Integration of the new miniaturized pneumotachograph for SOMNOscreen plus (Item no.: SEN513)

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Software-News DOMINO 2.7.0 July 2015 The latest DOMINO version 2.7.0 comes with a handful of new features, allowing a high quality, user-friendly collection and analysis of the ambulatory PG and PSG recordings with the SOMNOscreen and SOMNOscreen plus. Integration of the new miniaturized pneumotachograph for SOMNOscreen plus (Item no.: SEN513) The existing pneumotachograph (Item no.: SEN510) for SOMNOscreen plus is expensive and not very handy. The disinfection of the device is difficult because of the measuring method. Moreover, its application is only possible close to the PAP-device. The new generation of the miniaturized pneumotachograph has an advanced design and measurement principle. It is only half the size and half the weight of its predecessor. This allows for a more comfortable assessment of respiratory volume and leakage during CPAP/BiPAP conditions. Because of the reduced size, an application close to the CPAP mask is now possible. The flow resistance remains the same as in the preceding model. However, this is now realized by a decrease in cross section. Due to the new measuring method the system can easily be cleaned. The set contains the lighter and smaller pneumotachograph, a revised differential pressure sensor, a short tube for the connection of CPAP/ BiPAP devices and color-coded silicon connection tubes. The analysis of mask leakage is independent of the type of mask and PAP device used. Therefore we have a flexible system. The standard montage for measurements with the pneumotachograph has been updated in order to guarantee a user-friendly handling (only in new installations). Additionally, when zero calibration is missing, a message is displayed as well as a warning in the corresponding section of the report. Topics in this volume Integration of the new miniaturized pneumotachograph...1 Connection of the Home Sleep Camera (VID98)...2 New Analyses: Automatic detection of autonomic arousal...2 Automatic detection of RERAs...4 Apnea prior Hypopnea...5 Integration of external battery pack for SOMNOscreen plus...5 Automatic tracking with User Manager...5 Simplified Handling of the DOMINO Software...6 Improvement of the BP determination...6 Simplification for quick editing...7 Improvements for Routine EEGs...8 Further improvements at a glance...9

Connection of the Home Sleep Camera (Item no.: VID98) The Home Sleep Camera can be used with the DOMINO software for cardiorespiratory screenings and polysomnographic recordings with SOM- NOscreen plus in a home environment. The camera has a resolution of 800x600 pixels and an integrated IR illumination for optimal night vision. A microphone is integrated in the camera case for acoustic recordings during the night. The set also contains a tripod for optimal adjustment of the Home Sleep Camera. When initializing a measurement with an automatic start time, the camera recording can be programmed as well. This way the measurement and video data are recorded synchronously. The video recording starts automatically, this ensures that the camera is easy to use. After transfer of data, the video can be imported into the measurement. We guarantee a maximum shift of 1 second between raw data and video recording during 8-hour recording. New analyses 1. Automatic detection of autonomic arousal in PG and PSG With PG recordings where EEG recordings are generally not required, or in PSG recordings with too many artefacts, the following evaluations cannot be completed: 1) There is no option to score a hypopnea associated with arousal, even though this is a criterion according AASM Manual version 2.1 (2014). 2) Respiratory Effort Related Arousal (RERA) is a respiratory, sleep fragmenting event requiring an arousal by definition. However, RERAs cannot be edited because the underlying cause of the arousal is missing. 3) For the same reason, it is also not possible to indicate the Respiratory disturbance index (RDI) in the report (because RERA cannot be determined the RDI is the sum of all apneas, hypopneas and RERAs per hour of the total sleep time). 4) It is not possible to find out whether an arousal is caused by a respiratory event or by a PLM event. 5) The observation of sleep fragmentation is also based on cortical arousals. If these are missing, the amount of undisturbed sleep intervals cannot be assessed in the total sleep time. page 2

To detect autonomic arousal, the software analyzes drops in pulse wave amplitude (PWA) of the photoplethysmography-signal. According to a study by Zacharias et. al.*, respiratory events not only induce EEG Arousals but also sudden, temporary changes in autonomic markers such as photoplethysmography-signal caused by an activation of the autonomous nervous system. Thus, drops in pulse wave amplitude are a reliable indicator of the occurrence of autonomic arousal. The automatic detection of autonomic arousals complements Sleep FFT Analysis in terms of arousal detection. Accordingly, if the EEG recordings cannot be regarded, for example, in the case of a PG recording or a recording with high EEG artefacts, arousal can be evaluated without EEG recordings now. For the first time, it is also possible to determine sleep fragmentation in PG recordings based on autonomic arousal found in photoplethysmography-signal. In addition, the arousal criterion can be applied for hypopneas in PG recordings without EEG recordings. The classification of autonomic arousal works analogous to the cortical arousal. Thus, autonomic arousal can be traced to PLM events or respiratory events. * ZACHARIA, André, et al. Sleep apnea syndrome: improved detection of respiratory events and cortical arousals using oxymetry pulse wave amplitude during polysomnography. Sleep and Breathing, 2008, 12. Jg., Nr. 1, S. 33-38. page 3

2. Automatic detection of RERAs AASM leaves it to the physician to report the Respiratory disturbance index (RDI). This parameter is calculated from the sum of apneas, hypopneas and Respiratory Effort Related Arousal (RERA) per hour total sleep time. Up to now, RERA needed to be edited manually as the DOMINO software did not provide an automatic analysis. According to AASM, RERA is a respiratory event, which does not meet the apnea or hypopnea definition, but is characterized by an increased respiratory effort leading to arousal. DOMINO 2.7.0 now recognizes such periods of increased respiratory effort followed by an arousal and automatically assigns the appropriate RERA. RERA with cortical arousal. The increased respiratory effort is detected in the thoracic breathing effort. The RERA is marked as respiratory event in the flow channel. Using DOMINO 2.7.0, either cortical arousal in EEG and EMG channels or autonomic arousal can be used for the automatic detection of RERA. RERA with autonomic arousal. The increased respiratory effort is detected in the abdominal breathing effort. The RERA is marked as respiratory event in the flow channel. page 4

3. Apnea prior Hypopnea Often the software recognized hypopneas instead of apneas, due to the existing rule which evaluates respiratory events and determines which correlated best with the duration of desaturation. According to AASM Manual version 2.1 (2014), apnea needs to have a higher priority than hypopnea if a portion of the respiratory event meets the criteria for apnea. Using the checkbox Apnea prior Hypopnea which has been added to the Flow Analysis of DO- MINO 2.7.0, a respiratory event will be scored as apnea if it meets both criteria for hypopnea and apnea. The analysis of PG and PSG recordings is carried out according to the criteria of the AASM Manual. Integration of external battery pack for SOMNOscreen plus (Item no.: SSC057) For 72-hour offline recordings and 24-hour online recordings with SOM- NOscreen plus, the external battery pack has been added to DOMINO 2.7.0. Automatic tracking with User Manager In general, the User Manager allows one to assign and manage access rights for different users. This means that functions such as the analysis of measurements or the access to the Global Preferences can be excluded for specific users. So far, traceability with changes done by different users was not possible. With activated User Manager, date, user and performed action are now tracked when a recording is done, edited and completed. Thus, every single recording has its own logbook for all changes. The last editor of a measurement can easily be traced in the Open dialog. The current editor can quickly be identified in the report. In addition, the User Manager of DOMINO 2.7.0 allows assigning the right to carry out the function Mark as complete measurement. page 5

Simplified Handling of the DOMINO Software The general performance of the analysis software DOMINO has increased due to the increasing number of different analyses available. Especially unexperienced users may have difficulties in using the software. For a simplified handling, the primary parameters of every analysis are illustrated by simple and userfriendly buttons. All secondary parameters have been moved to a sublevel area which can be accessed and adjusted via the button Advanced analysis settings. The time frames for the classification of events such as Arousal, PTT decreases and BP rises with events from other channels (Flow, PLM, HR and Snore) are visualized. This software simplification leads to user-friendly, self-explanatory, time-saving handling of DOMINO. Improvement of the BP determination When performing long-term BP measurements, distinct deviations in PTT values may occur under certain circumstances leading to unnatural physiological, beat-to-beat deviations of the BP. Our studies show that even on the finger slight reflections of the pulse wave occur distorting the shape of the pulse wave. The FFT-Average of the plethysmography signal in the Pleth Analysis in DOMINO provides a powerful patented algorithm to improve blood pressure determination. The elimination of the reflected wave will reduce derivations of the BP results significantly. page 6

Simplification for quick editing Due to the large number of possible analyses with our DOMINO software the list of events for which a shortcut key can be assigned is very long. From time to time the search for the needed shortcut key can take a while. With DOMINO 2.7.0 the most important shortcut keys can be saved as favorites. This ensures a quick access to the most frequently used shortcut keys. Within an open recording the saved favorite shortcut keys are displayed in a window in the toolbar. In addition, there is now a one-click-function available to edit events (Respiratory events, classified Arousals). Using the Quick Edit mode, these events will be marked with minimum duration after one mouse click in the corresponding raw data channel. This new function enables measurements to be edited by a time-saving means within the Edit mode. page 7

Improvements for Routine EEGs 1. Impedance check (EEG check) for EEG Reference electrode Preferably before the start of an online recording, but also during the measurement, the impedance check of EOG- and EEG- channels can be performed. The signal quality of the reference electrode is now detected as well and displayed with color indicators. One can see the reasons for bad impedances at a glance. 2. Hyperventilation Maneuver DOMINO 2.7.0 includes a stop watch function for online recordings. This function can be defined for specific markers in the Global Preferences (Edit Marker). When activating the marker, the stop watch will be started and stopped automatically depending on the predefined settings. The period in between is displayed accurately to the second. 3. Raw data of the Photic Stimulator During the online recording the signal of the photic stimulator (Item no.: EXT008) is displayed and stored in its own separate channel. 4. Display of maximum EEG amplitude According to neurological requirements the maximum EEG amplitude is calculated by measuring the maximum signal amplitude of the perpendicular of the peak of the signal where it meets the connecting line between starting and end point of the increase of the signal. When marking a certain period within the EEG signal, the maximum EEG amplitude will be shown in an info box of the mouse cursor. page 8

Further improvements at a glance Hide Events during wake available for additional analysis: If the feature Hide Events during wake is activated, no events that have been detected during wake by the automatic analysis will be displayed. Manually edited events during wake are not hidden. This feature is now also available for the following analyses and the resulting analysis channels: SpO2 Analysis, Heart Rate AASM Analysis, Snore Analysis, Cheyne-Stokes Analysis, LM Analysis, PTT Analysis, PTT Classification, Classification Systolic, Phase Angle Analysis and Arousal Classification. Improvement of the Tilt Table Report: To investigate the occurrence of syncope due to a dysregulation of the circulatory system, tilt table check-ups are performed. For a detailed evaluation, the tilt table report provide a tabular overview of blood pressure, heart rate, oxygen saturation and body position in 15-second intervals. The maximum display time is one hour. Export to Excel of analysis data: All analysis data are exported to a single Excel file, with a separate spreadsheet for each analysis channel. The Excel export can be done either for the entire measurement, a selected section, or for a separate area. Advanced functions of the EDF-export: Simultaneous EDF+ export of multiple measurements need to be selected in the measurement directory of the open dialog. Subsequently, the pop-up menu of the open dialog opens by rightclicking and the EDF + export can be carried out as usual. In addition, the EDF+ export can now also be carried out automatically after finishing the online recording. In order to do this, a template and a directory must be deposited when preparing an online recording. Improved use of samples: In order to quickly and easily store samples of raw data and analysis data during the editing of a measurement, samples can be saved using a drop-down menu with pre-defined names. Additionally, a key combination for automatically storing raw data samples can be defined in the Global Preferences. The deposited samples can be opened for preview and editing in the DOMINO Report Generator before selecting them for the report. Report printout in portrait and landscape format: The DOMINO Report Generator offers the option to select whether the summary graphic is displayed in portrait or landscape format before creating the report. License Server: The management of software licenses can be carried out centrally by means of the license server, so that the DOMINO software can be used in multiple places simultaneously depending on the number of existing licenses. page 9

Further improvements at a glance Integration of ResMed therapy devices of Air 10 series via TxLink Filter optimization with simultaneous reduction of analysis time Password request when terminating a measurement Creation of automatic analysis as auto -Inter Scorer Archiving of additional measurement data on previously completed CDs/DVDs Adjustments according to AASM Manual version 2.1 (2014).. and much more! The functionality of DOMINO Software version 2.7.0 was tested and verified for the operating systems Windows XP (32/64 bit) with Service Pack 3, Windows 7 Professional (32/64 bit) and Windows 8 / 8.1 (32/64 Bit). Contact and Furhter Information SOMNOmedics GmbH Am Sonnenstuhl 63 97236 Randersacker Germany www.somnomedics.eu +49 931-359094-0 +49 931-359094-49 info@somnomedics.eu SOMNOmedics Innovative Solutions for Sleep Diagnostics and therapy page 10