Medoc TSA 2001 Product manual

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Small Fiber Test

Technical Reference

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Q-Sense Technical Reference Manual

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This User Manual contains proprietary information of Medoc Ltd. and may not be reproduced in

any form without prior written consent from Medoc Ltd.

DC 00076 Q-Sense Technical Reference Manual 12th Edition, Oct. 2018

Medoc Ltd.

1 Ha-Dekel St., PO Box 423 Ramat Yishai 3004627, ISRAEL

Tel.: +972-4-9038800 / Fax: +972-4-9038808

E-Mail [email protected]

www.medoc-web.com

Medoc U.S.A

Compass Medical Technologies, Inc.

1502 West Highway 54 - Suite 404

Durham, North Carolina, 27707, U.S.A

Tel.: +1-(919) 402-9600 / Fax: +1-(919) 402-9607

E-Mail: [email protected]

European Authorized Representative

CEpartner4U BV

Esdoornlaan 13 3951 DB Maarn, The Netherlands

Phone: +31 343 442.524 / Fax: +31 343 442 162

Mobile: +31 6 516 536.26

E-Mail: [email protected]

1282

This device complies with 93/42/EEC MDD

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Table of Contents

1Safety Guidelines and Regulations ............................................. 14

1.1 User Manual Icons ....................................................................................... 14

1.2 Intended use................................................................................................ 15

1.3 Target Population and Contraindications ..................................................... 15

1.4 Safety and Regulatory Summary .................................................................. 15

1.5 Safety Requirements .................................................................................... 16

1.5.1 Warnings ................................................................................................. 16

1.5.2 Cautions .................................................................................................. 17

1.5.3 Equipment Classification ............................................................................ 18

1.6 System Protection ........................................................................................ 18

1.6.1 System Self-Test ...................................................................................... 18

1.6.2 Temperature Safety Mechanisms ................................................................ 18

1.6.3 Thermode Detection .................................................................................. 18

1.7 Equipment Labels, Symbols, Warning Statements and Abbreviations .......... 19

1.8 Electromagnetic immunity ........................................................................... 20

1.9 Recommended Separation Distance between Portable and Mobile RF

Communications Equipment and Q-Sense ............................................................. 24

1.10 Technical Data .......................................................................................... 25

2Overview .................................................................................... 27

2.1 Training........................................................................................................ 27

2.2 System Description ...................................................................................... 27

2.3 Q-SENSE Thermode ...................................................................................... 27

2.4 Terminology ................................................................................................. 27

2.5 System Status .............................................................................................. 28

2.6 System States .............................................................................................. 28

2.7 Application Methods..................................................................................... 29

2.7.1 Limits Method........................................................................................... 29

2.7.2 Levels Method .......................................................................................... 29

2.7.3 Thermal Sensory Limen (TSL)..................................................................... 29

2.7.4 Ramp & Hold Method ................................................................................. 30

2.7.5 VAS Search Method ................................................................................... 31

2.7.6 Chain Option ............................................................................................ 32

3System Components................................................................... 33

3.1 Power side Panel.......................................................................................... 33

3.2 Connectors side panel .................................................................................. 34

4Setup and Installation ................................................................ 36

4.1 Computer Requirements .............................................................................. 36

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4.2 Installation USB Content .............................................................................. 37

4.3 Setup and Installation Main Steps................................................................ 37

4.4 Selecting a Location ..................................................................................... 37

4.5 Device Connections ...................................................................................... 38

4.6 Software Installation ................................................................................... 39

4.7 Unit Protection ............................................................................................. 40

4.8 Product Activation........................................................................................ 40

5Operation ................................................................................... 42

5.1 Power up Q-SENSE System........................................................................... 42

5.2 Starting Q-SENSE ......................................................................................... 42

5.3 System Self-Test .......................................................................................... 44

5.4 Basic Operation ............................................................................................ 45

5.4.1 Menu Bar ................................................................................................. 46

5.4.2 Toolbar .................................................................................................... 47

5.4.3 Search Row .............................................................................................. 47

5.4.4 Current Selection Information..................................................................... 48

5.4.5 Data Display Area ..................................................................................... 48

5.4.6 Q-Sense Status Line.................................................................................. 48

6Test Procedure and Management ............................................... 49

6.1 Selecting a Patient ....................................................................................... 49

6.2 Selecting a Program ..................................................................................... 50

6.3 Selecting a Body Site.................................................................................... 52

6.4 Running the Test .......................................................................................... 53

6.4.1 Test and Post-Test Options......................................................................... 55

6.4.2 Temperature Graph Display........................................................................ 56

6.4.3 Test Run Keyboard Shortcuts (Hot Keys) ..................................................... 56

7Program Management ................................................................ 58

7.1 Program List ................................................................................................ 58

7.2 Creating a New Program .............................................................................. 60

7.3 Removing a Program.................................................................................... 61

7.4 Duplicate A Program .................................................................................... 61

7.5 Edit A Program ............................................................................................. 61

7.6 Program Details ........................................................................................... 61

7.6.1 Limits ...................................................................................................... 62

7.6.2 Levels...................................................................................................... 66

7.6.3 Thermal Sensory Limen (TSL)..................................................................... 70

7.6.4 Ramp and Hold ......................................................................................... 73

7.6.5 VAS Search .............................................................................................. 75

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7.6.6 Chaining Programs .................................................................................... 77

7.6.7 Next Sequence Definition ........................................................................... 78

7.7 Standard Events ........................................................................................... 80

7.7.1 Standard Event Configuration ..................................................................... 80

7.7.2 List of Standard Events according to Program Type ....................................... 80

7.8 Test Instructions.......................................................................................... 81

7.9 Import / Export Program ............................................................................. 81

8Patient Management .................................................................. 83

8.1 Patients List ................................................................................................. 83

8.2 Add New Patient .......................................................................................... 85

8.3 Remove Patient ............................................................................................ 86

8.4 Edit Patient Details ...................................................................................... 86

8.5 Department Management............................................................................. 86

8.6 ICD 9 Management....................................................................................... 88

8.7 Import / Export Patient Lists ....................................................................... 88

9Results Management .................................................................. 90

9.1 Results List .................................................................................................. 90

9.2 Import / Export Results ............................................................................... 92

9.3 Print Results and Reports............................................................................. 95

9.3.1 Analysis Report Dialog ............................................................................... 95

10 System Configuration ............................................................... 105

10.1 Software Settings ................................................................................... 105

10.1.1 Communication........................................................................................106

10.1.2 Patient Fields...........................................................................................106

10.1.3 Results Fields ..........................................................................................110

10.1.4 Report Options ........................................................................................110

10.1.5 User Management ....................................................................................116

10.2 Hardware Settings .................................................................................. 123

10.2.1 General...................................................................................................123

10.2.2 Safety ....................................................................................................124

10.2.3 Thermode ...............................................................................................124

10.3 Test Settings ........................................................................................... 125

10.3.1 Test Configuration....................................................................................125

10.3.2 Instructions Configuration .........................................................................129

10.3.3 Body Site Editor.......................................................................................131

11 System Information ................................................................. 133

12 The Black box (Logger) ............................................................ 135

12.1 Exporting the Black Box File.................................................................... 135

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13 Appendix A –Normative Data................................................... 136

13.1 Normative Data License Agreement ........................................................ 136

13.2 Enable Normative Data ........................................................................... 137

13.3..................................................................................................................... 139

13.4 Normative Data Editor............................................................................. 139

13.4.1 Selecting the Normative Data Source (Built-In Tables)..................................139

13.4.2 Normative Data Tables .............................................................................140

13.5 Display of Normative Data in Tests, Results and Reports ........................ 143

14 Appendix B –Backing Up and Restoring the Database ............. 144

15 Appendix C - Accessories.......................................................... 145

16 Appendix D –System and Module Description.......................... 148

16.1 System Description ................................................................................. 148

17 Appendix E –Preventive and Periodical Maintenance............... 149

17.1 Periodical System Run and Visual Check ................................................. 149

17.2 Periodical Thermode Calibration ............................................................. 150

17.3 Periodical Thermode Maintenance........................................................... 150

18 Appendix F –Cleaning and Disinfecting.................................... 151

19 Appendix G - Thermode straps assembly instructions .............. 152

20 Appendix H –List of Accompanying Documents ....................... 153

21 Appendix I –Transportation and Storage conditions................ 154

22 Appendix J –Environmental Conditions ................................... 155

23 Appendix K –Upgrading procedure .......................................... 156

24 Appendix L –Troubleshooting –Operator Level ....................... 158

24.1 Numbered Software Error and Warning Messages .................................. 158

24.1.1 Frequent Warning Messages ......................................................................158

24.1.2 Frequent Error Messages...........................................................................162

24.2 Faulty System Responses........................................................................ 171

25 Appendix M –Licensed Options ................................................ 174

25.1 FTP Support ............................................................................................ 174

25.1.1 Export Configuration.................................................................................174

25.2 CoVAS ..................................................................................................... 176

25.2.1 CoVAS Calibration ....................................................................................176

25.3 Patient Record Control ............................................................................ 177

25.3.1 Control Patient Field Entry Format with Input Masks .....................................177

25.3.2 Add/Remove Patient Fields........................................................................178

25.4 Pain Rating ............................................................................................. 180

25.4.1 Pain Rating Parameters Configuration .........................................................180

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26 Appendix N –fMRI functionality............................................... 182

26.1 fMRI Thermode ....................................................................................... 182

26.1.1 Q-sense system configuration in fMRI mode: ...............................................182

26.1.2 Installation –MR Filter...............................................................................183

26.2 TTL functionality ..................................................................................... 186

26.2.1 Q-sense fMRI side panel ...........................................................................186

26.2.2 TTL set up...............................................................................................186

26.2.3 Standard Event Configuration ....................................................................187

26.2.4 TTL specifications.....................................................................................187

26.3 Blower control......................................................................................... 188

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List of Figures

Figure 1: Q-Sense Label ............................................................................................... 19

Figure 2: Ramp &Hold Sequence –Return to Baseline...................................................... 30

Figure 3: Ramp & Hold Sequence –Return to Next Destination ......................................... 31

Figure 4: VAS Search –Manual Mode............................................................................. 31

Figure 5: Power side panel ........................................................................................... 34

Figure 6: Connectors side panel .................................................................................... 34

Figure 7: Q-SENSE System Wiring Schema..................................................................... 35

Figure 8: Connecting Wall hanger to the wall .................................................................. 38

Figure 9: Q-SENSE System Wiring Schema..................................................................... 38

Figure 10: DC power port ............................................................................................. 39

Figure 11: Home screen product registration link ............................................................ 41

Figure 12: Q-sense COM port........................................................................................ 42

Figure 13: Home Screen............................................................................................... 43

Figure 14: Login Screen ............................................................................................... 43

Figure 15: Q-Sense Splash Screen................................................................................. 43

Figure 16: Self-Test Prompt.......................................................................................... 44

Figure 17: Q-Sense in Rest Mode .................................................................................. 45

Figure 18: Test Navigator –Main Menu .......................................................................... 45

Figure 19: Test Management Main Screen ...................................................................... 49

Figure 20: Patient Selection Menu ................................................................................. 50

Figure 21: Program Selection Menu ............................................................................... 51

Figure 22: Select Body Site screen ................................................................................ 52

Figure 23: Select Body Site –Specific site selection......................................................... 53

Figure 24: Pre-Test Screen ........................................................................................... 54

Figure 25: Real-Time Test ............................................................................................ 56

Figure 26: Program Management screen ........................................................................ 58

Figure 27: Program Management –Program Preview ....................................................... 59

Figure 28: Program graph preview ................................................................................ 60

Figure 29: New Program Screen .................................................................................... 60

Figure 30: Program Menu –Limits ................................................................................. 63

Figure 31: A Limits Method Test .................................................................................... 65

Figure 32: Statistical analysis of results ......................................................................... 65

Figure 33: Program Menu –Levels ................................................................................ 66

Figure 34: A Levels Method Test.................................................................................... 69

Figure 35: Statistical Analysis of the Results ................................................................... 70

Figure 36: Program Menu –TSL .................................................................................... 70

Figure 37: A TSL Method Test ....................................................................................... 72

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Figure 38: Statistical Analysis of the Results ................................................................... 73

Figure 39: Program Menu –Ramp and Hold.................................................................... 73

Figure 40: Program Editor –VAS Search ........................................................................ 75

Figure 41: Program Chain Editor ................................................................................... 77

Figure 42: Program Editor Next Sequence Definition ........................................................ 79

Figure 43: Manual Next Sequence definition ................................................................... 79

Figure 44: Standard Events in Program Editor................................................................. 80

Figure 45: Test Instructions Editor................................................................................. 81

Figure 46: Patients List ................................................................................................ 83

Figure 47: Patient Management –Patient details preview ................................................. 84

Figure 48: Patients Editor Screen .................................................................................. 85

Figure 49: Edit Department Menu.................................................................................. 87

Figure 50: Edit ICD Menu ............................................................................................. 88

Figure 51: Results List ................................................................................................. 90

Figure 52: Result preview display .................................................................................. 91

Figure 53: Export Result File Opened In Excel –Description Tab Sample ............................ 93

Figure 54: Export Result File Opened In Excel –Data Tab Sample ..................................... 93

Figure 55: Analysis Reports Dialog ................................................................................ 95

Figure 56: Analysis Report............................................................................................ 96

Figure 57: Single Results Report ................................................................................... 98

Figure 58: Multiple Results Report ................................................................................. 98

Figure 59: Site to Site Results Report ...........................................................................100

Figure 60: Pre / Post Results Report .............................................................................100

Figure 61: Trend Results Report ...................................................................................100

Figure 62: Custom Report Results ................................................................................100

Figure 63: Bilateral Results Report ...............................................................................101

Figure 64: Custom Report Configuration........................................................................103

Figure 65: Custom Report Configuration........................................................................104

Figure 66: Custom Report Configuration........................................................................104

Figure 67: Software Settings Dialog..............................................................................105

Figure 68: Open Software Settings ...............................................................................106

Figure 69: Software Settings - Patient Fields tab selection...............................................106

Figure 70: Software Settings - Patient Fields..................................................................107

Figure 71: Results Fields Configuration Screen ...............................................................110

Figure 72: Report Options tab......................................................................................111

Figure 73: Detailed Report example..............................................................................112

Figure 74: Detailed Report Options ...............................................................................113

Figure 75: Custom made Report Name dialog ................................................................114

Figure 76: Report Editor Screen ...................................................................................115

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Figure 77: Open Software Settings ...............................................................................116

Figure 78: Software settings users tab selection.............................................................116

Figure 79: Software Settings Users Tab.........................................................................116

Figure 80: Software Settings Add New User...................................................................117

Figure 81: Software settings filled ................................................................................118

Figure 82: Hardware settings –General tab...................................................................123

Figure 83: Hardware settings –Safety tab.....................................................................124

Figure 84: Hardware settings –Thermode tab................................................................125

Figure 85: Test Configuration Settings ..........................................................................126

Figure 86: Instructions Configuration............................................................................129

Figure 87: Test Instructions Editor................................................................................130

Figure 88: Audio save button .......................................................................................130

Figure 89: Body Sites Editor ........................................................................................131

Figure 90: System Information ....................................................................................133

Figure 91: Sysinfo File Sample .....................................................................................134

Figure 92: Black Box –Software ..................................................................................135

Figure 93: Normative Data Editor - Enable Normative Data .............................................137

Figure 94: Normative Data License Agreement...............................................................138

Figure 95: Normative Data Editor - Learn More ..............................................................139

Figure 96: Normative Data screen select source .............................................................140

Figure 97: Normative Data Editor .................................................................................141

Figure 98: Database Utility –Backup/Restore Menu........................................................144

Figure 99: System Diagram .........................................................................................148

Figure 100: Previous version message ..........................................................................156

Figure 101: Removing previos version screen ................................................................156

Figure 102: Data Backup Path......................................................................................156

Figure 103: MMS Uninstall ...........................................................................................157

Figure 104: Uninstall Completed ..................................................................................157

Figure 105: MMS successfully removed .........................................................................157

Figure 106: Error and Warning Messages Sample ...........................................................158

Figure 107: Open Software Settings .............................................................................174

Figure 108: Software settings export tab selection .........................................................174

Figure 109: Software Settings Export Tab .....................................................................175

Figure 110: CoVAS Calibration Tab ...............................................................................176

Figure 111: Patient Fields with Input Masks ...................................................................179

Figure 112: Patient Card with Selected Patient Fields ......................................................179

Figure 113: Pain Rating Parameters..............................................................................180

Figure 114: Pain Rating Limits .....................................................................................181

Figure 115: fMRI room setup .......................................................................................184

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