Pronto Pulse CO-Oximeter Operators Manual Dec 2011

These operating Instructions intend to provide the necessary information for proper operation of the Masimo Pronto® Pulse CO-Oximeter. General knowledge of Pulse CO-Oximetry and an understanding of the features and functions of the Masimo Pronto Pulse CO-Oximeter are prerequisites for proper use. Do not operate the Masimo Pronto Pulse CO-Oximeter without completely reading and understanding these instructions. NOTICE Purchase or possession of this device does not carry any express or implied license to use with replacement parts which would, alone or in combination with this device, fall within the scope of one of the relating patents. CAUTION: FEDERAL LAW (U.S.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. For further information contact: 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

80fk

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

Covered by one or more of the following U.S. Patents: 5482036, 5490505, 5632272, 5685299, 5758644, 5769785, 5919134, 6002952, 6011986, 6067462, 6157850, 6229856, 6236872, 6263222, 6360114, 6388240, 6430525, 6463311, 6501975, 6515273, 6606511, 6643530, 6650917, 6654624, 6684090, 6699194, 6745060, 6816741, 6826419, 6850787, 6861639, 6979812, 7186966, 7215984, 7215986, 7221971, 7254433, 7295866, 7328053, 7373194, 7376453, 7377899, 7467002, 7469157, 7471969, 7489958, 7496393, 7499741, 7509154, 7530955, RE38476, RE38492, international equivalents, or one or more of the patents referenced at www.masimo.com/ patents.htm. Other patents pending. Masimo, , Discrete Saturation Transform, DST, DCI, Signal Extraction Technology, SET, Radical, Signal IQ, FastSat, SpHb and Rainbow are federally registered trademarks of Masimo Corporation SIQ, APOD, and Pulse CO-Oximeter are trademarks of Masimo Corporation Printed in USA © 2011 Masimo Corporation

Non-Invasive Total Hemoglobin (SpHb) Accuracy Compared to Invasive Laboratory Methods* In 3519 comparisons of non-invasive total hemoglobin (SpHb) and invasive hemoglobin (tHb) measurements from a laboratory CO-Oximeter, SpHb accuracy was as follows: ■■ 0.91 correlation ■■ 0.8 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, 99% of SpHb readings were within 2 g/dL of the laboratory value * Masimo FDA Submission Data CONTRAINDICATIONS: The Pronto is contraindicated for use as an apnea monitor. The Pronto is also contraindicated for use as a continuous monitor.

Safety Information, Warnings and Cautions The Pronto 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. ■■ The Pronto is to be operated by qualified personnel only. This manual, accessories, Directions for Use, all precautionary information, and specifications should be read before use. ■■ 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, Pronto 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 Pronto in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. ■■ Electric shock hazard. Do not open the Pronto instrument. Only a qualified operator may perform maintenance procedures specifically described in this manual. Refer servicing to Masimo for repair of this equipment. ■■ High intensity extreme lights (including pulsating strobe lights and direct sunlight) directed on the sensor, may not allow the Pronto to obtain readings. ■■ EMI radiation interference such as computer displays and/or LCD/plasma TVs can cause errors or incorrect measurements on the Pronto. ■■ The Pronto should be considered an early warning device. For measurements of high or low SpHb readings, blood samples should be analyzed by laboratory instruments to completely understand the patient’s condition. ■■ If patient hypoxemia is indicated, blood samples should be analyzed by laboratory devices to completely understand the patient’s condition. ■■ Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect certain arrhythmias. The Pronto should not be used as a replacement or substitute for ECG based arrhythmia analysis. ■■ As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. ■■ Do not place the Pronto or accessories in any position that might cause it to fall on the patient. Do not lift the Pronto by the cable or sensor.

Masimo Pronto Pulse CO-Oximeter Operator’s Manual

Safety Information, Warnings and Cautions, continued

■■ 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 Pronto before bathing the patient. ■■ Interfering Substances: Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings. ■■ Do not use the Pronto or sensors during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The Pronto may affect the MRI image and the MRI device may affect the accuracy of the Pulse CO-Oximetry parameters and measurements. ■■ Do not use the Pronto during electrocautery. ■■ Do not use the Pronto or sensors during defibrillation. ■■ If using Pronto 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 device might read zero for the duration of the active irradiation period. ■■ Do not place the Pronto where the controls can be changed by the patient. ■■ Do not place the Pronto on electrical equipment that may affect the Pronto, preventing it from working properly. ■■ Do not expose the Pronto to excessive moisture such as direct exposure to rain. Excessive moisture can cause the device to perform inaccurately or fail. ■■ Do not place containers with liquids on or near the Pronto. Liquids spilled on the device 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 Pulse CO-Oximeter cannot measure elevated levels of COHb or MetHb. Increases in either COHb or MetHb will affect the accuracy of the SpO2 measurement. ■■ Inaccurate SpO2 readings can be caused by: ❚❚ 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)

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Masimo Pronto Pulse CO-Oximeter Operator’s Manual

Safety Information, Warnings and Cautions, continued

❚❚ Elevated levels of bilirubin ❚❚ Severe anemia ❚❚ Low arterial perfusion ❚❚ Motion artifact ■■ Inaccurate SpHb readings can be caused by: ❚❚ Intravascular dyes such as indocyanine green or methylene blue. ❚❚ Externally applied coloring (such as nail polish) ❚❚ Elevated levels of bilirubin ❚❚ Low arterial perfusion ❚❚ Motion artifact ❚❚ Low arterial oxygen saturation levels including altitude induced hypoxemia ❚❚ Hemoglobin synthesis disorders ❚❚ Hemoglobinopathy ❚❚ Thalassemias ❚❚ Peripheral vascular disease ❚❚ EMI radiation interference ■■ Do not place the Pronto face against a surface. This can cause the a system or battery (nonclinical) alarm to be muffled. ■■ 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).. ■■ Always use the Pronto precisely in accordance with the directions in this manual. ■■ If the Pronto fails any part of the setup procedures or leakage spot check, remove the instrument from operation until qualified service personnel have corrected the situation. ■■ Use the Pronto in accordance with Section 7, Specifications: Environmental in this manual. ■■ Do not incinerate battery. ■■ To protect against injury from electric shock, follow the directions below: ■■Avoid placing the device on surfaces with visible liquid spills. ■■Do not soak or immerse the device in liquids. ■■Use cleaning solutions sparingly. ■■ 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 has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential 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 radio communications. However, there is Masimo Pronto Pulse CO-Oximeter Operator’s Manual

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no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, 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 antenna. ❚❚ Increase the separation between the equipment and receiver. ❚❚ Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. ❚❚ Consult the dealer or an experienced radio/TV technician for help. ■■ 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 ■■ This equipment has been tested and found to comply with the limits for medical devices to the EN 60601-1-2: 2002, Medical Device Directive 93/42/EEC and Class B. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. ■■ A functional tester cannot be utilized to assess the accuracy of the Pronto or any sensors. ■■ 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. ■■ Disposal of product - Comply with local laws in the disposal of the instrument and/or its accessories. ■■ This Class B digital apparatus complies with Canadian ICES-003.

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Masimo Pronto Pulse CO-Oximeter Operator’s Manual

Table of Contents Non-Invasive Total Hemoglobin (SpHb) Accuracy Compared to Invasive Laboratory Methods... i Safety Information, Warnings and Cautions... i

Section 1 - Overview About this Manual...1-1 Warnings, Cautions and Notes...1-2 Product Description...1-3 Features and Benefits...1-3 Indications for Use...1-3 Pulse CO-Oximetry...1-4 SpO2 General Description...1-4 SpHb General Description...1-4 Principle of Operation...1-5 Functional Saturation...1-6 Pronto vs. Drawn Whole Blood Measurements...1-6 Signal Extraction Technology (SET)...1-6 SpHb Measurements During Patient Motion...1-6 Masimo SET Parallel Engines...1-7 Masimo SET DST®...1-7

Section 2 - System Description Introduction ...2-1 Front Panel Controls ...2-1 Rear Panel...2-3 Symbols...2-4

Section 3 - Setup Introduction...3-1 Unpacking and Inspection...3-1 Preparation for Spot Checking...3-1 Power Requirements...3-1 Device Setup...3-2 Initial Setup...3-2

Section 4 - Operation Introduction...4-1 Basic Operation...4-1 General Setup and Use...4-1 Default Settings...4-2 Successful SpHb Spot Check...4-3 Masimo Sensors...4-3 Numeric Display - SpHb...4-3 Numeric Display - SpO2...4-4 Numeric Display - Pulse Rate...4-4 Numeric Display - PI...4-4 Low Perfusion...4-4 Low Signal IQ (Low SIQ) ...4-5 Troubleshooting Sensor Placement...4-5 Low Battery Audible Alarm...4-6 Masimo Pronto Pulse CO-Oximeter Operator’s Manual

Overview

Alarm Identification...4-6 Battery Level Indicator...4-6 Setup Menu...4-7 Menu Navigation...4-7 Trend Setup and Use...4-10 Introduction...4-10 TrendCom Utility Operation...4-10 Erasing Trend Memory...4-11 Trend Data Format...4-11 Sample Trend Output...4-11

Section 5 - Messages Messages...5-1

Section 6 - Troubleshooting Troubleshooting...6-1

Section 7 - Specifications Specifications...7-1

Section 8 - Sensor and Patient Cables Introduction...8-1 Selecting a Rainbow SpHb Sensor Only...8-1 Masimo Rainbow® Sensors...8-2 SpHb Rainbow Reusable and Adhesive Sensors...8-2 Sphb Rainbow Resposable Pulse Oximeter Sensor System...8-3 Sensor Accuracy...8-3 Cleaning and Reuse of Masimo Reusable Sensors and Cables...8-3

Section 9 - Service and Maintenance Introduction...9-1 Cleaning...9-1 Battery Replacement...9-2 Performance Verification...9-2 Power-On Self-Test...9-2 Service and Repair...9-3 Repair Policy...9-3 Return Procedure...9-3 Sales & End-User License Agreement...9-4 Warranty...9-4 Exclusions...9-4 End-User License...9-5 Restrictions...9-5

Section 10 - Accessories Accessories...10-1

Masimo Pronto Pulse CO-Oximeter Operator’s Manual

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Overview About this Manual This manual explains how to set up and use the Masimo Pronto Pulse CO-Oximeter. Important safety information relating to general use of the device 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 device. In addition to the safety section, this manual includes the following sections: ■■ Section 1

Overview

■■ Section 2 System Description ■■ Section 3 Setup ■■ Section 4

Operation

■■ Section 5

Messages

■■ Section 6

Troubleshooting.

■■ Section 7

Specifications

■■ Section 8

Sensors and Patient Cables

■■ Section 9

Service and Maintenance

■■ Section 10

Accessories

Masimo Pronto Pulse CO-Oximeter Operator’s Manual

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Overview

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

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Overview Product Description The Pronto Handheld Spot Check Pulse CO-Oximeter with Masimo Rainbow® SET® Technology is developed to simultaneously and non-invasively measure total hemoglobin (SpHb), functional arterial oxygen saturation (SpO2), pulse rate (PR) and perfusion index (PI).

Features and Benefits Single-Button Operation Simply connect the sensor to the device, properly align the sensor on the finger and press the “SpHb” button. Accurate and non-invasive functional arterial oxygen saturation (SpO2) and pulse rate (PR) The Pronto uses multiple wavelengths of light and proprietary algorithms to obtain functional arterial oxygen saturation (SpO2) and pulse rate (PR) readings. Accurately and non-invasively measures and displays total hemoglobin (SpHb) The Pronto measures total hemoglobin (SpHb) using similar principles as pulse oximetry with additional wavelengths of light to obtain the measurements. Clinically proven Masimo SET (Signal Extraction Technology) performance Clinically proven accurate in excessive motion and low perfusion environments. Additional Features: ■■ Signal I.Q.® (SIQ™) for signal identification and quality indication ■■ Lightweight, ergonomic handheld design ■■ Bright, multicolored lights and display ■■ Sensor life indicator shows approximate sensor uses remaining ■■ Progress indicator shows progress to completion of spot check ■■ Parameter/Measurement Select: “Up/Down” allows user to determine values to display ■■ Automatic shutdown power conservation

Indications for Use The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories are indicated for use by trained personnel, with adult and pediatric individuals during both no motion and motion conditions and for individuals who are well or poorly perfused and in clinical and non-clinical settings (e.g., hospitals, hospital-type facilities, home, clinics, physician offices, blood donation facilities and ambulatory surgery centers).

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Overview

Pulse CO-Oximetry

SpO2 General Description

Pulse oximetry is a noninvasive method of measuring the level of functional arterial oxygen saturation in blood. The measurement is taken by placing a sensor on a patient, usually on the fingertip for adults and pediatric patients. The sensor connects to the pulse oximetry device directly 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 a percent value for functional arterial oxygen saturation (SpO2).

1. Instrument 2. Sensor

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SpHb General Description Pulse CO-Oximetry instruments offer a noninvasive method of measuring the levels of total hemoglobin (SpHb) in blood. It relies on the same principles as pulse oximetry to make the SpHb measurement. The measurements are taken by placing a sensor (2) on a patient, usually on the fingertip for adults as shown in the figure above. The sensor connects directly to the instrument (1). 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.

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Overview Principles 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

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Oxyhemoglobin Methemoglobin

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2. Graphic, TheLED/Photo amount of arterial blood in tissue changes with a person’s pulse Detector Placment Adobe Illustrator 10.0 (.eps) (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of blood changes as well.

The Pronto uses a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated blood and blood plasma. The Pronto utilizes a sensor with various light-emitting diodes (LEDs) that pass light through the site to multiple photodiodes (detectors) (see figure below). 1

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

Signal data is obtained by passing various visible and infrared lights (500nm to 1300nm) through a capillary bed (for example, a fingertip) 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 detectors receive the light, convert it into an electronic signal and sends it to the Pronto for calculation. Once the Pronto receives the signal from the sensor, it utilizes Masimo Rainbow SET signal extraction technology to calculate the patient’s functional oxygen saturation, (SpO2%), total hemoglobin concentration (SpHb [g/dl]) and pulse rate (PR). The SpHb measurement relies on a multiwavelength calibration equation to quantify the percentage of total hemoglobin in blood. In an ambient temperature of 95ºF (35º C) the maximum skin surface temperature has been measured

CONFIDENTIAL AND PROPRIETARY © 2004 Masimo Corporation All Rights Reserved

Masimo Pronto Pulse CO-Oximeter Operator’s Manual

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Overview at less than 106º F (41º C), verified by Masimo sensor skin temperature test procedure.

Functional Oxygen Saturation The Pronto is calibrated to measure and display functional oxygen saturation (SpO2): the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen. See the Safety information, Warnings and Cautions section in front of this manual for details.

Pronto vs. Drawn Whole Blood Measurements When SpO2 and SpHb measurements obtained from the instrument (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 and SpHb measurements of the Pronto 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. High levels of bilirubin may cause erroneous SpO2 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 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.

Signal Extraction Technology (SET) 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.

SpO2 and SpHb Measurements During Patient Motion

SpO2 and SpHb measurement accuracy may not be reliable during excessive motion because of the changes in the physiological parameters such as blood volume, arterial-venous coupling, etc. that occur during patient motion. When the Pronto does not have confidence in the value of a parameter due to poor signal quality caused by excessive motion or other signal interference, the Low SIQ LED will illuminate. See Section 4, Low Signal IQ (Low SIQ).

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Overview Masimo SET Parallel Engines

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Masimo SET DST® �

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System Description

Introduction GRAPHIC DOCUMENTATION AND The Pronto is a spot check Pulse CO-Oximeter which includes non-invasive total hemoglobin GRAPHIC DOCUMENTATION AND APPROVAL APPROVAL GRAPHIC DOCUMENTATION AND APPROVAL GRAPHIC AND APPROVAL (SpHb) measurement. The device is designed for accuracy and ease ofDOCUMENTATION operation. All hemoglobin GR-10887 GRAPHIC DOCUMENTATION AND APPROVAL Approvals pulse oximetry measurement information, as well as device status data, is displayed on the front Approvals Approvals DRO-8890 Approvals Communications Approvals Date Marketing Communications panel of the device. All user input is handled by control buttons on the Date front panelApprovals andMarketing the sensor GR-10887 GRAPHIC DOCUMENTATION AND APPROVAL GRAPHIC DOCUMENTATION AND APPROVAL Approvals DateGR-10887 Marketing Communications Approvals Michelle Diaz 2/4/04 Approvals Date Marketing Communications Michelle Diaz 2/4/04 cable connection is located at the top edge of the device. GR-10887 DRO-8890 Michelle Diaz 2/4/04 GRAPHIC DOCUMENTATION AND APPROVAL DRO-8890 Approvals Date Marketing Communications Michelle Diaz 2/4/04 Date Document The Pronto isMichelle powered by 4 AA alkalineApprovals batteries to provide the capacityDRO-8890 of up to 8 hours of Document Title Program Diaz 2/4/04 Approvals Title Program Number Document Number Title Progra Document Number Approvals Date Marketing Communications Date Title Program continuous use, whenGRAPHIC fully charged. Continous useAND is defined ascallouts consecutive spot check tests Approvals Date Marketing Communications Date Approvals Number GR-10887 Illustration, for tables, 2/04 Adobe GR-10887 DOCUMENTATION APPROVAL GR-10887 Illustration, callouts for tables, 2/04 Adobe IlIl Document GR-10887 Illustration, callouts for tables, 2/04 Adobe I Michelle Diaz 2/4/04 Title Program Michelle Diaz spot check 2/4/04 Approvals Date test initiated Marketing Communications Date with eachNumber consecutive immediately uponcallouts the conclusion GR-10887 Illustration, for tables, 2/04 of the previous Adobe Il DRO-8890 Michelle Diaz 2/4/04 GR-10887 Illustration, callouts for tables, 2/04 Adobe Illustrator 10.0 (.eps) spot check test. Title Document Document Program Approvals Title Program Number Number Document A spot check sensor or patient cable attaches to the connector on theIllustrator top of10.0 the(.eps) Pronto. Approvals Date Marketing Communications Date Title Program GR-10887 Illustration, Adobe GR-10887 Illustration, callouts callouts for for tables, tables, 2/04 2/04 Adobe Illustrator 10.0 (.eps) Number Michelle Diaz 2/4/04 GR-10887 Illustration, callouts for tables, 2/04

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DRO-8890

GR-10887 DRO-8890 DRO-8890

GRAPHIC DOCUMENTATION AND APPROVAL Approvals Date Approvals Date Approvals Date Michelle Diaz 2/4/04 Michelle Diaz 2/4/04 Michelle Diaz 2/4/04 Approvals Date Document Michelle Diaz 2/4/04 Title Number Document Document Title Title Number Number GR-10887 Illustration, callouts for tables, 2/04 Document Title GR-10887 Illustration, GR-10887 Illustration, callouts callouts for for tables, tables, 2/04 2/04 Number

Approvals Approvals Approvals Marketing Communications Marketing Communications Communications Marketing Approvals

2

DRO-8890

Date Date Date

S y s t e mDate D e s c r i p t i o n

Marketing Communications

Program Program Program Adobe Illustrator 10.0 (.eps) Program Adobe Adobe Illustrator Illustrator 10.0 10.0 (.eps) (.eps)

Fron t P a for ntables, e l2/04C o n t r o l s , Adobe co n t10.0 in ued Illustration, callouts Illustrator (.eps)

GR-10887

1 1 1 1 2 2 2 2

DESCRIPTION CONTROL /6INDICATOR 11 16 21 6 11 16 21 Parameter/ 6 11 16 21 Displays parameter/measurement numeric values once a spot 6 11 16 21 Measurement check test is complete. Numeric Display 7

7 7 Pulse Indicator 7

12 Flashes with 17 22 (PR) during spot check test patient's pulse reading 12 17 22 12 17 22 period. 12 17 22

Incrementally illuminates upward after a SpHb spot check has

GR-10887 GRAPHIC AND Spot Check towards completion of a GR-10887 3 DOCUMENTATION 8 Progress 13 been initiated. 18This indicates progress 23 GRAPHIC DOCUMENTATION AND APPROVAL APPROVAL GR-10887 GRAPHIC AND APPROVAL 3 8 13 18 23 3 DOCUMENTATION 8 13 18 23 3

Indicator

8

DRO-8890 SpHb spot check. A fully illuminated spot check progress indicator DRO-8890

13 indicates a competed 18DRO-8890 23 spot check.

Approvals Approvals Approvals GR-10887 GRAPHIC DOCUMENTATION AND APPROVAL Approvals Approvals Date Marketing Communications Communications Date Approvals Date Marketing Communications Date Approvals Date Marketing Date 4 9 Marketing Communications 14 19 Approvals Date Date DRO-8890 ichelle Diaz 2/4/04 ichelle Diaz 2/4/04 ichelle Diaz 4 2/4/04 9 14 19 4 9 14 19 ichelle Diaz 2/4/04 Approvals 4 9 14 19 nt nt nt Title Title Program Approvals Date Marketing Communications Program Date Title Program nt Title Program chelle Diaz 2/4/04 7 Illustration, callouts for tables, 2/04 Adobe Illustrator 7 Illustration, callouts callouts for for tables, tables, 2/04 2/04 Adobe Illustrator Illustrator 10.0 10.0 (.eps) (.eps) 7 Illustration, Adobe 10.0 (.eps) 5 10 15 20 7 Illustration, callouts for tables, 2/04 Adobe Illustrator 10.0 (.eps) 5 10 15 20 5 10 15 20 t Title Program

7

1 1 1

1 2 2 2

5

Parameter/ Measurement Label Display

24 label once a spot check test is Displays parameter/measurement 24 24 complete.

Power On / Off

Powers the instrument on or off. Press the button once to power on. 25 Press and hold the button for 225 seconds to power off. 25

Illustration, callouts for tables, 2/04

6 6 6

10

Battery 11 Level Indicator11 11

CONFIDENTIAL AND PROPRIETARY © 2001 Masimo Corporation CONFIDENTIAL CONFIDENTIAL AND AND PROPRIETARY PROPRIETARY All Rights Reserved © © 2001 2001 Masimo Masimo Corporation Corporation All Rights Rights Reserved Reserved CONFIDENTIAL AND PROPRIETARY All

15

20

24

25

Adobe Illustrator (.eps) Battery charge10.0 level is indicated by four LED indicators. All four 16 21 indicators will be lit 16 21 when the batteries are full, with fewer indicators 16 being lit as the 21batteries lose their charge. Page 1 of 1 FRM 1379 Rev A Page Page 1 1 of of 1 1 DRO 5201 FRM FRM 1379 1379 Rev Rev A A

DRO Page of 1 6 11 16 21 DRO15201 5201 © 2001 Masimo Corporation FRM 1379 Rev A Patient Cable /Sensor 17 The Patient Cable/Sensor connector is where a compatible sensor 7 12 22 7 12 17 22 All Rights Reserved DRO 5201 7 12 17 is connected 22 to the Pronto. Connector

2 3 3 3

7 8 8 8

Low SIQ13 Indicator 13

12

3 4 4 4

8 9 9 9

13 18 23 remaining for 24 the attached sensor. The bottom LED will turn red 14 19 14 19 24 14 Indicator 19 when the remaining 24 uses for the connected sensor are low. The Sensor Use

13

17 SIQ is a signal 22identification and quality indicator. When this 18 23 18 indicator illuminates, 23 re-checking the measurement is necessary. 18 23

This illuminates to display the approximate number of uses

GR-10887 GR-10887 approximate number of sensor uses remaining is displayed upon DRO-8890 DRO-8890 sensor is attached) and when a sensor is connected. 4 9 14 19 power up (if a24 Approvals 5 10 15 20 25 Approvals 5 10 15 20 Press to initiate 25total hemoglobin (SpHb) spot check information 5 Date 10 15 20 25 MarketingCommunications Communications Date Date Marketing Date on display or to display a Total Hemoglobin (SpHb) spot check test. 2/4/04 2/4/04 Oxygen saturation (SpO2), perfusion index (PI) and pulse rate 5 10 15 20 25 SpHb Button (PR) are automatically displayed. When in the configuration menu, Program Program pressing this button confirm a menu setting and navigate to the TIAL AND PROPRIETARY Page 1will of 1 uts tables, 2/04 AdobeIllustrator Illustrator10.0 10.0(.eps) (.eps) TIAL AND PROPRIETARY Page uts for for tables, 2/04 Adobe TIAL AND PROPRIETARY Page 1 1 of of 1 1 mo FRM Rev mo Corporation Corporation FRM 1379 1379 Rev A TIAL AND PROPRIETARY Page 1 ofA 1 Section 4, Operation). mo Corporation FRM 1379 Rev A next menu option. (See served DRO served DRO 5201 5201

C ANDAPPROVAL APPROVAL C DOCUMENTATION DOCUMENTATION AND

mo Corporation served served

FRM 1379 A DRORev 5201 DRO 5201

66served

IAL AND PROPRIETARY mo Corporation

11

Up/Down Arrow 16 16 Buttons

Use the Up and Down arrow buttons to scroll between parameter or Page 1 of 1 1379check Rev A measurementFRM spot results. When in the configuration menu, DRO 5201 21 21 use the Up and Down arrow buttons to scroll through menu setting options. (See Section 4, Operation.)

77

12

17 Speaker17

22 22

13

18 18

23 23

88 2-2

Provides audible indication of alarm conditions, pulse tone, and feedback for control button presses.

Masimo Pronto Pulse CO-Oximeter Operator’s Manual

System Description

2

Rear Panel

Masimo Corporation Irvine, CA 92618 USA Rx Only

Masimo Corporation Irvine, CA 92618 USA

Rad-57 80 FK UL 60601-1

Rx Only

Rad-57 80 FK UL 60601-1

Masimo, SET, , and SIQ are registered trademarks of Masimo Corporation. Rad-57 is a trademark of Masimo Corporation. Rainbow and SpCO are registered trademarks of Masimo Laboratories. Signal Extraction Pulse CO-Oximeter and SpMet are trademarks of Masimo Laboratories.

GRAPHIC DOCUMENTATION AND APPROVAL GRAPHIC GRAPHIC DOCUMENTATION DOCUMENTATION AND AND APPROVAL APPROVAL

Approvals Approvals Approvals Approvals Michelle Michelle Diaz Diaz Michelle Michelle Diaz Diaz Document Document Number Document Document Number Number Number GR-10887 GR-10887 GR-10887 GR-10887

Date Date Date Date 2/4/04 2/4/04 2/4/04 2/4/04

Approvals Approvals Approvals Approvals Marketing Marketing Communications Communications Marketing Marketing Communications Communications

Title Title Title Title Illustration, Illustration, callouts callouts for for tables, tables, 2/04 2/04 Illustration, Illustration, callouts callouts for for tables, tables, 2/04 2/04

GR-10887 GR-10887 GR-10887 DRO-8890 DRO-8890 DRO-8890

Date Date Date Date

Program Program Program Program Adobe Illustrator Illustrator 10.0 Adobe 10.0 (.eps) (.eps) Adobe Adobe Illustrator Illustrator 10.0 10.0 (.eps) (.eps)

Pronto

CONTROL / INDICATOR 1 1 1

6 Serial Number Label

6 6

11 11 11

16 16 16

21 21 21

2 2 2

7 7 Label Certification

7

12 12 12

17 17 17

22 22 22

3 3 3

8 8 Battery Cover 8

13 13 13

18 18 18

23 23 23

4 4 4

Battery Cover 9 9 Release 9

14 14 14

19 19 19

24 24 24

5 5 5

10 10 10

15 15 15

20 20 20

25 25 25

CONFIDENTIAL AND PROPRIETARY CONFIDENTIAL AND PROPRIETARY © 2001 Masimo Corporation CONFIDENTIAL AND CONFIDENTIAL AND PROPRIETARY PROPRIETARY © 2001 Masimo Corporation All Rights Reserved © 2001 Masimo Corporation © Masimo Corporation All2001 Rights Reserved All All Rights Rights Reserved Reserved

Masimo Pronto Pulse CO-Oximeter Operator’s Manual

Page 1 of 1 Page 1 of 1 FRM 1379 Page 1 1 Page Rev 1 of ofA 1 FRM 1379 Rev A DRORev 5201 FRM A FRM 1379 1379 A DRORev 5201 DRO DRO 5201 5201

2-3

System Description

2

Symbols The following symbols may be found on the Pronto or packaging and are defined below: SYMBOL

DESCRIPTION Caution, consult accompanying documents Type BF applied part complying with IEC 60601-1 WEEE Compliant

Mark of Conformity to European Medical Device Directive 93/42/EEC

Rx Only

Federal law (USA) restricts this device to sale by or on the order of a physician

+70 C

-40 C +1060 hPa - +500 hPa 795 mmHg - 375 mmHg

NON STERILE

Year of manufacture Storage humidity range: 5% to 95%

5%-95% RH

EE Symbol

+70 C

LATEX

-40 C +1060 hPa - +500 hPa 795 mmHg - 375 mmHg

Storage temperature range: +70˚C to -40˚C Storage altitude range: 500 mbar to 1060 mbar

95%

or reference only; do not print.

% 5%

NON STERILE

5%-95% RH

LATEX

hics, Sensor/Cable symbols, 03/06

4

Keep dry Fragile/breakable, handle with care

95%

%

Title: symbol, art, keep dry PCX-1044

5%Revision: A

EC

REP

EU authorized representative

DRO-4150

04

Title: Graphics, Sensor/Cable symbols, 03/06 GR-14231 DRO-13914 Title: symbol, art, fragile PCX-1045 Revision: A DRO-4150

2-4

Underwriter's Laboratories Inc. certification

Masimo Pronto Pulse CO-Oximeter Operator’s Manual