Embla Cheyne-Stokes Breathing Analyzer Clinical Manual Rev 1.0 July 2010

Embla Cheyne-Stokes Breathing Analyzer Clinical Manual Applies to RemLogic and RemLogic-E 3.0.1 or higher. Copyright © 2010 Embla Systems. All rights reserved. Issued July 2010. Printed in the USA or The Netherlands. Document Number: D-1004-004, Revision 1.0 Document Item Number: 2861800

For assistance, please contact Embla Technical Support ([email protected]). MANUFACTURER EUROPEAN REPRESENTATIVE Embla Systems Embla Systems Naritaweg 12J 11001 W. 120th Ave., Suite 200 Broomfield, CO 80021 1043 BZ Amsterdam USA The Netherlands Tel: +1.303.962.1800 Tel: +31 20 3460130 Fax: +1.303.962.1810 Fax: +31 20 3460121 TOLL-FREE IN NORTH AMERICA: 888 NO APNEA (888.662.7632) www.embla.com [email protected] [email protected] Copyright Notice No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language or computer language, in any form, or by any means, electronic, mechanical, optical, chemical, manual, or otherwise, without the prior written consent of Embla. In the event this publication is provided in electronic format, the purchaser is permitted to reproduce a copy of the document and/or save the document for archive and reference purposes. Disclaimer This document may contain technical inaccuracies or typographical errors. Changes are periodically made to the information herein; these changes will be incorporated in future revisions of this document. Embla does not accept any liability for the use or misuse, direct or indirect, of this product. Users must accept all responsibility for any results obtained by or concluded from data obtained by the products. The user must accept all responsibility for results obtained by software from Embla. All clinical conclusions and decisions that are made based on the use of this product are the responsibility of the user. Embla does not accept any liability or responsibility for damages arising out of the use of or inability to use this product. Trademarks Embla is a registered trademark of Embla Systems LLC. RemLogic and RemLogic-E are trademarks of Embla Systems LLC.

Embla Cheyne-Stokes Breathing Analyzer Clinical Manual

Contents Warnings and Cautions ...4 Introduction ...5 Definition of Terms ...5 Getting Started ...6 System Requirements ... 6 Installing RemLogic 3.0.1 ... 6

Starting the CSB Analyzer ...8 Generating Reports Containing CSB Statistics ...9 Managing CSB Parameters ... 10 Viewing Default CSB Parameters ...11 Modifying CSB Analysis Parameters ...11

Understanding CSB Associations ... 12 References ... 13

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Embla Cheyne-Stokes Breathing Analyzer Clinical Manual

Warnings and Cautions U.S. Federal law restricts this device to sale by, or on the order of, a physician. It is assumed that the user is familiar with the function and operation of the RemLogic software. It is assumed that the user is trained in the manual classification of sleep stages as described in the 2007 American Academy of Sleep Medicine (AASM) Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications1, before using RemLogic. It is assumed that the user is trained in the detection of specific events in sleep like apnea, hypopnea, and arousal before using the program. For additional information, it is recommended that the reader consult the 2007 American Academy of Sleep Medicine (AASM) Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications1. The user is assumed to know the characteristics of the physiological signals acquired in the polysomnogram. The automatic analysis tools provided in RemLogic are intended to assist in the analysis of polysomnographic data by a physician or trained technician. These tools are not intended to replace the physician or trained technician. Users should always review and understand the results of accurate sleep stage scoring and event marking. RemLogic is intended to assist the physician or trained technician in analyzing and reporting on data collected during sleep studies. Users are solely responsible for all data collected, and are expected to assess and analyze this data to ensure its accuracy and completeness. 0413

RemLogic is certified to carry the CE mark. The CE mark is a declaration that RemLogic is in compliance with the directive set forth by the European Union for medical devices. The Embla Quality Management System complies with EN ISO 13485:2003. RemLogic is manufactured by Embla. Embla certifies that the development, manufacture, sales, and service of RemLogic is in conformity with Annex II of the Directive 93/42/EEC on medical devices. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments.

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Introduction The Embla Cheyne-Stokes Breathing (CSB) Analyzer is an algorithm that detects the typical crescendo and decrescendo waveforms in respiratory recording traces related to the airflow and breathing efforts of a patient. This new algorithm is included in RemLogic and RemLogic-E, version 3.0.1 or higher.

Definition of Terms CS-Cycle is the occurrence of one crescendo followed by one decrescendo followed by one apneic (or hypopneic) change of the breathing waveform. Hyperpneic-Phase is the part of a CS-Cycle characterized as abnormally deep or rapid breathing denoted by the crescendo and the decrescendo change in the breathing waveform. Apneic-Phase is the part of a CS-Cycle characterized by a temporary cessation of breathing (apnea) or abnormally slow, shallow breathing (hypopnea) in the interval between the decrescendo and the next crescendo change in the breathing waveform. Cheyne-Stokes Breathing Sequence (CSB Sequence) is a series of at least three consecutive CS-Cycles. Circulatory Delay is the time from the end of an Apneic-Phase to the lowest oxygen saturation value (also known as the oxygen saturation nadir).

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Getting Started System Requirements The Embla CSB Analyzer is included in RemLogic and RemLogic-E, version 3.0.1. RemLogic 3.0.1 and RemLogic-E 3.0.1 has the same recommended system requirements as RemLogic 3.0 and RemLogic-E 3.0. For more information, consult the system requirements in the RemLogic 3.0 User Manual.

Installing RemLogic 3.0.1 You must log on to your computer with administrator privileges to install RemLogic 3.0.1. Note: If you are using Somnologica 4.0 or earlier and would like to save your custom settings and resources, see Preserving Custom Settings in the RemLogic 3.0 Read Me. For additional assistance, contact Embla Technical Support ([email protected]).



To install RemLogic 3.0.1: 1. Close all programs and log on with administrator privileges. 2. Insert the RemLogic 3.0.1 Installation CD into the CD-ROM drive. 3. On the welcome screen, click Install RemLogic 3.0. 4. The RemLogic Installation wizard is displayed. Do one of the following: •

If you are installing RemLogic 3.0.1 and not upgrading from RemLogic 3.0 (or earlier) or Somnologica 5.0/5.1, click Next.

•

If you are upgrading from RemLogic 3.0 (or earlier) or Somnologica Studio 5.0/ 5.1, click Next, and then proceed to the second bullet of step 6.

5. On the Choose Setup Type screen, click one of the following installation options, and then click Next: •

Typical: Installs features required to acquire, score, analyze, and report PSG data and tools for managing recorded data.

•

Complete: Installs all program features. This option requires the most space on the hard drive.

•

Custom: Allows you to customize the installation and add/remove install components.

6. Do one of the following: •

If you have selected Typical or Complete, proceed to step 7.

•

If you have selected Custom or are proceeding from step 4, click the arrow to the left of the install components you want to add/remove, and then select one of the following options: •

Will be installed on local hard drive. Select this option to install the feature only.

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Entire feature will be installed on local hard drive. Select this option to install the feature and all sub-features.

•

Entire feature will be unavailable. Select this option to remove a component.

Custom install components include (in order of appearance) the CPC Analyzer, CSB Analyzer, Data Management Module, CPAP, Photic, titanium™, Demonstration Device, Generic Export, Scoring Export, CPC Report, Designer Plug-In for Microsoft Office, MWT Report, Inter-Scorer Comparison, CPC Histogram, CPC 3D Spectrogram, Phase View, Timer, and REMbrandt® Viewer. Click Next. 7. Click Install. Windows XP Users: During the Embla titanium software support installation, a warning message (indicating that the drivers have not yet passed Windows Logo Testing) will be displayed twice. To proceed, click Continue Anyway. Windows Vista Users: During the Embla titanium software support installation, a warning message (indicating that Windows cannot verify the publisher of the driver software) will be displayed twice. To proceed, click Install this driver anyway. 8. Click Finish to exit the Installation wizard. 9. Click Exit to close the welcome screen. 10. Restart the computer to complete the installation. 11. If you are not upgrading your system from RemLogic 3.0, the software will ask you to activate the license when you start RemLogic. For instructions, see Activating RemLogic 3.0 in the RemLogic 3.0 Read Me.

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Starting the CSB Analyzer The CSB Analyzer can be used during collection or analysis. By default, the CSB Analyzer automatically selects a trace on which to detect the typical CSB waveform. In order of preference, the CSB Analyzer uses one of the following traces: Tidal Volume (Resp.TidalVolume-Inductive), XSUM (Resp.Sum-Inductive), XFlow (Resp.Flow-Inductive), Thorax Effort (Resp.Movement-Inductive.Thorax), or Abdomen Effort (Resp.Movement-Inductive.Abdomen). By default, the CSB Analyzer uses the Tidal Volume trace derived from the Respiratory Inductance Plethysmography (RIP) belts for the analysis. The CSB Analyzer scores the following events: Apneic-Phase, Hyperpneic-Phase, CS-Cycle, and CSB sequences on the specified trace. You can modify their display properties in the Event Type Properties dialog box. For information on modifying Event Types, see Event Types in the RemLogic Help. You can modify the default analysis parameters of the CSB Analyzer. For information on CSB analysis parameters, see Managing CSB Parameters on page 10. The results from the CSB Analyzer are available in the Cheyne Stokes Breathing Statistics section of the following reports: Sleep Report, Polysomnography Report, CPAP Report, Oxygen Titration Report, Pediatric Report, and SplitNight Report. CSB statistics are also available in custom reports. For information on the CSB statistics reported, see Generating Reports Containing CSB Statistics on page 9. To start the CSB Analyzer: 1. Open RemLogic or RemLogic-E. 2. Open a patient recording. 3. On the Analysis menu, click CSB Analyzer.



Note: If the Select Trace Automatically is set to No in the Analysis Settings for CSB parameters or the CSB Analyzer did not detect one of the preferred respiratory signals, you must specify the trace on which the CSB Analyzer detects the CheyneStokes Breathing waveform. You can run the CSB Analyzer on any trace with a Resp. trace type, excluding Resp.Phase, Resp.Rate, Resp.Snore, and Resp.TidalVolume-Flowgenerator.

4. If necessary, click the trace on which you want the CSB Analyzer to detect the Cheyne-Stokes Breathing waveform.

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Generating Reports Containing CSB Statistics Several reports contain CSB statistics: Sleep Report, Polysomnography Report, CPAP Report, Oxygen Titration Report, Pediatric Report, and Split-Night Report. In order for Circulatory Delay statistics to appear in the report, you must score Desaturation events. You must also run the Associations module to associate the Apneic-Phase with the Desaturation event. In the Association Settings, the Apneic-Phase is associated with Desaturation by default. The Association module reevaluates automatically for Desaturation associations after you run the CSB Analyzer. For assistance scoring Desaturation events, run the Respiration Analyzer found under the Analysis menu. The Respiration Analyzer will automatically identify SpO2 desaturations based on the parameter settings. For more information, consult the RemLogic Help. To generate a report containing CSB statistics: 1.

Score Desaturation events or run the Respiration Analyzer. In the RemLogic Help, see Starting the Respiration Analyzer.

2.

Run the CSB Analyzer.



Note: By default, the Association module automatically checks for associations between the Apneic-Phase and Desaturation event after you run the CSB Analyzer. If you have turned off the feature in the Association Runtime Settings to re-evaluate associations after you run the CSB Analyzer, you must update all associations.

3.

If necessary, update all associations. In the RemLogic Help, see Starting the Association Analyzer.

4.

On the Reports menu, click Sleep Report, Polysomnography Report, CPAP Report, Oxygen Titration Report, Pediatric Report, or Split-Night Report. Tip: In order for Circulatory Delay statistics to appear in the report, you must have Desaturation events and Apneic-Phase - Desaturation associations in the study.

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Managing CSB Parameters The table below lists the CSB parameters, their function, and default value: Parameter Name

Function

Default Value

Range

Select Trace Automatically

Defines whether the trace used for CSB analysis is selected automatically (Yes) or manually (No).

Yes

Yes No

If you select Yes, the analyzer will choose, in order of preference, one of the following traces on which to detect the typical CSB waveform: Tidal Volume, XSUM, XFlow, Thorax or Abdomen Effort. By default, the CSB Analyzer uses the Tidal Volume trace derived from the Respiratory Inductance Plethysmography (RIP) belts for the analysis. If the analyzer does not find any of the preferred traces in the recording or you opt to manually choose the trace, the analyzer will prompt you to choose from a list of available channels. T2

120 seconds

0 – 240 seconds

50 %

30 – 99 %

T2 is the maximum interval in seconds between two CS-Cycles for inclusion in a CSB Sequence. If a CS-Cycle occurs within the maximum interval, the CS-Cycle is included in the CSB Sequence. If a CS-Cycle occurs after the maximum interval, the CS-Cycle is not included in the CSB Sequence and the CSB Sequence ends. In the example above, the next CS-Cycle occurs within the maximum interval, so it is included in the on-going CSB Sequence, denoted by the long blue bar at the top of the screen capture. Minimum Decrease

The Minimum Decrease is the minimum percentage decrease in the peak to peak signal amplitude of the Hyperpneic-Phase to detect the start and end of the Apneic-Phase of the CS-Cycle. The CSB Analyzer uses the five highest signal amplitudes in the Hyperpneic-Phase to calculate an average baseline for the Hyperpneic-Phase. The Minimum Decrease is measured from this baseline. The CSB Analyzer dynamically calculates the average baseline and the Minimum Decrease for each CS-Cycle. By default, the CSB Analyzer will detect the start and end of the Apneic-Phase of the CS-Cycle when the breathing signal amplitude is 50% of the average baseline for the Hyperpneic-Phase.

Flow Noise Level

The Flow Noise Level is the minimum signal threshold for valid breathing.

2%

0 – 50 %

Minimum Apneic-Phase Duration

Minimum Apneic-Phase Duration specifies the shortest duration allowed for an ApneicPhase event.

3 seconds

1 – 30 seconds

Minimum Number of Cycles in CSB Sequence

The Minimum Number of Cycles in CSB Sequence is the minimum number of consecutive CS-Cycle with an interval less than T2 required to mark a CSB Sequence event.

3

2 – 50

For instructions on modifying these parameters, see Modifying CSB Analysis Parameters on page 11.

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Viewing Default CSB Parameters You can view the default CSB parameters settings in the Analysis Settings dialog box. To view default CSB parameter settings: 1. On the Analysis menu, click Settings. 2. If necessary, from the Profile list, click Default (Read Only). 3. In the left pane, click CSB. 4. Do one of the following: •

To see General parameters, click General.

•

To see Analysis parameters, click Analysis.

Modifying CSB Analysis Parameters You can create custom CSB analysis parameters settings in the Analysis Settings dialog box. To modify CSB parameter settings: 1. On the Analysis menu, click Settings. 2. From the Profile list, click Custom. 3. In the left pane, click CSB. 4. Do any of the following: To

Do This

Allow the software to automatically detect the trace to be used for CSB analysis

In the left pane, click General. For the Select Trace Automatically value, click Yes.

Allow the user to manually select the trace for CSB analysis

In the left pane, click General. For the Select Trace Automatically value, click No. In the left pane, click Analysis. For the T2 value, type a number between 0 and 240. In the left pane, click Analysis. For the Minimum Decrease value, type a number between 30 and 99. In the left pane, click Analysis. For the Flow Noise Level value, type a number between 0 and 20. In the left pane, click Analysis. For the Minimum Phase Duration value, type a number between 1and 30.

Modify T2 Modify the Minimum Decrease Modify Flow Noise Level Modify the Minimum Apneic-Phase Duration

Modify the Minimum Number of Cycles in CSB Sequence

In the left pane, click Analysis. For the Minimum Number of Cycles in CSB Sequence value, type a number between 2 and 50.

5. Click Close. Caution: Review all the events scored by the CSB Analyzer for their clinical significance. This practice is recommended by the AASM and Embla Systems to ensure the accuracy and consistency of the results.

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Understanding CSB Associations In RemLogic, there is only one default CSB Association in the Association Settings: the Apneic-Phase is associated with Desaturation. Once you run the Respiratory Analyzer to score Desaturation and the CSB Analyzer to detect the typical CSB waveform, you can run the Associations module to detect whether there is a Desaturation event in close proximity to an Apneic-Phase event. By Default, the Associations module searches for the end of a Desaturation event within 30 seconds of the end of an Apneic-Phase event. RemLogic uses the results of this association to calculate Circulatory Delay statistics for reports. By default, in the Association Runtime Settings, the Association module automatically checks for associations between the Apneic-Phase and Desaturation event after you run the CSB Analyzer. For assistance modifying association settings and association runtime settings, see the following topics in the RemLogic Help: Event Associations, Event Association Parameters, Subclassifications, and Association Runtime Settings. Caution: RemLogic uses the results from the Phase-Desaturation association to calculate Circulatory Delay statistics for reports. Changing the default CSB Association may affect the reported values for Circulatory Delay and may produce results different from those validated from independent research.

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References 1. Iber C, Ancoli-Israel S, Chesson A, Quan S. The American Academy of Sleep Medicine (AASM) Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications. 2007 American Academy of Sleep Medicine, USA

References y Page 13 of 14

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