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NDD easyone pro User Manual

NDD easyone pro
188 pages
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Version V04b
EasyOne Pro™
EasyOne Pro™ LAB
Operator's Manual

Table of Contents

Questions and Answers:

NDD easyone pro Specifications

General IconGeneral
Device TypeSpirometer
CategoryMedical Equipment
ConnectivityUSB, Bluetooth
Measurement MethodUltrasonic
Battery Life8 hours
DisplayHigh-resolution color display
Flow sensorUltrasonic
Parameters MeasuredFVC, FEV1, PEF
StandardsATS/ERS 2005
Data StorageInternal memory with up to 10, 000 tests
SoftwareNDD EasyOne Connect

Summary

1 Introduction

1.1 CE Marking Information

Product compliance with CE marking and Council Directive 93/42/EEC.

1.6 Safety Information

General safety guidelines and the manual's importance for device operation.

Definitions

Classification of safety information: Danger, Warning, and Caution.

Safety Notices

Specific safety warnings regarding explosion hazards.

1.7 Intended Use

System design and application for lung function measurements.

1.8 Contraindications to Performing DLCO Tests

Conditions where DLCO tests should not be performed.

1.10 Components and Functional Description of EasyOne Pro™

Block diagram and list of device components and their functions.

1.11 EasyOne Pro™ Flow Sensor Design and Operation

Principle of ultrasound flow sensor measurement and calibration.

1.12 Test Gas Requirements

Specifications for DLCO test gas mixtures.

2 Start-up and Initial Preparation

2.1 Unpacking, Environmental Conditions

Procedures for checking shipment, cleaning, and ambient conditions.

2.2 Equipment Description

Illustration of the EasyOne Pro™ device with labeled parts.

2.4 Gas Supply

Instructions for DLCO and FRC gas supply connection.

2.7 Power

Caution regarding power line connection and grounding.

2.9 Switching the Device On, Functional Test

Steps to turn on the device and perform a functional test.

3 Performing a Test

3.1 Selecting/Adding a Patient

Steps to select an existing patient or add a new one.

3.2 Selecting a Test

Overview of available test types: FVC, SVC, MVV, DLCO, FRC.

3.3 Forced Vital Capacity (FVC/FVL)

Initiating the FVC/FVL test and overview of the acquisition screen.

3.4 Vital Capacity (SVC)

Performing slow vital capacity measurements starting from tidal breathing.

3.5 Maximum Voluntary Ventilation (MVV)

Measuring maximum ventilation volume over 12 seconds.

3.6 Bronchial Provocation

Introduction to provocation tests and safety information.

3.8 CO Diffusing Capacity (DLCO)

Preparation and steps for performing a DLCO test.

3.9 FRC Test (EasyOne Pro™ LAB only)

Introduction to FRC measurement using nitrogen washout.

3.10 Ending the Test

Procedures for ending a test and disposing of consumables.

3.11 Retrieving/Printing Stored Tests

Saving and recalling old measurements.

3.12 Trend View

Observing measured parameter values over time.

3.13 Definition of Important Parameters

Definitions of key spirometry parameters like FVC, FEV1, etc.

4 Editing Patient Data

4 Editing Patient Data

How to select, edit, and update patient data.

5 Quality Messages and Quality Grades

5.1 FVC/FVL Quality Messages and Quality Grades

Basic facts and remarks on end-of-test criteria and quality grading.

5.2 SVC Quality Messages and Quality Grades

SVC quality messages, criteria, and recommended actions.

5.3 DLCO Quality Messages and Quality Grades

DLCO quality messages, criteria, and recommended actions.

5.5 System Interpretation

Assessing system interpretation based on quality grade and details.

5.6 Retrospective Test Assessment, Entering Comments

Changing trial acceptability and ranking of tests, entering comments.

6 Switching the Device Off

6 Switching the Device Off

Procedures for safely shutting down the device and quitting the program.

7 Hygiene, Cleaning, Maintenance, Disposal

Hygiene, Cleaning, Maintenance, Disposal

Precautions for hand hygiene, cleaning, maintenance, and disposal.

Software Update

Procedure for updating the device's software and firmware.

Check Measuring Accuracy

Checking measuring accuracy through calibration.

DLCO Calibration Check

Checking DLCO calibration with a simulator or test subject.

Calibration Check with Test Subject

Performing calibration using a Biological Standard subject.

8 System Settings

System Settings Menu

Accessing system settings via Utilities: Configuration, Calibration, Advanced.

Configuration

Overview of configuration tabs: General, Test, Device, Report, Printer, EMR, Environment.

Test Tab

Sub-menus for test configuration: General, FVC/FVL, SVC, MVV, DLCO, FRC, Cal Check, Provocation.

DLCO Tab

Setting up the device for DLCO tests, including gas concentrations.

9 Troubleshooting Tips

Troubleshooting Tips

Table of common problems, error messages, and their solutions.

10 Specifications

Specifications

Technical specifications for dimensions, weight, flow, and analyzers.

11 Order Information

Order Information

List of available accessories and spare parts with part numbers.

12 Appendix

12.1 Interpretation

Overview of automatic system interpretation and GOLD-Hardie criteria.

12.4 Introduction to Adjustment of DLCO Measurements

Adjustments for DLCO measurements based on hemoglobin and PAO2.

12.5 How to interpret TLC from a single breath maneuver

Interpreting Total Lung Capacity from single breath maneuvers.

12.6 Report Designer

Starting the Report Designer and accessing the Layout Editor.

12.7 Electromagnetic Compatibility (EMC)

Guidance and declaration regarding electromagnetic emissions.

12.8 Microsoft Software License Terms for Windows® XP Embedded Runtime

License terms for the embedded operating system software.

12.9 Quick Reference Guide to the Screen Displays

Overview of the initial screen display elements and navigation.

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