Primus DB. Instruction Manual. Version 2,4. Version 2.4

Transcription

1 Primus DB Instruction Manual Version 2,4 Version 2.4

2 PRIMUS Instruction Manual 2 Instruction Manual PRIMUS - In order to use the system correctly, please read this Instruction Manual carefully. Please do not use any methods not described in this manual. Please always keep this manual at hand for reference when operating the system. In case of loss of this manual, please contact the vendor. For any questions about this manual or about the system, please contact your LACE representative or vendor. (Refer to the attached list of LACE representatives.)

3 PRIMUS Instruction Manual 3 Indications: The LACE PRIMUS is intended for use whenever electrophysiological diagnostic is required. Contraindications: Do not use the PRIMUS for testing people with epilepsy or photogenic epilepsy.! Danger Do not disassemble or remodel the system. There is a danger of direct high voltage. Do not connect the ground cable of the system to a gas line due to the possibility of fire or explosion.! Warning Always disinfect the electrodes before use. When performing maintenance on the system, unplug the power cord.! Caution Attempt to minimise the amount of that the corneal electrode is on the patient's eye. Do not use a corneal electrode that has scratches or cuts on the surface. Place skin electrodes only on intact skin. During use, lock the wheels of the equipment cart and the motorised lift table. When moving the system, make sure that lift table is lowered to it's minimum height.

4 PRIMUS Instruction Manual 4 Symbols used in this manual: The following symbols represent these messages:! Danger High probability that serious injury, or even death, could result.! Warning Possibility that serious injury, or even death, could result.! Caution Notes Risk of slight injury or material damage. Special notes on company policy related, directly or indirectly, to personal safety or protection of goods.

5 PRIMUS Instruction Manual 5 1 Before using the system Cautionary notes Explanation of Terms Component list and functions...12 Computer Operator Monitor Full-field Rear panel connector of the full-field Connection Box Equipment Interconnections Rear panel connections of the computer and Insulation Trasformer Method of Operation Cautionary Notes Related to Safety Starting the system Executing the PRIMUS software NEW PATIENT Oscilloscope and Impedance Acquisition Mode Analysis Mode Save Acquired Data Display stored traces on Screen Setting your own parameters Amplifier Settings Stimulator settings Acquisition Parameter Default settings Preparation for testing Cleaning the Skin Electrodes Disinfecting corneal electrodes Storing elelctrodes Preparation for Recording Preparation for recording Flash and Flicker ERG Preparation for VEP Recording Preparation for EOG Recording Preparation for ENG Artefacts in Electrophysiologic Testing Artefacts Generated by the Subject Artefacts Generated by the Recording Equipment Artefacts Generated by the External Environment Principal Artefacts and How to Limit or Minimise Them How to Deal with Artefacts Using System Features Maintenance Warranty Cleaning Electrodes Electronic Equipment Replacement of Supplies Storage Packing Materials Specifications Optional Accessories...65

6 PRIMUS Instruction Manual 6

7 PRIMUS Instruction Manual 7 This product is intended for use only by licensed practitioners and trained technicians within a medical environment. Purchase of this instrument constitutes acknowledgement of this intention and fulfilment of the requirements contained therein. LACE will not be held responsible nor accountable for any actions resulting from misuse outside of the above named parameters. 1 Before using the system. Notes In order to use the system properly, please read the instruction manual carefully. Please do not operate the system by any methods not described in the instruction manual 1.1 Cautionary notes! Warning Avoid application of electrodes to patients with contagious diseases. If necessary to apply electrodes to such patients, carefully clean, disinfect and sterilise electrodes following use.

8 PRIMUS Instruction Manual 8! Caution Persons without experience should not operate the system When setting up the system, please follow these instructions: Do not place the system near water. Place the system in astable environment with good ventilation and without excessive air flow, temperature, sunshine, humidity, dust, salt or sulphur. Avoid chemicals and flammable gases. Ascertain that factors such as excessive slope, vibration and impact with not endanger the system (including during transportation). Make sure that a proper power source (frequency, voltage and capacity) is used. Before using the system: Ascertain that the ground wire is properly connected. Ascertain that all cables and cords are fully and properly connected. Please observe the following during usage: Attempt to minimise the amount of that the contact lens electrode is on the patient's eye. If complications or abnormalities are found in either the patient or the system which indicate that continuation of the examination is not safe, stop the examination and make sure the patient is unharmed. If during testing the patient experiences dizziness or nausea or feels unwell, terminate stimulus presentation and discontinue testing. Please use caution in interpreting PRIMUS results.

9 PRIMUS Instruction Manual 9! Caution Please note the following after usage: After testing, turn off the power switch. Do not apply excessive force when plugging and unplugging the power cords. When removing the plugs from the outlet, pull on the plug, not on the cord. Clean and disinfect the electrodes, so that they are ready for subsequent use. Please refer to section 5.4 for storage instructions. In event of mechanical or electronic malfunction, do not attempt to repair. Contact a Lace representative. Do not modify the system. Maintenance: If the system has been idle for a long period of, verify that the system is functioning properly before performing a patient examination. Turn off the power switch and unplug the power cord for system maintenance. List of Components Please confirm that all components are undamaged upon unpacking. Please notify the vendor if there are any missing or damaged items Notes Keep the boxes and packing material for future transporting of the system. List of Components IBM compatible PC 1 Mouse 1 Keyboard 1 15" Operator Monitor 1 Full-field 1 Connection Box 1 Silver skin electrodes 5 Corneal electrodes 2 Conductive paste 1 PC - Connector 1 Power Source Cords 3 Instruction Manual 1

10 PRIMUS Instruction Manual Explanation of Terms Icon Small picture that represents various types of applications and files. Click The operation of quickly pressing and releasing the mouse button, with the pointer indicating the desired function. Close Box A small box at the left of the title bar, when clicked, the window will close. Desktop The main computer work area which appears on the monitor. Items on the desk top can be moved or deleted; new items can be added. Dialogue Box A box that indicates messages. In Windows 95, dialogue boxes present potions, request choices, display error messages, etc. Double click The operation of clicking the mouse button twice in rapid succession, with the pointer indicating the desired function. Drag The operation of holding down the mouse button with the pointer on the desired icon and moving the icon to another location by moving the mouse. Folder A location where files and programs are stored. Folders can be stored within folders. Highlight Enhancing a portion of the screen to select its contents. Menu Bar Located just below the title bar, the menu bar contains the available meuus from which commands can be chosen. Pointer A small arrow that represents the mouse position on the screen; when the mouse is moved, the pointer moves correspondingly. The pointer is used in choosing operations, moving data, drawing graphics, etc. Title bar Located at the top of the window, the title bar shows the name of the application, document, directory or file. The window may be moved by placing the pointer on the title bar and dragging. Window One of a number of areas into which a computer screen can be divided, each of which is used to show a particular type of information Windows can be enlarged, reduced, closed, opened, etc.

11 PRIMUS Instruction Manual 11 Explanation of ERG/VEP/EOG terms that appear in this manual 50/60 Hz Interference due to a alternating current which originates from the Noise power source and can contaminate the ERG record. S/N Ratio The ratio of the amplitude of the ERG signal (S) to the amplitude of the noise (N).

12 PRIMUS Instruction Manual 12 2 Component list and functions 2.1 Computer Floppy Disk CD -ROM 2.2 Operator Monitor Removable Harddrive The Harddrive can be easily removed from the main body of the PC ON/OFF Switch Power Indicator Show if the computer is ON Harddrive Indicator Indicates that the harddisk is in use Reset button Pressing this button resets the computer.

13 PRIMUS Instruction Manual Full-field EOG Fixation targets L/R Filter Insertion VEP Monitor 2.4 Rear panel connector of the fullfield Personal Computer Fuse & Voltage selector Connection box Ground connector ON/OFF Switch Power cord 2.5 Connection Box Reference 2.6 Equipment Interconnections Ground Active

14 PRIMUS Instruction Manual Rear panel connections of the computer and Insulation Trasformer Primus Ganzfeld Dome SAT INPUT CH 3 / 4 Connector for electrodes box Video board OUTPUT P.C. Monitor SAT Light sensor External trigger ON/OFF External trigger INPUT SAT ON/OFF SAT Light Level Pre set

15 PRIMUS Instruction Manual 15 P.C Power Supply. Fuse and voltage selector Printer Power Supply Mains Switch Ground Power cable Ganzfeld dome Power Supply 3 Method of Operation 3.1 Cautionary Notes Related to Safety! Warning! Caution Always disinfect the electrodes after use. Attempt to minimise the amount of that the contact lens electrode is on the patient's eye Do not use a contact lens electrode that has scratches or cuts on the surface. The system is to be used exclusively for the purpose of ophthalmic diagnosis and/or research. During operation, be careful not to interrupt the power supply (for example, by stepping on the power cords or power strip on/off switch), as this might cause the system to crash.

16 PRIMUS Instruction Manual Starting the system Please observe the following order, when turning on the power supply. Notes If the proper order is not followed, the system might not work correctly. In these circumstances, turn the system off, and repeat the procedures. 1.Confirm that the system and it's components is wired up correctly. 2.Confirm that there is no floppy disk inserted in the disk drive. 3.Turn the computer, monitor, printer and the on. 4.Wait until Windows95/98/ME has booted. 5.Double click the Primus icon with the left mouse button.

17 PRIMUS Instruction Manual Executing the PRIMUS software From Windows desktop click the relative icon named PRIMUS DB, in order to start the related application software. The following main menu will be displayed, then you can choose one between the following functions: Proceed with new examination ERG, PERG, VEP, EOG, ENG. PATIENTS LIST EXAMINATIONS LIST Proceed with new examination ERG, PERG, VEP, EOG, ENG. Click on the icons ERG VEP PERG EOG ENG to proceed directly with the choice of examination. Patient data panel will be displayed before start examination in order to be filled with the patient data, name, date of birth, sex etc Not filling in patient data, the software will automatically add the patient under the term Unknown in order to proceed the examination. Once you have selected a test category, the system will give you a choice of standardised ISCEV (International Society of Electrophysiology of Vision) tests.

18 PRIMUS Instruction Manual 18 You are free to define and safe your own recording parameter. The user defined preselections can be modified and changed at any during the course of the examination. The default preselections can also be changed, but can not be stored, nor can the default setting be deleted from Fig NEW PATIENT Fill in data of new patient. The following window will be displayed in order to be filled in with new patient data Oscilloscope and Impedance The system will automatically enter the "Oscilloscope mode after one of the listed examinations is selected. It is possible to enter the "Oscilloscope Mode" at any.

19 PRIMUS Instruction Manual 19 The purpose of the "Oscilloscope Mode" is to look at the incoming signals. The incoming signal should be a steady line with only a few over riding waves. If this is the case you can almost be sure that the patient is relaxed and that there are almost no muscle artefacts which are distorting the Fig To check the Impedance between the electrodes select the icon (1). The impedance display shows each electrode impedance value. The impedance values for the positive (ACT.)and negative (REF) electrodes are referenced to the common electrode (GND). All electrode impedance should be less than 5 KOhms and be within 3KOhms of each other. Electrode impedance above 5 KOhms should be reduced. Electrode impedance that are not within 3KOhms of each other should be adjusted. When the impedance is less than 5KOhms the red dot turns to green. Fig 1.6 A reading of 100 KOhms suggests there is an open circuit. Check that the electrode is firmly attached to the skin and the lead is connected to the appropriated jack. If the impedance is still at 100KOHMs, the electrode may be faulty and should be replaced. To exit from the impedance mode press OK

20 PRIMUS Instruction Manual Acquisition Mode To enter the "Acquisition Mode" move the cursor to "Acquisition" and click on the left mouse button. Before starting the examination inform your patient about your intention to start with the recording and ask them to remain calm and relaxed until the examination is completed. Move the cursor to "START" and click the left mouse button. In order to measure the latency and/or the amplitude during Acquisition click and drag with the left mouse button the square located on the yellow vertical line and move it to the area of interest. The latency and amplitude values will be displayed in the XY -box 1

21 PRIMUS Instruction Manual Analysis Mode In the following all of the possible functions available in the Analysis Mode will be described. Data can be stored or retrieved in the Analysis Mode. The scale of the traces can be adjusted to fit the size of the display. Cursors mark the amplitudes and latency which are of interest to the user. In order to measure the latency and/or the amplitude at a point of interest, click and drag the cursor with the left mouse button. In order to select another trace point the cursor to arrow Up an Down and click the left mouse button. The cursors will then jump from the previously selected trace to the selected trace. In order to move the trace to another location on the screen, click and drag the trace with the right mouse button.

22 PRIMUS Instruction Manual Save Acquired Data The PRIMUS program will automatically prompt whether or not you wish to store the acquired data before going to the next examination category. To store the acquired data from within a examination select File from the task bar and select Save Acquired Data.

23 PRIMUS Instruction Manual Display stored traces on Screen PATIENTS LIST Alternatively click the icon which is named "Patients List" in order to display the following panel. You can perform the followings functions: SEARCH LAST NAME EXAMINATIONS LIST SET AS CURRENT NEW PATIENT SEARCH LAST NAME Select one patient by input some relevant letter or writing the complete name of the patient. You can also select one patient by click on the names list as above show. SET AS CURRENT Assume the selected patient as current patient for the following examination. The name of the selected patient will be add on top of Primus Main menu.

24 PRIMUS Instruction Manual 24 EXAMINATIONS LIST Proceed the examination of selected patient after selecting the examination required from the following displayed panel. You can select one examination by clicking on it. You can read stored notes together with the examination. Traces of relative examination will be automatically displayed in to the preview panel. NEW PATIENT Fill in data of new patient. The following window will be displayed in order to be filled in with new patient data.

25 PRIMUS Instruction Manual 25 EXAMINATIONS LIST You can choose Examinations list button to perform the followings functions: CURRENT PATIENT ALL PATIENTS SELECT ALL Option: ERG, PERG,VEP CURRENT PATIENT It will display the examinations of current patient. You can select one of them, and automatically it will display the preview of notes and traces. ALL PATIENTS It will display the examinations of all patients. You can select one of them, and automatically it will display the preview of notes and traces. Option: ERG, PERG,VEP Sorting examination by ERG PERG VEP.

26 PRIMUS Instruction Manual 26 You can select one examination by clicking on patient name, patient examination or date of examination. Automatically stored data and traces preview will be displayed. SELECT ALL Assume the selected examination as current examination in order to be analysed or printed. The following panel will be displayed.

27 PRIMUS Instruction Manual 27 Primus Network PRIMUS DB runs under network connection. Retrieves patient data and examination, analyse, printing, export data of patient examinations. Run Primus DB Browser From Windows desk top run the application software PRIMUS DB on Client PC. PRIMUS BROWSER provides the same function available on PRIMUS BD installed on PRIMUS system:

28 PRIMUS Instruction Manual 28 SET PATHWAY Start Primus Program from remote client PC. Click on File from Primus Menu. Click the relevant key FILE then Set Pathway. The following Panel will be displayed. Selec the right pathway trough the network connection serching for PRIMUS DB folder located in to the Server (Primus System). Generally C:/PRIMUSDB then click DONE The new pathway will be stored and will be available for the next connection.

29 PRIMUS Instruction Manual 29 PATIENTS LIST Double click the icon named "Patients List" in order to display the following panel. Choose Patient list and it will show the followings functions: SEARCH LAST NAME EXAMINATIONS LIST SET AS CURRENT NEW PATIENT

30 PRIMUS Instruction Manual 30 SEARCH LAST NAME Select one patient by input some relevant letter or writing the complete name of the patient. You can also select one patient by click on the names list as above show.

31 PRIMUS Instruction Manual 31 EXAMINATIONS LIST Proceed the examination of selected patient after selecting the examination required from the following displayed panel. You can select one examination by clicking on it. You can read stored notes together with the examination. Traces of relative examination will be automatically displayed in to the preview panel. EXAMINATIONS LIST You can choose Examinations list button to perform the followings functions: CURRENT PATIENT ALL PATIENTS SELECT ALL Option: ERG, PERG,VEP CURRENT PATIENT It will display the examinations of current patient. You can select one of them, and automatically it will display the preview of notes and traces.

32 PRIMUS Instruction Manual 32 ALL PATIENTS It will display the examinations of all patients. You can select one of them, and automatically it will display the preview of notes and traces. Option: ERG, PERG,VEP Sorting examination by ERG PERG VEP. You can select one examination by clicking on patient name, patient examination or date of examination. Automatically stored data and traces preview will be displayed.

33 PRIMUS Instruction Manual 33 SELECT ALL Assume the selected examination as current examination in order to be analysed or printed. The following panel will be displayed. 3.4 Setting your own parameters Before you can set your own parameter you have to make adjustments in the following tables. After selecting the required parameters for the Amplifier, Acquisition Parameters and for the Stimulator save the setting using Save Preselection.

34 PRIMUS Instruction Manual 34 Amplifier Acquisition Parameters Stimulators

35 PRIMUS Instruction Manual Amplifier Settings This selection is used to change the amplifier gain or filter settings for the protocol. In order to modify the amplifier settings you first have to select a channel before making any changes. These changes will not be stored unless a new preselection is stored as described above. Channel: The menu will present choices for 4 channels. If you have a 2 channel system, the settings for channnels 3 and 4 will be ignored. Amplification: There is a selection of five different gain selection available. The gain depends largely on the kind of electrode being used and on the kind of test which needs to be preformed. Y-Magnification: You can magnify or minify waveforms by setting a default value. To change the apparent amplitude of the waveform, change the value of Y-Magnif. Low Pass: There is a selection of four different filter settings. The Low Pass filter will enable frequencies to pass through which are below the selected value. High Pass: There is a selection of three different filter settings. The High Pass filter will enable frequencies to pass through which are above the selected value. Disable Notch Filter: By disabling the Notch Filter you are allowing the signal to be contaminated by 50/60 Hum noise coming from the mains power. Enable Acquisition: Needs to be selected in order to obtain a acquisition using the selected channel. Reject Artefact: The Artefact Rejection, when activated, discards all the input signals exceeding the selected amplification range on the selected channel. Hide Trace: Label:

36 PRIMUS Instruction Manual Stimulator settings The parameters for Pattern, Flash LED, and Goggle can be set according to the user's specification by selecting one of the stimulators and specifying the parameter Acquisition Parameter The Analysis is the recording interval after the stimulator has been started by the unit. The Pre-Trigger function allows to get the patient's physiological signal before the stimulation starts. The Post-Trigger function allows to ignore the patient's physiological signal after the stimulation has started. The Number of Events is the number of traces to be averaged in order to obtain the final curve. The curves discarded by means of the artifact rejection are not included in the averaged result. Discard Events will not average the first few sets of data depending on the amount selected. The Preadaptation function can be used to either light or dark adaptate the patient prior to starting the recording. With Background Intensity you can adjust the amount of light needed to adaptate the patient.

37 PRIMUS Instruction Manual Default settings Rod Response Amplifier Channel Gain Y - Magn. Low Pass High Pass CH 1 5K 1,0 300 Hz 0,3 Hz CH 2 5K 1,0 300 Hz 0,3 Hz CH 1 CH 2 Dis. Notch Filter - - Enable Acq. Reject Artif. Hide Trace Stimulator Full-field Dome Flash Strength (cd/m2 2 cd/m2 Bkg. Intensity 0 Flash filter 2,5 ulog Flash frequency (Hz) 0,3 Hz Acquisition Parameters Acquisition Time 204,00 ms Number of Events 3 Pre-adaptation (min) 0 Post Trigger (ms) 0 Discard events 0 Pre - Trigger (ms) 0 Background Intensity 0

38 PRIMUS Instruction Manual 38 Maximum Combined Response Amplifier Channel Gain Y - Magn. Low Pass High Pass CH 1 5K 1,0 300 Hz 0,3 Hz CH 2 5K 1,0 300 Hz 0,3 Hz CH 1 CH 2 Dis. Notch Filter - - Enable Acq. Reject Artif. Hide Trace Stimulator Full-field Dome Flash Strength (cd/m2 2 cd/m2 Bkg. Intensity 0 Flash filter None Flash frequency (Hz) 0,1 Hz Acquisition Parameters Acquisition Time 204,00 ms Number of Events 3 Pre-adaptation (min) 0 Post Trigger (ms) 0 Discard events 0 Pre - Trigger (ms) 0 Background Intensity 0 Oscillatory Potentials Amplifier Channel Gain Y - Magn. Low Pass High Pass CH 1 5K 4,0 300 Hz 80 Hz CH 2 5K 4,0 300 Hz 80 Hz CH 1 CH 2 Dis. Notch Filter - - Enable Acq. Reject Artif. Hide Trace Stimulator Full-field Dome Flash Strength (cd/m2 2 cd/m2 Bkg. Intensity 0 Flash filter None Flash frequency (Hz) 0,1 Hz Acquisition Parameters Acquisition Time 100,00 ms Number of Events 10 Pre-adaptation (min) 0 Post Trigger (ms) 0 Discard events 3 Pre - Trigger (ms) 0 Background Intensity 0

39 PRIMUS Instruction Manual 39 Cone Response Amplifier Channel Gain Y - Magn. Low Pass High Pass CH 1 5K 2,0 300 Hz 0,3 Hz CH 2 5K 2,0 300 Hz 0,3 Hz CH 1 CH 2 Dis. Notch Filter - - Enable Acq. Reject Artif. Hide Trace Stimulator Full-field Dome Flash Strength (cds/m²) 2 Bkg. Intensity 25 Flash filter None Flash frequency (Hz) 1 Hz Acquisition Parameters Acquisition Time 204,00 ms Number of Events 3 Pre-adaptation (min) 5 Post Trigger (ms) 0 Discard events 0 Pre - Trigger (ms) 0 Background Intensity (cd/m²) 25 30Hz Flicker Amplifier Channel Gain Y - Magn. Low Pass High Pass CH 1 5K 1,0 300 Hz 0,3 Hz CH 2 5K 1,0 300 Hz 0,3 Hz CH 1 CH 2 Dis. Notch Filter - - Enable Acq. Reject Artif. Hide Trace Stimulator Full-field Dome Flash Strength (cd/m²) 2 Bkg. Intensity 25 Flash filter None Flash frequency (Hz) 30 Hz Acquisition Parameters Acquisition Time 166,00 ms Number of Events 20 Pre-adaptation (min) 1 Post Trigger (ms) 0 Discard events 3 Pre - Trigger (ms) 0 Background Intensity (cd/m²) 25

40 PRIMUS Instruction Manual 40 Pattern VEP Amplifier Channel Gain Y - Magn. Low Pass High Pass CH 1 50K 2,0 30 Hz 1 Hz CH CH 1 CH 2 Dis. Notch Filter - - Enable Acq. - Reject Artif. - Hide Trace - Stimulator Pattern Temp. Form Reverse Spatial Form. (Cpd) Checkerboard Contrast (%) 99 Temp. Freq.(Hz) 1.02 Spatial Freq (Min) 73.2 Acquisition Parameters Acquisition Time 300 Number of Events 64 Pre-adaptation (min) 0 Post Trigger (ms) 0 Discard events 0 Pre - Trigger (ms) 0 Background Intensity 0 Flash VEP Amplifier Channel Gain Y - Magn. Low Pass High Pass CH 1 50K 2,0 30 Hz 1 Hz CH CH 1 CH 2 Dis. Notch Filter - - Enable Acq. - Reject Artif. - Hide Trace - Stimulator Full-field Dome Flash Strength (cd/m²) 3 Bkg. Intensity 0 Flash filter None Flash frequency (Hz) 1 Acquisition Parameters Acquisition Time (msec) 307 Number of Events 64 Pre-adaptation (min) 0 Post Trigger (ms) 0 Discard events 0 Pre - Trigger (ms) 0 Background Intensity 0

41 PRIMUS Instruction Manual 41 Pattern Onset/Offset Amplifier Channel Gain Y - Magn. Low Pass High Pass CH 1 50K 2,0 30 Hz 1 Hz CH CH 1 CH 2 Dis. Notch Filter - - Enable Acq. - Reject Artif. - Hide Trace - Stimulator Pattern Temp. Form Appear Spatial Form. (Cpd) Checkerboard Contrast (%) 99 Temp. Freq.(Hz) 1.02 Spatial Freq (Min) 73.2 Acquisition Parameters Acquisition Time (msec) 307 Number of Events 64 Pre-adaptation (min) 0 Post Trigger (ms) 0 Discard events 0 Pre - Trigger (ms) 0 Background Intensity 0 Transient PERG Amplifier Channel Gain Y - Magn. Low Pass High Pass CH 1 5K 2,0 30 Hz 1 Hz CH 2 5K 2,0 30 Hz 1 Hz CH 1 CH 2 Dis. Notch Filter - - Enable Acq. Reject Artif. Hide Trace Stimulator Pattern Temp. Form Reverse Spatial Form. (Cpd) Checkerboard Contrast (%) 99 Temp. Freq.(Hz) 1.02 Spatial Freq (Min) 73.2 Acquisition Parameters Acquisition Time (msec) 204 Number of Events 150 Pre-adaptation (min) 0 Post Trigger (ms) 0 Discard events 0 Pre - Trigger (ms) 0 Background Intensity 0

42 PRIMUS Instruction Manual 42 Steady-State PERG Amplifier Channel Gain Y - Magn. Low Pass High Pass CH 1 50K 2,0 30 Hz 1 Hz CH 2 50K 2,0 30 Hz 1 Hz CH 1 CH 2 Dis. Notch Filter - - Enable Acq. Reject Artif. Hide Trace Stimulator Pattern Temp. Form Reverse Spatial Form. (Cpd) Checkerboard Contrast (%) 99 Temp. Freq.(Hz) 8.14 Spatial Freq (Min) 73.2 Acquisition Parameters Acquisition Time (msec) 122 Number of Events 150 Pre-adaptation (min) 0 Post Trigger (ms) 0 Discard events 0 Pre - Trigger (ms) 0 Background Intensity 0 EOG Amplifier Channel Gain Y - Magn. Low Pass High Pass CH 1 1K 2,0 300 Hz 0,3 Hz CH 2 1K 2,0 300 Hz 0,3 Hz CH 1 CH 2 Dis. Notch Filter - - Enable Acq. Reject Artif. Hide Trace Stimulator Fixation 30 Bkgfilter None Preadaptation 10 1 st. Phase 15Min 2 nd Phase 15Min

43 PRIMUS Instruction Manual 43 ENG Amplifier Channel Gain Y - Magn. Low Pass High Pass CH 1 1K 2,0 300 Hz 0,3 Hz CH 2 1K 2,0 300 Hz 0,3 Hz CH 1 CH 2 Dis. Notch Filter - - Enable Acq. Reject Artif. Hide Trace Stimulator Fixation 30

44 PRIMUS Instruction Manual 44 4 Preparation for testing 4.1 Cleaning the Skin Electrodes! Warning Be sure to disinfect the electrodes before using All electrodes should be cleaned, preferably immediately following their use. All ERG corneal electrodes, should be disinfected as described below. Before using any electrodes, if you are uncertain as to whether they were cleaned and disinfected following their previous use, repeat the procedure before using. All skin electrodes can be cleaned using warm water. A toothbrush or spiral test tube brush is helpful for cleaning the skin electrodes, particularly for removing electrode cream from the ear-clips. ( Do not use a toothbrush on contact lens electrodes.) Be sure to remove all electrode cream before it has dried, since dried cream is more difficult to remove and ist presence can impede recording. Do not soak the electrode connectors in water. 4.2 Disinfecting corneal electrodes Always disinfect electrodes following the instruction supplied from the manufacturer. 4.3 Storing elelctrodes Allow electrodes to air dry before storing. All electrodes should be stored out of direct sunlight and away from excessive heat, dust and moisture.

45 PRIMUS Instruction Manual 45 5 Preparation for Recording 5.1 Preparation for recording Flash and Flicker ERG (1) Pupillary Dilation Maximal pupillary dilation is strongly recommended for ERG recording. If dilation is less than maximal, pupil size should be noted. (2) Dark Adaptation A dark-adaptation period of at least 20 minutes is recommended. It is important that recording conditions always remain constant and identical to conditions under which normative data were collected. (3)Patient Instructions Since ERG recording is easiest to accomplish and most successful if the patient is relaxed and co-operative, it is important to gain the patient's trust and compliance. The nature of the test and the stimulus sequence should be briefly explained to the patient. Since most patients are familiar with electrocardiogram (ECG) recording, an analogy can be made between the ERG and the ECG. electrodes mast be applied to the patient following the instruction supplied from the manufacturer.

46 PRIMUS Instruction Manual 46 (4)Application of Electrodes! Caution Only electrodes which have been properly cleaned and disinfected should be used. The placement of electrodes for ERG recording is shown in Figure Ground Electrode: This is a green clip with a built-in electrode. Vigorously rub both sides of either earlobe with alcohol or abrasive lotion (commercially available for EEG and ECG recording) to remove skin oils. If the latter is used, wipe off any excess lotion with a tissue. Fill the earclip electrode with electrode cream and place on the prepared earlobe. Reference Electrode: This is a silver cup electrode. Vigorously rub a small area near each orbital rim temporally with alcohol and /or with abrasive lotion to remove skin oils. If the latter is used, wipe off any excess lotion with a tissue. Fill the central depressed area of the electrode with electrode cream and attach the electrodes near each orbital rim temporally as a reference for the corresponding eye. The electrode leads should be tacked into place with a piece of tape to keep them from falling off.

47 PRIMUS Instruction Manual 47 Active Electrodes: This is a corneal electrode it is in contact with the cornea. There are a variety of other corneal electrodes i.e. HK LOOP, Henkes, Burien Allen, DTL, Goldfoil and Carbon fibre which can be used.! Caution Before using a corneal electrode, read the "Instructions of Use" of the electrode carefully. (7)Patient Positioning The patient should be sitting down with their chin resting on the chin bar of the Full-field. Ask the patient to relax and to look towards the centre of the. Instruct the patient that they will be seeing a single flash of light. Immediately, before the flash is presented, ask the patient to refrain from blinking.

48 PRIMUS Instruction Manual Preparation for Pattern ERG (3)Patient Instructions Since Pattern ERG recording is easiest to accomplish and most successful if the patient is relaxed and co-operative, it is important to gain the patient's trust and compliance. The nature of the test and the stimulus sequence should be briefly explained to the patient. Since most patients are familiar with electrocardiogram (ECG) recording, an analogy can be made between the ERG and the ECG. electrodes mast be applied to the patient following the instruction supplied from the manufacturer. (4)Application of Electrodes! Caution Only electrodes which have been properly cleaned and disinfected should be used. The placement of electrodes for Pattern ERG recording is shown in Figure Ground Electrode: This is a green clip with a built-in electrode. Vigorously rub both sides of either earlobe with alcohol or abrasive lotion (commercially available for EEG and ECG recording) to remove skin oils. If the latter is used, wipe off any excess lotion with a tissue. Fill the earclip electrode with electrode cream and place on the prepared earlobe. Reference Electrode: This is a silver cup electrode. Vigorously rub a small area near each orbital rim temporally with alcohol and /or with abrasive lotion to remove skin oils. If the latter is used, wipe off any excess lotion with a

49 PRIMUS Instruction Manual 49 tissue. Fill the central depressed area of the electrode with electrode cream and attach the electrodes near each orbital rim temporally as a reference for the corresponding eye. The electrode leads should be tacked into place with a piece of tape to keep them from falling off. Active Electrodes: This is a corneal electrode it is in contact with the cornea or the fornix. There are a variety of other corneal electrodes i.e. HK LOOP, Henkes, Burien Allen, DTL, Goldfoil and Carbon fibre which can be used.! Caution Before using a corneal electrode, read the "Instructions of Use" of the electrode carefully. (7)Patient Positioning The patient should be sitting down with their chin resting on the chin bar of the Full-field. Ask the patient to relax and to look towards the centre of the. Instruct the patient that they will be seeing a single flash of light. Immediately, before the flash is presented, ask the patient to refrain from blinking.

50 PRIMUS Instruction Manual Preparation for VEP Recording! Caution Only electrodes which have been properly cleaned and disinfected should be used. (1) Application of Electrodes Ground and Reference Electrodes These are the two green ear clip electrodes. Vigorously rub both sides of both earlobes with alcohol and/or with abrasive lotion (commercially available for EEG and ECG recording) to remove skin oils. If the latter is used, wipe off any excess lotion with a tissue. Fill each earclip with electrode cream and place one clip on each earlobe, as shown in Figure 8 for ERG. It is unimportant which ear serves as reference and which as ground. Active Electrode: Pushing aside the hair to expose the scalp, vigorously rub the scalp with alcohol or abrasive lotion at a position approximately 1 cm above the ioion (bony ridge just above base of skull) on the midline ( designated as Oz according to the International System of electrode placement). Fill the cup of the scalp electrode with electrode cream and attach it to the scalp. Gather the leads from the three electrodes together and tape them to the patient's shoulder on the side nearest to the headrest. (2) Electrode Connections Figure... shows how to connect the electrode into the jacks of the Electrode Headbox

51 PRIMUS Instruction Manual 51 Recording Data Remove the cover of the built-in VEP Monitor located inside the Full-field. Seat the patient 24cm from the edge of the Fullfield. Once you have entered the patient data in the Primus and have checked if the impedance values are less than 5KOhms and you have covered one eye you can start with the acquisition. Ask you patient to relax and to look at the fixation target located in the middle of the VEP Monitor. Click on the start icon with the left mouse button. If the patient is cooperative, the impedance values are less than 5 KOhms and the patient is seated comfortably than there should be little or no artefacts prolonging the length of the VEP examination. Moving the eye cover from the recorded eye to the unrecorded eye. Repeat the VEP examination by clicking on the start icon with the left mouse button. After the second eye has been successfully recorded, a second trace will appear on the computer screen. Move the cursors to the point of interest (N70, P100) and check if both traces have similar latences. VEP PATTERN (ISCEV STANDARD)

52 PRIMUS Instruction Manual Preparation for EOG Recording The standardised Electro-Oculogram (EOG) is conducted with the patient's eyes dilated. The patient should not be dark adapted before the test Notes! Caution The patient should not be exposed to bright lights, such as a slit lamp or ophthalmoscope, for at least 20 minutes before the test. Only electrodes which have been properly cleaned and disinfected should be used. (1) Application of Electrodes Electrodes: The EOG uses five silver cup electrodes. Two for each eye and one for the grounding which is placed on the patients forehead. Vigorously rub a small area near the nasal and temporal canti of both eyes with alcohol and /or with abrasive lotion to remove skin oils. Make sure that you remove all skin oils, but do not get any alcohol in the patient's eye. If the latter is used, wipe off any excess lotion with a tissue. Fill the central depressed area of the electrode with electrode cream and attach the electrodes near the nasal and temporal canti. The electrode leads should be tacked into place with a piece of tape to keep them from falling off. The figure below shows the electrode set-up.

53 PRIMUS Instruction Manual 53 Recording Data Once you have entered the patient data in the Primus and have checked if the impedance values are less than 5KOhms you can start with the acquisition. The EOG collects data for the first 12Sec. of every minute. During this 12 seconds, the patient must consistently follow the EOG fixation lights. At 55 seconds into each minute, a acoustical signal will warn the patient that the EOG fixation lights will start flashing soon. Watch the patient's eye movements on the screen. Check if they are moving their eyes consistently with the lights. Encourage the patient to follow the lights. At 12 seconds into each minute, the EOG lights will stop flashing. Let the patient know that they can relax for the rest of the remaining minute. The EOG test consists of three phases: A pre-adapt phase (light on), lasting 5 minute A dark adapt phase (light off), lasting 15 minute A light adapt phase (light on), lasting 15 minute These times can easily be changed if required. Notes Make sure that the patient does not close his or her eyes during the pre-adapt or light adapt portions of the test. After the test is completed, the Arden Ratio will be automatically computed and displayed on the screen. Because the potential measured by this technique is related to many factors - including the placement of the electrodes and the geometry of the eye- the value is of little use by itself. The clinically useful value is the ration of the peak value in the light to the minimum value in the dark. This ratio is called the Arden Ratio: ArdenRatio = LightPeakValue( µ V ) DarkThroughValue( µ V )

54 PRIMUS Instruction Manual Preparation for ENG! Caution Only electrodes which have been properly cleaned and disinfected should be used. (1) Application of Electrodes Electrodes: The ENG uses five silver cup electrodes. Two for each eye and one for the grounding which is placed on the patients forehead. Vigorously rub a small area near the nasal and temporal canti of both eyes with alcohol and /or with abrasive lotion to remove skin oils. Make sure that you remove all skin oils, but do not get any alcohol in the patient's eye. If the latter is used, wipe off any excess lotion with a tissue. Fill the central depressed area of the electrode with electrode cream and attach the electrodes near the nasal and temporal canti. The electrode leads should be tacked into place with a piece of tape to keep them from falling off. The figure below shows the electrode set-up.

55 PRIMUS Instruction Manual 55 Recording Data Once you have entered the patient data in the Primus and have checked if the impedance values are less than 5KOhms you can start with the acquisition. The ENG collects data for the first 3 Sec. During this time, the patient must consistently follow the EOG fixation lights in order to perform the Calibration. Move the cursor on Traces 1 and 2 in order to fix the maximal amplitude of the trace (Peak). After that Start Acquisition informing the patient to see straight on. The spontaneous Nistagmo will be acquired. Notes Make sure that the patient does not close his or her eyes during the test.

56 PRIMUS Instruction Manual 56 6 Artefacts in Electrophysiologic Testing Artefacts in electrophysiologic testing are any electrical signal generated either by the subject, the recording equipment, or by the environment, that do not represent the subject's response to the stimulus. Artifacts can distort or obscure the evoked response to a degree that renders the recording of little or no use for diagnosis. 6.1 Artefacts Generated by the Subject Muscle Artifacts: Tense muscles can generate very significant electrical activity. For example, the ERG signal is only about 150 to 400 µv in amplitude, which is about a factor of 10 less than the electrical impulses generated by the heart. It is not surprising that significant distortion of the ERG and EOG can be produced by subjects who: Tense their jaw muscles Tense their eyelid muscles Blink Muscle artifacts of the type that interfere with the ERG and EOG produce high frequency random "noise" that rides on the baseline. The amplitude of this interference may be as high as ±50µV, which can obscure the recording. Jaw muscle noise can be particularly devastating to EOG recordings. Eye Movement Artefacts: Eye movements can produce serious errors in the ERG. They also produce EOG errors when they do not represent controlled movements in response to the alternating stimulus. There are two types of eye movement artefacts that affect the ERG. One type is unrelated to the stimulus and represents the subject's inability to fixate. The second type is due to a reflex contraction of the orbicularis muscle in response to the strobe flash. This latter artefact is called the photomyoclonic reflex (PMR) and can, sometimes, interfere with the interpretation of the b-wave. Eye movement artefacts resulting from improper fixation produce baseline shifts. The baseline may be shifted entirely off the screen or may be seen to slant up or down across the screen. Thus, the recording may be off the screen or severely distorted because of the eye movement. Ideally the baseline should appear as a horizontal line with minimal noise riding on it. If the baseline is drifting wildly, instruct the patient to carefully fixate on the red light in the sphere.

57 PRIMUS Instruction Manual 57 EEG Artefacts: For VEP recordings the principal artefact is the EEG signal. Ideally the baseline response is primarily EEG "noise". The amplitude of the EEG signal is about 50µV, while the amplitude of the VEP is about 10µV. In a single sweep recording, EEG noise completely obscures the VEP 6.2 Artefacts Generated by the Recording Equipment Baseline or Amplifier Noise: All electrical circuits generate electrical noise due to molecular activity and other non-idea aspects of signal amplification. Equipment baseline noise level can be observed by short circuiting the patient input terminals. This noise level is usually a few microvolts and is random in nature. The amplitude depends upon the characteristics of the amplifier and on the recording bandwidth (filter settings). The amplitude of this baseline noise is small and therefore does not ordinarily interfere with the evoked potential recordings. If the baseline noise is greater than a few microvolts with shorted inputs, the equipment may be malfunctioning. However, absence of typical baseline noise is generally indicative of a "dead" or saturated amplifier. If there is a complete absence of baseline noise, or excessive baseline noise, contact the Service Department. Electrode Noise: Electrical contact between the subject and recording electrodes is never perfect. The quality of the contact is termed the electrode impedance the lower this quantity is, the better. Some electrical noise will be generated by the electrode impedance. The higher the electrode impedance, the more noise is generated. In addition, the susceptibility of the patient amplifiers to electrical noise generated by the external environment increases with increasing electrode impedance. In general, the greater the electrode impedance, the greater the noise in the recording. Electrode impedance, as measured by the system, should, in general, be less than 5KOhms for low noise recordings. However, if the baseline noise level is not excessive, it is acceptable for the electrode impedance to be higher.

58 PRIMUS Instruction Manual Artefacts Generated by the External Environment 50/60 Hertz Noise: The principal external interfering signal is electrical noise generated by power lines or by electrical equipment connected to power lines. The typical electrical outlet provides a ready source of 230V electricity., more than a million times greater than the amplitude of the ERG! Examples of equipment that generate electrical interference are fluorescent light, motors (including motorised chairs), and power transformers. These items produce powerful electromagnetic fields that can induce or couple 50 Hz interference into the recordings. The closer the patient and the equipment are to these sources, the more interference will be induced into the recording equipment. The amplifiers of the system will cancel most of this interference. However, 50 Hz interference will probably be seen in the recordings if any one of these conditions exist: If the patient leads or amplifiers are close to the power lines or to electrical equipment, the electrode impedance is high, or the ground connection is poor. Therefore, care should be taken to locate the testing equipment and subject away from any major source of electrical interference and to make sure that electrode impedance are as low as possible. High Frequency Electrical Noise: Besides the power lines or equipment such as motors and transformers, electrical noise can be produced by equipment generating noise at radio frequencies. Although one might expect such signals to be filtered out by the amplifier filters, it is possible for this type of noise to generate low frequency artefacts by nonlinearities in the recording equipment and by mixing with other signals. Care should be exercised to keep the recording equipment and subject away from strong sources of radio frequency signals.

59 PRIMUS Instruction Manual Principal Artefacts and How to Limit or Minimise Them Understanding the sources of artefacts permits appropriate action to be taken to minimise the magnitude of this interference at the source. Artefacts Generated by the Subject: Muscle artifacts and eye movement artifacts that are due to improper fixation can be minimised by encouraging the subject to relax and to fixate on the Ganzfeld central fixation light. Press the oscilloscope key and observe the baseline as the subject becomes calm. When the baseline remains essentially horizontal and the random noise level appears "normal", testing may commence. The Photomyoclonic reflex (PMR) is ubiquitous, occurring to some degree in most ERGs. If it occurs early in the ERG, the PMR can obscure the entire waveform. If the PMR occurs somewhat later, on the rising portion of the b-wave, it can prevent ERG amplitude estimation. Sometimes, the PMR can mimic an ERG or can add apparent amplitude to ERG responses. Subtle PMRs can be recognised in ERG waveforms in several ways: 1) Changes in ERG waveform slope that are not consistent with the expected slope; 2) ERGs of unusual amplitude or slope; and 3) ERGs that do not replicate. Sometimes, the eye movement is preceded by stimulation of the orbicularis muscle, and the resultant spiking can be observed in the waveform. If the PMR is present, it can frequently be habituated by presenting repetitive, predictable flashes of light to the subject. Stimulating approximately once per second will properly habituate the subject's response without causing too much light adaptation. Artefacts Generated by the Environment: As mentioned above, the first step in minimising this interference is to be sure that good electrode contact has been achieved. Care should be taken to thoroughly clean the site of the electrode placement with skin cleaner. All electrode cups should be filled with an adequate amount of electrode gel or cream. If an ECG electrode is used for the reference (-) electrode, make sure that ist gel is still wet. Good ground and reference connections must be made. In ERG recordings, adding an extra drop of artificial tears to the contact lens electrode while it is in the patient's eye may reduce the electrode impedance. Any unused recording channels should be turned off. Unused channels will result in the introduction of unwanted noise. In addition, electrode leads should be as short as possible and kept away from any electrical equipment or power lines. The subject should not be near strong electromagnetic fields or close to a power line. It often helps to twist the positive and negative electrode leads to cancel signals due to magnetic induction. About one twist every two centimetres should be adequate. With these precautions, electrical noise due to primary power source equipment and radio frequency equipment will ordinarily be within acceptable limits.

60 PRIMUS Instruction Manual How to Deal with Artefacts Using System Features Muscle Artefacts: If after applying the suggestions made above, the muscle artefacts are still excessive, they may be reduced by averaging. For the ERG, averaging 10 sweeps should reduce the noise level to an acceptable level. If you are concerned about light adapting the subject from repeated flashes, setting the between sweeps to 5 seconds will minimise the problem. Although averaging is the preferred solution in most cases, muscle artefacts may also be filtered to a degree by the amplifier filters. Since musclegenerated noise is generally at the high end of the spectrum, it can be reduced in the ERG by setting the low-pass (high cut) fulter to 100 Hz rather than the usual ERG default of 500 Hz. In the standard EOG protocol, the default value of the high cut filter is 30Hz, and further filtering is not possible. Another option for dealing with muscle noise is to smooth the waveform. Smoothing the waveform results in a filtering effect (FFT) that will not alter the waveform latency. Eye Movement Artefacts: If a steady baseline cannot be obtained, the baseline may be stabilised, to a degree, by averaging. With averaging, the effects of positive and negative going eye movements are partially cancelled. Averaging 10 sweeps will generally allow a satisfactory recording to be obtained. If you are concerned about light adapting the subject from repeated flashes, setting the between sweeps to 5 seconds will minimise the problem. When employing signal averaging with automated artefact rejection, the artefact reject level should be set to eliminate those waveforms that are obviously not representative of the true response. The artefact reject criterion should be selected to be about 20% greater that the largest "true" signal expected. If too many waveforms are rejected, increase the criterion. Although averaging is the preferred solution in most cases, eye movements can also be removed by analogue filtering. Since eye movement noise effects the low frequency end of the waveform spectrum, it can be reduced by setting the high-pass (low cut) filter to 1 Hz, rather than the default of 0.3Hz for the ERG. EEG Artefacts: The primary mechanism for reducing EEG artefacts in the VER is signal averaging. Theoretically, EEG noise and other noise that is uncorrelated with the stimulus will be reduced by the square root of the number of sweeps averaged. For example, if 50 sweeps were averaged, the noise would be reduced by a factor of approximately 7. This is usually adequate to obtain satisfactory VER recordings. The use of low pass (high cut) filtering can also be helpful. The VER default filter setting is at 100Hz. The averaged waveforms will be smoother if the 30Hz filter is used. Note that the use of the 30Hz filter will add 5 to 10 ms to the latency estimate. Artefacts Generated by the Equipment: Other than taking the precautions previously discussed, there may not be much that can be done to reduce the effects of high frequency noise artefacts. It may, in fact, be difficult to recognise this form of interference since the interference is periodic and not 50 Hz, then high frequency noise should be suspected. Depending on the frequency of

61 PRIMUS Instruction Manual 61 the interference and where is originates, it may be possible to reduce it by with either the high pass or low pass filters.

62 PRIMUS Instruction Manual 62 7 Maintenance There are no serviceable parts either in the PC, Full-field nor in the connection box. Tampering with any of these components will void the warranty. 7.1 Warranty Please refer to the attached warranty agreement 7.2 Cleaning Electrodes Instructions for cleaning and disinfecting the electrodes are given in section 4.1 and 4.2 Do not clean the electrodes with organic solvent,! Caution such as thinners, which may change the colour or damage them. Do not soak the Henks, Burian Allen, in bleach or alcohol Electronic Equipment Use a damp wet cloth to clean the surface of the equipment. If necessary is difficult to remove, use diluted non-organic detergent. Clean the surface of the monitors with a soft wet cloth and diluted non-organic detergent. Notes Be careful not to allow water into the openings of the equipment. organic solvents, such as thinnners, may damage the surface of the equipment and should not be used for cleaning. Do not use a strong solvent, such as benzene, for cleaning the surface of the monitors. The glass surface may be damaged and the anti-reflective coating may peel off.

63 PRIMUS Instruction Manual Replacement of Supplies Supplies a large range of electrodes, other than the standard. If you wish to use other types of electrodes, please contact your distributor for more information. 7.4 Storage If the equipment is not to be used for a prolonged period, unplug the mains cord form the wall outlet. All electrodes should be stored in their case, after having been cleaned, disinfected and air dried. When storing the system, please follow these instructions: Do not place the system near water Place the system in a stable environment with good ventilation an d without excessive air pressure, temperature, sunshine, humidity, dust, salt or sulfur. Avoid chemicals and flammable gases. Ascertain that factors such as excessive slope, vibration and impact will not endanger the system. 7.5 Packing Materials Notes It is recommended that the cardboard boxes and packing material be kept to be used for possible future transporting of the system. If, however, the packing material is discarded, be sure to comply with local regulations for disposal.

64 PRIMUS Instruction Manual 64 8 Specifications Pentium III 700Mhz with 32MB RAM (minimum) Win 95/98/ME operating system 15" Colour VGA display 20 GB hard disk drive with 3.5" 1.4MB floppy drive (minimum) CD ROM 40X (minimum) 2 channel amplifier (4 channel optional) 12 Bit Analogue/Digital converter 9" VEP pattern stimulator integrated in the full field ERG full-field stimulator with manual filter selector in accordance with ISCEV standard specifications Automated EOG Protocol with Arden Ratio Computation Integrated impedance measurement User-friendly Windows 98 application software Data Base User-programmable settings On-screen parameter status of acquired waveforms Patient information and physician remarks stored with waveform

65 PRIMUS Instruction Manual 65 9 Optional Accessories SAT ( Scotopic Adaptation tracking) The following instructions show SAT (Scotopic Adaptation Tracking). SAT Provides to swithc P.C. Monitor in RED /BLACK colours during scotopic adaptation of the patien (Dark room). It is a usefull function wenever P.C. is located in the same room within patient. SAT will be deactivated wen not required. The pre set level of room light is adjustable depending of room light intensity by light level prest. Video board OUTPUT P.C. Monitor SAT Light sensor SAT INPUT SAT ON/OFF SAT Light Level Pre set

66 PRIMUS Instruction Manual 66 External Flash Lamp The following picture show External Flash Lamp External Flash Lamp provides patient stimulation on in supine position. It is usefull for children or to test patient under narcosys To P.C. To Ganzfeld Dome Mains Switch To Flash Lamp Ganzfel Dome / Flash Lamp

67 PRIMUS Instruction Manual 67 15, 17 or 21 Pattern Stimulator The following picture show External Pattern stimulator. When requested for special investigation or research application studies, external Pattern stimulator provide a very wide visual angle of stimulation. Available in 15, 17 or 21 Mains Swithc The following picture show the connection of Pattern stimulator to PRIMUS System To Personal Computer video Power Supply

68 PRIMUS Instruction Manual 68 LED Pattern and Goggle stimulator The following picture show LED Goggle Stimulator It is usefull for not cooperative patients or children. Goggle stimulator privide to shield the patient s eyes to room light LED Pattern and Goggle Connector

69 PRIMUS Instruction Manual 69 Additional Channel 3 / 4 setting The following instructions show how to install and setting parameter for channels 3 / 4 amplifier. In order to uptated the system with 4 channels VEP test replace the existing VEP.pre Preselection file with the new file supplied with this instructions. Rear panel connector of the full-field Personal Computer connector Connector for channels 1 / 2 electrodes box Electrodes connection Box Channel 1 / 2 Reference Ground Active

70 PRIMUS Instruction Manual 70 Personal Computer rear panel connections CH 3 / 4 Connector for electrodes box Electrodes connection Box Channel 3 / 4 Reference Ground Active

71 PRIMUS Instruction Manual 71 Amplifier Settings Click on the icon in order to open the following amplifiers setting panel. This selection is used to change the amplifier gain or filter settings for the protocol. In order to modify the amplifier settings you first have to select a channel ( ) before making any changes. These changes will not be stored unless a new preselection is stored as described above. Channel: The menu will present choices for 4 channels. If you have a 2 channel system, the settings for channnels 3 and 4 will be ignored. Amplification: There is a selection of five different gain selection available. The gain depends largely on the kind of electrode being used and on the kind of test which needs to be preformed. Y-Magnification: You can magnify or minify waveforms by setting a default value. To change the apparent amplitude of the waveform, change the value of Y-Magnif. Low Pass: There is a selection of four different filter settings. The Low Pass filter will enable frequencies to pass through which are below the selected value. High Pass: There is a selection of three different filter settings. The High Pass filter will enable frequencies to pass through which are above the selected value. Disable Notch Filter: By disabling the Notch Filter you are allowing the signal to be contaminated by 50/60 Hum noise coming from the mains power. Enable Acquisition: Needs to be selected in order to obtain a acquisition using the selected channel.

72 PRIMUS Instruction Manual 72 Reject Artefact: The Artefact Rejection, when activated, discards all the input signals exceeding the selected amplification range on the selected channel. Label: You can write a label in the relevant field in order to identify the eye in connection with the channel activated for the test. Default settings 4 Chanels Pattern VEP Amplifier Channel Gain Y - Magn. Low Pass High Pass CH 1 50K 2,0 30 Hz 1 Hz CH 2 50K 2,0 30 Hz 1 Hz CH 3 50K 2,0 30 Hz 1 Hz CH 4 50K 2,0 30 Hz 1 Hz CH 1 CH 2 Dis. Notch Filter - - Enable Acq. Reject Artif. Hide Trace CH 3 CH 4 Dis. Notch Filter - - Enable Acq. Reject Artif. Hide Trace Stimulator Pattern Temp. Form Reverse Spatial Form. (Cpd) Checkerboard Contrast (%) 99 Temp. Freq.(Hz) 1.02 Spatial Freq (Min) 73.2 Acquisition Parameters Acquisition Time 300 Number of Events 64 Pre-adaptation (min) 0 Post Trigger (ms) 0 Discard events 0 Pre - Trigger (ms) 0 Background Intensity 0

73 PRIMUS Instruction Manual 73 Preparation for VEP Recording! Caution Only electrodes which have been properly cleaned and disinfected should be used. Application of Electrodes Ground and Reference Electrodes These are the two green ear clip electrodes. Vigorously rub both sides of both earlobes with alcohol and/or with abrasive lotion (commercially available for EEG and ECG recording) to remove skin oils. If the latter is used, wipe off any excess lotion with a tissue. Fill each electrodes with electrode cream and place one site as shown in the Figure. Active Electrodes: Pushing aside the hair to expose the scalp, vigorously rub the scalp with alcohol or abrasive lotion at a position designated as Oz or O1, O2, 03, 04, according to the International System of electrode placement. Fill the cup of the scalp electrodes with electrode cream and attach it to the scalp. Gather the leads from the three electrodes together and tape them to the patient's shoulder on the side nearest to the headrest.

74 PRIMUS Instruction Manual 74 Electrode Connections Figure... shows how to connect the electrode into the jacks of the Electrode Head box Recording Data Remove the cover of the built-in VEP Monitor located inside the Full-field. Seat the patient 24cm from the edge of the Fullfield. Once you have entered the patient data in the Primus and have checked if the impedance values are less than 5KOhms and you have covered one eye you can start with the acquisition. Ask you patient to relax and to look at the fixation target located in the middle of the VEP Monitor. Click on the start icon with the left mouse button. If the patient is cooperative, the impedance values are less than 5 KOhms and the patient is seated comfortably than there should be little or no artefacts prolonging the length of the VEP examination.

75 PRIMUS Instruction Manual 75 Lifting Stand with rotation The following picture show Lifting stand with rotation Lifting Stand ensures the best comfort of the patient during the examination. Rotation is usefull for test for test patients in supine position or under narcosys.

76 PRIMUS Instruction Manual 76 Executing the Sweep VEP software Click the icon which is labelled "Sweep VEP". Sweep VEP = Visual evokted potentials to evaluate objectively patient visus Once you have selected a test Sweep VEP, the software will give you a choice of Preselection in according whith standardised ISCEV (International Society of Electrophysiology of Vision) tests. You are free to define and safe your own recording parameter. The user defined preselections can be modified and changed at any during the course of the examination. The default preselections can also be changed, but can not be stored, nor can the default setting be deleted from the list.

77 PRIMUS Instruction Manual 77 Patient New Clicking the menu 'Patient/New' or the related button in the command bar, this window is displayed. The New patient will be automatically stored into the database clicking on the 'OK' button.

78 PRIMUS Instruction Manual 78 Oscilloscope and Impedance The system will automatically enter the "Oscilloscope mode after one of the listed examinations is selected. The purpose of the "Oscilloscope Mode" (1) is to look at the incoming signals. The incoming signal should be a steady line with only a few over riding waves. If this is the case you can almost be sure that the patient is relaxed and that there are almost no muscle artefacts which are Fig 1.5 To check the Impedance between the electrodes select the button (2). The impedance display shows each electrode impedance value. The impedance values for the positive (ACT.)and negative (REF) electrodes are referenced to the common electrode (GND). 1 2 All electrode impedance should be less than 5 KOhms and be within 3KOhms of each other. Electrode impedance above 5 KOhms should be reduced. Electrode impedance that are not within 3KOhms of each other should be adjusted. When the impedance is less than 5KOhms the red dot turns to green. Fig 1.6 A reading of 100 KOhms suggests there is an open circuit. Check that the electrode is firmly attached to the skin and the lead is connected to the appropriated jack. If the impedance is still at 100KOHMs, the electrode may be faulty and should be replaced. To exit from the impedance mode press OK

79 PRIMUS Instruction Manual 79 Acquisition Mode To enter the "Acquisition Mode" move the cursor to "Acquisition" and click on the left mouse button. Before starting the examination inform your patient about your intention to start with the recording and ask them to remain calm and relaxed until the examination is completed. Move the cursor to "START" and click the left mouse button. In order to measure the latency and/or the amplitude during Acquisition click and drag with the left mouse button the square located on the yellow vertical line and move it to the area of interest. The latency and amplitude values will be displayed in the XY -box 1

80 PRIMUS Instruction Manual 80 Analysis Mode In the following all of the possible functions available in the Analysis Mode will be described. Data can be stored or retrieved in the Analysis Mode. The scale of the traces can be adjusted to fit the size of the display. Cursors mark the amplitudes and latency which are of interest to the user. In order to measure the latency and/or the amplitude at a point of interest, click and drag the cursor with the left mouse button. In order to select another trace point the cursor to the trace label and click the right mouse button. The cursors will then jump from the previously selected trace to the selected trace. In order to move the trace to another location on the screen, click and drag the trace with the right mouse button. In to the right side of the screen will be displayed the curve which describe the estimated spatial frequency seen to the patient. The field named ESF show the exactly value of estimated spatial frequency.

81 PRIMUS Instruction Manual 81 Save Acquired Data The Sweep VEP program will automatically prompt whether or not you wish to store the acquired data before going to the next examination category. To store the acquired data from within a examination select File from the task bar and select Save Acquired Data. Display storied traces on Screen If you wish to view further traces of this particular patient, click the READ FROM DISK button and a list of examinations will be shown on the screen again. In the examination list you will find a list of all examination done on the selected patient. Select the examination you want to view and click LOAD button. The software will then automatically be started and the trace will be selected.

82 PRIMUS Instruction Manual 82 Setting your own parameters Before you can set your own parameter you have to make adjustments in the following tables. After selecting the required parameters for the Amplifier, Acquisition Parameters and for the Stimulator save the setting using Save Preselection. Amplifier Acquisition Parameters Stimulators

83 PRIMUS Instruction Manual 83 Amplifier Settings This selection is used to change the amplifier gain or filter settings for the protocol. In order to modify the amplifier settings you first have to select a channel before making any changes. These changes will not be stored unless a new preselection is stored as described above. Channel: The menu will present choices for channels. Amplification: There is a selection of five different gain selection available. The gain depends largely on the kind of electrode being used and on the kind of test which needs to be performed. Y-Magnification: You can magnify or minify waveforms by setting a default value. To change the apparent amplitude of the waveform, change the value of Y-Magnif. Low Pass: There is a selection of four different filter settings. The Low Pass filter will enable frequencies to pass through which are below the selected value. High Pass: There is a selection of three different filter settings. The High Pass filter will enable frequencies to pass through which are above the selected value. Disable Notch Filter: By disabling the Notch Filter you are allowing the signal to be contaminated by 50/60 Hum noise coming from the mains power. Enable Acquisition: Needs to be selected in order to obtain a acquisition using the selected channel. Reject Artefact: The Artefact Rejection, when activated, discards all the input signals exceeding the selected amplification range on the selected channel. Hide Trace: Label:

84 PRIMUS Instruction Manual 84 Stimulator settings The parameters for Pattern can be set according to the user's specification by selecting the stimulators and specifying the parameter. Acquisition Parameter The Number of Events is the number of traces to be averaged in order to obtain the final curve. The curves discarded by means of the artifact rejection are not included in the averaged result.