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Masimo Rad-5 User Manual

Masimo Rad-5
70 pages
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Operator's Manual
Rad-5
®
/5v
®
Pulse Oximeter

Questions and Answers:

Masimo Rad-5 Specifications

General IconGeneral
TypeHandheld Pulse Oximeter
SpO2 Range0% to 100%
Pulse Rate Range25 to 240 BPM
Perfusion Index Range0.02% to 20%
Power Source4 AA Alkaline Batteries
Operating Temperature5°C to 40°C
Humidity5% to 95% non-condensing
Storage Temperature-40°C to 70°C (-40°F to 158°F)

Summary

About This Manual

Product Description, Features and Indications for Use

Product Description

Details the noninvasive, arterial oxygen saturation and pulse rate monitors of the Rad-5 family.

Features

Lists common and Rad-5 specific features of the Rad-5/5v pulse oximeter.

Indications for Use

Specifies the intended use of the Rad-5 and Rad-5v pulse oximeters for patient monitoring.

Contraindications

States any conditions under which the device should not be used.

Chapter 1: Technology Overview

Signal Extraction Technology® (SET®)

Explains the Masimo Signal Extraction Technology's processing differences from conventional pulse oximeters.

Masimo SET® Parallel Engines

Illustrates the parallel engines used in Masimo SET® signal processing for conceptual understanding.

General Description for Oxygen Saturation (SpO2)

Explains the principles of pulse oximetry and spectrophotometry for SpO2 measurement.

Successful Monitoring for SpO2 and PR

Provides general points for ensuring successful oximetry monitoring, including sensor placement and site selection.

Functional Oxygen Saturation (SpO2)

Defines functional oxygen saturation (SpO2) as the percentage of hemoglobin available for oxygen transport.

General Description for Pulse Rate (PR)

Explains pulse rate measurement based on the optical detection of peripheral flow pulse.

Signal IQ

Describes the Signal IQ as an indicator of confidence in the displayed SpO2 value and pulse timing.

Chapter 2: Description

General System Description

Provides a general overview of the Rad-5/5v device, including compatible sensors and cables.

Patient Cable Connector and FastSat Indicator

Details the patient cable connector and the FastSat indicator on the front panel of the Rad-5/5v.

Front Panel Displays and Controls (Part 1)

Describes saturation, Signal IQ, pulse rate displays, and operational buttons like Mode/Enter, Next, Power, and Battery indicators.

Front Panel Displays and Controls (Part 2)

Details speaker, pulse tone volume, and display brightness controls on the front panel of the Rad-5/5v.

Back View

Details the serial number label, agency approvals label, battery cover, and battery cover release on the back of the Rad-5/5v.

Chapter 3: Basic Setup and Use

Unpacking and Inspection

Instructions for safely unpacking and inspecting the Rad-5/5v device for any signs of damage.

Initial Setup

Steps for preparing and setting up the Rad-5/5v, including battery installation and power verification.

Connecting Sensor and Initial Check

Instructions for connecting the sensor, checking cable security, and selecting a compatible sensor for the Rad-5/5v.

Device Operation and Verification

Details device power-on, display checks, alarm functionality tests, sensor disconnection checks, and alarm silence operation.

Chapter 4: Operation

Basic Operation

Covers basic operation of the Rad-5 and Rad-5v, including powering the device on/off and understanding indicators.

Power Rad-5/5v On and Off

Instructions for turning the Rad-5/5v pulse oximeter on and off.

LED Indicators

Explains the function and location of LED indicators on the Rad-5/5v device.

Signal SIQ and Pulse Bar

Describes the 10-bar LED indicator for signal quality and pulse timing on the Rad-5/5v.

Perfusion Index

Details the 10-bar LED indicator for perfusion index, noting red segments for low perfusion.

Battery Level Indicator

Provides information on the four LED indicators that display remaining battery capacity and when batteries need replacement.

Normal Patient Monitoring

Describes the display during normal operation, showing SpO2 and Pulse Rate on the Rad-5/5v.

Rad-5 Front Panel Control Operation

Explains the function of buttons on the Rad-5 front panel for power, menu navigation, and alarm silence.

Rad-5v Front panel Control Operation

Explains the function of buttons on the Rad-5v front panel for power, display brightness, alarm silence, and pulse tone volume.

Advanced Operation

Information for advanced users on default settings and configuration options for the Rad-5/5v.

Default Settings

Outlines default values that the Rad-5/5v reverts to after a power cycle and user-configurable defaults.

Rad-5 Device Settings

Provides an overview of available Rad-5 menu selections for user configuration, excluding Rad-5v.

Sensitivity (Rad-5)

Details the three sensitivity modes (Normal, APO, Maximum) for the Rad-5, adapting to patient conditions.

Alarm Limits

Specifies the configurable ranges for SpO2 and Pulse Rate alarm limits on the Rad-5, including disabling options.

Trend Settings

Explains how to configure trend settings for storing and transferring SpO2, PR, and PI data from the Rad-5.

TrendCom Utility

Provides instructions for installing and operating the TrendCom utility for data transfer from the Rad-5.

Erasing Trend Memory

Details how to erase trend memory by turning the trend feature off and on.

Trend Data Format

Defines the format of downloaded trend data in an ASCII delimited .out file, including parameters and exception messages.

Menu Navigation

Explains how to navigate the menu system of the Rad-5 using Mode/Enter, Next, and arrow keys.

Menu Level 1 - Alarm Limit and Alarm Volume

Describes how to access and adjust alarm volume and SpO2/Pulse Rate alarm limits in the Rad-5 menu.

Menu Level 2 - Averaging, Sensitivity, FastSat, and SmartTone

Details how to configure averaging time, sensitivity, FastSat, and SmartTone settings in the Rad-5 menu.

Menu Level 3 - Trend Settings

Explains how to enable/disable trending, and set current date and time for data logging on the Rad-5.

Menu Level 4 - LED Brightness and Factory Defaults

Describes how to adjust LED brightness and restore factory defaults in the Rad-5 menu.

Special Menu

Provides an overview of special menu selections available for user configuration on the Rad-5.

Sleep Mode Operation

Details the Rad-5 Sleep Mode, which captures data without triggering alarms and blanks the display.

Standard and Sleep Mode

Instructions on how to enter and exit the special menu, including Standard and Sleep Modes.

Chapter 5: Alarms and Messages

Alarm Indication

Describes how audible alarm tones and visual indicators signal alarm conditions on the Rad-5/5v.

Low Battery Audible Alarm

Explains the audible alarm and flashing indicator for low battery conditions on the Rad-5/5v.

Alarm Silence

Details the three audible alarm suspension settings and how to cycle through them using the Alarm Suspend Button.

Alarm Silenced Indicator

Explains the visual feedback provided by the Alarm Silenced Indicator when audible alarms are muted.

Messages

Lists and explains error messages displayed on the Rad-5, including saturation/pulse rate limit alarms, sensor errors, and system faults.

Messages

Lists and explains error messages displayed on the Rad-5v, including cable and sensor connection issues.

Messages

Lists and explains error messages related to adhesive sensors on the Rad-5/5v, including sensor life and compatibility.

Chapter 6: Troubleshooting

Troubleshooting Chart

Provides a chart to identify and resolve common problems with the Rad-5/5v, such as power issues and speaker tone problems.

Chapter 7: Specifications

Display Range

Specifies the display ranges for SpO2, Pulse Rate (PR), and Perfusion Index (PI) measurements.

Accuracy (ARMS*)

Details the accuracy specifications (ARMS) for SpO2 and Pulse Rate under various conditions like no motion, motion, and low perfusion.

Resolution

Lists the resolution for SpO2 (1%) and Pulse Rate (1 bpm) measurements.

Electrical

Provides electrical specifications, including battery type (4 'AA' Alkaline) and capacity (>30 hours).

Environmental

Outlines environmental conditions for operation and storage, including temperature, humidity, and atmospheric pressure.

Physical Characteristics

Provides physical dimensions and weight of the Rad-5/5v device.

Modes

Details the available Averaging Modes and Sensitivity settings for Rad-5 and Rad-5v.

Alarms

Describes the details of high and low priority alarms, including tone, pulse spacing, and volume levels.

Display/Indicators

Describes the data display and LED indicators on the Rad-5/5v, including those specific to Rad-5.

Compliance

Lists EMC and Safety Standards Compliance for the Rad-5/5v, including IEC and ANSI standards.

Equipment Classification per IEC 60601-1

Details equipment classification, protection types, and mode of operation according to IEC 60601-1 standards.

Guidance and Manufacturer's Declaration - Electromagnetic Emissions

Provides guidance on electromagnetic emissions compliance for the ME Equipment in various environments.

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

Provides guidance on electromagnetic immunity for the ME Equipment concerning ESD, transients, surges, and voltage variations.

Recommended Separation Distances

Recommends separation distances between portable/mobile RF communication equipment and the ME Equipment.

Symbols

Defines symbols found on the Rad-5/5v or its packaging, such as Follow Instructions for Use and CE Mark.

Citations

Lists citations and references for validation studies and technical specifications of the Masimo SET technology.

Chapter 8: Service and Maintenance

Cleaning

Provides instructions for cleaning the Rad-5/5v device using recommended solvents and cleaning agents.

Battery Installation and Replacement

Details the procedure for installing and replacing batteries in the Rad-5/5v, including warnings about battery types.

Performance Verification

Outlines procedures to test the performance of the Rad-5/5v after repairs or during routine maintenance.

Power-On Self-Test

Describes the automatic self-test performed by the Rad-5/5v upon powering on.

Key Press Button Test

Explains how to test the functionality of each button on the Rad-5/5v by verifying acknowledgments.

Alarm Limit Test (Rad-5)

Details how to test the SpO2 and Pulse Rate alarm limits and their functionality on the Rad-5.

LED Brightness

Instructions for adjusting LED brightness levels on the Rad-5.

Testing Rad-5/5v with Masimo SET Tester

Provides steps to test Rad-5 and Rad-5v functionality using a Masimo SET Tester.

Repair Policy

Outlines Masimo's policy for warranty repair and service, emphasizing the need for authorized personnel.

Return Procedure

Details the procedure for returning the Rad-5/5v for service, including cleaning and required documentation.

Restrictions

Lists copyright and use restrictions related to the Rad-5/5v software and accompanying materials.

Contacting Masimo

Provides contact information for Masimo Corporation, including address, telephone, and fax numbers.

Limited Warranty

Details the warranty terms for the Rad-5®/5v® Pulse Oximeter, covering defects and duration.

Exclusions

Lists conditions and circumstances under which the warranty does not apply to the Product or Software.

Limitation of Warranty

Describes the limitations of Masimo's warranty, excluding implied warranties and limiting liability.

Sales & End-User License Agreement

Presents the legal agreement between the purchaser and Masimo Corporation for the Product and Software.

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