ERT MasterScope WSCS01 User manual

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

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MasterScope - Instructions for Use
Version 03.00 • Date 19FEB2020
Please note that this study specific MasterScope device may only be used if the
user attended a detailed training covering the applicable technical aspects of the
MasterScope and the associated peripherals.
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www.ert.com
© 2020 eResearchTechnology GmbH. All rights reserved.

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Table of Contents
Indication for Use.................................................................................................. 6
ERT Customer Care Contacts ................................................................................7
Notes on Safety in Instructions for Use ..................................................................9
Declaration of Conformity..................................................................................... 9
Introduction........................................................................................................10
What is MasterScope? ........................................................................................10
Printer ............................................................................................................11
Printer HP 200 .................................................................................................... 12
1. The MasterScope Setup (Fujitsu E756).............................................14
1.1 Installing the Battery in the Notebook................................................... 14
1.2 Removing the Battery from the Notebook............................................. 15
1.3 Faulty/Damaged Batteries ..................................................................... 15
1.4 Connecting the MasterScope Accessories (Fujitsu E756)........................ 16
2. Turning on the MasterScope ............................................................17
2.1 Login.................................................................................................... 17
2.2 MasterScope First Time Use .................................................................. 18
2.2.1 MasterScope Online Setup.................................................................... 18
2.2.2 MasterScope Offline Setup ................................................................... 32
2.3 MasterScope User Registration..............................................................44
3. The Wireless Spirometry Sensor Solution (WSSS)...........................51
3.1 Wireless Spirometry Charging Station ................................................... 51
3.2 Charging the Wireless Spirometry Sensor Unit ...................................... 52
3.3 Switch on the Wireless Spirometry Sensor Unit ..................................... 54
3.4 Prepare Wireless Spirometry Sensor Unit for a Measurement
(Insert and Remove ERT PT)................................................................... 54
3.5 Device Management Wireless Spirometry Sensor Unit........................... 55
4. Subject, Proficiency and Training Mode...........................................59
4.1 Subject Mode ....................................................................................... 59
4.2 Proficiency Mode.................................................................................. 59
4.3 Training Mode ...................................................................................... 59
4.4 Subject Mode Activation....................................................................... 60
5. Program Access..................................................................................62
5.1 Fingerprint Identification....................................................................... 62
5.2 Temporary Password............................................................................. 63
5.3 Remote Support ................................................................................... 64
6. System Overview ..............................................................................65
6.1 Main Menu .......................................................................................... 65
6.2 Dashboard............................................................................................ 66
6.3 Search/New Subject.............................................................................. 67
6.3.1 Search Subject...................................................................................... 67
6.3.2 New Subject ......................................................................................... 69
6.4 Waiting Room ...................................................................................... 70
6.5 Utilities ................................................................................................. 71
6.5.1 The Tools Menu .................................................................................... 72
6.6 Status Bar............................................................................................. 74
7. Ambient Conditions and Calibration Check.....................................75
7.1 Ambient Room Conditions ................................................................... 75
7.1.1 Ambient Sensor (Automatic Ambient Condition Registration) ............... 75
7.1.2 Manual Entry of Ambient Conditions.................................................... 75
7.2 Wireless Spirometry Sensor Check ........................................................ 78
7.2.1 Quality Control for Flow-Volume Measuring Devices
in Compliance with ATS/ERS 2005 ........................................................ 78

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7.2.2 Wireless Spirometry Sensor Calibration Check (ERT PT Check)............... 78
7.2.3 Wireless Spirometry Sensor Linearity Check........................................... 83
8. Visit.....................................................................................................89
8.1 Visit Selection ....................................................................................... 89
8.2 Visit Summary ...................................................................................... 90
8.3 Visit Calendar ....................................................................................... 92
8.4 Subject Details...................................................................................... 93
9. Spirometry Measurement .................................................................94
9.1 Basic Conditions prior to starting a Measurement ............................... 94
9.2 Slow Spirometry (VC and IC)................................................................. 95
9.3 Perform a Slow Spirometry Measurement ............................................. 97
9.3.1 Recording of Different SVC Maneuvers on the MasterScope ............... 102
9.4 Forced Spirometry Measurement......................................................... 107
9.5 Perform a Forced Spirometry Measurement.........................................108
9.6 ATS Criteria (ATS/ERS 2005) ................................................................ 115
9.7 Unacceptable Efforts .......................................................................... 117
9.8 Selection of Best Parameters............................................................... 119
9.9 Measurement Summary Result and Comments................................... 120
9.10 Review Results and Edit Comments ....................................................121
9.11 Amending Spirometry Measurements ................................................. 122
10. Resting ECG......................................................................................123
10.1 Information on ECG Recording ........................................................... 125
10.1.1 The Waveform.................................................................................... 125
10.1.2 ECG Leads.......................................................................................... 126
10.1.3 Chest ECG.......................................................................................... 126
10.1.4 Limb ECG ........................................................................................... 127
10.1.5 Basic Conditions for ECG Recording.................................................... 129
10.1.6 Preparing for the Measurement .......................................................... 129
10.2 Performing an ECG Recording ............................................................ 130
10.2.1 Electrode Test ..................................................................................... 130
10.2.2 ECG Recording ................................................................................... 132
10.2.3 ECG Evaluation................................................................................... 133
10.3 Recording Quality ECGs...................................................................... 136
10.4 Hygiene ECG ...................................................................................... 137
10.5 Additional Safety Notes for the ECG Amplifier .................................... 137
10.6 Technical Data ECG............................................................................. 141
11. Additional Visit Actions ..................................................................142
11.1 Rescheduling Visits ............................................................................. 142
11.2 Document Dosing Times for Post PFT and Serial Testing ...................... 142
12. Report Printing and Export to External Media.............................. 144
12.1 Report Printing ................................................................................... 144
12.2 Report Export ..................................................................................... 146
12.3 Printing Screenshots ........................................................................... 149
13. Data Transfer.................................................................................... 150
13.1 Data Transfer to the Data Center ........................................................ 150
13.1.1 Ethernet (LAN) Data Transfer............................................................... 151
13.1.2 Wireless LAN (WLAN) Data Transfer .................................................... 160
13.1.3 Web Upload Data Transfer.................................................................. 170
13.1.4 Analog Modem Data Transfer ............................................................. 179
14. Backup ..............................................................................................183
15. MasterScope Software Updates..................................................... 188
15.1 Online Update .................................................................................... 188
15.1.1 Optional Actions................................................................................. 190

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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 ........................................................................................... 202
16.2 DCR Overview .................................................................................... 206
17. Troubleshooting...............................................................................208
17.1 Fingerprint Sensor .............................................................................. 208
17.2 Backup Medium ................................................................................. 209
17.3 Notebook ........................................................................................... 209
17.4 Equipment Bag................................................................................... 209
17.5 Printer ................................................................................................ 209
18. Hygiene Wireless Spirometry Sensor Unit..................................... 211
18.1 Hygiene Regulations ........................................................................... 211
18.2 How often should Contaminated Parts be Exchanged? ....................... 211
18.3 Surface Cleaning and Disinfection.......................................................212
18.4 Precleaning and Disinfection............................................................... 212
18.5 Disposal of Single Use Items/Damaged Reusable Items........................ 213
19. General Safety Precautions............................................................. 214
19.1 Graphical Symbols .............................................................................. 219
19.2 Safety Precautions for Lithium Ion Rechargeable Batteries................... 221
Notes on EMC according to EN60601-1-2......................................................... 223
Return of Goods in Medical Institutions............................................................. 224
Technical Data Calibration Syringe.....................................................................228
Technical Data Wireless Spirometer Sensor Unit & Charging Station ..................228
Technical Data Ruuvitag Ambient Sensor...........................................................229
System Requirements........................................................................................230
Technical Data Laptop (Fujitsu E756) .................................................................230
Technical Data Accessories ................................................................................ 230
Index ..........................................................................................................231