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SIBELMED W-20

1. 73 VISTA PRELIMINARY 22222 78 PROCEDURE FOR SLOW VITAL CAPACITY VC 79 PROCEDURE FOR MAXIMUM VOLUNTARY VENTILATION 82 BRONCHODILATION 56 6 84 IMPORTING TESTS FROM THE SPIROMETER 87 EXPORT OF TESTS TO OTHER 5 5 5 89 ORGANIZATION OF THE 5 90 EXPORT DESTINATION nnn 91 seeks E 92 EXPORT TESTS TO MAIL 93 IMPORT OF TESTS FROM A REMOTE CONSULT 93 DISPLAY OF RESULTS THROUGH OTHER SYSTEMS 95 EXPORT FROM THE DATA 96 PROCEDURE FOR PERFORMING THE CALIBRATION 97 ACTIVATION CODE 105 SOFTWARE PURCHASE 54 5 3255523335235234528232 106 UPDATE OF THE DEVICE S SOFTWARE W20s 107 UPDATE SOFTWARE OF THE 108 DOWNLOAD DATA OF THE 109 TECHNICAL SUPPORT 2 5250 111 2 TECHNICAL 5 65 113 Sibelmed SIBELMED W 20 User s Manual 5
2. ee a Ber Htm mma mm cadem pe HO DR em D ee kai EL Famam Be PI _ LEE ELLE M You must select the Bluetooth Series Port service so that the device installed in the computer can communicate with the spirometer Other services may be needed to communicate with other devices that have Bluetooth mobile phones another computer 4 COM port assigned to the Bluetooth device and deactivating the secure connection 25 SIBELMED W 20 User s Manual Chapter 1 Instructions of use and instalation Chapter 1 Instructions of use and instalation sibelmed SIBELMED W 20 User s Manual Once Windows has finished configuring the Bluetooth device you can click on the icon at the bottom right and all the installed services will appear One of them will be the Bluetooth Series Port Service The following screen will appear when you select Advanced configuration with the mouse CUm lewis deo ieee eee Se Eim ha uea _ eee byn __ ore ieee m GELGC 1 E iam eee pe ee Fei the H ee ke ee oe SIBELMED W 20 User s Manual 5 pue asn Jo suoipnajsug 19429 Sibelmed SIBELME
3. 161 PRINTING AND OR MEMORISATION IN THE DATA BASE 167 ANNEX 3 BRONCHOCONSTRICTION BRONCHIAL PROVOCATION 171 PROCEDURE FOR THE BRONCHOCONSTRICTION OR BRONCHIAL PROVOCATION TEST 172 TEST DESCRIPTION nt rennen nia eaae 172 ENTERING TEST eor ER etre ep sehe 174 PROCESS OF THE TEST t rnt rrr xs 175 SUMMARY PRINTING and or STORING OF THE TEST 182 ANNEX 4 COMPLIANCE WITH THE DATA PROTECTION ACT DIRECTIVE 95 46 EC eren nnne nennen nnn 185 ANNEX 5 65 195 Sibelmed SIBELMED W 20 User s Manual 7 DECLARATION OF CONFORMITY The SIBELMED W 20 Spirometry Software has been developed by the R D department of SIBEL S A in collaboration with the Laboratorio de Funci n Pulmonar del Hospital de la Sta Creu i Sant Pau de Barcelona and according to the Quality Management Manual of SIBEL S A in concordance with the quality norms ISO 13485 and ISO 9001 2000 as well as the European Directive for Medical Devices 93 42 CEE According to this directive it is considered as a class IIa product 0318 PRODUCT ACCORDING TO 93 42 EEC Medical Device Directive Class IIa Revised Approved Date May 2012 Date May 2012 dT d Jos
4. an intermediate memory in PREbronchodilation mode to perform a later POSTbronchodilation test e WARNING The manoeuvre selected in the screen is stored Remember that the best manoeuvre is number one and that is why we recommend to select it previously REPORT It allows getting a report of the manoeuvre selected DIAGNOSIS It presents the diagnosis of the selected manoeuvre The type of diagnosis be selected SETUP PARAMETERS AND m OTHERS SELECTION DELETE It allows deleting the selected manoeuvre sibelmed SIBELMED W 20 User s Manual 72 TYPES OF DIAGNOSIS The Spirometry Software SIBELMED W 20 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 LyonsDiagnosis 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 FEVi FVC lt FEV1 FVC Reference and FEV1 lt 80 of FEV1 Reference gt Ventilatory alteration of Obstructive type FEV1 80 Light FEV1 65 Moderate FEV1 lt 50 Strong FEV1 359 o Very Strong e If gt FEV1 FVC Reference and lt 80 of FVC Reference Ventilatory alteration of non Obstructive type FVC 80 Light FVC lt 65 Moderate FVC
5. Hw Venns ut VC and VV Parweeters 9 i t a 9 mov feta TV n owt lv Ur c9 T amp oh Tes Te Tnterprezacion Predicted Dilaeion Disabled Muse Chi deen t Miller Ding 125 jot pee v guider Mery Licks Diag ATR ERE Factor 7109 v Cabibrecion f Quality Control 20 9 This option allows the user to setup or select the following e FVC Tests Parameters e VC and MVV Parameters Type of Diagnosis Miller Diagnosis Snider Kory amp Lyons Diagnosis e ReferenceParameters to be selected for Adults and Children Among them we find 5 pue ASN Jo 5 T 1e3deu sibelmed SIBELMED W 20 User s Manual 38 Among them we find SEPAR Multicentre of Barcelona ECCS ERS KNUDSON CRAPO ZAPLETAL MORRIS AUSTRIAN GUTIERREZ CHILE BRAZILIAN POLGAR WENG HANKINSON PEREZ PADILLA MEXICO A J CRUZ MEXICO GOLSHAN IRAN It is possible to include other references For this purpose contact with SIBEL S A e Ethnic Factor The ethnic factor modifies the References values according to the selected percentage If no correction is to be included the factor must be 100 e Comparing mode in the Bronchodilater Tests Average between PRE and POST 100x2 POST PRE POST PRE between REF and POST 100 POST REF
6. Chapter 1 Instructions of use and instalation Ssibelmed SIBELMED W 20 User s Manual 88 The screen presents the following information Nr Number of test order Reference Corresponding to the patient Type Corresponding to the type of test being FVC Forced Vital Capacity Slow Vital Capacity MVV Maximum Voluntary Ventilation Dilat PostBronchodilater Test in FVC mode P1 and P2 Parameters corresponding to P1 P2 FVC 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 orientative for the user The information transferred is stored in the operative Data Base at that moment and in each corresponding patient card sibelmed SIBELMED W 20 User s Manual 89 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 ja SPIROMETRY SOFTWARE W 20 ikasa bel T Options Explore Data Base Martenerce 2 tet Cv format By entering this option the program opens the exploring window SPTROME PRY SOFTWARE SIDEIMED W 29 2222222222 rau 2340 2085 3331333333 13022985 4441447444 2203 2085 502252844 2
7. TUER 429 9 000990 The maximum and minimum values of alarm for the SpO and PR are displayed respectively 15291 os nd T X3NNV Sibelmed SIBELMED W 20 User s Manual 144 The values for SpO2 and of PR will be painted in dark blue when they are in the allowed values in yellow for the SpO2 D if it is situated at 5 of the minimum value and for the PR if it is situated at 5 of the maximum minimum value If the limit values are surpassed the digit will be painted in red and a warning of SURPASSED ALARM will be displayed in the lower part of the screen If the Acoustic Warning is 3 activated a sound warning will also be heard The message in yellow APPLY THIMBLE PROBE can also appear when peripheral pulse wave is detected In this case the values SpO2 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 This screen shows an example of display in the course of a study aiaia 5 009049 1 97 065 155 6 i29 _ 40 022105 To the left the pulseoximetry window and to the right the data window have been organised through the menu option Options Organise Windows which optimises the space used by them Sibelmed SIBELMED W 20 User s Manual 145 In the course of a study you
8. Agety Cuv 111111111 Biren dere 0 fio Trends reanciees nalista Lopes Garcia maig 290 Ciny Farani ona Fostal Code non Taleprome 55430009 54360005 E baniwnn Testa Pasin Valos Fet 0 403 22 05 2005 10 28 VC 004 23 03 2098 10 29 005 01 11 2008 11 02 PMAN YOO 2x Also from the Patient test card the option Export can be entered 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 TMP of the directory where the program was installed and it is stored as PRUEBAS CSV The previously exported tests will be deleted SIBELMED W 20 User s Manual 97 Per Your Tea Dus aene mee fep fee o mem r r r D r r Be neo PROCEDURE FOR PERFORMING THE CALIBRATION The Spirometry Software SIBELMED W 20 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 user interface and the calibration is done through this software PROCEDUR
9. Ini sj SEPEN __ Fe teres the Hews 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 manouvre begins e At any time when the chronometer is on you can click on it to either stop the count down reset it or stop the alarm The action taken over the chronometer depends on its state Store the best manoeuvre in a similar way to the previous steps once the manoeuvres of the constrictor step have been performed 1591 10 3214135 XANNV ANNEX 3 Bronchoconstriction or bronchial provocation test Sibelmed SIBELMED W 20 User s Manual 180 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 diluent has not been made the graphic dose response shows the value for PD20 8 0 0 0 4 4 0 40 0 hb The graphic dose response is shown mathematically adjusted by means of a logarithmic function y 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 adjustm
10. 34 SOFTWARE CONFIGURATION 36 PRINTER SELECTION oett n err nis 36 PARAMETERS DIAGNOSIS REFERENCES AND OTHERS 37 GRAPHICS PEDIATRIC MOTIVATION AND LANGUAGE SELECTION pec EE 40 SOFTWARE Fete 41 DEVICE CHECK nn xs 42 UTILITIES ir ire teer REDE RIEF MER sans 43 ABOUT e donee Une duke rm M 44 DATA BASE 45 PATIENT CARD eR E Ra a RR 45 EXPLORE Pet ete enters dk eni eia 50 DATA BASE 444 56 EXPORT CSV FORMAT 57 Index Sibelmed SIBELMED W 20 User s Manual 4 IMPORT CSV FORMAT TESTS eene 58 PROCEDURE FOR FORCED VITAL CAPACITY FVC 60 ENTERING PATIENT AND ENVIRONMENTAL PARAMETERS 60 ENTERING FORCED VITAL CAPACITY TESTS 63 MANOEUVRE aan 68 TYPES OF 15 0 4 9 1 72 PRINTING
11. Chapter 1 Instructions of use and instalation sibelmed SIBELMED W 20 User s Manual CALIBRATION xj Fleisch OK 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 Espiratory factor Inspiratory factor Calibration volume Technician who performed the calibration Sibel med SIBELMED W 20 User s Manual 105 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 VALIDATION OF THE SOFTWARE xj WAHNING u Youhave 29 days tousa kil EE oio OCHO Mods the lime showed te vhat is bell to use spine options of 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 5 pue ASN JO SUOI JINAYSUT T 1e3deu Chapter 1 Instructions of use and instalation Sibelmed SIBELMED W 20
12. LS E 2 POU CELA TING A MANCINI eei VOU PT 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 manoeuvres and adjust the graphics to the desired size 150 200 100 1111111111 maxi 203 1 ES 231 219 Avegage 219 Sid Dev 14 Reference eManoeuwe Average P MORALES 15291 sainssaid 1 z XaNNV Sibelmed SIBELMED W 20 User s Manual 166 It is useful for the comparison of the manoeuvre 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 screen 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 Sibelmed SIBELMED W 20 User s Manual PRINTING AND OR MEMORISATION IN THE DATA BASE The system displays stores or prints the values for all the manoeuvres On the contrary only the curve for one manoeuvre is printed or
13. 0 969 Pressure 750 mmHg Date 06 11 2005 I 60 Exits the calibration updating the values Cancel Exits the calibration without updating Help Shows the help Calibrar Validates the entered data and goes to the next screen Base Record of the last calibrations 3 Fill in the data of the screen according to e Date It takes the date automatically e Volume of calibration Volume of the syringe in litres between 1 and 6 litres 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 e Humidity the same for the humidity in e Pressure mmHg the same for the pressure in mmHg e Technician Name or code of the person who performs the calibration optional The data of the last calibration espiratory and inspiratory factor and date are not modifiable it presents the ones available in the device Chapter 1 Instructions of use and instalation Sibel med SIBELMED W 20 User s Manual 102 Click on the Calibrate key I xi FSPF INSP F 2 Ome If there is a disposable connected the next window will appear Calibration Disposable Dis Fct 4657 4 Make sure that the neumotachometer 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
14. 50 Strong FVC 35 Very Strong e If FEV1 FVC9o gt FEV1 FVC9 o Reference and FVC gt 80 of FVC Reference Ventilatory alteration of Mixed type suspected Sibe med SIBELMED W 20 User s Manual e If FEV1 FVC lt FEV1 FVC Reference and FEV1 gt 80 of FEV1 Reference 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 There is a positive reaction to the bronchodilater substance PRINTING REPORT It is possible to make a report of any manoeuvre performed This option is found in the Manoeuvre Data window in the MANOEUVRE 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 an d graphics in both modes are displayed next 5 pue esn Jo SUOIJINAJSUL mon talat ins f use and 1ons o Instruct Chapter 1 Ssibelmed SIBELMED W 20 User s Manual LUNG FUNCTION REPORT Reference 1111111111 Name Lopez Garcia Francisco Sex Man Age y Temp C 25 Pres mmHg Motive Procedence Technician References SEPAR Ethnic F Version 51176FA 3 0 FVC REPORT PARAMETER OBS REF 3 Best FVC 1 5 99 5 64 106 Best FEV1 1 4 26 4 40 97 FVC 1 5 99 5 64 106 0 5 1 2 15 FEV1 1 4 26 4 40 97 PEV3 1
15. e Procedence or centre departament 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 m per Pm When pressing the type of test is selected this case FVC Sibelmed SIBELMED W 20 User s Manual ENTERING FORCED VITAL CAPACITY TESTS This screen is the essential core where the spirometric manoeuvres are performed In this case the axis for the Flow Volume Graphics and Volume Time as well as the motivation 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 Graphics and Others Check SETUP GRAPHICS SELECTION Sibelmed SIBELMED W 20 User s Manual 64 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 allows to Manoeuvre Start START Icon When activating
16. 5 86 FEVO S FVC 45 93 FEV1 FVC 71 14 78 92 90 FEV3 FVC 97 1 FEV1 VC 126 72 PEF 1 s 6 50 10 51 62 MEF25 1 5 1 80 2 03 89 MEF50 1 5 3 78 5 52 69 MEF75 1 8 5 61 FEF25 75 l s 3 42 4 39 78 FEF75 85 1 s 1 48 FET25 75 s 0 88 FET100 s 5 31 MEF50 MIF50 1 01 0 66 153 MTT s 0 82 FEV1 FEVO 5 1 55 1 45 107 FEV1 PEF 3 10 93 6 64 165 50 1 3 3 75 FIVC 1 5 99 1 1 4 26 FIV1 FIVC 71 16 FEV1 FIV1 1 00 0 80 125 PIF l s 6 50 PEF PIF 1 00 1 39 72 Vext 8 0 05 MVV Ind 1 127 84 FEV6 1 5 99 FEV1 FEV6 71 14 COPD index 0 00 Lung Age 30 84 Warning TT Diagnosis Miller s Diagnosis Manoeuvre Nol 28 12 2005 Time 11 09 Height cm 180 Wgt Kg 75 Humidity 65 Smok I BMI 23 1 Transducer Disk 100 SIBELMED W 20 Obstructive ventilatory alteration Chapter 1 Instructions of use and instalation g 4 z N gt FU 3 s H IU 8 Lo i o i LI R 9 4 ki Ls 3 S ES 1 a m uo 1793 N gt a gt 7 Y 2 5 5 9 E 5 k 5 m Chapter 1 Instructions of use and instalation Sibelmed SIBELMED W 20 User s Manual PRUEBA DE FUNCION PULMONAR Referencia 12470 Fecha 27 07 2000 Nombre LOPEZ SANCHEZ FERNANDO Sexo Hombre Edad a 38 Talla cm Temp 22 Pres mm
17. SOFTWARE 114 TYPES OF TESTS FUNCTIONS AND SPIROMETRIC 115 FORCED VITAL CAPACITY 115 SLOW VITAL CAPAGCLITY 117 MAXIMUM VOLUNTARY VENTILATION 118 POSTBRONCHODILATION 118 BRONCHOCONSTRICTION 119 PROGRAM CONFIGURATION eene 120 DATA BASES teats 120 MEASUREMENT 5 5 121 ANALYSIS CRITERIA 122 ELECTRONIC WEATHER STATION 123 MAXIMAL PRESSURES MODULE 124 PARAMETERS 5 2 ne rt Rr er 124 RANGES AND 124 COND ROL wisest eiit qr Yan n 3 124 PULSE OXIMETRY 126 TESTS AND PARAMETERS nre e ster Rex 126 RANGES AND 127 CONTROL vaste eter 127 GENERAL 1
18. 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 REINDEX It allows to reorder 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 definetely 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 Wa
19. 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 CSV and GRAFxxx CSV Usually 001 5 B TRANSPORT These files will be sent by e mail or Chapter 1 Instructions of use and instalation Sibelmed SIBELMED W 20 User s Manual 94 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 THY SOFTWARE 20 ate Setup Optxrw n frr Osta fane Matea E spon foem The following window appears 2204 5 1112211111 41 10 29 05 21 TED TTD ia Click with the mouse over the tests to be imported to the data base of the spirometry software SIBELMED W 20 or click over the key S All in order to select all the tests Click over the OK key The program will show the percentage of the import sibelmed SIBELMED W 20 User s Manual PTT TT 2 5 DISPLAY OF RESULTS THROUGH OTHER SYSTEMS The information of the generated files are fields between inverted
20. 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 e Warnings If this option is activated some indications appear in the report when the spirometric manoeuvre does not meet the ATS criteria The indication can be TP Indicates that the espiration has had a lower duration than six seconds The ATS recommends six or more seconds Sibelmed SIBELMED W 20 User s Manual 39 FP Indicates that the espiration has not ended satisfactorily as the accumulated volume of variation in the last second of the manoeuvre is superior to 0 03 litres The ATS recommeds less than 0 03 litres EX Indicates that the espiration start has not been satisfactorily as the extrapolated volume is superior to 5 of the FVC or 0 15 litres The ATS recommends to be inferior to 5 of the FVC or 0 15 litres the highest The Spirometry Software SIBELMED W 20 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 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
21. 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 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 GRAFO01 CSV column 23 Chapter 1 Instructions of use and instalation sibelmed SIBELMED W 20 User s Manual 96 EXPORT FROM THE DATA BASE The program offers the option of exporting 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 Patent Card Data Baer iiaiai xj tans Delete be ference EN Mont
22. Manual 70 8 the one of lowest addition the worst Other criteria are also taken into account for the order regarding the manoeuvre quality as the Manoeuvre Time Manoeuvre Final Start Warnings The label Act Indicates the order or position taken by the last performed manoeuvre WARNINGS In each manoeuvre it is indicated if any of the following ATS criteria does not meet TP Indicates that the espiration has had a duration inferior to six seconds The ATS recommends 6 or more seconds FP Indicates that the espiration has not ended satisfactorily as the accumulated volume variation in the last second of the manoeuvre is superior to 0 03 litros The ATS recommends less than 0 03 litres EX Indicates that the espiration start has not been satisfactory as the extrapolated volume is superior to 5 of the FVC or 0 15 litres The ATS recommends that it should be inferior to 5 of the FVC or to 0 15 litres the highest REPRODUCTIBILITY If three or more manoeuvres have been performed with the FVC and or FEV1 parameters activated they warn that the reproductibility criterion is met for one or both parameters This criterion indicates that both observed best values of FVC must not differ more than 0 2 litres and the same happens for FEV1 Besides the previously said the following can be made from this screen STORE 6 SIBELMED W 20 User s Manual 71 1 7 It stores the tests in the Data Base
23. Maria Plana Carlos Recio Technical Manager Sales Manager Declaration of Conformity Ssibelmed SIBELMED W 20 User s Manual Sibelmed SIBELMED W 20 User s Manual 9 1 INSTRUCTIONS OF USE AND INSTALATION uolejejsul pue asn Jo suoinajsug 19429 Chapter 1 Instructions of use and instalation Ssibelmed SIBELMED W 20 User s Manual INTRODUCTION The SIBELMED W 20 is a software 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 120 and it can work in real time or diferred time depending on the spirometer characteristics It allows among other functions The management of different Data Bases The performance of FVC VC MVV and Postbronchodilation tests The 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 with children jbelmed SIBELMED W 20 User s Manual 11 PREVIEW This product is manufactured under strict quality controls Nevertheless accidents may happen in the transport or storage so it is convenient to make a status check before installing it as well as of its accessories The Spirometry Software SIBELMED W 20 consists of CODE QUANT DESCRIPTION 511 8F0 000 1 Spirometry
24. PEF These indications only appear if the Reference values exist The PEF is placed at 10 of the FVC Reference volume MOTIVATION The motivation is a graphic possibility useful for motivating children during the performance of spirometric manoeuvres 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 2 Train the patient about the test performance as his collaboration is essential for its correct proceeding The patient can perform the manoeuvre in two different ways e The first consists of starting the manoeuve over the transducer with the FORCED ESPIRATION followed by the FORCED INSPIRATION if needed SIBELMED W 20 User s Manual e The second consists of the patient breathing normally through the transducer and when the technician indicates it fill the lungs completely and then start the FORCED ESPIRATION followed by the FORCED INSPIRATION if needed Indicate the patient the most convenient way of taking the transducer without obs
25. as long as it is not modified Chapter 1 Instructions of use and instalation Sibelmed SIBELMED W 20 User s Manual 40 GRAPHICS PEDIATRIC MOTIVATION AND LANGUAGE SELECTION Select the option GRAPHICS AND OTHERS inside the SETUP xi Graphic Deport Zeresen Graphics Data it Graphice Curve v Curve Curva Score Graphics Curve 7 Curve iv curve r ZI Pos incentive Language Activated 1 Test 1 Deference 100 021126 Rocket v Other Test of thw Bert 100 Sound Varning r This option allows the user to select the following e Graphics in the Printed Report Curve F V Curve V T Curve VC Curve MVV e Graphics on the Screen Curve F V Curve V T Curves F V and V T e Store graphics in the DATA BASE e Motivation for pediatric tests To be selected among different pictures To be selected the level of the motivation aim regarding Firtst manoeuvre compared to a percentage of the Reference Value sibelmed SIBELMED W 20 User s Manual 41 Rest of manoeuvres compared to a percentage of the patient s best one To be selected the Sound Warning if the aim is reached e Language Available among several SOFTWARE LINKS Select the LINKS option inside the SETUP menu Sa x Transducer SPIROMETER DISK Equipment 2120 D110 Channel seriar Channel Serial Port com Speed 19
26. can e Alter the pulseoximetry configuration e Hide show the data window e Initialize the statistical parameters of the data window e Consult Modify the test data e Store the parameters e Obtain 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 A SPECIFIC TESTS In the specific pulseoxymetry tests the screen will indicate the SpO and PR values according to the configurated 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 DURATION TESTS In long duration 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 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 interpretes that all the fragments belong to the same patient and the calculation of parameters will be made with the whole memory ANNEX 1 Pulse oximetry test Sibelmed SIBELMED W 20 User s Manual 146 If you want to perform the test with other patient change the patient s data entering the menu option or pressing the corresponding key 1 5 1 SOFTWARE SIBH
27. performance of this kind of test as his collaboration is essential for its correct execution 3 The maximum time to perform the manoeuvre is 15 seconds The device stores a maximum of eight manoeuvres 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 sibelmed SIBELMED W 20 User s Manual 5 The report with the parameters ans graphics is displayed next LUNG FUNCTION REPORT Reference 1111111111 Date 28 12 2005 Time 11 07 Name Lopez Garcia Francisco Sex 35 Height 180 Wgt Kg 75 Temp C 25 Pres mmHg 760 Humidity 65 JSmok I Motive BMI 23 1 Procedence Technician Transducer Disk References SEPAR Ethnic F 100 Version 51176FA 3 0 MVV REPORT Manoeuvre Nol SIBELMED W 20 OBS REF MVV l min 144 01 175 70 82 Br Min 44 36 T 1e3deu5 pue asn Jo suoinajsug UOI Sibelmed SIBELMED W 20 User s Manual 84 BRONCHODILATION TESTS The Spirometry Software SIBELMED W 20 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 bronchodilater susbtance in ord
28. resultant bronchoconstriction Up to two steps can be made in this mode ANNEX 3 Bronchoconstriction or bronchial provocation test Sibelmed SIBELMED W 20 User s Manual 174 INPUT OF TEST DATA The procedure for the input of the patient and environmental parameters is the same as the one described in the INPUT OF 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 Bronchoconstriction xj Normal Mode Short Mode Use Diluent Time between Constrictions min Time between Dilations fis Initial Dose mg ml 5 BC Substance Metacolina BD Substance Salbutamol Q 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 bronchoconstrictor medicine and the start of the manoeuvres e Define the time between the application of bronchodilator medicine and the start of the manoeuvres Sibelmed SIBELMED W 20 User s Manual 175 e Enter the initial dose of the bronchoconstrictor medicine in 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 graphs window al
29. 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 Sibelmed SIBELMED W 20 User s Manual 103 properly the device will detect it as incorrect manoeuvres 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 espiratory 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 assign 0 to the Calibration Volume I 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 CALIBRATION RECORD The spirometer has a record with the espiratory and inspiratory factors of the last thirty performed calibrations This is useful for those centres which require a quality control in the processes they use Click on the key Base in the initial screen of the calibration process
30. these softwares 2 Adobe Reader only allows to open PDF files not to print them out 6 If you have installed CutePDF you must also install the application Ghostscript SIBELMED W 20 User s Manual 15 Worl 7 If there is any database with a previous format in the folder c sibel W20 bdsibel it will be updated automatically leaving a copy of the old one into c sibel W20 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 OPTIONAL MODULES ACTIVATION In case you have acquired one or more optional modules of the W20 software Bronchoconstriction SpO2 o epMip you will have to introduce thecorrect 15 digit key supplied in order to activate them Main Menu SETUP Utilities Options Activation In case you have acquired the options but do not have the key available please consult our after sales department 5 pue ASN Jo 5 T 1e3deu sibelmed SIBELMED W 20 User s Manual BLUETOOTH MODULE INSTALLATION The standard steps to follow are described below A Bluetooth module needs to be installed on the PC for Bluetooth compatible spirometers 5 The Bluetooth interface allows data to transfer to the computer both for performing real time testing and for transferring tests saved the interna
31. this option the device is ready to start the spirometric manoeuvre Manoeuvres Data DATA Icon Allows to e Display the available information of the performed manoeuvres e Store a manoeuvre in the Data Base or for a Bronchodilation e Delete a manoeuvre e Get a manoeuvre printed report e Present the diagnosis Test Data Without icon accessible by options Allows to display some patient data environmental or other data related to the test being performed Graphics SEL Icon Allows to present on screen any of the graphics corresponding to the performed manoeuvres as well as superimpose some of them The asterisks indicate the position taken by the last manoeuvre Report Printer Icon Allows to make a report corresponding to the selected manoeure in the screen of Manoeuvre 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 1l in the graphic F V and 1l is equal to 25 in the graphic V T and only in FVC mode Zoom and Icons lens and lens SIBELMED W 20 User s Manual Enlarges or reduces the graphic maintaining the relations previously indicated Organise Windows Without icon accessible by options This option allows the user to organize the different selected windows proportionatelly The user can adjust the sizes manually by using the mouse and moving any side or edge of a w
32. 0 User s Manual 34 MAIN MENU This screen presents the main options available in the Spirometry Software SIBELMED W 20 with the corresponding suboptions n sar wart 101 9 20 Base de Bankes alni xj ront SETUP Printer Selection Parameters and Others Spirometry Maximum Pressure Pulseximetry Header Report Graphics and Others Links Check Device Utilities Activation Code Software purchase Update Bios SIBELMED W 20 User s Manual Update Flash Download data of the device About Exit 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 PulseOximetry SpO2 Icon HELP About Helps About the Software About Main Menu Visit SIBEL web page By entering each of this options the corresponding information is available Next a description of each function available with the SIBELMED W 20 is made 5 pue ASN JO 5 T 1e3deu sibelmed SIBELMED W 20 User s Manual SOFTWARE CONFIGURATION The Spirometry Software SIBELMED W 20 is a versatile program with multiple possibilities of functioning Some of them could be of no use for certain users So once the Installation and Cofiguration process ha
33. 03 ISO 9001 2008 EN 62304 2006 AC 2008 EN 62366 2008 EN 1041 2008 EN 980 2008 EN ISO 14971 2009 e European Medical Device Directive 93 42 CEE Class Ila USEFUL LIFE e 7 years S be med W 20 User s Manual suome yi2eds z Chapter 2 Technical Specifications SIBELMED W 20 User s Manual 130 Sibelmed SIBELMED W 20 User s Manual 3 MAINTENANCE 4 Sibelmed SIBELMED W 20 User s Manual 132 The Spirometry Software SIBELMED W 20 does not require any specific maintenance except that for any computer program handling information e Make a copy in a floppy disk 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 device it is recommended to follow these steps 1 Use the helps available in the program 2 Use this User Manual poperly 3 Contact with the After Sales Service of SIBEL S A at SIBEL S A Rossell 500 08026 BARCELONA SPAIN AFTER SALES SERVICE Tel 34 93 433 54 50 FAX T34 93 436 16 11 e mail sat sibelmed es S be med W 20 User s Manual 5 1o13deu 5 Chapter 3 Maintenance SIBELMED W 20 User s
34. 1 introduce the CD ROM in the CD ROM reading unit 2 If the PC s CD ROM unit has the auto run option active it will proceed to the automatic installation otherwise the program Setup exe should be executed after acceding to the corresponding ROM unit 3 The next options can be chosen when the following window appears sibelmed SIBELMED W 20 User s Manual Sibe med gt cou B Repair It reinstalls the program If there is a damaged or lost file it will repair it Start Menu Programs SIBEL Operating System Windows 98 Windows 2000 Windows XP or Windows Vista 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 check the computer s Operatimg System User Manual pue asn Jo SUOIJINAJSUT 1 34 Chapter 1 Instructions of use and instalation Sibelmed SIBELMED W 20 User s Manual INSTALATION AND PC MINIMUM REQUIREMENTS PC computer installation must be carried out acording to its user manual The computer must fulfill the folowing minumum requirements Hard disk 1Gbyte 20 Gbyte or more Graphic card 800 600 800 600 or more Monitor 15 17 Port RS232 USB 2 0 Other characteristics Operating system Windows 98 Windows 2000 Windows XP Windows Vista and Windows 7 Backup unit Recomended I
35. 200 9500 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 spirometer can be used with different transducers m 2 2n42SUT T suo IO JO 2150 pue 5 jsui pue esn 121 21 Sibelmed SIBELMED W 20 User s Manual 42 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 blow air in the transducer or for the software operation verification e The Device being used It allows selecting the spirometer model that is connected to the computer e The Channel for the communication between the spirometer and the computer It can be a serial port or an USB port e The Serial Port which will be used if this channel has ben selected Firstly verify how many serial ports the computer has and which ones of them are free Generally the mouse is connected to the COM1 port and consequently the Serial Channel goes into the COM2 Port e The Velocity of Transmission of the signal which must be the same that is
36. 28 MAINTENANCE 131 ANNEX 1 PULSE OXIMETRY 5 135 136 PULSE OXIMETRY 137 PULSEOXIMETRY CONFIGURATION 139 PROCEDURE FOR THE PULSE OXIMETRY TEST 141 Index sibelmed SIBELMED W 20 User s Manual 6 PERFORMANCE OF PULSE OXIMETRY TESTS 142 ENTERING PATIENT AND TEST DATA SIMILAR 142 PERFORMANCE OF PULSE OXIMETRY 143 PRINTING AND OR MEMORISATION IN THE DATA IgE 147 ANNEX 2 MAXIMAL PRESSURES TEST 151 152 MAXIMAL PRESSURES 153 MAXIMAL PRESSURES 155 PROCEDURE FOR THE MAXIMAL PRESSURE TEST 157 ENTERING PATIENT AND TEST DATA 157 PERFORMANCE OF MAXIMAL PRESSSURE TESTS 158 TEST 161 WINDOWS DESCRIPTION SELECTION AND DELETION MEMORIES erit
37. 7 0327 021009 234022945 1340 2085 17 01 2086 The window Patient Maneouvres 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 Patients Maneouvres 5 pue ASN JO suoijonJjsug T 1e3deu Chapter 1 Instructions of use and instalation Sibelmed 7 SIBELMED W 20 User s Manual 90 ORGANIZATION OF THE WINDOWS You can remodel the windows by pulling its edge with the cursor following pictures Vertical Mosaic Horizontal Mosaic Cascade SIBELMED W 20 User s Manual 91 g I 60477472274 Sades Uen x mimn Ferme de 4144144440 i Perea Hames Lorun Pede amt des E 58 28 Maris gt P iit H MAMMA 59 nn NOTE If you enter the export module from the patient card in the data base the program will only present the window Patient Manoeuvres 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 in the PATIENT CSV and the pressure graphics points associated to the tests are stored in the files GRAF001 CSV GRAFOO2 CSV The destination directory and the name of the file where the tests are stored can be changed entering
38. 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 Ascreen where you will be able to read Insert the disc came with your device name will appear select I don t have the disc Show me other options 5 Now a screen will appear that allows you to select between two options select Browse my computer for driver software 6 if your operating system is a Windows Vista 32 bits version select the directory D Driver W2K_WXP_WVISTAx32 of the spirometry CD For Windows Vista 64 bits select the directory D Driver WVistax64 Press OK 7 Click on Next and Finish The Driver will now install itself apter Sibelmed SIBELMED W 20 User s Manual SETUP Start the PC and run the program Press once over the icon W 20 found inside the folder of the Start Menu Programs SIBEL Operating System Windows 98 Windows 2000 Windows XP or Windows Vista 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 check the computer s Operating System User Manual Press OK on the screen ABOUT to enter the MAIN MENU Connect the spirometer to the computer SPIROMETRY SOFTWARE UNINSTALLATION
39. D W 20 User s Manual 28 USB INSTALLATION DRIVER For USB compatible spirometers a driver needs to be installed on the computer To install the Driver follow these steps 1 Start up the spirometer Consult the corresponding manual for use 2 Insert the W20 Installation CD into the computer Windows 98 2000 XP 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 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 D13Test in the directory D Driver W98 of the spirometry CD For others operating systems Windows 2000 Windows XP select the file Sibelusb of the directory D Driver W2K_WxXP Press OK 7 Click on Next and Finish The Driver will now install itself sibelmed SIBELMED W 20 User s Manual 29 Windows Vista 3 Connect the spirometer to the computer with the USB cable
40. E FOR PERFORMING THE CALIBRATION OF 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 in the spirometer calibration factors For this reason a calibration system has been integrated using a signal of reference volume for example a syringe Sibelmed SIBELMED W 20 User s Manual 98 Besides this calibraton factor the changes in volume associated to weather conditions temperature relative humidity and pressure must be taken into account 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 TRANSDUCER TYPES The DATOSPIR 600 can work with three different transducer types Neumotachometer Fleisch type Turbine Transducer type Disposable Transducer type The Neumotachometer Fleisch type is the system of flow measurement with the highest acknowledgment in the pneumologic field due
41. HOCONSTRICTION OR BRONCHIAL PROVOCATION TEST TEST DESCRIPTION For the performance of the bronchoconstriction or bronchial provocation test is recommended to those people who are not familiarised 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 Neumologia y Cirugia Toracica 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 manoeuvres and the best manoeuvre 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 Consists of applying to the patient a certain concentration for a specified time e Abbreviated method Consists of applying to the patient a certain number of inhalations of a certain concentration Sibelmed SIBELMED W 20 Us
42. Hg 760 Humedad Motivo Procedencia T cnico Referencias SEPAR F Etnico 100 INFORME DE FUNCION PULMONAR SIBELMED W 20 PARAMETRO OBS REF Mejor FVC 1 3 77 4 58 82 Mejor FEV1 1 3 15 3 59 88 FVC 1 3 77 4 58 82 FEVO 5 1 2 59 FEV1 1 3 15 3 59 88 FEV3 1 3 60 FEVO 5 FVC 68 69 FEV1 FVC 8 83 43 78 35 106 FEV3 FVC 100 00 FEV1 VC 84 62 PEF 1 5 7 45 9 03 83 MEF25 1 8 1 37 1 64 83 MEF50 1 5 4 85 4 62 105 MEF75 1 5 7 07 FEF25 75 1 8 3 69 3 67 100 FEF75 85 1 s 0 81 FET25 75 s 0 51 FET100 s 6 95 MEF50 MIF50 1 06 0 66 161 MTT s 0 86 FEV1 FEVO 5 1 21 1 45 84 FEV1 PEF 3 7 04 6 64 106 50 1 5 4 56 FIVC 1 3 73 1 3 70 FIV1 FIVC 99 19 FEV1 FIV1 0 85 0 80 106 PIF 1 5 4 90 PEF PIF 1 52 1 39 110 Vext 2 35 MVV Ind l min 94 42 1 3 72 1 0 78 1 0 98 IRV 1 1 96 Ic 1 2 74 Ti s 1 73 Te s 2 31 Tt s 4 04 Taf 3 42 84 MVV 1 min 150 83 151 82 99 Br Min 44 12 Diagn stico Diagn stico de Miller Alteraci n ventilatoria de tipo Restrictivo 165 Peso Kg 70 T S 5 C 9 3 m E 3 Chapter 1 Instructions of use and instalation 27 07 2000 Hora 18 48 Fecha 12470 Referencia l min f s 11 12 13 14 1 10 Chapter 1 Instructions of use and instalation Ssibelmed SIBELMED W 20 User s Manual 78 VISTA PRELIMINARY VIEW This opt
43. Manual 134 Sibel med SIBELMED W 20 User s Manual 135 ANNEX 1 PULSE OXIMETRY TEST OPTIONAL MODULE 15291 as nd T XANNV ANNEX 1 Pulse oximetry test Sibelmed SIBELMED W 20 User s Manual 136 INTRODUCTION With the Pulseoximetry option the spirometer can perform specific measurements of the Oxygen Saturation SpO and the Pulse Rate PR or long duration studies especially aimed at the control of patients during sleep or in any other situation saturation measurement etc The spirometer calculates statistical parameters for the reading of SpO and of PR as well as the desaturation Index per hour IDH4 IDH3 and IDH2 the percentage of desaturations under some value 90 CT80 and 70 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 Sibelmed SIBELMED W 20 User s Manual 137 PULSE OXIMETRY PROGRAM Next the different options of the Pulseoximetry 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 Alarm limits Acoustic signals Average e Start of the manoeuvre e Data of the manoeuvre e Initialize the data e Test Data e Change of patient e Store
44. O 30 100 and PR 20 250 BPM e Activation Deactivation of the acoustic signals e Average of SpO 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 sonar If the alarm signal is activated and the maximum and minimum limits of SpO or PR are surpassed an alarm signal at regular intervals will be heard While the alarm lasts the beep in the pulse will be automatically deactivated The averaging of SpO2 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 more 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 Sibelmed SIBELMED W 20 User s Manual 141 PROCEDURE FOR THE PULSE OXIMETRY TEST As it has been said before it is possible to make single measures and long duration studies 8 hours aproximately 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 1591 T ANNEX 1 Pulse oximetry test Sibelmed
45. RT SIBELMED W 20 PARAMETER OBS IDH 4 IDH 3 IDH 2 5 02 5 02 Avg 5 02 SpO2 Std PR Max PR Avg PR Min PR Std T Study 2 00 32 B MEMORISATION IN THE INTERNAL DATA BASE At any moment you can enter the option Store Test from the pulseoximetry tests screen fisPIROMETRY SOFTWARE SIBELMED W 20 SOFTWARE SIBELMED W 20 Data Base Setup Options Help Setup Options Help C Start Maneouvre Test data Reset data Test Data Change Patient Report Organise windows Sibelmed SIBELMED W 20 User s Manual 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 ATTENTIONS x No Manoeuvres If the calculated parameters for the study have been stored correctly this message will be displayed 15291 os nd T XANNW ANNEX 1 Pulse oximetry test SIBELMED W 20 User s Manual 150 Sibel med SIBELMED W 20 User s Manual 151 MEN ANNEX 2 MAXIMAL PRESSURES TEST OPTIONAL MODULE 1591 sainssaid z XANNV ANNEX 2 Maximal pressures test Sibelmed SIBELMED W 20 User s Manual 152 INTRODUCTION The maximal pressure module has been designed in collaboration with the Laboratory of Pulmonary Function of the Hospital de S
46. SALES SERVICE Tel 34 93 433 5450 FAX 34 93 436 16 11 e mail sat sibelmed es 5 pue ASN JO 5 T 1e3deu 112 Sibe med SIBELMED W 20 User s Manual pue asn Jo SUOI INAJSUT Sibe lmed SIBELMED W 20 User s Manual 113 2 TECHNICAL SPECIFICATIONS suome yi2eds jediuysal z 193deu 5 Chapter 2 Technical Specifications Sibelmed SIBELMED W 20 User s Manual SOFTWARE COMPATIBILITY e Windows 98 SE e Windows 2000 SP 4 e Windows XP SP 1 or SP 2 e Windows Vista 32 or 64 bits e Windows 7 114 Sibelmed SIBELMED W 20 User s Manual 115 TYPES OF TESTS FUNCTIONS AND SPIROMETRIC PARAMETERS FORCED VITAL CAPACITY FVC Parameters FVC FEV 5 FEV1 FEV3 FEV 5 FVC FEV1 FVC FEV3 FVC FEV1 VC PEF FEF25 FEF50 FEF75 FEF25 75 FEF75 85 FET25 75 FET100 FEF50 FIF50 FEV1 FEV 5 FEV1 PEF FIF50 FIVC FIV1 FIV1 FIVC FEV1 FIV1 PIF MTT PEF PIF Vext 1 1 1 1 5 1 5 1 6 1 6 1 6 1 6 5 5 Vs 1 1 5 s Forced Vital Capacity Forced Espiratory Volume in 0 5 seconds Idem in 1 second Idem in 3 seconds Relation Relation Relation Relation Peak Espiratory Flow Instantaneous forced expiratory flow when 25 has been expired Idem at 50 Idem at 75 Forced Mesoespiratory Flow Medi
47. SETUP SPIROMETRY SOFTWARE INSTALLATION WARNING If the software is going to be installed under Windows NT 4 Windows 2000 Windows XP or Windows Vista systems the user must have Administrator rights to be able to install all the program s features In case of any doubts contact your Sytem Administrator or check the help of the Operating System For the Software installation in the PC hard disk proceed as follows 1 Introduce the CD_ROM in the CD ROM reading unit 2 If the PC s CD ROM unit has the auto run option active it will proceed 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 Choose Setup Language Ihe longuage for the metallobor From the choices 4 Please choose the directory where to install the program and the group of programs name The program s default installation directory is SIBEL W20 Chapter 1 Instructions of use and instalation sibelmed SIBELMED W 20 User s Manual SPIRO TRY SOFTWARE SIINTMED WAS Welcome tn the uf SOFTWARE 0978 Sibelmed 5 Please install the CutePDF and Ghostscrip software to print out the report in a PDF file Notes 1 If you have any other application to print out in PDF it is not necessary to install
48. SIBELMED W 20 SPIROMETRY SOFTWARE USER S MANUAL Sibelmed 511 8FO MU2 e REV 2 01 2012 04 SIBEL S A Rossell 500 08026 Barcelona Ventas Nacionales Tel 93 436 00 08 e mail comercial sibelmed com Ventas Internacionales International Sales Tel 34 93 436 00 07 e mail export sibelmed com Servicio t cnico Technical serv Tel 34 93 433 54 50 e mail sat sibelmed com Fax 34 93 436 16 11 Web www sibelmed com Sibelmed SIBELMED W 20 User s Manual 3 INDEX DECLARATION OF 7 1 INSTRUCTIONS OF USE AND 9 nua una 10 PREVIEW 11 RESPONSABILITY OF THE MANUFACTURER 12 INSTALLATION AND SETUP 13 SPIROMETRY SOFTWARE 13 OPTIONAL MODULES ACTIVATION 15 BLUETOOTH MODULE 16 USB INSTALLATION DRIVER eee 28 SETUP EENAA 30 SPIROMETRY SOFTWARE UNINSTALLATION 30 INSTALLATION AND COMPUTER REQUIREMENTS 32 INSTALLATION AND PRINTER 33 ABOUT ONSCREEN HELP nennen nennen nnn 33 MAIN MENU
49. SIBELMED W 20 User s Manual 142 PERFORMANCE OF PULSE OXIMETRY TESTS To enter the Pulseoximetry press over the Pulseoximetry icon from the main menu INPUT OF PATIENT AND TEST DATA If the patient and test data have been previously entered the program will directly go to the Pulseoximetry 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 SSS Mea ca 369 weighs ve suni Normal weight motive a Provedense Technician Sibelmed SIBELMED W 20 User s Manual The input of smoker index weather data ethnic factor and references are deactivated when they are not used in the Pulseoximetry test PERFORMANCE OF PULSE OXIMETRY TESTS After having validated the test data with the key OK the performance tests screen will be shown The screen shows the message in green READY Press the key START to begin the study The pulseoximeter 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 eS PT ee Pe HSE C 00 000 1
50. Setup Options Help Setup Options Help C Start Maneouvre Test data c Reset data m Test Data Save test Report Organise windows If the thimble probe is disconnected the signals of SpO 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 Sibelmed SIBELMED W 20 User s Manual PRINTING AND OR MEMORISATION IN THE DATA BASE A PRINTING OF THE RESULTS At any moment you can enter the option report from the pulseoximetry tests screen Setup Options Help Opes Hep Start Maneouvre ch c Test data Reset data Pulsio Test Data Change Patient Save test 8 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 No Manoeuvres Otherwise the following report will be printed 15291 os nd T XANNW Pulse oximetry test ANNEX 1 SIBELMED W 20 User s Manual SIBEL S A Reference 1111111111 Date 28 12 2005 Time 10 59 Name Lopez Garcia Francisco Sex 35 Height cm 180 Wgt Kg 75 Temp C Pres mmHg 760 Humidity Smok I Motive BMI 23 1 Procedence Technician Transducer Disk References SEPAR Ethnic F Version 51176FA 3 0 PULSEOXIMETRY REPO
51. Software SIBELMED W 20 511 8FO MU2 1 User Manual WARNING According to the different standards it is advisable to verify and or calibrate the medical products periodically in order to warant 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 Chapter 1 Instructions of use and instalation SIBELMED W 20 User s Manual 12 RESPONSABILITY OF THE MANUFACTURER SIBEL S A is responsible for the safety fiability and functioning of this device only if e The computer where the software is installed meets the requirements related to electrical installation IEC UNE for medical devices as well as the other applicable norms 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 SIBELMED W 20 User s Manual INSTALLATION AND
52. User s Manual 106 x E d 9 Introduce the activation code that has been provided when acquiring this software From now on the Sibelmed W20 will be unblocked to be used freely without any problems 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 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 SIBELMED W 20 User s Manual 107 UPDATE OF THE DEVICE S SOFTWARE The DATOSPIR spirometers from SIBEL S A except for the D70 have an updating and software maintenance process resident inside themselves To update the version of the software follow these instructions D120 D110 Check the User Manual for the DATOSPIR 110 120 Spirometer D600 To update the version of the D600 internal software the option Setup Utilities Update Flas should be selected The next screen will appear femen m mw 5 pue ASN JO suoijonJjsug T 1e3deu Chapter 1 Instructions of use and instalation Ssibelmed SIBELMED W 20 User s Manual 108 Check that the device is ON and connected to the comput
53. ameters In order to fill in 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 ee ase ma e o0 p 203197 9 6 When performing spirometric test it is necessary to enter certain data related to the patient to the environment others that vary from one test to another Among them we point out e Date and 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 as a smoker Cigarettes day x years as a smoker 20 e Cigarr d Cigarrettes 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 and inctalatinnm use and instalation of structions ISt In hapter 1 1 Sibelmed SIBELMED W 20 User s Manual e Height in cm between 100 and 215 cm e Weight in Kg between 15 and 135 Kg e Temperature in the room in C between 10 and 40 9C e Pressure in mmHg between 430 and 779 mmHg e Humidity in the environment in 9o between 0 and 100 These 3 last values are taken automatically if the equipment has a meteorological station integrated There are other fields like e Motive or cause for performing this test
54. an 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 300 cmH O in inspiratory and espiratory tests It has several reference values available to be set up by the user Sibelmed SIBELMED W 20 User s Manual 153 MAXIMAL PRESSURES PROGRAM Next the options of the maximal pressure program are displayed 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 References Colours e Patient change e Start of manoeuvre e Change of PEmax and PImax or viceversa e Selection of manoeuvre e Delete the selected manoeuvre e Store in the data base e Report performance e Zoom Zoom and organise windows 1591 sounssoud 1 z XaNNV ANNEX 2 Maximal pressures test Sibelmed SIBELMED W 20 User s Manual 154 The operative windows enable the manoeuvre display and the whole test data These are the following e Window of the best 3 manoeuvres e Summary window of the test data e Window of manoeuvre in process e Window of memory display Sibelmed SIBELMED W 20 User s Manual MAXIMAL PRESSURES CONFIGURATION It is recommended for the user to set up the Maximal Pressure module according to their needs The Maximal Pressure configurati
55. aphy on this subject Sibelmed SIBELMED W 20 User s Manual 159 In the test performance follow these steps ri 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 manoeuvre Ensure also that the Obturer Probe is connected to the module 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 colour The obturer probe must be in open position in order to enable the patient to breathe normally OPEN 4 gt CLOSED CURSOR Once the patient has reached the position of Total Pulmonary Capacity move the cursor to the closed position and perform the manoeuvre ANNEX 2 Maximal pressures test Sibelmed SIBELMED W 20 User s Manual 160 4 Once the manoeuvre has finished repeat the step 3 to perform additional manoeuvres It is advisable a minimum of 3 manoeuvres The best 3 must not differ more than 5 among them and the last one must not be the best Sibelmed SIBELMED W 20 User s Manual TEST INFORMATION WINDOWS DESCRIPTION SELECTION AND DELETION OF MEMORIES For studying the evolution of the Maximal Pressure test the program has four windows Next these windows are displayed and
56. ck 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 SIBELMED W 20 User s Manual 51 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 PACK Check DATA BASES DATA BASE MAINTENANCE Warning If you are working with an old data base 2 07 version or previous deleting and packing operations are not all
57. ctly 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 x Dey Mirth Year Tina Datexemce Denes gt Mame t 75 verge ae Precedence Du 3 eem y Comment 3 2 0 15291 sainssaid 1 z XaNNV ANNEX 2 Maximal pressures test Sibelmed SIBELMED W 20 User s Manual 158 The 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 PERFORMANCE OF MAXIMAL PRESSSURE TESTS After the test data have been validated with the OK key the screen of tests performance is accessible 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 bibliogr
58. deletes the selected manoeuvre e The Summary key show the data of the performed steps e The Dose key saves the best manoeuvre and goes on to the next step This key is actually deactivated when entering the bronchodilation step e The Dilat key saves the best maneouvre and goes to the bronchodilation step This key is activated if at least the diluent step has been performed Press Dose to store the manoeuvre and go to the next one 1591 10 01321135 020 2 XANNV ANNEX 3 Bronchoconstriction or bronchial provocation test Sibelmed SIBELMED W 20 User s Manual 178 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 manoeuvres once the normalized time has elapsed e The manoeuvres are compared to the stored basal e The DATA icon gives you access to the display of the data After the adequate manoeuvres have been performed press the DATA icon to display the data and again Dose to store the best manoeuvre and go to the next step im xj Pets Accum Dove mg ml 9 BD Substance S albutamol B Sibelmed SIBELMED W 20 User s Manual 179 3rd Step CONSTRIC BC1 Modify the data if necessary Apply the first dose of bronchoconstrictor medicine and press OK Start a series of manoeuvres again SR TO
59. e 141 217 Manoeuvre 118 93 Average 118 93 ws 200 150 100 50 250 cm H20 99 1 2 3 4 5 6 7 8 Sibelmed SIBELMED W 20 User s Manual B MEMORISATION IN THE INTERNAL DATA BASE The following window will appear where you can choose the PImax and PEmax curves to store in the data base The results of all the manoeuvres will be stored indifferently of the selected curves fi sPiROMETRY SOFTWARE SIBELMED W TESPIROMETRY SOFTWARE SIBELME Setup Options Maneouvres Help Setup Options Maneouvres Help 5 Start Maneouvre Test Data Change Patient Best r Change to Pim Report 250 P Zoom Zoom Organise windows 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 pue 203 M2 m 233 M3 1 219 4 M5 Save the test i Test stored MaxIP 2 MaxEP 1 1591 sounssoud 1 z XaNNV ANNEX 2 Maximal pressures test SIBELMED W 20 User s Manual 170 Sibe med SIBELMED W 20 User s Manual 171 gt BRONCHOCONSTRICTION OR BRONCHIAL PROVOCATION TEST 1591 ery2uoJ4q uoi 2113suo20u2u04g sibelmed SIBELMED W 20 User s Manual 172 PROCEDURE FOR THE BRONC
60. e from 375 to 780 mmHg 5 mmHg e Humidity from 0 to 100 5 123 suome yi2eds 7 Chapter 2 Technical Specifications Sibelmed SIBELMED W 20 User s Manual 124 MAXIMAL PRESSURES MODULE PARAMETERS Both in the espiratory and the inspiratory tests it is measured e Maximum Pressure of the 5 manoeuvres e Mean of the best 3 e Standard Deviation of the best 3 RANGES AND MEASUREMENTS e Measurement Rang cmH20 300 to 300 e Resolution cmH20 1 e Precision 3 Sampling Frequency Hz 100 Manoeuvres under 10 cmH20 are dismissed CONTROL e Number of manoeuvres A maximum of 5 manoeuvres of each type can be performed PEmax and PImax e Manoeuvre Duration The maximum duration is 8 seconds Sibelmed SIBELMED W 20 User s Manual 125 e Manoeuvre Start When it gets beyond the 3 cmH20 threshold e Manoeuvre Ending Less than a 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 basefor all the different tests suomneoyi2eds S stion ation Jecificati PLA SIBELMED W 20 User s Manual 126 PULSE OXIMETRY MODULE TESTS AND PARAMETERS The spirometers allows performing lone measurements or long duration ones For both lone studies or long duration studies the next parameters can be ca
61. edence Technician References Version 1111111111 Date Lopez Garcia Fra Man 35 25 Pres mmHg 760 SEPAR Ethnic F 51176FA 3 0 28 12 2005 Time 11 10 Height cm 180 Wgt Kg 75 Humidity 65 Smok I BMI 23 1 Transducer Disk 100 6 SIBELMED W 20 User s Manual 87 IMPORTING TESTS FROM THE SPIROMETER When activating the icon BATCH or the option Importing Tests of the Main Menu the following screen is presented Data Import Data D SIBEL 20 Bdsibel sibel E xj NO REFERENCES No Reference Typo Pl 2 Date Time 0001 1111111111 FVC 5 98 4 26 23 03 2005 10 25 00 0002 1111111111 FVC 5 46 3 89 23 03 2005 10 26 00 0003 1111111111 FVC 1 24 0 92 23 03 2005 10 27 00 0004 1111111111 VC 3 72 0 77 23 03 2005 10 27 00 0005 1111111111 VC 3 35 1 11 23 03 2005 10 28 00 OE m This option allows to transfer or import tests which are stored in the spirometer DATOSPIR 70 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 on In the DATOSPIR 70 case it has to be in ON LINE mode 3 Select the tests to be transferred with the mouse if they are 4 Press the key IMPORT to transfer 1 4 2n SUT UOI S sn ue pL
62. ent 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 Sibelmed SIBELMED W 20 User s Manual 181 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 administratio x Partial Accum Dose mg ml amp BD Substance Salbutamcl 2 63 Q e Enter the data for the bronchodilator medicine and press OK The chronometer will be enabled and will return to the tests screen e Apply the bronchodilator to the patient e After the normalized time perform a series of manoeuvres e Store the best manoeuvre and repeat the previous process if necessary 1591 10 01321135 020 2 ANNEX 3 Bronchoconstriction or bronchial provocation test Sibelmed SIBELMED W 20 User s Manual 182 SUMMARY PRINTING and or STORING OF THE TEST The summary of the bronchoconstriction is presented in graphic form graphic dose response previously shown or in numeric 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 Bronchoconstric
63. er 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 W20 Click the START button and verify the evolution of the loading process in the screen Finally a transmission completed message will appear 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 Sibelmed SIBELMED W 20 User s Manual 109 DOWNLOAD DATA OF THE DEVICE The spirometers DATOSPIR 110 120 and DATOSPIR MICRO have the option of transferring information to the computer This information is saved in internal files and contains data about e Hardware Checking e Software Checking e 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 AfterSales 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 follow the next steps 1 Turn on the device and select the option Autochecking Execute all the
64. er s Manual 173 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 medicine 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 seguir la prueba se pasa a la siguiente etapa 4th CONSTRIC BC2 The same as the last step but with the second dose of medicine 5th CONSTRIC BC3 The same as the previous step but with the third dose of medicine The process can be repeated until it is convenient The system allows to apply 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 bronchial provocation 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 to revert the
65. er to compare them The procedure to make the Postbronchodilater Spirometry Test is the following 1 Perform a FVC VC or MVV test according to the previous sections Store the best manoeuvre in PREbronchodilation mode as described in the Manoeuvre Data subsection of the FVC PROCEDURE section 2 Apply to the patient a dose of bronchodilater 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 manoeuvre in the disposable transducer case it also saves the Transducer Code and it is recovered in the POST manoeuvre SIBELMED W 20 User s Manual 85 Dees dob macte 5 Then proceed as described in ENTERING FORCED VITAL CAPACITY TESTS subsection of the FVC PROCEDURE section Dram emr rrea sanen o ra raene RR ei S s Lu inn 6 If the printed report is required the data are presented in a similar way to the displayed next 5 pue ASN JO 5 T 1e3deu mon talat 115 f use and i 1ons o Instructi Chapter 1 Sibelmed 7 SIBELMED W 20 User s Manual LUNG FUNCTION REPORT Reference Name Sex Temp C Motive Proc
66. ess 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 9 data Exporting tests The software allows for tests to be exported only if the user is 8 identified authorized to read the database Once the test has been exported to a file the software user is responsible for S the security of said file and its later deletion 5 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 unauthorised access 193 Sibel med SIBELMED W 20 User s Manual ANNEX 4 Compliance with the data protection act directive 95 46 EC 194 Sibel med SIBELMED W 20 User s Manual 23 9r S6 gt uoij2o304d ay p XaNNV Sibel med SIBELMED W 20 User s Manual 195 urm ibe T Some prm bres E ie en Ral ANNEX 5 MODIFICATIONS SUO IJEIYIPOW lt XANNV ANNEX 5 Modifications SIBELMED W 20 User s Manual 196
67. hods between PRE and POST 9o Average between PRE and POST 9o between REF and POST 9o between PRE and POST Difference between PRE and POST Sibelmed SIBELMED W 20 User s Manual 119 Graphics Superimposition PRE and POST in the external printer BRONCHOCONSTRICTION TEST Parameters e FVC 1 Forced Vital Capacity e FEV1 1 Idem in 1 second e PEF 1 5 Peak Espiratory Flow e FEF25 75 1 5 Forced Mesoespiratory Flow e All the FVC test parameters can be selected Patient Identification Data Environmental Data temperatura 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 drug 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 Chapter 2 Technical Specifications Sibelmed SIBELMED W 20 User s Manual 120 PROGRAM CONFIGURATION Software setup by the user in the following aspects e Type of printer e Parameters diagnosis references and others e Graphics pediatric motivation and language e Data Bases e Communication Links with the software 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 graph
68. how to interpret its information is commented A Window of manoeuvre in progress It represents the variation of pressure as the manoeuvre is taking place This window emerges by pressing the START key and disappears by finishing the manoeuvre when the Start key is pressed by waiting for 8 seconds or when a pressure lower than 1 cm H O during 2 seconds exists The horizontal line of dots indicates the reference value Once the manoeuvre is finished the position for the maximal pressure and its value are calculated The next message 15291 sainssaid 1 z XaNNV ANNEX 2 Maximal pressures test Sibelmed SIBELMED W 20 User s Manual shows if this value is higher than the maximal pressure of the previous manoeuvres West patum one B Window of the best three manoeuvres In this window the best 3 manoeuvres 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 espiratory pressure would be calculated M4 would be in the second place and M1 in the third place See the corresponding data window Summary or data window in the next page If the three manoeuvres 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 pre
69. ics e 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 Sibelmed SIBELMED W 20 User s Manual 121 MEASUREMENT SYSTEM e Transducer Turbine type Fleisch type or Disposable type depending on the spirometer e Measurement Scale Flow from 16 1 5 to 16 I s Volume from 0 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 suomneoyi2eds Chapter 2 Technical Specifications Sibelmed SIBELMED W 20 User s Manual 122 ANALYSIS CRITERIA e Strart espiration FVC By the retrograde extrapolation method e Final espiration FVC When the accumulated volume in the last second is lower than 0 03 litres e Selection of tests FVC According to the criteria of maximum addition of FVC FEV1 or at the operator convenience e Selection of parameters and FEV1 of the highest value among the stored tests For the rest of parameters in the selected test the one with the highest addition is recommended e Start of espiration in VC and MVV by signal level e Selection of tests and parameters in VC and MVV Highest value in VC or MVV Sibelmed SIBELMED W 20 User s Manual ELECTRONIC WEATHER STATION e Temperature from 0 to 50 C 1 C e Pressur
70. indow 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 Organise Windows Moreover there is an icon available to visualize a preliminary view of the report SUMMARY OF THE MANOEUVRES DATA Forced Vital Capacity Mode Presents the parameters FVC FEV1 PEF and FEF25 75 of the eight best performed manoeuvres M1 M8 as well as the best values according to ATS criteria green color the Reference value and of the best values according to the Reference value In POSTbronchodilation mode the Reference values are changed by the ones obtained in PREbronchodilation mode The manoeuvres are ordered from best M1 to worst M8 according to the ATS criteria of the maximum addition of FVC FEV1 and according to the detected errors in each manoeuvre The labels M1 M8 indicate the colour for the associated graphic The square brackets e g M3 indicate the position taken by the last performed manoeuvre Slow Vital Capacity Mode The same with the parameters VC VT and ERV Maximum Voluntary Ventilation Mode The same with the parameters MVV and Br min Sibelmed SIBELMED W 20 User s Manual 66 GRAPHICS Presents the graphic windows selected in GRAPHICS AND OTHERS 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
71. ing of unauthorised accesses The next stop is to activate the audit of access to objects in 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 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 W20 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 Sibelmed SIBELMED W 20 User s Manual 190 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 W20 and from now on lt W20_HOME gt Bdsibel This file is created the first time that the application is executed and is not deactivable 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 analysed and any problems detected are reported should there be any The log file is saved by line e User Time and date of access e Database accessed e Action carried out on the database e Type of access authorised or denied e File path of database accessed e Reference of the regis
72. ing system in order to comply with the requirements of said law is described IMPORTANT WARNING e According to current legislation the software user is solely responsible for the storage and treatment of their patient data in accordance with the law e 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 W20 Spirometry Software Identification and Authentication The processes for user identification and authentication for use of the SOFTWARE W20 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 and Windows Vista with an NTFS file structure Windows 9x systems or FAT file structures are not valid Sibelmed SIBELMED W 20 User s Manual 187 The PC administrator must create a unique and personalised identification for each user and activate authorisation 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 unauthorised access Consult the manual for the operating s
73. ion shows a preliminary view of the report to be able to check its format before printing it This window has the next icons 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 sibelmed SIBELMED W 20 User s Manual 79 PROCEDURE FOR SLOW VITAL CAPACITY VC m The procedure to performe the slow Vital Capacity test is similar to the one described in the PROCEDURE FOR FORCED VITAL CAPACITY FVC 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 manoeuvres 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 manoeuvre is 60 seconds The device stores a maximum of eight ordered manoeuvres according to VC value and being M1 the one of highest VC and M8 the one of lowest 4 In order to measure the parameters ERV and TV correctly each manoeuvre must have at least four respiratory cycles 5 The graphic is displayed in Volume Time mode and the motivation graphic is not available 2 SUT T SUT 2
74. k on install A warning message may appear during the software installation informing you that no Bluetooth device has been detected HR arre A 2 Y HEC i ee ana ee n es um epee bns LIN LL EX xL ___ Fa a ta Do not connect the device Click on cancel to finish installing all of the software uomejejsui pue esn Jo T 4o3deu 5 Chapter 1 Instructions of use and instalation SIBELMED W 20 User s Manual Once the installation has finished click on finish a ia oca uni rnm __ ries MN a Sarr Pp ee ye __ Rumi H Temm Ped as db um me _ el ae as m g eee FE L ML LE LE lI IEEE Pla ade Barre ee Beil gd The icon for the Bluetooth device will then appear on the bar at the bottom right hand side Places SIBELMED W 20 User s Manual 21 2 Bluetooth Device Connection Once the software has been installed you can connect the device ee ee ees ee and it will then acknowledge the device 5 pue ASN JO SUOI JINAYSUT T 1e3deu Chapter 1 Instructions of use and instalation sibelmed SIBELMED W 20 User s Manual and lastly it will ask you to ins
75. l spirometer database u The Bluetooth chip installed in the spirometer uses the Bluetooth Series Port service or profile known as SPP Therefore and a as you will see in the following sections this will be the profile that must be installed in the computer to allow communications with the equipment WARNING 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 SIBELMED W 20 User s Manual 17 Follow the manufacturer s instructions at all times 1 Software installation The software installation must be carried out before connecting the Bluetooth device _ s Se oe r Ta ad oH ae c 9 T pr ae hid Saree grme a To do so insert the Bluetooth module CD that was provided by the manufacturer into the computer 5 pue ASN JO 5 T 1e3deu Chapter 1 Instructions of use and instalation SIBELMED W 20 User s Manual ee aco nb ee ____ _ ee __ gt o B a pcr L _ T LAM Er __ b ee ee ee sibelmed SIBELMED W 20 User s Manual 19 Select the directory where you wish the software to be installed and then clic
76. l the patients and tests subwindows get positioned in a tiled 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 SIBELMED W 20 User s Manual 55 It updates the 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 accedes 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 WARNING If you are working with an old data base 2 07 version or previous a new message warning about it will appear when entering the exploration window and that will allow you to convert it to a new data base format If it gets converted successfully it will keep containing the same information and any operation will be able to be performed on it Otherwise deleting and packing operations are not going to be allowed on it and it will keep showing the same message when entering the exploration window sibelmed SIBELMED W 20 User s Manual 56 DATA BASE MAINTENANCE
77. lculated 90 CT70 IDH 4 IDH 3 IDH 2 SpO2 Max SpO2 Medium SpO2 Min SpO2 Std PR Max PR Medium PR Minimum PR Std of the time in which the SpO2 is under 9096 of the time in which the SpO2 is under 80 of the time in which the SpO2 is under 70 index of dessaturations gt 4 per hour index of dessaturations gt 3 per hour index of dessaturations gt 2 per hour maximum value of the Saturation medium value of the Saturation m nimum value of the Saturation standard deviation of the Saturation maximum value of the pulse rate medium value of the pulse rate m nimum value of the pulse rate standard deviation of the pulse rate Sibelmed SIBELMED W 20 User s Manual 127 e Test Time time of use of the test the finger probe unplugged time is not count RANGES AND MEASUREMENTS SpO2 9 7 Pulse BPM Measurement Range 0 100 0 250 Resolution 1 1 Precision 70 to 100 2 2 or 2 the largest of both 60 to 70 lt 60 Unspecificied CONTROL e Start and ending of the manoeuvre suitable to the user e One only valid study until the change of patient e When initializing the data the program allows starting a new study for the same patient suomneoyi2eds Chapter 2 Technical Specifications Sibelmed SIBELMED W 20 User s Manual 128 GENERAL DATA e Applicable Norms Spirometry ATS ERS SEPAR EN 13485 2003 AC 20
78. n bold type to indicate that it will be used in certain actions specially to delete it through the menu option Manoeuvres Delete to store its curve in the data base and to represent its curve in the report Check Printing and or memorisation in the data base ANNEX 2 Maximal pressures test Sibelmed SIBELMED W 20 User s Manual By default the program automatically selects the best of the manoeuvres m To select a memory PImax different to the best 1 Make sure that the inspiratory procedure is activated through the icon Mip Mep or the menu option Options Change to PImax the axis of time in the window Best manoeuvre must be in the upper part 2 In the menu Manoeuvres Select click on the desired manoeuvre or in the window Summary click with the cursor over the manoeuvre to be selected within the area limited by the emphasized rectangle as indicated next Maneouvres Help maxlP EE THEM Memory EM 23 Delete Memory 2 oe e 233 El 2 0 Memory4 M5 BAe oe oe Sibelmed SIBELMED W 20 User s Manual To select a different memory Pemax perform also the step 2 previously making sure that the espiratory procedure is activated after step 1 To delete a manoeuvre first select it and then enter the menu option Manoeuvres Delete The following window will appear which will enable to confirm the deleting
79. n4 s suol IO JO esn pue 21SUI D 11 Chapter 1 Instructions of use and instalation Sibelmed SIBELMED W 20 User s Manual 80 Date Deve 6 The report with the parameters and graphics is displayed next sibelmed SIBELMED W 20 User s Manual LUNG FUNCTION REPORT Reference 1111111111 Date 28 12 2005 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 Disk References SEPAR Ethnic F 100 Version 51176FA 3 0 VC REPORT Manoeuvre Nol SIBELMED W 20 PARAMETER OBS REF vc 1 3 36 TV 1 1 11 ERV 1 0 73 IRV 1 1 53 IC 1 2 64 Ti s 1 70 Te s 2 68 Tt s 4 38 Ti Tt 38 80 T 1e3deu5 pue asn Jo suoimonajsug Chapter 1 Instructions of use and instalation Sibelmed SIBELMED W 20 User s Manual 82 PROCEDURE FOR MAXIMUM VOLUNTARY VENTILATION MVV The procedure to make the test of Maximum Voluntary Ventilation MVV is similar to the one described in the PROCEDURE FOR FORCED VITAL CAPACITY FVC section but with the following variations 1 if the test is performed to the same patient activate the icon MVV and start the series of spirometric manoeuvres If he is a new patient start as described in the ENTERING PATIENT AND ENVIRONMENTAL PARAMETERS section 2 Train the patient about the
80. nce 1 r 6 Status Day Montt Year Reference Birth Date zo 10 1270 35 Name Francisco Job Analista Surname Lopez Garcia ts Man Wome Address de maig 290 City Barcelona 000 Postal Code 08025 Country Espa a Telephone 34560008 Mobile 34360009 Comments E Patient Tests Par m Valor Ref 005 23 03 2005 10 006 23 03 2005 10 007 23 03 2005 10 008 01 12 2005 11 Sibelme d SIBELMED W 20 User s Manual 46 e NEW Enter a new patient e 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 to activate PRESENT DELETED RECORDS e CONSULT Search a patient card e TRENDS It shows a report of all the sellected test of the patient In this report it is possible to see the evolution of the next parameters FVC 1 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 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 li
81. nd file of destination and press Accept A bar will appear which will indicate you about the percentage of the performed export In the selected destination directory the files PRUEBAS CSV PATIENT CSV GRAF001 CSV GRAF002 CSV If these files were existent they will be deleted and replaced by the new ones including the exported tests Sibelmed SIBELMED W 20 User s Manual 93 EXPORT TESTS TO 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 Mail 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 addressee email and the desired information 4 Press Send to transmit de mail 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 spirometry software SIBELMED W 20 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
82. nes A N 74x 5 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 SIBELMED W 20 User s Manual 47 of tests of the patient card and press twice with the mouse left key The other way consists of choosing the test and press 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 e Surname e Nr of Record Next press CONSULT and 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 When pressing TRENDS the next screen appears 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 5 pue jo Suoina4gsu Sibelmed SIBELMED W 20 User s Manual 48 The following options are presented Setup This option allows to Setup the p
83. ng the export IMPORT CSV FORMAT TESTS 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 W 20 available For that after having made all the spirometric tests of maximal pressures and or pulseoximetry 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 file and directory A file called GRAFxxx CSV will be also stored usually GRAFOO1 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 Execute 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 SIBELMED W 20 User s Manual The following window appears 14111101111 wc 9 E Eoo It shows the tests stored in the file PRUEBAS CSV Click with the mouse over the tests to be imported to the data base of the spirometry software SIBELMED W 20 or click over the key S AII in order to select all the tests Click on the OK butt
84. of test e It presents the Observed and Reference values of the different parameters as well as the e It displays the selected record and the total number of records in the Data Base e It indicates that the record has been deleted if the status section is activated It is possible to explore the different tests of the same patient through the keys slow advance record by record or keys of fast advance each 10 records until the needed card is found 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 Sibelme d SIBELMED W 20 User s Manual 54 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 TILED Al
85. on The program will show the percentage of the import until it is done 5 pue ASN Jo 5 T 1e3deu sibelmed SIBELMED W 20 User s Manual 60 5 PROCEDURE FOR FORCED VITAL 5 CAPACITY FVC tala The procedures to be used for the spirometric test of Forced 5 Vital Capacity FVC Slow Vital Capacity VC and the 5 Maximum Voluntary Ventilation MVV as well as the 9 Postbronchodilation DILAT mode are very similar Only a detailed explanation will be made at this point n 3 ENTERING PATIENT AND ENVIRONMENTAL a PARAMETERS The Datospir 120 must have the menu Spirometry selected so the pneumotac heater can get warmed Select OPTIONS Spirometry in the Main Menu or activate directly the icon corresponding to the patient performing a spirometric manoeuvre the next screen appears C nerona T om 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 Base and the Reference or Surname if he is already existent In the first case after pressing OK the Patient Card appears which must be completed with the convenient data At least sibelmed SIBELMED W 20 User s Manual they must be Reference Date of Birth The age is calculated automatically and Sex for the later availability of the Spirometric Reference Par
86. on 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 lt SOFTWARE 518 Options Maneouvres He FN Seb Printer Selection Exit Initial Time 1 0 References Adult 5 Child 5 WILSON 1 2 M3 M4 5 OK Exits from the dialogue box updating the changes Cancel Exits from box without updating the changes Help It shows the help 15291 sainssaid 1 z XaNNV ANNEX 2 Maximal pressures test Sibelmed SIBELMED W 20 User s Manual 156 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 it up between 0 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 colourrsets for the drawing of the memorised curves Sibelmed SIBELMED W 20 User s Manual 157 PROCEDURE FOR THE MAXIMAL PRESSURE TEST To enter the Maximal Pressure test you must press over the Maximal Pressure icon from the main menu INPUT OF PATIENT AND TEST DATA If the patient and test data have been previously entered the program will dire
87. or each parameter which appears in the trends report These parameters are the following FVC FEV1 PEF and the Variability 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 percentaje 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 Chapter 1 Instructions of use and instalation SIBELMED W 20 User s Manual 50 EXPLORE DATA BASE w 20 Data Base 7222222222 Sanchez Grau 3333333333 Marcus Fernandez Juan 4444444444 Perez Anna 5555555555 Ramus Garcia Peden 666666666 Pando Miert Jos This window allows viewing the data base patient s list with their corresponding tests and it also has the next menu options e Setup e Data Base e Options e Window e Help Some qui
88. owed on them Chapter 1 Instructions of use and instalation sibelmed SIBELMED W 20 User s Manual 52 OPTIONS TEST DATA This screen presents the Test Data performed to the patient in the date and time indicated in the same card rest ostata bay Month Year Betevenue Tine 5 PARAMETER ont Wert FEY 1 C a Cough C br Ditt nm C C 21 4 4 gt The following options are allowed Delete deletes all the information related to this test Restore allows to restore a deleted test Test Datl presents the information related to the test Graphic displays the graphic corresponding to the test Report allows to make 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 Preliminary View shows a preliminary view of the test s report It presents the following information sibelmed SIBELMED W 20 User s Manual e It warns if the patient had cough gasping breathing difficulty or mucosity during the test everyone of this symtomps can take the next values White No symptom Green Low Symptom Yellow Medium Symptom Red High Symptom e It warns if the test met the ATS criteria regarding TT time of test FP final of test EX start
89. rinter type and the Display Parameters Selection It allows to select 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 the group will be selected It is also possible to add tests for this purpose press the 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 sympthoms of each test as superimpossed areas and the numeric values of the selected parameter as XY The warnings are represented with a colour 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 6 SIBELMED W 20 User s Manual Parenter Mineum 30 29 FEVI 20 PEF 50 460 9 69 Show wi the In this window it is possible to set the maximum and minimum values f
90. rning If you are working with an old data base 2 07 version or previous deleting and packing operations are not allowed on them SIBELMED W 20 User s Manual 57 EXPORT CSV FORMAT TESTS 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 ixi 72972922 MI 454441444 55555555565 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 appears Clicking with the mouse s right button over one test a menu appears with the next options DELETE it allows deleting the test 5 pue ASN Jo 5 T 1e3deu Sibelmed SIBELMED W 20 User s Manual 58 RECOVER it allows recovering the test if it is marked to be wiped Double clicking over a test makes the tests window appear 3 Introduce 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 performi
91. s finished it is necessary to adapt it to the needs of each user Thus the system will be configurated in each case and its handling and understanding of the functioning will be easier Next the different options that can be configurated are detailed PRINTER SELECTION Select the option PRINTER SELECTION into the SETUP The selection is made by placing the mouse cursor over the label SETUP and pressing the mouse left button Next the same over the label PRINTER SELECTION The 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 SEE SIBELMED W 20 User s Manual 37 PARAMETERS DIAGNOSIS REFERENCES AND OTHERS PARAMETERS AND OTHERS SELECTION Select the option PARAMETERS AND OTHERS SPIROMETRY inside the SETUP Seloct Parameters and Others 7 tetive gt n 2 FIVC Ur PV Ind l min fe raves o 9 ss ratings Ww iv 1 49 FEFEOCSFIREOe jo FIVL FIVC 9 10 np ov trai mrt wv FRVAIFIVI 5 2 CORD indes 8 pvo syve 4 72 frvirrivo t nr 1 41 Lang Age F mawe 0 j 17 FEYI PRT i 9 17 OC Grade 9 wevayree 8 9 17
92. selected in the spirometer and the highest one is suggested unless some error is detected DEVICE CHECK This option allows to check 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 In 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 SIBELMED W 20 User s Manual 43 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 meteorologic station cru aro WAIT SpO2 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 UTILITIES Depending on the selected device the Utilities menu will appear in the Links menu with the next options D70 e Activation Code e Software purchase Uuomej ejsui pue Jo suoij2n4j
93. so presents D R graph Dose Response 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 1591 10 01321135 020 2 XANNV ANNEX 3 Bronchoconstriction or bronchial provocation test Sibelmed SIBELMED W 20 User s Manual 176 The steps for the test are the following ist Step BASAL BAS Start the process of forced manoeuvres as described in INPUT OF FORCED VITAL CAPACITY TESTS FVC section inis e 1 LI 3 Li 9 Sibelmed SIBELMED W 20 User s Manual 177 Once the adequate manoeuvres are performed press the DATA icon Manoeuvre Data AVAL Wase lopez Garcia P Mio 1 TAFARETER w F MTPS 1 067 mc n 2 73 n 2 nuo n 3 mvi nt 4 2 2 49 E PIVOT 42 19 4 0 8 0 00 ffe gt Warnings m felected Cough Best I n 4 b Aurore Repkoduet4hility mew Corm owe e The manoeuvres 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
94. ssure for each manoeuvre Gibelmed SIBELMED W 20 User s Manual C Test Summary window or data window This window displays the test data as the manoeuvres are being performed The data are updated after each manoeuvre and when the references are changed in the setup option The average values and the standard deviation are calculated from the best three manoeuvres 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 manoeuvres are ordered as they are being performed This is made because it is important to follow the patient evolution Although the manoeuvres are stored in the memories in temporal order the best three manoeuvres in the window Best manoeuvres are ordered from worst to best one the best manoeuvre is the one with a higher pressure value It is important to point out that although the program has space for 5 manoeuvres more manoeuvres can be performed After performing the sixth manoeuvre the first performed manoeuvre will be deleted M1 provided that this is not the best If this were the best manoeuvre then the second one would be deleted M2 Once the corresponding manoeuvre has been deleted the system will reorder them and the performed manoeuvre will be M5 the M5 will be M4 the M4 will be M3 and so on D Selecting and deleting manoeuvres The value of the selected manoeuvre is shown i
95. stored in the data base The system selects as default the curve for the best manoeuvre 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 manoeuvre from the one selected by the system as default check Selection and deleting of manoeuvres section After the desired manoeuvres of espiratory 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 manoeuvres fisPiROMETRY SOFTWARE SIBELMED Setup Options Maneouvres Help Setup Options Maneouvres Help gt Start Maneouvre Test Data Change Patient Best r Change to Pim Save test 250 Zoom Maximal pressures test ANNEX 2 SIBELMED W 20 User s Manual SIBEL S A Reference 1111111111 Date 28 12 2005 Time 10 59 Name Lopez Garcia Francisco Sex 35 Height 180 Wgt Kg 75 Temp C Pres mmHg 760 Humidity Smok I Motive BMI 23 1 Procedence Technician Transducer Disk References P MORALES Ethnic F Version 51176FA 3 0 MAXIMUM PRESSURES REPORT SIBELMED W 20 4 maxIP maxEP M1 166 203 M2 0 0 M3 0 0 M4 0 0 MS 0 0 Avegage 166 203 Std Dev 0 0 Referenc
96. suboptions following the screen instructions 2 Connect the device to the computer and select the link parameters in Setup Links 3 Select the option Setup Utilities Download data of the device 4 Click on DATA to transfer the information use and instalation of structions nst in hapter 1 7 Sibelmed SIBELMED W 20 User s Manual 110 The data gets stored inside the application directory in the files STATUS CSV Contains the detected errors CALIBRA CSV Contains teh calibratio dats CONFIG CSV Contains the personalization of the device PRUEBAS CSV Contains the tests of the data base GRAFICAS CSV Contains the graphics in Flux Time format 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 AfterSales Department or to your local Dealer If you don t have e mail you can print de data and send them through FAX Sibelmed SIBELMED W 20 User s Manual 111 TECHNICAL SUPPORT If any problem doubt suggestion arises before during or after the use of the device it is recommended to follow these steps 1 Use the helps available in the program 2 Use this User Manual poperly 3 Contact with the After Sales Service of SIBEL S A at SIBEL S A Rossell 500 08026 BARCELONA SPAIN AFTER
97. sug T 4193deu Chapter 1 Instructions of use and instalation Sibelmed SIBELMED W 20 User s Manual 44 0120 D110 Activation Code e Software purchase e Update Flash e Download data of the device D600 e Activation Code e Software purchase e Update Flash This options are explained with detail in the subchapters ACTIVATION CODE SOFTWARE PURCHASE UPDATE DEVICE SOFTWARE and DOWNLOAD DAT OF THE DEVICE respectively at the end of this chapter ABOUT This option shows an information window with the program s data e Version e Date e Manufacturer s Data x Vermon 51176FA3 0 Date 22 11 2005 SIBEL SA C 500 08026 34 33 Fax 34 93 4361611 WEB www tibelmed com lt lt SIBELMED W 20 User s Manual 45 DATA BASE The Spirometry Software SIBELMED W 20 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 WARNING If you are working with an old data base 2 07 version or previous deleting and packing operations are not allowed on them Enter into the exploration window and follow the instructions in order to convert an old data base to the new data base format PATIENT CARD Select DATA BASES PATIENT This screen allows to x Options Index Refere
98. t s advisable to select in the operataing system the big font type for a better visualisation of messages This option is located in the screen properties option consult the operating system manual Sibelmed SIBELMED W 20 User s Manual 33 1 7 INSTALLATION AND PRINTER REQUIREMENTS 0 B er b j The installation of the printer will be carried out according to the Use Manual of the printer itself The printer to be used must meet the minimum requirements detailed next e Windows compatible printer e Resolution 160 9 e 5 pages per minute e Fulfilment of the current applicable guidelines regarding printersimpresoras ABOUT ONSCREEN HELP The onscreen helps included in the Spirometry Software SIBELMED W 20 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 Inside some texts underlined words or sentences are included e g INDEX in green colour 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 Chapter 1 Instructions of use and instalation Sibelme d SIBELMED W 2
99. tall the drivers d ms m Pm Bd d ammi rs De eU Es ___ _ Le b Found Now Hardware res herders sridi and reacts se Ou gt t 22 SIBELMED W 20 User s Manual 3 Initial configuration of the Bluetooth device One the driver is correctly installed if we right click on the Bluetooth icon seen in a previous image which appears on the bottom right hand side the message Start using Bluetooth appears Start the configuration by left clicking on the message Click on Next and enter the name of the equipment on the next screen This is the name that will be used by the Bluetooth device to identify itself to other devices ebd Cond Lube ad Bm m man cm on ape mn Het oe ee um ee gem e med Read SSeS E Gm mon eS ee ehl rE ee ne ee Lee b _ _ _ Once the is entered click on Next to select the profiles or services that you want to install Uomej ejsui pue asn Jo SUOIJINAJSUT 5 Chapter 1 Instructions of use and instalation Sibelmed SIBELMED W 20 User s Manual me
100. ter accessed The format of each of the lines is the following USER YYYYMMDD HH MM SS BASE ACTION ACCESS PATH REFERENCE Sibelmed SIBELMED W 20 User s Manual 191 The database is comprised of a directory and two data files patients dbf and tests dbf as well as auxiliary files indexes z etc The actions to be registered are divided into v e Action on the actual database itself open close delete etc e e Action on the registers stored on the patients dbf and tests 5 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 3 e Opening a db file Closing a db file gt Selecting db e Creating db e Creating a db file e Deleting a db 3 Deleting a db file Re indexing a db file e Wrapping a db file e Changing access password Consulting the register e Adding a register e Marking a register e Recovering register d Changing a register Deleting a register a e Exporting a register e Importing a register Other important subjects Printing documents Sibelmed SIBELMED W 20 User s Manual 192 In the case of storage for paper prints containing patient details gt it is required that said documents remain duly safeguarded in such way that only duly authorized personnel have acc
101. the export module by pressing the EXP icon or going to the Export to Disk option in the Options menu aix TMP gt GRAFODI csv 2 Pruebas csv Tipo Export Files CSV Cancelar When activating the Check box of a patient all his her tests Uuomej ejsui pue asn Jo SUOIJINAJSUT T 5 sibelmed SIBELMED W 20 User s Manual 92 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 suboptions in the menu Selection 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 a
102. the test e Report e Organise Windows INNV X The operative windows allow the display of the pulseoximeter values follow the evolution of the perfusion waveform receive the alarm messages and display the calculated parameters ANNEX 1 Pulse oximetry test Sibelmed SIBELMED W 20 User s Manual They are the following ones e Pulse Oximetry Window e Data Window 138 Sibelmed SIBELMED W 20 User s Manual PULSEOXIMETRY CONFIGURATION It is recommended that any user configures the Pulseoximetry module according to their needs The Pulseoximetry configuration menu is accessible from the main screen in Configuration Parameters and Others Pulseoximetry or from the pulseoximetry tests screen in Configuration Pulseoximetry Ag S IROME TRY SOFTWARE SIDELLMED W 20 Dal fisPiROMETRY SOFTWARE SIBE x Setup Options Help Printer Selection Exit The following dialogue box will appear Pulsioximetry Setup x Alarm limits Max Min 5 02 fi 00 80 120 40 Acoustic Signals Alarm Sound Pulse Beep Average 5 02 8 62 1593 os nd T XANNW Sibelmed SIBELMED W 20 User s Manual 140 OK 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 Maximum and minimum values Alarms of Sp
103. tion test Summary PARAMETER OBS 2 Sibelmed SIBELMED W 20 User s Manual 183 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 are 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 1591 JEIYDUOAG 10 01321135 020 2 XANNV 184 Sibel med SIBELMED W 20 User s Manual 1591 Eeruy2uo4q u0I32113su02042UO4g XANNW Sibelmed SIBELMED W 20 User s Manual 185 4 COMPLIANCE WITH THE DATA PROTECTION ACT DIRECTIVE 95 46 EC 24 9 S6 Je e uerjduio p XANNV Sibelmed SIBELMED W 20 User s Manual 186 COMPLIANCE WITH THE FOR 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 A brief description of the fundamental points of said legislation is given and what needs be done with the SIBELMED W20 Spirometry Software and or operat
104. to its great reliability reproductibility and duration The Turbine Transducer type is a system of good reliability and reproductibility Its duration is limited to the use and care applied to the transducer The Disposable Transducer type is a reliable element and of good reproductibility Its use is adequate in cases where it is necessary to avoid possible infections between patients caused by undetected or ineradicated contaminations due to lack of cleanness in the used neumotachometer or transducer SIBELMED W 20 User s Manual PROCESS OF THE CALIBRATION The steps to follow are 1 Connect the neumotachometer or transducer to the syringe inserting a 1 meter tube to avoid the influence of the turbulences caused by the sudden air output according to the illustration 5 pue ASN JO SUOIJINAYSUT T 1e3deu Chapter 1 Instructions of use and instalation Sibelmed 7 SIBELMED W 20 User s Manual HOSE RECORD SYRINGE FLEISCH PNEUMTACHOMETER CALIBRATION SYRINGE HOSE RECORD SYRINGE TURBINE PNEUMTACHOMETER CALIBRATION SYRINGE TUBE REGISTER DISPOSABLE TRANSDUCER CALIBRATION ADAPTER CALIBRATION SYRINGE SIBELMED W 20 User s Manual 2 From the Main Menu screen click on the icon CAL xi Date 17 01 2006 Technician Volume 8 SIBEL S A N Pulses 200 Last Calibration Temperature 25 Esp Factor 0978 Rel Hum 65 Insp Factor
105. tructing the air passing through when making the spirometric manoeuvre and put him the nasal tweezers 4 Press the START icon and from that moment the patient has 30 seconds to start the forced manoeuvre 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 Fet 10 099 This code will be applied by the equipment and will always 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 introduce the K values Chapter 1 Instructions of use and instalation sibelmed SIBELMED W 20 User s Manual 68 x K1 K2 K3 K4 K5 NM 2 63 Q 5 After the first spirometric manoeuvre the patient can performe the manoeuvres indicated by the technician mle S le MANOEUVRE DATA After having performed at least one spirometric manoeuvre we can enter the Manoeuvre Data window through OPTIONS MANOEUVRE DATA DATA Icon This screen presents all the information related to each performed manoeuvre A is added to REF when the reference values ha
106. um Flow between 75 85 of FVC Time passed between 25 75 of FVC Forced Espiratory Time Relation Relation Relation Maximum Inspiratory Flow when 50 of FVC has been inspired Forced Inspiratory Vital Capacity Forced Inspiratory Volume in 1 second Relation Relation Peak Inspiratory Flow Measured Transit Time Relation Extrapolated Volume related to FVC Sibelmed SIBELMED W 20 User s Manual 116 e MVVInd l min Maximum Voluntary Ventilation indirect 30 x FEV1 FEV6 FEV1 FEV6 COPD Index Lung Age Diagnosis e Miller e Snider Kory amp Lyons Reference Parameters and age range e SEPAR 6 to 70 For ages 6 amp gt 70 years reference values extrapolated e ECCS ERS 18 to 70 For ages gt 70 years reference values are extrapolated e KNUDSON 6 to 84 For ages lt 6 amp gt 84 reference values are extrapolated CRAPO 4 to 91 For ages gt 91 reference values are extrapolated e ZAPLETAL 4 to 17 years e MORRIS 24 to 100 years AUSTRIAN 6 to 90 For 4 years and ages 90 reference values are extrapolated e GUTIERREZ CHILE 5 to 100 For 4 years reference values are extrapolated e BRAZILIAN 6 to 76 For ages 6 amp gt 76 reference values extrapolated e POLGAR WENG 4 to 100 years HANKINSON 4 to 100 years e PEREZ PADILLA MEXICO 7 to 100 For ages 7 years reference values are extrapolated A J CRUZ MEXICO 17 to 64 For ages 17 years reference
107. values are extrapolated GOLSHAN IRAN 6 to 81 For ages lt 6 years reference values extrapolated e Other options Sibelmed SIBELMED W 20 User s Manual 117 Ethnic Factor for Reference values Patient Identification Data Environmental Data temperatura pressure and relative humidity Graphics FLOW VOLUME and VOLUME TIME mode Graphics for motivation in paediatric tests Concordance Manoeuvre Warnings with the ATS criteria SLOW VITAL CAPACITY Parameters e VC 1 Slow Vital Capacity e TV 1 Tidal Volume e ERV 1 Espiratory Reserve Volume e IRV 1 Inspiratory Reserve Volume e IC 1 Inspiratory Capacity e Ti s Inspiratory Time e Te s Espiratory Time e Tt s Total Time e Ti Tt Relation Normalised Reference Parameters to be selected among different standards Ethnic Factor for Reference values Patient Identification Data Environmental Data temperatura pressure and relative humidity PLA SIBELMED W 20 User s Manual 118 Graphics in VOLUME TIME mode MAXIMUM VOLUNTARY VENTILATION Parameters e MVV l min Maximum Voluntary Ventilation e Br min Br min Breathing Frequency of MVV Normalised Reference Parameters to be selected among different standards Ethnic Factor for Reference values Patient Identification Data Environmental Data temperatura pressure and relative humidity Graphics in VOLUME TIME mode POSTBRONCHODILATION TEST Same parameters as in FVC Comparing met
108. vanced 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 any 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 permissions 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 in the lt W20_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 W20 HOME 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 always have read and write access for their subdirectory and the files that make up the subdirectory The rest of the users ma
109. ve been extrapolated and in the report appears the text Warning iReference values extrapolated We can distinguish the following parts Sibelmed SIBELMED W 20 User s Manual 69 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 In the case of POSTbronchodilation the following columns appear PRE PREbronchodilation Value REF Reference Value between PRE REF POST POSTbronchodilation Value P between the POST PRE or other according to setup R between REF and POST It appears depending on the configuration of the previous parameter WARNINGS Allows to note down if this is the case one or several events related Everyone of this symtomps can take the next values White No symptoms Green Low Symptoms Yellow Medium Symptoms Red High Symptoms BEST Indicates the technician of the test the best values for FVC and FEV1 of all the made manoeuvres MANOEUVRE SELECTED Indicates the number of selected manoeuvre being displayed on screen Any available manoeuvre can be selected up toa maximum of eight The order of the manoeuvres is presented according to the ATS criterion American Thoracic Society of maximum addition of FVC FEV1 being the number 1 the one of highest addition the best manoeuvre and number Sibelmed SIBELMED W 20 User s
110. y 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 Sibelmed SIBELMED W 20 User s Manual 189 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 actions performed 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 W20 HOME MBdsibel 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 log file are audited the security events viewer will have many more entries and will complicate the monitor
111. ystem 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 all of the 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 and Vista 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 Sibelmed SIBELMED W 20 User s Manual 188 Setup of Identification 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 Passwords icon on the Control Panel Using the Ad

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