Masimo Radical-7R User manual

Pulse CO- Oximeter
with Rainbow Technology
OPERATOR’S MANUAL

Radical-7R Pulse CO-Oximeter Operator’s Manual i
The Radical-7R Pulse CO-Oximeter Operating Instructions provide the necessary information for
proper operation of all models of the Radical-7R Pulse CO-Oximetry system. There may be information
provided in this manual that is not relevant for your system.
General knowledge of pulse oximetry and an understanding of the features and functions of the
Radical-7R Pulse CO-Oximeter are prerequisites for its proper use.
Do not operate the Radical-7R Pulse CO-Oximeter without completely reading and understanding the
instructions in this manual.
NOTICE:
Purchase or possession of this instrument does not carry any express or implied license to use this
instrument with replacement parts which would, alone or in combination with this instrument, fall within
the scope of one of the patents relating to this instrument.
CAUTION:
Federal law (U.S.) restricts this instrument to sale by or on the order of a physician.
Masimo Corporation
40 Parker
Irvine, CA 92618
USA
Tel.: [phone]
Fax.: [phone]
www.masimo.com
Covered by one or more of the following U.S. Patents: RE38,492, RE38,476, 7,221,971, 7,215,986,
7,215,984, 7,186,966, 6,979,812, 6,861,639, 6,850,787, 6,826,419, 6,816,741, 6,745,060, 6,699,194,
6,684,090, 6,654,624, 6,650,917, 6,643,530, 6,606,511, 6,515,273, 6,501,975, 6,463,311, 6,430,525,
6,388,240, 6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,157,850, 6,067,462, 6,011,986, 6,002,952,
5,919,134, 5,769,785, 5,758,644, 5,685,299, 5,632,272, 5,490,505, 5,482,036, international equivalents,
or one or more of the patents referenced at www.masimo.com/patents.htm. Products containing
SatShare®feature are also covered by U.S. Patent 6,770,028. Other patents pending.
© 2009 Masimo Corporation, Masimo, , RadNet, Rainbow, SpCO, SpMet, SpHb, Discrete Saturation
Transform, DST, DCI, FastSat, SatShare, PVI, SET, Signal IQ, LNOP and LNCS are federally registered
trademarks of Masimo Corporation.
Radical-7R, Patient SafetyNet, Radical Screen, LNOPv, APOD, SpOC, SpHct, Pulse CO-Oximeter, Pleth
Variability Index and RRa are trademarks of Masimo Corporation.

Radical-7R Pulse CO-Oximeter Operator’s Manual
NON-INVASIVE TOTAL HEMOGLOBIN (SpHb) ACCURACY COMPARED TO INVASIVE
LABORATORY METHODS*
In 492 comparisons of non-invasive total hemoglobin (SpHb) and invasive hemoglobin (tHb)
measurements from a laboratory CO-Oximeter, SpHb accuracy was as follows:
■ 0.90 correlation
■ 0.95 g/dL standard deviation
■ Below 12 g/dL, 99% of SpHb readings were < 2 g/dL of the laboratory tHb value
■ At or above 12 g/dL, 94% of SpHb readings were < 2 g/dL of the laboratory value
* Masimo FDA Submission Data
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES
The Radical-7R Signal Extraction Pulse CO-Oximeter is designed to minimize
the possibility of hazards from errors in the software program by following sound
engineering design processes, Risk Analysis and Software Validation.
■Variation in hemoglobin measurements may be profound and may be affected by
sample type, body positioning, as well as other physiological conditions. As with most
hemoglobin tests, Radical-7R test results should be scrutinized in light of a specific
patient’s condition. Any results exhibiting inconsistency with the patient’s clinical status
should be repeated and/or supplemented with additional test data.
■Explosion hazard. Do not use the Pulse CO-Oximeter in the presence of
flammable anesthetics or other flammable substance in combination with air,
oxygen-enriched environments, or nitrous oxide.
■High intensity, extreme lights (including pulsating strobe lights) directed on the sensor
may not allow the Pulse CO-Oximeter to obtain readings.
■Excessive ambient noise may affect the accuracy of the respiration rate reading from the
Acoustic Respiration Sensor.
■When monitoring Acoustic Respiration, Masimo recommends minimally monitoring
both oxygenation (SpO2) and respiration (RRa).
■The Pulse CO-Oximeter is NOT intended for use as an apnea monitor.
■Pulse rate measurement is based on the optical detection of a peripheral flow pulse
and therefore may not detect certain arrhythmias. The Pulse CO-Oximeter should
not be used as a replacement or substitute for ECG based arrhythmia analysis.
■The Pulse CO-Oximeter should be considered an early warning instrument. As a
trend towards patient hypoxemia is indicated, blood samples should be analyzed
by laboratory instruments to completely understand the patient’s condition.
■The Pulse CO-Oximeter is to be operated by qualified personnel only. This
manual, accessory Directions for Use (DFU), all precautionary information, and
specifications should be read before use.
■Electric shock hazard. Do not open the Pulse CO-Oximeter cover except to
replace the battery of the Handheld instrument. Only a qualified operator may
perform maintenance procedures specifically described in this manual. Refer
servicing to Masimo for repair of this equipment.
■ Ensure that the HF surgical neutral electrode is properly connected to help prevent unin-
tended current return paths when using high frequency (HF) surgical equipment.
■As with all medical equipment, carefully route patient cabling to reduce the
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Radical-7R Pulse CO-Oximeter Operator’s Manual
possibility of patient entanglement or strangulation.
■ Use cables only from the instrument manufacturer to provide protection against the
effects of discharge from a cardiac defibrillator and burns.
■ Do not place the Pulse CO-Oximeter or accessories in any position that might cause it to
fall on the patient. Do not lift the Pulse CO-Oximeter by the power cord or any other cable.
■Interfering Substances: Dyes, or any substance containing dyes, that change usual
blood pigmentation may cause erroneous readings.
■SpO2is empirically calibrated to functional arterial oxygen saturation in healthy adult
volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin
(MetHb). A Pulse CO-Oximeter can not measure elevated levels of COHb or MetHb.
Increases in either COHb or MetHb will affect the accuracy of the SpO2measurement.
■ For increased COHb: COHb levels above normal tend to increase the level of SpO2.
The level of increase is approximately equal to the amount of COHb that is present.
NOTE: High levels of COHb may occur with a seemingly normal SpO2. When
elevated levels of COHb are suspected, laboratory analysis (CO-Oximetry) of a
blood sample should be performed.
■For increased MetHb: the SpO2may be decreased by levels of MetHb of up
to approximately 10% to 15%. At higher levels of MetHb, the SpO2may tend
to read in the low to mid 80s. When elevated levels of MetHb are suspected,
laboratory analysis (CO-Oximetry) of a blood sample should be performed.
■Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO2and
SpCO measurements.
■
Elevated levels of Carboxyhemoglobin (COHb) will lead to inaccurate SpO2measurements.
■Elevated levels of Total Bilirubin may lead to inaccurate SpO2, SpMet, SpCO,
SpHb, SpOC and SpHct measurements.
■
Motion artifact may lead to inaccurate SpMet, SpCO, SpHb, SpOC and SpHct measurements.
■Very low arterial Oxygen Saturation (SpO2) levels may cause inaccurate SpCO
and SpMet measurements.
■Severe anemia may cause erroneous SpO2readings.
■
Hemoglobin synthesis disorders may cause erroneous SpHb, SpOC and SpHct readings.
■Do not use the Pulse CO-Oximeter or sensors during magnetic resonance
imaging (MRI) scanning. Induced current could potentially cause burns. The Pulse
CO-Oximeter may affect the MRI image, and the MRI instrument may affect the
accuracy of the Pulse CO-Oximetry parameters and measurements.
■
If using Pulse CO-Oximetry during full body irradiation, keep the sensor out of the
radiation field. If the sensor is exposed to the radiation, the reading might be inaccurate
or the instrument might read zero for the duration of the active radiation period.
■For home use, ensure that the Pulse CO-Oximeter’s alarm can be heard from
other rooms in the house, especially when noisy appliances such as vacuum
cleaners, dishwashers, clothes dryers, televisions, or radios are operating.
■Always remove the sensor from the patient and completely disconnect the patient
from the Pulse CO-Oximeter before bathing the patient.
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED)
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Radical-7R Pulse CO-Oximeter Operator’s Manual
SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED)
iv
■Additional information specific to Masimo sensors, including information about parameter/
measurement performance during motion and low perfusion, may be found in the sensor's
Directions for Use (DFU).
■
Do not place the Pulse CO-Oximeter where the controls can be changed by the patient.
■Do not place the Pulse CO-Oximeter on electrical equipment that may affect the Pulse
CO-Oximeter, preventing it from working properly.
■Do not expose the Pulse CO-Oximeter to excessive moisture such as direct exposure to rain.
Excessive moisture can cause the Pulse CO-Oximeter to perform inaccurately or fail.
■Do not place containers with liquids on or near the Pulse CO-Oximeter. Liquids spilled on the
Pulse CO-Oximeter may cause it to perform inaccurately or fail.
■
If the Pulse CO-Oximeter fails any part of the setup procedures or leakage tests, remove the
Pulse CO-Oximeter from operation until qualified service personnel have corrected the situation.
■Patient Safety - If a sensor is damaged in any way, discontinue use immediately.
■
Disposal of product - Comply with local laws in the disposal of the instrument and/or its accessories.
■The Pulse CO-Oximeter can be used during defibrillation, but the readings may be
inaccurate for up to 20 seconds.
■This equipment has been tested and found to comply with the limits for medical instruments
to the EN 60601-1-2: 2002, Medical Instrument Directive 93/42/EEC. These limits are
designed to provide reasonable protection against harmful interference in a typical medical
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 other instruments in the vicinity. However, there is no guarantee that interference will not
occur in a particular installation. If this equipment does cause harmful interference to other
instruments, 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 instrument.
■Increase the separation between the equipment.
■Connect the equipment into an outlet on a circuit different from that to which the other
instrument(s) are connected.
■ Consult the manufacturer for help. To ensure safety, avoid stacking multiple instruments or
placing anything on the instrument during operation.
■ Ensure the speaker is not covered or the instrument is placed face-down on bedding or other
sound absorbing surface.
■To protect against injury from electric shock, follow the directions below:
■ Do not place the instrument near water.
■Avoid placing the instrument on surfaces with visible liquid spills.
■Do not soak or immerse the instrument in liquids.
■Always turn off and disconnect the power cord from the AC power supply before cleaning
the instrument.
■Use cleaning solutions sparingly.

Radical-7R Pulse CO-Oximeter Operator’s Manual
SECTION 1 - OVERVIEW
About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Warnings, Cautions and Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Pulse CO-Oximetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
SpO2General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
SpCO General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
SpMet General Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
SpHb General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Total Arterial Oxygen Content (CaO2) General Description . . . . . . . . . . . . . . . . . . . . 1-5
Rainbow Acoustic Monitoring General Description. . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
SpOC General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
SpHct General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Principle of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Functional Saturation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Radical-7R vs. Drawn Whole Blood Measurements . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Signal Extraction Technology (SET) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
SpCO, SpMet and SpHb Measurements During Patient Motion . . . . . . . . . . . . . . . 1-8
Rainbow Acoustic Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Masimo Rainbow SET Parallel Engines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Masimo SET DST®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
SECTION 2 - SYSTEM DESCRIPTION
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Radical-7R Pulse CO-Oximeter Handheld. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Handheld Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Handheld Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Radical-7R Pulse CO-Oximeter Standalone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Standalone Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Standalone Back Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
Radical-7R Monitor Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
SECTION 3 - SETUP
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Unpacking and Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Preparation for Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Radical-7R Docking Station Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Initial Battery Charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Initial Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Factory Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
SatShare Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
SECTION 4 - OPERATION
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Basic Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
General Setup and Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
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Radical-7R Pulse CO-Oximeter Operator’s Manual
Successful Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Masimo Pulse CO-Oximetry Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Numeric Display - SpO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Numeric Display - Pulse Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Numeric Display - RRa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Numeric Display - SpCO. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Numeric Display - SpMet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Numeric Display - SpHb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Numeric Display - SpOC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Numeric Display - SpHct. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Signal Indication and Quality Indicator (SIQ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Signal Indication and Quality Indicator (SIQa) . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Respiration Indicator (RI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Acoustic Respiration Sensor Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Numeric Display - (PI). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Pleth Variability Index - (PVI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Low Perfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Actions To Be Taken . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Touch Key Control Button and Icons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Traditional User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Navigating the Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Main Menu Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Menu Categories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Editing a Parameter/Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Menu Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
About . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
Satshare Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
SECTION 5 - ALARMS AND MESSAGES
Alarm Identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
System Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
SECTION 6 - TROUBLESHOOTING
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
SECTION 7 - SPECIFICATIONS
Radical-7R Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Analog Output/Nurse Call Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Nurse Call . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
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Radical-7R Pulse CO-Oximeter Operator’s Manual
SECTION 8 - SENSORS & PATIENT CABLES
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Selecting a Masimo SET Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Sensor Application Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Masimo Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Masimo Acoustic Respiration Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Masimo Rainbow Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Rainbow Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Rainbow ReSposable Pulse CO-Oximeter Sensor System . . . . . . . . . . . . . . . . . . . 8-2
Rainbow Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Rainbow Direct Connect Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Masimo SpO2Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
ReSposable Pulse CO-Oximeter Sensor System. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Red Direct Connect Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
LNOP®Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
LNOP®Adhesive Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
LNOPvTM Adhesive Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4
LNOP®Specialty Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
M-LNCS™/LNCS®Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
M-LNCS™/LNCS®Adhesive Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
M-LNCS™/LNCS®Specialty Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Sensor Accuracy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Cleaning And Reuse Of Masimo Reusable Sensors and Cables. . . . . . . . . . . . . . . 8-6
Reattachment of a Single Use Acoustic Respiration Sensor . . . . . . . . . . . . . . . . . . 8-6
Reattachment of Single Use Adhesive Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
SECTION 9 - SERVICE AND MAINTENANCE
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Battery Operation and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Replacing the Batteries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Replacing the Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Performance Verification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Service and Repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Repair Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Return Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Sales & End-User License Agreement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Exclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
End-User License Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
Restrictions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
No Implied License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
Sensors Licensed for Monitoring Use Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
SECTION 10 - PART NUMBERS
Part Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Table of Contents
vii

Radical-7R Pulse CO-Oximeter Operator’s Manual 1-1
1
Overview
About This Manual
This manual explains how to set up and use the Radical-7R Pulse CO-Oximeter containing
Masimo Rainbow SET®technology. Important safety information relating to general use of
the Pulse CO-Oximeter appears before this introduction. Other important safety information
is located throughout the manual where appropriate.
Read the entire safety information section before you operate the monitor.
In addition to the safety section, this manual includes the following sections:
SECTION 1
OVERVIEW gives a general description of Radical-7R Pulse
CO-Oximeter.
SECTION 2 SYSTEM DESCRIPTION describes the Radical-7R Pulse
CO-Oximeter system and its functions and features.
SECTION 3
SETUP describes how to setup the Radical-7R Pulse CO-Oximeter for
use
.
SECTION 4 OPERATION describes the operation of the Radical-7R Pulse
CO-Oximetry system.
SECTION 5 ALARMS AND MESSAGES describes the alarm system messages.
SECTION 6 TROUBLESHOOTING describes troubleshooting information.
SECTION 7 SPECIFICATIONS gives the detailed specifications of the Radical-7R
Pulse CO-Oximeter.
SECTION 8 SENSORS & PATIENT CABLES outlines how to use and care for
Masimo Rainbow SET technology sensors, Masimo Rainbow SET
technology patient cables, Masimo Red sensors and Masimo Red
patient cables.
SECTION 9 SERVICE AND MAINTENANCE describes how to maintain, service
and obtain repair for the Radical-7R Pulse CO-Oximeter.
SECTION 10
PART NUMBERS lists the available Radical-7R Pulse CO-Oximeter
accessories.

1-2 Radical-7R Pulse CO-Oximeter Operator’s Manual
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Warnings, Cautions and Notes
Please read and follow any warnings, cautions and notes presented throughout this
manual. An explanation of these labels are as follows:
A WARNING is provided when actions may result in a serious outcome (i.e., injury,
serious adverse affect, death) to the patient or user. Look for text in a gray shaded box.
Sample of Warning:
WARNING: THIS IS A SAMPLE OF A WARNING STATEMENT.
A CAUTION is given when any special care is to be exercised by the patient or user to avoid
injury to the patient, damage to this instrument or damage to other property.
Sample of Caution:
CAUTION: THIS IS A SAMPLE OF A CAUTION STATEMENT.
A NOTE is provided when extra general information is applicable.
Sample of Note:
NOTE: This is a sample of a Note.
Overview

Radical-7R Pulse CO-Oximeter Operator’s Manual 1-3
1
Overview
Product Description
The Radical-7R Pulse CO-Oximeter is a noninvasive, arterial oxygen saturation, total
hemoglobin concentration and pulse rate monitor. It can be used as either a Handheld or
a Standalone monitor. The Radical-7R Pulse CO-Oximeter features a backlit Liquid Crystal
Display (LCD) that continuously displays numeric values for SpO2, SpMet®*, SpCO®*,
SpHb®*, SpOC™*, SpHct™, respiration rate (RRa™), pulse rate, Perfusion Index (PI)
and Pleth Variability Index (PVI®). It also provides graphical displays for plethysmographic
waveform and Signal Identification and Quality Indicator (Signal IQ®). The Radical-7R Pulse
CO-Oximeter can be used to interface with a multiparameter patient monitor to provide Masimo
SET SpO2and pulse rate information to that monitor for display.
FEATURES
These features are common to the Radical-7R family:
■Masimo SET is clinically proven to be the highest sensitivity and specificity pulse
oximeter technology in the world.
■Rainbow technology uses 7+ wavelengths of light to continuously and noninvasively
measure carboxyhemoglobin (SpCO), methemoglobin (SpMet) and total hemoglobin
(SpHb), as well as providing a more reliable probe-off detection.
■
Rainbow Acoustic Monitoring uses acoustic monitoring technology to measure and display
respiration rate (RRa) while providing the Respiration Indicator (RI) at the sensor site.
■ SIQa displays the confidence level of the Acoustic Respiration measurement signal quality.
■Total Oxygen Content (SpOC™*) provides a calculated measurement of the amount
of oxygen in arterial blood, which may provide useful information about oxygen both
dissolved in plasma and combined with hemoglobin.
■Displays percent hematocrit (%SpHct), the measurement of total red blood cell count
divided by total blood volume.
■Perfusion Index (PI) with trending capability indicates arterial pulse signal strength and
may be used as a diagnostic tool during low perfusion.
■*Pleth Variability Index (PVI) may show changes that reflect physiologic factors such as
vascular tone, circulating blood volume, and intrathoracic pressure excursions.1
■Accurate on cyanotic infants with congenital heart disease when used with an LNOP®
Blue Sensor.
■Signal IQ waveform for signal identification and quality indication during excessive
motion and low signal to noise situations.
■
FastSat®tracks rapid changes in arterial O2with high fidelity unlike any other pulse oximeter.
■SatShare® interface allows transfer of SpO2 and pulse rate to an existing multiparameter
monitor and allows for the reading of SpCO, SpMet, SpHb and SpOC on adjacent Radical-
7R monitor.
■Detachable portable handheld for patient transport.
1The utility of PVI is unknown at this time and requires further clinical studies. Technical factors that may
affect PVI include probe malposition and patient motion.
* Optional parameters/measurements

1-4 Radical-7R Pulse CO-Oximeter Operator’s Manual
1Overview
INDICATIONS FOR USE
The Radical-7R Pulse CO-Oximeter and accessories are indicated for the continuous
noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2),
pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total
hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Radical-7R 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 hospitals, hospital-type facilities, mobile, and home environments. In addition, the Radical-
7R Pulse CO-Oximeter and accessories are indicated to provide the continuous noninvasive
monitoring data obtained from the Radical-7R Pulse CO-Oximeter and accessories of
functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter
devices for the display of those devices.
Pulse CO-Oximetry
SpO2GENERAL DESCRIPTION
Pulse CO-Oximetry is a continuous and noninvasive 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 is connected to the Pulse
CO-Oximetry instrument with a patient cable. The sensor collects signal data from the patient
and sends it to the instrument. The instrument displays the calculated data in three ways:
1. As a percent value for arterial oxygen saturation (SpO2)
2. As a pulse rate (PR)
3. As a plethysmographic waveform
The following figure shows the general monitoring setup.
SpHb g/dl
17
7
10.0
13
SpOC ml/dl
---
---
---
---
3.00
6
20
a
a
SpCO GENERAL DESCRIPTION
Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of carbon
monoxide 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 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 SpCO, which reflect
blood levels of carbon monoxide bound to hemoglobin.
SpMet GENERAL DESCRIPTION
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
1. Instrument
2. Patient Cable
3. Sensor

Radical-7R Pulse CO-Oximeter Operator’s Manual 1-5
1
Overview
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.
SpHb GENERAL DESCRIPTION
Pulse CO-Oximetery is a continuous and non-invasive method of measuring the levels of total
hemoglobin (SpHb) in arterial blood. It relies on the same principles of pulse oximetry to make the
SpHb measurement.The measurement is taken by a sensor capable of measuring SpHb, usually on
the fingertip for adult and pediatric patients.The sensor connects directly to the Pulse CO-Oximeter
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 measurement of total hemoglobin concentration.
TOTAL ARTERIAL OXYGEN CONTENT (CaO2) GENERAL DESCRIPTION 2
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 HbO2is the fractional arterial oxygen saturation and PaO2is the partial pressure
of arterial oxygen.
For typical PaO2values, 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
2Martin, Laurence. All You Really Need to Know to Interpret Arterial Blood Gases, Second
Edition. New York: Lippincott Williams & Wilkins, 1999.
RAINBOW ACOUSTIC MONITORING GENERAL DESCRIPTION
Rainbow Acoustic Monitoring continuously measures a patient's respiration rate based on
airflow sounds generated in the upper airway. The Acoustic Respiration 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.
SpOC GENERAL DESCRIPTION (PULSE CO-OXIMETRY)
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.
SpHct GENERAL DESCRIPTION
Hematocrit is the fraction of whole blood volume that consists of red blood cells. In nor-
mal conditions, there is a linear relationship between hematocrit and the concentration
of hemoglobin. An estimated hematocrit as a percentage may be derived by multiplying

1-6 Radical-7R Pulse CO-Oximeter Operator’s Manual
1Overview
1
the hemoglobin concentration in g/dL times three and dropping the units1,2. The hematocrit
measurement is determined mathematically in this monitor as:
%Hct = Hb* g/dL x 2.953
* When Hb concentrations are between 8-17 g/dL.
1Nijboer JMM, van der Horst ICC, Hendriks HGD, Hendrik-Jan ten Duis; Mijsten MWN. Myth or Reality:
Hematocrit and Hemoglobin Differ in Trauma. Journal of TRAUMA Injury, Infection, and Critical Care 2007;
62:1310-1312
2 MS, Weatherall; KM Sherry. An evaluation of the Spuncrit infr-red analyzer for measurement of Haema-
tocrit: Clin. Lab. Haem. 1997, 19, 183-186
PRINCIPLE OF OPERATION
1. Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood),
carboxyhemoglobin (blood with carbon monoxide content), methemoglobin (blood with oxidized
hemoglobin) and blood plasma constituents differ in their absorption of visible and infrared light
(using spectrophotometry)
.
Carboxyhemoglobin
Oxyhemoglobin
Methemoglobin
Deoxyhemoglobin
Absorption Spectra
Plasma
Absorption (1/mm)
0
0.5
600 800
1.0
1.5
2.0
2.5
3.0
3.5
4.0
1000 1200 1400 1600
Wavelength (nm)
2. The amount of arterial blood in tissue changes with your pulse (photoplethysmography). Therefore,
the amount of light absorbed by the varying quantities of arterial blood changes as well.
The Radical-7R Pulse CO-Oximeter uses a multi-wavelength sensor to distinguish between oxygenated
blood, deoxygenated blood, blood with carbon monoxide, oxidized blood and blood plasma. The Radical-
7R 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-7R for calculation
.
Once the Radical-7R receives the signal from the sensor, it utilizes Masimo Rainbow SET
signal extraction technology 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 (BPM)). The SpCO, SpMet and
1. Light Emitting Diodes (LEDs)
(7 + wavelengths)
2. Detector
2
1

Radical-7R Pulse CO-Oximeter Operator’s Manual 1-7
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1
Overview
SpHb measurements rely on a multiwavelength 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.
FUNCTIONAL SATURATION
The Radical-7R is calibrated to measure and display functional saturation (SpO2): the amount
of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport
oxygen. Note that carboxyhemoglobin is not capable of transporting oxygen, but is recognized
as oxygenated hemoglobin by conventional pulse oximetry.
Radical-7R vs. DRAWN WHOLE BLOOD MEASUREMENTS
When SpO2, SpCO, SpMet and SpHb measurements obtained from the Radical-7R (non-
invasive) are compared to drawn whole blood (invasive) measurements by blood gas and/or
laboratory CO-Oximetry methods, caution should be taken when evaluating and interpreting the
results.The blood gas and/or laboratory CO-Oximetry measurements may differ from the SpO2,
SpCO, SpMet, SpHb, SpOC, and SpHct measurements of the Radical-7R Pulse CO-Oximeter.
In the case of SpO2, different results are usually obtained from the arterial blood gas sample if
the calculated measurement is not appropriately corrected for the effects of variables that shift
the relationship between the partial pressure of oxygen (PO2) and saturation, such as: pH,
temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal hemoglobin.
In the case of SpCO, different results are also expected if concentration of methemoglobin in
the blood gas sample is abnormal (greater than 2% for methemoglobin concentration). High
levels of bilirubin may cause erroneous SpO2, SpMet, SpCO and SpHb readings. As blood
samples are usually taken over a period of 20 seconds (the time it takes to draw the blood)
a meaningful comparison can only be achieved if the oxygen saturation, carboxyhemoglobin
and methemoglobin concentration of the patient are stable and not changing over the period of
time that the blood gas sample is taken. Subsequently, blood gas and laboratory CO-Oximetry
measurements of SpO2, SpCO, SpMet, SpHb, SpOC and SpHct may vary with the rapid
administration of fluids and in procedures such as dialysis. Additionally, drawn, whole-blood
testing can be affected by sample handling methods and time elapsed between blood draw
and sample testing.
SIGNAL EXTRACTION TECHNOLOGY (SET)
Masimo Signal Extraction Technology's signal processing differs from that of conventional
pulse oximeters. Conventional pulse oximeters assume that arterial blood is the only blood
moving (pulsating) in the measurement site. During patient motion, however, the venous blood
also moves, causing conventional pulse oximeters to read low values, because they cannot
distinguish between the arterial and venous blood movement (sometimes referred to as noise).
Masimo SET pulse oximetry utilizes parallel engines and adaptive digital filtering. Adaptive
filters are powerful
because they are able to adapt to the varying physiologic signals and/or
noise and separate them by looking at the whole signal and breaking it down to its fundamental
components. The Masimo SET signal processing algorithm, Discrete Saturation Transform®
(DST®), in parallel with Fast Saturation Transform® (FST®), reliably identifies the noise, isolates
it and, using adaptive filters, cancels it. It then reports the true arterial oxygen saturation for display
on the monitor.

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SPCO, SPMET, AND SPHB MEASUREMENTS DURING PATIENT MOTION
The Radical-7R 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.The measurements for SpCO, SpMet and SpHb display “---” 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
Rainbow Acoustic Monitoring is a real time, continuous, non-invasive method for measuring
respiration rate based on respiratory sounds. 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
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 Acquisiton
System
Signal
Processing
Respiratory
Airflow to
Sound
Sound to
Electrical
Signal
Electrical
Signal to
Digital Signal
Digital Signal
to Respiratory
Measurement
Envelope Detection RRa Estimation
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 contrib-
ute 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 and transmits respiratory sounds (and other biological sounds) much
like a microphone does. When subjected to a mechanical strain, (i.e., surface vibrations
generated during breathing), the sensor becomes electrically polarized. The degree of
polarization is proportional to the applied strain. This is known as the ‘Piezoelectric effect’ in
this manual. 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.
Overview

Radical-7R Pulse CO-Oximeter Operator’s Manual 1-9
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Overview
Acquisition System
The acquisition system converts the electrical signal provided by the sensor into a digital
signal. This format allows the signal to be processed by a computing device.
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 figure on the previous
page, this can be performed by, for example, determining the digital signal envelope or out-
line 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 gases 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 bio-
medical 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.

1-10 Radical-7R Pulse CO-Oximeter Operator’s Manual
1
MASIMO SET DST®
Overview
MASIMO RAINBOW SET PARALLEL ENGINES
This figure is for conceptual purposes only.
SpOC
12
FST
MST

Radical-7R Pulse CO-Oximeter Operator’s Manual 2-1
2
System Description
Introduction
The Radical-7R provides the functionality of three instruments in one:
■The Radical-7R is a fully featured Handheld Pulse CO-Oximeter.
■The Radical-7R is a fully featured Standalone Pulse CO-Oximeter.
■The Radical-7R interfaces to the SpO2 input module of multiparameter patient
monitors to upgrade conventional pulse oximetry technology to Masimo SET
technology.
a
a
The Handheld portion of the Radical-7R contains the
majority of the Pulse CO-Oximeter features. All pulse co-
oximetry measurement information, as well as instrument
status data is displayed on the Handheld LCD screen.
All user input is performed through the control buttons
on the front panel.The sensor cable connector is located
on the Radical-7R Handheld Pulse CO-Oximeter.
The Handheld Pulse CO-Oximeter snaps into the Radical
Docking Station to provide a fully featured standalone
Pulse CO-Oximeter. The Docking Station connects
to AC power for standalone operation or charging of
the Handheld. An optional Docking Station battery is
available. The standalone Radical-7R features nurse
call, analog output and interfaces to serial printers.
97
76
SpHbg/dl
17
7
10.0
SpOC
Utilizing a SatShare®cable, the standalone Radical-
7R also interfaces with the SpO2 input of a validated
multiparameter patient monitor, instantly upgrading the
conventional pulse CO-oximetry to Masimo SET pulse
oximetry. The SatShare cable attaches to the back of the
Radical Docking Station, and SatShare cables are available
to interface with most multiparameter patient monitors
.
CAUTION:
■THE WAVEFORM DISPLAYED ON THE MULTIPARAMETER PATIENT
MONITOR IS A SIMULATED SIGNAL (NON-NORMALIZED). REFER TO THE
RADICAL-7R PULSE CO-OXIMETER DISPLAY FOR PATIENT WAVEFORM.
■IF DISPLAYING THE SIMULATED WAVEFORM IS NOT DESIRABLE, IT IS
RECOMMENDED TO TURN OFF THE PLETHYSMOGRAPHIC WAVEFORM
DISPLAY ON THE MULTIPARAMETER MONITOR.
■ONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED.
■ ONLY SpO2AND PULSE RATE CAN BE DISPLAYED ON THE
MULTIPARAMETER MONITOR WITH SATSHARE.

2-2 Radical-7R Pulse CO-Oximeter Operator’s Manual
2System Description
Radical-7R Pulse CO-Oximeter
Handheld
The Handheld Radical-7R Pulse CO-Oximeter provides most of the functionality of the
Pulse CO-Oximeter. All user input and displays are controlled by this part of the Radical-7R
Pulse CO-Oximeter system. The patient cable connects into the connector on the Handheld
instrument. The Handheld is battery powered and can be used either as a transport monitor or
as a Handheld Pulse CO-Oximeter for spot checks.
HANDHELD FRONT PANEL
The following figure and corresponding text outline all the features of the Handheld Radical-7R
Pulse CO-Oximeter:
Pleth + Signal IQ View
SpHb g/dl
17
7
14
13
---
--- --- ---
SpOC ml/dl
96
a
30 29 28
SpHb g/dl
17
7
14
13
---
--- --- ---
SpOC ml/dl
96
a
RI SIQa
3
32
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a