MasterScope - Instructions for Use Identify the correct Wireless Spirometry Sensor Unit by the serial number (see label on the backside of sensor) and select it from the list. Click to start the pairing process. The bluetooth symbol indicates with dark blue that the sensor is currently connected. If the symbol is greyed out check if the sensor is turned on and connected. Page 58/233 Version 03.
MasterScope - Instructions for Use 4. Subject, Proficiency and Training Mode Choose whether you would like to work in Subject Mode, Proficiency Mode or Training Mode. 4.1 Subject Mode The data from subjects entered in Subject Mode will be used for the study and transferred to the study database. In Subject Mode you will have to follow the time periods and study phases as outlined in the study protocol when testing a subject.
MasterScope - Instructions for Use 4.4 Subject Mode Activation 1. Select Subject Mode and put your finger on the sensor twice. 2. Enter the Activation PIN for this user from the certification report. Click on . Page 60/233 Version 03.
MasterScope - Instructions for Use 3. The User can now access the Subject Mode and is allowed to perform spirometry measurements. Select the User Management tab of the Tools menu to check if the Subject Mode for each registered user is activated or not. Version 03.
MasterScope - Instructions for Use 5. Program Access System access to the MasterScope requires fingerprint identification. Your CRA and/or a representative of ERT will perform this registration at the training or during an onsite visit. The identification of the current user is necessary during start-up and before each measurement. 5.1 Fingerprint Identification To log in using the fingerprinting sensor, follow these steps: 1.
MasterScope - Instructions for Use 5.2 Temporary Password If the fingerprint identification failed, you may use the “Temporary Password” tab. This temporary password is a unique eight-digit code which can be obtained from ERT International Help Desk. A temporary password can only be used for the next 24 hours.
MasterScope - Instructions for Use 5.3 Remote Support This function enables the ERT support personnel to remotely access your system. Click . Page 64/233 Version 03.
MasterScope - Instructions for Use 6. System Overview 6.1 Main Menu The main menu guides you through the process of the clinical trial protocol and controls the access to all program functions. Status bar Utilities bar Click to select a subject to work with (also see “Search/New Subject”). In a visit workflow the screen content will change. Waiting room Current subject Workflow elements or submenus Version 03.
MasterScope - Instructions for Use 6.2 Dashboard The MasterScope offers a dashboard via the “Home” tab. Various information of the system can be found here depending on your product mix and features selected for your study. It will display e.g. Calibration, Data Transfer, Backup information or a Patient overview. More or other information might be displayed depending on the study setup. Page 66/233 Version 03.
MasterScope - Instructions for Use 6.3 Search/New Subject 6.3.1 Search Subject Click this icon and a list of all available subjects is shown, i.e. all subjects whose next visit date period contains the selected time point (e.g. today) are listed. As default, the subjects scheduled for “Today” with their “Subject Number”, “Subject Initials” (if applicable), Date and Number of their “Last Visit”, Date and Number of their “Next Visit” as well as their Sex are listed.
MasterScope - Instructions for Use In this window, the currently selected subject is shown. In addition, the currently possible visits are displayed. Click to start the selected visit of the current subject. Page 68/233 Version 03.
MasterScope - Instructions for Use 6.3.2 New Subject Click this icon for adding new subjects. Entry ranges: Subject Initials: Subject Number: Date of Birth: Age: Sex: Height: Ethnicity: Subject initials must be 1-3 characters in uppercase. 001 to 999 Day - Month - Year will be calculated automatically (40 to 120 years) Female or Male 90 to 230 cm Select appropriate ethnic group. Confirm your entries with . Version 03.
MasterScope - Instructions for Use 6.4 Waiting Room “Waiting Room” provides the possibility of switching between subjects currently performing a visit. If you have started a visit for your current subject and then select or enter a new subject, the previous one will be placed in the Waiting Room automatically. The previous “Current Subject” now appears in the “Waiting Room”. Click on a subject in the “Waiting Room” to activate this subject.
MasterScope - Instructions for Use 6.5 Utilities Some Utilities functions are only available for specific user groups. Log off: Click this icon to change the user of the system. Please use the shutdown if the system is not needed anymore. Help: Click this icon to access material such as Short Guide, local videos (if available for the study) and direct login to ERT’s online learning system (if available for the study).
MasterScope - Instructions for Use Tools: Click this icon and the following tabs can be selected: - “Administration”: administrative functions such as Printer Manager, Logging, Change Site Information, System Information, Update, System Time, Data Transfer Configuration, Confirm SD Card Transfer, Send All Data, Backup, Restore, Device Management - “User Management”: User Details can be modified, registered fingerprints can be edited, new users can be registered.
MasterScope - Instructions for Use Restore: Click this icon to restore your MasterScope in case of an unexpected data loss. The latest backup will serve as data source. Data Transfer Configuration: Click this icon to set a transfer method and make additional data transfer settings. For detailed information see chapter “Data Transfer”. Update: Click this icon to install a software update on your MasterScope. See chapter “MasterScope Software Update” on how to install a software update.
MasterScope - Instructions for Use Select your preferred system language and confirm with . There are only languages listed which are available for the particular protocol setup. If your preferred language is not available, please use English language. Screen example (with “Japanese” set as the MasterScope system language): Logging: Review of audit trail information 6.
MasterScope - Instructions for Use 7. Ambient Conditions and Calibration Check 7.1 Ambient Room Conditions At least once a day it is necessary to check the ambient room conditions. This can optionally be done by the Ambient Sensor (Automatic Ambient Condition Registration) or manually, if the system prompts the user to enter the ambient room conditions (dialog box displayed below) when attempting to perform a spirometry measurement on a subject.
MasterScope - Instructions for Use Click the icon to enter the following current ambient conditions. Entry ranges (°C or °F): Room Temperature: 17 to 34 °C or 62 - 93 °F Continue with . 2. Enter the current relative humidity in the room. Entry ranges: Relative Humidity: 30 to 75% Confirm with . 3. Enter the current relative ambient in the room. Entry ranges (hPa or mmHg): Absolute Pressure: 924 to 1043 hPa Confirm with . Page 76/233 Version 03.
MasterScope - Instructions for Use Press the button to verify and store the ambient room condition values. Press to make corrections. It is important that the correct units are used. You can adjust the ambient conditions at any time by clicking the icon in the Utilities tool-bar. Following that, select the icon shown on the left. Version 03.
MasterScope - Instructions for Use 7.2 Wireless Spirometry Sensor Check The ERT PTs included with the delivery are pre-calibrated as part of manufacture. A sensor check can be performed to confirm accurate measurement data. 7.2.1 Quality Control for Flow-Volume Measuring Devices in Compliance with ATS/ERS 2005 With regards to volume accuracy*1, calibration checks should be performed every day at least three times to give a range of flows varying between 0.
MasterScope - Instructions for Use Proceed as follows: 1. Press the icon. In the following screen you will be asked to verify the current ambient room conditions. Confirm with the button . Following window appears: 2. Use the 3-L calibration syringe for calibration. Connect the calibration syringe to the wireless spirometry sensor unit. 3. Press . An automatic zero adjustment of the connected pneumotach will be performed. The following window appears: Version 03.
MasterScope - Instructions for Use 4. Press to start zero adjustment. 5. The screen now shows you the standard flow/volume calibration graph. 6. Start to pump the calibration syringe with complete strokes - incomplete strokes could lead to errors. 7. The first three strokes are discarded and can be performed at any flow rate. A counter in the bottom right window will count down the number of strokes performed. The inhaled and exhaled volume of each stroke is recorded in the upper right window.
MasterScope - Instructions for Use With the completion of the calibration check, following window appears: If the calibration check is successful, exit the calibration check program with . Version 03.
MasterScope - Instructions for Use If any of the strokes are outside this limit, the calibration check will automatically stop, and the message “Measured volume is outside +/- 3% of the pump volume.“ will be displayed. Click and restart the calibration check with . If the check continues to fail, exchange the pneumotach and repeat this procedure. If it still fails, please contact ERT Customer Care.
MasterScope - Instructions for Use 7.2.3 Wireless Spirometry Sensor Linearity Check ERT PTs are pre-calibrated as part of their manufacture, as such MasterScope is a calibration-free device. It is possible to perform a linearity check to confirm that the device is measuring as expected. A 3L syringe used for such a check is not included as standard, but can be purchased on demand.
MasterScope - Instructions for Use 3. Press to start the procedure. An automatic zero adjustment of the connected pneumotach will be performed. The following window appears: 4. Press to start zero adjustment. 5. The screen now shows you the standard flow/volume calibration graph. 6. Start to pump the calibration syringe with complete strokes - incomplete strokes could lead to errors. 7. The first three strokes are discarded and can be performed at any flow.
MasterScope - Instructions for Use 8. After completing the discard strokes, the lower right window changes and will instruct you to perform strokes in the low flow range. The screen will change to the standard flow/volume calibration graph with the low flow range highlighted in yellow. Perform the calibration maneuver with three complete strokes in the low flow range.
MasterScope - Instructions for Use 9. When both sides of the graph are green, the screen will then show the mid flow range highlighted in yellow. Perform the calibration maneuver with three complete strokes in the mid flow range. When both sides of the graph are green, the screen will then show the high flow range highlighted in yellow. Perform the calibration maneuver with three complete strokes in the high flow range. The maximum number of strokes is 15.
MasterScope - Instructions for Use 10. The result of each pump stroke is displayed in the upper right window. “Green” means better than +/- 3.5%. If the linearity check is successful (all areas are green), exit the linearity check program with . Version 03.
MasterScope - Instructions for Use If any of the strokes are outside this limit, the calibration check will automatically stop, and the message “Measured volume is outside +/- 3.5% of the pump volume.“ Click and restart the linearity check with . If the check continues to fail, try changing the pneumotach head, and repeat the linearity check. If this also fails, please contact ERT Customer Care.
MasterScope - Instructions for Use 8. Visit A visit is a summary of various measurement of different levels and activities for the currently active subject. Visit Selection shows the next visit planned and available other visits Visit Summary shows a summary of visits performed including key results performed Visit Calendar shows planned visits (including ranges) Subject Details shows the demographic data of the current subject 8.1 Visit Selection Shows the next planned visit(s).
MasterScope - Instructions for Use 8.2 Visit Summary For the currently active subject, the visit summary shows • Visits performed • Date and time of performed actions • Operator • Action type • Action details • Detail (detailed report view - see next page) • Edit • Print • Messages indicating criteria which were met or not. Click this icon to switch to the detailed report view of the respective visit. Page 90/233 Version 03.
MasterScope - Instructions for Use Detailed report view: Click and the entered operator comment can be overwritten. The comment is saved with . Change operator comment is only applicable until the measurement results have been transferred via Data Transfer to the ERT Data Center. Version 03.
MasterScope - Instructions for Use 8.3 Visit Calendar Shows all visits performed and planned for the current subject. Page 92/233 Version 03.
