Rad-87 Pulse CO-Oximeter Operator’s Manual Sept 2010

The Rad-87 Operating Instructions provide the necessary information for proper operation of all models of the Rad-87 instrument. General knowledge of pulse CO-Oximetry and an understanding of the features and functions of the Rad-87 are a prerequisite for its proper use. Do not operate the Rad-87 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

3149433

CONFORMS TO UL STD 60601-1, CERTIFIED TO CAN/CSA STD C22.2 NO. 601.1

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. Other patents pending. © 2010 Masimo Corporation. Masimo, Discrete Saturation Transform, DST, DCI, Signal Extraction Technology, Signal Extraction Pulse CO-Oximeter, SET, Rad, RadNet, Radical, , Signal I.Q., Pronto, FastSat, PVI, LNOP, Rainbow, SpCO, SpMet, SpHb, and LNCS are federally registered trademarks of Masimo Corporation. Rad-87, Pleth Variability Index, Patient SafetyNet, Rainbow SET, SpOC, APOD, Pulse CO-Oximeter, LNOPv, and M-LNCS are trademarks of Masimo Corporation.

Rad-87 Pulse CO-Oximeter Operator’s Manual

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Safety Information, Warnings, Cautions and Notes The Rad-87™ 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. ■

Explosion hazard. Do not use the Rad-87 in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide.

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

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The Rad-87 is NOT intended for use as an apnea monitor.

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The Pulse CO-Oximeter should be considered an early warning device. 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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Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect certain arrhythmias. The pulse oximeter should not be used as a replacement or substitute for ECG based arrhythmia analysis.

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The Rad-87 is to be operated by qualified personnel only. This manual, accessory directions for use, all precautionary information, and specifications should be read before use.

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Electric shock hazard. Do not open the Rad-87 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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As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.

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Use cables only from the instrument manufacturer to provide protection against the effects of discharge from a cardiac defibrillator and burns.

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Do not place the Rad-87 or accessories in any position that might cause it to fall on the patient. Do not lift the Rad-87 by the power cord or any other cable.

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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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SpO2 is empirically calibrated to functional arterial oxygen saturation in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). A pulse 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.

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■ 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® and SpOC™ measurements. Motion artifact may lead to inaccurate SpMet, SpCO, SpHb and SpOC measurements.

Rad-87 Pulse CO-Oximeter Operator’s Manual

Safety Information, Warnings, Cautions and Notes, continued ■

Very low arterial Oxygen Saturation (SpO2) levels may cause inaccurate SpCO and SpMet measurements.

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Severe anemia may cause erroneous SpO2 and SpOC readings.

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Hemoglobin synthesis disorders may cause erroneous SpHb readings.

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Do not use the Rad-87 or sensors during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The Rad-87 may affect the MRI image and the MRI device may affect the accuracy of the Pulse CO-Oximetry parameters and measurements.

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If using Rad-87 during full body radiation, 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 irradiation period.

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For home use, ensure that the Rad-87’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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Always remove the sensor from the patient and completely disconnect the patient from the Rad-87 before bathing the patient.

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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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Do not place the Rad-87 where the controls can be changed by the patient.

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Do not place the Rad-87's face against a surface. This will cause the alarm to be muffled.

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Do not place the Rad-87 on electrical equipment that may affect the Pulse CO-Oximeter, preventing it from working properly.

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Do not expose the Rad-87 to excessive moisture such as direct exposure to rain. Excessive moisture can cause the instrument to perform inaccurately or fail.

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Do not place containers with liquids on or near the Rad-87. Liquids spilled on the instrument may cause it to perform inaccurately or fail.

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If the Rad-87 fails any part of the setup procedures or leakage tests, remove the instrument from operation until qualified service personnel have corrected the situation.

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Patient Safety - If a sensor is damaged in any way, discontinue use immediately.

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Do not monitor more than a single patient at a time on the Rad-87.

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Disposal of product - Comply with local laws in the disposal of the instrument and/or its accessories.

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The Rad-87 can be used during defibrillation, but the readings may be inaccurate for up to 20 seconds. ■ This equipment has been tested and found to comply with the limits for medical devices to the EN 60601-1-2, Medical Device Directive 93/42/EEC and Part 15, FCC Rules/USA.

■ This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. ■ 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 devices 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 devices, 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 device. Rad-87 Pulse CO-Oximeter Operator’s Manual

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Safety Information, Warnings, Cautions and Notes, continued ■ Increase the separation between the equipment. ■ Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected. ■ Consult the manufacturer for help. ■

In order to connect wirelessly to a compatible interface system like Patient SafetyNet™, the Rad-87 should be placed in an environment free from RF shielding, which could hinder wireless reception.

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To minimize radio interference, other electrical equipment that emits RF transmissions should not be in close proximity to the Rad-87.

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Changes or modifications to the wireless radio feature whether intentional or unintentional are prohibited without written approval from Masimo Corporation.

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The Rad-87 (instrument with optional radio) wirelessly transmits real-time sensor connectivity status, indicating a connect and/or disconnect state. If the instrument is in a failure mode then the radio power is disabled and an error message is indicated on the instrument display. The instrument does not have a powered state where no information is transmitted.

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In accordance with FCC requirements, the Rad-87 (instrument with optional radio) must be placed greater then 20 cm from the patient's head.

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In accordance with FCC requirements, radio accessories on the Rad-87 (instrument with optional radio) cannot be attached directly to the patient using any accessory containing metal components.

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In accordance with international telecommunication requirements, the frequency band of 5,150 MHz to 5,250 MHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems.

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The battery should be adequately charged to ensure backup power in case of AC power disruption.

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A functional tester cannot be utilized to assess the accuracy of the Pulse CO-Oximeter or any sensors.

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

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Ensure the speaker is not covered or the instrument is placed face-down on bedding or other sound absorbing surface.

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To protect against injury from electric shock, follow the directions below: ■ 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 device. ■ Use cleaning solutions sparingly. 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. The device and related accessories are not intended for use in combination with other medical devices or in high-risk applications.

Rad-87 Pulse CO-Oximeter Operator’s Manual

Table of Contents Safety Information, Warnings, Cautions and Notes... ii SECTION 1 - OVERVIEW About This Manual... 1-1 Warnings, Cautions and Notes... 1-2 Product Description... 1-3 Features... 1-3 Optional 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 (Total Hemoglobin) General Description... 1-5 CaO2 (Total Arterial Oxygen Content) General Description...1-5 SpOC (Pulse CO-Oximetry) General Description... 1-5 Principle of Operation... 1-6 Functional Saturation... 1-7 Rad-87 vs. Drawn Whole Blood Measurements... 1-7 Masimo SET Signal Extraction Technology for SpO2 Measurements... 1-7 SpMet, SpCO, and SpHb Measurements During Patient Motion... 1-7 FastSat... 1-8 Masimo Rainbow SET Parallel Engines... 1-9 Masimo SET DST®... 1-9 SECTION 2 - SYSTEM DESCRIPTION Introduction... 2-1 Rad-87 Pulse CO-Oximeter - Horizontal... 2-2 Rad-87 Pulse CO-Oximeter - Vertical... 2-5 Rad-87 Rear Panel... 2-6 Symbols... 2-7 LCD Display... 2-8 SECTION 3 - SETUP Rad-87 Setup... 3-1 Introduction... 3-1 Unpacking and Inspection... 3-1 Preparation for Monitoring... 3-1 Rad-87 Power Requirements... 3-1 Initial Battery Charging... 3-2 Initial Installation... 3-2 System Interface Setup... 3-3 Philips VueLink Setup... 3-3 RadNet Setup... 3-3 Patient SafetyNet Setup... 3-3 SECTION 4 - OPERATION Introduction... 4-1

Rad-87 Pulse CO-Oximeter Operator’s Manual

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Table of Contents Basic Operation... 4-1 General Setup and Use... 4-1 Default Settings... 4-4 Factory Default and User Configurable Settings... 4-4 Successful Monitoring... 4-5 Masimo Pulse CO-Oximetry Sensors... 4-5 Sensor Time Remaining... 4-6 Liquid Crystal Display (LCD)... 4-6 Light Emitting Diodes (LED) Display... 4-9 Numeric Display - SpO2... 4-10 Numeric Display - Pulse Rate... 4-10 Numeric Display - SpCO... 4-10 Numeric Display - SpMet... 4-10 Numeric Display - SpHb... 4-11 Numeric Display - SpOC... 4-11 Numeric Display - PI... 4-11 Numeric Display - PVI... 4-11 Low Perfusion... 4-12 Signal Indication and Quality Indicator (SIQ)... 4-12 Low SpCO SIQ and Low SpMet SIQ... 4-12 Low SpHb... 4-12 Rainbow SET, Masimo SET Sensor Placement... 4-13 Sensitivity... 4-13 Low Battery Audible Alarm... 4-14 Normal Patient Monitoring... 4-14 Parameter/Measurement Selection... 4-15 Setup Menu... 4-15 Menu Navigation... 4-15 Setup Menu Level 1... 4-16 Parameter/Measurement Alarm Limits - Screen 1... 4-17 Parameter/Measurement Alarm Limits - Screen 2... 4-18 Parameter/Measurement Alarm Limits - Screen 3... 4-18 LED Brightness... 4-18 Sensitivity... 4-19 Setup Menu Level 2... 4-20 Alarm Volume... 4-20 SpO2 Alarm Delay... 4-20 Clear Trend... 4-21 Button Volume... 4-22 FastSat... 4-22 Trend Setup and Use... 4-23 Introduction... 4-23 TrendCom Utility Installation... 4-23 TrendCom Utility Operation... 4-23 Download Trend Data from Rad-87... 4-23 Erasing Trend Memory... 4-24 Setup Menu Level 3... 4-25 SpO2 Averaging Time... 4-25 SpHb Averaging... 4-26 PVI Averaging... 4-26 vi

Rad-87 Pulse CO-Oximeter Operator’s Manual

Table of Contents PI Averaging... 4-27 Rapid Desat Limit... 4-28 Alarm On/Off... 4-28 Optical Sensor Off Audible Alarm Latch... 4-29 Default Settings... 4-29 Device Profile Setup and Use... 4-30 SmartTone On/Off... 4-31 Year... 4-31 Month... 4-32 Day... 4-32 Hour... 4-32 Minute... 4-33 Software Version... 4-33 Serial Output... 4-33 Interface Alarms... 4-34 Nurse Call... 4-35 Polarity... 4-35 Line Frequency... 4-35 Parameter/Measurement Select - Screen 1... 4-36 Parameter/Measurement Select - Screen 2... 4-36 Parameter/Measurement Select - Screen 3... 4-37 SpHb Precision... 4-37 SpHb Calculation... 4-37 LCD Language... 4-38 SpHb Display... 4-38 Set Mode... 4-38 Home Mode Operation... 4-39 Sleep Mode Operation... 4-39 Enable/Disable Radio... 4-39 LCD Display Function with Radio Configured and Enabled... 4-40 SECTION 5 - ALARMS AND MESSAGES Alarm Identification... 5-1 Alarm Category Table... 5-1 Alarm Limits... 5-2 Alarm Limit: User Configurable Settings... 5-3 Alarm Priorities... 5-4 Multiple Parameter/Measurement Alarms... 5-5 Alarm Priority for Display Screens... 5-5 Alarm Silence... 5-5 Alarm Bell... 5-6 System Status Light... 5-6 Alarm Mute... 5-7 Messages... 5-8 SECTION 6 - TROUBLESHOOTING Troubleshooting... 6-1 SECTION 7 - SPECIFICATIONS Rad-87 Specifications... 7-1 Serial Interface Specifications... 7-4 Rad-87 Pulse CO-Oximeter Operator’s Manual

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Table of Contents Serial Interface Setup... 7-4 Serial Printer Setup... 7-5 Nurse Call Specifications... 7-5 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 Reusable Sensors... 8-2 Rainbow Direct Connect Sensors... 8-2 Rainbow R Series Adhesive Sensors... 8-3 Rainbow ReSposable™ Pulse CO-Oximeter Sensor System... 8-4 Masimo SpO2 Sensors... 8-4 ReSposable™ Pulse CO-Oximeter Sensor System... 8-4 Red Direct Connect Sensors... 8-4 LNOP® Reusable Sensors... 8-4 LNOPv™ Adhesive Sensors... 8-4 LNOP Specialty Sensors... 8-5 M-LNCS™/LNCS® Reusable Sensors... 8-5 M-LNCS™/LNCS® Adhesive Sensors... 8-5 M-LNCS™/LNCS® Specialty Sensors... 8-6 Sensor Accuracy... 8-7 Cleaning And Reuse Of Masimo Reusable Sensors and Cables... 8-7 Reattachment of a Single Use Rainbow SET or Masimo SET Adhesive Sensor... 8-7 SECTION 9 - SERVICE & MAINTENANCE Introduction... 9-1 Cleaning... 9-1 Battery Service... 9-2 Performance Verification... 9-2 Service and Repair... 9-3 Repair Policy... 9-3 Return Procedure... 9-4 Sales & End-User License Agreement... 9-5 Warranty... 9-5 Exclusions... 9-5 End-User License... 9-6 Restrictions... 9-7 No Implied License... 9-7 Sensors Licensed for Monitoring Use Only... 9-7 SECTION 10 - PART NUMBERS Part Numbers... 10-1

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Rad-87 Pulse CO-Oximeter Operator’s Manual

Overview

1

About This Manual This manual explains how to set up and use the Rad-87 Pulse CO-Oximeter containing Masimo Rainbow SET technology. Important safety information relating to general use of the Rad-87 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 Rad-87 Pulse CO-Oximeter.

SECTION 2

System Description describes the Rad-87 Pulse CO-Oximeter system and its functions and features.

SECTION 3

Setup describes how to setup the Rad-87 Pulse CO-Oximeter for use.

SECTION 4

Operation describes the operation of the Rad-87 Pulse CO-Oximeter 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 Rad-87 Pulse CO-Oximeter.

SECTION 8

Sensors & Patient Cables outlines how to use and care for compatible Masimo sensors and cables.

SECTION 9

Service & Maintenance describes how to maintain, service and obtain repair for the Rad-87 instrument. The Sales and End User License Agreement, including Warranty, is also in this section.

SECTION 10

Part Numbers lists the part numbers of the different language Operator's Manuals that are available for the Rad-87 Pulse CO-Oximeter.

Rad-87 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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Rad-87 Pulse CO-Oximeter Operator’s Manual

Overview

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Product Description The Rad-87 Pulse CO-Oximeter Monitor is a noninvasive, arterial oxygen, carboxyhemoglobin, methemoglobin saturation, total hemoglobin concentration, total arterial oxygen content, and pulse rate monitor. The Rad-87 features an LED display screen that continuously displays numeric values for SpO2, SpCO*, SpMet*, SpHb*, total arterial oxygen content (SpOC*), perfusion index (PI), pleth variability index* (PVI) and pulse rate . It also provides bar graph displays for quick visual identification of Signal I.Q.® (SIQ™), perfusion index (PI). The Rad-87 is available in four models: vertical Rad-87, horizontal Rad-87, vertical Rad-87 with radio and horizontal Rad-87 with radio.

Features These features are common to Rad-87 monitors: ■

Masimo SET is clinically proven to be the highest sensitivity and specificity pulse CO-Oximeter technology in the world.

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Rainbow technology continuously and noninvasively measures arterial oxygen saturation (SpO2) and pulse rate (BPM), as well as providing a reliable probe-off detection.

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Perfusion Index (PI) with trending capability indicates arterial pulse signal strength during low perfusion.

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Accurate on cyanotic infants with congenital heart disease when used with an LNOP Blue Sensor.

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Signal I.Q. provides signal identification and quality indication during excessive motion and low signal to noise situations. FastSat® tracks rapid changes in arterial O2 saturation with high fidelity.

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Variable pitch provides tonal variance for every 1% change in saturation.

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Remote alarming interface.

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Up to 72 hours of trending. (See Section 4, Trend Setup and Use.)

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Allows user to customize the default settings and set the instrument to retain these settings through a power off/on cycle.

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The LCD Display allows the user to view a scrolling marque of (installed) parameter/measurement alarm limits, system information, and wireless radio communication (wireless radio model only).

Optional Features ■

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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 reliable probe-off detection. Pleth Variability Index (PVI)† may show changes that reflect physiologic factors such as vascular tone, circulating blood volume, and intrathoracic pressure excursions.

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Total arterial oxygen content (SpOC) provides a calculated measurement of the amount of oxygen in arterial blood which may provide useful information for both oxygen dissolved in plasma and combined with hemoglobin.

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Provides an 802.11a/b/g wireless radio interface with compatible systems (wireless radio model only).

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Ability to connect to Masimo Patient SafetyNet through an optional hardwired/wireless network.

* Optional features: SpCO, SpMet, SpHb, SpOC, and PVI. † 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.

Rad-87 Pulse CO-Oximeter Operator’s Manual

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Overview Indications for Use The Masimo Rainbow SET® Rad-87 Pulse CO-Oximeter and accessories are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet) and total hemoglobin concentration.The Masimo Rainbow SET Rad-87 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals, hospitaltype facilities, mobile and home environments. Note: Please refer to the sensor Directions for Use (DFU) for specific indications. Pu ls e CO - O xi m e t ry

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 following figure shows the general monitoring setup. 1. Instrument 2. Patient Cable 3. Sensor

1

APOD

NORM MAX SENSITIVITY MODE

SIQa

97 76 12 RRa

RI rbc monitor

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SpCO General Description Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of carboxyhemoglobin 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 an instrument 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 through an instrument patient cable. The sensor collects signal data from the patient and sends it to the 1-4

Rad-87 Pulse CO-Oximeter Operator’s Manual

Overview

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instrument. The instrument displays the calculated data as percentage value for the SpMet.

SpHb (Total Hemoglobin) General Description Pulse CO-Oximetry is a continuous and noninvasive 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 adults 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. The Rad-87 can be configured to be a combined SpO2 monitor with other available parameters/measurements.

CaO2 (Total Arterial Oxygen Content) General Description* Oxygen (O2) is carried in the blood in two forms, either dissolved in plasma or combined with hemoglobin. The amount of oxygen in the arterial blood is termed the oxygen content (CaO2) and is measured in units of ml O2/dl blood. One gram of hemoglobin (Hb) can carry 1.34 ml of oxygen, whereas 100 ml of blood plasma may carry approximately 0.3 ml of oxygen. The oxygen content is determined mathematically as: CaO2 = 1.34 (ml O2/g Hb) x Hb (g/dL) x HbO2 + PaO2 (mm Hg) x (0.3 ml O2/ 100 mm Hg/dL) Where HbO2 is the fractional arterial oxygen saturation and PaO2 is the partial pressure of arterial oxygen. For typical PaO2 values, the second part of the above equation [PaO2 (mm Hg) x (0.3 ml O2/ 100 mm Hg/dL] is approximately 0.3 ml/dl. Furthermore, for typical carboxyhemoglobin and methemoglobin levels, the functional saturation (SpO2) as measured by a pulse oximeter is given by: SpO2 = 1.02 x HbO2 * Martin, Laurence. All You Really Need to Know to Interpret Arterial Blood Gases, Second Edition. New York: Lippincott Williams & Wilkins, 1999.

SpOC (Pulse CO-Oximetry) General Description The above approximations result in the following reduced equation for oxygen content via the Pulse CO-Oximeter: SpOC (ml/dl†) = 1.31 (ml O /g Hb) x SpHb (g/dL) x SpO + 0.3 ml/dl 2

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† When ml O2/g Hb is multiplied by g/dL of Hb, 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.

Rad-87 Pulse CO-Oximeter Operator’s Manual

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Overview

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Principle of Operation Pulse CO-Oximetry is governed by the following principles: 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, see figure below). 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)

2. The amount of arterial blood in tissue changes with your pulse (photoplethysography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well. The Rad-87 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 Rad-87 utilizes a sensor with various light-emitting diodes (LEDs) that pass light through the site to a photodiode (detector). See figure below. Signal data is obtained by passing various visible and infrared lights (LED’s, 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 ≤ 25mW. The detector receives the light, converts it into an electronic signal and sends it to the Rad-87 for calculation. 1

1. Light Emitting Diodes (LEDs) ( 7+ wavelengths ) 2. Detector

2

Once the Rad-87 receives the signal from the sensor, it utilizes Masimo Rainbow SET signal extraction technology to calculate the patient’s functional arterial oxygen saturation, blood levels of carboxyhemoglobin (SpCO), methemoglobin (SpMet) and pulse rate. The SpCO and SpMet measurements rely on a multiwavelength calibration equation to quantify the percentage of carbon monoxide and methemoglobin 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. 1-6

Rad-87 Pulse CO-Oximeter Operator’s Manual

Overview

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Functional Saturation The Rad-87 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.

Rad-87 vs. Drawn Whole Blood Measurements When SpO2, SpCO, SpMet and SpHb measurements obtained from the Rad-87 (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 and SpHb measurements of the Rad-87 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 elevated. 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 and SpHb 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.

Masimo SET Signal Extraction Technology for SpO2 Measurements Masimo Signal Extraction Technology’s signal processing differs from 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®) 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.

SpMet, SpCO, and SpHb Measurements During Patient Motion The Rad-87 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. When the Rad-87 does not have confidence in the value of a parameter due to poor signal quality caused by excessive motion or other signal interference, the measurement for the parameter will alternate with "---".

Rad-87 Pulse CO-Oximeter Operator’s Manual

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Overview FastSat FastSat enables rapid tracking of arterial oxygen saturation changes. Arterial oxygen saturation data is averaged using pulse oximeter averaging algorithms to smooth the trend. When the Rad87 is set to FastSat “On”, the averaging algorithm evaluates all the saturation values providing an averaged saturation value that is a better representation of the patient’s current oxygenation status. With FastSat, the averaging time is dependent on the input signal.

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Rad-87 Pulse CO-Oximeter Operator’s Manual

Overview

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Masimo Rainbow SET Parallel Engines This figure is for conceptual purposes only.

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FST

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SpOC

Masimo SET DST®

Rad-87 Pulse CO-Oximeter Operator’s Manual

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System Description

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Intro d u ct io n The Rad-87 Pulse CO-Oximeters are full featured devices designed for ease of operation. All pulse CO-Oximetry measurement information, as well as instrument status data, is displayed on the front panel of the device. All user input is handled by control buttons on the front panel. The sensor cable connections are located on the left side of the front panel for the Rad-87 horizontal instrument and the bottom of the front panel for the Rad-87 vertical device. ■

Rad-87 offers full Masimo SET technology in a small compact device.

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Rad-87 supports the full line of Masimo sensors and patient cables (see Section 8, Sensors and Patient Cables).

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Rad-87 supports standardization of sensors, and pulse CO-Oximetry technology throughout the hospital.

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The LCD Display identifies system settings, monitoring modes, alarm limits and information from Patient SafetyNet or Philips VueLink (when connected). The LCD is located on top of the instrument (Horizontal) or on the left of the instrument (Vertical).

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System Description R ad - 8 7 P u ls e C O - O x i me te r - Ho r i zo n t a l 1

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DISPLAY DISPLAY

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CONTROL / INDICATOR

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Device Profile LED

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Sensitivity Button/Indicator

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LCD Display

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ENTER ENTER

Rad-87 Rad-87 rbc monitor

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DESCRIPTION The Device (instrument) Profile LED illuminates when the instrument has been set to user configured "default" settings. Upon power up, the user configured default settings are retained and the Device Profile LED remain lit. When user configured default settings are active, any changes to the default settings cause the Device Profile LED to turn off until the instrument is returned to the user configured default settings or powered off. Used to set the instrument into Maximum Sensitivity, Normal Sensitivity, or APOD Mode.

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The LCD display identifies system settings, monitoring modes, alarm limits, and information from Patient SafetyNet or Philips VueLink (when connected).

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Signal I.Q. Index

The Signal I.Q. provides an indication of the quality of the acquired signal as well as the timing of the pulse. A green vertical LED bar rises and falls with the pulse, where the height of the bar indicates the quality of the signal.

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Perfusion Index

The Perfusion Index provides an indication of the percentage of pulsatile signal to non pulsatile signal.

Rad-87 Pulse CO-Oximeter Operator’s Manual