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SIBELMED W20s

1. 101 2 18 UPDATE OF THE DEVICE S 101 2 19 DOWNLOAD DATA FROM THE 103 3 105 3 1 SOFTWARE 65 106 3 1 1 COMPUTER INSTALLATION AND REQUIREMENTS 106 3 1 22 OPERATING SYSTEM 106 3 1 3 SPIROMETER COMPATIBILITY 107 3 1 4 PC SPIROMETER CONNECTIVITY 585555999494 7 107 3 1 5 PROGRAM CONFIGURATION iri 107 3 1 6 DATA BASES EY c Ebook 108 3 2 TESTS FUNCTIONS AND 85 108 9 2 1 FORCED VITAE CAPAGCLTY 108 3 2 2 QUALITY OF FVC TEST tte teh 110 3 2 3 INTERPRETATION ALGORITHMS DIAGNOSIS 113 3 2 4 PREDICTED SETS ENAS 115 3 2 5 SLOW VITAL CAPACITY i tnter enki 116 3 2 6 MAXIMUM VOLUNTARY 116 2 POSTBRONCHODILATION TEST 117 511 BLO MU2 REV 1 06 ETE KEEN E3727 7 22722228 SIBELMED W20s User s Manual 5 3 2 8 BRONCHOCONSTRICTION 117 3 2 9 MAXIMAL PRESSURES OPTION 118 3 2 10 PULSE OXIMETRY OPTION eere nen 120 3 3 GENERAL DATA
2. SIBELMED W20s Users Manual 165 Bronchodilator substance administration BE Partial Dose mg ml feo BD Substance Salbutamol c fg 3rd Step CONSTRIC BC1 Modify the data if necessary Apply the first dose of bronchoconstrictor medicine and press OK Start a series of maneuvers again TESPIROMETRY SOFTWARE SIBELMED W20s Data Base sibel x Dose mg ml 18 2 4 6 8 1012141618202224 DIS 0 04 0 4 4 0 40 0 BDI Reduces the graphic curves e The chronometer is activated at the top left of the dose response window after application of the medicine When the count down has finished an alarm rings indicating that the programmed time has finished e The chronometer resets and goes off when the next maneuver begins 511 BLO MU2 REV 1 06 i aN Ey 2727 22 279 SIBELMED 205 Users Manual 166 e At any time when the chronometer is on you can click on it to stop the count down reset it or stop the alarm The action taken over the chronometer depends on its state Store the best maneuver in a similar way to the previous steps once the maneuvers of the constrictor step have been performed 4th Step CONSTRIC BC2 BC3 BC10 The same procedure as in the previous step but for the second third tenth dose as they are necessary When the FEV1 value drops under 20 with regard to the diluent or the basal if the d
3. 54 2 9 FORCED VITAL CAPACITY TEST PROCEDURE 56 511 BLO MU2 REV 1 06 D EE E3727 7 22722228 SIBELMED W20s User s Manual 4 2 9 1 ENTERING PATIENT AND ENVIRONMENTAL PARAMETERS ates Ib 56 2 9 1 1 ENTERING PATIENT AND ENVIRONMENTAL PARAMETERS THROUGH WORK LIST 54 2 9 2 ENTERING FORCED VITAL CAPACITY 5 5 62 2 939 MANEUVER DATA Ru a 67 2 9 4 PRINTING THE 71 2 10 SLOW VITAL CAPACITY TEST PROCEDURE 74 2 11 MAXIMUM VOLUNTARY VENTILATION MVV TEST 76 2 12 RONCHODILATION TESTS 78 2 13 IMPORTING TESTS FROM THE 83 2 14 EXPORT OF TESTS TO OTHER 5 6 5 84 2 14 1 ORGANIZATION OF THE WINDOWS 85 2 14 2 EXPORT DESTINATION etn runter 86 2 14 3 EXPORT TESTS TO e MAIL nnn mmn 89 2 14 4 IMPORT OF TESTS FROM A REMOTE CONSULT 89 2 14 5 DISPLAY OF RESULTS THROUGH OTHER SYSTEMS 91 2 14 6 EXPORT FROM THE DATA 92 2 15 CALIBRATION PROCEDURE 94 2 16 ACTIVATION 100 2 17 SOFTWARE
4. input for the smoker index the weather data and the ethnic factor will be deactivated if they are not used in the Maximal Pressure Test 511 BLO MU2 REV 1 06 S be 1N7eC SIBELMED W20s User s Manual 145 2 4 1 1 PERFORMANCE OF MAXIMAL PRESSSURE TESTS After the test data have been validated with the OK key the screen of tests performance is accessible SPIROMETRY SOFTWARE SIBELMED W205 Data Base sibel x Selup Options Manmouvres tetmancewvres Ets menu It is recommendable for the technician who is performing the maximal pressure tests to know the usual procedure required so that the patient performs the test correctly Otherwise it is advisable to check some bibliography on this subject In the test performance follow these steps 1 Connect the module to the connector no 9 The device automatically detects that the module is connected The device will indicate if the module is not connected and it will not allow starting the maneuver Ensure also that the Shutter Probe is connected to the module 511 BLO MU2 REV 1 06 Wi S be iNeCC SIBELMED W20s User s Manual 146 2 Train the patient on the test performance as his her collaboration is essential for the correct execution Put him her the nose clip 3 Press the START key and wait until the key icon changes into green color The shutter probe m
5. 122 9 921 MEASUREMENT SYSTEM 122 3 3 2 ANALYSIS CRITERIA 2259 thus 123 3 3 3 USEFUL MIRE 123 3 9 4 STORAGE orren Ir E Rule 123 3 3 5 STANDARDS aia 124 3 4 SYMBOLS 125 4 MAINTENANCE 126 ANNEX 1 2 3 5 n rra eerie rreerer 128 PULSE TEST 128 A1 1 INTRODUCTION 129 A1 2 PULSE OXIMETRY 129 A1 3 PULSE OXIMETRY CONFIGURATION 130 A1 4 PULSE OXIMETRY TEST PROCEDURE 132 A1 5 PERFORMANCE OF PULSE OXIMETRY TESTS 133 A1 5 1 INPUT OF PATIENT AND TEST 133 A1 5 2 PERFORMANCE OF PULSE OXIMETRY TESTS 134 A1 5 3 PRINTING AND OR SAVING IN THE DATABASE 137 ANNEX 2 eee 140 MAXIMAL PRESSURES TEST 140 A2 1 INTRODUCTION 141 A2 2 MAXIMAL PRESSURES PROGRAM 141 A2 3 MAXIMAL
6. SIBELMED 205 Users Manual 158 A3 1 BRONCHOCONSTRICTION TEST PROCEDURE A3 1 1 TEST DESCRIPTION For the performance of the bronchoconstriction test is recommended to those people who are not familiarized with this type of test to check some bibliography about it See The European Respiratory Journal Volume 6 Supplement 16 March 1993 or Normativa para los Tests de Provocaci n Bronquial Inespec fica by the Sociedad Espa ola de Neumolog a y Cirug a Tor cica among others The bronchoconstriction tests consist of performing a forced spirometric test before and after the application of different pharmacological or physical stimulus to the patient and then evaluate the changes produced in the spirometric parameters specially the drop of FEV1 Notice the test has several forced spirometric maneuvers and the best maneuver is selected to include it in the summary report according to the criteria in the different standards Next there is a short description of the different steps taking part in the configuration process The steps described are not the only possible although the most accepted ones The spirometer can to perform the test according to two different methods e Normal or continuous method It consists of applying to the patient a certain concentration for a specified time e Abbreviated method It consists of applying to the patient a certain number of inhalations of a certain conce
7. SIBELMED 205 User s Manual 114 1 lt 80 Light 1 lt 65 Moderate FEV1 lt 50 Strong 1 lt 35 Very Strong e If FEV1 FVC gt FEV1 FVC Reference and FVC lt 80 of FVC Reference gt Ventilatory alteration of non Obstructive type FVC lt 80 Light FVC lt 65 Moderate FVC lt 50 Strong FVC lt 35 Very Strong e If FEV1 FVC gt FEV1 FVC Reference and FVC gt 80 of FVC Reference gt Ventilatory alteration of Mixed type suspected e If FEV1 FVC lt FEV1 FVC Reference FEV1 gt 80 of FEV1 Reference gt Ventilatory alteration of Mixed type suspected e If a bronchodilation test is made and the FEV1 POST surpasses in 15 to the FEV1 basal or PRE gt There is positive reaction to the bronchodilater substance Interpretation ATS ERS According to Pellegrino et al Task force Standardisation of Lung Function Testing Eur Respir J 2005 26 948 968 Interpretation NLHEP Only valid for references that calculates the LLN For example Hankinson According to Ferguson et al Office Spirometry for Lung Health Assessment in Adults Chest 2000 117 1146 1161 511 BLO MU2 REV 1 06 SIBELMED 205 Users Manual 115 3 2 4 PREDICTED SETS Predicted set Country Region Age range years SEPAR SPAIN 6 to 70 ERS EUROPE 18 to 70 1 KNUDSON EEUU 6 to 84
8. C FET 2 TE H The maneuvers are compared to the values of the patient reference e The Report key brings out the test report up to the performed step e The Delete key deletes the selected maneuver e The Summary key show the data of the performed steps e The Dose key saves the best maneuver and goes on to the next step This key is actually deactivated when entering the bronchodilation step e The Dilat key saves the best maneuver and goes to the bronchodilation step This key is activated if at least the diluent step has been performed Press Dose to store the maneuver and go to the next one 511 BLO MU2 REV 1 06 Wi eT S be 77CC SIBELMED W20s User s Manual 164 2nd Step DILUENT DIL Apply the diluent with neutral PH to the patient if you have selected this option Start a new selection of forced maneuvers once the normalized time has elapsed TESPIROMETRY SOFTWARE SIBELMED W20s Data Base m 59 rers 38e Qe 1 161 1 2 ts 60 2 4 6 8 1012141618202224 Reduces the graphic curves e The maneuvers are compared to the stored basal e The DATA icon gives you access to the display of the data After the adequate maneuvers have been performed press the DATA icon to display the data and again Dose to store the best maneuver and go to the next step 511 BLO MU2 REV 1 06 5
9. 16 2 4 1 SPIROMETRY SOFTWARE INSTALLATION 16 2 4 2 OPTIONAL MODULES 21 2 4 3 BLUETOOTH MODULE 21 2 4 4 USB DRIVER INSTALLATION 22 2 4 5 SETUP i o npa tup Ca at 24 2 4 6 SPIROMETRY SOFTWARE UNINSTALLATION 24 2 5 ABOUT ON SCREEN HELP enean nnns 25 2 6 MAIN 26 2 7 SOFTWARE 27 2 7 1 PRINTER SELECTION enn nnnm nen 28 2 7 2 PARAMETERS INTERPRETATION PREDICTED SETS 28 2 7 3 GRAPHICS PEDIATRIC INCENTIVES AND LANGUAGE SELECTION 32 2 7 4 SOFTWARE LINKS 36 2 7 8 DEVICE CHECK ono reni sia 37 2 7 6 UTILITIES ker ua Ia er ke edax ae ead 39 2 77 ABOUT 39 2 8 DATA E EN UAE 40 2 8 1 PATIENT CARD 40 2 8 2 EXPLORE DATA 46 2 8 3 DATA BASE MAINTENANCE 52 2 8 4 EXPORT TESTS IN CSV FORMAT 53 2 8 5 IMPORT TESTS IN CSV FORMAT
10. i Ate Motive Procedence LY The input of smoker index weather data ethnic factor and references are deactivated when they are not used in the pulse oximetry test 511 BLO MU2 REV 1 06 SIBELMED W20s User s Manual 134 1 5 2 PERFORMANCE OF PULSE TESTS After having validated the test data with the key OK the performance tests screen will be shown The screen shows the message green READY Press the key START to begin the study The pulse oximeter will start to take samples The Oxygen Saturation SpO and the Pulse Rate PR values and the corresponding peripheral pulse waveform are represented The duration of the wave record on screen is 5 seconds srimore rav sorrware w2os Data nase E va 2815 Setup Options ep egg aso s 5 2 LPR J 00 000 READY 00 00 00 If the Acoustic Warning is activated a sound warning will also be heard The message in yellow APPLY THIMBLE PROBE can also appear when no peripheral pulse wave is detected In this case the values SpO and PR will remain zero as well as the perfusion waveform If the finger probe is disconnected from the device a message in red will appear TRANSDUCER DISCONNECTED 511 BLO MU2 REV 1 06 SIBELMED W20s Users Manual 135 The following screen shows an example of di
11. Cough PETUS AEE Wheezing 9 FEVL FVC 91 11 79 11 30 10 FEV3 FVC 4 97 67 ll 8 12 1 5 6 60 10 06 66 Sputum P l3 FEF75 1 5 1 85 Hs 94 14 FEFSO l s 3 77 5 30 71 Status 000349 000352 4404 1099 511 BLO MU2 REV 1 06 5 SIBELMED W20s Users Manual 94 2 15 CALIBRATION PROCEDURE The Spirometry Software SIBELMED W20s requires another product to be able to fulfill its functions As a consequence it does not include any calibration system as this is performed from the linked spirometer except while connecting with the DATOSPIR 600 as this device doesn t have auser interface and the calibration is done through this software CALIBRATION PROCEDURE FOR DATOSPIR 600 GENERAL OBSERVATIONS As previously mentioned the current standards for the spirometry recommend that all the spirometers must be calibrated periodically This is due to the alterations which can modify the characteristics of the electronic circuits and mechanical elements and produce a change the spirometer calibration factors For this reason a calibration system has been integrated using a signal of reference volume for example a syringe Besides this calibration factor the changes in volume associated to weather conditions temperature relative humidity and pressure must be taken into accoun
12. CRAPO EEUU 4 to 91 1 ZAPLETAL EUROPE 4 to 17 MORRIS EEUU 24 to 100 AUSTRIA AUSTRIA 6 to 90 1 GUTIERREZ CHILE 5 to 100 1 CASTRO PEREIRA BRAZIL 6 to 76 1 POLGAR WENG 4 to 100 HANKINSON EEUU 4 to 100 NHANES IIT PEREZ PADILLA MEXICO 7 to 100 A J CRUZ MEXICO 17 to 64 1 GOLSHAN IRAN 6 to 81 1 GARCIA RIO EUROPE 65 to 85 CANDELA SPAIN 2 to 7 PLATINO LATIN AMERICA 40 to 90 Mexic Chile Venezuela Brazil Uruguay THAI 2000 THAILAND 10 to 100 1 If other ages are used the predicted values are extrapolated Itis possible to include other references For this purpose contact SIBEL S A Technical staff Ethnic Factor for Predicted values Patient Identification Data Environmental Data temperature pressure and relative humidity Graphics in FLOW VOLUME and VOLUME TIME mode 511 BLO MU2 REV 1 06 a ea SIBELMED 205 Users Manual 116 Graphics for motivation in pediatric tests Concordance Maneuver Warnings with the ATS ERS criteria 3 2 5 SLOW VITAL CAPACITY Parameters e VC I Slow Vital Capacity e TV Tidal Volume e ERV I _ Expiratory Reserve Volume IRV Inspiratory Reserve Volume e IC I Inspiratory Capacity e Ti 5 Inspiratory Time e Te s Expiratory Time e Tt s Total Time e Ti Tt Relation Normalized Predicted Sets to be selected among different standards Ethnic Factor for Predicted values Patient Identification Data Environm
13. SIBELMED W20s User s Manual 60 PT rav sor TWARE saman wa m mE AHE sl Esteri petet When pressing FVC the type of test FVC is selected 2 9 1 1 ENTERING PATIENT AND ENVIRONMENTAL PARAMETERS THROUGH WORK LIST If the W20sLink option has been purchased and SibelHL7link or External Bridge Application is selected in the Interoperability menu it is not necessary to enter patient data to initiate spirometry tests since they are included in the work list that is imported from the external Information System HIS Select OPTIONS Spirometry in the Main Menu or press the icon corresponding to a patient making a maneuver of spirometry and the work list screen is displayed 511 BLO MU2 REV 1 06 DUE Ey 2727 22 279 4208 SIBELMED 205 Users Manual 61 S elsi CEE x Code Mime Procedence 38063607N Gallardo Lopez Isabel Maria SANT PAU 00 00 00 Ramos P rez Carlos SANT PAU FYCMB 00 00 00 Enters in Spirometry Manu options This list shows the data of scheduled patients to perform spirometry tests ID Code Name Procedence Type of Test and Hour of Realization To select a patient you must simply place above it and double click Then the test data tab is displayed if you want to modify some parameter After clicking the Accept button takes you to the test required in the work list for the selected patient Each one of the demands that compose the
14. or keys of fast advance each 10 records until the needed card is found 511 BLO MU2 REV 1 06 ey ear a SIBELMED W20s User s Manual 50 TRENDS Check DATA BASES PATIENT CARD PATIENT DATA Check DATA BASES PATIENT CARD EXPORT TO DISK Check DATA BASES EXPORT CSV FORMAT TESTS EXPORT TO MAIL Check EXPORT OF TESTS TO OTHER SYSTEMS IMPORT Check DATA BASES IMPORT CSV FORMAT TESTS WINDOW MARK It allows selecting a patient or a test If the Patient window is active when selecting a patient all the patient s tests will be also selected UNMARK It allows unmarking the selected patient or test If the Patient window is active when unmarking a patient all the patient s tests will be also unmarked MARK ALL If the Patient window is active all the patients and their tests get selected If the Tests window is active all the tests of the selected patient get selected UNMARK ALL If the patient window is active all patients and tests get unmarked If the Tests window is active all the tests of the selected patient get unmarked 511 BLO MU2 REV 1 06 ear A SIBELMED W20s User s Manual 51 TILED All the patients and tests subwindows get positioned in a tiled way HORIZONTAL MOSAIC It moves all the patients and tests subwindows one under each other VERTICAL MOSAIC It moves all the patients and tests subwindows side by side UPDATE It updates th
15. 3 1 4 PROGRAM CONFIGURATION Software setup by the user in the following aspects Type of printer 511 BLO MU2 REV 1 06 S e N7C7 SIBELMED W20s Users Manual 108 e Parameters diagnosis references and others e Graphics pediatric motivation and language e Data Bases Communication Links with the software 3 1 5 DATA BASES e Possibility to work with different Data Bases e Storing of spirometric tests in FVC VC Postbronchodilation or MVV e Storing of tests and graphics Creation deletion modification in the patient cards e Fast consulting in the data base by Record Reference Surname e Printing Reports from the data base 3 2 TESTS FUNCTIONS AND PARAMETERS 3 2 1 FORCED VITAL CAPACITY Parameters e FVC 1 Forced Vital Capacity e FEV 5 Il Forced Expiratory Volume in 0 5 seconds 511 BLO MU2 REV 1 06 ee 5 SIBELMED W20s User s Manual FEV1 FEV3 FEV 5 FVC FEV1 FVC FEV3 FVC FEV1 VC PEF FEF25 FEF50 FEF75 FEF25 75 FEF75 85 FET25 75 FET100 FEV1 FEV 5 FEV1 PEF e FIF50 e FIVC e FIV1 e FIV1 FIVC e FEV1 FIV1 e PIF e MTT e PEF PIF e Vext e MVVInd e FEV6 e 6 COPD rate 511 BLO MU2 REV 1 06 FEF50 FIF50 Il Idem in 1 second I Idem in seconds 9o Relation 9o Relation 9o Relation 9o Relation 1 5 Peak Expiratory Flow 1 6 Instantaneous forced expirato
16. 5 45 96 70 51 FEV1 FVC 71 11 90 79 11 91 54 FEV3 FVC 97 67 99 92 FEV1 VC 1 8 6 60 66 10 06 10 10 75 1 8 1 85 94 1 97 3 16 FEF50 1 5 3 77 71 5 30 6 17 FEF253 1 5 5 61 9 32 FEF25 75 1 s 3 41 80 4 24 5 68 FEF75 85 1 s 1 47 2 44 FET25 75 s 0 88 0 44 FET100 s 6 33 4 16 FEF50 FIF50 1 00 152 0 66 1 00 MTT s 0 82 0 42 FEV1 FEV0 5 1 55 107 1 45 1 30 FEV1 PEF 10 77 162 6 64 7 55 50 1 8 3 76 6 17 FIVC 1 6 00 5 00 FIV1 1 4 26 4 58 FIVl FIVC 71 09 91 65 FEV1 FIV1 1 00 125 0 80 1 00 PIF 1 s 6 50 9 87 PEF PIF 1 02 73 1 39 1 02 Vext 1 0 06 0 08 MVV Ind 1 127 92 137 28 FEV6 1 6 00 5 00 FEVl FEV6 8 71 11 91 54 COPD index Lung Age 25 11 15 36 Repeatability ATS ERS FVC No FEV1 No Alerts ATS ERS PRE POST ET DU ERU 5 SIBELMED 205 User s Manual Interpretation Miller s Interpretation Values in the range of predicted Normal Interpretation REV 1 06 Time 09 05 2014 Height cm 175 Wgt Kg Humidity 65 Transducer Disk Ethnic F 3M PRED 17 94 7 106 25 116 17 94 24 7 106 15 42 25 116 2 42 100 52 160 48 116 50 50 134 50 66 40 0 152 63 17 90 34 114 49 17 7 25 0 125 41 0 74 24 7 17 25 47 100 Smok I BMI 11 28 76 24 8 sibel sibel sibel ID Code Name Sex Temp 9C Reason Procedence Technician Predicted F BTP
17. 205 Users Manual 173 always have read and write access for their subdirectory and the files that make up the subdirectory The rest of the users may have access to said database totally denied for example It must be taken into account that in this situation the users may only access their database from the application On the log file ESPWIN log level it would be advisable for the users to only have read access so that the application could register the accesses to the different databases Permissions can be applied from Windows Explorer itself Simply access the Properties of the directory of file to which you wish to establish permissions and select the Security tab From this tab you can select both the users who may access and the permissions total control read modification write etc of each user File audit We recommend the activation of the log file audit in order to register on the security event viewer the actionsperformed upon it To activate this option you must first enable the audit of said file At this level you must specify the users according to the users which access the lt W20s_HOME gt Bdsibel directory and types of access to be audited The log file audit can be activated from the Security tab of the file Properties Using the Advanced button you can access the Audit tab From here simply add the users and the type of access to be audited It must be taken into account that if all actions upon the l
18. Hardware Test TEST cPu CPU Checks the control code from the BIOS Flash RAM and UART A D Obtains the voltage values of the equipment and the connected transducers and atmospheric values of the weather station SpO Shows the pulse and blood oxygen saturation values Communications Tests Sends and receives testing commands to check the connection between the equipment and the computer Reset Factor Resets the pulses counter when a turbine transducer is linked to the equipment 511 BLO MU2 REV 1 06 Wi SIBELMED W20s User s Manual 39 2 7 7 UTILITIES Depending on the selected device the Utilities menu will appear in the Links menu with the next options D120 D110 Micro and TOUCH Spirometers Activation Code e Software purchase Update Flash Download data of the device D600 Activation Code e Software purchase Update Flash This options are explained in detail in sections ACTIVATION CODE SOFTWARE PURCHASE UPDATE OF THE DEVICE S SOFTWARE and DOWNLOAD DATA OF THE DEVICE respectively at the end of this chapter 2 7 8 ABOUT This option shows an information window with the program s data e Version e Date Manufacturer s Data 511 BLO MU2 REV 1 06 5 SIBELMED 205 Users Manual 40 SS Version 511 BLA 1 00 Date 30 03 2011 SIBEL S A C Ros
19. In the case of storage for paper prints containing patient details it is required that said documents remain duly safeguarded in such a way that only duly authorized personnel have access to them Likewise in the case of a user deciding to dispose of the printed documents it will be necessary to ensure their effective physical destruction in order to avoid unauthorized access to data Exporting tests The software allows for tests to be exported only if the user is identified and authorized to read the database Once the test has been exported to a file the software user is responsible for the security of said file and its later deletion Data transmission The software permits the transmission of files with patient data via the internet If this functionality is used the user must configure their e mail server so that the data is encrypted before transmission and is therefore converted into unintelligible data for any unauthorized access 511 BLO MU2 REV 1 06
20. REINDEX It allows reordering the data base when some error in its operation is detected This option can be made at any time is needed but it can take some time depending on the amount of stored information PRESENT DELETED RECORDS When a record is deleted in the Data Base this remains hidden but it is not deleted definitely except when the option pack records is used If you want to display them at any moment this option is activated PACK RECORDS This option is used to delete definitely the deleted records and to reorganize the data base records This option can be used at any time but it can take some time depending on the amount of stored information 511 BLO MU2 REV 1 06 DU NEUE Ey 2727 2272294208 SIBELMED W20s User s Manual 53 2 8 4 EXPORT TESTS IN CSV FORMAT This program module allows the export of tests to format marked by inverted comas files with extension CSV so that they can be read by other systems You can enter this module from the main menu option Data Base Export Tests CSV Format By entering this option the program opens the exploring window To perform the export the next steps must be followed TI SPIROMETRY SOFTWARE SIBELMED W205 Data Base sibel 5 x Setup Data Bases Options Window Help Li Reference Name Date Time Type Value r 001 1111111111 Lopez Garcia Francisco 002 2222222222 Sanchez Grau Maria 002 20 09 2010 10 25 5 4
21. SIBELMED 205 User s Manual 49 Preliminary View shows a preliminary view of the test s report The screen also present the following information It presents the Observed and Predicted values of the different parameters as well as the If the option Save 3 best maneuvers is selected in the Setup Graphics and Others menu you will be able to select which maneuver is displayed among the 3 best stored maneuvers It shows the Quality Control alerts according to ATS ERS or NLHEP criteria regarding the following ET End of Test ATS ERS and NLHEP EX Start of test ATS ERS and NLHEP PEFT Time to reach PEF only NLHEP If the test was performed with the NLHEP quality control criteria the QC Grades will be displayed when 2 or more maneuvers were performed during the test sesi n In case of a Bronchodilation test The PRE and POST QC Grades will be displayed the QC Grades are not shown when using the ATS ERS criteria It shows whether the patient had cough weezing dyspnea or sputum during the test Each of these symptoms can have the following values White No symptom Green Mild symptom Yellow Moderate symptom Red Severe symptom When the status box is activated it indicates that the record has been deleted It displays the selected record and the total number of records n the Data Base It is possible to explore the different tests of the same patient through the keys slow advance record by record
22. e Surname e Nr of Record Next press CONSULT enter the information corresponding to the patient searched It is also possible to navigate through the data base with the keys slow advance record by record or keys of fast advance each 10 records until the needed card is found The card shows the number of records of the base and the number of selected record 511 BLO MU2 REV 1 06 5 SIBELMED 205 User s Manual When pressing TRENDS the next screen appears TESPIROMETRY SOFTWARE SIBELMED W20s Data Base 5 x Setup Pink Window Reference rn Best VC a 5 99 o Hour po 23 03 2005 002 23 03 2005 902 23 03 2005 147 Symptoms Maximum value D Ws Bv _ vaba 1 iy FIC In this window all the patient tests FVC are displayed in order to make a report of the trend for parameters FVC FEV1 PEF and its Variability The following options are presented Setup This option allows to Setup the printer type and the Display Parameters Selection It allows selecting a test to include it in the trends report It is possible to mark all the tests or one by one In order to select a group in a quick way follow these steps Mark the first test of the group and then with the Capitals key pressed choose the last test of the group with the mouse by doing this th
23. 100 2 3 the largest with clip sensor 511 BLO MU2 REV 1 06 a ea SIBELMED 205 Users Manual 122 DATOSPIR TOUCH Measurement Range SpO2 Pulso BPM 0 100 30 235 mem 3 Resolution 80 a 100 2 2 70 a 80 the largest of both CONTROL Start and ending of the maneuver suitable to the user One only valid study until the change of patient When initializing the data the program allows starting a new study for the same patient 3 3 GENERAL DATA 3 3 1 MEASUREMENT SYSTEM Transducer Turbine type Fleisch type or Disposable type depending on the spirometer Measurement Scale Flow from 16 1 5 to 16 1 5 Volume from to 101 e Accumulative Volume Time Three curves FVC of maximum 60 seconds each Three curves VC of maximum 60 seconds each Three curves MVV of maximum 60 seconds each 511 BLO MU2 REV 1 06 UNES Ey 2727 22 2794208 SIBELMED W20s Users Manual 123 3 3 2 ANALYSIS CRITERIA e Start expiration FVC Calculated by the retrograde extrapolation method e Final expiration FVC Calculated when the accumulated volume in the last second is lower than 0 025 liters e Selection of tests FVC Performed according to the criteria of maximum addition of FVC FEV1 or at the operator convenience e Selection of parameters The displayed parameters are the corresponding to the selected maneuver selected by the op
24. 5 SIBELMED 205 User s Manual 113 A B and C grades indicate a reliable result but a grade D or F indicates a poor quality test in this case the results should be interpreted with caution GRADE TEST CRITERIA At least 2 acceptable maneuvers with the A VERY GOOD largest 2 FEV values matching within 100mL and the largest 2 FEV values matching better than 100mL B GOOD At least 2 acceptable maneuvers with FEV values matching between 101 and 150mL C ACCEPTABLE At least 2 acceptable maneuvers with FEV values matching between 151 and 200 mL Only one acceptable maneuver or more than D POOR one but the FEV values match gt 200 ml with no interpretation F NOT No acceptable maneuvers with no ACCEPTABLE interpretation 3 2 3 INTERPRETATION ALGORITHMS DIAGNOSIS The Spirometry Software SIBELMED W20s includes two types of diagnosis available through SETUP PARAMETERS AND OTHERS SELECTION Miller Diagnosis It presents the following information NORMAL RESTRICTIVE OBSTRUCTIVE or COMBINED Snider Kory amp Lyons Diagnosis It is based on the following criteria e If FVC gt 80 of FVC Reference and FEV1 gt 80 of FEV1 Reference gt Values in reference range Normal Diagnosis e If FEVi1 FVC lt FEV1 FVC9o Reference and FEV1 lt 80 of FEV1 Reference gt Ventilatory alteration of Obstructive type 511 BLO MU2 REV 1 06 Tit 5
25. CSV and GRAFxxx CSV Usually 001 5 B TRANSPORT These files will be sent by e mail or transferred through an interchangeable disk or floppy disk to the local consult C IMPORT Execute the CSV import process as indicated below Enter the option lt lt Database Import test CSV format gt gt in the main menu The following window appears Choose the directory and the csv file you want to import fisPiROMETRY SOFTWARE SIBELMED W20s Data Base sibel Setup DataBases Options Patient Explore Data Base Maintenance Export tests CSV Format Import tests CSV Format The following window appears 511 BLO MU2 REV 1 06 7 aay SIBELMED 205 User s Manual 91 Data Import Data Base D SIBEL W20s Bdsibel sibel E xj NO REFERENCES No Reference Typo Pl Date Time 1111111111 FVC 0002 1111111111 FVC 5 46 3 89 20 09 2010 10 25 00 0003 1111111111 FVC 1 24 0 92 20 09 2010 10 30 00 0004 1111111111 VC 3 72 0 77 20 09 2010 10 37 00 0005 1111111111 VC 3 35 1 11 20 09 2010 10 42 00 es a OR 4 26 20 09 2010 10 20 00 lala Click with the mouse over the tests to be imported to the data base of the spirometry software SIBELMED W20s click over the key S All in order to select all the tests Click over the key The program will show the percentage of the import Data Imp
26. Nevertheless accidents may happen in the transport or 511 BLO MU2 REV 1 06 S be 1N7ed SIBELMED W20s User s Manual 14 storage so it is convenient to make a status check before installing it as well as of its accessories The Spirometry Software SIBELMED W20s consists of REF 0 Description 07828 1 Spirometry Software W20s CD media 511 BLA MU2 1 Spirometry Software W20s User Manual English Language paper media The software has the possibility to enable the next software options REF 07969 Bronchoconstriction Software option for W20s 07070 MIP MEP Sniff Software option for W20s 07071 Pulse oximetry Software option for W20s 08181 HIS connectivity module compatible ECAP ICS for W20s Spirometry software 08182 Standard HIS connectivity module for W20s Spirometry software 108279 W20s link Module HL7 CDA XML Spare Parts and components REF 03658 05 CableType 2 0 01811 Serial connection RS 232 Cable for 01145 Bluetooth USB PC adapter 08165 Galvanic isolator for USB 06611 Ethernet Cable 511 BLO MU2 REV 1 06 Ty SST S be 17eC SIBELMED W20s User s Manual 15 2 3 MANUFACTURER S LIABILITY SIBEL S A is only liable for the safety reliability and working order ofthis product if e The computer monitor and accessories where the software is used meet the low voltage Directive particularly EN60950 standard and EMC Di
27. PIF 0 Grade 75 85 1 s v FIFSO 1 5 Vext 1 VC and MVV Parameters v vc dv Te v mv L min 1 dv ic s Br fin v v Ti Te 8 Interpretation pr Predicted Dilation G Disabled Adults Children 4M PRE POST X C Miller Diag SEPAR SPAIN SEPAR SPAIN X C Snider Kory Lions Diag NLHEP M Alerts C ATS ERS Ethnic Factor 100 Calibration F Quality Control Q Q This option allows the user to setup or select the following e FVC Tests Parameters e VC and MVV Parameters Interpretation algorithms Diagnosis e Disabled e Miller chart e Snider Kory amp Lyons Interpretation ATS ERS Interpretation NLHEP See section INTERPRETATION ALGORITHMS DIAGNOSIS in the TECHNICAL SPECIFICATIONS chapter for a detailed description e Predicted sets available for Adults and Children 511 BLO MU2 REV 1 06 5 SIBELMED W20s Users Manual SEPAR e ERS e KNUDSON e CRAPO e ZAPLETAL e MORRIS e AUSTRIA GUTIERREZ e CASTRO PEREIRA e POLGAR WENG e HANKINSON NHANES III e PEREZ PADILLA e A J CRUZ e GOLSHAN GARCIA RIO e CANDELA e PLATINO e TAHI 2000 See the section PREDICTED SETS in the TECHNICAL SPECIFICATIONS chapter for a detailed description e Ethnic Factor The ethni
28. Passwords icon on the Control Panel Using the Advanced Administration button on the Advanced Options tab you can access the Local and Group Users setup gt From the Users branch new users can be created or existing properties modified The access level of users can be set up in user properties on the Users tab of the Users and Passwords icon We recommend that users are not given Administrator access level In event the Administrator is the person responsible for ensuring that users use their identification in the ways determined both technically and by documentation as well as making them aware of their obligations in relation to the treatment of personal data It is also advisable to activate the security audit in order to register valid and erroneous accesses to the system Access setup and control File access grants The following step is to set up the access levels to the files which form the databases in relation to the previous users The database root can be found the lt W20s_HOME gt Bdsibel directory Inside there is a subdirectory per database as well as the register file log ESPWIN log One possible setup is to provide full access to the lt W20s_ HOME gt Bdsibel directory to all users or al least to the application users and to restrict access to each of the subdirectories according to the user that they belong to In any event the owner must 511 BLO MU2 REV 1 06 n A S be 11eCC SIBELMED
29. So the new program runs smoothly you MUST leave the loading screen turn off the device and turn it on again From now on the device will work perfectly with the new version of the software 511 BLO MU2 REV 1 06 a 5 SIBELMED W20s Users Manual 2 19 DOWNLOAD DATA FROM THE DEVICE The spirometers DATOSPIR 110 120 DATOSPIR MICRO and DATOSPIR TOUCH have the option of transferring information to the computer This information is saved in internal files and contains data about Hardware Checking e Software Checking Personalization of the device e Calibrations register e FVC Tests If you detect any problem with the device that you cannot solve send this information to SIBEL S A After Sales Department or to your local Dealer who will analyze and evaluate the origin of the problem and will try to give the adequate solution To transfer this information follows the next steps 1 Turn on the device and select the option Auto checking Execute all the sub options following the screen instructions 2 Connect the device to the computer and select the link parameters Setup Links Select the option Setup Utilities Download data of the device 4 Click on DATA to transfer the information The data gets stored inside the application directory in the files STATUS CSV It contains the detected errors CALIBRA CSV It contains the calibration data CONFIG CSV It contains t
30. be in the second place and M1 in the third place See the corresponding data window Summary or data window the next page If the three maneuvers differ in more than 5 this will be indicated through an intermittent red message gt 5 The horizontal line of dots indicates the reference value The vertical line of dots indicates the position of maximal pressure for each maneuver 511 BLO MU2 REV 1 06 a A S e N7C7 SIBELMED 205 Users Manual 150 C Test Summary window or data window This window displays the test data as the maneuvers are being performed The data are updated after each maneuver and when the references are changed in the setup option The average values and the standard deviation are calculated from the best three maneuvers In a rectangle with white background there is information about the reference and patient name Unlike in the spirometry in the maximal pressure test the maneuvers are ordered as they are being performed This is made because it is important to follow the patient evolution Although the maneuvers are stored in the memories in temporal order the best three maneuvers in the window Best Maneuvers are ordered from worst to best one the best maneuver is the one with a higher pressure value It is important to point out that although the program has space for 5 maneuvers more maneuvers can be performed After performing the sixth maneuver the first performe
31. can create Adobe Acrobat files also known as Portable Dacument Format PDF files on Windows zl NNO in a miter deine 3 teamafaemna tha aanavia nestas Taccept the agreement I do not accept the agreement 19 Setup PDFCreator iol xi Select Components Which components should be installed Select the components you want to install clear the components you do not want to install Click Next when you are ready to continue custom installation Programfiles GPL Ghostscript 9 05 14 9 MB Images2PDF 1 0 MB 3 COM samples 0 3 MB Help files 0 2 MB English help File 0 2 MB French help File 0 2 MB German helo file 0 2 Current selection requires at least 34 9 MB of disk space lt Back Cancel 511 BLO MU2 REV 1 06 SESE S be inNed SIBELMED W20s User s Manual Setup PDFCreator 1 x Ready to Install Setup is now ready to begin installing PDFCreator on your computer POF FORGE Click Install to continue with the installation or click Back iF you want to review or change any settings Destination location C 4rchivos de programalPDFCreator Setup type Custom installation Selected components Programfiles GPL Ghostscript 9 05 Images2PDF COM samples Help files English help file gt gt i Completing the PDFCreator Setup Wizard Setup
32. check the computer s Operating System User Manual Printer compatible with the operating system used 2 OPERATING SYSTEM COMPATIBILITY Windows 98 SE e Windows 2000 SP 4 e Windows XP SP1 SP2 or SP3 e Windows Vista 32 or 64 bits SP1 or SP2 e Windows 7 32 or 64 bits SP1 e Windows 8 32 or 64 bits 511 BLO MU2 REV 1 06 Tit ey SIBELMED 205 Users Manual 107 SPIROMETER COMPATIBILITY The software can be connected to the following DATOSPIR spirometers and its accessories 3 1 3 DATOSPIR Touch models Easy T Easy D Diagnostic T Diagnostic F amp Diagnostic D with or without DATOSPIR Touch amp Sniff modules DATOSPIR Touch SpO2 module DATOSPIR Micro models A B amp C with or without DATOSPIR Micro SpO2 module DATOSPIR 120 models A B C and D with or without o DATOSPIR 120 110 600 MEP MIP amp Sniff modules DATOSPIR 120 110 600 SpO2 module DATOSPIR 110 models A and C with or without o DATOSPIR 120 110 600MEP MIP amp Sniff modules DATOSPIR 120 110 600 SpO2 module DATOSPIR 600 models D F and T with or without o DATOSPIR 120 110 600 MEP MIP amp Sniff modules o DATOSPIR 120 110 600 SpO2 module PC SPIROMETER CONNECTIVITY The software installed on a PC can be connected to spirometer RS 232 port USB port Bluetooth wireless port Note Not all the spirometers support all the connectivity
33. connected to the computer e The Channel for the communication between the spirometer and the computer It can be a serial or a Bluetooth channel For USB connection this is not used because its plug amp play feature e The Serial Port which will be used if this channel has been selected Firstly verify how many serial ports the computer has and which ones of them are free For Bluetooth connection you have to select the serial port assigned by the Bluetooth software check the Bluetooth Adapter installation fist For USB connection this is not used e The Transmission Speed of the signal which must be the same that is selected in the spirometer and the highest one is suggested unless some error is detected For USB connection this is not used 2 7 6 DEVICE CHECK This option allows checking the communications serial channel operation For this purpose it is necessary to connect the spirometer to the computer and press the key START Next verify that the information is transferred so no error window must appear that case verify the interconnection and the option LINKS of the device setup Device Check for DATOSPIR 600 When there is a DATOSPIR 600 linked with the software this option permits checking the correct performance of the equipments electronic parts in the next characteristics as shown in the picture 511 BLO MU2 REV 1 06 Ey 2727 227229 SIBELMED W20s User s Manual 38
34. displayed i Save the test 511 BLO MU2 REV 1 06 NODE s S be 11ec SIBELMEDW20s User s Manual pna ANNEX 2 MAXIMAL PRESSURES TEST OPTION 511 BLO MU2 REV 1 06 Tika Ey 2727 22 229 SIBELMED 205 Users Manual 141 A2 1 INTRODUCTION The maximal pressure module has been designed in collaboration with the Laboratory of Pulmonary Function of the Hospital de San Pablo of Barcelona It is based on the criteria expressed by J L Clausen to the Thoracic Society of California It enables a measurement range of 295 hPa 300 0 inspiratory and expiratory tests It has several reference values available to be set up by the user A2 2 MAXIMAL PRESSURES PROGRAM Next the options of the maximal pressure program are displayed e Patient Data Name and surname Date of birth and sex Address telephone occupation and comments e Test Data Patient name and code Size and weight Motive origin technician and comments e Maximal pressures setup Initial time Referenc es Colors e Patient change e Start of maneuver e Change of MEP and MIP or vice versa 511 BLO MU2 REV 1 06 co Se S be 117eC SIBELMED W20s User s Manual 142 e Selection of maneuver e Delete the selected maneuver e Store in the data base e Report performance e Zoom Zoom and organize windows The operative windows enable the maneuver display and the whole test data These are the follow
35. it up between O 1s and 4 9 s This delay time affects the measurement calculation so no value within the first second or the value set up by the user is taken into account Select one of the three color sets for the drawing of the memorized curves A2 4 MAXIMAL PRESSURES TEST PROCEDURE To enter the Maximal Pressure test you must press over the Maximal Pressure icon from the main menu 511 BLO MU2 REV 1 06 Tt ae S be 1N7e SIBELMED W20s User s Manual 144 A2 4 1 INPUT OF PATIENT AND TEST DATA If the patient and test data have been previously entered the program will directly go to the Maximal Pressure Test screen considering the previous data If there is no active patient the program will show a dialogue box to enter the data Consult DATA BASES PATIENT CARD section in the general manual After pressing OK in the Patient Card the program will show a new dialogue box like the one displayed next to enter the test data Consult PROCEDURE FOR FVC ENTERING PATIENT AND ENVIRONMENTAL PARAMETERS section in the general manual E x Day Month Year Time Reference 22222221114 2o Jos 2010 09 45 Name Francisco Smok Surname 000 Cigarr d Height ca 80 Weight Kyy 7 23 1 Normal weight Temp 00 FI His Motive Procedence Technician EChrnic References MORALES Comments
36. law is described AN IMPORTANT WARNING According to current legislation the software s user is solely responsible for the storage and treatment of their patient data in accordance with the law Observance of the recommendations included in this section does in no case guarantee the full adaptation of user activity to the standards relating to data protection Requirements which specifically affect the use of the SIBELMED W20s Spirometry Software Identification and Authentication The processes for user identification and authentication for use of the SOFTWARE W20s are performed by the PC s operating system Therefore only Windows Operating Systems which allow the performance of said processes in a secure way are valid i e Windows 2000 Windows XP Windows Vista and Windows 8 with an NTFS file structure Windows 9x systems or FAT file structures are not valid 511 BLO MU2 REV 1 06 S eat A SIBELMED W20s User s Manual 171 The PC administrator must create a unique and personalized identification for each user and activate authorization verification The operating system saves the passwords in an unintelligible way Access control The Operating System must be set up to control the access to data i e permit or deny access to data Likewise the PC administrator must set up the user account lock in order to impede reiterated attempts for unauthorized access Consult the manual for the operating syst
37. must be installed in the computer to allow communications with the equipment A The installation of the Bluetooth device on the computer may vary according to the device brand and according to the operating system that it is installed on 511 BLO MU2 REV 1 06 at ae S e N7C7 SIBELMED 205 Users Manual 22 Consult the INSTALLATION MANUAL FOR BLUETOOTH ADAPTER provided with the Bluetooth module of each SIBELMED spirometer and the User s Manual of each Bluetooth adapter 2 4 4 USB DRIVER INSTALLATION For USB compatible spirometers a driver needs to be installed on the computer This driver is installed automatically during the installation of the W50 software To perform this process simply disconnect the USB cable from the computer install W50 software and plug in the USB cable with the audiometer switched on From this moment the driver is installed and you can start communications with the device Note in Windows XP it is necessary to select the automatic installation option when the found new hardware wizard screen appears In addition to the automatic procedure it is possible to install the driver manually To perform this follow these steps 1 Start up the spirometer Consult the corresponding manual for use 2 Insert the W20s Installation CD into the computer Case of Windows 98 2000 XP 7 8 3 Connect the spirometer to the computer with the USB cable Consult the corresponding manual for u
38. option in the menu the screen shows the selected data base and allows selecting another one exploring any directory in the computer When confirming the data base it asks for a PASSWORD which must be the one introduced when it was created if no password was assigned it will patch in directly Moreover clicking on the Data Base button allows creating a new data base in the selected directory To do so the name of the base i asked and when confirming it it asks to enter a PASSWORD and a reconfirmation of it Clicking on the Delete button allows erasing the data base selected To do so it asks for the PASSWORD must be the one defined when it was created 511 BLO MU2 REV 1 06 a ea SIBELMED W20s Users Manual 55 When deleting a data base all the patient registers and the graphics parameters or any other information in it gets erased and cannot be recovered The following steps must be performed for exchanging the data bases in CSV format EXPORT gt TRANSPORT gt IMPORT A EXPORT Use the option Export to format CSV in the remote PC to store the tests to be explored in the local PC as indicated in the previous paragraphs The tests will be stored in the selected file and directory A file called GRAFxxx CSV will be also stored usually GRAF001 CSV B TRANSPORT These files will be sent by e mail or transferred through an interchangeable disk or floppy disk to the local path C IMPORT Exe
39. patient s code without initializing the data fragments of signals will be stored one after the other until a maximum of eight hours The device interprets that all the fragments belong to the same patient and the calculation of parameters will be made with the whole memory If you want to perform the test with other patient change the patient s data entering the menu option or pressing the corresponding key fasPIROMETRY SOFTWARE SIBH Setup Options Help Start Maneouvre Test data Reset data mm Test Data Save test Report Setup Options Help Organise windows If the thimble probe is disconnected the signals of SpO2 and PR will be presented with 0 value These periods of time will not be taken into account when calculating the parameters and the duration of the study 511 BLO MU2 REV 1 06 DU NEUE RE S S be iN7eC SIBELMED W20s User s Manual 137 1 5 3 PRINTING AND OR SAVING IN THE DATABASE A PRINTING OF THE RESULTS At any moment you can enter the option report from the pulse oximetry tests screen Setup Options Help Setup Options Help Start Maneouvre 2 Reset data Test Data Change Patient Save test Organise windows If the parameters have not been calculated because the thimble probe has not been applied during the study or because no study has been performed the following message will be displayed Manoeuvres Othe
40. performing spirometric tests 2 9 1 ENTERING PATIENT AND ENVIRONMENTAL PARAMETERS The connected spirometer must have the menu Spirometry selected Select OPTIONS Spirometry in the Main Menu or activate directly the icon corresponding to the patient performing a spirometric maneuver the next screen appears 511 BLO MU2 REV 1 06 M Em SIBELMED 205 Users Manual 57 iix Emen n Spromety Mens concen Select the option SPIROMETER OPTIONS NEW PATIENT or activate directly the icon Patient Next enter the number of Patient Reference if he is new in the Data Enter Base and the Reference or Surname if patient exits In the first case after pressing OK the Patient Card appears which must be completed with the convenient data At least they must be Reference Date of Birth The age is calculated automatically and Sex for the later availability of the Spirometric Predicted Set In order to fill each of the fields place the cursor with the mouse in the wanted field In order to advance use the tabulation key but not the ENTER or RETURN as it is the same as pressing OK and exit the card Once the card is filled in press OK 511 BLO MU2 REV 1 06 Wier SIBELMED W20s User s Manual 58 a nyw potet When performing a spirometric test it is necessary to enter certain data related to the patient to the environment or others that vary from o
41. 1 0 MAXIMUM PRESSURES REPORT maxIP maxEP 1 166 203 2 0 0 M3 0 0 4 0 0 M5 0 0 Avegage 166 203 Std Dev 0 0 Reference 141 217 Maneuver 118 93 Average 118 93 Comments 250 50 200 100 150 150 100 200 50 250 cm H20 0 20 09 2010 Time 10 59 Height cm 180 Wgt Kg 75 Humidity Smok I BMI 23 1 Transducer Demo SIBELMED W20s cm H20 5 SAVING IN THE INTERNAL DATA BASE The following window will appear where you can choose the maxIP and maxEP curves to store in the data base The results of all the maneuvers will be stored indifferently of the selected curves 511 BLO MU2 REV 1 06 a ea S be 77CC SIBELMED W20s User s Manual 156 22 Cations e Setup Options Maneouvres Help Start Maneouvre D Test Data ee c j gt Change Patient 5 Change to Pim Report 250 E OR Zoom Zoom Organise windows 7777 77 77 The test is stored in the internal data base of the device Then it can be displayed printed and or transferred to a computer The following message window will confirm that the test has been correctly stored Save the test 511 BLO MU2 REV 1 06 72 5 SIBELMED W20s User s Manual ANNEX 3 BRONCHOCONSTRICTION TEST OPTION 511 BLO MU2 REV 1 06 7 et aA
42. 1400 219 Memory4 EM MemoryS M5 511 BLO MU2 REV 1 06 Ey 2727 22 7 279 SIBELMED 205 Users Manual 152 To select a different memory MEP perform also the step 2 previously making sure that the expiratory procedure is activated after step 1 To delete a maneuver first select it and then enter the menu option Maneuvers Delete The following window will appear which will enable to confirm the deleting LL xi 2 YOU CRLTING ARE YOU ARIT Window of memory display It is a complementary window to the Summary window It is activated when some of its Check boxes are selected It enables to display in one axis of time the superimposed graphics of the chosen maneuvers and adjust the graphics to the desired size 1111111111 ni om marl mask 250 cm H20 Bii 23 1 M2 233 219 Awegagr 218 Std Dev 4 Reference Manoeuee amp Awerage Reference P MORALES 511 BLO MU2 REV 1 06 S be 17e SIBELMED W20s User s Manual 153 It is useful for the comparison of the maneuver form and to observe the difference between the instants when the values of maximal pressure took place NOTE Remember that with the RET key or with the option of the Setup Exit menu it is possible to go back to the previous scr
43. 6 003 3333333333 Marcos Fernandez Juan 003 20 09 2010 10 30 FYC 1 24 004 4444444444 Mir Perez 004 20 09 2010 10 37 vos 005 5555555555 Ramos Garcia Pedro 005 20 09 2010 10 42 905 006 6666666666 Pardo Miret Jos 006 20 09 2010 10 48 MY vos 007 20 09 2010 10 59 MW vos 008 27 10 2010 12 25 SP02 0 0 1 Mark the tests to be exported 2 Press the EXP icon or select the option Export to Disk from the Options menu Next the window Export File Definition Clicking with the mouse s right button over one test menu appears with the next options 511 BLO MU2 REV 1 06 CER ERU 5 SIBELMED W20s User s Manual 54 DELETE it allows deleting the test RECOVER it allows recovering the test if it is marked to be wiped Double clicking over a test makes the tests window appear 3 Enter the name of the file that is going to store the data and the folder where to be saved 4 a Press the Accept button to perform the export At this moment the file has been created OR b Press the Cancel button to get back to the previous screen without performing the export 2 8 5 IMPORT TESTS IN CSV FORMAT The export module in combination with the import module enables the exploration in the local consult of the tests performed in a remote consult Both consults must have the spirometry software SIBELMED W20s available DATA BASE SELECTION When selecting this
44. CE 1 To activate this product it is necessary to use the key which is the label of CD once that the software is activated lt gt 2 If you already have the software and the version is previous than 3 00 you should ask for the activation key to your distributor or to Sibel 5 4 before you update the software It is necessary to indicate the spirometer s serial number InstallShield 5 To print reports in PDF format you must install the PDFCreator application choosing the installation options that are displayed in the following screens Note The application Adobe Reader only allows viewing PDF files not to print them 511 BLO MU2 REV 1 06 i Setup PDFCreator b rge org 511 BLO MU2 REV 1 06 Welcome to the PDFCreator Setup Wizard This will install PDFCreator 1 6 2 on your computer It is recommended that you close all other applications before continuing Click Next to continue or Cancel to exit Setup Expert settings Set server mode installation directory and additional options D a a a SIBELMED W20s Users Manual Setup PDFCreator 5 xi License Agreement PDF Please read the following important information before continuing Please read the following License Agreement You must accept the terms of this agreement before continuing with the installation PDFCreator About PDFCreator With PDFCreator you
45. ELMED W20s Spirometry Software has been developed by the R D I department of SIBEL S A with the collaboration of the Lung Function Laboratory of Hospital de la Santa Creu i Sant Pau de Barcelona in line with the standardization criteria of International Institutions ATS ERS TASK FORCE 2005 American Thoracic Society European Respiratory Society National Institutions SEPAR Spanish Pneumology and Thoracic Surgery Society COMPLIANT PRODUCT C 0197 2 Medical Device Directive Class IIa Revised Approved Date 2014 05 Date 2014 05 Technical Manager Sales Manager 511 BLO MU2 REV 1 06 SIBELMED W20s User s Manual lU 1 SAFETY 511 BLO MU2 REV 1 06 cf SIBELMED W20s User s Manual 9 1 1 SPECIAL PRECAUTIONS The SIBELMED W20s spirometry software has been designed for use with the safety in mind All operating instructions must be read before using it Failure to do so could cause injury to the user or patient and damage to the equipment and or accessories This spirometry software can be used in conjunction with several spirometers manufactured by SIBEL S A It is very important to carefully read the User s Manual of the spirometer before using it with the software especially the SAFETY section where all the safety considerations related to the spirometer are explained in detail 1 2 INTENDED USE The W20s software when is u
46. ERS of the Setup Menu The asterisks appearing in the graphic F V are equal to the patient Reference values for the parameters FVC MEF25 MEF50 MEF75 and PEF These indications only appear if the Reference values exist The PEF is placed at 10 of the FVC Reference volume INCENTIVES The incentive is a graphic possibility useful for motivating children during the performance of spirometric maneuvers of FVC This option can be activated or deactivated by entering SETUP GRAPHICS AND OTHERS as well as by selecting among different pictures besides a Sound Warning It is convenient for technician who is performing the tests of forced spirometry to know the usual procedure required If not so it is recommended to check some indications related to it In the performance of the spirometry the following steps must be taken into account 1 Verify that the spirometer is connected to the computer and setup correctly 511 BLO MU2 REV 1 06 ey aay A SIBELMED W20s User s Manual 66 2 Train the patient about the test performance as his collaboration is essential for its correct proceeding The patient can perform the maneuver in two different ways e The first consists of starting the maneuver over the transducer with the FORCED ESPIRATION followed by the FORCED INSPIRATION if needed e The second consists of the patient breathing normally through the transducer and when the technician indicates it fi
47. LMED W20s PARAMETER OBS REF 1 144 01 175 70 82 44 36 l min 300 2 12 BRONCHODILATION TESTS Spirometry Software SIBELMED W20s offers the possibility of making Postbronchodilation tests in Forced Vital Capacity FVC mode Slow Vital Capacity VC and Maximum Voluntary Ventilation MVV The purpose of this operation mode is to have in the same report the spirometric results before PRE and after POST the application of a bronchodilator substance in order to compare them The procedure to make the Postbronchodilation Spirometry Test is the following 1 Perform a FVC VC or MVV test according to the previous sections Store the best maneuver in Prebronchodilation mode as described in the Maneuver Data subsection of the FVC 511 BLO MU2 REV 1 06 T 5 SIBELMED W20s User s Manual PROCEDURE section 2 Apply to the patient a dose of bronchodilator medicine which the doctor determines If you want tests with other patients can be inserted as the Prebronchodilation test data remain in the computer memory 3 Press the DILAT icon to enter the next screen 4 Select the Prebronchodilation with which the POST data will be compared Press OK When saving a PRE maneuver when using the disposable transducer it also saves the Transducer Calibration Code and it is recovered in the POST maneuver TisPIROMETRY SOFTWARE SIBELMED W20s D
48. LSE OXIMETRY OPTION TESTS AND PARAMETERS The spirometer allows performing lone measurements or long duration ones For both lone studies or long duration studies the next parameters can be calculated 90 80 CT70 e IDH 4 IDH 3 IDH 2 e SpO2 Max e SpO2 Medium e SpO2 Min SpO2 Std PR Max PR Medium PR Minimum PR Std Test Time 511 BLO MU2 REV 1 06 of the time in which the SpO is under 90 of the time in which the SpO is under 80 of the time in which the SpO is under 70 index of desaturations gt 4 per hour index of desaturations gt 3 per hour index of dessaturations gt 2 per hour maximum value of the Saturation medium value of the Saturation minimum value of the Saturation standard deviation of the Saturation maximum value of the pulse rate medium value of the pulse rate minimum value of the pulse rate standard deviation of the pulse rate time of use of the test the finger probe unplugged time is not count A p Ey 27 7 227 277288 SIBELMED W20s User s Manual 121 RANGES AND MEASUREMENTS DATOSPIR 120 110 Measurement Range SpO2 Pulso BPM 0 100 0 250 meam a p 60 70 el mayor de ambos DATOSPIR 600 Measurement Range pe 9 o Pulso BPM 100 0 250 E I Resolution 70 a 100 262 60 a 70 i 5 the largest of both DATOSPIR MICRO Measurement Range pia Pulso BPM 100 0 250 Resolution 70 a
49. MED W20s always stores all the parameters of the different spirometric tests Nevertheless the selection made here affects only the screen presentation or in the printed reports PARAMETERS AND OTHERS UNITS Select the option PARAMETERS AND OTHERS UNITS and the units you want to work 511 BLO MU2 REV 1 06 ae a S be 117CC SIBELMED W20s Users Manual 32 PARAMETERS AND OTHERS HEADER REPORT Select the option PARAMETERS AND OTHERS HEADER REPORT into SETUP In the printed report a three line header can be inserted with the data selected by the user For example Name of the Centre Doctor Address etc This header will remain as long as it is not modified 2 7 3 GRAPHICS PEDIATRIC INCENTIVES AND LANGUAGE SELECTION Select the option GRAPHICS AND OTHERS inside the SETUP Graphics and Others Graphic Report Screen Graphics Curve F V Curve V T M Curve F V Curve VC Curve Curve V T Large Graphs in Report Data B Graphics Print 3 Best Curves v TEBE prapnicy Print 3 Best Maneuvers Savang Eest Maneuvers Invert VC curve Incentive Language 1 Test Predicted 100 1 English m Activated 100 9 Es Other Test of the Best Rocket Sound Warning 8 9 This option allows the user to select the following 511 BLO MU2 REV 1 06 ey ear A SIBELMED W20s User s Manual 33 e Graphics in the Print
50. PACK Check DATA BASES DATA BASE MAINTENANCE 511 BLO MU2 REV 1 06 a 5 SIBELMED W20s User s Manual 48 OPTIONS TEST DATA This screen presents the Test Data performed to the patient in the date and time indicated in the same card Test Data A Options Mont Day Year E Code 34 05 fos 2014 Alerts ATS ERS PARAMETER ACT PRED PRED EX 1 6 2 Best FEVl 1 4 26 4 31 99 3 BFevl BFvc 71 00 79 11 0 4 1 6 00 5 31 113 5 0 5 1 2 76 Emm 6 FEVl 1 4 26 4 31 Cough er re 9 t ELSE 90 l2 PEF 1 5 6 60 10 06 66 Wheezing 14 50 1 5 3 77 5 30 ual 16 25 75 1 5 3 41 4 24 80 Dyspnea 20 50 50 1 00 0 66 152 21 MTT 5 0 82 Sputum C 22 0 5 1 55 1 45 107 23 FEV1 PEF 8 10 77 6 64 162 xl status 000343 000349 L4 n A The following options are allowed Delete deletes all the information related to this test Restore allows restoring a deleted test Test Datl presents the information related to the test Graphic displays the graphic corresponding to the test Report allows making a report of the test Export exports the test in the files PRUEBAS CSV and GRAFOO1 CSV by default in the folder C ESPWIN TMP 511 BLO MU2 REV 1 06 D ee 5
51. PRESSURES CONFIGURATION 142 A2 4 MAXIMAL PRESSURES TEST PROCEDURE 143 A2 4 1 INPUT OF PATIENT AND TEST 144 A2 4 2 PERFORMANCE OF MAXIMAL PRESSSURE TESTS 145 A2 4 3 PERFORMANCE OF SNIFF TESTS renti 147 A2 5 TEST INFORMATION 148 A2 5 1 WINDOWS DESCRIPTION SELECTING AND DELETING MANEUVERS ana Rd ES 148 A2 6 PRINTING AND OR SAVING IN THE DATA BASE 153 ANNEX 3 ernissnnu raa ne RREERSERRRRERESRERRRERRSNARRNERASERARNRRANARRFREENNS 157 BRONCHOCONSTRICTION TEST OPTION 157 A3 1 BRONCHOCONSTRICTION TEST PROCEDURE 158 511 BLO MU2 REV 1 06 SIBELMED 205 Users Manual 6 AS TESI DESCRIPTION 3 060 cnscncdatastenunieedinaincineatonvnede 158 A3 1 2 INPUT OF TEST 556 ine f ness 160 A3 1 3 PROCESS OF THE TEST 5 iret 161 A3 1 4 SUMMARY PRINTING and or SAVING OF TEST 167 ANNEX 4 169 COMPLIANCE WITH THE DATA PROTECTION DIRECTIVE 95 46 169 4 1 COMPLIANCE WITH THE DATA PROTECTION DIRECTIVE 95 46 170 511 BLO MU2 REV 1 06 DU ERU S be 1N7e SIBELMED W20s User s Manual 7 SIB
52. S Version 16 1 i s 11111111111111111111 L pez Garcia Francisco Male Age y 25 Pres mmHg 760 SEPAR SPAIN 1 086 511 BLA 1 05 PRE POST 511 BLO MU2 REV 1 06 S be 77CC SIBELMED W20s User s Manual Date N 09 05 2014 11 28 Height cm 175 Wgt Kg 76 Humidity 65 1 BMI 24 8 Transducer Disk Ethnic F 100 PRE POST 2 4 6 8 1012 14 16 18 20 22 24 DU Ne SIBELMED W20s User s Manual 83 2 13 IMPORTING TESTS FROM THE SPIROMETER When activating the icon BATCH or the option Importing Tests of the Main Menu the following screen is presented NO REFERENCES No Reference Typo Pl P2 Date Time 1111111111 FVC 4 26 20 09 2010 10 20 00 0002 1111111111 5 46 3 89 20 09 2010 10 25 00 0003 1111111111 FVC 1 24 0 92 20 09 2010 10 30 00 0004 1111111111 3 72 0 77 20 09 2010 10 37 00 0005 1111111111 VC 3 35 1 11 20 09 2010 10 42 00 This option allows to transfer or import tests which are stored in the spirometer DATOSPIR TOUCH DATOSPIR 120 DATOSPIR MICRO or other compatible to the computer Data Base The process to follow is this 1 Connect the spirometer to the computer serial port 2 Verify that the spirometer is turned on 3 Select the tests to be transferred with the mouse if they ar
53. SIBELMED W20s SPIROMETRY SOFTWARE USER S MANUAL Sibelmed 511 BLO MU2 REV 1 06 e 2014 05 Si be med Sm EERP SIBELMED 205 Users Manual 2 SibelEs SIBEL S A Rosell n 500 bajos 08026 Barcelona Spain National Sales Tel 93 436 00 08 e mail comercial sibelmed com International Sales Tel 34 93 436 00 07 e mail export sibelmed com Technical service Tel 34 93 433 54 50 e mail sat sibelgroup com Fax 34 93 436 16 11 Website www sibelgroup com SIBEL S A belongs to SIBELGROUP 511 BLO MU2 REV 1 06 ETE REA Ey 2727 22 279 SIBELMED W20s Users Manual 3 TABLE OF CONTENTS 8 1 1 SPECIAL PRECAUTIONS 9 1 2 INTENDED 6 9 1 3 INTENDED PATIENT 10 1 4 USER PROFILE ccccssccncccrsccnnsccurscceuceuscceuseceusecencauss 10 1 5 EFFECTS ON PATIENTS USING THE SPIROMETRY SOFTWARE 10 2 12 2 1 INTRODUCTION 13 2 2 PREVIEW 13 2 3 MANUFACTURER S LIABILITY 15 2 4 INSTALLATION AND
54. ata Base sibel ioj Setup Options Help 2 4 6 8 1012141618202224 Shows data of performed manoeuvres 5 Then proceed as described in ENTERING FORCED VITAL CAPACITY TESTS subsection of the FVC PROCEDURE section 511 BLO MU2 REV 1 06 cy L37277 22722228 SIBELMED W20s User s Manual fisPrroMetry SOFTWARE SIBELMED W20s Data Base sibel 5 xi Setup Options Help e dw De OC LIC Manoeuvres Summary Reference 1111111111 Lopez Garcia F PARAMETER pa M2 5 6 a 5 00 5 99 17 a 4 57 4 26 PEE fs 9 87 6 50 41 FEE25 75 l s 5 69 Graphic DA Leu 2 4 6 8 1012141618202224 6 If the printed report is required the data are presented in a similar way to the displayed next 511 BLO MU2 REV 1 06 eee 511 BLO MU2 sibel sibel sibel ID Code 11111111111111111111 Date Name L pez Garcia Francisco Sex Male Age y 34 Temp 9C 25 Pres mmHg 760 Reason Procedence Technician Predicted SEPAR SPAIN F BTPS 1 086 Version 511 BLA 1 05 FVC REPORT Maneuver No 1 PRE POST PARAMETER 1 PRED PRED 1 Best FVC 1 6 00 113 5 31 5 00 Best FEV1 1 4 26 99 4 31 4 58 1 71 00 90 79 11 91 54 FVC 1 6 00 113 5 31 5 00 0 5 1 2 76 3 52 FEV1 1 4 26 99 4 31 4 58 FEV3 1 5 86 4 99
55. ataBases Options Window Help Fa O z L3 Reference Date 1111111111 Lopez Garcia Francisco 20 09 2010 2222222222 Sanchez Grau Maria 20 09 2010 3333333333 Marcos Fernandez Juan 20 09 2010 4444444444 Perez 20 09 2010 5555555555 Ramos Garcia Pedro 20 09 2010 6666666666 Pardo Miret Jos 20 09 2010 20 09 2010 27 10 2010 By entering this option the program opens the exploring window The window Patient Maneuvers on the right in the image below is complementary to the window Patients Only the tests of the selected patient will appear in the window Patient Maneuvers 2 14 1 ORGANIZATION OF THE WINDOWS You can remodel the windows by pulling its edge with the cursor following pictures Vertical Mosaic 2222222222 3333333339 4444444444 5555555555 6666666656 511 BLO MU2 REV 1 06 a NEN 5 SIBELMED W20s User s Manual Horizontal Mosaic 86 F 002 2222222222 4 Grau Maria 3333333333 Marcas Fernandez Juan 4444444444 Mir Perez Anna 008 5555555555 Ramos Garcia Pedro 006 6656656566 Pardo Mirct Just Cascade T 002 2222222222 Sanchez Grau Maria 00 3333333333 Marcon Femandez Juan 004 4444444444 Mir Perez Anna r amos Garcia Pedro f F 006 6666666666 Pardo Miret Jos r a NOTE If you enter the export mod
56. aturation measurement etc The spirometer calculates statistical parameters for the reading of SpO PR as well as the desaturation Index per hour IDH4 IDH3 and IDH2 the percentage of desaturations under some value CT90 CT80 and CT70 the standard deviation the mean and the maximum and minimum values It is possible to print the parameters store them in the data base export and import them 2 PULSE OXIMETRY PROGRAM Next the different options of the pulse oximetry program are shown e Patient Data Name and code of the patient Fate of birth and sex Address telephone occupation and comments e Test Data Name and code of the patient Size and Weight Motive origin technician and comments e Pulse Oximetry configuration Acoustic signals Average 511 BLO MU2 REV 1 06 a ea SIBELMED 205 Users Manual 130 e Start of the maneuver e Data of the maneuver e Initialize the data e Test Data e Change of patient e Store the test e Report e Organize Windows The operative windows allow the display of the pulse oximeter values follow the evolution of the perfusion waveform hear the acoustic signal and display the calculated parameters They are the following ones e Pulse Oximetry Window e Data Window A1 3 PULSE OXIMETRY CONFIGURATION It is recommended that any user configures the pulse oximetry module according to their needs The pulse oximetry configuration menu i
57. bility of each For each parameter a range of values is defined maximum and minimum and these values are represented in the graphic with a green line and with other red line in order to identify clearly when these limits are surpassed When a variability graphic is selected this is represented through percentage the variation between A M and P M of the selected parameter The calculation of the variability value is defined in this way 100 A M Value P M Value A M Value The tests being made from Oh until 12 00h are considered to be performed during the A M and the ones being made from 12 00h up to Oh are considered to be performed during the P M In the chapter Display Report allows to make reports for the details in numeric form graphic or both numeric and graphic simultaneously 511 BLO MU2 REV 1 06 5 SIBELMED 205 Users Manual 46 See 2 8 2 EXPLORE DATA BASE fisPIROMETRY SOFTWARE SIBELMED W205 Data Base sibel E O x Setup Data Bases N Reference Name l m 20 09 2010 002 2222222222 Sanchez Grau Maria 20 09 2010 003 3333333333 Marcos Fernandez Juan 20 09 2010 004 4444444444 Perez Anna 20 09 2010 005 5555555555 Ramos Garcia Pedro 20 09 2010 006 6666666666 Pardo Miret Jos 20 09 2010 Options Window Help 22 20 09 2010 27 10 2010 12 25 SP02 This window allows viewing the data base patient s list with the
58. ble W20s 2 4 INSTALLATION AND SETUP 2 4 11 SPIROMETRY SOFTWARE INSTALLATION A If the software is going to be installed under Windows NT 4 Windows 2000 Windows XP Windows Vista Windows 7 or Windows 8 operating systems the user must have Administrator rights to be able to install all the program s features In case of any doubts contact your System Administrator or check the help of the Operating System For the Software installation in PC hard disk media you should proceed as follows 1 Introduce the CD in the CD ROM reading unit 2 Ifthe PC s CD ROM unit has the auto run option enabled it will run to the automatic installation otherwise the program Setup exe should be executed after acceding to the corresponding CD_ROM unit 3 Once installed it will appear the next window which permits to choose the installation process language 511 BLO MU2 REV 1 06 Sibelned _ Elegir idioma de instalacion x Seleccione uno de los idiomas siguientes parala instalaci n 4 Please choose the directory where to install the program and the group of programs name The program s default installation directory is C SIBEL W20s SPIROMETRY SOFTWARE SIBELMED W20s x Welcome to the installation of SPIROMETRY SOFTWARE SIBELMED W20s 7 SPIROMETRY SOFTWARE SIBELMED W20s will be installed on your computer To continue click 5 RES ers e IMPORTANT ADVI
59. c factor modifies the Predicted values according to the selected percentage If no correction is to be included the factor must be 100 e Comparing mode in the Bronchodilator Tests Average between PRE and POST 100x2 POST PRE POST PRE between REF and POST 100 POST REF between PRE and POST 100 POST PRE PRE Difference between PRE and POST POST PRE The second comparison mode between REF and POST is fixed and is always shown independently of the mode selected 511 BLO MU2 REV 1 06 Sy a S be 177C7 SIBELMED W20s User s Manual 31 e Alerts If this option is activated the report will show some indications about the quality criteria according to ATS ERS ET EX or according to NLHEP ET EX PEFT as well as symptoms that have experienced the patient during the test Cought Weezing Dyspnea Sputum e Calibration F When activated shows the date of the last calibration in the report Quality control Spirometry Software SIBELMED W20s incorporates automatic quality control function based the recommendations of the National Lung Health Education Program NLHEP with prompts and grades to assist the technician in providing the good instructions to the patient to produce high quality spirometry tests See the QUALITY OF FVC TEST section in the TECHNICAL SPECIFICATIONS chapter for a detailed explanation of QC prompts and QC grades The Spirometry Software SIBEL
60. ccess Database accessed Action carried out on the database Type of access authorized or denied File path of database accessed Reference of the register accessed The format of each of the lines is the following USER YYYYMMDD HH MM SS BASE ACTION ACCESS PATH REFERENCE 511 BLO MU2 REV 1 06 eet a a SIBELMED W20s User s Manual 175 The database is comprised of a directory and two data files patients dbf and tests dbf as well as auxiliary files indexes etc The actions to be registered are divided into e Action on the actual database itself open close delete etc e Action on the registers stored on the patients dbf and tests dbf data files insert consult delete etc In any event the register or access control log file must be kept for a minimum period of two years Below all actions registered on the log file are listed e Opening a db file e Closing a db file e Selecting a db e Creating a db e Creating a db file e Deleting a db e Deleting a db file Re indexing a db file e Wrapping a db file e Changing access password Consulting the register Adding a register Marking a register Recovering a register e Changing a register e Deleting a register Exporting a register Importing a register 511 BLO MU2 REV 1 06 D eat A S belmed SIBELMED W20s User s Manual 176 Other important subjects Printing documents
61. cute the CSV import process as indicated below Enter the option lt lt Database Import test CSV format gt gt in the main menu Choose the directory and the csv file you want to import The following window appears Data Import Data Base D SIBEL W20s Bdsibel sibel E NO REFERENCES No Reference Typo Pl P2 Date Tine 0001 1111111111 FVC 5 98 4 26 20 09 2010 10 20 00 21 0002 1111111111 FVC 5 46 3 89 20 09 2010 10 25 00 0003 1111111111 FVC 1 24 0 92 20 09 2010 10 30 00 0004 1111111111 VC 3 72 0 77 20 09 2010 10 37 00 0005 1111111111 VC 3 35 1 11 20 09 2010 10 42 00 E EL E TT It shows the tests stored the file PRUEBAS CSV Click with the mouse over the tests to be imported to the data base of the spirometry software SIBELMED W20s or 511 BLO MU2 REV 1 06 ooo paa eat A W20s User s Manual 56 click over the key S AII in order to select all the tests Click on the OK button The program will show the percentage of the import until it is done 2 9 FORCED VITAL CAPACITY FVC TEST PROCEDURE The procedures to be used for the spirometric test of Forced Vital Capacity FVC Slow Vital Capacity VC and the Maximum Voluntary Ventilation MVV as well as the Postbronchodilation DILAT mode are very similar Only a detailed explanation will be made at this point A use of bacterial filters is recommended for
62. d maneuver will be deleted M1 provided that this is not the best If this were the best maneuver then the second one would be deleted M2 Once the corresponding maneuver has been deleted the system will reorder them and the performed maneuver will be M5 the M5 will be M4 the M4 will be M3 and 50 on D Selecting and deleting maneuvers The value of the selected maneuver is shown in bold type to indicate that it will be used in certain actions specially to delete it through the menu option Maneuvers Delete to store its curve in the data base and to represent its curve in the report Check Printing and or memorization in the data base 511 BLO MU2 REV 1 06 Ey 2727 22 2790288 SIBELMED W20s Users Manual 151 By default the program automatically selects the best of the maneuvers alti at To select a memory maxIP different to the best 1 Make sure that the inspiratory procedure is activated through the icon MEP MIP or the menu option Options Change to MIP the axis of time in the window Best maneuver must be in the upper part 2In the menu Maneuvers Select click on the desired maneuver or in the window Summary click with the cursor over the maneuver to be selected within the area limited by the emphasized rectangle as indicated next Maneouvres Help maxlP Select 1 203 Delete wv Memory2 EBM 233 _Memory3 NB
63. d pressing the mouse left button Next do the same over the label PRINTER SELECTION Configurar impresion 2 Impresora Nombre 45 Propiedades Estado Listo Tipo Snaglt B Printer Ubicaci n SNAGITG Comentario Papel Orientaci n Tama o Vertical Origen Selecci n autom tica 7 Horizontal Red Cancelar screen shows the printer selected by the operative system as well as the available printers at that moment If the printer in use is not found in the relation it is necessary to install it using the process defined by the system Consult the computer Operative System Manual 2 7 2 PARAMETERS INTERPRETATION AND PREDICTED SETS PARAMETERS AND OTHERS SELECTION 511 BLO MU2 REV 1 06 Ey 2727 22 279028 SIBELMED W20s Users Manual 29 Select the option PARAMETERS AND OTHERS SPIROMETRY inside the SETUP Select Parameters and Others FVC Parameters 25 75 s FIVC 1 v MVV Ind l min rFEVO 5 2 1 5 7 100 s 4 FEVE 13 FEVL l 5 l s 50 50 FIVI FIVC t FEVI FEV6 1 FEFSOs 1 5 MTT FEVI FIVl t COPD index 5 0 5 t 25 l s FEVL FEVO 5 PIF l s Lung Age FEVl FVC 25 75 1 s v FEVI PEF PEF
64. e 4 Press the key IMPORT to transfer The screen presents the following information Nr Number of test order Reference Corresponding to the patient 511 BLO MU2 REV 1 06 a ee S be 1N7eCC SIBELMED W20s User s Manual 84 Type Corresponding to the type of test being FVC Forced Vital Capacity VC Slow Vital Capacity MVV Maximum Voluntary Ventilation Dilat Postbronchodilation Test in FVC mode P1 and P2 Parameters corresponding to 1 2 FVC FEV1 vc VC VT MVV MVV Breath min Dilat FVC pre FVC post Date and Time Performance of the test Each test transfers all the available parameters The two previously mentioned are approximate for the user The information transferred is stored in the operative Data Base at that moment and in each corresponding patient card 2 14 EXPORT OF TESTS TO OTHER SYSTEMS This program module allows the export of tests to format delimited by inverted comas files with extension CSV so that they can be read by other systems You can enter this module from the main menu option Data Bases Export Tests Format CSV lt SOFTWARE SIBELMED W20s Data Base sibel Setup Data Bases Options Help Patient Explore Data Base Maintenance Export tests 5 Format Import tests CSV format 511 BLO MU2 REV 1 06 S be 77CC SIBELMED W20s User s Manual T SPIROMETRY SOFTWARE SIBELMED 205 Data Base 5 x Setup D
65. e Access to Product Activation A dialogue box appears in which the activation code must be typed This will register the device and the DEMO mode will be deactivated 2 18 UPDATE OF THE DEVICE S SOFTWARE The DATOSPIR spirometers from SIBEL S A have an updating and software maintenance process resident inside themselves To update the version of the software follow these instructions D120 D110 MICRO and TOUCH spirometers Check the corresponding User s Manual for each Spirometer 511 BLO MU2 REV 1 06 i A 5 SIBELMED W20s User s Manual D600 To update the version of the D600 internal software the option Setup Utilities Update Flash should be selected The next screen will appear DATOSPIR Update x d sibel w20s firmware Program 00 Examine Port Speed 19200 Serial a Q 0 Check that the device is and connected to the computer Check if the selected port and the velocity of transmission are correct If not proceed as is explained previously about the Setup Links menu Select the name of the file of the program s version to load within the available ones This file has the extension tsk and should be located in the directory where the program was installed by default in C SIBEL W20s Click the START button and verify the evolution of the loading process in the screen Finally a transmission completed message will appear
66. e group will be selected It is also possible to add tests for this purpose press the 511 BLO MU2 1 06 5 SIBELMED W20s User s Manual 44 Control key and select one by one with the mouse Printing It prints a report in the printer Window It allows organizing the windows automatically Help It presents this help At the right side of the screen a scroll bar appears in order to display the tests which have not enough space to appear on the screen In this window of the graphic it is possible to represent the symptoms of each test as superimposed areas and the numeric values of the selected parameter as XY The warnings are represented with a color code indicating its severity These codes are the following White Nothing No symptom Green Low Yellow Medium Red High When clicking on View Parameters in the Setup menu the next screen appears Value to view FVC PEF 21 Show its variability Range of viewing values Parameter Maximum Minimum F C 3 0 2 0 FEVI 10 PEF 6 0 40 Variability 1 0 05 G2 Show in the report 6 Data v Graphi ez 511 BLO MU2 REV 1 06 aT A 5 SIBELMED W20s User s Manual 45 In this window it is possible to set up the maximum and minimum values for each parameter which appears in the trends report These parameters are the following FVC FEV1 PEF and the Varia
67. e information of the windows ORDER BY It orders the list of patients by the selected criteria register surname reference SHOW DELETED RECORDS It allows showing the records marked to delete HELP It accesses to the exploring window help Clicking with the mouse s right button on a patient it appears a menu with the next options DELETE It allows deleting the patient and the corresponding tests RECOVER It allows recovering the patient if it is marked to delete Double clicking on a patient permits acceding to the patient card 511 BLO MU2 REV 1 06 0 SIBELMED 205 User s Manual 52 2 8 3 DATA BASE MAINTENANCE The Maintenance option included here is oriented only to the data base and not to the device hardware The information for that must be consulted in the corresponding chapter of the spirometer User Manual The options included are Clicking on the Network button a Windows dialogue box appears allowing the user to be able to connect to a network shared folder to access another computer s data base NEW PASSWORD To modify the password of a data base the working password must be introduced before pressing ENTER Then the system asks for the new password and its confirmation It is very important to introduce an easy to remember password If the password gets forgotten please contact with the SIBEL S A Technical Service and they will explain the recovering process
68. ed E Remove all installed Features InstallShield Back Next E Repair It reinstalls the program If there is a damaged or lost file it will repair it Remove It uninstalls the software but the database of the program is not deleted It can be found at the path where the installation was done 2 5 ABOUT ON SCREEN HELP The onscreen helps included in the Spirometry Software SIBELMED W20s are structured according to the MICROSOFT Windows system They help the user to handle properly the different options of the program In general each screen includes a Help menu where an explanation of the different options available is given This help is indicated on each screen with an icon a text or both 511 BLO MU2 REV 1 06 Tit SEES SIBELMED 205 Users Manual 26 Inside some texts underlined words or sentences are included e g INDEX in green color which lead to other helps for further details in the explanation For this purpose the cursor is placed over the word and a hand will be shown By pressing the left key the corresponding help will appear 2 6 MAIN MENU This screen presents the main options available in the Spirometry Software SIBELMED W20s_ with the corresponding sub options SETUP Printer Selection Parameters and Others Spirometry Maximum Pressure Pulse Oximetry Units Header Report Graphics and Others Interoperability Links Check Device Utilit
69. ed Report Curve F V Curve V T Curve VC Curve MVV Large graphs in report Print 3 Best PRE curves Print 3 Best maneuvers Print 3 Best PRE parameters e Graphics on the Screen Curve F V Curve V T Curves F V and V T e Store graphics in the DATA BASE Store graphics Save 3 Best maneuvers e Motivation for pediatric tests Allows selection among different pictures Allows selection of the level of the motivation aim regarding First maneuver compared to a percentage of the Predicted Value Rest of maneuvers compared to a percentage of the patient s best one To be selected the Sound Warning if the aim is reached e Language Several languages are available 511 BLO MU2 REV 1 06 5 SIBELMED W20s User s Manual 2 7 4 INTEROPERABILITY CONFIGURATION This menu allows you to configure the export of spirometry FVC VC MVV and Dilation tests to XML and PDF format when you save the test in progress in the database Select the INTEROPERABILITY option within SETUP menu Interoperability PDF Path C SIBEL W20 FicherosPDF Examine XML Path CASIBEL W20 Ficheros lt ML Examine File name format DCodeVYYYMMDDHHMMSS_TestT ype C LastNamel LastName2 Namel Name2 Y Y YYMMDDHHMMSS TestType Autosave PDF file SibelHL7link C External Bridge Application Without Bridge Application Local C Automatic 52 C kanua External Bridge Application c SIBEL T e
70. een presents all the information related to each performed maneuver A is added to REF when the reference values have been extrapolated and in the report appears the text Warning Reference values extrapolated We can distinguish the following parts 511 BLO MU2 REV 1 06 a ae A S be 17eC7 SIBELMED W20s User s Manual 68 x L pez Garcia F Agely Male C Female F BTPS 1 086 PARAMETER ACT PRED PRED il 6 00 5 31 113 0 5 1 2 76 1 4 26 4 31 99 1 5 86 FEVO S FVC 45 96 90 FEV3 FVC 97 67 E 2 3 4 5 6 8 9 1 5 6 60 10 06 66 m r Selected Maneuver pese XX Best 6 00 Cough groe Best FEVl 4 26 iac 4 Wheezing o e e e rAlerts ATS ERS Repeatability ATS ERS CE oC E M rev Sputum o e e e ieee QR amp Be PARAMETERS It presents all the parameters selected in OPTION PARAMETERS AND OTHERS with the Observed values and the Reference value as well as the between the OBS value Observed and the REF Reference of the best or the best 3 maneuvers performed depending on the option selected on SETUP graphics other In the case of Postbronchodilation the following columns appear PRE Prebronchodilation Value or PRE1 PRE2 PRE3 in case of ha
71. een without losing the information available up to that moment Only if the patient is changed by entering a new code or performing other operations the data might be lost Anyway the device will always warn with a message on screen before deleting the information A2 6 PRINTING AND OR SAVING IN THE DATA BASE The system displays stores or prints the values for all the maneuvers On the contrary only the curve for one maneuver is printed or stored in the data base The system selects as default the curve for the best maneuver unlike in the spirometry it cannot be number 1 If the specialist considers that it is right other curve can be selected To select a different maneuver from the one selected by the system as default check Selection and deleting of maneuvers section After the desired maneuvers of expiratory and inspiratory pressure have been performed the following operations can be performed A PRINTING RESULTS A report will be performed which presents the same information of the window Summary of the test together with the patient data and the curves for the selected maneuvers 511 BLO MU2 REV 1 06 511 BLO MU2 REV 1 06 S e 1N7C7 SIBELMED 205 Users Manual 155 eee SIBEL S A Reference 1111111111 Date Name Lopez Garcia Francisco Sex Man Age 35 Temp C Pres mmHg 760 Motive Procedence Technician References P MORALES Ethnic F Version 511 BLA
72. em in order to set up said system access controls Access register Accesses to the different databases are stored on the one access register file Back up copies back up and recovery The user must at least once a week make back up copies of all data in order to guarantee full recovery of data in the case of a computer system failure In the case of the Spirometry Software full recovery of all database data is guaranteed if the entire BDSIBEL directory of the application directory is saved Said back up copy must be stored at all times in a different place to where the equipment on which the software is used is located Operating System Setup On a Windows operating system level 2000 XP Vista 7 and 8 and for NTFS partitions it is possible to restrict the access to the different databases using the security characteristics of said file system Generally speaking the control of access to databases is covered by the following points 511 BLO MU2 REV 1 06 a ea SIBELMED 205 Users Manual 172 Setup of Identification and authentication Each user that accesses the system must have a unique username and password whether a local user or a network user connecting to a domain The passwords must be changed periodically with a freely selected frequency and whilst a series of passwords remain valid they will be stored in an unintelligible way User definition can be carried out from the Users and
73. ental Data temperature pressure relative humidity Graphics in VOLUME TIME mode 3 2 6 MAXIMUM VOLUNTARY VENTILATION Parameters e MVV l min Maximum Voluntary Ventilation e Br min Br min Breathing Frequency of MVV 511 BLO MU2 REV 1 06 a ea SIBELMED 205 Users Manual 117 Normalized Predicted sets to be selected among different standards Ethnic Factor for Predicted values Patient Identification Data Environmental Data temperature pressure and relative humidity Graphics in VOLUME TIME mode 3 2 7 POSTBRONCHODILATION TEST Same parameters as in FVC Comparing methods between PRE and POST e 9o Average between PRE and POST between REF and POST between PRE and POST e Difference between PRE and POST Graphics Superposition PRE and POST in the external printer 3 2 8 BRONCHOCONSTRICTION TEST Parameters e FVC I Forced Vital Capacity e FEV1 1 Idem in 1 second e PEF 1 5 Peak Expiratory Flow e FEF25 75 1 5 Forced Mesoexpiratory Flow the FVC test parameters can be selected 511 BLO MU2 REV 1 06 SIBELMED W20s User s Manual 118 Patient Identification Data Environmental Data temperature pressure and relative humidity Continuous or shorter methods Deviation Percentage between Basal amp Dissolution Superimposition of graphics in FLOW VOLUME or VOLUME TIME mode Stopwatch to control the steps Type of dru
74. eplaced by the new ones including the exported tests 2 14 3 EXPORT TESTS TO e MAIL This module of the program permits exporting tests to a format delimited by quotation marks files with CSV extension through the email so they can be read by other systems The module can be acceded from the exploring window option Options Export to To perform the export 1 Mark the tests to be sent 2 Next the email assistant installed in the computer will pop up appearing a new message with the attached documents PRUEBAS and GRAFxxx which contain the selected tests 3 Introduce the address email and the desired information 4 Press Send to transmit de mail 2 14 4 IMPORT OF TESTS FROM A REMOTE CONSULT The export module in combination with the import module enables the exploration in the local consult of the tests performed in a remote consult Both consults must have the 511 BLO MU2 REV 1 06 SIBELMED 205 User s Manual 90 spirometry software SIBELMED W20s available For that after having made all the spirometric tests of maximal pressures and or pulse oximetry the following steps must be performed EXPORT gt TRANSPORT gt IMPORT A EXPORT Use the option Export to format CSV in the remote PC to store the tests to be explored in the local PC as indicated in the previous paragraphs The tests will be stored in the selected directory in the files PRUEBAS
75. er or authorized dealer in order to ensure the safety of the patient and the correct working order of the spirometer Failure to do so may result in an increase of emissions or in a decrease of the immunity of the equipment 511 BLO MU2 REV 1 06 72 S be 11ec SIBELMED W20s User s Manual 2 INSTRUCTIONS FOR USE AND INSTALLATION 511 BLO MU2 REV 1 06 Tt A SIBELMED W20s Users Manual 13 2 1 INTRODUCTION SIBELMED W20s is a software application for the transfer analysis storage and or register of spirometric signals which works under Microsoft Windows It is compatible with different DATOSPIR spirometers among them the DATOSPIR TOUCH and it can work in real time or deferred time depending on the spirometer characteristics It allows The management of different Data Bases The performance of FVC VC MVV Postbronchodilation and bronchoconstriction tests when connected to a compatible spirometer graphic presentation in F V and V T modes The selection of different Reference Parameters The selection of different types of diagnosis The printing of different reports The presentation of graphics for motivated tests for children The performance of SpO2 MEP MIP and Sniff pressure measurement tests when connected to a compatible spirometer supporting this functions 2 2 PREVIEW This product is manufactured under strict quality controls
76. erator or by the best FVC FEV1 default criteria Also are displayed the best FVC and best FEV1 as the highest values recorded among the performed and stored maneuvers e Start of expiration in VC and MVV by signal level e Selection of tests and parameters in VC and MVV Highest value in VC or MVV 3 3 3 USEFUL LIFE The useful life is 7 years 3 3 4 STORAGE It is recommended to store a 259C at this temperature manufacturers guarantee 1000 000h At 70 C the life is reduced to 2000 h See specifications of CD ROM for more information 511 BLO MU2 REV 1 06 D SIBELMED W20s User s Manual 124 3 3 5 STANDARDS SIBELMED W20s Spirometry Software has been designed according to the following harmonized standards EN ISO 23747 2009 EN ISO 26782 2009 AC 2009 EN 62304 2006 AC 2008 EN 62366 2008 EN 1041 2008 EN ISO 15223 1 2012 EN 980 2008 EN ISO 14971 2012 EN ISO 80601 2 61 2011 Only for software with SpO Module EN 60601 1 2006 2010 In addition the W20s_ software fulfils ATS ERS 2005 recommendations and the SEPAR recommendations 511 BLO MU2 REV 1 06 SIBELMED W20s Users Manual 125 3 4 SYMBOLS MANUFACTURER Manufacturer s name and address Manufacturing Date TEMPERATURE LIMITATION LIMITATION OF MOISTURE LIMITATION OF PRESSURE SEE PRECAUTION 511 BLO MU2 REV 1 06 SIBELMED W20s User
77. es mmHg 760 Reason Procedence Technician Predicted SEPAR SPAIN F BTPS 1 086 Version 511 BLA 1 05 FVC REPORT Maneuver No 1 PARAMETER ACT PRED PRED Best FVC 1 6 00 113 5 31 Best 1 4 26 99 4 31 BFevl BFvc 71 11 90 79 11 FVC 1 6 00 113 5 31 FEV0 5 1 2 76 FEV1 1 4 26 99 4 31 FEV3 1 5 86 FEV0 5 FVC 45 96 FEV1 FVC 71 11 90 79 11 FEV3 FVC 97 67 FEV1 VC 1 5 6 60 66 10 06 75 1 5 1 85 94 1 97 50 1 s 3 77 71 5 30 25 1 8 5 61 FEF25 75 1 s 3 41 80 4 24 FEF75 85 1 s 1 47 FET25 75 s 0 88 100 6 33 FEF50 FIF50 1 00 152 0 66 MTT s 0 82 FEV1 FEV0 5 1 55 107 1 45 FEV1 PEF 10 77 162 6 64 50 1 3 76 FIVC 1 6 00 FIV1 1 4 26 FIVl FIVC 71 09 FEV1 FIV1 1 00 125 0 80 PIF 1 5 6 50 PEF PIF 1 02 73 1 39 Vext 1 0 06 MVV Ind 1 min 127 92 FEV6 1 6 00 FEVl FEV6 71 11 COPD index Lung Age 25 11 E3727 7 22722228 SIBELMED W20s User s Manual 511 BLO MU2 Repeatability ATS ERS FVC No FEV1 No Interpretation Miller s Interpretation 09 05 2014 Time 11 17 Height cm 175 Wgt Kg 76 Humidity 65 Smok I BMI 24 8 Transducer Disk Ethnic F 100 Obstructive ventilatory alteration REV 1 06 sibel sibel sibel ID Code Name Sex Temp 9C Reason Procedence Technician Predicted F BTPS Version 11111111111111111111 L pez Garc a Francisco Male Age
78. g and accumulated dose Calculation of PD20 FEV1 by mathematic adjustment or linear interpolation Numeric and graphic dose response data summary on screen Link with bronchodilation test 3 2 9 MAXIMAL PRESSURES OPTION PARAMETERS Both in the expiratory and the inspiratory tests it is measured e Maximum Pressure of the 5 maneuvers e Mean of the best 3 e Standard Deviation of the best 3 511 BLO MU2 REV 1 06 a ea S e N7C7 SIBELMED 205 Users Manual 119 RANGES AND MEASUREMENTS Measurement Range 295 hPa 300 cmH O e Resolution 1 hPa 1 e Precision 3 Sampling Frequency 100 Hz e Maneuvers under 9 8 hPa 10 are dismissed Start of Maneuver When the threshold of 2 95 hPa 3 cmH20 is exceeded e End of Maneuver Variation less than 1 hPa 1 cmH20O in the last 2 sec CONTROL e Number of maneuvers A maximum of 5 maneuvers of each type can be performed MEP and MIP e Maneuver Duration The maximum duration is 8 seconds e Maneuver Start When it gets beyond the 2 95 hPa 3 cmH20 threshold e Maneuver Ending Less than a 1 hPa 1 cmH20 variation in the last 2 seconds e Delay in the maximum pressure value calculation 1 second by default Can be configured in the Setup e Data Base The spirometer shares the data base for all the different tests 511 BLO MU2 REV 1 06 Ey 2727 22 279 4208 SIBELMED 205 Users Manual 120 ee eee ee 3 2 10 PU
79. has Finished installing PDFCreator on your computer The application may be launched by selecting the installed icons Click Finish to exit Setup by dfforge org 511 BLO MU2 REV 1 06 a ea Ey 2727 22 279 SIBELMED W20s Users Manual 21 7 If there is any database with a previous format in the folder c sibel W20s bdsibel it will be updated automatically leaving a copy of the old one into c sibel W20s bdsibelold 8 Once the installation is done it will create the SIBEL group of programs or the one chosen by the user and a shortcut will be created on the desktop 2 4 2 OPTIONAL MODULES ACTIVATION In case you have acquired one or more optional modules of the W20s software Bronchoconstriction SpO or MIP MEP you will have to enter the correct 15 digit key supplied in order to activate them Main Menu SETUP gt Utilities gt Options Activation In case you have acquired the options but do not have the key available please consult our after sales department 2 4 3 BLUETOOTH MODULE INSTALLATION A Bluetooth module needs to be installed on the PC for Bluetooth compatible spirometers The Bluetooth interface allows data to transfer to the computer both for performing real time testing and for transferring tests saved in the internal spirometer database The Bluetooth chip installed in the spirometer uses the Bluetooth Series Port service or profile known as SPP This will be the profile that
80. he START key and wait until the key icon changes into green color then perform the maneuver 511 BLO MU2 REV 1 06 DEM a SIBELMED 205 Users Manual 148 A2 5 TEST INFORMATION A2 5 1 WINDOWS DESCRIPTION SELECTING AND DELETING MANEUVERS For studying the evolution of the Maximal Pressure test the program has four windows Next these windows are displayed and how to interpret its information is commented A Window of maneuver in progress It represents the variation of pressure as the maneuver is taking place This window emerges by pressing the START key and disappears by finishing the maneuver when the Start key is pressed by waiting for 8 seconds or when a pressure lower than 0 98 hPa 1 cmH 0 during 2 seconds exists The horizontal line of dots indicates the reference value Once the maneuver is finished the position for the maximal 511 BLO MU2 REV 1 06 S be 1N7ed SIBELMED W20s User s Manual 149 pressure and its value are calculated The next message shows if this value is higher than the maximal pressure of the previous Bent manoeuvre parion another one maneuvers B Window of the best three maneuvers In this window the best 3 maneuvers are ordered according to the maximal calculated value of pressure In the example of the upper graphic for M3 Memory 3 the higher maximal value the expiratory pressure would be calculated M4 would
81. he icon in the main menu Without Bridge Application This option allows you to use the W20s without the work list of scheduled patients However it continues generating the PDF file and the XML file 511 BLO MU2 REV 1 06 0 SIBELMED 205 User s Manual 36 2 7 5 SOFTWARE LINKS Select the LINKS option inside the SETUP menu Device Setup E x Transducer SPIROMETER DISK Equipment p1zo D110 Channel seriar Channel Serial Port comi Speed 19200 C S680 590 0 This screen allows selecting the next information e The Transducer to be used SPIROMETER it shows which transducer it is being used among the available ones if so Fleisch Turbine or Disposable The disposable transducer uses a calibration factor This allows exchanging the transducer easily without any need for a calibration This factor is printed in an adhered label The DATOSPIR 120 DATOSPIR 600 and DATOSPIR TOUCH spirometers can be used with different transducers DISK it shows that the signal corresponds to the ATS standard curves available at the disk These ones can be used in the learning process of the program without having to 511 BLO MU2 REV 1 06 ey eat A SIBELMED W20s User s Manual 37 blow air in the transducer or for the software operation verification e The Device being used It allows selecting the spirometer model that is
82. he personalization of the device PRUEBAS CSV It contains the tests of the data base GRAFICAS CSV It contains the graphics in Flow Time format 511 BLO MU2 REV 1 06 DU ERU L3727 7 22722228 SIBELMED W20s User s Manual 104 The files of the previous transfer get renamed with the extension OLD 5 If you want to visualize the information of any of the files load them with MICROSOFT s program EXCEL 6 Load the files in your usual e mail program and send them to SIBEL S A Technical Department or to your local Dealer If you don t have e mail you can print de data and send them through FAX 511 BLO MU2 REV 1 06 72 5 77 7 SIBELMED 205 User s Manual TECHNICAL SPECIFICATIONS 511 BLO MU2 REV 1 06 Tika SIBELMED 205 Users Manual 106 3 1 3 1 3 1 SOFTWARE SPECIFICATIONS 1 COMPUTER INSTALLATION AND REQUIREMENTS The computer installation will be carried out according to the User Manual The computer must meet the following minimum requirements Minimum Recommended RAM Memory 1 GByte 2 GByte or more Hard Disk 20 MByte 1 GByte or more Graphic Card 800 600 1024 768 or more Monitor 15 17 Ports RS232 USB RS232 USB Ethernet Backup Unit Recommended It is recommended to select in the operating system big letter fonts for a better visualization of the program This option is found in the Screen Properties Please
83. ies Activation Code Software purchase Update Bios Update Flash Download data of the device About Exit 511 BLO MU2 REV 1 06 Ty Sey S be 177CC SIBELMED W20s User s Manual 27 DATA BASES Patient Explore Data Base Maintenance Select Data Base New Password Reindex Show deleted records Pack Export tests CSV format Import tests CSV format OPTIONS Spirometry Icon with patient performing the tests Maximum Pressure MIP MEP Icon Pulse Oximetry SpO Icon HELP About Helps About the Software About Main Menu Visit SIBEL web page By entering each of these options the corresponding information is available Next a description of each function available with the SIBELMED W20s is made 2 7 SOFTWARE CONFIGURATION The Spirometry Software SIBELMED 205 is versatile program with multiple possibilities of functioning Some of them could be of no use for certain users So once the Installation and Configuration process has finished it is necessary to adapt it to the needs of each user Thus the 511 BLO MU2 REV 1 06 Tit aay SIBELMED W20s Users Manual 28 system will be configured in each case and its handling and understanding of the functioning will be easier Next the different options that can be configured are detailed 2 7 1 PRINTER SELECTION Select the option PRINTER SELECTION into the SETUP The selection is made by placing the mouse cursor over the label SETUP an
84. iluent has not been made the graphic dose response shows the value for PD20 The graphic dose response is shown mathematically adjusted by means of a logarithmic function C1 C2 log x if the coefficient of determination is better of 80 In this case the calculation of PD20 is made solving it in the adjustment equation If the coefficient of determination is lower than 80 the graphic is presented linearly and the calculation of PD20 is made by linear interpolation 511 BLO MU2 REV 1 06 SIBELMED W20s Users Manual 167 5th Step CONSTRICTION DILATATION BD When finishing this test if you need to give the patient a bronchodilator medicine to revert the resultant bronchoconstriction press key Dilat in the data screen of the previous display Bronchodilator substance administrations Partial Accum Dose mg ml 5 00 fi 00 BD Substance Salbutamol e Enter the data for the bronchodilator medicine press The chronometer will be enabled and will return to the tests screen e e Apply the bronchodilator to the patient e After the normalized time perform a series of maneuvers e Store the best maneuver and repeat the previous process if necessary A3 1 4 SUMMARY PRINTING and or SAVING OF THE TEST The summary of the bronchoconstriction is presented in graphic form graphic dose response previously shown or in nume
85. ing Window of the best 3 maneuvers e Summary window of the test data e Window of maneuver in process e Window of memory display A2 3 MAXIMAL PRESSURES CONFIGURATION It is recommended for the user to set up the Maximal Pressure module according to their needs The Maximal Pressure configuration menu is accessible from the main screen in Setup Parameters and Others Maximal Pressures or from the maximal pressure tests screen in Setup Maximal Pressure TISPIROMETRY SOFTWARE SIE Setup Data Bases Options Help Setup Options Maneouvres Printer Selection aM Parameters and Others gt Spirometry Graphics and Others Links PulseOximetry Utilities gt Report Header Printer Selection M ximum Pressure 511 BLO MU2 REV 1 06 a ae S be 1N7e SIBELMED W20s User s Manual 143 The following window will appear in the dialogue box Maximum Pressure Initial Time 10 s References Adult P MORALES Child SH WILSON x Colors 1 2 M3 4 5 Kg GO Q OK Exits from the dialogue box updating the changes Cancel Exits from box without updating the changes Help It shows the help Not all the references have values for adults and children so the program will not enable to select the non existent references The measurement delay has as default a value of 1 0 s although the user can set
86. ir corresponding tests and it also has the next menu options e Setup Data Base e Options e Window e Help Some quick access icons are available for the options Test Data Trends Window Export Tests Import Tests Help and Exit SETUP PRINTER SELECTION Check SETUP PRINTER SELECTION PARAMETERS AND OTHERS Check SETUP SELECTION OF 511 BLO MU2 REV 1 06 aa 5 SIBELMED W20s User s Manual 47 PARAMETERS GRAPHICS AND OTHERS Check SETUP GRAPHICS SELECTION DATA BASES SELECT DATA BASE Check DATA BASES DATA BASE MAINTENANCE NEW PASSWORD Check DATA BASES DATA BASE MAINTENANCE DELETE ALL RECORDS This option is used to delete all the data stored in the selected data base and they cannot be recovered The content of the base is deleted but not the directory where it was stored DELETE RECORDS It allows deleting only the selected records If the option Show deleted records is active DATA BASES DATA BASE MAINTENANCE in the main menu those records will appear shaded otherwise they disappear from the exploring window RECOVER RECORDS It allows recovering the selected deleted records If the option Show deleted records is active DATA BASES DATA BASE MAINTENANCE in the main menu the deletion mark disappears and those records appear non shaded otherwise the Recovered records appear again in the exploring window REINDEX Check DATA BASES DATA BASE MAINTENANCE
87. is program has been acquired you should introduce the key from the CD label following the instructions of the user manual 2 If the program is running on DEMO mode the time showed is what is left to use it 3f you wish to acquire it push the Register button and send the data to your dealer or to SIBEL 5 4 so the activation code of the program can be provided After the period has ended some options of the program will be disabled o This allows registration at the moment If the specified period is over the program will no longer be able to be used without activating it showing the next warning message ATTENTION The evaluation version period has ended For the activation of the program select the option Utilities Activation Code from the Setup menu The next box will appear 511 BLO MU2 REV 1 06 SIBELMED 205 Users Manual 101 VALIDATE ACTIVATION CODE 4 x Code 1 9 0 0 Enter the activation code that has been provided when acquiring this software From now on the Sibelmed W20s will be unblocked to be used freely without any problems 2 17 SOFTWARE PURCHASE This option opens the SOFTWARE VALIDATION screen previous page from which it is possible to e Access to the Registry It allows filling the needed data to obtain the activation code and send it through e mail to SIBEL S A or your local dealer
88. ll the lungs completely and then start the FORCED ESPIRATION followed by the FORCED INSPIRATION if needed 3 Indicate the patient the most convenient way of taking the transducer without obstructing the air passing through when making the spirometric maneuver and put him the nasal tweezers 4 Press the START icon and from that moment the patient has 30 seconds to start the forced maneuver Just before pressing the START icon and only when the transducer connected to the equipment is a disposable one the Data icon gets converted into an icon that allows changing the disposable transducer code Pressing this button the transducer code will be able to be introduced x Dis Fct 0099 9 9 This code will be applied by the equipment and will always 511 BLO MU2 REV 1 06 Li EGRE Ey 2727 22 7 279 SIBELMED W20s Users Manual 67 appear in the title line of the results summary window It is also possible to modify this code through the Transducer Code option in the Setup menu If the lot is not yet added to the program the next subwindow will appear to enter the K values Enter K factors E x E E 9 5 After the first spirometric maneuver the patient can perform the maneuvers indicated by the technician 2 9 3 MANEUVER DATA After having performed at least one spirometric maneuver we can enter the Maneuver Data window through OPTIONS MANEUVER DATA DATA Icon This scr
89. more errors and or lowest addition the worst maneuver ATS ERS ALERTS For each maneuver the ATS ERS criteria that are not fulfilled are indicated ET End of Test based on the EOTV and FET criteria the user can change the status of the FET criterion if he she 511 BLO MU2 REV 1 06 SaaS 5 SIBELMED W20s User s Manual considers that the patient has tried to exhale for a longer period than the criterion EX Start of test based on back extrapolation For a complete description of these alerts consult section QUALITY OF FVC TEST in the TECHNICAL SPECIFICATIONS chapter NLHEP ALERTS For each maneuver the NLHEP criteria that are not fulfilled are indicated ET End of Test based on the EOTV and FET criteria the user can change the status of the FET criterion if he she considers that the patient has tried to exhale for a longer period than the criterion PEFT Time to reach the PEF EX Start of test based on back extrapolation For a complete description of these alerts consult section QUALITY OF FVC TEST in the TECHNICAL SPECIFICATIONS chapter REPEATABILITY ATS ERS If three or more acceptable maneuvers without EX or ET alerts have been performed the repeatability criteria for FVC or FEV1 parameters is indicated if the two largest values of FVC or FEV1 from maneuvers with an acceptable start without EX alert are within 150 ml of each other respectively if FVC 1 0L the crite
90. n to the Calibration Volume 1 the system takes the calibration factors F ESP and F INS 1 00 which corresponds to the original manufacturer s calibration It is convenient to use this calibration only as orientative and only if a syringe is not available 511 BLO MU2 REV 1 06 ey ear A SIBELMED W20s User s Manual 99 CALIBRATION RECORD The spirometer has a record with the expiratory and inspiratory factors of the last thirty performed calibrations This is useful for those centers which require a quality control in the processes they use Click on the key Base in the initial screen of the calibration process 0__12 09 2010__13 20 Goes back to the initial calibration screen Help Shows the help Report Prints the current records Delete Deletes the selected record The information displayed in the report is Number of record Date of calibration Time of calibration Device calibrated Temperature Pressure Humidity Expiratory factor Inspiratory factor Calibration volume Technician who performed the calibration 511 BLO MU2 REV 1 06 DU San S Ey 2727 22 279 SIBELMED 205 Users Manual 100 2 16 ACTIVATION CODE This option is used to activate the program once the evaluation period has ended During this 30 day period the program warns about the remaining ALIDATION OF THE SOFTWARE MWARNINGIH ij You have 29 days to use it 1 If th
91. n patients you should be familiar with its operation All information necessary for its operation is available in this Manual For additional training on the technique or on the product contact SIBEL S A or your dealer 1 5 EFFECTS ON PATIENTS USING THE SPIROMETRY SOFTWARE The spirometry tests require patient cooperation Complete forced expiration is required to obtain meaningful patient FVC values The clinician administering the test must assess the patient s capacity to perform the spirometry test Special attention must be paid to children the elderly and the disabled 511 BLO MU2 REV 1 06 a ea SIBELMED W20s Users Manual 11 An analysis of the results of spirometry tests is not enough to give a correct diagnosis of the patient s clinical condition The patient s records and any tests that the clinician believes necessary must therefore also be considered A doctor must interpret all data to determine the course of treatment required The patient s symptoms and capacity to perform a spirometry test must be taken into account by medical staff before any spirometric testing is undertaken Acceptability of a test is the responsibility of the medical professionals The spirometry software should not be used when it is likely that the validity of the results could be compromised by external factors All accessories and spare parts must be originals and they must be requested from the manufactur
92. ne test to another Among them we point out e Dateand time of test performance e Smoker Ind Smoker Index Between 0 and 200 It is equal to the number of cigarettes smoked in one day divided by 20 and multiplied by the number of years asa smoker Cigarettes day x years as a smoker 20 e Cigar d Cigarettes per day to calculate the Lung s Age e Age in years it is taken automatically from the date of birth of the Patient Card e Height in Inch cm between 39 y 86 Inch 100 and 215 cm 511 BLO MU2 REV 1 06 ea A 5 SIBELMED W20s Users Manual Patient data affect the calculated value references and diagnostic make sure that the data is correct e Weight in Pound Kg between 33 and 297 Pound 15 and 135 Kg e Temperature in the room in C9 e Pressure in hPa mmHg e Humidity in the environment in 9o These 3 last values are taken automatically if the equipment has a meteorological station integrated AN Environmental conditions affect the BTPS factor and the calculation of the volume make sure you are correct There are other fields like e Motive or cause for performing this test e Precedence or centre department doctor etc where the patient comes from e Technician who makes the test e Ethnic Factor and Theoretic Values used in the test e Comments on the test When pressing OK the next screen appears 511 BLO MU2 REV 1 06 5 A
93. ntration 511 BLO MU2 REV 1 06 a ea SIBELMED 205 Users Manual 159 The procedure in both cases is the same The variation lies in the way of applying the medicine In the first case the patient breaths the concentration for a while and in the second case we apply the inhalations to make it quicker The steps of the test are 1st BASAL BAS Perform a basal spirometry 2nd DILUENT DIL Apply a diluent to the patient if convenient and perform a spirometry that compares to the basal 3rd CONSTRIC BC1 Apply the patient the first dose of bronchoconstrictor drug After the stipulated time perform the spirometry It is compared to the DILUENT DIS or to the BASAL BAS if the diluent has not been made Go to the next step to continue with the test 4th CONSTRIC BC2 Repeat the last step but with the second dose of drug 5th CONSTRIC BC3 Repeat the last step but with the third dose of medicine The process can be repeated until it is convenient The system allows applying a maximum of 10 doses CONSTRIC BC10 6th When the lung function parameters show a significant response after a new confirmation or according to the criteria of the operator who makes the test the bronchoconstriction test can be finished The system analyses and shows the value of PD20 graphical and numerically 7th CONST DILAT Finally once the test is finished the bronchodilator medicine has to be applied t
94. o activate PRESENT DELETED RECORDS e CONSULT Search a patient card e TRENDS It shows a report of all the selected test of the patient In this report it is possible to see the evolution of the next parameters FVC FEV1 PEF and the variability of each one of them e EXPORT It gets to the exporting module to be able to select tests of this patient configure the export destination and export the tests with the format implied by the quotation marks The fields corresponding to the card are Field Type Nr Characters Reference A N 10 Date of Birth N 8 dd mm yyyy 511 BLO MU2 REV 1 06 Pa a 5 SIBELMED W20s User s Manual 42 Name A N 20 Surname A N 38 Profession A N 20 Sex Address A N 50 City A N 30 Postal Code A N 5 Country A N 11 Telephone 1 A N 10 Telephone 2 A N 10 Comments 5 lines A N 74x5 A N Alphanumeric Field Numeric Field Date format dd 01 02 09 10 mm 01 02 09 10 11 12 yyyy 1998 B Display in Tests the different tests of a patient with the most important parameters In order to display all the Test Data there are two ways one is to choose the test selecting it in the list of tests of the patient card and press twice with the mouse left key The other way consists of choosing the test and pressing the key Tests in the Patient card C Search a patient already existent in the data base For this purpose order the base through the INDEX by e Reference
95. o improve the two largest PEF values matching within 11 5 maneuver Don t Hesitate EX error see ATS ERS alerts must start exhaling Blast Out PEFT error time to reach PEF The patient must exhale as Faster higher than 120 ms hard firm and fast as possible The patient has abruptly Blow Out ET error FET lt 6 seg and EOTV interrupted exhalation The Longer gt 100 ml during the last 0 5 s patient must exhale even more of the maneuver and expel as much air as possible from his her lungs If there are not 2 acceptable The maneuver differs Blast Out maneuvers with the significantly from the previous Harder ones The patient can exhale even more vigorously and achieve a higher peak flow Deeper Breath If there are not 2 acceptable maneuvers with the two largest FEV6 values matching within 150 mL The maneuver differs significantly from the previous ones The patient must inhale more deeply and exhale even more air Good Test Session After 2 acceptable maneuvers that match TEST COMPLETE Adequate number of good maneuvers Refering to the acceptability of the last maneuver performed Refering to the repeatability of the maneuvers III NLHEP QUALITY GRADING QC GRADES At the end of the test maneuvers session a quality grading from A to F will be displayed to indicate the reliability of the results according to NLHEP criteria 511 BLO MU2 REV 1 06
96. o return the resultant bronchoconstriction Up to two steps can be made in this mode 511 BLO MU2 REV 1 06 SIBELMED 205 Users Manual 160 A3 1 2 INPUT OF TEST DATA The procedure for the input of the patient and environmental parameters is the same as the one described in the ENTERING PATIENT AND ENVIRONMENTAL PARAMETERS section Once the previous data are filled in press the CONST icon or direct to option menu in Options gt Bronchoconstriction The following setup window will appear Normal Mode Iv Short Mode m Use Diluent Iv Time between Constrictions miri Time between Dilations fi 5 Initial Dose mg ml 5 BC Substance etacolina BD Substance Salbutamol Kd d e Select the method or functioning mode Normal mode Abbreviated short mode e Select if diluent is going to be used e Define the time between the application of the 511 BLO MU2 REV 1 06 a NERA S be 1N7eC7 SIBELMED W20s User s Manual bronchoconstrictor medicine and the start of the maneuvers Define the time between the application of bronchodilator medicine and the start of the maneuvers e Enter the initial dose of the bronchoconstrictor medicine mg ml e Write down the bronchoconstrictor medicine e Write down the bronchodilator medicine Once the previous data are filled in press OK button In addition to F V and V t g
97. og file are audited the security events viewer will have many more entries and will complicate the monitoring of unauthorized accesses The next stop is to activate the audit of access to objects the local security setup To do so access the Administrative Tools icon from the Control Panel Once there you must select the Local Security Directive and the Local 511 BLO MU2 1 06 ee TN 5 SIBELMED W20s Users Manual Directives branch from the directives You must then access Audit Access to Objects Both correct and erroneous accesses can be enabled Finally other files must be audited for example password files lt W20S_HOME gt Bdsibel lt lt gt NAME_DB gt PW TXT if access to the NAME_DB database by other users has not been completely limited Access register description Access to the different databases are stored on the one log file ESPWIN log in the BDSIBEL folder of the directory where the application is installed by default C SIBEL W20S and from now on lt W20S_HOME gt Bdsibel This file is created the first time that the application is executed and cannot be deactivated The system administrator is responsible for the maintenance of said file with regard to size and the preparation of a monthly report where the periodic reviews carried out are analyzed and any problems detected reported should there be any The log file is saved by line e User Time and date of a
98. order to measure the parameters ERV and TV correctly each maneuver must have at least four respiratory cycles 511 BLO MU2 REV 1 06 SIBELMED W20s Users Manual 75 5 The graphic is displayed in Volume Time mode and the motivation graphic is not available 7ESPIROMETRY SOFTWARE SIBELMED W20s Data Base sibel J Reduces the graphic curves 6 The report with the parameters and graphics is displayed next 511 BLO MU2 REV 1 06 Wi eT S be iNeC SIBELMED W20s User s Manual 76 LUNG FUNCTION REPORT Reference 1111111111 Date 20 09 2010 Time 11 07 Name Lopez Garcia Francisco Sex Man Age y 35 Height cm 180 Wgt Kg 75 Temp C 25 Pres mmHg 760 Humidity 65 Smok I Motive BMI 23 1 Procedence Technician Transducer Demo References SEPAR Ethnic F 100 Version 511 BLA1 0 VC REPORT Maneuver Nol SIBELMED W20s PARAMETER OBS REF 1 3 36 TV 1 1 11 ERV 1 0 73 IRV 1 1 53 1 2 64 s 1 70 Te s 2 68 Tt s 4 38 Ti Tt 38 80 2 11 MAXIMUM VOLUNTARY VENTILATION TEST PROCEDURE The procedure to make the test of Maximum Voluntary Ventilation MVV is similar to the one described in the FORCED VITAL CAPACITY FVC TEST PROCEDURE section but with the following variations 1 If the test is performed to the same patient activate the icon and start the series of spirometric maneuvers If he is a new patien
99. ore stable and will have a slower response For a specific measurement it is recommended a high value of average On the contrary for a desaturations study a low value will be better A1 4 PULSE OXIMETRY TEST PROCEDURE As it has been said before it is possible to make single measures and long term studies 8 hours approximately In long duration studies it is advisable to fix the probe to the patient finger with sticking plaster as at it is shown in the figure The sticking plaster must not stress the finger to avoid modifying the perfusion 511 BLO MU2 REV 1 06 SIBELMED W20s Users Manual 133 1 5 PERFORMANCE OF PULSE TESTS To enter the pulse oximetry press over the pulse oximetry icon from the main menu 1 5 1 INPUT OF PATIENT AND TEST DATA If the patient and test data have been previously entered the program will directly go to the pulse oximetry test screen considering the previous data If no patient is activated the program will show a dialogue box to enter the data After pressing OK in the Patient Card the program will display a new dialogue box as the one shown next to enter the test data x Day Month Year Time Reference Age y 35 Date os 2010 45 Francisco Smok Surname Lopez Garcia Cigarr ds Height cem 0 weignetkg 75 23 1 Normal weight Temp 0 lf
100. ort Data Base D SIBEL W20s Bdsibel sibel NO REFERENCES No Reference Typo PL 2 Date Time 1111111111 FVC 1111111111 FVC 1111111111 FVC 0004 1111111111 VC 22702 7027 0005 1111111111 3 35 1 11 20 09 2010 10 42 00 xl 9 Bon 2 14 5 DISPLAY RESULTS THROUGH OTHER SYSTEMS The information of the generated files are fields between inverted comas separated by a semicolon 17 02 1999 08 21 24 56 165 0 Woman 1 SEPAR The file structure is a table with the same number of columns for each line Each line represents a record There are tests 511 BLO MU2 REV 1 06 D SIBELMED W20s User s Manual 92 like the FVC VC and MVV which fill only a record The dilation tests fill two records as well as the maximal pressure tests The constriction tests take up a variable number of records In the same column there always exists the information of the same field or data The first record is reserved for the name of the fields There are two fields in the PRUEBAS CSV file Graphic File and Graphic Column which enable to associate the dots of the graphic pressure time to the test For example if File Graphic 1 and Graphic Column 23 the dots for the graphic for this record are located in the GRAFOO1 CSV column 23 2 14 6 EXPORT FROM THE DATA BASE The program offers the option of ex
101. ows to Maneuver Start START Icon When activating this option the device is ready to start the spirometric maneuver Maneuvers Data DATA Icon Allows to e Display the available information of the performed maneuvers e Store a maneuver in the Data Base for a Bronchodilation e Delete a maneuver e Get a maneuver printed report e Present the diagnosis Test Data Without icon accessible by options Allows displaying some patient data environmental or other data related to the test being performed Graphics SEL Icon It allows presenting on screen any of the graphics corresponding to the performed maneuvers as well as superimposing some of them The asterisks indicate the position taken by the last maneuver Report Printer Icon It allows making a report corresponding to the selected maneuver in the screen of Maneuver Data Auto Scale Icon with framed graphic When activating this option the graphics axes adjust their dimensions without losing the relation 2 1 5 they are equal to 511 BLO MU2 REV 1 06 5 SIBELMED W20s User s Manual 64 1 in the graphic F V and 1 1 is equal to 2 s in the graphic V T and only in FVC mode Zoom and Icons lens and lens Enlarges or reduces the graphic maintaining the relations previously indicated Organize Windows Without icon accessible by options This option allows the user to organize the different selected windows proportionatel
102. porting from the patient s card This option enters the export module without opening the window Patients In the window Patients Tests it is possible to select and export the patients tests which reference appears in the card of the previous picture Then proceed as explained in the previous sections 511 BLO MU2 REV 1 06 SIBELMED W20s User s Manual 93 INN RR x Beterence T 7 Day Monet Teac fzo reancisee ME funn hopes Coma C wmm flarceiens Fortal Codes o00 Country Telephone Wobile 4360059 Comments 3 Tests Parin Valer bet W 002 22 02 2005 10 20 UC 004 23 03 2005 10 19 004 01 12 2009 LLIOS 29002 Also from the Patient test card the option Export can be entered i ip In this case the program does not enter the export module but it exports directly the test displayed in this card This test is found by default in the subdirectory NTMP of the directory where the program was installed and it is stored as PRUEBAS CSV The previously exported tests will be deleted Test Data A Options Delete Mont Day Year Restore 11111111111111111111 Agety 1 34 41 Date os zors Test Data Graphic Alerts ATS ERS CET EX
103. raphs window also presents D R graph Dose Response A3 1 3 PROCESS OF THE TEST As commented above the Bronchoconstriction test is based on performing forced spirometries after the application of different doses of medicines and controlling the drop of FEV1 511 BLO MU2 REV 1 06 SIBELMED W20s User s Manual 212232455478 2 4 6 8 1012141618202224 The steps for the test are the following ist Step BASAL BAS 162 Start the process of forced maneuvers as described ENTERING FORCED VITAL CAPACITY TESTS section srmo rey sortwane w20s Data nase NWI Dose mg ml gas 0 04 0 4 40 40 0 2 4 6 8 1012141616202224 Prints a report on printer Once the adequate maneuvers are performed press the DATA icon 511 BLO MU2 REV 1 06 a ea SIBELMED 205 Users Manual 163 Maneuver Data BASAL x Nane L pez Garc a F Male Female PARAMETER ACT PRED PRED F BTPS 1 086 FVC ql 6 00 5 31 113 0 5 1 2 76 FEV ay 4 FEV3 1 5 86 FEVO 5 FVC 45 96 g9 1r 0 FEV3 FVC i ITET FEVL VC 8 l s 6 60 10 06 66 AD oO O0 QQ KRONE Em Selected Maneuver Best FVC 6 00 Cough ecc Best FEVl 426 rac q y Wheezing cc Alerts ATS ERS Repeatability ATS ERS ecc C EX
104. rective particularly EN55022 EN61000 3 2 EN61000 3 3 and EN55024 standards e The repairs checks or modifications inside or outside the warranty period are made by technical staff at SIBEL S A e The use of the software and the recommendations of use are made by qualified staff according to the User s Manual It is recommended to store the CD ROM at 25 C see Technical specifications A According to the different standards it is advisable to verify and or calibrate the medical products periodically in order to warrant the liability of its functions and the security of the patient user and environment It is advisable to make a general check of its safety systems adjustments functions etc with annual periodicity Do not surpass eighteen months without doing it in any case Make a check at any moment when a wrong functioning of the product is suspected These revisions must be done according to the Verifying and Adjustment Procedures of the manufacturer SIBEL S A by the manufacturer himself or the qualified staff authorised by SIBEL S A software W20s runs PC make sure you save the test before turning off the PC or disconnect the communications cable 511 BLO MU2 REV 1 06 eT EUREN 5 SIBELMED W20s User s Manual A Verify that the hardware of your PC works properly A Verify your operating system is properly installed and updated A Check if software updates are availa
105. ric form summary of data displayed next Enter the summary by pressing the Summary key of the data screen as well as the performance moment the applied doses 511 BLO MU2 REV 1 06 SIBELMED 205 Users Manual 168 e The Report key sends the test data and graphics to the printer e The Store key stores the test in the data base The graphics are saved if it is indicated in the set up options e Take into account that the next observed values compared to Basal to the selected Reference of the patient Solution if performed to the Basal Constriction to the Solution step if performed Otherwise to the Basal Dilatation to the Basal 511 BLO MU2 REV 1 06 GUI GENES zs E3 72727 2272228 SIBELMED W20s User s Manual ss ANNEX 4 COMPLIANCE WITH THE DATA PROTECTION ACT DIRECTIVE 95 46 EC Tt SIBELMED 205 Users Manual 170 A4 1 COMPLIANCE WITH THE DATA PROTECTION ACT DIRECTIVE 95 46 EC This section aims to facilitate the compliance of current legislation referring to data protection by the user with the use of this software Consult your local translation of the 95 46 EC directive brief description of the fundamental points of said legislation is given and what needs be done with the SIBELMED W20s Spirometry Software and or operating system in order to comply with the requirements of said
106. rion is 100 ml If there are no maneuvers without and acceptable start the ATS ERS repeatability criteria are not fulfilled Besides the previously said the following can be made from this screen STORE It stores the tests in the Data Base or in an intermediate memory Prebronchodilation mode to perform a later 511 BLO MU2 REV 1 06 ey SIBELMED W20s User s Manual 71 Postbronchodilation test An maneuver selected in the screen is stored Remember that the best maneuver is number one and that is why we recommend selecting it previously REPORT It allows getting a report of the maneuver selected DIAGNOSIS It presents the diagnosis of the selected maneuver The type of diagnosis can be selected in SETUP PARAMETERS AND OTHERS SELECTION DELETE It allows deleting the selected maneuver 2 9 4 PRINTING THE REPORT It is possible to make a report of any maneuver performed This option is found in the Maneuver Data window in the MANEUVER DATA section It is also possible to print a general report and a group with the different spirometric tests made to a patient in a certain session This option is accessible through the Printer Icon The reports of parameters and graphics in both modes are displayed next 511 BLO MU2 REV 1 06 eee sibel sibel sibel ID Code 11111111111111111111 Date Name L pez Garcia Francisco Sex Male Age y 34 Temp 9C 25 Pr
107. rwise the following report will be printed 511 BLO MU2 REV 1 06 DU ERU Ey 2727 22 7 279 SIBELMED 205 Users Manual 138 SIBEL S A Reference 1111111111 Date 20 09 2010 Time 10 59 Name Lopez Garcia Francisco Sex 35 Height cm 180 Wgt Kg 75 9 Pres mmHg 760 Humidity Smok I Motive BMI 23 1 Procedence Technician Transducer Demo References SEPAR Ethnic F Version 511 BLA1 0 PULSE OXIMETRY REPORT SIBELMED W20s PARAMETER OBS CT90 CT80 CT70 IDH 4 IDH 3 IDH 2 SpO2 Max SpO2 Avg 5 02 Min 5 2 Std PR Max PR Avg PR Min PR Std O amp YOOO oOotNooooooo T Study 1 00 32 B SAVING IN THE INTERNAL DATA BASE At any moment you can enter the option Store Test from the pulse oximetry tests screen TI sPiROMETRY SOFTWARE SIBELMED W20s 5 SOFTWARE SIBELMED W20s Data Base Setup Options Help Setup Options Help aj oo a OS Reset data m Test Data Change Patient Report Organise windows If the parameters have not been calculated because the thimble probe has not been applied during the study or because no study has been performed the following message will be displayed 511 BLO MU2 REV 1 06 SIBELMED 205 Users Manual 139 ATTENTION xf No Manoeuvres If the calculated parameters for the study have been stored correctly this message will be
108. ry and inspiratory factor and date are not modifiable it presents the ones available in the device Click on the Calibrate key Calibration Heisch xj ESP F INSP EF LT If there is disposable connected the next window will appear 511 BLO MU2 REV 1 06 a ea S e 1N7C7 SIBELMED 205 Users Manual 98 Calibration Disposable Dis Fct 4657 I INSP 0 Q ss 4 Make sure that the pneumotachometer is at room temperature If not wait for some minutes or cool it with air 5 Press the Calibrate key and start the calibration process emptying the syringe during two or more consecutive cycles a cycle equals the emptying plus filling of the syringe The syringe piston must move both the emptying and the filling the total volume taken as a reference If this is not made properly the device will detect it as incorrect maneuvers It is also convenient to perform this process in a regular way without provoking too high or too low flows The time for each cycle must not be less than three or more than six seconds 6 The screen presents the expiratory and inspiratory factors taken by the device If they are under 1 the system will be calibrated Otherwise repeat the step 5 7 Once the device is calibrated exit the Calibration program and enter the Spirometry program to start the tests Note When the parameters of calibration are entered step 3 if we assig
109. ry flow when 25 has been expired 1 5 Idem at 50 1 5 Idem at 75 1 6 Forced Mesoexpiratory Flow 1 5 Medium Flow between 75 85 of FVC s Time passed between 25 75 of FVC s Forced Expiratory Time Relation Relation Relation 1 5 Maximum Inspiratory Flow when 50 of FVC has been inspired I Forced Inspiratory Vital Capacity I Forced Inspiratory Volume in 1 second Relation Relation 1 5 Peak Inspiratory Flow s Measured Transit Time Relation I Extrapolated Volume related FVC l min Maximum Voluntary Ventilation indirect 30 x FEV1 I Forced Expiratory Volume in 6 seconds 9o Ratio Parameter that depends on the number of cigarettes smoked a day the age and FEV1 It indicates the risk of COPD 5 SIBELMED 205 User s Manual e Lung Parameter that depends on the height and FEV1 It indicates the equivalent age of the lung QC grade Quality Control Grade According to NLHEP criteria 3 2 2 QUALITY OF FVC TEST In order to assess the pulmonary function of the patient it is necessary to obtain measurements of high quality The quality of maneuvers and of the complete test depends on patient cooperation and this in turn depends on the instructions privided by the technician To ensure good quality spirometry tests the technician have to pay particular attention to ensure that the patient has made the utmo
110. s Manual 0000002 4 MAINTENANCE 511 BLO MU2 REV 1 06 a ea SIBELMED 205 Users Manual 127 The Spirometry Software SIBELMED W20s does not require any specific maintenance except that for any computer program handling information e Make a copy in a CD ROM in case the original gets damaged e Make periodical backup copies of the Data Bases used in order to be able to restore them if any loss of information occurs in the computer If any problem doubt suggestion arises before during or after the use of the product it is recommended to follow these steps 1 Usethe help windows available in the program 2 Usethis User s Manual properly 3 Check that this updated version of the program 4 Contact with the Technical Service of SIBEL S A at SIBEL S A Rosell n 500 bajos 08026 BARCELONA SPAIN TECHNICAL SERVICE Tel 34 93 433 54 50 34 93 436 16 11 e mail sat sibelgroup es 511 BLO MU2 REV 1 06 NODE s S be 11ec SIBELMED W20s User s Manual a ANNEX 1 PULSE OXIMETRY TEST OPTION 511 BLO MU2 REV 1 06 Tt SIBELMED 205 Users Manual 129 1 1 1 INTRODUCTION With the Pulse oximetry option the spirometer can perform specific measurements of the Oxygen Saturation SpO and the Pulse Rate PR or long term studies especially aimed at the control of patients during sleep or in any other situation s
111. s accessible from the main screen in Configuration Parameters and Others pulse oximetry or from the pulse oximetry tests screen in Configuration Pulse oximetry 511 BLO MU2 REV 1 06 D J TA SIBELMED W20s User s Manual 131 lt SOFTWARE SIBELMED W20s Dal Setup DataBases Options Help Setup Options Help Printer Selection Printer Selection Parameters and Others gt Spirometry Graphics and Others Maximum Pressure Links Utilities Report Header Exit About Exit The following dialogue box will appear Pulse Oximetry Setup Beep Pulse Average 5 02 d 2 9 Q The dialogue box appears updating the changes Cancel The box appears without updating the changes Help It shows the help It enables to configure the following information e Activation Deactivation of the pulse beep e Average of 5 between 4 and 16 samples The average of PR is stable 10 samples If the beeper in the pulse is activated a beep will be heard with each heart beat 511 BLO MU2 REV 1 06 Ey 2727 22 7 279428 SIBELMED 205 Users Manual 132 The averaging of 5 can be modified between 4 and 16 samples The lower the selected average value is the quicker will be the response but also more liable to variations On the contrary if the selected average value is higher the measurement will be m
112. se As it is the first time that the equipment is connected to the computer the Windows New Hardware Detected screen will appear with the name of the equipment that you have connected Select Next 511 BLO MU2 REV 1 06 a aaa SIBELMED W20s Users Manual 23 4 A screen will appear that allows you to select between two options First Find best controller for your device Second Show a list of all controllers in a location Select the Second and click on Next 5 Now a screen will appear which allows you to select between Show All Hardware or Show Compatible Hardware Select Show all Hardware and click the Use Disk button 6 If your operating system is Windows 98 select the file Di3Test in the directory D Driver_espiro W98 of the spirometry CD For others operating systems Windows 2000 Windows Windows 7 Windows 8 select the file SibelUsbEspiro of the directory D Driver_espiro WIN_x32bits Press OK 7 Click on Next and Finish The Driver will now install itself Case of Windows Vista Windows 7 and Windows 8 3 Connect the spirometer to the computer with the USB cable Consult the corresponding manual for use As it is the first time that the equipment is connected to the computer the Windows New Hardware Detected screen will appear with the name of the equipment that you have connected Select Next 4 A screen where you will read Insert the disk included
113. sed stand alone can perform a Numerical amp Graphical representation of stored measurement tests lung flows and volumes blood oxygen saturation and respiratory pressures b Diagnostic of lung flow and volume measurements Test import and export from to patient data base Furthermore the W20s Software when is used connected to the compatible DATOSPIR spirometers can perform and store in a patient data base d Signal acquisition and parametric calculus of lung flows and volumes for the diagnostic and control of respiratory diseases Asthma COPD etc Signal acquisition and parametric calculus of peripheral blood oxygen saturation and cardiac pulse for the respiratory diagnostic f Signal acquisition and parametric calculus of inspiratory and expiratory maxima pressures for the respiratory diagnostic 511 BLO MU2 REV 1 06 Tit ey Ey 2727 22 279 SIBELMED 205 Users Manual 10 1 3 INTENDED PATIENT POPULATION a Age more than 4 years until elderly b Weigth gt 15 Kg c Height gt 50 cm d Health status physical and mental condition that allows the performance of the forced expiratory maneuver 1 4 USER PROFILE The spirometry software is intended to be used by or under the direction of a medical professional Specific training on the Spirometry technique is recommended Bronchoconstriction test must be supervised by qualified technician in the art Before using the spirometry software o
114. sell 500 08026 BARCELONA Spain National 34 93 4360008 comercial sibelmed com International 34 93 4360007 export sibelmed com Technical Service 34 93 4335450 sat sibelmed com Fax 34 93 4361611 WEB www sibelmed com S belined Q 2 8 DATA BASE Spirometry Software SIBELMED W20s can work with different Data Bases This option allows to have access to the one defined in the system configuration and then to store and manage the information generated in the spirometric tests 2 8 1 PATIENT CARD Select DATA BASES PATIENT This screen allows to 511 BLO MU2 REV 1 06 5 SIBELMED W20s User s Manual 41 Sa eee Patient Card Data Base sibel 1 i x Options Index Reference 1 6 Status Day Montk Year Reference 2222121113 Birth Date 2o 19 1970 s Francisco Job analista Surname Lopez Garcia Man C Address pss de maig 290 City Barcelona Postal Code 025 Country Espa a Telephone 334360008 Mobile 324360003 Comments zl Patient Tests Par m Valor Ref 005 23 03 2005 10 28 VC 006 23 03 2005 10 28 MVV 007 23 03 2005 10 29 MVV 008 01 12 2005 11 02 PMAX DOD CO NEW Enter new patient DELETE Delete a patient and all his corresponding tests e RESTORE Restore the deleted records For this purpose it is necessary to enter DATA BASE MAINTENANCE and next t
115. serting a 1 meter tube to avoid the influence of the turbulences caused by the sudden air output according to the illustration 511 BLO MU2 REV 1 06 DU ERU E372727 227 22 SIBELMED W20s User s Manual 96 DISPOSABLE SYRINGE HOSE TRANSDUCER CALIBRATION SYRINGE 2 From the Main Menu screen click on the icon CAL x Date 20 09 2010 Technician Volume fg 1 SIBEL S A iced 200 Last Calibration Temperature 24 Rel Hum 65 X Pressure veo mmHg I oo B OK Exits the calibration updating the values Cancel Exits the calibration without updating Help Shows the help Calibrate Validates the entered data and goes to the next screen Base Shows the record of the last calibrations 3 Fill in the data of the screen according to 511 BLO MU2 REV 1 06 P NERIS S e N7C7 SIBELMED 205 Users Manual 97 e Date It takes the date automatically e Volume of calibration 1 Volume of the syringe in liters between 1 and 6 liters e Nr of Pulses only in the turbine case Number printed in the turbine corresponding to the number of pulses turn e Temperature C Value of the temperature in the room in C Humidity the same for the humidity in Pressure hPa mmHg the same for the pressure in hPa mmHg e Technician Name or code of the person who performs the calibration optional The data of the last calibration expirato
116. splay in the course of a study ISPIROMETRY SOFTWARE SIDELMED W208 Data 72 xj Setup Opos s ATELA 5 02 PR 97 065 00 01 00 Exits the menu To the left the pulse oximetry window and to the right the data window have been organized through the menu option Options Organize Windows which optimizes the space used by them In the course of a study you can e Alter the pulse oximetry configuration Hide show the data window Initialize the statistical parameters of the data window Consult Modify the test data e Store the parameters Print a report of the study When the estimated time of study has passed press again key START to store the test and update the data 511 BLO MU2 REV 1 06 SIBELMED 205 Users Manual 136 A SPECIFIC TESTS In the specific pulse oximetry tests the screen will indicate the SpO PR values according to the configured average If you want to store the data in the data base or print them stop the study and proceed according to the manual B LONG TERM TESTS In long term tests the statistical data calculated are useful for the observation of the patient s evolution without being present all the time It is important to point out that the signal is associated to the patient s code entered If you start and stop the study before changing the
117. st effort that the start has been good and that no coughing or Valsava s maneuver due to glottis closure has occurred Special attention must be paid for preventing an early termination of the expiration The SIBELMED W20s Spirometry Software includes quality alerts to assist you in producing high quality spirometry tests These alerts are based the recommendations of ATS ERS o NLHEP National Lung Health Education Program which can be selected from the menu SETUP PARAMETERS AND OTHERS SPIROMETRY menu I ATS ERS ALERTS The ATS ERS recommendations define the following acceptability criteria for the maneuvers based on the start and end of test Once the maneuver is finished one or two warnings may appear on the screen indicating that the maneuver has not been performed according to the ATS ERS criteria 511 BLO MU2 REV 1 06 Tt ae Ey 2727 22 279 SIBELMED 205 Users Manual 111 ET It indicates that expiration did not end satisfactorily This alert is based on two criteria EOTV It indicates that the variation of accumulated volume during the last 2 seconds of the maneuver was greater than 25 ml FET It indicates that the maneuver lasted less than 6 second in individuals of 10 years or older or less than 3 seconds in children under 10 years The ET alert is indicated when one or both of these criteria are met EX It indicates that the expiration did not start satisfactorily because the extrapolated vol
118. st_W20sLink T est_W20sLink exe 9 Q Q This option allows the user to select the following e PDF Path where the generated PDF file is saved XML Path where the generated XML file is saved File name format both PDF as XML files e Autosave PDF file to save it automatically without showing the corresponding dialog box e SibelHL7link 511 BLO MU2 REV 1 06 a ea S e N7C7 SIBELMED 205 Users Manual 35 This option allows you to convert the XML file to CDA format of spirometry which can be viewed through a browser and use a work list with the scheduled patients This option is only available if the W20sLink option is purchased The Local Server options allow you to configure if the SibelHL7link application is installed on the same computer where is installed the W20s or on a remote computer External Bridge Application This option allows linking the W20s with a proprietary application of the client that generates the work list with the scheduled patients and export the generated PDF and XML files to external systems This option is only available if the W20sLink option is purchased Automatic Manual options allow you to configure if the external bridge application is executed automatically for example applications that run in the background or must run from the W20s In the second case you must indicate its path and name in the External Bridge Application field and must be run using t
119. t The most influential factor is the temperature followed by the humidity degree The DATOSPIR 600 has integrated a Calibration Program which in a quick and easy way less than two minutes allows verifying and self correcting the deviations of the measurements performed The periodicity of the calibration depends on the user criteria SIBEL S A as the manufacturer recommends according to the different standards a daily or weekly calibration 511 BLO MU2 REV 1 06 5 SIBELMED W20s User s Manual TRANSDUCER TYPES DATOSPIR 600 can work with three different transducer types Pneumotachometer Fleisch Turbine Transducer Disposable Transducer The pneumotachometer Fleisch type is the system of flow measurement with the highest acknowledgment in the pulmonary field due to its great reliability reproducibility and duration The Turbine Transducer type is a system of good reliability and reproducibility Its duration is limited to the use and care applied to the transducer The Disposable Transducer type is a reliable element and of good reproducibility Its use is adequate in cases where it is necessary to avoid possible infections between patients caused by undetected or not eradicated contaminations due to lack of cleanness in the used pneumotachometer or transducer PROCESS OF THE CALIBRATION The steps to follow are 1 Connect the pneumotachometer or transducer to the syringe in
120. t start as described in the ENTERING PATIENT AND ENVIRONMENTAL PARAMETERS section 2 Train the patient about the performance of this kind of 511 BLO MU2 REV 1 06 DU ERU TEE E3727 7 22722228 SIBELMED W20s User s Manual 77 test as his collaboration is essential for its correct execution 3 The maximum time to perform the maneuver is 15 seconds The device stores a maximum of eight maneuvers ordered according to the MVV value and being M1 the one of highest MVV and M8 the one of lowest 4 The graphic is represented in Volume Time mode and there is no motivation graphic 5 The report with the parameters and graphics is displayed next fisPiROMETRY SOFTWARE SIBELMED W20s Data Base sibel loj xj Setup Options Help ass s 25 ell 23 Manoeuvres Summary Reference 1111111111 Lopez Garcia F _ PARAMETER pal 2 5 6 REE e l min 144 01 175 70 s2 Br Min 44 36 MYY Graphic Starts or Ends the manoeuvre 511 BLO MU2 REV 1 06 Ey 2727 22 7 279 428 SIBELMED W20s Users Manual 78 LUNG FUNCTION REPORT Reference 1111111111 Date 20 09 2010 Time 11 07 Name Lopez Garcia Francisco Sex 35 Height cm 180 Wgt Kg 75 Temp C 25 Pres mmHg 760 Humidity 65 Smok I Motive BMI 23 1 Procedence Technician Transducer Demo References SEPAR Ethnic F 100 Version 511 BLA1 0 MVV REPORT Maneuver Nol SIBE
121. ta Base sibel nl x Setup DataBases Options Window Help LM Patients Manoeuvres 0 Reference Name Date Time 20 09 2010 10 20 002 2222222222 Sanchez Grau Maria 20 09 2010 10 25 003 3333333333 Marcos Fernandez Juan 20 09 2010 10 30 004 4444444444 Mir Perez Anna 20 09 2010 10 37 005 5555555555 Ramos Garcia Pedro 20 09 2010 10 42 006 6666666666 Pardo Miret Jos 20 09 2010 10 48 20 09 2010 10 59 27 10 2010 12 25 Mark It will activate the stand out patient or test in the operative window Unmark It will deactivate the patient or the test Mark all All the patients will be activated if the operative window is Patients or all the tests of a particular patient if the operative window is Patient s Tests Unmark all It will unmark all the patients or all the tests of a particular patient EXPORT Once the tests are selected perform the action of export by entering the option of the menu Options Export to disk or by clicking over the key EXP in the tools bar Select the folder and file of destination and press Accept A bar will appear which will indicate you about the percentage of the performed export 511 BLO MU2 REV 1 06 S be N7CT SIBELMED W20s User s Manual 89 In the selected destination directory the files PRUEBAS CSV PATIENT CSV GRAF001 CSV GRAFOO2 CSV If these files were existent they will be deleted and r
122. ule from the patient card in the data base the program will only present the window Patient Maneuvers 2 14 2 EXPORT DESTINATION The destination subdirectory used as default by the program is TMP of the directory where the program was installed The tests data are stored in the file PRUEBAS CSV patient data are stored the PATIENT CSV and the pressure graphics points associated to the tests are stored in the files GRAF001 CSV GRAF002 CSV The destination directory and the name of the file where 511 BLO MU2 REV 1 06 M Em Ey 2727 22 2294288 SIBELMED 205 Users Manual 87 the tests are stored can be changed entering the export module by pressing the EXP icon or going to the Export to Disk option in the Options menu txport file Definition Nombre PRUEBAS coy tS Tey Files C9 When activating the Check box of a patient all his her tests will be automatically activated In this example the aim is to export all the tests from patient 2 In order to check all the selected tests of a certain patient click over its reference or name outside the area of the Check box In the Patient s Tests window the selected tests will appear with a mark The tests and the patients can also be selected for its export through the sub options in the menu Selection 511 BLO MU2 REV 1 06 S be N7CT SIBELMED 205 User s Manual 88 7isPIROMETRY SOFTWARE SIBELMED W20s Da
123. ume was greater than 5 of the FVC or 0 15 liters whichever is greater A These alerts may be disabled in the SETUP PARAMETERS AND OTHERS SPIROMETRY menu In this case they will also be removed from the printed report This disabling is only at display level The warnings are still taken into account when ordering the maneuvers and will be displayed in the Maneuver Data window II NLHEP ALERTS QC PROMPTS The SIBELMED W20s software includes an automatic quality control function based on the recommendations of the NLHEP National Lung Health Education Program with prompts to assist the technician in providing instructions to the patient to produce high quality spirometry tests At the end of a maneuver a message on the screen will inform you about the acceptability of the maneuver If it is considered not acceptable provide instructions to the patient for improving the maneuver based on the messajes indicated in the following table see the rows in white 511 BLO MU2 REV 1 06 S be 1N7eC SIBELMED W20s User s Manual When the message Good test Session appears it is not necessary to carry out further maneuvers If after repeated attempts it is not possible to obtain an adequate number of good maneuvers let the patient take a break or stop the measurement A Only one of the following QC prompts is displayed after a performed maneuver in the order of priority listed below QC Prompt Criteria How t
124. ust be in open position in order to enable the patient to breathe normally OPEN lt gt CLOSED Once the patient has reached the position of Total Pulmonary Capacity move the cursor to the closed position and perform the maneuver TESPIROMETRY SOFTWARE SIBELMED W20s Data Base sibel ig Setup Opbons Starts or finishes the maneouvre 511 BLO MU2 REV 1 06 DUREE UE S Ey 2727 22 229 SIBELMED W20s Users Manual 147 4 Once the maneuver has finished repeat the step 3 to perform additional maneuvers It is advisable a minimum of 3 maneuvers The best 3 must not differ more than 5 9o among them and the last one must not be the best A2 4 2 PERFORMANCE OF SNIFF TESTS If you have purchased the SNIFF probe you can perform as well the peak nasal pressure test The procedure is similar to the MIP MEP test described above 1 Connect the connection module through the phone connector to the socket no 12 located on the rear of the Spirometer The equipment detects automatically that the module is connected If the module is not connected the equipment will show it on screen and it will not allow entering the screen of tests performance 2 Connect the SNIFF probe to MIP MEP connections module 3 Instruct the patient on the test performance since their cooperation is essential for proper implementation 4 Place the nasal olive in the nose of the patient 5 t
125. ving selected the option Save 3 best maneuvers on SETUP graphics and other REF Reference predicted normal Value between PRE REF POST Postbronchodilation Value or POST1 POST2 POSTS in case of having selected the option Save 3 best maneuvers on setup graphics and other 9oP between the POST PRE or other according to setup R between REF and POST It appears depending on the configuration of the previous parameter 511 BLO MU2 REV 1 06 ey ear a SIBELMED W20s User s Manual 69 WARNINGS SYMPTOMS Allows noting down events like cough weezing dyspnea or sputum that the patient may experience during the test Each of these symptoms can have the following values White No symptom Green Mild symptom Yellow Moderate symptom Red Severe symptom BEST It show the highest values of FVC and FEV1 from those maneuvers with and acceptable start without EX alert SELECTED MANEUVER It shows the number of the selected maneuver that is displayed on screen Any available maneuver can be selected up to a maximum of eight The order of the maneuvers is presented according to the ATS ERS criteria or the NLHEP criteria depending on what is selected in the menu Setup Parameters and Others Spirometry based on the errors of each maneuver and on the highest value of being number 1 the one with less errors and or highest addition the best maneuver and number 8 the one with
126. with your device will appear select I don t have the disK Show me other options NOTE device is your spirometer model 5 Now a screen will appear that allows you to select between two options select Browse my computer for driver software 511 BLO MU2 REV 1 06 ERU SIBELMED W20s User s Manual 24 6 If your operating system is a Windows Vista 32 bits version select the directory D Driver_espiro WIN_x32bits of the spirometry CD For Windows Vista 64 bits select the directory D Driver_espiro WIN_x64bits Press OK 7 Click on Next and Finish The Driver will now install itself 2 4 5 SETUP Start the PC and run the program Press once over the icon W20s found inside the folder of the start menu Programs SIBEL Press OK on the screen ABOUT to enter the MAIN MENU Connect the spirometer to the computer 2 4 6 SPIROMETRY SOFTWARE UNINSTALLATION 1 the CD ROM the CD ROM reading unit 2 If the PC s CD ROM drive unit has the auto run option active it will run to the automatic installation otherwise the program Setup exe should be executed after acceding to the corresponding CD_ROM unit 3 next options can be chosen when the following window appears 511 BLO MU2 REV 1 06 SPIROMETRY SOFTWARE SIBELMED W205 Welcome Repair or remove the program rogram This program lets you madity the Sibelm
127. work list must be generated from the external Information System HIS Then SibelHL7link or the External Bridge Application are responsible for transferring the work list to the W20s 511 BLO MU2 REV 1 06 at Ea S be N7eC7 SIBELMED W20s User s Manual 2 9 2 ENTERING FORCED VITAL CAPACITY TESTS PIROMETRY SOFTWARE SIBELMED W20s Doka Base SANE xj This screen is the essential core where the spirometric maneuvers are performed In this case the axes for the Flow Volume Graphics and Volume Time as well as the incentive plot are showed The user can select other option by entering SETUP GRAPHICS AND OTHERS If the graphics windows are not adjusted to the size of the general window or if they are not organized we click on OPTIONS ORGANIZE WINDOWS and they are adjusted to the program automatically In this screen the following parts or windows can be pointed out MENUS The SETUP menu allows to Printer Selection Check SETUP PRINTER SELECTION Parameters and Others Check SETUP SELECTION OF PARAMETERS 511 BLO MU2 REV 1 06 5 SIBELMED 205 Users Manual Graphics and Others Check SETUP GRAPHICS SELECTION Transducer Code Option to be activated when it is a disposable transducer Bronchoconstriction Option to be activated if the Bronchoconstriction module is installed Exit The OPTIONS menu all
128. y 25 Pres mmHg 760 SEPAR SPAIN 1 086 511 BLA 1 05 511 BLO MU2 REV 1 06 E3727 7 22722228 SIBELMED W20s User s Manual Date NW BU 09 05 2014 11 17 Height cm 175 Wgt Kg 76 Humidity 65 5 BMI 24 8 Transducer Disk Ethnic F 100 2 4 6 8 10 12 14 16 18 20 22 24 CU ER REUS L37277 22722228 SIBELMED W20s User s Manual 74 Report It allows printing the report Forward Backward It allows advancing or moving back through the report to visualize each one of its sheets Help It allows entering to the preliminary view help Return It allows getting back to the previous screen 2 10 SLOW VITAL CAPACITY VC TEST PROCEDURE The procedure to perform the slow Vital Capacity test is similar to the one described in the FORCED VITAL CAPACITY FVC TEST PROCEDURE section but with the following variations 1 If the test is made to the same patient activate the icon VC and start the series of spirometric maneuvers If it is a new patient start as described in the ENTERING PATIENT AND ENVIRONMENTAL PARAMETERS section 2 Train the patient about the performance of this kind of test as his collaboration is essential for its correct execution 3 The maximum time to make the maneuver is 60 seconds The device stores a maximum of eight ordered maneuvers according to VC value and being M1 the one of highest VC and 8 the one of lowest 4 In
129. y The user can adjust the sizes manually by using the mouse and moving any side or edge of a window Exit Allows to exit from this screen ICONS Through the corresponding icons we can have access to the options previously described except the ones of Test Data and Organize Windows Moreover there is an icon available to visualize a preliminary view of the report SUMMARY OF THE MANEUVERS DATA Forced Vital Capacity Mode It shows the parameters FVC FEV1 PEF and FEF25 75 of the eight best performed maneuvers 1 8 as well as the best values according to ATS criteria green color the Reference value and 9o of the best values according to the Reference value In POST bronchodilation mode the Reference values are changed by the ones obtained in PRE bronchodilation mode The maneuvers are ordered from best M1 to worst M8 according to the ATS criteria of the maximum addition of and according to the detected errors in each maneuver The labels M1 M8 indicate the color for the associated 511 BLO MU2 REV 1 06 T a 5 SIBELMED W20s User s Manual graphic The square brackets e g M3 indicate the position taken by the last performed maneuver Slow Vital Capacity Mode It shows the parameters of VC test VC VT and ERV Maximum Voluntary Ventilation Mode It shows the parameters of MVV Test MVV and Br min GRAPHICS Presents the graphic windows selected in GRAPHICS AND OTH

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