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ABPM 7100 HMS 5.0 Software User Manual

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1. Address Medical history leet laca Fist ama From To Disease Notes Doe John Street Address 2 Baker Street Zip Code City Country Phone Fax number Mobile 44123456789 email john doe com New entry Delete entry Patient data Blood pressure limits Medication a OA From To Trade name Active agent Dosage 999999999999999 ABPM Values A asi Average Values dl Wee Ra oe Day 135 85mmHg 180 82 0 25 3 No Night 120 75 mmHg Date of birth mm dd yyyy Age Gender Total 130 80 mmHg 08 02 1945 69 Male Single Values Day 140 90 mmHg Night 125 80 mmHg Self measurements a 135 85mmHg Emergency contacts Last Name First name Phone Relationship New entry Delete entry New entry Delete entry The patient s name and date of birth will be displayed on the top right of the application window The Patient Information tab features several areas Address Patient data Emergency contacts Medical history Medication and Blood pressure limits Displaying the patient s measurement data 1 Click the Blood Pressure tab and a list of previous measurements will be shown on the left MS sowon yl gt File Patient Measurementseries Settings Patient John Doe 08 02 45 WelchAllyn BO 2 26 G Patient information Blood Pressure l Pulse wave analysis q Office BP Monitoring El ja Jen p G il
2. MAX JMN 2 Pie ieee we 08 11 12 A 08 12 12 Measurements a Num Date Time Sys MAP Dia Hr cSys cDia Code Notes Y 24h ABPM 11 02 27 12 10 44 106 81 60 87 97 61 230 Start einer manuellen Messung ae 2 02 27 12 10 45 106 85 67 87 96 68 3 02 27 12 11 00 100 78 60 85 90 61 lap 05 29 12 4 02 27 12 11 15 106 82 62 83 97 64 5 02 2712 11 33 117 87 62 84 ae ica 6 02 27 12 11 45 116 84 57 90 95 62 E 06 13 12 7 02 27 12 1203 137 111 88 89 el 02 2712 12 15 120 93 70 84 109 72 9 022712 12 30 102 81 64 79 92 65 10 02 27 12 12 48 118 90 68 89 141 02 27 12 13 00 118 87 60 76 111 62 12 02 27 12 13 15 102 78 58 76 94 59 13 02 27 12 13 30 99 76 57 75 91 58 44 02 27 12 13 45 99 78 60 76 92 61 15 02 27 112 14 00 114 88 66 77 108 67 146 02 27 12 14 15 107 85 66 71 98 66 47 02 27112 14 30 109 88 70 68 101 70 18 02 27 112 14 45 116 91 69 71 110 70 19 02 27 12 15 00 143 100 64 74 134 67 20 02 27 12 15 15 122 94 70 71 116 71 02 27 12 15 33 2 Pulsbasisbreite ist gr er als in MAX_BEAT_WIDTH definiert 21 02 27 12 15 45 111 88 69 73 104 70 22 02 27 12 16 03 111 94 80 75 23 02 27 12 16 18 125 98 75 81 24 02 27 12 16 30 120 90 64 75 101 68 25 02 27 12 16 45 110 90 72 76 105 73 26 02 27 12 17 00 116 90 67 74 106 68 27 02 27 12 17 15 120 102 86 76 115 88 28 02 27 12 17 30 117 89 66 83
3. To print cl Print range ad _ Patient information sheet Report Trends ar Ena 3 Customization Measurements Printer _ Exceeding norms C Rise and Fall Page format Frequency di Scatter Points int veas C Total C Total D saveaspo Oo C Day C Day C Night C Night Hourly Intervals 41 Monitoring at the doctor s office Comparing several measurement results If more than one measurement results are saved under one patient it is possible to compare these results Depending on the analysis diagrams of individual measurement results are displayed in a list or the values are accumulated and graphically displayed Selecting and comparing several measurement results 1 Click on the first measurement result to highlight the measurement 2 Hold the ctrl or command key and click on other required measurement results to highlight them 3 Click on the required analysis tab Example Comparing the bar charts of two measurements A WW 5 no co Ss 6S H F ALA A ee A ure mmHg DIS a ma O Blood Press xe lt o lt o ure mmHg ee O A A AN o O t 200 Joso Blood P H H aun Monitoring at the doctor s office The ABPM 7100 can be carried by the patient in the doctor s office e g in the waiting room and the measureme
4. 2 Todisplay an individual PWA click on the Measurements tab 3 Click to select a value in the table and the following window will appear displaying further details Peripheral pulse wave measured 11 20 2014 09 59 Blood pressure Systole 122 Diastole 91 MAP 105 Pulse pressure 31 Heart rate 58 cSys 115 cDia 92 cPP 23 Pulse pressure amplification Hemodynamic Stroke volume ml Cardiac output l min 47 Total vascular resistance s mmHg ml Cardiac index l min 1 m 23 Arterial Stiffness Augmentation pressure mmHg 4 Reflection Magnitude 52 Augmentation Index 75 90 Cl 6 17 38 PWV 90 Cl m s 9 9 8 7 10 2 Vital statistics Height 500 600 700 Weight msec Body Mass Index BMI Reflection wave Body surface area ery good data quality Reliable results 0 1 2 3 4 5 6 7 sec Central pulse wave calculated This displays the PWA in the same way as an individual PWA performed at the doctor s office 40 Analyzing the measurement The Amplification tab This analysis is used to monitor the variation of the difference between central and peripheral blood pressure values The blue area indicates the difference between peripheral and central systolic values during the daytime and the grey area indicates the difference between peripheral and central diastolic values during the daytime Amplification mmHg a The Print tab The print function allows you to print out specific analyzes
5. ABPM 7100 is a trademark of Welch Allyn Inc The copyright for the firmware in this product remains with the manufacturer of this device All rights reserved The firmware may not be read out copied decompiled redeveloped disassembled or brought into any human readable format This does not pertain to the sales of firmware or a firmware copy All usage and ownership rights to the Software remain with E M GmbH Welch Allyn Technical Support http www welchallyn com about company locations htm E M GmbH Cockerillstr 69 52222 Stolberg Germany Manufactured for Welch Allyn WelchAltyn Advancing Frontline Care CE 0044 3 Table of contents Table of contents Symbols Introduction Preliminary note About this directions for use Safety relevant information Intended use Description of the HMS Working with HMS Installing the software Provisions for Cyber Security system requirements Installation for Windows Installing the HMS from CD Installation for Macintosh OS X 10 7 5 and above Installation for Linux Installing the Bluetooth driver Installing the USB driver Starting and exiting the HMS Structure of the HMS application window Menu bar Toolbar Activating Pulse Wave Analysis PWA First steps with the sample patient Displaying the patient Displaying the patients measurement data Editing patient information Creating new patients Selecting existing patients Modifying patient data
6. Here you can specify the joint directory of the HMS and your office IT HMS and office IT must have the same directory settings The HMS program directory should preferably be set first In the field PMS gt HMS File enter the name of the GDT file which transmits the patient data of your office IT to the HMS The same name must be set in the HMS and in your office IT In the field HMS gt PMS file enter the name of the GDT file which transmits the report of the HMS to your office IT The same name must be set in the HMS and in your office IT Enter the start file HMS_GDT exe into the settings of your office IT 52 Reorder No Material No DIR 106292 722998 80019795 Ver A WelchAllyn Advancing Frontline Care
7. bt flash on the display 24 Working with the ABPM 7100 7 Press q bt no longer flashes and the buzzer sounds On the computer 8 The Device Action window appears On the ABPM 7100 9 The buzzer sounds twice On the computer 10 Click Prepare device to display the Prepare device window Note If the battery voltage in the measurement device is insufficient for a 24 hour measurement the following warning will appear Attention A The minimum battery voltage for a 24h measurement should be 2 60 Volts The voltage is only 2 54 Volts Note Before use make sure that any previous measurement results stored in the ABPM 7100 are deleted to avoid incorrect value assignment You can also delete measurement values manually on the device please refer to the ABPM 7100 directions for use 11 Specify the protocol for 24 hour measurement 12 Click Set clock on device 13 Click Send Patient ID 14 Click Send and activate 15 Click Save On the ABPM 7100 16 The buzzer sounds 17 The letters bt End flash in the LCD display followed by the time On the computer 18 In the toolbar click y to exit the HMS Starting 24 hour measurement Ensure the ABPM 7100 is switched on CA For further information on your ABPM 7100 please refer to the directions for use of the ABPM 7100 On the ABPM 7100 1 Setup the ABPM 7100 on the patient position the cuff and connect it to the ABPM 7100 2 Pre
8. 102 69 02 27 12 17 48 3 Oszillation ist zu hoch Grenzwert 29 02 27 12 18 00 118 93 72 80 107 73 30 02 27 112 18 15 119 95 75 79 108 76 34 02 27 12 18 30 121 93 69 83 111 71 32 02 27 12 18 45 108 94 81 86 97 82 33 02 27 12 19 00 124 90 62 86 109 65 34 02 27 12 19 15 135 98 67 84 123 70 35 02 27 12 19 30 136 95 60 83 120 63 36 02 27 12 19 45 127 95 69 86 114 71 37 02 27 12 20 00 130 95 65 89 117 67 38 02 27 12 20 15 124 106 91 104 118 93 39 02 27 12 20 33 143 108 79 102 40 02 27 12 20 45 131 99 71 99 116 72 41 02 27 12 20 48 139 103 LE 102 122 75 230 Start einer manuellen Messung 02 27 12 21 03 3 Oszillation ist zu hoch Grenzwert 42 02 27 12 21 08 126 96 71 115 123 Die Tag Nacht Taste wurde innerhalb des vorgesehenen Zeitfensters bet tigt Es wurde in den Tag Nac 98 65 36 84 89 36 99 72 49 80 92 51 za zal mel cal Report 16 Editing patient information 2 Click to select a measurement The respective measurement data is then displayed Highlighted measurement values are values exceeding the specified limit values 3 For additional analyzes click the required analysis tab Tip If you use the mouse to hover over a symbol a brief tooltip will appear The toolbar with the analysis tabs D
9. Changing the Patient ID Blood pressure limits Deleting a patient Audit Trail Working with the ABPM 7100 Pairing via cable Pairing the computer to the ABPM 7100 via the USB interface cable Configuring the interface between the ABPM 7100 and the HMS Preparing the ABPM 7100 for 24 hour measurement Starting 24 hour measurement Connecting the computer to the ABPM 7100 via cable after a 24 hour measurement Transferring 24 hour measurement values out from the ABPM 7100 Pairing via Bluetooth Configuring the interface between ABPM 7100 and HMS Preparing the ABPM 7100 for 24 hour measurement Starting 24 hour measurement Transferring out 24 hour measurement results from the ABPM 7100 via Bluetooth Preparing the ABPM 7100 for measurement Setting the measurement protocol 0 0 Y Y NOD FOO O1 OO h _b bh O O O h h h h NO NNNNNNNNN Ee a FH HH mb HK do do do do do M a e M ll o doi N OOP ODNN a O O O O OOO OOO OO JJOO UA AOO 4 Table of contents Setting the ABPM 7100 clock Transmitting the Patient ID Testing the ABPM 7100 Deleting old measurements Completing ABPM 7100 preparation Exporting measurement results Analyzing the measurement The Measurements tab The Trends tab The Bar Chart tab The Scatter Points tab The Exceeding norms tab The Frequency Distribution tab The Summary tab The Hourly Intervals tab The Rise and Fall tab The Trends PWA tab The Amplification tab The Print
10. Code City Country i Phone Fax number Mobile e mail New entry Delete entry Patient data Blood pressure limits Medication Patient ID Server PID From To Trade name Active agent Dosage 4 ABPM Values SA ai Average Values Hees clon ho ew Hi Day 135 85 mmHg 0 0 0 ai Night 120 70 mmHg Date of birth mm dd yyyy Age Gender Total 130 80 mmHg 01 01 1990 24 Single Values i Day 140 90 mmHg Night 125 80 mmHg Self measurements es 135 85 mmHg Emergency contacts Last Name First name Phone Relationship New entry Delete entry New entry g Delete entry The Patient Information tab displays several areas Address Patient data Emergency contacts Medical history Medication and Blood pressure limits Selecting existing patients Select a patient from the patients list previously created in the HMS to e view their previous measurements e prepare the ABPM 7100 for this patient e transfer the measurement values from the ABPM 7100 to the HMS In the toolbar click the Patient List icon to display the list of previously created patient entries al LastName lt Firstname Patient ID Date of birth Last ABPM Doe John 999999999999999 08 02 45 071713 1 Patient Test 01 01 90 Open patient Click to select the appropriate entry and then click Open patient 18 Editing patient information To search for a patient follow the steps below 1 Enter the last name first n
11. Night Systolic Total Diastolic Day Diastolic Night Diastolic Total Acceptable e Too high Normal The Frequency Distribution tab Frequency distributions of systolic and diastolic measurement values as well as heart rate are displayed as histograms Each bar diagram contains the proportional percentages of 10 units i e 80 89 90 99 etc To display the frequency distribution click on the Frequency distribution tab Ho tk e e ie Frequency distribution Systole 3 e Holla Diastole 3 o A Heart rate 3 0 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 1 60 170 180 190 200 210 220 230 240 250 260 36 Analyzing the measurement Selecting measurement values for analysis Use the drop down field on the bottom left to display the required measurement total day night In the display for day and night vertical lines indicate blood pressure limits Note The blood pressure limits can be specified in the Patient Information tab in the Blood pressure limits section The Summary tab The summary contains important statistic statements on systolic and diastolic blood pressure Values for day and night are displayed respectively HA jin 2 To display the summary click on the Summary tab a e YX o h Be me ee 2 Summ
12. analysis Delete 9 Office BP Monitoring S a 1 HRS a P a Ea jua qui Pe E a 08 11 12 A 08 12 12 i f i i Measurements Num Date Time Sys MAP Dia Hr Code Notes 2a 08 12 12 09 00 161 118 97 78 lag 02 27 12 CBP 2 08 12 12 09 02 1631 117 95 76 x 08 12 12 09 04 159 112 89 72 a 05 29 12 08 12 12 09 06 155 110 88 73 08 12 12 09 08 153 110 89 75 06 12 12 E 08 12 12 09 10 1501 108 87 71 a 06 13 12 _08 12 112 09 12 145 105 86 72 08 12 12 09 14 147 105 85 72 08 12 12 09 16 145 105 85 72 08 12 12 09 18 143 103 gal 7l 08 12 12 09 20 145 105 86 69 08 12 12 09 22 146 104 83 72 ahal M1 S S 0c om on swn 5 Report 29 Analyzing the measurement 4 Click to select the measurement results to be exported 5 Inthe menu bar click Measurement series and then Export Excel XML and GDT The Export measurement series window appears 6 Set the directory and name for the file 7 Click Save Analyzing the measurement Once the measurement values from the ABPM 7100 have been transferred and stored from the ABPM 7100 to the HMS the following analyzes and functions are available for measurement analysis and are described in this chapter 1 Select the required patient 2 Inthe application window click on the Blood Pressure tab The Blood Pressure tab contains a list of p
13. blood pressure These measurement values are graphically displayed in a diagram as a function of time e Systolic values e Average values e Diastolic values e Heart rate To display the rise and fall in blood pressure click the Rise and Fall E tab 38 Analyzing the measurement T CICI Y eo ll Be Rise and Fall 195 05 2942 Blood Pressure mmHg 5 u BHUWW e The left y axis with the unit mmHg applies to the systolic diastolic and average values blood pressure values e The right y axis with the unit mmHg h applies to the change in blood pressure e The x axis applies to the time Intervals for increases in morning blood pressure are highlighted e The bottom curve displays the smoothened course of blood pressure Blood pressure data of the average blood pressure are transformed into the frequency range by Fourier analysis e High frequencies are neglected resulting in the displayed curve after inverse Fourier transformation It shows the positive blood pressure change mmHg h for periods of blood pressure increase and the negative change during periods of blood pressure decrease e The red vertical lines mark the beginning and end duration of the early morning blood pressure increase and the time and extent of the maximum increase e The upper blood pressure limits systolic diastolic are displayed as horizontal set point curves Note The blood pressure limits can b
14. calculate the patient s age Note By default the HMS analysis will always refers to the current age of the patient In order to maintain a patient history a printout must be created for each appointment The blood pressure limits for an individual patient can be specified on the Patient Information tab Note The blood pressure limits for an individual patient can be specified on the Patient Information tab Specifying blood pressure limit values for analysis 1 Inthe menu bar click Settings then Blood Pressure Limits to display the following window z measurements 140 Ilao mmHg ABPM Values Average Values Day 1135 ilas mmHg Night 120 75 mmHg Total 130 80 mmHg Single Values Day 140 90 mmHa Night 125 80 mmHg Self measurements 1135 IE mmHg Dipping Inverted lo Non Dipper lt 10 Normal lt 2 0 a 2 Enter the limiting values 3 To accept the new limit values click Save 49 Changing the default settings of the HMS Analysis In the menu bar click Settings then Analysis to display the following window Analysis Initial 1 h after start lal Static beginning 12 With Daw Night button With Day Night button Day Individual Protocol Evening 4 h Before Day Night Change Night Individual Protocol Morning 4 h After NightiDay Change Various analysis settings can be selected e Initial An additional
15. planned measurement to the ABPM 7100 Ensure that the HMS has started and the ABPM 7100 is switched on and connected to the computer The interface between the ABPM 7100 and the HMS must already be configured Please go through the following steps e Specify the measurement protocol e Set the ABPM 7100 clock e Accept the patient ID e Perform device tests e Delete existing measurements e Start 24 hour measurement 1 Select a patient 2 Inthe toolbar click the Prepare device gt icon to display the following window 27 Preparing the ABPM 7100 for measurement ws Prepare device Version 20 Patient John Doe Aug 2 1945 999999999999999 Delete measurements Testing Device Send Patient ID Set clock on device Protocol Protocol 10 v Send and activate y Display of measured values y Bluetooth active Y PWA 1st daytime interval 2nd daytime interval 3rd daytime interval Night interval Start 8 w Clock Start 10 w Clock Start w Clock Start o lock Measurement wih Measurements 30 w yh Measurement w ih Measurement 30 w In Buzzer lv Buzzer lv Buzzer lv Buzzer va Open patient Close Setting the measurement protocol The procedure for 24 hour measurement can be set here In total 11 different protocols are provided The protocols 1 2 10 and 11 can b
16. systolic and diastolic blood pressure Each point corresponds to one measurement To display the correlation click on the Scatter Points tab j HO h ee pie ee 2 Scatter Points s d 1 95d 1 18 PEO UMWOOnN yrowwooo AA fed yy fer pa P Phd te Sve SSS SS i eS 5 OAS KS Ga Gs m 0 Sn ow eon Hg Diastol E Day Night Scatter Points Day Scatter Points Night Total w e The y axis applies to diastolic values e The x axis applies to systolic values e Blood pressure limits are displayed as horizontal systolic and vertical diastolic set point curves Note The blood pressure limits can be specified in the Patient Information tab in the Blood Pressure Limits section Showing and hiding Total Day Night measurements Use the drop down field on the bottom left to display the required measurement total day night The Exceeding norms tab The values of a measurement series are analyzed according to specified blood pressure limits Various pie charts show the percentages of acceptable exceeded and normal measurement values Note The blood pressure limits can be specified in the Patient Information tab in the Blood Pressure Limits section 35 Analyzing the measurement To age the ome limit nen click the e norms e tab Exceeding norms Systolic Day Systolic
17. voltage for a 24h measurement should be 2 60 Volts The voltage is only 2 54 Volts Specify the protocol for 24 hour measurement Click Set clock on device Click Send Patient ID Click Send and activate Click Close oa e In the toolbar click y to quit the HMS On the ABPM 7100 10 Switch off the ABPM 7100 11 Disconnect the cable by removing the plug from the data port Starting 24 hour measurement On the ABPM 7100 You need to perform the steps described below to connect the computer to the ABPM 7100 Please read the directions for use for the ABPM 7100 up to the chapter Measurement Process After 24 hour measurement When using the ABPM 7100 with cable connection perform the following steps 21 Working with the ABPM 7100 Connecting the computer to the ABPM 7100 via cable after a 24 hour measurement After 24 hour measurement transfer the data from the ABPM 7100 to the HMS 1 Ensure the ABPM 7100 is powered off 2 Remove the ABPM 7100 from the patient remove the cuff and disconnect the ABPM 7100 3 Connect the ABPM 7100 to the computer using the USB interface cable a Insert the USB interface cable into the computer s USB port b Insert the USB interface cable plug into the data port at the bottom of the ABPM 7100 Note The red dot on the plug must align with the red dot on the data port 4 Switch on the ABPM 7100 5 The letters co will be displayed on the ABPM 7100 LCD A For fur
18. 0 02 27 12 15 15 122 94 70 71 116 71 02 27 12 15 33 2 Pulsbasisbreite ist gr er als in MAX_BEAT_WIDTH definiert 214 02 27 12 15 45 111 88 69 73 104 70 22 02 27 12 16 03 111 94 80 75 23 02 27 112 16 18 125 98 75 81 24 02 27 12 16 30 120 90 64 75 101 68 25 02 27 12 16 45 110 90 72 76 105 73 26 02 27 12 17 00 116 90 67 74 106 68 27 02 27 12 17 15 120 102 86 76 115 88 28 02 27 12 17 30 117 89 66 83 102 69 02 27 12 17 48 3 Oszillation ist zu hoch Grenzwert 29 02 27 12 18 00 118 72 80 107 73 30 02 27 12 18 15 119 75 79 108 76 31 02 27 12 18 30 121 69 83 111 71 32 02 27 12 18 45 108 81 86 97 82 33 02 27 12 19 00 124 86 109 65 34 02 27 12 19 15 135 67 84 123 70 35 02 27 12 19 30 136 60 83 120 63 36 02 27112 19 45 127 69 86 114 71 37 02 27112 20 00 130 65 89 117 67 38 02 27 12 20 15 124 106 91 104 118 93 39 02 27 12 20 33 143 108 79 102 40 02 27 12 20 45 131 99 71 99 116 72 41 02 27 12 20 48 139 103 73 102 122 75 230 Start einer manuellen Messung 02 27 12 21 03 3 Oszillation ist zu hoch Grenzwert 55583281518 B 42 02 27 12 21 08 126 96 71 115 123 Die Tag Nacht Taste wurde innerhalb des vorgesehenen Zeitfensters bet tigt Es wurde in den Tag Nac 43 02 27 12 21 30 108 79 55 90 The highligh
19. 89 8 02 27 12 12 15 120 93 70 84 109 72 9 02 27 12 12 30 102 81 64 79 92 65 10 02 27 12 12 48 118 90 68 89 11 02 27 12 13 00 118 87 60 76 111 62 42 o2r27ma 13 15 102 78 sa ze 94 50 13 02 27 12 13 30 99 76 57 75 91 58 14 02 27 12 13 45 99 78 60 76 92 61 15 02 27 12 14 00 114 88 66 TI 108 67 16 02 27 12 14 15 107 85 66 71 98 66 17 02 27 12 14 30 109 88 70 68 101 70 18 02 272 14 45 116 91 69 71 110 70 19 02 27 142 15 00 143 100 64 74 134 67 20 02 27 12 15 15 122 94 70 71 116 71 02 27 12 15 33 2 Pulsbasisbreite ist gr er als in MAX_BEAT_WIDTH definiert 21 02 27 42 15 45 111 88 69 73 104 70 22 02 27 12 16 03 111 94 80 75 23 02 27 12 16 18 125 98 75 81 24 02 27112 16 30 120 90 64 75 101 68 25 02 27M12 16 45 110 90 72 76 105 73 26 02 27 112 17 00 116 90 67 74 106 68 27 02 27 12 17 15 120 102 86 76 115 88 28 02 27 12 17 30 117 89 66 83 102 69 i i 02 27112 17 48 3 Oszillation ist zu hoch Grenzwert 29 02 27 12 18 00 118 93 72 80 107 73 30 02 27 12 18 15 119 95 75 79 108 76 31 02 27 12 18 30 The highlighted values are measurement values exceeding the specified limit values To enter measurement notes 1 Click onto the required line in the Notes column 2 Enter your note 3 Press the Enter key Excluding measurements If any outlier measurement value that would falsify a representative long term analysis it can be exclu
20. Hypertension Management Software HMS 5 0 Trends PWA 200 250 195 02 27M2 y 245 190 240 185 4 235 180 4 230 175 225 170 4 220 165 J 215 160 4 210 155 4 205 150 4 200 145 195 140 4 190 135 t185 130 4 180 125 4 175 120 170 B 15 165 E 110 160 105 155 I D 100 150 Y 2 95 145 2 g 90 140 85 135 80 130 75 x 125 70 A i 120 65 A oe 115 60 j A 8 110 55 4 105 50 ay N A 100 45 95 90 t85 80 25 4 75 20 70 15 4 65 10 K oO 60 5 x x bA x x 55 cda A 15 16 17 18 19 20 21 2 23 o m 02 03 04 05 06 07 08 09 10 e Axis selection Total vascular resistance Alx 75 co cBP Hr Hr Directions for Use PWA License WelchAllyn Advancing Frontline Care 2 2014 Welch Allyn Inc To support the intended use of the product described in this publication the purchaser of the product is permitted to copy this publication for internal distribution only from the media provided by Welch Allyn Caution Federal US law restricts sale of the device identified in this manual to or on the order of licensed physicians Welch Allyn does not accept liability for injuries or unlawful or improper use of the product which may result from the fact that the product is not used in accordance with the instructions cautions and warnings as well as the indications for use published in this manual Welch Allyn is a registered trademark of Welch Allyn Inc
21. S 5 0 Welch Allyn E Database A Pje Language Port settings Blood pressure limits Analysis Colors Format PWA CBP Activation GDT settings 14 First steps with the sample patient 3 Click Yes Do you wish to activate a PWA CBP license 4 The HMS will then prompt the user to enter the 16 digit license key Enter the 16 digit license key and click Send 5 rc Coe O O oo 5 Click OK to confirm You successfully activated the following license ABPM7100 PVVA First steps with the sample patient Once you have successfully installed the HMS software the HMS may be tested with the sample patient John Doe Displaying the patient 1 Start the HMS by double clicking the hd icon located on the computer desktop The application window will appear 2 Inthe toolbar click the Patient List La icon to display the following window x Patient List LastName amp Firstname Patient ID Date of birth Last ABPM Doe John 999999999999999 08 02 45 071713 Open patient yA New patient 15 First steps with the sample patient 3 Select the John Doe entry and the click Open patient Tip Double click on the patient you selected and the application window will display the patient information sa HMS 5 0 Welch Allyn M o File Patient Measurementseries Settings P el e a 9 Gj Patient John poe 0810248 Welch Allyn Patient information Blood Pressure Pulse wave analysis
22. ame or patient ID in the search field at the top right The HMS will search the database and display the detected patients 2 Click to select the appropriate entry and the click Open patient 3 The HMS returns to the application window If the required patient cannot be found click New patient to create a new patient entry Modifying patient data To modify an address and or patient data enter the new information in the respective fields 1 To add Emergency contacts Medical history and Medication click New entry 2 Enter the new information into the respective popup window 3 Click Save to save the new data 4 The window closes Changing the Patient ID 1 In the menu bar click Patient then Change ID to display the following window with the current patient s ID shown 2 Change the patient s ID 3 Click Save to save the change Blood pressure limits 1 Inthe Patient Information tab click on the field Blood pressure limits 2 Specify the blood pressure limits for the current selected patient in the open editing window lf any measurement results exceed the limit values the respective results will be marked accordingly in the analysis Deleting a patient 1 Inthe menu bar click Patient then Delete 2 Click Yes to confirm 3 The current selected patient s information is deleted together with all measurement data Audit Trail In the menu bar click File and then Audit trail to display all changes in the p
23. ary Total Day Night Value Goal Value Goal Value Goal Time Start 05 29 2012 12 18 06 18 23 52 End 05 30 2012 11 00 23 51 06 17 Duration 22 42 16 16 06 26 Measurements Total 47 34 13 Valid 47 34 13 Valid 100 gt 70 100 100 Average Over single measurements Systole mmHg 141 lt 130 147 lt 135 125 lt 120 Diastole mmHg 99 lt 80 104 lt 85 84 lt 75 Pulse pressure mmHg 42 43 lt 60 42 Maximum Systole mmHg 172 18 00 172 18 00 131 06 00 Diastole mmHg 131 18 00 131 18 00 90 03 00 Heart rate bpm 88 07 30 115 21 08 80 01 00 Minimum Systole mmHg 120 02 30 128 12 30 120 02 30 Diastole mmHg 78 03 30 91 2330 78 03 30 Heart rate bpm 68 16 30 67 04 30 68 05 00 With Average the patient s average values and target values are displayed The blood pressure limits set for this patient are used as the target value Note The blood pressure limits can be specified in the Patient Information tab in the Blood pressure limits section With Day Night Decrease the percentage in decrease of the average blood pressure values average values between day and night is shown Printing the summary Click the Print 37 Analyzing the measurement The Hourly Intervals tab Displaying hourly average values This analysis lists all hourly average blood pressure and pulse values in table form To display the hourly average values clic
24. atient master data 19 Working with the ABPM 7100 i wa Audit trail Patient Object v Field Patient Time Object Field Value 11 19 2014 09 58 Created lEMPatient _ lid 2 11 19 2014 09 58 Created lEMPatient weight_si__ 0 0 11 19 2014 09 58 Created lEMPatient__ size_si 10 0 11 19 2014 09 58 Created lEMPatient birthdate 01 01 1990 11 19 2014 09 58 _ Created _ lEMPatient patientiD 1 11 19 2014 09 58 Created Adresse id 2 11 19 2014 09 58 Created Adresse llastname Patient 11 19 2014 09 58 Created Adresse firstname Test Working with the ABPM 7100 Pairing via cable Before 24 hour measurement When using the ABPM 7100 with cable connection perform the following steps Pairing the computer to the ABPM 7100 via the USB interface cable On the ABPM 7100 1 Ensure that the ABPM 7100 is powered off 2 Insert the USB interface cable into the computer s USB port 3 Insert the USB interface cable plug into the data port at the bottom of the ABPM 7100 Note The red dot on the plug must align with the red dot on the data port 4 Switch on the ABPM 7100 The letters co will appear on the display Configuring the interface between the ABPM 7100 and the HMS Setup conditions e The ABPM 7100 is connected to the computer e Both the ABPM 7100 and the computer are switched on On the computer 1 Start the HMS If t
25. chart 02 272 D NN WwW WwW un y gt s o wo o oO JA 1 a Bab nea A a on ean 0 mS B pa 4 4 4 4 4 4 4 4 4 4 4 4 4 1 4 4 1 4 4 4 4 w o AR Sn E A O MR RA a ete A Tt o w AM Onn I OOO WO CO B i O T Blood Pressure mmHg v yv e The left y axis with the unit mmHg applies to the systolic diastolic and average values blood pressure values e The right y axis with the unit bpm applies the heart rate e The x axis applies to the daytime The four adjustable daytime intervals for measurements are highlighted Manual measurements are marked with M e The upper blood pressure limits systolic diastolic are displayed as horizontal set point curves Note The blood pressure limits can be specified in the Patient Information tab in the Blood Pressure Limits section Zooming into enlarging the diagram Click onto the diagram and hold down the left mouse button and drag from the left to right to draw an enlargement section 34 Analyzing the measurement Zooming out restore original size of the diagram Click onto the diagram and hold down the left mouse button and drag from the right to left to restore back to the original size The Scatter Points tab This diagram shows the correlation between
26. ded Click onto the number of the respective column The measurement disappears and the measurement value will be excluded from statistical analysis To include the measurement values just click on the line again Printing the table of measurements Click the Print The Trends tab These measurement values are graphically displayed in a diagram as a function of time e Systolic values e Average Values e Diastolic Values e Heart rate 32 Analyzing the measurement To display the measurement values click on the Trends tab E w E hk amp amp e amp Trends 200 250 195 02127M2 p 245 240 235 230 225 L 220 Lars 210 205 200 195 190 L185 L180 L175 170 L165 L160 155 L450 145 140 L135 130 125 pa 115 L110 is 100 Los 90 Las 80 70 Les 10 jy K Oo ls 2i x x y x x e VAT AA AA AA AS A A A A a a IA ee Hr MAP Hourly Intervals y C Voltage Blood Pressure mmHg udg 4H e The left y axis with the unit mmHg applies to the systolic diastolic and average values blood pressure values e The right y axis with the unit bpm applies the heart rate e The x axis applies to the daytime The four adjustable daytime intervals for measurements are highlighted Manual measurements are marked with M e The upper blood pressure limits systolic diastolic are displayed as horizontal set point curves Note The blood pressure limits can be specified in
27. e adjusted individually Additionally protocol 10 automatically sends measurement values to the doctor s computer via Bluetooth after measurement It is recommended to use protocol 10 for monitoring at the doctor s office Additionally protocol 11 activates the Pulse Wave Analysis PWA Selecting the protocol 1 In the protocol drop down menu click on the required protocol 2 For protocols 1 2 10 and 11 under daytime and nighttime interval determine the following e The time frame start of interval e The number of measurements within the interval e Whether the measurement values are displayed on the ABPM 7100 measurement display value e Whether an audible signal buzzer sounds during measurement Sending the protocol 1 Click Send and activate 2 Click Yes to confirm Setting the ABPM 7100 clock The computer s time will be adopted by the ABPM 7100 1 Click Set clock on device 2 Click Ok to confirm and the ABPM 7100 displays the adopted time Transmitting the Patient ID The patient ID of the selected patient should be saved in the ABPM 7100 When the 24 hour measurement values are transferred the HMS will automatically recognize the patient 1 Click Send Patient ID 2 Click Ok to confirm Testing the ABPM 7100 Perform the following steps to ensure that the ABPM 7100 is fully functional 1 Click Testing Device to display the following window 28 Preparing the ABPM 7100 for measurement Testin
28. e application from CD ROM B Insert the USB adapter and or the Bluetooth adapter into the computer Installing the application from CD ROM 1 Place the provided CD into your CD ROM drive The Desktop will display the CD symbol for HMS 2 Double click on this CD symbol for HMS CD ROM will open Open the directory Mac_10 7 5 4 Move the file HMS app to your program directory 10 Installing the software Installation for Linux Procedure A B Installing the application from CD ROM Insert the USB adapter and or the Bluetooth adapter into the computer Installing the application from CD ROM 1 o u N Log on as system administrator root Place the provided CD into your CD ROM drive Open the directory Linux on the CD Copy the folder HMS into the Home Directory Set the file HMS as executable in the Home Directory Create a desktop shortcut to the file HMS Installing the Bluetooth driver No driver is required for the Bluetooth USB adapter DIGITUS applicable from Windows XP SP2 and above Installing the USB driver 1 HMS Installation WelchAllyn Hypertension Management Software A Before plug in USB cable Please install USB Cable driver zJ HMS Setup Installation of HMS a Es O Documents Manual Short Guide etc iM d SS USB Cable driver Not for Windows 95 NT Main Menu G7 Exit Quit installation In the installation menu click USB Cable Driver 2 Follow
29. e device click Save The window disappears and the new device is displayed in the port settings list Performing a connectivity test for Serial USB interface 1 Click the interface of the ABPM 7100 you want to test 2 Click Connectivity test and the following window appears with the result of the connectivity test Test successful If connection to the measurement device was not successful a respective message will appear Specifying a Bluetooth interface for the ABPM 7100 1 Click the Bluetooth tab 2 In the Bluetooth tab click Add device The following instruction will appear Switch on the ABPM 7100 and change to pairing mode 3 Switch on the ABPM 7100 and change into PAlr mode refer to Connection via Bluetooth 4 Click OK The Searching for Bluetooth Devices window appears and after a moment the device serial number will appear in the window 51015 Click to select the serial number Click Pairing The following message appears Pairing successful Click OK Click Save The new device will be listed on the Interfaces window of the Bluetooth tab E E Deleting the ABPM 7100 from the list 1 Click on the ABPM 7100 to be deleted 2 Click Delete device 3 Click Ok to confirm and the device serial number will be deleted from the list Saving the interface To accept the modification click on Save and the Port settings window closes Blood pressure limits You can specify global limit
30. e specified in the Patient Information tab in the Blood pressure limits section Displaying individual values In the diagram click the desired time A vertical line appears and the measurement values are displayed in a window To see adjacent measurement values move the mouse over the diagram The vertical line follows the movement of the mouse and the respective values are displayed Click again to deactivate the display Zooming into enlarging the diagram Click onto the diagram and hold down the left mouse button and drag from the left to right to draw an enlargement section Zooming out restore original size of the diagram Click onto the diagram and hold down the left mouse button and drag from the right to left to restore back to the original size 39 Analyzing the measurement The Trends PWA tab This analysis shows you the course of the PWA over 24 hours with a preset protocol 11 These following values are graphically displayed in a diagram as a function of time in the measurement series in addition to the blood pressure values and the pulse Central blood pressure Aix 75 90 Cl Cardiac output HMV and Peripheral resistance 1 To display the course of the above mentioned values click on the Trends PWA tab 1957 02 2712 245 Blood Pressure mmHg 11 12 aji 14 15 16 17 18 19 20 21 22 23 00 01 02 03 04 05 06 07 08 og 10 Axis selection Total vascular resistance Alx 75 co cBP Hr I sd
31. ed at the preset intervals After which a PWA is additionally performed with the ABPM 7100 reinflates to record the pulses at diastolic pressure Transferring and analyzing 24 hour PWA measurement results For transferring and analyzing of the 24 hour PWA measurement results perform the same steps as with the regular 24 hour ABPM Displaying the PWA The following analysis appears automatically after a successful completed PWA wa HMS 5 0 Welch Allyn File Patient Measurementseries Settings 2 E g af J Patient John Doe 08 02 45 WelchAllyn Patient information Blood Pressure Pulse wave analysis 9 Office measurement PWA CBP ba be A L L ei 02 05 12 02 20 12 Pulse wave analysis Peripheral pulse wave measured 03 10 12 11 10 12 11 20 14 11 20 14 9 24h PWAICBP PWA 1 EE EJE BWE Measurement Date 11 20 2014 Time 10 08 Blood pressure o 02 27 12 Systole mmHg 134 Central pulse wave calculated a are 90 135 MAP mmHg 110 Pulse pressure mmHg 44 120 Heart rate 1 min 61 cSys mmHg 124 cDia mmHg 91 cPP mmHg 33 Pulse pressure amplification 1 33 Hemodynamic Stroke volume ml 95 99 Cardiac output l min 5 9 Total vascular resistance s mmHg ml 1 13 Cardiac index l min 1 m 2 9 Arterial Stiffness Augmentation pressure mmHg 4 Reflection Magnitude 56 Augmentation Index 75 90 Cl 3 17 38 PWV 90 Cl m s 10 3 8 7 10 2 V
32. elocity PWV Performing PWA at the doctor s office Pulse wave analysis is performed at the doctor s office via the Bluetooth interface of the ABPM 7100 1 2 3 Note Position the cuff on the patient and connect the cuff to the ABPM 7100 Switch on the ABPM 7100 Select an existing patient or create a new patient in the HMS By default the PWA measurement is always assigned to the current patient on the screen The patient s age height and weight must be entered into the HMS prior to perform PWA measurement Connect the ABPM 7100 to the HMS via Bluetooth Attention a A PA s Jl _ Action of device 1 Upload values PWA Measurement Cancel Then select PWA Measurement to call up the PWA measurement window Set cuff in place sitting First measurement 30 second pause Blood Pressure PWA Height cm Weight kg Peripheral pulse wave measured 44 Pulse Wave Analysis PWA 6 Click OK to start the measurement 7 Click Save once all measurement steps associated with PWA have been successfully completed Performing 24 hour PWA In order to perform 24 hour PWA the ABPM 7100 must be upgraded with a valid PWA license key and the HMS software version must either be 5 0 and above When preparing the ABPM 7100 to perform a 24 hour PWA measurement select protocol 11 Once the ABPM 7100 is prepared with protocol 11 regular blood pressure measurement is perform
33. ent data from measurement device Note Normally the measurement results from the ABPM 7100 are deleted once the results are transferred When preparing the ABPM 7100 for a new patient the HMS will indicate any existing measurement results remaining in the ABPM 7100 from a previous patient 10 Click Yes to delete the measurements results or click No to keep the measurement results on the ABPM 7100 The Measurement Series window appears 26 Preparing the ABPM 7100 for measurement Measurement series Please choose the starting times of the Day Night intervals or type them in manually HH mm Start of daytime interval 07 00 Ly The Day Night key was not pressed HH mm Start night interval 22 00 w Day Night button has been pressed 1 times Findings Notes Protocol Transmission Serial number 11 03 02 2012 C08215 Save Cancel 11 If necessary change the times for the daytime and night interval 12 Enter a note 13 Click Save to confirm and the transmitted measurement values are displayed as a table of measurements On the ABPM 7100 14 The buzzer sounds 15 The letters bt End appear on the display followed by the time 16 Switch off the ABPM 7100 For further measurement series analyzes refer to the chapter on Analyzing Measurements Preparing the ABPM 7100 for measurement Before performing a measurement on a patient send via the HMS the information on the
34. escriptions on the analysis options are detailed in the Analyzing the measurement chapter Editing patient information Patient information is stored in a database You can e create new patients e edit patients data by clicking onto the respective field e import already available patient information from other databases Note Patient information can always be edited once it has been created Creating new patients In the toolbar click the New piene 2 icon to display the following window x Patient ID 1 Address Last Name First name Patient data Height cm Weight kg BMI Smoker mmiddyyyy Age ee Patient ID Last Name and Date of birth are mandatory fields these information serve as criteria for sorting or searching all other information are optional Tip Use the tab key to jump from one field to the next 17 Editing patient information To save the new patient click Save To discard the new patient click Cancel Either option will return back to the application window v HMS 50 Welch Alyn I te File Patient Measurementseries Settings a Y LA EY amp ag Patient Test Patient 01 01 90 WelchAllyn Patient information Blood Pressure Pulse wave analysis Address Medical history Laat Neen Fini amne From To Disease Notes Patient Test Street Address 2 Zip
35. f measurements Department Room 135 85 mmHg Emergency contacts Last Name First name Phone Relationship newentry new entry Functions can be called up from the menu bar at the top of the window The toolbar below the menu bar contains buttons icons for the individual processing steps The main working area contains three tabs 1 Patient information 2 Blood Pressure 3 Pulse wave analysis Menu bar The menu bar is located at the top of the application window File Patient Measurement series Settings 12 Structure of the HMS application window Below shows the functions summary for each item File menu Patient list Display a list with previously created patients New patient Create a new patient Back up data Database back up and recovery Attention During recovery the current database is replaced by the backed up database risk of possible data loss Audit trail Record all changes to patient data Quit program Exits HMS Patient menu CTC O Measurement Series menu Menwitem Fame OOS Expor os Expo XML Expo GOT Settings menu Database Configure the database Language Specify the language for the program Port settings Specify the port to the measurement device Blood pressure limits Specify limit values for analysis Analysis Specify the settings for the analysis Colors Specify colors for curves and diagram backgrounds Format Specify calculation display and B
36. g Device Det internal battery Keypad pA status C 2 Click on the appropriate function keys 3 Click Ok to confirm 4 Click Close to complete the testing Deleting old measurements The measurement results in the ABPM 7100 are usually deleted once they have been transferred to the computer When preparing the ABPM 7100 for a new patient the HMS will indicate any existing measurement results remaining in the ABPM 7100 from a previous patient To remove existing measurement results in the ABPM 7100 1 Click Delete measurements 2 Click Yes to confirm Completing ABPM 7100 preparation 1 Click Close and the Prepare device window disappears 2 Disconnect the ABPM 7100 from the computer Exporting measurement results Measurement results from a 24 hour measurement which has been transferred from the ABPM 7100 to the HMS for analysis can be stored in a file With the help of this file there is the option to transfer the measurement results into your patient management system 1 Select a patient 2 Inthe application window click on the Blood Pressure or Pulse wave analysis tab 3 These tabs contain a list of previous measurements on the left wa HMS 5 0 Welch Allyn J a File Patient Measurement series Settings Export Excel 7 E 2 Y ES 15 ag Patient John Doe osoza5 WelchAllyn Patient infory XPOTt GDT Fessure Pulse wave
37. he HMS is set appropriately the Patient List window will appear In this case select a patient 2 Inthe menu bar click Settings and then Port settings 3 Inthe Port settings window click the Serial USB tab Preparing the ABPM 7100 for 24 hour measurement Setup conditions e The ABPM 7100 is connected to the computer e Both the ABPM 7100 and the computer are switched on 20 Working with the ABPM 7100 Note Always use fully charged batteries for a new measurement Ensure the correct polarity when inserting the batteries On the computer 1 Start the HMS 2 Select a patient gt 3 Inthe toolbar click the Prepare device icon to display the following window Prepare device Version 20 Eo W Patient Send Patient ID Set clock on device John Doe Aug 2 1945 999999999999999 Delete measurements Testing Device Protocol Protocol 10 y Send and activate Preset v lv Display of measured values lv Bluetooth active lv PWA 1st daytime interval 2nd daytime interval 3rd daytime interval Night interval Start 8 y lock Start aoje lock Start 13 v lock Start o lock Measurement 30 Measurement 30 h Measurement 30 h Measurement 30 Buzzer Buzzer Buzzer Buzzer Na Open patient Close Note If the battery voltage in the measurement device is insufficient for a 24 hour measurement the following warning will appear Attention AN The minimum battery
38. ion Serial number 11 03 02 2012 C08215 Y Save 7 f necessary change the times for the daytime and night interval 8 Enter a note 9 Click Save to confirm and the transmitted measurement values are displayed as a table of measurements On the ABPM 7100 10 Switch off the ABPM 7100 11 Disconnect the USB interface cable remove the plug from the data port For further measurement series analyzes refer to the chapter on Analyzing Measurements Pairing via Bluetooth Before 24 hour measurement Please perform the following steps when using the ABPM 7100 with Bluetooth connection Configuring the interface between ABPM 7100 and HMS To configure the interface between ABPM 7100 and HMS ensure the computer is switched on and the Bluetooth driver is installed CA For further information on your ABPM 7100 please refer to the directions for use of the ABPM 7100 On the computer 1 Start the HMS If the HMS is set appropriately the Patient List window will appear In this case select a patient 2 Inthe menu bar click Settings and then Port settings In the Port settings window click the Bluetooth tab 4 Click Add device The following instruction appears Switch on the ABPM 7100 and change into PAIr mode o 23 Working with the ABPM 7100 On the ABPM 7100 5 Switch on the ABPM 7100 6 Switch the ABPM 7100 into Pairing mode i Press and hold O and then press ca Il Keep O pres
39. ital statistics Height cm 180 Weight kg 82 Body Mass Index BMI kg m 25 3 Body surface area m 2 0 msec 2 Report Ejection wave Reflection wave From 10 pulse wave measurements a filtered and average pulse wave is determined and in turn used to calculate the central aortic pulse wave The Augmentation Index Alx is repeatedly cited in medical literature as dependent on gender age and heart rate This is why the use of a standardized display in accordance with these parameters is preferred The Augmentation Index is initially normalized to a heart rate of 75 1 min with the help of an empirically determined regression This parameter is then known as Alx 75 If one were to examine a representative cross section of the population as described in the result would be an age dependent estimate for the Aix 75 plus an associated confidence interval These pertinent studies have also revealed a significant difference in the average Aix 75 between men and women Based on several internal researches with an independently ascertained cross section of the population size of about 2000 people the average values displayed below with 90 confidence intervals were determined 45 Changing the default settings of the HMS As with the previously discussed case studies the independently ascertained measurements revealed an increase in the Aix up to the age of 55 years Both genders then
40. k on the Hourly Intervals tab MAX Ss i i i tt i fe DB pa hsm Jeli p TA TA Ble qa pi oe a o mm ee gle ele e Hourly Intervals Time Systole Std Dev Diastole Std Dev Hear rate Std Dev Number 0 1h 12 i 3 4 2 1 2h 128 1 0 86 2 5 80 0 5 2 2 3h 122 25 86 2 0 76 3 5 2 3 4h 125 3 0 84 6 0 74 0 5 2 4 5h 124 3 0 83 1 0 76 15 2 5 6h 123 0 0 80 0 5 69 1 0 2 6 7h 138 6 5 91 3 0 79 3 0 2 7 8h 156 2 5 110 7 0 85 3 0 2 8 9h 156 7 0 116 12 0 84 1 5 2 9 10h 146 2 0 104 1 5 82 5 0 2 10 11h 150 2 0 106 4 0 78 1 5 2 11 12h 144 0 0 98 0 0 81 0 0 1 12 13h 136 8 0 104 4 0 74 1 5 2 13 14h 144 10 5 107 5 0 72 2 0 2 14 15h 142 0 0 100 2 5 73 1 0 2 15 16h 150 5 0 108 3 5 74 45 2 16 17h 144 1 5 102 3 5 70 2 0 2 17 18h 146 8 5 101 7 0 75 3 0 2 18 19h 169 3 0 128 3 5 76 1 5 2 19 20h 152 4 0 108 6 0 77 1 0 2 20 21h 147 5 0 101 7 0 80 2 5 2 21 22h 144 0 5 98 0 5 76 25 2 22 23h_ 140 2 0 _ 92 0 5 72 1 0 2 23 24h 134 1 0 92 1 5 70 1 5 2 Base of mean value h 1 x Editing the calculation basis for hourly intervals Click the required hours 1 2 3 4 6 8 in the drop down field Base of mean value h Time intervals are displayed in the left Time column The average hourly value is recalculated Printing hourly intervals Click the Print tab The Rise and Fall tab This analysis is used to monitor the increase in morning
41. l requirements of Manufacturer European Medical Device Directive 93 42 EEC Introduction Preliminary note The Hypertension Management Software HMS serves to analyze the measurements taken by the blood pressure monitor ABPM 7100 from Welch Allyn With the help of the HMS measurement results can be transferred out for analyzes via a USB interface cable or via Bluetooth Measurement values can be displayed in various diagrams and other display formats then processed further or printed out The upgrade to the PWA License provides you with the additional option of a pulse wave analysis PWA About this directions for use This direction for use provides you with extensive information on the individual options of analyzing the measurement values from your ABPM 7100 Safety relevant information Safety relevant information is contained in the directions for use of the ABPM 7100 Ambulatory Blood Pressure Monitor Intended use The Hypertension Management Software is used in combination with the ABPM 7100 for the presentation and analyzes of blood pressure measurements The blood pressure curve of the ascending aorta is derived and a series of central arterial parameters are displayed It is used in those patients where information related to the ascending aortic blood pressure is desired but in the opinion of the physician the risk of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits CA Fo
42. luetooth procedures PWA CBP Activation Activate PWA Measurement PWA GDT settings Specify file and directory settings for GDT import export About menu MN Display information on the HMS version 13 Structure of the HMS application window Toolbar The toolbar is located below the menu bar at the top of the application window It contains buttons icons used to call up important functions quickly The current patient s name and date of birth are displayed on the right y EY y 3 gt Patient John Doe 080245 VelchAllyn Tip If you use the mouse to hover over a symbol a brief tooltip will appear E New patient Create a new patient Patient List Display a list with previously created patients Prepare device Prepare the ABPM 7100 for the next measurement Upload device Transfer out measurement values from the ABPM 7100 red Bluetooth not active Bluetooth Bin et green Bluetooth active Quit program Exits HMS Note You can also access some of these functions via the menu bar Activating Pulse Wave Analysis PWA Apart from the 24 hour blood pressure measurement the ABPM 7100 also has an integrated pulse wave analysis function PWA This function can only be unlocked after a device upgrade with a 16 digit license key that is unique to the ABPM 7100 device serial number Please consult Welch Allyn on device upgrading 1 Start the HMS 2 Inthe Settings menu click PWA CBP Activation wa HM
43. lyn specialist 46 Changing the default settings of the HMS 1 Inthe menu bar click Settings then Database The Database window appears Database Database configuration H2 Standalone 2 Enter the required information 3 Click Save Changing the language The user interface is available in various languages 1 Inthe menu bar click Settings then Language to display the Language window Language After changing the language the program must be restarted Language Auto save Cancel 2 Select the required language from the drop down field 3 Once the modifications are completed click Save to close the window Note For the new language to take effect exit and restart the HMS Port settings The interface to the following connections between the ABPM 7100 to the computer can be specified here e Cable with USB interface e Bluetooth In the menu bar click Settings then Port settings to display the Port settings window Specifying a serial USB interface for the ABPM 7100 1 Click the Serial USB tab 2 Click Add device to display the Connection to the device window Connection to the device Interface Type Bm 3 To search for a device switch on the ABPM 7100 4 Click Search Detected devices will be displayed in the drop down list If no device is selected a respective message will appear 47 Changing the default settings of the HMS 5 To add th
44. ngs then Format to display the following window Export file name Export file name Over single measurements Date of measurement Mean arterial pressure Measured MAP Time of measurement After transmission of messurements Initials Display of measurements Patient ID _ Show patient list after program starts Type of measurement Bluetooth active Combine SBPM Measurements Length wnit cm Weight unit CRE Date format E 1995 05 31 7 Resist unit s mmHai mi Time format Z av a wd 2 Specify the required settings 3 Once the modifications are completed click Save and the window closes GDT settings Device Data Transfer Geratedatentransfer is a data exchange format used by private practices in the German healthcare system The GDT interface serves system independent data transmission purposes between medical measurement devices and an office IT The GDT settings are required for the automatic exchange of patient data between your office IT and HMS If the settings are correct the HMS can be started from your office software and patient data can be accepted directly In the menu bar click on Settings then GDT Settings The GDT Settings window appears GDT exchange directory C Program Files HMS_WA Selection PMS gt HMS file GDT lEXPORT GDT HMS gt PMS file GDT IMPORT GDT O se 51 Changing the default settings of the HMS Click Selection
45. nt series is transferred directly via Bluetooth to a computer at the doctors office Each measurement can be analyzed by the doctor immediately You can use the office monitoring to subject the patient to a narrow short term control scan Attention The system does not claim to have alarm functions Preparing the ABPM 7100 for monitoring at the doctor s office For office monitoring the Bluetooth interface of the ABPM 7100 must be used 42 Monitoring at the doctor s office Send Patient ID Set clock on device John Doe Aug 2 1945 sesssessssessss Delete measurements Testing Deuce reed T Display of measured values Bluetooth active PWA 1st daytime interval 2nd daytime interval 3rd daytime interval Night interval Start 8 v Clock Start 10 w Clock Start 113 w Clock Start 0 w Clock Measurements 30 w Measurements 30 w Measurements 30 w Measurements 30 w Buzzer Buzzer Buzzer Buzzer Open patient Close Select Protocol 10 for office monitoring Select Time Interval 30 20 15 12 measurements per hour For further information on the ABPM 7100 please refer to the directions for use of the ABPM 7100 Attach the ABPM 7100 on the patient Position the cuff and connect it to the ABPM 7100 Tick Bluetooth active To ensure that the ABPM 7100 works as required press il to start a manual measurement A successful measurement is required for protocol activation Wait fo
46. or provisions of Cyber Security the following should be observed for the safety of the HMS software Do not activate a guest account on the computer Use the database export function for regular backups The HMS does not provide automatic backups Regularly update your operating system firewall and antivirus software Do not use Operating Systems for which support has been discontinued Ensure that only authorized personnel have access to your computer System requirements ie Computer e 1GHz e 512 MB RAM e 100 MB Hard Disk Storage e 1024 x 768 Pixels e Two spare USB Ports Operating System e Windows Vista Windows 7 Windows 8 Windows 8 1 32 bit amp 64 bit e Macintosh OS X 10 7 5 and above 64 bit e Linux Ubuntu 14 04 and above 64 bit Software e Java Runtime Environment JRE is contained on the installation CD Bluetooth e Bluetooth USB adapter e Bluetooth 2 0 e USB version 1 1 and above e BlueSoleil driver or software must not be installed 8 Installing the software Installation for Windows EEX The directions for use are located in the docs folder on the installation CD Available documents are clearly displayed via index htm Procedure The individual steps are explained in more detail below A Installing the HMS from CD B If required install drivers from the CD in the following sequence 1 Bluetooth driver 2 USB driver C Insert the USB interface cable and or the Blue
47. r further information on your ABPM 7100 please refer to the directions for use of the ABPM 7100 6 Working with HMS Description of the HMS The ABPM 7100 measures blood pressure and stores the measurement Upon completion of the measurements the stored measurements can be transferred to your computer where measurements can be analyzed with the HMS according to your convenience The patient file contains data such as e Patient ID mandatory input e Name mandatory input e Contact information address telephone number emergency contacts etc e Personal data age gender etc e Medication Medical history Blood pressure limits The HMS offers you various analysis options Results can be displayed on the computer screen or printed Out e Display all individual measurements e Statistical analysis with mean blood pressure values for the entire day daytime and nighttime first hour upon initial measurement as well as mean hourly values e Extreme values maximum minimum e Frequency percentage of measurement values above a specified limit value e Calculation of daytime nocturnal decrease e Deviation from standards variability Graphical analyzes e Envelope curve of mean hourly values Correlation Pie chart of exceeded limits in percent Bar chart of measurements Curve of changes in blood pressure Curve of measurement values Histogram of blood pressure distribution Curve comparison for treatment optimization In
48. r the first automatic measurement to be completed Assigning received measurement results 1 2 f After the first measurement the icon will appear in the toolbar Click on this icon The Office Monitoring window appears Serial number Patient ID Measurements Assignment Delete 11 20 2014 cSsT015 plas 999999999999 1 yj Click on assign The Selection window appears o T Please choose a patient that the measurement series should be assigned to John Doe 08 02 45 Patient List Here you can assign the measurement results to either the current open patient or to another patient from the patient list 43 Pulse Wave Analysis PWA Pulse Wave Analysis PWA Apart from the 24 hour blood pressure measurement the HMS in connection with the ABPM 7100 also has an integrated pulse wave analysis system PWA This function can be unlocked with a valid PWA license key Please consult Welch Allyn on device upgrading The pulse wave analysis is based on the concept that the arterial blood pressure curve contains haemodynamic information that exceeds peripherally measured blood pressure values This is used to analyze all information on the central aortic pulse wave The following values are emitted Central blood pressure Central pulse pressure Augmentation pressure Augmentation Index Aix 75 90 confidence interval Cardiac output HMV Peripheral resistance Reflection coefficient Pulse Wave V
49. reached a plateau The difference in Aix levels between the genders is between 8 to 10 If measurement values exceed the gender and age specific interval further examinations in accordance with the European Treatment Guidelines for Hypertension are recommended in order to determine the reasons of the disorder female hina Ahk gTS 1 Wilkinson I B et al Heart Rate Dependency of Pulse Pressure Amplification and Arterial Stiffness American Journal of Hypertension 2002 15 24 30 2 Fantin F et al ls augmentation index a good measure of vascular stiffness in the elderly Age and Ageing 2007 36 43 48 3 The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension ESH and the European Society of Cardioprotocoly ESC 2007 Guidelines for the management of arterial hypertension European Heart Journal 2007 28 1462 1536 Changing the default settings of the HMS The following settings for the HMS can be specified e Analyzes Blood pressure limits Basis of calculation e User interface Language Colors Interfaces Database Bluetooth To change default settings of the HMS click Settings in the menu bar and select the required function Database Patient data and the associated measurement data are stored in a database Here you can specify the information for access to the database You can obtain further information from your Welch Al
50. revious measurements on the left 30 Analyzing the measurement 3 Click on a measurement to display the associated table of measurements s HMS 50 Wel Al AAA ma File Patient Measurementseries Settings 2 Y LA y amp ag Patient John doe 080249 WVelch Allyn a Blood Pressure Pulse wave analysis 9 Office BP Monitoring E few jai f pa 6 ik ie me bee E E we 08 11 12 Num Date Time sys MAP Dia Hr cSys cDia Code Notes a 0871212 24h ABPM 11 02 27 12 10 44 106 81 60 87 97 61 230 Starteinermanuellen Messung a at 02127712 CBP 2 o2r27m2 10 45 106 85 67 87 9 68 3 02 27112 11 00 100 78 60 5 so 61 ae 05 29 12 4 o2272 11 15 106 82 62 83 97 64 5 o2r27m2 1133 117 87 62 84 66 1211 la 06112112 6 ozr27m2 11 45 116 84 57 90 os 62 ae 06 13 12 7 ozra7ma 12 03 137 111 ss 89 8 9 02 27 12 12 15 120 93 70 84 109 72 02 27 12 12 30 102 81 64 79 92 65 10 02 27 12 12 48 118 90 68 89 11 02 27 12 13 00 118 87 60 76 111 62 42 02 27 12 13 15 102 78 58 76 94 59 13 02 27 12 13 30 99 76 57 75 91 58 14 02 27 12 13 45 99 78 60 76 92 61 15 02 2712 14 00 114 88 66 77 108 67 16 02 27 12 14 15 107 85 66 71 98 66 17 02 27 12 14 30 109 88 70 68 101 70 18 02 27 12 14 45 116 91 69 71 110 70 19 02 27 12 15 00 143 100 64 74 134 67 2
51. sed until the letters PAIr start flashing on the LCD display iii Press PAlr stops blinking and the buzzer sounds On the computer 7 Click OK The Bluetooth device search appears After a moment the serial number of the ABPM 7100 e g WSTXXX appears in the application window 8 Click the serial number 9 Click Pairing The following message appears Pairing successful 10 Click OK to confirm and the Device Connection window appears 11 Click Save On the ABPM 7100 12 The buzzer sounds On the computer 13 The measurement device appears in the Port settings window on the Bluetooth tab Click Save On the ABPM 7100 14 Switch off the ABPM 7100 The Bluetooth interface between the ABPM 7100 and the HMS is now configured From now on the HMS will recognize the ABPM 7100 as soon as the ABPM 7100 is in communication mode bt Preparing the ABPM 7100 for 24 hour measurement Ensure the ABPM 7100 is switched off and the computer is switched on The interface between ABPM 7100 and the HMS must already be configured GA For further information on your ABPM 7100 please refer to the directions for use of the ABPM 7100 On the ABPM 7100 1 Switch on the ABPM 7100 On the computer 2 Start the HMS 3 Inthe toolbar a green Bluetooth E icon signals the active Bluetooth connection 4 Select a patient On the ABPM 7100 5 Press and hold a and then press ED 6 Press a The letters
52. ss dl for manual measurement to ensure that the ABPM 7100 is functional 3 Wait for the first manual measurement to be completed lf the measurement is acceptable the patient can leave successful measurement is required for protocol activation 25 Working with the ABPM 7100 After 24 hour measurement Please perform the following steps when using the ABPM 7100 with Bluetooth connection 1 Ensure the ABPM 7100 is powered off 2 Remove the ABPM 7100 from the patient remove the cuff and disconnect the ABPM 7100 Transferring out 24 hour measurement results from the ABPM 7100 via Bluetooth Ensure both the ABPM 7100 and the computer are switched on The interface between ABPM 7100 and the HMS must already be configured On the computer 1 Start the HMS 2 Inthe toolbar a green Bluetooth E icon signals the active Bluetooth connection On the ABPM 7100 3 Press and hold and then press ED 4 Press GO The letters bt flash on the display 5 Press E bt stops flashing and the buzzer sounds The Device Action window appears On the computer 6 Click on Read out of values The HMS will prompt the user Assign measurement data to patient with patient ID XXX 7 Click Yes to confirm After data transmission the Measurement series window appears 8 If necessary change the times for the daytime and nighttime interval 9 Click Save The HMS will prompt the user Delete Patient ID and measurem
53. start interval for the four daytime intervals e Static beginning Start time of graphic displays e With or without Day Night button Settings for the start times of the four daytime intervals e Once the modifications are completed click Save and the window closes Specifying colors for curves and diagram backgrounds 1 Inthe menu bar click Settings then Colors to display the following window P B standard Background Iz BP night background O5 Battery voltage n F Blood pressure graph E r MAP curve Iz Ey MAP Fourier curve M Hr Colors BP area M BP limits H Average BP H Hl BP correlation daytime B Night time BP correlation H Hr Pulse rate curve M 2 To change the colors select the preferred color from the drop down field 3 Once the modifications are completed click Save and the window closes 50 Changing the default settings of the HMS Format Here you can specify standard procedures for Average calculation for all individual values or the hourly mean values HM Calculation of the mean arterial pressure measured MAP or calculated MAP The measurement value analysis to be displayed after the measurement data has been transmitted from the ABPM 7100 to the HMS table of measurements or graphics Whether the patient list or an empty application window is displayed after the program starts Whether Bluetooth is used In the menu bar click Setti
54. tab Comparing several measurement results Monitoring at the doctor s office Preparing the ABPM 7100 for monitoring at the doctor s office Assigning received measurement results Pulse Wave Analysis PWA Performing PWA at the doctor s office Performing 24 hour PWA Transferring and analyzing 24 hour PWA measurement results Displaying the PWA Changing the default settings of the HMS Database Changing the language Port settings Blood pressure limits Analysis Specifying colors for curves and diagram backgrounds Format GDT settings 27 27 27 28 28 28 29 31 31 33 34 34 35 36 37 37 39 40 40 41 41 41 42 43 43 44 44 44 45 45 46 46 47 49 49 50 50 5 Symbols Symbols The following signal words symbols and pictographs are used in this direction for use to indicate important information Attention The attention statement marks possible Note The note statement marks further material damage Non adherence may information on the HMS lead to damage to the device or its accessories Tip The tip statement marks a useful tip for Consult Directions for Use Electronic example a short key id version available at Welchallyn com walchallyn com Or Hard copy DFU available from Welch Allyn within 7 days INTERNAL REFERENCE Marks LLA EXTERNAL REFERENCE Marks references within the document to further references to external documents information containing further optional information C 4 q Meets essentia
55. ted values are measurement values exceeding the specified limit values 4 Todisplay additional analyzes click on the required analysis tab Enter the results of the measurement series 1 Double click on the measurement and the Measurement series window appears Please choose the starting times of the Day Night intervals or type them in manually HH mm Start of daytime interval 07 00 w The Day Night key was not pressed HH mm Start night interval 22 00 Day Night button has been pressed 1 times Findings Notes Transmission Serial number 03 02 2012 C08215 2 Enter your notes 3 Click Save to accept the notes and the Measurement series window disappears 31 Analyzing the measurement The Measurements tab The Measurements tab lists all measurement values of a measurement series in table format To display the table of measurements click on the Measurements tab fe fa pE ike gik ei e Measurements Num Date Time Sys MAP Dia Hr cSys cDia Code Notes 1 02 27 12 10 44 106 81 60 87 97 61 230 Start einer manuellen Messung 2 02 27 12 10 45 106 85 67 87 96 68 3 02 27 12 11 00 100 78 60 85 90 61 4 02 27 92 11 15 106 82 62 83 97 64 5 oze7n2 11 38 117 87 eel ss 6 02 27 12 11 45 116 84 57 90 95 62 E 02 27 12 12 03 137 111 88
56. the Patient Information tab in the Blood pressure limits section Showing and hiding the heart rate Click the option field Hr Showing and hiding average values Click the option field MAP Showing and hiding average values In the drop down field Hourly Intervals click the required number of hours Battery Voltage Select the option field Voltage The battery voltage is displayed as a 24 hour curve parallel to the blood pressure Displaying individual values 1 In the diagram click to select the desired time A vertical line appears and the measurement values are displayed in a window To see adjacent measurement values move the mouse over the diagram The vertical line follows the movement of the mouse and the respective values are displayed 2 Click again to deactivate the display 33 Analyzing the measurement Zooming into enlarging the diagram Click onto the diagram and hold down the left mouse button and drag from the left to right to draw an enlargement section Zooming out restore original size of the diagram Click onto the diagram and hold down the left mouse button and drag from the right to left to restore back to the original size The Bar Chart tab These measurement values are graphically displayed in a diagram as a function of time e Systolic values e Average Values e Diastolic Values e Heart rate To display the measurement values click on the Bar Chart alele eo li Ee mee ele a Bar
57. the instructions displayed on the screen 11 Starting and exiting the HMS Starting and exiting the HMS Starting the HMS Double click the Wa icon on the computer desktop to start the HMS Information on the loading progress e g program version progress bar is displayed Exiting the HMS Click the 4 icon on the application window top toolbar If any data have been previously changed the HMS will prompt the user if those changes should be saved Information on the quitting progress is displayed Structure of the HMS application window All functions can be accessed from the application window Depending on function additional windows may appear va HMS 5 0 Welch Allyn N e File Patient Settings PEARL Patent sonn ove 000245 Welch Allyn Patient information Blood Pressure Pulse wave analysis Address Medical history Last Name Fint nema From To Disease Notes Doe John Street Address 2 Baker Street Zip Code City Country 83445 London Phone ax numb Mobil 441234567389 e mail john doe com ow ont ry Patient data Blood pressure limits Medication Patient ID Server PID From To Trade name Active agent Dosage 999999999999999 ABPM Values i Pd aa Average Values leight cm Weight kg I Smoker Day 435185 mmHg 820 Night 120 75 mmHg Date of birth mm dd yyyy Age Gender Total 130 80 mmHg 08 02 1945 69 Male Single Values Day 140 90 mmHg Night 125 80 mmHg Sel
58. ther information on your ABPM 7100 please refer to the directions for use of the ABPM 7100 Transferring 24 hour measurement values out from the ABPM 7100 Ensure the ABPM 7100 is connected to the computer and both the ABPM 7100 and the computer are switched on On the computer 1 Start the HMS 2 In the toolbar click the Patient List t icon to display the Patient List window 3 Select a patient 4 In the toolbar click the Upload device su icon The HMS will prompt the user Assign measurement results to patient with patient ID XXX 5 Click Yes The HMS will prompt the user Delete Patient ID and measurement results from the ABPM 7100 Note Normally the measurement results from the ABPM 7100 are deleted once the results are transferred out When preparing the ABPM 7100 for a new patient the HMS will indicate any existing measurement results remaining in the ABPM 7100 from a previous patient 6 Click Yes to delete the measurements results or click No to keep the measurement results on the ABPM 7100 The Measurement series window appears 22 Working with the ABPM 7100 Measurement series Please choose the starting times of the Day Night intervals or type them in manually HH mm Start of daytime interval 07 00 w The Day Night key was not pressed HH mm Start night interval 22 00 Ly Day Night button has been pressed 1 times Findings Notes Protocol Transmiss
59. this way the course of and fluctuations in blood pressure over the day and night can be quickly and easily visualized Medication can then be adjusted base on the account of these changes Working with HMS Note Basic knowledge and experience in the Windows Mac OS X or Linux Operating System is required to use the HMS The HMS is used to administrate and analyze the measured blood pressure measurement data These measurement values are then assigned to the patient Each patient is not limited to one measurement series Each measurement series consists of numerous individual values In general the following steps are run through e Before measurement Preparing the measurement 1 Start the HMS Select existing patient or create new patient Pair the ABPM 7100 to the HMS Prepare the ABPM 7100 for measurement Exit the HMS Ol ee 7 Installing the software After measurement Process measurement data 1 Start the HMS Pair the ABPM 7100 to the HMS Transfer the measurement results from the ABPM 7100 Analyze the measurement results Exit the HMS Oe TS Installing the software The HMS is able to communicate with the ABPM 7100 via the following connections Note USB interface cable Bluetooth USB adapter Please insert only the Bluetooth USB adapter or USB interface cable into the computer after the HMS has been installed or when you are prompted to do so Provisions for Cyber Security Attention F
60. tooth adapter into the computer Installing the HMS from CD 1 Insert the CD into the CD drive 2 The HMS installation should start automatically If not please perform the following steps Open the CD drive in Windows Explorer Il Click on the file CD_Start exe to start the installation HMS Installation WelchAllyn Hypertension Management Software Installation Welvl Allyn on 1 a 0 J ee TARAI ga ED ait F j aa A ceoosa lt o 3 Select the installation language This launches the installation menu HMS Installation Welch Allyn Hypertension Management Software A Before plug in USB cable Please install USB Cable driver et zJ HMS Setup Installation of HMS a aia O Documents Manual Short Guide etc A E ee S Y S USB Cable driver Not for Windows 95 NT Main Menu cell Exit Quit installation 9 Installing the software nstallation wizard appears 4 Click on HMS Setup The i LO HMS WelchAllyn is preparing the install4j Wizard which will guide you through the rest of the setup process Please select a language English Ganas Welcome to the HMS WelchAllyn Setup Wizard This will install HMS WelchAllyn on your computer The wizard will lead you step by step through the installation Click Next to continue or Cancel to exit Setup Installation for Macintosh OS X 10 7 5 and above Procedure A Installing th
61. values for systolic and diastolic blood pressure If the limit values are exceeded the measurement results will be marked accordingly in the analysis Note These values are automatically saved as limit values for newly created patients 48 Changing the default settings of the HMS In general the blood pressure limit values established by World Health Organization WHO do NOT APPLY for children and adolescents between the ages of 3 to 18 years Current studies Blood Pressure percentiles by Age and Height from Nonoverweight Children and Adolescents in Germany Neuhauser et al Pediatrics accepted Dec 10 2010 have shown that the limits in children and adolescents are dependent on their age and gender In 2010 the European Society for Hypertension ESH published extensive tables Management of high blood pressure in children and adolescents recommendations of the European Society of Hypertension Lurbe et al Journal of hypertension accepted Jun 9 2009 on which the HMS limit values are based on The limit values are determined according to the 95 percentile curve The threshold is defined by the value which is equivalent or lower than 95 of a collective cohort statistical evaluation for 15 000 children Any value exceeding this limit is indicated as hypertension To have the percentile curve displayed for children and adolescents between the ages of 3 to 18 years the patient s date of birth must be entered from which the HMS will

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