Pronto Pulse CO-Oximeter Operators Manual April 2010

Pronto

OPERATOR’S MANUAL

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 30175 Hannover, Germany Tel.: +49-511-62 62 86 30 Fax.: +49-511-62 62 86 33

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: 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. Products containing Satshare® feature are also covered by U.S. Patent 6,770,028. Other patents pending. Printed in USA © 2009 Masimo Corporation. Masimo, Discrete Saturation Transform, DST, DCI, Signal Extraction Technology, SET, Radical, , Signal IQ, SIQ, FastSat, and Rainbow are federally registered trademarks of Masimo Corporation SIQ, APOD, SpHb and Pulse CO-Oximeter are trademarks of Masimo Corporation.

Masimo Pronto 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 Masimo Pronto Pulse CO-Oximeter™ is designed to minimize the possibility of hazards from errors in the software program by following sound engineering design processes, Risk Analysis and Software Validation. ■ Variation in hemoglobin measurements may be profound and may be affected by sample type, body positioning, as well as other physiological conditions. As with most hemoglobin tests, 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. ■ High intensity extreme lights (including pulsating strobe lights) directed on the sensor, may not allow the Pulse CO-Oximeter to obtain readings. ■ The Pronto is NOT intended for use as an apnea monitor. ■ The Pronto is NOT intended for use as a continuous monitor. ■ The Pulse CO-Oximeter should be considered an early warning device. 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 Pulse CO-Oximeter should not be used as a replacement or substitute for ECG based arrhythmia analysis. ■ The Pronto is to be operated by qualified personnel only. This manual, accessory directions for use, all precautionary information, and specifications should be read before use. ■ Electric shock hazard. Do not open the Pronto device. Only a qualified operator may perform maintenance procedures specifically described in this manual. Refer servicing to Masimo for repair of this equipment. ■ 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. ■ Interfering Substances: Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings. ii

Masimo Pronto Pulse CO-Oximeter Operator’s Manual

SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (C0NTINUED)

■ SpO2 is empirically calibrated to functional arterial oxygen saturation in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). A Pulse CO-Oximeter cannot measure elevated levels of COHb or MetHb. Increases in either COHb or MetHb will affect the accuracy of the SpO2 measurement. ■ For increased COHb: COHb levels above normal tend to increase the level of SpO2.

The level of increase is approximately equal to the amount of COHb that is present. NOTE: High levels of COHb may occur with a seemingly normal SpO2. When elevated levels of COHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed. ■ For increased MetHb: the SpO2 may be decreased by levels of MetHb of up

to approximately 10% to 15%. At higher levels of MetHb, the SpO2 may tend to read in the low to mid 80s. When elevated levels of MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be preformed. ■ Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO2 measurements. ■ Elevated levels of Carboxyhemoglobin (COHb) will lead to inaccurate SpO2 measurements. ■ Elevated levels of Total Bilirubin may lead to inaccurate SpO2 and SpHb measurements. ■ Motion artifact may lead to inaccurate SpHb measurements. ■ Severe anemia may cause erroneous SpO2 readings. ■ Hemoglobin synthesis disorders may cause erroneous SpHb 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. ■ 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. ■ Always remove the sensor from the patient and completely disconnect the patient from the Pronto before bathing the patient. ■ 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). ■ Do not place the Pronto where the controls can be changed by the patient. ■ Do not place the Pronto face against a surface. This will cause the alarm to be muffled. ■ Do not place the Pronto on electrical equipment that may affect the Pulse CO-Oximeter, preventing it from working properly.

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SAFETY INFORMATION, WARNINGS, CAUTIONS AND NOTES (CONTINUED)

■ 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. ■ If the Pronto fails any part of the setup procedures or leakage spot check, remove the device from operation until qualified service personnel have corrected the situation. ■ Patient Safety - If a sensor is damaged in any way, discontinue use immediately. ■ Disposal of product - Comply with local laws in the disposal of the device and/or its accessories. ■ The Pronto can be used during defibrillation, but the readings may be inaccurate. ■ A functional tester cannot be utilized to assess the accuracy of the Pulse CO-Oximeter 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. ■ 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. ■ Ensure the speaker is not covered or the device is placed face-down on bedding or other sound absorbing surface. ■ 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.

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Masimo Pronto Pulse CO-Oximeter Operator’s Manual

table of contents

SECTION 1 - OVERVIEW ... 1-1 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... 2-1 Introduction ... 2-1 Front Panel Controls ... 2-1 Rear Panel... 2-3 Symbols... 2-4 SECTION 3 - SETUP ... 3-1 Introduction ... 3-1 Unpacking and Inspection ... 3-1 Preparation for Measurement ... 3-1 Power Requirements ... 3-1 Device Setup ... 3-2 Initial Setup... 3-2 SECTION 4 - OPERATION ... 4-1 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 Replacement ... 4-5 Low Battery Audible Alarm ... 4-6 Alarm Identification... 4-6 Battery Level Indicator... 4-6 Setup Menu ... 4-7 Menu Navigation ... 4-7 Exit the Menu and Power Off the Device ... 4-10 Masimo Pronto Pulse CO-Oximeter Operator’s Manual

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table of contents

SECTION 4 - OPERATION (CONTINUED) Trend Setup and Use... 4-11 Introduction ... 4-11 Trend Utility Installation... 4-11 TrendCom Utility Operation... 4-11 Erasing Trend Memory... 4-12 Trend Data Format... 4-12 Sample Trend Output ... 4-12

SECTION 5 - MESSAGES ... 5-1 Messages ... 5-1 SECTION 6 - TROUBLESHOOTING ... 6-1 Troubleshooting ... 6-1 SECTION 7 - SPECIFICATIONS ... 7-1 Specifications ... 7-1 Performance ... 7-1 Accuracy... 7-1 Electrical ... 7-1 Environmental... 7-2 Physical Characteristics ... 7-2 Compliance ... 7-2 SECTION 8 - SENSOR AND PATIENT CABLES ... 8-1 Introduction ... 8-1 Selecting a Masimo SET Sensor Only ... 8-1 Masimo Rainbow® Sensors ... 8-2 SpHb Rainbow Reusable and Adhesive Sensors ... 8-2 Sensor Accuracy ... 8-3 Cleaning and Reuse of Masimo Reusable Sensors and Cables ... 8-3 SECTION 9 - SERVICE / MAINTENANCE ... 9-1 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 ... 10-1 Accessories ... 10-1

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Masimo Pronto Pulse CO-Oximeter Operator’s Manual

overview

1

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 gives a general description of pulse oximetry.

SECTION 2

SYSTEM DESCRIPTION describes the system, functions and features.

SECTION 3

SETUP describes how to setup the Pronto for use.

SECTION 4

OPERATION describes the operation of the Pronto.

SECTION 5

MESSAGES describes the alarm system messages.

SECTION 6

TROUBLESHOOTING gives troubleshooting information.

SECTION 7

SPECIFICATIONS gives the detailed specifications of the Pronto.

SECTION 8

SENSORS AND PATIENT CABLES outlines how to use and care for the sensors and patient cables.

SECTION 9

SERVICE AND MAINTENANCE describes how to maintain, service and obtain repair for the Pronto.

SECTION 10 ACCESSORIES

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1 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 extra general information is applicable. Sample of Note: NOTE: This is a sample of a Note.

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Masimo Pronto Pulse CO-Oximeter Operator’s Manual

overview

1

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 (BPM) 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 (BPM) The Pronto uses multiple wavelengths of light and proprietary algorithms to obtain functional arterial oxygen saturation (SpO2) and pulse rate (BPM) readings. Accurately and non-invasively measures and displays total hemoglobin (SpHb) The Pronto measures total hemoglobin (SpHb) using similar principles as pulse oximetry with more 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. for signal identification and quality indication ■ Lightweight, ergonomic handheld design ■ Bright, multicolored lights and display ■ Sensor life indicator shows relative 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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1

overview Pulse CO-Oximetry SpO2 GENERAL DESCRIPTION Pulse oximetry is a 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 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 device. The device displays the calculated data as a percent value for functional arterial oxygen saturation (SpO2). The following figure shows the general spot checking setup.

1. Device 2. Sensor

2

1

SpHb GENERAL DESCRIPTION Pulse CO-Oximetry is a noninvasive method of measuring the levels of total hemoglobin (SpHb) in arterial blood. It relies on the same principles as 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 device. The device displays the calculated data as measurement of total hemoglobin concentration.

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overview

PRINCIPLE OF OPERATION Pulse CO-Oximetry is governed by the following principles: 1. Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood) and blood plasma constituents differ in their absorption of visible and infrared light (using spectrophotometry, see figure below). Absorption Spectra 4.0

Oxyhemoglobin Deoxyhemoglobin

3.5

Plasma

Absorption (1/mm)

3.0 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 (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well. The Masimo Pronto Pulse CO-Oximeter 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 a diode (detector). See figure below. Signal data is obtained by passing various visible and infrared lights (500 to 1300nm) through a capillary bed (for example, a fingertip, or thumb) 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 Pronto for calculation. 1

1.

Light Emitting Diodes (LEDs) (7+ wavelengths)

2.

Recessed Detector

2

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. The SpHb measurement relies on a multiwavelength calibration equation to quantify the percentage 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.

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1

overview

FUNCTIONAL SATURATION The Pronto 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. See the Safety information, Warnings, Cautions and Notes section in front of this manual for details. PRONTO VS. DRAWN WHOLE BLOOD MEASUREMENTS When SpO2 and SpHb measurements obtained from the device (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 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, 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 conventional Pulse COOximeters. Conventional Pulse CO-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 CO-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. SpHb MEASUREMENTS DURING PATIENT MOTION 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)

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Masimo Pronto Pulse CO-Oximeter Operator’s Manual

1

overview

MASIMO SET PARALLEL ENGINES

12

FST

MST

SpOC

MASIMO SET DST®

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system description Introduction The Pronto is a spot check Pulse CO-Oximeter which includes non-invasive total hemoglobin (SpHb) measurement. The device is designed for accuracy and ease of operation. All hemoglobin pulse oximetry measurement information, as well as device status data, is displayed on the front panel of the device. All user input is handled by control buttons on the front panel and the sensor cable connection is located at the top edge of the device. The Pronto is powered by 4 “AA” alkaline batteries to provide the capacity of 8 hours of continuous use. Continous use is defined as consecutive spot check tests with each consecutive spot check test initiated immediately upon the conclusion of the previous spot check test. A spot check sensor attaches to the patient cable connector or on the top of the Pronto. Front Panel Controls 7 1 2 8

3

9

4 10

11

5 6 12

Pronto

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2

system description Front Panel Controls continued CONTROL / INDICATOR 1

Parameter/Measurement Numeric Display

Displays parameter/measurement numeric values once a spot check test is complete.

2

Pulse Indicator

Flashes with patient pulse during spot check test period indicating patient pulse has been acquired.

3

Spot Check Progress Indicator

Incrementally illuminates upward after a SpHb spot check has been initiated. This indicates progress towards completion of a SpHb spot check. A fully illuminated spot check progress indicator indicates a competed spot check.

4

Parameter/Measurement Label Display

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

5

Power On / Off

Press the button once to power on the device. Press the button and hold for 2 seconds to power off the device.

6

Battery Level Indicator

Provides a visual representation of the battery charge status. Battery charge level is indicated by four LED indicators. All four indicators will be lit when the batteries are full, with fewer indicators being lit as the batteries lose their charge.

7

Patient Cable /Sensor Connector

The Patient Cable connector connects the Pronto to a SpHb Rainbow reusable sensor or to a patient cable with a hemoglobin sensor.

8

Low SIQ Indicator

SIQ or Signal IQ is a signal identification and quality indicator. When this indicator illuminates, re-checking the measurement is necessary.

Sensor Use Indicator

LEDs extinguish downward indicating apppoximate number of uses remaining of the attached sensor. The bottom LED will illuminate red to indicate remaining uses for the connected sensor are low. The approximate number of sensor uses remaining is displayed upon power up and the connection of a sensor.

SpHb Button

Pressing the "SpHb" button initiates a hemoglobin spot check for total hemoglobin (SpHb), oxygen saturation (SpO2), perfusion index (PI) and pulse rate (BPM). When in the configuration menu, pressing this button will confirm a menu setting and navigate to the next menu option. (See Section 4, Operation.)

11

Up/Down Arrow Buttons

Use the Up and Down arrow buttons to scroll between parameter or measurement spot check results. When in the configuration menu, use the Up and Down arrow buttons to scroll through menu setting options. (See Section 4, Operation.)

12

Speaker

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

9

10

2-2

DESCRIPTION

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.

Pronto CONTROL / INDICATOR 1

Serial Number Label

2

Certification Label

3

Battery Cover

4

Battery Cover Release

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system description

2

SYMBOLS The following symbols are 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 restricts this device to sale by or on the order of a physician (USA audiences only) Year of manufacture Storage humidity range: 5% to 95%

5%-95% RH

+70 C

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

Storage temperature range: +70˚C to -40˚C Storage altitude range: +1600hPa to +500hPa Keep dry Fragile/breakable, handle with care

EC

REP

EU authorized representative

Underwriter's Laboratories Inc. certification

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Masimo Pronto Pulse CO-Oximeter Operator’s Manual

setup

3

Introduction Before the Masimo Pronto Pulse CO-Oximeter can be used, it needs to be inspected, properly setup and the batteries need to be installed. Unpacking and Inspection Remove the device from the shipping carton and examine for signs of shipping damage. Check all materials against the packing list. Save all packing materials, invoice and bill of lading. These may be required to process a claim with the carrier. If anything is missing or damaged, contact the Technical Service Department. The contact address and phone numbers are listed in Section 9, Service and Repair. Preparation for Spot Checking The following sections of the manual describe the preparation, set-up and initial installation of the Masimo Pronto Pulse CO-Oximeter. POWER REQUIREMENTS The Pronto is powered by 4 “AA” alkaline batteries. Do not use any other type of batteries or power source to run the device. The battery compartment is accessed from the back of the device. To install the batteries first remove the battery cover by depressing the small rectangular button at the bottom of the cover, and sliding the cover down off the bottom of the device. Install the batteries in the directions indicated by the battery icons inside the battery compartment. Replace the battery cover by sliding it back up from the bottom of the device until the rectangular locking button snaps back into position. WARNING: USE ONLY ALKALINE BATTERIES. USE OF NON ALKALINE BATTERIES MAY AFFECT THE ACCURACY OF THE BATTERY LEVEL METER. WARNING: USE OF BATTERIES WITH A CELL VOLTAGE OF MORE THAN 1.5V COULD CAUSE DAMAGE TO THE PRONTO. Battery charge level is indicated by four LED indicators at the bottom of the front panel. All four indicators will be lit when the batteries are full, with fewer indicators being lit as the batteries lose their charge. When battery life is approaching depletion, the final battery indicator will begin to flash and an audible alarm will sound.

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