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NIOX MINO - User Manual

NIOX MINO
24 pages
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NIOX MINO
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User Manual
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Summary

Presentation of NIOX MINO

Instrument and Screen Layout

Illustrates the key components and display screens of the NIOX MINO instrument, including main and settings screens.

Installation and Initial Setup

Installing Sensor and Scrubber

Step-by-step guide for installing the sensor, NO scrubber, and connecting the power supply for first-time use.

Measurement Procedures

Entering Patient Identification

Instructions for optionally entering a patient-specific ID before starting a measurement for tracking.

Performing FeNO Measurements

Conducting a FeNO Measurement

Detailed steps for conducting a Fractional Exhaled Nitric Oxide measurement, including inhalation and exhalation guidance.

Stored Results and Ambient NO

Viewing Stored Measurement Results

How to access and review previously recorded measurement results on the instrument display.

Ambient Nitric Oxide Measurement

Procedure for measuring ambient Nitric Oxide levels in the surrounding environment.

Settings and Configuration

Adjusting Time and Date

Guide to adjusting the instrument's time, date, and preferred time format (US/ISO).

Sound and Light Control

How to configure sound volume levels and top light intensity on the device.

Bluetooth On;Off Settings

Steps for enabling or disabling Bluetooth communication for data transfer to a PC.

Quality Control (QC) Activation

Information on activating or deactivating the optional External Quality Control (QC) procedure.

Information Menu and Power Off

Accessing Instrument Information

How to view instrument details, sensor status, software version, and alert codes via the information menu.

Safely Powering Down the Unit

Instructions for safely powering down and preparing the NIOX MINO instrument for relocation.

General Care and Component Replacement

Performing Preventive Inspections

Recommended visual checks before each measurement to ensure instrument integrity and proper attachment of components.

Replacing the NIOX MINO Sensor

Step-by-step guide on how to safely remove and install a new NIOX MINO Sensor.

Replacing the NO Scrubber

Instructions for replacing the NO scrubber component, ensuring correct installation.

Troubleshooting and Support

Troubleshooting Warning and Action Codes

Provides actions for specific warning symbols or alert codes displayed on the instrument during operation.

Disposal of Used Consumables

Guidelines for the proper disposal of used NIOX MINO Sensors and NO scrubbers according to regulations.

Contacting Technical Support

Information on how to contact Circassia support for assistance with operational issues or error codes.

Understanding the Limited Warranty

Details on the warranty coverage provided for the NIOX MINO instrument and its original accessories.

Technical Specifications

Display Buttons and Symbols Overview

Describes the various buttons and icons displayed on the NIOX MINO screen for navigation and status indication.

Explanation of Symbols

Provides detailed meanings for symbols used within the manual and on the instrument interface.

Base Label Identification

Details information found on the product's base label, including serial numbers, article numbers, and expiration dates.

Instrument Dimensions and Weight

Lists the physical dimensions (height, width, depth) and total weight of the NIOX MINO instrument.

Electrical Safety and Data

Outlines electrical safety compliance (IEC standards) and power specifications for the device.

NIOX MINO Instrument Details

Specifies technical parameters for the NIOX MINO instrument, including secondary voltage and power consumption.

Power Supply Unit Specifications

Information regarding the external power adapter, mains voltage range, and power consumption.

Standby Noise Level

Specifies the noise level emitted by the instrument when it is in standby mode, measured at a distance.

Instrument and Sensor Shelf-Life

Details the expected shelf-life of the NIOX MINO instrument and its disposable sensor.

Optimal Operating Conditions

Specifies the recommended environmental conditions (temperature, humidity, pressure) for optimal instrument performance.

Performance and Usage Data

Exhaled NO Measurement Performance

Details performance metrics for exhaled Nitric Oxide measurements, including measurement range, detection limit, and time.

Exhalation Parameter Requirements

Specifies the required exhalation parameters, such as time and pressure, for accurate measurements.

Transport and Storage Guidelines

Guidelines for safely transporting and storing the NIOX MINO instrument and sensor to maintain their integrity.

Patient Filter Functionality

Information on the disposable patient filter (NIOX Filter) used for each measurement, including its type.

Parts and Accessories List

Included NIOX MINO Package Contents

Lists all components and items that are part of the standard NIOX MINO package.

Items Delivered Separately

Identifies essential components and the user manual available for purchase separately from the main unit.

Available NIOX MINO Accessories

Details various optional accessories offered for use with the NIOX MINO system, such as test kits and bags.

PC Connectivity Options

Connecting NIOX MINO via USB

Instructions for establishing a wired connection between the NIOX MINO instrument and a PC using a USB cable.

Connecting NIOX MINO via Bluetooth

Steps to establish a wireless connection between the NIOX MINO instrument and a PC using Bluetooth technology.

NIOX Panel PC Software

Information about the NIOX Panel software for PC-based monitoring and data management.

Applications and Safety Precautions

Research Application Notes

Clarifies that certain measurement modes are intended for research use only and are not clinically validated.

General Cautions and Warnings

Lists important safety precautions, device handling warnings, and potential interference issues.

Clinical Context and Vigilance

Clinical Documentation and References

References to scientific standards and studies supporting the NIOX MINO's measurement methodology and accuracy.

Adverse Incident Reporting (Vigilance)

Explains Circassia's system for reporting adverse incidents related to medical devices to health authorities.

Guidance and Declarations

Electromagnetic Emissions Compliance

Details the device's compliance with electromagnetic compatibility (EMC) standards and potential external interference.

NIOX MINO Specifications

General IconGeneral
Measurement PrincipleElectrochemical sensor
Weight230 g (8.1 oz)
Dimensions145 mm x 75 mm x 30 mm (5.7 in x 3.0 in x 1.2 in)
Device TypeFeNO Monitor
Target UseMeasurement of fractional exhaled nitric oxide (FeNO) in breath
Power SourceRechargeable battery
DisplayLCD
ConnectivityUSB
Operating Temperature10°C to 40°C
Storage Temperature-20°C to 60°C
Humidity Range10 to 95% RH
CalibrationAutomatic calibration

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