of those devices.
The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories are indicated for the continuous noninyasive monitoring of functional oxygen saturation of arterial hemoglobin (SpOz), pulse rate (measured by an SpO2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
The Masimo Rainbow SET® Rad-57 t Pulse CO-Oximeter and accessories are indicated for the continuous noninyasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO-sensor) and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masimo SET® Rad-57 t Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motions, and for patients who are well or poorly perfused in hospitals, hospitaltype facilities, mobile, and home environments.
### Principles of Operation
### SpO2 General Description
Pulse oximetry is a continuous and non-invasive method of measuring the level of arterial oxygen saturation in blood. The measurement is taken by placing a sensor on a patient, usually on the fingertip for adults, and the hand or foot for neonates. The sensor connects directly to the pulse oximetry instrument or with a patient cable. The sensor collects signal data from the patient and sends it to the instrument displays the calculated data in tw
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ways: 1) as a percent value for arterial oxygen saturation (SpO2), and 2) as a pulse rate (PR). Figure 1 shows the general monitoring setup ..
### SpCO, SpMet, and SpHb General Description
Instruments containing Masimo Rainbow SET technology also offer a continuous and non-invasive method of measuring the levels of carboxyhemoglobin concentration (SpCO), methemoglobin concentration (SpMet) and total hemoglobin in blood (SpHb). It relies on the same principles of pulse oximetry to make SpCO, SpMet and SpHb measurements. The measurements are taken by placing a sensor on a patient, usually on the fingertip for adults. The sensor connects directly to the instrument or with 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 values for the SpCO and the SpMet and as grams/deciliter (g/dL) for SpHb. Instruments containing Masimo Rainbow SET technology are a combined SpO2, SpMet and SpHb monitor with the same setup as that of a pulse oximeter, shown above, and can display percentage or concentration values for SpCO, SpMet and SpHb as well as SpO2 and pulse rate.
Pulse oximetry is governed by the following principles:
- Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood), carboxyhemoglobin 1. (blood with carbon monoxide content), and methemoglobin (blood with oxidized hemoglobin content) species differ in their absorption of visible and infrared light.
- The amount of arterial blood in tissue changes with your pulse (photoplethysography). Therefore, the ં મં amount of light absorbed by the varying quantities of arterial blood changes as well.
Instruments containing Masimo Rainbow SET technology use a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated blood, blood with carbon monoxide, blood with oxidized hemoglobin and blood plasma. Signal data is obtained by passing various visible and infrared lights (LED's, 620 to 1270 mm) through a capillary bed (for example, a fingertip, a hand, a foot) and measuring changes in light absorption during the blood pulsatile cycle (see Figure 3). The photodetector receives the light, converts it into an electronic signal and sends it to the Radical 7/ Rad 87/ Rad-57t for calculation.
Once the instrument containing Rainbow SET technology receives the signal from the sensor, it utilizes Masimo Signal Extraction Technology (SET) to calculate the patient's functional oxygen saturation (SpO2), fractional concentration of carboxyhemoglobin (SpCO), fractional concentration of methemoglobin (SpMet), total hemoglobin concentration (SpHb) and pulse rate (PR). In instruments containing Masimo Rainbow SET technology. multi-wavelength calibration equations are used to estimate the saturation and concentration values.
#### Method of Operation
The Radical 7, Rad 87, and the Rad 57t have the same method of operation. The instrument is turned on. An oximetry sensor is attached to a patient's finger and one end of a patient cable is connected to the sensor and the other end connected to the instrument.
The monitor will begin continuously displaying the patient's pulse rate, and SpO2 value. Depending on the type and or configuration of the instrument, monitoring information would also include SpCO, SpMet, SpHb, PVI, and/or CaO2. The practitioner can the information to help assess the condition of the patient and as an aide in determining if any intervention is required by the practitioner.
Once the practitioner determines the patient no longer requires monitoring, the cable is disconnected from the sensor, the CO-oximetry sensor is removed (and disposed of if it is a single use device), and the power to the monitor is turned off.
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### Specifications
The specifications for the Radical 7, Rad 87, and Rad 57t are:
| FEATURES | SPECIFICATIONS | TYPE OF<br>PULSE CO-OXIMETER |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Display Ranges | | |
| | Saturation (SpO2): 0% - 100%<br>Pulse Rate (bpm): 25 - 240 bpm<br>Total Hemoglobin (SpHb): 0-25 g/dl<br>Total Oxygen Concentration (CaO2):<br>1-100 ml/dl<br>Perfusion Index: 0.02% - 20% | Radical 7<br>Rad 87<br>Rad 57t |
| | Carboxyhemoglobin Saturation<br>(SPCO): 0-99%<br>Methemoglobin Saturation (SpMet):<br>0-99.9%<br>Pleth Variability Index: 0% - 100% | Radical 7<br>Rad 87 |
| Rate | See Footnotes 1, 2, 3, 4, and 5 | |
| Accuracy - SpO2<br>During No Motion<br>Conditions | Adults, Pediatrics, Infants: 60% - 80%<br>$\pm$ 3%<br>Adults, Pediatrics, Infants, Neonates:<br>70% - 100% $\pm$ 2%<br>Adults, Pediatrics, Infants, Neonates:<br>0% - 69% unspecified | Radical 7<br>Rad 87<br>Rad 57t |
| Accuracy - SpO2<br>During Motion Conditions | Adults, Pediatrics, Infants, Neonates:<br>70% - 100% $\pm$ 3%<br>Adults, Pediatrics, Infants, Neonates:<br>0% - 69% unspecified | Radical 7<br>Rad 87<br>Rad 57t |
| Accuracy - SpO2<br>Low Perfusion | Adults, Pediatrics, Infants, Neonates:<br>70% - 100% $\pm$ 2%<br>Adults, Pediatrics, Infants, Neonates:<br>0% - 69% unspecified | Radical 7<br>Rad 87<br>Rad 57t |
| Accuracy - Pulse Rate<br>During No Motion<br>Conditions | Adults, Pediatrics, Infants, Neonates:<br>25 - 240 $\pm$ 3 bpm | Radical 7<br>Rad 87<br>Rad 57t |
| Accuracy - Pulse Rate<br>During Motion Conditions | Adults, Pediatrics, Infants, Neonates:<br>25 - 240 $\pm$ 5 bpm | Radical 7<br>Rad 87<br>Rad 57t |
| Accuracy - Pulse Rate<br>Low Perfusion | Adults, Pediatrics, Infants, Neonates:<br>25 - 240 $\pm$ 3 bpm | Radical 7<br>Rad 87<br>Rad 57t |
| Accuracy: SpCO | See Footnote 1 | |
| Accuracy - SpCO<br>During No Motion<br>Conditions | Adults, Pediatrics, Infants: 1% -<br>40% $\pm$ 3% | Radical 7<br>Rad 87 |
| Accuracy: SpMet | See Footnote 1 | |
| Accuracy - SpMet<br>During No Motion<br>Conditions | Adults, Pediatrics, Infants, Neonates:<br>1% - 15% $\pm$ 1% | Radical 7<br>Rad 87 |
| FEATURES | SPECIFICATIONS | TYPE OF<br>PULSE CO-OXIMETER |
| Accuracy: SpHb | | |
| Accuracy - SpHb<br>During No Motion<br>Conditions | Adults, Pediatrics: 7 - 17 g/dl +1 g/dl<br>• SpHb accuracy has been validated<br>on healthy adult male and female<br>volunteers and on surgical patients<br>with light to dark skin pigmentation<br>in the range of 7 - 17 g/dl SpHb<br>against a laboratory CO-oximeter.<br>This variation equals plus or minus<br>one standard deviation which<br>encompasses 68% of the population.<br>The SpHb accuracy has not been<br>validated with motion or low<br>perfusion. | Radical 7<br>Rad 87<br>Rad 57t |
| General | | |
| Resolution | SpO2: 1%<br>Pulse Rate: 1 bpm<br>SpHb: 0.1 g/dl | Radical 7<br>Rad 87<br>Rad 57t |
| Resolution | SpCO: 1%<br>SpMet: 0.1% | Radical 7<br>Rad 87 |
| Measurements | Low Signal IQ<br>Perfusion Index (PI)<br>Total Oxygen Concentration (CaO2) | Radical 7<br>Rad 87<br>Rad 57t |
| Measurements | Pleth Variability Index (PVI) | Radical 7<br>Rad 87 |
| Interfering Substances | • Elevated levels of Methemoglobin<br>(MetHb) may lead to inaccurate<br>SpO2 and SpCO measurements<br>• Elevated levels of<br>Carboxyhemoglobin (COHb) may<br>lead to inaccurate SpO2<br>measurements.<br>• Very low arterial Oxygen Saturation<br>(SpO2) levels may cause inaccurate<br>SpCO and SpMet measurements<br>• Severe anemia may cause erroneous<br>SpO2 readings.<br>• Dyes, or any substance containing<br>dyes, that change usual blood<br>pigmentation may cause erroneous<br>readings.<br>• Elevated levels of total bilirubin<br>may lead to inaccurate SpO2,<br>SpMet, SpCO and SpHb readings | Radical 7<br>Rad 87<br>Rad 57t<br>(Notes regarding SpCO<br>and SpMet measurements<br>are not applicable to Rad<br>57t) |
| Electrical | See Footnotes 6 and 7 | |
| Power (AC) | Voltage Input Range: 100-230 Volt,<br>47-63 Hz | Radical 7<br>Rad 87 |
| Batteries | Rechargeable | Radical 7<br>Rad 87 |
| Batteries | Non-Rechargeable | Rad 57t |
| Circuitry | Microprocessor controlled | Radical 7 |
| FEATURES | SPECIFICATIONS | TYPE OF<br>PULSE CO-OXIMETER |
| | Automatic self-test of oximeter when<br>powered on | Rad 87 |
| | Automatic setting of default<br>parameters | Rad 57t |
| | Automatic alarm messages | |
| | Trend data output | |
| Firmware | Rainbow SET technology, MX-1<br>Board/Circuitry | Radical 7 |
| | | Rad 87 |
| | | Rad 57t |
| Mechanical | | |
| Material | Polycarbonate/ABS Blend | Radical 7 |
| | | Rad 87 |
| | | Rad 57t |
| Environmental | | |
| Operating Temperature | 41°F to + 104°F (5°C to +40°C) | Radical 7 |
| | | Rad 87 |
| | | Rad 57t |
| Storage Temperature | -40°F to + 158°F (-40°C to +70°C) | Radical 7 |
| | | Rad 87 |
| | | Rad 57t |
| Relative Humidity | 5% to 95% noncondensing | Radical 7 |
| | | Rad 87 |
| | | Rad 57t |
| Operating Altitude | Operating Altitude: 500 mbar to 1,060<br>mbar pressure; -1,000 ft to 18,000 ft (-<br>304 m to 5,486m) | Radical 7 |
| | | Rad 87 |
| | | Rad 57t |
| Mode & Sensitivity | | |
| Averaging Mode | General: 2, 4, 6, 8, 10, 12 and 16<br>seconds<br>• With FastSat the averaging time is<br>dependent on the input signal<br>• For the 2 and 4 second settings the<br>averaging time may range from 2-4<br>and 4-6 seconds respectively<br>• Maximum sensitivity mode fixes<br>perfusion limit to 0.02% | Radical 7 |
| | | Rad 87 |
| | | Rad 57t |
| Sensitivity | APOD | Radical 7 |
| | Normal | Rad 87 |
| | Maximum | Rad 57t |
| Alarms | | |
| Volume Level Adjustment:<br>Pulse/Tone | OFF<br>25% to 100% in 4 increments | Radical 7 |
| | | Rad 87 |
| Volume Level Adjustment:<br>Pulse/Tone | OFF<br>33% to 100% in 3 step | Rad 57t |
| Alarm Silence | 120 seconds delay<br>All mute: continuous silence | Radical 7 |
| | | Rad 87 |
| | | Rad 57t |
| Out of Limit Alarm:<br>SpO2, Pulse Rate, SpHb | High/low alarms | Radical 7 |
| | | Rad 87 |
| | | Rad 57t |
| FEATURES | SPECIFICATIONS | TYPE OF<br>PULSE CO-OXIMETER |
| Out of Limit Alarm:<br>SpCO, SpMet | High/ low alarms | Radical 7<br>Rad 87 |
| Sensor Condition Alarm | No Sensor<br>Sensor Off<br>Sensor Defect | Radical 7<br>Rad 87<br>Rad 57t |
| System | System failure | Radical 7<br>Rad 87<br>Rad 57t |
| Battery Alarm | Low battery | Radical 7<br>Rad 87<br>Rad 57t |
| Display and Indicators | | |
| Data Display | SpO2 (%)<br>Pulse rate (bpm)<br>SpHb (g/dl)<br>Perfusion index (%)<br>CaO2 (ml/dl)<br>Signal IQ<br>Sensitivity indicator<br>Sensor status<br>Status messages<br>Alarm status<br>Battery status | |
| | SpCO (%)<br>SpMet (%)<br>Pleth variability index (%) | Radical 7<br>Rad 87 |
| Output Interface | | |
| SatShare Port | SatShare connection to Multiparameter<br>monitors (SpO2 only) | Radical 7 |
| Analog output | Nurse Call | Radical 7<br>Rad 87 |
| Serial Port<br>(RS-232 connector) | PC/printer connetion<br>Philips Vuelink<br>RadNet<br>Patient Safety Net<br>Trends | Radical 7<br>Rad 87 |
| Sensor connector | Trends | Rad 57t |
| Compliance | | |
| EMC Compliance | EN 60601-1-2, Class B…
