3CPM EGGSAS User Manual
Contents
1. 23CPM COMPANY The 3CPM Company Electrogastrogram Broaden your scope oj diagnoses in today s world oj gastrointestinal disorders Research Version Electrogastrogram Version 2 08 OPERATION MANUAL AND USER GUIDE THE ELECTROGASTROGRAM RESEARCH VERSION 7402 York Road Phone 410 494 1846 Suite 100 Fax 410 494 1726 Towson Maryland 21204 Mark Noar 3CPMCompany com I 2 3 4 5 3CPM EGGSAS Research User Manual letus oe NOE ANG OEI dT Q 3 IAS A EN 4 2 1 Human Interface Mod le uis b ai 5 ZA1 Human Interface Module Indicator Light oooocncnnncccnnnnnnoccnnnnnnnnnnnonancncnnnnnnnos 6 2 1 2 When indicator Lise Is Flashing o2 cites nd Dott een Ecoute ie aate cotes ias 7 Preparation tor TS COTCHDO eo ao 7 3 1 PS 7 3 2 JPrepanne the Pates 8 PrOSramiCDeEOELOD iio 9 4 1 Starine the PO ed 9 Recordine a diablo 10 5 1 Selectine a Pallars 10 Dele RESME 3 5 iu nated MED ML M D CU T MOM M d LIT Ga 11 5 3 Enteime Patient Demostra p MeS ti id 17 25 4 JPrecstudysInfODITIAbO oso eio uite elt Id da A 13 5 5 Eguipment Tetra a a iia 14 5 5 1 Equipment Test Falur Er aia ida 15 30 Baselme Records ati csi 16 2 4 Post Baseline ODpUOHnS oscine Pneu Poeta aed a Pedo aed rt bu n 17 5 8 Postt inuladon Records cid 18 39 Recording Events Durnin SUY oeren a ns 19 24107 pd Ope e aa a E T E E TOE 20 S101 iAmalyzme Base ne Perdi ia 21 5 10 2 Analyzing Pos2. Printer M ame hp deskjet S550 series Properties Status Ready Type hp deskjet 5550 series Where LUSBOO1 Comment Paper Orientation Size Letter 3 5 11 in Portrait SOLUCE Auto A Landscape Help Network Lancel Select Printer 10 Patient Information The following patient information items require that a patient study has been read into the program or that a new study has just been completed 38 10 1Demographics Patient demographics can be edited by selecting Edit from the top menu and then selecting Patient demographics The patient demographics screen below is displayed Patient Demographics Patient name First Hame E Last Mame IM oo Date of Birth EE mmddyy Social Security Number NEM Address NEN Address City D State Zip Code NEM Fhone number NEM Hospital number e Research reference number Cancel Figure Edit Patient Demographics When you have entered and or changed the desired items click OK to have the system accept the changes and close the screen Cancel closes the screen and discards all changes You may also view the patient demographics by selecting View from the top menu and then selecting Patient demographics The patient demographics screen above is displayed You cannot change anything 39 10 2 Medications Patient medications can be edited by selecting Edit from the top menu and then s
3. i 3 Frequency CPM Tia 06 04 2008 The full screen RSA graph can be viewed using one of the following methods e Select the RSA icon 4 from the top of the screen e Selecting Analyze from the top menu and then select RSA 34 The graph is also included in the second page of the report if included in the report see Configuring Reports 9 Reports Reports are only available after the entire study has been analyzed The default or standard report consists of 2 pages organized as follows e Page Facility information at top of page Patient information Patient name Date of study Attending physician Referring physician Technician Indications Stimulation medium Diagnosis Recommendations o Signature and date e Page 2 RSA e Page 3 plus required additional pages Raw data graphs of the selected minutes One graph per period O O O O O OOOO 9 1 Configuring Reports can be configured to include exclude the following items e Patient information RSA Data Sheet Raw data graphs of the selected minutes One graph per period Graphs of the entire raw signal starting on the next available page until all graphs are printed e Event log 35 Configure the graphs by selecting Report from the top menu and then selecting Configure Report The following screen 1s displayed Configure report IF the core repart iz de selected you can then select the items to be in the report x Patient Informa
4. NO 44 A A E E 45 13 C losiie the PrO TI een id 4 14 EGGSAS Research Version Menu OVEVIE Wii li 48 I The Ele Mens E YE 48 I NN IS shrsitet devs rovteuat a a nuarcnaeee 48 14 1 2 NeW Late iii ti dan 48 JESUS e NEN 48 Id Open Pror MU a o i EL tat ed 48 AMES Save SERERE TITO pad 48 AO gt RESUME S BUG ac euce diete ocio 48 1d L7 Backup Or R69SLOFO ue AAA ede Peut ob AT 49 E MEE c e atsat ec are Ses se r uesthas hacerlo arsp nas ao N 49 AES APTN Eey O sedo ticdu uod LM det Ped Mind 49 14 1 10 Dime a a 49 14 1 11 Reca NS 49 14 1 12 A EE 49 A A ettet dni ea nr ene acum nn meen aerate nee wen UE 49 AM E duri ipe T EE 50 E SS SEEK Wi 1G diis a 50 EN The Goto Medline 50 I4 5 The Analyze Mem usd tT Sanabria bus 50 14 5 1 Prior To Setting Baseline and Post Procedure Time esses 51 14 5 2 After Baseline and All Periods are Set ccccccccnnonnncncnnnnnnnnnnnnononnncnnnnnnnnnnannnccnnnnnos 51 110 The Reports Mei A 51 Ido E rena T RH cd Ete 51 Ido PRIBURG DOLI dutusne ica a a amie amapage esu TE ded ut 52 14 0 5 Cr ate Spreadsheet of Data 5Be6 iie dread bM Eheu E Rea edoS 22 LO Connlegure RE DORE rmac 22 t463 Faculty practice TfOPHIatfODGs odores deos Deest iod uei nieto aer dec fair decem 52 3CPM EGGSAS Research User Manual 1 Introduction and Overview The 3CPM Company s Electrogastrogram EGG Machine is an EGG analysis system that records stores displays an
5. Set Good Minutes check box This same procedure is used for selecting the period length and the good minutes to analyze for any more post stimulation periods you wish to add 22 5 10 2 1 Creating Periods The program automatically creates one period after the baseline At this point the period Post Stimulation Period 1 is not set as an actual period capable of analysis It is simply the record of the entire post stimulation period The rules for creating each period are e The previous period must have been created by selecting the start and end minute for that period and from those minutes a start and end minute must be selected from the minutes in that specific period e There must be at least 4 minutes available for analysis between the current period and the previous period or baseline e The current period must be analyzed e There cannot be more than 46 periods including the baseline e A period cannot be inserted before the baseline The act of creating a period by setting the length and good minutes creates the next period automatically That next period will contain all the remaining minutes of the recording 5 10 2 2 Deleting a period The program measures reactions over linear time Therefore you can not delete a period You may reassign the minutes to create fewer periods where the minutes are distributed differently The most effective way to accomplish this 1s to use the Reset Periods button allowing you t
6. below the initial study Once a study 1s selected this option takes you straight to the baseline page skipping the data entry screens 14 1 5 Save Patient When not grayed out it allows you to save the present study 14 1 6 Resume Study This allows you to resume a study that you had previously paused 48 14 1 7 Backup or Restore This takes you to the screen that allows you to backup a database and all studies to a new location It also allows you to restore the backed up database 14 1 8 Print This does the same thing the Print Icon does which is to bring up the printer selection box and allow you to print the report NOTE The report must be displayed to print 14 1 9 Print Preview This option takes you to the Report for reviewing prior to printing 14 1 10 Print Setup Allows you to pre select a printer to use for the report 14 1 11 Recent Files This is a future enhancement to the program and is therefore grayed out 14 1 12 Exit Exit and close the program 14 2 The Edit Menu This and all remaining menu choices apply to a study that File Satie View Goto Analyze Report F l has already been opened in the program Edit options are E Patient demographics for making changes in the study information Most options m Patient diagnostic History take you to the section defined so you can make changes to Patient Medications the data Pre Study Information Respiration Stimulation med
7. interruption in drug therapy is appropriate The following practical points will help to ensure a quality EGG recording Record the EGG in a quiet room with subdued light Avoid all loud noises or distracting voices Position the patient in a comfortable chair or recliner Instruct the subject to keep arms and legs still and to avoid in particular any quick body movements 5 Talking should be avoided during the recording oe uod am 3 2 Preparing the Patient l Prepare to position the EGG electrodes as shown a The RED EGG lead wire and electrode 1s positioned in the mid clavicular line left side approximately two inches below the left costochondral margin b The BLACK EGG lead wire and electrode 1s positioned at the mid point between the xiphoid and umbilicus c The GREEN EGG lead wire and A electrode 1s positioned in the mid T clavicular line on the right side two inches below the right costochondral margin The GREEN EGG lead is the reference or ground electrode ey Preparing the skin a Shave off abdominal hair that 1s present in these locations for electrodes 1 2 and 3 b Gently abrade the skin in the areas of these electrode positions using a Buff Puff or a coarse cloth Positioning the electrodes on the skin a Connect the color coded EGG lead wires to the Human Interface Module by matching the lead wire color to the corresponding color coded plug in as designated on the Modul
8. scenario in the list or selecting it and then selecting the Recall button A What If scenario is deleted by selecting the item in the list and then selecting the Delete button If the currently viewed scenario is deleted and the user just selects the Close button to go back to the main display the original study is displayed the What If description is no longer displayed 33 7 3 Saving What If Scenarios and Studies The data for a What If scenario and the study data are treated differently when saved If a What If scenario is loaded the Save toolbar button lil will save only the data items in the What If data see the list above Any other items that have been changed will not be saved at this time Example If a user changes the good minutes in a given period in the currently loaded What If scenario and also changes the diagnosis and selects the Save toolbar button lad only the data for the What If scenario will be saved The diagnosis will not be saved Then the user opens the What If window and will be prompted to save the patient data 1 e the diagnosis Each time the What If window is opened the program checks for any unsaved data in both the What If scenario and the study If either or both have unsaved data the user will be prompted to save the data 8 RSA The RSA is a graph of the spectral estimates of the EGG signals in 4 minute epochs lu ko A A H 6s DX me F TK i Stimulation medium phase ELLE L H
9. to stop the study You will be asked 1f you are sure you want to cancel the study 5 8 Post Stimulation Recording Select Begin Study from the screen shown below to start recording the signals study phase Begin Study Figure Study Phase This lasts for up to 3 hours The count down clock in the upper left corner of the screen shows the time remaining in the study period If you select Cancel 1t will stop the study without saving the data and all information will be lost When you are finished with the study select Finished to complete the study The following screen is displayed While this screen 1s displayed the study will continue Finish the Study Figure Finish Study If you have checked Finish the Study and selected OK the study will stop If you have not checked Finish the Study or selected Cancel the study will continue 18 5 9 Recording Events During Study Events are such things as coughing movement nausea etc Events can be marked during both the baseline and post stimulation periods To mark an event move the mouse cursor over the desired place on the EGG trace the cursor will change shape to a pointer finger and click the left mouse button The following screen is displayed Record Event Cough Pain Ingestion Talking Movement Vomiting Nausea Other Description Cancel Figure Event Recorder Check the event or events that occurred You may also enter a des
10. atient and or the study are not saved The selected study 1s not displayed You may also view the patient medications by selecting View from the top menu and then selecting Patient Medications The patient medications screen above is displayed except that you cannot select Update Medication and you will not be able to change a medication From this screen you may only select a study and go to 1t This is done in the same manner as described above 10 3 Diagnostic History Diagnostic history can be edited by selecting Edit from the top menu and then selecting Patient diagnostic History The patient diagnostic history screen below is displayed Diagnostic History 2 1 3 2004 Post prandial EGG ts suggestive of Probable T achygastria Date Diagnosis NETT OF Cancel Figure Diagnostic History 41 You select a diagnosis by selecting the Date of study 1 e clicking on the Date of study Once you select a date of study the selected date 1s displayed in the Date field and the diagnosis 1s displayed in the Diagnosis field and Go to study is enabled The diagnosis cannot be changed here You must go to the study to change the diagnosis You can go to the selected study in one of two ways e Select the study from the list and then select Go to study e Double click on the Date of study in the list If you have selected a different study than what 1s currently selected and made changes to the current patient information or
11. ce number box is checked only the Research reference number will print on reports Once the demographics have been entered click on Continue to continue with the study If you don t want to enter all the demographics at this time they may be entered later see the section on patient demographics 12 Cancel stops the study without saving any information Save and Close saves the patient demographics and ends the study The patient won t be available if you try to select a patient study as there is no study yet However if at a later date you start a study again with this patient the program allows you to use the previously entered patient demographics When Continue is selected you may then enter pre study information 5 4 Pre study Information Pre study information is entered through the following screen Pre study information Time of pre test meal 23 AM Indication for procedure Nausea GERD Post prandial fullness Vomiting Eructus Bloating Early satiety Additional Indications Attending physician Referring physician Technician mes Ho Figure Pre study Information The time of the pre test meal is entered as follows e Highlight the hours and either click on the up and down arrows to change the hours or type in the hours If you use the up and down arrows the AM PM will automatically change when appropriate e Press the Right Arrow key to highlight the minutes and eit
12. cription in the Description box Select OK to record the event or Cancel to cancel the event Events are displayed as a blue line along the axis of the graph of the data for the time period they are recorded in Depending on the reason for the event these markers can help with the selection of good minutes during analysis During the recording of an event the system 1s still recording the signal 19 5 10 Study Completed Once the study is complete it is generally a good idea to save it immediately To save the study click on the icon for saving a file E You can also select File from the top menu and then select Save Patient When the study 1s complete the raw EGG and respiration signals are displayed for the baseline period Any events that have been marked are also displayed lit dic esearch Version uita d opas Pie Edi Wen Goto Analyse Faperk Heip D gb HEt H a poorer YU ao 40 180 110 iln Es Diete Mirada For help pra Ft Figure Main Screen Data Signal Events may also be added at this time Follow the same procedure as in recording events during the study Events 20 5 10 1 Analyzing Baseline Period mmm eraio aua Goths Min Edi Wem Gota Anaon Papert Heip O a B Matt poem YU oo ao ido i 130 Ea abes Por help pra PL The length of the baseline period is fixed Select the start and end of the good minutes by setting the Start minute and End minute and then check S
13. d prints the myoelectric signals from the stomach as an aid to diagnosis of various gastric motility disorders Optimum use of this device requires a basic familiarity with the published literature which describes typical EGG patterns commonly encountered in clinical practice with specific patient groups and related interpretative techniques An appendix is provided at the end of this manual however which illustrates the data and printed displays produced by this device The setting up of the equipment is described in the section on equipment setup The filter characteristics of the amplifier allow those biological signals with approximate frequency ranges from 1 to 15 cycles per minute cpm to pass through for recording and digitization Two channels of data are recorded during the session One of these 1s the EGG signal itself the other channel records respiratory rates This respiratory recording channel is used to help identify artifact in the EGG signal caused by movement deep breathing etc The analog signals recorded from the EGG skin electrodes and the respiratory belt are amplified filtered and fed into four cables The cables are connected to a computer which has been equipped with an analog to digital A D converter for digitization of the EGG signal The data file that 1s created during the A D conversion of the EGG signal undergoes Fourier transform FT an analysis of the frequencies contained in the EGG signal and a running spec
14. displays a window that allows you to change the pre study information in the same manner as mentioned in the section on Pre study Information 6 5 Stimulation medium Select Edit from the top menu and then select Stimulation medium and quantity This displays a window that allows you to change the stimulation medium in the same manner as mentioned in the section on Stimulation Medium 6 6 Change number of minutes per graph The number of minutes as they are viewed per graph 1s initially set to 4 minutes This may be changed by selecting View from the top menu and then selecting Change number of minutes per graph The following window is displayed Change minutes per graph Change the number of minutes that are displayed on each graph E Figure Change number of minutes per graph Enter the number of minutes you want to see displayed on each graph and then select OK to save the number of minutes per graph The graphs will change according to the number of minute entered za 7 What If Scenario Option This option allows the user to perform reanalysis of a prior analyzed study while keeping the original study data analysis intact There 1s no limit to the number of What If analyses that can be performed based on an original study You can also use the F symbol The original study must be analyzed and saved before the What If window is available The data in a What If scenario is as follows Period start minutes Period l
15. e label b Attach the pre jelled electrodes to the snap on ends of the EGG lead wires c Remove the plastic covers from the adhesive side of the electrode and place on the skin according to the instructions in 1 above Positioning and connecting the belt for recording respiration rate e With the subject in a sitting position attach the belt across the upper chest with belt placed under the arm pits and the entire belt pulled snugly Recording of EGG and respiratory signals e Once the EGG and respiratory signals are stable the baseline preprandial EGG recording period can begin 4 Program Operation The 3CPM EGGSAS program allows you to perform the following operations e Record a new study for either a new patient or open a prior study e Analyze the study to arrive at a diagnosis e Create and print reports for a study 4 1 Starting the Program The program may be started in one of 2 ways EGG e Double click on the desktop icon for the 3CPM EGGSAS program SA5 e Select the Start button then All Programs select 3CPM Company and then 3CPM EGGSAS Once the program is started the main screen is displayed HN Research Version 3CPM EGGSAS File Edit View Goto Analyze Report Help y q Ne For Help press F1 Figure Opening Screen 5 Recording a Study The program guides the user through the entire EGG recording process The EGG recording process follows the steps listed below in the order listed 5 1 Se
16. een Select from the first section of menu items to go to the specified period Also note that if the period has been analyzed there is a check mark next to the menu item This is an easy way of telling if a period has been analyzed e Use the dropdown list next to the patient name and date of study Select the dropdown list and then select the period to go to that period e Use the Goto icons at the top of the screen just below the menu items Uses the icons as follows Iq This displays the baseline period This displays the previous period This has no effect if the baseline period 1s being displayed This displays the current period This is useful if viewing the report or RSA and you wish to go back and look at the period you were previously viewing This displays the next period This has no effect if the last post stimulation period is being displayed d This displays the last post stimulation period 43 12 Backing Up and Restoring Data You can backup or restore your data by selecting File from the top menu and then selecting Backup or Restore The following screen is displayed Backup Restore Data Figure Backup Restore Data 12 1 Backup Select Backup A standard Microsoft Windows Save as screen is displayed The File name is 3CPM EGGSAS MDB The file name must not change Navigate to the directory including Network directories or drive where you want to backup the data to and select Save For exam
17. electing Patient Medications The patient medications screen below is displayed Medications Date of study 2 13 2004 i Date Medication Update Medication Lo to study Figure Edit Medications You can select a medication by selecting the Date of study 1 e clicking on the Date of study Once you select a date of study the selected date is displayed in the Date field and the medication is displayed in the Medication field The medication can be changed by typing in any changes in the Medication field and then selecting Update Medication You can go to the selected study in one of two ways e Select the study from the list and then select Go to Study e Double click on the Date of study in the list If you have selected a different study than what is currently selected and made changes to the current patient information or study and have not saved them the warning screen shown in figure Warning Save Patient is displayed 40 If you have selected a different study than what 1s currently selected and made changes to the current patient What If scenario and have not saved them the warning screen shown in figure Warning Save What If is displayed You have the following choices e Yes Save the changes to the patient and or the study and then display the selected study e No The changes to the patient and or the study are discarded and then the selected study is displayed e Cancel The changes to the p
18. electing a Patient for a study is displayed that allows you to select the patient whose study 1s to be resumed This screen only shows those patients whose study has been paused see Baseline Recording e Once you select a patient you will automatically be positioned to start the study see Post stimulation Recording 11 5 3 Entering Patient Demographics Patient demographics are entered through the following screen Patient Demographics Patient name First Name Last Name Date of Birth mm ddr yyy Social Security Number Address Address City State ip Code Phone number Hospital number Research reference number Gave and Close Cancel Help Figure Patient Demographics In order to Continue the study either a patient s first and last name or a research reference number is needed To enter a name just type the first and last names in the appropriate field To enter a research reference number click on box to the left of the Research reference number This enables the field to the right and places the cursor in that field so that it 1s ready to accept keyboard input Then type in the number NOTE If you use a reference number the program views it as a blind study and will blank out the patient s name The name is still saved in the database but will not be visible until the check box next to the Research reference number 1s unchecked again Any time that the Research referen
19. endations and select OK to cause the program to accept the recommendations 5 10 5 Respiration Rate You can either enter the respiratory rates or modify them using this screen You can display the screen using the following method Respiration Post stimulation period 1 Post stimulation period 2 Post stimulation period 3 Change Respiration Help Figure Edit Respiration Rate e Select Edit from the top menu and then select Respiration 28 Select the period in the list by clicking the left button of the mouse Then enter the respiration rate in the Change Respiration field Finally to record the respiration rate select the Set Respiration button Select OK to cause the system to accept the rates 6 Opening a Prior Study To select a prior study first display a list of patients and their studies by using one of the following 2 methods e Select the icon to open an existing file a e Select File from the top menu and then select Open Prior Study If there is currently a study open and you attempt to open another existing study and have made changes to the current patient information or study and have not saved them the following warning screen is displayed Warning You have made changes to this patient and didn t save them Do you want to save them Figure Warning Save Patient You have the following choices e Yes Save the changes to the patient and or the study and then display the list of pat
20. engths Selected good minutes Respiration rates 7 1 No Prior What If Scenarios The What If window is displayed as follows if there are no prior What If scenarios What If Scenario Description NEW Figure What If Scenario No What If scenarios The NEW item is automatically selected Enter a description in the Description field The choice NEW or Original study is not allowed as What If descriptions 23 After the description 1s entered select the Save button to save 1t After saving the What If scenario the Recall button becomes enabled Then select either Close or Recall button to go back to the main display The description 1s displayed above the graphs and to the right of the period dropdown list 7 2 What If Scenarios The What If window is displayed as follows if there are What If scenarios for a study What If Scenario 2008 02 08 14 598 NEW 2007 07 13 Original stud 2008 02 08 14 56 eri Description Save Recall Delete Close Help Figure What If Scenario with What If scenarios The list is ordered by descending date and time 1 e the most recent date and time 1s at the top of the list The NEW and Original study listings are always displayed first in the list The What If scenario that is currently being viewed on the main display is automatically selected Now the Recall and Delete buttons are enabled A What If scenario 1s loaded by either double clicking on the
21. et Good Minutes check box Now you can go to the post baseline period which 1s after the patient ingested the stimulation medium You can do this by using one of the 4 following methods Select the go to next period icon at the top of the screen Select Goto from the top menu and then select Next period Select the Analyze from the top menu and then select Post stimulation period 1 While in this menu item if you have completed analyzing the baseline period you will notice that there is a check mark next to the Baseline period menu item This indicates that the baseline period has been analyzed Open the pull down list at the top of the screen and select Post stimulation period 1 221 5 10 2 Analyzing Post stimulation Periods The post stimulations periods are displayed as follows and eh Feria PA AnS Fia Edi tas Lene eb D a tl H 4 BH gos YN Po reip prex Fl Select the length of the initial period for analysis by setting the Start minute and End minute Notice that prior to selecting the initial period the first post stimulation period includes all the minutes of the study When you select the length of the period the remaining minutes after the last minute in the period create the second post stimulation period Check the Set Period Length check box to set the length of the period Select the good minutes within the period just created by setting the Start minute and End minute and then check
22. he proper periods you wanted 6 1 3 Changing Events The events for the current period may be changed using the Events area in the lower right corner of the screen Select an event from the list The description 1s displayed below it Select Edit to change the event You may change the event in the same manner as mentioned in the section on Events You cannot change the time of the event Select Delete to delete the event The following warning is displayed Warning Are you sure you want to delete this Event 44 33 0 Select Yes to delete the event and No to if you don t want to delete the event 6 1 4 Adding Events New event may be added in the same manner as described during recording a study see Events 6 2 Changing the Diagnosis Select Edit from the top menu and then select Suggested diagnosis This displays a window that allows you to change the diagnosis in the same manner as mentioned in the section on Diagnosis If you have previously entered a diagnosis you may also change it by selecting Edit from the top menu and then selecting Suggested diagnosis 30 6 3 Changing the Recommendation Select Edit from the top menu and then select Recommendations This displays a window that allows you to change the recommendations in the same manner as mentioned in the section on Recommendations 6 4 Changing the Pre study Information Select Edit from the top menu and then select Pre Study Information This
23. her click on the up and down arrows to change the minutes or type in the minutes e Press the Right Arrow key to highlight the AM PM and either click on the up and down arrows to change the AM PM or type in the AM PM 13 Select any of the Indication for procedure items that apply and or enter any Additional Indications Enter the Attending physician the Referring physician and the Technician actually performing the study This screen does not have to be filled in now It may be filled in later by selecting Edit from the top menu then selecting Pre study Information Select Cancel to stop the study When you select Begin Study the screen for running the equipment test is displayed 5 5 Equipment Test This section of the study makes sure that the signals EGG and Respiration are stable Both signals must be stable for 2 minutes The initial screen shown below shows the Respiratory sensor and Gastric electrodes in large red dots When these turn green the system 1s ready to start the baseline The EGG signal shown in red is in the top graph The Respiration signal shown in black is in the bottom graph To start the equipment test select the Start Equipment Test button When both the Respiratory sensor and the Gastric electrodes turn green the Begin Baseline button gets enabled Then to start the Baseline select this button Equipment Test Micro Volts g o gt E Start Equipment Test Respiratory senso
24. ients and studies e No The changes to the patient and or the study are discarded and then the list of patients and studies are displayed e Cancel The changes to the patient and or the study are not saved and the list of patients and studies 1s not displayed The program keeps the current patient and study 2 96 If the current study which you are working on is a What If scenario and you attempt to open another existing study and have made changes to the current What If scenario see What If and have not saved them the following warning screen 1s displayed Warning You have made changes to What If scenario and didn t save them Do you want to save them Figure Warning Save What If You have the following choices e Yes save the changes to the What If scenario and then display the list of patients and studies e No The changes to the What If scenario are discarded and then the list of patients and studies are displayed e Cancel The changes to the What If scenario are not saved and the list of patients and studies is not displayed The program keeps the current patient and study The list of patients and the studies performed on them is displayed in the following screen Select Patient Current database of patients Patient name Date of stud FEE tee 06 1 32008 MEversionz 06132008 lest 06022008 110 06 04 2008 test 06092008 test change OF 4 2008 ted 0302008 old 08702 2008 Select patie
25. ium and quantity suggested diagnosis The Edit options take you to the screen noted by the Option This is true for all but the What If option Recommendations what IF 49 14 2 1 What If The What If option opens a screen that allows you to run multiple analyses on a single study See the What If section of the manual 14 3 The View Menu ttt ffff Research Version 3CPM EGGSAS File Edit SVE Goto Analyze Report Help Ge Baseline period Post stimulation period 1 ttt FEFE Patient demographics This is a navigation menu allowing you to move Patient diagnostic History through each aspect of the current study Patient Medications Pre Study Information Respiration Stimulation medium and quantity Suggested diagnosis Recommendations RSA Data Sheet Events Change number of minutes per graph 14 4 The Goto Menu GG zac ttt fiff Research Version 3C File Edit View ex Analvze Report 1 m Y A Start of study Previous period ttt FEE Current period Mex period End of study This 1s also a navigation menu allowing you to move quickly to parts of the current study data 14 5 The Analyze Menu This menu shows the current status of what part of the study 1s available for analysis 50 14 5 1 Prior To Setting Baseline and Post Procedure Time ttt tfit Research Version 3CPM EGGSAS File Edit View Goto Ww Report Help GE q4 Baseli
26. lecting a Patient Your may choose to record a study for a new patient or record another study for an existing patient You may elect to start a study for a new patient in one of two ways e Select the icon for a new file LI from the toolbar just under the top menu e Select File from the top menu then select New Study and then select New Patient 4 Research Version 3CPM EGGSAS File Edit View Goto Analyze Report Help Mew study Ctrlt h Mew patient Open prior study Cbrl 0 Existing patient Resume Study Backup or Restore Print Setup Exit You may elect to start a new study for an existing patient as follows e Select File from the top menu then select New Study and then select Existing Patient 10 e Then a screen is displayed that allows you to select the patient for the study Select Patient Current databaze of patients atlent name Select patient database Cancel Help Figure Select Patient for Stud y You select the patient in one of two ways e Double click on the patient name e Single click on the patient name and then select OK Cancel stops the study Once you have started a study the demographics screen is displayed allowing you to enter or change the patient demographics 5 2 Resuming a Study You may resume a study that has been previously paused as follows e Select File from the top menu then selecting Resume Study e Then the same screen used in S
27. m reanalysis 1f you would like to preserve the original analysis 6 1 2 Change a Post Stimulation Period A post stimulation period is displayed as shown in the following screen lt cesen He Edit ee Goto hiyi beoi Hei D El H 4 Bh H g prr PR sa Demie re dem mr jn CETA T For reip praf Figure Main Screen Re Analyze Post Stimulation Period Notice that the period length and good minutes are already selected These are the period length and minutes that were selected when the study was previously analyzed You may change the period length by changing either the Start minute or End minute Notice that the Set Period Length becomes unchecked You must check it again to accept the new period length Also notice that the Set Good Minutes has become unchecked See Analyzing Post stimulation Periods for additional information You may change the selected minutes by changing either the Start minute or End minute Notice that the Set Good Minutes becomes unchecked You must check it again to accept the new good minutes See Analyzing Base Period 29 WARNING Changing the post stimulation periods or minutes will erase all prior selected minutes or subsequent post stimulation periods if the newly selected periods or minutes are saved The What If scenario option should be used to perform reanalysis 1f you would like to preserve the original analysis information Use the Reset Periods Button and then set t
28. ne Press Yes to stop the baseline No to continue the baseline If you select Cancel it will stop the study lt 16 5 7 Post Baseline Options At the end of the baseline there are 3 options l Select Pause Study to pause the study The following warning screen is displayed Select Yes to pause the study and No to continue with the study It can then be resumed later Resuming a Study a This feature is only used in the event that following the baseline recording it is necessary to pause the study in order to allow for patient repositioning Warning Are you sure you want to pause the study Press Yes to pause the study No to continue the baseline Select Resume from the File menu to resume the study 2 Select Skip Stimulation Medium if there will be no stimulation medium given to the patient prior to beginning the study The program will take you immediately to Post stimulation Recording where you may begin the study 3 Select Stimulation Medium to give the patient some stimulation During this part of the study the patient ingests some stimulation medium When the patient 1s finished enter the description of the stimulation medium the quantity and units in the screen shown below Stimulation Medium Ingest Stimulation Medium Description Iw oz Quantity 0 ml grams cae Help Figure Stimulation Medium Select Start study to begin recording the signals 17 Select Cancel
29. ne period d i L e The Analyze Menu starts with the last two options Post stimulation period 1 ttt FEFE grayed out This is because the menu is dependant Current period on your setting the baseline and period s length and good time As you set each a check mark appears beside it in the menu E ok 7 V IA f 14 5 2 After Baseline and All Periods are Set ttt tfft Research Version 3CPM EGGSAS File Edit View Goto Ww Report Help 14 w Baseline period w Post stimulation period 1 Once all the periods are set for analysis and the checkmarks are visible you can input your ttt FEFE Current period diagnosis Also once the periods are set the Diagnosis analysis engine 1s able to create the RSA for the RSA study 5 ENS T y 14 6 The Reports Menu This menu allows you to view the report generated by the analysis data selected and includes supporting analysis data ttt ffff Research Version 3CPM EGGSAS File Edit View Goto Analvze Weiz Help O a W d 4 WO o ie report 14 6 1 View Report This choice generates the report and presents it on the screen in the format it will print ttt Ffff Create Spreadsheet of Data Sheet Configure Report 100 Facility practice information eee 51 14 6 2 Print Report The Print Report option brings up the printer selection screen for printing the report 14 6 3 Create Spreadsheet of Data Sheet This selection will exp
30. nt database lt MES Cancel Help Figure Select Patient Open Prior Study 27 You will notice that the Select Patient Screen now contains both the prior studies and any what 1f scenarios which are those studies under the main study that are indented and preceded by a dash If research reference numbers are being used the reference number replaces the patient name Select a patient and a study in one of the following 2 methods e Double click on the patient name not the date of study e Single click on the patient name and then click OK 6 1 Re analyzing the Study 6 1 1 Changing the Baseline The first screen displayed after selecting a patient and study is the raw signals in the baseline period POE dl Aerea Merlo JA d ek D a El II A poer Y MU birer 102 s 8 Lnd Decor i 108 EE BD 40 18 0 11 0 130 Por help pra Fi Figure Main Screen Re Analyze Baseline Notice that the good minutes are already selected These are the minutes that were selected when the study was previously analyzed 28 You may change the selected minutes by changing either the Start minute or End minute Notice that the Set Good Minutes becomes unchecked You must check it again to accept the new good minutes See Analyzing Base Period WARNING Changing the baseline minutes will erase all selected minutes or subsequent post stimulation periods The What If scenario option should be used to perfor
31. o start over However it is possible to reassign period and good minute lengths using the Set Minutes toolbox on the right NOTE If you had an initial reason to set periods and then discovered that a different set of periods may lead to a different conclusion using the What If option 1s the recommended method 5 10 3 Diagnosis Once all the periods baseline and post stimulation periods have been analyzed you may enter your own diagnosis In this Research Version the program will only allow free text entry of a diagnosis You can display the Diagnosis screen by using one of the following methods e Select the recommendation icon from the top of the screen e Select Edit from the top menu and then select Diagnosis 23 The following screen 1s displayed Diagnosis M Suggested diagnosis Diagnosis IT ype diagnosis here Cancel Help Figure Diagnosis When you are finished writing a diagnosis select OK to cause the program to accept the diagnosis 5 10 4 Recommendations Once a diagnosis has been entered you will be able to enter recommendations You can display the recommendation screen by using one of the following methods e Select the recommendation icon P from the top of the screen e Select Edit from the top menu and then select Recommendations 24 The following screen 1s displayed Patient recommendations Cancel Help Figure Patient Recommendations Enter your recomm
32. ort the data in the data sheet that is used in the report into a Comma Separated Value csv file that can be opened by most spreadsheets This allows the collection of report data in spreadsheet form in one workbook for multiple studies 14 6 4 Configure Report This option brings up the report configuration screen 14 6 5 Faculty practice information This brings up the screen to enter information on your faculty practice NOTES 52
33. ple your data is on the C drive and you select D drive the CD drive to backup up your data to Once you select Save from the standard Microsoft Windows Save as screen the above screen 1s changed to Backup Restore Data Restore Backup to Start File being copied Help Figure Backup Data 44 Select Start to start the backup During the backup the file being copied is displayed under File being copied Also the field next to the text Backup displays the progress of the backup If the backup has completed successfully the following screen is displayed FGGSAS Figure Backup Complete Select OK Then select Close from the above screen If the backup fails an appropriate error message is displayed indicating what may be wrong The following is a list of possible errors e There is no destination disk in the selected drive e The destination disk is full e The file already exists This message is only displayed once If you elect to overwrite the first file then all additional files are overwritten e There is an error writing to the directory disk This may occur for a number of reasons If you are writing to a CD try another CD the CD may be damaged Ifyou are writing to a directory either on the local PC or on the network make sure you have permission to write 12 2 Restore To restore data from a backup exit the program restart the program and select File from the top menu and
34. program Attaching the connectors to the patient and attaching the USB cable to the computer will not turn this light on Starting a study does not immediately turn this light on Only after you select the Begin Study button at the bottom of the Pre Study Information box does the indicator light appear 00 men PTA MY A NN pr teeta Indicator Light On Begin Test 2 1 2 When Indicator Light Is Flashing Once the recording of a study is ended and you have selected Finish the light will begin to flash notifying you that it is no longer collecting data It will remain flashing until disconnected However if you choose to move directly to a new study you can ignore the flashing light and it will turn to a solid light as soon as you select Begin Study on the Pre Study Information box Also because it 1s a USB device it can be unplugged and plugged back in between studies with the program open 3 Preparation for Recording 3 1 General The subject should consume 4 ounces of apple juice and one piece of dry toast two hours prior to the start of the EGG recording session The subject must then fast for the two hours immediately preceding the session If consistent with patient well being drugs which produce myoelectrical or contractile activity e g narcotics prokinetic agents should be discontinued for 48 hours prior to the recording The patient s own physician must determine whether this
35. r D Gastric electrodes Select Cancel to stop the study 14 5 5 1 Equipment Test Failure Error After a given period of time 1f the signals do not stabilize you will see the following warning Equipment Test The signal is NOT stabilizing Select one of the Following To contin e in manual mode select Ok To cancel the test select Cancel Cancel Minutes start Equipment Test Respiratory sensor eo Begin baseline Gastric electrodes Y C rcel Help Signal Not Stabilized If you select to continue in manual mode it 1s likely that you will not be able to analyze the data It is recommended that you cancel the test check the proper attachment of connections both to the device and the patient then restart the test 245 5 6 Baseline Recording Select the Start Baseline button see screen below to start the baseline part of the study The baseline may last for up to 1 hour Once there are enough minutes to analyze 4 minutes the baseline may be stopped The count down clock in the upper left corner of the screen shows the time remaining in the baseline period Baseline Volts Micra Figure Baseline When you select Stop Baseline to stop the baseline the following warning is displayed Select Yes to stop the baseline and No to continue with the baseline The baseline will continue to be recorded until either Yes or No 1s selected Warning Are you sure you want to stop the baseli
36. splayed You have the following choices e Yes Save the changes to the patient and or the study or the What If scenario and then close the program e No The changes to the patient and or the study or the What If scenario are discarded and then the program is closed e Cancel The changes are not saved and the program 1s not closed 47 14 EGGSAS Research Version Menu Overview This is a step by step overview of each menu item in the menu bar and their related submenus This written to give a basic understanding of what each choice does Why and when to use each is defined throughout the users manual 14 1 The File Menu The best way to look at what choices you will find here is that each choice made is a choice related to an entire study 14 1 1 New Study Start a new study It gives you two choices 4 Research Version 3CPM EGGSAS mim Edit View Goto Analyze Report Help 14 1 2 New Patient Starts with the last opened database and brings up the Patient Demographics screen to start collecting study information Mew study ieee Mew patient Open prior study Cbrl 0 Existing patient Resume Study Backup or Restore 14 1 3 Existing Patient This option brings up the Select Patient screen in vie the last opened database Print Setup 14 1 4 Open Prior Study EE This also brings up the Select Patient Screen but you will now see any What If scenarios for the patient as choices that are indented
37. study and have not saved them the warning screen shown in figure Warning Save Patient is displayed If you have selected a different study than what 1s currently selected and made changes to the current patient What If scenario and have not saved them the warning screen shown in figure Warning Save What If is displayed You have the following choices e Yes Save the changes to the patient and or the study and then display the selected study e No The changes to the patient and or the study are discarded and then the selected study is displayed e Cancel The changes to the patient and or the study are not saved The selected study 1s not displayed You may also view the diagnostic history by selecting View from the top menu and then selecting Patient diagnostic History The patient diagnostic history screen above is displayed The same operations are available as described above 42 11 Navigating the Baseline and Post Stimulation Periods Navigating between the baseline period and the post stimulation periods can be accomplished in several ways e Use the View menu at the top of the screen Select from the first section of menu items to go to the specified period e Use the Goto menu at the top of the screen Select from the menu items to go to the start of the study baseline the previous period the current period the next period or the end of the study last period e Use the Analyze menu at the top of the scr
38. t stimulation PerlodS oocccccccccnonooncncnnnnnnnonnnnonncncnnnnnnnonannnnnnnnnnos 22 AS CNET S TM 23 DLA RECOMMEND e 24 3410 57 Respraton e isa 25 Peni ne a Pror Study P 26 6 1 Resanal Zine OSU o obs 28 6 1 1 Chans mie the Basel a 28 6 1 2 Chan se a Post Sumilao Period neresini a A N 29 6 1 3 Chane me EYES a S uan ua deste uu v teo e ee aan 30 6 1 4 ZA CONDI BAS EMS emet ae ettet Msn ott od mote ade s pter 30 6 2 Chanoine the Dia eNO sis ceo aca sain eU onec bu a 30 6 3 Chanemo the Recommendation qot eu topped E a etes 3l 6 4 Changing the Pre study Information esee eene nnn 3l 6 5 Suma ton medi iret hdc Noctua o E errr s ede irit 3l 6 6 Change number or minutes per a ende eoi t dem la Rx bb 3l What I Sceno Boite eee aaa 32 7 1 INO Prior What IT SCETELIOS usada 32 Ju O A ita beu atesu dada E E 33 7 3 Saving What H Scenarios and SUIGICS ca ox ou A A cue nai a Lal Erud 34 Rida utate 34 II S a E Eie LEE 35 9 1 ANA O E E T 35 9 2 A die tomo uec ids ed ave Go oU ul Dodd ae cU UN Ld adt 37 9 3 MS A E Utd tnde bend DE 37 10 Patient Tint Oma a oi leia 38 POLL DEMOSTAPNIOS ai AAA AAA AAA AAA E 39 t02 INNS VC ATG ud inicia 40 T0 Diaso te MSN visites exe oce id 4 11 Navigating the Baseline and Post Stimulation Perl0dS ooccccccccnnnoncnnnnnnnnnnnnnnnnnnnnnnnnnnos 43 12 Backine Up a d Restore Data 44 124 e A
39. then select Backup or Restore IMPORTANT NOTE Restoring data will only work if it is the first action performed after starting the program The initial Backup Restore data screen is displayed Figure Backup Restore Data Select Restore A standard Microsoft Windows Open screen is displayed The File name is 3CPM EGGSAS MDB The file name must not change Navigate to the directory including Network directories or drive where you have the backup data you want to restore and select Open 45 For example your backup data 1s on the D drive in the directory EGGSAS data 13 14 Feb 04 Once you select Open from the standard Microsoft Windows Open screen the screen shown in Figure Backup Restore Data is changed to Backup Restore Data Restore from Database 13 FEB 04 Start File being copied R estore Help Figure Restore Data Select Start to start the restore During the restore the file being copied is displayed under File being copied Also the field next to the text Restore displays the progress of the restore If you are restoring over an existing database you will get the following message BACKUP ERROR ES The file c 3cpm 3CPM EGGSAS mdb already exists Do you want to overwrite it Figure Overwrite If you want to overwrite the existing database and data files select Yes and the restore operation will continue If you don t want to over
40. tion amp RSA Data sheet rJ Haw Signal of Selected Minutes E E Event lag Lancel Help Configure Report Select the items you want included in the report or de select the items that you want removed from the report Select OK to put the items in the report Select Cancel to leave the report unchanged 36 9 2 Facility Information Facility information can be entered at any time Select Report from the top menu and then select Facility practice information The following screen is displayed Facility Information Facility Practice name Address Address A City state Zip Code Phone number carcel e Figure Facility Information Enter the information and select Save and close to save the information in the database Cancel discards any newly entered information and leaves the facility information unchanged in the database The information initially entered will appear at the top of all reports unless edited 9 3 View Printing Once the study has been analyzed the report can be viewed by selecting Report from the top menu and then selecting View report While the report is being viewed it can be printed Print the report using one of the two following methods e Select the print icon from the top menu e Select Report from the top menu and then select Print report 37 Either of these methods displays a standard Windows Print screen Print Setup
41. tral analysis RSA A plot of the RSA and calculation of the percentage of power in selected frequency bands are reports produced by the EGG analysis system These EGG data are presented in four major frequency ranges e normal 2 5 to 3 75 cpm e bradygastria 1 0 2 5 cpm e tachygastria 3 75 10 0 cpm e duodenal respiratory 10 0 15 cpm The data in these ranges are described in four ways the raw power log uv the percentage distribution of the power in the specific ranges described above the ratio of power based on postprandial to preprandial power the RSA of the EGG recording presented in a pseudo 3 D format pe ecc As will be explained in more detail in the following sections the basic technique for recording an electrogastrogram involves the following steps 1 Proper placement of electrodes and adjustment of equipment 2 Management of the patient in a subdued environment so as to minimize movement or other artifact causing events 3 Recording of up to a one hour baseline preprandial period 4 Administration of a stimulation medium test in which the patient drinks or ingests a stimulation medium as per individual protocol 5 Completion of the session by recording up to an additional 3 hours of data following the ingestion of the stimulation medium postprandial period 2 Equipment Setup The Human Interface Device is powered by the USB connection to the computer Refer to the diagram and follow the instr
42. uctions below USB CONNECTOR Connecting the Human Interface Module to the Computer RESPIRATION BELT 1 Connect the respiration belt to the Human Interface Module at the location marked Resp 2 Connect each of the EGG lead wires to the Human Interface Module according to the color of the lead wire and the port plug in color designated on the label a a Red to red green to green and black to black 3 Connect the larger U shaped end of the USB Cable to the plug in on the end of the Human Interface Module marked USB 4 Connect the other end of the USB Cable to the computer USB 2 0 ports will read faster than the older ports The system may give you this warning when you connect It does not mean the module will not work NOTE USB cable must be no longer than six feet in length 2 1 Human Interface Module The Human Interface Module is the small device that interfaces the signals from the patient to the EGGSAS software Eo NTERFAC MODULE Version 1 01 The MCPM Company This 1s an example of the Human Interface Device when properly connected The ICEFM AS 7403 Verb Hoad Sie POM Bialriamaarw Ary land 21204 4 143 4 9d 1716 As EPM Compan cnm Connected Device 2 1 1 Human Interface Module Indicator Light The module has an indicator light on the same side as the connections for the leads This light displays that the device is being accessed by the
43. write the existing database and data files select No and the restore will stop 46 If the restore completes successfully the following screen is displayed EGGSAS Figure Restore Complete Select OK Then select Close from the above screen Figure Restore Data If the restore fails an appropriate error message 1s displayed indicating what may be wrong The following is a list of possible errors e There is no source disk in the selected drive e The destination disk is full e The file already exists This message is only displayed once If you elect to overwrite the first file then all additional files are overwritten e There is an error writing to the directory disk This may occur for a number of reasons If you are writing to a directory either on the local PC or on the network make sure you have permission to write If you have performed any other action with the program close the program and restart it 13 Closing the Program The program can be closed in the following ways e Click on the X in the upper right corner of the main program screen e Select File from the top menu and then select Exit If you made changes to the current patient information or study and have not saved them the warning screen shown in figure Warning Save Patient is displayed If you made changes to the current patient What If scenario and have not saved them the warning screen shown in figure Warning Save What If is di
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