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3CPM EGGSAS User Manual
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1. SCPM The 3CPM Company Electrogastrogram Broaden your scope oj diagnoses in today s world oj gastrointestinal disorders Research amp Waterload Version Electrogastrogram Suite 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 3CPM EGGSAS Research Waterload User Manual L 3n oducuon and VEEVIO W decocto resur tud em etude dotem ce eden Aeterna dU Eus 3 2 EQuipriedit 56D Di iessonctertanidniecdi E ipte ME sin duod oit REOR ene meron ne 4 2 1 Human Interrace Modil a ueioeittastes shut etien te tne N 3 2 1 1 Human Interface Module Indicator Light eseeeeeeeeeeeeeeeeeee 6 21 2 Wrhrendngi carer Light lS Flas MNE assises nb en rti Or vh TERI 7 2 2 Gc TL 7 5 Preparation Tor Recordin aus o pierre ete tub be pe aee ate but ule tu diuque tub seva doe epe luu abu divide 7 3 1 Preparine the Patents uos e o duci e pen dst Sat bucina vitem ur did ote Satu tentum atus e quM 8 d PEOST Opera 0 0 Meee eer pore Reet eer eee Ree ey Mare MNES re en UTE RAT PIC Toe eee eee 9 3 Choosing the Version Durno Statup 40 99 ot adm t abd noise econ iut d ea eben 9 5 1 Starts The CPEOSTOUWE etate cti terea ut etos E 9 5 2 Selecting a Patient to Choose Which Version cccccccssssseeeecceeeeeaeeesseeeeeeeeeeaaaeenees 10
2. Configure report E IF the core repart is de selected vou can then select the items to be in the repart x Patient Information M RSA Data sheet r m Iv Haw Signal of Selected Minutes E E Event log Cancel Help Configure Report 35 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 12 2Facility 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 Pe City state ZipCode Phone number caret Heb 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 12 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 t
3. 2 Minutes Micro Volts Micro Volts A Aa ho A com S en Minutes Micro Volts A A N amp 8 9 10 11 12 Minutes For Help press F1 Figure Main Screen Data Signal 52 18 8 1 Analyzing Baseline Period To accept the program selected good minutes click on Accept This completes the analysis for the baseline period Now you can go to the next 10 minute period which is the first 10 minutes after the patient ingested water You can do this by using one of the 4 following methods e Select the go to next period icon at the top of the screen e Select Goto from the top menu and then select Next 10 minute period e Select the Analyze from the top menu and then select First post water 10 minute period 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 e Open the pull down list at the top of the screen and select First 10 minute period 18 8 1 1 Manually selecting minutes to analyze You may manually select minutes to analyze good minutes by rejecting the program selected good minutes Click on Reject to reject the program selected minutes The above screen is changed to the following screen 8 V F 3CPM EGGSAS File Edit View Goto Analyze Report Help D gw IM 4 B DI RSA 9 NM VF 02 13 2004 Baseline v Artifact start mi
4. preserve the original analysis information Use the Reset Periods Button and then set the proper periods you wanted 29 9 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 is 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 4435 0 Select Yes to delete the event and No to 1f you don t want to delete the event 9 1 4 Adding Events New event may be added in the same manner as described during recording a study see Events 9 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 9 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 30 9 4 Changing the Pr
5. DEMO aPN RR TTE ETE 37 15 2 Medications see aie OR ME iun v e Mt etudu mie Re Ruin tait E 38 15 9 Dias nosu TIISUOLY aisi eode doro ied OE odo end a 39 14 Navigating the Baseline and Post Stimulation Periods eeeesseeeeseees 4 15 backme Up and Restoring Dal osse i obs b Udo dpud pu Dena e sauk EVO Und spa Agua o vadam bs 42 ISL SCID 0 42 IMMENSE 43 16 C lost TC PEOSTAOB ocecornispu motn MS NR NUR NAT anto cob MCHN CL oDMai Mal eet oS RR 45 17 USING THE WATERLOAD VERSION eere nennen 46 18 IRE COEGING a Std eese eas ewes ater etudes Odone Sp MUTO ananectal ewe keene Dude 46 SL 3 elecuns d Patients detected o envoi Re op Don aie nuseuswudeosus pupa MEO UD En EN vns Toe o ada Rata ub SEE 46 15 2 JEnterme Patient DemoSsrdpli S ouorsedtbincestotc da bte based ea P ka Mete tpe ct ia adeb uuu Se P EAR EU aras 47 18 3 Pre Study Information saris E E tabi 48 A Egupmon esteen a ec oem odo ved ata cut E dui et tantu 49 15 5 Baseline ROCOFOUIDE 12S xexeH dote decer een coded ducati NEL cott S 50 O EVV UCD VA ee tP tr PS 50 15 7 OSU ANGE IS CC OFGIHO 0 2 oiii eset ao cao eat causa ane ite esca tu ee Dah aaabe cae Ou E oce e p Out 51 l1o 9 Sudy C OPHDIOICU coucou raped Eutr taten reefers edt a Pe Nene I uU E LIEGE 22 tset Analy zine Daselme Per OC i eoe een ER e eun etn EUER ued Van Rue euet du 53 I5 9 2 Analyzing Post water Periods oc eet Ret oue deua t UEM duele ee tee a ERU 54 1883 AIA COS E
6. 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 Research Version 3CPM EGGSAS mim Edit View Goto Analyze Report Help Mew study Ctrl h Mew patient Open prior study Cbrl 0 Existing patient Resume Study Backup or Restore Frink 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 11 e Then a screen is displayed that allows you to select the patient for the study Select Patent Current database of patients atent name Select patent database Cancel Help Figure Select Patient for Study 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 8 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 Selecting a Patient for a study 1s
7. 54 5 5 4 RecommiieldatlofiSss ees eiu dotate uae otia n cite hes elt aon cibos dase sion pg vectetee Ub ck be awe 55 t803 3ROSDIFQUOD Re esa r ean 55 19 Selecting an Existing Study iot eta e a edet et rane Ebor ete ub eod et rue bus 56 ION Resanalyzing TC bU oon inet timeo aodio de qaot o aea cdit URd dao e du 57 19 2 hanpino the Da CMO SIS o ssec dint apad Bod oct td leud aide tesa Medo diris 58 19 5 Canes the IRecommenddatiOTbsn eb con edv eee E aene aa 58 19 4 Changing the Pre study InfortmatlODs etie hte tu ep ear ns ot eoa ae aunt e es ete etre uet 58 195 Amount of Water IiPeSILeQ niic eter o Mte Ela EAQUE ttai ed qae e ed o PN dedos 58 20 liz eL A 58 2 R 10 eT Lm 58 Zieh COLUNN 4 eetesitadi En dob o ec RUM a SONT A alec dat at eva eo Od ter AdEe du feud 50 21 2 Pacthty IMTOLMAM OM is sees sioe rye heb ere so E bred en TAE 60 21 5 NINOS aescmeuuiio dva a aue metu b tdm tu ned ora IM I DNE dU 60 22 Patent TntokmoltiOT osea E ance nya Vt cacti Cose dos UM carne BodL UA 60 22h DEMO rap Suena monii a te sa tonos qu atta ott ee eH 61 22 2 NVC CUCL OMS irae eect ee Selene wees aS eee ec See eee 62 D2 MEME Diono UIC TAS OY RET 63 23 Navigating the Baseline and Post water Periods cccccccccceccesseeseeeeeeeeeeeaeeeeeeceeeeeeaaas 64 24 Backing Up and Restoring Data ccccccccssssssseecceececeaeessseecceeeeeeaaassseecceeeessaaaeseseeeeess 65 25 Close SIS POS IOT
8. 6 xSelectine WICE V CLS Oen a a a a den tenu e dads 10 7 USING THE RESEARCH VERSION i ite e sina 11 S RECORGING aSU Veera a O E 11 8 1 SClECTING a Patle b c sessi oett sated tad rro tub Stil meant du peti ua dedun tanbnutindatamsnetaibaatalondedentaies 11 S2 Remin a S ea a a ews etc M CUTE ate ee omens 12 8 3 E tenne Patient De mosrapDWieS ssec E 13 St JrossnidsvIntorrmatiOfi eeen A E a 14 8 5 Eguipment Tes anse a a N ud totam Sum o toma 15 8 5 1 Equipment Test Falur ETO naron a EA 16 5 0 Basehne Recordin E A es 16 8 7 Post Baseline Options 255i tot ee e a a a a Vet bu on 17 8 8 Posttiinuladon Recordin Seedsin 19 8 9 Recording Events D ttne Study oido dinde ion 20 550 39 BUG 02 OMNI Ce Osteo bans E same ub conttoai A red uut edu out PIC 20 Std Analyzing Baseline Periods eere etn duod Pec be esaet Mace sd bets a oca 21 8 10 2 Analyzing Post stimulation Periods ccccccccccccccsseeseeeceeeeceeaeesseeeeeeeeeeaaeeeeees 22 5 109 3DIGOTIOSIS exeusmesisdtet ueste matu qdisdbins thoes ld usin t pat eda diis M och bend estes aeui dunls 24 SOA JR comtmeHddllOllsen stes tet tens tette totae etai toutou bis iota euis 24 5 10 5 ARCSDIPAWMON Rate uodetesio d MMC ibadtb m deb pata te UMOR tai bad ide tenuate 25 PME O Sire ec duode E 26 9 Ise analyzino tlie SUDO oie index beast dete m a o DM Lei id 28 9 1 1 Cha nembp the Base me monia obw an aaa eaabneda E o Dou dd c 28 9 1 2 Chan se a P
9. 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 13 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 8 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 i Attending physician Referring physician Technician mes neo 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 either click on the up and down arr
10. 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 is 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 toit This is done in the same manner as described above 13 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 271372004 Post prandial EGG iz suggestive of Probable T achygastria Date Diagnosis Figure Diagnostic History 39 You select a diagnosis by selecting the Date of study i 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 sele
11. You cannot change anything 13 2 Medications Patient medications can be edited by selecting Edit from the top menu and then selecting Patient Medications The patient medications screen below is displayed Medications Date of study 2 13 2004 Date Medication Update Medication ao to study Figure Edit Medications You can select a medication by selecting the Date of study i 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 38 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 If you have selected a different study than what is 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
12. displayed that allows you to select the patient whose study is 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 12 8 3 Entering Patient Demographics Patient demographics are entered through the following screen Patient Demographics Patient name First Name Last Mame Date of Birth mm ddr vy Social Security Humber 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 reference number box is checked only the
13. have the following choices e Yes Save the changes to the patient and or the study and then display the list of patients 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 is not displayed The program keeps the current patient and study 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 is displayed Warning You have made changes to What If scenario and didn t save them Do you want to save them Cancel Figure Warning Save What If 2 96 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 FEE tee O61 3 2008 NE version 0
14. number Save and close Cancel 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 This information appears at the top of all reports 21 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 amp from the top menu e Select Report from the top menu and then select Print report Either of these methods displays a standard Windows Print screen 22 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 60 22 1 Demographics 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 Mame M Last Name F Date of Birth mmidd Social Security Number Address Address City PO State ZipCode Fhone number NEN Hospital number Research reference number tae Figure Edit Patient Demographics When you have entered and or changed the
15. 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 spectral 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 pole 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 th
16. 2 Restore To restore data from a backup exit the program restart the program and select File from the top menu and 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 43 For example your backup data is 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 e 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 e The file c 3cpm 3CPM EGGSAS mdb already exists Do you want to overwrite it Figure Overwrite If you want to overwrite the existing datab
17. 6 13 2008 test 06 02 2008 110 06 04 2008 test 0er 09 2008 test change OF 42008 ted OF 30 2008 old 06 02 2008 Select patient database Lese Figure Select Patient Open Prior Study You will notice that the Select Patient Screen now contains both the prior studies and any what if 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 27 9 1 Re analyzing the Study 9 1 1 Changing the Baseline The first screen displayed after selecting a patient and study is the raw signals in the baseline period ELTE ICI Ed Wee Goto Anaon Bipot Hep D a B M4NS HRS poer Y MU mn Emera o ku m Liis ra Sun Mala Tcr iip pres 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 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 s
18. ER IRR m 65 3CPM EGGSAS Research Waterload User Manual 1 Introduction and Overview The 3CPM Company s Electrogastrogram EGG Machine is an EGG analysis system that records stores displays and 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 eroups 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 is 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
19. Pl The length of the baseline period is fixed 221 Select the start and end of the good minutes by setting the Start minute and End minute and then check Set 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 e Select the go to next period icon at the top of the screen e Select Goto from the top menu and then select Next period e Select the Analyze from the top menu and then select Post stimulation period I 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 e Open the pull down list at the top of the screen and select Post stimulation period 1 8 10 2 Analyzing Post stimulation Periods The post stimulations periods are displayed as follows For rein pre F 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 22 Select the good minutes wit
20. am suggest a diagnosis and then you may accept it or enter your own diagnosis You may have the program suggest a diagnosis by following one of the 2 methods below e Select the suggested diagnosis icon P from the top of the screen e Select Analyze from the top menu and then select Diagnosis The following screen is displayed Diagnosis Suggested diagnosis Post prandial EGG is suggestive of T achygastna f Accept Modify Reject Diagnosis Cancel Figure Diagnosis 54 If you select Accept you accept the program s suggested diagnosis If you select Modify the suggested diagnosis is copied to the Diagnosis area for you to modify If you select Reject the Diagnosis area is left blank for you to enter your diagnosis When you are finished one of the above actions select OK to cause the program to accept the diagnosis 18 8 4 Recommendations Once a diagnosis has been accepted using the above procedure 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 from the top of the screen e Select Edit from the top menu and then select Recommendations The following screen is displayed Patient recommendations Cancel Figure Patient Recommendations Enter your recommendations and select OK to cause the program to accept the recommendations 18 8 5 Respiration Rate You can either enter the res
21. ase and data files select Yes and the restore operation will continue If you don t want to overwrite the existing database and data files select No and the restore will stop 44 If the restore completes successfully the following screen is displayed FGGSAS Figure Restore Complete Select OK Then select Close from the above screen Figure Restore Data If the restore fails an appropriate error message is 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 16 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
22. atient 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 46 Once you have started a study the demographics screen 1s displayed allowing you to enter or change the patient demographics 18 2Entering Patient Demographics Patient demographics are entered through the following screen Patient Demographics Patient name First Mame Last Name Date of Birth mm dd Social Security Number Address Address City State ip Code Phone number Hospital number Research reference number Save and Close Cancel Figure Patient Demographics In order to Continue the study either a patient first and last name is needed 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 of it and places the cursor in that field so that it is ready to accept keyboard input Then type in the number 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 Cancel stops the study without saving any information 47 Save and Close saves the patient demographics and e
23. ccurred You may also enter a description 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 8 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 filelgl You can also select File from the top menu and then select Save Patient 20 When the study is complete the raw EGG and respiration signals are displayed for the baseline period Any events that have been marked are also displayed m if Im eee not rum iii mI pe t 1s Dm oo H4 NOM Ea r YT m Eme 2 wa eh APA PAT MK ss T nl TIE V edu V UA Mn TR NU M een HE p diare f a Enimie Gy al A Sel Good birer Oo a 10 0 big 13 Borrin Per hep pmi Fi 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 8 10 1 Analyzing Baseline Period Lit IET tenir tr Ferri JNa Gow Edt Wem Gaa Analyon Fapert Help Da M4 HEMbHro5 jj wen TYMP na Ease whe teed oo ao 10 0 ILE 126 Ea Dee Brais T Pas Help prema
24. cted a different study than what 1s 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 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 is 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 40 14 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 curr
25. 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 61 22 2Medications Patient medications can be edited by selecting Edit from the top menu and then selecting Patient Medications The patient medications screen below is displayed Medications Date of study 2 1 3 2004 si Date Medication Update Medication Go to study Figure Edit Medications You select a medication by selecting the Date of study i 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 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 the 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 study and have not saved them the warning screen shown in figure Warning Save Patient is displayed You have the following choices e Yes Save the changes
26. dy The list of patients and the studies performed on them is displayed in the following screen Select Patient Curent database of patients Date of study 2 13 2004 02 13 2004 02 13 2004 02 13 2004 02 13 2004 02 13 2004 02 13 2004 02 14 2004 02 14 2004 Select patient database Figure Select Patient 86 If research reference numbers are being used the reference number replaces the patient name If the user has set up alternate databases of patients use Select patient database to select an alternate database and list the patients and studies in that database 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 19 1 Re analyzing the Study The first screen displayed after selecting a patient and study is the raw signals in the baseline period 8 C 7 3CPM EGGSAS SAS File Edit View Goto Analyze Report Help Dame MW NH M RoR ox nx RP Cz 02 14 2004 Baseline M Artifact start minute end minute 0 5 1 0 Micro Volts E d KS ce Am oU Good minutes 41 91 Accept C Reject Micro Volts NM CO CO non OO D Volts C2 Cn e M N Cn e Micro Volts E 2M e ec QUO UO Volts C2 94 e M Nh Cn e Micro Volts a i RS ce ec og co Minutes For Help press F1 Figure Main Screen Re Analyze Notice that the
27. e 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 instructions 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 is an example of the Human Interface Device when properly connected The JCP AMID E ampan Fang Virk Hoad Sie POM Bialriamaarw Stary lal 21204 4 143 4 9d 17 X5 kepa EPM Compan cnm Con
28. e first section of menu items to go to the specified period If the study as an extra 10 minute post water period there will be an additional menu item for the fourth 10 minute post water 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 If the study as an extra 10 minute post water period there will be an item in the list for the fourth 10 minute post water period 64 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 4 This displays the previous period This has no effect if the baseline period is 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 post water period This has no effect if the last post water period is being displayed d This displays the last post water period 24 Backing Up and Restoring Data REFER TO SAME THE SECTION IN THE ABOVE RESEARCH VERSION MANUAL 25 Closing the Program REFER TO SAME THE SECTION IN THE ABOVE RESEARCH VERSION MANUAL NOTES 65
29. e study Information Select Edit from the top menu and then select Pre Study Information This 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 9 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 9 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 Cancel 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 10 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 is no limit to the number of What If analyses that can be performed based on an original study You can also use the symbol The original study must be analyzed and saved before the Wha
30. elected minutes or subsequent post stimulation periods The What If scenario option should be used to perform reanalysis if you would like to preserve the original analysis 28 9 1 2 Change a Post Stimulation Period A post stimulation period is displayed as shown in the following screen EmENEMEEENEEEDHEDE He Feat ee Gs nace Pepsi Heb Du E S H34N Hm jg mr TM dr Tf Mr rhe For Pein prse FI 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 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 if you would like to
31. ent period the next period or the end of the study last period e Use the Analyze menu at the top of the screen 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 lq This displays the baseline period 4 This displays the previous period This has no effect if the baseline period 1s being displayed Hi 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 d This displays the next period This has no effect 1f the last post stimulation period is being displayed d This displays the last post stimulation period 41 15 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 15 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
32. f 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 Module 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 pre prandial 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 5 Choosing the Version During Startup You must start the program before selecting a version 5 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 e Select the Start button then All Programs select 3CPM Company and then 3CPM EGGSAS O
33. good minutes are already selected and Accept is already selected These are the minutes that were selected when the study was previously analyzed You may change the selected minutes by selecting Reject and changing the minutes in the same manner as previously described see Analyzing Base Period IMPORTANT NOTE If you change the selected minutes in the baseline period you must re analyze all the remaining periods 57 19 2 Changing the Diagnosis You may 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 19 3 Changing the Hecommendation You may change the recommendations in the same manner as mentioned in the section on Recommendations 19 4 Changing the Pre study Information You may change the pre study information in the same manner as mentioned in the section on Pre study Information 19 5 Amount of Water Ingested You may change the amount of water ingested in the same manner as mentioned in the section on Water Load 20 RSA The RSA is a graph of the spectral estimates of the EGG signals in 4 minute epochs The full screen RSA graph can be viewed using one of the following methods e Select the RSA icon P fl from the top of the screen e Selecting Analyze from the top menu and then select RSA The graph on a much smaller scale is also inc
34. he top menu and then select Print report SG Either of these methods displays a standard Windows Print screen Print Setup Printer Name hp deskjet 5550 series X Properties Status Ready Type hp deskjet 5550 series Where X LUSBOO1 Comment Paper M Onentation Size Letter 8 5 M 11 in f Portrait Source t D Landscape Help Network Select Printer 13 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 13 1 Demographics 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 Name QO Last Name Mo Date of Birth as mm dd yyyy Social Security Number ny Address C Address o City CE State Zip Code o Phone number ans Hospital number Research reference number Cancel Figure Edit Patient Demographics 37 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
35. hin the period just created by setting the Start minute and End minute and then check 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 8 10 2 1 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 8 10 2 1 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 effec
36. ian 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 18 4 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 is 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 gt E z Start Equipment Test Respiratory sensor e Gastric electrades D Figure Equipment Test Select Cancel to stop the study 49 18 5 Baseline Recording Select the Start Baseline button see screen below to start the baseline part of the study This lasts for 10 minutes The count down clock in the upper left corner of the screen shows the time remaining in the baseline period At the end of the ten m
37. inutes there are 2 options e Select Extend baseline for 10 minutes This continues the baseline for another 10 minutes At the end of this extra 10 minutes you select Water Load e Select Water Load and allow the patient to drink water Baseline Figure Baseline Select Cancel to stop the study 18 6 Water Load During this part of the study the patient drinks water When the patient is finished drinking water enter the amount in the screen shown below If you don t enter the amount of water ingested here you will have to do so at the end of the study Water Load Ingest water Iv az Amount of water ingested i ml Start study Cancel Figure Water Load Select Start study to begin recording the signals for the 30 minute post water period Select Cancel to stop the study 50 18 7 Postwater Recording Select Begin Study from the screen shown below to start recording the signals Study phase Begin study Extend test for 10 minutes Figure Study Phase This lasts for 30 minutes The count down clock in the upper left corner of the screen shows the time remaining in the baseline period During the study you are asked to enter the respiratory rate for each of the 3 ten minute periods with the following screen Respiration Rate Please enter the respiration rate per minute First 10 minute period Figure Respiration Rate The respiration rates may be used to suggest a diagnosis If you d
38. ist and the 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 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 is 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 23 Navigating the Baseline and Post water Periods Navigating between the baseline period and the post water 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 If the study as an extra 10 minute post water period there will be an additional menu item for the fourth 10 minute post water period e Use the Goto menu at the top of the screen Select from the menu items to go to the specified period e Use the Analyze menu at the top of the screen Select from th
39. luded in the first page of the report 21 Reports Reports are only available after the entire study has been analyzed The standard report consists of 2 pages organized as follows e Page Facility information at top of page Left side o Patient name o Date of study o Attending physician o Referring physician o Technician 58 o Indications o Diagnosis o Recommendations o Signature and date Right side o Summary graphs o RSA e Page 2 Raw data graphs of the selected minutes One graph per period 21 1 Configuring Reports can be configured to include two additional items e Data Sheet as page 3 e Graphs of the entire raw signal starting on the next available page until all graphs are printed Configure the graphs by selecting Report from the top menu and then selecting Configure Report The following screen is displayed Configure report Iw Data sheet Cancel Figure 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 59 21 2Facility 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 FacilityPractice name Address Address CO City State ZipCode Phone
40. nals Select Cancel to stop the study You will be asked if you are sure you want to cancel the study 18 8 8 Post Stimulation Recording Select Begin Study from the screen shown below to start recording the signals Study phase 13 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 it 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 is 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 19 8 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 o
41. nce the program is started the main screen is displayed 8 Research Version 3CPM EGGSAS File Edit View Goto Analyze Report Help D P R For Help press F1 Figure Opening Screen 5 2 Selecting a Patient to Choose Which Version 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 L from the toolbar just under the top menu e Select File from the top menu then select New Study and then select New Patient Research Version 3CPM EGGSAS mim Edit View Goto Analyze Report Help Mew study Spee Mew patient Open prior study Cbrl 0 Existing patient Resume Study Backup or Restore Print Setup 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 6 Selecting Which Version When you select File New Study and choose either option the following selection box will appear study Type select Study Type Standard Study Iw Research Study This is when you select the type of study you wish to record 10 7 USING THE RESEARCH VERSION 8 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 8 1 Selecting a Patient
42. ndations Cancel Help Figure Patient Recommendations Enter your recommendations and select OK to cause the program to accept the recommendations 8 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 peri Post stimulation period 2 Post stimulation period 3 Change Respiration Set Respiration Cancel Help Figure Edit Respiration Rate e Select Edit from the top menu and then select Respiration 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 28 9 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 Cancel Figure Warning Save Patient You
43. nds 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 18 3 Pre study Information Pre study information is entered through the following screen Pre study information i Time of pre test meal 8 10 PM T Indication Far procedure Nausea GERD Pastprandial fullness Vomiting Eructus Bloating Early satiety Additional Indidcatianz I Attending physician Referring physician Technician cancel 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 just 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 either click on the up and down arrows to change the minutes or just 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 just type in the AM PM Select any of the Indication for procedure items that apply and or enter any Additional Indications 48 Enter the Attending physician the Referring physic
44. nected 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 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 ae PFMiPgEr S xM tI does NT a teeta P 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 is a USB device it can be unplugged and plugged back in between studies with the program open 2 2 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 my
45. nute end minute 7 5 8 0 2 200 gt E 0 c Are er y Pe rmm re Ne Good minutes 0 0 7 5 2 440 P C Boso t Reject 2 420 us n lec 0 1 2 3 4 Select new minutes Minutes Stat minute 0 0 4 End minute 10 0 H a 200 E F 0 AV SPP PIS JP Ne SS A Undo changes Accept changes Micro Volts A Aa M A ecco Minutes 8 9 10 11 12 Minutes For Help press F1 Figure Main Screen Analyze You may now select your own good minutes by changing the start and end minutes using one of the two following methods e Place the cursor in the appropriate field Start minute or End minute and type the minutes The minutes must be either whole minutes or half minutes e Use the up and down arrow keys to scroll the minutes by half minute increments 53 The selected minutes must be at least 4 minutes apart and must be within the 0 to 10 minute range When you are satisfied with the minutes you selected click on Accept changes If you want to go back to the original selected minutes click on Undo changes 18 8 2 Analyzing Post water Periods Post water periods are analyzed in 10 minute periods For each 10 minute period the raw EGG and respiration signals are displayed for the selected period The same procedure is used for selecting the good minutes to analyze as in the baseline period see above 18 8 3 Diagnosis Once all the periods baseline and 3 post water periods have been analyzed you may have the progr
46. o not enter them during this part of the study you may enter them later see the section on Respiration Rate If you do not enter the respiration rate you may leave the screen displayed during the study and select OK at the end of the study 51 At the end of the 30 minutes there are 2 options e Select Extend test for 10 minutes This continues the study for another 10 minutes At the end of this extra 10 minutes you select Finished to complete the study Under this option the system will not attempt to select minutes and make a suggested diagnosis e Select Finished to complete the study If the amount of water ingested has not been entered you will be asked to entere it before the study can complete Select Cancel to stop the study 18 8 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 ll You can also select File from the top menu and then select Save patient When the study is complete the raw EGG and respiration signals are displayed for the baseline period Artifact has been selected and the longest period of minutes in the baseline without artifact is displayed for you to accept or reject H V F 3CPM EGGSAS File Edit View Goto Analyze Report Help Dei x4 Ep RA oo BR VF 02 13 2004 Baseline X Artifact start minute end minute 7 5 8 0 200 E 0 Good minutes 0 0 7 5 440 P ES e m RA
47. oelectrical 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 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 EPD 3 Preparation for Recording NOTE THE FOLLOWING SECTION APPLIES TO BOTH VERSIONS OF THE PROGRAM 3 1 Preparing the Patient l Prepare to position the EGG electrodes as shown a The RED EGG lead wire and electrode is positioned in the mid clavicular line left side approximately two inches below the left costochondral margin b The BLACK EGG lead wire and electrode is positioned at the mid point between the xiphoid and umbilicus c The GREEN EGG lead wire and electrode is 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 pe 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 o
48. ost tmulattop PerlOG Ls cedo sen eset tasei tese Cabo doa roten du tole tence 20 9 1 3 Chan sine E Ves dut ii ce teet erbe ane unser e tenance s See Lr ee uad Ex 30 9 1 4 vain ass RU 30 9 2 Chanesine the DI3StnOSiscni eue ui So U pent ial poh ond pu ee IAS ORM tha aRidaS De DotA PUER IA a pM neues 30 9 3 Changine the RecomimoendatlOn cius eub Eee sues E et bubo ao do etaed ieu Uo die 30 9 4 Changing the Pre study Information sss 3l 95 BS UTD VEL OWNS d lll Sonne faeces pace settee E ec CM IM An cu EL teet tee meee 31 9 6 Change number Or minutes per raph ode dsen ei ratto axxo e adobe 3l 10 WW ett TT SCC ai C DBODs dedos cuo oreste ica ean casa ccm t de a ricas bu pd uoce aD dou 22 10 1 No Prior What If Scenarios eder EE ee bete Ehe oet uve bete gt eve bi due ope ar edo dt aee Gees 32 10 2 SXBOE FE SCOHOE OS ducedreetuis Scb eoe tum REEL cee DTE QU oe 33 10 5 Saving What H Scenarios and Studies iis csi m edd een dva tos ovo teal aS ci Reed rada 33 11 ijs T MN RR RR E EO 34 12 R DONS 4 tons ue ioo os EHI E o D Mte ok ortu S Mti ERR Te tee a us MIEL RID LOADS 34 12 COnN SUIT IG 25g aii per oup a Eesti uo eeu e Uu be bti esi us te dads eda Exe beg cb 35 12 2 Pacii normalo code iie oet Ie obe dte a cot de itese aduentu dieat ud 36 SV ite We o coieciinicdoti divos e OE E tulerit deed disi ES 36 13 Patient Information au potete bait ees ibo pda acute t eq at E R 37 13b
49. ows 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 14 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 8 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 is 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 Micro Volts 5 Ms 0 4 0 1 2 3 Minutes Start Equipment Test Respirato
50. piratory rates 1f you didn t enter them during the study or modify them using this screen You can display the screen using the following method e Select Edit from the top menu and then select Respiration Respiration First 10 minute period i Second 10 minute period n Third 10 minute period n Cancel Figure Edit Respiration Rate Enter the respiration rates for each 10 minute post water period Then select OK to cause the system to accept the rates 55 19 Selecting an Existing Study To select an existing 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 r4 e Select File from the top menu and then select Select Patient If you 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 Cancel 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 patients 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 is not displayed The program keeps the current patient and stu
51. play is automatically selected Now the Recall and Delete buttons are enabled A What If scenario is loaded by either double clicking on the 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 10 3Saving 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 bad 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 23 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 1s 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 11 HSA The RSA is a g
52. raph of the spectral estimates of the EGG signals in 4 minute epochs lei Kh 4 NO ROM Re Dx me FT MY Stimulation medium phase SLi 1 g Frequency CPM TIO D6 04 7 008 The full screen RSA graph can be viewed using one of the following methods e Select the RSA icon from the top of the screen e Selecting Analyze from the top menu and then select RSA The graph is also included in the second page of the report if included in the report see Configuring Reports 12 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 34 Patient information Patient name Date of study Attending physician Referring physician Technician Indications Stimulation medium Diagnosis Recommendations o Signature and date Page 2 RSA Page 3 plus required additional pages Raw data graphs of the selected minutes One graph per period O O O O O OOOO 12 1 Configuring Reports can be configured to include exclude the following items 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 Event log Configure the graphs by selecting Report from the top menu and then selecting Configure Report The following screen is displayed
53. re you want to stop the baseline Press Yes to stop the baseline No to continue the baseline If you select Cancel it will stop the study 8 7 Post Baseline Options At the end of the baseline there are 3 options 1 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 17 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 ees Help Figure Stimulation Medium Select Start study to begin recording the sig
54. ry sensor Q Gastric electrodes Equipment Test Select Cancel to stop the study 245 8 5 1 Equipment Test Failure Error After a given period of time if the signals do not stabilize you will see the following warning Equipment Test The signal is WOT stabilizing Select one af the Following To continue in manual mode select OF To cancel the kest select Cancel Cancel otar Equipment Test Respirator sensor a epee aeons Ere im bpasslime Gastric electrodes EJ Cancel 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 8 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 lt 16 Baseline Stimulation Medium 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 su
55. 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 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 45 17 USING THE WATERLOAD VERSION 18 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 18 1 Selecting 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 L1 from the toolbar just under the top menu e Select File from the top menu then select New study then select New patient 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 then select Existing patient e Then a screen is displayed that allows you to select the patient for the study Select Patient Curent database of patients I m e Ozo Tgl F J M M RH R MW MW pu Select patient database Cancel Figure Select Patient for Study You select the p
56. t If window is available The data in a What If scenario is as follows Period start minutes Period lengths Selected good minutes Respiration rates 10 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 Date Time Description MEW Original study 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 After the description is entered select the Save button to save it 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 is displayed above the graphs and to the right of the period dropdown list 23 10 2 What If Scenarios The What If window 1s displayed as follows if there are What If scenarios for a study What If Scenario NEV Original stud 2008 02 08 14 56 5 Description 5 periods Save Recall Delete Close Help Figure What If Scenario with What If scenarios The list is ordered by descending date and time i e the most recent date and time is 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 dis
57. tive way to accomplish this is to use the Reset Periods button allowing you to 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 is the recommended method 23 8 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 P from the top of the screen e Select Edit from the top menu and then select Diagnosis The following screen is displayed Diagnosis Suggested diagnosis Diagnosis Type diagnosis here Cancel Help Figure Diagnosis When you are finished writing a diagnosis select OK to cause the program to accept the diagnosis 8 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 is displayed Patient recomme
58. to the directory including Network directories or drive where you want to backup the data to and select Save For example 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 is changed to Backup Restore Data Restore Backup to Start File being copied Help Figure Backup Data 42 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 15
59. 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 62 e Cancel The changes to the patient and or the study are not saved The selected study is 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 toit This is done in the same manner as described above 22 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 O21 3 2004 Post prandial EGG ts suggestive of Probable T achygastria Date Diagnosis temoub L ancel Figure Diagnostic History You select a diagnosis by selecting the Date of study i 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 G3 You can go to the selected study in one of two ways e Select the study from the l
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