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International Biomedical AeroNOx 2.0 User Manual

International Biomedical AeroNOx 2.0
100 pages
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Portable Nitric Oxide
Titration & Monitoring System
Operator’s Manual
Aero
2.0
NOx
INT-ENG

Table of Contents

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International Biomedical AeroNOx 2.0 Specifications

General IconGeneral
NO2 Range0-20 ppm
Response Time<30 seconds
Operating Humidity15-95% RH, non-condensing
Power100-240 VAC, 50-60 Hz
Power Supply100-240V AC, 50/60Hz
Battery Life8 hours
Dimensions5 cm
Data StorageInternal memory
ConnectivityUSB
DisplayLCD

Summary

General Information

Introduction

Overview of the AeroNOx 2.0 system, its components, and purpose.

Intended Use

Details the specific applications and intended patient population for the device.

Medical Indication

Specifies medical conditions for which nitric oxide therapy is indicated.

Contraindication

Lists conditions under which inhaled nitric oxide therapy is not advised.

Safety Summary

General safety guidelines for operating the AeroNOx 2.0 system.

Classification

Details the device's classification according to safety standards.

Important Safety Considerations

Highlights critical warnings, cautions, and notes for safe operation.

Symbols

Explains various symbols used in the AeroNOx 2.0 documentation and on the device.

Abbreviations

Lists and defines common abbreviations used in the manual.

Unpacking

Lists the components included in the AeroNOx 2.0 system package.

Initial Setup

Step-by-step guide for setting up the AeroNOx 2.0 unit.

Purge Procedure

Instructions for purging the system to ensure gas purity and prevent contamination.

Front Panel

Identifies and describes the controls and indicators on the front of the device.

Rear Panel

Identifies and describes the ports and features on the rear of the device.

Navigating Display Screens

Explains how to navigate between the main and calibration display screens.

Main Display Screen

Details the information shown on the main operational display screen.

Calibration Mode Display Screen

Describes the options available in the calibration mode screen.

Universal Power Supply

Explains the function and use of the universal power supply and charging.

Theory of Operation

Explains how the AeroNOx 2.0 system delivers and monitors nitric oxide.

Environmental Effects

Discusses how environmental factors can affect the device's performance.

NO and NO2

Explains sensor response to pressure changes for NO and NO2.

Oxygen

Explains how pressure affects oxygen sensor readings.

Flow Meter Display

How the flow meter display works and its limitations.

Other Environmental Conditions

How various environmental factors affect operation.

Degraded Performance

Factors leading to degraded performance over time.

Pre-Use Checkout/Alarm Verification

Patient Operations

Before Operation

Instructions to complete before connecting the device to a patient.

Connection to Ventilator Circuit (General)

General guidelines for connecting the AeroNOx 2.0 to a ventilator circuit.

INOstat Bagger backup NO Delivery System

Description of the INOstat Bagger as a backup NO delivery system.

INOstat Kit Pre-Use Checkout

Steps for performing a pre-use check of the INOstat Kit.

INOstat Kit Instructions for Use

Detailed steps for using the INOstat Kit for NO delivery.

Connection to Various Breathing Systems

Describes methods for connecting to different breathing systems.

Conventional Sample/Delivery Kit, AeroNOx 2.0™

How to use the conventional sample/delivery kit with the device.

Connection DIAGRAM - ICU Ventilator Circuit

Diagram showing how to connect the device to an ICU ventilator circuit.

Steps to Connect to an ICU Ventilator Circuit

Step-by-step instructions for connecting to an ICU ventilator.

Connection DIAGRAM - Transport Ventilator Circuit

Diagram showing how to connect the device to a transport ventilator circuit.

Steps to Connect to a Transport Ventilator Circuit

Step-by-step instructions for connecting to a transport ventilator.

Connection Diagram - High Frequency TXP-2D Phasitron

Diagram for connecting the device to a High Frequency TXP-2D Phasitron.

Steps to Connect to a High Frequency TXP-2D Phasitron

Step-by-step instructions for connecting to the Phasitron.

Connection Diagram - AeroNOx 2.0™ Bagger

Diagram for connecting the device to the AeroNOx 2.0 Bagger.

Steps to Connect to AeroNOx 2.0™ Bagger

Step-by-step instructions for connecting to the AeroNOx 2.0 Bagger.

Alarms

General Alarm Information

An overview of the alarm system and its messages.

Priority Alarms

Information on alarm priorities, tones, and visual cues.

Alarm Silencing

How to silence active alarms and the associated icon.

User Adjustable Monitor Alarms

How to adjust alarm limits for monitored parameters.

Safety Shut Off

Details the safety shut-off system and how to override it.

Alarm Table

Lists system alarms with graphic representations and associated causes.

Calculations & Troubleshooting

Calculations for Nitric Oxide Delivery

Formulas and examples for calculating NO flow rates.

What is the diluted FiO2?

Formula to estimate the diluted FiO2 after adding NO.

How are we doing?

Explains the Oxygen Index calculation and interpretation.

Calculation of Cylinder Duration

How to calculate the remaining duration of a gas cylinder.

Gas Supply

Information on gas supply, specifically for NO cylinders.

Troubleshooting Guide

Provides guidance for resolving common issues with the device.

Calibration

Low Range (ZERO) Calibration (Daily)

Procedure for daily low range (zero) calibration using room air.

O2 High Range Calibration (WEEKLY)

Procedure for weekly high range calibration of the O2 sensor.

NO High Range Calibration (WEEKLY)

Procedure for weekly high range calibration of the NO sensor.

NO2 High Range Calibration (WEEKLY)

Procedure for weekly high range calibration of the NO2 sensor.

Maintenance

User Maintenance Schedule

Schedule for routine user maintenance tasks.

Cleaning the AeroNOx 2.0™

Instructions and approved agents for cleaning the device.

Preventive Maintenance

Schedule and details for preventive maintenance tasks.

Return Merchandise Authorization

Process for returning the device for repair or service.

Replacing NO, NO2, and O2 Sensors

Step-by-step guide for replacing the gas sensors.

Battery Replacement

Instructions for replacing the internal rechargeable battery.

Replacing the Tip on the AeroNOx 2.0™™ Delivery Regulators

Procedure for replacing worn tips on delivery or backup regulators.

Parts and Accessories

Lists available parts and accessories with their part numbers.

Mounting Options

Describes methods for mounting the AeroNOx 2.0™™.

Dovetail

Details the dovetail mounting system and its limitations.

VESA 75mm

Details the VESA 75mm mounting standard for installation.

Disposal

Guidelines for the proper disposal of accessories, sensors, and the device.

Warranty

Product Specifications

Ventilator Compatibility

Lists ventilators validated for use with the AeroNOx 2.0™™.

Measurement Range and Accuracy

Details the measurement ranges and accuracy of the device's sensors.

Backup Delivery Regulator

Specifications for the backup delivery regulator.

INOstat Bagger

Specifications for the INOstat Bagger.

AeroNOx 2.0™™ Delivery Regulator

Specifications for the AeroNOx 2.0™™ delivery regulator.

AeroNOx 2.0™™ Physical Specifications

Physical dimensions and weight of the device.

AeroNOx 2.0™™ Environmental Specifications

Operating and storage environmental parameters.

AeroNOx 2.0™™ Electrical Specifications

Electrical characteristics and standards compliance.

Sensor Specifications

Performance specifications for the NO, NO2, and O2 sensors.

EMC Compliance

Information on electromagnetic compatibility and interference.

Essential Performance

Critical performance aspects of the device for safety and operation.

Appendix

NO2 Sensor Datasheet

Technical data sheet for the NO2 sensor.

NO Sensor Datasheet

Technical data sheet for the NO sensor.

Oxygen Sensor Datasheet

Technical data sheet for the Oxygen sensor.

Competency Based Performance Check-off Tool

Tools for assessing user competency in operating the device.