Masimo RAD7CPL User Manual

Pulse CO-

with Rainbow Technology

OPERATOR’S MANUAL

Oximeter

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.: 949-297-7000

Fax.: 949-297-7001

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.

Radical-7R, Patient SafetyNet, Radical Screen, LNOPv, APOD, SpOC, SpHct, Pulse CO-Oximeter, Pleth Variability Index and RRa are trademarks of Masimo Corporation.

, RadNet, Rainbow, SpCO, SpMet, SpHb, Discrete Saturation

Radical-7R Pulse CO-Oximeter Operator’s Manual i

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

ﬂ ammable anesthetics or other ﬂ ammable 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 qualiﬁ ed personnel only. This

manual, accessory Directions for Use (DFU), all precautionary information, and speciﬁ cations 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 qualiﬁ ed operator may perform maintenance procedures speciﬁ cally 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 unintended current return paths when using high frequency (HF) surgical equipment.

■ As with all medical equipment, carefully route patient cabling to reduce the

Radical-7R Pulse CO-Oximeter Operator’s Manual

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED)

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.

■ SpO

is 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 SpO

■

For increased COHb: COHb levels above normal tend to increase the level of SpO2.

measurement.

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 SpO

to approximately 10% to 15%. At higher levels of MetHb, the SpO to read in the low to mid 80s. When elevated levels of MetHb are suspected,

may be decreased by levels of MetHb of up

may tend

laboratory analysis (CO-Oximetry) of a blood sample should be performed.

■ Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO

SpCO measurements.

■

Elevated levels of Carboxyhemoglobin (COHb) will lead to inaccurate SpO2 measurements.

and

■ 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 SpO

■

Hemoglobin synthesis disorders may cause erroneous SpHb, SpOC and SpHct readings.

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 ﬁ eld. 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.

Radical-7R Pulse CO-Oximeter Operator’s Manual

iii

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED)

■ Additional information speciﬁ c 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 qualiﬁ ed 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 deﬁ brillation, 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

Table of Contents

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

SpO2 General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

SpCO General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

SpMet General Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

SpHb General Description Total Arterial Oxygen Content (CaO

Rainbow Acoustic Monitoring General Description. . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

) General Description . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10

1-5 1-5 1-5

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

Radical-7R Pulse CO-Oximeter Operator’s Manual

Table of Contents

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

Radical-7R Pulse CO-Oximeter Operator’s Manual

Table of Contents

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 SpO2 Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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

Radical-7R Pulse CO-Oximeter Operator’s Manual

vii

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

SECTION 2 SYSTEM DESCRIPTION describes the Radical-7R Pulse

SECTION 3

SECTION 4 OPERATION describes the operation of the Radical-7R Pulse

SECTION 5 ALARMS AND MESSAGES describes the alarm system messages.

SECTION 6 TROUBLESHOOTING describes troubleshooting infor mation.

SECTION 7 SPECIFICATIONS gives the detailed speciﬁ cations of the Radical-7R

SECTION 8 SENSORS & PATIENT CABLES outlines how to use and care for

SECTION 9 SERVICE AND MAINTENANCE describes how to maintain, service

SECTION 10

OVERVIEW gives a general description of Radical-7R Pulse

CO-Oximeter.

CO-Oximeter system and its functions and features.

SETUP describes how to setup the Radical-7R Pulse CO-Oximeter for

use

CO-Oximetry system.

Pulse CO-Oximeter.

Masimo Rainbow SET technology sensors, Masimo Rainbow SET technology patient cables, Masimo Red sensors and Masimo Red

patient cables.

and obtain repair for the Radical-7R Pulse CO-Oximeter.

PART NUMBERS lists the available Radical-7R Pulse CO-Oximeter

accessories.

Radical-7R Pulse CO-Oximeter Operator’s Manual 1-1

Overview

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.

1-2 Radical-7R Pulse CO-Oximeter Operator’s Manual

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 Identiﬁ cation 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 SpO2 and pulse rate

FEATURES

These features are common to the Radical-7R family:

■ Masimo SET is clinically proven to be the highest sensitivity and speciﬁ city pulse

oximeter

technology in the world.

■ Rainbow technology uses 7+ wavelengths of light to continuously and noninvasively

measure carboxyhemoglobin (SpCO), methemoglobin (SpMet) (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 reﬂ ect physiologic factors such as

vascular tone, circulating blood volume, and intrathoracic pressure excursions.

■ Accurate on cyanotic infants with congenital heart disease when used with an LNOP®

Blue Sensor.

■ Signal IQ waveform for signal identiﬁ cation and quality indication during excessive

motion and low signal to noise situations.

FastSat® tracks rapid changes in arterial O2 with high ﬁ delity 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 Radical7R monitor.

■ Detachable portable handheld for patient transport.

The 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

information to that monitor for display.

and total hemoglobin

Radical-7R Pulse CO-Oximeter Operator’s Manual 1-3

Overview

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 COOximeter 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 Radical7R 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

SpO

GENERAL 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 ﬁ nger tip 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 ﬁ gure shows the general monitoring setup.

17 7

10.0

SpHb g/dl

---

ml/dl

SpOC

---

3.00

1. Instrument

2. Patient Cable

3. Sensor

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 ﬁ ngertip 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 reﬂ ect

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

1-4 Radical-7R Pulse CO-Oximeter Operator’s Manual

Overview

of pulse oximetry (spectrophotometry) to make its SpMet measurement. The measurement is obtained by placing a sensor on a patient, usually on the ﬁ ngertip 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

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.

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 normal conditions, there is a linear relationship between hematocrit and the concentration of hemoglobin. An estimated hematocrit as a percentage may be derived by multiplying

Radical-7R Pulse CO-Oximeter Operator’s Manual 1-5

Overview

the hemoglobin concentration in g/dL times three and dropping the units

1,2

. 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.

Nijboer 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

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)

4.0

3.5

3.0

2.5

2.0

1.5

Absorption (1/mm)

1.0

0.5

0 600 800

Absorption Spectra

Carboxyhemoglobin

Oxyhemoglobin

Methemoglobin

Deoxyhemoglobin

Plasma

1000 1200 1400 1600

Wavelength (nm)

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 Radical7R 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 ﬁ ngertip, 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

1. Light Emitting Diodes (LEDs)

(7 + wavelengths)

2. Detector

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

1-6 Radical-7R Pulse CO-Oximeter Operator’s Manual

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), veriﬁ ed 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 (noninvasive) 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 ﬁ ltering. Adaptive ﬁ lters are powerful 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 identiﬁ es the noise, isolates it and, using adaptive ﬁ lters, cancels it. It then reports the true arterial oxygen saturation for display on the monitor.

Radical-7R Pulse CO-Oximeter Operator’s Manual 1-7

because they are able to adapt to the varying physiologic signals and/or

Overview

SPCO, SPMET, AND SPHB

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 aler t 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.

MEASUREMENTS DURING

PATIENT

MOTION

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

Respiratory Airflow to Sound

Sound to Electrical Signal

Acquisiton System

Electrical Signal to Digital Signal

Signal Processing

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 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 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.

1-8 Radical-7R Pulse CO-Oximeter Operator’s Manual

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 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 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 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.

Radical-7R Pulse CO-Oximeter Operator’s Manual 1-9

Overview

MASIMO RAINBOW SET PARALLEL ENGINES

This ﬁ gure is for conceptual purposes only.

FST

MST

SpOC

MASIMO SET DST

1-10 Radical-7R Pulse CO-Oximeter Operator’s Manual

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 oximetr y technology to Masimo SET

technology.

The Handheld portion of the Radical-7R contains the majority of the Pulse CO-Oximeter features. All pulse cooximetry 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

1 7

10.0

7 S p H b g / d

p O C

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.

Utilizing a SatShare® cable, the standalone Radical7R 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 SpO

AND PULSE RATE CAN BE DISPLAYED ON THE

MULTIPARAMETER MONITOR WITH SATSHARE.

Radical-7R Pulse CO-Oximeter Operator’s Manual 2-1

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System 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 batter y 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

---

SpOC ml/dl

RI SIQa

---

SpHb g/dl

---

SpOC ml/dl

2-2 Radical-7R Pulse CO-Oximeter Operator’s Manual

System Description

HANDHELD FRONT PANEL (CONTINUED)

RELEASE BUTTON

HANDHELD

SpO2 MEASUREMENT DISPLAY

SATURATION

__ 90

ALARM LIMITS DISPLAY

ALARM

STATUS INDICATOR

3.0

SpMet MEASUREMENT DISPLAY

SpMet ALARM LIMITS DISPLAY

5.6

SYSTEM

Sensor Off

MESSAGE AREA

SpCO

MEASUREMENT DISPLAY

SpCO ALARM LIMITS DISPLAY

SpHb

14.0

MEASUREMENT DISPLAY

Press down the Handheld Release Button and pull the Handheld instrument off the Docking Station.

The functional arterial hemoglobin oxygen saturation is displayed in units of percentage SpO2. The upper and lower SpO2 alarm limits are also displayed next to the SpO2 measurement. When a sensor is not connected to a patient and during pulse search, the display will show dashed lines and the message "Sensor Off" will appear at the top of the display screen. When the measured value is outside of the alarm limits, the SpO2 measurement display flashes and an alarm will sound. The oxygen saturation is calculated and the display is updated at a frequency of once per second.

The Saturation Alarm Limits Display shows the upper and lower saturation alarm limits. When an alarm limit is exceeded, the SpO2 value and the violated limit flashes.

The alarm status indicator (a bell) can be shown with or without a slash. It flashes when an alarm condition is present.

The measurement of methemoglobin concentration levels is displayed in units of percentage SpMet. The upper and lower SpMet alarm limits are also displayed next to the SpMet measurement. When a sensor is not connected to a patient and during pulse search, the display will show dashed lines and the message "Sensor Off" will appear at the top of the display screen. The methemoglobin is calculated and the display is updated at a frequency of once per second.

The SpMet Alarm Limits Display shows the upper and lower alarm limits. When the measured value is outside of the alarm limits, the SpMet measurement display flashes and an alarm will sound.

The system messages generated by the instrument are displayed in the System Message Area. See Section 5, System Messages.

The measurement of carbon monoxide concentration levels is displayed in units of percentage SpCO. When a sensor is not connected to a patient and during pulse search, the display will show dashed lines and the message Sensor Off will appear at the top of the display screen. The carboxyhemoglobin is calculated and the display is updated at a frequency of once per second.

The SpCO Alarm Limits Display shows the upper and lower alarm limits. When the measured value is outside of the alarm limits, the SpCO measurement display flashes and an alarm will sound.

The measurement of total hemoglobin concentration levels is displayed in units of grams per deciliter (g/dL) or milimoles per liter (mmol/L). The upper and lower SpHb alarm limits are also displayed next to the SpHb measurement. When a sensor capable of reading SpHb is not connected to a patient, the display will show dashed lines and the message “Sensor Off” will appear at the top of the display screen. The display will show dashed lines during pulse search. The total hemoglobin is calculated and the display is updated at a frequency of once per second

Radical-7R Pulse CO-Oximeter Operator’s Manual 2-3

System Description

HANDHELD FRONT PANEL (CONTINUED)

17.0

10.5

SpHb ALARM LIMITS DISPLAY

TOUCH KEY CONTROL BUTTONS

RESERVED

ALARM

SILENCE BUTTON

SPEAKER

PATIENT CABLE CONNECTOR

POWER/ON/OFF BUTTON

The SpHb Alarm Limits Display shows the upper and lower alarm limits. When the measured value is outside of the alarm limits, the SpHb measurement display flashes and an alarm will sound.

Press a Touch Key Control Button to select the corresponding touch key icon. See Section 4, Touch Key Control Buttons and Icons for more details.

Reserved for future use.

Press the Alarm Silence Button to temporarily silence patient and low battery alarms. Press the Alarm Silence Button when the “Sensor Off” message is flashing (i.e. the sensor is removed from the patient) to acknowledge the end of monitoring. In this state, all further alarms are suspended until the Pulse CO-Oximeter star ts measuring SpO2, SpCO, SpMet, SpHb and pulse rate again.

NOTE: System failure alarms can be silenced by pressing the Power/Standby or Alarm Silence Button. If the Power/Standby Button does not silence the system fault alarm, press the Alarm Silence Button.

The speaker indicates audio alarms. Care should be taken not to cover the speaker and muffle the audible alarm volume.

Connect a patient cable or a direct cable sensor into the Handheld Radical-7R by plugging the cable into the Patient Cable Connector. Use only Masimo compatible sensors and cables with this Pulse CO-Oximeter. See Section 8, Sensors and Patient Cables, for more details

Press the Power/On/Off Button to turn the instrument on. Press, hold the button for more than 2 seconds and then release the button to turn the instrument off..

The Touch Key Icons indicate the software menu items that can be selected through the Touch Key Control Buttons. Pressing a Touch Key Control Button next to an icon selects the option.

The Pulse Waveform Display shows the acquired plethysmographic waveform. The plethysmographic waveform is scaled with signal strength. Signal strength is defined as the relation of arterial pulsatile signal to the non-pulsatile signal component

The measurement of total oxygen content is displayed in units of milliliter per deciliter

PVI is displayed as a percentage. The lower the number, the less variability there is in the PI over a respiratory cycle.

TOUCH KEY

ICONS

PULSE

WAVEFORM

DISPLAY

SpOC

MEASUREMENT

DISPLAY

PLETH

VARIABILITY

INDEX

2-4 Radical-7R Pulse CO-Oximeter Operator’s Manual

System Description

HANDHELD FRONT PANEL (CONTINUED)

APOD

140

100

SIGNAL IQ

PERFUSION

INDEX

SENSITIVITY

PULSE RATE

ALARM LIMITS

DISPLAY

PULSE RATE

SIQa

MEASUREMENT

DISPLAY

RESPIRATION

RATE ALARM

LIMITS DISPLAY

RESPIRATION

RATE

MEASUREMENT

DISPLAY

SpHct

MEASUREMENT

DISPLAY

The Signal IQ shows the acquired signal quality and the timing of the pulse.

The Perfusion Index indicates numerically the percentage of pulsatile signal to non-pulsatile signal (pulse strength).

The sensitivity icon is shown on the Radical-7R display to indicate if the Radical 7R is set to operate in Normal, Maximum (MAX) or Adapative Probe Off Detection (APOD) mode. When in normal mode, this area will appear blank.

The Pulse Rate Alarm Limits Display shows the upper and lower pulse rate alarm limits. When an alarm limit is exceeded, the pulse rate value and the violated limit flashes.

The Pulse Rate Measurement Display shows the patient’s pulse rate in beats per minute. The upper and lower pulse rate alarm limits are also displayed next to the pulse rate measurement. The pulse rate is calculated and the display is updated at a frequency of once per second.

The SIQa Measurement Display shows the confidence level of the Acoustic Respiration measurement signal quality as a percentage between 1 and 100.

The Respiration Rate (RRa) Alarm Limits Display shows the upper and lower respiration rate alarm limits. When an alarm limit is exceeded, the respiration rate value and the violated limit flashes.

The Respiration Rate Measurement Dsiplay shows the patient's respiration rate in breaths per minute (bpm). The upper and lower alarm limits are also displayed next to the respiration rate measurement.

The measurement of hematocrit is displayed in units of percentage SpHct .

ACOUSTIC (SIQa)

INDICATOR

SIQa

RESPIRATION

INDICATOR

Radical-7R Pulse CO-Oximeter Operator’s Manual 2-5

SIQa displays the confidence level of the measured signal. The SIQa value ranges from 0-100% with each bar representing 10%. The bars are colored green unless the SIQa value is in the range 0 > = 10%, in which case the signal bar shall be colored RED.

The Respiration Indicator (RI) displays the sound level of the measured signal. A 10 segment bar graph represents the acoustic signal at the respiration sensor. RI values range from

0 - no green bars lit

0 - 0.20 - middle 2 bars lit.

0.20 - 0.40 - middle 4 bars lit

0.40 - 0.60 - middle 6 bars lit

0.60 - 0.80 - middle 8 bars lit

0.80 - 1.00 - all bars lit

0 to 1.

System Description

HANDHELD FRONT PANEL (CONTINUED)

HANDHELD BACK PANEL

The Handheld back panel features the interconnection to the Docking Station, an accessory mount for the pole clamp accessory and access to the Handheld battery pack.

DOCKING STATION CONNECTOR

POLE CLAMP ACCESSORY HOLDER

The Radical-7R Handheld interfaces with the Docking Station through this connector.

The optional Pole Clamp accessory attaches to this holder. See the Directions for Use of the Pole Clamp accessory for attachment instructions.

The Radical-7R Handheld is powered by a NiMH battery

BATTERY PACK

located in this compartment. For battery care and replacement please see Section 9, Replacing the Batteries.

2-6 Radical-7R Pulse CO-Oximeter Operator’s Manual

System Description

Radical-7R Pulse CO-Oximeter Standalone

When the Radical-7R Pulse CO-Oximeter Handheld is placed into the Docking Station, the

Radical-7R Pulse CO-Oximeter becomes a full-featured standalone instrument. The Radical-7R

Pulse CO-Oximeter Standalone acts as a battery charger for the Handheld instrument and has

AC power connection capabilities. If the AC power from the wall outlet is temporarily interrupted,

then the battery in the Handheld instrument will allow continuous operation. The Standalone can

also interface to serial instruments, nurse call or analog output instruments, and multiparameter

patient monitors through a SatShare cable.

There are several models of Docking Stations available. The following table outlines which

features are available for each model of Docking Station.

DOCKING STATION FEATURES RDS-1 RDS-1B RDS-2 RDS-3

AC Power Input

SatShare Interface

Serial RS-232 Interface

Nurse Call/Analog Output Interface

10-hour Extended Battery

Docking Station Battery Charging Indicator

Handheld Battery Charging Indicator

Visual Alarm Indicator

AC Power Indicator

Docking Indicator

Handheld Battery Deep Discharge Support

Docking Station Battery Deep Discharge Support





 





 



 

Not supported by Radical-7R

The RDS-1 and RDS-3 are optionally available with Patient SafetyNet and RadNet capability.

Radical-7R Pulse CO-Oximeter Operator’s Manual 2-7

17 7

10.0

SpOC

ml/dl

SpHb g/dl

---

System Description

STANDALONE FRONT PANEL

The following figure and corresponding text review the features of the Radical-7R Standalone

instrument.

DOCKING STATION

BATTERY CHARGING INDICATOR

HANDHELD

BATTERY CHARGING INDICATOR

VISUAL

ALARM INDICATOR

AC POWER INDICATOR

DOCKING INDICATOR

The Docking Station Battery Charging Indicator is illuminated when the Docking Station battery is charging. The indicator blinks just prior to charging. The Charging Indicator does not illuminate when the battery is fully charged or when the battery is not present.

The Handheld Battery Charging Indicator is illuminated when the Handheld battery is charging. The indicator blinks just prior to charging. The Charging Indicator does not illuminate when the battery is fully charged or when the battery is not present.

The Visual Alarm Indicator is illuminated when an alarm condition is active and the Alarm Status Indicator is shown

The AC Power Indicator is illuminated when the Radical7R Docking Station is plugged into AC line power.

The Docking Indicator is illuminated when the Handheld instrument is turned on and is properly interfaced to a Docking Station.

NOTE: When the Radical-7R Pulse CO-Oximeter Standalone is turned on, all indicator LEDs

initially turn on and off at start up.

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