Medoc PATHWAY Product manual

PATHWAY
Pain &Sensory Evaluation
System
Technical Reference
Manual

Pathway Technical Reference Manual
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This User Manual contains proprietary information of Medoc Ltd. and may not be reproduced in
any form without prior written consent from Medoc Ltd.
DC 00054 PATHWAY Technical Reference Manual 26th Ed., October 2018
Medoc Ltd.
1 Ha-Dekel St., PO Box 423 Ramat Yishai 3004627, ISRAEL
Tel.: [phone] / Fax: [phone]
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.: [phone] / Fax: [phone]
E-Mail: [email protected]
European Authorized Representative
CEpartner4U BV
Esdoornlaan 13 3951 DB Maarn, The Netherlands
Phone: [phone] / Fax: [phone]
Mobile: [phone]
E-Mail: [email protected]
This device complies with 93/42/EEC MDD
0473

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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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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:
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
not limited to, the implied warranties of merchantability and fitness for a particular purpose.

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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 60601-
1-2 standard).
1.4 Safety Requirements
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.
1.4.1 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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Hardware protection mechanisms include:
If the Thermode temperature reaches 57C 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
Figure 1: PATHWAY Label 110V
Figure 2: PATHWAY Label 230V
Table 1: Equipment Labels
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

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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