Instructions for Use MasterScope · Spirometry · ECG 782126-WSSU Version 03.
MasterScope - Instructions for Use Product names or services are trademarks of their respective companies. All rights, including those of translations, are reserved. Written permission of eResearchTechnology (ERT) shall be obtained for the reproduction of this manual or any excerpt thereof by any means, including printing, photo static duplication, microfilms, or any other processes. eResearchTechnology GmbH Sieboldstrasse 3 97230 Estenfeld, Germany Tel: +49 9305 720-9891 Fax: +49 9305 720-7891 www.ert.
MasterScope - Instructions for Use Table of Contents Indication for Use................................................................................................... 6 ERT Customer Care Contacts................................................................................. 7 Notes on Safety in Instructions for Use................................................................... 9 Declaration of Conformity......................................................................................
MasterScope - Instructions for Use 7.2.2 7.2.3 8. 8.1 8.2 8.3 8.4 9. 9.1 9.2 9.3 9.3.1 9.4 9.5 9.6 9.7 9.8 9.9 9.10 9.11 10. 10.1 10.1.1 10.1.2 10.1.3 10.1.4 10.1.5 10.1.6 10.2 10.2.1 10.2.2 10.2.3 10.3 10.4 10.5 10.6 11. 11.1 11.2 12. 12.1 12.2 12.3 13. 13.1 13.1.1 13.1.2 13.1.3 13.1.4 14. 15. 15.1 15.1.1 Page 4/233 Wireless Spirometry Sensor Calibration Check (ERT PT Check)................ 78 Wireless Spirometry Sensor Linearity Check............................................ 83 Visit................
MasterScope - Instructions for Use 15.2 Installation of Software Update via SD Card or USB Stick..................... 193 15.2.1 Optional Actions.................................................................................. 197 15.3 Date/Time Check and Correction......................................................... 199 16. Data Corrections and Communications........................................... 202 16.1 New DCR...................................................................................
MasterScope - Instructions for Use This document contains copyright information. All rights are reserved. It is not allowed to copy, duplicate or translate this manual in any other language without obtaining written approval from ERT. ERT reserves the right to alter the information included in this document without notice. Names of persons mentioned in the context of this manual are fictitious - any resemblance to living or deceased persons is purely incidental and not intended.
MasterScope - Instructions for Use ERT Customer Care Contacts Available 24 hours a day, 7 days a week, year-round ERT’s Global Customer Care team is always available to address any questions, concerns or equipment needs. You can request immediate assistance by calling the helpdesk team. Alternatively, send us an email or fax using the information below. ERT’s Global Customer Care team is always available for technical support. A trained specialist is standing by for your call now.
MasterScope - Instructions for Use Contact Us by Email You can email questions and comments to the Global Helpdesk at customercare@ert.com Our approximate turnaround time for incoming emails is 48 hours (during business days). If your request is urgent, please call the ERT Helpdesk for immediate assistance using the telephone number for your country above. International Support is responsible for all hardware and software issues and should be contacted as soon as a problem occurs at a site.
MasterScope - Instructions for Use Notes on Safety in Instructions for Use Following the ANSI recommendations (American National Standards Institute) for safety notes, specific passages of the Instructions for Use are clearly marked as safety notes. Degree of Danger Injury to Persons Damage Use in case of: to Property X DANGER indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. This signal word is to be limited to the most extreme situations.
MasterScope - Instructions for Use Introduction The MasterScope is a customized system used to support clinical studies. This manual will guide you through setting up and operating the MasterScope. Training All individual users of the MasterScope equipment must have had a training session by a certified trainer. Safety Along with the practical information required to use the MasterScope, the MasterScope Instructions for Use contains important safety information.
MasterScope - Instructions for Use Printer Prior printing with the MasterScope, the delivered printer has to be prepared and connected to the MasterScope. The following description applies to any printer model supported by the MasterScope. Only printer models provided by ERT can be used with the MasterScope system. Remove the protection tapes from the printer and open the paper feed holder and the front panel. Remove the blue transport protection, if enclosed.
MasterScope - Instructions for Use Open the lid of the printer. The printer head will move to the cartridge loading position. Unlock the blue and grey handles and insert the ink cartridges. Lock the handles. The cartridge number can vary by printer models! The pictures above are just examples in regards to the cartridge number.
MasterScope - Instructions for Use The printer is pre-configured by ERT. There is no need to go into the Setup menu to configure the printer. Please ensure to plug in the power cord, insert paper and cartridges, connect it to the MasterScope, switch it on and the printer is ready to use.
MasterScope - Instructions for Use 1. The MasterScope Setup (Fujitsu E756) 1.1 Installing the Battery in the Notebook Due to regulatory safety for Lithium Ion batteries transportation it is necessary to remove the battery from the notebook before shipping. 1. 2. 3. 4. 5. Remove the notebook battery from foil package. Position the battery at the edge. Insert the battery into the battery compartment until it engages positively (1). Slide the release button in the direction of the arrow (2).
MasterScope - Instructions for Use 1.2 Removing the Battery from the Notebook Before shipping the device the battery must be removed from the notebook! 1. 2. 3. 4. Slide the release button in the direction of the arrow (1). Slide the release button in direction of the arrow (2) and hold it in place. Remove the battery from the battery compartment (3). Place the battery in the foil package next to the notebook in the MasterScope shipping box. 1.
MasterScope - Instructions for Use 1.4 Connecting the MasterScope Accessories (Fujitsu E756) All MasterScope accessories must be connected to the Equipment Bag and the MasterScope.
MasterScope - Instructions for Use 2. Turning on the MasterScope Connect your MasterScope to a power socket which corresponds to the local regulations (110/240V). Turn the MasterScope ON using the power switch on the keyboard. After turning on the MasterScope, please wait for about 5 minutes before starting the first measurement. The notebook is protected by a power-on password, which will be distributed by ERT during the training session.
MasterScope - Instructions for Use 2.2 MasterScope First Time Use The MasterScope must be installed with the protocol-specific software prior to system use. When the system is turned on for the first time, the MasterScope Configuration Wizard will start and will guide the user through the process. There are two options to install the MasterScope: 1. Online Setup: Install the software via internet download 2. Offline Setup: Install the software via setup medium, e.g. SD Card or USB stick. 2.2.
MasterScope - Instructions for Use Step 2: Connect peripherals and turn on MasterScope Connect all peripherals as described in chapter 1.4 and turn on MasterScope. Enter the power on password (received during the training) and the configuration wizard will appear. Click to start the setup wizard. Click
MasterScope - Instructions for Use Step 3: Establish an internet connection first (WiFi or Lan) It is necessary to establish an internet connection before the protocol specific software can be downloaded and finished. Select the preferred internet connection (WiFi or LAN) according to your local IT settings and click to continue. For more detailed information about the MasterScope internet settings click on .
MasterScope - Instructions for Use The example screen above shows LAN (Ethernet) internet settings. Please refer to the data transfer setings chapter for more detailed information. The “green indicator - Internet available” indicates if an internet connection has been established. It will be red if there is no internet connection available. If so, ensure the settings are correct according to your local IT environment. Version 03.
MasterScope - Instructions for Use Step 4: Download the study-specific software with your MyStudyPortal account and the SQF PIN Enter the following information to download the protocol-specific software: SQF PIN: Site Qualification PIN received from ERT. This PIN is protocol specific. Enter your e-mail address as registered for ERT’s My Study Portal Email: Password: Enter your password as registered for ERT’s My Study Portal. The SQF PIN is case sensitive! Ensure that it is entered correctly.
MasterScope - Instructions for Use Ensure that according to the SQF PIN entered in the previous sceen, the software which will be installed is correct. If not, please verify the SQF PIN used and correct it by clicking on the button. If the software matches the protocol which shall be installed, click to start the software download. If the wrong protocol is setup on the system, it is necessary to ship the device back to ERT and receive a new system! Version 03.
MasterScope - Instructions for Use Step 5: Download and Install Software Please wait until the download is complete. Do not shut down/switch off the MasterScope or disconnect the internet connection during this process! This can take several minutes depending on your internet connection speed. Page 24/233 Version 03.
MasterScope - Instructions for Use After the successful download the installation will start automatically. Once completed, the system will restart automatically. Please wait until the installation is complete. Do not shut down/switch off the MasterScope during this process! This can take several minutes. Version 03.
MasterScope - Instructions for Use Step 6: Site Configuration After the successful software installation and reboot of the system, the MasterScope configuration wizard will appear. Now, the site-specific information will be setup. Click to start the site configuration process. Page 26/233 Version 03.
MasterScope - Instructions for Use The site your My Study Portal account is registered for (which you used at step 4) is automatically displayed in the drop down. Select it and click to continue. If the My Study Portal account has access to multiple sites, e.g. CRA then in the drop down all sites will be listed according to the user’s access rights. Then select the site the system should be configured for. Version 03.
MasterScope - Instructions for Use Review the site information and correct where necessary with clicking on . If all information is correct, click to continue. Page 28/233 Version 03.
MasterScope - Instructions for Use Step 7: User Fingerprint Registration During the download process all users which have already been registered via SQF for the particular site were downloaded to the MasterScope. For these it is necessary to register their fingerprints for the login. If a user was not created via SQF and downloaded, then it is still possible to add the user manually on the MasterScope.
MasterScope - Instructions for Use Then register your fingerprint by selecting a finger. Put the respective finger 4 times on the fingerprint sensor. It is recommended to register a second finger. Click when the fingers have been registered successfully. Page 30/233 Version 03.
MasterScope - Instructions for Use A summary screen will show the User Information. Click on to amend any information. All user information were downloaded from ERT’s My Study Portal account. Any changes which will be done on the MasterScope to the User Information will not be synchronized with ERT’s My Study Portal account. Version 03.
MasterScope - Instructions for Use If you go to the User Management via the Tools menu and select “Show deactivated users”, the system will display all users who have been registered for this site via SQF already. These users were downloaded automatically. Just select the user who should also get access and click on to add the fingerprints. There is no need to add them as new users. If a user is not listed at all, then click on .
MasterScope - Instructions for Use Step 2: Connect peripherals and turn on MasterScope Connect all peripherals as described in Chapter 1.4 and turn on the MasterScope. Enter the power-on password (received during the training) and the configuration wizard will appear. Click to start the site configuration process. Version 03.
MasterScope - Instructions for Use Step 3: Install the software Insert the setup medium into the MasterScope laptop computer and install the software. Ensure that the update medium is inserted in the MasterScope and click
MasterScope - Instructions for Use Make sure that the protocol information listed is the correct protocol which the system must be setup for and click on . If the wrong protocol is setup on the system, it is necessary to ship the device back to ERT and receive a new system! Version 03.
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MasterScope - Instructions for Use After the successful preparation the installation will start automatically. Once completed, the system will restart automatically. Please wait until the installation is complete. Do not shut down/switch off the MasterScope during this process! This can take several minutes. Version 03.
MasterScope - Instructions for Use Step 4: Site Configuration After the successful software installation and reboot of the system, the MasterScope configuration wizard will appear. Now, the site-specific information will be setup. Click to start the site configuration process. Page 38/233 Version 03.
MasterScope - Instructions for Use Enter all site information and click . Version 03.
MasterScope - Instructions for Use Select the time zone, date and time of your site location. Please check if your country uses daylight saving time and click on . Page 40/233 Version 03.
MasterScope - Instructions for Use Select your preferred system language and click on . There are only languages listed which are available for the particular protocol setup. If your preferred language is not available, please use English language. Version 03.
MasterScope - Instructions for Use A summary screen shows all of your settings done: To accept these settings, click on . In order to change some of the above data, click and repeat data entry. The MasterScope setup starts automatically. This procedure may take a few minutes. During the setting up the system: • Make sure that the laptop computer is not running on battery power. • Do not switch off the laptop computer. • Do not remove the setup medium. Page 42/233 Version 03.
MasterScope - Instructions for Use When the setup of the system was successful, the SQF PIN Validation screen will appear: In order to start registering users for the system you need to enter the SQF PIN (Site Qualification Form PIN) which you have received by e-mail. Then, click . The SQF PIN entry is case sensitive! Version 03.
MasterScope - Instructions for Use 2.3 MasterScope User Registration In order to register site personnel on the MasterScope, the user name must be entered and at least two different fingers must be registered using the fingerprint sensor. The MasterScope User Registration can be started in three different ways: First, by using the My Study Portal account as described under Online Setup chapter or by using the SQF PIN as described under the Offline Setup chapter.
MasterScope - Instructions for Use Third, new users can be registered if none of previous registered users are available. For doing this, follow the steps below: 1. Go to the login screen and click on the “Temporary Password” tab. 2. User Name: “Enroll”. 3. Call Customer Care and explain the situation why to receive a one-time password. Follow Customer Care instructions. 4. Enter the password provided by Customer Care. 5. Click to continue. 6.
MasterScope - Instructions for Use 2. The MasterScope User Registration main screen shows the previously enrolled users. To create a new user, click the button. The following screen appears: Prior to creating a new user, the enrolled user has to verify again. Page 46/233 Version 03.
MasterScope - Instructions for Use 3. Enter the new user name (maximum of 8 characters) and fill in the other fields. Fields marked with an asterisk (“*”) are mandatory. Check, if portal access is needed. For portal access it is necessary to enter the email address. Monitor or Site Administrator rights are only to be granted to CRAs/Site Administrators involved in the study. This allows them to register new site users or perform specific functions.
MasterScope - Instructions for Use Select a finger by clicking on the respective box above. Instruct the new user to press the selected finger onto the biometric fingerprint sensor flat to the surface with moderate pressure. This has to be repeated 3 times for capturing 3 more fingerprints of the same finger. Please ensure that the user understands that his/her fingers must be dry prior to the fingerprint registration. Page 48/233 Version 03.
MasterScope - Instructions for Use As soon as the fingerprint is successfully scanned four times, the button becomes available. It is possible to register a second fingerprint. In order to do that, select another finger by clicking on the respective box above and continue as described on the previous page. It is recommended to register two fingers, the same finger on both hands. Version 03.
MasterScope - Instructions for Use Click . Following screen appears: Click to return to the MasterScope User Registration main screen. Page 50/233 Version 03.
MasterScope - Instructions for Use 3. The Wireless Spirometry Sensor Solution (WSSS) LED Status Indicator ERT PT with Mouthpiece Power On/Off The Wireless Spirometry Sensor Unit must not be exposed to direct sunlight nor positioned immediately near heating elements. 3.1 Wireless Spirometry Charging Station Ensure the Wireless Spirometry Sensor Unit is permanently charged if not in use. Insert the sensor into the charging station and plug in the power cord to the wall socket for charging.
MasterScope - Instructions for Use Connect the other end of the power cable (mini USB connector) on the backside into the charging station. 3.2 Charging the Wireless Spirometry Sensor Unit Put the wireless spirometry sensor unit into the slot of the charging station as shown below. Wireless Spirometry Sensor Unit Charging station Page 52/233 Version 03.
MasterScope - Instructions for Use LEDs indication wireless spirometry sensor unit: LED Indication Description Action Orange LED on Charging in cradle Orange LED off No charging/charging complete in cradle Orange LED blinking slowly Low battery Put the wireless sensor unit into charging station. Orange LED blinking fast Indicates an error of wireless spirometry sensor unit Indicates an error in the Wireless Spirometry Sensor Unit.
MasterScope - Instructions for Use 3.3 Switch on the Wireless Spirometry Sensor Unit Prior to usage, switch on the Wireless Spirometry Sensor Unit by pressing the “Power on” button for at least 3 seconds. Once switched on and connected to the MasterScope the blue LED is blinking slowly. 3.4 Prepare Wireless Spirometry Sensor Unit for a Measurement (Insert and Remove ERT PT) Insert an ERT PT into the wireless spirometry sensor unit and attach a mouthpiece.
MasterScope - Instructions for Use 3.5 Device Management Wireless Spirometry Sensor Unit Navigate to the “Tools Menu” and click on . Details about the connected Wireless Spirometry Sensor Units can be found under the device entry “Spirometry Sensor” which are: • ERT Sensor Unit #: ERT-SU-xxxxxxxx (Default): In case multiple sensors are paired only one sensor will be defined as default.
MasterScope - Instructions for Use Ensure the charging station is power plugged in. Ensure to turn on the Wireless Spirometry Sensor Unit and place it into the charging station. Click to start the pairing process. Page 56/233 Version 03.
MasterScope - Instructions for Use Paring is only possible for 90 seconds after the Wireless Spirometry Sensor Unit is placed into the charging station (Sensor visible via bluetooth). If the sensor cannot be discovered, remove the sensor from the charging station and reinsert it. Then repeat the steps. Version 03.
