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1. DATOSPIR MICRO User s Manual 3 10 INTERNAL DATABASE The DATOSPIR MICRO has an Internal Database as standard which saves the different tests made using the equipment and subsequently displays them prints them and or transfers them to a PC or other computerised system for storage or management The base information remains even when the equipment is unplugged There are two bases with the same functions but different capacities Database L Database H The tests that can be saved using six second FVC as reference are Database L 150 Database gt 1000 The saving of the tests has already been described the sections corresponding to each test The database always saves all the spirometric parameters of each of the different test modalities VC MVV or Dilation despite them not being selected in the Customisation programme Different functions are possible from the spirometer 1 Search the database 2 Search for a patient FS DATOSPIR MICRO User s Manual 3 Search for a register 4 Print a summarised report 5 Delete the database To do so start the DATOSPIR MICRO using the key and wait for the following screen to appear 93 96 96 DATOSPIA MICRO 18 10 mur BLUE Sw TOOTH a Press to access the screen with the options to be chosen with the database 03 0606 DATABASE 18 11 mm ESC Ej
2. DATOSPIR MICRO User s Manual 3 MODELS B AND OPERATI ON pue sjapow 2 S belmed DATOSPIR MICRO User s Manual 98 All of the sections in this Chapter except for 3 13 HOME MODE OPERATION refer to HOSPI TAL MODE 3 1 FUNCTION TREE The DATOSPIR MICRO spirometer function tree is shown to enable a better understanding of its structure This structure corresponds to Models B and C and is characterised by the fact that it contains graphic menus To move around the different equipment menus DATOSPIR MICRO Models B and C have a pointer to select the icons appearing on screen The character number or letter must also be selected to write in the numeric or alphanumeric fields using the pointer WARNING It is recommendable to use the pointer included with DATOSPIR MICRO SIBEL S A is not responsible for any damage caused where other pointers are used Pointed objects must not be used under any circumstances The following can be accessed from the Main Menu depending on the options included SPIROMETRY CALIBRATION DATABASE CUSTOMISATION MAINTENANCE OPERATING MODE PULSE OXIMETRY DILATION REPORT BLUETOOTH DATOSPIR MICRO User s Manual SPI ROMETRY Forced Vital Capacity FVC Test Test data Patient Code Full name Age height weight and sex Smoker index Ethnic factor Atmosphere Temperature Start of the spirometric man
3. 156 Srbelmed DATOSPIR MICRO User s Manual 157 m a a ct Go back to the main screen Search for patient Search for register Search the database Summarised report AEE Delete the database DATABASE SEARCH Select the option to display the tests saved on the database REGISTER NUMBER Pat Code FEv1 WC 3 76 My 167 6 vc D 3 76 MwY D 1467 ESC Go back to the previous screen 3 c c c 5 pue FS 5 7 DATOSPIR MICRO User s Manual 158 and b Fast back forwards through the registers The movement value is configured in the Customisation menu Deletes the test selected Displays the test selected 4 and 7 Moves around the different tests Select a test and press The following screen is accessed Es i 1 1 REF 5 50 4 33 5 42 3 88 Go back to the previous screen Display test data Display the test diagnosis y Print the test ime Sibe med DATOSPIR MICRO User s Manual 159 Pressing the axes changes the type of graph Flow Volume or Volume Time e Pressing the graph area makes the buttons disappear and makes it larger or smaller PATIENT SEARCH Select the option 1 to search patient in the database The following screen will appear PATIENT SEARCH Enter the patient code and press I
4. Chapter 2 Model Operating FS SS DATOSPIR MICRO User s Manual to search for a patient in the database Press the key gt and enter the patient code REGISTER SEARCH Select the option DATABASE 3 Search Reg to search for a register in the database Press the gt key and enter the register number SUMMARISED REPORT Select the option DATABASE 4 Summ Report to print a report with the list of tests saved in the database Press the key gt DELETE DATABASE Select the option DATABASE 5 Delete DB to delete the entire database Press the key gt Sibel med DATOSPIR MICRO User s Manual 77 2 10 MAINTENANCE PROGRAMME The equipment has a maintenance programme to adjust and or check the working order of certain options From the Main screen press keys or v to choose MAIN MENU 5 Maintenance Press the key gt to access the Maintenance options Using keys v you can move around the different options to 1 Configure the calibration and or maintenance warnings 2 Adjust the screen contrast 3 Auto check the equipment 4 Configure the equipment 5 Check with pre saved standard curves WARNINGS Select the option MAINTENANCE 1 Select Warning jepoyw 5 DATOSPIR MICRO User s Manual This option indicates the tests completed and allows for the periods in da
5. 27 2 MODEL 29 2 1 30 2 2 EQUIPMENT CUSTOMISATION 34 2 3 EQUIPMENT PROTECTION 38 2 4 FORCED VITAL CAPACITY FVC TEST PROCEDURE 39 2 5 SLOW VITAL CAPACITY VC TEST PROCEDURE 59 2 6 MAXI MUM VOLUNTARY VENTI LATI ON MVV TEST PROCEDURE 61 2 7 POSTBRONCHI AL DI LATOR SPI ROMETRY PROCEDURE 63 2 8 CALI BRATION PROCEDURE 66 e2ipu indice 5 Manual de Uso DATOSPIR MICRO 10 2 9 4 73 2 10 MAINTENANCE PROGRAMME 77 2 11 UPDATI NG I NTERNAL SOFTWARE 84 2 12 HOME MODE 5 88 3 MODELS B AND OPERATION 97 1 FUNCTION TREE 98 3 2 EQUIPMENT CUSTOMISATION 103 3 3 EQUIPMENT PROTECTION 4 4 110 3 4
6. To change the PIN you must enter the current one in the Current Pin box If an erroneous PIN is entered three times the equipment will lock and switch off The PIN can be re enabled by entering the current PIN and unticking the Pin Enabled checkbox Srbelmed DATOSPIR MICRO User s Manual 109 DATABASE CUSTOMISATION This option allows you to choose the number of registers to be advanced if performing a fast advance using the database search engine DB EXPLORER FAST ADwAMCE Mo of Resisterz 18 S be med DATOSPIR MICRO User s Manual 3 3 EQUIPMENT PROTECTI ON If equipment protection has been enabled the following screen will appear when it is started ENTER Enter the PIN and press If the PIN configured in Equipment protection customisation is entered access will be given to the DATOSPIR MICRO and the main screen will appear If an erroneous PIN is entered three times the equipment will lock and switch off The following screen will appear when it is restarted ENTER UNLOCK CODE 2 3 4 5 6 7 8 9 Enter the unlock code PUK supplied upon purchasing the equipment and press Srbelmed DATOSPIR MICRO User s Manual 111 If the correct code is entered the DATOSPIR MICRO will unlock and the main screen will appear From then on the equipment will return to its initial status Protection disabled and PIN 0000 If an erroneous code is entered the equipment will
7. The specialist will explain the test to the patient particularly the forced expiration manoeuvre process the equipment operating sequence and when the tests should be taken The operating sequence is as follows If start up is manual the patient starts the equipment DATOSPIR MICRO User s Manual 1 The start screen will appear along with the model the programme version and the bios version programme run during booting the date and the time If start up is automatic because it is the time programmed in Alarms 1 The equipment will start up and the start screen will appear along with the model the programme version and the bios version the date and the time The following screen will then appear START THE TEST PRESS THE KEY and the equipment will issue a beeping sound every 10 seconds If for 2 minutes gt is not pressed the equipment will switch off Press the key gt 2 The following screen will appear BLOW The patient is given 30 seconds to start the FORCED EXPIRATION manoeuvre 3 The following screen is then displayed BLOW AGAIN S be med DATOSPIR MICRO User s Manual 94 4 The patient has to perform three expiratory manoeuvres After the three manoeuvres an arrow will appear to indicate the semaphore zone in question GREEN YELLOW or RED in line with the programme produced by the specialist The equipment automatically saves the
8. 1 ERV 1 e IRV 1 IC 1 Ti s Te s Tt s e Ti Tt Slow vital capacity Tidal volume Expiratory Residual Volume Inspiratory Residual Volume Inspiratory Capacity Inspiratory time Expiratory time Total time Ratio Percentage deviation in relation to values of reference Standardised values of reference that can be selected from several standards Patient s I D details Atmospheric data on temperature pressure and relative humidity Graphs in VOLUME TI ME mode Saving of five manoeuvres from the same test 5 DATOSPIR MICRO User s Manual 193 MAXIMUM VOLUNTARY VENTILATION Parameters MVV l min Maximum Voluntary Ventilation Br min Br min Breathing frequency of MVV Percentage deviation in relation to values of reference Standardised values of reference that can be selected from several standards Patient s I D details Atmospheric data on temperature pressure and relative humidity Graphs in VOLUME TI ME mode Saving of five manoeuvres from the same test POST BRONCHI AL DILATI ON TEST Same parameters and characteristics as in FVC Several methods of comparison among PRE POST and REF values Superimposing of PRE and POST graphs SpO PULSE OXI METRY The DATOSPIR MICRO allows for specific or long term measurements lasting for 8 hours S be med DATOSPIR MICRO User s Manual 194 Parameters CT90 of time in which SpO is belo
9. 196 5 4 PRESENTATION OF DATA 198 5 5 TEMPERATURE SENSOR 198 5 6 GENERALDATA 55 ssa ss sano nn hag sun aaa RARE RR AR RR 198 6 OPERATING PRINCIPLES 201 6 1 TURBINE esos ES Eu kl ERR ER LEER ES a 202 6 2 TURBINE ROTATION SENSOR 202 6 3 MICROPROCESSOR 203 6 4 PULSE OXI METER 4 205 7 SPIROMETRY TECHNIQUE 207 7 1 545 Dn ERE FADA CE 208 7 2 CALIBRATIONS ERR Rus 209 indice Manual de Uso DATOSPIR MICRO EET 7 3 VALUES OF REFERENCE FOR FORCED SPI ROMETRY SEPAR 22 aar 7 4 VALUES OF REFERENCE FOR FORCED SPI ROMETRY ECCS9 3 7 5 OTHER VALUES OF REFERENCE 8 UPKEEP PREVENTATIVE AND CORRECTIVE MAINTENANCE 8 1 UPKEEP sc is
10. CABLE MINI USB MANUAL DE USO USER MANUAL SOFTWARE ESPIROMETRIA W 20 DEMO Compuesto por SPIROMETRY SOFTWARE W 20 Composed by e SOFTWARE W 20 CD LICENCIA SOFTWARE ESPIROMETR A W 20 SPIROMETRY LICENSE SOFTWARE W 20 OPCI N PULSIOXIMETRIA SOFTWARE W 20 PULSEOXIMETRY W 20 SOFTWARE OPTION OPCION BRONCOCONSTRICCION SOFTWARE W 20 BRONCHOCONSTRICTION W 20 SOFTWARE OPTION OPCION IMPRESORA EXTERNA USB USB EXTERNAL PRINTER OPTION CABLE MINI USB 5 PINES USB MODULO PULSIOXIMETRIA SENSOR FLEXIBLE Compuesto por FLEX PULSEOXIMETRY MODULE Composed by e MODULO PULSIOXIMETRIA XPOD XPOD PULSEOXIMETRY MODULE e SENSOR PULSIOXIMETRIA FLEXIBLE SPO2 FLEX PULSE OXIMETRY SPO SENSOR e ADHESIVO SENSOR PULSIOXIMETRIA 25 255 PULSIOXYMETRY PROBE ADHESIVE 25 lt lt lt lt lt lt lt lt lt lt GS lt I 4 4 pue asp 10 54013214354 uol for Use and I nstallat Instructions Chapter 1 Sib 5 DATOSPIR MICRO User s Manual RELACION DE CONTENIDO PACKING LIST C DIGO CODE 511 AJ0 000 511 AB0 001 511 AJ0 001 511 AC0 000 511 AL0 000 511 AL1 010 511 AD0 000 511 AE0 000 511 AH0 000 321 700 010 CANT QTY DESCRIPCI N DESCRIPTION MODULO PULSIOXIMETRIA SENSOR PINZA Compuesto por PULSEOXIMETRY MODULE ARTICULATED SENSOR Composed by e
11. OPERATING MODE BLUETOOTH 1 5 1 Forced Vital Capacity Test 1 Start manoeuvre 2 Results Srbelmed DATOSPIR MICRO User s Manual Diagnosis Save DB Save PRE Report Delete New patient 43 0 VC Slow Vital Capacity Test 1 Start manoeuvre 2 Results 3 Save DB 4 Save PRE 5 Report 6 Delete 7 New patient 3 MVV Maximum Voluntary Ventilation Test Start manoeuvre Results Save DB Save PRE Report Delete New patient 4 Dilation Post bronchial dilation test 1 PRE manoeuvres 1 Start manoeuvre Results Diagnosis Save DB Report 6 Delete 2 Delete PRE AUN 5 Total Report 6 New Patient 2 CALI BRATI ON 31 jepoyw Chapter 2 Model A Operating FS ST S be nmed DATOSPIR MICRO User s Manual Calibration DB calibration 1 Register Data 2 Delete Register 3 Report DATABASE Search DB 1 Results 2 Diagnosis 3 Report 4 Delete test Search patient Search register Summarised report Delete DB CUSTOMISATION Spirometry 1 References 1 Adults 2 Children 3 Ethnic Factor 2 Parameters 1 FVC 2 VC 3 MVV 3 Graphics 4 Diagnosis 5 Dilation modes 6 Warnings Home mode 1 Patient details 2 Test data Printers 32 Srbelmed
12. Sibelmed DATOSPIR MICRO User s Manual Select the curve type and follow the instructions on the screen which are similar to the FVC VC and MVV procedures With these curves you can operate the equipment as if they were real patient curves with slight exceptions EQUIPMENT CONFIGURATION Select the option to configure different options of the equipment 93 96 96 CONFIG EQUIP 18 5 1 mn ESC Go back to the previous screen ESET E Reset all equipment variables Reindex the database Change from positive VC to negative VC and t vice versa m An updating key is also displayed which is necessary for updating the equipment and obtaining a new improved version of it 5 DATOSPIR MICRO User s Manual 168 3 12 UPDATING INTERNAL SOFTWARE The DATOSPIR MICRO spirometer has two types of internal software Bios basic hardware control programme Flash programme containing all the equipment options The update option allows for the version of Bios and or Flash to be updated without having to take the equipment to the factory and without having to open it WARNING Both updates are completed through the serial port RS232 BIOS UPDATE The updating process for the BIOS programme is as follows 1 Run the W 20 Spirometry Software and access the Configuration Hardware Test option Run a communications test to check that the connections are correct 2 Switch the
13. Switch off the DATOSPI R MICRO The updating process is as follows l Run the W 20 Spirometry Software and access the Configuration Hardware Test option Run a communications test to check that the connections are correct 2 Switch off the DATOSPIR MI CRO 3 Start the DATOSPIR MICRO while keeping the top right of the screen pressed down This runs the programme in BIOS to update FLASH 4 The BIOS access key press 3 and then 4 is then requested to prevent any user from accessing it by mistake 5 Copy the new file provided by SIBEL containing the update DMFlash tsk to the V FIRMWARE directory of the application W20 Srbelmed DATOSPIR MICRO User s Manual 171 6 Run the W 20 Spirometry Software access the Configuration Links option and check that the DATOSPI R MICRO is selected 7 Access the Configuration Utilities Update Flash option the W 20 Spirometry Software in demo mode provided upon purchasing the equipment is enough A dialogue box will open where the update key the one previously consulted if this is a version update or the one provided by SIBEL if it is an option update must be entered 8 The new programme will be transmitted The process may take around 10 minutes depending on the PC 9 Switch off the DATOSPIR MICRO o1deu 5 J A e pue g 5 DATOSPIR MICRO User s Manual 172 3 13 HOME MODE OPERATI ON DATOS
14. DATOSPIR MICRO User s Manual 180 HAVE YOU MUCOSIT YS MEDIUM HIGH Upon pressing the following screen appear indicating that the test has been saved on the database IMPORTANT NOTE Proceed as follows to go from HOME MODE to HOSPITAL MODE For equipment with the key DATOSPIR MICRO User s Manual Keep the lower right of the screen pressed down and restart by pressing The following warning will appear on screen after few seconds RELEASE THE KEYS Then release the lower right of the screen The spirometer is now in HOSPI TAL mode DISPLAYING SAVED INFORMATION The information saved be displayed on the DATOSPI R MICRO spirometer or on the PC using the W20 Spirometry Software In both cases the aforementioned options can be chosen consulting parameter printing a report etc 5 pue g sjapow Chapter 3 Models Operation DATOSPIR MICRO User s Manual DATOSPIR MICRO User s Manual 4 COMMUNICATIONS SYSTEM Ul91s S 1Jo3deu Communications Als 4 lapter Ch Sy 5 DATOSPIR MICRO User s Manual 184 One of the great qualities of the DATOSPIR MICRO is its Communications System with other means that enable it to Transfer Equipment Checking Data Updating
15. DATOSPIR MICRO User s Manual 4 Standard 1 Retrieve standard 2 Modify standard Battery Language Set clock Pin MAINTENANCE Warnings 2 LCD contrast 3 Equipment check 1 Printer 2 CPU 3 LCD 4 Keypad 5 ADCs 6 Inputs 4 Equipment config 1 Reset 2 Reindex 3 Calibrate 4 VC mode 5 Update PIN 5 ATS curves 1 FVC 2 VC 3 MVV 6 OPERATI NG MODE 1 Home mode 2 Hospital mode 7 BLUETOOTH 33 jepoyw 5 DATOSPIR MICRO User s Manual 34 2 2 EQUIPMENT CUSTOMI SATI ON Every user should customise the DATOSPI R spirometer according to his requirements due to the multiple variety of options included The different options included in the Customisation menu are explained in detail in the previous section SPIROMETRY CUSTOMISATION This option customises any suboptions specific to the spirometric tests 1 References The type of reference required can be selected SEPAR ERS KNUDSON CRAPO ZAPLETAL MORRIS AUSTRIA GUTIERREZ CHILI CASTRO BRAZIL POLGAR WENG P PADILLA MEXICO HANKINSON A J CRUZ MEXICO GOLSHAN IRAN for adults and children and the ethnic factor It prioritises the age range selected for adults if a different table is chosen for children It extrapolates the values for the ages outside the table range selected 2 Parameters The observed or measured parameters
16. and PR value is 0 will not be taken into account when calculating the parameters and the length of the test CONFIGURATION While the oximetry signals are being acquired it is possible to access the average SpO and beeping sound signal coinciding with each pulse configuration menu Press and you will access the same screen indicated in the PULSE OXIMETRY CUSTOMISATION section to modify these two parameters S be med DATOSPIR MICRO User s Manual DISPLAYING TRENDS You can only access the trends menu if the study has been saved Press EET it 0123456783 17 54 83 06 PULSE On SB ESC Exits this screen and goes back to the previous one gt Goes back or forwards one page m Locates the next crossing point with the reference line Displays the other buttons Configures the trends screen Calculates displays the value of the parameters The screen displays the fragment of the SpO and PR signal according to the screen time selected The top left shows the relative time at the start of the study hh mm ss Each channel allows for a dotted line of references to be displayed that can be selected by the user during configuration This line may be extremely useful when checking whether the samples exceed a certain value 6 DATOSPIR MICRO User s Manual 145 PRINTING AND OR MEMORISING THE DATABASE The par
17. dispose of the product with domestic waste However any removal of this type of waste is the responsibility of the user and must be taken to a designated collection point for the recycling of electrical and electronic appliances The separate recycling and collection of this waste at the time of Safety FT SS T DATOSPIR MICRO User s Manual 8 removal will help preserve natural resources and ensure that recycling protects your health and the environment Should you require further information on the places where you can leave this waste for recycling contact the local authorities in your town or city the domestic waste management service or the distributor who sold you the product S 6e med Manual de Uso DATOSPIR MICRO INDEX DECLARATION OF CONFORMITY 7 a ANSA EUNERE 9 1 INSTRUCTIONS FOR USE AND INSTALLATI ON 13 1 1 INTRODUCTION 14 1 2 PRIOR OBSERVATIONS 15 1 3 DATOSPIR SPI ROMETER MODELS 16 1 4 LAYOUT OF CONTROLS PI LOT LI GHTS AND CONNECTORS 20 1 5 INSTALLATION AND START UP 22 1 6 5
18. emissions EN IEC 61000 3 3 Not applicable Datospir Micro works with batteries DC USB power SST MB DATOSPIR MICRO User s Manual Guidance and manufacturer s declaration electromagnetic immunity Datospir Micro is intended for use in the electromagnetic environment specified below The costumer or the user of Datospir Micro should assure that it is used in such an environment Immunity test EN IEC 60601 test level Compliance level Electromagnetic environment Guidance Electrostatic discharge ESD 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floors are covered with 8 kV air 8 kV air synthetic material the relative humidity EN IEC 61000 4 2 should be at least 30 Electrical fast 2 for power supply 2 kV DC USB 5V power transient burst EN IEC 61000 4 4 lines 1 kV for input output lines Not applicable The input output line cables are shorter than 3 meters long Surge EN IEC 61000 4 5 1 kV differential 2 kV common mode Not applicable Not applicable Datospir Micro works with batteries DC USB power The input output line cables are shorter than 3 meters long Voltage dips short interruptions and voltage variations on power supply input lines EN IEC 61000 4 11 5 Ut gt 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 70
19. manoeuvre If you press the gt key to delete the manoeuvre the following screen will appear MANOEUVRE N X DELETED OTHER TESTS ON THE SAME PATI ENT You can do the following after carrying out the FVC test on a patient DATOSPIR MICRO User s Manual A VC on the same patient An MVV test on the same patient A Post bronchial dilation test on the same patient Print the general report of all tests on the same patient Start the test process on another patient The spirometer saves the best manoeuvre of each FVC VC MVV and or Bronchial dilation test to print a general report where required containig them all before going on to another patient From the next screen and using keys or v select any of the first four options CHANGE PATIENT This option is used to enter a new patient or to change some details of an existing patient The process is similar to that described in the previous section but previously selecting the option FVC TEST 8 New patient Press the gt key and the following screen will appear PATIENT DETAILS Code 0000000000 Enter the patient code required between 0000000000 and 9999999999 S be med DATOSPIR MICRO User s Manual If you wish to modify some details of an existing enter his code Follow the procedure designed in the ENTERING PATIENT PARAMETERS procedure to enter the details of a new patient or to modify the details
20. 0 0062P 0 21 6 64 7 77 1 45 1 50 0 66 0 88 1 39 1 42 0 80 0 89 0 832 0 789 0 907 0 879 0 856 0 803 0 760 0 709 amp DWOANNNOU SEE 0 443 0 313 0 378 0 263 0 796 0 651 1 073 0 831 0 811 0 669 0 562 0 507 0 530 0 403 0 444 0 307 1 000 0 680 1 470 1 040 1 300 0 925 0 620 0 405 NE S be imed DATOSPIR MICRO User s Manual M male F female R multiple correlation coefficient SEE typical estimate error T height cm P weight Kg E age years The parameters with an asterisk are not listed in the SEPAR standard 7 4 VALUES OF REFERENCE FOR FORCED SPIROMETRY ECCS 93 Standardized Lung Function Testing Official Statement of the European Respiratory Society Luxembourg 1993 Variable Sex Equation Age 18 70 RSD 1 64RSD FVC M 5 76H 0 026A 4 34 0 61 1 00 F 4 43H 0 026A 2 89 0 43 0 71 FEV1 M 4 30H 0 029A 2 49 0 51 0 84 F 3 95H 0 025A 2 60 0 38 0 62 FEV1 FVC 0 18A 487 21 7 17 11 80 F 0 19A 89 10 6 51 10 70 FEF 25 75 M 1 94H 0 043A 2 70 1 04 1 71 F 1 25H 0 034A 2 92 0 85 1 40 PEF M 6 14H 0 043A 0 15 1 21 1 99 F 5 50H 0 030A 1 11 0 90 1 48 FEF 75 FVC 5 46H 0 029A 0 47 1 71 2 81 F 3 22H 0 025A 1 60 1 35 2 22 FEF 5096FVC M 3 79H 0 031A 0 35 1 32 2 17 F 2 45H 0 025A 1 16 1 10 1 81 FEF 25 FVC M 2 61H 0 026A 1 34 0 78 1 28 F 1 05H 0 025A 1 11 0
21. 07 e mail export sibelmed com Technical service Tel 34 93 433 54 50 e mail sat sibelmed com Fax 34 93 436 16 11 Website www sibelmed com SI BEL S A belongs to SI BELGROUP Sibel 6 DATOSPIR MICRO User s Manual 3 DECLARATION OF CONFORMITY The DATOSPIR MICRO Spirometer has been designed by the SIBEL S A R amp D amp i Department with the cooperation of the Hospital de la Santa Creu y Sant Pau Pulmonary Function Laboratory in Barcelona in line with the standardisation criteria of International Institutions ATS ERS TASK FORCE American Thoracic Society European Respiratory Society and National Institutions SEPAR Spanish Neumology and Thoracic Surgery Society The DATOSPIR MICRO Spirometer has been designed and manufactured according to the SIBEL S A Quality Manual which is compliant with 13485 and 150 9001 quality standards with spirometers for peak espiratory flow UNE EN 13826 as well as European Directive 93 42 EEC concerning Medical Devices According to this Directive the equipment is Class It is also compliant with Electrical Safety standards EN 60601 1 EN 60601 1 1 and Electromagnetic Compatibility standard EN 60601 1 2 as indicated in APPENDIX 1 ELECTROMAGNETIC COMPATIBILITY COMPLI ANT PRODUCT C C 93 42 EEC Medical Device Directive 0318 Class 1 Revised Approved Date August 2009 Date August 2009 Jos Maria Plana Carlos Recio Technical Direc
22. 1 Complete a FVC VC or MVV test on the patient before applying the dilating drug as described in the previous sections 2 Memorise the PRE test in the database to compare it in POST mode as explained in MEMORISING FVC TESTS in Section 2 4 3 Apply the dosage of bronchial dilating drug established by the specialist to the patient and wait for the standardised period 4 Go back using the 4 key to the Test Selection window and select using keys or v j SPIROMETRY 4 Dilation 5 DATOSPIR MICRO User s Manual Select the screen DILATION 1 PRE manoeuvres and press gt tests memorised in PRE mode will then be displayed 5 Select the PRE test with which it is to be compared and press 6 The proceed as indicated in Section 2 4 FVC TEST PROCEDURE The only variation is in point 5 as the is weighted in relation to the observed values in Pre bronchial and Post bronchial mode If the printed report is requested the data is presented as shown below Three columns of data can be seen e PRE PRE bronchial dilator Observed Values POST POST bronchial dilator Observed Values WGT weighted between the POST and PRE values WGT 100 x 2 POST PRE POST PRE See J E Cotes Lung Function Assessment and Aplication in Medicine Blackwell Sci 4th Edition 1979 p52 53 S Ge med DATOSPIR MICRO User s Manual Sibelmed DATOSPIR MICRO SIBEL S A ROSSELLO 500 08026 BARCEL
23. 26 957 27 283 MHz 40 66 40 70MHz DATOSPIR MICRO User s Manual Recommended separation distances between portable and mobile RF communications equipment and Datospir Micro Datospir Micro is intended for use in an electronic environment in which radiated RF disturbances are controlled The costumer or the user of Datospir Micro can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and Datospir Micro as recommended below according to the maximum output power of the communications equipment Rated Maximum output Separation distance according to frequency of transmitter power of transmitter 80 MHz to 800 MHz 800 MHz to 2 5 GHz 3 5 7 3 3 0 01 0 12 0 23 0 1 0 37 0 74 1 1 17 2 33 10 3 69 7 38 100 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 800 MHz the separation distance for the higher frequency applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absortion and reflection from structures objects and people
24. 4 The screen shows a list of the tests transferred and you can select those to be imported to the PC Database selected in the W 20 Software Configuration option Sibelmed DATOSPIR MICRO User s Manual 187 5 From then on you can select view or print any of the tests imported or transferred to the PC 4 3 EXPORTING TESTS TO OTHER SYSTEMS The DATOSPIR MICRO spirometer can export the tests saved previous to the Internal Database to other management systems in each hospital The equipment shows the information in comma delimited mode making it compatible with many different systems The information is available in the following files PRUEBAS CSV Contains the database tests PATI ENTS CSV Contains the database patients GRAFxx CSV Contains the graphs in Flow Time mode The graph file as indicated contains the graphs for each test in Flow Time mode If you want to display the graphs in Volume Time or Flow Volume mode in the new management system the following aspects must be taken into account The Flow signal with the turbine type transducer is sampled at 50Hz The ratio of the axes in the Volume Time graph must be adjusted to 1 litre 2 seconds The ratio of the axes in the Flow Volume graph must be adjusted to 2 1 5 11 In the event of doubt or queries contact the SIBEL S A Technical Service or your distributor who will provide any further information you may require Chapter 4 Communications s
25. 425383 E SEARRR TERR RA RON ES FREE NERONE 8 2 PREVENTATIVE MAINTENANCE 8 3 CORRECTIVE MAINTENANCE APPENDIX1 ELECTROMAGNETIC COMPATIBILITY APPENDIX 2 COMPLIANCE WITH THE DATA PROTECTION LOPD APPENDIX3 MODIFICATIONS S be tmed DATOSPIR MICRO User s Manual 1 INSTRUCTIONS FOR USE AND INSTALLATION uonejje3su pue esf suononaasu 4 4 5 DATOSPIR MICRO User s Manual 1 1 INTRODUCTI ON The DATOSPIR MI CRO spirometer is a compact device with a 2x16 screen Model A or a high resolution graphic touch screen Models B and C depending on the model It works with turbine type transducers that can be connected to an external printer by USB It can incorporate a module for pulse oximetry measurements SpO Furthermore using software included depending on the model it can be connected in real or deferred time to a PC for spirometric tests with PC support to save completed tests or to transfer data via other means It can be connected to the PC using an RS 232 cable a Mini USB cable included as standard or by Bluetooth optional The entire system is controlled by a microprocessor for the acquisition calculation and presentation of alphanumeric and graphical data The DATOSPIR MICRO is
26. 69 1 13 M male F female H height m A age years RSD Residual Standard Deviation According to ATS ERS standardisation parameters MEF25 MEF50 MEF75 are replaced by FEF75 FEF50 and FEF25 Between the ages of 18 and 25 25 is replaced in the equations Spirometry Technique pter 7 S be med DATOSPIR MICRO User s Manual IMPORTANT NOTE The DATOSPIR MICRO spirometer allows for an ETHNIC FACTOR to be entered which modifies the values of reference for certain groups of the population This factor ranges from 80 to 120 of the values of reference where 100 is the value according to each table 7 5 OTHER VALUES OF REFERENCE Based on Separ and Ceca references the spirometer has the following references Knudson Crapo Zapletal Morris Austria Gutierrez Chili Castro Brazil Polgar Weng Hankinson NHNES IIT Perez Padilla Mexico A J Cruz Mexico Golshan Iran DATOSPIR MICRO User s Manual 8 UPKEEP PREVENTATIVE AND CORRECTIVE MAINTENANCE 9An29J40 pue 4 8 4 5 DATOSPIR MICRO User s Manual 216 Like any equipment particularly if for medical applications the DATOSPIR MI CRO spirometer requires upkeep and maintenance aimed firstly at the safety of patients operators and the environment and secondly at ensuring the reliabili
27. Appendix 1 Electromagnetic Compatibility DATOSPIR MICRO User s Manual 226 5 sy DATOSPIR MICRO User s Manual 227 pope y m APPENDIX 2 COMPLI ANCE WI TH THE DATA PROTECTI ON ACT LOPD PY 32 4 993 z xipueddy S be med DATOSPIR MICRO User s Manual 228 COMPLIANCE WITH THE DATA PROTECTION ACT DIRECTIVE 95 46 EC Requirements specifically affecting the use of the DATOSPIR MICRO Spirometer This section seeks to ensure user compliance with the current data protection legislation in relation to the use of this equipment A brief description is given as to how the DATOSPIR MICRO Spirometer must be handled to comply with the requirements of this act IMPORTANT WARNI NG e According to current legislation the user of this equipment is the only party responsible for saving and processing the details of his patients according to the Law e Observance of the recommendations included in this section under no circumstances guarantees the full adaptation of the user s activity to the data protection regulation Configuration of the DATOSPIR MICRO Protection DATOSPI R spirometer has an equipment protection option that uses a password or pin This option is user configurable and seeks to prevent access by unauthorised people to the equipment and more specifically to the
28. Chapter 2 Model A Operating FS SI DATOSPIR MICRO User s Manual to see the values of the following variables No Pulses 0150 Turbine Fact 200 B OK 4V OK OK 26 C EQUIPMENT CHECK 3 LCD to test the LCD using a Bar test a bar is drawn alternately on the top and bottom line of the LCD Contrast scan EQUIPMENT CHECK 4 CPU to check the CPU 1 Calculates the flash checksum The top line indicates the current direction and the bottom line the checksum 0x300000 Chk Flash 0x59D9 DATOSPIR MICRO User s Manual 81 2 Calculates the bios checksum 0x20000 Chk Bios 0xBA47 3 Tests the internal RAM successively writing and reading the value 0x55 in the internal RAM The top line indicates the current direction and the bottom line the number of errors in the write read process OxFFEFOO Err CPU Ram 0 4 Tests the external RAM the same process as for the internal 81 000 Err Ext 0 EQUIPMENT CHECK 5 Auto On Off to check that the automatic on and off of the equipment works properly On selecting this option the equipment switches off and on automatically after 5 seconds jepoyw Chapter 2 Model A Operating FT ST DATOSPIR MICRO User s Manual 82 EQUIPMENT CONFIGURATION Select the option MAINTENANCE 4 Config Equip This option allows for diffe
29. MODULO PULSIOXIMETRIA XPOD XPOD PULSEOXIMETRY MODULE e SENSOR PULSIOXIMETRIA PINZA SPO2 ARTICULATED PULSE OXIMETRY 5 SENSOR M DULO BLUETOOTH BLUETOOTH MODULE ADAPTADOR BLUETOOTH BLUETOOTH ADAPTER INSTRUCCIONES ADAPTADOR ADAPTER INSTRUCTIONS OPCI N FIRMWARE BRONCODILATACION BRONCHODILATION FIRMWARE OPTION OPCI N FIRMWARE DIAGNOSTICO DIAGNOSTIC FIRMWARE OPTION OPCI N FIRMWARE BASE DATOS 1000 PRUEBAS 1000 TEST DATA BASE FIRMWARE OPTION CARGADOR 4 PILAS NiMh CHARGER 4 BATTERY NiMh 57 DATOSPIR MICRO User s Manual 19 WARNING According to the different regulations particularly the 93 42 EEC Medical Device Directive electromedical devices should be verified and or calibrated regularly to ensure reliable functions and the safety of patients users and the environment As well as the routine DATOSPIR MICRO spirometer calibrations its safety systems adjustments and functions etc should undergo a general annual service and under no circumstances exceed an eighteen month period without having been serviced These checks should also be made whenever the equipment is thought to be working incorrectly These checks must be carried out by the manufacturer or by skilled technical personnel authorised by SIBEL S A according to the manufacturer s SI BEL S A Verification and Adjustment Procedures All accessories and spare parts etc must be originals and are to be requested from the man
30. UNE EN 13826 2004 Bluetooth Module Compliance with Standard 2 0 Class II CE and FCC Certificate Power supply e 1 5 V battery alkaline recommended or 1 2 NiMh battery recommended gt 2200mAh Power Below 400 mW Size e 153 5x80x52 mm Weight e 250g Equipment lifetime e 10 years suone 2iji2eds 5 Chapter 5 Technical Specifications S be nmed DATOSPIR MICRO User s Manual Sibel med DATOSPIR MICRO User s Manual 201 6 OPERATING PRINCIPLES 9 4 4 5 DATOSPIR MICRO User s Manual 202 The DATOSPIR MICRO spirometer is a piece of equipment that acquires physical signals and processes the information provided by the signal related to the pulmonary function For processing purposes physical must be changed to electrical The units responsible for this change are called transducers The DATOSPIR MICRO has a Turbine type transducer The turbine transducer performs transduction in two stages The volume to be measured crosses the turbine and prints its rotation that is proportional to that volume This rotation is detected by the interrupting of a beam of infrared light the sensor of which converts the light received into a digital type electrical signal 6 1 TURBINE The turbine is axial with two stators in the form of a propeller and a rotor made up of a flat rectangular blade The
31. Ut 30 dip in Ut for 25 cycles 95 Ut 55 dip in Ut for 5 seconds Not applicable Datospir Micro works with batteries DC USB power Power frequency 50 60 Hz magnetic field EN IEC 61000 4 8 3 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial of hospital environment 213 0 132 13 T Xipueddy Sib elmed DATOSPIR MICRO User s Manual Guidance and manufacturer s declaration electromagnetic immunity Datospir Micro is intended for use in the electromagnetic environment specified below The costumer or the user of Datospir Micro should assure that it is used in such an environment Immunity test EN IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF EN IEC 61000 4 6 Radiated RF EN IEC 61000 4 3 3 Vrms 150KHz to 80 MHz outside ISM bands 3 V m 80 MHz to 2 5 GHz 3 Vrms 3 V m Portable and mobile RF communications equipment should be used no closer to any part of Datospir Micro including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 4 80 MHz to 800 MHz d E P 80 MHz to 800 MHz d 800 MHz to 2 5 GHz where P is the maximum output powe
32. available in a series of models depending on the different options included as indicated in detail below 5 DATOSPIR MICRO User s Manual 1 2 PRIOR OBSERVATIONS This User Manual is for all models and options of the DATOSPIR MICRO spirometer Therefore only specific options or functions of the model available will be applicable in each case This spirometer has been manufactured using solid state professional components under strict quality controls However accidents may occur during the transportation or storage of the equipment and it is therefore wise to initially check its condition and that of its accessories before installing them WARNING SHOULD YOU DETECT ANY DAMAGE TO THE PACKAGING CONTACT THE HAULIER AGENCY AND DISTRIBUTOR IMMEDIATELY BEFORE STARTING THE INSTALLATION PACKAGING AND BAGS ETC MUST NOT BE DISPOSED OF UNTIL THE CORRECT WORKING ORDER OF THE EQUI PMENT HAS BEEN FULLY VERIFIED Chapter 1 Instructions for Use and nstallation 5 DATOSPIR MICRO User s Manual 1 3 DATOSPIR MICRO SPIROMETER MODELS The DATOSPIR MICRO spirometer series is made up of the following models depending on the options included DATOSPIR MICRO A DATOSPIR MICRO DATOSPIR MICRO C The enclosed tables show the basic standard features of each model and all other optional parts and functions A model can be upgraded at any time by adding the corresponding parts To do so please c
33. being carried out as his cooperation is vital for it to be completed correctly 4 The maximum time allowed for the manoeuvre is 45 seconds The equipment saves a maximum of five manoeuvres ordered according to the VC value where M1 is the best VC and M3 the worst 5 To measure the ERV and TV parameters correctly each manoeuvre must have at least four respiratory cycles SSN S 6e med DATOSPIR MICRO User s Manual 6 The registering of parameters and graphs is as shown below Sibelmed DATOSPIR MICRO SIBEL S A ROSSELLO 500 08026 BARCELONA PULMONARY FUNCTION TEST Code Name Sex Temp C References Reason Origin Technician Bios Ver VC REPORT PARAMETER ERV Comments DATOSPIR MICRO 0000000001 Date 03 22 2006 Time 17 52 26 Height cm 174 Wt Kg 68 26 Pres mmHg 760 Humidity 60 Smok I 0 SEPAR Ethnic 5 100 5115 1 00 Prog Ver 5115 1 00 MANOEUVRE No 1 1 es 193deu5 S be med DATOSPIR MICRO User s Manual 132 3 6 MAXI MUM VOLUNTARY VENTILATI ON MVV TEST PROCEDURE The procedure to carry out the Maximum Voluntary Ventilation test is similar to that described in section 3 4 FORCED VITAL CAPACITY FVC PROCEDURE with the following variations 1 Access the MVV test by pressing the key v from the main screen and perform a m
34. by more than 200 ml of FVC or FEV1 The best effort cannot only be determined by merely inspecting the spirometric curve but also by checking the measurements to determine the maximum values The independent selection of FVC and FEV1 sometimes causes greater variability as factors such as learning tiredness or bronchial spasms caused by expiration come into play The best FEV1 does not have to be rejected when the manoeuvre from which it originates has ended prematurely However FEF25 75 is influenced by the vital capacity of the curve chosen Falsely high values may be recorded if a manoeuvre with a shortened or lower vital capacity than the real vital capacity of the patient has been chosen It seems that the most practical criterion is to choose the manoeuvre containing the FVC and FEV1 with the highest sum among the three chosen for calculation 7 2 CALI BRATI ONS As well as the calibration procedures included by the manufacturer in the appliance to quickly check the working order of the basic pneumotachometer circuits and mechanisms it must be possible to check the appliance through external signals These signals must be as similar as possible in terms of flows volumes and times to the biological signal for which the instruments were designed i e forced expiration This is not always possible S be med DATOSPIR MICRO User s Manual 210 although at least one of the elements of the biological signal the volume or the flow m
35. can be modified if required CAL DATA Pres mmHg 10 Press gt the following screen will appear CALIBRATION Start Calibra 11 Press gt again start emptying the syringe for two or more consecutive cycles one cycle is equal to emptying and filling the syringe When emptying and filling the syringe piston must move all the volume used as a reference If this is not done correctly the equipment will detect it as incorrect manoeuvres Furthermore this process should be completed in a regular and uniform manner without causing flow rates that are too high or too low Where this is not the case you will be told to repeat the manoeuvre The time of each cycle emptying plus filling the syringe most be no less than four seconds and no more than ten The equipment waits for 30 seconds for calibration to begin The process must be restarted if this time is exceeded During calibration the second line of the screen will show a bar movement of which is proportional to the volumen applied On completion the following screen or similar will appear if the process was correct Sibel med DATOSPIR MICRO User s Manual 71 CALIBRATED Ve Vi 3 001 lt 2 Calibrated volumes 12 Once the DATOSPIR MICRO has been calibrated press gt and the screen will return to the Start Calibration option CALIBRATION REGISTER The spirometer has a register containing the expiratory and inspiratory factors o
36. cooperation is vital for it to be completed correctly Review Chapter 7 SPIROMETRY TECHNI QUE Patients can carry out the spirometry manoeuvres in two different Ways The first consists in starting the manoeuvre with FORCED EXPI RATI ON followed by FORCED I NSPI RATI ON if required In the second way the patient breaths normally through the turbine and when indicated by the technician takes a deep breath filling completely his lungs and then performs a FORCED EXPI RATI ON followed by FORCED I NSPI RATI ON if required 3 Inform the patient of how to hold the equipment when using the spirometer taking care not to press any key and fitting the nose clip SSI z S be rmed DATOSPIR MICRO User s Manual 117 4 Press the key and wait until a flashing arrow appears on the screen Ihen start the spirometric manoeuvre The manoeuvre underway can be ended at any time by pressing the key The equipment is held so that the doctor can see the screen while the patient is carrying out the tests indicates the current manoeuvre indicates the selected manoeuvre the best is selected by default M1 S be med DATOSPIR MICRO User s Manual 118 At the end of the manoeuvre one or more of the Warnings if enabled in the Customisation Programme may appear to warn whether the manoeuvre is compliant with ATS ERS Criteria According to the indication the manoeuvre has not been carried out a
37. corresponds to a volume of 6 litres DATOSPIR MICRO User s Manual At the end of the manoeuvre one or more of the Warnings if enabled in the Customisation Programme may appear to warn that the manoeuvre is not compliant with ATS ERS Criteria An indication is given to inform that the manoeuvre has not been carried out according to one of the following ATS ERS criteria ET Indicates that spiration has not completed satisfactorily as the variation on volume in the last second of the manoeuvre was above 25 ml or the manoeuvre has lasted less than 6 seconds in patients aged over 10 and more or less than 3 seconds in patients aged 10 or less EX Indicates that the start of expiration was not satisfactory as the extrapolated volume is above 5 of the FVC or 0 15 litres The ATS ERS recommends it be less than 5 the FVC or 0 15 litres whichever is highest The technician performing the spirometry may where considered appropriate disable these warnings in the Customisation Programme In this case they will also be removed from the printed report This disabling is only at display level The warnings are still taken into account when ordering the manoeuvres 5 Press the gt key if the Warnings are enabled The following screen or similar will be shown depending on the parameters selected in the Customisation Programme 5 DATOSPIR MICRO User s Manual 46 X XX
38. described above Once the manoeuvre to be saved on the database has been selected on the test screen press the key The following screen will appear Press the key The following message will appear indicating that the manoeuvre has been saved 4 5 5 S be med DATOSPIR MICRO User s Manual PRINTING THE FVC The DATOSPIR spirometer can print any manoeuvre made using an external printer The manoeuvre selected by default is the best M1 If you want to produce a report on another it must first be selected Check that the printer is ready and connected Select the manoeuvre to be printed flashing from the test screen and press The best M1 is recommended The following screen will then appear to indicate the printing process REPORT 1 The printer will present a report similar to the one shown on the next page This will include the parameters and graphs corresponding to the selected curve If you do not want graphs certain parameters the diagnosis and or ATS ERS warnings to appear disable them as described in section 3 2 If you want a global printout of the report including the FVC VC and MVV tests made on a patient follow the steps described in the General Report Printout section S Ge med DATOSPIR MICRO User s Manual Sibelme DATOSPIR MICRO SIBEL S A ROSSELLO 500 08026 BARCELONA PULMONARY FUNCTION TEST DATOSPIR MICRO Code 000000
39. option restores the original customisation if it has been modified either voluntarily or by accident In general this configureation will correspond to that most often used 1 Retrieve Standard The configuration saved can be loaded as standard 2 Modify Standard The configuration to date can be saved for use as standard BATTERY CUSTOMISATION The DATOSPIR works with two types of battery alkaline or NiMh independent to the battery selected in this section This selection only affects the calculation made inside the equipment to indicate the battery levels LANGUAGE CUSTOMI SATI ON This option allows for the equipment language to be chosen SET CLOCK This option sets the time and the date of the clock inside the equipment 6 DATOSPIR MICRO User s Manual 37 EQUIPMENT PROTECTION CUSTOMISATION This allows you to change the PIN required to start the equipment if the protection option is enabled and to enable or disable equipment protection The following screens will appear successively CHANGE PIN Current Pin 0000 CHANGE PIN Pin Enabled Yes CHANGE PIN New 1 0000 CHANGE PIN New 2 0000 To enable protection select YES on the Pin Enabled screen and enter the PIN in the New 1 and 2 screens To change the PIN you must enter the current one If an erroneous PIN is entered three times the equipment will lock and will switch off See the following section 2 3 EQUIP
40. opto electronic rotary sensor that is detachable for cleaning and sterilisation Rotation is made on saphire bearings for high reproduceability and duration suone 2ii2eds 93d eu Chapter 5 Technical Specifications S be med DATOSPIR MICRO User s Manual RANGES AND MEASUREMENTS Turbine Measurement Scale BTPS Flow 1 5 0 to 16 Volume 1 to 10 Dynamic flow resistance kPa l s lt 0 122 to 14 1 5 Precision of measurements BTPS Volume the highest 3 or 50 ml Flow the highest 596 or 150 ml s Time related precision 0 5 Resolution in volume ml lt 6 Sampling frequency Hz 25 Turbine lifetime 600 disinfections or 3 years SpO and Pulse SpO 96 Pulse BPM Measurement Range 0 100 0 250 Resolution 1 1 Precision 70 to 100 2 1 3 the highest lt 70 Not specified 5 3 MICRO CONTROLLER System micro controller Hitachi H8S2144 6 DATOSPIR MICRO User s Manual Volume accumulation time e Five FVC curves with a maximum of 25 seconds each e Five VC curves with a maximum of 45 seconds each Five MVV curves with a maximum of 15 seconds each Start FVC expiration e Using the retrograde extrapolation method End FVC expiration When the volume accumulated in the last second is below 0 025 litres FVC test selection According to the criterion of the maximum sum of FVC FEV1 or depending on the oper
41. s Manual 3 8 PULSE OXIMETRY TEST PROCEDURE Occasional Oxygen Saturation SpO and Pulse Rate PR tests or long term studies particularly aimed at controlling patients during sleep any other situation desaturation measurement etc can be performed During long term studies it is wise to secure the sensor to the patient s finger using a plaster as shown in the following figure The plaster must not place too much pressure on the finger so as not to modify perfusion in the finger PULSE OXIMETRY CUSTOMISATION The SpO module is an option included the DATOSPIR MICRO Each user should customise it to suit their needs To access the pulse oximetry customisation menu start the DATOSPIR MICRO using the key Press and DATOSPIR MICRO User s Manual 139 CUST SC Exits this screen and goes back to the previous one Average SpO configuration and beeping sound Parameter configuration Trends graph Press and the following screen will appear Average Beer You Configure the average SpO Enable the beeping sound signal coinciding with each pulse 5 DATOSPIR MICRO User s Manual Press and the following screen will appear SP02 ITor Bot Ref BPM eBoteRefd E E Soreen Time mies This screen allows you to customise the different pulse oximetry parameters Top Top and bottom
42. standard or optionally to an external printer where this has been previously selected in the Customisation option In this case following the instructions of the corresponding printer 5 DATOSPIR MICRO User s Manual 1 6 OPERATI NG MODES The DATOSPIR MI CRO spirometer has two operating modes e HOME Mode HOSPITAL Mode Each one is selected from the main screen HOME MODE This operating mode means that the DATOSPI R MI CRO can be programmed to control asthmatic patients at home See section 2 12 3 13 HOME MODE OPERATI ON The equipment is very simple and easy to handle presenting the measured value of PEF FEV1 or FVC in a colour range of Green Yellow and Red semaphore as programmed Spirometer operations by patients at home are saved in an internal database and subsequently transferred to the PC database for data analysis and storage HOSPITAL MODE This option means that the DATOSPI R MICRO can be used asa sophisticated spirometer with the following functions Spirometry Patient Details Reference Age Weight Height Sex Index Smoker Atmospheric Conditions Temperature Pressure Humidity Tests FVC VC MVV Bronchial Dilation Report Chapter 1 Instructions for Use and nstallation 5 DATOSPIR MICRO User s Manual Customisation selectable options Spirometry References Parameters Graphs Diagnosis Dilation Modes Warning
43. test must always be validated by the specialist Miller Diagnosis This presents the following information NORMAL RESTRICTIVE OBSTRUCTIVE or COMBINED according to the criteria of the following chart S be med DATOSPIR MICRO User s Manual 122 MILLER QUADRANT 128 T Restrictive Normal 198 20 Combined Obste Snider Kory amp Lyons Diagnosis This is based on the following criteria If FVC gt 80 of the FVC Reference and FEV1 gt 80 of the FEV1 Reference Values in the range of reference Normal Diagnosis If FEV1 FVC lt FEV1 FVC Reference and FEV1 80 of the FEV1 Reference Obstructive ventilatory defect FEV1 80 Slight 1 lt 65 Moderate FEV1 lt 50 Intense FEV1 lt 35 Very Intense If FEV1 FVC lt FEV1 FVC Reference and FVC lt 80 of the FVC Reference Non obstructive ventilatory defect FVC lt 80 Slight FVC lt 65 Moderate FVC lt 50 Intense FVC lt 35 Very Intense If FEV1 FVC lt FEV1 FVC Reference and FVC gt 80 of the FVC Reference Mixed ventilatory defect is suspected Sibelmed DATOSPIR MICRO User s Manual 123 If FEV1 FVC lt FEV1 FVC Reference and FEV1 gt 80 of the FEV1 Reference Mixed ventilatory defect is suspected If the POST bronchial dilation test is carried out and the FEV1 POST exceeds the base FEV1 or PRE by 15 There is a positive response to the bronchial dilating drug To see the diagnosis
44. to be used can be selected This is only at display level or for the report All the parameters are saved to the database and can be enabled at any time 3 Graphics The graphics can be saved to the database 4 Diagnosis The type of diagnosis can be selected Miller or Snider Kory amp Lyons helmed DATOSPIR MICRO User s Manual 35 5 Dilation modes The comparison mode can be selected in POST bronchial dilation 6 Warnings The printing of Non conformity warnings regarding the operations with ATS ERS criteria can be selected CUSTOMISATION OF THE HOME MODE In this option it is possible to configure the DATOSPIR MICRO for use in home mode See Section 2 12 HOME MODE OPERATIONS PRINTER CUSTOMISATION In this option you can choose if you want to print in black and white or color The Datospir Micro works only with HP PCL printers To be able to print from the equipment you must 1 Select the type of printer connected to the equipment once this has been done you will not have to repeat this step unless the printer is changed 2 Connect the equipment to the external printer using the Mini USB cable code 305 600 040 included depending on model 3 Switch the printer on Chapter 2 Model A Operating Sibel med DATOSPIR MICRO User s Manual 36 STANDARD CONFIGURATION This option memorises a user defined customisation programme status to retrieve it at any time globally and automatically This
45. 0001 Date 04 06 2006 Time 11 34 Name r Sex Male 27 Height cm 174 Wt Kg 68 Temp C 26 Pres mmHg 760 Humidity 60 Smok I 0 References SEPAR Ethnic 100 Reason Origin Technician 4 5115AB 1 00 Prog Ver 5115AF 1 00 FVC REPORT MANOEUVRE No 1 1 PARAMETER OBS REF 3 Best FVC 2 5 99 5 35 112 Best FEV1 1 4 26 4 27 100 FVC 1 5 99 5 35 112 FEV1 1 4 26 4 27 100 FEV1 FVC 70 121 80 44 88 PEF 1 5 6 50 10 11 64 50 1 5 3 78 5 52 68 FEF25 75 1 8 3 42 4 50 76 FEV1 FEVO 5 1 55 1 45 107 FEV1 PEF 10 93 6 64 165 pue SjJapow 5 DATOSPIR MICRO User s Manual DELETI NG A MANOEUVRE MADE The DATOSPIR MICRO spirometer deletes any manoeuvre made whether it is because you are doubtful as to whether its values are correct due to a defective performance which may distort the results or for any other reason The manoeuvre selected by default is the best M1 If you want to delete another it must first be selected Select the manoeuvre to be deleted flashing from the test screen and press le The following message will appear MANOEUVRE WILL BE DELETED ARE YOU SURE Press the key to delete the manoeuvre Then the following message will appear to indicate that the manoeuvre has been deleted Sibelmed DATOSPIR MICRO User s Manual 129 OTHER TESTS ON THE SAME PATIENT You ca
46. 2 Connect the equipment and the PC by series port USB or Bluetooth 3 Run the previously installed W 20 Spirometry Software making sure that the DATOSPIR MICRO is selected in Configuration Links and access the Configuration Utilities Download Data option The transferred information is saved in the DATA directory of the application in the files STATUS CSV Contains the errors detected CALI BRA CSV Contains the calibration data CONFI G CSV Contains the equipment customisation PRUEBAS CSV Contains the database tests GRAFXxx CSV Contains the graphs in Flow Time mode The files from the previous transfer are renamed with the extension OLD S be med DATOSPIR MICRO User s Manual 186 4 If you want to view the information of any of the files load them using MICROSOFT EXCEL 5 Load the files to your normal e mail programme and send to the SIBEL S A AFTER SALES SERVICE or your Distributor who will analyse them and contact you to solve the problem presented If you do not have e mail you can print the data and send it by FAX 4 2 PATIENT TEST MANAGEMENT IN THE PC If you want ot view print manage and or save the tests in the PC you must have W 20 Spirometry Software The process to follow is 1 Save the tests required in the equipment s internal Database 2 Install the W 20 Spirometry Software as detailed in its User s Manual 3 Load the Database data from the PC using the W 20 Software BATCH option
47. 22 1 5 INSTALLATION AND START UP DATOSPIR MICRO INSTALLATION The DATOSPIR MI CRO spirometer is CLASS according to the criteria of the 93 42 EEC European Medical Device Directive and in line with the type of protection against electric shocks established by the EN60601 1 standard the equipment is rated as CLASS type B Batteries The DATOSPI R MI CRO spirometer works as standard using two AA 1 5 V batteries or optionally using rechargeable NiMh batteries AA 1 2 V type WARNI NG Never try to recharge alkaline batteries This would cause damage to both the batteries and the charger In both cases the autonomy will depend on the quality of the batteries used In Model A 1 5 V alkaline batteries or with 2400 mAh rechargeable batteries will last for approximately 40 hours Autonomy may drop by 50 when working via Bluetooth and USB connection to the PC will not use any batteries given that the equipment is powered through the PC s USB port In models B and C battery life will be smaller than model A It will be directly affected by time that Lcd Backlight is on The charging time for rechargeable NiMh batteries will depend on the charger used To save power the equipment includes an auto switch off system that turns the equipment off when not touched for 5 minutes except in main spirometry and pulsioximetry screens In this case the data on the screen is lost and the normal process must be followed to restart the
48. 3deu 5 5 DATOSPIR MICRO User s Manual 208 7 1 PROCEDURE The following is an extract from the STANDARD FOR FORCED SPI ROMETRY SEPAR Recommendations 1 Forced spirometry will be performed with the patient seated upright with the nose occluded by clips The technician will rest his hand on the patient s shoulder to prevent him from leaning forwards during expiration The mouthpiece will keep its shape to prevent the hole from being reduced due to biting during forced expiration Soft mouthpieces must be shortened to increase their consistency Spirometry always involves a minimum of three forced expiration manoeuvres and a maximum of eight when not considered suitable Exceeding this limit leads to the needless tiring of the patient and a loss of the technician s time To assess the spirometry performed lying down remember that under these conditions the data obtained is approximately 1096 below those obtained when the patient is seated In patients with a diaphragmatic or neuromuscular pathology the difference between the two positions may be up to 40 60 making the observation a useful piece of data to assess the repercussions of this pathology When working with a pneumotachometer the manoeuvre may be exclusively reduced to maximum expiration from the maximum inspiration position The correction of a manoeuvre will be judged by its start its progress and its completion observing the patient and the
49. AYING RESULTS Press the parameter area The data on the selected manoeuvre will be displayed M1 by default ESC ct Go back to the previous screen Change manoeuvre Display the diagnosis of the selected manoeuvre iJ ES Print the report on the selected manoeuvre umet Save the selected manoeuvre in the database or v Display the remaining parameters if selected The screen displays the values of Reference the Observed values and the between both parameters selected in the Customisation Programme If an appears after the REF test this means that the values of reference have been extrapolated DATOSPIR MICRO User s Manual 121 Italso displays The best FVC and FEV1 values that may correspond to different manoeuvres Ethnic factor if not used this must be 100 Warnings of Non Compliance with ATS ERS criteria for each manoeuvre WARNING As indicated the BEST manoeuvre is set at M1 Therefore use M1 to display the diagnosis to print the report or to save the manoeuvre for the POST bronchial dilation or for the Internal Database except where the user considers it wise to choose a different one TYPE OF DIAGNOSIS The DATOSPIR MICRO spirometer has two types of diagnosis that can be selected in the Customisation Programme NOTE If you do not agree with these two criteria do not use them as a reference The diagnosis and the results of the
50. Between 50 and 230 cm Kg Between 15 and 200 Kg Press to configure the semaphore and the alarms Select the parameter of reference for the manoeuvres and ress S be med DATOSPIR MICRO User s Manual The value of REFERENCE will then appear depending on the age weight etc of the patient and the tables enabled in the Customisation programme This value can be changed by the specialist for patients who under controlled asthma conditions have a significant deviation with regard to the reference standard The value programmed will be equivalent to 100 in the subsequent control Select the value where necessary REFERENCE ALLE 2 3 4 5 6 7 8 9 The levels must be defined in percentages in relation to the value previously selected from among the different semaphore indicators The standard levels are GREEN Zone Between 100 and 80 Normal YELLOW Zone Between 80 50 Precaution RED Zone Between 50 and 0 Warning Select the level where necessary SEMAPHORE LEVELS Min Level X1 Level Sibel med DATOSPIR MICRO User s Manual The alarms are a reminder for the patient as the test can be taken at any time despite it being different to the time programmed and the time it is taken is recorded DAILY TESTS Select the days of the week on which the tests are to be performed TEST DAYS Thurzdas Friday Saturday Sunday S be med DATOSPI
51. Bot levels fro displaying SpO2 and PR trends Reference Ref line level for both channels On screen display time between 5s and 29m 595 ENTERI NG TEST DATA Start the DATOSPI R MI CRO using the key wait for the main screen to appear and press the key The following screen or similar will appear depending on the mode selected numeric or alphanumeric DATOSPIR MICRO User s Manual Cod 0123456799 Voss C The meaning of each field is as follows Cod Code 10 character numeric or alphanumeric field depending on the customised option corresponding to the patient code 5 Sex Between male and female Yrs Age Number corresponding to the age between 4 and 100 cm Height Height in cm between 50 and 230 kg Weight Weight in kg between 15 and 200 Enter the patient s details and press the key to go to the test screen PERFOMI NG PULSE OXI METRY TESTS On accessing this screen the pulse oximeter automatically begins to take samples The Oxygen Saturation 5 0 and Pulse Rate PR values are displayed The top of the screen indicates the signal time trends saved in the memory to date S be med DATOSPIR MICRO User s Manual 9123456799 17 45 PULSE SIGNAL ON MEMORY 00 00 00 s l 96 112 E Exits this screen and goes back to the previous one Average SpO configuration and beeping sound Deletes the study from the memor
52. DATOSPIR MICRO SPIROMETER USER MANUAL Sibelmed 511 00 02 REV 1 04 gt NE eS A S be med DATOSPIR MICRO User s Manual SIBEL GROUP is a group of Spanish manufacturers made up of SI BEL S A SI BELMED MEDITEL INGENIER A MEDICA BITMED and APARATOS Y SISTEMAS DE MEDIDA S A ASIMED The above mentioned group comprises companies that without losing their own identity collaborate closely to manufacture and commercialise their products with one sole aim that is to offer their respective clients a wider range of quality products manufactured in Spain as well as an improved service As you are aware SIBEL S A designs and manufactures medical equipment under the trademark SI BELMED mainly in the following areas RESPI RATORY OTOLARYNGOLOGY AND SLEEP PATHOLOGY The company MEDITEL INGENIERIA MEDICA S L designs and manufactures products for electromedicine and sport under the trademark BI TMED ts main business areas are ELECTROENCEPHALOGRAPHS POLYGRAPHS POLYSOMNOGRAPHS AND PORTABLE SYSTEMS FOR THE STUDY OF FOOTSUPPORT The company APARATOS Y SISTEMAS DE MEDIDA S A designs and manufactures measuring products under the trademark ASI MED such as ELECTRONI CAND MECHANI CAL PERSON AND BABY WEI GHI NG SCALES FLOOR BED CHAIR AND DI ET SCALES SI BEL S A Rossell 500 08026 Barcelona Spain National Sales Tel 93 436 00 08 e mail comercial sibelmed com International Sales Tel 34 93 436 00
53. EV1 lt 35 Very Intense If FEV1 FVC lt FEV1 FVC Reference and FVC lt 80 of the FVC Reference Non obstructive ventilatory disturbance FVC lt 80 Slight FVC lt 65 Moderate FVC lt 50 Intense FVC lt 35 Very Intense If FEV1 FVC lt FEV1 FVC Reference and FVC gt 80 of the FVC Reference Mixed ventilatory disturbance is suspected If FEV1 FVC lt FEV1 FVC Reference FEV1 gt 80 of the FEV1 Reference Mixed ventilatory disturbance is suspected If the POST bronchial dilation test is carried out and the FEV1 POST exceeds the base FEV1 or PRE by 1596 There is a positive response to the bronchial dilating drug MEMORISI NG FVC TESTS Memorising a test in the I nternal Database The DATOSPIR MICRO spirometer has an Internal Database that can save different tests to be subsequently transferred to a PC Database using W20 Spirometry Software This base may be of the L or depending on its capacity The process is similar to that described in the DISPLAYING RESULTS section although previously selecting the option DATOSPIR MICRO User s Manual 51 FVC TEST 4 Save DB Press the gt key a similar screen to the following will appear depending on the number of manoeuvres made SAVE DB Mi M2 M3 M4 M5 The manoeuvres are ordered according to ATS ERS criteria with 1 the best and 5 the worst The manoeuvre between brackets M3 indicates the pos
54. FORCED VITAL CAPACITY TEST PROCEDURE 112 3 5 SLOW VITAL CAPACITY TEST PROCEDURE 130 3 6 MAXIMUM VOLUNTARY VENTI LATI ON MVV TEST PROCEDURE Ez Ra 132 3 7 POSTBRONCHI AL DI LATOR SPI ROMETRY PROCEDURE 134 3 8 PULSE OXI METRY TEST 138 3 9 CALIBRATION PROCEDURE 149 3 10 INTERNAL DATABASE 155 3 11 MAINTENANCE PROGRAMME 162 3 12 UPDATI NG NTERNAL SOFTWARE 168 3 13 HOME MODE OPERATION 172 4 COMMUNICATIONS SYSTEM 183 S be mecd Manual de Uso DATOSPIR MICRO 11 4 1 TRANSFERRING EQUIPMENT CHEQUE DATA DATABASE DATA 184 4 2 PATIENT TEST MANAGEMENT IN THE PC 186 4 3 EXPORTING TESTS TO OTHER SYSTEMS 187 4 4 SPIROMETRY SOFTWARE W 20 188 5 TECHNICAL SPECIFICATIONS 189 5 1 TYPES OF TEST FUNCTIONS AND PARAMETERS 190 5 2 MEASURING SYSTEM 195 5 3 MICRO
55. FVC XX XX Select the value where necessary and press gt DATOSPIR MICRO User s Manual 91 The levels must be defined in percentages in relation to the value previously selected from among the different semaphore indicators The standard levels are GREEN Zone Between 100 and 80 Normal YELLOW Zone Between 80 and 50 Precaution RED Zone Between 50 and 0 Warning SEMAPHORE LEVELS Min xxx Max Select the level where necessary and press gt 6 The alarms a reminder for the patient as the test can be taken at any time despite it being different to the time programmed and the time it is taken is recorded DAILY TESTS None one two or three No of Tests x daily alarms for the test TEST 1 XX XX XX Time of the ist test TEST 2 XX XX XX Time of the 2nd test TEST 3 XX XX XX Time of the 3rd test 5 DATOSPIR MICRO User s Manual TEST DAYS Days of the week when MoTuWeThuFrSaSu the tests are taken Home mode is now configured so that you simply have to access the following option from the main screen to activate it MAIN MENU 6 Hospital mode Shows the current mode Press the gt key to change mode and switch the equipment off ACQUISITION OF SPIROMETRIC TESTS Once the equipment has been configured by the specialist the test acquisition process can begin The storage capacity is 150 or 1000 tests depending on the database L or H
56. HE FVC The DATOSPIR CRO spirometer can print any manoeuvre made using an external printer The process is similar to that described in the previous section but previously selecting the option FVC TEST 6 Report Press the gt key similar screen to the following will appear REPORT M1 M2 Check that the printer is ready and connected Select the manoeuvre to print flashng text and press gt The best M1 is recommended JePOW Chapter 2 Model A Operating DATOSPIR MICRO User s Manual The printer will present a report similar to the following DATOSPIR MICRO SIBEL S A ROSSELLO 500 08026 BARCELONA PULMONARY FUNCTION TEST DATOSPIR MICRO Code 0000000001 Date 04 06 2006 Time 11 34 Name Sex Male 27 Height cm 174 Wt Kg 68 Temp 26 Pres mmHg 760 Humidity 60 Smok I 0 References SEPAR Ethnic 100 Reason Origin Technician Bios Ver 5115AB 1 00 Prog Ver 5115AF 1 00 FVC REPORT MANOEUVRE No 1 1 PARAMETER OBS REF 3 Best FVC ft 5 99 5 35 112 Best FEV1 1 4 26 4 27 100 FVC 5 99 5 35 112 FEV1 dd 4 26 4 27 100 FEV1 FVC 75 27 80 44 88 PEF 1 5 6 50 10 11 64 MEF50 1 8 3 78 5 52 68 FEF25 75 1 8 3 42 4 50 76 FEV1 FEVO 5 1 55 1 45 107 FEV1 PEF 10 93 6 64 165 DATOSPIR MICRO User s Manual 55 This will include the parameters a
57. I NDI CATI ONS An analysis of the results of a spirometry tests is not enough in itself to give a correct diagnosis of the patient s clinical condition SSI n 13727 22 07 MB DATOSPIR MICRO User s Manual The patient s records and any tests that the doctor believes necessary must therefore also be considered A doctor must interpret the tests and any treatment provided as a result The patient s symptoms must be taken into account by medical staff before any spirometric test is undertaken Acceptability of a test is the responsibility of the medical staff The spirometer must not be used when the validity of the results is likely to be jeopardised by external factors Patients to have suffered myocardial infarction during the past month are recommended not to take the test In patients with thoracic or abdominal pain oral or facial injuries stress or dementia of any kind the results may not be optimal and repeatable ELECTRICAL RISKS Dot NOT remove the equipment casing The device must only be serviced and repaired by skilled personnel The contact with voltage inside the system may cause serious injury Do NOT use damaged accessories Do NOT submerge the parts of the device in any liquid THIS MAY CAUSE ELECTRIC SHOCKS Consult the equipment cleaning method in Chapter 8 Section 8 1 UPKEEP PREVENTATIVE AND CORRECTIVE MAINTENANCE To ensure vital safety features under the EN 60601 1 1 standard only equip
58. Internal Software Transfer Tests on patients to a PC Export Tests on patients to other Management Systems Communications can be made through three different channels using the corresponding software RS232C Series standard USB standard Bluetooth optional To install USB and Bluetooth consult the W20 Spirometry Software User s Manual 4 1 TRANSFERRING EQUIPMENT CHEQUE DATA AND DATABASE DATA The DATOSPIR MICRO includes a programme that auto checks the working order of certain parts of the equipment displaying the information on the screen and saving it in an internal file The information available is Hardware check Software check Equipment customisation Calibration Registering FVC test with standard curve DATOSPIR MICRO User s Manual 185 If a problem is detected that the user is unable to solve the first alternative is to send the auto check information to the SIBEL S A After sales Service or to your distributor who will analyse it and assess the cause of the problem providing or proposing a suitable solution W20 Spirometry Software in demo mode or enabled is required to transfer this information The programme in demo mode is included as standard with the equipment The process to follow is 1 Start the DATOSPIR MICRO and select Maintenance from the Main screen Access the Equipment Check option and run all the suboptions following the instructions on the screen
59. MENT PROTECTION Sibelmed DATOSPIR MICRO User s Manual 38 2 3 EQUIPMENT PROTECTION If equipment protection has been enabled the following screen will appear when it is started ENTER PIN Pin 0000 Enter PIN If the PIN configured in Equipment protection customisation is entered access will be given to the DATOSPI R MICRO and the main screen will appear If an erroneous PIN is entered three times the equipment will lock and will switch off The following screen will appear when it is restarted UNLOCK CODE 00000000000000 Enter the unlock code PUK supplied on purchasing the equipment If the correct code is entered the DATOSPI R MI CRO will unlock and the main screen will appear From then on the equipment will return to its initial status Protection disabled and PIN 0000 If an erroneous code is entered the equipment will remain locked This prevents access to the equipment and more specifically to the private data it contains by unauthorised people 6 DATOSPIR MICRO User s Manual 39 2 4 FORCED VITAL CAPACITY TEST PROCEDURE The procedures to be completed to carry out the Forced Vital Capacity FVC slow Vital Capacity and Maximum Voluntary Ventilation tests are very similar Therefore only one detailed description will be given in this section ENTERING PATIENT PARAMETERS Start the DATOSPIR
60. MICRO using the key and wait for the following screen to appear MAIN MENU 1 Spirometry Press the gt key and the following will appear SPIROMETRY 1 FVC Press the gt key and the following will appear PATIENT DETAILS Code 0000000000 Enter the patient code between 0 and 9999999999 jepoyw 5 DATOSPIR MICRO User s Manual 40 Select the digits using the gt set the for each digit Press the gt key to to the next and so on in the remaining screens indicated PATIENT DETAILS Age years xx Between 4 and 100 PATIENT DETAILS Height cm xxx Between 50 and 230 cm PATIENT DETAILS Weight Kg xx Between 15 and 200 Kg PATIENT DETAILS Sex Man Between male and female PATIENT DETAILS I Smoker xx Between 0 and 200 packs a day per number of years PATIENT DETAILS Cig day xx Between 0 and 20 cigarettes PATIENT DETAILS Ethnic F xxx Between 80 and 120 The Smoker Index is the same as the number of cigarettes smoked a day divided by 20 and multiplied by the number of years smoking cigarettes day x years smoking 20 Sibelmed DATOSPIR MICRO User s Manual 41 The ethnic factor is used in areas without any parameters of reference that use some existing yet corrected in a certain percentage This factor MUST BE SET TO 100 I F NOT USED and can only be modified through the Customisat
61. ONA PULMONARY FUNCTION TEST DATOSPIR MICRO Code 0000000001 Date 04 06 2006 Time 11 34 Name Sex Male Age y 27 Height cm 174 Wt Kg 68 Temp C 26 Pres mmHg 760 Humidity 60 Smok I 0 References SEPAR Ethnic 100 Reason Origin Technician Bios Ver 5115AB 1 00 Prog Ver 5115AF 1 00 FVC REPORT MANOEUVRE No 1 1 PARAMETER PRE REF POST SP Best FVC HJ 5 00 5 35 93 5 99 18 Best FEV1 1 4 57 4 27 107 4 26 6 ET H 5 00 5 35 93 5 99 18 T 4 57 4 27 107 4 26 6 FEV1 FVC t 91 57 80 44 114 71 17 24 1 6 9 87 10 11 98 6 50 40 50 l s 6 16 5 52 112 3 78 47 FEF25 75 1 5 5 69 4 50 126 3 42 49 FEVI FEVO 5 1 30 1 45 90 1 55 17 FEV1 PEF 7 22 6 64 116 10 93 34 y epow 4 Sibelmed DATOSPIR MICRO User s Manual 66 2 8 CALIBRATION PROCEDURE GENERAL OBSERVATIONS The Normative in force regarding spirometry recommends that all spirometers be perfectly calibrated This is due to the alterations that may modify the characteristics of the electronic circuits and mechanical aprts over time and cause a change in the spirometer calibration factors Hence a calibation system has been incorporated based on a volume signal of reference e g a syringe Furthermore this calibration factor must take the changes in volume associated to atmospheric conditions into account The most influential factor is temperature The DATOSPIR MICRO includes a Calibratio
62. PIR spirometer is very useful for monitoring and controlling asthmatic patients or others to suit the specialist s criteria whether they are at home or in hospital With this option the spirometer is extremely user friendly equipment as the sequence of instructions on screen will guide patients during spirometric manoeuvres At the same time it automatically saves the best manoeuvres made in the different tests in the memory This enables the specialist to subsequently analyse them and make the corresponding diagnosis It is also possible to transfer them from the equipment Database to the PC Database using W20 Spirometry Software Three stages can be described for a better understanding of this operating mode 1 Spirometer configuration 2 Acquisition of spirometric tests 3 Displaying of the information saved CONFI GURATI ON The specialist must configure the spirometer in HOME mode and provide the patient with the necessary instructions The process to follow is as described below From the main screen press and then press Sibelmed DATOSPIR MICRO User s Manual 173 Home mode customisation includes the customisation of the patient s details and the test data Press enter the patient s details sC d Between 0 and 9999999999 6 Sex Between male and female C d xxx Between 0 and 100 cigarettes day Age Between 4 and 100 Cm xx
63. PRE and POST mode and the method of comparison between them depending on the option selected in customisation See section 3 2 EQUIPMENT PROTECTION Weighted between PRE and POST between REF and POST between PRE and POST Difference between PRE and POST The most common method of comparison is the Weighted which corresponds to WEIGHT 100x2 POST PRE POST PRE See J E Cotes Lung Function Assessment and Aplication in Medicine Blackwell Sci 4th Edition 1979 p52 53 The registering of parameters and graphs is as shown below 5 DATOSPIR MICRO ROSSELLO 500 PULMONARY FUNCTION TEST Code Name Sex Temp References Reason Origin Technician Bios Ver FVC REPORT FVC ET FEV1 FVC PEF ong 0000000001 Male age 26 Pres mmHg 760 SEPAR 5115AB 1 00 MANOEUVRE No et Ke BU MOouO o N SIBEL S A 08026 BARCELONA Ro AR AUCOBU BUI IRN NW B BUIONE UI DATOSPIR MICRO User s Manual DATOSPTIR MICRO Date 04 06 2006 Time 174 Wt 7 Height cm Humidity Ethnic Prog Ver 8 m n CRWWOAR BOD BU ero PM NOU Sibelmed 5115AF 1 00 pue SJapowW 4e3deu QUINOO 040 Chapter 3 Models Operation 5 DATOSPIR MICRO User
64. R MICRO User s Manual 176 Home mode is now configured so that you simply have to press on the main screen to enable it and to switch off the equipment ACQUISITION OF SPIROMETRIC TESTS Once the equipment has been configured by the specialist the test acquisition process can begin The storage capacity is 150 or 1000 tests depending on the database or H The specialist will explain the test to the patient particularly the forced expiration manoeuvre process the equipment operating sequence and when the tests should be taken The operating sequence is as follows If start up is manual the patient starts the equipment l The start screen will appear along with the model the programme version and the bios version the date and the time If start up is automatic because it is the time programmed in Alarms l The equipment will start up and the start screen will appear along with the model the programme version and the bios version the date and the time The following screen will then appear E7277 22 219 MB DATOSPIR MICRO User s Manual 177 55 gt TO START TEST and the equipment will issue a beeping sound every 10 seconds If for 2 minutes the equipment is not pressed it will switch off Press the key 2 The following screen will appear The patient can start the manoeuvre after the arrow has appeared they have 30 seconds 5 pue sja
65. Where this is not the case point 4 is repeated DATOSPIR MICRO User s Manual EXP Fas INSP F 85 11 CALIBRATED 3 08 1 24 nm m 6 Once calibrated exit the Calibration Programme and access the Spirometry programme to begin the tests Note If upon entering the calibration parameters in point 2 Calibration Volume 1 0 is allocated the system takes the calibration factors EXP F and INS F 1 00 corresponding to original factory calibration This calibration should only be used as a guideline and in the event of no syringe being available CALIBRATION REGISTERING The spirometer has a register containing the expiratory and inspiratory factors of the last ten calibrations performed This is extremely useful for centres requiring a quality control of the processes they use To do so press on the first calibration process screen Chapter 3 Models Operation FS SI DATOSPIR MICRO User s Manual The following screen will appear REGISTER NUMBER 03 265 18 87 3 00 1 82 1 87 O3 B6 06 18 87 3 80 1 81 1 05 Deletes a register 5 Prints existing registers 4 and hd Moves around the different calibrations The information shown is Number of registers available Date of calibration Time of calibration Volume of calibration Expiratory factor Inspiratory factor
66. YY 1 yy X XX Observed Value of the parameter in this case FVC YY between the Observed value and the value of Reference Observed Value of the parameter in this case FEV1 yy between the Observed value and the value of Reference ATTENTION Check in the Customisation Programme that the REFERENCES and the ETHNIC FACTOR are suitably selected The ethnic factor modifies the value of the References according to the percentage selected 100 is equivalent to the unmodified standard value of the References Using the selection keys v it is possible to view the observed value and the percentage in relation to the value of reference for each customised parameter If a parameter does not have a Value of Reference the corresponding percentage will not appear 6 Press the gt key again and complete new manoeuvre As many manoeuvres as required can be completed The DATOSPIR MICRO will always save the five best for FVC and VC and the three best for MVV according to ATS ERS criteria No more than eight manoeuvres should be made so as not to tire the patient DATOSPIR MICRO User s Manual If three or more manoeuvres have been completed and the FVC and or FEV1 parameters are flashing this indicates that the repeatability criterion for one or both parameters has been met This criterion indicates that the best two observed values of FVC and the bes
67. ain Menu screen press 85 01 86 MAIMTEMAMCE 99 CAL ouch zr Enables the calibration and or maintenance warnings E Adjusts the screen contrast CAL TouchPannel calibration Auto checks the equipment Checks with pre saved standard curves Equipment configuration WARNINGS Select the option The following screen will appear with the information on the Sibelmed DATOSPIR MICRO User s Manual latest maintenance work the tests performed and the tests performed since the last maintenance work WARNING SELECTION Last Maintenance 5 06 2086 Total Tests Tests Since Last Maintenance Press WARMING SELECTION Calibration Period Maintenance Period This screen defines the periods in days between calibrations or between preventative maintenance work on the equipment If the days specified without calibration or maintenance are exceeded the equipment warns of such by displaying a sign every time it is started If 0 days is entered a warning is never given LCD CONTRAST FS SI DATOSPIR MICRO User s Manual Select the option to configure the screen contrast LED CONTRAST Go back to the previous screen m Black background white content m White background black content rS Validate choice 2 and gt Increase decrease contrast EQUI PMENT CHECK Select the option to check differ
68. al provided by the syringe must be produced with different pulses to check whether the flow reading remains steady as the appliance must always integrate the signal in the same volume that provided by the syringe signal whatever the suddenness of the injection manoeuvre with the upper limit of the flow range precisely measured close to the real value by the instrument in question not being exceeded Calibration with a dynamic signal produced by the explosive decompressor or the measuring of spirometry on control individuals as mentioned above may be performed relatively less often It is wise to perform calibration using the decompressor every fortnight in the case of pneumotachometers Given that spirometry with control individuals DATOSPIR MICRO User s Manual 211 is more complicated and less accessible this procedure cannot be performed more often than every month or whenever the appliance is thought to be malfunctioning Table I Variability of spirometry in healthy patients Variation coefficient Variables Age 6 20 20 70 FVC 1 9 2 2 FEV1 2 2 2 2 25 75 6 5 4 8 FEF50 FVC 5 3 4 7 Values corresponding to 33 healthy volunteers Values from 20 healthy adults According to ATS ERS standardisation parameters MEF50 is replaced by 50 7 3 VALUES OF REFERENCE FOR FORCED SPIROMETRY SEPAR The DATOSPIR MICRO spirometer includes different tables of reference t
69. ameters are calculated upon accessing this screen This option may take a few seconds depending on the length of the study Press the key to access the parameters screen nup 3 pue PARAMETERS 4 3 8 3 43 3 43 ESC Exits this screen and goes back to the previous one j Prints the study report Saves Parameters the Database 4 and Moves around the different parameters Once a test has been saved on the Database it can be retrieved in the same manner as any spirometric test The parameters calculated to display print or save on the Database are as follows CT90 CT80 CT70 IDH 4 IDH 3 IDH 2 Maximum S of time in which SpO is below 90 of time in which SpO is below 80 of time in which SpO is below 70 Desaturation index gt 4 per hour Desaturation index gt 3 per hour Desaturation index gt 2 per hour pO Maximum Saturation value e Average SpO Average Saturation value 2 Minimum SpO Minimum Saturation value Std SpO Standard Saturation value Maximum PR Maximum pulse rate value Average PR Average pulse rate value Minimum PR Minimum pulse rate value Std PR Standard pulse rate deviation Test Time Useful test time when the finger clip is disconnected is not considered NOTE Any time during which the finger clip is disconnected is not taken into account when calcula
70. anoeuvre 1 ir M RAN _ RAMIN ja lemini 61 inge 181 60 141 3s U IREF 481 60 167 78 44 42 157 78 44 12 0 aes 2 The axes are displayed in VOLUME TIME mode 3 Instruct the patient as to how to the test is being carried out as his cooperation is vital for it to be completed correctly 4 The maximum time allowed for the manoeuvre is 15 seconds The equipment saves a maximum of three manoeuvres ordered according to the MVV value where M1 is the best MVV and M3 the worst 5 The registering of parameters and graphs is as shown below SSN S Ge med DATOSPIR MICRO User s Manual Sibelmed DATOSPIR MICRO SIBEL S A ROSSELLO 500 08026 BARCELONA PULMONARY FUNCTION TEST DATOSPIR MICRO Code 0000000001 Date 03 22 2006 Time 17 52 Name 1 Age y 26 Height cm 174 Wt Kg 68 Temp 26 Pres mmHg 760 Humidity 60 Smok I 0 References SEPAR Ethnic 100 Origin Technician Bios Ver 5115AB 1 00 Prog Ver 5115AF 1 00 MVV REPORT MANOEUVRE No 1 1 PARAMETER OBS REF MVV 1 min 150 82 179 00 84 Br min 44 12 193deu5 5 S be med DATOSPIR MICRO User s Manual 134 3 7 POST BRONCHIAL DILATOR SPI ROMETRY PROCEDURE The DATOSPI R MICRO spirometer allows for Post bronchial dilation tests to be carried
71. any problem that the user cannot solve contact the SIBEL S A After Sales Service or your distributor to review or repair it 3 The user can access the Maintenance Programme to adjust and or check any parts of the equipment as indicated in detail in the corresponding section 4 A fourth type consists of a general technical check of the safety systems adjustments and functions etc forming the equipment THIS TECHNICAL CHECK WI LL BE PERFORMED EVERY YEAR and in line with the DATOSPI R MI CRO Verification and Adjustment Procedure available from the manufacturer This type of operation must be carried out by skilled technical staff from the hospital s maintenance department or from the distributor s or manufacturer s technical service helmed DATOSPIR MICRO User s Manual On all accounts SI BEL S A as the manufacturer must provide written authorisation for at least the guarantee period for the corresponding technical personnel to carry out said maintenance and will not be held liable under any circumstances for any damage malfunction etc that may arise as a result of defective maintenance by people not belonging to SI BEL S A 8 3 CORRECTI VE MAI NTENANCE Corrective maintenance consists of leaving equipment that has stopped working and must be repaired due to malfunctioning or misuse in a good state of repair Where a fault is detected in the equipment which prevents it from being used normally contac
72. ator Parameter selection and FEV1 the two with the highest value of the tests saved Remaining parameters of the selected test with the highest sum being recommended Keypad All instructions data etc transmitted by the operator to the microprocessor involve a keypad with silicon keys Model A or a touch screen Models B and C Comunicaci ns channel RS232C USB 2 0 Bluetooth 2 0 Chapter 5 Technical Specifications S be med DATOSPIR MICRO User s Manual 198 Compatible with HP PCL black and white color printers 5 4 PRESENTATION OF DATA LCD Liquid Crystal Display of 2x16 Model A or high resolution touch screen LCD Liquid Crystal Display with array of 240 x 160 points Models B and C By external printer By PC with the corresponding software 5 5 TEMPERATURE SENSOR Internal temperature sensor from 0 to 50 2 5 6 GENERAL DATA Relative humidity e Less than 75 without condensation Barometric pressure Between 430 and 800 mmHg approx 4500 to 400 metres altitude Temperature 6 DATOSPIR MICRO User s Manual 199 Storage between and 60 C Working between 10 and 40 C Applicable standards Spirometry ATS ERS SEPAR Safety EN 60601 1 EN 60601 1 1 Electro magnetic Compatibility EN 60601 1 2 See Appendix 1 Quality EN 13485 ISO 9001 2000 Spirometers for peak espiratory flow
73. best manoeuvre to memory according to the following criteria The one with the best sum of FVC FEV1 is considered the best The one with the best FVC is considered the best The one with the best FEV1 is considered the best The curves with warnings ET EX are considered the worst 5 As a guideline for subsequent control and diagnosis patients can note down where applicable one or several of the different symptoms during the test COUGH PANTING BREATHING DIFFICULTIES or MUCOSITY The severity can be chosen for each symptom from among the following values NONE No symptom LOW MEDIUM HIGH IMPORTANT NOTE Proceed as follows to go from HOME MODE to HOSPITAL MODE For equipment with the key Keep the keys v and gt pressed down at the same time and restart by pressing Srbelmed DATOSPIR MICRO User s Manual 95 The following warning will appear on screen after a few seconds RELEASE THE KEYS You should then release keys v and gt The spirometer is now HOSPI TAL mode DISPLAYING SAVED INFORMATION The information saved can be displayed on the DATOSPI RMI CRO spirometer or on the PC using the W20 Spirometry Software In both cases the aforementioned options can be chosen consulting parameter printing a report etc jepoyw Chapter 2 Model A Operating DATOSPIR MICRO User s Manual 96
74. ccording to one of the following ATS ERS criteria ET Indicates that spiration has not completed satisfactorily as the variation on volume in the last second of the manoeuvre was above 25 ml or the manoeuvre has lasted less than 6 seconds in patients aged over 10 and more or less than 3 seconds in patients aged 10 or less EX Indicates that the start of expiration was not satisfactory as the extrapolated volume is above 5 of the FVC or 0 15 litres The ATS ERS recommends it be less than 59o of the FVC or 0 15 litres whichever is highest The technician performing the spirometry may where considered appropriate disable these warnings in the Customisation Programme n this case they will also be removed from the printed report This disabling is only at display level The warnings are still taken into account when ordering the manoeuvres ATTENTI ON Check in the Customisation Programme that the REFERENCES and the ETHNI C FACTOR are suitably selected The ethnic factor modifies the value of the References according to the percentage selected 100 is equivalent to the unmodified standard value of the References 5 Perform new spirometric manoeuvres 57 helmed DATOSPIR MICRO User s Manual 119 The new graph is superimposed to compare it with the best 1 dotted line of those saved e 5 many manoeuvres as required can be carried out The DATOSPIR MICRO will always save the five best for and VC and t
75. e the equipment to the factory and without having to open it WARNING Both updates are completed through the series port RS232 BIOS UPDATE The updating process for the BIOS programme is as follows l Run the W 20 Spirometry Software and access the Configuration Hardware Test option Run a communications test to check that the connections are correct 2 Switch the equipment off 3 With the DATOSPIR MICRO switched off remove the rear cover disconnect the bluetooth where applicable and turn both switches ON DATOSPIR MICRO User s Manual 85 WARNING This option should be carried out by an expert or specialist 4 Turn the equipment and support it on the table with the screen visible 5 Press the key for 1 second and release Nothing will appear on the screen 6 Copy the Bios file DMBios tsk into the FIRMWARE directory of the application W20 7 Run the W 20 Spirometry Software access the Configuration Links option and check that the DATOSPIR MICRO is selected 8 Access the Configuration Utilities Update Bios option 9 Follow the instructions on screen and wait for the process to end 10 Once completed turn both updating switches OFF again replace the Bluetooth where applicable and close the cover FLASH UPDATE Flash can be updated for a new version of the programme in which improvements have been included or to add another option to the equipment dilation optio
76. ear MAIN MENU 1 Spirometry VEN DATOSPIR MICRO User s Manual 89 Using the or keys select the option MAIN MENU 4 Customise and then CUSTOMISATION 2 Home Mode JePOW Home mode customisation includes the customisation of the patient s details and the test data Select HOME MODE 1 Patient Details and enter the data requested on the successive screens PATIENT DETAILS Code Between 0 and 9999999999 PATIENT DETAILS Age years xx Between 4 and 100 PATIENT DETAILS Height cm xx Between 50 and 230 cm PATIENT DETAILS Weight Kg xx Between 15 and 200 Kg S be med DATOSPIR MICRO User s Manual PATIENT DETAILS Sex Female Between male and female PATIENT DETAILS Cig day xx Between 0 and 20 cigarettes Select HOME MODE 2 Test data to configure the semaphore and the alarms The following screen will appear SEL SEMAPHORE FVC FEV1 PEF Select the parameter of reference for the manoeuvres The value of REFERENCE will then appear depending on the age weight etc of the patient and the tables enabled in the Customisation programme This value can be changed by the specialist for patients who under controlled conditions of asthma have a significant deviation regarding the standard of the reference The value programmed will be equivalent to 100 in the subsequent control REFERENCE VALUE
77. ed out by skilled staff Review Chapter 7 SPIROMETRY TECHNIQUE or ask for a spirometry course from SIBEL S A Patients can carry out the spirometry manoeuvres in two different ways The first consists of starting to move the turbine with FORCED EXPIRATION followed by FORCED INSPIRATION if required The second consists of the patient breathing normally through the turbine and when indicated by the technician fill his lungs full of air and then start FORCED EXPIRATION followed by FORCED INSPIRATION if required 3 Inform the patient of the way of holding the equipment when using the spirometer taking care not to press any key and fitting the nose clip as shown in the following figure Chapter 2 Model A Operating FS SS DATOSPIR MICRO User s Manual 44 FVC TEST 4 Select the screen 1 Start Manoeuv and press the gt key The following screen will appear MEASURING The equipment is held so that the doctor can see the screen while the patient is carrying out the tests On the left hand side is a rectangle indicating that the equipmen is ready for the test to be started The patient has 30 seconds to begin After this time if he has not started the equipment will switch to standby and must be pressed again After the expiratory manoeuvre the second line of the screen will show a bar movement of which is proportional to the volumen of the expiratory manoeuvre The maximum value of the bar
78. een PRE and POST between REF and POST between PRE and POST Difference between PRE and POST Printout of warnings of Non Compliant manoeuvres with ATS ERS criteria e SpO Pulse oximetry customisation NE 5 DATOSPIR MICRO User s Manual Equipment protection customisation Modifying the pin MAI NTENANCE Warning selection Period between calibrations Period between maintenance work Adjusting the LCD contrast TouchPannel calibration Checking hardware Checking with standard curves FVC VC MVV Others Notifies Programme Update key and allows System initialisation OPERATI NG MODE Home Hospital PULSE OXI METRY Test data Patient Code Full name Age height weight and sex Configuration Average in the SpO Saving Trends Displaying Trends Configuration Signal forwards and backwards Test Parameters Parameter printout Saving parameters on the database Chapter 3 Models Operation S be med DATOSPIR MICRO User s Manual 102 DILATI ON Carrying out Post bronchial dilation test REPORT Printing a report BLUETOOTH Enabling or disabling Bluetooth Sibelmed DATOSPIR MICRO User s Manual 3 2 EQUIPMENT CUSTOMISATION Every user should customise the DATOSPI spirometer according to their requirements due to the variety of options included The different options included in the Customisation menu are explained in detail in the previ
79. ent parts of the equipment 93 95 96 EQUIPMENT 18 45 mur ESC Srbelmed DATOSPIR MICRO User s Manual 165 e E o Go back to the previous screen Distributor details Pulse oximetry module Check the external printer selected The SIBELMED logo the heading lines and 10 lines of characters will be printed Check that the automatic on and off work properly Upon selecting this option the equipment switches off and on automatically after 5 seconds Display the values of different variables No pulses Turbine Fct Alk B Li B etc This indicates whether the read value is correct Dewi of Pulses Turbine Factor Vari ables 4 V WOE Alkaline Bat Vs Lithium Bat Wis EM Temrerature I CPU check This calculates the Flash programme checksum and the Bios programme checksum It also indicates whether there are errors in the RAM memory of the CPU and in the external RAM Chapter 3 Models Operation FS SI DATOSPIR MICRO User s Manual CHECEING Qx67 FRR Flash Checksum Bios Checksum x4850 CFU Ram External Ram LCD Performs a test on the LCD Follow the instructions given on the screen Touch Screen STANDARD CURVES Select the option to check the working order of the equipment through certain pre saved curves 93 95 96 STAND CURVES 19 54 MV
80. equipment 57 DATOSPIR MICRO User s Manual In models B and C in order to save power Lcd backlight will be switched off if the equipment is not used in 20 seconds WARNI NG When inserting the batteries for the first time or when changing them the equipment may switch on automatically This is normal and does not indicate any type of malfunctioning Atmospheric conditions The atmospheric working conditions are Atmospheric temperature between 10 and 40 9C The American Thoracic Society recommends 17 to 40 9C Relative humidity below 75 without condensation e Atmospheric pressure from 430 to 800 mmHg from approx 4500 to 400 metres Location Take care not to place the equipment where it could be splashed by water or other liquids or cover it with objects that prevent air from circulating around it while it is running Once the batteries have been inserted and the equipment is in a suitable place it is ready to begin operating USB MODULE INSTALLATI ON The equipment includes a Microcontroller exclusively for USB control which is ready for use For use with a PC simply install the USB driver and the W20 Spirometry Software in the PC For both installations consult the W20 Spirometry Software User Manual 5 DATOSPIR MICRO User s Manual 24 BLUETOOTH MODULE INSTALLATI ON This case is similar to the above By inserting the optional Bluetooth module the equipment
81. equipment off 3 With the DATOSPIR MICRO switched off remove the rear cover disconnect the Bluetooth where applicable and turn both switches ON NE 5 DATOSPIR MICRO User s Manual WARNI NG This option should be carried out by an expert or specialist 4 Turn the equipment and support it on the table with the screen visible 5 Press the On Off key for 1 second and release it Nothing will appear on the screen 6 Copy the Bios file DMBios tsk into the FIRMWARE directory of the application W20 7 Run the W 20 Spirometry Software access the Configuration Links option and check that the DATOSPIR MICRO is selected 8 Access the Configuration Utilities Update Bios option 9 Follow the instructions on screen and wait for the process to end 10 Once completed turn both updating switches OFF again replace the Bluetooth where applicable and close the cover FLASH UPDATE Flash can be updated for a new version of the programme in which improvements have been included or to add another option to the equipment dilation option Bluetooth etc 5 DATOSPIR MICRO User s Manual In the case of the latter SIBEL S A will provide a new update key In the case of the former consult the key in the equipment before starting the update process Switch the DATOSPIR MICRO on and from the main menu select Select and consult the update key that appears on the screen
82. er s Manual 25 For information on the Data Protection Act LOPD consult APPENDIX 2 START UP To start the MICRO spirometer press the key The equipment will then make a beeping sound and will check itself The 51 1 logo the name of the equipment the programme version and the address of SIBEL S A will appear on screen for two seconds If equipment protection is enabled the PIN entry screen will appear If equipment protection is not enabled or if the correct PIN has been entered the MAIN MENU will then be displayed which varies according to the model Model A MAIN MENU uonejjeasu pue esf 104 suononagsu T 493deu 93 96 96 DATOSPIA MICRO 16 02 mmm BLUE SW TOOTH m The first time the equipment is started the protection is disabled and the PIN is set to 0000 See Section 2 2 3 2 EQUIPMENT CUSTOMISATION to enable it and configure the PIN HANDLING THE EQUIPMENT The spirometer has been developed to make it user friendly so that it is easy and simple to use The equipment may seem difficult to handle given its multiple functions although its design and use will quickly show you that it is truly easy and intuitive for any medical staff All functions are accessible from the 4 silicon keys located underneath the screen Model A or using the icons on the screen that can be selected using a pointer Models B and C All models can be connected as
83. erent test modalities FVC VC MVV or Dilation despite them not being selected in the Customisation programme Different functions are possible from the spirometer l Search the database 2 Search for a patient Chapter 2 Model Operating FS SI DATOSPIR MICRO User s Manual 74 3 Search for a register 4 Print a summarised report 5 Delete the database To do so start the DATOSPIR MICRO using the key and wait for the following screen to appear MAIN MENU 1 Spirometry Using the or v keys select the option MAIN MENU 3 Database Press the key gt and with or v select the required function DATABASE SEARCH The DATOSPIR MICRO displays the parameters saved in the database for each test If this is to be carried out on a regular basis use the W20 Spirometry Software to conveniently view all the saved parameters SST DATOSPIR MICRO User s Manual 75 Select the option DATABASE 1 Search DB to display the results of the tests saved in the database consult the diagnosis of each one if the option is enabled print a report or delete a test from the database Press the key gt and with a or select the option required Pat Code Test 1 Results Pat Code Test 2 Diagnosis Pat Code Test 3 Report Pat Code Test 4 Delete test PATIENT SEARCH Select the option DATABASE 2 Search Pat jepoyw
84. f the last ten calibrations performed This is extremely useful for centres requiring a quality control of the processes they use To access this register select the option CALIBRATION 2 Calibration DB Press gt and using keys and v access the option required CALIBRATION DB 1 Reg Data Displays the data on the last ten calibrations JePOW Chapter 2 Model Operating S be nmed DATOSPIR MICRO User s Manual CALIBRATION DB 2 Delete Reg Deletes the data on the calibrations saved CALIBRATION DB 3 Report Prints the register with the calibrations 72 DATOSPIR MICRO User s Manual 73 2 9 INTERNAL DATABASE The DATOSPIR MICRO has an Internal Database as standard that saves the different tests made using the equipment and subsequently displays them prints them and or transfers them to a PC or other computerised system for storage or management The base information remains even when the equipment is turned off or the batteries are removed There are two bases with the same functions but different capacities Database L Database H The tests that can be saved using six second as reference are Database L 150 Database H 21000 The saving of the tests has already been described in the sections corresponding to each test The database always saves all the spirometric parameters of each of the diff
85. f the patient exists the database search screen will appear Where this is not the case the following warning message will appear PATIENT CODE NOT FOUND STER SEARCH Select the option Al to search for a register in the database S be med DATOSPIR MICRO User s Manual The following screen will appear REGISTER SEARCH REGISTER aj 2 3 4 Enter the register number and press If the register exists the database search screen will appear Where this is not the case the following warning message will appear REGISTER ID NOT FOUND SUMMARI SED REPORT Select the option to print a report with the list of tests saved on the database The following screen will appear to indicate the printing process PRINTED REPORT 7 SSI S be med DATOSPIR MICRO User s Manual 161 DELETE DATABASE Select the option to delete the database The following message will appear THE DATABASE WILL BE DELETED YOU SUR ESC ESC Press to accept and delete the database or press to go back to the previous screen without deleting it pue cn Uf Models B and 3 Chapter 5 DATOSPIR MICRO User s Manual 3 11 MAINTENANCE PROGRAMME The equipment has a maintenance programme to adjust and or check the working order of certain options From the M
86. gh the immediately inferior values are not rejected Retrograde extrapolation The start of the FVC manoeuvre is established through retrograde extrapolation according to A T S criteria Identification of the end of inspiration The end of the FVC manoeuvre is established according to A T S criteria i e when the volume accumulated in the last second is below 30ml Calibration programme DATOSPIR MICRO User s Manual Turbine Any ageing of or accumulated dirt in the turbine transducer may lead to imprecise measurements To ensure the turbine measures correctly the system includes a simple checking procedure based on measuring the known volume of a calibration syringe 6 4 PULSE OXI METER The DATOSPIR MICRO includes an electronic module exclusively for taking Oxygen Saturation and Pulse Rate samples This module is powered by the motherboard and communicates with it through a specific series port The pulse oximetry measurement principle is based on the different absorption of certain wave lengths red and infrared through the arteries depending on the amount of Haemoglobin transported by the red cells The wave lengths used are 660 nm for red and 910 nm for infrared 9 9 Chapter 6 Operating Principles Sibe med DATOSPIR MICRO User s Manual 206 27027 EMEN 7 SPIROMETRY TECHNIQUE nb uyp L 5 19
87. hat may be selected using the Customisation programme Below are the equations corresponding to the SEPAR and ECCS 93 references Should you require any other table please consult SIBEL S A Jo3deu L L enbiuuy 5 DATOSPIR MICRO User s Manual 212 Multi centre study in Barcelona Variable Sex FVC M F 1 FEV1 FVC M FEF 25 75 F PEF M F FEF 50 FVC M F FEF 75 FVC M F Variable FVC FEV1 FEV1 FVC FEF 25 75 PEF FEF 50 FVC FEF 2596FVC FEV1 PEF FEV1 FEVO 5 FEF50 FIF50 PEF PIF FEV1 FIV1 TENaETNENENEMNEMNENEMNEMNENENE Equation Age 6 20 R 0 02800T 0 03451P 0 05728E 3 21 0 947 0 03049T 0 02220P 0 03550E 3 04 0 935 0 02483T 0 02266P 0 07148E 2 91 0 945 0 02866T 0 01713P 0 02955E 2 87 0 940 0 593E 0 113P 81 60 0 026T 0 038T 0 046T 0 075T 0 073T 0 017T 0 046T 0 024T 0 027T Equation Age 20 70 R 82 60 0 140E 0 051E 0 275E 0 134E 0 157E 0 067E 0 066E 0 032E 0 029P 2 17 4 33 4 30 9 08 7 57 4 17 2 61 2 68 0 0678T 0 0147E 0 0454T 0 0211E 0 0499T 0 0211E 0 0317T 0 0250E 0 1902E 85 58 0 224E 0 1126P 94 88 0 0392T 0 0430E 1 16 0 0230T 0 0456E 1 11 0 0945T 0 0209E 5 77 0 0448T 0 0304E 0 35 0 0517T 0 0397E 2 40 0 0242T 0 0418E 1 62 0 0190T 0 0356E 0 14 0 02T 0 031E
88. he three best for MVV according to ATS ERS criteria The different regulations recommend at least three satisfactory manoeuvres in which the repeatability criterion is complied with but no more than eight as this would tire the patient The last manoeuvre entered remains flashing and corresponds to the continual line graph Where more than five manoeuvres have been entered and none are flashing this indicates that the last entered is worse than the five saved and will be deleted If three or more manoeuvres have been completed and the FVC and or FEV1 signs are flashing this indicates that the repeatability criterion for one or both parameters has been met according to the ATS ERS This criterion indicates that the best two observed values of FVC and the best two of FEV 1 differ in no more than 150 ml if the FVC is greater than 1 litre or in no more than 100 ml if the FVC is below or equal to one litre 5C NOTE Remember that by using the back key it is possible to go backwards in the menu without losing the information available to date unless you change patient by entering a new code or on another occasion although this is previously indicated on screen ATS ERS criteria The manoeuvre with least warnings is considered the best ET EX With the same number of warnings the manoeuvre with the highest value sum of FVC FEV1 is considered the best 5 DATOSPIR MICRO User s Manual DISPL
89. here M1 is the best VC and M3 the worst 4 To measure the ERV and TV parameters correctly each manoeuvre must have at least four respiratory cycles 5 The register of parameters and graphics is as shown below ing Model A Operati Chapter 2 FSS 7 DATOSPIR MICRO User s Manual Sibelmed DATOSPIR MICRO SIBEL S A ROSSELLO 500 08026 BARCELONA PULMONARY FUNCTION TEST DATOSPIR MICRO Code 0000000001 Date 03 22 2006 Time 17 52 Sex Male Age y 26 Height cm 174 Wt Kg 68 Temp C 26 Pres mmHg 760 Humidity 60 Smok I 0 References SEPAR Ethnic 100 Reason Origin Technician Bios Ver 5115AB 1 00 Prog Ver 5115AF 1 00 VC REPORT MANOEUVRE No 1 1 PARAMETER OBS REF 5 vc 1 236 TV L TIL ERV 1 0 72 lt 5 7 DATOSPIR MICRO User s Manual 61 2 6 MAXIMUM VOLUNTARY VENTILATION MVV TEST PROCEDURE The procedure to carry out the Maximum Voluntary Ventilation MVV test is similar to that described in Section 2 4 FORCED VITAL CAPACITY PROCEDURE with the following variations 1 If the test is carried out on the same patient as described in the OTHER TESTS ON THE SAME PATIENT section go back using the key to the Test Selection window and select using keys or v the MVV test SPIROMETRY 3 MVV If the patient is new begin as described in the ENTERI NG PATI ENT PARAMETERS section 2 Instruct
90. ings Printout of warnings of Non Compliant manoeuvres with ATS ERS criteria Date of latest calibration CUSTOMI SATION OF THE HOME MODE In this option it is possible to configure the DATOSPI R MI CRO for use in home mode See section 3 13 HOME MODE OPERATION STANDARD CONFI GURATI ON This option memorises a user defined customisation programme status to retrieve it at any time globally and automatically This option restores the original customisation if it has been modified either voluntarily or inadvertently In general this configuration will correspond to that most often used CONFIG STANDARD 16 07 mm S be med DATOSPIR MICRO User s Manual Restores the standard configuration Saves the standard configuration Follow the instructions below to save the Standard configuration 1 Customise each of the following options Home mode customisation Database customisation Common customisation Spirometry customisation Pulse oximetry customisation Protection customisation as described in this section 2 Go back to the Standard Configuration option and press the key 3 Your Standard Configuration has now been memorised Should you need to modify a customisation option during a test it can be accessed manually and modified The Standard Configuration can be restored at any time To do so press the key el DATOSPIR MICRO User s Manual COMMON CUSTOMISATION This option cu
91. ion Programme Press the gt key to go to the TEST screen Use the or v keys to select one of the following options FVC TEST 1 Start Manoeuvre Allows for spirometric manoeuvres to be acquired FVC TEST 2 Results Displays the results of the best three manoeuvres FVC TEST 3 Diagnosis Displays the diagnosis according to the results obtained FVC TEST 4 Save DB Saves the selected manoeuvre to the Database Chapter 2 Model Operating FS SI S be rmed DATOSPIR MICRO User s Manual FVC TEST 5 Save PRE Saves in the Database as PRE FVC TEST 6 Report Prints the report on any completed manoeuvre FVC TEST 7 Delete Deletes any manoeuvre FVC TEST 8 New Patient Option to change patient or to change some datails of an existing patient 42 ENTERING FORCED VITAL CAPACITY FVC TESTS The technician to carry out the forced spirometry tests must know the normal procedures required so that the patient can be coached Where this is not the case certain documentation on the matter must be reviewed DATOSPIR MICRO User s Manual 43 When undertaking spirometry take the following steps into account 1 Check that the turbine is correctly inserted with the mouthpiece as in the figure INSERT FIRMLY 2 Instruct the patient as to how to carry out the test as his cooperation is vital for it to be completed correctly WARNING The test must be carri
92. is ready to transmit data via Bluetooth For use with a PC simply install the Bluetooth module and the W20 Spirometry Software in the PC The PC is then ready to receive the data transmitted by the equipment For both installations consult the W20 Spirometry Software User Manual Once the Bluetooth module has been configured in the PC a connection will be established every time the equipment and the PC are started Although the DATOSPIR MI CRO internal Bluetooth module uses batteries particularly during data transmission it is wise to disable the module if no connection with the PC is required This will extend the working life of the batteries The Bluetooth is enabled and disabled by accessing the Bluetooth option on the main screen EQUI PMENT PROTECTI ON In compliance with the Data Protection Act LOPD the DATOSPI R MICRO has an equipment protection option accessed by PIN accessed by a pin of 4 digits This option can be customised enabled or disabled as required Where enabled a screen will appear requesting the PIN user configured when the equipment is started If an erroneous PIN is entered three times the equipment will lock and will switch off On restarting it a screen will appear requesting the unlock code or PUK supplied to the purchaser of the equipment This prevents access to the equipment and more specifically to the private data it contains by unauthorised people 6 6 DATOSPIR MICRO Us
93. ition taken by the last manoeuvre entered The flasing text indicates the manoeuvre selected the best M1 is selected by default Select the manoeuvre to be saved using the keys and v appearing between brackets and press gt The following screen will appear for few seconds MANOEUVRE N X SAVED If you have made a mistake or wish to modify the manoeuvre repeat the process 5 DATOSPIR MICRO User s Manual ATS ERS criteria The manoeuvre with least warnings is considered the best ET EX With the same number of warnings the manoeuvre with the highest value sum of FVC FEV1 is considered the best Memorising a test to compare it in POST bronchial dilation mode This options allows for a test to be saved in PRE bronchial dilation mode to then compare it with POST bronchial dilation mode The process is similar to that described above but previously selecting the option FVC TEST 5 Save PRE Press the gt key similar screen to the following will appear depending on the number of manoeuvres made SAVE PRE M1 M2 M3 4 M5 Select the manoeuvre to be saved using the keys and v appearing between brackets and press gt DATOSPIR MICRO User s Manual 53 The following screen will appear for a few seconds MANOEUVRE PRE N X SAVED If you have made a mistake or wish to modify the manoeuvre repeat the process PRINTING T
94. memory The average of both values will be displayed on completion of the manoeuvre The Pulse Oximetry menu must be accessed to retrieve all the measured values from the memory This will be dealt with like a Pulse Oximetry test saved in the memory Sibel med DATOSPIR MICRO User s Manual 149 3 9 CALIBRATION PROCEDURE GENERAL OBSERVATIONS The standards in force regarding spirometry recommend that all spirometers be periodically calibrated This is due to alterations which may modify the characteristics of the electronic circuits and mechanical elements over time and cause a change in the spirometer calibration factors Hence a calibration system has been incorporated based on a reference volume signal e g a syringe Furthermore this calibration factor must take the changes in volume associated to atmospheric conditions temperature relative humidity and barometric pressure into account The most influential factor is temperature followed by the humidity level DATOSPIR MICRO includes a Calibration Programme for fast less than one minute and easy checking and auto correcting of deviations in the measurements taken based on a standard or reference volume for the quality control of the different spirometric tests The regularity of calibration depends on the user although the standards recommend it be done on a daily or weekly basis CALIBRATION PROCESS The calibration process is as follows 1 Install the s
95. ment compliant with the electrical safety standards in force may be connected to this device To connect Datospir Micro to a non medical equipment with earth conductor it must be installed an aditional earth protective conductor to the non medical equipment The equipment must be stored and used within the temperature pressure and humidity margins specified Srbelmed DATOSPIR MICRO User s Manual RISKS OF EXPLOSION Do NOT use the equipment in the presence of anesthetics or inflammable gases THIS MAY CAUSE AN EXPLOSION RISKS OF CONTAMINATION Turbine transducer To avoid the risk of contamination or cross infection the turbine must be disinfected as indicated in this manual Mouthpieces Reusable mouthpieces must also be disinfected Disposable mouthpieces must not be reused Pulse oximeter finger clip Although unlikely the organisms can also be transmitted by pulse oximetry Therefore the pulse oximeter finger clip should be washed with each patient change using either soapy water or a glutaraldehyde solution Instrunet type RISKS OF INTERFERENCE This is an electronic product and therefore high frequency emissions may interfere with its correct use Therefore keep the spirometer away from products radios cellphones etc that may generate interference REMOVAL OF WASTE FROM ELECTRICAL AND ELECTRONIC APPLIANCES BY DOMESTIC USERS IN THE EUROPEAN UNION This symbol on the product indicates that you cannot
96. n bluetooth etc In the case of the latter SIBEL S A will provide a new update key 5 DATOSPIR MICRO User s Manual 86 In case of the former consult the key in the equipment before starting the update process Switch the DATOSPIR MICRO on and select the following from the main menu MAIN MENU 5 Maintenance Access the option MAINTENANCE 4 Config Equip and consult the update key in CONFIG EQUIP 5 Update Key Stop the DATOSPIR MICRO The updating process is as follows 1 Run the W 20 Spirometry Software and access the Configuration Hardware Test option Run a communications test to check that the connections are correct 2 Switch off the DATOSPIR MICRO 3 Start the DATOSPIR MICRO while keeping the key pressed down This will run the helmed DATOSPIR MICRO User s Manual programme in BIOS to update FLASH 4 The BIOS access key is then requested Press 4 and then gt to prevent any user from being able to access by mistake 5 Copy the new file provided by SIBEL containing the update DMFlash tsk to the FIRMWARE directory of the application W20 6 Run the W 20 Spirometry Software access the Configuration Links option and check that the DATOSPI R MI CRO is selected 7 Access the Configuration Utilities Update Flash option the W 20 Spirometry Software in demo mode provided on purchasing the equipment is enough A dialog
97. n Programme for fast less than one minute and easy checking and auto correcting of diversion in the measurements taken based ona standard or reference volume for the quality control of the different spirometric tests The regularity of calibration depends on the user although normative recommends it be done on a daily or weekly basis CALIBRATION PROCESS The calibration process is as follows 1 Install the spirometer and the syringe as in the figure S be med DATOSPIR MICRO User s Manual MANGUERA REGISTRO JERINGA DE CALIBRACION 2 Start the DATOSPIR MICRO using the key and wait for the following screen to appear MAIN MENU 1 Spirometry 3 With the keys select MAIN MENU 2 Calibration 4 Press gt the following screen will appear CALIBRATION 1 Calibration 67 y 4 5 DATOSPIR MICRO User s Manual 5 Press gt enter the volume of the syringe litres between 0 and 6 litres depending on the syringe CAL DATA Volume 1 x If a O is entered the default factors are used Fct 1 and NPulses 188 and the calibration process is completed NOTE Where no syringe is available the value entered in Volume is not relevant and is not taken into account when automatically calibrating the equipment 6 Press gt The following screen will appear CAL DATA No Pulses xxx If the numbe
98. n do the following after carrying out the FVC test on a patient A test on the same patient An MVV test on the same patient A Post bronchial dilation test on the same patient Print the general report of all tests on the same patient Start the test process on another patient The spirometer saves the best manoeuvre of each FVC VC MVV and or Bronchial dilation test to print a general report where required of them all before going on to another patient CHANGE PATIENT This option is used to change some details of an existing patient or to enter a new patient Press the i key on the test screen to access the patient s details screen Follow the procedure described in the ENTERI NG PATI ENT PARAMETERS procedure to enter the details of a new patient or to modify the details of an existing patient NOTE In the event of having modified some details of an existing patient his parameters will be recalculated taking the changes made into account 5 DATOSPIR MICRO User s Manual 3 5 SLOW VITAL CAPACITY VC TEST PROCEDURE The procedure to carry out the slow Vital Capacity VC test is similar to that described in section 3 4 FORCED VITAL CAPACITY FVC PROCEDURE with the following variations l Access the VC test by pressing the ey 75 from the main screen and perform a manoeuvre 2 The axes are always displayed in VOLUME TIME mode 3 Instruct the patient as to how to the test is
99. nd calibration database Central Processing Unit CPU Communications controller Series USB and Bluetooth with the outside Clock Calendar Alarm PROGRAMME The control programme has been developed in assembler and in top level C language to ensure very fast time control and a structured programme It is divided into two parts the Bios in internal Flash and the application in external Flash MEMORY The storage capacity for temporary data for the customised equipment configuration and for the calibration database is 512 KB in non volatile RAM The test database has a maximum capacity of 1 MByte S be med DATOSPIR MICRO User s Manual CPU This device manages and runs the process that is coded into the data forming the programme The Renesas H8S2144 micro controller is used as a CPU CONTROLLERS These are responsible for transferring data between the CPU and the other devices such as the keypad the screen and the printer They form part of the integrated micro controller circuit except for the RS 232 series communications channel interface and the screen controller QUALITATIVE DESCRIPTION The control programme is responsible for ensuring the spirometry signals are handled in line with the applicable standards particularly the calculation of Identification of the start of expiration The start of the test is determined by the filling of a maximum level of flow of approximately 100ml s althou
100. nd graphs corresponding to the selected curve If you do not want graphs certain parameters the diagnosis and or ATS ERS warnings to appear disable them as described in Section 2 2 EQUIPMENT CUSTOMISATION WARNING REMEMBER THAT THE BEST MANOEUVRE CORRESPONDS TO THE ONE SAVED IN POSITION M1 AND WILL BE SELECTED BY DEFAULT If you want a global printout of the report including the FVC VC and MVV tests made on a patient follow the steps described in the General Report Printing Section The following screen will appear during the printing process PRINTING EEE The top line indicates the percentage of the report produced Printing can be cancelled at any time by pressing the 4 key DELETING A MANOEUVRE MADE DATOSPIR MICRO spirometer deletes any manoeuvre made whether it is because you are doubtful as to whether its values are correct due to a defective performance which may distort the results or because of any other reason The process is similar to that described in the previous section but previously selecting the option Chapter 2 Model A Operating DATOSPIR MICRO User s Manual 56 FVC TEST 7 Delete Press the gt key and similar screen to the following will appear DELETE 1 M2 Select the manoeuvre to delete flashing and press gt The following screen will appear WANT TO DELETE THE MANOEUVRE Press the 4 key to cancel and not delete the
101. nt s details Next view the second group of buttons Back view the first group of buttons Delete the manoeuvre alt Display the manoeuvre diagnosis E Print the manoeuvre report There are other areas of the screen that also have certain functions Pressing on the axes changes the type of graph Flow Volume or Volume Time DATOSPIR MICRO User s Manual 115 e Pressing on the parameters displays the screen containing the data on the selected manoeuvre e Pressing on a manoeuvre selects it This allows you to see its graph consult its parameters or print a report Pressing on the graph area makes the buttons disappear and makes it larger or smaller 1 16 24 93 96 7 ul 1 REF 15 45 4 36 or amp Makes the graph larger or smaller e Pressing on the reference area top part of the screen accesses the patient s details The technician who is going to carry out the forced spirometry tests must know the normal procedures required so that the patient can be coached Otherwise it is recommended to review documentation on the matter S be med DATOSPIR MICRO User s Manual When undertaking spirometry take the following steps into account 1 Check that the turbine is correctly inserted with the mouthpiece as in the figure INSERT FIRMLY 2 Instruct the patient as to how to the test is being carried out as his
102. oeuvre Graph presentation Flow Volume only in FVC Volume Time Manoeuvre selection Select the best manoeuvre Manoeuvre data selected Memory for five manoeuvres Deleting a manoeuvre Diagnosis Saving test for Post bronchial dilation Saving test on the Database Test printout Slow Vital Capacity VC Test Similar to the FVC Maximum Voluntary Ventilation MVV Test Similar to the FVC CALI BRATI ON Calibration using a syringe Report on the latest calibrations DATABASE Search by patient code or register number Summarised display of the tests saved Printing and displaying a test S be med DATOSPIR MICRO User s Manual 100 Deleting a test Summarised printing of the tests saved CUSTOMISATION Standard Configuration Retrieving the configuration Saving the configuration Home mode customisation Patient and test data Database customisation Number of registers Common Customisation Setting the clock Patient code and others Numeric Alphanumeric Battery type Operating language Entering a heading in the report Selecting the printer type Spirometry Customisation Parameters of reference and ethnic factor Observed parameters FVC VC MVV Graph selection Saving graphs on the database Printing FVC Flow Volume graph Printing FVC Flow Time graph Printing VC Flow Time graph Printing MVV Flow Time graph Diagnosis selection Comparison mode in POST bronchial dilation Weighted betw
103. of an existing patient If you have not saved the tests completed to date the following warning will appear after the last screen of data DELETE UNSAVED TESTS If you press 4 the tests completed will be saved the database If you press gt the tests completed will not be saved the database and CANNOT BE RECOVERED All the tests completed will then belong to the new patient NOTE the event of having modified some details of an existing patient his parameters will be recalculated taking the changes made into account 6 DATOSPIR MICRO User s Manual 59 2 5 SLOW VITAL CAPACITY VC TEST PROCEDURE The procedure to carry out the slow Vital Capacity test is similar to that described in Section 2 4 FORCED VITAL CAPACI PROCEDURE with the following variations 1 If the test is carried out on the same patient as described in the OTHER TESTS ON THE SAME PATIENT section go back using the lt key to the Test Selection window and select using keys the VC test SPIROMETRY 2VC If the patient is new begin as described in the ENTERI NG PATIENT PARAMETERS section 2 Instruct the patient as to how to carry out this type of test as his cooperation is vital for it to be completed correctly 3 The maximum time allowed for the manoeuvre is 45 seconds The equipment saves a maximum of five manoeuvres ordered according to the VC value w
104. of the selected manoeuvre press the key One of the following screens will appear depending on the customised diagnosis MILLER QUADRANT DIAGNOSIS ACC SNIDER KORY amp Restrict iMorm LYONS Values within reference margin Normal cmm B Combined Obst ESC Est E x a 40 g 30 120 FVCref MILLER By pressing or respectively you can change diagnosis 5 DATOSPIR MICRO User s Manual MEMORI SI FVC TESTS Memorising a test in the I nternal Database The DATOSPIR MICRO spirometer has an Internal Database that can save different tests which are subsequently transferred to a PC Database This base may be of the L or H depending on its capacity The manoeuvre selected by default is the best M1 If you want to save another it must first be selected Once the manoeuvre to be saved on the database has been selected on the test screen press the key The following screen will appear Press the key The following message will appear indicating that the manoeuvre has been saved MANOEUVRE Wo 4 SAYED Sibel med DATOSPIR MICRO User s Manual 125 Memorising a test to compare it in POST bronchial dilation mode This options allows for a test to be saved in PRE bronchial dilation mode to then compare it with POST bronchial dilation mode The process is similar to that
105. ontact the SIBEL S A Sales Department or your distributor The main feature differentiating Model A from Models B and C is its operating mode Model A works with a 2 line screen in text mode and using 4 silicon keys Models B and C work with a touch screen in graphic mode and using a pointer E IET SS S be tmed DATOSPIR MICRO User s Manual RELACION DE CONTENIDO PACKING LIST CODIGO CODE 511 A00 00_ 511 0 000 511 21 040 510 121 060 501 611 030 140 550 010 511 11 090 511 21 090 305 600 030 321 100 090 511 A30 000 511 AA0 002 511 0 001 511 A00 MU_ 511 8F0 DMO 511 8FA 511 8F0 000 511 850 009 511 850 011 511 AF0 000 305 600 040 511 ABO 000 511 001 511 0 002 365 216 061 CANT QTY MODELOS MODELS DESCRIPCI N A DESCRIPTION DATOSPIR MICRO MODELO MODEL SN 11A CODIGO DESBLOQUEO PUK PERSONAL UNBLOCKING KEY PUK PUNTERO POINTER BOQUILLA CARTON DESECHABLE DISPOSABLE MOUTHPIECE BOQUILLA DE PLASTICO PLASTIC MOUTHPIECE PINZA NASAL NOSE CLIP GUIA RAPIDA DE USO MOD A MOD A QUICK REFERENCE GUIA RAPIDA DE USO MOD B C MOD B C QUICK REFERENCE CONEXION PC USB USB PC CONNECTION LINK CABLE MINI USB 5 PINES USB A PILA AA 1 5V ALCALINA AA 1 5V ALKALINE BATTERY TRANSDUCTOR TURBINA TURBINE TRANSDUCER MALETA DE TRANSPORTE CARRYING CASE Ss CONEXION PC 5232 PC 85232 CONNECTION LINK
106. ory flow with 50 of FVC inspired FIVC I Forced Vital Inspiratory Capacity FIV1 1 Forced Inspirometry Volume in 1 second FIV1 FIVC Ratio FEV1 FIV1 Ratio e PIF 1 5 Inspiratory Flow Apex MTT s Mean Transit Time PEF PIF Ratio Vext 90 Volume extrapolated in relation to FVC MVVInd l min Maximum indirector Voluntary Ventilation 30 x FEV1 FEV6 1 Forced Expirometry Volume in 6 seconds FEV1 FEV6 Ratio rate Parameter that depends on the number of cigarettes smoked a day the age and FEV1 Indicates the risk of EPOC Age of the Lung Parameter that depends on the height and FEV1 Indicates the equivalent age of the lung According to ERS ATS standardisation parameters MEF25 MEF50 MEF75 are replaced by FEF75 FEF50 and FEF25 Diagnosis based on Miller Quadrant Snider Kory amp Lyons Percentage deviation in relation to values of reference Standardised values of reference that can be selected from several standards Patient s I D details Atmospheric data on temperature pressure and relative humidity S be med DATOSPIR MICRO User s Manual 192 Graphs FLOW VOLUME and VOLUME TI ME Warnings of manoeuvre compliance with ATS ERS criteria Saving of five manoeuvres from the same test Acoustic and graphic indication of the start and end of each manoeuvre SLOW VITAL CAPACITY Parameters e VC 1
107. ous section To access this option press CUSTOMISATION in the main menu The following screen will appear CUSTOMISATION 16 05 mnm Exits this screen and goes back to the previous Standard Configuration H E Home mode customisation Database customisation Common customisation Spirometry customisation NE Pulse oximetry customisation 5 DATOSPIR MICRO User s Manual 104 SPIROMETRY CUSTOMISATION This option customises any suboptions specific to the spirometric tests 93 96 96 SPIROMETRY CUST 16 86 Parameters of Reference Allows selecting among several Selects for children and adults Prioritises the age range selected for adults if a different table is chosen for children Extrapolates the values for the ages outside the selected table range Observed Parameters Allows for the observed parameters or measured parameters you want to use to be selected This is only at display level or for the report All the parameters are saved on the database and can be enabled at any time Selecting the graph type Diagnosis Selection according to Miller Quadrant Snider Kory amp Lyons Algorithm NEN S be med DATOSPIR MICRO User s Manual Mode of comparison between PRE bronchial and D POST bronchial W Average weighted between PRE and POST between REF and POST Percentage between PRE and POST Dif Difference between PRE and POST Warn
108. out in FVC VC and MVV provided a test has previously been completed in PRE bronchial dilator mode and saved on the database The purpose of this operating mode is to provide PRE and POST spirometric results of applying a bronchial dilating drug in the same report The procedure to carry out Post bronchial dilating Spirometry is as follows 1 Complete VC or MVV test on the patient before applying the dilating drug as described in the previous sections 2 Memorise the PRE test in the database to compare it in POST mode as explained in MEMORISING FVC TESTS in section 3 4 3 Apply the dosage of bronchial dilating drug established by the specialist to the patient and wait for the standardised period M 4 On the main screen press the key A screen similar to the following will appear which displays the tests memorised in PRE mode 6 DATOSPIR MICRO User s Manual 135 PRE BRONCHIAL TESTS Edell Using keys and the VC and MVV tests can be seen respectively saved in PRE mode 5 Select the PRE test with which it is to be compared and press The screen then shows the two graphs PRE and POST for comparison purposes S be med DATOSPIR MICRO User s Manual 6 Then continue as described in section 3 4 FVC TEST PROCEDURE e In this case the curve in POST bronchial mode is compared with the curve saved in PRE bronchial mode The data screen shows the observed values in
109. pirometer and the syringe as in the figure FS S be rnmed DATOSPIR MICRO User s Manual MANGUERA REGISTRO JERINGA CALIBRACION 2 From the Main screen press the key The following screen will appear INSP Fo 4 084 03 25 06 T Volume Mo Pulzez Pres If there are previous calibrations the details of the last one will appear in the title Enter the necessary data Volume volume of the syringe between 0 and 6 litres depending on the syringe If a O is entered the default factors are used Fct 1 and NPulses 188 and the calibration process is completed No of Pulses number of pulses number printed on the turbine that corresponds to the number of pulses turn If the number of pulses associated to its turbine is as appears on screen continue without modifying it helmed DATOSPIR MICRO User s Manual If it is different enter the number of turbine pulses In this case the following screen will appear Volume N Pulses Check that of pulses is the a same that on the turbina Press and the factors will be calculated and the calibration process completed ESC In case of pressing the number of pulses will not change and will return to the previous screen NOTE Each turbine is factory calibrated individually and is associated to a factor equivalent to the pulses litre detected and p
110. pow 5 DATOSPIR MICRO User s Manual 3 The patient must perform three expiratory manoeuvres and the following screen will appear IM RELATION TO SEMAPHORE MEDIUM MINIMUM Mas IMUM Indicates the value of the manoeuvre relation to the semaphore low medium or good The equipment automatically saves the best manoeuvre in the memory according to the following criteria The one with the best sum of FVC FEV1 is considered the best The one with the best FVC is considered the best The one with the best FEV1 is considered the best The curves with warnings ET EX are considered the worst 4 As a guideline for subsequent control and diagnosis patients can note down where applicable one or several of the different symptoms during the test COUGH PANTING BREATHING DIFFICULTIES or MUCOSITY The severity can be chosen for each symptom from among the following values NONE No symptom LOW MEDIUM HIGH RIT ESI 3 DATOSPIR MICRO User s Manual 179 To do so press go to the next screen or to back to the previous screen Have YOU COUBHED NONE MEDIUM HIGH OOo x YOU MEDIUM HIGH AOL x gt gt HAVE YOU BREATHING OLFFICULTIES NONE MEDIUM HIGH AOL x gt pue g sjapow FS SS
111. private data it contains To comply with current legislation users must enable this option and configure their pins They will be held responsible for providing this pin to the authorised people S 6e med DATOSPIR MICRO User s Manual 229 Thus when the spirometer is started a pin will be requested and the equipment locked where this pin is entered erroneously three times On restarting the equipment the unlock code PUK provided by the manufacturer upon purchasing the equipment will be requested If this code is not available the equipment will remain locked Other important issues e Printing documents In the event of saving paper printouts containing patient details these documents must be properly stored so that only duly authorised personnel have access to them Furthermore in the event of users deciding to dispose of the printed documents their effective physical destruction must be ensured to avoid unauthorised access thereto e Data transmission The DATOSPIR MI CRO spirometer can transmit files containing patient details via PC connection so that work can be subsequently carried out on them using the W20 Spirometry Software This software is also compliant with the Data Protection Act as explained in the W20 Spirometry Software User s Manual pasu 6 T 5 5 lt Sibe lmed PV 2 304 993 YUM z
112. r of pulses associated to its turbine is as appears on screen continue without modifying it If it is different enter the number of turbine pulses In this case press gt and the following message will appear Confirm change in N Pulses DATOSPIR MICRO User s Manual 69 Press gt the factors will be calculated and the calibration process will conclude In case of pressing lt the number of pulses will not change and will return to the previous screen NOTE Each turbine is factory calibrated individually and is associated to a factor equivalent to the pulses litre detected and printed on it Although dispersion among turbines is within 3 itis worth entering this factor in the spirometer if the turbine is changed to obtain the maximum measurement precision Where no syringe is available it is very important to enter the No of Pulses of the turbine so that the equipment can be automatically calibrated 7 Press gt atmospheric temperature C detected will appear thanks to a sensor inside the equipment This can be modified if required CAL DATA Temp 8 Press gt relative humidity entered the last calibration will appear This can be modified if required CAL DATA Humidity xx S be med DATOSPIR MICRO User s Manual 9 Press gt The atmospheric pressure mmHg entered in the last calibration will appear This
113. r rating of the transmitter in watts W according to the transmitter manufacturer and 1 the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range gt Interference may occur the vicinity of equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which Datospir Micro is used exceeds the applicable RF compliance level above Datospir Micro should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such reorienting or relocating Datospir Micro P Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m CISM hands 6 765 795 MHz 13 553 13 567 MHz
114. remain locked This prevents unauthorised access to the equipment and more specifically to the private data it contains pue SjJapow S be med DATOSPIR MICRO User s Manual 3 4 FORCED VITAL CAPACITY TEST PROCEDURE The procedures to be completed to carry out the Forced Vital Capacity FVC slow Vital Capacity VC and Maximum Voluntary Ventilation MVV tests are very similar Therefore only one detailed description will be given in this section ENTERI NG PATIENT PARAMETERS Start the DATOSPIR MICRO using the wait the main screen to appear and press the key One of the following screens will appear depending the mode selected numeric or alphanumeric 123456785 2123456783 0 tech _____ SUE L L age e 2e a 9 iav 3141515 The meaning of each field is as follows Cod Code 10 character numeric or alphanumeric field depending on the customised option corresponding to the patient code Tec Technician 10 character numeric field corresponding to the code of the technician carrying out the test Sibelmed DATOSPIR MICRO User s Manual 113 Yrs Age Number corresponding to the age between 4 and 100 cm Height Heigh
115. rent options of the equipment to be configured and v select CONFIG EQUIP 1 Reset to reset all equipment variables Using keys gt CONFIG EQUIP 2 Reindex to reindex the database CONFIG EQUIP 3 Calibration to enter the turbine pulses CONFIG EQUIP 4 VC mode to choose the presentation mode for the VC curve Normal expiration upwards Inverted expiration downwards DATOSPIR MICRO User s Manual 83 CONFIG EQUIP 5 Update Key JePOW to consult the updating key for the programme in Flash ATS CURVES Select the option MAINTENANCE 5 Standard Curves This option checks the correct working order of the equipment using pre saved curves and select STANDARD CURVES 1 FVC Using keys gt STANDARD CURVES STANDARD CURVES 3 MVV N lt Select the option and following the instructions on the screen which are similar to the FVC VC and MVV procedures With these curves you can operate the equipment as if they were real patient curves with slight exceptions 5 DATOSPIR MICRO User s Manual 84 2 11 UPDATING INTERNAL SOFTWARE The DATOSPIR MICRO spirometer has two types of internal software Bios basic hardware control programme Flash programme containing all the equipment options The update option allows for the version of Bios and or Flash to be updated without having to tak
116. rinted on it Although dispersion among turbines is within 3 itis worth entering this factor in the spirometer if the turbine is changed to obtain the maximum measurement precision Temp ambient temperature in 9C detected by a sensor inside the equipment This can be modified if required HR relative humidity in 9o entered in the last calibration This can be modified if required Pres atmospheric pressure in mmHg entered in the last calibration This can be modified if required 5 DATOSPIR MICRO User s Manual 3 Press If a Volume other than 0 has been entered and the No of Pulses has not bee modified the following screen will appear 4 Press and start the calibration process emptying the syringe for two or more consecutive cycles one cycle is equal to emptying and refilling the syringe When emptying and filling the syringe plunger must move all the volume used as a reference If this is not done correctly the equipment will detect it as incorrect manoeuvres Furthermore this process should be completed in a regular and uniform manner without causing flow rates that are too high or too low Where this is not the case you will be told to repeat the manoeuvre The time for each cycle must be no less than three seconds and no more than six 5 The screen shows the expiratory and inspiratory factors taken by the equipment and if they are within 296 will consider the system calibrated
117. s Home mode Patient details test data Printers Standard curves Retrieve standard modify standard Battery Language Set clock Time Date Pulse oximetry Calibration Internal Database to save tests with alphanumeric and graphical data depending on model Maintenance Warnings LCD contrast Equipment check Equipment configuration ATS curves Function modes Home Hospital Pulse oximetry Bluetooth DATOSPIR MICRO User s Manual 2 MODEL A OPERATION epow z 2 6 DATOSPIR MICRO User s Manual 30 All of the sections in this Chapter except for 2 12 HOME MODE OPERATIONS refer to HOSPI TAL MODE 2 1 FUNCTION TREE The DATOSPI R MICRO spirometer function tree is shown for a better understanding of its structure This structure corresponds to Model A and is characterised by the fact that it contains text menus The DATOSPIR MI CRO Model A has 4 silicon keys located underneath the screen to move around the different menus in the equipment In general the and v keys enable you to move around the different menu options The gt key provides access to the selected option the lt key takes you back to the previous menu The following can be accessed from the Main Menu depending on the options included SPIROMETRY CALIBRATION DATABASE CUSTOMISATION MAINTENANCE
118. shape of the stators means that the air flow passing turns which makes the blade turn The turbine operates based on the Fluid Mechanics theory and more specifically the Machine Turbo theory Applied to this case the angle at which the rotor turns is directly proportional to the fluid volume crossing the turbine and the proportionality constant depends on its shape 6 2 TURBINE ROTATION SENSOR The turbine rotation sensor consists of three pairs of emitting diodes and an infrared invisible photo transistor that appropriately positioned detect the rotation and its direction The number of times the beam is interrupted is equivalent to an accumulated angle of rotations and therefore the voluem of air to have crossed the turbine The photo transistor provides a digital electrical signal that represents the times the beam of light is interrupted and is directly acquired by the microprocessor Sibel med DATOSPIR MICRO User s Manual 203 6 3 MICROPROCESSOR PHYSICAL DESCRIPTION The microprocessor system is made up of a series of electronic devices that save manage receive and send data In general terms it is divided into Basic hardware control programme BIOS residing in the internal Flash of the Micro controller 128 KBytes Spirometry and equipment management programme and test database residing in the 2 MByte FLASH memory Non volatile 512 KByte RAM memory to save the equipment configuration status variables a
119. stomises certain suboptions that are common to any test made using the DATOSPI R MI CRO 83 86 86 COMMON CUST 16 09 83 86 86 COMMON CUST 16 Es 4 8 ES Sets the internal equipment clock time and date Pu or on Mode alphanumeric or numeric Battery type alkaline or NiMh or D This selection only affects the calculation made inside the equipment to indicate the battery level Operating language Enter a heading in the report This allows inserting two heading lines with a maximum of 33 characters line This can include the name of the hospital the doctor etc and will appear in each report E E Printer type Protection customisation PIN o 0 S be med DATOSPIR MICRO User s Manual PULSE OXIMETRY CUSTOMISATION SpO module is an option included in the DATOSPIR MICRO Each user should customise it to suit their needs See section 3 8 PULSE OXI METRY TEST PROCEDURE EQUIPMENT PROTECTION CUSTOMISATION This allows you to change the PIN required to start the equipment if the protection option is enabled and to enable or disable equipment protection The pin code must be of 4 digits The following screen appears on accessing this option CHANGE Current Pin Pin Enabled New Pin Mew Pin 1 2134 enable the protection tick the Pin Enabled checkbox and enter the PIN in the New Pin boxes
120. structions PRECAUTI ON DO NOT EXPOSE THE TURBI NE TO TEMPERATURES OF OVER 60 OR BELOW DO NOT USE SOLVENTS OR OTHER SIMILAR SUBSTANCES FOR CLEANI NG AS THEY MAY DAMAGE IT SPIROMETER The spirometer is cleaned gently with a dry cloth or a cloth dampened slightly with soapy water with any remains of water then being dried Pay special attention to ensure no liquid enters the inside or connectors and connections Do not use abrasive substances or solvents WARNING Remove the batteries from their compartment before cleaning PULSE OXI METRY FINGER CLIP Although unlikely the organisms can also be transmitted by pulse oximetry Therefore the pulse oximeter finger clip should be washed with each patient change using either soapy water or a glutaraldehyde solution Instrunet type 5 DATOSPIR MICRO User s Manual 218 8 2 PREVENTATIVE MAINTENANCE Preventative maintenance consists of any actions aimed at keeping the equipment in a good state of repair Four types of preventative maintenance are established 1 Every time it is started the equipment will check certain parts 2 Asecond type which can be performed by the user consists of the regular monitoring of the appearance of the different connections and other external parts of the equipment Check that all connections are perfectly connected that no cable and or connector or any other element is broken or damaged In the event of detecting
121. t To select another manoeuvre press the keys or v Therefore the brackets and the flashing text do not have to match On accessing the results of a test the best FVC mFVC and the best FEV1 mFEV1 will appear first followed by the results of the selected manoeuvre The best FVC and FEV1 values may correspond to any of the available manoeuvres DATOSPIR MICRO User s Manual TYPE OF DIAGNOSIS The DATOSPIR MICRO spirometer has two types of diagnosis that can be selected in the Customisation Programme NOTE If you do not agree with these two criteria do not use them as a reference The diagnosis and the results of the test must always be validated by the specialist Miller Diagnosis This presents the following information NORMAL RESTRICTIVE OBSTRUCTIVE or COMBINED according to the criteria of the following chart MILLER QUADRANT Restrictive Normal Combined 20 48 68 88 188 128 FUC FUCref 72 Snider Kory amp Lyons Diagnosis This is based on the following criteria If FVC gt 80 of the FVC Reference and FEV1 gt 80 of the FEV1 Reference Values in the range of reference Normal Diagnosis If FEV1 FVC FEV1 FVC Reference and FEV1 80 of the FEV1 Reference Obstructive ventilatory disturbance 6 DATOSPIR MICRO User s Manual 50 FEV1 lt 80 Slight FEV1 lt 65 Moderate FEV1 lt 50 Intense F
122. t in cm between 50 and 230 kg Weight Weight in kg between 15 and 200 9 Sex Between male and female C Cigarettes day Between 0 and 100 cigarettes Smkl Smoker index Between 0 200 packets day multiplied by the number of years The Smoker Index is the same as the number of cigarettes smoked a day divided by 20 and multiplied by the number of years smoking cigarettes day x years smoking 20 EtF Ethnic factor Between 80 and 120 The ethnic factor is used in areas without their own reference parameters and using some which exist but which are corrected to a specific percentage This factor MUST BE SET TO 100 IF NOT USED and can only be modified through the Customisation Programme Nam First name 20 character alphanumeric field corresponding to the patient s name This can be omitted if you wish Sur Surnames 25 character alphanumeric field corresponding to the patient s surnames This can be omitted if you wish In alphanumeric fields Forename Surname Code etc a double click on the field can fully delete it Enter the patient s details and press the key to go to the test screen i 12 Jiles 1 14 eel 4 2 2 123 45 6 T amp iol ESC Go back to the previous screen Start the manoeuvre BE Save the manoeuvre on the database EG Modify the patie
123. t the SI BEL S A After Sales Service and specify the problem in as much detail as possible pue deexdp 8 193deu 5 5 gt Y 2 9 x lt Sibe lmed 9AIZIIIIOD pue dee xdp 8 193deu 5 6 DATOSPIR MICRO User s Manual 221 APPENDIX 1 ELECTROMAGNETIC COMPATIBILITY Ayupigqneduio xipueddy Electromagnetic Compatibility Appendix 1 Sib elmed DATOSPIR MICRO User s Manual Guidance and manufacturer s declaration electromagnetic emissions Datospir Micro is intended for use in the electromagnetic environment specified below The customer or the user should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment Guidance RF Radiated emissions Group 1 Datospir Micro uses RF energy only for its internal function Therefore its RF emissions are very low CISPR 11 EN 55011 and are not likely to cause any interference in nearby electronic equipment RF Conducted emissions Not applicable Datospir Micro works with batteries DC USB CISPR 11 EN 55011 power Harmonic emissions EN IEC 61000 3 2 Not applicable Datospir Micro works with batteries DC USB power Voltage fluctuations Flicker
124. t two of FEV1 differ in no more than 150 ml if the FVC is greater than 1 litre or in no more than 100 ml if the FVC is below or equal to one litre NOTE Remember that the back key takes you back in the menu without losing the information available to date except where you change patient ATS ERS criteria The manoeuvre with least warnings is considered the best ET EX With the same number of warnings the manoeuvre with the highest value sum of 1 is considered the best DI SPLAYI NG RESULTS The results can be seen once at least one manoeuvre has been completed To do so go back to the following screen FVC TEST 1 Start Manoeuv and using the or v keys select the option FVC TEST 2 Results S be med DATOSPIR MICRO User s Manual Press the gt key a similar screen to the following will appear RESULTS 1 M2 M3 M5 Indicates the number of manoeuvres in the memory The best M1 will always be selected flashing text by default This screen indicates the following Number of manoeuvres on memory There may be from one to five manoeuvres The manoeuvres are ordered according to ATS ERS criteria explained in the previous section with M1 the best and M5 the worst The manoeuvre between brackets M3 indicates the position taken by the last manoeuvre entered The flasing text indicates the manoeuvre selected To display the results press g
125. the patient as to how to carry out this type of test as his cooperation is vital for it to be completed correctly 3 The maximum time allowed for the manoeuvre is 15 seconds The equipment saves a maximum of three manoeuvres ordered according to the MVV value where M1 is the best MVV and M3 the worst 4 The register of parameters and graphics is as shown below Model A Operating Chapter 2 Sibelmed DATOSPIR MICRO SIBEL S A ROSSELLO 500 08026 BARCELONA PULMONARY FUNCTION TEST DATOSPIR MICRO Code 0000000001 Date 03 22 2006 Time 17 52 Name Sex 26 Height 174 Wt Kg 68 Temp C 26 Pres mmHg 760 Humidity 60 Smok I 0 References SEPAR Ethnic 100 Reason Origin Technician Bios Ver 5115AB 1 00 Prog Ver 5115AF 1 00 MVV REPORT MANOEUVRE No 1 1 PARAMETER OBS REF 5 MVV 1 10 150 82 179 00 84 Br min 44 12 helmed DATOSPIR MICRO User s Manual 2 7 POST BRONCHIAL DILATOR SPIROMETRY PROCEDURE The DATOSPI MICRO spirometer allows for Post bronchial dilation tests to be carried out in FVC VC and MVV provided a test has previously be completed in PRE bronchial dilator mode and saved to the database The purpose of this operating mode is to provide PRE and POST spirometric results of applying a bronchial dilating drug in the same report The procedure to carry out Post bronchial dilating Spirometry is as follows
126. ting the parameters and Test Time To obtain a report on the study performed press gt 7 S Ge med DATOSPIR MICRO User s Manual Sibelmed DATOSPIR MICRO SIBEL S A ROSSELLO 500 08026 BARCELONA PULSE OXYMETRY TEST DATOSPIR MICRO Code 0000000001 Date 03 22 2006 Time 18 01 Name Sex Male 26 Height cm 174 Wt Kg 68 Reason Origin Technician Bios Ver 5115AB 1 00 Prog Ver 5115AF 1 00 PARAMETER OBS CT90 25 6 CT80 13 4 CT70 5 8 0 IDH 4 10 3 IDH 3 18 3 IDH 2 24 3 SpO2 Max 97 0 5002 93 3 202 Min 81 0 Std 5 3 2 BPM 125 0 75 6 BPM Min BPM 65 0 BPM Std BPM 12 8 Test Time 02 01 32 193deu5 3 pue 5 Chapter 3 Models Operation S be med DATOSPIR MICRO User s Manual TEST TRANSFER As with spirometric tests the pulse oximetry tests saved to the database can be transferred to a PC Remember that only parameters are saved not the curve PULSE OXIMETRY MEASUREMENTS It is possible to take pulse oximetry measurements while performing a spirometry test only in FVC and VC tests To do so the pulse oximetry finger clip must be connected when starting the spirometry While spirometry is being performed the Saturation SpO and Pulse Rate PR value will appear on the screen with the curve and will be saved in the
127. tor Sales Director Declaration of Conformity S be med DATOSPIR MICRO User s Manual p 4 qu Sibelmed DATOSPIR MICRO User s Manual SAFETY SPECIAL PRECAUTIONS The DATOSPIR MICRO spirometer has been designed for use with the utmost safety All operating instructions must be read before using the DATOSPIR MICRO Not doing so may lead to injuries to the user or the patient and damage to equipment and or accessories INTENDED USE The spirometer measures and calculates a series of parameters related to the human respiratory function The spirometer is designed for use by medical staff and by the patient when supervised and instructed by a doctor The spirometer is not designed for use outdoors or under other conditions or using other power sources not indicated in this manual In hospital mode the DATOSPIR MICRO is a complete spirometer and users may fully configure the instrument In home mode patients may only switch the equipment on blow and switch it off The doctor must have previously configured this mode before prescribing use of the instrument EFFECTS ON PATIENTS USING THE SPIROMETER The spirometry tests require patient cooperation Complete forced expiration is required to obtain significant patient FVC values The doctor must assess the patient s capacity to undertake spirometry tests Special attention must be paid to children the elderly and the disabled LIMITATIONS OF USE CONTRA
128. tracing of the graph The start must produce a clean sudden deflection the progress itself will draw a gentle upwards concave curve without rectifications and the end must be asymptotic and not perpendicular or sudden Volume Time The expired volume measured during a forced manoeuvre will be influenced by the selecting of its starting point This means that a manoeuvre starting criterion must be chosen and maintained consistently The so called retrograde extrapolation is the most consistent and accepted method by European and American laboratories and will be chosen unless other methods are shown Sibe med DATOSPIR MICRO User s Manual 209 to be similar to have equivalent results The volume extrapolated using this method must be below 5 of the vital capacity or 150 ml without exceeding either of the two criteria To ensure good spirometry the technician will pay particular attention to ensure that the patient has made the utmost effort that the start has been good and that no coughing or Valsava s manoeuvre due to glottis closure has occurred Special attention must be paid to preventing expiration from ending too soon which would be detected in the end of the curve which would be too perpendicular to the horizontal base line Sometimes the patient inadvertently partially obstructs the mouthpiece with his tongue or false teeth It is essential that the best two expirations from the best three acceptable curves do not vary
129. ty and precision of the functions for which it has been developed All this leads to a series of routines that must be completed 8 1 UPKEEP Upkeep is aimed at ensuring the correct working order of the equipment The person undertaking it requires no special technical skills except knowledge of the functions and handling of the equipment The equipment user himself must normally perform this The operations to be completed are as follows CLEANI NG THE TURBI NE TRANSDUCER Given that the turbine is the part exposed directly to the patient it must be kept in perfect physical and hygienic conditions To do so proceed as follows l Theturbine is removed from the equipment housing by pressing slightly so that is comes away from its fixtures 2 Wash the turbine with water and soap avoiding solvents or abrasive substances that may damage the components Given that its reliability depends on the condition of the turbine make sure it is not damaged 3 Once rinsed avoid salt deposits by rinsing again with distilled water 4 You can then leave it to dry at room temperature Sibe med DATOSPIR MICRO User s Manual 217 5 Reassemble the turbine in the housing Top level disinfection If you suspect microbial contamination use one of the more complex antiseptic solutions or sterilisation procedures For example replace Step 2 by submerging it in a glutaraldehyde solution or similar for 10 minutes follow the manufacturer s in
130. ue box will open where the update key that previously consulted if this is a version update or that provided by SIBEL if it is an option update must be entered 8 The new programme will be transmitted The process may take around 10 minutes depending on the PC 9 Switch off the DATOSPIR MICRO S belmed DATOSPIR MICRO User s Manual 88 2 12 HOME MODE OPERATI ONS The DATOSPIR MI CRO spirometer is very useful to monitor and control asthmatic patients or others to suit the specialist s criteria whether they are at home or in hospital In this option the spirometer is extremely user friendly equipment as the sequence of instructions on the screen will guide patients during spirometric manoeuvres In turn it automatically saves the best manoeuvres made in the different tests to memory This enables the specialist to subsequently analyse them and make the corresponding diagnosis Itis also possible to transfer them from the equipment Database to the PC Database using W20 Spirometry Software Three stages can be described for a better understanding of this operating mode l Spirometer configuration 2 Acquisition of spirometric tests 3 Displaying of the information saved CONFI GURATI ON The specialist must configure the spirometer in HOME mode and provide the patient with the necessary instructions The process to follow is as described below Start the DATOSPIR MI CRO using the key and wait for the following screen to app
131. ufacturer or authorised distributor in order to ensure the correct working order of the spirometer MANUFACTURER S LI ABILITY SIBEL S A is only liable for the safety reliability and working order of this equipment if The place where the equipment is installed or used is compliant with the requirements related to the IEC electrical installation and other applicable regulations e All repairs services and modifications inside and outside the guarantee period are carried out by SIBEL S A technical staff The equipment is used by skilled staff according to the recommendations of this User Manual Chapter 1 Instructions for Use and nstallation S be tmed DATOSPIR MICRO User s Manual 20 1 4 LAYOUT OF CONTROLS PILOT LIGHTS AND CONNECTORS MODEL A 1 On off button 2 Alphanumeric LCD display 3 Keypad 4 Turbine transducer 5 USB connection 6 RS 232 series connection 7 Specifications plate 8 Lithium battery CR1632 9 Firmware loading switch 10 Main batteries 2xAA 1 5V S Ge med DATOSPIR MICRO User s Manual MODEL 1 On off button 2 Graphic LCD display 3 Turbine transducer 4 USB connection 5 RS 232 series connection SpO Connection 6 Specifications plate 7 Lithium battery CR1632 8 Firmware loading switch 9 Main batteries 2xAA 1 5V 5 pue esf 0132 435 493deu 5 DATOSPIR MICRO User s Manual
132. ust be reproduced together or separately Along these lines the syringes holding several litres provide a suitable signal and the flow generators can be used to assess the precision and errors in flow measurement Among the most suitable calibration appliances is the so called explosive decompressor which consists of a 4 or 5 litre pressurised one atmosphere chamber fitted with a fast opening for the sudden expulsion of an identical volume to that of the chamber This simulates the forced expiration of a person and with suitable resistances at different levels of obstruction fitted to the output tube the signal is similar to that of a patient with slight moderate or severe obstruction in the air flow Hence the volume and flow measurement can be examined If this is not possible the working order of the appliance must be checked using control individuals i e people close to the laboratory and whose cooperation is attainable to carry out correct spirometry with easy and scarce variability Table I so that their spirometry can be regularly reproduced and compared with the previous data Hence errors can be detected that would have to be significant in size as the variability of spirometry itself prevents small differences in the measuring of volume and flow from being detected see Table D Under normal working conditions calibration using the volume signal provided by a manual syringe will be performed on a daily basis The sign
133. w 90 of time in which SpO is below 80 CT70 of time in which SpO is below 70 IDH 4 Desaturation index gt 4 per hour IDH 3 Desaturation index gt 3 per hour IDH 2 Desaturation index gt 2 per hour Maximum SpO Maximum Saturation value Average SpO Average Saturation value Minimum SpO Minimum Saturation value Std SpO Standard Saturation value Maximum PR Maximum pulse rate value Average PR Average pulse rate value Minimum PR Minimum pulse rate value Std PR Standard pulse rate deviation Test Time Useful test time when the finger clip is disconnected is not considered CALI BRATI ON Calibration programme for dynamic tests with syringe of 1 to 6 litres in volume Register of the latest calibrations Where required calibration warning CUSTOMI SATION PROGRAMME User selected STANDARD configuration Srbelmed DATOSPIR MICRO User s Manual Customisation of the language printer and report heading etc Spirometry customisation Parameters of reference Observed parameters Graph selection Diagnosis selection Report customisation Pulse oximetry customisation INTERNAL DATABASE Saving of spirometric and pulse oximetry tests Two types of database according to their storage capacity CLOCK CALENDAR Hour Minute Second Day Month Year 5 2 MEASURING SYSTEM TYPE OF TRANSDUCER Turbine type transducer with axial type two way volumetrics with
134. xipueddy S be med DATOSPIR MICRO User s Manual MODIFICACIONES v Audi metro Clinico APPENDIX 3 MODIFICATIONS xipueddy Appendix 3 Modifications S be rnmed DATOSPIR MICRO User s Manual
135. y Calculates and displays the value of the parameters Starts or stops saving a study Accesses the Trends screen 3I Ee IEEE E Accesses the patient details screen e SPECIFIC TESTS In specific pulse oximetry studies the screen will indicate the SpO and PR values according to the average configured In order to print the results you must first save the signal by pressing during the period required and then following the instructions given in the PRINTING AND OR MEMORISING ON THE DATABASE section DATOSPIR MICRO User s Manual 143 LONG TERM TESTS In long term tests press the same button to begin saving flashing message SAVING will appear in the centre of the screen to indicate that the study is being saved It is important to note that the signal is related to the patient code entered If the study is started or stopped without having previously changed the patient code or without deleting the study fragments of signal will be saved one after the other until the 8 hours are completed The equipment will interpret that all the fragments correspond to the same patient and the parameters will be calculated on the total memory If you want to perform the test on another patient you must delete the test by pressing and change the patient s details by pressing Wl To calculate the parameters press If the finger clip is disconnected the periods in which the SpO
136. ys between calibrations or between preventative maintenance work on the equipment to be defined If the days specified without calibration or maintenance are exceeded the equipment warns of such by displaying a sign every time it is started If O days is entered a warning is never given Press gt and the next screen will appear to enter the calibration period Calibration Period x Press gt and the next screen will appear to enter the maintenance period Maintenance Period xxx Press gt and an informative screen will appear with the date of the last maintenance work Press gt and informative screen will appear with the total number of tests completed Press gt and informative screen will appear with the number of tests completed since the last maintenance work 7 SSI DATOSPIR MICRO User s Manual 79 LCD CONTRAST Select the option MAINTENANCE 2 LCD contrast Using keys and 7 this option enables you to configure the screen contrast EQUIPMENT CHECK Select the option MAINTENANCE 3 Equip Check This option allows for different parts of the equipment to be checked and select EQUIPMENT CHECK 1 Ext Printer Using keys gt to check the external printer selected SIBELMED logo will be printed along with the heading lines and 10 lines of characters EQUIPMENT CHECK 2 ADCs JePOW
137. ystem S be med DATOSPIR MICRO User s Manual 188 4 4 SPIROMETRY SOFTWARE W 20 FOR PC See the W 20 Spirometry Software User s Manual for all related information S Ge med DATOSPIR MICRO User s Manual 1 5 TECHNICAL SPECIFICATIONS 39 Chapter 5 Technical Specifications S be med DATOSPIR MICRO User s Manual 190 The specifications given below are applicable in each case depending on the model available as indicated in detail in Section 1 3 SPI ROMETER MODELS 5 1 TYPES OF TEST FUNCTIONS AND PARAMETER 5 FORCED VITAL CAPACITY FVC Parameters FVC FEV 5 FEV1 FEV3 FEV 5 FVC FEV1 FVC FEV3 FVC FEV1 VC PEF FEF75 FEF50 FEF75 FEF25 75 FEF75 85 FET25 75 FET100 FEF50 FIF50 FEV1 FEV 5 FEV1 PEF 1 1 1 1 1 5 1 5 Forced Vital Capacity Forced Expirometry Volume in 0 5 seconds Same in 1 second Same in 3 seconds Ratio Ratio Ratio Ratio Flow Apex Maximum Expiratory Flow with 75 of FVC remaining in the lungs 1 5 1 5 1 5 1 5 5 5 Same with 50 of FVC Same with 25 of FVC Forced mesoexpiratory flow Average flow between 75 85 of FVC Time passed between 25 75 of Forced Expiratory Time Ratio Ratio Ratio Sibel med DATOSPIR MICRO User s Manual FIF5090 1 5 Maximum Inspirat

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