VivoSense. User Manual - LifeShirt Import Module. Vivonoetics, Inc. San Diego, CA, USA Tel. (858) , Fax. (248)

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VivoSense User Manual - VivoSense LifeShirt Import Version 3.0 Vivonoetics, Inc. San Diego, CA, USA Tel. (858) 876-8486, Fax. (248) 692-0980 Email: info@vivonoetics.com; Web: www.vivonoetics.com

Cautions and disclaimer VivoSense software is not a medical diagnostic tool and is intended for research and investigational purposes only. VivoSense is not intended to be, or to replace, medical advice or review by a physician. Copyright Notice Copyright 2016 Vivonoetics. All rights reserved. Page 2 of 10

Table of Contents 1. Introduction... 4 1.1. VivoSense for LifeShirt... 4 1.2. System Requirements... 4 2. Importing Data... 5 2.1. VL Batch Import... 5 3. Processing Data Channels... 6 3.1. Accelerometer Data Channels... 6 3.2. Electrocardiogram (ECG) Data Channels... 6 3.3. Galvanic Skin Response (GSR) Data Channels... 7 3.4. Pulse Oximeter Data Channels... 7 3.5. Respiration Data Channels... 7 4. Annotations... 9 5. Layouts... 10 Page 3 of 10

1. Introduction 1.1. VivoSense for LifeShirt This manual describes the use of the LifeShirt import module for VivoSense. This module is specifically used to import and analyze data collected with the LifeShirt sensor system by VivoMetrics. 1.2. System Requirements The LifeShirt Import module is an add-on module to VivoSense software. In addition to the VivoSense requirements, the LifeShirt import module has the following system requirements: VivoLogic software must be installed on the same computer as VivoSense CompactFlash memory card reader To read files directly from device storage Page 4 of 10

2. Importing Data Ambulatory physiological data recorded using the LifeShirt system is stored as a.w file on the LifeShirt recorder CompactFlash storage card. These files can be accessed or transferred to a PC using a standard CompactFlash card reader. Alternatively, if VivoLogic software has already been used to convert raw LifeShirt files to.viv files, these.viv files may be converted to VivoSense files for further analysis. 2.1. VL Batch Import VivoSense works in conjunction with the VivoLogic application to extract data suitable for import to VivoSense. After installing the, the VivoSense File -> Import Hardware File menu will have the following two menu command options: LifeShirt Raw File Use this to import *.W, or *.waveform files LifeShirt Data File Use this to import *.viv files LifeShirt Raw File LifeShirt Raw data files contain only the original un-calibrated data recorded using the LifeShirt system. VivoSense will instruct VivoLogic to perform a QDC calibration before exporting respiratory data into VivoSense. On import, VivoSense will then perform two auto-calibrations. One calibration scales Vt and the other shifts accelerometer data (for details refer to the VivoSense Core manual). LifeShirt Data File LifeShirt Data files (paired *.viv and *.vov files) contain all user annotations and calibrations performed by the user after the raw data was originally imported into VivoLogic and prior to import into VivoSense. In this instance, auto-calibrations are performed to shift accelerometer data but not to scale Vt. In addition, both user and hardware annotations are imported to VivoSense. Page 5 of 10

3. Processing Data Channels Available data channels from LifeShirt devices fall in two categories: Raw data channels imported from the device and derived channels as calculated by VivoSense. Raw data channels from LifeShirt are located in the Data Explorer under the Raw node. They include Waveforms data channels, as described in the following sections. All Raw LifeShirt data channels are labeled with the prefix LS_ in VivoSense to indicate that their source is a LifeShirt system. For more information regarding these data channels, please consult the hardware documentation for the LifeShirt system. The core VivoSense manual contains a general description of the derived channels. Only the derived channels that are specific to the LifeShirt system are described here. 3.1. Accelerometer Data Channels The LifeShirt accelerometer measures acceleration along 3 axes denoted by CH7, CH8 and CHE. The raw data is measured in computer units (cu) with an arbitrary offset. The conversion to physical units is performed in the derivation of the core accelerometer channels (AccX, AccY and AccZ). This calibration is done automatically on import and assumes the subject is upright at least once during the course of the session. See the VivoSense core manual for information about axis definitions. Raw Accelerometer Waveforms LS_CH7 Acceleration, measured along the Vertical Axis (Source Channel of AccZ). LS_CH8 Acceleration, measured along the Lateral Axis (Source Channel of AccY). LS_CHE Acceleration, measured along the Longitudinal Axis (Source Channel of AccX). Please note that this channel is absent in LifeShirt Model 100 system. The LifeShirt Model 100 unit supports a two-channel accelerometer only. 3.2. Electrocardiogram (ECG) Data Channels The LifeShirt system provides a modified limb II electrocardiogram (EGC) measurement. VivoSense will process this ECG and perform QRS detection to generate a set of R-wave markings Raw Electrocardiogram Waveforms LS_CH1 Primary raw ECG signal Page 6 of 10

3.3. Galvanic Skin Response (GSR) Data Channels The LifeShirt system allows for the connection of an optional sensor for measuring Galvanic Skin Response (GSR). The source of this data may be from hardware port A or hardware port B. The following waveforms are included in VivoSense: LS_GSR~a This is the raw GSR waveform if the GSR sensor was connected to the recorder port A. LS_GSR~b This is the raw GSR waveform if the GSR sensor was connected to the recorder port B. GSR This is the calibrated GSR waveform in µsiemens independent of which port the waveform was connected to. 3.4. Pulse Oximeter Data Channels The LifeShirt system allows for the connection of an optional Pulse Oximeter sensor for measuring oxygen saturation. The following measures are included in VivoSense: LS_Sa02~s This is the raw oxygen saturation measure imported directly from VivoLogic. SaO2 This is a copy of the oxygen saturation measure where dropouts of less than 3 seconds are replaced with the previous good oxygen saturation value. A dropout is defined as a saturation value that is less than 70%. This helps to visualize the measure in the presence unwanted dropouts. 3.5. Respiration Data Channels The LifeShirt system uses a dual band Respiratory Inductance Plethysmograph (RIP) technology to record raw channels of respiration. Raw Respiration Waveforms LS_CHA This is the RIP band respiration waveform measured across the rib cage. Chest excursions are measured in uncalibrated computer units LS_CHB This is the RIP band respiration waveform measured across the abdomen. Abdominal excursions are measured in uncalibrated computer units. LS_Vt This is the weighted sum of LS_CHA and LS_CHB. The value of the weighting coefficients are the result of the calibration. In the case of a.w file import, the calibration is performed automatically over the entire file Page 7 of 10

while in a.viv file import, no additional calibration is performed. Instead VivoSense retains the same calibration settings that were stored the last time the.viv file was opened in VivoLogic. Page 8 of 10

4. Annotations VivoLogic supports several types of annotations. The annotations entered via the LifeShirt recorder during a recording session are imported as hardware annotations. All other annotations, such as general user annotations, annotations which identify the location of the data used by a calibration calculation (such as QDC calibration, Fix Volume calibration, posture calibration) or annotations identifying specific events such as apneas, hypopneas, alpha intrusions are imported as user annotations. All annotations are user editable after import into VivoSense. Please note, however, that any user modification will not result in changes to the output of an underlying algorithm. Page 9 of 10

5. Layouts VivoSense software provides a variety of Layouts specific to the LifeShirt Import module. The following layouts are provided with the LifeShirt Import module: Actigraphy These Charts are suitable for evaluating the motion and/or activity of a subject. This layout contains channels for each calibrated accelerometer axis as well as derived posture and motion measures. Breath Detection and Calibration This is a specific set of Charts designed for adjusting the breath detection settings and calibrating the Vt waveform. All of the charts necessary for the examination of changes in breath detection are available. This layout also provides easy access to the Breath Detector channel (for adjusting breath detection settings) as well as the Calibration Volume channel (for performing a fixed volume calibration). Changing the Breath Detection settings will result in changes in respiratory measures and their corresponding trends Cardiac This is a set of Charts suitable for use in evaluating cardiac information from an electrocardiogram (ECG) sensor. This layout contains the filtered ECG waveform, R-wave markings resulting from QRS detection and subsequent derived R-R intervals. A trend of the heart rate is included along with accelerometer waveforms to be used for context interpretation and identification of artifact. If necessary this layout may be used for making changes to the R-wave picker settings. Quality Control This set of Charts is the most general and is suitable for evaluating the quality of recorded data. It contains waveforms and measures from the respiration, electrocardiogram and accelerometer data channels. It is not however a complete set of measurements from all channels. Raw LS Waveforms This is a set of Charts that contain all the raw (non-optional) data from the LifeShirt system. It is always important to visually examine raw data to account for possible sensor artifact. This layout does not contain charts for the optional pulse oximeter, EEG and GSR channels. Respiration This is a set of Charts suitable for evaluating respiratory data and contains several key respiratory measures and trends. The Vt waveform with breath detection markings, as well as respiration trend channels. Sleep This is a set of Charts suitable for use when evaluating sleep data and contains respiratory waveforms and measures, motion and posture data, as well as oxygen saturation data. Page 10 of 10