MasterScope - Instructions for Use How Web Upload Data Transfer Works 1. In the Utilities bar, click on the icon to initiate the data transfer process. 2. Select SD card as the method to transfer the clinical data and press the button. Please do not change this setting until you are instructed from the ERT Customer Care Helpdesk. 3. Ensure that the “Transfer” SD card is not in the write protected status (not applicable if USB Transfer Kit was delivered).
MasterScope - Instructions for Use 5. Confirm the formatting of the SD card or USB stick by pressing the button. Please do not store any data except the MasterScope data files on the medium. 6. The progress of the data transfer process will be indicated in the screen below: Please do not remove the SD card or USB stick until instructed to ensure a correct and complete data transfer! Page 172/233 Version 03.
MasterScope - Instructions for Use 7. Remove SD card or USB stick after the data is successfully copied to the external medium (indicated by the screen below). 8. Click to proceed with the upload of the data on the web-based PC. How the Data Upload Works Using MyDataUploader™ 1. Please insert the SD card or connect the USB stick which includes the transfer file from the MasterScope to the web-enabled PC. sfer Tra n USB stick Web-enabled PC Version 03.
MasterScope - Instructions for Use In the case that the computer has no SD card slot, please use the provided USB SD card reader as shown below: sfer Tran SD card and USB SD card reader Site computer 2. Open your internet browser and go to the MyDataUploaderTM webpage by entering the following address: https://mdu.ert.com 3. Clicking the button will start the data transfer.
MasterScope - Instructions for Use 4. Please select the data transfer file for upload by selecting the button. In the following file, open the dialog of your browser, search and select the SD card or USB stick drive labeled “Transfer”. Then search and select the single data transfer file. The file name starts with “MScCT32_ “(see example below). 5. If the selected file is valid, the next screen will display your study information. See example below. Version 03.
MasterScope - Instructions for Use 6. If you would like to receive the Confirmation Code additionally via email, please enter your email address in the corresponding entry field below the study information. 7. Clicking the button will start the data transfer. The duration of the upload depends on your internet connection and the size of the data transfer file. In case you experience any problems, please contact the ERT Customer Care Helpdesk.
MasterScope - Instructions for Use The confirmation code is a 8-digit alphanumeric code which is displayed when the data was successfully uploaded to the ERT data center. Example: ABCD1234 (as shown above) 9. Please record the code exactly as displayed, print it or it will be sent to you via email. • To print the confirmation code, please click the button. This will open your standard printer dialog and you can proceed as usual.
MasterScope - Instructions for Use How to Confirm the Data Transfer on MasterScope 1. Please enter the confirmation code on the MasterScope (see screen on previous page). A detailed description on how to get the Confirmation Code can be found under “How the data Upload works using MyDataUploaderTM”. To avoid large data transfer files with the next data transfer, it is recommended to confirm the data transfer with the confirmation code immediately after the upload.
MasterScope - Instructions for Use In case you want to confirm the web upload transfer via the tools section, please • Select from the Utilities bar. • Choose . • Enter and confirm the confirmation code in the following screen. 13.1.4 Analog Modem Data Transfer Data is transferred via an analog line. If your phone line does not work, please try the fax line. In the Utilities bar, click on the icon. Select “Modem Data Transfer”.
MasterScope - Instructions for Use The progress of the download process will be displayed by a bar indicator. When the modem data transfer is complete, the following screen will appear: Click to exit. In case the analog modem transfer is not successful please verify your modem settings or try another transfer methodology. If you are still unable to transmit the data, contact the CRA or ERT Customer Care. Page 180/233 Version 03.
MasterScope - Instructions for Use 13.1.4.1 Data Transmission Settings To enable the data communication with the data center via modem, the modem settings in the MasterScope must be set correctly. Please note that with Fujitsu E756 analog data transmission is not supported anymore. Please use WiFi/LAN or SD Card upload instead. Confirm with and the following screen appears: Version 03.
MasterScope - Instructions for Use Enter in “Prefix” the number which needs to dialed for an outside line of your building followed by a “comma” for a pause. If no prefix is necessary within your building to get an outside line then the field must be empty. Do not change any other settings unless instructed by ERT Customer Care! For most of the countries, toll-free telephone numbers to the data center are established, i.e. the phone call to the data center is free of charge for the investigator.
MasterScope - Instructions for Use 14. Backup At the end of each visit day, the data generated by the MasterScope must be backed up onto a removable storage medium (SD Memory Card or USB stick). When shutting down, the system reminds you to perform a backup. The backup also includes all measurement reports created on the MasterScope and overread result reports (only supported if you use WiFi/LAN for data transmission). This will allow that the PDFs can be viewed and printed on any other computer as well.
MasterScope - Instructions for Use For performing a backup, select from the Utilities bar. Click on in the “Administration” tab. Depending on your study setup the system is delivered either with SD cards or USB sticks for performing the backup. Backup Backup The system asks you to insert Backup media “A“ or “B“. A Page 184/233 Insert the SD medium into the corresponding slot of the MasterScope. Version 03.
MasterScope - Instructions for Use BACKUP A The system asks you to insert the USB stick. Insert the USB stick into the corresponding slot of the MasterScope. Click to start the backup procedure. The following message screen appears: Confirm with . Version 03.
MasterScope - Instructions for Use The progress of the backup procedure is shown in the following screen: Page 186/233 Version 03.
MasterScope - Instructions for Use If the backup is complete, you are asked to remove the backup medium: Click to finish the backup process. Do not perform a backup if you have a severe system error or database error. Contact the CRA or ERT Customer Care person first. Please ensure that the backup media are stored separately from the notebook. In case of an unexpected data loss, the backup serves as source to restore your MasterScope. Version 03.
MasterScope - Instructions for Use 15. MasterScope Software Updates 15.1 Online Update Everytime when the MasterScope transmits the data to the data center, it will automatically check if there are any new software updates available. If so, the update(s) will be downloaded automatically after the data transfer. Once downloaded the new update(s) can be installed. There are two different updates possible to receive: • software update for protocol configuration, e.g.
MasterScope - Instructions for Use The following screen appears: Click to to start the Update Installation. After successful installation, the following will be displayed: Click to confirm. Version 03.
MasterScope - Instructions for Use Now, it is necessary to restart the system. Click to finish the procedure. For starting the process manually, select from the Utilities bar. Click on in the “Administration” tab. 15.1.1 Optional Actions - prints the release notes. If cannot be activated, click . A list appears showing visits of subjects which were started today.
MasterScope - Instructions for Use Open Visits in Training/Proficiency Mode: As an alternative, checkmark “Automatically close all open training/ proficiency visits”. If the warning sign is yellow , one or more visits are open in Training or Proficiency Mode. They can be closed automatically, if you set the flag “Automatically closed”. Version 03.
MasterScope - Instructions for Use Open Visits in Subject Mode: If the warning sign is red , one or more visits are open in the Subject Mode and the subject visits must be completed first. Page 192/233 Version 03.
MasterScope - Instructions for Use 15.2 Installation of Software Update via SD Card or USB Stick All update(s) will be provided typically via online download (see chapter Online Update). Your site will only receive the update via SD Card/USB Stick if you are having issues with the online download. Please get in touch with our Customer Care if you need to receive the update via SD Card/USB Stick.
MasterScope - Instructions for Use 2. Select in the menu bar on the right-hand side of the screen. 3. Select the tab. 4. Click on and the following screen will appear: Page 194/233 Version 03.
MasterScope - Instructions for Use Available updates are listed here separated by protocol update or windows update. By selecting an update, a respective “Release Note” will be displayed with detailed information about the update. Click to start the installation. Click to install the update later. Updates should be installed immediately after downloading.
MasterScope - Instructions for Use After successful installation, the following will be displayed: Click to confirm. Now, it is necessary to restart the system. Click to finish the procedure. For starting the process manually, select from the Utilities bar. Click on in the “Administration” tab. Page 196/233 Version 03.
MasterScope - Instructions for Use 15.2.1 Optional Actions - prints the release notes. If cannot be activated, click . A list appears showing visits of subjects which were started today. If these visits are complete already, the system offers to finalize these visits. If these visits are still ongoing, install the update after completing the visits.
MasterScope - Instructions for Use If the warning sign is yellow , one or more visits are open in Training or Proficiency Mode. They can be closed automatically, if you set the flag “Automatically closed”. Open Visits in Subject Mode: If the warning sign is red , one or more visits are open in the Subject Mode and the subject visits must be completed first. Page 198/233 Version 03.
MasterScope - Instructions for Use 15.3 Date/Time Check and Correction It might be necessary to check the date and time (and also time zone) of the system. Refer to the following steps: 1. Click on in the menu bar on the right-hand side of the screen. 2. Select the tab. 3. Click on and the following screen will appear: Version 03.
MasterScope - Instructions for Use The “Automatically adjust clock for daylight saving changes“ check box must be checked and ticked, if daylight savings apply to the respective time zone. The field is grayed, if no daylight saving time exists in the respective time zone. Please be careful with all changes here. Settings have an effect on all future measurement results. The use of this function is recorded in the Audit Trail. Continue with . Adjust date and time of your location.
MasterScope - Instructions for Use Enter a reason for the system time adjustment. Confirm with . Confirm with . Version 03.
MasterScope - Instructions for Use 16. Data Corrections and Communications 16.1 New DCR Using the Data Clarification Request Form, data corrections can be initiated from the site. These relate to data inconsistencies discovered by the site/CRA. DCRs will be submitted electronically. Fill out the data correction on the MasterScope. Refer to the following steps: 1. Click on in the menu bar on the right-hand side of the screen. 2. Select the tab. 2.
MasterScope - Instructions for Use Select the appropriate study visit, measurement and current value and enter the new date and time of the measurement. Please enter the reason for revision and confirm with .The following screen will appear: Version 03.
MasterScope - Instructions for Use Once completed click on . The system will now ask you for your fingerprint to confirm the correctness of the requested changes and to sign the DCR electronically. Page 204/233 Version 03.
