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TSA 2001
Reference Manual
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Medoc TSA 2001 Reference Manual

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Small Fiber Test
Technical Reference
Manual
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This device complies with 93/42/EEC MDD
This User Manual contains proprietary information of Medoc Ltd. and may not be reproduced in
any form without prior written consent from Medoc Ltd.
DC 00076 Q-Sense Technical Reference Manual 12th Edition, Oct. 2018
Medoc Ltd.
1 Ha-Dekel St., PO Box 423 Ramat Yishai 3004627, ISRAEL
Tel.: +972-4-9038800 / Fax: +972-4-9038808
E-Mail [email protected]
www.medoc-web.com
Medoc U.S.A
Compass Medical Technologies, Inc.
1502 West Highway 54 - Suite 404
Durham, North Carolina, 27707, U.S.A
Tel.: +1-(919) 402-9600 / Fax: +1-(919) 402-9607
E-Mail: [email protected]
European Authorized Representative
CEpartner4U BV
Esdoornlaan 13 3951 DB Maarn, The Netherlands
Phone: +31 343 442.524 / Fax: +31 343 442 162
Mobile: +31 6 516 536.26
E-Mail: [email protected]
1282
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Table of Contents
1 Safety Guidelines and Regulations ............................................. 14
1.1 User Manual Icons ....................................................................................... 14
1.2 Intended use ................................................................................................ 15
1.3 Target Population and Contraindications ..................................................... 15
1.4 Safety and Regulatory Summary .................................................................. 15
1.5 Safety Requirements .................................................................................... 16
1.5.1 Warnings ................................................................................................. 16
1.5.2 Cautions .................................................................................................. 17
1.5.3 Equipment Classification ............................................................................ 18
1.6 System Protection ........................................................................................ 18
1.6.1 System Self-Test ...................................................................................... 18
1.6.2 Temperature Safety Mechanisms ................................................................ 18
1.6.3 Thermode Detection .................................................................................. 18
1.7 Equipment Labels, Symbols, Warning Statements and Abbreviations .......... 19
1.8 Electromagnetic immunity ........................................................................... 20
1.9 Recommended Separation Distance between Portable and Mobile RF
Communications Equipment and Q-Sense ............................................................. 24
1.10 Technical Data .......................................................................................... 25
2 Overview .................................................................................... 27
2.1 Training........................................................................................................ 27
2.2 System Description ...................................................................................... 27
2.3 Q-SENSE Thermode ...................................................................................... 27
2.4 Terminology ................................................................................................. 27
2.5 System Status .............................................................................................. 28
2.6 System States .............................................................................................. 28
2.7 Application Methods ..................................................................................... 29
2.7.1 Limits Method ........................................................................................... 29
2.7.2 Levels Method .......................................................................................... 29
2.7.3 Thermal Sensory Limen (TSL) ..................................................................... 29
2.7.4 Ramp & Hold Method ................................................................................. 30
2.7.5 VAS Search Method ................................................................................... 31
2.7.6 Chain Option ............................................................................................ 32
3 System Components ................................................................... 33
3.1 Power side Panel .......................................................................................... 33
3.2 Connectors side panel .................................................................................. 34
4 Setup and Installation ................................................................ 36
4.1 Computer Requirements .............................................................................. 36
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4.2 Installation USB Content .............................................................................. 37
4.3 Setup and Installation Main Steps ................................................................ 37
4.4 Selecting a Location ..................................................................................... 37
4.5 Device Connections ...................................................................................... 38
4.6 Software Installation ................................................................................... 39
4.7 Unit Protection ............................................................................................. 40
4.8 Product Activation ........................................................................................ 40
5 Operation ................................................................................... 42
5.1 Power up Q-SENSE System........................................................................... 42
5.2 Starting Q-SENSE ......................................................................................... 42
5.3 System Self-Test .......................................................................................... 44
5.4 Basic Operation ............................................................................................ 45
5.4.1 Menu Bar ................................................................................................. 46
5.4.2 Toolbar .................................................................................................... 47
5.4.3 Search Row .............................................................................................. 47
5.4.4 Current Selection Information ..................................................................... 48
5.4.5 Data Display Area ..................................................................................... 48
5.4.6 Q-Sense Status Line .................................................................................. 48
6 Test Procedure and Management ............................................... 49
6.1 Selecting a Patient ....................................................................................... 49
6.2 Selecting a Program ..................................................................................... 50
6.3 Selecting a Body Site .................................................................................... 52
6.4 Running the Test .......................................................................................... 53
6.4.1 Test and Post-Test Options ......................................................................... 55
6.4.2 Temperature Graph Display ........................................................................ 56
6.4.3 Test Run Keyboard Shortcuts (Hot Keys) ..................................................... 56
7 Program Management ................................................................ 58
7.1 Program List ................................................................................................ 58
7.2 Creating a New Program .............................................................................. 60
7.3 Removing a Program .................................................................................... 61
7.4 Duplicate A Program .................................................................................... 61
7.5 Edit A Program ............................................................................................. 61
7.6 Program Details ........................................................................................... 61
7.6.1 Limits ...................................................................................................... 62
7.6.2 Levels ...................................................................................................... 66
7.6.3 Thermal Sensory Limen (TSL) ..................................................................... 70
7.6.4 Ramp and Hold ......................................................................................... 73
7.6.5 VAS Search .............................................................................................. 75
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7.6.6 Chaining Programs .................................................................................... 77
7.6.7 Next Sequence Definition ........................................................................... 78
7.7 Standard Events ........................................................................................... 80
7.7.1 Standard Event Configuration ..................................................................... 80
7.7.2 List of Standard Events according to Program Type ....................................... 80
7.8 Test Instructions .......................................................................................... 81
7.9 Import / Export Program ............................................................................. 81
8 Patient Management .................................................................. 83
8.1 Patients List ................................................................................................. 83
8.2 Add New Patient .......................................................................................... 85
8.3 Remove Patient ............................................................................................ 86
8.4 Edit Patient Details ...................................................................................... 86
8.5 Department Management ............................................................................. 86
8.6 ICD 9 Management ....................................................................................... 88
8.7 Import / Export Patient Lists ....................................................................... 88
9 Results Management .................................................................. 90
9.1 Results List .................................................................................................. 90
9.2 Import / Export Results ............................................................................... 92
9.3 Print Results and Reports ............................................................................. 95
9.3.1 Analysis Report Dialog ............................................................................... 95
10 System Configuration ............................................................... 105
10.1 Software Settings ................................................................................... 105
10.1.1 Communication ........................................................................................ 106
10.1.2 Patient Fields ........................................................................................... 106
10.1.3 Results Fields .......................................................................................... 110
10.1.4 Report Options ........................................................................................ 110
10.1.5 User Management .................................................................................... 116
10.2 Hardware Settings .................................................................................. 123
10.2.1 General................................................................................................... 123
10.2.2 Safety .................................................................................................... 124
10.2.3 Thermode ............................................................................................... 124
10.3 Test Settings ........................................................................................... 125
10.3.1 Test Configuration .................................................................................... 125
10.3.2 Instructions Configuration ......................................................................... 129
10.3.3 Body Site Editor ....................................................................................... 131
11 System Information ................................................................. 133
12 The Black box (Logger) ............................................................ 135
12.1 Exporting the Black Box File .................................................................... 135
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13 Appendix A – Normative Data ................................................... 136
13.1 Normative Data License Agreement ........................................................ 136
13.2 Enable Normative Data ........................................................................... 137
13.3 ..................................................................................................................... 139
13.4 Normative Data Editor ............................................................................. 139
13.4.1 Selecting the Normative Data Source (Built-In Tables) .................................. 139
13.4.2 Normative Data Tables ............................................................................. 140
13.5 Display of Normative Data in Tests, Results and Reports ........................ 143
14 Appendix B – Backing Up and Restoring the Database ............. 144
15 Appendix C - Accessories .......................................................... 145
16 Appendix D – System and Module Description .......................... 148
16.1 System Description ................................................................................. 148
17 Appendix E – Preventive and Periodical Maintenance ............... 149
17.1 Periodical System Run and Visual Check ................................................. 149
17.2 Periodical Thermode Calibration ............................................................. 150
17.3 Periodical Thermode Maintenance........................................................... 150
18 Appendix F – Cleaning and Disinfecting .................................... 151
19 Appendix G - Thermode straps assembly instructions .............. 152
20 Appendix H – List of Accompanying Documents ....................... 153
21 Appendix I – Transportation and Storage conditions ................ 154
22 Appendix J – Environmental Conditions ................................... 155
23 Appendix K – Upgrading procedure .......................................... 156
24 Appendix L – Troubleshooting – Operator Level ....................... 158
24.1 Numbered Software Error and Warning Messages .................................. 158
24.1.1 Frequent Warning Messages ...................................................................... 158
24.1.2 Frequent Error Messages ........................................................................... 162
24.2 Faulty System Responses ........................................................................ 171
25 Appendix M – Licensed Options ................................................ 174
25.1 FTP Support ............................................................................................ 174
25.1.1 Export Configuration................................................................................. 174
25.2 CoVAS ..................................................................................................... 176
25.2.1 CoVAS Calibration .................................................................................... 176
25.3 Patient Record Control ............................................................................ 177
25.3.1 Control Patient Field Entry Format with Input Masks ..................................... 177
25.3.2 Add/Remove Patient Fields ........................................................................ 178
25.4 Pain Rating ............................................................................................. 180
25.4.1 Pain Rating Parameters Configuration ......................................................... 180
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26 Appendix N – fMRI functionality ............................................... 182
26.1 fMRI Thermode ....................................................................................... 182
26.1.1 Q-sense system configuration in fMRI mode: ............................................... 182
26.1.2 Installation –MR Filter ............................................................................... 183
26.2 TTL functionality ..................................................................................... 186
26.2.1 Q-sense fMRI side panel ........................................................................... 186
26.2.2 TTL set up ............................................................................................... 186
26.2.3 Standard Event Configuration .................................................................... 187
26.2.4 TTL specifications ..................................................................................... 187
26.3 Blower control......................................................................................... 188
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List of Figures
Figure 1: Q-Sense Label ............................................................................................... 19
Figure 2: Ramp &Hold Sequence – Return to Baseline ...................................................... 30
Figure 3: Ramp & Hold Sequence – Return to Next Destination ......................................... 31
Figure 4: VAS Search – Manual Mode ............................................................................. 31
Figure 5: Power side panel ........................................................................................... 34
Figure 6: Connectors side panel .................................................................................... 34
Figure 7: Q-SENSE System Wiring Schema ..................................................................... 35
Figure 8: Connecting Wall hanger to the wall .................................................................. 38
Figure 9: Q-SENSE System Wiring Schema ..................................................................... 38
Figure 10: DC power port ............................................................................................. 39
Figure 11: Home screen product registration link ............................................................ 41
Figure 12: Q-sense COM port ........................................................................................ 42
Figure 13: Home Screen............................................................................................... 43
Figure 14: Login Screen ............................................................................................... 43
Figure 15: Q-Sense Splash Screen ................................................................................. 43
Figure 16: Self-Test Prompt .......................................................................................... 44
Figure 17: Q-Sense in Rest Mode .................................................................................. 45
Figure 18: Test Navigator – Main Menu .......................................................................... 45
Figure 19: Test Management Main Screen ...................................................................... 49
Figure 20: Patient Selection Menu ................................................................................. 50
Figure 21: Program Selection Menu ............................................................................... 51
Figure 22: Select Body Site screen ................................................................................ 52
Figure 23: Select Body Site – Specific site selection ......................................................... 53
Figure 24: Pre-Test Screen ........................................................................................... 54
Figure 25: Real-Time Test ............................................................................................ 56
Figure 26: Program Management screen ........................................................................ 58
Figure 27: Program Management – Program Preview ....................................................... 59
Figure 28: Program graph preview ................................................................................ 60
Figure 29: New Program Screen .................................................................................... 60
Figure 30: Program Menu – Limits ................................................................................. 63
Figure 31: A Limits Method Test .................................................................................... 65
Figure 32: Statistical analysis of results ......................................................................... 65
Figure 33: Program Menu – Levels ................................................................................ 66
Figure 34: A Levels Method Test.................................................................................... 69
Figure 35: Statistical Analysis of the Results ................................................................... 70
Figure 36: Program Menu – TSL .................................................................................... 70
Figure 37: A TSL Method Test ....................................................................................... 72
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Figure 38: Statistical Analysis of the Results ................................................................... 73
Figure 39: Program Menu – Ramp and Hold .................................................................... 73
Figure 40: Program Editor – VAS Search ........................................................................ 75
Figure 41: Program Chain Editor ................................................................................... 77
Figure 42: Program Editor Next Sequence Definition ........................................................ 79
Figure 43: Manual Next Sequence definition ................................................................... 79
Figure 44: Standard Events in Program Editor ................................................................. 80
Figure 45: Test Instructions Editor ................................................................................. 81
Figure 46: Patients List ................................................................................................ 83
Figure 47: Patient Management – Patient details preview ................................................. 84
Figure 48: Patients Editor Screen .................................................................................. 85
Figure 49: Edit Department Menu .................................................................................. 87
Figure 50: Edit ICD Menu ............................................................................................. 88
Figure 51: Results List ................................................................................................. 90
Figure 52: Result preview display .................................................................................. 91
Figure 53: Export Result File Opened In Excel – Description Tab Sample ............................ 93
Figure 54: Export Result File Opened In Excel – Data Tab Sample ..................................... 93
Figure 55: Analysis Reports Dialog ................................................................................ 95
Figure 56: Analysis Report ............................................................................................ 96
Figure 57: Single Results Report ................................................................................... 98
Figure 58: Multiple Results Report ................................................................................. 98
Figure 59: Site to Site Results Report ........................................................................... 100
Figure 60: Pre / Post Results Report ............................................................................. 100
Figure 61: Trend Results Report ................................................................................... 100
Figure 62: Custom Report Results ................................................................................ 100
Figure 63: Bilateral Results Report ............................................................................... 101
Figure 64: Custom Report Configuration ........................................................................ 103
Figure 65: Custom Report Configuration ........................................................................ 104
Figure 66: Custom Report Configuration ........................................................................ 104
Figure 67: Software Settings Dialog .............................................................................. 105
Figure 68: Open Software Settings ............................................................................... 106
Figure 69: Software Settings - Patient Fields tab selection ............................................... 106
Figure 70: Software Settings - Patient Fields .................................................................. 107
Figure 71: Results Fields Configuration Screen ............................................................... 110
Figure 72: Report Options tab ...................................................................................... 111
Figure 73: Detailed Report example .............................................................................. 112
Figure 74: Detailed Report Options ............................................................................... 113
Figure 75: Custom made Report Name dialog ................................................................ 114
Figure 76: Report Editor Screen ................................................................................... 115
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Figure 77: Open Software Settings ............................................................................... 116
Figure 78: Software settings users tab selection ............................................................. 116
Figure 79: Software Settings Users Tab ......................................................................... 116
Figure 80: Software Settings Add New User ................................................................... 117
Figure 81: Software settings filled ................................................................................ 118
Figure 82: Hardware settings – General tab ................................................................... 123
Figure 83: Hardware settings – Safety tab ..................................................................... 124
Figure 84: Hardware settings – Thermode tab ................................................................ 125
Figure 85: Test Configuration Settings .......................................................................... 126
Figure 86: Instructions Configuration ............................................................................ 129
Figure 87: Test Instructions Editor ................................................................................ 130
Figure 88: Audio save button ....................................................................................... 130
Figure 89: Body Sites Editor ........................................................................................ 131
Figure 90: System Information .................................................................................... 133
Figure 91: Sysinfo File Sample ..................................................................................... 134
Figure 92: Black Box – Software .................................................................................. 135
Figure 93: Normative Data Editor - Enable Normative Data ............................................. 137
Figure 94: Normative Data License Agreement ............................................................... 138
Figure 95: Normative Data Editor - Learn More .............................................................. 139
Figure 96: Normative Data screen select source ............................................................. 140
Figure 97: Normative Data Editor ................................................................................. 141
Figure 98: Database Utility – Backup/Restore Menu ........................................................ 144
Figure 99: System Diagram ......................................................................................... 148
Figure 100: Previous version message .......................................................................... 156
Figure 101: Removing previos version screen ................................................................ 156
Figure 102: Data Backup Path ...................................................................................... 156
Figure 103: MMS Uninstall ........................................................................................... 157
Figure 104: Uninstall Completed .................................................................................. 157
Figure 105: MMS successfully removed ......................................................................... 157
Figure 106: Error and Warning Messages Sample ........................................................... 158
Figure 107: Open Software Settings ............................................................................. 174
Figure 108: Software settings export tab selection ......................................................... 174
Figure 109: Software Settings Export Tab ..................................................................... 175
Figure 110: CoVAS Calibration Tab ............................................................................... 176
Figure 111: Patient Fields with Input Masks ................................................................... 179
Figure 112: Patient Card with Selected Patient Fields ...................................................... 179
Figure 113: Pain Rating Parameters .............................................................................. 180
Figure 114: Pain Rating Limits ..................................................................................... 181
Figure 115: fMRI room setup ....................................................................................... 184
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Figure 116: Q-sense fMRI Thermode Control Room part WA 00281 .................................. 184
Figure 117: Q-sense fMRI Thermode Shielded room part AS 00412 .................................. 185
Figure 118: Q-sense fMRI side panel ............................................................................. 186
Figure 119: HW settings for Q-sense fMRI ..................................................................... 186
Figure 120: Standard Events in Program Editor .............................................................. 187
Figure 121: Standard Event Editor ................................................................................ 187
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List of Tables
Table 1: Equipment Labels ........................................................................................... 19
Table 2: Q-SENSE Specifications ................................................................................... 25
Table 3: Terminology ................................................................................................... 27
Table 4: Q-SENSE Connectors side Panel receptacles ....................................................... 33
Table 5: Connectors to power side panel ........................................................................ 33
Table 6: Menu Bar options ............................................................................................ 46
Table 7: Status line parameters .................................................................................... 48
Table 8: Test Run options ............................................................................................. 55
Table 9: Hot Keys ........................................................................................................ 56
Table 10: Probe Type options ........................................................................................ 60
Table 11: Program Details ............................................................................................ 63
Table 12: Program Parameters ...................................................................................... 64
Table 13: Program Details ............................................................................................ 67
Table 14: Program Parameters ...................................................................................... 67
Table 15: Program Details ............................................................................................ 71
Table 16: Program Parameters ...................................................................................... 71
Table 17: Program Parameters ...................................................................................... 74
Table 18: Program Parameters ...................................................................................... 75
Table 19: Chain sub program parameters ....................................................................... 77
Table 20: Program Details ............................................................................................ 77
Table 21: Program Table .............................................................................................. 78
Table 22: List of standard events according to program type ............................................ 80
Table 23: Report Analysis Configuration ......................................................................... 96
Table 24: Report Analysis Configuration ........................................................................ 101
Table 25: Software Settings - General .......................................................................... 106
Table 26: Patient’s Field .............................................................................................. 110
Table 27: Report Options ............................................................................................ 111
Table 28: Report Options ............................................................................................ 113
Table 29: Authorization Levels (main actions) ................................................................ 119
Table 30: Hardware Settings Tab Sheets ....................................................................... 123
Table 31: Hardware Settings – General tab options ........................................................ 123
Table 32: Pre-test parameters ..................................................................................... 126
Table 33: Test configuration parameters ....................................................................... 126
Table 34: Post-test parameters .................................................................................... 127
Table 35: Test Display configuration ............................................................................. 127
Table 36: Temperature Scale Configuration ................................................................... 127
Table 37: Temperature Limits ...................................................................................... 128
Table 38: Normative Data Fields .................................................................................. 141
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Table 39: Accessories ................................................................................................. 145
Table 40: Q-sense Accompanying Documents ................................................................ 153
Table 41: Warnings .................................................................................................... 158
Table 42: Errors ......................................................................................................... 162
Table 43: Faulty System Responses .............................................................................. 171
Table 44: Regular Characters ....................................................................................... 177
Table 45: Special Characters ....................................................................................... 177
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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.
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. The manual and software are available in English.
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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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.
1.2 Intended use
The Q-Sense is a device for quantitative thermo-testing in the context of quantitative sensory testing battery in compliance with Quantitative Sensory Testing (QST) protocols to detect and quantify sensory loss and sensory gain aimed to precisely characterize somatosensory function in patients.
1.3 Target Population and Contraindications
The Q-Sense can be used on both healthy subjects and patients suffering from wide range of neuropathic, CNS and pain conditions. Minimum age reported in the literature is 6.
The only known contraindication is related to the skin on which the thermode is applied – it must be used in contact with intact skin only. The thermode also intended to be applied on the skin only, not on the eyes and the mouth.
1.4 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 Q-SENSE system complies with safety requirements for medical electrical systems
(based on the IEC 60601-1 standard).
The Q-SENSE system complies with electromagnetic emission levels (based on table
201 in the IEC 60601-1-2 standard).
The Q-SENSE 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 recommended to keep a distance of 3 meters between portable and mobile RF
communications equipment and the Q-SENSE (based on table 206 in the IEC 60601-1­2 standard).
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The Q-SENSE 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 Q-SENSE system. Connecting or replacing external Q-SENSE accessories is allowed.
No modification of this equipment is allowed.
To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth
Keep all liquids away from the Q-SENSE system. Unplug the Q-SENSE system if it is not to be used for a long period of time. Do not block airflow anywhere around the Q-SENSE system.
1.5 Safety Requirements
1.5.1 Warnings
Only personnel properly trained to operate the Q-SENSE system should use this
system.
Do not turn on system power until all cables have been properly connected and
verified.
To avoid the risk of electric shock, this equipment must only be connected to a supply
mains with protective earth
Do not use any power supply which not supplied by Medoc (Medoc’s power supply
Cat.# DT 00017).
Do not use any electrode paste, gel, or other materials on the contact point between
the Thermode plate and the skin of the tested subject.
To reduce the risk of injury, place the Thermode on the subject only before starting the
test and while the test screen is visible. After the test is complete, remove the Thermode from the subject’s skin while the test screen is still visible.
Connect the Thermode to the patient's skin ONLY during the test; not during system
Self-Test, programming or maintenance.
The computer that is used to operate the Q-SENSE system must be powered through a
Medical Grade Isolation Transformer only.
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 Q-
SENSE system is not allowed.
Using a Thermode without the appropriate calibration table may result in potential
harm or injury.
Using the Q-SENSE system not according to instructions may result in potential harm
or injury.
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been reported with the use of a stimulator, which was based on similar technology as the Q-Sense 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.
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 [ME EQUIPMENT or ME SYSTEM], 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 re­orienting the equipment
1.5.2 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).
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.
Inspect the power cord often for fraying or other damage. DO NOT operate the
apparatus if the power cord or plug is damaged.
The computer that is used to operate the Q-SENSE system must not be connected to a
network while it is used for running tests.
The Q-SENSE system does not require special precautions regarding EMC, and needs
to be installed and put into service according to this manual.
Portable and mobile RF communications equipment can affect medical electrical
equipment.
Use caution when using the Q-SENSE 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.
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1.5.3 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.
1.6 System Protection
1.6.1 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.
1.6.2 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.
Hardware protection mechanisms include:
If the Thermode temperature reaches 57C an analog circuit overrides the system and
lowers the temperature gradually.
1.6.3 Thermode Detection
The system automatically detects that a Thermode is missing, and disables it in order to protect both system and user.
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Equipment Label
Description
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
Disposal according to electronic scrap ordinance
I
1.7 Equipment Labels, Symbols, Warning Statements and
Abbreviations
Figure 1: Q-Sense Label
Table 1: Equipment Labels
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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
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic
environment –guidance
Electrostatic discharge (ESD) IEC 61000-4-2
±6 kV contact ±8 kV air
±6 kV contact ±8 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Power frequency (50/60 Hz) magnetic field
IEC 61000-4-4
3 A/m 50 & 60 Hz
3 A/m 50 & 60 Hz
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Electrical fast transient/burst IEC 61000-4-4
±2 kV for power supply lines
±2 kV for power supply lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5
±1 kV line(s) and neutral
±1 kV line(s) and neutral
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
<5 % UT (>95 % dip in
UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT
<5 % UT (>95 % dip in
UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles) <5 % UT
Mains power quality should be that of a typical commercial or hospital environment. If a dip or an interruption of mains power occurs, the current of the Q­sense may be dropped off from normal level, it may be necessary to use uninterruptible power supply or a battery.
1.8 Electromagnetic immunity
The Q-Sense is intended for use in the electromagnetic environment specified below. The customer or the user of the Q-Sense should assure that it is used in such an environment.
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(>95 % dip in UT)
for 5s
(>95 % dip in UT) for 5s
NOTE UT is the a.c. mains voltage prior to application of the test level
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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
3V from
0.15 to 80MHz; 6V from
0.15 to 80MHz and
80% AM at 1kHz
10V/m from 80MHz
to 2.7GHz
3Vrms, 6V
3V/m
3V from 0.15 to
80MHz; 6V from 0.15
to 80MHz and
80% AM at 1kHz
10V/m from 80MHz
to 2.7GHz
Portable and mobile RF communications equipment should be used no closer to any part of the Q-sense, 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 metres (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.
D Interference may occur in the vicinity of equipment marked with the following symbol:
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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 Q-Sense is used exceeds the applicable RF compliance level above, the Q-Sense should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Q-Sense. ** Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Declaration – electromagnetic emissions
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions CISPR 11
Group1 Class A
The Q-sense 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 Q-sense 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 Q-sense or shielding the location.
Voltage Fluctuations And Flicker IEC 61000-3-3:2013
Complies
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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.
1.9 Recommended Separation Distance between Portable
and Mobile RF Communications Equipment and Q-Sense
The Q-Sense is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Q-Sense can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Q-Sense 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
Parameter
Specification
Thermode Active Area
30x30 mm Thermode temperature Range
20 – 50 °C Heating Rate
0 – 2 °C/Sec ± 10% Cooling Rate
0 - 1 °C/Sec ± 10%
Stimulation Methods
Limits, Levels & TSL Ramp & Hold (optional)
Set-Point Resolution
0.1 °C Display Resolution
0.1 °C Repeatability
± 0.3 °C Absolute Accuracy
±0.3 °C
Operating Mode
Intervals* *(Short pause between patients may be required)
Minimum Inter Stimuli Interval (ISI)
2 sec Maximum Consecutive Stimuli
10 Baseline Thermode Temperature Range
28 – 40 °C
Programmable Parameters
Method, Adaptation Temperature, Heating Rate, Cooling Rate, Number of Stimuli, ISI, Sound Option, Randomize Option
Communication with PC
USB Communication with Printer
Via PC Standards
IEC 60601-1; IEC 60601-1-2 Approvals
CE, FDA Operating Voltage
12 VDC, 5A Power Supply
100 – 240 VAC, 4 – 2 A, 50/60 Hz Power Consumption
Approx. 60W
Dimensions
31cm X 28 cm X 16cm (table or wall mount) Shipping: 53cm X 34cm X 22cm
Weight
Approx. 4.5 Kg Shipping: Approx. 10 Kg
Software
Propriety Software Application (Included)
Computer Requirements (PC not included)
Notebook PC (Atom CPU not supported) At least 2 GB RAM, 6 GB Free disc space. Windows 7/8 (32 & 64 bit), Windows XP (32bit) sp. 3 and above.
1.10 Technical Data
The table below describes the technical specifications and capabilities of the Q-Sense system.
Table 2: Q-SENSE Specifications
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Parameter
Specification
Screen Resolution
1366X768 and higher Patient Response Unit
2 buttons (Yes / No) Response Unit Product life time
10 years Thermode life time
1 year
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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.
Rest Temperature
The initial/rest temperature of the Thermode, after system initialization and in between tests. Also referred to as Adaptation Temperature.
2 Overview
The Q-Sense Thermal Sensory Analyzer is a QST (Quantitative Sensory Testing) device including advanced software package designed for clinical use and research in the field of Pain Management.
2.1 Training
Users of Q-Sense shall have received adequate training on its safe and effective use before attempting to work with it. Training requirements may vary from country to country. The User shall make sure that training is received in accordance with local laws or regulations that have the force of law. Information on training is available from your local Medoc representative.
2.2 System Description
The Q-Sense is a TSA 2001 model, which enables the user to perform various thermal test paradigms including the method of Limits, Levels, and TSL. These test paradigms can be utilized for a wide range of thermal QST pain measures such as thermal pain threshold and tolerance.
Intended use: The Q-Sense is a pain management and pain research intended to be used for the quantitative assessment of small nerve fiber dysfunctions. It measures sensory thresholds such as the cold and warm sensation, and heat-induced pain.
2.3 Q-SENSE Thermode
The Thermode is the active component of the system which delivers the actual stimulus. The main components of the Q-Sense Thermode include:
Active Thermal Element – The active Thermal element is a Thermoelectric Cooler
(TEC), a peltier element, which generates a temperature gradient according to the direction and amplitude of power (electrical current) it is given.
Temperature Sensors (Thermistors) - The Thermistors are resistors which change their
resistance with temperature. Two thermistors are used to sense the slightest change in temperature and deliver feedback to the temperature control unit. The temperature control unit adjusts the power output to this feedback.
Contact Plate – Contact plate is the external area of the Thermode which comes in
contact with the skin of the tested subject. The plate is aluminum coated for heat dispersion.
Cooling Elements – The cooling elements disperse heat from the TEC For more detailed specifications of the Q-Sense please refer to the Technical Specifications in
section 1.10, page 25
2.4 Terminology
The following terms are used throughout this manual:
Table 3: Terminology
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Term
Description
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
Trial
Represents one stimulus
Sequence
A set of trials with the same specifications
Test
A set of sequences.
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.
Firmware
The program embedded on the internal processor of the system
2.5 System Status
Online: This is the Q-SENSE system full operating mode and indicates full
communication between MEDOC Main Station and Q-Sense System. While on-line the Q-Sense system can operate in several different states as listed in the following section.
Demo Mode: This is a demo mode of operation. There is no communication between
the software and the Q-SENSE system. All tests performed while working in this mode are simulated. No actual thermal stimulation is performed and there is no access to the Q-SENSE 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 Q-SENSE system while working in Simulator mode.
2.6 System States
System State is the active state in which the system is currently operating. System states refer to the online status only.
The Q-SENSE active states are as follows: Rest Mode: The Q-SENSE system is active and ready to perform a test. The
temperature is maintained at the specified Rest Mode temperature. In this mode, patient, program and result management are possible.
Test Run: The Q-SENSE system is running a (predefined) test. The Thermode is
active, and the temperature varies according to the active program.
Safe Mode: No test can be performed and safety mechanisms are activated. The
system must perform a Self-Test before resuming normal operation.
Engineering: During Thermode Calibration the system state is set to Engineering. In
this state safety limitations are lowered and it is not allowed to run any actual tests.
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
Thermode is functioning according to system requirements.
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Before using each of these methods, make sure you have read section 6, Page 49, Test Procedure and Management, which addresses the following topics: Tested subject selection, Program selection, and Stimuli administration.
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.
2.7 Application Methods
Method is the type of the test program. Q-SENSE supports the following methods: Limits: A set of predetermined stimuli is emitted, and for each stimulus, the tested
subject is required to respond (stop the stimulus) when perceiving a predefined sensation. For more details refer to section 2.7.1.
Levels: A set of stimuli is emitted, and for each stimulus, the subject is required to
respond. The following stimulus is calculated according to the subject's response. For more details, refer to section 2.7.2.
Thermal Sensory Limen (TSL): The temperature direction changes according to the
subject's response, alternating between increasing temperature and decreasing temperature. For more details, refer to section 2.7.3.
Ramp & Hold (optional, available with specific license): The temperature of the
stimulus is maintained for a predetermined duration.
VAS Search (optional, available with specific license): 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.
2.7.1 Limits Method
This reaction time inclusive method consists 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.
For detailed information refer to section 7.6.1, page 62.
2.7.2 Levels Method
In the Levels method, stimuli are increased by a predetermined initial step until the first YES response. Stimuli 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 is halved at every direction change. The test is terminated when the step reaches a small enough size, as pre-determined by the user. Threshold is determined by taking the mean of last YES and the last NO. This is the shortest of all constant stimuli methods.
A modified Levels method allows you to hold Temperature for predefined Time at destination. For detailed information refer to section 7.6.2, page 66.
2.7.3 Thermal Sensory Limen (TSL)
The TSL is another reaction time dependent method is the detection of Thermal Sensory Limen (T.S.L.). In this algorithm, once started, the stimulus temperature does not stop at
adaptation, rather, it 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
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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
thermal sensation is calculated as the difference between means of cold-sensation and warm-
sensation. Using the TSL method, allows the Limen or ‘no thermal sensation’ area to be
calculated. For detailed information refer to section 7.6.3, page 70.
2.7.4 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.
“Return to Baseline” option
The diagram below shows a general view of the sequence and predefined parameters. For the definition of each parameter, see 7.6.4, page 73.
Figure 2: 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
3. Then, the temperature remains at the destination temperature level for the predefined
predefined Destination Temperature.
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.
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Temperature
Time
Destination
Temperature 1
Sequence 1
Sequence 2
Destination
Temperature 2
Onset
“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 7.6.4, page 73.
Figure 3: Ramp & Hold Sequence – Return to Next Destination
2.7.5 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:
Figure 4: VAS Search – Manual Mode
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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 7.6.5, page 75 for full description of program details and parameters.
2.7.6 Chain Option
The chain option enables to chain any of the above methods, any number of times, in any order.
For detailed information refer to section 7.6.6, page 77.
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#
Description
Mate with
1
Q-sense Thermode Main receptacle Blue – power connector Green – Sensor connector
2
Response Unit receptacle Use for recording patient response during test
1
Power Supply Power supply is used to connect electricity port and to the power port in the Q-sense system.
2
Communication USB Cable This cable is used to connect the Q-sense com port with a computer.
3 System Components
Q-SENSE components contain the following receptacles and controls:
Table 4: Q-SENSE Connectors side Panel receptacles
Table 5: Connectors to power side panel
3.1 Power side Panel
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Power switch
Power supply
Communication port
receptacle
Main receptacles
Figure 5: Power side panel
3.2 Connectors side panel
Q-sense Thermode
Response Unit
Figure 6: Connectors side panel
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Figure 7: Q-SENSE System Wiring Schema
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Complete and verify the entire Q-Sense setup and installation process before the using the system
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 (Not recommended: Windows XP service pack 3. Please see note below)
Other
Microsoft Office 2007 or above (required for viewing results in excel)
The following Medoc Main Station updates will no longer support Windows XP. Please avoid using Windows XP operating system if possible.
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 Q-SENSE system installation is designed to be simple and fast. Follow the instructions given below for selecting a location, installing and initial. 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 Q-Sense Technical Reference Service Manual for further details on the system components.
Different type of walls requires different masonry anchors.
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. Technical Reference Manual.
4. Technical Reference Service Manual.
5. Remote assistance tools.
4.3 Setup and Installation Main Steps
The assembly procedure consists of the following steps:
1. Selecting a location for the system. See section 4.4, page 37.
2. Connecting the Thermode and any additional accessories to the system. See section 4.5,
page 38.
3. Connecting the laptop and installing the MEDOC Main Station software. See section 04.6,
page 39.
4. Configuring the system.
4.4 Selecting a Location
An appropriate location for the Q-SENSE system should meet the following criteria:
1. The room temperature should be kept between 18°C and 24°C.
2. The Q-Sense system should not be placed in a location, which is exposed to direct sunlight
or constant vibrations, or close to heaters or air conditioners.
3. The space allocated for the system should allow enough room to perform regular system
maintenance procedures.
4. The room in which the system will be located should be quiet, allowing the tested subject
to concentrate on the examination with minimum distractions.
5. It is possible to hang the Q-Sense system using Medoc Wall Hanger. To hang the system:
Connect Medoc Wall Hanger to the specific site on the wall.
5.1. Mark the screw’s holes on the wall, and take the hanger off the wall.
5.2. Use a 6 mm drill bit to create holes on the wall in the points you marked in b section.
5.3. Insert masonry anchors to the drilled holes.
5.4. Connect the hanger by screwing the attached screws to the masonry anchors.
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Do NOT connect the USB cable to the Q-SENSE system before complete installation of the MEDOC Main Station software.
Figure 8: Connecting Wall hanger to the wall
4.5 Device Connections
1. Ensure that the laptop meets the requirements set by Medoc (See section 4.1, page 36).
2. Make sure that your Laptop, Q-SENSE unit and printer (optional) are all OFF.
3. Connect the system, Thermodes and accessories. See Figure 9
Figure 9: Q-SENSE System Wiring Schema
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Thermode and Response Unit connectors are color coded.
The Response Unit plug should be connected to yellow receptacle. The Thermode green and blue plugs should be connected to the green
and blue receptacles respectively.
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 Q-SENSE system that has not been specifically authorized and approved by Medoc.
Depending on the current configuration of the computer, 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.
DC Power Port
Figure 10: DC power port
4. Connect the Q-SENSE power supply to an AC outlet and the cable to the DC power port.
4.6 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 upgrading instructions in section 23, page 156.
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 Q-SENSE system. Unplug the power supply of the Q-SENSE system from electricity if it
is not to be used for a long period of time.
Do not block airflow anywhere around the Q-SENSE system and
Thermode.
When all setup and installation procedures have been completed you may 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.
4.7 Unit Protection
4.8 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 11.
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If at any point during the product activation process you encounter any difficulties please contact Medoc support at [email protected] for assistance.
Figure 11: Home screen product registration link
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Make sure that all communication and power cables, accessories and Thermode are properly connected to the system!
It is not allowed to connect the Q-Sense computer to a network while running tests with the system!
Before initializing the Q-SENSE system, ensure that the Thermode is connected correctly.
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.
Communication port
5 Operation
The purpose of the following chapters is to specify the Q-SENSE applications and to bring in­detail step-by-step instructions for conducting thermal stimuli.
This chapter specifies Q-SENSE behavior at start up and MEDOC Main Station basic components.
5.1 Power up Q-SENSE System
1. Connect your PC using USB cable to the COM connection, communication port, at the side
of the Q-SENSE system.
Figure 12: Q-sense COM port
2. Power up the Q-SENSE system by using the main switch on the side of the Q-SENSE.
5.2 Starting Q-SENSE
1. Turn ON the Q-SENSE unit, by using the main power switch
2. Turn ON the laptop
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 10.1.5
Figure 13: Home Screen
5. To select Q-Sense, click on the Q-Sense image.
6. When the login screen is displayed, enter your user name and password and select "Q-
SENSE" in the "connect to" field.
Figure 14: Login Screen
7. While the software is establishing communication with the device the following screen may
be displayed:
Figure 15: Q-Sense Splash Screen
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Make sure that Thermode is not attached to human subject before self­test is complete.
8. When communication is established, the system will enter SAFE MODE and remain in this
state until completing the system Self-Test, see section 5.3 below. Make sure the Thermode is not attached to the Subject and click on OK on the following message:
5.3 System Self-Test
Upon system start up, Q-SENSE will automatically enter SAFE MODE state. 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.
System self-test must be completed successfully before Q-SENSE can be used. The following message prompting for system self-test is displayed. Make sure the Thermode is not attached to a patient and click OK.
Figure 16: Self-Test Prompt
The system will perform a complete self-test of all enabled Thermodes according to your system settings.
After self-test has completed successfully, Q-SENSE State will change to Rest Mode.
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Menu Bar
Toolbar
Area
Search Row
Information
Figure 17: Q-Sense in Rest Mode
5.4 Basic Operation
As soon as the self-test is successfully completed the TEST screen is displayed:
Current Selection
Data Display
Figure 18: Test Navigator – Main Menu
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Note that the status line also indicates the type and model of the Thermode, you are currently applying to (see red circle, above).
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 Tests Results to MS Excel format, for data analysis.
Print
Print Test Results as a Report (enabled in the Results screen). Refer to section 9.3 for further information.
Logoff
Log off and switch users without exiting the software or shutting down Q-SENSE.
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.
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 Data Display Area – View list of patients, programs or body sites Status Line – Continues real-time display of Q-SENSE status and Thermode
temperature. The components are detailed in the following sections.
5.4.1 Menu Bar
The Menu bar consists of the following options:
Table 6: Menu Bar options
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Menu
Option
Description
Results
Switch to Results screen to view and manage saved test results.
Settings
Software settings
MEDOC software related configuration and preferences.
Hardware settings
Q-SENSE system and Thermode hardware configuration and management.
Test settings
Test configuration and display preferences
Status
Status configuration- On line\Demo.
Utilities
Department
Add/Remove Departments for patient list management.
ICD 9
Add/Remove ICD 9 codes.
Normative Data
Normative Data database and Editor. Black box
System hardware and software logs
Device recovery
Initiate Q-SENSE system self-test in case safety was triggered.
Log Files
View software log files
Probe Files
Import or export the termode calibration details.
Help
Operating Manual
Link to the Q-SENSE Technical Reference Manual
Service Manual
Link to the Q-SENSE Technical Reference Service Manual About …
System and software information
Service Call
Submit a Service Call via Medoc web site*.
FAQ
FAQ on Medoc web site*. *internet connection required
5.4.2 Toolbar
The Toolbar consists of shortcuts to the different views:
Test Navigator – Select test parameters Patients View – Manage patient database Programs – Manage program list Results – View, export or print test results
5.4.3 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.
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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 connected to the system: Q-sense 30x30mm.
TEC
Temperature of the Thermode.
HS1/HS2
Temperature of heat-sink (cooling element)
Fan Mode
Indicates the Fan mode.
Safety
Safety status. A green indicator is displayed for OK and a red indicator for Safe Mode activation – Thermode is disconnected from input. System remains non-functional, until malfunction is resolved.
5.4.4 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 Thermode.
5.4.5 Data Display Area
Displays list of data which is relevant to the current screen.
5.4.6 Q-Sense 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
7.
Table 7: Status line parameters
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Make sure you are familiar with the stimulation method before you start with 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.
Test tab highlighted
Test Navigator
6 Test Procedure and Management
Starting a test procedure is only possible from the Test Navigator screen
Figure 19: Test Management Main Screen
The stimulation procedure (test) consists of the following main steps:
Select Patient – Select the tested subject’s file from the database. Select Program – Select the relevant program that will be used for the test. Select Body Site – Select the body site and its details for the current test. This step is
optional.
Go to Test and 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.
6.1 Selecting a Patient
1. Click the Select Patient button on the Test Navigator
2. Use the Search Row (see section 5.4.3 above) to filter and sort list in order to find the
relevant patient entry.
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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 83).
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 Button
Figure 20: 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. Click the Hide Details button to view the patients list only.
6. Click the Clear button to clear Current Test information if required.
7. Proceed to the Selecting a Program section.
6.2 Selecting a Program
1. Click the Select Program button on the Test Navigator
2. Use the Search Row (see section 5.4.3 above) to filter and sort list in order to find the
relevant patient entry.
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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.
Display program details.
Display program graph preview. Available on selected methods.
View selected test instructions.
View recent program modification dates.
Program details can only be viewed from the Test screen. For editing, refer to Program Management section (section 7, page 58).
Search Row
Show/Hide Details Button
Figure 21: 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 patient details, click on the Show Details button.
5. The following options are available in the program details view:
6. Click the Hide Details button to view the program list only.
7. Click on the Clear button to clear current selection if required.
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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.
8. Proceed to the Selecting Body Site section if you want to select site for the specific test,
or click Go to Test in order to run the test without specific body site selection.
6.3 Selecting a Body Site
Selecting a tested body site 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 22: Select Body Site screen
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 Patient and a Program before you try to proceed with an actual test.
Figure 23: 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 the Go to Test button
The following screen is displayed:
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At this point attach the Thermode to the tested subject. Caution! DO NOT use any electrode paste, jell or other material on the
contact point between the Thermode and the tested subject's skin.
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.
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.
The system will prompt you to save the stimulation data before starting a test or exiting the current session.
Figure 24: Pre-Test Screen
2. Click the Start Pre-test button ( ).
The system performs a short pre-test, and stabilizes on the Baseline temperature.
3. After a successful pre-test, the Pre-test button is replaced by a Test Run button ( )
4. Click the Start button ( ).
5. To pause the stimulation, click the pause button ( ).
6. To stop the stimulation, click 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 on the Save button to save the test results and stimulation data.
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After concluding a stimulation session, always clean the Thermode contact plate. For further details, refer to section 18, page 151.
Do NOT immerse the Thermode in any kind of liquid.
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 10.3.2.1
Play audio test instructions for the subject. To assign an audio file with default instructions, refer to section 10.3.2.2.
Automatic zoom along the temperature axis. The temperature axis scale expands according to the highest and lowest temperatures displayed on screen. Button is located at the bottom left of the graph. Alternatively, change zoom manually by using the +/- buttons.
Reset zoom to the original (default) scale. Button is located at the bottom left of the graph.
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 up/down arrows or type the value in the box.
Return back to the test screen to start a new test with or without clearing certain test details such subject and program.
Last test results are not saved automatically.
Indicate positive subject response in Limits, Levels, and TSL protocols.
Indicates negative subject response in Limits, Levels, and TSL 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.
6.4.1 Test and Post-Test Options
Table 8: Test Run options
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Button
Key
Action
S
Can be used instead of the Stop button to finalize; then stop the test.
Baseline Temperature
Baseline
Statistic
Temperature
6.4.2 Temperature Graph Display
During the test, the test graph is generated and displayed on the screen. Following is an example:
Baseline
Figure 25: Real-Time Test
The+ following information is displayed:
9. Stimuli display (including CoVAS and events where applicable)
10. Current probe and program details.
11. Current sequence and trial data
12. Legend
13. Axes labels: Temperature axis on the left and CoVAS on the right (where applicable)
14. 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.
15. 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.
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. The table below describes the available options.
Table 9: Hot Keys
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Button
Key
Action
/
/ /
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.
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.
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The more criteria you define using the filter, the shorter the list that will be displayed.
It is possible to change column order by drag and drop it to required place.
Create a new program
Duplicate selected program
Delete selected program
Edit selected program
7 Program Management
This chapter describes how to manage your stimulation programs. Programs can be created, duplicated or removed from the database. Following are the detailed individual parameters for program.
7.1 Program List
The Program screen enables you to manage programs (add, remove, edit etc.).
1. To access the program database, click the Programs button at the toolbar. The following
screen is displayed:
Figure 26: Program Management screen
2. To narrow down the displayed list use the filter row.
3. To clear the filtered list, select the (All) option from the filter drop down list.
The following options are available in the Program Management screen:
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or
Show or Hide program preview Display program details.
Display program graph preview. Available on selected methods.
View selected test instructions.
View recent program modification dates.
Program details cannot be edited from the preview screen.
Current Selection control - displays the selected program information. Current Thermode control - displays the Thermode that is used for the selected program.
When you open the Program Preview bar, the following screen is displayed:
Figure 27: Program Management – Program Preview
The following options are available in the Program Preview:
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Parameter
Description
Q-sense
Can operate with one of the following methods: Levels, Limits, TSL, Ramp & Hold (optional, license is needed), Chain.
Figure 28: Program graph preview
7.2 Creating a New Program
To create a new program, perform the following procedure:
1. From the Programs screen, click the Create New Program ( ) icon.
The following dialog is displayed:
Figure 29: New Program Screen
2. In the Probe Type drop-down list, select the Q-sense probe. The following options are
available (in accordance with your licensing agreement):
Table 10: Probe Type options
3. From the Method drop-down list, select the required stimulation method (Limits, Levels TSL
or Chain).
4. Type the program name.
For faster identification, it is advisable to type a meaningful name.
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Displays a list of the program revision history by version date and username.
5. Click OK.
The Program Details screen is displayed (see below).
7.3 Removing a Program
To remove a program from the program list:
9. Click the Remove icon ( ).
10. Click Yes to the prompt.
The selected program is deleted.
7.4 Duplicate A Program
To duplicate a program from the program list:
1. Click the Duplicate icon ( ).
2. The selected program was duplicated and given a unique name automatically (the name is
editable).
7.5 Edit A Program
To edit a program from the program list:
1. Click the Edit icon ( ).
2. The selected program details screen is open and can be edited.
7.6 Program Details
The following screens enable the formation of program protocols. There are two test types: Programmed – the Thermode temperature varies according to the program parameters. Manual – the Thermode temperature varies according to selected accessory. Following are sampled menus:
Limits Levels TSL Ramp and Hold (optional) VAS Search (optional) Chain
The following functions are available in the program menus:
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Displays the Test Instructions Editor for editing test instructions. Refer to section 7.8, page X80.
Returns to the previous menu.
Copies the selected record (sequence). Not available in Levels, TSL and Chaining programs.
Pastes the copied record to the right of the selected record. Not available in Levels, TSL and Chaining programs.
Adds a new record to the end of the current program. Not available in Levels, TSL and Chaining programs.
Adds a new record to the left of the selected record. Not available in Levels, TSL and Chaining programs.
Previews the program graph.
Checks program validity, and marks missing or incorrect parameters.
Saves the information displayed.
7.6.1 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 method explanation, refer to section 2.7.1, page X29.
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When adding or editing programs, follow these rules:
Enter meaningful information in the Program Description section of the screen.
Define all the parameters of a sequence for that sequence to be valid.
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 identified by an icon that flashes next to the relevant field. A short description of the malfunction can be displayed by holding the cursor over the
relevant icon.
Parameter
Description
Program name
The program name (editable).
Probe
The probes used with this program.
Description
Under Description, click the arrow ; then type free text to describe the program. The Description icon is indicated as active ( ).
Figure 30: Program Menu – Limits
The program menu varies according to the probe, and the method of stimuli intended for use, as shown on the left side of the screen.
The parameters available for program creation at this stage are as follows:
Table 11: Program Details
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Parameter
Description
Update on
The date on which the latest changes were made and saved.
Start test/End test
Defines if these events are indicated by sound.
Parameter
Description
Modality
Four different types of sensation can be delivered to the subject: Warm sensation; Cold sensation; Hot pain.
Baseline (°C)
Temperature from which each new stimulation sequence begins – between 28°C to 40°C for Q-sense thermode.
Rate (°C/sec)
Defines the temperature rate of increase per second, from the baseline until the subject’s response. Type an acceptable value: 0.1 to 2°C/Sec for Q-sense thermode
Return Rate (°C/sec)
Defines the temperature rate of decrease per second, from the temperature at which the subject responded, down to the baseline. Type an acceptable value: .. 0.1-1°C/sec for Q-sense thermode.
Number of Trials
The number of trials in the sequence – between 1 to 100.
Randomize with next
Randomizes the next trial or sequence.
ISI Min (sec) / ISI Max (sec)
Variable time between trials. Type acceptable value: 2-100.
Standard Events
Enables the system to alert you when stimulation procedure arrives at some standard events.
Table 12: Program Parameters
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Test statistics are hidden by default. The bottom of the screen displays the total records (sequences) in the
current program.
Statistics Tab
Baseline Temperature
The following screen shows a test consisting of 2 sequences, each comprising of 4 trials:
Figure 31: A Limits Method Test
To view the statistics details, place the cursor at the bottom end of the statistics tab and drag it down.
Click the Tack icon at the upper right of the screen to lock or unlock the statistics display (indicated by the circle in XFigure 31).
Following are the statistic details:
Figure 32: Statistical analysis of results
The following information is displayed:
Sequence index.
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It is possible to remove a Limits Trail using the Delete button on the PC key board. Refer to section 6.4.3, page 56 for details.
When adding or editing programs, follow these rules:
Enter meaningful information in the Program Description section of the screen.
Define all the parameters of a sequence for that sequence to be valid.
If not all the sequences are displayed, use the horizontal scroll bar to display the ones that are out of sight.
Modality – WS (warm sensation); CS (cold sensation); HP (hot pain). Number of recorded trials. Averaged temperature – In each of the sequence trials, the subject stops the temperature
change once perceiving a predefined sensation. The temperatures at which the subject stopped the stimulations are averaged to yield the value of the threshold.
Variance and STD (Standard Deviation) – Statistical measures of the variation in the
distribution of the temperatures that are averaged to give the threshold. Variance and STD are calculated for a finite sample.
7.6.2 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 a method explanation, refer to section 2.7.2, page 29.
Figure 33: Program Menu – Levels
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Missing or incorrect parameters are identified by an icon that flashes next to the relevant field. A short description of the malfunction can be
displayed by holding the cursor over the relevant icon.
Parameter
Description
Program Name
Displays the name of the program (editable).
Probe
Displays the probe that is used in this program.
Description
Under Description, click the arrow ; then type free text to describe the program. The Description icon is indicated as active ( ).
Update on
The date on which the latest changes were made and saved.
Start test/End test
Defines if these events are indicated by Sound.
Parameter
Description
Modality
Two different types of sensation can be delivered to the subject: Warm sensation; Cold sensation.
Baseline (°C)
Temperature from which each new stimulation sequence begins – between 28°C to 40°C for Q-sense thermode.
Trigger
Defines the trigger type: Auto or Manual.
Time Before Sequence (sec)
The time interval before the first trial of the current sequence between 0 to 600 seconds.
Destination Rate (°C/sec)
Defines the temperature rate of increase or decrease per second, from the baseline until the current destination temperature.
Type an acceptable value: ...................................................
0.1 to 2°C/Sec for Q-sense thermode Increasing temperature or
0.1 to 1°C/Sec for Q-sense thermode Decreasing temperature
The program menu varies according to the probe and the method of stimuli in use, as shown at the left side of the screen.
The parameters available for program creation at this stage are as follows:
Table 13: Program Details
Table 14: Program Parameters
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Return Rate (°C/sec)
Defines the temperature rate of increase or decrease per second, from the destination temperature, down to the baseline.
Type an acceptable value: ...................................................
0.1 to 2°C/Sec for Q-sense thermode Increasing temperature or
0.1 to 1°C/Sec for Q-sense thermode Decreasing temperature
Max. Time at Destination (sec)
Defines the maximum duration in seconds, between the time that the temperature reached the destination and the time it returned to the baseline. In case a YES response was detected, the maximum time will not complete, and the temperature will return to the baseline and continue to the next trial. Acceptable value: 0 to 600, and according to safety temperature – time limitations.
Min. Interval (sec) / Max. Interval (sec)
Variable time between trials. Actual time is set randomly in between the min. and max. values.
First Choice Step (°C)
The initial step size that is used until the first YES response is detected. Acceptable value: 0.2 – 5 °C
Final Choice Step (°C)
The fixed step size that is used in the final Turns Around Threshold. Acceptable value: 0.1 – 2 °C
Turns Around Threshold
The number of turns (YES to NO or NO to YES) at the Final Choice Step which is required to complete the test.
Number of Tests
The number of tests in a sequence – between 1 to 5.
Standard Events
Enables the system to alert you when stimulation procedure arrives at specific standard events.
Dummy Option
Enables dummy stimulus to increase test reliability. Dummy frequency is randomized, and it has average of 10%.
Randomize
Randomizes number of tests in order to increase sequence reliability.
Display Message
Determine when message to test subject is displayed on screen. Available options: Destination – Display message upon reaching trail destination temperature Return to Baseline – Display message upon trail return to baseline temperature
No Response on Destination
Define program behavior if 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’).
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Test statistics are hidden by default.
The bottom of the screen displays the total records (sequences) in the current program.
Baseline Temperature
Statistics tab
The following screen shows a sequence of Levels Method Test:
Figure 34: A Levels Method Test
To view the statistics details, place the cursor at the bottom end of the statistics tab and drag it down.
Click the Tack icon at the upper right of the screen to lock or unlock the statistics display (indicated by the circle in XFigure 31).
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Following are the statistic details:
Figure 35: Statistical Analysis of the Results
The following information is displayed:
Sequence index. Used modality – WS (warm sensation); CS (cold sensation). Number of recorded stimuli and number of turns. Threshold – In test trial, the subject response is recorded. The threshold is calculated as
the average response of the last two trials.
Dummies – The total number of dummy stimuli and their response type (Yes or No).
7.6.3 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 a method explanation, refer to section 2.7.3, page 29.
Figure 36: Program Menu – TSL
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When adding or editing programs, follow these rules:
Enter meaningful information in the Program Description section of the screen.
Define all the parameters of a sequence for that sequence to be valid.
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 identified by an icon that flashes next to the relevant field. A short description of the malfunction can be displayed by holding the cursor over the
relevant icon.
Parameter
Description
Program Name
Displays the name of the program (editable).
Probe
Displays the probe that is used in this program.
Description
Under Description, click the arrow ; then type free text to describe the program. The Description icon is indicated as active ( ).
Update on
The date on which the latest changes were made and saved.
Start test/End test
Defines if these events are indicated by Sound.
Parameter
Description
Baseline Temperature (°C)
Temperature from which each new stimulation sequence begins – between 28°C to 40°C for Q-sense thermode.
Time Before Sequence (sec)
The time interval before the first trial of the current sequence. Ranges between 0 to 600 seconds.
First stimulus
Determines whether the TSL test will start with warm or cold stimulus.
The program menu varies according to the probe and the method of stimuli in use, as shown at the left side of the screen.
The parameters available for program creation at this stage are as follows:
Table 15: Program Details
Table 16: Program Parameters
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Increase Rate (°C/sec)
Defines the temperature rate of increase per second, from the destination temperature down to the baseline. Type an acceptable value: . 0.1- 2°C/sec for Q-sense thermode.
Decrease Rate (°C/sec)
Defines the temperature rate of decrease per second, from the baseline until a response is recognized. Type an acceptable value: .. 0.1-1°C/Sec for Q-sense thermode
Number of stimuli
The number of required subject responses until test termination.
Standard Events
Enables the system to alert you when stimulation procedure arrives at specific standard events.
Test statistics are hidden by default.
The bottom of the screen displays the total records (sequences) in the current program.
Statistics tab
Baseline Temperatur
The following screen shows a sequence consisting of TSL Method Test:
Figure 37: A TSL Method Test
To view the statistics details, place the cursor at the bottom end of the statistics tab and drag it down.
Click the Tack icon at the upper right of the screen to lock or unlock the statistics display (indicated by the circle in Figure 37).
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Following are the statistic details:
Figure 38: Statistical Analysis of the Results
The following information is displayed:
Sequence index. WS (warm sensation) – Threshold CS (cold sensation) – Threshold D – the absolute difference between WS and CS Number of recorded stimuli. Variance and STD (Standard Deviation) – Statistical measures of the variation in the
distribution of the temperatures that are averaged to give the threshold.
7.6.4 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 2.7.4, page
30.
Figure 39: Program Menu – Ramp and Hold
The table below describes the program parameters available for Ramp and Hold method:
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Parameter
Description
Baseline (°C)
Temperature from which each new stimulation sequence begins. – Between 28°C to 40°C for Q-sense thermode.
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
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.
0.1 to 1°C/Sec for Q-sense thermode.
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.
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.
0.1 to 1°C/Sec for Q-Sense thermode
Number of Trials
The number of trials per sequence. Valid range: 1 to 100
Enable Pain Rating
Enables pain rating patient response at the end of the duration time of each trial
Advanced options are available for configuration with specific license. See section 25.4 page 180
Randomize with next
Randomize trials with next sequence
ISI Min (sec)
Minimum Inter-Stimulus-Interval (ISI). Valid range: 0 to 600 (sec)
Table 17: Program Parameters
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Parameter
Description
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
Enables the system to alert you when stimulation procedure arrives at specific standard events.
Note that this program is available only with special license and not a part of basic Q-Sense configuration
Parameter
Description
Baseline (°C)
Temperature from which each new stimulation sequence begins. Valid range:
28°C to 40°C
Trigger
Trigger mode: Automatic – the stimulus will start automatically after the
defined Inter Stimulus Interval (ISI).
7.6.5 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 2.7.5 page 31.
Figure 40: Program Editor – VAS Search
The table below describes the program parameters available for the VAS Search method:
Table 18: Program Parameters
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Note that this program is available only with special license and not a part of basic Q-Sense configuration
Manual – The operator will initiate the onset of the stimulus
after the defined ISI.
First destination temperature (°C)
Defines the destination temperature for the first trial. 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. Valid range: 0.1 to 2°C/Sec
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 Rate
Defines the temperature change rate from the destination to baseline temperature. Valid range: 0.1 to 1°C/Sec
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)
Waiting time for response (sec)
Time for which the pain rating dialog will remain on the screen waiting for user to respond.
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 7.6.7
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Parameter
Description
Probe
The probe to be used in that specific sub-program.
Method
The method to be used in that specific sub-program.
Program name
A meaningful name for the specific sub-program.
Cycles
The number of cycles to be executed in that specific sub­test.
Column
Description
Program name
The program name (editable).
7.6.6 Chaining Programs
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.
For a method explanation, refer to section 2.7.6, Page 32. As can be viewed in Figure 41, a program list is present for the user to choose from, when
constructing the master program. Each sub-program is defined by the following factors:
Table 19: Chain sub program parameters
Figure 41: Program Chain Editor
The program menu varies according to the probe, and the method of stimuli intended for use, as shown on the left side of the screen.
The parameters available for program creation at this stage are as follows:
Table 20: Program Details
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Column
Description
Probe
The probes used with this program.
Description
Under Description, click the arrow ; then type free text to describe the program. The Description icon is indicated as active ( ).
Update on
The date on which the latest changes were made and saved.
Parameter
Description
Program list
A list of the available programs.
The serial number of the chained program. The serial number indicates the execution order of the programs.
Probe
The thermode type to be used in the chained program.
Method
Test method of the chained program.
Program name
Name of the chained program.
Cycles
Number of times the chained program is to be performed. To change the value, type the new one, or use the Up/Down arrows.
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).
Table 21: Program Table
The following additional functions are available:
7.6.7 Next Sequence Definition
In Limits, TSL and Ramp & Hold protocols additional settings are available in the top part of program editor, allowing different options for next sequence definition during the program run:
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Figure 42: 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
- 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 43: 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)
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Program Method
Standard Events
Description Limits
Onset
The start of each trial in the sequence
Levels
Onset
The start of each trial in the sequence
TSL
Destination
Subject response was detected
Ramp and Hold
(optional)
Onset
The start of each trial in the sequence
Note: In current release that is the only Standard Event available for Ramp and Hold.
Destination
Thermode temperature reached target temperature
Note: Will be available in next release
End of duration
End of duration at target temperature Note: Will be available in next release
7.7 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 are marked by a sound.
Every event is also marked on the screen during the test by an asterisk (*).
7.7.1 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 44: Standard Events in Program Editor
3. Click the arrow on the left to open the standard event editor.
For each event that you want to configure mark the Sound column to activate.
4. Click anywhere on the screen to close the Standard Events dialog.
5. 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.
7.7.2 List of Standard Events according to Program Type
The available standard events according to program type are detailed in the table below:
Table 22: List of standard events according to program type
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Note that importing and exporting program data between different software versions may result in compatibility errors and loss of data. Check database compatibility before proceeding.
7.8 Test Instructions
In some cases, the general program instructions do not fully apply to specific programs, and unique instructions are required.
To enter test instructions, perform to the following procedure. All other (standard) tests will be assigned the standard instructions, as entered in section 10.3.2, page 129.
11. From the program list at the left, select the required program, and double-click, or click the
Edit program details button . The Programs menu is displayed.
12. Click the Accesses test instructions button .
The following screen is displayed:
Figure 45: Test Instructions Editor
13. To edit the text instructions,
13.1. Deselect the relevant Use default instruction checkbox.
The Edit button becomes enabled.
13.2. Click the Edit button.
The text editor is displayed, displaying the standard instructions.
13.3. Edit the instructions as required, as described in section10.3.2.1, page129.
14. To replace the audio instructions,
14.1. Deselect the relevant Use default instruction checkbox.
The Play button becomes an enabled Browse button.
14.2. Click the Browse button.
The Audio instruction screen is displayed.
14.3. Replace the instructions file, as described in section 10.3.2.2, page 130 X
7.9 Import / Export Program
Program details can be imported to and exported from MEDOC Main Station using a secure and unique format which is readable from MEDOC software only. The file extension is ats.
In order to export Q-SENSE programs follow the procedure below:
1. Open the program list in the Programs screen.
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MEDOC Main Station identifies and allows you to manually solve any conflicts that may arise when importing programs. For example, programs with the same name.
2. Select the programs to export. Multiple selection is possible by holding down the Ctrl and
Shift buttons on the keyboard
3. Click File Export.
4. Select the location and name of the exported programs.
5. Click the Save button.
The selected programs are saved to the selected location under the selected name.
In order to import Q-SENSE programs follow the procedure below:
1. Click File Import.
2. Browse to the location of the exported programs and select the program you want to import.
3. Click on the Open button.
The imported programs are added to your program list.
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The more criteria you define using the filter, the shorter the list that will be displayed.
In order to add / remove fields from Patient table, see section10.1.2, page 106.
It is possible to change column order by drag and drop it to required place.
8 Patient Management
8.1 Patients List
The Patients screen enables you to manage patients (add, remove, edits etc.) and department information.
1. To access the patient database, click the Patients button at the toolbar. The following screen
is displayed:
Figure 46: Patients List
2. To narrow down the displayed list use the filter row.
3. To clear the filtered list, select the (All) option from the filter drop down list.
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New Patient
Delete Patient
Edit Patient details
or
Show or Hide Patient preview
The following options are available in the Patient Management screen:
Current Selection control - displays the selected program information.
When you open the Patient Preview bar, the following screen is displayed:
Figure 47: Patient Management – Patient details preview
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Patient details cannot be edited from the preview control screen
Missing or incorrect parameters are identified by an icon that flashes next to the relevant field. A short description of the malfunction can be displayed by holding the cursor over the
relevant icon.
8.2 Add New Patient
To add a patient to the patients list:
15. Click the Add icon ( ).
The Patient details screen is displayed:
Figure 48: Patients Editor Screen
16. Insert all the relevant patient data.
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Adding a department can only be done by an administrator. See section 8.5 page 86.
The information displayed on the screen (field names) can be customized according to the setup defined by each user. Refer to section 10.1.2, page 106.
Department management is enabled according to the authorization level of the current user. For further information, refer to section 10.1.5, Page 116.
17. Click the Save icon ( ).
18. After adding and saving all the required patients, click the Return icon ( ) to return to
the Patients list screen.
8.3 Remove Patient
To remove a patient from the patients list:
3. Click the Delete icon ( ).
4. Click Yes to the prompt.
The selected patient is deleted.
8.4 Edit Patient Details
To edit a patient from the patients list:
5. Click the Edit icon ( ).
6. The selected patient parameters screen is open and can be edited.
8.5 Department Management
MEDOC Main Station enables you to mange (Add, Edit, Remove) your patient department.
1. From the Utilities menu at the top of the screen, select the Department option.
The Edit departments menu is displayed:
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Figure 49: Edit Department Menu
2. To define 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.
(Available only for System Administrators and Medical Supervisors)
4. To remove a department, select the required department; then click the Remove button. At
the prompt click the OK button. (Available only for System Administrators and Medical Supervisors)
5. To close the dialog, click the Close button.
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ICD 9 management is enabled according to the authorization level of the current user. For further information, refer to section 10.1.5, Page 116.
Note that importing and exporting Patient data between different software versions may result in compatibility errors and loss of data. Check database compatibility before proceeding.
8.6 ICD 9 Management
MEDOC Main Station enables you to mange (Add, Edit, Remove) your ICD 9 code.
1. From the Utilities menu at the top of the screen, select the ICD 9 option.
The Edit departments menu is displayed:
Figure 50: Edit ICD Menu
2. To define a new ICD 9 code, click the New button; then, type the ICD 9 code and description,
and click OK.
3. To edit an ICD 9 code, select the required code; then click the Edit button.
(Available only for System Administrators and Medical Supervisors). A code and description window is opened. Edit the relevant fields and click OK.
4. To remove a code, select the required department; then click the Remove button. At the
prompt click the OK button. (Available only for System Administrators and Medical Supervisors)
To close the dialog, click the Close button.
8.7 Import / Export Patient Lists
Patient details can be imported to and exported from MEDOC Main Station using a secure and unique format which is readable from MEDOC software only. The file extension is ats.
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MEDOC Main Station software identifies and allows you to manually solve any conflicts that may arise when importing patients. For example, patients with the same unique field.
In order to export Q-SENSE patients follow procedure below:
1. Open the patient list in the Patient screen.
2. Select the patients to export. Multiple selection is possible by holding down the Ctrl and Shift
buttons on the keyboard
3. Click File Export.
4. Select the location and name of the exported patients.
5. Click the Save button.
The selected patients are saved to the selected location under the selected name.
In order to import Q-SENSE patients follow the procedure below:
1. Click File Import.
2. Browse to the location of the exported patients and select the patients you want to import.
3. Click on the Open button.
The imported patients are added to your patients list.
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The more criteria you define using the filter, the shorter the list that will be displayed.
In order to add / remove fields from Results table, see section
10.1.3, page 110.
It is possible to change column order by drag and drop it to required place.
9 Results Management
The Results List screen lists the results of the recent test.
9.1 Results List
The Results screen enables you to manage Results (view, print, delete, etc.).
1. To access the results database, click the Results button at the toolbar. The following screen is
displayed:
Figure 51: Results List
2. To narrow down the displayed list use the filter row.
3. To clear the filtered list, select the (All) option from the filter drop down list.
The following options are available in the results management screen:
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or
Show or Hide Results preview
Print Selected Results file / files
Delete selected Results file from Q­SENSE Data Base
View Patient details
Display Results graph preview. Available on selected methods.
Display test subject details preview.
Display the Result Body Site. Available only if a Body Site was selected.
Current Selection control - displays the selected program information. When you open the Results preview bar, the following screen is displayed:
Figure 52: Result preview display
The following options are available:
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Delete selected results file.
Print Graph
Check box
Show / Hide Normative Data display.
Note that importing and exporting test results between different software versions may result in compatibility errors and loss of data. Check database compatibility before proceeding.
9.2 Import / Export Results
Test Results can be imported to and exported from MEDOC Main Station using a secure and unique format which is readable from MEDOC software only. The file extension is ats. Alternatively, results can be exported as an excel file (.xls) for further analysis.
In order to export Q-SENSE Results to .ats format follow the procedure below:
1. Open the results list in the Results screen.
2. Select the results to export. Multiple selection is possible by holding down the Ctrl and Shift
buttons on the keyboard
3. Click File Export.
4. Select the location and name of the exported results.
5. Click the Save button.
The selected results are saved to the selected location under the selected name.
In order to export Q-SENSE Results to .xls format follow the procedure below:
1. Open the results list in the Results screen.
2. Select the results to export.
3. Click File Export to Excel.
4. Select the location for the exported results.
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 all sub-programs of the chain program.
The resulting Excel file is divided into two tabs:
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Description: containing general patient and test data:
Figure 53: Export Result File Opened In Excel – Description Tab Sample
Data: containing the detailed information of the test:
Figure 54: Export Result File Opened In Excel – Data Tab Sample
In order to import Q-SENSE results, follow the procedure below:
1. Click File Import.
2. Browse to the location of the exported results and select the results you want to import (only
for .ats format)
3. Click on the Open button.
The imported results are added to your results list.
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MEDOC Main Station identifies and allows you to manually solve any conflicts that may rise when importing results. For example, results with same patient name date and time.
Saved Results cannot be edited or modified.
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9.3 Print Results and Reports
MEDOC Main Station has a powerful Analysis and Results Report Generator that can be customized for user needs.
Follow these steps to print your results:
1. Select the relevant results file or files from the list in the results screen.
2. Click on the Print button
The following screen is displayed:
Figure 55: Analysis Reports Dialog
3. Configure the Reports options according to your needs.
4. Press on the button of the Report Type you want to use from available options.
Only available reports type are enabled according to your results file selection.
5. Report is generated. Report may have Preview or not according to your preferences.
5.1. Print with Preview
Print Preview is displayed according to the active template and test method. Refer to 10.1.3, page 110 for details regarding Printing Options. Press the Print icon or select one of the export options.
5.2. Print without Preview
Report is sent to a connected printer. Select your Printing preferences according to the available printers and print your report.
9.3.1 Analysis Report Dialog
The Analysis Report Dialog allows Q-SENSE user to generate Reports of Q-SENSE tests.
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Report template can be edited and customized according to specific needs. Refer to section 10.1.3, page 110 for details
Report Type
Description
Restrictions
Singles
Print a single report for each selected Test Results according to active template.
None
Multiple
Print results statistic summary of selected tests.
1. Test Method: TSL, Levels, Limits
Bilateral
Compare test statistics of same body site of two sides (Left and Right) for same body site and test subject.
1. Test Method: TSL, Levels, Limits
2. Selection of 2 result files
3. Identical Test Subject
4. Identical Test Program
5. Identical Main and Specific body site
6. Opposite body site sides
Figure 56: Analysis Report
9.3.1.1 Analysis Report Type
Report type defines the template and content of the report and analysis to be displayed.
The following templates are available:
Table 23: Report Analysis Configuration
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Report Type
Description
Restrictions
Site to Site
Compare test statistics of same test subject in two different Body Sites.
1. Test Method: TSL, Levels, Limits
2. Selection of 2 result files
3. Identical Test Subject
4. Identical Test Program
5. Different Main and / or Specific Site
Pre / Post
Compare test statistics of same test subject and site, performed in different date and time
1. Test Method: TSL, Levels, Limits
2. Selection of 2 result files
3. Identical Test Subject
4. Identical Test Program
5. Identical Body Site
Trend
Display test statistic trend vs. test date and time.
1. Test Method: TSL, Levels, Limits
2. Selection of 2 result files or more
3. Identical Test Subject
4. Identical Test Program
5. Identical Body Site
Custom
Custom report with custom analysis and restrictions.
Vary according to report analysis Contact Medoc Service for Details.
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Figure 57: Single Results Report
Figure 58: Multiple Results Report
Reports Examples:
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Analysis Report Examples:
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Figure 59: Site to Site Results Report
Figure 60: Pre / Post Results Report
Figure 61: Trend Results Report
Figure 62: Custom Report Results
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