INFUSCALE measures the accuracy of infusion pumps
Contents
1. pe DA AM SOA reci d eicit cc medie 23 5 2 DATA ACQUISIFION etri tele Gouna E eR OH BRE 24 3 21 Entering i oen era PCI FERES rt PERPE Ee eri ro 24 5 22 ControLof Data Transfer ett eB enor see dete ee ea ENS 23 2 249 26 5 24 Start Of measurement eia e e t aer ein 27 JA SEVEnUmAFKOE ame e ibo eb bre Rei bct m eite 30 5 2 6 Storage of Graphics on File and to Clipboard 30 5 3 SIMULATION eA ATR RA eee ARN ud 30 6 EVALUATION OF THE MEASURED DATA sssesessossesoessessossesessoesesoossesoesoesecsossessossesoessesoesoesessoesessessesose 31 6 1 THE TRUMPET CURVE e esi ee dived eel DI En an 33 6 1 1 Meaning of the Trumpet Curve according to EN 60601 2 24 33 6 1 2 Calculation of the Trumpet Curve according to EN 60601 2 24 50 102 sse 33 6 1 3 Calculation of the Trumpet Curve according to EN 60601 2 24 50 104 sse 35 6 1 4 Calculation of the Trumpet Curve according to EN 60601 2 24 50 105 sse 36 6 1 5 Calculation of an optional Trumpet 37 6 1 6 Modified Trumpet Curve and Constancy 38 6 17 Other COMMONS seh atitsi odes povero rede dread Bets 392. Setup and Help can be selected from here Please click on Setup now n Infuscale 7 0 Data Acquisition Evaluation Setup Help Picture 6 Main menue At the very first call of the Setup routine INFUSCALE tries to find an available serial port If a suitable port has been found the Setup screen appears Li Eats E ial B x baudrate Balances Print 1200 2400 Balances hp deskjet 990c series Mettler C 4800 9600 Mettler S 600 dpi data bits stop bits Ohaus abfr amp Ohaus GT C2 Chyo auto Precisa auto 5 parity COM Port kem Options C no com Custom auto V 0 Warning Odd come Log Check cows Preset values Equal C coma Pa 3 4 2 r Timer calibration auto wins 100 100 00 00 00 00 Start 5 Interval 5 0 Set 400 00 00 00 00 00 00 00 00 00 00 g Duration 4 Picture 7 Setup Screen If INFUSCALE has been installed on Windows 98 the checkbox M MWin98 must be marked In case of Windows NT 2000 XP or 7 this field remains empty At next the connected electronic balance is set by clicking on its name in the list Balances INFUSCALE 7 Instructions for use 16 A click on key Preset values selects the preset values Baudrate Data bits Stop bits and Parity of the highlighted bal ance according to the table in pic
3. which is in the limits of the acquired data The observation periods are 2 5 11 19 and 31 min utes The calculations are made according to section 102 of the standard however without re strictions regarding the minimum duration of measurement gt 2 hours The following input area opens immediately after clicking in which the user can enter the de sired time range for calculation 1 from Minute 186 E Clicking on El terminates the input and starts the evaluation INFUSCALE 7 Instructions for use 38 6 1 6 Modified Trumpet Curve and Constancy Index Short term accuracy is expressed by the concept of constancy index The principle is that the constancy index of the pump should be less than or equal to the half life of the drug used The data from which the constancy index is calculated are derived from the flow tests performed over 24 hours at 1ml h Flow is recorded at 30 second intervals over the final 18 hour period And the average rate is compared with flow over each observation window from 1 2 3 4 29 30 and 31 minutes The constancy index is the shortest time period during the pump s steady state operation over which measurement of output consistently falls within 10 of the mean rate The maximum positive and negative deviations of flow rate in each time window form the points of the modified trumpet curve In contrast to the classical trumpet curve according to EN 60601 2 24 this curve is based
4. 5 3 Simulation The option Simulation does not perform a real data acquisition It simulates the measuring by using an already existing INFUSCALE data file as data source instead of a balance It can be selected by clicking on Data acqusition and Simulation Data Acquisition Eve Simulation Exit The source file can be opened by clicking on the input area on the top left side The further op eration is identical to chapter 5 2 By marking the field 10 the speed of simulation can be increased 10 fold INFUSCALE 7 Instructions for use 31 6 Evaluation of the measured Data To evaluate the measured data please return to the main menu and click on Evaluation n Infuscale 7 0 Data Acquisition Evaluation Setup Help The following screen appears WfEvaluation E E e xl filename C unfuz 1e data Bsp2 pmp 28 Loadfile EH 60601 2 24 50 Technician Stat pumps 102 Amb pumps 1 104 Serial no Amb pumps 2 105 Disposable Set flow rate mih ds 105 Meas interv s Evaporation minh Density g ml Trumpet Curve of points Total time min Bolus evaluation L Picture 18 Screen Evaluation At this moment the keys on the right side can only be seen in outlines without a function How ever if an INFUSCALE file is loaded by clicking on their view changes to normal In the frame EN 60601 2 24 50 only those ke
5. 08 Dat Q tp ts ns ioo eee won discat nite a t enters Eee nene elg 40 INFUSCALE 7 Instructions for use 3 6 2 BOLUS BVALUATION Aii extet A ORE REEL E 44 6 2 1 Evaluation according to EN 60601 2 24 50 106 entente 44 6 2 2 Bolus Evaluation with adjustable Time 45 6 2 8 Other Commands Ea deo dae 46 6 2 4 Data Output e rn RU DER oaa praeced 48 7 MEASURING ACCURACY 52 7 1 EVAPORATION 3 nennen eic UI hip eps 52 7 2 INTERROGATION ERROR AERE 54 7 2 1 Mettler Balance AE100 Continuous Operation eee 54 7 2 2 Sartorius Balance MCI automatic data transmission esses esee eene enne enne nnn 55 7 2 8 Sartorius Balance MCI request mode cesses 56 8 SYMBOLS AND FORMULA eese eee tatu sosta suse essen snas tasa senatu 57 INFUSCALE 7 Instructions for use 4 Use of INFUSCALE It is not permitted to make copies or to sell Infuscale It is permissible however to make copies of the program disc to secure the data Liability We endeavour to supply a perfect product but we cannot guarantee a perfect running of the soft ware under all conditions Despite of an exact program validation we cannot guarantee the reac
6. HTML and CSV Storage of table as Excel data file INFUSCALE has been used since many years in testing a large number of different pumps with different attributes demonstrating that it is a reliable tool Data files stored with prior versions of INFUSCALE can be read and evaluated with the present version 1 1 Enhancements to version 6 5 Calculation of the modified trumpet curve and the constancy index Improved export to Microsoft Excel Improved entry of comments Improved setting of table print out parameters Storage of the name of the technician within the data file Optional operation of two balances on one PC INFUSCALE 7 Instructions for use 6 1 2 General Information on the Infusion Standard In recent years work has been done by a working group of the VDE and IEC International Elec trotechnical Committee on a new international standard for pumps and controllers This world wide recognised commission has completed the Norm IEC 601 2 24 Particular requirements for safety of infusion pumps and controllers First edition 1998 02 In the same year the standard has been harmonised according to the European Directive on Medical Devices 93 42 EEC as EN 60601 2 24 As the graphics described in the above mentioned standards have to be part of any user manual for infusion pumps a measuring system is necessary that the fulfils those requirements The main task of INFUSCALE is to perform together with the required har
7. TXT WMF HTML CSV RTF or XLS format A data transfer to Microsoft Word and Excel is easily possible INFUSCALE 7 Instructions for use 43 6 1 8 5 Storage of Graphics on File and to Clipboard When the cursors is pointing on a graphic a click on the right mouse key shows the following pop up menue CopyToJPG CopyT oClipboard Clicking the left mouse key on one of the menue items stores the graphic on data file in either BMP or JPG format or copies it to the clipboard from where it can be easily transferred to other programs e g Microsoft Word Note Auxiliary lines are not stored INFUSCALE 7 Instructions for use 44 6 2 Bolus Evaluation 6 2 1 Evaluation according to EN 60601 2 24 50 106 After clicking on key 106 the screen EVALUATION is called up which is suitable for the as sessment of pumps with bolus characteristics section 50 106 of the standard For this purpose weight and flow rate are simultaneously calculated and displayed In the following example the data file BSP6 PMQ has been loaded in screen EVALUATION before clicking on key 106 The following graphic appears 1815 s cC Weight DzDatenlNFUSCAL DATENTBSPS seid Weight Wifg Time range 0 185 min Time duration 185 min Measuring interval 10 sec 40 00 No of points 1111 Start weight 0 0000 g 30 00 End weight 44 7267 g min weight 0 0000 g 20 00 max weight 44 7267 Weight increase 44 7267 g 10 00 Increase of
8. Table Output After clicking on this key the file header the comment lines the single measured weight values and the calculated flow rate values are displayed in three tables At the end of table 3 the evalua tion results are shown Points 372 2 Index String Value ll index Comment 1 MESSINTERVALL SEC la 2 FOERDERRATE ML H 30 000 2 3 VERDUNSTUNG ML H 0 1200 3 4 DICHTE G ML 0 9980 4 5 NAME DER PUMPE Rollen SERIENNUMMER 12678 7 EINMALARTIKEL 8 TECHNIKER E S Index Time Time h m s Weight g Rate mln 96 Weight Rate 0 00 0 00000 0 00000 100 0 min 4 0 5 00 00 30 0 09000 10 94164 63 5 min 2 1 0 00 01 00 0 37000 33 78733 12 6 a 1 5 00 01 30 0 54000 20 56088 31 5 4 2 0 00 02 00 0 83000 34 98974 16 6 5 2 5 00 02 30 1 02000 22 96569 23 4 6 3 0 00 03 00 1 33000 37 39455 24 6 7 3 5 00 03 30 1 53000 24 16810 19 4 8 4 0 00 04 00 1 83000 36 19214 z0 6 8 4 5 00 04 30 2 08000 30 18012 0 6 10 5 0 00 05 00 2 34000 31 38253 4 6 11 5 5 00 05 30 2 63000 34 98974 16 6 12 6 0 00 06 00 2 84000 25 37050 15 4 ILI Row Column cell Picture 28 Table display Bolus evaluation You can scroll through the table by pressing the left mouse key and moving the
9. auto in the Setup screen and check the correspondence of the fixed pa rameters between computer and balance interface see chapter 3 2 4 3 Mettler Balances with SICS Serial Interface This section covers all balances of model types AB S AG AT AX MT MX PB S PG S PR SB SG SR UMT UMX The following table gives an overview of port connections to the PC Balance type Port PC Connection AB S RS 232C Cable AG LocalCAN Interface Box with cable AT RS 232C Cable AX RS 232C Cable MT RS 232C Cable MX RS 232C Cable RS 232C Cable RS 232C Cable LocalCAN Interface Box with cable RS 232C Cable LocalCAN Interface Box with cable LocalCAN Interface Box with cable RS 232C Cable RS 232C Cable Picture 4 Mettler balances with SICS Interface connection INFUSCALE 7 Instructions for use 13 Balances with RS 232C port are connected according to the following scheme Balance Pin 13 white gt Pin 5 of 9 pol PC Plug GND Balance Pin 12 brown Pin 2 of 9 pol PC Plug data from Balance Balance Pin 2 green Pin 3 of 9 pol PC Plug data to Balance Connect Pin 1 7 and 8 of 9 pol PC plug Picture 5 Connection scheme These balances can be operated in two different modes a continuous data transmission to the computer The settings in sector I FACE of the balance configuration register of the balance are Data output condition CONT Baudrate 2400 defau
10. computer and balances Accessories container cannula oil 2 2 Software installation Insert the program CD into the CD drive Start the software installation with Drive Setup E EXE in the run mode and press the OK key The installation routine transfers all program and data files from CD to the computer and creates an icon symbol on the desktop INFUSCALE 7 Instructions for use 9 2 3 Connecting the Balance to the PC The balance can be connected to any of the serial ports COMI to COMA of your computer The specific port is selected in the INFUSCALE setup procedure see chapter 3 As COMI is nor mally used for the mouse we recommend the selection of COM2 for connecting the balance We recommend to start without using handshake and the balance set to AUTO continuous mode The following lines must at least be connected between the balance and the specified COM port 1 GND 2 Data line Balance gt PC 3 Data line PC gt Balance It could happen that the connection of the data lines is initially incorrect and that no data appear on the computer screen In this case most often it is sufficient to cross the lines 2 and 3 Please check the settings of baudrate parity data bits and stopbits on balance and computer see chapter 3 Set the handshake option of the electronic balance to OFF and the transmission mode to con tinuous CONT or AUTO INFUSCALE 7 Instructions for use 10 2 4 Balance Setti
11. in ASCII code For instance 32 represents the Space letter 48 stands for zero Right to it the same data appear in normal readable form In auto mode these two fields allow checking whether correct data are transmit ted from the balance to the PC INFUSCALE 7 Instructions for use 26 5 2 3 Terminal By clicking on the screen of a VT100 compatible terminal appears It allows the observe the incoming balance data and the RS232 control signals In mode abfr also the signals that are transmitted from the PC to the balance are displayed E Picture 15 Terminal display during data acquisition These raw data can be recorded on file extension CAP and played back afterwards On acti vating the capture function with a yellow light appears on the right side Clicking on switches recording on and off The seven green lights on the right side reflect the state of the port lines Red means an active state INFUSCALE 7 Instructions for use 27 5 2 4 Start of measurement When all parameters are entered the measurement can be started by clicking on Start If the Tare option M Tare was been marked the computer sends out a Tare command which sets the balance to zero Clicking on Stop stops the measurement Below the 7 file header lines the created file contains in each line the time and the measured weight see next picture Additionally events that have been marked by pressing t
12. the following pop up menue CopyToJPG CopyT oClipboard Clicking the left mouse key on one of the menue items stores the graphic on data file in either BMP or JPG format or copies it to the clipboard from where it can be easily transferred to other programs e g Microsoft Word Note Auxiliary lines are not stored INFUSCALE 7 Instructions for use 52 7 Measuring Accuracy In this chapter we want to give you an overview about the influence of evaporation and the inter rogation error which results from the communication and data processing between electronic balance and computer Other failures like the cannula effect that is based on the lift of the can nula the influence of temperature and geographically latitude to the exactness of measuring are not as important and will be neglected here 7 1 Evaporation The next two graphics show the effect of the evaporation rs m Weight 5 lt 2 1000 5 eight wio 1 640 X2 70 0 T lenge 0085 ime duration 4035 min Measuring interval 300 sec No of points 807 900 0 Start weight 324 5300 g End weight 801 7800 g min weight 801 7800 max weight 324 5300 g 800 0 Weight increase 122 7500 g Increase of volume 122 9713 Time Weight Rate 700 0 0 1000 2000 3000 4000 Time min Time s c Flow rate Set flow rate 0 0000 mlh in fl 2 2841 I R
13. volume 448382 ml Time Weight Rate 0 50 100 150 Time min Time s c Flow rate Set flow rate 0 0000 ml Rate min flow rate 0 2064 ml max flow rate 103 1785 ml mean flow rate 14 5230 ml mean flow error 1600 no of boli 9 mean bolus volume 4 9820 Relative span 100 0 100 0 0 0 0 alal Bl g Picture 26 Bolus evaluation In the upper part the weight of the delivered liquid is displayed as a function of time with the weight at the beginning of the measurement on the lower left side and in the upper right corner the final value On the right margin of the weight curve the minimum and the maximum values are shown as numbers 0 000 bzw 44 73 The steps which represent the delivery of limited liquid volumes boli with a high flow rate can be clearly identified In this example a total of 9 liquid boli have been delivered The lower part of the screen shows the flow rate curve The steep increase of the flow rate during a weight step and its decrease in the time between two boli can be seen very clearly INFUSCALE 7 Instructions for use 45 On the right margin of the flow rate curve the minimum and the maximum rates are shown as numbers 0 2 resp 109 2 Key 5 on the upper left side of the graphs changes the scaling of the ordinate When this key is not pressed the Y range of the curve is identical to the range of Y values of
14. 0 100 00 00 00 00 Start J Stop 5 Interval 5 0 Set 100 00 5 00 00 00 00 00 00 00 00 00 9 Duration min so Picture 9 Timer calibration window The timer can be adjusted by moving the track bar to the right or to the left side A key click on Set sets the new value Clicking 100 sets the timer to 100 Alternatively an automatical timer calibration can be performed The duration of this process is determined by setting the time in the field next to Duration min The test starts after clicking on Start In the green field the time difference between timer time and internal PC time is con tinuously displayed in seconds The deviation in percents is shown in the field above When the test has ended or been interrupted with Stop the optimal timer value is displayed next to Set Clicking on the Set key sets the new value INFUSCALE 7 3 4 Options Instructions for use 18 In frame Options the following selections can be made Options v O Warning Log Check Par 3 4 2 9 auto Win 98 C Picture 10 Log During data acquisition an additional log file is created This file documents the data acquisition process in detail Its extension is LOG OWarning If this field is marked an overwrite warning is displayed after starting the measuring in DATA ACQUISITION MEASUREMENT if the set filename al ready exists Check If this field is marked a horizontal scroll bar app
15. 0 70 0 75 0 80 0 Time min Time s Ed Flow rate Set flow rate 0 0000 in 0 1343 lh Rate Gi mlA Xi 540 X2 70 0 max flow rate 103 4081 ml mean flow rate 49 4039 mith mean flow error 1600 of boli 1 mean bolus volume 4 9404 Relative span 100 0 100 0 Y 50 0 00 00 Picture 27 Bolus measuring In this example at first an enlarged area of the graph based on file BSP6 PMQ between minute 60 and 80 was drawn after clicking on Time Then a measuring between minute 64 01 and 70 00 has been made The upper list shows that the mean flow rate between the two lines is 49 4039 mL h The bolus between the lines has a volume of 4 9404 mL The maximum flow rate between the vertical lines is 103 4081 mL h and 105 9 mL h in the total displayed area INFUSCALE 7 Instructions for use 48 6 2 3 7 Entering Comment lines After clicking on this key the following window opens It contains 4 lines for entering comments which are printed out in the graphic as well as in the test report printout Clicking on hides all comment lines The OK key below stores all lines into the comment memory 6 2 4 Data Output 6 2 4 1 Printout of the Graphs After clicking on this key a printout of two graphs weight and flow rate is made 6 2 4 2 Screen Printout After clicking this key a screen printout is made INFUSCALE 7 Instructions for use 49 6 2 4 3
16. 00 i oii 600 800 al Picture 31 Evaporation with oil film The volume of the container used for the next picture was about 100 mL with an oil film on the liquid surface Within 870 minutes only 0 02 mL of water evaporated The equivalent mean evaporation rate is 0 0014 mL h The comparison of these pictures demonstrate that evaporation can lead to large measuring er rors Therefore it is recommended to work always with an oil film when the measuring has to be very exact or during the measuring of pumps with low flow rates Before this the evaporation rate has to be measured in a first prospective run This rate has to be entered into the program before starting the measuring see chapter 5 2 1 INFUSCALE 7 Instructions for use 54 7 2 Interrogation Error Provided the operation system has been set as described in section 3 1 the timer error of the computer is one to two orders of magnitude below the interrogation error and can therefore be neglected 7 2 1 Mettler Balance AE100 Continuous Operation During continuous operation a data string is sent periodically to the computer by the Mettler bal ance AE100 The time distance between two data transmissions is maximally 440 ms The inter rogation by the computer is done whenever the set time interval has run out and is not synchro nised so that the moment of interrogation may be delayed for a maximum of 440 ms This means that the computer takes a weig
17. 1 38253 4 6 11 5 5 00 05 30 2 63000 34 98974 16 6 12 6 0 00 06 00 2 84000 25 37050 15 4 13 6 5 00 06 30 3 15000 37 39455 24 6 14 7 0 00 07 00 3 35000 24 16810 19 4 Row 1 Column 1 0 0 Picture 24 Table display Trumpet Curve You can scroll through the table by pressing the left mouse key and move the mouse pointer up and down the scroll bar For printing table 3 please click on screen print can be made by clicking on The table data can be stored in an Excel file by clicking The keys e are used for loading and storing the comment lines INFUSCALE 7 Instructions for use 42 6 1 8 4 Test Report After clicking on this key the INFUSCALE test report is displayed Bae amp mu s amp amp Infuscale test report 1 20 2001 filename Bsp2 pmp Measuring date 9 16 1991 Measuring time 16 12 44 Technician Rollenpumpe Serial no 12678 Disposable Schlauch Meas interval 30 sec Set flow rate 30 0000 ml h Evaporation 0 1200 ml h Density 0 9980 g ml No of points 372 Duration 166 00 min Evaluation from minute 60 0 120 0 delivered volume 29 98 ml mean flow rate 29 98 nl h 5 Flow rate error 0 07 5 Trumpet Curve from minute 60 0 120 0 0 Page 1 of 1 Picture 25 Test report of trumpet curve evaluation Clicking amp prints out the test report After clicking on the test report is stored on file in
18. 4 Zoom al After clicking on this key an enlarged area of the flow rate graph can be displayed To determine its position and size please pull a rectangle with pressed left mouse key from the upper left corner to the lower right corner of the enlarged graphic area you want to display 6 2 3 5 Unzoom After clicking this on key the original graph before zooming is displayed INFUSCALE 7 Instructions for use 47 6 2 3 6 After clicking on this key the graphic curves can be measured Holding the left mouse key pressed at first the left vertical line that indicates the lower measuring limit is drawn to the point of curve where the calculation shall start Then in the same way move the upper measuring limit line Curve Measuring INFUSCALE calculates all relevant values between these two borders and displays it in the two listing areas at the right side of the screen Example Lu ETE evaluation la xi rs m Weight a 30 00 Weight 1 64 0 2 70 0 D DetenINFUSCALIDATEN BSPE 64 01 70 00 min 60 0 65 0 70 0 Time min 75 0 80 0 Time range Time duration Measuring interval 6 0 10 min alale No of points 36 25 00 Start weight 147545 g End weight 13 6850 g 20 00 min weight 14 7541 g max weight 13 6850 g Weight increase 4 3305 g 15 00 Increase of volume 4 9404 ml Time Weight Rate 60 0 65
19. 8 2599 INFUSCALE 7 Instructions for use 39 6 1 7 Other Commands 6 1 7 1 Set Time Range Time This key opens an input area for the readjustment of the time baseline X axis of the graphics 5 to Clicking on the key next to Minute sets the range back to a maximum 6 1 7 2 Set Flow Rate Range Rate This key opens an input area for the readjustment of the range of flow rate Y axis of the graph ics Clicking on the key next to Rate sets the range back to a maximum 6 1 7 3 Zoom a Clicking on this key displays an enlarged area of the flow rate graph To determine its position and size please pull a rectangle with pressed left mouse key from the upper left corner to the lower right corner of the enlarged graphic area you want to display 6 1 7 4 Unzoom After clicking on this key the original graphic before zooming is displayed INFUSCALE 7 Instructions for use 40 6 1 7 5 Entering Comment lines After clicking on this key the following window opens It contains 4 lines for entering comments which are printed out in the graphic as well as in the test report printout Clicking on hides all comment lines The OK key below stores all lines into the comment memory 6 1 8 Data Output 6 1 8 1 Printout of the Trumpet Curve After clicking this key a printout of the flow rate graph and the Trumpet Curve is made 6 1 8 2 Screen Print After cli
20. Data interface option 011 In accordance with the installation instructions for option 011 for the Mettler AE Balance the following settings have to be made Data transmission mode send continuously Baudrate 2400 Baud Data bits 7 Stop bit 1 Parity parity enable even parity No protocol Mark Mettler and auto in the Setup screen and check the correspondence of the fixed pa rameters between computer and balance interface see chapter 3 With the correct setting of the COM parameters the balance is continuously sending data to the PC See next sequence for example weight 0 0 gramms lt 7 2 gramms put on balance result not stable DT AJ lt result stable ga Ca C0 C0 CA 31 31 1 10 0 gt 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 Picture 3 Data from a Mettler AE balance During measuring INFUSCALE only accepts stable results INFUSCALE 7 Instructions for use 12 2 4 2 Mettler Precision Balance PM4000 Please make the following settings in the sector I FACE of the balance configuration register data transmission mode Cont all values are transmitted automatically Baudrate 2400 default Parity even parity default Data bits 7 Stop bits 1 Interval pause 0 sec Calibration mark AU on or off Mark Mettler and
21. INFUSCALE Version 7 Instructions for Use INFUSCALE 7 Instructions for use 2 TABLE OF CONTENTS 1 INTRODUCTION neo or CELER 5 1 1 ENHANCEMENTS TO VERSION 6 5 cc sccessssceceessececssscecsesececsesaececseseecsesseeecsesuececeeaeecsesseeecsesueeesseateeeeseeeesees 5 1 2 GENERAL INFORMATION ON THE INFUSION STANDARD ssssscecessseceseecceceeeececeesaececseaeeceesseeecseaeeeeneeeeeess 6 1 3 THE GRAVIMETRIC MEASUREMENT PROCEDURE csssssceeeesseeecseccececseeeeceesaececseeaeceseueeecsesaeeecseaaeeeeseeeeenes 7 2 INSTALLATION 8 2 1 EQUIPMENT REQUIREMENTS eere tenete o y etre reri tere n eer eo c o ees 8 2 2 SOFLWAREINSTALEATION 8 2 3 CONNECTING THE BALANCE TO THE 9 2 4 BALANGESETLINGS x5 utro eom ee att HER ni ERES 10 24 4 Me ttllerAnalysis Balance 100 iine Re ene eic ere RUE 11 2 4 2 Mettler Precision Balance 4000 esses 12 2 4 85 Mettler Balances with SICS Serial Interface esee eene nennen rene eene 12 2 44 Sartorius Balances ee 14 3 MAIN MENU AND SETUP iis i eaeriseees etes test etes aeos eee oed eth SUn Seo S PER e eR steve ere RUN Repas ple eT era sorosoro eae epo 15 3 1 MN C EPT 16 3 2 PRINTER SETUP cene od BR soc ean chet eos Ba
22. USCALE 7 Instructions for use 33 6 1 The Trumpet Curve 6 1 1 The Meaning of the Trumpet Curve according to EN 60601 2 24 In the trumpet curve the minimum and maximum deviation of the measured flow rate which is averaged in 5 respectively 6 different observation windows is plotted against the set delivery rate of the pump The curve shows the mean flow rate deviation per time interval The trumpet curve is a useful information for the physician who has to decide whether a certain infusion pump can be used together with an intended drug Special drugs with short elimination half life demand high standards concerning delivery conti nuity If a remedy with an elimination half life of e g one minute is used flow variations of 15 minute will cause corresponding changes of the plasma level Thus a predictable constant plasma level and a respective drug efficacy is hard to get Example Intravenous given insulin has an elimination half life of 15 minutes Variations of the delivery rate of 15 in the average during a period of 40 minutes will cause similar deviations in the plasma level and as a result unreliable efficacy 6 1 2 Calculation of the Trumpet Curve according to EN 60601 2 24 50 102 Click on key 102 if it is activated This is the case if volumetric infusion controllers or syringe pumps are to be evaluated see chapter 4 1 The time interval has to be exactly 30 s and the dura tion of the measurement must be mor
23. ate Xi 840 X2 70 0 228 d 1 0000 max flow rate 1 4426 ml mean flow rate 1 8286 mith mean flow error 1 5000 no of boli 0 mean bolus volume 0 Relative span 100 0 2 0000 2 5000 2 a Time fri ji 9 a amp e m K Picture 30 Evaporation without oil film In this picture the evaporation container was a bucket containing 4 litres of water without an oil film Within 67 hours 122 75 mL water evaporated which can be observed in the upper graphic as falling weight curve Respectively the evaporation curve below moves between 2 284 and 1 443 This is equivalent to a mean evaporation rate of 1 83 mL h INFUSCALE 7 Instructions for use 53 Lu ATE evaluation E laj xj m Weight C InfuBSgidataivdunst2 pmp Weight Wig Xi 540 32 700 lime range 0810 min Time duration 870 min 0 0050 Measuring interval 500 sec No of points 87 0 0100 Start weight 0 0001 g End weight 0 0204 g 0 0150 min weight 0 0204 g max weight 0 0001 g 280200 Weight increase 0 0203 0 0250 Increase of volume 0 0203 ml m Time Weight Rate 0 200 400 600 800 Time min Time s c Flow rate Set flow rate 0 0000 mith in 0 l Rate Xi 540 X2 70 0 TADS OWES mae 0 0005 max flow rate 0 0006 ml mean flow rate 0 0014 mlh mean flow error 0 0010 no of boli 0 mean bolus volume 0 ml Relative span 100 0 0 0015 0 0020 0 2
24. cking on this key a screen print is made INFUSCALE 7 Instructions for use 41 6 1 8 3 Table Output After clicking on this key the file header the comment lines the single measured weight values and the calculated flow rate values are displayed in three tables The column Error in table 3 shows the percentage error of flow rate in relation to the set delivery rate for each data point In columns Q1 Q62 the mean flow rates are contained At the end of table 3 the calculations ac cording to the standard are shown Points 372 C nfu701 e data Bsp2 pmp Index String Value Index Comment 1 MESSINTERVALL SEC 30 1 2 FOERDERRATE ML H 30 00 2 3 VERDUNSTUNG ML H 0 120 3 4 DICHTE G ML 0 998 4 7 NAME DER PUMPE Roller 6 SERIENNUMMER 12678 7 EINMALARTIKEL TECHNIKER e Index Time min Time h m s Rate mh Error 96 0 0 00 00 00 0 00000 0 00000 100 0 1 0 5 00 00 30 0 09000 10 94164 63 5 2 1 0 00 01 00 0 37000 33 78733 12 6 3 1 5 00 01 30 0 54000 20 56088 31 5 4 2 0 00 02 00 0 83000 34 98974 16 6 5 2 5 00 02 30 1 02000 22 96569 23 4 6 3 0 00 03 00 1 33000 37 39455 24 6 7 3 5 00 03 30 1 53000 24 16810 19 4 8 4 0 00 04 00 1 83000 36 19214 20 6 8 4 5 00 04 30 2 08000 30 18012 0 6 10 5 0 00 05 00 2 34000 3
25. dware and docu ment accuracy measurements of infusion pumps according to sections 50 102 50 104 50 108 of the standard In addition INFUSCALE is useful during the development and the periodic safety checks of infusion pumps INFUSCALE 7 Instructions for use 7 1 3 The Gravimetric Measurement Procedure The gravimetric method is used in determining the accuracy of delivery of infusion pumps Dur ing the measuring procedure the quantity of liquid delivered by the pump under test is weighed in equal time intervals and transmitted to a computer that stores it together with a timestring on a data file In a second process the accuracy data are calculated and documented computer Picture 1 Measuring setup The measuring setup picture 1 is made according to IEC standard requirements see pictures 104a and 104b of the standard It consists of the pump with disposable accessories an electronic balance and the connected digital computer The measuring is controlled and documented by INFUSCALE Depending on the type of pump See chapter 50 102 50 108 of the standard the pump and the measuring devices are set and started The pump delivers liquid water for medical use according to ISO class III into the container located on the balance plate The weight of the container increases in proportion to the delivered volume and is in regular intervals transmitted to the computer and stored on file The menu option for performing this procedur
26. e is started by clicking on Data Acquisition Measurement Note Nutrition pumps must be tested with the specified nutrition solution instead of water Be fore starting measuring the density of the nutrition solution must be determined and entered into the respective field After the measuring is finished the data can be analysed by calling up the menu item Evalua tion With pumps of group 50 102 the evaluation according to EN 60601 2 24 is very easy You just have to load the data file and click on key 102 Prerequisite is a time interval of 30 seconds between two data points and a duration of measurement of 2 hours which is equivalent to at least 241 measuring points With other pumps i e pumps with bolus delivery or pumps with non continuous delivery char acteristics an automatic analysis is not recommended In those cases the user s analysis is sup ported by different options in the menu Evaluation INFUSCALE 7 Instructions for use 8 2 Installation 2 1 Equipment Requirements Electronic balance with RS232 interface uni or bidirectional Picture 2 shows a list of balances supported by INFUSCALE PC with Windows 95 98 NT 2000 XP or 7 operating system Colour Graphic Display of at least 800 600 pixel resolution RS232 computer interface installed as COMI COMA Printer installed on LPT1 or LPT2 All printers which are accepted by Windows can be used Connection line between
27. e refer to the standard or to picture 11 The evaluation with INFUSCALE is described in chapter 6 1 2 4 2 Drip Rate Infusion Controllers and Drip Rate Infusion Pumps 50 103 The standard does not recommend the gravimetric method but a drip counting method INFUSCALE 7 Instructions for use 20 4 3 Infusion Pumps for Ambulatory Use Type 1 50 104 Ambulatory pumps with continuous delivery characteristics are concerned Measuring inter 900 s 2 15 min val Set delivery rate the measuring must be made at the following set rates minimum adjustable rate intermediate rate specified as typical by the manufacturer For further details please refer to the standard or to picture 11 The evaluation with INFUSCALE is described in chapter 6 1 3 4 4 Infusion Pumps for Ambulatory Use Type 2 50 105 Ambulatory pumps with non continuous delivery are concerned i e repetitive delivery of equal boli during the whole delivery period The measuring must be made with 20 and subsequent 100 shot cycles at intermediate rate as specified by the manufacturer Further details are described in the standard and in picture 11 The evaluation with INFUSCALE is described in chapter 6 1 4 4 5 Infusion Pumps for Ambulatory Use Type 3 50 106 Ambulatory Infusion and Syringe Pumps with Bolus Equipment are concerned pumps that are able to deliver single discrete boli The measuring must be made with 25 consecutive boli at the mi
28. e than 2 hours After clicking INFUSCALE evaluates the data according to section 50 102 of the IEC standard For each observation period of 2 5 11 19 and 31 minutes the program calculates the minimum flow rate maximum flow rate Qpmax maximum negative deviation of mean flow rate maximum positive deviation of mean flow rate percentage error A resp B related to the set delivery rate These values are plotted as Trumpet Curve INFUSCALE 7 Instructions for use 34 The next picture shows the Trumpet Curve of the second hour of example file BSP2 PMP Lu Trumpet Curve second hour s xj rs rm Flow rate C nfu amp Sgdata Bsp2 Rate Time 0 120 60 00 Duration 120 min Weight 0 00 60 09 Volume 60 4504 40 00 Rate 10 94 3850 Set rate 30 0000 minh mean rate 30 2252 m 20 00 20 00 Error 0 75 Time Rate 0 00 0 20 40 60 80 100 120 Time min Time Trumpet Curve from minute 60 0 120 0 Evaluation from Min 60 0 to 120 0 Window Epmin Epmax 2 min 28 9777 31 9837 3 4076 6 6124 5 min 29 3384 30 9016 2 2052 3 0052 11 min 29 7975 30 0708 0 6749 0 2360 19 min 29 7371 30 1801 0 8762 0 6004 31 min 29 8310 30 1025 0 5632 0 3418 Q 29 9797 AS 0 07 Deviation ad s au 2 9 amp e e sx i Picture 20 Trumpet Curve of the second hour In the windo
29. ears in table Balances By moving to the right all other fields of this table can be viewed They contain the setting parameters of each balance Par The 4 fields are related to the data format of the set balance Field 1 Number of balance type Field 2 balance index Field 3 First read digit of a received data string starting from left Field 4 Number of read digits If balance custom auto is marked the user can enter values into field 3 and 4 see above This allows the adaptation of already not supported balances to INFUSCALE Win98 If INFUSCALE has been installed on Windows 98 this checkbox must be marked In case of Windows NT 2000 XP or 7 this field remains empty Key 44 leads back to the main menu INFUSCALE 7 Instructions for use 19 4 Infusion Pumps according to EN 60601 2 24 The following chapters refer to the respective chapters of the standard EN 60601 2 24 4 1 Volumetric Infusion Controllers Volumetric Pumps and Syringe Pumps 50 102 The following measuring conditions are defined in the standard Measuring inter 30 sec val Set delivery rate The measuring must be made at the following set rates a Volumetric pumps and controllers minimum adjustable rate but at least 1 mL h intermediate rate 25 mL h b Syringe Pumps minimum adjustable rate but at least 1 mL h intermediate rate 5 mL h Measuring time More than 2 hours For further details pleas
30. erval S Clicking on El terminates the input INFUSCALE evaluates the file data now calculates n n 30 minutes di vided by S and draws the respective graphs Each point of the flow rate curve over T1 repre sents the average of n data points as required in the IEC standard The observation periods of the trumpet curve calculated over T2 are 1S 2S 5S 11S 19S and 31S depending on the time inter val S L Trumpet Curve la rs fc Flowrate 8510 3 600 2 Rate Qi mlAh Time 0 200 min Duration 200 min 3 000 Weight 0 000 4 920 9 Volume 4 9622 Rate 0 551 1 933 mlh 2 000 Set rate 1 5000 mih mean rate 1 4987 1 000 Eror 0 76 Time Rate 0 000 50 100 150 200 Time min Time Trumpet Curve from minute 200 1250 Evaluation from Min 200 to 1250 Window Epmax 10 min 1 0919 1 8734 27 2035 24 8903 20 min 1 4526 1 6630 3 1602 10 8650 50 min 1 4165 1 6209 5 5645 80600 110 min 1 4963 157893 0 2459 5 2185 190 min 1 4969 1 5918 0 2075 6 1196 310 min 1 4972 1 5689 0 1871 4 5957 0 1 5299 1 99 5 Deviation aus sj 49 m Picture 22 Trumpet curve according to section 105 INFUSCALE 7 Instructions for use 37 6 1 5 Calculation of an optional Trumpet Curve By clicking on gt INFUSCALE can calculate and draw a Trumpet Curve for any time range
31. ge of two data points as required in the IEC standard The observation periods of the trumpet curve calculated over T2 are 15 60 150 330 570 and 930 minutes Mi Trumpet Curve B 8 xi s c Flow rate TODD 01 PMG Rate Di ml h Time 0 500 Duration 500 Weight 0 0000 0 8227 g 0 2000 volume 0 8242 ml Rate 0 03001 0 1691 Set rate 0 1000 mean rate 0 0999 0 1000 Error 0 10 Rate 0 0000 0 100 200 300 400 500 Time min Time Trumpet Curve from minute 500 1560 Evaluation from Min 500 to 1560 Deviation Window Qpmin Qpmax Epmin Epmax 15 min 0 0305 0 1703 69 5452 70 3066 50 min 0 0978 0 1026 2 2240 2 5847 150 min 0 0978 0 1017 2 2240 1 7431 330 min 0 0978 0 1016 2 1694 1 6193 570 0 0985 0 1013 1 5280 1 3403 930 min 0 0995 0 1001 0 4531 0 0704 0 0 0993 AS 0 72 sol ss Picture 21 Trumpet curve according to section 104 INFUSCALE 7 Instructions for use 36 6 1 4 Calculation of the Trumpet Curve according to EN 60601 2 24 50 105 Key 165 is activated when infusion pumps for ambulant use of type 2 to be evaluated see chapter 4 4 The specifications of section 50 105 of the IEC standard apply Clicking on this key opens the input area 1 from minute o to S M0 The startup period T1 can be entered here as well as the measuring int
32. h ing of a special purpose of use Liability for any damage during use of this program is excluded as far as lawful Contact Dr Gerd Juhl Kreckestr 10 80997 Munich Germany Email gjuhl infuscale com INFUSCALE 7 Instructions for use 5 1 Introduction The Infuscale program serves for the exact evaluation of the delivery accuracy of infusion pumps and controllers by the gravimetric method according to the international standard IEC601 2 24 EN60601 2 24 It operates with electronic balances and runs on IBM compatible computers on Windows 95 98 ME NT 2000 XP and 7 operating systems INFUSCALE provides powerful features including Acquisition of balance data and storage on file Storage of event markers Operation with Mettler Sartorius Ohaus Chyo Precisa and Kern balances Graphical and numerical display of data and event marks Evaluation of data according to the specifications of the harmonized standard EN60601 2 24 IEC601 2 24 or to the user s own requirements Evaluation according to MDA Device Bulletin DB2003 02 Calculation of Trumpet Curves Calculation of the Constancy Index Graphical display of weight and flow curves Storage of graphics as BMP or JPG files and to the Clipboard Display of values as tables and test reports Screen printout table printout printout of test report Storage of test report as Microsoft Word and Excel file and in the data file formats TXT WMF
33. he blank key on the PC keyboard are stored in a separate line The name of the technician is automatically stored in the last line Example INTERVAL E 2 30 FLOW RATE 20 0000 1 PORATION 0 0000 ENSITY 0 9982 AME OF PUME Example 5 ERIAL NUMBE POSABLE 226 733 25 22703 30 2 33 29 28 03 28 28 33 21 29 03 26 129233 25 30 03 29 30 33 28 23120327 31 33 26 23250325 132 33 29 33 03 28 33 33 21 2945 03 20 usw ER S 00000 02041 12840 28762 45998 64032 80385 96463 12811 29109 44685 59950 74942 90455 06292 23061 I 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 MNL F p T Picture 16 Infuscale data file INFUSCALE 7 Instructions for use 28 During the program run the following values are shown on the screen Upper line 1 Starting time Actual PC time Measuring time Time difference between measuring time and starting time Event number Event time Ov UN d Middle line Index Stored time string Stored weight Calculated mean flow rate since start of measurement mean rate Percentage deviation of the mean flow rate in relation to the set delivery rate Actual delivered volume in mL Ne px p In the middle windows weight and flow rate are plotted in two graphs against time By clicking on the keys below the number of data points s
34. hown can be set E g if key 100 is pressed 100 measuring points are displayed When exceeding this number the curve is scrolling to the left By clicking on all the maximum number of 10000 points can be seen When the key Time is pressed down the time format of the x axis changes from minutes to hh mm ss 1 minute is displayed as 00 01 00 INFUSCALE 7 Instructions for use 29 Rate Qifmi h MN 0 458 Picture 17 Data acquisition INFUSCALE 7 Instructions for use 30 5 2 5 Event marker During measurement an event can be marked by pressing the blank key of the PC keyboard Such an event is displayed in the control area see 5 2 2 and is stored in the INFUSCALE file Events are displayed on evaluation screens and tables 5 2 6 Storage of Graphics on File and to Clipboard When the cursors is pointing on a graphic a click on the right mouse key shows the following pop up menue CopyT oBMP CopyToJPG CopyT oClipboard Clicking the left mouse key on one of the menue items stores the graphic on data file in either BMP or JPG format or copies it to the clipboard from where it can be easily transferred to other programs e g Microsoft Word
35. ht value that was applied maximally 440ms before the correct moment of interrogation With an average measuring interval of 30 sec the error is maximal 1 596 During the determination of the trumpet curve 4 to 62 measuring values are averaged So the error will be reduced to about 0 38 The next table picture 23 shows the max interrogation error and the average errors for the smallest observation window p 4 of the trumpet curve dependent from the time interval The shown maximum errors are extreme values Picture 32 Maximum error dependent of the time interval Mettler auto INFUSCALE 7 Instructions for use 55 7 2 2 Sartorius Balance MCI automatic data transmission The Sartorius balance MCI transmits periodically a data string to the computer Sartorius auto The time interval between two consecutive data transmissions is max 220 ms The interrogation by the computer is done whenever the set time interval has run out and is not synchronised so that the moment of interrogation may be delayed by maximally 220 ms This means that the computer takes a weight value that was applied maximally 220 ms before the correct moment of interrogation The next table picture 24 shows the maximum interrogation error and the average errors for the smallest observation window p 4 of the trumpet curve dependent from the time interval Picture 33 Maximum error dependent of the time interval Sartorius auto INFUSCALE 7 Instructions f
36. lt Parity E even parity default Data bits 7 Stop bits 1 Handshake OFF End of line mode CRLF b data transmission on request by the computer Data output condition ALL Baudrate 2400 default Data bits 7 Stop bits 1 Parity even parity default Handshake OFF End of line mode CRLF The selection in the SETUP screen must be either Mettler S auto or Mettler S abfr INFUSCALE 7 Instructions for use 14 2 4 4 Sartorius Balances All Sartorius balances of types AC BA BL BP LA LC LP MC RC SC CP have a RS 232C port They can be operated in two different modes a continuous data transmission to the computer data output condition auto without standstill Baudrate 9600 default Data bits T Stop bits 1 Parity E even parity default stopbits 1 handshake hardware handshake with 2 figures after CTS b data transmission on request by the computer data output condition without standstill Baudrate 9600 default Data bits 7 Stop bits 1 Parity E even parity default stop bits 1 handshake hardware handshake with 2 figures after CTS In accordance with the balance configuration the setup of INFUSCALE must be either Sarto om rius auto or Sartorius abfr INFUSCALE 7 Instructions for use 15 3 Main Menu and Setup After starting INFUSCALE the main menu appears on the screen The options Data Acquisi tion Evaluation
37. mouse pointer up and down the scroll bar For printing out table 2 please click A screen print can be made by clicking on a The table data can be stored on an Excel file by clicking on The keys e are used for loading and storing the comment lines INFUSCALE 7 Instructions for use 50 6 2 4 4 Test Report After clicking on this key the INFUSCALE test report is displayed F4 Test report 8 x OSB urn SS e Infuscale test report 1 20 2001 filename Bsp2 pmp Measuring date 9 16 1991 Measuring time 16 12 44 Technician Pump Rollenpumpe Serial no 12678 Disposable Schlauch Meas interval H 30 sec Set flow rate 30 0000 ml h Evaporation 0 1200 nl h Density 0 9980 g ml No of points 372 Duration 166 00 min Evaluation from minute 0 186 Time interval 186 00 min No of points 372 Weight range 0 00000 92 79000 g Weight increase 92 79000 g delivered volume 93 35 al Range of flow rate 10 94164 38 59695 ml h 0 Page 1 of 1 Picture 29 Test report of bolus evaluation Clicking on amp prints out the test report After clicking on the test report is stored on file in TXT WMF HTML CSV RTF or XLS format A data transfer to Microsoft Word and Excel is easily possible INFUSCALE 7 Instructions for use 51 6 2 4 5 Storage of Graphics on File and to Clipboard When the cursors is pointing on a graphic a click on the right mouse key shows
38. ngs The next table gives an overview of balances supported by INFUSCALE Mettler SICS AB S AG AT AX MT X X 2400 Bd 7 1 MX PB S PG S PR SB SG SR UMT UMX Sartorius AC BA BL BP LA LC 9600 Bd 7E1 EXT RC SC CP GA 110 160 160 4800 Bd 7 1 Picture 2 Balances and setting parameters In column 3 and 4 the operation modes of the balances are marked auto stands for continuous data transmission from the electronic balance to the computer abfr stands for data transmission on request by the computer On some balances both transmission modes can be selected INFUSCALE must be configured according to the mode selected at the balance see chapter 3 Column 5 of picture 2 contains the default parameters preselected by the balance manufacturer e g baudrate 9600 bd word length 7 bit 1 stop bit and even parity for Sartorius balances In the Setup screen these default parameters can be automatically taken over from an internal table by pressing Preset values However any other value can be selected if necessary for proper communication It is important that the settings of computer and balance correspond The next chapters give additional information for specific balance setups INFUSCALE 7 Instructions for use 11 2 4 1 Mettler Analysis Balance AE 100 integration time step 2 3 sec normal setting stability detector step 2 normal setting
39. nimum setting either demanded manually or by program Further details are described in the standard and in picture 11 The evaluation with INFUSCALE is described in chapter 6 2 4 6 Infusion Pumps for Ambulatory Use Type 4 50 107 Combination of non continuous delivery and bolus delivery Testing shall be done according to subclauses 50 104 50 105 and 50 106 of the standard as appropriate Please refer to the standard or to picture 11 The evaluation with INFUSCALE is described in chapters 6 1 3 6 1 4 and 6 2 INFUSCALE 7 Instructions for use 21 4 7 Infusion Pumps for Ambulatory Use Type 5 50 108 Only for parenteral nutrition or patient controlled infusion Use subclause 50 102 to 50 106 of the standard as appropriate For further details please refer to the standard or to picture 11 The evaluation with INFUSCALE is described in chapters 6 1 2 6 1 3 6 1 4 and 6 2 Note Nutrition pumps must be tested with the specified nutrition solution instead of water Be fore starting measuring the density of the nutrition solution must be determined and entered into the respective field 4 8 Other medical pumps EN 60601 2 24 does not refer to implanted pumps or other pump systems in medical use How ever INFUSCALE can be used for these pumps as well 4 9 Overview of Infusion Pumps according to EN 60601 2 24 Sect Type in Intemed Intermed Intermed Intermed Bolus Bolus Measur rate rate Rate Rate min max Inte
40. o detect very small air embolus Small flow rate increments Good bolus accuracy Rapid start up time TPN Volume sensitive except Small occlusion bolus Fluid maintenance neonates Able to detect small air em Transfusions bolus ZW Small flow rate increments Application of Diamorphin long half Any except neonates life of metabolite Bolus accuracy TPN Any except volume sensi Long term accuracy Fluid maintenance tive or neonates Alarm after occlusion Transfusions Small occlusion bolus Able to detect air embolus Incremental flow rates Drugs other than those with a short Any except neonates Good long term accuracy half life gt 5 min Alarm after occlusion Therapy categories and performance parameters Minute to minute variability of flow becomes very important where drugs with short half lives are being administered The importance derives from the need to prevent undesirable fluctuation of effect site concentration of the drug There is documented evidence that minute to minute variability of flow can cause variation of physiological parameters and consequent difficulties in management in both adults and neonates where the half life of the drug is short Short term accuracy is expressed by the concept of constancy index This is the shortest period during the pump s steady state operation over which measurement of output consistently falls within 10 of the mean rate The data are derived from the flow test
41. on 31 observation intervals instead of 5 or 6 L Trumpet Curve m 218 8 s Flow rate Bsp2 Rate 60 00 Volume 933480 ml Rate 1094 3880 338 Setrate 30 0000 Ut BeRRAI 4 4 RM 4lII iI RI Mean rate 30 1122 mih Eror 0 37 AKWA LCMS LAETI ALIM MIASA MILAI ulli TAEDA TM L UA CEN palco 20 00 i MONTE Time Rate 20 00 ic santo mi a a m Sm i 1034 0 00 T 0 50 10 150 Time min Time Modified Trumpet Curve from minute 0 186 Evaluation from Min 0 to Deviation 5 C Index 4 min Noe Doer ppm T min 223645 33 1861 25 7296 10 20 Fern 2min 25 0699 33 1861 16 7452 10 20 3min 26 7733 32 9857 11 0883 0 54 4min 27 6250 32 5840 8 2599 8211 5 Akas Lett Smin 28 2563 322242 6 1635 70127 a gt 0 Lat T 03T 5 124 L D i 14 15 16 17 18 10 2D 21 22 23 24 25 26 27 28 20 3D 31 PORK ISGcER SNL ppa pap aa EL p M aul 4 Picture 23 Modified trumpet curve and constancy index In this example the constancy index is 4 as shown in the upper edge of the trumpet curve Graphically the index is represented by a vertical broken line In this example Epmax is 48 211646 Epmin is
42. or use 56 7 2 3 Sartorius Balance MC1 request mode In the request mode Sartorius abfr the Sartorius balance is requested by the computer pe riodically after the time interval has run out As response a data string is sent back to the com puter The maximum measured error is 60 ms in a test situation In normal operation a maximal error of 30 ms can be expected The next table picture 25 shows that this mode is more accurate than the automatic data trans mission mode at least for measurements with short time intervals Picture 34 Maximum error dependent of the time interval Sartorius abfr INFUSCALE 7 Instructions for use 57 8 Symbols and Formula T Total measuring time in minutes k Number of measuring points r Set delivery rate mL h i Measuring index 1 1 tok At Time interval min between two consecutive measuring points t Measuring time min at point i p Observation window index with p 4 10 22 38 62 tpi Observation window with tpi tup i2 p At Wi Weight g at the measuring point i corrected by the evaporation loss d Density of water 0 998 g mL at 20 C Flowrate mL h between two consecutive measuring points 60 W Wi Qi d At Wb Weight g delivered during the observation window MN si Wig Wi Total weight g delivered during the total time T corrected by the evaporation loss W Wi Wo Q Average flowrate mL h during the to
43. rval 100mmHg 100mmHg container 0 5 m below D 50 105 Amb Type2 Tes Picture 11 Set delivery rates according to IEC601 2 24 sections 50 102 50 108 4 10 Classification of Pumps The British Health Ministery has published recommendations for users of medical infusion pumps These publications are based on technical evaluations user assessments incident report ing and on own evaluations Device bulletin 2003 02 addresses problems in the use and selec tion of infusion systems and the training of users It raises awareness of the nature of infusion systems their advantages and risks INFUSCALE 7 Instructions for use 22 Regarding clinical application pumps have been divided into three major categories according to the potential infusion risks These categories A B and C are shown in the next table with a list of the performance parameters critical to each The categories have been selected on the principle that in general the greater the potential risks associated with therapies the higher the perform ance needed and the more important are the safety features Therapy Therapy description Patient group Performance data Category Drugs with narrow therapeutic margin Good long term accuracy Drugs with short half life 5 min Good short term accuracy Any infusion given to neonates Neonates Rapid alarm after occlusion Small occlusion bolus Able t
44. s performed over 24 hours at Iml h Flow is recorded at 30 second intervals over the final 18 hour period And the average rate compared with flow over each short period The constancy index of the pump should be less than or equal to the half life of the drug used Syringe pumps have a shorter constancy index than volumetric pumps i e a low constancy index indicates good short term flow rate accuracy INFUSCALE 7 Instructions for use 23 5 Performing the Measuring computer Picture 12 Measuring setup 5 1 The Measuring Setup The measuring setup consists of the following components Balance with RS232 interface Windows computer with RS232 interface COMI COMA connection line between computer and electronic balance liquid container silicon oil for the oil film cannula G18 or G21 The balance must be installed perfectly plain in a vibration free environment and must be cali brated The container of the infusion pump that is to be tested must be filled with water corre sponding to ISO class III The connected infusion line with a long cannula must be primed In the liquid container placed on the measuring plate a little amount of water is filled in with an oil film on the top about 0 5 cm This film reduces the evaporation of the water during the long measuring period The tip of the cannula is placed directly under the oil film so that a continuous water pillar be tween the infusion container the inf
45. ses PR esa ees bietet ERIS 17 3 3 TIMER CALIBRATION iiio ee ee iet ies epee iet ere vem Dites ec pee 17 3 4 OPTIONS ec ARTA E e si ei eee 18 4 INFUSION PUMPS ACCORDING TO EN 60601 2 24 19 4 1 VOLUMETRIC INFUSION CONTROLLERS VOLUMETRIC PUMPS AND SYRINGE PUMPS 50 102 19 4 2 DRIP RATE INFUSION CONTROLLERS AND DRIP RATE INFUSION PUMPS 50 103 19 4 3 INFUSION PUMPS FOR AMBULATORY USE TYPE 1 50 104 20 4 4 INFUSION PUMPS FOR AMBULATORY USE TYPE 2 50 105 20 4 5 INFUSION PUMPS FOR AMBULATORY USE TYPE 3 50 106 20 4 6 INFUSION PUMPS FOR AMBULATORY USE TYPE 4 50 107 20 4 7 INFUSION PUMPS FOR AMBULATORY USE TYPE 5 50 108 21 4 8 OTHER MEDICAL PUMPS 5 tee ide tee ree c dp epe pep ee e bee ee ei 21 4 9 OVERVIEW OF INFUSION PUMPS ACCORDING TO EN 60601 2 24 sess enne 21 4 10 CLASSIFICATION OF PUMPS IR PIRE ERI ee EE e ee 21 5 PERFORMING THE MEASURING eee seen eene eene ense tn setas ta stesse s toss ease toss 23 5 1 MEASURING SETUP
46. t flow rate of the tested pump Time interval between two measuring points in seconds INFUSCALE 7 Instructions for use 25 Evaporation Evaporation rate in mL h Density Density of the test fluid in g mL Total time Measuring time in minutes 0 or no time limitation When entering the parameters please regard the conditions described in the IEC601 1 24 stan dard and referenced in chapter 4 of this manual By pressing TAB or ENTER the next field is highlighted for input The shortest time interval is 1 second Please note that such a short time period will increase the measuring error see chapter 7 Right to the Pump field the set balance is displayed Next to it is a green light that changes to red if a new data line is transmitted to the PC The Target field shows name and path of the INFUSCALE file to be stored By clicking on this field a new file name can be entered 5 22 Control of Data Transfer The area displayed on the lower left part of the screen serves for measuring control Im Start time act time Meas time Time diff Event no Event time 15 01 51 16 01 55 16 01 55 00 00 04 1 00 00 02 Index Time string Wei ght mean rate mean error Volume 4 00 00 04 00 0 00000 0 0000 0 0000 32 82 22 22 22 22 22 49 46 42 22 22 32 32 0 0 COM1 3600 7E1 Picture 14 Displayed values during data acquisition On the bottom line the data received from the balance are shown
47. tal time T 60 W Q d T Qi Average flowrate mL h during the observation window t 60 Wai Qp d tpi Oni Maximum mL h for each observation window t and each value of p Qpmin Minimum Q mL h for each observation window t each value of p INFUSCALE 7 pmax 7 Instructions for use 58 Highest positive deviation of max for each p expressed as percentage devia tion from the set rate r T 100 r Highest negative deviation of Q max for each p expressed as percentage devia tion from the set rate r Qpmin E 100 r Percentage total error of the average flow rate Q related to the set rate r during the total time T Q r A 100 96
48. the data file When this key is pressed the maximum Y of the curve is rounded to the next even value above the maximum Y value of the data file If key 1 is pressed two dotted lines are drawn in the flow rate curve marking the minimum and maximum flow rates The lists on the right side of the screen display the calculated values as numbers 6 2 2 Bolus Evaluation with adjustable Time Range By clicking on key in screen Evaluation an INFUSCALE file with adjustable time range can be calculated and displayed The following input area opens immediately after clicking in which the user can enter the desired time range for calculation T1 from Minute to 186 Clicking El terminates the input and start the evaluation INFUSCALE 7 Instructions for use 46 6 2 3 Other Commands 6 2 3 1 Set Time Range Time This key opens an input area for the readjustment of the time baseline X axis of the graphics to fimo Clicking on the key next to Minute sets the range back to maximum 6 2 3 2 Set Weight Range Weight This key opens an input area for the readjustment of the weight range Y axis of the graphics Clicking on the key next to Weight sets the range back to maximum 6 2 3 3 Set Flow Rate Rate This key opens an input area for the readjustment of the range of flow rate Y axis of the graph ics Clicking on the key next to Rate sets the range back to a maximum 6 2 3
49. ture 2 In the frame COM Port the computer port to which the electronic balance is connected can be selected 3 1 Terminal After clicking on a VT100 compatible terminal screen opens This terminal observes the data coming in from the balance to the PC in auto mode These raw data can be recorded on file extension CAP and played back afterwards The following functions are implemented Start Start of data display Stop Stop of display Capture Entering the name of the capture file and start recording Play Open and play a capture file Exit Terminal switch off On activating the capture function a yellow light appears on the right side Clicking on switches recording on and off The seven green lights on the right side reflect the state of the port lines Red means an active state INFUSCALE 7 Instructions for use 17 3 2 Printer Setup The printer setup can be made in frame Print Print HP DeskJet 970C Series an LPT1 e 300 dpi 5l Picture 8 Printer setup window by clicking on al The field next to it shows the set printer resolution which is in this exam ple 300 dpi 3 3 Timer Calibration The internal timer controls data acquisition very accurately Its setting normally does not need to be changed However for calibration purposes there is the possibility to accelerate or delay this timer by 5 compared to the internal PC Clock r Timer calibration 10
50. usion line and the liquid container on the balance is main tained Thus an influence of the measuring accuracy by the drop formation on the end of the can nula is prevented INFUSCALE 7 Instructions for use 24 5 2 Data Acquisition Data acquisition is started by clicking on Data Acquisition Eve Simulation 1 Exit The following screen appears 1 Sartorius m Target czinfuzote data Test pmq Technician Meas interv f s Serial no Evaporation 0 0000 mih Disposable Density 0 9982 g ml Set flow rate 0 0000 mih Total time min Weight Flow rate 0 5 Weight 0 10000 Rate 0 00000 0 4 04 03 03 0 2 0 2 0 1 0 1 0 0 0 0 0 0 0 5 10 15 0 0 05 10 15 Time min Time min 30 100 300 1000 12000 Time Start time act time Meas time Time diff Event no Event time Index Time string Weight mean rate mean error Volume Start 0 00 00 00 00 0 00000 0 0000 0 0000 Tare Stop Timer Intervall 82 82 32 32 32 32 32 48 45 48 82 0 0 COM1 3600 7E1 100 00 g Picture 13 Measurement screen 5 2 1 Entering data In the upper part of the screen the following parameters can be entered Pump Technician Serial no Disposable Set flow rate Meas Interval Name of the pump under test Name of the technician performing the measuring Serial number of the pump under test Used disposable Se
51. w right to the flow rate graph the calculated values are displayed as numbers e g the maximum and minimum flow rates 38 60 resp 10 94 The total error A resp B is shown in the window right to the Trumpet Curve A 0 07 Note the row of keys on the bottom left 101 15 30 These keys allow the setting of the deviation range of the Trumpet Curve The standard setting is t 15 deviation Key 5 on the upper left side of the flow rate graph changes the scaling of the ordinate When this key is not pressed the Y range of the curve is identical to the range of Y values of the data file When this key is pressed the maximum Y of the curve is rounded to the next even value above the maximum Y value of the data file Clicking on calculates and displays the Trumpet Curve for the last hour INFUSCALE 7 Instructions for use 35 6 1 3 Calculation of the Trumpet Curve according to EN 60601 2 24 50 104 Key 404 is activated when infusion pumps for ambulant use of type 1 are to be evaluated see chapter 4 3 The measuring interval in this case is 15 minutes The specifications of section 50 104 of the IEC standard apply Clicking on this key opens the input area 1 from minute o to 200 The startup period T1 can be entered here Clicking on El terminates the time input INFUSCALE evaluates the file data now and draws the respective graphs Each point of the flow rate curve over T1 represents the avera
52. ys are activated which lead to a reasonable evaluation according to the IEC standard This will be explained later in this chapter INFUSCALE 7 Instructions for use 32 For opening another file please click on the field right to filename A selection window ap pears immediately in which the file can be marked and opened evaluation filename c Infuz te data Bsp2 pmp e J EH 60601 2 24 50 Technician Stat pumps 102 Amb pumps 1 104 Pump Rollenpumpe Serial no 12678 Amb pumps 2 105 Disposable Schlauch Amb pumps 3 106 Setflowrate 30 0000 mih Meas interv 30 s Evaporation 0 1200 mih Density 0 9980 gimi Trumpet Curve iz x of points 372 Total time 186 00 min Bolus evaluation g aal Picture 19 File has been loaded The list on the left side contains the raw file data and the line index In the center part of the screen the file parameters which have been entered before starting the measurement are dis played The name of the technician can be entered if necessary The keys gt e and RB can be used anyway Clicking on these keys lead the user directly into the program modules Trumpet Curve Modified Trumpet Curve and Constancy Index or Bolus Evaluation The calculations are made without restrictions regarding the minimum dura tion of measurement gt 2 hours 44 leads back to the main menu INF
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