Inncor Software Release Information ver 8.10

Innovision

Innocor® Software Release Information – for version 8.10

1

UPDATE TO VERSION 8.02

1.1

LCI UPDATE

1.1.1 On-line calculation of flow-gas delay The dead space of the new smaller respiratory valve unit (Compact RVU, see below) is so low that it allows the software to calculate the flow gas delay on-line during the washout in most cases. One averaged flow gas delay is used for each washout manoeuvre. This means that the operator doesn’t need to calibrate the flow gas delay in advanced, when using the Compact RVU.

The calibration status of the flow-gas delay calibration will be shown as a green check mark with a small yellow triangle warning during preparation (see below), which will disappear after a successful LCI test. If no valid flow gas delay calibration is found during the LCI test due to very weak breathing, the test is stopped and the operator is prompted to do a manual flow gas delay calibration.

1.1.2 Normal values The LCI results support now normal values on the Results screen and in the detailed view. At present only reference values for LCI and FRC are implemented in the Innocor s/w for children < 19 years according to “Age and height dependence of lung clearance index and residual capacity, ERS 2013, Lum et al”. Adults can be added in C:InnocorSetuppredictedValues.xml.

October 2018

SRI-029, Rev. 01

1

Innovision

Innocor® Software Release Information – for version 8.10

Max deviation against median (absolute / in %) Normal value / in % SD of FRC (absolute / in %) Max deviation against median (in %) Normal value / in %

The detailed screen contains also information about the max deviation of the LCI’s and FRC’s against the median as well as SD on the FRC’s.

1.1.3

Calculation of LCI

1.1.3.1 Selection of best manoeuvres The selection of best manoeuvres has been updated to be in accordance to ERS/ATS standards. The following rules are applied: - Manoeuvre where FRC differs more than 25% from median FRC shall be excluded. - Manoeuvre where FRC differs more than 4.88% from mean FRC shall be excluded, if number of manoeuvres after exclusion is 3 or more. - Manoeuvre where LCI differs more than 10% or 1 TO in relation to median LCI (whichever is largest), shall be excluded, if number of manoeuvres after exclusion is 3 or more. If only two results exist, the median is the average of the two results. October 2018

SRI-029, Rev. 01

2

Innovision

Innocor® Software Release Information – for version 8.10

However the user can still overwrite the selection of best manoeuvres.

1.1.3.2 Number of good manoeuvres Previous version of Innocor software accepts an LCI test if 2 good manoeuvres were found. The new version requires 3 good manoeuvres to be in accordance to ERS/ATS standards. However it is possible to manual overwrite the required number of good manoeuvres in LCI.ini. [LCI] NoAcceptTests=3 2: requires 2 good manoeuvres (previous default) 3: requires 3 good manoeuvres (default)

1.1.3.3 Interpolation at LCI point As default the Innocor software calculates the LCI point as an interpolation between the breath before and after 1/40. An alternative method is also supported, where the LCI point is set to the first breath after 1/40. This method is however less stable and can increase the LCI by 0.2-0.3. The calculation is defined in LCI.ini: [LCI] Interpolation=1 0: the LCI point is found as the first breath after 1/40 1: the LCI point is found by interpolation between the breath before and after 1/40 (default) 1.1.3.4 LCI at mouth or at sampling point Further the Innocor calculates the LCI as default at the air opening (at the mouth) - LCIao. An alternative method is also supported, where the LCI is calculated at the gas sampling point - LCIgs. The difference in the two methods are the amount of instrument dead space subtracted, when calculating the VCE. LCIao uses the dead space from the mouth to air, i.e. the sum of pre-capillary and post-capillary dead space. LCIgs uses the dead space from the capillary to air, i.e. the post-capillary dead space. The difference between the two methods are 2-6% depending of equipment DS. (Note the calculation of FRC uses always the dead space from the mouth to air, i.e. the sum of precapillary and post-capillary dead space). The calculation is defined in LCI.ini: [LCI] CalcATmouth=1 0: LCIgs 1: LCIao (default) 1.1.4

Graphical update

1.1.4.1 Flow-volume curve The display of breathing volume can be changed by pressing the graph. The display will toggle between 3 different displays shown below:

October 2018

SRI-029, Rev. 01

3

Innovision

Innocor® Software Release Information – for version 8.10

1.1.4.2 Identification of expirations and end-tidal The washout curve supports now the identification of the expirations periods and the SF 6-ET’s can be shown too.

Double-click on an expiration will display a detailed plot of the expiration with respect to flow and gas. If the VT of a breath is higher than the instrument dead space and lower than 50 ml (default value) the expiration will be marked as yellow, and the SF6-ET of this breath will be ignored. However, the 50 ml is lower than the dead space of the valve (55 ml for the Compact RVU and 165 ml for the Standard RVU), so this will not happen - unless the configuration file is modified with respect to the 50 ml (LCIMinVTaccept). The post gas sampling-point dead space of the Compact RVU (the dead space between the gas sample line and air) is very low (5 ml), and in some cases the subject makes some small flow fluctuations at the end of an expiration resulting in a dip in the SF6 curve. Such a dip is real, but the software is insensitive to this dip when calculating the SF 6-ET.

October 2018

SRI-029, Rev. 01

4

Innovision

Innocor® Software Release Information – for version 8.10

1.1.5 Setup of breathing guidance The minimum and maximum VT of the breathing guidance can be setup in the Test Param. The minimum VT can be one of the following: - value in ml (default 400 ml) - 7 ml x weight in kg - 2 x instrument dead space

Below the breathing guidance is shown with minimum and maximum VT: Maximum VT Last total inspired volume Target inspired volume Actual inspired volume Minimum VT

The target VT/inspired volume, the bolus fraction and the bag volume can be selected prior to the LCI using 4 different methods: - Auto: The previous method, where the VT is detected prior to the test, and the bag adjusted by a scaling factor. - Fixed: The user enters the VT, bolus and the bag volume manually. - Predicted: The VT, bolus and the bag volume are defined based on a recommended table based on age. - Previous: The VT, bolus and the bag volume are set similar to what was used in the last test.

October 2018

SRI-029, Rev. 01

5

Innovision

Innocor® Software Release Information – for version 8.10

Example of recommended table used in the prediction method:

1.1.6

Support for external screen

1.1.6.1 Breathing guide on external screen The breathing guide can be shown on a secondary screen, if available. The button “Guide on/off” is used to switch it on/off. The “Guide on/off” button is only enabled, if supported. The following points must be entered to enable the external guide: 1) Hardware.ini: [LCI] UseExtGauge=1 [LCIGauge] Dll=OEMLCIextGaugePipe.dll ConnectionName=LCIGauge ExtGaugeProgram=LCIClient.exe 2) The Innocor program folder shall contain the file LciClient.exe. Another option is to display the breathing guide on another computer via a local network. However, the breathing guide can not be turned on/off from the Innocor program. The following points must then be entered to enable the external guide: 1) Hardware.ini: [LCI] UseExtGauge=0 [LCIGauge] Dll=OEMLCIextGaugeSocket.dll Server=x.x.x.x Port=23 Where x.x.x.x is the IP address of the external computer 2) The program LCIRemoteGauge.exe must be started on the external computer before the LCI test is started. 1.1.6.2 Video player on external screen The software supports now a list of various videos. All videos in a folder will be listed when starting a video. The video folder is defined in LCI.ini. Example: [Movie] name=C:InnocorVideoDefault_Movie.avi player=C:Program FilesWindows media playerwmPlayer.exe extensions=avi;mp4;mov In the above example the movie folder is defined as C:InnocorVideo and the Default_Movie.avi is the default selection. The software will look for files with one of the extensions defined in October 2018

SRI-029, Rev. 01

6

Innovision

Innocor® Software Release Information – for version 8.10

“extensions=”. “Player=” defines the program to use to show the movie, and if not defined the default player associated to the extension will be used. Note: the Innocor software can only control video on the local computer, not on an external computer.

1.2

PATIENT DATA

Requirements to entering of patient data can be configured. The option is defined in Hardware.ini: [Patient] Anonymous=1 0: All patient fields must be entered 1: As “0”, but patient name is not required (default) 2: Patient name cannot be entered and is not shown. The date of birth can only be entered as year, and is by the software interpreted as 1st of January that year.

1.3

MINOR MODIFICATIONS

1.3.1 Start of Test The start of a Breath-by-Breath or Mixing Bag test is as default automatically initiated after the warm-up period. Version 8.10 gives the opportunity to let the operator press a Start button after the warmup period, and thereby initiate the start of the test. The option is defined in Hardware.ini: [BBB] ManualWarmupStart=0 0: Auto start after warmup (default) 1: Operator start after warmup 1.3.2 Minimum file length The required numbers of data points to save a Breath-by-Breath or Mixing Bag test is changed from 10 samples to 2 minutes. 1.3.3 Mixing bag If no breaths are found within an interval of 18 s the breath detection is ignored in the calculation. I.e. Ve, Vo2 and Vco2 are set to 0, and only Fco2-ET and Fco2-ET are calculated 1.3.4 New folder with exercise drivers New folder for configurable devices are created: C:InnocorDevices. The folder contains drivers (*.dll) for • exercise devices (Ergonline, Lode, etc.) • heart rate devices (Nonin, Innologger, etc.) • SpO2 sensors (Nonin) • NIBP device (SunTech, Ergoline, etc.) The relevant drivers are automatically moved from C:InnocorProgram during installation. Windows 10 scans these files prior to loading, and in order to have a faster response time going into Measurement the first, it has been needed to move these files to a separate folder. 1.3.5 Bug correction - Error (rare) corrected with respect to bag filling for rebreathing during exercise.

October 2018

SRI-029, Rev. 01

7

Innovision

Innocor® Software Release Information – for version 8.01

2

UPDATE TO VERSION 8.01

2.1

MINOR MODIFICATIONS

-

Support for starting different video players from LCI. The video player and video are defined in LCI.ini. Example: [Movie] name= J:Innocor Rebreathing Animation.mov player= C:ProgrammerQuickTimeQuickTimePlayer.exe

-

Colour and target value for LCI guide bar changed.

-

Error corrected with respect to recalculation of VE/Vco2 and VE/Vo2 in the exercise report after moving the Min, AT, RC and Max lines.

-

Error corrected with respect to detecting the stand alone flowmeter on Innocor model 10.

-

Error corrected with respect to updating after recalculation of mixing bag results.

October 2018

SRI-029, Rev. 01

1

Innovision

Innocor® Software Release Information – for version 8.00

3

UPDATE TO VERSION 8.00

3.1

RUNNING INNOCOR SOFTWARE ON AN EXTERNAL PC

3.1.1 Introduction Newer Innocor’s will be running from an external standard Windows computer. Using a standard external computer means significant advantages in flexibility in choice of supplier, and integration to other systems including Electronic Record System. Note: Older Innocor’s with an integrated computer system cannot be controlled from an external computer – it requires some hardware changes to by-pass the internal computer. 3.1.2 Adapt display size When running on an external computer with a larger display than the standard 800x600, the Innocor software can either be full screen or reduced. All graphs and input boxes are scaled to the actual screen resolution whereas the size of buttons (in pixels) is maintained. The display size is by default set to full screen, but can be controlled by height and width parameters defined in the setup file Hardware.ini. Example: [Screen] Width = 800 Height = 600 Left=0 Top=0 The position of the Innocor display can be changed by dragging the Innocor main page. Once the main page is placed all other menus are placed according to this position.

October 2018

SRI-029, Rev. 01

1

Innovision 3.2

Innocor® Software Release Information – for version 8.00

EXPORT / IMPORT OF INDIVIDUAL TEST’S

3.2.1 Introduction A new functionality in version 8.00 is the support for exchange and share of tests between Innocor’s. Individual tests can be exported and imported into another database. The export can be done anonymously, so external partners can evaluate the data without violating personal data privacy. Individual tests can be selected in the Data Management and exported to individual files. The export consists of two files, one file with all elements from the original databases and one optional file with the raw data. Both files are placed in the general export folder, which as default is C:InnocorExport, but often changed to the USB memory key. The export files can either include all personal data or none (anonymously) in which case personal data are removed from the files. The export files can be moved and imported into another Innocor or send to an external partner for evaluation. Export / Import of individual tests is started from the Data Export Menu

October 2018

SRI-029, Rev. 01

2

Innovision

Innocor® Software Release Information – for version 8.00

3.2.2 Export of tests By default tests are exported with raw data and all personal data, but the user has the control to switch off the raw data and/or personal data (anonymous). If anonymous, all personal data that can indentify the subject is removed from the exported files. In anonymous mode Innocor can either generate a randomized ID or the user can specify the ID.

3.2.3 Import of individual tests. Tests available for import are listed under the import menu. The type identifies the kind of test and the name is the serial number of the exporting Innocor combined by a sequential number. Ex. the shown files are exported from Innocor with serial number 345076.

Before the patient database is updated with the imported parameters it is verified whether the ID is already in use, in which case the user is notified.

October 2018

SRI-029, Rev. 01

3

Innovision

Innocor® Software Release Information – for version 8.00

By agreeing the patients to be identical all existing parameters in the patient database are overwritten by values from the import file. The system will prompt for a new ID if the patients are denied to be identical. A new subject with the specified ID is created in the patient database and the imported test is saved under this ID.

October 2018

SRI-029, Rev. 01

4

Innovision

3.3

Innocor® Software Release Information – for version 8.00

AUTOMATED FLOW-GAS DELAY DETECTION

3.3.1 Introduction A new procedure for calibrating the flow-gas delay is introduced. The new procedure requires additional hardware for a fast controlled exposure of gas to the gas sample inlet. The new procedure is at the moment only supported for the MiniValve. Both the new and the previous flowgas delay procedure are supported at the same time, and can be turned on/off by a control parameter in Hardware.ini: [BBB] DelayAuto=0 DelayMan=1 DelayAuto = 1 if new flow-gas delay procedure is installed (requires additional hardware), otherwise 0. DelayMan = 1 if old flow-gas delay procedure is supported, othervise 0. 3.3.2 Auto flow-gas menu The new flow-gas delay procedure is started the same way as the previous, but instead of using manual breaths, the gas from the gas bottle is momentarily exposed to the gas-inlet and the resultant delay measured. The delay is subtracted a fixed factory calibrated value in order to correct for the response time of the flowmeter and the difference in delay time between CO2 and SF6. The gas is exposed up to 8 times (default 3), where the first attempt is ignored due to gas flushing.

October 2018

SRI-029, Rev. 01

5

Innovision

3.4

Innocor® Software Release Information – for version 8.00

CHANGES IN THE LUNG CLEARANCE INDEX OPTION

3.4.1 LCI bar for breathing guidance An additional breathing guide is added to the LCI manoeuvre panel to help the subject maintaining a uniform breathing pattern. The bar is scaled to cover the ranges from 0 to 140% of the requested tidal volume and will show the actual volume as a green bar mowing up and down. The target is indicated as a white area with default limits of target volume ± 10%. Both the upper and lower limit can be changed by dragging the edges of the area. The volume of the last completed inspiration is indicated with a black line.

The breathing guide can be shown on a secondary screen, if available. The button “Guide on/off” is used to switch it on/off. The “Guide on/off” button is only enabled, if the Innocor program folder contains the file LciClient.exe.

October 2018

SRI-029, Rev. 01

6

Innovision

Innocor® Software Release Information – for version 8.00

Last total inspired volume Actual inspired volume

Target inspired volume

3.4.2 Start an external Video from Innocor Similar to the external breathing guide, an external video player is supported via the LCI control panel. The external video player is designed to be shown on the secondary screen, if available. Viewing movies can lower children's focus on the test situation and thereby help to achieve a more natural breathing pattern. The “Movie on/off” button is only enabled, if the Innocor program folder contains the file InnoVideo.exe, which is starting the Microsoft Video Player. The name of the movie to play is defined in the LCI.ini setup file: [Movie] name=C:Innocormovie.avi

October 2018

SRI-029, Rev. 01

7

Innocor® Software Release Information – for version 8.00

Innovision

3.4.3 Correction of VCE for equipment dead space. The ATS standard is not clear in defining the equipment dead space to correct for when calculating the VCE, which is the cumulative net (i.e. corrected for equipment dead space) volume expired (i.e. the sum of tidal volumes) during the multi-breath washout. The software supports now 2 options: 1: equipment dead space = total equipment dead space from mouth to air (default). 2: equipment dead space = equipment dead space from mouth to gas sample inlet. The option is defined in LCI.INI: [LCI] CalcATmouth=1 3.4.4 Report LCI at first breath after 2.5% point or interpolate to exact 2.5% point The ATS standard defines the “LCI point” to be the first expiration below 1/40th of the initial SF6 concentration. However a more accurate determination if found by extrapolation between the expiration before and after the 1/40th point.

N 2.5%

N+1

The software supports now 2 options: 1: The LCI point is found by extrapolation (default) 2: The LCI point is found as the first expiration below 1/40th (ATS standard)

October 2018

SRI-029, Rev. 01

8

Innovision

Innocor® Software Release Information – for version 8.00

The option is defined in LCI.INI: [LCI] Interpolation=1

3.5

DLL STRUCTURE

The Innocor program is restructured to a number of libraries, each covering a specific part of the overall system in order to lower system impact of increased functionality. To archive the full functionality the following files must be present: Innocor.exe OEMPGAdriver.dll OEMFlowCalibrate.dll OEMBbBDelay.dll OEMDelayGasCal.dll OEMSpiCollector.dll OEMSpiCalculator.dll OEMBbBCollector.dll OEMBbBCalculator.dll OEMBbBOffline.dll OEMMixBoxCollector.dll OEMMixBoxCalculator.dll InnoExtCtrl.dll InnoExtPipeCtrl.dll

3.6

The main Innocor program Library with interface to gas analyzer Library used for flow calibration Library used for online and manual flow-gas delay calculation Library used for automated flow-gas delay calculation and for level 2 gas calibration Library used for collecting spirometry data Library used for calculating spirometry results Library used for collecting BbB data Library used for online calculation of BbB results Library used for calculation of Rest, AT, RC and Max points in a stress test Library used for collecting mixing bag data Library used for online calculation of mixing bag results Library used for external control of Innocor over a serial line Library used for external control of Innocor over a named pipe

MIXING BAG METHOD

The Innocor software supports an alternative calculation of VO2 and VCO2 via a dynamic 15 litre mixing bag method. The calculation is slower than Breath-by-Breath, but more precise. The method has been used in the old equipment AMIS 2001, but is not CE or FDA approved. Contact Innovision ApS for further information.

3.7

MINOR UPDATES

3.7.1 External control via a named pipe The external control of Innocor is extended to include control over a named pipe. The previous serial interface is still available and placed in library “InnoExtCtrl.dll”, whereas the new name pipe interface is placed in “InnoExtPipeCtrl.dll”. The two control interfaces uses the same commands and are thereby transparent. Innocor will try to locate and install the pipe library during start up. If the library is not found Innocor will try to locate and use the library with the serial interface. 3.7.2 Search for serial connections Instead of using fixed serial ports for the internal units (PGA, O2 analyzer, HR/SPO2 analyzer and blood pressure) all available serial ports are searched for the specific units.

October 2018

SRI-029, Rev. 01

9

Innovision

Innocor® Software Release Information – for version 7.10

4

UPDATE TO VERSION 7.10

4.1

INNOCOR CONFIGURATIONS

4.1.1

Introduction

The new major functionality in version 7.10 is the support of having more than one Innocor configuration. So far it has been required to go to setup and change all settings manually or use the script facility. Now the user only has to pick an Innocor configuration from a list when entering measurements and all settings are automatically loaded before start. The necessary calibrations can also be done when selecting the configuration without going to Setup.

Measurement Calibrate

Select configuration

New

Select patient

Display results

Test

Save results

An Innocor configuration contains: • Hardware configuration (e.g. flowmeter type, dead spaces, exercise device etc.) • Functionality (i.e. what types of measurements shall be available: rebreathing, Breath-byBreath, spirometry, LCI) • Graphical setup (setup of plots, symbols and colours) • Table setup • Printer setup Examples of how the Innocor configurations can be used: • To switch between the standard Innocor respiratory valve unit and a setup using a stand-alone flowmeter from Hans Rudolph. o The Innocor configuration defines the flowmeter table and dead spaces for the 2 setups. • To switch between a setup for exercise testing and measurement of resting Vo2 in CathLab’s. o The Innocor configuration defines the graphical and numerical setup for each case, and defines calculation parameters/limits for the Breath-by-Breath. Further the exercise testing contains both rebreathing and protocol control, where the resting Vo2 in CathLab’s is limited to Breath-by-Breath. • To switch between print layout from one department to another. o The Innocor configuration defines the layout of the printed reports, including different

October 2018

SRI-029, Rev. 01

1

Innovision

Innocor® Software Release Information – for version 7.10 headers. One department maybe wants the printing on paper, where the other wants it to be saved as PDF on a server. Available functionality of configuration

Calibration status

List of configurations

Explanatory text for each configuration

Menu for selecting an Innocor configuration. The Prepare button brings up the menu below, where both the status of the calibrations are given as well as direct access to the calibrations.

October 2018

SRI-029, Rev. 01

2