SpiroSensePro Software Instructions for Use Feb 2018

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Instructions for use Information as of: November 2017. All rights reserved. Technical and design changes and printing errors reserved. Principle shown in illustrations.

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IMPORTANT INFORMATION ...

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General... Information about the instructions for use ... Structure of safety instructions ... Trademark references ...

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PRODUCT DESCRIPTION...

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Product variants... Description of function ... Reference values... Comparing values using the Z-score...

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DESCRIPTION OF THE SOFTWARE...

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Glossary ... System requirements... Installing and uninstalling the software... Starting the software... Start window ... Overview of functions ...

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APPLICATION...

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Basic Settings... Managing patients ... Configuring the patient device ... Performing a spirometry test ... Importing measurements from a patient device ... Overview of measurements, spirometry tests and bronchodilation tests ... Viewing / comparing spirometry tests... Quality criteria... Bronchodilation test ... Detail view of imported measurements ... Analysing progress (Diary) ... Animation...

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SUPPORT FUNCTIONS...

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Remote maintenance ... Send system fault ...

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CONNECTING TO A PRACTICE MANAGEMENT SYSTEM (GDT INTERFACE) ...

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Configuration of the software... Configuring the PMS ... Dataflow with GDT interface activated ...

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MAINTENANCE ...

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Data backup ... Calibration report ... Bioverification ...

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MISCELLANEOUS...

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IMPORTANT INFORMATION

1.1

General Please read these instructions for use and all other instructions belonging to the product thoroughly. Do not discard, so you can consult them at a later date. If you fail to comply with the instructions for use, injury or damage to the device cannot be ruled out.

1.2

Information about the instructions for use These instructions for use are intended for use by doctors and professional medical staff. They apply to the "SpiroSensePro" and "mySpiroSense Pro" product packages with the SpiroSensePro software version 2.0. The instructions for use provide comprehensive information about the SpiroSensePro software and its use with a doctor's device (SpiroSensePro) or a patient's device (mySpiroSense). Symbols used: – List item • Description of an action Æ Result of a sequence of actions Software functions described in these instructions for use which are only available for the SpiroSensePro are identified with an icon on a purple background:

Specific instructions for use are available for the devices. They include descriptions of the respective functions, operation and cleaning of the SpiroSense among other information. These instructions for use are included in each product package and must be read and followed as well. If a mySpiroSense device is issued to a patient for taking measurements at home, the instructions for use of the SpiroSense must be given to the patient as well. If these instructions for use are lost, you can request another copy from PARI GmbH. The patient data examples shown are entirely fictitious. Any similarity to real personal cases is purely coincidental.

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1.3

Structure of safety instructions Safety-critical warnings are categorised according to hazard levels in these instructions for use: – The signal word WARNING is used to indicate hazards which, without precautionary measures, can result in serious injury or even death. – The signal word CAUTION is used to indicate hazards which, without precautionary measures, can result in minor to moderate injury or impair treatment. – The signal word NOTICE is used to indicate general precautionary measures which are to be observed to avoid damaging the product during use.

1.4

Trademark references The following brand name is used in these instructions for use: Windows® is a registered trademark or trademark of the Microsoft Corporation in the USA and/or other countries.

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PRODUCT DESCRIPTION

2.1

Product variants There are two SpiroSense product packages available for professional use: – SpiroSensePro: Doctor's device with SpiroSensePro software The SpiroSensePro can be used to carry out spirometry measurements in the surgery. The software offers an extensive range of analysis functions for the measurement data collected. – mySpiroSense Pro: Patient's device (mySpiroSense) with SpiroSensePro software The software enables measurement data that was recorded by the patient at home using the mySpiroSense to be read in and displayed.

2.2

Description of function SpiroSensePro With the SpiroSensePro, it is possible to capture spirometric data in real-time measurements and to display them graphically. The SpiroSensePro software offers a wide range of supporting functions. It automatically identifies the breathing cycles with the best performance and prepares these for rapid analysis. The software also supports the evaluation of bronchodilation tests, because the spirometry tests before and after medication administration can be compared to each other directly. The cartoon animation of the software assists and motivates patients to perform the breathing manoeuvre properly, so that its results are meaningful. mySpiroSense Pro Measurement data collected and saved by the patient at home using the mySpiroSense can be imported by the SpiroSensePro software via the USB interface and displayed as a graphical representation. This is helpful for both diagnosis and treatment and makes it easier to monitor progress.

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2.3

Reference values With the graphical display of reference values with the SpiroSensePro software, the measured lung function can be compared rapidly with the reference values of healthy subjects with similar anthropometric characteristics such as sex, age, height and ethnicity. It is therefore important to ensure that the age, weight and sex of each patient has been entered in the software database correctly. [see: Creating a new patient, page 19] [see: Changing patient data / Deleting a patient record, page 20] The interpretation of the results of the values measured with the SpiroSensePro relies on a comparison with reference values according to Quanjer et al. 20121.

2.4

Comparing values using the Z-score The values measured for your patient with the SpiroSensePro can either be compared as a percentage of the reference value (%Ref) or using the Zscore2. The percentage comparison method is used very widely, but it does not take into account the variance of the normal values. A comparison using the Z-score is better and is recommended by GLI (Global Lung Function Initiative) and "Deutsche Atemwegsliga" (German Respiratory Health League). The Z-score describes the deviation from the reference value in multiples of the standard deviation. Thus, a Z-score of "0" would mean that the reference value was reached exactly. A Z-score of "-1" means that the value reached has a standard deviation lower than the reference value. A certain percentile can always be assigned to a Z-score. Accordingly, the 5th percentile, which is defined as the lower limit of the normal range (LLN = lower limit of normal) corresponds to a Z-score of "-1.645". Values above this threshold fall within the normal range (white). Values below this threshold are shown in red.

1) Exceptions are the Peak Flow (PEF), FEF25 and FEF50. These values are not considered in Quanjer et al. 2012. Therefore, depending on the age of the patient the values are calculated from the EGKS reference value study, which was revised in 1993, or the 1987 and 2003 reference value study by Zapletal. 2) The standard deviation of the measured lung function from the predicted value (= "pred.").

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DESCRIPTION OF THE SOFTWARE

3.1

Glossary The following terms are used in the description of the SpiroSensePro software, and they have the following meanings:

3.2

Breathing cycle

A breathing cycle consists of one inhaling and one exhaling process.

Measurement

A measurement carried out with a mySpiroSense. The measurement encompasses one breathing cycle.

Manoeuvre

Measurement carried out with a SpiroSensePro, possibly including several breathing cycles. A manoeuvre begins when the button is clicked and ends when the button is clicked.

Spirometry test

A manoeuvre which is carried out using a SpiroSensePro and stored in the software. A spirometry test can include up to three manoeuvres.

System requirements The computer on which the software is to be installed must at least satisfy the following requirements:

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Operating system:

Windows 7 or higher

CPU:

Core2duo (first released in 2009) or higher

Available hard disk space:

at least 500 MB

RAM

at least 2 GB

Installing and uninstalling the software Installing To install the SpiroSensePro software, proceed as follows: • Insert the USB stick with the SpiroSensePro software in a free USB port on the computer. • Open the content of the USB stick and start the "SpiroSensePro_X.X.X.exe" installation program. • Read and accept the licence terms. • Follow the instructions of the installation wizard. Æ Upon successful installation, a link to the software ("SpiroSensePro") will be placed on your computer desktop. • Start the software. • If necessary, enable the connection to the software database by confirming an automatic message from the firewall. Æ The software is ready for use. Æ A link to the software has been placed on the desktop of the computer.

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Uninstalling To remove the software from your computer, proceed as follows: • Go to the Control Panel for the operating system and open the area "Programs and Functions" or "Programs and Features". • Select the entry "SpiroSensePro" and click on "Uninstall". • Follow the instructions of the uninstaller program. Æ The software has been removed from your computer.

3.4

Starting the software • Click on the link to the software on your desktop (SpiroSensePro). Æ The software will start.

3.5

Start window The initial screen appears upon opening the software:

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2 3 (1) Function bar This area contains the buttons that allow you to select the main functions (on the left) and their subordinate functions (on the right). [see: Description of function, page 7] (2) Display area The data associated with the currently selected function is displayed in this area. (3) Status line Display of information about the connected device.

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3.6

Overview of functions The functions listed in the following table can be opened from the function bar. Functions that are only available for a SpiroSensePro are identified by an icon on a purple background. – Overview, selection and detailed display of created patient records – Change patient data – Delete patient records [see: Changing patient data / Deleting a patient record, page 20] Create a new patient record. [see: Creating a new patient, page 19] Only available if the GDT interface has been activated in Settings.

Request for patient data from an associated practice management system and measurement enquiry for a new patient. [see: Requesting patient data and measurement enquiry from PMS, page 46] Only active if a patient for whom data has been saved is selected.

Graphical overview of stored measurements, spirometry tests and bronchodilation tests already carried out for the selected patient. [see: Overview of measurements, spirometry tests and bronchodilation tests, page 30] Link two spirometry tests to a bronchodilation test. [see: Bronchodilation test, page 35] / View or compare detailed measurement values from spirometry tests (measurements taken with a SpiroSensePro device). [see: Displaying spirometry tests, page 31] Generate Spirometry or Broncholysis report as a PDF file from the manoeuvres shown. [see: Creating a PDF file of spirometry and bronchodilation results, page 34] Enlarge or shrink the display in three zoom increments. The currently selected display size is shown as a number.

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– Graphical display of the trend of previous measurement values that were recorded by the patient using a mySpiroSense. – Display of FEV1, FVC, PEF, FEV1/FVC, FEV0.5, FEV0.75, FEF25-75, FEF50 and FEF75 – Display of numeric measurement values – Display of stored comments [see: Analysing progress (Diary), page 38] Generate diary report as PDF file. [see: Creating a detailed diary report, page 39] Enlarge or shrink the display in three zoom increments. The currently selected display size is shown as a number.

– 13 – Only active if a SpiroSensePro is connected to the computer.

– Carry out real-time measurements (spirometry tests) – Graphical monitoring of the trend of lung function measurements – Automatic selection of measurement intervals – Display of F/V, F/t and V/t curves at selected intervals – Display of numeric measurement values at selected intervals – Graphical representation of reference values (lln. / pred.) – Numeric representation of absolute and relative reference values – Comment function (Save doctor's comment) [see: Performing a spirometry test, page 25] / Start and stop a manoeuvre. Save data from the spirometry test just taken. Generate spirometry test result as PDF file. [see: Creating a PDF file of spirometry and bronchodilation results, page 34] Only available if the GDT interface has been activated in Settings and the detail view of a spirometry test is open.

Transmission of the spirometry test and optionally the reports generated (PDF files) to the practice management system. [see: Transmitting a spirometry test to the PMS, page 47] Animation for children. [see: Animation, page 40] Difficulty level Set the difficulty level for the animation. [see: Adjusting the difficulty level, page 41] Start the animation. Stop the animation. Enlarge or shrink the display in three zoom increments. The currently selected display size is shown as a number.

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Basic configuration of the software: [see: Basic Settings, page 15] – Select language for the user interface – Select measurement system – Select a unit for flow values (L/min or L/s) – Select a unit for PEF (L/min or L/s) – Activate game in separate window – Activate/deactivate bioverification [see: General Settings, page 15] Select measurement parameters for display [see: Parameters, page 16] Store practice information. This data is also output when reports are printed. [see: Print report, page 17] Configure the GDT interface [see: CONNECTING TO A PRACTICE MANAGEMENT SYSTEM (GDT INTERFACE), page 45] – Information about the software – Information about the open source software used – Option to start a remote maintenance session [see: About, page 19]

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APPLICATION

4.1

Basic Settings To carry out basic configuration of the software select the Settings function in the function bar.

General Settings

Select the language for the user interface. Select the measurement system for height and weight information: or Select the unit for displaying flow values: L/min or L/s Select the unit for displaying values for the "PEF" lung function parameter: L/min or L/s The cartoon animation for children can be opened in a separate window. [see: Animation, page 40] Activating bioverification [see: Bioverification, page 48]

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Parameters The lung function parameters to be displayed in the measurement value table in the detail view of spirometry tests are selected on this tab.

Lung function parameters which can be displayed in the measurement value tables but have not been selected. Lung function parameters which will be displayed in the measurement value tables. The order in which the parameters are shown in this list determines the order in which the parameters are displayed in the measurement value tables.

To select the displayed lung function parameters and define the order, proceed as follows: To add a parameter: • Click on the desired parameter in the "" list and drag it to the desired position in the "" column. a Values for this parameter will be displayed in the corresponding position in the measurement value tables. To remove a parameter: • Click on the desired parameter in the "" list and drag it out of the column. a The parameter is listed in the "" column again. a Values for this parameter are no longer displayed in the measurement value tables.

– 17 – To change the order of the selected parameters: • Click on the desired parameter in the "" list and drag it to the desired position. a Values for this parameter will be displayed in the corresponding position in the measurement value tables. • your settings or cancel your input by clicking on . The values obtained are only displayed for the selected parameters in the measurement value tables. But the values for all parameters are saved for each manoeuvre.

Print report Information about the practice can be stored on this tab. This information is output in the header when spirometry test results are printed.

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GDT Interface All the information needed for exchanging data with a practice management system is stored on this tab. [see: CONNECTING TO A PRACTICE MANAGEMENT SYSTEM (GDT INTERFACE), page 45]

Checkbox for activating and deactivating the GDT interface Storage location for spirometry tests which are to be transmitted to a PMS Option for transmitting results reports (PDF Report) Storage location for PDF reports which are to be transmitted to a PMS Four-character GDT identifiers for the PMS GDT identifier for the SpiroSensePro software. Any identifier consisting of four characters can be defined.

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About This tab contains information about the software. Support for a remote maintenance session can also be started from here.

Version of the installed SpiroSensePro software A PDF is opened with licence information for open source software that was used for the SpiroSensePro. A program that enables remote maintenance is started. [see: Remote maintenance, page 44]

4.2

Managing patients Patient data are managed with the function. This function is activated automatically when the program is started. All the patients already contained in the database are listed in the display area. If a mySpiroSense that has been assigned to a specific patient is connected, this patient is selected automatically. The name and additional data associated with the selected patient is shown in the function bar.

Creating a new patient • Click on the button. a The patient data area is displayed. • Fill out at least all of the mandatory fields (indicated with a red border). The information in the mandatory fields is essential for assigning the reference values correctly. • Click on . Æ A new patient record is created.

– 20 – Ethnicity is organised in the following groups: Ethnicity

Countries Europe, Israel, Australia, USA, Canada, Mexico, Brazil, Chile, Uruguay, Venezuela, Algeria, Tunisia Africa Korea, China north of the Huai river and the Qinling mountains Thailand, Taiwan, China south of the Huai river and the Qinling mountains (including Hong Kong) All other countries or mixed ethnicity

Changing the list format and sort order The patient list can be sorted in ascending or descending order by clicking on the respective column name (e.g., Surname). The order of the columns can also be rearranged at will by dragging the column to the desired position with the mouse.

Changing patient data / Deleting a patient record To ensure that the evaluations of the measurements and spirometry tests are correct, the information for patients' weight and height should be verified and corrected if necessary at every visit. The associated patient data is shown by double-clicking on a patient's name:

The data can be changed or supplemented. The number of the device assigned to the patient is also shown. If data that is important for the calculations is changed (weight or height), the values calculated earlier remain unchanged in the patient history! The patient record can also be deleted from the database together with all saved data.

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Searching for patients The software has a full text search function for finding patients rapidly. A search can be carried out using the first name, surname, patient number and date of birth. To search for a specific patient, proceed as follows: • Click in the text box beside the magnifier. • Enter a search string. You can also search for word fragments. a The search begins as soon as you type in the search box. The search results are narrowed down with each new character entered. Æ The search for the string (text or value) entered in the search box is carried out in all patient data. Æ All patients whose data contains the search string are listed. To reset the filter and again display all patients contained in the database, click on the Delete cross on the right border of the search box.

4.3

Configuring the patient device Patients can be given the equipment for taking measurements at home with a mySpiroSense. The measurements carried out with this device can be imported for evaluation via the USB interface at the next visit to the doctor's surgery. For this, every mySpiroSense must first be assigned to a specified patient.

Assigning the device To assign a device to a patient, proceed as follows: • Retrieve a patient record or create a new patient record. • Connect a mySpiroSense to the PC on which the SpiroSensePro software is installed. a The software will recognise the device and display it in the status line. Info: If the device has already been assigned to another patient, the patient's name will be displayed in the status line. You then have the option to change the assignment (with the options of deleting or retaining the measurements already stored on the device) or cancelling the operation. • Assign the device to the patient you have retrieved by clicking on the button. Æ The device is then permanently assigned to this patient with a unique number. All measurements carried out with this device will be imported into the database and saved with the patient as soon as the device is connected to the PC via the USB cable. If you have assigned a device to the wrong patient by mistake, you can delete the device assignment again [see: Deleting a device assignment, page 24].