Quality makes the Difference SOFTWARE MANUAL. from version

Quality makes the Difference SOFTWARE MANUAL from version 1.1.17

Table of Contents Table of contents Important Notices...6 First Steps...7 System Requirements...7 Installing Software...9 Connecting the Device with the Computer...10 Starting TRENDset...11 Elements of the User Interface...12 Menu Bar...13 Symbol Bar...13 Status Bar...14 Function Bar...15 Working with Files...16 Opening Files...16 Close File...16 Save Data...17 Quit TRENDset...17 Print...18 Pre-Settings...19 Setting the Language for TRENDset...19 Registration and Deregistration for Service Personnel...19 Setting Event Limits for Statistics...20 2

Table of Contents Communication with the Device...21 Search the Device Automatically...21 Search Device Manually...22 Troubleshooting...23 Read Device Data...24 Delete Device Data...26 Using an SD card...28 Using an SD card in a respiratory therapy device...28 Use of the DATA box...30 Read SD card...31 Format SD card...32 Save Data from SD cards...33 Open Data from SD cards...33 Information about TRENDset...34 Using Help...34 Patient Data...35 Entering, Changing and Managing Patient Data...36 Display current Therapeutic Pressure...37 Display Device Characteristics...38 Device Settings...39 Set Therapeutic Pressure...40 Set Respiration Parameters...43 Set Softstart Ramp and Mask Test...45 3

Table of Contents Set Alarm parameter...48 Setting Device Parameters...51 Working with the Parameter-Popup...55 Therapy Calendar...56 Therapy Memory...57 Compliance Memory...57 Efficiency Data Memory...57 Therapy Calendar Areas...59 Select Therapy Days for Statistics...60 Open Protocol on Duration of Therapy...61 Data and Events...62 Analysis of Data and Events...63 Select Therapy Days...66 Zoom View...66 Enlarge and Reduce Diagrams...67 Monitor Course of Therapy in Real Time...68 Alerts and Parameter Changes...70 Display of the Events...71 Using the Filter Options...71 Statistics...72 Select Therapy Days...73 Analyze Distribution of Pressure Over Time...75 Analyze Frequency of Events...76 4

Table of Contents Effect of the Therapeutic Pressure...77 Chronological Distribution of Events...78 Statistical Analysis...79 Times and Counters...80 Run Times of the Device or Components...81 Reset Filter Age...82 Set Date...83 Set Time...84 De-Activate Alarm Clock Function...85 Set Alarm Time...86 System Messages...87 5

Important Notices Important Notices TRENDset is the analysis software for respiratory therapy decvises produced by the company HOFFRICHTER GmbH. Its main functions are the analysis of therapeutic data and remote adjustment of the device parameters. This software is used in the sleep laboratory by medical personal and by the service. WARNING Before you use TRENDset: 1. Read the User s Manual for the device. 2. Read the Software Manual for TRENDset. NOTE: We recommend that you always use the current version of TRENDset. Keep up to date at www.hoffrichter.de. 6

First Steps First Steps System Requirements Hardware Requirements AMD Athlon/Pentium Class (x86), Operating Frequency 700 MHz min. 192 MB RAM for MS Windows 98, NT4.0, ME min. 400 MB RAM for MS Windows 2000, XP, Server 2003, Vista min. 150 MB free hard disc space (depending on the desired storage volume for patient data) min. 280 MB free hard disc space for the Microsoft.NET Framework 2.0 Redistributable (x86) 2 MB Graphics card with at least High Color (16 Bit) Mouse One available COM-interface for each device One available SD-interface (only when using the DATA box) 7

First Steps Software Requirements Operating system: MS-Windows 98 MS-Windows NT 4.0, Service Pack 6a MS-Windows ME MS-Windows 2000 MS-Windows XP MS-Windows Server 2003 MS-Windows Vista Installation of the newest Service Packs and critical updates for the operating system used Windows Installer 3.0 (Windows 2000/NT and lower) Microsoft.NET 2.0 Frameworks Microsoft Internet Explorer 5.01 or later versions Other requirements a serial cable (connectors: 9pin D-Sub plug and RJ11 plug) 8

First Steps Installing Software There are two options for installing TRENDset: 1. Installation from CD 2. Download from the HOFFRICHTER-Homepage www.hoffrichter.de NOTE: TRENDset can only be installed with administrator rights. Installating from CD Insert the CD in your computer s optical drive. The Setup will start up automatically if the Autorun-Function is active. Follow the installation instructions. If the.net-framework is not installed on your computer, you will be asked to install the.net-framework. Follow the installation instructions. Installing the Download Version Execute the TRENDset.zip.exe and unpack the files. The installation will start automatically. If the.net-framework is not installed on your computer, you will be asked to install the.net-framework. Follow the installation instructions. 9

First Steps Connecting the Device with the Computer 1. Connect the 9pin D-Sub plug 1 of the serial cable to the COM interface of your computer. 2. Connect the RJ11 plug (2) to the device. 3. Connect the device to a grounded contact outlet using the delivered power cord. 1 2 1 The cable can be ordered from HOFFRICHTER under Article-No. 00005232. 10

First Steps Starting TRENDset 1. When you start TRENDset, the Intro Window appears. 2. TRENDset searches automatically for connected devices. Intro Window with TRENDset version number All founded devices are listed. Select the desired device by mouse click. Afterwards starts the data import. This process will take at most 50 seconds. TRENDset changes to the status Online (see page 14). If no device has been detected under Found devices no devices will be displayed and TRENDset remains in the status Offline (see page 14). All programming and analysis functions remain deactivated. You can also open an existing file. Just click on File. Furthermore you can read-in data from the SD card. Just click on Read SD card. If TRENDset is connected with a device, the status message Online appears. 11

Elements of the User Interface Elements of the User Interface Symbol bar Menu bar Status bar Function bar Workspace 12

Elements of the User Interface Menu Bar The menu bar contains all menus and menu items needed to operate TRENDset. Symbol Bar Using the symbol bar, you can call up all of the program s most important functions. Close file Open file Save file Read SD card Parameter-Popup Print data Search for device automatically 13

Elements of the User Interface Status Bar In the status bar you will find information about the connection status, the selected function area and the type of the connected device. Connection status Function area Device type 14

Elements of the User Interface Function Bar TRENDset is subdivided into 6 function areas: Patient Data Device Settings Therapy Calendar Data and Events Alerts and Parameter changes Statistics Times and Counters After the program starts, the function area for Patient Data is always opened. If you select another function area, the display in the work area will change. NOTE: The number of function areas and the display in the work area depend on the type of device. The active function area is highlighted in gray in the function bar. 15

Working with Files Working with Files Opening Files Select File > Open or in the symbol bar. The dialogue box Open will appear with the preset pathway Own Files (Documents)/ TRENDset. The folder TRENDset will be generated the first time the program is started and will be the standard folder for saving all files belonging to TRENDset. It can only open files with the extension.csw or.csa. Before a new file is opened, TRENDset first checks whether or not all open data have been saved. As soon as a file has been opened, TRENDset switches into the status Offline. If you open a file that was saved to the hard drive from an SD card, TRENDset switches to the status SD card archive. Use Ctrl+O to open a file quickly. Close File Select File > Close or in the symbol bar. Closing causes all displayed data from the connected device or file to be lost. If changes have not already been sent to the device, you will be prompted to save the changes. After closing, the status will change from Online to Offline. 16

Working with Files Save Data Save Select File > Save or in the symbol bar. The files will be saved in the folder Own Files (Documents)/TRENDset with the extension.csw. If a file is saved from an SD card, it is saved in the folder My Files (Documents)/TRENDset/THERAPY SD_Archive with the extension.csa. Use Ctrl+S to save a file quickly. Save as With command Save as you can save the open file under another name or in another directory. Quit TRENDset Select File > Exit. Before quitting, TRENDset checks whether all data have been saved. If you have not already sent your changes to the device, you will be prompted to save. 17

Print Print Select File > Print or in the symbol bar. 1. Select the printer. 2. Set the number of copies to print. 3. Mark the documents you want to print by activating the check box. You can select the number of events to be printed under Alerts and Parameter changes. Use Ctrl+P for printing a file quickly. NOTE: As long as TRENDset is open the last printer settings used are saved. 4. Confirm with OK. 18

Pre-Settings Pre-Settings Setting the Language for TRENDset Select Settings > Language. You can choose from several languages. If you need an additional language, contact our service. The selection of available languages can be expanded at any time. Registration and Deregistration for Service Personnel This menu items enables the access to the program s service area. The service area offers special actions and additional device data. The access is password-protected so that only authorized personnel have access. Registration Select Settings > Service > Log in. 1. Enter your username. 2. Enter your password. 3. If the service area should be displayed each TRENDset is started, activate the check box. 4. Confirm with OK. Deregistration Select Settings > Service > Log out. 19

Pre-Settings Setting Event Limits for Statistics Event limits establish if and after how much time the occurrence of events should be displayed and recorded in the statistics. Select Settings > Event Limits. 1. Activate an radio button. The selection options are none, 5 s and 10 s. 2. Confirm with OK. For these types of devices you can set the event limits. TREND II AUTO/CPAP VECTOR et AUTO/CPAP VECTOR ET AUTO/CPAP (i)carat et AUTO TREND 210 AutoTREND VECTOR II FLEXLINE VECTOR II AUTO TREND II with SD cards VECTOR et with SD cards icarat et with SD cards 20

Communication with the Device Communication with the Device Search the Device Automatically Select Communication > Automatic Device Search or in the symbol bar. All founded devices are listed. Select the desired device by mouse click. Afterwards starts the data import. This process will take at most 50 seconds. TRENDset changes to the status Online (see page 14). If no device has been detected under Found devices, no devices will be displayed. TRENDset remains in the status Offline (see page 14). All programming and analysis functions remain deactivated. If TRENDset is connected with a device, the status message Online appears. 21

Communication with the Device Search Device Manually If multiple devices have been connected to your computer, apart of the automatic device search function, you may have access to a particular system by manual selecting of the respective COM-PORT. Select Communication > Manual Device Search. 1. Select the COM-Port to which the device is connected. 2. TRENDset searches for a connected device. a. When a device is detected, the data import starts. This process will take at most 50 seconds. b. If no device is detected, the message No Connection to Therapy Device appears. Confirm this with OK. Select another COM-Port and confirm again with OK. Repeat this procedure until TRENDset has found the device. 3. TRENDset changes to the status Online (see page 14). If no device is detected, TRENDset remains in the status Offline (see page 14). All programming and analysis functions remain deactivated. If TRENDset is connected with a device, the status message Online appears. 22

Communication with the Device Troubleshooting While TRENDset searches for a device, the following system messages can appear: System message No Connection to Therapy Device. The COM Port x is invalid or is used by another application. No connection to therapy device at the COM Port x. Cause A wrong COM-Port was selected. The COM-Port is either unavailable or blocked by another application. The device is not turned on. The serial cable is not properly connected with the computer or the device. The device is connected with another COM-Port. No device is connected. 23

Communication with the Device Read Device Data Select Communication > Read Device Data. You will have the option of three sub-menus: Read Device Memory Read Device Parameters Read Patient Data (if supported) Read Device Memory Select Communication > Read Device Data > Read Device Memory. The device memory consists, depending on device type, of a therapy memory and a compliance memory. The therapy memory contains all therapy data. In the compliance memory, only data on the use of the device are saved. You find the therapy data in the function areas Therapy Calendar, Data and Events as well as their statistical evaluation are found in Statistics. The use of the device will displayed in the Therapy Calendar. In these function areas you will find the imported therapy data. 24

Communication with the Device Reading the Device Parameters Select Communication > Read Device Data > Read Device Paramaters. The device parameters are displayed in the function areas Patient Data, Device Settings as well as Times and Counters. In these function areas you will find the imported device parameters. Reading Patient Data Select Communication > Read Device Data > Read Patient data. Patient data are imported and displayed in the function area Patient data. In this function area you will find the imported patient data. 25

Communication with the Device Delete Device Data Select Communication > Delete Device Data. You will have the option of four sub-menus: Delete Patient Data Delete Device Memory and Send Factory Settings Delete Device Memory Delete Factory Settings NOTE: The menu item Delete Device Data will only be displayed when a device is recognized and TRENDset is in Online status. Delete Patient Data Select Communication > Delete Device Data > Delete Patient Data. Delete Device Memory and Send Factory Settings Select Communication > Delete Device Data > Delete Device Memory and Send Factory Settings. This function is to be used if you wish to restore the factory settings on the device and delete the device s memory. WARNING! The deletion process lasts depending on device type up to 60 sec. The device may not be disconnected from the computer or the power supply during this time. 26

Communication with the Device Delete Device Memory Select Communication > Delete Device Data > Delete Device Memory. The entire therapy memory, with all pressure and flow values and the related events, will be deleted along with the compliance memory with the data on device use. NOTE: Before each action, you will be asked if the command should actually be executed. Send Factory Settings Select Communication > Delete Device Data > Send Factory Settings. All parameters and properties of the device will be restored to their factory-standard values. Additionally, all patient data will be deleted. 27

Communication with the Device Using an SD card There are two ways to store data on an SD card. Respiratory therapy device with SD card (only in device models with SD card slot) DATA box with SD card NOTE: Before an SD card can be used for the DATA box or the respiratory therapy device, it must be formatted with TRENDset. Using an SD card in a respiratory therapy device The last 100 events are saved on the SD card. Events are changes of parameters such as therapy settings, resetting counters (e.g., filter counters) etc. The parameters are saved with the date and time they were changed, as well as the old and new value. All alarms that occurred are also saved with date and time. The following therapy-related events are also saved on the SD card: Device type Parameter CPAP AUTO BILEVEL BILEVEL ST20 BILEVEL ST30 Pressure Respiratory Flow Average System Flow (Leakage Flow) Hyperventilation Leakage Mode Frequency 28

Device type Parameter Relative Respiratory Tidal Volume Central Sleep Apnea Obstructive Sleep Apnea Mixed Sleep Apnea Hypopnea CPAP AUTO BILEVEL BILEVEL ST20 BILEVEL ST30 Apnea Airway Constriction Snoring General Artifact Adjustment Mouth Exhalation Tidal Volume Apnea alarm Low MV Communication with the Device 29

Communication with the Device Use of the DATA box The DATA box can store additional data such as oxygen partial pressure and pulse frequency. These data are shown as a curve diagram in the function area Data and Events. The data can be read from an SD card on your computer and evaluated. You will need a card reader device on your computer for this. DATA box 30

Communication with the Device Read SD card Select SD-Card > Read SD card. The dialogue box Read SD card will display the patient data that are saved on the SD card. Multiple patient data can be saved on an SD card. Activate a check box. Click on OK. The patient data are imported and displayed in TRENDset. When using a data box, TRENDset changes to the status DATA box and when using a device with an SD card to the status SD card. You can now change parameters in the function areas Device Settings or Patient Data and save on the SD card via Send. To load the files into the device, connect the DATA box to the device and then plug the SD card into the DATA box or plug the SD card in the SD card slot of the device. 31

Communication with the Device Format SD card Before an SD card can be used with a DATA box or a repiratory therapy device, it must be formatted with TRENDset. It is irrelevant whether this is a new or used SD card. Select SD-Card > Format SD card. The dialogue box Format SD card will open and will list all removable disks for your computer. Select the data storage device by activating the check box. To prevent accidental erasures of files on the other removable disks, it will check whether there are still files on the selected drive. If yes, you will be prompted to deleted these files manually. NOTE: The SD card will not be accepted by the DATA box or the respiratory therapy device unless it is formatted with TRENDset. 32

Communication with the Device Save Data from SD cards All of a patient s data can be saved on the hard drive. Read the data from the SD card (SD-Card > Read SD card). Then save the file (File > Save/Save as). Files from the SD card will be stored with the extension.csa. Unlike other TRENDset-files (*.csw) files from an SD card have the extension.csa. These file are saved in the sub-directory THERAPY SD_Archive. Open Data from SD cards Select File > Open or in the symbol bar. Before a new file is opened TRENDset checks whether all open files have been saved. As soon as a file is opened, TRENDset switches to the THERAPY SD_ Archive status. In this status you cannot store any patient data or change parameters on the SD card. NOTE: Files from the SD card (*.csa ) contain patient data. These files are often much larger than files with the extension.csw. 33

Communication with the Device Information about TRENDset Select? > About. The version number of TRENDset will be displayed along with information about the manufacturer. Using Help Select? > Help TRENDset. The Help file will open in PDF-Format. Help opens immediately if you press F1. NOTE: Help opens with Acrobat Reader. You can install the program from the TRENDset- CD if needed. 34

Patient Data Patient Data You manage patient data in the function area Patient Data, turn the therapy on and off and get information about the most important characteristics of the devices. The workspace is sub-divided into Patient Data, Display and Device Characteristics. Patient Data Device Characteristics Display 35

Patient Data Entering, Changing and Managing Patient Data All text fields highlighted in white can be written, changed and deleted. Changes will be highlighted in red. To restore all entries to their original state, click on Reset. Click on Send, in order to send changed files. Then the data are read again and displayed in TRENDset. The sent and received data are compared with each other. This assures that the correct data was written in the device. Not all devices can save patient data. If there is a connection to devices that cannot store any patient data, enter the patient data manually and confirm the entries with Accept. Save the file (File > Save/Save as). VECTOR et (i)carat et VECTOR ET TREND II point TREND 210 AutoTREND (as of device software 1.502) VECTOR II FLEXLINE VECTOR II AUTO (as of device software 1.502) These device types can save patient data. 36

Patient Data Display current Therapeutic Pressure In the Display area the current pressure is displayed along with the device status. Click on the control button On / Off and the therapy starts. Pressure Display (graphic) Turn Therapy on-/off Device Status Pressure Display (numeric) 37

Patient Data Display Device Characteristics In the area Device Characteristics you see the main features of the devices. They are purely informative and cannot be changed. 38

Device Settings Device Settings In the function area Device Settings you set the device parameters. The workspace, depending on the device connected, is subdivided into Pressure, Respiration, Softstart Ramp/Mask Test, Mask Alarm, Device and Intro Text. Pressure (numeric) Soft start Ramp/Mask Test Graphic Display of the Selected Parameters PIN code Activation Respiration Parameters Device Parameter Intro Text for the Device 39

Device Settings Set Therapeutic Pressure Select Device Settings > Pressure. You can change the therapeutic pressure in two ways: a. using the check box b. using the diagram Hold the mouse down and drag it along the red points. The drag direction is indicated by arrows. The settings in the check boxes will change automatically. You activate or deactivate the trigger using the On / Off button. The active state is shown left of the button. All changes will be highlighted in red. To restore all entries to the initial condition, click on Reset. Click on Send, to send the changed data to the device. Then the data will be read again and displayed in TRENDset. The sent and received data are compared with each other. This assures that the correct data was written in the device. 40

Device Settings Definition of Terms Therapy Pressure FLEX Level I-FLEX E-FLEX Start Pressure Min. Pressure Max. Pressure Pressure Steepness Inspiration Pressure Expiration Pressure I-Slope E-Slope Trigger I-Trigger E-Trigger Trigger Target Volume Additional Pressure Min. Inspiration Time TI min Max. Inspiration Time TI max Level of therapy pressure The level of pressure increase or decrease is depending on the flow of breath, the FLEX Levels set and the therapeutic pressure setting. The three FLEX Levels (1-3) are for individual adjustment to the patient. The value of pressure increase depends on the value of the breathing flow, the set I-FLEX and the set therapy pressure. The I-FLEX settings (0 3) are for individual adjustment to the patients breathing flow. The value of pressure decrease depends on the value of the breathing flow, the set E-FLEX and the set therapy pressure. The E-FLEX settings (0 3) are for individual adjustment to the patients breathing flow. Starting pressure Minimum pressure Maximum pressure The parameter Pressure Steepness increase determines how quickly pressure increases in an event. The speed of the pressure increase can be adjusted to the patient s sensitivity. Inspiration pressure Expiration pressure Inspiration slope Expiration slope Activating or deactivating the inspiration trigger in T-Mode Sensitivity of the inspiration trigger Sensitivity of the expiration trigger Setting the trigger sensitivity Value for the target volume (only in the S, ST and T modes) Adjustable additional pressure, with target volume activated (only in the S, ST and T modes) Minimum inspiration duration (only in the S and ST modes) Maximum inspiration duration (only in the S and ST modes) 41

Device Settings Available Parameters Depending on Therapy Mode Mode CPAP FLEX APAP BILEVEL S Therapy Pressure FLEX-Level Start Pressure Min. Pressure Max. Pressure Pressure Steepness Inspiration Pressure Expiration Pressure I-FLEX E-FLEX BILEVEL ST BILEVEL T I-Slope E-Slope Trigger (T-Mode) I-Trigger E-Trigger Trigger Target Volume Additional Pressure TI min TI max The devices have different parameters. only for VECTOR et, VECTOR ET, (i)carat et, TREND II only for VECTOR et BILEVEL ST30, icarat et BILEVEL ST30, TREND II BILEVEL ST30 only for VECTOR et BILEVEL ST20 und ST30, icarat et BILEVEL ST20 und ST30, TREND II BILEVEL ST20 and ST30 only for VECTOR et, TREND II und icarat et as of device software 2.140 42

Device Settings Set Respiration Parameters Select Device Settings > Respiration. There are two ways to change the inspiration: a. using the check box b. using the diagram Hold the mouse down and drag it along the red points. The drag direction is indicated by arrows. The settings in the check boxes will change automatically. All changes will be highlighted in red. To restore all entries to their original condition, click on Reset. Click on Send, to send the changed data to the device. Then the data will be read again and displayed in TRENDset. The sent and received data are compared with each other. This assures that the correct data was written in the device. 43

Device Settings Definition of Terms Frequency Inspiration Delay Time I:E Ratio Backup frequency Breaths per minute Duration of inspiration over entire breath Delay for switch between from S-Mode to T-Mode I:E-Ratio from frequency and duration of inspiration Frequency with which the patient continues to be ventilated when an apnea has occurred Available Parameters Depending on Device Type Mode CPAP FLEX APAP BILEVEL S BILEVEL ST BILEVEL T Frequency Inspiration Delay Time Backup frequency The devices have different parameters. 44

Device Settings Set Softstart Ramp and Mask Test Select Device Settings > Softstart Ramp/Mask Test. There are two ways to change the parameters for the Softstart Ramp and the Mask Test: a. using the check boxes b. using the diagram Hold the mouse down and drag it along the red points. The drag direction is indicated by arrows. The settings in the check boxes will change automatically. All changes will be highlighted in red. To restore all entries to their original condition, click on Reset. Click on Send, to send the changed data to the device. Then the data will be read again and displayed in TRENDset. The sent and received data are compared with each other. This assures that the correct data was written in the device. 45

Device Settings Definition of Terms Softstart Time Softstart Start Pressure Mask Test Time during which the pressure gradually increases to therapeutic pressure, beginning at the starting pressure for soft start or at minimum pressure. Starting pressure for soft start In a mask test the device is operated at maximum therapeutic pressure for the time selected in order to test the tightness of mask. The maximum therapeutic pressure results from the settings in the function area Device Settings. 46

Device Settings Available Parameter Depending on Device Type Device Softstart Time Softstart Start Pressure Mask Test VECTOR et (i)carat et VECTOR ET TREND II point TREND 200 TREND 210 AutoTREND TREND 300 TREND 400 TREND 500 TRENDlife Calypso VECTOR VECTOR II VECTOR II FLEXLINE VECTOR II AUTO VECTOR II BILEVEL The devices have different parameters. 47

Device Settings Set Alarm parameter Activate/Deactivate Mask Alarm Select Device Settings > Mask Alarm. You activate or de-activate the mask alarm using the check box. The active state is displayed left of the button. There are two ways to change the parameters for the Mask Alarm: a. using the check boxes b. using the diagram Hold the mouse down and drag it along the red points. The drag direction is indicated by arrows. The settings in the check boxes will change automatically. All changes will be highlighted in red. To restore all entries to their original condition, click on Reset. Click on Send, to send the changed data to the device. Then the data will be read again and displayed in TRENDset. The sent and received data are compared with each other. This assures that the correct data was written in the device. 48

Device Settings Definition of Terms Mask Alarm Alarm Delay 1 Pressure Difference 1 The mask alarm is activated/deactivated using the On / Off button. This value defines the delay period after which the alarm will sound. This value defines the tolerated deviation from the set pressure. 1 only when the Mask Alarm is activated 49

Device Settings Set Alarms Low MV and Apnea Select Device Settings > Alarm Low Minute Volume or Alarm Apnoa. Set the desired values using the selection fields. All changes are highlighted in red. To restore all entries to their original condition, click on Reset. Click Send to send the changed data to the device. The data is subsequently read out again and displayed in TRENDset. The sent and received data is compared. This ensures that the correct data has been saved on the device. Definition of Terms Alarm Low Minute Volume Alarm Apnea Alarm if the respiratory minute volume is too low If the respiratory minute volume falls below the value set here, the device sounds an alarm. Alarm if an apnea is detected If an apnea is detected that is longer in duration than the period of time set here, the device sounds an alarm. 50

Device Settings Setting Device Parameters Select Device Setting > Device. Use the check boxes to change the parameters. All changes will be highlighted in red. To restore all entries to their original condition, click on Reset. Click on Send, to send the changed data to the device. Then the data will be read again and displayed in TRENDset. The sent and received data are compared with each other. This assures that the correct data was written in the device. 51

Device Settings Automatic Function To set the automatic pressure adjustment, activate the check box Automatic function adjustable. This will activate the check box Automatic with the following options. OFF no automatic pressure adjustment possible Start/Stop Automatic Pressure Threshold On Automatic Pressure Threshold Off Automatic Delay adjustable Start Automatic Pressure Threshold On adjustable You can find additional information about the automatic function on page 53. 52

Device Settings Definition of Terms Mode Language Pressure Unit Brightness Display Pressure Ramp Heating Step Menu Type Device mode Device s menu language Indicates in what units the pressure should be displayed Brightness of the display Soft increase in pressure when pressure changes Selection of the heating level of the humidifier Menu, which displayed in the device Activate PIN Code When you activate the check box, you can enter a four-digit PIN Code. Once you have sent the PIN Code to the device, you can only change the device s pressure parameters and mode after entering the correct PIN Code. Automatic Automatic Threshold On The first value indicates inspiration, the second value expiration. These values must be exceeded for the therapy to start. Automatic Threshold Off The pressure must fall below this value for the therapy to stop. Automatic Delay Time after which the therapy is automatically stop when the pressure drops below the threshold value. Display Breath Status Display Efficiency Data Mask Type Intro Text Menu Scrolling Here you can define whether the display of the tidal volume is activated or deactivated during running therapy. Here you can define if the display of efficiency data, such as apnea index (AI) or the apnea-hypopnea index (AHI in CPAP and AUTO devices) and the leakage (Leak) are displayed in the info menu. Selection of the mask type in use The intro text is shown when the device starts. It can be a maximum of 2 lines of 16 characters each. You can choose from several pre-defined texts or enter your own text. Select the check box Other text. Here you can set whether scrolling is allowed in the menu or not. 53

Device Settings Available Parameters Depending on Device Type Mode Language Pressure Unit Brightness Display Pressure Ramp Heading Step Menu Type PIN Code Device VECTOR et (i)carat et VECTOR ET TREND II point TREND 200 TREND 210 AutoTREND TREND 300 TREND 400 TREND 500 TRENDlife Calypso VECTOR VECTOR II VECTOR II FLEXLINE VECTOR II AUTO VECTOR II BILEVEL as of device software 1.501 only for the respective AUTO-Devices as of device software 2.140 Automatic Automatic Pressure Threshold On Automatic Pressure Threshold Off Automatic Delay Display Breath Status Display Efficiency Data Mask Type Intro Text Menu Scrolling 54

Device Settings Working with the Parameter-Popup The Parameter-Popup is a small dialogue box which contains the essential functions from Device Settings. Select Settings > Parameter-Popup or in the symbol bar. The user interface will close and the Parameter-Popup will open. The advantage: You can use TRENDset and other applications on the screen at the same time and continue to control the device. You can only use the Parameter-Popup in the Status Online, SD-Card and DATA box. If necessary you can change the position and size of the Parameter- Popup. Hold down the mouse and drag the edges of the window. To close the Parameter-Popup and return to the usual user interface panel, click on the x on the upper right. Save space on your screen with the Parameter-Popup. After closing the Parameter- Popup, its position and size will be saved. 55

Therapy Calendar Therapy Calendar The function area Therapy Calendar includes a graphic display of device use. It shows the duration of therapy per day and in some devices the pressures used. The Therapy Calendar gets this data from the therapy memory, the compliance memory and the efficiency data memory. 1 The therapy data are evaluated in the function area Data and Events. The Therapy Calendar, shown here with display of pressures used. 1 only TREND II, VECTOR et and icarat et as of device software 2.140 56

Therapy Calendar Therapy Memory Approximately 30 days of therapy are stored in the Therapy Memory. Compliance Memory When the Therapy Memory is full, the older data are transferred to the Compliance Memory. The Compliance Memory stores data for approximately 1 year. The data from the Compliance Memory are only displayed in the Therapy Calendar and in the protocol from the Therapy Calendar. There is no display or evaluation of these data in the function area Data and Events or Statistics. Efficiency Data Memory Devices from device software 2.140 have an efficiency data memory. The following values are saved in the efficiency data memory: Apnea index (AI) or apnea-hypopnea index (AHI) increased leakage (Leak) in % average operating time (Use) The values are saved for one day, one week, one month, 6 months and one year, respectively. 57

Therapy Calendar Available Memory Depending on Device Type Device Therapy Memory Compliance Memory Efficiency Data Memory VECTOR et CPAP and AUTO VECTOR et BILEVEL and BILEVEL ST 20 and ST30 (i)carat et AUTO (i)carat et BILEVEL and BILEVEL ST 20 and ST30 VECTOR ET CPAP and AUTO VECTOR ET BILEVEL and BILEVEL ST 20 TREND II CPAP and AUTO TREND II BILEVEL and BILEVEL ST 20 and ST30 point TREND 200 TREND 210 AutoTREND TREND 300 TREND 400 TREND 500 TRENDlife Calypso VECTOR VECTOR II VECTOR II FLEXLINE VECTOR II AUTO VECTOR II BILEVEL VECTOR et, TREND II and icarat et as of device software 2.140 58

Therapy Calendar Therapy Calendar Areas Pressure, numerical in hpa Color definition of the specific pressures Day Display Leakage in % 1 Date of the therapy day Evaluation and Statistics (On/Off) Duration of therapy without indication of the pressures used Therapy duration with indication of the pressures used AI or AHI (CPAP and AUTO devices) 1 Therapy duration with indication of the pressures used When you move the mouse across a curve or bar, a Quick info is displayed in overlay. A therapy day lasts from 12:00 noon to 12:00 noon. 1 only TREND II, VECTOR et and icarat et as of device software 2.140 59

Therapy Calendar Select Therapy Days for Statistics To evaluate the therapy data in the function areas Data and Events as well as in Statistics, mark the desired therapy days. Click on the symbol to the right of the date. selected (red symbol) not selected (gray symbol) If you want to select all therapy days, activate the control box Select all displayed Days. Additionally, you can decide whether or not therapy-free days will be displayed in the Therapy Calendar. Activate the check box Display Days without Therapy in Addition. After you have marked the therapy days, you can switch to the function area Data and Events or Statistics and evaluate the data for the marked therapy days. The Complete Using Time in h and the Average Using Time per Day in h are seen in the lower part of the workspace. 60

Therapy Calendar Open Protocol on Duration of Therapy Click on Protocol. The protocol will include, along with data on the daily duration of therapy, information on the recording time, on the days used for therapy, on the total duration of use, and on the average duration of use per day. The devices VECTOR et, TREND II and icarat et, from device software 2.140, also have an efficiency data memory. To close the window, click on the x on the upper right. The protocol evaluates the Therapy, Compliance and Efficiency Data Memory. 61

Data and Events Data and Events The data can be analyzed in the function area Data and Events. Additionally, you can monitor the course of therapy in real time. The diagrams enable you to evaluate the data minute-by-minute. When you move the mouse across a curve or bar, a Quick info is displayed in overlay. 62

Data and Events Analysis of Data and Events Definition of Terms Pressure Respiratory Flow Average System Flow Relative Respiratory Volume (%) Oxygen Pulse Central Sleep Apnea Obstructive Sleep Apnea Mixed Sleep Apnea Apnea Hypopnea Airway Constriction Pressure in patient s mask Patient s flow Flow which escapes from the exhalation valve. In a leakage, i.e. if the mask slips out of face, the flow will increase. The relative volume of breath is calculated from the breath-flow. Average oxygen saturation Patient s current pulse A central sleep apnea is indicated if, in addition to a limitation of respiratory flow, little or no change in the respiratory flow is detected for the time of the set event limit, without simultaneous airway constrictions. An obstructive apnea is indicated if, in addition to a limitation of respiratory flow, little or no change in the respiratory flow is detected for the time of the set event limit, and if the airway constriction during this time is above a threshold value. A mixed apnea is indicated if the apnea consists of a central and an obstruction portion and there is no normal breathing between the two portions. An apnea is indicated if, in addition to a limitation of respiratory flow, little or no change in the respiratory flow is detected for the time of the set event limit. A hypopnea is indicated if a respiratory flow limitation lasts for the time of the set event limit. An airway constriction is indicated if the resistance of the upper airways is above a threshold value for the time of the set event limit. 63

Data and Events Snoring A snoring phase is indicated if the snoring sound is above a threshold value for the time of the set event limit. Device State Adjustment The adjustment phase includes the learning phase at the beginning of a therapy and the 30 s timeout after an increased leakage, a mode switch between APAP and CPAP as well as after a pressure change during CPAP therapy. During this period, the APAP-Algorithm is turned off. Leakage A leakage is indicated, if the middle system flow exceeds a threshold value for a maximum of 2 l/s or a shows a change of more than 300 ml/s. Mouth Exhalation Hyperventilation General Artefact CPAP Displaying an expiration by mouth Displaying a hyperventilation Displaying a general artefact Displaying an interrupted FLEX-Function Mode Display of Active Mode (APAP, CPAP, FLEX, BILEVEL S, BILEVEL ST, BILEVEL T) 64

Data and Events Displaying Data and Events Depending on Device Type Device VECTOR et/et CPAP, Trend II CPAP, TREND 210, VECTOR II FLEXLINE VECTOR et/et AUTO, TREND II AUTO, (i)carat et AUTO, AutoTREND, VECTOR II AUTO VECTOR et/et BILEVEL, BILEVEL ST20, BILEVEL ST30, TREND II BILEVEL, BILEVEL ST20, BILEVEL ST30, (i)carat et BILEVEL, BILEVEL ST20, BILEVEL ST30 Mode CPAP FLEX CPAP/AUTO FLEX all Modes CPAP Central Sleep Apnea point Obstructive Sleep Apnea Mixed Sleep Apnea Hypopnea Apnea Airway Constriction Snoring Mode, Adjustment Leakage Hyperventilation Mouth Exhalation General Artefact CPAP Pressure Respiratory Flow,,,,, Average System Flow, Relative Respiratory Volume, Qxygen Pulse Standard only when connected to a DATA box only when connected to a DATA box with Oxygen-Kit Standard for VECTOR et, TREND II and icarat et as of device software 2.140 65

Data and Events Select Therapy Days Below the diagram are the control elements for selecting the day, which you want analyze. First Therapy Day Back One Day Forward One Day Last Therapy Day Direct Day Selection Zoom View Below the diagram are the control elements for setting the zoom area 1 min to 24 h is possible. Direct Selection of Zoom Area Enlarge Zoom Area Reduce Zoom Area You enlarge the Zoom Area by double-clicking with the left mouse button; by doubleclicking on the right mouse button you reduce the Zoom Area. Zoom Area 6 h 66

Data and Events Enlarge and Reduce Diagrams For a better display you can zoom the size of the diagrams. To enlarge, click on. To reduce, click on. 67

Data and Events Monitor Course of Therapy in Real Time Click on Run Real Time Monitoring. The data will be updated every 500 ms. In contrast to the therapy data, all data are shown, including events, which are very short and otherwise are not recorded. The event limits have no influence here. NOTE: The device must be in operation for data to be displayed. To end the connection, click on Stop Real Time Monitoring. 68

Data and Events Real Time-Monitoring Depending on Device Type Device TREND II CPAP, VECTOR et/et CPAP, (i)carat et CPAP, TREND 210, VECTOR II FLEXLINE TREND II AUTO, VECTOR et/et AUTO, (i)carat et AUTO, AutoTREND, VECTOR II AUTO Mode CPAP FLEX CPAP FLEX APAP TREND II, VECTOR et/et, (i)carat et BlLEVEL, BlLEVEL ST20, BlLEVEL ST30 Pressure Respiratory Flow Average System Flow Relative Respiratory Volume Airway Constriction Snoring Mode Adjustment Leakage Hyperventilation Mouth Exhalation General Artefact CPAP Standard Standard for VECTOR et, TREND II and icarat et as of device software 2.140 all other devices 69

Alerts and Parameter changes Alerts and Parameter Changes In the function area Alerts and Parameter changes, you can view and evaluate events such as alarms, parameter changes and the deletion of times and counters which are saved on an SD card. Device settings at the time of the event Filter options Marked event (gray highlight) 70

Alerts and Parameter changes Display of the Events Type of event Time of event (date and time) Description of event Using the Filter Options The filter options enable you to filter out the events that are of interest to you. Click on the relevant checkbox to activate or deactivate it. Activated = events are displayed Deactivated = events are not displayed Date and time changed Parameter change End or start of an alarm Counter reset 71

Statistics Statistics In the function area Statistics, the therapy data are visualized with bar diagrams. This allows you to precisely analyze therapy data. The diagrams support you in titrating an effective therapeutic pressure. NOTE: In Statistics, only the pure therapy time without Mask Test or Softstart is evaluated. TREND II AUTO VECTOR et AUTO VECTOR ET AUTO (i)carat et AUTO AutoTREND VECTOR II AUTO The statistics function is available for these device types. When you move the mouse across a curve or bar, a Quick info is displayed in overlay. 72

Statistics Select Therapy Days Select all activated days in the Therapy Calendar In the selection box Therapy Day See Therapy Calendar is pre-selected. This assures that all selected days in the Therapy Calendar are included (see page 59). The sum of events is shown in the diagrams. The number of selected days can be seen under the check box. The value in brackets shows the ratio of selected days to total therapy days in percent. Selection of all therapy days that were activated for the statistics function Back One Day First Therapy Day Number of therapy days that were activated in the Therapy Calendar for the statistics function (see page 59) 60 % of all therapy days were activated in the Therapy Calendar for the statistics function 73

Statistics Select Individual Therapy Days Below the diagram are the control elements for selecting the day, which you want evaluate. You can select all days, regardless of whether they are activated in the Therapy Calendar or not. The number of selected days can be seen under the selection box. The value in brackets shows the ratio of selected days to total therapy days in percent. Last Therapy Day Forward One Day Back One Day First Therapy Day Direct Date Selection Number of therapy days selected in the selection box Number of therapy days selected using the selection box in % 74

Statistics Analyze Distribution of Pressure Over Time With the help of the Temporary Pressure Distribution diagram, you analyze the percentage distribution of pressures over the selected therapy period. On bar width stands for 0.5 hpa. When you move the mouse across a curve or bar, a Quick info is displayed in overlay. 75

Statistics Analyze Frequency of Events With the help of the Frequency of Events diagram, you analyze the number of central, obstructive and mixed apneas, hypopneas and airway constrictions depending on pressures. The snoring phases are in contrast given in minutes. One bar width stands for 0.5 hpa. The selection in the radio buttons remains in effect until the next change. When you move the mouse across a curve or bar, a Quick info is displayed in overlay. To select an event, click on one of the radio buttons. You can further specify whether the total number or the average number per hour should be displayed, and for snoring phases total minutes or minutes per hour. 76

Statistics Effect of the Therapeutic Pressure With the help of the Effect of Therapy Pressure diagram, you analyze the percentage occurrence of events depending on the therapy pressure. Snoring phases are not taken into account. One bar width stands for 0.5 hpa. When you move the mouse across a curve or bar, a Quick info is displayed in overlay. 77

Statistics Chronological Distribution of Events With the help of the Distribution of Events based on Time diagrams, you analyze the percentage occurrence of events depending on the time of day. The snoring phases are not taken into account. One bar width stands for 1 h. When you move the mouse across a curve or bar, a Quick info is displayed in overlay. 78

Statistics Statistical Analysis Click on Statistical Analysis. The overview includes along with the statistical data, data on the recording time, duration of therapy, number of days selected for the statistics and the most important device settings. As an aid to decision-making for the physician, the lower window area shows what therapeutic pressure was used 90 % of the time and at what therapeutic pressure 90 % of the events occurred. To close the window, click on the x at the upper right. 79

Times and Counters Times and Counters In the function area Times and Counters you will find information on the device s counters, set the date and time and control the alarm clock function. The workspace is sub-divided into Counter, Date and Time and Alarm Clock. Changed values that have not yet been transferred to the device are shown in red. 80

Times and Counters Run Times of the Device or Components In the Counter area, data on the device s run times or those of the device s components are saved. Filter Display (->FILTER<-) Blower Display (->SERVICE<-) Filter Age Standby Time Blower Running Time Therapy Time Interval for filter change Interval for service checkup, based on compressor run time Compressor run time since last filter change Time in which the device was on Time in which the compressor was on, incl. mask tests and soft start Time in which the compressor was on and the mask was at therapeutic pressure 81

Times and Counters Reset Filter Age In the Counter > Filter Age area, press the Delete button. The command will be sent to the device immediately and the counter will be reset to 0. 82

Times and Counters Set Date 1. In the Date selection box, mark the day, month or year and enter the desired value. OR Click on the arrow in the selection box. A calendar will open. Select the date. OR To import the date from the computer, just click on Set Computer Time. If you want to remove you settings again, click on Reset. 2. Click on Send. The date will be sent to the device. It is not possible to set the system time or to change the date on the SD card. In order to make these changes, the device must be connected. 83

Times and Counters Set Time 1. In the Time selection box, mark the hour, minutes or seconds and enter the desired value. You have the option of using the arrows to increase or decrease the marked values. OR To import the time from the computer, click on Set Computer Time. If you want to remove you settings again, click on Reset. 2. Click on Send. The time will be sent to the device. It is not possible to set the system time or to change the date on the SD card. In order to make these changes, the device must be connected. 84

Times and Counters De-Activate Alarm Clock Function The Alarm Clock Function can be de-activated on some device types. TREND II VECTOR et VECTOR ET (i)carat et Remove the check in the check box Alarm Clock function adjustable and click on Send. NOTE: If you de-activate the Alarm Clock Function, it is no longer available in the device until you re-activate it. 85

Times and Counters Set Alarm Time 1. Activate the alarm clock. 2. In the Time field, mark the hour or the minute and enter the desired value. If you wish, you can use the arrows to increase or decrease the marked value. 3. Set the snooze time in the selection box Slumber. You can select a time interval from 5 to 30 minutes. To de-activate the snooze time, select Off. If you want to remove you settings again, click on Reset. 4. Click on Send. The alarm time will be sent to the device. The snooze time (Slumber) defines the time interval which passes after turning off the alarm before the alarm sounds again. Alarm is on 86