Radical 7 with Rainbow Technology Operator's Manual April 2010

Signal Extraction Pulse CO-Oximeter OPERATOR’S MANUAL

The Radical-7 Pulse CO-Oximeter Operating Instructions provide the necessary information for proper operation of all models of the Radical-7 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-7 Pulse CO-Oximeter are prerequisites for its proper use. Do not operate the Radical-7 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 EU Authorized Representative for Masimo Corporation:

EC REP MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1/CAN/CSA C22.2 No. 601.1 80fk

Covered by one or more of the following U.S. Patents: RE38492, RE38476, 7530955, 7509154, 7499741, 7496393, 7489958, 7471969, 7469157, 7467002, 7377899, 7376453, 7373194, 7355512, 7328053, 7295866, 7254433, 7221971, 7215986, 7467002, 7377899, 7376453, 7373194, 7355512, 7328053, 7295866, 7254433, 7221971, 7215986, 6699194, 6684090, 6658276, 6654624, 6650917, 6643530, 6606511, 6584336, 6515273, 6501975, 6463311, 6430525, 6388240, 6360114, 6263222, 6236872, 6229856, 6157850, 6067462, 6011986, 6002952, 5919134, 5769785, 5758644, 5685299, 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. © 2010 Masimo Corporation, Masimo, RadNet, Rainbow, SpCO, Discrete Saturation Transform, DST, DCI, FastSat, SatShare, , SET, Signal IQ, SpMet, SpHb, LNOP and LNCS are federally registered trademarks of Masimo Corporation. Radical-7, Patient SafetyNet, Radical Screen, LNOPv, APOD, 3D ALARM, SpOC, Signal Extraction Pulse CO-Oximeter, Pleth Variability Index and PVI are trademarks of Masimo Corporation.

Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual

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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-7 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.

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The Radical-7 is to be operated by qualified personnel only. This manual, accessory Directions for Use (DFU), all precautionary information, and specifications should be read before use.

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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-7 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.

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Explosion hazard. Do not use the Radical-7 in the presence of flammable anesthetics or other flammable substance in combination with air, oxygenenriched environments, or nitrous oxide.

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Electric shock hazard. Do not open the Radical-7 cover except to replace the battery of the Handheld instrument. Only a qualified operator may perform maintenance procedures specifically described in this manual. Refer servicing to Masimo for repair of this equipment.

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High intensity, extreme lights (including pulsating strobe lights) directed on the sensor may not allow the Radical-7 to obtain readings.

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The Radical-7 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.

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If patient hypoxemia is indicated, blood samples should be analyzed by laboratory devices to completely understand the patient's condition.

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The Radical-7 is NOT intended for use as an apnea monitor.

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Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect certain arrhythmias. The Radical-7 should not be used as a replacement or substitute for ECG based arrhythmia analysis.

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As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.

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Do not place the Radical-7 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. Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED)

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Patient Safety - If a sensor is damaged in any way, discontinue use immediately. Always remove the sensor from the patient and completely disconnect the patient from the Radical-7 before bathing the patient.

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Interfering Substances: Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings.

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Do not use the Radical-7 or sensors during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The Radical-7 may affect the MRI image, and the MRI instrument may affect the accuracy of the Radical-7 parameters and measurements.

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The Radical-7 can be used during defibrillation, but the readings may be inaccurate for up to 20 seconds.

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If using Radical-7 during full body irradiation, keep the sensor out of the radiation field. If the sensor is exposed to the radiation, the reading might be inaccurate or the instrument might read zero for the duration of the active radiation period.

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Do not place the Radical-7 where the controls can be changed by the patient.

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Do not place the Radical-7 on electrical equipment that may affect the Radical-7, preventing it from working properly.

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Do not expose the Radical-7 to excessive moisture such as direct exposure to rain. Excessive moisture can cause the Radical-7 to perform inaccurately or fail. Do not place containers with liquids on or near the Radical-7. Liquids spilled on the Pulse CO-Oximeter may cause it to perform inaccurately or fail. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. SpO2 is empirically calibrated to functional arterial oxygen saturation in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). The Radical-7 can not measure elevated levels of COHb or MetHb. Increases in either COHb or MetHb will affect the accuracy of the SpO2 measurement. Innacurate SpO2 readings can be caused by:

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■ Elevated levels of COHb and MetHb ■ 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. ■ Intravascular dyes such as indocyanine green or methylene blue. ■ Externally applied coloring (such as nail polish). ■ Elevated levels of Bilirubin Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual

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SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED) ■ Severe anemia ■ Low arterial perfusion ■ Motion artifact

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Inaccurate SpHb and SpOC readings can be caused by: ■

Intravascular dyes such as indocyanine green or methylene blue

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Externally applied coloring (such as nail polish)

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Elevated levels of Bilirubin

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Low arterial perfusion

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Motion artifact

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Low arterial oxygen saturation levels

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Hemoglobin synthesis disorders

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Hemoglobinopathy

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Peripheral vascular disease

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EMI radiation interference

Inaccurate SpCO and SpMet readings can be caused by: ■

Elevated levels of Bilirubin

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Motion artifact

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Low arterial oxygen saturation levels

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Do not place the Radical-7 against a surface. This can cause a system or battery (nonclinical) alarm to be muffled.

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For home use, ensure that the Radical-7'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.

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Additional information specific to Masimo sensors, including information about parameter/ measurement performance during motion and low perfusion, may be found in the sensor's Directions for Use (DFU).

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If the Radical-7 fails any part of the setup procedures or leakage tests, remove the Radical-7 from operation until qualified service personnel have corrected the situation. Do not incinerate battery. Disposal of product - Comply with local laws in the disposal of the instrument and/or its accessories. To protect against injury from electric shock, follow the directions below:

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■ 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.

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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 Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED)

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.

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To ensure safety, avoid stacking multiple instruments or placing anything on the instrument during operation.

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Cleared Use Only: The device and related accessories are cleared by the Food and Drug Administration (FDA) for noninvasive patient monitoring and may not be used for any processes, procedures, experiments or any other use for which the device is not intended or cleared by the FDA, or in any manner inconsistent with the instructions for use or labeling. This device and related accessories are not intended for use in combination with any other medical devices or in high-risk applications.

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Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual

Table of Contents

SECTION 1 - OVERVIEW About This Manual... 1-1 Warnings, Cautions and Notes... 1-2 Product Description... 1-3 Features... 1-3 Indications For Use... 1-4 Pulse CO-Oximetry... 1-4 SpO2 General Description... 1-4 SpCO General Description... 1-4 SpMet General Description... 1-4 SpHb General Description...1-5 Total Arterial Oxygen Content (CaO2) General Description...1-5 Principle of Operation... 1-5 Functional Saturation... 1-6 Radical-7 vs. Drawn Whole Blood Measurements... 1-6 Signal Extraction Technology (SET)... 1-7 SpCO, SpMet and SpHb Measurements During Patient Motion... 1-8 Masimo Rainbow SET Parallel Engines... 1-8 Masimo SET DST ®... 1-8 SECTION 2 - SYSTEM DESCRIPTION Introduction... 2-1 Radical-7 Pulse CO-Oximeter Handheld... 2-2 Handheld Front Panel... 2-2 Main Screen Trend Graph Display... 2-6 Handheld Back Panel... 2-7 Radical-7 Pulse CO-Oximeter Standalone... 2-8 Standalone Front Panel... 2-9 Standalone Back Panel... 2-10 Symbols... 2-11 Radical-7 Monitor Interface... 2-12 SECTION 3 - SETUP Introduction... 3-1 Unpacking and Inspection... 3-1 Preparation for Monitoring... 3-1 Radical-7 Docking Station Power Requirements... 3-1 Initial Battery Charging... 3-2 Initial Installation... 3-2 Monitor Setup... 3-3 Factory Default Settings... 3-3 Custom (User) Defined Settings... 3-3 Adult/Neo Settings (Pre-defined)... 3-4 SatShare Setup... 3-5 SatShare Setup... 3-5 Philips VueLink Setup... 3-7 Spacelabs Universal Flexport Setup... 3-7 Patient SafetyNet/RadNet Setup... 3-8

Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual

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Table of Contents

SECTION 4 - OPERATION Introduction... 4-1 Basic Operation... 4-1 General Setup and Use... 4-1 Successful Monitoring... 4-2 Masimo Sensors... 4-3 Numeric Display - SpO2... 4-4 Sensor Time Remaining... 4-4 Numeric Display - Pulse Rate... 4-4 Numeric Display - SpCO... 4-4 Numeric Display - SpMet... 4-4 Numeric Display - SpHb... 4-5 Numeric Display - SpOC... 4-5 Numeric Display - (PI)... 4-5 Pleth Variability Index - (PVI)... 4-5 Signal Indication and Quality Indicator (SIQ)... 4-6 Low Perfusion... 4-7 Actions To Be Taken... 4-7 Sensitivity... 4-8 Touch Key Control Button and Icons... 4-9 Traditional User Interface... 4-9 First Page... 4-9 Second Page... 4-9 Simplified User Interface... 4-10 First Page... 4-10 Second Page... 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... 4-14 Rotate Screen... 4-18 Display... 4-18 Clock... 4-20 About... 4-20 Config... 4-20 General... 4-21 3D ALARM... 4-23 Output... 4-23 Service... 4-25 Trend Display... 4-26 Trend Auto Scale... 4-26 Trend Display Screen... 4-26 Navigating the Trend Display... 4-27 Trend Setup... 4-29 Histogram... 4-30 Trend Setup and Use... 4-31 Introduction... 4-31 viii vii

Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual

Table of Contents SECTION 4 - OPERATION (CONTINUED) TrendCom Utility Installation... 4-31 TrendCom Utility Operation... 4-31 Erasing Trend Memory... 4-32 Trend Data Format... 4-32 Sample Trend Output... 4-32 Backlight Operation... 4-33 SatShare Operation... 4-33 Home Mode Operation... 4-36 Password Operation... 4-36 SECTION 5 - ALARMS AND MESSAGES Alarm Identification... 5-1 System Messages... 5-2 3D ALARM Overview... 5-5 Desat Index Alarm... 5-5 Perfusion Index (PI) Delta Alarm... 5-5 Desat Index Alarm... 5-6 User Interaction to Implement Desat Index Alarm... 5-7 Perfusion Index (PI) Delta Alarm... 5-8 User Interaction to Implement PI Delta Alarm... 5-8 3D ALARM Menu... 5-8 SECTION 6 - TROUBLESHOOTING Troubleshooting... 6-1 SECTION 7 - SPECIFICATIONS Radical-7 Specifications... 7-1 Performance... 7-1 Accuracy... 7-1 Electrical... 7-2 Environmental... 7-2 Physical Characteristics... 7-2 Serial Interface Specifications... 7-4 Serial Interface Setup... 7-4 Serial Printer Setup... 7-5 Analog Output/Nurse Call Specifications... 7-5 Analog Output... 7-6 Calibration... 7-6 Nurse Call... 7-6 SECTION 8 - SENSORS & PATIENT CABLES Introduction... 8-1 Selecting a Masimo SET Sensor... 8-1 Sensor Application Instructions... 8-1 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... 8-2 Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual

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Table of Contents

SECTION 8 - SENSORS & PATIENT CABLES (CONTINUED) Masimo SpO2 Sensors... 8-3 ReSposable Pulse CO-Oximeter Sensor System... 8-3 Red Direct Connect Sensors... 8-3 ® LNOP Reusable Sensors... 8-3 ® LNOP Adhesive Sensors... 8-3 TM LNOPv Adhesive Sensors... 8-3 ® LNOP Specialty Sensors... 8-4 ® M-LNCS™/LNCS Reusable Sensors... 8-4 ® M-LNCS™/LNCS Adhesive Sensors... 8-4 ® M-LNCS™/LNCS Specialty Sensors... 8-4 Sensor Accuracy... 8-4 Cleaning And Reuse Of Masimo Reusable Sensors and Cables... 8-4 Reattachment of Single Use Adhesive Sensors... 8-5 SECTION 9 - SERVICE AND MAINTENANCE Introduction... 9-1 Cleaning... 9-1 Battery Operation and Maintenance... 9-2 Replacing the Batteries... 9-4 Replacing the Fuses... 9-4 Performance Verification... 9-5 Service and Repair... 9-7 Repair Policy... 9-7 Return Procedure... 9-7 Warranty... 9-8 Exclusions... 9-8 Sales & End-User License Agreement... 9-9 Restrictions... 9-9 SECTION 10 - ACCESSORIES Accessories... 10-1

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Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual

Overview

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About This Manual This manual explains how to set up and use the Radical-7™ 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-7 Pulse CO-Oximeter.

SECTION 2

SYSTEM DESCRIPTION describes the Radical-7 Pulse CO-Oximeter system and its functions and features.

SECTION 3

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

SECTION 4

OPERATION describes the operation of the Radical-7 Pulse CO-Oximetry system.

SECTION 5

ALARMS AND MESSAGES describes the alarm system messages.

SECTION 6

TROUBLESHOOTING describes troubleshooting information.

SECTION 7

SPECIFICATIONS gives the detailed specifications of the Radical-7 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-7 Pulse CO-Oximeter.

SECTION 10

ACCESSORIES lists the available Radical-7 Pulse CO-Oximeter accessories.

Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual

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Overview Warnings, Cautions and Notes Please read and follow any warnings, cautions and notes presented throughout this manual. An explanation of these labels are as follows: A WARNING is provided when actions may result in a serious outcome (i.e., injury, serious adverse affect, death) to the patient or user. Look for text in a gray shaded box. Sample of Warning:

WARNING: THIS IS A SAMPLE OF A WARNING STATEMENT. A CAUTION is given when any special care is to be exercised by the patient or user to avoid injury to the patient, damage to this instrument or damage to other property. Sample of Caution: CAUTION:

THIS IS A SAMPLE OF A CAUTION STATEMENT.

A NOTE is provided when extra general information is applicable. Sample of Note: NOTE: This is a sample of a Note.

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Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual

Overview

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Product Description The Radical-7 Pulse CO-Oximeter is a noninvasive, arterial oxygen saturation, total hemoglobin concentration and pulse rate monitor. The Radical-7 Pulse CO-Oximeter can be used as either a Handheld or a Standalone monitor. The Radical-7 Pulse CO-Oximeter features a backlit Liquid Crystal Display (LCD) that continuously displays numeric values for SpO2, SpMet®, SpCO®*, SpHb®, SpOC™*, pulse rate, Perfusion Index (PI) and Pleth Variability Index (PVI). It also provides graphical displays for plethysmographic waveform, Signal Identification and Quality Indicator (Signal IQ®). The Radical-7 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-7 family: ■ Masimo SET is clinically proven to be the highest sensitivity and specificity pulse oximeter technology in the world. ■ Rainbow technology uses 7+ wavelengths of light to continuously and noninvasively measure carboxyhemoglobin (SpCO®*), methemoglobin (SpMet™*) and total hemoglobin (SpHb™*), as well as providing a more reliable probe-off detection. ■ 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. ■ Perfusion Index (PI) with trending capability indicates arterial pulse signal strength and may be used as a diagnostic tool during low perfusion. ■ *Pleth Variability Index (PVI) may show changes that reflect physiologic factors such as vascular tone, circulating blood volume, and intrathoracic pressure excursions.1 ■ Accurate on cyanotic infants with congenital heart disease when used with an LNOP® Blue Sensor. ■ Signal IQ® waveform for signal identification and quality indication during excessive motion and low signal to noise situations. ■ FastSat® tracks rapid changes in arterial O2 with high fidelity unlike any other pulse oximeter. ■ Variable pitch provides tonal variance for every 1% change in saturation. ■ 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 the Radical-7 monitor. ■ Automatic screen rotation provides upright display for vertical or horizontal monitor positioning. ■ Remote alarming interface. ■ Trend Auto Scale feature. ■ Detachable portable handheld for patient transport. ■ *3D ALARM™ ■ Desat Index Alarm™ enables clinicians to detect an increasing quantity of smaller desaturations that may precede declining respiratory status. ■ PI Delta Alarm™ alerts clinicians to possible changes in perfusion, often a reliable indicator of illness severity. 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

Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual

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Overview

INDICATIONS FOR USE The Radical-7 Pulse CO-Oximeter and accessories are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by a SpO2 sensor), carboxyhemoglobin and methemoglobin concentrations expressed in percentage (SpCO and SpMet) and total hemoglobin concentration expressed in grams per deciliter (SpHb). The Radical-7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric and neonatal patients during both motion and no motion conditions, who are well or poorly perfused patients in hospitals, hospital-type facilities, mobile and home environments.

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 fingertip for adults and the hand or foot for neonates. The sensor is connected to the Pulse CO-Oximetry instrument with a patient cable. The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data in three ways: 1.

As a percent value for arterial oxygen saturation (SpO2)

2.

As a pulse rate (PR)

3.

As a plethysmographic waveform

The following figure shows the general monitoring setup.

SpCO GENERAL DESCRIPTION

6 20 10.0 --13 -----

17 7

SpHb g/dl

3.00 ---

1. Instrument

SpOC ml/dl

2. Patient Cable 3. Sensor

Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of carbon monoxide concentration (SpCO) in arterial blood. It relies on the same basic principles of pulse oximetry (spectrophotometry) to make its SpCO measurement. The measurement is obtained by placing a sensor on a patient, usually on the fingertip for adults and the hand or foot for infants. The sensor connects either directly to the Pulse CO-Oximetry instrument or through a patient cable. The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data as percentage value for the SpCO, which reflect blood levels of carbon monoxide bound to hemoglobin.

SpMet GENERAL DESCRIPTION Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of methemoglobin concentration (SpMet) in arterial blood. It relies on the same basic principles of pulse oximetry (spectrophotometry) to make its SpMet measurement. The measurement is obtained by placing a sensor on a patient, usually on the fingertip for adults and the hand or foot for infants. The sensor connects either directly to the Pulse CO-Oximetry instrument or 1-4

Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual

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Overview

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. 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.

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). 2. The amount of arterial blood in tissue changes with your pulse (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well. The Radical-7 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-7 utilizes a sensor with various light-emitting diodes (LEDs) that pass Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual

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1 1

Overview

light through the site to a diode (detector). Signal data is obtained by passing various visible and infrared lights (LEDs, 500 to 1400nm) through a capillary bed (for example, a fingertip, a hand, a foot) and measuring changes in light absorption during the blood pulsatile cycle. This information may be useful to clinicians. The maximum radiant power of the strongest light is rated at ≤ 25 mW. The detector receives the light, converts it into an electronic signal and sends it to the Radical-7 for calculation. Absorption Spectra 4.0

Carboxyhemoglobin

3.5

Oxyhemoglobin Methemoglobin Deoxyhemoglobin

Absorption (1/mm)

3.0

Plasma

2.5 2.0 1.5 1.0 0.5 0 600

800

1000

1200

1400

1600

Wavelength (nm)

Once the Radical-7 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 SpHb measurements rely on a multiwavelength calibration equation to quantify the percentage of carbon monoxide and methemoglobin and the concentration of total hemoglobin in arterial blood. In an ambient temperature of 35º C the maximum skin surface temperature has been measured at less than 106º F (41º C), verified by Masimo sensor skin temperature test procedure.

FUNCTIONAL SATURATION The Radical-7 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. 1

2

1. 2.

Light Emitting Diodes (LEDs) (7 + wavelengths) Detector

RADICAL-7 vs. DRAWN WHOLE BLOOD MEASUREMENTS When SpO2, SpCO, SpMet and SpHb measurements obtained from the Radical-7 (noninvasive) are compared to drawn whole blood (invasive) measurements by blood gas and/or laboratory CO-Oximetry methods, caution should be taken when evaluating and interpreting the results. The blood gas and/or laboratory CO-Oximetry measurements may differ from the SpO2, SpCO, SpMet, SpHb and SpOC measurements of the Radical-7 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, 1-6

Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual

Overview

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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 and SpOC may vary with the rapid administration of fluids and in procedures such as dialysis. Additionally, drawn, wholeblood testing can be affected by sample handling methods and time elapsed between blood draw and sample testing.

SIGNAL EXTRACTION TECHNOLOGY (SET) Masimo Signal Extraction Technology's signal processing differs from that of conventional pulse oximeters. Conventional pulse oximeters assume that arterial blood is the only blood moving (pulsating) in the measurement site. During patient motion, however, the venous blood also moves, causing conventional pulse oximeters to read low values, because they cannot distinguish between the arterial and venous blood movement (sometimes referred to as noise). Masimo SET pulse oximetry utilizes parallel engines and adaptive digital filtering. Adaptive filters are powerful because they are able to adapt to the varying physiologic signals and/or noise and separate them by looking at the whole signal and breaking it down to its fundamental components. The Masimo SET signal processing algorithm, Discrete Saturation Transform® (DST®), in parallel with Fast Saturation Transform® (FST®), reliably identifies the noise, isolates it and, using adaptive filters, cancels it. It then reports the true arterial oxygen saturation for display on the monitor.

Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual

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Overview

SpCO, SpMet AND SpHb MEASUREMENTS DURING PATIENT MOTION The Radical-7 displays measurements of SpCO, SpMet and SpHb during patient motion. However, because of the changes in the physiological parameters such as blood volume, arterial-venous coupling, etc. that occur during patient motion, the accuracy of such measurements may not be reliable during excessive motion. 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.

MASIMO RAINBOW SET PARALLEL ENGINES This figure is for conceptual purposes only.

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FST

MST

SpOC

MASIMO SET DST ®

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Radical-7 Signal Extraction Pulse CO-Oximeter Operator’s Manual