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PATHWAY
Pain & Sensory Evaluation
System
Technical Reference
Manual
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Pathway Technical Reference Manual
This device complies with 93/42/EEC MDD
0473
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 00054 PATHWAY Technical Reference Manual 26th Ed., October 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]
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Table of Contents
1. Safety Guidelines and Regulations ............................................. 15
1.1 User Manual Icons ........................................................................................... 15
1.2 Intended Use ................................................................................................... 16
1.3 Safety and Regulatory Summary ..................................................................... 16
1.4 Safety Requirements ....................................................................................... 16
1.4.1 Warnings ................................................................................................. 16
1.4.2 Cautions .................................................................................................. 17
1.4.3 Equipment Classification ............................................................................ 18
1.5 System Protection ........................................................................................... 18
1.5.1 System Self-Test....................................................................................... 18
1.5.2 Temperature Safety Mechanisms ................................................................ 18
1.5.3 Thermode Detection .................................................................................. 19
1.6 Equipment Labels, Symbols, Warning Statements and Abbreviations .............. 19
1.7 Electromagnetic Immunity .............................................................................. 21
1.7.1 Essential Performance: .............................................................................. 23
1.8 1.8 Recommended Separation Distance between Portable and Mobile RF
Communications Equipment and PATHWAY ........................................................... 24
1.9 Technical Data ................................................................................................. 25
1.9.1 PATHWAY – ATS model only ....................................................................... 25
1.9.2 PATHWAY – CHEPS model only ................................................................... 25
1.9.3 PATHWAY ATS and CHEPS models ............................................................... 26
2. Overview .................................................................................... 29
2.1 CHEPS Thermode ............................................................................................. 29
2.2 ATS Thermode ................................................................................................. 29
2.3 Switching Thermodes ...................................................................................... 30
2.4 Available Configurations .................................................................................. 30
2.5 Terminology .................................................................................................... 30
2.6 System Status ................................................................................................. 31
2.7 System States.................................................................................................. 31
2.8 Application Methods ........................................................................................ 32
2.8.1 Ramp & Hold Method ................................................................................. 32
2.8.2 Pulses Method .......................................................................................... 34
2.8.3 Search Method.......................................................................................... 35
2.8.4 Limits Method ........................................................................................... 36
2.8.5 Levels Method .......................................................................................... 36
2.8.6 Thermal Sensory Limen (TSL) ..................................................................... 36
2.8.7 VAS Search Method ................................................................................... 36
2.8.8 Chain Method ........................................................................................... 37
3. System Components ................................................................... 38
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3.1 Main Power and Coolant Temperature Control panel ....................................... 38
3.2 Trolley Back Panel ........................................................................................... 39
3.3 PATHWAY Electronic Box Front Panel .............................................................. 40
3.4 PATHWAY Electrical Box Back Panel (Internal) ............................................... 42
4. Setup and Installation ................................................................ 43
4.1 Computer Requirements .................................................................................. 43
4.2 Installation USB Content ................................................................................. 44
4.3 Setup and Installation Main Steps ................................................................... 44
4.4 Selecting a Location ........................................................................................ 44
4.5 Filling the System Coolant Reservoir ............................................................... 44
4.6 Device Connections ......................................................................................... 44
4.7 Software Installation ....................................................................................... 46
4.8 Unit Protection ................................................................................................ 47
4.9 Powering up the PATHWAY System ................................................................. 48
4.10 Product Activation ......................................................................................... 49
5. Operation ................................................................................... 50
5.1 Safety Procedures and System Self-Test ......................................................... 50
5.2 Starting PATHWAY........................................................................................... 50
5.3 Basic Operation ............................................................................................... 53
5.3.1 Menu Bar ................................................................................................. 54
5.3.2 Toolbar .................................................................................................... 55
5.3.3 Search Row .............................................................................................. 55
5.3.4 Current Selection Information ..................................................................... 55
5.3.5 Data Display Area ..................................................................................... 55
5.3.6 Status Line ............................................................................................... 55
6. Test Procedure and Management ............................................... 57
6.1 Selecting a Patient .......................................................................................... 58
6.2 Selecting a Program ........................................................................................ 59
6.3 Selecting a Body Site ....................................................................................... 60
6.4 Running the Test ............................................................................................. 61
6.4.1 Test and Post-Test Options ......................................................................... 63
6.4.2 Temperature Graph Display ........................................................................ 64
6.4.3 Test Run Keyboard Shortcuts (Hot Keys) ..................................................... 65
7. Program Management ................................................................ 66
7.1 Program List .................................................................................................... 66
7.2 Creating a New Program.................................................................................. 67
7.3 Remove a Program .......................................................................................... 68
7.4 Duplicate a Program ........................................................................................ 68
7.5 Edit a Program ................................................................................................. 68
7.6 Program Editor ................................................................................................ 69
7.6.1 Next Sequence Definition ........................................................................... 70
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7.7 Program Details ............................................................................................... 71
7.7.1 Ramp and Hold ......................................................................................... 71
7.7.2 Pulses ...................................................................................................... 74
7.7.3 Search ..................................................................................................... 76
7.7.4 Limits ...................................................................................................... 77
7.7.5 Levels ...................................................................................................... 78
7.7.6 Thermal Sensory Limen (TSL) ..................................................................... 81
7.7.7 VAS Search .............................................................................................. 82
7.7.8 Chain Program .......................................................................................... 84
7.8 Standard Events .............................................................................................. 85
7.8.1 TTL Setup ................................................................................................ 85
7.8.2 Standard Event Configuration ..................................................................... 85
7.8.3 List of Standard Events according to Program Type ....................................... 86
7.9 Temperature Events ........................................................................................ 87
7.9.1 Temperature Event Configuration ................................................................ 87
7.10 Test Instructions ........................................................................................... 88
7.11 Import / Export Programs ............................................................................. 89
7.11.1 Export Programs ....................................................................................... 89
7.11.2 Import Programs ....................................................................................... 90
7.11.3 Solving Conflicts When Importing Programs ................................................. 90
8. Patient Management .................................................................. 91
8.1 Patients List .................................................................................................... 91
8.2 Adding a New Patient ...................................................................................... 92
8.3 Remove a Patient ............................................................................................ 93
8.4 Edit Patient Details .......................................................................................... 93
8.5 Add \ Edit Departments ................................................................................... 94
8.6 Import / Export Patient Records ..................................................................... 94
8.6.1 Export Patient Records ............................................................................... 94
8.6.2 Import Patient Records .............................................................................. 95
8.6.3 Solving Conflicts When Importing Patient Records ......................................... 95
9. Results Management .................................................................. 96
9.1 Results List ...................................................................................................... 96
9.2 Import / Export Results .................................................................................. 97
9.2.1 Export Test Results ................................................................................... 98
9.2.2 Export Test Results to Excel ....................................................................... 98
9.2.3 Import Test Results ................................................................................... 99
9.2.4 Solving Conflicts When Importing Test Programs .......................................... 99
9.3 Generate Test Reports ..................................................................................... 99
9.3.1 Analysis Report Types ............................................................................... 100
9.3.2 Examples of Reports Types........................................................................ 102
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10. System Configuration ............................................................... 104
10.1 Software Settings ........................................................................................ 104
10.1.1 Communication ........................................................................................ 104
10.1.2 Report Options ........................................................................................ 105
10.1.3 Results Fields .......................................................................................... 109
10.1.4 Patient Fields ........................................................................................... 109
10.1.5 Button Configuration ................................................................................ 111
10.1.6 Users ...................................................................................................... 111
10.2 Hardware Settings ....................................................................................... 117
10.2.1 General Hardware Configurations ............................................................... 117
10.2.2 Safety .................................................................................................... 119
10.2.3 Thermode ............................................................................................... 119
10.2.4 CoVAS Calibration .................................................................................... 120
10.4 Test Settings ............................................................................................... 121
10.4.1 Test Configuration .................................................................................... 121
10.4.2 Event Marker ........................................................................................... 124
10.4.3 Event Sound Configuration ........................................................................ 125
10.4.4 Body Site Editor ....................................................................................... 126
10.4.5 4-Bit TTL Configuration ............................................................................. 127
10.4.6 Text and Audio Test Instructions ................................................................ 128
11. System Information and Logs .................................................. 130
11.1 View System Information ............................................................................ 130
11.2 Retrieve Full System Information ................................................................ 130
11.3 Customer Experience Improvement Program .............................................. 131
12. Appendix A – Normative Data ................................................... 133
12.1 Normative Data License Agreement............................................................. 133
12.2 Enable Normative Data ................................................................................ 134
12.3 Normative Data Editor ................................................................................. 135
12.4 Selecting Normative Data Source ................................................................ 137
12.5 Normative Data Display ............................................................................... 139
13. Appendix B – Cold Evoked Potentials........................................ 140
13.1 Overview ..................................................................................................... 140
13.2 Program Parameters ................................................................................... 140
14. Appendix C – External Control .................................................. 142
14.1 Overview ..................................................................................................... 142
14.2 Use Examples .............................................................................................. 142
14.2.1 Open Control Mode ................................................................................... 142
14.2.2 Closed Control Mode ................................................................................. 142
14.2.3 Typical Workflow ...................................................................................... 143
14.3 Parallel Communication ............................................................................... 144
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14.3.1 System Requirements ............................................................................... 144
14.3.2 Parallel Connector Configuration ................................................................ 144
14.4 Network Communication (TCP Sockets) ...................................................... 145
14.4.1 System Requirements ............................................................................... 145
14.4.2 TCP Socket Interface Overview .................................................................. 145
14.5 External Control Configuration .................................................................... 145
14.5.1 Setting Communication Method ................................................................. 145
14.5.2 Program Setup ........................................................................................ 146
14.5.3 Activating the External Control .................................................................. 146
14.5.4 Common Test Operations .......................................................................... 147
14.5.5 The External Control Workflow ................................................................... 147
14.5.6 Safe Mode ............................................................................................... 148
15. Appendix D – fMRI Conditional PATHWAY ................................ 149
15.1 PATHWAY system configuration in fMRI mode: ........................................... 149
15.2 Installation – CHEPS MR Filter ..................................................................... 151
16. Appendix E – FTP Support ........................................................ 154
16.1 Export Configuration ................................................................................... 154
16.1.1 Configure the FTP Upload Server ................................................................ 155
16.1.2 Automatic Export ..................................................................................... 155
17. Appendix F – Pain Rating .......................................................... 156
17.1 Pain Rating Parameters Configuration ......................................................... 156
18. Appendix G - Patient Record Control ........................................ 158
18.1 Control Patient Field Entry Format with Input Masks .................................. 158
18.1.1 Add/Remove Patient Fields ........................................................................ 159
19. Appendix H – Filling the System Cooling Unit Reservoir ........... 161
19.1 Approved Coolants ...................................................................................... 161
19.2 Coolant Filling ............................................................................................. 161
20. Appendix I – Accessories ......................................................... 165
20.1 System & Thermode Accessories ................................................................. 165
20.2 Service & Maintenance Accessories ............................................................. 167
20.3 MRI Conditional Accessories ........................................................................ 169
21. Appendix H – System and Module Description .......................... 171
22. Appendix J – Preventive and Periodical Maintenance ............... 172
22.1 Summary Maintenance Table ....................................................................... 172
22.2 Daily Preventative Maintenance Operations ................................................ 172
22.2.1 Visual Check ............................................................................................ 172
22.2.2 Flow Rate Check ...................................................................................... 172
22.3 Periodical System Run ................................................................................. 173
22.4 Thermode Calibration .................................................................................. 174
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22.5 Cooling Unit Maintenance ............................................................................ 174
22.6 Ground Conductivity Test (for fMRI system only) ........................................ 174
22.7 Periodical Thermode Maintenance ............................................................... 174
23. Appendix K – Cleaning and Disinfecting ................................... 175
24. Appendix L – List of Accompanying Documents ........................ 176
25. Appendix M – Transportation and Storage conditions .............. 177
26. Appendix N – Environmental Conditions ................................... 178
27. Appendix O – Troubleshooting ................................................. 179
27.1 Error and Warning Messages ....................................................................... 179
27.1.1 Frequent Warning Messages ...................................................................... 179
27.1.2 Frequent Error Messages ........................................................................... 181
27.2 Faulty System Responses ............................................................................ 189
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List of Figures
Figure 1: PATHWAY Label 110V ..................................................................................... 19
Figure 2: PATHWAY Label 230V ................................................................................ 19
Figure 3: Ramp &Hold Sequence – Return to Baseline ...................................................... 33
Figure 4: Ramp & Hold Sequence – Return to Next Destination ......................................... 34
Figure 5: Pulses Sequence – Without Low Destination ...................................................... 34
Figure 6: Pulses Sequence – With Low Destination .......................................................... 35
Figure 7: VAS Search – Manual Mode ............................................................................. 37
Figure 8: PATHWAY System Front View .......................................................................... 38
Figure 9: Main Power and Coolant Temperature Control panel ........................................... 38
Figure 10: System Back Panel ....................................................................................... 39
Figure 11: PATHWAY Electronic Box Front Panel .............................................................. 40
Figure 12: Electrical Box Back Panel .............................................................................. 42
Figure 13: Pathway Connection Diagram ........................................................................ 45
Figure 14: Trolley Electrical Connectors .......................................................................... 46
Figure 15: PATHWAY cart – back doors .......................................................................... 48
Figure 16: Communication port - COM ........................................................................... 48
Figure 17: Home screen product registration link............................................................. 49
Figure 18: Home Screen ............................................................................................... 51
Figure 19: Login Screen ............................................................................................... 51
Figure 20: PATHWAY Splash Screen ............................................................................... 51
Figure 21: Self-Test Prompt .......................................................................................... 52
Figure 22: PATHWAY in Rest Mode ................................................................................. 52
Figure 23: Test Navigator – Main Menu .......................................................................... 53
Figure 24: Test Management Main Screen ...................................................................... 57
Figure 25: Patient Selection Menu ................................................................................. 58
Figure 26: Program Selection Menu ............................................................................... 59
Figure 27: Body Site Selection Menu .............................................................................. 60
Figure 28: Select Body Site – Specific site selection ......................................................... 61
Figure 29: Pre-Test Screen ........................................................................................... 62
Figure 30: Real-Time Test ............................................................................................ 64
Figure 31: Program Management screen ........................................................................ 66
Figure 32: Program Management – Program Preview ....................................................... 67
Figure 33: New Program Screen .................................................................................... 68
Figure 34: Program Editor Screen .................................................................................. 69
Figure 35: Program Editor Next Sequence Definition ........................................................ 70
Figure 36: Manual Next Sequence Definition ................................................................... 71
Figure 37: Program Menu – Ramp and Hold .................................................................... 72
Figure 38: Program Menu – Pulses ................................................................................ 74
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Figure 39: Program Menu – Search ................................................................................ 76
Figure 40: Program Menu – Limits ................................................................................. 77
Figure 41: Program Menu – Levels................................................................................. 79
Figure 42: Program Menu – TSL .................................................................................... 81
Figure 43: VAS Search Program Editor ........................................................................... 82
Figure 44: Chain Program Editor ................................................................................... 84
Figure 45: Standard Events in Program Editor ................................................................. 85
Figure 46: Standard Event Editor .................................................................................. 86
Figure 47: Standard Event Configuration ........................................................................ 86
Figure 48: Temperature Events in Program Editor ........................................................... 87
Figure 49: Temperature Event Editor ............................................................................. 88
Figure 50: Test Instructions Editor ................................................................................. 88
Figure 51: Edit text instructions .................................................................................... 89
Figure 52: Replace audio instructions ............................................................................. 89
Figure 53: Patients List ................................................................................................ 91
Figure 54: Patient Management – Patient details preview ................................................. 92
Figure 55: Patients Editor Screen .................................................................................. 93
Figure 56: Edit Department Menu .................................................................................. 94
Figure 57: Results List ................................................................................................. 96
Figure 58: Result preview display .................................................................................. 97
Figure 59: Description sheet example ............................................................................ 98
Figure 60: Data sheet example ..................................................................................... 98
Figure 61: Analysis Reports Dialog ................................................................................ 99
Figure 62: Singles Report ............................................................................................ 102
Figure 63: Multiple Report ........................................................................................... 102
Figure 64: Site to Site Report ...................................................................................... 102
Figure 65: Pre / Post Report ........................................................................................ 102
Figure 66: Trend Report .............................................................................................. 103
Figure 67: Bilateral Report ........................................................................................... 103
Figure 68: Pain Rating Report ...................................................................................... 103
Figure 69: Custom Report ........................................................................................... 103
Figure 70: Open Software Settings ............................................................................... 104
Figure 71: Communication Tab .................................................................................... 104
Figure 72: Report Options Tab ..................................................................................... 105
Figure 74: Results Fields Tab ....................................................................................... 109
Figure 75: Patient Fields Configuration Screen ............................................................... 110
Figure 76: Buttons Configuration Tab ............................................................................ 111
Figure 77: User Authorization Software Settings ............................................................. 113
Figure 78: Open Hardware Settings .............................................................................. 117
Figure 79: General Tab ............................................................................................... 117
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Figure 80: Hardware settings – Safety tab ..................................................................... 119
Figure 81: Hardware settings – Thermode tab ................................................................ 119
Figure 82: Hardware Settings - CoVas calibration ........................................................... 120
Figure 83: Test Configuration Settings .......................................................................... 121
Figure 84: Event Marker .............................................................................................. 124
Figure 85: Event Sound Configuration ........................................................................... 125
Figure 86: Body Sites Editor ........................................................................................ 126
Figure 87: 4-Bit TTL Configuration ................................................................................ 127
Figure 88: Instructions Configuration ............................................................................ 128
Figure 89: Test Instructions Editor ................................................................................ 128
Figure 90:Audio save button ........................................................................................ 129
Figure 91: Sysinfo File Sample ..................................................................................... 130
Figure 92: MMS Home Screen ...................................................................................... 132
Figure 93: Normative Data Editor - Enable Normative Data.............................................. 134
Figure 94: Normative Data License Agreement ............................................................... 135
Figure 95: Normative Data Editor Screen ...................................................................... 136
Figure 96: Normative Data display in test screen ............................................................ 139
Figure 97: Normative Data Checkbox ............................................................................ 139
Figure 98: External Control Interface Open Control Loop Example .................................... 142
Figure 99: External Control Interface Closed Control Loop Example .................................. 143
Figure 100: External Control Workflow Example ............................................................. 143
Figure 101: Female Connector ..................................................................................... 144
Figure 102: Server Client Relationship .......................................................................... 145
Figure 103: External Control – Select Communication Method .......................................... 146
Figure 104: Activating External Control ......................................................................... 146
Figure 105: Listening mode ......................................................................................... 148
Figure 106: System Block Diagram ............................................................................... 151
Figure 107: fMRI CHEPS filter ...................................................................................... 152
Figure 108: CHEPS fMRI filter front view ....................................................................... 152
Figure 109: Open Software Settings ............................................................................. 154
Figure 110: Software settings export tab selection ......................................................... 154
Figure 111: Software Settings Export Tab...................................................................... 155
Figure 112: Pain Rating Parameters .............................................................................. 156
Figure 113: Pain Rating Limits ..................................................................................... 157
Figure 114: Patient Fields with Input Masks ................................................................... 159
Figure 115: Patient Card with Selected Patient Fields ...................................................... 160
Figure 116: Hose and funnel ........................................................................................ 161
Figure 117: ECU service door ....................................................................................... 161
Figure 118: Service Door is Open ................................................................................. 162
Figure 119: Connecting hose ....................................................................................... 162
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Figure 120: Adjusting hose into tap .............................................................................. 162
Figure 121: Holding the funnel up ................................................................................ 162
Figure 122: Open filling tap ......................................................................................... 163
Figure 123: Open funnel tap ........................................................................................ 163
Figure 124: Filling Coolant through funnel ..................................................................... 163
Figure 125: Coolant level gage ..................................................................................... 163
Figure 126: Closet he filling tap .................................................................................... 164
Figure 127: Close the funnel tap .................................................................................. 164
Figure 128: Disconnecting the hose .............................................................................. 164
Figure 129: System Diagram ....................................................................................... 171
Figure 130: Flow rate gauge ........................................................................................ 173
Figure 131: Error and Warning Messages Sample ........................................................... 179
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List of Tables
Table 1: Equipment Labels ........................................................................................... 19
Table 2: PATHWAY ATS Specifications ............................................................................ 25
Table 3: PATHWAY CHEPS Specifications ........................................................................ 25
Table 4: PATHWAY ATS and CHEPS Specifications ........................................................... 26
Table 5: Terminology ................................................................................................... 30
Table 6: PATHWAY Electronic Box Front Panel receptacles ................................................ 40
Table 7: PATHWAY Electrical Box Back Panel receptacles .................................................. 42
Table 8: Menu Bar options ............................................................................................ 54
Table 9: Status line parameters .................................................................................... 56
Table 10: Test Run options ........................................................................................... 63
Table 11: Hot Keys ...................................................................................................... 65
Table 12: Probe Type options ........................................................................................ 68
Table 13: Program Details ............................................................................................ 69
Table 14: Program Parameters ...................................................................................... 72
Table 15: Program Parameters ...................................................................................... 74
Table 16: Program Parameters ...................................................................................... 76
Table 17: Program Parameters ...................................................................................... 77
Table 18: Program Parameters ...................................................................................... 79
Table 19: Program Parameters ...................................................................................... 81
Table 20: Program Parameters ...................................................................................... 82
Table 21: List of standard events according to program type ............................................ 86
Table 22: Report Advanced Options .............................................................................. 100
Table 23: Built-in Report Templates .............................................................................. 100
Table 24: Patient Fields ............................................................................................... 110
Table 25: Authorization Parameters .............................................................................. 112
Table 26: Functions according to authorization level ....................................................... 113
Table 27: Pre-test parameters ..................................................................................... 122
Table 28: Test configuration parameters ....................................................................... 122
Table 29: Post-test parameters .................................................................................... 122
Table 30: Test Display configuration ............................................................................. 122
Table 31: Temperature Scale Configuration ................................................................... 123
Table 32: Temperature Limits ...................................................................................... 123
Table 33: Normative Data Fields .................................................................................. 136
Table 34: Program Parameters ..................................................................................... 140
Table 35: Action code description ................................................................................. 147
Table 36: Regular Characters ....................................................................................... 158
Table 37: Special Characters ....................................................................................... 158
Table 38: System & Thermode Accessories .................................................................... 165
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Table 39: Service& Maintenance Accessories .................................................................. 167
Table 40: MRI Conditional Accessories .......................................................................... 169
Table 41: Summarizing Maintenance Table .................................................................... 172
Table 42: Frequent Warning Messages .......................................................................... 179
Table 43: Frequent Error Message ................................................................................ 181
Table 44: Errors during calibration ................................................................................ 188
Table 45: Faulty System Responses .............................................................................. 189
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Warning: A condition that could cause serious injury or death to a patient
and/or operator if instructions are not followed.
Caution: A condition that could cause possible damage to equipment or
cause the system to function inaccurately.
Note: Indicates important user information regarding the use of the
system.
Advice: Refer to instruction manual/ booklet
INSTRUCTION: Indicates an instruction where it is important to follow the
user manual literally as described.
Disclaimer
Medoc assumes no liability for use of this document if any unauthorized changes to the
content or format have been made. Every care has been taken to ensure the accuracy of the
information in this document. However, Medoc assumes no responsibility or liability for
errors, inaccuracies, or omissions that may appear in this document. Medoc reserves the
right to change the product without further notice to improve reliability, function or design.
This manual is provided without warranty of any kind, implied or expressed, including, but
1. Safety Guidelines and Regulations
This manual is written for trained users of Medoc Products. The user includes the body with
authority over the equipment and those persons who actually handle the equipment.
Before attempting to work with this equipment, read, understand, note and strictly observe all
Warning notices, Cautions and Safety markings on the equipment.
Before attempting to work with this equipment, make sure that this manual and any Release
Notes delivered with the software media pack have been thoroughly read and fully understood,
paying particular attention to all:
1. Warnings
2. Cautions
3. Notes
4. Important Notices
5. User Notices
1.1 User Manual Icons
The following icons are used throughout the user manual:
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The PATHWAY system can be tested according to IEC 62353 Recurrent test
and test after repair of medical electrical equipment.
Do not modify or replace any component of the PATHWAY system.
Connecting or replacing external PATHWAY accessories is allowed.
Keep all liquids away from the PATHWAY system.
Unplug the PATHWAY system if it is not to be used for a long period of time.
Do not block airflow anywhere around the PATHWAY system.
1.2 Intended Use
The use of the Pathway system should be as intended by Medoc Ltd. and as specified in the
user manual. The PATHWAY is a pain management and pain research system intended to be
used for the quantitative assessment of small nerve fiber dysfunctions. It measures sensory
thresholds such as cold and warm sensation and heat-induced pain.
1.3 Safety and Regulatory Summary
Read and follow all WARNINGS, CAUTIONS and NOTES provided in this manual. To avoid the
possibility of injury, damage to your system, or loss of data, always follow these precautions
during system operation.
The PATHWAY system complies with safety requirements for medical electrical
systems (based on the IEC 60601-1 standard).
The PATHWAY system complies with electromagnetic emission levels (based on table
201 in the IEC 60601-1-2 standard).
The PATHWAY system complies with electromagnetic immunity levels (based on
tables 202 and 204 in the IEC 60601-1-2 standard).
This device complies with 93/42/EEC MDD.
It is recommend keeping a distance of 3 meters between portable and mobile RF
communications equipment and the PATHWAY (based on table 206 in the IEC 606011-2 standard).
1.4 Safety Requirements
1.4.1 Warnings
To avoid the risk of electric shock, this equipment must only be connected to a
supply mains with protective earth
Only personnel properly trained to operate the PATHWAY system should use this
system.
Do not turn on system power until all cables have been properly connected and
verified.
Do not use any electrode paste, gel, or other material on the contact point between
the Thermode plate and the skin of the tested subject.
Test Subject must be trained to use the panic button before performing any test with
the PATHWAY system in order to prevent damage.
Test subject must hold the PATHWAY panic button throughout the entire duration of
the test.
Using the PATHWAY system with the panic button disconnected is not allowed.
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To reduce the risk of injury, attach the Thermode to the subject only prior to running
a test while MEDOC Main Station is in Test screen. Remove the Thermode from the
subject skin before leaving the Test Screen.
Connect the Thermode to the patient’s skin ONLY during the test; not during system
Self-Test, programming or maintenance.
To reduce the risk of injury while working in MR environment, follow the safety
instructions as presented in section 14, page 142
The computer that is used to operate the PATHWAY system must be connected to
the PATHWAY power outlet or to a Medical Grade Isolation Transformer only.
The computer that is used to operate the PATHWAY system must never be connected
to a network while it is used for running tests.
The use of accessories or cables other than those specified, with the exception of
accessories or cables sold by the manufacturer as replacement parts, may result in
increased emissions or decreased electrical immunity of the device.
Connecting any device or accessory that has no medical grade certificate to the
PATHWAY system is not allowed.
Using a Thermode without the appropriate calibration table may result in potential
harm or injury.
Using the PATHWAY system not according to instructions may result in potential
harm or injury.
fMRI Thermodes should be used ONLY in fMRI scanners. Outside the fMRI scanner
use only the Standard Thermodes. Using fMRI Thermodes outside of the scanner
may result in damage to the fMRI Thermode or PATHWAY system.
Adverse Reaction: Skin irritation (in addition to pain sensation) beneath the probes
has been reported with the use of a stimulator, which was based on similar
technology as the PATHWAY device.
Be aware of potential risk of skin damage caused by wrong parameter combination.
Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are
operating normally.
Use of accessories, transducers and cables other than those specified or provided by
the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the Pathway, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
NOTE The EMISSIONS characteristics of this equipment make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this equipment might
not offer adequate protection to radio-frequency communication services. The user
might need to take mitigation measures, such as relocating or re-orienting the
equipment
1.4.2 Cautions
Proper use of this device depends on careful reading of all instructions and labels.
Turn OFF system power before connecting or disconnecting any system
component(s) or accessories. Otherwise, you may damage the device(s).
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The Thermode is very delicate and can easily be damaged. Therefore, handle with
care.
If you disconnect any cables, take care to reconnect them correctly to prevent
damage to the system or components.
This equipment uses a three-wire power cord with a hospital grade plug (for non-
USA applications, the IEC 60601-1-approved plug).
Inspect the power cord often for fraying or other damage. DO NOT operate the
apparatus if the power cord or plug is damaged.
Portable and mobile RF communications equipment can affect medical electrical
equipment.
Use caution when using the PATHWAY Thermode on patients with suspected
neuropathies as they may be more susceptible to soft tissue or nerve damage at
extreme temperatures. Also, patients with neuropathies may not be able to properly
discontinue use of the device during prolonged hot or cold stimulation.
Test Subject should be trained to use the response unit before performing any test
with the PATHWAY system.
Use of a stimulator, which was based on similar technology as the PATHWAY device,
in evaluating the functionality of human pain reception and transmission of sensory
pathways at 6°C has been reported to have comparable outcomes in assessment of
pain reception and sensory pathways to 0°C.
1.4.3 Equipment Classification
Degree of protection against electric shock: Class I
Type of protection against electric shock: BF
Type of Operation: Continuous
Protection against ingress of liquids: Not protected against ingress of liquids
Ordinary equipment
Computer must comply with IEC 950 - EN 60950 - UL 60950.
1.5 System Protection
1.5.1 System Self-Test
Upon start-up the system performs a self-test in which system sensors are being tested. If a
malfunction is detected, an appropriate message is displayed and the system cannot operate
until that malfunction is resolved.
1.5.2 Temperature Safety Mechanisms
Several safeguard mechanisms have been implemented in the system to safeguard against
extreme temperatures and to protect the tested subject and the unit.
Software protection mechanisms include:
Temperature upper and lower limits – In normal operation, Thermode temperature
will always be within these limits.
Time duration limits – Thermode temperature is limited in duration. If the Thermode
temperature maintains a specific temperature (or above) for a longer period of time
then specified for that temperature, the system will go into Safe Mode.
Safe Mode – a protective state of the system in which it is not possible to run tests.
In any case of suspected malfunction or if any modification is made to system
hardware settings, system will remain in safe mode until a system Self-Test is
performed.
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Figure 1: PATHWAY Label 110V
Figure 2: PATHWAY Label 230V
Equipment Label
Description
I
O
Power switch ON/OFF
COM
Communications connector.
Date of Manufacture (YYYY-MM)
Manufacturer
Degree of protection against electric shock – Applied Part
Type BF.
Warning - Connect the power cord to the power outlet,
according to the local electrical standards.
Refer to Manual
Hardware protection mechanisms include:
If the Thermode temperature reaches 57C an analog circuit overrides the system and
lowers the temperature gradually.
1.5.3 Thermode Detection
The system automatically detects that a Thermode is missing, and disables it in order to
protect both system and user.
1.6 Equipment Labels, Symbols, Warning Statements and
Abbreviations
Table 1: Equipment Labels
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Disposal according to electronic scrap ordinance
Manual edition refers to current version of manufactured system
Medoc reserves the right to change specifications without prior notice, in
line with the company policy of constant product improvement
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Declaration – electromagnetic immunity
IMMUNITY test
IEC 60601 test
level
Compliance
level
Electromagnetic
environment –
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
8 kV contact
2, 4, 8, 15kV air
8 kV contact
2, 4, 8, 15kV
air
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be
at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
2 kV for power
supply lines
1 kV for
input/output lines
2 kV for
power supply
lines
1 kV for
input/output
lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
1 kV line(s) to
line(s)
2 kV line(s) to earth
2 kV Signal
input/output) to
earth
1 kV line(s) to
line(s)
2 kV line(s) to
earth
2 kV Signal
input/output)
to earth
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines
IEC 61000-4-11
0% UT; 0.5cycle at
0°, 45°, 90°,
135°,180°, 225°,
270° and 315°
0% UT; 1cycle and
70% UT; 25/30
cycles
Single phase at 0°
0% UT; 250/300
cycle
0% UT;
0.5cycle at
0°, 45°, 90°,
135°,180°,
225°, 270°
and 315°
0% UT;
1cycle and
70% UT;
25/30 cycles
Single phase
at 0° 0% UT;
250/300 cycle
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the Pathway requires
continued operation during
power mains interruptions, it is
recommended that the Pathway
be powered from an
uninterruptible power supply or
a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 (A/m)
30 (A/m)
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of
the test level.
1.7 Electromagnetic Immunity
The PATHWAY is intended for use in the electromagnetic environment specified below. The
customer or the user of the PATHWAY should assure that it is used in such an environment.
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Declaration – electromagnetic emissions
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions CISPR
11
Group1 Class
A
The Pathway uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.
Harmonic emissions
IEC
61000-3-2
Class A
The Pathway is suitable for use in all
establishments other than domestic, and may be
used in domestic establishments and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes, provided the
following warning is heeded: Warning: This
equipment/system is intended for use by
healthcare professionals only. This equipment/
system may cause radio interference or may
disrupt the operation of nearby equipment. It
may be necessary to take mitigation measures,
such as re-orienting or relocating the Pathway or
shielding the location.
Voltage Fluctuations
And Flicker
IEC 61000-3-3:2013
Complies
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3V, 6V
3V/m
3Vrms, 6V
3V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the PATHWAY, including cables, than
the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey*
should be less than the compliance level in
each frequency range**
Interference may occur in the vicinity of
equipment marked with the following symbol:
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3V from
0.15 to
80MHz;
6V from
0.15 to
80MHz and
80% AM
at 1kHz
10V/m
from
80MHz
to 2.7GHz
3V from
0.15 to
80MHz;
6V from
0.15 to
80MHz and
80% AM
at 1kHz
10V/m from
80MHz
to 2.7GHz
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
* Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed
RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the PATHWAY is used exceeds the applicable RF compliance
level above, the PATHWAY should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or
relocating the PATHWAY.
** Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
1.7.1 Essential Performance
In the case of electromagnetic disturbances, the system will attempt to maintain
communication with the MMS software and enable the continuity of the test. If the disturbance
does cause communication failure with the PC or affects the system microcontroller, safety
mechanisms are activated automatically and the thermode will be disconnected. An error
message will pop up indicating system communication has been lost (see Appendix O –
Troubleshooting) and a buzzer will sound. Remove the thermode from the patient and follow
the SW instructions to restore communication and perform the self-test.
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Rated
maximum
output
power of
transmitter
W
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
outside ISM
bands
150 kHz to 80 MHz
in ISM bands
80 MHz to 800 MHz
800 MHz to 2,5 GHz
0.01
0.12
0.2
0.4
1
0.1
0.37
0.64
1.3
2.6
1
1.17
2 4 8
10
3.7
6.4
13
26
100
11.7
20
40
80
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be estimated using the equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
1.8 Recommended Separation Distance between Portable and
Mobile RF Communications Equipment and PATHWAY
The PATHWAY is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the PATHWAY can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the PATHWAY as recommended below,
according to the maximum output power of the communications equipment.
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Medoc reserves the right to change specifications without prior notice, in
line with the company policy of constant product improvement
Some of the specifications require specific license / hardware which are
not available in the standard configuration.
Parameter
Description
ATS Thermode (probe)
active area
30 mm × 30 mm (standard)
16 mm × 16 mm (small)
Thermode temperature
range
0 – 55°C (Optional -10 °C to 55 °C)
Baseline thermode
temperature
10 – 45°C, programmable
Rate of temperature change
- Linear mode
0.1 – 8 °C/sec (Range may be lower depending on protocol
used). Note: Rate may vary within ±10%
Parameter
Description
CHEPS Thermode (probe)
active area
27 mm diameter
Thermode temperature
range
30 – 55°C (Optional 20 – 55°C)
Baseline thermode
temperature
30 – 45°C, programmable
Temperature change rate
Increase rate 0.1 – 70°C/sec
Decrease rate 0.1 – 40°C/sec
Range may vary depending on protocol used. Note: Rate
may vary within ±10%
1.8 Technical Data
The table below describes the technical specifications and capabilities of the Pathway system.
When stated, the term 'Optional' indicates that this specific feature requires an additional
license and/or hardware component.
1.8.1 PATHWAY – ATS model only
Table 2: PATHWAY ATS Specifications
1.8.2 PATHWAY – CHEPS model only
Table 3: PATHWAY CHEPS Specifications
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Parameter
Description
Stimuli protocols
Pulses
Ramp and Hold
Search
Limits
Levels
TSL
Chain
Stimulus duration at
destination temperature
0 – 600 Sec (limited by safety cut-off. See below)
Inter-sequence time interval
(Time interval between
sequences)
0 – 600 Sec., in 0.1 Sec. resolution
Intra-sequence time interval
(Time interval between
stimuli, in one sequence)
0 – 600 Sec., counted onset-to-onset or end-to-onset, in 0.1
Sec. resolution.
Optionally, this interval can be randomized within a
predetermined range.
Randomize Option
Option to randomize between sequences
Number of stimuli in a
program
Each sequence can include up to 100 trials (stimuli). The
number of sequences in a program can be more than 100.
Stimuli trigger options
Automatic
Manual using designated push button or keyboard
External, via a TTL input
Synchronization options
TTL Input
Externally trigger the onset of stimulus
Voltage: ± 5V
Current: 10 – 15 mA
Minimum Duration: 10 msec.
Synchronization options
TTL Output
Can indicate various events during stimuli (depending on
protocol used)
Voltage: ± 5V
Current: 2 mA
Duration: 50 – 1000 msec
Auxiliary TTL output option
TTL output on a predetermined delay after onset. Delay is
programmable. Duration of TTL output is programmable in
the range of 50 to 600 milliseconds. Other characteristics
are same as for TTL Out.
1.8.3 PATHWAY ATS and CHEPS models
Table 4: PATHWAY ATS and CHEPS Specifications
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Parameter
Description
Sound option (Computer
speakers are required – not
supplied)
Can indicate various events during stimuli (depending on
protocol used)
CoVAS (Optional)
Computerized Visual Analog Scale (CoVAS) enables real-
time recording of the subject’s pain level, according to the
standard VAS procedure.
MRI Configuration (Optional)
Special accessories and Thermode which can be used in an
MR environment (for specification refer to section 14)
fMRI Thermode and accessories cable length: 10m
fMRI filter body diameter: 70mm
fMRI filter cable length: 2m
External Control(Optional)
Optional control mode, which enables programs to be
initiated from an external application or device. External
Control can be established via Parallel Port or using TCP/IP
network.
Temperature set-point
resolution
0.1°C
Temperature display
resolution
0.1°C
Temperature repeatability
± 0.1°C
Absolute accuracy
± 0.3°C
Ambient temperature in
standard use
18 - 24°C
Communication with
computer
USB
Communication with printer
Via the computer
Computer Requirements
See Separate specifications
Software Operating System
Windows 7, 8, 10 (32/64 bit)
Database
SQL Server Compact Edition (included with software)
Software Language
English
Database capacity
Unrestricted (limited by computer hardware capabilities)
Safety
Complies with UL-2601-1:94 and EN-60601-1-1
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Parameter
Description
Safety limitations on
Temperature & Duration
(1) 56 °C during 0 sec.
(2) 55 °C during 0.05 sec.
(3) 52 °C during 0.4 sec.
(4) 51 °C during 1 sec.
(5) 50 °C during 5 sec.
(6) 49 °C during 10 sec.
(7) 47 °C during 60 sec.
(8) 6 °C during 5min.
(9) 0 °C during 5min.
(10) -10 °C during 5min.
System Configuration
Mobile cart configuration, including electronic box, heavyduty External Cooling Unit and 1 KW medical grade isolation
transformer model ISB-100W. (Not including notebook
laptop and printer)
Dimensions
(Mobile cart configuration)
103 × 52 ×61 cm
Weight
(Not including computer)
90-100 Kg (depending on Thermode type)
Operation Voltage
100-120VAC, 60Hz, 4A.
220-240VAC, 50Hz, 2A.
(Via a switchable isolation transformer)
System Overload Protection
2 X 250V, 5A Slo-Blo (for 230V Isolation Transformers).
2 X 120V, 10A Slo-Blo (for 110V Isolation Transformers).
Electronic Box Overload
Protection
2 X 250V, 2A Slo-Blo (for 230V).
2 X 120V, 4A Slo-Blo (for 110V).
Product life time
10 Years
Thermode life time
2 Years
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2. Overview
The PATHWAY Pain & Sensory Evaluation System is an advanced, computerized thermal
stimulator designed for advanced neurological and pain research. The PATHWAY System is
available in six main configurations, as it is a completely modular system with easy upgrade
capabilities. The PATHWAY system offers a specially designed software program, which can be
integrated with research programs such as “LabView” and “MatLab”, for controlling PATHWAY
stimulation protocols. PATHWAY system also allows synchronization with external devices such
as fMRI and EEG systems.
The PATHWAY system uses two types of active devices named Thermodes: a CHEPS (Contact
Heat Evoked Potential) Thermode and an ATS (Advanced Thermal Stimulator) Thermode.
These devices are attached to the skin of the tested subject for stimulation delivery. Both
Thermodes include the following components:
Thermistors: Components that sense changes in temperature and send feedback to
the control unit. In response to the required temperature parameter, the
temperature control unit commands the heating or cooling of the Thermode.
Peltier elements: Components that consist of semiconductor junctions, which
produce a temperature gradient between the upper and lower stimulator surfaces
produced by the passage of an electric current. The Peltier element emanates heat
from its upper surface, produced by the external foil. The lower surface of the Peltier
element is cooled by a coolant that circulates via flexible tubes to the External
Cooling Unit.
The unique characteristics of each of the two Thermode types are brought in details
hereunder:
2.1 CHEPS Thermode
The CHEPS (Contact Heat Evoked Potentials)Thermode is comprised of two layers of
stimulators working together:
o An external layer, which consists of a heating foil that has two thermocouples
(electronic thermal sensors).
o A lower layer, which is a Peltier element with one thermistor (electronic thermal
sensors), and one water thermistor.
The CHEPS Thermode external foil is isolated from the skin of the subject by an
electrically isolated plastic layer (Kapton®).
The CHEPS Thermode can reach a very rapid heating rate of 70C/Sec. This effect is
enabled by the external foil.
The CHEPS Thermode Achieves a rapid cooling rate of up to 40C/Sec, which is
enabled by the Peltier element.
Sophisticated hardware and software control the counter balance or thermal (heat/
cool) integration at a rate of 200 times per second.
The round activation area of the contact Thermode is 573 mm2 (27 mm in diameter).
Stimulation temperature range is 30C to 55C. Stimulation range can be widened,
by installing the Cold EP patch. See section 13 page 140.
2.2 ATS Thermode
The ATS (Advanced Thermal Stimulator) Thermode is comprised of one stimulator
layer, which is constructed of a Peltier element with two thermistors (electronic
thermal sensors) and one water thermistor. The Surface contacting skin of subjects
is aluminum coated, for the purpose of heat dispersion.
This device is capable of delivering heat or cold stimulations.
The heating-up rate can reach 8C/Sec.
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Refer to section 20, page 165 to view the full range of Thermode types and
sizes.
Term
Description
Thermode
The probe which is used to apply the thermal stimulation on the subject's
skin.
TEC
Thermo Electric Cooler (TEC), a Peltier element used as the active heat
generator in the Thermode.
Heater
The active heat generator used for the CHEPS Thermode.
Cooling Unit
The Cooling Unit (referred to also as an External Cooling Unit – ECU) is a
component within the system which is responsible for refrigerating and
circulating the coolant through the system and Thermode(s).
Rest Temperature
The initial/rest temperature of the Thermode, after system initialization
and in between tests. Also referred to as Adaptation Temperature.
Baseline
Temperature
The initial temperature the stimulus starts from
Destination
Temperature
The final temperature the stimulus ends with.
Duration Time
Indicates the time the probe will remain at the destination
Pulse
A short and fast stimulus specified by the baseline and destination
temperatures only. The rate is automatically set to the maximum
capability.
Trial
Represents one stimulus
Sequence
A set of trials with the same specifications
Test
A set of sequences.
The square activation area of the contact Thermode is 900 mm2 (30 mm side).
Stimulation temperature range is 0C to 55C.
2.3 Switching Thermodes
The software activates the proper Thermode, based on the Program chosen by the user.
No additional user intervention is required. To disable or disconnect a Thermode refer to the
Technical service manual for detailed instructions.
2.4 Available Configurations
There are six available configurations, and one can upgrade to any one of them:
CHEPS model.
fMRI CHEPS model.
ATS model.
fMRI ATS model.
ATS – CHEPS model.
fMRI ATS – CHEPS model.
2.5 Terminology
The following terms are used throughout the user manual:
Table 5: Terminology
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Term
Description
TTL
An output or input, short and square signal which is commonly used to
synchronize between different devices.
Event
A specific occurrence during a test such as the onset of a stimulus,
reaching a specific temperature and etc.
LUT
A Look Up Table (LUT) maps one set of values to another. A LUT is used
to map between the readings from the temperature sensors to the actual
temperature it represents.
Emergency Button
The Emergency (or Panic) button is used to stop the stimulation in case of
an emergency or any irregular system behavior during a test.
Firmware
The program embedded on the internal processor of the system
2.6 System Status
Online: This is the PATHWAY system full operating mode and indicates full
communication between MEDOC Main Station and Pathway System. While on-line
the PATHWAY system can operate in several different states as listed in the following
section.
Simulator: The system is operating in demo mode. There is no communication
between the software and the PATHWAY system. All tests performed while working
in this mode are simulated. No actual thermal stimulation is performed and there is
no access to the PATHWAY hardware settings. The Simulator is useful for
demonstration, training and for protocol design without executing actual thermal
stimulation. It is recommended to turn off the PATHWAY system while working in
Simulator mode.
2.7 System States
System State is the active state in which the system is currently operating. System states
refer to the online status only.
The PATHWAY active states are as follows:
Rest Mode: The PATHWAY system is active and ready to perform a test. The
temperature is maintained at the specified Rest Mode temperature (programmable).
The default value (after anew installation) is 32°C. In this mode patient, program
and result management are possible.
Test Run: The PATHWAY system is running a (predefined) test. The Thermode is
active, and the temperature varies according to the active program.
Safe Mode: No power output is delivered to the Thermode and no test can be
activated. The system must perform a Self-Test before resuming normal operation.
Engineering: During Thermode Calibration the system state is set to Engineering
Mode. In this state safety limitations are lowered and running any actual test is not
allowed.
Test Initiation: The system raises the temperature from Rest Mode temperature to
Baseline level. A stabilization test is then performed, to make sure that the
temperature is maintained according to the program requirements.
Self-Test: The system performs a Self-Test in order to check whether the connected
Thermodes function according to system requirements.
Black Box: The system has detected an error and is currently logging data in the
internal memory. The log file can be exported later for service use.
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Before using each of these methods, make sure you have read section 6,
Page 57, on Test Procedure and Management, which addresses the
following topics: Test subject selection, Program selection, and Stimuli
administration.
2.8 Application Methods
The Method defines the type of protocol used for the test. The following methods are
supported (both in the CHEPS and ATS models):
Ramp & Hold: The temperature of the stimulus is maintained for a predetermined
duration.
VAS Search: A set of Ramp & Hold stimuli is emitted, and for each stimulus, the
subject is required to report the perceived level of pain. The following stimulus is
calculated according to the subject's response.
Pulses: Fast and short duration stimuli.
Search: The temperature of the stimulus rises (or falls) according to the tested
subject’s response (using CoVAS or Response Unit), and stops after a predefined
period.
Limits: A set of stimuli at a predetermined rate is given, and for each stimulus, the
subject is required to stop the stimulus when perceiving the required sensation.
Levels: A set of stimuli is emitted, and for each stimulus, the test subject is required
to respond. The following stimulus is calculated according to the tested subject's
response.
Thermal Sensory Limen (TSL): The temperature of the stimulus rises (or falls)
according to the test subject's response and stops according to predefined trails.
VAS Search: A set of Ramp & Hold stimuli is emitted, and for each stimulus, the
subject is required to report the perceived level of pain. The following stimulus is
calculated according to the subject's response.
Chain: This method can chain any of the predefined methods, any number of times,
in any order.
2.8.1 Ramp & Hold Method
In this method, the temperature rises (or falls) to a predetermined destination, at a
predetermined rate, remains there for a predetermined duration and proceeds to the next
destination.
There are two main options: Return to Baseline, and Continue to Next Destination.
2.8.1.1 “Return to Baseline” option
The diagram below shows a general view of the sequence and predefined parameters. For the
definition of each parameter, see7.7.1, page 71.
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Temperature
Time
Baseline
Temperature
Destination
temperature
Onset
Destination
Temperature
End of
Duration
Duration
Time
Time
Before
Sequence
Onset-to-Onset Time
Trial 1
Trial 2
End-to-Onset
Time
Sequence 1
Start Test
End Test
Figure 3: Ramp &Hold Sequence – Return to Baseline
Each sequence consists of a number of similar trials (one trial is also allowed).
1. The start point of each trial is called onset.
The temperature at this point (the onset point) is the Baseline Temperature defined for this
sequence.
2. From this point the temperature changes at a predefined rate, until it reaches the
predefined Destination Temperature.
3. Then, the temperature remains at the destination temperature level for the predefined
duration time. The point at the end of the duration time is called end of duration.
Setting duration time to zero produces peaks.
4. Finally, the temperature returns at the return rate, to the baseline temperature. The
temperature remains at this level for a duration that can be specified in one of two ways:
as an end-to-onset time or an onset-to-onset time.
At the start of each sequence the temperature should remain at the Baseline Temperature
level for the time given by the parameter Time Before Sequence.
2.8.1.2 “Return to the Next Destination” option
The temperature at the End of Duration point goes directly to the Destination Temperature of
the next sequence when this option is used.
This is available only for sequences consisting of one trial.
See definition of each parameter in section 7.7.1, page 71.
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Temperature
Time
Destination
Temperature 1
Sequence 1
Sequence 2
Destination
Temperature 2
Onset
Temperature
Time
High Destination
Temperature 1
Sequence 1
Sequence 2
Trial 1
Trial 2
Time
Before
Sequence
High Destination
Temperature 2
Baseline
Temperature
Onset
Inter
Stimuli
Interval
Peak
Start Test
End Test
Figure 4: Ramp & Hold Sequence – Return to Next Destination
2.8.2 Pulses Method
When using this method, the temperature rises or falls at a very fast rate, and then returns to
a predefined starting point of a new pulse.
There are two main options: Without a Low Destination, or With a Low Destination.
2.8.2.1 Without a Low Destination
The schema below shows a pulses sequence without a low destination.
Figure 5: Pulses Sequence – Without Low Destination
Each sequence consists of a number of similar trials (one trial is also allowed).
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1. The starting point for each trial is called the Onset.
The temperature at this point is the Baseline Temperature defined for the entire sequence.
2. From this point on the Baseline Temperature is maintained until the pulse is created. The
temperature at the peak of a pulse is the High Destination Temperature.
3. When the High Destination Temperature is reached, the temperature returns to the
Baseline Temperature.
4. From here on the Baseline Temperature is maintained until the next pulse is created.
At the start of each sequence the temperature should remain at the Baseline Temperature for
the time given by the parameter Time Before Sequence.
See section 7.7.2, page 74, for full description of program details and parameters.
2.8.2.2 With a Low Destination
When this option is used, the first pulse in each trial starts at the Baseline Temperature and
ends at the Low Destination Temperature. All the following pulses start and end at the Low
Destination Temperature. The last pulse in the trial starts at the Low Destination Temperature
and ends at the Baseline Temperature.
Figure 6: Pulses Sequence – With Low Destination
2.8.3 Search Method
The Search method allows you to map the test subject for pain / sensory threshold.
The Search sequence may start with a defined baseline temperature, or with a ramp from the
Baseline Temperature to other destination temperatures. After the temperature has stabilized
on the Baseline Temperature (in the first case), or reaches the Destination Temperature (in
the second case), the test subject starts to control the temperature changes, by using one of
the following input devices:
Response unit – Pressing No decreases temperature .Pressing Yes increases the
temperature. The temperature increase and decrease rates are parameters of the
sequence. Temperature safety limits are controlled during the test using standard
PATHWAY safety procedures.
COVAS – The user controls direction and rate of temperature change.
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The test subject controls the temperature changes during the time defined for this sequence,
after which the temperature returns to the Baseline Temperature.
See section7.7.3, page 76, for full description of program details and parameters.
2.8.4 Limits Method
This reaction time inclusive method consists of a string of stimuli of continuously changing
intensity. With each stimulus, when the subject perceives a predefined sensation, he/she
manually stops the stimulus.
The Limits method is the most widely used method for threshold determination, because it
requires the shortest test procedure of all methods, and it can measure not only pain
thresholds, but also non-painful thermal thresholds.
See section 7.7.4, page 77 for full description of program details and parameters.
2.8.5 Levels Method
In the Levels method, stimuli are increased by a predetermined initial step until the first YES
response. Stimuli are then decreased by one half the initial step until a NO is given.
Subsequently, the direction changes according to the response: increase for NO and decrease
for YES. The step size is halved at every direction change. The test is terminated when the
step reaches a small enough size, as pre-determined by the user. The threshold is determined
by taking the mean of the last YES and the last NO.
A modified version of the Levels method allows you to hold the temperature for a predefined
period at the destination value. See section7.7.5, page 78 for full description of program
details and parameters.
2.8.6 Thermal Sensory Limen (TSL)
Another reaction time dependent method is the detection of the Thermal Sensory Limen
(TSL).
In this algorithm, once started, the stimulus temperature does not stop at Baseline but
continues directly from the warm threshold to the cold threshold and vice versa. After several
oscillations between warm and cold sensory thresholds, the ‘Limen’ of no thermal sensation is
calculated as the difference between means of cold-sensation and warm-sensation. Using the
TSL method, allows for the Limen or ‘no thermal sensation’ area to be calculated.
See section7.7.6, page 81 for full description of program details and parameters.
2.8.7 VAS Search Method
In VAS Search method, first Ramp & Hold stimulus with predefined intensity and duration is
given and the subject is asked to estimate the perceived magnitude of pain. The intensity of
the next stimulus is set according to the response – increases if the reported pain rating is
lower than the desired, decreases if the reported pain rating is higher than the desired. The
step size by which the intensity of the next stimulus is changed can be predetermined during
program creation or set by the operator during the test. The VAS Search method can be used
to individually define what temperature is associated with patient's pain rating.
The temperature associated with the subject individualized rating of pain can be determined in
one of two modes – automatic and manual.
In Manual mode only the first stimulus is predefined, the intensity of the next stimulus is set
by the operator during the program run using the following window that pops up after each
trial:
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Figure 7: VAS Search – Manual Mode
In this window the user selects if to increase or decrease the destination temperature of the
next trial and by how much (determined by the 'Step Size' value). There is also an option to
resume the program if the operator decides that the target pain rating was reached.
In Automatic mode the target pain rating and the step size are predetermined during program
creation and the temperature of each trial is defined according to these parameters and the
subject reported pain rating - increases by the step size value if the reported pain rating is
lower than the target and decreases by the step size value if the reported pain rating is higher
than the target.
See section 7.7.7, page 82 for full description of program details and parameters.
2.8.8 Chain Method
Using this method, you can create a program that includes any other methods, any number of
times, in any order.
See section 7.7.8, page 84 for full description of program details and parameters.
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Mouse Tray
Thermode
Storage
Main Power
and Cooling
Monitor
PATHWAY
Control Unit
Internal
Components:
Cooling Unit
and Isolation
Transformer
Coolant
Temperature
Control Panel
Main Power
Switch
3. System Components
Figure 8: PATHWAY System Front View
3.1 Main Power and Coolant Temperature Control panel
Figure 9: Main Power and Coolant Temperature Control panel
The system power and coolant temperature control panel contains the following controls:
Coolant temperature control panel – electronic thermostat for external cooling unit.
For additional instructions, refer to accompanying documentation.
Main Power switch – PATHWAY system main power switch.
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Do not connect any equipment to the service connectors during test
subject examination.
Communication and Service
Ports Door
Electrical box Panel and
Fuses Maintenance Access
Door
Cooling Unit Maintenance
Door
Power Inlet and Outlet
3.2 Trolley Back Panel
The back panel offers of the following access:
Communication and service ports door
o Communication port
o JTAG port
o Service Cable port for 4-bit TTL and analog output
o ECU control
Electrical Box Panel and Fuses Maintenance access door
Power Inlet and Outlet
Coolant reservoir access door
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Figure 10: System Back Panel
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#
Description
Mate with
1
CHEPS Thermode Main receptacle
2
CHEPS Thermode sensors receptacles
3
CHEPS Thermode coolant receptacles
4
ATS Thermode Main receptacle
5
ATS Thermode coolant receptacles
6
TTL IN receptacle
Use for synchronization with external device
Standard coaxial cable with BNC
connector
7
TTL OUT receptacle
Use for synchronization with external device
Standard coaxial cable with BNC
connector
8
TTL AUX receptacle
Use for synchronization with external device
Standard coaxial cable with BNC
connector
1
2
3
4
5
1 2 3 4 5
6
7
8 9 111
1
3.3 PATHWAY Electronic Box Front Panel
Figure 11: PATHWAY Electronic Box Front Panel
PATHWAY Electrical box front panel contains the following receptacles and controls:
Table 6: PATHWAY Electronic Box Front Panel receptacles
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#
Description
Mate with
9
Response Unit receptacle
Use for recording patient response during test
10
CoVAS receptacle
Use for recording patient visual analog scale
during test
11
Manual Trigger receptacle
Enable to start tests manually by the system
operator
12
Emergency stop button (Panic button)
Pressing this button during a test in the event
of an emergency enables the operator to
immediately abort the test. After releasing the
pressed Emergency button, the PATHWAY
system will run a self test. A self test is run
automatically after any kind of safety violation
To release the Emergency button turn it
clockwise
13
Emergency stop (panic button) extended cable
receptacle
Enables the test subject to immediately cut off
the stimuli, in the event of an emergency
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#
Description
Mate with
1
Electrical box power switch
Not applicable
2
Electrical box fuse house
Not applicable
3
Electrical box power inlet
Internal power cord
4
PATHWAY label and serial number
Not applicable
5
JTAG receptacle
Use for technical maintenance (PATHWAY
technician only)
USB cable
6
Communication port
Use for communication with PC
USB cable
7
Service receptacle
Use for 4-bit TTL and analog output
Analog out and I/O flat cable
8
ECU control cable receptacle
Internal communication cable to
cooling unit
9
Electrical box coolant inlet receptacles
Internal coolant hose
Do not connect any equipment to the service receptacle during test subject
examination.
2 1 6 5 8
7
9 3 4
3.4 PATHWAY Electrical Box Back Panel (Internal)
Figure 12: Electrical Box Back Panel
The Electronic Box back panel is accessible from the maintenance door in the back of the
PATHWAY trolley. It contains the following receptacles and controls:
Table 7: PATHWAY Electrical Box Back Panel receptacles
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Before connecting the PATHWAY system to a power outlet, make
sure it has been in an upright position for a minimum of 3 hours!
Disregarding the above instruction will cause damage to the
PATHWAY system and Cooling Unit!
Complete and verify the entire PATHWAY setup and installation process
before using the system
For fMRI mode system installation see section 1415, page 149...
Safety
Computer must comply with IEC 950 – EN 60950 – UL 60950
Processor
Intel Core i3 4xxx or better
(avoid low power processors such as Atom, Pentium or Celeron)
Memory
4 GB RAM
Storage
128 GB
USB slots
2 free USB slots (3 for AlgoMed and Q-Sense CPM)
Monitor/Display
13’’ (15’’ recommended)
Screen
Resolution
1366 x 768 pixels, 96 DPI (max. 1920x1080)
Operating
System
Windows 7, 8, 10 32/64 bit
Other
Microsoft Office 2007 or above (required for viewing results in excel)
The computer used for Medoc Main Station software should be dedicated
for this purpose only. Medoc takes no responsibility for any conflicts which
may occur with other programs
For optimal performance disable any other resource heavy programs
running on the same computer such as Anti-Virus, Screen Saver, Hibernate
Mode, and Network connections.
4. Setup and Installation
The PATHWAY system installation is designed to be simple and fast. Follow the instructions
given below for selecting a location, installing and initial setup of the PATHWAY system.
Proper installation and operation of the equipment is important for ensuring the safety of the
tested subjects.
4.1 Computer Requirements
The requirements below are minimum requirements intended to be used as a guideline for
selecting a computer to use with Medoc Main Station software.
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The installation USB contains all of the unique system files. Keep it in a safe
place. It may be required for restoring the system configuration in case of
malfunction and/or service during remote control session by Medoc.
See TSA-II Technical Reference Service Manual for further details on the
system components.
4.2 Installation USB Content
The installation USB contains the MEDOC Main Station setup program and additional features
that are required for system normal operation, as detailed below:
1. MEDOC Main Station setup program.
2. Software license files.
3. Firmware
4. Technical Reference Manual.
5. Technical Reference Service Manual.
6. Remote assistance tools.
4.3 Setup and Installation Main Steps
PATHWAY System installation consists of the following steps:
1. Selecting an appropriate location for the system. See section 4.4, page 44.
2. Filling the cooling unit with the supplied coolant. See section 4.5, page 44.
3. Connecting the Thermodes and additional accessories to the system. See section 4.6, page
44.
4. Connecting the laptop and installing Medoc Main Station software. See 4.7, page 46.
5. Configuring the system.
4.4 Selecting a Location
An appropriate location for the PATHWAY system should meet the following criteria:
1. The room temperature should be kept between 18°C and 24°C.
2. The PATHWAY system should not be placed in a location, which is exposed to direct
sunlight, constant vibrations, or close to heaters or air conditioners.
3. The room in which the system will be located should be quiet, allowing the subject to
concentrate on the examination with minimum distractions.
4. The space allocated for the system should allow enough room to perform regular system
maintenance procedures.
4.5 Filling the System Coolant Reservoir
Fill up coolant in the coolant reservoir of the Cooling Unit (ECU). Make sure you add the
appropriate amount of coolant according to the instructions. Please refer to section 19, page
161.
4.6 Device Connections
1. Ensure that the laptop meets the minimum computer requirements.
2. Make sure that the laptop and PATHWAY unit are turned OFF.
3. Connect Thermodes and accessories according to your application, see Figure 13Error!
Reference source not found.
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Make sure the all Thermode connectors are properly connected and
secure in place. Make sure that there is no coolant leakage from the
water connectors
Laptop and printer are not supplied by Medoc.
The computer used should be dedicated only to PATHWAY system.
Medoc takes no responsibility for any conflicts which may occur with other
programs installed on the same computer.
The total power consumption of the laptop and printer connected to the
power inlet of the trolley must not exceed 330 W.
Note that the power supply is sufficient of laptop and printer only (1.5A)
The external laptop and printer must be connected to the trolley power
outlet or through a Medical Grade Isolation Transformer only.
The USB cable connecting between the PATHWAY and the laptop should
only be connected after installation of Medoc Main Station software. See
section 4.9.
4. Connect the laptop (and printer if using) to the voltage output connector at the back of the
PATWAY trolley. See Figure 14
Figure 13: Pathway Connection Diagram
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The SIP/SOPs (signal input and outputs) must be connected to medical
grade safety approved equipment for Canada and the United States by a
recognized certification agency, which is connected to the common
protective earth of the system.
Do not connect any equipment to a PATHWAY system that has not been
specifically authorized and approved by Medoc.
Depending on the current configuration of the computer, the MEDOC Main
Station installer may require the installation of additional components. The
installation procedure may take several minutes.
Disable any antivirus that runs on the PC before installing Medoc Main
Station.
Software installation can be performed only by Windows System
Administrators only
Users with Administrative privileges may not be enough.
Figure 14: Trolley Electrical Connectors
5. Connect the PATHWAY power cord to an AC grounded outlet.
4.7 Software Installation
The installation procedure of MEDOC Main Station software can only be performed by a user
with windows system administrator rights. Without appropriate access rights, the
installation procedure may fail.
Users with previously installed versions of Medoc Main Station should review the upgrade
instructions before proceeding.
The following instructions will guide you through the installation procedure:
1. Insert the USB drive into an available USB port on the computer
2. Open the folder to view files.
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Keep all liquids away from the PATHWAY system.
Unplug the power supply of the PATHWAY system from electricity if it is
not to be used for a long period of time.
Do not block airflow anywhere around the PATHWAY system and
Thermode.
When all setup and installation procedures have been completed you can
start using the system in accordance with the operation instructions in
section 5.
3. Double-click Setup.exe to start software installation
4. Click Next to continue the installation.
5. Select the file location where Medoc Main Station should be installed. You can use the
location recommended by the installation. Click Next to continue.
6. Select the location of the Medoc Main Station shortcuts in the start menu. You can use the
location recommended by the installation. Click Next to continue.
7. Installing normative data – please read the agreement carefully. If you agree to the term
please choose to install normative data. Click Next to continue.
8. Privacy – please read the terms carefully. If you agree please choose to allow data
collection. You may cancel this option any time later if you choose to.
9. The installation is now in progress. Depending on your computer configuration it may take
up to several minutes.
10. After installation has completed, click Finish to close the wizard.
11. Restart your Computer.
12. Medoc Main Station software is now ready to be used.
4.8 Unit Protection
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Prior to powering up the system, pay extra attention to ensuring that the
Thermode coolant connectors are properly connected.
Make sure that all communication and power cables, accessories and
Thermodes are properly connected to the system!
Figure 15: PATHWAY cart – back doors
Figure 16: Communication port - COM
Continue to section 4.10, page 49, for detailed instructions on how to
activate your product
Continue to section 5, page 50 for detailed operating instructions
Make sure to enable the connected Thermodes and set them as current
according to Thermode management instructions in the PATHWAY Service
Manual under Thermode Management section.
Communication
port
4.9 Powering up the PATHWAY System
1. Connect the computer to PATHWAY using the USB cable. Connect the USB cable to the
COM connection port locate at the back of the PATHWAY cart inside the right door, see
Figure 15, and Figure 16 below
1. Power up the PATHWAY system by using the main switch on the front of the PATHWAY
trolley. See Figure 9, page 38.
2. Let the system run for about 10 minutes, before starting Medoc Main Station software.
3. Start Medoc Main Station software by double-clicking the icon
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4.10 Product Activation
When starting Medoc Main Station software for the first time, you will be asked to register your
new system and activate the software. Product registration and software activation is simple
and fast and it will enable you to maintain full use of Medoc Main Station software as well as:
Warranty on your newly purchased Medoc systems
Access to Technical Support and Customer Service assistance
Software updates and new product notifications
Product support alerts
Please note that if you don’t activate the software within the designated time, the software will
work in demo mode only.
To complete the activation process, simply start Medoc Main Station software and follow the
instructions given in the activation wizard. If the activation wizard is not displayed when you
start Medoc Main station Software, go to the Home screen, select Options and then select
Product Registration. See Figure 17.
If at any point during the product activation process you encounter any difficulties please
contact Medoc support at [email protected] for assistance.
Figure 17: Home screen product registration link
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Make sure that Thermodes are not attached to a human subject before selftest is complete.
Before turning on the PATHWAY system, make sure that the Thermode main
plugs and water connecters are securely connected to the PATHWAY
system.
The Thermode should be attached to the subject’s skin only when
performing a test. Do not attach the Thermode to the subject during system
Self-Test, while programming the system or performing maintenance.
Do NOT Connect the PATHWAY computer to a network while performing
tests with the system!
It is not allowed to connect the PATHWAY computer to a network while
running tests with the system!
Make sure that all the Thermodes licensed for your PATHWAY system are
connected and the Electronic Box power switch is turned ON, before you
power up the system Main Switch.
Failure to follow this instruction will result in damage to the External
Cooling Unit.
5. Operation
The purpose of the following chapters is to specify the PATHWAY applications and to bring indetail step-by-step instructions for using the system.
This chapter specifies PATHWAY behavior at start up, and MEDOC Main Station basic
components.
5.1 Safety Procedures and System Self-Test
Upon start-up the system performs a self-test in which system sensors are being tested. If a
malfunction is detected, an appropriate message is displayed and the system cannot operate
until that malfunction is resolved.
5.2 Starting PATHWAY
1. Turn ON the PATHWAY unit, by using the main power switch located in the trolley front
panel. See Figure 9, page 38.
2. Turn ON the computer
3. Start Medoc Main Station software by double-clicking the icon
4. The Home screen is displayed showing the available devices (license dependent).
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Initial login Username and Password are both admin.
For more information on user management please refer to section 10.1.6
Figure 18: Home Screen
5. To select PATHWAY, click on the PATHWAY image.
6. When the login screen is displayed, enter your user name and password and select
"PATHWAY" in the "connect to" field.
Figure 19: Login Screen
7. While the software is establishing communication with the device the following screen may
be displayed:
Figure 20: PATHWAY Splash Screen
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8. When communication is established, the system will enter SAFE MODE and remain in this
state until completing the system Self-Test, see section 5.1 above. Make sure the
Thermode is not attached to the Subject and click on OK on the following message:
Figure 21: Self-Test Prompt
9. The system will perform a complete Self-Test of all enabled Thermodes according to your
system settings.
10. After the system Self-Test has completed successfully, the system state will change to
REST MODE.
Figure 22: PATHWAY in Rest Mode
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Note that the status line also indicates the type and model of the Thermode
currently active (circled in red, above).
Menu Bar
Toolbar
Data Display Area
Status Line
Search Row
Current
Information
Enabled
Information
5.3 Basic Operation
As soon as the self-test is successfully completed the TEST screen is displayed:
Selection
Thermode
Figure 23: Test Navigator – Main Menu
The Test screen enables you to select a patient, program and body site before starting the test
procedure.
The TEST screen menu consists of the following components:
Menu Bar – Perform general and software related operations
Toolbar – Quick access to patient and program editors and saved test results
Search Row – Filter the data for quick access to patients and programs
Current Selection Information – Display of current selections made by user
Current Thermode Information – Display of enabled Thermodes
Data Display Area – View list of patients, programs or body sites
Status Line – Continues real-time display of PATHWAY status and Thermode
temperature.
The components are detailed in the following sections.
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Menu
Option
Description
File
Export
Export selected Patient data, Program parameters or
Test Results to *.ats file format.
The *.ats file format is encoded and can be read only by
MEDOC software, enabling simple backup, export and
import options while maintaining patient confidentiality.
For detailed export and import instructions see relevant
sections in Patient, Program, and Results Management
chapters.
Import
Import Patients, programs and test results saved in *.ats
file format. See above description on Export.
Export to Excel
Export Test Results to MS Excel format, for data analysis.
Print
Print Test Results as a Report (enabled in the Results
screen). Refer to section9.3 for further information.
Logoff
Log off and switch users without exiting the software or
shutting down PATHWAY.
Switch Device
Return to Home Screen and select another device or
change preferences.
Exit
Exit MEDOC Main Station.
View
Test
Switch to Test Editor screen to perform and manage tests
from the available patient and program library.
Patients
Switch to Patient Editor screen for managing Patient lists.
Programs
Switch to Program Editor screen for managing programs
and protocols.
Results
Switch to Results screen to view and manage saved test
results.
Settings
Software
settings
MEDOC software related configuration and preferences.
Hardware
settings
PATHWAY system and Thermode hardware configuration
and management.
Test settings
Test configuration and display preferences
Status
Switch from On-Line to Demo Mode
Utilities
Department
Manage Department list
ICD 9
Manage list of ICD 9 codes
Probe Files
import or export ATS or CHEPS Thermode calibration
details
Normative
Data
Normative Data database and Editor.
Black box
System logs (populated only in case of suspected error)
5.3.1 Menu Bar
The Menu bar consists of the following options:
Table 8: Menu Bar options
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Menu
Option
Description
Device
Recovery
Manually initiate PATHWAY system self-test in case safety
was triggered.
Log Files
Software log files
Help
Operating
Manual
Link to the PATHWAY Operating Manual
Service Manual
Link to the PATHWAY Service Manual
Service Call
Submit a Service Call via Medoc web site*.
FAQ
FAQ on Medoc web site*.
About …
System and software information including license details
*internet connection required
5.3.2 Toolbar
The Toolbar consists of shortcuts to the different views:
Test Navigator – Select test parameters
Patients – Manage patient database
Programs – Manage program list
Results – View, export or print test results
5.3.3 Search Row
The Search Row allows you to filter the displayed data, in order to find the required data
quickly. To use the filter, place the cursor in the in search row, in the column you want to filter
by and start typing the beginning of the word.
5.3.4 Current Selection Information
Current selection panel displays the currently selected items. The data may vary depending on
the current view. While in test navigator for example, the current selection will show the
currently selected patient, program, body site and enabled Thermodes.
5.3.5 Data Display Area
Displays list of data which is relevant to the current screen.
5.3.6 Status Line
The Status bar displays important information about the status of the connected device. If the
status line is empty, MEDOC Main Station is not connected to any device. When connected to
the PATHWAY system, the status line displays the following information as described in Table
9.
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Information
Description
Device
The device currently in use and connected to Medoc Main Station
Status
The current status of the system, either Demo or On-Line.
Com
Communication status between the system and the laptop. A green
indicator is displayed for ON and a red indicator for OFF.
State
The state of the Temperature Control Unit. The following modes are
available: Rest, Engineering, Safe and Test run.
Thermode
Indicates the type and model of the Thermode currently active: CHEPS
or ATS; 30x30mm; 16x16mm; 5x5mm; Intra oral; GSA; fMRI or
standard.
Heater
Temperature of the heater (CHEPS only).
TEC
Temperature of the Thermode (ATS only)
Water
Temperature of the coolant.
Safety
Safety status. A green indicator is displayed for OK and a red indicator
for Safe Mode activation– in Safe Mode Thermode power is disconnected
system remains non-functional, until the malfunction is resolved.
Table 9: Status line parameters
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Make sure you are familiar with the stimulation method before you start the
test procedure
Inform the subjects how to operate the applicable controls, and request
them to concentrate on the perceived sensations throughout the full
duration of the test.
Inform the subjects that they should use the Panic Button in case they are
feeling anxious, scared, or simply “had enough”.
Test tab
highlighted
Test
Navigator
6. Test Procedure and Management
Starting a test procedure is only possible from the Test Navigator screen
Figure 24: Test Management Main Screen
The stimulation procedure (test) consists of the following main steps:
Select Patient– Select the test subject’s file from the database.
Select Program–Select the relevant program to be used for the test.
Select Body Site– Select the body site and its details for the current test. This step
is optional.
Apply Stimuli –Perform the test
Save/Print Test Results –Print test report and/or save test data for future
reference (This step is optional).
The stimulation procedure steps are described in detail in the following sections.
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The Patient List can be sorted according to any of the displayed fields. Click
the relevant column header to sort the list.
Patient details can only be viewed from the Test screen. For editing, refer
to Patient Management section (section 8, page 91).
It is not possible to run a test before you select the tested subject and
program. The “Go to Test” button will remain disabled as long as test
details are not complete.
Search
Row
Show/Hide
Details
6.1 Selecting a Patient
1. Click the Select Patient button on the Test Navigator
2. Use the Search Row (see section 5.3.3 above) to filter and sort list in order to find the
relevant patient entry.
Figure 25: Patient Selection Menu
3. Click the patient entry to select (or double-click to select and move on to the next step).
The selected entry will be displayed in the current selection details in the left panel.
4. In order to view patient details, click on the Show Details button.
5. To hide the details click on the Hide Details button to view the patients list only.
6. Click on the Clear button to clear Current Test information if required.
7. Proceed to the Selecting a Program section.
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The Program List can be sorted according to any of the displayed fields.
Click the relevant column header to sort the list.
Program details can only be viewed from the Test screen. For editing, refer
to Program Management section (section 7, page 66).
Display program details.
Display program graph preview (selected
methods only)
View test instructions.
View recent program modification dates.
Search
Row
Show/Hide
Details
6.2 Selecting a Program
1. Click on the Select Program button from the Test Navigator
2. Use the Search Row (see section 5.3.3 above) to filter and sort list in order to find the
relevant program entry.
Figure 26: Program Selection Menu
3. Click the program entry to select (or double-click to select and move on to the next step).
The selected entry will be displayed in the current selection details in the left panel.
4. In order to view program details, click on the Show Details button.
5. The following options are available in the Program Details view:
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It is not possible to run a test before you select the tested subject and
program. The “Go to Test” button will remain disabled as long as test
details are not complete.
6. To hide the details, click on the Hide Details button to view the program list only.
7. Click on the Clear button to clear current selection if required.
8. Proceed to the Selecting Body Site section if you want to select a site for the specific
test, or click on the Go to Test button in order to run the test without a specific body site
selection.
6.3 Selecting a Body Site
Selecting a body site for the test is optional. A test can be initiated without selecting a body
site.
1. Click on the Select Body Site button in the Test Navigator.
Figure 27: Body Site Selection Menu
2. Click on the Dermatome (Dermatomic area) you wish to use in the current test.
An enlarged view of the selected dermatome and a list of specific sites will be displayed on
the right.
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Make sure you have selected both a Patient and a Program before you try
to proceed with an actual test.
Figure 28: Select Body Site – Specific site selection
3. Use the Zoom In/Out controls for a more precise selection
4. Use the Flip Image control to switch between Anterior / Posterior view
5. Complete the site selection by selecting one of the Specific Sites. The selected site will be
displayed in the current test details in the left side bar.
6. Click the "Go to Test" button to proceed to the test.
6.4 Running the Test
1. Click on the Go to Test button
The following screen is displayed:
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At this point attach the Thermode to the subject.
Caution! DO NOT use any electrode paste, jelly or other material on the
contact point between the Thermode and the test subject's skin.
1. Make sure the subject holds the panic button, and knows how to use it in
case of an emergency.
2. Place the Thermode on the intended stimulation site so that the contact
plate makes the best possible contact with the skin, fastening it lightly
with the attached strap.
3. It is recommended to first fasten the strap around the area to be
stimulated and then tighten the strap by pulling it an additional 2 cm
before fastening the two ends.
Subject must hold the Panic Button during the entire duration of the test!
Figure 29: Pre-Test Screen
2. Click on the Start Pre-test button
The system performs a short pre-test, and stabilizes on the Baseline Temperature.
3. When the pre-test is complete, a message will be displayed on the screen.
4. Click on the Start button
5. To pause the stimulation, click on the Pause button
6. To stop the stimulation, click on the Stop test button
The first click stops the test, and initiates the Finalizing test procedure (accompanied by a
message) which saves relevant information in the Black Box in case of an error.
A second click aborts the test immediately.
7. Once a test has finished, it is possible to use the mouse curser to display the exact time,
temperature and other available information at any given point.
8. Click the Save button to save test results and stimulation data.
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Automatic zoom along the temperature axis. The temperature axis
scale expands according to maximum temperature currently displayed
on the screen. To reset the automatic zoom click the button again.
Alternatively, change zoom manually by using the +/- buttons.
Reset the zoom to the original (default) scale.
Change the zoom along the time/trial axis, by changing the value in the
spin box at the bottom right of the graph. Use the ↑/↓ arrow keys or
type the desired value in the box.
Print test results as a report. Refer to section 9.3 for details.
Save the stimulation data.
Display test instructions for the subject. To create or edit the default
instructions, refer to section 10.3.6.1 page 121.
Play audio test instructions for the subject. To assign an audio file with
default instructions, refer to section10.3.6.2, page 129.
Return back to the Test Navigator to start a new test.
Test results are not saved automatically. Remember to save the test
results if needed, before leaving the Test Screen.
Indicates positive subject response in Limits, Levels, TSL and Search
protocols.
Indicates negative subject response in Limits, Levels, TSL and Search
protocols.
Trigger the next stimulus. Available only when the manual trigger
option is selected. The button is enabled only when the system expects
a trigger.
Edit the program locally. The edited parameters are effective only in
the specific test and the program parameters are not changed in the
data base.
The system will prompt you to save the stimulation data before starting a
new test or exiting the current session.
After concluding a stimulation session, always clean the Thermode contact
plate. For further details, refer to section 23, page 175.
6.4.1 Test and Post-Test Options
Table 10: Test Run options
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Do NOT immerse the Thermode in any kind of liquid.
Legend
Sequence and
Trial Data
Stimuli Display
Statistics
Temperature
6.4.2 Temperature Graph Display
During the test, the test graph is generated and displayed on the screen. Following is an
example:
Figure 30: Real-Time Test
The following information is displayed:
Stimuli display (including CoVAS and events where applicable)
Current probe and program details.
Current sequence and trial data
Legend
Axes labels: Temperature axis on the left and CoVAS on the right (where applicable)
Statistics Panel: hidden by default. To view in full click on it. To keep the display
permanently open, use the pin icon ( ) on the top right corner. Click again to hide.
Test and Patient Details Panel: hidden by default. To view in full click on it. To keep
the display permanently open, use the pin icon ( ) on the top right corner. Click
again to hide.
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Button
Key
Action
S
Can be used instead of the Stop button to finalize;
then stop the test.
/
/ /
Spacebar
Can be used instead of the following buttons in
sequence: pre-test / run test / pause / resume
test.
Y
Can be used instead of the YES button.
Not available in Search method.
N
Can be used instead of the NO button.
Not available in Search method.
T
Can be use instead of the Trigger button.
Tab
Wrong Sensation option.
Available in Levels and TSL only.
A
Accept test subject response.
Available only in Levels method while using Manually
Select option for No Response On Destination.
I
Ignore test subject response.
Available only in Levels method while using Manually
Select option for No Response On Destination.
Delete
To Delete / Undelete a trail from statistics of a
Limits test.
Available only after test is complete and before it is
saved.
Delete trail is colored in Yellow.
Left and
Right Arrow
Allow to select a trail to repeat when test is paused.
Available in Levels and Limits only.
6.4.3 Test Run Keyboard Shortcuts (Hot Keys)
Keyboard shortcuts (hot keys) are available for several test functions enabling control of the
test from the keyboard. Table 11 below describes the available options.
Table 11: Hot Keys
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Create a new program
Duplicate selected program
Delete selected program
Edit selected program
Search Row
Current
Selection
Create / Edit /
Delete Buttons
Show / Hide
Details
7. Program Management
This chapter explains how to create and edit stimulation programs. The specific program
parameters for each method will be described in the sections below.
7.1 Program List
The Program screen displays the list of available programs.
1. To access the program database, click the Programs button in the toolbar. The following
screen is displayed:
Figure 31: Program Management screen
2. Use the search row to filter the program list
3. The current selection pane shows the details of the currently selected program.
4. The following editing options are available from the Program Management screen:
5. To view program parameters in more detail (without editing) use the Show Details
button. To return to program list, click on the Hide Details button.
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Display program details.
Display program graph preview.
Available on selected methods.
View instructions for the selected test.
View recent program modification dates.
Program details cannot be edited from the Program Details view.
Figure 32: Program Management – Program Preview
6. The following viewing options are available from Program Details view:
7.2 Creating a New Program
To create a new program, perform the following procedure:
1. From the Programs screen, click on the Create New Program button
The following dialog is displayed:
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Parameter
Description
CHEPS
Can operate with one of the following methods: Ramp & Hold, Pulses,
Search, and Limits.
ATS
Can operate with one of the following methods: Ramp & Hold, Pulses,
Search, and Limits.
Mixed (Chain)
For a chain program composed of one or more PATHWAY programs
Figure 33: New Program Screen
2. From the Probe Type drop-down list, select the required probe. The following options are
available (in accordance with your licensing agreement):
Table 12: Probe Type options
3. From the Method drop-down list, select the required stimulation method (Ramp & Hold,
Pulses, Search, Limits, Levels or TSL).
4. Type the program name.
For faster identification, it is advisable to type a meaningful name.
5. Click OK.
The Program Editor screen is displayed. For detailed instructions about the Program
Editor see section 7.6, page 69.
7.3 Remove a Program
To remove a program from the program list:
From the Programs screen, select the program to delete and click on the remove program
button
7.4 Duplicate a Program
To duplicate a program from the program list:
From the Programs screen, select the program to copy and click on the copy program button
A copy of the selected program will be added to the program list with the suffix “(1)” in the
program name.
7.5 Edit a Program
To edit a program from the program list:
From the Programs screen, select and double click the program to edit or click on the edit
program button
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Parameter
Description
Program name
The program name (editable).
Probe
The probe type to be used with this program (ATS or CHEPS)
Description
Program description. To edit, click the arrow and type free
text to describe the program. The description will become active
when text is entered.
Updated on
The date program was last edited on (automatic)
Start test/End test
Start / End test events: can be indicated by TTL, sound, or both.
Time between
trials
(Relevant only to
specific Methods)
Definition of how to calculate time between trials:
Onset to Onset: From the onset of the previous to the
onset of the next
End to Onset: From the end of the previous to the onset
of the next (default)
7.6 Program Editor
When creating or editing a program, the Program Editor screen opens and
enables you to modify program parameters
Figure 34: Program Editor Screen
The top part of the program editor displays global details which are available for all methods.
The lower part of the program editor displays the specific program parameters according to the
selected method. For detailed information about the program parameters, continue to
section 7.7, page 71
The following program details are available:
Table 13: Program Details
The following options are available from the Program Editor screen:
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View program revision history by version date and username.
Edit text and audio instructions. Refer to section 7.10, page 88
Exit Program Editor screen
Copy the selected sequence
Paste the copied sequence
Insert a new sequence at the end of the test
Insert a new sequence after the selected sequence
Delete the selected sequence
Preview the temperature graph
Check that all program parameters are valid
When adding or editing programs, follow these rules:
1. Enter meaningful information in the Program Description section of the
screen.
2. Define all the parameters of a sequence for that sequence to be valid.
3. If not all the sequences are displayed, use the horizontal scroll bar to
display the ones that are out of sight.
Missing or incorrect parameters are highlighted by an icon next to the
relevant field. A short description of the problem is displayed when holding
the cursor over the relevant icon.
7.6.1 Next Sequence Definition
In Limits, TSL, Ramp & Hold, Pulses and Search protocols additional settings are available in
the top part of program editor, allowing different options for next sequence definition during
the program run:
Figure 35: Program Editor Next Sequence Definition
Two checkboxes are available and unchecked by default:
- Randomize Sequences: If this checkbox is checked the sequences order during
program run will be randomized
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- Manually define the next sequence: If this option is selected, the operator will
receive the following dialog window at the end of the sequence, allowing him to specify
the next sequence he would like to perform:
Figure 36: Manual Next Sequence Definition
Note: this option is available if the program contains more than 2 sequences;
otherwise this option will be dimmed.
- If both checkboxes are unchecked the sequences order will be according to their
order in program editor (sequence number)
7.7 Program Details
The following sections described the program details for each of the applicable methods.
7.7.1 Ramp and Hold
In this method, the temperature rises (or falls) to a predetermined destination, at a
predetermined rate, remains there for a predetermined duration, and proceeds to the next
destination. For an example graph and an explanation of the method, refer to section 2.8.1,
page 32.
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Parameter
Description
Baseline (°C)
Temperature from which each new stimulation sequence begins.
ATS: 10°C – 45°C
CHEPS: 30°C – 45°C
Time before
sequence (sec)
The time interval before the first trial. Valid range: 0 to 600 (sec).
Trigger
Trigger mode:
Automatic – the stimulus will start automatically after the
defined Inter Stimulus Interval (ISI).
Manual – The operator must initiate the onset of the
stimulus after the defined ISI (using the manual trigger,
keyboard shortcut or TTL-IN)
Destination
temperature (°C)
Defines the destination temperature for all trials in the current
sequence. Valid range is limited by safety limitations and depends on
the duration time.
Destination rate
(°C/Sec)
Defines the temperature change rate from the baseline to
destination temperature.
CHEPS: 0.1 to 70°C/Sec
ATS: 0.1 to 8°C/Sec
Destination criterion
Temperature: The system recognizes that it has reached the target
temperature, by monitoring the temperature.
Time: The system recognizes that it has reached the target
temperature, by referring to the theoretical time that is required to
reach the destination temperature according to the selected rate.
Figure 37: Program Menu – Ramp and Hold
The table below describes the program parameters available for Ramp and Hold method:
Table 14: Program Parameters
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Parameter
Description
Duration time (sec)
Defines the duration for Thermode temperature to remain at
destination temperature before returning to baseline. Valid range: 0
to 600 (sec)
Return option
Defines whether the temperature returns to the baseline or proceeds
to the destination temperature of the next sequence. Select the
relevant option from the drop-down menu.
Note that when the “next destination” option is selected certain fields
become inactive, because they are no longer relevant (for example,
the Number of Trials turns to ‘1’).
Return Rate
(°C/Sec)
Defines the temperature change rate from the destination
temperature back to baseline.
CHEPS: 0.1 to 40°C/Sec
ATS: 0.1 to 8°C/Sec
Number of Trials
The number of trials per sequence. Valid range: 1 to 100
Enable Pain Rating
Enable or disable the option to add numerical pain ratings during the
test. If enabled, the operator will be prompted to enter a number
between 0 and 100 at the end of every trial in the sequence.
The pain rating option can be further customized with the pain rating
add-on license. Available configurations include multiple ratings per
trial, customized input range, limited input duration and etc. For
more information see section 17.
Randomize with next
Randomize trials with next sequence
ISI Min (sec)
Minimum Inter-Stimulus-Interval (ISI). Valid range: 0 to 600 (sec)
ISI Max (sec)
Maximum Inter-Stimulus-Interval (ISI). Valid range: 0 to 600 (sec).
Actual ISI will be randomized between min and max values.
Standard events
Different events which can be indicated during the test via TTL or
Sound. See section 7.8
Temperature events
Indicate different temperature points via TTL or Sound. See
section 7.9.
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Parameter
Description
Baseline (°C)
Temperature from which each new stimulation sequence begins.
ATS: 10°C – 45°C
CHEPS: 30°C – 45°C
Time before
sequence (sec)
The time interval before the first trial. Valid range: 0 to 600 (sec).
Trigger
Trigger mode:
Automatic – the stimulus will start automatically after the
defined Inter Stimulus Interval (ISI).
Manual – The operator must initiate the onset of the
stimulus after the defined ISI (using the manual trigger,
keyboard shortcuts or TTL-IN)
High destination
temp (°C)
Defines the high destination temperature for all trials in the current
sequence. Valid range is limited by safety limitations and depends on
the duration time.
Low destination
temp (°C)
Defines the low destination temperature. Relevant if there is more
than one pulse per trial.
7.7.2 Pulses
In this method, the temperature rises or falls at a very rapid rate, and then returns to a
predefined starting point of a new pulse. For an example graph and an explanation of the
method, refer to section 2.8.2, page 34.
Figure 38: Program Menu – Pulses
The table below describes the program parameters available for Pulses method:
Table 15: Program Parameters
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Parameter
Description
Offset (°C)
The Offset is used to control the overshoot of the Thermode
temperature when it reaches the destination temperature. To
determine the offset required, run the program with different values
until you are satisfied with the results.
Note that increasing the offset will reduce the overshoot and
decreasing the offset will increase the overshoot.
Valid Range: 0 – 10 (default is 2). The software will display a
warning if the offset parameter is set to be lower than then the
default. The default offset can be set in the Test Settings.
Destination criterion
Temperature: The system recognizes that it has reached the target
temperature, by monitoring the temperature.
Time: The system recognizes that it has reached the target
temperature, by referring to the theoretical time that is required to
reach the destination temperature according to the selected rate.
Number of pulses in
trial
Number of pulses, between high and low destinations, in a trial (until
temperature returns to baseline). Valid Range: 1 to 100
Number of Trials
The number of trials per sequence. Valid range: 1 to 999
Randomize with next
Randomize trials with next sequence
Use dynamic factor
Dynamic factor locally offsets the LUT, according to a predetermined
value (Hardware settings General). Refer to section 10.2.1 page
117XX
ISI Min (sec)
Minimum Inter-Stimulus-Interval (ISI). Valid range: 0 to 600 (sec)
ISI Max (sec)
Maximum Inter-Stimulus-Interval (ISI). Valid range: 0 to 600 (sec).
Actual ISI will be randomized between min and max values.
Standard events
Different evens which can be indicated during the test via TTL or
Sound See section 7.8
Temperature events
Indicate different temperature points via TTL or Sound. See
section 7.9.
The bottom of the screen displays the total records (sequences) in the
current program.
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Parameter
Description
Search device
Specify the device which will be used to control the temperature:
CoVAS or Response Unit
Time before
sequence (sec)
The time interval before the first trial. Valid range: 0 to 600 (sec).
Baseline (°C)
Temperature from which each new stimulation sequence begins.
ATS: 10°C – 45°C
CHEPS: 30°C – 45°C
Destination
temperature (°C)
Defines the destination temperature before the search starts. Valid
range is limited by safety limitations and depends on the duration
time.
Destination rate
(°C/sec)
Defines the temperature change rate from the baseline to destination
temperature.
CHEPS: 0.1 to 70°C/Sec
ATS: 0.1 to 8°C/Sec
7.7.3 Search
In this method, the intensity of the stimulus changes according to the patient's response.
Using the response unit or CoVAS the patient can control whether the temperature will
increase or decrease and to what extent. For an example graph and an explanation of the
method, refer to section 2.8.3, page 35.
Figure 39: Program Menu – Search
The table below describes the program parameters available for Search method:
Table 16: Program Parameters
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Parameter
Description
Search Rate
(°C/sec)
Defines the temperature change rate during the search period.
Duration time (sec)
Defines the duration of the search period. Valid range: 1 to 600
Number of Trials
The number of trials per sequence. Valid range: 1 to 100
ISI Min (sec)
Minimum Inter-Stimulus-Interval (ISI). Valid range: 0 to 600 (sec)
ISI Max (sec)
Maximum Inter-Stimulus-Interval (ISI). Valid range: 0 to 600 (sec).
Actual ISI will be randomized between min and max values.
Standard events
Different evens which can be indicated during the test via TTL or
Sound. See section7.8
Temperature events
Indicate different temperature points via TTL or Sound. See
section 7.9
Parameter
Description
Modality
Defines the direction of stimuli: temperature will decrease for Cold
Sensation (CS) and Cold Pain (CP), and increase for Warm Sensation
(WS) and Hot Pain (HP).
7.7.4 Limits
In this method, the system generates a number of stimuli of continuously changing intensity.
With each stimulus, when the subject perceives a predefined sensation, he/she manually stops
the stimulus. For an explanation of the method, refer to section 2.8.4, page 36.
Figure 40: Program Menu – Limits
The table below describes the program parameters available for Limits method:
Table 17: Program Parameters
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Parameter
Description
Baseline (°C)
Temperature from which each new stimulation sequence begins.
ATS: 10°C – 45°C
CHEPS: 30°C – 45°C
Trigger
Trigger mode:
Automatic – the stimulus will start automatically after the
defined Inter Stimulus Interval (ISI).
Manual – The operator must initiate the onset of the
stimulus after the defined ISI (using the manual trigger,
keyboard shortcut or TTL-IN)
Rate (°C/sec)
Defines the temperature change rate from the baseline temperature
until the subject responds. Valid range: 0.1 to 4°C/Sec.
Return Rate (°C/sec)
Defines the temperature change rate when stimulus returns to
baseline temperature after the subject has responded. Valid range:
0.1 to 8°C/Sec.
Number of Trials
The number of trials per sequence. Valid range: 1 to 100
Randomize with next
Randomize trials with next sequence
ISI Min (sec)
Minimum Inter-Stimulus-Interval (ISI). Valid range: 0 to 600 (sec)
ISI Max (sec)
Maximum Inter-Stimulus-Interval (ISI). Valid range: 0 to 600 (sec).
Actual ISI will be randomized between min and max values.
Standard events
Different evens which can be indicated during the test via TTL or
Sound See section 7.8
7.7.5 Levels
In this method, the system generates a number of stimuli of changing intensity according to
the subject response. With each stimulus, the subject receives a stimulation of varying
intensity which is determined according to his previous response. Test is terminated after
predefined temperature step size and number of alternations is achieved. For an explanation of
the method, refer to section 2.8.5, page.
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Parameter
Description
Modality
Defines the direction of stimuli: temperature will decrease for
Cold Sensation (CS), and increase for Warm Sensation (WS).
Baseline (°C)
Temperature from which each new stimulation sequence
begins.
ATS: 20°C – 45°C
CHEPS: 30°C – 45°C
Trigger
Trigger mode:
Automatic – the stimulus will start automatically after
the defined Inter Stimulus Interval (ISI).
Manual – The operator must initiate the onset of the
stimulus after the defined ISI (using the manual
trigger, keyboard shortcut or TTL-IN)
Time Before
Sequence (sec)
The time interval before the first trial. Valid range: 0 to 600
(sec).
Destination Rate
(°C/sec)
Defines the temperature change rate from the baseline to
destination temperature. Valid range: 0.1 to 5°C/Sec
Figure 41: Program Menu – Levels
The table below describes the program parameters available for Levels method:
Table 18: Program Parameters
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Parameter
Description
Return Rate
(°C/sec)
Defines the temperature change rate from destination back to
baseline temperature. Valid range: 0.1 to 5°C/Sec.
Max. Time at
Destination (sec)
Defines the maximum duration for Thermode temperature to
remain at destination temperature before returning to baseline.
If subject's response is 'YES' – the temperature will
immediately return to baseline.
If subject's response is 'NO' – the temperature will remain at
destination for the maximum duration as specified.
Valid range: 0 to 600 (sec). May be limited by safety
limitations.
Min. Interval (sec)
Minimum Inter-Stimulus-Interval (ISI). Valid range: 0 to 600
(sec)
Max. Interval (sec)
Maximum Inter-Stimulus-Interval (ISI). Valid range: 0 to 600
(sec). Actual ISI will be randomized between min and max
values.
First Choice Step
(°C)
The initial step size that is used until the first 'YES' response is
given. Valid range: 0.2 to 5 °C
Final Choice Step
(°C)
The smallest step size that is used in the final Turns Around
Threshold. Valid range: 0.1 to 2 °C
Turns Around
Threshold
The number of turns (alternating 'YES' and 'NO' responses) at
the Final Choice Step which is required to complete the test.
Valid range: 1 to 10.
Number of Tests
The number of repetitions for entire test. Valid range: 1 to 5.
Dummy Option
Randomized dummy trials where no actual stimulus is given to
increase test reliability. Frequency of dummy trials is
randomized with an average of 10% of all trials.
Randomize
Randomize between trials of several tests.
Display Message
Defines when message to respond is displayed:
Destination – Display message upon reaching
destination temperature
Return to Baseline – Display message after
temperature returns to baseline.
No Response on
Destination
Defines the behavior of the program if the subject responds
after the Maximum Time at Destination is over. Relevant
only if Maximum Time at Destination is larger than 0 and
Display Message is set to Destination.
Always Accept – Accept subject’s response and
continue the test
Always Repeat – Ignore subject’s response and
repeat the same trial again
Manually Select – Manually select whether the
response should be accepted (press ‘A’) or
ignored (press ‘I’).
Standard events
Different evens which can be indicated during the test via TTL
or Sound See section 7.8.
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Parameter
Description
Temperature points
Indicate different temperature points via TTL or Sound. See
section 7.9.
Parameter
Description
Baseline (°C)
Temperature from which each new stimulation sequence
begins.
ATS: 20°C – 45°C
CHEPS: 30°C – 45°C
Time Before
Sequence (sec)
The time interval before the first trial. Valid range: 0 to 600
(sec).
First stimulus
Define direction of first stimulus: warm or cold
Increase Rate
(°C/sec)
Defines the temperature change rate for increasing
temperature. Valid range: 0.1 to 8°C/sec.
Decrease Rate
(°C/sec)
Defines the temperature change rate for decreasing
temperature. Valid range: 0.1 to 8°C/sec.
Number of stimuli
Number of stimuli until the test ends (each subject response is
counted as one stimulus.
7.7.6 Thermal Sensory Limen (TSL)
In this method, the system generates warm sensation and cold sensation stimuli, alternating
according to the subject response. The stimuli direction changes after each subject response.
For an explanation of the method, refer to section 2.8.6, page 36.
Figure 42: Program Menu – TSL
The table below describes the program parameters available for the TSL method:
Table 19: Program Parameters
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Parameter
Description
Trigger
Trigger mode:
Automatic – the stimulus will start automatically after
the defined Inter Stimulus Interval (ISI).
Manual – The operator will initiate the onset of the
stimulus after the defined ISI (using the manual
trigger, keyboard shortcut or TTL-IN)
Standard events
Different evens which can be indicated during the test via TTL
or Sound See section7.8
Temperature events
Indicate different temperature points via TTL or Sound. See
section 7.9.
Parameter
Description
Baseline (°C)
Temperature from which each new stimulation sequence begins. Valid
range:
ATS: 10°C – 45°C
CHEPS: 30°C – 45°C
7.7.7 VAS Search
In this method, the temperature of the first stimulus rises (or falls) to a predetermined
destination, at a predetermined rate, remains there for a predetermined duration, and returns
to baseline. Patient estimation of perceived magnitude of sensation is recorded for the first
stimulus. The intensity of the next stimulus is determined by patient response being higher or
lower than the desired pain rating. For a method explanation, refer to section 2.8.7 page 36.
Figure 43: VAS Search Program Editor
The table below describes the program parameters available for the VAS Search method:
Table 20: Program Parameters
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Trigger
Trigger mode:
Automatic – the stimulus will start automatically after the
defined Inter Stimulus Interval (ISI).
Manual – The operator will initiate the onset of the
stimulus after the defined ISI.
First destination
temperature (°C)
Temperature of first stimulus. Valid range may be limited by safety
restrictions, rate and duration time. Valid range (under no
restrictions):
ATS: 0°C – 55°C (-10°C – 55°C under special license)
CHEPS: 30°C – 55°C (20°C – 55°C under special license)
Destination Rate
(°C/sec)
Temperature change rate from baseline to destination. Valid range:
ATS: 0°C/sec – 8°C/sec
CHESP: 0°C/sec – 40°C/sec (max 70°C for heating).
Duration Time (sec)
Duration time at destination temperature. Valid range may be limited
by safety restrictions.
Valid range (under no restrictions): 0 – 600 seconds.
Return Rate
Temperature change rate from destination to baseline. Valid range:
ATS: 0°C/sec – 8°C/sec
CHESP: 0°C/sec – 40°C/sec (max 70°C for heating).
Search Mode
Search mode:
Automatic – starting from the second trial, the stimulus
parameters will be defined automatically by the predetermined
target pain rating and step size.
Manual – At the end of each trial the user will define the
destination temperature of the next trial, until the desired pain
rating is reached. The user also decides when to finish the
program (i.e. when the desired pain rating is achieved). In
manual mode the 'Target Pain Rating' and 'Step size'
parameters become dimmed.
Target Pain Rating
Relevant for Automatic search mode only.
Defines the pain rating that needs to be reached. If the actual pain
rating of the current trial is lower than 'Target Pain Rating' value, the
temperature of the next trial will increase by the Step Size (see
below) and vice versa.
Valid range: 1 - 100
Step Size (°C)
Relevant for Automatic search mode only.
Determines the step size by which the temperature will increase/
decrease in every new trial. The direction of the temperature change
will depend on the difference between the target and the actual pain
ratings (see above in 'Target Pain Rating' description)
Valid range: 0.1 – 10 (°C)
ISI Min (sec)
Minimum Inter-Stimulus-Interval (ISI). Valid range: 0 to 600 (sec)
ISI Max (sec)
Maximum Inter-Stimulus-Interval (ISI). Valid range: 0 to 600 (sec).
Actual ISI will be randomized between min and max values.
Standard Events
Different events which can be indicated during the test via TTL or
Sound. See section 7.8
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Adds the program selected from the Program List to the chained list, below
the selected program in the chained program list.
Deletes the selected program from the chained program list.
Moves the selected program up the index (up the list).
Moves the selected program down the index (down the list).
Temperature Points
Indicate when Thermode temperature reaches specific temperature
points. See section 7.9.
7.7.8 Chain Program
The purpose of the Chain Method is to chain several programs one after the other. The result
is a master program which runs the selected programs continuously, each program repeated
by the number of cycles defined and in order according to the indexed list.
Figure 44: Chain Program Editor
Figure 44 shows the program editor for a Chain program. The left column displays all the
programs currently in the database. The right column displays the selected programs to chain
together.
To add a program from the database to the chain program, click on the program name from
the program list on the left. The program will be added to the list on the right. Adjust the
number of cycles (first column from the right) to repeat the program if needed.
The following options are available for chain program:
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For other event types see:
Temperature Events section 7.9
User Defined Events section 10.3.2
1-bit and 4-bit TTL are sent only if the standard event is configured in the
program
7.8 Standard Events
Standard Events are pre-defined events that occur during the test such as the onset of a
stimulus or reaching the destination temperature. Events can be marked by a TTL and/ or
sound:
1. TTL Trigger – Pathway can send a TTL signal which can be used for synchronization with
external systems.
2. Sound – a sound can be played from the computer (speakers are required) when a certain
event occurs. This can be used as a cue for the subject to perform a certain task.
3. Every event is also marked on the screen during the test by an asterisk (*).
7.8.1 TTL Setup
Pathway can send two types of TTL signals:
1. 1-bit TTL is sent from the front panel TTL Out BNC connector (see Pathway front panel
connection in section 3.3, page 40).
2. 4-bit TTL is sent from the back panel Analog I/O connector (see Pathway back panel
connectors in section 3.4, page 42). The pin-out of the Analog I/O connector is detailed in
the Technical Reference Service Manual. To configure the 4-bit TTL words see section 0,
page 127.
The polarity of the TTL can be configured in Pathway hardware settings. Refer to
section 10.2.1 page 117 for further details.
The technical specifications of the TTL output are detailed in section 1.8 page 25.
7.8.2 Standard Event Configuration
To configure standard events in the required program, follow the steps detailed below:
1. From the Programs screen, select the program you want to configure standard events for
and double click to open the program editor or click on the edit program button
2. From the list of parameters, select the Standard Events option
Figure 45: Standard Events in Program Editor
3. Click the arrow on the left to open the standard event editor.
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Program
Method
Standard Events
Description
Ramp and Hold
Onset
The start of each trial in the sequence
Destination
Thermode temperature reached target temperature
End of duration
End of duration at target temperature
AUX
Time based event timed from the onset
Limits
Onset
The start of each trial in the sequence
Figure 46: Standard Event Editor
For each event that you want to configure mark the TTL and/or the Sound column to
activate. Once the event is activated, you can use the drop down list to select a different
event type (relevant for 4-bit TTL).
Figure 47: Standard Event Configuration
4. To configure an auxiliary event (time based event) select the last row with event type
‘AUX’. In the time column enter the time when the event should be sent (counted in
seconds from the onset of each trial in the selected sequence)
5. Click anywhere on the screen to close the Standard Events dialog.
6. The available standard events vary according to the test method. For a list of the available
standard events according to the program type continue to the following section.
7.8.3 List of Standard Events according to Program Type
The available standard events according to program type are detailed in the table below:
Table 21: List of standard events according to program type
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Program
Method
Standard Events
Description
Levels
Onset
The start of each trial in the sequence
Destination
Thermode temperature reached target temperature
End of Duration
End of duration at target temperature
AUX
Time based event timed from the onset
TSL
Destination
Subject response was detected
Pulses
Onset
The start of each trial in the sequence
Peak
The highest temperature recorded in a pulse.
Peak detection is performed in real time, therefore
there is a 50 [msec] delay between the occurrence
of the peak and the display of the TTL on screen.
AUX
Time based event timed from the onset
For other event types see:
Standard Events section 7.9
User Defined Events section 10.3.2
7.9 Temperature Events
Temperature Events are events that occur when the Thermode temperature reaches a specific
temperature as defined during program setup. Up to 5 different temperature events can be
specified per sequence. The temperature events can be marked by a TTL and/or sound. Please
refer to the section 7.8, page 85 for a more detailed explanation on TTL setup. Temperature
events are also marked on the screen during the test by a dot (●).
7.9.1 Temperature Event Configuration
To configure temperature events in the required program, follow the steps detailed below:
1. From the Programs screen, select the program you want to configure standard events for
and double click to open the program editor or click on the edit program button
2. From the list of parameters, select the Temperature Event option
Figure 48: Temperature Events in Program Editor
3. Click the arrow on the left to open the temperature event editor.
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Figure 49: Temperature Event Editor
For each event that you want to configure mark the TTL and/or the Sound column to
activate. Once the event is activated, you can specify the temperature and direction
(temperature increase or decrease) in which the event should occur.
4. Click anywhere on the screen to close the Standard Events dialog.
7.10 Test Instructions
Test instructions can be assigned to any program as a text file (to be read out loud by the
operator) and/or as an audio file which can be played before starting the test. The test
instructions can be edited globally for all programs of the same method (see section 10.3.6),
or separately for each program.
This section describes how to edit the test instruction for a specific program:
1. From the Programs screen, select the program you want to configure standard events for
and double click to open the program editor or click on the edit program button
2. From program editing options on the left, click on the edit test instructions button
Figure 50: Test Instructions Editor
3. To edit the text instructions:
3.1. Unselect the relevant Use Default Instruction checkbox
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Importing and/or exporting program data from different software versions
may result in compatibility errors and loss of data. Check database
compatibility before proceeding.
Figure 51: Edit text instructions
3.2. Click on the Edit button to open a rich text editor. Edit the text instructions and save
them (see also section 10.3.6.1)
4. To replace the audio instructions:
4.1. Unselect the relevant Use default instruction checkbox.
Figure 52: Replace audio instructions
4.2. Click on the Browse button and select an audio file to use as the audio instructions
(see also section 10.3.6.2)X
7.11 Import / Export Programs
Programs from the program list can be exported and saved for backup or imported into
another Pathway system. The export format uses a secure and unique format that can be
accessed by Medoc Main Station software only.
7.11.1 Export Programs
In order to export programs follow the procedure below:
1. Open the program list in the Programs screen.
2. Select the programs to export. Multiple selection is possible by holding down the Shift or
Ctrl and Shift buttons on the keyboard
3. From the menu bar select File and then Export.
4. Enter a file name for the exported programs and select the save location.
5. Click the Save button.
The selected programs are saved to the selected location under the selected name.
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7.11.2 Import Programs
In order to import programs follow the procedure below:
1. From the menu bar select File and then Import
2. Browse to the location of the saved programs and select the file to import
3. Click on the Open button. The programs will be added to the program list.
7.11.3 Solving Conflicts When Importing Programs
Medoc Main Station identifies any possible conflicts between existing programs and imported
programs. In case of conflict (e.g. programs have the same name) it is possible to manually
select how to handle the import. The following options are available:
1. Use Local – keep the existing program and ignore the imported program
2. Use Import – overwrite the existing program with the imported program
3. Keep Both – import the program and save under a different name.
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Create a new patient
Delete selected patient details.
Edit selected patient details
Deleting Patient Records also removes all associated test results!
Search Row
Current
Selection
Create / Edit /
Delete Buttons
Show / Hide
Details
8. Patient Management
This chapter explains how to add and edit patient records.
8.1 Patients List
The Patients screen enables you to manage the patient list.
1. To access the patient database, click the Patients button in the toolbar. The following
screen is displayed:
Figure 53: Patients List
2. Use the search row to filter the patient list.
3. The current selection pane shows the details of the currently selected patient.
4. The following options are available in the Patient Management screen:
5. To view patient details in more detail (without editing) use the Show Details
button. To return to patient list, click on the Hide Details button.
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Patient details cannot be edited from the Patient Details view.
Figure 54: Patient Management – Patient details preview
8.2 Adding a New Patient
To add a patient to the patients list:
1. From the Patients screen, click on the Add New Patient button
The Patient Editor screen is displayed:
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Missing or incorrect parameters are highlighted by an icon next to the
relevant field. A short description of the problem is displayed when holding
the cursor over the relevant icon.
The available patient fields can be customized. For further information,
refer to section 10.1.4.
Figure 55: Patients Editor Screen
2. Insert all the relevant patient data.
3. To add or edit the available departments see section 8.3, page 93.
4. Click the Save button
5. To return to the patient list click on the return button
8.3 Remove a Patient
To remove a patient from the patient list:
From the Patient screen, select the patient to delete and click on the remove patient button
Note that deleting a patient from the list also removes all the corresponding test results!
8.4 Edit Patient Details
To edit a patient from the patient list:
From the Patient screen, select and double click the patient record to edit or click on the edit
patient button
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Department management is enabled according to the authorization level of
the current user. For further information, refer to section 10.1.6
Importing and / or exporting patient data between different software
versions may result in compatibility errors and loss of data. Check
database compatibility before proceeding.
8.5 Add \ Edit Departments
The department list can be managed from the utility menu. It is possible to add, edit or
remove departments as needed. It is not possible to remove a department if there are patients
associated with it.
1. From the menu bar select Utilities and then Department.
The Edit departments menu is displayed:
Figure 56: Edit Department Menu
2. To add a new department, click the New button; then, type the department name.
3. To rename a department, select the required department; then click the Rename button.
4. To remove a department, select the required department; then click the Remove button.
At the prompt click the OK button.
5. To close the dialog, click the Close button.
8.6 Import / Export Patient Records
Patient details can be exported and saved for backup or imported into another Pathway
system. The export format uses a secure and unique format that can be accessed by Medoc
Main Station software only.
8.6.1 Export Patient Records
In order to export programs follow the procedure below:
1. Open the patient list in the Patients screen.
2. Select the patient records to export. Multiple selection is possible by holding down the
Shift or Ctrl and Shift buttons on the keyboard
3. From the menu bar select File and then Export.
4. Enter a file name for the exported patient records and select the save location.
5. Click the Save button.
The selected patient records are saved to the selected location under the selected name.
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8.6.2 Import Patient Records
In order to import patient records follow the procedure below:
1. From the menu bar select File and then Import
2. Browse to the location of the saved patient records and select the file to import
3. Click on the Open button. The patient records will be added to the patient list.
8.6.3 Solving Conflicts When Importing Patient Records
Medoc Main Station identifies any possible conflicts between existing patient records and
imported patient records. In case of conflict (e.g. patients with same unique ID) it is possible
to manually select how to handle the import. The following options are available:
1. Use Local – keep the existing patient record and ignore the imported one
2. Use Import – overwrite the existing patient record with the imported one
3. Keep Both – edit the conflicting field in the imported patient record and keep both records.
The “keep both” option only becomes available if the conflict no longer exists.
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Print test results as a report
Delete selected test result
Search Row
Current
Selection
Print Report /
Delete Buttons
Show / Hide
Details
9. Results Management
This chapter explains how to view, export and print reports from saved test results.
9.1 Results List
The Results screen displays the list of saved test results.
1. To access the results database, click the Results button in the toolbar. The following
screen is displayed:
Figure 57: Results List
2. Use the search row to filter the list of results.
3. The current selection pane shows the details of the currently selected test result.
4. The following options are available in the results management screen:
5. To view a test results in more detail, select the relevant row in the list and click on the
Show Details button. To return to result list, click on the Hide Details
button.
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Display details of program used in selected test results
Display patient details
Display Body Site.
Delete selected test results
Print test results as a report
Display test results
Show / Hide Normative data display (if applicable)
Show / Hide CoVAS data (if applicable)
Importing and/or exporting test results between different software
versions may result in compatibility errors and loss of data. Check
database compatibility before proceeding.
Figure 58: Result preview display
The following options are available from the detailed test result view:
9.2 Import / Export Results
Test Results can be exported and saved for backup, further analysis or to import to another
Pathway system. Test results can be exported using the default export format which is secure
and can only be accessed by Medoc Main Station software. Alternatively, results can be
exported to an excel file for further analysis.
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Figure 59: Description sheet example
Figure 60: Data sheet example
9.2.1 Export Test Results
In order to export test results follow the procedure below:
1. Open the result list in the Results screen.
2. Select the test result to export. Multiple selection is possible by holding down the Shift or
Ctrl and Shift buttons on the keyboard
3. From the menu bar select File and then Export.
4. Enter a file name for the exported test results and select the save location.
5. Click the Save button.
The selected test results are saved to the selected location under the selected name.
9.2.2 Export Test Results to Excel
In order to export test Results to MS excel format follow the procedure below:
1. Open the results list in the Results screen.
2. Select the test result to export. Multiple selection is possible by holding down the Shift or
Ctrl and Shift buttons on the keyboard. Each test result will be exported as a separate file.
3. From the menu bar select File and then Export to Excel
4. Select the save location and click OK to save.
5. Click the Save button.
The selected results are saved to the selected location.
The name of each result file is automatically generated according to the patient name, date,
and time of test. Chain results are exported to a new folder containing a separate file for each
sub-program of the chain program.
The Excel File Structure:
The excel file includes the following sheets (content may change depending on test method):
1. Description – Patient and test information.
2. Data – All test data organized in a data table including Thermode temperature, events
(when response unit button is pressed, triggers, standard events and etc.), CoVAS and any
other data if available.
3. Results – Summary of results depending on test method.
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9.2.3 Import Test Results
In order to import test results, follow the procedure below:
1. From the menu bar select File and then Import
2. Browse to the location of the saved test results and select the file to import
3. Click on the Open button. The results will be added to the test results list.
9.2.4 Solving Conflicts When Importing Test Programs
Medoc Main Station identifies any possible conflicts between existing test results and imported
test results. In case of conflict (e.g. patient and/or program already exist in the database) it is
possible to manually select how to handle the import. The following options are available:
1. Use Local – keep the existing test results and ignore the imported test results
2. Use Import – overwrite the existing program with the imported test results
3. Keep Both – Edit the conflicting fields of the patient or program data and keep both test
results.
9.3 Generate Test Reports
MEDOC Main Station has a powerful Analysis and Report Generator that can be customized as
needed.
In order to print test results follow the next steps:
1. Open the result list in the Results screen
2. Select one or more test results to generate reports from.
3. Click on the Print button
Figure 61: Analysis Reports Dialog
4. Select the type of report to print. The available report types depend on the selected
results. See section 9.3.1 for details about report types.
5. Select print preview option:
5.1. Display preview (default) – opens report in viewer. The report can be exported in
various formats (.pdf, .jpg and etc.) or printed.
5.2. Print without preview – report will be sent directly to the default printer specified on
your computer.
6. Select whether or not to add comments to the report
7. Click on the Generate button to preview / print report.
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Parameter
Description
Number of Trials
Specify number of trials to display (relevant only for trial based
programs such as Limits or Levels)
Start Time
Specify start time of graph (relevant only for time based
programs such as Ramp and Hold or Pulses)
End Time
Specify end time of graph
Min. Value.
Specify minimum temperature to display on graph
Max. Value.
Specify maximum temperature to display on graph
Report templates can be edited and customized according to specific
needs. For further information refer to section 10.1.2.
Report
Type
Description
Restrictions
Singles
Simple report which displays the
selected test results. One report
will be generated for each test
results.
None
Multiple /
Multiple
grouped by
Patient
A Statistic summary of results
from more than one test.
Test Methods: TSL, Levels, Limits
Selection of 2 or more result files
Bilateral
Compares test statistics for both
sides (left and right) of the same
body site for the same patient.
Test Methods: TSL, Levels, Limits
Selection of 2 result files
Identical Test Subject
Identical Test Program
Identical Main and Specific body site
Opposite body site sides
8. Advanced Options: the advanced options enable you to configure the results which will be
displayed in the report. The following options are available:
Table 22: Report Advanced Options
9.3.1 Analysis Report Types
There are a number of different report templates which can be used to generate a report from
the selected test results. The available report template depends on specific parameters of the
selected report.
The following templates are available:
Table 23: Built-in Report Templates
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