Masimo RAD7CPL Radical 7R User Manual LAB 6189A indd

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2. User Manual 2

User Manual 2

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.: 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.

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

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 unin-

tended 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

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.

■ SpO2 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 SpO2 measurement.

■

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 SpO2 may be decreased by levels of MetHb of up

to approximately 10% to 15%. At higher levels of MetHb, the SpO2 may 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 SpO2 and

SpCO measurements.

■

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

■ 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 SpO2 readings.

■

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 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.

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED)

iii

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

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

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

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

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

Table of Contents

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

Table of Contents

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 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

Table of Contents

vii

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

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

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 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 speciﬁ city 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 reﬂ ect 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 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 Radical-

7R monitor.

■ Detachable portable handheld for patient transport.

1 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

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

SpO2 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 ngertip 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.

SpHb g/dl

10.0

SpOCml/dl

---

3.00

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. Instrument

2. Patient Cable

3. Sensor

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

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 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 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

2 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 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

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.

1 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

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)

0.5

600 800

1.0

1.5

2.0

2.5

3.0

3.5

4.0

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 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 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

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

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

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 (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 ﬁ ltering. Adaptive

ﬁ lters 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 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.

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

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

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

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

MASIMO SET DST®

Overview

MASIMO RAINBOW SET PARALLEL ENGINES

This ﬁ gure is for conceptual purposes only.

SpOC

FST

MST

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

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.

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.

SpHb g/dl

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 SpO2 AND 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

---

--- ---

---

SpOC ml/dl

30 29 28

SpHb g/dl

---

--- ---

---

SpOC ml/dl

RI SIQa

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

System Description

HANDHELD FRONT PANEL (CONTINUED)

HANDHELD

RELEASE

BUTTON

Press down the Handheld Release Button and pull the Handheld

instrument off the Docking Station.

296

SpO2

MEASUREMENT

DISPLAY

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.

3__

SATURATION

ALARM LIMITS

DISPLAY

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.

ALARM

STATUS

INDICATOR

The alarm status indicator (a bell) can be shown with or without a

slash. It flashes when an alarm condition is present.

55.6

SpMet

MEASUREMENT

DISPLAY

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.

63.0

SpMet ALARM

LIMITS DISPLAY

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.

7Sensor Off

SYSTEM

MESSAGE

AREA

The system messages generated by the instrument are displayed

in the System Message Area. See Section 5, System Messages.

814

SpCO

MEASUREMENT

DISPLAY

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.

910

SpCO ALARM

LIMITS DISPLAY

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.

10 14.0

SpHb

MEASUREMENT

DISPLAY

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

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

2System Description

HANDHELD FRONT PANEL (CONTINUED)

11 17.0

10.5

SpHb ALARM

LIMITS DISPLAY

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.

TOUCH KEY

CONTROL

BUTTONS

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.

13 RESERVED Reserved for future use.

ALARM

SILENCE

BUTTON

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 starts

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.

15 SPEAKER

The speaker indicates audio alarms. Care should be taken not to

cover the speaker and muffle the audible alarm volume.

16 PATIENT CABLE

CONNECTOR

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

17 POWER/ON/OFF

BUTTON

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..

18 TOUCH KEY

ICONS

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.

PULSE

WAVEFORM

DISPLAY

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

20 18

SpOC

MEASUREMENT

DISPLAY

The measurement of total oxygen content is displayed in units of

milliliter per deciliter

21 5

PLETH

VARIABILITY

INDEX

PVI is displayed as a percentage. The lower the number, the less

variability there is in the PI over a respiratory cycle.

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

System Description

HANDHELD FRONT PANEL (CONTINUED)

22 SIGNAL IQ

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

pulse.

23 8PERFUSION

INDEX

The Perfusion Index indicates numerically the percentage of

pulsatile signal to non-pulsatile signal (pulse strength).

24 APOD SENSITIVITY

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.

25 140

PULSE RATE

ALARM LIMITS

DISPLAY

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.

70 PULSE RATE

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.

100

SIQa

MEASUREMENT

DISPLAY

The SIQa Measurement Display shows the confidence level of the

Acoustic Respiration measurement signal quality as a percentage

between 1 and 100.

RESPIRATION

RATE ALARM

LIMITS DISPLAY

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.

RESPIRATION

RATE

MEASUREMENT

DISPLAY

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.

30 41

SpHct

MEASUREMENT

DISPLAY

The measurement of hematocrit is displayed in units of percentage

SpHct .

SIQa

ACOUSTIC (SIQa)

INDICATOR

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.

RESPIRATION

INDICATOR

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 to 1.

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

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

2System Description

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

The Radical-7R Handheld interfaces with the Docking

Station through this connector.

POLE CLAMP

ACCESSORY

HOLDER

The optional Pole Clamp accessory attaches to this holder.

See the Directions for Use of the Pole Clamp accessory for

attachment instructions.

BATTERY PACK

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

located in this compartment. For battery care and

replacement please see Section 9, Replacing the Batteries.

123

HANDHELD FRONT PANEL (CONTINUED)

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

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 Interface1

Serial RS-232 Interface1 

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  

1 Not supported by Radical-7R

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

2-8 Radical-7R Pulse CO-Oximeter Operator’s Manual

2System Description

STANDALONE FRONT PANEL

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

instrument.

DOCKING

STATION

BATTERY

CHARGING

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.

HANDHELD

BATTERY

CHARGING

INDICATOR

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.

VISUAL

ALARM

INDICATOR

The Visual Alarm Indicator is illuminated when an alarm

condition is active and the Alarm Status Indicator is shown

4AC POWER

INDICATOR

The AC Power Indicator is illuminated when the Radical-

7R Docking Station is plugged into AC line power.

5DOCKING

INDICATOR

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.

10.0

SpOC ml/dl

SpHb g/dl

---

--- ---

---

Radical-7R Pulse CO-Oximeter Operator’s Manual 2-9

System Description

STANDALONE BACK PANEL

1SERIAL OUTPUT

CONNECTOR

Use the Serial Output Connector with a ferrite bead

installed to connect a serial instrument, including a serial

printer, a monitoring system or PC to the Radical-7R Pulse

CO-Oximeter. The data is provided in standard RS-232C

format. See Section 7, Serial Interface Specifications.

All external instrument connections to the Serial Output

Connector must be IEC-60950 compliant.

ANALOG OUTPUT/

NURSE CALL

CONNECTOR

Use the Nurse Call Connector with a ferrite bead installed

to interface with an analog output instrument, such as a

chart recorder or nurse call system. All external instrument

connections to the Analog Output / Nurse Call Connector

must be IEC-60950 compliant.

3SATSHARE CABLE

CONNECTOR

Use the SatShare Cable Connector to connect a SatShare cable to

the SpO2 input connector of a multiparameter patient monitor. All

external instrument connections to the SatShare Cable Connector

must be IEC-60601-1-1 compliant. SatShare cables are available to

interface with most major multiparameter patient monitors. Check the

label on the SatShare cable and the SatShare Directions for Use to

ensure that the correct cable is used for each type of patient monitor.

4POWER ENTRY

MODULE

The power entry module contains the input connector for

AC power and two fuses. The AC input provides power to

the system from the AC line. Always connect the Pulse

CO-Oximeter to the mains power for continuous operation and/

or battery recharging.

NOTE: Use the power cord as the means to disconnect the

instrument from the mains power supply.

EQUIPOTENTIAL

GROUND

CONNECTOR

Use the Equipotential Ground Connector for grounding.

123

2-10 Radical-7R Pulse CO-Oximeter Operator’s Manual

2System Description

SYMBOLS

The following symbols may be found on the Radical-7R Pulse CO-Oximeter, Docking Station or

packaging and are defined below:

NOTE:

Some of the interfaces and symbols are not available on all versions of the Docking Station.

SYMBOLS DEFINITION

RS-232

SatShare Interface

Equipotential Ground Terminal

See Instructions for Use

Fuse Replacement

Analog Out Interface

Nurse Call Interface

WEEE Compliant

Mark of Conformity to European Medical Instrument Directive

93/42/EEC

Rx ONLY Federal law restricts this instrument to sale by or on the order of

a physician (USA audiences only)

Underwriter's Laboratories Inc. certiﬁ cation

5%-95% RH Storage humidity range: 5% to 95%

-40 C

+70 C

+1060 hPa - +500 hPa

95 mmHg - 375 mmHg

Storage temperature range: +70˚C to -40˚C

Storage altitude range: +1600hPa to +500hPa

Keep dry

Fragile/breakable, handle with care

Year of Manufacture

IPX1 Protection against liquid drops falling vertically

Deﬁ brillation Proof Type BF

EC REP EU authorized representative

CAUTION

Manufacturer

Radical-7R Pulse CO-Oximeter Operator’s Manual 2-11

Radical-7R Monitor Interface

In addition to being a full-featured Handheld and Standalone Pulse CO-Oximeter, the

Radical-7R Pulse CO-Oximeter’s unique SatShare interface links the Radical-7R Pulse

CO-Oximeter to most existing multiparameter patient monitors through the pulse oximetry

patient cable or SpO2 input connector.

SpHb g/dl

10.0

SpOC

■ Upgrades any approved and validated monitor to Masimo SET performance by

using the calculated SpO2 and pulse rate determined by Radical-7R to simulate an

ideal waveform, which is sent to the validated multiparameter patient monitor.

■ Connects into the SpO2 patient cable or SpO2 input connector of the multiparameter

patient monitor.

CAUTIONS:

■ 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 SpO2 AND PULSE RATE CAN BE DISPLAYED ON THE MULTIPARAMETER

MONITOR WITH SATSHARE.

System Description

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

Introduction

Before the Radical-7R Pulse CO-Oximeter can be used in a clinical setting, it needs to be

inspected, properly setup and the batteries need to be fully charged.

Unpacking and Inspection

Remove the instrument from the shipping carton and examine it for signs of shipping damage.

Check all materials against the packing list. Save all packing materials, invoice and bill of lading.

These may be required to process a claim with the carrier.

If anything is missing or damaged, contact the Technical Service Department. The contact

address and phone numbers are listed in Section 9, Service and Repair.

Preparation for Monitoring

The following sections of the manual describe the preparation, set-up and initial installation of

the Radical-7R Pulse CO-Oximeter.

RADICAL-7R DOCKING STATION POWER REQUIREMENTS

Always use a hospital grade, AC power cable to connect the Radical-7R Pulse CO-Oximeter

to an AC power source. Do not connect the Radical-7R Docking Station to an AC outlet

controlled by a switch because the power to the instrument may be inadvertently switched

off.

Verify the AC power voltage and line frequency before use. Verify that the power source can

provide adequate power rating as indicated on the rear panel of the Radical-7R Docking

Station.

The Radical-7R Pulse CO-Oximeter is designed to operate on 100 to 240VAC, 47-63 Hz. The

instrument is rated at 55 VA max.

Connect a hospital grade power cable to the power entry module of the Radical-7R instrument

(IEC-320 connector type at the instrument). Connect the power cable to an AC power source.

Ensure that the instrument is adequately powered by verifying that the AC power indicator on

the Docking Station is illuminated.

CAUTION:

■ DO NOT UNDER ANY CIRCUMSTANCES REMOVE THE GROUNDING CONDUCTOR

FROM THE POWER PLUG.

■ DO NOT USE EXTENSION CORDS OR ADAPTERS OF ANY TYPE. THE POWER CORD

AND PLUG MUST BE INTACT AND UNDAMAGED.

■ USE THE POWER CORD AS THE MEANS TO DISCONNECT THE INSTRUMENT

FROM THE AC POWER AT THE WALL OUTLET.

■ IF THERE IS ANY DOUBT ABOUT THE INTEGRITY OF THE PROTECTIVE EARTH

CONDUCTOR ARRANGEMENT, OPERATE THE PULSE CO-OXIMETER ON INTERNAL

BATTERY POWER UNTIL THE AC POWER SUPPLY PROTECTIVE CONDUCTOR IS

FULLY FUNCTIONAL.

■ TO ENSURE PATIENT ELECTRICAL ISOLATION, CONNECT ONLY TO OTHER

EQUIPMENT WITH ELECTRICALLY ISOLATED CIRCUITS.

■ DO NOT CONNECT TO AN ELECTRICAL OUTLET CONTROLLED BY A WALL

SWITCH OR DIMMER.

Setup

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

INITIAL BATTERY CHARGING

Before use, the Radical-7R Pulse CO-Oximeter Handheld battery and the optional Docking

Station battery need to be fully charged.

To charge the batteries:

1. Attach the Handheld instrument to the Docking Station.

2. Plug in the AC power cord to power entry module. Make sure it is securely plugged in.

3. Plug the AC power cord into an AC power source.

4. Verify that the batteries are charging.

The battery charging LED indicators on the Docking Station flash prior to charging and remain

illuminated while the batteries are charging.

Refer to Section 9, Battery Operation and Maintenance, for proper battery charging.

INITIAL INSTALLATION

Place the Docking Station on a stable hard flat surface near the patient. Always place the

Radical-7R Pulse CO-Oximeter instrument on a dry surface. Maintain a minimum of 3 cm (1

inch) free space around the Radical-7R Pulse CO-Oximeter Standalone instrument. Make

sure that the Radical-7R speaker is not covered to avoid a muffled alarm sound.

The Radical-7R Pulse CO-Oximeter Handheld, Docking Station or Standalone should not be

operated outside the following environmental conditions:

OPERATING ENVIRONMENTAL CONDITIONS

TEMPERATURE +5°C to +40°C, +41°F to +104°F

HUMIDITY 5% to 95%, non-condensing

OPERATING ALTITUDE 1060 mbar to 500 mbar pressure

-1000 ft to 18,000 ft (-304 m to 5,486 m)

Configure the instrument for your regional power line frequency (50 or 60 hz) if needed. Default

is 60 hz (standard for the United States). See Section 4, Operation, Config.

CAUTION: THE INSTRUMENT MUST BE CONFIGURED TO MATCH YOUR LOCAL

POWER LINE FREQUENCY TO ALLOW FOR THE CANCELLATION OF NOISE

INTRODUCED BY FLUORESCENT LIGHTS AND OTHER SOURCES

FACTORY DEFAULT SETTINGS

The following outlines the Radical-7R Pulse CO-Oximeter option settings that can be

changed by the user but will revert back to after a power cycle.

OPTION DEFAULT SETTING

LCD SCREEN ILLUMINATION

AC Power

Battery Power

Set to maximum, level 5

Set to minimum, level 1

SENSITIVITY Set to APOD mode

Setup

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

Setup

SatShare Setup

The Radical-7R Pulse CO-Oximeter has been proven to be accurate during patient motion

and low perfusion conditions. Saturation and pulse rate values from the Radical-7R Pulse

CO-Oximeter may be displayed on a multiparameter monitor through the SatShare feature.

The SatShare feature provides an ideal, simulated waveform corresponding to the

measured saturation and pulse rate values determined by the Masimo SET technology.

This waveform may be used to display these values on multiparameter monitors through

the multiparameter oximetry sensor or input connector.

It is recommended that the Radical-7R Pulse CO-Oximeter is positioned close to the

multiparameter monitor with the Radical-7R Pulse CO-Oximeter screen visibly displaying

the plethysmographic waveform and the saturation and pulse rate measurements.

CAUTION: SIMULTANEOUS USE OF SATSHARE AND SERIAL PORT IS NOT

SUPPORTED.

SATSHARE SETUP

1. Select the SatShare cable that is appropriate for the multiparameter monitor that is

being connected. Check the Masimo web site at www.masimo.com for the latest list

of available SatShare cables and validated instruments.

Connect the labeled end of the cable to the SatShare Cable Connector port on the

back of the Docking Station. Tighten the connector screws for a secure connection.

Connect the other end of the SatShare cable either to the sensor connector of the

multiparameter monitor’s SpO2 cable or directly to the SpO2 connector on the monitor.

4. Verify that the Radical-7R Pulse CO-Oximeter recognizes the correct cable.

The name of the SatShare cable will be displayed on the LCD screen when the

SatShare mode is functional.

5. Set the multiparameter monitor’s high and low saturation and pulse rate alarm

limits as appropriate.

6. Set the multiparameter monitor’s averaging time to the lowest setting (i.e. fastest

response). The Radical-7R Pulse CO-Oximeter’s ideal waveform necessitates

the need for additional averaging by the monitor. If the multiparameter monitor’s

averaging time is not changed, the time to display physiological changes in

saturation on the monitor will be increased with SatShare. However, the delay can

be minimized by reducing the multiparameter monitor’s averaging time.

SpHb g/dl

10.0

SpOC

3-4 Radical-7R Pulse CO-Oximeter Operator’s Manual

7. While in the SatShare mode, if there are any significant discrepancies between

the readings from the Radical-7R Pulse CO-Oximeter and those on the monitor

displaying the values obtained from SatShare, the values reported by the Radical-

7R Pulse CO-Oximeter are to be considered the correct values.

8. To use the Radical-7R Pulse CO-Oximeter with SatShare while it is not connected

to AC power, set the Power Save parameter in the General menu to “No” and refer

to Section 4 Operation. Please note that if the Radical-7R Pulse CO-Oximeter

is used in this mode, the length of time the Radical-7R Pulse CO-Oximeter can

operate on battery power will be significantly diminished.

9. Set the SatShare Numbers and the Interface Alarms SpO2/pulse rate parameters

in the General menu according to customer preference.

When Rainbow parameters (SpCO, SpMet, SpHb, etc.) are configured, Interface

Alarms "SpO2/BPM" can be set to “Yes” or “No”. The “Yes” setting allows SpO2

and pulse rate audible alarms at both the Radical-7R and the interfaced system.

The “No” setting mutes the SpO2 and pulse rate audible alarms at the Radical-7R

while allowing SpO2 and pulse rate audible alarm alerts at the interfaced system.

The “No” setting prevents both systems (Radical-7R and interfaced system) from

producing audible alarms at the same time. See section 4: General.

NOTE: The Radical-7R reverts to Interface Alarm "SpO2/BPM" “Yes” during power

interruptions or when the SatShare connection is lost or the device becomes

separated from the docking station. This ensures that the Radical-7R provides

audible alarms for SpO2 and pulse rate when the connection to the interfaced

system becomes compromised.

10. If displaying the simulated waveform is not desirable, it is recommended to turn off

the plethysmographic waveform display of the multiparameter patient monitor.



SATSHARE SIGNALS ARE IDEAL SIMULATED WAVEFORMS CORRESPONDING TO THE

CALCULATED SATURATION AND PULSE RATE VALUES AND DO NOT CONTAIN ALL OF THE

INFORMATION CONTAINED IN PHYSIOLOGICAL WAVEFORMS. THE MULTIPARAMETER PATIENT

MONITOR TRANSLATES THESE SIGNALS INTO SATURATION AND PULSE RATE VALUES.



DURING SATSHARE OPERATION, THE AUDIBLE ALARMS MAY BE MUTED ON THE RADICAL-7R

PULSE CO-OXIMETER. WHEN THE AUDIBLE ALARM IS MUTED (INDICATED BY THE BELL WITH A

SLASH THROUGH IT) ON THE RADICAL-7R PULSE CO-OXIMETER, USE THE MULTI-PARAMETER

MONITOR FOR AUDIBLE ALARM INDICATION.



DURING SATSHARE OPERATION DO NOT USE THE PLETHYSMOGRAPHIC WAVEFORM

DISPLAY ON THE MULTIPARAMETER MONITOR FOR DIAGNOSTIC PURPOSES. INSTEAD,

USE THE PLETHYSMOGRAPHIC WAVEFORM DISPLAYED ON THE RADICAL-7R PULSE

CO-OXIMETER SCREEN



TO AVOID EXCESSIVE BATTERY DISCHARGING, DO NOT CONNECT ANY EQUIPMENT TO THE

SATSHARE CONNECTOR UNLESS THE RADICAL-7R PULSE CO-OXIMETER IS CONNECTED TO

THE AC MAINS POWER SUPPLY.



ONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED.



ONLY SpO2 AND PULSE RATE CAN BE DISPLAYED ON THE MULTIPARAMETER MONITOR

WITH SATSHARE.

Setup

Radical-7R Pulse CO-Oximeter Operator’s Manual 3-5



THE RADICAL-7R REVERTS TO INTERFACE ALARM SpO2/BPM "YES" DURING POWER

INTERRUPTIONS OR WHEN THE SATSHARE CONNECTION IS LOST OR THE INSTRUMENT

BECOMES SEPARATED FROM THE DOCKING STATION. THIS ENSURES THAT THE RADICAL-

7R PROVIDES AUDIBLE ALARMS FOR SpO2 AND PULSE RATE WHEN THE CONNECTION TO

THE INTERFACED SYSTEM BECOMES COMPROMISED.

Setup

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

Operation

Introduction

To operate the Radical-7R Pulse CO-Oximeter effectively, the instrument must be set up

properly and the operator must:



Know how the Pulse CO-Oximeter derives its readings (see Section 1, Pulse CO-Oximetry).

 Be familiar with its controls, components and operation.

 Understand its status and alarm messages (see Section 5, Alarm Identification, System

Messages and Section 6, Troubleshooting).

Basic Operation

GENERAL SETUP AND USE

1. Inspect the Pulse CO-Oximeter case for damage.

2. Connect a patient cable, Dual Rainbow Cable or a direct cable sensor to the Patient

Cable Connector of the Radical-7R Pulse CO-Oximeter. Make sure it is a firm connection

and the cable is not twisted, sliced or frayed.

3. If utilizing the Standalone setup, ensure that the power cord is plugged into the Power

Cable Connector of the Docking Station and into the AC power.

4. If utilizing a patient cable or Dual Rainbow Cable, select a sensor that is compatible

with the Pulse CO-Oximeter before connecting it to the patient cable or instrument. See

section 8, Sensors and Patient Cables. If using a single patient adhesive or disposable

sensor, check that the emitter (red light) and the detector are properly aligned. Remove

any substances that may interfere with the transmission of light between the sensor’s light

source and detector. If using an Acoustic Respiration sensor, ensure that the patient's neck

area is clean and dry.

5. Attach the sensor to the patient. Refer to the Directions for Use of the sensor.

6. Connect the sensor to the instrument (or patient cable) with the logos lining up; make sure

it is a firm connection.

7. Press the Power/Standby button to turn the Pulse CO-Oximeter on.

8. Make sure the display window is free of alarm and system failure messages (see Section

5, Alarms and Messages).

9. On the display, verify:



The high and low alarm limits for SpO2, RRa, SpMet, SpCO, SpHb, PI, PVI, and pulse rate.



The readings for SpO2, RRa, SpMet, SpCO, SpHb, SpOC, SpHct, PI, PVI, and pulse rate.

NOTE: “- - -” initially shows in the numeric display fields for all the parameters/measurements

when the Radical-7R is turned on. As the system starts monitoring, the numeric display fields

update (refresh). The numeric display fields for the parameters/measurements begin to show

numbers during the refresh cycles even though the numbers have not stabilized; during this

period, the measurement label will flash to indicate that the measurement value is being

processed. When the flashing stops, the number has stabilized. In the case of SpHb and PVI, the

numeric value will be displayed upon initial stabilization of the number, and the parameter label

will continue to flash for an additional processing period to reach optimal confidence.

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

GENERAL SETUP AND USE (CONTINUED)

Parameter/Measurement Approximate Time (in seconds) until Number Stabilization

SpO2, PI, Pulse Rate 15 seconds

SpCO, SpMet 25 seconds

SpHb 90 seconds

PVI 90 seconds

RRa 60 seconds

10.

Verify that the patient alarms are functional by setting the high and low SpO2, SpMet, SpCO,

SpHb, PI, PVI, pulse rate and respiration rate alarm limits beyond the patient readings.

 An alarm tone sounds.

 The violated alarm limit and reading flash on the display.

 The red alarm indicator flashes on the Docking Station (standalone operation).

11. Verify the sensor alarms are functional by removing the sensor from the sensor site.

NOTE: If using SpO2 and RRa, only the SpO2 audible alarm tone will sound.

 "Sensor Off" appears in the message area of the graphic sensors display.

 The alarm tone sounds.

 The alarm indicator flashes.

 Disconnect the sensor from the patient cable or instrument.

 Confirm that "Sensor Off" appears in the message area of the graphic display.

12. Verify alarm silence operation.

 Create an alarm condition by lowering the SpO2 or pulse rate high alarm limits

beyond the patient readings.

NOTE: If using SpO2 and RRa, only the SpO2 audible alarm tone will sound.

 Press the Alarm Silence button.

 The alarm tone ceases for the displayed amount of time.

 Perform the above steps for the SpCO and SpMet alarm limits.

13. To begin patient monitoring:

 Adjust the alarm limits.

14. Verify the sensor is on correctly and that the measured data is appropriate, see

Section 4, Successful Monitoring.

15. Monitor the patient.

16. After monitoring is complete, remove the sensor from the patient and store or dispose of

the sensor according to governing rules. See the Directions for Use of the sensor.

17. Press and hold the Power/Standby Button for 2 seconds to turn the instrument off.

Successful Monitoring

The following general points will aid in ensuring Pulse CO-Oximetry monitoring success.

■

Place the sensor on a site that has sufficient perfusion and provides proper alignment of the LEDs and detector.

■ Place the sensor on a site that has unrestricted blood flow.

■ Do not secure a sensor with tape.

■ Do not select a site near potential electrical interference (electrosurgical unit, for example).

■ Read the sensor Directions for Use for proper sensor application.

Operation

Radical-7R Pulse CO-Oximeter Operator’s Manual 4-3

Operation

NOTE: When a Masimo Rainbow Sensor is properly connected to the patient, the instru-

ment normally goes through a 20-30 second sensor calibration/pulse search routine and

then displays numeric values installed on the instrument and supported by the sensor.

It also provides graphical displays for plethysmographic waveform, Signal Identification

and Quality Indicator (Signal IQ®). However, if the sensor calibration/pulse search routine

is unsuccessful for Rainbow parameters/measurements, the instrument automatically

switches to a “SpO2 Only Mode” to provide SpO2, PR, PI and PVI values.

MASIMO PULSE CO-OXIMETRY SENSORS

Before use, carefully read the Masimo sensor Directions for Use.

Use only Masimo sensors for pulse oximetry or pulse CO-Oximetry measurements.

Tissue damage can be caused by incorrect application or use of a sensor, for example by

wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor Directions for

Use to ensure skin integrity and correct positioning and adhesion of the sensor.

NOTE: When monitoring Acoustic Respiration, Masimo recommends minimally monitoring

both oxygenation (SpO2) and respiration (RRa).

If a Masimo Rainbow Direct Connect Reusable Sensor is being used and “SpO2 Only Mode”

appears on the LCD display screen, perform one of the following steps to obtain Rainbow

values:

■

Remove the sensor from the patient and properly reapply (recommended).

■

Remove the cable connector from the instrument and reconnect.

■

Turn the power off and on at the instrument.

If a Masimo Rainbow Adhesive Sensor is being used and “SpO2 Only Mode” appears on the

display screen, perform one of the following steps to to obtain Rainbow values:

■

Disconnect sensor cable connector from patient cable connector and reconnect

(recommended).

■

Verify proper sensor placement. Remove sensor from patient and reapply, if necessary.

■

Remove patient cable connector from the instrument and reconnect.

When high intensity extreme lights (including pulsating strobe lights) are directed at the sensor or other

sources of interference are present, cover the sensor by applying a Masimo Optical Light Shield.

CAUTIONS

■

DO NOT USE DAMAGED SENSORS. DO NOT USE A SENSOR WITH EXPOSED OPTICAL

OR ELECTRICAL COMPONENTS. DO NOT IMMERSE THE SENSOR IN WATER, SOLVENTS,

OR CLEANING SOLUTIONS (THE SENSORS AND CONNECTORS ARE NOT WATERPROOF).

DO NOT STERILIZE BY IRRADIATION, STEAM, AUTOCLAVE OR ETHYLENE OXIDE UNLESS

OTHERWISE INDICATED IN THE SENSOR DIRECTIONS FOR USE. SEE THE CLEANING

INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR ALL MASIMO REUSABLE SENSORS.

■

DO NOT USE DAMAGED PATIENT CABLES. DO NOT IMMERSE THE PATIENT CABLES IN

WATER, SOLVENTS, OR CLEANING SOLUTIONS (THE PATIENT CABLE CONNECTORS ARE NOT

WATERPROOF). DO NOT STERILIZE BY IRRADIATION, STEAM, AUTOCLAVE OR ETHYLENE OXIDE.

■

DO NOT ATTEMPT TO REPROCESS, RECONDITION OR RECYCLE MASIMO SENSORS OR

PATIENT CABLES AS THESE PROCESSES MAY DAMAGE THE ELECTRICAL COMPONENTS,

POTENTIALLY LEADING TO PATIENT

HARM.

■

EXCESSIVE AMBIENT NOISE MAY AFFECT THE ACCURACY OF THE RESPIRATION

RATE READING FROM THE ACOUSTIC RESPIRATION SENSOR.

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

4Operation

NUMERIC DISPLAY - SpO2

Stability of the SpO2 readings may be a good indicator of signal validity. Although stability is a relative term,

experience will provide confidence in changes that are artifactual or physiological and the speed, timing, and

behavior of each. The stability of the readings over time is affected by the averaging mode being used. The

longer the averaging time, the more stable the readings tend to become. This is due to a dampened response

as the signal is averaged over a longer period of time than during shorter averaging times. However, longer

averaging times delay the response of the Pulse CO-Oximeter and reduce the measured variations of SpO2

and pulse rate. Inaccurate measurements may be caused by

■ Elevated levels of Carboxyhemoglobin.

■ Elevated levels of Methemoglobin.

■ Severe anemia.

■ Elevated Total Bilirubin levels.

■ Low arterial perfusion.

■ Motion artifact.

NUMERIC DISPLAY - PULSE RATE

The Pulse Rate displayed on the Radical-7R Pulse CO-Oximeter may differ slightly from the heart rate

displayed on ECG monitors due to differences in averaging times. There may also be a discrepancy

between cardiac electrical activity and peripheral arterial pulsation. Significant differences may indicate

a problem with the signal quality due to physiological changes in the patient or one of the instruments or

application of the sensor or patient cable. The pulsations from intra-aortic balloon support can cause the

pulse rate displayed on the Pulse CO-Oximeter to be significantly different than the ECG heart rate

NUMERIC DISPLAY - RRa

Rainbow Acoustic Monitoring continuously measures a patient’s respiration rate based on air-

flow sounds generated in the upper airway. Inaccurate measurements may be caused by:

■ Excessive ambient or environmental noise.

■ Improper sensor placement.

NUMERIC DISPLAY - SpCO

A stable SpCO reading is associated with correct sensor placement, small physiological

changes during the measurement and acceptable levels of arterial perfusion in the patient’s

fingertip (measurement site). Physiological changes at the measurement site are mainly

caused by fluctuations in the oxygen saturation, blood concentration and perfusion. Inaccurate

measurements may be caused by:

■ Levels of methemoglobin approximately 1.5% or above.

■ Intravascular dyes such as indocyanine green or methylene blue.

■ Abnormal hemoglobin levels.

■ Low arterial perfusion.

■ Low arterial oxygen saturation levels.

■ Elevated Total Bilirubin levels.

■ Motion artifact.

NUMERIC DISPLAY - SpMet

A stable SpMet reading is associated with correct sensor placement, small physiological

changes during the measurement and acceptable levels of arterial perfusion in the patient’s

fingertip (measurement site). Physiological changes at the measurement site are mainly

Radical-7R Pulse CO-Oximeter Operator’s Manual 4-5

Operation

caused by fluctuations in the oxygen saturation, blood concentration and perfusion. Inaccurate

measurements may be caused by:

■ Intravascular dyes such as indocyanine green or methylene blue.

■ Low arterial perfusion.

■ Low arterial oxygen saturation levels.

■ Elevated Total Bilirubin levels.

■ Motion artifact.

NUMERIC DISPLAY - SpHb

A stable SpHb reading is associated with correct sensor placement, small physiological changes

during the measurement and acceptable levels of arterial perfusion at the measurement site.

Physiological changes at the measurement site are mainly caused by fluctuations in the oxygen

saturation, blood concentration and perfusion. Inaccurate measurements may be caused by:

■ Intravascular dyes such as indocyanine green or methylene blue.

■ Low arterial perfusion.

■ Low arterial oxygen saturation levels.

■ Elevated Total Bilirubin levels.

■ Motion artifact.

NUMERIC DISPLAY - SPOC

A stable SpOC reading is associated with stable readings for both SpO2 and SpHb which

comes with correct sensor placement, small physiological changes during the measurement

and acceptable levels of arterial perfusion at the measurement site. Physiological changes

at the measurement site are mainly caused by fluctuations in the oxygen saturation, blood

concentration and perfusion. Inaccurate measurements may be caused by:

■ Intravascular dyes such as indocyanine green or methylene blue.

■ Low arterial perfusion.

■ Low arterial oxygen saturation levels.

■ Elevated Total Bilirubin levels.

■ Motion artifact.

■ Elevated levels of carboxyhemoglobin.

■ Elevated levels of methemoglobin.

■ Severe anemia may cause erroneous SpOC readings.

NUMERIC DISPLAY - SpHct

A stable SpHct reading is associated with stable readings for SpHb which comes with correct

sensor placement, small physiological changes during the measurement and acceptable levels

of arterial perfusion at the measurement site. Physiological changes at the measurement site

are mainly caused by fluctuations in the oxygen saturation, blood concentration and perfusion.

Inaccurate calculations may be caused by

■ Intravascular dyes such as indocyanine green or methylene blue.

■ Low arterial perfusion.

■ Low arterial oxygen saturation levels.

■ Elevated Total Bilirubin levels.

■ Motion artifact.

4-6 Radical-7R Pulse CO-Oximeter Operator’s Manual

SIGNAL INDICATION AND QUALITY INDICATOR (SIQ)

The Radical-7R Pulse CO-Oximeter display provides a visual indicator of the plethysmogram

signal quality and an alert when the displayed SpO2 values are not based on adequate signal

quality. The signal quality indicator displayed on the Radical-7R Pulse CO-Oximeter is called

the SpO2 SIQ. The SpO2 SIQ can be used to identify the occurrence of a patient’s pulse and

the associated signal quality of the measurement.

With motion, the plethysmographic waveform is often distorted and may be obscured by

artifact. Even with a plethysmographic waveform obscured by artifact, the Radical-7R Pulse

CO-Oximeter locates the arterial pulsation.

When the signal quality is very low the accuracy of the SpO2 measurement may be

compromised, and a Low SpO2 SIQ message is displayed in the message area on the

Radical-7R Pulse CO-Oximeter display. When the Low SPO2 SIQ message appears, proceed

with caution and do the following:

■ Assess the patient.

■ Check the sensor and ensure proper sensor application. The sensor must be well secured

to the site for the Radical-7R Pulse CO-Oximeter to maintain accurate readings. Also,

misalignment of the sensor’s emitter and detector can result in smaller signals and cause

erroneous readings.

■ Determine if an extreme change in the patient’s physiology and blood flow at the monitoring

site occurred, (e.g. an inflated blood pressure cuff, a squeezing motion, sampling of an

arterial blood specimen from the hand containing the pulse oximetry sensor, severe

hypotension, peripheral vasoconstriction in response to hypothermia, medications, or an

episode of Raynaud’s syndrome.)

■ With neonates or infants, check that the peripheral blood flow to the sensor site is not

interrupted. Interruption, for example, may occur while lifting or crossing their legs during

a diaper change.

After performing the above, if the Low SpO2 SIQ message is displayed frequently or

continuously, obtaining an arterial blood specimen for CO-Oximetry analysis may be considered

to verify the oxygen saturation value.

Low SpCO SIQ and Low SpMet SIQ

When the signal quality for SpCO and/or SpMet is very low the accuracy of the SpCO and/or

SpMet measurement(s) may be compromised, and a Low SpCO SIQ and/or Low SpMet SIQ

message is displayed in the message area on the Radical-7R Pulse CO-Oximeter display. When

the Low message(s) appear, proceed with caution and follow the steps listed in Section 4, Signal

Indication and Quality Indicator (SiQ).

Low SpHb SIQ

When the SpHb signal quality is very low, the accuracy of the SpHb measurement may be

compromised. A Low SpHb SIQ message is displayed in the message area on the Radical-7R

Pulse CO-Oximeter display, and the parameter/measurement value will display dashes (“---”)

instead of a number value for SpOC and SpHct.

Operation

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

Operation

SIGNAL INDICATION AND QUALITY INDICATOR - ACOUSTIC (SIQa)

SIQa displays the confidence level of the measured signal. A high confidence level

displays as a high percentage. When the SIQa is high and the parameter label flash-

es, there may be interference from excessive ambient or environmental noise. A low

confidence level displays as a low percentage. A very small signal, with a red bar, may

indicate that the acuracy of the respiration rate measurement may be compromised.

Whenever the parameter label flashes, proceed with caution and do the following:

■ Assess the patient.

■

Check the Acoustic Respiration sensor and ensure proper sensor application.

■

The Acoustic Respiration sensor and ensure proper application. The Acoustic

Respiration sensor must be well secured to the site for the Radical-7R to

maintain accurate readings. Refer to the Acoustic Respiration sensor's

Directions for Use for proper sensor placement.

■ Identify and remove excessive ambient or environmental noise sources affect-

ing the Acoustic Respiration value.

RESPIRATION INDICATOR (RI)

The Respiration Indicator (RI) displays the sound level of the measured signal. A high

sound level displays as a tall signal. A low sound level displays as a small signal. When

the signal quality is very small the accuracy of the respiration rate measurement may be

compromised. When the RI is small, the bar turns red and the parameter label flashes.

Proceed with caution and do the following:

■ Assess the patient.

■ Check the Acoustic Respiration sensor and ensure proper sensor application. The

Acoustic Respiration sensor must be well secured to the site for the Radical-7R to

maintain accurate readings. Refer to the Acoustic Respiration sensor's Directions

for Use for proper sensor placement.

ACOUSTIC RESPIRATION SENSOR PLACEMENT

■ Only use on adult patients weighing > 30 kg.

■ The preferred measuring site is to either side of the larynx, in the area just above

the thyroid cartilage and below the jaw line. Refer to the Acoustic Respiration sen-

sor's Directions for Use for proper sensor placement.

■ Site should be hair-free, cleaned of debris and dry prior to sensor placement. Use

an alcohol swab to clean the neck area, if needed.

■ Ensure that the Acoustic Respiration sensor, Acoustic Respiration Patient Cable

and Dual Rainbow Cable are all securely connected.

NOTE: When the Acoustic Respiration Sensor is off the patient and is connected

to the system the sensor may pick up periodic ambient sounds and

report a measurement. The sensor should only be connected to the

Acoustic Respiration Patient Cable while performing patient monitoring. If

the patient is not being monitored, the sensor should be disconnected from

the Acoustic Respiration Patient Cable.

4-8 Radical-7R Pulse CO-Oximeter Operator’s Manual

NUMERIC DISPLAY - (PI)

The perfusion index (PI) display provides a relative numeric indication of the pulse strength at

the monitoring site. It is a calculated percentage of the pulsatile signal to non-pulsatile signal

of arterial blood moving through the site. PI may be used to find the best perfused site and to

monitor physiological changes in the patient. It displays an operating range of 0.01 percent

to 20.00 percent. A percentage greater than 1.00 percent is desired. Extreme changes in the

display number are due to motion artifact and changes in physiology and blood flow. The PI

measurement is displayed as follows:

≤ 0.99 (2 decimal places)

1.0 to 9.9 (1 decimal place)

≥10 (0 decimal places)

PLETH VARIABILITY INDEX - (PVI)

The pleth variability index (PVI) is a measure of the dynamic changes in the perfusion index

(PI) that occur during the respiratory cycle. The calculation is accomplished by measuring

changes in PI over a time interval where one or more complete respiratory cycles have

occurred. PVI is displayed as a percentage (0-100%).

LOW PERFUSION

The Radical-7R Pulse CO-Oximeter displays a “Low PI” message when there are very low

amplitude arterial pulsations.

It has been suggested that at extremely low perfusion levels, pulse oximeters can measure

peripheral saturation, which may differ from central arterial saturation3. This “localized

hypoxemia” may result from the metabolic demands of other tissues extracting oxygen proximal

to the monitoring site under conditions of sustained peripheral hypoperfusion. (This may occur

even with a pulse rate that correlates with the ECG heart rate.)

CAUTION: IF THE LOW PI MESSAGE IS FREQUENTLY DISPLAYED, FIND A BETTER-

PERFUSED MONITORING SITE. IN THE INTERIM, ASSESS THE PATIENT

AND, IF INDICATED, VERIFY OXYGENATION STATUS THROUGH OTHER

MEANS.

3 Severinghaus JW, Spellman MJ. Pulse Oximeter Failure Thresholds in Hypotension and Vasoconstriction. Anesthesiology 1990; 73:532-537

ACTIONS TO BE TAKEN

If the SpO2, SpCO, SpMet, SpHb, SpOC, SpHct, PVI, PI or pulse rate readings show significant

differences, do the following:

■ Make sure the emitter and detector are aligned directly opposite each other.

■ Select a site where the distance between the emitter and detector is minimized.

■ Wipe the sensor site with a 70% isopropyl alcohol pad or rubefacient cream (10-30% methyl

salicylate and 2-10% menthol) for 20-30 seconds to increase perfusion. However, strong

vasodilator creams, such as nitroglycerin paste, are not recommended.

■ If possible, remove electrical noise sources such as electrosurgical units or other electrical/

electronic equipment. If these solutions are not possible, operate the Pulse CO-Oximeter on

battery power, or try plugging the Pulse CO-Oximeter into a different electrical outlet.

■

If artificial nails or excessive fingernail polish are present, select another site or remove the

polish/artificial nails.

■ If possible, ensure that the sensor is placed in a location with low ambient or low strobing

light. Although the Radical-7R with integrated Masimo Rainbow SET technology has

Operation

Radical-7R Pulse CO-Oximeter Operator’s Manual 4-9

Operation

significant immunity to ambient or strobing light, excessive ambient or excessive strobing

light may cause readings to be incorrect.

CAUTION: IF ANY MEASUREMENT SEEMS QUESTIONABLE, FIRST CHECK THE

PATIENT’S VITAL SIGNS BY ALTERNATE MEANS AND THEN CHECK THE

PULSE CO-OXIMETER FOR PROPER FUNCTIONING.

SENSITIVITY

Three sensitivity levels enable a clinician to tailor the response of the Radical-7R to the needs

of the particular patient situation. They are as follows:

■ Normal Sensitivity – This is the recommended mode for patients that are experiencing

some compromise in blood flow or perfusion. It is advisable for care areas where patients

are observed frequently, such as an intensive care unit (ICU).

■

Adaptive Probe Off Detection (APOD) – This is the recommended monitoring mode where there

is a high probability of the sensor becoming detached. It is also the suggested mode for care

areas where patients are not visually monitored continuously. This mode delivers enhanced

protection against erroneous pulse rate and arterial oxygen saturation readings when a sensor

becomes inadvertently detached from a patient due to excessive movement.

■ Maximum Sensitivity (MAX) - This mode is recommended for patients with low perfusion or

when the low perfusion message is displayed on the screen in APOD or normal sensitivity

mode. This mode is not recommended for care areas where patients are not monitored

visually, such as general wards. It is designed to interpret and display data at the measuring

site when the signal may be weak due to decreased perfusion. When a sensor becomes

detached from a patient, it will have compromised protection against erroneous pulse rate

and arterial saturation readings.

CAUTION: WHEN USING THE MAXIMUM SENSITIVITY SETTING, PERFORMANCE

OF THE SENSOR OFF DETECTION MAY BE COMPROMISED. IF THE

INSTRUMENT IS IN THIS SETTING AND THE SENSOR BECOMES

DISLODGED FROM THE PATIENT, THE POTENTIAL FOR FALSE READINGS

MAY OCCUR DUE TO ENVIRONMENTAL ‘NOISE’ SUCH AS LIGHT, VIBRATION

AND EXCESSIVE AIR MOVEMENT.

4-10 Radical-7R Pulse CO-Oximeter Operator’s Manual

Touch Key Control Buttons and Icons

On the Radical-7R Pulse CO-Oximeter display, four icons are shown on the right side of the LCD display.

These icons can be selected either by using the touch key control buttons or the touchscreen.

The touch key control buttons are the four dark grey control buttons to the right of the Handheld

display. To select an icon, press and release the touch key control button to the right of the icon,

or touch it on the touchscreen.

Traditional User Interface

CHANGE

LAYOUT

The change layout function is on button 1 when a menu is not up. It

allows the user to change the main layout between the one with the

SIQa and Respiration indicators.

MENU ACCESS Press to enter the main menu.

SENSITIVITY

Press to toggle between the Normal, APOD and Maximum

Sensitivity modes. Use the Normal Sensitivity setting for typical

monitoring purposes. Use the APOD setting where there is a high

probability of the sensor becoming detached. Use the Maximum

Sensitivity setting for patients with low perfusion or when the low

perfusion message is displayed on the screen in APOD or normal

sensitivity mode. The default mode is APOD.

CAUTION: WHEN USING THE MAXIMUM SENSITIVITY SETTING,

THE PERFORMANCE OF THE SENSOR OFF

DETECTION MAY BE COMPROMISED.

NOTE: In “Custom” mode the instrument will remain in Normal

or APOD setting after a power cycle. Maximum Sensitivity will

automatically reset to Normal Sensitivity after a power cycle.

In “Neo” or “Adult” mode the instrument will reset the sensitivity to the

hospital specified setting (Normal or APOD) after a power cycle.

Operation

Radical-7R Pulse CO-Oximeter Operator’s Manual 4-11

Operation

Navigating the Main Menu

When the main menu is accessed, the plethysmographic and Signal IQ waveform displays are

replaced with the main menu items. The touch key icons, displayed along the right edge of the LCD

display, are also replaced by the menu access icons. When the main menu is accessed, the monitor

remains functional and the saturation and pulse rate numbers will continue to be displayed.

MAIN MENU SELECTION

The top menu category uses the following four menu selections and touch key control buttons and icons.

EXIT Select the Exit icon to exit the main menu.

SELECT

CATEGORY

Select the Select Category icon to select the highlighted menu

item and enter the next level menu.

Select the Previous icon to scroll through the menu items without

selecting them. Once a menu item is highlighted, enter the menu

by pressing the Select Category icon.

Select the Previous icon to scroll through the menu items without

selecting them. Once a menu item is highlighted, enter the menu

by pressing the Select Category icon.

MENU CATEGORIES

Once a menu category has been selected, a new set of menu selections and icons are displayed.

EXIT Select the Exit icon to exit the menu category and return to the

main monitoring screen.

EDIT

PARAMETER

Select the Edit Parameter icon to select the highlighted

parameter/measurement for editing.

Select the Previous icon to scroll through the parameters/

measurements. Once a parameter/measurement is highlighted, edit

the parameter/measurement by pressing the Edit Parameter icon.

Select the Next icon to scroll through the parameters/measurements.

Once a parameter/measurement is highlighted, edit the parameter/

measurement by pressing the Edit Parameter icon.

EDITING A PARAMETER/MEASUREMENT

Once a parameter/measurement has been selected for editing, a new set of menu

selections and icons are displayed.

EXIT Select the Exit icon to exit the parameter/measurement without

making the new selections permanent.

ACCEPT Select the Accept icon to save the changes.

PREVIOUS Select the Previous icon to increase or toggle the parameter/

measurement settings.

NEXT Select the Next icon to decrease or toggle the parameter/

measurement settings.

4-12 Radical-7R Pulse CO-Oximeter Operator’s Manual

4Operation

MENU TREE

MAIN MENU

ALARM LIMITS MENU

Radical-7R Pulse CO-Oximeter Operator’s Manual 4-13

Operation

ABOUT MENU

GENERAL MENU

CONFIGURATION MENU

4-14 Radical-7R Pulse CO-Oximeter Operator’s Manual

AVERAGING MENU

OUTPUT MENU

FACTORY DEFAULTS MENU

Operation

Radical-7R Pulse CO-Oximeter Operator’s Manual 4-15

Operation

Alarms

Check alarm limits each time the Pulse CO-Oximeter is used to ensure that they are appropriate for the

patient being monitored. An audible alarm and a flashing alarm icon (and indicator light) will occur when an

alarm limit is exceeded. It is best that the operator be within a minimum of 10 feet from the instrument.

MENU ITEMS DESCRIPTION

SpO2 HIGH LIMIT

The SpO2 high alarm limit can be set anywhere between 2% and 99%, then “---”

with a 1% step size. In the “----” (off) setting, the alarm can be turned off completely.

SpO2 LOW LIMIT

The SpO2 low alarm limit can be set anywhere between 1% and 98%, with a 1% step size.

NOTE: The low alarm limit must be set below the high alarm setting. When the high alarm limit

is set below the low alarm limit, the low alarm limit will automatically adjust to the next setting

below the newly entered high alarm limit setting.

NOTE: The SpO2 low limit cannot be set below the password protected minimum low

SpO2 alarm limit. See Section 4, Operation, Display for details.

PULSE RATE HIGH

LIMIT (BPM)

The pulse rate high alarm limit can be set anywhere between

35 BPM and 235 BPM, with a 5 BPM step size.

PULSE RATE LOW

LIMIT (BPM)

The pulse rate low alarm limit can be set anywhere between 30 BPM

and 230 BPM, with a 5 BPM step size.

NOTE: The low alarm limit must be set below the high alarm setting. When the high alarm limit

is set below the low alarm limit, the low alarm limit will automatically adjust to the next setting

below the newly entered high alarm limit setting.

SpMet HIGH LIMIT The SpMet high alarm limit can be set anywhere between 1.0% to

99.5%, then “---”. with a step increment of 0.1%.

SpMet LOW LIMIT

The SpMet low alarm limit can be set as “---”, or anywhere between

0.1% to 99% with a step increment of 0.1%. In the “----” (off) setting, the

alarm can be turned off completely.

NOTE: The low alarm limit must be set below the high alarm setting. If the high alarm limit

is set below the low alarm limit, the low alarm limit will automatically adjust to the next

setting below the newly entered high alarm limit setting.

SpCO HIGH LIMIT The SpCO high alarm limit can be set anywhere between 2% and 98%,

then “---” with a 1% step size.

SpCO LOW LIMIT

The SpCO low alarm limit can be set as “---”, or anywhere between 1% and 97%,

with a 1% step size. In the “----” (off) setting, the alarm can be turned off completely.

NOTE: The low alarm limit must be set below the high alarm setting. If the high alarm limit is

set below the low alarm limit, the low alarm limit will automatically adjust to the next setting

below the newly entered high alarm limit setting.

SpHb HIGH LIMIT

The SpHb high alarm limit can be set anywhere between 2.0 g/dl and 24.5

g/dl, then “---” with a 0.1 g/dl step size. In the “---” (off) setting, the SpHb

High Alarm Limit Alarm is disabled. Factory default setting is 17 g/dl.

SpHb LOW LIMIT

The SpHb low alarm limit can be set as “---”, or anywhere between 1.0 g/

dl and 24 g/dl with a 0.1 g/dl step size. In the “---” (off) setting, the SpHb

Low Alarm Limit Alarm is disabled. Factory default setting is 7 g/dl.

NOTE: The low alarm limit must be set below the high alarm setting. If the high

alarm limit is set below the low alarm limit, the low alarm limit will automatically

adjust to the next setting below the newly entered high alarm limit setting.

4-16 Radical-7R Pulse CO-Oximeter Operator’s Manual

4Operation

MENU ITEMS DESCRIPTION

PI HIGH LIMIT

The PI high alarm limit can be set anywhere between 0.04 and 19, then “---”

with a 0.01 step size between 0.04 and 0.10, a 0.10 step size between 0.10

and 1.0, and a 1.0 step size between 1.0 and 19. In the “---” (off) setting,

the PI High Alarm Limit Alarm is disabled. Factory default setting is “---” (off)

PI LOW LIMIT

The PI low alarm limit can be set as “---”, or anywhere between 0.03 to

18 with a .01 step size. In the “---” (off) setting, the PI Low Alarm Limit

Alarm is disabled. Factory default setting is “---” (off).

NOTE: The low alarm limit must be set below the high alarm setting. If the high alarm limit

is set below the low alarm limit, the low alarm limit will automatically adjust to the next

setting below the newly entered high alarm limit setting.

PVI HIGH LIMIT

The PVI high alarm limit can be set anywhere between 2 and 99, then

“---” with a 1 step size between 2 and 99. In the “---” (off) setting, the PVI

High Alarm Limit Alarm is disabled. Factory default setting is “---” (off).

PVI LOW LIMIT

The PVI low alarm limit can be set as “---”, or anywhere between 1 and

98 with a 1 step size. In the “---” (off) setting, the PVI Low Alarm Limit

Alarm is disabled. Factory default setting is “---” (off).

NOTE: The low alarm limit must be set below the high alarm setting. If the high alarm

limit is set below the low alarm limit, the low alarm limit will automatically adjust to the next

setting below the newly entered high alarm limit setting.

RRa HIGH LIMIT The respiration rate high alarm limit can be set anywhere between

5 to 69 breaths per minute., with a 1 step size.

RRa LOW LIMIT

The respiration rate low alarm limit can be set anywhere between 4 to

68 breaths per minute, with a 1 step size.

In the “----” (off) setting, the alarm

can be turned off completely.

NOTE: The low alarm limit must be set below the high alarm setting. When the high alarm limit

is set below the low alarm limit, the low alarm limit will automatically adjust to the next setting

below the newly entered high alarm limit setting.

DELAY

This menu allows the users to set an audible saturation delay. The delay

can be set to either 0, 5,10 or 15 seconds. The delay setting only affects

saturation alarms indications.

Radical-7R Pulse CO-Oximeter Operator’s Manual 4-17

General

MENU ITEMS DESCRIPTION

FASTSAT

Select Yes to activate the FastSat algorithm. In the 2 and 4 seconds

averaging mode, the FastSat algorithm is automatically enabled.

SMART TONE

Select Ye s to activate the SmartTone function. This will allow the audible pulse to

continue to beep when the pleth graph shows signs of motion. Select NO to turn

off SmartTone.

PULSE TONE

Select YES to activate the Pulse Tone function. This will allow the audible

pulse to continue to beep upon each patient pulsation..

About

This displays the copyright and software versions of the Handheld and Docking Station.

MENU ITEMS

Masimo Corporation

Masimo SET Software Version

Handheld Software Version

D-Station Software Version

Configuration

MENU ITEMS DESCRIPTION

Line Frequency

Set to 50 or 60Hz.

Set to match regional power line frequency to allow for

cancellation of noise introduced by ﬂ uorescent lights and other

sources. Factory default is 60 Hz.

Rapid Desat Limit

Set to Off, -5 or -10.

When set to -5%, this feature overrides the Alarm Delay (audible

alarms silenced) and the instrument will alarm if SpO2 rapidly falls to

5% or 10% below the alarm limit. Factory default is -5%

SpHb Cal

Set to Arterial or Venous.

This feature provides an SpHb (Arterial) or SpHbV (Venous)

value that displays on the main screen.

NOTE: The hemorheologic proﬁ le of arterial and venous blood

samples can vary1. To accommodate this difference, the

Radical-7R provides the option of displaying a SpHb parameter

that is based on either Arterial or Venous SpHb laboratory

blood sample draw.

Changes to SpHb are included in output data. SpOC

calculation will always be based on the arterial SpHb.

Operation

4-18 Radical-7R Pulse CO-Oximeter Operator’s Manual

4Operation

Output

NOTE: The output menu selections are only available when the Radical -7 Handheld is

interfaced to the Docking Station.

MENU ITEMS DESCRIPTION

NURSE CALL

ALARMS

The nurse call output will be activated based on alarm

events.

LOW SIGNAL IQ

The nurse call output will be activated based on Low

Signal IQ events.

ALARM & SIGNAL IQ

The nurse call ouput will be activated based on alarm and

Low Signal IQ events.

POLARITY

NORMAL

Standard polarity. See Section 7, Nurse Call speciﬁ cations.

INVERT

This setting reverses the Normally Open and Normally

Closed contacts. See Section 7, Nurse Call speciﬁ cations.

CAUTION: TO AVOID EXCESSIVE BATTERY DISCHARGING, DO NOT CONNECT

ANY EQUIPMENT TO THE SERIAL PORT ON THE BACK PANEL UNLESS

THE RADICAL-7R IS CONNECTED TO THE AC POWER FROM THE WALL

OUTLET.

Radical-7R Pulse CO-Oximeter Operator’s Manual 4-19

SatShare Operation

When the SatShare cable is connected to the Radical-7R Pulse CO-Oximeter and to a

multiparameter patient monitor, the Radical-7R Pulse CO-Oximeter automatically starts to

operate in the SatShare mode.

In the SatShare mode, Radical-7R Pulse CO-Oximeter operates as follows:

■ All visual alarms remain active.

■ All audible alarms may be disabled by software configuration of the Radical-7R Pulse

CO-Oximeter. Refer to Section 4, Alarms.

■ The SpO2 and pulse rate numbers may or may not be displayed on the Radical-7R

Pulse CO-Oximeter display depending on the SatShare Numbers setting of the

General menu. Refer to Section 3, SatShare Setup.

■ All other items are displayed, including the alarm limits, the plethysmogram and Signal

IQ waveform.

■ The user can access the menu system.

■ If the SatShare cable is connected to the Radical-7R Pulse CO-Oximeter only, and not

to a patient monitor, the SatShare cable type is flashing on the LCD screen.

■ Once the Radical-7R Pulse CO-Oximeter detects the presence of a patient monitor,

the SatShare cable type remains constantly displayed on the LCD screen.

■ Patient Alarms of the multiparameter patient monitor will be triggered by the

alarm setting of the patient monitor and not the Radical-7 Pulse CO-Oximeter. To

synchronize the alarm events set the alarm limits of the Radical-7 Pulse CO-Oximeter

to those of the patient monitor, or vice versa.

■ Once the Radical-7R Pulse CO-Oximeter detects that the SatShare cable is

disconnected from the patient monitor, or if the patient monitor is turned off, the

Radical-7R automatically returns to normal, standalone operation.

■ In the SatShare mode, the pulse beep tone of the Radical-7R Pulse CO-Oximeter

is initially set to the lowest volume (mute). The pulse beep volume can be manually

increased. Refer to Section 4, Traditional User Interface.

■ The Radical-7R Pulse CO-Oximeter may automatically set the averaging time during

SatShare operation. For averaging times of 10 seconds and higher, the Radical-7

Pulse CO-Oximeter will automatically set the averaging time to 8 seconds during

SatShare operation. Averaging times of 2, 4 or 8 seconds remain unchanged during

SatShare operation. When the Radical-7R Pulse CO-Oximeter returns to non-

SatShare operation, the Radical-7 Pulse CO-Oximeter will maintain the averaging

time setting used in the SatShare mode.

■ When the Radical-7R Pulse CO-Oximeter starts to operate in the SatShare mode the

sensitivity mode is set to Normal sensitivity. The sensitivity mode can manually be set

to Maximum or APOD sensitivity. Refer to Section 2, Handheld Front Panel.

Operation

4-20 Radical-7R Pulse CO-Oximeter Operator’s Manual

SatShare Operation (continued)

■ While operating in the SatShare mode, the Radical-7R Pulse CO-Oximeter may

automatically disable the SatShare interface if the perfusion index drops below 0.1%

while the sensitivity is set to Max sensitivity. To enable the SatShare interface again,

set the Radical-7R Pulse CO-Oximeter to the Normal or APOD sensitivity mode,

increase the perfusion at the measurement site (by warming the patient or sensor

site), or move the sensor to a site with better perfusion.

CAUTIONS:

■ SATSHARE SIGNALS ARE IDEAL SIMULATED WAVEFORMS CORRESPONDING

TO THE CALCULATED SATURATION AND PULSE RATE VALUES AND DO

NOT CONTAIN ALL OF THE INFORMATION CONTAINED IN PHYSIOLOGICAL

WAVEFORMS. THE MULTIPARAMETER PATIENT MONITOR DECODES THESE

SIGNALS INTO SATURATION AND PULSE RATE VALUES.

■ DURING SATSHARE OPERATION, THE AUDIBLE ALARMS MAY BE MUTED

ON THE RADICAL-7R PULSE CO-OXIMETER. WHEN THE AUDIBLE ALARM

IS MUTED (INDICATED BY A BELL WITH A SLASH THROUGH IT) ON THE

RADICAL-7 PULSE CO-OXIMETER, USE THE MULTIPARAMETER MONITOR FOR

AUDIBLE ALARM INDICATION.

■ THE (RADICAL-7R) SpO2 AND PULSE RATE AUDIBLE ALARMS MAY BE

DISABLED WHEN THE RADICAL-7R IS CONFIGURED WITH RAINBOW

PARAMETERS/MEASUREMENTS. REFER TO SECTION 4 ALARMS.

■ THE RADICAL-7R REVERTS TO THE INTERFACE ALARM "SpO2/BPM" “Yes”

SETTING DURING POWER INTERRUPTIONS OR WHEN THE SATSHARE

CONNECTION IS LOST OR THE DEVICE BECOMES SEPARATED FROM THE

DOCKING STATION. THIS ENSURES THAT THE RADICAL-7R PROVIDES

AUDIBLE ALARMS FOR SpO2 AND PULSE RATE WHEN THE CONNECTION TO

THE INTERFACED SYSTEM BECOMES COMPROMISED.

■ DURING SATSHARE OPERATION DO NOT USE THE PLETHYSMOGRAPHIC

WAVEFORM DISPLAY ON THE MULTIPARAMETER MONITOR FOR DIAGNOSTIC

PURPOSES. INSTEAD, USE THE PLETHYSMOGRAPHIC WAVEFORM DISPLAYED

ON THE RADICAL-7R SCREEN.

■ TO AVOID EXCESSIVE BATTERY DISCHARGING, DO NOT CONNECT ANY

EQUIPMENT TO THE SATSHARE CONNECTOR UNLESS THE RADICAL-7R IS

CONNECTED TO THE AC MAINS POWER SUPPLY.

■ ONLY USE A SATSHARE CABLE THAT HAS A FERRITE BEAD INSTALLED.

■ ONLY SPO2 AND PULSE RATE CAN BE DISPLAYED ON THE MULTIPARAMETER

MONITOR WITH SATSHARE.

To return from SatShare operation to normal standalone operation, simply disconnect

the SatShare cable from the patient monitor or disconnect the SatShare cable from the

SatShare connector on the back of the Radical-7R Pulse CO-Oximeter.

Operation

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

Alarm Identification

The Radical-7R visually and audibly indicates alarm conditions that the system detects. Audible

alarms may be silenced, without affecting the operation of visual alarms.

Three levels of alarm priority are implemented: high, medium and low priority. The following table

outlines the alarm priority specifications.

ALARM

PRIORITY

PARAMETER/MEASUREMENT —

ALARM SETTING RANGE ALARM TYPE

High

Low arterial oxygen saturation

Audible and

visual

High carboxyhemoglobin saturation

High methemoglobin saturation

Low total hemoglobin

High total hemoglobin

Low pulse rate

High pulse rate

Low respiration rate

High respiration rate

Sensor off and no sensor

Defective Sensor

Defective patient cable

System failures

Medium

High saturation

Audible and

visual

Low PI

High PI

Low PVI

High PVI

Low carboxyhemoglobin saturation

Low methemoglobin saturation

Low Low battery, monitoring patient Audible and

Visual

NOTE: There are no alarms associated with SpOC or SpHct.

Alarms and Messages

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

5Alarms and Messages

System Messages

The following chart alphabetically lists all system messages displayed on the LCD screen. The

cause of the message, and the action(s) to be taken are also shown.

The operator should become thoroughly familiar with this information before using the Pulse

CO-Oximeter for patient monitoring.

MESSAGE POSSIBLE CAUSE RECOMMENDATION

REPLACE

SENSOR

SpHb reusable sensor has used all

of its available monitoring time.

Sensor is non-functional.

Replace sensor.

REPLACE

CABLE

Pulse CO-Oximeter cannot identify

the connected cable or the cable

has failed.

Inoperative or faulty cable; Replace

cable. Refer to the Directions for

Use of the cable being used.

REPLACE SENSOR Defective sensor. Replace sensor.

INCOMPATIBLE

SENSOR

Not a proper Masimo sensor. Replace with a proper Masimo

sensor. Refer to Section 8.

SpHb sensor is attached to a

instrument without SpHb installed.

Use a non-SpHb sensor.

Contact your local Masimo

Representative to learn more

about the optional SpHb upgrade.

REPLACE

SENSOR

Pulse CO-Oximeter cannot identify

the connected sensor.

Broken sensor cable wire or

inoperative LEDs or faulty

detector; the sensor has failed.

Replace sensor. Refer to the

instructions for the sensor being

used.

Not a compatible Masimo sensor. Replace with a proper Masimo

sensor. Refer to Section 8.

SpHb sensor is attached to a

instrument without SpHb installed.

Use a non-SpHb sensor.

Contact your local Masimo

Representative to learn more

about the optional SpHb upgrade.

NO ADHESIVE

When a single patient use sensor

is used, the adhesive portion

of the sensor is not connected.

(Applies to Rainbow ReSposable

CO-Oximeter Sensor Systems, or

ReSposable Pulse Oximeter Sen-

sor Systems only)

Ensure the adhesive portion is

ﬁ rmly connected to the sensor.

REPLACE

ADHESIVE

When a single patient use sensor

is used, the adhesive portion

of the sensor is incompatible or

unrecognized. (Applies to Rainbow

ReSposable CO-Oximeter Sensor

Systems, or ReSposable Pulse

Oximeter Sensor Systems only)

Correct the correct adhesive por-

tion of the sensor.

Radical-7R Pulse CO-Oximeter Operator’s Manual 5-3

MESSAGE POSSIBLE CAUSE RECOMMENDATION

REPLACE

ADHESIVE

When a single patient use sensor

is used, the adhesive portion of the

sensor is non-functional, or the life

of the adhesive portion of the sen-

sor has expired. (Applies to Rainbow

ReSposable CO-Oximeter Sensor

Systems, or ReSposable Pulse

Oximeter Sensor Systems only)

Replace the adhesive portion of

the sensor.

LOW

BATTERY Battery charge is low.

Charge battery by placing the

Radical-7R Handheld into the

Docking Station and powering the

instrument with AC line power.

Replace battery if necessary.

LOW

PERFUSION Signal too small.

Move sensor to better perfused site.

Refer to Section 4, Low Perfusion.

REPLACE

REUSABLE

The reusable sensor (i.e., the

durable portion that includes

the emitter and detector) is

non-functional, or the life of the

reusable sensor has expired.

(Applies to Rainbow ReSposable

CO-Oximeter Sensor Systems,

or ReSposable Pulse Oximeter

Sensor Systems only)

Replace the reusable sensor.

REPLACE CABLE

The patient cable is non-

functional, or the life of the cable

has expired.

Replace the patient cable.

INTERFERENCE

High intensity light such as

pulsating strobe lilghts, excessive

ambient light sources such as

surgical lights or direct sunlight, or

other monitor displays.

Place a Masimo Optical Light

Shield over the sensor.

Incorrect monitor light frequency (Hz)

Access the Traditional User

Interface described in Section

4. Select Conﬁ g and enter

the password. Adjust the LIne

Frequency to the correct Hz setting.

CHECK SENSOR

Sensor is not connected ﬁ rmly into

patient cable, or the sensor is not

connected ﬁ rmly to the instrument.

Reconnect sensor ﬁ rmly into

patient cable or to the instrument.

SPO2 ONLY MODE

"SpO2 Only Mode" message

occurs during an unsucessful

sensor calibration/pulse search

routine, or during monitoring.

Review the sensor's Directions

for Use instructions, Section

4, Sucessful Monitoring, and

Section 8, Selecting a Masimo

SET Sensor.

Alarms and Messages

System Messages (continued)

5-4 Radical-7R Pulse CO-Oximeter Operator’s Manual

5Alarms and Messages

System Messages (continued)

MESSAGE POSSIBLE CAUSE(S) RECOMMENDATION

LOW SIGNAL IQ Low signal quality.

Ensure proper sensor application. Move

sensor to a better perfused site. Refer to

Section 4, Signal IQ.

LOW SpCO SIQ SpCO measurement

reading is obscured.

Ensure proper sensor application. Check sensor

to see if it is working properly. If not, replace the

sensor. Refer to Section 4, Numeric Display -

SpCO.

LOW SpMet SIQ SpMet measurement

reading is obscured.

Ensure proper sensor application. Check

sensor to see if it is working properly. If

not, replace the sensor. Refer to Section 4,

Numeric Display - SpMet.

LOW SpHb SIQ SpHb measurement

reading is obscured.

Ensure proper sensor application. Check

sensor to see if it is working properly. If

not, replace the sensor. Refer to Section 4,

Numeric Display - SpHb.

NO CABLE

Cable not attached or

not fully inserted into the

connector

Disconnect and reconnect cable into connector.

NO SENSOR

Sensor not fully inserted

into the connector.

May be an incorrect sensor, or a defective

sensor or cable. Insert sensor into

connector. Disconnect and reconnect

sensor. Refer to the instructions for the

sensor being used.

Instrument is searching for

patient’s pulse.

Disconnect and reconnect the sensor into

the Patient Cable Connector.

PULSE SEARCH Instrument is searching

for patient’s pulse.

If values are not displayed within 30

seconds, disconnect and reconnect sensor.

If pulse search continues, remove sensor

and replace on a better perfused site.

SENSOR

CALIBRATING

Instrument is checking

the sensor for proper

functioning and

performance.

If values are not displayed within 30

seconds, disconnect and reconnect sensor.

If values are still not displayed, replace with

a new sensor.

SENSOR OFF Sensor off patient. Disconnect and reconnect sensor.

Reattach sensor.

REPLACE CABLE Not a proper cable. Replace with a proper cable. Refer to

Section 8.

NO AC CABLE AC Cable not detected.

May be an incorrect cable, or a defective

cable. Disconnect and reconnect the cable.

Refer to instructions for the cable being used

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

5-5

Alarms and Messages

MESSAGE POSSIBLE CAUSE(S) RECOMMENDATION

INCOMPATIBLE AC

CABLE Not a compatible cable. Replace with a proper cable. Refer to

Section 8.

REPLACE AC

CABLE

Pulse CO-Oximeter

cannot identify the

connected cable or the

cable has failed.

Inoperative or faulty cable; Replace cable.

Refer to the Directions for Use of the cable

being used.

REPLACE AC

CABLE Not a proper AC cable. Replace with proper AC cable. Refer to

Section 8.

NO AC SENSOR Sensor not fully inserted

into the connector.

May be an incorrect sensor, or a defective

sensor or cable. Insert sensor into

connector. Disconnect and reconnect

sensor. Refer to the instructions for the

sensor being used.

INCOMPATIBLE AC

SENSOR

Not a proper Masimo sensor.

Replace with a proper Masimo sensor. Refer

to Section 8.

REPLACE AC

SENSOR

Pulse CO-Oximeter

cannot identify the

connected AC sensor or

the sensor has failed.

Inoperative or faulty AC sensor; Replace

sensor. Refer to the Directions for Use of the

sensor being used.

AC SENSOR Not a proper AC sensor.

Replace with proper AC sensor. Refer to Section 8.

AC SENSOR OFF

AC sensor not connected

to patient properly.

Sensor is damaged.

Properly reapply the AC sensor on the

patient and reconnect the sensor to the

instrument or patient cable.

If the sensor is damaged, replace the sensor.

System Messages (continued)

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

Troubleshooting

The following chart describes what to do if the Radical-7R Pulse CO-Oximeter system

does not operate properly or fails.

PROBLEM POSSIBLE

CAUSE(S) RECOMMENDATION

INSTRUMENT DOES

NOT POWER ON

One or both of the fuses

are not operating properly. Replace the fuses.

INSTRUMENT POWERS

ON BUT THE GRAPHIC

DISPLAY IS BLANK

The viewing contrast is

not correct.

Instrument requires service.

CONTINUOUS SPEAKER

TONE

Internal failure.

Instrument requires service. Press the

Alarm Silence button to silence the

alarm. If alarm continues to sound,

power down instrument and remove

Handheld battery if necessary.

BUTTONS DON’T WORK

WHEN PRESSED Internal failure. Instrument requires service.

DEFECTIVE SENSOR

MESSAGE Sensor or cable is broken.

Visually check the sensor LED if it is

flashing on and off.

If not, reconnect the cable and check

the LED again.

If the LED still fails to come on,

replace the sensor and/or cable.

SpO2 NUMBER FLASHES Saturation alarm limit

exceeded.

Assess/address patient condition.

Re-set alarm limits if indicated.

SENSOR OFF MESSAGE

Sensor not connected to

patient properly.

Sensor is damaged.

Properly reapply the sensor on the

patient and reconnect the sensor to

the instrument or patient cable.

If the sensor is damaged, replace the sensor.

NO SENSOR MESSAGE

Sensor is disconnected

from patient cable.

Sensor connected upside

down into patient cable.

Check to see if the sensor LED is

flashing. Disconnect and reconnect

the sensor. If the LED fails to operate,

replace the sensor.

LOW PERFUSION

Improper sensor type.

Poorly perfused site.

Sensor is too tight.

A disorder such

as hypothermia,

vasoconstriction,

hypovolemia, peripheral

vascular disease or anemia.

Sensor is damaged.

Verify proper sensor and sensor size

for the patient.

Check and see if blood flow to the site

is restricted. Be sure that the sensor

is not on too tight.

Set instrument to MAX sensitivity.

Warm the patient or sensor site.

Move sensor to better perfused site.

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

PROBLEM POSSIBLE

CAUSE(S) RECOMMENDATION

LOW SIGNAL QUALITY

Improper sensor type

or application.

Excessive motion

relative to perfusion.

Sensor is damaged or

not functioning.

Check and see if blood flow to the site is

restricted.

Check the placement of the sensor.

Re-apply sensor or move to a different site

SpO2 VALUES DO NOT

CORRELATE WITH CLINICAL

ASSESSMENT OR ABGs

Low perfusion or

sensor displacement.

Check for error messages. See section

5 System Messages for recommended

corrections.

Check placement of sensor or if it is too tight.

Reapply sensor or select a new site.

Set to MAX sensitivity and confirm that

the sensor is securely on the patient.

Refer to sensor Directions For Use.

PULSE SEARCH MESSAGE

Instrument is searching

for pulse.

If instrument fails to display within 30

seconds, disconnect and reconnect. If

pulse search continues, move sensor to

better perfused site.

UNEXPECTED SpO2, SpCO,

SpMet OR SpHb READING

Low SIQ or Perfusion

Index (PI) values.

Reposition sensor to site with strong SIQ

and PI. Average readings taken from three

different sites to improve accuracy. Submit

blood sample for laboratory CO-Oximetry test

for comparison.

Inappropriate sensor

size or sensor

measurement location.

Verify proper sensor for patient size.

Verify proper sensor site.

UNEXPECTEDLY HIGH

SpCO READING

Possible elevated

methemoglobin level.

Submit blood sample for laboratory

CO-Oximetry test.

HANDHELD BATTERY

DOES NOT CHARGE

AC power cable may

be disconnected. Restore power to the instrument.

LED LIGHTS ON LEFT SIDE

OF DOCKING STATION

CONTINUOUSLY FLASH

ncompatible version of

software on Radical-7R

handheld and docking

station.

Upgrade to current software versions.

Match handheld to docking station with

compatible software versions.

BATTERY RUN-TIME IS

SIGNIFICANTLY REDUCED

Battery Memory effects

.Use Battery Discharge function as

described in Section 4, Service.

Troubleshooting

Troubleshooting (continued)

Radical-7R Pulse CO-Oximeter Operator’s Manual 6-3

PROBLEM POSSIBLE

CAUSE(S) RECOMMENDATION

DIFFICULTY OR NO

SpCO/SpMet/SpHb

READING

Low battery/ not plugged

into AC power supply.

Insert handheld into docking station, verify

docking station power cord plugged in

and docking station power indicator light

is illuminated.

nterference from line-

frequency induced noise.

Verify/set 50/60hz menu setting. Refer to

Section 3, Initial Setup for details.

Inappropriate sensor or

sensor size.

Verify proper sensor and sensor size for

the patient.

Excessive ambient or

strobing light.

Shield the sensor from excessive or

strobing light.

Excessive motion. Minimize or eliminate motion at the

monitoring site.

Also, see Section 4, Successful Monitoring for additional

information.

Troubleshooting (continued)

Troubleshooting

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

Specifications

Radical-7R specifications

PERFORMANCE

Measurement Range

SpO2: 0 -100%

SpMet: 0 - 99.9%

SpCO: 0 - 99%

SpHb 0 - 25 g/dl

SpOC 0 - 35 ml of O2/dl of blood

SpHct 0 - 75%

Pulse Rate: 25 - 240 (bpm)

RRa (Respiration Rate) 0-70 breaths per minute

SIQa 0-100%

Perfusion Index: 0.02% - 20%

Pleth Variability Index: 0 - 100%

ACCURACY

Arterial Oxygen Saturation Accuracy1

Saturation 60% to 80%

No Motion

Adults, Infants, Pediatrics ±3%

Saturation 70% to 100%

No Motion2

Adults, Infants, Pediatrics ± 2%

Neonates ± 3%

Motion3

Adults, Infants, Pediatrics, Neonates ± 3%

Low Perfusion4

Adults, Infants, Pediatrics, Neonates ± 2%

Pulse Rate Accuracy5

Pulse rate: 25 - 240 bpm

No Motion

Adults, Infants, Pediatrics, Neonates ± 3 bpm

Motion

Adults, Infants, Pediatrics, Neonates ± 5 bpm

Low Perfusion4

Adults, Infants, Pediatrics, Neonates ± 3 bpm

Carboxyhemoglobin saturation accuracy (%SpCO)1

Adults, Infants, Pediatrics 1% - 40% ± 3%

Methemoglobin saturation accuracy (%SpMet)1

Adults, Infants, Pediatrics, Neonates 1% - 15% ± 1%

Total Hemoglobin accuracy (SpHb g/dl)6

Adults, Pediatrics 8 - 17 g/dl ±1 g/dL

Respiratory Rate Accuracy (RRa, breaths per minute)7

Adults 4 to 70 ± 1 breath per minute

Resolution

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

Arterial Oxygen Saturation (%SpO2)1%

Carboxyhemoglobin Saturation (%SpCO) 1%

Methemoglobin Saturation (%SpMet) 0 .1%

Total Hemoglobin (SpHb g/dl)

0.1 g/dl

Respiration Rate (RRa) 1 breath per minute

Pulse Rate (bpm) 1 bpm

ELECTRICAL

Standalone

AC Power requirements: 100-240 VAC, 47-63 Hz

Power consumption: 55 VA

Fuses: 1 Amp, Fast Acting, Metric, (5x20mm), 250V

Batteries

Handheld:

Type: NiMH

Capacity: 4 hours8

Charging time: 3 hours

Docking Station (RDS-1B):

Type: NiMH

Capacity: 10 hours8

Charging time: 6 hours

ENVIRONMENTAL

Operating Temperature: 41°F to 104°F (5°C to 40°C)

Transport/Storage Temperature: -40°F to 158°F (-40°C to +70°C)9

Operating Humidity: 5% to 95%, non-condensing

Operating Altitude: 500 mbar to 1060 mbar pressure

-1000 ft to 18,000 ft (-304 m to 5,486 m)

PHYSICAL CHARACTERISTICS

Dimensions

Handheld: 8.9” x 3.5” x 2.1” (22.6 cm x 8.9cm x 5.3 cm)

Standalone: 3.5” x 10.5” x 7.7” (8.9 cm x 26.7cm x 19.6cm)

Weight

Handheld: 1.2 lbs. (0.54 kg)

Docking Station (RDS-1, RDS-2, RDS-3): 2.5 lbs. (1.14 kg)

Docking Station (RDS-1B): 4.11 lbs (1.86 kg)

Standalone (RDS-1, RDS-2, RDS-3): 3.8 lbs. (1.73 kg)

Standalone (RDS-1B): 5.4 lbs. (2.45 kg)

Mode

Averaging mode: 2, 4, 8,10, 12, 14 or 16 seconds10

Sensitivity: Normal and Maximum11 and APOD

Alarms

Specifications

Radical-7R specifications (contin

ued)

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

Specifications

Audible and visual alarms for high low saturation and pulse rate (SpO2 range 1% - 99%, SpCO range

1% - 98%, SpMet range 1% - 99.5%, SpHb range1 g/dl - 24.5 g/dl, RRa range 4 - 70 breaths per min-

ute, PI range 0.03% - 19%, PVI range 1% - 99%, pulse rate range 30 - 235 BPM)

Sensor condition, system failure and low battery alarms

High Priority: 571 Hz tone, 5 pulse burst, pulse spacing: 0.250s,

0.250s, 0.500s, 0.250s, repeat time:10s

Medium Priority: 550 Hz tone, 3 pulse burst, pulse spacing: 0.375s,

0.375s, repeat time: 7s

Low Priority: 500 Hz tone, 1 pulse burst, repeat time: 5s

Alarm Muted reminder: 500Hz tone, 2 pulse burst, pulse spacing 0.375s,

repeat time: 3min.

Alarm Volume:

High Priority: 70 dB (min),

Medium Priority: 70 dB (min),

Low Priority: 45 dB (min)

Display/Indicators

Data display:

%SpO2, %SpCO, %SpMet, SpHb g/dl, SpOC ml/dl, %SpHct, PVI, pulse rate, RRa,

plethysmographic waveform, respiration indicator, alarm status, status messages, Signal IQ,

SIQa, perfusion index, APOD and FastSat

Display update rate: 1 second

Response Time: < 20 second delay

Type: Backlit Active Matrix TFT LCD

Pixels: 480 x 272 dots

Dot Pitch: 0.25 mm

Output Interface

Satshare (RDS-1, RDS-1B)

Serial RS-232 (RDS-1, RDS 1B, RDS-3)

Nurse Call/Analog Output (RDS-1, RDS-1B, RDS-3)

Philips Vuelink, Spacelabs Universal Flexport, RadNet, RadLink (RDS-1, RDS-1B, RDS-3)

Compliance

EMC Compliance: EN60601-1-2, Class B

Equipment Classification: IEC 60601-1 / UL 60601-1

Type of Protection Class 1 (on AC power), Internally powered (on battery power)

Degree of Protection-Patient Cable: Type BF-Applied Part

Degree of Protection-SatShare Cable: Type CF-Applied Part

Mode of Operation: Continuous

SpO2, SpCO and SpMet accuracy was determined by testing on healthy adult volunteers in the range 60% - 100% SpO2, 0% - 40% SpCO

and 0% - 15% SpMet against a laboratory CO-Oximeter. SpO2 and SpMet accuracy was determined on 16 neonatal NICU patients ranging

in age from 7 to 135 days old and weighting between 0.5 and 4.25 kgs. Seventy-nine (79) data samples were collected over a range of 70

- 100% SaO2 and 0.5 - 2.5% HbMet with a resultant accuracy of 2.9% SpO2 and 0.9% SpMet. Contact Masimo for testing specifications.

The Masimo sensors have been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with

light to dark skin pigmentation in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor.

This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.

3 The Masimo sensors have been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with

light to dark skin pigmentation in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude

Radical-7R specifications (contin

ued)

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

of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of

70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor. This variation equals plus or minus one standard deviation.

Plus

or minus one standard deviation encompasses 68% of the population.

4 The Radical-7R has been validated for low perfusion accuracy in bench-top testing against a Fluke Biotek Index 2 simulator and

Masimo's simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations and pulse rates

within the stated accuracy specifications. This variation equals plus or minus one standard deviation. Plus or minus one standard

deviation encompasses 68% of the population.

5 Masimo sensors have been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index

2 simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the population.

6 SpHb accuracy has been validated on healthy adult male and female volunteers and on surgical patients with light to dark skin

pigmentation in the range of 8 g/dL to 17 g/dL SpHb against a laboratory CO-Oximeter. The variation equals plus or minus one standard

deviation which encompasses 68% of the population. The SpHb accuracy has not been validated with motion or low perfusion.

7 Respiration rate accuracy for the Masimo Acoustic Respiration sensor and instrument has been validated for the range of 4 to 70

breaths per minute in bench top testing. Clinical validation for up to 30 breaths per minute was also performed with the Masimo Acoustic

Respiration sensor and instrument.

8 This represents approximate run time at the lowest indicator brightness and pulse tone turned off using a fully charged battery.

9 If the batteries are to be stored for extended periods of time, it is recommended that they be stored between -20°C to +30°C, and at a

relative humidity less than 85%. If stored for a prolonged period at environmental conditions beyond these limits, overall battery capacity

may be diminished, and lifetime of the batteries may be shortened.

10 With FastSat the averaging time is dependent on the input signal. For the 2 and 4 second settings the averaging time may range from

2-4 and 4-6 seconds, respectively.

11 Maximum sensitivity mode fixes perfusion limit to 0.02%.

Analog Output/Nurse Call Specifications

The Analog Out and Nurse Call features are accessible on a female high density DB-15 connector.

NOTE: The Radical-7R Pulse CO-Oximeter analog output / nurse call interface is only available

when the Radical-7R Pulse CO-Oximeter Handheld is properly attached to the Radical-7R Pulse

CO-Oximeter Docking Station. Only use an analog / nurse call cable that has a ferrite bead installed.

NOTE: The analog output / nurse call interface is not available in all versions of the Docking Station.

The following table shows the pinout of the analog output and nurse call.

PIN SIGNAL NAME

1Reserved

2Ground

3Ground

4Ground

5Ground

6Nurse Call (Normally Open)

7Nurse Call (Normally Closed)

8Ground

9Analog 1

10 Ground

11 Ground

12 Nurse Call – Common

13 Ground

14 Ground

15 Analog 2

Specifications

Radical-7R specifications (contin

ued)

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

ANALOG OUTPUT

The Radical-7R Pulse CO-Oximeter can interface with various analog recording devices

and/or strip chart recorders through its Analog Output connector located on the back of

the Docking Station. Depending on the configuration of the Output menu, the following

parameters are output continuously on the Analog 1 and Analog 2 channels:

■ SpO2

■ Pulse rate

■ Plethysmographic waveform

■ Signal IQ

The output signals vary from approximately 0 to 1 volt in a linear fashion.

NOTE: The actual Analog 1 and Analog 2 output voltage that are generated may not

exactly range between 0.0V to 1.0V. A variance of ± 40 mV is acceptable.

NURSE CALL

The nurse call feature is available when Radical-7R Pulse CO-Oximeter is operating in its

standalone configuration. The nurse call feature on the Radical-7R Pulse CO-Oximeter is

based on the relay closing or opening depending on alarm, Low Signal IQ events or both.

For maximum flexibility, either normally open (pin 6) or normally closed (pin 7) signals are

available. Only qualified personnel should connect one of these two signals and common (pin

12) to a hospital’s nurse call system. During an alarm condition, or a Low Signal IQ event,

depending on the configuration of the output menu, the normally open pin will be connected

to the common pin and the normally closed will be disconnected. In addition, the nurse call

polarity can be inverted to accommodate various nurse call station requirements.

The nurse call relays have the following electrical specifications per switch:

PARAMETER SPECIFICATION

MAX VOLTAGE 100VDC or AC peak

MAX CURRENT 100mA

Specifications

WARNING: THE NURSE CALL FEATURE IS DISABLED WHEN THE AUDIBLE

ALARMS ARE SILENCED WHILE THE NURSE CALL SETTING IN THE

OUTPUT MENU IS SET TO “ALARMS”.

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

Sensors & Patient Cables

Introduction

This section covers the use and cleaning of Masimo sensors and patient cables.

Before use of any sensor, carefully read the sensor’s Directions for Use.

Use only Masimo sensors and cables with the Radical-7R Pulse CO-Oximeter. Other

transducers, sensors and cables may affect the Radical-7R Pulse CO-Oximeter performance.

Tissue damage can be caused by incorrect application or use of a sensor, for example by

wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor Directions for

Use to ensure skin integrity, correct positioning and adhesion of the sensor.

CAUTIONS:

■ DO NOT USE DAMAGED SENSORS OR PATIENT CABLES. DO NOT USE A SENSOR

OR PATIENT CABLE WITH EXPOSED OPTICAL OR ELECTRICAL COMPONENTS.

■

DO NOT IMMERSE THE SENSOR OR PATIENT CABLE IN WATER, SOLVENTS, OR

CLEANING SOLUTIONS (THE SENSORS AND CONNECTORS ARE NOT WATERPROOF).

■ UNLESS OTHERWISE SPECIFIED, DO NOT STERILIZE SENSORS OR PATIENT

CABLES BY IRRADIATION, STEAM, AUTOCLAVE OR ETHYLENE OXIDE. SEE

THE CLEANING INSTRUCTIONS IN THE DIRECTIONS FOR USE FOR REUSABLE

MASIMO SENSORS.

■ DO NOT ATTEMPT TO REPROCESS, RECONDITION OR RECYCLE ANY MASIMO

SENSORS OR PATIENT CABLES AS THESE PROCESSES MAY DAMAGE THE

ELECTRICAL COMPONENTS, POTENTIALLY LEADING TO PATIENT HARM.

■ ALL SENSORS AND CABLES ARE DESIGNED FOR USE WITH SPECIFIC

MONITORS. VERIFY THE COMPATIBILITY OF THE MONITOR, CABLE AND SENSOR

BEFORE USE, OTHERWISE PATIENT INJURY CAN RESULT.

■ TO AVOID DAMAGE TO THE CABLES, ALWAYS HOLD THE CABLE BY

THE CONNECTOR RATHER THAN THE CABLE WHEN CONNECTING OR

DISCONNECTING EITHER END.

SELECTING A MASIMO SET SENSOR

When selecting a sensor, consider the patient’s weight, the adequacy of perfusion, the

available sensor sites, and the duration of monitoring. For more information refer to the

following tables or contact your Sales Representative. Use only Masimo sensors and sensor

cables. Select an appropriate sensor, apply it as directed, and observe all warnings and

cautions presented in the Directions for Use accompanying the sensor. Monitor, cables

and sensors must be compatible to ensure optimal performance. Incompatible components

effect operation or data recovery.

High intensity extreme lights (such as pulsating strobe lights) directed on the CO-Oximeter

sensors, may not allow the sensor to obtain measurements. Excessive ambient light sources

such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent

lights, infrared heating lamps, and direct sunlight, as well as other monitor displays can

interfere with the performance of the sensor. To prevent interference from ambient light,

ensure that the sensor is properly applied, and cover the sensor site with a Masimo Optical

Shield, if required. Failure to take this precaution in excessive ambient light conditions may

result in inaccurate measurements.

SENSOR APPLICATION INSTRUCTIONS

Unless indicated otherwise in the directions for use, reposition reusable sensors at least every 4

hours and for adhesive sensors inspect the site at least every 8 hours or sooner. If indicated by

circulatory condition or skin integrity, reapply to a different monitoring site.

8-2 Radical-7R Pulse CO-Oximeter Operator’s Manual

8Sensors & Patient Cables

Masimo Sensors

The following sensors are compatible for use with the Radical-7R Pulse CO-Oximeter.

See the sensor directions for use for full sensor specifications, including accuracy.

MASIMO ACOUSTIC RESPIRATION SENSOR

The Acoustic Respiration sensor must be used with the Radical-7R Pulse CO-Oximeter to

enable monitoring of respiration rate (RRa).

Acoustic Respiration Sensor

The Acoustic Respiration sensor must be used in conjunction with the Acoustic Respiration

PC and Dual Rainbow Cable.

• RA-125

MASIMO RAINBOW SENSORS

Masimo Rainbow sensors must be used for the Radical-7R Pulse CO-Oximeter parameters to

enable measurement of Oxyhemoglobin (SpO2), Carboxyhemoglobin (SpCO), Methemoglobin

(SpMet) and Total Hemoglobin (SpHb). Rainbow sensors will only function with instruments

containing Masimo Rainbow SET Technology or licensed to use Rainbow compatible sensors.

Rainbow Adhesive Sensors

Rainbow adhesive sensors must be used in conjunction with Rainbow PC cables.

R1 25•

R 25•

R1 25L•

R 25L•

R1 20•

R 20•

R1 20L•

R 20L•

Rainbow ReSposable™ Pulse CO-Oximeter Sensor System

The Rainbow ReSposable Sensors are used as a system.

•

R2-25a with R2-25r

•

R2-20a wth R2-20r

Rainbow Reusable Sensors

Rainbow Reusable sensors must be used in conjunction with Rainbow RC cables.

DCI•

DCIP•

DCI SC-360•

DCIP SC-360•

Radical-7R Pulse CO-Oximeter Operator’s Manual 8-3

Sensors & Patient Cables

Masimo Sensors continued

Rainbow Direct Connect Sensors

Rainbow Direct Connect sensors connect to the instrument directly.

•

DCI-dc3

•

DCI-dc8

•

DCI-dc12

•

DCIP-dc3

•

DCIP-dc8

•

DCIP-dc12

•

DC-3 SC360

•

DC-12 SC360

•

DCP-3 SC360

•

DCP-12 SC360

•

DC-3 SC200

•

DCP-3 SC200

MASIMO SPO2 SENSORS

The Radical-7R may use standard Masimo LNOP, LNOPv and LNCS SpO2 sensors,

when used with Red PC or Red LNC Patient Cables respectively. Select the appropriate

patient cable to attach the LNOP or LNCS sensor to the instrument.

ReSposable™ Pulse CO-Oximeter Sensor System

The Rainbow ReSposable Sensors are used as a system.

• S2-25a with S2-25r

• S2-20a with S2-20r

Red Direct Connect Sensors

Masimo Red sensors can be used with the Radical-7R to enable measurement of SpO2

and pulse rate only. Red sensors will only function with Pulse CO-Oximeter instruments

equipped with Masimo Rainbow SET technology. Red Direct Connect sensors connect

to the instrument directly.

• DC-3

• DC-12

8-4 Radical-7R Pulse CO-Oximeter Operator’s Manual

8Sensors & Patient Cables

• DCP-3

• DCP-12

Masimo Sensors continued

LNOP® Reusable Sensors

LNOP sensors must be used in conjunction with Red PC cables.

• DCI

• DCIP

• YI

• TC-I

• DC-195

• TF-I

LNOP® Adhesive Sensors

LNOP sensors must be used in conjunction with Red PC cables.

• Adt/Adtx

• Pdt/Pdtx

• Inf

• Neo

• NeoPt

LNOPvTM Adhesive Sensors

LNOPv sensors must be used in conjunction with Red PC cables.

• In

• Ne

• Ad

LNOP® Specialty Sensors

LNOP sensors must be used in conjunction with Red PC cables.

• Newborn Infant/Pediatric

• Newborn Neonatal

• Trauma

• Blue

M-LNCS™/LNCS® Reusable Sensors

LNCS sensors must be used in conjunction with LNC cables.

• DCI

• DCIP

• YI

Radical-7R Pulse CO-Oximeter Operator’s Manual 8-5

Sensors & Patient Cables

• TC-I

• TF-I

Masimo Sensors continued

M-LNCS™/LNCS® Adhesive Sensors

LNCS sensors must be used in conjunction with Red LNC cables.

• Adtx

• Pdtx

• Inf

• Neo

• NeoPt

• NeoPt-500

M-LNCS™/LNCS® Specialty Sensors

LNCS specialty sensors must be used in conjunction with Red LNC cables.

• Newborn Infant/Pediatric

8-6 Radical-7R Pulse CO-Oximeter Operator’s Manual

8Sensors & Patient Cables

• Newborn Neonatal

• Trauma

Masimo Sensors continued

SENSOR ACCURACY

See Sensor Directions for Use (DFU) for sensor accuracy specifications for: SpO2, SpMet,

SpCO, SpHb, pulse rate and respiration rate.

CLEANING AND REUSE OF MASIMO REUSABLE SENSORS AND CABLES

Reusable sensors and patient cables can be cleaned per the following procedure:

1. Remove the sensor from the patient.

2. Disconnect the sensor from the patient cable.

3. Disconnect the patient cable from the monitor.

4. Wipe the entire sensor and/or patient cable clean with a 70% isopropyl alcohol pad.

5. Allow to air dry thoroughly before returning it to operation.

CAUTION: CAREFULLY ROUTE PATIENT CABLES TO REDUCE THE POSSIBILITY OF

PATIENT ENTANGLEMENT OR STRANGULATION.

REATTACHMENT OF A SINGLE USE ACOUSTIC RESPIRATION SENSOR

■ A single use Acoustic Respiration sensor may be reapplied to the same patient if it is

dry, clean, free of debris and oil and the adhesive still adheres to the skin.

REATTACHMENT OF SINGLE USE ADHESIVE SENSORS

Single use sensors may be reapplied to the same patient if the emitter and detector windows are

clear and the adhesive still adheres to the skin.

NOTE: If the sensor fails to track the pulse consistently, the sensors may be incorrectly

positioned. Reposition the sensor or choose a different monitoring site.

CAUTION: DO NOT ATTEMPT TO REPROCESS, RECONDITION OR RECYCLE ANY

MASIMO SENSORS OR PATIENT CABLES AS THESE PROCESSES MAY

DAMAGE THE ELECTRICAL COMPONENTS, POTENTIALLY LEADING TO

PATIENT HARM.

CAUTION:

TO PREVENT DAMAGE, DO NOT SOAK OR IMMERSE THE SENSOR IN ANY

LIQUID SOLUTION. DO NOT ATTEMPT TO STERILIZE BY IRRADIATION, STEAM,

AUTOCLAVE OR ANY METHOD OTHER THAN ETHYLENE OXIDE AS INDICATED

WARNING: TO AVOID CROSS CONTAMINATION ONLY USE MASIMO SINGLE

USE

SENSORS ON THE SAME PATIENT.

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

Service / Maintenance

Introduction

This section covers:

■ How to properly clean the Radical-7R Pulse CO-Oximeter.

■ How to recharge and replace the batteries.

■ How to replace the fuses.

■ How to obtain service.

Under normal operation, no internal adjustment or recalibration is required. Safety tests and

internal adjustments should be done by qualified personnel only. Safety checks should be

performed at regular intervals or in accordance with local and governmental regulations.

WARNING:ELECTRICAL SHOCK AND FLAMMABILITY HAZARD - BEFORE CLEANING

THE PULSE CO-OXIMETER, ALWAYS TURN IT OFF AND DISCONNECT

THE POWER CORD FROM THE AC POWER SUPPLY.

The Masimo Rainbow SET® Radical-7R Pulse CO-Oximeter is a reusable instrument. The

instrument is supplied and used non-sterile.

Cleaning

The outer surface of the Masimo Rainbow SET® Radical-7R Pulse CO-Oximeter can be

cleaned with a soft cloth dampened with a mild detergent and warm water solution. Do not allow

liquids to enter the interior of the instrument. The outer surface of the instrument can also be

wiped down using the following solvents: Cidex Plus (3.4% Glutaraldehyde), 10% Bleach, and

70% Isopropyl Alcohol.

■ DO NOT AUTOCLAVE, PRESSURE STERILIZE, OR GAS STERILIZE THE

PULSE CO-OXIMETER.

■ DO NOT SOAK OR IMMERSE THE PULSE CO-OXIMETER IN ANY LIQUID.

■ USE THE CLEANING SOLUTION SPARINGLY. EXCESSIVE SOLUTION CAN FLOW INTO

THE PULSE CO-OXIMETER AND CAUSE DAMAGE TO INTERNAL COMPONENTS.

■

DO NOT TOUCH, PRESS, OR RUB THE DISPLAY PANELS WITH ABRASIVE CLEANING

COMPOUNDS, INSTRUMENTS, BRUSHES, ROUGH-SURFACE MATERIALS, OR BRING

THEM INTO CONTACT WITH ANYTHING THAT COULD SCRATCH THE PANEL.

■ DO NOT USE PETROLEUM-BASED OR ACETONE SOLUTIONS, OR OTHER HARSH

SOLVENTS, TO CLEAN THE PULSE CO-OXIMETER. THESE SUBSTANCES ERODE

THE INSTRUMENT’S MATERIALS AND INSTRUMENT FAILURE CAN RESULT.

Refer to Section 8, Cleaning and Reuse of Masimo Sensors for cleaning instructions of the sensor.

9-2 Radical-7R Pulse CO-Oximeter Operator’s Manual

Battery Operation and Maintenance

The Radical-7R Pulse CO-Oximeter Handheld includes a 1.5 Amp-Hour Nickel Metal Hydride

battery. The Radical-7R Pulse CO-Oximeter Docking Station may include the optional 6.5 Amp-

Hour Nickel Metal Hydride battery.

Before using the Radical-7R Pulse CO-Oximeter as a Handheld or transport monitor, the

Handheld battery and the optional Docking Station battery need to be fully charged.

To charge the battery(s), attach the Handheld instrument to the Docking Station. Ensure that

AC power is attached to the Docking Station. Verify that the battery(s) is charging; the battery

charging LED indicators on the Docking Station flash prior to charging and remain illuminated

while the battery(s) is charging. A continuously flashing battery charging LED indicates that the

internal battery temperature exceeds recommended operating conditions for proper battery

charging. Proper battery charging will proceed when the temperature returns to recommended

operating conditions.

The Handheld battery requires approximately 2 to 3 hours for charging. The optional Docking

Station battery requires approximately 6 hours for charging.

When the battery charging LED indicators turn off, additional trickle charging may occur to complete

charging. Although battery charging can occur while the Handheld is docked and powered on, most

efficient charge times are achieved with the Handheld instrument turned off.

CAUTIONS:

■ ALL BATTERIES LOSE CAPACITY WITH AGE, THUS THE AMOUNT OF RUN TIME

LEFT AT LOW BATTERY WILL VARY DEPENDING UPON THE AGE OF THE BATTERY.

■ AT LOW BATTERY CONNECT THE RADICAL-7R PULSE CO-OXIMETER TO AC

POWER TO PREVENT LOSS OF POWER.

During battery operation of the Radical-7R Pulse CO-Oximeter, please note that the following

operating conditions affect the estimated run-time of the included batteries:

■

VOLUME OF THE ALARM TONES. TO CONSERVE BATTERY POWER, KEEP THE

FREQUENCY OF THE AUDIBLE ALARMS TO A MINIMUM AND AT MINIMUM VOLUME.

Memory effects of the battery pack may shorten run-time. When battery run-time is significantly reduced,

it is advisable to completely discharge and fully recharge the battery pack. To properly discharge the

battery pack, use the Battery Discharge function as described in Section 4, under Service.

CAUTION:

■ IF THE RADICAL-7R PULSE CO-OXIMETER HANDHELD HAS NOT BEEN USED OR

CHARGED WITHIN SEVEN (7) DAYS OR MORE, THEN RECHARGE THE BATTERY

PRIOR TO USE.

■ IT IS RECOMMENDED THAT THE RADICAL-7R PULSE CO-OXIMETER HANDHELD IS

DOCKED TO THE DOCKING STATION ATTACHED TO AN AC POWER SOURCE WHEN

IT IS NOT IN USE TO ENSURE THAT THE BATTERY REMAINS FULLY CHARGED.

The following tables outline the estimated run times of the battery powered Radical-7R Pulse

CO-Oximeter. The time estimates are based on a Radical-7R Pulse CO-Oximeter with fully

charged batteries. The Radical-7R Pulse CO-Oximeter is always configured to include the

Handheld battery. It may optionally be configured to include the Docking Station battery. Please

determine the configuration of your system before referencing the following tables.

Service / Maintenance

Radical-7R Pulse CO-Oximeter Operator’s Manual 9-3

CONFIGURATION #1:

Radical-7R Pulse CO-Oximeter configured to only include the Handheld battery (standard

configuration); the Docking Station battery is excluded.

NOTE: For this configuration, it is advisable to operate only the Radical-7R Handheld instrument

when running on battery power. Although it is possible to operate the entire Standalone

instrument (the Handheld attached to the Docking Station, with the Handheld battery powering

the Docking Station as well) on battery power, the capacity of the Handheld battery pack is

insufficient to support this mode for long periods of time.

RADICAL-7R CONFIGURATION MINIMUM RUN-TIME

HANDHELD ONLY 1 hr

CONFIGURATION #2:

Radical-7R configured to include the Handheld and the Docking Station battery:

RADICAL-7R CONFIGURATION MINIMUM RUN-TIME

HANDHELD AND DOCKING STATION 6 hr

REPLACING THE BATTERIES

Before installing or removing the battery, make sure the AC power cord is removed and power to

the Pulse CO-Oximeter is turned off.

To replace the Handheld battery, follow these instructions:

Turn the Radical-7R Pulse CO-Oximeter Handheld off and remove the patient cable

connection. Detach the Radical-7R Pulse CO-Oximeter Handheld from the Docking Station

(if docked).

2. Loosen the closure screw on the battery compartment door and lift out the battery.

3. Take a new battery, and place it in the compartment.

4. Tighten the closure screw.

5. Place Handheld into Docking Station, turn on line power and charge battery according to

this Section, Battery Operation and Maintenance.

CAUTION: FOLLOW LOCAL GOVERNING GUIDELINES FOR PROPER DISPOSAL OF

INTERNAL BATTERIES. DO NOT INCINERATE.

WARNING: THE DOCKING STATION BATTERY SHOULD BE INSTALLED AND/

OR REMOVED FROM DOCKING STATION BY QUALIFIED

PERSONNEL ONLY.

REPLACING THE FUSES

Should a power problem blow one or both of the fuses in the power entry module on the rear

panel, the fuse(s) will need to be replaced.

Service / Maintenance

Battery Operation and Maintenance

(continued)

9-4 Radical-7R Pulse CO-Oximeter Operator’s Manual

9Service / Maintenance

To replace the fuse(s), you will need a flat-blade screwdriver (5mm; 3/16”).

To replace the fuses:

1. Disconnect instrument from AC power.

2. Remove AC power cord from the power entry module at the rear of the docking station.

3. Use the small flat-blade screwdriver and gently pry loose the fuse cover in the left portion

of the power entry module, exposing the fuse holder.

4. Using the small flat-blade screwdriver, gently remove the fuse holder.

5. Note how the fuse(s) are placed in the fuse holder for installation of the new fuse(s).

6. To remove the fuses from the fuse holder, use the edge of the screwdriver blade to pry

against the bottom of the metal portion of the fuse where it is secured to the glass portion

of the fuse.

7. Place the fuse(s) (1 Amp, Metric, fast acting, 5x20mm, 250V) in the fuse holder, properly

orienting the fuse(s).

8. Slide the fuse holder back into the power entry module and press firmly to make sure it is

completely seated.

9. Close the fuse cover and press gently until it seats completely, flush with the back of

the docking station.

10. The instrument is ready to be reconnected to AC power.

NOTE: If the fuses blow shortly after replacement, the instrument requires service.

WARNING: FIRE HAZARD: TO PROTECT AGAINST FIRE HAZARD, REPLACE ONLY

WITH FUSES OF THE SAME TYPE, CURRENT RATING, AND VOLTAGE

RATING.

Performance Verification

To test the performance of the Radical-7R Pulse CO-Oximeter following repairs or during routine

maintenance, follow the procedure outlined in this section. If the Radical-7R Pulse CO-Oximeter fails

any of the described tests, discontinue its use and correct the problem before returning the instrument

back to the user.

Before performing the following tests place the Radical-7R Pulse CO-Oximeter Handheld into

the Docking Station, connect the Radical-7R to AC power and fully charge the Radical-7R Pulse

CO-Oximeter Handheld battery. Also disconnect any patient cables or pulse oximetry probes, as well as

SatShare, serial or analog output cables from the instrument. Set the Radical-7R Pulse CO-Oximeter to

normal operating mode by selecting the Home Use parameter in the General Menu to “No”.

Power-On Self-Test:

1. Connect the monitor to AC power and verify that the AC Power Indicator is lit.

Turn the monitor on by depressing the Power/Standby Button. Within 5 seconds all available

LEDs are illuminated, a 1-second beep tone sounds, and the Masimo SET logo is displayed.

3. The blue Docking Indicator LED is illuminated and the Radical-7R begins normal

operation.

Alarm Limit Test:

Radical-7R Pulse CO-Oximeter Operator’s Manual 9-5

Service / Maintenance

1. With the monitor turned on, select the Menu Access key and enter the Alarm menu.

Change the High SpO2 Alarm parameter to a value two points below the currently selected

value, and accept the change.

2. Verify that the newly set parameter is shown on the Saturation Alarm Limit Display, next to

the SpO2 or pulse rate measurement display.

3. Return the High Saturation Alarm parameter to its original setting.

4. Repeat steps 1 to 3 for the following alarm parameters:

■ Low SpO2

■ High and Low Pulse Rate

■ High and Low Respiration Rate (RRa)

■ High SpMet

■ High SpCO

■ High and Low SpHb

■ PI

■ PVI

5. Reset the alarm limits again to the original settings.

Testing with Masimo SET Tester (Optional):

1. Turn the Radical-7R off and then on again.

2. Connect the Masimo SET Tester to the Pulse CO-Oximeter Patient Cable Connector. Refer

to the Masimo SET Tester's Directions for Use for further instructions.

Nurse Call Test:

1. Disconnect the Red patient cable or the Masimo SET Tester from the Radical-7R and turn

the instrument on. Ensure that there are no audible alarms and that the audible alarms are

not silenced. Verify the nurse call polarity is set to normal (default).

2. Connect the common lead of a digital multi-meter to the pin 12 (Nurse Call - Common)

of the analog output connector on the Radical-7R. Connect the positive lead of the multi-

meter to pin 6 (Nurse Call - Normally Open) of the analog output connector and measure

that the resistance is greater than 1 MW (open circuit).

3. Trigger an alarm on the monitor (e.g. by disconnecting a sensor after it was measuring

data) and verify that the resistance is less than 35 ohms.

Analog Output Test

1. Disconnect all patient cables and sensors from the Radical-7R. Turn the Radical-7R

off and then on again.

2. Connect the common lead of a digital voltmeter to the pin 2 (Ground) of the analog

output connector on the Radical-7R Connect the positive lead of the voltmeter to pin

9 (Analog 1) of the analog output connector.

3. Enter the menu system and set the “Output”, “Analog 1” to “0V Signal”. Verify that the

voltmeter measures a voltage of approximately 0V.

4. Enter the menu system and set the “Output”, “Analog 1” to “1V Signal”. Verify that the

voltmeter measures a voltage of approximately 1.0V.

5. Repeat Steps 3 and 4, with the positive lead of the voltmeter connected to pin 15

(Analog 2).

9-6 Radical-7R Pulse CO-Oximeter Operator’s Manual

9Service / Maintenance

6. Connect a patient cable and sensor and verify that the voltage on pins 9 and 15 are

between 0V and 1.0V while measuring a saturation and pulse rate.

Battery Test:

1. Fully charge the Radical-7R by placing the Handheld into the Docking Station and

connecting the AC power.

2. Verify that the green Handheld Battery Indicator LED is illuminated.

3. When the Radical-7R is fully charged the green Handheld Battery Indicator turns off.

4. Turn the Radical-7R on and verify that the Battery indicator shows a full charge.

Service and Repair

REPAIR POLICY

Masimo or an authorized Service Department must perform warranty repair and service. Do not

use malfunctioning equipment. Have the instrument repaired.

WARNING: DO NOT REMOVE THE COVER OF THE MONITOR EXCEPT FOR

BATTERY REPLACEMENT. AN OPERATOR MAY ONLY PERFORM

MAINTENANCE PROCEDURES SPECIFICALLY DESCRIBED IN THIS

MANUAL. REFER SERVICING TO QUALIFIED SERVICE PERSONNEL

TRAINED IN THE REPAIR OF THIS EQUIPMENT.

Please clean contaminated and/or dirty equipment before returning, following the cleaning

procedure described in Section 9, Cleaning. Make sure the equipment is fully dry before packing.

To return the Radical-7R instrument for service, please follow the Return Procedure.

RETURN PROCEDURE

Please clean contaminated/dirty equipment before returning. Make sure the equipment is fully

dry before packing. Call Masimo at 800-326-4890 and ask for Technical Support. Ask for an RMA

number. Package the equipment securely – in the original shipping container if possible – and

enclose or include the following information and items:

■ A letter describing in detail any difficulties experienced with the Pulse CO-Oximeter.

Please include the RMA number in the letter.

■

Warranty information – a copy of the invoice or other applicable documentation must be included.

■ Purchase order number to cover repair if the Pulse CO-Oximeter is not under warranty, or

for tracking purposes if it is.

■ Ship-to and bill-to information.

■ Person (name, telephone/Telex/fax number, and country) to contact for any questions

about the repairs.

■

A certificate stating the Pulse CO-Oximeter has been decontaminated for bloodborne pathogens.

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

Service / Maintenance

Return Radical-7R Pulse CO-Oximeter to the following shipping address:

For USA, Canada & Asia Pacific: For Europe: All other locations:

Masimo Corporation

40 Parker

Irvine, California 92618

949-297-7000

FAX 949-297-7001

Masimo International Sàrl

Puits-Godet 10

2000 Neuchatel -

SWITZERLAND

Tel: +41 32 720 1111

Fax.: +41 32 724 1448

Contact your

local Masimo

Representative.

9-8 Radical-7R Pulse CO-Oximeter Operator’s Manual

9Service / Maintenance

Sales & End-User License Agreement

THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU (“PURCHASER”) AND

MASIMO CORPORATION (“MASIMO”) FOR THE PURCHASE OF THIS PRODUCT

(“PRODUCT”) AND A LICENSE IN THE INCLUDED OR EMBEDDED SOFTWARE

(“SOFTWARE”). EXCEPT AS OTHERWISE EXPRESSLY AGREED IN A SEPARATE

CONTRACT FOR THE ACQUISITION OF THIS PRODUCT, THE FOLLOWING TERMS ARE

THE ENTIRE AGREEMENT BETWEEN THE PARTIES REGARDING YOUR PURCHASE

OF THIS PRODUCT. IF YOU DO NOT AGREE TO THE TERMS OF THIS AGREEMENT,

PROMPTLY RETURN THE ENTIRE PRODUCT, INCLUDING ALL ACCESSORIES, IN THEIR

ORIGINAL PACKAGES, WITH YOUR SALES RECEIPT TO MASIMO FOR A FULL REFUND.

Warranty

Masimo warrants to the initial Purchaser for a period of one (1) year from the date of purchase

that: (i) each new Product and the Software media as delivered are free from defects in

workmanship or materials, and (ii) the Product and Software will perform substantially as labeled

in the directions for use. Masimo’s sole obligation under this warranty is to repair or replace any

Product or Software that is covered under warranty.

Batteries are warranted for six (6) months.

To request a replacement under warranty, Purchaser must contact Masimo for a returned goods

authorization. If Masimo determines that a Product must be replaced under warranty, it will be replaced

and the cost of shipment covered. All other shipping costs shall be the responsibility of Purchaser.

Exclusions

The warranty does not extend to, and Masimo is not responsible for, repair, replacement, or

maintenance needed because of: a) modification of the Product or Software without Masimo’s

written authorization; b) supplies, instruments or electrical work external to the Product or not

manufactured by Masimo; c) disassembly or reassembly of the Product by anyone other than

an authorized Masimo agent; d) use of the Product with sensors or other accessories other than

those manufactured and distributed by Masimo; e) use of the Product and Software in ways or in

environments for which they are not labeled; and f) neglect, misuse, improper operation, accident,

fire, water, vandalism, weather, war, or any act of God. This warranty does not extend to any

Product that has been reprocessed, reconditioned or recycled.

This warranty also does not apply to any Products provided to Purchaser for testing or demonstration

purposes, any temporary Products modules or any Products for which Seller does not otherwise

receive a usage or purchase fee; all such Products are provided AS-IS without warranty.

THIS WARRANTY, TOGETHER WITH ANY OTHER EXPRESS WRITTEN WARRANTY THAT

MAY BE ISSUED BY MASIMO IS THE SOLE AND EXCLUSIVE WARRANTY AS TO THE

PRODUCT AND SOFTWARE. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY ORAL OR

IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF

MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. MASIMO SHALL NOT

BE LIABLE FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL LOSS, DAMAGE OR

EXPENSE DIRECTLY OR INDIRECTLY ARISING FROM THE USE OR LOSS OF USE OF ANY

PRODUCTS OR SOFTWARE. IN NO EVENT SHALL MASIMO’S LIABILITY ARISING FROM

ANY PRODUCT AND SOFTWARE (UNDER CONTRACT, WARRANTY, TORT, STRICT LIABILITY

OR OTHER CLAIM) EXCEED THE AMOUNT PAID BY PURCHASER FOR THE PRODUCTS

GIVING RISE TO SUCH CLAIM. THE LIMITATIONS IN THIS SECTION SHALL NOT BE DEEMED

TO PRECLUDE ANY LIABILITY THAT CANNOT LEGALLY BE DISCLAIMED BY CONTRACT.

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

End-User License Agreement

Grant of License: In consideration of payment of the Software license fee, which is part of the

price paid for the Product, Masimo grants to Purchaser a nonexclusive, nontransferable (except

as set forth below) license (“License”), without right to sublicense, to use the copy of the Software

in connection with Purchaser’s use of the Product for its labeled purpose as set forth in these

directions for use. Masimo reserves all rights not expressly granted to Purchaser.

Ownership of Software: The Software is licensed not sold; all rights and interests in the Software

and all copies thereof remain at all times vested in Masimo, and do not pass to Purchaser.

Any references in this Agreement to the purchase or sale of the Software shall be deemed the

purchase or sale of a Software License as set forth herein.

Restrictions

Unauthorized copying of the Software, including Software that has been modified, merged,

or included with other software, or the written materials is expressly forbidden. Purchaser

may be held legally responsible for any copyright infringement that is caused or incurred by

Purchaser’s failure to abide by the terms of this Agreement. Nothing in this License provides

any rights beyond those provided by 17 U.S.C. §117.

Use Restrictions: Purchaser may physically transfer the Product from one location to another

provided that the Software is not copied. Purchaser may not electronically transfer the

Software from the Product to any other instrument. Purchaser may not disclose, publish,

translate, release, distribute copies of, modify, adapt, translate, reverse engineer, decompile,

disassemble, or create derivative works based on the Software or the written materials.

3. Transfer Restrictions: In no event may Purchaser transfer, assign, rent, lease, sell, or

otherwise dispose of the Product or the Software on a temporary basis. Purchaser shall

not assign or transfer this License, in whole or in part, by operation of law or otherwise

without Masimo's prior written consent; except that the Software and all of Purchaser’s

rights hereunder shall transfer automatically to any party that legally acquires title to the

Product with which this Software is included. Any attempt to assign any rights, duties or

obligations arising hereunder other than as set forth in this paragraph shall be void.

4. U.S. Government Rights: If Purchaser is acquiring Software (including the related

documentation) on behalf of any part of the United State Government, the following

provisions apply: the Software and documentation are deemed to be “commercial software”

and “commercial computer software documentation,” respectively pursuant to DFAR

Section 227.7202 FAR 12.212, as applicable. Any use, modification, reproduction, release,

performance, display or disclosure of the Software (including the related documentation) by

the U.S. Government or any of its agencies shall be governed solely by the terms of this

Agreement and shall be prohibited except to the extent expressly permitted by the terms

of this Agreement.

No Implied License

Possession or purchase of this device does not convey any express or implied license to use the

device with unauthorized sensors or cables that would, alone, or in combination with the device,

fall within the scope of one or more of the patents relating thereto. BY ACCEPTANCE OR USE

OF THIS DEVICE, YOU ACKNOWLEDGE YOUR ACCEPTANCE OF THESE TERMS.

Service / Maintenance

9-10 Radical-7R Pulse CO-Oximeter Operator’s Manual

Sensors Licensed for Monitoring Use

Only

Sensors designated for monitoring only are licensed to you under patents owned by Masimo

to be used for patient monitoring, in an unmodified form as originally received from Masimo,

and no license is granted to have Masimo’s sensors reprocessed or otherwise modified, unless

specifically authorized by Masimo. There is no license, implied or otherwise, that would allow use

of licensed sensors beyond their intended duration. After use of sensors through their designated

duration, there is no further license granted by Masimo to use the sensors and the sensors must

be discarded or returned to Masimo for reprocessing.

Service / Maintenance

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

Part Numbers

PART NUMBER DESCRIPTION

2386 REPLACEMENT BATTERY, RADICAL-7R HANDHELD

1317 RADICAL-7R POLE CLAMP

2350 RADICAL-7R HANDHELD LOCK

2351 RADICAL-7R HANDHELD LOCK KEY

2368 MASIMO SET TESTER - 20 PIN

1584 RADICAL-7R POWER CORD LOCK, 5/PACK

Please visit our website, www.masimo.com, for updated information about Masimo products.

www.masimo.com

Instruments and sensors containing Masimo Rainbow SET technology are

identified with the Masimo Rainbow SET logo.

33975/6189A-1209

Masimo RAD7CPL Radical 7R User Manual LAB 6189A indd

Masimo Corporation Radical 7R LAB 6189A indd

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