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Masimo Pronto Pulse CO-Oximeter User Manual

Masimo Pronto Pulse CO-Oximeter
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Operator's Manual
Pronto
®
Pulse CO-Oximeter
®

Table of Contents

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Masimo Pronto Pulse CO-Oximeter Specifications

General IconGeneral
Perfusion Index Range0.02-20%
DisplayColor LCD
TypeHandheld Pulse CO-Oximeter
Measurement ParametersSpHb, SpO2, pulse rate, SpCO, SpMet, PVi, perfusion index
SpO2 Accuracy±2% (70-100%)
SpCO Range0-40%
PVi Range0-100
ConnectivityUSB
Relative Humidity10% to 95% (non-condensing)
SpCO Accuracy±3% (0-40%)
SpMet Range0-15%
SpMet Accuracy±1.5% (0-15%)

Summary

About This Manual

Product Description, Features, and Indications for Use

Product Description and Features

Details the Pronto's capabilities including SpO2, PR, PI, SpHb monitoring, and Masimo SET technology.

Indications for Use

Outlines the intended use for noninvasive spot-checking of functional oxygen saturation and total hemoglobin.

Contraindications

Specifies conditions where the Pronto device should not be used, such as an apnea or continuous monitor.

Safety Information, Warnings, and Cautions

Safety Warnings and Cautions

Covers essential safety warnings related to device operation, damage, MRI use, and handling.

Performance Warnings and Cautions

Addresses critical warnings regarding medical decisions, measurement accuracy, and specific usage scenarios.

Cleaning and Service Warnings and Cautions

Provides warnings for safe cleaning procedures, battery handling, and service requirements.

Compliance Warnings and Cautions

Details warnings related to FCC compliance, modifications, and disposal of the device.

Chapter 1: Technology Overview

Masimo Signal Extraction Technology (Masimo SET®)

Explains Masimo's proprietary signal processing technology for accurate pulse oximetry.

Masimo SET® Parallel Engines

Illustrates the conceptual parallel processing engines used in Masimo SET technology for signal extraction.

Pulse Oximetry Parameters Description

Describes SpO2, PR, and PI measurements, their principles, and how they are determined.

rainbow Pulse CO-Oximetry Technology

Details the technology distinguishing various hemoglobin types by their light absorption spectra.

SpO2 and SpHb Measurements During Patient Motion

Discusses the accuracy of SpO2 and SpHb during motion and the role of the Low SIQ indicator.

Chapter 2: System Description

Front Panel

Identifies and describes the components, controls, and indicators on the front panel of the Pronto device.

Rear Panel

Details the labels and features found on the rear panel, including serial numbers and certifications.

Chapter 3: Setup

Unpacking and Inspection

Guides users on proper unpacking, inspection for shipping damage, and checking package contents.

Power Requirements

Specifies the power source for the Pronto device and important considerations for battery usage.

Initial Setup

Provides step-by-step instructions for the initial setup, including battery installation and power-on.

Chapter 4: Operation

Basic Operation

Step-by-step guide for turning on the device, connecting sensors, and performing a spot check.

Spot Check Results

Explains how to view spot check results and the parameters displayed after a measurement.

Default Settings

Lists the factory default and configurable settings for various device options and parameters.

Audible Alerts

Describes the audible alerts for low battery and system failure conditions and their meaning.

Battery Level Indicator

Explains how the four LED indicators communicate the remaining battery capacity of the device.

Navigating the Menu

Details the process of accessing and navigating the device's menu system for settings adjustment.

Trend Setup and Use

Covers storing, transferring, and managing trend data collected from spot check measurements.

Chapter 5: Messages

Messages

Lists various messages displayed by the Pronto, their explanations, and recommended next steps.

Chapter 6: Troubleshooting

Troubleshooting

Provides a chart of common symptoms, their possible causes, and recommended solutions for device issues.

Low Perfusion

Discusses the impact of low perfusion levels on measurement accuracy and interpretation.

Low Signal I.Q. (Low SIQ)

Explains the meaning of the Low SIQ indicator and actions to take when it appears.

Low Battery Audible Alert

Describes the audible alert for low battery conditions and the importance of prompt battery replacement.

Chapter 7: Specifications

Performance Specifications

Details the accuracy specifications for SpO2, PR, and SpHb under various measurement conditions.

Display Ranges

Lists the operational display ranges for SpO2, SpHb, PR, and PI measurements.

Resolution

Specifies the measurement resolution for SpO2, SpHb, and Pulse Rate.

Electrical

Outlines the electrical specifications, including battery type, capacity, and isolation details.

Environmental

Covers the operating and storage temperature, humidity, and altitude specifications.

Physical Characteristics

Provides the physical dimensions and weight of the Pronto Pulse CO-Oximeter.

Trend Memory

Details the capacity and function of the device's trend memory for storing spot check data.

Alerts

Lists the types of audible alerts and their corresponding characteristics.

Display Indicators

Describes the data displayed and the various indicators (LEDs) on the Pronto device.

Compliance

Lists the safety and regulatory compliance standards that the device adheres to.

Guidance and Manufacturer's Declaration - Electromagnetic Emissions

Declares the device's compliance with electromagnetic emission standards and provides guidance.

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

Provides declarations regarding electromagnetic immunity compliance and necessary environmental conditions.

Recommended Separation Distances

Specifies recommended separation distances for portable and mobile RF communications equipment.

Chapter 8: Service and Maintenance

Cleaning

Provides detailed instructions for cleaning the Pronto device using approved cleaning solutions.

Battery Replacement

Guides the user through the process of replacing the AA alkaline batteries in the Pronto.

Performance Verification

Outlines procedures for testing the device's performance after repairs or during routine checks.

Service and Repair

Explains the policy for warranty repair and the necessary steps for returning malfunctioning equipment.

Return Procedure

Details the required steps and documentation for returning the Pronto for service or repair.

Limited Warranty

Exclusions

Lists specific conditions and circumstances under which the product warranty is not applicable.

Limitation of Warranty

States the warranty limitations, disclaimers, and Masimo's liability regarding the product.

Sales & End-User License Agreement

Restrictions

Outlines copyright, use, and transfer restrictions for the product's software and related materials.

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