RhinoMetrics AS Manual

Information in this document is subject to change without notice and does not represent a commitment on the part of Interacoustics A/S. The software described in this document is furnished under a license terms of the agreement. The software may be usd or copied only in accordance with the allowed in the license or nondisclosure agreement. No part of this manual may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying and recording, for any purpose without the express written permission of Interacoustics A/S. Version 2.1 Edition 1.0 © 2002 by RhinoMetrics A/S Corrections added June 2002 Version 2.1 Edition 1.1 © 2002 by RhinoMetrics A/S Corrections added July 2002 Version 2.1 Edition 1.2 © 2002 by RhinoMetrics A/S Corrections added March 2003 Version 2.1 Edition 1.3 © 2003 by Interacoustics A/S, Assens 80720202 - Version 04/06 © 2006 by Interacoustics A/S

Printed in Denmark

Interacoustics A/S Drejervænget 8 DK-5610 Assens Denmark Phone: Fax:

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+45 6371 3555 +45 6371 3522

RhinoStream

Preface

Preface INTRODUCTION

Congratulations with your new RhinoStream module. We hope that it will be a valuable aid to your research or clinical work and that you will have the opportunity to work with other RhinoMetrics products in the future.

ABOUT RHINOMANOMETRY

The purpose of RhinoStream is to measure the trans-nasal pressure and flow during respiration thus giving a dynamic assessment of the condition of the patient’s nose. By calculating the flow resistance at a specific pressure and displaying the airflow, RhinoStream gives you a better understanding of the patient’s subjective feeling of nasal patency. Rhinomanometry is frequently use alone, or as a supplement to acoustic rhinometry.

PURPOSE OF THIS MANUAL

This user manual will help you to get acquainted with the hardware and show you how to prepare a measurement, how to perform it and save the results in the program’s database. In addition, you will find information about RhinoStream’s analysing and database facilities. If you have any questions or comments on how to operate the device, please feel free to contact your local distributor, who will be able to provide the relevant service and support.

HARDWARE VERSIONS

This manual applies to the following RhinoMetrics hardware versions: • SRE2000 • SRE2000-II (UL-approved) • SRE2100 • SRE2100-II (UL-approved)

PREREQUISITE KNOWLEDGE

The RhinoStream software module is a Windows-based program. Users of this software are expected to have a basic knowledge of Windows-based programs, for example, how to select elements and close windows.

NOMENCLATURE

The following nomenclature is used:

Item

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Convention

Example

Names from the screen, for example windows, menus, push buttons

Arial bold font

The Initialize button

Key indications

Angle brackets and bold font

The <F2> key The <crtl> key

Menus

Arrows are used for indicating the menu structure in instructions how to select a sub menu.

Select Tools →Options

Words to enter exactly as they appear

Courier font

Enter a:setup in the Run window.

Contents to be substituted

Angle brackets

<side> Can in this example be either L (left) or R (right)

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Preface

Preface

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RhinoStream

Contents

Table of Contents Chapter 1 Warnings and Safety Information ...1 1.1 Warnings and Safety Information... 1 1.1.1 Safety in Relation to the Use of Accessory Equipment... 2 1.1.2 Symbols on the Instrument ... 2 1.2 Manufacturer’s Responsibility ... 2 1.3 Contacting Interacoustics... 3

Chapter 2 Getting Started with an SRE2000 ...5 2.1 Introduction to the SRE2000... 5 2.1.1 Hardware Description ... 5 2.1.2 RhinoStream Software Items ... 5 2.1.3 Minimum System Requirements ... 5 2.2 Connecting the SRE2000 ... 6 2.3 Installing the Software on an External PC for SRE2000... 7 2.4 Entering the Software License Code ... 9 2.5 Installing the Hardware Key Separately... 10

Chapter 3 Getting Started with an SRE2100 ...13 3.1 Description of the SRE2100... 13 3.1.1 Hardware Description ... 13 3.1.2 RhinoStream Software Items ... 13 3.2 Connecting the SRE2100 ... 14 3.3 Following the Windows 98 Setup... 14 3.4 Entering the Software License Code ... 15

Chapter 4 Equipment and Maintenance ...17 4.1 Cleaning the SRE2000 and SRE2100 Instruments ... 17 4.2 RhinoStream Accessories and their Care... 17 4.2.1 Cleaning the Silicone Mask... 18

Chapter 5 Initializing and Measuring...21 5.1 Limitations and Sources of Errors... 21 5.2 Assembling the Probe... 21 5.3 Initializing the Manometer Probe ... 24 5.4 Measuring with the Manometer Probe ... 27 5.4.1 Making an Anterior Measurement... 27 5.4.2 Making a Posterior Measurement ... 30 5.4.3 Measuring Using the Silicone Mask... 31 5.5 Saving a Measurement ... 32 5.6 Using the Measuring Functions ... 33 5.6.1 Pausing a Measurement ... 34 5.6.2 Starting a New Measurement Using the same Initialization... 34 5.6.3 Selecting a New Measure Type ... 34 5.6.4 Using Short Cut Keys... 35 5.7 Setting the Program Options... 36 5.7.1 Using the AutoFreeze Function ... 36 5.7.2 Setting the Max Deviation Parameter ... 37

Chapter 6 Analysing Measurements ...39 6.1 Loading an Examination ... 39 6.2 Comparing Examinations for the Same Patient ... 41 6.3 Activating a Curve... 41 6.3.1 Activating a Curve... 42 6.4 Viewing Manometry Data and Curves ... 42 6.4.1 Setting the Reference Pressure... 43 6.5 Working with Curves ... 44 6.5.1 Renaming a Curve ... 44 6.5.2 Deleting a Curve ... 45 6.5.3 Changing a Curve’s Colour and Style... 45 6.6 Zooming ... 46

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6.6.1 Setting the scale on the axes ... 47 6.7 Printing a Graph ... 47 6.7.1 Saving a Graph as it Appears in the Print Preview Window ... 49 6.7.2 Loading a Saved Report ... 50 6.8 Printing Patient Reports ... 50

Chapter 7 Working in the Database ... 53 7.0.1 Database Principle ... 53 7.1 Saving and Loading a Measurement in the Database ... 54 7.2 Working with Patients... 54 7.2.1 Creating a new Patient... 54 7.2.2 Editing Patient Data ... 56 7.2.3 Appending a Patient to an Examination ... 57 7.2.4 Deleting a Patient... 59 7.2.5 Deleting an Examination ... 60 7.3 Diagnosis Options ... 60 7.3.1 Functions in the Diagnosis Data window ... 60 7.3.2 Entering a Diagnosis ... 61 7.3.3 Appending a Diagnosis to a Patient ... 62 7.4 Viewing Patients and Examinations ... 63 7.4.1 Viewing Patient Properties in Advanced View with Comments... 64 7.4.2 Viewing Examinations ... 64 7.5 Sorting Patients and Examinations ... 66 7.6 Grouping and Filtering Patients and Examinations ... 67 7.6.1 Grouping Patients ... 68 7.6.2 Filtering Patients ... 68 7.7 Exporting Data ... 70 7.7.1 Exporting Patients and their Examinations ... 70 7.7.2 Archiving Examinations... 71 7.8 Importing Patients and/or Examinations ... 73 7.9 Changing Unit, Date Formats and Language... 75 7.10 Making a Backup of the Database ... 75

Chapter 8 Hardware Specifications... 77 8.1 Power Supply Cord ... 8.2 Electrical Ratings ... 8.3 Safety Classifications ... 8.4 Environmental Ranges for the Hardware ... 8.5 Viewing the Hardware Settings ... 8.6 Measuring Principle...

77 77 77 78 78 79

Chapter 9 Upgrading the RhinoStream Software ... 81 9.1 Transferring the Contents of the Database when Upgrading... 9.2 Upgrading the RhinoStream Software on an SRE2100 ...

81 82

Chapter 10 Trouble-Shooting ... 85 10.1 Viewing the System Log... 10.2 Trouble-shooting Communication with an SRE2000 ... 10.3 Trouble-shooting Printing ...

85 86 86

Index ... 87

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RhinoStream

Warnings and Security Information

Chapter 1 Warnings and Safety Information IN THIS CHAPTER

This chapter contains important safety information related to the general use of the RhinoStream module. Before use, carefully read this manual, accessory directions for use, all precautionary information and specifications.

1.1 Warnings and Safety Information It is very important that all external equipment that is connected to an SRE2000 or SRE2100 is approved according to the medical directives and complies with the current safety requirements. Connection of an external monitor or a printer to the system must be through a safety transformer. The RhinoMetrics software is to be used with RhinoMetrics hardware instruments ONLY. The manufacturer takes no responsibility for incorrect use or misinterpretations of measurements. The instrument contains no user-serviceable parts. For safety reasons and in order not to void the warranty, only authorised service personnel at authorised workshops should open the instrument. In case of any defects, please make a detailed description of the defect(s) and contact your local distributor. Do not use a defective instrument, sensor or cable. To ensure proper function of the instrument, we recommend that you return the probe annually to your local distributor for inspection and certification. The RhinoMetrics SRE2100 instrument contains lithium batteries, which can explode. Only authorised personnel is allowed to change the batteries. Chemicals from a broken TFT display panel on the SRE2100 are toxic when ingested. Use caution when handling a monitor with a broken display panel. No parts should be eaten, burned or in any way used for other purpose than for rhinomanometry analysis. Keep all parts out of reach of children. Before using the instrument with patients, be sure that you are familiar with the measurement functions. Users should note that monotonous work with any instrument might be dangerous to health. Therefore, if you work for extended periods of time with the instrument, be sure to take breaks and change your work position at regular intervals. Do not base a diagnosis solely on RhinoStream measurements. It is considered a supplementary technique. The manufacturer has taken due precautions to check the software and disks supplied by the manufacturer for known viruses, but it should be noted that neither the manufacturer nor his representatives are liable for the transfer - or damage resulting from such transfer - of any possible virus. Do not attempt to change the Windows operating system from its standard configuration.

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Warnings and Security Information

RhinoStream

The usage of any non-specified off-the-shelf-software on the PC should be prevented to avoid conflicts with the RhinoMetrics device. The RhinoMetrics hardware and software must not be copied. Advice to US users Caution: Federal law restricts this device to sale by or on the order of a physician.

1.1.1 Safety in Relation to the Use of Accessory Equipment The use of accessory equipment not complying with the equivalent safety requirements of the SRE2000 and SRE2100 instruments, may lead to a reduced level of safety of the resulting system. Consideration relating to the choice must include: • Use of accessory in the patient vicinity. • Evidence that the safety certification of the accessory has been performed in accordance to the appropriate EN 60601-1 and/or EN 6061-1-1 Harmonised Standards.

1.1.2 Symbols on the Instrument These security symbols are found on the back panel of the instruments: Type B instrument (IEC 601-1) Attention, consult accompanying documents (IEC 601-1)

1.2 Manufacturer’s Responsibility The manufacturer is considered responsible for the safety, reliability and performance of the instrument, only if: • solely personnel authorised by the manufacturer carry out all assemblies, operations, extensions, re-adjustments, modifications, and repairs. • the electrical installation to which the instrument is connected complies with IEC requirements. • any connected external device is connected using a ground connection and complies with Harmonised Standards EN 60601-1. • the instrument is used in accordance with the this user manual.

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1.3 Contacting Interacoustics In case you have any queries, please contact your local distributor or: Interacoustics A/S Drejervænget 8 DK-5610 Assens Denmark Phone: +45 6371 3555 Fax: +45 6371 3522 E-mail: [email protected] Web site: www.interacoustics.com In case you experience any problems with the RhinoStream program, please send the system log by e-mail to [email protected] together with a description of the problem. For locating the system log, please refer to section 10.1 ’Viewing the System Log’ on page 85.

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Warnings and Security Information

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RhinoStream

Getting Started with an SRE2000

Chapter 2 Getting Started with an SRE2000 IIN THIS CHAPTER

The information in this chapter shows you how to make the SRE2000 ready for use and guides you through the software installation on the connected PC.

2.1 Introduction to the SRE2000 HOW TO GET STARTED

You must perform the following procedures before you can measure with the SRE2000: 1. Connect the instrument to the main power supply and the measuring probe. See “Connecting the SRE2000” below. 2. Install the RhinoStream software on a PC. See “Installing the Software on an External PC for SRE2000” on page 7. 3. Enter the license code for RhinoStream. See section 2.4 ’Entering the Software License Code’ on page 9.

2.1.1 Hardware Description HARDWARE ITEMS

The SRE2000 consists of: • A digital signal processor board and I/O board • Power supply approved for medical application (class IIA) • A USB cable for connecting the user’s PC to the instrument No power cord is supplied, because of the international differences. The COM port on the SRE2000 is galvanic insulated.

ADDITIONAL ITEM

•Software installation CD with hardware key

2.1.2 RhinoStream Software Items The RhinoStream module contains the following items: • A certificate with license code (see section 2.4 ’Entering the Software License Code’ on page 9) • Manual (also available as a pdf-file from the software installation CD-ROM) • User Instructions in the local language (for EU destinations only)

2.1.3 Minimum System Requirements You need a PC to run the RhinoStream program when using an SRE2000. The external PC must meet the following minimum requirements: • IBM compatible PC • Intel 486 (or equivalent) • Clock cycle of minimum 66 MHz • 16 MB RAM (32-64 MB RAM recommended) • 15 MB hard disk space available

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Getting Started with an SRE2000

RhinoStream

• SVGA display adapter (1024x768) • Microsoft Windows 98 English operating system • One available USB port • One CD-ROM drive The PC must be set up according to local regulations. The Rhino software can run on the following Microsoft Windows platforms: WIN98, WIN2000, ME, NT4 and XP

2.2 Connecting the SRE2000 Before connecting the instrument, please note: In accordance with the standard for medical electrical systems UL2601-1 (comprises EN 60601-1-1), the PC to which the SRE2000 is connected, must be at a minimum distance of 1,83 metres from the patient environment. This procedure describes how to connect the SRE2000.

To connect the SRE2000: 1

Insert the USB cable into the USB port of your PC. Note: COM port 1 is the default. If you select another port you must change this setting in the software, see section 8.5 ’Viewing the Hardware Settings’ on page 78.

2

Connect the instrument to the main power supply using an approved power cord, listed in section 8.1 ’Power Supply Cord’ on page 77.

3

Turn the power on. On/off button

USB cable to the external PC

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To connect the SRE2000: 4

Connect the Manometer Probe to the PROBE B input on the front panel of the SRE2000. PROBE B input for P RhinoStream PROBE A input for RhinoScan & RhinoSleep

.

2.3 Installing the Software on an External PC for SRE2000 FUNCTIONS ON THE INSTALLATION CDROM

When you are using an SRE2000, the RhinoStream software must be installed from the supplied software installation CD-ROM on the user’s PC. The CD-ROM contains the following items: Installs the bundled Adobe Acrobat Reader which is necessary for reading or printing the manual Browses the RhinoStream documentation folder, which contains the Help file Browses the RhinoStream Installation Folder

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Runs the installation program

Updates the RhinoStream software

Getting Started with an SRE2000 INSTALLATION OF THE RHINOSTREAM SOFTWARE

RhinoStream

Follow this procedure to make a standard installation of the software:

To install the software: 1

Exit all running Windows applications.

2

Insert the installation CD-ROM in the CD-ROM drive. The installation main window appears.

3

Select Install.

4

The RhinoStream software is now being installed.

a) Follow the instructions for installation on the screen.

b) Click Finish in the Setup Complete window. The Rhino icon is being created on your desktop.

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RhinoStream

Getting Started with an SRE2000

2.4 Entering the Software License Code USE OF LICENSE CODE AND WHERE TO FIND IT

When installing the RhinoStream software for the first time, you need to type in the license code in order to activate it. The license code is written on the certificate delivered together with the software.

LICENSE CODE FORMAT

The license code consists of 8 digits or letters without space. For example: 00AD87DD

ENTERING THE LICENSE CODE

This procedure describes how to enter the license code.

To enter the software license code: 1

Double-click on the Rhino icon.

The Select Measure Type window opens. 2

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Click on the Analysis button.

Getting Started with an SRE2000

RhinoStream

To enter the software license code: 3

Select Tools →Options →Licenses tab.

A red cross next to the RhinoStream text box indicates, that the license code is either incorrect or missing. 4

Type the license code in the RhinoStream text box. When you have entered the code correctly, the red cross changes to a green check mark.

5

Click OK. The RhinoStream program is now activated and ready for use.

2.5 Installing the Hardware Key Separately WHAT IS THE HARDWARE KEY?

The hardware key is specific to the measuring instrument and is provided on the installation CD. The hardware key is necessary for communicating with the DSP board and start measuring. During the normal software installation procedure the hardware key is installed automatically.

WHEN MUST YOU PERFORM THIS PROCEDURE?

This procedure applies to the following situations: • the DSP board in your instrument has been replaced. • the instrument has undergone a hardware update.

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• when several users need access to perform RhinoStream measurements. This is relevant in case the RhinoStream software runs on an operating system with advanced security facilities, such as Windows 2000, NT and XP.

To install the hardware key separately:

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1

Close all Windows applications.

2

Insert the installation CD in the CD-drive

3

Select

4

Click OK. The hardware key is being installed. The Setup window is shown.

5

Follow the instructions on the screen.

Install.

Getting Started with an SRE2000

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Getting Started with an SRE2100

Chapter 3 Getting Started with an SRE2100 IN THIS CHAPTER

The information in this chapter shows you how to make the SRE2100 ready for use.

3.1 Description of the SRE2100 INTRODUCTION

The SRE2100 functions as a complete stand-alone measuring instrument and contains a standard industrial PC.

HOW DO I GET STARTED?

You must perform these procedures before you can start measuring with the SRE2100: 1. Connect the instrument. See “Connecting the SRE2100” below. 2. Follow the Windows 98 setup procedure. See section 3.3 ’Following the Windows 98 Setup’ on page 14. 3. Enter the license code for RhinoStream. See section 3.4 ’Entering the Software License Code’ on page 15.

3.1.1 Hardware Description HARDWARE ITEMS

The SRE2100 consists of: • PC mother board • 2 serial ports • VGA port for connection to an external monitor • Parallel port • Digital signal processor board and I/O board • Power supply approved for medical application (class IIA) No power cord or keyboard are supplied, because of the international differences. The SRE2100 runs on the Microsoft Windows 98 operating system. The RhinoStream software is preinstalled on the computer.

ADDITIONAL ITEMS

• Windows software package with Windows PC Product Key • Hardware disk, also called the hardware key • Mouse and key adapter • Printer cable

3.1.2 RhinoStream Software Items The RhinoStream module consists of the following items: • A certificate with license code (see section 3.4 ’Entering the Software License Code’ on page 15) • Manual (also available as a pdf-file from the installation CD-ROM) with Software Installation CD-ROM (for re-installation) • User Instructions in the local language (for EU destinations only)