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ERT MasterScope WSCS01 Instructions For Use Manual

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Instructions for Use
MasterScope
· Spirometry
· ECG
782126-WSSU
Version 03.00

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Summary of Contents for ERT MasterScope WSCS01

  • Page 1 Instructions for Use MasterScope · Spirometry · ECG 782126-WSSU Version 03.00...
  • Page 2 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.

  • Page 3: Table Of Contents

    Charging the Wireless Spirometry Sensor Unit ........52 Switch on the Wireless Spirometry Sensor Unit ........54 Prepare Wireless Spirometry Sensor Unit for a Measurement (Insert and Remove ERT PT) ..............54 Device Management Wireless Spirometry Sensor Unit ......55 Subject, Proficiency and Training Mode ........... 59 Subject Mode ..................
  • Page 4 MasterScope - Instructions for Use 7.2.2 Wireless Spirometry Sensor Calibration Check (ERT PT Check) ....78 7.2.3 Wireless Spirometry Sensor Linearity Check ........... 83 Visit ..................... 89 Visit Selection ..................89 Visit Summary ..................90 Visit Calendar ..................92 Subject Details ..................93 Spirometry Measurement ..............
  • Page 5 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 Data Corrections and Communications .......... 202 16.1 New DCR ................... 202 16.2 DCR Overview ..................

  • Page 6: Indication 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.

  • Page 7: Ert Customer Care Contacts

    ERT’s Global Customer Care team is always available for technical support. A trained specialist is standing by for your call now. Please be sure to have your ERT study name, Portal account login or the ticket number for an existing case, if available.
  • Page 8 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.

  • Page 9: Notes On Safety In Instructions For Use

    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. Injury to Damage Degree of Danger Use in case of: Persons to Property...

  • Page 10: Introduction

    With the MasterScope, data can be transmitted via ethernet, wireless LAN, web upload or analog modem to the ERT Data Center. If a data transfer is not possible, data can be backed-up on a external media which is then sent to the ERT Data Center by mail.

  • Page 11: Printer

    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.

  • Page 12: Printer Hp 200

    Power LED lightning: Printer is turned on Power button Power LED dark: Printer is turned off On/Off Battery LED Not used with ERT configuration! Ensure that the printer power cable is always connected to use the printer (battery is not provided with the printer). Battery LED...
  • Page 13 MasterScope, switch it on and the printer is ready to use. ERT is not providing the battery for the printer! It works only if the power cable is plugged in! Power Adapter...

  • Page 14: The Masterscope Setup (Fujitsu E756)

    MasterScope - Instructions for Use The MasterScope Setup (Fujitsu E756) 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. Remove the notebook battery from foil package. 2.

  • Page 15: Removing The Battery From The Notebook

    MasterScope - Instructions for Use Removing the Battery from the Notebook Before shipping the device the battery must be removed from the notebook! 1. Slide the release button in the direction of the arrow (1). 2. Slide the release button in direction of the arrow (2) and hold it in place. 3.

  • Page 16: Connecting The Masterscope Accessories (Fujitsu E756)

    MasterScope - Instructions for Use Connecting the MasterScope Accessories (Fujitsu E756) All MasterScope accessories must be connected to the Equipment Bag and the MasterScope. USB1/ Power Fingerprint Supply Sensor Bag (bottom ) Bag (bottom ) USB2/ Spirometry Wireless Spirometry Handle Sensor Unit (WSSU) USB Stick USB3/...

  • Page 17: Turning On The Masterscope

    The notebook is protected by a power-on password, which will be distributed by ERT during the training session. Running system on power supply If the MasterScope is not connected to the power supply while in use, a warning message is displayed on top of the screen.

  • Page 18: Masterscope First Time Use

    MasterScope) before the online setup can be performed on the MasterScope. What is SQF? Before any site can start working in a clinical trial with ERT systems it is necessary to register the site in ERT’s My Study Portal (MSP). MSP is ERT’s online system that provides access to reports, queries, supply ordering and reference materials.
  • Page 19 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 <Next>...
  • Page 20 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 <Next>...
  • Page 21 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.
  • Page 22 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. Email: Enter your e-mail address as registered for ERT’s My Study Portal Password: Enter your password as registered for ERT’s My Study Portal.
  • Page 23 If the software matches the protocol which shall be installed, click <Next> 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 03.00 • Date 19FEB2020 Page 23/233...
  • Page 24 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 03.00 •...
  • Page 25 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 03.00 •...
  • Page 26 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 <Next> to start the site configuration process. Page 26/233 Version 03.00 •...
  • Page 27 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 <Next> 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.
  • Page 28 MasterScope - Instructions for Use Review the site information and correct where necessary with clicking on <Edit>. If all information is correct, click <Install> to continue. Page 28/233 Version 03.00 • Date 19FEB2020...
  • Page 29 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.
  • Page 30 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 <Save> when the fingers have been registered successfully. Page 30/233 Version 03.00 •...
  • Page 31 A summary screen will show the User Information. Click on <Change> 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.

  • Page 32: Masterscope Offline Setup

    Update medium (SD Card or USB Stick) Ensure the setup medium (SD Card or USB stick) with the most currrent protocol- specific software version has been received from ERT. Have it ready before continuing with the next steps. Page 32/233...
  • Page 33 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 <Next>...
  • Page 34 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 <Use Update medium> to continue with the offline setup. Page 34/233 Version 03.00 •...
  • Page 35 <Next>. 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 03.00 • Date 19FEB2020 Page 35/233...
  • Page 36 MasterScope - Instructions for Use Page 36/233 Version 03.00 • Date 19FEB2020...
  • Page 37 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 03.00 •...
  • Page 38 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 <Next> to start the site configuration process. Page 38/233 Version 03.00 •...
  • Page 39 MasterScope - Instructions for Use Enter all site information and click <Next>. Version 03.00 • Date 19FEB2020 Page 39/233...
  • Page 40 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 <Next>. Page 40/233 Version 03.00 • Date 19FEB2020...
  • Page 41 MasterScope - Instructions for Use Select your preferred system language and click on <Next>. 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 03.00 • Date 19FEB2020 Page 41/233...
  • Page 42 MasterScope - Instructions for Use A summary screen shows all of your settings done: To accept these settings, click on <Install>. In order to change some of the above data, click <Edit> and repeat data entry. The MasterScope setup starts automatically. This procedure may take a few minutes.
  • Page 43 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 <OK>. The SQF PIN entry is case sensitive! Version 03.00 •...

  • Page 44: Masterscope User Registration

    MasterScope - Instructions for Use 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.
  • Page 45 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.
  • Page 46 MasterScope - Instructions for Use 2. The MasterScope User Registration main screen shows the previously enrolled users. To create a new user, click the <Create new user> button. The following screen appears: Prior to creating a new user, the enrolled user has to verify again. Page 46/233 Version 03.00 •...
  • Page 47 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.
  • Page 48 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.
  • Page 49 MasterScope - Instructions for Use As soon as the fingerprint is successfully scanned four times, the <Save> 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.
  • Page 50 MasterScope - Instructions for Use Click <Save>. Following screen appears: Click <Cancel> to return to the MasterScope User Registration main screen. Page 50/233 Version 03.00 • Date 19FEB2020...

  • Page 51: The Wireless Spirometry Sensor Solution (Wsss)

    MasterScope - Instructions for Use 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. Wireless Spirometry Charging Station Ensure the Wireless Spirometry Sensor Unit is permanently charged if not in use.

  • Page 52: Charging The Wireless Spirometry Sensor Unit

    MasterScope - Instructions for Use Connect the other end of the power cable (mini USB connector) on the backside into the charging station. Charging the Wireless Spirometry Sensor Unit Put the wireless spirometry sensor unit into the slot of the charging station as shown below.
  • Page 53 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 Low battery Put the wireless sensor unit into charging slowly station.

  • Page 54: Switch On The Wireless Spirometry Sensor Unit

    ERT PT with mouthpiece Rail with sensor holes ERT PT is only for single use. Do not reuse the ERT PT due to risk of cross contamination. Do not remove the mouthpiece from the ERT PT. Only use the ERT PT with connected mouthpiece.

  • Page 55: Device Management Wireless Spirometry Sensor Unit

    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. • Default: Indicates if multiple wireless spirometry sensor units are paired which of the sensors is used as “Default”...
  • Page 56 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 <Continue> to start the pairing process. Page 56/233 Version 03.00 • Date 19FEB2020...
  • Page 57 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.

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