A&D TM-2430-13 manuale d’uso

TM-2430-13 (Doctor P ro) Ambulatory B lood P ressure M onitor Data A nalysis S oftw are INSTRUCTION M ANUAL WM:PD40 00019 C[...]

1 CONTENTS 1. INTRODUCTION ......................................................................................................... 3 1-1 About the Data Anal ysis Soft ware ........................................................................................... ........3 1-2 Symbols ..............................................................[...]

2 2-7 Recorder Me nu .............................................................................................................. ............... 31 2-7-1 Retrie ving Data from the Monitor ......................................................................................... ...... 32 2-7-2 Clearing T he Monitor’s M emor y ..................[...]

3 1. INTRODUCTION 1-1 About the Data A n a l ysis Soft w are Welcome to t he Ambulatory Blood Pr essure Monit or ( ABPM) Dat a Analys is Softw are. This software is intended for use with t he following devices. ABPM: For d iag nos ing high bl oo d pressure 1) A&D TM-2430 Serie s Ambulator y Blood Pressure Monitor 2) A&D TM-2420 /TM-2421 Amb[...]

4 1-2 Symbols The sy mbo ls print ed on the dev ice h ave the fo ll ow ing meanin g: CE mar king SN Se rial number 1-3 Monitoring De vice Re v iew The follow in g section briefly rev iews the dev ices a nd how they may be used with this so ftware. A&D Ambul ator y Blood Pres sure Moni tors are u sed to re cord an indi vidual’s bl ood pre ssur[...]

5 1-4 Softw are Package Compone nts Items includ ed in y our complete so ftware package are: ♦ ABPM 3.5-inch progra m dis k ♦ Ambulatory Blood Press ure Monitor Data An alysis So ftw are I nst ruct i on Manual ♦ For TM-2420/TM-2421 AX-KO60 0 (9 pi n D- SUB, soc ket t y pe), Communication cable for TM-242 0/TM-2421 ♦ For TM-2430 series/UA-76[...]

6 2. OPERATING PROCEDU RE 2-1 Getting Star ted Two init ia l action s may be executed when st arting up th e softw are: (1) Data may be retr iev ed from the monitor. (2) Stored data files may be opene d and v iewed for ana ly sis. To retrieve dat a from the monitor, see: ♦ “ 2-2 Communicati o n Between t he Monitor and the S oftware ” To view[...]

7 Step 1 Connect the monitor to the proc essor. Step 2 Connect the male e nd of the A &D-suppl ied RS-232C co mmunicatio n cable t o the processor. Step 3 Connect t he female e nd of the A&D-sup plied RS-232 C communic ation cab le to the computer. Step 4 The display on the processor will show “0-----”. If the process or does not hav e [...]

8 Step 3 The display on the monitor will show “----”. If “----” does not appear, see “ 3-2 Communication Errors ”. Otherwise go to step 4. Note : If possib le, keep the cab le conn ected to the com puter unles s the port is need ed for other functions. Step 4 Run the softw are. Step 5 Confir m that the correct seri al port and the corre[...]

9 2-3 Main Screen Descri ption The ma in screen is comprised o f six menus and two tool bar button s located permanent ly along the top of the scre en. These men us may be used to acce ss the variou s features of the software. The toolbar butt ons may be used to set Part i al Analy sis an d Blood Pres sure Mode par a meters. Toolbar Buttons: (Only [...]

10 2-4 Toolbar There are tw o t oolbar b uttons which ap pear under neat h t he main menu bar: (1) Analy sis Intervals (2) B P M ode 2-4-1 A nalysis Intervals The Analy sis Intervals feat ure is used to define specifi c periods of time withi n an opened data file for custom data a na lysis. Two int erv als, Full Ana lysis and Part ial Analysis may [...]

11 ♦ Histograms After Part ial Analys is parameters are d efined, the data speci fied with in the parameter s will appear in re d overlayin g the Full An a lysis dat a. 2-4-2 BP Mode The BP Mode is used to sele ct which blo od pressure method will b e used as the primary and secondary cho ices for displaying the blood pressur e measure ment data.[...]

12 To specify t he BP Mo de while view ing an ope ned d ata file, co mplete thes e st eps: Step 1 Select the B P Mode box on the t oolbar. Step 2 Select the des ired BP Mode u sed to view and a nalyz e t he opened d ata file. Figure 5: BP M ode selecti on on toolbar To set a default B P Mode for the software at st art up, see “ 2-9-4 De fault Set[...]

13 2-5-1 Open The File | Open funct ion is used t o acce ss the blood pr essure data with in existin g d ata files. Figure 6: Fil e Open dia log box To open a file, co mplete the fol low ing steps: Step 1 Select t he File men u . Step 2 Select t he Open sub- menu. Step 3 Select a file fro m the directory show n or move to a differe nt direct ory . [...]

14 2-5-4 Convert The File | Conv ert funct ion is used t o create a .CSV (com ma delimited) for mat file from a .dat file that is compatib le with most s preadsheet applicatio ns, includi ng Microsoft Ex cel™. The . CSV file that is created includes DATE, TIM E, SYS, DIA, MAP, PUL h eadings so that the data c an be identi fied correctly when open[...]

15 2-5-6 Print The F ile | Pri nt function is us ed to print reports for one or more data file s according to a user- selected format. Th is enables t he user to gener ate multipl e reports with out having t o open each file separately . To print a report for mult ipl e data files, co mplete the fol low ing steps: Step 1 Select t he File menu, t he[...]

16 2-6 View Menu The View menu may be use d to view numerica l, statistic al and graphi cal data screens. The View menu is dis ab led unless a fi le i s ope ned. For infor mation on how t o open a file, see “ 2-5-1 Open ”. The View menu has the foll ow i ng su b-menus: Menu S ee Desc ription Summary Data “ 2-6-1 Summary Data ” Function for [...]

17 2-6-1 Summary Data The Summary Data screen inc ludes stati stics on the data of the op ened file and may be viewed directly on the screen. Thes e st at ist ics are separated into four data tab s: Full Statist i cs based on al l t he data with in t he file. Partial Statisti cs based o n the data specified i n the Part ial Analy sis para meter. Se[...]

18 Each of the four Summary Data is titled with the name of the tab, file, patient and measur ement method. For deta iled informati on on Summary Dat a scree n listings, see b elow: Summary Data T ab Definition Time Interv al The analy sis period, start ti me/date – end time/date, for the activated Summary Data tab. Valid Read ings The tota l num[...]

19 2-6-2 BP Data List The BP Dat a List functio n display s ind ividual b lood pressure mea sure ment w it hi n an op en data f ile in tabular form. W it h the BP Dat a List, you may input measure ment comments, exclude/in clude a measure ment within the graph ics and statistics or l ink a measur ement to the begin ning of the Trends Screen. The fo[...]

20 Figure 9: B lood Pressure D ata List disp lay 2-6-2-1 Excluding/ I n cluding BP Me as urements It is useful to exc lude a measurement from the Blood Pressure D ata List in cases w here the measure ment is cle arly inc orrect. The so ftware provides a simp le way t o include or excl ude measure ments wh ile viewin g a list. W hen a measureme nt i[...]

21 2-6-2-3 Linking to Tre nds Screen A measure ment may be lin ked to the Trend Grap h by highlight ing an indiv idual measur ement and then cl osing the Blood Pr essure Data Li st. W hen opene d, the Trends Sc reen will be al igned with the time of the highlight ed measurem ent in the Blood Pressure D ata List. This featur e may be used to pinpo i[...]

22 Delimitatio n, Scroll B ar and Linking ♦ ♦ ♦ ♦ Partial Analysis : W hen the Pa rtial Anal ysis fea ture is e nabled, re d bands will appe ar on al l the Tr end Graphs high lighting the p eriod and d ata specified w ithin the Part ia l Analys is parameters. ♦ ♦ ♦ ♦ Sleep : When the Sleep int erval is ide ntified, bl ack bands will[...]

23 2-6-3-1 Viewing the Tren ds Step 1 Select t he Vi ew menu. Step 2 Select t he Tr ends sub- menu. Step 3 You may print t he Trend s Screen by sele cting the Print menu on the Tren ds t oo lbar. Step 4 Click th e W in dows™ close b utton in the top ri ght corner to clos e the Trends Screen. 2-6-3-2 Scaling the Scr een The Tr ends Screen may be s[...]

24 To customiz e the Trends S cree n, complet e t hes e steps: Step 1 Select t he S elect menu on t he t op l eft ha nd corner of the Tren ds toolbar. Step 2 Highli ght the Trend Pa ge Template y ou want to view and click the OK button or double c lic k the Trend Page Template. If an exist ing template do es not meet the requirement s, you may crea[...]

25 Figure 13: B lood Pressur e Trend Setup dia log box Step 8 Repeat st eps 6- 7 to set posit ions 2, 3, and 4. Step 9 To save your t rend template, cli c k the Save button Step 10 To cance l the oper ation, click the Can cel button . 2-6-4 Correlation Plot s The Corre lation scre en offers a conv enient way to view the relat ionship bet ween the B[...]

26 measurements. Measurement statist ics, Mean " m " , S t andard Devi ation " s’ " and Corr elation Coefficient “ r ” values are s hown on the bot t o m of the screen. Figure 14: C orrelation Plot s display[...]

27 2-6-5 Histograms The Hist ograms screen offe rs a conven ient way t o quickly rev iew the overall mag nitude and distribution of the syst olic, diastol ic, mean arteria l blood pressures and pulse (he art rate) measure ments. The fol lowi ng Histogra ms are avail ab le: ♦ Sy st ol i c Blood Pres sure: Full Ana lysis i n blu e, Part ia l Ana ly[...]

28 2-6-6 Circadia n R hy thm The Circad ian Rhyth m screen shows the circa dian rhyt hm of the systolic and dia stolic bloo d pressures, and p ulse (heart rate); obtained using t he 24-hour cosin or analysis. The analysis start ing time coi ncides with th e start time s pecified for th e Full An alysis interval . The Circ ad ian Rhyth m screen also[...]

29 2-6-7 HIB A naly sis The HIB an aly sis screen show s t wo graphs arra nge d vertically . The upper gra ph shows the hy perbalic area (i n red) exceedin g the user-defin ed hyperbalic limit s for the systolic a nd diastoli c blood pressure s, and the numeri ca l data conv ert ed int o a on e-day period. The lower grap h shows the hy pobalic area[...]

30 2-6-8 Patient Information The Pat ient Infor mation sc reen is us ed to store in formation on pat ients a nd their treatment. Thi s is also the in put screen for the p at ient ’s Sleep int erv al. Figure 18: P atient Informati on display The Patie nt I nfor mation scree n has the follow ing data f ie lds: (The character s referred to i n the t[...]

31 Field Descriptio n Insurance Field for the pat ient ’s insura nce i nformation. U p t o 20 characters can be use d. Medicare # Field for the patient ’s Medicare or Med icaid number or other health care number. Up t o 20 ch aracters can be us ed. Medications Fie ld for the patient ’s medicat ions. Up to 60 ch aract ers c an be used. Age Fie[...]

32 2-7-1 Retrieving Data from the Monitor Figure 19: R ecorder-Retrie ve Data dialo g box See below for the de scription of each field on the Recor der-Retriev ed Data dia log box. Field Descriptio n Recorder ID Rec order ID is set in t he monitor’s me mory prior to the mo nitoring session. Start D ate Date of first measurement i n the monito r?[...]

33 Step 7 Clic k th e OK button. Note : To view a retr iev ed file, you m ust open it. 2-7-2 Clearing Th e Monitor’s Memory The mo nitor’s memory should be cleared be fore each monit oring session. With the mon itor and the processor connect ed to the computer, you may clear the measurement data stor ed in the monitor by completi ng t he steps [...]

34 2-7-3 Programmin g the Monitor’s Interv als and Co ndi ti on s 2-7-3-1 TM-2420/T M-2421 S etu p With the monit or and the processor connected t o the computer, y ou may setup or ch ange the followin g monitor con dit i on and interv al s ettings: Item Definition Recorder I D number Monitor (or pat ient) ID number (01 thro ugh 99). Thi s is use[...]

35 Figure 21: TM -2420/TM -2421 Recorder Setup dialog bo x Step 3 Select the R ecor der ID field. Input a R ecord er ID number betwee n 1 to 99. Step 4 Selec t the Displa y check box to s et the displa y to On or Off . Step 5 Select the B uzzer check box to set t he buz zer On or Off. Step 6 Select the T ime field for Perio d One (1) and enter the [...]

36 Step 13 Select the I nterval drop-down menu for Period Three (3) an d set the measurement Interval for Per iod Three (3) to: O FF, 1, 3, 5, 10, 15, 20 , 30, 60 or 120 minutes. Step 14 If you want t o program a fourth p eri od, go t o st ep 15. If you do not want to program a fourth per iod, go to step 17. Step 15 Select the Time field for Period[...]

37 2-7-3-3 Examples of Pr ogrammin g the Monitor Note : The procedure is t he sam e for the TM-2420/TM-24 21/TM-2430, ex cept periods 5 and 6, whic h are ava ilable only with the TM-24 30. (A) Example: Programming the Monitor for One (1) Period Suppose that the start time of the monitoring se ssion is 09:00 a nd you would li ke the monitor to measu[...]

38 (B) Example: Programming the Monitor for Three (3) P eriods Suppose that the start time of the monitoring se ssion is 09:00 a nd you would li ke the monitor to measure the patient's b lood pressure every 30 minutes until 22:00, and from 22: 00 to 07:00 onc e an hour, and from 07:0 0 you would like the blood pressur e meas ured every 15 minu[...]

39 (C) Example: Programming the Monitor for Four (4) P eriods Suppose that the start time of the monitoring se ssion is 09:00 a nd you would li ke the monitor to measure t he patient's blood pres sure every 30 minutes unt il 22:00, and fro m 22: 00 to 23:00 you want the monitor OFF so that the patient may sleep, and from 23:0 0 to 06:00 y ou w[...]

40 2-7-3-4 UA-767PC Set up When the U A-767PC connected to a persona l computer, times to generate a beeping sou nd can be set. To se t the times , complete the fo llowing ste ps: Step 1 Select t he Recorder menu. Step 2 Select t he Setup sub- me nu. Th e Recorder Set u p dialog box a ppe ars. Figure 26: UA- 767PC Record er-Setup dialog b ox Step 3[...]

41 2-8 Report Men u Custom report formats may be saved for future use throug h the Report menu. The following functions are av ailable in t he Report dia log b ox: ♦ Create a new report templat e ♦ Edit an existing report t e mplate ♦ Delete an existin g report t empl ate ♦ Save an existing te mplate as the d ef au lt report style ♦ Print[...]

42 2-8-1 Creating a Ne w Report Tem plate Step 1 Clic k the New b utton on the Rep ort dialog box. Th e Report Setu p dialog box will appear. Figure 28: R eport setup dialog box Step 2 Type the Re port Name. Step 3 Edit t he Report Heading. Th is headin g will appear on the top of every page alon g with the file n ame and ti me the file is printe d[...]

43 2-8-2 E diting an E xisting Rep ort Template Step 1 Highli ght the report te mpla t e you want t o edit . Step 2 Clic k th e Edit butt on. T he Report Setup d ialog box will ap pear. Step 3 Edit t he Report Na me. Step 4 Edit the Report He ading. The R eport Headin g will appear on th e top of every page along with t he f i le na me and time the[...]

44 2-9 Options Me nu The Options menu may be us ed t o acce ss default and v arious for matting screens w ith in the softw are. The follow in g Options fe at ures are availa ble: Menu S ee Descrip tion Report For mats “ 2-8 Re por t Menu ” The Rep ort formats may be used t o create and save custo m report for mats. Physic ians Lis t “ 2-9-2 P[...]

45 The follow ing instruct ions outl in e t he various Phy sician List f eatures av ail able. 2-9-2-1 Addi ng a Ne w Physi ci an to th e List Figure 30: P hysician Entr y dialog bo x Step 1 Clic k th e New b ut ton on the Phy sician L ist di alog box. The Physic ian Entry dialo g box will appear. Step 2 Enter the appropr iate data. Note : All field[...]

46 2-9-4 Default Settings There are three de fault settin gs i n t his so ftware: 1) Blood Pressure 2) Serial Port 3) Recorder Type 2-9-4-1 BP (Blood Pre ssure) Sett i n gs (Av ai l abl e only for TM-2420/TM-24 21 a nd TM-243 0 d ata) Edit t he De fault Bloo d Pres sure Setting s as follows: Step 1 Select the Mea surement Method (B P Mode). Step 2 [...]

47 2-9-4-2 Serial Port The ser ial port is used t o communicate b etween t he monitor and the computer. The serial port setting and the port use d for communic ation must be the sa me. Figure 32: D efault Serial P ort Selection di alog box 2-9-4-3 Recorder Ty pe Figure 33: D efault Record er Type dialog box The def ault Recorder Ty pe function is u[...]

48 3. TROUBLESHOOTING 3-1 Measurement Err ors The follow ing tables list the error messages that may occur d uring a monitori ng session and offer informat ion on possib le c auses and correct i ons. Measure ment errors may be sh own on the b lood pressure dat a list disp lay and pr inted text dat a. If an error occurs (indic ating by ast erisks), [...]

49 ERRO R CO DE POSSI B LE CA USE CORR E CTIO N E07 Manual stop The measur ement was ma nually interrupted by depression of the red Start/Stop but t on. E08 Korotkoff sou nds are undetect able. Check that t he lower micro phone is affixed with the sens ing side (skin side) facing the pat i ent’s arm. Note : The microphon e should always be taped [...]

50 3-1-2 TM-2430 Series Error Co des ERRO R CO DE POSSI B LE CA USE CORR E CTIO N E00 Clock parameters hav e not been set. Enter clock parameters. E03 An error code is dis played without cu ff inflatio n. Exhaust t he air from the cuf f co mp let e ly. E04 Measure ment is stopped du e to a low ba ttery. Repla ce with new bat teries. Aut o mode is q[...]

51 3-2 Communication Errors When c ommunicat ing betwee n the monitor and the P C, the follow ing dialo g box may appear i f the communic at ion setup is not per formed prop erly: Figure 34: C ommunicatio ns Error dialo g box If thi s error occurs, com plete the ste ps below: Step 1 Clic k th e OK button on the Error d ialog b ox. Step 2 Check the [...]

52 3-3 Missing Files If you can not find your files in o ne of the F ile menu screen s, and the f iles have not been delet ed, check the fo llowin g: ♦ The folder specified in the Recorder-R etrieved Dat a dialog box i s the same folder as specifie d using the F ile | Open fu nct ion. ♦ No changes have be en made to the file extensio n .dat. 3-[...]

53 4. PRINTOUT EXAMPLES Figure 36: P atient informat ion – Text d ata[...]

54 Figure 37: S ummary data (Fu ll and parti al) – Text data[...]

55 Figure 38: S ummary data (Awa ke and sle ep) – Text dat a[...]

56 Figure 39: B lood pressure data – Text d ata[...]

57 Figure 40: Tren d graph (Blood pressure an d double pr oduct) – Gra phical dat a[...]

58 Figure 41:Co rrelation pl ots (upper) and histogram p lots (lower ) – Graphi cal data[...]

59 Figure 42: C ircadian rh ythm plots (upp er) and HBI analysis plo ts (lower) – Gr aphical da ta[...]

60 Figure 43: “M ini” report -1[...]

61 Figure 44: “M ini” report -2[...]

62 5. TERMS/ABBREVIATIONS 5-1 Terms Relate d t o Bloo d Pressure Term/Abbreviation Descript ion Oscillometric Oscillometric met hod o f blood pressure measurement. Korotkoff Korotkoff method of blood pressure measurement. SYSTOLI C, SYS, SBP (Systolic Blood Pressure) Blood pre ssure that occurs when t he heart contracts. DIASTOLI C, DI A, DBP (Dias[...]

63 Term/Abbreviation Descript ion CORRELAT IO N: r (Coefficient of Correlat ion) Indicates the degree of linear relationship between two v ariables. I t ran ges from +1 to -1. A correlation of +1 means that there is a perfect positive linear relat ionship between variables. Sys – dia In the plotted 2 4-hour blood pressure data, indi cates hi gh b[...]

64 Term/Abbreviation Descript ion c.i., Confidence Interval Interval surrounded by the con f idence limit of 95%. 95% conf idence interval i s expressed in numerica l data with the c osinor analysis graph. PR (Percent Rhythm) Rhythm compatibility Squared multiple correlation coeff icient (R) between the measured value and the cosine curve best f i [...]

65 5-4 Ter ms Related to the Risk Man agemen t of High Blood Press ure Term/Abbreviation Descript ion Hyperbalic Index, HBI High blood pressure index Hypobalic Index Low blood pressure index Hyperbalic Ar ea Time integral of the blood p ressure values exceeding the limits. 24-hour blood pressure data is plotted on a trend bar graph and an integral [...]

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