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1. After the test there are opt Calibration Messages Difficulty Extreme I eal indicator of the client stress condition 1 Dialogue with client to 2 Consider general stress Stress in nerves Part 22 Saving Patient Data It is prudent to have back ups of any important information as a matter of course and as security before updating the software irrent high stress dback gt Biofeedback gt Reduce To back up your clients first you need to install the Backup Restore program 2010 Paradox and SQLite software Please follow the procedure as outlined below e Ifyou have the Clasp32 installer on a DVD put it in to the DVD drive the auto runner will start the installation e If you downloaded the Clasp32 installer please open My Computer and go to C drive Page 37 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary e On the CT drive you will find the Clasp32 Install DVD folder open it and run the Start exe e The installation begins with a Clasp32 Install window with 4 buttons on it Backup Data Clasp32 Video Codec Restore Data e Please click on the Backup Data button e The Backup Restore program 2010 Paradox and SQLite Installation wizard comes up with a Welcome screen where you need to click the Next button e On the next window you can select w
2. Tutorials available on www gxsubspace com for easy ion and Activation 16 July men and Do 2009 nder Part installation i my Internet Adding in Section 13 2 Installation point 2 If you have the software on DVD place the MASTER DVD 1 in the appropriate drive 5 Adding in Section 13 2 Installation point 2 If you have downloaded the software it will install on the drive that you selected 6 Adding in Section 13 2 Installation point 3 Install program 7 Updating Section 15 USB to USB Cable Installation Instructions to installation from DVD and installation from internet downloadable version 8 Adding point 2 to Section 17 Important Procedure to Andrea Taflan Page 61 of 63 www qxsubspace com SCIO User Manual 200003 K www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Complete Activation Type your device serial number in the box at the bottom of the screen and click Load m Number Inclusion of Section 6 4 X ray Exposure F 9 June 2009 Inclusion of section 5 4 Undesirable Side Effects Inclusion of Caution Use this device with a computer on battery mode free from wall current or with a medically safe surge protector Reference to use battery mode or with medically safe surge protector in section 6 1 Inclusion
3. at the top right This may reveal an information panel below Close this This appears to happen mainly with Windows XP 2 If you have minimized a panel it will show as Consciousness on the bottom toolbar Click to restore the view and close the minimized panel 3 There may be a SCIO operation in progress this will disable Windows A red Windows Interrupted and or SCIO is Working panel will generally show Wait until this disappears At times this stays if you are sure that the operation has finished then double click in the top right corner to remove the panel or use the close button on the interrupt 4 You have played with the mouse when there is a SCIO operation Windows Interrupt This can confuse the system leading to a lock up Ctrl Alt Del is your only option this will display Task manager Select Consciousness in the Applications tab and End Program During reloading you will be asked if you want to restore the last client saying yes will restore all the client information Enter password Page 33 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary details as normal ensure that the correct client displays in Demographics and proceed from where you left off 5 fthis fails use the task manager to close down the computer 6 The final port of call is to use the power button to close d
4. APPENDIX C WARRA B H EBRRRRREEMER 52 APPENDIX D SOFTWARE LICENSE AGREEMENTE cere ee eese eo noe ee eode seen en eee eese ee tn aset een esee ena 54 APPENDIX E REVISIONIHIISEGIR EE EE erre ener ener nee erto oou 56 Page 4 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Welcome Letter Dear Friends of the SCIO We would like to take this opportunity to welcome you to the newest wave in Universal Electrophysiological Biofeedback Systems We hope that you are enthusiastic about joining the worldwide family of SCIO Users It is required to read through these pages before first connecting turning on or using your SCIO and to always keep this User Manual as a reference for future uses of your SCIO This will assist you in using your SCIO Please read this User Manual thoroughly Should you have any questions please contact the representative from whom you purchased the device At the end of the manual you canefifid the Revision History which tells you what has been changed since the previous vefsion Please reference this to help you understand what has been changed Please note the following 1 Effective 20 February 2009 the Clasp32 Software will NOT be included in your shipment from the Manufacturer Mandelay Kft in Budapest Hungary Instead you sh
5. and check that the COM port settings are correct as explained in Part 16 above If there is a LED issue then the device may be sent to an authorized Service Center listed under Policies amp Procedure in the Service Center Policy 34 In Appendix C Warranty Contract under section 1 the following has been added Based on industry standards of the materials used and the fact that the device does not have movable parts the life of the device has been established to be up to 10 years and Page 60 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary perhaps longer than 10 years There is no expiration date on the life of the device as some are known to be using their device since 1997 with no problems The harnesses are considered to be movable parts and therefore have a recommended lifetime of up to 3 years from the first use and are easily replaced The device has a shelf life of up to ten 10 years from the date of manufacture and should be refurbished within that time frame 35 Under Appendix C Warranty Contract Section 8 the following changes have been made an Authorized Service Center through the User s online account with www qxsubspace com to order the service 36 Under Part 13 the following sentence has been added Furthermore there are numerous Video
6. BUDAPEST HOME OFFICE BHO Budapest Hungary Part 19 Practicalities The following practicalities will be helpful in using the device and also in some troubleshooting solutions Part 19 1 Accessing the Functions There are several methods of initiating and terminating operations within the device e Buttons clicking on these will initiate an action e Edit box information can be added into these by typing or in some screens by double clicking on an item Edit boxes can have information altered in them in the same way as any text or word processing i e using backspace delete keys etc e In many cases button functions are duplicated in drop down lists from the top program toolbar Movihig the mouse to the drop down list will generally open it up Clicking on an itemfn the list will initiate the described action i e therapy or routing to another screen e Insome screens single or double clicking on an item will initiate a therapy e In many cases the label for an item e g test may contain an underscore e g T In these cases typing the letter T or Alt T is an option to initiating the action e To further assist when a mouse is moved near a button or a picture on the screen a small hint will often appear for 3 seconds Part 19 2 Frozen Screens During periods of extended use or with a reduced specification system lock up or screen freezing may occur It may seem unable to exit a screen 1 Try minimizing the screen using the
7. K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Resonance The client reactivity to an item after 1 second exposure Indicative of ongoing significance of an item Sarcode Resonance Indicates how much resonance there is to a healthy energetic pattern High values indicate over functioning too much energy probably healthy but stressed from outside source Below 50 indicates under functioning too little energy with a possibility of unhealthy or disturbed tissue Selye Stress Scale A stress scale rating that indicates where the client body electric is in terms of alarm adaptation and exhaustion SOC Suppression and obstruction to cure as calculated in the demographics panel Test Matrix Item S of stressors prepared as a ement of their energetic Therapist e interchangeable ates the device or personal use themselves a ir family on a Trivector sional electrical characterize the onductance static ductance voltage User apist can be interchangeable as they refer to the person who operates the device Someone using the device for themselves for personal use on themselves or their family would call themselves a User If they see someone outside of their family on a regular basis they would call themselves is a Therapist Yellow Color Band Items that the client has a reactivity of more than one stan
8. LED s These are indicative of harness activities Part 21 Quick Start This is the basic guide to get your started It is suggested to follow these steps with every Client Remember that your training as a certified biofeedback technician your dialogue with the Client the Client s reason s for the session s and the Client s progress should determine your course of action during the session The following steps are just to get started Part 21 1 Program O Step Action tions 1 CLASP 32 Ic s stops at 25 to l E if found di ction check a continue 2 Continue small button 3 Password gt 4 Demographic 4 1 New Client Enter Name Sex SOC table Patient Data Load New or Previous Patient New Patient gt OK gt Enter DoB gt Save Current Patient gt Close 4 2 Old Patient second visit Patient Data Load New or Previous Patient Select Client in List gt Previous Patient Page 36 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary 5 Demographics Has client SOC Changed o NO gt Close o YES Change values Patient Data Load New or Previous Patient Modify Save Close Part 21 2 Calibration Step Action 1 Main Screen Calibration 2 FAST Track Calibration
9. and Murray 1968 who argued that such results may be due to skeletal mediators and have still obtained positive results For example Lang and Melamed 1969 were able t condition aversively 49 month old child who suffered from ruminative vomitingn addition Frezza and Holland 1971 demonstrated that human salivation can be iNstrumentally conditioned Subsequently biofeedback procedures were applied to clinical problems In 1973 two innovative therapy procedures were developed which are widely used today with certain technical refinements Elmer and Alyce Green 1977 developed a clinical protocol for thermal feedback training They used peripheral skin temperature as a measure of vasodilatation and combined skin temperature feedback with Schultz and Luthe s 1969 Autogenic Training Sargent Green and Walters 1972 applied temperature biofeedback training to treat migraine Clients were taught to increase the warmth in their fingers vasodilatation while decreasing the temperature of their foreheads vasoconstriction They found that almost 75 percent of the subjectsywere able to decrease both the duration and intensity of migraine attacks Later studies have confirmed these results While the Green s were developing their therapy technique for migraine Thomas Budzynski 1973 and his associates at the University of Colorado developed a feedback technique to treat muscle contraction tension headaches They used EMG training to teach cl
10. can autofocus TVEP transcutaneous voltammetric evoked potential stimulation The SCIO was designed to do biofeedback transcutaneous interaction to the client s CNS In summary individuals in certain circumstances can learn to control various physiologic processes as a result of biofeedback training Neuroanatomical and Physiological Basis of Biofeedback Neurophysiologists and clinical neurologists are aware of the fact that the brain acts as a CNS whole unit and that the functioning of each and every part of it affects the performance of most of the other parts Clearly however certain areas are more closely allied than others by anatomical or physiological links Also there is a localization of function such that the different regions of the brain are specialized for certain activities and although their role can be substituted to a certain extent they operate most effectively only when carrying out their particular function Broadly speaking the tasks of the brain can be divided into three great categories 1 The reception of stimuli this is the sensory system 2 Theassociation of stimuli and the analysis of perception of incoming stimuli Page 16 of 63 SCIO User Manual 200003 K www qxsubspace com Www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary 3 The motor response to those stimuli or the autonomic response to internal and external stim
11. click on the User Accounts Classical view or open the User Accounts and Family Safety and the User Account Vista view There you will find a link called Turn User Account Control on or off open it In the next screen you will find a checkbox called User Account Control UAC to help protect your Computer uncheck it NOTE The UAC must be turned off for the stabil running and the installation of the Clasp 32 software b Reboot your computer and wait until the boot sequence is finished If you have the software on DVD place the DVD in the appropriate drive Wait a minute quite literally The DVD should auto load Should that not occur because either the setting auto run ofthe drive is not activated or the drive does not properly register the DVD double click on the desktop icon My Computer right click on the DVD drive choose Explore and double click on the torch icon Start If you have downloaded the software it will install on the drive that you selected Click on Clasp32 and then follow the Installation Wizard s instructions On the second screen of the Installation Wizard the software automatically selects all of the additional programs to be installed Clasp32 Database BodyViewer Disease Lexicon and Ant Smoking Click Next 5 On the following screen you can select where to install the software we STRONGLY recommend the default folder Click Next Page 24 of 63 SCIO User Manual 200003 K www
12. com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary errors Throughout the years we have found that most problems come from a faulty computer a faulty installation of the Operating System and in most cases from inappropriate computer maintenance If you have any problems please contact your Representative We urge you to try to get the best possible training regarding the use and applications of our system The better you know our system the more benefit your clients are going to have Please see our website www qxsubspace com as well as our conference website www qxconference com for more information Our system is the most sophisticated tool in the market but it can only perform as good as the therapist who handles it Welcome to the cutting edge in Universal Electrophysiological Biofeedback Yours faithfully The Mandelay Kft s Team Page 6 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Part 1 What is the SCIO The SCIO Scientific Consciousness Interface Operations System is a universal electrophysiological biofeedback system It coordinates a complex electro modal biofeedback program with computer software in order to gather bioenergetic information of a client s subconscious The information is gathered from
13. contact the Quality Manager of the Manufacturer Mandelay Kft directly Do not use on patients with epilepsy or a history of epilepsy Do not use this device with a pacemaker Do not use on patients with electrical hyper reactivity Do not use over irritated inflamed red or broken skin Do not use on pregnant women Do not use on children under 3 years of age Do not use on patients who are under the influence of drugs or alcohol SOV UTA E Part 5 3 Cautions In following with the Essential Requirements of a medical device Cautions must be clearly worded and stated to ensure the safe us of the device Therefore the following Cautions have been established based on ur Risk Analysis and mustybe implemented in your use of the device If you have any questions please contact the Quality Manager of the Manufacturer MandelayKft directly 1 Do not allow the metal part of the limb harnesses to directly touch the skin 2 Use caution with psychotic clients or clients with histories of electro shock 3 Usethis device with a computer on battery mode free from wall current or with a medically safe surge protector 4 Clean the harness after every use especially when there is a suspicion of infection Part 5 4 Undesirable Side Effects Mandelay Kft has performed a Risk Analysis to mitigate any possible undesirable side effects that may arise from the use of the SCIO However post market surveillance shows that
14. healthcare practitioner Part 5 5 Harness rules and connections The use of harnesses and or accessories that are not part of the original registered device are at the user s own risk Please see Appendix A Accessories Policy for a photograph of the original registered device including harnesses The connections are as follows Black lead to left an Blue lead to rig OOo00 Head harness to for strips in contact with right erapies with the the cable is left or It is best if the co reccomended spray or lotion is Part 5 6 Harness C Please check each time in the i arnings and cautions 1 Explain to the client the straps the and how long they will be present 2 Check if the client has had a previous experience which makes them fearful or uncomfortable with straps e g electroshock therapy Part 5 7 Cleaning the Harness Wipe clean the harness with a sterilising solution 3 to 596 peroxide dilute 1096 alcohol solution or equivalent between each use Avoid the use of strong cleaners that may damage the rubberized material Periodically clean the harness with warm soapy water Page 11 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Part 6 Electrical Safety The device has been proven to be safe and effective to all internationally recognized har
15. of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Part 12 Computer Preparations for the Clasp32 SCIO It is recommended to follow these procedures before the Clasp32 has been installed 1 Clearing your Startup Menu Go to Start Programs Startup and delete any program loaded there This is done clicking over the name of the program with the right button of the mouse to display the sub menu Choose Delete 2 On the Desktop it is advisable to only keep Shortcuts these are the icons with a little arrow in the bottom left corner Any other document should always be kept in My Documents The desktop should only contain the shortcuts to the most often used programs In fact I rec i imend to Ofilyshaving the Recycling Bin in the Desktop and the Shoxt uts in the Taskbar The bar at the bottom of the screen To do that it is necessary to drag the ieon from the Desktop and drop in the Taskbar For the Taskbar to allow icons it must be unlocked click with the right button of the mouse and in the contextual menu have the check mark next to Unlock l 3 Setting up your Display For Windows Vista or Windows 7 go to the Desktop right click click on Personalize for Windows 7 the next option is Screen Resolution click on Display Settin
16. qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary On the following screen Click Next to confirm and proceed with the installation Click Finish when the installation is complete Click on Close until you get back to the Windows desktop Remove DVD from drive 0 Restart the computer PO OND Page 25 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Part 14 Necessary Programs for the Clasp32 This page details programs you need to have on your operating system This can be done either before or after installing the Clasp32 1 Necessary a DivX Player and DivX Codec Please visit the website www divx com and download DivX 7 Please see the page Installation and Activation Procedure These are necessary to visualize some of the videos in the Clasp32 and in particular those included in the Biofeedback section Microsoft Word This program is necessary to visualize the great amount of written information available in the Clasp32 There are some documents that will guide you tlfrough the Clasp32 Internet Explofer 4 or later Web browser This program is necessary to go through theOnline Activation process Adobe Reader 7 0 or later Free version can be down
17. the Glossary Client Patient Therapist and User For the full definition please see the Glossary terms 26 In part 6 4 correction that it is 50 fifty exposures Page 59 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary to X ray One sentence was written with 50 and the other with 5 but the correct amount is 50 Additionally the following clause was added to the end under the Service Center Policy which can be found on www qxsubspace com 27 Part 24 Repair or Refurbishment to Your Device has been added to include the following For various reasons your device may need to be sent in for repair This is due to the normal wear and tear of internal parts If you find that your device is not functioning as it normally way then you can send it in for repair or refurbishment to an Authorized Service Center For more information on Service Centers please see the Service Center policy under Policies amp Procedures on the website www qxsubspace com 28 The Glossary is now Part 25 changed from Part nual which is 33 In Part 20 the following was revised If the lights are not functioning there may be a problem with the computer settings and not with the device Check that the UAC is turned off as explained in Part 13 2 above
18. 03 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary resources The specifications focus on the RAM but Cache must be taken into consideration Part 11 2 Computer Specifications It is advisable to dedicate a laptop to the program However if this is not possible then it is highly recommended that no other programs of medical nature be installed as conflicts have been reported in the past It is advisable to only install the recommended software and to follow the Computer preparation instructions If possible avoid the cloned types as many problems have been reported due to their architecture their timer chips and in some cases the cheap components It is recommended to have an Intel Core CPU Core 2 duo with a speed over 2 GHz Try to avoid Celeron because of the less cache factor The program itself requires about 5 GB of hard drive space for installation Always maintain at least 10 GB free in the hard drive so that regular maintenance can be carried out 2 GB of RAM is recomm The SCIO has a install the USB using a USB cable To SB Cable Installation Instructions Monitor TFT igher for optimum viewing of th Video and Sou ory available NOTE Due to chang above may change KEE TFT XGA Thin Film Technology Extended Graphics Array which allows displaying up to 65000 colors Page 21
19. 9 PRACTICALITIES 33 PART 19 1 ACCESSING THE FUNCTIONS seneese ineen E E NEEE E EEEE 33 PART 19 2 FROZEN SCREENS rinrin E E ee pea be E E RS 33 PART 19 3 RESTORING e EN 34 PART 19 4 BIOFEEDBACK AND DEMONSTRATION NERSIONS eese enne eenh nnns sisse neta nsns seen eere nnn 34 PART 20 CHECKING THE SCIO INTERFACE ee ee eene eee eene seen rose ee tn nest seen Pee eso eese eo asse seen sees eese sees eaa 35 PART 21 QUICK START e eeeecessvoes ee ENEE EES 36 PART 21 1 PROGRAM OPENING CLIENT DATA ENTREE 36 PART 21 2 CALIBRATION s etse dade EE E nE sedes estesa EE sess etna tensa ases ense sana 37 PART22 SAVING PATIENT DATA eo ooco co cune eos ooo ta rese eet o a aep Fo e saa rPPEC eo eben aee EEP SER EE Po Re Eee aaa Re e pP aS EVE ERR epe YR na epa 37 PART 23 RESTORING CLIENT DATA eee ein oae e io rore e he Fa neto Ro Pe set b eno ota da osa code Une se eene eee soe e nea S en aao E Ead 38 PART 24 REPAIRING OR REFURBISHING YOUR DEVICE eee eee seen ee eee tnos o eee to aset ttes esten a 39 PART 25 GLOSSARY e eeeeeee ooo oc osa E Ra eee eee eee eene eeen ee eee eene ee te ae eee eo aee epe 39 APPENDIX A ACCESSORIES POLICY eene enean neta enano onem atl in en sone ta susto tatu atas tatu stas tasa sens ta sas tn statuo 43 APPENDIX B GOOD MANUFACTURING PRACTICE GMP INFORMATION eene eren nuu 49
20. BUDAPEST HOME OFFICE BHO Budapest Hungary SCIO User Manual This user ed by the proper use Page 1 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Special thanks go to Dr John Kelsey PhD ND who helped create the first version of this manual on which this current version is based Written by Mandelay Kft Research amp Development TI Sziget Ipari Park 11 p H 2310 Szigetszentmikl s Hungary Website of the Manufacturer is SCIO User Manual g the title SCIO User Important Note It she 200003 is always the Manual 200003 lette est as possible by statements in the e statement always The translated vers qualified translato English language ve refer to the English la Page 2 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Table of Contents WELCOME LETTER E 5 PART 1 WHAT IS THE SCIO visccssssisscescsssessssossessssvseccossossssoscecsssesscesscotucissceviesescesssseesscasscecssosisscescesvecessessessdsosaeses 7 PART 2 23S COBB E 7 PART 3 INDICATIONS FOR USE oa oos eo sao vo Poet aeta cosoaseesisssoansesetsiessovssseseseasse
21. Reduction and Lifestyle Stressors Questionnaire 2 Simple EEG electroencephalography measuring volts biofeedback brain wave stress reduction 3 Three pole ECG electrocardiography Measuring amps simple heart awareness and biofeedback stres reduction 4 EMG electromy graphy measuring volts and UNI biofeedback for simple reeducation of muscles 5 GSR galvanic skin response measuring resistance biofeedback and TVEP transcutaneous voltammetric evoked potential biofeedback electrophysiological reactivity Since GSR biofeedback requires a microcurrent voltammetric stimulation to measure GSR then the microcurrent has the following secondary functions as performed through the biofeedback loop 6 Microcurrent Transcutaneous electro nerval stimulation MENS for pain reduction in the cybernetic biofeedback loop 7 Trauma or wound healing and electro o mosis in the biofeedback loop 8 Global Voltammetric Charge Stability Hydration Oxidation Proton balance in the biofeedback loop All of these functions combine to form a Universal Electrophysiological Biofeedback System for the following treatments a the detection of stress and reduction of stress b the treatment of injury muscle weakness dystonia muscle tension and or muscle spasm through muscular re education c the reduction of pain MENS microcurrent transcutaneous electro nerval stimulation d the healing of trauma and or wounds e measurement and rectification
22. ace com SCIO User Manual 200003 K www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary J 26 July 2010 11 Deleted FE See Flower Essences from Part 25 Glossary 12 Capitalized Essentially under Part 25 Glossary Imponderables 13 Updated Appendix A to reference the new electrodes added word the bananas and new pictures about the new harness 14 Updated Appendix B to change the following a Density of Output to Resolution of output voltage up to 1 5 of the final amplitude b Accuracy of output to Resolution of output voltage up to 1 5 of the final amplitude c Output resistance to min 1 KQ max 5kQ d Density o ion of Frequency e measured 4 Une ations for Use the following revisions were made c the reduction of pain reduction was added and e the rectification of charge stability rectification was added 5 Throughout the manual the database used for the software programming has been changed from Borland Database to SQLite Database 6 Part 12 section 3 has been revised to explain more how to change the resolution of your computer monitor 7 Part 13 2 Installation has been majorly revised to explain the current installation process of downloading and activating from the website www qxsubspace com Richard Lloyd Page 57
23. ar Re education Support 20 minutes 5 Miscellaneous multi media bi 5 10 minutes 6 Discuss and debri and support 5 10 minutes Agree on targets for t E 50 minutes Page 31 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Part 18 5 Timeframes These timeframes are suggested and you should decide on an individual basis what is best for you and your Client You can do Software Practice with a fictitious client as long as you wish within your comfortable timeframe of learning and practicing With Clients for basic stress detection and stress reduction we suggest weekly meetings of 50 minutes per session During these sessions you can focus on basic therapies such as those listed above under Basic Principles for Clients With Clients for acute stress you can meet 2 3 times per week but still keep the sessions at a maximum of 50 minutes per session puncturists who see Clients imum of 50 minutes per With Clients for chronic stre weekly for 6 weeks and t session With all patients g programs stress re yoga weight loss s avoid say no to drug assistance exercise es guided imagery hat to use what to he body naturally Page 32 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA
24. ave licenses for each computer to which the Software is distributed You must ensure that the number of persons using the Software installe e vork server does not exceed the number of licenses that you have If the number of users of I I server Willexceed the number of licenses you must purchase additional licenses until the ntimber of licenses equal the number of users before allowing additional users to use the Software If you area commefcial customer of Mandelay Kft you hereby granfMandelay Kft or an agent selected by Mandelay Kft the right to perform an audit use of the Software during normal business hours you agree to cooperate with Mandelay Kft In such audit you agree to provide Mandelay Kft with all records reasonably related to your use of the Software The audit will be limited to v gsm of your compliance with the terms of this agreement The Software is protected by copyright laws and WEE Ee treaties You may make one copy of the Software solely for backup or archival purposes or transfer it to a single hard disk providedyyou keep the original solely for backup or archival purposes You may not rent or lease the Software or copy the written materials accompanying the Software but you may transfer the Software and all accompanying materials on a permanent basis if you retain no copies and the recipient agrees to the terms hereof Any transfer mustinclude the most recent update and all previous versions You may not reverse engineer d
25. avigation e Focus on Naviga e Don t spend hou e You can learn th inating as it will be Part 18 3 Core We suggest that you t feel comfortable with the SCIO Once you e SCIO Opening the progra Password Screen Demographics lifestyle Calibration Testing getting a focus Themes First layer general stress balancing Second layer stress balancing Third layer stress balancing specific areas of focus Part 18 4 Basic Principles for Clients When meeting with Clients here are some suggested principles to keep in mind 1 Always do Demographics Energetic type therapies will work much better with lifestyle support Play with the numbers and recalculate the SOC to show the Client Page 30 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary the changes needed to get the SOC down to between 100 and 50 Guide your Client to set goals 2 You can do Fast Track Calibration 3 More is not better keep the sessions with your Clients to approximately 50 minutes But be flexible and use your own intuition and client interaction to finally decide what is best for your client 4 Here is a suggested session guideline Step Function Timing 1 Demographics and briefing session on what to expect 7 minutes 2 Calibration 2 minutes 3 Test and assay 6 minutes 4 Stress Reduction muscul
26. ay need to be sent in for repair If you find that your device is not functioning as it normally way then you can send it in for repair or refurbishment to an Authorized Service Genter For more information on Service Centers please see the Service Center policy under DowNLoAps Policies amp Procedures on the website www qxsubspace com Part 25 Glossary Allersode Energetic pattern of food inhalant etc at the sensitizing potency of 30C Body Capacitance The ratio of charge to potential being an indicator of the body s energy storing characteristics Calibration The initial process of establishing interface with the client where the clients optimum reactivity response time of exposure is established to a variety of items approximately 20 Client The terms Patient and Client can be interchangeable as they refer to the person who is connected to the device If the Therapist has a license then the therapist can refer to the person connected to the device as a Patient If the therapist does not have a license then the therapist can refer to the person connected to the device as a Client Page 39 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Coherence EPR Floating Fourier Number Hyperreactivity Hyporeactivity Impedance Imponderable Interface Value Cali
27. be bound by its terms and that this is the complete and exclusive statement of the agreement between you and Mandelay Kft regarding the Software Page 55 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Appendix E Revision History The following is a list of the major changes in the User Manual 200003 This table is updated with the most recent change at the top Revision Effectivity Date Description of Change Originator 21 February 2011 1 To change the name ofthe manufacturer from Maitrya Kft to Mandelay Kft 2 To change the address of the manufacturer to the current address of Mandelay Kft art 3 Indications for easuring and electro n Proton ba pecifications to 6 Updated Part 14 section 1 a to change this to these small changes to the Adobe Reader added e Notepad With this program users can write small notes and open small documents and deleted Adobe Acrobat 7 Part 16 Configuring the Port is updated 8 Updated Part 22 Saving Patient Data to reflect the new process of saving client files 9 Updated Part 23 Restoring Client Data to reflect the new process of restoring client files 10 At Part 24 Added DOWNLOADS word before Policies and Procedures Edit Barota Page 56 of 63 www qxsubsp
28. bration Isode Major Resonant Frequency Muscle Disturbance Muscle Tension Nosode Patient Page 40 of 63 www qxsubspace com Tel 36 21 252 3503 HU 1 989 681 1063 USA Budapest Hungary A measurement of the percentage of how close the return signal is to the original input signal Generally increases if there is a harmonic reaction of the client with numbers above 75 indicating a positive reaction Electro Physiological Reactivity Each time a screen is entered a retest of the item occurs The basis is that some interactions are quantic and do not repeat A dimensionless number that characterizes heat conduction Clients body energetic is reacting too quickly or an hyper immune mediated response Energetic pa The predominant frequency of the clients energetic body A high number indicates a disturbance but not necessarily intrinsic in the tissue Especially if the sarcode resonance is sound then there is likely to be a secondary external source The higher number indicating a higher tension or tightness Energetic pattern of issue tissue or pathogens The terms Patient and Client can be interchangeable as they refer to the person who is connected to the device If SCIO User Manual 200003 K www qxconference com 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary the Therapist has a license then the therapist can refer to the person connected to the device as a Patient If t
29. ce limited recognition between device and software lights will be dimmer than Before which would suggest that it might be time for refurbishment For options of refurbishment please contact an Authorized Service Center under the Service Center Policy which can be found on www qgxsubspace com Part 7 Copyright The right of Mandelay Kft as the author of this manual has been asserted by the company in accordance with Copyright Designs and Patents Act 1988 and all associated international protection All rights are reserved independent of the sourcing route No parts may be reproduced stored in a retrieval system or transmitted in any form by any means without the prior written permission of the author Part 8 Accuracy Every effort has been made to ensure the accuracy of the information provided No information is intended to be used or should be used as a substitute for information from a licensed healthcare practitioner Part 9 A Brief History of Biofeedback Edmund Jacobson in 1908 developed the progressive muscle relaxation technique 1958 Although most of his research on the conditioning of muscle relaxation was conducted 50 years ago it remains relevant For example most therapeutic applications of biofeedback Page 13 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary includ
30. ch can be downloaded from our website www qxsubspace com 1 USB Cable 1 Head Strap 1 Limb Strap Manufacturer of Case OKW Friedrich List Strafe 3 D 74722 Buchen Page 50 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Germany Applied Material high impact polystyrene UL 94 HB Manufacturer of Harnesses Sub Contracted to Pentavox Kft Dugonics utca 11 1043 Budapest Hungary Materials used in harnesses vulcanized elastomer 6096 carbon plaque 3096 curing system 7 and oil plasticiser 3 Page 51 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Appendix C Warranty Contract WARRANTY CONTRACT Please refer to the Warranty Contract and contact your Broker Networker Trainer if you have any questions regarding the Warranty Contract 1 Products Cover The device The System and the limb and head harness The straps designed and manufactured by Mandelay Kft The Manufacturer Based on industry standards of the materials used and the fact that the device does not have movable parts the life of the device has been established to be up to 10 years and perhaps longer than 10 years There is no expiration date on th
31. cial computer software documentation as such terms are used in 48 C F R Page 54 of 63 SCIO User Manual 200003 K www qxsubspace com www gqxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary 12 212 Consistent with 48 C F R 12 212 and 48 C F R 227 7202 4 all U S Government end users acquire the software and documentation with only those rights set forth herein Contractor manufacturer is Mandelay Kft ATI Sziget Ipari Park 11 Ep H 2310 Szigetszentmikl s General This contract is effective until terminated It will terminate upon the conditions set forth above or if you fail to comply with any of its terms Upon termination you agree that the Software and accompanying materials and all copies thereof will be destroyed This agreement is governed by Hungarian law Each provision of this agreement is severable If a provision is found unenforceable this finding does not affect the enforceability of the remaining provisions terms or conditions of this agreement This agreement is binding on successors and assigns Mandelay Kft agrees and you agree to waive to the maximum extent permitted by law any right to a jury trial with respect to the Software or this agreement Because this waiver may not be effective in some jurisdictions this waiver may not apply to you You acknowledge that you have read this agreement that you understand it that you agree to
32. d click on Yes Page 28 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary e Sometime it might be necessary to reboot the computer to save changes in the ports configuration e You may install the drivers of the SCIO in all the available USB ports of the computer this way you do not need to remember which port you have configured to be used with the SCIO Part 17 Important Procedure to Complete Installation To finish the installation of the SCIO you must specify what type of interface box you are using From the Windows task bar follow 1 Start Programs Clasp32 NEW 7 Interface type 2 Type your device serialnumber in the box at the bottom of the screen and click Load Number 3 Select the appropfiate interface device and click OK e You only need to do this one time e If you select the wrong type or change your interface box simply repeat this procedure This is necessary because each interface box uses a different Baud rate Part 18 Getting Started The SCIO is a highly intricate and complex systemyand time should be taken to learn and understand the system Here are some suggestions to help you get started broken down in the following sections e Perspectives on Starting with the Program e Basic Principles for Navigation e Core Elements to Practice e Bas
33. dard deviation from the mean reactivity Xrroid The name coined by the developer for the reactivity testing employed at biological speeds Page 42 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Appendix A Accessories Policy ACCESSORIES POLICY All of the company Policies and Procedures are found on our official website www gxsubspace com However as mentioned in this User s Manual under Client Safety Harness Rules and Connections this Accessories Policy is included here The Budapest Home Office can only support the safety and effectiveness of the limb harness LH and head harness HH that is part of the registered device as made by us The only accessories that are registered as part of the original device is the head and limb harnesses that are shipped direct he Budapest Home Office These are marked with the batch where dd equals date and mm equals month e head and limb straps below Page 43 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary The use of any other accessory including head or limb harness is at the risk of the user Please be aware that only the above pictured head and limb harnesses are tested for safety and effect
34. e Miller s attempts to replicate this finding in subsequent years however met with frustration Nevertheless during this time other investigators showed that visceral conditioning through the use of feedback techniques could be demonstrated in man Miller and Dworkin 1974 Page 14 of 63 SCIO User Manual 200003 K www qxsubspace com www gqxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Whether or not Miller s original findings were artifactual or due to complex interactions of variables are still undetermined There is no doubt however that the publication of his early research on visceral conditioning in animals did much to stimulate others to investigate similar issues in man and more sophisticated biofeedback techniques were developed Although less well known H D Kimmel 1960 spent years investigating instrumental conditioning off the autonomic nervous system ANS in man Stimulated by results of earlier experiments in conditioning of the galvanic skin response GSR Kimmel and his students found that subjects GSR s could be conditioned using pleasant odors Kimmel 1974 summarized the research up to 1967 including 16 studies of GSR five of heart rate and three of the vasomotor response Results of all these studies supported the contention that the ANS could be modified through operant conditioning These findings were criticized by Katkin
35. e life of the device as some are known to be using their device since 1997 with no problems The harnesses are considered to be movable parts and therefore have a recommended lifetime of up to 3 years from the first use and are easily replaced The device has a shelf life of up to ten 10 years from the date of manufacture and should be refurbished within that time frame 2 Warranty Cover The Manufacturer warrants to the final workmanship under normal use and se ill be free from defects in materials and described in paragraphs 3 and 4 3 Warranty Initiation The warranty will begin on th The Manufacturer records f proof of purchase must exist in 4 Length of Cover The warranty of The Systen months The warranty of tl Straps Only The Manufa System the straps is for six 6 he System or alters the facturer may repair the 5 Proofof Purchase Proof of Purchase is automatic fr 6 Manufacturer s Actions If The System covered under this w warranty period The Manufacturer will a ace the defective product without charge for parts and labor or provide a replacement in exchang defective The Manufacturer reserves the right to provide at no extra cost a more current upgrade model for replacement if available workmanship during the applicable 7 NotWarranteed I Systems that have been opened by anyone other than an Authorized Service Center or subjected to misuse acciden
36. e the use of a systematic relaxation technique Although Jacobson s system has been modified over time his ideas and research methods have much to offer clinicians and researchers Based on an interview reported by McGuigan he may have been the first researcher to use medical instrumentation to provide feedback about physiological responses Jacobson and McGuigan 1978 His procedure employing a prototype of modern biofeedback instrumentation involved an individual observing an oscilloscope to determine the level of tension in his forearm extensor muscle Later Wolpe 1973 modified Jacobson s technique and popularized it as part of the systematic desensitization procedure In 1958 Kamiya 1969 began to study the changes in Consciousness that accompanied variations in EEG alpha rhythm of human subjects He developed a discrimination conditioning task in which a bell was rung periodically and the subject was requested to indicate if he had been generating EEG alpha just prior to the auditory stimulus Many subjects were able to learn this task and this led to further research of alpha rhythm control Kamiya and his associates later discovered that subjects could suppress alpha when given auditory feedbacke oncerning its presence or absence Although the initial claims of alpha wave train rs were found to be exaggerated research by Kamiya and others continues and m y eventually lead to the development ot more effective clincial methods Due to t
37. ecececcesesesececececsescaeceecceceeeaaeseeececeesaaeceeececsesaaeeeeeeecsensaaeaeeeceeeenenaeea 23 PART 13 2 INSTALLATION ette te dass sess estate gases esset essere rees setate ganas sese eee erenn 24 PART 14 NECESSARY PROGRAMS FOR THE CLASP32 cssssscssssscccssssccsessscccsssscccessseccecsssecsessececessnes 26 PART 15 USB TO USB CABLE INSTALLATION INSTRUCTIONS e eese eren esee eroe etn oeste tn esee en a 27 PART 16 CONFIGURING THE PORT eee ee ee eee eere esee tone ete to sesta sese ee eo Pes seen Pese e ene eee as eese soa e e eese sese soa 28 PART 17 IMPORTANT PROCEDURE TO COMPLETE INSTALLATION ee eene ee ee ee oe een osea tnu 29 PART 18 GETTING STARTED aet es r aoo eoa neto Paene aR o se aepo aa e saa P e SE PE Poo OE EE SE ee PRSE OE UE PR oo OE PE PER e OE ES aea Ur EE ea Ee sE eae eT 29 PART 18 1 PERSPECTIVES ON STARTING WITH THE PROGRAM 29 PART 18 2 BASIC PRINCIPLES FOR NAVIGATION 30 PART 18 3 CORE ELEMENTS TO PRACTICE ee etre ree Vie eebe deed cue eun tack 30 Page 3 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary PART 18 4 BASIC PRINCIPLES FOR CLIENT 30 PART 18 5 TIMBFRAMES eerren erneer i Dese Lee th saves ESEE EE E EE EEA ASEE eE EA NEEE EE EEEE E EIEE 32 PART 1
38. ecompile or disassemble the Software Limited Warranty This warranty is limited to you and it is not transferabley Mandelay Kft does NOT warrant that the functions of the Software will meet your requirements or that operation of the Software will be uninterrupted or error free You assume responsibility for selecting the Software to achieve your intended results and for the use and results obtained from the Software MANDELAY KFT DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE FOR THE SOFTWARE AND ALL ACCOMPANYING WRITTEN MATERIALS This limited warranty gives you specific legal rights you might have others which vary from jurisdiction to jurisdiction IN NO EVENT SHALL MANDELAY KFT OR ITS SUPPLIERS BE LIABLE FOR ANY DAMAGES WHATSOEVER INCLUDING WITHOUT LIMITATION DAMAGES FOR LOSS OF BUSINESS PROFITS BUSINESS INTERRUPTION LOSS OF BUSINESS INFORMATION OR OTHER PECUNIARY LOSS ARISING OUT OF USE OR INABILITY TO USE THE SOFTWARE EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES Because some jurisdictions do not allow an exclusion or limitation of liability for consequential or incidental damages the above limitation might not apply to you U S Government restricted rights The Software and documentation are commercial items as that term is defined at 48 C F R 2 101 consisting of commercial computer software and commer
39. ed in writing complete and exclusive agr communications between The Manufacturer may m ity is understood to be the al or written and all other er Agent nor Employee of uld not be relied upon Page 53 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Appendix D Software License Agreement Mandelay Kft Software License Agreement This is a legal agreement between you the user and Mandelay Kft This agreement covers all Software that is distributed with the SCIO for which there is a separate agreement between you and Mandelay Kft By inserting the DVD with the software in your computer or laptop installing or downloading the Software or using the Software that has been preloaded or is embedded in your computer you agree to be bound by the terms of this agreement If you do not agree with these terms promptly return all Software items disks manuals and packing and delete any preloaded or embedded Software You may use one copy of the Software in only three computers at a time If you have multiple licenses for the Software you may use as many copies at any time as you have licenses Use means loading the Software in temporary memory or permanent storage on the computer Installation on a network server solely for distribution to other computers is not use if but only if you h
40. en tied together at an appropriate length so you can connect your patient with no effort The length can be adjusted according to your needs Page 46 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary The connection of the straps to the cables is now made through banana plugs This way if during the session your patient needs to be disconnected from the harness for any reason you can do so with a simple click trap or ED pi d ures below nm When your patient returns and is ready to go back on the device you simply re connect the patient in the correct way following the colored hints You can either remove th Another exciting advantage of this design is the fact that it increases the duration of the harness life cycle If for whatever reason your harness is damaged you no longer need to exchange the whole harness and purchase a new one The new design allows you to order only the damaged part and replace it the cost of maintenance being significantly reduced Page 47 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary We used the same serial plug for the new harness so it is compatible with the SCIO device We hope that with the ne
41. er Note that the MAXIMUM recommended length of a USB cable is 2 meters 6 feet 7 inches A USB cable longer than this will most likely reduce the communication between the operating laptop and the SCIO If you have installed the Clasp 32 from DVD pene follow the following steps in order to set up this new SCIO emm 1 Leave the DVD in the m 2 Plug in the USB to USB cable It is necessary that the SCIO is connected at this point 3 The Hardware installation wizard will advice you of the new hardware and its dialogue box will pop up 4 The dialogue box will ask you if you want to connect to the Internet Select the last option No not this time The button Next gt will activate Click on it 5 The Found New Hardware Wizard dialogue box will appear Select the Install the software automatically Recommended option Click Next gt 6 A second dialogue box will pop up t6 let you know that the software being installed is not a Microsoft production Click on Continue Anyway 7 Once the installation is complete click on the Finish button 8 The Hardware installation wizard will pop up again and its dialogue window will appear again Please repeat procedure 9 In the Windows task bar the message Your new hardware is installed and ready to use will appear Continue onto the next step Configuring the Port If you have installed the Clasp 32 from the internet dow
42. g or terminology the SCIO system is designed with the sole purpose of e Assisting in facilitating the assessment and evaluation of stress that may be relevant to the client s wellbeing e Assisting in facilitating awareness within the organism of stress to help in the mobilization of the client s stress reduction resources Stress is a medical disease and concern The World Health Organization s International Classification of Diseases 9 ICD 9 lists 308 0 as Acute Reaction to Stress and 308 3 Stress Acute Situational Disturbance and the ICD 10 lists F43 Reaction to severe stress Page 7 of 63 SCIO User Manual 200003 K www qxsubspace com www gqxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary and adjustment disorders and F43 0 Acute stress reaction F43 1 as Post traumatic stress disorder F43 2 as Adjustment disorders F43 8 as Other reactions to severe stress and F43 9 as Reaction to severe stress unspecified The opinion of the word acute is to be made by the therapist or the patient and is not the responsibility of the manufacturer of the SCIO nor this manual nor the SCIO itself Part 3 Indications for Use The SCIO is indicated for use as a Universal Electrophysiological Biofeedback System The Universal Electrophysiological Biofeedback System is made up of the following Eight Universal Items which are functions of the SCIO 1 Stress
43. gs Set the Screen Resolution at 1280 x 800 pixels or bigger if you have a 15 inch screen Power configuration In the Screen Saver set to None click on Power and set all the values to Never 4 Empty the Recycle Bin and restart the computer Disclaimer This document for guidance only Mandela Kft is not responsible in any way for any damages file lost or otherwise caused or derived from or as a result direct or indirect of this information Once the Clasp32 has been installed and activated as well as the recommended programs installed it is advisable to execute this routine so that the computer stays tuned up to better run the Clasp32 Page 22 of 63 SCIO User Manual 200003 K www qxsubspace com www gqxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Part 13 Installation amp Activation Procedure SCIO Please read thoroughly before loading the Clasp32 program into your computer The most current version of the Clasp32 is always available on www qxsubspace com These instructions specifically relate to the most current version of the program Furthermore there are numerous Video Tutorials available on www qxsubspace com for easy reference on the Installation and Activation Procedures Part 13 1 Online Activation In order to provide a more professional S rvice to our customers we are now able to offer 24 h
44. he therapist does not have a license then the therapist can refer to the person connected to the device as a Client Phase Angle Time delay between a stimulating current and the voltage generated by an alternating current of 50 KHZ in the conductive media expressed in degrees of phase shift One complete cycle of current represents 360 degrees so a phase shift of 6 degrees represents a shift of 6 360ths of a cycle or 1 67 Phase Contrast A method of viewing blood for disturbances under a specialized microscope system Proton Pressure An indication of the pressure exerted by the proton content ie Normal target is 65 to 70 Below 2 70 alkaline There is no ic measurement and Purple Color Band yf more than two Reactance C elate he storage of Reactance Speed Inde ad to adjust the get an optimum Reactivity sulting in a score relating ent may place on an item after an exposure af between 1 80 and 1 110 of a second Reactivity Dysfunction See hypo hyperreactivity above Rectified An indication that an energetic disturbance has been repaired according to the way the device measures It does not indicate how long this rectification will hold Red Value Color Band Reflect items that the client has a high reactivity to of three or more standard deviations from the mean reactivity Resistance The component of impedance related to the dissipation of energy in a conductive media Page 41 of 63 SCIO User Manual 200003
45. he unpredictability of the results so far the clinical utility of EEG alpha rhythm training remains problematic Miller 1974 Ancoli and Kamiya 1978 reviewed several areas of controversy surrounding EEG biofeedback For example one unresolved issue is whether or not the reported increases in EEG alpha are due to reductions in visual and oculomotor responding Ancoli and Kamiya reviewed 45 different EEG biofeedback studies from 1968 to 1976 and concluded that a majority of the studies suffered from methodological weaknesses They believed that many negative results occurred because training times were too sbort and experimental conditions were not optimum They suggest that in the future researchers should employ at least 4 training sessions use continuous feedback with quantitive progress scores and use experimental trials which havea duration of at least 10 minutes One of the intriguing areas of investigation concerns the search for empirical validation of visceral or smooth muscle operant conditioning Since 1938 when Skinner could not demonstrate operant conditioning of the vasoconstrictory responses researchers have been interested in this area of learning Neal Miller and his colleagues most notably the late Leo DiCara have been involved in research on instrumental autonomic conditioning in animals for a number of years In 1968 DiCara and Miller observed that curarized rats could learn to avoid a shock by lowering their heart rat
46. here to have the shortcut Click on Next to start the installation e As soon as the installation is finished 2 windows come up The 1st window is the Installation Successful window where you need to click on Finish the 2nd window is the Backup Restore software s 1st screen explained in the next step e The installation is now successfully finished After installing the Backup Restore software you can run it with the Backup Restore for Clasp32 Sqlite icon from the Desktop TO back up your clients you need to go through the following steps e e Run the Backup R store software e The 1st window is a question Do you want to run the BackupRestore software in Paradox mode You have 2 options Yes and No Choose No e The 2nd window is the Backup Restore software You will see 4 buttons Make a Backup Restore Set Folder Close With the Set Folder you can select where your Clasp32 software s Data folder is C Clasp32 Data is the default setting You need to use this button only if you installed the Clasp32 software to a different place e Click on the Make a backup button e Ar this point the backup process begins a small window appears with the following message Backup is Done This marks the end of the process you need to click on OK e Click on Close You have now successfully backed up your clients Part 23 Restoring Client Data To restore the client files saved with the Backup Rest
47. ic Principles for Clients e Timeframes Part 18 1 Perspectives on Starting with the Program We recommend that you keep in mind that the benefits of the SCIO are due to the advances in science and technology It is important to be comfortable with how to use a computer and navigate through the software We highly recommend the following steps to success with your SCIO Page 29 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary 1 If you have no computer experience we suggest you do a short local course in Windows Computers are not difficult but the unfamiliar is often a little daunting Taking time to learn Windows is time very well spent and will accelerate your use of the program 2 Learn to navigate the program Practice practice practice 4 Take advantage of the home study and on line distance learning facilities available from many independent sources If possible get some live training There is no learning substitute for real practice 7 Representatives are authorized to create their own training manuals and multimedia to assist in the learning process but this User Manual is the top level manual from the Manufacturer and must always be referenced as the official reference for all users Em o Hi Part 18 2 Basic Princip Here are a few suggestion inciples of n
48. ients to reduce the tension in their frontalis forehead muscles Their results showed that average muscle tension levels dropped from 10 to 3 5 microvolts and headaches intensity was reduced over the 16 week training period Two control groups of headache clients were employed in the experimental design one group received false or pseudofeedback and the other group received no feedback at all Neither of these groups improved as much as the EMG therapy group Since then the results have been somewhat mixed regarding the effectiveness of EMG biofeedback compared with simple relaxation methods The clinical research which has been reviewed thus far has involved procedures where feedback is used to reduce muscle and blood vessel contraction physiological arousal Page 15 of 63 SCIO User Manual 200003 K www qxsubspace com www gqxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary however a technique to increase muscle contraction a form of EMG biofeedback training has existed for almost 25 years John Basmajian s 1979 early research first published in 1963 indicated that clients can increase the functioning of single motor units through the use of EMG biofeedback Even earlier Marinacci and Horande 1960 demonstrated that EMG feedback could be applied to improve neuromuscular functioning in several disorders Basmajian and his colleages have designed s
49. iveness and are registered with the SCIO We are currently working on updates to the limb and head harnesses for improved comfort and use but this is a timely process as all steps of the manufacture and use have to be in compliance with the current registrations Please note that the Budapest Home Office cannot take any responsibilities for use of any other harnesses and or accessories made by a Third Party Using such harnesses and or accessories are at the user s own risk Please always note that the Third Party is responsible for getting their harnesses and or accessories safety tested by a proper testing body The user has the right to ask the Third Party for a safety certificate of the harnesses and or accessories Please note that as of 1 November 2008 this policy comes into effect However Page 44 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Third Parties are given six 6 months to get the safety certificate Therefore from 1 May 2009 the user should be asking for a safety certificate of harnesses and or accessories Page 45 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary NEW LIMB HARNESS The Budapest Home Office is proud to
50. ll only happen with the Clasp32 at very low RAM e g 512 Mb Thus the program may run but slowly However this is NOT recommended at all The Clasp32 is a large application program running in real time The Operating System Windows does not run in real time The Clasp32 sends a signal to the box Rx light flashes once then box starts to generate the appropriate frequencies Tx light flashes once and then the 8 red lights The SCIO includes its own processor to be able to do this thus the CPU of the computer is free The computer needs a high resource capacity because the Clasp32 Database the core of the program uses the SQ Lite Database engine Due to the phenomenal amount of information generated the database engine has been stretched to its maximum capabilities Other aspect is the image generated animations these require a lot of Advanced Micro Devices Global supplier of integrated circuits for the personal and networked computer and communications markets headquartered in California USA Intel American electronic corporation headquartered in California USA It is the World s major producer of a variety of electronics and computer components including semi conductors microprocessors chipsets and more TT Celeron New computer processor from the Intel Corp Slower than the Pentium chip it was designed for the home computer market in the lower price range Page 20 of 63 SCIO User Manual 2000
51. loaded from www adobe com This software is the global standard for electronic document sharing It is the only PDF file viwer that can open and interact with all PDF documents Use Adobe Reader to view search digitally sign verify print and collaborate on Adobe PDF files Notepad With this program users can write small notes and open small documents 2 Not vital but helpful a b Page 26 of 63 Microsoft Office Suite Besides Word Text editor it contains Access Databases Excel Spread sheets PowerPoint Presentations Norton Utilities This program is very useful to maintain the computer tuned up We have noticed that the great compatibility of this program with the Clasp32 Norton Antivirus This program is necessary to keep the computer free of viruses It is important to remember that this program or any other anti virus program must be installed after the Clasp32 It is always necessary to use an anti virus and a utilities program from the same manufacturer as conflicts may arise Again we recommend Norton Anti Virus and Norton Utilities SCIO User Manual 200003 K www qxsubspace com www gqxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Part 15 USB to USB Cable Installation Instructions Note that the SCIO does not need an external power source as power is drawn directly from the comput
52. monized standards Here is some basic information on electrical safety to ensure that you are fully aware of how to safely and properly use the SCIO Part 6 1 Electrical Safety Elements It is current amps that can kill and not volts House supply is 115 volts USA and 230 volts Europe AC alternating current but with 1 amp 3 amps will usually kill a much smaller dose of even 2 amps directed through the heart can do damage The SCIO works at medically absolutely proven safe micro current milliamps and has safety devices in the SCIO box to stop over current and volts The SCIO is powered by the USB connection to the computer and thus the possibility of harm from mains power supply is minimal further measures re indicated below to conform With safety requirements Please use the SCIO with a computer on battery mode or with aymedically safe circuit breaker surge protector It is fundamental and part of electrical safety legislation to protect the client from harm This can come from two sources that are impossible with proper use of battery or circuit surge breaker 1 A short circuit where electricity passesedinectly to earth ground via the client e g a knife in the toaster 2 A mains surge or lightning strike This cannot occur when the computer is operating on batteries However batteries don t last for long in the computer 1 2 hours Therefore itis practical to work on mains power This dictates that safety equipment is
53. nects the laptop to the SCIO should NOT be more included in this than Zmeters long If you ever chose to use another revision USB cable we recommend that you use a cable that is history no longer than Zmeters 7 April 2009 To include Appendix B information as required by Good Richard Lloyd Note that this Manufacturing Practice GMP date was the revision date to the Operator Manual but this information should be included in this revision history 1 May 2008 Richard Lloyd Page 63 of 63 SCIO User Manual 200003 K www qxsubspace com Tel 36 21 252 3503 HU 1 989 681 1063 USA www qxconference com 27 21 813 6020 SA
54. nloaded version please follow the following steps in order to set up this new SCIO 1 Plug in the USB to USB cable It is necessary that the SCIO is connected at this point 2 The Hardware installation wizard will advice you of the new hardware and its dialogue box will pop up 3 The dialogue box will ask you if you want to connect to the Internet Select the last option No not this time The button Next gt will activate Click on it Page 27 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary The Found New Hardware Wizard dialogue box will appear Select the Install from a list or specific location Advanced option Click Next gt Select browse and search for the folder where you downloaded the Clasp 32 install DVD Select the USB driver folder Click OK Click Next gt A second dialogue box will pop up to let you know that the software being installed is not a Microsoft production Click on Continue Anyway Once the installation is complete click on the Finish button The Hardware installation wizard will pop up again and its dialogue window will appear again Please repeat procedure In the Windows task bar the message Your new hardware is installed and ready to use will appear Continue onto the next step Configuring the Po
55. of It is current amps that can kill and not volts House supply is 115 volts USA and 230 volts Europe alternating current but with 1 amp h smaller dose of even 2 an do damage in Richard Lloyd Part 18 1 section 7 change of the word Operator to User in referencing this manual In Appendix C part 5 proof of purchase was updated to state that it s from the date of purchase Richard Lloyd D 15 May 2009 The Installation Manual 200002 is obsolete The information contained in the Installation Manual is now included in this User Manual The Operator Manual 200003 has been changed to the User Manual The information contained in the Operator Manual is now included in this User Manual Richard Lloyd C 20 March 2009 Effective 20 February 2009 the Clasp32 Software Richard Lloyd Page 62 of 63 www qxsubspace com Tel 36 21 252 3503 HU SCIO User Manual 200003 K www qxconference com 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Note that this date was the revision date to will NOT be included in your shipment from the Manufacturer Maitreya Kft in Budapest Hungary Instead you should get the Clasp32 Software from the Installation your Broker from whom you purchased the SCIO Manual but this information 2 Our experience shows that the USB cable that should be con
56. of 63 www qxsubspace com SCIO User Manual 200003 K www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary 8 10 11 With this online downloading and activation process Part 13 3 Installing the BodyViewer has been removed as this is now part ofthe process explained in Part 13 2 In Part 14 Adobe Reader has been added as a necessary computer program for reading some documents and files Throughout the document any references to Navigation Manuals have been removed This is due to the fact that on screen hints and instructions meet the Essential Requirements to instruct users how to use the software Throughout the manual the word interface box has been changed to SCIO where appropriate ense Agreement under the section Limited Warranty the terms of the software warranty have been removed as they fall under the warranty of the entire system I 9 March 2010 16 17 18 In Welcome Letter on page 5 to remind customers of the change to the software being available online from May 2009 by changing the text to say by downloading and activating the latest version of the software from our website www qxsubspace com Your Broker can help you through this process if it is your first time In the Scope Part 2 to reference the Navigation Manual 200022 DRAFT In the Indications for U
57. of the following terms charge stability which is EEG Volume a measurement of EEG Voltage and Amperage over a course of time skin resistance hydration impedence of the transcutaneous resistance of the skin and redox potential electrophysiological changes during respiration Collectively these Page 8 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary are measurements of VARHOPE voltage amperage resistance hydration oxidation proton and electron pressure The SCIO is for biofeedback use only All claims are for biofeedback only Part 4 Disclaimer The SCIO is to be used as a universal electrophysiological biofeedback system It is designed for stress detection and stress reduction The device does not diagnose any issue other than stress Stress can come from many sources this system uses many multimedia therapies to reduce stress This device also measures client s electrophysiological reactivity which is another way to represent stress Only a licensed healthcare practitioner can diagnose a client The system is calibrated to measufe the very fine and subtle electrical reactions to a group of biological and medical str Ssors The sensitivity is set so fin so as to pick up the earliest sign of distress and issu s related to distress Therefore the results might be below the client
58. olours supplied pack Specifications Power Power Uptake max 100 mA DC Power Input 5 V DC USB Port Generated Signals Any Way You Want Ponalt Negalt See below Output Ports 12 Freely Exchangeable Channels Time of Change of Signal max 300 ms Time of Change of Channel max 100 ms Page 49 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Output voltage 0 4VDC Resolution of output voltage up to 1 596 ofthe final amplitude Accuracy of Output voltage up to 1 5 96 final amplitude Output Resistance min 1 KQ max 5kQ Output Frequency 0 100 kHz Resolution of Frequency 0 1 Hz Accuracy of Frequency up to 1 5 of the measured value Applied Fuse MF RO30 Bourns Self Recepting Fuse Physical Specifications Length 200 mm Width 175mm Height 75 mm Environmental Specifications Operating Temperature Storage Temperature Humidity To reduce the chance urfaces are floors of wood concrete or ce S i erial the relative air humidity should be ne should be touched first to discharge a Fires in fireplaces should not be in use Manufacturer s Data Mandelay Kft TI Sziget Ipari Park 11 H 2310 Szigetszentmikl s Telephone numbers In Europe 36 21 252 3503 In The USA 1 989 681 1063 In South Africa 27 21 813 6020 List of Accessories 1 Software whi
59. on Send to the Server You will be automatically redirected to Paypal Page 23 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary 13 There are two options of paying the activation fee 1 Through a Paypal account 2 Through a credit or debit card if you do not have a Paypal account To do 0 please fill in the form and click on Review order and Continue 14 Click on Pay Now 15 In the next screen click on Return to QX Itd This can be either a link or a button depending on the Paypal site 16 As soon as the payment is complete the following message appears Your computer is activated Congratulations Click on OK to proceed 17 Click OK on the following message to close the program 18 The Software is now ready to use The current activation fee you can find on our website www qxsubspace com If you have any questions or problems regarding this please write to Ibolya Molnar Bodzsar Broker Relations Manager at ibolya qxsubspace com Part 13 2 Installation 1 Switch your computer on and make sure that you are at your Windows desktop and that no other programs are running i In case if you have WINDOWS VISTA or Windows 7 on your computer you need to turn off the UAC User Account Control Please do the following steps a Go into the Control Panel and double
60. ore Program please follow the procedure as outlined below e Run the installed Backup Restore software the Client Backup Tool from the www qxsubspace com under DOWNLOADS SOFTWARE Double click on the Backup Restore for Clasp32 SQLite icon on your desktop to start the program e The 1st window is a question Do you want to run the BackupRestore software in Paradox mode You have 2 options Yes and No This depends from the Clasp32 Page 38 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary software version If your software version is 2009 or older please choose Yes if you have 3 3 2010 or a newer version please choose No e The 2nd window will display the Database type you have Click OK to proceed e Click on the Restore button to restore your client files e The next window is a question Do you want to delete your original patients Please click Yes or No depending on whether you have entered new patients before restoring the Patient Files e Atthis point the restore process begins a small window appears with the following message Restore is Done This marks the end of the process please click on OK e Click on Close You have now successfully rest ored your clients Part 24 We or Refurbishing Your Device For various reasons your device m
61. ould get the Clasp32 Software by downloading and activating the latest version of the software from our website www gxsubspace com Your Broker can help you through this process if it is your first time 2 Our experience shows that the USB eablesthat connects the laptop to the SCIO should NOT be more than 2meters long 3 All users of the device must be registered on our official website www qxsubspace com This ensures that you get the latest information news and updates regarding your device Furthermore this revision of the SCIO User Manual includes the terms of the Warranty Contract Please take a moment to familiarize yourself with your warranty which is automatically initiated based on the shipment date of your device In our never ending search for excellence we work closely with many of our users in the improvement and expansion of the program If after you are familiar with the program you find that the program does not perform a particular function you would like to use please feel free to drop us aline with a thorough but concise explanation of what you would us to consider adding to the program All suggestions will be brought before the Board of Directors for consideration Our software The Clasp32 is by far the largest and best software package in the field of Energetic Medicine today However it is not exempt from a few minor programming Page 5 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference
62. our internet activation Please follow the instructions below and if you have any difficulties please contact you broker for assistance These instructions are for users to activate their own software online If you do not have internet access pleas contact your broker You will be able to pay with PayPal either with your own PayPal account or your credit card 1 Register on www qxsubspace com Sign up 2 Run the SCIO Software by clicking on the Eductor or Clasp32 icon on the desktop 3 Click Close on the SCIO Is Working screen when the program reaches 25 4 On the following screen please click on Continue 5 Then click on Password 6 If this is your first activation on the laptop desktop right after the installation please enter your name and country in the Password screen and then click on I agree to all terms and save 7 Read the installation instructions than click on Close in the Biofeedback device installation instruction screen 8 On the Password screen click on Activation 9 Please choose between the A B or C options and select the type of purchase Enter the purchase date and click on Close 10 Click on Continue 11 The Internet button is always active whether you have Internet access or not If you have Internet access on the computer please select Internet 12 In the Activation window please enter your www qxsubspace com Username and Password and click
63. own the computer crashing Hold the power button for 10 seconds until it shuts down Part 19 3 Restoring a Client This part is only applicable if the program crashes and is closed by using the closing function of Task Manager If you then need to restore a client you will be given this opportunity on restarting SCIO As it opens you will be asked if you want to restore the last client answer yes Enter password details as normal ensure that the correct client displays in Demographics and proceed from where you left off There are also prompts after calibration just to access the last client data on the info panel The scores are correctly restored b ag is often considerably altered Part 19 4 Biofeedb The program as receiv An activation proces accessed is available astration Version only sive facilities to be Page 34 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Part 20 Checking the SCIO Interface The SCIO interface contains the digital interface device a microprocessor and connects together the necessary cabling The power for the LED s lights originates from the USB connection which draws on computer power LED s have a very long life and generally do not fail If a LED does not illuminate as below check connections first If the lights are not functioning there ma
64. peciallly constructed biofeedback instruments for use in rehabilitation e g a miniatue EMG feedback device They have applied such instrumentation to various disorders including paralytic foot drop There is significant difference between the EMG units used in rehabilitation and those adapted for use with psychophysiological disorders The biofeedback units employed in rehabilitation are designed to transmit information about single motor units or the functioning of a specific muscle Most of the EMG units used to enhance relaxation however summate the bioelectrical information of a particular muscle group The resulting feedback is somewhat less specific Prior to 1970 relatively few studies were conducted using biofeedback techniques Since then however hundreds of inv stigations have been done and the accumulation of data has been impressive For thi reason BSA task forces were developed to survey the current literature and summariz the current status of biofeedback as a therapeutic technique in a number of areas including psychophysiological disorders Fotopoulos and Sunderland 1978 gastrointestinal issue Whitehead 1978 vasoconstrictive disorders Taub and Stroebel 1978 muscle tension headache Budzynski 1978 and others In 1989 Nelson proposed and proved that biofeedback need not be just a conscious or verbal process By biofeedback transcutaneous interaction with the body electric or CNS central nervous system the system
65. present the new and more improved limb harnesses for your device designed to be more comfortable and flexible to use while mantaining a high quality level This harness is unique in the market today not only because it offers you simpler ways of working with a patient but because it is using the highest quality in materials and further maintenance In our 20 years of experience in the field of energetic medicine and biofeedback volcanic rubber has proved to be the safest and the most conductive material for the harness therefore we have kept the same material in manufacturing the new harnesses With the covering of the metal part that at the previous model was in direct contact with the skin we have created an even safer harness eliminating the risk of bruises sore or blisters when working with patients with electrical hyper reactivity The new design of the harness will make it more comfortable for you to deal with the patient during the biofeedback session The cables that connect the plug to the straps are now made from a different flexible more resistant and soft material Also you will notice that the bananas are painted the four colors that you have become very familiar with red blue yellow and black colors that indicate which extremity to connect the strap to In the past that was indicated by the small colored buckle located on the straps In order to prevent tangling of the harness and provide easy handling the cables have be
66. recognition The readings should be evaluated by trained biofeedback technicians Always consult with a licensed healthcare practitioner Always use additional tests or referrals No claims other than stress detection and stress reduction may be made Part 5 Client Safety The information here is very important and this information should always be readily available Following these important instructions is vital to ensuring safe use of the device If you have any questions please contact your Repr sentative Part 5 1 Operation Instructions Read all of these instructions in this User Manual Save them for later reference Follow all Warnings and Cautions marked on the product and included below Unplug the device from the USB cable before cleaning it DO NOT use this device near water DO NOT place this device on an unstable cart stand or table DO NOT allow anything to rest on the USB cord NDANE Part 5 2 Warnings In following with the Essential Requirements of a medical device Warnings must be clearly worded and stated to ensure the safe use of the device Therefore the following Warnings Page 9 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary have been established based on our Risk Analysis and must be implemented in your use of the device If you have any questions please
67. rranty breach of contract negligence strict tort or any other legal theory such damages include but are not limited to loss of profits loss of savings nor revenues inability to use The System or any associated equipment cost of capital cost of any substitute equipment facilities or services claims by Third Parties other than The User and injury to property 8 Warranty Service If The System requires warranty service The User must first contact an Authorized Service Center through the User s online account with www gxsubspace com to order the service The System must be returned at the cost of The User along with a description of The System malfunction or difficulty and the address where The System must be returned Warranty status must be substantiated as explained in paragraph 5 The Manufacturer assumes no risk for damage or loss in shipment If in The Manufacturer s sole opinion The System failure is not covered under this warranty The User will be notified and an authorization will be requested for any further repair activity The System repaired under warranty will be returned to The User at the cost of The Manufacturer If The System is repaired and it is not under warranty it will be returned to The User at the cost of The User Judgment on all situations and or o in paragraph 7 will be left to the discretion of The Manufacturer A d absolute 9 Agreement Unless modifi
68. rt Part 16 Configuring the Port Before setting up the COM P ft please make sure the driver ofthe device is properly installed The following steps will guide you to Set the communication port to COM1 1 Av PWN 7 8 9 10 11 12 13 14 On the Windows XP or Windows Vista desktop right click on My Computer If you cannot find this icon on the desktop open the Start menu and look for the Computer icon there and right click on it Select Properties Select Hardware Select Device Manager Select Ports Right click on the port that corresponds to the one where the drivers for the cable has been installed i e USB SerialPort COM XX Select Properties Select Port settings Select Advanced In COM Port Number select COM 1 Click OK in all Windows to return to desktop Go the Device Manager to check changes have taken place i e USB Serial Port COM 1 Always connect the USB to Serial cable to the same USB port you have just configured It is possible to sometimes see that the COM 1 in use when in reality nothing is attached to it Select the Port anyway and click OK The message This COM name is being used by another device such as another port or modem Using duplicate names can lead to inaccessible devices and changed settings Do you want to continue Simply ignore the message an
69. s radios electro static air cleaner and other such devices a minimum of 1 5 meters out of the device s radius This will reduce the potential for outside interference However it is possible to keep the operating computer within this 1 5 meter radius with the recommendation that the Wi Fi ability of the computer is turned off Disturbances are possible Page 19 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Part 11 Computer Specifications for the Clasp32 SCIO This page will inform you about computer memory size speed and other requirements that are best compatible with the SCIO Part 11 1 Cache and RAM Random Access Memory The difference between the different CPUs Central Processor Unit is the speed and the cache The memory built into the processor itself An AMD CPU normally will perform faster than an Intel CPU at thesame speed The Celeron CPU normally has less cache The Clasp32 Softwarefrequired by the SCIO will first look for the space it needs to perform in the cache memory this is extremely fast If it does not find enough space it will go to memory built into the memory on the motherboard slower but still fast This is the RAM If it still does mot find the space there it has to go the hard drive Slow and execute the instructions This however wi
70. se Part 3 to use the same Richard Lloyd Page 58 of 63 www qxsubspace com Tel 36 21 252 3508 HU SCIO User Manual 200003 K www qxconference com 1 989 681 1063 USA 427 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary wording for the Indications for Use as in Clinical Evaluation CT 103 05 19 In Symbols on the Device Part 10 to make the years numbers and revision letters generic so that this part does not have to changed if there is a change in the label for example in Manufacture Date 20 In Good Manufacturing Practice GMP Information in Appendix B adding the Manufacturer of the Harness as well as the materials used in the harnesses 21 Clarification of biofeedback transcutaneous interaction with the CNS in Part 5 4 and 9 22 In Appendix B the word Celsius written next to the Environmental Specifications ollowing per Table O keep any other 0 as cell phones radios electro static air cleaner and other such devices a minimum of 1 5 meters out of the device s radius This will reduce the potential for outside interference However it is possible to keep the operating computer within this 1 5 meter radius with the recommendation that the Wi Fi ability of the computer is turned off Furthermore the following has been added Disturbances are possible near devices with the Co following symbol A 25 The following Definitions have been added in
71. some patients have experienced these undesirable side effects e A slight feeling if light headedness after a session Please note that this may be due to the patient s own health such as high blood pressure or the sudden standing up after being in a relaxed reclined position during the session If this feeling feels in any way abnormal or of a concern then the patient should see their primary healthcare practitioner e Through biofeedback transcutaneous interaction with the CNS the SCIO may induce an autonomic nervous system cascade that can lead to a vasovagal crisis The patient might sweat excessively report nausea and dizziness If this occurs place a cool wet rag over the eyes gently with light pressure tell the patient to relax breathe Page 10 of 63 SCIO User Manual 200003 K www qxsubspace com www gqxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary deeply and wait about 5 to 10 minutes for the vasovagal storm to pass In extreme cases there might be syncope e Some patients are highly sensitive to certain plastics rubbers or metals These are usually people who do not wear a lot of jewellery and who do not use a lot of lotions or perfumes Some patients have noted a slight redness of skin where the harnesses were connected to the patient If this of concern then the patient should consider returning for another session until they see their primary
72. ssadssoseesesisessessssvsessodssscssasedesss 8 VH PES DISCLAIMER L ONS ro bo 9 PART 5 CLIENT SAFETY e c 9 PART 5 1 OPERATION INSTRUCTIONS 5 erret a eer eo RE soa coecdesusaaeeanecsucdusvesadonk E RE Ee Eu EVE REV POE ES PART 5 2 WARNINGS CES PART 5 3 AER Ne EE PART 5 4 UNDESIRABLE SIDE EPPO TS parc E EE E EREE ETE PART 5 5 HARNESS RULES AND CONNECTIONS eere ener nnne PPa eo es PART 5 6 HARNESS CHECK LIST PART 5 7 CLEANING THE HARNI PART 6 ELECTRICAL SAF den a ERE ED 12 PART 6 1 ELECTRICAL EE WEE 12 PART 6 2 CONNECTING THE SYSTEM ecce et uert rtt teee enn a 12 PART 6 3 CLEANING T NESE RRC eee ee A POE Oo BERTA 13 PART 6 4 X RAY EXP BEE eech 13 PART 7 COPYRIGHT E e 13 PART 8 ACCURACY eerte eene Beton 13 PART 9 A BRIEF HIS m SE 13 PART 10 SYMBOLS cccsccsssssssessscessestbnesessevees is EE V ONT T 18 PART 11 COMPUTER SPE 20 PART 11 1 CACHE AND RAM RAND E UMS 20 PART 11 2 COMPUTER SPECIFICATIONS 8999999955 229 NEEN memes ense nenne 21 PART 12 COMPUTER PREPARATIONS FOR THE CLASP32 SCIO eee eese eee esee ee neon neos et tnu 22 PART 13 INSTALLATION amp ACTIVATION PROCEDURE SCIO e eere esee eee eese tones eo esee tn a 23 PART 13 1 ONLINE ACTIVATION cccccccecsssssc
73. t and physical damage improper installation abnormal operation or handling neglect inundation or fire II Systems that have been damaged due to repair alteration or modification by any other than an authorized representative of The Manufacturer UL Defects caused by components parts or accessories not compatible with the warranted System IV Systems whose warranty quality product serial number electronic serial numbers stickers or plates have been removed altered rendered illegible or tampered with V Accessory items and Consumables VI The shipping costs to and from an authorized Service Center or The Manufacturer is not covered Any other warranties including but not limited to the implied warranties of merchantability and fitness for a particular purpose shall be limited in duration to the duration of this warranty Page 52 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary The Manufacturer assumes total liability for damages for any cause related to or arising out of the use or inability to use The System whether in contract negligence strict tort or based on any other legal aspect shall not exceed the original price paid for The System In no case shall The Manufacturer be liable for any indirect special incidental or consequential damages based upon breach of wa
74. the body through electrodes in head and limb straps providing an accurate and precise picture of the client s general status This information is selected and listed by the SCIO in order of the highest reaction and the stressors are analyzed in the course of a stress management session Part 2 Scope This User Manual is created by the manufacturer Mandelay Kft It supplies the basic information and operation of the SCIO software and device interface This manual does NOT provide medical interpretation or medical advice in any way This is a basic User Manual instructing the user on how to get started with the device and basic important information Any statement within the manual is not intended to indicate a medical claim or diagnosis or therapy facility for a specific condition The use of any facility described should not be considered as approaching or substituting in any way for medical advice diagnosis or therapy Clients and users of the SCIO should exercise due diligence in ensuring that they are informed and consult with a licensed healthcare practitioner Any statement within the manual is not intended to indicate a diagnostic claim Only a licensed diagnostician can diagnose with any information available under the diagnostician s expertise The device is for medical biofeedback therapy only The device is intended for stress detection and stress reduction biofeedback therapy In all locations independent of any specific wordin
75. uli This is the end of a very brief history of Biofeedback If you are interested in researching this topic further there is numerous information available Page 17 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Part 10 Symbols As you look at the biofeedback box itself you will see the following symbols Here is an explanation of the meaning of the symbols On the bottom ud Symbol for MANUFACTURER Lyyyy IHHHBIE x AN Ce On the back Symbol puli DATE OF MANUFACTURE with year of digit Notified D TYPE BF APPLIED PART It stands for the classification of a 4 permissible filtered current as well as assurance of grounding for safety regarding this current The Serial Number found on the back of the device is in the following format SXxxxxxxxxxx Page 18 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Only to be included in this User Manual as these are only a recommendations and not requirements Ll o e e e ee For the best optimum performance it is recommended to keep any other electronic equipment such as cell phone
76. used This is what is referred to as a Medical Transformer Essentially the protection can be afforded using specific components Short Circuit a RCD Residual current Device Detector or ELB Earth Leakage Breaker normally available at 30 ma Lightning Mains Surge a surge protector board available from computer shops Part 6 2 Connecting the System Power supply 1 Plug the USB from the computer to the SCIO 2 Connect the computer to mains power via the electrical safety devices Page 12 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary 3 From the Mains Socket to the RCD ELB to the Surge Protected Plug Board to the Computer Part 6 3 Cleaning the device The device may be cleaned periodically as needed with a similar compound used to clean the harnesses It is not necessary to clean the device after every client To clean the device use either peroxide or alcohol The recommended concentration is 1096 alcohol or 3 to 596 peroxide solution for the harnesses and it is recommended to use the same concentration to wipe down the outside of the device Part 6 4 X ray Exposure The device is designed to withstand some X ray exposure We estimate about 50 fifty normal X ray checks We believe that after 50 fifty X ray exposures the device should be refurbished Customers would noti
77. w model of the limb harness we have improved the quality of your work with the SCIO Universal Electrophysiological Biofeedback System so that you and your patients will be able to enjoy these advantages and have a more pleasant biofeedback experience We are con iving to offer you the highest quality in services and products and bri icine today Page 48 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary Appendix B Good Manufacturing Practice GMP Information The following general information is required in following with Good Manufacturing Practice GMP Information on Disposal for Users of SCIO The SCIO device you are using is an electronic product that should not be mixed with general household waste For proper therapy recovery and paises please take this device to designated collection points where they may be accepted o adelay Kft TI Sziget Ipari Park 11 p H 2310 Szigetszentmikl Disposing of this produe potential negative effe arise from inappropri ources and prevent any Which could otherwise For users in the E contact Mandelay K information ic equipment please mikl s for further Function of Banana a For electrodes which is class onitoring Electrode 15 F9042M4 connector cables for clip ele of 6 pieces g 8 different c
78. y be a problem with the computer settings and not with the device Check that the UAC is turned off as explained in Part 13 2 above and check that the COM port settings are correct as explained in Part 16 above If there is a LED issue then the device may be be sent to an authorized Service Center listed under Policies amp Procedure in the Service Center Policy Power on All LED s will flash brie powered on an audible beep when the SCIO is Program Opening a S Calibration all illu Test all except Tx ilh Therapy The daVi ith the Rx and Tx illuminating at interv Green LED power The SCIO is connecte The SCIO is switched ox LED Integrity All LED s will flash briefly when the SCIO is powered on Rx and Tx LED s Rx receiving indicated that signals are being sent to the client Tx transmitting indicates that client transmissions are being monitored signals are being received from the client The Rx and Tx LED s will flash briefly 1 On power up 2 When the SCIO has been found by the program on opening Red Channel 1 8 LED s Page 35 of 63 SCIO User Manual 200003 K www qxsubspace com www qxconference com Tel 36 21 252 3503 HU 1 989 681 1063 USA 27 21 813 6020 SA BUDAPEST HOME OFFICE BHO Budapest Hungary These indicate the communication channels that are in operation The number of LED s that illuminate will depend on the specific program aspect in operation The DaVinci

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